Polymeric Heart Valve Insert Structure for Radial Support
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Solution Overview
Problem
Existing prosthetic heart valves face challenges in radial support force due to the use of different materials for the valve frame and leaflets, leading to poor bonding and increased fabrication complexity, as well as potential fractures during injection molding.
Innovation Solution
A polymeric heart valve design incorporating a hollow cylindrical insert with axial and radial positioning structures, allowing one-time injection molding of the valve frame and leaflets, which enhances radial support and prevents displacement during molding, while optimizing the structural integrity and performance.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Strength
If different materials are used for valve frame and leaflets to improve radial support force, then radial support force is improved, but bonding quality deteriorates and fabrication complexity increases
Solution Approach 1:
The valve is divided into three main components: valve frame, valve leaflets, and insert. The insert is placed inside the valve frame to provide radial support, while the valve frame and leaflets are molded as an integrated unit. This segmentation allows different materials to be used for each component while simplifying the bonding process between frame and leaflets.
Solution Approach 2:
The insert acts as an intermediary element that provides radial support force to the valve frame. By placing the insert inside the valve frame during injection molding, the patent achieves improved radial support without requiring complex bonding between different materials for the frame and leaflets.
2Strength
If different materials are used for valve frame and leaflets to improve radial support force, then radial support force is improved, but bonding quality deteriorates
Solution Approach 1:
The valve is divided into three main components: valve frame, valve leaflets, and insert. The insert is placed inside the valve frame to provide radial support, while the valve frame and leaflets are molded as an integrated unit. This segmentation allows different materials to be used for each component while simplifying the bonding process between frame and leaflets.
Solution Approach 2:
The valve frame and valve leaflets are made from the same polymer material and are molded in one piece, ensuring homogeneous material properties and reliable bonding. The insert provides the necessary radial support, separating the support function from the bonding interface between frame and leaflets.
3Strength
If insert with positioning structures is added to improve radial support, then radial support and positioning accuracy are improved, but device complexity increases
Solution Approach 1:
The insert features localized positioning structures (axial positioning structures at the ends and radial positioning structures on the outer wall) that provide precise positioning only where needed. The rest of the insert maintains a simple hollow cylindrical shape, balancing positioning accuracy with structural simplicity.
Solution Approach 2:
The positioning structures on the insert automatically align and position the insert within the valve frame during injection molding without requiring external positioning mechanisms. The axial positioning structures engage with corresponding features in the valve frame, while radial positioning structures maintain proper radial alignment.
Data Source
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AI summary
Provided by the present disclosure are a polymeric heart valve and a preparation method therefor. The polymeric heart valve includes a plurality of valve leaflets and a valve frame. The valve frame is a hollow cylindrical structure and includes a first end and a second end; the first end is provided with a plurality of column peaks arranged at intervals in a circumferential direction, and plurality of column valleys are correspondingly formed. A count of the plurality of valve leaflets is consistent with a count of the plurality of column peaks. The plurality of valve leaflets are arranged in a center of the first end. The plurality of valve leaflets are sequentially connected to two adjacent column peaks in the circumferential direction. The polymeric heart valve further includes an insert, the insert is a hollow columnar structure matching the valve frame, and the insert includes a third end and a fourth end corresponding to the first end and the second end, respectively. The insert is suitable for being embedded in the valve frame in an axial direction. The plurality of valve leaflets and the valve frame are subjected to one-time injection molding, and the insert is embedded into the valve frame to become a whole when the valve frame and the plurality of valve leaflets are subjected to injection molding. According to the polymeric heart valve provided by the present disclosure, the radial supporting force of the valve frame is increased by optimizing the structure and the process, thereby improving valve performance, simplifying the preparation process, and improving the preparation efficiency.