Aortic Embolic Filter with Catheter Engaging Portion
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Solution Overview
Problem
Current embolic protection devices fail to effectively capture and prevent emboli from entering critical vasculature during medical procedures, particularly in the aorta, and often require additional access sites for deployment and radio-opaque contrast delivery, limiting their effectiveness and increasing the risk of emboli lodging in downstream organs.
Innovation Solution
An embolic filter device with an expandable frame member and membrane, designed for placement in the aorta to capture emboli, which includes a radial support member connected to longitudinal struts and an engaging portion to securely mate with an endovascular catheter, allowing for deployment in the ascending aorta to protect all three aortic branch vessels and the descending aorta, while also enabling radio-opaque contrast delivery through a multi-lumen delivery catheter without additional access sites.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If an embolic filter device is deployed in the aorta to capture emboli, then embolic protection is improved, but the device complexity increases due to the need for expandable frame members, membranes, and engaging portions
Solution Approach 1:
The embolic filter device is nested within the delivery catheter during delivery, with the expandable frame member and membrane contained inside the catheter body. The engaging portion is nested within the delivery system, allowing the entire device to be delivered through a single access site without requiring additional catheters or access points.
Solution Approach 2:
The delivery catheter serves multiple functions: it delivers the embolic filter device, provides radio-opaque contrast delivery, and enables deployment of the engaging portion. This multi-functionality reduces the need for separate devices and access sites, thereby reducing overall system complexity while maintaining effective embolic protection.
2Adaptability or versatility
If additional access sites are used for device deployment and contrast delivery, then device functionality is improved, but the risk of emboli lodging in downstream organs increases
Solution Approach 1:
The delivery catheter combines multiple functions into a single device: it serves as both the deployment mechanism for the embolic filter device and the conduit for radio-opaque contrast delivery. This merging eliminates the need for additional access sites, thereby reducing the risk of emboli introduction while maintaining full device functionality.
Solution Approach 2:
The delivery catheter acts as an intermediary that allows the embolic filter device to be deployed and contrast to be delivered through a single, controlled access site. This intermediary structure enables safe delivery and deployment while minimizing the risk of emboli lodging in downstream organs by avoiding multiple puncture sites.
3Reliability
If the membrane covers substantially all of the cross-sectional area of the blood vessel, then embolic capture effectiveness is improved, but the device complexity and difficulty of catheter maneuverability increase
Solution Approach 1:
The membrane is constructed as a flexible thin film that can conform to the blood vessel wall when deployed. This flexibility allows the membrane to cover substantially all of the cross-sectional area of the vessel for effective embolic capture, while the thin-film construction minimizes interference with blood flow and catheter maneuverability.
Solution Approach 2:
The membrane transitions from a compressed state during delivery to an expanded state upon deployment, dynamically adapting to cover the cross-sectional area of the blood vessel. This dynamic behavior allows the device to achieve high embolic capture effectiveness while maintaining compatibility with the delivery system and minimizing interference with catheter manipulation.
4Reliability
If the engaging portion sealingly mates with the endovascular catheter, then embolic protection is improved, but the ease of operation decreases due to constraints on catheter adjustment and maneuverability
Solution Approach 1:
The engaging portion provides a dynamic, reversible connection to the endovascular catheter that allows for sealing engagement during the procedure while permitting adjustment and maneuverability. The engaging structure can be selectively engaged and disengaged, maintaining embolic protection when needed while allowing operational flexibility during catheter manipulation.
Data Source
AI summary
One aspect of the present disclosure relates to an embolic filter device configured for placement in a blood vessel to capture emboli during a medical procedure. The embolic filter device can include an expandable frame member and a membrane. The expandable frame member can include a radial support member operably connected to first and second longitudinal struts, and an engaging portion extending between the first and second longitudinal struts. The engaging portion can be shaped and configured to temporarily receive, and sealingly mate with, a portion of an endovascular catheter during the medical procedure. The membrane can be securely connected to the frame member and define a collection chamber for captured emboli. The membrane can be configured to cover substantially all of the cross-sectional area of the blood vessel when the embolic filter device is deployed in the blood vessel.