Intravascular Shield for Pulmonary Vein Isolation
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Solution Overview
Problem
Current treatments for Heart Failure with preserved Ejection Fraction (HFpEF) are inadequate, as they fail to effectively address the underlying atrial dysfunction and pulmonary congestion, leading to increased pulmonary pressures and right-sided heart failure, with existing intra-atrial shunting devices not fully alleviating lung congestion or restoring LA functionality.
Innovation Solution
An implantable cardiac device is designed to isolate pulmonary pressures from left atrial pressures by restricting fluid flow from the left atrium into the pulmonary veins while allowing flow from the lungs to the left atrium, using an intravascular shield or one-way valve positioned in the pulmonary veins, which can be expandable and configured to engage the left atrium, thereby reducing pulmonary congestion and enhancing cardiac output.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Stress or pressure
If intra-atrial shunting devices are used to reduce left atrial pressure, then left atrial pressure is reduced, but pulmonary congestion is not fully alleviated and lung gas diffusion is impaired
Solution Approach 1:
The device segments the pulmonary vein ostium into multiple zones using radial partitions or baffle structures, creating separate flow channels that allow selective passage of blood while preventing congestion in specific pulmonary vein segments
Solution Approach 2:
The device implements local flow regulation by creating different flow characteristics in different regions of the pulmonary vein ostium, allowing preferential flow toward the left atrium while restricting flow to congested pulmonary vein segments
2Stress or pressure
If existing shunting devices are deployed to treat HFpEF, then some pressure relief is achieved, but right-sided heart failure progression is not prevented
Solution Approach 1:
The device performs preliminary flow direction control by guiding blood flow toward the left atrium before it can contribute to pulmonary congestion and right-sided heart failure, preventing the harmful cascade before it occurs
Solution Approach 2:
The device acts as an intermediary structure within the pulmonary vein ostium that mediates between the left atrium and pulmonary veins, controlling flow distribution to protect both the pulmonary circulation and right heart
3Stress or pressure
If LA shunting is performed to reduce LA pressure, then LA pressure decreases, but cardiac output is not maximized and may be reduced
Solution Approach 1:
The device creates dynamic flow conditions by utilizing pressure gradients and flow velocity variations to preferentially direct blood toward the left ventricle during phases that maximize cardiac output, adapting flow distribution to cardiac cycle dynamics
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
The device effectively minimizes retrograde flow into pulmonary veins, reduces pulmonary congestion, and maximizes forward flow into the left ventricle, improving cardiac output and addressing the challenges of HFpEF, pulmonary hypertension, and mitral regurgitation, while also being beneficial for patients with Heart Failure with Reduced Ejection Fraction (HFrEF) and atrial fibrillation.
Implementation Method 1
The intravascular shield can comprise a one-way valve sized and configured to be positioned over or within a pulmonary vein
Data Source
AI summary
A system or device for isolating pulmonary pressure from left atrial pressure and/or improving cardiac output. The device may be an implantable cardiac device comprising an intravascular shield. The system may comprise an intravascular shield and a trans-septal delivery sheath. The intravascular shield can be sized and configured to be positioned in a pulmonary vein or a left atrium to restrict fluid flow from the left atrium through one or more pulmonary veins to the lungs while allowing fluid flow from the lungs through the one or more pulmonary veins to the left atrium. The trans-septal delivery sheath can be configured to contain the intravascular shield in a collapsed configuration and deliver the intravascular shield to the left atrium.