Methods and devices for endovascular ablation of a splanchnic nerve

Inventors

Panescu, DorinWu, AndrewENGELMAN, Zoar JacobGelfand, MarkLeung, Mark S.

Assignees

Axon Vascular IncCoridea LLC

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Publication Number

US-11844569-B1

Patent

Publication Date

2023-12-19

Expiration Date


Abstract

Systems, devices, and methods for transvascular ablation of target tissue are disclosed herein. The devices and methods may, in some examples, be used for splanchnic nerve ablation to increase splanchnic venous blood capacitance to treat at least one of heart failure and hypertension. For example, the devices disclosed herein may be advanced endovascularly to a target vessel in the region of a thoracic splanchnic nerve (TSN), such as a greater splanchnic nerve (GSN) or a TSN nerve root. Also disclosed are method of treating heart failure, such as HFpEF, by endovascularly ablating a thoracic splanchnic nerve to increase venous capacitance and reduce pulmonary blood pressure.

Core Innovation

The disclosed invention provides a method of ablating a greater splanchnic nerve by inserting a catheter into a vascular lumen of a subject and guiding the catheter towards a location proximate to the greater splanchnic nerve at a location adjacent a T9, T10, or T11 vertebra. The guidance is performed while the catheter is in one or both of an azygos vein or an intercostal vein, so that an electrode-containing needle assembly is positioned for nerve ablation at the target spinal level.

The vascular tissue of the one or both of the azygos vein or the intercostal vein is pierced with a needle assembly extending outwards from the catheter, wherein the needle assembly comprises one or more electrodes. Energy is then delivered to the greater splanchnic nerve with the one or more electrodes to ablate the greater splanchnic nerve when the catheter is in the location adjacent a T9, T10, or T11 vertebra while in the one or both of the azygos vein or the intercostal vein.

Additional aspects described in the disclosure include pre- and/or confirmatory stimulation and physiological response measurement for proximity verification and confirmation of interrupted nerve activity, as well as a radiographic marker to orient the catheter so the needle assembly aligns with the greater splanchnic nerve. The described embodiments also include a telescoping needle assembly deployed outward from an exit port and carrying one or more electrodes, enabling puncturing through the azygos vein or the intercostal vein at the target location adjacent a T9, T10, or T11 vertebra.

Claims Coverage

The claims coverage includes three independent method claims directed to ablating a greater splanchnic nerve using transvascular delivery from an azygos vein and/or an intercostal vein to a location adjacent a T9, T10, or T11 vertebra, with electrode-based energy delivery via an electrode-carrying needle assembly.

Catheter-guided transvenous targeting adjacent T9-T11

Inserting a catheter into a vascular lumen; guiding the catheter towards a location proximate to the greater splanchnic nerve at a location adjacent a T9, T10, or T11 vertebra while in one or both of an azygos vein or an intercostal vein.

Needle assembly with electrodes for transvenous piercing and ablation

Piercing vascular tissue of the one or both of the azygos vein or the intercostal vein with a needle assembly extending outwards from the catheter, wherein the needle assembly comprises one or more electrodes; delivering energy to the greater splanchnic nerve with the one or more electrodes to ablate the greater splanchnic nerve when the catheter is in the location adjacent a T9, T10, or T11 vertebra while in the one or both of the azygos vein or the intercostal vein.

Ablation catheter delivery to vein adjacent T9-T11 and telescoping needle deployment

Delivering an ablation catheter to one or both of an azygos vein or an intercostal vein at a location adjacent a T9, T10, or T11 vertebra; deploying a telescoping needle assembly outward from an exit port of the ablation catheter and puncturing through the azygos vein or the intercostal vein with the telescoping needle assembly, the needle assembly comprising one or more electrodes; delivering energy from the one or more electrodes to ablate the greater splanchnic nerve when the ablation catheter is in the location adjacent a T9, T10, or T11 vertebra.

First and second telescoping members carrying electrodes

Deploying a telescoping needle assembly outward from an exit port of the ablation catheter and puncturing through the azygos vein or the intercostal vein with the telescoping needle assembly, the telescoping needle assembly comprising first and second telescoping members, the deploying step causing the second member to extend from the first member, the second member carrying one or more electrodes thereon.

Pre- and confirmatory stimulation with physiological response measurement

Delivering stimulation energy to the greater splanchnic nerve before puncturing through the azygos vein or the intercostal vein and measuring a physiological response to determine whether the ablation catheter location is sufficiently close to ablate the greater splanchnic nerve during the energy delivering step; delivering confirmatory stimulation energy after ablation of the greater splanchnic nerve and measuring a physiological response change corresponding to that energy to confirm interrupted nerve activity.

Radiographic marker for catheter orientation aligning needle assembly

Using a radiographic marker on the catheter to orient an ablation catheter within one or both of the azygos vein or the intercostal vein so that the needle assembly is aligned with the greater splanchnic nerve.

Across the independent claims, the inventive approach is ablating the greater splanchnic nerve by transvascular placement of a catheter or ablation catheter adjacent T9-T11, piercing azygos and/or intercostal venous tissue using a needle assembly that carries one or more electrodes, including telescoping members, and delivering energy to ablate the nerve at the positioned adjacent vertebral level, with dependent refinements covering stimulation and physiological-response verification and radiographic marker-based orientation.

Stated Advantages

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