Indicator for electrophoretic transcutaneous drug delivery device

• US 4,622,031 A
• Filed: 10/12/1984
• Issued: 11/11/1986
• 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): Cohen, Lee S.
• Application Number:
  US06/660,192
• Time in Patent Office: 760 Days
• Field of Search: 604/20, 128/798, 128/802, 128/803, 128/82.1
• 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 1/0428 Specially adapted for iontophoresis, e.g. AC, DC or including drug reservoirs
• CPC Class Codes: A61N 1/044 Shape of the electrode
• CPC Class Codes: A61N 1/0448 Drug reservoir

Abstract

An indicator for indicating the in vivo delivery of a drug by the electrophoretic deposition of a medicament through or on a skin surface. The device includes layers forming a reservoir containing the drug, a battery layer superimposed on the reservoir, and a cover of electrically conductive material fully enclosing the layers and having a lip along its periphery to electro-conductively engage the skin surface and form an electrical circuit. An indicator, such as an LCD or an electrochemically phototropic material (ECM) is in the circuit during which closing of the circuit, the current causes delivery of the drug and activates the LCD or ECM so as to indicate delivery to the user.

Claims

1. A self-contained electrically powered drug applicator for the administration of a medicament through the skin of the blood stream of a patient comprising, reservoir means containing said medicament and forming an electrode, battery means, for charging/driving the medicament, adjacent one side of said reservoir means and being electrically connected therewith, cover means for covering comprising an electrically conductive material for partially enclosing at least said reservoir means, and being electrically connected to said battery means, the other side of said reservoir means being exposed for contacting said skin, said cover means having a lip-like electrode for making contact with said skin when mounted on said skin, and an electrically conductive adhesive material coating disposed on the underside of said lip-like electrode which is in contact with said skin, said applicator when adhered to said skin forming a complete electrical circuit through said skin, wherein with the completion of said circuit via said reservoir means, skin, lip-like electrode and battery means, said medicament migrates out of said reservoir means and through said skin into the blood stream of said patient, and indicator means in said circuit indicating delivery of said medicament to the patient.

2. The applicator according to claim 1, further comprising means in said circuit for maintaining a specific constant current flow, and wherein said medicament migrates at a specific rate of current flow, whereby the patient is provided with an indication that the medicament is being administered at said rate.

3. The applicator according to claim 1, wherein said indicator means is a light-emitting device.

4. The applicator according to claim 1, wherein said indicator means is an LCD.

5. The applicator according to claim 1 wherein said indicator means includes electrically conductive polymeric layers defining a reservoir therebetween, and a color changing material selected from the group consisting of an electrochemically phototropic material and an electrochromic material disposed in said reservoir, whereby with current flow, the color changing material undergoes a change visible to the patient.

6. The applicator according to claim 5, further comprising non-conductive spacer means in said reservoir and between said conductive polymeric layers to prevent contact of said conductive polymeric layers.

7. The applicator according to claim 6, wherein said non-conductive spacer means is a uni-layer of silica particulates.

8. The applicator according to claim 5, wherein at least one polymeric layer has a transparent portion so that the color changing material is visible to the patient.

9. The applicator according to claim 1, wherein said indicator means is an appearance change device.

10. The applicator according to claim 1, wherein said indicator means is a color change device.

11. The applicator according to claim 1, including a semi-permeable membrane on the side of said reservoir means facing said skin.

12. The applicator according to claim 1, including insulating means in said applicator for electrically insulating said electrodes from each other.