EP3277367A1

EP3277367A1 - Direct current applicator for therapeutic use, with a plurality of sheet-like structures

Info

Publication number: EP3277367A1
Application number: EP16719006.5A
Authority: EP
Inventors: Albrecht Molsberger
Original assignee: Individual
Current assignee: Individual
Priority date: 2015-03-28
Filing date: 2016-03-29
Publication date: 2018-02-07
Also published as: US20180117300A1; WO2016155878A1; DE102015004064A1

Abstract

The present invention relates to a direct current applicator comprising a direct current source, or a device for attachment to a direct current source, and a sheet-like first electrode and a sheet-like second electrode for connection to the direct current source, wherein the first electrode comprises a plurality of sheet-like structures, and wherein (1) each of the midpoints of the sheet-like structures of the first electrode has a distance of 15 cm or less from at least one other such midpoint, and/or (2) one of the following alternatives applies: (i) all midpoints of the sheet-like structures 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 less, (ii) some of the midpoints of the sheet-like structures of the first electrode are arranged in such a polygon, the remainder of the midpoints are arranged outside the polygon, and, on projection in a plane which is chosen such that the sum of the squares of the distance of the polygon corners from the plane is minimal, each midpoint lying outside the polygon has at least one connection line, intersecting the polygon, to another midpoint lying outside the polygon, or (iii) some of the midpoints of the sheet-like structures of the first electrode are arranged in such a polygon, the remainder of the midpoints are arranged outside the polygon, at least one connection line of two midpoints is parallel to at least one side line of the polygon, and, on projection in said plane, no midpoint lying outside the polygon has a connection line, intersecting the polygon, to another midpoint lying outside the polygon.

Description

"Therapeutically applicable DC delivery device with a plurality of flat structures"

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. Finally, the invention also relates to a method for producing the DC output device.

Many medical or cosmetically relevant impairments of the human or animal body are local. A medically relevant impairment is in diseases or disorders of the function of the body. In these cases, a therapeutic treatment is generally indicated. In the case of 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.

The term "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) and preventative treatment (e.g., verapamil, corticosteroids) are known. However, in some patients, none of these treatment options are adequately effective. Due to the enormous suffering of those affected further treatment options are urgently needed.

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. Acute treatment is possible, but many, including modern, medicines have part that they are tiring or have other significant side effects. Hyposensitization is tedious and requires good compliance and yet is not effective in all cases. 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 μΑ 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.

The use of exogenous electrical fields in medicine and cosmetics is basically known. Here are regularly used 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. In this context, AC and pulse current devices are used to counteract electrolytic effects on the electrodes used and in particular on the body tissue.

For example, 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 μβ 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.

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. In order to avoid electrolytic effects at the transition between the electrode and the biological tissue at these high currents, the polarity is changed (alternating current). Accordingly, the electrical parameters in electroacupuncture in each case include frequency and intensity (see one available on the website http://www.icmart.org/) and from a Congress of the International Council on

Medical Acupuncture and Related Techniques 1998 Summary on Electroacupuncture Parameters).

In summary, the known devices for TENS or electro-acupuncture circuitous consuming, they work with high currents, short pulses and

AC of certain frequencies. Regardless, the stimulation dose is often uncontrollable.

In tumor therapy, DC galvanotherapy with high currents of 60-80 mA at a voltage of 6-35 V is known. In this therapy, it should lead to a destruction of the tumor tissue, for example by necrosis. Destruction of tissue is therefore not an undesirable effect to avoid, but on the contrary expressly desired. The method uses the increased conductivity of tumor tissue in comparison to healthy tissue, so that the flow of current selectively concentrates in the tumor tissue and there the disintegration of the tumor tissue

Tumor by electrolytic and necrotizing effects.

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

To be able to transport the dose of active substances electrophoretically, large-area skin electrodes are placed on the skin.

Known and widespread is the micro current therapy. In this case, alternating currents and pulsed direct currents of a very low current intensity of maximum 900 μΑ and a frequency of 0.1 to 999 Hz are applied via skin adhesive electrodes. The indications are pain disorders of the musculoskeletal system.

Furthermore, an application of broad-area moist pulp electrodes on the scalp to stimulate the central nervous system is known, for example in tinnitus

(transcranial direct current stimulation, tDCS). In this case, a current of up to 1 mA and a voltage of 8-25 V at constant and pulsating current is used.

It is known that the corresponding electric fields generated by weak direct current promote vascular growth, inter alia via the secretion of VEGF and its influence on endothelial cells. They lead to a movement and Rearrangement of cell membrane receptors, increase the rate of division of certain cells and accelerate cell migration of epithelial cells. This cell migration occurs from the anode (away from the positive pole) and towards the cathode (towards the negative pole). In animal experiments there is evidence that the peripheral nerve regeneration after spinal cord trauma can be accelerated, the axons of nerve cells to

Cathode, which must be about three weeks headfirst. Clinical studies in humans indicate an acceleration of wound healing by electric fields. 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

Asthma).

The foregoing statements, as well as any description of exemplary embodiments contained herein, do not disclose particular embodiments or features.

Preferably, 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

Treatment of impairments that are not yet adequate or even untreatable with the prior art agents.

The technical problem is solved according to a first aspect of the present invention by 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 another out of polygon center , or (iii) a part of the centers of the two-dimensional formations of the first

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.

According to the invention, 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. For example, in the case of a triangle of said geometry and two points outside the triangle (center points of the flat structures), 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

Line the triangle intersects.

A "connecting line" of two points (for example, two such centers) is the shortest link between these two points, which is a straight line delimited by these two points, that is, geometrically a distance.

The term "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.

In the present case, 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. According to the invention, 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

Design. Preferably, "flat" excludes an embodiment of the surface as a grid, wire, tube, pin or similar structures.

The term "comprising" also includes the meaning "consisting of" and, in preferred embodiments, has the latter meaning except where the context dictates otherwise. The same applies to conceptual variants such as "include" and "consist of".

In the present case, "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.Preferably, the direct current is a "pure" DC current whose current strength substantially or not at all under constant conditions changes. However, 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. Preferably, it is rectangular, sawtooth and in particular sinusoidal 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. In particular, the inventive DC delivery device is a surprising

Effectiveness in headache (eg cluster headache) and allergic rhinitis (eg seasonal allergic rhinitis) allows. 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 continues to increase. The surprising effectiveness is also achieved when (centers of) the flat structures are in the maximum distance (as defined above) to each other. The publication WO 2013/175021 A1 discloses a DC output device that can be used with needle electrodes or flat electrodes. An arrangement of flat structures at a certain distance or in a specific geometry is not disclosed therein. The use of flat structures allows little or no stress

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.

Preferably, 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.

Preferably, 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"). A minimum distance of 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. In certain cases, especially in the treatment of pain, it is sometimes preferable to apply two pads directly next to each other without space between the pads or with a gap of at most a few millimeters to ver Ver the amount of current acting on the body at a certain point - double.

In the polygon described above, it is preferable that 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. In some cases, 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. In the alternative, in which only a part of the centers of the planar structures of the first electrode is arranged in a polygon with symmetry axis, 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. These features allow a particularly even, balanced and effective treatment.

Preferably, the polygon is an octagon, heptagon, hexagon, pentagon, quadrilateral and in particular a triangle. In the event that only a part of the centers of the planar structures of the first electrode are arranged in the polygon, it is preferred that an even number of centers of the planar structures of the first electrode is outside the polygon. Preferably, 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.

It is preferable that each of the centers of the sheets of the first electrode defines a vertex of the polygon. In other words, it is preferably excluded that a center of a planar structure of the first electrode is arranged only on one side of the polygon.

In a preferred embodiment, not all angles of the polygon are the same.

A DC current delivery device according to the invention 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.

Preferably, in the DC output device according to the invention, the number of planar structures of the first electrode is 3 or greater, for example 4 or 5.

Regardless, or preferably, simultaneously, 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.

Preferably, in the DC output device according to the invention, 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 .

Preferably, 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 effects already occur when the direct current is very weak. Preferably, 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 μΑ. In other words, the current intensity per Päd is preferably 100 to 1000 μΑ, 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 μΑ 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 μΑ, 200 to 500 μΑ, 250 to 400 μΑ and in particular 300 μΑ.

According to the invention, the first electrode has a different polarity than the second electrode. Preferably, the first electrode is formed as a cathode.

The DC current delivery device according to the invention improves or eliminates cosmetically or medically relevant impairments and makes it possible for the body to suffer. These are preferably pain and / or allergies. According to the invention, 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.

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).

According to the invention, human or animal bodies of patients can be treated with the DC delivery device according to the invention. The term "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.

In a typical course of treatment, the painful area affected by the allergic reaction is first localized. For example, 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. Typically, 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

Fluctuations in the current and in particular no current peaks cause. Interindividual differences in the resistance can not lead to different current intensities (in contrast to the setting of a constant voltage). It has been found that with a non-constant current, the treatment results achieved vary to a certain extent on a case-by-case basis, without, however, jeopardizing the fundamental success of the treatment.

Preferably, the DC output device according to the invention (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.

It is a recognition of the present invention that using a means for keeping the current constant, the result is particularly well reproducible. By means of such a constant current flow is ensured even with a changing resistance, thereby achieving a consistent treatment success. In addition, it has been found that without a means of keeping the

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. Using the means for keeping the current constant, the consistent treatment success is achieved independently of the individually different resistance between skin and tissue.

Keeping the current constant is preferably an automated constant. The DC output device according to the invention 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".

For certain applications it is advantageous (for example with regard to the reproducibility of the effect, the potency of the action, the speed of onset of action, the duration of the duration of the effect and / or the treatability of certain impairments or complaints), if not only the total

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. In other words, 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.

For such a case, 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. In this case, each individual channel, i. the current intensity of the individual pads of the first electrode are kept constant. A trained in this way

In other words, the DC output device comprises one or more means for respectively keeping the individual current intensities constant. In a preferred embodiment, such a DC output device has individually adjustable and controllable circuits. However, it may also be preferable to provide a DC output device which is as simple as possible in terms of technology, which is why it is also preferable to have a DC output device which comprises a plurality of series resistors; Preferably, 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. preferred

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

Absence of such a remedy can be used. 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. In other cases, different individual current strengths may be preferred; For such cases, it is advantageous if the individual currents are individually adjustable.

Preferably, 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 according to the invention optionally comprises a variable internal resistance for adjusting the output current.

Preferably, a constancy of the current I is ensured by corresponding change in the voltage U.

As mentioned above, a preferred means for keeping the current constant in the DC output device according to the invention is formed automatically. Preferably, this is a regulator, which may be constructed for example of analog components or as an integrated circuit. Such 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. The term "battery" in the context of the present invention, 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 Preferably, 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

V, 2.4 V, 1, 5 V or 1.2 V, this ensures that harmful effects on the body are avoided. The DC output device according to the invention 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.

Optionally, the DC output device according to the invention further comprises a timing means, with which a plurality of periods for delivering the DC current can be predetermined. In the simplest case, this is an electronic switchable interruption of the electrically conductive connection between cathode, DC source and anode. Preferably, 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 , Preferably, the means for timing control is remotely controllable. According to a preferred embodiment, 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.

Preferably, the DC output device according to the invention comprises 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.

Optionally, the DC output device according to the invention 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. Preferably, 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.

Preferably, as described above, 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. Preferably, 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. Under a "needle" is an elongated (preferably cylindrical) Preferably, 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 einzustchende 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. Optionally, 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.

Insofar as the first electrode comprises one or more needles in addition to the planar structures, it is preferable to control the current intensity attributable to the needles separately from the current intensity attributable to the planar structures. For the latter then the above discussed applies. The current of direct current at the needles of the first

The electrode is then preferably 10 to 100 μΑ, preferably 15 to 80 μΑ, 20 to 60 μΑ, 25 to 50 μΑ and 25 to 40 μΑ, and in particular 30 μΑ.

A particularly preferred DC output device according to the invention 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. Optionally, 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 μΑ and in particular 300 μΑ. 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. Further, in the treatment of cluster headache, the first electrode comprises several needles, but not in the treatment of seasonal allergic rhinitis (hay fever).

According to a second aspect, 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).

In other words, 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) or the use of such 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,

Migraine headache or tension-type headache) or allergy (preferably allergic rhinitis, especially seasonal allergic rhinitis, house dust mite allergy, pet allergy or allergic asthma). In yet other words, 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 allergic 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.

According to a fourth aspect, 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:

(a) providing a plurality of planar structures for use as the first electrode,

(b) providing a planar electrode for use as a second electrode,

(c) providing a DC power source or means for connection to a DC power source,

(d) arranging the sheets of the first electrode such that (1) 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

(e) optionally connecting the first and second electrodes to the DC power source.

For preferred embodiments of the method according to the invention for producing a DC output device, the above applies accordingly. Examples

The following terms are used in the description of the following examples:

NSM: treatment with direct current with constant current.

VAS: visual analogue scale with 0 = symptom-free and 10 = unbearable complaints, e.g. Pain or allergic complaints. Needles = 0.25 acupuncture needles, 40 mm long, metal and alloy as described above.

CK: cluster headache

Example 1: Pain

Patient 52 years: strongest chronic cluster headache (CK) on the left for 3 years. At night increased, up to 8 attacks per day, strength VAS 7-10, duration 20-90 minutes per attack. Treatment only with oxygen; Cortisone, triptans and lithium discontinued due to incompatibility. Pain from the back of the head radiating to the temple, forehead, medial eyebrow, nostrils. Patient is suicidal. 6 treatments with NSM stimulation. In each case 6-12 needles inserted in the area of the painful areas. Total stimulation intensity between 120 and 500 μΑ, depending on the number of needles. Due to lack of improvement from the fourth session, use of skin surface electrodes: Adhesive pads approx. 2 cm ² - one päd in the area of the temple / hairline, one päd approximately in the middle above the eyebrow, one päd approximately midway below the eye. Total stimulation strength of the pads 750 μΑ, equivalent to 250 μΑ per ped. Simultaneously 3 needles 0.25 mm by 40 mm inserted over the acupuncture points Bl 10, Gb 20, stimulated with 40 μΑ each. One day after treatment reduction in seizure severity by 50% with unchanged seizure frequency. Repeat the same therapy after one week. Thereafter, the patient is symptom-free for 8 weeks. The subsequent recurrence is treated in the same way with the same success.

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 μΑ each. Puncture at the acupuncture points Gb 21, Bl 10, Taiyang, Gb2. Local anesthesia. In the following Week attacks the same number of times, pain intensity less, no more annihilating. Repeat this therapy at weekly intervals. After the third treatment, the pain increased again to 10 (VAS). In each case directly after the treatment strong CK attack on the way back to the hometown - probably rebound by Nadelbehandlungsreiz. From the fourth to the seventh treatment use of

Adhesive pads, two pads middle forehead (directly adjacent). Stimulation of the pads with a total of 600 μΑ. Additionally 4 needles 0.25 mm back of the head stimulated with 20 μΑ 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 3: Pain

Patient, 49 years: clusters for 20 years, episodes earlier 6 weeks to last 7 months. Since 2012 without interruption CK with constant base pain, for years

Medicines, otherwise attacks. Currently 560 mg verapamil, topiramate 100 mg, so pain-free except for baseline strength 2-3 (VAS). Without medication pain to VAS 10. 20 cigarettes / day. First NSM therapy 9 x 0.25 mm needles, 320 μΑ, 3 back of the head, 6 in the pain area of the face. No improvement. Second session in the same way. Thereupon basic pain increased. Third NSM Treatment: Use of two pads, one ped on the forehead, approximately midway over the eye, one päd on the temple / hairline. No use of needles. Stimulation per päd 250 μΑ. In the following week improvement of the underlying pain. After 2 weeks re-treatment with pads in the same way. Including further improvement of the basic pain on strength 1. Topiramate and verapamil could each be reduced by 50%.

Example 4: Allergy

Patient 35 years: seasonal allergy, pollen and grasses for more than 5 years. Eyes Eye irritation VAS 5, nasal congestion with itching and runny nose current strength 3. One NSM treatment, 3 pads on the acupuncture points Ex 1, Di 20 with a total of 900 μΑ, so 300 μΑ per Päd (current distribution on pads over series resistors 30 kQ). Improvement about 4 hours after the first treatment. After 3 days by gardening again worse. Renewed treatment with the same pad position, now with 400 μΑ per päd, total current 1200 μΑ. Another recovery one day after treatment. Two further treatments each with 3 days distance - afterwards with regard to the allergy symptom free.

Example 5: Allergy patient 58 years: For more than 20 years known hay fever. Every 2 years to

Prevention with success Get 10 acupunctures. This year strong allergic Reaction of the eyes VAS = 7 and nose VAS = 6. Cetirizine tablets and Nasonex drops (mometasone furoate). First NSM treatment with 5 pads and 1500 μΑ, a pawn on Ex 1, and one pa on di 20 and one pa on the lateral orbital rim. One day after the treatment 80% reduction of the complaint. Second treatment in an identical way. Then symptom free for the whole summer.

Example 6: Allergy

Patient 38 years old: from childhood allergic person, premature and late bloomer, nose VAS 7, eyes 8, lung problems with cough and onset of asthmatic respiratory distress at 4 - because of these symptoms the patient can not practice her profession as a fitness trainer without medication. In the past, always cetirizine and cortisone depot injections. First NSM treatment with 4 pads of 400 μΑ each - total current 1600 μΑ. Positioning on the acupuncture points Ex 1, Di 20, Gb1, Ren 22. After two sessions at intervals of three days, the patient is free of complaints for the entire season. No further medication. Patient can easily work as a fitness trainer again.

Example 7: Allergy

Patient: Marked hay fever for 15 to 20 years. Haselblüte, complaints from at the beginning of January to October. Therapy 20 mg Ebastin and evening nasal spray, not satisfactory. Two NSM treatments in late April and early May. Needle 0.3 x 30 mm at the root of the nose, left and right next to the root of the nose, at the lateral orbital rim, next to the nostrils at the level of the nostril - a total of 7 needles set according to the acupuncture points Extra 1, Gb 1, Bl 2 and Di 20. Stimulation each needle with 40 μΑ. Immediate recovery by 90 to 100%, hardly any allergic problems, sleeping without nasal spray possible the very next evening. No medication required for the rest of the hay fever season. The following January, quite mild symptoms, but not permanent. Quality of life improved enormously.

Example 8: Allergy

Patient: For 15 years allergy to dust mites, cat hair and hay fever (grasses and pollen). Daily cetirizine throughout the year. Degradation severity despite drug treatment VAS nose 10, eye 8. 2 NSM treatments in October 2014 at intervals of one week. Needle 0.3 x 30 mm at the root of the nose, left and right next to the root of the nose, at the lateral orbital rim, next to the nostrils at the level of the nostril - a total of 7 needles set according to the acupuncture points Extra 1, Gb 1, Bl 2 and Di 20. Stimulation ever Needle with 40 μΑ. After the first treatment starting, after the second treatment improvement of the symptoms of nose and eyes when exposed to the above allergens by at least 60%. The improvement is persistent. Hay fever in the next season (January to July) does not occur until the observation period at the end of March.

Claims

claims:

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 connection to the DC power source, the first electrode comprising a plurality of planar structures, characterized in that (1) each of the midpoints of the planar The first electrode has a distance of 15 cm or less from at least one other such center, and / or (2) one of the following alternatives holds: (i) all centers of the planar structures 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 planar structures of the first electrode is arranged in such a polygon, the remaining part of the central points is arranged outside the polygon, and when projected into a plane that is so chosen in that the sum of the pitch squares of the polygon corners of the plane is minimal, each out-of-polygon center has at least one polygon intersecting connecting line with another out-of-polygon center, or (iii) a part of the midpoints of the planar formations of the first The electrode is arranged in such a polygon, the remainder of the midpoints are located outside the polygon, at least one connecting line between 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 the polygon intersecting connecting line with another outside center of the polygon.

The DC output device according to claim 1, wherein each of the centers of the sheets of the first electrode is 0.5 cm or more apart from all other such centers.

A DC output device according to any one of the preceding claims, wherein the polygon has an axis of symmetry.

A DC output device according to claim 3, wherein arranged outside the polygon centers of the planar structures of the first electrode to a symmetry axis of the polygon are arranged symmetrically.

A DC output device according to claim 3 or 4, wherein the polygon is a triangle and optionally exactly two of the midpoints of the planar formations of the first electrode lie outside the polygon.

6. DC output device according to one of the preceding claims, wherein at least one connecting line of two centers of the flat structures of the first electrode is parallel to at least one connecting line of two further such centers.

7. DC current output device according to one of the preceding claims, wherein 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 μΑ.

8. DC output device according to one of the preceding claims, wherein the first electrode is formed as a cathode.

9. DC output device according to one of the preceding claims, wherein the area of one, several, or all of the planar structures of the first electrode is in each case in the range of 1 to 10 cm ² .

10. DC output device according to one of the preceding claims, wherein the number of flat structures of the first electrode is 3 or larger and / or the number of planar structures of the first electrode 9 or smaller.

A DC output device according to any one of the preceding claims, adapted for delivery of pulsed DC at a frequency of 1 Hz or less or to a continuous current output.

The DC delivery device of any one of the preceding claims, wherein the first electrode further comprises one or more needles.

13. A DC dispenser according to any one of the preceding claims, further comprising means for keeping the current constant in the delivery of the DC current, wherein the keeping constant is preferably an automated constant.

A DC delivery device according to any one of the preceding claims for use in the treatment of pain or allergy.

The DC delivery device for use according to claim 14, wherein the pain is headache, in particular cluster headache, migraine headache or tension-type headache, and / or the allergy is allergic rhinitis, especially seasonal allergic rhinitis, house dust mite allergy, animal hair allergy or allergic asthma. Use of a DC delivery device according to any one of claims 1 to 13 for the cosmetic treatment of the human or animal body.

A method of manufacturing a DC dispenser, preferably as described in any one of claims 1 to 13, comprising the following steps:

(a) providing a plurality of planar structures for use as the first electrode,

(b) providing a planar electrode for use as a second electrode,

(c) providing a DC power source or means for connection to a DC power source,

(d) arranging the sheets of the first electrode such that (1) 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 such polygon, the remainder of the midpoints are located outside the polygon, 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 midpoint located outside the polygon has at least one of them Polygon intersecting connecting line with another point outside the polygon, or (i ii) a part of the centers of the planar structures of the first electrode is arranged in such a polygon, the remaining part of the centers is arranged outside the polygon, at least one connecting line between two centers is parallel to at least one side line of the polygon, and when projected into said polygon Level, no out-of-polygon center has a connecting line intersecting the polygon with another outside center of the polygon, and