CN111657952B

CN111657952B - Intranasal internal cavity implanted sleep respiration monitoring and blocking positioning system

Info

Publication number: CN111657952B
Application number: CN202010672649.3A
Authority: CN
Inventors: 张绍兴; 李儒雅; 刘俊秀; 王雅馨
Original assignee: Beihang University; Peking University Third Hospital Peking University Third Clinical Medical College
Current assignee: Beihang University; Peking University Third Hospital Peking University Third Clinical Medical College
Priority date: 2020-07-14
Filing date: 2020-07-14
Publication date: 2022-12-09
Anticipated expiration: 2040-07-14
Also published as: CN111657952A

Abstract

The invention provides a nasal cavity internal cavity implanted sleep respiration monitoring and obstruction positioning system, which comprises a sensing module, an acquisition module and a processing module, wherein the sensing module comprises a carrier catheter integrated with a pressure sensor array and can monitor contact pressure signals in a respiratory tract, the acquisition module can acquire and transmit the pressure signals, and the processing module can process and analyze the pressure signals so as to acquire the pressure change condition in the respiratory tract and store and display the pressure signals. This system can put into hypopharynx portion through the nostril, has good fixed and human tolerance, and the contact pressure at each position of respiratory track can be monitored to its flexible pressure sensor to the different physiological state of upper respiratory track when real-time, accurate acquisition sleep both can directly reflect the sleep respiratory track jam condition, also can judge specific jam plane, the formulation of assistance operation scheme, improvement treatment.

Description

Intranasal internal cavity implanted sleep respiration monitoring and blocking positioning system

Technical Field

The invention relates to the field of medical instruments, in particular to an implanted sleep respiration monitoring and obstruction positioning system through an internal cavity of a nose.

Background

The upper respiratory tract of a patient with Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS) is partially or completely blocked during sleeping, so that apnea or hypopnea is caused, frequent blood oxygen saturation is reduced, sleep structural disorder is caused, and further multiple organ tissues such as blood vessels, heart, brain and the like are damaged.

The "golden standard" tool currently and generally used in clinical diagnosis of OSAHS is the Polysomnography (PSG), and portable sleep monitors have also begun to be used in recent years. The above system allows for overall monitoring and diagnosis of apnea, hypopnea and hypoxemia, i.e. macroscopically assessing the severity of the obstruction and obstruction, but has two disadvantages: one is the indirection of the evaluation. PSG indirectly reflects the obstruction and low ventilation change of a respiratory channel through the obtained air flow thoracic motion outside the mouth and the nose, and cannot directly reflect the most important pathological change of a specific pathogenic link in the pathogenic process of the disease, namely the specific collapse and blockage change of an upper respiratory tract. Secondly, PSG can only qualitatively and quantitatively determine the upper respiratory tract macroscopically, and cannot determine a specific occlusion plane, i.e., cannot accurately analyze, monitor and diagnose specific occlusion sites and the degree of occlusion at each occlusion site.

The method for removing the blockage of the anatomical part through the surgical operation is one of important ways for treating the OSAHS, and the accurate obtaining of the information of the blocked part before the operation and the accurate operation of the blocked area are the keys for improving the curative effect, so that the method has important clinical significance for the blockage positioning diagnosis of the OSAHS patient. Currently available sleep apnea obstruction localization systems are apneagraph and flextube. The principle of the apneagraph is that the air pressure sensor is used for collecting the air pressure at different positions of a breathing passage and calculating the difference of the air pressure to perform blocking positioning; flextube is somewhat more complex, and sound transmission is affected by sound conduction in a duct at different pressures, and the pressure changes around the duct are obtained by indirectly measuring the sound transmission changes to locate the breathing obstruction. However, the existing occlusion positioning system still has the technical problems of complex structure, poor tolerance of human body, incapability of directly positioning and inaccurate positioning.

Disclosure of Invention

Aiming at the problems in the prior art, the invention provides a nasal cavity built-in type sleep respiration monitoring and obstruction positioning system, which can be placed in the hypopharynx through a nasal hole and has good fixation and human body tolerance, and a flexible pressure sensor can monitor the contact pressure generated when an object contacts with the sensor, so that different physiological states of an upper respiratory tract of an OSAHS patient during sleep, such as the pressure level and the pressure change mode during unobstructed, blocked and open accompanying snoring, can be accurately obtained in real time, the obstruction condition of the sleep respiratory tract can be directly reflected, a specific obstruction plane can be judged, the formulation of an operation scheme is assisted, and the treatment effect is improved.

The technical scheme of the invention is as follows:

an implanted sleep respiration monitoring and obstruction positioning system through a nasal cavity and an internal cavity comprises a sensing module, an acquisition module and a processing module;

the sensing module includes a carrier catheter integrated with an array of pressure sensors configured to monitor contact pressure signals within the respiratory tract;

the acquisition module comprises an acquisition circuit, and is configured to acquire and transmit the pressure signal;

the processing module comprises a data storage and analysis unit and a user interface, and is configured to process and analyze the pressure signal so as to obtain sleep respiration monitoring and obstruction positioning information, and store and interact with a user, such as display, printing and the like.

The carrier catheter of the sensing module is placed in the pharynx through the nasal cavity, and the upper respiratory tract lumen mucosa contact pressure is directly contacted and collected through the pressure sensor array. The length and the pipe diameter of the carrier catheter are matched with the human anatomy structure and can be divided into a nasal cavity traction fixing part and a pharyngeal cavity sensor array part, the diameter of the nasal cavity traction fixing part is smaller than that of the pharyngeal cavity sensor array part, the diameter of the lower portion of the pharyngeal cavity sensor array part, which is connected with the entrance of the esophagus, is gradually reduced, and each pressure sensor is distributed on the pharyngeal cavity sensor array part, so that pressure signals of corresponding portions of the upper respiratory tract are obtained. The carrier catheter is made of soft material and moderate flexibility, and can be made of non-toxic medical high polymer materials such as silica gel, TPE, PP or PTFE, and the carrier catheter can be internally provided with a supporting guide wire to prevent the sensor array and the carrier catheter from being folded and bent.

Wherein the pressure sensor array is attached to the surface of the carrier conduit and comprises a plurality of thin film flexible pressure sensors, and the flexible pressure sensors can monitor the contact pressure generated when an object contacts the sensors. Each sensor can independently collect pressure signals at the sensor, and the sensor lead is connected to the terminal interface from the inside of the carrier conduit and is connected with the collection circuit. Specifically, the pressure sensor array comprises three groups of sensors corresponding to the palatopharyngeal, oropharyngeal and hypopharynx sections, each group comprising a plurality of thin film flexible pressure sensors.

The processing module can record respiratory tract collapse obstruction conditions and sleep respiratory events at different moments, so that the times of sleep apnea and hypopnea in each hour can be calculated, and the function of monitoring sleep respiration is achieved. The processing module can also judge whether the air passage at the position of the sensor is blocked or not by comparing the pressure signals of the sensors, namely, the processing module has the function of blocking and positioning. And the processing module can display the monitored pressure signal and the airway obstruction condition obtained by analysis through a user display interface.

Furthermore, the nasal cavity implanted sleep respiration monitoring and obstruction positioning system has expansion and integration functions. For example, on the basis of the existing system, auxiliary parameter collecting devices such as heart rate, electrocardiogram, blood oxygen saturation, electroencephalogram, electro-oculogram, body position change, external snore monitoring, thoracoabdominal movement monitoring and the like can be added, the monitoring range is expanded, pressure signals and auxiliary parameters are comprehensively processed, and the accuracy of blocking positioning is further improved. Furthermore, the system may also be integrated into existing PSG diagnostic systems.

The invention also provides a sleep respiration monitoring and obstruction positioning method based on the pressure sensor, which comprises the following steps: monitoring pressure signals within the respiratory tract, including one or more pressure signals within the respiratory tract; denoising the pressure signal; analyzing the pressure signal to obtain upper respiratory tract obstruction information; and processing, storing and displaying the blockage information based on specific service logic to finally obtain a sleep respiration monitoring report and blockage positioning information.

Compared with the prior art, the nasal cavity implanted sleep respiration monitoring and blocking positioning system has the advantages that: the invention directly monitors the pressure signal of the upper respiratory tract by the flexible pressure sensor array, has the advantages of light weight, easy carrying, easy fixation, good human body tolerance, wide application in the respiratory monitoring in the sleeping process and accurate positioning of the blocked position.

Drawings

The accompanying drawings, which are included to provide a further understanding of the invention and are incorporated in and constitute a part of this specification, illustrate embodiments of the invention and together with the description serve to explain the principles of the invention and not to limit the invention. In the drawings:

FIG. 1 is a schematic diagram of an embodiment of a respiratory tract-embedded sleep respiration monitoring and occlusion locating system according to the present invention;

FIG. 2 is a schematic diagram of the components of an airway-embedded sleep apnea monitoring and occlusion locating system in accordance with an embodiment of the present invention;

fig. 3 is a schematic diagram illustrating the use of an airway-embedded sleep respiration monitoring and occlusion locating system in an embodiment of the present invention.

In the figure: 1. a carrier conduit; 2. a thin film flexible pressure sensor; 3. an acquisition module; 4. a processing module; 11. a nasal traction fixation portion; 12. pharyngeal sensor array portion.

Detailed Description

The preferred embodiments of the present invention will be described in conjunction with the accompanying drawings, and it should be understood that they are presented herein only to illustrate and explain the present invention and not to limit the present invention.

An implantable sleep respiration monitoring and occlusion positioning system via the nasal cavity is shown in fig. 1 and comprises a sensing module, an acquisition module 3 and a processing module 4.

The sensing module comprises a carrier catheter 1 integrated with a pressure sensor array, the carrier catheter 1 is made of medical high polymer materials, the cross section of the carrier catheter is circular, and the carrier catheter can be specifically divided into a nasal cavity traction fixing part 11 and a pharyngeal cavity sensor array part 12. The carrier catheter 1 is internally provided with a guide wire, so that the carrier catheter 1 can be prevented from being folded and curled when snoring and swallowing.

According to the anatomical characteristics of a human body, the nasal cavity traction fixing part 11 is 7.5cm long and about 1.5mm in diameter, is mainly used for guiding from the nasal cavity and fixing the carrier catheter 1 from the nasal surface, and is not provided with a sensor as shown in fig. 3, so that the stimulation to the nasal cavity feeling can be reduced, and the interference to the nasal cavity ventilation function can be reduced; pharyngeal sensor array portion 12 is 12cm long and about 3mm in diameter, and about 1.5cm in diameter below the esophageal entrance, with the pharyngeal sensor array portion having an array of pressure sensors.

The pressure sensor array comprises a plurality of film type flexible pressure sensors 2, the sensors are arranged according to the characteristics of the local anatomical structure of a human body, and the pressure sensor array specifically comprises the following components: 3 groups of sensors are intensively arranged at the palatopharynx, the oropharynx and the hypopharynx (which respectively correspond to three common anatomical structures of a soft palate area of the nasopharynx, a tonsillar area and an epiglottis area which are most common in clinic), each group is provided with a plurality of sensor units, and each sensor group is provided with 2 sensor units in the example, and the total number of the sensors is 6. The sensors are uniformly and discontinuously arranged, the total number of the sensors is 6, each sensor is 1cm long and 1cm apart, and the whole pharyngeal portion can be monitored. The pressure change during contact can be directly sensed by contacting with mucosa of nasopharynx, oropharynx and hypopharynx.

When the soft tissues of the respiratory tract collapse to cause the local blockage of the tube cavity, the soft tissues are mutually contacted and extruded, and the pressure P1 is monitored by the sensor; if breathing movement still exists at the moment, negative pressure is generated at the lower end of the obstruction, additional suction is generated on the collapsed mucosa at the obstruction part by the formation of the negative pressure, and the contact pressure of the mucosa is increased to be P2; the method comprises the following steps that arousal occurs due to oxygen deficiency, an airway is reopened, pressure is instantly decreased or even disappears, a large amount of airflow is inhaled from the outside after the airway is randomly opened, when the airflow impacts at a high speed, mucosa vibrates, contact pressure is generated by the mucosa in a vibration state on a sensor in contact with the mucosa, and rhythm change waveforms are generated by the pressure along with vibration frequency and are called as P3 waves; if snoring continues later, the continuous P3 wave can be detected, if normal breathing is recovered, the stable and smooth breathing is realized, because the mucosa is not collapsed and squeezed at the moment, the pressure is at a baseline level P0. The single sensor can obtain the pressure value and the change of a single anatomical part, and the combination of the plurality of sensors can enable a doctor to obtain the pressure magnitude, the change frequency and the change amplitude of different anatomical positions, so as to obtain the obstruction degree, the obstruction duration and the mucosa vibration position (snore source) of different positions. The mode of monitoring through multiple points of pressure not only provides direct respiratory tract obstruction diagnosis, but also simultaneously judges the obstruction plane to be solved by the operation, and provides important evaluation basis for the next operation.

The processing module 4 is used for processing and analyzing the pressure signal, so as to obtain the pressure change condition in the respiratory tract, and storing and displaying the signal. As shown in fig. 2, the processing module 4 includes a data storage and analysis unit and a user interface, the data storage and analysis unit can obtain a specific analysis result, i.e. an evaluation report, from the pressure monitoring data by analyzing and evaluating algorithms, including total respiratory obstruction times, average obstruction times per hour, respiratory obstruction times of each part, average obstruction times per hour, and obstruction ratios of different parts, and output the result through the user interface. The processing module 4 may also display the pressure changes at different points of the sensor array in real time via the virtual anatomical map on the user interface.

In a specific embodiment, the system is further provided with auxiliary parameter collecting devices such as heart rate, electrocardiogram, blood oxygen saturation, electroencephalogram, electro-oculogram, body position change, external snore monitoring, thoracoabdominal movement monitoring and the like, and the auxiliary parameters are combined with the pressure parameters collected by the system, so that the monitoring and positioning accuracy can be further improved.

The invention also provides a sleep respiration monitoring and obstruction positioning method based on the system, which comprises the following steps: monitoring pressure signals within the respiratory tract, including one or more pressure signals within the respiratory tract; denoising the pressure signal; analyzing the plurality of pressure signals to obtain upper respiratory tract obstruction information; and processing the plurality of upper respiratory tract obstruction information to obtain a sleep respiration monitoring report and obstruction positioning information, storing and outputting the monitoring report and the obstruction positioning information through a user interface.

It will be apparent to those skilled in the art that various changes and modifications may be made in the present invention without departing from the spirit and scope of the invention. Thus, if such modifications and variations of the present invention fall within the scope of the claims of the present invention and their equivalents, the present invention is also intended to include such modifications and variations.

Claims

1. The utility model provides an it monitors and blocks positioning system to put into formula sleep breathing through intranasal coelomic canal which characterized in that includes: a sensing module, an acquisition module and a processing module,

the sensing module comprises a carrier catheter integrated with a pressure sensor array for monitoring contact pressure signals in the respiratory tract;

the carrier catheter is arranged at the pharyngeal portion through the nasal cavity, and directly contacts and collects the mucosa contact pressure of the upper respiratory tract lumen through the pressure sensor array; the carrier catheter comprises a nasal cavity traction fixing part and a pharyngeal cavity sensor array part, and the pharyngeal cavity sensor array part is provided with a pressure sensor array; the carrier catheter is internally provided with the guide wire, so that the carrier catheter can be prevented from being folded and curled when snoring and swallowing;

the carrier catheter is made of medical polymer materials, the cross section of the carrier catheter is circular, the diameter of the nasal cavity traction fixing part is smaller than that of the pharyngeal cavity sensor array part, and the diameter of the lower part of the pharyngeal cavity sensor array part, which is connected with the entrance of the esophagus, is gradually reduced;

the pressure sensor array comprises a plurality of film type flexible pressure sensors, each sensor can independently collect pressure signals at the sensor, and a sensor lead is connected to the tail end interface from the inside of the carrier conduit and is connected with the collection circuit;

the pressure sensor array is arranged according to the characteristics of the local anatomical structure of the human body, and specifically comprises the following steps: 3 groups of sensors are intensively arranged at the palatopharyngeal, oropharyngeal and hypopharynx parts, each group is provided with a plurality of sensor units, and the sensors are uniformly and discontinuously arranged; the palatopharynx, the oropharynx and the hypopharynx respectively correspond to three common anatomical structures of a soft palate region, a tonsil region and a tongue root epiglottis region of the nasopharynx, the tonsil region and the tongue root epiglottis region which are most common in clinic;

the detection process of the sensor is as follows: when the soft tissues of the respiratory tract collapse to cause the local blockage of the tube cavity, the soft tissues are mutually contacted and extruded, and the sensor monitors the pressure P1; if breathing movement still exists at the moment, negative pressure is generated at the lower end of the obstruction, additional suction is generated on the collapsed mucosa at the obstruction part by the formation of the negative pressure, and the contact pressure of the mucosa is increased to be P2; the method is characterized in that the arousal is caused due to oxygen deficiency, the air passage is reopened, the pressure is instantly decreased or even disappeared, a large amount of air flow is inhaled from the outside after the air passage is opened randomly, when the air flow impacts at a high speed, the mucosa vibrates, the mucosa in a vibration state generates contact pressure to a sensor in contact with the mucosa, and the pressure generates a rhythm change waveform along with the vibration frequency, which is called as P3 wave; if snoring continues later, detecting continuous P3 waves, and if normal breathing is recovered, namely stable and smooth breathing, because the mucosa is not collapsed and extruded at the moment, the pressure is at a baseline level P0;

the pressure value and the change of a single anatomical part can be obtained through a single sensor, and the combination of a plurality of sensors can enable a doctor to obtain the pressure magnitude, the change frequency and the change amplitude of different anatomical positions, so that the obstruction degree, the obstruction duration and the mucosa vibration position of different positions can be obtained; direct respiratory tract obstruction diagnosis can be provided by a multipoint pressure monitoring mode, and meanwhile, an obstruction plane to be solved in an operation is judged, so that an evaluation basis is provided for the next operation;

the acquisition module comprises an acquisition circuit and is used for acquiring and transmitting the pressure signal;

the processing module comprises a data storage and analysis unit and a user interface, and is used for analyzing and processing the pressure signal so as to obtain sleep respiration monitoring data and obstruction positioning information, storing the information and carrying out user interaction; the data storage and analysis unit can obtain a specific analysis result, namely an evaluation report, from the pressure monitoring data through an analysis and evaluation algorithm, wherein the evaluation report comprises the total respiratory obstruction times, the average obstruction times per hour, the respiratory obstruction times of each part, the average obstruction times per hour and the obstruction ratio of different parts, and is output through a user interface;

the processing module can display the pressure change of different positions of the sensor array in real time through the virtual anatomic structure diagram on the user interface;

the system further comprises an auxiliary parameter collecting device, and the processing module can comprehensively process the pressure signal and the auxiliary parameter to perform sleep breathing detection and obstruction positioning;

the auxiliary parameter collecting device comprises one or more of heart rate, electrocardiogram, blood oxygen saturation, electroencephalogram, electro-oculogram, posture change, external snore monitoring and chest and abdomen movement monitoring devices.

2. A method of utilizing the sleep respiration monitoring and occlusion locating system of claim 1, comprising the steps of:

monitoring a pressure signal at one or more locations within the respiratory tract via a pressure sensor;

denoising the pressure signal;

analyzing and processing the de-noised pressure signal to obtain upper respiratory tract obstruction information;

processing the upper respiratory tract obstruction information to obtain sleep respiration monitoring data and obstruction positioning information;

outputting the sleep respiration monitoring data and occlusion locating information through a user interface.