Subintimal Device for Chronic Total Occlusion Crossing
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Solution Overview
Problem
Current endovascular devices and techniques for treating chronic total occlusions are inefficient, pose a high risk of vessel perforation, and often fail to cross the occlusion, making it difficult for physicians to visualize the native vessel lumen and accurately direct devices.
Innovation Solution
The use of subintimal devices and methods that provide visualization of the occluded vascular lumen and mechanical protection for the artery, along with guide wire support devices that enhance wire stiffness and directional control, to facilitate crossing of chronic total occlusions.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If conventional endovascular devices and techniques are used to treat chronic total occlusions, then the procedure is simpler, but the efficiency is low (time-consuming) and the risk of vessel perforation is high
Solution Approach 1:
The patent applies preliminary action by first placing a subintimal device around the occlusion site before attempting to cross it. This preliminary positioning provides a safety mechanism that prevents vessel perforation during subsequent crossing attempts, while also improving overall procedure efficiency by reducing the need for repeated failed attempts
Solution Approach 2:
The subintimal device acts as an intermediary element between the physician and the occluded vessel. It provides visualization of the vessel lumen and mechanical protection simultaneously, mediating the interaction between the crossing devices and the vulnerable vessel wall, thereby reducing both procedure time and perforation risk
2Measurement precision
If conventional endovascular techniques are used, then the device complexity is lower, but the ability to visualize the native vessel lumen and accurately direct devices is poor
Solution Approach 1:
The subintimal device is designed with multi-functionality, serving as both a protective sheath and a visualization aid. This universal device performs multiple functions simultaneously, improving visualization accuracy without requiring additional separate devices, thereby limiting the increase in overall system complexity
Solution Approach 2:
The patent employs a nested structure where the subintimal device encompasses the crossing devices within its structure. This nesting arrangement allows the outer subintimal device to provide visualization and protection while the inner devices perform their specific functions, achieving high measurement precision through a hierarchical rather than horizontally complex design
3Reliability
If conventional techniques are used to cross chronic total occlusions, then the procedure is faster, but the efficacy to cross the occlusion is poor
Solution Approach 1:
By performing the subintimal device placement as a preliminary action before attempting to cross the occlusion, the patent establishes a successful pathway that significantly increases the likelihood of successful occlusion crossing. This preliminary step prevents failed attempts that would waste time, thereby improving efficacy without substantially increasing procedure duration
Solution Approach 2:
The subintimal device serves as an intermediary pathway that facilitates the crossing of the occlusion. It provides mechanical support and direction for the crossing devices, increasing the success rate of occlusion crossing while maintaining reasonable procedure timing through its streamlined design
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 an intravascular device having a distal portion with a lumen extending therein; inserting the device into the vascular lumen; positioning the distal portion in the vascular wall; and directing the distal portion within the vascular wall.