Bedside Biosensor Electrodes for Rapid Sepsis Biomarker Detection

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Solution Overview

Problem

Current biomarker tests for infections like sepsis require amplification and costly kits, delaying diagnosis and prognosis, and there is a need for reliable, bedside monitoring systems that can accurately detect multiple biomarkers for infection differentiation.

Innovation Solution

A clinical bedside system with biosensors that utilize working electrodes with antifouling membranes and capture antibodies to sandwich biomarkers for redox reactions, coupled with a potentiostat for precise biomarker concentration measurement, enabling rapid and accurate detection of multiple biomarkers.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If traditional biomarker tests with amplification and costly kits are used, then diagnostic accuracy is improved, but diagnosis time is delayed and cost increases

Engineering Contradiction:
Improvediagnostic accuracyVSAvoiddiagnosis time
Core Design Contradiction:
Measurement precisionVSLoss of time

Solution Approach 1:

The patent extracts the essential detection function from complex laboratory kits by implementing a simplified biosensor that directly detects biomarkers (IL-6, IL-10, PCT) in biological fluids without requiring amplification steps or costly reagent kits, enabling rapid bedside diagnosis

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The patent replaces traditional mechanical/lab-based detection systems with an electrochemical biosensor system that uses working electrodes, reference electrodes, and potentiostats to directly measure biomarker concentrations through electrochemical signals, eliminating the need for complex amplification machinery

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

2Measurement precision

If traditional biomarker tests with amplification and costly kits are used, then diagnostic accuracy is improved, but test cost increases

Engineering Contradiction:
Improvediagnostic accuracyVSAvoidtest cost
Core Design Contradiction:
Measurement precisionVSEase of manufacture

Solution Approach 1:

The patent employs disposable biosensor cartridges with integrated electrodes and antifouling membranes that can be manufactured at low cost and discarded after single use, eliminating the need for expensive reusable laboratory equipment and costly reagent kits while maintaining diagnostic accuracy

Inventive Principle:
Principle #27Cheap short-living objects (Disposable)

Solution Approach 2:

The patent removes expensive amplification reagents and complex kit components from the detection system, retaining only the essential electrochemical detection elements that can be manufactured cheaply and used directly for biomarker detection

Inventive Principle:
Principle #2Taking out (Extraction)

3Measurement precision

If multiple biomarkers are detected for infection differentiation, then diagnostic accuracy is improved, but device complexity increases

Engineering Contradiction:
Improveinfection differentiation accuracyVSAvoidbiosensor system complexity
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The patent divides the detection system into multiple independent working electrodes, each specialized for detecting a specific biomarker (IL-6, IL-10, PCT), allowing parallel detection of multiple markers without requiring a single complex multi-functional sensor, thus reducing overall system complexity

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The patent creates a universal biosensor platform where a single device with multiple electrodes can detect various biomarkers relevant to different infection types, eliminating the need for separate specialized tests and simplifying the overall diagnostic workflow

Inventive Principle:
Principle #6Universality (Multi-functionality)

4Productivity

If bedside monitoring is implemented, then clinical benefit is improved, but measurement precision requirements increase

Engineering Contradiction:
Improveclinical benefit rateVSAvoidbiomarker detection precision
Core Design Contradiction:
ProductivityVSMeasurement precision

Solution Approach 1:

The patent applies local quality enhancement by coating working electrodes with antifouling membranes and incorporating specific capture antibodies at each electrode surface, creating locally optimized detection zones that maintain high precision for bedside applications where bulk fluid composition may vary

Inventive Principle:
Principle #3Local quality

Solution Approach 2:

The patent introduces capture antibodies as intermediary elements that selectively bind to biomarkers in the biological fluid, concentrating them at the electrode surface to enhance detection precision and enable accurate measurement in the complex environment of bedside monitoring

Inventive Principle:
Principle #24Intermediary (Mediator)

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

Provides rapid, accurate, and cost-effective bedside detection of biomarkers for infection diagnosis and prognosis, allowing for timely intervention and improved clinical decision-making.

Implementation Method 1

The capture antibody is configured to capture a biomarker between it and a detection antibody of a homogenous population of detection antibodies including the detection antibody. Capture of the biomarker between the capture antibody and the detection antibody thusly sandwiches the biomarker between the capture antibody and the detection antibody

Methodology Applied
Scientific EffectSandwich assay:

Implementation Method 2

for a detectable redox reaction between an enzyme conjugated to the detection antibody and its corresponding working electrode

Methodology Applied
Scientific EffectRedox reaction: Redox Reactions

Implementation Method 3

for a detectable redox reaction between an enzyme conjugated to the detection antibody and its corresponding working electrode

Methodology Applied
Scientific EffectRedox reaction: Redox Reactions

Implementation Method 4

Each working electrode of the working electrode(s) has an antifouling membrane thereover to which a capture antibody or a homogenous population of capture antibodies including the capture antibody is immobilized

Methodology Applied
Scientific EffectAntifouling:

Implementation Method 5

A magnitude of the current is proportional to a concentration of the biomarker in a biological fluid to which the biosensor or its working electrode(s) are exposed

Methodology Applied
Scientific EffectElectrochemical measurement:

Data Source

PatentUS20250344968A1Clinical Bedside Systems and Methods with Biosensors for Complex Care Patients
Publication Date: 2025.11.13 BARD ACCESS SYSTEMS INC
  • US20250344968A1 patent drawing
  • US20250344968A1 patent drawing
  • US20250344968A1 patent drawing

AI summary

A clinical bedside system facilitates care for complex care patients. The system can include a medical device having a biosensor with an inert substrate and a working electrode, a counter electrode, and a reference electrode deposited thereon. The working electrode can have an antifouling membrane thereover to which a capture antibody is immobilized. The capture antibody can be configured to capture a biomarker between it and a detection antibody, thereby sandwiching the infection biomarker between the antibodies for a detectable redox reaction between an enzyme conjugated to the detection antibody and the working electrode. The counter electrode can complete completes an electrical circuit including the working electrode. The reference electrode can be operably connected to the electrical circuit. The reference electrode can be configured to provide a reference point against which changes in potential at the working electrode can be measured, for example, with a potentiostat.