Microneedle Sensor Array for Simultaneous Ketone and Glucose Detection
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Solution Overview
Problem
Current methods for monitoring diabetic ketosis and diabetic ketoacidosis lack continuous and minimally-invasive solutions for simultaneously tracking glucose and ketone bodies, relying solely on glucose measurements, which are inadequate for early diagnosis and management.
Innovation Solution
A microneedle-based electrochemical sensor platform with an array of microneedles that penetrates the skin to detect β-hydroxybutyrate and glucose in interstitial fluid, using an enzymatic functionalization layer with β-hydroxybutyrate dehydrogenase enzyme and a redox mediator for real-time, continuous monitoring.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If current glucose-only monitoring methods are used, then the monitoring system is simple, but the diagnostic capability for diabetic ketoacidosis is inadequate
Solution Approach 1:
The patent combines multiple sensing functions (glucose detection and ketone body detection via β-hydroxybutyrate dehydrogenase) into a single microneedle sensor array. This merging of functions allows simultaneous monitoring of multiple biomarkers, enhancing diagnostic capability while maintaining a unified device structure that does not significantly increase complexity
Solution Approach 2:
The microneedle sensor array is designed with universal applicability for detecting multiple diabetes-related biomarkers including glucose and ketone bodies. The sensor platform can be configured with different enzymatic functionalization layers to detect various analytes, making it a multi-functional diagnostic tool that addresses limitations of single-marker monitoring
2Reliability
If continuous monitoring of multiple biomarkers is implemented, then early detection capability is improved, but the invasiveness and complexity increase
Solution Approach 1:
The sensor system is segmented into multiple individual microneedles (e.g., 3-7 microneedles per sensor) rather than using a single large invasive probe. Each microneedle can be independently functionalized with specific enzymes for detecting different biomarkers. This segmentation reduces the invasiveness of each individual needle while enabling continuous monitoring of multiple biomarkers through the collective array, thereby improving early detection capability without proportionally increasing skin trauma
3Measurement precision
If enzymatic functionalization with β-hydroxybutyrate dehydrogenase is used, then ketone body detection sensitivity is improved, but the device manufacturing complexity increases
Solution Approach 1:
The microneedles are pre-functionalized with β-hydroxybutyrate dehydrogenase enzyme and other necessary components during the manufacturing process. This preliminary enzymatic functionalization ensures that the sensors are ready for immediate use with high detection sensitivity upon application. The enzyme is incorporated into the microneedle structure before deployment, eliminating the need for complex post-manufacturing assembly steps and reducing overall manufacturing complexity despite the sophisticated sensing capability
Solution Approach 2:
The microneedle structure employs composite materials that integrate the enzyme functionalization layer with the needle substrate. This composite construction combines the mechanical properties of the needle material with the biochemical functionality of the enzyme layer, achieving high ketone body detection sensitivity while streamlining the manufacturing process through material integration rather than separate assembly components
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
Enables real-time, continuous, and simultaneous monitoring of ketone bodies and glucose levels, providing early detection of diabetic ketoacidosis and improving diabetes management with high sensitivity and selectivity, overcoming the limitations of existing technologies.
Implementation Method 1
an enzymatic functionalization layer coupled to the electrode structure and comprising a β-hydroxybutyrate dehydrogenase (HBD) enzyme
Implementation Method 2
operable to detect β-hydroxybutyrate (HB) in the interstitial fluid through an electrochemically-mediated enzymatic reaction
Implementation Method 3
a redox mediator coupled to the electrode structure to facilitate electron transfer in the electrochemically-mediated enzymatic reaction
Implementation Method 4
a plurality of microneedle electrodes coupled to the substrate and operable to penetrate within skin and contact the microneedle electrodes with interstitial fluid
Data Source
AI summary
Disclosed is a wearable microneedle sensor platform for minimally-invasive, real-time monitoring of key biomarkers. In some aspects, a device includes a wearable epidermal sensor comprising an array of hollowed needles, each hollowed needle having a protruded needle structure including multiple layers forming a hollow interior, at least one hollowed needle including a working electrode to interact with one or more chemical or biological substances that come in contact with the protruded needle structure, at least one hollowed needle including a counter electrode to measure an electrical potential difference with the working electrode; and a wireless transmitter in communication with the sensor to generate output signals based on the electrical potential difference with the working electrode. The output signal represents β-hydroxybutyrate as a biomarker of ketone bodies.