Integrated Capillary Blood Collection Device with Automated Lancing
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Solution Overview
Problem
Current capillary blood collection devices are complex, prone to workflow variabilities that result in low sample quality issues such as hemolysis and micro-clots, and require high skill levels, while also causing patient discomfort and exposing blood, with a need for a device that can lance, squeeze, collect, stabilize, and dispense samples in a controlled manner.
Innovation Solution
A self-contained, fully integrated finger-based capillary blood collection device with a retractable lancing mechanism and cyclically squeezable holder to stimulate blood flow, incorporating a blood flow path and anticoagulant for stabilization, capable of collecting high volumes (up to 500 μL) and integrating with various collection containers for flexible applications.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Device complexity
If a hand-held needle or blade is used for blood collection, then the device complexity is reduced, but the ease of operation deteriorates due to psychological difficulty and physical discomfort
Solution Approach 1:
The device enables the patient to perform blood collection on themselves through an automated mechanism. The patient simply places their finger in the device and activates it, and the system automatically positions and deploys the lancet to puncture the finger and collect blood, eliminating the need for manual needle handling while maintaining patient autonomy
Solution Approach 2:
The manual mechanical action of holding and deploying a needle or blade is replaced by an automated mechanical system. The device uses a spring-loaded lancet mechanism that automatically positions and deploys the puncturing element when activated, substituting the complex manual dexterity required for simple finger placement
2Ease of operation
If automatic lancet devices are used to puncture skin, then the ease of operation is improved, but the device complexity increases due to spring mechanisms and triggering systems
Solution Approach 1:
The device combines multiple functions into a single integrated unit: the lancet housing, spring mechanism, activation trigger, and blood collection well are merged into one compact device. This consolidation reduces the number of separate components the user must handle while maintaining the automated functionality
Solution Approach 2:
The device performs multiple functions in sequence using a single mechanism: it stores the lancet, positions it against the finger, punctures the skin, collects the blood sample, and retracts the lancet. This multi-functionality reduces the need for multiple separate devices or manual steps
3Device complexity
If manual blood collection procedures are used, then the device complexity is reduced, but the reliability deteriorates due to workflow variabilities causing hemolysis and micro-clots
Solution Approach 1:
The device automatically performs the squeezing action to extract blood from the finger after puncture. The system uses the finger's natural anatomy and applied pressure to guide blood flow into the collection well, eliminating variability in manual squeezing technique that causes hemolysis
Solution Approach 2:
The manual mechanical action of squeezing the finger is replaced by a controlled mechanical system that applies pressure through the device structure itself. The holder and internal components work together to guide blood flow consistently into the collection well without the variability of human hand strength and technique
4Device complexity
If traditional blood collection methods are used, then the device complexity is reduced, but blood exposure increases requiring higher skill levels
Solution Approach 1:
The device extracts the blood collection process from the open environment into a closed, contained system. The lancet is housed within a protective housing, and the blood collects in a covered well, separating the blood sample from the external environment and reducing exposure risks
Solution Approach 2:
The device uses a housing structure that encloses the lancet and collection well, creating a protective barrier. This shell structure contains any potential blood exposure within the device boundaries, preventing contact with the user's hands or surrounding environment
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 device simplifies capillary blood collection by eliminating workflow variabilities, reducing hemolysis and micro-clots, and minimizing patient discomfort, while ensuring high-quality, uniformly mixed samples and reducing blood exposure through a closed system.
Implementation Method 1
a puncturing element moveable between a pre-actuated position wherein the puncturing element is retained within the interior and a puncturing position wherein at least a portion of the puncturing element extends through the inlet
Implementation Method 2
incorporating a blood flow path and anticoagulant for stabilization
Implementation Method 3
an associated blood flow path which ensures attachment and transfer of the capillary blood from the pricked finger site to the collection container
Data Source
AI summary
A device for obtaining a biological sample, such as a capillary blood collection device, that has the ability to lance and squeeze the finger, collect the sample, stabilize the sample, and subsequently dispense the sample in a controlled manner is disclosed. The device also simplifies and streamlines the capillary blood collection by eliminating workflow variabilities which are typically associated with low sample quality including hemolysis and micro-clots.