Catheter Filter With Sealing Arm for Embolic Protection
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Solution Overview
Problem
Existing medical procedures, such as TAVR, face challenges with the dislodgement of particles during device deployment, leading to emboli that can cause strokes by blocking or occluding vessels, and existing filters do not provide effective embolic protection.
Innovation Solution
A catheter-based filter apparatus with a frame and extension arm that expands to conform to a tubular organ's inner sidewall, sealing the filter to trap particles and retract into the catheter, utilizing a dynamic, double-edge sealing mechanism to protect against emboli during cardiac output cycles.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a filter apparatus is deployed to capture embolic debris, then embolic protection is improved, but the device complexity increases due to the frame, extension arm, and sealing mechanism
Solution Approach 1:
The filter apparatus is divided into distinct functional segments: a frame structure, an extension arm with extension element, a filter component, and sealing elements. This segmentation allows each component to perform its specific function independently while simplifying the overall design and assembly of the device.
Solution Approach 2:
The filter apparatus is designed to be nested within a delivery catheter in a compressed state during delivery, then expanded at the target site. The extension element can be nested within the extension arm, and the filter can be nested within the frame structure, reducing the delivery profile while maintaining full functionality at deployment.
2Reliability
If the filter apparatus expands to conform to the aortic arch, then the sealing effectiveness is improved, but the force required to maintain the seal increases during cardiac output cycles
Solution Approach 1:
The extension arm is designed with dynamic characteristics that allow it to flex and adapt to the pulsating forces of cardiac output cycles. The extension element can extend and retract in response to pressure changes, maintaining the seal without requiring excessive force. The frame structure is also designed to conform dynamically to the aortic arch geometry during the cardiac cycle.
Solution Approach 2:
The apparatus utilizes changes in pressure parameters during the cardiac cycle to its advantage. During diastole, the pressure differential helps maintain the seal, while during systole, the extension element can extend to compensate for increased forces. The sealing force requirement is modulated by the natural pressure variations in the aortic arch.
3Stability of the object's composition
If the extension arm engages with the inner sidewall to apply sealing force, then the seal stability is improved, but the device may cause damage to the vessel wall
Solution Approach 1:
The sealing interface utilizes flexible elements that can conform to the vessel wall surface without requiring excessive force. The extension element and frame contact surfaces are designed as flexible or compliant structures that adapt to the vessel wall geometry, distributing the sealing force over a larger area and reducing peak stresses that could cause damage.
Solution Approach 2:
The sealing elements are designed to replicate or conform to the natural geometry of the aortic arch and vessel wall. By copying the anatomical contours, the apparatus achieves stable sealing through geometric compatibility rather than relying on high forces, thereby minimizing the risk of vessel wall damage.
4Ease of operation
If the filter apparatus is made retractable for removal, then the ease of operation is improved, but the reliability of embolic protection may be compromised during retraction
Solution Approach 1:
The apparatus is designed to capture and trap embolic debris within the filter structure before retraction begins. The frame and extension arm are configured to maintain the seal and contain captured particles during the retraction process. The delivery catheter and retrieval system are prepared in advance to ensure smooth retraction without dislodging captured emboli.
Data Source
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AI summary
Aspects of the present disclosure are directed toward catheter-based apparatuses, such as componentry utilized with or as part of catheters, or as catheters or catheter assemblies. As may be implemented in accordance with one or more embodiments, a method and/or apparatus involves a filter having a frame that forms a perimeter of the filter and separates opposing surfaces thereof. An articulated arm is connected to the frame and configured therewith to, when deployed within a tubular organ, engage with opposing inner sidewall portions of the tubular organ and to utilize the inner sidewall portions to seal filter to the inner sidewall by applying force to the frame.