Multi-Level Heart Valve Frame for Minimally Invasive Leaflet Anchoring
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Solution Overview
Problem
Existing surgical treatments for cardiac valve malfunctions, such as mitral and tricuspid valve issues, require open-heart procedures and extracorporeal circulation, and existing devices for artificial cardiac valve support do not address the need for a minimally invasive solution.
Innovation Solution
A heart valve prosthesis frame designed with a plurality of struts and connectors, including a frame with connectors arranged as wire arcs, and connectors attached to struts, forming a frame with at least three rows to support and anchor natural heart valve leaflets, allowing for minimally invasive implantation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If open-heart procedures are used for cardiac valve repair or replacement, then reliable valve treatment is achieved, but surgical complexity and patient risk increase
Solution Approach 1:
The cardiac valve prosthesis is divided into multiple segments including an upstream portion, a downstream portion, and multiple rows of connectors. This segmentation allows the device to be delivered through a catheter in a compressed state and then expanded in situ, avoiding open-heart surgery while maintaining treatment effectiveness
Solution Approach 2:
The frame structure is designed to be nested within a delivery catheter during implantation. The upstream and downstream portions along with connectors are compressed together inside the catheter, allowing minimally invasive delivery followed by expansion to the functional configuration
2Reliability
If traditional artificial cardiac valve support devices are used, then valve support is provided, but minimally invasive implantation is not achieved
Solution Approach 1:
The frame is designed with dynamic characteristics, transitioning from a compressed delivery configuration to an expanded functional configuration. The upstream and downstream portions can expand radially after delivery, and the connectors can engage with valve tissue dynamically during the implantation process
Solution Approach 2:
The device utilizes parameter changes in its deployment mechanism. The frame transitions from a low-profile compressed state suitable for catheter delivery to a high-profile expanded state that provides effective valve support. The connectors also undergo parameter changes from a retracted position to an engaged position with the valve tissue
3Reliability
If multiple rows of connectors are used to anchor leaflets at multiple levels, then anchoring reliability is improved, but device complexity increases
Solution Approach 1:
The connectors serve multiple functions: they structurally link the upstream and downstream portions of the frame, provide anchoring points for valve leaflets at multiple levels, and maintain the radial expansion of the frame. This multi-functionality reduces the need for separate anchoring mechanisms
Data Source
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Figure 2A~2B
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AI summary
A heart valve prosthesis including a frame, the frame including a plurality of struts designed to extend from an upstream side of a natural heart valve to a downstream side of the natural heart valve, and a plurality of connectors attached to the plurality of struts, wherein the plurality of connectors are arranged as arcs connecting the struts, the arcs having two ends, each end attached to one of the struts, and a peak pointing from a center of the frame circumferentially outward and toward the upstream side of the frame, and the plurality of connectors are arranged as at least two rows, each row circumnavigating the center lumen of the frame. Related apparatus and methods are also described.