Respiratory mechanics measuring device, measuring system and measuring method
Technical Field
The invention relates to the technical field of medical equipment, in particular to a respiratory mechanics measuring device, a measuring system and a measuring method.
Background
In the management of critical illness and surgical anesthesia, a doctor needs to adjust the breathing machine setting parameters of a patient in time according to the specific condition of the patient. Such adjustments are largely dependent on the respiratory mechanics parameters displayed on the screen of the ventilator or anesthesia machine, and the determination of such parameters is largely dependent on the ventilator or anesthesia machine's own respiratory mechanics parameter monitoring module and its associated functions.
In the actual operation process, esophageal pressure and intragastric pressure monitoring is particularly important for individual precise protective pulmonary ventilation management of patients suffering from anesthesia and respiratory distress. The pressure measurement can dynamically reflect the pathophysiological state of the respiratory system of the patient in real time, guide doctors to adjust the respiratory parameters of the patient, optimize the respiratory function of the patient, reduce the incidence rate of lung injury of the patient and improve the clinical prognosis.
However, the breathing parameter modules matched with the conventional respirators and anesthesia machines on the market at present have limited functions, and most of the breathing parameter modules can only display limited breathing mechanical parameters. In clinical work in a guardianship room and an operating room, if the esophageal pressure and the gastric internal pressure are required to be accurately measured, a complete set of recording instrument (such as Powerlab data acquisition device) is often required to be purchased in the department, and a software platform related to the complete set of recording instrument is also required to be built and maintained by special persons, so that the cost is high, and the convenience is poor. Some high-end machines are provided with complete respiratory mechanics parameter display and are provided with esophageal pressure and intragastric pressure monitoring function modules. However, such high-end ventilators/anesthesiologists tend to be very expensive (typically as much as twice as many as conventional machines), and their self-contained functional modules cannot be used alone or in common with other devices (only in a bundle with the original machine). The use cost is too high to greatly prevent the clinical implementation and popularization application of the monitoring technology, so that many patients cannot perform individualized and accurate mechanical ventilation management.
In addition, the absolute value and the fluctuation accuracy of the esophageal manometry are easily affected by various factors such as the inflation quantity of the cuff, the condition of a patient and the like. Therefore, in the clinical application process, the optimal inflation value of the esophagus pressure cuff needs to be precisely calibrated first, and the optimal inflation value is determined. However, the process is long in clinical time consumption, complicated in procedure and difficult to accurately control by manual operation. More importantly, the integration of this functional automation is not realized on the existing high-end ventilator/anesthesia machine. This further limits the wide clinical use of esophageal pressure monitoring.
In summary, the existing respiratory mechanics detection equipment is integrated with a high-end respirator/anesthesia machine in a binding way, is high in price, large in size and poor in portability, cannot automatically calibrate and adjust the inflation value of the esophageal pressure cuff, and cannot perform real-time data management due to inconvenient software end operation. Therefore, a respiratory mechanics measuring device with low use cost, simple operation, accurate control and automatic calibration and adjustment is urgently needed at present.
Disclosure of Invention
In order to overcome the defects in the prior art, the invention provides a device for measuring respiratory mechanics in the mechanical ventilation process of patients with critical symptoms and anesthesia operation. The respiratory mechanics measuring device is used for independently and systematically monitoring important respiratory mechanics parameters such as esophageal pressure, gastric internal pressure, airway pressure, cross-lung pressure, tidal volume, loop gas flow and the like of a mechanically ventilated patient, has an automatic and accurate regulation and control function of esophageal pressure cuff inflation volume, and can be used for guiding the clinic to carry out individual fine management of mechanical ventilation.
According to one aspect of the present invention, there is provided a respiratory mechanics measuring device comprising an airway pressure sensor, a gas flow sensor, an esophageal pressure sensor, and an intragastric pressure sensor;
The measuring device is connected with a stomach tube with an esophagus pressure measuring cuff and an intragastric pressure measuring cuff;
the measuring device is connected with a breathing circuit (an endotracheal tube) for use.
According to one embodiment of the invention, the measuring device further comprises a data processing module and/or a display module.
According to another aspect of the present invention, there is provided a respiratory mechanics measuring system comprising a respiratory mechanics measuring device as claimed in claim 1, a gastric tube and a respiratory circuit (tracheal tube);
the stomach tube is provided with an esophagus pressure measuring cuff and an intragastric pressure measuring cuff;
the bypass of the breathing circuit is connected with the airway pressure sensor through a hose;
the main circuit of the breathing circuit is connected with the gas flow sensor through a hose;
The esophageal pressure measuring cuff is connected with the esophageal pressure sensor through a hose;
the intragastric pressure measuring cuff is connected with the intragastric pressure sensor through a hose.
According to yet another aspect of the present invention, there is provided a method of determining respiratory mechanics, the method comprising the steps of:
a) Placing a stomach tube, and determining that the esophagus pressure measuring cuff and the intragastric pressure measuring cuff are at correct positions;
b) Determining an optimal inflation value of the esophageal pressure cuff;
c) Starting the measuring device to acquire at least one respiratory mechanics parameter;
the respiratory mechanics parameters comprise esophagus pressure, stomach internal pressure, airway pressure and gas flow;
the assay method using a respiratory mechanics assay system according to claim 3.
According to one embodiment of the invention, the esophageal pressure cuff and the intragastric pressure cuff are in the correct position, meaning that the esophageal pressure cuff is located at the lower middle section of the esophagus and the intragastric pressure cuff is located in the stomach.
According to another embodiment of the present invention, the step a) is further:
placing a stomach tube;
1-10ml of air is injected into the esophageal pressure measuring cuff, and 5-10ml of air is injected into the intragastric pressure measuring cuff;
And confirming that the esophageal pressure measuring cuff and the intragastric pressure measuring cuff are in correct positions.
According to a further embodiment of the invention, said step b) is further:
inflating the esophageal pressure measuring cuff for a plurality of times, and recording inflation values;
recording the esophageal pressure at the end of inspiration and end of expiration at each inflation value;
Drawing a curve according to the inflation value and the esophageal pressure of the end inspiration and the end expiration;
determining a gentle middle section in the curve, wherein the X axis corresponding to the gentle middle section is the lowest inflation value and the highest inflation value of the esophageal pressure measuring cuff;
The smaller value of the inflation amount when the end inspiration and end expiration esophageal pressures differ the most between the highest and lowest inflation values is the optimal inflation value of the esophageal pressure cuff.
According to yet another embodiment of the invention, the assay method further comprises the steps of:
d) And processing the respiratory mechanics parameters to generate related numerical values and/or charts.
According to yet another embodiment of the invention, the assay method further comprises the steps of:
e) The respiratory mechanics parameters, related values and/or graphs are displayed.
According to yet another embodiment of the invention, the assay method further comprises the steps of:
f) Generating the respiratory mechanics parameters, related values and/or graphs.
The respiratory mechanics measuring device, the respiratory mechanics measuring system and the respiratory mechanics measuring method provided by the invention innovatively and independently enable esophageal pressure and intragastric pressure detection to be portable equipment, break through the technical barriers of various large factories at present, and are convenient for clinical popularization and application. The cuff inflation value monitored by the esophageal pressure is innovatively monitored in real time, and is dynamically adjusted. The monitoring is accurate, the high-precision measurement of the esophageal pressure, the intragastric pressure and the airway pressure can be realized by adopting the measuring device, the system and the method, and the accuracy rate can reach 0.01cm H 2 O, which cannot be achieved by the existing anesthesia machine and breathing machine. The set of measuring device and the system have low manufacturing cost, good durability, simple operation and easy realization of personalized management of mechanical ventilation.
Drawings
Other features, objects and advantages of the present invention will become more apparent upon reading of the detailed description of non-limiting embodiments, made with reference to the accompanying drawings in which:
FIG. 1 is a schematic view showing the structure of an embodiment of a respiratory mechanics measuring device according to the present invention;
FIG. 2 is a schematic diagram of one embodiment of a display module;
FIG. 3 is a schematic flow chart of one embodiment of a method for determining respiratory mechanics according to the present invention;
FIG. 4 is a schematic flow chart of another embodiment of a method for determining respiratory mechanics according to the present invention;
FIG. 5 is a schematic view of the correct position of the gastric tube;
FIG. 6 is a graph showing esophageal pressure versus inflation value.
The same or similar reference numbers in the drawings refer to the same or similar parts.
Detailed Description
The following disclosure provides many different embodiments, or examples, for implementing different structures of the invention. In order to simplify the present disclosure, components and arrangements of specific examples are described below. Furthermore, the present invention may repeat reference numerals and/or letters in the various examples. This repetition is for the purpose of simplicity and clarity and does not in itself dictate a relationship between the various embodiments and/or configurations discussed. It should be noted that the components illustrated in the figures are not necessarily drawn to scale. Descriptions of well-known components and processing techniques and processes are omitted so as to not unnecessarily obscure the present invention.
Referring to fig. 1, the present invention provides a respiratory mechanics measuring device comprising 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 with a stomach tube with an esophagus pressure measuring cuff and an stomach internal pressure measuring cuff, and is connected with an endotracheal tube.
Preferably, the measuring device further comprises a data processing module 50 for integrating the data acquired by the sensors.
Preferably, the measuring device further comprises a storage device 80, and the storage device 80 is used for storing the data acquired by the sensor and the data processed by the data processing module 50. More preferably, the storage device 80 may be hardware integrally installed with the measurement device, such as an SD card, a hard disk, or a mobile memory, a cloud memory, or the like.
Preferably, the measuring device includes a communication module 70, and the communication module 70 is used for communication connection with other modules, devices, and the like. For example, the communication module 70 may be configured to transmit data acquired by the sensor to a cloud storage or to a display device. The communication module 70 may be, for example, bluetooth, wifi, 5G, etc
Preferably, the assay device further comprises a display module 60. The measuring device can be matched with other display equipment for use, namely, data to be displayed is sent to the display equipment through the communication module 70. However, for convenience, the display module 60 may be provided in the measuring device to directly display the data to be displayed, thereby increasing convenience in use. Fig. 2 is a schematic diagram of one embodiment of a display module 60.
It will be appreciated that for normal use of the assay device, the assay device also includes an air pump 90 and a power supply 100.
The respiratory mechanics measuring device provided by the invention can be matched with a stomach tube and a respiratory circuit meeting certain requirements for use, but in order to be convenient and fast to use, the invention also provides a respiratory mechanics measuring system comprising the stomach tube, the tracheal catheter and the upper respiratory mechanics measuring device. The stomach tube is provided with an esophagus pressure measuring cuff and an intragastric pressure measuring cuff, a bypass of the breathing circuit is connected with the airway pressure sensor through a hose, a trunk of the breathing circuit is connected with the gas flow sensor through a hose, the esophagus pressure measuring cuff is connected with the esophagus pressure sensor through a hose, and the intragastric pressure measuring cuff is connected with the intragastric pressure sensor through a hose.
Fig. 3 shows a measurement method for respiratory mechanics measurement by using the respiratory mechanics measurement system provided by the invention.
Step S101, a stomach tube is placed, and the esophagus pressure measuring cuff and the stomach pressure measuring cuff are determined to be in correct positions. The esophageal pressure cuff and the intragastric pressure cuff being in the correct positions means that the esophageal pressure cuff is located at the lower middle section of the esophagus 2/3 and the intragastric pressure cuff is located in the stomach as shown in fig. 5.
Further, the step S101 includes:
placing a stomach tube;
injecting 1-10ml of air, such as 1ml, 5ml or 10ml, into said esophageal pressure cuff, and injecting 5-10ml of air, such as 5ml, 7ml or 10ml, into said intragastric pressure cuff;
And confirming that the esophageal pressure measuring cuff and the intragastric pressure measuring cuff are in correct positions.
Continuing with step S102, an optimal inflation value for the esophageal pressure cuff is determined.
First, the esophageal pressure cuff is inflated multiple times and the inflation value is recorded. Aeration was started from 0.5ml, and was performed at intervals of 0.5ml, up to 8.0ml. Notably, to ensure the accuracy of inflation, a thorough deflation is required prior to each inflation.
At each inflation value, the esophageal pressure (Pes) at the end of inspiration and end of expiration corresponding thereto is recorded.
And drawing a curve according to the inflation value and the esophageal pressure of the end inspiration and the end expiration, as shown in fig. 6. Wherein, the inflation value is the horizontal axis, and the esophageal pressure is the vertical axis.
A gentle middle segment is defined in the curve, corresponding to the X-axis being the lowest and highest inflation values of the esophageal pressure cuff. Take the example shown in FIG. 6, wherein the lowest inflation value of the esophageal pressure cuff is 1ml and the highest inflation value is 5ml.
The smaller value of the inflated volume when the end inspiration and end expiration esophageal pressures differ the most between the highest and lowest inflated values is the optimal inflated value of the esophageal pressure cuff, 2ml.
After the optimal inflation value is determined, the esophageal pressure cuff is completely deflated, and then the optimal inflation value is injected into the cuff, so that step S103 can be executed, and the measuring device is started 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.
Referring to fig. 4, the assay method further comprises the steps of:
S104, processing the respiratory mechanics parameters to generate related numerical values and/or charts.
S105, displaying the respiratory mechanics parameters, the related values and/or the graphs, wherein the table is shown as follows:
S106, generating the respiratory mechanics parameters, the related values and/or the graphs into a csv file package, the package is available for download exporting and data backtracking.
In order to facilitate understanding, the following description will generally explain the technical solution of the present invention by taking a practical application as an example.
The patient was diagnosed with cholecystolithiasis with cholecystitis, and was scheduled for general anesthesia downlink laparoscopic cholecystectomy.
Before operation, after the patient enters the operating room, connecting with conventional monitoring equipment such as electrocardio monitoring, blood pressure monitoring, blood oxygen saturation monitoring and the like, and simultaneously placing a stomach tube with an esophageal pressure measuring cuff and an intragastric pressure measuring cuff into the stomach of the patient through the nose to ensure that the esophageal pressure measuring cuff is positioned at the middle lower section 2/3 of the esophagus and the intragastric pressure measuring cuff is positioned in the stomach. And then starting anesthesia induction, inserting an endotracheal tube, and connecting an anesthesia machine for mechanical ventilation and surgical treatment.
In operation, the measuring device, the stomach tube and the breathing circuit are properly connected (if the measuring system provided by the invention is adopted, the normal connection inside the measuring system is ensured). An optimal inflation value of the esophageal pressure cuff is determined. And acquiring the current comprehensive respiratory mechanics parameters of the patient under the optimal inflation value, and guiding the anesthesiologist to individually and accurately manage the respiration. And recording the respiratory mechanics parameters in real time to generate a csv data file for backtracking and scientific research.
After the operation, the connection of the measuring device or the measuring system is released.
The technical scheme of the invention can realize independent monitoring, automatic correction and adjustment of respiratory parameters such as esophageal pressure, airway pressure and the like, has simple operation and low cost, and is easy to popularize and use on a large scale.
Although the exemplary embodiments and their advantages have been described in detail, it should be understood that various changes, substitutions and alterations can be made herein without departing from the spirit of the invention and the scope of the invention as defined by the appended claims. For other examples, one of ordinary skill in the art will readily appreciate that the order of the process steps may be varied while remaining within the scope of the present invention.
Furthermore, the scope of the present application is not intended to be limited to the particular embodiments of the process, machine, manufacture, composition of matter, means, methods and steps described in the specification. From the present disclosure, it will be readily understood by those of ordinary skill in the art that processes, machines, manufacture, compositions of matter, means, methods, or steps, presently existing or later to be developed that perform substantially the same function or achieve substantially the same result as the corresponding embodiments described herein may be utilized according to the present disclosure. Accordingly, the appended claims are intended to include within their scope such processes, machines, manufacture, compositions of matter, means, methods, or steps.