(19)
(11)EP 3 202 321 B1

(12)EUROPEAN PATENT SPECIFICATION

(45)Mention of the grant of the patent:
11.12.2019 Bulletin 2019/50

(21)Application number: 17154042.0

(22)Date of filing:  31.01.2017
(51)International Patent Classification (IPC): 
A61B 5/097(2006.01)

(54)

BREATH TESTING APPARATUS

ATEMPRÜFVORRICHTUNG

APPAREIL DE TEST RESPIRATOIRE


(84)Designated Contracting States:
AL AT BE BG CH CY CZ DE DK EE ES FI FR GB GR HR HU IE IS IT LI LT LU LV MC MK MT NL NO PL PT RO RS SE SI SK SM TR
Designated Extension States:
BA ME

(30)Priority: 03.02.2016 US 201615014205

(43)Date of publication of application:
09.08.2017 Bulletin 2017/32

(73)Proprietor: QuinTron Instrument Company, Inc.
Milwaukee, WI 53215 (US)

(72)Inventor:
  • Hamilton, Eric Lyle
    South Milwaukee, WI 53172 (US)

(74)Representative: Potter Clarkson 
The Belgrave Centre Talbot Street
Nottingham NG1 5GG
Nottingham NG1 5GG (GB)


(56)References cited: : 
WO-A2-2006/007180
US-A- 3 437 449
US-A- 5 465 728
GB-A- 2 064 324
US-A- 3 858 573
US-A1- 2012 226 183
  
      
    Note: Within nine months from the publication of the mention of the grant of the European patent, any person may give notice to the European Patent Office of opposition to the European patent granted. Notice of opposition shall be filed in a written reasoned statement. It shall not be deemed to have been filed until the opposition fee has been paid. (Art. 99(1) European Patent Convention).


    Description

    Background of the Invention



    [0001] This invention relates to the field of sampling air from the lungs and specifically to the field of obtaining a sample of a person's air, including alveolar air from the alveoli of the lungs of a person.

    [0002] Air from the lungs of a person can be used for many different types of testing that would otherwise require the person to undergo an invasive procedure. For example, alveolar air can be analyzed for, but not limited to, the noninvasive diagnosis of a wide variety of conditions including the noninvasive diagnosis of stomach infections related to a high incidence of ulcers, enzymatic deficiencies, and metabolic conditions and/or abnormalities. Crucial to any such testing is the ability to get an accurate sample containing a sufficient volume of air representative of true alveolar air, necessary for specific testing.

    [0003] Hydrogen and methane are produced in the digestive system primarily only by the bacterial fermentation of carbohydrates (sugars, starches or vegetable fibers), so either of these gases appear in the expired air, it is usually a signal that carbohydrates or carbohydrate fragments have been exposed to bacteria, permitting such fermentation to take place. Levitt, M.D. Production and excretion of hydrogen gas in man. New Engl. J. Med 1968; 281:122. The generation of H2 and/or CH4 will result in the reabsorption of some of these gases into the blood stream from the site of their digestion, and they will appear in the expired air.

    [0004] Bacteria are ordinarily not present in significant numbers in the small intestine, where digestion and absorption of sugars take place. Therefore, when a challenge dose (eg. lactose) is ingested, the level of hydrogen in alveolar air will rise significantly within one to two hours (depending on the intestinal transit time) only if the sugar is not digested and, therefore reaches the colon.

    [0005] The breath-H2 test is a simple non-invasive procedure which is readily accepted by patients and staff (Metz, G.; Jenkins, D.L.; Peters, T.J,; Newman, A.; Blendis, L.M. Breath hydrogen as a diagnostic method for hypolactasia. Lancet. 1975; 1(7917):1155-7 and which has greater reliability and acceptability than the blood test, according to most reports in the literature (DiPalma, J.A.; Narvaez, R.M. Prediction of lactose malabsorption in referral patients. Dig Dis Sci. 1988; 33:303 and Davidson, G.P.; Robb, T.A.. Value of breath hydrogen analysis in management of diarrheal illness in childhood: Comparison with duodenal biopsy. J Ped Gastroenterol Nutr. 1985; 4:381-7; Fernandes, J.; Vos, C.E.; Douwes, A. C.; Slotema, E.; Degenhart, H.J. Respiratory hydrogen excretion as a parameter for lactose malabsorption in children. Amer J Clin Nutr. 1978; 31:597-602; Newcomer, A.D.; McGill, D.B.; Thomas, R.J.; Hofmann, A.F. Prospective comparison of indirect methods for detecting lactase deficiency. New Engl J Med. 1975; 293:1232-6; Douwes, A.C.; Fernandes, J.; Degenhart H.J. Improved accuracy of lactose tolerance test in children, using expired H2 measurement. Arch Dis Child. 1978; 53:939-42; Solomons, N.W.; Garcia-Ibanez, R.; Viteri, F.E. Hydrogen breath test of lactose absorption in adults: The application of physiological doses and whole cow's milk sources. Amer J Clin Nutr. 1980; 33:545-54.

    [0006] The lower dose of lactose usually does not cause the discomfort and explosive diarrhea frequently seen by malabsorbers who are given the large dose required for the blood test.

    [0007] A study with over 300 patients showed that G-I symptoms after a lactose challenge are strongly associated with the amount of H2 excreted, and the relationship between blood glucose change and symptom-severity was less evident. Jones, D.V.; Latham, M.C.; Kosikowski, F.V.; Woodward, G. Symptom response to lactosereduced milk in lactose-intolerant adults. Amer J Clin Nutr. 1976; 29(6):633-8.

    [0008] False-positive breath-tests are rare, and when they occur they are usually caused by improperly doing the test - allowing the subject to smoke, to sleep or to eat shortly before or during the test11. Bacterial overgrowth (from the colon retrograde into the small intestine) can also produce a false-positive breath-test, but it is usually preceded by an elevated fasting breath-H2 level and the response is seen soon after the sugar is ingested (within 20-30 minutes).

    [0009] The incidence of false-negative results with the breath-test is well below that seen with the blood test. False-negative results are reported to be from 5-15% of all lactose malabsorbers. Filali, A.; Ben Hassine, L.; Dhouib, H.; Matri, S.; Ben Ammar, A.; Garoui, H. Study of malabsorption of lactose by the hydrogen breath test in a population of 70 Tunisian adults. Gastroenterol Clin Biol. 1987; 11:554-7; Douwes, A.C.; Schaap, C.; van der Kleivan Moorsel, J.M. Hydrogen breath test in school children. Arch Dis Child.1985; 60:333-7; Rogerro, P.; Offredi, M.L..; Mosca, F.; Perazzani, M.; Mangiaterra, V.; Ghislanzoni, P.; Marenghi, L.; Careddu, P. Lactose absorption and malabsorption in healthy Italian children: Do the quantity of malabsorbed sugar and the small bowel transit time play roles in symptom production? J Pediatr Gastroenterol Nutr.1985 (Feb); 4(1):82-614. This is due to a variety of causes. Many of the false-negative reports can be avoided by measuring methane in addition to hydrogen because some methanogenic flora convert colonic H2 to CH4. Cloarac, D.; Bornet, F.; Gouilloud, S.; Barry, J.Ll.; Salim, B.; Galmiche, J.P. Breath hydrogen response to lactulose in healthy subjects: relationship to methane producing status. Gut. 1990 (Mar); 31:300-4.

    [0010] US 3,858,573 discloses a breath collection apparatus having a mouthpiece, a tubular breath collection chamber leading from the mouthpiece which has a check valve at either end and a sampling valve assembly which is mounted on the breath collection chamber for collecting samples from the breath collection chamber.

    [0011] US 5,465,728 discloses a breath collection apparatus having a mouthpiece and a tubular breath collection chamber leading from the mouthpiece. The breath collection chamber has a breath exit portal fitted with a spring action flap valve and a sampling container is mounted on the breath collection chamber for collecting samples from that chamber under the control of a valve which may be operated manually or by a solenoid.

    [0012] WO 2006/007180 discloses a breath collection device for sampling breath condensate.

    Summary of the Invention



    [0013] In accordance with the present invention, a breath collection apparatus according to claim 1 is provided. A breath collection apparatus comprising a breath entryway or mouthpiece is coupled to a first one-way coupling, which is preferably, but not necessarily, a flutter valve. Breath is expelled into the mouthpiece and through the one-way coupling. A collection chamber is coupled to said breath entryway by said first one-way coupling, and a second one-way coupling, also which is preferably, but not necessarily, a flutter valve coupled to said collection chamber to allow a first waste portion of exhaled breath to escape the collection chamber. When the breath is completed, both one-way couplings will close, trapping an end-expiration breath sample within the collection chamber. A sample transfer assembly coupled to said collection chamber allows for an evacuated air chamber to be selectively coupled to said sample transfer assembly, and the evacuated air chamber recovers a portion of the end-expiration breath sample within the collection chamber. A discharge chute is coupled to said collection chamber about said sample transfer assembly, said discharge chute comprising a proximal end for coupling to said collection chamber, and a distal end for receiving said evacuated air chamber.

    Brief Description of the Drawings



    [0014] 

    Fig. 1 is a perspective view of a sample collection apparatus of the present invention, with an evacuated air chamber inserted into a distal end of a discharge chute.

    Fig. 2 is an exploded perspective view of a sample collection apparatus of the present invention.

    Fig. 3 is an in-use side cross-sectional view of a sample collection apparatus, shown collecting a breath sample;

    Fig. 4 is a side cross-sectional view of a sample collection apparatus, with an evacuated air chamber being inserted into a distal end of the discharge chute;

    Fig. 5 is a side cross-sectional view of a sample collection apparatus, with an evacuated air chamber being inserted onto a discharge needle within the discharge chute;

    Fig. 6 shows a collected an end-expiration breath sample.


    Description of the Preferred Embodiment



    [0015] Although the disclosure hereof is detailed and exact to enable those skilled in the art to practice the invention, the physical embodiments herein disclosed merely exemplify the invention which may be embodied in other specific structures. While the preferred embodiment has been described, the details may be changed without departing from the scope of the invention which is defined in the claims.

    [0016] Referring now to Fig. 1 a perspective view of a sample collection apparatus 10 of the present invention is shown. A mouthpiece 12 comprising a breath entryway is shown, to allow breath to pass to collection chamber 14. A breath discharge chute 16 receives an evacuated air chamber 100 that receives an end-expiration breath sample (described later) from within the collection chamber 14.

    [0017] Referring now to Fig. 2, an exploded perspective view of a sample collection apparatus 10 of the present invention is shown. Mouthpiece 12 is either integrally formed or coupled with a one-way discharge assembly 26. Positive pressure from a breath, through the mouthpiece 12, causes flexible ring 24 to flex, and allow air to pass into collection chamber 14 at an upstream end of collection chamber 14. Flexible ring 24, is preferably, but not necessarily, a flutter valve. Another one-way discharge structure 26, again coupled to a flexible ring 24 (and again preferably, but not necessarily, a flutter valve), is coupled to a downstream end of collection chamber 14. Coupled to the interior of collection chamber 14 is discharge needle 22, which provides a selective passageway from breath between collection chamber 14 and ultimately evacuated air chamber 100, which is coupled to discharge needle 22 through discharge chute 16.

    [0018] Referring now to Fig. 3, an in-use side cross-sectional view of sample collection apparatus 10 is shown. A patient has pressed a mouth to mouthpiece 12 and began exhalation. The first volume of breath 42 evacuates background air from within collection chamber 14, and first volume of breath 42, being not the most desirable for alveolar air sampling, is expelled through discharge chute 16 without capture. Positive pressure from the breath sample flexes flexible rings 24, allowing air to continue to flow through collection chamber 14, into discharge chute 16.

    [0019] As the breath stops, the positive pressure from the breathing stops as well, allowing flexible rings 24 to return to their static position, flush against one-way discharge structures 26 at the upstream and downstream ends of collection chamber 14. As the flexible rings 24 seal the collection chamber 14, end-expiration breath sample 40 is captured in collection chamber 14. To retrieve the end-expiration breath sample 40 for convenient sampling by gas chromatography equipment, it is desirable to collect end-expiration breath sample 40 in an evacuated air chamber 100 (a test tube). Evacuated air chamber 100 is of a volume V1, which is preferably a smaller volume than volume V2 of the collection chamber 14, so that evacuated air chamber 100 collects only end-expiration breath sample 40 from the collection chamber 14, and not outside air drawn through collection chamber 14.

    [0020] Evacuated air chamber 100 is inserted into a distal end of the discharge chute 16 as shown in Fig. 4, and as shown in Fig. 5, evacuated air chamber 100 is inserted onto discharge needle 22, piercing a septum 20 (preferably self-sealing) of air chamber 100. The evacuated air chamber 100 then retrieves end-expiration breath sample 40 from collection chamber 14. After air chamber 100 has retrieved end-expiration breath sample 40 from collection chamber 14, the air chamber 100 can be withdrawn from the discharge needle 22 within discharge chute 16. The air chamber 100 containing end-expiration breath sample 40 can then be processed in a laboratory for target analytes as desired.

    [0021] The foregoing is considered as illustrative only of the principles of the invention. Furthermore, since numerous modifications and changes will readily occur to those skilled in the art, it is not desired to limit the invention to the exact construction and operation shown and described. While the preferred embodiment has been described, the details may be changed without departing from the scope of the invention which is defined in the claims.


    Claims

    1. A breath collection apparatus (10) comprising:

    a breath entryway (12);

    a first one-way coupling (24, 26);

    a collection chamber (14) having proximal and distal ends and coupled at its proximal end to said breath entryway by said first one-way coupling;

    a second one-way coupling (24, 26) coupled to the distal end of said collection chamber;

    a sample transfer assembly (22) coupled to the distal end of said collection chamber that can be selectively coupled to an evacuated air chamber (100) to collect a portion of an end-expiration breath sample contained within the collection chamber, said sample transfer assembly (22) comprising a needle for penetrating a septum sealing the evacuated air-chamber; and

    a discharge chute (16) coupled to the distal end of said collection chamber (14) about said sample transfer assembly (22), said discharge chute comprising a proximal end for coupling to said collection chamber, and a distal end for receiving said evacuated air chamber (100),
    wherein the breath entryway, the first one-way coupling, the collection chamber, the second one-way coupling, the sample transfer assembly and the discharge chute are aligned with one another.
     
    2. A breath collection apparatus according to claim 1, the apparatus further comprising an evacuated air chamber (100) selectively coupled to said sample transfer assembly (22).
     
    3. A breath collection apparatus according to claim 1 or 2, at least one of said one-way couplings (24, 26) comprising a flutter valve.
     
    4. A breath collection apparatus according to claim 1 or 2, wherein the first one-way coupling (24, 26) comprises a flexible ring (24) that overlies one or more apertures provided in a downstream portion of the mouthpiece, said flexible ring being caused to flex away from the apertures by the pressure of a patient blowing into the mouthpiece (12) to allow air to pass from the mouthpiece into the collection chamber (14).
     
    5. A breath collection apparatus according to claim 1, wherein the second one-way coupling (24, 26) comprises a flexible ring (24) that overlies one or more apertures provided in a downstream portion of the collection chamber (14), said flexible ring being caused to flex away from the apertures by the pressure of a patient blowing into the mouthpiece (12) to allow air to pass from the collection chamber (14) into the discharge chute (16).
     
    6. A breath collection apparatus according to claim 5, wherein the first one-way coupling (24, 26) comprises a flexible ring (24) that overlies one or more apertures provided in a downstream portion of the mouthpiece, said flexible ring being caused to flex away from the apertures by the pressure of a patient blowing into the mouthpiece (12) to allow air to pass from the mouthpiece into the collection chamber (14).
     
    7. A breath collection apparatus according to claim 5 or 6, wherein the flexible rings (24) of the first and second one-way couplings (24, 26) return to a static position flush against the one or more apertures provided in the mouthpiece (12) and the collection chamber (14) when the patient stops exhaling into the mouthpiece to seal air in the collection chamber for collection in an evacuated air chamber (100).
     
    8. A breath collection apparatus according to claim 7, the apparatus further comprising an evacuated air chamber (100) selectively coupled to said sample transfer assembly (22).
     


    Ansprüche

    1. Atemgassammelvorrichtung (10), umfassend:

    einen Atemgaszugang (12);

    eine erste Einwegkupplung (24, 26);

    eine Sammelkammer (14) mit einem proximalen und einem distalen Ende, die an ihrem proximalen Ende durch die erste Einwegkupplung mit dem Atemgaszugang gekoppelt ist;

    eine zweite Einwegkupplung (24, 26), die mit dem distalen Ende der Sammelkammer gekoppelt ist;

    eine unbewegliche Probenübertragungsanordnung (22), die an das distale Ende der Sammelkammer gekoppelt ist, die selektiv an einer entleerten Luftkammer (100) angekoppelt werden kann, um einen Teil einer Atemgasprobe am Ende des Ausatmens, die in der Sammelkammer enthalten ist, zu sammeln, wobei die Probenübertragungsanordnung (22) eine Nadel zum Durchdringen eines die entleerte Luftkammer abdichtenden Septums umfasst; und

    eine Entleerungsrinne (16), die mit dem distalen Ende der Sammelkammer (14) über die Probenübertragungsanordnung (22) gekoppelt ist, wobei die Entleerungsrinne ein proximales Ende zum Koppeln mit der Sammelkammer und ein distales Ende zum Aufnehmen der entleerten Luftkammer (100) umfasst,
    wobei der Atemgaszugang, die erste Einwegkupplung, die Sammelkammer, die zweite Einwegkupplung, die Probenübertragungsanordnung und die Entleerungsrinne zueinander ausgerichtet sind.
     
    2. Atemgassammelvorrichtung nach Anspruch 1, wobei die Vorrichtung ferner eine entleerte Luftkammer (100) umfasst, die selektiv mit der Probenübertragungsanordnung (22) gekoppelt ist.
     
    3. Atemgassammelvorrichtung nach Anspruch 1 oder 2, wobei mindestens eine der Einwegkupplungen (24, 26) ein Flatterventil umfasst.
     
    4. Atemgassammelvorrichtung nach Anspruch 1 oder 2, wobei die erste Einwegkupplung (24, 26) einen flexiblen Ring (24) umfasst, der über einer oder mehreren Öffnungen liegt, die in einem stromabwärtigen Abschnitt des Mundstücks vorgesehen sind, wobei der flexible Ring sich durch den Druck des Blasens eines Patienten in das Mundstück (12) von den Öffnungen wegbiegt, um zu ermöglichen, dass die Luft aus dem Mundstück in die Sammelkammer (14) gelangen kann.
     
    5. Atemgassammelvorrichtung nach Anspruch 1, wobei die zweite Einwegkupplung (24, 26) einen flexiblen Ring (24) umfasst, der über einer oder mehreren Öffnungen liegt, die in einem stromabwärtigen Abschnitt der Sammelkammer (14) vorgesehen sind, wobei der flexible Ring sich durch den Druck des Blasens eines Patienten in das Mundstück (12) von den Öffnungen wegbiegt, um zu ermöglichen, dass die Luft aus der Sammelkammer (14) in die Entleerungsrinne (16) gelangen kann.
     
    6. Atemgassammelvorrichtung nach Anspruch 5, wobei die erste Einwegkupplung (24, 26) einen flexiblen Ring (24) umfasst, der über einer oder mehreren Öffnungen liegt, die in einem stromabwärtigen Abschnitt des Mundstücks vorgesehen sind, wobei der flexible Ring sich durch den Druck des Blasens eines Patienten in das Mundstück (12) von den Öffnungen wegbiegt, um zu ermöglichen, dass die Luft aus dem Mundstück in die Sammelkammer (14) gelangen kann.
     
    7. Atemgassammelvorrichtung nach Anspruch 5 oder 6, wobei die flexiblen Ringe (24) der ersten und der zweiten Einwegkupplung (24, 26) in eine statische Position zurückkehren, die bündig an der einen oder den mehreren Öffnung(en) in dem Mundstück (12) und in der Sammelkammer (14) liegt, wenn der Patient nicht mehr in das Mundstück ausatmet, um die Luft in der Sammelkammer zum Sammeln in einer entleerten Luftkammer (100) abzudichten.
     
    8. Atemgassammelvorrichtung nach Anspruch 7, wobei die Vorrichtung ferner eine entleerte Luftkammer (100) umfasst, die selektiv mit der Probenübertragungsanordnung (22) gekoppelt ist.
     


    Revendications

    1. Appareil de recueil d'air expiré (10), comprenant :

    une entrée d'air expiré (12) ;

    un premier couplage unidirectionnel (24, 26) ;

    une chambre de recueil (14) ayant des extrémités proximale et distale et couplée au niveau de son extrémité proximale à ladite entrée d'air expiré au moyen dudit premier couplage unidirectionnel ;

    un second couplage unidirectionnel (24, 26) couplé à l'extrémité distale de ladite chambre de recueil ;

    un dispositif de transfert d'échantillon fixe (22) couplé à l'extrémité distale de ladite chambre de recueil, qui peut être couplée sélectivement à une chambre à air sous vide (100) pour recueillir une partie d'un échantillon d'air expiré d'expiration finale contenu à l'intérieur de la chambre de recueil, ledit dispositif de transfert d'échantillon (22) comprenant une aiguille destinée à pénétrer dans un septum scellant la chambre à air sous vide ; et

    une goulotte d'évacuation (16) couplée à l'extrémité distale de ladite chambre de recueil (14) autour dudit dispositif de transfert d'échantillon (22), ladite goulotte d'évacuation comprenant une extrémité proximale destinée à être couplée à ladite chambre de recueil, et une extrémité distale destinée à recevoir ladite chambre à air sous vide (100),
    l'entrée d'air expiré, le premier couplage unidirectionnel, la chambre de recueil, le second couplage unidirectionnel, le dispositif de transfert d'échantillon et la goulotte d'évacuation étant alignés les uns avec les autres.
     
    2. Appareil de recueil d'air expiré selon la revendication 1, l'appareil comprenant en outre une chambre à air sous vide (100) couplée sélectivement audit dispositif de transfert d'échantillon (22).
     
    3. Appareil de recueil d'air expiré selon la revendication 1 ou 2, au moins l'un desdits couplages unidirectionnels (24, 26) comprenant une soupape flottante.
     
    4. Appareil de recueil d'air expiré selon la revendication 1 ou 2, dans lequel le premier couplage unidirectionnel (24, 26) comprend une bague flexible (24) qui recouvre une ou plusieurs ouvertures prévues dans une partie aval de l'embout buccal, ladite bague flexible étant amenée à fléchir en s'éloignant des ouvertures sous l'effet de la pression d'un patient soufflant dans l'embout buccal (12) pour permettre à l'air de passer de l'embout buccal à la chambre de recueil (14).
     
    5. Appareil de recueil d'air expiré selon la revendication 1, dans lequel le second couplage unidirectionnel (24, 26) comprend une bague flexible (24) qui recouvre une ou plusieurs ouvertures prévues dans une partie aval de la chambre de recueil (14), ladite bague flexible étant amenée à fléchir en s'éloignant des ouvertures sous l'effet de la pression d'un patient soufflant dans l'embout buccal (12) pour permettre à l'air de passer de la chambre de recueil (14) vers la goulotte d'évacuation (16).
     
    6. Appareil de recueil d'air expiré selon la revendication 5, dans lequel le premier couplage unidirectionnel (24, 26) comprend une bague flexible (24) qui recouvre une ou plusieurs ouvertures prévues dans une partie aval de l'embout buccal, ladite bague flexible étant amenée à fléchir en s'éloignant des ouvertures sous l'effet de la pression d'un patient soufflant dans l'embout buccal (12) pour permettre à l'air de passer de l'embout buccal à la chambre de recueil (14).
     
    7. Appareil de recueil d'air expiré selon la revendication 5 ou 6, dans lequel les bagues flexibles (24) des premier et second couplages unidirectionnels (24, 26) reviennent dans une position statique affleurant contre une ou plusieurs ouvertures prévues dans l'embout buccal (12) et la chambre de recueil (14) lorsque le patient cesse d'expirer dans l'embout buccal, de façon à sceller l'air dans la chambre de recueil pour qu'il soit recueilli dans une chambre à air sous vide (100).
     
    8. Appareil de recueil d'air expiré selon la revendication 7, l'appareil comprenant en outre une chambre à air sous vide (100) couplée sélectivement audit dispositif de transfert d'échantillon (22).
     




    Drawing











    Cited references

    REFERENCES CITED IN THE DESCRIPTION



    This list of references cited by the applicant is for the reader's convenience only. It does not form part of the European patent document. Even though great care has been taken in compiling the references, errors or omissions cannot be excluded and the EPO disclaims all liability in this regard.

    Patent documents cited in the description




    Non-patent literature cited in the description