1. Technical Field
The present invention relates to a packaged iontophoresis system. In particular, the present invention relates to a packaged iontophoresis system hermetically packaging an iontophoresis system for transdermally delivering drug ions by iontophoresis.
2. Related Art
Japanese Patent Application Publication No. 2000-229128 discloses an iontophoresis system for transdermally delivering drug ions to biologic surfaces, such as skin or mucous membranes, of a predetermined part of a human or animal body by iontophoresis. Hereinafter, such skin and mucous membranes are collectively referred to as “skin”.
The iontophoresis system disclosed in Japanese Patent Application Publication No. 2000-229128 attempts to solve such problems as a decrease amount of ionic drug or drug-dissolving solvent from a container of the iontophoresis system due to volatilization, and corrosion of a power source such as a battery attributable to the vaporized drug solutions due to the volatilization, during storage prior to application of the drug ions to a patient. A possible solution thereof is to fix the power source of the apparatus body of the iontophoresis system to the package material to hermetically sealing them. In this case, however, the package material will be welded to a connection part between the power source and the apparatus body. This has caused a problem that the surface of the connection part is peeled off with the package material when opening the package material.
In view of this, it is an object of one aspect of the present invention to provide a packaged iontophoresis system capable of addressing the foregoing problems. This object may be achieved by combinations of features described in the independent claims. The dependent claims define further advantageous and concrete embodiments of the present invention.
According to one exemplary packaged iontophoresis system based on an aspect of the innovation herein, a packaged iontophoresis system includes an apparatus body for transdermally delivering an ionized drug by iontophoresis, and an iontophoresis device having a connection part extended from the apparatus body which is connected to a power source supplying power to the apparatus body; a package material hermetically packaging the apparatus body and a portion of the connection part by at least a portion thereof being fixed to the connection part; and a cutting guide for guiding a cutting line of the package material so that the part of the package material fixed to the connection part remains with the connection part when the package material is opened and removed. Accordingly, the package material can be opened to be removed without damaging the wiring of the connection part or the like.
In the above described packaged iontophoresis system, the cutting guide part may also include a groove in a thickness direction and provided between the portion thereof that is fixed to the connection part and the other portion thereof. Accordingly, when opening and removing the package material, the cutting guide is able to more assuredly guide the cutting line so that the part fixed to the connection part will remain at the connection part.
In the above described packaged iontophoresis system, the cutting guide part may also include a notch provided in the vicinity of the fixed part to the connection part. Accordingly, when opening and removing the package material the cutting guide is able to more assuredly guide the cutting line so that the part fixed to the connection part will remain at the connection part.
In the above described package material, preferably, the strength of the part fixed to the connection part is stronger than any other part of the package material. Accordingly, the package material can be opened to be removed, without damaging wiring in the connection part or the like.
The above described iontophoresis system may also have an apparatus body that includes: an operation electrode structure including a first electrode member and a drug solution retainer, the first electrode member being electrically connected to a first conductivity type terminal of the power source, the first conductivity type being the same as a conductivity type of the ionized drug, the drug solution retainer retaining a drug solution containing the drug and being provided in an electric field created by the first electrode member; and a non-operation electrode structure electrically connected to a second conductivity type terminal of the power source, the second conductivity type being opposite to the first conductivity type. Accordingly, iontophoresis can be applied to any drug solution containing a drug, without special preparations.
It is further possible to arrange the iontophoresis system so that the operation electrode structure includes: a first electrolyte retainer electrically connected to the first electrode member and retaining an electrolyte; an ion exchange membrane of the second conductivity type sandwiching the first electrolyte retainer with the first electrode member, and selectively transmitting ions of the second conductivity type; and an ion exchange membrane of the first conductivity type sandwiching the drug solution retainer with the ion exchange membrane of the second conductivity type, and selectively transmitting ions of the first conductivity type. Accordingly, not only can the skin to be in contact with the operation electrode structure be prevented from burns and inflammation, but also the drug ions can be applied while stably supplying electricity to the skin. This enables the drug ions to be applied to the living organism securely and efficiently.
It is further possible to arrange the iontophoretic system so that the non-operation electrode structure includes: a second electrode member electrically connected to the terminal of the second conductivity type of the power source; a second electrolyte retainer electrically connected to the second electrode member and retaining an electrolyte; an ion exchange membrane of the first conductivity type sandwiching the second electrolyte retainer with the second electrode member, and selectively transmitting ions having an electric polarity different from an electric polarity of the second electrode member; a third electrolyte retainer provided in an opposite side of the second electrolyte retainer in the ion exchange membrane of the first conductivity type, and retaining an electrolyte; and an ion exchange membrane of the second conductivity type sandwiching the third electrolyte retainer with the ion exchange membrane of the first conductivity type, and selectively transmitting ions having an electric polarity that is the same as the electric polarity of the second electrode member. Accordingly, not only can the skin to be in contact with the non-operation electrode structure be prevented from burns and inflammation, but also the drug ions can be applied while stably supplying electricity to the skin. This enables the drug ions to be applied to the living organism securely and efficiently.
The summary does not necessarily describe all necessary features of certain embodiments of the present invention. The present invention may also be a sub-combination of the features described above.
Some aspects of the invention will now be described based on the embodiments, which do not intend to limit the scope of the present invention, but rather, exemplify the invention. All of the features and the combinations thereof described in the embodiment are not necessarily essential to the invention.
It is preferable that the upper package material 82 and the lower package material 84 are water-impermeable and further substantially impermeable to gases body such as water vapor. The material may accordingly be an aluminum foil, a polyester film, a polypropylene film, a polyethylene film, or the like. When being welded by means of heat sealing, the upper package material 82 and the lower package material 84 may be a lamination of a plurality of the above-described films, or may be the above-described films with a polymer resin coating for facilitating peeling at the time of opening.
As in
As shown in
The method of fixing the upper package material 82 and the lower package material 84 is not limited to welding by heat sealing described above. Other alternative methods include attachment by means of a variety of adhesives, mechanical pressure bonding by means of clips and the like, or a combination thereof. Since the packaged iontophoresis system 15 is packed by the package material 80, the positioned nearer to the apparatus body 50 is more hermetically sealed than the apparatus body 50 of the iontophoresis system 10 and the connection-part welded surface 94 of the connection part 70. Decreases in the amount of ionic drugs or drug-dissolving solvent due to volatilization, and the corrosion of the power source 60 attributable to the vaporized drug due to the volatilization, are thus prevented.
Also as shown in
In the packaged iontophoresis system 15 of
In this way, the cutting guide 400 guides the cutting line so that the part welded to the connection part 70 remains at the connection part 70. Therefore, the package material 80 can be opened and removed without peeling off the connection-part welded surface 94. As a result, the package material 80 is opened and removed without damaging the active conductive wire 205 and the counter conductive wire 305 of the connection part 70. The welding strength for the connection-part welded surface 94 may be stronger than the welding strength for the welded surface 90. In this case, the connection-part welded surface 94 will be more difficult to peel off when opening and removing the package material 80, to further facilitate opening and removal of the package material 80 without damaging the active conductive wire 205 and the counter conductive wire 305 of the connection part 70.
As shown in
To use the packaged iontophoresis system 25 of
To use the packaged iontophoresis system 35
The tape 450 (460) of the packaged iontophoresis system 35 in
The first electrolyte retainer 220 is electrically connected to the first electrode member 210, and retains an electrolyte. A compound having an oxidation reduction potential lower than that of water when compared to electrolysis reaction of water (i.e. oxidation and reduction of water) and that is easily oxidized and reduced is dissolved in the electrolyte. The ion exchange membrane 230 of the second conductivity type sandwiches the first electrolyte retainer 220 with the first electrode member 210, and selectively permeates ions of the second conductivity type. The drug solution retainer 240 retains drug solutions containing drug ions. Drug ions are either anions or cations resulting from ionic dissociation of drugs, and are ions of the first conductivity type having drug efficacy. The ion exchange membrane 250 of the first conductivity type sandwiches the drug solution retainer 240 with the ion exchange membrane 230 of the second conductivity type, and selectively permeates ions of the first conductivity type.
As shown in
The second electrolyte retainer 320 is electrically connected to the second electrode member 310, and retains an electrolyte. The ion exchange membrane 330 of the first conductivity type sandwiches the second electrolyte retainer 320 with the second electrode member 310, and selectively permeates ions of the first conductivity type. The third electrolyte retainer 340 is arranged in the opposite side of the second electrolyte retainer 320 against the ion exchange membrane 330 of the first conductivity type, and retains an electrolyte. The ion exchange membrane 350 of the second conductivity type sandwiches the third electrolyte retainer 340 with the ion exchange membrane 330 of the first conductivity type, and selectively permeates ions of the second conductivity type. Note that a compound having an oxidation reduction potential lower than the oxidation reduction potential of water when compared to an electrolysis reaction of water (i.e. oxidation and reduction of water) and that is easily oxidized and reduced is dissolved in the electrolyte retained by the second electrolyte retainer 320 and in the third electrolyte retainer 340, similar to the electrolyte retained by the first electrolyte retainer 220 of the operation electrode structure 200.
The container 260 of the operation electrode structure 200 and the container 360 of the non-operation electrode structure 300 include, at the contact surface thereof, an active adhesive surface 262 and a counter adhesive surface 362 having adherence property respectively. The active adhesive surface 262 and the counter adhesive surface 362 are shown in
When power is supplied, i.e. when voltage is applied, to the first electrode member 210 and the second electrode member 310 from the power source 60 while the operation electrode structure 200 and the non-operation electrode structure 300 of the iontophoresis system 10 are in contact with the skin, electric current runs between the first electrode member 210 and the second electrode member 310 with the skin therebetween, effecting iontophoresis.
Here, the concrete configuration of the iontophoresis system 10 is detailed by taking an example where the drug ions are anions. In this example, the first conductivity type is negative, and the second conductivity type is positive. Therefore, the first electrode member 210 of the operation electrode structure 200 is a cathode, and the second electrode member 310 of the non-operation electrode structure 300 is an anode. In addition, in the operation electrode structure 200, the ion exchange membrane 230 of the second conductivity type is a cation exchange membrane, and the ion exchange membrane 250 of the first conductivity type is an anion exchange membrane. Further, in the operation electrode structure 200, the ion exchange membrane 330 of the first conductivity type is an anion exchange membrane, and the ion exchange membrane 350 of the second conductivity type is a cation exchange membrane.
The iontophoresis system 10, during usage, has the following advantages. In the operation electrode structure 200, the drug ions included in the drug solution retained by the drug solution retainer 240 moves to the opposite side (to the side of the skin) of the first electrode member 210 being the cathode, by means of the electrophoresis. Then the drug ions are permeated to the skin from the drug solution retainer 240 through the ion exchange membrane 250 of the first conductivity type contacting the skin. On the other hand, cations in the living body are not permeated through the ion exchange membrane 250 of the first conductivity type, and do not move toward the drug solution retainer 240. Therefore, the drug ions are able to be introduced to a living body by iontophoresis in a stable use state. Cations in the drug solution retainer 240 pairing with the drug ions (anion) move toward the first electrode member 210, are permeated through the ion exchange membrane 230 of the second conductivity type being a cation exchange membrane, and move towards the first electrolyte retainer 220. Consequently, ionic balance is maintained in the drug solution retainer 240 in the use state, and so the pH change hardly occurs. As a result, the energizing resistance does not substantially increase, restraining reductions in transportation efficiency of the drug ions.
On the other hand, in the non-operation electrode structure 300, a compound dissolved in the electrolyte retained by the third electrolyte retainer 340 has an oxidation reduction potential lower than that of water. Therefore, electrolysis of water in the second electrode member 310 acting as an anode does not occur. Consequently, an increase of energizing resistance is prevented because of prevention of the contact between the second electrode member 310 and the electrolyte retained in the third electrolyte retainer 340 by air bubbles (oxygen gas) generated due to electrolysis.
Note that when the drug ions are cations, the first conductivity type is positive, and the second conductivity type is negative. Therefore, the electric polarity of the first electrode member 210 and the second electrode member 310 are reversed in the iontophoresis system 10 shown in
In the present embodiment, an exemplary drug ions provided for use with application of iontophoresis is as follows. An exemplary positively charged drug ions includes anesthetic (e.g. procaine hydrochloride and lidocaine hydrochloride), a therapeutic agent for gastrointestinal disease (e.g. carnitine chloride), a muscle relaxant suxametonium (e.g. pancronium bromide), and antibiotics (e.g. tetracyclines drug product, kanamycins drug product, and gentamicins drug product). An exemplary negatively charged drug ions includes a vitamin (hereinafter abbreviated as “V”) preparation (e.g. VB2, VB12, VC, VE, and folate), adrenal cortex hormone (e.g. water-soluble hydrocortisone drug product, water-soluble dexamethasone drug product, and water-soluble prednisolone drug product), and antibiotics (e.g. water-soluble penicillin drug product, and water-soluble chloramphenicol drug product).
Exemplary voltage used in application of iontophoresis is a pulse voltage for use as a low-frequency therapy equipment. The voltage may be gradually raised or lowered. The electric current running in a body is increased or decreased as necessary depending on the area of the first electrode member 210 and the second electrode member 310, the part of the body being the dosing target, or the individual difference of a person being the dosing target, so that the person would not suffer from pain or heat.
The power source 60 may constantly apply the voltage for applying the iontophoresis, to the first electrode member 210 and the second electrode member 310. However, there may be further provided means for detecting contact between the apparatus body 50 and the skin, to apply a voltage for applying the iontophoresis only when the apparatus body 50 is brought in contact with the skin. The power source 60 may be desorbable with respect to the connection part 70, or be integrally formed with the connection part 70. Concrete appropriate examples of the power source 60 include a battery, a constant-voltage device, a constant-current device, a constant-voltage/constant-current device (Galvanic device). It is desirable that the power source 60 has a favorable portability.
The electrode material of the first electrode member 210 and of the second electrode member 310 may be selected as necessary depending on the characteristics of the drug ions, and may be a conductive material such as carbon and platinum.
The first electrolyte retainer 220 of the operation electrode structure 200 and the second electrolyte retainer 320 and the third electrolyte retainer 340 of the non-operation electrode structure 300 preferably retain an electrolyte that is a solution in which a compound having an oxidation reduction potential lower than that of water compared to an electrolysis reaction of water (i.e. oxidation and reduction of water), and that is easily oxidized and reduced, is dissolved. For example, a mixed aqueous solution of first copperas (FeSO4) and second copperas (Fe2(SO4)3), an aqueous solution of sodium ascorbate, and a mixture aqueous solution of lactic acid and sodium fumarate. Furthermore, the retaining form of these electrolytes may be a gel, a desirable medium (gauze or water-absorbing polymer material) into which the electrolyte is impregnated, or a solution that retains the electrolyte as is.
For example, the anion exchange membrane may be a polymer having a quaternized ammonium group at the side chain thereof, and the cation exchange membrane may be a polymer having a sulfonate group at the side chain thereof. They may be selected desirable, and also be combined as appropriated depending on the type of the drug ions used.
It is preferable that the container 260 and the container 360 are made of a material that is an electric insulator and resistant to ionic conductivity, and has plasticity, bendability, or flexibility, and has a form-maintaining nature. Exemplary materials include acrylic, polyvinyl chloride, polyacrylic, polyamide, polysulphone, polystyrene, polyoxymethylene, polycarbonate, polyester, and copolymers thereof.
As stated above, with the present embodiment the package material 80 may be opened without peeling off the connection-part welded surface 94. Therefore, opening and removal of the package material 80 does not damage the active conductor 205 or the counter conductor 305 of the connection part 70.
Although some aspects of the present invention have been described by way of exemplary embodiments, the scope of the present invention is not limited thereto, and it should be understood that those skilled in the art might make many changes and substitutions without departing from the spirit and the scope of the present invention which is defined only by the appended claims.
As clear from the foregoing, according to one embodiment of the present invention, the decrease in ionic drugs or drug-dissolving solvent due to volatilization, and the corrosion of the power source attributable to the vaporized drug due to the volatilization are thus prevented.
Number | Date | Country | Kind |
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2005-356431 | Dec 2005 | JP | national |
This is a continuation application of PCT/JP2006/324182 filed on Dec. 4, 2006 which claims priority from a Japanese Patent Application No. 2005-356431 filed on Dec. 9, 2005, the contents of which are incorporated herein by reference.
Number | Date | Country | |
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Parent | PCT/JP2006/324182 | Dec 2006 | US |
Child | 12135901 | US |