Iontophoresis apparatus and method

• US 7,996,077 B2
• Filed: 04/10/2007
• Issued: 08/09/2011
• Est. Priority Date: 09/06/2006
• 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): Stigell; Theodore J
• Assistant Examiner(s): CARPENTER, WILLIAM R
• Application Number:
  US11/733,692
• Publication Number:
  US 20080058699A1
• Time in Patent Office: 1,582 Days
• Field of Search: 604 20- 22, 607 62- 63
• 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 iontophoretic transdermal process to a body site comprising the steps of:

positioning an iontophoretic patch at a body site;

attaching a removable controller to the iontophoretic patch;

receiving, at the removable controller, a selection of a treatment mode from a plurality of treatment current modes;

applying an electrical current to the body site with the removable controller during a first period of time, prior to applying an iontophoretic treatment, to enhance the electrical conductivity of the body site;

measuring an elapsed time from a start of the first period of time, during which a decrease in an electrical conductivity characteristic of the body site occurs indicative of the response of the body site to the applied electrical current;

discontinuing electrical conductivity enhancement based at least in part on the measured elapsed time; and

applying the iontophoretic treatment to the body site, wherein the duration of the iontophoretic treatment is based at least in part on the electrical conductivity characteristic and wherein applying the iontophoretic treatment to the body site is automatically initiated when the controller is disconnected from the iontophoretic patch.

2. The method of claim 1 wherein receiving a treatment mode from a plurality of treatment current modes comprises the steps of:

receiving a selection of one of first, second and third current modes; and

generating about 2 milliAmps when the first current mode is selected, generating about 3 milliAmps when the second current mode is selected, and generating about 4 milliAmps when the third current mode is selected.

3. The method of claim 1 wherein receiving a treatment mode from a plurality of treatment current modes comprises the steps of:

receiving a selection of one of first, second and third current modes; and

generating about 0.5 milliAmps when the first current mode is selected, generating about 1 milliAmp when the second current mode is selected, and generating about 1.5 milliAmps when the third current mode is selected.

4. The method of claim 1 wherein the step of applying an electrical current to a body site to enhance 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.

5. The method of claim 1 wherein the step of applying an electrical current to a body site to enhance 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.

6. The method of claim 1 wherein the step of applying an electrical current to a body site to enhance the electrical conductivity of the body site includes the step of applying a current of about 3 milliAmp to the body site.

7. The method of claim 1 wherein the step of applying an electrical current to a body site to enhance 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.

8. The method of claim 1 wherein the step of applying an iontophoretic treatment to the body site includes the step of supplying power from an integral power source to a patch connected to the body site.

9. The method of claim 1 further comprising the step of providing an indication when the electrical conductivity of the body site has not been adequately enhanced as determined based at least in part on the calculated number.

10. The method of claim 1 further comprising the step of disconnecting the controller from the iontophoretic patch attached to the body site prior to applying the iontophoretic treatment to the body site.

11. The method of claim 1, wherein applying the iontophoretic treatment for a duration based at least in part on the electrical conductivity characteristic is based at least in part on a calculated number indicative of a change in a property of the body site after completion of the applied electrical current.

12. The method of claim 1, wherein the calculated number is based at least in part on a pre-determined conductivity ratio and a measurement of the electrical conductivity characteristic.

13. The method of claim 12, wherein the pre-determined conductivity ratio is based at least in part on the body site.

14. The method of claim 12, wherein the pre-determined conductivity ratio is indicative of a decrease in electrical conductivity of the body site.

15. The method of claim 14, wherein the pre-determined conductivity ratio is based at least in part on a conductivity near the completion of the applied electrical current and a conductivity after the completion of the applied electrical current at a voltage corresponding to a DC voltage iontophoretic treatment.

16. The method of claim 1, wherein the iontophoretic treatment is not applied when a measured electrical conductivity characteristic exceeds a threshold.

17. The method of claim 1, wherein a voltage of the iontophoretic treatment is based at least in part on the calculated number.

18. The method of claim 1, wherein the step of applying an iontophoretic treatment to a body site is based at least in part on a measured electrical conductivity characteristic.

19. The method of claim 18, wherein the measured electrical conductivity characteristic is a rate of change of conductivity.

20. The method of claim 18, wherein the measured electrical conductivity characteristic is a resistance measurement and an approximate resistance during the adjustable iontophoretic treatment is calculated.

21. The method of claim 18, wherein the measured electrical conductivity characteristic is a resistance measurement and an approximate time for the adjustable iontophoretic treatment is calculated.

22. The method of claim 18, wherein the measured electrical conductivity characteristic is a current measurement and an approximate resistance during the adjustable iontophoretic treatment is calculated.

23. The method of claim 18, wherein the measured electrical conductivity characteristic comprises a plurality of measurements over an interval of time, and an average of the plurality of measurements is calculated.

24. The method of claim 1, wherein the applied iontophoretic treatment is also based on the selected treatment mode.

25. The method of claim 1, wherein identifying a treatment mode from a plurality of treatment current modes comprises identifying a connector on a treatment patch.

26. The method of claim 25, wherein identifying a connector comprises detecting a jumper position.

27. The method of claim 1, wherein a current applied to the body site during the iontophoretic treatment is not regulated by an electronic current regulator.

28. The method of claim 1, wherein the iontophoretic treatment is open-loop.

29. The method of claim 1, wherein the electrical current applied to a body site to enhance the electrical conductivity of the body site during an enhancement phase is a DC current.

30. The method of claim 29, wherein the iontophoretic treatment is a DC voltage treatment.

31. The method of claim 1, wherein applying the iontophoretic treatment for a duration based at least in part on the electrical conductivity characteristic comprises terminating the treatment using an electrochemical overdose limitation switch.

32. The method of claim 1, wherein a mechanical switch is used to automatically initiate the iontophoretic treatment when the controller is disconnected from the iontophoretic patch.

33. The method of claim 1, wherein receiving, at the removable controller, a selection of a treatment mode from a plurality of treatment current modes comprises receiving a selection signal from a user input interface on the removable controller.

34. The method of claim 1, wherein receiving a selection of a treatment mode from a plurality of treatment current modes comprises detecting a selection signal when the removable controller is attached to the iontophoretic patch.

35. The method of claim 1, wherein receiving a selection of a treatment mode from a plurality of treatment current modes comprises identifying a connector on the iontophoretic patch when the removable controller is attached to the iontophoretic patch.

36. The method of claim 1, wherein receiving a selection of a treatment mode from a plurality of treatment current modes comprises receiving information at a processor in the removable controller that identifies a treatment mode associated with the iontophoretic patch.