Transdermal drug applicator and electrodes therefor

• US 5,605,536 A
• Filed: 10/14/1993
• Issued: 02/25/1997
• 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): Green, Randall L.
• Assistant Examiner(s): Bockelman, Mark
• Application Number:
  US08/136,726
• Time in Patent Office: 1,230 Days
• Field of Search: 604/20, 607/152, 607/153, 607/149
• 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. An electrically powered transdermal drug applicator having at least one medicament for application to a living body for the migration of the at least one medicament through the skin into the blood stream comprising essentially of the following elements:

Three generally flat electrode elements, free of a flexible, non-conductive substrate having conductive coated areas and free of any folds, and forming a transdermal drug applicator with multiple electrode elements, and with one electrode element thereof being separated from the other two which are juxtaposed to each other, and with two of said three electrode elements being either an active medicament containing electrode element or an inactive electrode element having no medicament,

reservoir means having a predetermined depth and a plurality of sides forming a periphery, in each of said electrode elements of said transdermal drug applicator, with at least one of said juxtaposed electrode elements including said reservoir means containing said at least one medicament; and

said reservoir means being free of transversing elements passing through at least a portion of said electrode elements and/or said reservoir means;

each of said electrode elements, including said at least one having said at least one medicament in said reservoir means having an impermeable tacky, non-conducting and insulating barrier seal coextensive with the sides of said electrode elements and said reservoir means and extending along at least the full depth of said electrode elements and said reservoir means, so as to form an effective dam between said juxtaposed electrode elements and said reservoir means, with an end lip-like curtain about all sides forming said periphery of said electrode elements and said reservoir means;

the dam-like barrier seal maintaining electrode and reservoir separation of said juxtaposed electrode and reservoir elements from each other and forming a tacky peripheral lip seal against the skin for precluding electrical shorting across said electrode-reservoir elements;

an electrical circuit, including a power source and current control device, for supplying electrical power in parallel to all of said electrode elements and said reservoir means and forming a closed electrical loop circuit from said power source connected via conductors to said electrode elements and said reservoir means, and the skin when the transdermal drug applicator is applied thereto;

a relatively, thin non-conductive cover means partially enclosing and conforming to said electrode elements and said reservoir means so as to envelope at least said electrode elements and said reservoir means and at least portions of said electrical circuit and leaving sides of said electrode elements and said reservoir means exposed for contact with the skin, and

adhesive means for affixing said transdermal drug applicator to said skin, whereby said electrical circuit through the skin is formed when said transdermal drug applicator is adhesively affixed to said skin, thereby creating at least one physico/chemical mass transfer phenomenon which causes said at least one medicament to migrate from said reservoir means containing said at least one medicament through the skin and into the blood stream of said living body.

2. A transdermal drug applicator according to claim 1, wherein at least one of said electrode elements constitutes an inactive or indifferent electrode.

3. A transdermal drug applicator according to claim 1, wherein all of said electrode elements are active electrodes.

4. A transdermal drug applicator according to claim 1, wherein said reservoir means contain different drugs.

5. The transdermal drug applicator according to claim 1, wherein at least one electrode element is separated from said other electrode elements by a gap.

6. The transdermal drug applicator according to claim 5, wherein said gap is an air gap.

7. The transdermal drug applicator according to claim 1, wherein said barrier seal dam is made of an impervious, non-conducting material.

8. The transdermal drug applicator according to claim 7, wherein said impervious, non-conducting material is silicone.

9. A transdermal drug applicator according to claim 1, wherein each said electrode element comprises a conductive element adjacent its respective reservoir means;

and said electrical circuit being connected to said conductive elements for driving each reservoir means so as to enable said at least one physico/chemical mass transfer phenomenon to take place at the surface of said skin.

10. An electrically powered transdermal drug applicator having at least one medicament for application to a living body for the migration of the at least one medicament through the skin into the blood stream comprising:

Three generally flat electrode elements, free of a flexible, non-conductive substrate having conductive coated areas and free of any folds, and forming a transdermal drug applicator with multiple electrode elements, and with one electrode element thereof being separated from the other two which are juxtaposed to each other, and with two of said three electrode elements being either an active medicament containing electrode element or an inactive electrode element having no medicament,

reservoir means having a predetermined depth and a plurality of sides forming a periphery, in each of said electrode elements of said transdermal drug applicator, with at least one of said juxtaposed electrode elements including said reservoir means containing said at least one medicament; and

said reservoir means being free of transversing elements passing through at least a portion of said electrode elements and/or said reservoir means;

each of said electrode elements, including said at least one having said at least one medicament in said reservoir means having an impermeable tacky, non-conducting and insulating barrier seal coextensive with the sides of said electrode elements and said reservoir means and extending along at least the full depth of said electrode elements and said reservoir means, so as to form an effective dam between said juxtaposed electrode elements and said reservoir means, with an end lip-like curtain about all sides forming said periphery of said electrode elements and said reservoir means;

the dam-like barrier seal maintaining electrode and reservoir separation of said juxtaposed electrode and reservoir elements from said other and forming a tacky peripheral lip seal against the skin for precluding electrical shorting across said electrode-reservoir elements;

an electrical circuit, including a power source and current control device, for supplying electrical power in parallel to all of said electrode elements and said reservoir means and forming a closed electrical loop circuit from said power source connected via conductors to said electrode elements and said reservoir means, and the skin when the transdermal drug applicator is applied thereto;

a relatively thin non-conductive cover means partially enclosing and conforming to said electrode elemnts and said reservoir means so as to envelope at least said electrode elements and said reservoir means and at least portions of said electrical circuit and leaving sides of said electrode elements and said reservoir means exposed for contact with the skin, and

adhesive means for affixing said transdermal drug applicator to said skin, whereby said electrical circuit through the skin is formed when said transdermal drug applicator is adhesively affixed to said skin, therby creating at least one physico/chemical mass transfer phenomenon which causes said at least one medicament to migrate from said reservoir means containing said at least one medicament through the skin and into the blood stream of said living body; and

wherein said at least one electrode element including said reservoir means containing said at least one medicament including high and low drug concentration zones separated by a membrane forming a drug gradient across said reservoir means.

11. A transdermal drug applicator according to claim 10, wherein said electrode elements are generally of the same construction.

12. A transdermal drug applicator according to claim 10, wherein said electrode elements are of different constructions.

13. A transdermal drug applicator according to claim 10, wherein said electrode elements are of different size.

14. The transdermal drug applicator according to claim 10, wherein said membrane is a semi-permeable member for maintaining a predetermined drug gradient concentration and desired pH of said reservoir means, whereby optimum administration of the delivery of said at least one medicament is achieved.