Nested Clot Engagement and Capture Device
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Solution Overview
Problem
Existing clot removal devices risk dislodging clot fragments during the removal process, potentially causing further damage and trauma, as they may disrupt the clot before deployment or deploy in unintended areas of the vasculature.
Innovation Solution
A clot removal device featuring an expandable clot engagement element and capture element, with a sheath that compresses and surrounds them, allowing for controlled expansion within the blood vessel to securely grasp and remove clots without breaking them, utilizing a coil or mesh-like structure and a locking mechanism to stabilize the clot during removal.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If a catheter with balloon is passed through the clot and the balloon is inflated to remove the clot, then the clot can be removed from the blood vessel, but the clot may be disrupted causing pieces to break away and travel through the vasculature causing traumatic damage
Solution Approach 1:
The device performs preliminary engagement of the clot by the expandable engagement element before capture. The engagement element is positioned and secured to the clot first, then the capture element is deployed to contain the clot, preventing fragmentation during the removal process
Solution Approach 2:
The device uses a nested structure where the engagement element is positioned within the capture element. The engagement element directly contacts and secures the clot, while the capture element surrounds and contains the engagement element-clot assembly, providing dual protection against clot disruption
2Ease of operation
If a spiral section is used to cut into the clot and grasp an inner portion, then the clot can be grasped for removal, but the pre-deployment activity can disrupt the clot causing pieces to break away
Solution Approach 1:
The expandable engagement element is designed to engage the clot in a controlled manner upon deployment, rather than requiring pre-deployment manipulation. The element expands to contact and secure the clot gently, avoiding disruption that would occur with cutting or grasping maneuvers performed before final positioning
Solution Approach 2:
The engagement element transitions from a compressed delivery state to an expanded engaged state, changing its physical parameters to achieve clot contact. This controlled parameter change allows the element to adapt to the clot size and shape without requiring forceful manipulation that could cause fragmentation
3Reliability
If there is increased risk of deploying a device in uninvolved distal territory, then the device may cause traumatic damage, but restricting device deployment reduces the ability to reach and remove clots effectively
Solution Approach 1:
The device incorporates visual feedback mechanisms including radiopaque markers and imaging capabilities that allow the operator to confirm device position and engagement status before proceeding with clot removal. This feedback ensures the device is correctly positioned in the target vessel and has successfully engaged the clot, preventing deployment in uninvolved territory while maintaining effective clot removal capability
Data Source
AI summary
A clot removal device and method for removing a dot from a blood vessel may include an expandable clot engagement element, an expandable dot capture element, and a sheath surrounding and compressing the capture element and the engagement element. The sheath may be removable to thereby enable the capture element to expand in a blood vessel in which the sheath is deployed, and to enable the engagement element to expand within the capture element.