Sinuplasty Balloon Positioning via Sensor-Driven Catheter Control

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Solution Overview

Problem

In sinuplasty procedures, accurately positioning an inflatable balloon within the sinus ostium is challenging due to the lack of direct visualization or internal imaging, often requiring multiple attempts and potentially causing unnecessary pain and damage to the ENT system.

Innovation Solution

A catheter system equipped with a position sensor and a handle-based navigation system, utilizing anatomical images and a processor to estimate and mark the target position, allowing for precise placement of the balloon within the sinus ostium, even without direct visualization.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If traditional balloon positioning methods are used without position sensors, then the device complexity is reduced, but the positioning precision deteriorates

Engineering Contradiction:
Improveballoon positioning precisionVSAvoidcatheter system complexity
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

A position sensor acts as an intermediary measurement device that indirectly determines balloon position by detecting the position of a reference point (such as a marker or catheter tip) and calculating the balloon position relative to this reference point, thereby achieving precise positioning without direct visualization of the balloon itself

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The patent replaces direct mechanical visualization methods with an electronic sensing system that uses position sensors, image processing, and computational algorithms to determine balloon position, substituting mechanical direct observation with an automated sensing and calculation system

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

2Measurement precision

If multiple attempts are made to position the balloon accurately, then the positioning precision is improved, but the procedural time increases

Engineering Contradiction:
Improveballoon positioning precisionVSAvoidprocedural time
Core Design Contradiction:
Measurement precisionVSLoss of time

Solution Approach 1:

The system performs preliminary calculations and estimations of the balloon position based on sensor data and anatomical images before the actual positioning is attempted, allowing the operator to navigate to the correct location more quickly and reducing the number of trial attempts needed

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The position sensor provides real-time feedback on the catheter's position and the balloon's estimated position, allowing the operator to immediately adjust the navigation to achieve accurate positioning in fewer attempts, thereby reducing overall procedural time

Inventive Principle:
Principle #23Feedback

3Reliability

If the balloon is inflated to expand the sinus ostium, then the treatment effectiveness is improved, but the risk of fracturing the sinus ostium increases

Engineering Contradiction:
Improvesinus ostium dilation effectivenessVSAvoidrisk of sinus ostium fracture
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The system performs preliminary assessment of the sinus ostium dimensions using anatomical images and position sensor data before balloon inflation, calculating the safe inflation pressure and volume needed to achieve dilation without exceeding the fracture threshold of the sinus ostium wall

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The position sensor provides real-time feedback on the balloon's position and the force applied during inflation, allowing the operator to monitor the dilation process and stop or adjust inflation immediately if signs of excessive force or risk of fracture are detected

Inventive Principle:
Principle #23Feedback

Data Source

PatentUS11103249B2Balloon positioning in a sinuplasty procedure
Publication Date: 2021.08.31 BIOSENSE WEBSTER (ISRAEL) LTD
  • US11103249B2 patent drawing
  • US11103249B2 patent drawing
  • US11103249B2 patent drawing

AI summary

A method includes inserting into a patient organ a catheter including a position sensor, a device and a handle. The position sensor is attached to a distal end of the catheter. The device is movable along the catheter. The handle includes a control for navigating the device along the catheter to a target location in the patient organ. Based on a location of the position sensor, a target position of the control on the handle that corresponds to the target location of the device is estimated. A marker is set to mark the target position of the control on the handle, and the device is navigated to the target location by setting the control to the marker.