Devices and methods for electrode implantation

• US 8,755,907 B2
• Filed: 05/21/2013
• Issued: 06/17/2014
• Est. Priority Date: 10/22/2003
• Status: Active Grant

• Current Assignee: CVRx, Inc.
• Original Assignee: CVRx, Inc.
• Inventors: Kieval, Robert S., Rossing, Martin A.
• Primary Examiner(s): Koharski, Christopher D
• Assistant Examiner(s): Patel, Natasha
• Application Number:
  US13/898,972
• Publication Number:
  US 20130253626A1
• Time in Patent Office: 392 Days
• Field of Search: 607/115, 607/118, 607/126, 607/149
• US Class Current: 607/118
• CPC Class Codes: A61N 1/0556 Cuff electrodes
• CPC Class Codes: A61N 1/36071 Pain
• CPC Class Codes: A61N 1/36114 Cardiac control, e.g. by vagal stimulation stimulating the heart A61N1/362

Abstract

Systems and methods provide baroreflex activation to treat or reduce pain and/or to cause or enhance sedation or sleep. Methods involve activating the baroreflex system to provide pain reduction, sedation, improved sleep or some combination thereof. Systems include at least one baroreflex activation device, at least one sensor for sensing physiological activity of the patient, and a processor coupled with the baroreflex activation device(s) and the sensor(s) for processing sensed data received from the sensor and for activating the baroreflex activation device. In some embodiments, the system is fully implantable within a patient, such as in an intravascular, extravascular or intramural location.

Claims

1. A system for implantation of a medical lead configured to deliver electrical stimulation to nerve tissue located adjacent a blood vessel, the system comprising:

an electrode;

a means for delivering the electrode through a lumen of the blood vessel;

a means for determining a suitable implant location for the electrode proximate the nerve tissue; and

a means for deploying the electrode through a wall of the blood vessel, so as to position the electrode outside of the blood vessel proximate the nerve tissue,

wherein the means for determining is configured to detect one or more physiological signals from the patient in response to a baroreceptor activation signal delivered through the electrode.

2. The system of claim 1, wherein the means for determining comprises a physiological sensor.

3. The system of claim 2, wherein the physiological sensor comprises one of a sense electrode, pressure sensor, pressure transducer, ultrasound sensor, motion sensor, acoustic sensor, optical sensor, blood oxygen sensor, activity sensor, posture state sensor, respiration sensor, or temperature sensor.

4. The system of claim 1, wherein the physiological sensor is configured to detect one or more of neurological activity, electrocardiogram, heart rate, blood pressure, blood flow, blood oxygen content, cardiac output, respiration, nerve signals.

5. The system of claim 1, wherein the means for deploying is configured to temporarily deploy and retract the electrode so as to deliver the baroreceptor activation signal from multiple locations prior to deploying the electrode.

6. The system of claim 1, further comprising:

a lead connected to the electrode and configured to be connectable to a pulse generator.

7. The system of claim 1, further comprising a means for anchoring the electrode outside of the blood vessel adjacent the nerve tissue.

8. The method of claim 1, wherein the blood vessel is selected from the group consisting of:

a carotid sinus, an aortic arch, a common carotid artery, a subclavian artery, a brachiocephalic artery, pulmonary artery, pulmonary vein, jugular vein, femoral artery, femoral vein, and a heart.

9. A system for implantation of a medical lead configured to deliver electrical stimulation to nerve tissue located adjacent a blood vessel, the system comprising:

an electrode;

a means for delivering the electrode through a lumen of the blood vessel;

a means for determining a suitable implant location for the electrode proximate the nerve tissue; and

a means for deploying the electrode through a wall of the blood vessel, so as to position the electrode outside of the blood vessel proximate the nerve tissue,

wherein the nerve tissue comprises a baroreceptor disposed in the wall of the blood vessel, or a carotid sinus nerve.

10. The method of claim 9, wherein the blood vessel is selected from the group consisting of:

a carotid sinus, an aortic arch, a common carotid artery, a subclavian artery, a brachiocephalic artery, pulmonary artery, pulmonary vein, jugular vein, femoral artery, femoral vein, and a heart.

11. A method comprising:

delivering a lead through a lumen of a blood vessel to a location proximate a target nerve tissue site outside the blood vessel, the lead including an electrode at a distal end;

determining a suitable implant location for the electrode;

advancing the lead from within the lumen such that the electrode passes through a wall of the blood vessel; and

determining a suitable implant location for the electrode, proximate the nerve tissue,

wherein determining a suitable implant location for the electrode comprises a mapping procedure including;

delivering a baroreceptor activation signal through the electrode from a plurality of locations within the blood vessel; and

measuring a patient response to each baroreceptor activation signal.

12. The method of claim 11, further comprising temporarily deploying the electrode toward the nerve tissue at each location.

13. The method of claim 11, further comprising anchoring the electrode outside of the blood vessel adjacent the nerve tissue.

14. The method of claim 11, wherein the blood vessel is selected from the group consisting of:

a carotid sinus, an aortic arch, a common carotid artery, a subclavian artery, a brachiocephalic artery, pulmonary artery, pulmonary vein, jugular vein, femoral artery, femoral vein, and a heart.

15. A method comprising:

delivering a lead through a lumen of a blood vessel to a location proximate a target nerve tissue site outside the blood vessel, the lead including an electrode at a distal end;

determining a suitable implant location for the electrode; and

advancing the lead from within the lumen such that the electrode passes through a wall of the blood vessel,

wherein the nerve tissue comprises one of a baroreceptor disposed in the wall of the blood vessel, or a carotid sinus nerve.

16. The method of claim 15, further comprising:

determining a suitable implant location for the electrode, proximate the nerve tissue.