Method and device for collecting and analyzing exhaled breath

• US 7,118,537 B2
• Filed: 04/30/2001
• Issued: 10/10/2006
• Est. Priority Date: 04/30/2001
• Status: Active Grant

• Current Assignee: Respiratory Research, Inc.
• Original Assignee: Respiratory Research, Inc.
• Inventors: Baddour, Alfred R.
• Primary Examiner(s): Nasser, Robert L.
• Application Number:
  US10/257,912
• Publication Number:
  US 20030208132A1
• Time in Patent Office: 1,989 Days
• Field of Search: None
• US Class Current: 600/543
• 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

Abstract

A method and device for collecting, storing, shipping, preparing and analyzing condensate derived from the exhaled breath of a user. Using the mouthpiece (15) of the device (10), a human subject inhales drawing air through a check valve (30).

Claims

1. A method for collecting condensate from the breath of a subject inhaled through and exhaled into a portable device comprising a mouthpiece including a check valve optionally attached to a filter assembly further attached to the bottom end of a cooled, open-ended, hollow collecting tube close to the bottom end of which a hollow duckbill valve has been inserted so as to make a sealing connection with the interior walls thereof and for analyzing the collected condensate for the presence of one or more selected substances comprising:

sliding a cooling sleeve having a lower temperature than the collecting tube over the collecting tube and placing the cooling sleeve in at least close physical proximity with the collecting tube prior to giving the tube to the subject;

instructing the subject to inhale through the mouthpiece while ensuring by means of operation of the duckbill valve and a check valve located within the mouthpiece that air inhaled by the subject comes directly from a desired source and does not contaminate the collecting tube;

directing the subject to exhale through the mouthpiece while maintaining the collecting tube oriented approximately perpendicular to the ground;

channeling breath exhaled from the subject by means of closure of the check valve through the filter assembly, if there is one, and the duckbill valve turbulently into the collecting tube;

repeating returning to the instructing step until a period of approximately ten minutes has elapsed from the first inhalation;

removing the cooling sleeve from around the collecting tube and disconnecting the filter, if any, and mouthpiece assembly from the bottom end of the collecting tube;

pushing the duckbill valve along the length of the collecting tube to within approximately two inches of the top end thereof while maintaining the collecting tube oriented approximately perpendicular to the ground so as to wipe condensate from the interior walls of the collecting tube and form a pool of condensate around the base of the duckbill valve;

installing an airtight cap on the top end of the collecting tube if the tube is to be either stored for later use or shipped to another location for analysis;

moving the tube to the analysis site and removing the airtight cap, if one has been installed;

degassing the condensate pool; and

withdrawing a test sample of the condensate for analysis.

2. The method of claim 1 wherein withdrawing further comprises:

inserting a test probe through the open top end of the collecting tube;

advancing the test probe until it comes into contact with the condensate pool; and

removing the test probe from the collecting tube.

3. The method of claim 1 wherein injecting further comprises using a manual probe to inject the at least one preselected gas or liquid through the duckbill valve.

4. The method of claim 1 wherein degassing further comprises inserting one end of the collecting tube into a single positively pressurized manifold which forces gas into the bottom of the tube and allows it to exhaust to the atmosphere.

5. The method of claim 1 wherein degassing further comprises retainably placing the top and the bottom of the collecting tube into separate manifolds, subjecting both ends of the collecting tube to a mechanized vacuum and periodically exposing the bottom end of the collecting tube to the atmosphere.

6. The method of claim 5 wherein degassing further comprises removing the tube from retention between the two manifolds.

7. The method of claim 1 wherein degassing further comprises:

inserting a probe into the bottom end of the tube and advancing the probe until it comes into seated contact with the bottom of the duckbill valve while maintaining the tube oriented approximately perpendicular to the ground;

injecting at least one preselected gas or liquid under pressure through the duckbill valve into the condensate pool; and

permitting the preselected gas, if any, to bubble through the condensate and escape into the atmosphere through the open end of the collecting tube or the preselected liquid, if any, to mix with the condensate.

8. A method for collecting condensate from the breath of a subject exhaled into a cooled, hollow collecting tube close to one end of which a one-way valve for admitting breath into the tube has been inserted so as to make a sealing connection with the interior walls thereof comprising:

admitting exhaled breath into the collecting tube through the one-way valve;

causing turbulence in the exhaled breath as it is admitted into the collecting tube through the one-way valve to enhance condensation efficiency along the interior walls of the collecting tube;

moving the one-way valve towards the opposite end of the collecting tube to swipe condensate from the interior walls of the tube and to concentrate and pool the condensate within the collecting tube;

removing the pooled condensate from the collecting tube or assaying samples of the pooled condensate directly within the collecting tube, whichever is preferred.

9. The method of claim 8 wherein, instead of removing or assaying the pooled condensate, the method further comprises:

placing an airtight cap sealingly over the opposite end of the collecting tube; and

either storing the collecting tube in a cooling device at a temperature necessary to maintain the condensate or shipping the collecting tube to another location while maintaining the collecting tube at a temperature necessary to maintain the condensate, whichever is preferred.

10. The method of claim 8 wherein moving further comprises employing a piston and rod type plunger to exert force against the one-way valve to cause motion towards the opposite end of the collecting tube.

11. The method of claim 8 wherein the tube is either portable or disposable or both portable and disposable.

12. A method for collecting condensate from the breath of a subject exhaled into a cooled, hollow collecting tube close to one end of which a one-way valve for admitting breath into the tube has been inserted so as to make a sealing connection with the interior walls thereof comprising:

moving the one-way valve towards the opposite end of the collecting tube after a subject has exhaled through the one-way valve into the collecting tube to swipe condensate from the interior walls of the tube and to concentrate and pool the condensate within the collecting tube; and

removing the pooled condensate from the collecting tube or assaying samples of the pooled condensate directly from the collecting tube, whichever is preferred.

13. The method of claim 12 wherein the one-way valve is a duckbill valve.

14. The method of claim 12 wherein the tube is either portable or disposable or both portable and disposable.

15. A method for collecting breath condensate of a subject from an open-ended, hollow, cooled, collecting tube having a one-way valve situated at one end thereof comprising:

causing the subject to exhale into the collecting tube through the one-way valve and

swiping the interior walls of the collecting tube from one end to the opposite end thereof with the one-way valve wherein the one-way valve functions as a plunger.

16. The method of claim 15 wherein the plunger is a piston and rod.

17. The method of claim 15 wherein the tube is either portable or disposable or both portable and disposable.