Variable Stiffness Chronic Total Occlusion Device
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Solution Overview
Problem
Guidewires face challenges in navigating through chronic total occlusions due to lack of sufficient support, which hinders the success of intravascular procedures like PTCA and PTA.
Innovation Solution
A chronic total occlusion device is designed to provide support to guidewires by incorporating an outer and inner tubular member with a stiffening member, expandable regions, and a marker band, allowing for adjustable stiffness and vessel dilation, enabling the guidewire to pass through occlusions.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If the guidewire is made flexible to conform to tortuous vascular system, then it can navigate through vessels, but it lacks sufficient support to pass through chronic total occlusion
Solution Approach 1:
The guidewire is nested within the inner tubular member, which is itself nested within the outer tubular member. This nested structure allows the guidewire to maintain its flexibility for navigating tortuous vessels while receiving support from the tubular members to traverse chronic total occlusions.
Solution Approach 2:
The tubular members act as intermediaries between the flexible guidewire and the chronic total occlusion. They provide the necessary support structure to enable the guidewire to pass through the occlusion while maintaining its flexibility for subsequent navigation.
2Strength
If the guidewire is made stiff to pass through chronic total occlusion, then it gains support, but it cannot conform to tortuous vascular system
Solution Approach 1:
The device is segmented into multiple functional components: the flexible guidewire for navigation, the inner tubular member for support, and the outer tubular member for protection and positioning. Each segment performs its specific function, allowing the system to achieve both flexibility and stiffness where needed.
Solution Approach 2:
Different parts of the device have different mechanical properties. The guidewire is flexible for conforming to tortuous vessels, while the tubular members provide localized stiffness for traversing chronic total occlusions. This local differentiation of mechanical properties resolves the contradiction between overall flexibility and localized support.
3Strength
If a rigid structure is used to provide support through chronic total occlusion, then stiffness is achieved, but the device cannot be adjusted for different vascular conditions
Solution Approach 1:
The device transitions from a static rigid structure to a dynamic adjustable structure. The stiffening member can be moved along the tubular members, and the expandable region can be inflated or deflated, allowing the device to adapt its stiffness and volume to different vascular conditions and occlusion characteristics.
Solution Approach 2:
The device allows change in key parameters: the position of the stiffening member along the tubular members, the volume of the expandable region, and potentially the material properties. These parameter changes enable adjustment of device stiffness and support characteristics to match different patient-specific vascular conditions.
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 enhances the ability of guidewires to traverse chronic total occlusions by providing necessary stiffness and dilation, facilitating successful vascular procedures such as PTCA and PTA.
Implementation Method 1
The expandable region may further comprise a first region and a second region. The first region may include a first outside diameter. The second region may include a second outside diameter that, when expanded, is generally smaller than the outside diameter of a typical angioplasty balloon.
Implementation Method 2
A stiffening member may be disposed within the annular space. The stiffening member may comprise a distal head and a proximal tail.
Data Source
AI summary
The present invention relates generally to a device for adding stiffening support to a guidewire so as to enable the guidewire or device to pass through a chronic total occlusion. A method for passing a guidewire through a chronic total occlusion is also disclosed.