Polymeric Heart Valve Leaflets with Composition Gradient
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Solution Overview
Problem
Current heart valve replacement methods using tissue-based valves are labor-intensive and variable in performance due to manual fixation and attachment processes, which can lead to inconsistencies in valve function.
Innovation Solution
A prosthetic heart valve with polymeric leaflets featuring a composition gradient of two or more polymers, where each leaflet has a root portion coupled to a base and an edge portion that coapts with other leaflets, reducing the need for sutures and enhancing durability and hemodynamic performance.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If tissue-based valves are used with manual fixation and attachment processes, then the valves can be constructed with biological tissue, but the manufacturing process becomes labor-intensive and time-consuming with variability in performance
Solution Approach 1:
The patent replaces manual mechanical fixation and attachment processes with a molded polymeric structure that integrates the valve leaflets and supporting framework as a single piece. This eliminates the need for separate fixation steps and manual assembly, thereby improving manufacturing efficiency while ensuring consistent performance through automated molding processes.
Solution Approach 2:
The patent combines multiple components (valve leaflets, supporting framework, and fixation elements) into a single integrated polymeric structure. This merging of components eliminates the need for separate assembly steps and reduces manufacturing variability, directly addressing both productivity and reliability concerns.
2Ease of manufacture
If glutaraldehyde fixation and suture attachment are used, then tissue-based valves can be constructed, but the processes are labor intensive and time consuming
Solution Approach 1:
The patent replaces chemical fixation (glutaraldehyde) and mechanical suturing with a single-step molding process that creates the final valve structure. This substitution eliminates time-consuming chemical treatment and manual sewing operations, dramatically reducing manufacturing cycle time while simplifying the overall manufacturing process.
Solution Approach 2:
The patent performs all necessary structural formations (leaflet shaping, framework integration, fixation element creation) during the initial molding process. This preliminary action eliminates the need for subsequent fixation and attachment steps, reducing both manufacturing complexity and time requirements.
3Manufacturing precision
If manual fixation and attachment processes are used, then tissue-based valves can be assembled, but variability in valve performance results
Solution Approach 1:
The patent merges multiple assembly operations into a single molding process, creating an integrated valve structure where leaflets, framework, and fixation elements are formed together. This eliminates the complexity of multi-step assembly and ensures consistent construction quality through automated process control.
Solution Approach 2:
The patent replaces manual assembly operations with automated molding processes that precisely form the valve structure. This substitution eliminates human variability in fixation and attachment, ensuring consistent manufacturing precision across all produced valves.
Data Source
AI summary
A prosthetic heart valve includes a base and a plurality of polymeric leaflets. Each leaflet has a root portion coupled to the base, and each leaflet has an edge portion substantially opposite the root portion and movable relative to the root portion to coapt with a respective edge portion of at least one of the other leaflets of the plurality of leaflets. Each leaflet includes) at least two polymers along at least one portion of the leaflet, and each leaflet has a composition gradient of each of the at least two polymers along at least one portion of the leaflet.