Adjustable Engaging Elements for Intravascular Thromboembolectomy
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Solution Overview
Problem
Current devices for treating ischemic strokes, such as the Merci thrombectomy device, Penumbra suction thrombectomy catheter, and Solitaire thrombectomy device, often fail to achieve complete recanalization, may fragment clots, and require multiple passes to reopen blood vessels, leading to incomplete clot removal and delayed restoration of blood flow.
Innovation Solution
A microcatheter-based device with adjustable distal and proximal engaging elements, comprising a central wire, tubing compartment, and expandable stent-like structures, allows for precise engagement and removal of occlusions by adjusting the distance between the elements to capture and remove clots efficiently.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If current thrombectomy devices (Merci, Penumbra, Solitaire) are used to treat ischemic stroke, then the procedure can be performed with existing approved technology, but complete recanalization is not achieved, clot fragmentation occurs, and multiple passes are required leading to delayed blood flow restoration
Solution Approach 1:
The device divides the clot capture function into two separate engaging elements (distal and proximal) that can independently engage different portions of the clot. This segmentation allows the device to capture the entire clot in one pass without fragmentation, eliminating the need for multiple passes and reducing treatment time while improving complete recanalization rates.
Solution Approach 2:
The distance between the distal and proximal engaging elements is adjustable, allowing dynamic adaptation to different clot sizes and positions. This dynamic configuration enables optimal clot capture in a single pass, improving reliability of complete recanalization while reducing the time loss associated with multiple adjustment passes.
2Ease of manufacture
If current thrombectomy devices are used, then the device structure is relatively simple and easy to manufacture, but clot fragmentation occurs and complete clot capture is not achieved
Solution Approach 1:
By dividing the engagement function into two separate elements that can be independently positioned and adjusted, the device captures the entire clot between these elements without applying excessive force that would cause fragmentation. The segmented structure maintains manufacturing simplicity while eliminating the harmful fragmentation effect.
Solution Approach 2:
The adjustable distance parameter between the two engaging elements allows optimization of the capture zone to match the actual clot dimensions. This parameter adjustment enables complete clot capture without over-compression or fragmentation, maintaining ease of manufacture while preventing harmful clot fragmentation.
3Ease of operation
If current thrombectomy devices require multiple passes to reopen vessels, then the device can be used with standard procedural protocols, but the treatment time is extended and blood flow restoration is delayed
Solution Approach 1:
The two engaging elements work together in a single coordinated action to capture and remove the entire clot, eliminating the need for multiple passes. This segmented design maintains ease of operation through intuitive control of two elements while dramatically improving productivity by restoring blood flow in one pass.
Solution Approach 2:
The dynamic adjustability of the distance between engaging elements allows optimization for different clinical scenarios, enabling complete clot capture in a single pass. This dynamic capability maintains procedural simplicity while accelerating blood flow restoration by eliminating repeated insertion and adjustment cycles.
Data Source
AI summary
A device and a method for increasing or restoring a flow in a body lumen are provided. The device and the method may treat conditions related to a stroke, such as an ischemic stroke, by removing an occlusion from a blood vessel and/or reopen a blood vessel. The device may comprise a tubing compartment, a central wire, and an engaging compartment. The engaging compartment may comprise a distal engaging element and a proximal engaging element. A clot or occlusion present in the body lumen such as an artery may be engaged in and/or between the distal and proximal engaging elements. Further, the positions of one or both of the engaging elements and the distance therebetween can be adjusted to ensure the engagement of the clot or occlusion.