Retrievable Filter for Heart Valve Debris Capture
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Solution Overview
Problem
Current medical devices for replacing heart valves are often invasive and lack effective solutions for capturing debris during deployment, which can lead to complications such as thrombus or calcification dislodgement.
Innovation Solution
A replacement heart valve system comprising an expandable framework with valve leaflets and a filter element that can be deployed downstream of the framework, capturing particulates while allowing blood to pass through, and is retrievable without removing the valve implant, thereby minimizing invasive procedures and debris-related risks.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a replacement heart valve implant is deployed to replace a defective valve, then the effectiveness of the heart valve is improved, but the risk of debris dislodgement (thrombus or calcification) increases
Solution Approach 1:
A filter element is introduced as an intermediary component between the delivery system and the replacement heart valve implant. The filter element captures debris during deployment and expansion of the valve, preventing thrombus or calcification from being dislodged into the bloodstream while allowing the valve to function effectively
2Reliability
If a filter element is added to capture debris during valve deployment, then the safety is improved, but the device complexity increases
Solution Approach 1:
The filter element is integrated with the delivery system and replacement heart valve implant as a combined assembly. The filter element is secured to the expandable framework and deployed in coordination with the valve implant, allowing debris capture functionality to be added without requiring separate independent devices or procedures
3Reliability
If the filter element is left in place permanently, then the debris capture function is maintained, but the invasiveness of the procedure increases
Solution Approach 1:
The filter element is designed with dynamic characteristics, allowing it to be deployed during the valve implantation procedure and then retrieved through the replacement heart valve implant after deployment is complete. This transforms the filter from a permanent to a temporary component, reducing procedural invasiveness while maintaining debris capture functionality when needed
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 system effectively captures debris during valve deployment and expansion, reducing the risk of thrombus or calcification dislodgement, and allows for minimally invasive procedures by enabling the filter element to be retrieved while the valve implant remains in place.
Implementation Method 1
the filter element is configured to capture particulates while permitting blood to pass through the filter element
Implementation Method 2
a replacement heart valve implant comprising an expandable framework and a plurality of valve leaflets disposed within the expandable framework
Implementation Method 3
the first end includes a first sealing element configured to engage native tissue upstream of the native heart valve and the second end includes a second sealing element configured to engage native tissue downstream of the native heart valve
Data Source
AI summary
A replacement heart valve system may include a replacement heart valve implant including an expandable framework and a plurality of valve leaflets disposed within the expandable framework, and a filter element secured to the expandable framework and configured to be deployed downstream of the expandable framework, the filter element having a closed downstream end. A replacement heart valve system may include a filter element configured to be deployed across a native heart valve, wherein the filter element includes a lumen extending therethrough, and a replacement heart valve implant configured to be deployed within the lumen of the filter element. A method of treating a native heart valve may include deploying a filter element across the native heart valve, expanding an expandable balloon within the lumen of the filter element, and thereafter, deploying a replacement heart valve implant within the lumen of the filter element.