Multi-Part Prosthetic Valve Frames With Bridging Covers for Emboli Reduction
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Solution Overview
Problem
Challenges exist with accessing, positioning, and ensuring efficacy of transcatheter prosthetic valves within the anatomy, particularly in minimizing trauma and complications such as emboli during delivery and deployment.
Innovation Solution
A multi-part frame prosthetic valve design with a leaflet frame subcomponent and an anchor frame subcomponent separated by a gap, utilizing a connecting sheath and annular groove covers or bridging members to facilitate smooth flow, reduce emboli, and assist with telescoping and positioning, with optional blood permeability features.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Object-affected harmful factors
If a multi-part frame design with gap between subcomponents is used, then smoother flow profile and reduced emboli are achieved, but device complexity increases
Solution Approach 1:
The frame is divided into multiple subcomponents (first and second subcomponents) with a gap between them, allowing independent optimization of each segment for flow characteristics while maintaining overall structural integrity
Solution Approach 2:
A bridging member is introduced as an intermediary element to span the gap between frame subcomponents, providing a controlled pathway that reduces emboli formation while maintaining the benefits of the segmented design
2Length of moving object
If telescoping nesting of subcomponents is implemented, then delivery profile is reduced, but manufacturing precision requirements increase
Solution Approach 1:
The frame subcomponents are designed to telescope and nest within each other during delivery, significantly reducing the overall profile for catheter-based delivery while maintaining the ability to deploy the full expanded structure at the target site
Solution Approach 2:
The bridging member is pre-configured in a compressed state that allows it to be nested with the frame subcomponents during delivery, and it automatically transitions to its functional configuration upon deployment
3Shape
If bridging members are added to cover gap, then flow profile is improved, but device complexity increases
Solution Approach 1:
The bridging member is specifically positioned to cover the gap region where flow disturbances occur, providing localized flow management without requiring modification of the entire frame structure
Solution Approach 2:
The bridging member serves multiple functions simultaneously: it bridges the gap between subcomponents, improves flow profile, reduces emboli formation, and provides a structure for potential tissue ingrowth or sealing
Data Source
AI summary
Concepts disclosed relate to multi-frame prosthetic valves including leaflet and anchor frame subcomponents, where the leaflet frame subcomponent does not directly couple with patient anatomy and is separated from the anchor frame subcomponent by a gap/space. An optional connecting sheath may be provided to interconnect the subcomponents and assist with prosthetic valve delivery and deployment. One or more bridging members, or annular groove covers, are provided to bridge and cover gap or space between the anchor frame subcomponent and leaflet frame subcomponent, such as at the inflow and/or outflow ends of the subcomponents. Such bridging/cover features may provide smoother flow profiles, reduce incidence of complications, facilitate perfusion during delivery, assist with device nesting during delivery, assist with relative subcomponent positioning following delivery, or provide any of a variety of additional or alternative functions and advantages.