Embolic Protection Filter With Flow-Activated Vessel Sealing
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Solution Overview
Problem
Current vascular protection devices during procedures like TAVR fail to form a secure seal with the vessel wall, allowing emboli to pass and pose a risk of stroke, and captured clots can dislodge during device removal.
Innovation Solution
A filter device with a flow-activated sealing membrane that expands against the vessel wall, combined with a catheter system for secure capture and removal of emboli, ensuring a tight seal and preventing emboli migration.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Object-affected harmful factors
If conventional deflector devices are used to redirect emboli away from critical vessels, then emboli can be redirected from the brain, but the devices do not form an adequate seal against the vessel wall allowing emboli to pass through
Solution Approach 1:
The device divides the protection mechanism into two functional segments: a deflector portion that redirects emboli away from critical vessels, and a separate seal portion that forms an adequate seal against the vessel wall. This segmentation allows each component to optimize its specific function without compromising the other.
Solution Approach 2:
The device merges the deflector function and seal function into a single integrated structure that performs both functions simultaneously. The deflector portion and seal portion work together as a unified system to both redirect emboli and prevent passage through the device-vessel interface.
2Object-affected harmful factors
If conventional capture devices are used to trap emboli, then emboli can be captured, but the devices do not adequately fit within the anatomy in at least 10% of cases creating risk of emboli passing
Solution Approach 1:
The seal portion of the device is designed to be dynamically adaptable to different anatomical configurations. The seal can adjust its shape and position to accommodate variations in vessel anatomy, ensuring adequate sealing across diverse patient geometries rather than relying on a fixed rigid structure.
Solution Approach 2:
The device allows for parameter changes in the seal portion to optimize anatomical fit. This may include adjustments in seal diameter, length, or material properties to match the specific anatomical parameters of each patient, thereby improving the fit in cases where conventional fixed-parameter devices fail.
3Object-affected harmful factors
If filter devices are used to prevent emboli passage, then emboli can be filtered, but the devices allow thrombi to pass by if the seal against the vessel wall is suboptimal causing cerebral ischemic strokes
Solution Approach 1:
The seal portion is designed to establish preliminary contact with the vessel wall before the filter function is activated. This preliminary sealing action ensures that the sealing interface is properly positioned and engaged before emboli are captured or redirected, preventing thrombi from passing through suboptimal seals.
Solution Approach 2:
The seal portion acts as an intermediary element between the filter device and the vessel wall. This intermediary seal ensures optimal contact and sealing, preventing direct passage of thrombi through gaps between the rigid filter structure and the vessel wall.
4Object-affected harmful factors
If open-ended filter devices are used to capture emboli, then emboli can be collected, but the open ends allow captured clots to potentially dislodge and travel back into the bloodstream
Solution Approach 1:
The open end of the filter device is closed by extracting or deploying a closing mechanism that seals the distal end. This extraction action converts the open-ended structure into a closed containment system, preventing captured clots from dislodging and traveling back into the bloodstream while maintaining the collection function.
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 effectively traps emboli, reducing the risk of stroke by ensuring a secure seal and preventing emboli from escaping during and after the procedure.
Implementation Method 1
a sealing membrane circumferentially located on the distal portion that deflects from the filter body as a result of blood flow against the sealing membrane, wherein the deflection of the sealing member permits creation of a seal against a wall of the vessel
Data Source
AI summary
Devices, systems and methods for filtering embolic particles that may be generated from a medical procedure including protection of the major branching vessels from the aorta, and catches and filters emboli that may be generated during the TAVR procedure. The filter devices disclosed herein form an improved seal against the vessel wall that is activated by flowing blood. Devices described herein also allow for the closing of the ends of the filter device after capture of emboli, providing further security against accidental loss of emboli post capture.