Porous Matrix Biosensor for Anastomotic Leak Detection
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Solution Overview
Problem
Current diagnostic methods for anastomotic leaks after gastrointestinal surgery lack sensitivity and specificity, leading to delayed detection and increased morbidity and mortality, with no definitive non-invasive test available for early identification.
Innovation Solution
A physiological change monitoring system comprising a porous matrix with embedded sensors that measure impedance changes, allowing for real-time detection of leaks by tracking electrical properties, which can be positioned near organs like the esophagus or gastrointestinal tract to detect fluid leaks using a contrast solution.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If upper GI contrast fluoroscopy is used to detect anastomotic leaks, then leak detection can be performed, but the sensitivity is low (40-60%) and requires invasive procedures or high-density barium
Solution Approach 1:
The patent replaces mechanical/optical diagnostic methods (fluoroscopy, endoscopy) with an electrical impedance-based sensing system. Sensors embedded in a porous matrix detect leaks through electrical property changes rather than requiring visual imaging or invasive mechanical insertion, thereby improving sensitivity while reducing invasiveness
Solution Approach 2:
The patent introduces a porous matrix as an intermediary medium between the sensors and the body cavity. This matrix absorbs contrast solution and allows sensors to indirectly detect leaks through impedance changes in the absorbed fluid, enhancing detection sensitivity without direct sensor contact with the leak site
2Measurement precision
If high-density barium is added to increase detection sensitivity, then sensitivity improves by 60%, but the procedure becomes more complex and potentially harmful
Solution Approach 1:
The patent changes the detection parameter from optical density (requiring high-density barium) to electrical impedance. This allows the use of low-density, safer contrast agents or even physiological fluids, eliminating the need for high-density barium while maintaining high detection sensitivity
Solution Approach 2:
The patent converts the potentially harmful high-density barium requirement into a benefit by using electrical impedance sensing that works effectively with safer, lower-density contrast agents or physiological fluids, thereby reducing adverse reactions while maintaining diagnostic accuracy
3Reliability
If routine post-operative diagnostic testing is performed to identify leaks early, then morbidity and mortality can be reduced, but the current methods lack definitive diagnostic capability
Solution Approach 1:
The patent creates a universal monitoring system that can detect multiple physiological parameters (impedance changes, pressure, flow) through a single integrated sensor platform. This provides definitive diagnostic capability for leaks while also monitoring other physiological functions, reducing the need for multiple separate diagnostic systems
Solution Approach 2:
The patent merges multiple diagnostic functions into a single sensor system that combines impedance sensing, porous matrix absorption, and real-time monitoring capabilities. This integration provides definitive leak detection while simplifying the overall diagnostic approach compared to using multiple separate tests
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 system achieves high sensitivity and specificity in detecting anastomotic leaks, potentially replacing existing methods like upper GI contrast fluoroscopy, offering real-time surveillance and reduced risk of adverse reactions from contrast agents, with the ability to monitor cardiac contractility and lung compliance.
Implementation Method 1
A biologically inert liquid, absorbed by the porous matrix, may leave the porous matrix during compression of the porous matrix contained by the container
Implementation Method 2
at least one sensor is configured to measure physiological changes in the opening in the body... the electrical properties measured include an impedance associated with the one or more sensors
Data Source
AI summary
The system and method may measure and monitor physiological changes in a body. In some embodiments, the system and method may measure the impedance at a site in the body. In some embodiments, the system and method identify, quantify, and localize leaks from a site following surgery, measure cardiac contractility, or lung compliance. In an embodiment, the system includes a measuring device with one or more sensors embedded in a porous matrix. Changes in the electrical properties of one or more sensors may be used to determine the presence of leaks from a site following surgery, measure cardiac contractility, or lung compliance, depending on the position of the device.