Subintimal Tracking Catheter for Chronic Total Occlusion Bypass
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Solution Overview
Problem
Current endovascular devices and methods for treating chronic total occlusions are inefficient, pose a high risk of vessel perforation, and often fail to cross the occlusion, making them ineffective and unsafe.
Innovation Solution
The use of devices and methods that exploit the intramural (subintimal) space of the vascular wall to facilitate treatment, including visualizing the vessel wall boundary, protecting it from perforation, bypassing occlusions, and removing them.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional endovascular devices are used to treat chronic total occlusions, then the procedure can be performed with standard equipment, but the devices often fail to cross the occlusion and pose a high risk of vessel perforation
Solution Approach 1:
The patent introduces a subintimal tracking catheter as an intermediary device that navigates through the subintimal space (between the intima and media layers) rather than attempting to cross the occlusion through the true lumen. This intermediary pathway allows the device to bypass the occlusion safely without risking perforation of the vessel wall, while still enabling delivery of treatment devices to the distal vessel.
Solution Approach 2:
The invention transitions from a two-dimensional approach (attempting to cross the occlusion linearly through the blocked lumen) to utilizing a three-dimensional pathway through the subintimal space. By moving into this additional dimensional space within the vessel wall, the device can circumvent the occlusion and re-enter the true lumen distally, significantly improving the success rate of crossing chronic total occlusions.
2Loss of information
If physicians attempt to visualize the native vessel lumen through occlusions using conventional methods, then standard imaging techniques can be used, but accurate direction of endovascular devices toward the visualized lumen cannot be achieved
Solution Approach 1:
The patent employs radiopaque markers and contrast-enhanced imaging that create visual contrasts (analogous to color changes) to delineate the subintimal space and guide catheter navigation. These visual indicators allow physicians to track the device position and orientation relative to the vessel anatomy, enabling accurate direction even when the native lumen is not directly visualizable through the occlusion.
3Reliability
If bypass surgery is performed for patients with chronic total occlusions, then complete occlusion can be bypassed, but the procedure becomes undesirably invasive
Solution Approach 1:
The invention extracts the problematic occluded segment from the treatment pathway by navigating around it through the subintimal space rather than attempting to clear it directly or performing surgical bypass. This extraction approach allows the procedure to continue percutaneously through the vascular system, avoiding the need for open surgical bypass while still achieving the therapeutic goal of restoring blood flow.
Data Source
AI summary
Devices and methods for the treatment of chronic total occlusions are provided. One disclosed embodiment comprises a method of facilitating treatment via a vascular wall defining a vascular lumen containing an occlusion therein. The method includes providing a first intravascular device having a distal portion with a concave side, inserting the first device into the vascular lumen, positioning the distal portion in the vascular wall, and orienting the concave side of the distal portion toward the vascular lumen.


