Nasal Sinus Mapping Probe for Balloon Dilation Measurement
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Solution Overview
Problem
Current methods for assessing the success of balloon sinuplasty procedures require expensive and radiation-exposing fluoroscopic CT scans to measure sinus openings before and after dilation, lacking a non-ionizing alternative for quantifiable measurements.
Innovation Solution
A system with a probe, location sensor, and processor that generates maps of the nasal sinus before and after balloon inflation, allowing for numerical measurement of sinus opening enlargement without ionizing radiation, using magnetic field generators and a sinuplasty balloon to dilate and deflate within the nasal sinus.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If fluoroscopic CT scans are used to measure sinus openings before and after dilation, then measurement precision is improved, but the patient is exposed to ionizing radiation and the cost increases
Solution Approach 1:
The patent replaces the fluoroscopic CT scanning system with a mechanical mapping system that uses a catheter-based sensor to physically trace and map the sinus passage geometry. The sensor collects spatial coordinates along the sinus passage, creating a 3D representation that can be used to measure opening size without ionizing radiation.
Solution Approach 2:
The patent introduces a mapping sensor as an intermediary device that is inserted into the sinus passage to directly measure its geometry. This sensor acts as a mediator between the sinus structure and the measurement system, allowing for direct physical measurement rather than indirect imaging through radiation.
2Measurement precision
If fluoroscopic CT scans are used to measure sinus openings, then measurement precision is improved, but the procedure cost increases
Solution Approach 1:
The patent employs a disposable catheter-based mapping sensor that can be inserted, used for mapping, and then discarded. This single-use approach eliminates the need for expensive reusable imaging equipment and reduces overall procedure costs while maintaining measurement precision.
3Area of moving object
If a balloon is inflated to dilate the sinus opening, then the opening size is enlarged, but the surrounding tissue may be damaged
Solution Approach 1:
The patent uses a dynamic inflation process where the balloon is gradually inflated to the required size rather than sudden full inflation. This controlled dynamic approach allows the tissue to adapt progressively, reducing the risk of sudden rupture or damage while achieving the necessary opening enlargement.
Solution Approach 2:
The mapping sensor provides real-time feedback on the sinus passage dimensions and tissue response during balloon inflation. This feedback mechanism allows the operator to monitor the dilation process and stop inflation when the desired opening size is achieved or when tissue resistance increases, preventing over-dilation and tissue damage.
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
Enables non-ionizing, quantifiable measurement of sinus opening enlargement, providing physicians with a numerical value of the procedure's effectiveness while avoiding the need for costly and radiative scans.
Implementation Method 1
magnetic field generators fixedly positioned in proximity to the nasal sinus, wherein the location sensor generates the first and second signals in response to magnetic fields from the generators traversing the sensor
Data Source
AI summary
Apparatus, including a probe having a distal end insertable into a nasal sinus of a human patient, and a location sensor positioned within the distal end. A sinuplasty balloon is positioned on the distal end at a selected opening of the nasal sinus. A processor receives first signals from the location sensor while the distal end is inserted into the nasal sinus and prior to positioning of the balloon at the selected opening, and generates a first map of the sinus. The processor inflates the balloon when it is at the selected opening, so as to enlarge the selected opening, and subsequently deflates the balloon. The processor then receives second signals from the location sensor and generates therefrom a second map of the sinus. The processor registers the first map with the second map and generates from the registered maps a numerical increase in size of the selected opening.