Intertwined Core Wire Guidewire for Precise Balloon Placement
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Solution Overview
Problem
Existing methods for dilating anatomical passageways, such as paranasal sinuses, lack precise visualization and navigation, especially when normal anatomical landmarks are difficult to visualize endoscopically, and there is a need for improved positioning of balloons during procedures like balloon sinuplasty.
Innovation Solution
A guidewire assembly with an integrated illumination feature and an image-guided surgery (IGS) system, allowing for real-time 3D navigation and visualization, combined with a dilation catheter system for precise balloon placement and inflation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If traditional endoscopic visualization is used to position the balloon, then the procedure can be performed with simpler equipment, but precise visualization and navigation are lacking when normal anatomical landmarks are difficult to visualize
Solution Approach 1:
The patent combines multiple guidance systems (endoscopic visualization, illumination guidewire, and image-guided surgery navigation) into a single integrated system. The guidewire assembly integrates illumination fibers and electromagnetic sensors, while the system merges real-time endoscopic views with preoperative 3D anatomical models, allowing precise visualization without requiring complex separate devices for each function.
Solution Approach 2:
The patent introduces an illumination guidewire as an intermediary tool that provides visual confirmation of guidewire placement through transcutaneous light transmission. This intermediary device bridges the gap between the operator and the deep anatomical structures, allowing visualization of guidewire position without directly viewing the target area, thereby improving measurement precision without proportionally increasing system complexity.
2Measurement precision
If an illuminating guidewire is used to provide visual confirmation of guidewire placement, then positioning accuracy is improved, but the device complexity increases
Solution Approach 1:
The guidewire is designed with multi-functionality, serving both as a navigation tool and an illumination source. The guidewire incorporates optical fibers for illumination, electromagnetic sensors for image-guided navigation, and structural features for mechanical guidance. This universal design allows a single device to perform multiple functions that would otherwise require separate tools, improving placement precision without proportionally increasing overall system complexity.
3Manufacturing precision
If image-guided surgery system is used for real-time 3D navigation, then balloon placement precision is enhanced, but the device complexity and cost increase
Solution Approach 1:
The image-guided surgery system utilizes preoperatively obtained 3D anatomical images (CT or MRI scans) that are converted into digital maps before the procedure. This preliminary preparation allows the system to provide real-time navigation based on pre-planned anatomical pathways, reducing the complexity of real-time decision-making during the procedure while maintaining high placement precision.
Solution Approach 2:
The system incorporates real-time feedback through electromagnetic sensors on the guidewire that continuously track the position of surgical instruments relative to the preoperative 3D anatomical model. This feedback loop allows the operator to see the current instrument position overlaid on the anatomical model, enabling precise balloon placement while the system manages the complexity through automated tracking and display.
4Measurement precision
If multiple guidance systems are integrated into a single system, then overall procedure precision is improved, but the device complexity increases significantly
Solution Approach 1:
The patent merges multiple guidance systems (endoscopic visualization, illumination guidewire with optical fibers, and image-guided surgery navigation with electromagnetic sensors) into a single integrated system. The guidewire assembly itself combines illumination fibers, electromagnetic sensors, and structural features, while the control system integrates real-time endoscopic views with preoperative 3D anatomical models, allowing precise visualization and navigation without requiring complex separate devices for each function.
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
Enhances the precision and safety of balloon dilation procedures by providing real-time 3D navigation and visual confirmation of guidewire placement, ensuring accurate positioning and inflation of balloons within anatomical passageways.
Implementation Method 1
an illumination fiber optically coupled to the light source and extending along an interior surface of the core wire to a distal end of the guidewire, wherein the illumination fiber is configured to project light outward at the distal end of the guidewire
Implementation Method 2
This light may illuminate the adjacent tissue (e.g., hypodermis, subdermis, etc.) and thus be visible to the naked eye from outside the patient through transcutaneous illumination
Data Source
AI summary
An apparatus and method of manufacture includes a helical wire coil and a core wire. The core wire has a first wire portion and a second wire portion. The first wire portion of the core wire extends through the helical wire coil. The second wire portion of the core wire is intertwined with the first helical wire coil to fixedly secure the core wire relative to the first helical wire coil. The core wire is formed from a first material that is non-extensible. The core wire is fixedly secured relative to a distal portion of the helical wire coil such that the core wire inhibits longitudinal elongation of the helical wire coil along a longitudinal coil axis.