Transvascular neural stimulation device

• US 7,499,748 B2
• Filed: 04/11/2005
• Issued: 03/03/2009
• Est. Priority Date: 04/11/2005
• Status: Active Grant

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Moffitt, Julia, Libbus, Imad
• Primary Examiner(s): SCHAETZLE, KENNEDY
• Application Number:
  US11/103,245
• Publication Number:
  US 20060229677A1
• Time in Patent Office: 1,422 Days
• Field of Search: None
• US Class Current: 607/9
• CPC Class Codes: A61M 31/00 Devices for introducing or retaining media, e.g. remedies, in cavities of the body A61M25/00 takes precedence ; introducing or retaining ophthalmic products into the ocular cavities A61F9/0008
• CPC Class Codes: A61N 1/0558 Anchoring or fixation means therefor
• 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 1/3627 for treating a mechanical deficiency of the heart, e.g. congestive heart failure or cardiomyopathy
• CPC Class Codes: A61N 1/3629 in combination with non-electric therapy
• CPC Class Codes: A61N 1/37217 characterised by the communication link, e.g. acoustic or tactile
• CPC Class Codes: A61N 1/37288 Communication to several implantable medical devices within one patient

Abstract

This document discusses, among other things, apparatus, systems, and methods for transvascularly stimulation of a nerve or nerve trunk. In an example, an apparatus is configured to transvascularly stimulate a nerve trunk through a blood vessel. The apparatus includes an expandable electrode that is chronically implantable in a blood vessel proximate a nerve trunk. The expandable electrode is configured to abut a predetermined surface area of the vessel wall along a predetermined length of the vessel. An electrical lead is coupled to the expandable electrode. An implantable pulse generator is coupled to the lead and configured to deliver an electrical stimulation signal to the electrode through the lead. In an example method, an electrical signal is delivered from an implanted medical device to an electrode chronically implanted in a blood vessel proximate a nerve trunk to transvascularly deliver neural stimulation from the electrode to the nerve trunk.

Claims

1. An implantable apparatus for transvasculary stimulating a vagus nerve trunk in a cervical region from an internal jugular vein (IJV) to provide a therapy to inhibit heart failure remodeling, the apparatus comprising:

an expandable electrode chronically implantable in the IJV, the expandable electrode configured to abut an intravascular surface of the IJV in the cervical region proximate the vagus nerve trunk;

an electrical lead coupled to the expandable electrode, the electrical lead adapted to be intravascularly fed into the IJV;

an implantable pulse generator coupled to the lead and configured to deliver an electrical stimulation signal to the electrode through the lead, wherein the apparatus is configured to transvascularly stimulate the vagus nerve trunk from the IJV; and

a controller adapted to control the pulse generator to deliver a programmable electrical pulse therapy to inhibit heart failure remodeling, wherein the therapy to inhibit heart failure remodeling includes stimulating to the vagus nerve in the cervical region.

2. The apparatus of claim 1, wherein the expandable electrode is configured to abut a predetermined surface area of a wall of the IJV along a predetermined length of the IJV.

3. The apparatus of claim 2, wherein the predetermined length is about 1 centimeter.

4. The apparatus of claim 3, wherein the expandable electrode has an expanded diameter is about 0.5 to 1.5 cm.

5. The apparatus of claim 2, wherein the predetermined surface area is about 0.25 to 5 cm².

6. The apparatus of claim 5, wherein the expandable electrode has a length about 0.5 to 2.0 cm.

7. The system of claim 5, wherein the expandable electrode has a length about 0.5 to 2.0 cm, a predetermined surface area to touch a wall of the IJV of about 0.25 to 5 cm², and an expanded diameter of about 0.5 to 1.5 cm.

8. The system of claim 5, further comprising a right ventricle lead and a left ventricle lead, wherein the system is adapted to capture myocardial tissue using the right ventricle lead and the left ventricle lead, and the system is adapted to deliver cardiac resynchronization therapy using the left and right ventricle leads.

9. The system of claim 5, further comprising at least one of a right ventricle lead or a left ventricle lead, wherein the system is adapted to pace the right or left ventricle using the right ventricle lead or the left ventricle lead.

10. The apparatus of claim 1, wherein the expandable electrode includes a mesh, at least part of the mesh being conductive.

11. The apparatus of claim 10, wherein the expandable electrode has a surface area to touch a wall of the IJV, and all of the surface area is conductive.

12. The apparatus of claim 10, wherein the expandable electrode has a surface area to touch a wall of the IJV, and some of the surface area is non-conductive.

13. The apparatus of claim 1, wherein the expandable electrode includes a drug-eluting component that is configured to be implanted inside the IJV.

14. The apparatus of claim 13, wherein the drug-eluting component is adapted to elute a drug to prevent occlusion.

15. The apparatus of claim 13, wherein the drug-eluting component is adapted to elute a drug to reduce inflammation.

16. The apparatus of claim 1, wherein the expandable electrode included platinum or platinum-iridium.

17. The apparatus of claim 1, further comprising a right ventricle lead and a left ventricle lead, wherein the apparatus is adapted to capture myocardial tissue using the right ventricle lead and the left ventricle lead, and the apparatus is adapted to deliver cardiac resynchronization therapy using the left and right ventricle leads.

18. The apparatus of claim 1, further comprising at least one of a right ventricle lead or a left ventricle lead, wherein the apparatus is adapted to pace the right or left ventricle using the right ventricle lead or the left ventricle lead.

19. A system for transvasculary stimulating a vagus nerve trunk in a cervical region from an internal jugular vein (IJV) to provide a therapy to inhibit heart failure remodeling, the system comprising:

an expandable electrode implantable in the IJV in the cervical region proximate the vagus nerve trunk;

a lead assembly coupled to the expandable electrode, the lead assembly including an electrical lead adapted to be intravascularly fed into the IJV; and

an implantable device coupled to the lead assembly, the implantable device including a controller circuit to communicate with a neural stimulator, a telemetry circuit to communicate with the controller circuit and an external module, a memory circuit to communicate with the controller circuit, and computer-readable instructions embedded in the memory circuit, the computer-readable instructions being operable on by the controller to deliver a programmable electric pulse therapy from the neural stimulator through the expandable electrode to the vagus nerve trunk to inhibit cardiac remodeling from heart failure.

20. The system of claim 19, wherein the expandable electrode includes a stent.

21. The system of claim 19, wherein the expandable electrode has a length about 0.5 to 2.0 cm, a predetermined surface area to touch a wall of the IJV of about 0.25 to 5 cm², and an expanded diameter of about 0.5 to 1.5 cm.

22. The system of claim 19, further comprising a right ventricle lead and a left ventricle lead, wherein the system is adapted to capture myocardial tissue using the right ventricle lead and the left ventricle lead, and the system is adapted to deliver cardiac resynchronization therapy using the left and right ventricle leads.

23. The system of claim 19, further comprising at least one of a right ventricle lead or a left ventricle lead, wherein the system is adapted to pace the right or left ventricle using the right ventricle lead or the left ventricle lead.

24. A system for transvasculary stimulating a vagus nerve trunk in a cervical region from an internal jugular vein (IJV) in a cervical region to provide a therapy to inhibit heart failure remodeling, the system comprising:

an expandable electrode implantable in the IJV within the cervical region proximate the vagus nerve trunk;

a lead assembly coupled to the expandable electrode, the lead assembly including an electrical lead adapted to be intravascularly fed into the IJV; and

an implantable device coupled to the lead assembly, the implantable device including a controller circuit to communicate with a neural stimulator, a telemetry circuit to communicate with the controller circuit and an external module, a memory circuit to communicate with the controller circuit, and computer-readable instructions embedded in the memory circuit, the computer-readable instructions being operable on by the controller to deliver a programmable electric pulse therapy to inhibit heart failure remodeling, where the therapy is delivered from the neural stimulator through the expandable electrode to depolarize the vagus nerve trunk in the cervical region.

25. The system of claim 24, wherein the instructions are further operable on the controller to transvascularly stimulate the vagus nerve trunk to deliver antiarrhythmia therapy following myocardial infarction.

26. The system of claim 24, wherein:

the expandable electrode is configured to abut a predetermined surface area of the internal jugular vein along about 1 centimeter of the IJV, the expandable electrode having an expanded diameter dimensioned and configured to fix the electrode in place in the blood vessel by frictional forces; and

the expandable electrode includes a mesh, at least part of the mesh being conductive.

27. The system of claim 26, wherein the expandable electrode includes a drug-eluting coating that prevents inflammation of stimulated tissue.

28. The system of claim 24, wherein the programmable electric pulse therapy includes an approximately 20 hertz pulse train.