VAGUS NERVE STIMULATION ELECTRODES AND METHODS OF USE

• US 20090275997A1
• Filed: 05/01/2009
• Published: 11/05/2009
• Est. Priority Date: 05/01/2008
• Status: Abandoned Application

• Current Assignee: James W. Broderick, Kevin J. Tracey, Michael Allen Faltys
• Original Assignee: James W. Broderick, Kevin J. Tracey, Michael Allen Faltys
• Inventors: Faltys, Michael Allen, Broderick, James W., Tracey, Kevin J.
• Application Number:
  US12/434,462
• Publication Number:
  US 20090275997A1
• Time in Patent Office: Days
• US Class Current: 607/2
• CPC Class Codes: A61N 1/0553 Paddle shaped electrodes, e.g. for laminotomy
• CPC Class Codes: A61N 1/0556 Cuff electrodes
• CPC Class Codes: A61N 1/056 Transvascular endocardial electrode systems
• CPC Class Codes: A61N 1/36053 adapted for vagal stimulation A61N1/36114 takes precedence
• CPC Class Codes: A61N 1/36114 Cardiac control, e.g. by vagal stimulation stimulating the heart A61N1/362
• CPC Class Codes: A61N 2001/0585 Coronary sinus electrodes

Abstract

Described herein are systems, method and devices for modulating the cholinergic anti-inflammatory pathway. The systems described herein may include one or more implantable leads configured to be used to stimulate the inflammatory reflex. These leads typically include a flexible body region, a plurality of electrodes (or contacts) and may be used with a stylet or other inserter. The leads may also include one or more anchors. Exemplary leads may be intra-carotid sheath field-effect leads (“sheath FE” leads), carotid sheath cuff leads (“sheath cuff” leads), intracardiac leads, vagus nerve cuff leads (“vagus cuff” leads), and intravenous leads (“intravascular” leads). Leads (e.g., intravascular leads) may be chronic or acute.

Claims

1. A method of modulating inflammation by stimulation of the cholinergic anti-inflammatory pathway, the method comprising:

positioning a flexible lead within a blood vessel;

confirming that each of a plurality of electrodes on the flexible lead are secured against the wall of the blood vessel;

anchoring the flexible lead within the blood vessel; and

modulating the cholinergic anti-inflammatory pathway by applying energy to one or more stimulation electrodes on the flexible lead to stimulate the vagus nerve.

2. The method of claim 1, wherein the step of positioning the lead within the blood vessel comprises positioning the lead within the internal jugular vein.

3. The method of claim 2, wherein the step of positioning the flexible lead in the carotid sheath comprises inserting the lead using a subclavian approach.

4. The method of claim 1, wherein the step of positioning the lead within the blood vessel comprises positioning the lead within the coronary sinus or the pulmonary artery.

5. The method of claim 1, further comprising determining the stimulation electrodes by applying energy from the lead to alter the subject'"'"'s heart rate.

6. The method of claim 1, wherein the flexible lead comprises a helical flexible lead.

7. The method of claim 1, wherein the step of confirming that each of the plurality of electrodes on the flexible lead are secured against the wall of the blood vessel comprises testing the impedance of each electrode.

8. The method of claim 1, further comprising removing the lead from the blood vessel.

9. The method of claim 1, further comprising implanting a controller, wherein the controller is configured to control the application of energy from the stimulation electrodes.

10. A method of modulating inflammation by stimulation of the cholinergic anti-inflammatory pathway, the method comprising:

positioning a flexible lead in a carotid sheath so that the lead does not contact the vagus nerve;

anchoring the lead within the carotid sheath; and

modulating the cholinergic anti-inflammatory pathway by applying energy to one or more stimulation electrodes on the flexible lead to stimulate the vagus nerve.

11. The method of claim 10, further comprising determining the stimulation electrode or electrodes from among a plurality of electrodes on the flexible lead by applying energy from among the electrodes on the flexible lead and monitoring heart rate.

12. The method of claim 10, wherein the step of positioning the flexible lead in the carotid sheath comprises inserting the lead using a subclavian approach.

13. The method of claim 10, further comprising coupling the flexible lead to a stylet to aid insertion before inserting the flexible lead into the carotid sheath.

14. The method of claim 13, further comprising removing the stylet from the flexible lead after insertion.

15. A method of modulating inflammation by stimulation of the cholinergic anti-inflammatory pathway, the method comprising:

positioning a carotid sheath cuff lead around a carotid sheath so that the carotid sheath cuff lead does not contact the vagus nerve;

anchoring the carotid sheath cuff lead around the carotid sheath so that stimulation electrodes located within the carotid sheath cuff lead are oriented towards the vagus nerve within the carotid sheath; and

modulating the cholinergic anti-inflammatory pathway by applying energy to one or more stimulation electrodes within the carotid sheath cuff lead to stimulate the vagus nerve.

16. The method of claim 15, wherein the step of positioning the carotid sheath cuff lead around the carotid sheath comprises surgically cutting down to the carotid sheath.

17. The method of claim 15, further comprising suturing the carotid sheath cuff around the carotid sheath.

18. The method of claim 15, wherein the carotid sheath cuff is insulated on the outer surface of the cuff to prevent stimulation of surrounding tissue.