IP Library Granted Patent US 11,801,092
Granted Patent B2
US 11,801,092 · App. 17/452,305 · Granted Oct 31, 2023

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

Inventors: Howard Levin (Teaneck, NJ); Mark Gelfand (New York, NY); Zoar Jacob Engelman (New York, NY); Dorin Panescu (San Jose, CA); Mark S. Leung (Duncan, CA)
Assignee: Axon Therapies, Inc.
A61B18/1492A61B2018/00285A61B2018/00434A61B2018/00577A61B2018/00648A61B2018/00702A61B2018/00791A61B2018/00875A61B2018/1467A61N1/36017
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Quick Facts
Patent No.
US 11,801,092
App. No.
17/452,305
Granted
Oct 31, 2023
Kind
B2
Abstract

Apparatuses and methods for treating a heart failure patient by ablating a nerve of the thoracic splanchnic sympathetic nervous system to increase venous capacitance and reduce pulmonary blood pressure. A method comprising: 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 and monitoring for presence of the lung in the ablation zone. An alternative method comprising: inserting a catheter into a vein adjacent the nerve, detecting that lung tissue is a safe distance from an ablation zone, and delivering ablation energy to the target nerve when lung tissue is a safe distance from the ablation zone.

Claims (32)

1. A method of ablating a patient's thoracic splanchnic nerve, comprising:

endovascularly delivering an ablation catheter to one or both of a T 8 , T 9 , T 10 , or T 11 azygos vein space or a T 8 , T 9 , T 10 , or T 11 intercostal vein of the patient, the ablation catheter comprising an ablation element and an intravascular imaging element;

imaging tissue in proximity to the ablation catheter with the imaging element; and

delivering ablative energy using the ablation element when the ablation catheter is in one or both of the T 8 , T 9 , T 10 , or T 11 azygos vein space, or the T 8 , T 9 , T 10 , or T 11 intercostal vein to ablate the thoracic splanchnic nerve.

2. The method of claim 1 , wherein delivering the ablative energy is based on at least one characteristic of the imaged tissue.

3. The method of claim 2 , wherein at least one delivery parameter of the ablative energy is based on the at least one characteristic of the imaged tissue.

4. The method of claim 2 , wherein delivering the ablative energy is based on a distance from the ablation catheter to one or more anatomical structures in the imaged tissue.

5. The method of claim 4 , wherein delivering the ablative energy is based on a distance to one or more a lung, a spine, a sympathetic nerve, an esophagus, or a diaphragm.

6. The method of claim 4 , wherein the ablative energy is titrated based on the distance to the one or more anatomical structures in the tissue.

7. The method of claim 6 , wherein the ablative energy is titrated based on the distance to one or more a lung, a spine, a sympathetic nerve, an esophagus, or a diaphragm.

8. The method of claim 6 , wherein titrating the energy comprises titrating one or more of a magnitude of ablation energy, ramp rate or duration based on the distance to the one or more anatomical structures in the tissue.

9. The method of claim 2 , wherein delivering the ablative energy is based on a position of one or more anatomical structures in the imaged tissue relative to the ablation catheter.

10. The method of claim 9 , wherein delivering the ablative energy is based on a position of one or more a lung, a spine, a sympathetic nerve, an esophagus, or a diaphragm relative to the ablation catheter.

11. The method of claim 9 , wherein the ablative energy is titrated based on the position of the one or more anatomical structures in the imaged tissue relative to the ablation catheter.

12. The method of claim 11 , wherein the ablative energy is titrated based on the position of one or more a lung, a spine, a sympathetic nerve, an esophagus, or a diaphragm in the imaged tissue relative to the ablation catheter.

13. The method of claim 11 , wherein titrating the energy comprises titrating one or more of a magnitude of ablation energy, ramp rate or duration based on the position of the one or more anatomical structures in the imaged tissue relative to the ablation catheter.

14. The method of claim 2 , wherein delivering the ablative energy comprises directing the ablative energy toward the thoracic splanchnic nerve.

15. The method of claim 2 , wherein delivering the ablative energy comprises directing the ablative energy away from non-target tissue.

16. The method of claim 1 , further comprising using the imaged tissue to determine a correct position of the ablation catheter to deliver the ablative energy towards the thoracic splanchnic nerve.

17. The method of claim 16 , wherein the ablation element comprises one or more RF electrodes, and wherein using the imaged tissue to determine the correct position of the ablation element comprises using the imaged tissue to determine the correct position of the one or more RF electrodes to deliver the ablative energy towards the thoracic splanchnic nerve.

18. The method of claim 17 , wherein the ablation element comprises at least two RF electrodes, and wherein using the imaged tissue to determine the correct position of the ablation element comprises using the imaged tissue to determine the correct position of the at least two RF electrodes to deliver the ablative energy towards the thoracic splanchnic nerve.

19. The method of claim 1 , wherein the imaging element comprises an ultrasound transducer or an array of ultrasound transducers.

20. The method of claim 1 , wherein delivering the ablative energy occurs while the ablation element is disposed in the azygos vein.

21. The method of claim 1 , wherein delivering the ablative energy occurs while the ablation element is disposed in the intercostal vein.

22. The method of claim 21 , wherein delivering the ablative energy occurs while the ablation element is disposed in at least one of a T 8 , T 9 , T 10 , or T 11 intercostal vein.

23. The method of claim 1 , wherein the imaging element is disposed on a distal region of the ablation catheter.

24. The method of claim 1 , wherein the imaging element is positioned distal to the ablation element.

25. The method of claim 1 , wherein the ablation catheter further comprises a stimulation element.

26. The method of claim 25 , further comprising a step of delivering a nerve stimulation signal from the ablation catheter.

27. The method of claim 26 , wherein the stimulation signal is delivered from the ablation element.

28. The method of claim 25 , wherein the stimulation element is a bipolar stimulation element.

29. The method of claim 1 , wherein imaging tissue in proximity to the ablation catheter with the imaging element comprises imaging non-target tissue, and wherein delivering energy comprises directing energy away from the non-target tissue to ablate the thoracic splanchnic nerve.

Assignments (5)
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 May 5, 2022
From: CORIDEA, LLC
To: AXON THERAPIES, INC.
Reel/Frame 059832/0760 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 5, 2022
From: LEVIN, HOWARD; GELFAND, MARK; ENGELMAN, ZOAR JACOB
To: CORIDEA, LLC
Reel/Frame 059832/0925 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 5, 2022
From: PANESCU, DORIN; LEUNG, MARK S.
To: AXON THERAPIES, INC.
Reel/Frame 059833/0048 →
Continuity (5)
Continuation 16318447
Provisional Application 62482142 · Apr 5, 2017
Provisional Application 62411492 · Oct 21, 2016
Provisional Application 62368912 · Jul 29, 2016
Related Publication 20220257315A1 · Aug 18, 2022
Cited By (5)
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