EP3277367A1 - Dispositif de délivrance d'un courant continu à application thérapeutique comprenant une pluralité de structures plates - Google Patents

Dispositif de délivrance d'un courant continu à application thérapeutique comprenant une pluralité de structures plates

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Publication number
EP3277367A1
EP3277367A1 EP16719006.5A EP16719006A EP3277367A1 EP 3277367 A1 EP3277367 A1 EP 3277367A1 EP 16719006 A EP16719006 A EP 16719006A EP 3277367 A1 EP3277367 A1 EP 3277367A1
Authority
EP
European Patent Office
Prior art keywords
polygon
electrode
centers
current
structures
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Withdrawn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
EP16719006.5A
Other languages
German (de)
English (en)
Inventor
Albrecht Molsberger
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.)
Individual
Original Assignee
Individual
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Filing date
Publication date
Application filed by Individual filed Critical Individual
Publication of EP3277367A1 publication Critical patent/EP3277367A1/fr
Withdrawn legal-status Critical Current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
    • A61N1/02—Details
    • A61N1/04—Electrodes
    • A61N1/0404—Electrodes for external use
    • A61N1/0472—Structure-related aspects
    • A61N1/0476—Array electrodes (including any electrode arrangement with more than one electrode for at least one of the polarities)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/02—Details
    • A61N1/04—Electrodes
    • A61N1/0404—Electrodes for external use
    • A61N1/0408—Use-related aspects
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/02—Details
    • A61N1/04—Electrodes
    • A61N1/05—Electrodes for implantation or insertion into the body, e.g. heart electrode
    • A61N1/0502—Skin piercing electrodes
    • 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
    • A61N1/20—Applying electric currents by contact electrodes continuous direct currents
    • 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
    • A61N1/20—Applying electric currents by contact electrodes continuous direct currents
    • A61N1/205—Applying electric currents by contact electrodes continuous direct currents for promoting a biological process

Definitions

  • the present invention relates to a device for delivering direct current.
  • the DC delivery device according to the invention can be used for the therapeutic or cosmetic treatment of the human or animal body.
  • the present invention is also directed to the DC delivery device for specific use in certain methods of therapeutic treatment of the human or animal body.
  • the DC delivery device according to the invention is particularly suitable for the treatment of pain or allergy.
  • the invention also relates to a method for producing the DC output device.
  • a medically relevant impairment is in diseases or disorders of the function of the body. In these cases, a therapeutic treatment is generally indicated.
  • irritable conditions which in the context of the present invention means relatively minor impairments or discomforts of the human or animal body,
  • CONFIRMATION COPY which do not represent a disease or dysfunction and which are not therapeutic, often at least a cosmetic, non-therapeutic treatment is useful.
  • the present invention relates to the creation of new therapeutic options for (predominantly local) medically relevant impairments of the human or animal body as well as the non-therapeutic cosmetic treatment of (mainly local) irritation caused cosmetic impairments.
  • “therapy” also includes prophylaxis.
  • “Local” means that a specific area of the medically relevant impairment or of the stimulus state is detectable on or in the body.This area is preferably localized and preferably exactly identifiable. Area with Allergiesymptomatik) is associated with certain symptoms and is associated with the complaints or the impairment.
  • Cluster headache (Bing-Horton neuralgia) is a rare condition with extreme and unbearable headaches. These occur in violent unilateral attacks localized in the area of the temple and eye, in most patients always on the same side and typically resolve spontaneously after a quarter of an hour to several hours. The attacks occur periodically frequently with different length remission phases. The cause of the cluster headache is not clear.
  • Various variants of acute treatment e.g., oxygen inhalation, triptans, lidocaine
  • preventative treatment e.g., verapamil, corticosteroids
  • Allergic rhinitis is an allergic inflammation of the nasal mucosa, which is regularly associated with other respiratory diseases, such as conjunctivitis, sinusitis or asthma. Allergic rhinitis includes seasonal allergic rhinitis (hay fever), perennial allergic rhinitis (house dust allergy, ie house dust mite allergy) and occupational allergic rhinitis. An allergic rhinitis greatly affects the quality of life of the affected patients, for example due to sleep disorders and reduced concentration and / or performance, or due to the need to avoid the allergen in question. The incidence of such diseases has risen sharply in developed countries in recent decades, occasionally explained by malfunction of immune mechanisms originally designed to ward off parasites and under-utilized by improved hygiene.
  • Endogenous physiological electric fields are known in biology. Such fields are in the range of 70 mV / mm (chick nerve growth), 140 mV / mm (wound healing in rats), 600 mV / mm (vertebrate eye lens) to 1500 mV / mm (development of the neuronal tube in Lurch Axolotl). Depending on the internal resistance of the biological tissue in question, currents of 10-200 ⁇ result. Endogenous electric fields build up for a period of hours to weeks, for example in the wound area, in the area of active cell growth and in cell migration and appear to be essential for the regulation of cell behavior.
  • exogenous electrical fields in medicine and cosmetics is basically known.
  • strong and / or time-varying fields the temporal variability is caused for example by AC voltage or short DC voltage pulses.
  • These hitherto therapeutically used strong electric fields are generated for example by high voltages and regularly by strong currents.
  • AC and pulse current devices are used to counteract electrolytic effects on the electrodes used and in particular on the body tissue.
  • transcutaneous electrical nerve stimulation (TENS) is known.
  • Low-frequency (1-100 Hz) biphasic AC pulses are used for pain relief, primarily for short-term “electroanalgesia"
  • Voltage is up to 70 V at about 250 ⁇ pulse duration, the current up to about 90 mA.
  • the effect is based primarily on an increase in the central secretion of endorphins. It is unclear whether local and longer-term effects are also achieved in the affected tissue.
  • electroacupuncture Also known is the electroacupuncture. Their Wirkmechariismus aims at the release of central analgesic substances, in particular of enkephalins, endorphins and dynorphins. As described in the document US 2004/0111128 A1, also the electro-acupuncture uses alternating currents. In electroacupuncture, a low-frequency stimulation current is set (acupuncture textbook and Atlas von Stux, Stiller & Pomeranz, third edition, Springer-Verlag, 1989, p. 3), in which the frequency of the electrical signal is fixed or variable (2-10,000 Hz ). As with TENS, relatively strong currents of between 2 and 15 mA are used. These can only be pulsed at this intensity with a pulse duration of approx. 0.3 - 0.6 ms.
  • the electrical parameters in electroacupuncture include frequency and intensity (see one available on the website http://www.icmart.org/) and from a Congress of the International Council on
  • the stimulation dose is often uncontrollable.
  • DC is also used for transcutaneous transport of ionizable drugs (iontophoresis). Voltages of about 36-60 V and currents of about 10-30 mA are used. In order to avoid local tissue damage and a high
  • alternating currents and pulsed direct currents of a very low current intensity of maximum 900 ⁇ and a frequency of 0.1 to 999 Hz are applied via skin adhesive electrodes.
  • the indications are pain disorders of the musculoskeletal system.
  • tDCS transcranial direct current stimulation
  • the present invention is based on the technical problem of providing novel means and methods with which impairments of the human or animal body can be alleviated or eliminated, preferably pain (in particular headache such as cluster headache, migraine headache or tension-type headache) and / or allergies (especially allergic rhinitis such as seasonal allergic rhinitis, house dust mite allergy, animal hair allergy or allergic
  • the agents of the present invention allow for a more effective, safer, more reproducible, simpler, faster, less burdensome and / or less severe application, have a more rapid and / or longer term effect than the prior art agents and methods
  • a DC output device comprising a DC power source or means for connection to a DC power source and a planar first electrode and a planar second electrode for connecting (preferably: connected) to the DC power source, the first (1) each of the centers of the sheets of the first electrode has a distance of 15 cm or less ("maximum distance") to at least one other such center and / or where (2) is one of the following Alternatives are: (i) all centers of the sheets of the first electrode are arranged in a polygon (ie in the form of a polygon) in which the ratio of the maximum side length to the minimum side length is 3 or less, (ii) a part of the centers of the planar structure of the first electrode is in egg arranged such a polygon, the remaining part of the center is outside the Polygons, and when projected into a plane chosen such that the sum of the pitch squares of the polygon corners from the plane is minimal, each out of polygon center has at least one polygon intersecting connection line to
  • the electrode is arranged in such a polygon, the remainder of the centers is arranged outside the polygon, at least one connecting line of two centers is parallel to at least one side line of the polygon, and when projected into the said plane, no center outside the polygon has one the polygon intersecting connecting line with another center outside the polygon.
  • the "polygon” is either planar (all vertices lie in one plane) or nonplanar (not all vertices lie in a plane.)
  • the polygonal corners are formed by centers of the planar structures of the first electrode.
  • a "center” of the planar structure is preferably the center of gravity of the planar geometric shape of the structure
  • the above-described plane is selected using the known method of least squares In a planar polygon, this plane is identical to the plane of the polygon.
  • this arrangement serves to describe the arrangement of the two-dimensional structures and, as a rule, converts them into a three-dimensional arrangement for simplifying the description the first electrode) requires that, when viewed perpendicularly to the triangle, one connecting the two points
  • a "connecting line" of two points is the shortest link between these two points, which is a straight line delimited by these two points, that is, geometrically a distance.
  • outside of the polygon refers to the case where the midpoints are not part of the polygon and, moreover, such centers are not within the area enclosed by the polygon.
  • an "adhesive electrode” is understood to mean a planar electrode which can be applied to the skin surface (optionally depilated) and fixable there (preferably using a conductivity-imparting or improving additive material, such as electrode gel or electrode paste), in particular by sticking.
  • the planar first electrode consists of a plurality of planar structures, which are sometimes referred to individually as “pedes” for the purposes of the present application. "Areally” is preferably defined as a planar and / or uniform configuration of the surface. alternatively, at least one substantially planar and / or uniform
  • flat excludes an embodiment of the surface as a grid, wire, tube, pin or similar structures.
  • DC current is understood as meaning an electric current whose direction does not change and whose time-average current does not essentially change under the same conditions.
  • the direct current is a "pure” DC current whose current strength substantially or not at all under constant conditions changes.
  • certain variations over time are also possible, in particular a “swinging" direct current, in which the current periodically fluctuates around a certain mean value without, however, changing the direction of current
  • the undulation is preferably carried out with a frequency between 0.001 and 10 Hz, in particular between 0.01 and 1 Hz, for example 0.1 Hz.
  • the deflection of the DC current is 50% of the previously set value (ie the values are between 150% and 50% of the previously set value), in particular 40%, 30%, 20%, 15%, 10%, 7.5%, 5 %, 2.5% or 1%
  • the present invention is based on the discovery that low direct current attenuates the mentioned medical or cosmetically relevant impairments and effects In particular, pain and allergies can be improved effectively if it acts on the body via a flat electrode with a plurality of planar structures (pads) in a local electric DC field.
  • the inventive DC delivery device is a surprising
  • the present invention plurality of flat structures allows it to include the area of medically relevant impairment or stimulus state between the planar structures include or orbiting and so to achieve a local influence of the direct current.
  • the arrangement in a polygon of the described geometry allows to rewrite certain body parts (eg the nose) in such a way that it achieves this surprising effectiveness in the treatment.
  • the optionally located outside the polygon (centers of) the flat structures of the first electrode make it possible to treat other parts of the body with DC (eg, places near the eyes, such as the temples) and so the effectiveness of the
  • Treatment for example, because it is not necessary to stick needles through the skin.
  • Such a treatment is also easy to implement and allows, for example, a quick and easy home use. This is especially beneficial for pain that occurs in attacks and generally for chronic discomfort and discomfort, where it can not be ruled out that the treatment must be repeated.
  • the use and thus the side effects of pharmaceutical agents can be reduced or even avoided.
  • the maximum distance described above is preferably 14 cm, 13 cm, 12 cm, 11 cm, 10 cm, 9.5 cm, 9 cm, 8.5 cm, 8 cm, 7.5 cm, 7 cm, 6.5 cm, 6 cm, 5.5 cm, 5 cm, 4.5 cm, 4 cm and especially 3.5 cm.
  • each of the centers of the planar structures of the first electrode has the relevant maximum distance to at least two or in particular at least three further such centers.
  • each of the centers of the planar structures of the first electrode has a distance of 0.5 cm or more from all other such centers ("minimum distance").
  • minimum distance 1 cm, 1.5 cm, 2 cm, 2 is preferred , 5 cm and especially 3 cm.
  • Preferred combinations of minimum distance and maximum distance are 0.5 and 15 cm, 1 and 12 cm, 1, 5 and 10 cm, 2 and 8 cm, 2.5 and 6 cm, 3 and 5 cm, 3 and 4 cm and 3 and 3,5 cm.
  • the ratio of the maximum side length to the minimum side length be 2.8 or less, 2.6 or smaller, 2.4 or smaller, 2.2 or smaller, 2 or smaller, 1, 9 or smaller, 1, 8 or less, 1, 7 or less, 1, 6 or less, 1, 5 or less, 1, 4 or less, 1, 3 or less, 1, 25 or less, and particularly preferably 1, 2 or is smaller.
  • the ratio of the maximum page length to the minimum page length may also be 1, 15 or less, 1, 1 or less, 1, 05 or less, or even 1 (all page lengths are equal).
  • the polygon described above preferably has (at least) one axis of symmetry.
  • arranged outside the polygon centers of the planar structures of the first electrode are preferably arranged symmetrically to an axis of symmetry of the polygon.
  • the polygon is an octagon, heptagon, hexagon, pentagon, quadrilateral and in particular a triangle.
  • an even number of centers of the planar structures of the first electrode is outside the polygon.
  • exactly two of the centers of the two-dimensional structures of the first electrode lie outside the polygon, in particular if the polygon is a triangle.
  • each of the centers of the sheets of the first electrode defines a vertex of the polygon.
  • a center of a planar structure of the first electrode is arranged only on one side of the polygon.
  • not all angles of the polygon are the same.
  • a DC current delivery device is preferred in which at least one connecting line of two center points of the two-dimensional structures of the first Electrode is parallel to at least one connecting line of two other such centers.
  • the number of planar structures of the first electrode is 3 or greater, for example 4 or 5.
  • a preferred number of the sheets of the first electrode is 9 or less, for example 8, 7 or 6.
  • Preferred ranges for the number of sheets of the first electrode are, for example, 3 to 9, 3 to 7, 5 to 7 and 3 to 5.
  • the area of one, several, or in particular of all planar structures of the first electrode is in each case in the range from 1 to 10 cm 2 , preferably 2 to 8 cm 2 , 3 to 7 cm 2 , 3 to 5 cm 2, and in particular about 5 cm 2 .
  • the surfaces of the flat structures of the first electrode are identical.
  • the second electrode preferably has a larger area than a sheet of the first electrode or even a larger area than the total area of the first electrode.
  • Preferred sizes of the second electrode are 25 cm 2 to 200 cm 2 , in particular 50 cm 2 to 100 cm 2 .
  • the current intensity of the direct current at the planar structures of the first electrode divided by the number of these flat structures is 100 to 1000 ⁇ .
  • the current intensity per Päd is preferably 100 to 1000 ⁇ , without, however, necessarily implying an individual stabilization of the current intensity at each individual Päd. It is therefore already sufficient if the total amount of current attributable to the pads is set according to the number of pads, that is, for example, preferably 300 to 3000 ⁇ for three pads.
  • the applied electric field according to the invention is preferably of the order of endogenous and physiological electric fields. Further preferred current strengths of the direct current at the planar structures of the first electrode divided by the number of these planar structures are 150 to 750 ⁇ , 200 to 500 ⁇ , 250 to 400 ⁇ and in particular 300 ⁇ .
  • the first electrode has a different polarity than the second electrode.
  • the first electrode is formed as a cathode.
  • the DC current delivery device improves or eliminates cosmetically or medically relevant impairments and makes it possible for the body to suffer. These are preferably pain and / or allergies.
  • the use of exogenous pharmaceutical agents or drugs can be reduced or completely avoided. As a result, the undesirable side effects of such substances occur to a reduced degree or not at all.
  • the impairments and complaints are permanently or at least in the long term alleviated or eliminated or prevented with the use of the DC delivery device according to the invention. By repeating the application, the effect can often be increased to permanent freedom from the impairments.
  • the use of the DC delivery device according to the invention is low-risk, effective and poor or free of side effects. The effect occurs quickly and predictably.
  • the delivered current dose is precisely controllable. It is also advantageous that, according to the invention, a regeneration of tissue damaged by chronic inflammation or degenerative processes is also permitted. The effectiveness against
  • Pain is inventively much better than, for example, in the electroacupuncture as described above.
  • the DC delivery device When used on a human or animal body, the DC delivery device according to the invention has, in particular, an anti-allergic and analgesic action which is advantageous, for example, in the treatment of (in particular local) pain or allergies.
  • Treatable are, for example, headache (in particular cluster headache, migraine headache or tension-type headache) or allergic rhinitis (in particular seasonal allergic rhinitis, ie hay fever, house-dust mite allergy, animal hair allergy or allergic asthma).
  • human or animal bodies of patients can be treated with the DC delivery device according to the invention.
  • patient is not meant to be limiting to a therapeutic treatment, but also covers a cosmetic treatment, and preferred patients are mammals such as horses, dogs, cats or camels, and especially humans.
  • the painful area affected by the allergic reaction is first localized.
  • a plurality of flat structures are positioned there as described above and electrically connected to one another.
  • the two-dimensional structures are connected as a first electrode (planar electrode) to a pole, preferably the negative pole of the DC power source.
  • the other pole is connected to the second electrode, which is preferably a surface adhesive electrode in another area of the body.
  • Such a surface electrode is preferably placed over large muscle groups or layers of fat so that individual nerves are not irritated by the surface electrode.
  • a preferably constant current is applied for treatment.
  • the pain or allergic symptoms diminish from about 2 hours to 2 days after treatment, usually the following day.
  • the therapy duration of a session is between 15 and 60 minutes. As a rule, 2 to 4 sessions are held, in some cases more.
  • a particularly good reproducible effect can be achieved if the current is kept constant.
  • the current determines the strength of the electric field in the tissue. At constant current level (as opposed to, for example, setting a constant voltage), any variations in resistance can not be present.
  • the DC output device (as described above) comprises a means for keeping constant the current during the delivery of the direct current (in particular in the case of a change in a resistance between the electrodes).
  • This means is designed to keep constant the current during the delivery of the DC current, in particular when the voltage applied between the electrodes changes resistance. Without such an agent, there is often the situation that the electrical resistance of the body tissue (such as the skin) changes during the treatment and the current then fluctuates.
  • Amperage due to an individually different resistance between skin and tissue which is usually in the range of 3 to 100 kü, in different individuals different currents are observable and thereby vary the treatment successes to some extent.
  • the consistent treatment success is achieved independently of the individually different resistance between skin and tissue.
  • the DC output device therefore preferably comprises an automated means for keeping the current constant constant Delivering the direct current (especially in the case of changing a voltage applied between the electrodes resistance).
  • the current output by an individual driver of the first electrode is referred to as "single current”.
  • Amperage of the direct current is kept constant, but the respective current in the individual delivery of direct current through flat structures of the first electrode is kept constant.
  • the respective pads of the first electrode then output a constant current (preferably each one of the pads), and not only the entire first electrode as a whole.
  • one or more means are provided for respectively keeping the current level of the direct current output from the individual pad of the first electrode constant, thereby producing a multi-channel device.
  • each individual channel i. the current intensity of the individual pads of the first electrode are kept constant.
  • the DC output device comprises one or more means for respectively keeping the individual current intensities constant.
  • a DC output device has individually adjustable and controllable circuits.
  • each ped of the first electrode is in each case electrically conductively connected to a series resistor.
  • the series resistors are in this case means for respectively keeping constant the current intensity in the individual delivery of direct current through flat structures of the first electrode.
  • Series resistors have a resistance of 10 kU to 100 kQ, 15 kQ to 80 kQ, 20 kQ to 60 kQ, 25 kQ to 40 kQ and especially 30 kQ.
  • the series resistors are preferably sufficient to make variations in skin resistance insignificant by comparison. It is immutable or variable resistors can be used.
  • Resistive resistors may be combined with one or more other means described herein for respectively maintaining the current constant in the individual delivery of direct current through the pad (s) of the first electrode, but may also be used in the absence of such other means.
  • Series resistors may alternatively be combined with a means for keeping the total current constant in the delivery of the direct current, or else in
  • the individual currents can be identical or different.
  • the individual current strengths are preferably identical, in particular in the time average, or else the factor which results by dividing the largest single current intensity by the smallest single current intensity, in particular in the time average, is not greater than 2, 1, 9, 1, 8, 1, 7 , 1, 6, 1, 5, 1, 4, 1, 3, 1, 25, 1, 2, 1, 18, 1, 15, 1, 12, 1,1, 1, 08 or 1, 05.
  • different individual current strengths may be preferred; For such cases, it is advantageous if the individual currents are individually adjustable.
  • the fluctuation of a single current intensity about its constant value is at most 50% of the constant value, advantageously at most 40%, 30%, 25%, 20%, 15%, 12%, 10%, 9%, 8%, 7%, 6 %, 5%, 4%, 3%, 2% or 1%. This is preferably the case for all individual current strengths.
  • the electrical resistance R in the treatment is primarily determined by the contact of the electrodes with the skin and possibly the immediate environment of the flat structures. Often the resistance changes during the course of treatment. In order nevertheless to ensure a constant current intensity I, there are, inter alia, the possibilities of changing the contact surface between electrodes and body tissue, for example by changing the contact pressure of the second electrode, or by changing an internal resistance of the DC output device according to the invention.
  • the resistance of the skin can also be reduced by prolonged moistening of the skin and / or by warming the skin (for example by an infrared lamp).
  • the DC output device optionally comprises a variable internal resistance for adjusting the output current.
  • a constancy of the current I is ensured by corresponding change in the voltage U.
  • a preferred means for keeping the current constant in the DC output device according to the invention is formed automatically.
  • this is a regulator, which may be constructed for example of analog components or as an integrated circuit.
  • a regulator preferably comprises a means for measuring the actual current intensity (for example in the supply line to the first electrode), a means for determining a deviation from a predetermined desired current intensity and a means for adjusting a correction of the voltage U corresponding to the deviation, in particular proportional to the deviation (proportional controller).
  • Preferred DC sources according to the invention are, for example, batteries.
  • battery in addition to batteries with a voltage of preferably 1, 2 V (about nickel metal hydride batteries) to 1, 5 V (about alkali-manganese or zinc-carbon batteries), alone or in preferably two-, three- or four-fold design connected in series) also accumulators and galvanic cells.
  • a preferred battery has a voltage of 1, 2 to 1, 5 V and is alone or in preferably two-, three- or four-fold execution in succession
  • batteries are used in the absence of direct current continuity means to deliver a particularly simple yet effective DC output device, but batteries may alternatively be used in conjunction with a current continuity means
  • Further DC sources which are preferred according to the invention are networks ile or constant current sources.
  • a particularly preferred DC power source is included, for example, in the device marketed by neuroConn GmbH (Ilmenau, Germany) under the name "DC Stimulator.”
  • This device is used in the prior art for transcranial direct current stimulation (tDCS) of the brain Means for keeping the current constant and is offered in a kit together with two sponge electrodes for placement on the head for transcranial direct current stimulation.
  • the electrical voltage when using the DC delivery device for the treatment of the human or animal body is preferably at most 24 V, 20 V, 18 V, 16 V, 14 V, 13 V, 12 V, 11 V, 10 V, 9 V, 8 V, 6V 4.8V, 4.5V, 3.6V, 3
  • the DC output device preferably comprises a (in particular remotely controllable) means for setting a maximum voltage. Furthermore, it preferably comprises a (in particular remotely controllable) means for setting a maximum charge.
  • the DC output device further comprises a timing means, with which a plurality of periods for delivering the DC current can be predetermined.
  • this is an electronic switchable interruption of the electrically conductive connection between cathode, DC source and anode.
  • the timing means is associated with a minimum period setting means, the latter preferably permitting determination of a minimum period of 1 second, 10 seconds, 1 minute, 2 minutes, 5 minutes, 10 minutes, 20 minutes or 30 minutes ,
  • the means for timing control is remotely controllable.
  • the means for timing further with a (preferably remotely controllable) means for Determining a maximum period linked, the latter preferably allows a determination of a maximum period of 2 h, 1 h, 50 min, 40 min, 30 min, 20 min, 10 min, 5 min or 2 min.
  • the DC output device comprises a (in particular remotely controllable) means for emergence and leakage (ramping) of the current.
  • a (in particular remotely controllable) means for emergence and leakage (ramping) of the current At the beginning of the treatment, such an agent allows the current intensity to increase from zero to the desired value within a predeterminable time period (with a preferred length of 1-60 seconds, more preferably 5-45 seconds and especially 10-30 seconds) and at the end of the treatment a drop from the setpoint to zero within a predeterminable time period (with a preferred length of 1-60 seconds, more preferably 5-45 seconds, more preferably 10-30 seconds and especially 15 seconds).
  • a slow emergence and leakage of the current is advantageous because otherwise - in the sudden turn on or off of the stream - the treated individual feels an unpleasant twitch or electric shock.
  • the DC output device comprises means (preferably remotely controllable) for switching the polarity of the electrodes during a treatment.
  • This is preferably associated with a means for timing, so that it is possible, for example, the polarity every second, every 10 s, every minute, every 2 minutes, every 5 minutes or every 10 minutes to switch.
  • the DC output device is optionally adjustable to a test mode in which a constant voltage of about 1-8V, 2-6V, or 3-5V is delivered. This can be used to check whether the electrodes are electrically correctly coupled or not, or whether there is an occult cable break in any cable.
  • the DC dispenser includes a buzzer (such as a tone generator) that indicates when a correct current flow is occurring. From an absence of the signal can be concluded that the coupler chain is interrupted.
  • a signal generator may also be used to indicate the beginning and / or the end of the treatment. Further, a signal generator is preferably used to indicate if during a treatment, the current flow is interrupted or the impedance of the patient is too high, in particular in combination with a shutdown.
  • the DC output device of the present invention is adapted to deliver pulsed DC at a frequency of 1 Hz or less, or to a continuous current (ie non-pulsed DC) output.
  • the first electrode further comprises, ie adjacent to the planar structures, one or more needles, preferably 3 to 12, 4 to 10, 6 to 10, 6 to 8 and in particular 8.
  • a needle is an elongated (preferably cylindrical)
  • a needle has a pointed end, in particular a conically pointed one
  • a needle is preferably designed in such a way that its application does not injure the human or animal body
  • the diameter of a region to be inserted is (excluding a tapered end) preferably between 0.1 and 0.8 mm, preferably between 0.2 and 0.4 mm and in particular about 0.3 mm, wherein a insectstchende area preferably also has a tapered end; the length of a region to be inserted is preferably between 10 and 100 mm, preferably between 20 and 50 mm and in particular about 30 mm
  • Eesser in a grip area for example, be about 1-3 mm.
  • Preferred needles are in the form of known acupuncture needles and have the following dimensions: 0.2 ⁇ 15 mm, 0.25 ⁇ 40 mm, 0.3 ⁇ 30 mm, 0.3 ⁇ 100 mm, 0.35 ⁇ 50 mm and 0, 35 x 100 mm.
  • the material of a needle is preferably metal.
  • Preferred metals are stainless steels, ie unalloyed or alloyed steels with low sulfur and phosphorus content. Further alloying components are preferably chromium (preferably in a proportion of 10.5-13 wt.% Or higher), nickel (preferably in a small amount
  • Proportion about a maximum of 10% by weight
  • molybdenum titanium and / or niobium.
  • Preferred is 18/10 chromium-nickel steel or medical grade stainless steel.
  • Preferred steels are those which are resistant to water and weak organic and inorganic acids.
  • Especially preferred are stainless steels.
  • Other preferred metals are silver, gold and platinum.
  • the needles are merely silver plated, gold plated or platinum plated. Preference is also given to sintered materials, for example of silver / silver chloride.
  • the needle (s) optionally inserted next to the planar structures of the first electrode is / are preferably arranged outside a region circumscribed by the planar structures.
  • the first electrode comprises one or more needles in addition to the planar structures
  • the electrode is then preferably 10 to 100 ⁇ , preferably 15 to 80 ⁇ , 20 to 60 ⁇ , 25 to 50 ⁇ and 25 to 40 ⁇ , and in particular 30 ⁇ .
  • a particularly preferred DC output device is designed as follows, that is to say has a sum of features which are already preferred on their own in each case: the first electrode consists of a plurality of flats. chige structures.
  • the polygon is a triangle with an axis of symmetry.
  • two centers of planar structures of the first electrode are arranged outside the triangle, which are arranged symmetrically to the symmetry axis of the triangle.
  • the current intensity of the direct current divided by the number of planar structures of the first electrode is 100 to 1000 ⁇ and in particular 300 ⁇ .
  • the first electrode is formed as a cathode.
  • the area of all planar structures of the first electrode is in each case in the range from 1 to 10 cm 2 and in particular 5 cm 2 .
  • the DC output device is adapted to a continuous current output.
  • the DC output device comprises means for automatically keeping the current constant when delivering the DC current.
  • the first electrode comprises several needles, but not in the treatment of seasonal allergic rhinitis (hay fever).
  • the present invention also relates to the DC delivery device according to the invention (as described above, in particular in one or more of the preferred embodiments) for use in the treatment of pain (preferably headache, in particular cluster headache, migraine headache or tension-type headache) or an allergy (preferably allergic rhinitis, in particular seasonal allergic rhinitis, house dust mite allergy, animal hair allergy or allergic asthma).
  • pain preferably headache, in particular cluster headache, migraine headache or tension-type headache
  • an allergy preferably allergic rhinitis, in particular seasonal allergic rhinitis, house dust mite allergy, animal hair allergy or allergic asthma.
  • the subject of the second aspect of the present invention is also the use of such a DC delivery device according to the invention in the treatment of pain (preferably headache, in particular cluster headache, migraine headache or tension-type headache) or a
  • Allergy preferably allergic rhinitis, especially seasonal allergic rhinitis, house dust mite allergy, animal hair allergy or allergic asthma
  • a DC delivery device according to the invention for the manufacture of a therapeutic device for use in the treatment of pain (preferably headache, especially cluster headache,
  • the second aspect of the present invention relates to a method of treating pain (preferably headache, especially cluster headache, migraine headache or tension-type headache) or allergy (preferably allergic rhinitis, especially seasonal allergic rhinitis, house dust mite allergy, pet allergy or allergic asthma) of a patient which requires such treatment, comprising exposing the patient to the body of the DC dispenser according to the invention.
  • a third aspect of the present invention relates to the use of the DC delivery device according to the invention (as described above, in particular in one or more of the preferred embodiments) for the cosmetic treatment of the human or animal body.
  • the present invention also relates to a method for producing a DC output device, preferably as described above (in particular in one or more of the preferred embodiments), comprising the following steps:
  • each of the centers of the sheets of the first electrode has a distance of 15 cm or less to at least one other such center and / or (2) one of the following alternatives is true: (i) all centers of the sheets of the first electrode are arranged in a polygon in which the ratio of the maximum side length to the minimum side length is 3 or smaller, (ii) a part of the centers of the sheets of the first electrode is in one arranged such polygon, the remaining part of the centers is arranged outside the polygon, and when projected in a plane which is chosen so that the sum of the square of the squares
  • Polygon corner of the plane is minimum, each center located outside the polygon has at least one connecting line crossing the polygon with another center outside the polygon, or (iii) a part of the centers of the planar structures of the first electrode is arranged in such a polygon , the remaining part of the
  • Midpoints are located outside the polygon, at least one connecting line of two centers is parallel to at least one side line of the polygon, and when projected into said plane, no outside of the polygon has a connecting line intersecting the polygon with another point outside the polygon on and
  • NSM treatment with direct current with constant current.
  • Example 2 pain patient, 56 years. CK diagnosed since 2002, always on the right, 2 years of diagnosis, last episode in 7 months, more than 1 year 4 weeks CK-free. Before episode duration 3-7 months. CK 2-3 / day, duration 20-30 min with oxygen 10 liters, 90 min. Pain intensity VAS 7-10. Sumatriptan Tbl. Cortisone does not help last. Verapamil 480 mg / day. 2008-2010 unbearable pain that does not respond to 0 2 - suicidal. NSM stimulation 11 needles 0.25 mm, 440 ⁇ each. Puncture at the acupuncture points Gb 21, Bl 10, Taiyang, Gb2. Local anesthesia.
  • Adhesive pads two pads middle forehead (directly adjacent). Stimulation of the pads with a total of 600 ⁇ . Additionally 4 needles 0.25 mm back of the head stimulated with 20 ⁇ per needle. Under this therapy modification immediate improvement to the complaint after the seventh treatment. After the treatments with pads no rebound attacks occur.
  • Example 5 Allergy patient 58 years: For more than 20 years known hay fever. Every 2 years to

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Abstract

La présente invention concerne un dispositif de délivrance de courant continu comprenant une source de courant continu ou un dispositif de raccordement à une source de courant continu, et une première électrode plate ainsi qu'une seconde électrode plate destinées à être reliées à la source de courant continu. La première électrode comprend une pluralité de structures plates et (1) chacun des points centraux de la structure plate de la première électrode se trouve à une distance de 15 cm ou moins d'au moins un autre de ces points centraux et/ou (2) on a une des variantes suivantes : (i) tous les points centraux de la structure plane de la première électrode sont disposés selon un polygone dans lequel le rapport de la longueur de côté maximale à la longueur de côté minimale de 3 est plus petit, ou (ii) une partie des points centraux de la structure plane de la première électrode est disposée selon un tel polygone, la partie restante des points centraux est disposée à l'extérieur du polygone, et en projection dans un plan qui est choisi de telle sorte que la somme des carrés des distances des angles du polygone au plan est minimale, chaque point central situé à l'extérieur du polygone comporte au moins une ligne de liaison qui coupe le polygone et qui comporte un autre point central situé à l'extérieur du polygone ou (iii) une partie des points centraux de la structure plane de la première électrode est disposée dans un tel polygone, la partie restante des points centraux est disposée à l'extérieur du polygone, au moins une ligne de liaison de deux points centraux est parallèle à au moins une ligne de côté du polygone, et en une projection dans ledit plan aucun point central situé à l'extérieur du polygone ne comporte une ligne de liaison ayant un autre point central situé à l'extérieur du polygone.
EP16719006.5A 2015-03-28 2016-03-29 Dispositif de délivrance d'un courant continu à application thérapeutique comprenant une pluralité de structures plates Withdrawn EP3277367A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE102015004064.2A DE102015004064A1 (de) 2015-03-28 2015-03-28 Therapeutisch anwendbare Gleichstromabgabevorrichtung mit einer Mehrzahl flächiger Gebilde
PCT/EP2016/000525 WO2016155878A1 (fr) 2015-03-28 2016-03-29 Dispositif de délivrance d'un courant continu à application thérapeutique comprenant une pluralité de structures plates

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EP3277367A1 true EP3277367A1 (fr) 2018-02-07

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US (1) US20180117300A1 (fr)
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US4641656A (en) * 1985-06-20 1987-02-10 Medtronic, Inc. Cardioversion and defibrillation lead method
DE4202119A1 (de) * 1991-09-12 1993-03-18 Eilentropp Heinz Vorrichtung zur medizinischen behandlung von koerperteilen
US5496362A (en) * 1992-11-24 1996-03-05 Cardiac Pacemakers, Inc. Implantable conformal coil patch electrode with multiple conductive elements for cardioversion and defibrillation
EP1011792B1 (fr) * 1997-02-26 2005-12-07 Alfred E. Mann Foundation for Scientific Research Dispositif implantable sur un patient et fonctionnant sur batterie
EP0970719A3 (fr) * 1998-07-08 2000-08-23 Nitto Denko Corporation Structure d'électrode
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ATE330574T1 (de) 2002-12-06 2006-07-15 Wei-Cheng Wang Computerunterstützes, automatisches system zum abgleich von vitalen akupunkturpunkten
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KR101749605B1 (ko) * 2009-10-05 2017-06-21 더 리젠트스 오브 더 유니이버시티 오브 캘리포니아 신경계통 이상증상 및 신경질환의 치료를 위한 시스템, 장치 및 방법
CN107376115A (zh) * 2011-11-15 2017-11-24 神经系统检测公司 用于使用经皮电神经刺激减轻疼痛的设备和方法
DE102012010262B4 (de) 2012-05-25 2014-07-03 Albrecht Molsberger Therapeutisch anwendbare Gleichstromabgabevorrichtung

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US20180117300A1 (en) 2018-05-03
WO2016155878A1 (fr) 2016-10-06

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