Bio-contained Sputum Imaging Cartridge for Acid-fast Bacilli Detection

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Solution Overview

Problem

Current methods for detecting acid-fast bacilli in sputum smear microscopy are limited by low sensitivity, variable quality, inadequate sample sizes, lack of necessary equipment, and undertrained technicians, particularly in low-income and developing countries, necessitating a more efficient, accurate, and inexpensive system.

Innovation Solution

A system comprising a pipette and imaging cartridge that allows for bio-contained specimen preparation, staining, and imaging, featuring a pipette with a sampling chamber and sachet for reagents, and an imaging cartridge with a decolorizer reagent and magnet for spreading the specimen, enabling efficient detection of acid-fast bacilli without specialized training.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of manufacture

If direct sputum smear microscopy is used for detecting acid-fast bacilli, then the method is inexpensive and efficient, but the sensitivity is low and variable

Engineering Contradiction:
Improvecost effectivenessVSAvoiddetection sensitivity
Core Design Contradiction:
Ease of manufactureVSMeasurement precision

Solution Approach 1:

The system divides the microscopy process into separate functional modules: a pipette for sample acquisition, an imaging cartridge for specimen preparation and staining, and a microscope for detection. This segmentation allows each component to be optimized independently, improving overall sensitivity while maintaining cost-effectiveness through standardized, disposable components.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The imaging cartridge performs preliminary actions including specimen preparation, staining with fluorescent dyes, and mounting before the actual microscopy detection. This pre-processing enhances the visibility and detectability of acid-fast bacilli, thereby improving sensitivity without requiring complex equipment or specialized training.

Inventive Principle:
Principle #10Preliminary action

2Reliability

If traditional microscopy methods are used, then equipment is required, but access to expensive microscopy methods is limited in low-income countries

Engineering Contradiction:
Improvedetection accuracyVSAvoidequipment requirements
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent merges multiple functions (sample acquisition, specimen preparation, staining, mounting, and detection) into an integrated system where the pipette couples with the imaging cartridge, which then interfaces with the microscope. This consolidation reduces the need for separate expensive equipment and specialized skills, making reliable detection accessible in resource-constrained settings.

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The system employs disposable, low-cost components including the pipette and imaging cartridge that can be manufactured inexpensively and discarded after use. This eliminates the need for expensive, maintainable equipment while ensuring consistent detection accuracy through standardized disposable components.

Inventive Principle:
Principle #27Cheap short-living objects (Disposable)

3Measurement precision

If manual specimen preparation is performed, then technique quality varies, but standardized testing is difficult to achieve

Engineering Contradiction:
Improvetesting quality consistencyVSAvoidtraining requirements
Core Design Contradiction:
Measurement precisionVSEase of operation

Solution Approach 1:

The imaging cartridge performs self-service by automatically executing the specimen preparation and staining protocols through its integrated reagents and mechanisms. This eliminates variability introduced by manual techniques, ensuring consistent testing quality without requiring extensive training or specialized skills from the operator.

Inventive Principle:
Principle #25Self-service

Solution Approach 2:

The system standardizes critical parameters such as staining time, reagent concentration, and specimen volume through controlled conditions in the imaging cartridge. This parameter control ensures reproducible results across different operators and settings, achieving testing quality consistency without increasing operational complexity.

Inventive Principle:
Principle #35Parameter changes

4Measurement precision

If adequate sample size is obtained, then detection accuracy improves, but inadequate sample sizes limit diagnostic reliability

Engineering Contradiction:
Improvedetection accuracyVSAvoidsample size
Core Design Contradiction:
Measurement precisionVSQuantity of substance

Solution Approach 1:

The system replaces manual mechanical sample transfer with an automated pipetting mechanism that precisely delivers a standardized volume of specimen to the imaging cartridge. This substitution ensures adequate sample size is consistently obtained, improving detection accuracy while eliminating the variability and inadequacy of manual sampling.

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

The system provides standardized, contamination-reduced testing with minimal training and equipment, enhancing sensitivity and accuracy in detecting acid-fast bacilli, making it suitable for resource-constrained settings.

Implementation Method 1

The magnet may be configured to move from one end of the imaging chamber to an opposite end of the imaging chamber for spreading the specimen therein

Methodology Applied
Scientific EffectMagnetic force: Magnetism

Implementation Method 2

the cartridge blister may be configured to release the at least one decolorizer reagent therein when a force is applied to the cartridge blister

Methodology Applied
Scientific EffectDecolorization: Chemical Bonding

Data Source

PatentUS11060127B2Imaging cartridge, pipette, and method of use for direct sputum smear microscopy
Publication Date: 2021.07.13 BECTON DICKINSON & CO
  • US11060127B2 patent drawing
  • US11060127B2 patent drawing
  • US11060127B2 patent drawing

AI summary

An assembly for preparing a specimen is provided that may be configured to determine the presence of at least one microorganism specie in the specimen. The assembly may include a pipette configured to acquire a specimen from a sample and an imaging cartridge configured to be in fluid communication with the pipette. The imaging cartridge and the pipette may be configured to be irreversibly coupled such that the specimen is bio-contained within the imaging cartridge and the pipette when the imaging cartridge and pipette are coupled together. Associated methods of use are also provided.