Techniques for placing medical leads for electrical stimulation of nerve tissue

• US 8,532,793 B2
• Filed: 04/30/2009
• Issued: 09/10/2013
• 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, Klepfer, Ruth N., Burnes, John E.
• Primary Examiner(s): Koharski, Christopher D
• Assistant Examiner(s): MAHMOOD, NADIA AHMAD
• Application Number:
  US12/433,809
• Publication Number:
  US 20090276023A1
• Time in Patent Office: 1,594 Days
• Field of Search: 607/130
• US Class Current: 607/130
• 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 delivery system for deploying an implantable medical lead in a lumen of a blood vessel for stimulation of extravascular nerve tissue that is located adjacent to the blood vessel, via at least one electrode of the lead, the system comprising:

an intravascular delivery catheter including a distal end, an aperture formed in a sidewall thereof to allow transverse passage out from the catheter, and a sensor located between the distal end and the aperture, the sensor adapted to radiate ultrasonic waves in order locate the extravascular nerve tissue, when the distal end of the catheter is inserted in the blood vessel lumen;

a tubular member extendable and retractable from the catheter, via the aperture, the tubular member having a lumen configured to receive the implantable lead for advancing the lead out from the catheter and into the blood vessel lumen, when the tubular member is extended from the catheter;

and

a guidewire, along which the lead is advanceable, when the lead is received in the lumen of the tubular member, the guidewire being received within the lumen of the tubular member and advanceable therein, the guidewire including an anchor portion, the anchor portion being located at a distal end of the guidewire and distal to the lead, when the lead is advanced along the guidewire, the anchor portion being configured to temporarily anchor the guidewire to the wall of the blood vessel lumen, when the lead is advanced thereover and out from the catheter.

2. The system of claim 1, wherein the tubular member further includes an electrode.

3. The system of claim 1, wherein the nerve tissue comprises one of a vagus nerve, a hypoglossal nerve, a nerve plexus, nerve ganglia, and a vascular baroreceptor.

7. The system of claim 1, wherein the anchor portion of the guidewire is formed in a spiral that is configured to be twisted into the lumen, when the guidewire is extended from the catheter.

4. A method for deploying, for chronic implant, an implantable medical lead to an intravascular location, the lead including at least one electrode for delivering stimulation to extravascular nerve tissue from the intravascular location, and the method comprising:

deploying a delivery catheter through a lumen of a blood vessel to position a sensor of the catheter at a location in proximity to the nerve tissue, the sensor being located in proximity to a distal end of the catheter, between the distal end of the catheter and an aperture formed in a sidewall of the catheter;

activating the positioned sensor of the catheter to generate an image of an area adjacent the distal end of the catheter and outside of the blood vessel, the image showing a position of the extravascular nerve tissue relative to the blood vessel;

identifying the nerve tissue in the image generated by the activated sensor;

rotating the catheter, after identifying the nerve tissue in the image, to orient the aperture of the catheter toward the identified nerve tissue;

advancing the at least one electrode of the lead out from the oriented aperture of the catheter and toward the identified nerve tissue by advancing the lead over a guidewire, the guidewire being received in a lumen of a tubular member that extends out from the oriented aperture;

actively fixing the advanced electrode to a wall of the blood vessel lumen that is adjacent the identified nerve tissue;

energizing the fixed electrode to deliver stimulation; and

comparing an efficacy of the delivered stimulation to a threshold efficacy.

5. The method of claim 4, wherein actively fixing the electrode to the blood vessel wall comprises screwing a helical wire into the wall.

6. The method of claim 4, wherein the nerve tissue comprises one of a vagus nerve, a hypoglossal nerve, a nerve plexus, nerve ganglia, and a vascular baroreceptor.

8. The method of claim 4, further comprising twisting a distal end of the guidewire into the wall of the blood vessel lumen to temporarily anchor the guidewire.

9. The method of claim 4, further comprising delivering test stimulation pulses via an electrode of the tubular member, prior to advancing the at least one electrode of the lead.