ePTFE Synthetic Heart Valve with Flexible Stent
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Solution Overview
Problem
Current heart valves, whether from human cadavers (homografts) or animals (xenografts), face limitations in availability and durability, with xenografts like porcine valves degenerating over time and being unsuitable for a wide range of human sizes, while synthetic valves lack versatility and longevity.
Innovation Solution
A synthetic heart valve made from expanded polytetrafluoroethylene (ePTFE) with a flexible stent, featuring three semicircular valve leaflets sutured to a cylindrical sleeve, which can be delivered via a balloon catheter, offering a versatile and durable alternative with automated manufacturing capabilities.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Quantity of substance
If xenograft valves are used to replace heart valves, then availability increases, but durability decreases due to degradation over time
Solution Approach 1:
The patent changes the material parameter from biological tissue (xenograft) to synthetic material (ePTFE), fundamentally altering the durability characteristic while maintaining availability. The synthetic material does not degrade over time like biological tissues, thus resolving the contradiction between availability and durability.
Solution Approach 2:
The patent uses a composite structure combining ePTFE synthetic material with a stent framework. This composite construction provides both the availability of mass-produced implants and the durability of non-biodegradable materials, overcoming the limitations of pure xenograft valves.
2Quantity of substance
If xenograft valves are used, then availability increases, but adaptability decreases due to limited size range
Solution Approach 1:
The patent designs the ePTFE heart valve with adjustable and customizable dimensions, allowing a single synthetic valve design to serve multiple patient size requirements. The stent framework can be configured in various sizes, making the valve universally applicable across different patient populations, thus resolving the contradiction between availability and adaptability.
3Adaptability or versatility
If synthetic valves are used, then adaptability increases with unlimited sizes, but manufacturing complexity increases
Solution Approach 1:
The patent divides the heart valve into modular components: the ePTFE synthetic valve body and the stent framework. This segmentation allows independent manufacturing and assembly of standardized components, reducing overall manufacturing complexity while maintaining adaptability through modular configuration.
Solution Approach 2:
The ePTFE valve is pre-formed into a cylindrical shape with predetermined dimensions before implantation. This preliminary formation simplifies the final assembly process and reduces surgical complexity, as the valve requires minimal manipulation during implantation despite its customizable size options.
Data Source
AI summary
A synthetic heart valve is made from a valve graft of synthetic material and more particularly expanded polytetrafluoroethylene (ePTFE). The valve graft has an upper portion defined by a first thickness and a lower portion defined by a second thickness which is greater than the first thickness. The valve graft is formed into a cylindrical sleeve having a diameter and a folded region. A flexible stent overlays the cylindrical sleeve, wherein a series of leaflets are formed in the lower portion of the sleeve, the leaflets defining a semicircular perimeter. The leaflets are sutured to the cylindrical sleeve and the cylindrical sleeve is sutured to the flexible stent, the stent having a plurality of bent cylindrical wire segments that are welded together and in which the sleeve is sutured to the wire, including the welded areas of the stent. The formed valve can be implanted using a balloon catheter.