CA2511218A1 - Disposable hand-held device for collection of exhaled breath condensate - Google Patents

Disposable hand-held device for collection of exhaled breath condensate Download PDF

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Publication number
CA2511218A1
CA2511218A1 CA002511218A CA2511218A CA2511218A1 CA 2511218 A1 CA2511218 A1 CA 2511218A1 CA 002511218 A CA002511218 A CA 002511218A CA 2511218 A CA2511218 A CA 2511218A CA 2511218 A1 CA2511218 A1 CA 2511218A1
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CA
Canada
Prior art keywords
central chamber
breath
condensate collection
breath condensate
collection apparatus
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Granted
Application number
CA002511218A
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French (fr)
Other versions
CA2511218C (en
Inventor
Jeffrey A. Kline
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Charlotte Mecklenburg Hospital
Original Assignee
The Charlotte-Mecklenburg Hospital Authority
Jeffrey A. Kline
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Application filed by The Charlotte-Mecklenburg Hospital Authority, Jeffrey A. Kline filed Critical The Charlotte-Mecklenburg Hospital Authority
Publication of CA2511218A1 publication Critical patent/CA2511218A1/en
Application granted granted Critical
Publication of CA2511218C publication Critical patent/CA2511218C/en
Anticipated expiration legal-status Critical
Expired - Fee Related legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/08—Detecting, measuring or recording devices for evaluating the respiratory organs
    • A61B5/097—Devices for facilitating collection of breath or for directing breath into or through measuring devices
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00—Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
    • A61B2010/0083—Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements for taking gas samples
    • A61B2010/0087—Breath samples

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Biomedical Technology (AREA)
  • Molecular Biology (AREA)
  • Pulmonology (AREA)
  • Biophysics (AREA)
  • Pathology (AREA)
  • Engineering & Computer Science (AREA)
  • Physiology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Medical Informatics (AREA)
  • Physics & Mathematics (AREA)
  • Surgery (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Sampling And Sample Adjustment (AREA)
  • Investigating Or Analysing Biological Materials (AREA)

Abstract

A breath condensate collection apparatus (10) comprising a central chamber (24), a breath input assembly (50), a plunger assembly (30) and a breath condensate collection port (39). The central chamber has inner (22) and outer (32) side walls with a coolant material (34) sealed in between. The breath input assembly (50) is disposed on the side of the central chamber (24) in fluid communication with the interior of the chamber. Obstructive structures may be arranged in the chamber interior for increasing the surface area on which condensate may form. The apparatus may also include an outlet assembly that may be removed and replaced with a sampling well into which the condensate may be washed with a buffer solution.

Claims (50)

1. A breath condensate collection apparatus comprising:

a central chamber having double side walls and first and second opposing ends, wherein the double side walls include an inner side wall and an outer side wall in spaced relationship to one another;

a coolant material sealed between the inner and outer side walls for cooling at least the inner walls of the central chamber;

a breath input assembly disposed on the outside of the outer side wall of the central chamber and penetrating both the inner and outer side walls such that the interior of the breath input assembly is in fluid communication with the interior of the central chamber;

a plunger assembly having a piston and a handle, wherein the piston is slidably disposed in the interior of the central chamber in snug contact with the inner side wall and wherein the handle extends from the first end of the central chamber so as to permit the piston to be moved within the central chamber; and a breath condensate collection port, disposed at the second end of the central chamber, in fluid communication with the interior of the central chamber.
2. The breath condensate collection apparatus of Claim 1, wherein the plunger assembly is adjustable between a fully retracted position and a fully depressed position, and wherein when the plunger is in its fully retracted position, the fluid connection between the breath input assembly and the central chamber lies in between the piston and the second end of the central chamber.
3. The breath condensate collection apparatus of Claim 2, wherein the location of the breath input assembly on the outside of the outer side wall of the central chamber is adjacent the first end of the central chamber.
4. The breath condensate collection apparatus of Claim 3, wherein the location of the breath input assembly is underneath the central chamber.
5. The breath condensate collection apparatus of Claim 3, wherein the central chamber includes an end wall at the second end thereof, and wherein the breath condensate collection port is disposed in the end wall of the central chamber.
6. The breath condensate collection apparatus of Claim 5, wherein the piston includes a surface facing toward the second end of the central chamber, wherein a protrusion is disposed on the surface of the piston, and wherein the protrusion is adapted to fit into the breath condensate collection port when the plunger assembly is fully depressed into the central chamber.
7. The breath condensate collection apparatus of Claim 6, wherein the breath condensate collection port and the protrusion are each semi-conical in shape.
8. The breath condensate collection apparatus of Claim 6, wherein one or more grooves are disposed in the sides of the protrusion to facilitate guiding breath condensate toward the breath condensate collection port.
9. The breath condensate collection apparatus of Claim 6, wherein one or more internal passages are disposed in the interior of the protrusion to facilitate guiding breath condensate toward the breath condensate collection port.
10. The breath condensate collection apparatus of Claim 9, further comprising a rigid, hollow tube structure extending from one of the internal passages through which fluid from the interior of the protrusion may be directed.
11. The breath condensate collection apparatus of Claim 2, wherein the breath condensate collection port is disposed on the outside of the outer side wall of the central chamber adjacent the second end thereof.
12. The breath condensate collection apparatus of Claim 11, wherein the breath condensate collection port is disposed on the bottom of the central chamber, the breath condensate collection apparatus further comprising an outlet and an outlet valve disposed on the top of the outer side wall of the central chamber adjacent the second end thereof.
13. The breath condensate collection apparatus of Claim 12, further comprising a cap for temporarily sealing the breath condensate collection port.
14. The breath condensate collection apparatus of Claim 2, wherein the breath condensate collection apparatus, defines a main axis, wherein the breath input assembly includes a mouthpiece and a tube structure connecting the mouthpiece to the side of the central chamber, and wherein the mouthpiece is generally oriented in parallel to the main axis of the breath condensate collection apparatus.
15. The breath condensate collection apparatus of Claim 2, further comprising at least one clip, mounted at the first end of the central chamber, for locking the handle of the plunger assembly in a fully depressed position to facilitate transport or handling of the breath condensate collection apparatus until breath condensate collected therein may be removed.
16. A method of collecting breath condensate, the method comprising:
providing a central chamber having double side walls, first and second opposing ends, a coolant material sealed between the inner and outer side walls for cooling at least the inner walls of the central chamber, and a breath condensate collection port disposed at the second end of the central chamber;
lowering the temperature of the coolant material to chill at least the inner walls of the central chamber;
receiving, in the interior of the central chamber, exhaled breath from a patient, delivered through the inner and outer side walls via a breath input assembly disposed on the outside of the outer side wall of the central chamber;
condensing portions of the exhaled breath on the inner surfaces of the inner walls of the central chamber;
expressing condensate, produced during the condensing step, from the central chamber by depressing a plunger assembly through the central chamber, thereby forcing the condensate into the breath condensate collection port; and aspirating the expressed condensate from the breath condensate collection port for analysis thereof.
17. The method of Claim 16, wherein the aspirating step includes aspirating the expressed condensate into a pipette, the method further comprising:
transferring the condensate from the pipette to a separate assay well for analysis thereof.
18. The method of Claim 17, wherein providing a central chamber includes providing a central chamber having an outlet and outlet valve disposed on the top of the outer side wall of the central chamber adjacent the second end thereof and the breath condensate collection port disposed on the bottom of the central chamber, the method further comprising:
temporarily sealing the breath condensate collection port during the receiving and condensing steps.
19. The method of Claim 17, wherein providing a central chamber includes providing a central chamber having at least one clip mounted at the first end of the central chamber, the method further comprising:
after expressing the condensate by depressing the plunger assembly, locking, via the at least one clip, the handle of the plunger assembly in a fully depressed position to facilitate transport or handling of the breath condensate collection apparatus until aspirating the expressed condensate.
20. The method of Claim 17, wherein receiving exhaled breath includes receiving the exhaled breath delivered through the inner and outer side walls via a breath input assembly disposed underneath the central chamber.
21. A breath condensate collection apparatus comprising:
a central chamber having double side walls including an inner side wall and an outer side wall in spaced relationship to one another;
a coolant material sealed between the inner and outer side walls for cooling at least the inner walls of the central chamber;

a breath input assembly, the interior of which is in fluid communication with the interior of the central chamber;
one or more obstructive structures arranged in the interior of the central chamber for increasing the surface area on which condensate may form; and a breath condensate collection port in fluid communication with the interior of the central chamber.
22. The breath condensate collection apparatus of Claim 21, wherein the obstructive structures include grid-like structures.
23. The breath condensate collection apparatus of Claim 21, wherein the obstructive structures include discrete geometric structures.
24. The breath condensate collection apparatus of Claim 23, wherein the discrete geometric structures include spherical objects.
25. The breath condensate collection apparatus of Claim 23, wherein the discrete geometric structures are formed from metal.
26. The breath condensate collection apparatus of Claim 23, wherein the discrete geometric structures are formed from glass.
27. The breath condensate collection apparatus of Claim 21, wherein the obstructive structures are fixed in place within the interior of the central chamber.
28. The breath condensate collection apparatus of Claim 21, wherein the obstructive structures are free-floating within the interior of the central chamber.
29. The breath condensate collection apparatus of Claim 28, wherein movement of the obstructive structures is restricted to a particular portion of the central chamber.
30. The breath condensate collection apparatus of Claim 21, wherein the location of the breath input assembly is underneath the central chamber.
31. A method of collecting breath condensate, the method comprising:
providing a double-walled central chamber having one or more obstructive structures arranged in the interior thereof and a coolant material sealed between the inner and outer side walls for cooling at least the inner walls of the central chamber;
lowering the temperature of the coolant material to chill at least the inner walls of the central chamber and the obstructive structures;
receiving, in the interior of the central chamber, exhaled breath from a patient;
condensing portions of the exhaled breath on the inner surfaces of the inner walls of the central chamber and on the obstructive structures; and removing condensate, produced during the condensing step, from the central chamber.
32. The method of Claim 31, wherein the removing step includes washing the condensate from the obstructive structures.
33. The method of Claim 32, wherein the washing step includes adding an amount of liquid to the central chamber, wherein the amount is selected to correspond to the amount of condensate present in the central chamber.
34. The method of Claim 32, wherein the washing step includes adding an amount of liquid to the central chamber, wherein the amount is selected to correspond to the amount of condensate likely to be present in the central chamber after the patient exhales into the central chamber for a predetermined period of time.
35. The method of Claim 32, wherein the washing step includes adding an amount of liquid to the central chamber, wherein the amount is selected to correspond to the amount of condensate likely to be present in the central chamber after the patient completes a predetermined number of exhalations into the central chamber.
36. The method of Claim 32, further comprising the step of removing the obstructive structures from the central chamber before carrying out the washing step.
37. A method of collecting breath condensate, the method comprising:
providing a double-walled central chamber having a removable outlet assembly and a coolant material sealed between the inner and outer side walls for cooling at least the inner walls of the central chamber;
lowering the temperature of the coolant material to chill at least the inner walls of the central chamber;
receiving, in the interior of the central chamber, exhaled breath from a patient;
condensing portions of the exhaled breath on the inner surfaces of the inner walls of the central chamber;
removing the outlet assembly and replacing it with a sampling well; and moving condensate, produced during the condensing step, from the central chamber to the sampling well.
38. The method of Claim 37, wherein the step of moving condensate includes washing condensate from the central chamber into the sampling well with a known liquid.
39. The method of Claim 38, wherein the step of washing condensate includes:
introducing a predetermined quantity of the known liquid into the central chamber;
mixing the predetermined quantity of the known liquid with the condensate; and draining the known liquid and the condensate from the central chamber into the sampling well.
40. The method of Claim 39, wherein the step of removing the outlet assembly includes creating an opening into the central chamber, and wherein the step of introducing includes introducing the known liquid through the opening.
41. The method of Claim 39, further comprising:
before replacing the outlet assembly with the sampling well, storing the known liquid in the sampling well.
42. The method of Claim 38, wherein the known liquid is a buffer solution.
43. The method of Claim 42, wherein the buffer solution is distilled water.
44. The method of Claim 42, wherein the buffer solution includes an organic dye to indicate the pH of the solution.
45. The method of Claim 38, further comprising:
before replacing the outlet assembly with the sampling well, storing the known liquid in the sampling well.
46. The method of Claim 38, further comprising:
before replacing the outlet assembly with the sampling well, storing the known liquid in the sampling well.
47. A method of collecting breath condensate, the method comprising:
providing a double-walled central chamber having one or more obstructive structures arranged in the interior thereof and a coolant material sealed between the inner and outer side walls for cooling at least the inner walls of the central chamber;
calibrating the walls and coolant material of the double-walled central chamber such that, when beginning at a predetermined temperature, a chosen number of breaths, received from a typical patient, creates a sufficient amount of breath condensate to be collected on the inner surfaces of the inner walls of the central chamber;
lowering the temperature of the coolant material to the predetermined temperature to chill at least the inner walls of the central chamber;
receiving, in the interior of the central chamber, a plurality of exhalations from a particular patient, wherein the number of exhalations is within a predetermined range established on the basis of the chosen number of breaths;
condensing portions of the exhalations, received from the patient, on the inner surfaces of the inner walls of the central chamber; and removing condensate, produced during the condensing step, from the central chamber.
48. The method of Claim 47, wherein the predetermined range is 10 to 25 breaths, inclusive.
49. The method of Claim 47, wherein the predetermined temperature is the temperature of a standard freezer.
50. The method of Claim 49, wherein the predetermined temperature is 0°
F.
CA2511218A 2002-12-20 2003-12-19 Disposable hand-held device for collection of exhaled breath condensate Expired - Fee Related CA2511218C (en)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US43491602P 2002-12-20 2002-12-20
US60/434,916 2002-12-20
US44758103P 2003-02-14 2003-02-14
US60/447,581 2003-02-14
PCT/US2003/041209 WO2004058125A2 (en) 2002-12-20 2003-12-19 Disposable hand-held device for collection of exhaled breath condensate

Publications (2)

Publication Number Publication Date
CA2511218A1 true CA2511218A1 (en) 2004-07-15
CA2511218C CA2511218C (en) 2012-06-05

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CA2511218A Expired - Fee Related CA2511218C (en) 2002-12-20 2003-12-19 Disposable hand-held device for collection of exhaled breath condensate

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US (3) US20040138577A1 (en)
EP (1) EP1571985B1 (en)
JP (1) JP4299837B2 (en)
AT (1) ATE427068T1 (en)
AU (1) AU2003300356A1 (en)
BR (1) BR0316872B1 (en)
CA (1) CA2511218C (en)
DE (1) DE60326988D1 (en)
HK (1) HK1083733A1 (en)
WO (1) WO2004058125A2 (en)

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AU2003300356A8 (en) 2004-07-22
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US20130197388A1 (en) 2013-08-01
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AU2003300356A1 (en) 2004-07-22
US8491494B2 (en) 2013-07-23
EP1571985A4 (en) 2008-02-27
HK1083733A1 (en) 2006-07-14
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ATE427068T1 (en) 2009-04-15
JP2006511824A (en) 2006-04-06

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