Mitral Valve Replacement Support With Isolated Retainer Anchoring
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Solution Overview
Problem
Current prosthetic heart valve devices face challenges in effectively replacing the mitral valve due to its non-circular, asymmetric shape and lack of radial support, leading to issues like leaks, distortion, and complications from distorting forces, especially when using percutaneous methods.
Innovation Solution
The development of prosthetic heart valve devices with a flexible valve support that conforms to the mitral valve's irregular shape and includes a mechanically isolated retainer to absorb distorting forces, ensuring proper leaflet coaptation and anchoring without distorting the support structure.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Shape
If a rigid, circular valve support is used for percutaneous mitral valve replacement, then the device can be easily manufactured and deployed, but it cannot conform to the mitral valve's non-circular, asymmetric shape, leading to leaks and improper leaflet coaptation
Solution Approach 1:
The valve support is designed as a flexible structure that can deform to conform to the non-circular, asymmetric shape of the mitral valve annulus. This flexibility allows the device to adapt to the patient's specific anatomy while maintaining structural integrity through the flexible material properties and design
Solution Approach 2:
The valve support transitions from a symmetric circular design to an asymmetric configuration that matches the natural D-shaped or non-circular geometry of the mitral valve. This asymmetric design enables proper alignment with the valve annulus and ensures appropriate leaflet coaptation without gaps or overlaps
2Reliability
If the valve support directly engages with the mitral valve tissue to anchor the device, then anchoring is achieved, but distorting forces from the irregular tissue shape cause distortion of the support structure and improper leaflet function
Solution Approach 1:
The valve support structure is divided into distinct functional segments: an anchoring portion that engages with the mitral valve tissue and a supported portion that maintains the prosthetic valve. This segmentation allows the anchoring segment to absorb distorting forces while the supported segment remains stable and undistorted, ensuring proper leaflet function
Solution Approach 2:
The valve support acts as an intermediary structure between the irregular mitral valve tissue and the prosthetic valve. It absorbs and isolates distorting forces from the tissue, preventing these forces from being transmitted to the prosthetic valve and ensuring stable, distortion-free operation
3Reliability
If traditional open surgical approaches are used for mitral valve replacement, then complete valve replacement can be achieved, but the procedure is highly invasive with significant morbidity and long recovery periods
Solution Approach 1:
The procedure extracts the need for open surgical access by delivering the prosthetic valve through a percutaneous catheter approach. The valve is delivered through a small vascular access point rather than requiring a large thoracotomy, significantly reducing surgical trauma while maintaining effective valve replacement
Solution Approach 2:
The traditional mechanical surgical approach (open chest, direct visualization, manual suturing) is replaced with a catheter-based delivery system that uses controlled expansion and self-centering mechanisms to deploy the valve in situ, reducing the mechanical trauma associated with open surgery
Data Source
AI summary
A heart valve repair device may include a support configured to extend through a native annulus of a native heart valve, wherein the support comprises an upstream portion and a downstream portion; an annular expandable retainer extending from the upstream portion of the support, and an arm extending from the downstream portion of the support. The annular expandable retainer may include a C-shaped cross-section that is open inwardly. The arm may be configured to reach behind a leaflet of the native heart valve and sandwich the leaflet between the arm and the support.