Methods and devices for endovascular ablation of a splanchnic nerve
Inventors
Panescu, Dorin • Wu, Andrew • ENGELMAN, Zoar Jacob • Gelfand, Mark • Leung, Mark S. • Levin, Howard
Assignees
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Publication Number
US-11712296-B2
Publication Date
2023-08-01
Expiration Date
Abstract
Systems, devices, and methods for transvascular ablation of target tissue. 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 patent describes endovascular/transvascular ablation systems and methods for treating heart failure, including HFpEF, and hypertension by ablating thoracic splanchnic nerves. In particular, the methods ablate a greater splanchnic nerve or a greater splanchnic nerve root to increase splanchnic venous blood capacitance.
The approach advances an elongate medical device into an azygos vein and then advances an ablation element from the azygos vein into a T9, T10, or T11 intercostal vein. Energy is delivered from the ablation element to create an ablative lesion that ablates a portion of the greater splanchnic nerve or the greater splanchnic nerve root.
The patent further describes forming a lesion with a length in a range of 5 to 20 mm and focuses on lesion geometry that can be continuous circumferential or partially circumferential. It includes device and energy delivery features intended to provide safer and more predictable ablation near small thoracic vasculature, with temperature monitoring to avoid overheating or boiling and with optional stimulation-based electrode features for targeting and confirmation.
Claims Coverage
The independent claim is directed to a method of ablating a greater splanchnic nerve or greater splanchnic nerve root to increase splanchnic venous blood capacitance, including advancing an elongate medical device from the azygos vein into a T9/T10/T11 intercostal vein, delivering energy, and creating a lesion of 5 to 20 mm in length. The dependent claims further refine the independent claim with stimulation-based positioning verification, partial circumferential energy delivery, continuous circumferential lesion formation, a minimum lesion depth, and a spatial constraint relative to the azygos ostium.
Ablation via azygos-to-T9/T10/T11 intercostal vein with lesion length 5–20 mm
Advancing an elongate medical device into an azygos vein and advancing an ablation element from the azygos vein into a T9, T10, or T11 intercostal vein; delivering energy when the ablation element is disposed in the T9, T10, or T11 intercostal vein; and creating a lesion having a length in a range of 5 to 20 mm, whereby creating the lesion ablates a portion of the greater splanchnic nerve or the greater splanchnic nerve root.
Stimulation-based electrode targeting/verification prior to ablation energy delivery
Prior to delivering energy, delivering stimulation energy to first and second stimulation electrodes to determine if the ablation element is in a target location within the intercostal vein.
Partial circumferential energy delivery
Delivering energy to the ablation element is performed from less than 100% of the element’s circumference.
Continuous circumferential lesion with length 5–20 mm
Creating a continuous circumferential lesion having a length between 5 and 20 mm.
Minimum lesion depth of at least 5 mm
Creating a lesion with a depth of at least 5 mm.
Placement constraint within up to 20 mm of the azygos ostium
Advancing the ablation element from the azygos vein into the T9, T10, or T11 intercostal vein by maintaining its position from the ostium of the azygos vein to within up to 20 mm of the ostium.
Across the independent claim and its dependent refinements, the coverage centers on an endovascular pathway (azygos vein to T9/T10/T11 intercostal veins) for ablating a portion of the greater splanchnic nerve or greater splanchnic nerve root to increase splanchnic venous blood capacitance, with lesion length 5 to 20 mm. Dependent features add stimulation-based electrode targeting/verification, constrain the circumferential extent of energy delivery, define continuous circumferential lesion formation, require a minimum lesion depth, and constrain placement relative to the azygos ostium.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Treatment of heart failure (including HFpEF) by ablating thoracic splanchnic nerves to increase splanchnic venous blood capacitance.
Treatment of hypertension by ablating thoracic splanchnic nerves to increase splanchnic venous blood capacitance.
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