Disposable and/or replenishable transdermal drug applicators and method of manufacturing same

• US 5,653,682 A
• Filed: 10/24/1994
• Issued: 08/05/1997
• Est. Priority Date: 08/18/1983
• Status: Expired due to Term

• Current Assignee: Drug Delivery Systems Incorporated
• Original Assignee: Drug Delivery Systems Incorporated
• Inventors: Sibalis, Dan
• Primary Examiner(s): Bockelman, Mark
• Application Number:
  US08/327,624
• Time in Patent Office: 1,016 Days
• Field of Search: 604/20-21, 604/890.1, 604/290, 607/129, 607/149-152, D24/189
• US Class Current: 604/20
• CPC Class Codes: A61M 31/002 Devices for releasing a drug at a continuous and controlled rate for a prolonged period of time artificial gland structures or devices A61F2/022; intra-uterine contraceptive devices A61F6/14; tampons for introducing into the vagina A61F13/20, A61L15/00; suppositories or bougies for intra-vaginal or intra-uterine application A61K9/02; physical forms of medicinal preparations for sustained or differential drug release A61K9/20, A61K9/50
• CPC Class Codes: A61M 37/00 Other apparatus for introducing media into the body for reproduction or fertilisation A61B17/425; apparatus for iontophoresis or cataphoresis A61N1/30; Percutany, i.e. introducing medicines into the body by diffusion through the skin salt baths A61H33/04
• CPC Class Codes: A61N 1/0436 Material of the electrode
• CPC Class Codes: A61N 1/044 Shape of the electrode
• CPC Class Codes: A61N 1/0448 Drug reservoir
• 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
• CPC Class Codes: Y10T 29/49117 Conductor or circuit manufacturing
• CPC Class Codes: Y10T 29/4921 with bonding

Abstract

An electrically/battery powered transdermal drug applicator comprising a flexible non-conductive substrate with a plurality of conductive coated areas, the conductive coated areas forming drug reservoir electrodes, and a plurality of drug reservoirs separated by occlusive adhesive dams and in electrical contact with said drug reservoir electrodes. The battery is connected to the electrodes of the drug reservoirs and said applicator including electrical current conditioning means, with a conformal cover adhesively secured to said transdermal drug applicator and with a release liner covering and protecting said plurality of drug reservoirs until use.

Claims

1. A two part transdermal drug applicator for application to the skin of a patient which is electrically powered, comprising:

a flexible, non-conductive substrate member having conductive coated areas which together form a single flexible member said flexible member defining first and second surfaces, and said conductive coated areas being on said first surface and forming drug reservoir electrodes, said flexible member being folded in opposite directions at about 180 degrees at each of two opposite ends; and

further folded so as to substantially overlie atop itself forming top side and bottom side portions with the conductive coated areas providing electrical conductors between said top side and said bottom side portions, a plurality of separated drug reservoirs forming as a first part a replaceable drug reservoir assembly in electrical contact with said drug reservoir electrodes at said bottom side portions;

a reusable/replaceable second part with a power source including at least one battery having positive and negative terminals in an electrical circuit, connected to said electrical conductors at said top side portions with said power source connected to said top side portions via passage means in said flexible member for enabling electrical connections to the top side portions of both oppositely folded ends for providing current to said plurality of separated drug reservoirs via said conductors and said drug reservoir electrodes, electrical current conditioning means in said circuit with said power source and said drug reservoir electrodes, and a covering for said drug applicator enveloping and enclosing said flexible member, said power source and said current conditioning means, and said plurality of drug reservoirs leaving a side of said drug reservoirs free for application;

whereby both said first and second parts are replaceable when exhausted in use.

2. The transdermal drug applicator according to claim 1, further including a programmable control means connected to said power source for programming control of said power source for said drug applicator.

3. The transdermal drug applicator according to claim 1, wherein said drug reservoirs include gels.

4. The transdermal drug applicator according to claim 3, wherein said gels are reinforced by scrims.

5. The transdermal drug applicator according to claim 3, wherein said drug reservoirs include open cell foam material impregnated with said gels.

6. The transdermal drug applicator according to claim 5, further including a semi-permeable membrane in juxtaposition to said drug reservoirs, said semipermeable membrane having seals so as to define particular drug zones.

7. The transdermal drug applicator according to claim 6, wherein said drug zones contain drugs of different compositions from each other.

8. The transdermal drug applicator according to claim 6, wherein said drug zones contain drugs of different concentrations from each other.

9. The transdermal drug applicator according to claim 1, further including another substrate containing thereon a coated release agent, and said plurality of drug reservoirs being positioned with their free sides in juxtaposition with said release agent of said another substrate.

10. A transdermal drug applicator according to claim 9, wherein said topside portions of said coated areas are joined to said positive and negative terminals of said power source so as to create an electrical circuit when said applicator is applied to the skin.

11. A transdermal drug applicator according to claim 1, wherein some of the conductors are of a predetermined resistance so as to perform the function of a current limiting resistor.

12. The transdermal drug applicator according to claim 1, further including an adhesive layer on the other side of said non-conductive substrate for firmly securing said folded opposite ends of said non-conductive substrate to itself.

13. The transdermal drug applicator according to claim 1, further including a conductive adhesive at opposite end portions of said conductive coated areas for removably securing said plurality of drug reservoirs to said conductive coated areas.

14. The transdermal drug applicator according claim 1, wherein said electrical circuit includes indicator means in said electrical circuit for indicating the operational status of said drug applicator.

15. The transdermal drug applicator according to claim 14, wherein said indicator means is visible through aperture means provided in said covering.

16. The transdermal drug applicator according to claim 15, wherein said indicator means is electrically in series with said current conditioning means and said top side electrical conductor.

17. The transdermal drug applicator according to claim 16, wherein said indicator means is connected to said current conditioning means and said top side electrical conductor by means of conductive adhesive at joint contact points.