Transdermal Sampling Device Using Localized Heat and Redox Cofactors

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Solution Overview

Problem

Conventional biosensors require invasive procedures and large biological samples for accurate analyte concentration measurement, are time-consuming, and prone to contamination, especially for patient home monitoring applications.

Innovation Solution

A transdermal sampling and analysis device that uses localized heat to disrupt the stratum corneum, allowing for non-invasive collection and analysis of interstitial fluid, incorporating a sensing element with an enzyme and cofactor to measure analyte levels, such as oxidoreductases with NAD+, within a hydrogel matrix on sensing electrodes.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If conventional biosensors are used for analyte measurement, then measurement precision can be achieved, but the procedure becomes invasive and requires large biological samples

Engineering Contradiction:
Improveanalyte concentration measurement accuracyVSAvoidinvasiveness and contamination risk
Core Design Contradiction:
Measurement precisionVSObject-affected harmful factors

Solution Approach 1:

The patent introduces an intermediary substance (cofactor such as NAD+, FAD, or plastoquinone) that mediates between the enzyme and the analyte. This cofactor layer enables the enzyme to function effectively in detecting analytes like glucose, lactate, or ethanol without requiring invasive blood sampling, thus reducing contamination risk while maintaining measurement precision

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The patent replaces the mechanical/invasive sampling method with a chemical/biochemical detection system. Instead of physically collecting blood samples through puncture, the device uses enzymatic reactions at the electrode surface to detect analytes directly through the skin or from minimal fluid, eliminating the harmful mechanical intrusion

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

2Measurement precision

If conventional biosensor procedures are used, then analyte levels can be measured, but the process becomes time-consuming

Engineering Contradiction:
Improveanalyte concentration measurementVSAvoidmeasurement process duration
Core Design Contradiction:
Measurement precisionVSLoss of time

Solution Approach 1:

The patent incorporates the cofactor layer onto the electrode surface in advance, before the actual measurement is needed. This preliminary preparation ensures that when the analyte is introduced, the enzymatic reaction can proceed immediately without requiring additional setup time, thus reducing the overall measurement process duration while maintaining accuracy

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The cofactor layer remains continuously active on the electrode surface, ready to facilitate enzymatic reactions at any moment. This continuous readiness eliminates interruptions and waiting periods in the measurement process, enabling rapid and continuous monitoring of analyte levels

Inventive Principle:
Principle #20Continuity of useful action

3Measurement precision

If conventional biosensors are used, then analyte measurement can be performed, but the device complexity increases

Engineering Contradiction:
Improveanalyte concentration measurementVSAvoidbiosensor structure complexity
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The patent divides the biosensor into distinct functional layers: the electrode base, the enzyme layer, and the cofactor layer. This segmentation allows each component to be optimized independently and simplifies the overall construction process, reducing device complexity while maintaining measurement precision through specialized functional zones

Inventive Principle:
Principle #1Segmentation

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 rapid, accurate, and minimally invasive measurement of analyte concentrations with reduced sample volume and contamination risk, providing a one-step process for in situ analysis.

Implementation Method 1

the at least one disruptor may be configured to generate a localized heat capable of altering permeability characteristics of a stratum corneum layer of skin of an organism

Methodology Applied
Scientific EffectLocalized heat generation: Joule Heating

Implementation Method 2

the cofactor may catalyze a reaction to determine levels of an analyte in the biological fluid sample

Methodology Applied
Scientific EffectCatalysis: Catalysis

Implementation Method 3

Some enzymes that have attracted attention for detecting certain analytes work in the presence of a cofactor, which may bind to the active site of the enzyme and function as an intermediate carrier of electrons

Methodology Applied
Scientific EffectRedox reactions: Redox Reactions

Implementation Method 4

the surface of at least one of the sensing electrodes may be coated with a sensing layer comprising an enzyme immobilized within a hydrogel

Methodology Applied
Scientific EffectImmobilization: Adsorption

Data Source

PatentUS11633129B2Non-invasive transdermal sampling and analysis device incorporating redox cofactors
Publication Date: 2023.04.25 CAMBRIDGE MEDICAL TECHNOLOGIES LLC
  • US11633129B2 patent drawing
  • US11633129B2 patent drawing
  • US11633129B2 patent drawing

AI summary

Systems and methods are provided for determining levels of an analyte in a biological fluid sample. A transdermal sampling and analysis device may include a substrate, at least one disruptor mounted on the substrate, a reservoir configured to collect and contain a biological fluid sample; a sensing element comprising at least two sensing electrodes, and at least one layer of a cofactor covering the sensing element in which the cofactor catalyzes a reaction to determine levels of an analyte in the biological fluid sample. The at least one disruptor of the transdermal sampling and analysis device may generate a localized heat capable of altering permeability characteristics of a stratum corneum layer of skin of an organism. The surface of at least one of the sensing electrodes of the transdermal sampling and analysis device may be coated with a sensing layer in which an enzyme immobilized within a hydrogel.