TECHNIQUES FOR PLACING MEDICAL LEADS FOR ELECTRICAL STIMULATION OF NERVE TISSUE

• US 20090275996A1
• Filed: 04/30/2009
• Published: 11/05/2009
• Est. Priority Date: 04/30/2008
• Status: Abandoned Application

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Scheiner, Avram, Warman, Eduardo N., Bonner, Matthew D., Burnes, John E., Musley, Shailesh Kumar V.
• Application Number:
  US12/433,770
• Publication Number:
  US 20090275996A1
• Time in Patent Office: Days
• US Class Current: 607/2
• CPC Class Codes: A61M 25/09 Guide wires
• 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 1/0558 Anchoring or fixation means therefor
• CPC Class Codes: A61N 1/057 Anchoring means; Means for fixing the head inside the heart
• CPC Class Codes: A61N 1/36053 adapted for vagal stimulation A61N1/36114 takes precedence
• CPC Class Codes: A61N 1/36085 Eating disorders or obesity
• CPC Class Codes: A61N 1/36114 Cardiac control, e.g. by vagal stimulation stimulating the heart A61N1/362
• CPC Class Codes: A61N 1/36125 Details of circuitry or electric components
• CPC Class Codes: A61N 1/36128 Control systems

Abstract

This disclosure is directed to extra, intra, and transvascular medical lead placement techniques for arranging medical leads and electrical stimulation and/or sensing electrodes proximate nerve tissue within a patient.

Claims

1. An implantable medical system configured to deliver electrical stimulation from within a lumen of a blood vessel within a patient to nerve tissue located adjacent to and outside of the blood vessel, the system comprising:

a generally cylindrical expandable and contractible lead member arranged within the blood vessel lumen relative to the nerve tissue; and

a plurality of electrodes connected to the lead member;

wherein the lead member is temporarily deployable for testing multiple combinations of the plurality of electrodes before deploying the lead member for chronic therapy of the patient.

2. The system of claim 1, wherein the electrodes are arranged on an exterior surface of the lead member in one or more columns substantially parallel to a longitudinal axis of the lead member.

3. The system of claim 1, wherein the electrodes are arranged on an exterior surface of the lead member in one or more columns oriented at an angle with respect to a longitudinal axis of the lead member.

4. The system of claim 1, wherein the lead member comprises a helical structure with the plurality of electrodes on the helical structure.

5. The system of claim 4, wherein the electrodes are arranged on an exterior of the helical structure in one or more columns generally parallel to a trajectory of the helical ribbon.

6. The system of claim 4, wherein the helical structure is expandable in a transverse direction relative to a longitudinal axis of the lead member by bringing two ends of the lead member closer to one another and contractible in the transverse direction by pulling the two ends of the lead member away from each other.

7. The system of claim 1, wherein the helical structure comprises one of a helical ribbon or an elongated substantially cylindrical helical structure.

8. The system of claim 1, wherein the lead member comprises a stent.

9. The system of claim 8, wherein the stent lead member comprises a mesh of material segments each of which is pivotally joined at either end to another segment at a vertex to form a plurality of polygons.

10. The system of claim 9, wherein the mesh stent lead member is expandable and contractible by rotation of the material segments with respect to each other at the plurality of vertices at which the segments are pivotally joined.

11. The system of claim 9, wherein the electrodes are arranged at a plurality of the vertices pivotally joining the material segments forming the mesh stent lead member.

12. The system of claim 8, wherein the stent lead member comprises a drug-eluting layer configured to interact with tissue of the blood vessel.

13. The system of claim 1 further comprising a catheter configured to hold the lead member in an at least partially contracted state.

14. The system of claim 13, wherein the catheter comprises a lumen in which the lead member is arranged and including one or more apertures arranged over one or more of the plurality of electrodes connected to the lead member.

15. The system of claim 1, wherein the nerve tissue comprises one of a vagus nerve, a hypoglossal nerve, a nerve plexus, nerve ganglia, or a vascular baroreceptors.

16. A method comprising:

arranging a generally cylindrical expandable and contractible lead member within a lumen of a blood vessel adjacent target nerve tissue;

temporarily deploying the cylindrical lead member within the lumen relative to the nerve tissue;

energizing one or more electrodes connected to the cylindrical lead member to deliver electrical stimulation from within the blood vessel lumen to the nerve tissue; and

chronically deploying the cylindrical lead member in an expanded state within the lumen relative to the nerve tissue.

17. The method of claim 16 further comprising determining an efficacy of the nerve tissue stimulation.

18. The method of claim 17 further comprising:

comparing the efficacy of the nerve tissue stimulation to a threshold efficacy; and

redeploying the cylindrical lead member within the lumen relative to the nerve tissue, if the efficacy of the nerve tissue stimulation does not meet or exceed the threshold efficacy.

19. The method of claim 18, wherein, if the efficacy of the nerve tissue stimulation does not meet or exceed the threshold efficacy, then further comprising:

energizing one or more electrodes connected to the redeployed cylindrical lead member to deliver electrical stimulation from within the blood vessel lumen to the nerve tissue; and

determining if an efficacy of the electrical stimulation delivered by the redeployed cylindrical lead member meets or exceeds the threshold efficacy.

20. The method of claim 16, wherein deploying the cylindrical lead member within the lumen relative to the nerve tissue comprises:

orienting the electrodes connected to the cylindrical lead member within the lumen relative to the nerve tissue; and

selecting one or more combinations of the plurality of electrodes to deliver electrical stimulation from within the blood vessel lumen to the nerve tissue.

21. The method of claim 20, wherein deploying the cylindrical lead member within the lumen relative to the nerve tissue further comprises expanding the cylindrical lead member.

22. The method of claim 16, wherein the nerve tissue comprises one of a vagus nerve, a hypoglossal nerve, a nerve plexus, nerve ganglia, or a vascular baroreceptor.