Leaflet Augmenter With Pressure-Inflating Pouch for Regurgitation
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Solution Overview
Problem
Cardiac valves suffer from damage leading to regurgitation of blood from the ventricle to the atrium, which can cause heart failure, and existing devices are inadequate in preventing backflow.
Innovation Solution
A leaflet augmenter system with a flexible pouch and anchor is used to improve coaptation between valve leaflets, featuring various shapes and configurations to enhance leaflet support and alignment, including adjustable straps and stabilizers to resist pivoting, and delivery tools for precise placement.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If existing devices are used to prevent backflow through damaged valves, then some level of regurgitation prevention is achieved, but the devices are inadequate in fully preventing backflow
Solution Approach 1:
The pouch is designed to dynamically inflate during ventricular systole when pressure increases, and deflate during diastole when pressure decreases. This dynamic response allows the device to adapt to the changing hemodynamic conditions throughout the cardiac cycle, providing effective coaptation support only when needed during systole while maintaining valve function during diastole.
Solution Approach 2:
The device changes its physical state (inflated/deflated) in response to pressure parameter changes in the ventricle. The pouch transitions from a collapsed state during diastole to an inflated state during systole, thereby adjusting its coaptation function based on the physiological pressure conditions without requiring external control mechanisms.
2Reliability
If the pouch is anchored closer to the lip of the first leaflet, then the pouch can effectively coapt against the opposing leaflet during systole, but the anchor may interfere with normal leaflet motion
Solution Approach 1:
The anchor is positioned to provide just enough support to enable effective coaptation during systole without over-constraining the leaflet. The anchoring point is optimized to provide sufficient stability for pouch inflation and coaptation while allowing the leaflet to maintain its natural motion characteristics during both systole and diastole.
3Area of stationary object
If the pouch is made larger to improve coaptation surface area, then better sealing against the opposing leaflet is achieved, but the device complexity and potential interference with valve geometry increases
Solution Approach 1:
The pouch is designed with specific geometric configurations (rectangular, mitre-shaped, conical, pillow-shaped, rounded square, globular, pyramidal, or tetrahedral) that optimize the distribution of coaptation surface area. These shapes are selected to provide adequate sealing contact with the opposing leaflet while maintaining compatibility with the natural valve geometry and avoiding excessive complexity in the device structure.
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 system effectively reduces regurgitation by enhancing leaflet coaptation, improving valve function and preventing backflow, thereby mitigating the risk of heart failure.
Implementation Method 1
responsively to ventricular systole: the pouch inflates via the downstream opening
Data Source
AI summary
Apparatus, usable with a valve disposed between an atrium and a ventricle of a heart, the valve having a first leaflet (S) and at least one opposing leaflet (A,P). The apparatus comprises an augmenter (700) that comprises a flexible pouch (710) and an anchor (780). The pouch has an external surface, an interior, an outside, and a downstream opening that provides fluid communication between the interior and the outside of the pouch. The anchor is coupled to the pouch, and configured to anchor the pouch to the lip of the first leaflet by the anchor being anchored to the first leaflet. The anchoring is such that the downstream opening opens into the ventricle. Responsively to ventricular systole, the pouch inflates via the downstream opening, and the external surface coapts against the opposing leaflet(s).