Intra-Annular Sealing Cuff 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 ring 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
1Ease of operation
If a collapsible prosthetic heart valve is used to enable minimally invasive delivery, then the invasiveness of the procedure is reduced, but perivalvular leakage occurs due to improper fitment
Solution Approach 1:
The sealing structure is divided into multiple sealing members distributed around the circumference of the stent, with each sealing member independently capable of deforming to conform to the native annulus. This segmentation allows each element to adapt to local anatomical variations, improving overall sealing effectiveness while maintaining the collapsible design for minimally invasive delivery.
Solution Approach 2:
The sealing members are designed to be deformable rather than rigid, allowing them to dynamically adapt their shape and position to match the contours of the native valve annulus. This dynamic capability enables the sealing structure to compensate for anatomical variations and calcification, preventing perivalvular leakage while maintaining the minimally invasive delivery advantage.
2Stability of the object's composition
If the sealing structure is made rigid to ensure secure anchoring, then anchoring stability is improved, but the ability to conform to anatomical variations is reduced
Solution Approach 1:
Different regions of the sealing structure have different degrees of flexibility tailored to local requirements. The sealing members are designed with varying stiffness characteristics that allow them to conform to specific anatomical features while maintaining overall anchoring stability. This local differentiation enables the structure to adapt to anatomical variations without sacrificing the stability needed for secure anchoring.
Solution Approach 2:
The sealing members are constructed from composite materials that combine rigidity and flexibility properties. This composite construction allows the sealing structure to maintain sufficient stiffness for secure anchoring while simultaneously possessing the flexibility needed to conform to anatomical variations, resolving the contradiction between stability and adaptability.
3Volume of moving object
If the stent is made collapsible to reduce circumferential size for delivery, then the delivery invasiveness is reduced, but the fitment precision at the implant site is compromised
Solution Approach 1:
The sealing members are pre-formed with specific deformable characteristics during manufacturing, but their final conformal position is determined by the implantation environment. This preliminary preparation combined with post-implant adaptation allows the stent to achieve precise fitment at the implant site while maintaining a compact collapsible size for minimally invasive delivery.
Solution Approach 2:
The stent and sealing members undergo parameter changes in their physical state between delivery and implantation. The collapsible design allows the stent to be compressed to a small circumferential size for delivery, then expand and conform to the native annulus at the implant site. This parameter transformation enables both minimally invasive delivery and precise fitment.
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 minimizing the need for valve removal, thus reducing procedural complexity and risks.
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.