Integrated embolic protection devices
Solution Overview
Problem
Current embolic protection devices for preventing cerebral embolism during catheter-based procedures are cumbersome, require multiple components and steps, and often necessitate additional access sites, which can increase the risk of injury and procedural complexity.
Innovation Solution
Integration of an embolic protection device with a catheter or access sheath, featuring a porous mesh filter with a cylindrical and conical structure that self-expands to deploy within a blood vessel, allowing for reduced procedural steps and access sites, while maintaining emboli capture efficacy.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a separate embolic protection device is used, then emboli capture efficacy is improved, but device complexity and procedural steps increase
Solution Approach 1:
The patent combines the embolic protection filter with the catheter shaft by providing a catheter with an integrated filter assembly. The filter is positioned at the distal end of the catheter shaft and can be deployed independently while remaining structurally integrated with the catheter, thereby maintaining emboli capture efficacy while reducing overall device complexity and the number of separate components.
Solution Approach 2:
The catheter is designed to serve multiple functions: it acts as both the delivery catheter for interventional procedures and the embolic protection device. The filter assembly integrated on the catheter shaft allows the same device to perform both diagnostic/therapeutic functions and emboli capture, reducing the need for separate protection devices and simplifying the procedural workflow.
2Reliability
If a separate embolic protection device is used, then emboli capture efficacy is improved, but the number of access sites required increases
Solution Approach 1:
By integrating the embolic protection filter with the catheter shaft, the invention allows both the interventional catheter and the protection device to be introduced through the same access site. This eliminates the need for separate vascular access procedures, reducing the number of puncture sites and associated risks while maintaining effective emboli capture.
3Reliability
If the catheter diameter is increased to accommodate an integrated filter, then embolic protection capability is improved, but catheter deliverability worsens
Solution Approach 1:
The filter assembly is designed to be collapsible during delivery and self-expandable upon deployment. The catheter with integrated filter can be navigated through vessels in a compressed state, and the filter automatically expands to its functional configuration when deployed at the target site, thereby maintaining small delivery profile while achieving full embolic protection capability.
Solution Approach 2:
The filter assembly is nested within or integrated along the catheter shaft in a compact configuration during delivery. The filter can be positioned within the catheter lumen or attached to the outer surface in a collapsed state, allowing the entire assembly to pass through narrow vascular pathways without increasing the effective delivery diameter.
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
This integrated solution minimizes extra procedural steps and access sites, ensuring effective emboli capture without increasing the catheter diameter, thus enhancing the safety and efficiency of catheter-based interventional procedures.
Implementation Method 1
The filter has a collapsed configuration and a deployed configuration. When in the deployed configuration, an outer periphery of the filter contacts a blood vessel wall to direct blood flow and potential emboli into the collection chamber.
Data Source
Figure 1A~1C
Figure 1D~1E
Figure 2A
AI summary
Embolic protection elements are integrated with a catheter or access sheath for any catheter. A catheter with an integrated embolic protection element comprises a catheter shaft, an embolic filter slidably mounted on a distal portion of the shaft, a proximal stop for limiting the proximal movement of the embolic filter, and a distal stop for limiting the distal movement of the embolic filter. The filter comprises a porous mesh material defining a collection chamber for captured emboli and has a collapsed and a deployed configuration. The filter may be collapsed by an access sheath used with the catheter. An access sheath may comprise a tubular main body and an embolic filter mounted on the distal portion of the tubular main body. The embolic filter may evert into the central lumen of the sheath or may be constrained on the exterior of the sheath with a larger diameter outer tube.