Invertible Embolic Filter Eversion Design
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Solution Overview
Problem
Current medical devices for embolic protection face challenges such as risk of dislodging emboli during insertion, incomplete capture of embolic material, and compromised blood flow due to filter design, particularly when deploying from the proximal side of a stenosis.
Innovation Solution
A medical device featuring a guiding member and a filter portion with a tubular geometry that evverts to form a concave shape, allowing blood cells to pass while capturing emboli, and utilizing control wires and shape memory alloys for deployment and retrieval, ensuring the filter expands to engage the vessel wall and maintain blood flow.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Object-affected harmful factors
If the filter portion is made with a small profile to deploy from the proximal side of stenosis, then the risk of dislodging emboli during insertion is reduced, but the filter may not be held against the vessel wall effectively, allowing embolic material to pass between the filter and vessel wall
Solution Approach 1:
The filter portion is designed to dynamically change its configuration from a compressed low-profile state during insertion to an expanded state during operation. The expandable structure allows the filter to adapt to the vessel wall after deployment, ensuring effective emboli capture while maintaining a low profile during insertion to minimize dislodgement risk
Solution Approach 2:
The filter portion is nested within the guiding member during insertion, allowing the filter to be delivered through the guiding member's lumen in a compressed state. After deployment, the filter expands beyond the guiding member to engage the vessel wall, effectively capturing emboli while maintaining a small insertion profile
2Reliability
If the filter portion is expanded to engage the vessel wall for effective emboli capture, then embolic protection is improved, but blood flow through the filtering device may be compromised when the filter becomes filled with particles
Solution Approach 1:
The filter portion is designed with a concave collection area that extends in a different spatial dimension from the vessel wall. This dimensional arrangement creates a three-dimensional collection space for emboli while maintaining open pathways for blood flow through the filter mesh, allowing the filter to capture emboli without completely blocking blood flow
3Reliability
If a balloon is used to occlude blood flow through the vessel to prevent emboli, then embolic protection is achieved, but the vessel may be occluded only for short periods of time, limiting use of the procedure
Solution Approach 1:
The patent replaces the mechanical balloon occlusion system with a filtering device that passively captures emboli through a mesh structure. This substitution allows for prolonged embolic protection without the time limitations of balloon occlusion, as the filter continuously captures emboli while maintaining blood flow through the vessel
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 device effectively captures emboli, reduces the risk of dislodging during insertion, and ensures uninterrupted blood flow by arranging collected emboli in a ring-shaped collection area spaced from the vessel wall, facilitating safe removal and minimizing the risk of ischemic stroke.
Implementation Method 1
The filter portion including the mesh material may be made of a shape memory alloy to facilitate the everting of the filter portion into the proximally facing concave geometry
Data Source
AI summary
A medical device including a guiding member and a filter portion is disclosed. The guiding member includes a lumen configured to slidably engage the filter portion. The filter portion forms a tubular geometry that extends distally from the guiding member. The filter portion is configured to evert to form a proximally facing concave geometry for capturing emboli. Further, the filter portion includes filter openings that are sized to allow blood cells to pass therethrough while preventing the passage of emboli.