WO2023137936A1

WO2023137936A1 - Ventilation catheter capable of automatically regulating pressure in sealed balloon, and connecting device

Info

Publication number: WO2023137936A1
Application number: PCT/CN2022/094034
Authority: WO
Inventors: 高宏; 高巨; 俞卫锋; 王志萍; 田鸣; 胡大伟; 黄东晓; 熊震天; 张隆盛
Original assignee: 高宏
Priority date: 2022-01-24
Filing date: 2022-05-20
Publication date: 2023-07-27
Also published as: CN114432558A; CN114432558B

Abstract

A ventilation catheter capable of automatically regulating pressure in a sealed balloon, and a connecting device. The ventilation catheter comprises a ventilation catheter body (1) having a front segment provided with a sealed balloon (2), wherein a bias balance adjuster (3) is provided in communication with the sealed balloon (2), and a communication pipe is provided in communication with the bias balance adjuster (3) and is in communication with a breathing circuit. During mechanical ventilation, gas in the breathing circuit automatically adjusts the gas pressure in the sealed balloon (2) by means of the bias balance adjuster (3), so that the gas pressure in the sealed balloon (2) is greater than the gas pressure in the breathing circuit, with the pressure difference being less than 10 mmHg. The pressure in the sealed balloon (2) of the ventilation catheter synchronously and periodically changes with the airway pressure during mechanical ventilation, so that the sealed balloon (2) has relatively small gas pressure during the expiratory phase with small mechanical ventilation airway pressure, and thus the blood circulation of the tracheal mucosa is periodically restored to prevent tracheal mucosa injuries.

Description

A sealed airbag automatic pressure-regulating ventilation catheter and connecting device

technical field

The present invention mainly relates to the field of medical treatment, in particular to the field of medical catheters.

Background technique

General anesthesia or ICU patients need to place a tracheal tube into the trachea through the mouth or nose, and then be assisted by an anesthesia machine or a ventilator. During mechanical ventilation, the head of the endotracheal tube inserted into the trachea is provided with a sealed capsule. In order to ensure the airtightness of the ventilation, an appropriate amount of gas is filled into the sealed capsule. The gas pressure is higher than the airway pressure during mechanical ventilation. Under the pressure of the sealed capsule on the tracheal mucosa, the blood circulation of the tracheal mucosa is blocked, the blood supply is reduced, or even no blood supply.

When the sealing capsule presses the tracheal mucosa for a short period of time, the sealed airbag will be emptied, and after the compression is relieved, the blood circulation will resume, and the oppressed part of the tracheal mucosa will not be seriously affected; if the oppressed for a long time, it will cause slight ischemic necrosis in the oppressed part of the tracheal mucosa, which will easily lead to respiratory tract infection, cough, and even develop into a lung infection, which is extremely detrimental to the recovery of the patient; Serious complications: such as ①tracheoesophageal fistula, which seriously affects the life safety of patients, and the fatality rate is about 50%; ②tracheal mucosal scar formation leads to tracheal stenosis, scars gradually hyperplasia, stenosis gradually aggravates, and even affects the patient's ventilation, requiring tracheal stent placement, but it is only palliative treatment, and the patient will inevitably die; ③tracheothoracic fistula causes tension pneumothorax, and the fatality rate is extremely high if not treated in time; .

In order to reduce the chance of the above complications, the current common clinical methods are:

① When inflating the sealing bag of the endotracheal tube with air, operate accurately and use a pressure gauge to inflate. The general inflation pressure is 30mmHg, but in patients with poor lung compliance, the inflation pressure needs to be increased appropriately. This method avoids excessive inflation pressure of the airbag, minimizes the pressure of the sealed airbag on the tracheal mucosa, and prolongs the time for the tracheal mucosa to withstand compression. However, in patients with long mechanical ventilation, they still cannot escape the outcome of ischemic necrosis;

② In mechanically ventilated patients with endotracheal intubation, the gas in the sealed air bag should be evacuated regularly to temporarily restore blood circulation in the airway mucosa. This method requires more manual intervention, which is time-consuming and labor-intensive. At the same time, when the gas in the sealed airbag is evacuated, the mechanical ventilation leaks seriously, which seriously affects the patient's ventilation effect, affects the patient's oxygenation, and even causes the patient's hypoxia. If the operation is wrong and the gas is not replenished in the sealed air bag in time, it may even lead to extremely serious complications, such as hypoxemia, cardiac arrest, or even death.

③ In patients with tracheal intubation and mechanical ventilation, use a double-sealed-bag endotracheal tube, and regularly replace the compression position of the sealed balloons in turn, so that the tracheal mucosa compressed by the balloons alternates between the two sealed balloons regularly, so that the tracheal mucosa compressed by the balloons can be restored regularly. This method also requires more manual intervention, which is time-consuming and labor-intensive. Improper operation: such as too high gas pressure in the airbag, too long interval between alternate inflation, forgetting to operate, etc., may even cause ischemia and necrosis at the compression site of the two sealed airbags, resulting in double the chance of complications. Even if the management is fully in place, in some patients with poor tolerance, the pressure of 30mmHg will still seriously affect the blood circulation of the tracheal mucosa, and will still lead to ischemic necrosis.

There is an urgent clinical need for a device that is simple to operate and can maintain the blood supply to the compressed part of the air bag while ensuring the airtightness of the endotracheal tube for mechanical ventilation. Similar situations also exist when tubes are placed in other body cavities, and will not be repeated here.

Contents of the invention

Aiming at the above-mentioned defects of the prior art, the present invention provides a sealed airbag automatic pressure-regulating ventilation catheter, which includes a ventilation catheter tube body, and a sealed air bag is provided at the head section of the ventilation catheter tube body.连通所述密封气囊设置偏压平衡调节器，所述偏压平衡调节器包括偏压平衡调压腔和设置在偏压平衡调压腔内的运动密封体，所述运动密封体在偏压平衡调压腔内自由运动，所述偏压平衡调压腔被运动密封体隔离成与密封气囊连通的囊储气腔及与机械通气呼吸回路连通的通气变压腔；所述偏压平衡调压腔内设置偏压弹性体；机械通气时，所述偏压弹性体对运动密封体持续施加由通气变压腔指向囊储气腔的作用力F ₄₃ ，使囊储气腔内气体压强P ₄₁ ≥通气变压腔内气体压强P ₄₂ 。

The invention relates to an automatic pressure regulating connection device for a sealed air bag, comprising a bias balance regulator, the bias balance regulator comprising a bias balance pressure regulating cavity and a moving sealing body arranged in the bias pressure balancing pressure regulating cavity, the moving sealing body moves freely in the bias pressure balancing pressure regulating cavity, and the bias pressure balancing pressure regulating cavity is isolated by the moving sealing body into a bag air storage chamber for communicating with the inflation port of a ventilation catheter and a ventilation variable pressure chamber for communicating with a mechanical ventilation breathing circuit; Air-fixed interface, the ventilation and pressure variable chamber is connected with a breathing connecting tube that matches the breathing circuit; a bias elastic body is arranged in the bias pressure balance pressure regulating chamber; during mechanical ventilation, the bias elastic body continuously exerts a force F directed from the ventilation variable pressure chamber to the air storage chamber of the bag to the moving sealing body ₄₃, so that the gas pressure P in the gas storage chamber of the bag ₄₁≥Gas pressure in the ventilated variable pressure cavity P ₄₂.

Further, the effective cross-sectional area of the moving sealing body in the bias pressure balance pressure regulating chamber is S, and the (F ₄₃ ÷ S)≤10mmHg.

Further, the bias pressure balance pressure regulating chamber is set as a cylindrical cavity, the moving sealing body is set as a piston body matching the cross section of the cylindrical cavity, and the biasing elastic body includes compressive elastic body arranged in the ventilation variable pressure chamber or stretched elastic body arranged in the air storage chamber of the bag.

Further, the moving sealing body is set as a soft diaphragm sealingly connected with the inner wall of the bias pressure balance pressure regulating chamber, and the bias elastic body includes an elastic body integrally provided with the soft diaphragm to protrude into the air storage chamber of the bag, a compression elastic body arranged in the ventilation variable pressure chamber for compression, or a stretching elastic body arranged in the air storage chamber of the bag for stretching.

Further, an elastic valve inflation port is provided to communicate with the air storage chamber of the bag.

Further, the mechanical ventilation breathing circuit includes a ventilation catheter tube body and a breathing connecting tube whose two ends are respectively matched with the ventilation catheter tube body and the breathing threaded tube.

Further, the volume of the sealed airbag or the sealed bag of the ventilation catheter is V ₂ ; the highest gas pressure in the mechanical ventilation breathing circuit is P _max , and the lowest pressure is P _min ; the maximum volume of the air storage chamber of the bag is V _41max , and the minimum volume is V _41min ; the (V _41max -V _41min )≥[(P _max /P _min )-1]×V ₂ .

Further, the outer wall of the cylindrical cavity marks the scale of the pressure generated by the biasing elastic body on the moving sealing body, and the corresponding side wall of the piston body is marked with a reading identification line corresponding to the top of the biasing elastic body.

The bias pressure balance pressure regulating chamber is provided with an alarm, and the cylindrical chamber is provided with alarm contacts on both sides of the moving sealing body. When the top of the moving sealing body touches the alarm contacts, the alarm is triggered to alarm.

Beneficial effects of the present invention:

1. During mechanical ventilation, the inspiratory phase time is shorter and the expiratory phase time is longer (generally 1:2). At the same time, the airway pressure in the inspiratory phase is high (generally not exceeding 25mmHg), and the expiratory phase pressure is low (generally not exceeding 5mmHg); when the device is in the long expiratory phase, the pressure of the sealed airbag is extremely low, and the blood circulation of the tracheal mucosa in the compressed part of the sealed airbag is hardly affected, which can avoid ischemia of the tracheal mucosa;

2. It can ensure that the pressure of the sealed airbag is not less than the airway pressure, so as to ensure the sealing during mechanical ventilation and ensure the safety of oxygenation of the patient;

3. There is no need for too much manual intervention to avoid forgetting. It is only necessary to set the pressure difference between the sealed air bag and the airway at the beginning, or even no need to set.

Description of drawings

Fig. 1 is the sectional structure diagram of first kind of embodiment of the present invention;

Fig. 2 is the cross-sectional structural view of the second embodiment of the present invention

Fig. 3 is the cross-sectional structural view of the third embodiment of the present invention;

Fig. 4 is the exterior view of the fourth embodiment of the present invention;

Fig. 5 is the exterior view of another kind of scheme of the present invention;

Fig. 6 is a schematic diagram of the state before the tracheal intubation of the present invention;

Fig. 7 is a schematic diagram of the state after successful tracheal intubation of the present invention and before the end of mechanical ventilation extubation;

Fig. 8 is a schematic diagram of the state during mechanical ventilation of the present invention;

Fig. 9 is a schematic diagram of setting bias voltage difference scale and reading identification line in the present invention;

Fig. 10 is a structural schematic diagram of an alarm provided in the bias pressure balancing pressure regulating cavity of the present invention;

Number and name: 1-ventilation catheter body, 2-sealed air bag, 3-bias balance regulator, 4-bias balance pressure regulating chamber, 41-bag air storage chamber, 42-ventilation variable pressure chamber, 43-bias elastic body, 44-alarm, 45-alarm contact, 5-moving sealing body, 51-piston body, 52-soft diaphragm, 7-elastic valve inflation port, 8-breathing connection tube, 9-inflatable fixed interface.

Detailed ways

In order to enable those skilled in the art to better understand the technical solutions of the present invention, and to make the above-mentioned features, objectives and advantages of the present invention clearer and easier to understand, the present invention will be further described below in conjunction with embodiments. The examples are only for illustrating the present invention and are not intended to limit the scope of the present invention.

As shown in Figures 1-3, a sealed balloon automatic pressure-regulating ventilation catheter includes a ventilation catheter body 1, and the ventilation catheter body 1 includes various types of tracheal catheter main tubes, such as single-lumen tracheal tubes, double-lumen tracheal tubes, bronchial occluders, and tracheostomy ventilation tubes, etc. During mechanical ventilation, the head section of the ventilation catheter tube body 1 is left in the airway cavity of the patient, and the head section of the ventilation catheter tube body 1 is provided with a sealing air bag 2. By filling the sealing air bag 2 with an appropriate amount of gas, the pressure of the sealing air bag 2 is stronger than the airway ventilation pressure, and the sealing air bag 2 is fully in contact with the mucous membrane in the airway cavity, so as to provide ventilation sealing for the mechanically ventilated lung tissue. These basic structures are basically similar to the existing ventilation catheters, and will not be repeated here.

During mechanical ventilation, the inspiratory phase is shorter and the expiratory phase is longer (generally 1:2). At the same time, the inspiratory phase airway pressure is high (generally not exceeding 25mmHg), and the expiratory phase pressure is low (generally not exceeding 5mmHg). The purpose of the present invention is to adjust the gas volume in the sealed airbag 2 to make the gas pressure in the sealed airbag 2 smaller in the expiratory phase when the time ratio is long and the airway pressure is low, so as to further reduce the pressure of the sealed airbag 2 on the airway mucosa. The airbag 2 compresses the tracheal mucosa in the expiratory phase where the time is relatively long and the pressure is low, the blood circulation is intermittently restored, and the blood circulation that accounts for almost 2/3 of the ventilation time is basically not affected, thereby avoiding ischemia of the tracheal mucosa.

In order to achieve the above design goals, what is different from the existing ventilation catheter is that the present invention connects the sealed airbag 2 with a bias balance regulator 3, and the function of the bias balance regulator 3 is to keep the gas pressure of the sealed airbag 2 and the gas pressure in the breathing circuit in a non-isobaric balance during mechanical ventilation. That is to say, the gas pressure of the sealed airbag 2 is higher than the gas pressure in the breathing circuit, and the difference between the gas pressure in the sealed airbag 2 and the breathing circuit is optimally controlled between 2mmHg-8mmHg. The airway gas pressure fluctuates between 3mmHg-12mmHg in most patients during mechanical ventilation; the pressure in the expiratory phase is low, mostly 1mmHg-2mmHg, generally not exceeding 3mmHg; the pressure in the inspiratory phase is high, mostly 10mmHg-15mmHg; patients with poor lung compliance rarely exceed 30mmHg. By controlling the difference between the gas pressure in the sealed airbag 2 and the breathing circuit at 2mmHg-8mmHg, the gas pressure in the sealed airbag 2 (that is, the pressure of the sealed airbag 2 on the airway inner wall mucosa) can be controlled to fluctuate between 5mmHg-18mmHg. The expiratory phase, which takes a long time, is relatively low, about 5mmHg, so that the blood circulation of the inner wall of the airway is hardly affected during the expiratory phase, thereby completely avoiding ischemic damage to the inner wall of the airway (mainly the trachea or bronchi).

为实现上述目标，所述偏压平衡调节器3包括偏压平衡调压腔4和设置在偏压平衡调压腔4内的运动密封体5，所述运动密封体5在偏压平衡调压腔4内自由运动，所述偏压平衡调压腔4被运动密封体5隔离成与密封气囊2连通的囊储气腔41及与机械通气呼吸回路(包括整个机械通气呼吸回路的任意部位)连通的通气变压腔42；所述偏压平衡调压腔4内设置偏压弹性体43(最佳选择为弹簧)；机械通气时，所述偏压弹性体43对运动密封体5持续施加由通气变压腔42指向囊储气腔41的作用力F ₄₃ ，使囊储气腔41内气体压强P ₄₁ ≥通气变压腔42内气体压强P ₄₂ 。 In fact, the ventilation variable pressure chamber 42 is connected with the mechanical ventilation breathing circuit, and the gas pressure P42 in the ventilation variable pressure chamber 42 is the same as the ventilation pressure in the patient's airway during mechanical ventilation, that is, the gas pressure P42 in the ventilation variable pressure chamber ₄₂ is exactly the ventilation pressure P airway in the patient's airway during mechanical ventilation (that is, P _airway = _P42 ); The gas pressure in the airbag 2 is the same as , that is, the gas pressure P ₄₁ in the airbag storage _cavity ₄₁ is the gas pressure _{P 2} _in the sealed airbag 2 (ie, P ₂ =P ₄₁ ).运动密封体5在囊储气腔41和通气变压腔42之间能自由运动，运动密封体5保持自由运动时，运动密封体5在囊储气腔41和通气变压腔42两侧的压力保持动态平衡，即偏压弹性体43对运动密封体5持续施加由通气变压腔42指向囊储气腔41的作用力F ₄₃和通气变压腔42内气体压强对运动密封体5的作用力F ₄₂ (为通气变压腔42内气体压强P ₄₂与运动密封体5横截面S的乘积，即F ₄₂ ＝P ₄₂ ×S)之和(F ₄₃ +F ₄₂ )与囊储气腔41内气体压强对运动密封体5的作用力F ₄₁ (为囊储气腔41内气体压强与运动密封体5横截面S的乘积，即F ₄₁ ＝P ₄₁ ×S)之间保持动态平衡，即(F ₄₃ +F ₄₂ )＝F ₄₁ 。 In this way, when the bias elastic body 43 is continuously applied to the moving sealing body 5 by the force directed from the ventilation variable pressure chamber 42 to the bag air storage chamber 41 and the moving sealing body 5 moves freely:

(1)∵F ₄₁ ＝(F ₄₃ +F ₄₂ ), F ₄₃ >0;

∴F ₄₁ >F ₄₂ ; and ∵F ₄₁ =P ₄₁ ×S, F ₄₂ =P ₄₂ ×S;

∴ P ₄₁ ×S >P ₄₂ ×S;

∴P ₄₁ ＞P ₄₂ ; and ∵P ₂ ＝P ₄₁ , P _airway ＝P ₄₂ ;

∴P ₂ >P _airway . ①

(2)∵F ₄₁ ＝(F ₄₃ +F ₄₂ ), F ₄₃ >0;

∴F ₄₃ =(F ₄₁ -F ₄₂ ); and ∵F ₄₁ =P ₄₁ ×S, F ₄₂ =P ₄₂ ×S

∴ F ₄₃ = (P ₄₁ ×SP ₄₂ ×S);

∴ (F ₄₃ ÷ S) = (P ₄₁ -P ₄₂ );

∴P ₄₃ ＝(P ₄₁ -P ₄₂ ); and ∵P ₂ ＝P ₄₁ , P _airway ＝P ₄₂ ;

∴ P ₄₃ = (P ₂ -P _airway ), ②; P _airway > 0, P ₄₃ >0;

∴P ₂ =(P _airway +P ₄₃ )>0. ③

Note: The biasing elastic body 43 continuously exerts force on the moving sealing body 5 from the ventilation variable pressure chamber 42 to the air storage chamber 41 of the bag, and the pressure generated by it on the moving sealing body 5 and directed to the air storage chamber 41 of the bag is P ₄₃ .

① P ₂ > P _airway can ensure that during mechanical ventilation, the pressure of the sealed air bag 2 on the inner wall of the airway is greater than the pressure of the gas in the airway, thereby ensuring the ventilation seal during mechanical ventilation and ensuring the safety of mechanical ventilation. According to ③P2=(P _airway + _P43 ), during mechanical ventilation, the pressure of the sealed airbag 2 on the inner wall of the airway changes with the change of the gas pressure in the airway, and the difference is P43 _, that is, the pressure generated by the biasing elastic body 43 on the moving sealing body 5 and directed to the air storage cavity 41 of the bag. Select the biasing elastic body 43 with appropriate strength, so that P ₄₃ is optimal at 2mmHg-8mmHg. When mechanical ventilation is actually applied, the P _airway accounts for about 1/3 of the time in the inspiratory phase, which is about 15mmHg-20mmHg, and the patient with poor lung compliance is about 25mmHg-32mmHg; at the same time, the P _airway accounts for about 2/3 of the time during the expiratory phase, which is about 2mmHg-5mmHg, and the patient with poor lung compliance is about 5mmHg-8mmHg. At this time, the blood supply to the inner wall of the airway is almost Unaffected, it can ensure the safety of the airway inner wall mucosa.

另一种解决方案，如图5所示，一种密封气囊自动调压连接装置，包括偏压平衡调节器3，所述偏压平衡调节器3包括偏压平衡调压腔4和设置在偏压平衡调压腔4内的运动密封体5，所述偏压平衡调压腔4被运动密封体5隔离成用于与通气导管充气口连通的囊储气腔41及用于与机械通气呼吸回路连通的通气变压腔42；所述囊储气腔41连通设有与通气导管的充气口匹配的充气固定接口9，所述通气变压腔42连通设有与呼吸回路匹配的呼吸衔接管8；所述偏压平衡调压腔4内设置偏压弹性体43；机械通气时，所述运动密封体5在偏压平衡调压腔4内自由运动，所述偏压弹性体43对运动密封体5持续施加由通气变压腔42指向囊储气腔41的作用力F ₄₃ ，使囊储气腔41内气体压强P ₄₁ ≥通气变压腔42内气体压强P ₄₂ 。 Its working principle is exactly the same as the above-mentioned structure, except that it is arranged with the ventilation catheter body 1. In this solution, the ventilation catheter body 1 is replaced by the ventilation catheter, which is consistent with the existing ventilation catheter. When in use, it is only necessary to connect the inflation fixed interface 9 to the inflation port of the ventilation catheter, and connect the breathing connecting tube 8 to the breathing circuit during mechanical ventilation. The ventilation catheter includes a single-lumen tracheal tube, a double-lumen tracheal tube, a bronchial occluder, a tracheostomy tube, etc., and the principles thereof will not be repeated here.

In actual implementation, the effective cross-sectional area of the moving sealing body 5 in the bias pressure balance pressure regulating chamber 4 is S, and the (F ₄₃ ÷ S) ≤ 10mmHg. That is to say, when the bias elastic body 43 is deformed to the maximum, the ratio of its elastic force F _43max to the effective cross-sectional area S of the moving sealing body 5 in the bias balance pressure regulating chamber 4 is not greater than 10mmHg, that is, P ₄₃ ≤ 10mmHg. From this we learned that:

∵P ₄₃ ≤10mmHg, and because P ₄₃ = (P ₂ -P _airway )②;

∴ (P ₂ -P _airway ) ≤ 10mmHg;

Therefore, it can be ensured that during ventilation, the gas pressure P2 in the sealed airbag ₂ is greater than _the ventilation pressure P _airway in the patient's airway, and the pressure difference between the two is not greater than 10 mmHg.实际上，机械通气吸气时，患者气道内通气压强P_气道较高，所述密封气囊2内气体压强P ₂与P_气道动态平衡，也相对较高，根据波意尔定律：P ₁ V ₁ ＝P ₂ V ₂ (等温等摩尔数气体，此处P ₁ 、V ₁ 、P ₂ 、V ₂为公式表达符号，与文案中其它相同字母意义无关)，密封气囊2内气体相对被压缩后较小，所述运动密封体5位于偏压平衡调压腔4内相对临近密封气囊2一侧；此时，偏压弹性体43变形程度相对较小，即F ₄₃相对较小，即P ₄₃相对较小，(P ₂ -P_气道) 相对较小。 Similarly, during the expiratory phase of mechanical ventilation, the ventilation pressure P _airway in the patient's airway is relatively low, the gas pressure _P2 in the sealed airbag 2 is dynamically balanced with the P _airway , and is also relatively low, the gas in the sealed airbag 2 is relatively inflated, and the moving sealing body 5 is located in the bias pressure balance pressure regulating chamber 4 and is relatively far away from the side of the sealed airbag 2; at this time, the degree of deformation of the bias elastic body 43 is relatively large, that is, F ₄₃ is relatively large, that is, P ₄₃ is relatively large, and (P ₂ -P _airway ) is relatively large. Accompanied by the alternation of the inspiratory phase and the expiratory phase of the mechanical ventilation, the moving sealing body 5 reciprocates left and right in the bias pressure balancing pressure regulating chamber 4 .

During specific implementation, the amplitude of the reciprocating movement of the moving sealing body 5 in the bias pressure balance pressure regulating cavity 4 is determined by the pressure of the gas filled in the sealed air bag 2 . The higher the gas pressure in the sealed airbag 2, the smaller the reciprocating range of the moving sealing body 5; the smaller the gas pressure in the sealing airbag 2, the larger the reciprocating range of the moving sealing body 5.

Further, the bias pressure balance and pressure regulating chamber 4 is set as a cylindrical cavity, the moving sealing body 5 is set as a piston body 51 matching the section of the cylindrical cavity, and the bias elastic body 43 includes a compressed elastic body that is compressed and set in the ventilation variable pressure cavity 42 or a stretched elastic body that is stretched and set in the air storage cavity 41 of the bladder.图1中，所述偏压弹性体43设置为弹簧，弹簧一端连接在运动密封体5上，另一端连接在所述筒状腔的偏压平衡调压腔4远离密封气囊2一侧的端部，所述弹簧的偏压弹性体43始终位于压缩状态，始终对运动密封体5施加由通气变压腔42指向囊储气腔41的作用力F ₄₃ ，从而达到在机械通气时弹簧的偏压弹性体43对运动密封体5持续施加由通气变压腔42指向囊储气腔41的压强P ₄₃ ，使囊储气腔41内气体压强P ₄₁ ≥通气变压腔42内气体压强P ₄₂ 。若将所述偏压弹性体43设置为拉伸的弹簧体，弹簧一端连接在运动密封体5上，另一端连接在所述筒状腔的偏压平衡调压腔4临近密封气囊2一侧的端部，所述弹簧的偏压弹性体43始终位于拉伸状态，始终对运动密封体5施加由囊储气腔41指向囊储气腔41与密封气囊2接触部的作用力F ₄₃ ，从而达到在机械通气时弹簧的偏压弹性体43对运动密封体5持续施加由囊储气腔41指向囊储气腔41与密封气囊2接触部的压强P ₄₃ ，使囊储气腔41内气体压强P ₄₁ ≥通气变压腔42内气体压强P ₄₂ 。

It is worth reminding that if the moving sealing body 5 adopts the piston body 51, in order to achieve the best effect, the smaller the friction force between the piston body 51 and the cylindrical cavity, the bias balance pressure regulating chamber 4, the better. At present, a low-resistance syringe has been developed clinically. Patent No.: CN1736501A, CN104759005B, CN204619057U, CN204017037U, CN105709310A, etc., the piston and needle The tightness between the cylinders is excellent, and the frictional force is also extremely small, which can fully meet the target requirements of the solution of the present invention, and will not be repeated here.

Further, the moving sealing body 5 is set as a soft diaphragm 52 that is sealed and connected to the inner wall of the bias pressure balance and pressure regulating chamber 41, and the bias elastic body 43 includes an elastic body that is integrated with the soft diaphragm 52 and protrudes into the air storage chamber 41 of the bag, compresses the elastic body that is arranged in the ventilation variable pressure chamber 42, or stretches the elastic body that is arranged in the air storage chamber 41 of the bag.

As shown in Figure 2, the bias elastic body 43 is a compressed elastic body (spring) arranged in the ventilating and pressure-changing cavity 42. Its working principle is basically the same as that in FIG. Matching can reduce or avoid the influence of frictional force on the reciprocating movement of the piston body 51 in the bias pressure balance pressure regulating cavity 4 . In order to achieve the best effect, the central reciprocating part of the soft diaphragm 52 should adopt hard light-duty materials and be fixedly connected with the spring; the peripheral parts of the soft diaphragm 52 should adopt non-elastic soft materials, so as to avoid interfering with the effect of the P ₄₃ due to the elastic deformation of the soft diaphragm 52. If the biasing elastic body 43 is a stretching elastic body stretched and arranged in the gas storage chamber 41 of the bladder, its working principle is the same as that in FIG. 2 , and will not be repeated here.

As shown in Figure 3, the biasing elastic body 43 is an elastic body with protrusions extending into the air storage cavity 41 of the bag. This is actually a simplified solution of FIGS. The force F ₄₃ directed to the gas storage cavity 41 of the bag can reach the gas pressure P ₄₃ acting in the gas storage cavity 41 of the bag during mechanical ventilation, so that the gas pressure P 41 in the gas storage cavity 41 ≥ the gas pressure P ₄₂ in the ventilation variable pressure cavity ₄₂ .

Further, as shown in FIGS. 1-5 , an elastic valve inflation port 7 is provided to communicate with the bag air storage chamber 41 . Before endotracheal intubation, it is necessary to connect the syringe to the inflation port 7 of the elastic valve, and discharge the gas in the sealing air bag 2 of the ventilation catheter body 1 or the sealing bag of the ventilation catheter, so that the sealing air bag 2 or the sealing bag membrane body is closely attached to the body 1 of the ventilation catheter or the head section of the ventilation catheter, so as to reduce the maximum outer diameter of the intubation and reduce the friction damage to the glottis and airway at this part.

Further, as shown in FIG. 4 , the mechanical ventilation breathing circuit includes a ventilation catheter tube body 1 and a breathing connecting tube 8 whose two ends are respectively matched with the ventilation catheter tube body 1 and the breathing threaded tube. This is a variation of Fig. 1-3. In Fig. 1-3, the ventilation variable pressure chamber 42 is directly communicated with the inner cavity of the ventilation catheter tube body 1; The breathing connecting tube 8 is very common in mechanical ventilation, and is used to connect the front and rear segments of the breathing pipeline, and its two ends have fixed calibers, which will not be repeated here.

Further, the volume of the sealing air bag 2 or the sealing bag of the ventilation catheter is V ₂ . In fact, the volume _V2 of the sealed air bag 2 or ventilation catheter sealing bag refers to the sum of the internal volume of the sealing air bag 2 or ventilation catheter sealing bag and the volume of the pipeline connected to the bias balance regulator 3 . The smaller ventilator of model, its V ₂ volume is smaller, and the implementation difficulty of the present invention is smaller; The larger ventilator of model, its V ₂ Volume is bigger, and the implementation difficulty of the present invention is bigger; But even the ventilator of largest model, its volume also can not exceed 20ml (mostly is about 10ml), gets its limit value here as: V ₂ =20ml.

The highest gas pressure in the mechanical ventilation breathing circuit is P _max , and the lowest pressure is P _min . The gas pressure in the mechanical ventilation breathing circuit is the airway pressure of the patient during mechanical ventilation. It is higher during the inspiratory phase, generally below 15mmHg for normal people, and may be higher for special patients, generally not exceeding 30mmHg. Here we take its limit value and take the highest adjustable value of the safety pressure valve of the anesthesia machine as 70mmHg. The airway pressure of mechanically ventilated patients is always positive, and the expiratory airway pressure generally does not exceed 5mmHg, and we take the limit value as 0mmHg; the values here are relative values marked with the standard atmospheric pressure of 760mmHg as the zero point, and the absolute pressure values are: P _max is (760+70)mmHg=830mmHg; P _min is (760+0)mmHg=760mmHg.

The bag gas storage chamber 41 is actually the cavity of the bias balance pressure regulating chamber 4 on the side of the moving sealing body 5 adjacent to the sealed air bag 2 or the sealed bag. Inspiratory phase, when airway pressure is higher, moving sealing body 5 moves to sealing air bag 2 or sealing bag, and the gas in bag air storage chamber 41 enters in sealing air bag 2 or sealing bag, and inspiratory end bag gas storage chamber 41 interior gas volume reaches minimum value, is V _41min ; Exhalation phase, when airway pressure is low, moving sealing body 5 moves to sealing air bag 2 or sealing bag, and the gas in bag air storage chamber 41 enters in sealing air bag 2 or sealing bag, and in end-expiration bag gas storage chamber 41 The gas volume reaches its maximum value, V _41max . The difference between V _41max and V _41min is actually the difference produced by the volume difference of the sealed air bag 2 or the gas in the sealed bag under different pressures; the maximum air pressure in the sealed air bag 2 or the sealed bag is set as P _max , and the minimum air pressure is P _min , according to Boyle’s law:

P _max ×(V ₂ +V _41min )=P _min ×(V ₂ +V _41max ); deduce:

(P _max /P _min )=(V ₂ +V _41max )/(V ₂ +V _41min ); deduce:

It is assumed that all the gas in the gas storage cavity 41 of the end-expiration bag enters the sealed air bag 2 or the sealed bag, that is, V _41min is 0; it is a limit state where the volume of the gas storage cavity 41 of the bag is the smallest, then it is deduced that:

(P _max /P _min ) = [V ₂ +(V _41max -V _41min )]/V ₂ ; derivation:

[(P _max /P _min )×V ₂ ]=[V ₂ +(V _41max -V _41min )]; derive:

[(P _max /P _min )×V ₂ -V ₂ ]=(V _41max -V _41min ); deduce:

(V _41max −V _41min )=[(P _max /P _min )−1]×V ₂ .

In the non-limit state, the (V _41max -V _41min ) will only have a larger volume, so in order to achieve the design effect, the actual implementation needs:

(V _41max −V _41min )≥[(P _max /P _min )−1]×V ₂ .

In normal patients, take the limit values as: V ₂ =20ml, P _max =830mmHg, P _min =760mmHg, and substitute into the above formula:

(V _41max -V _41min )≥[(830/760)-1]×20ml;

(V _41max -V _41min )≥1.85ml;

That is to say, the volume of the bias balance pressure regulating chamber 4 needs to be greater than 1.85ml at least, which is easy to do.

The gas pressure in the area is related to the altitude. The higher the altitude, the lower the gas pressure. The highest altitude inhabited by human beings on the earth is less than 4000 meters, and the air pressure is greater than 460mmHg; the limit values are: V ₂ =20ml, P _max =(460+70)mmHg=530mmHg, P _min =460mmHg, which are substituted into the above formula:

(V _41max -V _41min )≥[(530/460)-1]×20ml;

(V _41max -V _41min )≥3.05ml;

That is to say, the volume of the bias balance pressure regulating chamber 4 needs to be greater than 3.05ml at least, which is also very easy to do.

When the patient needs to enter the hyperbaric oxygen chamber for treatment, the gas pressure of the hyperbaric oxygen chamber is 0.2-0.25MPa, that is, 1520-1900mmHg. Take the limit values, respectively: V ₂ =20ml, P _max =(1900+70)mmHg=1970mmHg, P _min =1900mmHg, substitute into the above formula:

(V _41max -V _41min )≥[(1970/1900)-1]×20ml;

(V _41max -V _41min )≥0.74ml;

The volume of the bias balance pressure regulating chamber 4 needs to be greater than 0.74ml at least, which is also very easy to do. It should only be noted that after entering the hyperbaric oxygen chamber, when the pressure of the oxygen chamber rises, it is necessary to add gas to the sealed air bag 2 or the sealed bag in time to increase the basic gas volume of the sealed air bag 2 or the sealed bag so that the air pressure in the sealed air bag 2 or the sealed bag can adapt to the ambient pressure of the hyperbaric oxygen chamber.

The specific use details of this product are described below:

First, as shown in Figure 6, use a syringe to connect the inflation port 7 of the elastic valve, and discharge the gas in the sealed air bag 2 of the ventilation catheter body 1, so that the sealed air bag 2 or the sealed bag body membrane is closely attached to the ventilation catheter body 1 or the head section of the ventilation catheter, the surface is coated with lubricant, and the intubation stylet is placed, and the ventilation catheter body 1 or the ventilation catheter is molded into a J shape;

Then, as shown in Figure 7, with the help of a laryngoscope, place the head end of the ventilation catheter body 1 into the glottis, pull out the stylet, and place the ventilation catheter body 1 into the airway through the glottis; adjust the depth of the intubation to a suitable level, fix the endotracheal tube with medical tape, connect the tail end of the ventilation catheter body 1 to the breathing circuit, and start implementing mechanical ventilation;

After that, as shown in Figure 8, connect the elastic valve inflation port 7 with a syringe, and fill the sealed air bag 2 of the ventilation catheter body 1 with appropriate gas. The judgment standard is: the moving sealing body 5 moves back and forth in the bias pressure balance pressure regulating chamber 4, and at the same time, the bias elastic body 43 is always in a state of elastic deformation, and the moving sealing body 5 is always exerted on the moving sealing body 5. The force F ₄₃ directed from the ventilation variable pressure chamber 42 to the air storage chamber 41 of the bag. At this time, as shown in A and B in the figure, the bias elastic body 43 is continuously deformed in the same elastic state (compressed or stretched all the time), and the corresponding moving sealing body 5 reciprocates;

At the end of the ventilation, after cleaning up the oral secretions, as shown in Figure 6, discharge the gas in the sealed air bag 2 of the ventilation catheter tube body 1, so that the sealed air bag 2 or the sealed bag body membrane is closely attached to the ventilation catheter body 1 or the head section of the ventilation catheter, and the ventilation catheter body 1 can be pulled out.

Further, as shown in FIG. 9 , the outer wall of the cylindrical cavity marks the scale of the pressure generated by the biasing elastic body 43 on the moving sealing body 5 , and the corresponding side wall of the piston body 51 corresponds to the top of the biasing elastic body 43 to mark the reading identification line.通过筒状腔外壁标记的偏压弹性体43对运动密封体5产生的压强数值刻度，对应活塞体51侧壁标记读数标识线，我们可以观察到机械通气时活塞体51运动范围，从而准确获知机械通气时P ₄₃的波动范围，即获知机械通气时密封气囊2内气体压强P ₂与气道内通气压强P_气道之间的差值，根据病情需求调整密封气囊2内气体含量，从而调整P ₄₃的波动范围，再根据机械通气患者气道压强波动范围，及可获值患者机械通气时密封气囊2对气道粘膜的压迫强度。 That is, the fluctuation range of P ₄₃ is P _43min -P _43max , the fluctuation range of P _airway is P _{airway min} -P _{airway max} , then the pressure fluctuation range of the airbag 2 on the airway mucosa is (P _{airway min} +P _43max ) to P _{airway max} +P _43min ). Such as the patient's airway pressure P _airway is 1mmHg in the expiratory phase, and 12mmHg in the inspiratory phase; the range of motion of the piston body 51 is 2-5mmHg, then the pressure of the sealed airbag 2 to the airway intima in the expiratory phase is (1+5)mmHg=6mmHg, and the pressure in the inspiratory phase is (12+2)mmHg=14mmHg.

Further, as shown in FIG. 10 , the bias pressure balance pressure regulating chamber 4 is provided with an alarm 44, and the cylindrical cavity is provided with alarm contacts 45 on both sides of the moving sealing body 5, and when the moving sealing body 5 touches the alarm contact 45, the alarm 44 is triggered to alarm. By setting alarm contacts 45 at the limit positions on both sides of the moving sealing body 5, when the moving sealing body 5 reciprocates in the cylindrical cavity and touches the limit position, the alarm contacts 45 are triggered, so that the circuit of the alarm 44 is connected, and the alarm 44 alarms. According to the specific information of the alarm, the doctor fills or draws out an appropriate amount of gas in the sealed air bag 2, adjusts the gas content in the sealed air bag 2 to an appropriate level, and the alarm can be automatically released.

In a word, the present invention installs a bias pressure balance regulator, sets a moving sealing body in the bias pressure balancing pressure regulating chamber, isolates the bias pressure balancing pressure regulating chamber into a bag air storage chamber connected with the sealed airbag and a ventilation pressure variable chamber connected with the mechanical ventilation breathing circuit, and then sets a bias elastic body in the bias pressure balance pressure regulating chamber to continuously apply a force F ₄₃ directed from the ventilation variable pressure chamber to the bag gas storage chamber on the moving sealing body. During mechanical ventilation, make the gas pressure P ₄₁ in the gas storage cavity of the bag ≥ the gas pressure P ₄₂ in the ventilation variable pressure cavity. In order to maintain the tightness of mechanical ventilation, the airway mucosa is interrupted to maintain blood circulation during the exhalation phase, so as to avoid compression damage to the airway mucosa.

Claims

A sealing airbag automatic pressure regulating ventilation catheter, including the ventilation duct (1), the ventilation duct (1) the head section is equipped with a sealing airbag (2), which is characterized by: connecting the sealing airbags (2) to set the bias balancing regulator (3), which includes a partial voltage balancing regulator (4) and the movement of the pressure balancing cavity (4). Sealing body (5), the motion sealing body (5) freely moved in the bias balancing 平密 (4), the partial pressure balancing regulatory cavity (4) is separated by the motion seal (5) to be separated from the sealing airbag (2) the air cavity (41) and the ventilation cavity (42) connected to the mechanical ventilation circuit; Plague elastomer (43); During mechanical ventilation, the partial pressure elastomer (43) continues to apply for the motion seal (5) to continuously applies the force Fiting the air cavity (42) to the capillary cavity (41). 43, so that the gas pressure P in the bag gas storage chamber (41) 41≥Gas pressure P in the ventilated variable pressure chamber (42) 42.
An automatic pressure-regulating connection device for a sealed airbag, characterized in that it includes a bias balance regulator (3), the bias balance regulator (3) including a bias balance pressure regulating cavity (4) and a moving sealing body (5) arranged in the bias pressure balancing pressure regulating cavity (4), the moving sealing body (5) is free to move in the bias pressure balancing pressure regulating cavity (4), and the bias pressure balancing pressure regulating cavity (4) is isolated by the moving sealing body (5) into a bag gas storage cavity (41) for communicating with the air duct inflation port ) and a ventilation pressure-changing chamber (42) for communicating with the mechanical ventilation breathing circuit; the bag gas storage chamber (41) is communicated with an inflation fixed interface (9) matching with the ventilation catheter inflation port; Cavity (42) points to the active force F of the bag air storage chamber (41) 43, so that the gas pressure P in the bag gas storage chamber (41) 41≥Gas pressure P in the ventilated variable pressure chamber (42) 42.
According to claim 1 or 2, the sealed air bag automatic pressure-regulating ventilation catheter and its connection device are characterized in that: the effective cross-sectional area of the moving sealing body (5) in the bias-balanced pressure-regulating cavity (4) is S, and the (F 43 ÷ S)≤10mmHg.
According to claim 1 or 2, the sealed airbag automatic pressure-regulating ventilation catheter and connecting device are characterized in that: the bias pressure balance and pressure-regulating chamber (4) is set as a cylindrical cavity, the moving sealing body (5) is set as a piston body (51) matching the cross section of the cylindrical cavity, and the bias elastic body (43) includes a compressed elastic body arranged in the ventilation variable pressure chamber (42) or a stretched elastic body arranged in the air storage chamber (41).
According to claim 1 or 2, the sealed airbag automatic pressure-regulating ventilation catheter and its connection device are characterized in that: the moving sealing body (5) is set as a soft diaphragm (52) that is sealed and connected to the inner wall of the bias pressure balance pressure regulating chamber (4), and the biasing elastic body (43) includes an elastic body that is integrated with the soft diaphragm (52) and protrudes into the air storage cavity (41) of the bag, a compressed elastic body that is arranged in the ventilation variable pressure chamber (42) or stretched and arranged in the air storage chamber (41) of the bag ) within the tensile elastomer.
According to claim 1 or 2, the sealed air bag automatic pressure regulating ventilation catheter and connecting device are characterized in that: an elastic valve inflation port (7) is provided to communicate with the bag air storage chamber (41).
According to claim 1, the sealed airbag automatic pressure-regulating ventilation catheter is characterized in that: the mechanical ventilation breathing circuit includes a ventilation catheter body (1) and a breathing connecting tube (8) whose two ends are respectively matched with the ventilation catheter body (1) and the breathing threaded pipe.
According to claim 1 or 2, the sealed airbag automatic pressure-regulating ventilation catheter and its connection device are characterized in that: the volume of the sealed airbag (2) or the sealed bag of the ventilation catheter is V2 ; the highest gas pressure in the mechanical ventilation breathing circuit is Pmax , and the lowest pressure is Pmin; the maximum volume of the bag gas storage chamber (41) is V41max , and the minimum volume is V41min ; the ( V41max - V41min )≥[(P max /P min )-1]× V 2 .
According to claim 4, the sealed air bag automatic pressure-regulating ventilation catheter and connecting device are characterized in that: the outer wall of the cylindrical cavity marks the scale of the pressure generated by the biasing elastic body (43) on the moving sealing body (5), and the corresponding side wall of the piston body (51) corresponds to the top of the biasing elastic body (43) and marks the reading line.
According to claim 4, the sealed airbag automatic pressure-regulating ventilation catheter and connecting device are characterized in that: the bias pressure balance pressure-regulating cavity (4) is provided with an alarm (44), and the cylindrical cavity is provided with alarm contacts (45) on both sides of the moving sealing body (5), and when the moving sealing body (5) touches the alarm contact (45), the alarm (44) is triggered to alarm.