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

• US 6,609,018 B2
• Filed: 07/26/2001
• Issued: 08/19/2003
• 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): Gibson, Roy D.
• Assistant Examiner(s): Vrettakos, Peter J
• Application Number:
  US09/912,535
• Publication Number:
  US 20020095080A1
• Time in Patent Office: 754 Days
• Field of Search: 600/393, 600/382, 600/372, 600/375, 600/384, 600/386, 600/391, 600/394, 600/395
• 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 disposable or reusable electrode array comprising a plurality of electrodes is combined with a disposable sensor attachment system comprising conductor islands. In use, the electrode array is connected to a peripheral nerve detection instrument. The disposable sensor attachment system is attached to an electrode sensor region. The sensor 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. A method of using a sensor system comprising a sensor attachment system, an electrode array, a return lead, and a medical imaging instrument, comprising the steps of:

connecting the electrode array to a medical imaging instrument;

lining up registration features contained on the sensor attachment system with registration features contained on the electrode array and connecting the sensor attachment system to the electrode array;

attaching the sensor attachment system to skin;

attaching the return lead to skin.

2. A method of using a sensor system comprising

comprising an electrode array and a medical imaging instrument, 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 sensor electrode region and the instrumentation connector region;

circuitry comprising an electrode array having one or more electrodes, which are disposed within the sensor electrode region,

at least one connection lead, each connection lead corresponding to at least one electrode disposed within the instrumentation connector region, and

at least one return lead disposed within the instrumentation connector region, each return lead corresponding to an electrode and a connection lead, and being operable to connect said connection lead with the corresponding electrode, comprising the steps of;

connecting the electrode array to a medical imaging instrument;

coating each electrode with an electrically conductive aqueous gel;

placing the electrode array on a body surface; and

attaching the return lead(s) to skin.

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

said sensor attachment system comprising:

at least one registration feature for alignment of the sensor attachment system with an electrode array,

a skin marking guide layer, having at least one marking hole therein;

a support layer having one conductor island hole corresponding to each marking hole in the skin marking guide layer, each said conductor island hole containing a conductor 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 sensor electrode region and the instrumentation connector region;

circuitry comprising an electrode array having one or more electrodes, which are disposed within the sensor electrode region,

at least one connection lead, each connection lead corresponding to at least one electrode disposed within the instrumentation connector region,

at least one return lead disposed within the instrumentation connector region, each return lead corresponding to an electrode and a connection lead, and operable to connect said connection lead with the corresponding electrode,

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

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

4. The sensor system of claim 3, wherein the registration feature may be a hole, notch, mark, shape or colored region.

5. The sensor system of claim 4, wherein the skin marking guide layer comprises at least one of polyurethane, polyethylene, polypropylene, polyvinyl chloride, and copolymers thereof.

6. The sensor system of claim 3, wherein the support layer is comprised of at least one of polyethylene, polypropylene, polyurethane, polyvinyl chloride, silastic and copolymers thereof.

7. The sensor system of claim 3, wherein the support layer is comprised of a closed-cell foam.

8. The sensor system of claim 3, wherein the support layer is comprised of an open-cell foam.

9. The sensor system of claim 3, wherein the conductor island is comprised of at least one of silver—

silver chloride gel or hydrogel.

10. The sensor system of claim 3, wherein the sheet of electrically non-conductive material comprises at least one of polyimide, vinyl, polyvinyl chloride, silastic, polyethylene, polyurethane and polycarbonate.

11. The sensor system of claim 3, wherein the electrodes contain at least one of a gold-plating, nickel-plating, platinum, palladium, metal—

metal salt combinations including silver—

silver chloride, or a conductive polymer.

12. The sensor system of claim 3, wherein the electrodes are connected to the connection leads by at least one of metal paste conductive traces, metallic ink metallic wire, and conductive polymer.

13. The sensor system of claim 3, wherein each connection lead corresponds to only one electrode disposed within the instrumentation connector region.

14. The sensor system of claim 3, further comprising integrated circuitry chips connected to the connection leads and being operable to connect a plurality of connection leads to a single connection lead.

15. The sensor system of claim 3, wherein said electrodes are supported by metal paste reinforcement.

16. The sensor system of claim 3, wherein said return lead corresponds to a return electrode disposed within the sensor electrode region of the electrode array.

17. The sensor system of claim 3, wherein said return lead corresponds to a return electrode that is separated from the sensor electrode region of the electrode array.

18. The sensor system of claim 3, wherein said return lead corresponds to a return electrode that is separate from the electrode sensor region of the electrode array, and said electrode is comprised of at least one of a hydro gel-containing electrode, a silver—

silver chloride gel electrode, a cup electrode that is filled with conductive gel, or a needle electrode.