Apparatus for electrotherapy drug delivery with added impurities

• US 8,386,029 B2
• Filed: 03/31/2005
• Issued: 02/26/2013
• Est. Priority Date: 03/31/2005
• Status: Active Grant

• Current Assignee: Encore Medical Asset Corporation (Enovis Corp.)
• Original Assignee: Encore Medical Asset Corporation (Enovis Corp.)
• Inventors: Hause, Robert F. Jr., Beck, Jon E.
• Primary Examiner(s): Sirmons, Kevin C
• Assistant Examiner(s): OSINSKI, BRADLEY JAMES
• Application Number:
  US10/907,429
• Publication Number:
  US 20060229549A1
• Time in Patent Office: 2,889 Days
• Field of Search: 600/396, 604/20, 604/890.1, 604/21
• US Class Current: 604/20
• CPC Class Codes: A61N 1/0428 Specially adapted for iontophoresis, e.g. AC, DC or including drug reservoirs
• CPC Class Codes: A61N 1/0436 Material 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

The present invention is directed to a method and apparatus for an electrotherapeutic system including a first and second electrode. Each electrode includes a respective resistance wherein during operation of the electrotherapeutic system, an electrochemical reaction involving one or both of the electrodes varies the respective resistance of at least one of the electrodes.

Claims

1. A current distribution element for an electrotherapeutic system including a power source for driving an electrolytic chemical reaction and facilitating delivery of a drug dose, the current distribution element comprising:

a first electrode including a first material having a resistance, and-configured to deliver a drug dose; and

a second electrode including a second material having a resistance, and configured to return current to the power source;

wherein current is delivered from the first electrode to the second electrode, thereby delivering the drug dose and causing electroplating on the second electrode with a nonconductive substance formed from the second material wherein impurities added to the second material facilitate electroplating on the second electrode, thereby varying the resistance over time in accordance with a predetermined resistance profile.

2. The current distribution element of claim 1 further comprising:

a power source connector being operably connected between the first and second electrodes;

a first terminal being operably connected to the power source connector;

a second terminal being operably connected to the power source connector;

a first conductor being operably connected between the first terminal and the first electrode; and

,

a second conductor being operably connected between the second terminal and the second electrode.

3. The current distribution element of claim 2 wherein the first conductor and the first electrode comprise the same metal composition.

4. The current distribution element of claim 3 wherein the metal composition comprises Ag.

5. The current distribution element of claim 3 wherein the metal composition comprises Ag/AgCl.

6. The current distribution element of claim 2 wherein the second conductor and the second electrode comprise the same metal composition.

7. The current distribution element of claim 6 wherein the metal composition comprises Ag.

8. The current distribution element of claim 6 wherein the metal composition comprises Ag/AgCl.

9. The current distribution element of claim 2 wherein the first conductor, the first electrode, the second conductor, and the second electrode comprise the same metal composition.

10. The current distribution element of claim 9 wherein the metal composition comprises Ag.

11. The current distribution element of claim 9 wherein the metal composition comprises Ag/AgCl.

12. The current distribution element of claim 2 further comprising:

a current regulator being operably connected between the power source connector and either the first or second electrode.

13. The current distribution element of claim 12 wherein the current regulator is a resistor.

14. The current distribution element of claim 13 wherein the resistor is printed.

15. The current distribution element of claim 13 wherein the resistor is a discrete component.

16. The current distribution element of claim 13 wherein the value of the resistor being selected in response to power source voltage, maximum required current, or the application of the electrotherapeutic system.

17. The current distribution element of claim 1 further comprising:

a first hydratable matrix being operably attached to the first electrode; and

,

a second hydratable matrix being operably attached to the second electrode.

18. The current distribution element of claim 17 wherein either the first or second hydratable matrix includes an ionic medicament.

19. The current distribution element of claim 17 wherein either the first or second hydratable matrix includes a non-drug ionic electrolyte.

20. The current distribution element of claim 17, wherein a solution in at least one of the first and second hydratable matrices undergoes a chemical reaction with a metal in at least one of the first and second electrode thereby varying the resistance of said electrode.

21. The current distribution element of claim 17, wherein the second hydratable matrix includes an electrolyte, and wherein the properties of the second electrode and the properties of the electrolyte are configured to produce a chemical reaction which controls delivery of the drug to deliver a pre-determined dose.

22. The current distribution element of claim 1 wherein the power source is a battery.

23. The current distribution element of claim 1 wherein the power source is an electrochemical storage device.

24. The current distribution element of claim 1 wherein the power source includes an electrical generator and/or an electrostatic storage device.

25. The current distribution element of claim 1 further comprising a means for varying the resistance of the first electrode and/or the second electrode.

26. The current distribution element of claim 1, wherein the electroplating process terminates the drug dose delivered by the first electrode.

27. The current distribution element of claim 1, wherein the impurities are added to the surface area of the electrode.

28. The current distribution element of claim 1, wherein the electroplating causes termination of the current.

29. The current distribution element of claim 28, wherein the current is terminated once the final desired drug dose is achieved.

30. An electrotherapeutic system comprising:

a housing;

a current distribution element including a first electrode including a first material having a resistance, and configured to deliver a drug dose and a second electrode including a second material having a resistance, the current distribution element being attached to the housing,

a power source being operably connected between the first and second electrodes, wherein the second electrode is configured to return current to the power source;

a first hydratable matrix being operably attached to the first electrode, the first hydratable matrix containing a first ionic solution;

a second hydratable matrix being operably attached to the second electrode, the second hydratable matrix containing a second ionic solution,

wherein current is delivered from the first electrode to the second electrode, thereby delivering the drug dose and, wherein interaction of the second hydratable matrix with the second electrode causes electroplating on the second electrode with a nonconductive substance formed from the second material, wherein a composition of the second hydratable matrix is configured to facilitate the electroplating thereby varying a resistance over time in accordance with a predetermined resistance profile.

31. The electrotherapeutic system of claim 30 further comprising:

a first conductor being operably connected between the power source and the first electrode; and

,

a second conductor being operably connected between the power source and the second electrode.

32. The electrotherapeutic system of claim 31 wherein the first conductor and the first electrode comprise the same metal composition.

33. The electrotherapeutic system of claim 32 wherein the metal composition comprises Ag.

34. The electrotherapeutic system of claim 32 wherein the metal composition comprises Ag/AgCl.

35. The electrotherapeutic system of claim 31 wherein the second conductor and the second electrode comprise the same metal composition.

36. The electrotherapeutic system of claim 35 wherein the metal composition comprises Ag.

37. The electrotherapeutic system of claim 35 wherein the metal composition comprises Ag/AgCl.

38. The electrotherapeutic system of claim 31 wherein the first conductor, the first electrode, the second conductor, and the second electrode comprise the same metal composition.

39. The electrotherapeutic system of claim 38 wherein the metal composition comprises Ag.

40. The electrotherapeutic system of claim 38 wherein the metal composition comprises Ag/AgCl.

41. The electrotherapeutic system of claim 30 wherein the power source is a battery.

42. The electrotherapeutic system of claim 30 wherein the power source is an electrochemical storage device.

43. The electrotherapeutic system of claim 30 wherein the power source is an electrical generator and/or an electrostatic storage device.

44. The electrotherapeutic system of claim 30 further comprising:

a current regulator being operably connected between the power source and either the first or second electrode.

45. The electrotherapeutic system of claim 44 wherein the current regulator is a resistor.

46. The electrotherapeutic system of claim 45 wherein the resistor is printed.

47. The electrotherapeutic system of claim 45 wherein the resistor is a discrete component.

48. The electrotherapeutic system of claim 45 wherein the value of the resistor being selected in response to power source voltage, maximum required current, or the application of the electrotherapeutic system.

49. The electrotherapeutic system of claim 30 further comprising a means for varying the resistance of the first electrode and/or the second electrode.

50. The electrotherapeutic system of claim 30 wherein the housing includes an adhesive for facilitating attachment to a body.

51. The electrotherapeutic system of claim 30 wherein the first ionic solution and the second ionic solution are identical.

52. The electrotherapeutic system of claim 30 wherein the first ionic solution includes a medicament.

53. The electrotherapeutic system of claim 30 wherein the first ionic solution includes a non-drug electrolyte.

54. The electrotherapeutic system of claim 30, wherein the electroplating causes termination of the current.

55. The electrotherapeutic system of claim 54, wherein the current is terminated once the final desired drug dose is achieved.

56. A current distribution element for an electrotherapeutic system including a power source for driving an electrolytic chemical reaction, the current distribution element comprising:

a first electrode including a first material having a resistance;

a second electrode including a second material having a resistance; and

,

a power source connector being operably connected between the first and second electrodes, wherein during operation of the electrotherapeutic system, an electrochemical reaction causes electroplating on the second electrode with a nonconductive substance formed from the second material wherein impurities added to the second material facilitate electroplating on the second material, thereby varying the resistance over time in accordance with a predetermined resistance profile.

57. The current distribution element of claim 56, wherein the impurities are added to the surface area of the electrode.

58. The current distribution element of claim 56, wherein the electroplating causes termination of the current.

59. An electrotherapeutic system comprising:

a housing;

a current distribution element including a first electrode including a first material having a resistance, and a second electrode including a second material having a resistance, the current distribution element being attached to the housing;

a power source being operably connected between the first and second electrodes;

a first hydratable matrix being operably attached to the first electrode, the first hydratable matrix containing a first ionic solution;

a second hydratable matrix being operably attached to the second electrode, the second hydratable matrix containing a second ionic solution;

wherein during operation of the electrotherapeutic system, an electrochemical reaction involving a portion of the current distribution element in combination with the second hydratable matrix and its respective ionic solution causes electroplating on the second electrode with a nonconductive substance formed from the second material, wherein a composition on the second hydratable matrix is configured to facilitate the electroplating thereby varying a resistance over time in accordance with a predetermined resistance profile.

60. The electrotherapeutic system of claim 59, wherein the electroplating causes termination of the current.