IONTOPHORESIS APPARATUS AND METHOD

• US 20080058699A1
• Filed: 04/10/2007
• Published: 03/06/2008
• Est. Priority Date: 09/06/2006
• Status: Active Grant

• Current Assignee: Encore Medical Asset Corporation (Enovis Corp.)
• Original Assignee: Iomed, Inc. (Enovis Corp.)
• Inventors: Beck, Jon E., Hause, Robert F.
• Granted Patent: US 7,996,077 B2
• Time in Patent Office: Days
• US Class Current: 604/20
• CPC Class Codes: A61N 1/0428 Specially adapted for iontophoresis, e.g. AC, DC or including drug reservoirs

Abstract

An iontophoresis apparatus and method is disclosed that is suited to deliver a plurality of treatment methods such as, but not limited to, body site conductivity enhancement followed by low voltage iontophoresis.

Claims

1. A method for applying an electrical transdermal process to a patient comprising the steps of:

selecting between applying a traditional iontophoretic treatment and a low voltage treatment to the patient with a device, the low voltage iontophoretic treatment comprising the steps of applying an electrical conductivity enhancement treatment to the patient and applying a low voltage iontophoretic treatment to the patient; and

,

applying the selected treatment to the patient with the device.

2. The method of claim 1 wherein the electrical conductivity enhancement treatment is applied before the low voltage iontophoretic treatment.

3. The method of claim 1 wherein the electrical conductivity enhancement treatment is applied as part of the conventional iontophoretic treatment.

4. The method of claim 1 further comprising the step of allowing the patient to leave a medical treatment facility after the electrical conductivity enhancement treatment and during at least a portion of the low voltage iontophoretic treatment.

5. The method of claim 1 further comprising the step of indicating on a display the time remaining to complete the application of the electrical transdermal process to the patient.

6. The method of claim 1 further comprising the step of referring to a chart to determine the time remaining to complete the application of the electrical transdermal process to the patient.

7. The method of claim 1 further comprising the step of determining an optimal time to lower skin conductivity of at least one membrane of the patient.

8. The method of claim 7 wherein drug transport is increased by lowering of the membrane resistance.

9. The method of claim 7 further comprising the step of determining an optimal time to enhance the electrical conductivity of the least one membrane to enhance drug transport.

10. The method of claim 7 wherein the step of determining the optimal time to lower membrane resistance includes the step of measuring electrical parameters.

11. The method of claim 10 wherein the step of determining the optimal time to lower membrane resistance further includes the step of calculating electrical parameters.

12. The method of claim 10 wherein the step of determining the optimal time to lower membrane resistance further includes the step of ramping down an applied current once a slope of the voltage is at or below a threshold.

13. The method of claim 10 wherein the step of determining the optimal time to lower membrane resistance further includes the step of ramping down an applied current once a magnitude of the voltage is at or below a threshold.

14. The method of claim 10 wherein the step of determining the optimal time to lower membrane resistance further includes the step of ramping down an applied current once a slope of the resistance is at or below a threshold.

15. The method of claim 10 wherein the step of determining the optimal time to lower membrane resistance further includes the step of ramping down an applied current once a magnitude of the resistance is at or below a threshold.

16. The method of claim 10 wherein the step of determining the optimal time to lower membrane resistance further includes the step of ramping down an applied current once a slope of the current is at or below a threshold.

17. The method of claim 10 wherein the step of determining the optimal time to lower membrane resistance further includes the step of ramping down an applied current once a magnitude of the current is at or below a threshold.

18. The method of claim 11 wherein the step of determining the optimal time to lower membrane resistance further includes the step of ramping down an applied current once a slope of the current is at or below a threshold.

19. The method of claim 11 wherein the step of determining the optimal time to lower membrane resistance further includes the step of ramping down an applied current once a magnitude of the current is at or below a threshold.

20. A method for applying an iontophoretic transdermal process to a body site comprising the steps of:

determining to apply a treatment mode from one or more treatment modes provided by a device comprising a traditional iontophoresis mode; and

,

determining to apply an electrical conductivity enhancement mode from one or more electrical conductivity enhancement modes provided by the device followed by applying a low voltage iontophoresis mode to the body site.

21. The method of claim 20 further comprising the step of selecting from one or more low voltage iontophoresis modes provided by the device.

22. The method of claim 20 further comprising the steps of generating a low current mode, medium current mode and high current mode by the device wherein the magnitude for each interval is within the range of about 0.1 milliAmps to about 4 milliAmps.

23. The method of claim 20 further comprising the steps of generating about 2 milliAmps in the low current mode, generating about 3 milliAmps in the medium current mode, and generating about 4 milliAmps in the high current mode.

24. The method of claim 20 further comprising the steps of generating about 0.5 milliAmps in the low current mode, generating about 1 milliAmp in the medium current mode, and generating about 1.5 milliAmps in the high current mode.

25. The method of claim 20 further comprising the steps of generating a variable current that is adjusted by a thumbwheel or dial.

26. The method of claim 20 further comprising the step of a direct coupling without wires to a controller to an iontophoretic patch and attaching the patch to the body site.

27. The method of claim 20 further comprising the step of attaching a controller to an iontophoretic patch and attaching the patch to the body site.

28. The method of claim 20 wherein an electronic controller is an integral component of the patch.

29. The method of claim 20 wherein at least one of the electrical conductivity enhancement modes includes the step of applying a current to the body site over a time period of between about 1 minute and about 5 minutes.

30. The method of claim 20 wherein at least one of the electrical conductivity enhancement modes includes the step of adjustably applying a current to the body site.

31. The method of claim 20 wherein at least one of the electrical conductivity enhancement modes includes the step of applying a voltage limited regulated current, wherein the magnitude of the current and voltage is within a range of current magnitudes and voltage magnitudes of about 0.1 milliAmps to about 4 milliAmps and about 0.1 Volts to 110 Volts, respectively.

32. The method of claim 20 wherein at least one of the electrical conductivity enhancement modes includes the step of applying a current density of about 0.5 milliAmp/centimeters² to the body site.

33. The method of claim 20 wherein the step of applying a low voltage iontophoretic transdermal patch treatment to the body site includes the step of supplying power from an integral power source to a patch connected to the body site.

34. The method of claim 20 further comprising the step of determining a treatment time remaining by applying a voltage after the electrical conductivity enhancement, wherein the voltage is approximately equivalent to that used for low voltage iontophoresis.

35. The method of claim 34 further comprising the step of evaluating the current measured.

36. The method of claim 34 further comprising the step of evaluating the resistance.

37. The method of claim 34 wherein the applied voltage is ramped up to about 6 volts.

38. A method comprising the steps of determining the electrical characteristics for a second stage low voltage iontophoresis phase during the first stage electrical of a conductivity enhancement phase and utilizing the electrical characteristics obtained to pre-verify completion of follow-up low voltage iontophoresis phase within a finite period of time.

39. The method of claim 38 further comprising the steps of measuring and evaluating of electrical parameters at a low voltage, during the electrical conductivity enhancement phase wherein the magnitude of the low voltage is similar to that of the voltage employed during the low voltage treatment phase.

40. The method of claim 38 further comprising the step of evaluating the current measured.

41. The method of claim 38 further comprising the step of evaluating the resistance.

42. The method of claim 38 further comprising the steps of measuring and evaluating of electrical parameters at a low voltage, after the electrical conductivity enhancement electrical current ramp-down, but before the electrical conductivity enhancement device operation is terminated, wherein the magnitude of the low voltage is similar to that of the voltage employed during the low voltage treatment phase.

43. The method of claim 42 further comprising the step of evaluating the current measured.

44. The method of claim 42 further comprising the step of evaluating the resistance.

45. The method of claim 38 wherein the electrical characteristics obtained are utilized to pre-verify completion of follow-up low voltage iontophoresis phase within a finite period of time.

46. The method of claim 45 wherein the electrical characteristics obtained are utilized to warn a user if it is determined that the follow-up low voltage iontophoresis phase will not be completed within the finite period of time.

47. The method of claim 38 further comprising the step of utilizing the electrical characteristics obtained to determine an approximate duration for a follow-up low voltage iontophoresis phase.

48. The method of claim 39 further comprising the step of providing an indication of an anticipated treatment duration via a liquid crystal display and in response to the electrical characteristic obtained.

49. The method of claim 48 further comprising an end of treatment indication for the low voltage portion of the treatment.

50. The method of claim 49 wherein the end of treatment indicator that changes colors when the treatment is completed.

51. A method for applying an iontophoretic transdermal process to a body site comprising the steps of:

determining whether to apply a treatment mode from a plurality of treatment modes comprising a low current mode, a medium current mode, a high current mode;

determining whether to enhance the electrical conductivity of the body site; and

,

determining whether to apply the selected treatment mode to the body site.

52. The method of claim 51 further comprising the steps of generating about 2 milliAmps in the low current mode, generating about 3 milliAmps in the medium current mode, and generating about 4 milliAmps in the high current mode.

53. The method of claim 51 further comprising the steps of generating about 0.5 milliAmps in the low current mode, generating about 1 milliAmp in the medium current mode, and generating about 1.5 milliAmps in the high current mode.

54. The method of claim 51 further comprising the steps of generating a variable current that is adjusted by a thumbwheel or dial.

55. The method of claim 51 further comprising the steps of attaching a controller to an iontophoretic patch and attaching the patch to the body site.

56. The method of claim 51 wherein the step of enhancing the electrical conductivity of the body site includes the step of applying a current to the body site over a time period of between about 1 minute and about 5 minutes.

57. The method of claim 51 wherein the step of enhancing the electrical conductivity of the body site includes the step of applying a current density of 0.53 milliAmp/centimeters², or less, to the body site.

58. The method of claim 51 wherein the step of enhancing the electrical conductivity of the body site includes the step of applying a current of about 3 milliAmp to the body site.

59. The method of claim 51 wherein the step of enhancing the electrical conductivity of the body site includes the step of applying a current in a range of about 0.1 to about 4 milliAmp to the body site.

60. The method of claim 51 wherein the step of applying a low voltage iontophoretic transdermal patch treatment to the body site includes the step of supplying power from an integral power source to a patch connected to the body site.

61. The method of claim 51 further comprising the step of providing an indication if the electrical conductivity of the body site has not been adequately enhanced.

62. The method of claim 51 further comprising the step of disconnecting a controller from an iontophoretic transdermal patch connected to the body site before the step of applying the low voltage iontophoretic transdermal patch treatment to the body site.

63. The method of claim 51 further comprising the step of disconnecting the controller from the patch to initiate the treatment.

64. A method for applying an iontophoretic transdermal process to a body site comprising the steps of:

providing a iontophoresis controller having a housing iincluding a key; and

providing an iontophoretic patch having a connector mounted thereon, the connector capable of being operatively attached to the housing via the key.

65. The method of claim 64 wherein the keying is based on the medicine to be applied.