Balloon Catheter Sinus Dilation Device
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Solution Overview
Problem
Current methods for treating chronic sinusitis, such as Balloon Sinuplasty, have limitations in effectively addressing persistent blockages and infections in paranasal sinuses, necessitating improved devices and techniques for sinus drainage and ventilation.
Innovation Solution
A medical device comprising a handle, grooming sheath, rail, guide wire, and balloon catheter with a movement mechanism, allowing for precise advancement and inflation of the balloon catheter within the sinus anatomy to dilate ostia and improve drainage, while being cost-effective and easy to use.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If rigid instruments are used for removing tissue from the nasal cavity and sinus ostia, then sinus drainage is improved, but the procedure becomes more invasive and complex
Solution Approach 1:
The patent replaces rigid mechanical cutting instruments with a compliant balloon catheter that uses controlled expansion to dilate sinus ostia. The balloon catheter advances through a flexible delivery system and expands within the sinus opening to mechanically dilate the passage without requiring rigid cutting tools or extensive surgical instrumentation.
Solution Approach 2:
The patent employs a compliant balloon catheter with a flexible delivery system that can navigate the nasal cavity and sinus anatomy. The balloon catheter uses a flexible shaft and compliant balloon element that can be advanced through tortuous pathways and expanded at the target sinus ostium to create drainage passages without rigid structural support.
2Reliability
If traditional surgical procedures are performed to improve sinus drainage, then drainage is enhanced, but patient recovery time and procedure duration increase
Solution Approach 1:
The patent replaces traditional surgical tissue removal and bone drilling with balloon catheter expansion. The compliant balloon catheter dilates the sinus ostium by controlled expansion, achieving drainage enhancement in a single procedural step without requiring multiple surgical interventions or extended recovery periods.
Solution Approach 2:
The patent changes the physical state and dimensions of the balloon catheter during the procedure. The balloon is delivered in a compressed, low-profile state through the nasal cavity, then expanded to a larger diameter at the sinus ostium to achieve dilation. This parameter change allows the same device to perform both delivery and treatment functions efficiently.
3Reliability
If multiple pathogen infections in chronic sinusitis are treated with multiple drugs, then infection coverage is improved, but treatment complexity and cost increase
Solution Approach 1:
The patent describes a single multi-functional device that can treat multiple sinus ostia and address various aspects of sinusitis. The compliant balloon catheter system can be used to dilate multiple sinus passages (frontal, maxillary, sphenoid) and can be combined with irrigation or medication delivery through the same access route, reducing the need for multiple separate treatments.
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 device efficiently treats sinus openings by providing improved drainage and ventilation, reducing the need for invasive procedures and offering a cost-effective solution for sinus treatment, with potential applications beyond sinusitis.
Implementation Method 1
a balloon catheter... allowing for precise advancement and inflation of the balloon catheter within the sinus anatomy to dilate ostia
Data Source
AI summary
A medical device for the treatment of a sinus opening includes a handle, a grooming sheath, a rail, a guide wire, a balloon catheter and a balloon catheter movement mechanism. The handle has a proximal end, a distal end and a longitudinal axis along the length of the handle. The grooming sheath has a distal end and a proximal end with the proximal end of the grooming sheath being attached to the distal end of the handle. The rail has a distal end and a proximal end and disposed partially within the grooming sheath to define an annular lumen is between the rail and the grooming sheath. The guide wire operatively extends from the distal end of the rail and the balloon catheter is disposed at least partially in the handle and annular lumen. The balloon catheter movement mechanism operatively disposed on the handle and configured for advancement and retraction of the balloon catheter through both the handle and the annular lumen and along both the rail and guide wire by user operation of the balloon catheter movement mechanism. A method for treating a sinus opening includes inserting a medical device for the treatment of a sinus opening partially into a patient's anatomy and then positioning a guide wire operatively extending from a rail of a medical device into a sinus opening of the patient. The method further includes advancing a balloon catheter from an annular lumen of the medical device and along both the rail of the medical device and the guide wire. The method also includes treating the sinus opening via inflation of the balloon catheter. In the method, the annular lumen is between the rail and a grooming sheath of the medical device and the advancing is accomplished via user operation of a balloon catheter movement mechanism of the medical device.