Insufflator Pressure-Volume Control for Safe Cavity Inflation
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Solution Overview
Problem
Current insufflation methods rely on heuristic pressure selection, which can lead to over- or under-inflation of cavities, posing clinical risks and complicating remote minimally invasive procedures by lacking real-time pressure control.
Innovation Solution
An insufflator with integrated pressure and flow sensors, a signal processor to determine the working pressure range by analyzing pressure/volume relationships, and a set-up mode to establish an optimum maximum pressure for safe and effective cavity inflation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If heuristic pressure selection is used for cavity insufflation, then the insufflation process is simple to operate, but the working pressure range cannot be precisely determined leading to over- or under-inflation
Solution Approach 1:
The insufflator performs preliminary determination of the working pressure range by delivering insufflating gas to the cavity and analyzing the pressure/volume relationship before actual surgical insufflation begins. This preliminary action establishes the optimal maximum pressure specific to each patient's cavity compliance, eliminating the need for heuristic pressure selection during surgery.
Solution Approach 2:
The system continuously monitors cavity pressure and insufflating gas delivery, using this feedback to determine the pressure/volume relationship. The signal processor analyzes this real-time data to identify the transition point where cavity expansion becomes non-linear, thereby precisely determining the working pressure range based on actual patient response rather than fixed heuristic values.
2Adaptability or versatility
If fixed insufflating pressure values from literature are used, then the insufflation protocol is easy to follow, but the pressure may be inappropriately high or low for individual subjects
Solution Approach 1:
The system determines a customized working pressure range for each individual subject by measuring their specific cavity compliance characteristics. Instead of applying a universal fixed pressure from literature, the insufflator adapts the pressure parameters to the local conditions of each patient's anatomy, body composition, and cavity elasticity, ensuring optimal and safe insufflation for every individual.
Solution Approach 2:
The insufflator automatically determines the appropriate working pressure range for each subject without requiring manual adjustment by the surgeon. The system self-calibrates by delivering test insufflation, measuring the pressure/volume relationship, and calculating the optimal maximum pressure specific to that patient, thereby eliminating the need for surgeons to manually adapt fixed protocol values.
3Volume of moving object
If high insufflating pressure is applied to achieve adequate working volume in subjects with low cavity compliance, then the working volume is sufficient, but clinical risks such as post operative pain and reduced venous return increase
Solution Approach 1:
The system dynamically determines the optimal maximum pressure by monitoring the real-time pressure/volume relationship during preliminary insufflation. For subjects with low cavity compliance, the system identifies the specific pressure point where further pressure increase yields diminishing volume expansion, thereby establishing a customized maximum pressure that achieves adequate working volume while avoiding excessive pressure that would cause clinical complications.
Solution Approach 2:
The insufflator changes the pressure parameter adaptively based on measured cavity compliance characteristics. By analyzing the slope of the pressure/volume curve and identifying transition points, the system adjusts the maximum pressure parameter to match each patient's physiological characteristics, ensuring sufficient working volume is achieved without exceeding safe pressure thresholds that would cause harm.
4Measurement precision
If cavity pressure is increased beyond the working pressure range, then the cavity is fully expanded, but the pressure/volume relationship becomes non-linear with little gain in working volume
Solution Approach 1:
The system replaces manual mechanical assessment of cavity expansion with electronic pressure and flow sensors that continuously measure the pressure/volume relationship. The signal processor automatically detects the transition from linear to non-linear expansion by analyzing the derivatives of pressure and volume data, precisely identifying when the cavity reaches optimal expansion without requiring excessive gas delivery or pressure increase.
Data Source
AI summary
An insufflator is operable in a set-up mode and in a normal insufflating run mode. In the set-up mode, a pressure/volume relationship between cavity pressure and cavity volume of the cavity of a subject is determined. A minimum safe working pressure value and a maximum safe working pressure value of a working pressure range for the cavity to be insufflated is determined from the pressure/volume relationship as a pressure value just above a lower point of inflection and an upper point of inflection of the pressure/volume relationship, respectively. In the normal insufflating run mode a working pressure value is selected from the range of working pressure values and the insufflator insufflates the cavity to the selected working pressure value. Also disclosed is an insufflating system comprising an insufflator operable in a set-up mode and in a normal insufflating run mode. A controller located remotely relative to the insufflator remotely controls the insufflator to operate in the set-up mode and/or the normal insufflating run mode.