Multi-Lumen Catheter for Coronary Occlusion Treatment
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Solution Overview
Problem
Current treatment options for chronic total occlusions (CTOs) in vascular occlusions are challenging due to the risk of perforating the vessel wall and the lengthy procedure times, which can lead to physician fatigue and increased complications.
Innovation Solution
A device with multiple lumens for imaging, tissue ablation, inert gas delivery, and vacuum capabilities is used to create a pathway through a CTO without entering the subintimal space, reducing the risk of vessel wall perforation and shortening procedure times.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If traditional PCI procedures are used to treat CTOs by directing guide wire through the occluded region, then a passageway can be created through the blocked vessel, but the risk of inadvertently perforating the vessel wall increases significantly
Solution Approach 1:
The catheter is divided into multiple functional segments including a distal tip portion with imaging capability, a middle section with laser fiber, and proximal control sections. This segmentation allows each portion to perform its specific function (imaging, ablation, control) independently, enabling precise navigation through the CTO while visualizing the vessel wall to avoid perforation
Solution Approach 2:
The imaging fiber is advanced ahead of the laser fiber to预先 visualize the vessel wall and occlusion structure before the laser ablation begins. This preliminary imaging action allows the operator to plan the ablation path and avoid areas that could lead to vessel wall perforation
Solution Approach 3:
The imaging system provides real-time feedback about the catheter position relative to the vessel wall and occlusion. This feedback loop allows continuous adjustment of the ablation path to maintain safety margins from the vessel wall while effectively treating the CTO
2Productivity
If traditional CTO PCI procedures are performed with extreme concentration over prolonged time periods, then the procedure can be completed, but physician fatigue increases and procedure time extends up to three hours
Solution Approach 1:
The catheter system performs self-navigation and self-positioning through the CTO using integrated imaging and ablation capabilities. The imaging fiber automatically visualizes the path ahead, and the laser fiber follows to ablate the occlusion without requiring constant manual manipulation, reducing physician workload and procedure time
Solution Approach 2:
Traditional mechanical manipulation and visual estimation are replaced with optical imaging and controlled laser ablation. The imaging system provides real-time visualization of the occlusion and vessel wall, replacing the need for prolonged manual guidance and reducing procedure time
3Ease of operation
If guide wire or components are directed through the subintimal space in the vessel, then passage through the occlusion can be achieved, but the limited space available increases the difficulty and risk of the procedure
Solution Approach 1:
The catheter integrates multiple functions including imaging, laser ablation, and navigation into a single device. This multi-functionality eliminates the need for separate guide wires, catheters, and imaging devices, simplifying the overall procedure while maintaining the ability to navigate through the CTO
Solution Approach 2:
The imaging fiber acts as an intermediary between the operator and the occlusion site, providing real-time visualization of the path ahead. This intermediary allows the operator to navigate the laser fiber through the CTO with precision without direct mechanical manipulation, reducing procedural complexity
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
The device effectively reduces the risk of vessel wall perforation and shortens procedure times, making the treatment of CTOs safer and more efficient, and potentially increasing the number of physicians capable of performing these procedures.
Implementation Method 1
an imaging fiber configured to allow a user to visually inspect a blood vessel wall and occlusion material ahead of a focus of the laser fiber
Implementation Method 2
a laser fiber configured to transmit laser energy from a proximal end of the catheter to a distal end of the catheter
Implementation Method 3
a vacuum lumen configured to transmit a vacuum from a proximal end of the catheter to a distal end of the catheter
Implementation Method 4
an inert gas lumen configured to transmit an inert gas from a proximal end of the catheter to a distal end of the catheter
Data Source
AI summary
Exemplary embodiments of the present disclosure include systems and methods for treatment of occlusions, including coronary artery chronic total occlusions.