Irregular Sealing Cuff Anchoring for Prosthetic Heart Valve Leakage
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Solution Overview
Problem
Conventional collapsible prosthetic heart valves face challenges with accurate deployment and anchoring, leading to risks such as valve migration, perivalvular leakage, and reduced cardiac efficiency due to improper fitment with native valve annuli, especially in cases of uneven calcification and anatomical variations.
Innovation Solution
A prosthetic heart valve design featuring a collapsible and expandable stent with a sealing structure that includes a cuff, underwire, and various sealing ring configurations to ensure secure anchoring and sealing between native leaflets, reducing the need for excessive radial force and accommodating anatomical irregularities.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If conventional collapsible prosthetic heart valves are deployed, then the valve can be delivered less invasively via catheter, but the valve may migrate or cause perivalvular leakage due to inaccurate anchoring
Solution Approach 1:
The sealing structure is pre-formed with an irregular configuration that matches the expected anatomical variations of the native valve annulus. This preliminary shaping allows the valve to automatically conform to the annular geometry upon deployment, eliminating the need for post-deployment adjustment and preventing migration and perivalvular leakage.
Solution Approach 2:
The sealing structure features varying heights and configurations at different locations around the annulus, with higher portions positioned to accommodate areas of uneven calcification or anatomical irregularities. This localized adaptation ensures optimal sealing at each specific site, improving anchoring accuracy without compromising the overall less invasive delivery approach.
2Device complexity
If conventional prosthetic valves are deployed, then the valve structure is simple, but the fitment with native valve annuli is improper leading to perivalvular leakage
Solution Approach 1:
The sealing structure incorporates an irregular configuration with varying heights around the annulus, where higher portions are strategically positioned to accommodate areas of uneven calcification or anatomical irregularities. This localized adaptation ensures optimal sealing at each specific site, improving sealing performance without requiring excessive structural complexity throughout the entire valve.
Solution Approach 2:
The sealing structure is designed to dynamically adapt to the native valve annulus geometry upon deployment, with the ability to conform to irregular surfaces and accommodate anatomical variations. This dynamic adaptation capability improves sealing performance by ensuring proper fitment with the unique anatomy of each patient's valve annulus.
3Reliability
If excessive radial force is applied during deployment, then the valve can be anchored securely, but the risk of damaging native tissue increases
Solution Approach 1:
The sealing structure is pre-formed with an irregular configuration that allows it to self-anchor into the native valve annulus without requiring excessive radial force. The pre-shaped higher portions engage with areas of uneven calcification or anatomical irregularities, providing secure anchoring through mechanical interlocking rather than forceful compression, thereby reducing the risk of damaging native tissue.
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, a plurality of prosthetic valve leaflets each having a belly attached to the cuff between a first location and a second location downstream of the first location in a flow direction, and a sealing structure attached to the annulus section of the stent. The annulus section of the stent may be adjacent the proximal end. The stent may include a plurality of struts shaped to form a plurality of cells connected to one another in a plurality of annular rows around the stent. The sealing structure may have a deployed condition with a diameter greater than a diameter of the proximal end of the stent when the stent is in an expanded use condition.