IP Library Granted Patent US 11,864,826
Granted Patent B2
US 11,864,826 · App. 17/171,447 · Granted Jan 9, 2024

Devices and methods for treatment of heart failure by splanchnic nerve ablation

Inventors: Howard Levin (Teaneck, NJ); Mark Gelfand (New York, NY)
Assignee: Axon Therapies, Inc.
A61B18/1492A61N1/00A61N1/36017A61B2018/00214A61B2018/00404A61B2018/00434A61B2018/00791A61B2018/00863A61B2018/00875A61B2090/064
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Quick Facts
Patent No.
US 11,864,826
App. No.
17/171,447
Filed
Feb 9, 2021
Granted
Jan 9, 2024
Kind
B2
Art Unit
3794
USPC
606/34
Abstract

A method for treating a heart failure patient by ablating a nerve of the splanchnic sympathetic nervous system to increase venous capacitance and reduce pulmonary blood pressure. A method including: inserting a catheter into a vein adjacent the nerve, applying stimulation energy and observing hemodynamic effects, applying ablation energy and observing hemodynamic effects, applying simulation energy after the ablation and observing hemodynamic effects.

Claims (25)

1. A method of ablating a greater splanchnic nerve to treat a patient diagnosed with heart failure, comprising:

positioning an endovascular catheter comprising a proximal region, a flexible shaft, and a distal region, wherein the flexible shaft connects the proximal and distal regions and has a length adapted and sufficient to access an azygos vein space of a T9, T10, or T11 thoracic vertebra of the patient relative to an access location when the proximal region remains external to the patient, the distal region comprising one or more ablation elements;

advancing the distal region through an azygos vein;

advancing the distal region from the azygos vein at least partially into a T9, T10, or T11 intercostal vein;

activating the one or more ablation elements;

delivering ablative energy to the greater splanchnic nerve using the one or more ablation elements while the distal region is at least partially in the T9, T10, or T11 intercostal vein; and

removing the endovascular catheter from the patient.

2. The method of claim 1 , further comprising confirming a proper position of the one or more ablation elements in the T9, T10, or T11 intercostal vein.

3. The method of claim 1 , further comprising confirming that the greater splanchnic nerve has been ablated.

4. The method of claim 1 , wherein the one or more ablation elements comprises an inflatable balloon, the method further comprising inflating the inflatable balloon in the T9, T10, or T11 intercostal vein.

5. The method of claim 4 , wherein the inflatable balloon has a cylindrically shaped inflated configuration, wherein expanding the balloon comprises expanding the balloon towards the cylindrically shaped configuration.

6. The method of claim 4 , wherein inflating the inflatable balloon comprises inflating the balloon to have a diameter from 2 mm-6 mm.

7. The method of claim 1 , further comprising distending a wall of the T9, T10, or T11 intercostal vein.

8. The method of claim 1 , wherein advancing the distal region from the azygos vein and at least partially into the T9, T10, or T11 intercostal vein comprises advancing the distal region at least partially into a right T9, T10, or T11 intercostal vein.

9. The method of claim 1 , wherein the heart failure comprises heart failure with preserved ejection fraction.

10. The method of claim 1 , further comprising, at a time subsequent to activating the one or more ablation elements, assessing the patient's heart failure by assessing one or more of the patient's exercise capacity, blood pressure, or neurohormonal changes.

11. The method of claim 1 , wherein delivering the ablative energy to the greater splanchnic nerve causes an increase in exercise tolerance.

12. The method of claim 1 , wherein delivering the ablative energy to the greater splanchnic nerve causes a decrease in blood pressure.

13. A method of ablating a greater splanchnic nerve to treat a patient diagnosed with heart failure, comprising:

advancing a guidewire through an azygos vein and into a T9, T10, or T11 intercostal vein;

positioning an endovascular catheter comprising a proximal region, a flexible shaft, and a distal region, wherein the flexible shaft connects the proximal and distal regions and has a length adapted and sufficient to access an azygos vein space of a T9, T10, or T11 vertebra of the patient relative to an access location when the proximal region remains external to the patient, the distal region comprising one or more ablation elements;

advancing the distal region over the guidewire, through the azygos vein into the azygos vein space of the T9, T10, or T11 thoracic vertebra;

activating the one or more ablation elements;

delivering ablative energy to the greater splanchnic nerve using the one or more ablation elements; and

removing the endovascular catheter from the patient.

Assignments (3)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 1, 2025
From: AXON THERAPIES, INC.
To: AXON (ASSIGNMENT FOR THE BENEFIT OF CREDITORS), LLC
Reel/Frame 071149/0588 →
PATENT ASSIGNMENT AGREEMENT Recorded Nov 13, 2024
From: AXON (ASSIGNMENT FOR THE BENEFIT OF CREDITORS), LLC
To: AXON VASCULAR, INC.
Reel/Frame 069353/0549 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Sep 23, 2021
From: LEVIN, HOWARD; GELFAND, MARK
To: AXON THERAPIES, INC.
Reel/Frame 057582/0173 →
Continuity (5)
Continuation 16510503 · Jul 12, 2019
Continuation 15017351 · Feb 5, 2016
Provisional Application 62112395 · Feb 5, 2015
Provisional Application 62162266 · May 15, 2015
Related Publication 20220000545A1 · Jan 6, 2022
Cited By (5)
US 12,408,974 US 12,478,806 US 12,539,167 US 12,629,278 US 12,661,177