Helical Venous Clot Retrieval for Chronic Fibrin Removal
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Solution Overview
Problem
Current therapies for deep vein thrombosis (DVT) and pulmonary embolism (PE) are inefficient in removing chronic fibrin and often cause vessel trauma, re-stenosis, and require prolonged hospital stays, with existing devices being complex, costly, and ineffective against chronic scar tissue.
Innovation Solution
A device comprising a core member, an inner member, and a helical outer member with a flexible material extending between them, configured to engage and remove clots via a low-profile delivery and expanded deployment, allowing for continuous hemostasis and minimal vessel trauma.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If thrombolytics are introduced to disintegrate the clot, then clot removal is achieved, but treatment time is prolonged and hemorrhaging risk increases
Solution Approach 1:
The patent replaces chemical thrombolytic systems with a mechanical thrombectomy device that physically removes clots through a helical screw mechanism. This mechanical approach eliminates the prolonged treatment time and hemorrhaging risks associated with thrombolytics while achieving effective clot removal.
Solution Approach 2:
The device extracts the clot from the vessel lumen as a discrete entity rather than dissolving it in place. The helical outer member engages the clot and mechanically pulls it out through the core member, achieving rapid removal without the time-consuming dissolution process of thrombolytics.
2Reliability
If conventional catheter-based thrombectomy devices are used, then clot removal is achieved, but device complexity and manufacturing cost increase
Solution Approach 1:
The device is divided into simple functional segments: a core member for delivery and retrieval, and a helical outer member for clot engagement. This segmentation creates a less complex device compared to conventional catheter-based systems while maintaining effective clot removal capability.
Solution Approach 2:
The helical outer member is designed as a flexible component that can be compressed for delivery and expanded for clot engagement. This flexibility simplifies the device structure compared to rigid conventional systems while enabling effective clot capture and removal.
3Productivity
If mechanical clot destruction is performed, then clot removal is achieved, but vessel trauma and re-stenosis risk increase
Solution Approach 1:
The device extracts the clot intact from the vessel rather than destroying it mechanically. The helical outer member engages and pulls the clot out through the core member, avoiding the vessel trauma associated with mechanical destruction methods while maintaining high removal efficiency.
Solution Approach 2:
The flexible material extending between the inner and outer members acts as an intermediary that engages the clot gently without direct mechanical destruction. This mediator allows clot removal while minimizing contact stress on the vessel wall, reducing trauma and re-stenosis risk.
4Reliability
If highly complex thrombectomy devices are used, then clot removal capability is improved, but ease of operation and navigation difficulty worsen
Solution Approach 1:
The helical outer member is nested within the core member in a compressed configuration for easy delivery and navigation. Upon deployment, the outer member expands to engage the clot. This nesting principle simplifies navigation through the vasculature while maintaining effective clot removal capability.
Solution Approach 2:
The device transitions dynamically from a compressed low-profile configuration during navigation to an expanded configuration during clot engagement. This dynamic transformation improves ease of navigation while maintaining clot removal effectiveness, eliminating the need for complex navigation procedures.
Data Source
AI summary
Systems and methods are provided for removal of clot material from a treatment site in a blood vessel, particularly in venous vasculature. A treatment device can include a core member having a distal portion and an inner coil surrounding the distal portion of the core member. A helical outer member surrounds at least a portion of the inner coil, and a sheet of flexible material extends between the inner coil and the helical outer member, such that the sheet extends helically around the inner coil to provide a surface for clot engagement at the treatment site.