Endovascular Orienting Element for Crossing Total Occlusions
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Solution Overview
Problem
Current endovascular devices are inefficient, risky, and often fail to cross chronic total occlusions in arteries, making it difficult to establish blood flow past these blockages, which can lead to severe health issues such as angina or limb amputation.
Innovation Solution
The use of a device with a distal shaft and an orienting element, comprising inflatable members, that allows for subintimal access by positioning the orienting element between the adventitia and intima of the artery, orienting the device relative to the true lumen, and advancing a re-entry device through an aperture to establish fluid communication across the occlusion.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If common endovascular devices are used to cross chronic total occlusions, then the procedure may be performed with standard equipment, but the procedure is inefficient, has high risk of vessel perforation, or fails to cross the occlusion
Solution Approach 1:
The device is divided into distinct functional segments: a shaft for navigation, an orienting element with inflatable members for positioning, and a re-entry device for crossing the occlusion. This segmentation allows each component to perform its specific function optimally, improving reliability while reducing harmful effects through controlled, stepwise progression.
Solution Approach 2:
The orienting element is inflated within the vessel wall before the re-entry device attempts to cross the occlusion. This preliminary action establishes proper orientation and positioning, ensuring that subsequent crossing attempts are more likely to succeed and less likely to cause vessel perforation.
2Ease of operation
If physicians use current endovascular techniques, then they can attempt to treat occlusions, but they cannot accurately direct devices toward the visualized lumen or advance devices through the lesion
Solution Approach 1:
The orienting element acts as an intermediary between the shaft and the re-entry device. It provides a reference framework that mediates the transition from vague fluoroscopic visualization to precise device positioning, enabling accurate direction toward the lumen without requiring perfect visualisation.
Solution Approach 2:
The inflatable members of the orienting element create visible changes in the vessel wall appearance during fluoroscopy, allowing physicians to track device position and orientation. These visual changes serve as markers that improve measurement precision for lumen localization.
3Reliability
If bypass surgery is performed for chronic total occlusions, then blood flow can be restored, but the procedure is highly invasive compared to endovascular techniques
Solution Approach 1:
The re-entry device is nested within the orienting element, which itself is on the shaft. This nested configuration allows the complex functionality of bypass-like blood flow restoration to be achieved through a single, relatively simple endovascular catheter system, reducing procedural invasiveness while maintaining efficacy.
Solution Approach 2:
The device transitions from navigating within the true lumen to accessing the intramural space and then re-entering the distal lumen. This dimensional transition through the vessel wall provides a new pathway for treating occlusions that avoids the invasiveness of external bypass surgery while achieving the same physiological outcome.
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 method effectively bypasses total occlusions, reducing the risk of vessel perforation and improving the efficacy of blood flow restoration, offering a less invasive alternative to bypass surgery.
Implementation Method 1
positioning an orienting device within an artery... including an inflatable member positioned within the intramural space
Data Source
AI summary
The present disclosure is directed to a device. The device may include a distal shaft defining a central lumen and an orienting element comprising at least one inflatable member. Wherein a first portion of the orienting element extending from the shaft in a first direction and a second portion of the orienting element extending from the shaft in a second direction. Further, wherein the second direction is substantially opposite the first direction.