Multi-Element Thrombectomy Retrieval for Complete Clot Capture
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Solution Overview
Problem
Existing devices for treating ischemic stroke by removing blood clots in blood vessels have low rates of complete recanalization and may fragment the clot, requiring multiple passes and potentially causing further obstruction.
Innovation Solution
A device with a central wire and multiple engaging elements, including a distal, middle, and proximal engaging element, configured to expand upon unsheathing from a microcatheter, inhibiting re-sheathing and allowing for complete clot capture, featuring a stopper to prevent retraction and a linking structure that spaces the elements apart for efficient occlusion removal.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If stent retriever devices or suction thrombectomy catheters are used for thrombectomy, then some clot removal is achieved, but complete recanalization rates are low and multiple passes are required
Solution Approach 1:
The device divides the clot engagement function into multiple segments: a distal engagement element for initial clot capture, and one or more proximal engagement elements that can be advanced to engage additional clot portions. This segmentation allows the device to capture the entire clot in a single pass rather than requiring multiple passes, directly improving productivity while reducing time loss.
Solution Approach 2:
The device performs preliminary engagement of the clot with the distal element before attempting full retrieval. This staged approach allows the operator to secure the clot initially, then advance additional elements to ensure complete capture before withdrawal, preventing clot fragmentation and ensuring complete recanalization in one procedure.
2Reliability
If existing thrombectomy devices are used, then some vessels are reopened, but complete recanalization is not always achieved and vessels may remain partially occluded
Solution Approach 1:
The device incorporates dynamically adjustable engagement elements where the proximal elements can be advanced or retracted relative to the distal element. This dynamic configuration allows the operator to adapt the device to different clot sizes and positions, ensuring complete engagement and reliable recanalization while maintaining high productivity through a single-pass procedure.
Solution Approach 2:
The device changes the engagement parameter by introducing multiple engagement elements at different positions along the catheter. This allows adjustment of the engagement zone to match the clot dimensions, improving both the reliability of vessel reopening and the productivity of achieving complete recanalization in one procedure.
3Productivity
If thrombectomy devices are passed multiple times into the intracranial circulation, then clot removal may be achieved, but the risk of clot fragmentation and distal embolization increases
Solution Approach 1:
The segmented design with multiple engagement elements allows the entire clot to be captured in a single pass, eliminating the need for repeated catheter manipulations that cause fragmentation. The distal element secures the clot while proximal elements engage additional portions, ensuring complete capture without fragmentation.
Solution Approach 2:
The device performs preliminary engagement with the distal element to secure the clot before advancing proximal elements. This preliminary action prevents clot displacement or fragmentation during the engagement process, and the multi-element design ensures complete capture in one procedure, eliminating the harmful effects of multiple passes.
4Reliability
If engaging elements are designed to expand upon unsheathing, then clot capture is improved, but re-sheathing becomes inhibited
Solution Approach 1:
The engagement elements are designed to be dynamically controllable, allowing the operator to maintain them in an expanded state for stable clot capture, then selectively reduce their profile for retrieval. The proximal elements can be advanced or retracted to adjust the engagement configuration, providing both stable capture and ease of retrieval when needed.
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 achieves high rates of complete recanalization with rapid clot capture and removal, minimizing vessel damage and reducing the risk of clot fragmentation.
Implementation Method 1
a proximal end of the proximal engaging element comprises a stopper configured to expand radially upon unsheathing the proximal engaging element from the microcatheter
Implementation Method 2
The stopper may comprise loops configured to bend radially outward upon unsheathing the engaging element from the microcatheter
Implementation Method 3
Alternatively the stopper may comprise a spiral spring wire configured to expand radially outward upon unsheathing the engaging element from the microcatheter
Data Source
Figure 1A~1B
Figure 2A~2C
Figure 3
AI summary
Devices and methods for increasing or restoring a flow in a body lumen. The devices and the methods may treat conditions like stroke by removing a clot from a blood vessel and/or reopen the vessel. The device may include a plurality of engaging elements, a central wire, and proximal control element. The device may include a linking structure between engaging elements. The linking structure may include segments configured to respond differently upon the application of longitudinal loads. The positions of the engaging elements and the distance therebetween can be adjusted simultaneously or sequentially to promote the engagement of the clot or occlusion. The device may include be configured to inhibit or prevent the proximal engaging element from being pulled back into a microcatheter when pulling the central wire to pull the distal engaging element proximally and/or during retraction of the device holding a clot.