Ketone Body Sensing Patch Using Hollow Microneedles
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Solution Overview
Problem
Current methods for detecting ketosis or ketoacidosis are invasive, unreliable, or expensive, and lack accuracy, particularly when it comes to monitoring ketone bodies in interstitial fluid, which is crucial for dietary and disease management.
Innovation Solution
A minimally invasive patch sensor that collects interstitial fluid using hollow microneedles and features a colorimetric ketone body indicator, changing from an initial negative to a positive state when a threshold value of beta-hydroxybutyrate is detected, providing a visual indication of ketosis or ketoacidosis.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If invasive blood testing is used to detect ketone bodies, then measurement precision is improved, but ease of operation deteriorates
Solution Approach 1:
The patent uses an intermediary substance (glucose oxidase enzyme) that reacts with glucose in interstitial fluid to produce hydrogen peroxide, which then reacts with a chromogen to produce a color change. This indirect detection method allows accurate ketone body measurement without requiring invasive blood sampling, as interstitial fluid can be obtained through minimally invasive means.
Solution Approach 2:
The patent replaces the mechanical/invasive blood sampling system with a chemical-biological detection system using enzymes and colorimetric reactions. Instead of physically drawing blood, the device uses biochemical reactions in interstitial fluid to detect ketone bodies, eliminating the need for invasive procedures while maintaining measurement accuracy.
2Ease of operation
If urine testing with ketone strips is used, then ease of operation is improved, but reliability deteriorates
Solution Approach 1:
Instead of testing urine for ketone bodies as in conventional methods, the patent inverts the approach by testing interstitial fluid. This allows detection of ketone bodies at the source before they are excreted in urine, providing more reliable and timely information while maintaining the simplicity of strip-based testing.
Solution Approach 2:
The patent replaces urine-based chemical detection with enzyme-based colorimetric detection in interstitial fluid. The use of glucose oxidase and other enzymes provides more reliable and specific detection of ketone bodies compared to conventional urine strips, while maintaining ease of operation through a similar strip-based format.
3Ease of operation
If breath testing for acetone is used, then ease of operation is improved, but measurement precision deteriorates due to interference
Solution Approach 1:
The patent uses specific enzyme intermediaries (ketone body oxidase, glucose oxidase) that selectively react with target ketone bodies in interstitial fluid. This enzymatic mediation provides high specificity and accuracy, eliminating the interference problems encountered in breath testing where alcohol and other substances can affect acetone detection.
Solution Approach 2:
The patent replaces breath-based physical detection with biochemical detection in interstitial fluid. By using enzyme-catalyzed reactions that produce color changes, the system achieves high measurement precision without the interference issues of breath testing, while maintaining convenience through a simple application-based interface.
4Ease of operation
If colorimetric indicator is used to detect ketone bodies, then ease of operation is improved, but manufacturing precision requirements increase
Solution Approach 1:
The patent uses parameter changes in the form of color intensity and hue variations that correspond to different ketone body concentrations. By designing the colorimetric system to produce distinct visual changes at clinically relevant thresholds, the patent simplifies the readout while the manufacturing process incorporates pre-calibrated reagent layers with specific color response characteristics, making the threshold calibration inherent to the product design rather than a post-manufacturing adjustment.
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 device offers a convenient, inexpensive, and accurate means to detect ketone bodies in interstitial fluid, enabling effective monitoring of ketosis or ketoacidosis, facilitating better dietary and disease management by providing a simple-to-read visual indication of ketone levels.
Implementation Method 1
at least one hollow microneedle for penetrating skin of an individual to obtain interstitial fluid
Implementation Method 2
collects interstitial fluid using hollow microneedles
Implementation Method 3
a colorimetric ketone body indicator, changing from an initial negative to a positive state when a threshold value of beta-hydroxybutyrate is detected
Data Source
AI summary
Devices, patch sensors, and methods for detecting a ketone body are disclosed. An exemplary device includes a collection apparatus for collecting a sample amount of interstitial fluid and a ketone body indicator having an initial negative state and having a positive state when at least a threshold value of the ketone body is collected in the sample amount.