Flow-Directed Guidewire with Collapsible Sail for Stenosis Crossing
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Solution Overview
Problem
Current guidewires and catheters face challenges in efficiently traversing stenoses in blood vessels, particularly due to the difficulty in locating and entering eccentrically placed openings, which can lead to time-consuming procedures and increased risk of distal embolization.
Innovation Solution
A flexible, collapsible member is mounted on the guidewire or catheter, acting as a sail-like construct that imparts drag forces in the presence of flow to direct the device into areas of maximal flow, allowing it to navigate through stenoses by collapsing to fit through narrow passages and being steerable by external controls.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If traditional guidewires are used to traverse stenoses, then the procedure requires multiple trial and error attempts to locate and enter the eccentric opening, but this increases procedure time and the risk of distal embolization
Solution Approach 1:
The patent replaces manual mechanical manipulation of the guidewire with a flow-directed system. The collapsible member acts as a flow sensor that passively directs the guidewire into the stenosis opening by converting blood flow kinetic energy into directional guidance, eliminating the need for trial-and-error mechanical attempts.
Solution Approach 2:
The guidewire system performs self-guidance through the stenosis by using the collapsible member to sense flow direction and automatically orient itself into the eccentric opening. The system serves its own navigation function without requiring external manual manipulation or multiple attempts.
2Reliability
If multiple attempts are made to traverse the stenosis, then the guidewire may eventually enter the opening, but the risk of distal embolization increases significantly
Solution Approach 1:
The patent replaces repeated mechanical manipulation attempts with a single flow-directed attempt. The collapsible member converts hemodynamic forces into directional guidance, allowing the guidewire to enter the stenosis on the first attempt without requiring multiple manipulations that could dislodge plaque and cause embolization.
Solution Approach 2:
The patent converts the potentially harmful turbulent flow and high velocity blood stream into a beneficial guiding force. The collapsible member captures the kinetic energy of the blood flow and redirects it to push the guidewire into the stenosis opening, transforming the harmful high-velocity flow into a useful guiding mechanism that reduces manipulation-related embolization risk.
3Productivity
If the guidewire tip is made stiffer to penetrate the stenosis opening, then crossing efficiency improves, but trauma to the vessel walls increases
Solution Approach 1:
The patent applies dynamics by making the guidewire tip collapsible rather than rigid. The tip can deform and collapse under flow forces to navigate the stenosis opening, then expand once through to provide structural support. This dynamic transformation allows efficient crossing without the need for a permanently stiff tip that would cause vessel wall trauma.
Solution Approach 2:
The patent changes the physical state of the guidewire tip from rigid to collapsible, allowing it to dynamically adjust its structural properties. The tip can collapse to a smaller profile to pass through the stenosis opening and then expand to provide pushability and support, changing the mechanical parameters of the device to optimize both crossing efficiency and vessel wall protection.
4Object-affected harmful factors
If the guidewire is made more flexible to reduce vessel trauma, then vessel wall protection improves, but the ability to traverse stenoses efficiently decreases
Solution Approach 1:
The patent applies dynamics by making the guidewire tip collapsible rather than rigid. The tip can deform and collapse under flow forces to navigate the stenosis opening, then expand once through to provide structural support. This dynamic transformation allows efficient crossing without the need for a permanently stiff tip that would cause vessel wall trauma.
Solution Approach 2:
The patent replaces manual mechanical manipulation of the guidewire with a flow-directed system. The collapsible member acts as a flow sensor that passively directs the guidewire into the stenosis opening by converting blood flow kinetic energy into directional guidance, eliminating the need for trial-and-error mechanical attempts.
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
This solution enables quicker and more efficient traversal of stenoses with reduced trauma to the vessel walls, minimizing the risk of embolization and improving procedural efficiency by harnessing flow dynamics to guide the device into the desired vessel branch.
Implementation Method 1
when in the expanded position imparts drag forces to the guidewire in the presence of flow
Implementation Method 2
allow it to collapse, deform, fold or otherwise decrease its diameter to allow it to advance through the narrowing or stenosis
Data Source
AI summary
A device for accessing a vessel, duct or lumen, comprising a guidewire having a proximal end and a distal end, and at least one projection that extends from said guidewire at or near the distal end of the guidewire. When the guidewire is placed into the vessel, duct or lumen containing a flowing fluid, the drag on the guidewire is greater when the fluid is flowing from the proximal to distal end of the guidewire than it is when it is flowing distally-to-proximally, thereby helping to direct the guidewire. The device is particularly useful in crossing a narrowing in the vessel, duct or lumen, such as may occur in blood vessels containing a stenosis, such as due to atherosclerosis.