Intravascular Cuff Traps Leaflets to Seal Prosthetic Valves
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Solution Overview
Problem
Percutaneous valve replacement methods face challenges such as leakage around the prosthetic valve, stent-related emboli, non-conformity to native lumen features, and difficulty in centering stents within irregularly shaped valves, leading to inefficiencies and complications in valve implantation.
Innovation Solution
A tubular or toroidal cuff made of super-elastic or shape memory material, like Nitinol, is used to surround the native valve, creating an ideal implantation site by curling back to trap leaflets and provide a defined lumen for prosthetic device placement, while preventing leakage and emboli through its braided structure.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Strength
If a stent is used as support scaffolding for the prosthetic valve, then structural support is provided, but emboli are created and leakage around the valve occurs
Solution Approach 1:
The patent removes the stent component from the prosthetic valve assembly entirely. The valve is deployed without any stent scaffolding, eliminating the source of emboli generation while maintaining structural integrity through alternative design features of the valve framework itself.
Solution Approach 2:
The patent introduces a sealing mechanism that acts as an intermediary between the prosthetic valve and the native valve annulus. This sealing component prevents leakage around the valve interface without requiring a stent, mediating the connection while eliminating harmful effects.
2Reliability
If the prosthetic valve is expanded against the lumen wall to excise the native valve, then valve replacement is achieved, but sealing around the interface becomes difficult
Solution Approach 1:
A dedicated sealing component is introduced as an intermediary element between the prosthetic valve and the native annulus. This sealing structure fills irregularities in the interface geometry, ensuring reliable sealing without requiring precise manufacturing tolerances on the valve components themselves.
Solution Approach 2:
The sealing mechanism utilizes flexible membrane structures that can conform to the irregular geometry of the native valve annulus. These thin film structures adapt to surface variations, ensuring effective sealing despite manufacturing tolerances or anatomical irregularities.
3Strength
If a stent is used to house the prosthetic valve, then structural support is provided, but the stent does not conform to native lumen features
Solution Approach 1:
The stent is completely removed from the design, eliminating the conformality problem entirely. The prosthetic valve is deployed directly against the native annulus without an intermediate stent structure, allowing direct adaptation to native lumen features.
Solution Approach 2:
The valve framework utilizes flexible structural elements that can conform to the native lumen geometry. The sealing component employs thin film structures that adapt to irregular surfaces, providing both structural support and anatomical conformity without requiring a rigid stent.
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 cuff ensures secure placement and sealing of prosthetic valves, reduces the risk of emboli, and adapts to irregular valve shapes, enhancing the effectiveness and safety of percutaneous valve replacement procedures.
Implementation Method 1
A tubular or toroidal cuff made of super-elastic or shape memory material, like Nitinol, is used to surround the native valve, creating an ideal implantation site by curling back to trap leaflets
Implementation Method 2
A tubular or toroidal cuff made of super-elastic or shape memory material, like Nitinol, is used to surround the native valve
Data Source
AI summary
An intravascular cuff acts as a lining between a native vessel and an intravascular prosthetic device. During deployment, the ends of the cuff curl back upon themselves and are capable of trapping native tissue, such as valve leaflet tissue, between the ends. The cuff creates a seal between the vessel and the prosthetic, thereby preventing leakage around the prosthetic. The cuff also traps any embolic material dislodged from the vessel during expansion of the prosthetic.