Heart Valve Leaflet Stitching Backer for Secure Attachment
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Solution Overview
Problem
Current medical devices for replacing heart valves are often invasive and require significant recovery time, and there is a need for less invasive methods for delivering and implanting replacement heart valves while ensuring effective functionality.
Innovation Solution
A medical implant system comprising a catheter-based delivery system with a radially expandable replacement heart valve assembly, featuring a tubular anchor member with axially movable post members and buckle members to secure leaflets, allowing percutaneous deployment and minimally invasive implantation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If traditional open-heart surgery is used for valve replacement, then reliable valve implantation is achieved, but patient trauma and recovery time increase significantly
Solution Approach 1:
The delivery system is segmented into multiple functional components including a catheter, expansion mechanism, and valve assembly. The valve itself is divided into leaflets mounted on a frame with separate attachment mechanisms, allowing for staged deployment and reducing the complexity of a single invasive procedure.
Solution Approach 2:
A catheter-based delivery system serves as an intermediary tool, enabling the valve to be delivered through a minimally invasive percutaneous approach rather than requiring direct surgical access to the heart. The expansion mechanism acts as an intermediary that transitions the valve from a compressed delivery state to an expanded functional state.
2Object-affected harmful factors
If minimally invasive percutaneous delivery is used, then patient trauma is reduced, but device complexity and manufacturing precision requirements increase
Solution Approach 1:
The valve assembly is nested within an expandable frame that is in turn nested within the delivery catheter. The leaflets are mounted on the frame in a compact configuration that allows passage through the catheter, then sequentially deployed as the frame expands. This nested structure enables minimally invasive delivery while maintaining valve functionality.
Solution Approach 2:
The delivery system incorporates dynamic expansion mechanisms that allow the frame to transition from a compressed low-profile state during delivery to an expanded functional state at the implantation site. This dynamic transformation reduces the need for complex manual manipulation and simplifies the deployment process.
3Reliability
If leaflets are securely attached to the frame, then valve function is ensured, but manufacturing precision and attachment reliability requirements increase
Solution Approach 1:
The leaflet attachment mechanism merges multiple functions into a single integrated structure. The frame serves both as the structural support and as the attachment substrate for the leaflets. Attachment elements are combined with the frame structure itself rather than being separate components, reducing the number of precision-critical interfaces.
Solution Approach 2:
The leaflets are pre-attached to the frame in a controlled manufacturing environment using preliminary attachment methods that allow for adjustment and verification. This preliminary assembly enables quality control measures to be applied before final deployment, ensuring proper attachment without requiring extreme precision during the implantation procedure itself.
Data Source
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AI summary
A replacement heart valve post and leaflet assembly may include at least a first post member including a body portion, a cantilevered leg portion, and a hinge portion configured to connect the body portion and the cantilevered leg portion and one or more leaflets. The cantilevered leg portion may comprise a longitudinally extending slot defined therein. At least a portion of a leaflet may extend through the slot. A backing element may be positioned over a portion of a leaflet such that the leaflet is secured between the cantilevered leg portion and the backing element.