BREATH ANALYSIS SYSTEM

• US 20150377868A1
• Filed: 06/29/2015
• Published: 12/31/2015
• Est. Priority Date: 06/27/2014
• Status: Active Grant

• Current Assignee: Pulse Health LLC
• Original Assignee: Pulse Health LLC
• Inventors: Cooper, Steve, Andrews, Neal, Mahon, Maura, Dreilinger, Rachel, Barsic, David, Myler, Weston, Krauss, Martin, Herbst, Scot, Ingle, James, Thomas, Gerald, Myers, Rick, Young, Brian, Lara, Juven, Noll, Charles
• Granted Patent: US 9,494,495 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61B 2010/0087 Breath samples
• CPC Class Codes: A61B 5/0071 by measuring fluorescence emission
• 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 5/087 Measuring breath flow
• CPC Class Codes: G01D 11/24 Housings ; Casings for instruments
• CPC Class Codes: G01N 1/22 in the gaseous state specially adapted for biological material G01N33/497; measuring breath flow A61B5/087
• CPC Class Codes: G01N 2001/2244 Exhaled gas, e.g. alcohol detecting
• CPC Class Codes: G01N 2021/6482 Sample cells, cuvettes
• CPC Class Codes: G01N 2033/4975 other than oxygen, carbon dioxide or alcohol, e.g. organic vapours
• CPC Class Codes: G01N 21/6428 Measuring fluorescence of fluorescent products of reactions or of fluorochrome labelled reactive substances, e.g. measuring quenching effects, using measuring "optrodes" in vivo A61B5/00; immunoassay G01N33/53
• CPC Class Codes: G01N 21/645 Specially adapted constructive features of fluorimeters
• CPC Class Codes: G01N 2201/022 Casings
• CPC Class Codes: G01N 2201/062 LED's
• CPC Class Codes: G01N 2201/068 Optics, miscellaneous
• CPC Class Codes: G01N 33/497 of gaseous biological material, e.g. breath
• CPC Class Codes: G01N 33/4972 Determining alcohol content for vehicle safety devices B60K28/06
• CPC Class Codes: G01N 33/52 Use of compounds or compositions for colorimetric, spectrophotometric or fluorometric investigation, e.g. use of reagent paper and including single- and multilayer analytical elements immunological elements G01N33/54386; involving labelled immunochemicals G01N33/58; for haemoglobin or occult blood G01N33/72
• CPC Class Codes: G01N 33/64 involving ketones
• CPC Class Codes: Y10T 436/200833 Carbonyl, ether, aldehyde or ketone containing
• CPC Class Codes: Y10T 436/202499 Formaldehyde or acetone

Abstract

A breath analysis system that includes a handle assembly with an analysis cartridge on an upper end thereof. The handle includes a main body portion with a pressure opening and a pressure transducer therein. The analysis cartridge includes a main body portion with an upper portion that defines a breath chamber, a lower portion that defines a fluid chamber and a filter assembly that is movable between a breath capture position and an analysis position. The filter assembly has an opening defined therethrough. In the breath capture position, the opening partially defines the breath chamber and in the analysis position the opening partially defines the fluid chamber. The system also includes an analysis device with a case, a door, a controller that controls the motor and a fluorescence detection assembly and a rotation assembly positioned in the case interior. The rotation assembly includes a shroud with a funnel portion for receiving the analysis cartridge.

Claims

1. A breath analysis system comprising:

a breath capture assembly that includes

a handle assembly that includes an elongated main body portion that defines a handle interior, a pressure opening defined in an end of the elongated main body portion, and a pressure transducer disposed in the handle interior, and

an analysis cartridge received on an upper end of the handle assembly, wherein the analysis cartridge includes a main body portion that includes an upper portion that defines a breath chamber, and a lower portion that defines a fluid chamber, wherein the breath chamber includes a breath entry opening, a breath exit opening and a breath path therebetween, and a filter assembly that is movable along a filter assembly path between a breath capture position and an analysis position, wherein the filter assembly has an opening defined therethrough, and wherein in the breath capture position, the opening partially defines the breath chamber and is part of the breath path and in the analysis position the opening partially defines the fluid chamber, and

an analysis device that includes

a case defining a case interior,

a door movable between an open and closed position, and

a rotation assembly positioned in the case interior, the rotation assembly including a shroud that has a funnel portion defined therein for receiving the analysis cartridge, and

a controller that controls the motor and the fluorescence detection assembly; and

wherein the pressure transducer is in communication with the controller.

2. The breath analysis system of claim 1 wherein the analysis cartridge includes a phenylene diamine derivative disposed therein.

3. The breath analysis system of claim 2 wherein the phenylene diamine derivative is m-phenylene diamine.

4. The breath analysis system of claim 1 wherein the rotation assembly includes first and second fixed members, and a rotatable portion positioned between the first and second fixed members, wherein the rotatable portion is rotatable about a rotation axis with respect to the first and second fixed members, wherein the shroud is part of the rotatable portion, wherein the shroud includes a pocket opening defined at the top thereof, wherein the rotation assembly including a fluorescence detection assembly positioned generally below the shroud, and a motor that drives rotation of the rotatable portion.

5. The breath analysis system of claim 4 wherein the fluorescence detection assembly includes:

an emitter,

a detector,

a housing that defines an light chamber, a fluorescence chamber and a well,

a light path that extends from the emitter, through the light chamber and through the well, and

a fluorescence path that extends from the well, through the fluorescence chamber and to the detector.

6. The breath analysis system of claim 5 further comprising a first lens and a first filter positioned within the light path, and a second lens and a second filter positioned within the fluorescence path.

7. The breath analysis system of claim 6 further comprising a first light baffle positioned within the light path between the emitter and the first lens, wherein the first baffle includes a first light baffle aperture defined therein, and wherein the first light baffle aperture has a smaller inner diameter than an inner diameter of the light chamber.

8. The breath analysis system of claim 1 wherein the analysis device includes an arm that is pivotal between a stowed position and a deployed position, wherein the arm includes a first end that extends through an arm opening defined in the shroud when in the deployed position, wherein when the rotatable portion rotates from a start position to an insertion position the arm pivots from the stowed position to the deployed position.

9. The breath analysis system of claim 8 wherein the arm is biased toward the stowed position and includes a second end that is operationally associated with a cam surface on the second fixed member.

10. The breath analysis system of claim 9 wherein the cam surface has a stowed end that is associated with the stowed position of the arm and a deployed end that is associated with the deployed end of the arm, wherein the cam surface includes an increasing radius from the stowed end to the deployed end.

11. A method of detecting fluorescence, the method comprising the steps of:

(a) inserting an analysis cartridge into an analysis pocket, wherein the analysis cartridge includes a filter assembly that includes a substrate having a carbonyl containing moiety thereon;

(b) rotating the analysis cartridge from a start position to an insertion position,

(c) moving the filter assembly within the analysis cartridge from an upper chamber to a fluid chamber that contains an elution solution,

(d) rotating the analysis cartridge from the insertion position to an analysis position such that the elution solution drains through the filter assembly and the carbonyl containing moiety is eluted into the elution solution to form a fluorescing solution, and

(d) analyzing the fluorescence of the fluorescing solution.

12. The method of claim 11 wherein the analysis cartridge includes a main body portion that includes an upper portion that defines the upper chamber, and a lower portion that defines the fluid chamber, wherein the filter assembly has an opening defined therethrough, and wherein in the first position, the opening partially defines the upper chamber and in the second position the opening partially defines the fluid chamber.

13. The method of claim 12 wherein the filter assembly is movable within a cylindrical sleeve that extends from the upper chamber to the fluid chamber.

14. The method of claim 13 wherein the sleeve includes a top opening such that an upper surface of the filter assembly is exposed to an exterior of the main body portion.

15. The method of claim 12 wherein the filter assembly includes a cylindrically shaped filter holder that includes the opening extending transversely therethrough, and two filters positioned such that they span the opening, wherein the filters define a substrate space therebetween, and wherein a substrate is disposed in the substrate space.

16. The method of claim 14 wherein during step (b) an arm pivots from a stowed position to a deployed position, wherein a first end of the arm contacts the filter assembly through the top opening, and wherein the arm pushes the filter assembly from the upper chamber to the fluid chamber.

17. An analysis device comprising:

a case defining a case interior,

a door movable between an open and a closed position,

a rotation assembly positioned in the case interior, the rotation assembly including first and second fixed members, and a rotatable portion positioned between the first and second fixed members, wherein the rotatable portion is rotatable about a rotation axis with respect to the first and second fixed members, wherein the rotatable portion includes a shroud that has a funnel portion defined therein for receiving an object to be rotated, wherein the shroud includes a pocket opening defined at the top thereof, the rotation assembly including a fluorescence detection assembly positioned generally below the shroud, and a motor that drives rotation of the rotatable portion, and

a controller that controls the motor and the fluorescence detection assembly.

18. The analysis device of claim 17 wherein the shroud includes a pocket opening and an analysis opening opposite to one another, and wherein the shroud includes walls that taper between the pocket opening and the analysis opening.

19. The analysis device of claim 18 wherein the fluorescence detection assembly includes a housing that has an analysis cartridge receiving portion with a well defined therein, and wherein the well is aligned with the analysis opening in the shroud to form an analysis pocket.

20. The analysis device of claim 19 wherein the analysis cartridge receiving portion cooperates with the shroud to define a light entry aperture, a light exit aperture and a fluorescence aperture.

21. The analysis device of claim 20 wherein the fluorescence detection assembly includes a light that is configured to be directed along a light path that extends through a light chamber defined in the housing, through the light entry aperture, through the light exit aperture, and into a light trap.

22. The analysis device of claim 21 wherein the fluorescence detection assembly includes a detector for receiving fluorescence emitted through the fluorescence opening and through a fluorescence chamber defined in the housing.

23. The analysis device of claim 22 wherein the fluorescence chamber is generally orthogonal to the light chamber.

24. The analysis device of claim 17 further comprising an arm that is pivotal between a stowed position and a deployed position, wherein the arm includes a first end that extends through an arm opening defined in the shroud when in the deployed position, wherein when the rotatable portion rotates from a start position to an insertion position the arm pivots from the stowed position to the deployed position.

25. The analysis device of claim 24 wherein the arm is biased toward the stowed position and includes a second end that is operationally associated with a cam surface on the second fixed member.

26. The analysis device of claim 25 wherein the cam surface has a stowed end that is associated with the stowed position of the arm and a deployed end that is associated with the deployed end of the arm, wherein the cam surface includes an increasing radius from the stowed end to the deployed end.

27. The analysis device of claim 26 wherein the arm includes a ball bearing on the second end thereof, and wherein the ball bearing interacts with the cam surface.

28. The analysis device of claim 27 wherein the arm is pivotal on a shaft that extends from the shroud.

29. A method for detecting and quantifying a breath sample, the method comprising the steps of:

(a) providing an analysis cartridge,

(b) connecting the analysis cartridge to a handle assembly,

(c) collecting a breath sample including carbonyl containing moieties on a filter assembly,

(d) painting the breath sample to provide a painted solution,

(e) inserting the painted solution into an analysis device,

(f) directing light within a predetermined wavelength range through the painted solution, thereby producing a fluorescence,

(g) analyzing the fluorescence.

30. The method of claim 29 wherein the breath sample includes carbonyl containing moieties.