Mitral Valve Prosthesis Self-Expanding Anchoring
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Solution Overview
Problem
Current heart valve prosthesis designs face challenges in achieving secure, aligned, and self-aligning placement without the need for balloons or stents, particularly in mitral valve positions with minimal invasiveness, and lack the ability to be easily deployed, folded, and redeployed for precise placement.
Innovation Solution
A mitral valve prosthesis system featuring a resilient ring with leaflet membranes and positioning elements, including tissue-piercing elements, that can invert and expand for secure anchoring within a catheter for minimally invasive delivery and self-orientation relative to the heart annulus, allowing for precise positioning and repositioning.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a stent system is used to anchor the valve prosthesis, then the valve can be secured in position, but the device cannot be repositioned, refolded, or easily removed and has large profile making percutaneous insertion difficult
Solution Approach 1:
The valve prosthesis employs a dynamic self-expanding mechanism where the frame automatically transitions from a compressed delivery state to an expanded deployed state through elastic memory properties of the shape memory alloy, eliminating the need for external stent systems while maintaining anchoring security and enabling repositionability
Solution Approach 2:
The patent utilizes phase transition and elastic deformation of shape memory alloy materials to change the mechanical properties of the valve frame, allowing it to be soft and compressible during insertion then rigid and self-expanding during deployment, resolving the contradiction between insertion ease and anchoring security
2Measurement precision
If balloon expandable stents are used for valve deployment, then the valve can be positioned, but the rigidity may allow regurgitation around the stent and the deployment process is complex requiring balloon inflation in moving blood
Solution Approach 1:
The valve prosthesis is designed to self-deploy through its inherent elastic memory properties, automatically expanding to the correct position and orientation without requiring external balloon inflation or complex deployment mechanisms, simplifying the procedure while maintaining placement precision
Solution Approach 2:
The patent replaces the complex mechanical balloon inflation system with a passive elastic self-expanding mechanism driven by shape memory alloy properties, eliminating the need for balloons and reducing procedural complexity while achieving accurate valve positioning
3Reliability
If the valve prosthesis is designed for secure anchoring, then it can remain in place, but it cannot be easily removed or repositioned
Solution Approach 1:
The self-expanding frame provides dynamic anchoring through elastic memory properties that allow the valve to be securely held in position while still permitting controlled compression and removal if needed, unlike rigid stent systems that permanently fix the valve in place
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
Enables secure, aligned, and self-aligning placement of the heart valve prosthesis with enhanced precision and safety, facilitating efficient percutaneous delivery and deployment, even in challenging anatomical conditions, while minimizing invasiveness and avoiding the limitations of balloon or stent-based systems.
Implementation Method 1
a frame of shape memory alloy having elastic memory properties and configured to be compressed to a delivery configuration and to automatically expand to a deployed configuration
Implementation Method 2
The self-expanding frame is well adapted for secure positioning in an annulus
Data Source
AI summary
Valve prostheses are disclosed that are adapted for secure and aligned placement relative to a heart annulus. The valve prostheses may be placed in a non-invasive manner, e.g., via transcatheter techniques. The valve prosthesis may include a resilient ring, a plurality of leaflet membranes mounted with respect to the resilient ring, and a plurality of positioning elements movably mounted with respect to the flexible ring. Each of the positioning elements defines respective proximal, intermediate, and distal tissue engaging regions cooperatively configured and dimensioned to simultaneously engage separate corresponding areas of the tissue of an anatomical structure, including respective first, second, and third elongate tissue-piercing elements. The proximal, distal, and intermediate tissue-engaging regions are cooperatively configured and dimensioned to simultaneously engage separate corresponding areas of the tissue of an anatomical structure so as to stabilize a position of the valve prosthesis with respect to the anatomical structure, including wherein for purposes of so simultaneously engaging the separate corresponding areas of tissue, at least one of the first, second, and third elongate tissue-piercing elements is pointed at least partially opposite the direction of blood flow, and at least another thereof is pointed at least partially along the direction of blood flow. The valve prosthesis may also include a skirt mounted with respect to the resilient ring for sealing a periphery of the valve prosthesis against a reverse flow of blood around the valve prosthesis.