Re-entry Catheter Balloon Stabilization for Chronic Total Occlusion
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Solution Overview
Problem
Current medical devices face challenges in consistently and reliably redirecting subintimally advanced guidewires back into the true lumen of arteries for treating chronic total occlusions, especially in arteries with severe calcified plaque, where guidewires tend to deviate and become trapped in subintimal tracts.
Innovation Solution
An occlusion bypassing apparatus comprising an outer shaft component with a side port, a needle component, and an inflatable balloon, where the needle component is slidably disposed within the shaft and the balloon has a flattened profile in an inflated state to stabilize the apparatus within a subintimal space, allowing for the re-entry of the guidewire into the true lumen.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a conventional guidewire is used to penetrate through calcified atherosclerotic plaque, then the guidewire can cross the occlusion, but the guidewire tends to deviate and penetrate through the intima creating a subintimal tract, making it difficult to reenter the true lumen
Solution Approach 1:
The patent introduces a re-entry catheter with a laterally deployable needle as an intermediary device. The needle is deployed from the catheter body to puncture the intimal layer and re-enter the true lumen distal to the occlusion. This intermediary mechanism bridges the gap between the subintimal tract and the true lumen, solving the reentry difficulty without requiring direct guidewire manipulation through the intima.
Solution Approach 2:
The re-entry catheter is segmented into distinct functional components: a catheter body for subintimal navigation, a laterally deployable needle for intimal puncture, and a mechanism for needle deployment and retraction. This segmentation allows each component to perform its specific function optimally - the catheter navigates the subintimal space while the needle handles the precise reentry task.
2Productivity
If the artery is totally occluded by hard, calcified atherosclerotic plaque, then the guidewire can be advanced distal to the lesion, but the guidewire remains trapped within the subintimal tract and cannot return to the true lumen
Solution Approach 1:
The laterally deployable needle acts as an intermediary tool that enables transition from the subintimal tract to the true lumen. The needle is deployed perpendicular to the catheter axis, puncturing the intimal layer to create a reentry pathway. This intermediary mechanism ensures reliable recanalization by providing a controlled path back into the true lumen, independent of the difficulty of crossing the occlusion itself.
3Adaptability or versatility
If various catheter systems with laterally deployable cannulae are used to puncture the intimal layer, then reentry into the true lumen can be achieved, but consistent and reliable redirection of subintimally advanced guidewires remains challenging
Solution Approach 1:
The re-entry catheter is designed as a universal system that combines multiple functions in one device: subintimal navigation, lateral needle deployment, guidewire passage, and retraction. This multi-functionality ensures consistent performance across different cases, as the same integrated system handles all aspects of the reentry procedure, reducing variability compared to combining separate devices.
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 apparatus effectively stabilizes itself within the subintimal space, enabling reliable re-entry of the guidewire into the true lumen, facilitating successful recanalization of chronic total occlusions and improving the efficacy of vascular interventions.
Implementation Method 1
The inflatable balloon is in fluid communication with the inflation lumen of the outer shaft component. The balloon includes a body portion that is disposed distal to the side port of the outer shaft component, and the body portion of the balloon has a flattened profile in an inflated state with first and second chambers that laterally extend from opposing sides of the outer shaft component for stabilizing the apparatus within a subintimal space.
Data Source
Figure 1
Figure 1A~1C
Figure 2
AI summary
An occlusion bypassing apparatus 100 for re-entering the true lumen of a vessel includes an outer shaft component 102, a needle component 134, and an inflatable balloon 122. The outer shaft component has a side port proximal to a distal end thereof and a needle lumen there-through that includes a curved distal portion that terminates at the side port of the outer shaft component. The needle component is configured to be slidably disposed within the needle lumen of the outer shaft component. The inflatable balloon includes a body portion that is disposed distal to the side port of the outer shaft component, and the body portion of the balloon has a flattened profile in an inflated state with first and second chambers that laterally extend from opposing sides of the outer shaft component for stabilizing the apparatus within a subintimal space.