Aortic Valve Prosthesis Radial Force Adaptation
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Solution Overview
Problem
Current implantable medical devices for repairing damaged aortic valves face challenges in replicating the natural valve's size, shape, and function, leading to issues like valve leakage and heart failure due to unpredictable balloon dilation and varying radial force requirements.
Innovation Solution
A valve design with a proximal cylindrical region, a distal rectangular region, and a tapered transition, featuring reinforcement strips that vary in shape and orientation to enhance structural integrity and prevent prolapse, coupled with a stent structure that adjusts radial force along its length to better interact with the patient's anatomy.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Manufacturing precision
If a balloon-expandable stent is used to place an artificial valve, then the valve can be implanted at the site of the defective aortic valve, but the size of the implantation site becomes unpredictable due to balloon dilation of a heavily calcified native valve and its annulus
Solution Approach 1:
The stent is designed with different radial force characteristics at different locations along its length. The proximal portion has different expansion properties than the distal portion, allowing each section to optimally interact with the specific anatomical features at that location, such as the calcified annulus and vessel wall
Solution Approach 2:
The stent is divided into multiple segments or sections (proximal and distal portions) that can be independently designed with different radial forces, allowing customized adaptation to varying anatomical conditions at different implantation sites
2Reliability
If different radial force considerations are applied at different locations, then the prosthesis can optimally interact with patient anatomy, but the device complexity increases
Solution Approach 1:
The stent incorporates varying radial force characteristics at different locations through its structural design, allowing optimal interaction with patient anatomy at each site while maintaining overall device functionality and reliability
3Reliability
If reinforcement strips are added to the valve leaflets, then the valve can be biased closed and prolapse is prevented, but the device complexity increases
Solution Approach 1:
The valve incorporates reinforcement strips that combine different material properties with the valve leaflets, creating a composite structure that provides both the flexibility needed for natural valve motion and the strength required to prevent prolapse and maintain proper closure bias
Data Source
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AI summary
A valve (120) for implantation in a patient comprises a proximal region (130) comprising a cylindrical shape, and a distal region (170) having a generally rectangular shape comprising opposing flat surfaces (172, 174) that are separated by narrower flat sides (175a, 175b). A tapered region (150) is disposed between the proximal and distal regions, where the tapered region comprises two opposing flat surfaces (152, 154) that transition into the opposing flat surfaces of the distal region. The opposing flat surfaces of the tapered region are angled relative to the proximal and distal regions. The opposing flat surfaces at the distal end of the valve allow fluid flow therethrough during antegrade flow and are generally adjacent to one another to inhibit blood flow through the valve during retrograde flow. Optionally, at least one reinforcement member (185) may be coupled to the valve to prevent prolapse of the valve during retrograde flow.