Iontophoretic electrode with improved current distribution

• US 6,731,977 B2
• Filed: 01/22/2001
• Issued: 05/04/2004
• Est. Priority Date: 01/22/2001
• Status: Expired due to Term

• Current Assignee: Encore Medical Asset Corporation (Enovis Corp.)
• Original Assignee: Iomed, Inc. (Enovis Corp.)
• Inventors: Beck, Jon E.
• Primary Examiner(s): Bockelman, Mark
• Application Number:
  US09/766,767
• Publication Number:
  US 20020099320A1
• Time in Patent Office: 1,198 Days
• Field of Search: 604/20, 607/152, 607/115, 600/372
• US Class Current: 604/20
• CPC Class Codes: A61N 1/0436 Material of the electrode
• CPC Class Codes: A61N 1/044 Shape of the electrode
• CPC Class Codes: A61N 1/0492 Patch electrodes A61N1/0412, A61N1/0428 take precedence
• CPC Class Codes: A61N 1/303 Constructional details electrodes for external use A61N1/0428

Abstract

An electrode for use in an iontophoretic drug delivery having a substantially uniform distribution of current about the electrode. One such electrode includes a substrate, at least one first conductive layer of material disposed upon the substrate and at least one dielectric layer of material disposed upon at least a portion of the at least one conductive layer of material. The dielectric layer cooperates with the conductive layer of material to promote the substantially uniform distribution of current. Another such electrode includes a substrate, a conductive layer of material and a sacrificial layer of material.

Claims

1. An electrode, for use in an iontophoretic drug delivery apparatus, comprising:

at least one first conductive layer of material having a proximal end, a distal end, and an axis extending between the proximal and distal end, wherein the conductive layer undergoes an electrochemical reaction upon application of an electric current, the conductive layer having at least one lead attachment region associated with the proximal end; and

at least one dielectric layer of material disposed upon at least a portion of, but less than the entirety of, the at least one conductive layer of material, wherein the dielectric layer is configured in a continuous and uninterrupted pattern extending from the at least one lead attachment region to a region of the conductive layer distally spaced from the lead attachment region, the pattern comprising a substantially linear trunk running along the axis of the conductive layer, having at least one terminal end.

2. The electrode of claim 1 further comprising at least one second conductive layer of material disposed upon the at least one of the at least one conductive layer of material which remains exposed and the at least one dielectric layer of material.

3. The electrode of claim 1 wherein the pattern is formed into a substantially contiguous herringbone pattern.

4. The electrode of claim 1 wherein the pattern comprises at least one strip.

5. The electrode of claim 4 wherein the at least one terminal end is configured to include a taper, to, in turn, preclude concentrations of current therearound.

6. The electrode of claim 1 wherein the pattern is substantially symmetrical from the proximal to the distal end of the conductive layer of material about the axis, wherein the axis bisects the conductive layer of material.

7. The electrode of claim 1 further including a substrate associated with the first layer of material.

8. The electrode of claim 1, wherein the pattern further comprises at least one branch.

9. An electrode, for use in an iontophoretic drug delivery apparatus, comprising:

a first conductive layer of material, which does not undergo a chemical reaction upon application of an electrical current, the first conductive layer having at least one lead attachment region; and

at least one sacrificial layer of material disposed upon at least a portion of the at least one conductive layer of material and having a proximal end, a distal end, and an axis extending between the proximal and distal end, wherein the lead attachment region of the first conductive layer is associated with the proximal end;

wherein the first conductive layer of material is configured in a continuous and uninterrupted pattern extending from the at least one lead attachment region to a region of the at least one sacrificial layer of material proximate the distal end, wherein the pattern comprises a substantially linear trunk running along the axis of the sacrificial layer, having at least one terminal end.

10. The electrode of claim 9 wherein the first conductive layer is configured so as to substantially correspond to the dimensions of the at least one sacrificial layer of material.

11. The electrode of claim 9 wherein the pattern comprises a plurality of intersecting strips of material.

12. The electrode of claim 9 wherein the pattern comprises a herringbone pattern.

13. The electrode of claim 9 further comprising a transitional conductive material positioned between the conductive layer of material and the sacrificial layer of material.

14. The electrode of claim 9 further comprising a substrate associated with the conductive layer of material.

15. The electrode of claim 9, wherein the pattern further comprises at least one branch.

21. The method of claim 15, wherein the pattern further comprises at least one branch.

16. A method of manufacturing an electrode for use in association with an iontophoretic drug delivery apparatus comprising the steps of:

providing a substrate;

applying a conductive layer of material upon at least a portion of the substrate, the conductive layer having a proximal end, a distal end, and an axis extending between the proximal and distal end, wherein the conductive layer undergoes an electrochemical reaction upon application of an electric current, the conductive layer having at least one lead attachment region associated with the proximal end; and

applying a dielectric layer of material upon a portion of, but less than the entirety of the conductive layer of material, wherein the dielectric layer is configured in a continuous and uninterrupted pattern extending from the at least one lead attachment region along the axis of the conductive layer to a region of the conductive layer proximate the distal end, the pattern comprising a substantially linear trunk running along the axis of the conductive layer, and having at least one terminal end.

17. The method of claim 16 further comprising the step of:

associating a lead with the at least one attachment region.

18. The method of claim 16 further comprising the step of:

applying at least one conductive layer upon at least one of the exposed conductive layer of material and the dielectric layer of material.

19. The method of claim 16 wherein the step of applying a conductive layer of material comprises the step of:

printing the conductive layer of material upon the substrate.

20. The method of claim 16 wherein the step of applying a dielectric layer of material comprises the step of:

printing the dielectric layer of material upon the substrate.

22. A method of manufacturing an electrode for use in association with an iontophoretic drug delivery apparatus comprising the step of:

providing a substrate;

applying a conductive layer of material upon a portion of the substrate, which does not undergo a chemical reaction upon application of an electric current, the conductive layer having at least one lead attachment region; and

applying a sacrificial layer of material upon the conductive layer of material, the sacrificial layer having a proximal end, a distal end, and an axis extending between the proximal and distal end, wherein the lead attachment region is associated with the proximal end;

wherein the first conductive layer of material is applied to the substrate in a continuous and uninterrupted pattern extending from the at least one lead attachment region along the axis of the sacrificial layer to a region of the at least one sacrificial layer proximate the distal end of the sacrificial layer, wherein the pattern comprises a substantially linear trunk running along the axis of the sacrificial layer, and having at least one terminal end.

23. The method of claim 22 wherein the step of applying a conductive layer comprises the step of:

printing the conductive layer of material upon the substrate.

24. The method of claim 22 wherein the step of applying a sacrificial layer of material comprises the step of:

printing the sacrificial layer of material upon at least a portion of the conductive layer.

25. The method of claim 22 further comprising the step of:

applying a transition conductive layer after the step of applying a conductive layer of material.

26. The method of claim 22, wherein the pattern further comprises at least one branch.