Sinus Dilation Catheter with Illuminated Guidewire
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Solution Overview
Problem
Current methods for dilating anatomical passageways, such as those in the sinuses, often require invasive procedures like ethmoidectomy, which can cause damage and are not elegant solutions for improving fluid communication without removing significant mucosa or bone, and there is a need for more precise visualization and positioning of dilation tools.
Innovation Solution
A dilation catheter system comprising an inflatable dilator, a guidewire with illumination for external visualization, and a variable direction endoscope for precise positioning and dilation of anatomical passageways without invasive procedures, allowing for controlled expansion and visualization within the anatomical structures.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If traditional invasive procedures like ethmoidectomy are used to improve fluid communication in sinuses, then drainage and ventilation are improved, but damage to surrounding tissues and removal of significant mucosa or bone occurs
Solution Approach 1:
The invention extracts only the necessary portion of bone (anterior ethmoidal wall) to create a small opening, rather than removing significant bone or mucosa as in traditional ethmoidectomy. The drill creates a precise, minimal opening that allows balloon catheter passage while preserving surrounding healthy tissue structures.
Solution Approach 2:
The invention introduces a balloon catheter as an intermediary device that can be passed through the small drilled opening in the ethmoidal wall. This intermediary allows access to the sinus cavity and enables dilation of sinus ostia without requiring direct invasive access or removal of significant tissue.
2Reliability
If invasive procedures are performed to dilate sinus passageways, then anatomical opening is created, but precision in positioning and visualization is reduced
Solution Approach 1:
The invention incorporates feedback mechanisms including fluoroscopic imaging and contrast material injection that allow real-time visualization and confirmation of catheter positioning. The operator can see the catheter tip location and adjust positioning before inflating the balloon, ensuring precise placement at the target sinus ostium.
Solution Approach 2:
The invention replaces traditional mechanical exploration and positioning methods with imaging-based guidance systems. Instead of relying on anatomical landmarks and tactile feedback alone, fluoroscopy and contrast material provide visual feedback that substitutes for mechanical positioning uncertainty.
3Object-affected harmful factors
If minimal invasive approach is used for sinus dilation, then tissue preservation is improved, but ability to create sufficient opening for drainage is reduced
Solution Approach 1:
The invention uses a dynamic, two-stage approach: first creating a small static opening in the ethmoidal wall, then using the dynamic expansion of an inflatable balloon catheter to create the final drainage opening. The balloon can be inflated to various sizes to ensure adequate ostium dilation while the initial access opening remains minimal, thus preserving surrounding tissue.
Solution Approach 2:
The invention changes the physical state and dimensions of the opening dynamically. The balloon catheter is inserted in a collapsed state through a small opening, then inflated to expand the ostium to the required size for drainage. This parameter change allows the opening to transition from minimal (for access) to sufficient (for drainage) without requiring the initial opening to be large.
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 precise and minimally invasive dilation of anatomical passageways, improving fluid communication and reducing the risk of damage to surrounding tissues, with the ability to visualize the positioning of dilation tools externally, thus providing a more elegant and effective treatment option.
Implementation Method 1
an illuminating guidewire. Such a guidewire may be positioned within the target area and then illuminated, with light projecting from the distal end of the guidewire
Implementation Method 2
an inflatable balloon within the anatomical passageway, then inflating the balloon with a fluid (e.g., saline) to dilate the anatomical passageway... The expandable balloon may be positioned within an ostium at a paranasal sinus and then be inflated, to thereby dilate the ostium by remodeling the bone adjacent to the ostium
Data Source
AI summary
An instrument comprises a shaft assembly. The shaft assembly comprises a first shaft member including a distal cutting feature, and a second shaft member. The first shaft member is slidable relative to the second shaft member. At least a distal portion of the shaft assembly is sized to fit through a nostril. The instrument further comprises a body. At least a portion of the shaft assembly extends distally relative to the body. The body comprises a grounding feature sized and positioned to engage one or more external anatomical structures adjacent to the nostril. The instrument further comprises a dampener. The dampener resists advancement of the first shaft member relative to the second shaft member.