SYSTEM AND METHOD FOR NEUROMODULATION

• US 20130072997A1
• Filed: 07/11/2012
• Published: 03/21/2013
• 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.
• Granted Patent: US 9,067,071 B2
• Time in Patent Office: Days
• US Class Current: 607/18
• 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, comprising:

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

(b) stimulating at least one sympathetic nerve fiber using a second therapeutic element disposed in 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 3 wherein steps (a) and (b) are performed at separate times.

5. The method of claim 1, wherein the first and second therapeutic element comprise electrodes, and wherein step (a) includes energizing at least one first electrode and step (b) includes energizing at least one second electrode, wherein the first and second electrodes are different electrodes.

6. The method of claim 5, further including 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.

7. The method of claim 6, 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.

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

9. The method of claim 6, 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, 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.

10. The method of claim 9, wherein the band extends 120°

or less around the wall of the superior vena cava.

11. The method of claim 1, wherein the method decreases heart rate of the patient and sustains or increases blood pressure.

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

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

14. 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.

15. The method of claim 5, further including energizing the first and second therapeutic elements using a stimulator disposed external to the patient.

16. The method of claim 15, 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.

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

18. A method of treating autonomic imbalance in a patient, comprising:

(a) stimulating at least one parasympathetic nerve fiber using a first therapeutic element; and

(a) simulating at least one sympathetic nerve fiber using a second therapeutic element, wherein the method decreases heart rate of the patient and sustains or increases blood pressure of the patient.

19. A neuromodulation system for treating a patient, comprising:

a parasympathetic therapy element adapted for positioning within a blood vessel;

a sympathetic therapy element adapted for positioning with the blood vessel; and

a stimulator configured to (a) energize the parasympathetic therapy element within the blood vessel to deliver parasympathetic therapy to a parasympathetic nerve fiber disposed external to the blood vessel and (b) energize the sympathetic therapy element within the blood vessel to deliver sympathetic therapy to a sympathetic nerve fiber disposed external to the blood vessel, such that delivery of the parasympathetic and sympathetic therapy decreases the patient'"'"'s heart rate and elevates or maintains the blood pressure of the patient.

20. The system of claim 19, further including control means for controlling the parasympathetic and sympathetic stimulation in response to sensed heart rate and/or blood pressure of the patient.

21. The system of claim 20, wherein the control means independently controls the parasympathetic and sympathetic stimulation.

22. The system of claim 19, further including a therapy device supporting the sympathetic and parasympathetic therapy elements.

23. The system of claim 22, wherein the therapy device includes a distal portion at least partially expandable or biased to position the sympathetic and parasympathetic elements in contact with a surrounding wall of the blood vessel.

24. The system of claim 23, wherein the distal portion is expandable or biased to position the parasympathetic element against a postero-lateral wall of a superior vena cava and to position the sympathetic element against a postero-medial segment of the superior vena cava.

25. The system of claim 22 wherein the therapy device is a catheter.

26. The system of claim 19, wherein the sympathetic and parasympathetic elements are electrodes.

27. A method of treating a patient, comprising:

energizing a sympathetic therapy element within a superior vena cava of a patient to deliver sympathetic therapy to a sympathetic nerve fiber disposed external to the superior vena cava, such that delivery of the sympathetic therapy elevates or maintains the blood pressure of the patient.

28. The method of claim 27, further including delivering the sympathetic therapy from a postero-medial segment of the mid to cranial portion of the superior vena cava.

29. A neuromodulation system for treating a patient, comprising:

a sympathetic therapy element adapted for positioning within a superior vena cava; and

a stimulator configured to energize the sympathetic therapy element within the superior vena cava to deliver sympathetic therapy to a sympathetic nerve fiber disposed external to the blood vessel, such that delivery of the sympathetic therapy elevates or maintains the blood pressure of the patient.

30. The system of claim 29, further including control means for controlling the sympathetic stimulation in response to sensed heart rate and/or blood pressure of the patient.

31. The system of claim 29, further including a therapy device supporting the sympathetic therapy elements, the therapy device including a distal portion at least partially expandable or biased to position the sympathetic elements in contact with a surrounding wall of the superior vena cava.

32. The system of claim 31, wherein the distal portion is expandable or biased to position the parasympathetic element against a postero-medial segment of the superior vena cava.

33. The system of claim 31 wherein the therapy device is a catheter.