Leaflet-Clipping Heart Valve Prosthesis for Precise Anchoring
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Solution Overview
Problem
Conventional heart valve replacement surgeries are invasive and require lengthy recovery periods, and transcatheter prosthetic valves face challenges such as vessel damage, imprecise positioning, and complications like paravalvular leakage and coronary artery blockage during delivery.
Innovation Solution
A heart valve prosthesis delivery system with a reduced passing profile, utilizing a two-part distal carrier assembly and tethering component to facilitate precise, less invasive implantation through a transcatheter approach, allowing components to be advanced in tandem with variable displacement and controlled motion, and anchored securely to the native valve.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a conventional heart valve replacement surgery is performed through open-heart surgery, then the valve can be replaced effectively, but the surgery is highly invasive and requires lengthy recovery
Solution Approach 1:
The delivery device is divided into multiple components including a catheter, a delivery sheath, and a valve prosthesis with separate anchoring mechanism. This segmentation allows the valve to be delivered through a minimally invasive transvascular approach while maintaining effective replacement capability
Solution Approach 2:
The valve prosthesis is nested within the delivery sheath in a compressed state during delivery, and then expanded to its functional configuration at the implantation site. This nesting enables the valve to pass through small vascular access points while maintaining its full functional size at the target location
2Object-affected harmful factors
If a transcatheter prosthetic valve is delivered through blood vessels, then invasiveness is reduced, but vessel damage and imprecise positioning occur
Solution Approach 1:
The anchoring component is designed to engage with the native valve structure before final valve deployment. This preliminary anchoring action secures the valve at the precise implantation site and prevents migration, while the controlled delivery system protects the blood vessels from damage during insertion
Solution Approach 2:
The delivery device acts as an intermediary between the operator and the valve prosthesis, providing controlled manipulation and positioning. The device includes features such as a release mechanism and positioning markers that enable precise placement while minimizing direct manipulation of the valve and surrounding vessels
3Ease of operation
If the valve prosthesis components are advanced in tandem with variable displacement, then maneuverability is improved, but device complexity increases
Solution Approach 1:
The delivery device incorporates dynamic elements that allow variable displacement between the valve frame and anchoring component during delivery. This dynamic configuration enables the operator to adjust the relative positioning of components to navigate tortuous vasculature and achieve optimal implantation geometry
Solution Approach 2:
The delivery device is designed with multi-functional components that can perform multiple operations. The same device structure enables both the advancement of the valve prosthesis and the deployment of the anchoring mechanism, reducing the need for separate specialized devices while maintaining maneuverability
Data Source
AI summary
A heart valve prosthesis can have a leaflet clipping mechanism that is used to engage the prosthesis within a prosthetic or native heart valve structure. The prosthesis can include a valve anchor with U-shaped members that each have base portions and engagement structures extending from each base portion. The prosthesis can also include an expandable valve frame and a link mechanism interconnecting the valve anchor with the valve frame. The U-shaped members and the valve frame can collectively form a clipping mechanism that is configured to engage valve leaflets of the prosthetic or native heart valve therebetween.