Integrated Cuff for Balloon Expandable Heart Valves
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Solution Overview
Problem
Existing collapsible/expandable prosthetic heart valves for transcatheter aortic and mitral valve replacement face challenges in minimizing paravalvular leakage and optimizing the assembly process for accurate and reproducible deployment.
Innovation Solution
The method involves pre-assembling prosthetic leaflets to a cuff, which is then coupled to a stent, with specific stitching techniques to secure the cuff and leaflets, allowing for a more efficient and accurate assembly process that reduces the need for an inner cuff and minimizes bulk, thereby enhancing sealing and deployment precision.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a traditional multi-component cuff assembly is used, then sealing capability is improved, but device complexity and bulk increase
Solution Approach 1:
The patent merges the inner cuff and outer cuff into a single integrated cuff structure with a unified body. The cuff includes an inner surface and outer surface with continuous material formation, eliminating the need for separate inner and outer cuff components while maintaining the sealing functionality against paravalvular leakage.
Solution Approach 2:
The single cuff structure performs multiple functions simultaneously: it provides sealing against paravalvular leakage, supports the leaflets during deployment, and interfaces with both the delivery catheter and the native annulus. The cuff's body serves as both the inner cuff (supporting leaflets) and outer cuff (sealing against annulus) without requiring separate components.
2Reliability
If a larger profile valve assembly is used, then sealing and structural support are improved, but delivery difficulty increases
Solution Approach 1:
The valve assembly transitions from a compressed delivery profile to an expanded deployed profile. The stent and cuff are designed to be compressible during delivery through the catheter, then expand upon deployment to provide adequate structural support and sealing capability without requiring a permanently large profile.
Solution Approach 2:
The valve assembly with stent and cuff is nested within the delivery catheter during transport. The entire prosthetic valve structure is contained within the catheter lumen in a compressed state, allowing delivery through small access vessels, then expands in situ to provide full structural support.
3Reliability
If an inner cuff is included, then leaflet support is improved, but manufacturing complexity increases
Solution Approach 1:
The inner cuff functionality is merged into the single cuff structure. The inner surface of the cuff provides leaflet support while the outer surface provides sealing, eliminating the need for a separate inner cuff component and simplifying the manufacturing process to a single cuff assembly operation.
4Manufacturing precision
If extensive stitching is used to secure cuff and leaflets, then assembly accuracy is improved, but manufacturing time increases
Solution Approach 1:
The leaflets are pre-attached to the cuff structure before final assembly with the stent. This preliminary attachment ensures proper positioning and alignment of leaflets relative to the cuff, maintaining assembly accuracy while reducing the complexity and time of the final assembly process.
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
This approach improves the sealing efficacy by reducing paravalvular leakage and allows for a smaller profile for delivery, facilitating easier and more precise deployment of the prosthetic heart valve.
Implementation Method 1
the balloon is inflated to force the balloon-expandable valve to transition from the collapsed or crimped condition into an expanded or deployed condition
Implementation Method 2
the prosthetic heart valve tending to remain in the shape into which it is expanded by the balloon
Data Source
AI summary
A method of manufacturing a prosthetic heart valve includes coupling a plurality of prosthetic leaflets to each other, and coupling the plurality of prosthetic leaflets to a cuff, to form a valve assembly. The valve assembly may be coupled to a stent to form the prosthetic heart valve. The valve assembly may be formed prior to the plurality of prosthetic leaflets being coupled to the stent and prior to the cuff being coupled to the stent.