Prosthetic Valve Leaflet Thickness Control via Dip Casting and Humidity Curing
Find Innovative SolutionsGenerate Solutions
Solution Overview
Problem
Current techniques for manufacturing prosthetic heart valves with artificial polymeric leaflets are not suitable for large-scale production and lack efficient methods for forming and integrating leaflets with the valve frame, leading to inconsistencies in leaflet thickness and performance.
Innovation Solution
The use of an environmental humidity chamber (EHC) for partial curing of liquid polymer during the manufacturing process, combined with a dip casting method to form leaflets directly on the valve frame, and the application of an identifier for traceability and process control, ensures consistent leaflet thickness and integration with the frame.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Manufacturing precision
If conventional manufacturing techniques are used for prosthetic heart valves, then manual assembly and traditional polymer processing methods can be applied, but the manufacturing precision and consistency of leaflet thickness are poor
Solution Approach 1:
The patent applies preliminary action by pre-coating the valve frame with a polymer layer before dip casting the leaflets. This undercoat layer is applied in advance to ensure uniform thickness and proper adhesion, resolving the thickness consistency issue before the main manufacturing step occurs.
Solution Approach 2:
The patent introduces an intermediary undercoat layer between the valve frame and the leaflet polymer. This intermediate layer acts as a mediator that ensures uniform thickness distribution and proper bonding, solving the manufacturing precision problem while maintaining ease of manufacture through a systematic multi-step process.
2Manufacturing precision
If polymeric leaflets are formed by conventional coating methods, then traditional polymer processing can be used, but the leaflet thickness and uniformity are inconsistent
Solution Approach 1:
The patent implements continuity of useful action by using dip casting followed by immediate partial curing in the humidity chamber, then proceeding directly to final curing in the oven without interruption. This continuous process ensures uniform thickness while optimizing time efficiency through seamless transition between manufacturing stages.
Solution Approach 2:
The patent applies parameter changes by controlling humidity levels in the chamber during partial curing, then transitioning to elevated temperature for final curing. This systematic change in environmental parameters (humidity then temperature) ensures consistent leaflet thickness and proper polymer crosslinking, resolving the uniformity issue while managing cycle time through optimized parameter transitions.
3Reliability
If polymeric leaflets are formed by conventional coating methods, then traditional processing can be used, but the leaflets show poor adhesion to the valve frame
Solution Approach 1:
The patent applies preliminary action by pre-coating the valve frame with polymer to create an undercoat layer before forming the leaflets. This preliminary step ensures proper adhesion by creating a bonded interface between the frame and the leaflet polymer, resolving the reliability issue while the added step is offset by the elimination of separate adhesion treatments.
Solution Approach 2:
The patent merges the adhesion function and the structural function into a single integrated undercoat layer. This combined layer simultaneously provides bonding to the frame and serves as the base for the leaflets, improving reliability while reducing overall process complexity by eliminating separate adhesion steps.
4Productivity
If manual assembly methods are used for prosthetic valves, then traditional surgical techniques can be applied, but the productivity and scalability are limited
Solution Approach 1:
The patent replaces manual mechanical assembly with an automated dip casting process. The valve frame is dipped into the polymer solution in a controlled manner, and the leaflets are formed automatically through the dip casting and curing process. This substitution dramatically improves productivity and scalability while maintaining manufacturing precision through consistent process parameters.
Solution Approach 2:
The patent uses parameter changes (dip depth, dip speed, curing temperature, humidity levels) to control leaflet formation and integration consistency. By systematically controlling these parameters, the process achieves high manufacturing precision while being fully automated for improved productivity and scalability.
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
This approach results in prosthetic heart valves with consistent leaflet thickness and improved manufacturability, allowing for precise control of the manufacturing process and traceability throughout the production stages, enhancing the reliability and quality of the valves.
Implementation Method 1
The use of an environmental humidity chamber (EHC) for partial curing of liquid polymer during the manufacturing process
Implementation Method 2
combined with a dip casting method to form leaflets directly on the valve frame
Data Source
Figure 1
Figure 2A~2B
Figure 3A
AI summary
Improved prosthetic heart valves and their methods of manufacture are described. An environmental humidity chamber can be used in the methods of valve leaflet manufacture for a first phase of curing. In some instances, the methods of manufacturing a polymeric valve prosthesis can include applying an identifier to the prothesis. The identifier can be covered by polymer but remain readable through the polymer.