Analyte detection from breath samples

Inventors

Lynn, Michael ScottHeanue, Joseph A.Anekal, Samartha G.LIMTAO, Kevin M.Dunk, Kevin BradfordSchuster, Jeffrey A.

Assignees

Triple Ring Technologies IncHound Labs Inc

Publication Number

US-11187711-B1

Publication Date

2021-11-30

Expiration Date

2038-09-06

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Abstract

Systems and techniques for collecting and analyzing breath samples to detect one or more target analytes are disclosed.

Core Innovation

The invention provides methods, systems, and apparatus for collecting and analyzing breath samples to detect one or more target analytes, particularly tetrahydrocannabinol (THC). The disclosed technology employs immunoassay-based detection systems, enabling analysis of minute analyte concentrations in exhaled human breath. The system includes a cartridge with reaction channels designed for picogram-level sensitivity, microfluidic architecture, and the capability to store and process breath samples for on-site or laboratory analysis.

The key problem addressed is the difficulty in detecting small amounts of THC in exhaled breath, which is much less prevalent than alcohol and only reliably indicates recent use and impairment within a narrow window. Existing detection methods using blood or urine may result in false positives for impairment. This invention aims to provide a convenient, non-invasive, and accurate means of roadside detection for THC impairment, with analysis correlating breath THC levels to recent consumption independent of use frequency.

The system further allows for comparison of the determined amount of THC in breath to a defined threshold level associated with recent consumption, and outputs an indication as to whether this threshold is exceeded. The microfluidic cartridge may include multiple reaction channels to process sample and control analyte levels, supports data transmission for results, and can be adapted for combined THC and alcohol detection or for identifying other breath-borne substances relevant to disease states.

Claims Coverage

The independent claim defines several inventive features related to a cartridge for collecting and analyzing breath samples, which interfaces with a handheld unit and a base station. There are multiple inventive features provided in the claim.

Cartridge with dedicated reaction channels and controls

The cartridge comprises: - One or more sample ports. - A first reaction channel fluidically connected to the sample ports for sample analysis. - A second and a third reaction channel configured to facilitate analysis of first and second controls for the analyte, with such controls contained within the cartridge. This structure enables in-cartridge comparison of breath samples with internal controls for the target analyte.

Pumping assist ports for vacuum/suction connection

The cartridge includes one or more pumping assist ports that are: - Fluidically connected to the first reaction channel via flow paths inside the cartridge. - Positioned to interface with a suction port on a handheld sample collection unit. - Allowing a suction pump in the handheld unit to assist in drawing breath through the reaction channel during collection. This feature facilitates efficient sample capture at low analyte concentrations.

Configurable interface with sample collection unit and base station

The cartridge is specifically configured to: - Be separately and releasably interfaced with both a handheld sample collection unit and a base station. This feature allows the breath sample to be collected in the field and then analyzed in a separate station, offering flexibility and security in sample processing.

In summary, the main inventive features involve a cartridge providing segregated reaction channels for sample and controls, a pumping assist interface for vacuum-augmented sample collection, and the ability to interface distinctly with both a handheld sample device and a base station.

Stated Advantages

Enables highly sensitive detection of THC and other analytes at picogram-per-liter levels in breath samples.

Provides convenient, reliable, and non-invasive roadside detection and determination of recent THC use.

Device can be adapted for simultaneous detection of THC and alcohol, and for detection of other airborne substances and disease indicators.

System ensures device scalability and sample integrity, including options for sample storage for evidentiary purposes.

Facilitates on-site analysis with potential wireless transmission of results to remote locations for efficient data management.

Documented Applications

Roadside breath testing for THC to determine recent use and potential impairment during traffic stops.

Combined roadside testing for both THC and alcohol from a single breath sample.

Detection and evaluation of other airborne or breath-borne controlled substances.

Detection of breath-borne indicators of various disease states, including stomach cancer, lung cancer, heart failure, kidney failure, or diabetes.

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