Subintimal Bypass Lumen Creation for Chronic Total Occlusion
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Solution Overview
Problem
Current CTO treatment procedures are challenging due to the difficulty in determining whether devices are within the vessel lumen or sub-intimal space, leading to uncertainty in device placement and potential safety risks during balloon angioplasty.
Innovation Solution
A method involving a first elongated body with an impedance detector and magnetic elements to navigate between the tunica media and intima, creating a bypass lumen, and a balloon catheter to expand it, ensuring accurate device placement and blood flow restoration.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If traditional balloon angioplasty procedures are used to treat CTO, then the procedure can be performed with simple equipment, but the wire cannot successfully pierce the complete blockage and the procedure fails
Solution Approach 1:
The procedure is divided into distinct phases: first device antegrade approach, second device retrograde approach, subintimal space creation, and lumen re-entry. This segmentation allows each device to perform specific functions independently, increasing the overall success rate of CTO treatment by breaking down the complex task of piercing complete blockage into manageable steps.
Solution Approach 2:
The balloon catheter is nested within the elongated body, allowing the balloon to be delivered through the complex navigation path created by the elongated body. This nesting enables the balloon to reach the occlusion site through the subintimal space and perform angioplasty without requiring the entire complex device assembly to be in the lumen simultaneously.
2Reliability
If two devices are used for CTO treatment (one antegrade and one retrograde), then the procedure can potentially succeed, but it is difficult to determine whether devices are in the lumen or subintimal space leading to uncertainty
Solution Approach 1:
The system incorporates detectors that provide real-time feedback on device location and orientation. These detectors enable the physician to determine whether devices are in the lumen or subintimal space, eliminating uncertainty in device placement and allowing for informed decision-making during the procedure.
Solution Approach 2:
The elongated body acts as an intermediary structure that guides the balloon catheter through the subintimal space. This intermediary provides a defined pathway and structural support, making it easier to track device location and ensuring the balloon reaches the correct position for effective CTO treatment.
3Reliability
If the physician uses current CTO treatment methods, then the procedure can be attempted, but several guesses are required as to where the distal portions of the two devices are relative to one another, calling into question safety
Solution Approach 1:
The detectors provide precise measurement feedback on device positioning, eliminating the need for guesses about relative device locations. This real-time information allows the physician to accurately determine when devices are properly positioned and when to proceed with balloon inflation, significantly improving procedural safety.
Solution Approach 2:
The system replaces mechanical trial-and-error positioning with detector-based spatial awareness. Instead of relying on physical manipulation and guessing device locations, the detectors provide electronic feedback on precise device positions, enabling accurate positioning without mechanical uncertainty.
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
The method provides precise location sensing and safe creation of a bypass lumen, enhancing the effectiveness and safety of CTO treatment by ensuring accurate device positioning and blood flow restoration.
Implementation Method 1
the first elongated body comprises an impedance detector, the impedance detector configured to obtain first impedance data within the lumen and second impedance data within the wall of the artery
Implementation Method 2
the distal tip of the first elongated body is magnetically attracted to the distal tip of the second elongated body
Data Source
AI summary
Devices, systems, and methods to generate a bypass lumen in connection with a chronic total occlusion procedure. An exemplary method comprises introducing at least part of a first elongated body into a lumen of an artery so that a distal tip of the first elongated body is positioned on a first side of an occlusion within the lumen of the artery; inserting the distal tip of the first elongated body into a wall of the artery in between a tunica media and a tunica intima of the artery; advancing the distal tip of the first elongated body in between the tunica media and the tunica intima; and further advancing the distal tip of the first elongated body back into the lumen of the artery to generate a bypass lumen and so that the distal tip is positioned on an opposite second side of the occlusion within the lumen.