Breath analysis system capable of controlling flow of an exhaled breath sample into an insertable cartridge

Abstract

A breath capture device for determining the concentration of acetone in a breath sample from a user. In some embodiments, the device includes a controller programmed to use stored data to control flow of a breath sample into an analysis chamber as the user exhales into a port. In other embodiments, the device includes a switch responsive to an action by the user that is operable between a first orientation in which breath entering the port preferentially travels through a second flow path and a second orientation in which breath entering the port preferentially travels through a first flow path. In still other embodiments, the device includes a flow regulator both responsive to user action and operable from a first position in which breath entering a port preferentially travels through a second flow path to a second position in which breath entering the port preferentially travels through a first flow path.

Description

PRIORITY CLAIM[0001]This application is a continuation of U.S. patent application Ser. No. 15 / 339,870 (Dkt. No. INVOY.017A), filed Oct. 31, 2016, which claims the benefit of U.S. Provisional Application Nos. 62 / 247,778 (Dkt. No. INVOY.017PR), filed Oct. 29, 2015, and 62 / 396,240 (Dkt. No. INVOY.029PR), filed Sep. 19, 2016, which are hereby incorporated herein by reference in their entirety. Any and all applications for which a foreign or domestic priority claim is identified in the Application Data Sheet as filed with the present application are hereby incorporated by reference under 37 CFR 1.57.BACKGROUND[0002]Field of the Invention[0003]The present invention relates to apparatuses, systems, and methods for sensing or measuring chemical components or constituents (e.g., analytes) in the breath of a patient or “subject,” and preferably endogenous analytes in breath, and correspondingly, to devices and methods for regulating the flow of the breath sample during the pre-measurement cap...

AI Technical Summary

Benefits of technology

[0036]In accordance with another embodiment, a method is provided for sensing an analyte in breath using a disposable cartridge. The method includes directing an alveolar breath sample through a first flow path, the first flow path comprising a porous disk and beads with affinity for the analyte; wherein the first flow path has a static dimension; directing the alveolar breath sample through a reactant in a reaction zone in a second flow path within the cartridge, wherein the reaction zone has an optical characteristic that is at a reference level; facilitating a change in the optical characteristic of the reaction zone relative to the reference level; and detecting the change in the optical characteristic to sense the analyte in the breath.

[0113]In accordance with one aspect of the invention, a method is provided for extending an effective working range of an analyzer for measuring an analyte in a breath sample. The method comprises initiating a reaction in the analyzer that produces an optically discernable reaction product having an optical property that is indicative of a concentration of the analyte in the breath sample. The method also comprises taking a first reading of the optical property at a first time, and comparing the first reading to a reference. If the comparison of the first reading to the reference has a first state, the method comprises determining the concentration using the first reading. If the comparison of the first reading to the reference has a second state different from the first state, the method comprises taking a second reading of the optical property at a second time and determining the concentration of the analyte using the second reading.

Problems solved by technology

Patients associate this procedure with pain, a factor that can have adverse implications for patient compliance in home-based assessments.

Given the logistics and economics, the lab analysis usually is carried out in bulk on large numbers of samples, thus requiring bulk handling and logistics considerations and introducing delay into the time required to obtain results.

In large part because of these logistics and delays, it is usually necessary for the patient or subject to return for a follow up visit, thus taking additional clinical time and causing additional expense.

Such tests can be messy, unsanitary, and introduce issues with respect to labeling, handling and contamination avoidance.

They also usually involve lab analysis, with associated delays and expense.

Given the logistics, the lab analysis usually is carried out in bulk on large numbers of samples, thus again involving delay and expense.

Notwithstanding these potential benefits, however, with the exception of breath ethanol devices used for law enforcement, there has been a paucity of breath analyzers on the commercial market, particularly in medically-related applications.

This lack of commercialization is attributable in large measure to the relatively substantial technical and practical challenges associated with the technology.

In addition, the requirements for discrimination or selectivity is of critical concern.

Successfully and reliably sensing a particular analyte in such a heterogeneous and chemically-reactive environment presents substantial challenges.

Published reports generally have been limited to the determination of the production rate of carbon dioxide and the consumption rate of oxygen.

These approaches have been limited and relatively deficient, however, for example, in that the breath sample or samples are collected in bulk, so that the analyte of interest is mixed in with other constituents.

This often dilutes the analyte and increases the difficulty of discriminating the desired analyte.

These approaches also limit the flexibility of the breath analysis to undertake more specialized or complex analyses.

Additionally, such approaches are relatively deficient because the instrumentation used for single breath analysis usually is different from and sometimes inadequate for multiple breath analyte measurement.

Yet another challenge to breath analysis involves the fluid mechanical properties of the breath sample as it travels through the measurement device.

The background matrix of breath presents numerous challenges to sensing systems, which necessitate complex processing steps and which further preclude system integration into a form factor suitable for portable usage by layman end-users.

For example, breath contains high levels of humidity and moisture, which may interfere with the sensor or cause condensation within the portable device, amongst other concerns.

Devising a breath analyzer thus is a non-trivial task, made all the more difficult to extent one tries to design and portable and field-amenable device.

Notably, the measurement of endogenous analytes in breath presents different challenges and requires different techniques and devices than the measurement of exogenous analytes.

There are a number of significant challenges to measuring endogenous analytes in breath.

This leads to unique challenges in chemical sensitivity, selectivity and stability.

Because of the historical difficulty in even detecting endogenous breath analytes, other challenges have not been extensively investigated.

Colorimetric approaches to endogenous breath analysis have historically been plagued with lengthy response times, and expensive components.

More specifically, in some instances there is a concern that components of the cartridge, for example, such as chemical components, may be adversely affected by ambient light.

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