Shielded electrode for nerve sensing

• US 7,536,227 B1
• Filed: 01/26/2005
• Issued: 05/19/2009
• Est. Priority Date: 01/26/2005
• Status: Active Grant

• Current Assignee: Pacesetter Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Pacesetter Incorporated (Abbott Laboratories Incorporated)
• Inventors: Poore, John W., Bornzin, Gene A.
• Primary Examiner(s): Layno; Carl H
• Assistant Examiner(s): ANTHONY, JESSICA LYNN
• Application Number:
  US11/045,626
• Time in Patent Office: 1,574 Days
• Field of Search: 607115-118, 607 1- 3, 607 44- 46, 607 48- 49, 600372-373, 600377-378, 600/381, 600/345, 600 26- 28, 600386-393, 600546-548
• US Class Current: 607/118
• CPC Class Codes: A61B 2562/182 Electrical shielding, e.g. using a Faraday cage
• CPC Class Codes: A61B 5/053 Measuring electrical impedance or conductance of a portion of the body
• CPC Class Codes: A61B 5/0538 invasively, e.g. using a catheter
• CPC Class Codes: A61B 5/0809 by impedance pneumography
• CPC Class Codes: A61B 5/24 Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
• CPC Class Codes: A61B 5/6885 Monitoring or controlling sensor contact pressure
• CPC Class Codes: A61N 1/0556 Cuff electrodes

Abstract

A shielded electrode assembly for nerve sensing is disclosed. The electrode assembly is a flexible and generally tubular structure that can be wrapped around and secured to the outer surface of a nerve so as to establish and maintain electrical contact therewith. The assembly includes an electrically conductive shield with conductive reference electrodes positioned at opposite ends thereof to define an isopotential reference. A sense electrode is placed within the isopotential reference and senses signals either with respect to the isopotential reference or to a sense reference electrode also positioned within the isopotential reference to a sensing device. The isopotential reference provides a region along which nerve activity propagating along the nerve can be sensed with a large attenuation of any external noise which may be present adjacent the sensing region of the nerve. The shielded electrode assembly facilitates direct, long-term nerve sensing with reduced need for filtering or signal processing.

Claims

1. An electrode assembly for sensing nerve signals, the electrode assembly comprising:

an electrically conductive layer adapted to form an implantable shield assembly, extending circumferentially around at least a first portion of a nerve;

at least two reference electrodes electrically coupled to the shield assembly and extending circumferentially around the first portion of the nerve wherein the shield assembly and the reference electrodes are configured to contact a nerve so as to define a substantially isopotential reference; and

at least one implantable sense electrode configured to contact the nerve and positioned between the conductive layer of the shield assembly and the first portion of the nerve such that the sense electrode is electrically insulated from the shield assembly and at least partially shielded by the shield assembly from potentials arising externally to the nerve.

2. The electrode assembly of claim 1, wherein the reference electrodes are further configured to substantially circumferentially contact outer surfaces of the nerve and wherein the reference electrodes are connected at opposite ends to the shield assembly so as to define the isopotential reference as a generally cylindrical region bounded by the shield assembly and the one or more reference electrodes.

3. The electrode assembly of claim 1 further comprising a sense reference electrode configured to contact the nerve and positioned with respect to the shield assembly such that the sense reference electrode is also at least partially shielded by the shield assembly from potentials arising externally to the nerve such that the sense and sense reference electrode can sense signals propagated along the nerve with reduced influence of external electrical noise.

4. The electrode assembly of claim 1, further comprising:

a shield lead connected to the shield assembly; and

a sense lead connected to the sense electrode wherein the shield lead and sense lead are electrically insulated from each other and extend outwards from the shield assembly and sense electrode.

5. The electrode assembly of claim 1, wherein the electrode assembly is at least partly flexible and is configured such that the electrode assembly is wrappable about the nerve so as to extend substantially circumferentially about the outer surface of the nerve.

6. The electrode assembly of claim 5, further comprising securements securing the electrode assembly in place on the nerve.

7. The electrode assembly of claim 6, wherein the securements comprise sutures.

8. An implantable medical device comprising:

a processor; and

a shielded electrode assembly in communication with the processor, wherein the shielded electrode assembly comprises an implantable shield assembly having an electrically conductive layer extending circumferentially around at least a first portion of a nerve and at least two reference electrodes electrically coupled to the shield assembly and extending circumferentially around the first portion of a nerve wherein the shield assembly and the reference electrodes are configured to contact a nerve so as to define a substantially isopotential reference and at least one sense electrode which is electrically insulated from the shield assembly and positioned between the electrically conductive layer of the shield assembly and the first portion of the nerve and wherein the electrode assembly senses nerve activity in a manner that is at least partially shielded from electrical potentials arising external to the nerve.

9. The implantable medical device of claim 8, wherein the shielded electrode assembly further comprises:

at least one sense electrode configured to contact the nerve and positioned with respect to the shield assembly such that the sense electrode is shielded by the shield assembly from potentials arising externally to the nerve.

10. The implantable medical device of claim 9, further comprising a lead assembly conducting signals sensed by the sense electrode to the processor.

11. The implantable medical device of claim 8, further comprising:

a stimulation pulse generator; and

at least one implantable stimulation lead with at least one stimulation electrode configured to contact patient tissue such that the device can selectively provide therapeutic stimulation to the patient.

12. The implantable medical device of claim 11, wherein the device evaluates signals received from the shielded electrode assembly and delivers therapy based at least in part on the evaluation.

13. The implantable medical device of claim 12, wherein the shielded electrode assembly is configured to contact the phrenic nerve and wherein the device evaluates signals received from the shielded electrode assembly for indications of central sleep apnea and, upon determination that an episode of central sleep apnea has occurred, initiates a therapeutic treatment.

14. The implantable medical device of claim 13, wherein the therapeutic treatment comprises enabling an overdrive pacing regimen.

15. The implantable medical device of claim 8, further comprising at least one physiological sensor which senses at least one physiological parameter independently from the shielded electrode assembly.

16. The implantable medical device of claim 8, further comprising memory wherein the device stores data received from the shielded electrode assembly.

17. The implantable medical device of claim 8, further comprising a telemetry circuit such that the device can telemetrically transmit data relating to signals sensed by the shielded electrode assembly to an external device.