Split type mask, respiration monitoring system and using method of respiration monitoring system

Abstract

The split type mask, the breath monitoring system and the using method of the breath monitoring system are provided, the split type mask is suitable for endoscopy, the split type mask comprises a nose mask body, a mouth mask body and a connecting piece, and the nose mask body and the mouth mask body are connected through the connecting piece. An oxygen uptake tube connector is formed in the nose cover body and used for being connected with an external oxygen supply device so as to supply oxygen into the nose cover body. An endoscopic examination opening is formed in the mouth cover body, and endoscopic examination instruments such as a gastroscope can pass through the endoscopic examination opening. The nasal mask body further comprises a nasal pressure sensor and a nasal aspirator connector which are respectively used for monitoring pressure in the nasal mask body and sucking aerosol in the nasal mask body, and / or the mouth mask body further comprises a mouth pressure sensor and a mouth aspirator connector which are respectively used for monitoring pressure in the nasal mask body and sucking aerosol in the nasal mask body. The nose mask body and the mouth mask body are respectively used for monitoring pressure in the mouth mask body and sucking aerosol in the mouth mask body, and the nose mask body and the mouth mask body are respectively attached to the face of a wearer and are not communicated with each other.

Description

Technical Field

[0001] The present application relates to the field of medical device technology, and in particular to a split mask, a respiratory monitoring system and a method of using the same. Background Art

[0002] Digestive tract diseases are common diseases in internal medicine, and their diagnosis and treatment process often requires the use of gastroscopy to examine the patient's digestive tract. Traditional gastroscopy examinations take a long time and are painful, and patients have a poor experience. Painless gastroscopy technology has the advantages of high clarity, high resolution, high diagnostic rate, no blind spots for examination, and is not prone to digestive tract damage. Its application in clinical examinations is becoming more and more common.

[0003] In the prior art, the masks used for painless gastroscopy are mostly one-piece masks that fully cover the nose and mouth, and are provided with an inspection hole at the oral cavity for the gastroscope tube to pass through. If the sealing between the inspection hole of the one-piece mask and the gastroscope tube is too high, it may cause excessive air pressure inside the mask, affect the doctor's operation of the gastroscope tube, make it difficult to remove the gastroscope tube, reduce the accuracy of gastroscopy, etc. However, if a larger gap is formed between the inspection hole of the one-piece mask and the gastroscope tube to facilitate the extension and withdrawal of the gastroscope tube, the patient's oxygen concentration may be uncontrollable due to insufficient sealing of the mask, making it difficult to meet the patient's high-flow oxygen supply needs in critical situations, which poses certain safety hazards.

[0004] When patients undergo painless gastroscopy, they usually need intravenous anesthesia and oxygen inhalation through a mask. Anesthetic drugs may inhibit the patient's breathing, causing the patient's breathing to slow down and become shallow, and the respiratory rhythm to be unstable, and may even cause a few patients to experience symptoms such as apnea, severe hypoxemia, and suffocation. At the same time, painless gastroscopy is also a typical medical operation that is prone to high-intensity droplets / aerosols. Droplets / aerosols are the main transmission medium for respiratory infectious diseases and have the risk of causing infection to medical staff and patients. When patients undergo painless digestive endoscopy, hiccups, snoring, coughing and other involuntary high-intensity breathing behaviors often occur, which may release aerosols / droplets with high concentrations of viruses. Especially for older patients (over 55 years old), obese patients, patients with short thyromental distance, high Mallampati grade, and patients who may have difficulty in mask ventilation, they are more likely to have high-intensity breathing behaviors such as snoring after anesthesia due to the back drop of the tongue root and the collapse of the pharyngeal soft tissue. If the one-piece mask does not seal well enough, medical staff may be exposed continuously for a long time; if the one-piece mask seals too tightly, viral droplets may accumulate in the mask for a long time, and inevitably release high-concentration viral aerosols during the extubation process, which may cause medical staff to be directly exposed at close range (usually within 1 meter) instantly.

[0005] Existing endoscopic examinations have improved the oxygen supply problem of the one-piece mask that fully covers the nose and mouth used in endoscopic examinations, but have not considered and solved the problems of patient respiratory monitoring and aerosol transmission control. Summary of the invention

[0006] This application is made in view of the above-mentioned state of the prior art. The purpose of this application is to provide a split mask to improve the contradiction between the convenience of operation and the oxygen supply demand of the traditional one-piece mask when applied to endoscopic examination.

[0007] The present application also provides a respiratory monitoring system including the above-mentioned split mask and a method of using the system to monitor the patient's respiratory condition and high-intensity breathing behavior, and an external suction device can be used to absorb the aerosol in the mask.

[0008] The present application provides a split mask suitable for endoscopic examination, wherein the split mask comprises a nasal mask body, an oral mask body and a connector, wherein the nasal mask body and the oral mask body are connected via the connector.

[0009] The nose mask body is formed with an oxygen inhalation tube interface for connecting an external oxygen supply device to supply oxygen to the nose mask body; the mouth mask body is formed with an endoscopic inspection port for passing endoscopic inspection equipment such as a gastroscope,

[0010] The nasal mask body further comprises a nasal pressure sensor and a nasal aspirator interface, which are respectively used to monitor the pressure inside the nasal mask body and to suck the aerosol inside the nasal mask body, and / or the oral mask body further comprises an oral pressure sensor and an oral aspirator interface, which are respectively used to monitor the pressure inside the oral mask body and to suck the aerosol inside the oral mask body,

[0011] The nasal mask and the oral mask are used to fit the wearer's face respectively without being connected to each other.

[0012] In at least one possible embodiment, the oral mask further includes an inspection port accessory, wherein the inspection port accessory is connected to the endoscopic inspection port.

[0013] The connection mode between the inspection port accessory and the endoscope inspection port is one of a snap-on slot connection, a threaded connection, and a magnetic connection.

[0014] In at least one possible implementation, the inspection port accessory is a first inspection port accessory, and the first inspection port accessory is a double-layered conical structure.

[0015] The outer top of the first inspection port accessory forms a flap structure, and the flap structure includes a plurality of adjacent flaps for scraping liquid off the wall of the endoscope tube.

[0016] The inner bottom of the first inspection port accessory forms a collecting groove, and the collecting groove is formed between the double layers of material of the first inspection port accessory and is used to collect liquid.

[0017] In at least one possible implementation, the inspection port accessory is a second inspection port accessory, and the second inspection port accessory is hourglass-shaped.

[0018] The inner diameter of the second inspection port accessory gradually decreases from the inside to the outside, and the outer diameter of the second inspection port accessory gradually increases from the inside to the outside.

[0019] A filter is provided inside the middle of the second inspection port accessory to prevent liquid from flowing back or splashing.

[0020] In at least one possible embodiment, the nasal mask body is also formed with a carbon dioxide monitoring interface for connecting an external carbon dioxide monitoring device.

[0021] In at least one possible implementation, the nasal pressure sensor and / or oral pressure sensor is a flexible film pressure sensor.

[0022] In at least one possible embodiment, the nasal mask body further includes two nasal wearing connection parts, a nasal seal and a nasal elastic band, wherein the two nasal wearing connection parts are respectively arranged on both sides of the bottom of the nasal mask body, and the two nasal wearing connection parts are respectively connected to the two ends of the nasal elastic band;

[0023] and / or

[0024] The oral mask body also includes two oral wearing connecting parts, an oral sealing member and an oral elastic band. The two oral wearing connecting parts are respectively arranged on both sides of the middle part of the oral mask body, and the two oral wearing connecting parts are respectively connected to the two ends of the oral elastic band.

[0025] The present application also provides a respiratory monitoring system, which includes the aforementioned split mask, an external suction device and a monitoring controller.

[0026] The nasal suction interface is connected to the external suction device, the nasal pressure sensor is connected to the monitoring controller, and / or the oral suction interface is connected to the external suction device, the oral pressure sensor is connected to the monitoring controller.

[0027] In at least one possible embodiment, the external suction device includes an electric pump and a waste liquid container, and the monitoring controller is connected to the electric pump to control the operation of the electric pump.

[0028] The nasal suction device interface and / or the oral suction device interface are connected to the waste liquid container via a hose to collect aerosols and liquids; and / or the monitoring controller includes a circuit control module and a liquid crystal display module,

[0029] The circuit control module is connected to the external suction device to control the operation of the external suction device.

[0030] The liquid crystal display module can display the pressure curve monitored by the nasal pressure sensor and / or oral pressure sensor.

[0031] The present application also provides a method for using a respiratory monitoring system, which is applicable to the above-mentioned respiratory monitoring system, wherein the split mask includes a first inspection port accessory or a second inspection port accessory;

[0032] The method of use includes:

[0033] Assess the patient's condition and select to use the first inspection port accessory or the second inspection port accessory according to the patient's condition;

[0034] Wearing the nasal mask and the oral mask, wherein the nasal mask fits tightly against the patient's head;

[0035] Connecting the nasal mask and the oral mask to other equipment;

[0036] Perform an endoscopic examination while monitoring the patient's condition; the external suction device sucks the aerosol in the nasal mask and / or the oral mask according to the pressure value monitored by the monitoring controller.

[0037] The split mask provided by the present application can facilitate endoscopic examination without affecting the patient's high-flow oxygen inhalation by designing the nasal mask body and the oral mask body separately. The respiratory monitoring system and its use method provided by the present application can monitor the patient's respiratory condition, especially the patient's high-intensity breathing behavior, and use an external suction device to absorb the aerosol in the mask to reduce the risk of aerosol infection for medical staff. BRIEF DESCRIPTION OF THE DRAWINGS

[0038] Figure 1 It is a schematic structural diagram of a respiratory monitoring system according to one embodiment of the present application.

[0039] Figure 2 It is a schematic structural diagram of a split-type mask according to one embodiment of the present application.

[0040] Figure 3 It is a schematic diagram of the inner structure of a split mask according to an embodiment of the present application.

[0041] Figure 4It is a schematic structural diagram of a nasal mask body according to one embodiment of the present application.

[0042] Figure 5 It is a schematic diagram of the structure of an oral mask body according to one embodiment of the present application.

[0043] Figure 6 It is a schematic diagram of the internal structure of the first inspection port accessory according to one embodiment of the present application.

[0044] Figure 7 It is a schematic structural diagram of another split-type mask according to an embodiment of the present application.

[0045] Figure 8 It is a schematic structural diagram of a second inspection port accessory according to one embodiment of the present application.

[0046] Fig. 9 It is a schematic structural diagram of an external suction device according to one embodiment of the present application.

[0047] Fig.10 The present invention is a flow chart of a method for using a respiratory monitoring system according to one embodiment of the present application.

[0048] Description of Reference Numerals

[0049] 100 Split Mask

[0050] 110 Nasal mask

[0051] 111 Oxygen tube interface

[0052] 112 Carbon dioxide monitoring interface

[0053] 113 Nasal Pressure Sensor

[0054] 114 Nasal suction port

[0055] 115 Nose wearing connection

[0056] 116 Nose seal

[0057] 120 Mouth mask

[0058] 121 Endoscopic examination port

[0059] 122 Oral pressure sensor

[0060] 123 Oral Suction Device Interface

[0061] 124 Mouth-mounted connector

[0062] 125 Mouth seal

[0063] 126 First inspection port accessories

[0064] 1261 Valve Structure

[0065] 1262 Collection Tank

[0066] 127 Second inspection port accessories

[0067] 1271 Filters

[0068] 130 Connectors

[0069] 200 External suction device

[0070] 210 Waste container

[0071] 211 Check valve

[0072] 220 Hose

[0073] 300 Monitoring Controller DETAILED DESCRIPTION

[0074] The exemplary embodiments of the present application are described below with reference to the accompanying drawings. It should be understood that these specific descriptions are only used to teach those skilled in the art how to implement the present application, and are not intended to exhaust all possible methods of the present application, nor to limit the scope of the present application.

[0075] The embodiment of the present application provides a split mask for endoscopic examination (such as gastroscopy, etc.), such as Figure 2 and Figure 3 As shown, the split mask 100 may include a nasal mask 110 and an oral mask 120, which may be connected via a connector 130. The nasal mask 110 and the oral mask 120 may be used to fit the wearer's face respectively without being connected to each other, so that the nasal mask 110 and the oral mask 120 can work relatively independently without affecting each other.

[0076] The connector 130 may be a flexible connecting belt, a slot connection, a snap connection, a magnetic connection, or other connection forms. The flexible connecting belt may be a flexible, elastic material such as a cloth material or a rubber material. The slot connection may be designed with a slot interface on the nasal mask 110 or the oral mask 120. The snap connection may be designed with a buckle at the bottom of the nasal mask 110 and a clip at the top of the oral mask 120. The buckle and the clip may be made of the same material as the nasal mask and the oral mask and may be integrally formed. The magnetic connection may be designed with a coaxial male end component and a female end component at the connection portion between the nasal mask 110 and the oral mask 120. Exemplarily, the shape of the male end component and the female end component may be a circle with a diameter less than 5 mm, and the number may be 1-2. The male end component and the female end may be embedded in the surface of the nasal mask or the oral mask, and the male end component and the female end component may be wrapped with an insulating colloid. It can be understood that connecting the nasal mask 110 and the oral mask 120 using a connector 130 with a flexible, slotted, snap-fit, magnetic or other structure can facilitate the patient to wear the nasal mask 110 and the oral mask 120 at the same time when wearing the mask, and can also adjust the wearing position of the nasal mask 110 and the oral mask 120 according to the patient's facial features (the distance between the mouth and the nose, etc.).

[0077] In order to facilitate the description of the specific technical solutions of this embodiment, unless otherwise specified, Figure 2 and Figure 3 The posture of the split mask shown is used as a reference (here only for example, the patient wears the split mask in a standing posture) to define the "up and down" and "left and right" directions. The direction relatively close to the patient's face is the inner side, and the direction relatively far from the patient's face is the outer side. The above orientation definitions are not intended to limit the scope of this application.

[0078] Further, such as Figure 2 , Figure 3 and Figure 4As shown, the nasal mask body 110 may include an oxygen inhalation tube interface 111, a carbon dioxide monitoring interface 112, a nasal pressure sensor 113 and a nasal aspirator interface 114. The nasal mask body 110 may form an oxygen inhalation cavity, which may be a pear-shaped cavity structure with a narrow upper portion and a wide lower portion, and the structure may be well adapted to the patient's face (nose periphery). The oxygen inhalation tube interface 111 may be formed in the middle of the nasal mask body 110, and is used to connect (through a pipeline) an external oxygen supply device to supply oxygen to the nasal mask body 110. The carbon dioxide monitoring interface 112 may be formed near the middle of the nasal mask body 110, and may be formed above the oxygen inhalation tube interface 111 (close to the nose for easy monitoring of nasal exhaled gas), and is used to connect an external carbon dioxide monitoring device to monitor the carbon dioxide content in the patient's exhaled gas, and thus monitor the patient's respiratory state. When the external suction device (described in detail below) is working, the anesthesiologist can appropriately increase the oxygen flow rate according to the carbon dioxide concentration monitored by the carbon dioxide monitoring device (which can be part of the oxygen inhalation device), reduce the frequency of snoring, and reduce the risk of respiratory depression. The nasal pressure sensor 113 can be arranged near the middle of the nasal mask body 110, and in particular, can be formed on one side of the oxygen inhalation tube interface 111 in the left and right directions ( Figure 2 and Figure 4 The nasal mask 110 has a nasal suction port 114, which is used to monitor the patient's breathing state by monitoring the air pressure inside the nasal mask 110, especially to monitor the patient's high-intensity breathing behavior (hiccups, snoring, and coughing, etc.). The nasal suction port 114 can be formed near the middle of the nasal mask 110, especially on the other side of the oxygen inhalation tube port 111 in the left-right direction ( Figure 2 and Figure 4 The left side in the figure) is used to connect to an external suction device to absorb the aerosol inside the nasal mask body 110 to reduce the risk of aerosol-transmitted infection.

[0079] It can be understood that the oxygen tube interface 111, the carbon dioxide monitoring interface 112, the nasal pressure sensor 113, and the nasal suction device interface 114 are centrally arranged in the middle of the nasal mask body 110, that is, the above components are close to the patient's nasal cavity when in use, which can enhance the effect of each component. The oxygen tube interface 111 can achieve high-flow oxygen inhalation for patients through an external oxygen supply device. High-flow oxygen inhalation can improve snoring caused by tongue root fall and pharyngeal soft tissue collapse after anesthesia, and reduce the generation of aerosols. The oxygen tube interface 111 and the external oxygen supply device connected to it can reduce the safety risks of patients with high anesthesia risks such as upper airway obstruction or upper airway obstruction. The carbon dioxide monitoring interface 112 and the external carbon dioxide monitoring device connected to it can monitor the patient's respiratory status.

[0080] like Figure 2 , Figure 3 and Figure 4As shown, the nasal mask 110 may further include a nasal wearing connection portion 115, a nasal seal 116 and a nasal elastic band. The nasal mask 110 may include a plurality of nasal wearing connection portions 115. Preferably, the nasal mask 110 may include two nasal wearing connection portions 115, and the two nasal wearing connection portions 115 may be respectively arranged on both sides of the bottom of the nasal mask 110. The two nasal wearing connection portions 115 may be respectively connected to the two ends of the nasal elastic band, and the nasal mask 110 may be worn on the patient's head and / or neck through the nasal elastic band. The nasal seal 116 may be arranged around the edge of the nasal mask 110, and in particular, may be arranged around the inner side of the edge of the nasal mask 110, so that the nasal mask 110 can fit closely around the patient's nose. The nose seal 116 can enhance the sealing performance of the nasal mask 110 after wearing, reduce the escape of aerosols exhaled from the patient's nasal cavity, and at the same time, can help adapt to the nasal characteristics of different patients and improve the wearing comfort of the patients. Preferably, the nose seal 116 can be an airbag cushion, in particular, an airbag cushion integrally formed of a medical polymer material (such as medical liquid silicone), which can reduce gas leakage in the nasal mask 110.

[0081] Further, such as Figure 2 , Figure 3 and Figure 5 As shown, the oral mask 120 may include an endoscopic inspection port 121, an oral pressure sensor 122 and an oral suction device interface 123. The oral mask 120 may form an endoscopic inspection cavity, which may be a hemispherical cavity (including an ellipsoidal shape) that can cover the oral area. The airflow (aerosol) exhaled from the patient's mouth will form a pressure loss in the oral mask 120, and local high-intensity turbulence may be formed near the endoscopic inspection port 121, which may increase the sedimentation rate of large-particle virus aerosols on the inner wall of the cavity. The endoscopic inspection port 121 may be formed in the middle of the oral mask 120, for passing endoscopic inspection equipment such as a gastroscope. The oral pressure sensor 122 may be arranged near the middle of the oral mask 120, and in particular, may be formed on one side of the endoscopic inspection port 121 in the left and right directions ( Figure 2 and Figure 5 The oral suction device interface 123 can be formed near the middle of the oral mask 120, and can be formed on the other side of the endoscopic inspection port 121 in the left and right direction ( Figure 2 and Figure 5 The left side in the figure) is used to connect to an external suction device to absorb the aerosol inside the oral mask body 120 to reduce the risk of aerosol-transmitted infection.

[0082] It can be understood that due to the split design of the nasal mask body 110 and the oral mask body 120, the structure of the oral mask body 120 may not take into account the patient's oxygen demand, that is, the oral mask body 120 may not be provided with a sealing ring or other structures at the endoscope inspection port 121, so as to facilitate the movement, entry and exit of endoscopic instruments, etc., and improve the accuracy and convenience of the doctor's endoscopic operation. The exhaled aerosol concentration near the endoscope inspection port 121 is the highest and is most likely to escape and cause medical infection, so the oral aspirator interface 123 can be provided near the endoscope inspection port 121.

[0083] Preferably, Figure 2 and Figure 3 As shown, the nasal pressure sensor 113 and the oral pressure sensor 122 can be located on the same side of the split mask (for example, both located on the right side). The nasal aspirator interface 114 and the oral aspirator interface 123 can be located on the other side of the split mask (for example, both located on the left side). This arrangement can facilitate the oral mask body and the nasal mask body to form pipeline connections with external equipment respectively, and can avoid or reduce the crossing and tying of the connecting pipelines, so as to improve the convenience of operation and the aesthetics of the equipment.

[0084] like Figure 2 , Figure 3 and Figure 5 As shown, the oral mask body 120 may also include an oral wearing connection portion 124, an oral seal 125 and an oral elastic band. The oral mask body 120 may include a plurality of oral wearing connections 124. Preferably, the oral mask body 120 may include two oral wearing connections 124, and the two oral wearing connections 124 may be respectively arranged on both sides of the middle of the oral mask body 120. The two oral wearing connections 124 may be respectively connected to the two ends of the oral elastic band, and the oral mask body 120 may be worn to the patient's head and / or neck through the oral elastic band. The oral seal 125 may be arranged around the edge of the oral mask body 120, and in particular, may be arranged around the inner side of the edge of the oral mask body 120, so that the oral mask body 120 may be closely fitted to the patient's oral cavity. The oral seal 125 may enhance the sealing of the oral mask body 120 after wearing, reduce the escape of aerosol exhaled from the patient's oral cavity, and at the same time, it may help adapt to the facial features of different patients, and enhance the wearing comfort of the patient. Preferably, the mouth seal 125 may be an airbag rubber cushion, and in particular, may be an airbag rubber cushion integrally formed of a medical polymer material (such as medical liquid silicone), which can reduce gas leakage in the mouth mask body 120 .

[0085] like Figure 2 , Figure 7 As shown, the oral mask body 120 may further include an inspection port accessory, which may be combined with the oral mask body 120 (especially the endoscopic inspection port 121 thereof) by means of a snap (slot) connection, a threaded connection, a magnetic connection, or the like.

[0086] Preferably, the inspection port accessory can be selected as the first inspection port accessory 126 or the second inspection port accessory 127 according to the actual needs of the patient.

[0087] The first inspection port accessory 126 can be suitable for patients without potential mask ventilation difficulties and risk factors, that is, young and middle-aged patients with a body mass index (BMI) ≤ 26 kg / m 2 , thyroid-chin distance ≥ 8cm, and patients with anesthesia intubation difficulty airway classification standard (Mallampati) graded as grade I to II. The concentration of viral aerosols released during endoscopic examination in such patients is low, mainly due to the splashing of viral aerosol liquid on the tube wall during endoscopic tube removal. Figure 2 and Figure 6 As shown, the first inspection port accessory 126 can be a hollow cone-like structure, which can include two cone-like structures (or bullet-like structures) that are sleeved. The outer top of the first inspection port accessory 126 (the part away from the wearer's mouth) (the top of the outer cone-like structure) can form a valve structure 1261, and the middle part of the valve structure 1261 can form an opening for passing endoscopic inspection equipment. The valve structure 1261 may include multiple valves (blades) for scraping liquid off the tube wall when the endoscope tube is removed. Exemplarily, the valve structure 1261 in this embodiment includes a total of five valves, and the five valves can be arranged adjacent to each other and partially overlap in sequence. When the endoscope tube is removed, the valve shape is at least partially in contact with the endoscope tube, and the airflow (aerosol) exhaled from the mouth can escape outward from the gap between the valves. The opening direction of the gap between the flaps can be consistent with or close to the radial direction of the endoscope tube. When the escaping airflow and aerosol enter and exit the gap between the flaps, multiple (for example, three) local pressure losses can be formed due to the change in flow path diameter and flow direction. In addition, the inertial collision, turbulent sedimentation and gravity deposition effects of the exhaled aerosol are greatly enhanced, so that the sedimentation rate of the exhaled aerosol on the outer wall of the endoscope tube and the inner surface of the flap structure is greatly increased compared with the conventional inspection port structure. A collection groove 1262 can also be formed between the inner and outer conical structures of the first inspection port accessory 126 (between the double-layer material), that is, the inner bottom of the first inspection port accessory 126 (the part close to the wearer's mouth) forms a collection groove 1262, and the flap structure 1261 can scrape the liquid on the tube wall into the collection groove 1262 when the endoscope tube is removed to prevent liquid reflux or splashing. Exemplarily, the wall thickness of the first inspection port accessory 126 can be 1 mm.

[0088] The second inspection port accessory 127 can be used for patients with potential mask ventilation difficulties and risk factors, i.e., older patients (greater than 55 years old) with a body mass index (BMI) greater than 26 kg / m 2, thyromental distance <8cm, and the patient's airway grading standard (Mallampati) for the difficulty of anesthesia intubation is graded as above II. (For example, an elderly patient, routine anesthesia assessment before endoscopy showed a BMI index of 30kg / m 2 , and the thyromental distance is 5cm, Mallampati grading assessment level III, there is a high risk of mask ventilation difficulties). Such patients may have problems such as tongue root falling back after anesthesia and pharyngeal soft tissue collapse leading to snoring during endoscopic examination. The concentration of viral aerosols released is relatively high. In addition to considering the splashing of viral aerosol liquid on the tube wall during the endoscopic tube removal process, the escape of viral aerosols during the endoscopic examination should also be considered. It is recommended to choose the second inspection port accessory 127. Figure 7 and Figure 8 As shown, the second inspection port accessory 127 can be an hourglass-shaped (double funnel-shaped), that is, the diameter of the inside of the second inspection port accessory 127 (the part close to the wearer's mouth) gradually decreases from the inside to the outside, and the diameter of the outside of the second inspection port accessory 127 (the part away from the wearer's mouth) gradually increases from the inside to the outside (the inside and the outside are divided by the axial center of the second inspection port accessory 127). A through hole can be formed in the center of the second inspection port accessory 127 to allow the endoscope tube to pass through. The tapered design of the interior of the second inspection port accessory 127 can form local high-intensity turbulence in a limited space, which can increase the collision effect between large-particle virus aerosols and the wall, and increase the aerosol sedimentation rate. The gradually expanding design of the outside of the second inspection port accessory 127 can increase the pressure loss of the patient's exhaled airflow and effectively reduce the airflow velocity, so that large-particle virus aerosols settle to the inner wall of the outside under the action of gravity. As shown Figure 8 As shown, a filter 1271 may be provided inside the middle of the second inspection port accessory 127. Preferably, the filter 1271 may be a disposable filter cotton ring, which may be made of highly absorbent fiber with strong water absorption and low price, and may have a certain absorption and removal effect on the liquid on the wall of the endoscope tube and the patient's exhaled liquid, and may prevent the liquid from flowing back or splashing.

[0089] The embodiment of the present application also provides a respiratory monitoring system, such as Figure 1 As shown, the respiratory monitoring system may include the above-mentioned split mask 100 , as well as an external suction device 200 and a monitoring controller 300 .

[0090] Specifically, the nasal suction device interface 114 and the oral suction device interface 123 of the split mask 100 can be connected to the external suction device 200 through a hose 220. The nasal pressure sensor 113 and the oral pressure sensor 122 of the split mask 100 can be connected to the monitoring controller 300 through a line. The monitoring controller 300 can be connected to the external suction device 200 through a line to control the external suction device to suck aerosols, particulate matter, etc. in the mask. The monitoring controller 300 can monitor the patient's respiratory pressure waveform curve (especially the patient's respiratory pressure waveform curve during anesthesia), and when the patient's respiratory pressure waveform deviates from the normal value, it can control the external suction device 200 to start the suction operation.

[0091] Preferably, the nasal pressure sensor 113 and the oral pressure sensor 122 can be arranged on (attached to) the inner side (close to the face side) of the nasal mask body 110 and the oral mask body 120, respectively. The nasal pressure sensor 113 and the oral pressure sensor 122 can use flexible film pressure sensors, which are resistive pressure-sensitive sensors. Usually, the thickness of this type of sensor is ≤0.4mm, it is thin and light, resistant to bending and has excellent waterproof performance, can fit the inner wall of the split mask well and does not affect the normal diagnosis and treatment of patients. The response time of the resistive pressure-sensitive sensor is less than 1ms (milliseconds) and the recovery time is less than 15ms, with faster response speed and higher stability. The resistive pressure-sensitive sensor has a long life, low power consumption and low price. The use of this type of sensor can reduce the cost of the mask, especially when the split mask is a disposable mask. The resistance of the resistive sensor decreases as the pressure applied to the sensor surface increases, and the size of the surface pressure can be measured by the pressure-resistance relationship of the sensor. Exemplarily, in the oral mask 120, due to the need for the endoscope to enter and exit, the endoscope inspection port 121 of the oral mask 120 is not completely sealed. When the patient breathes normally, the internal pressure of the oral mask 120 is close to or the same as the external pressure. When the patient snores, hiccups, chokes, etc., he will exhale a high-intensity respiratory airflow, and the dynamic pressure is converted into static pressure and applied to the surface of the oral pressure sensor 122. The surface pressure of the oral pressure sensor 122 increases, and its resistance decreases accordingly, and the output voltage increases. Therefore, the change in respiratory behavior can be judged by the change in the surface pressure waveform output by the nasal pressure sensor 113 and the oral pressure sensor 122. When the surface pressure is greater than the set threshold, it can be considered that the patient has strong respiratory behaviors such as snoring, hiccups, choking, etc.

[0092] Preferably, the threshold for judging strong breathing behavior can be: when the output curve pressure of the nasal pressure sensor 113 and / or the oral pressure sensor 122 increases by ≥10Pa, it is considered that the patient enters a high-intensity breathing mode. The threshold is calculated by calculating the fluid dynamic pressure according to the airflow velocity of snoring, hiccups, and choking. The airflow velocity corresponding to snoring, hiccups, and choking is approximately 5.0-10m / s, 10-20m / s, and 10-50m / s, respectively, and the corresponding dynamic pressure variation range is 12.5-50Pa, 50-200Pa, and 50-1250Pa, respectively. Assuming that the pressure is fully converted into static pressure acting on the surface of the nasal pressure sensor 113 or the oral pressure sensor 122, the pressure variation range can be 12.5-1250Pa, and the minimum pressure variation value is 12.5Pa. In order to ensure the accuracy of the judgment of strong breathing behavior, it can be appropriately lowered on the basis of 12.5Pa, that is, 10Pa is taken as the strong breathing behavior warning threshold.

[0093] like Figure 1 and Fig. 9 As shown, the external suction device 200 may include an electric pump, a waste liquid container 210 and a hose 220, etc. The nasal suction device interface 114 and the oral suction device interface 123 of the split mask 100 can be connected to the waste liquid container 210 of the external suction device 200 through the hose 220, respectively. The monitoring controller 300 can control the operation of the electric pump according to the output pressure monitored by the nasal pressure sensor 113 and / or the oral pressure sensor 122. When the surface pressure of the nasal pressure sensor 113 and / or the oral pressure sensor 122 is less than the set threshold, it can be determined that the patient is in a normal breathing mode, and the electric pump is turned off and does not work. When the surface pressure of the nasal pressure sensor 113 and / or the oral pressure sensor 122 exceeds the set threshold (for example, 10Pa), the electric pump can be started and the aerosol in the nasal mask body 110 and / or the oral mask body 120 can be sucked into the waste liquid container 210 through the hose 220. When the pressure waveform of the monitoring controller 300 returns to the pressure waveform of normal breathing, it can control the electric pump to stop working. The connection between the nasal suction port 114 and the oral suction port 123 of the split mask 100 and the hose 220 can form a silicone seal, and the hose 220 is only plugged in one direction, which can ensure the sealing of the tube hole connection. Exemplarily, the waste liquid container can be a waste liquid bottle, a waste liquid bag, etc.

[0094] It can be understood that the external suction device 200 only operates intermittently and for a short time, which will not affect the patient's normal breathing.

[0095] Preferably, a disposable bag can be provided in the waste liquid container 210 to facilitate cleaning of the waste liquid container. The hose 220 can be a silicone hose, and the wall thickness of the silicone hose can be 1.0-2.0 mm. Fig. 9As shown, a one-way valve 211 may be provided at the connection between the hose 220 and the waste liquid container 210 to prevent liquid backflow.

[0096] Optionally, the external suction device 200 may also have a manual control module. For example, the manual control module may be a foot pedal, which can be actively controlled by the doctor to start the electric pump to absorb the aerosol in the split mask. The external suction device 200 may also have a control switching module, which can realize the free conversion or joint operation of the automatic control mode and the active control mode to adapt to different scene requirements.

[0097] The monitoring controller 300 may include a circuit control module and a liquid crystal display module. The voltage signal output by the nasal pressure sensor 113 and / or the oral pressure sensor 122 may be transmitted to the monitoring controller 300, and the pressure waveform in the split mask may be output in real time through the liquid crystal display module. The circuit control module may include a counter and a controller, etc. When the surface pressure of the nasal pressure sensor 113 and / or the oral pressure sensor 122 is higher than or equal to the strong breathing behavior warning threshold (e.g., 10Pa), it is determined that snoring, hiccups, choking, etc. occur, and the counter may start counting. Exemplarily, when the pressure in the split mask recorded within 10 seconds is higher than the threshold three times or more, the circuit control module may control the external suction device 200 to start working. When the monitored pressure waveform returns to the normal breathing waveform, and the pressure value within 10 seconds is not higher than the set threshold (e.g., 10Pa), the circuit control module may control the external suction device 200 to end the work.

[0098] Optionally, the monitoring controller 300 may have a sound alarm module and / or a silent alarm module to adapt to the alarm mode under different scene requirements.

[0099] It can be understood that the split mask and respiratory monitoring system provided in this embodiment can be applicable to a variety of endoscopic examinations, including but not limited to gastroscopy, esophagoscopy, upper gastrointestinal endoscopy, etc.

[0100] The embodiments of the present application also provide a method for using a respiratory monitoring system, such as Fig.10 As shown, it is suitable for the above-mentioned split mask and respiratory monitoring system.

[0101] The monitoring controller 300 and the external suction device 200 can be preset modules set in the use environment. For example, they can be arranged in advance near the examination bed. Connect the relevant electrical equipment to the power supply. For example, the monitoring controller 300 can be placed on the endoscope equipment suspension, and the external suction device 200 can be set under the examination bed. The waste liquid container 210 (waste liquid bottle / waste liquid bag), hose 220, nasal mask 110 and oral mask 120 of the external suction device 200 can all be disposable items.

[0102] Before the start of endoscopy under general anesthesia, the first inspection port accessories 126 (young and middle-aged, body mass index (BMI) ≤ 26 kg / m) can be selected according to whether the patient has potential risk factors for difficulty with mask ventilation. 2 , thyromental distance ≥ 8 cm, patients with anesthesia intubation difficulty airway classification standard (Mallampati) grading assessment of grade Ⅰ to Ⅱ) or second inspection port accessories 127 (older people, body mass index (BMI) > 26 kg / m 2 , thyromental distance <8cm, the patient's anesthesia intubation difficulty airway grading standard (Mallampati) grading assessment is above grade II), and an endoscopic inspection port 121 is connected to the inlet mask body 120.

[0103] Connect the nasal mask 110 and the oral mask 120. Put the nasal mask 110 and the oral mask 120 on the patient. When putting on the nasal mask 110, one hand holds the nasal mask 110 close to the nasal cavity, and the other hand pulls the wearing rope through the patient's head, and adjusts the wearing rope (for example, adjusts its buckle) to make the nasal mask 110 close (seal fit) and adapt to the patient's head circumference. The oral mask 120 fits the patient's mouth without the need for close fit. The wearing rope is worn around the neck and simply fixed.

[0104] The oxygen inhalation tube and the carbon dioxide monitoring tube of the oxygen inhalation device are connected to the oxygen inhalation tube interface 111 and the carbon dioxide monitoring interface 114 of the nasal mask body 110 respectively. One end of the hose 220 of the external suction device 200 is connected to the suction device interfaces (114, 123) of the nasal mask body 110 and the oral mask body 120, and the other end is connected to the external suction device 200 (three-way interface). The sensor connection line is connected to the nasal pressure sensor 113 and the oral pressure sensor 122.

[0105] After the general anesthesia endoscopic examination process begins, the LCD display module of the monitoring controller 300 can output the pressure change waveform monitored by the nasal / oral pressure sensor in real time. When the pressure is higher than the warning threshold of 10Pa, the circuit control module of the monitoring controller starts and starts counting. When it is higher than 10Pa more than three times within 10s, it is determined that strong breathing behavior has occurred and the control circuit is closed. The external suction device 200 starts working and continuously sucks the aerosol in the nasal / oral mask into the waste liquid container to prevent the aerosol exhaled by the patient's high-intensity breathing behavior from entering the environment and causing medical infection; when the monitored pressure waveform returns to the normal breathing waveform and the pressure value is no higher than 10Pa within 10 seconds, the control circuit can be disconnected and the external suction device 200 ends its work.

[0106] When the external suction device is working, the anesthesiologist can appropriately increase the oxygen flow rate according to the carbon dioxide concentration monitored by the oxygen inhalation device to reduce the frequency of snoring and reduce the risk of respiratory depression. During general anesthesia endoscopy, the digestive tract mucus produced by the doctor inserting and removing the endoscope tube can be removed by the valve structure 1261 of the first inspection port accessory 126 or the filter 1271 of the second inspection port accessory 127 to reduce the risk of medical infection caused by mucus aerosolization during tube removal.

[0107] After the endoscopy under general anesthesia is completed, the connection tube between the nasal mask 110 / oral mask 120 and the external suction device, the circuit connection line of the monitoring controller are unplugged, and the waste liquid container of the external suction device 200 is discarded.

[0108] It can be understood that the order of using the respiratory monitoring system given above is exemplary, and some steps can be omitted or the order can be changed in actual operation.

[0109] The following briefly describes some of the beneficial effects of the above-mentioned embodiments of the present application.

[0110] The split mask provided in the embodiment of the present application can facilitate endoscopic examination without affecting the patient's high-flow oxygen inhalation by separately designing the nasal mask body and the oral mask body. The respiratory monitoring system and the use method provided in the present application can monitor the patient's respiratory condition, especially the patient's high-intensity breathing behavior, and use an external suction device to absorb the aerosol in the mask to reduce the risk of aerosol infection for medical staff.

[0111] It is understood that in the present application, when the number of parts or components is not particularly limited, the number may be one or more, and the multiple here means two or more. For the case where the number of parts or components shown in the drawings and / or described in the specification is a specific number such as two, three, four, etc., the specific number is usually exemplary and not restrictive, and it can be understood as multiple, that is, two or more, but this does not mean that the present application excludes the case of one.

[0112] It should be understood that the above embodiments are merely exemplary and are not intended to limit the present application. Those skilled in the art may make various modifications and changes to the above embodiments under the guidance of the present application without departing from the scope of the present application.

Claims

1. A split mask suitable for endoscopic examination, It is characterized in that The split mask (100) comprises a nasal mask body (110), an oral mask body (120) and a connecting piece (130), wherein the nasal mask body (110) and the oral mask body (120) are connected via the connecting piece (130). The nasal mask body (110) is formed with an oxygen inhalation tube interface (111) for connecting an external oxygen supply device to supply oxygen into the nasal mask body (110); the oral mask body (120) is formed with an endoscopic inspection port (121) for passing an endoscopic inspection device. The nasal mask (110) further comprises a nasal pressure sensor (113) and a nasal aspirator interface (114), which are respectively used to monitor the pressure in the nasal mask (110) and to suck the aerosol in the nasal mask (110), and / or the oral mask (120) further comprises an oral pressure sensor (122) and an oral aspirator interface (123), which are respectively used to monitor the pressure in the oral mask (120) and to suck the aerosol in the oral mask (120). The nasal mask (110) and the oral mask (120) are used to fit the wearer's face respectively without being connected to each other.

2. The split mask according to claim 1, It is characterized in that The oral mask (120) further comprises an inspection port accessory, wherein the inspection port accessory is connected to the endoscope inspection port (121). The connection mode between the inspection port accessory and the endoscope inspection port (121) is one of a snap-on slot connection, a threaded connection, and a magnetic connection.

3. The split mask according to claim 2, It is characterized in that The inspection port accessory is a first inspection port accessory (126), and the first inspection port accessory (126) is a double-layered conical structure. The outer top of the first inspection port accessory (126) forms a flap structure (1261), and the flap structure (1261) includes a plurality of adjacent flaps, which are used to scrape liquid off the wall of the endoscope tube. The inner bottom of the first inspection port accessory (126) forms a collecting groove (1262), and the collecting groove (1262) is formed between the double layers of material of the first inspection port accessory (126) and is used to collect liquid.

4. The split mask according to claim 2, It is characterized in that The inspection port accessory is a second inspection port accessory (127), and the second inspection port accessory (127) is in the shape of an hourglass. The inner diameter of the second inspection port fitting (127) gradually decreases from the inside to the outside, and the outer diameter of the second inspection port fitting (127) gradually increases from the inside to the outside. A filter element (1271) is provided on the inner side of the middle portion of the second inspection port accessory (127) to prevent liquid from flowing back or splashing.

5. The split mask according to claim 1, It is characterized in that The nasal mask body (110) is also formed with a carbon dioxide monitoring interface (112) for connecting an external carbon dioxide monitoring device.

6. The split mask according to claim 1, It is characterized in that The nasal pressure sensor (113) and / or the oral pressure sensor (122) are flexible film pressure sensors.

7. The split mask according to claim 1, It is characterized in that The nasal mask body (110) further comprises two nasal wearing connection parts (115), a nasal sealing member (116) and a nasal elastic band, wherein the two nasal wearing connection parts (115) are respectively arranged on both sides of the bottom of the nasal mask body (110), and the two nasal wearing connection parts (115) are respectively connected to the two ends of the nasal elastic band; and / or The oral mask body (120) further comprises two oral wearing connection parts (124), an oral sealing member (125) and an oral elastic band, wherein the two oral wearing connection parts (124) are respectively arranged on both sides of the middle part of the oral mask body (120), and the two oral wearing connection parts (124) are respectively connected to the two ends of the oral elastic band.

8. A respiratory monitoring system, It is characterized in that include: The split mask according to any one of claims 1 to 7; as well as An external suction device (200) and a monitoring controller (300), The nasal suction interface (114) is connected to the external suction device (200), the nasal pressure sensor (113) is connected to the monitoring controller (300), and / or the oral suction interface (123) is connected to the external suction device (200), and the oral pressure sensor (122) is connected to the monitoring controller (300).

9. The respiratory monitoring system according to claim 8, It is characterized in that The external suction device (200) includes an electric pump and a waste liquid container (210), and the monitoring controller (300) is connected to the electric pump to control the operation of the electric pump. The nasal suction device interface (114) and / or the oral suction device interface (123) are connected to the waste liquid container (210) via a hose (220) to collect aerosols and liquids; and / or the monitoring controller (300) includes a circuit control module and a liquid crystal display module, The circuit control module is connected to the external suction device (200) to control the operation of the external suction device (200). The liquid crystal display module is capable of displaying the pressure curve monitored by the nasal pressure sensor (113) and / or the oral pressure sensor (122).

10. A method of using a respiratory monitoring system, It is characterized in that The respiratory monitoring system according to any one of claims 8 or 9, wherein the split mask comprises a first inspection port accessory (126) or a second inspection port accessory (127); The method of use includes: Assessing the patient's condition and selecting to use the first inspection port accessory (126) or the second inspection port accessory (127) according to the patient's condition; Wearing the nasal mask (110) and the oral mask (120), wherein the nasal mask (110) fits tightly against the patient's head; Connecting the nasal mask (110) and the oral mask (120) to other equipment; An endoscopic examination is performed while monitoring the patient's condition; the external suction device (200) sucks the aerosol in the nasal mask (110) and / or the oral mask (120) according to the pressure value monitored by the monitoring controller (300).

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