Aortic Embolic Deflector for Stroke Prevention
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Solution Overview
Problem
Current endovascular procedures face challenges in protecting the cerebral vasculature from emboli, as existing devices are cumbersome, difficult to place, and pose a risk of stroke due to manipulation of carotid arteries during filter placement, with limited applicability and effectiveness in maintaining blood flow during procedures.
Innovation Solution
The Embrella device is designed to deploy via a brachial or radial approach, self-aligning in the aorta to cover the ostia of the brachiocephalic and left common carotid arteries, providing embolic protection with a low profile that allows blood flow while deflecting emboli greater than 100 microns, and can be easily placed and retrieved using standard Seldinger technique.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If filters are placed in carotid arteries for cerebral protection, then embolic protection is improved, but stroke risk increases due to manipulation of carotid vessels during filter placement
Solution Approach 1:
The patent introduces an intermediary device (the filter) that is placed in the aorta rather than directly in the carotid artery. This intermediary placement allows the filter to protect the cerebral vasculature from emboli while avoiding direct manipulation of the carotid arteries during filter placement, thereby reducing stroke risk while maintaining embolic protection
Solution Approach 2:
The filter is deployed in the aorta before the embolic procedure begins, establishing protection in advance. This preliminary placement allows the cerebral vasculature to be protected from the start of the procedure without requiring manipulation of the carotid arteries during the procedure itself
2Reliability
If filters are used for cerebral protection, then embolic protection is improved, but device complexity and difficulty of placement increase
Solution Approach 1:
The filter device is designed to be universally applicable for cerebral protection during various endovascular procedures. It can be placed through standard femoral or brachial approaches and is compatible with different procedural configurations, reducing placement complexity while maintaining effective embolic protection across multiple applications
3Reliability
If filters are placed in carotid arteries, then cerebral protection is improved, but time and skill requirements increase
Solution Approach 1:
By using the aorta as an intermediary location for filter placement, the procedure avoids the time-consuming task of selective carotid cannulation. The filter can be deployed through standard femoral or brachial approaches into the aorta, significantly reducing placement time and skill requirements while maintaining effective cerebral protection
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 Embrella device effectively shields the carotid arteries from embolic debris, reducing the risk of stroke by maintaining cerebral blood flow and allowing for safe passage of catheters and sheaths during procedures, with a low risk of interaction and minimal risk of emboli entry into the cerebral circulation.
Implementation Method 1
The device includes a porous membrane which allows flow but deflects emboli greater than 100 microns
Data Source
AI summary
There is disclosed a porous emboli deflector for preventing cerebral emboli while maintaining cerebral blood flow during an endovascular or open surgical procedure. The device prevents the entrance of emboli of a size able to cause stroke (greater than 100 microns in the preferred embodiment) from entering either the right or left carotid arteries by deflecting emboli downstream in the blood flow. The device can be placed prior to any manipulation of the heart or aorta allowing maximal protection of the brain during the index procedure. The device has a low profile within the aorta which allows sheaths, catheters, or wires used in the index procedure to pass. Also disclosed are methods for insertion and removal of the device.