Conical Foam Embolic Filter with Flexible Struts
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Solution Overview
Problem
Current medical devices for embolic protection during vascular procedures face challenges such as incomplete occlusion of blood flow, risk of emboli dislodgment during device deployment, and inadequate securing of the filter portion to the vessel wall, limiting their effectiveness and durability.
Innovation Solution
A medical device featuring a foam filter body with conical geometry and flexible struts that expand to secure against the vessel wall, allowing blood cells to pass while trapping emboli, and a core wire for transitioning between expanded and collapsed states to facilitate insertion and retrieval, with folds for minimizing profile and reducing emboli dislodgment risk.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Volume of moving object
If a filter device is deployed from the proximal side of a stenosis, then the profile of the filtering device must be smaller than the opening in the stenosed vessel, but this limits the filtering surface area and may increase the risk of emboli passing through
Solution Approach 1:
The filter device is divided into multiple struts that can be independently configured to provide both a small delivery profile and an expanded filtering surface. The struts are arranged to form a collapsible structure that segments the filtering function across multiple elements.
Solution Approach 2:
The filter device transitions from a compressed low-profile state during delivery to an expanded high-surface-area state during filtration. The struts are designed to dynamically change configuration, allowing the device to adapt its profile size while maintaining filtering effectiveness.
2Volume of moving object
If the filter portion is not held against the inside of the vessel wall, then the device profile can be smaller, but there is a risk that embolic material may pass between the filter and the vessel wall
Solution Approach 1:
The filter portion is constructed as a flexible porous structure that can conform to the vessel wall geometry. This flexible membrane design allows the filter to maintain contact with the vessel wall while preserving a compact profile when collapsed.
Solution Approach 2:
The filter dynamically adjusts its position and contact with the vessel wall based on deployment state. During delivery, the flexible filter maintains minimal contact to preserve low profile; during operation, it expands to contact the vessel wall and prevent emboli passage.
3Strength
If the filter portion is firmly secured to the medical device, then durability is improved, but any damage to the medical device during deployment increases the risk that emboli might breach the medical device
Solution Approach 1:
The filter is segmented into multiple struts that are individually attached to the medical device. This segmentation allows the filter to remain durable through multiple attachment points while isolating potential failure points, so that damage to one strut does not compromise the entire embolic protection system.
4Reliability
If a balloon is used to occlude blood flow downstream of the stenosed area, then emboli can be captured, but the vessel is occluded completely for short periods of time, limiting use of the procedure
Solution Approach 1:
The filter device uses porous material that allows blood cells to pass through while trapping emboli. This selective permeability enables continuous blood flow to be maintained during the procedure, eliminating the need for complete vessel occlusion and extending the duration for which the procedure can be performed.
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 during procedures by securely expanding against the vessel wall, minimizing the risk of emboli dislodgment during deployment and retrieval, and ensuring durable performance by using shape memory materials for self-expanding and collapsing functionality.
Implementation Method 1
The filter portion has pores sized such that blood cells can pass through the foam body, but larger material such as emboli are trapped in the recess
Implementation Method 2
The struts are biased into an expanded state such that the filter portion is forced against an inner wall of the vessel. The core wire may be moved relative to the struts forcing the basket into a collapsed state
Data Source
AI summary
An embolic protection device includes a foam body attached to a plurality of flexible struts. The foam body has a generally conical geometry and the bottom of the conical geometry having a generally conical recess. The filter portion has pores sized such that blood cells can pass through the foam body, but larger material such as objects would be trapped in the recess. Each strut is attached along the periphery of the foam body and extend from the first end of the foam body to a connection point located proximate the first end.