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Publication Number
US-11534631-B2
Publication Date
2022-12-27
Expiration Date
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 disclosed invention relates to pulmonary artery denervation for treating secondary pulmonary hypertension. It includes a pulmonary artery manipulation device configured to impair sympathetic nerve activity, including embodiments in which the device emits an unfocused ultrasound beam. The approach aims to select patients for denervation based on pulmonary vascular resistance (PVR) behavior rather than applying denervation broadly.
A patient selection process is performed by obtaining information regarding a patient’s PVR before and after a selection treatment. The method refrains from providing pulmonary artery denervation if the determined PVR is below 2.5 Wood units or if the PVR decreases in response to the selection treatment. In addition, denervation is provided only if the PVR is above 2.5 Wood units and essentially no change in PVR is observed in response to the selection treatment.
The document further grounds eligibility determination using hemodynamic classification consistent with WHO pulmonary hypertension groups. It references WHO group II/III/IV/V pulmonary hypertension and uses pressure-based criteria such as pulmonary capillary wedge pressure (PCWP) and left ventricular end-diastolic pressure (LVEDP) in the dependent claim refinements. The selection treatment is defined by explicitly enumerated therapeutic modalities, and the selection concept is tied to distinguishing reactive versus essentially non-reactive pulmonary hypertension through PVR response.
Claims Coverage
The independent claims identify two core inventive methods with a shared eligibility logic based on PVR measured before and after a selection treatment. Across the independent claims, the inventive features focus on refraining from denervation when PVR is below threshold or decreases after selection treatment and treating pulmonary hypertension with denervation only when PVR is above threshold and shows essentially no change after selection treatment; dependent claim refinements further specify WHO group limitations, additional pressure measurements, and the pulmonary artery manipulation device characteristics.
Patient suitability determination using PVR response to selection treatment
Obtaining information regarding a pulmonary vascular resistance (PVR) of the patient before and after a selection treatment; and refraining from providing the pulmonary artery denervation treatment if the determined PVR is below 2.5 Wood units or if the PVR of the patient decreases in response to the selection treatment.
Ameliorating or treating pulmonary hypertension with conditional pulmonary artery denervation based on PVR response
Obtaining information regarding a pulmonary vascular resistance (PVR) of the patient before and after a selection treatment; and treating the patient with a pulmonary artery manipulation device to provide pulmonary artery denervation only if the determined PVR is above 2.5 Wood units and if essentially no change in the PVR is observed in response to the selection treatment, thereby ameliorating and/or treating the pulmonary hypertension of the patient.
Both independent claims require pre- and post-selection PVR determination and use PVR thresholding and PVR response (decrease vs essentially no change) to decide whether to refrain from or provide pulmonary artery denervation, thereby targeting patient suitability and treatment of pulmonary hypertension.
Stated Advantages
Improves patient selection for pulmonary artery denervation by refraining from treatment when PVR is below 2.5 Wood units or decreases in response to the selection treatment.
Ameliorates and/or treats pulmonary hypertension by providing pulmonary artery denervation only when PVR is above 2.5 Wood units and essentially no change in PVR is observed after selection treatment.
Documented Applications
Treating pulmonary hypertension in a patient in need thereof using pulmonary artery denervation selected based on PVR response to a selection treatment.
Secondary pulmonary hypertension treatment via pulmonary artery denervation using a pulmonary artery manipulation device that impairs sympathetic nerve activity.
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