Rigid-Guide Balloon Catheter for Constricted Sinus Pathways
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Solution Overview
Problem
Sinusitis, particularly chronic and recurrent sinusitis, is often resistant to medical therapy due to obstructed sinus cavities, leading to inflammation and infection, and existing balloon dilation devices face challenges in effectively treating constricted sinus passageways.
Innovation Solution
A balloon dilation catheter with a rigid inner guide member and a movable shaft, allowing the balloon to be advanced and inflated within the sinus drainage pathway to remodel and expand the passageway, optionally assisted by a light source for visualization.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If a conventional balloon catheter is used for sinus dilation, then the device can be inserted through the nasal passageway, but the balloon cannot be reliably positioned or tracked within the constricted sinus passageway
Solution Approach 1:
A radiopaque guide wire is introduced as an intermediary element within the catheter assembly. The guide wire serves as a radiopaque track that allows real-time visualization and tracking of the catheter's position within the sinus passageway during fluoroscopic guidance, enabling precise balloon positioning without requiring complex external tracking systems
Solution Approach 2:
The catheter is divided into distinct functional segments: a flexible catheter shaft for navigation, a radiopaque guide wire for tracking, and an inflatable balloon for dilation. This segmentation allows each component to perform its specific function independently, with the guide wire providing positional information while the balloon executes the dilation action
2Reliability
If the sinus drainage pathway is constricted due to inflammation, then medical therapy may be attempted, but chronic and recurrent sinusitis persists despite appropriate medicates
Solution Approach 1:
The procedure performs preliminary mechanical dilation of the constricted sinus drainage pathway before the natural healing process can occur. By physically expanding the blocked passage using an inflatable balloon under fluoroscopic guidance, the treatment creates immediate improvement in drainage function that precedes and enhances the effect of subsequent medical therapy
Solution Approach 2:
The invention replaces continued reliance on medical therapy (pharmacological treatment) with a mechanical intervention system. The inflatable balloon catheter provides direct mechanical dilation of the blocked passage, substituting the need for prolonged or repeated medicate treatment with a single procedural intervention that physically restores drainage function
3Productivity
If the balloon is inflated to expand the drainage pathway, then sinus ventilation improves, but the procedure requires fluoroscopic guidance and specialized equipment
Solution Approach 1:
The radiopaque guide wire acts as an intermediary that bridges the gap between the flexible catheter and the fluoroscopic imaging system. The guide wire's radiopaque material makes it visible on fluoroscopic images, allowing real-time tracking and control of the catheter's position and orientation during the dilation procedure
Solution Approach 2:
The invention replaces complex endoscopic visualization systems with a simpler fluoroscopic guidance approach. By using radiopaque materials that are visible on fluoroscopic images, the system achieves real-time tracking of the catheter without requiring complex endoscopic instruments or sophisticated image processing systems
Data Source
AI summary
A method of treating a sinus cavity of a subject includes advancing a distal portion of a light source through a drainage pathway of a sinus cavity and into the sinus cavity and visually observing a transdermal light emitted from the light source. A distal portion of a substantially rigid inner guide member of a balloon dilation catheter is advanced into the drainage pathway, the balloon dilation catheter including a movable shaft including a balloon that is slidably mounted on the substantially rigid inner guide member. The movable shaft and balloon are advanced distally over the substantially rigid inner guide member to place a portion of the balloon in the drainage pathway whereby the balloon is inflated.