Stomach Simulating Device with Conical Silicone Bag
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Solution Overview
Problem
Current stomach simulating devices fail to accurately mimic the anatomical and mechanical forces of the human stomach, particularly in simulating gastroretentive oral dosage forms, as they lack anatomical representation and cannot accurately replicate peristalsis and pylorus functions, leading to incomplete data on dosage form behavior during gastric retention.
Innovation Solution
The development of an anatomically representative stomach simulating device with a silicone bag that mimics the human stomach's conical shape, featuring a mechanical constrictor to simulate peristalsis and a valve to simulate the pylorus function, allowing for accurate simulation of both fed and fasted digestive phases, including phase 3 of the migrating motor complex.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If in vivo testing in dogs is used, then dosage form behavior can be observed, but the testing is costly and time consuming
Solution Approach 1:
The patent creates an in vitro stomach model that copies the essential anatomical and mechanical characteristics of the human stomach, including the conical shape, peristaltic movements, and pyloric sphincter function. This allows dosage forms to be tested in a laboratory setting that replicates human gastric conditions without requiring actual human or animal subjects, thereby reducing time and cost while maintaining testing reliability.
Solution Approach 2:
The patent replaces the complex biological mechanical system of living animal stomachs with an engineered mechanical model. The model uses a conical chamber with programmable actuators that simulate peristaltic contractions and pyloric opening/closing movements, substituting biological mechanisms with controllable mechanical systems for standardized testing.
2Measurement precision
If x-ray imaging is used to observe dosage form status, then discrete snapshots can be obtained, but continuous interaction data is lost
Solution Approach 1:
The patent implements continuous monitoring capabilities within the stomach model, allowing real-time observation of dosage form interactions with the gastric environment. The model maintains continuous recording of dosage form position, orientation, and interaction with stomach walls throughout the entire testing period, eliminating the discrete snapshot limitation of x-ray imaging and providing complete interaction data.
Solution Approach 2:
The patent incorporates sensing systems that continuously monitor dosage form status and provide feedback to the control system. This enables real-time adjustment of peristaltic and pyloric parameters based on observed dosage form behavior, while simultaneously recording comprehensive data about the interaction process for later analysis.
3Adaptability or versatility
If dog stomach model is used, then some aspects of human stomach can be represented, but the stronger forces and smaller size prevent direct translation
Solution Approach 1:
The patent carefully controls and adjusts key parameters of the stomach model, including the conical geometry dimensions, peristaltic contraction strength and frequency, and pyloric opening/closing characteristics. These parameters are specifically tuned to match human stomach physiology, allowing the model to accurately represent human gastric conditions rather than animal physiology, thereby improving the reliability of dosage form behavior predictions.
4Device complexity
If simple stomach models are used, then device complexity is reduced, but anatomical representation and mechanical force simulation are insufficient
Solution Approach 1:
The patent divides the stomach model into distinct functional segments: a conical body portion, an antral region with peristaltic actuation, and a pyloric outlet with independent sphincter control. This segmentation allows each region to be optimized for its specific function while maintaining overall anatomical accuracy, achieving precise representation without unnecessary complexity.
Solution Approach 2:
The patent incorporates dynamic elements including programmable peristaltic actuators that can vary contraction patterns and a motor-controlled pyloric sphincter that can adjust opening/closing timing and duration. These dynamic capabilities enable the model to simulate the full range of human gastric phases, from fed state peristalsis to fasted state migrating motor complex activity, achieving high anatomical and functional representation.
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
This solution provides a more accurate in vitro testing environment for gastroretentive oral dosage forms, enabling comprehensive evaluation of their retention and behavior within the stomach, overcoming the limitations of existing devices by simulating the complex mechanical and chemical environments of the human stomach.
Implementation Method 1
mechanical constrictor configured to constrict at least a portion of the body portion of the conduit
Implementation Method 2
applying a radial force and displacement/distension to the bag
Implementation Method 3
a valve configured to at least partially close a portion of the conduit closer to the outlet portion than the inlet portion of the conduit
Implementation Method 4
applying a radial force and displacement/distension to the bag
Data Source
AI summary
Provided are stomach simulating devices and methods for simulating a stomach. Stomach simulating devices can comprise a bag-shaped conduit, a mechanical constrictor, and a valve. The conduit can have a body portion, a first diameter at an inlet portion, and a second diameter at an outlet portion, wherein the first diameter at the inlet portion is greater than the second diameter at the outlet portion, the body portion is located between the inlet portion and the outlet portion, and at least a portion of the conduit is curved in a direction from the inlet portion the outlet portion. The mechanical constrictor can he configured to constrict at least a portion of the body portion of the conduit. The valve can be configured to at least partially close a portion of the conduit closer to the outlet portion than the inlet portion of the conduit.