Balloon Dilation Catheter for Sinus Ostium Expansion

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Solution Overview

Problem

Current treatments for sinusitis, such as functional endoscopic sinus surgery, are invasive and can cause significant pain, bleeding complications, and scarring, making them unsuitable for all patients, particularly those with mild or recurrent sinusitis, and there is a need for less invasive methods to address sinusitis effectively.

Innovation Solution

A method and system involving a cannula with lumens for a balloon dilation catheter and visualization tool to create an artificial access passageway into sinus cavities, allowing for balloon dilation to improve drainage without the need for extensive surgical intervention.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If functional endoscopic sinus surgery (FESS) is performed to treat sinusitis, then sinus drainage is improved, but patient pain and tissue trauma increase significantly

Engineering Contradiction:

Improvesinus drainage improvementVSAvoidpatient pain and tissue trauma

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent changes the physical parameters of the dilation method by using a balloon catheter that can be inflated to controlled sizes (e.g., 3-10 mm diameter) to gradually widen the sinus ostia without the need for cutting instruments. This parameter-based approach (controlled expansion rather than surgical resection) reduces tissue trauma while maintaining drainage improvement.

Inventive Principle:

Principle #35Parameter changes

Solution Approach 2:

The patent replaces the mechanical cutting system (surgical instruments, endoscopes, and cutting tools used in FESS) with a balloon dilation system that uses controlled expansion forces. This substitution eliminates the need for tissue resection and reduces mechanical trauma to the sinus structures while achieving the same functional outcome of improved drainage.

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

2Reliability

If FESS surgery is performed to widen sinus ostia, then sinus drainage improves, but scarring and re-obstruction risk increase

Engineering Contradiction:

Improvesinus drainage improvementVSAvoidscar tissue growth and re-obstruction

Core Design Contradiction:

ReliabilityVSObject-generated harmful factors

Solution Approach 1:

The patent replaces the mechanical cutting and resection system with a balloon dilation system that expands tissue rather than removing it. This substitution minimizes the creation of raw surfaces that would otherwise heal by forming scar tissue, thereby reducing the risk of re-obstruction while maintaining drainage improvement.

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

Solution Approach 2:

The patent uses controlled expansion parameters (gradual inflation to specific diameters, controlled duration of dilation) to widen the ostia without causing excessive tissue damage. This parameter control allows the tissue to heal with minimal scarring compared to surgical resection, reducing the risk of future re-obstruction.

Inventive Principle:

Principle #35Parameter changes

3Object-affected harmful factors

If balloon dilation is used to treat sinusitis, then invasiveness is reduced, but the ability to visualize and precisely access sinus ostia is limited

Engineering Contradiction:

Improveinvasiveness reductionVSAvoidvisualization and access precision

Core Design Contradiction:

Object-affected harmful factorsVSDifficulty of detecting and measuring

Solution Approach 1:

The patent combines multiple functions into a single integrated system: the balloon catheter serves both as a visualization guide (with its radiopaque or visible components) and as the dilation instrument. This multi-functionality allows precise access and visualization while maintaining the less invasive nature of the procedure.

Inventive Principle:

Principle #6Universality (Multi-functionality)

Solution Approach 2:

The patent uses the balloon catheter itself as an intermediary tool that provides both visual guidance and dilation capability. The catheter's structure (with visible markers or radiopaque elements) acts as a mediator between the operator and the deep sinus structures, enabling precise positioning without requiring separate visualization instruments.

Inventive Principle:

Principle #24Intermediary (Mediator)

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

This approach provides a less invasive means to treat sinusitis by creating an artificial access passageway for balloon dilation, potentially reducing pain, scarring, and complications, while effectively improving sinus drainage and reducing the need for invasive surgery.

Implementation Method 1

a balloon dilation catheter having an expandable balloon on a distal region

Methodology Applied

Scientific EffectBalloon dilation: Elasticity

Data Source

PatentUS8915938B2Apparatus and method for treatment of sinusitis

Publication Date: 2014.12.23 STRYKER CORP

AI summary

A method of treating a constricted sinus passageway of a patient includes traversing the canine fossa region of the patient so as to form a passageway in the sinus cavity. A cannula is positioned in the passageway. A visualization tool such as an endoscope is passed through a lumen or channel in the cannula to aid in visualization of the anatomical site of interest. A balloon dilation catheter is then deployed through or along the cannula so as to place the balloon within or across the constricted anatomical space (e.g., ostium). The balloon is then expanded so as to expand at least a portion of the constricted anatomical space. Alternative embodiments include the use of an optional guide wire and incorporating a endoscope lumen through the balloon dilation catheter.