Inverting Valve Prosthesis Positioning Elements for Secure Anchoring
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Solution Overview
Problem
Current heart valve prosthesis designs face challenges in achieving secure and aligned placement relative to the heart annulus, particularly in the absence of balloon or stent systems, and struggle with repositioning and deployment precision, especially in non-calcified annulus conditions.
Innovation Solution
A mitral valve prosthesis system featuring a resilient ring with leaflet membranes and positioning elements that can invert and rotate to engage tissue, allowing for secure alignment and repositioning, and a collapsible design for percutaneous delivery via a catheter, enabling precise placement and anchoring without extensive surgery.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a stent system is used to anchor the valve prosthesis, then the valve can be securely anchored in the aortic channel, but the design is not amenable to placement at the location of the biologic valve and cannot be repositioned
Solution Approach 1:
The valve prosthesis employs a dynamic delivery system where the stent is initially compressed within a delivery catheter, then expanded at the target site using a balloon. This dynamic transformation from compressed to expanded state enables the valve to be delivered percutaneously and positioned at the biologic valve location, resolving the contradiction between secure anchoring and placement flexibility
Solution Approach 2:
The valve prosthesis is nested within a delivery catheter in a compressed state, allowing it to pass through the vascular system to the heart. Once positioned, the valve is deployed from the catheter and expanded at the target site. This nesting approach enables percutaneous delivery and repositioning capability while maintaining secure anchoring function
2Reliability
If a balloon-expandable stent is used, then the valve can be deployed in calcified positions, but regurgitation may occur around the outside of the stent and the design cannot be repositioned
Solution Approach 1:
The valve prosthesis design incorporates a stent with specific local structural characteristics that provide radial strength for anchoring in calcified positions while including features such as radiopaque markers and a compliant structure that reduces the risk of regurgitation. The stent is designed with varying wall thickness and expansion characteristics at different locations to optimize both anchoring and sealing
3Ease of operation
If a self-expanding stent design is used, then the valve can be deployed without balloon inflation, but it is difficult to position accurately during deployment
Solution Approach 1:
The valve prosthesis incorporates radiopaque markers on the stent structure that provide visual feedback during deployment, allowing the operator to monitor the expansion process and position of the valve in real-time. This feedback mechanism enables accurate positioning while maintaining the simplicity of self-expanding deployment without requiring complex balloon inflation procedures
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 system facilitates secure, aligned, and repositionable heart valve placement, enhancing precision and safety by allowing for percutaneous delivery and self-alignment, improving valve function without the need for invasive surgery and reducing complications associated with existing stent-based designs.
Implementation Method 1
a resilient ring 106, a plurality of leaflet membranes 108 mounted with respect to the flexible ring 106, and a plurality of positioning elements 120 movably mounted with respect to the flexible ring 106
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 trans-catheter techniques, and may be positioned/repositioned until proper alignment and positioning is achieved. 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 defining a first tissue engaging region and a second tissue engaging region spaced from the first tissue engaging region. The positioning elements are adapted to substantially completely invert by rotating relative to the resilient ring between a first position in which each of the first and second tissue engaging regions is inwardly directed for facilitating positioning of the valve prosthesis within a delivery catheter, and a second position in which each of the first and second tissue engaging regions is outwardly directed for engaging tissue. The valve prosthesis may also include a valve skirt mounted with respect to the resilient ring.