METHOD AND SYSTEM FOR MITIGATING CURRENT CONCENTRATION IN ELECTROKINETIC DRUG DELIVERY

• US 20080312579A1
• Filed: 06/16/2008
• Published: 12/18/2008
• Est. Priority Date: 06/15/2007
• Status: Abandoned Application

• Current Assignee: Nitric Biotherapeutics, Inc.
• Original Assignee: Transport Pharmaceuticals, Inc. (NB Therapeutics)
• Inventors: Chang, Kuowei, Barsness, Michael S., Etheredge, Robert W., Goldberg, Dennis I.
• Application Number:
  US12/139,873
• Publication Number:
  US 20080312579A1
• Time in Patent Office: Days
• US Class Current: 604/20
• CPC Class Codes: A61N 1/0412 Specially adapted for transcutaneous electroporation, e.g. including drug reservoirs
• CPC Class Codes: A61N 1/0424 Shape of the electrode
• CPC Class Codes: A61N 1/0428 Specially adapted for iontophoresis, e.g. AC, DC or including drug reservoirs
• CPC Class Codes: A61N 1/044 Shape of the electrode
• CPC Class Codes: A61N 1/0448 Drug reservoir

Abstract

An electrokinetic apparatus to apply medicament to a treatment site of a mammalian user, the apparatus including: a segmented active electrode; a medicament matrix having one side abutting the segmented active electrode and another side adapted to contact a surface of skin over the treatment site, wherein the matrix includes at least one current direction barrier suppressing transverse current flow through the matrix.

Claims

1. An electrokinetic apparatus to apply medicament to a treatment site of a mammalian user, the apparatus comprising:

a segmented active electrode;

a medicament matrix having one side abutting the segmented active electrode and another side adapted to contact a surface of skin over the treatment site, wherein the apparatus includes at least one current direction control element suppressing transverse current flow through the matrix.

2. An electrokinetic apparatus as in claim 1 wherein the current direction control element is a foam having generally aligned dielectric structures.

3. An electrokinetic apparatus as in claim 1 wherein the current direction control element is a honeycombed structure of the matrix.

4. An electrokinetic apparatus as in claim 1 wherein the current direction control element includes a barrier wall.

5. An electrokinetic apparatus as in claim 4 wherein the barrier wall comprises silicone rubber.

6. An electrokinetic apparatus as in claim 1 further comprising a current limiting device electrically connected in series to each segment of the segmented active electrode.

7. An electrokinetic apparatus as in claim 6 wherein the current limiting device is a diode.

8. An electrokinetic apparatus as in claim 1 wherein each segment of the segmented active electrode is separated by a dielectric gap from other segments.

9. An electrokinetic apparatus as in claim 1 further comprising a cartridge housing the matrix and segmented active electrode, wherein the cartridge is releasable attached to a housing including a power supply and electronic control unit for the active electrode.

10. A method to electrokinetically deliver a medicament to a treatment site in a mammalian user, the method comprising:

applying a first surface of a medicament matrix to a surface on the user;

applying a segmented first electrode to a second surface of the medicament matrix;

applying electrical current to an electrical current path extending through the first electrode segments, medicament matrix, at least partially through the user and to a second electrode;

delivering medicament from the matrix into the nail by electrokinetic transporting the medicament along the current path, and blocking transverse current from one electrode segment of the first electrode to the surface on the user not aligned with the one electrode segment.

11. A method as in claim 10 wherein the first electrode is an active electrode and a second electrode is a counter electrode, wherein current flows from the active electrode to the counter electrode.

12. A method as in claim 10 wherein the blocking of transverse current occurs in the matrix.

13. A method as in claim 10 wherein the matrix includes generally aligned dielectric structures that blocks transverse current.

14. A method as in claim 10 wherein the matrix includes a honeycombed structure that blocks transverse current.

15. A method as in claim 10 wherein the blocking of transverse current is performed by electrically coupling a pair of active and counter electrode segments and isolating each pair from another pair of active and counter electrode segments.

16. A method as in claim 15 wherein the pair of active and counter electrode segments is coupled to a secondary winding of a transformer, and another secondary winding is coupled t the another pair of active and counter electrode segments.

17. An electrokinetic apparatus to apply medicament to a treatment site of a mammalian user, the apparatus comprising:

an active electrode including first and second active electrode segments;

a counter electrode including first and second counter electrode segments;

a medicament matrix having one side abutting the segments of the active electrode and another side adapted to contact a surface of the user over the treatment site, wherein the matrix includes at least one current direction barrier suppressing transverse current flow through the matrix;

a first electrical circuit including the first active electrode segment and the first counter electrode segment, and

a second electrical circuit including the second active electrode segment and the second counter electrode segment, wherein the first electrical circuit is electrically isolated from the second electrical circuit.

18. An electrokinetic apparatus as in claim 17 wherein the surface of the user is a nail of a toe or finger, and the medicament matrix is a porous sheet applied to the nail.

19. An electrokinetic apparatus as in claim 17 wherein the first electrical circuit includes a first secondary winding of a transformer and the second electrical circuit includes a second secondary winding.

20. An electrokinetic apparatus as in claim 17 wherein the first and second secondary windings are electromagnetically coupled to a common primary winding of the transformer.

21. An applicator panel for an electrokinetic delivery system comprising:

an array of electrodes arranged on a flexible substrate and conductive pathways between each of the electrodes and a connector to receive a connection to a electronic control and power source circuit, wherein each electrode includes a center active electrode region and an outer return electrode region proximate to the active electrode region, and

at least one layer having a pattern of medicament cells and network of ribs between the cells, wherein the non-woven layer has a back surface laminated to the array of electrodes and the cells are each aligned with a respective one of the electrodes.

22. The applicator panel of claim 21 further comprising an adhesive matrix on a front surface of the non-woven layer, wherein the adhesive is aligned with the network of ribs, wherein the non-woven layer is sandwiched between the array of electrodes and the adhesive matrix.

23. The applicator panel of claim 21 wherein the at least one non-woven layer has a plurality of sub-layers each of which includes a pattern of medicament cells which are offset from medicament cells in the other sub-layers when the sub-layers are laminated together.

24. The applicator panel of claim 23 wherein each sub-layer includes apertures which align with the medicament cells in the other sub-layers when the sub-layers are laminated together.

25. The applicator panel of claim 23 wherein one of the sub-layers includes a medicament different from a medicament in another of the sub-layers.

26. The applicator panel of claim 21 wherein the array of electrodes includes a plurality of zones of electrodes wherein each zone of electrodes is separately controlled by a controller and power source, and each zone aligns with a different group of the cells.

27. The applicator panel of claim 21 wherein the array of electrodes includes a plurality of separate electrode panels and each panel aligned with a different group of the cells in the at least one non-woven layer.

28. The applicator panel of claim 27 wherein each of the electrode panels includes at least a first zone of electrodes and a second zone of electrodes, wherein the first zone of electrodes in each of the panels are activated by a power source simultaneously and the second zone of electrodes in each of the panels are active by the power source simultaneously and separately of the first zone of electrodes.

29. The applicator panel of claim 21 wherein the electrodes each include a center active electrode, a counter electrode surrounding the active electrode and an insulating ring between the active electrode and counter electrode.

30. An applicator for an electrokinetic delivery system comprising:

an array of electrodes arranged on a substrate and conductive pathways between each of the electrodes and a connector to receive a connection to a electronic control and power source circuit, wherein the electrodes are arranged in at least a first commonly connected group of electrodes and a second commonly connected group of electrodes;

a first medicament layer having a pattern of first medicament cells, wherein the first medicament cells are aligned with the electrodes of the first commonly connected group of electrodes;

a second medicament layer having a pattern of second medicament cells, wherein the second medicament cells are aligned with the electrodes of the second commonly connected group of electrodes, and

an electronic controller controlling the electrokinetic delivery to a treatment site of a patient and underlying the first and second medicament layers, wherein medicament in the first medicament layer is delivered by electrically actuating the first commonly connected group of electrodes and medicament in the second medicament layer is delivered by electrically actuating the second commonly connected group of electrodes.

31. The applicator in claim 30 wherein the pattern of first medicament cells and the pattern of second medicament cells are embossed and the first medicament layer and second medicament layer each comprise a network of ribs between the medicament cells.

32. The applicator in claim 30 wherein the first medicament cells include a first medicament and the second medicament cells include a second medicament different than the first medicament.

33. An applicator panel for an electrokinetic delivery system comprising:

an array of electrodes arranged on a flexible substrate and conductive pathways between each of the electrodes and a connector to receive a connection to a electronic control and power source circuit;

at least one non-woven layer having a pattern of medicament cells and ribs between the cells, wherein the cells are aligned with electrodes of the array;

an adhesive matrix where the adhesive is aligned with the ribs, wherein the non-woven layer is sandwiched between the array of electrodes and the adhesive matrix.

34. The applicator panel as in claim 33 wherein the pattern of medicament cells are embossed on the non-woven layer.

35. The applicator panel as in claim 33 wherein the ribs are ridges raised on a side of the non-woven layer facing the array of electrodes.

36. The applicator panel as in claim 35 wherein the ridges do not rise above a front surface of each of the cells on a side of the non-woven layer opposite to the array of electrodes.

37. The applicator panel as in claim 33 wherein the ribs form a network of rows and columns between the cells.

38. A method to form an applicator panel for an electrokinetic delivery system comprising:

embossing a pattern of medicament cells and ridges on a non-woven layer;

infusing a medicament into the medicament cells;

forming an electrode layer by applying an array of electrodes on a front side of an electrode layer substrate and forming an electrical distribution circuit on a back side of the electrode layer substrate, and

securing the front side of the electrode layer substrate to a back side of the non-woven layer, wherein the electrodes are aligned with the medicament cells.

39. The method of claim 38 further comprising forming a first sub-layer and a second sub-layer of the non-woven layer, wherein each of the sub-layers includes a separate group of the medicament cells and the group of the medicament cells in the first sub-layer is non-overlapping with the group of the medicament cells in the second sub-layer.

40. An array of electrodes in an applicator panel for an electrokinetic delivery system including a medicament layer having an array of medicament cells, each of the electrodes comprising:

a center electrode region aligned with one of the medicament cells;

a non-conductive region surrounding the center electrode, and

a neutral return electrode region encircling the annular adhesive seal.

41. The array of electrodes in claim 40 wherein the non-conductive region of each electrode is a ring.

42. The array of electrodes as in claim 40 wherein the center region in each of a first plurality of the electrodes is a cathodic center region coupled to a source of positive voltage and the center region in each of a second plurality of the electrodes is an anodic center region coupled to a source of negative voltage.

43. The array of electrodes as in claim 42 wherein the first plurality of the electrodes with the cathodic center regions are intermingled with the second plurality of the electrodes with the anodic center regions.

44. The array of electrodes as in claim 42 wherein the first plurality of the electrodes with the cathodic center regions are arranged in a group separate from the second plurality of the electrodes with the anodic center regions.

45. The array of electrodes as in claim 42 wherein the non-conductive region of each electrode includes an adhesive to bind the electrode to the medicament layer.

46. The array of electrodes as in claim 42 wherein a width of the non-conductive ring determines a depth of medicament delivery into skin, and the width is selected to achieve a desired depth of medicament delivery.

47. The array of electrodes as in claim 42 further comprising a current regulation circuit electrically coupled to each electrode.

48. The array of electrodes as in claim 47 wherein there is one of the current regulation circuits for each electrode.