Balloon Catheter Core Wire Configuration for Lesion Cracking
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Solution Overview
Problem
Balloon dilatation catheters face difficulties in navigating tortuous anatomy and safely crossing very tight lesions, especially bifurcation lesions, due to limited focused force and maneuverability.
Innovation Solution
A balloon dilatation catheter system with a main elongated element, an auxiliary elongated element, and a core wire configuration that provides enhanced pushability and maneuverability, featuring a distal connecting element and occlusion balloon to apply focused force alongside the balloon, allowing for improved navigation and treatment of lesions.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Force
If a balloon dilatation catheter is used to treat lesions in vessels, then the lesion can be dilated, but the system provides limited focused force and cannot safely cross very tight lesions
Solution Approach 1:
The catheter system is divided into multiple functional segments: a main elongated element for navigation, an auxiliary elongated element for support, a core wire for pushability, and a balloon for dilation. This segmentation allows each component to perform its specific function optimally, with the core wire providing focused force through tight lesions while the balloon performs dilation.
Solution Approach 2:
The auxiliary elongated element is positioned within the main elongated element, and the core wire runs through both elements. This nested configuration allows the components to work together in a compact structure while maintaining the ability to deliver focused force through the lesion site without excessive external profile.
2Ease of operation
If a balloon dilatation catheter is used to treat lesions, then dilation can be achieved, but the system lacks pushability and maneuverability in tortuous anatomy
Solution Approach 1:
The catheter system has different mechanical properties at different locations. The core wire provides high pushability and rigidity at the distal end where force is needed to cross lesions, while the proximal portions maintain flexibility for navigation through tortuous vessels. The auxiliary element within the main element creates a gradient of mechanical properties along the catheter length.
3Force
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 acts as an intermediary element that concentrates and directs force precisely at the lesion site through the balloon. This allows the operator to apply focused force to crack the lesion while the balloon itself remains inflated at lower pressures, reducing the risk of vessel trauma compared to direct high-pressure balloon inflation.
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 system enables effective cracking of difficult lesions with reduced trauma by applying focused force at lower inflation pressures, improving navigation through tortuous vessels and bifurcations, and facilitating precise positioning and treatment.
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
AI summary
A device for introduction into a vessel including a main elongated element having a main elongated element proximal end and a main elongated element distal end, a balloon positioned at the main elongated element distal end, and a core wire attached to the device at a core wire attachment point and including an internal core wire portion positioned in the main elongated element and an external core wire portion positioned distally with respect to the internal core wire portion and positioned in parallel relation and external to the balloon.