Angled Needle Bending Catheter for True Lumen Re-entry
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Solution Overview
Problem
Current medical devices face challenges in consistently and reliably directing guidewires or other devices from a subintimal space back into the true lumen of a blood vessel for treating chronic total occlusions, especially in arteries with severe narrowing or calcified plaque, where conventional methods struggle to penetrate and re-enter the true lumen.
Innovation Solution
The development of an occlusion bypassing apparatus with a shaft component and a needle component that can be configured to bend, allowing the distal portion to be angled away from the longitudinal axis, anchored by a balloon within the subintimal tract, facilitating the re-entry into the true lumen of the vessel.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a conventional guidewire is used to penetrate through calcified atherosclerotic plaque, then the guidewire may penetrate the intima and create a subintimal tract, but the guidewire becomes trapped within the subintimal tract and cannot reliably re-enter the true lumen
Solution Approach 1:
The catheter is divided into distinct functional segments: a shaft component for navigation, a needle component for puncture, and a balloon component for anchoring. This segmentation allows each component to perform its specific function optimally, with the needle specifically designed to penetrate the vessel wall and guide re-entry into the true lumen
Solution Approach 2:
The needle component acts as an intermediary tool that bridges the subintimal space and the true lumen. The needle is advanced through the catheter shaft to puncture the vessel wall from the subintimal side, providing a controlled pathway back into the true lumen that the guidewire alone cannot achieve
2Productivity
If the artery is totally occluded by hard, calcified atherosclerotic plaque, then the guidewire deviates to one side and creates a subintimal tract, but the distal end remains trapped and cannot reach the true lumen distal to the lesion
Solution Approach 1:
The catheter shaft is advanced through the subintimal tract to the distal side of the occlusion before the needle component is deployed. The balloon is inflated to anchor the catheter in place, establishing a stable platform from which the needle can then puncture the vessel wall and re-enter the true lumen. This preliminary positioning and anchoring enables controlled re-entry rather than attempting to steer the guidewire through the entire occlusion in one motion
Solution Approach 2:
The needle component serves as an intermediary device that creates a controlled puncture pathway from the subintimal space into the true lumen. The needle is advanced through the catheter shaft, punctures the vessel wall at a controlled location, and provides a guide for re-entering the true lumen, thereby mediating the transition from subintimal to intraluminal position
3Reliability
If laterally deployable cannulae are used to puncture the intimal layer and re-enter the true lumen, then re-entry can be achieved, but the devices are complex and require precise positioning
Solution Approach 1:
The catheter shaft serves multiple functions: it acts as a delivery system for the needle component, provides anchoring through the balloon, and serves as a guide for the needle during puncture. This multi-functionality reduces the need for separate specialized devices while maintaining reliable re-entry capability
Solution Approach 2:
The needle component is nested within the catheter shaft during delivery and deployment. The needle is advanced through the shaft lumen to the puncture site, then protrudes from the shaft to perform the puncture. This nested configuration allows the needle to be stored and deployed within a single catheter assembly, reducing overall system complexity compared to separate laterally deployable cannulae systems
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 apparatus effectively stabilizes the device within the subintimal tract and enables reliable re-entry into the true lumen, improving the success rate of recanalization procedures for chronic total occlusions by providing a stable and controlled mechanism for guidewire re-entry.
Implementation Method 1
When a needle component of the occlusion bypassing apparatus is advanced within the shaft component, the needle component may bend or curve a distal tip portion of the shaft component away from a longitudinal axis of the apparatus
Data Source
Figure 1~1AA
Figure 2~3
Figure 2A~2B
AI summary
Occlusion bypassing apparatuses are disclosed for re-entering the true lumen of a vessel after subintimally bypassing an occlusion in a vessel. The occlusion bypassing apparatuses include a shaft component and a needle component slidably disposed within the shaft component and having an angled configuration when deployed. In embodiments hereof, the needle component has an angled distal tip segment that may be utilized to selectively bend a flexible distal portion of the shaft component in order to extend the flexible distal portion towards the true lumen of the vessel. The needle component is distally advanced relative to the shaft component to pierce through the intima of the vessel and thereafter enter the true lumen.