Transdermal Sampling Device Using Localized Heat for Interstitial Fluid Collection
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Solution Overview
Problem
Conventional methods for obtaining biological samples are invasive, painful, and require large sample volumes, leading to discomfort and increased risks of infection and contamination.
Innovation Solution
A non-invasive transdermal sampling and analysis device that uses a disruptor unit to generate localized heat, altering the permeability of the stratum corneum to collect interstitial fluid for analysis, which is then analyzed using biologically reactive elements and electrochemical sensors in a single step.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Quantity of substance
If conventional invasive methods are used to obtain biological samples, then sufficient sample volume can be obtained for analysis, but the procedure becomes painful and increases risk of infection and contamination
Solution Approach 1:
The patent replaces mechanical puncture methods with electrochemical dissolution of the stratum corneum. Instead of using sharp instruments to break through the skin barrier, the invention applies electrical current to generate heat that chemically dissolves the keratin in the stratum corneum, creating a painless pathway for sample collection.
Solution Approach 2:
The invention changes the physical state and properties of the stratum corneum through controlled heating. By applying electrical energy to raise the temperature of the disruptor element, the keratin undergoes structural changes that allow it to be dissolved and penetrated without mechanical force, thereby eliminating pain while maintaining sample access.
2Measurement precision
If conventional biosensors are used, then analyte concentration can be determined, but a relatively large sample volume is required which necessitates invasive procedures
Solution Approach 1:
The patent introduces an electrochemical cell as an intermediary between the biological sample and the measurement system. This cell performs enzymatic conversion of the analyte (e.g., glucose to gluconolactone) and generates an electrical signal proportional to the analyte concentration, enabling precise measurement with minimal sample volume.
Solution Approach 2:
The invention replaces mechanical sample collection methods with electrochemical detection. By using enzymes and electrical signals to detect analyte concentration, the system requires only trace amounts of interstitial fluid rather than larger blood samples, eliminating the need for invasive puncture procedures.
3Productivity
If repeated invasive testing is performed, then ongoing monitoring can be achieved, but cumulative pain and tissue damage increase
Solution Approach 1:
The patent replaces repeated mechanical punctures with a single electrochemical interface. The electrochemical cell can continuously or repeatedly measure analyte concentrations by detecting electrical signals from enzymatic reactions, eliminating the need for repeated skin punctures and thereby preventing cumulative tissue damage while maintaining high monitoring frequency.
4Object-affected harmful factors
If transdermal sampling is used to minimize invasion, then pain and infection risk are reduced, but the stratum corneum must be breached which requires controlled heating
Solution Approach 1:
The patent applies heating locally to only the area of the stratum corneum that needs to be penetrated. The disruptor element is positioned in direct contact with the skin surface, concentrating thermal energy precisely where needed to dissolve keratin and create a pathway for sample collection, while surrounding tissues remain at normal temperature and are unaffected.
Solution Approach 2:
The invention temporarily changes the temperature parameter of the stratum corneum to enable penetration, then returns it to normal. The controlled heating raises the temperature sufficient to dissolve keratin structures, creates the necessary pathway for sampling, and then the temperature is reduced back to physiological levels, ensuring safety and reversibility.
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 safe, pain-free, and accurate analysis of small biological samples with reduced contamination risk and time, minimizing skin damage and sample volume requirements.
Implementation Method 1
a disruptor unit to generate a localized heat that alters the permeability of the stratum corneum without damaging the stratum corneum
Implementation Method 2
Biosensors combine a biological component with a physiochemical detector component to allow for the detection of analytes in biological samples
Implementation Method 3
a transducer or detector elements which work in a physiochemical way (e.g., optical, piezoelectric, electrochemical, etc.), that may transform the signal resulting from the interaction of the analyte with the biological elements into another signal that can be more easily measured and quantified
Data Source
AI summary
Transdermal sampling and analysis device, method and system are provided for non-invasively and transdermally obtaining biological samples from a subject and determining levels of analytes of the obtained biological samples. The transdermal sampling and analysis device, method and system may cause disruption to the skin cells to create capillary-like channels from which biological samples may flow to the transdermal sampling and analysis device. The transdermal sampling and analysis device, method and system may collect the biological samples in a reservoir and transport the biological samples to a sensing chamber. The sensing chamber may contain at least two sensing electrodes coated with a biologically reactive element which reacts with the transported biological sample. The sensing chamber may be configured to mitigate the formation of air bubbles which may impede the transport and distribution of the biological sample across the entirety of the sensing chamber.