Balloon Catheter Feedback Control for Sinus Dilation

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Solution Overview

Problem

Current balloon catheter methods for dilating sinus ostia lack precise control over inflation parameters, leading to potential under-inflation or over-inflation, which can result in insufficient treatment or ostium fracture, and do not effectively deliver therapeutic agents due to lack of real-time monitoring and feedback.

Innovation Solution

A method involving a balloon catheter system that inserts a catheter with a balloon into a sinus ostium, inflates it while determining parameters like pressure, volume, or diameter, and controls inflation to avoid fracturing the ostium, using a pump with feedback mechanisms to ensure safe and effective dilation and delivery of therapeutic agents.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If balloon catheter inflation is performed without real-time monitoring, then the procedure is simpler and faster, but precise control over inflation parameters cannot be achieved leading to under-inflation or over-inflation

Engineering Contradiction:
Improveinflation parameter controlVSAvoidmonitoring system complexity
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The patent incorporates real-time monitoring of balloon inflation parameters (pressure, volume, diameter) with feedback control mechanisms. The system continuously measures inflation parameters and adjusts the inflation process accordingly, allowing precise control to prevent both under-inflation and over-inflation while maintaining safety throughout the procedure.

Inventive Principle:
Principle #23Feedback

Solution Approach 2:

The patent replaces manual mechanical inflation control with an automated system that uses sensors and control algorithms. This substitution enables precise measurement and control of inflation parameters without requiring complex manual intervention, achieving accurate control while simplifying the overall operation.

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

2Productivity

If high inflation pressure is applied to dilate sinus ostia, then dilation effectiveness is improved, but the risk of ostium fracture increases

Engineering Contradiction:
Improvedilation effectivenessVSAvoidostium fracture risk
Core Design Contradiction:
ProductivityVSObject-affected harmful factors

Solution Approach 1:

The system continuously monitors inflation pressure and other parameters in real-time, providing feedback to control the inflation process. This allows the system to apply sufficient pressure for effective dilation while automatically adjusting to prevent exceeding the threshold that would cause ostium fracture, thus balancing productivity with safety.

Inventive Principle:
Principle #23Feedback

Solution Approach 2:

The patent dynamically adjusts inflation parameters (pressure, volume, rate) based on real-time measurements and the specific characteristics of the sinus ostium being treated. This parameter optimization enables effective dilation while maintaining pressure levels below the fracture threshold, achieving both effectiveness and safety.

Inventive Principle:
Principle #35Parameter changes

3Reliability

If balloon catheter is used without real-time monitoring, then the procedure is more straightforward, but therapeutic agent delivery is not effectively achieved

Engineering Contradiction:
Improvetherapeutic agent delivery effectivenessVSAvoidfeedback control system
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent integrates real-time monitoring of balloon inflation parameters with therapeutic agent delivery capabilities. The feedback control system ensures that the balloon is inflated to the correct parameters for effective agent delivery, while the monitoring and control mechanisms manage the complexity through automated regulation.

Inventive Principle:
Principle #23Feedback

4Productivity

If repeated inflation cycles are performed to achieve adequate dilation, then treatment effectiveness is improved, but procedure time increases

Engineering Contradiction:
Improvetreatment effectivenessVSAvoidprocedure duration
Core Design Contradiction:
ProductivityVSLoss of time

Solution Approach 1:

The real-time monitoring system provides continuous feedback on balloon inflation status and ostial response. This enables the operator to determine the exact moment when adequate dilation is achieved, avoiding unnecessary repeated cycles and reducing procedure time while ensuring treatment effectiveness through precise, data-driven decision-making.

Inventive Principle:
Principle #23Feedback

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 system allows for precise dilation of sinus ostia without fracturing and effective delivery of therapeutic agents, enhancing the safety and reproducibility of the procedure by providing real-time monitoring and control over inflation parameters.

Implementation Method 1

inflating the balloon by supplying fluid thereto such that the balloon exerts a force on the ostial wall

Methodology Applied
Scientific EffectPressure transmission: Pascal's Law

Data Source

PatentUS9238126B2Biofeedback controlled deformation of sinus ostia
Publication Date: 2016.01.19 SANOVAS INTELLECTUAL PROPERTY LLC
  • US9238126B2 patent drawing
  • US9238126B2 patent drawing
  • US9238126B2 patent drawing

AI summary

A method of dilating a paranasal sinus ostium of a patient, which includes inserting a catheter having at least one balloon into a sinus ostium having an ostial wall, inflating the balloon by supplying fluid thereto such that the balloon exerts a force on the ostial wall, determining at least one parameter of the balloon, establishing an amount the balloon can be inflated without fracturing the sinus ostium based at least in part on the determined parameter of the balloon, and dilating the sinus ostium by inflating the balloon to an amount that does not exceed the established amount.