Electrode devices for nerve stimulation and cardiac sensing

• US 8,615,294 B2
• Filed: 08/13/2008
• Issued: 12/24/2013
• Est. Priority Date: 08/13/2008
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: BioControl Medical (B.C.M) Ltd.
• Inventors: Ben-David, Tamir, Ayal, Shai, Cohen, Ehud, Gross, Yossi, Schain, Nir
• Primary Examiner(s): Manuel, George
• Assistant Examiner(s): PHAM, MINH DUC GIA
• Application Number:
  US12/228,630
• Publication Number:
  US 20100042186A1
• Time in Patent Office: 1,959 Days
• Field of Search: 607/2, 607/3, 607/17, 607/18
• US Class Current: 607/2
• CPC Class Codes: A61B 5/24 Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
• CPC Class Codes: A61B 5/4041 Evaluating nerves condition
• CPC Class Codes: A61B 5/6846 specially adapted to be brought in contact with an internal body part, i.e. invasive
• CPC Class Codes: A61N 1/0556 Cuff electrodes
• CPC Class Codes: A61N 1/36114 Cardiac control, e.g. by vagal stimulation stimulating the heart A61N1/362

Abstract

Apparatus is provided for application to a nerve of a subject, the apparatus comprising an electrode device, which comprises a housing, which is configured to be placed at least partially around the nerve, so as to define an outer surface of the electrode device and an inner surface that faces the nerve. The electrode device further comprises one or more first electrode contact surfaces, fixed to the inner surface of the housing, and one or more second electrode contact surfaces, fixed to the outer surface of the housing. Other embodiments are also described.

Claims

1. Apparatus comprising:

an electrode cuff, which comprises;

a housing, which is configured to be placed around a nerve of a subject at a first location neither within nor in contact with a heart of the subject; and

one or more cuff first electrode contact surfaces, which are fixed to the housing;

at least one second electrode contact surface, which is not directly mechanically coupled to the electrode cuff, and which is configured to be positioned in a body of the subject at a second location neither within nor in contact with the heart; and

a control unit, which comprises;

a sensing unit, which is configured to sense, using (a) at least one of the cuff first electrode contact surfaces and (b) the at least one second electrode contact surface, an electrical signal between (a) the at least one of the cuff first electrode contact surfaces and (b) the at least one second electrode contact surface; and

an analysis unit, which is configured to analyze the signal to identify a parameter of a cardiac cycle of the subject.

2. The apparatus according to claim 1, wherein the at least one second electrode contact surface is directly mechanically coupled to the control unit.

3. The apparatus according to claim 1, wherein the control unit comprises a metal can having an outer conductive surface, at least a portion of which serves as the at least one second electrode contact surface.

4. The apparatus according to claim 1, wherein the housing, when placed around the nerve, is shaped so as to define an outer surface of the electrode cuff and an inner surface that faces the nerve, and wherein the one or more cuff first electrode contact surfaces are fixed to the inner surface of the housing.

5. The apparatus according to claim 1, wherein the housing, when placed around the nerve, is shaped so as to define an outer surface of the electrode cuff and an inner surface that faces the nerve, and wherein the one or more cuff first electrode contact surfaces are fixed to the outer surface of the housing.

6. The apparatus according to claim 1, wherein the nerve is the vagus nerve, and wherein the housing is configured to be placed around the vagus nerve.

7. The apparatus according to claim 1, wherein the control unit comprises a driving unit, which is configured to drive at least some of the cuff first electrode contact surfaces to apply electrical stimulation to the nerve, and configure the stimulation responsively to the parameter of the cardiac cycle.

8. The apparatus according to claim 7,

wherein the cuff first electrode contact surfaces comprise one or more stimulating cuff first electrode contact surfaces and one or more sensing stimulating cuff first electrode contact surfaces,

wherein the driving unit is configured to drive the stimulating cuff first electrode contact surfaces, and not the sensing stimulating cuff first electrode contact surfaces, to apply the stimulation, and

wherein the sensing unit is configured to sense the electrical signal using the sensing cuff first electrode contact surfaces, and not using the stimulating cuff first electrode contact surfaces.

9. The apparatus according to claim 7, wherein the parameter of the cardiac cycle is indicative of ventricular contraction, and wherein the driving unit is configured to drive the at least some of the cuff first electrode contact surfaces to apply the stimulation during at least one heart beat after a delay from the ventricular contraction, the delay having a duration of at least 20 ms.

10. The apparatus according to claim 1, further comprising at least one lead coupled to the control unit, wherein the at least one second electrode contact surface is directly mechanically coupled to the lead.

11. The apparatus according to claim 10, wherein the at least one lead couples the electrode cuff to the control unit, and wherein the at least one second electrode contact surface is directly mechanically coupled to the lead at a position between the electrode cuff and the control unit.

17. The apparatus according to claim 1, wherein the analysis unit is configured to identify one or more components of an electrocardiogram (ECG) of the heart.

21. The apparatus according to claim 4,

wherein the housing, when placed around the nerve, is shaped so as to further define two end insulating elements at respective longitudinal positions along the housing, which end insulating elements protrude from the inner surface of the housing toward the nerve so as to electrically isolate a portion of the nerve within the electrode cuff from a portion of the nerve outside the electrode cuff, and

wherein the one or more cuff first electrode contact surfaces are fixed to the inner surface of the housing longitudinally between the two end insulating elements.

12. A method comprising:

placing a housing of an electrode cuff around a nerve of a subject at a first location neither within nor in contact with a heart of the subject; and

implanting a control unit configured to sense, between the electrode cuff and a second location within a body of the subject neither within nor in contact with the heart, a signal indicative of a parameter of a cardiac cycle of the subject, using (a) at least one cuff first electrode contact surface fixed to a housing of the electrode cuff and (b) at least one second electrode contact surface at the second location.

13. The method according to claim 12, wherein sensing comprises sensing using an implanted control unit, and wherein the second location is at the control unit.

14. The method according to claim 12, wherein the nerve is a vagus nerve, and wherein placing comprises placing the housing of the electrode cuff around the vagus nerve.

15. The method according to claim 12, wherein placing the housing of the electrode device comprises placing the housing around the nerve, so as to define an outer surface of the electrode cuff and an inner surface that faces the nerve, and wherein sensing comprises sensing using at least one electrode contact surface that is fixed to the inner surface of the housing.

16. The method according to claim 12, wherein placing the housing of the electrode device comprises placing the housing around the nerve, so as to define an outer surface of the electrode cuff and an inner surface that faces the nerve, and wherein sensing comprises sensing using at least one electrode contact surface that is fixed to the outer surface of the housing.

18. The method according to claim 12, wherein implanting the control unit comprises implanting the control unit that is configured to sense one or more components of an electrocardiogram (ECG) of the heart.

19. The method according to claim 12, wherein implanting the control unit comprises implanting at least one lead that couples the electrode cuff to the control unit, and wherein the at least one second electrode contact surface is directly mechanically coupled to the lead at a position between the electrode cuff and the control unit.

20. The method according to claim 15,

wherein placing the housing around the nerve comprises placing the housing around the nerve, so as to define the outer surface of the electrode cuff and the inner surface that faces the nerve, and two end insulating elements at respective longitudinal positions along the housing, which end insulating elements protrude from the inner surface of the housing toward the nerve so as to electrically isolate a portion of the nerve within the electrode cuff from a portion of the nerve outside the electrode cuff, and

wherein sensing comprises sensing using the at least one electrode contact surface that is fixed to the inner surface of the housing longitudinally between the two end insulating elements.