JPH02218375A - Interface for electric percutaneous medication - Google Patents

Abstract

PURPOSE:To carry out the electrical percutaneous medication in the optimum state of the skin fine hole structure such as sweat gland by constituting the title interface from the nonconductive material having the porous or capillary structure. CONSTITUTION:An interface forming means 1 is made of the nonconductive material such as ceramics or a various sorts of synthetic resin material which has a capillary or porous structure and has an average hole diameter of several mum - several hundred mum and a porosity of 30-90%. A connector 3 for the connection with an electric lead wire 4 extending from a power supply unit 3 including an outer battery source is installed onto an electrode 2. After the interface forming means 1, etc., are attached onto a living body skin surface, a dc voltage or pulse voltage is outputted from the power supply unit. The interface forming means 1 shifts the liquid which receives the voltage and is positive-electrified in the sweat gland direction, and when the liquid intrudes into the sweat gland, the sweat gland forms an electric conductive path for connecting the inside and outside of the living body. Therefore, the succeeding electric percutaneous medication process such as iontophosresis can be achieved effectively.

Description

DETAILED DESCRIPTION OF THE INVENTION The present invention provides electrical cinnamate administration (iontophoresis, etc.)
This invention relates to a skin contact interface (skin contact body) for

Iontophoresis has recently been increasingly developed as a type of active transdermal drug delivery system.

However, the relationship between transdermal medication and biological passageways (sweat glands, etc.) that are presumed to be used for transdermal permeation of polymeric drugs such as peptides, that is, epidermal micropores, has not yet been fully elucidated. situation.

In view of the above, the main object of the present invention is to provide a means for bringing skin pore tissues such as sweat glands into an optimal state for electrical transdermal medication such as iontophoresis.

That is, according to the present invention, a conductive path is formed by effectively filling biological passages such as sweat glands with liquid mainly due to the electroosmotic effect of the interface, thereby achieving the above object. There are generally 2 to 5 million sweat glands in humans, and they are single-tubular glands with glandular bodies located in the dermis or subcutaneous connective tissue that are curved and shaped like globules, and the excretory ducts are spiral-shaped and extend on the surface of the epidermis. Opening (5udorifersous pore)
) has a structure.

Furthermore, the outer surface of the wire rod is surrounded by delicate smooth muscle fibers, which are further surrounded by a dense capillary network formed by branches from cutaneous arteries. For this reason, sweat glands can be used as a kind of electrically conductive biological passageway, and also have a close range for transporting medicinal fluids to the blood.

However, although sweat glands are pores opened to the outside as described above, gases with high electrical impedance, such as the atmosphere and various gases, usually exist near the outlet and the exhaust pipe.

In particular, when biological electrodes are applied to a living body to apply electricity for various purposes, gas is trapped between the electrodes, and sweat glands with gas present are in a state of high electrical impedance, effectively As a non-conductive path, it cannot contribute to iontophoresis of drugs, etc.

Electroosmosis is a phenomenon in which a liquid is divided into two chambers by a capillary tube or a substance with a porous structure, and when electrodes are placed in both chambers and a DC voltage is applied, the liquid moves. The direction of movement of this liquid is determined by the sign of the ξ-potential between the liquid and the substance.

Therefore, the subject matter of the present invention is to construct an interface (interface forming means) by impregnating a non-conductive substance having a capillary or porous structure with a liquid such as a medicinal solution, and to bring this interface forming means into contact with the surface of living skin tissue. The pores of the interface forming means and the sweat glands are connected, and a DC voltage or a pulsed voltage is applied thereon to produce an electroosmotic effect, thereby filling the sweat glands with liquid and forming a conductive path. Then, the purpose is to effectively carry out an electrical transdermal drug administration process such as conventional iontophoresis.

The porosity of the interface forming means is selected as appropriate depending on the purpose, but is usually set so that the sweat glands of the living body and the pores of the interface forming means communicate with each other with a high probability, about 30% to 90%. is generally good.

The interface forming means is selected to be used on the anode side or the cathode side depending on whether the zeta potential of the pore is positive or negative during charging.

For example, if the interface forming means is positively charged, the liquid will be negatively charged, so the interface forming means is arranged on the cathode side. or,
If the interface forming means is negatively charged, the liquid will be positively charged, so the interface forming means is placed and used on the anode side.

Embodiments of the present invention will be described in detail below with reference to the drawings.

FIG. 1 is a diagram showing an embodiment of the present invention.

(1) is an interface forming means, which is made of a non-conductive material such as a ceramic material having a capillary or porous (continuous pore) structure or various synthetic resin materials. Generally, the average pore diameter in the capillary or porous structure is preferably several μm to several hundred μm, and the porosity is generally preferably about 30 to 90%, as shown above.

Note that the pore size and porosity are appropriately selected depending on the number of sweat glands in the applicable skin, the dose of the drug used, etc., and are not particularly limited.

Here, the ceramic material refers to all porous materials produced in the ceramic industry, such as porous alumina and unglazed ceramics.

On the other hand, synthetic resin materials include propylene, polyethylene,
There is no particular limitation, as long as it is made of vinyl chloride, silicone, etc., and has a structure that has an electroosmotic effect such as porousness or capillarity.

Note that a capillary structure obtained by laser processing a ceramic material, a synthetic resin material, or the like may also be suitably used. Further, the thickness of these materials is not particularly limited, but is usually 0.1 mm to
It is about 10 mm.

(2) is an electrode, which is made of a conductive material such as various metals and carbon. In FIG. 1, the 'rJX electrode (2) is shown as having a single layer structure, but it may also have a structure in which a reservoir containing a chemical solution for iontophoresis is interposed in the middle, and the conductive member described above is further laminated thereon.

For ease of handling, a backing layer made of an insulating material may be disposed on the outermost layer of the electrode (2).

Furthermore, a normal gel-like biological electrode may be used as the electrode (2).

The electrode (2) is provided with a connector (3) for connection to an electrical lead (4) extending from a power supply unit (3) containing an external battery power source.

In addition, the miniaturized power supply unit described above is combined on the electrode (2), and the interface forming means is given adhesiveness or an adhesive layer is placed around it, so that the whole can be attached to the skin. It may be configured as follows.

It should be noted that these interface forming means are preferably made of a hard material, but may be made of a flexible film or sheet material depending on the case (that is, if the capillary tube or the like is non-deformable).

Next, the manner of use of the embodiment having the above configuration will be explained in detail.

FIG. 2 includes an anode part (LK) having the structure of FIG. 1, a cathode part (IF) showing a laminated structure of a conductive adhesive gel layer (8) and an electrode (9), and a power source such as a battery. A power supply unit (5) that outputs DC voltage or pulses, and a lead wire (4) for electrically connecting the anode part (IK), cathode part (IF), and power supply unit (5). The combination configuration is shown.

In FIG. 2, the anode part (IK) and the cathode part (IF) are shown in contact with the living body's skin surface (6).

In FIG. 2, after the interface forming means (1) and the like are brought into contact with the surface of the living body's skin, a DC voltage or a pulse voltage is output from the power supply unit.

The interface forming means (1) receives this voltage and moves a positively charged liquid such as a medicinal solution toward the sweat glands, the liquid enters the sweat glands, and the sweat glands become conductive paths connecting the inside and outside of the body. As a result, subsequent electrical transdermal drug administration processes such as iontophoresis can be effectively achieved.

As described in detail above, the present invention fills the sweat glands with liquid by electroosmotic effect to create a conductive path, enables electrical transdermal administration from the sweat glands, and also provides good conductivity between the external power source and the skin tissue of the living body. Since it is a channel, it does not cause excessive polarization and has the effect of eliminating the risk of burns and the like.

Next, an experimental example of the present invention will be explained in detail with reference to the drawings.

The interface forming means was made of an unglazed material with a porosity of 60% and a size and thickness comparable to that of an IO yen coin. This interface forming means was impregnated with a 10% aqueous solution of lidocaine hydrochloride. Note that a carbon material sheet was used as the electrode.

Pulse depolarization method iontophoresis (pulse peak value, 12V, frequency 40k) disclosed in Japanese Patent Application Laid-Open No. 58-159076
llzSduty 3% depolarization pulse wave) is used as a power supply unit, and the power supply unit (
+) was connected to the connector of the above electrode via a conductive wire. A gel bioelectrode for ECG was connected to the other output side.

The interface forming means and the ECG electrode were brought into close contact with the human right upper arm at an interval of 5 cm, and the (+) contact area was punctured with a needle at regular intervals to confirm the degree of subcutaneous anesthesia.

On the other hand, using absorbent cotton impregnated with a 10% aqueous solution of lidocaine hydrochloride as an interface forming means, it was brought into contact with the human left upper arm at a distance of 5 cm, and the same power supply unit as above was used, and the same stimulus was applied to the subcutaneous tissue. The degree of development of anesthesia was measured.

As a result, it was confirmed that strong subcutaneous anesthesia developed in 6 minutes when unglazed material was used as the interface formation means, but weak anesthesia was observed even after 20 minutes when absorbent cotton was used as the interface formation means. I stayed there.

In addition, if the above-mentioned interface forming means is used on the (-) side, it becomes possible to aspirate body fluids, thereby making it possible to construct a non-invasive biosensor. Including.

[Brief explanation of the drawing]

FIGS. 1 and 2 are diagrams showing embodiments of the present invention. l......Interface forming means, 2...
・・・・・・・・・・・・Electrode, 3 ・・・・・・・・・・・・Connector, 4 ・・・
・・・・・・・・・Electric lead wire, 5 ・・・・・・
・・・・・・Power supply unit, 6 ・・・・・・
・・・・・・・・・Biological skin surface, 7 ・・・・・・・・・
・・・・・・Connector, 8 ・・・・・・・・・・・・・・・
Conductive adhesive gel layer, 9: Electrode, 1K: Anode section, IF: Cathode section. Patent applicant Advance Co., Ltd.

Claims (1)

[Claims] (1) An electrical transdermal drug interface characterized by being made of a non-conductive material having a porous or capillary structure.