Percutaneous electrode array

• US 7,013,179 B2
• Filed: 06/10/2003
• Issued: 03/14/2006
• Est. Priority Date: 01/07/2000
• Status: Expired due to Term

• Current Assignee: Biowave Corporation
• Original Assignee: Biowave Corporation
• Inventors: Carter, John, Siff, Bradford
• Primary Examiner(s): FUQUA, SHAWNTINA T
• Application Number:
  US10/459,695
• Publication Number:
  US 20030208248A1
• Time in Patent Office: 1,008 Days
• Field of Search: 607/46, 607/67, 607/69, 607/70, 607/72, 607/74, 607/76
• US Class Current: 607/69
• CPC Class Codes: A61N 1/0504 Subcutaneous electrodes
• CPC Class Codes: A61N 1/32 alternating or intermittent currents applying electric fields by inductive or capacitive coupling A61N1/40; microwave apparatus A61N5/02
• CPC Class Codes: A61N 1/36017 with leads or electrodes penetrating the skin
• CPC Class Codes: A61N 1/36021 for treatment of pain
• CPC Class Codes: Y10T 29/49117 Conductor or circuit manufacturing
• CPC Class Codes: Y10T 29/49174 Assembling terminal to elongated conductor

Abstract

A percutaneous electrode array is disclosed for applying therapeutic electrical energy to a treatment site in the body of a patient. The array comprises a plurality of electrode microstructures which are inserted into the epidermis, thereby overcoming the inherent electrical impedance of the outer skin layers and obviating the need to prepare the skin surface prior to an electro-therapy treatment. The array preferably includes an adhesion layer to help keep the electrode microstructures inserted into the epidermis during the duration of the therapeutic treatment, and temperature and condition monitoring devices to ensure proper treatment and enhance patient safety.

Claims

1. A percutaneous electrode array for delivering therapeutic electrical energy to a patient, comprising:

an electrically conductive substrate having a top side and a bottom side; and

a plurality of electrodes each having a proximal end, a distal end, an axis from said proximal end to said distal end, and a length along said axis, wherein each electrode is attached to said top side of said substrate;

wherein said electrodes have a total surface area of more than 0.2 square centimeters; and

wherein said electrodes are electrically connected together by said substrate.

2. The array of claim 1, wherein the electrodes are substantially a cylinder and have a diameter of 20 to 250 micrometers.

3. The array of claim 1, wherein the electrodes are substantially a rectangular parallelepiped having a pair of narrow sides, a pair of wide sides, a top side and a bottom side, and wherein the wide sides have a width of 20 to 250 micrometers.

4. The array of claim 3, wherein the wide sides have a width of about 200 micrometers.

5. The array of claim 1, wherein the length of the electrodes is between 120 and 500 micrometers.

6. The array of claim 1, wherein the length of the electrodes is between 150 and 200 micrometers.

7. The array of claim 1, wherein the distal end of each electrode is one or more of thinned and pointed to facilitate placement into skin.

8. The array of claim 1, wherein the axis of the electrodes is perpendicular to the substrate.

9. The array of claim 1, wherein the axis of the electrodes is angled between perpendicular and parallel to the substrate.

10. The array of claim 1, wherein the substrate comprises a shape-memory metal alloy.

11. The array of claim 1, wherein the electrodes comprise one or more of doped semiconductor material, silicon-metal compound, stainless steel, conductive polymer, carbon allotrope, and a conductive metal either in bulk or deposited material.

12. The array of claim 1, further comprising a temperature element bonded to the substrate.

13. The array of claim 12, wherein the temperature element is one of a thermistor, a diode, a semiconductor junction, and a thermocouple.

14. The array of claim 1, further comprising an adhesion layer.

15. The array of claim 1, further comprising:

a plurality of voids that pass through the top side of the substrate to the bottom side; and

an adhesion layer comprising a bottom side, a top side, and a plurality of protrusions extending above the top side;

wherein the top side of the adhesion layer is attached to the bottom side of the substrate, and the protrusions pass through the voids to a first height above the top side of the substrate.

16. The array of claim 15, wherein the electrodes extend above the first height of the adhesion layer between 150 and 200 micrometers.

17. The array of claim 15, wherein the electrodes have a total surface area above the first height of the adhesion layer of at least 0.2 square centimeters.

18. The array of claim 15, wherein the adhesion layer comprises an electrically conductive hydrogel.

19. The array of claim 15, wherein the adhesion layer comprises a removable medical adhesive.

20. The array of claim 15, wherein the adhesion layer changes color as a function of ambient conditions.

21. The array of claim 15, further comprising a capacitive plate disposed on the bottom side of the adhesion layer and an electrically insulating layer disposed on the capacitive plate opposite the adhesion layer.

22. The array of claim 21, further comprising a temperature element embedded in the adhesion layer.

25. The array of claim 1, wherein

a temperature element is bonded to said substrate.

23. A percutaneous electrode array for delivering therapeutic electrical energy to a patient, comprising:

an electrically conductive substrate having a top side and a bottom side; and

a plurality of electrodes each having a proximal end, a distal end, an axis from said proximal end to said distal end, and a length along said axis;

wherein each electrode is attached to said top side of said substrate, said substrate has a surface area greater than 14.1 square millimeters and said electrodes have a total surface area of less than 0.2 square centimeters; and

wherein said electrodes are electrically connected together by said substrate.

24. An electrode for delivering therapeutic electrical energy to a patient, comprising:

a substrate having a first side and a second side;

an adhesion layer comprising a bottom side and a top side attached to the first side of the substrate;

a capacitive plate disposed on the bottom side of the adhesion layer; and

an electrically insulating layer disposed on the capacitive plate opposite the adhesion layer.