Forward Looking Imaging Guidewire for Narrow Vasculature
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Solution Overview
Problem
Conventional medical imaging systems face challenges in imaging within narrow vasculature due to the risk of blood vessel injury, particularly in weakened or diseased states, where advancing catheters increases the risk of injury or rupture.
Innovation Solution
A guidewire with a forward-looking imaging capability, featuring a flexible distal region and an imaging device within its inner lumen, allowing for imaging of regions distal to the guidewire, which can be coupled with a sonolucent end section for ultrasound imaging, and optionally providing side-looking capabilities, enabling safer navigation and characterization of areas of interest.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If a catheter is advanced into proximity with diseased tissue for imaging, then imaging capability is improved, but the risk of blood vessel injury increases
Solution Approach 1:
The system divides the imaging function between two separate components: a guidewire with forward-looking imaging capability that can safely navigate to the area of interest, and a catheter that remains outside the vessel for backup imaging. This segmentation allows the imaging function to be performed by the smaller, safer guidewire while the catheter serves as a backup, resolving the contradiction between imaging capability and injury risk.
Solution Approach 2:
The forward-looking imaging device on the guidewire performs preliminary imaging of the area of interest before the catheter is advanced. This preliminary action allows the operator to identify and characterize diseased tissue without exposing the vessel to the risks of catheter manipulation, thereby improving imaging capability while minimizing injury risk.
2Ease of operation
If a catheter is advanced into narrow vasculature, then access to area of interest is improved, but the risk of vessel rupture increases
Solution Approach 1:
The system separates the navigation function (performed by the flexible guidewire) from the backup imaging function (performed by the catheter). The guidewire's small profile and flexibility allow safe navigation through narrow vasculature, while the catheter remains as a backup option, resolving the contradiction between access capability and rupture risk.
Solution Approach 2:
The guidewire acts as an intermediary device that can safely navigate narrow vasculature to deliver forward-looking imaging capability to the area of interest. This intermediary approach allows access to diseased tissue without requiring the larger, less flexible catheter to navigate the narrow vessel, thereby improving access while reducing rupture risk.
3Ease of operation
If the guidewire diameter is reduced to 0.025 inches or less, then maneuverability in narrow vasculature is improved, but imaging device integration becomes more difficult
Solution Approach 1:
The imaging device is nested within the lumen of the thin guidewire, with the transducer and associated components housed inside the 0.025-inch diameter structure. This nesting approach allows the imaging functionality to be integrated into the constrained space of the thin guidewire, resolving the contradiction between maneuverability and integration difficulty.
Solution Approach 2:
The guidewire employs flexible construction with thin-walled sections to accommodate the imaging device while maintaining a small overall diameter of 0.025 inches or less. The flexible structure allows the imaging components to be integrated without compromising the guidewire's ability to navigate narrow vasculature, resolving the contradiction between thin profile and device integration.
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 guidewire enables safer imaging and characterization of blood vessel interiors, reducing the risk of injury by allowing precise localization and characterization of diseased tissues, facilitating the selection and administration of appropriate interventional therapies while maintaining maneuverability within constricting vasculature.
Implementation Method 1
The adhesive and sonolucent end section can each be separately configured as matching layers for the imaging device, for use with imaging techniques which are amenable to matching layers, such as ultrasound imaging
Data Source
AI summary
The systems and methods described herein provide for a forward looking guidewire having a reduced radial cross-section for increased maneuverability and use of the guidewire within more narrow vasculature. The guidewire can include an elongate tubular member having a distal region, proximal region and inner lumen and a forward looking imaging device coupled with the distal end of the guidewire. The distal region of the guidewire can be relatively more flexible than the proximal region. The guidewire can also include a second, side looking imaging device, which can be coupled around a longitudinal portion of the guidewire in the radial or proximal regions.