A respiratory mechanics measuring device, measuring system and measuring method

Abstract

The present invention discloses a respiratory mechanics measuring device, which comprises: an airway pressure sensor, a gas flow sensor, an esophageal pressure sensor and an intragastric pressure sensor; the measuring device is connected to a gastric tube with an esophageal pressure measuring cuff and an intragastric pressure measuring cuff for use; the measuring device is connected to a tracheal catheter for use. Correspondingly, the present invention also provides a respiratory mechanics measuring system and a respiratory mechanics measuring method using the system. The measuring device provided by the present invention is simple and convenient to operate, low in cost, and accurate in monitoring.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a respiratory mechanics measuring device, a measuring system and a measuring method. Background Art

[0002] In the management of critical illness and surgical anesthesia, doctors need to adjust the patient's ventilator settings in a timely manner according to the patient's specific situation. This adjustment depends largely on the respiratory mechanics parameters displayed on the ventilator or anesthesia machine screen, and the measurement of such parameters mainly depends on the respiratory mechanics parameter monitoring module and its related functions that come with the ventilator or anesthesia machine.

[0003] In actual operation, esophageal pressure and intragastric pressure monitoring are particularly important for individualized and precise protective lung ventilation management for anesthetized and critically ill patients. The above pressure measurement can dynamically reflect the pathophysiological state of the patient's respiratory system in real time, guide doctors to adjust the patient's respiratory parameters, optimize the patient's respiratory function, reduce the incidence of lung injury, and improve clinical prognosis.

[0004] However, the respiratory parameter modules that match the common ventilators and anesthesia machines on the market have limited functions, and most of them can only display limited respiratory mechanics parameters. In clinical work in intensive care units and operating rooms, if it is necessary to accurately measure esophageal pressure and intragastric pressure, the department often needs to purchase a complete set of recording instruments (such as Powerlab data acquisition devices), and the related software platform also needs to be built and maintained by a dedicated person, which is not only expensive, but also less convenient. Some other high-end machines have a relatively complete display of respiratory mechanics parameters and are equipped with esophageal pressure and intragastric pressure monitoring function modules. However, this type of high-end ventilator / anesthesia machine is often very expensive (generally up to twice as much as ordinary machines), and its self-contained functional modules cannot be used alone or commonly used in other equipment (can only be used in combination with the original machine). The high cost of use has greatly hindered the clinical implementation and popularization of this monitoring technology, making it impossible for many patients to carry out individualized and accurate mechanical ventilation management.

[0005] In addition, the absolute value of esophageal pressure measurement and its fluctuation accuracy are easily affected by many factors such as the cuff inflation volume and the patient's condition. Therefore, in the clinical application process, it is necessary to first accurately calibrate the optimal inflation value of the esophageal pressure cuff to determine its optimal ventilation value. However, in clinical practice, this process is time-consuming, cumbersome, and difficult to accurately control manually. More importantly, the automatic integration of this function has not been achieved on the current high-end ventilators / anesthesia machines. This further limits the widespread application of esophageal pressure monitoring in clinical practice.

[0006] In summary, existing respiratory mechanics testing equipment is integrated with high-end ventilators / anesthesia machines, which are expensive; large in size and poor in portability; unable to automatically calibrate and adjust the inflation value of the esophageal pressure cuff; inconvenient to operate on the software side and unable to perform real-time data management. Therefore, there is an urgent need for a respiratory mechanics measuring device that is low in cost, simple to operate, precise in control, and can achieve automatic calibration and adjustment. Summary of the invention

[0007] In order to overcome the defects in the prior art, the present invention proposes a device for measuring respiratory mechanics during mechanical ventilation for critically ill and anesthetized patients. The respiratory mechanics measuring device is used to independently and systematically monitor important respiratory mechanics parameters such as esophageal pressure, intragastric pressure, airway pressure, transpulmonary pressure, tidal volume, and circuit gas flow in mechanically ventilated patients, and has the function of automatic and precise regulation of the inflation volume of the esophageal pressure cuff; and the device can be used to guide the individualized and meticulous management of mechanical ventilation in clinical practice.

[0008] According to one aspect of the present invention, there is provided a respiratory mechanics measuring device, the measuring device comprising: an airway pressure sensor, a gas flow sensor, an esophageal pressure sensor and an intragastric pressure sensor;

[0009] The measuring device is connected to a stomach tube with an esophageal pressure measuring cuff and an intragastric pressure measuring cuff for use;

[0010] The measuring device is connected to a breathing circuit (endotracheal tube) for use.

[0011] According to a specific embodiment of the present invention, the measuring device further comprises: a data processing module and / or a display module.

[0012] According to another aspect of the present invention, there is provided a respiratory mechanics measurement system, the measurement system comprising: the respiratory mechanics measurement device according to claim 1, a gastric tube and a breathing circuit (endotracheal tube);

[0013] The stomach tube is equipped with an esophageal manometry cuff and an intragastric manometry cuff;

[0014] The bypass of the breathing circuit is connected to the airway pressure sensor via a hose;

[0015] The main circuit of the breathing circuit is connected to the gas flow sensor via a hose;

[0016] The esophageal pressure measuring cuff is connected to the esophageal pressure sensor via a hose;

[0017] The intragastric pressure measuring cuff is connected to the intragastric pressure sensor via a hose.

[0018] According to another aspect of the present invention, a method for measuring respiratory mechanics is provided, the method comprising the steps of:

[0019] a) inserting a stomach tube and ensuring that the esophageal pressure measuring cuff and the intragastric pressure measuring cuff are in the correct positions;

[0020] b) Determine the optimal inflation value of the esophageal manometry cuff;

[0021] c) starting the measuring device to obtain at least one respiratory mechanics parameter;

[0022] The respiratory mechanics parameters include: esophageal pressure, intragastric pressure, airway pressure, and gas flow;

[0023] The measuring method uses a respiratory mechanics measuring system as claimed in claim 3.

[0024] According to a specific embodiment of the present invention, the esophageal pressure measuring cuff and the intragastric pressure measuring cuff being in the correct position means that the esophageal pressure measuring cuff is located at 2 / 3 of the middle and lower part of the esophagus; and the intragastric pressure measuring cuff is located in the stomach.

[0025] According to another specific embodiment of the present invention, the step a) further comprises:

[0026] Insertion of a gastric tube;

[0027] Injecting 1-10 ml of air into the esophageal pressure measuring cuff and injecting 5-10 ml of air into the intragastric pressure measuring cuff;

[0028] Confirm that the esophageal pressure measuring cuff and the intragastric pressure measuring cuff are in the correct position.

[0029] According to another specific embodiment of the present invention, the step b) further comprises:

[0030] Inflate the esophageal pressure measurement cuff multiple times and record the inflation value;

[0031] The end-inspiratory and end-expiratory esophageal pressures were recorded at each inflation value;

[0032] Draw a curve according to the inflation value and the esophageal pressure at the end of inspiration and the end of expiration;

[0033] Determine a gentle middle section in the curve, the X-axis corresponding to which is the lowest and highest inflation value of the esophageal pressure measurement cuff;

[0034] Between the highest and lowest inflation values, the smaller value of the inflation amount when the difference between the esophageal pressure at the end of inspiration and at the end of expiration is the largest is the optimal inflation value of the esophageal pressure measuring cuff.

[0035] According to another specific embodiment of the present invention, the determination method further comprises the steps of:

[0036] d) Processing the respiratory mechanics parameters to generate relevant numerical values ​​and / or graphs.

[0037] According to another specific embodiment of the present invention, the determination method further comprises the steps of:

[0038] e) Displaying the respiratory mechanics parameters, related values ​​and / or graphs.

[0039] According to another specific embodiment of the present invention, the determination method further comprises the steps of:

[0040] f) generating a .csv file package of the respiratory mechanics parameters, related values ​​and / or charts.

[0041] The respiratory mechanics measuring device, system and method provided by the present invention innovatively integrate the esophageal pressure and intragastric pressure detection into an independent portable device, breaking the current technical barriers of major manufacturers and facilitating clinical popularization and application. The cuff inflation value of the esophageal pressure monitoring is innovatively monitored in real time and dynamically adjusted. The monitoring is accurate. The use of this measuring device, system and method can achieve high-precision measurement of esophageal pressure, intragastric pressure and airway pressure, with an accuracy of up to 0.01cmH2O, which is unattainable by current anesthesia machines and ventilators. This set of measuring devices and systems has low manufacturing costs and good durability; it is simple to operate and easy to achieve personalized management of mechanical ventilation. BRIEF DESCRIPTION OF THE DRAWINGS

[0042] Other features, objects and advantages of the present invention will become more apparent from the detailed description of non-limiting embodiments made with reference to the following drawings:

[0043] Figure 1 It is a structural schematic diagram of a specific embodiment of a respiratory mechanics measuring device provided by the present invention;

[0044] Figure 2 Shown is a schematic diagram of a specific embodiment of a display module;

[0045] Figure 3 It is a schematic flow chart of a specific embodiment of a respiratory mechanics measurement method provided by the present invention;

[0046] Figure 4 It is a schematic flow chart of another specific embodiment of a respiratory mechanics measurement method provided by the present invention;

[0047] Figure 5 Shown is a schematic diagram of the correct position of the gastric tube;

[0048] Figure 6 Shown is a graph of esophageal pressure and inflation value.

[0049] The same or similar reference numerals in the drawings represent the same or similar components. DETAILED DESCRIPTION

[0050] The disclosure below provides many different embodiments or examples for realizing different structures of the present invention. In order to simplify the disclosure of the present invention, the components and settings of specific examples are described below. In addition, the present invention may repeat reference numbers and / or letters in different examples. This repetition is for the purpose of simplification and clarity, and does not itself indicate the relationship between the various embodiments and / or settings discussed. It should be noted that the components illustrated in the accompanying drawings are not necessarily drawn to scale. The present invention omits the description of known components and processing techniques and processes to avoid unnecessary limitations on the present invention.

[0051] See also Figure 1 The present invention provides a respiratory mechanics measuring device, which comprises: an airway pressure sensor 10, a gas flow sensor 20, an esophageal pressure sensor 30 and an intragastric pressure sensor 40. The measuring device is connected to a gastric tube with an esophageal pressure measuring cuff and an intragastric pressure measuring cuff for use; the measuring device is connected to a tracheal tube for use.

[0052] Preferably, the measuring device further comprises a data processing module 50 for integrating and processing the data acquired by the above-mentioned sensors.

[0053] Preferably, the measuring device further includes a storage device 80, which is used to store the data acquired by the sensor and the data processed by the data processing module 50. More preferably, the storage device 80 can be hardware installed integrally with the measuring device, such as an SD card, a hard disk, etc., or a mobile storage device, a cloud storage device, etc.

[0054] Preferably, the measuring device includes a communication module 70, and the communication module 70 is used to communicate with other modules, devices, etc. For example, the communication module 70 can be used to transmit the data acquired by the sensor to a cloud storage device, or to a display device. The communication module 70 can be, for example, Bluetooth, wifi, 5G, etc.

[0055] Preferably, the measuring device further includes a display module 60. The measuring device can be used in conjunction with other display devices, that is, the data to be displayed is sent to the display device through the communication module 70. However, for greater convenience, the measuring device can be equipped with a display module 60 to directly display the data to be displayed, thereby increasing the convenience of use. Figure 2 That is a schematic diagram of a specific implementation of the display module 60.

[0056] It can be understood that, for normal use of the measuring device, the measuring device also includes an air pump 90 and a power supply 100 .

[0057] The respiratory mechanics measuring device provided by the present invention can be used in conjunction with a gastric tube and a breathing circuit that meet certain requirements. However, for the sake of convenience and higher accuracy, the present invention also provides a respiratory mechanics measuring system including a gastric tube, a tracheal catheter and the above respiratory mechanics measuring device. The gastric tube is equipped with an esophageal pressure measuring cuff and an intragastric pressure measuring cuff; the bypass of the breathing circuit is connected to the airway pressure sensor through a hose; the main line of the breathing circuit is connected to the gas flow sensor through a hose; the esophageal pressure measuring cuff is connected to the esophageal pressure sensor through a hose; and the intragastric pressure measuring cuff is connected to the intragastric pressure sensor through a hose.

[0058] Figure 3 The figure shows a method for measuring respiratory mechanics using the respiratory mechanics measuring system provided by the present invention.

[0059] Step S101, inserting a gastric tube, and confirming that the esophageal pressure measuring cuff and the intragastric pressure measuring cuff are in the correct position. The esophageal pressure measuring cuff and the intragastric pressure measuring cuff are in the correct position means that: the esophageal pressure measuring cuff is located at 2 / 3 of the middle and lower part of the esophagus; the intragastric pressure measuring cuff is located in the stomach, such as Figure 5 shown.

[0060] Furthermore, the step S101 includes:

[0061] Insertion of a gastric tube;

[0062] Inject 1-10 ml of air into the esophageal pressure measuring cuff, such as 1 ml, 5 ml or 10 ml; inject 5-10 ml of air into the gastric pressure measuring cuff, such as 5 ml, 7 ml or 10 ml;

[0063] Confirm that the esophageal pressure measuring cuff and the intragastric pressure measuring cuff are in the correct position.

[0064] The process continues with step S102 to determine the optimal inflation volume of the esophageal pressure measuring cuff.

[0065] First, the esophageal pressure cuff is inflated several times and the inflation value is recorded. Inflation starts from 0.5 ml, and inflates once every 0.5 ml until it reaches 8.0 ml. It is worth noting that in order to ensure the accuracy of inflation, it is necessary to completely deflate before each inflation.

[0066] At each inflation value, the corresponding esophageal pressure (Pes) at the end of inspiration and expiration was recorded.

[0067] A curve is drawn according to the inflation value and the esophageal pressure at the end of inspiration and the end of expiration, such as Figure 6 As shown in Figure 1, the inflation value is the horizontal axis and the esophageal pressure is the vertical axis.

[0068] A gentle middle section is determined in the curve, and the corresponding X-axis is the lowest and highest inflation value of the esophageal pressure measurement cuff. Figure 6 As shown in the figure, the minimum inflation value of the esophageal pressure measurement cuff is 1 ml, and the maximum inflation value is 5 ml.

[0069] Between the highest and lowest inflation values, the smaller value of the inflation volume when the difference between the esophageal pressure at the end of inspiration and at the end of expiration is the largest is the optimal inflation value of the esophageal pressure measuring cuff, 2 ml.

[0070] After determining the optimal inflation value, the esophageal pressure cuff is completely deflated, and then the optimal inflation value is injected into the cuff, and step S103 is executed to start the measuring device to obtain at least one respiratory mechanics parameter. The respiratory mechanics parameters include but are not limited to: esophageal pressure, intragastric pressure, airway pressure, and gas flow.

[0071] See also Figure 4 , the determination method further comprises the steps of:

[0072] S104, processing the respiratory mechanics parameters to generate relevant numerical values ​​and / or graphs.

[0073] S105, displaying the respiratory mechanics parameters, related values ​​and / or charts, as shown in the following table:

[0074]

[0075] S106, generating a .csv file package from the respiratory mechanics parameters, related values ​​and / or charts, which can be downloaded, exported and used for data backtracking.

[0076] For ease of understanding, the technical solution claimed in the present invention is generally described below by taking a practical application as an example.

[0077] The patient was diagnosed with gallstones and cholecystitis and was planned to undergo laparoscopic cholecystectomy under general anesthesia.

[0078] Before the operation, after the patient enters the operating room, he / she is connected to conventional monitoring equipment such as ECG monitoring, blood pressure monitoring, and blood oxygen saturation monitoring. At the same time, a gastric tube with an esophageal pressure cuff and an intragastric pressure cuff is inserted into the patient's stomach through the nose to ensure that the esophageal pressure cuff is located in the middle and lower 2 / 3 of the esophagus and the intragastric pressure cuff is located in the stomach. Then anesthesia induction begins, a tracheal tube is inserted, and the anesthesia machine is connected for mechanical ventilation and surgical treatment.

[0079] During the operation, the measuring device, gastric tube and breathing circuit are properly connected (if the measuring system provided by the present invention is used, the internal connection of the measuring system is ensured to be normal). Determine the optimal inflation value of the esophageal pressure cuff. Under the optimal inflation value, obtain the patient's current comprehensive respiratory mechanics parameters to guide the anesthesiologist in individualized and precise respiratory management. The above respiratory mechanics parameters are recorded in real time and a .csv data file is generated for retrospective and scientific research purposes.

[0080] After the operation, the measurement device or the measurement system may be disconnected.

[0081] The technical solution claimed in the present invention can realize independent monitoring, automatic correction and adjustment of respiratory parameters such as esophageal pressure and airway pressure, and has simple operation, low cost and is easy to promote and use on a large scale.

[0082] Although the exemplary embodiments and their advantages have been described in detail, it should be understood that various changes, substitutions and modifications may be made to these embodiments without departing from the spirit of the present invention and the scope of protection defined by the appended claims. For other examples, it should be readily understood by those skilled in the art that the order of the process steps may be changed while maintaining the scope of protection of the present invention.

[0083] In addition, the scope of application of the present invention is not limited to the processes, mechanisms, manufactures, material compositions, means, methods and steps of the specific embodiments described in the specification. From the disclosure of the present invention, it will be easily understood by those skilled in the art that the processes, mechanisms, manufactures, material compositions, means, methods or steps that currently exist or will be developed in the future, which perform substantially the same functions as the corresponding embodiments described in the present invention or obtain substantially the same results, can be applied according to the present invention. Therefore, the claims attached to the present invention are intended to include these processes, mechanisms, manufactures, material compositions, means, methods or steps within their scope of protection.

Claims

1. A respiratory mechanics measuring device, characterized in that: The measuring device comprises: an airway pressure sensor, a gas flow sensor, an esophageal pressure sensor and an intragastric pressure sensor; The measuring device is connected to a stomach tube with an esophageal pressure measuring cuff and an intragastric pressure measuring cuff for use; The measuring device is connected to a tracheal tube for use. During the measuring process, the optimal inflation value of the esophageal pressure measuring cuff is first determined, specifically including: inflating the esophageal pressure measuring cuff multiple times and recording the inflation value; The end-inspiratory and end-expiratory esophageal pressures were recorded at each inflation value; Draw a curve according to the inflation value and the esophageal pressure at the end of inspiration and the end of expiration; Determine a gentle middle section in the curve, the X-axis corresponding to which is the lowest and highest inflation value of the esophageal pressure measurement cuff; Between the highest and lowest inflation values, the smaller value of the inflation volume when the difference between the esophageal pressure at the end of inspiration and at the end of expiration is the largest is the optimal inflation value of the esophageal pressure measurement cuff. Then the measuring device is started to obtain at least one respiratory mechanics parameter.

2. The measuring device according to claim 1, characterized in that The measuring device further comprises: a data processing module and / or a display module.

3. A respiratory mechanics measurement system, characterized in that: The measuring system comprises: the respiratory mechanics measuring device as claimed in claim 1, a gastric tube and a tracheal tube; The stomach tube is equipped with an esophageal manometry cuff and an intragastric manometry cuff; The bypass of the breathing circuit is connected to the airway pressure sensor via a hose; The main circuit of the breathing circuit is connected to the gas flow sensor via a hose; The esophageal pressure measuring cuff is connected to the esophageal pressure sensor via a hose; The intragastric pressure measuring cuff is connected to the intragastric pressure sensor via a hose.

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