Self-Expanding Heart Valve Prosthesis with Four Commissure Points
Find Innovative SolutionsGenerate Solutions
Solution Overview
Problem
Traditional methods for cardiac valve replacement, such as open heart surgery and minimally invasive procedures, are traumatic and pose risks to patients, while percutaneous approaches face challenges in maintaining valve stability and preventing leaks and migration.
Innovation Solution
A self-expanding frame valve prosthesis with a valve body comprising three leaflets and four commissure points sewn to the frame, designed for percutaneous delivery, which mimics native valve anatomy to ensure proper alignment, prevent leaks, and maintain stability by anchoring in the native valve annulus.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Object-affected harmful factors
If percutaneous transluminal delivery is used to avoid open heart surgery, then patient trauma and recovery time are reduced, but valve stability and protection of critical components are compromised
Solution Approach 1:
The valve prosthesis is nested within a delivery catheter in a compressed state, allowing percutaneous delivery through the femoral artery. The self-expanding frame is contained within the catheter until deployment, enabling minimally invasive delivery while maintaining the structural integrity needed for reliability.
Solution Approach 2:
The frame transitions from a compressed dynamic state during delivery to an expanded stable state at the implantation site. The self-expanding capability allows the frame to adapt to the native valve annulus geometry while maintaining consistent radial force for stability.
2Ease of operation
If a compacted valve prosthesis is delivered through a catheter, then minimally invasive delivery is achieved, but uniform rigidity and protection of critical valve components during delivery and deployment is difficult to maintain
Solution Approach 1:
The valve prosthesis is segmented into distinct components (frame, leaflets, commissure points) that can be independently protected during delivery. The frame acts as a protective structure for the leaflets during the delivery process, while allowing controlled deployment at the target site.
Solution Approach 2:
The self-expanding frame provides inherent cushioning and protection for the leaflets during delivery and deployment. The frame's elastic properties absorb mechanical stresses before they reach the critical leaflet components, preventing damage during the delivery process.
3Adaptability or versatility
If the valve prosthesis is designed to conform to patient anatomy, then proper alignment and function are achieved, but maintaining uniform rigidity across different anatomical configurations becomes challenging
Solution Approach 1:
The frame is designed with varying local properties - more rigid in regions requiring structural support and more compliant in regions needing to adapt to anatomical variations. The self-expanding mechanism allows different sections of the frame to exert different radial forces based on local anatomical requirements while maintaining overall structural integrity.
Solution Approach 2:
The frame's physical parameters (radius, cell size, wire diameter) are optimized to provide consistent radial force across different anatomical configurations. The self-expanding mechanism transforms the frame from a compressed state with one set of parameters to an expanded state with optimized parameters for both conformance and rigidity.
4Reliability
If four commissure points are sewn to the frame, then valve stability and prevention of migration are improved, but device complexity and manufacturing difficulty increase
Solution Approach 1:
The commissure points are pre-formed and pre-positioned on the frame during manufacturing, with attachment holes and suture paths predetermined. This preliminary preparation simplifies the implantation process by eliminating the need for complex intraoperative commissure formation and ensures consistent positioning.
Solution Approach 2:
The frame serves as an intermediary structure that simplifies the attachment of leaflets to the valve prosthesis. The predetermined attachment holes in the frame provide a standardized interface for securing leaflets, reducing the complexity of creating secure attachments during implantation.
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 solution allows for minimally invasive, reliable valve replacement with reduced recovery time and risk, maintaining hemodynamic performance and extending the valve's operating life by minimizing stress and leaks, and facilitating quicker opening and closing.
Implementation Method 1
a self-expanding frame
Data Source
AI summary
Heart valve prostheses are provided having a self-expanding frame that supports a valve body comprising a skirt and a plurality of coapting leaflets. The leaflets are constructed with four commissure points to reduce the stress and strain applied to the commissure points and to efficiently distribute and transmit forces along the leaflets and to the frame.