DE202014104392U1 - Composable, flexible iontophoresis heater - Google Patents

Abstract

A composite, flexible iontophoresis heater, comprising: a portable power supply unit that supplies the device with direct current, the power supply unit being externally connected to an inductance coil (choke coil) which converts an alternating voltage into a direct voltage and filters it to provide a current having alternating polarities ; a microprocessor that is used to control frequencies and voltages with alternating polarities and for calculation; a sacrificial electrode (24), which serves as a power distribution element, is connected to the power supply unit and the microprocessor and whose oxidation or reduction requires a voltage which is lower than the voltage required for significant water electrolysis; an ion layer (25) which is arranged between the sacrificial electrode 24 serving as a current distribution element and the semipermeable membrane 26, it being possible for the ion layer (25) to contain counterions which interact with the other ions generated by an electrochemical action by the sacrificial electrode 24 let connect and therefore can generate the insoluble or the electrically neutral counterions of an end product; a semipermeable membrane (26) which is made of a material which can select the polarities of the ions itself, the semipermeable membrane (26) allowing the ions coming from the organism or the ions having an electrical opposite polarity compared to that of the drugs, enter the ion layer (25) in a single direction; a drug zone (27) which is separated from the ionic layer (25) by the semipermeable membrane 26 and in which corresponding drugs are contained; an underlayer (29) which is arranged close to a location adjacent to the medicinal substance zone (27) and allows the medicinal substances or substances to be used to pass through; and a flexible heat generator (28) which is connected to the power supply unit via a connection cable and with which the skin area to be treated can be heated.

Description

The invention relates to an electronic medical device, in particular an electronic medical device, in which a serving for heating electrode is operated as required with a variety of voltages and currents, so that desired heating effects in a heat therapy and iontophoresis can be achieved.

In a conventional heat therapy, previously heated carriers are most commonly used. For example, warm water is introduced into a rubber bottle made of rubber, which is then applied as a carrier to a human body part of a patient. A disadvantage, however, in the solution that it often leads to combustion when the hot water bottle tips over when filling the warm water or when the warm water seeps through. Alternatively, the carrier may be made of a gel that is non-toxic in contact with the human body, such as a gel. Example, be prepared from propylene glycol, which is first heated by means of a microwave oven and then used in a heat therapy, with burns due to leakage or bursting also often occur. For some products, the gel used contains toxic substances such. As the ethylene glycol.

In order to overcome the above-mentioned disadvantages of conventional heat therapy, electronic heaters have been developed and used in the field of heat therapy. For example, such heaters from the patents US 4,798,933 and US 5,041,717 known, wherein rigid, electronic heating elements of the heaters are mounted by inserting or other fastening methods in a fabric made of textile fabric unit, which is cut as needed to a certain extent. In addition, the said electronic heating elements are connected to corresponding batteries, so that an everywhere portable product is formed. However, the use of the rigid electronic heating elements of the above-mentioned type is limited by the following conditions: 1) The production of such a heating element is relatively complicated, resulting in high manufacturing costs; 2) Due to its thickness and its rigidity, there is a lack of air permeability, whereby the product is not individually addressed to a user such. B. can be adapted to a curved skin surface of the user, etc. Particularly noteworthy is that the rigid, electronic heating elements are severely limited by a circuit design, so annoying the user the blocky rigid elements, which often leads to a feeling of discomfort.

The invention has for its object to provide a flexible electrical heating element, which is assembled in combination with an iontophoresis assembly to a portable medical electrical device to avoid the above-mentioned shortcomings.

This object is achieved by a composite, flexible iontophoresis heater having the features specified in claim 1. Further advantageous developments of the invention will become apparent from the dependent claims.

• 1. Gemäß der Erfindung wird eine flexible Elektronikschaltung verwendet, die leicht und dünn ist, sodass sich das Produkt von den herkömmlichen Produkten unterscheidet. Aufgrund biegsamer Eigenschaft kann das Produkt in vielfältigen Situationen verwendet werden. In der vorliegenden Erfindung wir ein selbstregelndes Heizelement als elektronisches Heizelement verwendet, wodurch der komplizierte Aufwand einer Temperaturregelung vermieden wird. Um die Aufgabe zu erfüllen, werden Materialien mit positiven Temperaturkoeffizienten (wie z. B.: Silber, Aluminium, Gold) in einem bestimmten Bereich des erfindungsgemäßen Heizelementes verwendet, während die anderen Bereiche des erfindungsgemäßen Heizelementes aus einem weichen Material wie z. B. aus Kieselgelmaterial hergestellt werden, sodass ein dünnes und flaches Heizelement, das sich biegen lässt, ausgebildet ist, um ein normales Vollmetallheizgerät zu ersetzen. Dank der besseren Biegsamkeit kann das erfindungsgemäße Heizelement gut an eine zu erwärmende Hautfläche angepasst werden, wobei das Heizelement dicht an eine gekrümmte Hautfläche anliegen kann, selbst wenn die Hautfläche eine unregelmäßige Form aufweist.
• 2. Durch die vorliegende Erfindung wird der Verwendungsbereich eines zur Wärmetherapie dienenden, elektronischen Medizingerätes erweitert. Besonders zu erwähnen ist, dass ein Iontophorese-System in dem zur Wärmetherapie dienenden, elektronischen Medizingerät integriert werden kann. Unter dem genannten Iontophorese-System wird eine tragbare Wegwerf-Iontophorese-Vorrichtung verstanden, die lediglich zur einmaligen Darreichung von Arzneistoffen durch die Haut dient, wobei das Iontophorese-Gerät integrierte Batterie und eine feste Kleinstromschaltung aufweist. Bei der Verwendung liefert die tragbare Iontophorese-Vorrichtung einen schwachen elektrischen Gleichstrom (Einheit: Milliampere), der in jeder Minute konstant ist, als eine Darreichungsenergie, sodass wasserlösliche Arzneistoffe mit einer positiven bzw. negativen, elektrischen Ladung bei der Iontophorese dargereicht werden. Weil die Iontophorese-Vorrichtung mit einem schwachen Gleichstrom arbeitet, kann der Benutzer über einen relativ langen Zeitraum mit einer konstanten Darreichungsdosis behandelt werden. Um einen Patienten mit einem nicht wasserlöslichen Arzneistoff zu behandeln bzw. um wasserlösliche Moleküle bei der Behandlung für eine weitere Analyse ausleiten zu können, werden Opferkathoden bzw. -anoden, die oxydieren bzw. sich reduzieren lassen, in der vorliegenden Erfindung als ionenleitende Elektroden verwendet. Weil die als Stromverteilungselement dienenden Opferelektroden aus einem ausgewählten Material hergestellt werden, dessen Oxidation bzw. Reduktion eine Spannung benötigt, die niedriger als die für eine deutliche Wasserelektrolyse benötigte Spannung ist, wird eine chemische Zersetzung der als Stromverteilungselement verwendeten Opferelektroden durch Wasserelektrolyse wesentlich vermieden.
• 3. Um einen sicheren Kontakt mit einem Organismus zu garantieren, werden zwei oder mehr als zwei erfindungsgemäße Heizelemente nachgeschaltet, sodass die Ionen kontinuierlich weitergeleitet werden, wobei die als Stromverteilungselement dienenden Opferelektroden aus einem gleichen Material (wie z. B.: aus Silber/ Silberchlorid) hergestellt werden können. Bei dem erfindungsgemäßen Heizgerät stellen eine Ionenschicht und eine semipermeable Membran symmetrische Gegenionen für die Opferelektroden bereit, wobei ein Ionendurchlass unter Einwirkung eines Stromkreises lediglich in einer Richtung von dem Organismus in eine Arzneistoffzone erlaubt ist. Noch konkreter gesagt, werden die Opferelektroden bei dem erfindungsgemäßen Heizgerät als Stromverteilungselement verwendet, wobei elektrochemisch berücksichtigt werden muss, dass die Gegenionen allein nicht verhindern können, dass die während einer elektrochemischen Reaktion durch das Stromverteilungselement (wie z. B.: durch die Silberelektroden, auch Ag genannt) erzeugten Ionen (Silberionen, auch Ag⁺ genannt) in die Arzneistoffzone eintreten, sodass eine Ionenverschmutzung vorkommt. Deswegen soll die mit den Opferelektroden verbundene Ionenschicht genügende Gegenionen (wie Chlorionen, Cl^–) bereitstellen, um häufig bei der Verwendung der Opferelektroden konfrontierte Probleme zu lösen. Die semipermeable Membran wird aus einem Material, das die Polarität der Ionen selbst selektieren kann, hergestellt und zwischen der Ionenschicht und der Arzneistoffzone angeordnet, wodurch realisiert wird, dass lediglich die von dem Organismus kommenden Ionen (beispielsweise Natriumionen, Na+) in die Ionenschicht eintreten können, sodass sich die Ionen nicht in der Arzneistoffzone häufen und dadurch Widerstände erhöhen oder mit den Arzneistoffen eine unerwartete Reaktion verursachen, was eine Darreichung von allen ionisierten, wasserlöslichen Arzneistoffen ermöglicht.

Compared to conventional electronic heaters, the iontophoresis heater according to the invention has the following advantages in heat therapy:

• 1. According to the invention, a flexible electronic circuit is used which is light and thin so that the product differs from the conventional products. Due to its flexible nature, the product can be used in a variety of situations. In the present invention, we use a self-regulating heating element as an electronic heating element, whereby the complicated cost of a temperature control is avoided. In order to achieve the object, materials having positive temperature coefficients (such as, for example, silver, aluminum, gold) are used in a certain area of the heating element according to the invention, while the other areas of the heating element according to the invention from a soft material such. For example, be made of silica gel material, so that a thin and flat heating element that can be bent, is designed to replace a normal full metal heater. Thanks to the better flexibility, the heating element according to the invention can be well adapted to a skin surface to be heated, wherein the heating element can be tight against a curved skin surface, even if the skin surface has an irregular shape.
• 2. The present invention expands the field of use of an electronic medical device used for heat therapy. Particularly noteworthy is that an iontophoresis system can be integrated into the thermal therapy electronic medical device. The term iontophoresis system is understood to mean a disposable portable iontophoresis device which merely serves for the single administration of medicaments through the skin, the iontophoresis device having an integrated battery and a fixed small current circuit. In use, the portable iontophoresis device provides a weak DC electrical current (unit: milliamperes), which is constant every minute, as a delivery energy, so that water-soluble drugs with a positive and negative, respectively, electric charge during iontophoresis be presented. Because the iontophoresis device operates on a low DC current, the user can be treated with a constant dose of dosage over a relatively long period of time. In order to treat a patient with a non-water soluble drug or to deliver water soluble molecules in the treatment for further analysis, sacrificial cathodes or anodes that can be oxidized are used as ion conducting electrodes in the present invention. Because the sacrificial electrodes serving as the current distribution element are made of a selected material whose oxidation or reduction requires a voltage lower than the voltage required for significant water electrolysis, chemical decomposition of the sacrificial electrodes used as the current distribution element by water electrolysis is substantially avoided.
• 3. In order to guarantee a secure contact with an organism, two or more than two heating elements according to the invention are connected downstream, so that the ions are passed on continuously, whereby the sacrificial electrodes serving as current distribution element are made of a same material (such as, for example: silver / silver chloride ) can be produced. In the heater according to the invention, an ion layer and a semipermeable membrane provide symmetrical counterions for the sacrificial electrodes, wherein an ion passage is allowed under the action of a circuit only in one direction from the organism into a drug zone. More specifically, the sacrificial electrodes are used in the heater according to the invention as a current distribution element, it must be considered electrochemically that the counterions alone can not prevent that during an electrochemical reaction by the power distribution element (such.: By the silver electrodes, also Ag) called ions (silver ions, also called Ag ⁺ ) enter the drug zone, so that ion contamination occurs. Therefore, the ion layer connected to the sacrificial electrodes should provide enough counter ions (such as chlorine ions, Cl ^- ) to solve problems often encountered in using the sacrificial electrodes. The semipermeable membrane is made of a material that can select the polarity of the ions themselves, and placed between the ionic layer and the drug zone, realizing that only the ions coming from the organism (e.g. sodium ions, Na +) can enter the ionic layer so that the ions do not accumulate in the drug zone, thereby increasing resistances or causing an unexpected reaction with the drugs, allowing for administration of all ionized, water-soluble drugs.

In the following the invention and its embodiments will be explained in more detail with reference to the drawing. In the drawing shows:

1 a circuit according to the invention; and

2 an exploded perspective view of the composable and flexible heating element of an iontophoresis device according to the invention.

• – eine tragbare Stromversorgungseinheit, die das Gerät mit einem Gleichstrom versorgt, wobei die Stromversorgungseinheit extern mit einer Induktivitätsspule (Drosselspule), die eine Wechselspannung in Gleichspannung umwandelt und filtert, verbunden wird, um einen Gleichstrom mit abwechselnden Polaritäten bereitzustellen;
• – einen Mikroprozessor, der zur Steuerung von Frequenzen und Spannungen mit abwechselnden Polaritäten und zur Errechnung dient;
• – eine als Stromverteilungselement dienende Opferelektrode, deren Oxidation bzw. Reduktion eine Spannung benötigt, die niedriger als die für eine deutliche Wasserelektrolyse benötigte Spannung ist;
• – eine Ionenschicht, in der Gegenionen enthalten sein können, welche sich mit den unter einer elektrochemischen Einwirkung durch die Opferelektrode erzeugten, anderen Ionen verbinden lassen und daher unlösliche Substanzen bzw. die elektrisch neutralen Gegenionen eines Endproduktes erzeugen können;
• – eine semipermeable Membran, die aus einem Material, das die Polaritäten der Ionen selbst selektieren kann, hergestellt und zwischen der Ionenschicht und der Arzneistoffzone angeordnet wird, wobei erlaubt ist, dass die von dem Organismus kommenden Ionen bzw. die Ionen, die eine elektrische Gegenpolarität gegenüber derjenigen der verwendeten Arzneistoffe aufweisen, in einer einzigen Richtung in die Ionenschicht eintreten;
• – eine Arzneistoffzone, in der ionisierte Arzneistoffe, Naturstoffe bzw. Vitamine usw. eingefüllt werden;
• – eine Unterschicht, die dicht an einer der Arzneistoffzone benachbarten Stelle angebracht ist und einen Durchlass der zu verwendenden Arzneistoffe bzw. Substanzen erlaubt; und
• – ein biegsames (flexibles) Heizelement, das aufgrund seines Wärmerzeugungsmechanismus eine geeignete Temperatur erzeugt, sodass eine konstante Elektrowärme, Lichtwärme oder Chemiewärme zur Verfügung gestellt wird.

In 2 an improved portable electrode permitting administration of drugs through the skin is shown in an exploded view, wherein the composite flexible iontophoretic heater comprises the following main components:

• A portable power supply unit which supplies the device with a direct current, wherein the power supply unit is connected externally with an inductance coil (choke coil), which converts an AC voltage into DC voltage and filters, to provide a DC current with alternating polarities;
• - A microprocessor, which serves to control frequencies and voltages with alternating polarities and for the calculation;
• - A serving as a current distribution element sacrificial electrode whose oxidation or reduction requires a voltage which is lower than the voltage required for a significant water electrolysis;
• An ion layer in which counterions can be contained, which can be combined with the other ions produced by the sacrificial electrode under electrochemical action, and can therefore produce insoluble substances or the electrically neutral counterions of a final product;
• A semipermeable membrane made of a material which can select the polarities of the ions themselves, and placed between the ionic layer and the drug zone, allowing the ions or ions coming from the organism to have an electrical opposite polarity opposite to those of the drugs used, enter the ion layer in a single direction;
• A drug zone in which ionized drugs, natural products or vitamins, etc. are filled;
• A sub-layer which is closely attached to a site adjacent to the drug zone and allows a passage of the drugs or substances to be used; and
• - A flexible (flexible) heating element, which generates a suitable temperature due to its heat generating mechanism, so that a constant electric heat, light heat or chemical heat is provided.

• a) Auswählen von Arzneistoffen bzw. anderen Substanzen, welche bei einer Iontophorese ein- und ausgeleitet werden;
• b) Sensorelemente für die zu verwendenden Arzneistoffe bzw. Substanzen werden in der Arzneistoffzone eingebracht, wobei die dicht an die Arzneistoffzone angrenzenden Unterschicht für einen Durchlass der Arzneistoffe bzw. Substanzen sorgt;
• c) Auswählen des geeigneten Stromverteilungselementes und der Ionenschicht;
• d) Auswählen einer semipermeablen Membran, wobei die Membran eine selektive Permeabilität aufweist, sodass die Substanzen, die eine elektrische Gegenpolarität gegenüber derjenigen der Arzneistoffe bzw. Substanzen aufweisen, durch die semipermeable Membran passieren können;
• e) Die ausgewählte Ionenschicht und die semipermeable Membran werden mit dem Stromverteilungselement verbunden und auf der Arzneistoffzone befestigt, wobei die Ionenschicht und die semipermeable Membran zwischen dem Stromverteilungselement und der Arzneistoffzone angeordnet werden;
• f) Die genannten Bestandteile werden mit der Stromversorgungseinheit und dem Mikroprozessor verbunden, sodass die Arzneistoffzone und das flexible Heizelement nach dem Einschalten funktionieren.

The present invention further relates to a method of assembling the improved ion-conducting electrode, which is assembled in the following order:

• a) selecting drugs or other substances which are introduced and discharged during iontophoresis;
• b) sensor elements for the drugs to be used or substances are introduced in the drug zone, wherein the close to the drug zone adjacent lower layer provides for a passage of the drugs or substances;
• c) selecting the appropriate power distribution element and the ion layer;
• d) selecting a semipermeable membrane, the membrane having a selective permeability so that the substances having an electrical opposite polarity to those of the drugs or substances can pass through the semipermeable membrane;
• e) the selected ion layer and the semipermeable membrane are connected to the current distribution element and attached to the drug zone, the ion layer and the semipermeable membrane being located between the current distribution element and the drug zone;
• f) The said components are connected to the power supply unit and the microprocessor so that the drug zone and the flexible heating element function after being switched on.

The composite flexible heating element according to the present invention can be used on the one hand to deliver molecules of the water-soluble drugs and on the other hand to administer the water-soluble substances, the administration being as follows: When a positively charged drug is presented (for example, when hydromorphone is used in a therapy for Pain relief is given), which is used as a power distribution element 24 serving sacrificial electrode of a slightly oxidized material such. As silver, wherein the ion layer 25 which may contain counterions which can react with silver ions (such as chlorine ions, Cl, acetate ions, CH3C00-) to form the insoluble or electrically neutral counterions of a final product. Once the sacrificial electrode 24 (Silver) is turned on with electricity, silver ions are released. It should be mentioned, however, that the chlorine ions in the ionic layer 25 react with the silver ions and produce insoluble silver chloride which is deposited, whereby the silver ions enter the drug zone 27 is prevented. When a negatively charged drug is presented (for example, when acetate ions are added to treat myositis), it becomes the current distribution element 24 serving sacrificial electrode of an easily reducible material such. As silver / silver chloride o. Ä. Used, wherein the ionic layer 25 which may contain counterions which, together with chlorine ions (such as lead ions, Pb2 +), may react to produce the insoluble or electrically neutral counterions of an end product. Once the sacrificial electrode 24 (Silver / silver chloride) is turned on with electricity, chlorine ions are released. It should be noted that in the ionic layer 25 lead ions react with the chlorine ions and produce insoluble deposits of lead (II) chloride, thereby causing the silver ions to enter the drug zone 27 is prevented.

LIST OF REFERENCE NUMBERS

11

 Anode circuit board

12

 Cathode circuit board

13

 serving as a power battery

14

 resistance

15

 switch

16

 resistance

17

 LED

18

 resistance

19

 diode

21

 Upper lidding material

22

 adhesive

23

 Connection pins for microprocessor / power supply unit

24

 sacrificial electrode

25

 ion layer

26

 semipermeable membrane

27

 Drug zone

28

 flexible heat generator and its connection cable

29

 underclass

QUOTES INCLUDE IN THE DESCRIPTION

This list of the documents listed by the applicant has been generated automatically and is included solely for the better information of the reader. The list is not part of the German patent or utility model application. The DPMA assumes no liability for any errors or omissions.

Cited patent literature

• US 4798933 [0003]
• US 5041717 [0003]

Claims (5)

A composite, flexible iontophoretic heater, comprising: a portable power supply unit that supplies the device with DC power, the power supply unit being externally connected to an inductor coil that converts and filters an AC voltage to DC voltage to provide a current of alternating polarities ; a microprocessor for controlling frequencies and voltages of alternating polarities and for calculation; a sacrificial electrode ( 24 ), which serves as a power distribution element, is connected to the power supply unit and the microprocessor and whose oxidation or reduction requires a voltage which is lower than the voltage required for a significant water electrolysis; an ionic layer ( 25 ), between the serving as a current distribution element sacrificial electrode 24 and the semipermeable membrane 26 is arranged, wherein in the ionic layer ( 25 ) Counterions can be contained, which coincides with those under an electrochemical action by the sacrificial electrode 24 generated, other ions can connect and therefore can produce the insoluble or the electrically neutral counterions of a final product; a semipermeable membrane ( 26 ) made of a material which can select the polarities of the ions themselves, the semipermeable membrane ( 26 ) it allows the ions coming from the organism or the ions, which have an electrical opposite polarity to those of the medicaments, to flow in a single direction into the ionic layer ( 25 ) enter; a drug zone ( 27 ) passing through the semipermeable membrane 26 from the ionic layer ( 25 ) and in which appropriate drugs are contained; an underclass ( 29 ) close to one of the drug zones ( 27 ) is located adjacent to and allows a passage of the drugs or substances to be used; and a flexible heat generator ( 28 ), which is connected to the power supply unit via a connection cable and with which the area of the skin to be treated can be heated. Composite, flexible iontophoresis heater according to claim 1, characterized in that in the drug zone ( 27 ) the water-soluble drugs are contained in a dosage form to provide molecules of the water-soluble drugs. Composite, flexible iontophoresis heater according to claim 1 and / or 2, characterized in that the drug zone ( 27 ) add the positively or negatively charged drugs. Composite, flexible iontophoresis heater according to one of claims 1 to 3, characterized in that the positive or negative charged after switching drugs into the drug zone ( 27 ) reach. Composite, flexible iontophoresis heater according to one of claims 1 to 4, characterized in that the flexible heat generator ( 28 ) continuously provides a temperature of 40 to 60 ° C.

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