Split-type mask, respiratory monitoring system and use method thereof

Abstract

Provided are a split-type mask, a respiratory monitoring system, and a method of using the same, which are suitable for endoscopic examinations. The split-type mask includes a nasal mask body, an oral mask body, and a connector, wherein the nasal mask body and the oral mask body are connected by the connector. The nasal mask body is formed with an oxygen tube interface for connecting an external oxygen supply device to supply oxygen to the nasal mask body; the oral mask body is formed with an endoscope inspection port for passing an endoscopic examination device such as a gastroscope. The nasal mask body also includes a nasal pressure sensor and a nasal aspirator interface, respectively used to monitor the pressure within the nasal mask body and to aspirate aerosols within the nasal mask body, and / or the oral mask body also includes an oral pressure sensor and an oral aspirator interface, respectively used to monitor the pressure within the oral mask body and to aspirate aerosols within the oral mask body. The nasal mask body and the oral mask body are respectively adapted to fit the wearer's face without being connected to each other.

Description

Technical Field

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

[0002] Gastrointestinal diseases are common in internal medicine, and their diagnosis and treatment often require gastroscopy to examine the patient's digestive tract. Traditional gastroscopy is time-consuming and painful, resulting in a poor patient experience. Painless gastroscopy offers advantages such as high clarity, high resolution, high diagnostic rate, no blind spots, and minimal gastrointestinal damage. Its application in clinical examinations is becoming increasingly widespread.

[0003] In the prior art, most masks used for painless gastroscopy are one-piece masks that fully cover the nose and mouth, and are provided with an inspection hole at the mouth 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 tight, it may cause excessive air pressure inside the mask, affecting the doctor's operation of the gastroscope tube, making it difficult to remove the gastroscope tube and reducing the accuracy of the gastroscopy. However, if a large gap is formed between the inspection hole of the one-piece mask and the gastroscope tube to facilitate the extension and retraction 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, posing certain safety risks.

[0004] Patients undergoing painless gastroscopy typically require intravenous anesthesia and oxygen inhalation via mask. Anesthetics can suppress breathing, leading to slower and shallower breathing and erratic respiratory rhythms. In some cases, this can even cause apnea, severe hypoxemia, and asphyxia. Furthermore, painless gastroscopy is a typical medical procedure that generates high-intensity droplets / aerosols. Droplets / aerosols, as major vectors of respiratory infections, pose a risk of infection for both healthcare professionals and patients. During painless gastrointestinal endoscopy, patients often experience involuntary, high-intensity respiratory behaviors such as hiccups, snoring, and coughing, which can release aerosols / droplets containing high concentrations of viruses. This is particularly true for older patients (over 55 years old), obese patients, those with a short thyromental distance, and those with a high Mallampati grade, who may have difficulty with mask ventilation. Post-anesthesia, high-intensity respiratory behaviors such as snoring are more likely due to tongue retraction and pharyngeal soft tissue collapse. 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) instantaneously.

[0005] Existing endoscopic examinations have improved the oxygen supply problem of the one-piece mask that fully covers the nose and mouth used for 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 requirement of the traditional one-piece mask when used for 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 by the connector.

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

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

[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, which 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 embodiment, 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, which includes a plurality of adjacent flaps for scraping liquid from the wall of the endoscope tube.

[0016] The inner bottom of the first inspection port accessory forms a collecting groove, which 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 embodiment, 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 on the inner side of the middle portion 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 further formed with a carbon dioxide monitoring interface for connecting to 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 further includes two nasal wearing connectors, a nasal seal, and a nasal elastic band, wherein the two nasal wearing connectors are respectively provided on both sides of the bottom of the nasal mask, and the two nasal wearing connectors 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 seal 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 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] An endoscopic examination is performed 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 in this application, with separate nasal and oral housings, facilitates endoscopic examinations while maintaining high-flow oxygen inhalation. The respiratory monitoring system and its use method provided in this application can monitor a patient's respiratory status, particularly high-intensity breathing behavior, and use an external suction device to absorb aerosols within the mask, reducing the risk of aerosol infection for medical staff. BRIEF DESCRIPTION OF THE DRAWINGS

[0038] Figure 1 Schematic diagram of the structure of a respiratory monitoring system according to one embodiment of the present application.

[0039] Figure 2 Schematic diagram of the structure of a split mask according to one embodiment of the present application.

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

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

[0042] Figure 5 Schematic diagram of the structure of an oral mask according to one embodiment of the present application.

[0043] Figure 6 This 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 Schematic diagram of the structure of another split mask according to one embodiment of the present application.

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

[0046] Figure 9 Schematic diagram of the structure of an external suction device according to one embodiment of the present application.

[0047] Figure 10 The present invention is a flowchart 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 part

[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 Oral Wearing 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 filter element

[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 following describes exemplary embodiments of the present application 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 embodiments 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 adapted to fit the wearer's face separately without being connected to each other, so that the nasal mask 110 and the oral mask 120 can operate relatively independently without affecting each other.

[0076] The connector 130 can be a flexible connecting belt, a slot connection, a snap connection, a magnetic connection or other connection forms. The flexible connecting belt can be made of a flexible and elastic material such as a cloth material or a rubber material. The slot connection can be designed with a slot interface on the nasal mask 110 or the oral mask 120. The snap connection can 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 can be made of the same material as the nasal mask and the oral mask and can be integrally formed. The magnetic connection can be designed with a coaxial male end component and a female end component at the connection part of the nasal mask 110 and the oral mask 120. Exemplarily, the shape of the male end component and the female end component can be a circle with a diameter of less than 5 mm, and the number can be 1-2. The male end component and the female end can be embedded in the surface of the nasal mask or the oral mask, and the male end component and the female end component can 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, slot, snap, 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 nose, etc.).

[0077] For the convenience of describing the specific technical solutions of this embodiment, unless otherwise specified, Figure 2 and Figure 3 The "up-down" and "left-right" directions are defined using the illustrated position of a two-piece mask as a reference (this is for illustrative purposes only, with the patient wearing the two-piece mask in a standing position). The direction closer to the patient's face is considered the inside, while the direction farther from the patient's face is considered the outside. These definitions of directions 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 suction device 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, which may better fit the patient's face (nose area). The oxygen inhalation tube interface 111 may be formed in the middle of the nasal mask body 110 and is used to connect (via 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, particularly above the oxygen inhalation tube interface 111 (closer to the nose to facilitate 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, thereby monitoring the patient's respiratory status. When the external suction device (described in detail below) is working, the anesthesiologist can appropriately increase the oxygen flow rate based on the carbon dioxide concentration monitored by the carbon dioxide monitoring device (which can be part of the oxygen inhalation device), thereby reducing the frequency of snoring and the risk of respiratory depression. The nasal pressure sensor 113 can be set near the middle of the nasal mask body 110, and in particular, can be formed on one side in the left and right directions of the oxygen inhalation tube interface 111 ( Figure 2 and Figure 4 The nasal suction port 114 can be formed near the middle of the nasal mask 110, and in particular, can be formed on the other side of the oxygen tube port 111 in the left-right direction ( Figure 2 and Figure 4 The left side in the figure) is used to connect 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 position 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 the patient through an external oxygen supply device. High-flow oxygen inhalation can improve snoring caused by tongue root drop 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 high-anesthesia risk patients with poor upper airway patency 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, 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 nasal seal 116 can enhance the sealing performance of the nasal mask 110 after being worn, reducing the escape of aerosols exhaled from the patient's nasal cavity. Furthermore, it can help adapt to the nasal characteristics of different patients and improve the patient's wearing comfort. Preferably, the nasal seal 116 can be an airbag cushion, particularly an airbag cushion integrally formed from a medical polymer material (e.g., medical liquid silicone), which can reduce gas leakage within 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 cavity) 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 in particular, can be formed on the other side of the endoscopic inspection port 121 in the left and right directions ( Figure 2 and Figure 5 The left side of the figure is used to connect an external suction device to absorb the aerosol inside the mouth mask 120 to reduce the risk of aerosol-transmitted infection.

[0082] It is understood that due to the separate design of the nasal mask 110 and the oral mask 120, the structure of the oral mask 120 can be independent of the patient's oxygen needs. Specifically, the oral mask 120 can be provided without a sealing ring or other structures at the endoscopic inspection port 121. This facilitates the movement and entry and exit of endoscopic instruments, thereby improving the accuracy and convenience of the doctor's endoscopic operation. The exhaled aerosol concentration near the endoscopic inspection port 121 is the highest and is most likely to escape, leading to healthcare worker infection. Therefore, the oral aspirator port 123 can be located near the endoscopic 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 two-piece mask (e.g., both on the right side). The nasal aspirator interface 114 and the oral aspirator interface 123 can be located on the other side of the two-piece mask (e.g., both on the left side). This arrangement facilitates the connection of the oral and nasal mask bodies to external devices through pipelines, avoiding or reducing the risk of interlacing or tangling the connecting lines, thereby improving operational convenience and device aesthetics.

[0084] like Figure 2 、 Figure 3 and Figure 5 As shown, the oral mask 120 may further include an oral wearing connector 124, an oral seal 125, and an oral elastic band. The oral mask 120 may include multiple oral wearing connectors 124. Preferably, the oral mask 120 may include two oral wearing connectors 124, which may be disposed on either side of the middle portion of the oral mask 120. The two oral wearing connectors 124 may respectively connect to the ends of the oral elastic band, allowing the oral mask 120 to be worn on the patient's head and / or neck via the oral elastic band. The oral seal 125 may be disposed around the edge of the oral mask 120, particularly around the inner edge of the oral mask 120, so that the oral mask 120 can fit tightly against the patient's oral cavity. The oral seal 125 may enhance the sealing performance of the oral mask 120 after being worn, reducing the escape of aerosols exhaled from the patient's mouth. Furthermore, it may help adapt to the facial features of different patients and enhance the patient's wearing comfort. Preferably, the mouth seal 125 may 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 mouth mask body 120 .

[0085] like Figure 2 、 Figure 7 As shown, the oral mask 120 may further include an inspection port accessory, which may be combined with the oral mask 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 used 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 level (Mallampati) grading assessment of patients 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 the extubation of the endoscopic tube. 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 arranged in a sleeve. 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 can include multiple valves (blades) for scraping liquid from 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 aligned with or close to the radial direction of the endoscope tube. When escaping airflow and aerosol enter and exit the gap between the flaps, due to changes in flow path diameter and direction, multiple (e.g., three) localized pressure losses can occur. This significantly enhances the inertial collision, turbulent sedimentation, and gravitational deposition effects of the exhaled aerosol, significantly increasing the sedimentation rate of the exhaled aerosol on the outer wall of the endoscope tube and the inner surface of the flap structure compared to conventional inspection port structures. 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). Specifically, the inner bottom of the first inspection port accessory 126 (the portion near the wearer's mouth) forms the collection groove 1262. The flap structure 1261 can scrape liquid from the tube wall into the collection groove 1262 during extubation of the endoscope tube, preventing backflow or splashing of the liquid. 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, such as those who are older (over 55 years old) and have 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 grade II or above. (For example, an elderly patient, routine anesthesia assessment before endoscopy showed a BMI index of 30kg / m 2 , and the thyroid-chin 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 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 extubation of the endoscopic tube, the escape of viral aerosols during the endoscopic examination must 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 hourglass-shaped (double funnel-shaped), that is, the diameter of the interior 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 exterior of the second inspection port accessory 127 (the part away from the wearer's mouth) gradually increases from the inside to the outside (the interior and exterior 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 surface, and increase the aerosol sedimentation rate. The gradually expanding design of the exterior of the second inspection port accessory 127 can increase the pressure loss of the patient's exhaled airflow, effectively reduce the airflow velocity, and allow large-particle virus aerosols to settle to the outer inner wall under the action of gravity. As shown Figure 8 As shown, a filter element 1271 can be provided on the inner side of the middle portion of the second inspection port accessory 127. Preferably, the filter element 1271 can be a disposable filter cotton ring, which can be made of highly absorbent and inexpensive superabsorbent fiber. It can absorb and remove liquid from the endoscope tube wall and patient exhaled fluid to a certain extent, and can prevent liquid reflux 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 port 114 and the oral suction port 123 of the split mask 100 can be connected to the external suction device 200 via 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 via a line. The monitoring controller 300 can be connected to the external suction device 200 via a line to control the external suction device to aspirate 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). When the patient's respiratory pressure waveform deviates from the normal value, the external suction device 200 can be controlled to start the suction operation.

[0091] Preferably, the nasal pressure sensor 113 and the oral pressure sensor 122 can be respectively arranged on (attached to) the inner side (close to the face side) of the nasal mask body 110 and the oral mask body 120. The nasal pressure sensor 113 and the oral pressure sensor 122 can be flexible film pressure sensors, which are resistive pressure-sensitive sensors. Normally, the thickness of this type of sensor is ≤0.4mm, and it is light, thin, bend-resistant and waterproof. It can fit well on the inner wall of the split mask and does not affect the normal diagnosis and treatment of the patient. The response time of the resistive pressure-sensitive sensor is <1ms (milliseconds) and the recovery time is <15ms. It has a fast response speed and high 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 surface pressure can be measured through the pressure-resistance relationship of the sensor. For example, 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 or she 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 changes in respiratory behavior can be judged by the changes in the surface pressure waveforms 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, and choking.

[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 has entered a high-intensity breathing mode. The threshold is calculated by calculating the fluid dynamic pressure based on the airflow rate of snoring, hiccups, and coughs. The airflow rates corresponding to snoring, hiccups, and coughs are approximately 5.0-10m / s, 10-20m / s, and 10-50m / s, respectively, and the corresponding dynamic pressure ranges are 12.5-50Pa, 50-200Pa, and 50-1250Pa, respectively. Assuming that all the pressure is converted into static pressure acting on the surface of the nasal pressure sensor 113 or the oral pressure sensor 122, the pressure range can be 12.5-1250Pa, and the minimum pressure change is 12.5Pa. To ensure the accuracy of the judgment of strong breathing behavior, the pressure can be appropriately lowered based on 12.5Pa, that is, 10Pa is taken as the strong breathing behavior warning threshold.

[0093] like Figure 1 and Figure 9 As shown, the external suction device 200 may include an electric pump, a waste liquid container 210, and a hose 220. The nasal suction port 114 and the oral suction port 123 of the two-piece mask 100 can be connected to the waste liquid container 210 of the external suction device 200 via the hose 220, respectively. The monitoring controller 300 can control the operation of the electric pump based on 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 a set threshold, it can be determined that the patient is in a normal breathing mode, and the electric pump can be turned off and not operate. When the surface pressure of the nasal pressure sensor 113 and / or the oral pressure sensor 122 exceeds a set threshold (e.g., 10 Pa), the electric pump can be activated and aspirate the aerosol in the nasal mask body 110 and / or the oral mask body 120 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 operating. 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 pluggable 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. Figure 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 include a manual control module. For example, the manual control module may be a foot pedal, which allows the physician to actively control the activation of the electric pump to absorb the aerosol within the split mask. The external suction device 200 may also include a control switching module that allows for the flexible switching between automatic and active control modes, or their combined operation, to accommodate different scenarios.

[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 within the split mask may be output in real time via the liquid crystal display module. The circuit control module may include a counter and a controller. When the surface pressure of the nasal pressure sensor 113 and / or the oral pressure sensor 122 exceeds or equals a strong respiratory behavior warning threshold (e.g., 10 Pa), it is determined that snoring, hiccups, choking, or other behaviors have occurred, and the counter may begin counting. For example, when the pressure within the split mask recorded exceeds the threshold three or more times within 10 seconds, the circuit control module may control the external suction device 200 to begin operation. When the monitored pressure waveform returns to a normal respiratory waveform and the pressure value does not exceed the set threshold (e.g., 10 Pa) within 10 seconds, the circuit control module may control the external suction device 200 to terminate operation.

[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 applied 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 Figure 10 As shown, it is applicable to the above-mentioned split mask and respiratory monitoring system.

[0101] The monitoring controller 300 and the external suction device 200 can be pre-set modules installed in the use environment. For example, they can be pre-placed 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 installed in a location such as 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 general anesthesia endoscopy, the first inspection port accessory 126 can be selected based on whether the patient has potential risk factors for difficulty with mask ventilation (young and middle-aged patients with body mass index (BMI) ≤ 26 kg / m 2 , thyroid-mental distance ≥ 8 cm, patients with anesthesia intubation difficulty level (Mallampati) airway classification assessment of grade I to II) or second inspection port accessories 127 (older, body mass index (BMI) > 26 kg / m 2 , thyromental distance <8 cm, the patient's anesthesia intubation difficulty airway grading standard (Mallampati) assessment is grade II or above), and the endoscope 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 oral mask 120 on the patient. When putting on the nasal mask 110, use one hand to hold it tightly around the nasal cavity. With the other hand, pull the wearing cord through the patient's head and adjust the wearing cord (for example, by adjusting its buckle) to ensure a tight fit (sealed fit) and adapt to the patient's head circumference. The oral mask 120 fits snugly around the patient's mouth, but does not require a tight fit. Simply wear the wearing cord around the neck and secure it.

[0104] Connect the oxygen inhalation tube and carbon dioxide monitoring tube of the oxygen inhalation device to the oxygen inhalation tube interface 111 and carbon dioxide monitoring interface 114 of the nasal mask 110, respectively. Connect one end of the hose 220 of the external suction device 200 to the suction device interfaces (114, 123) of the nasal mask 110 and oral mask 120, and the other end to the external suction device 200 (three-way interface). Connect the sensor connection line 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 work.

[0106] When the external suction device is operating, the anesthesiologist can adjust the oxygen flow rate appropriately based on the carbon dioxide concentration monitored by the oxygen inhalation device to reduce the frequency of snoring and mitigate the risk of respiratory depression. During general anesthesia endoscopy, digestive tract mucus generated by the doctor inserting and removing the endoscopic 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, thereby reducing the risk of medical infection caused by mucus aerosolization during extubation.

[0107] After the endoscopy under general anesthesia is completed, the connection tubes 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 is understood that the above-mentioned order of using the respiratory monitoring system is exemplary, and some steps may be omitted or the order may 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-type mask provided in the embodiments of this application, with separate nasal and oral mask sections, facilitates endoscopic examinations while maintaining high-flow oxygen inhalation. The respiratory monitoring system and its use method provided in this application can monitor a patient's respiratory status, particularly high-intensity breathing behavior, and use an external suction device to absorb aerosols within the mask, reducing the risk of aerosol infection for medical staff.

[0111] It is understood that in this application, when the number of parts or components is not specifically limited, the number may be one or more, and the term "plurality" herein refers to two or more. Where the number of parts or components is shown in the drawings and / or described in the specification as a specific number, such as two, three, or four, the specific number is generally illustrative and not restrictive, and may be understood as a plurality, i.e., two or more. However, this does not mean that this 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 based on the teachings of the present application without departing from the scope of the present application.

Claims

1. A split mask suitable for endoscopic examination, characterized in that: The split-type mask (100) comprises a nasal mask body (110), an oral mask body (120) and a connector (130), wherein the nasal mask body (110) and the oral mask body (120) are connected via the connector (130). The nose mask (110) is formed with an oxygen inhalation tube interface (111) for connecting an external oxygen supply device to supply oxygen into the nose mask (110); the mouth mask (120) is formed with an endoscope inspection port (121) for passing an endoscope 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 aspirate 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 aspirate the aerosol in the oral mask (120). The nose mask (110) and the mouth mask (120) are used to fit the wearer's face respectively without being connected to each other. The mouth mask (120) further comprises a first inspection port accessory (126), wherein the first inspection port accessory (126) is connected to the endoscope inspection port (121), 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 middle of the flap structure (1261) forms an opening for passing the endoscopic inspection equipment. The flap structure (1261) includes a plurality of adjacent flaps, which are partially overlapped in sequence and used to scrape liquid from the wall of the endoscope tube. A collecting groove (1262) is formed on the inner bottom of the first inspection port accessory (126). 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.

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

4. The split-type mask according to claim 1, characterized in that: The nasal mask body (110) further comprises two nasal wearing connection parts (115), a nasal seal (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.

5. A split mask suitable for endoscopic examination, characterized in that: The split-type mask (100) comprises a nasal mask body (110), an oral mask body (120) and a connector (130), wherein the nasal mask body (110) and the oral mask body (120) are connected via the connector (130). The nose mask (110) is formed with an oxygen inhalation tube interface (111) for connecting an external oxygen supply device to supply oxygen into the nose mask (110); the mouth mask (120) is formed with an endoscope inspection port (121) for passing an endoscope 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 aspirate 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 aspirate the aerosol in the oral mask (120). The nose mask (110) and the mouth mask (120) are used to fit the wearer's face respectively without being connected to each other. The mouth mask (120) further comprises a second inspection port accessory (127), the second inspection port accessory (127) being connected to the endoscope inspection port (121), the second inspection port accessory (127) being hourglass-shaped. The inner diameter of the second inspection port accessory (127) gradually decreases from the inside to the outside, and the outer diameter of the second inspection port accessory (127) gradually increases from the inside to the outside, so as to promote aerosol deposition. 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.

6. The split-type mask according to claim 5, characterized in that: 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.

7. The split-type mask according to claim 5, characterized in that: The nasal pressure sensor (113) and / or the oral pressure sensor (122) are flexible film pressure sensors.

8. The split-type mask according to claim 5, characterized in that: The nasal mask body (110) further comprises two nasal wearing connection parts (115), a nasal seal (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.

9. A respiratory monitoring system, characterized in that: include: The split face mask according to any one of claims 1 to 8; as well as External suction device (200) and 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).

10. The respiratory monitoring system according to claim 9, 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).

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