CN105492066B - For stimulating diathermic method and apparatus - Google Patents

For stimulating diathermic method and apparatus Download PDF

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Publication number
CN105492066B
CN105492066B CN201380077466.5A CN201380077466A CN105492066B CN 105492066 B CN105492066 B CN 105492066B CN 201380077466 A CN201380077466 A CN 201380077466A CN 105492066 B CN105492066 B CN 105492066B
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China
Prior art keywords
signal
patient
autonomic nerves
conductive electrode
electric device
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CN201380077466.5A
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CN105492066A (en
Inventor
史里尼·纳格希沃
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Dyansys Inc
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Dyansys Inc
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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
    • A61N1/36014External stimulators, e.g. with patch electrodes
    • A61N1/36017External stimulators, e.g. with patch electrodes with leads or electrodes penetrating the skin

Abstract

The present invention relates to a kind of electric device, and it includes battery, circuit and rf receiver and transmitter suitable for generating cyclical signal.The electric device also includes the control circuit for being suitable to set the characteristic of cyclical signal.The characteristic is received by the input of rf receiver and transmitter.The electric device also includes the first conductive electrode suitable for electrical contact, and the Part I on the surface is pierced through when cyclical signal is injected below the Part I on surface.The cyclical signal is coupled to the first conductive electrode.

Description

For stimulating diathermic method and apparatus
The cross reference of related application
The application is related to entitled " the extracting causal information authorized on the 15th of August in 2006 From a chaotic time series (from chaos time sequence extraction cause and effect information) " U.S. Patent number 7092849, should The full content of patent is incorporated herein by reference.The application also relates to the following of submission while the application of submission:It is entitled " stimulative electrotherapy using autonomic nervous system control (use autonomous god Through system control stimulation diathermy) " US patent application attorney Docket Number 89562-000300US-874038, topic For " method and apparatus for autonomic nervous system sensitivity-point Testing (method and apparatus of autonomic nerves system sensitive spot test) " US patent application attorney's Docket Number 89562-000400US-874044 and entitled " computer implemented training a procedure (calculating Machine implement procedural training) " US patent application attorney's Docket Number 89562-000500US-874022, above-mentioned patent The full content of application is incorporated herein by reference.
Technical field
The invention mainly relates to the method and apparatus for applying electric signal to patient, specifically, for the nerveous system of patient The method and apparatus of system application time variable signal.
Background technology
HRV measurement is had been found to assess the strong mode of influence of the autonomic nerves system to cardiac system. In fact, autonomic nerves system is propped up together with its sympathetic nerve and parasympathetic nerve (also referred to as " vagus nerve " subsystem below) Involuntary action with the myocardium and each internal organs in body.
Autonomic nerves system can not directly touch active control.But based on autonomic reflex and center control with from master mode Operating.One of its major function is to maintain internal homeostasis.Autonomic nerves system is in organism and its surrounding environment Further play the part of adaptive role in interaction.
In many diseases, the sympathetic and/or parasympathetic part of autonomic nerves system is impacted to cause autonomic dysfunction.In It is with the reliable of state and just critically important for representational measurement with the activity on autonomic nerves system.
The United States Patent (USP) No.7,092,849 for authorizing Lafitte et al. is described for analyzing autonomic nerve from time varying signal Method, system and the computer code of the state of system, wherein time varying signal represent the heart system dominated by autonomic nerves system The time interval of chaos sequence between paracycle event caused by system.Therefore, the parasympathetic nerve portion of autonomic nerves system The real-time monitoring of the sympathovagal balance divided between sympathetic division is possible.
Autonomic nerves system plays the part of important role in pain is adjusted and is perceived, and chronic ache is probably because body Dysfunction in interior central nervous system.Although having many medicines and physical therapy to be used to treat pain, they are not Pain can be cured and only mask pain is reacted, (such as anaesthetic treatment) is also with undesirable side effect sometimes.
Point stimulator tool is for treating the permanent acupuncture with time chronic ache similar to the non-narcotic of pin and electro photoluminescence Property combination.Electro photoluminescence apparatus is based on by stimulating the point on ear to make the dysfunction normalization of body to make using ear acupuncture therapy For treatment.It is believed that the improvement of resulting pain and disease passes through sympathetic nerve and the network structure of parasympathetic.Ear Specified point in piece is related to the major organs in body.However, the point for being currently used for detecting and positioning on skin surface stimulates The medical treatment device and therapeutic scheme of the sensitive spot of pin insertion can't use the function of monitoring sympathetic vagus nerve balance in real time.It is existing Some Punctual stimulation devices only provide fixed electrical stimulation signal
The content of the invention
According to one embodiment of present invention, electric device includes the battery, circuit suitable for generating cyclical signal, wireless RF transceiver.The electric device also includes the control circuit for being suitable to set the characteristic of cyclical signal.The characteristic passes through The input of rf receiver and transmitter receives.The electric device also includes the first conductive electrode, and first conductive electrode is fitted The Part I on the surface is pierced through when making electrical contact with and below the Part I on cyclical signal injection surface.Periodically believe Number it is coupled to first conductive electrode.
According to one embodiment, electric device also includes the second conductive electrode, and second conductive electrode is suitable to electrical contact But the Part II on surface is not pierced through.Second conductive electrode provides direct between the second conductive electrode and the Part II on surface Electrical contact, when cyclical signal is injected below the Part I on surface, second conductive electrode provides cyclical signal Return signal path.
According to one embodiment, electric device is also included with insulating surface and at least the first hole in insulating surface Shell.First conductive electrode is suitable to be positioned in enclosure and be coupled to the circuit by the first hole.The shell enclosure Battery and circuit.
According to one embodiment, the shell is fitted when being suitable to below the Part I on cyclical signal injection surface In the shape for the Part III for meeting surface.According to one embodiment, the shell is suitable to the gas-tight seal electric device.
According to one embodiment, rf receiver and transmitter with selected from Transmission standard work.According to one embodiment, the characteristic choosing One kind from frequency, amplitude, pulse shape or dutycycle.
According to one embodiment, cyclical signal is electrotherapy signal.The characteristic of cyclical signal is suitable to the pair for stimulating patient The reaction of stomodaeal nervous system.When below the Part I on cyclical signal injection surface, the surface is the skin of patient. According to one embodiment, the set of frequency of cyclical signal is the preset frequency associated with patient's treatment.
According to one embodiment of present invention, signal injection method include provide battery, provide rf receiver and transmitter, First conductive electrode is provided.This method also includes generating cyclical signal in good time by circuit, passes through the input of wireless transceiver The characteristic of cyclical signal is received, and the characteristic is set via control circuit.Methods described is also included cyclical signal coupling It is bonded to the first conductive electrode, the Part I of electrical contact surface, and below the Part I on cyclical signal injection surface When pierce through the Part I on the surface.
According to one embodiment, methods described also includes the Part II of the second conductive electrode electrical contact surface but not pierced through The Part II on the surface.The direct electricity that second conductive electrode is provided between the second conductive electrode and the Part II on surface connects Touch, so as to which when cyclical signal is injected below the Part I on surface, second conductive electrode provides cyclical signal Return signal path.
According to one embodiment, methods described also includes providing at least first with insulating surface and in insulating surface The shell in hole, and the first conductive electrode is positioned at the enclosure.Methods described also includes leading first by the first hole Electrode is coupled to circuit, and with the body seal battery and circuit.
According to one embodiment, methods described also includes, and the shell is configured to when cyclical signal injection surface The shape of the Part III on surface is adapted to conform to when below Part I.According to one embodiment, it is outer that methods described also includes use The gas-tight seal electric device of shell.
According to one embodiment, methods described also includes a kind of choosing in frequency, amplitude, pulse shape or dutycycle Select the characteristic.According to one embodiment, it is to treat phase with patient that methods described, which is also included the set of frequency of cyclical signal, The preset frequency of association.
With reference to following embodiment and accompanying drawing, the essence and advantage of embodiments of the invention can be best understood from.
Brief description of the drawings
Fig. 1 shows the simplified block diagram of patient's test site according to an embodiment of the invention.
Fig. 2 shows the simplified block diagram and figure of autonomic nerves system sensitive spot tester according to an embodiment of the invention A part for patient skin shown in 1.
Fig. 3 shows the simplified block diagram of the autonomic nerves system stimulator shown in Fig. 2 according to an embodiment of the invention.
Fig. 4 A show that the autonomic nerves system according to an embodiment of the invention for being used to test on patient skin is sensitive The simplified flowchart of the method for point.
Fig. 4 B show that the autonomic nerves system for being used to test on patient skin according to another embodiment of the present invention is sensitive The simplified flowchart of the method for point.
Fig. 5 shows the exemplary reaction of the sympathetic vagus nerve balance used in method shown in Fig. 4 B.
Fig. 6 shows that patient according to an embodiment of the invention treats the simplified block diagram at scene.
Fig. 7 shows patient's skin shown in the simplified block diagram and Fig. 6 of electrotherapy stimulator according to an embodiment of the invention A part for skin.
Fig. 8 shows the letter for being used for the method that electrotherapy signal is injected into patient skin according to another embodiment of the present invention Change flow chart.
Fig. 9 shows statistical chart of the electrotherapy signal injection to the patient's reaction of electrotherapy signal frequency of peer review document.
Embodiment
The invention mainly relates to the method and apparatus for testing patient skin, more particularly to test patient skin to look for To the method and apparatus of autonomic nerves system sensitive spot.The treatment of ear acupuncture diathermy includes some on ear with reference to particular treatment Electrotherapeutic needle is inserted into the skin of patient at sensitive spot, and electrotherapy signal is put on into electrotherapeutic needle.Find the position for placing pin It can be determined by predicting general position and test or measuring local dermatopolyneuritis.However, diathermy treatment passes through parasympathetic system System works, therefore individually dermatopolyneuritis is not the optimal test indicator of electrotherapeutic needle arrangement.
According to one embodiment of present invention, the test and measurement for electrotherapeutic needle arrangement can be generated and believed using with electrotherapy Number similar or identical electric signal, the electric signal can use when treating a part for patient skin, without piercing through skin. Then applying medical diathermy signal detection skin surface via conductive tip, being stimulated with will pass through the sympathetic vagus nerve balance identification of monitoring The position of the vagus nerve reaction of the autonomic nerves system of patient.Then the position identified with electrotherapeutic needle thorn, then when long Between treat in period the electrotherapeutic needle be connected to electrotherapy signal.Initial alignment pin site can not form treatment, but can improve The diathermic result of acupuncture planned.
Fig. 1 shows the simplified block diagram of patient's test site 100 according to an embodiment of the invention.Patient's test site 100 include being coupled in the autonomic nerves system sensitive spot tester 110 of conductive tip 115 and electrode 120, the conductive tip 115 and electrode 120 be consecutively connected to ear 125, the ear 125 is hereinafter also referred to as " one of skin of patient 130 Point ".In one embodiment, autonomic nerves system monitor 135 is coupled respectively to positioned at patient's left arm, right arm, left leg, right leg On electrode 140,145,150,155, to receive the quasi- week for carrying out the cardiac system that dominates successively of free patient's autonomic nerves system Phase ECG signal.Patient preferably lies supine upon the testing stand for the clinical setting tested and monitored for autonomic nerves system.
In the exemplary embodiment shown in Fig. 1, it is people that patient, which represents,.It will be appreciated, however, that patient can be possessed certainly Any biology of main nervous system and cardiac system.In the exemplary embodiment shown in Fig. 1, shown autonomic nerves system is sensitive Point tester 110 is connected to ear.It will be appreciated, however, that autonomic nerves system sensitive spot tester 110 can replace being connected to skin Verified any position with the sensitive nerve connection to the autonomic nerves system for being enough to influence patient of skin.
In one embodiment, patient's test site 100 may include the graphic user interface 160 coupled to computer 165, Computer 165 can be coupled to autonomic nerves system tester 100 via cable (not shown) or via wireless radio frequency transmission 170. Preferably, autonomic nerves system sensitive spot tester is wireless handheld device, and it can be via graphic user interface 160 and computer 165 some characteristics to program or with being set by doctor or technician's (not shown).In one embodiment, computer 165 Can be desktop computer, notebook computer, tablet personal computer, mini tablet personal computer or the intelligence can with wireless transceiver 175 Mobile phone.
Autonomic nerves system monitor 135 is suitable to the parasympathetic that the ECG signal of patient is converted into autonomic nerves system The other information in sympathetic vagus nerve balance between neural part and sympathetic division.Authorize Lafitte et al. U.S. State patent No.7,092,849 and entitled " the STIMULATIVE ELECTROTHERAPY USING for authorizing Nageshwar AUTONOMIC NERVOUS SYSTEM CONTROL (the excitant diathermy controlled using autonomic nerves system) " it is common not United States Patent (USP) (above-mentioned patent is herein incorporated by reference) certainly is described partly in for autonomic nerves system monitor 135 Theory of operation.
Fig. 2 shows the simplified block diagram of autonomic nerves system sensitive spot tester 110 according to an embodiment of the invention With a part for the patient skin 125 shown in Fig. 1.Fig. 2 shows autonomic nerves system sensitive spot tester 110 (hereinafter Referred to as " circuit "), it include resistance test unit 210, indicator 215, autonomic nerves system stimulator 220, switch 230, lead Electric tip 115, battery 217, shell 223 and electrode 120.Electric resistance measuring apparatus 210 is coupled to indicator 215.Battery 217 is to electricity Road provides compact power and allows hand-held.
Electric resistance measuring apparatus 210 is suitable to generation resistance measuring signals, when testing patient, the resistance measuring signals measurement The dermatopolyneuritis 225 being coupling between conductive tip 115 and electrode 120.Indicator 215 is reacted by the resistance of the circuit measuring Value, and visual detector, sound indicator and/or vibration indicator can be provided.For example, indicator 215 can be relative to institute The value of the dermatopolyneuritis 225 measured and change the buzzer of tone, with doctor nearby move conductive tip 115 with contact suffer from The different parts of person's skin surface, the tone of the buzzer can change.
When patient is in test, autonomic nerves system stimulator 220 is suitable to generation to be believed coupled to the electrotherapy of conductive tip 115 Number, the electrotherapy signal is hereinafter also referred to as " cyclical signal " or " time cycle property signal ", and the conductive tip 115 pierces Swash the vagus nerve reaction of patient's autonomic nerves system.When patient is in test, conductive tip 115 provides electrical contact but not pierced through Patient skin surface part.
Electrode 120 puts on other positions at the tested position different from skin surface, to optimize the arrangement of electrotherapeutic needle. Electrode 120 be suitable to be resistance measuring signals or electrotherapy signal return signal path, that is, be grounded so that glove doctor Raw (being hereinafter also referred to as " tester ") is easy to apply resistance measuring signals or electrotherapy signal to patient.Electrode 120 can be with It is a part for the metal foil being pasted onto temporarily on patient skin or the electrotherapeutic needle being temporarily placed in patient skin.
Shell 223 can have insulating surface and at least one hole in insulating surface, conductive tip 115 to pass through the hole Outside that is prominent or reaching shell.Shell 223 can encapsulate battery 217 and circuit.When testing skin surface, the shell can With suitable for hand-held shape.In other words, the shell is configured to when using autonomic nerves system sensitive spot tester 110 It is adapted to the shape caught by the hand of people.The insulating surface of the shell can have other holes, such as, it is allowed to tester's operation is opened Close other holes of 230 and electrode 120.Shell 223 airtight potted circuit and can seal the hole, such as by conductive tip week Enclose and use elastic washer, in order to clean and sterilize during use autonomic nerves system sensitive spot tester 110 in test.
Arranged due to electrotherapeutic needle and pierce through skin, accordingly, it may be desirable to which doctor wears gloves during pin is arranged.Previous sensitivity The design of point tester provides return signal path via the naked hand of doctor, and the naked hand of doctor must be through placing and sensitive spot tester Outer cover metal contact.On the contrary, being designed compared to previous sensitive spot tester, there is provided electrode 120 is favourable, because Doctor in patient's test site 100 without removing gloves.
Coupled to switch 230, switch 230 can be had for electric resistance measuring apparatus 210 and autonomic nerves system stimulator 220 Position B, A double pole double throw switch, electrotherapy signal or electric resistance measuring signals optionally can be coupled to conductive tip by it 115, while corresponding return signal is coupled to electrode 120.Therefore, when switch 230 is in position A, circuit 110 is in resistance Measurement pattern, when switch 230 is in position B, circuit 110 is in autonomic nerves system pattern.
Fig. 3 shows the simplification frame of the autonomic nerves system stimulator 220 shown in Fig. 2 according to an embodiment of the invention Figure.Fig. 3 shows autonomic nerves system stimulator 220, and it includes impulse generator 310, control unit 320 and wireless transceiver 330.Impulse generator 310 provides electrotherapy signal, and it includes the characteristic of such as frequency, amplitude, pulse shape and dutycycle, described Characteristic is set by control unit 320.Electrotherapy signal can be similar or equivalent to the used signal during long-term Electrotherapeutic therapy.Control Unit 320 processed is coupled to wireless transceiver 330, and the wireless transceiver 330 can receive the featured configuration from computer 165 simultaneously The characteristic of impulse generator 310 is set.Control unit 320 also can perform electricity-saving function, all as in response to the position of switch 230 is broken Drive electric resistance measuring apparatus 210 or autonomic nerves system stimulator 220.
Wireless transceiver 330 need not have the ability of high bandwidth or longer transmission distance, because autonomic nerves system is sensitive Point tester 110 can be handheld portable devices, and power saving is probably favourable to extending battery life.Therefore, wireless receiving and dispatching Device can be in low bandwidth, power saving radio frequency transmission standard such as Middle work.
Fig. 4 A describe according to an embodiment of the invention sensitive for carrying out autonomic nerves system on the skin of the patient The simplified flowchart of the method 400 of point test.With reference to Fig. 2 and Fig. 4 A, methods described 465 starts from 470 healthcare givers production Raw electrotherapy signal, wherein when the parasympathetic system for being used in autonomic nerves system pattern (setting switch 230 to be in position B) When sensitive spot tester 110 of uniting tests patient, the electrotherapy signal stimulates the vagus nerve reaction of the autonomic nerves system of patient. When testing patient, 475 offer conductive tips 115 make electrical contact with but do not pierce through skin surface.Switch 230 is set to make in position B Obtain 480 electrotherapy signals and be coupled to conductive tip 115, as described above.Therefore, before the embodiment completes 485, parasympathetic system System susceptibility test device 110 is arranged to perform skin surface test with patient.
Fig. 4 B describe according to an embodiment of the invention sensitive for carrying out autonomic nerves system on the skin of the patient The simplified flowchart of the method 405 of point test.With reference to Fig. 1 and Fig. 4 B, in one embodiment, methods described starts from 410, substantially determine pin position using the locator application run on computer 165 by 415.In other words, by from coupling Close perform reaction patient symptom program computer 165 graphical user interface 160 obtain preliminary skin site (for example, On ear), to select the Part I of patient skin.For example, patient can tell low-back pain to healthcare givers.Medical people Member can select the symptom on graphic user interface 160, and this can be reacted to show the approximate location, wherein pin on ear figure Moxibustion therapy is associated with the small of the back treatment.
With reference to Fig. 2 and Fig. 4 B, also (can be opened by using in step 415 in resistance measurement pattern by setting Close and 230 be in position A) under the region that is identified of the 420 low resistance points of determination of autonomic nerves system susceptibility test device 110 that operate The first parts of skin of interior selection, comes location-sensitive point position.Then electric resistance measuring apparatus 210 generates resistance measuring signals, the electricity Resistance measurement signal is coupled to conductive tip 115.Electrode 120 is applied in Second Skin part, and the electrode is to be surveyed for resistance Measure the return signal path of signal.
Resistance measuring signals and then can be put on the first parts of skin by healthcare givers with conductive tip 115, wherein working as survey When trying patient, the conductive tip is made electrical contact with but does not pierce through skin, and the resistance at the first parts of skin is filled by resistance measurement 210 measurements are put, and cause indicator 215 to provide the instruction of the reaction value of dermatopolyneuritis 225, that is, change the institute related to described value The acoustic tones sent.In response to the instruction, healthcare givers moves or detected on a skin surface conductive tip, to select Find to selecting property the skin low resistance position near the first parts of skin.
Healthcare givers can and then further (be switched at 230 by using in autonomic nerves system pattern by setting In position B) autonomic nerves system susceptibility test device 110 determine 425 reconnaissances autonomous sensitiveness, to optimize electrotherapeutic needle Insertion position.Then autonomic nerves system stimulator 220 generates electrotherapy signal, and the electrotherapy signal is coupled to conductive tip 115.Such as Fruit does not apply electrode 120 during step 420, then electrode 120 is put on into another parts of skin, and the electrode is for electrotherapy The return signal path of signal.
Healthcare givers and then can put on electrotherapy signal selected parts of skin with conductive tip 115, wherein working as survey When trying patient, the conductive tip 115 makes electrical contact with but does not pierce through skin.When testing patient, when conductive tip 115 is oriented to When being contacted with the autonomic nerves system sensitive spot on skin surface, electrotherapy signal can stimulate the fan of the autonomic nerves system of patient to walk Nerves reaction.With reference to Fig. 1 and Fig. 4 B, to measure autonomic nerves system, healthcare givers is by autonomic nerves system monitor 135 It is coupled to patient, as described above.Autonomic nerves system monitor 135 analyzes the autonomic nerves system of patient according to time varying signal State, wherein the time varying signal represents the chaos of the time interval between the paracycle event as caused by the cardiac system of patient Sequence, i.e., according to the electrocardiogram of patient.Autonomic nerves system monitor 135 also measures and shows that the first sympathetic fan of patient is absent-minded Through balance.
Fig. 5 is depicted in the exemplary reaction of the sympathetic vagus nerve balance 500 used in the method 425 shown in Fig. 4 B.Fig. 5 Describe sympathetic vagus nerve balance 500, the trimming trajectory 530 of its real-time rendering patient, such as a series of arrows on trimming trajectory It is shown.Parasympathetic nerve or vagus nerve of the transverse axis expression on the direction towards larger negative (i.e. towards the left side of figure) are anti- Should.On the contrary, sympathetic nerve reaction is indicated in figure on the smaller negative direction of transverse axis (i.e. towards the right of figure).With the time The sympathetic nerve of the change track 530 that tends to be balanced shows cumulative pain or dysfunction, while vagus nerve tends to be balanced rail Mark shows pain relief.In this example, patient can be by anxiety caused by clinical setting, and the trimming trajectory 530 of patient is opened Begin generally away from transverse axis parasympathetic nerve or vagal components and towards as point 510 indicated by sympathetic nerve direction shifting It is dynamic.
With reference to Fig. 4 B and Fig. 5, healthcare givers is based on sympathetic vagus nerve balance and determines 430 reaction results.When sympathetic Vagus nerve balance is towards during vagus nerve reaction movement, and as shown in point 520, reaction result is positive, and this shows conductive sharp End 115 is positioned optimally on a skin surface and the autonomic nerves system of patient successfully responds electrotherapy signal.On the contrary, work as When sympathetic vagus nerve balance moves not towards sympathetic reaction, reaction result is negative.
When reaction result is bears, healthcare givers checks the skin portion of 435 or the adjacent patient previously selected of selection Divide and slightly different adjacent skin part.Healthcare givers's repetitive administration electrotherapy signal, sympathetic vagus nerve balance is measured, and Reaction result is determined, untill reaction result is positive or until testing certain amount of parts of skin or more than pre- timing Between untill.
When reaction result is positive, healthcare givers inserts 440 electrotherapeutic needles at the parts of skin.Selected by said procedure The electrotherapeutic needle position selected has been tested at step 430 in the early time, and the position is put on during therapeutic scheme so as to improve Identical electrotherapy signal should have the confidence level of desired beneficial effect to the autonomic nerves system of patient.
Pin insertion will cause mild pain, deviate so as to form sympathetic nerve, at the point 510 such as on trimming trajectory 530 Shown, it should rapid regression or reverse.However, pin insertion position may will stimulate undesirable long pain to react Point at.Therefore, after pin insertion, healthcare givers measures the second sympathetic vagus nerve balance of patient, to be handed over based on second Feel vagus nerve balance and determine that 445 sympathetic nerve deviate reversion result.When the second sympathetic vagus nerve balance is anti-from sympathetic nerve When should be reversed to vagus nerve reaction, the reversion result is positive, as shown in the point 520 on trimming trajectory 530.When second When sympathetic vagus nerve balance is not reversed to vagus nerve reaction from sympathetic nerve, the reversion result is negative.
When inverting result to bear, electrotherapeutic needle is removed 450 by healthcare givers from the parts of skin, and by pin somewhat Side is moved to select another parts of skin of parts of skin before adjoining.Healthcare givers is repeatedly inserted into, and measurement second is sympathetic Vagus nerve balances, and determines to invert result, untill reversion result is positive or until certain amount of skin portion It is point tested or more than special time untill.
Electrotherapeutic therapy may need more than one stimulation point on the ear of patient.For example, a point can be stimulated to solve Low-back pain, and another point can be stimulated to mitigate overall pain.Therefore, when the reversion result at step 445 is positive When, healthcare givers determines the quantity of 455 electrotherapeutic needles inserted.When the quantity of the electrotherapeutic needle inserted is equal to needed for Electrotherapeutic therapy Electrotherapeutic needle predetermined quantity when, test terminates 460, such as three root thorns swash a pin-piece pin and positioned for specific symptoms and two Root pin mitigates for overall pain and is positioned at two diverse locations.When the quantity of the electrotherapeutic needle inserted is less than the pre- of electrotherapeutic needle During fixed number amount, healthcare givers repeats selection position, using electrotherapy signal, the sympathetic vagus nerve balance of measurement first, it is determined that reaction As a result, pin, the sympathetic vagus nerve balance of measurement second are inserted, and determines reversion result.
Fig. 6 shows that patient according to an embodiment of the invention treats the simplified block diagram at scene 600.Patient treats scene 600 include the similar elements of patient's test site 100 shown in Fig. 1, except the autonomic nerves system sensitive spot tester in Fig. 1 110th, conductive tip 115 and electrode 120 replace with electrotherapy stimulator 610, electrotherapeutic needle 615 and the conductive electrode 620 in Fig. 6.Electricity Treat pin 615 and conductive electrode 620 is coupled in electrotherapy stimulator 610.With sophisticated being led including preventing from piercing through the small and blunt of skin Electric tip 115 is different, and electrotherapeutic needle 615 includes short, sharp conductive electrode pin, suitable for make electrical contact with and pierce through a part for skin surface with Electrotherapy signal is injected into below skin surface.
The autonomic nerves system that electrotherapeutic needle 615 is located at described in the usable reference chart 1 in position and Fig. 2 on ear 125 is sensitive Point tester 110 with earlier reference to the step described in Fig. 4 A and 4B by determining.Different from as handheld apparatus and being only used for The autonomic nerves system sensitive spot tester 110 of electrotherapeutic needle position is placed in test, and electrotherapy stimulator 610 can be attached for a long time The wearable device of electrotherapy signal is conveyed with patient, to the pin laid in skin.In the placement process of electrotherapeutic needle 615 In, autonomic nerves system monitor 135 is attached with patient, but is separated during Electrotherapeutic therapy with patient, so as to Mobility during treatment is provided for patient.During pin is placed on the setting of skin, wireless transceiver 175, figure are used Family interface 160 and computer 165 refer to Fig. 1,2 and 3 using with to electrotherapy stimulator 610 transmit electrotherapy signal characteristic.
With reference to figure 6, conductive electrode 620 can be similar to electrode 120 and suitable for making electrical contact with but not piercing through in skin surface with inserting Enter other different positions of the position of electrotherapeutic needle.Conductive electrode 620 can carry between the surface of conductive electrode 620 and skin surface For directly electrical contact, so as to provide the return signal path of electrotherapy signal when cyclical signal is injected below skin surface. When alternatively using adhesive glue between skin and electrode, the signal attenuation avoided the occurrence of is directly made electrical contact with.Conductive electrode 620 can Tie up on skin to be attached for a long time.Conductive electrode 620 may include the short strip gold coupled to electrotherapy stimulator 610 via flexible circuit conductor Belong to paper tinsel.Alternatively, conductive electrode 620 may include the thin flexible knitting wire for coupling directly to electrotherapy stimulator 610.
Fig. 7 shows the patient shown in the simplified block diagram and Fig. 6 of electrotherapy stimulator 610 according to an embodiment of the invention A part for skin 125.Fig. 7 shows electrotherapy stimulator 610, and it includes autonomic nerves system stimulator 220, one or more electricity Treat pin 615A, 615B, battery 717, shell 723 and electrode 620.When battery 717 provides compact power to circuit and allows long Between work.It can be similar to be included in electricity as shown in Figure 7 referring to figs. 2 and 3 previously described autonomic nerves system stimulator 220 Treat the autonomic nerves system stimulator 220 in stimulator 610.One or more electrotherapeutic needle 615A, 615B can be coupled in parallel to certainly Electrotherapy signal (SIG) line output terminal of main nervous system stimulator 220.
Shell 723 can have insulating surface and at least one hole in insulating surface, and electrotherapeutic needle 615A can be located at shell Outside is simultaneously coupled to autonomic nerves system stimulator circuitry by the hole.Shell 723 can be gas-tight seal or encapsulates battery and oneself Main nervous system stimulator circuitry.Shell 723 is adapted to conform to skin when can have below cyclical signal injection skin surface The shape of the part on surface.For example, when electrotherapy stimulator 610 is arranged on the flat part of skin, the shape of shell can With flat surfaces, or when on the position with profile installed in skin, the shape of shell can have the table for forming profile Face.Shell 723 can be attached to skin via band or adhesive.For example, shell 723 can be used in attachment electrotherapeutic needle 615A, 615B Ear around until ear surface before flexible wire skin of the head behind and below ear is attached to by tack coat On skin.Electrode 620 can be tied up on inner face or skin surface below of the ear towards head.
Fig. 8 shows the method 800 for being used for electrotherapy signal and being injected into patient skin according to another embodiment of the present invention Simplified flowchart.With reference to figure 3,6,7 and 8, methods described starts from 810, there is provided 820 batteries 717, rf receiver and transmitter 330 and one or more electrotherapeutic needle 615A, 615B.Electrotherapy signal is to stimulate the vagus nerve of the autonomic nerves system of patient anti- The time cycle property signal answered, the circuit evolving 830 in its stimulator 610 that applies medical diathermy.Electrotherapy stimulator 610 can be via wireless The input of transceiver 330 receives the characteristic of 840 cyclical signals.Control circuit 320 then can exist the featured configuration 850 In the circuit of impulse generator 310.
Periodicity electrotherapy signal couples 860 to electrotherapeutic needle 615.When electrotherapeutic needle 615 is inserted in skin by doctor, pass through institute State electrotherapeutic needle to make electrical contact with and pierce through 870 skin surfaces, below a part for cyclical signal injection skin surface.Insert pin The method described in reference chart 4A, 4B and the autonomic nerves system sensitive spot tester with reference to described in figure 1,2 and 3 can be used in position 110 determine.After the electrotherapeutic needle in skin is set, electrotherapy stimulator is attached to patient, and the autonomic nerves system of patient is able to Test.Then, autonomic nerves system monitor 135 can be disconnected, in electrotherapy stimulator 610 in treatment that is predetermined and/or extending When conveying stimulates the recurrent pulses of vagus nerve reaction of autonomic nerves system in time, patient can carry out his or her routine Activity.
When completing a wheel electrotherapy, patient can return to, and be carried out further using autonomic nerves system monitor 135 by doctor Monitoring, take turns pretherapy and post-treatment quantitative measurment herein by comparing patient's autonomic nerves system to quantitatively determine treatment results.Electricity Treating the setting of stimulator 610 can be adjusted between Electrotherapeutic therapy wheel number to optimize treatment.For example, when being treated, by Neural passivation in electrotherapeutic needle position, doctor can improve the amplitude of electrotherapy signal, and autonomic nerves system can be used in the raising amplitude Monitor 135 is determined by Quantitative Monitoring patient.
Electrotherapy signal characteristic may influence treatment results.For example, Fig. 9 shows the electrotherapy signal injection pair of peer review document The statistical chart of patient's response of electrotherapy signal frequency.Frequency characteristic is shown along the transverse axis in below 200Hz scopes.Respectively in 1Hz In the range of 10Hz, responded with the following treatment of increasing frequency order observation;Melatonin secretion 910, nerve regneration, neural process Hyperplasia 915, osteogenic action 920, cartilage 925, bone uptake 930, Ligament healing, cell growth, osteogenic action, collagen produce With DNA (DNA) synthesis 935.In about 20Hz, it was observed that cutaneous necrosis reduction, angiogenesis, fibroblast increase Grow and osteogenic action 940.In about 25Hz, it was observed that nerve growth 945.In about 30Hz, it was observed that nerve growth, osteogenic action and Lymphocyte activator 950.In about 70Hz, it was observed that cutaneous necrosis is reduced, angiogenesis and fibroblast proliferation 955, about 95Hz, it was observed that osteogenic action, bony defect and DNA synthesis 960.In about 200Hz, it was further observed that osteogenic action 965.Therefore, The frequency characteristic of the cyclical signal generated by impulse generator 310 is arranged to associated with the therapeutic response pattern of patient Preset frequency can improve or accelerate Electrotherapeutic therapy result.
The above embodiment of the present invention is illustrative and not restrictive.Various alternative solutions and equivalent are possible 's.Although describing the present invention with reference to human patientses by way of example, it is to be understood that, the invention is not restricted to patient's Type, as long as patient has autonomic nerves system and cardiac system.Although acupuncture ear acupuncture electrotherapy is referred to by way of example Method describes the present invention, it is to be understood that, the invention is not restricted to the position of tested parts of skin, at least described position has Autonomic nerves system sensitive spot.For the disclosure, other supplements, delete and modification is it will be apparent that and each falling within appended Scope of the claims.

Claims (8)

1. a kind of electric device, including:
Battery;
Suitable for generating the circuit of cyclical signal;
Rf receiver and transmitter;
Suitable for the control circuit for the characteristic for setting the cyclical signal, the characteristic of the cyclical signal is by the less radio-frequency The input of transceiver receives;
First conductive electrode, when the cyclical signal is injected below the Part I on surface, first conductive electrode is fitted In making electrical contact with and piercing through the Part I on the surface, wherein the cyclical signal is coupled to first conductive electrode and draws Play monitoring for the balance of the sympathetic vagus nerve between the parasympathetic nervous division and sympathetic division of autonomic nerves system Change;
Second conductive electrode, it is suitable to electrical contact but does not pierce through the Part II on the surface;And
Autonomic nerves system monitor, be adapted to monitor for based on represent between event paracycle caused by the cardiac system of patient when Between between the parasympathetic nervous division and sympathetic division of the autonomic nerves system of the time varying signal of chaos sequence that are spaced Sympathetic vagus nerve balance, and the change instruction of the sympathetic balance as caused by periodic signal is provided.
2. electric device according to claim 1, second conductive electrode provides second conductive electrode and described Direct electrical contact between the Part II on surface, when the cyclical signal is injected below the Part I on the surface, Second conductive electrode provides the return signal path of the cyclical signal.
3. electric device according to claim 1, in addition to insulating surface and in the insulating surface at least The shell in the first hole, first conductive electrode are suitable to be positioned at the enclosure and by first hole coupled to described Circuit, battery described in the shell enclosure and the circuit.
4. electric device according to claim 3, wherein, when the cyclical signal injects the Part I on the surface When below, the shell is suitable to the shape with the Part III for being adapted to conform to the surface.
5. electric device according to claim 3, wherein, the shell is suitable to the gas-tight seal electric device.
6. electric device according to claim 1, wherein, the rf receiver and transmitter by selected from OrIn transmission standard carry out work.
7. electric device according to claim 1, wherein, the characteristic is selected from frequency, amplitude, pulse shape and duty Than.
8. electric device according to claim 1, wherein, the set of frequency of the cyclical signal is preset frequency.
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US10413719B2 (en) 2016-04-15 2019-09-17 Innovative Health Solutions, Inc. Methods of treating disease using auricular peripheral nerve field stimulation
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