Electrode structures and methods for their use in cardiovascular reflex control

• US 7,499,742 B2
• Filed: 03/27/2003
• Issued: 03/03/2009
• Est. Priority Date: 09/26/2001
• Status: Expired due to Term

• Current Assignee: CVRx, Inc.
• Original Assignee: CVRx, Inc.
• Inventors: Bolea, Stephen L., Keith, Peter T., Serdar, David J., Persson, Bruce J., Rossing, Martin A., Kieval, Robert S., Irwin, Eric D.
• Primary Examiner(s): Manuel; George
• Assistant Examiner(s): Flory; Christopher A
• Application Number:
  US10/402,911
• Publication Number:
  US 20040010303A1
• Time in Patent Office: 2,168 Days
• Field of Search: 607/118, 607/44, 607/117, 607/2, 607/6, 607/9, 128/784, 600/372, 600/373, 600/377, 600/381
• US Class Current: 600/372
• CPC Class Codes: A61B 5/02028 Determining haemodynamic parameters not otherwise provided for, e.g. cardiac contractility or left ventricular ejection fraction
• CPC Class Codes: A61N 1/05 for implantation or insertion into the body, e.g. heart electrode A61N1/06 takes precedence
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/056 Transvascular endocardial electrode systems
• CPC Class Codes: A61N 1/36053 adapted for vagal stimulation A61N1/36114 takes precedence
• CPC Class Codes: A61N 1/3611 Respiration control stimulating respiratory organs A61N1/3601
• CPC Class Codes: A61N 1/36114 Cardiac control, e.g. by vagal stimulation stimulating the heart A61N1/362
• CPC Class Codes: A61N 1/36117 for treating hypertension
• CPC Class Codes: A61N 1/36125 Details of circuitry or electric components
• CPC Class Codes: A61N 1/36135 using physiological parameters
• CPC Class Codes: A61N 1/36185 Selection of the electrode configuration
• CPC Class Codes: A61N 1/3702 Physiological parameters A61N1/365 takes precedence; evoked response A61N1/371

Abstract

Devices, systems and methods are described by which the blood pressure, nervous system activity, and neurohormonal activity may be selectively and controllably reduced by activating baroreceptors. A baroreceptor activation device is positioned near a baroreceptor, preferably a baroreceptor located in the carotid sinus. A control system may be used to modulate the baroreceptor activation device. The control system may utilize an algorithm defining a stimulus regimen which promotes long term efficacy and reduces power requirements/consumption. The baroreceptor activation device may utilize electrodes to activate the baroreceptors. The electrodes may be adapted for connection to the carotid arteries at or near the carotid sinus, and may be designed to minimize extraneous tissue stimulation.

Claims

1. A device for mounting over a circumference of a carotid sinus of a patient, the device comprising:

a base having first and second ends, a longitudinal axis therebetween, and an axial length sufficient to extend around the circumference of the carotid sinus, wherein said base is sufficiently elastic to conform to said circumference as the carotid sinus changes in shape and size with heart pulse;

an axial attachment tab extending in the axial direction from an end of the base;

a transversely angled attachment tab extending transversely from an end of the base at an acute angle relative to the longitudinal axis of the base when the base is in an unstressed configuration prior to placement about the carotid sinus; and

one or more elongate electrodes connected to the base;

wherein either or both of the axial attachment tab and the transversely angled attachment tab may be wrapped around the carotid sinus or the internal carotid artery and attached to the base or blood vessel to accommodate the shape of the carotid sinus.

2. A device as in claim 1, comprising two or more electrodes positioned circumferentially and adjacent each other on the base.

3. A device as in claim 1, wherein the electrodes extend less than 75% of the length of the base.

4. A device as in claim 1, wherein the electrodes extend less than 50% of the length of the base.

5. A device as in claim 1, wherein the electrodes extend less than 25% of the length of the base.

6. A device as in claim 1, wherein the elastic base comprises an elastomeric sheet.

7. A device as in claim 6, wherein the elastomeric sheet comprises an elastomer selected from the group consisting of silicone, polyurethane, and latex.

8. A device as in claim 1, further comprising a pair of axial attachment tabs and a pair of transversely angled attachment tabs, wherein both of the transversely angled attachment tabs extend from the base at acute angles relative to the exis of the base and wherein one axial and one transversely angled attachment tab are attached at one corner of one end and another axial and another transversely angled attachment tab are attached at the other corner of the one end.

9. A device as in claim 1, wherein the electrodes comprise coils in which the individual turns of the coil are flattened in a plane parallel to that of the elastic base.

10. An extravascular electrode assembly comprising:

a base adapted to be attached over the outside of a blood vessel, said base having an electrode-carrying surface and at least four attachment tabs extending away from the electrode-carrying surface, wherein the base has a longitudinal axis and is sufficiently elastic to conform to a circumference of a blood vessel and wherein at least two tabs are axially aligned with the longitudinal axis of the base and at least two tabs are angled acutely relative to the longitudinal axis when the base is in an unstressed configuration prior to placement around the blood vessel to permit selective ones of the tabs to be wrapped around the blood vessel while others of the tabs are removed; and

an electrode structure on the electrode-carrying surface.

11. An electrode assembly as in claim 10, wherein the electrode-carrying surface is rectangular and the at least two axially aligned tabs extend from adjacent corners of the surface, wherein the two acutely transversely angled tabs extend from the same corners.

12. An electrode assembly as in claim 10, wherein individual turns of the elongate coil electrode are flattened in a plane parallel to that of the elastic backing.

13. An electrode assembly as in claim 10, wherein the elastic base comprises an elastomeric sheet.

14. An electrode assembly as in claim 13, wherein the elastomeric sheet comprise an elastomer selected from the group consisting of silicone, polyurethane, and latex.

15. An electrode assembly as in claim 10, comprising two or more electrodes positioned circumferentially and adjacent each other on the base.

16. An electrode assembly as in claim 10, wherein the electrodes extend less than 75% of the length of the base.

17. An electrode assembly as in claim 10, wherein the electrodes extend less than 50% of the length of the base.

18. An electrode assembly as in claim 10, wherein the electrodes extend less than 25% of the length of the base.

19. An electrode assembly as in claim 10, wherein the base has first and second ends, and wherein the ends are adapted to be joined.

20. A method for wrapping an electrode assembly over carotid sinus, said method comprising:

providing an electrode assembly comprising an elastic base having a longitudinal axis, a plurality of attachment tabs including at least two tabs aligned axially with the longitudinal axis of the base and two tabs attached to the base at an acute angle relative to the longitudinal axis, and at least one electrode sufficiently stretchable to stretch with expansions and contractions of the the carotid sinus with heart pulse secured over a surface of the elastic base;

conforming the base over an exterior of the carotid sinus, wherein at least a portion of the electrode assembly can flex and stretch with expansions and contractions of the carotid sinus with heart pulse; and

securing ends of the elastic base together and!or to the vessel wall to hold the electrode assembly in place, wherein securing said ends includes wrapping at least two one of said plurality of tabs around the carotid sinus and cutting off the remaining tabs which are not wrapped around the carotid sinus.

21. A method as in claim 20, wherein conforming comprises locating the at least one electrode over a target site in the carotid sinus.

22. A method as in claim 21, wherein the target site comprises excitable tissue.

23. A method as in claim 22, wherein the excitable tissue comprises baroreceptors in a wall of the the carotid sinus.

24. A method as in claim 20, wherein conforming the base comprises covering a circumferential distance around the the carotid sinus equal to at least 25% of the circumference of the blood vessel exterior.

25. A method as in claim 24, wherein conforming the base comprises covering a circumferential distance around the the carotid sinus equal to at least 50% of the circumference of the the carotid sinus exterior.

26. A method as in claim 24, wherein conforming the base comprises covering a circumferential distance around the the carotid sinus equal to at least 66% of the circumference of the blood vessel exterior.

27. A method as in claim 24, wherein conforming the base comprises covering a circumferential distance around the the carotid sinus equal to at least 75% of the circumference of the the carotid sinus exterior.

28. A method as in claim 24, wherein the base is conformed over the entire circumference of the the carotid sinus exterior.

29. A method as in claim 20, further comprising wrapping at least one tab around an internal carotid artery.

30. A method as in claim 29, wherein at least one axially aligned tab is wrapped around the common carotid artery and at least one acutely transversely angled tab is wrapped around the internal carotid artery.