Percutaneous Temporary Aortic Valve with Dynamic Occlusion
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Solution Overview
Problem
Existing temporary aortic valve devices struggle to effectively occlude the aorta during diastole while allowing adequate coronary flow, often leading to mechanical failure and inadequate protection against aortic regurgitation.
Innovation Solution
A novel percutaneous transcatheter temporary aortic valve featuring a cone-shaped membrane occlusion element that collapses during systole and expands during diastole to occlude the aorta, with a diastolic gap or opening that allows coronary filling while minimizing regurgitation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a temporary aortic valve device is used to occlude the aorta during diastole, then aortic regurgitation is reduced, but coronary flow may be insufficient
Solution Approach 1:
The occlusion element is designed to dynamically change its configuration between systole and diastole. During diastole, it expands to occlude the aorta and reduce regurgitation. During systole, it collapses to allow adequate coronary flow. This dynamic adaptation resolves the contradiction by providing both protection against regurgitation and sufficient coronary perfusion at different phases of the cardiac cycle.
Solution Approach 2:
The device utilizes the periodic nature of the cardiac cycle to alternately occlude and permit flow. The occlusion element expands during diastole to prevent regurgitation and collapses during systole to allow coronary filling. This periodic action enables the device to satisfy both requirements of regurgitation protection and coronary flow maintenance through rhythmic operation synchronized with heartbeats.
2Reliability
If the occlusion element expands fully during diastole to prevent regurgitation, then aortic regurgitation is minimized, but mechanical stress on the device increases
Solution Approach 1:
The occlusion element transitions from a static to a dynamic structure that actively collapses during systole and expands during diastole. This dynamic behavior reduces the mechanical stress accumulated during full expansion by periodically relieving tension through collapse, thereby improving mechanical durability while maintaining effective regurgitation protection during diastole.
Solution Approach 2:
The periodic expansion and collapse of the occlusion element synchronized with the cardiac cycle prevents continuous high mechanical stress. By collapsing during systole, the device relieves accumulated tension and avoids sustained loading that would lead to mechanical failure, thus enhancing durability while maintaining regurgitation protection during diastolic expansion.
3Quantity of substance
If a fixed gap size is provided in the occlusion element, then coronary flow is maintained, but aortic regurgitation protection is inadequate
Solution Approach 1:
The occlusion element replaces the fixed gap concept with a dynamic structure that changes its effective opening size based on the cardiac phase. During diastole, the element expands to provide occlusion with controlled regurgitation. During systole, it collapses to maximize coronary flow. This dynamic adaptation eliminates the compromise of fixed gap designs by providing optimal flow characteristics at different times.
Solution Approach 2:
Instead of a constant fixed gap, the device employs periodic changes in the occlusion element's configuration. During diastole, the element maintains a controlled opening for coronary perfusion. During systole, it collapses to maximize the effective gap for forward flow. This periodic modification of the gap size through dynamic operation resolves the contradiction between maintaining coronary flow and providing adequate regurgitation protection.
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 inhibits aortic regurgitation during diastole while maintaining coronary perfusion, reducing the risk of mechanical failure and improving hemodynamic support for patients with damaged aortic valves.
Implementation Method 1
Blood flow in the aorta may cause the flexible occluding membrane to alternate between an expanded occluding configuration and a collapsed lesser occluding configuration in synchrony with ventricular diastole and systole
Implementation Method 2
the flexible occluding membrane may be adapted to assume the expanded occluding configuration in response to blood flow in the aorta during ventricular diastole
Data Source
AI summary
Methods and apparatuses for regulating aortic regurgitation are provided. A catheter shaft is advanced through vasculature so that a flexible occluding membrane coupled to the catheter shaft is positioned within the aorta, typically the ascending aorta above the Sinus of Valsalva and coronary ostia. Blood flow in the aorta causes the flexible occluding membrane to alternate between an expanded occluding configuration while in diastole and a collapsed lesser occluding configuration is systole. The flexible occluding membrane thereby acts as a temporary aortic valve. The flexible occluding membrane is generally conical in shape, with the tip of the cone disposed closer to the aorta than the proximal rim. In diastole, blood flow expands the flexible occluding membrane so that the proximal rim apposes the inner wall of the aorta. The flexible occluding membrane will have one or more openings to allow perfusion of the coronary arteries in diastole.