Neuromodulation systems and methods for treating acute heart failure syndromes

• US 9,126,048 B2
• Filed: 10/28/2013
• Issued: 09/08/2015
• Est. Priority Date: 04/28/2011
• Status: Active Grant

• Current Assignee: Nuxcel2 LLC
• Original Assignee: Interventional Autonomics Corporation
• Inventors: Ransbury, Terrance J, Sanders, William E, Stack, Richard S, Stack, Colleen
• Primary Examiner(s): MANUEL, GEORGE C
• Application Number:
  US14/064,544
• Publication Number:
  US 20140052208A1
• Time in Patent Office: 680 Days
• Field of Search: 607/14
• US Class Current: 1/1
• CPC Class Codes: A61B 5/01 Measuring temperature of body parts ; Diagnostic temperature sensing, e.g. for malignant or inflamed tissue clinical contact thermometers G01K13/20
• CPC Class Codes: A61B 5/0215 by means inserted into the body catheters A61M25/00
• CPC Class Codes: A61B 5/024 Detecting, measuring or recording pulse rate or heart rate A61B5/0205, A61B5/021 take precedence
• CPC Class Codes: A61M 2025/0175 having telescopic features, interengaging nestable members movable in relations to one another
• CPC Class Codes: A61M 25/0074 Dynamic characteristics of the catheter tip, e.g. openable, closable, expandable or deformable
• CPC Class Codes: A61M 25/0125 Catheters carried by the bloodstream, e.g. with parachutes; Balloon catheters specially designed for this purpose
• CPC Class Codes: A61M 25/0147 with movable mechanical means, e.g. pull wires
• CPC Class Codes: A61M 25/04 in the body, e.g. expansible A61M25/10, A61M16/0488 take precedence
• CPC Class Codes: A61N 1/056 Transvascular endocardial electrode systems
• CPC Class Codes: A61N 1/057 Anchoring means; Means for fixing the head inside the heart
• CPC Class Codes: A61N 1/36114 Cardiac control, e.g. by vagal stimulation stimulating the heart A61N1/362
• CPC Class Codes: A61N 1/3621 for treating or preventing abnormally high heart rate
• CPC Class Codes: A61N 1/3627 for treating a mechanical deficiency of the heart, e.g. congestive heart failure or cardiomyopathy

Abstract

A neuromodulation system for treating acute heart failure syndromes includes a first catheter having a parasympathetic therapy element adapted for positioning within a first blood vessel such as a superior vena cava, and a second catheter sympathetic therapy element adapted for positioning with a second, different, blood vessel such as the pulmonary artery. The catheters comprise a system in which one of catheters is slidably disposed over the other of the catheters. The system may further be slidably disposed over a third elongate element such as a Swan-Ganz catheter positionable within a pulmonary artery, such that the Swan-Ganz may be used for monitoring parameters such as blood pressure and cardiac output during neuromodulation therapy. The parasympathetic therapy element is energized to deliver neuromodulation therapy to a parasympathetic nerve fiber such as a vagus nerve, while the sympathetic therapy element is energized to deliver neuromodulation therapy to a sympathetic nerve fiber such as a sympathetic cardiac nerve fiber. For treatment of acute heart failure syndromes, the neuromodulation therapy may be used to lower heart rate and increase cardiac inotropy.

Claims

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

a first catheter having a parasympathetic therapy element adapted for positioning within a first blood vessel;

a second catheter having a sympathetic therapy element adapted for positioning with a second blood vessel different than the first blood vessel, wherein one of the first and second catheters is slidably disposed within a second one of the first and second catheters;

a stimulator configured to (a) energize the parasympathetic therapy element within the first blood vessel to deliver parasympathetic therapy to a parasympathetic nerve fiber disposed external to the first blood vessel and (b) energize the sympathetic therapy element within the second blood vessel to deliver sympathetic therapy to a sympathetic nerve fiber disposed external to the second blood vessel.

2. The system of claim 1, wherein the stimulator is configured to energize the parasympathetic and sympathetic therapy elements such that delivery of the parasympathetic and sympathetic therapy decreases the patient'"'"'s heart rate and increases inotropy of the heart of the patient.

3. The system of claim 1, further including control means for controlling the parasympathetic and sympathetic stimulation in response to sensed heart rate and/or blood pressure of the patient.

4. The system of claim 1, wherein each catheter includes an element carrying member, the element carrying members at least partially expandable to position the sympathetic and parasympathetic elements in contact with surrounding vascular walls.

5. The system of claim 1, wherein each therapy element comprises at least one electrode.

6. The system of claim 1, wherein the first catheter is slidably received over the second catheter.

7. The system of claim 6, further including an elongate element percutaneously introducible into the vasculature, wherein the second catheter is slidably received over the elongate element.

8. The system of claim 7, wherein the elongate element is a third catheter.

9. The system of claim 8, wherein the third catheter is a pulmonary artery catheter having sensors thereon.

10. The system of claim 9 wherein the pulmonary artery catheter is a Swan-Ganz catheter.

11. The system of claim 1, wherein the first blood vessel is a superior vena cava, and the second blood vessel is a pulmonary artery.

12. The system of claim 1, wherein the first blood vessel is a venous vessel superior to the heart.

13. The system of claim 12, wherein the first blood vessel is a superior vena cava.

14. The system of claim 12, wherein the second blood vessel is a pulmonary artery.

15. A medical treatment method, comprising the steps of:

percutaneously introducing an elongate member into a vasculature of a patient and positioning a distal portion of the elongate member in a pulmonary artery;

slidably advancing a sympathetic neuromodulation catheter over the elongate member, and positioning a sympathetic therapy element on the sympathetic neuromodulation catheter within the pulmonary artery;

slidably advancing a parasympathetic neuromodulation catheter over the sympathetic neuromodulation catheter member, and positioning a parasympathetic therapy element on the parasympathetic stimulation catheter within the superior vena cava;

modulating at least one parasympathetic nerve fiber using the parasympathetic therapy element disposed within the superior vena cava; and

modulating at least one sympathetic nerve fiber using the sympathetic therapy element a second therapeutic element disposed within the pulmonary artery.

16. The treatment method of claim 15, wherein the elongate member is a Swan-Ganz catheter, and wherein the method further includes monitoring at least one of blood pressure and cardiac output using parameters sensed using the Swan-Ganz catheter.

17. The treatment method of claim 15, wherein the therapy elements are electrodes, and wherein the method includes energizing the electrodes to modulate the nerve fibers.

18. The treatment method of claim 15, wherein at least one of the sympathetic and parasympathetic therapy elements is carried by an element carrying member, and wherein the method includes, within the blood vessel, expanding the element carrying member to position the therapy element into contact with an interior wall of the blood vessel.

19. The treatment method of claim 15, wherein modulating the sympathetic and parasympathetic nerve fibers decreases heart rate and increases inotropy of the patient.

20. The treatment method of claim 19, wherein the sympathetic nerve fiber is a sympathetic cardiac nerve fiber, and wherein the parasympathetic nerve fiber is a vagus nerve fiber.