Distal Protection Filters with Nested Sheaths for Carotid Embolic Capture
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Solution Overview
Problem
Current medical procedures lack effective solutions for providing embolic protection to the right and left common carotid arteries during procedures like aortic valve replacement, which can lead to complications such as stroke due to embolic debris entering the bloodstream.
Innovation Solution
A system comprising two self-expanding distal protection filters with adjustable placement and independent locking mechanisms, deployed in the brachiocephalic trunk and left common carotid artery, to capture embolic debris, along with a method for deploying and retrieving these filters to minimize interference with the procedure.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a single distal protection filter is used, then the device complexity is low, but the embolic protection coverage is insufficient for multiple carotid arteries
Solution Approach 1:
The system divides the embolic protection function into multiple independent filters (first distal protection filter for right common carotid artery, second distal protection filter for left common carotid artery). Each filter independently protects a specific arterial branch, providing comprehensive coverage while maintaining manageable complexity through modular design
Solution Approach 2:
The first and second sheaths are disposed within an outer sheath, creating a nested configuration. The distal ends of the sheaths extend beyond the outer sheath to position the filters at appropriate locations in the carotid arteries. This nesting approach allows multiple filters to be delivered through a single access point while maintaining independent functionality
2Reliability
If the filters are positioned to maximize embolic protection, then the protection effectiveness is improved, but the interference with the medical procedure increases
Solution Approach 1:
The system allows dynamic adjustment of filter positions through independent sheath manipulation. The sheaths can be advanced or retracted to optimize filter placement in the carotid arteries while minimizing obstruction to the medical procedure. The filters can be positioned at different depths depending on procedural needs, providing flexibility to balance protection effectiveness with procedural accessibility
Solution Approach 2:
The distal protection filters are deployed before the medical procedure (aortic valve replacement) begins. This preliminary placement ensures that any embolic debris generated during the procedure is captured from the outset, preventing stroke while allowing the procedure to proceed without interruption. The filters remain in place throughout the procedure, providing continuous protection
3Reliability
If the filters are made to capture all embolic debris, then the protection reliability is improved, but the blood flow restriction increases
Solution Approach 1:
The filter elements are designed with spatially varying pore sizes and distributions. Different regions of each filter have different filtration characteristics optimized for local flow conditions and embolic debris sizes. This allows the filters to capture embolic debris effectively while maintaining adequate blood flow through regions with larger pores, balancing protection reliability with flow preservation
Solution Approach 2:
The filters utilize porous filter elements with controlled pore sizes and distributions. The porous structure allows blood cells and plasma to pass through while trapping embolic debris particles. The pore size is optimized to capture potentially harmful emboli while permitting adequate blood flow, reducing the harmful effect of flow restriction while maintaining protection reliability
Data Source
Figure 1A~1B
Figure 2A~2C
Figure 3A~3B
AI summary
Embodiments of the invention relate generally to devices and methods for providing filtration of debris within a body lumen. More particularly, embodiments of the invention related to devices and methods for providing distal protection to a medical procedure by filtration of debris generated by the medical procedure using filters having a frame with a slidable crossover point.