Transcatheter Prosthetic Valves With Polymeric Leaflets Against Calcification
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Solution Overview
Problem
Transcatheter implantation of bioprosthetic heart valves faces challenges due to the finite life span of biological tissue leaflets, exacerbated by catheter-based implantation, which causes creases and crimps susceptible to calcification, and existing methods do not adequately address the need for improved manufacturability and longevity of prosthetic valves.
Innovation Solution
The development of prosthetic heart valves with artificial polymeric leaflets and expandable frames that can be contracted for minimally invasive delivery, utilizing dip casting and electrospinning techniques to form polymer coatings, and incorporating materials like siloxane polyurethane urea (SiPUU) for enhanced durability and stress resistance.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If bioprosthetic valves are implanted via catheter, then minimally invasive implantation is achieved, but the biological tissue leaflets develop creases and crimps that are susceptible to calcification and reduce longevity
Solution Approach 1:
The patent changes the material parameter from biological tissue to polymeric material, which fundamentally alters the mechanical properties. The polymeric leaflets maintain flexibility for catheter delivery while resisting crease formation and calcification, thus resolving the contradiction between minimally invasive implantation and long-term reliability
Solution Approach 2:
The patent employs composite construction with a frame structure supporting polymeric leaflets. This composite design allows the frame to provide structural integrity during delivery and expansion, while the polymeric leaflets provide durable, calcification-resistant valve surfaces, addressing both the delivery method and longevity concerns
2Reliability
If valve leaflets are made from biological tissue, then tissue-based valve function is achieved, but the finite life span and susceptibility to calcification limit durability
Solution Approach 1:
The patent fundamentally changes the material composition from biological tissue to synthetic polymeric materials. This parameter change eliminates the finite life span and calcification susceptibility inherent in biological tissues while maintaining the essential valve function, thereby extending the operational duration significantly
Solution Approach 2:
The patent replaces expensive, long-lived biological tissue with more affordable synthetic polymeric materials that offer comparable or superior durability. The polymeric leaflets resist degradation and calcification better than biological tissue, providing a cost-effective solution with extended service life
3Volume of moving object
If valve size is reduced for catheter delivery, then minimally invasive implantation is enabled, but creases and crimps in the leaflets increase susceptibility to calcification
Solution Approach 1:
The patent changes the material parameter from biological tissue to polymeric material, which has superior elastic recovery properties. This allows the valve to be compressed to small delivery sizes without creating permanent creases or crimps that would lead to calcification, thus resolving the contradiction between compact delivery and resistance to harmful factors
Solution Approach 2:
The patent employs thin, flexible polymeric leaflets that can be elastically deformed during catheter delivery and then recover their original shape upon deployment. This flexibility allows size reduction for delivery while preventing permanent structural damage and calcification, addressing both delivery and durability requirements
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 prosthetic valves with polymeric leaflets and expandable frames offer improved longevity and reduced stress, allowing for easier contraction and expansion, minimizing long-term degradation and calcification, while enabling minimally invasive implantation and automated manufacturing processes.
Implementation Method 1
The frame can be dipped in a wet polymer to form a polymer coating on the frame, and the polymer coating can be cured to form a valvular body having two or more leaflets
Implementation Method 2
The polymer coating can be cured, for example, with UV irradiation or otherwise, to form the valvular body
Data Source
Figure 1A
Figure 1B
Figure 2A~2B
AI summary
Improved prosthetic valves, their methods of manufacture, and systems and devices for manufacturing the valves are described. The prosthetic valves can be configured for transcatheter implantation. The prosthetic valves can have artificial leaflets. The prosthetic valves can be manufactured in numerous ways, such as by polymeric dipping processes and/or electrospinning. Sponge-like polymers for valves and other medical devices are also disclosed.