Breath test device

Abstract

An expiratory test device is provided to test for hydrogen sulfide and other parameters in exhaled breath from a patient. In addition to an atmospheric input for receiving atmospheric air, a patient sample input is provided for receiving exhaled breath from a patient. A valve is coupled to the patient sample input and the atmospheric input, and first and second pathways are provided from the valve to a hydrogen sulfide sensor module and a second sensor module.

Description

Background Technology

[0001] This invention relates to the field of sampling air from the lungs, and more particularly to the field of obtaining samples of an individual's air (including alveolar air from the alveoli of the individual's lungs).

[0002] Air from a person's lungs can be used for many different types of tests that would otherwise require invasive surgery. For example, alveolar air can be analyzed for, but not limited to, non-invasive diagnostics of a wide variety of conditions, including gastric infections and / or abnormalities associated with a high incidence of ulcers, enzyme deficiencies, and metabolic conditions. For any such test, the key is the ability to obtain an accurate sample containing a sufficient volume of air to represent true alveolar air, which is necessary for the specific test.

[0003] Hydrogen and methane are produced in the digestive system by bacteria that ferment primarily carbohydrates (sugars, starches, or plant fibers). Therefore, the presence of either of these gases in exhaled air is generally a signal that carbohydrates or carbohydrate fragments have been exposed to bacteria, allowing this fermentation to proceed. (Levitt, MD, Production and excretion of hydrogen gas in man, New Engl. J. Med 1968; 281:122). The production of H2 and / or CH4 will cause some of these gases to be reabsorbed into the bloodstream from the site of digestion, and they will appear in exhaled air.

[0004] Bacteria are not typically found in large quantities in the small intestine, where the digestion and absorption of carbohydrates take place. Therefore, when a challenge dose (such as lactose) is ingested, the level of hydrogen in the alveolar air will only rise significantly within one to two hours (depending on intestinal transit time) if the sugar is not digested and thus reaches the colon.

[0005] The breath-H2 test is a simple, non-invasive procedure that is readily accepted by patients and staff (Metz, G.; Jenkins, DL; Peters, TJ; Newman, A.; Blendis, LMBreath hydrogen as a diagnostic method for hypolactasia, Lancet. 1975; 1(7917):1155-7, incorporated herein by reference), and it is more reliable and acceptable than blood tests, according to most reports in the literature (DiPalma, JA; Narvaez, RMPrediction of lactose malabsorption in referral patients, Dig Dis Sci. 1988; 33:303, incorporated herein by reference; and Davidson, GP; Robb, TA. Value of breath hydrogen analysis in management of diarrheal illness in childhood: Comparison with duodenal Biopsy (The value of exhaled hydrogen analysis in the management of diarrheal diseases in children: a comparison with duodenal biopsy), J Ped Gastroenterol Nutr. 1985; 4:381-7; Fernandes, J.; Vos, CE; Douwes, A, C; Slotema, E.; Degenhart, HJ. 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. Prospective comparison of indirect methods for detecting lactase deficiency, New Engl J Med. 1975; 293:1232-6; Douwes, AC; Fernandes, J.Degenhart HJ, Improved accuracy of lactose tolerance test in children, using exhaled H2 measurement, Arch Dis Child, 1978; 53:939-42; Solomons, NW; Garcia-Ibanez, R.; Viteri, FE, 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 article is incorporated herein by reference).

[0006] Lower doses of lactose typically do not cause discomfort and explosive diarrhea, symptoms that are common in malabsorbent individuals who are given the large doses of lactose required for blood tests.

[0007] A study of over 300 patients showed that GI symptoms following a lactose challenge were closely associated with H2 excretion, while the relationship between blood glucose changes and symptom severity was less pronounced. Jones, DV; Latham, MC; Kosikowski, FV; Woodward, G. Symptom response to lactose-reduced milk in lactose-intolerant adults, Amer J Clin Nutr. 1976, 29(6):633-8, is incorporated herein by reference.

[0008] False positive breath tests are very rare, and when they do occur, they are usually due to testing errors—allowing the subject to smoke, sleep, or eat shortly before or during the test. Bacterial overgrowth (retrograde from the colon into the small intestine) can also produce false positive breath tests, but it is usually preceded by elevated fasting breath-H2 levels and a response is seen shortly after sugar intake (within 20-30 minutes).

[0009] The incidence of false negative results in breath tests is far lower than that seen in blood tests. False negative results are reportedly found in 5-15% of all lactose malabsorption individuals. 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 ClinBiol. 1987; 11:554-7; Douwes, AC; Schaap, C.; van der Kleivan Moorsel, J. H. 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. Lactose absorption and Malabsorption in healthy Italian children: Do the quantity of malabsorbed sugar and the smallbowel transit time play roles in symptom production? (J Pediatr Gastroenterol Nutr. 1985 (Feb); 4(1):82-614; each of which is incorporated herein by reference.) This is due to a variety of reasons. Many false negative reports can be avoided by measuring methane as well as hydrogen, because some methanogenic bacteria convert colonic H2 to CH4.Cloarac, D.; Bornet, F.; Gouilloud, S.; Barry, J.L.; Salim, B.; Galmiche, J.P. Breath, Gut. 1990 (Mar); 31:300-4; incorporated herein by reference. Summary of the Invention

[0010] According to the present invention, a testing device is provided. A breath collection device is used to collect breath samples from a patient.

[0011] Patient breath samples are delivered by a sample pump through a patient drying unit to a humidity sensor and a flow sensor. At a first valve, a portion of the sample is released into the atmosphere, and the remainder is delivered to a second valve at the patient sample input. An atmospheric input is also introduced at the second valve. This atmospheric input receives air from the atmosphere via a pump that sequentially passes through the space drying unit, humidity sensor, variable flow valve, flow sensor, and finally an atmospheric air valve that supplies atmospheric air to the second valve and releases excess air back into the atmosphere.

[0012] The patient sample / atmospheric air combination passes from the second valve through a three-way valve, which splits the patient sample / atmospheric air combination into two paths. The first path leads to the hydrogen sulfide module (block), and the second path leads to the second sensor module.

[0013] The system is connected at a selected location to the computer / display unit via a connection, preferably between, for example, the computer / display unit and the following: a sample pump, a humidity sensor, a flow sensor, a valve, a hydrogen sulfide sensor module, and a second sensor module. Attached Figure Description

[0014] Figure 1 It is a perspective view of the sample collection device, and the emptied air chamber is inserted into the distal end of the discharge channel;

[0015] Figure 2 This is an exploded perspective view of the sample collection device;

[0016] Figure 3 This is a side cross-sectional view of the sample collection device in use, showing the collection of exhaled samples;

[0017] Figure 4 It is a side sectional view of the sample collection device, in which the emptied air chamber is inserted into the distal end of the discharge channel;

[0018] Figure 5 It is a side sectional view of the sample collection device, in which the emptied air chamber is inserted into the discharge needle in the discharge channel;

[0019] Figure 6 The image shows the collection of terminal exhaled breath samples; and

[0020] Figure 7 This is a schematic diagram of the air sample unit of the present invention. Detailed Implementation

[0021] While the disclosure herein is detailed and precise to enable those skilled in the art to practice the invention, the physical embodiments disclosed herein are merely illustrative examples of the invention, which may be implemented in other specific configurations. Although preferred embodiments have been described, details may be changed without departing from the invention.

[0022] Now refer to Figure 1 A perspective view of the sample collection device 10 of the present invention is shown. A mouthpiece 12 including an exhalation inlet passage is shown to allow exhaled air to pass into the collection chamber 14. An exhalation outlet passage 16 receives an emptied air chamber 100 that receives terminal exhaled breath samples (described later) from within the collection chamber 14.

[0023] Now refer to Figure 2 An exploded perspective view of the sample collection device 10 of the present invention is shown. A mouthpiece 12 is integrally formed with or connected to a one-way discharge assembly 26. Positive pressure from exhalation causes deformation of a deformable ring 24 through the mouthpiece 12, allowing air to pass from the upstream end of the collection chamber 14 into the collection chamber 14. The deformable ring 24 is preferably, but not necessarily, a flutter valve. Another one-way discharge structure 24, also connected to the deformable ring 24 (and again preferably, but not necessarily, a flutter valve), is connected to the downstream end of the collection chamber 14. A discharge needle 22 is connected to the interior of the collection chamber 14 and provides selective passage for exhalation between the collection chamber 14 and a finally emptied air chamber 100, which is connected to the discharge needle 22 via a discharge channel 16.

[0024] Now refer to Figure 3The image shows a side sectional view of the sample collection device 10 in use. The patient presses their mouth against the mouthpiece 12 and begins to exhale. A first volume 42 of exhaled air empties the background air from the collection chamber 14, and this first volume 42 of exhaled air (which is not ideal for alveolar air sampling) is expelled uncaptured through the discharge channel 16. The positive pressure from the exhaled breath sample deforms the deformable ring 24 to allow air to continue flowing through the collection chamber 14 into the discharge channel 16.

[0025] When exhalation ceases, the positive pressure from the exhalation also ceases, allowing the deformable rings 24 to return to their static position and align with the unidirectional discharge structures 26 at the upstream and downstream ends of the collection chamber 14. When the deformable rings 24 seal the collection chamber 14, the terminal exhaled breath sample 40 is captured within the collection chamber 14. Ideally, the terminal exhaled breath sample 40 should be collected in an emptied air chamber 100 (test tube) for sampling by gas chromatography equipment. The emptied air chamber 100 has a volume V1, which is preferably smaller than the volume V2 of the collection chamber 14, such that the emptied air chamber 100 collects only the terminal exhaled breath sample 40 from the collection chamber 14, and not external air inhaled through the collection chamber 14.

[0026] like Figure 4 As shown, the emptied air cavity 100 is inserted into the distal end of the discharge channel 16, and as... Figure 5 As shown, the emptied air chamber 100 is inserted into the discharge needle 22, which pierces the septum 20 (preferably self-sealing) of the air chamber 100. The emptied air chamber 100 then retrieves a terminal exhaled breath sample 40 from the collection chamber 14. After the air chamber 100 retrieves the terminal exhaled breath sample 40 from the collection chamber 14, the air chamber 100 can be withdrawn from the discharge needle 22 within the discharge channel 16. Figure 6 As shown, the air chamber 100 containing the terminal exhaled breath sample 40 can then be processed in the laboratory as needed for the target analyte.

[0027] Now refer to Figure 7 In a preferred embodiment, a schematic diagram of the air sample unit 200 of the present invention is shown. An air chamber 100 containing a terminal exhaled breath sample 40 can be connected to a location 210, where the patient's exhaled breath sample 210 is delivered via a patient drying unit 220, a sample pump 230, a humidity sensor 240, and a flow sensor 250. Alternative dryers, such as Nafion, can be used. TM A tube is used instead of the conventional drying unit 220. At the first valve 260, a portion of the sample 210 is discharged into the atmosphere, and the remainder of the sample is conveyed to the second valve 270 at the patient sample input terminal C / A.

[0028] An atmospheric input is also introduced at the second valve 270. In a preferred embodiment, if no sample air test is performed, sensors 320 and 360 receive a constant supply of dehumidified air for testing and operational stability. Sensor module 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 into input 210, the air in the space drying unit 420 is blocked, and the patient sample is introduced into input 210. At the atmospheric input at 270, air from the atmosphere is received sequentially through the space drying unit 420, humidity sensor 410, pump 400, variable flow valve 390, flow sensor 380, and finally atmospheric air valve 370, which supplies atmospheric air to the second valve 270 while releasing excess air back into the atmosphere.

[0029] The patient sample 210 / atmospheric air combination is passed from the second valve 270 to the three-way valve 280, which splits the patient sample 210 / atmospheric air combination into two pathways. The first pathway leads from valve 280 through a third valve 290, which further outputs to the atmosphere and also to the hydrogen sulfide storage coil 300. Valve 290 (optionally) is preferably a pressure valve to provide an appropriate sample volume to the H2S storage coil 300. Similarly, after the hydrogen sulfide coil 300 (optionally), the patient sample 210 / atmospheric air combination reaches a fourth valve 310 (optionally a pressure valve to provide an appropriate sample volume to the H2S storage coil 300), which separates the patient sample 210 / atmospheric air, sending the excess to the atmosphere and the remainder to the hydrogen sensor module 320 for hydrogen sulfide testing.

[0030] The patient sample 210 / atmospheric air combination is also connected from a three-way valve 280 to valve 330, which further outputs to the atmosphere and also to storage coil 340. In an alternative embodiment, unit 340 may be a molecular sieve column (separation column). After storage coil 340, the patient sample 210 / atmospheric air combination is transferred to a sixth valve 350, which separates the patient sample 210 / atmospheric air combination, sending the excess to the atmosphere and the remainder to sensor module 360, which outputs to the atmosphere.

[0031] Sensor modules 320 and 360 provide signals to a computer / display device, such as those disclosed in U.S. Patent No. 9,140,685, which is incorporated herein by reference. The system is coupled at selected locations for monitoring and control via a connection, preferably between, for example, the computer / display unit and: sample pumps 230, 400; humidity sensors 240 / 410; flow sensors 250 / 380; valves 260, 270, 310, 330, 370; and hydrogen sulfide sensor module 320 and second sensor module 360.

[0032] The foregoing description is intended only to illustrate the principles of the invention. Furthermore, since numerous modifications and variations will readily occur to those skilled in the art, it is not intended to limit the invention to the exact constructions and operations shown and described. While preferred embodiments have been described, details may be altered without departing from the invention.

Claims

1. A breath test device, comprising: The patient sample input terminal is used to receive the exhaled breath from the patient. Atmospheric input end, which is used to receive atmospheric air; A valve, which is connected to the patient sample input terminal and the atmospheric input terminal; Hydrogen sulfide sensor module; Second sensor module; The first passage from the valve to the hydrogen sulfide sensor module; A second passage from the valve to the second sensor module; The breath test device described herein includes the following features: 1) A first pump and a second pump, wherein the first pump is located between the patient sample inlet and the valve, and the second pump is located between the atmospheric inlet and the valve; 2) A first humidity sensor and a second humidity sensor, wherein the first humidity sensor is located between the patient sample input terminal and the valve, and the second humidity sensor is located between the atmospheric input terminal and the valve; 3) A variable airflow valve and a flow sensor, the flow sensor being located between the atmospheric inlet and the valve; and 4) A first pressure relief valve and a second pressure relief valve, wherein the first pressure relief valve vents air to the atmosphere between the patient sample input end and the valve, and the second pressure relief valve vents air to the atmosphere between the atmosphere input end and the valve.

2. The breath test apparatus of claim 1, further comprising a computer connected to the hydrogen sulfide sensor module and the second sensor module.

3. The breath test device of claim 1, further comprising a first drying unit and a second drying unit, the first drying unit being located between the first pump and the patient sample input terminal, and the second drying unit being located between the atmospheric input terminal and the second pump.

4. The breath test device as claimed in claim 1, wherein the first passage includes a three-way valve and a hydrogen sulfide storage coil.

5. The breath test apparatus of claim 1, wherein the second passage comprises at least one of a standard storage coil or a molecular sieve separation column.

6. The breath test device as claimed in claim 1, wherein the second sensor module comprises at least one of a hydrogen sensor, a methane sensor, and a carbon dioxide sensor.

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