Method for treating secondary pulmonary hypertension

Inventors

GILAD, Rotem

Assignees

Sonivie Ltd

Abstract

Method for ameliorating secondary pulmonary hypertension in a patient including determining a pulmonary vascular resistance (PVR) of the patient suffering from secondary pulmonary hypertension; assessing a change in the PVR in response to a selection treatment; and treating the patient with a pulmonary artery manipulation device to provide pulmonary artery denervation if the patient is determined to suffer from fixed PH, thereby ameliorating the secondary pulmonary hypertension of the patient.

Core Innovation

The invention relates to methods for ameliorating secondary pulmonary hypertension in a patient by pulmonary artery denervation. The method includes determining a pulmonary vascular resistance (PVR) of the patient suffering from secondary pulmonary hypertension and assessing a change in the PVR in response to a selection treatment. The patient is treated with a pulmonary artery manipulation device to provide pulmonary artery denervation only if the determined PVR is above 2.5 Wood units and essentially no change in the PVR is obtained in response to the selection treatment.

The disclosure identifies secondary pulmonary hypertension as WHO groups II-V and describes underlying etiologies including left heart disease associated pulmonary hypertension, COPD-associated pulmonary hypertension, interstitial lung disease-associated pulmonary hypertension, chronic thromboembolic pulmonary hypertension, and connective tissue disease-associated pulmonary hypertension. Physiologic criteria are described using pulmonary capillary wedge pressure (PCWP) and left ventricular end-diastolic pressure (LVEDP) for classifying WHO group II involvement, and a hemodynamic selection logic is provided for distinguishing reactive versus fixed PH based on essentially no PVR change after the selection treatment.

In addition to patient selection, the method positions a pulmonary artery manipulation device in a target blood vessel within the pulmonary vasculature and impairs the activity of at least one sympathetic nerve, nerve fiber or neuron using the pulmonary artery manipulation device to denervate the target blood vessel. Amelioration is associated with decreasing PVR in at least one artery of the pulmonary vasculature and is described as including a smooth muscle tone reduction.

Claims Coverage

The independent claims define two method frameworks for ameliorating secondary pulmonary hypertension: one based on a PVR-threshold and essentially no change selection response criterion, and one based on identifying pre-capillary and post-capillary involvement followed by sympathetic-nerve impairment via a pulmonary artery manipulation device. Across the independent claims, the inventive features focus on denervating pulmonary vessels by impairing sympathetic nerve activity and selecting patients using PVR-based criteria.

The independent claims share the central approach of ameliorating secondary pulmonary hypertension through pulmonary artery denervation accomplished by impairing sympathetic nerve activity using a pulmonary artery manipulation device, with amelioration linked to decreasing PVR. The claims differ in selection criteria: one requires PVR above 2.5 Wood units and essentially no PVR change after a selection treatment, while the other requires identifying pre-capillary and post-capillary involvement prior to device-based denervation.

Stated Advantages

Documented Applications