# US 2014/0194765 A1 · Method of Exhaled Gas Measurement and Analysis and Apparatus Therefor

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- Number: US 2014/0194765 A1
- Document ID: US20140194765A1
- Status: Published application
- Kind: A1
- Application number: 13/565,437
- Filed: 2012-08-02
- Published: 2014-07-10
- Earliest claimed: 2006-02-03
- Assignees: Otsuka Pharmaceutical Co., Ltd.
- Inventors: Yasuhiro Kubo; Masaaki Mori
- Web page: https://patentgrep.com/patent/US20140194765A1

## CPC

- A61B 5/0836: {Measuring rate of CO2 production}
- A61B 5/097: Devices for facilitating collection of breath or for directing breath into or through measuring devices
- G01N 1/22: in the gaseous state {(specially adapted for biological material G01N33/497; measuring breath flow A61B5/087)}
- G01N 21/3504: for analysing gases, e.g. multi-gas analysis
- G01N 33/497: of gaseous biological material, e.g. breath
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- G01N: INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES (measuring or testing apparatus or processes other than immunoassay, involving enzymes or microorganisms C12M, C12Q)

## Abstract

An exhalation collected in a breath bag capable of expanding and contracting is sucked into a gas inlet vessel 21 with a given volume (Va), and then the gas inlet vessel 21 is communicated by means of valve V2 with a cell 11 that is maintained at an atmospheric pressure by being pre-filled with a sample gas or reference gas. After the communication, the gas pressure is measured by a pressure sensor 16 attached to the cell 11. Whether the exhalation collected in the breath bag is below a given amount or not can be accurately judged.

## Claims

### Claim 1

A method of exhaled gas measurement and analysis, comprising the steps of:
(a) collecting an exhalation of a human body including carbon dioxide 13C02 and carbon dioxide 12C02 as component gases into a breath bag capable of expanding and contracting;
(b) sucking a predetermined volume of the exhalation collected in the breath bag into a gas inlet vessel;
(c) measuring a pressure of the exhalation in the gas inlet vessel;
(d) cancelling a measurement upon determining that a amount of the exhalation collected in the breath bag is insufficient when the measured pressure value is below an atmospheric pressure;
(e) pushing the gas inlet vessel to fill a cell communicated with the gas inlet vessel with the exhalation when the measured pressure value is equal to the atmospheric pressure; and
(f) measuring intensities of light transmitted through the cell having wavelengths at which light is transmitted through the respective component gases, followed by data processing based thereon, thereby measuring 13C02 concentration or concentration ratio of carbon dioxide 13C02 to carbon dioxide 12C02.

### Claim 2 (depends on 1)

The method of exhaled gas measurement and analysis according to claim 1, wherein the breath bag has a maximum capacity volume that is equal to or greater than the predetermined volume of the exhalation sucked into the gas inlet vessel.

### Claim 3 (depends on 1)

The method of exhaled gas measurement and analysis according to claim 1, wherein in the step (b), after the predetermined amount of the exhalation collected in the breath bag is sucked into the gas inlet vessel, a valve for communication between the gas inlet vessel and the cell is opened so that the gas inlet vessel and an inside of the cell that is maintained at the atmospheric pressure by being pre-filled with a prescribed gas are communicated with each other, and
in the step (c), the gas pressure after the communication is measured by a pressure sensor attached to the cell.

### Claim 4 (depends on 3)

The method of exhaled gas measurement and analysis according to claim 3, wherein the prescribed gas is a reference gas that does not absorb the light having the wavelengths at which light is transmitted through the respective component gases.

### Claim 5 (depends on 4)

The method of exhaled gas measurement and analysis according to claim 4, wherein the reference gas is air.

### Claim 6 (depends on 1)

The method of exhaled gas measurement and analysis according to claim 1, wherein the exhalation inside the gas inlet vessel is pressurized up to the atmospheric pressure when the amount of the exhalation collected in the breath bag is determined to be insufficient, and
an amount of change in volume of the gas inlet vessel during the pressurization is shown as an amount of shortage to a measurer.

### Claim 7 (depends on 3)

The method of exhaled gas measurement and analysis according to claim 3, wherein the exhalation inside the gas inlet vessel is pressurized up to the atmospheric pressure when the amount of the exhalation collected in the breath bag is determined to be insufficient, and
an amount of change in volume of the gas inlet vessel during the pressurization is shown as an amount of shortage to a measurer.

### Claim 8 (depends on 1)

The method of exhaled gas measurement and analysis according to claim 1, further including the steps of:
collecting an exhalation of a human body before administration of a sample drug thereto to perform the exhaled gas measurement and analysis including the steps of (b) to (f);
collecting an exhalation of the human body after administration of the sample drug thereto to perform the exhaled gas measurement and analysis including the steps of (b) to (f); and
comparing results of both the measurements thereby to obtain a change in 13C02 concentration or a change in concentration ratio between carbon dioxide 13C02 and carbon dioxide 12C02.

### Claim at position 9

-10. (canceled)
