Ingestible Capsule for Gastrointestinal Transit Time Evaluation
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Solution Overview
Problem
Current methods for diagnosing constipation, such as radiopaque marker techniques and scintigraphy, are invasive, expensive, and lack precision in assessing gastrointestinal transit times, leading to inadequate patient management and potential misdiagnosis of upper gut involvement.
Innovation Solution
An ingestible capsule equipped with pH, temperature, and pressure sensors that records measurements as it passes through the gastrointestinal tract, allowing for the determination of transit times between specific locations, which are then compared to reference templates to evaluate constipation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If radiopaque marker techniques are used to assess colonic transit, then transit time measurement is achieved, but the method involves radiation exposure and lacks precision in assessing regional gut transit
Solution Approach 1:
The patent replaces radiopaque markers and scintigraphy (radiation-based methods) with an ingestible capsule containing pH, temperature, and pressure sensors. This substitution eliminates radiation exposure while providing continuous, precise measurements of gastrointestinal transit through physiological parameter monitoring along the GI tract.
Solution Approach 2:
The ingestible capsule acts as an intermediary device that indirectly measures transit time by recording pH, temperature, and pressure changes at different GI locations. Instead of directly tracking markers with radiation, the capsule uses physiological intermediaries (pH shifts, temperature variations, pressure patterns) to infer position and transit timing.
2Reliability
If multiple transit tests (whole gut and colonic) are performed to evaluate constipation, then diagnostic accuracy is improved, but the complexity and cost of evaluation increases
Solution Approach 1:
The single ingestible capsule performs multiple diagnostic functions simultaneously: it measures whole gut transit time, colonic transit time, and regional gut transit by recording pH, temperature, and pressure throughout the entire GI tract. This multi-functionality consolidates what were previously separate tests into one unified evaluation, maintaining diagnostic accuracy while reducing protocol complexity.
Solution Approach 2:
The patent merges multiple transit assessment functions (whole gut transit, colonic transit, regional transit) into a single integrated capsule system. By combining these previously separate measurement capabilities into one device, the system achieves comprehensive diagnostic accuracy without requiring multiple separate test procedures.
3Measurement precision
If conventional transit studies are used, then colonic transit differentiation is achieved, but upper gut involvement is missed leading to poor patient management
Solution Approach 1:
The patent extends the measurement dimension from solely colonic transit to the entire gastrointestinal tract by incorporating pH, temperature, and pressure sensors that detect position and physiological changes from the stomach through the small intestine to the colon. This dimensional expansion captures upper gut transit information that was previously inaccessible to colonic-only studies.
Solution Approach 2:
The capsule system segments the GI tract into distinct regions (stomach, small bowel, colon) by detecting characteristic pH, temperature, and pressure patterns in each segment. This segmentation allows independent assessment of transit time in each region, enabling identification of upper gut involvement while maintaining precise colonic transit measurement.
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 capsule method provides a non-invasive, cost-effective means to accurately assess gastrointestinal transit times, effectively differentiating between healthy and constipated subjects and guiding targeted treatments, with high sensitivity and specificity in identifying abnormal transit times.
Implementation Method 1
recording pH measurements from the pH sensor as a function of time as the capsule moves through at least a portion of the gastrointestinal tract of the subject
Implementation Method 2
recording temperature measurements from the temperature sensor as a function of time as the capsule moves through at least a portion of the gastrointestinal tract of the subject
Data Source
AI summary
A method for diagnosing constipation comprising the steps of providing an ingestible capsule (20) having a given density and a pH sensor (22) and a temperature sensor (24), having a subject ingest the capsule, recording pH measurements from the pH sensor as a function of time as the capsule moves through at least a portion of the gastrointestinal tract of the subject, transmitting the pH measurements to a processor (19) outside of the gastrointestinal tract of the subject, recording temperature measurements from the temperature sensor as a function of time as the capsule moves through at least a portion of the gastrointestinal tract of the subject, transmitting the temperature measurements to a processor (19) outside of the gastrointestinal tract of the subject, determining transit time of the capsule between a first location in the gastrointestinal tract of the subject and a second location in the gastrointestinal tract of the subject as a function of the pH measurements and the temperature measurements, providing a reference transit time that is a function of the density of the capsule, and comparing the determined transit time to the reference transit time to evaluate the subject for constipation.