Intramural Orienting Device for CTO Crossing and Vessel Protection
Find Innovative SolutionsGenerate Solutions
Solution Overview
Problem
Existing endovascular devices struggle to efficiently cross chronic total occlusions (CTOs) due to inefficiency, high risk of vessel perforation, and poor visualization, often requiring invasive bypass surgery.
Innovation Solution
Devices and methods that exploit the subintimal space of the vascular wall to visually define the vessel boundary, protect against perforation, and bypass the occlusion by using radiopaque elements, atraumatic tips, and flexible designs to navigate and re-enter the native lumen.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional endovascular devices are used to cross chronic total occlusions, then the procedure may successfully treat the occlusion, but the risk of vessel perforation increases significantly
Solution Approach 1:
The patent introduces a subintimal device as an intermediary element that navigates through the subintimal space (between the intima and media layers) rather than forcing devices through the occluded true lumen. This intermediary pathway avoids direct contact with the vulnerable vessel wall boundary, significantly reducing perforation risk while still enabling successful occlusion crossing and subsequent re-entry into the true lumen distal to the occlusion.
2Loss of information
If physicians attempt to visualize the native vessel lumen through occlusions using conventional methods, then some visualization may be achieved, but accurate direction of endovascular devices toward the visualized lumen remains difficult
Solution Approach 1:
The patent replaces conventional mechanical visualization methods (direct imaging through the occlusion) with a navigation system that uses fluoroscopic landmarks and a deliverable subintimal device with radiopaque markers. The device's progression through the subintimal space and its re-entry into the true lumen provides indirect but accurate positional information, enabling precise device direction without requiring direct visualization of the entire vessel lumen through the occlusion.
3Productivity
If physicians force devices through occlusions using conventional techniques, then occlusion crossing may be achieved, but the procedure becomes time-consuming and inefficient
Solution Approach 1:
The patent segments the occlusion crossing procedure into distinct phases: (1) delivery of the subintimal device through the occlusion via the subintimal space, (2) navigation through the subintimal pathway, and (3) re-entry into the true lumen distal to the occlusion. This segmentation allows each phase to be optimized independently, significantly improving overall procedural efficiency and success rate compared to forcing a single device through the entire occlusion in one attempt.
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
Enhances visualization of occluded vessels, minimizes perforation risk, and facilitates safe bypass of occlusions, improving procedural efficiency and safety.
Implementation Method 1
placement of a circumferential radiopaque element in the subintimal space
Data Source
Figure 1~1B
Figure 2~3B
Figure 4~4B
AI summary
The present invention relates to a system for facilitating treatment via a vascular wall defining a vascular true lumen (116) containing an occlusion (120) therein, the system comprising: an intramural orienting device (3400) including an outer shaft (3410) connected to a proximal end (3446) of an orienting element (3440), and an inner shaft (3420) extending through the outer shaft (3410) and the orienting element (3440), wherein a distal end of the inner shaft (3420) is connected to a distal end (3448) of the orienting element (3440); wherein the inner shaft (3420) includes a lumen extending therethrough to a side port (3425) adjacent the orienting element (3440); wherein the orienting element (3440) comprises a metallic tube with cuts made to define two wings (3442A, 3442B), wherein contracting the proximal end (3446) of the orienting element (3440) toward the distal end (3448) of the orienting element (3440) extends the wings (3442A, 3442B) outwardly in a substantially planar manner.