Iontophoretic electrode device, method and gel insert

• US 4,383,529 A
• Filed: 11/03/1980
• Issued: 05/17/1983
• Est. Priority Date: 11/03/1980
• Status: Expired due to Term

• Current Assignee: Wesco Incorporated (HF HOLDINGS INC)
• Original Assignee: Wesco Incorporated (HF HOLDINGS INC)
• Inventors: Webster, Henry L.
• Primary Examiner(s): Cohen, Lee S.
• Application Number:
  US06/202,889
• Time in Patent Office: 925 Days
• Field of Search: 128/207.21, 128/639-641, 128/644, 128/783, 128/798, 128/802, 128/803, 128/156, 128/268
• US Class Current: 604/20
• CPC Class Codes: A61N 1/044 Shape of the electrode

Abstract

An iontophoretic electrode device, method, and hydrophilic, hydrated gel insert for the electrode device all involve a preformed, shape-retaining, gel body preferably of disc formation having mutually opposite, parallel faces. An agar gel disc having an ionic drug diffused throughout is the preferred, iontophoretic gel body that is packaged and sold as such for insertion in a cup-like receptacle and securement to an electrode plate within the receptacle, so as to protrude free and clear therefrom for pressing against the skin of a medical patient.

Claims

1. An iontophoretic electrode device, comprising an electrode adapted for electrical connection to a voltage source;

and a preformed, shape and fluid retaining, semisolid body of a hydrophilic, hydrated gel throughout which is diffused an ionic drug for administration to a patient through intact skin by iontophoresis, said body being secured to the electrode in good electrical contact therewith and having a free and unconfined, solid gel contact face so disposed as to make good electrical contact with the skin of a patent when the electrode device is applied to the patient.

2. An electrode device according to claim 1, wherein the gel is an agar gel.

3. An electrode device according to claim 4, wherein the agar gel has an agar concentration of no less than about 3% (w/v) or greater.

4. An electrode according to claim 5, wherein the agar concentration is about 4% (w/v).

5. An electrode device according to claim 1, wherein the gel body is conductively secured to the electrode by means of a thin layer of a viscous, electrically conductive material.

6. An electrode device according to claim 1, wherein the gel body is a flat disc having mutually opposite, parallel faces.

7. A method of transporting ionic drug molecules through the skin of a medical patient by means of iontophoresis, comprising pressing against an area of skin through which the drug is to be transported a free and unconfined, solid gel contact face of a shape and fluid retaining, semi-solid, hydrophilic, hydrated gel body which has the ionic drug molecules diffused throughout and which is secured in good electrical contact to an electrode, so said body can serve as an iontophoretic electrode;

applying a second iontophoretic electrode to the patient; and

electrically energizing said electrodes by electrical power of respectively different polarities to effect the desired transporting of said ionic drug molecules through said area of the skin.

8. For use as a drug-administering insert in an iontophoretic electrode device, a performed, shape and fluid retaining, semi-solid body of a hydrophilic, hydrated gel having an ionic drug diffused throughout and having a free and unconfined, solid gel contact face.

9. A drug-administering insert according to claim 8, wherein the body is of flat disc formation having mutually opposite, parallel faces.

10. A semi-solid gel body in accordance with claim 8, wherein the gel is an aqueous agar gel having an agar concentration of about 4% w/v.

11. A substantially solid gel body in accordance with claim 10, wherein the ionic drug is pilocarpine for iontophoretic use in the stimulation of human sweat glands for the determination of cystic fibrosis.

12. An iontophoretic electrode device for administering an ionic drug by iontophoresis to a medical patient, comprising a rigid, cup-like receptacle of electrically non-conductive material having a rimmed opening for the reception of a substantially conforming, preformed, shape and fluid retaining, semi-solid body of a hydrophilic, hydrated gel containing the ionic drug to be administered;

an electrode plate spaced inwardly of said receptacle from said rimmed opening; and

an electrical conductor adapted for connection with a source of electrical power and extending into electrical connection with said electrode plate;

a preformed, shape and fluid retaining, semi-solid body of drug-containing, hydrophilic, hydrated gel substantially conforming to and secured within said opening by adherence to said electrode plate, the thickness of said semi-solid body being such as to protrude slightly from said receptacle beyond said rimmed opening so as to present a free and unconfined, solid gel face of said body for contact with the skin of a medical patient, whereby, under iontophoresis, the drug will pass into the body of the patient without leaving foreign matter on the skin so contacted; and

securement means for holding the receptacle on the body of the patient with said solid gel face in contact with the patient'"'"'s skin.

13. An iontophoretic electrode device in accordance with claim 12, wherein the electrode plate is spaced from the bottom of the receptacle to provide a space within which the electrical conductor extends and connects to said electrode plate.

14. An iontophoretic electrode device in accordance with claim 13, wherein a non-conductive pin has end portions tightly fitted into respective receiving openings in the bottom of the receptacle and in the electrode plate, respectively, the end portion of the pin received by the bottom of the receptacle projecting outwardly from said bottom to provide the securement means whereby the receptacle can be held on the body of the patient.

15. An iontophoretic electrode device in accordance with claim 12, wherein the drug to be administered is pilocarpine for inducing sweating at the area of skin contacted by the gel.

16. An electrode device according to claim 12, wherein the gel body is conductively secured to the electrode plate by means of a thin layer of a viscous, electrically conductive material.