Collapsible Heart Valve Cuff Structure for Paravalvular Leak Mitigation
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Solution Overview
Problem
Collapsible prosthetic heart valves experience paravalvular leaks due to imperfect sealing between the implanted valve and native tissue, leading to retrograde blood flow and reduced cardiac performance.
Innovation Solution
The prosthetic heart valve incorporates an outer cuff with fingers or additional struts that extend radially outward to fill gaps between the valve and native tissue, and a second cuff positioned radially outward of the first cuff to enhance sealing, minimizing paravalvular leaks.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Object-affected harmful factors
If a collapsible prosthetic valve is delivered via catheter to minimize invasiveness, then patient trauma is reduced, but the valve structure becomes more complex requiring additional components for collapse and expansion
Solution Approach 1:
The valve is divided into multiple segments including a collapsible stent frame with interconnected struts and cells, allowing the structure to be broken down into smaller movable units that can be compressed for delivery and expanded for function
Solution Approach 2:
The collapsible valve is nested within a delivery catheter in a compressed state, with the stent, leaflets, and sealing components arranged in a compact configuration that fits within the catheter lumen, then deployed at the target site
2Ease of operation
If the valve is made collapsible for easier delivery, then delivery ease is improved, but sealing performance deteriorates due to gaps between the valve and native tissue
Solution Approach 1:
A sealing cuff or annular sealing member is introduced as an intermediary component between the collapsible stent frame and the native tissue, providing a dedicated sealing interface that compensates for gaps created by the collapsible structure
Solution Approach 2:
The sealing cuff is made of flexible material that can conform to the native tissue surface, creating an effective seal while allowing the underlying stent to maintain its collapsible geometry for delivery
3Reliability
If sealing components are added to reduce paravalvular leaks, then sealing performance is improved, but device complexity increases
Solution Approach 1:
The sealing cuff is integrated with the stent frame structure, with the cuff attached to and moving with the stent struts, combining the support function of the stent with the sealing function of the cuff into a unified component system
Data Source
AI summary
A prosthetic heart valve includes a collapsible stent and a valve assembly disposed within the stent. A first cuff is disposed adjacent the stent. A second cuff having a distal edge facing the outflow end of the stent is disposed about the stent radially outward of the first cuff and the stent. The stent may include a plurality of fingers each having a first end coupled to a corresponding cell of the stent and a free end adapted to extend radially outward of the corresponding cell. The distal edge of the second cuff may be coupled to the fingers at spaced locations around the circumference of the stent to position the distal edge radially outward from the corresponding cells at the spaced locations. Various stent struts may be tapered to reduce the stent circumference in the collapsed condition, and to improve the fatigue resistance and/or bendability of the stent.