Polymeric Prosthetic Valve Leaflets for Catheter Delivery Durability
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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 creates creases and crimps susceptible to calcification, and there is a need for improved implantable valves with longer lifespan and reduced stress on polymer leaflets.
Innovation Solution
Development of prosthetic valves with artificial polymeric leaflets and expandable/contractable frames, manufactured using dip casting and electrospinning processes, allowing for minimally invasive catheter delivery and reduced stress on the polymer, eliminating the need for suturing or molding.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If bioprosthetic valves are implanted through catheter-based delivery, then minimally invasive implantation is achieved, but the biological tissue leaflets develop creases and crimps that accelerate calcification and reduce lifespan
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 extending valve lifespan without sacrificing minimally invasive implantation capability
Solution Approach 2:
The patent uses composite construction with polymeric leaflets integrated with a support structure. This composite approach combines the flexibility needed for catheter delivery with the durability required to prevent calcification and extend lifespan, resolving the contradiction between ease of operation and reliability
2Volume of moving object
If bioprosthetic valves are reduced to smaller cross-sectional size for catheter delivery, then minimally invasive implantation is enabled, but stress on the tissue leaflets increases and accelerates degradation
Solution Approach 1:
The patent changes the material parameter from biological tissue to polymeric material with superior mechanical properties. The polymeric leaflets have higher strength-to-weight ratios and elastic recovery characteristics that allow them to withstand compression during catheter delivery and expand to full size without permanent deformation or excessive stress
Solution Approach 2:
The patent employs a dynamic support structure that transitions from a compressed state during delivery to an expanded functional state after implantation. This dynamic behavior allows the valve to be delivered through a catheter in a reduced size while maintaining the strength and structural integrity needed to resist stress during operation
3Reliability
If polymeric leaflets are used instead of biological tissue, then durability and stress resistance are improved, but manufacturing complexity increases
Solution Approach 1:
The patent merges the leaflet formation and support structure integration into a single manufacturing process. The polymeric leaflets are formed directly on or integrated with the support structure through dip casting or electrospinning, eliminating separate assembly steps and reducing manufacturing complexity despite the advanced materials used
Solution Approach 2:
The patent replaces traditional mechanical manufacturing methods (cutting, suturing, molding) with chemical and electrostatic processes (dip casting, electrospinning). These substitution processes allow for seamless integration of polymeric leaflets with support structures, reducing the number of manufacturing steps and improving durability through more uniform material properties
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 offer improved durability and reduced stress, enabling easier contraction for delivery and minimizing long-term degradation, while maintaining structural support comparable to biological tissue.
Implementation Method 1
utilize a dip casting or dipping process that involves immersing some or all of an element of the prosthetic valve (or used in formation of the prosthetic heart valve) into a wet polymer to form a coating of polymer thereon
Implementation Method 2
Many of these embodiments utilize electrospinning polymer onto a frame to form the valve
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.