Shapeable Distal Portion for Intravascular Re-Entry
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Solution Overview
Problem
Current methods for crossing chronic total occlusions (CTOs) in blood vessels are challenging due to the difficulty in navigating guidewires through or around the occlusions, often resulting in complications such as vessel perforation and dissection, and require larger re-entry devices that increase procedure time and x-ray exposure.
Innovation Solution
The development of intravascular devices with shapeable distal portions that can be angled or shaped during procedures to facilitate navigation through tortuous vasculature, allowing for precise re-entry into the true lumen without the need for large re-entry devices, using materials like Nitinol and stainless steel, and featuring a rotating member and lubricious coatings for smooth manipulation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional re-entry devices are used to cross CTOs, then the devices can penetrate the occlusion, but they create large holes and flaps in the vessel wall causing complications such as perforation and dissection
Solution Approach 1:
The device employs a tapered re-entry portion with progressively decreasing diameter from proximal to distal end, creating a localized cutting action that progressively divides the vessel wall layers. This local quality variation allows controlled penetration without creating large holes, reducing the risk of perforation and dissection while maintaining vessel wall integrity.
Solution Approach 2:
The re-entry portion is segmented into multiple functional zones: a cutting edge for initial penetration, a tapered section for progressive division of wall layers, and a proximal transition zone. This segmentation allows the device to systematically address different layers of the vessel wall in a controlled manner, minimizing harmful effects.
2Productivity
If larger re-entry devices are used to ensure successful crossing, then the crossing ability is improved, but the procedure time and x-ray exposure increase significantly
Solution Approach 1:
The device features a shapeable distal portion that can be dynamically angled during the procedure to optimize its path through the occlusion. The distal tip can be positioned at various angles (e.g., 0-90 degrees) to navigate tortuous anatomy, allowing the use of smaller, less time-consuming devices while maintaining effective crossing capability.
Solution Approach 2:
The device allows change in geometric parameters (angle, shape) of the distal portion during the procedure. By adjusting these parameters, the device can adapt to different anatomical configurations, achieving successful crossing without requiring larger device sizes that would increase procedure time and radiation exposure.
3Stability of the object's composition
If the distal portion is made rigid to maintain shape, then the structural stability is improved, but the ability to navigate tortuous vasculature is reduced
Solution Approach 1:
The distal portion is designed with dynamic shapeability, allowing it to be manipulated into different angular configurations during navigation. The material and structure enable the distal tip to be angled at various degrees to navigate tortuous vasculature, while still maintaining sufficient rigidity to perform the re-entry function once positioned.
Solution Approach 2:
The device features an asymmetric distal portion with specific angular configurations that can be deliberately created during manufacturing or manipulation. This asymmetry allows the distal tip to engage with the vessel wall at optimal angles for both navigation and re-entry, balancing shape retention with navigation capability.
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 safer and more efficient crossing of CTOs by reducing the risk of complications and minimizing procedure time and x-ray exposure, while maintaining a low profile and maximizing crossing ability.
Implementation Method 1
the distal portion can be made from a shape memory alloy or other shapeable material
Implementation Method 2
featuring a rotating member and lubricious coatings for smooth manipulation
Data Source
Figure 1A~1C
Figure 1D~1E
Figure 1F
AI summary
Methods for treating a patient using intravascular devices, systems, and methods are disclosed herein. One aspect of the present technology is directed to an intravascular device having an elongated member coupled to and extending between a handle and an angled distal portion. The distal portion is moveable between a first configuration having a first shape configured for intravascular delivery and a second configuration having a second shape, different than the first shape, that is configured for intravascular delivery.