Stepwise-Clamping Valve Prosthesis for Reversible Mitral Anchoring
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Solution Overview
Problem
Current transcatheter mitral valve prostheses face challenges in securely anchoring to the mitral valve due to irreversible anchoring tab release, limited clamping stability, and difficulty in balancing supporting force with clamping ability, leading to potential damage to surrounding tissues and regurgitation between valve leaflets.
Innovation Solution
A stepwise-clamping type valve prosthesis with a first and second clamping member, where the second clamping member extends from the first to surround adjacent chordae tendineae, allowing for reversible and secure anchoring, increasing the clamping area, and reducing regurgitation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If anchoring tabs are used for securing the valve prosthesis, then anchoring stability is improved, but the release is irreversible and it is difficult to ensure proper clamping of valve leaflets and chordae tendineae
Solution Approach 1:
The clamping member is divided into a first clamping member and a second clamping member that can be released independently in different stages. The first clamping member is released first to achieve initial anchoring, while the second clamping member remains clamped to maintain stability. This segmentation allows partial release while maintaining anchoring function, resolving the contradiction between reversibility and anchoring stability.
Solution Approach 2:
The clamping member transitions from a static, permanently clamped state to a dynamic, multi-stage releasable state. The controlled release mechanism allows the clamping force to be adjusted and released in stages, providing both initial anchoring stability and subsequent operational flexibility for proper positioning.
2Reliability
If anchoring tabs are used to clamp valve leaflets, then anchoring is achieved, but clamping stability is limited and surrounding tissues may be damaged
Solution Approach 1:
The clamping function is segmented into two stages: initial anchoring by the first clamping member and refined positioning by the second clamping member. This allows the prosthesis to be secured without requiring excessive clamping force that would damage surrounding tissues, as the second stage can be optimized for gentle, precise positioning.
Solution Approach 2:
The first clamping member performs preliminary anchoring to secure the prosthesis in place, creating a stable base. This preliminary action allows the second clamping member to then be released and positioned precisely without risking displacement, thereby avoiding the need for excessive force that would damage tissues.
3Device complexity
If a single clamping member is used, then device complexity is reduced, but clamping area is limited and regurgitation cannot be prevented
Solution Approach 1:
The clamping system is segmented into a first clamping member for anchoring and a second clamping member for enhanced sealing. This segmentation increases the effective clamping area and prevents regurgitation by addressing multiple functional requirements, while the modular design minimizes the added complexity.
Solution Approach 2:
The first and second clamping members are combined into an integrated system where both components work together to achieve comprehensive clamping. The first clamping member provides anchoring stability while the second clamping member extends the clamping area and prevents regurgitation, creating a synergistic effect that improves overall reliability without requiring completely separate systems.
4Strength
If the frame supporting force is increased, then structural stability is improved, but the aortic valve and surrounding tissues are pressed and normal function is affected
Solution Approach 1:
The clamping members perform preliminary anchoring and positioning before the frame is fully expanded to its maximum supporting force. This preliminary action secures the prosthesis in the correct position, allowing the frame to then be expanded with controlled force that provides structural stability without excessive compression of surrounding tissues.
Solution Approach 2:
The frame supporting force is applied dynamically in a controlled manner after the clamping members have established initial anchoring. This allows the system to transition from a low-force anchoring state to a higher-force structural support state, maintaining both structural stability and minimizing tissue compression through controlled force application.
Data Source
AI summary
The present application relates to a stepwise-clamping type valve prosthesis including a frame body and a clamping member. The frame body has a channel allowing blood to flow therethrough. The clamping member includes a first clamping member and a second clamping member. One end of the first clamping member is connected to the frame body, and the other end of the first clamping member is a free end. The second clamping member is connected to the first clamping member. The clamping member has three states in sequence from being restricted to being fully released. In the first state, the first clamping member and the second clamping member are both restricted and restricted. In the second state, the second clamping member is restricted, and the first clamping member extends in a radial direction of the frame body and is capable of reaching a position between a valve leaflet and a heart wall. In the third state, the second clamping member protrudes from the first clamping member and extends in a circumferential direction of the frame body and abuts against an outer surface of the frame body, so that an autologous valve leaflet and adjacent tissues are capable of being clamped between the second clamping member, the first clamping member, and the frame body. The contact area between the valve prosthesis and the autologous tissues can be increased, the position stability of the valve prosthesis in the heart can be improved, and the success rate of the operation can be increased.