WO2021177923A1

WO2021177923A1 - Sleep apnea diagnostic device

Info

Publication number: WO2021177923A1
Application number: PCT/TR2021/050183
Authority: WO
Inventors: Atila YILMAZ
Original assignee: Hacettepe Universitesi
Current assignee: Hacettepe Universitesi
Priority date: 2020-03-03
Filing date: 2021-03-02
Publication date: 2021-09-10
Anticipated expiration: 2022-09-03
Also published as: GB2609109A; TR202003230A2; GB2609109B; GB202214154D0

Abstract

The present invention relates to a diagnostic device (1) for performing detection of apnea episodes by gathering data associated with pre-diagnosis of sleep apnea syndrome disease without contacting the patient.

Description

SLEEP APNEA DIAGNOSTIC DEVICE Technical Field

The present invention relates to a diagnostic device for performing detection of apnea episodes by gathering data associated with pre-diagnosis of sleep apnea syndrome disease without contacting the patient.

Background of the Invention

Sleep apnea is expressed as cease of person’s respiration during sleep. Sleep apnea, which means stop of breath and being superficial during sleep, may repeat multiple times throughout the night. During sleep apnea, deformation in muscles that enable upper respiratory tract to remain open plays an important role. Inability to breathe for at least 10 seconds due to the fact that tongue base or soft palate or excessively enlarged tonsils obstruct the airway is called as obstructive sleep apnea. Testing of sleep apnea is the most significant step in the detection and treatment process of the problem. A sleep apnea test called as "polysomnography" is an examination whereby brain activity and respiratory events are recorded all night long. This test is based on measurement of brain waves, eye movements, airflow from mouth and nose, snoring, heart rate, leg movements and oxygen levels during sleep. Patients must stay in a sleep room overnight in order to have a sleep apnea test. During the test, signals received by electrodes connected to various parts of the body are transferred to a computer outside the room. By examining these signals recorded all night, various parameters are taken into consideration such as how many times did breathing stop during sleep, how long did it stop, how did it affect oxygen values and heart rate when it stopped, and whether s/he fell into deep sleep. Patients can be diagnosed by means of polysomnography device with a very high success rate. Important information such as electrocardiography, nasal airflow, chest and abdominal movements, EEG and oxygen saturation are collected and processed in this method of multi-channel physiological signal recording. Record of breath movements, which is the most important information among these signals, is displayed via thermistor or nasal cannula. However, the fact that patients are wrapped up by cable or electrode connections, feel uncomfortable and have difficulty in falling into deep sleep are critical issues in this approach. Therefore, formation of unqualified data records for some cases and complications in sleeping rooms -wherein it is quite difficult for one’s turn to come- are the most important problems. In addition, considering the long waiting periods, the need for repetition of problematic records arising from the fact that patients cannot fall into deep sleep due to cables wrapped and mask discomfort in such environments is an important issue. For this reason, new diagnostic devices and technical approaches are needed for preventing patients from feeling discomfort during test.

The Chinese patent document no. CN104257353, an application in the state of the art, discloses a sleep apnea syndrome detecting system. The system comprises a sleep respiration detection device, a processing and diagnosing device, a sensor group. The sensor group contains one positive electrode and one negative electrode for detecting body chest breathing of a human body and electrocardiogram signals, and a thermistor sensor for detecting nasal breathing airflow. The sleep breathing detection device comprises a protection circuit, an impedance type respiration detection module, an electrocardiographic signal detection module, an acceleration detection module, an oral-nasal breathing detection module, a processor module and a wireless communication module. The thermistor sensor is connected with the oral-nasal breathing detection module. The impedance type respiration detection module is connected with the acceleration detection module, the oral-nasal breathing detection module, the processor module and the wireless communication module. The processing and diagnosis device comprises a data processing module, a data storage and playback module, a real-time monitoring and abnormal alarm module, and a diagnosis and report module. The data processing module receives and processes various types of signals sent by the detection device. The processed data is stored and played back in the data storage and playback module. The real-time detection and abnormal alarm module detects abnormalities of respiration and electrocardiogram and alarms. A report is generated by the diagnosis and report module about the condition being diagnosed. The acceleration detection module provides a function of an abdominal breathing state and a function of sleep body state during sleep. The abdominal breathing state is acquired through changes of value detected by the sensor and they are transmitted to the processor. The positive and negative electrodes are used for applying an excitation signal of the impedance type respiration detection module to a human body and simultaneously for measuring impedance by detecting chest breathing signal. Whereas the thermistor sensor detects the temperature change of the nasal breathing and the oral breathing by the oral and nasal breathing module and transmits the acquired signal to the processor module. The processor module performs sleep apnea detection and classification by means of its diagnosis monitoring software. It implements this transaction via smartphone or computer. Use of the device does not require hospitalization. In other words, it is a simple portable device wherein electrodes are utilized which can be used at home for detection and classification of sleep apnea syndrome.

The Japanese patent document no. JP2009532072, an application in the state of the art, discloses a system and method which may assist a patient or a health-care provider in order to treat patients and is used for monitoring patients for occurrence or recurrence of a physiological condition such as a chronic disease or disorder. The chronic medical condition being monitored can be asthma, apnea, insomnia, congestive heart failure, hypoglycaemia and etc. Thus, the system comprises use of a motion collection module, a pattern analysis module and an output module. The system enables to carry out measurements such as heart rate and respiratory rate as contact-free by means of microphone and motion sensors during sleep. Besides, it measures body motion signals as well. Patients are monitored in bed in order to detect whether the body posture has been changed or not.

Summary of the Invention

An objective of the present invention is to realize a diagnostic device for performing detection of disease by gathering data in accordance with pre diagnosis of sleep apnea syndrome disease without contacting the patient.

Another objective of the present invention is to realize a diagnostic device for detecting sleep apnea by measuring and recording changes of temperature in the mouth-nose area occurring as a result of breathing, remotely.

Another objective of the present invention is to realize a diagnostic device for monitoring breathing activities indirectly without the need for electrodes, masks or thermometers attached to the nose-mouth area about which patients complaint during detection of sleep apnea.

Another objective of the present invention is to realize a diagnostic device for eliminating problematic records arising from the fact that patients cannot fall into deep sleep due to cables wrapped and mask discomfort in sleep rooms in order to carry out the test procedure.

Another objective of the present invention is to realize a diagnostic device for eliminating negative results created on records due to the fact that patients move their head during sleep, by monitoring the patients’ head who are asleep while performing the sleep apnea test. Detailed Description of the Invention

“ A Sleep Apnea Diagnostic Device” realized to fulfil the objectives of the present invention is shown in the figures attached, in which:

Figure l is a general view of the inventive sleep apnea diagnostic device. Figure 2 is a chart of a continuous breathing pattern of a patient who is monitored by the inventive sleep apnea diagnostic device.

Figure 3 is a chart of intervals where the patient who is monitored by the inventive sleep apnea diagnostic device stops breathing.

The components illustrated in the figures are individually numbered, where the numbers refer to the following:

1. Device

2. Sensor

3. First support member

4. Second support member

5. Microcontroller

6. Computer

H: Patient Y: Bed

The inventive diagnostic device (1) for performing detection of disease by gathering data in accordance with pre-diagnosis of sleep apnea syndrome disease without contacting the patient (H) comprises:

- at least one sensor (2) which enables to detect changes of temperature occurring as a result of breathing in the mouth-nose area of the patient (H) who lies in the bed (Y) wherein the patient (H) to be tested for sleep apnea is lied down in parallel to the floor; - at least one first support member (3) which encloses the head part of the patient (H) who lies in the bed (Y) such that a space will remain with the head part, and whereon at least one sensor (2) is located;

- at least one second support member (4) which is located between the head part of the patient (H) who lies in the bed (Y) and the first support member (3), and enables to distinguish the changes of temperature occurring in the mouth-nose area of the patient (H) from the basis temperature of body by creating an interface between the first support member (3) and the patient (H);

- at least one microcontroller (5) which enables to keep the data of temperature change detected by means of the sensor (2) and to determine the optimum sensor (2) for measurement; and

- at least one computer (6) enables to receive the data in the microcontroller (5) and to detect sleep apnea by processing it by means of software.

The sensor (2) included in the inventive system (1) is placed onto the first support member (3) in a desired number and density in the form of an array. The sensor (2) is configured to measure the change of temperature occurring in the mouth- nose area during breathing of the patient (H) who lies in the bed (Y) and is asleep, over the microcontroller (5) located on the patient’s (H) head instead of receiving it directly from the mouth-nose area of the patient (H). Increasing the number of sensors (2) placed onto the first support member (3) enables to perform temperature monitoring on the patient (H) more stably and precisely. The sensor (2) is in contact with the microcontroller (5) in order to transmit the data received about the changes of temperature occurring in the mouth-nose area, to the microcontroller (5) by means of its cable connections. In a specimen of the invention, the sensor (2) is a thermal sensor of preferably MEMS Termal Infrared OMRON D6T-44L-06 model and a semiconductor material for detecting array temperature in a 4x4 matrix layout is located on these sensors. The first support member (3) included in the inventive system (1) holds and supports the sensors (2), and a sensor (2) can be placed onto it in a desired number and density. The first support member (3) is in the form of a semi-circular and ensures that the distance between the sensors (2) performing the measurement and the patient’s (H) head remains the same in the event that the patient (H) changes the direction of his/her head during sleep. The first support member (3) is positioned such that it will keep the patient’s (H) head who lies in the bed (Y), in its center. The edges of the first support member (3) are preferably located on the same ground with the ground where the bed (Y) is located.

The second support member (4) included in the inventive system (1) whereby temperature changes of breath inhaled and exhaled by the patient (H) are transmitted. The second support member (4) is located between the first support member (3) and the head part of the patient (H) who lies in the bed (Y) and it does not contact with the patient’s (H) head and the first support member (3). The second support member (4) is in the form of a semi-circular and ensures that temperature of the mouth-nose area to be measured by the sensors (2) is in the same distance with each sensor (2), in the event that the patient (H) changes the direction of his/her head during sleep. The second support member (4) is positioned such that it will keep the head part of the patient (H) who lies in the bed (Y) in its center. The edge of the second support member (4) is preferably located on the same ground with the ground where the bed (Y) is located. The second support member (4) is made of paper that is a material reacting to the temperature change to be detected by means of the sensor (2) in the fastest way instead of a material that conduct temperature quickly and sensitively such as metal or a similar material, and preventing the basis temperature on the face by not detecting it while it is in a remote area. The second support member (4) exhibits characteristic of heating and cooling very close to actual physiological signal change due to the fact that it is made of paper, and ensures that position and time information of temperature change can be recorded by the sensors (2) without impairment because it does not keep the temperature on it and does not conduct it like metals. The second support member (4) is used for distinguishing the breathing temperature of the patient (H) that occurs as a result of breathing, from the basis temperature on the face. The second support member (4) is configured to create an interface between the sensors (2) and the patient’s (H) face and to ensure that the change of temperature in the mouth-nose area is recorded in a healthy way. The second support member (4) enables to avoid measuring the change of temperature occurring in the mouth-nose area of the patient (H), directly with the sensor (2).

A cable connection is located between the sensor (2) and the microcontroller (5) included in the inventive system (1). The microcontroller (5) is configured to keep the data of temperature change received from the mouth-nose area of the patient (H) who is asleep by means of a plurality of sensor (2) arrays, and to process these data. The microcontroller (5) is configured to manage the temperature data by a multiplexing unit and then to transmit these to the computer (6). The microcontroller (5) is configured to make comparisons of signal magnitude that is required to continue gathering data by the sensor (2) having the largest signal size according to the change in the magnitude of the temperature signal received from the sensors (2) upon the patient (H) turns his/her head during sleep by means of the software it has. In other words, the microcontroller (5) is configured to ensure that a sensor (2) in the optimum position is automatically selected due to the signal intensity and then this record is continued over this sensor (2).

The computer (6) included in the inventive system (1) is in contact with the microcontroller (5) and it is configured to process the data that it receives from the microcontroller (5) by means of 12C port, via its software; and to estimate apnea intervals through apnea detection procedures by recording breathing stops or decreases of 10 seconds at minimum; and to calculate apnea/hypapnea index. In an embodiment of the invention, the computer (6) enables to diagnose complex obstructive apnea (obstructive respiratory arrest) by means of a software being run on thereof. Charts which comprise data about the changes of termperture in the mouth-nose area, the breathing pattern and the interval of stop of breath of the patient (H) that are detected independently of the head direction are provided in the Figure 2 and 3. The Figure 2 includes a regular graph in the chart for regular breathing intervals and graph irregularities are present in intervals where breathing stops in the Figure 3.

The inventive diagnostic device (1) can be used in hospital or home environment without any contact with the patient (H) in order to perform a pre-diagnosis of apnea. The diagnostic device (1) focuses on changes of temperature arising from breathing in the mouth-nose area of the patient (H) for diagnosis of apnea. In addition, the diagnostic device (1) discriminates between the basis temperature of body and the temperature difference arising from breathing by means of its second support member (4). Besides, the diagnostic device (1) eliminates problems such as the patient (H) who needs to sleep during apnea diagnosis feel uncomfortable and have difficulty in falling into deep sleep because s/he is wrapped up by cable or electrical connections; and thereby formation of unqualified data records and the need to repeat the sleep test in sleeping rooms -wherein it is difficult for one’s turn to come- are avoided. Within these basic concepts; it is possible to develop various embodiments of the inventive sleep apnea diagnostic device (1); the invention cannot be limited to examples disclosed herein and it is essentially according to claims.

Claims

1. A diagnostic device (1) for performing detection of disease by gathering data in accordance with pre-diagnosis of sleep apnea syndrome disease without contacting the patient (H); characterized by at least one sensor (2) which enables to detect changes of temperature occurring as a result of breathing in the mouth-nose area of the patient (H) who lies in the bed (Y) wherein the patient (H) to be tested for sleep apnea is lied down in parallel to the floor; at least one first support member (3) which encloses the head part of the patient (H) who lies in the bed (Y) such that a space will remain with the head part, and whereon at least one sensor (2) is located; at least one second support member (4) which is located between the head part of the patient (H) who lies in the bed (Y) and the first support member (3), and enables to distinguish the changes of temperature occurring in the mouth-nose area of the patient (H) from the basis temperature of body by creating an interface between the first support member (3) and the patient (H); at least one microcontroller (5) which enables to keep the data of temperature change detected by means of the sensor (2) and to determine the optimum sensor (2) for measurement; and at least one computer (6) enables to receive the data in the microcontroller (5) and to detect sleep apnea by processing it by means of software.

2. A diagnostic device (1) according to Claim 1; characterized by the sensor (2) which is placed onto the first support member (3) in a desired number and density in the form of an array.

3. A diagnostic device (1) according to Claim 1 or 2; characterized by the sensor (2) which is configured to measure the change of temperature occurring in the mouth-nose area during breathing of the patient (H) who lies in the bed (Y) and is asleep, over the microcontroller (5) located on the patient’s (H) head instead of receiving it directly from the mouth-nose area of the patient (H).

4. A diagnostic device (1) according to any of the preceding claims; characterized by the first support member (3) which enables to perform temperature monitoring on the patient (H) more stably and precisely upon the number of sensors (2) placed thereof is increased.

5. A diagnostic device (1) according to any of the preceding claims; characterized by the sensor (2) which is in contact with the microcontroller (5) in order to transmit the data received about the changes of temperature occurring in the mouth-nose area, to the microcontroller (5) by means of its cable connections.

6. A diagnostic device (1) according to any of the preceding claims; characterized by the sensor (2) a specimen of which is a thermal sensor of preferably MEMS Termal Infrared (e.g. OMRON D6T-44L-06 model), and whereon a semiconductor material for detecting array temperature in a 4x4 matrix layout is located.

7. A diagnostic device (1) according to any of the preceding claims; characterized by first support member (3) which holds and supports the sensors (2), and whereon a sensor (2) can be placed in a desired number and density.

8. A diagnostic device (1) according to any of the preceding claims; characterized by the first support member (3) which is in the form of a semi-circular and ensures that the distance between the sensors (2) performing the measurement and the patient’s (H) head remains the same in the event that the patient (H) changes the direction of his/her head during sleep.

9. A diagnostic device (1) according to any of the preceding claims; characterized by first support member (3) which is positioned such that it will keep the patient’s (H) head who lies in the bed (Y), in its center.

10. A diagnostic device (1) according to any of the preceding claims; characterized by the first support member (3) the edges of which are located on the same ground with the ground where the bed (Y) is located.

11. A diagnostic device (1) according to any of the preceding claims; characterized by the second support member (4) whereby temperature changes of breath inhaled and exhaled by the patient (H) are transmitted.

12. A diagnostic device (1) according to any of the preceding claims; characterized by the second support member (4) which is located between the first support member (3) and the head part of the patient (H) who lies in the bed (Y) and it does not contact with the patient’s (H) head and the first support member (3).

13. A diagnostic device (1) according to any of the preceding claims; characterized by the second support member (4) which is in the form of a semi-circular and ensures that temperature of the mouth-nose area to be measured by the sensors (2) is in the same distance with each sensor (2), in the event that the patient (H) changes the direction of his/her head during sleep.

14. A diagnostic device (1) according to any of the preceding claims; characterized by the second support member (4) which is positioned such that it will keep the head part of the patient (H) who lies in the bed (Y) in its center.

15. A diagnostic device (1) according to any of the preceding claims; characterized by the second support member (4) the edge of which is located on the same ground with the ground where the bed (Y) is located.

16. A diagnostic device (1) according to any of the preceding claims; characterized by the second support member (4) which is made of paper that is a material reacting to the temperature change to be detected by means of the sensor (2) in the fastest way instead of a material that conduct temperature quickly and sensitively such as metal or a similar material, and preventing the basis temperature on the face by not detecting it while it is in a remote area.

17. A diagnostic device (1) according to any of the preceding claims; characterized by the second support member (4) which exhibits characteristic of heating and cooling very close to actual physiological signal change due to the fact that it is made of paper, and ensures that position and time information of temperature change can be recorded by the sensors (2) without impairment because it does not keep the temperature on it and does not conduct it like metals.

18. A diagnostic device (1) according to any of the preceding claims; characterized by the second support member (4) which is used for distinguishing the breathing temperature of the patient (H) that occurs as a result of breathing, from the basis temperature on the face.

19. A diagnostic device (1) according to any of the preceding claims; characterized by the second support member (4) which is configured to create an interface between the sensors (2) and the patient’s (H) face and to ensure that the change of temperature in the mouth-nose area is recorded in a healthy way.

20. A diagnostic device (1) according to any of the preceding claims; characterized by the second support member (4) which enables to avoid measuring the change of temperature occurring in the mouth-nose area of the patient (H), directly with the sensor (2).

21. A diagnostic device (1) according to any of the preceding claims; characterized by the microcontroller (5) wherein a cable connection is located between the sensor (2) and itself.

22. A diagnostic device (1) according to any of the preceding claims; characterized by the microcontroller (5) which is configured to keep the data of temperature change received from the mouth-nose area of the patient (H) who is asleep by means of a plurality of sensor (2) arrays, and to process these data.

23. A diagnostic device (1) according to any of the preceding claims; characterized by the microcontroller (5) which is configured to manage the temperature data by a multiplexing unit and then to transmit these to the computer (6).

24. A diagnostic device (1) according to any of the preceding claims; characterized by the microcontroller (5) which is configured to make comparisons of signal magnitude that is required to continue gathering data by the sensor (2) having the largest signal size according to the change in the magnitude of the temperature signal received from the sensors (2) upon the patient (H) turns his/her head during sleep by means of the software it has.

25. A diagnostic device (1) according to any of the preceding claims; characterized by the microcontroller (5) which is configured to ensure that a sensor (2) in the optimum position is automatically selected due to the signal intensity and then this record is continued over this sensor (2).

26. A diagnostic device (1) according to any of the preceding claims; characterized by the computer (6) which is in contact with the microcontroller (5) and which is configured to process the data that it receives from the microcontroller (5) by means of I2C port, via its software; and to estimate apnea intervals through apnea detection procedures by recording breathing stops or decreases of 10 seconds at minimum; and to calculate apnea/hypapnea index.