Everted Membrane Clot Capture Device for Stroke Reperfusion
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Solution Overview
Problem
Current treatments for acute ischemic stroke, such as the Merci device, are limited in their ability to capture and remove blood clots in their entirety without fragmenting, often leading to complications like vessel dissection, perforation, and hemorrhage, and require multiple passes through the vessel, which can cause new strokes and are not effective in all cases.
Innovation Solution
A catheter-based system that includes a microcatheter and a capturing device with an everted or basket-like structure, capable of deploying a reperfusion/clot removal device that engages and removes emboli without fragmenting, using a process that involves accessing the artery, locating the embolus, reperfusing the vessel, and removing the embolus while maintaining arterial access to prevent further complications.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If current clot removal devices (e.g., Merci device) are used to capture and remove blood clots, then embolus removal is achieved, but the clots are fragmented during removal, leading to vessel dissection, perforation, and hemorrhage
Solution Approach 1:
The capturing device employs an everted distal tip formed from a flexible membrane that can invert inside out. This flexible membrane structure allows the device to engage and capture clots gently without rigid mechanical contact that would cause fragmentation and vessel damage, while still maintaining effective clot removal capability
Solution Approach 2:
The distal tip of the capturing device is everted (turned inside out) to form a cup-like structure. This inversion transforms the sharp, potentially damaging tip into a rounded, compliant capturing surface that can envelop clots without fragmenting them, thereby reducing vessel damage while maintaining removal effectiveness
2Reliability
If multiple passes through the vessel are performed to remove clots, then complete embolus removal is achieved, but new strokes occur and vessel integrity is compromised
Solution Approach 1:
The capturing device is designed with an everted distal tip that can be positioned and engaged with the clot in a single pass. The pre-formed cup-like structure allows immediate clot capture upon deployment, eliminating the need for multiple retrieval passes that would expose the vessel to repeated manipulation and increase the risk of new strokes and vessel damage
3Productivity
If aggressive clot removal techniques are used to ensure complete embolus removal, then clot clearance is improved, but vessel dissection and perforation occur
Solution Approach 1:
The flexible membrane forming the everted distal tip provides a compliant, non-rigid structure that can adapt to the clot shape and vessel geometry. This flexibility allows efficient clot engagement and capture without the need for aggressive forceful extraction, thereby achieving complete clot clearance while preventing vessel dissection and perforation
Data Source
AI summary
Devices for restoring blood flow to facilitate lysis of clots and/or enable capture of clots are disclosed. The devices can be configured to be disposed within a lumen of a microcatheter that is inserted within neurovasculature above a carotid siphon to a location of a clot. The devices can include an elongate pusher member and a self-expandable capturing member coupled to a distal end of the elongate pusher member. The capturing member can comprise a generally cylindrical body having an cell structure that is configured to compress the clot against an inner wall of the neurovasculature and capture the clot at least partially on a surface of the generally cylindrical body upon deployment of the capturing member from the microcatheter, thereby restoring blood flow to the neurovasculature downstream of the clot.