Device for the delivery of a substance to a subject and improved electrode assembly

• US 6,157,858 A
• Filed: 12/23/1997
• Issued: 12/05/2000
• Est. Priority Date: 12/26/1996
• Status: Expired due to Fees

• Current Assignee: Elan Pharma International Limited (Perrigo Company PLC)
• Original Assignee: Elan Pharma International Limited (Perrigo Company PLC)
• Inventors: Nitzan, Zvi, Gross, Joseph
• Primary Examiner(s): Coggins, Wynn Wood
• Assistant Examiner(s): KLINE, ERIC E
• Application Number:
  US08/997,388
• Time in Patent Office: 1,078 Days
• Field of Search: 604/20, 607/152
• US Class Current: 604/20
• CPC Class Codes: A61N 1/0436 Material of the electrode
• CPC Class Codes: A61N 1/044 Shape of the electrode
• CPC Class Codes: A61N 1/325 for iontophoresis, i.e. transfer of media in ionic state by an electromotoric force into the body electrodes for external use A61N1/0428

Abstract

The invention is directed to a device for delivering a pharmaceutically active compound or cosmetic substance to a subject comprises a flexible substrate sheet attached to an electronic controller. The controller is provided with a pair of electrical contacts on the underside thereof and is adhered to the sheet by means of a pair of strips of electrically conductive adhesive. The underside of the sheet is printed in two halves with electrically conductive ink to provide a pair of electrodes separated by an insulating barrier. A protuberance extends from each electrode and is folded onto the top of the sheet such that the contacts of the controller are adhered in electrical connection with the protuberances and thus also with the electrodes. The use of an adhesive to connect a controller in electrical communication with the electrodes enables an extremely simple construction of delivery device to be achieved.

Claims

1. A device for the delivery of a substance to a subject, comprising:

(a) control means for controlling the delivery of a substance to a subject, comprising a power source and a pair of electrically conductive contacts;

(b) a substrate having a first surface and a second surface;

(c) a pair of spaced apart electrodes fixed to the first surface of the substrate for the delivery of a substance from a supply thereof to the skin surface of a subject;

(d) a pair of electrical couples adapted to affect electrical communication between the conductive contacts of the control means and the spaced apart electrodes when each of the electrically conductive contacts of the control means and the electrodes are affixed to one another, each couple being integral with one of the electrodes and fixed to the first surface of the substrate; and

(e) adhesive on the second surface of the substrate for adhering the pair of electrically conductive contacts of the control means and the pair of electrical couples to one another, whereby when each of the electrical couples is folded away from itself, electrical communication is made between the pair of electrodes and the power source.

2. A device according to claim 1, wherein the control means comprises an electronic circuit adapted to generate an alternating voltage.

3. A device according to claim 2, wherein the voltage alternates with a period of from about 20 seconds to about 10 minutes.

4. A device according to claim 3, wherein the voltage alternates with a period of from about 1 minute to about 5 minutes.

5. A device according to claim 2, wherein the alternating voltage defines a substantially square waveform having a sawtooth component during the transition between polarities.

6. A device according to claim 1, wherein one of the electrodes is an active electrode communicating with the supply of substance and wherein the other of the electrodes is a counter electrode, the control means being connected via the adhesive to the counter electrode.

7. A device according to claim 6, wherein the control means is also connected via the adhesive to the active electrode.

8. A device according to claim 6, wherein the control means is connected to the active electrode by mechanical means.

9. A device according to claim 1, wherein the adhesive comprises an electrically conductive adhesive surface provided on at least one of the electrical couples.

10. A device according to claim 9, wherein the adhesive further comprises an electrically insulating adhesive surface provided on the electrodes or contacts.

11. A device according to claim 1, wherein the electrical contacts are folded onto a substantially circular adhesive layer disposed on the second surface of the substrate.

12. A device according to claim 11, wherein the first folded electrical contact terminates at the periphery of said circular area, and the the second folded electrical contact extends past the periphery of the circular area towards the center thereof, the second folded section being provided with an insulating section at the periphery of the circular area, whereby the two electrical contacts are provided at the periphery of the circular area and towards the center of the circular area.

13. A device according to claim 1, wherein a semi-solid or mucilaginous coating is provided on the electrode.

14. A device according to claim 13, wherein the semi-solid or mucilaginous coating is supplied separately from the electrode and is applied thereto before use.

15. A device according to claim 1, wherein the electrodes are provided with a skin contacting surface, the skin contacting surface being provided with means for retaining the device against the skin of a subject for delivery of the substance to the subject.

16. A device according to claim 1, wherein the delivery means is sufficiently flexible to conform to the skin of a subject.

17. A device according to claim 1, wherein the electrode is fixed to the first surface of the substrate by printing with conductive ink thereon.

18. A device according to claim 1, wherein the electrode is fixed to the first surface of the substrate by the vapour deposition of a metal thereon.

19. A device according to claim 1, wherein the electrical couple, when folded is adhered to the second surface of the substrate so as to maintain the electrical couple in position.

20. A device according to claim 1, wherein the control means further comprises a circular housing, and wherein one of the electrical contacts on the housing defines a peripheral region and another of the contacts defines a central region, the contacts being separated by an annular region.

21. A device according to claim 1, wherein the control means comprises an electronic control unit having at least one lead extending therefrom to a contact for attachment to the delivery means.