Iontophoretic drug delivery electrodes and method

• US 6,895,271 B2
• Filed: 08/26/2003
• Issued: 05/17/2005
• Est. Priority Date: 09/15/1998
• Status: Expired due to Fees

• Current Assignee: Nitric Biotherapeutics, Inc.
• Original Assignee: Biophoretic Therapeutic Systems, LLC
• Inventors: Henley, Julian L.
• Primary Examiner(s): KENNEDY, SHARON E
• Application Number:
  US10/647,295
• Publication Number:
  US 20040039328A1
• Time in Patent Office: 630 Days
• Field of Search: 604/20, 604/22, 604/19, 604/289, 604/500, 604/501, 601/1, 601/2, 607/115, 607/120, 607/149, 607/152, 607/98
• US Class Current: 604/20
• CPC Class Codes: A61N 1/30 Apparatus for iontophoresis, i.e. transfer of media in ionic state by an electromotoric force into the body, or cataphoresis

Abstract

Non-reusable, medicament-dispensing applicator electrodes adapted for use with an iontophoresis device for facilitating delivery of medication across the cutaneous membrane into adjacent underlying tissues and blood vessels. The embodiments of the iontophoresis electrode include an open mesh having cells in the medicament dispensing portions of the electrode which retain a medicament in the form of liquid, gel or ointment. The cells are adapted to contain and iontophoretically dispense and deliver medicament formulations, which have been previously approved for therapeutic use by cognizant regulatory authorities obviating the need for reformulation. The medicament-dispensing electrodes are composite or unitary in construction and may be useful in the treatment of acne and also genital herpes simplex infection which produces cutaneous lesions, including lesions above and below the waist. The delivery electrode, when used in accordance with the medicated electrode and method described herein, demonstrated >90% treatment efficacy in clinical trials for the treatment of genital herpes. In a particularly preferred embodiment, the dispensing electrode is adapted to be worn similarly to a glove thereby enabling the user to tactily position the medicament delivery electrode to make contact with the area to be treated; receiving current for iontophoretic transdermal delivery of medicament from a wrist-worn current driver. The electrode may also comprise a portion of one or more fingers of a glove or a whole palm to cover a larger area for self treatment. A glove having a large electrode area can be driven by a single current or a multichannel source such as described in prior patents by the present inventor.

Claims

1. A method of treatment by electrokinetic self-administration of a medicament into a treatment site for an individual, comprising:

providing a device shaped in part to conform to at least a portion of an individual'"'"'s finger and having a self-contained power source, first and second electrodes, and a substrate in electrical contact with said first electrode along a first surface of said substrate and an exposed contact surface opposite said first surface;

providing said substrate with one of an electrokinetically transportable medicament or a medicament with an electrically conductive carrier therefor;

releasably retaining the divice on the individual'"'"'s finger with the first electrode interposed between the individual'"'"'s finger portion and the substrate;

providing an electrical insulator between said first electrode and the individual'"'"'s finger portion;

while the device remains retained of the individual'"'"'s finger, placing the contact surface of said substrate into contact with the individual'"'"'s treatment site;

contacting the individual'"'"'s body with said second electrode at a location other than the treatment site; and

causing electrical current to flow through said first electrode, the medicament or conductive carrier therefor, the treatment site, the individual'"'"'s body, said second electrode and said power source to electrokinetically drive the medicament into the treatment site.

2. A method according to claim 1 including providing said device with a concave surface for contact about the individual'"'"'s finger.

3. A method according to claim 1 including providing said first electrode with a convex surface portion for contact with the first surface of said substrate, and providing said exposed contact surface of said substrate in an arcuate convex shape.

4. A method according to claim 1 wherein the step of contacting the individual'"'"'s body with said second electrode includes contacting the second electrode with the individual'"'"'s arm.