CN106606820A - Electrical stimulation device - Google Patents

Electrical stimulation device Download PDF

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Publication number
CN106606820A
CN106606820A CN201610323066.3A CN201610323066A CN106606820A CN 106606820 A CN106606820 A CN 106606820A CN 201610323066 A CN201610323066 A CN 201610323066A CN 106606820 A CN106606820 A CN 106606820A
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CN
China
Prior art keywords
electrical stimulation
signal
amplifier
electrode
pulse wave
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Granted
Application number
CN201610323066.3A
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Chinese (zh)
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CN106606820B (en
Inventor
张季衡
潘建豪
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JINGNENG MEDICAL SCIENCE Co Ltd
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JINGNENG MEDICAL SCIENCE Co Ltd
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Priority claimed from US14/925,379 external-priority patent/US10086201B2/en
Application filed by JINGNENG MEDICAL SCIENCE Co Ltd filed Critical JINGNENG MEDICAL SCIENCE Co Ltd
Priority to US15/299,723 priority Critical patent/US10765868B2/en
Priority to AU2016250332A priority patent/AU2016250332A1/en
Priority to EP16195269.2A priority patent/EP3159038B1/en
Publication of CN106606820A publication Critical patent/CN106606820A/en
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Publication of CN106606820B publication Critical patent/CN106606820B/en
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    • 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
    • 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
    • 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
    • A61N1/36021External stimulators, e.g. with patch electrodes for treatment of pain
    • 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
    • A61N1/36046Applying electric currents by contact electrodes alternating or intermittent currents for stimulation of the eye
    • 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
    • A61N1/3605Implantable neurostimulators for stimulating central or peripheral nerve system
    • 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
    • A61N1/3605Implantable neurostimulators for stimulating central or peripheral nerve system
    • A61N1/3606Implantable neurostimulators for stimulating central or peripheral nerve system adapted for a particular treatment
    • A61N1/36067Movement disorders, e.g. tremor or Parkinson disease
    • 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
    • A61N1/3605Implantable neurostimulators for stimulating central or peripheral nerve system
    • A61N1/3606Implantable neurostimulators for stimulating central or peripheral nerve system adapted for a particular treatment
    • A61N1/36071Pain
    • 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
    • A61N1/3605Implantable neurostimulators for stimulating central or peripheral nerve system
    • A61N1/36125Details of circuitry or electric components
    • 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
    • A61N1/3605Implantable neurostimulators for stimulating central or peripheral nerve system
    • A61N1/36128Control systems

Abstract

The invention discloses an electrical stimulation device, applied to electrically stimulate a target region of a living body. The device comprises a control unit and an electrical stimulation unit. The electrical stimulation unit comprises a frequency synthesizer, an amplifier, a variable resistor, at least a first electrode and at least a second electrode. The frequency synthesizer is coupled with the control unit, and generates frequency signals. The amplifier is coupled with the frequency synthesizer. The variable resistor has resistance value, and is coupled with the control unit and the amplifier. The first electrode and the second electrode are coupled with the amplifier. The amplifier outputs an electrical stimulation signal according to a frequency signal of the frequency synthesizer and the resistance value of the variable resistor, so that the first electrode and the second electrode generate an electric field. The range of the electric field covers a target region, and range of the electric field is between 100 V/m and 5000 V/m, so as to electrically stimulate the target region.

Description

Electrical stimulation device
Technical field
The present invention is with regard to a kind of electrical stimulation device.
Background technology
The conducting path of the instruction (electric current) sent primarily as brain by human nerve.Human nerve has Have threshold values, when nerve damage, its threshold values would generally be reduced, human body also thus easily experience nerve damage The pain at position.If not treated in time at nerve damage, chronic pain disorders will be formed.
To mitigate the pain of chronic pain disorders patient, electricity irritation is common therapeutic modality.At present, suffer from Person is after electronic stimulation, though pain temporarily can be mitigated, maintains the time of this comfort not long, Therefore patient need to continually carry out electricity irritation, can just be maintained at comfortable state.
In addition, with the progress of electrical stimulation technology, also meet the tendency of for the electrical stimulus patternses of various different symptoms and It is raw, for example:Spinal nerve electricity irritation may be used to the diseases such as treatment paralysis, paralysis;Cerebral cortex electrical stimulation can To treat Parkinsonism;Nervi vesicales inferiores electricity irritation may be used to solution apoplexy, paralysis patient and cannot arrange naturally The problem of urine, and avoid the complication that may subsequently cause;Retina neural electricity irritation can then make blind trouble Person experiences faint light and coarse picture again.For different application modes, electrical stimulation signal can Different electric fields, voltage, electric current, persistent period and frequency can be needed.
The content of the invention
The purpose region of electricity irritation organism, including control are applied to according to a kind of electrical stimulation device of the present invention Unit and electrical stimulation unit.Electrical stimulation unit, including frequency synthesizer, amplifier, variable resistance, extremely A few first electrode and at least one second electrode.Frequency synthesizer couples control unit, and produces frequency Signal.Amplifier couples frequency synthesizer.Variable resistance has resistance value, and couples control unit and amplification Device.First electrode and second electrode coupling amplifier.Amplifier according to frequency synthesizer frequency signal with can Become the resistance value output electrical stimulation signal of resistance, make first electrode electric field be produced with second electrode.Field regime Cover the scope of purpose region and electric field intensity between 100V/m~5000V/m, electricity is carried out to purpose region Stimulate.
In one embodiment, electrical stimulation device further includes at least one first electrode and at least one second electric Pole, at least one first electrode and at least one second electrode are coupled to mixer, and electrical stimulation signal makes first Electrode and second electrode produce an electric field, the scope of electric field cover the scope of purpose region and electric field intensity between 100V/m~5000V/m.
In one embodiment, electrical stimulation device further includes at least one first electrode and at least one second electric Pole, at least one first electrode and at least one second electrode are coupled to mixer, and electrical stimulation signal makes first Electrode and second electrode produce electric field, and the scope of electric field covers the scope of purpose region and electric field intensity between 100 V/m~5000V/m.
In one embodiment, frequency synthesizer couples the input of amplifier.
In one embodiment, variable resistance couples the input of amplifier.
In one embodiment, variable resistance couples the outfan of amplifier.
In one embodiment, electrical stimulation unit further includes wave filter, is coupled in frequency synthesizer and amplifier Between.
In one embodiment, electrical stimulation unit further includes detector, coupling control unit and amplifier, and Detecting electrical stimulation signal.
In one embodiment, electrical stimulation unit further includes surge protecter, its coupling amplifier.
In one embodiment, electrical stimulation device is implantation type electric stimulation device.
In one embodiment, the frequency of electrical stimulation signal is between 200kHz to 1000kHz.
In one embodiment, the voltage of electrical stimulation signal is two-phase (bi-phase) property, and its absolute value Jie In 3V to 10V.
In one embodiment, the second pulse wave signal is essentially the postpones signal of the first pulse wave signal.
In one embodiment, the amplitude of the first pulse wave signal is unequal with the amplitude of the second pulse wave signal.
In one embodiment, there is time difference between the first pulse wave signal and the second pulse wave signal.
According to a kind of electrical stimulation method for embedded type device of the present invention, with the purpose of electricity irritation organism Region, the embedded type device include frequency synthesizer, variable resistance and at least one first electrode and extremely A few second electrode, electrical stimulation method are included:Frequency signal is produced using frequency synthesizer;According to frequency The frequency signal of synthesizer exports electrical stimulation signal with the variable-resistance resistance value;And utilize at least one Individual first electrode and at least one second electrode export electrical stimulation signal so that first electrode and second electrode Electric field is produced, field regime covers the scope of the purpose region and electric field intensity between 100V/m~5000 V/m, to carry out electricity irritation to purpose region.
In one embodiment, the frequency of electrical stimulation signal is between 200kHz to 1000kHz.
In one embodiment, electrical stimulation method is further included:The first pulse wave signal and the second pulse wave signal are produced, And Bipolar pulse wave signal is exported according to first pulse wave signal and the second pulse wave signal.The amplifier foundation Bipolar pulse wave signal, frequency signal export the electrical stimulation signal, and the first arteries and veins with variable-resistance resistance value Difference between the integrated value of the amplitude versus time of the integrated value of the amplitude versus time of ripple signal and the second pulse wave signal Value is not more than the 10 of the integrated value of the amplitude versus time of the first pulse wave signal.
In one embodiment, the second pulse wave signal is essentially the first pulse wave signal postpones signal.
In one embodiment, the amplitude of the first pulse wave signal is unequal with the amplitude of second pulse wave signal.
In one embodiment, there is time difference between the first pulse wave signal and second pulse wave signal.
As described above, the electrical stimulation device of the present invention makes electricity irritation by positive and negative phasic property composite signal staggeredly The charge polarity balance of signal, the probability for thus avoiding electrical stimulation signal from working the mischief nerve, electricity irritation Device can carry out appropriate electricity irritation to patient in response to the different electrical stimulation signals for needing to provide different qualities Treatment.
Description of the drawings
Figure 1A is the enforcement schematic diagram that the electrical stimulation device of the embodiment of the present invention is applied to dorsal root ganglion.
Circuit box schematic diagrams of the Figure 1B for the controller of the electrical stimulation device and collocation of Figure 1A.
Fig. 1 C and Fig. 1 D is respectively the close-up schematic view of the wire shown in Figure 1A.
Fig. 2A and Fig. 2 B are the form schematic diagram of the electrical stimulation device of other embodiments of the present invention.
Block schematic diagrams of Fig. 3 A for a kind of electrical stimulation device of the embodiment of the present invention.
Fig. 3 B are the circuit diagram of the amplifier of electrical stimulation device of the present invention.
Fig. 3 C are the waveform diagram of the frequency signal produced by electrical stimulation device of the present invention.
Fig. 4 A are the block schematic diagram of another kind electrical stimulation device of the invention.
Schematic diagrams of Fig. 4 B for wave filter shown in Fig. 4 A.
Fig. 5 A are the block schematic diagram of another embodiment of electrical stimulation device of the present invention.
Circuit diagrams of Fig. 5 B for the differential amplifier of the electrical stimulation device of Fig. 5 A.
Circuit diagrams of Fig. 5 C for the amplifier of the electrical stimulation device of Fig. 5 A.
Fig. 6 A to Fig. 6 D are the oscillogram of the preferred embodiment of Bipolar pulse wave signal.
Oscillograms of the Fig. 7 for one embodiment of electrical stimulation signal.
Fig. 8 A to Fig. 8 D are the waveform diagram in electrical stimulation signal difference embodiment of the present invention.
Specific embodiment
Hereinafter with reference to relevant drawings, a kind of electrical stimulation device according to the preferred embodiment of the present invention is illustrated, wherein Identical component will be illustrated with identical reference marks.
To make the framework of this device be more fully apparent from the correlative detail of other adapting devices when implementing, with The lower structure configuration first introduced when electrical stimulation device carries out electricity irritation for the purpose region of organism, and and its The circuit structure of the controller of cooperation and the mode for cooperating.
As shown in Figure 1A, electrical stimulation device 1 may be disposed at outside individual, or at least partly implantation is in vivo Portion is to carry out electronic stimulation, and electrical stimulation device 1 is preferably nerve stimulation device, e.g. vertebra Dorsal root Neuroganglion electrical stimulation device, so when practical application, stimulated purpose region such as but not limited to can be applied Brain, vertebra and/or cornu dorsale medullae spinalises (Spinal dorsal horn) in electricity irritation organism, spinal epidural cavity (epidural space).Wherein, above-mentioned vertebra refer in particular to Psychotria rubra (Lour.) Poir. thoracic vertebra nerve (T9 vertebrae) and Protelum thoracic vertebra nerve (T10 vertebrae).Herein referred individuality is organism, and which mainly includes suckling Class animal, such as mouse, the mankind, rabbit, cattle, sheep, pig, monkey, Canis familiaris L., cat etc., the preferably mankind.Electricity thorn Excitation device 1 includes control unit 11 and electrical stimulation unit 12, is with the electricity of electrical stimulation device 1 in Figure 1A Stimulating unit 12 is illustrated as a example by being at least partly implanted into the mankind, and the electrode (first of electrical stimulation unit 12 Electrode E1, second electrode E2) it is implanted in by vertebra dorsal root ganglion 3, to carry out electricity irritation.
Figure 1B is the circuit box schematic diagram of the controller 2 of electrical stimulation device 1 and its collocation.Refer to Figure 1B Shown, electrical stimulation device 1 enters the setting of line parameter and the supply of energy through controller 2, due to controller 2 And need not be implanted in organism, therefore also referred to as peripheral control unit (External Controller).Hereinafter first divide The mutual pass of electrical stimulation device 1 and controller 2 is not illustrated.
Electrical stimulation device 1 includes control unit 11 and electrical stimulation unit 12.Electrical stimulation unit 12 is coupled to Control unit 11;Controller 2 then includes that the supply of another control unit 21, man-machine interface 22 and power supply is single Unit 23, wherein, the coupling control unit 21 of man-machine interface 22, and 23 same coupling control of power-supply unit Unit 21 power source as controller 2.Power-supply unit 23 can be battery or rechargeable battery, Or can be power supply adaptor, electric power is provided to connect the civil power of outside.
During operation, user can pass through the man-machine interface 22 of controller 2, first by controller 2 before starting Default value is initialized, and the parameter of required setting is input to control followed by by man-machine interface 22 Unit 21.Wherein, man-machine interface 22 may be, for example, touch controlled key on portable electronic devices, contact panel, Physical button or combinations thereof, are not any limitation as in this.Control unit 21 then indicates power-supply unit 23 Supply direct current power is operated to each component (particularly electrical stimulation unit 12) of electrical stimulation device 1.Its In, control unit 11 and control unit 21 all can be by digital circuits such as integrated circuit (IC), or simulation electricity Road realizing, wherein integrated circuit may be, for example, microprocessor (Micro-processor), microcontroller (MCU), Can programmed logic gate array (FPGA or CPLD) or ASIC (ASIC), and this enforcement Example is illustrated by taking microcontroller (MCU) as an example, but the present invention is not intended to limit.
The thin portion structure explanation of electrical stimulation unit 12 is further directed to, be refer to shown in Figure 1A to Fig. 1 D, Electrical stimulation unit 12 includes having flexible wire (lead) L, its include at least one first electrode E1 and At least one second electrode E2, and the present embodiment includes one group of electrode, i.e. first electrode E1 for positive pole and the Two electrode E2 are explained for negative pole.Certainly, with regard to electrode number set on wire L, or two Group or more than three groups, and can be evenly distributed and be arranged on this wire L of electrical stimulation unit 12, or only lay In the end of wire L.And above-mentioned electrode is operated in biphasic mode (bi-phase mode), with Electric field is formed between first electrode E1 and second electrode E2, field regime covers purpose region and electric-field strength The scope of degree between 100V/m~5000V/m, to carry out electricity irritation to purpose region.In the present embodiment, The material of first electrode E1 and second electrode E2 is metal, for example, platinum, silver, gold or other have it is conductive The metal derby of property.It is actually between first electrode E1 and second electrode E2 same by what is be electrically connected with the electrodes Spindle guide line is wound in the region of coil (coils or wires), specifically, first electrode E1 and second electric Pole E2 is arranged at one end of wire L, and the other end of wire L then has two contacts as positive pole and negative pole, Two contacts are electrically connected with or electrical couplings with control unit 11.First electrode E1 and second electrode E2 respectively with The coil (wires) of winding links, and contact is linked to by coil, in addition, wire L is in first electrode E1 is provided with insulator I claddings with the coil outside second electrode E2.In Fig. 1 C, wire L is between electrode Subregion, remove insulator I, to illustrate the fine and close coil that is disposed therein.
And the scope of the individual lengths a of each electrode is arranged according to actually used demand, electrode length a between 0.5~6 millimeter, preferably 1~4 millimeter.Wherein, alleged first electrode E1 is individual with second electrode E2 Other length a refers to the length dimension on the major axis bearing of trend parallel to the wire L of electrical stimulation unit 12.First The distance between electrode E1 and second electrode E2 b between 1~7 millimeter, preferably 1~4 millimeter.
And with apart from c between first electrode E1 and second electrode E2 and dorsal root ganglion 3 of wire L, Definition apart from c is the midpoint between adjacent first electrode E1 and second electrode E2 and dorsal root ganglion 3 Beeline.In the present embodiment, the scope apart from c between 0~10 millimeter, wherein, when apart from c For 0 millimeter when, represent midpoint between first electrode E1 and second electrode E2 on the projecting direction with Dorsal root Neuroganglion 3 mutually coincides.
The electrical stimulation device 1 applied by above-described embodiment is active electrical stimulation device, its control unit 11 with Electrical stimulation unit 12 can be implanted into jointly to the purpose region of organism, and in other words, control unit 11 is pierced with electricity Sharp unit 12 is implanted in the subcutaneous position of organism, or control unit 11 and electrical stimulation unit 12 1 respectively After body formed, it is implanted in subcutaneous.The controller 2 outside organism is electrically coupled to through control unit 11, The parameter signal and electric energy from another control unit 21 can be received, so that electrical stimulation unit 12 can be directed to The purpose region of organism carries out electricity irritation.
So it should be noted that, electrical stimulation device form provided by the present invention is not with above-mentioned electrical stimulation device 1 It is limited, in other embodiments, active electric stimulator also is embodied as the electrical stimulation device form such as Fig. 2A. The electrical stimulation device 1a of the present embodiment has substantially the same group with the electrical stimulation device 1 of previous embodiment Part, and control unit 11a and electrical stimulation unit 12a are implanted in the position of (subcutaneous) within living thing's skins S Put.But control unit 11a of the electrical stimulation device 1a of the present embodiment is integrated on flexible circuit board (F), and The parameter signal and electric energy of another control unit (not shown) outside organism can be equally received, from And make the wire La of electrical stimulation unit 12a carry out electricity irritation for the underlying nerve 3a of organism.This reality The electrical stimulation device 1a for applying example can reduce the volume being implanted into subcutaneous device, to reduce organism (patient) Burden.
Or, the electrical stimulation device of the present invention also can select the form such as Fig. 2 B.As shown in Figure 2 B, this reality The electrical stimulation device 1b for applying example is passive type electrical stimulation device, and its electrical stimulation device 1 with previous embodiment is not It is that control unit 11b of electrical stimulation device 1b is integrated in and is arranged on outside living thing's skins S with where The controller 2b of (outside skin), therefore the electrical stimulation device 1b of implantation does not have control unit.And electricity irritation list The afterbody of unit (lead) 11b has flexible circuit board and positioned at depth not deep subcutaneous (such as depth is less than 5cm), Wire L2 is given to pass through the peripheral control unit 2b for not being implanted in Intradermal transmission electrical stimulation signals, so that electricity irritation Unit 12b can be directed to the underlying nerve 3a of organism and carry out the electricity irritation of passivity.
Then, refer to shown in Fig. 3 A, which is the block schematic diagram of preferred embodiment of the present invention electrical stimulation device. Electrical stimulation device 1 includes control unit 11 and electrical stimulation unit 12.Control unit 11 can store electric thorn Sharp parameter and electricity irritation data, and according to these parameters and 12 start of Data Control electrical stimulation unit.Electricity irritation Unit 12 includes pulse generator 120, frequency synthesizer 121, amplifier 122 and variable resistance 123.Electricity Stimulating unit 12 can reception control unit 11 instruction and export electrical stimulation signal S1 to individuality to carry out electric thorn Swash treatment, the wherein voltage of electrical stimulation signal S1 is Bipolar, to reduce harm of the electronic stimulation to nerve, And its absolute value is between 3V to 12V, e.g. alternating current of the amplitude for 3V to 12V.Furthermore, it is understood that Frequency synthesizer 121 couples control unit 11, and produces frequency signal according to the control of control unit 11 S2, its frequency are greater than 100kHz, and the present embodiment is with frequency synthesizer 121 as direct digital synthesiser Illustrate as a example by (Direct Digital Synthesizer).For example, direct digital synthesiser can select The AD9833 of Ya De promise semiconductor company (Analog Device, Inc.), its exportable string ripple, square wave or three Angle ripple, maximum output frequency are 12.5MHz, and the frequency of output voltage about 650mV, i.e. the present embodiment letter The voltage of number S2 is 650mV.Certainly, the model for limiting frequency synthesizer 121 of the invention is why, As long as high-frequency frequency signal S2 can be produced by frequency synthesizer 121, and high-frequency electricity is exported according to this Stimulus signal S1.However, in another embodiment, frequency synthesizer 121 also independently can be integrated in (do not illustrate) in control unit 11, that is, now electrical stimulation unit 12 only include pulse generator 120, Amplifier 122 and variable resistance 123.
Note that the electrical stimulation device of the present invention can be with current/voltage drive, for convenience of description, following Paragraph in, form of implementation is driven to voltage all and is illustrated, but in identical circuit framework, put Voltage signal also can be transformed into current signal and make electrical stimulation device of the present invention be changed to electric current driving by big device 122, The present invention is not limited.
Referring to shown in Fig. 3 B, which is the circuit diagram of amplifier.In the present embodiment, amplifier 122 Frequency synthesizer 121 is coupled to, amplifier 122 is operational amplifier (Operational Amplifier, OPA), Which has reverse input end In1, non-inverting input In2 and outfan Out.Frequency synthesizer 121 is coupled One of input (reverse input end In1 or non-inverting input In2) of amplifier 122, wherein this reality It is to couple reverse input end In1 with frequency synthesizer 121 to apply example, and is entered as a example by non-inverting input In12 ground connection Row explanation.Consequently, it is possible to due to the output voltage of frequency synthesizer 121 relatively low (about 650mV), therefore The voltage amplification of the frequency signal S2 that frequency synthesizer 121 is exported by amplifier 122 by the present embodiment is to 3V To 12V, set with the voltage for meeting above-mentioned electrical stimulation signal S1.
Variable resistance 123 can be digital regulation resistance (digital potentiometer, digiPOT), with electricity Resistance, and couple control unit 11 and amplifier 122.For example, variable resistance 123 is to select Ya De The digital variable resistance of the AD5290 of promise semiconductor company, 10k Ω.Control unit 11 will be joined according to electricity irritation The resistance value of number adjustment variable resistance 123, thus resistance value is not fixed value.Consequently, it is possible to amplify Frequency signal S2 according to frequency synthesizer 121 is pierced by device 122 with the resistance value output electricity of variable resistance 123 Depending on the frequency of energizing signal S1, wherein electrical stimulation signal S1 is the frequency signal S2 by frequency synthesizer 121, E.g. it is more than 100kHz, for example, 200kHz to 1000kHz, and the voltage of electrical stimulation signal S1 is then Depending on amount of gain by amplifier 122, the wherein increasing of the resistance value influences amplifier 122 of variable resistance 123 Benefit.It is noted that frequency signal S2 be preferably between 200kHz~250kHz, 250kHz~350kHz, 350kHz~450kHz, 450kHz~550kHz, 550kHz~650kHz, 650kHz~750kHz, 750kHz~800kHz or 800kHz~1000kHz.Wherein, when select frequency range between 200KHz~ During 450KHz, can operate in relatively low frequency, therefore the risk of produced biological heat is low, with safer excellent Gesture;Conversely, when the frequency range that select is between 550kHz~1000kHz, then the electric field density for being formed compared with Greatly, its electrical stimulating effect is preferable.
Furthermore, in the present embodiment, one end coupling amplifier 122 of variable resistance 123 is reverse Input In1, and the other end couple amplifier 122 outfan Out, that is, variable resistance 123 with put Big device 122 forms negative feedback configuration.The amount of gain of amplifier 122 is the resistance value according to variable resistance 123 Change and adjust, and control unit 11 then according to parameters of electrical stimulation or setting adjustment variable resistance 123 electricity Resistance, and then change the gain of amplifier 122, so that the voltage of electrical stimulation signal S1 can be between the electricity of setting In the range of pressure.
Referring to shown in Fig. 3 C, which is the waveform diagram of frequency signal.In the present embodiment, frequency Signal S2 is that continuous square wave is sent in intermittent mode, that is, is often just sent out through a Pulse period TP Go out the square-wave signal of high frequency TD (hereinafter referred to as pulse wave ripple width TD) for a period of time.In note that Fig. 3 C The frequency of high-frequency square-wave signal is only illustrated, and actual situation frequency should be higher.The square-wave signal of high frequency Pulse wave frequency between 0 to 1KHz, in a preferred embodiment, the arteries and veins of the square-wave signal of high frequency Wave frequency can be between 1 to 100Hz.In the present embodiment, the pulse wave frequency of the square-wave signal of high frequency It is then 2Hz.Additionally, pulse wave ripple width TD (persistent period) is between 1 to 250ms.At one preferably Embodiment in, the wide TD of pulse wave ripple can be between 10 to 100ms.In the present embodiment, pulse wave ripple Wide TD is 25ms.
Note that for the impression that patient should not be allowed to cause discomfort because of unexpected electricity irritation, at another In embodiment, by taking the electrical stimulation device that voltage drives as an example, when treatment starts, by medical personnel or user After opening the power supply of electrical stimulation device, medical personnel or user can be with manual knobs, or electrical stimulation device The mode for itself voluntarily controlling, makes the voltage of electrical stimulation signal S1 when producing at the beginning, from 0V The slow magnitude of voltage (absolute value of target voltage ranges can be between 3V to 12V) for rising to target, and can control Electrical stimulation signal S1 voltages processed are less than 1V enhanced speed each second.If the electricity irritation dress driven with electric current Example is set to, then, when treatment starts, electric current can be increased to current value (the target electricity of target at leisure by 0mA The absolute value of stream scope can be between 0.5uA to 50mA), and the increasing of electrical stimulation signal S1 electric currents can be controlled Strong speed is less than 5mA (preferably per second less than 1mA) each second.After treatment end, it is intended to close When closing electrical stimulation signal S1, then the slow drop step of relative curtage need not be carried out (by electric current or electricity The absolute value of pressure slowly diminishes).In a preferred embodiment, the current value of target is 25mA.
Referring to shown in Fig. 4 A and Fig. 4 B, wherein Fig. 4 A are another kind electrical stimulation device of the invention Block schematic diagram, and Fig. 4 B are the schematic diagram of wave filter shown in Fig. 4 A.In the present embodiment, electricity irritation Unit 12a further includes wave filter 124a, and between frequency synthesizer 121 and amplifier 122, i.e., which be coupled to Wave filter 124a couples reverse input end In1.The wave filter 124a of the present embodiment is low pass filter, is ended Frequency (cut off frequency) is 1000kHz, with the HFS of rejection frequency signal S2, makes input Signal to amplifier 122 is below 1000kHz, to meet the default frequency scope of electrical stimulation signal S1 (100kHz to 1000kHz).And as shown in Figure 4 B, wave filter 124a can pass through another amplifier A couplings Electric capacity C is met with electrical complex R to realize, is by taking second-order low-pass filter as an example, but not to limit in this The fixed present invention.
Refer again to Fig. 3 A, it is worth mentioning at this point that, the power source of electrical stimulation device 1 is alternatively built-in electricity Pond, its coupling Power Management Unit (not shown), and Power Management Unit can provide the electric power of battery to control Unit processed 11 and electrical stimulation unit 12.Or, power source can be outside power-supply unit, for example, Wireless charging unit, which has coil and commutator, couples the magnetic that a wireless power supply is produced by coil , and then faradic current is produced, and faradic current rectification is exported to electricity irritation again by commutator for DC current The Power Management Unit of device 1, to supply to control unit 11 and electrical stimulation unit 12.Additionally, power supply pipe Reason unit may include voltage reversal device (voltage invertor), its can by the pole reversal of the voltage for receiving, To provide the working inverse voltage needed for amplifier 122.
Fig. 4 A are refer to again, and electrical stimulation unit 12a can further include detector 125, and which is coupled to control unit 11 and amplifier 122, and detect electrical stimulation signal S1.In the present embodiment, detector 125 is coupled to put The outfan Out of big device 122, and control unit 11 can measure electrical stimulation signal S1's according to detector 125 Whether voltage, the waveform for e.g. comparing outfan Out meet default waveform (such as aforementioned 3V to 12V), When the waveform of electrical stimulation signal S1 deviates, control unit 11 can correct parameters of electrical stimulation in real time, e.g. Change the resistance value of variable resistance 123, so that electrical stimulation signal S1 meets aforesaid voltage scope, and then avoid The electrical stimulation signal S1 of output error voltage.
In addition, in certain embodiments, electrical stimulation unit 12a can further include surge protecter (surge Protection) 126, its coupling amplifier 122 is for example coupled to the outfan Out of amplifier 122.It is prominent Ripple protector 126 may be, for example, Zener diode, transient voltage suppressing (transient voltages suppression, TVS) diode or bi-directional electrostatic protection diode (bidirectional ESD protection diodes) etc.. As International Organization for Standardization specifies to be implanted in the active implantation of individuality in international standard number ISO14708-3 Medical treatment device (active implantable medical devices, AIMD) can not be made in individual (such as sufferer) With except tremble device (defibrillation) when, produce permanent impact, therefore, surge protecter 126 is set The acceptable low pressure of human body (such as 5V) can will be clamped to except high pressure (such as the 1000V) pulse of device offer of trembling, To prevent individuality because high-voltage pulse causes nerve damage, electrical stimulation unit 12a can be also avoided to export in exception The electrical stimulation signal S1 of too high voltages, and individuality is caused to damage.
Additionally, in other embodiments, one end of variable resistance 123 can only couple input, and the other end Receives frequency signal S2, thus control unit 11 can pass through to change the resistance value of variable resistance 123, with partial pressure Mode change the voltage of frequency signal S2, and then change the electrical stimulation signal S1 of the output of amplifier 122 Voltage.
In addition, in certain embodiments, one end of variable resistance 123 can only couple outfan Out, and another End ground connection, such control unit 11 can equally pass through the resistance value for changing variable resistance 123, with the side of partial pressure Formula changes the voltage of electrical stimulation signal S1.
In general, the neuron of central nervous system (central nervous system) is mainly comprising sensation Two kinds of neuron (sensory neuron) and motor neuron (motor neuron), wherein high-frequency electrical are pierced Energizing signal can't produce stimulation to sensory neuron or motor neuron, that is to say, that human body is not feel Feel, therefore for patient, when using high-frequency electrical stimulation signal to be treated, it may occur that Patient is not because feel electricity irritation, and thinks not in the psychological application treated.In order to solve this Individual problem, over the course for the treatment of, can add the electrical stimulation signal of some low frequencies to produce patient for treatment's process It is raw to feel, and then can more securely receive treatment.In addition, the electrical stimulation signal by low frequency, moreover it is possible to planting Enter the positioning of feedback healthcare givers electrode or device during electrical stimulation device, in order to avoid after implantation, just discovery Electrical stimulation device position offsets.
Then, referring to Fig. 5 A to Fig. 5 C, Fig. 5 A are another embodiment of electrical stimulation device of the present invention Block schematic diagram, circuit diagrams of Fig. 5 B for the differential amplifier of the electrical stimulation device of Fig. 5 A, Fig. 5 C are The circuit diagram of the amplifier of the electrical stimulation device of Fig. 5 A.The structure composition of electrical stimulation device 1b is filled with electricity irritation The structure composition for putting 1a is roughly the same, and difference is that the electrical stimulation unit 12b of electrical stimulation device 1b is another Including pulse generator 120 and differential amplifier 124 (differential amplifier), and electrical stimulation device The amplifier 122b of 1b is summing amplifier (summing amplifier).Pulse generator 120 is produced respectively One group of pulse wave signal, just can produce Bipolar pulse wave signal S3 after differential amplifier 124 after addition.It is double Phasic property pulse wave signal S3 is essentially a kind of low frequency signal, therefore adds electrical stimulation signal through amplifier 122b After S1, patient can be made to electricity irritation sensigenouses (sensory neuron) or muscle contraction (motion is caused Neuron), and positive signal section needs to reach electric charge with negative signal section in Bipolar pulse wave signal S3 Balance (charge balance) could reduce electronic stimulation to the harm caused by nerve.In the present invention, Charge balance is defined as that " positive signal section is to the integrated value obtained by time integral and negative signal section pair Obtained by the absolute value of the integrated value sum obtained by time integral is not more than positive signal section to time integral Integrated value 1/10th ".
Furtherly, Fig. 5 A and Fig. 5 B are please also refer to, Fig. 5 B are the differential of electrical stimulation device of the present invention The circuit diagram of one preferred embodiment of amplifier 124.Differential amplifier 124 is operational amplifier (Operational Amplifier, OPA), which has reverse input end In1, non-inverting input In2 and defeated Go out to hold Out.Pulse generator 120 produces the first pulse wave signal SP1 and at least one second pulse wave signals SP2_1 to SP2_4.In the present embodiment, the first pulse wave signal SP1 of pulse generator 120 passes through resistance R1 couples the non-inverting input In2 of differential amplifier 124, and the non-return input of differential amplifier 124 End In2 is coupled to ground through resistance R2.The outfan of differential amplifier 124 and non-inverting input In2 it Between coupling resistance R3.Second pulse wave signal SP2_1 to SP2_4 of pulse generator 120 passes through resistance respectively R4 to R7 couples the reverse input end In1 of differential amplifier 124.Consequently, it is possible to Bipolar pulse wave signal S3 just can pass through following equation calculating and learn:
S3=SP1 (R2/ (R1+R2)) (R3/ (R4//R5//R6//R7))
+SP2_1(-R3/R4)+SP2_2(-R3/R5)+SP2_3(-R3/R6)+SP2_4(-R3/R7)
In the present embodiment, R1=R2=R3, R4=R5=8*R1, R6=4*R1, R7=2*R1.Therefore above formula It is changed into:
S3=SP1+SP2_1 (- 1/8)+SP2_2 (- 1/8)+SP2_3 (- 2/8)+SP2_3 (- 4/8)
Understand that by above formula the positive signal section of Bipolar pulse wave signal S3 is made up of the first pulse wave signal SP1, Negative signal section is made up of the second pulse wave signal SP2_1 to SP2_4.Consequently, it is possible to electricity irritation of the present invention Device just can pass through the second pulse wave signal SP2_1 to SP2_4 of control to adjust the waveform of negative signal section.
For example, Fig. 6 A to Fig. 6 D are refer to, Fig. 6 A to Fig. 6 D are the preferred of Bipolar pulse wave signal The oscillogram of embodiment.In fig. 6, the first pulse wave signal SP1 has amplitude A p and ripple width Tp;Second Pulse wave signal SP2_1 to SP2_4 has amplitude A n and ripple width Tn.In the present embodiment, amplitude A p etc. In amplitude A n, and between 3V to 12V, ripple width Tp is equal to ripple width Tn, and between 50 μ s to 100 Between μ s.Consequently, it is possible to the second pulse wave signal SP2_1 can become anti-phase after differential amplifier 124, And amplitude is changed into 1/8Ap.Second pulse wave signal SP2_2 can become anti-phase after differential amplifier 124, And amplitude is changed into 1/8Ap.Second pulse wave signal SP2_3 can become anti-phase after differential amplifier 124, And amplitude is changed into 1/4Ap.Second pulse wave signal SP2_4 can become anti-phase after differential amplifier 124, And amplitude is changed into 1/2Ap.Second pulse wave signal SP2_1 to SP_4 after 124 addition of differential amplifier, Amplitude can just be equal to Ap, and become anti-phase with the first pulse wave signal SP1.
In fig. 6b, in fig. 6b, the first pulse wave signal SP1 has amplitude A p and ripple width Tp;Second Pulse wave signal SP2_1 to SP2_3 has amplitude A n and ripple width Tn.In the present embodiment, in order to reach electricity Lotus balances, and amplitude A p is equal to amplitude A n, and between 3V to 12V, ripples of the wide Tn of ripple equal to 2 times Wide Tp, and between 50us to 100us.Consequently, it is possible to the second pulse wave signal SP2_1 is put through differential Can become anti-phase after big device 124, and amplitude is changed into 1/8Ap.Second pulse wave signal SP2_2 is put through differential Can become anti-phase after big device 124, and amplitude is changed into 1/8Ap.Second pulse wave signal SP2_3 is put through differential Can become anti-phase after big device 124, and amplitude is changed into 1/4Ap.Second pulse wave signal SP2_1 to SP_4 Jing After crossing 124 addition of differential amplifier, amplitude just can be equal to 1/2Ap, and with the first pulse wave signal SP1 Become anti-phase.Due to ripple width Tps of the wide Tn of ripple equal to 2 times, therefore still meet the requirement of charge balance.
In figure 6 c, in figure 6 c, the first pulse wave signal SP1 has amplitude A p and ripple width Tp;Second Pulse wave signal SP2_1 to SP2_4 has amplitude A n and ripple width Tn.In the present embodiment, amplitude A p etc. In amplitude A n, ripple width Tp is equal to ripple width Tn, and the first pulse wave signal SP1 and the second pulse wave signal SP2_1 To between SP2_4 have time difference Td.Consequently, it is possible to the second pulse wave signal SP2_1 is through differential amplification Can become anti-phase after device 124, and amplitude is changed into 1/8Ap.Second pulse wave signal SP2_2 is through differential amplification Can become anti-phase after device 124, and amplitude is changed into 1/8Ap.Second pulse wave signal SP2_3 is through differential amplification Can become anti-phase after device 124, and amplitude is changed into 1/4Ap.Second pulse wave signal SP2_4 is through differential amplification Can become anti-phase after device 124, and amplitude is changed into 1/2Ap.Second pulse wave signal SP2_1 to SP_4 is passed through After 124 addition of differential amplifier, amplitude can just be equal to Ap, and become anti-phase with the first pulse wave signal SP1.
Note that in another embodiment, also can in serial capacitance C (not illustrating) beside resistance R3, Negative signal section in Bipolar pulse wave signal S3 can be so allowed to produce decay (as shown in Figure 6 D), so that Bipolar pulse wave signal S3 is suitable for the patient of different body constitution.
Please continue to refer to Fig. 5 C, in the present embodiment, amplifier 122b is summing amplifier, is coupled to differential Amplifier 124, variable resistance 123 and frequency synthesizer 121.Amplifier 122b is operational amplifier (Operational Amplifier, OPA), which has reverse input end In1, non-inverting input In2 and defeated Go out to hold Out.One of input of the outfan coupling amplifier 122b of frequency synthesizer 121 is (reversely Input In1 or non-inverting input In2), the outfan of differential amplifier 124 is also coupled to amplifier 122b Same input, wherein the present embodiment be with frequency synthesizer 121 couple reverse input end In1, rather than Illustrate as a example by reverse input end In12 ground connection.Consequently, it is possible to due to the output electricity of frequency synthesizer 121 Press relatively low (about 650mV), therefore the present embodiment passes through what frequency synthesizer 121 was exported by amplifier 122b The voltage amplification of frequency signal S2 is set to 3V to 12V with the voltage for meeting above-mentioned electrical stimulation signal S1. Frequency signal S2 and Bipolar pulse wave signal S3 (by taking Fig. 6 B as an example) are carried out addition by amplifier 122b Afterwards, electrical stimulation signal S1 is just obtained, its waveform is as shown in Figure 7.
Note that at least needs to keep more than 2 μ s between Bipolar pulse wave signal S3 and frequency signal S2 The time difference.Additionally, in design variation, such as, when electronic stimulation is carried out, Bipolar pulse wave signal S3 can Be designed as before the course for the treatment of and or the course for the treatment of after send at least one times, with point out patient procedure beginning and or terminate. In another design variation, such as when electrical stimulation device is implanted into, Bipolar pulse wave signal S3 also may be used It is designed as intermittent cyclical signal, for example, pulse generator 120 is controllable to produce pulse wave signal SP1, SP2_1 to SP2_4 cause differential amplifier interval in 4 Pulse period TP of frequency signal S2 Property ground produce 4 Bipolar pulse wave signal S3, each Bipolar pulse wave signal S3 duration T m, and 2 μ s are spaced at least, consequently, it is possible to frequency signal S2 and Bipolar pulse wave signal S3 passes through amplifier 122b The electrical stimulation signal S1 of synthesis just can as shown in Figure 8 A to 8 D, and Fig. 8 A to Fig. 8 D are present invention electricity thorn Waveform diagram in energizing signal difference embodiment.Note that Fig. 8 A to Fig. 8 D only examples to illustrate The possible waveform of the electrical stimulation signal S1 by synthesized by frequency signal S2 is with Bipolar pulse wave signal S3, electricity The waveform of stimulus signal S1 can also have other versions, as long as pulse generator 120 controls Bipolar arteries and veins The frequency that ripple signal S3 occurs is not more than the pulse wave frequency of frequency signal S2, the electrical stimulation signal for finally producing The waveform of S1 all should belong to the category of the present invention.
In sum, electrical stimulation device of the invention adjusts the frequency of output signal by frequency synthesizer, with And the voltage range of output signal is adjusted by amplifier and variable resistance so that first electrode and second electrode Produce electric field of the electric field intensity between 100V/m~5000V/m.Consequently, it is possible to electrical stimulation device can be in response to Different application modes provides the electrical stimulation signal of different electric field intensity and gives patient appropriate electronic stimulation. On the other hand, electrical stimulation device of the invention by pulse generator and differential amplifier by powered total amount phase Same pulse wave addition is amphicheirality's pulse wave of charge balance, is so just avoided that electrical stimulation signal is caused to nerve Harm.
More than the being only for example property, rather than be restricted person.Any spirit and scope without departing from the present invention, And equivalent modifications which is carried out or change, it is intended to be limited solely by appended claims.

Claims (16)

1. a kind of electrical stimulation device, is applied to the purpose region of electricity irritation organism, and the device includes:
Control unit;And
Electrical stimulation unit, including:
Frequency synthesizer, couples the control unit, and produces frequency signal;
Amplifier, couples the frequency synthesizer;
Variable resistance, with resistance value, and couples the control unit and the amplifier;And
At least one first electrode and at least one second electrode, couple the amplifier,
Wherein, frequency signal and the variable-resistance resistance value according to the frequency synthesizer of the amplifier Output electrical stimulation signal, makes the first electrode produce electric field with the second electrode, and the field regime covers the mesh Region and the electric field intensity scope between 100V/m~5000V/m, to carry out electric thorn to the purpose region Swash.
2. electrical stimulation device according to claim 1, the wherein frequency synthesizer couple the amplifier Input.
3. what electrical stimulation device according to claim 2, the wherein variable resistance coupled the amplifier should Input.
4. the electrical stimulation device according to Claims 2 or 3, the wherein variable resistance couple the amplifier Outfan.
5. electrical stimulation device according to claim 1, the wherein electrical stimulation unit further include wave filter, It is coupled between the frequency synthesizer and the amplifier.
6. electrical stimulation device according to claim 1, the wherein electrical stimulation unit further include detector, The control unit and the amplifier are coupled, and detects the electrical stimulation signal.
7. electrical stimulation device according to claim 1, the wherein electrical stimulation unit further include surging protection Device, which couples the amplifier.
8. electrical stimulation device according to claim 1, the wherein electrical stimulation device are implantation type electric stimulation Device.
9. electrical stimulation device according to claim 1, the wherein frequency of the electrical stimulation signal between Between 200kHz to 1000kHz.
10. electrical stimulation device according to claim 1, the wherein voltage of the electrical stimulation signal are bipolar Property, and its absolute value is between 3V to 12V.
11. electrical stimulation devices according to claim 1, the wherein amplifier are summing amplifier, and should Electrical stimulation device is further included:
Pulse generator, couples the control unit, produces multiple pulse wave signals;And
Differential amplifier, couples the pulse generator and the amplifier, double according to the output of the plurality of pulse wave signal Phasic property pulse wave signal,
Wherein, the amplifier is according to the Bipolar pulse wave signal, the frequency signal and the variable-resistance electricity Resistance exports the electrical stimulation signal.
12. electrical stimulation devices according to claim 11, the wherein Bipolar pulse wave signal just have one Phase signals part and a negative signal section, and the positive signal section to the integrated value of time integral with should Negative signal section is not more than the positive signal section to the time to the absolute value of the integrated value sum of time integral / 10th of the integrated value of integration.
A kind of 13. electrical stimulation methods for embedded type device, with the purpose region of electricity irritation organism, the plant Enter formula device and include frequency synthesizer, variable resistance and at least one first electrode and at least one second Electrode, the electrical stimulation method are included:
Frequency signal is produced using the frequency synthesizer;
According to the frequency signal and the variable-resistance resistance value output electricity irritation letter of the frequency synthesizer Number;And
The electrical stimulation signal is exported using at least one first electrode and at least one second electrode so that The first electrode produces electric field with the second electrode, and the field regime covers the purpose region and the electric field intensity Scope between 100V/m~5000V/m, to carry out electricity irritation to the purpose region.
14. electrical stimulation methods according to claim 13, the wherein frequency of the electrical stimulation signal between Between 200kHz to 1000kHz.
15. electrical stimulation methods according to claim 13, further include:
Produce multiple pulse wave signals;And
Bipolar pulse wave signal is exported according to the plurality of pulse wave signal;
The electrical stimulation signal is exported according to the Bipolar pulse wave signal, the frequency signal.
16. electrical stimulation methods according to claim 13, the Bipolar pulse wave signal have positive phase signals Part and negative signal section, and integrated value and the negative signal of the positive signal section to time integral Part is not more than the product of the positive signal section to time integral to the absolute value of the integrated value sum of time integral / 10th of score value.
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