Researchers Submit Patent Application, “Therapeutically Applicable Multichannel Direct Current Delivery Device”, for Approval (USPTO 20170136235)

By a News Reporter-Staff News Editor at Politics & Government Week -- From Washington, D.C., VerticalNews journalists report that a patent application by the inventor Molsberger, Albrecht (Dusseldorf, DE), filed on May 23, 2014, was made available online on May 25, 2017.

No assignee for this patent application has been made.

News editors obtained the following quote from the background information supplied by the inventors: "Many of the medical or cosmetic conditions affecting the human or animal body are local in nature. A medically relevant condition is present in the case of diseases or impairments to the functioning of the body. In these cases a therapeutic treatment is absolutely appropriate. In the case of irritations, which in the context of the present invention include relatively minor impairments or complaints of the human or animal body that do not constitute a disease or disorder and do not require treatment, then at least a cosmetic, non-therapeutic treatment is often useful.

"The present invention relates to both the non-therapeutic cosmetic treatment of cosmetic impairments caused by (mainly local) irritations and to the creation of new treatment options for (mainly local) medically relevant impairments of the human or animal body.

"The concept of treatment also includes prophylaxis. 'Local' means that a certain area affected by the irritation or medically relevant impairment can be found on or in the body. This area is preferably locally circumscribed and more preferably, precisely identifiable. The area (e.g. the irritated area, area of inflammation, painful area) is associated with particular symptoms and triggers the impairment or complaint, or is associated therewith.

"Impairments of the human body or body of an animal which arise from local inflammations and pain conditions are, for example, aseptic inflammations--often due to local stresses (distortions, cases of insertion tendinitis) or also neuropathic pains. In the orthopedic area, local inflammation and pain conditions occur in particular in connection with tissue injuries, in particular of muscles (e.g. muscle trauma), nerves, skin or skeletal support system, vascular injuries or also in connection with nerve inflammation, inflammation of the tendons or bones, or scar formation. There is often a locally defined area in which the complaints can be detected.

"If an impairment meets the criterion of a disease or disturbance to the functioning of the body, it is normally indicated as requiring therapeutic treatment. Examples of a purely cosmetic impairment by contrast are wrinkles, caused for example by increased muscle tone, poor posture and pain-avoiding posture, or purely unsightly skin changes such as areas of redness.

"Methods and means for therapeutic or cosmetic treatment of medical or cosmetic impairments and complaints are known. Even if in some cases e.g. physiotherapy can provide relief, as a rule however, specific pharmaceutical agents are used, primarily cortisone, non-steroidal anti-inflammatory drugs, analgesics and related substances. In addition to the desired (local) effect, these usually have unwanted local side effects (e.g. in the case of local applications of cortisone, aseptic inflammations) and/or systemic side effects, and these can have adverse effects on the metabolism and hormone balance. In many cases, the conventional therapeutic methods cannot treat a chronic form of a disease. It is therefore advisable to take into consideration alternatives to the use of (exogenous) active substances.

"A number of treatment options also exist which are known to make increased use of the intrinsic healing capacities of the human or animal body. A widely used technique is acupuncture and its variants, a technique based on traditional Chinese medicine (TCM).

"Acupuncture is generally recognized as being effective and of low risk in the treatment of certain complaints, such as chronic pain (e.g. headache, migraine). Thus since 1st January 2007 all the German statutory health insurance funds have covered acupuncture treatments, in particular those based on the results of large-scale and randomized trials (GERAC, German acupuncture trials), in the treatment of chronic lower back pain and chronic knee pain in osteoarthritis of the knee. Private health insurance companies pay for acupuncture services for the treatment of pain, and usually for other indications as well, on a case-by-case basis. The 'Cochrane reviews' of 2009 classify acupuncture as 'a valuable non-pharmacological treatment option for patients with frequent episodic tension headache' and conclude that the 'acupuncture treatment of migraine is at least as effective, possibly even more effective, than a drug-based prophylactic therapy, and with fewer adverse side-effects'.

"It was shown in the GERAC studies that no significant difference existed between acupuncture treatment at points that follow the guidelines of TCM and acupuncture treatment at other points (so-called 'fake acupuncture'). Positive therapeutic or cosmetic effects have been demonstrated for both forms of acupuncture when applied to local inflammation and pain conditions. Nowadays other forms of acupuncture are also commonly used that are not derived from the traditional theoretical framework of TCM.

"Endogenous physiological electrical fields are known in biology. These fields are in the range of 70 mV/mm (nerve growth in chickens), 140 mV/mm (wound healing in rats), 600 mV/mm (eye lens of vertebrates) up to 1500 mV/mm (development of the neuronal tube in the axolotl). Depending on the internal resistance of the relevant biological tissue, these give rise to currents of 10-200 .mu.A. Endogenous electrical fields build up for a period lasting from hours to weeks, for example in the region of the wound, in the region of the active cell growth and in cell migration, and appear to be essential for the regulation of cell behavior.

"The merits of the use of exogenous electric fields in the fields of medicine and cosmetics are known. The types of fields regularly used are strong and/or time-varying fields, wherein the temporal variability is effected by alternating voltage or short direct-current voltage pulses. These strong electric fields used for therapeutic purposes up to now are generated, for example, by high voltages and in many cases by strong currents. In this context, AC and AC-pulsed current devices are used, in order to counteract electrolytic effects at the electrodes used and in particular on the body tissue.

"One known method is transcutaneous electrical nerve stimulation (TENS). In this technique low-frequency (1-100 Hz) biphasic alternating current pulses are used for pain relief, primarily for short-term 'electrical analgesia'. The voltage level is up to 70 V with a pulse width of approx. 250 .mu.s at a current intensity of up to 90 mA. The effect is primarily based on an increase in the central release of endorphins. It is unclear whether local or longer-term effects are also obtained in the affected tissues.

"Also known is the technique of electro-acupuncture. Its action mechanism targets the release of central pain-relieving substances, in particular of encephalins, endorphins and dynorphins.

"As described in document US 2004/0111128 A1, electro-acupuncture also uses alternating currents. In electro-acupuncture a low-frequency stimulation current is applied (Springer Lexicon of Medicine), where the frequency of the electrical signal is either fixed or variable (2-10,000 Hz). As in the case of TENS, relatively high currents are used that can be between 2 and 15 mA. These can be applied in pulsed mode at this intensity with a pulse width of approximately 0.3-0.6 ms. In order to avoid electrolytic effects at the junction between the electrode and biological tissue when using these high currents, the polarity is alternated (alternating current/AC). Accordingly, the electrical parameters used in electro-acupuncture will in every case include frequency and intensity (see a summary of parameters for electro-acupuncture accessible under the URL http://www.icmart.org/index.php?id=198.0.0.1.0.0 originating from a conference of the International Council on Medical Acupuncture and Related Techniques).

"In summary, the known devices for TENS or electro-acupuncture involve technically complex circuitry, they operate with high currents, short pulses and AC power at specific frequencies. In spite of this, the stimulation dose is often not controllable. These means and methods of the prior art are aimed at pain relief, which is based on a central analgesic effect. They are not focused on any local action (such as an anti-inflammatory or regenerative effect).

"In tumor therapy a direct-current Galvano-therapy with high current intensities of 60-80 mA at a voltage of 6-35 V is known. This therapy is intended to bring about a destruction of the tumor tissue, for example by necrosis. A destruction of tissue is therefore in this case not an undesirable effect to be avoided, but on the contrary, is explicitly strived for. The method makes use of the increased conductivity of tumor tissue in comparison to healthy tissue, so as to selectively concentrate the current flow in the tumor tissue and cause the decay of the tumor due to electrolytic and necrotizing effects.

"Direct current is also used for the transcutaneous transport of ionisable drugs (iontophoresis). The voltages used are about 36-60 V at currents of about 10-30 mA. In order to avoid local tissue damage and to be able to transport a high dose of active ingredients electrophoretically, large skin electrodes have to be placed on the skin.

"Another known technique is the application of large-area wet cellulose electrodes to the scalp for stimulating the central nervous system (transcranial direct current stimulation tDCS), for example in the case of tinnitus. In this technique, a current of up to 1 mA and a voltage of 8-25 V are used with a constant pulsating current.

"It is well known that the corresponding electrical fields generated by weak direct current promote growth of blood vessels, due inter alia to the release of VEGF and its influence on endothelial cells. They cause a movement and rearrangement of cell membrane receptors, increase the division rate of particular cells and accelerate cell migration of epithelial cells. This cell migration takes place away from the anode (positive pole) and towards the cathode (to the negative pole). In animal experiments, there are indications that the rate of peripheral nerve regeneration after spinal cord trauma can be accelerated, the axons of the nerve cells growing towards the cathode, which must be positioned cranially over about three weeks. Clinical studies in humans indicate an acceleration of wound healing due to electrical fields.

"Document DE 10 2012 010 262 discloses a direct current output device which comprises a means for maintaining the current intensity constant during the delivery of the DC current. There is, however, no information in the document on which specific currents must be kept constant, and in particular no information on how individual currents are held constant in the individual needles.

"The foregoing statements, together with the description of exemplary embodiments contained in the present text, do not entail the exclusion of particular embodiments or features."

As a supplement to the background information on this patent application, VerticalNews correspondents also obtained the inventor's summary information for this patent application: "The technical problem addressed by the present invention is to provide new means and methods with which local impairments of the human body or the body of an animal, in particular those caused by inflammation and/or pain, can be alleviated or eliminated.

"Preferably, the means and methods according to the invention allow a more effective, safer and more reproducible application and/or with fewer side effects, and/or have a faster acting and/or longer-term effect than the means and methods from the prior art. The means and methods according to the invention preferably allow the treatment of local impairments that either are not appropriately treated with the means from the prior art or cannot be treated at all.

"The technical problem is solved in accordance with a first aspect of the present invention by a direct current output device, comprising a direct current source or a device for connecting to a direct current source, and a first electrode and a second electrode for connecting to the direct current source, wherein the first electrode is designed as a multiplicity of needles and the second electrode is designed as a flat electrode (preferably an adhesive electrode), as a needle or a multiplicity of electrically conductive needles directly connected to one another, characterized in that the direct current output device comprises one or more means for holding each current intensity constant during the individual output of direct current through needles of the first electrode (in particular in the event of a change in resistance connected to a needle of the first electrode), wherein the constant current preferably applies to all needles of the first electrode.

"A preferred form of the direct current output device according to the invention is one in which the needles of the first electrode are not directly electrically conductively connected to each other. Also preferred is a direct current output device according to the invention in which the second electrode is designed as a flat electrode (adhesive electrode).

"The term 'adhesive electrode' is in this case understood to mean a flat electrode that can be applied to the (possibly depilated) skin surface and can be fixed there (possibly by using an additional material mediating or improving the conductivity, such as an electrode gel or paste), preferably by adhesion.

"A 'direct' electrically conductive connection is understood to mean an electrically conductive connection by means of a simple cable or other type of electrically conductive connection without intermediately connected electrical components. This would exclude, for example, an electrically conductive connection which is based solely on the fact that components of a circuit, such as resistors, are arranged between the two connected elements.

"For the purposes of the present application a flat, two-dimensional electrode is sometimes also referred to as a 'pad'.

"According to a second aspect, the present invention also relates to the direct current output device according to the invention for use in the treatment of inflammation and/or pain conditions, especially of the muscles, nerves, tendons or bones.

"In other words, the subject matter of this aspect of the present invention is also the use of the direct current output device according to the invention for treating cases of inflammation and/or pain, in particular of the muscles, nerves, tendons or bones, or the use of the direct current output device for producing a therapeutic device for treating cases of inflammation and/or pain, in particular of the muscles, nerves, tendons or bones. This aspect of the present invention also relates to a method for treating cases of inflammation and/or pain, in particular of the muscles, nerves, tendons or bones of a patient who requires such treatment, which comprises allowing the direct current output device according to the invention to be applied to the body of the patient.

"The technical problem addressed by the present invention is also solved in accordance with a third aspect by means of a kit for producing a direct current output device according to the invention (preferably as described above), which comprises: a multiplicity of needles for use as a first electrode, a flat electrode (e.g. an adhesive electrode), a needle or a multiplicity of needles for use as a second electrode, one or more means for holding each current intensity constant during the individual output of direct current using needles of the first electrode connected to a direct current source (or: using the needles connected to a direct current source), (in particular in the event of a change in resistance connected to a needle of the first electrode), and optionally, means for the direct electrically conductive connection of a multiplicity of needles.

"The word 'comprising' also includes the meaning of 'consisting of' and in preferred embodiments has the latter interpretation, except where the context demands otherwise. The same applies to the variants of the term, such as 'comprise' and 'consist of'.

"Direct current is understood as meaning an electric current whose direction does not change and whose time-averaged current intensity does not substantially change under constant external conditions. The direct current is preferably a 'pure' direct current, the intensity of which does not change substantially or does not change at all, under constant external conditions. However, certain temporal fluctuations are possible, in particular a 'pulsed' direct current, in which the current intensity periodically oscillates about a particular mean value, but without the current direction changing. The direct current is therefore preferably a direct current which oscillates about a previously set (preferably constant) value. The oscillation preferably occurs at a frequency between 0.001 and 10 Hz, in particular between 0.01 and 1 Hz, for example, 0.1 Hz. The oscillation waveform is preferably rectangular, saw-toothed and in particular, sinusoidal. The deviation of the direct current is preferably 50% of the previously set value (i.e. the values move between 150% and 50% of the previously set value), and in particular 40%, 30%, 20%, 15%, 10%, 7.5%, 5%, 2.5% or 1%.

"The present invention is based on the discovery that weak direct current can alleviate the above-mentioned medical or cosmetic impairments and complaints when it acts on the body via an electrode in a local DC voltage electric field. The effects occur even if the direct current is very weak. A particularly well reproducible effect can be achieved if the direct current is constant.

"One of the findings underlying the present invention then, is the fact that the effect is particularly beneficial (e.g. with regard to the reproducibility of the effect, the strength of the effect, the rapidity of the onset of action, duration of continuation of the effect and/or the ability to treat particular impairments or complaints), when not only is the current intensity of the direct current maintained at a constant level overall, but when the respective current intensity is held constant during the individual supply of direct current through the needles of the first electrode. In other words, the relevant needles of the first electrode output a constant current intensity as a whole (preferably each one of the needles), and not just of the first electrode. In this way, by providing one or more means for respectively maintaining a constant current intensity of the direct current output by (the) individual needles of the first electrode, a multi-channel device is produced. Each individual channel, i.e. the current intensity of the individual needles of the first electrode, can thus be held constant. The current intensity output by an individual needle of the first electrode is designated hereafter as the 'individual current intensity'. The direct current output device according to the invention, in other words, is characterized by the fact that it comprises one or more means for keeping the individual current intensities constant.

"Depending on the application, needle-shaped or flat electrodes achieve particularly good effects (e.g. two needle-shaped electrodes or one needle-shaped electrode in combination with a flat electrode, wherein a needle-shaped electrode comprises a multiplicity of needles and the flat electrode, if present, optionally comprises a multiplicity of flat structures). The applied electric field according to the invention is in the same order of magnitude as endogenous and physiological electrical fields.

"The current intensity determines the intensity of the electric field in the tissue. A constant current intensity (in contrast to, for example, the setting of a constant voltage) is advantageous to the extent that any fluctuations in the resistance cannot cause fluctuations of the current intensity and in particular, no current peaks. Also, inter-individual differences in the resistance (in contrast to the setting of a constant voltage) do not give rise to different current intensities.

"The direct current output device according to the invention (as described above) comprises one or more means for respectively keeping the current intensity constant during the individual output of the direct current through the needles of the first electrode (in particular in the event of a change in the resistance which is connected to (each) one or more of the needles of the first electrode). The direct current output device preferably comprises such a means for each of the needles of the first electrode. This/these means is/are designed to keep the current intensity constant during the output of the direct current, in particular when the resistance connected to (each) one or more of the needles of the first electrode changes. Without such a means the situation often exists whereby the electrical resistance of the body tissue (for example, the skin) varies during the treatment and so the current intensity also varies. It is a finding of the present invention that, by using the one or more means described above for keeping the current constant, impairments or complaints which otherwise are not or not adequately treatable, consequently become treatable. It has also been found that without such means for maintaining the current constant, due to individual differences in the resistance between the skin and tissue, which is usually in the range of 1-40 k.OMEGA. (typically 1-10 k.OMEGA.), different current intensities are observable in different individuals, which causes the treatment outcome to vary to a certain extent. When using the one or more means for maintaining a constant current, a constant treatment outcome is achieved regardless of the individually differing resistance between the skin and the tissue.

"The direct current output device according to the invention enables an improvement in or elimination of cosmetically or medically determined bodily impairments and complaints. These are preferably cases of inflammation and/or pain, and in particular locally indicated. According to the invention, the use of exogenous pharmaceutical substances or medications can be reduced or completely avoided. The unwanted side effects of such substances thus occur to a lesser degree or not at all. When using the direct current output device the impairments and complaints are alleviated or eliminated or even prevented, permanently or at least in the long term. If the application is repeated, the effect can often be increased to include permanent freedom from the complaints.

"The use of the invention-based direct current output device involves low risk, is effective and almost or completely free of side effects. The effect occurs rapidly and predictably. The output current dosage can be precisely controlled. A further advantage is that, according to the invention, regeneration of tissue damaged by chronic inflammation or degenerative processes is also made possible. The efficacy against inflammation and pain according to the invention is considerably better than that found in electro-acupuncture according to the prior art.

"The direct current output device according to the invention has, in its application to the human or animal body, in particular an anti-inflammatory and analgesic effect, which is of advantage for example in the treatment of (particularly local) inflammations and pain, in particular of the muscles, nerves, tendons or bones. Examples of treatable conditions are aseptic inflammations, nerve pain (e.g. neuropathic pain), headache and orthopedic indications, such as pain in the thoracic spinal column or shoulders, back pain, or tendonitis (e.g. tennis elbow). The cases of inflammation/pain can be related, for example, to tissue injuries (e.g. muscles, nerves, skin or skeletal support system, vascular system), nerve inflammation, inflammation of the tendons or bones and scar formation.

"The direct current output device according to the invention allows a treatment concept which is based on acupuncture. It can be applied separately or can be integrated into the normal context of acupuncture treatment. Such an approach may extend acupuncture treatment and thus improve the associated therapeutic or cosmetic treatment of complaints or impairments.

"According to the invention, the direct current output device according to the invention can be used to treat the bodies of human or animal patients. The term 'patient' is not to be understood restrictively in terms of a therapeutic treatment, but also covers a cosmetic treatment. Preferred patients are mammals such as horses, dogs, cats, or camels, and in particular human beings."

For additional information on this patent application, see: Molsberger, Albrecht. Therapeutically Applicable Multichannel Direct Current Delivery Device. Filed May 23, 2014 and posted May 25, 2017. Patent URL: http://appft.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PG01&p=1&u=%2Fnetahtml%2FPTO%2Fsrchnum.html&r=1&f=G&l=50&s1=%2220170136235%22.PGNR.&OS=DN/20170136235&RS=DN/20170136235

Keywords for this news article include: Patents, Therapy, Cortisone, Health Insurance, Adrenal Cortex Hormones, 17-Hydroxycorticosteroids.

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