Funnel Sheath Deployment for Adherent Clot Extraction
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Solution Overview
Problem
Existing thrombectomy devices face challenges in safely and effectively removing large, adherent blood clots from blood vessels, particularly in the brain or other vital organs, due to limitations in deployment mechanisms and clot extraction methods.
Innovation Solution
A vascular introducer set with a dilator featuring a rotation mechanism for deploying a self-expanding funnel and an extractor device with a control handle, which includes a 3-shaft assembly, to facilitate the safe and effective deployment and extraction of clots, utilizing a coring element and mesh for clot removal.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a conventional funnel deployment mechanism is used, then the funnel can be deployed, but the deployment is not controlled and safe, especially in vascular systems
Solution Approach 1:
The funnel is designed with dynamic deployability through a rotation mechanism that allows controlled transition from a constrained delivered state to an expanded functional state. The funnel can be rotated to a deployed position where it expands to engage with the vessel wall, providing dynamic adaptation to vascular anatomy while maintaining safe, controlled deployment.
Solution Approach 2:
The funnel is pre-constrained within the dilator during delivery to ensure safe insertion into the vascular system. The constraint mechanism is designed to release the funnel at the target location through rotation, allowing preliminary positioning followed by controlled deployment only when needed.
2Length of moving object
If the funnel is made longer to increase treatment length, then more clot can be engaged, but the funnel becomes harder to constrain and deploy safely
Solution Approach 1:
The funnel is segmented into multiple expandable sections that can be constrained individually within the dilator. This segmentation allows the funnel to achieve sufficient length for treating long clots while maintaining the ability to constrain each segment separately, preventing uncontrolled expansion during delivery.
Solution Approach 2:
The rotation mechanism provides dynamic control over the funnel's expansion state. The funnel can be rotated to a constrained position during delivery and then rotated to an expanded position at the target location, allowing the system to adapt the effective length of the funnel based on the clot size and location while maintaining safety.
3Productivity
If a single-shot thrombectomy device is used, then the procedure is simple, but large, adherent clots cannot be effectively removed
Solution Approach 1:
The thrombectomy device incorporates dynamic elements including a rotatable funnel that can transition between constrained and expanded states, and a coring element that can be advanced and retracted. These dynamic components enable the device to adapt to different clot characteristics and vessel anatomy, improving productivity while managing complexity through controlled mechanical movements.
Solution Approach 2:
The device is divided into functional segments: the introducer sheath, the rotatable funnel, the coring element, and the mesh element. Each segment performs a specific function in the clot removal process, allowing complex clot extraction to be achieved through coordinated action of simpler, modular components rather than a single complex structure.
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 enables safe and effective removal of high-volume, long-length mixed clots with a wall adherent component, such as those causing peripheral venous DVT, by ensuring controlled deployment and efficient clot removal.
Implementation Method 1
rotating a first component of the rotation mechanism to cause the cap to advance away from the introducer sheath
Implementation Method 2
a self-expanding funnel coupled to the tube... the self-expanding funnel is maintained in a constrained state by the cap... the self-expanding funnel is unconstrained and able to transition to an expanded state
Data Source
AI summary
Systems and apparatuses are provided for clot extraction. In a first aspect, a system includes a first shaft, a second shaft, a third shaft, a coring element including a blade, and a mesh. The coring element has a first end and a second end. The first end of the coring element is coupled to the first shaft and the second end of the coring element is coupled to the second shaft. The mesh includes an open end and a second end. The open end of the mesh is coupled to a proximal portion of the coring element and the second end of the mesh is coupled to the third shaft through a tip structure. Other aspects and features are also claimed and described.


