CN100337703C

CN100337703C - Method of improving efficacy and synsory tolerance with continuous pulse, non-modulated non-burst mode nerve stimulator

Info

Publication number: CN100337703C
Application number: CNB96180503XA
Authority: CN
Inventors: 罗伯特·R·霍尔库姆
Original assignee: Individual
Current assignee: Grey Dirnt Technologies Ltd
Priority date: 1996-06-19
Filing date: 1996-06-19
Publication date: 2007-09-19
Anticipated expiration: 2016-06-19
Also published as: CN1234744A; CN101172189A

Abstract

The present invention relates to an apparatus for treating pain of a human body. The apparatus applies electric stimulation pulse with proper electric current density, and reaction modulated by a magnetic field to the surface of a human body, so that the excitation rates of peripheral nerve cells with mechanical stimulation sensitivity of fibers (A, C) can be controlled, and long-term severe pain can be harmoniously controlled so as to avoid discomfort due to stimulation. A treatment apparatus electrode (10) comprises an attachment device (11) which is used for contacting an electrode (12) and a magnetic flux generator with a human body, wherein the composite electrode (12) is preferably composed of four electrodes. Two of the electrodes are positive electrodes, the rest are negative electrodes, and all the electrodes are respectively arranged at the diagonal tops of a quadrangle.

Description

Improve the method for effect and sensation toleration with continuous impulse non-modulated non-burst mode nerve stimulator

The application quotes following application as a reference and requires its priority: the application number with application on March 22nd, 1988 that is entitled as " being used for the therapy equipment of epilepsy and brain swelling " of application on June 19 nineteen ninety-five is 171837 the relevant interim U.S. Patent application 60/000317 of U.S. Patent application, U.S. Patent application 171837 is part continuation applications of the U.S. Patent application 939950 of December in 1996 application on the 9th, and patent application 939950 is again the part continuation application of the U.S. Patent application 934568 of in November, 1986 application; June 19 nineteen ninety-five application be entitled as the relevant interim U.S. Patent application 60/000,300 of U.S. Patent application " being used for the therapy equipment of arrhythmia " and application on March 22nd, 1988 171837; June 19 nineteen ninety-five application be entitled as the relevant interim U.S. Patent application 60/000299 of U.S. Patent application " being used for the therapy equipment of violent burn " and application on March 22nd, 1988 171837; The interim U.S. Patent application 60/000318 that is entitled as " utilizing the looking of non-modulation non-short burst mode of continuing pulse to improve the method for rendeing a service and feeling to bear " of application on June 19 nineteen ninety-five through stimulator; The interim U.S. Patent application 60/001012 that is entitled as " the method for utilizing the four end shape distributional stability magnetic fields of regulating by the non-modulation non-short burst mode nerve stimulator of continuous impulse " of application on July 10 nineteen ninety-five to local analgesis and/or anesthesia inducing; And its continuation application of the U.S. Patent application 07/844904 of application on April 28th, 1992 and application on January 16th, 1996.

The present invention relates to electronic therapy device field, device more specifically to the treatment human body pain, its by applying electric stimulation pulse from suitable electric current density to human body surface and by the response of magnetic field modulation, with the incentive rate (firingrate) of the peripheral nerve unit of the nociceptor of control category-A fiber and C fibrid, thereby control chronic pain and severe pain consistently and can be uncomfortable owing to stimulation.

People such as Maurer point out 1994 (No. 4431002, patent), and pain can be by to human body surface or be embedded in intravital electrode to apply that electric pulse alleviated be known.His disclosure of the Invention a kind of electrical nerve stimulation device of percutaneous, wherein mode is according to the rules being modulated boost pulse aspect the time and intensity two, pulse amplitude and width reduce, and pulse recurrence rate increases; Perhaps opposite.The advantage of this device it is said the stimulation that is enough to produce muscle contraction and dark nervus centripetalis with cause be considered to can inhibition of pain such as the level of disengaging of Gum preparation in the endorphins etc. under the comfortable and happy sensation of generation.

People such as Deyo (NEJM) conclude, transcutaneous electrical neural stimulation (Transcutaneous ElectricalNerve Stimulation) (TENS) concerning the patient who suffers from chronic back bottom pain with to utilize placebo treatment to compare more ineffective, TENS is not to only having tangible additional effect by tempering producing effects of being obtained, clearly, these researchs are suitably not use and using under the situation of described technology and make.In addition clearly, the technology that needs easy to understand and operator to use.

The reduction of the C fibrid input usefulness that causes by common activation mechanical stimulus susceptibility category-A fiber is the principle that constitutes through skin electrical nerve stimulation (TENS).Related mechanism is called " pain is experienced the gate theory " (Gate Control Theory of Pain Perception) (see figure 5).

The gate theory is proposed in nineteen sixty-five by Melzack and Wall.Among Fig. 5, the target erythrocyte of T representative in dorsal part ash angle.The thorn of target erythrocyte is goaded into action to beat and is passed to the higher center of pain impression.Gelatinous substance of spinal cord (SG) suppresses to stimulate the fiber of target erythrocyte.Little centripetal fiber (pain conduction) suppresses SG, has therefore strengthened the pain impression.Big sensory fiber (mechanical stimulus susceptibility fiber 203) stimulates SG, has therefore reduced the pain impression.Among Fig. 5,201 expression skins " sensor ", 202 expression Wagner's corpuscless, the big mechanical stimulus susceptibility fiber of 203 expressions, 204 expression " A " fibrids (30-300Hz), 205 expression outputs, 206 expression Ca ⁺⁺Generator potential, the little centripetal fiber of 207 expression conduction pain, the free teleneuron of 208 expressions, 209 pain that are illustrated in higher center are experienced (proportional with driving frequency), and 210 expression " C " fibrids.

The electricity that TENS relates to mechanical stimulus susceptibility fiber activates (electrival activation).Mechanical stimulus susceptibility category-A fiber is activated under lower intensity of electric stimulus than C fibrid, and promptly the category-A fiber has lower threshold value.Therefore, the category-A fiber can utilize low intensity to stimulate optionally to activate and not increase the incentive rate of C fibrid, and promptly the category-A fiber can utilize low intensive electricity irritation optionally to activate under the situation of the incentive rate that does not increase the C fibrid.When the increase of stimulus intensity, can activate machinery and swash susceptibility and nociception fiber.Therefore, for the stimulation size that present TENS operation can be applied certain limitation is arranged.Use the patient of TENS device fully to recognize, if increase continuously stimulus intensity, they can feel more pain rather than ease the pain.Because stimulating and increasing pain is because the C fibrid activates.In some cases, can be simply still reach simultaneously category-A fiber threshold value and just can reduce and reach the required stimulus intensity that eases the pain by reorientating electrode and reducing current flux by tissue.Under the other situation, can not under enough low intensity, optionally activate the category-A fiber and reach and ease the pain.In these cases, pain may increase, and TENS to be said to be to lose efficacy.Under the situation of these inefficacies, available data thinks that the TENS inefficacy mainly is owing to unsuitable electrode position and is expecting the electric current or the electric current density deficiency of stimulation point.

Document, clinical observation and isolated neurocyte prepare data and show, carry out continued stimulus with high current density with high frequency in the stimulation district and can make the effectiveness of this device reach maximum.The pace-making of category-A fiber (pacing) guarantees pain management syndrome reliably together with the activated inhibition simultaneously of C fibrid.In order to realize effectiveness of the present invention, the quadrupole array of forming by anodal and negative pole according to the tetragon array arrangement, thus positive pole and negative pole are suitably approaching nearly each other, can obtain high electric current density in the nerve fiber zone for the treatment of pace-making like this.Another object of the present invention is to suppress the activity ratio of C fibrid when increasing category-A fiber activity ratio.This purpose is by with a Magna Bloc ^TMDevice is placed on the interior realization of stimulating electrode.This device, as after will be described, can control and reduce C fibrid excitation astoundingly.This effect to the excitation of C fibrid schematically illustrates in Fig. 7, and wherein TH represents threshold value, and ST represented threshold value, and MBT represents as Magna Bloc ^TMThreshold value when device is placed on the stimulating electrode.As Magna Bloc ^TMWhen device was placed on the stimulating electrode, volunteers experienced pain threshold when doubling voltage (changing electric current into).Root is by kind of a maneuver, and the encoded normal excitation mode transfer of frequency arrives the central nervous system, thereby sense is led comfortable rather than pain.

The every unit of apparatus of the present invention is made up of four electrodes.Each electrode comprises four electrodes of alter polarity, comprises two positive poles and two negative poles.The positive pole of electrode assembly (electrode head) and negative pole levelling are in a single plane basically and press tetragon configuration location, and each positive pole is located to such an extent that the diagonal angle is relative each other, and each negative pole is located to such an extent that the diagonal angle is relative each other.That embed each electrode is Magna Bloc in No. 5312321, United States Patent (USP) (incorporated by reference here) ^TMDevice.This device can make the stimulation of category-A fiber reach maximum, and can be because of C fibrid pain and muscle contraction discomfort.Magna Bloc ^TMControl nervimuscular irritability and stop the excitation of C fibrid.

Another object of the present invention is to keep an electric current density, and it is enough to beat cornu dorsale in the nerve distribution area territory that is transferred to the C fibrid that comprises in the pain syndrome of category-A fiber is in enough intensity to stop C fibrid input central nervous system.The Magna Bloc of control C fibrid excitation when this rises on the common C fibrid threshold value by being used in intensity ^TM, place each electrode correctly contiguous each other, and realize by a current probe being placed on four mid points between the electrode.This detector compensates balanced balanced current density by four electrodes of rotation monitoring and by changing input, makes that electric current density or the electric current in the skin kept constant.This loop will have scope monitor and warning system.Electric current in each electrode changes through two seconds every, in Fig. 1 B to A and C to D, C to A and B to D.

A further object of the present invention is that each TENS unit has two or more this four electrod-arrays.

Except pointing out above, this unit uses and adopts the standard TENS electronic installation with following parameter:

1) each parameter is input current intensity 0-100mA, frequency 0-200Hz, pulse width 400 microseconds.This device is effective to dorsal column or nervus centripetalis bundle and pain sensitizing range.Fix four electrodes, four Magna Bloc ^TMThe device and the accommodating device of electric current density detector and electronic pads provide by treating requirement alternation electrode DC frequency modulating device have been placed on method on the human body that eases the pain, modulating device is controlled electric current density well, and wherein the excitation of C fibrid utilizes the Magna Bloc that produces 60 ° to 70 ° flux field gradient along " Z " axle ^TMControlled.

This has also realized the repetition of these steps on the one hand, so that other accommodating body is placed on the human body in other placement location.

Fig. 1 is the perspective view (distance between the Meissner oscillator 13 is about 5cm) of each electrode of therapy equipment according to an embodiment of the invention;

Fig. 2 is that wherein, I represents intensity to the plane graph of the therapy equipment of electrode power supply shown in Fig. 1 (neural pacemaker), and F represents frequency, and D represents the persistent period;

Fig. 3 is a magnetic field intensity of representing the quadrupole magnetic part of electrode in this device with graphics mode, is by using " Hall effect " side head and standard Gaussmeter at Magna Bloc ^TMScan definite in system's parallel plane of top, the plane 0.3cm of device;

Fig. 4 represents to be provided with the use location of electrode of the present invention.

Fig. 5 is that the door of pain perception is theoretical;

Fig. 6 is the sketch map that the anatomy that is associated with pain perception is got in touch;

Fig. 7 is when utilizing Magna Bloc ^TMWhen system is treated about the somesthesia changes of threshold figure of electricity irritation;

Fig. 8 is illustrated in hyperesthesia and hyperalgesic scope in the right arm of first object of three objects in the nineteen ninety-five test;

Fig. 9 is illustrated in hyperesthesia and hyperalgesic scope in the left arm of first object of three objects in the nineteen ninety-five test;

Figure 10 is illustrated in hyperesthesia and hyperalgesic scope in the right arm of second object of three objects in the nineteen ninety-five test;

Figure 11 is illustrated in hyperesthesia and hyperalgesic scope in the left arm of second object of three objects in the nineteen ninety-five test;

Figure 12 is illustrated in hyperesthesia and hyperalgesic scope in the right arm of first object of three objects in the nineteen ninety-five test;

Figure 13 is illustrated in hyperesthesia and hyperalgesic scope in the left arm of first object of three objects in the nineteen ninety-five test;

Figure 14 is illustrated in comfort and Magna Bloc ^TMHyperalgesic assessment in the arm of treatment, wherein, numeral 901 to the 905 expression Magna Bloc in left side ^TMEach arm of treatment, and the numeral on the right side object identical, but the relative arm of expression comfort treatment with the left side.

In Fig. 8-13, the tape that has oblique line downward-sloping from the right side to the left side is represented hyperesthesia, and the tape that has an oblique line downward-sloping from the left side to the right side is represented hyperpathia.T/RX express time and dosage among Fig. 9-13.

Components list:

The explanation of element number element

1 is used for the position of high-order neck injury

2 waist L ₄L ₅Placement location

3 are used to be secondary to the position of the arthritic hip arthralgia

4 are used to be secondary to the position of arthritic ankle joint pain

5 waist S ₁S ₂Placement location

6 waist L ₅S ₁Placement location

7 are secondary to the position of arthritic elbow joint pain

8 T ₁₂L ₁Placement location

9 T _9-10Placement location

10 therapy equipment electrodes

11 fix the attachment device of each electrode 12 usefulness

12 each electrode

13 Magna Bloc ^TMThe board Meissner oscillator

14 conducting cable

15 leads

16 leads

17 voltage detectors

19 cables

20 joints

21 electrode cables

22 electrode connection cords

23 TENS generating apparatus

24 female joints

25 intensity controllers

26 frequency controllers

27 persistent period controllers

The male joint of 28 electric current density modular cable 19

The female joint of 29 electric current density modular cable 19

110 are used to be secondary to the position of arthritic shoulder arthralgia

111 are used for the position of high-order neck injury

112 are used for the position of high-order neck injury

113 are used for the position of high-order neck injury

114 are used to be secondary to the position of arthritic TMJ arthralgia

115 are used to be secondary to the position of arthritic shoulder arthralgia

116 are used to be secondary to the position of arthritic shoulder arthralgia

117 are used to be secondary to the position of the arthritic hip arthralgia

118 are used to place the active position of therapy equipment of the present invention

119 are used to place the active position of therapy equipment of the present invention

120 are used to be secondary to the position of the arthritic gonalgia

121 are used to be secondary to the position of the arthritic gonalgia

122 are used to be secondary to the position of arthritic ankle joint pain

123 are used to place the active position of therapy equipment of the present invention

201 skins " sensor "

202 Wagner's corpuscless

Fiber is experienced in 203 big mechanical stimuluss

204 " A " fibrid (30-300Hz)

205 outputs

206 Ca ⁺⁺Generator potential

The little centripetal fiber of 207 conduction pain

208 free teleneurons

209 the more distressed pain of senior middle school be subjected to (proportional) with driving frequency

210 " C " fibrid (≤60Hz)

220 cerebral cortex

(frontal) of 221 volumes

222 somathetic areas

223 thalamuses

224 hypothalamuss

225 limbic systems

226 periaqueductal grey matters

227 network structure

228 lateral spinothalamic tracts

229 same lateral bundles (ipsilateral tract)

230 substantia gelatinosa [of Rolandos

231 cornu dorsales

232 peripheral nociceptors

233 main afferent neuron (A-delta﹠amp; C)

301 60M owe threshold value

302 60M threshold values

303 60M cross threshold value

401 are illustrated in the sense of threshold intensity first object left arm after following 15 minutes

Irritated and the hyperalgesic tape of feel

402 are illustrated in hyperesthesia and the pain sensation mistake of threshold intensity after following 30 minutes

Quick tape

403 are illustrated in hyperesthesia and the pain sensation mistake of threshold intensity after following 60 minutes

Quick tape

404 were illustrated in hyperesthesia and the pain sensation of threshold intensity after following 5 minutes

Tape hypersensitive

501 are illustrated in the sense of threshold intensity second object right arm after following 15 minutes

Irritated and the hyperalgesic tape of feel

502 are illustrated in the sense of threshold intensity second object right arm after following 30 minutes

Irritated and the hyperalgesic tape of feel

503 are illustrated in the sense of threshold intensity second object right arm after following 60 minutes

Irritated and the hyperalgesic tape of feel

504 were illustrated in the sense of threshold intensity second object right arm after following 5 minutes

Irritated and the hyperalgesic tape of feel

505 are illustrated in the sense that TENS closes the second object right arm after 5 minutes

Irritated and the hyperalgesic tape of feel

506 expression Magna Bloc ^TMIt's 5 fens is being past under the threshold intensity device

The hyperesthesia of the second object right arm and hyperalgesic tape behind the clock

507 are illustrated in TENS and Magna Bloc ^TMDevice is closed back second pair

Resemble the hyperesthesia and the hyperalgesic tape of right arm

601 are illustrated in the sense of owing threshold intensity second object left arm after following 15 minutes

Irritated and the hyperalgesic tape of feel

602 are illustrated in the sense of owing threshold intensity second object left arm after following 30 minutes

Irritated and the hyperalgesic tape of feel

603 are illustrated in the sense of owing threshold intensity second object left arm after following 60 minutes

Irritated and the hyperalgesic tape of feel

604 were illustrated in the sense of threshold intensity second object left arm after following 5 minutes

Irritated and the hyperalgesic tape of feel

Magna Bloc is used in 605 expressions ^TMIt's 5 fens is being past under the threshold intensity device

The hyperesthesia of the second object left arm and hyperalgesic tape behind the clock

606 are illustrated in TENS and Magna Bloc ^TMDevice is closed back second pair

Resemble the hyperesthesia and the hyperalgesic tape of left arm

701 are illustrated in the sense of threshold intensity the 3rd object right arm after following 15 minutes

Irritated and the hyperalgesic tape of feel

702 are illustrated in the sense of threshold intensity the 3rd object right arm after following 30 minutes

Irritated and the hyperalgesic tape of feel

703 are illustrated in the sense of threshold intensity the 3rd object right arm after following 60 minutes

Irritated and the hyperalgesic tape of feel

704 were illustrated in the sense of threshold intensity the 3rd object right arm after following 5 minutes

Irritated and the hyperalgesic tape of feel

Magna Bloc is used in 705 expressions ^TMInstall the 3rd object right side after 5 minutes

The hyperesthesia of arm and hyperalgesic tape

706 are illustrated in Magna Bloc ^TMDevice is closed after back 5 minutes the 3rd pair

Resemble the hyperesthesia and the hyperalgesic tape of right arm

707 are illustrated in the sensation that TENS closes back 5 minutes the 3rd object right arms

Irritated and hyperalgesic tape

801 are illustrated in the sense of owing threshold intensity the 3rd object left arm after following 15 minutes

Irritated and the hyperalgesic tape of feel

802 are illustrated in the sense of owing threshold intensity the 3rd object left arm after following 30 minutes

Irritated and the hyperalgesic tape of feel

803 are illustrated in the sense of owing threshold intensity the 3rd object left arm after following 60 minutes

Irritated and the hyperalgesic tape of feel

804 were illustrated in the sense of threshold intensity the 3rd object left arm after following 5 minutes

Irritated and the hyperalgesic tape of feel

Magna Bloc is used in 805 expressions ^TMIt's 5 fens is being past under the threshold intensity device

The hyperesthesia of Zhong Houdi three object left arms and hyperalgesic tape

806 are illustrated in Magna Bloc ^TMDevice is closed after back 5 minutes the 3rd pair

Resemble the hyperesthesia and the hyperalgesic tape of left arm

807 are illustrated in the sensation that TENS closes back 5 minutes the 3rd object left arms

Irritated and hyperalgesic tape

901 1991 years research first tested objects

902 1991 years research second tested objects

903 1991 years research the 3rd tested objects

904 1991 years research the 4th tested objects

905 1991 years research the 5th tested objects

The duration of D

The F frequency

H-CM2 hyperpathia-CM2

I intensity

MBT Magna Block threshold value

The SG substantia gelatinosa [of Rolando

ST crosses threshold value

Target erythrocyte in the T dorsal part ash angle

The TH threshold value

T/RX time and dosage

The TS tested object

Below explain in detail some present preferred embodiments of the present invention, the example is represented in the accompanying drawings.Spread all over each figure, identical parts are used identical label mark.

In Fig. 1, schematically illustrate the combination electrode of therapy equipment of the present invention.Therapy equipment electrode 10 comprises an attachment device 11, is used for fixing each electrode 12 and each Magna Bloc ^TMDevice 13 keeps in touch with human body.According to the present invention, electrode 12 preferably is made up of 4 electrodes, and wherein 2 are that anelectrode, 2 are negative electrode, and all electrodes are for limiting the electrode of tetragon to angular vertex.Each electronic pads comprises one and utilizes the aluminum button to fasten Magna Bloc in place ^TM

As embodying Magna Bloc here ^TM13 (Meissner oscillators) comprise four and remain on plastics and put essentially identical magnetic pole in the device, and this device is fixed each magnet (seeing United States Patent (USP) No. 5312321) according to required configuration and along gradient (gradient) (see figure 3) of 60 ° to 70 ° of " Z " axle formation.This gradient is the slope of magnetic field intensity with variable in distance.

This embodiment of the present invention also comprises lead 15 and 16, and they are connected to electrode cable 21 by joint 20.

Lead

15 and 16 is included in the conducting cable 14.Also comprise the voltage detector 17 of a belt electrode connection cord 22 among the present invention, cable 22 finally is contained in the cable 19.

Because this system can keep suitable electric current density or electric current in a continuous manner between electrode in the zone of category-A fiber that the pain syndrome of being treated is comprised and C fibrid, so can produce beneficial effect of the present invention.Utilization is kept required current intensity by the electronic pads 12 of scope monitor (in the enclosure) and warning system control.Utilize voltage monitor 17 to determine current intensity.Arrive A, C to D in electrode B, C changes once to the electric current among the D to A and B per 2 seconds.Because Magna Bloc ^TMDevice 13 is placed in the electrode 12, and than traditional TENS, current intensity can be operated on higher level.(see figure 7) when surpassing C fibrid threshold value, Magna Bloc ^TM13 remove the discomfort that C fibrid excitation (firing) causes fully.Magna Bloc ^TM13 stop the excitation of C fibrids, therefore, can be to category-A fiber/C fibrid than forming favourable balance, therefore make this device very effective aspect easing the pain (seeing all places suggestion for the treatment of shown in Fig. 4).For Magna Bloc ^TMThe excitation of control C fibrid, it must have greater than 45 ° field gradient less than 90 ° at " Z " direction of principal axis.

Fig. 4 represents the placement location at the therapy equipment of some chronic neuralgia syndrome and some chronic arthritis pain syndrome.To being secondary to cervical region nervous system disease, myelopathy and/or arthritic cervical pain syndrome-include 1,111,112 and 113 for high-order neck injury.Position 110,115 and 116 is used to be secondary to the arthritic arthralgia of shoulder, position 7 is used to be secondary to the arthritic arthralgia of ancon,

position

3 and 117 is used to be secondary to the arthralgia of coxa joint inflammation,

position

120 and 121 is used to be secondary to the arthritic arthralgia of knee,

position

4 and 121 is used to be secondary to the arthritic arthralgia of ankle, and position 114 is used to be secondary to the arthritic arthralgia of TMJ.Chest, waist sacral nerves and spinal cord pain, accurate location depends on the pathology position;

Position

8 and 9 illustrates T respectively ₁₂L ₁And T _9-10Placement location; Waist L ₄L ₅, S ₁S ₂And L ₅S ₁Treat according to 2,5 and 6 positions respectively.

Controlling organization in this therapy equipment shown in Fig. 2 comprises a TENS generator unit 23, it comprises: battery supply, pulse generator, intensity controller 25, frequency controller 26, persistent period controller 27, electric current density polarity of modulation conversion equipment has the electric current density modular cable 19 of male joint 28 and female joint 29.Female joint 24 is inserted in the male joint of cable 14.In housing, comprise on-off and stand by lamp.

Support experimental data

Catalogue

The I foreword

A pain

B pain pathways and pain perception

C pain beat (impulse) take place

The interrupt method that II pain is beaten

The a electricity irritation

bMagna?Bloc ^TM?TMNS

III figure

Sum up and conclusion

Data in this file show, apparatus of the present invention can stop the indirect pain of C fibrid and to the caused hyperpathia of volunteers' subcutaneous injection capsaicin.(electric current or electric current density are that the voltage by any position from the stimulating electrode to the treatment region calculates to electric current density among Fig. 8, resistance is calculated by ohm circuit, and utilize voltage and resistance, just can be easy to calculate electric current density) amount response curve and Figure 10 and 11 displayed contents have proved this response, hyperpathia zone increase (A-B-A observation) after this device was closed 5 minutes well.Figure 10 and 11 shows that the present invention is the collaborative influence that nociceptor is input to the central nervous system to a common approach.

The I foreword

A. pain.Pain is a kind of multifactor consciousness.The international association of pain research is defined as pain " the impression on the uncomfortable and emotion relevant with tissue injury reality or potential.”

The central nervous system that B pain pathways and pain perception pain pathways stimulate integrates and occurs in cerebral cortex.Fig. 6 illustrates schematically illustrating that the dissection relevant with pain perception get in touch.The generation of beating starts from the nociceptor 232 of periphery usually.Main afferent neuron 233 mainly is A triangle (A-delta) and C fibrid.Pain intensity is relevant with the driving frequency of beating along this approach.Final pain intensity and the sensation of various structure influences that has contact along pain pathways.Very complicated loop influence comprises two kinds of pain perceptions of irritability and inhibition relation.

In Fig. 6,220 expression cerebral cortex, 221 expression volumes, 222 expression somathetic areas, 223 expression thalamuses, 224 expression hypothalamuss, 225 expression limbic systems, the periaqueductal grey matter of 226 expressions, 227 expression network structure, 228 expression lateral spinothalamic tracts, 229 expressions are with surveying bundle (ipsilateral tracts), 230 expression substantia gelatinosa [of Rolandos, 231 expression cornu dorsales, the peripheral nociceptor of 232 expressions, and the main afferent neuron (A-delta﹠amp of 233 expressions; C).

C pain beat take place pain beat (pain impulse) (being the muscle twitches of action potential) can occur in nerve ending (being the pain receptive field) or along a certain position of pain pathways.What cause the afferent neuron cell wall repeats central nervous system's the muscle twitches of action potential that will cause leading of unpolarized any stimulation or wound.

The interrupt method that II pain is beaten

The A electricity irritation. attempting to control violent and adopting various electrical stimulation methods during long-term pain.Various theories mainly comprise: 1) gate theory (Gate Control Theory), and 2) stop disengaging of endorphins that pain propagates.The gate theory is the most well accepted.Because thereby the reduction of the usefulness of the C fibrid of the common activation input of mechanical stimulus susceptibility category-A fiber increases the ratio of category-A fiber/C fibrid is principle mechanism.Net result is to increase the frequency of category-A fiber excitation to the excitation of C fibrid.The final minimizing that this nociception that causes entering the central nervous system is beaten.Mechanical stimulus susceptibility category-A fiber is activated under lower intensity of electric stimulus than C fibrid, and promptly the category-A fiber has low threshold value.Therefore, can under the situation of the incentive rate that does not increase the C fibrid, utilize more low intensive electricity irritation optionally to activate mechanical stimulus susceptibility category-A fiber.When stimulus intensity increases, can activate mechanical stimulus susceptibility and nociception fiber.This has reduced the ratio of category-A fiber to the excitation of C fibrid, and when stimulus intensity increased, patient experienced more pain rather than lighter, and this is because the C fibrid activates and the reduction of the excitation ratio of category-A fiber/C fibrid.In some cases, can not be under enough low intensity reach and ease the pain by optionally activating the category-A fiber.In these cases, may increase along with stimulus intensity increases pain, TENS lost efficacy in other words.

We are verified, and the nociception that mechanism of the present invention comprises prevention C fibrid is input to the central nervous system.We utilize capsaicin model (model) and prove that this experimental provision stops indirect hyperesthesia of C fibrid and hyperpathia (seeing Fig. 8 to 14).Fig. 8 shows the situation of change that the dose response (dose response) of hyperpathia that capsaicin causes and hypersensitive area increases along with electric current density.Hyperesthesia and hyperalgesic area with centimetre ²Expression, intensity is by owing threshold value, threshold value and crossing threshold value (face as follows) expression.The label of 60M is meant to stimulate 60 minutes.Variation when Fig. 9 is illustrated in lasting 15 minutes, 30 minutes, 60 minutes of threshold current and continues 5 minutes under crossing threshold value aspect surface hyperpathia and the hyperesthesia.If with reference to Fig. 8 or 9, the remainder of each figure is a self-explanatory.

In Fig. 8, the tape at 301 places is shown in the hyperesthesia of first object and hyperpathia (being respectively 204.5 and 66.16 square centimeters) after 60 minutes under the intensity I of owing threshold value, and the tape at 302 places is shown in hyperesthesia and the hyperpathia (being respectively 141.35 and 15.03 square centimeters) after 60 minutes under the intensity I of threshold value, and the tape at 303 places was shown in hyperesthesia and the hyperpathia (being respectively 52.6 and 2.25 square centimeters) after 60 minutes under the intensity I of threshold value.

In Fig. 9, the tape at 401 places is shown in the hyperesthesia and the hyperpathia (being respectively 82.7 and 1.5 square centimeters) of the left arm of first object after 15 minutes under the intensity of threshold value, and the tape at 402 places is shown in hyperesthesia after 30 minutes and hyperpathia (being respectively 110.5 and 7.51 square centimeters) under that intensity, the tape at 403 places is shown in hyperesthesia after 60 minutes and hyperpathia (being respectively 141.35 and 15.03 square centimeters) under that intensity, and the tape at 404 places was shown in hyperesthesia and the hyperpathia (being respectively 52.6 and 2.25 square centimeters) after 5 minutes under the intensity of threshold value.

In Figure 10, the tape at 501 places is shown in the hyperesthesia and the hyperpathia (being respectively 135.3 and 33.08 square centimeters) of the right arm of second object after 15 minutes under the intensity of threshold value, and the tape at 502 places is shown in hyperesthesia after 30 minutes and hyperpathia (being respectively 153.3 and 55.6 square centimeters) under that intensity, the tape at 503 places is shown in hyperesthesia after 60 minutes and hyperpathia (being respectively 113.5 and 29.3 square centimeters) under that intensity, the tape at 504 places was shown in hyperesthesia and the hyperpathia (being respectively 122.5 and 2.78 square centimeters) after 5 minutes under the intensity of threshold value, the tape at 505 places is illustrated in TENS and closes hyperesthesia and hyperpathia (being respectively 67.66 and 12.03 square centimeters) after 5 minutes, the tape at 506 places represents to use Magna Bloc to be installed on hyperesthesia and the hyperpathia (being respectively 0 and 0 square centimeter) after 5 minutes under the intensity of threshold value, and hyperesthesia and the hyperpathia (be respectively 60.9 and 6.76 square centimeter) of the tape at 507 places after being illustrated in TENS and Magna Bloc device and closing.

In Figure 11, the tape at 601 places is shown in the hyperesthesia of the left arm of second object and hyperpathia (being respectively 91.7 and 27.8 square centimeters) after 15 minutes under the intensity of owing threshold value, and the tape at 602 places is shown in hyperesthesia after 30 minutes and hyperpathia (being respectively 93.2 and 41.4 square centimeters) under that intensity, the tape at 603 places is shown in hyperesthesia after 60 minutes and hyperpathia (being respectively 106.7 and 48.9 square centimeters) under that intensity, the tape at 604 places was shown in hyperesthesia and the hyperpathia (being respectively 0 and 5.3 square centimeter) after 5 minutes under the intensity of threshold value, the tape at 605 places represents to use Magna Bloc to be installed on hyperesthesia and the hyperpathia (being respectively 0 and 0 square centimeter) after 5 minutes under the intensity of threshold value, the tape at 606 places is illustrated in TENS and Magna Bloc device after closing hyperesthesia and hyperpathia (being respectively 0 and 21.1 square centimeter).

In Figure 12, the tape at 701 places is shown in the hyperesthesia and the hyperpathia (being respectively 36.09 and 2.25 square centimeters) of the right arm of the 3rd object after 15 minutes under the intensity of threshold value, and the tape at 702 places is shown in hyperesthesia after 30 minutes and hyperpathia (being respectively 54.88 and 10.9 square centimeters) under that intensity, the tape at 703 places is shown in hyperesthesia after 60 minutes and hyperpathia (being respectively 33.83 and 1.87 square centimeters) under that intensity, the tape at 704 places was shown in hyperesthesia and the hyperpathia (being respectively 0 and 0 square centimeter) after 5 minutes under the intensity of threshold value, the tape at 705 places represents to use hyperesthesia and the hyperpathia (be respectively 0 and 0 square centimeter) of Magna Bloc device after 5 minutes, the tape at 706 places is illustrated in Magna Bloc device and closes hyperesthesia and hyperpathia (being respectively 1.87 and 0 square centimeters) after 5 minutes, and the tape at 707 places is illustrated in TENS and closes hyperesthesia and hyperpathia (being respectively 1.87 and 0 square centimeters) after 5 minutes.

In Figure 13, the tape at 801 places is shown in the hyperesthesia of the left arm of the 3rd object and hyperpathia (being respectively 42.1 and 9.77 square centimeters) after 15 minutes under the intensity of owing threshold value, and the tape at 802 places is shown in hyperesthesia after 30 minutes and hyperpathia (being respectively 23.3 and 2.25 square centimeters) under that intensity, the tape at 803 places is shown in hyperesthesia after 60 minutes and hyperpathia (being respectively 42.8 and 4.51 square centimeters) under that intensity, the tape at 804 places was shown in hyperesthesia and the hyperpathia (being respectively 0.75 and 0 square centimeter) after 5 minutes under the intensity of threshold value, the tape at 805 places represents to use Magna Bloc to be installed on hyperesthesia and the hyperpathia (being respectively 0 and 0 square centimeter) after 5 minutes under the intensity of threshold value, the tape at 806 places is illustrated in the MagnaBloc device and closes hyperesthesia and hyperpathia (being respectively 0.75 and 0 square centimeter) after 5 minutes, and the tape at 807 places is illustrated in TENS and closes hyperesthesia and hyperpathia (being respectively 0.75 and 0 square centimeter) after 5 minutes.

Figure 14 is illustrated in and utilizes placebo and Magna Bloc ^TMThe treatment arm in the hyperalgesic assessment of 15 minutes (tape that has downward-sloping from right to left line), 30 minutes (tape that has vertical line), 60 (tape that has downward-sloping from left to right line) timesharing, the numeral 901 to 905 on right side is the object (901-901 identical with the left side, 902-902,903-903,904-904 and 905-905), but be the opposite arm of using placebo treatment.Vertical axis is represented the hyperpathia of being brought out by capsaicin with square centimeter (H-CM2) metering.

We prove that also the effect that stops the propagation of C fibrid is with relevant in the electric current density that afflicted areas takes place.We make this device more effective by changing the electrode design structure, and verified, and gate mechanism is consistent with our discovery.

Nociception C fibrid is normally immobilized.Yet, the tissue injury sexual stimulus is activated the free nerve ending that is embedded in Intradermal.This transduction step relates to injects calcium to form generator potential.In case generator potential reaches threshold value, action potential excitation and along the C fibrid to the centre pilot spinal cord.According to the gate theory of pain, last result is that the stimulation of C fibrid changes the category-A fiber to the activated ratio of C fibrid, and this has increased the incentive rate (firing rate) of T cell conversely, and causes pain perception.Pain intensity becomes ratio with the incentive rate of T cell.Show that the present invention has reduced the incentive rate of C fibrid under two kinds of situations in teat glass and body.The change of the ratio of category-A fiber/C fibrid incentive rate causes pain relief.

B.Magna Bloc ^TMTMNS. show, in vitro and in vivo MagnaBloc under two kinds of situations ^TMAll reduced the incentive rate of C fibrid.The change of the ratio of category-A fiber/C fibrid incentive rate eases the pain to produce the identical mode of pain relief with TENS.

Magna Bloc ^TMTo in volunteers, utilizing the effect of the C fibrid that capsaicin stimulates

Foreword

This report is summed up and has been summarized my analysis in March, 1991 collected data in clinical research, and whether the therapy equipment that clinical research is intended to test the application is for the people's that uses this device arm effective in cure (seeing Figure 14).Test is and Joes Ochoa, MD., and phD., DS.C is at Good SamaritanHospital and medical Center in Portland, and Oregon carries out.Dr.Ochoa is the director of thePeripheral Nerve Disease at Unit Good Samaritan Hospital and Medical Center.

1 pair of five tested object carries out clinical research.Twice of two tested object test wherein.Tested object the range of age is 37 to 50.Two to as if the women, three is the male.Each tested object is all in good health.The neither one tested object is taken medicine.

2 by the testing research person and the test assistant test.Each tested object is once used " reality " magnetic therapeutic apparatus (Magna Bloc ^TM) test." reality " therapy equipment of using in test has the magnet of 4 1/2 inch diameters, and each magnet has the magnetic energy product (magnetic energyproduct) of 27MG-Oe, all is encapsulated in the plastic opaque housing.Each tested object also uses " comfort " device to test.The look and feel that is somebody's turn to do " comfort " device is all identical with " reality " device, in this comfort device, is to utilize 4 magnets of 4 nonmagnetic metal posts replacements just.Order actual or the comfort test is selected by random fashion by the upthrow coin.What tested object and testing research personnel did not know a concrete test usefulness is actual device or comfort device.

3 each tested object with actual magnetic therapy equipment test, are tested with the comfort device on another arm on an arm.Arm distributes (being that right arm is done earlier or left arm is done earlier) to be determined at random by the upthrow coin.

4 follow following operation sequence to each test, no matter be right arm or left arm, no matter treatment is to utilize actual or comfort.

The A injection point is selected on the palmar side forearm of tested object, upwards 17.5 inches apart from tester's wrist along arm.Injection point ink dot labelling.With therapy equipment (actual or contrast) fixed in above the injection point of tested object arm and reclined on it 15 minutes.After 15 minutes, the forearm of therapy equipment from tested object taken off, and at the injection point place capsaicin of one micrograms dose is expelled to (subcutaneous) in tester's arm (a bit test object is reactionless to the capsaicin of a micrograms dose, has therefore injected the capsaicin of 5 micrograms dose).Capsaicin is the pungent active component in the pungent Fructus Capsici.Have been found that the stimulation with pain in the capsaicin energy human activin is transferred to central nervous system's C class nociception nerve fiber.

B is right after after the injection, and therapy equipment is put back on the capsaicin injection point., will take off in short-term on the arm of therapy equipment by tested object after back 15 minutes in injection, so that measure skin hyperpathia area (skin pain that causes with the slight striking of cotton swab).Then this measurement is put back to therapy equipment on injection point immediately.The hyperalgesic operation sequence of 30 timesharing repeated measure skins after injection.

C back 60 minutes in injection takes off the arm of therapy equipment by tested object, measures the hyperalgesic area of skin for the third time.The hyperpathia area is measured in 15,30 and 60 timesharing after the injection capsaicin.By not touching the area that skin is determined hyperalgesia can not cause the mode of pain perception usually with cotton swab.The described area that causes tested object pain that touches around injection point is found out and is tested with square centimeter.The hyperpathia area measurement result of tested object is illustrated in (hyperalgesic area) in the table.

5Robert A.Parker is a biomedical statistics man, and he is by the data of engaging analysis to be obtained by above-mentioned clinical research.Mr.Parker obtained the mathematics bachelor in science degree of the Massachusetts Institute of Technology in 1970; Obtained the treatment statistics Master of Science degree of the London School of Hygiene and tropical Medicine in 1976; Nineteen eighty-three is obtained biostatistics's Ph.D.degree of the Harvard School of Public Health.Mr.Parker is the associate professor of the Vanderbilt University School of Medicine at present.

6Mr.Parker find, in 15,30 and 60 timesharing concerning the measurement of hyperpathia area, the difference of aspect as a result between the actual and comfort property treatment has statistical importance.

TENS (through the skin electro-neural stimulator instrument) is to by the C that stimulated with capsaicin in volunteers

Hyperesthesia that fibrid is regulated and hyperalgesic effect

This report is summed up and has been summarized me at the Department of Neurology, the analysis (seeing Fig. 8-13) of the data that VanderbiltUniversity Medical Center in Nashville, Tennessee collected in nineteen ninety-five.Research to human body is intended to test TENS device and Magna Bloc ^TMWhether device suppresses or interrupts nociceptor (C fibrid) excitation in the human body pain model, subcutaneous injection 1 microgram capsaicin and assess hyperpathia and hypersensitive area according to the time in the human body pain model.Purpose be the assessment effect be equal to mechanism substantially.

1 two arms that are used to study 3 tested object utilizations carry out clinical research.Variable is time, electric current density and TENS and Magna Bloc ^TMCombination.Tested object the range of age is 28 to 60 years old.All tested objects are the male; In good health.The neither one object was once taken medicine.

2 by the testing research personnel and the test assistant test.We use has the EPIX XL of 4 stimulations with electrode ^TMThe TENS device.4 electrodes of TENS device are placed on one 5 centimetres of quadrate each angles.The polarity of each electrode is: opposite with the electrode on the adjacent angle, and identical with the polarity of electrode on the diagonal angle.Each tested object is once tested to owe threshold densities with TENS on an arm, tests with super threshold values density subsequently with threshold densities with TENS on another arm.Owe the threshold value magnitude and be defined as, be defined as by the uncomfortable but maximal density of pain not of being described as of can bear of object and cross the threshold value magnitude by the sensitive minimum density of object.

3 follow following operation sequence for each test:

A. injection point is selected on the palmar side surface of tested object forearm, upwards 17.5 inches apart from tester's wrist along arm.With therapy equipment fixed in last 15 minute of injection point of tested object arm.After 15 minutes, inject the capsaicin of 1 micrograms dose to the arm (subcutaneous) of object at this injection point place.Capsaicin is the pungent active component in the pungent Fructus Capsici.Found that capsaicin can activate in the intravital C class of people nociception nerve fiber, causes pain and secondary hyperpathia by the multisynaptic reflex that pain stimulation is transmitted to the central nervous system.

B was injection after the

capsaicin

15,30 and 60 minutes and utilizing Magna Bloc ^TMCarrying out threshold value stimulated back 5 minutes, measured the area of hyperesthesia (touching initiation by what the waddy with cotton swab slipped over that skin causes) and hyperpathia (slipping over the skin pain that touches initiation that skin causes by the waddy with cotton swab).Utilize line of ink marker labelling hyperesthesia and hyperalgesic area and measure by square centimeter.

The capsaicin model

Capsaicin is pungent piperic " pungent " or " activity " part.The multidigit research worker is verified, and when pressing subcutaneous injection, capsaicin only activates polymorphic importing into (C fibrid) nociceptor.Therefore, the C fibrid that imports the central nervous system into is beaten and is experienced as pain.This C fibrid activates stimulates spinal reflex, and spinal reflex stimulates the orthosympathetic C fibrid nervus centrifugalis in the capsaicin injection zone.C fibrid nervus centrifugalis exceedingly makes skin sensitivity.The result is the extrasensitivity that makes the skin that causes pain perception when touching.It is relevant that hyperesthesia and hyperalgesic area and C fibrid import incentive rate into.So by utilizing this model, the conduction that just can assess the therapeutic effect when stimulating and beat by the pain that polymorphic nociceptor is regulated.

This device is selected to be used for stimulating the category-A fiber and to suppress the symmetric electric current density of C fibrid and can obtain uniform effect to pain therapy basically owing to producing.

Claims

1. electronic therapy device, the electricity irritation and the specific Meissner oscillator that are used for applying by the body surface to animal suitable electric current density stimulate the pain for the treatment of the people, comprising:

In the combination electrode that comprises four electrodes, four electrodes two are that anelectrode, two are negative electrodes, and described each electrode limits tetragonal relatively to angular vertex,

One attachment device, four electrodes and the human body that are used for fixing described device keep in touch, wherein

Each electrode by means of power triggering and to produce electricity irritation, and

Each electronic pads comprises a Magna Bloc ^TM, it is in place that it utilizes an aluminum button to fasten.

2. electronic therapy device as claimed in claim 1, wherein, described combination electrode disposes to allow to form isolated each electronic pads of distance of suitable electric current density in stimulated zone.

3. electronic therapy device as claimed in claim 2, wherein, combination electrode is contained in the single connecting device, and this device comprises and is used for fixing the attachment device that each electrode and human body keep in touch.

4. electronic therapy device as claimed in claim 3, wherein, each fixes a quadrupole Meissner oscillator, the activity that is used to modulate the C fibrid described four electrodes of combination electrode.

5. electronic therapy device as claimed in claim 4, wherein, described quadrupole Meissner oscillator produces greater than 45 ° and forms less than pack into the neodymium magnetic pole of (center charged) of the circular central of 90 ° three-dimensional flux field gradient by four alternating polarities and along " Z " axle.

6. electronic therapy device as claimed in claim 5, wherein, described quadrupole Meissner oscillator suppresses the excitation of C fibrid, thereby thereby forms favourable A-delta/C fibrid excitation than also more effectively stoping periphery to produce pain.

7. electronic therapy device as claimed in claim 6, wherein, this combination electrode is made up of four electrodes, and wherein two are anodal, and two be negative pole in addition, and all electrodes are that qualification is tetragonal relatively to the electrode of angular vertex.

8. electronic therapy device as claimed in claim 7, wherein, Meissner oscillator comprises four and remains in the plastics accommodating device and form the identical magnetic pole of 60 ° to 70 ° flux field gradient along the Z axle, and this device is fixed each magnet with the configuration of expecting.

9. electronic therapy device as claimed in claim 8, wherein, the flux field gradient is to be calculated by the slope of magnetic field intensity with variable in distance.

10. electronic therapy device as claimed in claim 9, wherein, this system among being in the pain syndrome for the treatment of the category-A fiber and the zone of C fibrid between each electrode, keep certain current density or electric current in a continuous manner.

11. electronic therapy device as claimed in claim 10, wherein, utilization is kept required electric current density by each electronic pads of a scope monitor and warning system control, and this warning system receives the detection input from the voltage detector on the skin that is configured in the treatment region.

12. electronic therapy device as claimed in claim 11, wherein, electric current changed once between four electrodes in per two seconds.

13. electronic therapy device as claimed in claim 12, wherein, because Magna Bloc ^TMBe arranged in the electrode, electric current can be operated on higher level than traditional TENS device.

14. electronic therapy device as claimed in claim 13, wherein, Meissner oscillator stops the excitation of C fibrid, therefore forms the useful balance of category-A fiber/C fibrid excitation ratio.

15. electronic therapy device as claimed in claim 14, wherein, described generation and control device comprise a TENS generating apparatus, this device comprises battery, pulse generator, intensity controller, frequency controller, the persistent period controller, electric current density modulation and polarity conversion equipment and the arrangements of electric connection that is used for all these functions.

16. electronic therapy device as claimed in claim 1, wherein, described Meissner oscillator alleviates the uncomfortable of C fibrid excitation fully and makes unlikely the surpassing of threshold value of C fibrid.