Systems and methods for electrokinetic delivery of a substance

• US 7,127,285 B2
• Filed: 02/07/2003
• Issued: 10/24/2006
• Est. Priority Date: 03/12/1999
• Status: Expired due to Fees

• Current Assignee: Nitric Biotherapeutics, Inc.
• Original Assignee: Transport Pharmaceuticals, Inc. (NB Therapeutics)
• Inventors: Goldberg, Dennis I., Henley, Julian L., Derouin, James, Potter, Joseph, Chang, Kuo Wei
• Primary Examiner(s): Bennett, Henry
• Assistant Examiner(s): NGUYEN, CAMTU TRAN
• Application Number:
  US10/359,559
• Publication Number:
  US 20030199808A1
• Time in Patent Office: 1,355 Days
• Field of Search: 604/20, 604/21, 604/501, 607/148, 607/149, 607/152, 607/153
• US Class Current: 604/20
• CPC Class Codes: A61N 1/044 Shape of the electrode
• 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
• CPC Class Codes: A61N 1/325 for iontophoresis, i.e. transfer of media in ionic state by an electromotoric force into the body electrodes for external use A61N1/0428

Abstract

A system for delivering a substance into a body at a treatment site that includes an alternating current source and a plurality of electrodes. Circuitry is connected between the alternating current source and the electrodes for supplying current to the electrodes when the electrodes are in electrical contact with said body so that a uni-directional current flow for delivering the substance into the body is maintained at the treatment site and a bi-directional current flow is maintained throughout the body. At least one of the electrodes is divided into sub-electrodes to, for example, reduce hazards associated with current concentration. These and other systems and methods are adaptable for large treatment areas and/or use a convenient and low-cost arrangement of electronics.

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 alternating current power source, a treatment electrode, an auxiliary electrode and a counter electrode;

releasably retaining the device on the individual'"'"'s finger with the counter electrode in electrical contact with the individual'"'"'s finger;

while the device remains on the individual'"'"'s finger, placing the treatment electrode in electrical contact with the individual'"'"'s treatment site with the medicament interposed between the treatment electrode and the treatment site; and

supplying current to said electrodes when said electrodes are in electrical contact with the body so that a unidirectional current flow for delivering the medicament into the body is maintained through the treatment electrode at the treatment site and a bidirectional current flow is maintained through the body.

2. A method according to claim 1 including providing the treatment electrode, the counter electrode, and the auxiliary electrode stacked relative to one another between the individual'"'"'s finger and the treatment site during treatment.

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

providing an applicator having a self-contained alternating current power source, a treatment electrode and an auxiliary electrode on one side of said applicator and a counter electrode on an opposite side thereof;

interposing the applicator between an individual'"'"'s finger with the counter electrode in electrical contact with the individual'"'"'s finger and the treatment site, the treatment electrode in electrical contact with the treatment site and with the medicament disposed between the treatment electrode and the treatment site and the auxiliary electrode in electrical contact with a portion of the individual'"'"'s body adjacent the treatment site and through at least one of the medicament or an electrical conductor; and

supplying current to said electrodes when said electrodes are in electrical contact with the body so that a unidirectional current flow for delivering the medicament into the body is maintained through the treatment electrode at the treatment site and a bidirectional current flow is maintained through the body.

4. A method according to claim 3 including providing the treatment electrode divided into sub-electrodes and providing current limiters associated with each sub-electrode.

5. A method according to claim 4 including providing the treatment electrode, the counter electrode, and the auxiliary electrode stacked relative to one another between the individual'"'"'s finger and the treatment site during treatment.

6. A method according to claim 3 including, prior to step (b), adhering the applicator to the individual'"'"'s finger.

7. A method according to claim 3 including activating the device to supply the electrical current, deactivating the device to cut off the electrical current, and reusing the device by repeating steps (b) and (c).

8. A method according to claim 7 including counting the number of treatment cycles for which the applicator has been used and permanently deactivating the applicator after the count reaches a predetermined number of treatments.

9. A method according to claim 7 including disabling the applicator for a predetermined time period to prevent reuse of the applicator for said predetermined time period after a preceding use.

10. An electrokinetic delivery system for administering a medicament to a treatment site on an individual, comprising:

an applicator having a self-contained alternating current source and a plurality of electrodes;

at least one of said electrodes being carried by said applicator adjacent one side thereof;

at least one auxiliary electrode carried by said applicator adjacent said one side and electrically separated from said one electrode;

a counter electrode adjacent a side of said electrode remote from said one side for electrical engagement with an individual'"'"'s fingertip; and

circuitry connected between the alternating current source and the electrodes for supplying current to said electrodes when said electrodes are in electrical contact with the individual'"'"'s body and with the medicament interposed between the one electrode and the body so that a unidirectional current flow for delivering the medicament into the body is maintained through the one electrode at the treatment site and a bidirectional current flow is maintained through the body.

11. A system according to claim 10 wherein said electrodes are stacked relative to one another between the individual'"'"'s fingertip and the treatment site.

12. A method according to claim 11 including providing the treatment electrode divided into sub-electrodes and providing current limiters associated with each sub-electrode.

13. A system according to claim 10 wherein said one electrode is divided into sub-electrodes and said circuitry includes current limiters respectively associated with each sub-electrode.

14. A method of treatment by electrokinetic self-administration of a substance into a treatment site of an individual, the method comprising:

(a) providing an applicator including processing circuitry, a counter electrode and a treatment electrode, wherein the treatment electrode and counter electrode are formed on opposite sides of the applicator;

a substance in contact with the treatment electrode and adapted for electrical contact with the user'"'"'s body at the treatment site; and

a conductive gel in contact with the counter electrode and adapted for electrical contact with a user'"'"'s finger;

(b) releasably retaining the applicator on the individual'"'"'s finger, with the conductive gel in electrical contact with the individual'"'"'s finger;

(c) while the applicator remains retained on the individual'"'"'s finger, placing the substance in contact with the treatment site; and

(d) causing electrical current to flow through said treatment electrode, the substance, the treatment site, the individual'"'"'s body, and said counter electrode to electrokinetically drive the substance into the treatment site.

38. A method according to claim 14 including applying steps (a)–

(d) for treating clinical conditions caused by or suspected to be caused by onychomycosis.

39. A method according to claim 14 including applying steps (a)–

(d) for treating clinical conditions caused by Herpes Simplex virus infection.

40. A method according to claim 14 including applying steps (a)–

(d) for treating clinical conditions suspected to be caused by Herpes Simplex virus infection.

41. A method according to claim 14 including applying steps (a)–

(d) for treating clinical conditions caused by acne.

42. A method according to claim 14 including applying steps (a)–

(d) for treating clinical conditions caused by human papilloma virus.

43. A method according to claim 14 including applying steps (a)–

(d) for treating skin wrinkles.

44. The method according to claim 14, wherein the system is configured as a patch.

45. The method according to claim 14, wherein the system is finger-mounted.

46. A method according to claim 14 wherein said substance includes one of ketoconazole, nystatin, griseofulin, flucytosine and metronidazole.

15. An electrokinetic method for delivering a substance into a body, the method comprising:

(a) providing a substance at a substance-delivery site on the body;

(b) placing electrodes coupled to an alternating current source in electrical contact with the body, the electrodes including a treatment electrode divided into sub-electrodes and adapted for electrical contact with the body at the substance-delivery site; and

(c) supplying current to said electrodes when said electrodes are in electrical contact with the body so that a uni-directional current flow for delivering the substance into the body is maintained through said treatment electrode at the substance-delivery site and a bi-directional current flow is maintained through the body.

16. The method according to claim 15, wherein said alternating current source has a frequency of about 100 kilohertz.

17. The method according to claim 15, wherein said alternating current source has a frequency between about 1 kilohertz and 1 megahertz.

18. The method according to claim 15, wherein the uni-directional current is generated using a diode.

19. The method according to claim 15, wherein the substance is one or more substances selected from the group consisting of:

abacavir, adefovir, amprenavir, azidothymidine, brivudin, cidofovir, delaviridine, didanosine, doxorubican, efavirenz, famciclovir, flucytosine, fluorouracil, gancyclovir, griseofulin, indinavir, ketoconazole, lamivudine, lobucavir, methotrexate, metronidazole, miconazole, n-docosanol, nelfinavir, nevirapine, nystatin, penciclovir, ribavirin, ritonavir, saquinavir, sorivudine, stavudine, tacrolimus, terbinafine HCL, trifluridine, valaciclovir, zalcitabine with or without a C21–

C28 aliphatic alcohol.

20. A method according to claim 15 including applying steps (a)–

(c) for treating clinical conditions caused by Herpes Simplex virus infection.

21. A method according to claim 15 including applying steps (a)–

(c) for treating clinical conditions suspected to be caused by Herpes Simplex virus infection.

22. A method according to claim 15 including applying steps (a)–

(c) for treating clinical conditions suspected to be caused by or caused by acne.

23. A method according to claim 15 including applying steps (a)–

(c) for treating clinical conditions caused by human papilloma virus.

24. A method according to claim 15 including applying steps (a)–

(c) for treating skin wrinkles.

37. A method according to claim 15 including applying steps (a)–

(c) for treating clinical conditions caused by or suspected to be caused by onychomycosis.

25. A system for delivering a substance into a body at a treatment site, said system comprising:

a finger applicator comprising processing circuitry including a counter electrode and a treatment electrode, wherein the treatment electrode and counter electrode are formed on opposite sides of the applicator, said processing circuitry including one of a microprocessor, a microcontroller, an ASIC or a programmable logic array;

a substance in contact with the treatment electrode and adapted for electrical contact with the user'"'"'s body at the treatment site;

a conductive gel in contact with the counter electrode and adapted for electrical contact with a user'"'"'s finger.

26. The system according to claim 25, wherein the substance is one or more substances selected from the group consisting of:

abacavir, adefovir, amprenavir, azidothymidine, brivudin, cidofovir, delaviridine, didanosine, doxorubican, efavirenz, famciclovir, flucytosine, fluorouracil, gancyclovir, griseofulin, indinavir, ketoconazole, lamivudine, lobucavir, methotrexate, metronidazole, miconazole, morphine, n-docosanol, nelfinavir, nevirapine, nystatin, penciclovir, ribavirin, ritonavir, saquinavir, sorivudine, stavudine, tacrolimus, terbinafine HCL, trifluridine, valaciclovir, zalcitabine with or without a C21–

C28 aliphatic alcohol.

27. The system according to claim 25, wherein the substance comprises estrogen or estrogen analogues.

28. The system according to claim 25, wherein the substance comprises a modulator of collagen deposition.

29. The system according to claim 25, wherein the substance comprises one or more substance selected from the group consisting of:

lidocaine, xylocaine, prontocaine, prilocaine, fetanyl, remifentanil, sufentanil, alfentanil, novocaine, procaine, morphine HCL and EMLA.

30. The system according to claim 25, wherein the substance comprises one or more substances selected from the group consisting of:

ketorolac, benzoyl peroxide, clindamycin phosphate (cleocin), erythromycin, tazarotene, adapalene, and azelaic acid.

31. The system according to claim 25, wherein the substance comprises one or more substances from the group consisting of:

imiquimod, acyclovir, sodium salicylate, salicylic acid, tretinion, benzoyl peroxide, bleomycin, interferons, and Podocon-25.

32. The system according to claim 25, wherein the processing circuitry prevents operation of the system after a predetermined number of uses of the device.

33. The system according to claim 25, wherein the processing circuitry prevents further operation of the system after a predetermined time duration corresponding to an aggregate total time usage.

34. The system according to claim 25, wherein the processing circuitry inactivates the system for a predetermined time period and reactivates the applicator after the predetermined time period.

35. The system according to claim 25, wherein the system is configured as a patch.

36. The system according to claim 25, wherein the system is finger-mounted.