Methods for electrokinetic delivery of medicaments

• US 6,385,487 B1
• Filed: 12/04/1998
• Issued: 05/07/2002
• Est. Priority Date: 05/08/1996
• 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:
  US09/205,751
• Time in Patent Office: 1,250 Days
• Field of Search: 604/19, 604/20, 604/289, 604/500, 604/501, 607/97, 607/115, 607/120, 607/149, 607/152, 601/1, 128/798, 128/799, 128/803
• 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

Drugs and a portable iontophoresis apparatus for facilitating delivery of the drugs across the cutaneous membrane into adjacent underlying tissues and blood vessels. The apparatus employs a modular, detachable non-reusable medicament-containing applicator electrode which is adapted to attach to a base assembly. The apparatus is designed to be hand-held and includes a circumferential tactile electrode band on the base assembly which provides electrical connection between the skin of the user'"'"'s hand and one pole of a bipolar power source housed within the base assembly. The opposing pole of the power source is connected to the applicator electrode. When the applicator is placed against the skin of a user, the user'"'"'s body completes the electrical circuit between the applicator and tactile electrodes. The apparatus employs a disposable applicator electrode which accepts a variety of antimicrobial and anesthetic agents for transdermal iontophoretic or ionosonic delivery. A method for using the device for the treatment of Herpes simplex infection and related viral infections which produce similar cutaneous lesions is presented. The apparatus, when used in accordance with the antiviral medicaments and method described herein, demonstrated >90% treatment efficacy in clinical trials.

Claims

1. A method of treating a lesion comprising the steps of:

(a) presenting a hand-held device for manual self administration of medicament to the lesion, said device including a portion thereof shaped for grasping by an individual'"'"'s hand, a self-contained power source, an applicator electrode having a substrate containing medicament and electrically coupled with said power source, and a tactile electrode formed of electrically conductive material electrically coupled to said power source and exposed on said shaped portion of said device;

(b) grasping said shaped portion of said device, including contacting the tactile electrode with the individual'"'"'s hand;

(c) bringing the substrate containing the medicament into contact with said lesion by manual manipulation of the hand-held device by the individual, thereby completing an electrical circuit, including the power source, tactile and applicator electrodes and the individual for electrokinetic delivery of the medicament of the substrate into the lesion; and

(d) inducing ultrasonic vibration in a tissue comprising the lesion by actuating a vibratory element carried by said device and electrically coupled to said power source.

2. The method of claim 1 wherein said medicament comprises (2amino-1,9-dihydro-9-[(2hydroxyethoxy) methyl]-6H-purin-6-one) or ionosonically transportable analogs therof.

3. A method according to claim 1 including simultaneously vibrating the tissue comprising the lesion while electrokinetically delivering the medicament of the substrate into the lesion.

4. A method of treating a lesion associated with acne comprising the steps of:

(a) presenting a hand-held device for manual self-administration of a medicament to the lesion, said device including a portion thereof shaped for grasping by an individual'"'"'s hand, a self-contained power source, an applicator electrode having a substrate containing the medicament and electrically coupled with said power source and a tactile electrode formed of electrically conductive material electrically coupled to said power source and exposed on said shaped portion of said device;

(b) grasping said shaped portion of said device including contacting the tactile electrode with the individual'"'"'s hand;

(c) bringing the substrate containing the medicament into contact with said lesion by manual manipulation of the hand-held device by the individual thereby completing an electrical circuit, including the power source, tactile and applicator electrodes and the individual for electrokinetic delivery of the medicament of the substrate into the lesion; and

(d) inducing ultrasonic vibration in a tissue comprising the lesion by actuating a vibratory element carried by said device and electrically coupled to said power source.

5. A method according to claim 4 including simultaneously vibrating the tissue comprising the lesion while electrokinetically delivering the medicament of the substrate into the lesion.

6. A method according to claim 4 wherein the medicament comprises an ionic compound and said compound is anionic.

7. A method according to claim 4 wherein the medicament comprises an ionic compound and said compound is cationic.

8. A method according to claim 4 wherein the medicament comprises an ionic compound, said compound being a hydroxyl ion.

9. A method of treating a lesion comprising the steps of:

(a) presenting a hand-held device for manual self-administration of a medicament to the lesion, said device including a self-contained power source, an applicator electrode having a substrate containing the medicament and electrically coupled with said power source, and a ground electrode formed of electrically-conductive material electrically coupled to said power source and exposed for contact with an individual'"'"'s skin;

(b) bringing the substrate containing the medicament into contact with said lesion by manual manipulation of the hand-held device by the individual and the ground electrode into contact with an individual'"'"'s skin, thereby completing an electrical circuit, including the power source, ground and applicator electrodes and the individual for electrokinetic delivery of the medicament of the substrate into the lesion; and

(c) inducing ultrasonic vibration in a tissue comprising the lesion by actuating a vibratory element carried by said device and electrically coupled to said power source.

10. A method according to claim 9 including simultaneously vibrating the tissue comprising the lesion while electrokinetically delivering the medicament of the substrate into the lesion.

11. A method of treating a lesion associated with acne comprising the steps of:

(a) presenting a hand-held device for manual self-administration of a medicament to the lesion, said device including a portion thereof shaped for grasping by an individual'"'"'s hand, a self-contained power source, an applicator electrode having a substrate containing the medicament and electrically coupled with said power source and a ground electrode formed of electrically conductive material electrically coupled to said power source and exposed for contact with a individuals skin;

(b) bringing the substrate containing the medicament into contact with said, lesion by manual manipulation of the hand-held device by the individual and the ground electrode into contact with an individual'"'"'s skin, thereby completing an electrical circuit, including the power source, ground and applicator electrodes and the individual for electrokinetic delivery of the medicament of the substrate into the lesion; and

(c) inducing ultrasonic vibration in a tissue comprising the lesion by actuating a vibratory element carried by said device and electrically coupled to said power source.

12. A method according to claim 11 including simultaneously vibrating the tissue comprising the lesion while electrokinetically delivering the medicament of the substrate into the lesion.