TECHNIQUES FOR PLACING MEDICAL LEADS FOR ELECTRICAL STIMULATION OF NERVE TISSUE

• US 20090276023A1
• Filed: 04/30/2009
• Published: 11/05/2009
• Est. Priority Date: 04/30/2008
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Morris, Mary M., Scheiner, Avram, Burnes, John E., Klepfer, Ruth N.
• Granted Patent: US 8,532,793 B2
• Time in Patent Office: Days
• US Class Current: 607/116
• 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 lead 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 medical lead arranged within a lumen of the blood vessel;

an electrode connected toward a distal end of the lead adjacent the nerve tissue; and

an active fixation member connected toward a distal end of the lead adjacent the nerve tissue and configured to anchor the lead to a wall of the blood vessel lumen.

2. The system of claim 1, wherein the active fixation member comprises a helical wire configured to be screwed into tissue of the blood vessel wall.

3. The system of claim 2, wherein the helical fixation member has a length in the range from and including approximately 0.5 millimeters to and including approximately 2.5 millimeters.

4. The system of claim 3, wherein the length of the helical fixation member is in the range from and including approximately 1 millimeters to and including approximately 2 millimeters.

5. The system of claim 2, wherein a pitch of the helical fixation member is in the range from and including approximately 0.5842 millimeters to and including approximately 1.016 millimeters.

6. The system of claim 1, further comprising a catheter configured to be arranged within a lumen of the blood vessel adjacent the nerve tissue, wherein the medical lead is advanceable from catheter to the wall of the blood vessel lumen.

7. The system of claim 6, wherein a distal end of the catheter is configured to direct the medical lead transversely toward the wall of the blood vessel lumen when the medical lead is advanced from the distal end of the catheter.

8. The system of claim 6, further comprising a deployment member extendable and retractable from the catheter to arrange the lead, electrode and active fixation member proximate the blood vessel wall adjacent the nerve tissue.

9. The system of claim 8, wherein the deployment member comprises at least one of a guide member or a tubular member within and through a lumen of which the medical lead is received and advanceable.

10. The system of claim 9, wherein the guide member comprises one of a guidewire or a stylus.

11. The system of claim 8, further comprising an electrode connected to at least one of the catheter or the deployment member.

12. 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 baroreceptor.

13. The system of claim 1 wherein the active fixation member comprises one or more of a plurality of barbs or hooks configured to engage tissue of the blood vessel wall.

14. The system of claim 1, wherein the active fixation member comprises the electrode.

15. The system of claim 1, wherein the active fixation member comprises an additional electrode.

16. A method comprising:

deploying a lead through a lumen of a blood vessel to a target nerve tissue site;

arranging an electrode connected to the lead within the blood vessel lumen adjacent the nerve tissue; and

actively fixing the lead to a wall of the blood vessel lumen.

17. The method of claim 16 further comprising energizing the electrode to deliver electrical stimulation from within the blood vessel lumen to the nerve tissue.

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

19. The method of claim 18 further comprising:

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

repositioning the delivery catheter and the electrode within the blood vessel lumen if the efficacy of the nerve tissue stimulation does not meet or exceed the threshold efficacy.

20. The method of claim 16, wherein actively fixing the lead to the blood vessel wall comprises screwing a helical wire into tissue of the wall.

21. 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 baroreceptors.