专利摘要:
Device for generating electric currents for use in the treatment of motor disorders, sensory disorders and pain, comprising at least one current-intensity selector, a milliammeter and terminal terminals for electrical current output, where the current generated by the device is uninterrupted, with a frequency between 10 and 50 khz, with a pulse width between 20 and 100 μs and with a current intensity between 1 and 200 ma. (Machine-translation by Google Translate, not legally binding)
公开号:ES2629902A1
申请号:ES201630168
申请日:2016-02-15
公开日:2017-08-16
发明作者:Juan AVENDAÑO COY;Julio GÓMEZ SORIANO;Julian Taylor Green
申请人:Universidad de Castilla La Mancha;
IPC主号:
专利说明:

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ELECTRICAL CURRENT GENERATOR DEVICE FOR USE IN THE TREATMENT OF MOTOR DISORDERS, SENSITIVE DISORDERS AND PAIN
DESCRIPTION
FIELD OF THE INVENTION
The technical field of the present invention is electromedicine. Specifically, the technical field refers to electric current generating devices for therapeutic purposes. The therapeutic purpose is the treatment of motor disorders, sensory disorders and pain.
BACKGROUND OF THE INVENTION
Within the field of physiotherapy, physical medicine and rehabilitation, more specifically in the application of electric currents for therapeutic purposes, the frequencies currently used are less than 10 KHz and also interrupted or modulated (Nemec Interference Currents, Russian Stimulation and Aussie currents) (Fig. 1).
DESCRIPTION OF THE INVENTION
The technical problem in view of the closest state of the art can be defined as the contribution of an alternative electric current generating device for use in the treatment of motor disorders, sensory disorders and pain.
The solution to this problem is to provide the electric current generating device defined by the claims of the present patent application.
In a first aspect, the present invention provides an electric current generating device for use in the treatment of motor disorders, sensory disorders and pain, which comprises a current intensity selector, a milliammeter and terminal terminals for electrical current output, characterized because the current generated by the device is uninterrupted, with a frequency between 10 and 50 KHz, with a pulse width between 20 and 100 ps and with a current intensity between 1 and 200 mA.
A second aspect is the device according to the first aspect of the invention, which
It comprises an indicator of impedance or cutaneous resistance.
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According to the third aspect of the invention, two selectable waveforms can be selected in the device: sinusoidal alternating and rectangular alternating (Fig. 2). The rectangular alternating waveform has shown a lower blocking threshold in preclinical studies in animals than the sinusoidal one.
In the first, second or third aspect of the invention, the electric current generated by the device has no interruptions or modulations, the flow being uninterrupted.
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 electric current is selected between 20 gs at 50 KHz and 100 gs at 10 KHz.
In the first, second or third aspect of the invention, the intensity of the electric current is selectable between 1 and 200 mA with two options, Constant Current (DC) or Constant Voltage (CV) (between 100 - 250 V).
In the first, second or third aspect of the invention, a current density calculation (mA / cm2) is performed depending on the size of electrodes applied.
In the first, second or third aspect of the invention, the device comprises an outlet of the power cable, to connect the device to the electrical network.
In the first, second or third aspect of the invention, the device comprises terminal terminals (5) for connecting 2 mm diameter cables for current output of the patient-equipment.
In the first, second or third aspect of the invention, the duration of the electric current can be selected between 1 and 60 minutes with a timer or the electric current can be generated indefinitely. Only the electric current will be interrupted by lowering the intensity or turning off the equipment.
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The neuromodulation produced by the alternating current generated by the device of the first, second or third aspect of the invention is rapidly reversible after application and does not cause tissue damage to the tissues. The human studies carried out in the present invention have shown the safety of the application and have demonstrated transient and rapidly reversible neurophysiological modifications in nerve conduction, without producing morphological alterations or undesirable effects on stimulated tissues.
In the studies carried out in the present invention no adverse effect has been evidenced, so that the neuromodulation produced by the alternating current generated by the device of the first aspect of the invention can be considered a safe application.
The alternating current generated by the device of the first, second or third aspect of the invention has differential effects with respect to the interrupted currents used in the state of the art. Specifically while the interrupted currents emitted by other devices cause the depolarization of the nervous system generating motor and sensitive action potentials, the alternating current generated by the device of the first or second aspect of the invention produces the opposite effect, blocking the conduction of action potentials. , this blocking being transient and reversible once the current ceases. In this way the present invention is of great therapeutic interest in pathologies 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 great potential for application in treatment centers for motor and / or sensitive disorders. They can also be applied to the field of study and research in neurophysiology, since the selective blocking of certain types of nerve fibers facilitates the analytical study of others.
BRIEF DESCRIPTION OF THE FIGURES
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Figure 1. Graphical representation (intensity / time) of the Interferential Currents (a), Russian Currents (b) and Aussie Currents (c) emitted by other devices. All of them have interruptions or modulations of the current and also have a frequency lower than 10KHz.
Figure 2. Graphical representation (intensity / time) of the waveform used in the invention. In the upper part alternates sinusoidal and in the lower part alternates rectangular.
Figure 3. Scheme of an electric current generating device.
Figure 4. Normalized effect of stimulation with alternating electric currents
10 and 20 KHz sinusoidal according to the invention applied to the median and ulnar nerve, compared with another current considered a reference pattern (TENS current) and placebo stimulation on the motor response (maximum isometric voluntary force). *: p <0.05; ***: p <0.001. Pre: measurement before stimulation; 15min: measurement 15 minutes after stimulation; Post 0: measurement right at the end of the stimulation; Post 10: measurement 10 minutes after the end of the stimulation. The circles represent the results of placebo stimulation, the squares represent the results with the TENS current, the rhombuses represent the results with 10 KHz sinusoidal electric current and the triangles represent the results with 20 KHz sinusoidal alternating electric current.
Figure 5. Normalized effect of stimulation with alternating electric currents
10 and 20 KHz sinusoidal according to the invention applied to the median nerve, compared with placebo stimulation over the pressure pain threshold. *: p <0.05. Pre: measurement before stimulation; 15min: measurement 15 minutes after stimulation; Post 0: measurement right at the end of the stimulation; Post 10: measurement 10 minutes after the end of the stimulation. The circles represent the results of placebo stimulation, the rhombuses represent the results with 10 KHz sinusoidal alternating electric current and the squares represent the results with 20 KHz sinusoidal alternating electric current.
Figure 6. Effect on the maximum H / M Maximum ratio of stimulation with alternating sinusoidal electric currents 10 KHz according to the invention applied transcutaneously at the medullary level, compared with placebo stimulation and other current considered reference standard (TENS). *: p <0.05. Pre: measurement before stimulation; Dur: measurement to
33 minutes of stimulation. Post: measurement 10 minutes after the end of the stimulation.
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The circles represent the results of placebo stimulation, the squares represent the results with the TENS current and the rhombuses represent the results with 10 KHz sinusoidal alternating electric currents.
PREFERRED EMBODIMENTS
Example 1. Example of generator of uninterrupted sinusoidal alternating currents with a frequency range between 10 KHz and 50 KHz
In Fig. 3 a generator of uninterrupted sinusoidal alternating currents with a frequency range between 10 KHz and 50 KHz is shown schematically.
The generator comprises:
- screen (1).
- selectors (2) of electric current intensity
- milliammeter (3)
- terminal terminals (4) for electric current output
- output (5) of the power cable to the mains.
- indicator (6) of impedance or skin resistance (KQ)
On the screen (1) the waveform, the frequency, the output mode (Constant Current (DC) or Constant Voltage (CV)) and the application time (by means of a timer) are selected.
There are two independent electric current intensity selectors (2), selector for channel 1 and selector for channel 2. The intensity can be selected in steps of 0.1 mA to 10 mA and in steps of 1 mA from from 10 mA to 200 mA.
The milliammeter (3) expresses the intensity values in absolute values (mA) and in current density (mA / cm2).
The terminal terminals (4) have a connection to connect 2 mm diameter cables for the current output of the equipment to the patient.
Example 2. Clinical tests
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Five clinical trials have been performed, applied in healthy humans, supported by previous basic research with animals. In the five trials, the transcutaneous application of uninterrupted alternating sinusoidal currents with a frequency range between 10 KHz and 50 KHz was compared with a current considered reference standard in transcutaneous application known as TENS (Transcutaneus Electrical Nerve Stimulation) and with placebo stimulation. The location of the electrical stimulation in the different tests was carried out at the level of the peripheral nervous system in the inner popliteal sciatic nerve of the lower limb, median, radial and ulnar nerves of the upper limb and at the level of the central nervous system in the corresponding S1 and S2 medullary metameres at bone level T10-12.
Studies have shown that the transcutaneous application of uninterrupted alternating sinusoidal currents with a frequency range between 10 KHz and 50 KHz in the peripheral nerve pathway produces a modulation in the motor and sensory response superior to placebo stimulation and the TENS current considered standard reference. This modulation of nerve activity is of interest in disorders that are characterized by hyperactivity of the nervous system and have a high prevalence such as spasticity and / or chronic pain (Fig. 4 and Fig. 5).
Regarding the spinal application of uninterrupted alternating sinusoidal currents with a frequency range between 10 KHz and 50 KHz, the H reflex was measured as quantification of the excitability of the motor neuron alpha. Its parameters have been used as an indirect indicator of spasticity. Patients with spasticity usually have an increased H reflex. In the present invention, a decrease in the H / M ratio with the uninterrupted alternating sinusoidal currents with a frequency range between 10 KHz and 50 KHz was recorded, without changes in placebo stimulation or TENS (Fig. 6).
On the other hand, 68.4% (p = 0.023) of the subjects perceived the uninterrupted sinusoidal alternating currents with a frequency range between 10 KHz and 50 KHz as more comfortable currents than the TENS. Although in the first the current density applied was higher.
权利要求:
Claims (4)
[1]
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1. Electric current generating device for use in the treatment of motor disorders, sensory disorders and pain, comprising at least one current intensity selector, one milliammeter and terminal terminals for electrical current output, characterized in that the current generated by The device is uninterrupted, with a frequency between 10 and 50 KHz, with a pulse width between 20 and 100 gs and with a current intensity between 1 and 200 mA.
[2]
2. Device according to claim 1, characterized in that it comprises an indicator of impedance or cutaneous resistance.
[3]
3. Device according to claim 1 or 2, characterized in that the alternating current waveform is sinusoidal or rectangular.
[4]
4. Device according to any of claims 1 to 3, characterized in that the motor disorder is spasticity, distomas or tremors.
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引用文献:
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US20120035683A1|2004-07-09|2012-02-09|Simon Bruce J|Method for treating degenerative disc disease using noninvasive capacitively coupled electrical stimulation device|
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US20130066411A1|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|
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US20150005852A1|2013-06-28|2015-01-01|Boston Scientific Neuromodulation Corporation|Transcutaneous electrical stimulation for treating neurological disorders|
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申请号 | 申请日 | 专利标题
ES201630168A|ES2629902B1|2016-02-15|2016-02-15|GENERATOR DEVICE FOR ELECTRICAL CURRENTS FOR USE IN THE TREATMENT OF MOTOR DISORDERS, SENSITIVE DISORDERS AND PAIN|ES201630168A| ES2629902B1|2016-02-15|2016-02-15|GENERATOR DEVICE FOR ELECTRICAL CURRENTS FOR USE IN THE TREATMENT OF MOTOR DISORDERS, SENSITIVE DISORDERS AND PAIN|
PCT/ES2017/070080| WO2017140932A1|2016-02-15|2017-02-13|Electric current generating device for use in the treatment of motor disorders, sensory disorders and pain|
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