Microneedle Biosensor for Continuous Tissue Viability Monitoring
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Solution Overview
Problem
Current methods for assessing tissue viability during reconstructive surgeries, such as free flap surgeries, are subjective, time-consuming, and lack continuous, objective monitoring, leading to delayed and inaccurate detection of tissue compromise, which can result in significant complications and increased healthcare costs.
Innovation Solution
A wearable microneedle biosensor device with an array of electrochemical sensors that can autonomously measure intradermal metabolites like lactate, pyruvate, and glucose, providing real-time, continuous assessment of tissue viability by directly detecting metabolic changes.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If conventional methods for assessing tissue viability are used, then the assessment can be performed with simple equipment, but the detection is delayed and inaccurate due to subjective evaluation
Solution Approach 1:
The patent replaces subjective mechanical/visual assessment methods with electrochemical biosensors that objectively measure metabolite concentrations. The biosensors convert chemical signals (metabolite levels) into electrical signals for precise, quantifiable tissue viability assessment, eliminating subjectivity and delay in detection.
Solution Approach 2:
The patent introduces metabolites (lactate, pyruvate, glucose) as intermediary substances that reflect tissue viability status. By measuring these metabolic markers through biosensors, the system indirectly but accurately assesses tissue health without directly observing tissue condition, enabling early and objective detection.
2Reliability
If continuous monitoring of tissue viability is implemented, then early detection of tissue compromise is achieved, but the device complexity and cost increase
Solution Approach 1:
The patent implements continuous monitoring capability where biosensors continuously measure metabolite concentrations in real-time during and after surgery. This continuous data stream provides ongoing assessment of tissue viability, enabling immediate detection of compromise without intermittent checks, thereby improving reliability while managing complexity through integrated sensor design.
Solution Approach 2:
The patent establishes a feedback loop where biosensor measurements of metabolite levels continuously inform tissue viability status. The system processes sensor signals and provides real-time feedback on tissue health, allowing clinicians to respond immediately to detected changes, thereby enhancing monitoring reliability through closed-loop information flow.
3Loss of information
If multiple metabolites are measured simultaneously, then comprehensive tissue health assessment is achieved, but the manufacturing complexity of the sensor array increases
Solution Approach 1:
The patent divides the sensing function into multiple specialized microneedle sensors, each potentially targeting specific metabolites (lactate, pyruvate, glucose). This segmentation allows simultaneous measurement of multiple metabolites through an array of specialized sensors, achieving comprehensive metabolic profiling while managing manufacturing complexity through modular sensor design and standardized fabrication processes.
Solution Approach 2:
The patent creates a multi-functional microneedle array where a single device platform can measure multiple different metabolites. The universal sensor design incorporates multiple sensing elements that can detect various metabolic markers, enabling comprehensive tissue health assessment through one integrated device rather than requiring separate sensors for each metabolite.
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 allows for early detection of tissue viability issues, reducing the risk of flap failure, shortening ICU stays, and improving surgical outcomes by offering a more objective and quantitative method for tissue health assessment.
Implementation Method 1
an electrochemical sensor electrode to detect an electrical signal from a reaction with a target analyte in a biofluid
Data Source
AI summary
Disclosed are miniaturized, wearable microneedle biosensor devices, systems, and methods for measuring intradermal concentrations of various metabolites (including but not limited to lactate, pyruvate, and/or glucose) in order to directly assess the viability of living tissue (e.g., human or other mammalian soft tissue). In a variety of implementations, for example, the disclosed microneedle biosensor devices are self-contained in terms of power source, sample acquisition, measurement, and data transmission capabilities, e.g., allowing it to function autonomously once placed. In some implementations, for example, the disclosed microneedle biosensor devices can assess the viability of soft tissue (e.g., skin with or without fat, fascia, or muscle) during and after reconstructive surgery in which soft tissue is repositioned, rotated, or transferred to another site in the body (including but not limited to both microvascular free tissue transfer and regional pedicled flaps).