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Publication Number
US-11938291-B2
Publication Date
2024-03-26
Expiration Date
Abstract
A device for reducing pressure within a lumen includes a reservoir structured for holding a fluid therein, an injection port in fluid communication with the reservoir, a compliant body structured to expand and contract upon changes in pressure, and a conduit extending between and fluidly coupling the reservoir and the compliant body. The fluid may be a compressible or a noncompressible fluid.
Core Innovation
A pulmonary hypertension therapy device/system reduces pulsatile load and peak pressure by implanting a gas-filled compliant body in the pulmonary artery that compresses during systole and expands during diastole. The compliant body is coupled to fluid/gas pressure equalization via a remote reservoir in fluid communication with the compliant body through transvascular and extravascular conduits. An injection port enables filling and pressure adjustments.
In a described active embodiment, a controllable pulsatile pump provides inflation/deflation to the gas-filled compliant body and can be controlled by a CPU, optionally with pressure sensing and telemetry. The system discusses use of compressible gas and also alternative use of a non-compressible fluid within the disclosed pressure-reducing architecture. Anchoring and implantation concepts include a deployed anchor that contacts an inner wall of the pulmonary artery to anchor a balloon coupled to a conduit.
The document reports bench-top pulmonary circulation testing showing about 15% peak pressure reduction with minimal mean pressure change. The described mechanism relates the reduction to increased effective compliance and a slowed pulse wave velocity and/or reduced contribution from reflected waves, corresponding to changes in elastelance/compliance relationships (ΔV/ΔP and ΔP/ΔV). In the method context, implantable components can be accessed by leaving an implanted anchor in the pulmonary artery while removing the conduit and balloon.
Claims Coverage
The partial content includes two independent claims. Each independent claim centers on an anchor-deployed balloon-and-conduit arrangement in the pulmonary artery with a reservoir-coupled pressurizing fluid that moves between the balloon and the reservoir across pressure changes, followed by removal of the conduit and balloon while keeping the anchor in place.
Anchor-deployed balloon with reservoir-coupled pressure-responsive state transitions
Accessing an anchor implanted in an expanded, deployed state that contacts an inner wall of the pulmonary artery to anchor a balloon coupled to a conduit, where the balloon transitions between an expanded state and a contracted state responsive to pressure change in the pulmonary artery, and where fluid moves towards a reservoir coupled to the conduit when the balloon transitions to the contracted state and fluid moves towards the balloon to expand the balloon to the expanded state.
Remove conduit and balloon while anchor remains
Removing the conduit and the balloon while the anchor remains in the pulmonary artery.
Sheath advancement and anchor deployment to anchor the balloon and conduit
Advancing a distal region of a sheath into a pulmonary artery of a patient with an anchor disposed therein, retracting the sheath to transition the anchor from a contracted, delivery state to an expanded, deployed state such that the anchor contacts an inner wall of the pulmonary artery to anchor a balloon coupled to a conduit within the pulmonary artery.
Pressurize balloon so fluid moves between balloon and reservoir across pulmonary artery pressure changes
Pressurizing the balloon with a fluid such that the balloon transitions between an expanded state and a contracted state responsive to pressure change in the pulmonary artery, wherein the fluid moves towards a reservoir coupled to the conduit when the balloon transitions to the contracted state and the fluid moves towards the balloon to expand the balloon to the expanded state.
Across both independent claims, the inventive approach is to deploy an anchor in the pulmonary artery to support a balloon-coupled conduit whose balloon state transitions between expanded and contracted states responsive to pulmonary artery pressure, with fluid moving between the balloon and a reservoir coupled to the conduit, and then to remove the conduit and balloon while leaving the anchor in place.
Stated Advantages
Reduces pulsatile load and peak pressure (about 15% peak pressure reduction reported).
Minimal mean pressure change.
Increases effective compliance.
Slows pulse wave velocity and/or reduces reflected-wave contribution (as discussed in the document).
Documented Applications
Pulmonary hypertension therapy using implantable components in the pulmonary artery with pressure-reducing pulsatile behavior.
Accessing implantable components for treating pulmonary hypertension by leaving an implanted anchor in the pulmonary artery and removing the conduit and balloon.
Using implantable components for treating pulmonary hypertension by advancing a sheath, deploying an anchor to contact an inner wall, pressurizing a balloon responsive to pulmonary artery pressure, and removing the conduit and balloon while the anchor remains.
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