Self-Expanding Valve Prosthesis Frame with Flexible Region
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Solution Overview
Problem
Current methods for delivering artificial heart valves are invasive and require significant bending force due to the stiffness of traditional delivery systems, which can cause kinking and trauma to the patient's vasculature, especially when navigating vascular bends like the aortic arch.
Innovation Solution
A self-expanding valve prosthesis frame with a localized concave depression, allowing for flexibility during delivery, which reduces the outer diameter and facilitates bending, flexing, and kinking, enabling smoother navigation through vascular bends without causing trauma.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Strength
If a stiff delivery system is used to support the valve prosthesis frame, then the structural integrity and rigidity are improved, but the ability to navigate vascular bends without kinking or folding deteriorates
Solution Approach 1:
The delivery system is divided into multiple segments with varying degrees of flexibility. The proximal portion is more flexible to navigate bends, while the distal portion maintains rigidity to support the valve prosthesis frame, resolving the contradiction between overall structural integrity and local navigability.
Solution Approach 2:
Different portions of the delivery system are assigned different mechanical properties. The proximal section is designed with higher flexibility to accommodate vascular bends, while the distal section maintains stiffness to provide structural support for the valve prosthesis, allowing each region to optimize its function locally.
2Reliability
If a long valve prosthesis frame is used to anchor in the aortic annulus and ascending aorta, then the anchoring stability is improved, but the ability to bend and traverse vascular bends deteriorates
Solution Approach 1:
The delivery system incorporates dynamic flexibility characteristics that allow it to bend and conform to vascular anatomy during delivery, then transition to a stable, rigid configuration once deployed to provide reliable anchoring in the aortic annulus and ascending aorta.
Solution Approach 2:
The valve prosthesis frame is segmented into different sections with varying rigidity. The proximal portion is more flexible to navigate bends, while the distal portion provides rigid anchoring support, allowing the overall structure to achieve both flexibility during delivery and stability after deployment.
3Ease of operation
If a large amount of bending force is applied to flex the delivery system, then the ability to traverse bends is improved, but the risk of kinking and trauma to the vasculature increases
Solution Approach 1:
The delivery system's mechanical parameters are optimized to provide appropriate flexibility and bend radius. By controlling the flexibility parameter, the system can navigate vascular bends with sufficient curvature without requiring excessive bending force, thereby avoiding kinking and vascular trauma while maintaining traversability.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
The flexible design of the valve prosthesis frame reduces the risk of kinking and trauma during delivery, allowing for successful deployment and anchoring in the heart while minimizing perivalvular leaks and migration, thus improving the safety and efficacy of minimally invasive procedures.
Implementation Method 1
The valve prosthesis is provided with a self-expanding frame which assumes a predetermined configuration
Implementation Method 2
The flexible region is created by deforming a portion of the nitinol material and/or heat treating the nitinol material
Data Source
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AI summary
A heart valve prosthesis and delivery systems are provided for replacing a cardiac valve. The heart valve prosthesis includes a self-expanding frame includes a portion having a crimp that provides additional flexibility to the self-expanding frame in the collapsed configuration.