TECHNIQUES FOR PLACING MEDICAL LEADS FOR ELECTRICAL STIMULATION OF NERVE TISSUE

• US 20090275956A1
• 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: Gardeski, Kenneth C., Morris, Mary M., Scheiner, Avram, Macaulay, Patrick E., Burnes, John E., Klepfer, Ruth N.
• Granted Patent: US 9,572,982 B2
• Time in Patent Office: Days
• US Class Current: 606/129
• 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. A system for implantation of an implantable medical lead within a lumen of a blood vessel within a patient for delivery of electrical stimulation to nerve tissue located adjacent to and outside of the blood vessel, the system comprising:

a catheter adapted to be positioned within the blood vessel lumen adjacent the nerve tissue;

an electrode configured to be advanced toward a wall of the blood vessel lumen; and

a sensor configured to detect the relative positions of the nerve tissue outside of the blood vessel and the electrode within the blood vessel lumen.

2. The system of claim 1, wherein the electrode is connected to a distal portion of the catheter.

3. The system of claim 2, further comprising a lead including at least one lead electrode, wherein the lead is received within and advanceable from a distal end of the catheter toward the wall of the blood vessel lumen to position the lead electrode adjacent the nerve tissue.

4. The system of claim 1 further comprising a deployment member extendable and retractable from the catheter toward a wall of the blood vessel lumen, wherein the electrode is connected to the deployment member such that the deployment member positions the electrode proximate the wall when the deployment member is extended toward the wall.

5. The system of claim 4, wherein the sensor is connected to the catheter between a distal end of the catheter and a location along the catheter from which the deployment member is extendable and retractable.

6. The system of claim 4, wherein the deployment member comprises:

a guide member; and

a medical lead advancable along the guide member.

7. The system of claim 6 further comprising a tubular member, wherein the guide member and the lead are received within and advanceable through a lumen of the tubular member.

8. The system of claim 7, wherein the electrode is connected to one of the tubular member or the lead.

9. The system of claim 6, wherein the electrode is connected to the lead.

10. The system of claim 6 further comprising an anchor connected to and configured to anchor the deployment member to the wall.

11. The system of claim 10, wherein a distal end of the guide member comprises the anchor.

12. The system of claim 11, wherein the anchor comprises the distal end of the guide member formed in a spiral shape configured to screw into the wall of the blood vessel lumen.

13. The system of claim 10, wherein the anchor is connected to the guide member.

14. The system of claim 6, wherein the guide member is one of a guidewire or a stylus.

15. The system of claim 4 further comprising an anchor connected to and configured to anchor the deployment member to the wall.

16. The system of claim 1, further comprising one or more additional electrodes coupled to one or more implantable medical leads, wherein at least one of the one or more implantable medical leads is received within and advanceable from the catheter toward the wall of the blood vessel lumen to position at least one of the electrodes adjacent the nerve tissue, and wherein at least two of the electrodes are arranged in flanking, non-contacting relationship with the nerve tissue.

17. The system of claim 16, wherein another of the one or more implantable medical leads comprises an extravascularly placed lead or a transvascularly placed lead.

18. The system of claim 1 further comprising a physiological sensor configured to detect one or more physiological signals from the patient.

19. The system of claim 18, wherein the physiological sensor comprises one of a sense electrode, pressure sensor, ultrasound sensor, motion sensor, acoustic sensor, optical sensor, blood oxygen sensor, posture state sensor, respiration sensor, venous biomarker sensor, or temperature sensor.

20. The system of claim 18, wherein the physiological sensor is configured to detect one or more of electrocardiogram, heart rate, blood pressure, blood oxygen content, blood biomarker content, blood flow, cardiac output, respiratory activity, nerve signals, T-wave morphology, heart rate variability, contractility, or AV intervals.

21. 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.

22. A method comprising:

deploying a delivery catheter through a lumen of a blood vessel to a location proximate a target nerve tissue site outside the blood vessel;

identifying a location of the nerve tissue with respect to the blood vessel with one or more sensors;

advancing an electrical stimulation electrode from within the blood vessel lumen toward the nerve tissue.

23. The method of claim 22 further comprising energizing the electrode to deliver electrical stimulation from within the blood vessel lumen to the nerve tissue.

24. The method of claim 23 further comprising determining an efficacy of the nerve tissue stimulation.

25. The method of claim 24 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;

or

chronically deploying at least one electrode within the blood vessel lumen adjacent the nerve tissue if the efficacy of the nerve tissue stimulation meets or exceeds the threshold efficacy.

26. The method of claim 25, wherein, if the efficacy of the nerve tissue stimulation does not meet or exceed the threshold efficacy, then further comprising:

energizing the repositioned electrode 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 repositioned electrode meets or exceeds the threshold efficacy.

27. The method of claim 22 further comprising anchoring the one electrode to a wall of the blood vessel lumen adjacent the nerve tissue.

28. The method of claim 22 further comprising arranging at least one additional electrical stimulation electrode adjacent the nerve tissue such that at least two electrodes are arranged in flanking, non-contacting relationship with the nerve tissue.

29. The method of claim 28, wherein the at least one additional electrode is connected to one of an extra, intra, or transvascularly placed lead.

30. The method of claim 22, wherein the one or more sensors are connected to the delivery catheter.

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

32. A method comprising:

deploying a delivery catheter through a lumen of a blood vessel to a location proximate a target nerve tissue site outside the blood vessel;

advancing an electrical stimulation electrode from within the blood vessel lumen toward the nerve tissue;

energizing the electrode to deliver electrical stimulation from within the blood vessel lumen to the nerve tissue;

determining an efficacy of the nerve tissue stimulation; and

chronically deploying the electrode within the blood vessel lumen adjacent the nerve tissue if the efficacy of the nerve tissue stimulation meets or exceeds a threshold efficacy.

33. The method of claim 32, further comprising 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.