Modular Fluid Handling System for Point-of-Care Diagnostics

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Solution Overview

Problem

Current clinical testing methods are hindered by human errors, lengthy processing times, limited accessibility, and inefficiencies in sample collection and analysis, leading to delayed diagnosis and inadequate treatment, particularly for time-sensitive conditions, which compromises the quality and timeliness of medical care.

Innovation Solution

A modular system comprising sample preparation, assay, and detection stations that can perform various laboratory procedures, including centrifugation, immunoassays, and cytometric assays, designed for point-of-service use, with a focus on rapid, accurate, and frequent diagnostics, capable of processing small sample volumes with low coefficient of variation.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If samples are transported to centralized laboratories for testing, then comprehensive analysis can be performed, but the turn around time becomes prohibitively long and sample integrity degrades during transport

Engineering Contradiction:
Improvetest result accuracyVSAvoidturn around time
Core Design Contradiction:
Measurement precisionVSLoss of time

Solution Approach 1:

The centralized laboratory testing system is segmented into distributed point-of-care testing devices. Each device contains integrated sample preparation, assay, and detection capabilities that were previously centralized, enabling local testing without sample transport while maintaining comprehensive analysis capabilities

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

A fluid handling system with automated sample processing acts as an intermediary between sample collection and analysis. The system includes robotic liquid handling, automated pipetting, and integrated reagent delivery that eliminates manual processing steps and enables rapid local testing

Inventive Principle:
Principle #24Intermediary (Mediator)

2Adaptability or versatility

If manual sample preparation and analysis are performed, then flexibility in processing methods is maintained, but human errors increase and processing efficiency decreases

Engineering Contradiction:
Improveprocessing flexibilityVSAvoiderror rate
Core Design Contradiction:
Adaptability or versatilityVSReliability

Solution Approach 1:

The testing system performs sample preparation, reagent dispensing, and analysis automatically without human intervention. The fluid handling system includes self-calibrating pipettes, automated sample lysis, and robotic liquid handling that eliminate manual processing errors while maintaining processing flexibility through programmable protocols

Inventive Principle:
Principle #25Self-service

Solution Approach 2:

Manual mechanical sample processing is replaced with automated fluid handling systems. The system uses robotic liquid handling, automated pipetting mechanisms, and computer-controlled sample preparation that eliminate human error while maintaining adaptability through software-controlled protocols

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

3Quantity of substance

If large volumes of blood are drawn for testing, then sufficient sample material is obtained for comprehensive analysis, but patient discomfort increases and compliance decreases

Engineering Contradiction:
Improvesample volumeVSAvoidpatient compliance
Core Design Contradiction:
Quantity of substanceVSEase of operation

Solution Approach 1:

The system is designed to process small partial volumes of blood samples efficiently. The automated fluid handling system can perform complete testing protocols with minimal sample volumes (e.g., capillary blood draws) that were previously insufficient for comprehensive analysis, thereby improving patient compliance

Inventive Principle:
Principle #16Partial or excessive action

Solution Approach 2:

The testing system changes the parameter of sample volume requirement from large volumes to small volumes through optimized assay designs. The platform uses highly sensitive detection methods and efficient sample preparation techniques that enable comprehensive testing with minimal blood draws

Inventive Principle:
Principle #35Parameter changes

4Loss of time

If frequent testing is conducted to monitor disease progression, then timely intervention is enabled, but the burden of repeated visits to collection sites increases

Engineering Contradiction:
Improvedetection timeVSAvoidtesting infrastructure
Core Design Contradiction:
Loss of timeVSDevice complexity

Solution Approach 1:

The point-of-care testing device is designed as a universal platform that can perform multiple different assays and test types in a single integrated system. This multi-functionality enables frequent monitoring without requiring different specialized locations or complex infrastructure for different test types

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

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 and accurate clinical testing at the point of care, reducing delays in diagnosis and treatment, improving patient outcomes, and lowering healthcare costs by providing timely and reliable data for medical professionals.

Implementation Method 1

a centrifuge

Methodology Applied
Scientific EffectCentrifugal separation: Centrifugal Separation

Implementation Method 2

immunoassays

Methodology Applied
Scientific EffectImmunoassay:

Implementation Method 3

cytometric assays

Methodology Applied
Scientific EffectCytometric assay:

Data Source

PatentUS11524299B2Systems and methods for fluid handling
Publication Date: 2022.12.13 LABRADOR DIAGNOSTICS LLC
  • US11524299B2 patent drawing
  • US11524299B2 patent drawing
  • US11524299B2 patent drawing

AI summary

Systems and methods are provided for sample processing. A device may be provided, capable of receiving the sample, and performing one or more of a sample preparation, sample assay, and detection step. The device may be capable of performing multiple assays. The device may comprise one or more modules that may be capable of performing one or more of a sample preparation, sample assay, and detection step. The device may be capable of performing the steps using a small volume of sample.