Fluidic Cartridge for Real-Time Analyte Detection

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Solution Overview

Problem

Current point-of-care testing methods lack an integrated solution for sample acquisition, testing, analysis, and communication of results, and are inadequate for monitoring pharmacokinetic and pharmacodynamic parameters of drugs, leading to delayed data response and poor patient compliance, which can result in adverse drug reactions.

Innovation Solution

A fluidic device with a cartridge containing a sample collection unit and an assay assembly that collects and processes bodily fluid samples, allowing for real-time detection of analytes using immunoassays and wireless communication of results, enabling efficient data transmission and monitoring of drug efficacy and toxicity.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If traditional laboratory analyses are used to determine pharmacokinetic and pharmacodynamic parameters, then measurement precision can be achieved, but loss of time increases due to sample processing delays and patient visits to clinics

Engineering Contradiction:
Improvedetection accuracy of analytesVSAvoiddata response time
Core Design Contradiction:
Measurement precisionVSLoss of time

Solution Approach 1:

The system divides the testing process into discrete functional modules: sample collection unit, assay assembly with reaction sites, and communication assembly. This segmentation allows each component to perform its specific function efficiently and enables parallel processing of multiple samples, reducing overall test time while maintaining precision through dedicated assay chambers

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The device performs preliminary sample collection and processing at the point-of-care location before laboratory analysis would be needed. By collecting and preparing samples locally with the integrated assay assembly, the system eliminates the time loss associated with transporting samples to laboratories and waiting for processing results

Inventive Principle:
Principle #10Preliminary action

2Measurement precision

If multiple blood samples are collected at different time points to monitor drug parameters, then measurement precision improves, but device complexity and loss of time increase due to multiple patient visits

Engineering Contradiction:
Improvepharmacokinetic parameter accuracyVSAvoidsample processing system complexity
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The assay assembly is designed with multiple reaction sites that can accommodate different assays for various analytes within a single device. This multi-functionality allows the system to perform multiple measurements (pharmacokinetic and pharmacodynamic parameters) in one integrated platform, eliminating the need for separate testing devices and reducing overall system complexity

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

Solution Approach 2:

The system merges sample collection, sample processing, multiple assays, and communication capabilities into a single integrated device. By combining these functions that would traditionally require separate laboratory instruments and manual processes, the device reduces complexity while enabling comprehensive monitoring of multiple parameters across different time points

Inventive Principle:
Principle #5Merging (Combining)

3Measurement precision

If pre-processing of blood samples is performed before analysis, then measurement precision improves, but loss of time increases and productivity decreases

Engineering Contradiction:
Improveanalyte detection accuracyVSAvoiddata collection throughput
Core Design Contradiction:
Measurement precisionVSProductivity

Solution Approach 1:

The sample collection unit performs preliminary sample preparation activities locally at the point-of-care location, including sample stabilization and initial processing steps. By completing these pre-processing actions before the actual assay, the system prepares samples in advance without delaying the main analysis, thereby maintaining both precision and productivity

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The integrated device enables continuous sample processing and assay execution without interruption. The automated fluidic system maintains continuous flow from sample collection through processing to analysis, eliminating idle time and delays associated with manual sample transfer and processing steps, thus improving overall productivity while preserving measurement precision

Inventive Principle:
Principle #20Continuity of useful action

4Productivity

If an integrated solution for sample acquisition, testing, analysis and communication is implemented, then productivity and ease of operation improve, but device complexity increases

Engineering Contradiction:
Improvedata collection efficiencyVSAvoidfluidic system complexity
Core Design Contradiction:
ProductivityVSDevice complexity

Solution Approach 1:

The device employs a nested architecture where the sample collection unit, assay assembly with multiple reaction sites, and communication assembly are integrated within a compact cartridge format. This nesting allows multiple functional components to be contained within a small footprint, improving productivity and ease of operation while managing device complexity through modular integration

Inventive Principle:
Principle #7Nested doll (Nesting)

Solution Approach 2:

The integrated device performs self-contained operations including automatic sample collection, processing, assay execution, and data communication without requiring external laboratory infrastructure. This self-service capability improves productivity by eliminating the need for multiple separate processes while managing complexity through automated integrated control rather than manual coordination of separate systems

Inventive Principle:
Principle #25Self-service

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

Facilitates rapid, convenient, and accurate detection of analytes in bodily fluids, improving patient monitoring and compliance, and reducing adverse drug reactions by providing real-time data on drug efficacy and toxicity.

Implementation Method 1

the assay assembly comprises at least one reaction site containing a reactant that reacts with the analyte to yield a signal indicative of the presence of the analyte

Methodology Applied
Scientific EffectImmunoassay:

Data Source

PatentUS10533994B2Systems and methods of sample processing and fluid control in a fluidic system
Publication Date: 2020.01.14 GOLDEN DIAGNOSTICS CORP
  • US10533994B2 patent drawing
  • US10533994B2 patent drawing
  • US10533994B2 patent drawing

AI summary

This invention is in the field of medical devices. Specifically, the present invention provides portable medical devices that allow real-time detection of analytes from a biological fluid. The methods and devices are particularly useful for providing point-of-care testing for a variety of medical applications.