Enhancing left ventricular relaxation through neuromodulation

• US 10,639,478 B2
• Filed: 01/31/2018
• Issued: 05/05/2020
• Est. Priority Date: 01/31/2017
• Status: Active Grant

• Current Assignee: Nuxcel Limited
• Original Assignee: Neuro Tronik IP Holding Limited
• Inventors: Cuchiara, Michael, Masson, Stephen C
• Primary Examiner(s): Gedeon, Brian T
• Assistant Examiner(s): Edwards, Philip C
• Application Number:
  US15/884,812
• Publication Number:
  US 20180214698A1
• Time in Patent Office: 825 Days
• Field of Search: 607 9
• CPC Class Codes: A61M 2205/054 with electrotherapy
• CPC Class Codes: A61M 60/13 by means of a catheter allowing explantation, e.g. catheter pumps temporarily introduced via the vascular system
• CPC Class Codes: A61M 60/139 inside the aorta, e.g. intra-aortic balloon pumps
• CPC Class Codes: A61M 60/148 in line with a blood vessel using resection or like techniques, e.g. permanent endovascular heart assist devices
• CPC Class Codes: A61M 60/178 drawing blood from a ventricle and returning the blood to the arterial system via a cannula external to the ventricle, e.g. left or right ventricular assist devices
• CPC Class Codes: A61M 60/216 including a rotating member acting on the blood, e.g. impeller
• CPC Class Codes: A61M 60/295 Balloon pumps for circulatory assistance
• CPC Class Codes: A61M 60/531 using blood pressure data, e.g. from blood pressure sensors
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/36114 Cardiac control, e.g. by vagal stimulation stimulating the heart A61N1/362
• CPC Class Codes: A61N 1/36139 with automatic adjustment
• CPC Class Codes: A61N 1/36153 Voltage A61N1/3616 takes precedence
• CPC Class Codes: A61N 1/36157 Current A61N1/3616 takes precedence
• CPC Class Codes: A61N 1/36171 Frequency
• CPC Class Codes: A61N 1/36175 Pulse width or duty cycle
• CPC Class Codes: A61N 1/36185 Selection of the electrode configuration

Abstract

Neuromodulation is used to enhance left ventricular relaxation. An exemplary neuromodulation system includes a therapy element positionable in proximity to at least one nerve fiber, and a stimulator configured to energize the therapy element to delivery therapy to the at least one nerve fiber such that left ventricular relaxation and left ventricular contractility are contemporaneously enhanced.

Claims

1. A method of treating a patient having a left ventricular contractility (LVC) and a left ventricular relaxation (LVR), comprising:

administering an inotropic agent to the patient to enhance LVC and delivering neuromodulation therapy to the patient to contemporaneously enhance LVR, such that the ratio of the enhancement of LVC to the enhancement of LVR is within a predetermined range, wherein the enhancement of LVR is determined by determining the increase in a value selected from dP/dt min in diastole, arterial blood pressure (ABP) in diastole, tau in diastole, mitral valve deceleration time or mitral valve velocity time interval from prior to initiation of neuromodulation to after initiation of neuromodulation.

2. The method of claim 1, wherein the neuromodulation therapy includes:

using a therapy element positioned in an intravascular location to neuromodulate at least one extravascular nerve fiber to increase LVR.

3. The method of claim 2, wherein the intravascular location is selected from the group of blood vessels consisting of the superior vena cava, left brachiocephalic vein and right brachiocephalic vein.

4. The method of claim 2, wherein the intravascular location is selected from the group of blood vessels consisting of the superior vena cava, left brachiocephalic vein, lower internal jugular vein, right brachiocephalic vein, azygos vein or azygos arch.

5. The method of claim 1, wherein the neuromodulation therapy is delivered to enhance LVR such that the ratio of the percentage increase of LVC to the percentage increase of LVR is within a predetermined range.

6. The method of claim 5, wherein the predetermined range is 0.5-1.5.

7. The method of claim 5, wherein the predetermined range is 0.8-1.2.

8. The method of claim 5, wherein the predetermined range is approximately 1.0.

9. The method of claim 1 wherein the method includes automatically adjusting at least one neuromodulation parameter such that the ratio of the enhancement of LVC to the enhancement of LVR is within the predetermined range.

10. The method of claim 9, wherein the therapy elements are electrodes and the neuromodulation parameter adjusted by the system is at least one of electrical currents, voltages, and pulse widths, pulse frequency, charge density, effective electrode surface area, effective electrode spacing, and electrode combinations energized.

11. A method of treating a patient having a left ventricular contractility (LVC) and a left ventricular relaxation (LVR), comprising:

administering an inotropic agent to the patient to enhance LVC and delivering neuromodulation therapy to the patient to contemporaneously enhance LVR, such that the ratio of the enhancement of LVC to the enhancement of LVR is within a predetermined range, wherein the enhancement of LVC is determined by determining the increase in the value selected from dP/dt max in systole, ABP in systole, from prior to initiation of neuromodulation to after initiation of neuromodulation.

12. The method of claim 11, wherein the neuromodulation therapy includes:

using a therapy element positioned in an intravascular location to neuromodulate at least one extravascular nerve fiber to increase LVR.

13. The method of claim 12, wherein the intravascular location is selected from the group of blood vessels consisting of the superior vena cava, left brachiocephalic vein and right brachiocephalic vein.

14. The method of claim 12, wherein the intravascular location is selected from the group of blood vessels consisting of the superior vena cava, left brachiocephalic vein, lower internal jugular vein, right brachiocephalic vein, azygos vein or azygos arch.

15. The method of claim 11, wherein the neuromodulation therapy is delivered to enhance LVR such that the ratio of the percentage increase of LVC to the percentage increase of LVR is within a predetermined range.

16. The method of claim 15, wherein the predetermined range is 0.5-1.5.

17. The method of claim 15, wherein the predetermined range is 0.8-1.2.

18. The method of claim 15, wherein the predetermined range is approximately 1.0.

19. The method of claim 11 wherein the method includes automatically adjusting at least one neuromodulation parameter such that the ratio of the enhancement of LVC to the enhancement of LVR is within the predetermined range.

20. The method of claim 11, wherein the therapy elements are electrodes and the neuromodulation parameter adjusted by the system is at least one of electrical currents, voltages, and pulse widths, pulse frequency, charge density, effective electrode surface area, effective electrode spacing, and electrode combinations energized.