Single-Leaflet Xenogeneic Bioprosthesis for Deep Venous Insufficiency
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Solution Overview
Problem
Current therapies for venous valve replacement, such as allograft or cryopreserved valves, face challenges in harvesting and immune response issues, limiting effective treatment options for patients with chronic deep vein insufficiency.
Innovation Solution
A bioprosthetic valve using a single xenogeneic aortic valve leaflet attached to a patch of contiguous tissue, which is fixed and processed to enhance durability and reduce antigenicity, is implanted into a host vein, mimicking natural venous valve hemodynamics and geometry.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If allograft valves are used for venous valve replacement, then valve replacement is achieved, but harvesting difficulty increases and treatment options are limited
Solution Approach 1:
The patent extracts only the necessary functional component (a single aortic valve leaflet) from the complex donor heart valve, removing unnecessary structures while preserving the essential valve function. This extraction approach simplifies the harvesting process and reduces the complexity of processing large amounts of donor tissue.
Solution Approach 2:
The patent segments the aortic valve leaflet from the rest of the heart valve structure, creating a discrete, isolated component that can be processed independently. This segmentation allows for simplified harvesting and processing while maintaining the functional integrity of the valve leaflet for venous replacement.
2Reliability
If cryopreserved valves are used for venous valve replacement, then valve replacement is achieved, but immune response increases
Solution Approach 1:
The patent extracts and processes only the essential functional elements of the donor valve leaflet, removing and destroying cellular components that would trigger immune responses. This extraction of functional capability while eliminating immunogenic material reduces immune rejection while preserving valve function.
Solution Approach 2:
The patent applies extensive processing that fundamentally changes the physical and chemical parameters of the donor tissue, transforming it from an immunogenic state to a non-immunogenic state while preserving the structural integrity and functional capability of the valve leaflet for venous replacement.
3Reliability
If conventional venous valve replacement is used, then valve replacement is achieved, but hemodynamic function is insufficient
Solution Approach 1:
The patent applies local quality by using a single, carefully selected aortic valve leaflet that is specifically suited for venous replacement, rather than using conventional venous valve tissue. The leaflet's specific structural properties are optimized for the low-flow, low-pressure conditions of the venous system, providing superior hemodynamic function.
Solution Approach 2:
The patent creates a composite structure by attaching the aortic valve leaflet to a patch of contiguous tissue from the same donor heart valve. This composite construction provides both the functional leaflet tissue and the structural support needed for durable venous valve replacement with improved hemodynamics.
Data Source
AI summary
A bioprosthetic valve for repairing a deep venous insufficiency in a subject includes a single leaflet from a xenogeneic heart valve attached at natural margins of attachment to a patch of valve wall tissue. The patch may extend axially above and below the leaflet and circumferentially on either side of the leaflet to provide a region for attaching the patch to a fenestration in a host vein. A bioprosthetic valve may be manufactured by excising a portion of a xenogeneic heart valve including a single leaflet and contiguous wall tissue, and may further comprise shaving off excess leaflet tissue from adjacent leaflets. A method of replacing a malfunctioning venous valve in a subject includes providing a bioprosthetic valve as described above and inserting it to the host vein.