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WO2016177350A1 - 基于生物阻抗的睡眠呼吸状态信号采集设备及监测系统 - Google Patents

基于生物阻抗的睡眠呼吸状态信号采集设备及监测系统 Download PDF

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Publication number
WO2016177350A1
WO2016177350A1 PCT/CN2016/081480 CN2016081480W WO2016177350A1 WO 2016177350 A1 WO2016177350 A1 WO 2016177350A1 CN 2016081480 W CN2016081480 W CN 2016081480W WO 2016177350 A1 WO2016177350 A1 WO 2016177350A1
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Prior art keywords
impedance
signal acquisition
data
signal
module
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English (en)
French (fr)
Inventor
戴涛
徐现红
高松
王奕刚
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Sealand Technology (chengdu) Ltd
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Sealand Technology (chengdu) Ltd
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Priority to US15/565,886 priority Critical patent/US20180110463A1/en
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/05—Detecting, measuring or recording for diagnosis by means of electric currents or magnetic fields; Measuring using microwaves or radio waves
    • A61B5/053—Measuring electrical impedance or conductance of a portion of the body
    • A61B5/0531—Measuring skin impedance
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/48—Other medical applications
    • A61B5/4806—Sleep evaluation
    • A61B5/4818—Sleep apnoea
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/0002—Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network
    • A61B5/0004—Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network characterised by the type of physiological signal transmitted
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/02—Detecting, measuring or recording for evaluating the cardiovascular system, e.g. pulse, heart rate, blood pressure or blood flow
    • A61B5/0205—Simultaneously evaluating both cardiovascular conditions and different types of body conditions, e.g. heart and respiratory condition
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/02—Detecting, measuring or recording for evaluating the cardiovascular system, e.g. pulse, heart rate, blood pressure or blood flow
    • A61B5/024—Measuring pulse rate or heart rate
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/02—Detecting, measuring or recording for evaluating the cardiovascular system, e.g. pulse, heart rate, blood pressure or blood flow
    • A61B5/024—Measuring pulse rate or heart rate
    • A61B5/0245—Measuring pulse rate or heart rate by using sensing means generating electric signals, i.e. ECG signals
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/05—Detecting, measuring or recording for diagnosis by means of electric currents or magnetic fields; Measuring using microwaves or radio waves
    • A61B5/053—Measuring electrical impedance or conductance of a portion of the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/08—Measuring devices for evaluating the respiratory organs
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/08—Measuring devices for evaluating the respiratory organs
    • A61B5/0803—Recording apparatus specially adapted therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/08—Measuring devices for evaluating the respiratory organs
    • A61B5/085—Measuring impedance of respiratory organs or lung elasticity
    • A61B5/086—Measuring impedance of respiratory organs or lung elasticity by impedance pneumography
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61B5/4815—Sleep quality
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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61B2560/02—Operational features
    • A61B2560/0204—Operational features of power management
    • A61B2560/0214—Operational features of power management of power generation or supply
    • A—HUMAN NECESSITIES
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    • A61B2560/02—Operational features
    • A61B2560/0266—Operational features for monitoring or limiting apparatus function
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/02—Details of sensors specially adapted for in-vivo measurements
    • A61B2562/0204—Acoustic sensors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
    • A61B5/316—Modalities, i.e. specific diagnostic methods
    • A61B5/318—Heart-related electrical modalities, e.g. electrocardiography [ECG]
    • A—HUMAN NECESSITIES
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    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6801—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be attached to or worn on the body surface
    • A61B5/683—Means for maintaining contact with the body
    • A61B5/6838—Clamps or clips
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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6801—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be attached to or worn on the body surface
    • A61B5/6843—Monitoring or controlling sensor contact pressure
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B7/00—Instruments for auscultation
    • A61B7/003—Detecting lung or respiration noise

Definitions

  • the invention belongs to the technical field of biomedical monitoring, and particularly relates to a bio-impedance-based sleep breathing state signal collecting device and a monitoring system.
  • Bioimpedance technology is a non-invasive detection technique that uses the electrical properties of biological tissues and organs to extract physiological and pathological information from human body. Different human tissues and organs have unique bioimpedance characteristics, and changes in the state or function of tissues and organs will also be accompanied by changes in corresponding bioimpedance characteristics. For example, in the prior art, the principle of synchronizing the degree of fatigue of the diaphragm with the chest respiratory electrical impedance signal and the peak of the abdominal respiratory electrical impedance signal is described, and the degree of diaphragmatic fatigue is divided into different types. Bioimpedance technology has the advantages of non-invasive, non-destructive, long-term real-time monitoring and low cost in clinical medicine, which makes bioimpedance technology have great potential and value in clinical medicine or health care.
  • sleep apnea refers to a sleep disorder in which sleep stops breathing. Specifically, more than 30 apneas occur during 7 hours of sleep, and each airflow stops for more than 10s (including 10s), or sleeps per hour. The number of apnea hypopneas (respiratory disorder index) exceeded 5 times, causing clinical syndrome of chronic hypoxemia and hypercapnia. It can be divided into central type, blocking type and hybrid type.
  • Obstructive sleep apnea-hypopnea syndrome is a soft tissue relaxation near the throat during sleep, causing upper airway stenosis or even obstruction and apnea; central sleep apnea-hypopnea syndrome , OSAHS), is related to the central nervous system dysfunction that controls breathing, and is driven by the central nervous system that temporarily loses respiratory function. This respiratory disorder is not caused by airway obstruction. Usually, the airway has no airflow for >10s, no chest. Abdominal breathing exercise; and a mixture of the two. According to statistics, the number of people with respiratory sleep disorders accounts for 2% to 4% of the total population, and the number is obvious. The trend of rising.
  • Sleep Apnea Hypopnea is a clinical syndrome in which a series of pathophysiological changes occur in a variety of causes, such as recurrent apnea/hypopnea, hypercapnia, and sleep disruption. Syndrome, SAHS).
  • SAHS sleep disruption. Syndrome
  • PSG polysomnography monitor
  • EEG electromyography
  • electromyography electromyography
  • PSG-based sleep breathing detection technology can accurately detect abnormal breathing, but this kind of detection means that the patient needs to wear a mask, chest and abdomen belt and more electrodes, which has a large physiological and psychological load on the patient, which is easy to produce " The first night effect "affects the results of sleep monitoring; moreover, the instrument is complicated to operate and expensive to detect.
  • a bio-impedance-based sleep breathing state signal acquisition device includes:
  • the signal acquisition unit comprises an electrode in contact with the chest of the human body, a thoracic impedance acquisition module connected to the electrode, a heart rate acquisition module connected to the electrode, and a click sound collection module.
  • the processing control unit is respectively connected to the chest impedance acquisition module, the heart rate acquisition module, and the click sound collection module, and is configured to convert the collected signal into a digital signal and control the normal or abnormal situation.
  • the object to be tested issues a corresponding prompt or warning;
  • a data storage unit coupled to the processing control unit, for storing digital signal data converted by the processing control unit
  • a wireless communication unit connected to the data storage unit, for wirelessly transmitting digital signal data to an external terminal;
  • the signal collection device further includes:
  • An LED lamp is connected to the processing control unit for displaying an operating state of the signal collecting device and a power state;
  • An output interface connected to the data storage unit, for outputting data collected by wires
  • a device housing for accommodating a protection signal acquisition unit, a processing control unit, a data storage unit, a wireless communication unit, and a power supply unit;
  • the plug port is connected to the chest impedance acquisition module and the heart rate acquisition module.
  • the signal acquisition device further includes a fixing clip, and the fixing clip is disposed on a surface of the device casing for fixing the signal collecting device of the human body in a state of sleep breathing.
  • the signal acquisition device further includes a fixing clip, and the fixing clip is disposed on a surface of the device casing for fixing the signal collecting device of the human body in a state of sleep breathing.
  • the electrode is an excitation electrode or an acquisition electrode.
  • the output interface and the plug port are disposed on the same side surface of the device housing.
  • the electrode is mounted on the electrode connector at one end of the wire, and the other end of the wire is provided with a connector connected to the plug port of the chest impedance acquisition module and the heart rate acquisition module.
  • the integrated lead wire connected to the wire and the wire is connected to the plug port of the chest impedance acquisition module and the heart rate acquisition module.
  • the acquisition front end of the click sound collection module is a microphone, and the microphone is located on a surface of the device casing.
  • the LED light when the LED light is displayed in red, it indicates that the signal collecting device is in a low battery state, prompting the user to charge or replace the battery; when the LED light is displayed in green, It indicates that the signal collecting device is fully charged and in a normal state, prompting the user to perform normal sleep breathing state monitoring; when the LED light is displayed in yellow, it indicates that the electrode of the signal collecting device is in poor contact with the human body, prompting the user that the electrode contact is faulty. Need to diagnose or readjust the contact between the electrode and the human body.
  • the present invention adopts a technical solution as follows:
  • a monitoring system comprising the bioimpedance-based sleep breathing state signal acquisition device described in the above technical solution, further comprising a terminal processing device wirelessly connected to the signal acquisition device.
  • the terminal processing device includes:
  • the data analysis module is wirelessly connected to the receiving signal collecting device, and is configured to receive the collected digital data and perform matching analysis on the chest impedance data and the heart rate data in the collected digital data, and simultaneously use the click data as the sleep state reference data;
  • a real-time data display module connected to the data analysis module and displaying a chest impedance, a heart rate, and a click curve;
  • the storage and playback module is connected to the real-time data display module and stores the collected data processing results for historical viewing.
  • the present invention has the advantages compared with the prior art: the technical solution adopts bioimpedance technology to acquire thoracic impedance and heart rate signals, and combines snoring audio signals to monitor sleep breathing state, and adopts wireless signal transmission to avoid
  • the patient's body is not easy to fall asleep or have a low degree of sleep and wake up at night;
  • the sleep breathing condition monitoring system is not only simple and cheap, easy to wear, suitable for home use, but also does not affect sleep
  • the test environment is a daily real sleep environment. In order to achieve real-time monitoring of the patient's real daily sleep breathing state under the influence of actions such as changes in sleep posture.
  • FIG. 1 is a schematic structural diagram of a sleep breathing state signal acquisition device according to Embodiment 1 of the present invention.
  • FIG. 2 is a front view of a sleep breathing state signal collecting device according to Embodiment 1 of the present invention.
  • FIG. 3 is a side view of a sleep breathing state signal acquisition device according to Embodiment 1 of the present invention.
  • FIG. 4 is a schematic structural diagram of a lead wire of a sleep breathing state signal collecting device according to Embodiment 1 of the present invention.
  • FIG. 5 is a top plan view of a sleep breathing state signal collecting device (not plugged lead wire) according to Embodiment 1 of the present invention.
  • FIG. 6 is a schematic diagram showing a connection relationship between a sleep breathing state monitoring system and a human body according to Embodiment 2 of the present invention.
  • FIG. 7 is a schematic structural diagram of a sleep breathing state monitoring system according to Embodiment 2 of the present invention.
  • Figure 8 is a graph showing changes in chest impedance (breath) of a sleep breathing state monitoring system according to a second embodiment of the present invention.
  • FIG. 9 is a graph showing a heart rate change curve of a sleep breathing state monitoring system according to Embodiment 2 of the present invention.
  • FIG. 10 is a diagram showing a decibel decibel curve of a sleep breathing state monitoring system according to Embodiment 2 of the present invention.
  • 100-signal acquisition device 101-signal acquisition unit, 1011, 1012-electrode, 1011', 1012'-electrode connector, 1013-thoracic impedance acquisition module, 1014-heart rate acquisition module, 1015-click acquisition module, 1016-plug connector , 1017 - microphone, 102 - processing control unit, 103 - data storage module, 104 - wireless communication unit, 105 - LED light, 106 - output interface, 107 - device housing, 108 - fixed clip, 109 - plug port, 200 - Terminal Processing Equipment, 201 - Data Analysis Module, 202 - Real Time Data Display Module, 203 - Storage and Playback Module.
  • the sleep breathing state signal acquisition device and the monitoring system mainly use bioimpedance technology to acquire a sleep breathing monitoring signal, and simultaneously collect a click sound as a reference signal, thereby being used for detecting an apnea time in a human sleep state,
  • the classification diagnosis of sleep apnea syndrome and sleep quality assessment are especially suitable for self-monitoring of sub-health populations.
  • the following description is only a preferred embodiment of the invention and is not intended to limit the scope of the invention.
  • Embodiment 1 is a diagrammatic representation of Embodiment 1:
  • an embodiment of the present invention provides a bio-impedance-based sleep breathing state signal acquisition device 100, including a signal acquisition unit 101, a processing control unit 102, a data storage unit 103, and a wireless communication unit 104.
  • the signal acquisition unit 101 includes two electrodes 1011 and 1012 that are in contact with at least a human body chest, a thoracic impedance acquisition module 1013 connected to the electrode 1011 or 1012, and a heart rate acquisition module 1014 connected to the electrode 1011 or 1012.
  • the two electrodes 1011 and 1012 can be the excitation electrode and the collection electrode, and the two electrodes are simultaneously excited to simultaneously collect.
  • the processing control unit 102 is connected to the chest impedance collecting module 1013, the heart rate collecting module 1014, and the click sound collecting module 1015, respectively, for converting the collected signals into digital signals.
  • the data storage unit 103 is connected to the processing control unit 102 for storing digital signal data converted by the processing control unit.
  • the wireless communication unit 104 is connected to the data storage unit 103 for wirelessly transmitting digital signal data to an external terminal.
  • Each of the above units has a power supply unit (not shown), such as an external power supply or a built-in battery.
  • a power switch connected to the power supply unit can be set.
  • the signal acquisition device 100 further includes an LED lamp 105, an output interface 106, a device housing 107, and a docking port 109.
  • the LED lamp 105 is connected to the processing control unit 102 for displaying the working state and the power state of the signal collecting device 100.
  • the LED lamp 105 When the LED lamp 105 is displayed in red, it indicates that the signal collecting device 100 is in a low battery state, prompting the user to charge or replace the battery; when the LED lamp 105 is displayed in green, it indicates that the signal collecting device 100 is fully charged and in a normal state.
  • the state prompts the user to perform normal sleep breathing state monitoring; when the LED light 105 is displayed in yellow, it indicates that the electrode of the signal collecting device 100 is in poor contact with the human body, prompting the user that the electrode contact is faulty needs to diagnose or re-adjust the electrode and Human contact area.
  • the output interface 106 is connected to the data storage unit 103 for wired output data acquisition; and the device housing 107 is used to accommodate the protection signal acquisition unit 101, Processing control unit 102, data storage unit 103, and wireless communication Signal unit 104.
  • the signal acquisition unit 101, the processing control unit 102, the data storage unit 103, and the wireless communication unit 104 are integrated on a circuit board; the plug port 109 and the chest impedance collection module 1013 and heart rate The acquisition module 1014 is connected.
  • the output interface 106 and the plug-in port 109 are disposed on the same side surface of the device housing 107.
  • the signal acquisition device 100 further includes a fixing clip 108, and the fixing clip 108 is disposed on the surface of the device housing 107 for fixing the signal collecting device of the human body in a sleep breathing state. 100.
  • the electrode 1011 (or 1012) is mounted on the electrode connector 1011' (or 1012') at one end of the wire, and the other end of the wire is provided with a plug connector 1016 and the thoracic impedance acquisition module 1013 and the heart rate acquisition module.
  • the plug port 109 of 1014 is connected.
  • the integrated lead wires connected to the wires 1011 (or 1012) and the wires are connected to the chest impedance acquisition module 1013 and the plug port 109 of the heart rate acquisition module 1014.
  • the acquisition front end of the click sound collection module 1015 is a microphone 1017, which is located on a surface of the device housing 107.
  • Embodiment 2 is a diagrammatic representation of Embodiment 1:
  • an embodiment of the present invention provides a monitoring system including the bio-impedance-based sleep breathing state signal collecting device described in the foregoing embodiment, and further includes wirelessly connecting with the signal collecting device 100.
  • the terminal processing device 200 includes a data analysis module 201, a real-time data display module 202, and a storage and playback module 203.
  • the data analysis module 201 is wirelessly connected to the received signal acquisition device 100, and configured to receive the collected digital data and perform matching analysis on the chest impedance data and the heart rate data in the collected digital data, and simultaneously use the click data as the sleep state reference data.
  • the real-time data display module 202 is coupled to the data analysis module 201 and displays chest impedance, heart rate, and click curve; the storage and playback module 203 and the real-time data
  • the display module 202 is connected and stores the collected data processing results to facilitate historical viewing.
  • the embodiment of the invention mainly utilizes the three-channel structure of the chest impedance acquisition module, the heart rate signal acquisition module and the click sound collection unit in the signal acquisition unit, and simultaneously separately collects the signal data of the respiratory impedance, the heart rate and the click sound, as shown in FIGS. 8 to 10 . Shown.
  • the monitoring system can be used not only as an OSAHS but also as an important reference for different OSAHS categories.

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Abstract

一种基于生物阻抗的睡眠呼吸状态信号采集设备（100）及监测系统，该信号采集设备（100）包括信号采集单元（101）、处理控制单元（102）、数据存储单元（103）和无线通讯单元（104），其中所述信号采集单元（101）包括与人体胸部接触的电极（1011, 1012）、与所述电极（1011, 1012）连接的胸阻抗采集模块（1013）、与所述电极（1011, 1012）连接的心率采集模块（1014）以及鼾声采集模块（1015）。因此，所述信号采集单元（101）通过三个通道单独同步同时采集信号数据，采用基于生物阻抗技术获取胸阻抗和心率信号并结合鼾声音频信号来监测睡眠呼吸状态，同时采用无线信号传输的方式避免了患者身上连接导线导致的不易入睡或睡眠程度浅、夜间易醒等问题，具有简单廉价、穿戴方便、适合家庭使用的优点。

Description

基于生物阻抗的睡眠呼吸状态信号采集设备及监测系统 技术领域
本发明属于生物医疗监测技术领域，尤其是涉及一种基于生物阻抗的睡眠呼吸状态信号采集设备及监测系统。
背景技术
生物阻抗技术是一种利用生物组织及器官的电特性提取人体生理与病理信息的无创检测技术。不同的人体组织与器官具有独特的生物阻抗特性，组织与器官的状态或功能变化也将伴随相应的生物阻抗特性改变。比如现有技术中有利用膈肌疲劳程度与胸部呼吸电阻抗信号及腹部呼吸电阻抗信号的波峰的同步程度有关的原理，将膈肌疲劳程度分为不同的类型。生物阻抗技术在临床医学方面有无创无损、便于长时间实时监护及低成本等优势，使得生物阻抗技术应用于临床医学或医疗保健领域具有很大的潜力与价值。
对于睡眠呼吸状态的监测直接关系到睡眠疾病的研究，因此睡眠呼吸监测成为睡眠医学中重点关注的话题。在睡眠疾病中，睡眠呼吸暂停是指睡眠中呼吸停止的睡眠障碍，具体为在连续7小时睡眠中发生30次以上的呼吸暂停，每次气流中止10s以上(含10s)，或平均每小时睡眠呼吸暂停低通气次数(呼吸紊乱指数)超过5次，而引起慢性低氧血症及高碳酸血症的临床综合征。它可分为中枢型、阻塞型及混合型。其中，阻塞性睡眠呼吸暂停(Obstructive sleep apnea-hypopnea syndrome,OSAHS)，是在睡眠中咽喉附近的软组织松弛而造成上呼吸道狭窄甚至阻塞从而呼吸暂停；中枢性睡眠呼吸暂停(Central sleep apnea-hypopnea syndrome,OSAHS)，是与控制呼吸的中枢神经系统功能失调有关，暂时失去呼吸功能的中枢神经驱动，这种呼吸障碍不是气道阻塞引起的，通常上气道无气流通过的时间>10s，无胸腹呼吸运动；以及上述两者的混合型。目前据统计，有呼吸睡眠障碍的人数占总人口的2％～4％，并且该数字有明显上 升的趋势。由各种原因导致睡眠中反复出现的呼吸暂停/低通气、高碳酸血症、睡眠中断，从而使机体发生一系列病理生理改变的临床综合症称为睡眠呼吸暂停低通气综合症(Sleep Apnea Hypopnea Syndrome，SAHS)。而对于上述睡眠呼吸障碍尽早合理的诊治，可提高患者的生活质量预防各种并发症的发生。因此，对睡眠呼吸的监测是预防和诊治睡眠呼吸障碍的首要步骤。
目前已有多种睡眠呼吸监测方法应用于临床。比如：多导睡眠图监测仪PSG，这是诊断睡眠呼吸暂停低通气综合征的金标准。它通过脑电图、眼动图和肌电图记录睡眠，并对睡眠进行分析，同时对病人的呼吸、肢体运动和血压进行监测。因此，PSG的问世对睡眠的研究具有决定意义。虽然基于PSG的睡眠呼吸检测技术能够准确地检测到呼吸的异常现象，但是由于这种检测手段需要患者佩戴面罩、胸腹带及较多电极，对患者有较大生理、心理负荷，容易产生“首夜效应”影响睡眠监测的结果；而且，仪器操作复杂，检测费用昂贵。目前专业的呼吸睡眠障碍诊断的机构不多，患者需要长时间的排队才能接受检查；患者在陌生环境，身上连接多根导线，不易入睡或睡眠程度浅，夜间易醒，从而使得实验失败或者实验结果偏差。另外，为了帮助医生提供诊断参考或制定治疗方案以及方便患者自己初步筛查等，对睡眠呼吸暂停患者来说，如何方便有效地监测睡眠呼吸状态成为一种新的市场需求。
发明内容
针对上述现有技术存在的不足，本发明的目的是提供一种适合个人或家庭初筛的简单易用的基于生物阻抗的睡眠呼吸状态信号采集设备。
为了实现上述目的，本发明所采用的技术方案如下：
一种基于生物阻抗的睡眠呼吸状态信号采集设备，包括：
信号采集单元，包括与人体胸部接触的电极、与所述电极连接的胸阻抗采集模块、与所述电极连接心率采集模块以及鼾声采集模块。
处理控制单元，分别与所述胸阻抗采集模块、心率采集模块以及鼾声采集模块连接，用于将所采集信号转换为数字信号且控制在正常或非正常情况下向 被测对象发出相应的提示或警示；
数据存储单元，与所述处理控制单元连接，用于存储处理控制单元转换得到的数字信号数据；
无线通讯单元，与所述数据存储单元连接，用于向外部终端无线传输数字信号数据；
在本发明一实施例中，所述信号采集设备还包括：
LED灯，与处理控制单元连接，用于显示所述信号采集设备的工作状态以及电源状态；
输出接口，与所述数据存储单元连接，用于有线向外输出采集数据；
设备外壳，用于容纳保护信号采集单元、处理控制单元、数据存储单元、无线通讯单元和供电单元；
插接端口，与所述胸阻抗采集模块和心率采集模块连接。
在本发明一实施例中，所述信号采集设备还包括固定夹，所述固定夹设置于设备外壳表面，用于固定人体处于睡眠呼吸状态下的信号采集设备。
在本发明一实施例中，所述信号采集设备还包括固定夹，所述固定夹设置于设备外壳表面，用于固定人体处于睡眠呼吸状态下的信号采集设备。
在本发明一实施例中，所述电极为激励电极或采集电极。
进一步地，所述输出接口和插接端口设置于所述设备外壳的同一侧表面。
在本发明一实施例中，所述电极安装于导线一端的电极接头上，导线另一端设有连接头与所述胸阻抗采集模块和心率采集模块的插接端口连接。
在本发明一实施例中，所述电极与导线相连成整体的一体化导联线与所述胸阻抗采集模块和心率采集模块的插接端口连接。
在本发明一实施例中，所述鼾声采集模块的采集前端为麦克风，该麦克风位于设备外壳的一表面。
在本发明一实施例中，当所述LED灯显示为红色时，表示信号采集设备处于电量不足状态，提示使用者充电或更换电池；当所述LED灯显示为绿色时， 表示信号采集设备电量充足且处于正常状态，提示使用者可以进行正常睡眠呼吸状态监测；当所述LED灯显示为黄色时，表示信号采集设备的电极与人体接触不良，提示使用者电极接触出现故障需诊断或重新调整电极与人体接触部位。
针对上述现有技术存在的不足，本发明的目的是提供一种适合个人或家庭初筛的简单易用的基于生物阻抗的睡眠呼吸状态信号采集设备。
为了实现上述目的，本发明又采用一种技术方案如下：
一种包含上述技术方案中所述的基于生物阻抗的睡眠呼吸状态信号采集设备的监测系统，还包括与所述信号采集设备无线连接的终端处理设备。
在本发明一实施例中，该终端处理设备包括：
数据分析模块，与接收信号采集设备无线连接，用于接收采集数字数据并将采集数字数据中的胸阻抗数据和心率数据进行匹配分析，同时利用鼾声数据作为睡眠状态参考数据；
实时数据显示模块，与所述数据分析模块相连并显示胸阻抗、心率和鼾声变化曲线；
存储与回放模块，与所述实时数据显示模块相连并将采集数据处理结果进行存储，以方便历史查看。
采用上述结构后，本发明和现有技术相比所包含的优点是：本技术方案采用基于生物阻抗技术获取胸阻抗和心率信号以及结合鼾声音频信号来监测睡眠呼吸状态，同时采用无线信号传输避免了患者身上连接导线所不易入睡或睡眠程度浅、夜间易醒等问题；该睡眠呼吸状态监测系统不仅简单廉价、方便穿戴、适合家庭使用，而且还不影响入睡，而且测试环境为日常真实睡眠环境，从而达到在不受睡眠姿态变化等动作的影响条件下对患者真实日常睡眠呼吸状态实时监测。
附图说明
下面结合附图和实施例对本发明进一步说明：
图1是本发明实施例一所述睡眠呼吸状态信号采集设备的结构框架示意图；
图2是本发明实施例一所述睡眠呼吸状态信号采集设备的主视图；
图3是本发明实施例一所述睡眠呼吸状态信号采集设备的侧视图；
图4是本发明实施例一所述睡眠呼吸状态信号采集设备的导联线的结构示意图；
图5是本发明实施例一所述睡眠呼吸状态信号采集设备(未插接导联线)的俯视图；
图6是本发明实施例二所述睡眠呼吸状态监测系统与人体连接关系示意图；
图7是本发明实施例二所述睡眠呼吸状态监测系统的结构框架示意图；
图8是本发明实施例二所述睡眠呼吸状态监测系统的胸阻抗(呼吸)变化曲线图；
图9是本发明实施例二所述睡眠呼吸状态监测系统的心率变化曲线图；
图10是本发明实施例二所述睡眠呼吸状态监测系统的鼾声分贝曲线图。
附图标记：
100-信号采集设备，101-信号采集单元，1011、1012-电极，1011′、1012′-电极接头，1013-胸阻抗采集模块，1014-心率采集模块，1015-鼾声采集模块，1016-插接头，1017-麦克风，102-处理控制单元，103-数据存储模块，104-无线通讯单元，105-LED灯，106-输出接口，107-设备外壳，108-固定夹，109-插接端口，200-终端处理设备，201-数据分析模块，202-实时数据显示模块，203-存储与回放模块。
具体实施方式
本发明以下实施例所述的睡眠呼吸状态信号采集设备及监测系统主要采用生物阻抗技术来获取睡眠呼吸监测信号，同时采集鼾声作为参考信号，从而用于进行人体睡眠状态下的呼吸暂停时间检测、睡眠呼吸暂停综合征的分类诊断以及睡眠质量评估，尤其适合于亚健康人群的自我监测。以下所述仅为本发明的较佳实施例，并不因此而限定本发明的保护范围。
实施例一：
如图1所示，本发明实施例提供了一种基于生物阻抗的睡眠呼吸状态信号采集设备100，包括信号采集单元101、处理控制单元102、数据存储单元103和无线通讯单元104。
其中，所述信号采集单元101包括至少与人体胸部接触的两个电极1011和1012、与所述电极1011或1012连接的胸阻抗采集模块1013、与所述电极1011或1012连接心率采集模块1014以及鼾声采集模块1015；在本发明实施例中，两个电极1011和1012均可为激励电极和采集电极，采用双电极同时激励同时采集的方式。所述处理控制单元102分别与所述胸阻抗采集模块1013、心率采集模块1014以及鼾声采集模块1015连接，用于将所采集信号转换为数字信号。所述数据存储单元103与所述处理控制单元102连接，用于存储处理控制单元转换得到的数字信号数据。所述无线通讯单元104与所述数据存储单元103连接，用于向外部终端无线传输数字信号数据。上述各单元均有电源单元(图图未示)供电，比如外接电源或内设电池等，为了便于开关机启动，可设置与电源单元连接的电源开关。
如图2和图3所示，所述信号采集设备100还包括LED灯105、输出接口106、设备外壳107和插接端口109。
其中，所述LED灯105与处理控制单元102连接，用于显示所述信号采集设备100的工作状态以及电源状态。当所述LED灯105显示为红色时，表示信号采集设备100处于电量不足状态，提示使用者充电或更换电池；当所述LED灯105显示为绿色时，表示信号采集设备100电量充足且处于正常状态，提示使用者可以进行正常睡眠呼吸状态监测；当所述LED灯105显示为黄色时，表示信号采集设备100的电极与人体接触不良，提示使用者电极接触出现故障需诊断或重新调整电极与人体接触部位。
另外，为了方便医生了解患者平时的睡眠状态，所述输出接口106与所述数据存储单元103连接，用于有线向外输出采集数据；而所述设备外壳107用于容纳保护信号采集单元101、处理控制单元102、数据存储单元103和无线通 讯单元104。在本发明实施例中，所述信号采集单元101、处理控制单元102、数据存储单元103和无线通讯单元104集成于电路板上；所述插接端口109与所述胸阻抗采集模块1013和心率采集模块1014连接。如图5所示，为了减少采集与充电存在的相互影响，在本发明实施例中，所述输出接口106和插接端口109设置于所述设备外壳107的同一侧表面。
如图2所示，在本发明实施例中，所述信号采集设备100还包括固定夹108，所述固定夹108设置于设备外壳107表面，用于固定人体处于睡眠呼吸状态下的信号采集设备100。
如图4所示，所述电极1011(或1012)安装于导线一端的电极接头1011′(或1012′)上，导线另一端设有插接头1016与所述胸阻抗采集模块1013和心率采集模块1014的插接端口109连接。除此之外，所述电极1011(或1012)与导线相连成整体的一体化导联线与所述胸阻抗采集模块1013和心率采集模块1014的插接端口109连接。所述鼾声采集模块1015的采集前端为麦克风1017，该麦克风1017位于设备外壳107的一表面。
实施例二：
如图6和图7所示，本发明实施例提供一种包括上述实施例中所述的基于生物阻抗的睡眠呼吸状态信号采集设备的监测系统，还包括与所述信号采集设备100无线连接的终端处理设备200。在本发明实施例中，该终端处理设备200包括数据分析模块201、实时数据显示模块202和存储与回放模块203。
其中，所述数据分析模块201与接收信号采集设备100无线连接，用于接收采集数字数据并将采集数字数据中的胸阻抗数据和心率数据进行匹配分析，同时利用鼾声数据作为睡眠状态参考数据且尤其作为呼吸暂停及低通气状态的参考依据；所述实时数据显示模块202与所述数据分析模块201相连并显示胸阻抗、心率和鼾声变化曲线；所述存储与回放模块203与所述实时数据显示模块202相连并将采集数据处理结果进行存储，以方便历史查看。
由于现有技术的采集方式为采用单电极模式从心电信号中提取呼吸信号， 而本发明实施例主要利用信号采集单元中的胸阻抗采集模块、心率信号采集模块和鼾声采集单元的三通道结构，分别单独同时同步采集呼吸阻抗、心率和鼾声的信号数据，如图8至10所示。该监测系统不仅能作为检测OSAHS，还可以区分不同的OSAHS类别的重要参考信息。
上述内容仅为本发明的较佳实施例，对于本领域的普通技术人员，依据本发明的思想，在具体实施方式及应用范围上均会有改变之处，本说明书内容不应理解为对本发明的限制。

Claims (12)

  1. 一种基于生物阻抗的睡眠呼吸状态信号采集设备，包括：
    信号采集单元，包括与人体胸部接触的电极、与所述电极连接的胸阻抗采集模块、与所述电极连接心电采集模块以及鼾声采集模块；
    处理控制单元，分别与所述胸阻抗采集模块、心电采集模块以及鼾声采集模块连接，用于将所采集信号转换为数字信号数据且控制在正常或非正常情况下向被测对象发出相应的提示或警示；
    数据存储单元，与所述处理控制单元连接，用于存储处理控制单元转换得到的数字信号数据；
    无线通讯单元，与所述数据存储单元连接，用于向外部终端无线传输数字信号数据。
  2. 根据权利要求1所述的基于生物阻抗的睡眠呼吸状态信号采集设备，其特征在于，所述信号采集设备还包括：
    LED灯，与处理控制单元连接，用于显示所述信号采集设备的工作状态以及电源状态；
    输出接口，与所述数据存储单元连接，用于有线向外输出采集数据；
    设备外壳，用于容纳保护信号采集单元、处理控制单元、数据存储单元、无线通讯单元和供电单元；
    插接端口，与所述胸阻抗采集模块和心电采集模块连接。
  3. 根据权利要求1所述的基于生物阻抗的睡眠呼吸状态信号采集设备，其特征在于，所述信号采集设备还包括固定夹，所述固定夹设置于设备外壳表面，用于固定人体处于睡眠呼吸状态下的信号采集设备。
  4. 根据权利要求2所述的基于生物阻抗的睡眠呼吸状态信号采集设备，其特征在于，所述信号采集设备还包括固定夹，所述固定夹设置于设备外壳表面，用于固定人体处于睡眠呼吸状态下的信号采集设备。
  5. 根据权利要求1所述的基于生物阻抗的睡眠呼吸状态信号采集设备，其特征在于，所述电极为激励电极或采集电极。
  6. 根据权利要求2所述的基于生物阻抗的睡眠呼吸状态信号采集设备，其特征在于，所述输出接口和插接端口设置于所述设备外壳的同一侧表面。
  7. 根据权利要求1所述的基于生物阻抗的睡眠呼吸状态信号采集设备，其特征在于，所述电极安装于导线一端的电极接头上，导线另一端设有插接头与所述胸阻抗采集模块和心电采集模块的插接端口连接。
  8. 根据权利要求1所述的基于生物阻抗的睡眠呼吸状态信号采集设备，其特征在于，所述电极与导线相连成整体的一体化导联线与所述胸阻抗采集模块和心电采集模块的插接端口连接。
  9. 根据权利要求1所述的基于生物阻抗的睡眠呼吸状态信号采集设备，其特征在于，所述鼾声采集模块的采集前端为麦克风，该麦克风位于设备外壳的一表面。
  10. 根据权利要求2所述的基于生物阻抗的睡眠呼吸状态信号采集设备，其特征在于，当所述LED灯显示为红色时，表示信号采集设备处于电量不足状态，提示使用者充电或更换电池；当所述LED灯显示为绿色时，表示信号采集设备电量充足且处于正常状态，提示使用者可以进行正常睡眠呼吸状态监测；当所述LED灯显示为黄色时，表示信号采集设备的电极与人体接触不良，提示使用者电极接触出现故障需诊断或重新调整电极与人体接触部位。
  11. 一种包含权利要求1至10中任意一项所述的基于生物阻抗的睡眠呼吸状态信号采集设备的监测系统，还包括与所述信号采集设备无线连接的终端处理设备。
  12. 根据权利要求11所述的基于生物阻抗的睡眠呼吸状态监测系统，其特征在于，该终端处理设备包括：
    数据分析模块，与接收信号采集设备无线连接，用于接收采集数字数据并将采集数字数据中的胸阻抗数据和心率数据进行匹配分析，同时利用鼾声数据 作为睡眠状态参考数据；
    实时数据显示模块，与所述数据分析模块相连并显示胸阻抗、心率和鼾声变化曲线；
    存储与回放模块，与所述实时数据显示模块相连并将采集数据处理结果进行存储，以方便历史查看。
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