Wire-Guided Recanalization Catheter with Rotary Ablation
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Solution Overview
Problem
Chronic total occlusions in blood vessels pose challenges for recanalization, as existing methods struggle to penetrate and re-enter the true lumen from a subintimal space, making it difficult to effectively restore blood flow.
Innovation Solution
A recanalization catheter assembly featuring a guidewire lumen, a guide member, and a rotary ablation tool, where the guide member advances in the subintimal space and the rotary ablation tool ablates the occlusion in the true lumen, with an optional cutter for tissue dissection, facilitating navigation and occlusion removal without the need for subintimal re-entry.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Stability of the object's composition
If a guide member is advanced in the subintimal space, then navigation stability is improved, but the ability to ablate the occlusion in the true lumen is compromised
Solution Approach 1:
The catheter assembly is divided into distinct functional segments: a guide member for subintimal navigation and a rotary ablation tool for true lumen occlusion removal. This segmentation allows each component to perform its specialized function independently while being integrated in a single assembly, resolving the contradiction between navigation stability and ablation effectiveness.
Solution Approach 2:
The guide member acts as an intermediary that provides stable navigation through the subintimal space while the rotary ablation tool simultaneously works in the true lumen. The guide member's stability serves as a foundation that enables the ablation tool to operate effectively, mediating between the two conflicting requirements.
2Reliability
If a rotary ablation tool is used in the true lumen, then occlusion removal is improved, but device deflection and navigation control deteriorate
Solution Approach 1:
The guide member serves as a stabilizing intermediary that counteracts the deflection caused by the rotary ablation tool. By advancing the guide member in the subintimal space, it provides a stable track that maintains navigation control while allowing the ablation tool to effectively remove the occlusion.
Solution Approach 2:
Different parts of the catheter assembly have different functional qualities: the guide member is optimized for navigation and stability in the subintimal space, while the rotary ablation tool is optimized for occlusion removal in the true lumen. This local differentiation of qualities allows each component to excel at its specific function without compromising the other.
3Reliability
If subintimal re-entry is attempted, then recanalization path creation is improved, but procedural complexity and time increase
Solution Approach 1:
The guide member and rotary ablation tool are merged into a single integrated catheter assembly, allowing simultaneous advancement through the subintimal space and true lumen. This combination eliminates the need for separate re-entry devices and procedures, reducing overall procedural complexity while maintaining effective recanalization path creation.
Solution Approach 2:
The guide member is advanced through the subintimal space in advance to establish a stable track before the rotary ablation tool begins occlusion removal. This preliminary action prepares the pathway and stabilizes the system, enabling subsequent ablation to proceed more efficiently without requiring additional re-entry maneuvers.
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 solution enables effective recanalization of occluded blood vessels by stabilizing the rotary ablation tool and preventing deflection, allowing for successful passage through occlusions and restoration of blood flow without the need for additional re-entry devices.
Implementation Method 1
a rotary ablation tool extends distally from the distal opening alongside the guide member
Data Source
AI summary
A recanalization catheter assembly for recanalization of an occluded blood vessel is disclosed. The recanalization catheter assembly includes an elongate shaft having a tubular portion, a guide member, and a rotary ablation tool. The tubular portion includes a distal opening, from where the rotary ablation tool extends distally. The guide member extends distal of the distal opening and includes a guidewire lumen to receive a guidewire therethrough. The guide member is configured to advance over the guidewire in a subintimal space between a first tissue layer and a second tissue layer of a wall of the blood vessel, while the rotary ablation tool is advanced in a true lumen of the blood vessel.