User activated iontophoertic device

• US 5,817,044 A
• Filed: 07/28/1994
• Issued: 10/06/1998
• Est. Priority Date: 11/05/1992
• Status: Expired due to Term

• Current Assignee: Vyteris, Inc.
• Original Assignee: Becton, Dickinson & Co
• Inventors: Hoke, Randal A., Broberg, Bernt Fredrick Julius, Evers, Hans Christer Arvid, DeNuzzio, John D.
• Primary Examiner(s): Prebilic, Paul B.
• Application Number:
  US08/282,100
• Time in Patent Office: 1,531 Days
• Field of Search: 604/20, 604/306, 604/307, 607/153
• US Class Current: 604/20
• CPC Class Codes: A61N 1/0448 Drug reservoir

Abstract

A user activated iontophoretic device of the present invention includes an electrode assembly, an electrode reservoir and at least one drug reservoir. The device is divided or otherwise separated into at least two portions, with one portion containing the electrode reservoir and the other containing the drug reservoir, which may include a medication in a dry form. In one embodiment, the two portions are each contained in separate compartments of a pouch. In another embodiment, the portions are contained in a single compartment and divided by a barrier. A method of activating the device includes causing the two portions to come into electrical conducting contact with one another to at least partially hydrate one of the reservoirs. This can be accomplished, for example, by either folding the device to bring the two portions into contact with one another or simply by removing the barrier dividing the two portions. In the alternative, the device may include two separate portions which can be brought together to activate the device. In this way, the device is suitable for use to deliver a high dose efficiency, while providing a commercially suitable shelf-life.

Claims

1. A user activated device for iontophoretically delivering at least one medication to an applied area of a patient, comprising:

an electrode assembly means for driving a medication into the applied area of the patient;

wherein the electrode assembly means is situated in electrical communication with a first reservoir, having an electrolyte;

a second reservoir containing a substantially non-hydrated medication to be delivered to the applied area of the patient;

a first holding means for holding the electrode assembly means and the first reservoir, said first holding means including a means for maintaining the electrode assembly means in electrical communication with the first reservoir;

a second holding means for holding the second reservoir and including a means for maintaining the second reservoir separate in relation to the first reservoir;

the first holding means and the second holding means each having a release liner or barrier for sealing the first holding means and the second holding means so that prior to activation the second reservoir containing the medication is isolated from the first reservoir and maintained in a non-hydrated condition to prevent degradation and dilution of the medication contained in the second reservoir;

wherein the device is activated by removing the release liner or barrier and placing the first reservoir in contact with the second reservoir, thereby to at least partially hydrate the medication contained in the second reservoir and to bring the first reservoir and the second reservoir into electrical communication with one another.

2. The user activated device of claim 1, wherein the electrolyte is an electrically conductive gel.

3. The user activated device of claim 2, wherein said first holding means and said second holding means are hingedly connected together along a bendable member so that the device may be activated by folding the holding means along the bendable member to bring the first reservoir and the second reservoir into electrical communication.

4. The user activated device of claim 3, wherein said barrier means is adapted to include a pull tab extending from the holding means so that the device may be activated by pulling the tab to remove the barrier from the device to bring the first reservoir and the second reservoir into electrical communication.

5. The user activated device of claim 3, wherein said first reservoir includes a second medication to be delivered to the applied area of the patient.

6. The user activated device of claim 3, further comprising at least one barrier situated between the first reservoir and the second reservoir to limit the presence of competing ions when the two reservoirs are in electrical communication.

7. The user-activated device of claim 3, further comprising a flexible member which extends from the first holding means or the second holding means, said flexible member having a third reservoir attached thereto, said third reservoir containing a substantially non-hydrated second medication to be delivered to the applied area of the patient;

the third reservoir having a release liner or barrier for sealing the third reservoir so that prior to activation, the third reservoir is isolated from the first reservoir and maintained in a non-hydrated condition to prevent degradation and dilution of the medication contained in the third reservoir;

the third reservoir may be activated by removing the release liner or barrier and folding the flexible member so that the third reservoir is at least partially hydrated and placed in electrical communication with second reservoir after the second reservoir has been placed in electrical communication with the first reservoir.

8. A user activated device for iontophoretically delivering at least two medications through an applied area of a patient, comprising:

an electrode assembly means for driving a medication into the applied area of the patient to be absorbed by the body of the patient;

wherein the electrode assembly means is situated in electrical communication with a first reservoir, which contains a substantially hydrated electrolyte and an active compound to be delivered to the applied area of the patient;

a second reservoir containing a substantially non-hydrated vasoactive agent medication to be delivered to the applied area of the patient;

a first holding means for holding the electrode assembly means and the first reservoir, said first holding means including a means for maintaining the electrode assembly means in electrical communication with the first reservoir;

a second holding means for holding the second reservoir and including a means for maintaining the second reservoir separate in relation to the first reservoir;

the first holding means and the second holding means each having a release liner or barrier for sealing the first holding means and the second holding means so that prior to activation the second reservoir containing the medication is isolated from the first reservoir and maintained in a non-hydrated condition to prevent degradation and dilution of the medication contained in the second reservoir;

wherein the device is activated by removing the release liner and placing the first reservoir in contact with the second reservoir, thereby to at least partially hydrate the vaso active agent contained in the second reservoir and to bring the first reservoir and the second reservoir into electrical communication with one another.

9. The user activated device of claim 8, wherein the electrolyte is an electrically conductive gel.

10. The user activated device of claim 9, wherein the active compound is a local anesthetic and the vasoactive agent is a vaso-constricting compound.

11. The user activated device of claim 10, wherein the local anesthetic is lidocaine and the vaso-constricting compound is adrenaline.