WO2005023362A1

WO2005023362A1 - Electrostimulation device and method

Info

Publication number: WO2005023362A1
Application number: PCT/EP2003/009987
Authority: WO
Inventors: Enrico Jones
Original assignee: R.I.S.E. Ltd
Priority date: 2003-09-09
Filing date: 2003-09-09
Publication date: 2005-03-17
Also published as: AU2003260499A1; EP1663387A1

Abstract

The electrostimulation device (1) comprises acquisition means (2) for data (A, B, C) relative to a subject to be treated, connected to data (A, B, C) processing means (3) arranged to generate signals (4, 5) for controlling means for stimulating the subject to be treated. The processing means (3) are arranged to process the data (A, B, C) on the basis of several auricular charts (M) indicative of those points of the body on which to act to treat a given disturbance, in such a manner as to treat simultaneously and synergically several disturbances of a subject. The electrostimulation method consists of acquiring data relative to the subject to be treated and processing the data to generate control signals indicative of a stimulus to be applied to the subject to be treated.

Description

ELECTROSTIMULATION DEVICE AND METHOD

The present invention relates to an electrostimulation device and method.

In particular, the device and method of the invention are able to combat the smoking habit and, together with this, other secondary disturbances caused or not caused by the smoking habit, to generate an overall personal well-being.

In other cases, the device and method of the invention can also be used to combat other bad habits or for other purposes.

The ancient known science of reflexology has been studied and applied by the Chinese since 2000 B.C.; according to this science every body organ presents a reflex in other parts of the body, for example in the feet, nose, ears, etc.

A branch of reflexology known as auricolotherapy studies the effects on the body of stimuli applied to the ears.

According to this science, benefits for the human body can be obtained by stimulating suitable points of the ears; in particular it has been found that a suitable stimulation can limit or interrupt the smoking habit, and in other cases can aid the struggle against stress, migraine, etc.

Traditionally these stimuli were applied by acupuncture, however it is evident that only a considerable experience could enable positive results to be obtained on a subject, and that not all subjects were disposed to undergo acupuncture treatment; this has considerably limited the spread of auricolotherapy in overcoming the smoking habit or for other purposes.

It was subsequently found that positive effects could also be obtained on subjects by stimulating the ear with direct current electrical pulses of low intensity, with the result that machines have been developed for overcoming smoking by electrically stimulating the ear (in accordance with the teachings of auricolotherapy).

However these machines have proved hardly effective as they are able to generate signals of which only the intensity can be modulated, hence the applied pulse is generic and is not aimed to the individual patient, with the direct consequence of very poor results from the transmissions effected by such a machine. Moreover the traditional machine does not enable account to be taken of preceding treatments of similar cases; this is evidently an extremely serious drawback because each treatment must commence from the same starting point without the possibility of automatically regulating the machine at the commencement of treatment. The consequence of this is that the treatment time is always very long.

Even when a positive result with temporary interruption of the smoking habit is obtained with traditional machines, it has been found that in numerous cases there is a relapse as a result of side effects which the machine is unable to treat; for example, treatment might interrupt the smoking habit, however this could cause a stress increase in the subject, who might then (as often happens) resume smoking to overcome the stress.

The technical aim of the present invention is therefore to provide an electrostimulation device and method which enables the technical drawbacks of the known art to be eliminated. Within the scope of this technical aim, an object of the invention is to provide an electrostimulation device and method which enable a subject to be stimulated by electrical pulses, the points of application and characteristics of which are personalized for the individual subject. Another object of the invention is to provide an electrostimulation device and method, the effectiveness of which improves with time by virtue of a sophisticated system of self-learning which, as the number of treatments increases, enables patients to be treated with electrical pulses having characteristics similar to those of other patients with substantially the same problem; in this manner the treatment becomes very rapid because from the commencement of treatment the pulses applied to the patient present characteristics very similar to those of maximum effectiveness for the treatment, consequently the number of sessions required to attain the purpose and terminate the treatment is very- small.

A further object of the invention is to provide an electrostimulation device and method which enable several bad habits and problems to be treated simultaneously in one subject, for example a subject can be treated for smoking and stress simultaneously. This characteristic of the device and method of the invention proves to be of considerable importance because if only smoking addiction was concerned, overcoming this would still leave a very high risk of relapse because of side effects, in particular stress. A further object of the invention is to provide a device which can be used not only as a stimulator (i.e. to stimulate a subject) but also as a sensor (i.e. to identify those points of the subject's ear which present best conductivity, and hence be subsequently used for application of the stimulation electrodes). The technical aim, together with the aforegoing and other objects, are attained by an electrostimulation device and method in accordance with the accompanying claims.

Further characteristics and advantages of the invention will be apparent from the description of a preferred but non-exclusive embodiment of the electrostimulation device and method according to the invention, illustrated by way of non-limiting example in the accompanying drawings, in which: Figure 1 shows a Nogier auricular chart indicating those ear points to be stimulated to overcome the smoking habit;

Figure 2 shows a block diagram of a device according to the present invention; Figure 3 shows a block diagram of a method according to the present invention; Figure 4 shows an outline software arrangement for implementing the method of the present invention; Figure 5 is an outline diagram showing the flow of information within the software implementing the method of the present invention; Figure 6 shows a block diagram of the electronic circuits of the device according to the invention when operating as a stimulator; Figure 7 shows a block diagram of the electronic circuits of the device according to the invention when operating as a sensor, Said figures, and in particular Figure 2, show an electrostimulation device indicated overall by the reference numeral 1.

The device 1 comprises acquisition means 2 for data A, B, C relative to a subject to be treated, connected to data processing means 3.

The processing means 3 are arranged to generate control signals 4, 5 for means 6 for stimulating the subject to be treated.

Advantageously the processing means 3 are arranged to process the acquired data on the basis of several auricular charts M (an auricular chart is shown for example in Figure 1) indicative of those points of the body on which to act to treat a given disturbance. Auricular charts are known and are obtainable from the literature; in particular, reference is made here to Nogier charts which have been developed using forty different models for a like number of pathologies or behavioural habits or simply disturbances of the person (stress, migraine, etc.).

Hence, in practice the auricular charts indicate those points of the ear which must be stimulated to overcome a determined personal habit or behaviour.

In this manner, by stimulating those points of the ear relative to several charts simultaneously, several disturbances of one and the same subject can be treated simultaneously. The control signals comprise first control signals 4 indicative of those ear positions to be stimulated and second control signals 5 indicative of the intensity (pli), the repetition frequency (pfv), the application time (atp), the symmetry (dcy) and the incremental intensity ramp (sli) of the stimulus to be applied to the subject. There are hence a total of six control signals. The device 1 comprises first storage means 7 for the acquired data and manual control means 8 for regulating one or more of the first and second control signals 4, 5 originating from the processing means 3, to generate third signals 9 indicative of the stimulus to be applied to the subject. Advantageously, the data A, B, C acquired and stored by the first storage means 7 relate to case-history data (A), quantitative indices (B) and qualitative indices (C). The case-history data relate to: age, sex, ethnic origin, collateral disturbances (for example stress), organic disturbances and pain. The quantitative indices B relate to: time of addiction to the habit (no. of years) and daily addiction (habit frequency). The qualitative indices C relate to the Fagerstrom tolerance test (physical addiction test). The Fagerstrom tolerance test is as follows:

The value C is given by the sum of the points relative to each reply to the questions of the Fagerstrom tolerance test. The first and second control signals 4, 5 are determined as follows. The first control signals 4 identify those ear points to be stimulated; these points consist of all those of the auricular charts M relative to the habits or disturbances to be overcome. For example if smoking and stress are to be overcome, two auricular charts M are used, each of which identifies those ear points to be stimulated.

The first signal 4 identifies as points to be stimulated all the stimulation points present in the smoking and stress charts. In contrast, the second signals 5 are identified as follows. A signal indicative of the stimulus intensity (pli) is calculated by the formula: pli (in μA) = dl*(1.95 + mps/15 + mcd/20) where dl equals 200 and is adjustable manually during treatment; mps is one of the acquired data items and corresponds to the average number of years of smoking; mps is another of the acquired data items and corresponds to the number of cigarettes smoked per day.

A signal indicative of the repetition frequency of the stimulus (pfv) is calculated by the formula: pfv (Hz) = df^*(0.75 + (5/fsd))*pli/10000 where df equals 10 (statistical return value from the preceding treatments); fsd is the result of the Fagerstrom test; pli is the previously calculated intensity.

A signal indicative of the application time for each point of the ear (atp) is calculated by the formula: atp (sec) = dt*fsd*pli/100 where dt equals 10, being a statistical return value from the preceding treatments, and is adjustable manually during the treatment; fsd is the result of the Fagerstrom test; pli is the previously calculated intensity.

A signal indicative of the stimulus symmetry (dcy) is calculated by the formula: dcy (%) = ddc*50/100 where ddc is a default value equal to 1 , being a statistical return value from the preceding treatments, and is adjustable manually during the treatment.

A signal indicative of the incremental intensity ramp (increment time for current pli) is calculated by the formula: sli (sec) = int(ds + 2^*atp/50) where ds is a default value equal to 2, being a statistical return value from the preceding treatments, and is adjustable manually during the treatment, atp is the previously calculated application time.

The device 1 also comprises second storage means 11 for storing the third signals 9.

As shown by the accompanying diagrams and in particular Figure 2, the device also comprises third storage means 12 for the successes S obtained during treatment, and communication means 14 for feeding to the processing means 3 at least one feedback signal indicative both of the successes obtained and of the third control signals 9.

Advantageously, the device comprises statistical processing means 15 for the third control signals 9 on the basis of the successes obtained during treatment, on the basis of the input data A, B, C and on the basis of the manual control signal.

In a preferred embodiment, the aforesaid means all consist of the circuits of one or more microprocessors operationally connected together. The device also comprises means 17 for connecting the subject to be treated to earth. The electrical stimulus is transmitted to the stimulation means 6 via a bidirectional communication device 16 which operates without connection to the electric mains.

Figure 6 shows the stimulation means 6. These comprise a regulator for automatically regulating the stimulation pulses on the basis of the skin conductivity characteristics.

The transmission system can be either of PWM type (pulse width modulation) or PAM type (pulse amplitude modulation) or PFM type (pulse frequency modulation).

The regulator 20 is connected to a circuit 21 comprising a digital potentiometer adjustable between 0-100% and a shunt 23 connected in parallel; the potentiometer 22 and shunt 24 are connected to a current regulator 24, to an error amplifier 25, and to a voltage generator of low power switching type, current-controlled from 0-1.2 mA by the regulator 20. The voltage generator 26 is connected to a branch 27 of the circuit extending between the shunt 23 and a static switch 28. The circuit 21 also comprises a pulse amplitude (current intensity), frequency and shape modulator 29, connected to the static switch 28. The potentiometer 22, the voltage generator 26 and the modulator 29 are all controlled by the regulator 20, which is preferably a microprocessor. The circuit 21 also comprises one or more stimulation electrodes 30 of known type to be applied to the ear (preferably two electrodes, one for each ear). Figure 6 also shows the element 17 duly connected to earth (this element constitutes the means for connection to earth); the element 17 must be held in the hand during treatment, in order to close the electrical circuit through the subject to be treated.

The operation of the device according to the invention is apparent from that described and illustrated, and is substantially as follows. A first example refers to a subject suffering for 20 years from the habit and smoking 20 cigarettes per day, to be treated for smoking and stress and presenting low addiction on the basis of the Fagerstrom test (=3).

The ear points to be stimulated are all those identified by the auricular chart relative to smoking (shown in Figure 1) and those of the auricular chart relative to stress (not shown but available in the literature).

The processed control signals relate to a current having: pli = 856.7 μA, pfv =

2.07 Hz, atp = 25.70 seconds, dcy = 0.5%, sli = 3 seconds.

A second example refers to a subject again suffering for 20 years from the habit and again smoking 20 cigarettes per day, to be treated for smoking and stress but presenting high addiction on the basis of the Fagerstrom test (=11).

The ear points to be stimulated are the same as those previously identified as they correspond to all those defined by the auricular chart relative to smoking

(shown in Figure 1) and those of the auricular chart relative to stress (not shown but available in the literature). The processed control signals relate to a current having: pli = 923.3 μA, pfv = 1.032 Hz, atp = 94.23 seconds, dcy = 0.5%, sli = 5 seconds.

These signals are transmitted to the stimulation means 6 which stimulate the subject's ears via the electrodes 30.

The device can operate not only as a stimulator, but also as a sensor for sensing the electrical impedance of the skin of the subject to be treated. In this case the regulator 20 is connected to a circuit presenting a branch 35 connected to a first input of the electrometric differential amplifier 36, which is connected to an analog/digital converter 37 connected to the regulator 20 to provide it with the measured impedance values.

A second circuit branch 38 comprises a biasing circuit 39 connected on one side to the regulator 20 and on the other side to an adder 40.

The adder processes the signals from an electrical impedance measuring device 41 and from the biasing circuit 39, to provide a resultant signal to a second input of the differential amplifier 36.

The measuring device 41 is connected to the sensors 30 applied to the ears; again in this case the subject holds the earth connection element 17 in the hand. With reference to Figure 3, the present invention also relates to an electrostimulation method which consists of acquiring in 50 the data relative to a subject to be treated, and processing the data in 51 to generate control signals indicative of a stimulus to be applied to the subject to be treated; the data are processed on the basis of several auricular charts M indicative of those points of the body on which to act to treat a given disturbance, in such a manner as to treat simultaneously and synergically several disturbances of a subject.

The control signals comprise first control signals 4 indicative of those ear positions to be stimulated, and second control signals 5 indicative of the intensity (pli), of the repetition frequency of the stimulus (pfv), of the application time (atp), of the symmetry (dcy) and of the incremental intensity ramp (sli) of the stimulus to be applied to the subject. Advantageously the acquired data are stored in 52.

One or more of the first and second control signals 4, 5 can be manually adjusted in 53 to generate third control signals 9 indicative of the stimulus to be applied to the subject; the third signals 9 are also stored in 54. The successes S obtained during the treatment are suitably stored in 55, this information being used, together with the third control signals 9, during the processing in 51 to regulate the first and second control signals 4, 5. The third control signals 9 are statistically processed on the basis of the successes, on the basis of the input data and on the basis of the manual control signal. The method is implemented by means of electrostimulation software by which input data is processed on the basis of several auricular charts indicative of those points of the body on which to act to treat a given disturbance, in order to generate a stimulus to be applied to the subject to be treated, in such a manner as to treat simultaneously and synergically several disturbances of a subject. It has been found in practice that the electrostimulation device and method of the invention are particularly advantageous as they enable very effective treatments to be achieved in a short time for more than one bad habit or problem of the subject, for example smoking and stress. The electrostimulation device and method conceived in this manner are susceptible to numerous modifications and variants, all falling within the scope of the inventive concept; moreover all details can be replaced by technically equivalent elements. In practice the materials used and the dimensions can be chosen at will according to requirements and to the state of the art.

Claims

CLAIMS 1. An electrostimulation device (1) characterised by comprising acquisition means (2) for data (A, B, C) relative to a subject to be treated, connected to data (A, B, C) processing means (3) arranged to generate signals (4, 5) for controlling means for stimulating the subject to be treated, said processing means (3) being arranged to process said data (A, B, C) on the basis of several auricular charts (M) indicative of those points of the body on which to act to treat a given disturbance, in such a manner as to treat simultaneously and synergically several disturbances of a subject.

2. An electrostimulation device (1) as claimed in the preceding claim, characterised in that said control signals (4, 5) comprise first control signals (4) indicative of those ear positions to be stimulated.

3. An electrostimulation device (1) as claimed in one or more of the preceding claims, characterised in that said control signals (4, 5) comprise second control signals (5) indicative of the intensity (pli), the repetition frequency (pfv), the application time (atp), the symmetry (dcy) and the incremental intensity ramp (sli) of the stimulus to be applied to the subject.

4. An electrostimulation device (1) as claimed in one or more of the preceding claims, characterised by comprising first storage means (7) for said data (A, B, C).

5. An electrostimulation device (1) as claimed in one or more of the preceding claims, characterised in that said data (A, B, C) stored by said first storage means (7) relate to case-history data (A), quantitative indices (B) and qualitative indices (C).

6. An electrostimulation device (1) as claimed in one or more of the preceding claims, characterised by comprising manual control means (8) for regulating one or more of said first (4) and second (5) control signals originating from said processing means (3), to generate third signals (9) indicative of the stimulus to be applied to the subject.

7. An electrostimulation device (1) as claimed in one or more of the preceding claims, characterised by comprising second storage means (11) for storing said third signals (9).

8. An electrostimulation device (1) as claimed in one or more of the preceding claims, characterised by comprising third storage means (12) for storing the successes (S) obtained during the treatment, and communication means (14) for feeding to said processing means (3) at least one feedback signal indicative of the successes (S) obtained, and of the third control signals (9).

9. An electrostimulation device (1) as claimed in one or more of the preceding claims, characterised by comprising statistical processing means (15) for said third control signals (9) on the basis of the successes (S) obtained during the treatment, on the basis of the input data (A, B, C) and on the basis of the manual control signal.

10. An electrostimulation device (1) as claimed in one or more of the preceding claims, characterised by comprising means (17) for connecting the subject to be treated to earth.

11. An electrostimulation method, characterised by consisting of acquiring data relative to a subject to be treated, and processing said data to generate control signals indicative of a stimulus to be applied to the subject to be treated, the data being processed on the basis of several auricular charts indicative of those points of the body on which to act to treat a given disturbance, in such a manner as to treat simultaneously and synergically several disturbances of a subject.

12. An electrostimulation method as claimed in the preceding claim, characterised in that said control signals comprise first control signals indicative of those ear positions to be stimulated.

13. An electrostimulation method as claimed in one or more of claims from 11 onwards, characterised in that said control signals comprise second control signals indicative of the intensity, the repetition frequency, the application time, the symmetry and the incremental intensity ramp of the stimulus to be applied to the subject.

14. An electrostimulation method as claimed in one or more of claims from 11 onwards, characterised by storing said acquired data.

15. An electrostimulation method as claimed in one or more of claims from 11 onwards, characterised by manually adjusting one or more of said first and second control signals to generate third signals indicative of the stimulus to be applied to the subject.

16. An electrostimulation method as claimed in one or more of claims from 11 onwards, characterised by storing said third signals.

17. An electrostimulation method as claimed in one or more of claims from 11 onwards, characterised by storing the successes obtained during the treatment and using this information, together with the third control signals, during processing to regulate the generated first signals indicative of the stimulus.

18. An electrostimulation method as claimed in one or more of claims from 11 onwards, characterised in that said third control signals are processed statistically on the basis of the successes, on the basis of the input data and on the basis of the manual control signal.

19. An electrostimulation method as claimed in one or more of claims from 11 onwards, characterised by storing said third control signals.

20. Electrostimulation software, by which input data is processed on the basis of several auricular charts indicative of those points of the body on which to act to treat a given disturbance in order to generate a stimulus to be applied to the subject to be treated, in such a manner as to generate signals indicative of the stimulus to be applied to the subject, to treat simultaneously and synergically several disturbances of a subject.

21. An electrostimulation device and method, all as substantially described, represented in the accompanying tables and drawings, and claimed.