Blood Sample Collection Device with Integrated Reagent Mixing

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Solution Overview

Problem

The complexity and resource-intensive process of preparing blood samples for point-of-care testing, which requires multiple individuals and extensive time, resources, and expertise, leading to potential contamination and delayed test results.

Innovation Solution

A method and device involving a sample container with a detachable cap and body, where the cap is used to collect a fluid sample and reagents are added to the body, allowing for mixing and analysis using an imaging platform like a flow cytometer, reducing the need for multiple steps and minimizing contamination.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Productivity

If traditional multi-step blood sample preparation process is used, then thorough mixing and reagent addition can be achieved, but the process requires multiple individuals, extensive time, and numerous resources

Engineering Contradiction:
Improvesample preparation speedVSAvoidpreparation process complexity
Core Design Contradiction:
ProductivityVSDevice complexity

Solution Approach 1:

The patent combines multiple preparation steps (blood collection, reagent addition, mixing) into a single integrated container system. The container includes integrated components such as the cap with lancet for blood collection, the body with reagent reservoir, and the mixing mechanism, allowing one person to complete the entire preparation process in about 15 minutes without transferring samples between multiple tubes or containers.

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The container is divided into functional segments: a cap portion for blood collection containing a lancet, a body portion for reagent storage, and a mixing section. This segmentation allows each component to perform its specific function while working together as an integrated system, reducing the need for multiple separate devices and manual transfer steps.

Inventive Principle:
Principle #1Segmentation

2Reliability

If multiple manual transfer steps are performed, then sample preparation can be completed, but the risk of contamination increases

Engineering Contradiction:
Improvesample accuracyVSAvoidcontamination risk
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

By combining blood collection and reagent addition into a single container without requiring transfer steps, the patent eliminates the contamination risk associated with manual sample handling. The blood is collected directly into the container and reagents are added within the same sealed system, maintaining sample integrity throughout the preparation process.

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The container is designed to perform multiple functions automatically: the lancet automatically pierces the skin and collects blood, the reagents are automatically mixed with the sample through inversion or shaking, and the sample is ready for analysis without manual intervention. This self-service design minimizes human contact with the sample, reducing contamination risk.

Inventive Principle:
Principle #25Self-service

3Measurement precision

If traditional preparation methods are used, then comprehensive sample analysis can be performed, but the time required for preparation is extensive

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

Solution Approach 1:

The container is pre-filled with the required reagents in precise amounts before use. The lancet is pre-attached to the cap, and the reagent compartments are pre-positioned. This preliminary preparation eliminates the need for manual measurement and addition of reagents during the sample collection process, reducing preparation time while maintaining diagnostic accuracy.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The design allows continuous progression through the preparation steps without interruption: blood collection immediately followed by reagent addition and mixing within the same container. The sample remains in the container throughout the entire process, allowing continuous action without stopping for transfer or storage, thus reducing total preparation time while preserving sample quality for accurate diagnosis.

Inventive Principle:
Principle #20Continuity of useful action

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

This approach significantly reduces the time, resources, and expertise required for preparing blood samples while maintaining accuracy, potentially completing the process in as little as 15 minutes and minimizing contamination.

Implementation Method 1

The support reagent may... diluting and reconstituting dried reporters

Methodology Applied
Scientific EffectDilution:

Implementation Method 2

facilitating the staining of any particles within the fluid sample (e.g., by binding the reporters to those particles)

Methodology Applied
Scientific EffectBinding: Chemical Bonding

Implementation Method 3

facilitating the lysis of red blood cells within the fluid sample in instances of whole blood analysis

Methodology Applied
Scientific EffectLysis:

Data Source

PatentUS11666917B2Collection and preparation of blood samples for point-of-care diagnostics
Publication Date: 2023.06.06 BECKMAN COULTER INC
  • US11666917B2 patent drawing
  • US11666917B2 patent drawing
  • US11666917B2 patent drawing

AI summary

This disclosure is directed to methods and devices (300) associated with Point of Care medical testing and diagnostics. More specifically, methods and devices are described which provide a quick and streamlined way to prepare blood samples for analysis using flow cytometers, microscopes, and other analysis platforms. The benefits include a reduction in the time, resources, and expertise needed for preparing those blood samples without compromising the accuracy and efficacy of diagnosing diseases or identifying specific particulates from those blood samples.