Integrated Embolic Filter Catheter for Single-Access Protection
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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 multiple access sites, which can lead to patient injury and increased procedural complexity.
Innovation Solution
Integration of an embolic protection system with catheters or access sheaths, featuring a porous mesh filter that self-expands to capture emboli, allowing for reduced procedural steps and access sites, with features like stent-like support scaffolds and antithrombogenic coatings to prevent emboli while minimizing the overall catheter diameter.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If separate embolic protection devices are used with multiple access sites, then embolic protection is provided, but procedural complexity increases and patient injury risk increases
Solution Approach 1:
The patent combines the embolic protection device with the catheter by integrating a filter assembly onto the catheter shaft. The filter can be positioned distally on the catheter and secured with a retention member, allowing the catheter itself to serve dual purposes: both as the intervention tool and as the embolic protection device. This eliminates the need for separate access sites and reduces procedural steps while maintaining effective embolic protection.
2Reliability
If separate embolic protection devices are used with multiple access sites, then embolic protection is provided, but the number of access sites increases
Solution Approach 1:
By integrating the filter assembly directly onto the catheter, the invention allows a single access site to serve both the intervention catheter and the embolic protection function. The filter is deployed at the target location within the same vascular access, eliminating the need for additional puncture sites and associated risks of patient injury.
3Device complexity
If an embolic protection device is integrated with the catheter, then procedural complexity is reduced, but the catheter diameter may increase
Solution Approach 1:
The filter assembly is designed to collapse into a compact configuration that nests within or alongside the catheter shaft during delivery. The filter elements can be folded or compressed into a low-profile state that fits within the catheter's delivery profile, allowing integration without significantly increasing the catheter's overall diameter or preventing passage through standard vascular access.
Solution Approach 2:
The filter assembly transitions from a compressed delivery configuration to an expanded functional configuration at the target site. During delivery, the filter remains compact to maintain a small profile; once positioned, it expands to provide effective embolic protection. This dynamic transformation allows the device to achieve both small delivery profile and large functional size.
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 approach minimizes procedural complexity, reduces the risk of embolic events, and enhances the safety and efficiency of catheter-based interventions by providing effective embolic protection without increasing the catheter's profile or requiring additional access points.
Implementation Method 1
The filter comprises a port for the passage of the shaft therethrough and a porous mesh material. The porous mesh material defines a collection chamber for captured emboli.
Implementation Method 2
A resilient seal may be positioned within the catheter port for forming a seal around the shaft passing through the filter port.
Data Source
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.