Subintimal Reentry for Crossing Chronic Total Occlusions
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Solution Overview
Problem
Existing endovascular devices struggle to efficiently cross chronic total occlusions in arteries, often leading to inefficient procedures, vessel perforation risks, or failure to establish blood flow, with bypass surgery being the preferred but less invasive alternatives.
Innovation Solution
Devices and methods that exploit the vascular wall by passing an endovascular device into and out of the vascular lumen, utilizing a first intravascular device with an aperture and a reentry device with a distal tip to navigate through the occlusion, creating a channel between the adventitia and intima, and establishing a blood flow path.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If commonly known endovascular devices and techniques are used to cross chronic total occlusions, then the procedure can be performed with standard equipment, but the procedure is inefficient (time consuming), has high risk of vessel perforation, or fails to cross the occlusion
Solution Approach 1:
The patent applies subintimal access technique by intentionally navigating the device through the vessel wall into the subintimal space (outside the true lumen) rather than attempting to force passage through the occluded lumen. This inverted approach allows the device to bypass the occlusion by traveling through the vessel wall and re-entering the lumen distal to the occlusion, thereby resolving the contradiction between reliability of crossing and procedural efficiency.
Solution Approach 2:
The patent uses the vascular wall and subintimal space as an intermediary pathway to cross the occlusion. Instead of directly confronting the occlusion within the lumen, the device utilizes the subintimal space as a mediator route, passing through the vessel wall, traversing the occlusion site in the subintimal plane, and re-entering the true lumen, thus achieving reliable crossing while improving procedural efficiency.
2Measurement precision
If physicians attempt to visualize the native vessel lumen and direct endovascular devices through it, then the treatment targets the correct anatomical path, but physicians cannot accurately direct devices toward the visualized lumen or advance devices through the lesion
Solution Approach 1:
Instead of attempting to accurately direct devices through the visualized lumen (which proves difficult), the patent inverts the approach by deliberately directing the device through the vessel wall into the subintimal space. This eliminates the need for precise lumen targeting, as the device follows a more accessible subintimal pathway that is easier to navigate, thereby resolving the contradiction between measurement precision and ease of operation.
Solution Approach 2:
The patent extracts the device from the constrained lumen pathway and places it into the subintimal space, removing the device from the difficult-to-navigate lumen environment. This extraction allows the device to travel through a more accessible pathway where advancement is easier, resolving the contradiction between accurate direction and ease of operation.
3Reliability
If bypass surgery is performed to treat chronic total occlusions, then effective blood flow restoration is achieved, but the procedure is more invasive than endovascular techniques
Solution Approach 1:
The patent replaces the mechanical surgical bypass system with an endovascular subintimal access system. Instead of performing open surgery with external bypass grafts, the device utilizes the subintimal space as a natural conduit, substituting the need for surgical anastomosis and external grafts with a minimally invasive endovascular approach that achieves similar blood flow restoration while reducing invasiveness.
Solution Approach 2:
The patent uses the subintimal space as an intermediary pathway to achieve blood flow restoration without requiring open surgery. By utilizing this natural anatomical space as a mediator route, the procedure achieves effective revascularization while avoiding the invasiveness of bypass surgery, thereby resolving the contradiction between reliability of blood flow restoration and harmful factors of invasiveness.
Data Source
AI summary
The present disclosure is directed a method of facilitating treatment via a vascular wall defining a vascular lumen containing an occlusion therein. The method may include providing a first intravascular device having a distal portion and at least one aperture and positioning the distal portion of the first intravascular device in the vascular wall. The method may further include providing a reentry device having a body and a distal tip, the distal tip having a natural state and a compressed state and inserting the distal tip, in the compressed state, in the distal portion of the first intravascular device. The method may further include advancing the distal tip, in the natural state, through the at least one aperture of the first intravascular device.