WO2017140932A1 - Electric current generating device for use in the treatment of motor disorders, sensory disorders and pain - Google Patents

Electric current generating device for use in the treatment of motor disorders, sensory disorders and pain Download PDF

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Publication number
WO2017140932A1
WO2017140932A1 PCT/ES2017/070080 ES2017070080W WO2017140932A1 WO 2017140932 A1 WO2017140932 A1 WO 2017140932A1 ES 2017070080 W ES2017070080 W ES 2017070080W WO 2017140932 A1 WO2017140932 A1 WO 2017140932A1
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WO
WIPO (PCT)
Prior art keywords
current
disorders
electric current
khz
pain
Prior art date
Application number
PCT/ES2017/070080
Other languages
Spanish (es)
French (fr)
Inventor
Juan AVENDAÑO COY
Julio GÓMEZ SORIANO
Julian Taylor Green
Original Assignee
Universidad De Castilla- La Mancha
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
Priority to ESP201630168 priority Critical
Priority to ES201630168A priority patent/ES2629902B1/en
Application filed by Universidad De Castilla- La Mancha filed Critical Universidad De Castilla- La Mancha
Publication of WO2017140932A1 publication Critical patent/WO2017140932A1/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/18Applying electric currents by contact electrodes
    • A61N1/32Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36Applying electric currents by contact electrodes alternating or intermittent currents for stimulation

Abstract

The invention relates to an electric current generating device for use in the treatment of motor disorders, sensory disorders and pain, comprising at least one amperage selector, a milliammeter and electric current output terminals. According to the invention, the current generated by the device is uninterrupted, with a frequency of between 10 and 50KHz, a pulse width of between 20 and 100 μs, and amperage of between 1 and 200 mA.

Description

ELECTRICAL CURRENT GENERATOR device for use in the treatment of motor disorders, sensory disorders and

PAIN

FIELD OF THE INVENTION

The technical field of the present invention is electromedicina. In particular, the technical field relates to devices generating electric current for therapeutic purposes. The therapeutic purpose is the treatment of motor disorders, sensory disorders and pain. BACKGROUND OF THE INVENTION

Within the field of physical therapy, physical medicine and rehabilitation, in particular in the application of electric current for therapeutic purposes, the frequencies used are currently less than 10 KHz and also interrupted or modulated (Current Interferential Nemec, Russian Stimulation and Aussie current) (Fig. 1).

DESCRIPTION OF THE INVENTION

The technical problem in view of the prior art nearest can be defined as a generator providing electric currents alternative device for use in the treatment of motor disorders, sensory disorders and pain. The solution to this problem is to provide the electrical current generating device defined by the claims of the present patent application.

In a first aspect, the present invention I provide a generator device electrical currents for use in the treatment of motor disorders, sensory disorders and pain, comprising a selector current, a milliammeter and terminals terminals for electrical current output, characterized that the current generated by the device is uninterrupted, at a frequency between 10 and 50 KHz, with a pulse width between 20 and 100 με and a current between 1 and 200 mA. A second aspect is the device according to the first aspect of the invention, comprising an indicator impedance or skin resistance. A third aspect is the device according to the first aspect of the invention, where the waveform of the alternating current is sinusoidal or rectangular.

According to the third aspect of the invention may select two forms of selecciónateles wave device: AC sinusoidal alternating rectangular (Fig. 2). The rectangular alternating wave form has shown a block threshold lower in preclinical animal studies that sinusoidal.

In the first, second or third aspect of the invention, the electric current generated by the device no interruptions or modulations being uninterrupted flow. In the first, second or third aspect of the invention, the pulse width of the electric current is variable depending on the frequency. The pulse width of the electrical current is selected from 20 to 50 KHz με 100 με and 10 KHz.

In the first, second or third aspect of the invention, the intensity of electrical current is between 1 and 200 will select two options mA, constant current (CC) or constant voltage (CV) (100 - 250 V).

In the first, second or third aspect of the invention, a calculation of current density (mA / cm2) depending on the size of electrodes applied is performed.

In the first, second or third aspect of the invention, the device comprises a cord outlet, for connecting the device to the mains. In the first, second or third aspect of the invention, the device comprises terminals terminals (5) for connecting cables 2 mm diameter outlet for computer-patient.

In the first, second or third aspect of the invention, the duration of electric current is selectable between 1 and 60 minutes with a timer or generated electric current indefinitely. Only the electric current would break down the intensity or turning off the computer.

Another aspect is the device according to the first, second or third aspect of the invention, wherein the motor disorder is spasticity, dystonia or tremor.

Neuromodulation produced by the alternating current generated by the device of the first, second or third aspect of the invention is readily reversible after application and does not cause tissue damage on the tissues. Human studies performed herein have demonstrated the safety of application and have shown transient and rapidly reversible neurophysiological changes in nerve conduction, without producing morphological alterations or undesirable effects on tissues stimulated. In studies in the present invention it has not shown any adverse effect, so it can be considered that the neuromodulation produced by the alternating current generated by the device of the first aspect of the invention is a secure application.

The alternating current generated by the device of the first, second or third aspect of the invention has differential effects regarding interrupted currents used in the prior art. Specifically while interrupted currents emitted by other devices cause depolarization of the nervous system generating potential of motor and sensory action, the alternating current generated by the device of the first or second aspect of the invention has the opposite effect, blocking conduction of action potentials and this transient and reversible block after the current ceases. Thus the present invention is of great therapeutic interest in diseases characterized by hyperactivity of the nervous system such as spasticity or chronic pain that have a high prevalence. The alternating current generated by the device of the first, second or third aspect of the invention has potential application in treatment centers motor and / or sensory disorders. They can also be applied to the field of study and research in neurophysiology, since selective blocking of certain types of nerve fibers facilitates the analytical study of others. BRIEF DESCRIPTION OF THE FIGURES

Figure 1. Graphic representation (intensity / time) of interferential currents (a), Currents Russian (b) and Current Aussie (c) emitted by other devices. They all have interruptions or modulations of the current and also have a lower frequency to 10KHz. Figure 2. Graphic representation (intensity / time) of the waveform used in the invention. In the upper part and alternating sinusoidal alternating rectangular bottom.

Figure 3. Schematic of a generator device electrical currents. Figure 4. Normalized effect stimulation sinusoidal alternating electric currents 10 and 20 KHz according to the invention applied on the median and ulnar nerve, compared to other current considered the reference standard (current TENS) and stimulation placebo on the motor response (force voluntary maximum) isometric. *: P <0.05; ***: p <0.001. Pre: measurement before stimulation; 15min: measurement within 15 minutes of stimulation; Post 0: directly after stimulation measurement; Post 10: measurement at 10 minutes to complete the stimulation. The circles represent the results of placebo stimulation, the squares represent the results with current TENS, the diamonds represent the results with sinusoidal alternating electric current 10 KHz and the triangles represent the results with sinusoidal alternating electric current 20 KHz.

Figure 5. Effect normalized stimulation with sinusoidal alternating electric currents 10 and 20 KHz according to the invention applied to the median nerve, compared to placebo stimulation on the pain threshold to pressure. *: P <0.05. Pre: measurement before stimulation; 15min: measurement within 15 minutes of stimulation; Post 0: directly after stimulation measurement; Post 10: measurement at 10 minutes to complete the stimulation. The circles represent the results of placebo stimulation, the diamonds represent the results with sinusoidal alternating electric current 10 KHz and the squares represent the results with sinusoidal alternating electric current 20 KHz.

Figure 6. Effect on the maximum / H ratio M Maximum stimulation with sinusoidal alternating electrical currents 10 KHz according to the invention applied transcutaneously to spinal level, compared with placebo stimulation and another current reference pattern considered (TENS). *: P <0.05. Pre: measurement before stimulation; Dur: measurement after 33 minutes stimulation. Post: Measuring 10 minutes to complete the stimulation.

The circles represent the results of placebo stimulation, the squares represent the results with current TENS and the diamonds represent the results with alternating electrical currents sinusoidal 10KHz.

PREFERRED EMBODIMENT MODES

Example 1. sinusoidal alternating current generator uninterrupted with a frequency range between 10 KHz and 50 KHz in Fig. 3 shows schematically a generator of sinusoidal alternating currents with uninterrupted frequency range between 10 KHz and 50 KHz .

The generator comprises:

- display (1). - selectors (2) of electric current

- milliammeters (3)

- terminals terminals (4) for electric current output

- outlet (5) of the power cable to the mains.

- indicator (6) impedance or skin resistance (ΚΩ) on the display (1) the waveform is selected, the frequency output mode (constant current (CC) or constant voltage (CV)) and the time application (using a timer).

There are two selectors (2) of current intensity of independent electric current selector for channel 1 and selector for channel 2. The intensity can be selected in steps of 0, 1 mA to 10 mA and 1 mA steps from 10 mA to 200 mA.

The milliammeters (3) expresses the intensity values ​​in absolute values ​​(mA) and current density (mA / cm2).

Output terminals (4) have a connection for connecting cables 2 mm diameter for the current output from the computer to the patient.

Example 2. Clinical Trials

They were performed 5 clinical trials applied in healthy humans, supported by previous basic research on animals. In the five trials transcutaneous application of sinusoidal alternating currents with uninterrupted frequency range between 10 KHz and 50 KHz with a current reference pattern considered in transcutaneous application known as TENS (Transcutaneous Electrical Nerve Stimulation) and placebo compared stimulation. The localization of electrical stimulation in the experiments was made in the peripheral nervous system in internal popliteal sciatic nerve of lower limb, median, radial and ulnar upper member and on the central nervous system in the spinal metameras S1 and S2 corresponding T10-12 bone level.

Studies have shown that transcutaneous application of sinusoidal alternating currents uninterrupted with a frequency range between 10 KHz and 50 KHz in the path of peripheral nerves produces a modulation in the motor and sensory response than the placebo stimulation and current TENS considered pattern reference. This modulation of nerve activity is of interest in disorders characterized by overactivity nervous system and have a high prevalence such as spasticity and / or chronic pain (Fig. 4 and Fig. 5).

With regard to the core application of sinusoidal alternating currents with uninterrupted frequency range between 10 KHz and 50 KHz the H reflex as quantization excitability alpha motor neuron was measured. Its parameters were used as an indirect indicator of spasticity. Patients with spasticity usually have the H reflex increased. In the present invention a decreased H / M ratio with sinusoidal alternating currents with uninterrupted frequency range between 10 KHz and 50 KHz, with no change in placebo stimulation or TENS (Fig. 6) was recorded.

Furthermore, 68.4% (p = 0.023) of the subjects perceived uninterrupted sinusoidal alternating currents with a frequency range between 10 KHz and 50 KHz as a more comfortable than the TENS currents. Although in the first the current density was higher.

Claims

What is claimed
1. Device for generating electrical currents for use in the treatment of motor disorders, sensory disorders and pain, comprising at least one selector current, a milliammeter terminals and terminals for electrical current output, characterized in that the current generated by the device is uninterrupted, at a frequency between 10 and 50 KHz, with a pulse width between 20 and 100 S and a current between 1 and 200 mA.
2. Device according to claim 1, characterized by comprising an indicator impedance or skin resistance.
3. Device according to claim 1 or 2, characterized in that the waveform of the alternating current is sinusoidal or rectangular.
4. Device according to any of claims 1 to 3, wherein the motor disorder is spasticity, dystonia or tremor.
PCT/ES2017/070080 2016-02-15 2017-02-13 Electric current generating device for use in the treatment of motor disorders, sensory disorders and pain WO2017140932A1 (en)

Priority Applications (2)

Application Number Priority Date Filing Date Title
ESP201630168 2016-02-15
ES201630168A ES2629902B1 (en) 2016-02-15 2016-02-15 Device for generating electrical currents for use in the treatment of motor disorders, sensory disorders and pain

Publications (1)

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WO2017140932A1 true WO2017140932A1 (en) 2017-08-24

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Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20100191307A1 (en) * 2009-01-29 2010-07-29 Zi-Ping Fang Systems and methods for producing asynchronous neural responses to treat pain and/or other patient conditions
EP2243510A2 (en) * 2009-04-22 2010-10-27 Nevro Corporation Selective high frequency spinal cord modulation for inhibiting pain with reduced side effects, and associated systems and methods
US20120035683A1 (en) * 2004-07-09 2012-02-09 Simon Bruce J Method for treating degenerative disc disease using noninvasive capacitively coupled electrical stimulation device
US20130066411A1 (en) * 2011-09-08 2013-03-14 James R. Thacker Selective high frequency spinal cord modulation for inhibiting pain, including cephalic and/or total body pain with reduced side effects, and associated systems and methods
US20130304152A1 (en) * 2012-05-14 2013-11-14 Boston Scientific Neuromodulation Corporation System and method for shaped phased current delivery
US20150005852A1 (en) * 2013-06-28 2015-01-01 Boston Scientific Neuromodulation Corporation Transcutaneous electrical stimulation for treating neurological disorders
US20150100112A1 (en) * 2013-10-09 2015-04-09 Gimer Medical Co. Ltd. Electromagnetic stimulation device for changing nerve threshold

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20120035683A1 (en) * 2004-07-09 2012-02-09 Simon Bruce J Method for treating degenerative disc disease using noninvasive capacitively coupled electrical stimulation device
US20100191307A1 (en) * 2009-01-29 2010-07-29 Zi-Ping Fang Systems and methods for producing asynchronous neural responses to treat pain and/or other patient conditions
EP2243510A2 (en) * 2009-04-22 2010-10-27 Nevro Corporation Selective high frequency spinal cord modulation for inhibiting pain with reduced side effects, and associated systems and methods
US20130066411A1 (en) * 2011-09-08 2013-03-14 James R. Thacker Selective high frequency spinal cord modulation for inhibiting pain, including cephalic and/or total body pain with reduced side effects, and associated systems and methods
US20130304152A1 (en) * 2012-05-14 2013-11-14 Boston Scientific Neuromodulation Corporation System and method for shaped phased current delivery
US20150005852A1 (en) * 2013-06-28 2015-01-01 Boston Scientific Neuromodulation Corporation Transcutaneous electrical stimulation for treating neurological disorders
US20150100112A1 (en) * 2013-10-09 2015-04-09 Gimer Medical Co. Ltd. Electromagnetic stimulation device for changing nerve threshold

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Publication number Publication date
ES2629902A1 (en) 2017-08-16
ES2629902B1 (en) 2018-06-07

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