Planar Prosthetic Valve with Biointegrating Sewing Ring
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Solution Overview
Problem
Current prosthetic heart valves, whether mechanical or tissue-based, face challenges such as peri-valvular leakage, calcification, and the need for repeated surgeries due to growth in pediatric patients, as well as the inability of conventional sewing rings to accurately fit uneven annulus contours, leading to potential leakage and reduced valve longevity.
Innovation Solution
A prosthetic tissue valve designed to be substantially planar before implantation, with a biointegrating sewing ring made from extracellular matrix materials that can expand and integrate with the body, allowing for a larger circumference and diameter than the annulus, and a sinusoidal attachment pattern to mimic native valve function, reducing the need for reoperation and minimizing leakage.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a conventional sewing ring is used to attach the prosthetic valve to the annulus, then the valve can be implanted, but the sewing ring remains in a single plane and cannot accommodate uneven annulus contours, leading to perivalvular leakage
Solution Approach 1:
The sewing ring is designed to transition from a planar configuration during implantation to a non-planar configuration after implantation, allowing it to adapt to the uneven contours of the annulus. This dynamic transformation enables the sewing ring to maintain contact with the irregular annular surface, preventing perivalvular leakage while accommodating anatomical variations.
Solution Approach 2:
The sewing ring undergoes a change in its geometric parameters, specifically transitioning from a flat, two-dimensional structure to a three-dimensional, non-planar structure that conforms to the annulus. This parameter change allows the sewing ring to match the complex topology of the annular attachment site, ensuring a reliable seal.
2Adaptability or versatility
If the valve is made with a larger circumference and diameter than the annulus, then it can accommodate growth in pediatric patients, but the valve requires a more complex expansion mechanism
Solution Approach 1:
The valve is designed with dynamic expansion capabilities, allowing it to grow from an initially smaller size to a larger size as the pediatric patient grows. The valve structure incorporates mechanisms that enable controlled expansion of the circumference and diameter, accommodating patient growth without requiring replacement surgery.
Solution Approach 2:
The valve employs a nested configuration where components are arranged to allow for expansion. The valve can be implanted in a compressed state and then expand to its full size, providing a space-efficient solution that accommodates growth while maintaining a compact implantation profile.
3Ease of manufacture
If the valve is made planar prior to implantation, then it can be easily manufactured and stored, but it must undergo transformation after implantation to achieve its functional non-planar shape
Solution Approach 1:
The valve is manufactured in a planar state, which simplifies fabrication and storage. Before implantation, the valve is prepared in this easy-to-manage flat configuration. During the implantation process, the valve is then transformed into its functional non-planar shape, allowing the benefits of simple manufacturing to be combined with the performance requirements of the implanted device.
Solution Approach 2:
The valve incorporates dynamic transformation capabilities that allow it to change from a static planar configuration to a dynamic non-planar configuration. This transformation occurs after implantation, enabling the valve to achieve its functional shape while maintaining manufacturing simplicity.
4Ease of operation
If tissue valves are used instead of mechanical valves, then anticoagulant administration is not required, but the tissue wears out faster and requires replacement every 10-15 years
Solution Approach 1:
The valve utilizes materials and structural parameters that enhance the durability of tissue valves. By modifying the tissue properties and valve architecture, the lifespan of the tissue valve is extended beyond the typical 10-15 years, reducing the frequency of replacements while maintaining the advantage of not requiring anticoagulant therapy.
Data Source
AI summary
A prosthetic tissue valve for aortic, pulmonary, mitral or tricuspid valve replacement is described herein. A sewing ring for use with the prosthetic tissue valve is also described. The valve can have a circumference that is a predetermined distance larger than the circumference of an annulus in a defective valve. The valve can be substantially planar in an unstressed position before attachment at the annulus and substantially non-planar upon attachment in a biased position at the annulus. Methods are provided for placing the valve as described herein in the biased position within the annulus of the defective valve.