Prosthetic Heart Valve Dynamic Frame for Percutaneous Delivery
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Solution Overview
Problem
Ischemic heart disease causes regurgitation of heart valves due to papillary muscle dysfunction and ventricular dilation, leading to incomplete coaptation of valve leaflets, resulting in blood regurgitation and decreased cardiac output.
Innovation Solution
A prosthetic heart valve implant with a tubular portion, upstream support portion, and flanges is percutaneously deliverable to a native heart valve in a compressed state, expandable to secure tissue between the support portion and flanges, using an inner and outer frame assembly with flexible sheets to facilitate one-way blood flow.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Length of moving object
If the valve is delivered in a compressed state, then the delivery profile is reduced enabling percutaneous access, but the valve cannot be immediately functional at the native valve
Solution Approach 1:
The valve frame is designed to dynamically transition from a compressed delivery configuration to an expanded functional configuration at the native valve. The frame members can move between a collapsed state for delivery and a deployed state for operation, enabling the valve to adapt its geometry based on the operational requirement.
Solution Approach 2:
The valve utilizes changes in physical parameters during delivery and deployment. The frame members undergo dimensional changes from a compressed state during delivery to an expanded state at the native valve. This parameter transformation enables the valve to achieve both percutaneous deliverability and functional integrity at the target location.
2Adaptability or versatility
If the frame members are made resilient, then the valve can be compressed for delivery and expanded at the native valve, but the complexity of the device increases
Solution Approach 1:
The valve frame is segmented into multiple independent frame members that can move relative to each other. This segmentation allows the frame to be compressed by collapsing the members and expanded by deploying them, providing adaptability without requiring a completely different structural system.
Solution Approach 2:
The frame members are designed to nest within each other during compression, with inner members fitting inside outer members. This nesting arrangement enables compact delivery profile while maintaining the ability to expand to full size at the native valve, achieving versatility within a manageable structural complexity.
3Reliability
If the valve leaflets are secured between the upstream support portion and flanges, then proper coaptation is achieved preventing regurgitation, but the surgical procedure becomes more complex
Solution Approach 1:
The valve assembly process is designed to be self-aligning, where the frame members and support portions automatically position themselves during implantation. The resilient frame members naturally conform to the native valve anatomy, reducing the need for complex manual alignment procedures while ensuring reliable coaptation.
Solution Approach 2:
The valve is pre-assembled with the leaflets secured between the upstream support portion and flanges in a controlled manufacturing environment. This preliminary assembly ensures proper coaptation geometry is achieved during fabrication, and the valve is then delivered as a complete functional unit, simplifying the surgical procedure.
Data Source
AI summary
A method for assembling a prosthetic valve includes obtaining (1) a frame assembly that includes a tubular portion and ventricular legs that extend radially outward from the tubular portion, and (2) a piece of flat, flexible material shaped to define (i) a belt, and (ii) strips extending from the belt along a respective strip-axis. Each strip is folded into a pocket by folding the strip over itself, about a fold-line that is orthogonal to the strip-axis, thereby forming (i) a first strip-portion that extends from the belt to the fold-line, and (ii) a second strip-portion that extends from the fold-line back toward the belt, and stitching together the first and second strip-portions at the first edge, and the first and second strip-portions at the second edge. Each leg is slid into a pocket. The belt is wrapped around the tubular portion. Other embodiments are also described.