Point-of-Care Blood Sampling Apparatus with Integrated Mixing Valve
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Solution Overview
Problem
Traditional point-of-care medical testing requires samples to be shipped to remote laboratories for analysis, leading to delays in result availability, and existing point-of-care test kits lack reliable and user-friendly fluid-sample collection apparatuses that can accurately collect, dilute, and dispense precise blood samples without operator error or cross-contamination.
Innovation Solution
A self-contained apparatus that collects a predefined volume of whole blood from a fingerstick, mixes it with a dilution reagent, and dispenses a precise volume of diluted blood into a point-of-care test kit, featuring a mixing valve and plunger system for efficient fluid handling, and is designed to be simple, maintenance-free, and prevent re-use to ensure consistent results.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If a self-contained collection apparatus is used to collect, dilute and dispense blood samples, then measurement precision and reliability are improved, but device complexity increases
Solution Approach 1:
The patent combines multiple functions (collection, dilution, mixing, and dispensing) into a single integrated apparatus. The collection apparatus includes a capillary tube for blood collection, a mixing chamber with dilution reagent, and a dispensing mechanism, all integrated into one device that performs the complete sample preparation workflow without requiring separate tools or steps.
Solution Approach 2:
The apparatus is designed to be self-contained with pre-filled dilution reagents and automatic mixing mechanisms. The plunger system automatically draws diluted blood into the capillary tube and dispenses it into the test kit without requiring manual intervention for each step, making the system self-sufficient and user-friendly while maintaining precision.
2Reliability
If a single-use disposable apparatus is used to prevent cross-contamination, then reliability is improved, but manufacturing precision requirements increase
Solution Approach 1:
The patent designs a disposable single-use apparatus that is discarded after one application to eliminate cross-contamination risks. The collection apparatus is intended for single use only, with the understanding that each unit is sterile and pre-assembled, eliminating the need for sterilization processes and ensuring consistent performance across all units while simplifying manufacturing quality control.
3Ease of operation
If the apparatus is designed for simplicity and maintenance-free operation, then ease of operation is improved, but device complexity may increase
Solution Approach 1:
The apparatus incorporates automatic mixing mechanisms where the plunger system automatically draws diluted blood into the capillary tube and dispenses it into the test kit without requiring manual intervention for each step. The pre-filled dilution reagents and integrated mixing chamber eliminate the need for separate mixing actions, making the system self-sufficient and user-friendly while maintaining precision.
Solution Approach 2:
The dilution reagents are pre-filled in the collection apparatus during manufacturing, and the capillary tube is pre-assembled with the mixing chamber. This preliminary preparation eliminates the need for users to perform separate dilution and mixing steps, reducing operational complexity while ensuring consistent results across all uses.
4Reliability
If the apparatus works consistently independent of collection technique, then reliability is improved, but device complexity increases
Solution Approach 1:
The apparatus uses a plunger system that creates controlled pressure changes to draw blood into the capillary tube and dispense the diluted sample. The mixing chamber design ensures that regardless of slight variations in collection technique or blood flow rate, the dilution ratio remains consistent through controlled mixing action, and the dispensing mechanism maintains precise volume delivery independent of operator technique.
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
The apparatus enables rapid, accurate, and reliable collection and dilution of blood samples at the point of care, reducing the risk of erroneous results and ensuring consistent performance across various collection techniques, while being suitable for mass production and storage within a wide temperature range.
Implementation Method 1
collect a predefined volume of whole blood from a fingerstick
Implementation Method 2
mix the whole blood with a dilution reagent
Implementation Method 3
A plunger reciprocates within the main body between a retracted limit position and a distal limit position for creating negative and positive pressure within the internal cavity
Implementation Method 4
A mixing valve is located intermediate the capillary tube and the internal cavity for selectively connecting and disconnecting a fluid-flow channel between the capillary tube and the internal cavity
Data Source
AI summary
An apparatus for collecting, diluting and dispensing a predetermined volume of a patient fluid sample, such as blood, into the collection port of a point-of-care diagnostic test. The apparatus is constructed and arranged to collect a predefined volume of fluid sample by wicking, to mix the whole blood with a dilution reagent, and to dispense a predefined volume (within predefined tolerances) of diluted fluid sample into the collection port of the POC test kit. The apparatus has an elongate body with an internal cavity and a capillary tube in fluid connection with the internal cavity. A mixing valve separates the capillary tube and the internal cavity and selectively opens and closes the fluid connection between the capillary tube and the internal cavity. A plunger reciprocates within the valve body between a retracted limit position and a distal limit position for creating negative and positive pressure within the internal cavity.