Balloon Catheter Core Wire Lesion Cracking
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Solution Overview
Problem
Balloon dilatation catheters face challenges in navigating tortuous anatomy and safely crossing tight lesions, particularly bifurcation lesions, due to limited focused force and maneuverability.
Innovation Solution
A device with a main elongated element, a balloon at its distal end, an auxiliary elongated element positioned proximal to the balloon, and a core wire system that includes an internal and external core wire portion, along with a distal connecting element, providing enhanced pushability and maneuverability by allowing the guidewire and balloon to exert focused force on different sides of the lesion.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Force
If a balloon dilatation catheter is used to treat lesions in vessels, then the vessel can be dilated, but the catheter cannot safely cross very tight lesions or navigate tortuous anatomy due to limited focused force
Solution Approach 1:
The catheter system is divided into multiple functional segments: a core wire for navigation and initial force application, a balloon for dilation, and an auxiliary elongated element for additional support and force. This segmentation allows each component to perform its specific function optimally while working together to overcome tight lesions.
Solution Approach 2:
The core wire acts as an intermediary element that provides a trackable path through tortuous anatomy and delivers focused force to the lesion before balloon inflation. The auxiliary elongated element serves as another intermediary providing additional support and force application capability.
2Strength
If high inflation pressure is used to crack difficult lesions, then the lesion can be cracked, but trauma to the vessel increases
Solution Approach 1:
The core wire and auxiliary elongated element are positioned and advance through the lesion before balloon inflation, performing preliminary force application that pre-cracks or softens the lesion. This preliminary action reduces the resistance to balloon expansion, allowing the lesion to be cracked at lower inflation pressures and thereby reducing vessel trauma.
3Adaptability or versatility
If a simple balloon catheter is used, then the device is simple to operate, but it cannot provide enhanced focused force or address bifurcation lesions
Solution Approach 1:
The catheter system is designed with multiple functions integrated into a single device: navigation through tortuous anatomy, crossing tight lesions, addressing bifurcation lesions, and providing enhanced focused force for difficult lesions. The core wire, balloon, and auxiliary elongated element work together to provide these multiple treatment capabilities.
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 device enables effective cracking of difficult lesions at safe inflation pressures with improved maneuverability and pushability, minimizing trauma to the vessel by allowing vessel stretching at a lower strain rate.
Implementation Method 1
inflating the balloon so as to push at least the attached wire and the tracking guidewire against different sides of a lesion in the vessel
Data Source
Figure 1A~1D
Figure 1E
Figure 1F~1G
AI summary
Systems and methods for treating a vessel include devices having a main elongated element with a balloon at its distal end, an auxiliary elongated element wherein a distal end of the auxiliary elongated element is proximal to the balloon, and a core wire having a internal core wire portion and an external core wire portion, wherein the external core wire portion is external to the balloon. In some embodiments, a distal connecting element is attached to the distal end of the balloon. In some embodiments, the distal connecting element is positioned at a rotational distance from the auxiliary elongated element. In some embodiments, the balloon is a fixed wire balloon. Inflation of the balloon causes guidewires positioned within the device and external core wires to be pushed up against the lesion, providing a focused force for cracking the lesion.