JPH0349589B2 - - Google Patents

Description

DETAILED DESCRIPTION OF THE INVENTION The present invention relates to a device for iontophoresis.

Iontophoresis has recently attracted increasing attention as an effective local administration method for promoting transdermal absorption of ionic drugs (Glass James et al., International Journal of
Dermatology (Glass JM et al., Int.J.
Dermatol.) 19 519 (1980); Russo J. ,
American Journal of Hospital Pharmacy (Russo J., Am.J.Hosp.Pharm.) 37
843 (1980); Gangarosa L.P. et al. , Journal of Pharmacological Experiments and Therapy (Gangarosa L Pet
al., J.Pharmacol.Exp.Ther.) 212 377 (1980);
Kwambiyes et al. , Journal of Infectious Diseases (Kwon BS et al., J.
Infect.Dis.) 140 1014 (1979); Hill GM et al. , Annual of the New York Academy of Sciences (Hill JM et al., Ann.
NY. Acad. Sci.) 284 604 (1977) and Tannebaum M. , Physical Therapy (Tannebaum M., Phys.Ther.) 60 792 (1980),
and so on)).

Iontophoresis in these prior art technologies usually involves connecting the output terminal of a continuous current generator or an intermittent current generator to a conductor such as a conductor such as a metal plate covered with absorbent cotton impregnated with a chemical solution, or a similar structure. Since it is done by connecting it to a guan inductor, it is quite complicated to implement, and although it is an extremely effective medication method, its widespread use has been limited. In addition, this iontophoresis is used by using a continuous or intermittent current that has the same polarity as the drug to be administered, but the skin has resistance (as shown in the skin equivalent circuit diagram in Figure 1). It has Rs. This resistance (Rs) is extremely high when continuous current is used, so in order to administer the amount of drug necessary for treatment, a high voltage must be applied to the skin, which causes irritation to the skin. It was strong and there was a risk of causing burns, redness, etc. Furthermore, it has been extremely difficult to administer the required amount when low voltage is used to prevent damage to the skin.

Furthermore, it is known that the resistance (Rs) of the skin (S) changes depending on the frequency of the applied power source.
(Yamamoto et al., Medical and Biological Engineering and Computation (Yamamoto, et al., Med. & Biol.Eng.
& Comput., ) (1978) 16.592−594; Yamamoto et al. ,
Medical Electronics and Bioengineering (1971) Vol. 11 No. 5
337-342.)) The trajectory of this change is roughly shown in Figure 2. That is, in the figure, the vertical axis represents the resistance Rs [KΩ] of the skin (S), and the horizontal axis represents the frequency [Hz] of the applied power source. As is clear from this figure,
Skin resistance (Rs) has the characteristic of decreasing as the power frequency increases. Skin resistance (Rs) varies greatly from person to person, and changes depending on temporal oscillations and diurnal cycles, so it is difficult to display an absolute value. For example, when the frequency is 0 [Hz], skin resistance (Rs)
is about 100 [KΩ], about 70 at 100 [Hz]
[KΩ], approximately 20 [KΩ] at 1000[Hz] or 10000[Hz]
In this case, the resistance decreases to about 8 [KΩ]. When a high-frequency power source is applied to the human body in this way, the skin resistance (Rs) decreases, making iontophoresis possible at a low voltage. Resistance (Rs) as shown in
Since the capacitor (Cs) is represented by a parallel circuit of the capacitor (Cs), even if a DC pulse voltage as shown in Figure 3a is simply applied, the capacitor (Cs) will repeatedly charge and discharge, and when the pulse output is stopped, the capacitor (Cs) will be charged and discharged. As the residual charge (polarization) is discharged (depolarization) extremely slowly through the resistance (Rs), the current associated with drug introduction is substantially the same as when using continuous current, as shown in Figure 3b. There was no change in the skin resistance, and simply applying a high-frequency DC pulse voltage could not cause a decrease in skin resistance. That is, the resistance of the skin (Rs) and the capacitor (Cs) vary from person to person, but are usually about 50 [KΩ] and 0.1 [μF], respectively. Therefore, the time constant is 0.1×10 ^-6 ×10×
10 ³ = 10 ^-2 , which is on the order of several milliseconds. This indicates that it takes several milliseconds for the current value to drop to about 1/3, and therefore, for pulses of several hundred [Hz] or more, the current waveform is essentially the same as when using continuous current, Therefore, no decrease in skin resistance could occur.

In addition, as shown in Figure 3c, the output time of the DC pulse voltage is shortened, and even if residual charge (polarization) occurs due to the capacitor (Cs), the interval between pulse rest times is increased until the current value becomes sufficiently low. It is possible to lower the skin impedance by reducing the duty ratio, but this poses a problem in terms of introduction efficiency because residual charge (polarization) is a charge that remains on the skin and is not involved in drug administration. It was hot.

The present invention solves the above-mentioned drawbacks, and can sufficiently lower the skin resistance, thereby enabling use at low and high voltages, and as a result of depolarization, there is less irritation to the skin, causing burns and redness. The purpose of the present invention is to provide a safe device for iontophoresis that is free from such risks.

A further object of the present invention is to provide a small and lightweight iontophoresis device, particularly an iontophoresis device that is extremely easy to operate and has a lightweight structure that can be directly attached to human skin.

Hereinafter, a first embodiment of the present invention will be described in detail with reference to FIGS. 4 and 5 of the drawings.

In FIG. 4, numeral 10 is an iontophoresis device shown in a block diagram. 2 is a power source, for example, a 6 [V] dry cell battery, and 3 is a pulse oscillation mechanism. 4 is a seki conductor containing an ionic drug, and 5 is a non-seki conductor. Reference numeral 6 denotes a human body connected to the above-mentioned Kankan conductor 4 and Insenkan inductor 5. The pulse oscillation mechanism 11 has, for example, 10,000
Treatment pulse voltage of about [Hz] 12, 12, 12,
... as well as this therapeutic pulse voltage 12,
When the conductors 12, . . . stop, pulse voltage components 13, 13, 13, . This pulse voltage component 1 in the opposite direction
The therapeutic pulse voltages 12, 12, 3, 13, . . .
The residual charge (polarization) charged during the output time of ... is forcibly discharged (depolarized) at the same time as the treatment pulse voltage 12, 12, ... rests, and the skin (S) of the human body 6 is charged as shown in Figure 5b. Current flows. Due to this current, the ionic drug contained in the conductor 4 is absorbed through the skin through the skin resistance (Rs) shown in the skin equivalent circuit diagram of FIG.

For example, as in the example, when the power supply voltage is 6 [V] and a therapeutic pulse voltage of about 10,000 [Hz] is applied to the human body 6, the human body 6 is subjected to a simple operation that does not output a pulse voltage component in the normal direction or in the opposite direction. Compared to when using intermittent pulses, about 10 times more current flows at peak times.

In the above embodiment, a configuration was described in which the treatment pulse voltage and the forced discharge pulse voltage component are outputted by one pulse oscillation mechanism, but the configuration is not limited to this, and for example, each pulse may be oscillated independently. It may be configured such that the signal is output and applied to the human body by synchronizing both.

Furthermore, a mechanism may be provided to arbitrarily or automatically control the time and voltage of the forced discharge pulse component in order to depolarize between both conductors.

Furthermore, in the above embodiment, a configuration was described in which a pulse is output in the opposite direction to depolarize between both conductors, but the structure is not limited to this means, and means having a similar effect may be provided. Any configuration may be used.

Furthermore, the power supply voltage, the voltage waveform of the therapeutic pulse, the pulse width, the oscillation frequency, etc. may be arbitrarily changed depending on the characteristics and application of the drug to be introduced, but usually the duty ratio is 0.2 to 0.7 and the repetition frequency is 1KHz. Values on the order of ~200KHz may be adopted.

In other words, since the present invention only needs to be capable of pulse treatment as a result of depolarization, various pulse modes commonly used in the field of electrotherapy can be suitably selected and implemented within this scope. It is clear that there is.

In addition, the degree of depolarization referred to in the present invention is sufficient as long as the residual polarization voltage that is constantly applied to the skin does not cause skin irritation (stimulation), and the usage conditions such as the pulse voltage used etc. However, as shown in each example, a range in which the depolarization current value becomes a steady value substantially close to zero level is particularly preferable.

On the other hand, it will be clear as shown in the usage examples below that a constant steady bias voltage or the like may be further applied at the same time as the pulse voltage, as long as it is within a range that does not cause skin irritation.
That is, pulsed iontophoresis and weak plain current iontophoresis (galvanization) can be used together within the above range.

Further, in the above embodiments, a general example of the skin equivalent circuit has been described, but substantially the same can be said when considering the electrical characteristics of the conductor.

As is clear from the above explanation, according to the iontophoresis device of the present invention, when the same power supply voltage is applied, the iontophoresis device of the present invention has a power of about 10 times to several 10 times as much as that of a device using continuous or simply intermittent current. A current flows, and even if the treatment pulse rest time and the loss of polarization, that is, the loss of current charged in the capacitor (Cs) are taken into account, the effect of introducing the ionic drug can be several times to several tens of times greater. In addition, because the required amount of drug can be administered at a low voltage, or as a result of depolarization, irritation to the skin is extremely weak, and there is little risk of burns or redness. An iontophoresis device suitable for use over time is obtained.

In particular, if the configuration is such that a pulse component in the opposite direction is output during the pause period of the treatment pulse voltage as in the embodiment, the influence of the above time constant due to the resistance component of the circuit is extremely small, and the pause of the treatment pulse voltage is relatively short. Since the area between both conductors is depolarized during this period, a high frequency DC pulse can be used, and a device capable of iontophoresis with lower skin impedance can be obtained.

Although periodic pulses have been described above from a practical standpoint, it goes without saying that essentially the same effect can be obtained even with non-periodic pulses.

Furthermore, the circuit is configured by combining a charge pump type booster circuit and an output current limiting circuit with a circuit that depolarizes between both conductors by outputting a pulse component in the opposite direction at the same time as the treatment pulse stops. It's okay. Alternatively, the booster circuit and the current limiter circuit may be provided with only one of them, or may be provided with neither the booster circuit nor the current limiter circuit.

In addition, as an example of a power supply voltage boosting mechanism, a structure using a charge pump type booster circuit has been described, but the invention is not limited to this. It can be anything.

As is clear from the above description, according to the iontophoresis device according to this embodiment, a boosting mechanism is provided in the pulse oscillation mechanism, so that good therapeutic effects can be obtained even when a low voltage power source is used.

In particular, if a button-shaped battery of several [V] is used as in the example, and a charge pump type booster circuit is used as the booster mechanism, the volume can be made extremely small. It can be extremely suitable as a circuit for a device.

Furthermore, if an output current limiting circuit is provided as in the embodiment, a device can be obtained which can limit the large peak current flowing through the human body at the rising and falling edges of a treatment pulse, and can significantly reduce shock. Furthermore, by inserting a variable resistor into the output current limiting circuit and configuring the device to control the output current, it is possible to obtain a device that can perform treatment with an optimal current regardless of individual differences in impedance.

Next, an example of the overall configuration of the iontophoresis device of the present invention will be described in detail below.

FIGS. 6 and 7 show a first embodiment. In the figure, reference numeral 30 denotes an iontophoresis device that is integrally attached to the skin, that is, in the form of a plaster, and has a separator 31 and a separator 32.
The Kanden electronics 31 includes an ionic drug-containing conductive gel layer 33 formed in the form of a flexible sheet or film;
It is integrally formed by laminating a current dispersion conductive member layer 34 made of metal foil such as aluminum foil, conductive rubber or resin film, carbon film, conductive paint, or the like. Further, the indifferent conductor 32 is integrally formed by laminating a conductive gel layer 35 formed in the shape of a flexible sheet or film and a current dispersion conductive member layer 36 formed of aluminum foil or the like as described above. It was formed. A power supply unit 37 is installed approximately at the center of the upper surface of the conductor 31. This power supply unit 37 includes a power source, for example, a so-called button-shaped battery, a pulse oscillation mechanism, and means for depolarizing both the conductors 31 and 32 when the treatment pulse of this pulse oscillation mechanism is stopped. One of the output terminals, for example, the (-) terminal, is installed so as to be in contact with the current dispersion conductive member layer 34. Further, the (+) terminal of the power supply unit 37 is connected to the current dispersion conductive member layer 3 of the indifferent conductor 32 by a lead wire 38 made of, for example, aluminum foil, whose lower surface except near both ends is coated with an insulator.
6. 39 is an insulating backing layer. The insulating backing layer 39 is made of, for example, a non-conductive synthetic resin in the form of a flexible sheet or film.
2 are spaced apart and fixed to this insulating backing layer 39. That is, the inductor 31, inductor 32, and power supply unit 37 are integrally supported and connected by the insulating backing layer 39.

Next, the operation and usage of the ionophorase device constructed as described above will be explained. First, the guide element 31 is attached so as to be in contact with the desired treatment position on the human body. At the same time, the inductor 31 and the inductor 32 form a closed circuit, pulse oscillation is started, and the ionic drug in the ionic drug-containing conductive gel layer 33 of the inductor 31 permeates through the skin. is accelerated.

According to this example, an iontophoresis device can be obtained which is extremely easy to operate and lightweight, and which can be directly attached to the human skin, and which can provide a sufficient drug administration effect.

Next, with reference to FIGS. 8 and 9, a second embodiment in which the iontophoresis device of the present invention is configured to be integrally attached to the skin, that is, in the form of a plaster, will be described in detail. In the figure, 40 is an iontophoresis device, and 41
indicates a seki conductor, and 42 indicates an insensitivity conductor. This Seki Doiko 4
1 and the conductive member layer 4 for current dispersion of the unrelated conductor 42
3 and 44 are arranged at a distance of about 5 mm, and an ionic drug-containing conductive gel layer 45 formed to be extremely thin, for example, about 0.3 mm is adhered to the lower surface thereof. In addition, Inkan Doko 42 and Seki Doko 43
are integrally supported and connected by an insulating backing layer 46. 47 and 48 are respectively Seki Doiko 41,
This is a terminal connected to the indifferent conductor 42. The tops of these terminals 47 and 48 are connected to the insulating packing layer 46.
The power supply unit 49 is electrically connected and mechanically supported and connected by these terminals 47 and 48.

The method of using the iontophoresis device of this example is the same as that of the first example, so the description thereof will be omitted. According to this embodiment, the Seki conductor 41 and the Inkan conductor 4
Since the conductive gel layers laminated in the conductive gel layers 2 and 2 are the same, i.e., one ionic drug-containing conductive gel layer 45 is attached to each of the current dispersion conductive member layers 43 and 44, there is a slight gap between each conductor. However, since the conductive gel layer itself has resistance and the distance between the conductive member layers 43 and 42 is extremely large compared to the thickness of the conductive gel layer 45, the ionic drug does not penetrate the skin. It has almost no effect on the effect.

According to this embodiment, in addition to the effects of the first embodiment, the manufacturing process is extremely simple and efficient. In other words, a device can be obtained by simply attaching terminals and a power supply to a single belt-shaped sheet in which a conductive gel layer, a conductive material layer, and an insulating backing layer are laminated and cut at predetermined intervals, and mass production is possible. This has a very useful effect when considering the following. Furthermore, if the spacing between both terminals is narrowed and the power supply is placed approximately in the center of the top surface of the device as in the example, the size of the power supply has almost no effect on the entire device, and it can be attached to the curved surface of the human body. It can be used satisfactorily with almost no loss in flexibility even when

Next, a third embodiment of the iontophoresis device of the present invention will be described in detail with reference to FIG. 10 of the drawings. In the figure, 51 is a device for iontophoresis, and 52 is an indifferent conductor. Reference numeral 54 denotes a power supply, the (-) terminal of which is connected to the current dispersion conductive material layer 55 of the conductor 52, and the (+)
The terminal is connected to the current dispersion conductive member layer 57 of the indifferent conductor 53 via a lead wire 56.

According to the configuration of this embodiment, the guan conductor and the guan conductor can be attached to the human body at any distance within the length of the lead wire, and when the attachment site is small or has a relatively large curvature. It can also be used easily on surfaces such as Furthermore, even when the skin sweats profusely due to use in hot and humid conditions, a plaster structure can be obtained that is completely unaffected by the current flowing through the epidermis because the conductors are separated from each other.

Next, a fourth embodiment of the iontophoresis device of the present invention will be described in detail with reference to FIG. 11 of the drawings. In the figure, 61 is a device for iontophoresis, 62 is an inductor thereof, and 63 is an inductor thereof. Both conductors 62 and 63 are connected to a power supply 65 via a lead wire 64. This power supply 65 is equipped with, for example, four AA batteries, a pulse oscillation mechanism using a transformer, and a switch mechanism for depolarizing both conductors 62 and 63 when the treatment pulse is stopped. ing. Furthermore, this power supply 65 includes an output current variable circuit and a timer circuit.

According to this embodiment, since the power supply is separate from both conductors, the circuit space can be increased and a large capacity dry cell battery can be used. Furthermore, since both conductors are simply film-like ultra-light sheets, it is extremely easy to attach them to the human body. Furthermore, since a variable output current circuit is installed, the amount of output current can be controlled arbitrarily depending on the skin resistance of the user, the type of drug to be introduced, the required amount, etc. Furthermore, since a timer circuit is provided, it has the advantage of being able to prevent excessive administration of drugs.

In the above example, a conductive gel containing an ionic drug was used as the conductor, but the present invention is not limited to this.
Paper materials such as water supply paper, cloth materials such as gauze, fiber materials such as absorbent cotton, sponges or porous materials such as open synthetic resin foam or water-absorbing resin, as long as they can be impregnated with and retain ionic drugs or electrolyte solutions. It can be anything. In addition, in the examples, the conductive gel layer of the conductor was described as containing an ionic drug in advance, but the ionic drug was applied to the conductor and/or the skin during use. Also good. That is, a conductive gel layer that does not contain an ionic drug is used, and at the start of treatment, an ointment, cream, etc. containing an ionic drug is applied to the conductor and/or the skin to form the skin. It may also be an iontophoresis device to which a conductor is attached for treatment. Furthermore, a polarity switching means may be added to the device so that the yin and yang of the conductor can be freely changed depending on the yin and yang of the effective drug ion species.

In addition, especially when the biological condition changes depending on the drug dose, or when the drug dose must be controlled according to the biological condition, the output current can be automatically adjusted while monitoring the biological condition. It may also have a configuration in which a feedback mechanism for controlling the speed is internally provided. For example, when it is necessary to control the dose based on the blood sugar level, especially when administering insulin, a sensor that monitors the blood sugar level can be connected to the power supply, and the detection output of this sensor can be used to automatically control the dose. A feedback mechanism for controlling output current and/or output time may be provided. With this configuration, it is possible to perform optimal drug administration according to the biological condition, which was impossible with conventional administration methods.

Each component of the plaster structure of this example will be explained in more detail as follows.

Conductive gel layer This layer is preferably made of natural resin polysaccharides such as karaya gum, tragacanth gum, and xanthan gum, or partially saponified polyvinyl alcohol, vinyl resins such as polyvinyl formal, polyvinyl methyl ether and its copolymers, polyvinyl pyrrolidone, polyvinyl methacrylate, etc. Polyacrylic acid and its sodium salt, polyacrylamide and its partially hydrolyzed product, partially saponified polyacrylic ester, poly(acrylic acid-acrylamide)
Various hydrophilic natural or synthetic resins, such as acrylic resins, are softened and plasticized with water and/or alcohols such as ethylene glycol and glycerin to produce flexible films or sheets that have self-shape retention and skin adhesion. Supplied as a gel.

On the other hand, an electrolyte such as sodium chloride, sodium carbonate, potassium citrate, etc. is added in a required amount (usually about 1 to 15%) to provide sufficient conductivity. The conductive gel layer suitable for the present invention obtained in this way is in the form of a flexible film or sheet and can adhere to the skin, so it has low skin contact resistance and is effective for percutaneous penetration of drug ions. Not only that, but it also has the advantage of being able to adhere and support the entire structure to the skin without requiring other skin adhesion means such as adhesive tape. In particular, when a natural resin polysaccharide such as the aforementioned Karaya gum is used as a base material for the gel layer, its natural polymeric acid structure provides PH buffering and skin protection properties, extremely high water retention capacity, moderate skin adhesion, etc. Not only can a gel with good electrochemical conductivity be provided, but also suitable skin compatibility can be obtained.

In addition, when formulating the composition of these gel layers, it goes without saying that electrochemical considerations should be made in much the same way as in the case of so-called electrophoresis gels, but the main consideration is the type of drug used and the required dosage (dose). ), the application time, the output of the battery used, the skin contact area, etc., are appropriately carried out so that the ion mobility or conductivity reaches the required value.

Here, the preferred conductive gel layer in this example, as well as some more specific examples, are as follows: 1. The average molecular weight is 440,000, and the degree of saponification is approximately 60 using a conventional method.
Prepare 30g of % polyvinyl alcohol powder,
To this, 40 g of distilled water containing 10% NaCl and 30 g of glycerin, which had been preheated to 80°C, were added and stirred.
The resulting mixture was then heated and pressed for about 20 minutes at a pressure of 0.6 kg/cm ² using a hot press heated to 80° C. to obtain a flexible sheet with a thickness of 3 mm.
This flexible sheet-like material has sufficient skin adhesion and its DC specific resistance (hereinafter the same) is 0.8KΩ・
It was cm.

2 A flexible sheet-like conductive gel layer was manufactured using the following composition in the same manner as in 1 above.

Composition example A Polyvinylpyrrolidone (PVP-K90 manufactured by GAF;
Average molecular weight: 360,000) ...20 g Distilled water containing 10% NaCl ...40 g Glycerin 40 g The obtained sheet had strong skin adhesion and its specific resistance was 0.2 KΩ·cm.

Composition example B Polyvinyl formal (average molecular weight 1.6 million, formalization degree 15%; saponification degree of raw material polyvinyl alcohol 60%) ...15g Distilled water containing 5% NaCl ...70g Propylene glycol ...15g The obtained sheet is sufficient It had good skin adhesion and its specific resistance was 1.0KΩ·cm.

Composition example C Polyvinyl acetoacetal (average molecular weight 440,000,
Degree of acetalization: 30%; degree of saponification of starting polyvinyl alcohol: 70%...40g Distilled water containing 15% NaCl...50g Ethylene glycol...10g Has sufficient skin adhesion and has a specific resistance of 0.75KΩ.
cm.

3. Mix 20 g of sodium polyacrylate (Aronbis SS manufactured by Nippon Pure Chemical Industries, Ltd.; average molecular weight 3 million to 5 million) with 12 g of distilled water containing 5% NaCl and 68 g of glycerin solution, and soften by heating and pressurizing at 80°C for 10 minutes. A sheet-like product was obtained. This sheet has moderate skin adhesion and has a specific resistance of 1
It was 0.5KΩ・cm after being left for day and night.

4 30g of Karaya gum and 30g of distilled water containing 5% NaCl
and 40 g of glycerin were mixed and heated and pressed to prepare a sheet in the same manner. Specific resistance 0.65KΩ・cm.

5 Sodium polyacrylate (Aronbis S manufactured by Nippon Pure Chemical Industries, Ltd.; average molecular weight 3 million to 5 million) 20 g 7%
A sheet was prepared in the same manner by mixing with 80 g of NaCl-containing purified water and applying heat and pressure. Specific resistance 0.47KΩ・cm.

In particular, from an electrochemical point of view, basic drugs such as propranolol, insulin, lidocaine, cysteine, etc. are treated with polyacrylic acid, methyl vinyl ether/maleic anhydride copolymer (G.
GANTREZR AN-169 manufactured by AF, etc.) Carboxypolyethylene (CARBOR POL manufactured by GOODRICH)
etc.), ascorbic acid, salicylic acid, nitrous acid, riboflavin phosphate, betamethasone phosphate, tretinoin (trans-
It will be understood that highly efficient transfer of target drugs can be achieved by using basic polymers such as polyacrylamide as the gel base for acidic drugs such as retinoicacid.

For example, an example of a gel composition for propranolol is as follows.

Carbopol R 491 or GANTREZ AN-169 30 parts by weight Glycerin 45 parts by weight Water 15 parts by weight Propranolol 10 parts by weight Furthermore, this gel composition is made into a self-adhesive film with a thickness of approximately 0.1 to 0.5 mm. As mentioned above, it is extremely suitable for use as a film electrode with integrated conductors and conductors.

Furthermore, it will be appreciated that non-ionic polymers such as polyvinyl alcohol, polyvinylpyrrolidone, etc. may also provide gels with relatively high electrochemical efficiency.

As is clear from the above, the gel base material composition or range of the conductive gel layer of the present invention is not limited to a specific one, and a wide range of hydrophilic polymers can be softened and plasticized with water and/or alcohols. However, in order to have shape retention, the composition is usually selected within the range of 10 to 70% by weight of the hydrophilic polymer and the balance water and/or alcohol. Each of the above-mentioned conductive gel layers has sufficient skin adhesion by itself, but if desired, a pressure-sensitive adhesive component such as an acrylic adhesive or a vinyl acetate emulsion adhesive may be added. It's okay.

In this way, by arranging the skin-adhesive and conductive gel layer around the periphery or end of the structure, the entire structure can be attached to the skin without the need for any other fixing means such as adhesive tape. It is held fixed.

In addition, if the conductive gel layer is the husband of Seki Doko,
In each of the above gel compositions, it is sufficient to add and dissolve a required ionic drug in place of part or all of the electrolyte component, ie, sodium chloride. If necessary, the water-retaining member layer may be made removable, and the member impregnated with a drug in advance may be placed at a predetermined position in the structure and used for treatment. It is also obvious that non-adhesive hydrogels commonly used in the field of electrophoresis, such as agar gel and gelatin gel, may be used in place of the water-absorbing member. An example of an agar water gel composition is as follows.

Agar powder 4.0 parts by weight Purified water 100.0 〃 Vitamin C 5.0 〃 (Asconviric acid: its Na salt ~ 1:1) This kind of hydrogel pieces may be laminated and arranged in a structure in advance, or used as described above. It may be arranged at the same time.

In addition, when using a non-adhesive hydrogel such as agar gel in this way, it is natural that skin-adhesive fixing means such as adhesive tape may be optionally added to the outer extension of the structure in this example. It is.

Ionic drugs All ion dissociative drugs can be used, but
Some examples of those already widely used in the field of iontophoresis are as follows: iodopotassium, procaine hydrochloride, melicol, various skin vitamins such as vitamin B ₁ , B ₂ , B ₆ , C, and histamine. , sodium salicylate, dexamethasone, betamethasone phosphate, epinephrine, hydrocordisone, idoxolidine, propranolol, nitrites, bleomycin, undecylene hydrochloride, etc.

Usage Examples Examples and usage examples of the Kan inductor and the Inkan inductor of the iontophoresis device of the present invention will be described in more detail below.

That is, the conductive gel layer of both conductors is a viscoelastic gel with a thickness of 1.5 mm and an area of 48 cm ² consisting of 20% by weight of the aforementioned Carbopol® 491, 30% by weight of distilled water, and 40% by weight of glycerin. 5% by weight of sodium salicylate is further added to the secondary conductive gel layer containing an ionic drug, and about 3% by weight of sodium chloride is added to the conductive gel layer of the secondary conductor.

This is connected to a 6V power supply and used as an adhesive, laminated together with a power supply that outputs 4KHz therapeutic pulses.

The plaster structure in this usage example is used as an analgesic and anti-inflammatory agent, but in this case, so-called galvanization, which has a vasodilatory effect, is also performed, so it can be used to treat neuralgia, It will be understood that it shows a synergistic effect on diseases such as joint pain and rheumatoid arthritis.

It will also be clear that this type of plaster structure is useful for purposes such as the treatment of various skin diseases and the penetration of cosmetic nutrients. For example, the conductive gel layer of both conductors is prepared using GAR N TREZ AN-169 20% by weight, distilled water containing 20% NaCl15
Thickness consisting of 65% by weight and glycerin 65% by weight
It is made of a skin-adhesive viscoelastic gel with a size of 1.5 mm and an area of about 12 cm ^2. When using it, drop 1 to several ml of a 3% vitamin C-containing aqueous solution (stored in ampoules) onto the conductive gel layer of the seki conductor. After soaking, the entire structure is attached to the affected area and the treatment begins.

As is well known, vitamin C (ascorbic acid) or its derivatives (sodium ascorbate, etc.)
is effective for pigmentation disorders such as so-called melasma, sparrow spots, and various types of melasma, and treatment using iontophoresis is already known to be useful in cosmetics and dermatology. However, as mentioned above, it is not widely used due to the complicated operation. However, this example allows the treatment to be performed with extremely simple operations, and can be said to be revolutionary as a therapeutic or cosmetic plaster.

Other gel base materials Some preferred examples of the gel base material for the conductive gel layer of the present invention are as described above, but various hydrophilic polymer materials known as so-called biological electrode materials may also be selected at will. It is once again pointed out that it can be used. For example, JP-A No. 95895 of 1972, No. 77489 of 1974, No. 52742 of 1975, No. 81635 of 1975, No. 129035 of 1973, No. 15728 of 1972, No. 36939 of 1973, and 36940 of 1981. No.60534 of 1956, No.89270 of 1956, No.143141 of 1956, No.28505 of 1957, No.49431 of 1957, No.52463 of 1957, No.55132 of 1957, No.131428 of 1957, 160439 of 1957, 164064 of 1957, 166142 of 1957, 168675 of 1957, 4569 of 1957, 10066 of 1958, No. 80689 of 1972, 135706 of 1976, The various hydrophilic polymer materials disclosed in No. 138603 of 1995, No. 93305 of 1957, No. 179413 of 1957, No. 185309 of 1957, etc. can be used to improve the conductivity of the present invention by appropriately adjusting their water content, etc. It can be used as a gel base material for a gel layer.

As described above, the gel base material of the conductive gel layer of the present invention is a hydrophilic polymer which is softened and plasticized with water and/or alcohol to preferably provide a skin-adhesive viscoelastic gel. However, the base material composition is not limited to a specific material, and the composition of the base material is determined in consideration of compatibility with the drug used, skin compatibility, electrical conductivity, etc. Furthermore, these gel layers can be disposable or replaced with other materials.

[Brief explanation of drawings]

Fig. 1 is an explanatory diagram in which the skin is replaced with an equivalent circuit, Fig. 2 is a resistance drop characteristic diagram showing the relationship between frequency and skin resistance, Fig. 3 shows the waveform in conventional iontophoresis, and a is the pulse voltage. In the waveform diagram, b shows a current waveform diagram flowing through the human body when the waveform a is applied, and c shows a current waveform diagram when a pulse with a reduced duty ratio is applied. Fig. 4 is a block circuit diagram showing an embodiment of the iontophoresis device of the present invention, and Fig. 5 shows its waveform, where a is a pulse voltage waveform diagram, and b is a current waveform flowing through the human body when the waveform a is applied. Show the diagram. Figures 6 and 7
The figures show a first embodiment of the overall configuration of the iontophoresis device of the present invention, with FIG. 6 being a sectional view taken along the line XII--XII, and FIG. 7 being a bottom view. 8 and 9 show the second embodiment, and FIG. 8 shows -
A cross-sectional view along a line, FIG. 9 a perspective view.
10 and 11 show the third and fourth embodiments, FIG. 10 is a sectional view thereof, and FIG. 11 is a perspective view thereof. 10...Device for iontophoresis, 2...
...Power supply, 3...Pulse oscillation mechanism, 4...Doko Seki,
5...Indifferent conductor, 6...Human body, 12...Treatment pulse, 13...Reverse direction pulse component, 30, 40,
51,61...Device for iontophoresis,
31, 41, 52, 62... Seki Deiko, 32, 4
2, 53, 63... Indifferent conductor, 33, 45... Ionic drug-containing conductive gel layer, 35... Conductive gel layer, 37, 49, 54, 65... Power supply unit.

Claims (1)

[Scope of Claims] 1. In an iontophoresis device having a power source, a pulse oscillation mechanism, and an independent inductor and an independent inductor, the repetition frequency from the pulse oscillation mechanism is
An iontophotometer characterized by having a depolarizing means consisting of a pulse oscillation mechanism that outputs a pulse component in the opposite direction to the treatment pulse in order to depolarize between both the conductors during a treatment pulse voltage rest period of 1KHz to 200KHz. Reese device. 2. The iontophoresis device according to claim 1, further comprising a pulse oscillation mechanism having a voltage boosting mechanism for boosting the power supply voltage. 3. The iontophoresis device according to claims 1 and 2, characterized by comprising a pulse oscillation mechanism having an output current control circuit.