Aortic Arch Embolic Protection Device
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Solution Overview
Problem
Current therapies for preventing cardio-embolic stroke, such as anticoagulation and mechanical isolation of the left atrial appendage, have limitations including the risk of bleeding complications and ongoing thrombosis with mechanical devices, and procedures like TAVR are associated with high stroke risk due to embolic events during and after the procedure.
Innovation Solution
An embolic protection device is implanted in the aortic arch with flow-modulating elements that deflect emboli away from the cranial circulation, allowing blood to flow through while preventing emboli from entering the brain, and can be used during and after procedures like TAVR to reduce stroke risk.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If anticoagulation therapy is used to prevent cardio-embolic stroke, then stroke prevention is improved, but bleeding risk increases
Solution Approach 1:
The device extracts and removes emboli from the blood stream before they can reach the brain, providing mechanical stroke prevention without requiring anticoagulation therapy. This eliminates the bleeding risk associated with pharmacological anticoagulation while maintaining stroke protection.
Solution Approach 2:
The embolic protection device acts as an intermediary barrier in the aortic arch that intercepts emboli. Instead of using chemical anticoagulants that increase bleeding risk, the device provides physical protection by deflecting emboli away from cranial circulation.
2Reliability
If mechanical isolation of left atrial appendage is performed, then thrombus formation is reduced, but device-related thrombosis risk persists
Solution Approach 1:
The device extracts emboli from the circulation before they can cause stroke, providing protection without requiring long-term anticoagulation. This avoids the device-related thrombosis risk that persists with mechanical left atrial appendage isolation devices.
3Reliability
If TAVR procedure is performed to treat aortic stenosis, then valve function is improved, but stroke risk increases due to embolic events
Solution Approach 1:
The embolic protection device is deployed before the TAVR procedure to prevent embolic events during valve replacement. By establishing protection in advance, the device captures emboli generated during catheter manipulation and valve deployment, preventing stroke while allowing the TAVR procedure to proceed.
Solution Approach 2:
The protection device serves as an intermediary barrier during TAVR that intercepts emboli generated by procedural trauma, balloon valvuloplasty, and valve deployment. This allows TAVR to be performed with reduced stroke risk.
4Reliability
If flow-modulating elements are added to deflect emboli, then stroke protection is improved, but device complexity increases
Solution Approach 1:
The flow-modulating elements are strategically positioned at specific locations within the aortic arch where emboli are most likely to be deflected away from cranial circulation. This localized approach provides effective stroke protection without requiring complex device structures throughout the entire implant.
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 embolic protection device effectively reduces the risk of stroke by deflecting emboli downstream, providing protection during and after procedures, and can be implanted chronically for long-term stroke prophylaxis in high-risk patients.
Implementation Method 1
The flow-modulating elements modulate blood flow such that emboli shift trajectory based on modulated blood flow streamlines
Implementation Method 2
An expandable and substantially cylindrical frame configured to expand to engage an inner wall of a blood vessel
Data Source
AI summary
An embolic protection device comprises an intravascular flow-interactive surface supported by an expandable, substantially cylindrical frame, wherein the frame is configured to expand and engage the luminal surface of the ascending aortic arch, wherein said frame defines a longitudinal channel generally parallel to predominant blood flow vectors, and wherein a flow-modulating element is configured to alter fluid dynamics in a manner that redirects the cranial trajectory of embolic particles originating from the heart through and beyond the longitudinal channel. The embolic protection device may also comprise a plurality of independent or interconnected flow-modulating elements serially spaced apart along the longitudinal axis of the primary vessel. The interstitial space between flow-modulating elements allows blood flow passage between one another in a direction generally perpendicular to the longitudinal channel. The open central channel allows interval passage and manipulation of transcatheter instruments while maintaining the integrity of radially positioned flow-modulating surfaces.