Active Channel-Filling Cuffs for Prosthetic Valve PVL Reduction
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Solution Overview
Problem
Conventional collapsible prosthetic heart valves face issues with perivalvular leakage and improper fitment due to anatomical variations and calcification, leading to reduced cardiac efficiency and increased procedural risks.
Innovation Solution
The design incorporates a sealing structure with a collapsible and expandable stent and a sealing member that expands to fill gaps between the prosthetic heart valve and the native aortic annulus, featuring a porous material for unidirectional blood flow and stored energy elements to ensure secure anchoring and sealing.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Object-affected harmful factors
If a collapsible prosthetic heart valve is delivered via catheter, then the invasiveness of the procedure is reduced, but the risk of perivalvular leakage increases due to anatomical variations and calcification
Solution Approach 1:
The sealing member is designed with non-uniform thickness, having a first thickness at the proximal end and a second thickness at the distal end, allowing different regions to provide different sealing functions. The variable thickness profile enables the sealing member to adapt to local anatomical variations and calcification patterns in the aortic annulus, improving sealing effectiveness without increasing overall device complexity
Solution Approach 2:
The sealing member transitions from a compressed state during delivery to an expanded state after implantation, dynamically adapting to the native aortic annulus geometry. This dynamic expansion allows the sealing member to conform to anatomical variations and calcification, reducing perivalvular leakage while maintaining low invasiveness during the delivery phase
2Reliability
If the sealing member is made thicker to improve sealing, then perivalvular leakage is reduced, but the device complexity and delivery difficulty increase
Solution Approach 1:
The sealing member is divided into distinct regions with different thicknesses - a proximal region and a distal region, each optimized for specific sealing functions. This segmentation allows the thicker portions to provide enhanced sealing where needed while thinner portions facilitate delivery, reducing overall device complexity compared to a uniformly thick design
Solution Approach 2:
The thickness parameter of the sealing member is varied along its length, transitioning from a first thickness at the proximal end to a second thickness at the distal end. This parameter change enables the sealing member to provide enhanced sealing effectiveness in specific regions while maintaining deliverability and reducing overall structural complexity
3Reliability
If the sealing member extends further from the prosthetic valve, then sealing contact area is increased, but the risk of interfering with native leaflets increases
Solution Approach 1:
The sealing member is positioned and dimensioned to extend into the aortic annulus region without contacting the native leaflets during valve closure. The local geometry and placement strategy ensure adequate sealing contact area in the annular region while maintaining clearance from the native leaflet tissue, eliminating interference risks
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 reduces the likelihood of perivalvular leakage and improves the fitment of prosthetic heart valves, enhancing cardiac efficiency and reducing the need for valve removal, thereby minimizing procedural risks and complications.
Implementation Method 1
The top surface of the sealing structure may include a porous material having a multitude of small apertures adapted to allow unidirectional blood flow into an interior of the sealing structure
Implementation Method 2
at least one stored energy element biased to provide a force to the sealing structure away from the cuff in a radial direction orthogonal to the flow direction when at least a portion of the sealing structure is radially compressed toward the cuff
Data Source
AI summary
A prosthetic heart valve may include a collapsible and expandable stent extending in a flow direction between a proximal end and a distal end, a cuff attached to an annulus section of the stent and having an outer surface facing in a radial direction orthogonal to the flow direction, a plurality of prosthetic valve leaflets attached to the cuff, and a sealing structure attached to the annulus section of the stent at an inner edge of the sealing structure. The flow direction may be defined from the proximal end toward the distal end. The sealing structure may have an outer edge remote from the inner edge. The sealing structure may have a collapsed condition with the outer edge disposed adjacent the outer surface of the cuff and an expanded condition with the outer edge spaced apart from the outer surface of the cuff.