Steerable Atherectomy Catheter Navigating Tortuous Vessels
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Solution Overview
Problem
Current treatments for Peripheral Arterial Disease (PAD) face challenges in navigating tortuous anatomy and efficiently clearing occlusions in blood vessels due to limitations in existing atherectomy systems, including long procedure times, embolic debris, and high rates of restenosis and stent failure.
Innovation Solution
A steerable atherectomy catheter system with a flexible body and a cutting assembly that includes a housing and cutter, allowing for controlled deflection and rotation to navigate through tortuous vessels, remove occlusive materials, and prevent vessel wall damage, while maintaining a straight configuration when not in use.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If a traditional atherectomy device with a long receptacle is used, then plaque can be collected, but the device is limited to straight lumens and requires multiple catheter exchanges for tortuous vessels
Solution Approach 1:
The catheter is divided into multiple articulation segments that can be independently controlled. The distal portion can be deflected relative to the proximal portion, allowing the catheter to navigate tortuous vessels without requiring multiple exchanges. This segmentation enables the catheter to adapt to complex vascular anatomy while maintaining a single continuous device.
Solution Approach 2:
The catheter incorporates dynamic articulation capabilities where the distal portion can be actively deflected and repositioned during the procedure. This dynamic control allows the operator to steer the catheter tip through bent and twisted vessels, providing adaptability to tortuous anatomy without requiring multiple static catheter exchanges.
2Productivity
If a rotating cutter is used to remove plaque, then occlusive material can be excised, but embolic debris is produced that can dislodge and block downstream vessels
Solution Approach 1:
A filter is introduced as an intermediary component within the catheter system that captures embolic debris generated by the rotating cutter. The filter acts as a mediator between the cutting action and the downstream circulation, trapping plaque particles and preventing them from dislodging and blocking downstream vessels while allowing the efficient plaque removal to continue.
Solution Approach 2:
The system converts the potentially harmful embolic debris into a controlled collection process. The debris generated by the cutter is channeled through the filter where it is captured and contained, transforming the harmful scattered particles into a controlled, collected material that can be safely removed from the vascular system.
3Productivity
If balloon angioplasty is used to expand the artery, then luminal diameter is increased, but barotrauma and vessel wall dissection occur leading to high restenosis rates
Solution Approach 1:
The patent replaces the high-pressure balloon expansion mechanism with a gentle atherectomy cutting mechanism. Instead of using mechanical force to compress and displace plaque (which causes barotrauma and dissection), the rotating cutter selectively removes occlusive material through controlled excision, restoring luminal diameter without damaging the vessel wall and thereby reducing restenosis rates.
4Adaptability or versatility
If multiple devices are used for atherectomy, then plaque can be removed from different angles, but procedure time increases significantly
Solution Approach 1:
The catheter is designed with universal multi-functionality, incorporating both articulation capabilities and a rotating cutter that can remove plaque from multiple angles. The distal articulation segment can be deflected to position the cutter at various angles relative to the vessel wall, providing the versatility of multiple devices while maintaining a single integrated catheter that reduces procedure time by eliminating repeated catheter exchanges.
Data Source
Figure 1A~1B
Figure 2A
Figure 2B~3A
AI summary
The devices and methods generally relate to treatment of occluded body lumens. In particular, the present devices and method relate to removal of the occluding material from the blood vessels as well as other body lumens.