Blood Glucose Meter Sample Volume Detection and Reapplication

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Solution Overview

Problem

Current blood glucose monitoring devices often fail to collect and transport an adequate sample volume in a single attempt, leading to wasted tests, increased user pain, and higher costs due to the need for repeated skin penetration and sampling.

Innovation Solution

A device and method that includes a sensor to detect inadequate sample volumes, allowing users to reapply body fluid within a timed period, with optional features like milking or catalysts to enhance sample collection, and anticoagulants to prevent coagulation, enabling successful analysis.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If a skin-penetration member is used to collect body fluid sample, then sample acquisition is enabled, but the device cannot be re-cocked to reuse the same penetration member, leading to test wastage when sample volume is inadequate

Engineering Contradiction:

Improvetest success rateVSAvoiddevice structure

Core Design Contradiction:

ReliabilityVSDevice complexity

Solution Approach 1:

The skin-penetration member is designed with a reusable cocking mechanism that allows it to be reset and reused multiple times. The member can be cocked back into its initial position after penetration, enabling the same member to pierce the skin again if sample volume is inadequate, thereby eliminating test wastage without requiring complete device replacement.

Inventive Principle:

Principle #15Dynamics

Solution Approach 2:

Instead of discarding the skin-penetration member after a single use, the device recovers and repositions the same member for subsequent sampling attempts. The cocking mechanism restores the member to its ready state, allowing it to be used again if the initial sample was insufficient, thus preventing waste of the penetration member and test resources.

Inventive Principle:

Principle #34Discarding and recovering

2Measurement precision

If the device requires adequate sample volume for analysis, then measurement accuracy is ensured, but users experience increased pain and frustration when sample is inadequate

Engineering Contradiction:

Improveanalyte concentration accuracyVSAvoiduser pain and frustration

Core Design Contradiction:

Measurement precisionVSObject-affected harmful factors

Solution Approach 1:

The device incorporates a sensor that detects sample volume adequacy and provides feedback to the user through visual or audible signals. When sample volume is sufficient, the device confirms readiness for analysis; when inadequate, it alerts the user to apply more sample, thereby preventing premature analysis and ensuring measurement accuracy while reducing user frustration through clear guidance.

Inventive Principle:

Principle #23Feedback

Solution Approach 2:

The device performs preliminary detection of sample volume before initiating the analysis process. This preliminary action ensures that adequate sample is present, preventing wasted analysis attempts and ensuring measurement precision. The user is guided to apply additional sample if needed, reducing pain and frustration by avoiding repeated failed tests.

Inventive Principle:

Principle #10Preliminary action

3Reliability

If multiple separate components are used for sampling and quantification, then functional reliability is improved, but device portability and user simplicity deteriorate

Engineering Contradiction:

Improvesampling and analysis reliabilityVSAvoiduser operation simplicity

Core Design Contradiction:

ReliabilityVSEase of operation

Solution Approach 1:

The device merges the skin-penetration member, sample transport mechanism, and analyte quantification components into a single integrated unit. This unified structure maintains the functional reliability of separate components while improving portability and ease of operation. The integrated design eliminates the need for users to handle multiple separate devices, simplifying the overall operation while preserving the reliability of each functional subsystem.

Inventive Principle:

Principle #5Merging (Combining)

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 reduces test wastage, minimizes user discomfort, and lowers costs by allowing users to salvage tests with inadequate initial samples, improving the efficiency and flexibility of blood glucose monitoring.

Implementation Method 1

a sensor constructed and arranged to detect the presence or absence of an adequate sample volume applied to the at least one analyte quantification member

Methodology Applied

Scientific EffectSample volume detection:

Implementation Method 2

the controller is configured and arranged such that upon detection of the absence of an adequate sample volume, the controller initiates a finite timed period and signals the user to introduce another sample of body fluid

Methodology Applied

Scientific EffectTime measurement:

Data Source

PatentUS20240341634A1Detection meter and mode of operation

Publication Date: 2024.10.17 INTUITY MEDICAL INC

AI summary

A method for performing an assay to determine the presence or concentration of an analyte contained in a sample of body fluid by using a device comprising at least one analyte quantification member and a sensor associated therewith, the method includes: applying a first sample to the analyte quantification member; and detecting the presence or absence of an adequate sample volume; wherein upon detection of the absence of an adequate sample volume, initiating a finite timed period, and signaling the user to introduce a second sample of body fluid to the analyte quantification member. Associated arrangements and devices are also disclosed.