Self-orienting Nitinol Mitral Valve Prosthesis
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Solution Overview
Problem
Current cardiac valve prostheses are difficult to place correctly within the native mitral valve, are challenging to size appropriately, and are hard to retrieve and replace if initially placed incorrectly, especially when using minimally invasive techniques.
Innovation Solution
A flexible, self-orienting cardiac valve prosthesis with a proximal and distal anchor, a central column, and leaflets, made from superelastic nitinol, which can be delivered through minimally invasive techniques and securely anchored within the mitral valve orifice using radial force and tissue engagement.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Object-affected harmful factors
If current cardiac valve prostheses are delivered via minimally invasive device, then the procedure is less traumatic and avoids extra-corporeal perfusion, but the prosthesis is difficult to place correctly, difficult to size to native valve, and difficult to retrieve and replace if placed incorrectly
Solution Approach 1:
The prosthesis employs a dynamic delivery system where the prosthetic valve and anchor are delivered in a compressed state through a catheter, then expanded at the target site. The anchor can be deployed independently first to establish positioning, followed by the prosthetic valve expansion, allowing for dynamic adjustment and repositioning if needed before final fixation
Solution Approach 2:
The system is divided into separate functional components: a delivery catheter, an expandable anchor, and a prosthetic valve. This segmentation allows the anchor to be deployed first to secure positioning, then the valve to be expanded within the anchored structure, enabling independent optimization of each component's placement and retrieval characteristics
2Stability of the object's composition
If prosthesis is securely anchored within mitral valve orifice using radial force, then placement stability is improved, but ability to reposition or retrieve becomes more difficult
Solution Approach 1:
The anchor is deployed first as a preliminary action to establish the positioning framework before the prosthetic valve is expanded. This sequence allows the anchor to be positioned and secured independently, providing a stable foundation that can be adjusted before final valve deployment, thereby maintaining repositioning capability while ensuring eventual stability
3Ease of operation
If prosthesis is made flexible and self-orienting using superelastic nitinol, then ease of delivery through minimally invasive technique is improved, but structural strength for secure anchoring becomes challenging
Solution Approach 1:
The prosthesis utilizes superelastic nitinol material that exhibits different mechanical properties at different states: during delivery, the material's flexibility and superelasticity allow compression and navigation through small catheters; upon deployment, the material's shape memory and elastic recovery provide the structural strength needed for radial expansion and secure anchoring within the mitral valve orifice
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 prosthesis effectively secures itself within the mitral valve orifice, ensuring proper placement, sizing, and stability, while allowing for repositioning and re-deployment if necessary, thus overcoming the limitations of existing technologies.
Implementation Method 1
A flexible, self-orienting cardiac valve prosthesis with a proximal and distal anchor, a central column, and leaflets, made from superelastic nitinol
Data Source
Figure 1A
Figure 1B
Figure 1C
AI summary
A prosthetic mitral valve (100) includes a proximal anchor (2), a distal anchor (3), and a central portion (4) therebetween. The proximal and distal anchors each include a first outer frame and a second outer frame. The first outer frame includes a plurality of first arcs joined together, and the second outer frame includes a plurality of second arcs joined together. The plurality of first arcs are out of phase relative to the plurality of second arcs.The frame comprises retention hooks (21) for gripping cardiac tissue. n