Disposable tracheostomy closure device

Abstract

The application discloses a disposable tracheal incision plugging device, which comprises a tube body, the tube body has a tube body channel, the tube body channel comprises a first end and a second end, the tube body comprises a second section located in the trachea and parallel to the trachea and a first section forming an obtuse angle or a right angle with the second section, the first end is located at the first section and outside the trachea, the second end is located at the second section, and an opening in communication with the tube body channel is formed in the first section; a one-way valve is arranged at the first end. The adjusting mechanism comprises a baffle capable of sliding along the first section, the baffle comprises a plurality of training areas distributed along the sliding direction, a through hole is formed in each training area to form a communication part, and the overlapping area of the communication part of different training areas and the opening gradually changes along the moving direction of the baffle. The device can gradually perform independent breathing training, and during the training process, the air bag can be adjusted according to exhalation and inhalation, and the discomfort caused to the trachea during the training is reduced.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to a disposable tracheotomy occlusion device. Background Technology

[0002] The trachea is the tube between the upper respiratory tract and the lungs, carrying air to the lungs and expelling carbon dioxide and phlegm from them. A tracheotomy is a surgical procedure that involves a surgical opening in the front of the neck to create a direct airway through the trachea. The resulting stoma serves as the insertion site for a tracheostomy occlusion device, which then functions as an airway, allowing the person to breathe without using their nose or mouth.

[0003] Current tracheostomy occlusion devices commonly use metal tubes instead of silicone tubes and lack cuffs. However, they lack an emergency access route when completely occluded and require daily cleaning and replacement. Furthermore, tracheostomy occlusion devices often only offer a binary "fully open" or "fully closed" state, lacking a gradual and controllable transition training program. Patients transitioning from complete tracheostomy tube dependence to extubation need to gradually regain supraglottic airway awareness, protective cough reflexes, and spontaneous breathing coordination. Moreover, even if some tracheostomy occlusion devices have cuffs that are fixed in the airway, the cuff's volume often remains constant after inflation, resulting in consistent pressure on the tracheal wall. This can easily cause barotrauma and patient discomfort during transition training. Summary of the Invention

[0004] To overcome the above-mentioned shortcomings, the present invention aims to provide a disposable tracheotomy and occlusion device that can progressively train independent breathing and adjust the air bag according to exhalation and inhalation during the training process to reduce discomfort to the trachea during training.

[0005] To achieve the above objectives, the technical solution adopted by the present invention is: a disposable tracheotomy and occlusion device, comprising: The tube body has a tube body channel, the tube body channel includes a first end and a second end, the tube body includes a second segment located inside the trachea and parallel to the trachea and a first segment forming an obtuse angle or a right angle with the second segment, the first end is located in the first segment and outside the trachea, the second end is located in the second segment, and the first segment has an opening that communicates with the tube body channel; A one-way valve, wherein the one-way valve is disposed at the first end; An adjustment mechanism includes a baffle that can slide along a first segment. The baffle includes multiple training areas distributed along the sliding direction. Each training area has a through hole to form a conductive part. Along the moving direction of the baffle, the overlapping areas of the conductive parts and the openings of different training areas gradually change.

[0006] Furthermore, the training area is provided with four sections, and the overlapping areas of the conductive parts and openings of the four training areas are respectively 1 / 3, 1 / 2, 2 / 3, and the entire cross-sectional area of ​​the opening. The four training areas are aligned with the opening in sequence to gradually perform voluntary breathing training.

[0007] Furthermore, the overlapping area of ​​the conduction portion and the opening in each training area is greater than a threshold value of 3.46 mm². The overlapping area of ​​the conduction portion and the opening must ensure that the training areas meet the requirements for the patient to breathe spontaneously, maintain coughing ability, and achieve the required driving pressure.

[0008] Furthermore, the baffle also includes a blocking area, which can block the opening when aligned with it. The blocking area is adjacent to the training area with the smallest overlap between the guide portion and the opening. When the blocking area and the opening are aligned, the opening can be blocked, and breathing is then performed through the ventilator connected to the first end.

[0009] Furthermore, the baffle is provided with markings that correspond one-to-one with the training area and the blocking area, and the training area or blocking area aligned with the opening is identified by the markings.

[0010] Furthermore, the adjustment mechanism also includes a guide groove and a power component. The guide groove is disposed on the tube body, and a portion of the baffle is embedded in the guide groove and slides along the guide groove. The power component is located on the first section outside the trachea and is used to drive the baffle to slide. The power component is located outside the trachea, and operating the power component can drive the baffle to slide.

[0011] Furthermore, the device also includes an airbag fixed to the second section near the second end. The airbag is connected to a bidirectional air pump located outside the trachea via an air tube. The bidirectional air pump is used to inflate and deflate the airbag. Proper inflation during inhalation aims to ensure effective sealing to prevent leakage and aspiration, making inhalation smoother and closer to physiological states. The positive pressure generated during exhalation assists in the upward movement of airway secretions, which also causes the airbag to compress the tracheal wall. Therefore, deflation of the airbag during exhalation reduces this compression.

[0012] Furthermore, the device also includes a detection mechanism communicatively connected to the bidirectional air pump. This detection mechanism determines whether the trachea is inhaling or exhaling. When the detection mechanism detects exhalation, the bidirectional air pump deflates the airbag; when the detection mechanism detects inhalation, the bidirectional air pump inflates the airbag. The inflation volume of the airbag is automatically adjusted according to the respiratory phase, ensuring that the airbag expands and contracts synchronously with the trachea during spontaneous breathing. That is, during exhalation, the trachea contracts and the airbag deflates; during inhalation, the trachea slightly dilates and the airbag inflates synchronously, reducing or preventing barotrauma.

[0013] Furthermore, the detection mechanism includes a detection tube fixed to the airbag via medical silicone. The detection tube has a detection channel that communicates with the trachea and is parallel to the second segment. One end of the detection tube is inserted into the tube body and communicates with the tube channel. Anti-phlegm blocking meshes are installed at both ends of the detection channel. Temperature sensor one, a heater, and temperature sensor two are sequentially arranged axially within the detection channel. The temperature difference between temperature sensor one and temperature sensor two determines whether the trachea is inhaling or exhaling. The gas flow direction within the detection channel can be determined based on the temperature difference between the two temperature sensors, thus indicating whether the trachea is inhaling or exhaling.

[0014] Furthermore, the detection mechanism also includes a microcontroller, which is fixedly connected to the detection tube and is communicatively connected to the temperature sensor one, the temperature sensor two, and the heater.

[0015] The beneficial effects of this invention are as follows: By setting an adjustment mechanism, the conduction area of ​​the opening and trachea can be adjusted. During the sliding of the baffle, the conduction area of ​​the opening and trachea gradually increases. At this time, there is no need to remove the tube. The sliding baffle can meet the patient's spontaneous breathing and vocalization training at different times, so as to meet the patient's rehabilitation needs. A monitoring system is set up to monitor the trachea's breathing status in real time. During spontaneous breathing training, the inflation volume of the air bag is adjusted in real time according to the breathing status to ensure that the air bag contracts and expands synchronously with the trachea during spontaneous breathing. That is, when exhaling, the trachea contracts and the air bag deflates; when inhaling, the trachea slightly relaxes and the air bag inflates synchronously, reducing or avoiding barotrauma. Attached Figure Description

[0016] Figure 1 This is a usage state diagram of an embodiment of the present invention; Figure 2 This is a cross-sectional view of an embodiment of the present invention; Figure 3 This is a schematic diagram of the baffle structure in an embodiment of the present invention; Figure 4 This is a schematic diagram of the fourth training area and opening alignment in an embodiment of the present invention; Figure 5 This is a schematic diagram of the alignment of the first training area and the opening in an embodiment of the present invention; Figure 6 This is a schematic diagram of the detection mechanism in an embodiment of the present invention.

[0017] In the picture: 1. Pipe body; 11. First section; 111. First end; 112. Opening; 12. Second section; 121. Second end; 1a. Pipe body channel; 2. Check valve; 3. Adjustment mechanism; 31. Baffle; 31a. Through hole; 311. First training area; 312. Second training area; 313. Third training area; 314. Fourth training area; 315. Blocking area; 32. Guide groove; 33. Power component; 4. Airbag; 41. Air tube; 5. Two-way air pump; 6. Testing mechanism; 61. Testing tube; 611. Testing channel; 62. Temperature sensor one; 63. Heater; 64. Temperature sensor two; 65. Microcontroller; 100. Trachea. Detailed Implementation

[0018] The preferred embodiments of the present invention will now be described in detail with reference to the accompanying drawings, so that the advantages and features of the present invention can be more easily understood by those skilled in the art, thereby providing a clearer and more explicit definition of the scope of protection of the present invention.

[0019] The disposable tracheotomy and occlusion device of the present invention is shown in the appendix. Figure 1 and attached Figure 2 As shown, the device includes a tube body 1 with a tube channel 1a open at both ends 112. The tube channel 1a includes a first end 111 and a second end 121. The tube body 1 includes a first segment 11 and a second segment 12. The second segment 12 is completely located within the trachea 100 and is substantially parallel to the trachea 100. The first segment 11 and the second segment 12 form an obtuse angle or a right angle and can pass through the trachea 100. The first end 111 is located in the first segment 11 and outside the trachea 100, and the second end 121 is located in the second segment 12. A one-way valve 2 is inserted into the first end 111 to ensure unidirectional gas flow. The first end 111 can also be connected to a ventilator, in which case the one-way valve 2 is not required.

[0020] At this point, after part of the tube body 1 is inserted into the trachea 100, the second end 121 is close to the carina of the trachea 100, while the first end 111 is located outside the trachea 100. If sputum blockage occurs, the one-way valve 2 can be removed immediately, and sputum can be thoroughly suctioned from the first end 111 to ensure the trachea 100 remains unobstructed. The purpose of the one-way valve 2 here is to act as a seal; if suffocation occurs due to sputum blockage, the one-way valve 2 can be quickly removed, and sputum can be thoroughly suctioned.

[0021] The connection between the first segment 11 and the second segment 12 is smoothly transitioned, and there are no sharp corners in the tube body 1 to facilitate tube insertion. At this time, the tube body 1 can be a whole arc structure or a similar L-shaped structure.

[0022] To ensure patients can perform spontaneous breathing training, the device also includes an opening 112 and an adjustment mechanism 3. The opening 112 is located on the first segment 11 and communicates with the tube channel. The adjustment mechanism 3 includes a baffle 31 that can slide along the first segment 11. The baffle 31 includes multiple training areas distributed along the sliding direction. Each training area has a through hole 31a to form a conductive part, and the overlapping area of ​​the conductive part and the opening 112 of different training areas gradually changes along the moving direction of the baffle 31. The opening 112 is aligned with the channel of the second segment 12.

[0023] In this embodiment, the conduction area of ​​the opening 112 and the trachea 100 is adjusted by setting the adjustment mechanism 3. During the sliding of the baffle 31, the conduction area of ​​the opening 112 and the trachea 100 gradually increases. At this time, it is not necessary to remove the tube 1. Sliding the baffle 31 can meet the patient's spontaneous breathing and vocalization training at different times to meet the patient's rehabilitation needs. The direction of gas flow in the trachea at this time is shown in the attached figure. When the patient performs spontaneous breathing training, there is no need to connect the ventilator.

[0024] For example, see Appendix Figure 3As shown, the baffle 31 includes four training areas: a first training area 311, a second training area 312, a third training area 313, and a fourth training area 314. When the first training area 311 and the opening 112 are aligned, the overlapping area of ​​the conductive portion on the first training area 311 and the opening 112 is greater than the overlapping area of ​​the conductive portion on the second training area 312 and the opening 112 when they are aligned, and the overlapping area of ​​the conductive portion on the third training area 313 and the opening 112 when they are aligned. When the overlapping area of ​​the mouth 112 is greater than the overlapping area of ​​the guiding part on the fourth training area 314 and the opening 112 when the fourth training area 314 and the opening 112 are aligned, the fourth training area 314, the third training area 313, the second training area 312, the first training area 311 and the opening 112 are aligned front to back, so that the guiding area of ​​the opening 112 and the trachea 100 gradually increases. During this process, the patient gradually trains the ability to cough spontaneously, the coordination of spontaneous breathing, the ability to perceive the supraglottic airway, and the ability to attempt spontaneous vocalization.

[0025] Of course, it can also be set such that when the first training area 311 and the opening 112 are aligned, the overlapping area of ​​the conductive part on the first training area 311 and the opening 112 is less than the overlapping area of ​​the conductive part on the second training area 312 and the opening 112 when the second training area 312 and the opening 112 are aligned, the overlapping area of ​​the conductive part on the third training area 313 and the opening 112 when the third training area 313 and the opening 112 are aligned, and the overlapping area of ​​the conductive part on the fourth training area 314 and the opening 112 when the fourth training area 314 and the opening 112 are aligned. In this case, the fourth training area 314, the third training area 313, the second training area 312, the first training area 311 and the opening 112 are aligned.

[0026] In one embodiment, the training area is divided into four regions. The conductive areas of the conductive parts in the four training regions and the opening 112 are respectively 1 / 3, 1 / 2, 2 / 3, and the entire cross-sectional area of ​​the opening 112. For example, when the fourth training region 314 and the opening 112 are aligned, the overlapping area between the conductive part of the fourth training region 314 and the opening 112 is the smallest, at which point the overlapping area is only 1 / 3 of the cross-sectional area of ​​the opening 112; the overlapping area between the conductive part of the third training region 313 and the opening 112 is only 1 / 2 of the cross-sectional area of ​​the opening 112; the overlapping area between the conductive part of the second training region 312 and the opening 112 is only 2 / 3 of the cross-sectional area of ​​the opening 112; and the conductive part of the first training region 311 completely overlaps with or is larger than the opening 112, at which point the opening 112 is fully open, allowing the insertion of a suction catheter for suctioning.

[0027] All four training zones must meet the requirements of allowing the patient to breathe spontaneously, maintain coughing ability, and achieve the target driving pressure. Therefore, the overlapping area of ​​the conduction portion and opening 112 in the training zone needs to be greater than a threshold to satisfy the breathing training requirements. The formula for calculating the threshold is: Where A is the threshold, Cd is the flow coefficient (usually set to 0.7), and Q is the volumetric flow rate. For a normal adult, the tidal volume is 8-10 ml / kg, and the respiratory rate is 12-20 breaths / min. Assuming a tidal volume of 8 ml / kg, a standard weight of 60 kg, and a respiratory rate of 15 breaths / min, a minute ventilation of 7.2 L / min is required, which is Q = 3.77 × 10⁻⁶. -4 m³ / s; ΔP is the driving pressure. When a person is breathing at rest, the pressure difference between the alveoli and the atmosphere is usually very small, about 100-200 Pa; ρ is the air density (taken as 1.2 kg / m³). At this time, the threshold is calculated to be 3.46 mm², which means that the alignment area between the conductive part and the opening of each training area cannot be less than 3.46 mm².

[0028] In one embodiment, the cross-sectional area of ​​the opening 112 is 49mm²-51mm². This size of opening 112 can meet the final extubation training requirements and facilitates suction catheter insertion. The fourth training region 314 has 5-6 through holes 31a, each with a diameter of 2mm; the third training region 313 has 3-4 through holes 31a, each with a diameter of 3mm; the second training region 312 has 2-3 through holes 31a, each with a diameter of 4mm; and the first training region 311 has one through hole 31a, with the same diameter as the opening 112. In this way, each training region can meet the requirement of overlapping area with the opening 112, while ensuring that during exhalation, gas can interact within the overlapping training area of ​​the through hole 31a and the opening 112.

[0029] In one embodiment, see Appendix Figure 3 As shown, the baffle 31 also includes a blocking region 315. When the blocking region 315 is aligned with the opening 112, it can block the opening 112, allowing breathing to be performed through the ventilator connected to the first end 111. The blocking region 315 is adjacent to the training area with the smallest overlap between the guide section and the opening 112. Along the moving direction of the baffle 31, the blocking region 315 is located in front of the training area, meaning that the baffle 31 region is first aligned with the opening 112, and then moves to the training area to be aligned with the opening 112.

[0030] In order for the baffle 31 and the tube 1 to fit together, the baffle 31 is an arc-shaped plate with the same arc shape as the tube 1. At this time, when the baffle 31 slides, it can fit against the outer wall of the tube 1.

[0031] The adjustment mechanism 3 also includes a movement drive component, which is used to drive the baffle 31 to move.

[0032] In one embodiment, see Appendix Figure 4 and attached Figure 5 As shown, the moving drive assembly includes a guide groove 32 and a power component 33. The guide groove 32 is disposed on the tube body 1, and a portion of the baffle 31 is embedded in the guide groove 32 and slides along the guide groove 32. The power component 33 is disposed on the first section 11 located outside the air tube 100. The power component 33 is a rotating rod with two semi-recessed gears. The baffle 31 is provided with a rack that meshes with the gears. When the power component 33 is rotated, the baffle 31 will slide along the guide groove 32, allowing each training area to align with the opening 112 respectively.

[0033] Two guide grooves 32 are provided along the circumference of the pipe body 1. The guide grooves 32 are located on both sides of the opening 112. At this time, the guide grooves 32 guide the baffle from both sides.

[0034] In one embodiment, the power component 33 is a rotating rod that can rotate under the action of an external force. When the rotating rod rotates, the baffle 31 can be wound up or unwound on the rotating rod so that each training area is aligned with the opening 112.

[0035] In one embodiment, the guide groove 32 is located on the outer wall of the tube body 1. However, to facilitate the insertion of the tube body 1 and prevent damage to the trachea due to sharp edges on the outer side of the tube body, a protective silicone is also provided in the area corresponding to the guide groove 32 of the tube body 1. This protects the guide groove portion and keeps the overall outer wall of the device smooth, but the protective silicone will not block the opening 112. Of course, in some embodiments, the guide groove 32 may also be provided on the inner wall of the tube body 1.

[0036] In one embodiment, the baffle 31 is provided with markings corresponding one-to-one with the training area and the blocking area 315. These markings can be distinguished by color or number, and are used to identify the training area or blocking area 315 aligned with the opening 112. For example, when a marking aligned with the fourth training area 314 is seen at the power member 33, it indicates that the fourth training area 314 and the opening 112 are aligned. The markings allow for precise adjustment of the position of the baffle 31.

[0037] In this embodiment, the moving drive component only needs to be able to drive the baffle 31 to move, but the power component 33 needs to be located outside the air pipe 100, that is, set at the position of the first section 11 near the first end 111, so as to facilitate manual operation.

[0038] In one embodiment, in order to facilitate fixing the tube 1 inside the trachea 100 and to open the trachea 100, an air bag 4 is also fixed on the second segment 12. The air bag 4 is fixed at the position of the second segment 12 near the second end 121. When the tube 1 is inserted into the trachea 100, the air bag 4 is inflated to fix the tube 1 inside the trachea 100 and block the area between the tube 1 and the trachea 100, which facilitates suctioning. When it is necessary to remove the tube 1, the air bag 4 is deflated to facilitate the removal of the tube 1.

[0039] The airbag 4 is connected via a venting tube 41 to a bidirectional air pump 5 located outside the air tube 100. The bidirectional air pump 5 can be a diaphragm pump, which inflates and deflates the airbag 4. This bidirectional air pump 5 is existing technology and includes a motor and a diaphragm pump head. The motor operates during inflation and stops operating when deflation is required. The specific structure of the bidirectional air pump 5 is not limited, as long as it can inflate and deflate the airbag 4.

[0040] After the device is inserted into the trachea 100, the air bladder 4 is inflated. However, when performing spontaneous breathing training, the trachea 100 will contract during exhalation and expand during inhalation. If the inflation volume of the air bladder 4 remains unchanged, the volume of the air bladder 4 (that is, the pressure of the air bladder 4) will remain unchanged, but the contracted trachea 100 will cause discomfort.

[0041] In one embodiment, the device further includes a detection mechanism 6, which is communicatively connected to a bidirectional air pump 5. The detection mechanism 6 is used to detect the direction of gas flow within the trachea 100, i.e., the direction of breathing, and thus determine whether the trachea 100 is inhaling or exhaling. When the detection mechanism 6 detects that the trachea 100 is exhaling, the bidirectional air pump 5 deflates the air bag 4; when the detection mechanism 6 detects that the trachea 100 is inhaling, the bidirectional air pump 5 inflates the air bag 4.

[0042] In this embodiment, the device is equipped with an adjustment mechanism 3, which can be used for autonomous breathing training. During this process, considering that the fixed-volume airbag 4 may cause discomfort during training, a detection mechanism 6 is set up to detect the breathing status of the trachea 100 in real time and adjust the inflation volume of the airbag 4 in real time according to the breathing status. This ensures that the airbag expands and contracts synchronously with the trachea during autonomous breathing. That is, when exhaling, the trachea contracts and the airbag deflates; when inhaling, the trachea slightly dilates and the airbag inflates synchronously. This reduces or avoids barotrauma and prevents supraglottic secretions from entering the lower respiratory tract.

[0043] See appendix Figure 6As shown, the detection mechanism 6 includes a detection tube 61 fixed to the airbag 4 via medical silicone. The detection tube 61 has a detection channel 611 that communicates with the trachea 100 and is parallel to the second segment 12. One end of the detection tube 61 is inserted into the tube body and communicates with the tube body channel, while the other end is located outside the tube body. Temperature sensor 62, heater 63, and temperature sensor 64 are sequentially arranged axially within the detection channel 611. In one embodiment, temperature sensor 62 is located near the second end 121, temperature sensor 64 is located near the first end 111, and heater 63 is located between temperature sensor 62 and temperature sensor 64. During exhalation, the gas passes sequentially through temperature sensor 62, heater 63, and temperature sensor 64; during inhalation, the gas passes sequentially through temperature sensor 64, heater 63, and temperature sensor 62.

[0044] In this embodiment, heater 63 does not actively heat the gas. Heater 63 is heated to a fixed temperature difference ΔT above the ambient temperature. ΔT operates in two modes: constant power mode and constant temperature difference mode. Taking the constant temperature difference mode as an example: the goal is to maintain a constant temperature difference ΔT between heater 63 and the upstream reference temperature point or the ambient temperature point. During inhalation, air passes through temperature sensor 62 to measure the temperature value T1, and then passes through heater 63, which lowers the temperature of heating element 63 (decreases ΔT). To maintain a constant ΔT, the control circuit automatically increases the power of heater 63. Similarly, during exhalation, the gas in the body first passes through temperature sensor 64 to measure the temperature value T2, and then passes through heater 63, which lowers the temperature of heating element 63 (decreases ΔT). To maintain a constant ΔT, the control circuit automatically increases the power of heater 63. Because the T2 value during exhalation is higher than the T1 value during inhalation, the power change of the heating element differs in the constant temperature difference mode, thus indicating the change in the respiratory phase.

[0045] A normal adult's spontaneous breathing rate is 12-20 breaths per minute, with a normal inhalation / exhalation ratio of 1:1.5 to 1:2.0. Therefore, at a breathing rate of 20 breaths per minute, one respiratory cycle takes approximately 3 seconds, with an inhalation time of 1 second and an exhalation time of 2 seconds. If breathing is very rapid, reaching 40 breaths per minute, then one respiratory cycle would be approximately 60 / 40 = 1.5 seconds, with an inhalation time of approximately 0.5 to 0.6 seconds and an exhalation time of 0.9 to 1 second. Since the temperature sensor's response time is in the millisecond range, it can provide real-time feedback on temperature changes during respiration.

[0046] The breathing pattern within the trachea 100 is determined by the temperature difference collected by temperature sensor 1 (62) and temperature sensor 2 (64). When the temperature value collected by temperature sensor 1 (62) is greater than that collected by temperature sensor 2 (64), inhalation occurs within the trachea 100, inflating the air bag 4. At this time, gas enters the trachea 100 from the glottis. The gas in the trachea 100 first passes through temperature sensor 2 (64), then is heated by heater 63, and then passes through temperature sensor 1 (62). The heater maintains a constant temperature. Therefore, the gas temperature collected by temperature sensor 1 (62) is greater than the temperature value collected by temperature sensor 2 (64) after being heated by heater 63. Conversely, when the temperature value collected by temperature sensor 1 (62) is less than that collected by temperature sensor 2 (64), exhalation occurs within the trachea 100, deflating the air bag 4. At this time, gas is exhaled from the lungs. The gas in the trachea 100 first passes through temperature sensor 1 (62), then is heated by heater 63, and then passes through temperature sensor 2 (64). Therefore, the gas temperature collected by temperature sensor 2 (64) is greater than the temperature value collected by temperature sensor 1 (62).

[0047] In this embodiment, the gas is heated by heater 63, and the temperature values ​​before and after heater 63 are collected by two temperature sensors. The breathing mode is quickly determined by comparing the temperature values, and then the air volume of airbag 4 is adjusted.

[0048] When the cuff 4 is deflated, the internal pressure of the cuff 4 is reduced to 25 cmH2O, decreasing the pressure of the cuff 4 on the tracheal wall 100 and preventing barotrauma. When the cuff 4 is inflated, the internal pressure of the cuff 4 is increased to 30 cmH2O, maintaining airway closure and preventing supraglottic secretions from refluxing into the lower respiratory tract. The internal pressure of the cuff 4 varies between 25 cmH2O and 30 cmH2O to meet practical usage requirements.

[0049] In one embodiment, anti-phlegm mesh is provided at both ends of the detection channel to prevent phlegm from entering the detection channel and affecting the detection. The inner wall of the detection channel has a superhydrophobic coating to prevent phlegm blockage. For example, the detection tube is made of medical-grade silicone tubing material that meets ISO biocompatibility standards.

[0050] In one embodiment, the detection mechanism 6 further includes a microcontroller 65, which is fixedly connected to the detection tube 61 and communicatively connected to temperature sensor 62, temperature sensor 64, and heater 63. The microcontroller 65, temperature sensor 62, temperature sensor 64, and heater 63 can be fixed on the same substrate. The microcontroller 65 determines the relative temperatures of temperature sensors 62 and 64 and outputs different signals to the bidirectional air pump 5 based on the comparison results. For example, when the microcontroller 65 determines that the temperature value collected by temperature sensor 62 is greater than the temperature value collected by temperature sensor 64, it sends a first signal (e.g., digital signal 1) to the bidirectional air pump 5; when the microcontroller 65 determines that the temperature value collected by temperature sensor 64 is greater than the temperature value collected by temperature sensor 62, it sends a second signal (e.g., digital signal 0) to the bidirectional air pump 5. The bidirectional air pump 5 controls the opening and closing of the motor according to the signals to inflate or deflate the airbag 4.

[0051] The microcontroller 65 and the bidirectional air pump 5 are connected by wired or wireless means, that is, the microcontroller 65 and the bidirectional air pump 5 exchange information through communication cables or wireless, Bluetooth and other means.

[0052] See appendix Figure 2 As shown, the detection mechanism 6 is located on the inner wall (as shown on the right side) of the second section 12 near the first end 111. The detection mechanism will not interfere with the ventilation tube 41. The detection mechanism is located on the inner wall to ensure that the trachea will not be damaged when the whole device is inserted.

[0053] The device also includes a display, which is connected to a microcontroller and a two-way air pump 5. The display can be used to show the breathing direction in the trachea 100 and the pressure in the airbag 4.

[0054] In this embodiment, when the device is in use, the airbag 4 is initially deflated. After the tube 1 is inserted into the trachea 100, the airbag 4 is inflated to seal the trachea 100. When the sealing area 315 and the opening 112 coincide, the opening 112 is closed, and a ventilator is connected to the first end 111 for breathing. During breathing training, the ventilator is removed, and different training areas are aligned with the opening 112 in sequence, gradually increasing the alignment area between the opening 112 and the through hole 31a to complete the breathing training. During the breathing training process, the detection mechanism 6 detects the breathing type in the trachea 100 in real time to determine whether it is exhalation or inhalation, and then adjusts the air volume in the airbag 4 in real time.

[0055] The above embodiments are only for illustrating the technical concept and features of the present invention. Their purpose is to enable those skilled in the art to understand the content of the present invention and implement it. They should not be used to limit the scope of protection of the present invention. All equivalent changes or modifications made in accordance with the spirit and essence of the present invention should be covered within the scope of protection of the present invention.

Claims

1. A disposable tracheotomy and occlusion device, characterized in that: include: The tube body has a tube body channel, the tube body channel includes a first end and a second end, the tube body includes a second segment located inside the trachea and parallel to the trachea and a first segment at an obtuse angle or a right angle to the second segment, the first end is located in the first segment and outside the trachea, the second end is located in the second segment, and the first segment has an opening that communicates with the tube body channel; A one-way valve, wherein the one-way valve is disposed at the first end; An adjustment mechanism includes a baffle that can slide along a first segment. The baffle includes multiple training areas distributed along the sliding direction. Each training area has a through hole to form a conductive part. Along the moving direction of the baffle, the overlapping areas of the conductive parts and the openings of different training areas gradually change.

2. The apparatus according to claim 1, characterized in that: The training area is provided in four parts, and the overlapping area of ​​the conductive part and the opening of the four training areas is 1 / 3, 1 / 2, 2 / 3 and the whole of the cross-sectional area of ​​the opening, respectively.

3. The apparatus according to claim 2, characterized in that: The overlapping area of ​​the conductive portion and the opening on each training region is greater than a threshold value of 3.46 mm².

4. The apparatus according to claim 1, characterized in that: The baffle also includes a blocking area, which can block the opening when aligned with it. The blocking area is adjacent to the training area with the smallest overlapping area between the conductive part and the opening.

5. The apparatus according to claim 4, characterized in that: The baffle is marked with a one-to-one correspondence between the training area and the blocking area.

6. The apparatus according to claim 1, characterized in that: The adjustment mechanism also includes a guide groove and a power component. The guide groove is disposed on the tube body, and a portion of the baffle is embedded in the guide groove and slides along the guide groove. The power component is located on the first section outside the air tube and is used to drive the baffle to slide.

7. The apparatus according to any one of claims 1-6, characterized in that: The device also includes an airbag fixed to the second section near the second end. The airbag is connected to a bidirectional air pump located outside the air pipe via a venting tube. The bidirectional air pump is used to inflate and deflate the airbag.

8. The apparatus according to claim 7, characterized in that: The device also includes a detection mechanism that is communicatively connected to the bidirectional air pump, the detection mechanism being used to determine whether the trachea is inhaling or exhaling; When the detection mechanism detects exhalation through the trachea, the bidirectional air pump deflates the airbag; when the detection mechanism detects inhalation through the trachea, the bidirectional air pump inflates the airbag.

9. The apparatus according to claim 8, characterized in that: The detection mechanism includes a detection tube fixed to the airbag by medical silicone. The detection tube has a detection channel that is connected to the trachea and parallel to the second segment. One end of the detection tube is inserted into the tube body and is connected to the tube body channel. Anti-phlegm blocking mesh is provided at both ends of the detection channel. Temperature sensor one, heater and temperature sensor two are arranged sequentially along the axial direction in the detection channel. The trachea is inhaled or exhaled by comparing the temperatures of temperature sensor one and temperature sensor two.

10. The apparatus according to claim 9, characterized in that: The detection mechanism also includes a microcontroller, which is fixedly connected to the detection tube and is communicatively connected to the temperature sensor one, the temperature sensor two, and the heater.

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