Collapsible Embolic Protection Frame for Vessel Sealing
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Solution Overview
Problem
Current distal embolic protection devices often fail to completely open within the blood vessel, leaving gaps that allow blood clots and thrombi to escape, compromising downstream blood flow during procedures like carotid angioplasty.
Innovation Solution
An embolic protection device with a collapsible frame that expands into a torus-shaped configuration using fluid inflation or a wire to ensure a fluid-tight seal with the vessel wall, featuring a guide wire for navigation and radiopaque markers for localization, and optionally a second frame for enhanced debris capture.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If the filter device is advanced downstream of the treatment site, then the device can capture embolic debris, but the device may fail to completely open within the blood vessel, leaving gaps that allow debris to escape
Solution Approach 1:
The frame is designed to be collapsible and expandable, transitioning from a collapsed delivery state to an opened operational state. This dynamic structure allows the filter to adapt to the blood vessel environment, ensuring complete opening and sealing against the vessel wall to prevent debris escape while maintaining delivery capability.
Solution Approach 2:
The frame's physical state changes from collapsed to opened through controlled expansion, altering its geometric parameters to achieve full deployment. This parameter transformation ensures the filter reaches its operational configuration where it can effectively capture embolic debris without leaving gaps.
2Ease of operation
If the frame is made collapsible for delivery, then the device can be easily positioned, but the frame must be reliably opened to prevent gaps
Solution Approach 1:
The collapsible frame structure enables easy delivery through the blood vessel in a compact configuration, then reliably opens to its operational shape at the target location. This dynamic capability resolves the contradiction by providing both delivery convenience and operational reliability through the same structural design.
Solution Approach 2:
The frame is pre-configured in a collapsed state for easy delivery and positioning, then systematically opened to its operational configuration before engaging with the vessel wall. This preliminary preparation ensures both ease of delivery and reliable opening without compromising either aspect.
3Device complexity
If gaps are left between the filter and vessel wall, then the filter structure remains simple, but blood clots can flow past the filter unoccluded
Solution Approach 1:
The frame dynamically expands to engage the vessel wall, creating a sealed interface between the filter and the blood vessel. This dynamic engagement eliminates gaps that would allow unoccluded clot flow, while the overall structure remains relatively simple without requiring complex additional sealing mechanisms.
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
Effectively captures embolic debris while minimizing the risk of downstream embolism by ensuring a secure, expanded position within the blood vessel, reducing the likelihood of clot release during stenosis treatments.
Implementation Method 1
The tube portion may be composed of a generally elastic material to further permit the expansion. The fluid may also be used in the above-described design having first and second frames.
Implementation Method 2
The tube portion may be composed of a generally elastic material to further permit the expansion.
Data Source
AI summary
An embolic protection device is provided for deployment within a body vessel to collect embolic debris there from. The device includes a filter for collecting the embolic debris and a frame for supporting the filter. The frame generally defines a closed loop that has a collapsed state and an opened state. Furthermore, the frame includes a tube portion that receives an opening means to open the closed loop from the collapsed state to the opened state.