Devices, systems, and methods for treatment of heart failure by splanchnic nerve ablation
Inventors
Levin, Howard • Gelfand, Mark • ENGELMAN, Zoar Jacob • Panescu, Dorin • Leung, Mark S.
Assignees
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Publication Number
US-11801092-B2
Publication Date
2023-10-31
Expiration Date
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.
Core Innovation
The invention relates to treating heart failure, including HFpEF, by endovascular ablation of thoracic splanchnic nerves including greater splanchnic nerve, lesser/least splanchnic nerves, and splanchnic nerve roots. The treatment is delivered via venous access to thoracic venous spaces including an azygos vein space and/or an intercostal vein corresponding to T8, T9, T10, or T11.
The system concept includes an endovascular ablation catheter having an ablation element and an intravascular imaging element. Tissue in proximity to the ablation catheter is imaged using the imaging element, and ablative energy is delivered using the ablation element when the catheter is located in the azygos vein space or intercostal vein to ablate the thoracic splanchnic nerve.
The hemodynamic rationale is to increase splanchnic venous capacitance and venous reservoir and reduce pulmonary congestion and blood pressure to improve dyspnea and exercise capacity. The catheter can further include optional stimulation elements and stimulation electrodes for proximity or efficacy confirmation.
A lung-monitoring concept is used to inhibit or pause ablation when lung tissue is too close, including lung-sparing delivery rules based on distance thresholds and lung safe distance thresholds.
Claims Coverage
The partial content provides one independent method claim. The independent claim includes three main inventive features related to endovascular delivery to specified thoracic venous spaces, intravascular imaging of tissue near the catheter, and delivering ablative energy to ablate the thoracic splanchnic nerve when positioned in the specified venous space.
Endovascular delivery to T8-T11 azygos or intercostal vein space with ablation catheter
The method endovascularly delivers an ablation catheter to one or both of a T8, T9, T10, or T11 azygos vein space or a T8, T9, T10, or T11 intercostal vein, where the ablation catheter comprises an ablation element and an intravascular imaging element.
Intravascular imaging of tissue in proximity to the catheter
The method images tissue in proximity to the ablation catheter using the intravascular imaging element.
Ablative energy delivery when positioned in the selected thoracic venous space to ablate the thoracic splanchnic nerve
The method delivers ablative energy using the ablation element when the ablation catheter is in one or both of the T8, T9, T10, or T11 azygos vein space, or the T8, T9, T10, or T11 intercostal vein, to ablate the thoracic splanchnic nerve.
Overall, the claim coverage is directed to endovascular catheter delivery to specific thoracic venous spaces, coupled with intravascular imaging of nearby tissue and ablative energy delivery to ablate the thoracic splanchnic nerve when the catheter is positioned in the specified vein space.
Stated Advantages
Improves dyspnea and exercise capacity by reducing pulmonary congestion and blood pressure through increased splanchnic venous capacitance and venous reservoir.
Documented Applications
Treatment of heart failure, including HFpEF, using endovascular ablation of thoracic splanchnic nerves via azygos vein space or intercostal vein access.
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