Flow regulation device for breath analysis and related method

• US 10,226,201 B2
• Filed: 10/31/2016
• Issued: 03/12/2019
• Est. Priority Date: 10/29/2015
• Status: Active Grant

• Current Assignee: Invoy Holdings, Inc.
• Original Assignee: Invoy Holdings, LLC
• Inventors: Ahmad, Lubna M., Smith, Zachary, Ahmad, Salman A.
• Primary Examiner(s): Agahi, Puya
• Application Number:
  US15/339,870
• Publication Number:
  US 20170119279A1
• Time in Patent Office: 862 Days
• CPC Class Codes: A61B 10/00 Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis vaccination prophylaxis, vaccination therapy A61B17/20; Sex determination; Ovulation-period determination menstruation tables G06C3/00; Throat striking implements
• CPC Class Codes: A61B 2010/0087 Breath samples
• CPC Class Codes: A61B 2562/0233 Special features of optical sensors or probes classified in A61B5/00
• CPC Class Codes: A61B 5/01 Measuring temperature of body parts ; Diagnostic temperature sensing, e.g. for malignant or inflamed tissue clinical contact thermometers G01K13/20
• CPC Class Codes: A61B 5/0803 Recording apparatus specially adapted therefor
• CPC Class Codes: A61B 5/082 Evaluation by breath analysis, e.g. determination of the chemical composition of exhaled breath A61B5/083, A61B5/091 take precedence
• CPC Class Codes: A61B 5/0823 Detecting or evaluating cough events
• 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 5/0873 using optical means
• CPC Class Codes: A61B 5/0878 using temperature sensing means
• CPC Class Codes: A61B 5/091 Measuring volume of inspired or expired gases, e.g. to determine lung capacity
• CPC Class Codes: A61B 5/097 Devices for facilitating collection of breath or for directing breath into or through measuring devices
• CPC Class Codes: A61B 5/74 Details of notification to user or communication with user or patient indicating measured values G01D7/00; user input means input or output arrangements for computers G06F3/00

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.

Claims

1. A breath analyte capture and analysis system for determining a concentration of an analyte in a breath sample from a user, comprising:

a cartridge having a chamber containing an interactant material;

a mouthpiece device configured to receive and fluidly connect to the cartridge, the mouthpiece device configured to enable the user to exhale a portion of the breath sample through the chamber such that the portion passes through the interactant material under an exhalation force created by the user, causing the interactant material to absorb the analyte, the mouthpiece device comprising;

an influent flow port into which the user exhales the breath sample;

a first flow path coupled to the influent flow port, the first flow path extending into the chamber when the cartridge is positioned in the mouthpiece device;

a second flow path coupled to the influent flow port; and

a valve that is manually switchable by the user, by application of a depressive force by the user, between a first orientation in which breath entering the influent port travels through the second flow path and a second orientation in which breath entering the influent port travels through the first flow path, the valve enabling the user to manually route the portion of the breath sample exhaled into the mouthpiece device through the chamber of the cartridge to cause the portion to be exposed to the interactant material; and

a base unit configured to receive and analyze the cartridge after the portion of the breath sample has been routed through the chamber of the cartridge using the mouthpiece device, the base unit comprising a sensor that senses the concentration of the analyte in the portion of the breath sample, wherein the base unit is physically separate from the mouthpiece device such that the user can exhale the portion of the breath sample into the mouthpiece device and cartridge at a location that is remote from the base unit.

2. The system of claim 1, wherein the valve is manually switchable by the user by depression of a button.

3. The system of claim 1, further comprising a signal generation device that provides a signal to the user during exhalation, the signal indicating to the user when to apply the depressive force.

4. The system of claim 3, wherein the signal generation device is configured to provide the signal a selected time interval prior to a desired valve actuation time to account for human delay in applying the depressive force.

5. The system of claim 3, further comprising a timer that controls a timing with which the signal generation device generates the signal relative to initiation of exhalation.

6. The system of claim 1, wherein the base unit is configured to dispense a developer solution into the cartridge.

7. The system of claim 1, wherein the second flow path is an exhaust path that exhausts from the mouthpiece device a second portion of the breath sample.

8. The system of claim 1, wherein the cartridge comprises multiple chambers for receiving multiple breath samples, each chamber containing an interactant material, the cartridge being movable between multiple inserted positions in the mouthpiece device, each of the multiple positions corresponding to a different respective one of the chambers.

9. The system of claim 1, wherein the cartridge comprises a memory, and the mouthpiece device is configured to store in the memory a timestamp corresponding to a time at which a breath sample was exhaled into the cartridge.

10. The system of claim 1, wherein the sensor senses the concentration by sensing a color change produced in the chamber by a chemical reaction.

11. A method of analyzing breath, comprising:

with a portable mouthpiece device configured to receive a cartridge having a chamber containing an interactant material, routing a selected portion of a breath sample of a user through the chamber of the cartridge as the user exhales the breath sample into the mouthpiece device such that an exhalation force created by the user forces the selected portion of the breath sample through the chamber, causing the interactant material to absorb an analyte in the selected portion of the breath sample, wherein routing the selected portion comprises actuating a valve of the mouthpiece device; and

subsequently, after the cartridge has been removed from the mouthpiece device and inserted into a base unit that is physically separate from the mouthpiece device, generating a measurement of a concentration of the analyte in the selected portion of the breath sample, wherein generating the measurement comprises analyzing the cartridge with a sensor of the base unit.

12. The method of claim 11, wherein the valve is actuated in response to application of a depressive force by the user.

13. The method of claim 12, further comprising, by the mouthpiece device, generating a signal that notifies the user of a timing with which to apply the depressive force.

14. The method of claim 11, wherein the valve is actuated by a programmed controller.

15. The method of claim 14, wherein actuating the valve comprises, by the programmed controller, using valve control data to control a timing of valve actuation, the valve control data being based on one or more characteristics of the user such that operation of the valve is customized for the user.

16. The method of claim 15, further comprising generating the valve control data based on one or more measured breathing characteristics of the user.

17. The method of claim 14, wherein actuating the valve comprises, by the programmed controller, determining when to actuate the valve based on one or more sensed characteristics of the exhaled breath sample.

18. The method of claim 11, further comprising, by a controller of the mouthpiece device, storing in a memory of the cartridge a timestamp corresponding to a time at which the breath sample was exhaled into the mouthpiece.

19. The method of claim 11, wherein generating the measurement comprises measuring, with the sensor of the base unit, a color produced by a chemical reaction in the cartridge.

20. The method of claim 11, further comprising, by the base unit, dispensing a developer solution into the cartridge.

21. A breath analyte capture and analysis system capable of determining a concentration of an analyte in breath of a user, the system comprising:

a disposable cartridge having a test chamber containing an interactant material;

a portable mouthpiece device configured to receive and fluidly connect to the disposable cartridge, the portable mouthpiece device configured to route a portion of a breath sample, exhaled into the portable mouthpiece device by the user, through the test chamber such that the portion passes through the test chamber and interactant material under an exhalation force created by the user, causing the interactant material to absorb the analyte, the portable mouthpiece device further configured to route an additional portion of the breath sample out of the portable mouthpiece device such that the additional portion does not pass through the test chamber; and

a base unit configured to receive and analyze the disposable cartridge after the portion of the breath sample has been routed through the test chamber of the disposable cartridge using the portable mouthpiece device, the base unit comprising a sensor that senses a color change produced by a reaction in the test chamber, the color change indicative of a concentration level of the analyte;

wherein the base unit is physically separate from the portable mouthpiece device such that the user can exhale the portion of the breath sample into the portable mouthpiece device and disposable cartridge while located remotely from the base unit.

22. The system of claim 21, wherein the base unit is configured to dispense, into the disposable cartridge, a developer solution that reacts with the analyte to produce the color change.

23. The system of claim 21, wherein the disposable cartridge additionally includes a desiccant.

24. The system of claim 21, wherein the mouthpiece device comprises a valve that is manually switchable by the user by depression of a button of the mouthpiece device, wherein a position of the valve controls a routing of breath exhaled into the mouthpiece device.

25. The system of claim 21, wherein the portable mouthpiece device is a handheld device.