Electrode array and skin attachment system for noninvasive nerve location and imaging device

• US 6,564,079 B1
• Filed: 07/27/2000
• Issued: 05/13/2003
• Est. Priority Date: 07/27/2000
• Status: Expired due to Fees

• Current Assignee: Nervonix, Inc.
• Original Assignee: CKM Diagnostics, Inc.
• Inventors: Cory, Joan M., Cory, Philip C.
• Primary Examiner(s): Dvorak, Linda C. M.
• Assistant Examiner(s): Ruddy, David M.
• Application Number:
  US09/624,397
• Time in Patent Office: 1,020 Days
• Field of Search: 600/547, 600/548, 600/554, 600/557, 600/382, 600/386, 600/391, 600/393, 600/397, 600/395, 607/152, 607/46, 607/118, 335/12
• US Class Current: 600/393
• CPC Class Codes: A61B 2562/046 in a matrix array
• CPC Class Codes: A61B 5/0531 Measuring skin impedance
• CPC Class Codes: A61B 5/24 Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
• CPC Class Codes: A61B 5/282 Holders for multiple electrodes for introduction into the body A61B5/287
• CPC Class Codes: A61B 5/4893 Nerves

Abstract

A system for detecting and marking the positions of peripheral nerves is disclosed. A reusable electrode array comprising a plurality of electrodes is combined with a disposable skin attachment system comprising hydrogel islands. In use, the electrode array is connected to a peripheral nerve detection instrument. The disposable skin attachment system is then attached to an electrode sensor region. The skin attachment system is then adhered to an area of skin, detection is carried out, and then the electrode array is peeled back from the skin, leaving a skin marking guide in place. The skin marking guide is then used to mark areas of interest to a therapist.

Claims

1. An electrode array comprising:

a sheet of electrically non-conductive material having a sensor electrode region, an instrumentation connector region and a flexible stem region mechanically joining the sensor electrode region and the instrumentation connector region;

circuitry comprising an electrode array having at least two electrodes, which are disposed within the sensor electrode region,

a connection lead corresponding to each electrode disposed within the instrumentation connector region,

a negative return lead disposed within the instrumentation connector region,

an electrically conductive connection between each electrode and its corresponding connection lead; and

registration features on the sensor electrode region for a unique alignment with a skin attachment system.

2. An electrode array of claim 1, wherein the electrode array has 16 electrodes.

3. An electrode array of claim 1, wherein the electrode array has 64 electrodes.

4. An electrode array of claim 1, wherein the electrode array comprises at least four electrodes arranged in rows.

5. An electrode array of claim 4, wherein the sensor electrodes of each row are in line with the electrodes of the adjacent row or rows.

6. An electrode array of claim 5, wherein the electrode array comprises 64 electrodes arranged in 8 rows of 8 sensor electrodes each.

7. An electrode array of claim 4, wherein the sensor electrodes of each row are offset with respect to the sensor electrodes of the adjacent row or rows.

8. An electrode array of claim 7, wherein the sensor array has 16 electrodes arranged in two rows of 8 sensor electrodes each.

9. An electrode array of claim 1, wherein the sheet of electrically non-conductive material is a sheet of polyimide.

10. An electrode array of claim 1, wherein the sensor electrodes are gold-plated.

11. An electrode array of claim 1, wherein the sensor electrodes are connected to the connector leads by metal paste conductive traces, which are printed or silk-screened onto the electrically non-conductive sheet.

12. An electrode array of claim 1, wherein the circuitry further comprises integrated circuitry chips.

13. An electrode array of claim 1, further comprising metal paste reinforcement.

20. An electrode array of claim 1, wherein the electrode array contains electrodes having diameters of 2 mm to 3 mm.

21. An electrode array of claim 1, wherein the electrode array contain electrodes having an edge to edge spacing of about 3 mm.

14. A skin attachment system for attaching an electrode array to skin comprising:

at least one registration feature for alignment of the skin attachment system with an electrode array;

a skin marking guide layer, having at least two marking holes therein;

a support layer having one hydrogel island hole corresponding to each marking hole in the skin marking guide layer, each said hydrogel island hole containing a hydrogel island, which projects into its corresponding marking hole;

wherein the skin marking guide layer and the support layer are detachably affixed one to the other.

15. A skin attachment system of claim 14, further comprising a top cover layer adjacent to the top of the support layer, a fenestrated skin marking guide layer adjacent the bottom of the support layer and a bottom cover layer adjacent the fenestrated skin marking guide;

the top cover layer being detachably affixed to the support layer; and

the fenestrated skin marking guide layer being detachably affixed to the bottom cover layer and detachably affixed to the support layer;

so that the top cover layer and the bottom cover layer may be removed from the skin attachment system prior to using the skin attachment system for imaging peripheral nerves.

16. A sensor system for the imaging of peripheral nerves, comprising a skin attachment system, an electrode array and a medical imaging instrument,

said skin attachment system for attaching an electrode array to skin comprising:

at least one registration feature for alignment of the skin attachment system with an electrode array;

a skin marking guide layer, having at least two marking holes therein;

a support layer having one hydrogel island hole corresponding to each marking hole in the skin marking guide layer, each said hydrogel island hole containing a hydrogel island, which projects into its corresponding marking hole;

wherein the skin marking guide layer and the support layer are detachably affixed one to the other; and

said electrode array comprising;

a sheet of electrically non-conductive material having a sensor electrode region, an instrumentation connector region and a flexible stem region mechanically joining the electrode sensor region and the instrumentation connector region;

circuitry comprising an electrode array having at least two electrodes, which are disposed within the sensor electrode region,

a connection lead corresponding to each electrode disposed within the instrumentation connector region,

a negative return lead disposed within the instrumentation connector region,

an electrically conductive connection between each electrode and its corresponding connection lead; and

registration features on the sensor electrode region for alignment with a skin attachment system.

17. A sensor system of claim 16, further wherein

the skin attachment system further comprises a top cover layer adjacent to the support layer, a fenestrated skin marking guide layer adjacent to the support layer and a bottom cover layer adjacent to the fenestrated skin marking guide layer;

the top cover layer being detachably affixed to the support layer; and

the fenestrated skin marking guide layer being detachably affixed to the bottom cover layer and detachably affixed to the support layer;

so that the top cover layer and the bottom cover layer may be removed from the skin attachment system prior using the skin attachment system for imaging peripheral nerves.

18. A method of using a sensor system of claim 16, comprising

connecting the electrode array to a medical imaging instrument;

lining up the registration features of the skin attachment system with those of the electrode array and connecting the skin attachment system to the electrode array;

attaching the skin attachment system to skin;

attaching the negative return lead to skin.

19. A method of claim 18, further comprising removing the support layer and hydrogel islands from the skin marking guide layer, leaving the latter attached to the skin as a skin marking guide;

marking the skin through the marking holes of the skin marking guide or leaving the skin marking guide in place as a template for directing the position of at least one needle.