Single Lumen Balloon Catheter for Tortuous Vessel Navigation
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Solution Overview
Problem
Conventional balloon catheters with guidewire lumens and ports face difficulties navigating tortuous distal vessel pathways due to their design, which limits their ability to access smaller diameter vessels without sacrificing stiffness and pushability.
Innovation Solution
A balloon catheter with a single continuous lumen from the proximal to the distal end, eliminating the need for a guidewire port and lumen, featuring a compliant balloon with a wire member to prevent axial stretching during inflation, allowing navigation through smaller diameter vessels with reduced outer diameter and increased inner diameter for ancillary devices.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If a guidewire lumen and guidewire port are included in the balloon catheter, then the catheter can be advanced over a guidewire, but the catheter becomes difficult to navigate through tortuous distal vessel pathways and has a larger outer diameter
Solution Approach 1:
The patent removes the guidewire lumen and guidewire port from the catheter design, eliminating the guidewire dependency entirely. The catheter is designed to be self-contained with a single inflation lumen, allowing it to navigate tortuous vessels independently without requiring a separate guidewire lumen structure.
Solution Approach 2:
The single lumen in the catheter serves multiple functions - it acts as both the structural core of the catheter and the inflation lumen. This eliminates the need for separate guidewire and inflation lumens, reducing overall catheter complexity while maintaining navigability through tortuous pathways.
2Reliability
If a guidewire lumen extends through the catheter shaft, then guidewire support is provided, but the inner diameter available for ancillary devices is reduced
Solution Approach 1:
The guidewire lumen is completely removed from the catheter design. The catheter no longer requires a separate lumen for guidewire passage, thereby maximizing the inner diameter available for ancillary devices while maintaining catheter functionality through alternative design features.
3Ease of operation
If a guidewire lumen is present in the catheter, then guidewire tracking is enabled, but the catheter outer diameter increases reducing ability to navigate smaller vessels
Solution Approach 1:
The guidewire lumen and associated guidewire tracking capability are removed from the design. The catheter achieves reduced outer diameter by eliminating this structural component, enabling navigation through smaller vessels while maintaining self-contained functionality.
Solution Approach 2:
The single lumen serves dual purposes as both the structural element and the inflation channel, eliminating the need for separate guidewire and inflation lumens. This integration reduces the overall catheter profile while maintaining all necessary functions.
4Adaptability or versatility
If multiple lumens are used in the catheter shaft, then separate functions are provided, but the catheter profile is increased making delivery through smaller vessels difficult
Solution Approach 1:
The inflation lumen and structural core are merged into a single integrated lumen structure. This eliminates the need for separate guidewire and inflation lumens, reducing the catheter profile while maintaining all necessary functions within the single lumen design.
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
Enables navigation through tortuous vasculature without a guidewire, maintaining stiffness and pushability, and accommodating a range of devices, while allowing for effective occlusion and blood flow restoration in smaller vessels.
Implementation Method 1
the balloon is inflated or expanded to dilate the opening thereby restoring blood flow through the vessel
Implementation Method 2
a wire member extending in an axial direction within the compliant balloon, wherein the wire member is secured at a plurality of connection points along the coil assembly
Data Source
AI summary
Balloon catheter devoid of guidewire or guidewire lumen and having a proximal shaft with only a single continuous lumen. A coil assembly is mounted at its proximal end to the distal end of the proximal shaft defining an interface therebetween. Disposed about a distal section of the proximal shaft and a proximal section of the coil assembly is a sleeve. A balloon, having a vent hole, forms a proximal leg seal about an outer surface of a distal end of the sleeve and an opposite distal leg seal. The sleeve covers the interface and extends axially in a distal direction terminating underneath the proximal leg seal of the balloon. A distal section of the coil assembly at least partially coincides with the distal leg seal of the balloon. A wire member secured at a plurality of connection points along the coil assembly extends axially within the balloon.