EP1526892A1 - System zur erzeugung von programmierten reizen, die zu einer geregelten und persistenten physiologischen reaktion im körper führen - Google Patents

System zur erzeugung von programmierten reizen, die zu einer geregelten und persistenten physiologischen reaktion im körper führen

Info

Publication number
EP1526892A1
EP1526892A1 EP03715861A EP03715861A EP1526892A1 EP 1526892 A1 EP1526892 A1 EP 1526892A1 EP 03715861 A EP03715861 A EP 03715861A EP 03715861 A EP03715861 A EP 03715861A EP 1526892 A1 EP1526892 A1 EP 1526892A1
Authority
EP
European Patent Office
Prior art keywords
patient
sequence
pulse
electric
therapy
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Withdrawn
Application number
EP03715861A
Other languages
English (en)
French (fr)
Inventor
Mauro Pastori
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Patents Exploitation Co BV
Original Assignee
Patents Exploitation Co BV
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Patents Exploitation Co BV filed Critical Patents Exploitation Co BV
Publication of EP1526892A1 publication Critical patent/EP1526892A1/de
Withdrawn legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/36014—External stimulators, e.g. with patch electrodes
    • A61N1/36021—External stimulators, e.g. with patch electrodes for treatment of pain

Definitions

  • 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 hydrocortisone excess due to the stress carries to an increase of the visceral fat, insulin excess, resistance to insulin, dislipidemia,
  • 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.
  • 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
  • said sequence include a first type of pulse having an asymmetric shape.
  • 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.
  • 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.
  • 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.
  • the apparatus object of the present invention is able to send sequences of selective and specific pulses to nerves, vessels, muscles and immune system.
  • 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.
  • 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
  • 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.
  • 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.
  • 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.
  • 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.
  • a container 5 that contains the circuits devoted to the generation of the electric pulses.
  • 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 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.
  • 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.
  • 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.
  • the computer 1 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.
  • a menu with a list of the main body regions for example spine, leg, arm, etc.
  • a sub menu with a detailed list of the part of said body region for example cervical spine, lumbar spine
  • 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.
  • the points where the electrodes must be applied are indicated. Then, pushing a button available on the computer the therapy is enabled.
  • the time will be decremented accordingly, until the time will be zero and the therapy will be finished.
  • FIGS. 3 a, 3b and 3 c 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.
  • 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.
  • 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.
  • This pulse has a symmetric waveform.
  • This pulse ' has an asymmetric waveform.
  • 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 width T3 can also change between 5 and 80 ⁇ s, 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.
  • 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.
  • the whole A, B, C, D, E, F, A and pause sequence, could be repeated up to three times in succession.
  • 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.
  • 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.
  • 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.
  • 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 vascular sequences VI, V2, V3, V4 have pulses with cyclic
  • the sequences acting on the nervous system Nl, N2, N3 start with pulses having short width (W ⁇ 20 ⁇ s), short repetition frequency (F-l-4 Hz) and variable duration (L-2-30 s), then the width is decreased (W ⁇ l O ⁇ s), the repetition frequency is increased a lot (F ⁇ l 00-4000 Hz) and the duration is reduced (L ⁇ 2 s).
  • the power of the peak was greatly increased and the de-synchronised components reduced.
  • 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.
  • 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.
  • 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.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Biomedical Technology (AREA)
  • Biophysics (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Pain & Pain Management (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Radiology & Medical Imaging (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Electrotherapy Devices (AREA)
EP03715861A 2002-07-29 2003-04-02 System zur erzeugung von programmierten reizen, die zu einer geregelten und persistenten physiologischen reaktion im körper führen Withdrawn EP1526892A1 (de)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
NL0200512 2002-07-29
WOPCT/NL02/00512 2002-07-29
PCT/NL2003/000245 WO2004011087A1 (en) 2002-07-29 2003-04-02 System designed to generate programmed sequences of stimuli resulting in controlled and persistent physiological responses in the body

Publications (1)

Publication Number Publication Date
EP1526892A1 true EP1526892A1 (de) 2005-05-04

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EP03715861A Withdrawn EP1526892A1 (de) 2002-07-29 2003-04-02 System zur erzeugung von programmierten reizen, die zu einer geregelten und persistenten physiologischen reaktion im körper führen

Country Status (3)

Country Link
EP (1) EP1526892A1 (de)
AU (1) AU2003219618A1 (de)
WO (1) WO2004011087A1 (de)

Cited By (1)

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US10792495B2 (en) 2016-12-01 2020-10-06 Thimble Bioelectronics, Inc. Neuromodulation device and method for use

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Publication number Priority date Publication date Assignee Title
US7613518B2 (en) 2004-06-15 2009-11-03 Encore Medical Asset Corporation Interferential and neuromuscular electrical stimulation system and apparatus
US8140165B2 (en) 2005-01-28 2012-03-20 Encore Medical Asset Corporation Independent protection system for an electrical muscle stimulation apparatus and method of using same
EP2392381B1 (de) 2005-04-19 2016-07-20 Compex Technologies, Inc. Elektrische Stimulationsvorrichtung
US8620438B1 (en) 2007-02-13 2013-12-31 Encore Medical Asset Corporation Method and apparatus for applying neuromuscular electrical stimulation

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US3881495A (en) * 1973-08-08 1975-05-06 Anthony N Pannozzo Method of nerve therapy using trapezoidal pulses
US4431000A (en) * 1978-11-29 1984-02-14 Gatron Corporation Transcutaneous nerve stimulator with pseusorandom pulse generator
ES8703745A1 (es) * 1984-06-05 1987-03-01 Codman & Shurtleff Un metodo para producir una secuencia o serie de pulsacionesde tratamiento en un dispositivo de estimulacion nerviosa transcutanea
JPH064096B2 (ja) * 1987-03-25 1994-01-19 株式会社アドバンス 皮膚貼着型低周波治療器
US5097833A (en) * 1989-09-19 1992-03-24 Campos James M Transcutaneous electrical nerve and/or muscle stimulator
US5184617A (en) * 1990-06-05 1993-02-09 Staodyn, Inc. Output pulse compensation for therapeutic-type electronic devices
US6704603B1 (en) * 2000-05-16 2004-03-09 Lockheed Martin Corporation Adaptive stimulator for relief of symptoms of neurological disorders

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Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US10792495B2 (en) 2016-12-01 2020-10-06 Thimble Bioelectronics, Inc. Neuromodulation device and method for use
US11801383B2 (en) 2016-12-01 2023-10-31 Hinge Health, Inc. Neuromodulation device and method for use

Also Published As

Publication number Publication date
AU2003219618A1 (en) 2004-02-16
WO2004011087A1 (en) 2004-02-05

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