Dual-Wireform Heart Valve Frame for Controlled Valve-in-Valve Expansion
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Solution Overview
Problem
Existing prosthetic heart valves are not configured to easily accommodate valve-in-valve procedures, as traditional prosthetic heart valves may not provide secure seating and sufficient annulus for new valve implantation, especially when a previously implanted valve requires replacement.
Innovation Solution
A prosthetic heart valve with a dual-wireform support frame that allows expansion by 2-3 mm, featuring an upper and lower wireform with specific undulating shapes and fabric coverings, enabling secure seating and limited expansion to accommodate an expandable prosthetic heart valve, while preventing further expansion beyond a certain diameter.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If a traditional prosthetic heart valve is used, then the valve structure is simple and manufacturing is easy, but the valve cannot accommodate valve-in-valve implantations and does not provide secure seating for replacement valves
Solution Approach 1:
The valve is divided into two separate wireforms: an upper wireform that remains stable and a lower wireform that can expand. This segmentation allows the lower wireform to be designed specifically for expansion capabilities while the upper wireform maintains structural integrity, enabling valve-in-valve implantation without compromising the entire valve structure.
Solution Approach 2:
The lower wireform is designed with dynamic expansion capability, allowing it to change from a compressed state during implantation to an expanded state for blood flow. This dynamic behavior enables the valve to adapt to different sizes and accommodate replacement valves while maintaining proper function.
2Adaptability or versatility
If the valve annulus is expanded to receive a new valve, then valve replacement is enabled, but excessive expansion may compromise structural integrity and blood flow support
Solution Approach 1:
The dual wireform structure segments the expansion function into the lower wireform only, while the upper wireform maintains structural integrity. This allows controlled expansion up to 3mm without compromising the overall valve structure or blood flow support.
Solution Approach 2:
The lower wireform is designed with specific geometric parameters (shallow undulations, truncated peaks) that limit expansion to 3mm. This parameter control ensures that expansion provides sufficient space for replacement valves while maintaining structural integrity and proper blood flow.
3Adaptability or versatility
If the lower wireform is made highly expandable, then valve size adjustment is possible, but the valve may expand beyond the required 3mm limit and compromise function
Solution Approach 1:
The lower wireform incorporates specific geometric parameters (shallow undulations, truncated peaks at 10-30% height of commissure posts) that precisely control expansion to 3mm. These parameter designs ensure consistent expansion behavior while maintaining manufacturing precision.
Solution Approach 2:
The lower wireform acts as an intermediary element between the expansion force and the upper wireform. It mediates the expansion process by absorbing the expansion force and limiting it to 3mm, preventing excessive expansion while still providing sufficient size adjustment for different valve requirements.
Data Source
AI summary
A prosthetic heart valve configured to replace a native heart valve and having a support frame configured to be reshaped into an expanded form in order to receive and/or support an expandable prosthetic heart valve therein. A dual-wireform support frame including an upper and a lower wireform permits expansion of the valve by one or two valve sizes, for example, with a 2-mm gap between each valve size. The lower wireform has a relatively shallow undulation so that it may stretch apart by a small amount and then prevent further expansion of the valve.