Tapered Guide-Wire Dilation Device for Lesion Crossing
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Solution Overview
Problem
Current methods face challenges in widening a channel in a treatment site containing a guide-wire, particularly in cases of chronic total occlusions or heavily calcified stenosis, where balloon angioplasty or stent catheter passage is hindered despite successful guide-wire crossing.
Innovation Solution
A dilation device comprising a tubular metallic shaft covered by a polymer sleeve with a tapered distal tip is advanced over the guide-wire, providing sufficient stiffness for channel dilation while maintaining flexibility to navigate tortuous anatomical structures, and a polymer sleeve that forces away occlusive tissue without cutting or coring.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Strength
If a stiff dilation device is used to provide sufficient column strength for advancing through the channel, then the device can effectively dilate the channel, but the device cannot navigate tortuous anatomical structures
Solution Approach 1:
The dilation device is divided into multiple segments or sections with different stiffness characteristics. The proximal portion has higher stiffness for effective dilation, while the distal portion has lower stiffness for navigating tortuous anatomy. This segmentation allows each portion to perform its specific function optimally.
Solution Approach 2:
Different portions of the dilation device have different mechanical properties tailored to their specific functions. The distal tip is made more flexible to navigate bends, while the proximal shaft maintains higher stiffness for dilation. This local differentiation of material properties resolves the contradiction between overall stiffness and local flexibility.
2Productivity
If a tapered distal tip is used to force away occlusive tissue, then the channel is effectively dilated, but the device requires excessive force for advancement
Solution Approach 1:
The dilation device incorporates a compliant or dynamically adaptable tip that can deform or adjust its shape during advancement. This dynamic behavior allows the tip to progressively force away occlusive tissue rather than requiring excessive force to push through all resistance at once, reducing the peak force required for advancement.
3Strength
If a metal shaft is used to provide structural support, then the device has sufficient strength, but the device lacks the flexibility to conform to vessel geometry
Solution Approach 1:
The dilation device uses composite construction combining metal shaft for structural support with flexible covering or coating for adaptability. The metal core provides necessary strength while the flexible outer layer allows the device to conform to tortuous vessel geometry, resolving the contradiction between strength and flexibility.
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 effectively widens the channel, allowing for easier passage of balloon angioplasty or stent catheters across occlusions or stenoses, reducing the force required for advancement and minimizing tissue damage.
Implementation Method 1
the distal end defining a leading surface that is shaped to force away portions of the lesion surrounding the guide-wire away from the guide-wire as the distal end is advanced over the guide-wire through the lesion
Data Source
AI summary
Devices and methods are disclosed for widening a channel in a treatment site, the channel containing a guide-wire. The channel is widened by advancing an elongated dilation device, which is configured to fit tightly over the guide-wire at the distal tip of the dilation device and to provide a distal dilating surface, over the guide-wire and at least partially through the treatment site. The dilation device comprises a tubular metallic shaft, typically a metal inner tube, for providing sufficient stiffness and column strength for the dilator to be advanced at least partially through the channel, and a flexible sleeve providing a tapered distal tip. The distal end of the dilator defines a leading surface that is shaped to force away portions of a lesion surrounding the guide-wire away from the guide-wire as the distal end is advanced over the guide-wire through the lesion, whereby a channel through the lesion is at least partially dilated.