Breath Testing Device

Abstract

A breath testing device for testing for hydrogen sulfide and other parameters in a patient's breath is provided, comprising an ambient air input for receiving ambient air and a patient sample input for receiving breath from the patient, a valve coupled to the patient sample input and the ambient air input, and a first path and a second path from the valve to a hydrogen sulfide sensor block and a second sensor block.

Description

[Technical field]

[0001] The present invention relates to the field of sampling air from the lungs, and in particular to the field of obtaining samples of a person's air, including alveolar air from the alveoli of the person's lungs. [Background technology]

[0002] Air from a person's lungs can be used for many different types of tests that would normally require the person to undergo an invasive procedure. For example, alveolar air can be analyzed for the non-invasive diagnosis of a wide variety of conditions, including but not limited to, the non-invasive diagnosis of ulcers, enzyme deficiencies, and gastric infections that are associated with a high incidence of metabolic diseases and / or disorders. Critical to any such test is the ability to obtain an accurate sample that contains a sufficient amount of air representative of the true alveolar air required for the particular test.

[0003] Since hydrogen and methane are produced in the digestive system primarily by bacterial fermentation of carbohydrates (sugars, starches, or plant fibers), the appearance of any of these gases in the breath usually indicates that carbohydrates or carbohydrate fragments have been exposed to bacteria and allowed such fermentation to occur. Levitt, MD, "Production and excretion of hydrogen gas in man," New Engl. J. Med 1968;281:122 (incorporated herein by reference). The production of H2 and / or CH4 results in the reabsorption of some of these gases from their digestive sites into the bloodstream, where they appear in the breath.

[0004] Bacteria are not abundant in the small intestine, where sugar digestion and absorption normally occurs, so when a challenge dose (e.g., lactose) is ingested, the level of hydrogen in the alveolar air increases significantly within 1-2 hours (depending on intestinal transit time) only if the sugar is not digested and therefore reaches the colon.

[0005] Breath H2 testing is a simple, non-invasive procedure that is readily accepted by patients and staff (Metz, G., Jenkins, DL, Peters, TJ, Newman, A., Blendis, LM, et al., "Breath hydrogen as a diagnostic method for hypolactasia," Lancet. 1975;1(7917):1155-7, incorporated herein by reference), and has been widely reported to be more reliable and acceptable than blood tests (DiPalma, JA, Narvaez, RM, et al., "Prediction of lactose malabsorption in referral patients," Dig Dis Sci. 1988;33:303, incorporated herein by reference, and Davidson, GP, Robb, TA, et al., "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, CE, Douwes, A, C, Slotema, E., Degenhart, HJ, et al. “Respiratory hydrogen excretion as a parameter for lactose malabsorption in children” Amer J Clin Nutr.1978;31:597-602, Newcomer, AD, McGill, DB, Thomas, RJ, Hofmann, AF, et al. "Prospective comparison of indirect methods for detecting lactase deficiency" New Engl J Med.1975;293:1232-6, Douwes, AC, Fernandes, J., Degenhart HJ(E. et al., "Improved accuracy of lactose tolerance test in children, using expired H2 measurement," Arch Dis Child. 1978;53:939-42; Solomons, NW, Garcia-Ibanez, R., Viteri, FE, et al., "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, each of which is incorporated by reference).

[0006] Low doses of lactose usually do not cause the discomfort and explosive diarrhea frequently seen in malabsorbers who are given the high doses required for blood testing.

[0007] A study of over 300 patients showed that GI symptoms after a lactose load were strongly related to the amount of H2 excreted, with the relationship between changes in blood glucose and symptom severity being less clear.Jones, DV, Latham, MC, Kosikowski, FV, Woodward, G., et al., "Symptom response to lactosereduced milk in lactose-intolerant adults," Amer J Clin Nutr. 1976;29(6):633-8, incorporated by reference.

[0008] False positive breath test results are rare, and when they do occur, they are usually caused by performing the test improperly, i.e., allowing the subject to smoke, sleep or eat just before or during the test.11 Bacterial overgrowth (retrograde from the colon to the small intestine) can also result in a false positive breath test result, but it is usually preceded by an elevation in fasting breath H2 levels, and the response is seen shortly (within 20-30 minutes) after sugar is ingested.

[0009] The incidence of false-negative results with breath tests is much lower than that seen with blood tests. False-negative results are reported to result from 5-15% of all individuals with lactose malabsorption. Filali, A., Ben Hassine, L., Dhouib, H., Matri, S., Ben Ammar, A., Garoui, H. et al., “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, AC, Schaap, C., van der. Kleivan Moorsel, JM et al., “Hydrogen breath test in school children” Arch Dis Child.1985;60:333-7, Rogerro, P., Offredi, ML., Mosca, F., Perazzani, M., Mangiaterra, V., Ghislanzoni, P., Marenghi, L., Careddu, P. et al., “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, each of which is incorporated by reference. This is due to a variety of causes. Measuring methane in addition to hydrogen can avoid many of the false negative reports, as some methanogenic flora convert colonic H2 to CH4.Cloarac, D., Bornet, F., Gouilloud, S., Barry, J. Ll., Salim, B., Galmiche, J. P., et al., "Breath hydrogen response to lactulose in healthy subjects: relationship to methane producing status", Gut. 1990 (Mar); 31: 300-4, incorporated by reference.

Prior Art Documents

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Summary of the Invention

[0011] According to the present invention, there is provided a testing device: A breath collection device is used to collect a breath sample from a patient.

[0012] The patient breath sample is transported by a sample pump through the patient dryer unit to the humidity sensor and the flow sensor. At the first valve, a portion of the sample is vented to the atmosphere and the remainder of the sample is transported at the patient sample input to the second valve. At the second valve, the atmospheric input is also introduced. The atmospheric input receives air from the atmosphere by a pump that delivers the atmospheric input through the room dryer unit, the humidity sensor, the variable air flow valve, the flow sensor, and finally the atmospheric air valve, which supplies the atmospheric air to the second valve and vents the excess back to the atmosphere.

[0013] From the second valve, the patient sample / atmospheric air combination proceeds to a t-valve that splits the patient sample / atmospheric air combination into two paths. The first path leads to a hydrogen sulfide block and the second path leads to a second sensor block.

[0014] The system is preferably coupled to the computer / display unit at a selected location, for example via connections between the computer / display unit and the sample pump, humidity sensor, flow sensor, valves, hydrogen sulfide sensor block and second sensor block. [Brief description of the drawings]

[0015] [Figure 1] FIG. 1 is a perspective view of the sample collection device with an evacuated air chamber inserted into the tip of the discharge chute. [Diagram 2] FIG. 2 is an exploded perspective view of the sample collection device. [Diagram 3] FIG. 2 is a cross-sectional side view of the sample collection device in use, showing the collection of a breath sample; [Figure 4] FIG. 2 is a side cross-sectional view of the sample collector with an evacuated air chamber inserted into the tip of the discharge chute. [Diagram 5] FIG. 1 is a side cross-sectional view of a sample collection device with an evacuated air chamber inserted over an ejection needle in the ejection chute. [Figure 6] FIG. 1 shows end-tidal breath samples taken. [Figure 7] FIG. 1 is a schematic diagram of an air sample unit of the present invention. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0016] Although the disclosure herein is detailed and accurate to enable one skilled in the art to practice the invention, the physical embodiments disclosed herein are merely illustrative of the invention which may be embodied in other specific structures. Although preferred embodiments are described, the details may be changed without departing from the invention.

[0017] 1, there is shown a perspective view of a sample collection device 10 of the present invention. Shown is a mouthpiece 12 with an exhalation inlet to allow exhaled breath to pass to a collection chamber 14. An exhalation exhaust chute 16 receives an evacuated air chamber 100 which receives an end-tidal breath sample (described below) from within the collection chamber 14.

[0018] 2, an exploded perspective view of the sample collection device 10 of the present invention is shown. The mouthpiece 12 is integrally formed with or coupled to a one-way exhaust assembly 26. Positive pressure from exhaled air through the mouthpiece 12 causes a flexible ring 24 to flex and pass air into the collection chamber 14 at the upstream end of the collection chamber 14. The flexible ring 24 is preferably, but not necessarily, a flutter valve. Coupled to the downstream end of the collection chamber 14 is another one-way exhaust structure 24, also coupled to the flexible ring 24 (also preferably, but not necessarily, a flutter valve). Coupled to the interior of the collection chamber 14 is an exhaust needle 22 which provides a selective passageway from the exhaled air between the collection chamber 14 and the ultimately evacuated air chamber 100 which is coupled to the exhaust needle 22 via the exhaust chute 16.

[0019] 3, a side cross-sectional view of the sample collection device 10 in use is shown. The patient presses his mouth against the mouthpiece 12 and begins to exhale. A first exhaled volume 42 exhausts background air from within the collection chamber 14 and is exhaled through the exhaust chute 16 without being trapped, as the first exhaled volume 42 is least desirable for alveolar air sampling. Positive pressure from the exhaled breath sample flexes the flexible ring 24, allowing air to continue to flow through the collection chamber 14 and into the exhaust chute 16.

[0020] When exhalation stops, the positive pressure from the breath also stops, allowing the flexible rings 24 to return to their resting positions and become flush with the one-way exhaust structure 26 at the upstream and downstream ends of the collection chamber 14. When the flexible rings 24 seal the collection chamber 14, the end-tidal breath sample 40 is captured within the collection chamber 14. To collect the end-tidal breath sample 40 for convenient sampling by a gas chromatography device, it is desirable to collect the end-tidal breath sample 40 in an evacuated air chamber 100 (test tube). The evacuated air chamber 100 has a volume V1 that is preferably smaller in volume than the volume V2 of the collection chamber 14, such that the evacuated air chamber 100 only collects the end-tidal breath sample 40 from the collection chamber 14 and not the outside air drawn through the collection chamber 14.

[0021] An evacuated air chamber 100 is inserted into the tip of the discharge chute 16 as shown in FIG. 4, and the evacuated air chamber 100 is inserted over the discharge needle 22, penetrating the septum 20 (preferably self-sealing) of the air chamber 100 as shown in FIG. 5. The evacuated air chamber 100 then collects the end-tidal breath sample 40 from the collection chamber 14. Once the air chamber 100 has collected the end-tidal breath sample 40 from the collection chamber 14, the air chamber 100 can be withdrawn from the discharge needle 22 in the discharge chute 16. As shown in FIG. 6, the air chamber 100 containing the end-tidal breath sample 40 can be processed in a laboratory for targeted analysis as desired.

[0022] In a preferred embodiment, referring now to Figure 7, a schematic diagram of an air sample unit 200 of the present invention is shown. An air chamber 100 containing an end-tidal breath sample 40 can be connected to location 210 where the patient breath sample 210 is transported through a patient dryer unit 220 by a sample pump 230, a humidity sensor 240, and a flow sensor 250. An alternative dryer such as Nafion™ tubing can be used in place of the conventional dryer unit 220. At a first valve 260, a portion of the sample 210 is vented to the atmosphere and the remainder of the sample is transported to a second valve 270 at the patient sample input C / A.

[0023] The second valve 270 also introduces an input of ambient air. In a preferred embodiment, the sensors 320 and 360 receive constant dehumidified air to them for testing and operational stability when the sample air is not being tested. The sensor block 360 preferably includes at least one of a hydrogen sensor, a methane sensor, and a carbon dioxide sensor. In this preferred embodiment, when a patient sample is introduced to the input 210, the air in the room dryer unit 420 is shut off and the patient sample is introduced to the input 210. The ambient air input of 270 receives air from the atmosphere through the room dryer unit 420, the humidity sensor 410, the pump 400, the variable air flow valve 390, the flow sensor 380, and finally the ambient air valve 370, which supplies ambient air to the second valve 270 and vents the excess back to the atmosphere.

[0024] From the second valve 270, the patient sample 210 / atmospheric air combination proceeds to a t-valve 280 which splits the patient sample 210 / atmospheric air combination into two paths. The first path proceeds from the valve 280 through a third valve 290 which is further vented to the atmosphere and also to a hydrogen sulfide storage coil 300. The valve 290 (optional) is preferably a pressure valve to provide an appropriate amount of sample to the H2S storage coil 300. Similarly, following the hydrogen sulfide coil 300 (optional), the patient sample 210 / atmospheric air combination proceeds to a fourth valve 310 (optional pressure valve to provide an appropriate amount of sample to the H2S storage coil 300) which splits the patient sample 210 / atmospheric air and sends the excess to the atmosphere and the remainder to the hydrogen sensor block 320 to be tested for hydrogen sulfide.

[0025] From valve 280, the patient sample 210 / atmospheric air combination is also transmitted through valve 330 and further vented to the atmosphere and to a storage coil 340. In another embodiment, unit 340 can be a molecular sieve column. Following the storage coil 340, the patient sample 210 / atmospheric air is sent to a sixth valve 350 which splits the patient sample 210 / atmospheric air combination and sends the excess to the atmosphere and the remainder to a sensor block 360 and vented to the atmosphere.

[0026] The sensor blocks 320 and 360 provide signals to a computer / display device such as that disclosed in U.S. Patent No. 9,140,685, which is incorporated herein by reference. The system is preferably coupled to the computer / display unit at selected locations for monitoring and management, for example, via connections between the computer / display unit and the sample pumps 230, 400, humidity sensors 240 / 410, flow sensors 250 / 380, valves 260, 270, 310, 330, 370, hydrogen sulfide sensor block 320 and second sensor block 360.

[0027] The foregoing is considered as merely illustrative of the principles of the invention. Moreover, 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 as shown and described. Although preferred embodiments have been described above, changes may be made in detail without departing from the invention.

Claims

1. A breath testing device, comprising: a patient sample input for receiving breath from a patient; an atmospheric input for receiving atmospheric air; a valve coupled to the patient sample input and to the atmosphere input; A hydrogen sulfide sensor block; A second sensor block; a first path from the valve to the hydrogen sulfide sensor block; a second path from the valve to the second sensor block; a first pump between the patient sample input and the valve; and a second pump between the atmosphere input and the valve.

13. A breath testing device comprising:

2. 10. The breath testing device of claim 1, further comprising a computer coupled to the hydrogen sulfide sensor block and the second sensor block.

3. 2. The breath testing device of claim 1, further comprising a first dryer unit between the first pump and the patient sample input, and a second dryer unit between the ambient air input and the second pump.

4. A breath testing device, comprising: a patient sample input for receiving breath from a patient; an atmospheric input for receiving atmospheric air; a valve coupled to the patient sample input and to the atmosphere input; A hydrogen sulfide sensor block; A second sensor block; a first path from the valve to the hydrogen sulfide sensor block; a second path from the valve to the second sensor block; The breath testing device further comprising a first humidity sensor between the patient sample input and the valve, and a second humidity sensor between the ambient air input and the valve.

5. A breath testing device, comprising: a patient sample input for receiving breath from a patient; an atmospheric input for receiving atmospheric air; a valve coupled to the patient sample input and to the atmosphere input; A hydrogen sulfide sensor block; A second sensor block; a first path from the valve to the hydrogen sulfide sensor block; a second path from the valve to the second sensor block; The breath testing device further includes a variable air flow valve and a flow sensor between the air inlet and the valve.

6. A breath testing device, comprising: a patient sample input for receiving breath from a patient; an atmospheric input for receiving atmospheric air; a valve coupled to the patient sample input and to the atmosphere input; A hydrogen sulfide sensor block; A second sensor block; a first path from the valve to the hydrogen sulfide sensor block; a second path from the valve to the second sensor block; The breath testing device further comprises a first relief valve venting to atmosphere between the patient sample input and the valve, and a second relief valve venting to atmosphere between the atmosphere input and the valve.

7. 2. The breath testing device of claim 1, wherein the first path includes a t-valve and a hydrogen sulfide storage coil.

8. 2. The breath testing device of claim 1, wherein the second path includes at least one of a storage coil or a molecular sieve separation column.

9. 2. The breath testing device of claim 1, wherein the second sensor block includes at least one of a hydrogen sensor, a methane sensor, and a carbon dioxide sensor.

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