Transdermal drug applicator and electrodes therefor

• US 5,651,768 A
• Filed: 12/07/1994
• Issued: 07/29/1997
• Est. Priority Date: 08/18/1983
• Status: Expired due to Fees

• Current Assignee: Drug Delivery Systems Incorporated
• Original Assignee: Drug Delivery Systems Incorporated
• Inventors: Sibalis, Dan
• Primary Examiner(s): SHAY, RANDY CITRIN
• Application Number:
  US08/350,716
• Time in Patent Office: 965 Days
• Field of Search: 604/20, 128/798, 128/799, 128/802, 128/803
• US Class Current: 604/20
• 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 1/044 Shape of the electrode
• CPC Class Codes: A61N 1/0448 Drug reservoir

Abstract

An improved transdermal drug applicator for application to a living body for the migration of at least one medicament through the skin into the blood stream embodying at least two electrode elements forming the applicator and with the electrodes separated from each other by insulating means. A reservoir means, in at least one of said electrode elements of said applicator, containing said medicament; and a circuit, including a power source, for supplying electric power to said electrodes and such reservoir means. Suitable cover means partially enclosed at least said reservoir means, and adhesive means affixes the applicator to the skin, so as to complete an electrical circuit through the skin when the applicator is affixed thereto, thus creating at least one physico/chemical mass transfer phenomenon which causes said medicament to migrate through the skin.

Claims

1. A transdermal drug applicator in the form of a conformable flexible patch for application of at least ionic or non-ionic drug medicament through the skin into the blood stream of a living patient consisting of:

a pair of electrodes comprising two reservoirs juxtaposed to each other for their full depth, and joined as a structure, with each containing a medicament therein for application into the blood stream of said patient through respective areas of the skin beneath said two reservoirs when applied thereto;

wherein full planar bottom surface areas of said reservoirs contact said skin when said applicator is in use;

means comprising an electrical circuit having a source of electrical power for supplying electrical current to said two reservoirs to effect migration of said medicament through the skin of said patient into the blood stream of said patient;

a flexible dam insulator in the form of an electrode barrier separator disposed between the two reservoirs for at least the full depth of said reservoirs, and being electrically insulative when said transdermal drug applicator is placed in use on the skin of said patient in intimate contact therewith, while isolating from each other the respective areas of the skin of said patient on which said two reservoirs are individually applied in order to effectively seal and isolate migration of medicament through said respective areas of the skin from each other, thereby precluding any electrical shorting effect due to any moisture on said skin; and

flexible cover means wrapped about except for the portions intended to be placed against respective skin areas, and for holding at least said two reservoirs as a unitary side by side structure including electrically non-conductive means for defining an electrically non-conductive peripheral edge surface about the periphery of respective peripheral areas of the two reservoirs, and said unitary side by side structure being disposed in use in intimate contact with skin of said patient with said edge surface peripherally of said respective areas of said skin with which said two reservoirs are in contact so as to also effectively seal and isolate migration of a medicament from other areas of the skin of said patient peripherally adjacent respective areas of the skin on which said two reservoirs are applied;

whereby said medicament is totally concentrated and corralled above said skin beneath said reservoirs and driven through said skin by means of an electrically induced mass transfer phenomena, and in no way forced laterally away from said respective areas of the skin when said two reservoirs are applied thereto; and

wherein at least one of said reservoirs including a pair of medicament zones having a predetermined gradient concentration for providing optimum administration of said medicament to the living patient with a controlled pH.

2. A transdermal drug applicator according to claim 1, in which said two reservoirs are made of flexible materials.

3. A transdermal drug applicator according to claim 1, in which said two reservoirs have different capacities for containing a medicament therein.

4. A transdermal drug applicator according to claim 1, in which said two reservoirs have similar configurations.

5. A transdermal drug applicator according to claim 1, in which said means comprising an electrical circuit having a source of electrical power further includes means to maintain a constant electrical current flow to effect migration of medicament at a specific rate.

6. A transdermal drug applicator according to claim 1, in which said reservoirs are deformable and deform when applied to the skin of the patient so as to conform to surfaces of the skin of said respective areas.

7. A transdermal drug applicator according to claim 1, in which medicament contained in the reservoirs are capable of said migration through the skin of said patient in response to at least one physico/chemical mass transfer phenomenon selected from the group consisting of electrophoresis, iontophoresis and electroosmosis in response to current flow through the skin from one reservoir to another reservoir.

8. A transdermal drug applicator according to claim 1, in which said flexible dam insulator and said electrically non-conductive peripheral edge surface about the periphery of respective peripheral surfaces the reservoirs are tacky to effect said intimate contact with the skin of said patient.