Standardized Fluid Bed Meal with 13C Marker for Gastric Emptying
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Solution Overview
Problem
Current methods for measuring gastric emptying, such as quantitative gastric scintigraphy, involve the use of radioisotopes, are cumbersome, and lack standardization, making them unsuitable for widespread use, especially in populations like women of childbearing age and children, and are prone to errors due to varying cooking parameters and food quality.
Innovation Solution
A fluid bed processing method is used to create a standardized edible food meal labeled with a marker, like 13C-labeled Spirulina platensis, ensuring uniform distribution and binding of the marker throughout the food, allowing for reliable measurement of gastric emptying without radioisotopes and standardizing the meal composition for consistent results.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If quantitative gastric scintigraphy is used to measure gastric emptying, then direct measurement of meal exiting the stomach is achieved, but radiation exposure and procedural complexity increase
Solution Approach 1:
The patent extracts the measurement function from the radioactive marker itself and transfers it to the breath analysis system. The marker (13C-labeled compound) is ingested with the meal, and its metabolic byproducts are exhaled and detected, separating the measurement process from direct radiation exposure while maintaining measurement capability
Solution Approach 2:
The patent replaces the mechanical/scintigraphic detection system with a chemical/biological detection system. Instead of using gamma cameras to detect radioactive markers, the system uses breath analysis to detect 13CO2 or 13C-labeled breath condensate, substituting a non-invasive chemical detection method for the traditional imaging approach
2Measurement precision
If traditional scintigraphy methods are used, then gastric emptying can be measured, but standardization is lacking due to varying cooking parameters and food quality
Solution Approach 1:
The patent changes the measurement parameter from direct imaging of meal contents to detection of metabolic byproducts in breath. This parameter change allows for standardized measurement conditions because breath analysis is less sensitive to variations in meal preparation, cooking parameters, and food quality compared to direct scintigraphic imaging
Solution Approach 2:
The patent introduces breath (13CO2 or breath condensate) as an intermediary between the ingested marker and the detection system. This intermediary provides a standardized, quantifiable endpoint that is less affected by variations in meal preparation and digestion processes, improving measurement reliability
3Object-affected harmful factors
If non-radioactive markers are used instead of radioisotopes, then radiation exposure is reduced, but marker distribution uniformity becomes more difficult to achieve
Solution Approach 1:
The patent applies local quality by incorporating the 13C-labeled marker into specific components of the test meal (such as eggs or other proteins) rather than attempting to uniformly distribute it throughout the entire meal matrix. This localized incorporation ensures uniform marker distribution while maintaining the physiological integrity of the meal
Solution Approach 2:
The patent uses composite meal formulations that combine the 13C-labeled marker compound with carrier materials (such as eggs, proteins, or other food matrices). This composite approach ensures uniform distribution of the marker while maintaining the functional and physiological properties of the test meal
4Reliability
If fluid bed processing is used to create standardized meals, then marker distribution and meal composition are standardized, but processing complexity increases
Solution Approach 1:
The patent employs fluid bed processing technology that uses pneumatic principles to suspend and uniformly distribute marker particles throughout the meal components. The fluid bed system uses controlled air flow to create a uniform mixing environment, achieving standardized marker distribution through pneumatic agitation rather than complex mechanical mixing
Solution Approach 2:
The patent changes the physical state and processing parameters of the meal components during fluid bed processing. By controlling temperature, moisture content, and particle size distribution during the fluid bed process, the system achieves standardized meal composition and marker distribution using relatively simple equipment operations
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 method produces a standardized meal that ensures accurate and reliable measurement of gastric emptying, reducing errors and radiation exposure, while allowing for the use of non-radioactive markers, enhancing diagnostic consistency and safety across different populations and locations.
Implementation Method 1
fluidizing the food and the label, and agglomerating the fluidized food and label
Data Source
AI summary
A standardized, edible food containing a label for use in the measurement of gastric emptying by the quantification of marker excreted in the breath of the patient and methods of making the same using fluid bed granulation processing.
