Device and method for the analysis of the air exhaled by a subject in order to measure the basal metabolism thereof

• US 10,136,837 B2
• Filed: 10/21/2016
• Issued: 11/27/2018
• Est. Priority Date: 10/23/2015
• Status: Active Grant

• Current Assignee: COSMED S.r.l.
• Original Assignee: COSMED S.r.l.
• Inventors: Brugnoli, Paolo, Di Pietro, Alberto, Ragusa, Marco, Celentano, Domenico
• Primary Examiner(s): Natnithithadha, Navin
• Assistant Examiner(s): Messersmith, Eric J
• Application Number:
  US15/299,510
• Publication Number:
  US 20170112413A1
• Time in Patent Office: 767 Days
• CPC Class Codes: A61B 2505/03 Intensive care
• CPC Class Codes: A61B 2560/0223 of calibration, e.g. protocols for calibrating sensors
• CPC Class Codes: A61B 2560/029 adapted for auto-initiation
• CPC Class Codes: A61B 5/0803 Recording apparatus specially adapted therefor
• CPC Class Codes: A61B 5/083 Measuring rate of metabolism by using breath test, e.g. measuring rate of oxygen consumption
• CPC Class Codes: A61B 5/0833 Measuring rate of oxygen consumption
• CPC Class Codes: A61B 5/0836 Measuring rate of CO2 production
• CPC Class Codes: A61B 5/087 Measuring breath flow
• CPC Class Codes: A61B 5/097 Devices for facilitating collection of breath or for directing breath into or through measuring devices
• CPC Class Codes: G01N 2033/4977 metabolic gass from microbes, cell cultures, plant tissues and the like
• CPC Class Codes: G01N 33/497 of gaseous biological material, e.g. breath

Abstract

A device and a method for the analysis of the air exhaled by a subject in order to measure basal metabolism of the subject comprise a main line for a sampling flow of the air exhaled by a subject who breathes spontaneously or a subject undergoing assisted pulmonary ventilation. A mixing mini-chamber is provided for mixing a plurality of air sampling flows exhaled by the subject within a number of respiratory cycles. Sensors for sensing the oxygen concentration and the carbon dioxide concentration respectively measure the oxygen concentration and the carbon dioxide concentration within the air flow in the main line. The device further comprises an electronic control unit which processes signals from the sensors for obtaining a measurement of metabolism of the subject within a number of respiratory cycles. The electronic control unit is further programmed for automatically starting, upon switching on the device, a self-calibration stage of the device, by connecting the main line to a calibration line while causing the calibration flow to pass through a by-pass line by-passing the mixing mini-chamber, so that the calibration can be performed immediately, without requiring a filling of the mixing mini-chamber.

Claims

1. Device for the analysis of the air exhaled by a subject in order to measure basal metabolism of the subject, the device comprising:

a main line, for passage of a sampling flow of the air exhaled by the subject,

a suction pump having a substantially constant flow rate, said pump being arranged downstream of the main line, for drawing said sampling air flow into the main line,

a mixing mini-chamber interposed in the main line upstream of the suction pump for accumulating or mixing with each other a plurality of air sampling flows exhaled by the subject within a number of respiratory cycles,

a by-pass line arranged in parallel to the mixing mini-chamber through which the air flow can flow without passing through said mixing mini-chamber,

a by-pass valve interposed in the main line downstream of the mixing mini-chamber and selectively displaceable in two different positions for causing the airflow through the main line to flow either through the mixing mini-chamber or through said by-pass line,

first sensor means for sensing the oxygen concentration and second sensor means for sensing the carbon dioxide concentration, said first and second sensor means being arranged in the main line between said by-pass valve and the suction pump, for measuring the oxygen concentration and the carbon dioxide concentration within the air flow through the main line downstream of the mixing mini-chamber,

a first switching valve for switching the suction inlet of the suction pump between a condition of connection to said first and second sensor means and a condition in which this connection is interrupted,

flow measuring means for detecting the flow rate of the air inhaled or exhaled by the subject, and

an electronic controller configured for;

receiving and processing signals emitted by said first sensor means of the oxygen concentration, by said second sensor means of the carbon dioxide concentration and by said flow measuring means so as to obtain a measurement of oxygen consumption and carbon dioxide production by the subject within a number of respiratory cycles,

wherein said device further comprises;

a first inlet connector connected to a system for taking a flow of air exhaled by a subject who breathes spontaneously,

a second inlet connector connected through a sampling line to a system for taking a flow of air exhaled by a subject undergoing assisted pulmonary ventilation,

a selection valve interposed in the main line upstream of the mixing mini-chamber for selectively connecting said first connector or said second connector to said main line,

said selection valve having an outlet connected to the main line, a first inlet connected to said first connector and the second inlet for connection to said second connector,

a calibration line, which receives a calibration flow, to be used for calibrating said first and second sensor means for sensing the oxygen concentration and the carbon dioxide concentration,

a second switching valve adapted to be switched between a sampling state and a calibration state, said switching valve being controlled by said electronic controller for selectively connecting said second inlet of said selection valve to said sampling line connected to said second connector or to said calibration line,

a plurality of selector valves distributed in series along said calibration line for selectively connecting the calibration line each time to one only among a plurality of auxiliary lines adapted to provide respective calibration data,

said electronic controller being configured so that, during normal operation of the device, the selection valve is switched for feeding to the main line either a sampling flow of the air exhaled by a subject who breathes spontaneously or by a subject which undergoes assisted pulmonary ventilation, said by-pass valve being in a position causing the airflow to pass through said mixing mini-chamber so that said electronic controller is able to perform said processing in order to obtain said measurement of the oxygen consumption and the carbon dioxide production by the subject within a number of respiratory cycles,

said electronic controller being further programmed for automatically starting, upon switching on the device, a self-calibration stage of the device in which;

the second switching valve communicates said second connector of said selection valve to said calibration line while the selection valve communicates its second inlet to said main line, so that the main line enters into communication with said calibration line,

said electronic controller being configured so that in said self-calibration stage the by-pass valve is in a position which causes said sampling flow of the air exhaled by the subject to flow through said by-pass line, without passing through said mixing mini-chamber, whereby the self-calibration stage can be carried out immediately on the basis of the flow coming from said calibration line, without requiring a filling of said mixing mini-chamber.

2. Device according to claim 1, wherein said control unit is programmed so that:

when the device operates with a subject undergoing assisted pulmonary ventilation, said electronic unit controls said first switching valve in a Pulse Width Modulation (PWM) mode, in order to determine a flow rate of the suction pump which varies in proportion to the variation of the flow during the respiratory cycle of the subject,

whereas when the device operates with a subject who breathes spontaneously, said electronic unit controls the first switching valve in order to determine a constant sampling flow rate,

so as to ensure in any case a substantial precision of said measurement, notwithstanding said sampling flow constitutes only a fraction of the total flow of the air exhaled by the subject.

3. Device according to claim 1, wherein said auxiliary lines comprise:

a Fraction of inspired oxygen (FiO2) line connected to a line which feeds air to a subject undergoing assisted pulmonary ventilation, to enable a detection of the percentage of oxygen present in the air inhaled by the subject undergoing assisted pulmonary ventilation,

a first line for taking ambient air to enable a detection of the composition of the ambient air, said first line for taking the air being used in the case of measurement of basal metabolism on a subject who breathes spontaneously,

a second line for taking ambient air, in which a means is interposed for absorbing carbon dioxide, adapted to remove completely the carbon dioxide content from the air flow which flows through said second line for taking ambient air, in order to enable a zero-calibration for said second sensor means for sensing the carbon dioxide concentration,

a line which can be connected to a tank containing air of known composition, to enable automatic calibrations of the first and second sensor means for sensing the oxygen concentration and the carbon dioxide concentration.

4. Device according to claim 3, wherein each of said selector valves distributed in series along the calibration line has a switching element which can be moved between an active position, in which the selector valve communicates a respective auxiliary line to the calibration line and an inactive position in which the respective auxiliary line is isolated.

5. Device according to claim 1, wherein said first inlet of the selection valve is connected to said first inlet connector by a second sampling line through which a sampling portion is taken of the air flow exhaled by the subject who breathes spontaneously, said flow portion being introduced into said first inlet connector.

6. Device according to claim 5, wherein said second sampling line is connected to said first connector through:

a centrifugal pump which at its inlet takes the entire air flow which is introduced into the first inlet connector said centrifugal pump further including an outlet which is connected both to said second sampling line and to a discharged line adapted to discharge most part of the airflow which is exhaled by the subject which breathes spontaneously towards the outside,

a first turbine flowmeter for measuring the entire flow rate of the air exhaled by the subject who breathes spontaneously, a part of which reaches said first inlet of the selection valve.

7. Device according to claim 1, wherein said flow measuring means comprise:

a second disposable flowmeter or pneumotachograph which is to be interposed in a line which feeds air to a subject undergoing assisted pulmonary ventilation, said second flowmeter comprising two pressure probes at an inlet and an outlet of the second flowmeter, which are respectively connected to two inlets of a differential pressure transducer, for detecting the flow rate of the air flow through said second flowmeter.

8. Device according to claim 7, wherein said device includes two valves for automatic calibration of said second disposable flowmeter which are adapted to periodically communicate the two inlets of said differential pressure transducer to the atmosphere, so as to enable a zero-calibration of said transducer.

9. Device according to claim 6, wherein:

said first inlet connector of the device is adapted to be temporarily connected to the outlet of said second disposable flowmeter in a preliminary semi-automatic calibration stage of the second disposable flowmeter, and in that

said electronic controller is further programmed for performing said preliminary calibration of the second disposable flowmeter by activating said centrifugal pump for causing an air flow to be fed to said inlet connector through said second disposable flowmeter and by using a signal from said first turbine flowmeter for performing a set-up of the second disposable flowmeter.

10. Device according to claim 1, wherein said electronic controller is further programmed for receiving and processing signals coming from said first sensor means for sensing the oxygen concentration and from said second sensor means for sensing the carbon dioxide concentration during an operative stage with static flow, in which said switching valve is in a condition in which the connection of said suction pump to said first and second sensor means is interrupted, so that no dynamic flow occurs through the sensor means.

11. Device according to claim 1, wherein the device further comprises:

first humidity sensor means for sensing humidity of the air flow through the main line and

second humidity sensor means adapted to detect humidity of the ambient air,

said electronic controller being further programmed for comparing the humidity values measured by said first and second humidity sensor means and for activating an alarm signal when the difference between these values overcomes a predetermined threshold.

12. Method for the analysis of the air exhaled by a subject in order to measure basal metabolism of the subject with the use of the device according to claim 1, in which during the normal operation of the device said selection valve is switched so as to feed into the main line a sampling flow of the air exhaled by the subject who breathes spontaneously or by a subject which undergoes assisted pulmonary ventilation, said by-pass valve being in its position causing the air flow to pass through said mixing mini-chamber so that said electronic control unit is able to perform said processing in order to obtain said measurement of the oxygen consumption and the carbon dioxide production by the subject within a number of respiratory cycles,

wherein said method further comprises the step of starting automatically, upon switching on the device, a self-calibration stage of the device in which:

the second switching valve communicates said second inlet of said selection valve to said calibration line and the selection valve communicates its second inlet to said main line, so that the main line enters into communication with said calibration line,

in said self-calibration stage, the by-pass valve is in the position which causes said sampling flow of the air exhaled by the subject to flow through said by-pass line without passing through said mixing mini-chamber, so that the self-calibration stage can be performed immediately on the basis of the flow coming from said calibration line, without requiring a filling of said mixing mini-chamber.

13. Method for the analysis of the air exhaled by a subject in order to measure basal metabolism of the subject with the use of the device according to claim 6, wherein two valves are provided for automatic calibration of said second disposable flowmeter, which valves periodically communicate two inlets of said differential pressure transducer to the atmosphere, so as to enable a zero-calibration of said transducer.

14. Method for the analysis of the air exhaled by a subject in order to measure basal metabolism of the subject with the use of the device according to claim 6, wherein said second disposable flowmeter is temporarily connected with its outlet to said first inlet connector of the device in a preliminary semi-automatic calibration stage of the second disposable flowmeter, and in that said preliminary calibration of the second disposable flowmeter is performed by actuating said centrifugal pump in order to activate an air flow towards said inlet connector through said second disposable flowmeter and by using a signal coming from said first turbine flowmeter for performing a set-up of the second disposable flowmeter.