Expandable Prosthetic Heart Valve Radial Stent Adaptation
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Solution Overview
Problem
Traditional prosthetic heart valves are not expandable, requiring frequent invasive surgeries as patients grow, leading to patient discomfort and increased medical costs.
Innovation Solution
A prosthetic heart valve with a ring-shaped stent and leaflet structure that can be contracted or expanded radially, allowing it to adapt to the growing heart without replacement, featuring a mesh structure for size adjustment and a covering layer to prevent tissue contact.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If a traditional non-expandable prosthetic heart valve is implanted, then the valve provides stable structural support and reliable valve function, but the valve cannot adapt to heart growth requiring frequent invasive replacement surgeries
Solution Approach 1:
The stent is designed with a mesh structure that enables dynamic expansion from a compressed delivery state to an expanded implanted state, and potentially to intermediate states. The mesh configuration allows radial expansion while maintaining axial positioning, enabling the valve to adapt to growing hearts without requiring surgical replacement
Solution Approach 2:
The valve diameter parameter can be changed post-implantation through expansion mechanisms. The mesh stent structure allows controlled increase in radial dimension to match heart growth, transforming the valve from a fixed-size component to an adjustable-size implant that grows with the patient
2Reliability
If frequent invasive replacement surgeries are performed, then the patient receives updated valve functionality, but the patient experiences pain and medical costs increase
Solution Approach 1:
The valve is designed with expandability capability built in from the beginning, anticipating future heart growth. This preliminary design feature eliminates the need for subsequent replacement surgeries, as the single initial implant can be expanded to accommodate growth throughout childhood and adolescence
Solution Approach 2:
The expandable valve serves multiple functions across different time periods: it provides initial valve function at implantation, adapts to accommodate heart growth, and potentially serves as a long-term permanent implant. This multi-functionality across developmental stages replaces what would otherwise require multiple separate surgical interventions
3Adaptability or versatility
If the stent is made expandable with a mesh structure, then the valve can adapt to heart growth, but the structural complexity and manufacturing difficulty increase
Solution Approach 1:
The stent is divided into multiple mesh cells arranged in a pattern that enables controlled expansion. Each mesh cell acts as an independent structural unit that can deform during expansion, allowing the overall structure to change diameter while maintaining structural integrity through the repeating modular pattern
Solution Approach 2:
The mesh structure functions as a flexible framework that can transition between compressed and expanded states. The thin-walled mesh configuration provides sufficient structural support in the expanded state while allowing significant compression for delivery through catheters, balancing flexibility with structural requirements
4Reliability
If the leaflet structure is oversized relative to the stent, then the valve forms a more functional structure with excessive portions freely sagging, but the device complexity increases
Solution Approach 1:
The oversized leaflet structure automatically adjusts to the correct functional configuration through gravity and blood flow forces. The excessive portions freely sag to appropriate positions without requiring complex mechanical guidance or control mechanisms, allowing the structure to self-organize into a functional valve configuration
Solution Approach 2:
The leaflet structure is designed to be dynamic rather than rigidly fixed, allowing the excessive portions to move and sag freely to form functional valve cusps. This dynamic configuration enables the leaflets to adapt to different pressure conditions and flow patterns while maintaining reliable valve function
Data Source
AI summary
Disclosed is a prosthetic heart valve, wherein the prosthetic heart valve comprises: a ring-shaped stent, comprising: a mesh structure which allows the stent to be contracted or expanded in a radial direction; and a leaflet structure, comprising a plurality of leaflets, each leaflet is attached to the stent and has a first portion disposed within the stent and a second portion being wrapped to an outer circumferential side of the proximal end of the stent. With a growth of the heart, the stent can be expanded after the prosthetic heart valve is anchored, to allow the prosthetic heart valve to operate in different states, and under at least one of the different states, each leaflet has an excessive portion freely sagging to a position away from the stent along a direction from the distal end to the proximal end, to allow the stent to form a more functional valve.