Granted Patent B2

US 12,661,177 · App. 17/810,756 · Granted Jun 23, 2026

Inventors: Howard Levin (Teaneck, NJ); Mark Gelfand (New York, NY)

Assignee: Axon Vascular, Inc.

A61B18/1492A61N1/00A61N1/36017A61B2018/00214A61B2018/00404A61B2018/00434A61B2018/00791A61B2018/00863A61B2018/00875A61B2090/064

Abstract

Claims (56)

1 . A method for treating a patient diagnosed with heart failure, comprising:

advancing a distal region of an endovascular catheter through a femoral vein access or a jugular vein of the human patient with retaining a proximal region of the endovascular catheter external to the human patient,

advancing the distal region of an endovascular catheter into an azygos vein or in a T9, T10 or T11 intercostal vein;

expanding a deployable structure on the distal region in the azygos vein or the T9, T10 or T11 intercostal vein to move one or more stimulation elements and one or more energy delivery elements on the deployable structure towards a wall of the azygos vein or the T9, T10 or T11 intercostal vein;

transmitting a stimulation signal from the one or more stimulation elements into the azygos vein or the T9, T10 or T11 intercostal vein;

determining that the deployable structure is proximate to a greater splanchnic nerve by detecting a physiological response of the greater splanchnic nerve to the stimulation signal;

after the determination and while the deployable structure is expanded, activating an energy source disposed external to the patient and in operable communication with the one or more energy delivery elements;

delivering energy from the energy source and through the one or more energy delivery elements to irreversibly disable the greater splanchnic nerve proximate the azygos vein or the T9, T10 or T11 intercostal vein;

contracting the deployable structure, and

removing the endovascular catheter from the patient after the delivering of the energy and the contraction of the deployable structure.

2 . The method of claim 1 , further comprising advancing the distal region of the endovascular catheter into one of the T9, T10, or T11 intercostal vein prior in time to delivering the energy with the one or more energy delivery elements to disable the greater splanchnic nerve.

3 . The method of claim 2 , wherein advancing the distal region into the T9, T10, or T11 intercostal vein comprises advancing at least one of the one or more energy delivery elements into the T9, T10, or T11 intercostal vein.

4 . The method of claim 3 , wherein the endovascular catheter comprises one or more stimulation elements, and wherein advancing the distal region into the T9, T10, or T11 intercostal vein comprises advancing at least one of the one or more stimulation elements into the T9, T10, or T11 intercostal vein.

5 . The method of claim 2 , wherein advancing the distal region into the T9, T10, or T11 intercostal vein comprises advancing a plurality of the one or more energy delivery elements into the T9, T10, or T11 intercostal vein.

6 . The method of claim 1 , wherein the delivering the energy occurs while the one or more energy delivery elements are disposed in the azygos vein at an azygos vein space of a T9, T10 or T11 vertebrae.

7 . The method of claim 1 , wherein the expanding the deployable structure comprises inflating an inflatable structure.

8 . The method of claim 1 , wherein the expanding the deployable structure includes moving the one or more energy delivery elements into apposition with the wall of the azygos vein or the T9, T10 or T11 intercostal vein.

9 . The method of claim 1 , wherein the expanding the deployable structure comprises moving the one or more stimulation elements into apposition with the azygous vein or the T9, T10 or T11 intercostal wall.

10 . The method of claim 6 , wherein the one or more energy delivery elements comprise a plurality of energy delivery elements, and wherein the delivering the energy comprises delivering energy with less than all of the plurality of the energy delivery elements.

11 . The method of claim 1 , wherein advancing the distal region of the endovascular catheter i includes advancing the distal region through a femoral vein or a jugular vein.

12 . The method of claim 1 , wherein the method is a method for treating a patient diagnosed with heart failure with preserved ejection fraction.

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

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

15 . The method of claim 1 , wherein the disabling of the greater splanchnic nerve treats the heart failure and causes an increase in exercise tolerance.

16 . The method of claim 1 , wherein the disabling of the greater splanchnic nerve treats the heart failure and causes a decrease in blood pressure.

17 . A method for increasing splanchnic venous compliance in a patient, 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 is a length sufficient to access a T9, T10, or T11 intercostal vein of the patient relative to an access location when the proximal region remains external to the patient, the distal region comprising at least one electrically conductive element;

advancing the distal region through an azygos vein;

advancing the distal region from the azygos vein and into the T9, T10, or T11 intercostal vein;

expanding a deployable structure on the distal region in the T9, T10 or T11 intercostal vein to move the at least one electrically conductive element on the deployable structure towards a wall of the T9, T10 or T11 intercostal vein;

transmitting a stimulation signal from the at least one electrically conductive element into the T9, T10 or T11 intercostal vein;

determining that the deployable structure is proximate to a greater splanchnic nerve by detecting a physiological response of the greater splanchnic nerve to the stimulation signal;

after the determination and while the deployable structure is expanded, delivering energy from the at least one electrically conductive element into the wall of the T9, T10 or T11 intercoastal vein to irreversibly disable the greater splanchnic nerve proximate the azygos vein or the T9, T10 or T11 intercostal vein;

contracting the deployable structure after the delivering of the energy, and

removing the endovascular catheter from the patient after the contraction of the deployable structure.

18 . A method for increasing splanchnic venous compliance in an alive human patient, comprising:

advancing a distal region of an endovascular catheter through a femoral vein access or internal a jugular vein of the human patient with retaining a proximal region of the endovascular catheter external to the human patient,

positioning distal portion of the endovascular catheter in a T9, T10, or T11 intercostal vein of the human patient;

expanding a deployable structure on the distal portion in the T9, T10 or T11 intercostal vein;

activating at least one conduct element on the deployable structure and detecting a physiologic response indicating activation of a greater splanchnic nerve proximate the deployable structure;

after the detection of the physiological response, activating the at least one conductive element on the deployable structure to deliver energy into the T9, T10 or T11 intercostal vein to irreversibly disable a greater splanchnic nerve proximate the azygos vein or the T9, T10 or T11 intercostal vein;

contracting the deployable structure, and

removing the conductive element from the patient after the contraction of the deployable structure.

19 . A method of treating an alive human patient diagnosed with heart failure, comprising:

advancing a distal region of an endovascular catheter through a femoral vein access or a jugular vein of the human patient with retaining a proximal region of the endovascular catheter external to the human patient,

advancing the distal region of the endovascular catheter through the femoral vein or the jugular vein and through a vasculature and into an azygos vein or a T9, T10, or T11 intercostal vein of the human patient, wherein the distal region includes a deployable structure carrying at least one energy delivery element;

expanding a deployable structure in the azygos vein or the T9, T10 or T11 intercostal vein;

activating the at least one energy delivery element on the deployable structure and detecting a physiologic response indicating activation of a greater splanchnic nerve proximate the deployable structure;

after the detection of the physiological response, activating an energy source disposed external to the patient and in operable communication with the at least one energy delivery element on the deployable structure;

delivering energy from the at least one energy delivery element to irreversible disable the greater splanchnic nerve proximate the azygos vein or the T9, T10 or T11 intercostal vein;

contracting the deployable structure, and

removing the endovascular catheter from the patient after the contraction of the deployable structure.

20 . The method of claim 19 , wherein the delivering the energy comprises delivering energy from a first side of the deployable structure and not from a second opposite side of the deployable structure.

21 . The method of claim 19 , wherein the delivering the energy comprises directing the energy laterally, relative to the azygos vein or the T9, T10 or T11 intercostal vein, towards the greater splanchnic nerve.

22 . The method of claim 19 , wherein the expanding the deployable structure causes the at least one of the energy delivery element to move towards a wall of the azygos vein or the T9, T10 or T11 intercostal vein.

23 . The method of claim 22 , further comprising distending a wall of the azygos vein or the T9, T10 or T11 intercostal vein by expanding the deployable structure.

Assignments (3)

Continuity (7)

References Cited (400)