WO2004011087A1

WO2004011087A1 - System designed to generate programmed sequences of stimuli resulting in controlled and persistent physiological responses in the body

Info

Publication number: WO2004011087A1
Application number: PCT/NL2003/000245
Authority: WO
Inventors: Mauro Pastori
Original assignee: Patents Exploitation Company B.V.
Priority date: 2002-07-29
Filing date: 2003-04-02
Publication date: 2004-02-05
Also published as: EP1526892A1; AU2003219618A1

Abstract

The present invention refers to a system which induces controlled and persistent functional responses of the immune, nervous, vascular and muscular systems particularly to a system for the electric stimulation of a patient and to the relative method for providing electric stimuli to a patient. In an embodiment the system for the electric stimulation of a patient comprises: at least two electrodes able to be applied on the body of said patient; means for generating electric pulses between said at least two electrodes; said electric pulses have amplitude, width and frequency of repetition selectively variable; characterized by further comprising: a control system of said means for generating electric pulses; said control system controls said means for generating electric pulses in order to feed, automatically according to a prefixed succession, to said at least two electrodes a sequence of said electric pulses having variable width and repetition frequency in the time, said sequence include a first type of pulse having an asymmetric shape. (Fig. 2)

Description

"System designed to generate programmed sequences of stimuli resulting in controlled and persistent physiological responses in the body."

*****

DESCRIPTION The present invention refers to a system which induces controlled and persistent functional responses of the immune, nervous, vascular and muscular systems particularly to a system for the electric stimulation of a patient and to the relative method for providing electric stimuli to a patient. The human organism has developed a complex regulatory system which involves hormonal, immune and nervous activities that have the fundamental assignment of maintaining the homeostasis, that is the internal equilibrium in rest and stress conditions. These systems, that interact between them, control the cardiovascular and respiratory systems and metabolism. For example the excessive hormones production due to the stress, such as the hydrocortisone and the norepinephrine excesses alters the vasal walls, increases the arterial pressure, modifies the metabolism and the immunological defenses therefore it is harmful to the organism.

The consequence of the stress is hypertension, arteriosclerosis, obesity, and diabetes. In fact, the hydrocortisone excess due to the stress carries to an increase of the visceral fat, insulin excess, resistance to insulin, dislipidemia,

-increase of immunological- substances.such.as. the pro-inflammatory interleuchines L 1 - L 6, TNF that modify the immune defences of the body.

The complex control system, able to react to the stress is placed in the brain (hypothalamus). This system controls the autonomic and the hypothalamus -pituitary- adrenal systems. The immunological system is influenced by the aforesaid systems and at the same time it influences their function.

Up today there are no pharmacological treatments for regulating stress diseases. Nevertheless the Applicant has discovered that the application of electric pulses with definite width, frequency and intensity may modify the response to the stress. h view of the state of the art described, it is object of the present invention to induce controlled functional responses in the autonomic and central nervous systems, in the muscular, and immune and vascular systems in order to reduce inflammation and to accelerate the recovery process and reduce the pain.

It is also object of the present invention to provide a system for the electric stimulation of a patient having a simple use without complicated preparation and reducing the possibility of errors that can cause serious problem to the patient.

According to the present invention, such object is achieved by means of a system for the electric stimulation of a patient comprising: at least two electrodes able to be applied on the body of said patient; means for generating electric pulses between said at least two electrodes; said electric pulses have amplitude, width and frequency of repetition selectively variable; characterized by further comprising: a control system of said means for generating electric pulses; said control system controls said means for generating electric pulses in order to feed, automatically according to a prefixed succession, to said at least two electrodes a sequence of said

'electric pulses-having variable width -and repetition frequency in- the time_? said sequence include a first type of pulse having an asymmetric shape.

According to the present invention, such object is also achieved by means of a method for providing electric stimuli to a patient comprising the phases of: choosing the body region where a therapy is to be applied by means of a tree structure; applying at least two electrodes on the body of said patient; generating electric pulses between said at least two electrodes; feeding to said at least two electrodes, automatically according to a prefixed succession, a sequence of said electric pulses having width and repetition frequency variable in the time. Thanks to the present invention administering trains of pulses having temporal width variable in the time and with different pulse shapes, allows the effect to be not short-lived but long lasting. Such effect is even increased by repeating pulses at variable frequencies. The long-lasting effects of the therapy seem due to a reset of the immunological and neuro-endocrine functions, which means that a new equilibrium is reached. For example vasal obstruction caused by arteriosclerosis induces an ischemic stress, the administration of precise frequencies of pulses re-establish a normal microcircle function, the pain and the cutaneous lesions regress and general conditions of the patient improve. As the administration of stimuli is able to control haemorrahage this suggests that the sequences action is not due to a simple increase or decz-ease of the local flow, but, to a reset of the central regulating systems.

Selecting the wanted therapy by means of a tree scheme on the computer it allows to simplifying the application procedure. A further simplifying of the procedure and reduction of errors is obtained thanks to the showing of the electrode connection points on the computer.

The features and the advantages of the present invention will be made more evident by the following detailed description of a particular embodiment, illustrated as a non-limiting example in the aimexed drawings,

-wherein:

Figure 1 shows a system for the electric stimulation of a patient according to the present invention;

Figure 2 shows a block scheme of the electronic circuits of a system for the electric stimulation of a patient according to the present invention;

Figures 3 a, 3b and 3 c show some waveforms of electric pulses according to the present invention;

Figure 4 shows a graph of the amplitude of a signal picked on the palm of the hand, at the varying of the time before the application of abase sequence; Figure 5 shows a graph of the spectral power of the signal of figure 4;

Figure 6 shows a graph of the spectral power of a signal picked on the palm of the hand after the application of a base sequence.

All the results described are reached because the apparatus object of the present invention is able to send sequences of selective and specific pulses to nerves, vessels, muscles and immune system.

At the same time the present invention reaches a new equilibrium of the neuro-immune-endocrine functions which allows the therapeutic effect to be persistent. The electric and/or magnetic stimulation of the nervous system "in vivo" activates the nervous functions. Such activation may be performed in any central or peripheral area of the body.

Functional nerve activation occurs only when the following conditions are met: a) currents superior to excitation threshold should be applied for the various topographical districts and subject to wide variations, as related to prior functional activity; b) specificity of the functional response in relation to the size of the stimulated area, to the functional specialisation of the stimulated area, to the direction of the stimulus, to the anatomical connections of the stimulated nervous-area, the latter condition must take into account the general, properties of the pulse propagation through the nervous fibres and the synapses; c) relationship between the stimulus characteristics (width, intensity, frequency, shape of the pulse) and the conditions of the nervous tissue at the moment of the stimulation.

The exploitation of these properties in the last 70 years has permitted to improve the techniques of both clinical and experimental nervous system investigations arousing many physiological questions and demonstrating functional changes in human pathology. The idea of using the nervous system for inducing functional responses with a therapeutic purpose has given place to different approaches, which go from the electro- convulsive therapy in psychiatric contexts, to the electric stimulation of the nervous peripheral system with healing purpose (recovery of the muscular trophism and of the segmentary strength after nerve damage), to the insertion of stereotactics stimulators in proximity of specific neuronal circuits for activating or inhibiting sourcing of noise (for instance the electro stimulation of basal ganglia for extrapyrarnidal disorders and vagal nerve stimulation for epilepsy). Many of these applications are no longer experimental but are becoming standard therapeutic practices.

One major functional component of the nervous system is the so-called autonomic, or vegetative. Its knowledge is exponentially growing from its initial simple conception, based on Sherrington's reflex model, the physiology of the autonomous nervous system is today progressively invading other fields of medicine for its complexity and pervasivity; besides nervous regulation of the extracellular environment, inflammatory and immune response, local vasocostriction or dilatation, and other vital functions: oxygenation, nutrition and reproduction, the innervation of a complex multi-cellular system participates to co-ordination of the endocrine activity, to the processes of cellular differentiation, and in general to the

-adaptation of the organism to-life. -

Therefore, it is clear that the perspective of modulating the activity of the autonomic nervous system through direct stimulation, similarly to what is currently done with somatic nervous system, would open boundless possibilities in the therapy of many illnesses.

The present invention refers to a neuromuscular electric-stimulator based on frequency modulation which evokes electric potentials on tissue cell membranes.

The first general property on which this machine bases its function is that each excitable tissue (nerve or muscle) responds to electric stimulation according to an intensity-duration curve (I.D.).

The curve that derives is characteristic for each tissue: the higher is the tissue excitability, the more the I.D. curve shifts to the left. In the past these principles were used to evaluate the degree of muscle and nerve lesions. This property is extensible to all biological tissues, i.e. for every type of tissue exists an I.D. curve describing its response to electric stimulation.

For instance, to stimulate a nervous fibre, being the LD curve shifted to the left, the adequate stimulus has short duration, while, at equal intensity, a smooth muscle will be stimulated for a longer duration to obtain the same response. Less excitable tissues, like the connective tissue, will be elicited at higher intensity and longer duration.

The second general property is that a weak stimulus evokes a low membrane potential stimulation while the same stimulus repeated frequently become more intense due to a temporal summation of membrane potential. Also the second property of excitable tissues physiology (nerve and muscle), can be extended, as a general property, to all biological membranes.

The combination of the two properties allows substituting in the I.D. scale, intensity values with frequency values. In this way curves of frequency-duration (F.D.) similar to those of intensity- duration (I.D.) can be obtained. -

Another important property of this machine is the information system used, consisting in sequences of high fidelity synchronised digital signals selected for their action on major functional component of the autonomic nervous system.

Autonomic activity may be measured through the analysis of spectra obtained from recording heart beat, blood pressure, galvanic skin response, pupillar motility in response to postural change, psycho-physical stress, pain, etc.). Other methods to evaluate the autonomic system comprise: sympatho- cutaneous reflexes, gastro-intestinal motility recording, urine bladder motility, the analysis of micro-circle with laser-doppler flow and of the late cortical potentials after laser stimulation.

Despite of many methods do not enjoy wide standardisation, their combined use allows to quantitatively and reliably assess autonomic system functions, without considering that the microneurography, even if expensive and relatively invasive, allows the direct recording of the peripheral electric activity related to autonomic functions.

Now with reference to the figure 1, that shows a system for. the electric stimulation of a patient in accordance to the present invention, it is possible to note a computer 1 preferably portable, composed of a body having a keyboard 2, a screen 3, and means for the movement of the cursor 4. To the computer 1 is associated a container 5 that contains the circuits devoted to the generation of the electric pulses.

The container 5 comprises a lamp or led 6 indicating that the therapy is in course, a lamp or led 7 indicating that the therapy is over; a knob 8 for increasing or decreasing the value of the intensity of the pulses; a starting button 9 of the therapy, a stopping button 10 of the therapy, and a button 11 for interrupting the sound of a buzzer 12 which is used to indicate the stopping of the therapy. The container 5 also comprises a tap 13 for the connection of a controlling device comprising the commands for a remote control system, one or more exit taps 14 able to connect the electrodes to the system, and a connector 15, preferably of the S 232 type to allow the connection of the circuits placed in the container 5 to the computer 1. Now with reference to the figure 2, that shows a bock scheme of the electronic circuits of a system for the electric stimulation of a patient according to the present invention it is possible to note the computer 1 connected through an interface 21 preferably serial of the RS 232 type, to a microprocessor (CPU) 22. The microprocessor 22 is preferably of the type Z180. To the microprocessor (CPU) 22 is connected to a RAM memory 23 of 32Kb, to a FLASH memory 24 of 128 Kb, to a digital analogical converter (D/A) 25, to a timer circuit 26, and to a circuit of input/output 27.

The digital analogical converter (D/A) 25 and the timer circuit 26 are connected, in turn, to a pulse generator 28, which furnishes the pulses to the terminals 30, that are, in turn connected, to the exit taps 14. An oscillator 29 is connected to the pulse generator 28.

The lamp 6, the lamp 7, the knob 8, the buttons 9, 10, 11, and the buzzer 12 are connected to the input/output circuit 27. The knob 8 could be alternatively replaced with two buttons, one for incrementing the amplitude of the pulse and one for decrementing the amplitude of the pulse.

The microprocessor 22 receives from the computer 1 the sequence of the therapy that must perform and the abilitation to the therapy execution. It sends to the computer 1 an indication if the therapy is in course or in stand by, the remaining time and the number of the phase in course, the time remained for the completion of the therapy, the present value of the intensity of the pulses, and an indication if the therapy is over.

The microprocessor 22 interfaces and interacts with the other circuits by means of an internal bus. The FLASH memory 24 contains the program code for the management of the circuits and for the execution of the selected therapy. The RAM memory 23 is that in use for the operations of the microprocessor 22- and it -will contain the parameters, of the selected therapy.

The timer circuit 26 generates the sequence of the pulses. For each phase of the therapy, it receives from the microprocessor 22 the parameters of the pulses that must be generated (kind of waveform, pulse timing, repetition frequency, and total duration of the train of pulses) and it provides them at logical digital level, coherently to the received parameters, toward the pulse generator 28. The pulses are sent out only during the phase in which the therapy is in course. At the end of a possible temporary interruption, the pulses will restart from the point of therapy interruption. The digital analogical converter (D/A) 25 generates the reference voltage for the intensity value of the pulse. This voltage could vary between 0 and 3.6 Vdc and it is used for generating the amplitude voltage of the pulse. It could be increased or decreased at pleasure through the nob 8, only during the phase of therapy in course. At the beginning of the therapy, this voltage always starts from 0 Vdc and is brought again to this value at the end of the therapy and to the request of a temporary interruption. At the restart the voltage of the therapy could be brought again to the wanted value always through the knob 8.

The oscillator 29 generates a fixed frequency signal that is used as base synchronism for the generation of the pulses.

The pulse generator 28 generates the pulses to be sent to the patient. The amplitude of the voltage of the pulses comes from the digital analogical converter (D/A) 25.

The therapy is selected on the computer 1 following driven tree schemes. The therapy previously chosen is started through the starting button of the therapy 9. The operator will have the possibility of regulating the amplitude of the pulses and of suspending the therapy temporarily. The apparatus is connected to the patient through one or two cables ending each with two button clips. The clips are connected to two adhesive electrodes to be set on the body of the patient in opportune points.

The patient will have the -possibility of verifying on the screen 3 the type of therapy in course, the remaining minutes for the completion of the therapy, and the value of the amplitude of the pulses.

On the computer 1 are stored all the names and the references of the scheduled therapies, the sequences of the scheduled therapies, all the instructions and the messages for performing the therapies, and all the figures of the human body showing the connection points of the electrodes to the patient for the execution of the scheduled therapies. The human body is composed of two figures in which is seen from before, and behind. On the figures are indicated by red and black flashing points the points where connect the electrodes. The sequences of the scheduled therapies are stored on the computer 1, in the form of tables comprising, for each phase of the therapy, the pulse kind, the pulse timing, the repetition frequency and the duration of the phase. From the keyboard 2 it is possible to interrogate the computer 1 to get the instructions how to operate on the apparatus, how to connect the patient to the apparatus, how to choose the therapy, and how to get information on the developing out of the therapy.

In particular, at the turn on of the computer 1, a menu with a list of the main body regions (for example spine, leg, arm, etc.) where is possible to apply a therapy is showed in a window. Chosen one body region, a sub menu with a detailed list of the part of said body region (for example cervical spine, lumbar spine) will be shown. Chosen the interested part of the body, a further sub menu with a list of different kind of therapy, (for example back injury, left and right chronic contracture, trapezium contracture, chronic pain with parestesia) will be shown. On another window, where different views of the human body are shown, the points where the electrodes must be applied are indicated. Then, pushing a button available on the computer the therapy is enabled. That is, the computer will load the table with the pulse sequence associated at the required therapy. On two window of the computer ^"the duration of the thefapy and the voltage intensity of the pulses will shown. The amplitude of the pulse should be regulated, through the knob 8, a little under the pain threshold of the patient. Placed the electrodes at the positions indicated on the computer, the therapy can start pressing the starting button 9.

On the window showing the duration of the therapy, the time will be decremented accordingly, until the time will be zero and the therapy will be finished.

We refer now to the figures 3 a, 3b and 3 c that show the preferable waveforms of single electric pulses according to the present invention. They are preferably negative pulse, of preset amplitude, having a trailing edge with a fall time TO, a width Tl in which the signal remains at the low level and a leading edge having a rise time T2. Such a pulse has a width, taken at 50 % of the trailing edge and at 50 % of the leading edge, equal to Ti. It is possible to note that the pulse of figure 3 c has a leading edge that changes slope. In this case there is a first slope of the leading edge for about the 70% of the whole edge and a second slope less steep than the first slope for the remaining (30%) of the leading edge. The width of the leading edge T2 is so divided in T3 and T4. The pulses of figures 3 a, 3b and 3 c represent preferred pulse shapes not limitative. For instance the slope change, of the pulse of figure 3 c, could be around at 90% of the whole trailing edge or there could be also the trailing edges with two slopes.

Now it is possible to define an example of at least three principal types of pulse with different shapes.

A pulse of alpha type with a waveform as in figure 3 a and for example the following characteristics T0= 10 μs, Tl= 20 μs, T2= 10 μs and Ti= 30 μs. This pulse has a symmetric waveform.

A pulse of beta type with a waveform as in figure 3b and for example the following characteristics T0= 10 μs, Tl= 20 μs, T2= 20 μs and Ti= 35

^"μs. This pulse^'has an asymmetric waveform.

A pulse of gamma type with a waveform as in figure 3 c, (change of slope at 70% of the whole edge) and for example the following characteristics T0= 10 μs, Tl= 30 μs, T2= 20 μs, T3= 10 μs, T4= 10 μs and Ti= 42 μs. This pulse has a particular asymmetric shape of the leading edge: it has a first slope of width T3 and a second slope of width T4.

The timing of above can be changed according to the necessity. For example, another interesting and useful pulse has a waveform as in figure 3 c, (change of slope at 70% of the whole leading edge) having the following characteristics T0= 1 μs, Tl= 1 μs, T2= 21 μs, T3= 20 μs, T4= 1 μs and Ti= 16.2 μs. The width T3 can also change between 5 and 80 μs, and TO, Tl and T4 can be further reduced, hi this way a pulse having the shape of an upside down rectangular trapezium, or in other words, a negative rectangular asymmetric pulse is obtained. In this way the pulse reach almost immediately the maximum voltage prefixed,' therefore the voltage decrease partially, of about 70 % in the time T3, and then return almost immediately at 0 Volt.

The choice of the correct pulse shapes is very important in the treatment of the different pathologies. It has been found that, depending on the particular therapy, some pulse shapes give better result then others. Further, improvement regarding the long lasting effects can be obtaining alternating, in same therapy, the type of the pulse shape.

Other important issues are the accurated choice of the pattern of the pulse width variations in the time and the variation of the pulse repetition frequency.

Stimulation frequencies differentiated for different pathologic problems have been obtained; for instance sequences for the control of pain, sequences for vessel contraction/vessel dilation, sequences for the trophic-immune regulation, sequences for muscle tone regulation. The sequence for the control of pain, have been defined with a sequence having a^" length of 15 minutes. In this sequence the beta type pulses with Tϊ= 25 μs, (T0= 10 μs, Tl= 10 μs, T2= 20 μs) and alpha type pulses with Ti= 20 μs, (T0= 10 μs, Tl= 10 μs, T2= 10 μs) are alternated (overlapped) with intermittent rhythm: A. stimulation of gamma type at 100 Hz for 5 minutes,

B. overlap of beta type at 55 Hz for the last 3 minutes of A,

A. stimulation of gamma type at 100 Hz for 5 minutes,

B. overlap of beta type at 55 Hz for the last 3 minutes of A,

C. overlap of alpha type at 15 Hz for the last 2 minutes of A, A. stimulation of gamma type at 100 Hz for 5 minutes. In this way a particular pulse sequence has been created, interlacing two different kinds of pulses.

For the control of the vascular contraction/dilation, low frequency stimulation of beta type is used with different length on which trains of alpha stimuli at high and increasing frequency are added, for a total of 15 minutes. In this case, the alpha type pulse has the following characteristics Ti= 20 μs, (T0= 10 μs, Tl= 10 μs, T2= 10 μs), and the beta type pulse has the following characteristics Ti= 25 μs, (T0= 10 μs, Tl= 10 μs, T2= 20 μs).

A. stimulation of beta type at 1.5 Hz, for 3 minutes, B. stimulation of beta type at 15 Hz, for 3 minutes,

A. stimulation of beta type at 1.5 Hz, for 3 minutes,

C. overlap onB of alpha type stimuli at 40 Hz, for the last 15 seconds,

D. overlap on B of alpha type at 70 Hz, for the last 5 seconds, A. stimulation of beta type at 1.5 Hz, for 3 minutes, B. stimulation of beta type at 15 Hz, for 3 minutes.

For the regulation of tissue trophism and immunity, the length of treatment is 16 minutes, hi this case, the alpha type pulse has the following characteristics Ti= 20 μs (T0= 10 μs, Tl= 10 μs, T2= 10 μs). A. stimulation of alpha type a at 1.5 Hz, for 2 minutes, B. stimulation of alpha type at 15 Hz, for 2 minutes,

A. stimulation of alpha type at 1.5 Hz, for 2 minutes, D. stimulation of alpha type at 15 Hz, for 2 minutes,

B. stimulation of alpha type at 1.5 Hz, for 2 minutes,

A. stimulation of alpha type at 15 Hz, for 2 minutes, D. stimulation of alpha type at 1.5 Hz, for 2 minutes,

B. stimulation of alpha type at 15 Hz, for 2 minutes.

It is possible for this therapy, instead of the alpha type pulses as above, it is possible use the gamma type pulses having the following characteristics T0= .1 μs, Tl= 1 μs, T2= 21 μs, T3= 20 μs, T4= 1 μs and Ti= 16.2 μs. The sequences formuscle tonification with a length of 4,30 minutes, has been defined as follows. In this case, the alpha type pulse, has the following characteristics Ti= 20 μs (T0= 10 μs, Tl= 10 μs, T2= 10 μs), the beta type pulse, has the following characteristics Ti= 25 μs (T0= 10 μs, Tl= 10 μs, T2= 20 μs), and the gamma type pulse, has the following characteristics Ti= 16.2 μs (T0= 1 μs, Tl= 1 μs, T2= 21 μs, T3= 20 μs, T4= 1 μs).

A. stimulation of gamma type at 100 Hz, for 2 minutes,

B. overlap on A of beta type at 5 Hz, in the last minute of A,

C. overlap on B, of stimulation of alpha type at 30 Hz, in the last 30 seconds of B, D. stimulation of alpha type at 40 Hz, for 15 seconds,

E. stimulation of alpha type at 70 Hz, for 10 seconds,

F. stimulation of alpha type at 80 Hz, for 5 seconds,

A. stimulation of gamma type at 100 Hz, for 2 minutes, Pause of 10 seconds. The whole A, B, C, D, E, F, A and pause sequence, could be repeated up to three times in succession.

The sequence for muscle contraction and de-contraction regulation having a length of 1 -5 minutes has been defined as follows.

A continuous sequence of gamma type pulses (T0= 10 μs, Tl= 30 μs, T2= 20 μs, T3= 10 μs, T4= 10 μs and Ti= 42 μs), overlapping alpha pulses

(T0= 10 μs:Tl= 20 μs, T2=10 μs and Ti= 30 μs) after 30 seconds of the started sequence, at 1 Hz for 15 seconds, then the alpha pulses increase their repetition frequency from 1 Hz to 10 Hz for 5 seconds, then the alpha pulses increase repetition frequency from 10 Hz to 40 Hz for 5 seconds. That is, in this case, the repetition frequency is increased in linear (or also in logarithm) way meanwhile the sequence is running.

The sequences of pulses defined in these therapies are to be considered only examples, non limitative, as they are subject to variations of form and width of the pulses and of the repetition frequency according to the various pathologies and conditions. In the treatment of the different pathologies is possible to repeat different or equal sequence types to form a complete course.

For example, in the chronic lumbosacral pain treatment a preferred order of the sequences is the following. At each sequence is associated a reference to be distinguished and for clarity.

A vascular sequence VI, an anti-inflammatory sequence Al, two vascular sequence Vl+Vl, a modified vascular sequence V2, a modified vascular sequence V3, a modified vascular sequence V4, a vascular sequence VI, an anti-inflammatory sequence Al, a decontracting sequence D 1 , a modified decontracting sequence D2, a modified decontracting sequence D3, a sequence acting on the nervous system Nl.

For example, in the tendinitis treatment a preferred order of the sequences is the following.

A vascular sequence VI, a modified vascular sequence V2, a modified vascular sequence V3, a decontracting sequence Dl , a modified vascular sequence V2, a modified decontracting sequence D2, a modified decontracting sequence D3, a modified decontracting sequence D4, a modified vascular sequence V2, a modified vascular sequence V3, a modified vascular sequence V4, a modified sequence acting on the nervous system N3.

For example, in ^"the sciatic and crural neuralgia treatment a preferred order of the sequences is the following.

A modified anti-inflammatory sequence A2, an anti-inflammatory sequence Al, a modified sequence acting on the nervous system N2, a vascular sequence VI, an anti -inflammatory sequence Al, a vascular sequence VI, an anti-inflammatory sequence Al, a modified vascular sequence V2, a modified vascular sequence V3, a decontracting sequence Dl, a modified decontracting sequence D2, a modified decontracting sequence D3, a modified sequence acting on the nervous system N2. In this way, the stimulation with different kind of sequences allows modifying body functions, it strengthens the feedback with the central regulating system and provides effective and persistent therapy.

The pattern variations of duration L, width W, and repetition frequency F of the above sequences are substantially the followings. The decontracting sequences Dl, D2, D3 start with pulses having short width (W~20μs), short repetition frequency (F-l-4 Hz) and short duration (L~20 s), then the width become wider than before (W~40 μs), the repetition frequency increase linearly (F~from 4 to 60 Hz) and the duration decrease (D=2 s). The vascular sequences VI, V2, V3, V4 have pulses with cyclic

(sinusoidal) width (W~10- 40μs), repetition frequency substantial fixed (F~3 Hz) with some short peak (F-10-30 Hz), and short duration (L~2 s).

The sequences acting on the nervous system Nl, N2, N3 start with pulses having short width (W~20μs), short repetition frequency (F-l-4 Hz) and variable duration (L-2-30 s), then the width is decreased (W~l Oμs), the repetition frequency is increased a lot (F~l 00-4000 Hz) and the duration is reduced (L~2 s).

A sequence of stimuli, as the sequences acting on the nervous system Nl, is performed on the palm of the hand at 110 Hz of frequency and Ti= 40 μs, has been noted by recording the late components of the over maximal excitation of the median nerve with cutaneous electrodes.

A preliminary recording has been performed with the classical orthodromic technique, on the palm of the hand, and the signal obtained is the one of figure 4 (average of 80 responses). This signal has been subjected to analysis of spectrum frequency and the results are shown in figure 5, where it has been reported the signal power at different frequencies. hi the spectrum, constant peak components may be distinguished (recordings effected on five healthy subjects).

Applying the base sequence on the palm of the hand, with frequency 100 Hz and width Ti= 40 μs, an evident alteration of the frequency spectrum was found as shown in figure 6.

It can be seen that the power of the peak was greatly increased and the de-synchronised components reduced. In other words the application of the stimulatory sequence seems to re-organize the frequency of the pulses from the afferent nerves and to group the bands of frequency into more synchronised values. hi the above examples forms of pulses and specific sequences of stimulations have been defined to treat some pathological conditions. They are to be considered only as a non-limitative example and susceptible of modifications in accordance to various pathologic conditions. For instance, the specific sequence for the modulation of the vessel motility presents a series of frequency increases smaller than the ones used in muscles motility, a longer periods of gamma pulses, frequency increases in the first phase and by periodical changes of repetition frequency in the second final period.

Claims

CLAIMS 1. System for the electric stimulation of a patient comprising: at least two electrodes able to be applied on the body of said patient; means for generating electric pulses between said at least two electrodes; said electric pulses have amplitude, width and frequency of repetition selectively variable; characterized by further comprising: a control system of said means for generating electric pulses; said control system controls said means for generating electric pulses in order to feed, automatically according to a prefixed succession, to said at least two electrodes a sequence of said electric pulses having variable width and repetition frequency in the time, said sequence include a first type of pulse having an asymmetric shape.

2. System for the electric stimulation of a patient according to claim 1 characterized by comprising a second type of pulse having a symmetric shape.

3. System for the electric stimulation of a patient according to claim 1 characterized in that said first type of pulse has a shape of an upside down rectangular trapezium.

4: System for the electric-stimulation of a patient according to claim 1 . characterized in that said sequence of said electric pulses comprises a first type of pulse and a second type of pulse, said first type of pulse having a width greater then the width of the second type of pulse.

5. System for the electric stimulation of a patient according to claim 1 characterized in that said sequence of said electric pulses having width variable in the time, allow the re- arrangement of the components of frequency (synchronization) of the afferent nervous with an amplification of frequency bands.

6. System for the electric stimulation of a patient according to claim 1 characterized by further comprising a computer which has stored on it a plurality of sequence each one associates to a related therapy, and each therapy is selectable by means of a tree structure presented on the screen of said computer.

7. System for the electric stimulation of a patient according to claim 1 characterized by providing to said patient a plurality of sequences of said electric pulses that constitute a therapy.

8. System for the electric stimulation of a patient according to claim 7 characterized in that said plurality of sequence comprises decontracting sequences, vascolar sequences, sequences acting on the nervous system according to a prefixed succession.

9. Method for providing electric stimuli to a patient comprising the phases of: choosing the body region where a therapy is to be applied by means of a tree structure; applying at least two electrodes on the body of said patient; generating electric pulses between said at least two electrodes; feeding to said at least two electrodes, automatically according to a prefixed succession, a sequence of said electric pulses having width and repetition frequency variable in the time.

10. Method according to claim 9 characterized in that the phase of choosing the body region where a therapy is to be applied, comprises the phase of choosing the body region among a first list of body region shown on a display.

11. Method according to claim 10 characterized in that after the phase of choosing the body region among a first list of body region shown on a display, there is the phase of choosing a body part within the region previous chosen, in a second list showed on said display.

12. Method according to claim 11 characterized in that after the phase of choosing said body part within the region previous chosen, there is the phase to choose the kind of the therapy wanted showed in a second list on said display.

13. Method according to claim 9 characterized in that the phase of applying at least two electrodes on the body of said patient comprises the phase of showing on said display the points of the body where the electrodes must be placed.