Conical Transcatheter Heart Valve Structure for Reliable Sealing
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Solution Overview
Problem
Challenges exist in replicating the natural geometry of native heart valves, particularly the aortic valve, for percutaneous heart valve (PHV) implantation, which affects the sealing and closing efficiency, and the sinuses of Valsalva are often disrupted, leading to valve regurgitation and misalignment.
Innovation Solution
A transcatheter, percutaneously implantable bioprosthetic heart valve with conical cusps and leaflets, constructed from a flat sheet of mammalian tissue membrane, is designed to mimic the natural aortic valve geometry, featuring a lattice frame with integrated cusp and leaflet structures that are folded to form a conical shape, allowing for efficient compression and expansion, and a sealing cuff to ensure proper alignment and sealing.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If a percutaneous stent-mounted heart valve is used for minimally invasive implantation, then ease of operation and patient recovery are improved, but manufacturing precision and sealing reliability deteriorate due to difficulty in achieving exact alignment with the native valve seat
Solution Approach 1:
A separate sealing cuff made of flexible material is introduced as an intermediary component between the rigid stent frame and the native valve seat. This cuff can deform and conform to the irregular geometry of the diseased valve annulus, achieving reliable sealing without requiring precise alignment of the entire valve assembly. The sealing cuff acts as a mediator that absorbs misalignment errors and creates fluid-tight seals despite geometric mismatches.
2Reliability
If the native valve leaflets are pushed outward by the deployed PHV frame, then the diseased valve is replaced, but the native closing geometry is disrupted leading to valve regurgitation
Solution Approach 1:
The sealing function is extracted from the native valve leaflets and transferred to the artificial sealing cuff. The cuff is specifically designed to provide the sealing function that the diseased native leaflets can no longer perform, while the native leaflets are pushed aside or removed. This separation allows the PHV to effectively replace the diseased valve without relying on the disrupted native closing geometry.
3Reliability
If a cylindrical sealing cuff is added to provide sealing latitude, then sealing reliability is improved, but device complexity increases
Solution Approach 1:
The sealing cuff is merged with the stent frame to form an integrated assembly where the cuff is attached to or forms part of the frame structure. This integration reduces the number of separate components and simplifies the implantation procedure, as the sealing function and structural support are combined in a single assembled unit rather than requiring separate positioning and attachment steps.
Data Source
AI summary
A transcatheter, percutaneously implantable, prosthetic heart valve is provided that comprises a lattice frame and two or more integrated cusp and leaflet folded structures attached to the lattice frame. The two or more integrated cusp and leaflet folded structures each comprise a flat sheet of biocompatible membrane that is folded to include a substantially conical shape according to a flat folding pattern. The substantially conical shape is further formed by joining apposing sides of the substantially conical shape along a seam. The two or more integrated cusp and leaflet folded structures are each attached along their respective seams to the lattice frame in a direction substantially parallel to an axis of the lattice frame. Embodiments of valves described herein have application within the entire vascular system.