KR-102962939-B1 - Breath gas analysis

KR102962939B1KR 102962939 B1KR102962939 B1KR 102962939B1KR-102962939-B1

Abstract

A system and method have been developed for the implementation of a breath test system for the convenient sampling of intestinal gas exhaled from a patient's breath. This may include a system having a manifold containing thermal control components, such as a thermistor and a resistive heating element, that maintain the temperature of the gas above the patient's body temperature. In some examples, the system will determine whether the patient has SIBO by adjusting for changes in the exhaled hydrogen concentration based on the exhaled methane level.

Inventors

피멘텔 마크
맥칼럼 케네스
굽타 카필
레자이에 알리
앨런 니컬러스 데이비드
돌베르 크리스토퍼 다이크
시로턱 나이절 앤서니
켈링휴센 마틴 유르겐
드리릭 마크 사샤
멀러 네이선 존

Assignees

세다르스-신나이 메디칼 센터

Dates

Publication Date: 20260511
Application Date: 20201216
Priority Date: 20191217

Claims (20)

As a system configured to determine the concentration of various gases from a single breath sample from a patient, A mouthpiece through which the patient blows air; A breath collector configured to receive the patient's breath through a mouthpiece coupled to the breath collector; Gas inlet that can be connected to a breath collector; Gas outlet; A manifold including a gas flow path communicating with a gas inlet and a gas outlet; A multi-gas sensor configured to measure the concentrations of various gases, including CH₄ , CO₂ , H₂ , and H₂S , simultaneously with a single breath sample, wherein each gas sensor is configured to output sensor data regarding the concentrations of different gases in a breath sample passing through a gas flow path, and the multi-gas sensor includes a CH₄ sensor, a CO₂ sensor, an H₂ sensor, and an H₂S sensor, wherein the CH₄ sensor is located separately from the manifold, and the CO₂ sensor, the H₂ sensor, and the H₂S sensor are located in series along a gas flow path including a single channel within the manifold; A heating element that communicates heat with the manifold; A temperature sensor configured to output temperature data related to the temperature of the manifold; A control system comprising a memory and one or more processors for determining the concentration of a gas based on output sensor data, wherein the output sensor data includes data output from a CH₄ sensor, a CO₂ sensor, an H₂ sensor, and an H₂S sensor; and A system including a display that outputs a determined gas concentration.
A system according to claim 1, further comprising a user interface configured to receive from the patient symptoms experienced by the patient among a predefined category of symptoms including abdominal distension, constipation, and diarrhea.
In paragraph 2, the control system is configured to store information regarding the time and content of the meal consumed by the patient prior to the breath sample test in the memory, and to output the correlation between the consumed food, symptoms, and the determined gas concentration to the display.
A system according to paragraph 3, wherein the first baffle is positioned adjacent to the H2 sensor and the second baffle is positioned adjacent to the H2S sensor, and the first and second baffles are specified in size and shape to facilitate gas exchange with the H2S sensor and the H2 sensor.
A system according to claim 1, further comprising a pump configured to pump gas through a gas flow path based on feedback from a flow meter configured to detect the flow rate through the gas flow path.
A system according to claim 1, wherein the temperature sensor is a thermistor connected to a printed circuit board.
In paragraph 6, the heating element is connected to a printed circuit board, in a system.
In claim 6, the heating element comprises a trace printed on a printed circuit board, in a system.
A system according to paragraph 4, wherein the heating element comprises a plurality of heating elements, and each of the plurality of heating elements is configured to heat one of the zone sets of the manifold.
A system according to claim 9, wherein the temperature sensor comprises a plurality of temperature sensors, and each of the plurality of temperature sensors is configured to output temperature data regarding one of the zone sets of the manifold.
In claim 1, the control system is configured to maintain a minimum temperature of the manifold by supplying power to a heating element based on data output from a temperature sensor.
A system according to claim 1, wherein the manifold comprises a metal block and the gas flow path is configured through the metal block.
In claim 1, the system wherein the manifold comprises a thermally conductive material, stainless steel, or copper.
In paragraph 1, the system is a portable system.
A system according to claim 1, wherein the gas flow path comprises a baffle located adjacent to at least one gas sensor.
In paragraph 11, the system wherein the minimum temperature is 40 degrees Celsius or between 38 and 41 degrees Celsius.
A system according to claim 1, further comprising a flow meter configured to provide the patient with feedback regarding appropriate breathing intensity according to the breath received through the mouthpiece.
A system according to claim 1, wherein the control system is configured to determine whether the patient has small intestine bacterial overgrowth (SIBO) based on output sensor data including concentrations of CH₄ , CO₂ , H₂ , and H₂S simultaneously measured from a single breath sample received from the patient.
A system according to claim 1, capable of simultaneously measuring the concentrations of various gases including CH₄ , CO₂ , H₂ , and H₂S in the same system by integrating a manifold and multiple gas sensors.
A system according to claim 1, wherein the control system is further configured to output an indication of diarrhea in the patient when output sensor data indicates an increase in the H2S level.

Description

Breath gas analysis Cross-reference regarding related applications This application claims priority to U.S. provisional application No. 62/949,057 filed on December 17, 2019, under the title of the invention of breath gas analysis, the contents of which are incorporated herein by reference. Field of invention The present invention relates to a system and method for analyzing gases exhaled from a patient's breath. The following description contains information that may be useful for understanding the present invention. It is not an admission that the information provided herein is prior art, related to the presently claimed invention, or that any publication specifically or implicitly referenced constitutes prior art. The human gastrointestinal tract typically contains billions of bacterial cells that aid digestion, but they can be harmful if they grow too large. These bacteria feed on the food humans consume and produce both beneficial and harmful byproducts. Bacteria are generally thousands of times less dominant in the small intestine than in the large intestine. However, in some patients experiencing small intestinal bacterial overgrowth ("SIBO"), the number of bacteria in the small intestine increases to the point where it approaches the volume of the large intestine. SIBO causes excessive gas production, which can lead to discomfort and unpleasant symptoms in patients. For example, patients with excessive gas production may experience abdominal pain, bloating, excessive belching, gas, general discomfort, and nausea. SIBO is thought to affect a significant number of adults (about 10%). Research (such as that disclosed in U.S. Patent No. 8,388,935) has identified broad but incompletely defined relationships between SIBO and numerous conditions, such as irritable bowel syndrome (IBS), fibromyalgia, chronic pelvic pain syndrome, depression, mental disorders, bad breath, tinnitus, sugar cravings, autism, attention deficit/hyperactivity disorder, drug sensitivity, autoimmune diseases, and Crohn's disease. Using currently available tools, caregivers have been able to associate SIBO with some of these conditions in specific patients. However, unfortunately, since each patient's bacterial environment is quite unique, achieving universal correlations is difficult, if not impossible. Therefore, a single test in the laboratory is rarely conclusive for diagnostic purposes. Numerous studies have revealed that the concentrations of exhaled CH4 and H2 are associated with SIBO, although they appear to be affected somewhat differently in all patients. For example, concentrations in the range of CH4 (-1–50 ppm) and H2 (-1–50 ppm) have been shown to be clinically significant. Furthermore, excessive methane production has been shown to be associated with obesity, and excessive gas production with irritable bowel syndrome. Recently, interest in SIBO has been increasing due to its strong association with irritable bowel syndrome. Additionally, high levels of methane indicate SIBO, which causes constipation. Currently, SIBO is diagnosed using a predetermined diet prior to laboratory testing of the patient's exhaled gas. For example, the patient may take carbohydrates such as lactulose (typically 10 g) or glucose (typically 50 g). Then, after ingestion, hydrogen is analyzed in the patient's breath samples, typically every 15–20 minutes, for up to 3 hours. If glucose is administered to the patient, a positive test is indicated if the hydrogen concentration increases by more than 10 ppm (parts per million) above the baseline level. Lactulose is a sugar digested by colon bacteria rather than the human host. Ingested lactulose must pass through the small intestine undigested and reach the colon, where bacteria produce gas. In healthy individuals, there is a single peak of gas in the breath following lactulose ingestion when the lactulose enters the colon. Individuals with SIBO may produce two significant gas peaks in their breath. The first abnormal peak occurs when lactulose passes through gas-producing bacteria in the small intestine, and the second normal peak occurs when lactulose enters the colon. If baseline hydrogen levels increase by more than 20 ppm after lactulose ingestion, this may indicate a positive test. Recently, many studies have demonstrated the limitations of using lactulose for SIBO diagnosis, primarily due to high false-positive rates. Hydrogen breath testing can diagnose only 60% of SIBO patients. There has been much less work on combined methane/hydrogen detection to improve SIBO diagnosis. There is even less work on measuring hydrogen sulfide in conjunction with methane and hydrogen detection. Therefore, there is still a need in the industry for devices or systems to measure these hydrogen, methane, and hydrogen sulfide individually or in combination. Therefore, the consumption of specific foods has been shown to be associated with increased gas production linked to various diseases, including SIBO. However