Double-air-bag trachea cannula with attaching property detection function

Abstract

The utility model relates to the technical field of medical instruments, in particular to a double-air-bag trachea cannula with an attaching property detection function, one end of an outer cannula of the trachea cannula is a far end, the other end of the outer cannula of the trachea cannula is a near end, and at least one pressure sensor is arranged on the outer surface of the outer cannula of the trachea cannula. The pressure sensor is used for being in contact with an air pipe, being influenced by corresponding pressure changes and converting the pressure changes into electric signals to be output; the far end of the trachea cannula outer cannula is provided with an air bag, the near end of the trachea cannula outer cannula is connected with an inflation tube, the air bag comprises a first air bag and a second air bag, and the inflation tube comprises a first inflation tube and a second inflation tube. The inflating tube is connected with the air pressure indicating balloon; the air pressure indicating balloon is connected with the inflation valve; the inflation valve is used for inflating the air bag. The pressure sensor is arranged on the outer surface of the outer cannula of the trachea cannula to detect the attaching property of the trachea cannula and the trachea, and meanwhile the double air bags are arranged to prevent the situation that the inner wall of the trachea is pressed for a long time due to fixing of a single air bag.

Description

Technical Field

[0001] The present application relates to the technical field of medical devices, and in particular to a double-balloon endotracheal tube with an adhesion detection function. Background Art

[0002] An artificial airway is a crucial measure for mechanical ventilation and the treatment of critically ill patients. An endotracheal tube is a medical device that inserts a flexible plastic or rubber tube into the patient's trachea to maintain airway patency. An endotracheal tube typically consists of an overtube and a stylet. The overtube is inserted into the patient's trachea, while the stylet is inserted inside the overtube to maintain ventilation. The overtube is typically held in place by a cuff, maintaining tight contact with the patient's trachea. Improper cuff pressure management can severely impact patient outcomes. Overinflation of the cuff and excessive pressure can lead to prolonged airway compression, ischemia and necrosis of the airway mucosa, and the proliferation of granulation tissue. Underinflation can cause upper respiratory secretions to leak around the cuff, leading to air leaks during mechanical ventilation. This can lead to complications such as hypoventilation and ventilator-associated pneumonia, prolonging hospital stays, increasing medical costs, and mortality, severely impacting patient outcomes. At the same time, the actual pressure threshold of the patient's trachea varies from person to person. Simply monitoring the air bag pressure is difficult to truly reflect the compression condition of the patient's trachea and the actual shape of the outer tube, and thus it is impossible to make an effective and timely response. Utility Model Content

[0003] In response to the above technical problems, the present application provides a double-balloon endotracheal tube with an adhesion detection function, comprising:

[0004] An endotracheal tube outer cannula, wherein one end of the endotracheal tube outer cannula is a distal end and the other end is a proximal end. The outer surface of the endotracheal tube outer cannula is provided with at least one pressure sensor, which is used to contact the trachea and be affected by corresponding pressure changes and convert the pressure changes into electrical signals for output;

[0005] The distal end of the endotracheal tube outer sleeve is provided with an air bag, and the proximal end is connected to an inflation tube, the air bag includes a first air bag and a second air bag, the inflation tube includes a first inflation tube and a second inflation tube, the first air bag and the second air bag are connected to the first inflation tube and the second inflation tube respectively;

[0006] The inflation tube is connected to the air pressure indicating balloon, and the air pressure indicating balloon includes a first air pressure indicating balloon and a second air pressure indicating balloon. The first inflation tube and the second inflation tube are connected to the first air pressure indicating balloon and the second air pressure indicating balloon respectively.

[0007] The air pressure indicating balloon is connected to the inflation valve, which includes a first inflation valve and a second inflation valve. The first air pressure indicating balloon and the second air pressure indicating balloon are respectively connected to the first inflation valve and the second inflation valve; the inflation valve is used to inflate the airbag, and the air pressure indicating balloon can indicate the air pressure inside the airbag.

[0008] Preferably, the pressure sensor includes an upper substrate, a lower substrate, an upper electrode located on a surface of the upper substrate, a lower electrode located on a surface of the lower substrate, and a pressure sensitive film located between the upper electrode and the lower electrode.

[0009] Preferably, the plurality of pressure sensors constitute a pressure sensor array, and the pressure sensors are arranged in an array;

[0010] The upper electrodes of the pressure sensors located in the same row are connected to each other to form an upper electrode line;

[0011] The lower electrodes of the pressure sensors in the same column are connected to each other to form a lower electrode line.

[0012] Preferably, the electrical signal data collected by the pressure sensor array is converted into an abutment contact force monitoring diagram in combination with the model of the endotracheal tube outer tube.

[0013] Preferably, the pressure intensity level is determined by comparing the electrical signal data collected by the pressure sensor with a pressure intensity reference scale.

[0014] Preferably, a pressure threshold is set for evaluating the adhesion, and the adhesion results include insufficient adhesion, good adhesion, and too tight adhesion. When the adhesion result is insufficient adhesion or too tight adhesion, an alarm is issued.

[0015] Preferably, it also includes:

[0016] An airbag pressure monitor, comprising a first airbag pressure monitor and a second airbag pressure monitor, wherein the first airbag pressure monitor and the second airbag pressure monitor respectively comprise inflation and deflation pipes, the inflation valve being connected to the inflation and deflation pipes of the airbag pressure monitor respectively, the first inflation valve and the second inflation valve being connected to the first airbag pressure monitor and the second airbag pressure monitor respectively, the airbag pressure monitor being capable of monitoring the air pressure inside the airbag, the first airbag pressure monitor and the second airbag pressure monitor being used to monitor the air pressure inside the first airbag and the second airbag respectively.

[0017] Preferably, the airbag pressure monitor includes a data transmission module, a processor, and a user interface for transmitting and displaying airbag pressure data.

[0018] Preferably, the air pressure of the airbag is feedback-regulated through the inflation valve according to the airbag pressure data obtained by the airbag pressure monitor.

[0019] Preferably, a pressure sensor is provided on the outer surface of the airbag, and the pressure sensor includes a first pressure sensor and a second pressure sensor. The first airbag and the second airbag are respectively provided with a first pressure sensor and a second pressure sensor. A pressure sensor is provided on the outer surface of the airbag, and the pressure sensor includes a first pressure sensor and a second pressure sensor. The first airbag and the second airbag are respectively provided with a first pressure sensor and a second pressure sensor.

[0020] The present application sets a pressure sensor on the outer surface of the endotracheal tube outer tube, which can detect the fit between the endotracheal tube and the trachea when the endotracheal tube is placed in the human body, facilitate monitoring and alarm, and avoid situations that are harmful to the human body such as tracheal detachment, air leakage or bloating; at the same time, the airbag inflation can achieve fixation at the distal end of the endotracheal tube outer tube, and the double airbag setting can prevent the inner wall of the trachea from being under pressure for a long time due to a single airbag fixation, which may cause symptoms such as ischemia, erosion, and necrosis of the tracheal mucosa. BRIEF DESCRIPTION OF THE DRAWINGS

[0021] The present application will be further described below with reference to the accompanying drawings.

[0022] Figure 1 This is a schematic structural diagram of a double-balloon endotracheal tube according to an exemplary embodiment of the present application.

[0023] The numbers in the figure represent:

[0024] 1- endotracheal tube outer tube, 2- airbag, 2a- first airbag, 2b- second airbag, 3- inflation tube, 3a- first inflation tube, 3b- second inflation tube, 4- air pressure indicating balloon, 4a- first air pressure indicating balloon, 4b- second air pressure indicating balloon, 5- inflation valve, 5a- first inflation valve, 5b- second inflation valve, 6- pressure sensor, 6a- first pressure sensor, 6b- second pressure sensor, 7- pressure sensor array, 8- airbag pressure monitor, 8a- first airbag pressure monitor, 8b- second airbag pressure monitor. DETAILED DESCRIPTION

[0025] The technical solutions in the embodiments of the present application will be clearly and completely described below in conjunction with the drawings in the embodiments of the present application. Obviously, the described embodiments are only part of the embodiments of the present application, not all of the embodiments. Based on the embodiments in the present application, all other embodiments obtained by ordinary technicians in this field without making creative work are within the scope of protection of this application.

[0026] In the description of this application, it should be understood that the directions or positional relationships indicated by terms such as "front," "back," "left," "right," "up," and "down" are based on the directions or positional relationships shown in the accompanying drawings and are intended only to facilitate the description of this application and simplify the description. They do not indicate or imply that the devices or components referred to must have a specific direction, be constructed and operated in a specific direction. Therefore, they should not be understood as limitations on this application. It should be noted that in this application, "distal end" uniformly refers to the end away from the operating physician, and "proximal end" is just the opposite.

[0027] like Figure 1 As shown, the present application provides a double-balloon endotracheal tube with a contact detection function, comprising:

[0028] An endotracheal tube outer cannula 1, wherein one end of the endotracheal tube outer cannula 1 is a distal end and the other end is a proximal end. The outer surface of the endotracheal tube outer cannula 1 is provided with at least one pressure sensor 6, which is used to contact the trachea and be affected by corresponding pressure changes and convert the pressure changes into electrical signals for output;

[0029] The distal end of the endotracheal tube outer sleeve 1 is provided with an air bag 2, and the proximal end is connected to an inflation tube 3, the air bag 2 includes a first air bag 2a and a second air bag 2b, and the inflation tube 3 includes a first inflation tube 3a and a second inflation tube 3b, the first air bag 2a and the second air bag 2b are connected to the first inflation tube 3a and the second inflation tube 3b respectively;

[0030] The inflation tube 3 is connected to the air pressure indicating balloon 4, and the air pressure indicating balloon 4 includes a first air pressure indicating balloon 4a and a second air pressure indicating balloon 4b. The first inflation tube 3a and the second inflation tube 3b are connected to the first air pressure indicating balloon 4a and the second air pressure indicating balloon 4b respectively.

[0031] The air pressure indicating balloon 4 is connected to the inflation valve 5, and the inflation valve 5 includes a first inflation valve 5a and a second inflation valve 5b. The first air pressure indicating balloon 4a and the second air pressure indicating balloon 4b are respectively connected to the first inflation valve 5a and the second inflation valve 5b; the inflation valve 5 is used to inflate the airbag 2, and the air pressure indicating balloon 4 can indicate the air pressure inside the airbag 2.

[0032] The present application arranges a pressure sensor 6 on the outer surface of the endotracheal tube outer sleeve 1 to detect the fit between the endotracheal tube and the trachea. When the endotracheal tube is placed in the human body, its shape and contour can be observed, which is convenient for monitoring and alarming, and avoids situations such as tracheal leakage or flatulence that are harmful to the human body; at the same time, the airbag inflation can achieve fixation at the distal end of the endotracheal tube outer sleeve 1. The double airbag arrangement can prevent the inner wall of the trachea from being under pressure for a long time, which may occur when a single airbag is fixed. Symptoms such as ischemia, erosion, and necrosis of the tracheal mucosa may occur.

[0033] The pressure sensor is a flexible pressure sensor, specifically a capacitive, resistive, piezoelectric, or thin-film transistor type. In one embodiment, the pressure sensor 6 comprises an upper substrate, a lower substrate, an upper electrode located on the surface of the upper substrate, a lower electrode located on the surface of the lower substrate, and a pressure-sensitive film located between the upper and lower electrodes. The lower substrate is bonded to the outer surface of the endotracheal tube outer tube 1; a pressure-sensitive film preparation material is coated on the surface of either the upper electrode or the lower electrode, the pressure-sensitive film preparation material comprising a foaming material and a thermosetting elastic material; another electrode is placed over the pressure-sensitive film preparation material, with a gap between the pressure-sensitive film preparation material and the other electrode; and the pressure-sensitive film preparation material is heated to form the pressure-sensitive film. After the tracheal tube is inserted into the trachea, the airbag 2 is inflated to fix the tracheal tube in the trachea, the tracheal tube core is ventilated, and the outer tube 1 fits against the inner wall of the trachea, forming a contact force between the two. The pressure sensor 6 collects the contact force through a pressure-sensitive film and converts it into an electrical signal, which can be transmitted through a wired transmission device such as an Ethernet interface, a USB interface, etc., which is suitable for scenarios with high requirements on stability and speed. It can also be transmitted through wireless transmission devices such as WiFi modules, Bluetooth modules, LTE modules, LoRa modules, Zigbee modules, etc., which is suitable for scenarios that require mobility or difficult wiring.

[0034] In another specific embodiment, the multiple pressure sensors 6 form a pressure sensor array 7, which is arranged in an array. The upper electrodes of the pressure sensors 6 in the same row are interconnected to form an upper electrode line, and the lower electrodes of the pressure sensors 6 in the same column are interconnected to form a lower electrode line. Multiple pressure sensors 6 are arranged in an array on the outer surface of the endotracheal tube 1 to form a pressure sensor array 7. This allows for comprehensive collection of contact force between the endotracheal tube 1 and the trachea. Internal data of the trachea can be calculated and simulated based on the contact force data of the tube 1 for medical research.

[0035] In one embodiment, the electrical signal data collected by the pressure sensor array 7 is converted into a contact force monitoring diagram based on the model of the endotracheal tube overtube 1. Real-time monitoring based on the contact force monitoring diagram can accurately locate points of air leakage or flatulence and provide a visual representation of the contact state, providing medical staff and patients with a clear and distinct understanding.

[0036] In a specific embodiment, the pressure intensity level is determined by comparing the electrical signal data collected by the pressure sensor 6 with a pressure intensity reference scale. A pressure threshold is set to evaluate the adhesion, and the adhesion results include insufficient adhesion, good adhesion, and too tight adhesion. If the adhesion result is insufficient adhesion or too tight adhesion, an alarm is issued. The pressure intensity reference scale can be 1, 2, 3, 4, or 5, and the normal pressure threshold is set to 2, 3, or 4. When the electrical signal data indicates that the pressure intensity is 1, it indicates insufficient adhesion and requires inflation or adjustment of the position of the endotracheal tube for reinsertion. When the electrical signal data indicates that the pressure intensity is 5, it indicates that the adhesion is too tight and requires deflation or reinsertion.

[0037] In another specific embodiment, an airway pressure threshold is determined based on the electrical signal data collected by the pressure sensor 6. The pressure threshold can be set based on experimental verification, clinical experience, or a combination of both. The pressure threshold is set to assess fit. The fit results include insufficient fit, good fit, and excessive fit. If the fit result is insufficient fit or excessive fit, an alarm is issued. Generally, the minimum airway pressure alarm threshold is 20 cmH2O or the maximum threshold is 30 cmH2O. However, in practice, it has been found that the thickness of the patient's trachea varies greatly from person to person, and the airway pressure tolerance range is not exactly the same. By recording the imaging results of the tracheal tube overtube 1 in a normal state as historical imaging results during tracheal intubation, and accumulating and studying the processing logs corresponding to the fit electrical signal data of the tracheal tube overtube 1 in different states, data collection, statistics, and improvement can be performed to achieve the purpose of matching the individual patient's tracheal needs. Corresponding treatment measures can also be identified based on the fit results corresponding to the fit electrical signal data. If the level falls below the minimum threshold or exceeds the maximum threshold, an alarm signal in the form of sound, light, etc. is issued to remind medical staff to deal with it in time. The alarm device usually includes components such as a speaker, indicator light, and buzzer.

[0038] In a specific embodiment, if Figure 1 As shown, the tail of the air pressure indicator balloon 4 bifurcates into two branches: one branch is an inflation valve tube with an inflation valve 5 at its mouth, and the other branch is an airbag pressure monitor 8. The tube wall of the airbag pressure monitor 8 is marked with a pressure scale. Inside the tube lumen is a spring. The end of the spring near the inflation valve tube is connected to a circular rubber valve. The diameter of the rubber valve matches the inner diameter of the airbag pressure monitor 8. When the airbag 2 is inflated, the gas pressure passes through the rubber valve and compresses the spring. The scale mark at the edge of the rubber valve indicates the gas pressure within the airbag 2, allowing the air pressure within the airbag 2 to be monitored and adjusted in a timely manner.

[0039] However, the current air pressure control of the airbag 2 mainly relies on syringe inflation, which makes it difficult to control the inflation volume and often makes it difficult to accurately control the airbag pressure due to manual adjustment. In another specific embodiment, it also includes an airbag pressure monitor 8. The airbag pressure monitor 3 includes a first airbag pressure monitor 8a and a second airbag pressure monitor 8b. The first airbag pressure monitor 8a and the second airbag pressure monitor 8b each contain an inflation pipe and a deflation pipe. The inflation valve 5 is connected to the inflation pipe and the deflation pipe of the airbag pressure monitor 8, respectively. The first inflation valve 5a and the second inflation valve 5b are connected to the first airbag pressure monitor 8a and the second airbag pressure monitor 8b, respectively. The airbag pressure monitor 8 is capable of monitoring the air pressure within the airbag 2. The first airbag pressure monitor 8a and the second airbag pressure monitor 8b are used to monitor the air pressure within the first airbag 2a and the second airbag 2b, respectively. The airbag pressure monitor 8 can control the inflation pressure within the airbag 2 and control the alternating inflation and deflation time of the first airbag 2a and the second airbag 2b.

[0040] In a specific embodiment, the airbag pressure monitor 8 includes a data transmission module, a processor, and a user interface for transmitting and displaying airbag pressure data.

[0041] In a specific embodiment, the air pressure of the airbag 2 is feedback-regulated through the inflation valve 5 according to the airbag pressure data obtained by the airbag pressure monitor 8 .

[0042] In one embodiment, the outer diameter of the airbag 2 is larger than the outer diameter of the other parts of the endotracheal tube outer cannula 1, and it fits tightly against the inner wall of the trachea, compressing the inner wall of the trachea to secure the endotracheal tube. If there is only one airbag 2, the inner wall of the trachea corresponding to the airbag 2 is always in a compressed state, which is prone to airway mucosal ischemia, necrosis, granulation tissue hyperplasia, etc. Therefore, the dual airbag configuration allows for rotational fixation to avoid the above-mentioned problems. In this application, by providing a pressure sensor 6 on the outer surface of the airbag 2, it is possible to further monitor the pressure between the airbag 2 and the inner wall of the trachea, and coordinate the inflation and deflation of the dual airbags to avoid loose fixation or excessive air pressure. The pressure sensor 6 includes a first pressure sensor 6a and a second pressure sensor 6b. The first airbag 2a and the second airbag 2b are respectively provided with the first pressure sensor 6a and the second pressure sensor 6b. The outer surface of the airbag 2 is provided with a pressure sensor 6. The pressure sensor 6 includes a first pressure sensor 6a and a second pressure sensor 6b. The first airbag 2a and the second airbag 2b are respectively provided with the first pressure sensor 6a and the second pressure sensor 6b. After the electrical signal data collected by the first pressure sensor 6a indicates that the pressure between the first airbag 2a and the inner wall of the trachea exceeds a certain value or remains within a certain value range for a long time, the airbag pressure of the first airbag pressure monitor 8a is obtained, and the air is quantitatively deflated through the first inflation valve 5a until the contact force electrical signal data of the first pressure sensor 6a meets the requirements. At the same time, the airbag pressure of the second airbag pressure monitor 8b is obtained, and the air is quantitatively inflated through the second inflation valve 5b until the contact force electrical signal data of the second pressure sensor 6b meets the requirements. Through the embodiments described in the present application, the relationship between the airbag pressure and the contact force electrical signal can be gradually established, and a corresponding relationship model can be established to facilitate subsequent automated adjustments.

[0043] The foregoing description describes specific embodiments of the present application. Other embodiments are within the scope of the appended claims. In some cases, the actions or steps recited in the claims can be performed in an order different from that described in the embodiments and still achieve the desired results. Furthermore, the processes depicted in the accompanying drawings do not necessarily require the specific order shown or the sequential order to achieve the desired results. In certain embodiments, multitasking and parallel processing are also possible or may be advantageous.

[0044] Those skilled in the art will readily appreciate other embodiments of the present invention upon considering the specification and practicing this utility model. This application is intended to cover any variations, uses, or adaptations of the present invention that follow the general principles of this application and include common knowledge or customary techniques in the art that are not claimed herein. The description and examples are to be considered merely as exemplary, and the true scope and spirit of the present application are indicated by the following claims.

[0045] It should be understood that the present application is not limited to the exact structures described above and shown in the drawings, and that various modifications and changes may be made without departing from the scope thereof. The scope of the present application is limited only by the appended claims.

[0046] The above description is only a preferred embodiment of the present application and is not intended to limit the present application. Any modifications, equivalent replacements, improvements, etc. made within the spirit and principles of the present application shall be included in the scope of protection of the present application.

Claims

1. A double-balloon endotracheal tube with a contact detection function, characterized in that: include: An endotracheal tube outer tube (1), wherein one end of the endotracheal tube outer tube (1) is a distal end and the other end is a proximal end, and the outer surface of the endotracheal tube outer tube (1) is provided with at least one pressure sensor (6), and the pressure sensor (6) is used to contact with the trachea and be affected by corresponding pressure changes, and convert the pressure changes into electrical signals for output; The distal end of the endotracheal tube outer sleeve (1) is provided with an air bag (2), and the proximal end is connected to an inflation tube (3); the air bag (2) includes a first air bag (2a) and a second air bag (2b); the inflation tube (3) includes a first inflation tube (3a) and a second inflation tube (3b); the first air bag (2a) and the second air bag (2b) are connected to the first inflation tube (3a) and the second inflation tube (3b), respectively; The inflation tube (3) is connected to the air pressure indicating balloon (4), and the air pressure indicating balloon (4) comprises a first air pressure indicating balloon (4a) and a second air pressure indicating balloon (4b). The first inflation tube (3a) and the second inflation tube (3b) are connected to the first air pressure indicating balloon (4a) and the second air pressure indicating balloon (4b), respectively. The air pressure indicating balloon (4) is connected to the inflation valve (5), and the inflation valve (5) comprises a first inflation valve (5a) and a second inflation valve (5b). The first air pressure indicating balloon (4a) and the second air pressure indicating balloon (4b) are connected to the first inflation valve (5a) and the second inflation valve (5b) respectively. The inflation valve (5) is used to inflate the air bag (2), and the air pressure indicating balloon (4) can indicate the air pressure in the air bag (2).

2. The double-balloon endotracheal tube with a contact detection function according to claim 1, characterized in that: The pressure sensor (6) comprises an upper substrate, a lower substrate, an upper electrode located on the surface of the upper substrate, a lower electrode located on the surface of the lower substrate, and a pressure sensitive film located between the upper electrode and the lower electrode.

3. The double-balloon endotracheal tube with a contact detection function according to claim 2, characterized in that: The plurality of pressure sensors (6) constitute a pressure sensor array (7), and the pressure sensors (6) are arranged in an array; The upper electrodes of the pressure sensors (6) located in the same row are connected to each other to form an upper electrode line; The lower electrodes of the pressure sensors (6) located in the same column are connected to each other to form a lower electrode line.

4. The double-balloon endotracheal tube with a contact detection function according to claim 3, characterized in that: The electrical signal data collected by the pressure sensor array (7) is converted into a contact force monitoring diagram based on the model of the endotracheal tube outer tube (1).

5. The double-balloon endotracheal tube with a sticking detection function according to claim 1, characterized in that: The pressure intensity level is determined by comparing the electrical signal data collected by the pressure sensor (6) with a pressure intensity reference scale.

6. The double-balloon endotracheal tube with a sticking detection function according to claim 4 or 5, characterized in that: The pressure threshold is set to evaluate the adhesion. The adhesion results include insufficient adhesion, good adhesion, and too tight adhesion. If the adhesion result is insufficient adhesion or too tight adhesion, an alarm is issued.

7. The double-balloon endotracheal tube with a sticking detection function according to claim 2, characterized in that: Also includes: An airbag pressure monitor (8) includes a first airbag pressure monitor (8a) and a second airbag pressure monitor (8b). The first airbag pressure monitor (8a) and the second airbag pressure monitor (8b) respectively include an inflation pipe and an deflation pipe. The inflation valve (5) is connected to the inflation pipe and the deflation pipe of the airbag pressure monitor (8) respectively. The first inflation valve (5a) and the second inflation valve (5b) are connected to the first airbag pressure monitor (8a) and the second airbag pressure monitor (8b) respectively. The airbag pressure monitor (8) can monitor the air pressure in the airbag (2). The first airbag pressure monitor (8a) and the second airbag pressure monitor (8b) are used to monitor the air pressure in the first airbag (2a) and the second airbag (2b) respectively.

8. The double-balloon endotracheal tube with a sticking detection function according to claim 7, characterized in that: The airbag pressure monitor (8) comprises a data transmission module, a processor, and a user interface, and is used for transmitting and displaying airbag pressure data.

Images