System and method for neuromodulation

• US 9,067,071 B2
• Filed: 07/11/2012
• Issued: 06/30/2015
• Est. Priority Date: 07/11/2011
• Status: Active Grant

• Current Assignee: Nuxcel2 LLC
• Original Assignee: Interventional Autonomics Corporation
• Inventors: Sanders, William E., Masson, Stephen C., Ransbury, Terrance, Stack, Richard S.
• Primary Examiner(s): KAHELIN, MICHAEL WILLIAM
• Application Number:
  US13/547,031
• Publication Number:
  US 20130072997A1
• Time in Patent Office: 1,084 Days
• US Class Current: 1/1
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve 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 1/36135 using physiological parameters
• CPC Class Codes: A61N 1/36139 with automatic adjustment

Abstract

A method of treating autonomic imbalance in a patient includes energizing a first therapeutic element disposed in a superior vena cava of the patient to deliver therapy to a parasympathetic nerve fiber (e.g. vagus nerve), and energizing a second therapeutic element disposed within the superior vena cava to deliver therapy to a sympathetic cardiac nerve fiber. A neuromodulation system includes a parasympathetic therapy element adapted for positioning within a blood vessel, a sympathetic therapy element adapted for positioning within the blood vessel; and a stimulator to energize the parasympathetic therapy element to deliver parasympathetic therapy to a parasympathetic nerve fiber disposed external to the blood vessel and energize the sympathetic therapy element within the blood vessel to deliver sympathetic therapy to a sympathetic nerve fiber disposed external to the blood vessel. The therapy decreases the patient'"'"'s heart rate and elevates or maintains the blood pressure of the patient.

Claims

1. A method of treating autonomic imbalance in a patient having a heart rate and a blood pressure, comprising:

delivering a neuromodulation therapy to sustain or increase the blood pressure while decreasing the heart rate, said neuromodulation therapy including

(a) stimulating at least one parasympathetic nerve fiber using a first therapeutic element comprising first electrodes disposed in a superior vena cava of the patient, wherein said stimulating comprises energizing at least one first electrode; and

(b) stimulating at least one sympathetic nerve fiber using a second therapeutic element comprising second electrodes disposed in the superior vena cava, the first electrodes and second electrodes being different electrodes, wherein staid stimulating comprises energizing at least one second electrode;

wherein steps (a) and (b) include positioning at least one first electrode and at least one second electrode against a posterior side of an internal wall of the superior vena cava.

2. The method of claim 1, further including introducing a therapy device into the vasculature, the therapy device having the first and second therapeutic elements thereon, and advancing the therapy device within the vasculature to position the first and second therapeutic elements within the superior vena cava.

3. The method of claim 1, wherein steps (a) and (b) are performed simultaneously.

4. The method of claim 1 wherein steps (a) and (b) are performed at separate times.

5. The method of claim 1, further including positioning at least one first electrode against a postero-lateral wall of the superior vena cava and performing step (a) using said at least one first electrode.

6. The method of claim 1, further including positioning at least one second electrode against a postero-medial segment of the superior vena cava and performing step (b) using said at least one second electrode.

7. The method of claim 1, further including:

positioning at least one first electrode against a postero-lateral wall of the superior vena cava and performing step (a) using said at least one first electrode,

positioning at least one second electrode against a postero-medial segment of the superior vena cava and performing step (b) using said at least one second electrode.

8. The method of claim 7, wherein said at least one first and second electrodes are positioned in contact with the wall of the SVC along a circumferential band extending 120°

or less around the wall of the superior vena cava, the band having a mid-point at a posterior-most point around a circumference of the superior vena cava.

9. The method of claim 1, wherein the at least one parasympathetic nerve fiber is a vagus nerve fiber.

10. The method of claim 1, wherein the at least one sympathetic nerve fiber is a sympathetic cardiac nerve fiber.

11. The method of claim 1, wherein the method includes positioning the first and second therapeutic elements in a segment of the superior vena cava extending between a right atrium and a junction of brachiocephalic veins.

12. The method of claim 1, further including energizing the first and second therapeutic elements using a stimulator disposed external to the patient.

13. The method of claim 12, further including monitoring blood pressure and heart rate of the patient, and modifying stimulus from the first and second therapeutic elements in response to detected changes in heart rate and/or blood pressure.

14. The method of claim 1 further including independently controlling stimulation of the sympathetic and parasympathetic nerve fibers.

15. A method of treating autonomic imbalance in a patient having a superior vena cava that includes a wall, comprising:

(a) positioning at least one first electrode within the superior vena cava against a postero-lateral segment of the wall of the superior vena cava, and stimulating at least one parasympathetic nerve fiber using said at least one first electrode; and

(b) positioning at least one second electrode within the superior vena cava against a postero-medial segment of the wall of the superior vena cava, and stimulating at least one sympathetic nerve fiber using said at least one second electrode.

16. The method of claim 15, wherein the patient has a blood pressure and a heart rate, and wherein the method sustains or increases the blood pressure while decreasing the heart rate.

17. The method of claim 15, wherein the at least one parasympathetic nerve fiber is a vagus nerve fiber.

18. The method of claim 15, wherein the at least one sympathetic nerve fiber is a sympathetic cardiac nerve fiber.

19. The method of claim 15, wherein step (a) includes energizing the first electrode and step (b) includes energizing the second electrode, wherein the first and second electrodes are different electrodes.

20. A method of treating autonomic imbalance in a patient having a heart rate and a blood pressure, comprising:

delivering a neuromodulation therapy to sustain or increase the blood pressure while decreasing the heart rate, said neuromodulation therapy including

(a) stimulating at least one parasympathetic nerve fiber using a first therapeutic element including a first electrode disposed in a superior vena cava of the patient; and

(b) stimulating at least one sympathetic nerve fiber using a second therapeutic element including a second electrode disposed in the superior vena cava,

wherein said at least one first and second electrodes are positioned in contact with the wall of the SVC along a circumferential band extending 270°

or less around the wall of the superior vena cava, the band having a mid-point at a posterior- most point around a circumference of the superior vena cava.