Method and system for electrokinetic delivery of a substance

• US 6,553,253 B1
• Filed: 03/10/2000
• Issued: 04/22/2003
• Est. Priority Date: 03/12/1999
• Status: Expired due to Fees

• Current Assignee: Nitric Biotherapeutics, Inc.
• Original Assignee: Biophoretic Therapeutic Systems, LLC
• Inventors: Chang, Kuo-Wei
• Primary Examiner(s): Lazarus; Ira S.
• Assistant Examiner(s): NGUYEN, CAMTU TRAN
• Application Number:
  US09/523,217
• Time in Patent Office: 1,138 Days
• Field of Search: 604/20,501,19 128/172.1,207.21,172 607/148
• US Class Current: 604/20
• CPC Class Codes: A61N 1/044 Shape of the electrode
• 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

An electrokinetic system for delivering a substance into tissue includes an alternating current source of a predetermined frequency. A first electrode is coupled to a first terminal of the alternating current source and a second electrode is coupled to a second terminal of the alternating current source. A rectifying circuit is coupled between the first electrode and the first terminal of the alternating current source. One of the first and second electrodes is adapted for electrical contact with a substance-delivery site. A current rectified by the rectifying circuit flows in a current path between the first and second electrodes when the one of the first and second electrodes is in electrical contact with the substance-delivery site to effect delivery of the substance into the tissue.

Claims

1. An electrokinetic system for delivering a substance into a body, said system comprising:

an alternating current source of a predetermined frequency;

electrodes coupled to said alternating current source, said electrodes including a treatment electrode adapted for electrically contacting a substance-delivery site on the body, a counter electrode and an auxiliary electrode; and

circuitry coupled between said electrodes and said alternating current source for supplying currents to said electrodes when said electrodes are in electrical contact with the body in order to deliver the substance into the body at the substance-delivery site.

2. The system according to claim 1, wherein the substance-delivery site is animal skin.

3. The system according to claim 2, wherein the animal skin is human skin.

4. The system according to claim 1, wherein the substance-delivery site is a cell membrane.

5. The system according to claim 1, wherein the substance-delivery site is a mucosal membrane.

6. The system according to claim 1, wherein the predetermined frequency of said alternating current source is about 100 kilohertz.

7. The system according to claim 1, wherein the predetermined frequency of said alternating current source is between about 1 kilohertz and 1 megahertz.

8. The system according to claim 1, wherein said treatment electrode electrically contacts the substance-delivery site through an electrode of a substrate carrying the substance.

9. The system according to claim 1, wherein the substance is medicament.

10. The system according to claim 1, wherein said circuitry includes a rectifying circuit for rectifying the current supplied to said treatment electrode.

11. The system according to claim 10, wherein the magnitude of the current rectified by said rectifying circuit is about 1 milliamp (RMS).

12. The system according to claim 10, wherein the magnitude of the current rectified by said rectifying circuit is between about 10 microamps (RMS) and 1 milliamp (RMS).

13. The system according to claim 10, wherein said rectifying circuit is a diode.

14. The system according to claim 1, wherein said circuitry supplies currents to said electrodes so that a uni-directional current flow for delivering the substance into the body is maintained at the substance-delivery site.

15. The system according to claim 1, wherein said circuitry supplies currents to said electrodes so that a uni-directional current flow for delivering the substance into the body is maintained at the substance-delivery site and a bi-directional current flow is maintained through the body.

16. The system according to claim 1, wherein the area of said auxiliary electrode is small compared to the area of said treatment electrode.

17. An electrokinetic system for delivering a substance into a body, said system comprising:

an alternating current source of a predetermined frequency;

first and second electrodes coupled to a first terminal of said alternating current source, and a third electrode coupled to a second terminal of said alternating current source; and

a first rectifying circuit coupled between said first electrode and the first terminal of said alternating current source and a second rectifying circuit coupled between said second electrode and the first terminal of said alternating current source,

wherein

said first electrode is adapted for electrical contact with a substance-delivery site on the body, and

when said electrodes including said first electrode are in electrical contact with said body,

a current rectified by said first rectifying circuit flows in a current path between said first and third electrodes during first cycle portions of current generated by said alternating current source so as to effect delivery of the substance into the body, and

a current rectified by said rectifying circuit flows in a current path between said second and third electrodes during second cycle portions of the current generated by said alternating current source.

18. The system according to claim 17, wherein the substance-delivery site is animal skin.

19. The system according to claim 18, wherein the animal skin is human skin.

20. The system according to claim 17, wherein the substance-delivery site is a cell membrane.

21. The system according to claim 17, wherein the substance-delivery site is a mucosal membrane.

22. The system according to claim 17, wherein the predetermined frequency of said alternating current source is about 100 kilohertz.

23. The system according to claim 17, wherein the predetermined frequency of said alternating current source is between about 1 kilohertz and 1 megahertz.

24. The system according to claim 17, wherein the magnitude of the current rectified by said first rectifying circuit is about 1 milliamp (RMS).

25. The system according to claim 17, wherein the magnitude of the current rectified by said first rectifying circuit is between about 10 microamps (RMS) and 1 milliamp (RMS).

26. The system according to claim 17, wherein the first and second rectifying circuits are diodes.

27. The system according to claim 17, wherein an area of said second electrode is less than an area of said first electrode.

28. The system according to claim 17, wherein the substance is medicament.

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

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

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

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.

30. The method according to claim 29, wherein the substance-delivery site is animal skin.

31. The method according to claim 30, wherein the animal skin is human skin.

32. The method according to claim 29, wherein the substance-delivery site is a cell membrane.

33. The method according to claim 29, wherein the substance-delivery site is a mucosal membrane.

34. The method according to claim 29, wherein said alternating current source has a frequency of about 100 kilohertz.

35. The method according to claim 29, wherein said alternating current source has a frequency between about 1 kilohertz and 1 megahertz.

36. The method according to claim 29, wherein the magnitude of the uni-directional current is about b 1 milliamp (RMS).

37. The method according to claim 29, wherein the magnitude of the uni-directional current is between about 10 microamps (RMS) and 1 milliamp (RMS).

38. The method according to claim 29, wherein the uni-directional current is generated using a diode.

39. The method according to claim 29, wherein the substance is medicament.

47. The device according to claim 36, wherein said circuitry includes a rectifying circuit for rectifying the current supplied to said treatment electrode.

48. The device according to claim 36, wherein said circuitry supplies currents to said electrodes so that a uni-directional current flow for delivering the substance into the body is maintained at the substance-delivery site.

49. The device according to claim 36, wherein said circuitry supplies currents to said electrodes so that a uni-directional current for delivering the substance into the skin is maintained at the substance-delivery site and a bi-directional current flow is maintained through the skin.

50. The device according to claim 36, wherein the area of said auxiliary electrode is small compared to the area of said treatment electrode.

40. An electrokinetic drug delivery device for personal use and self-administration of a medicament into an individual'"'"'s skin, comprising:

an assembly having an outer surface, a portion thereof shaped for grasping within an individual'"'"'s hand for manual manipulation by the individual;

a self-contained alternating current source of a predetermined frequency within said assembly;

electrodes coupled to said alternating current source, said electrodes including a treatment electrode adapted for electrically contacting a substance-delivery site on the skin, a counter electrode and an auxiliary electrode; and

circuitry coupled between said electrodes and said alternating current source for supplying currents to said electrodes when said electrodes are in electrical contact with the skin in order to deliver the substance into the body at the substance-delivery site.

41. The device according to claim 40, wherein the predetermined frequency of said alternating current source is about 100 kilohertz.

42. The device according to claim 40, wherein the predetermined frequency of said alternating current source is between about 1 kilohertz and 1 megahertz.

43. The device according to claim 40, wherein the magnitude of the unidirectional current is about 1 milliamp (RMS).

44. The device according to claim 40, wherein the magnitude of the unidirectional current is between about 10 microamps (RMS) and 1 milliamp (RMS).

45. The device according to claim 40, wherein the rectifying circuit is a diode.

46. The device according to claim 40, wherein the substance is medicament.

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

an alternating current source;

a plurality of electrodes; 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 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 through the body.

52. The system according to claim 51, wherein the plurality of electrodes comprises at least three electrodes including a treatment electrode, a counter electrode and an auxiliary electrode.

53. The system according to claim 51, wherein the circuitry comprises one or more rectifiers.