Systems and methods for treating pulmonary hypertension

Inventors

Vollmers, Karl • Scandurra, John

Assignees

Aria CV Inc

Abstract

A system for treating heart disease, such as pulmonary hypertension or right heart failure, including an implantable component and external components for monitoring the implantable component is provided. The implantable component may include a compliant member, e.g., balloon, coupled to a reservoir via a conduit. Preferably, the compliant member is adapted to be implanted in a pulmonary artery and the reservoir is adapted to be implanted subcutaneously. The external components may include a clinical controller component, monitoring software configured to run a clinician's computer, a patient monitoring device, and a mobile application configured to run on a patient's mobile device.

Core Innovation

The invention provides a system for treating pulmonary hypertension that uses a balloon sized and shaped to be implanted in a pulmonary artery. The balloon is configured to expand and contract responsive to pressure changes in the pulmonary artery. A reservoir is in fluidic communication with the balloon, and a conduit fluidically couples the balloon and the reservoir.

The system further includes an implantable anchor configured to transition between a contracted state and an expanded deployed state for securing the balloon within the pulmonary artery. The implantable anchor is formed from a shape memory material and is configured to self-expand upon deployment within the pulmonary artery. The implantable anchor comprises a plurality of petals spaced around a circumference at a distal end of the implantable anchor, so that the deployed anchor secures the balloon within the pulmonary artery.

The disclosed architecture also includes external components and monitoring/control. An external clinical controller couples to the reservoir, and fluidic hardware provides introduction of fluid into the reservoir. A software-based monitoring system provides graphical user interface, alarms/thresholds, calculated hemodynamic metrics, and event logging, using sensor-generated parameter signals.

Claims Coverage

The partial content identifies two independent claims: one system claim and one method claim. Across these independent claims, the core inventive coverage centers on a pressure-responsive pulmonary artery balloon coupled to a reservoir via a conduit, secured by a shape-memory petal anchor that self-expands to contact the inner wall of the pulmonary artery.

The independent claims collectively require a pulmonary artery balloon that responds to pulmonary artery pressure changes, a reservoir connected to the balloon by a conduit, and a shape-memory implantable anchor with petal structures that self-expands to secure the balloon by contacting the pulmonary artery inner wall. The method claim focuses on deploying the petal anchor in the pulmonary artery to secure the balloon, while the system claim defines the overall implanted components arrangement.

Stated Advantages

Documented Applications