Thromboembolic Separator for Stroke Aspiration
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Solution Overview
Problem
Current methods for treating ischemic stroke, such as pharmacological and mechanical elimination of thromboembolic material, are inefficient and pose risks due to long treatment times, potential for bleeding, and damage to cerebral vessels, with existing mechanical techniques showing modest success and risks of further strokes.
Innovation Solution
A system comprising an elongate catheter with an expandable and collapsible separator element and a retriever that can be deployed to engage and aspirate thromboembolic material, allowing for temporary restoration of blood flow and complete removal of the blockage, while being trackable through the cerebrovasculature and deployable at the site of occlusion.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If pharmacological treatment with thrombolytics and anticoagulants is used to eliminate thromboembolism, then the thromboembolism can be dissolved and blood flow restored, but the treatment takes a relatively long time and increases the potential for bleeding or hemorrhaging elsewhere in the body
Solution Approach 1:
The device segments the thrombus into multiple parts using a rotating blade that fragments the occlusive material, allowing each segment to be separately aspirated through the catheter lumen. This segmentation enables complete removal of the thromboembolism while reducing the time required compared to pharmacological dissolution.
2Reliability
If pharmacological treatment with thrombolytics and anticoagulants is used to eliminate thromboembolism, then the thromboembolism can be dissolved and blood flow restored, but the potential for bleeding or hemorrhaging elsewhere in the body is heightened
Solution Approach 1:
The device extracts the thromboembolism from the blood vessel through mechanical aspiration, removing the occlusive material entirely rather than dissolving it pharmacologically. This extraction method eliminates the need for thrombolytics and anticoagulants, thereby avoiding the heightened bleeding risk associated with these medications while still restoring blood flow.
3Loss of time
If a coil is deployed into a thromboembolism to ensnare or envelope it for removal, then mechanical elimination is achieved, but the thromboembolic material may slip past or become dislodged by the coil, potentially leading to an additional stroke
Solution Approach 1:
The device performs preliminary fragmentation of the thrombus using a rotating blade before aspiration, breaking the thrombus into smaller segments that can be more effectively captured and removed. This preliminary action ensures that the thromboembolic material is properly prepared for removal, reducing the risk of slippage or dislodgement during the aspiration process and improving overall success rates.
4Loss of time
If a basket or net structure is deployed distally from the thromboembolism to ensnare or envelope it for removal, then mechanical elimination is achieved, but the manipulation without angiographic roadmap visualization increases the danger of damaging the vessel
Solution Approach 1:
The device uses a rotating blade as an intermediary mechanism to fragment the thrombus before aspiration, rather than directly manipulating the thrombus with a basket or net structure. This intermediary approach allows for controlled fragmentation without the need for complex distal manipulations that could damage the vessel, especially when used in conjunction with angiographic roadmap visualization for precise positioning.
5Productivity
If a rotating blade is employed to sever or fragment the thromboembolism to augment aspiration effectiveness, then the effectiveness of aspiration is improved, but the danger of damaging the vessel increases
Solution Approach 1:
The rotating blade is designed with localized cutting edges and a specific geometry that concentrates the cutting action only at the tip where it contacts the thrombus, while the shaft and other portions remain smooth and non-traumatic. This local quality ensures that fragmentation effectiveness is maximized at the thrombus site without increasing the overall danger of vessel damage during advancement or manipulation within the vasculature.
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 restores blood flow, minimizes cell death, and facilitates the permanent removal of thromboembolic material with reduced risk of vessel damage and further strokes, by using an expandable retriever to aspirate and remove occlusions from cerebral arteries.
Implementation Method 1
aspirating the thromboembolic material into the catheter
Data Source
AI summary
A thromboembolic removal system for treating ischemic stroke, including a guide and occlusion catheter, a delivery and aspiration catheter, an aspiration pump, a thromboembolic receiver, and a thromboembolic separator.