Balloon Catheter Subintimal Reentry Guiding
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Solution Overview
Problem
Current catheter systems for subintimal bypassing of chronic total occlusions in blood vessels are complex and costly, making it difficult to effectively advance a guidewire through the true lumen proximal to the occlusion, across it, and back into the true lumen distal to the occlusion, especially in irregularly shaped and tortuous arteries.
Innovation Solution
A catheter system with a shaft and multiple balloons is used in conjunction with a subintimal reentry guidewire, where the balloons are inflated to bend or rotate the catheter shaft, orienting the distal tip towards the true lumen, facilitating the guidewire's re-entry into the true lumen distal to the occlusion.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional medical guidewire is used to penetrate the fibrous cap of chronic total occlusion, then the guidewire may fail to penetrate the lesion, but using stiffer guidewires increases the risk of vessel damage and procedural complexity
Solution Approach 1:
The invention segments the penetration process into two distinct phases: first creating a subintimal track through the occlusion using a compliant guidewire, then using a re-entry device to puncture the vessel wall and enter the distal true lumen. This segmentation avoids the need for a single stiff guidewire to penetrate the entire occlusion, reducing vessel damage risk while maintaining penetration success.
Solution Approach 2:
The invention introduces the subintimal space as an intermediary pathway between the proximal and distal true lumens. By traveling through this intermediate space rather than directly through the occluded lumen, the guidewire system can bypass the fibrous cap barrier without requiring excessive force that would damage the vessel.
2Productivity
If subintimal recanalization technique is used to bypass occlusion, then blood flow can be restored, but re-entry devices become complex and costly
Solution Approach 1:
The catheter system integrates multiple functions into a single device: it includes both the subintimal tracking capability and the re-entry puncture function in one integrated catheter assembly. This multi-functionality eliminates the need for separate complex re-entry devices, reducing overall system complexity and cost while maintaining blood flow restoration efficiency.
Solution Approach 2:
The invention merges the guidewire, catheter, and re-entry needle into a single integrated assembly. The catheter shaft encompasses both the guidewire and re-entry needle, allowing the operator to perform subintimal tracking and re-entry puncture using one unified device rather than multiple separate components.
3Adaptability or versatility
If catheter is advanced through tortuous and irregular arteries to reach treatment site, then treatment can be performed, but advancement difficulty increases
Solution Approach 1:
The catheter shaft is constructed with flexible materials that allow it to conform to the tortuous and irregular geometry of patient arteries. This flexibility enables the catheter to navigate complex vascular pathways without requiring excessive force or complex manipulation, improving ease of operation while maintaining adaptability to various arterial configurations.
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 approach allows for effective subintimal bypassing of occlusions, improving the success rate of recanalization by stabilizing the catheter in the subintimal space and directing the guidewire into the true lumen, thereby restoring blood flow, and is more cost-effective compared to existing systems.
Implementation Method 1
When the catheter is disposed in the subintima of a vessel and the first balloon and the second balloon are inflated, the catheter shaft bends such that a tip of the catheter shaft distal of the first and second balloons is oriented towards a true lumen of the vessel
Data Source
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AI summary
A catheter for subintimally bypassing an occlusion in a vessel includes a catheter shaft including a guidewire lumen disposed therethrough and having a shaft longitudinal axis, at least two balloons coupled to an exterior of the catheter shaft such that longitudinal axes of the balloons are in a common plane with the shaft longitudinal axis when uninflated and with no external forces on the catheter. The balloons are configured such that when the catheter is disposed in the subintima of a vessel and the balloons are inflated, a tip of the catheter shaft is oriented towards a true lumen of the vessel distal of the occlusion.