Handheld Bodily Fluid Collection Device with Integrated Electronics

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Solution Overview

Problem

Conventional methods for withdrawing and analyzing bodily fluids are tedious, time-consuming, and pose challenges related to quality control and chain-of-custody, particularly in clinical trials where patients need to travel to clinics for sample collection and analysis.

Innovation Solution

A handheld bodily fluid collection device equipped with electronics that allows patients to withdraw and analyze bodily fluids independently, featuring a housing with a movable actuator, a skin-piercing assembly, vacuum mechanism, and electronic components for measuring and storing characteristics of the fluid, including temperature, time, and patient identity, which can wirelessly communicate with external devices for quality control and chain-of-custody tracking.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Productivity

If conventional methods are used for withdrawing and analyzing bodily fluids, then quality control and chain-of-custody can be maintained through centralized clinic processing, but the process becomes tedious and time-consuming requiring patient travel and waiting

Engineering Contradiction:

Improvesample collection efficiencyVSAvoidtime for patient travel and waiting

Core Design Contradiction:

ProductivityVSLoss of time

Solution Approach 1:

The device enables patients to independently withdraw and analyze their own bodily fluids at home without requiring clinic visits. The integrated electronics automatically measure sample characteristics and maintain quality control data, allowing patients to complete the entire sampling process themselves while the system autonomously tracks chain-of-custody information.

Inventive Principle:

Principle #25Self-service

Solution Approach 2:

The patent combines multiple functions into a single handheld device: sample withdrawal mechanism, vacuum-driven fluid transport, electronic sensing for automatic measurement, and wireless communication for data transmission. This integration eliminates the need for separate clinic-based processing steps and reduces overall process time.

Inventive Principle:

Principle #5Merging (Combining)

2Ease of operation

If patients withdraw their own bodily fluids using take-home handheld devices, then time loss and convenience are improved, but quality control and chain-of-custody issues arise

Engineering Contradiction:

Improvepatient convenienceVSAvoidquality control and chain-of-custody

Core Design Contradiction:

Ease of operationVSReliability

Solution Approach 1:

The device incorporates electronic sensors that automatically measure and record sample characteristics (temperature, volume, collection time) and provide real-time feedback on sample quality. The system continuously monitors chain-of-custody data and transmits quality metrics to external systems, ensuring reliability is maintained despite decentralized sampling.

Inventive Principle:

Principle #23Feedback

Solution Approach 2:

The integrated electronics act as an intermediary between the patient-operated sampling mechanism and the laboratory analysis system. The electronic components automatically measure sample parameters, validate quality criteria, and transmit chain-of-custody information, bridging the gap between patient convenience and laboratory quality requirements.

Inventive Principle:

Principle #24Intermediary (Mediator)

3Device complexity

If manual sample collection and transport processes are used, then device complexity is low, but contamination risks increase and quality control becomes difficult

Engineering Contradiction:

Improvecollection device structureVSAvoidcontamination risk

Core Design Contradiction:

Device complexityVSObject-affected harmful factors

Solution Approach 1:

The patent replaces manual mechanical handling with an automated vacuum-driven fluid transport system. The vacuum mechanism automatically draws bodily fluid from the collection site through sealed tubing into the sample container, eliminating the need for manual transfer steps that could introduce contamination. The electronic sensors further replace manual quality assessment with automated measurement.

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

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 efficient, independent bodily fluid collection and analysis, ensuring immediate measurement and quality control of the sample, reducing contamination risks and streamlining the process while maintaining chain-of-custody accountability from collection to laboratory delivery.

Implementation Method 1

a vacuum mechanism, and electronic components for measuring and storing characteristics

Methodology Applied

Scientific EffectVacuum: Vacuum

Data Source

PatentUS20250000403A1Bodily fluid collection devices including electronics and associated systems and methods

Publication Date: 2025.01.02 TASSO INC

AI summary

Bodily fluid withdrawing devices including electronics, and associated systems and methods, are disclosed. In some embodiments, the devices include a housing containing a bodily fluid withdrawing feature, an actuator movable relative to the housing, and one or more electronic component(s). The electronic component(s) can be configured to transition from an inactive state to an active state when the device is actuated and a circuit of the device is closed. Upon transitioning to the active state, the electronic component(s) can be configured to wirelessly transmit information and/or receive information from an external recipient. In some embodiments, the devices disclosed herein can comprise part of an interconnected system including one or more communication devices.