Transcatheter Heart Valve Prosthesis With Wire-Driven Inflow Anchoring
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Solution Overview
Problem
Existing transcatheter heart valve replacement systems face challenges in preventing leakage and movement/migration of prosthetic valves due to varying anatomies and etiologies, particularly in aortic valve replacements, which can lead to paravalvular leakage and dislodgement.
Innovation Solution
A prosthetic heart valve system with an expandable frame, inflow member, and locking mechanism, featuring a wire that can be advanced within a channel to transition the inflow member into a deployed configuration, ensuring secure anchoring and minimizing leakage, while allowing for adjustment and repositioning post-implantation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If a prosthetic valve is delivered percutaneously in a compressed configuration, then minimally invasive delivery is achieved, but securing stable anchoring and preventing migration during deployment is difficult
Solution Approach 1:
The prosthetic valve is nested within a delivery catheter in a compressed state for percutaneous delivery, then deployed at the target site. The frame expands from a compressed configuration within the catheter to an expanded deployed configuration at the implantation site, enabling minimally invasive delivery while maintaining the ability to achieve stable anchoring upon deployment
Solution Approach 2:
The frame transitions from a static compressed state during delivery to a dynamic expanded state at the implantation site. This dynamic transformation allows the valve to adapt to varying anatomies and achieve stable anchoring after deployment, resolving the contradiction between ease of delivery and reliability of anchoring
2Reliability
If the prosthetic valve is expanded to engage tissue, then secure anchoring is achieved, but paravalvular leakage and valve migration still occur due to varying patient anatomies
Solution Approach 1:
The frame includes adjustable components such as commissure posts and an inflow member that can be independently positioned and adjusted. This allows local adaptation to varying anatomical conditions at different regions of the implantation site, achieving secure anchoring while accommodating patient-specific anatomies and preventing paravalvular leakage
Solution Approach 2:
The valve system includes adjustable components that can be modified after deployment. The inflow member can be repositioned by advancing a wire through a channel, and commissure posts can be adjusted to optimize alignment. This dynamic adjustability enables adaptation to varying anatomies while maintaining secure anchoring
3Reliability
If the valve is firmly anchored to prevent leakage, then paravalvular leakage is reduced, but valve repositioning or replacement becomes difficult
Solution Approach 1:
The valve system incorporates adjustable components including an inflow member that can be repositioned by advancing a wire through a channel, and commissure posts that can be adjusted. This dynamic design allows the valve to be firmly anchored to prevent leakage while still enabling repositioning or replacement if needed, resolving the contradiction between reliability and ease of repair
Solution Approach 2:
The valve includes self-adjusting features such as the wire-driven inflow member repositioning mechanism and adjustable commissure posts that can be modified through the delivery catheter. These self-service capabilities allow the valve to maintain secure anchoring while providing the ability to reposition or adjust alignment as needed
Data Source
Figure 1
Figure 2A~2B
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AI summary
Prosthetic heart valve devices, heart valve replacement systems and associated methods for percutaneous heart valve replacement are disclosed herein. A transcatheter heart valve prosthesis (100) configured in accordance herewith includes an expandable frame (110) having a plurality of commissure posts (130) extending therefrom, a radially expandable inflow member (140) attached to the plurality of commissure posts, and a locking mechanism (170) operably coupled to a wire (160). The wire is at least partially slideably disposed within a channel (146) formed in a wall of the inflow member and the locking mechanism is configured to permit the wire to be advanced within the channel to thereby transition the inflow member into a deployed configuration that at least partially engages tissue at the native heart valve.