Methods for monitoring ventilation leaks in medical ventilation equipment and medical ventilation equipment

Abstract

A method for monitoring ventilation leaks in a medical ventilation device and the medical ventilation device itself are disclosed. The medical ventilation device is configured with a unique intentional leak pressure-flow correspondence to correspond to various types of interface accessories that can be worn on the breathing area of ​​the ventilated individual. The method includes: acquiring a flow signal collected by a flow sensor of the medical ventilation device and determining the total leakage based on the flow signal; acquiring a pressure signal collected by a pressure sensor of the medical ventilation device; invoking the unique intentional leak pressure-flow correspondence and determining the intentional leakage of the interface accessory based on the pressure signal and the pressure-flow correspondence; and determining the unintentional leakage of the interface accessory based on the difference between the total leakage and the intentional leakage. This application achieves automatic monitoring of unintentional leaks without requiring the user to select an applicable pressure-flow correspondence.

Description

[0001] Divisional application information This invention patent application is a divisional application of the invention patent application filed on November 2, 2022, with application number 202211363905.6, and entitled "Method for Monitoring Ventilation Leakage of Medical Ventilation Equipment and Medical Ventilation Equipment". Technical Field

[0002] This application relates to the field of medical devices, and more specifically to a method for monitoring ventilation leaks in medical ventilation devices and the medical ventilation devices themselves. Background Technology

[0003] Non-invasive ventilators are widely used for patients with mild respiratory failure who still have spontaneous breathing due to their ease of operation, patient acceptance, and lower risk of secondary lung injury and infection. Non-invasive ventilation does not require the establishment of an artificial airway; instead, it delivers air to the patient through interfaces such as masks and nasal masks. Most non-invasive ventilators are not equipped with active expiratory valves. Ideally, all leaked gas overflows through the mask's ventilator or passive expiratory valve. This leakage facilitates the patient's exhaled carbon dioxide expulsion and is considered an intentional leak necessary for normal ventilation. However, in actual use, the interface between the device and the patient cannot be completely sealed, and some gas may leak out at the contact surface, which is considered an unintentional leak. If the interface accessory is worn too loosely, a large amount of gas will leak from the contact surface between the patient's face and the accessory. Excessive leakage can easily cause accidental triggering. Combined with the patient's breathing efforts, this can easily lead to adverse events such as double triggering, insufficient inspiratory flow, invalid triggering, and premature / delayed switching, reducing patient-ventilator synchrony and ventilation stability. In severe cases, it can even cause abnormal respiratory cycles. Therefore, unintentional leakage should not be too large. If the interface accessory is worn too tightly, it will increase the pressure on the patient and easily cause facial injury. Therefore, unintentional leakage should not be too small. Therefore, monitoring unintentional leakage can help doctors determine the tightness of the interface accessory in the interaction with the patient. Summary of the Invention

[0004] The summary section introduces a series of simplified concepts, which will be further explained in detail in the detailed description section. This summary section is not intended to limit the key and essential technical features of the claimed technical solution, nor is it intended to determine the scope of protection of the claimed technical solution.

[0005] A first aspect of this application provides a method for monitoring ventilation leakage in a medical ventilation device. The medical ventilation device includes a pressure generating device, a pressure sensor, a flow sensor, and a processor. The pressure generating device is connected to a ventilation tubing, which is connected to an interface accessory worn on the breathing area of ​​a person being ventilated, to deliver gas at a set pressure or flow rate to the person being ventilated through the ventilation tubing and the interface accessory. The processor controls the pressure generating device to generate the gas at the set pressure or flow rate. The medical ventilation device is configured with a unique intentional leakage pressure-flow rate correspondence to various types of interface accessories that can be worn on the breathing area of ​​the person being ventilated. The method includes: acquiring a flow rate signal collected by the flow sensor and obtaining a total leakage based on the flow rate signal; acquiring a pressure signal collected by the pressure sensor; the processor calling the uniquely configured intentional leakage pressure-flow rate correspondence of the interface accessory and obtaining an intentional leakage of the interface accessory worn on the breathing area of ​​the person being ventilated based on the pressure signal and the uniquely configured intentional leakage pressure-flow rate correspondence of the interface accessory; and the processor obtaining an unintentional leakage of the interface accessory based on the difference between the total leakage and the intentional leakage of the interface accessory.

[0006] In some embodiments, the intentional leakage pressure-flow correspondence of the uniquely configured interface accessory is obtained based on pressure data and intentional leakage flow data of at least one interface accessory, and is pre-configured in the medical ventilation device.

[0007] In some embodiments, the pressure-flow correspondence of the intentionally leaked uniquely configured interface accessory is obtained by fitting at least two sets of pressure data and the intentionally leaked flow data of the interface accessory; or, the pressure-flow correspondence of the intentionally leaked uniquely configured interface accessory is obtained by averaging at least two sets of pressure data and the intentionally leaked flow data of the interface accessory.

[0008] In some embodiments, the intentionally leaked pressure-flow correspondence of the uniquely configured interface accessory is obtained by piecewise fitting within at least two pressure ranges.

[0009] In some embodiments, the intentionally leaked pressure-flow correspondence of the uniquely configured interface accessory is obtained by polynomial fitting.

[0010] In some embodiments, the intentionally leaked pressure-flow correspondence of the uniquely configured interface accessory is selected from pressure-flow correspondences of at least two interface accessories and pre-configured in the medical ventilation device.

[0011] In some embodiments, the pressure sensor is located at the interface accessory or at the device end of the medical ventilation device.

[0012] In some embodiments, obtaining the total leakage based on the flow signal includes obtaining the average flow rate of the total leakage based on the flow signal; obtaining the intentional leakage of the interface accessory worn by the breathing part of the ventilated object based on the pressure signal and the pressure-flow correspondence of the intentional leakage of the uniquely configured interface accessory includes obtaining the average flow rate of the intentional leakage of the interface accessory based on the pressure signal and the pressure-flow correspondence of the intentional leakage of the uniquely configured interface accessory; obtaining the unintentional leakage of the interface accessory based on the difference between the total leakage and the intentional leakage of the interface accessory includes obtaining the average flow rate of the unintentional leakage of the interface accessory based on the difference between the average flow rate of the total leakage and the average flow rate of the intentional leakage of the interface accessory, and using this as the unintentional leakage of the interface accessory.

[0013] In some embodiments, obtaining the total leakage based on the flow signal includes: filtering the flow signal to obtain the average flow rate of the total leakage as the total leakage, wherein the filtering includes low-pass filtering or adaptive filtering.

[0014] In some embodiments, obtaining the total leakage based on the flow signal includes: extracting flow data for at least one respiratory cycle from the flow signal; and obtaining the average flow rate of the total leakage based on the average value of the flow data for the at least one respiratory cycle, as the total leakage.

[0015] In some embodiments, obtaining the average flow rate of the intentional leakage of the interface accessory based on the pressure signal and the pressure-flow correspondence of the intentional leakage of the uniquely configured interface accessory includes: filtering the pressure signal to obtain an average pressure, the filtering including low-pass filtering or adaptive filtering; and obtaining the average flow rate of the intentional leakage of the interface accessory according to the average pressure and the pressure-flow correspondence of the intentional leakage of the uniquely configured interface accessory.

[0016] In some embodiments, obtaining the average flow rate of the intentional leakage of the interface accessory based on the pressure signal and the pressure-flow correspondence of the intentional leakage of the uniquely configured interface accessory includes: extracting pressure data of at least one respiratory cycle from the pressure signal; obtaining an average pressure based on the average value of the pressure data of the at least one respiratory cycle; and obtaining the average flow rate of the intentional leakage of the interface accessory based on the average pressure and the pressure-flow correspondence of the intentional leakage of the uniquely configured interface accessory.

[0017] In some embodiments, obtaining the average flow rate of the intentional leakage of the interface accessory based on the pressure signal and the pressure-flow correspondence of the intentional leakage of the uniquely configured interface accessory includes: obtaining the instantaneous flow rate signal of the intentional leakage of the interface accessory according to the pressure signal and the pressure-flow correspondence of the intentional leakage of the uniquely configured interface accessory; filtering the instantaneous flow rate signal of the intentional leakage of the interface accessory to obtain the average flow rate of the intentional leakage of the interface accessory, wherein the filtering includes low-pass filtering or adaptive filtering.

[0018] In some embodiments, obtaining the average flow rate of the intentional leakage of the interface accessory based on the pressure signal and the pressure-flow correspondence of the intentional leakage of the uniquely configured interface accessory includes: obtaining an instantaneous flow rate signal of the intentional leakage of the interface accessory based on the pressure signal and the pressure-flow correspondence of the intentional leakage of the uniquely configured interface accessory; extracting instantaneous flow rate data of at least one respiratory cycle from the instantaneous flow rate signal of the intentional leakage of the interface accessory; and obtaining the average flow rate of the intentional leakage of the interface accessory based on the average value of the instantaneous flow rate data of at least one respiratory cycle extracted from the instantaneous flow rate signal of the intentional leakage of the interface accessory.

[0019] In some embodiments, obtaining the total leakage based on the flow signal includes obtaining the instantaneous flow rate of the total leakage based on the flow signal; obtaining the intentional leakage of the interface accessory based on the pressure-flow correspondence between the pressure signal and the intentional leakage of the uniquely configured interface accessory includes obtaining the instantaneous flow rate of the intentional leakage of the interface accessory based on the pressure-flow correspondence between the pressure signal and the intentional leakage of the uniquely configured interface accessory; obtaining the unintentional leakage of the interface accessory based on the difference between the total leakage and the intentional leakage of the interface accessory includes obtaining the instantaneous flow rate signal of the unintentional leakage of the interface accessory based on the difference between the instantaneous flow rate of the total leakage and the instantaneous flow rate of the intentional leakage of the interface accessory.

[0020] In some embodiments, the method further includes: every first preset time interval, obtaining the average unintentional leakage of traffic from the interface attachment over a previous second preset time interval, wherein the length of the first preset time interval is less than the length of the second preset time interval; The average traffic of unintentional leaks from at least two of the interface attachments is averaged to obtain monitoring data of unintentional leaks from the interface attachments. The monitoring data of unintentional leaks from the interface attachments is compared with a preset threshold, and a prompt message is generated when the monitoring data of unintentional leaks from the interface attachments exceeds the preset threshold.

[0021] In some embodiments, the method further includes: adjusting the length of the first preset time and / or the second preset time in real time according to the breathing state of the ventilated object.

[0022] In some embodiments, an exhalation valve is further connected between the ventilation tubing and the interface accessory; the method further includes: performing a calibration procedure on the exhalation valve to obtain a pressure-flow correspondence for intentional leakage of the exhalation valve; the processor recalls the pressure-flow correspondence for intentional leakage of the exhalation valve and obtains the intentional leakage of the exhalation valve based on the pressure-flow correspondence for intentional leakage of the exhalation valve; the processor obtains the unintentional leakage of the interface accessory based on the total leakage minus the intentional leakage of the interface accessory and the intentional leakage of the exhalation valve.

[0023] A second aspect of this application provides a method for monitoring ventilation leakage in a medical ventilation device. The medical ventilation device includes a pressure generating device, a pressure sensor, a flow sensor, and a processor. The pressure generating device is connected to a ventilation tubing, which is connected to an interface accessory worn on the breathing area of ​​a person receiving ventilation, to deliver gas at a set pressure or flow rate to the person receiving ventilation through the ventilation tubing and the interface accessory. The processor controls the pressure generating device to generate the gas at the set pressure or flow rate. The method includes: acquiring a flow signal collected by the flow sensor and determining the total leakage based on the flow signal; acquiring a pressure signal collected by the pressure sensor; and the processor invoking a pre-configured first pressure-flow rate correspondence for intentional leakage of the interface accessory. The method further includes: obtaining a second pressure-flow rate correspondence for the intentional leakage of the interface accessory worn on the breathing part of the ventilated subject based on the pressure signal and the first pressure-flow rate correspondence; and obtaining an unintentional leakage of the interface accessory based on the difference between the total leakage and the intentional leakage of the interface accessory; the method also includes: during ventilation of the medical ventilation device, obtaining a second pressure-flow rate correspondence for the intentional leakage of the interface accessory; the second pressure-flow rate correspondence is different from the first pressure-flow rate correspondence; the processor invokes the second pressure-flow rate correspondence, obtains the intentional leakage of the interface accessory worn on the breathing part of the ventilated subject based on the pressure signal and the second pressure-flow rate correspondence; and obtains an unintentional leakage of the interface accessory based on the difference between the total leakage and the intentional leakage of the interface accessory.

[0024] In some embodiments, during the ventilation process of the medical ventilation device, obtaining a second pressure-flow correspondence for intentional leakage includes: monitoring the ventilation status of the ventilated object and automatically selecting the second pressure-flow correspondence based on the ventilation status of the ventilated object.

[0025] In some embodiments, during the ventilation process of the medical ventilation device, obtaining a second pressure-flow correspondence of intentional leakage includes: during the ventilation process of the medical ventilation device, obtaining and responding to a user-inputted selective instruction for the second pressure-flow correspondence of intentional leakage, so as to obtain the second pressure-flow correspondence.

[0026] In some embodiments, the first pressure-flow correspondence or the second pressure-flow correspondence is obtained based on pressure data from at least one interface accessory and intentionally leaked flow data, and is pre-configured in the medical ventilation device.

[0027] In some embodiments, the first pressure-flow correspondence or the second pressure-flow correspondence is obtained by fitting at least two sets of pressure data and intentionally leaked flow data from the interface accessory; or, the first pressure-flow correspondence or the second pressure-flow correspondence is obtained by averaging at least two sets of pressure data and intentionally leaked flow data from the interface accessory.

[0028] In some embodiments, the first pressure-flow rate correspondence or the second pressure-flow rate correspondence is obtained by piecewise fitting within at least two pressure intervals.

[0029] In some embodiments, the first pressure-flow rate correspondence or the second pressure-flow rate correspondence is obtained by polynomial fitting.

[0030] In some embodiments, the first pressure-flow correspondence or the second pressure-flow correspondence is selected from pressure-flow correspondences of at least two interface accessories.

[0031] In some embodiments, the pressure sensor is located at the interface accessory or at the device end of the medical ventilation device.

[0032] In some embodiments, obtaining the total leakage based on the flow signal includes obtaining the average flow rate of the total leakage based on the flow signal; obtaining the intentional leakage of the interface accessory based on the pressure signal and the first pressure-flow correspondence or the second pressure-flow correspondence includes obtaining the average flow rate of the intentional leakage of the interface accessory based on the pressure signal and the first pressure-flow correspondence or the second pressure-flow correspondence; obtaining the unintentional leakage of the interface accessory based on the difference between the total leakage and the intentional leakage of the interface accessory includes obtaining the average flow rate of the unintentional leakage of the interface accessory based on the difference between the average flow rate of the total leakage and the average flow rate of the intentional leakage of the interface accessory, and using this as the unintentional leakage of the interface accessory.

[0033] In some embodiments, obtaining the total leakage based on the flow signal includes: filtering the flow signal to obtain the average flow rate of the total leakage as the total leakage, wherein the filtering includes low-pass filtering or adaptive filtering.

[0034] In some embodiments, obtaining the total leakage based on the flow signal includes: extracting flow data for at least one respiratory cycle from the flow signal; and obtaining the average flow rate of the total leakage based on the average value of the flow data for the at least one respiratory cycle, as the total leakage.

[0035] In some embodiments, obtaining the average flow rate of intentional leakage of the interface accessory based on the pressure signal and the first pressure-flow correspondence or the second pressure-flow correspondence includes: filtering the pressure signal to obtain an average pressure, the filtering including low-pass filtering or adaptive filtering; and obtaining the average flow rate of intentional leakage of the interface accessory according to the average pressure and the first pressure-flow correspondence or the second pressure-flow correspondence.

[0036] In some embodiments, obtaining the average flow rate of intentional leakage of the interface accessory based on the pressure signal and the first pressure-flow correspondence or the second pressure-flow correspondence includes: extracting pressure data of at least one respiratory cycle from the pressure signal; obtaining an average pressure based on the average value of the pressure data of the at least one respiratory cycle; and obtaining the average flow rate of intentional leakage of the interface accessory based on the average pressure and the first pressure-flow correspondence or the second pressure-flow correspondence.

[0037] In some embodiments, obtaining the average flow rate of the intentional leakage of the interface accessory based on the pressure signal and the first pressure-flow correspondence or the second pressure-flow correspondence includes: obtaining the instantaneous flow rate signal of the intentional leakage of the interface accessory according to the pressure signal and the first pressure-flow correspondence or the second pressure-flow correspondence; filtering the instantaneous flow rate signal of the intentional leakage of the interface accessory to obtain the average flow rate of the intentional leakage of the interface accessory, wherein the filtering includes low-pass filtering or adaptive filtering.

[0038] In some embodiments, obtaining the average flow rate of the intentional leakage of the interface accessory based on the pressure signal and the first pressure-flow correspondence or the second pressure-flow correspondence includes: obtaining an instantaneous flow rate signal of the intentional leakage of the interface accessory according to the pressure signal and the first pressure-flow correspondence or the second pressure-flow correspondence; extracting instantaneous flow rate data of at least one respiratory cycle from the instantaneous flow rate signal of the intentional leakage of the interface accessory; and obtaining the average flow rate of the intentional leakage of the interface accessory based on the average value of the instantaneous flow rate data of at least one respiratory cycle extracted from the instantaneous flow rate signal of the intentional leakage of the interface accessory.

[0039] In some embodiments, obtaining the total leakage based on the flow signal includes: obtaining the instantaneous flow rate of the total leakage based on the flow signal; obtaining the intentional leakage of the interface accessory based on the pressure signal and the first pressure-flow correspondence or the second pressure-flow correspondence includes: obtaining the instantaneous flow rate of the intentional leakage of the interface accessory based on the pressure signal and the first pressure-flow correspondence or the second pressure-flow correspondence; obtaining the unintentional leakage of the interface accessory based on the difference between the total leakage and the intentional leakage includes: obtaining the instantaneous flow rate signal of the unintentional leakage based on the difference between the instantaneous flow rate of the total leakage and the instantaneous flow rate of the intentional leakage of the interface accessory.

[0040] In some embodiments, the method further includes: every first preset time interval, acquiring the average unintentional leakage traffic of the interface attachment over a previous second preset time interval, wherein the length of the first preset time interval is less than the length of the second preset time interval; averaging the average traffic of at least two unintentional leaks to obtain unintentional leakage monitoring data; comparing the unintentional leakage monitoring data with a preset threshold; and generating a prompt message when the unintentional leakage monitoring data exceeds the preset threshold.

[0041] In some embodiments, the method further includes: adjusting the length of the first preset time and / or the second preset time in real time according to the breathing state of the ventilated object.

[0042] In some embodiments, the ventilation tubing and the interface accessory are further connected to an exhalation valve; the method further includes: performing a calibration procedure on the exhalation valve to obtain a pressure-flow correspondence for intentional leakage of the exhalation valve; the processor recalls the pressure-flow correspondence for intentional leakage of the exhalation valve and obtains the intentional leakage of the exhalation valve based on the pressure-flow correspondence for intentional leakage of the exhalation valve; the processor obtains the unintentional leakage of the interface accessory based on the total leakage minus the intentional leakage of the interface accessory and the intentional leakage of the exhalation valve.

[0043] A third aspect of this application provides a method for monitoring ventilation leakage in a medical ventilation device. The medical ventilation device includes a pressure generating device, a pressure sensor, a flow sensor, and a processor. The pressure generating device is connected to a ventilation tubing, which is connected to an interface accessory worn on the breathing area of ​​a person receiving ventilation, to deliver gas at a set pressure or a set flow rate to the person receiving ventilation through the ventilation tubing and the interface accessory. An exhalation valve is also connected between the interface accessory and the ventilation tubing. The processor controls the pressure generating device to generate the gas at the set pressure or a set flow rate. The method includes: performing a calibration procedure on the exhalation valve to obtain a pressure-flow rate correspondence for intentional leakage of the exhalation valve; acquiring a flow signal collected by the flow sensor and obtaining a total leakage based on the flow signal; acquiring a pressure signal collected by the pressure sensor; obtaining an intentional leakage of the exhalation valve based on the pressure signal and the pressure-flow rate correspondence for intentional leakage of the exhalation valve; and obtaining an unintentional leakage of the interface accessory based on the difference between the total leakage and the intentional leakage of the exhalation valve.

[0044] In some embodiments, performing a calibration procedure on the exhalation valve to obtain a pressure-flow rate correspondence for intentional leakage of the exhalation valve includes: with the connection end between the exhalation valve and the interface accessory closed and the exhaust port of the exhalation valve open, the processor controls the pressure generating device to ventilate at multiple set pressures and controls the flow rate sensor to acquire the flow rate corresponding to each set pressure; the processor fits the multiple set pressures and their corresponding flow rates to obtain a pressure-flow rate correspondence for intentional leakage of the exhalation valve.

[0045] In some embodiments, before performing a calibration procedure for the exhalation valve to obtain the pressure-flow correspondence of intentional leakage of the exhalation valve, the method further includes: displaying a calibration interface for the exhalation valve, the calibration interface for receiving a selection instruction on whether an exhalation valve is connected between the interface accessory and the ventilation line, the calibration interface for the exhalation valve also displaying operation controls for starting the calibration procedure for the exhalation valve; when a selection instruction on whether an exhalation valve is connected between the interface accessory and the ventilation line is received through the calibration interface for the exhalation valve, and an operation instruction on the operation controls for starting the calibration procedure for the exhalation valve is received, the calibration procedure for the exhalation valve is started.

[0046] In some embodiments, the calibration interface of the exhalation valve is further configured to receive a selection instruction for the type of the interface accessory, wherein the type of the interface accessory includes an interface accessory with intentional leakage or an interface accessory without intentional leakage; the method further includes: when a selection instruction for an interface accessory of type with intentional leakage is received through the calibration interface of the exhalation valve, the processor invokes the pressure-flow correspondence of the intentional leakage of the interface accessory, and obtains the intentional leakage of the interface accessory based on the pressure signal and the pressure-flow correspondence of the intentional leakage of the interface accessory; the processor obtains the unintentional leakage of the interface accessory based on the total leakage minus the intentional leakage of the exhalation valve and the intentional leakage of the interface accessory.

[0047] In some embodiments, the method further includes: when a selection instruction for an interface accessory of type "no intentional leakage" is received through the calibration interface of the exhalation valve, the method is fixedly configured to connect an exhalation valve between the interface accessory and the ventilation line.

[0048] In some embodiments, the method further includes: displaying the calibration time and calibration result of the previous calibration procedure for the exhalation valve in the calibration interface of the exhalation valve; and / or displaying calibration prompt information in the calibration interface of the exhalation valve, the calibration prompt information being used to prompt that during the calibration procedure of the exhalation valve, the connection end between the exhalation valve and the interface accessory should be closed and the exhaust port of the exhalation valve should be kept open.

[0049] In some embodiments, obtaining the total leakage based on the flow signal includes obtaining the average flow rate of the total leakage based on the flow signal; obtaining the intentional leakage of the exhalation valve based on the pressure-flow rate correspondence between the pressure signal and the intentional leakage of the exhalation valve includes obtaining the average flow rate of the intentional leakage of the exhalation valve based on the pressure-flow rate correspondence between the pressure signal and the intentional leakage of the exhalation valve; obtaining the unintentional leakage of the interface accessory based on the difference between the total leakage and the intentional leakage of the exhalation valve includes obtaining the average flow rate of the unintentional leakage of the interface accessory based on the difference between the average flow rate of the total leakage and the average flow rate of the intentional leakage of the exhalation valve, as the unintentional leakage of the interface accessory.

[0050] In some embodiments, obtaining the average flow rate of the intentional leakage of the exhalation valve based on the pressure signal and the pressure-flow rate correspondence of the intentional leakage of the exhalation valve includes: filtering the pressure signal to obtain an average pressure, wherein the filtering includes low-pass filtering or adaptive filtering; and obtaining the average flow rate of the intentional leakage of the exhalation valve according to the average pressure and the pressure-flow rate correspondence of the intentional leakage of the exhalation valve.

[0051] In some embodiments, obtaining the average flow rate of the intentional leakage of the exhalation valve based on the pressure signal and the pressure-flow rate correspondence of the intentional leakage of the exhalation valve includes: extracting pressure data of at least one respiratory cycle from the pressure signal; obtaining an average pressure based on the average value of the pressure data of the at least one respiratory cycle; and obtaining the average flow rate of the intentional leakage of the exhalation valve based on the average pressure and the pressure-flow rate correspondence of the intentional leakage of the exhalation valve.

[0052] In some embodiments, obtaining the average flow rate of the intentional leakage of the exhalation valve based on the pressure signal and the pressure-flow correspondence of the intentional leakage of the exhalation valve includes: obtaining the instantaneous flow rate signal of the intentional leakage of the exhalation valve according to the pressure signal and the pressure-flow correspondence of the intentional leakage of the exhalation valve; filtering the instantaneous flow rate signal of the intentional leakage of the exhalation valve to obtain the average flow rate of the intentional leakage of the exhalation valve, wherein the filtering includes low-pass filtering or adaptive filtering.

[0053] In some embodiments, obtaining the average flow rate of the intentional leakage of the exhalation valve based on the pressure signal and the pressure-flow correspondence of the intentional leakage of the exhalation valve includes: obtaining an instantaneous flow rate signal of the intentional leakage of the exhalation valve based on the pressure signal and the pressure-flow correspondence of the intentional leakage of the exhalation valve; extracting instantaneous flow rate data of at least one respiratory cycle from the instantaneous flow rate signal of the intentional leakage of the exhalation valve; and obtaining the average flow rate of the intentional leakage of the exhalation valve based on the average value of the instantaneous flow rate data of at least one respiratory cycle extracted from the instantaneous flow rate signal of the intentional leakage of the exhalation valve.

[0054] In some embodiments, obtaining the total leakage based on the flow signal includes obtaining the instantaneous flow rate of the total leakage based on the flow signal; obtaining the intentional leakage of the exhalation valve based on the pressure-flow rate correspondence between the pressure signal and the intentional leakage of the exhalation valve includes obtaining the instantaneous flow rate of the intentional leakage of the exhalation valve based on the pressure-flow rate correspondence between the pressure signal and the intentional leakage of the exhalation valve; obtaining the unintentional leakage of the interface accessory based on the difference between the total leakage and the intentional leakage of the exhalation valve includes obtaining the instantaneous flow rate signal of the unintentional leakage of the interface accessory based on the difference between the instantaneous flow rate of the total leakage and the instantaneous flow rate of the intentional leakage of the exhalation valve.

[0055] A fourth aspect of this application provides a method for monitoring ventilation leakage in a medical ventilation device. The medical ventilation device includes a pressure generating device, a pressure sensor, a flow sensor, and a processor. The pressure generating device is connected to a ventilation tubing, which is connected to an interface accessory worn on the breathing part of a person being ventilated, to deliver gas at a set pressure or a set flow rate to the person being ventilated through the ventilation tubing and the interface accessory. The ventilation tubing includes the interface accessory worn on the breathing part of the person being ventilated. The processor is used to control the pressure generating device to generate the gas at the set pressure or set flow rate. The method includes: acquiring a flow signal collected by the flow sensor and obtaining a total leakage based on the flow signal; acquiring a pressure signal collected by the pressure sensor, calling a pre-configured pressure-flow rate correspondence for intentional leakage of the interface accessory, and obtaining an intentional leakage of the interface accessory based on the pressure signal and the pressure-flow rate correspondence, wherein the pressure-flow rate correspondence is applicable to multiple types of interface accessories; and obtaining an unintentional leakage of the interface accessory based on the difference between the total leakage and the intentional leakage of the interface accessory.

[0056] A fifth aspect of this application provides a medical ventilation device, comprising: a pressure generating device for communication with a ventilation tubing, the ventilation tubing being connected to an interface accessory worn on the breathing part of a person being ventilated, for delivering gas at a set pressure or a set flow rate to the person being ventilated through the ventilation tubing and the interface accessory; a flow sensor for acquiring a flow signal during the delivery of gas to the person being ventilated; a pressure sensor for acquiring a pressure signal during the delivery of gas to the person being ventilated; and a processor connected to the flow sensor, the pressure signal, and the pressure generating device for acquiring the flow signal and the pressure signal, and controlling the pressure generating device to generate gas at the set pressure or a set flow rate; the processor is further configured to execute the ventilation leak monitoring method described above.

[0057] According to the embodiments of this application, the method for monitoring ventilation leakage of medical ventilation equipment and the medical ventilation equipment are configured with a unique pressure-flow correspondence for intentional leakage to correspond to multiple types of interface accessories. The intentional leakage of the interface accessory is obtained based on the uniquely configured pressure-flow correspondence applicable to multiple types of interface accessories, without the need for the user to select the applicable pressure-flow correspondence. After obtaining the intentional leakage and total leakage of the interface accessory, the unintentional leakage of the interface accessory is obtained based on the difference between the total leakage and the intentional leakage of the interface accessory, thereby realizing the automatic monitoring of unintentional leakage. Attached Figure Description

[0058] To more clearly illustrate the technical solutions in the embodiments of this application, the accompanying drawings used in the description of the embodiments will be briefly introduced below. Obviously, the accompanying drawings described below are only some embodiments of this application. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0059] In the attached diagram: Figure 1 A schematic flowchart illustrating a method for monitoring ventilation leaks in a medical ventilation device according to an embodiment of this application; Figure 2 This diagram illustrates filtering of a traffic signal according to an embodiment of the present application; Figure 3 A schematic diagram illustrating the pressure-flow correspondence of an intentionally leaked interface accessory according to an embodiment of this application; Figure 4 This diagram illustrates a pressure signal filtering process according to an embodiment of the present application. Figure 5 A schematic flowchart illustrating a method for monitoring ventilation leaks in a medical ventilation device according to an embodiment of this application is shown. Figure 6 A schematic diagram illustrating an unintentional disclosure display method according to an embodiment of this application; Figure 7 A schematic flowchart illustrating a method for monitoring ventilation leaks in a medical ventilation device according to another embodiment of this application; Figure 8 A schematic flowchart illustrating a method for monitoring ventilation leaks in a medical ventilation device according to another embodiment of this application; Figure 9 A schematic diagram showing the calibration interface of an exhalation valve according to an embodiment of this application; Figure 10 A schematic flowchart illustrating a method for monitoring ventilation leaks in a medical ventilation device according to another embodiment of this application; Figure 11 A schematic block diagram of a medical ventilation device according to an embodiment of this application is shown. Detailed Implementation

[0060] To make the objectives, technical solutions, and advantages of this application more apparent, exemplary embodiments according to this application will be described in detail below with reference to the accompanying drawings. Obviously, the described embodiments are merely some embodiments of this application, and not all embodiments of this application. It should be understood that this application is not limited to the exemplary embodiments described herein. Based on the embodiments of this application described herein, all other embodiments obtained by those skilled in the art without inventive effort should fall within the protection scope of this application.

[0061] The following description provides numerous specific details to offer a more thorough understanding of this application. However, it will be apparent to those skilled in the art that this application can be practiced without one or more of these details. In other instances, certain technical features well-known in the art have not been described to avoid confusion with this application.

[0062] It should be understood that this application can be implemented in various forms and should not be construed as being limited to the embodiments set forth herein. Rather, providing these embodiments will make the disclosure thorough and complete, and will fully convey the scope of this application to those skilled in the art.

[0063] The terminology used herein is for the purpose of describing particular embodiments only and is not intended to limit the scope of this application. When used herein, the singular forms “a,” “an,” and “the” are also intended to include the plural forms unless the context clearly indicates otherwise. It should also be understood that the terms “comprising” and / or “including,” when used in this specification, identify the presence of the stated features, integers, steps, operations, elements, and / or components, but do not exclude the presence or addition of one or more other features, integers, steps, operations, elements, components, and / or groups. When used herein, the term “and / or” includes any and all combinations of the associated listed items.

[0064] To fully understand this application, a detailed structure will be presented in the following description to illustrate the technical solution proposed in this application. Optional embodiments of this application are described in detail below; however, in addition to these detailed descriptions, this application may have other implementation methods.

[0065] The following is a reference. Figure 1This application describes a method for monitoring ventilation leaks in a medical ventilation device according to embodiments of the present application. The medical ventilation device of this application can provide mechanical ventilation to a patient, such as a ventilator or anesthesia machine. The medical ventilation device includes at least a pressure generating device, a pressure sensor, a flow sensor, and a processor. The pressure generating device is connected to a ventilation tubing, which is connected to an interface accessory worn on the breathing area of ​​the patient to deliver gas at a set pressure or flow rate to the patient through the ventilation tubing and the interface accessory. The interface accessory includes a face mask, nasal mask, head cover, etc. The medical ventilation device is configured with a unique intentionally leaked pressure-flow rate correspondence to various types of interface accessories that can be worn on the breathing area of ​​the patient. This unique intentionally leaked pressure-flow rate correspondence can be stored in the memory of the medical ventilation device. The processor controls the pressure generating device to generate gas at a set pressure or flow rate. The processor is also used to perform the following method to monitor ventilation leaks in the medical ventilation device. Figure 1 This is a schematic flowchart of a method 100 for monitoring ventilation leaks in a medical ventilation device according to an embodiment of this application, which specifically includes the following steps: In step S110, the flow signal collected by the flow sensor is acquired, and the total leakage is obtained based on the flow signal; In step S120, the pressure signal collected by the pressure sensor is acquired; In step S130, the processor calls the uniquely configured intentional leakage pressure-flow correspondence and obtains the intentional leakage of the interface accessory worn by the breathing part of the ventilated object based on the pressure signal and the uniquely configured intentional leakage pressure-flow correspondence. In step S140, the processor obtains the unintentional leakage of the interface attachment based on the difference between the total leakage and the intentional leakage of the interface attachment.

[0066] The method 100 for monitoring ventilation leakage in medical ventilation equipment according to embodiments of this application is mainly used to monitor unintentional leakage at the contact surface between the interface accessory and the ventilated object. Non-invasive ventilators exhale through the ventilator's ventilator ventilator or passive expiratory valve, and leakage is unavoidable during ventilation. Ideally, all leaked gas should overflow from the ventilator ventilator or passive expiratory valve; this is gas that is required for normal ventilation and is referred to as intentional leakage. In actual use, the contact surface between the interface accessory and the patient cannot be completely sealed, causing some gas to leak out at the contact surface. This is gas that is not expected to leak out during normal ventilation, and this part of the leakage is referred to as unintentional leakage or patient-side leakage. The sum of intentional and unintentional leakage is the total leakage. The method 100 for monitoring ventilation leakage in a medical ventilation device according to an embodiment of this application pre-configures a unique pressure-flow correspondence for intentional leaks in the medical ventilation device, corresponding to various types of interface accessories that can be worn on the breathing part of the ventilated object. When calculating unintentional leaks, the processor of the medical ventilation device calls the unique pressure-flow correspondence for intentional leaks to obtain the intentional leaks of the interface accessories, without requiring the user to select the applicable pressure-flow correspondence. After obtaining the intentional leaks and the total leak, the unintentional leaks of the interface accessories are obtained based on the difference between the total leak and the intentional leak, thereby realizing the automatic monitoring of unintentional leaks.

[0067] For example, in step S110, the total leakage is obtained based on the flow signal. The flow signal is the flow signal collected by the flow sensor of the medical ventilation device during ventilation. The flow sensor is generally installed at the device end of the medical ventilation device and can detect the gas velocity in the ventilation line in real time when the gas flow rate changes, and calculate the corresponding gas flow rate based on the area of ​​the ventilation line and the detected gas velocity.

[0068] For example, obtaining the total leakage based on the flow signal specifically includes obtaining the average flow rate of the total leakage based on the flow signal. Since the flow signal characterizes the flow rate of gas supplied to the ventilated object through the ventilation line, with a portion of the gas used for breathing and another portion leaking through the interface accessories, let the original flow signal be... The total leakage flow rate is The flow rate of the ventilated object is Then the three satisfy the following relationship: (Formula 1) Since the tidal volume of the ventilated subject is approximately equal during inhalation and exhalation within a single respiratory cycle, the cumulative flow rate of the ventilated subject in a single respiratory cycle is 0, which satisfies the following condition: (Formula 2) in, Inhalation time, This refers to the exhalation time.

[0069] Combining formulas 1 and 2, we get: (Formula 3) Let the average flow signal within a single respiratory cycle be _____. The average flow rate of the total leakage is Then, according to the definition of average value, we have: (Formula 4) As shown in Formula 4, the average value of the flow signal can represent the average flow rate of the total leakage. The essence of obtaining the average flow rate of the total leakage based on the average value of the flow signal is to ignore the flow fluctuations caused by inhalation and exhalation, and extract the baseline of the flow signal within a certain time period. The value of the baseline can approximately represent the magnitude of the average flow rate of the total leakage within that time period. Therefore, as one implementation method, flow data for at least one respiratory cycle can be directly extracted from the flow signal, and the average flow rate of the total leakage can be obtained based on the average value of the flow data for at least one respiratory cycle.

[0070] In another embodiment, the flow signal can also be filtered to obtain the average flow rate of the total leakage. Filtering methods include low-pass filtering or adaptive filtering. Filtering allows the baseline of the flow signal to be extracted, with reference to... Figure 2 , Figure 2 The original and filtered flow signals are shown. The original flow signal has a larger amplitude during inhalation and a smaller amplitude during exhalation, with a baseline that is a positive value deviating from the origin. Taking low-pass filtering as an example, let the original flow signal be... The average flow rate after low-pass filtering is The relationship between the two can be expressed as: (Formula 5) in, This represents a low-pass filtering operation. Low-pass filtering can suppress high-frequency components of a signal while preserving low-frequency components. When the cutoff frequency of the low-pass filter is lower than the ventilation frequency of the ventilated individual, flow fluctuations during inspiration and expiration are considered high-frequency disturbances and suppressed; the flow baseline represents the flow change trend, and the low-frequency components of the signal are preserved. Therefore, the baseline extraction method based on low-pass filtering can obtain the average value of the flow signal, i.e., the average flow of total leakage, without relying on the respiratory cycle, allowing the calculation of total leakage to be solved independently of the respiratory rhythm.

[0071] The average flow rate of the total leakage can be obtained by filtering or averaging. To monitor unintentional leakage, it is also necessary to obtain the intentional leakage of the interface accessories. The difference between the total leakage and the intentional leakage of the interface accessories can then be used to determine the unintentional leakage. Interface accessories include face masks, nasal masks, and head covers. Face masks include perforated masks or closed masks with passive exhalation valves. Intentional leakage occurs, for example, at the perforations of the face mask. Taking a perforated face mask as an example, the leakage holes on the mask are rigid holes with fixed dimensions. Therefore, the leakage process can be described using a small-hole model. Let the pressure on the face mask during ventilation be... Its leakage flow rate is Then the two satisfy the following relationship: (Formula 6) Where K is the leakage coefficient, which reflects the leakage capacity of the mask.

[0072] As described above, intentional leakage of the interface accessory can be obtained based on the pressure of the interface accessory. Therefore, in step S120, the processor invokes the uniquely configured pressure-flow correspondence of the interface accessory, and obtains the intentional leakage of the interface accessory based on the pressure signal and the uniquely configured pressure-flow correspondence of the interface accessory. The pressure signal is the pressure signal collected by the pressure sensor of the medical ventilation device during ventilation. The pressure sensor is generally located at the interface accessory to measure the pressure of the interface accessory. Optionally, the pressure sensor can also be located at the device end of the medical ventilation device.

[0073] Interface accessories are accessories for medical ventilation equipment. To facilitate clinical use, most medical ventilation equipment is compatible with interface accessories from other manufacturers. The shape, size, and number and size of leakage holes vary among different manufacturers' interface accessories, resulting in different leakage coefficients. To accurately estimate the intentional leakage of interface accessories during ventilation, one method is to pre-configure multiple pressure-flow correspondences for different manufacturers. Before using a particular interface accessory to ventilate the patient, the mask type needs to be selected on the operating interface to guide the medical ventilation equipment to use the corresponding pressure-flow correspondence to estimate the intentional leakage of the interface accessory. This process is complex and increases the user's workload. Furthermore, there are numerous manufacturers selling interface accessories on the market. To adapt to different ventilated patients, the same manufacturer may produce several or even a dozen different models of interface accessories. The interface accessory selection interface and built-in programs of medical ventilation equipment cannot include all interface accessory types and their corresponding pressure-flow correspondences for intentional leakage. When the actual interface accessory model used is not included, the accuracy of the intentional leakage calculation cannot be guaranteed.

[0074] To address the above issues, this application pre-configures a uniquely configured intentional leakage pressure-flow correspondence for various types of interface accessories in the medical ventilation equipment. This simplifies the operation process by eliminating the need for users to select the appropriate intentional leakage pressure-flow correspondence for the currently used interface accessory, while also ensuring the calculation accuracy for various types of interface accessories. The pressure-flow correspondence in this application can refer to the relationship between the intentional leakage pressure and flow rate of the interface accessory, the coefficients of the relationship, the pressure-flow curve, the pressure-flow table, etc. In one embodiment, the uniquely configured intentional leakage pressure-flow correspondence is obtained based on the pressure data and intentional leakage flow rate data of at least one interface accessory and is pre-configured in the medical ventilation equipment. Specifically, the uniquely configured intentional leakage pressure-flow correspondence can be obtained based on the pressure data and intentional leakage flow rate data of at least two interface accessories, or it can be obtained based on multiple sets of pressure data and intentional leakage flow rate data of one interface accessory.

[0075] Furthermore, the pressure-flow correspondence for intentional leakage of a uniquely configured interface accessory can be obtained by fitting at least two sets of pressure data and intentional leakage flow data of the interface accessory. These at least two sets of pressure data and intentional leakage flow data of the interface accessory can come from interface accessories from different manufacturers or different models. For example, two sets of pressure data and their intentional leakage flow data for several frequently used clinical interface accessories can be fitted into a curve as a template for estimating intentional leakage for all types of interface accessories. See [link to relevant documentation] Figure 3 , Figure 3 The diagram shows the pressure-flow curves for the interface accessories from manufacturers 1, 2, 3, and 4, as well as fitted pressure-flow curves applicable to various types of interface accessories. For example, the pressure-flow correspondence can be obtained by fitting a polynomial or any other suitable fitting method.

[0076] In one embodiment, the pressure-flow correspondence of intentional leakage for a uniquely configured interface accessory is obtained by piecewise fitting over at least two pressure ranges. Table 1 shows the flow rate data of intentional leakage for face masks provided by four manufacturers, as well as the flow rate deviation between intentional leakage of face masks from different manufacturers at the same pressure.

[0077] Table 1 As shown in Table 1, when the pressure is low (4-5 cmH2O), the flow deviation due to intentional leakage between masks is large (greater than 15%), while when the pressure is high, the flow deviation due to intentional leakage between masks can be controlled within 10%. Therefore, segmented fitting within at least two pressure ranges can improve the fitting accuracy.

[0078] Set pressure Below, the intentionally leaked traffic for four different interface attachments is as follows: , , , The flow rate corresponding to the fitted curve under pressure P is... It can be represented as: (Formula 7) in, To fit the weighting coefficients, the pressure was divided into two intervals: 4-10 cmH2O and 10-30 cmH2O. Data points within each interval were used for each interval. Fitting P- Its equation is as follows: (Formula 8) in, For pressure, To fit the flow rate, The leakage coefficient is given when the pressure is 4-10 cmH2O. The leakage coefficient is given when the pressure is 10-30 cmH2O. Figure 3 The curve shown is the fitted curve corresponding to Formula 3.

[0079] Referring to Table 2, which shows the deviation between the fitted flow rate and the official flow rate of the interface accessory for intentional leakage at seven pressure points (4cmH2O, 5cmH2O, 10cmH2O, 15cmH2O, 20cmH2O, 25cmH2O, and 30cmH2O), the fitted curve is shown.

[0080] Table 2 As shown in Table 2, after piecewise fitting, the deviation between the official flow rates of intentional leakage of interface accessories published by the four manufacturers and the flow rates obtained from the fitted curves can be controlled within 5% at most pressure points. For a few pressure points, the deviation is larger, but still controlled within 15%, and the absolute value of the flow rate deviation is within 3 L / min. This demonstrates that using fitted curves to estimate intentional leakage of all types of interface accessories can ensure calculation accuracy.

[0081] Besides using the curve fitting method described above to obtain the pressure-flow correspondence of intentional leakage for a uniquely configured interface accessory, the pressure-flow correspondence of intentional leakage for a uniquely configured interface accessory can also be selected from at least two pressure-flow correspondences of intentional leakage for interface accessories. Specifically, the pressure-flow correspondences of intentional leakage for at least two interface accessories can be evaluated in advance, and a unique pressure-flow correspondence is selected from the at least two pressure-flow correspondences of intentional leakage for at least two interface accessories that ensures that the flow error of intentional leakage for multiple interface accessories meets the preset requirements. Alternatively, the pressure-flow correspondence of intentional leakage for a uniquely configured interface accessory can also be obtained by averaging at least two sets of pressure data and the flow data of intentional leakage for the interface accessory.

[0082] After invoking the intentional leakage pressure-flow correspondence of the uniquely configured interface attachment, the intentional leakage flow of the interface attachment can be calculated based on the invoked pressure-flow correspondence and the pressure. For example, if the average flow of total leakage is obtained in step S110, then in step S120, the average flow of intentional leakage of the interface attachment is obtained based on the pressure signal and the pressure-flow correspondence. Subsequently, the average flow of unintentional leakage can be obtained based on the difference between total leakage and intentional leakage of the interface attachment.

[0083] To obtain the average flow rate of intentionally leaked interface attachments, one approach is to first obtain the average pressure based on the pressure signal, and then calculate the average flow rate of intentionally leaked interface attachments based on the correspondence between the average pressure and the pressure-flow rate of the invoked request. One method for obtaining the average pressure from the pressure signal is to filter the pressure signal to obtain the average pressure; filtering methods include low-pass filtering or adaptive filtering. See also... Figure 4 Let the initial pressure be... The pressure after low-pass filtering is The relationship between the two can be expressed as: (Formula 9) in, This represents a low-pass filter operation. Combining this with the pressure-flow correspondence described above, the average flow rate intentionally leaked from the interface accessories... It can be represented as: (Formula 10) Correspondingly, the average traffic unintentionally leaked by the interface attachments for: (Formula 11) Optionally, when obtaining the average pressure based on the pressure signal, pressure data for at least one respiratory cycle can also be extracted from the pressure signal, and the average pressure can be obtained based on the average value of the pressure data for at least one respiratory cycle.

[0084] Another method for obtaining the average flow rate of intentional leakage of the interface accessory based on the pressure signal and pressure-flow correspondence is as follows: First, obtain the instantaneous flow rate signal of the intentional leakage of the interface accessory based on the pressure signal and pressure-flow correspondence. Then, obtain the average flow rate of the intentional leakage of the interface accessory based on the instantaneous flow rate signal. The instantaneous flow rate signal of the intentional leakage of the interface accessory represents the change of the instantaneous flow rate of the intentional leakage of the interface accessory over time. The method for obtaining the average flow rate of the intentional leakage of the interface accessory based on the instantaneous flow rate signal is similar to the method for obtaining the average flow rate of the total leakage based on the flow signal described above. Specifically, one method is to filter the instantaneous flow rate signal of the intentional leakage of the interface accessory to obtain the average flow rate of the intentional leakage of the interface accessory. The filtering method includes low-pass filtering or adaptive filtering. Using the filtering method allows the calculation of the intentional leakage of the interface accessory to be solved independently of the respiratory rhythm. Another method is to extract the instantaneous flow rate data of at least one respiratory cycle from the instantaneous flow rate signal of the intentional leakage of the interface accessory, and obtain the average flow rate of the intentional leakage of the interface accessory based on the average value of the extracted instantaneous flow rate data of at least one respiratory cycle.

[0085] In some embodiments, obtaining the total leakage based on the flow signal includes obtaining the instantaneous flow rate of the total leakage based on the flow signal; obtaining the intentional leakage of the interface accessory based on the pressure signal and the pressure-flow correspondence of the intentional leakage of the uniquely configured interface accessory includes obtaining the instantaneous flow rate of the intentional leakage of the interface accessory based on the pressure signal and the pressure-flow correspondence; then, the instantaneous flow rate signal of the unintentional leakage of the interface accessory is obtained based on the difference between the instantaneous flow rate of the total leakage and the instantaneous flow rate of the intentional leakage of the interface accessory. Exemplarily, the instantaneous flow rate of the total leakage may be the average flow rate of the total leakage at each moment. After obtaining the instantaneous flow rate signal of the unintentional leakage of the interface accessory, it can be filtered or averaged to obtain the average flow rate of the intentional leakage of the interface accessory.

[0086] After obtaining the total leakage and the intentional leakage of the interface attachment, the processor determines the unintentional leakage of the interface attachment based on the difference between the total leakage and the intentional leakage of the interface attachment. In some embodiments, the processor directly uses the difference between the total leakage and the intentional leakage of the interface attachment as the unintentional leakage of the interface attachment, i.e.: (Formula 12) In Formula 12, FLeak patient This indicates an unintentional leak of the interface attachments, FLeak totalIndicates total leakage, FLeak mask This indicates an intentional leak of the interface attachments.

[0087] In some embodiments, an exhalation valve is also connected between the ventilation tubing and the interface accessory. The exhalation valve, serving as the outlet for non-invasive ventilation exhalation, works in conjunction with the interface accessory to ensure both effective ventilation and comfort for the ventilated individual, as well as to guarantee exhalation. When no exhalation valve is connected between the interface accessory and the ventilation tubing, the difference between the total leakage and the intentional leakage of the interface accessory can be directly taken as the unintentional leakage of the interface accessory. When an exhalation valve is connected between the interface accessory and the ventilation tubing, the intentional leakage includes both the intentional leakage of the interface accessory and the intentional leakage of the exhalation valve. Therefore, the unintentional leakage of the interface accessory can be obtained by subtracting the intentional leakage of the interface accessory and the intentional leakage of the exhalation valve from the total leakage. (Formula 13) Among them, FLeak expvalve This indicates an intentional leak from the exhalation valve.

[0088] Therefore, when an exhalation valve is connected between the ventilation tubing and the interface accessories, the intentional leakage of the exhalation valve must be calculated in addition to the intentional leakage of the interface accessories. The intentional leakage of the exhalation valve can be calculated based on the pressure signal acquired by the pressure sensor and the pressure-flow rate correlation of the intentional leakage of the exhalation valve. To improve the accuracy of the calculation, a calibration procedure for the exhalation valve can be executed to obtain the pressure-flow rate correlation of the intentional leakage of the exhalation valve. The processor then retrieves this correlation and calculates the intentional leakage of the exhalation valve based on the pressure signal and the pressure-flow rate correlation.

[0089] For example, the calibration procedure for the exhalation valve can be performed before the medical ventilation device is used. Specifically, with the connection between the exhalation valve and the interface accessory closed and the exhaust port of the exhalation valve open, the processor controls the control pressure generating device to ventilate at multiple set pressures (P1, P2...PN), and controls the flow rate sensor to acquire the flow rate (F1, F2...FN) corresponding to each set pressure; the processor fits the multiple set pressures and their corresponding flow rates to obtain the pressure-flow rate correspondence for intentional leakage of the exhalation valve.

[0090] Since a calibration procedure is required to obtain intentional leakage of the expiratory valve only when the expiratory valve is connected between the ventilation line and the interface accessory, a calibration interface for the expiratory valve can be displayed before performing the calibration procedure to obtain the pressure-flow correspondence of the intentional leakage. This interface receives a selection command regarding whether an expiratory valve is connected between the interface accessory and the ventilation line, thus determining whether to initiate the calibration procedure. The calibration interface also displays operating controls for initiating the calibration procedure. When the calibration interface receives a selection command regarding the connection of the expiratory valve between the interface accessory and the ventilation line, and also receives an operating command to initiate the calibration procedure, the calibration procedure is initiated.

[0091] For example, the calibration interface of the exhalation valve displays the calibration time and result of the previous calibration procedure performed on the exhalation valve. The calibration interface also displays calibration prompts to ensure that the connection between the exhalation valve and the interface accessory remains closed and the exhaust port of the exhalation valve remains open during the calibration procedure.

[0092] In other embodiments, the pressure-flow rate correlation for intentional leakage of the exhalation valve can be obtained based on pressure data and intentional leakage flow rate data of at least one exhalation valve. For example, it can be obtained by fitting or averaging at least two sets of pressure data and intentional leakage flow rate data of the exhalation valve. The at least two sets of pressure data and intentional leakage flow rate data can come from interface accessories of different manufacturers or different models. Alternatively, the pressure-flow rate correlation for intentional leakage of the exhalation valve can also be selected from at least two pressure-flow rate correlations of exhalation valves and pre-configured in the medical ventilation device.

[0093] The unintentional leakage of interface attachments can be calculated using the method described above. In some embodiments, the calculated unintentional leakage of interface attachments can be directly used as a monitoring parameter, displayed, or an alarm message can be generated when it exceeds a preset threshold. For example, see... Figure 6 Unintentional leaks from interface accessories can be displayed graphically. The graphical representation includes the current value of the unintentional leak, an indicator bar, and a pointer. The indicator bar indicates the range of the unintentional leak, and the pointer indicates the position of the current value within that range. Unintentional leaks from interface accessories can also be displayed in the monitoring value area of ​​the main interface of the medical ventilation equipment.

[0094] In another embodiment, the average flow rate of unintentional leakage from the interface can be further processed. For example, a filtering method is used when calculating the average flow rate of total leakage and the average flow rate of intentional leakage, which largely suppresses flow fluctuations during inhalation and exhalation. The degree of flow fluctuation suppression is negatively correlated with the cutoff frequency of the filter. However, to ensure the accuracy of the average flow rate, a lower cutoff frequency is not always better. This means that the filtered flow rate and pressure will still retain some rhythmic information, exhibiting slight fluctuations with the respiratory cycle. Therefore, to ensure the stability of the monitoring parameters, an appropriate time window can be selected to perform superimposed averaging processing on the average flow rate of unintentional leakage.

[0095] Specifically, at first preset time intervals, the average flow rate of unintentional leaks over a previous second preset time interval is acquired, where the length of the first preset time interval is shorter than the length of the second preset time interval. The average flow rates of at least two unintentional leaks are averaged to obtain unintentional leak monitoring data. This unintentional leak monitoring data is compared with a preset threshold, and a prompt message is generated when the unintentional leak monitoring data exceeds the preset threshold. (Refer to...) Figure 5 Taking a first preset time of 20 seconds and a second preset time of 1 minute as an example, the average flow rate of unintentional leakage within the previous minute is calculated every 20 seconds as FLPMeanPatient. The monitoring data for unintentional leakage is the average value MVLeakPatient of multiple FLPMeanPatients, where MVLeakPatient = MeanSUM(FMeanPatient). MVLeakPatient is used as a monitoring parameter, and an alarm is generated when it exceeds a preset threshold. The multiple FLPMeanPatients refer to multiple FLPMeanPatients obtained within the parameter refresh time, which can be the second preset time. Figure 5 The example is 1 minute.

[0096] For example, the lengths of the first preset time and the second preset time can be adjusted in real time according to the respiratory status of the ventilated subject. The respiratory status of the ventilated subject includes the respiratory rhythm and respiratory stability. When the respiratory rhythm of the ventilated subject is fast or the breathing is unstable, the lengths of the first preset time and the second preset time can be appropriately reduced to ensure the real-time monitoring of the parameters. When the respiratory rhythm of the ventilated subject is slow and the breathing is relatively stable, the lengths of the first preset time and the second preset time can be appropriately increased to increase the stability of the monitoring parameters.

[0097] In one embodiment, invoking the pre-configured intentional leakage pressure-flow correspondence of the interface accessory includes: performing the step of invoking the pre-configured intentional leakage pressure-flow correspondence of the interface accessory without relying on the user's direct operation of the medical ventilation device. In this embodiment, the user's direct operation of the medical ventilation device refers to the user's direct manipulation of the device to select and invoke the pressure-flow correspondence. In this embodiment, the invocation of the intentional leakage pressure-flow correspondence of the interface accessory is not performed through direct user operation and does not require subjective user action. Therefore, it simplifies user operation and may enable the device to automatically execute the invocation of the pre-configured pressure-flow correspondence of the interface accessory for leakage calculation.

[0098] Based on the above description, the method 100 for monitoring ventilation leakage of medical ventilation equipment in this application embodiment is configured with a unique pressure-flow correspondence for intentional leakage to correspond to multiple types of interface accessories. The intentional leakage of the interface accessory is obtained according to the uniquely configured pressure-flow correspondence applicable to multiple types of interface accessories, without the need for the user to select the applicable pressure-flow correspondence. After obtaining the intentional leakage and the total leakage, the unintentional leakage of the interface accessory is obtained based on the difference between the total leakage and the intentional leakage of the interface accessory, thereby realizing the automatic monitoring of unintentional leakage. It can guide medical staff to adjust the tightness of the interface accessory through unintentional leakage.

[0099] See Figure 7 Another aspect of this application provides a method 700 for monitoring ventilation leaks in a medical ventilation device. The medical ventilation device includes a pressure generating device, a pressure sensor, a flow sensor, and a processor. The pressure generating device is connected to a ventilation line to deliver gas at a set pressure or flow rate to the person being ventilated. The ventilation line includes an interface accessory worn on the breathing area of ​​the person being ventilated. The processor controls the pressure generating device to generate the gas at the set pressure or flow rate. The pressure sensor is located at the interface accessory or at the device end of the medical ventilation device to measure the pressure at the interface accessory or the device end. The method 700 for monitoring ventilation leaks in a medical ventilation device specifically includes the following steps: In step S710, the flow signal collected by the flow sensor is acquired, and the total leakage is obtained based on the flow signal; In step S720, the pressure signal collected by the pressure sensor is acquired; In step S730, the processor invokes a pre-configured first pressure-flow correspondence for intentional leakage of the interface accessory, and obtains the first intentional leakage of the interface accessory worn on the breathing part of the ventilated object based on the pressure signal and the first pressure-flow correspondence; and obtains the unintentional leakage of the interface accessory based on the difference between the total leakage and the intentional leakage. In step S740, during the ventilation process of the medical ventilation device, a second pressure-flow correspondence for intentional leakage of the interface accessory is obtained, and the second pressure-flow correspondence is different from the first pressure-flow correspondence. In step S750, the processor invokes the intentionally leaked second pressure-flow correspondence, obtains the intentional leakage of the interface accessory worn on the breathing part of the ventilated object based on the pressure signal and the second pressure-flow correspondence, and obtains the unintentional leakage of the interface accessory based on the difference between the total leakage and the intentional leakage of the interface accessory.

[0100] According to an embodiment of the present invention, a method 700 for monitoring ventilation leakage in a medical ventilation device pre-configures pressure-flow correspondences for intentional leaks of at least two interface accessories in the medical ventilation device, and can switch the pressure-flow correspondences during ventilation to ensure that the pressure-flow correspondences for intentional leaks of the applied interface accessories meet the current needs, thereby improving the accuracy of monitoring unintentional leaks of the interface accessories.

[0101] In some embodiments, the processor of the medical ventilation device can automatically switch the pressure-flow correspondence. For example, the ventilation status of the ventilated subject can be monitored, and a second pressure-flow correspondence can be automatically selected based on the ventilation status. When configuring intentionally leaked pressure-flow correspondences for at least two interface accessories, the applicable ventilation status for the intentionally leaked pressure-flow correspondence of each interface accessory can be predetermined, thereby automatically selecting the second pressure-flow correspondence based on the ventilation status of the ventilated subject during ventilation. In some embodiments, the switching of the pressure-flow correspondence can also be performed manually by the user. Specifically, during the ventilation process of the medical ventilation device, a user-inputted selective command for an intentionally leaked second pressure-flow correspondence is acquired and responded to to obtain the second pressure-flow correspondence.

[0102] Among them, the first pressure-flow correspondence or the second pressure-flow correspondence can refer to the relationship between the intentionally leaked pressure and flow rate of the interface accessory, the coefficients of the relationship, the pressure-flow curve, the pressure-flow table, etc.

[0103] In some embodiments, the first pressure-flow rate correspondence or the second pressure-flow rate correspondence is obtained based on pressure data and intentionally leaked flow rate data from at least one interface accessory, and is pre-configured in the medical ventilation device. Specifically, the first pressure-flow rate correspondence or the second pressure-flow rate correspondence may be obtained based on pressure data and intentionally leaked flow rate data from at least two interface accessories, or it may be obtained based on multiple sets of pressure data and intentionally leaked flow rate data from one interface accessory.

[0104] Furthermore, the first pressure-flow rate correlation or the second pressure-flow rate correlation can be obtained by fitting at least two sets of pressure data and intentionally leaked flow rate data from the interface accessory. The at least two sets of pressure data and the intentionally leaked flow rate data from the interface accessory can come from different manufacturers or different models of interface accessories. For example, two sets of pressure data and their intentionally leaked flow rate data from several frequently used clinical interface accessories can be fitted into a curve to serve as the first pressure-flow rate correlation or the second pressure-flow rate correlation. Exemplarily, the first pressure-flow rate correlation or the second pressure-flow rate correlation can be obtained by fitting using a polynomial or any other suitable fitting method.

[0105] In one embodiment, the first pressure-flow correspondence or the second pressure-flow correspondence is obtained by piecewise fitting within at least two pressure intervals. When the pressure is low, the flow deviation due to intentional leakage between interface accessories is large, while when the pressure is high, the flow deviation due to intentional leakage between interface accessories is small. Therefore, piecewise fitting within at least two pressure intervals can improve fitting accuracy.

[0106] Besides obtaining the first or second pressure-flow correspondence using the curve fitting method described above, the first or second pressure-flow correspondence can also be selected from the pressure-flow correspondences of intentional leaks in at least two interface accessories. Specifically, the pressure-flow correspondences of intentional leaks in at least two interface accessories can be evaluated in advance, and the first or second pressure-flow correspondence can be selected from the pressure-flow correspondences of intentional leaks in at least two interface accessories so that the flow errors of intentional leaks in multiple interface accessories all meet the preset requirements. Alternatively, the first or second pressure-flow correspondence can also be obtained by averaging at least two sets of pressure data and the flow data of intentional leaks in the interface accessories.

[0107] In one embodiment, obtaining the total leakage based on the flow signal includes obtaining the average flow rate of the total leakage based on the flow signal. Obtaining the intentional leakage of the interface accessory based on the pressure signal and a first pressure-flow correspondence or a second pressure-flow correspondence includes obtaining the average flow rate of the intentional leakage of the interface accessory based on the pressure signal and the first pressure-flow correspondence or the second pressure-flow correspondence. Obtaining the unintentional leakage of the interface accessory based on the difference between the total leakage and the intentional leakage of the interface accessory includes obtaining the average flow rate of the unintentional leakage of the interface accessory based on the difference between the average flow rate of the total leakage and the average flow rate of the intentional leakage, as the unintentional leakage of the interface accessory.

[0108] The method of obtaining the total leakage based on the flow signal includes: filtering the flow signal to obtain the average flow rate of the total leakage, which is taken as the total leakage; the filtering includes low-pass filtering or adaptive filtering. Alternatively, the method of obtaining the total leakage based on the flow signal includes: extracting flow data for at least one respiratory cycle from the flow signal; and obtaining the average flow rate of the total leakage based on the average value of the flow data for at least one respiratory cycle, which is taken as the total leakage.

[0109] For example, obtaining the average flow rate of intentional leakage based on a pressure signal and a first pressure-flow correspondence or a second pressure-flow correspondence includes: filtering the pressure signal to obtain an average pressure, and obtaining the average flow rate of intentional leakage according to the average pressure and the first pressure-flow correspondence or the second pressure-flow correspondence, wherein the filtering includes low-pass filtering or adaptive filtering. Alternatively, obtaining the average flow rate of intentional leakage based on a pressure signal and the first pressure-flow correspondence or the second pressure-flow correspondence includes: extracting pressure data from at least one respiratory cycle from the pressure signal, obtaining an average pressure based on the average value of the pressure data from at least one respiratory cycle, and obtaining the average flow rate of intentional leakage according to the average pressure and the first pressure-flow correspondence or the second pressure-flow correspondence.

[0110] Alternatively, the average flow rate of the intentional leak can be obtained based on the pressure signal and the first or second pressure-flow correspondence, including: obtaining the instantaneous flow rate signal of the intentional leak according to the pressure signal and the first or second pressure-flow correspondence; filtering the instantaneous flow rate signal of the intentional leak to obtain the average flow rate of the intentional leak, wherein the filtering includes low-pass filtering or adaptive filtering.

[0111] Alternatively, the average flow rate of the intentional leak can be obtained based on the pressure signal and a first pressure-flow correspondence or a second pressure-flow correspondence, including: obtaining the instantaneous flow rate signal of the intentional leak based on the pressure signal and the first pressure-flow correspondence or the second pressure-flow correspondence; extracting instantaneous flow rate data for at least one respiratory cycle from the instantaneous flow rate signal of the intentional leak; and obtaining the average flow rate of the intentional leak based on the average value of the instantaneous flow rate data for at least one respiratory cycle extracted from the instantaneous flow rate signal of the intentional leak.

[0112] Furthermore, every first preset time interval, the average flow rate of unintentional leaks from the interface accessories within a previous second preset time interval is acquired, where the length of the first preset time interval is shorter than the length of the second preset time interval. The average flow rates of at least two unintentional leaks are averaged to obtain unintentional leak monitoring data. This unintentional leak monitoring data is compared with a preset threshold, and a prompt message is generated when the unintentional leak monitoring data exceeds the preset threshold. The lengths of the first preset time interval and / or the second preset time interval can be adjusted in real time according to the breathing status of the ventilated individual.

[0113] In another embodiment, obtaining the total leakage based on the flow signal includes: obtaining the instantaneous flow rate of the total leakage based on the flow signal. Obtaining the intentional leakage of the interface accessory based on the pressure signal and a first pressure-flow correspondence or a second pressure-flow correspondence includes: obtaining the instantaneous flow rate of the intentional leakage based on the pressure signal and the first pressure-flow correspondence or the second pressure-flow correspondence; obtaining the unintentional leakage of the interface accessory based on the difference between the total leakage and the intentional leakage includes: obtaining the instantaneous flow rate signal of the unintentional leakage based on the difference between the instantaneous flow rate of the total leakage and the instantaneous flow rate of the intentional leakage.

[0114] In some embodiments, the ventilation line further includes an expiratory valve, and the method 700 for monitoring ventilation leakage of a medical ventilation device further includes: performing a calibration procedure on the expiratory valve to obtain a pressure-flow correspondence for intentional leakage of the expiratory valve; the processor recalls the pressure-flow correspondence for intentional leakage of the expiratory valve and obtains the intentional leakage of the expiratory valve based on the pressure-flow correspondence for intentional leakage of the expiratory valve; the processor obtains the unintentional leakage of the interface accessory based on the total leakage minus the intentional leakage of the interface accessory and the intentional leakage of the expiratory valve.

[0115] Based on the above description, the method 100 for monitoring ventilation leakage of medical ventilation equipment in this application embodiment is configured with at least two pressure-flow correspondences for intentional leakage of interface accessories. The first pressure-flow correspondence or the second pressure-flow correspondence can be selected as needed to obtain the intentional leakage of the interface accessories. After obtaining the intentional leakage and the total leakage, the unintentional leakage of the interface accessories is obtained based on the difference between the total leakage and the intentional leakage of the interface accessories, thereby realizing the automatic monitoring of unintentional leakage. It can guide medical staff to adjust the tightness of the interface accessories through unintentional leakage.

[0116] See Figure 8 Another aspect of this application provides a method 800 for monitoring ventilation leaks in a medical ventilation device. The medical ventilation device includes a pressure generating device, a pressure sensor, a flow sensor, and a processor. The pressure generating device is connected to a ventilation line to deliver gas at a set pressure or flow rate to the person being ventilated. The ventilation line includes an interface accessory worn on the breathing area of ​​the person being ventilated. The processor controls the pressure generating device to generate the gas at the set pressure or flow rate. The pressure sensor is located at the interface accessory or at the device end of the medical ventilation device to measure the pressure at the interface accessory or the device end. The method 800 for monitoring ventilation leaks in a medical ventilation device specifically includes the following steps: In step S810, a calibration procedure for the exhalation valve is performed to obtain the pressure-flow correspondence of intentional leakage of the exhalation valve; In step S820, the flow signal collected by the flow sensor is acquired, and the total leakage is obtained based on the flow signal; In step S830, the pressure signal collected by the pressure sensor is acquired; In step S840, the processor determines the intentional leakage of the exhalation valve based on the pressure signal and the pressure-flow correspondence of the intentional leakage of the exhalation valve; In step S850, the processor determines the unintentional leakage of the interface accessory based on the difference between the total leakage and the intentional leakage of the exhalation valve.

[0117] The method 800 for monitoring ventilation leakage of medical ventilation equipment in this application embodiment obtains an accurate pressure-flow correspondence of intentional leakage of the expiratory valve by performing a calibration procedure on the expiratory valve, obtains the intentional leakage of the expiratory valve based on the pressure-flow correspondence of intentional leakage of the expiratory valve, and then obtains the unintentional leakage of the interface accessory based on the difference between the total leakage and the intentional leakage of the expiratory valve, thereby realizing the automatic monitoring of unintentional leakage.

[0118] During mechanical ventilation, the use of interface accessories includes those with intentional leakage and those without intentional leakage; the use of expiratory valves includes those with and without expiratory valves, and correspondingly, expressions for unintentional leakage of interface accessories include the following: When using an interface accessory with intentional leakage, and without using the exhalation valve, unintentional leakage... ,in, For the total leak, This is an intentional leak of interface attachments; When using unintentionally leaking interface accessories or exhalation valves, unintentional leakage... ,in, This is due to intentional leakage of the exhalation valve; When using interface accessories with intentional leakage or when using an exhalation valve, unintentional leakage... .

[0119] Therefore, when using an exhalation valve, the intentional leakage of the exhalation valve needs to be subtracted from the total leakage when calculating unintentional leakage. The pressure-flow correspondence between the intentional leakage of the exhalation valve and the pressure signal needs to be obtained by performing a calibration procedure on the exhalation valve to ensure that the pressure-flow correspondence of the intentional leakage of the exhalation valve matches the exhalation valve currently in use.

[0120] Specifically, during the calibration procedure for the exhalation valve, the connection between the exhalation valve and the interface accessory must be kept closed, and the exhaust port of the exhalation valve must be open. At this time, all the gas in the ventilation tubing leaks through the exhaust port of the exhalation valve; therefore, the flow rate measured by the flow sensor is the intentional leakage flow rate of the exhalation valve's exhaust port. The processor of the medical ventilation device controls the pressure generating device to provide ventilation at multiple set pressures (P1, P2…PN) and controls the flow sensor to acquire the flow rate (F1, F2…FN) corresponding to each set pressure. The processor then fits the multiple set pressures and their corresponding flow rates to obtain the pressure-flow rate correspondence of the intentional leakage of the exhalation valve. This pressure-flow rate correspondence accurately represents the relationship between the pressure in the ventilation tubing and the intentional leakage flow rate of the exhalation valve.

[0121] Since intentional leakage of the exhalation valve is calculated only when the exhalation valve is connected between the interface accessory and the ventilation line, it is also possible to display, before performing the calibration procedure for the exhalation valve to obtain the pressure-flow correspondence of intentional leakage, as shown below. Figure 9The calibration interface for the exhalation valve shown is used to receive selection commands regarding whether an exhalation valve is connected between the interface accessory and the ventilation line. The user can select whether an exhalation valve is connected or not through unit 920. When a selection command indicating that an exhalation valve is connected between the interface accessory and the ventilation line is received through the exhalation valve calibration interface, the exhalation valve calibration procedure is executed to obtain the pressure-flow correspondence of intentional leakage of the exhalation valve; otherwise, the exhalation valve calibration procedure is not executed. When selecting whether an exhalation valve is connected, it is not necessary to distinguish between different types of exhalation valves, such as side-port valves, silent valves, or platform valves.

[0122] In addition, the calibration interface of the exhalation valve also displays an operation control 910 for starting the calibration program of the exhalation valve. After connecting the ventilation line and the exhalation valve as required and blocking the connection end between the exhalation valve and the interface accessory, the user can click the operation control 910; when the processor receives the operation command for the operation control 910, it starts the calibration program of the exhalation valve.

[0123] For example, users can also choose not to perform the expiratory valve calibration procedure. During ventilation, the processor can recall the pressure-flow correspondence of the intentional leakage of the expiratory valve obtained from the previous calibration procedure to determine the intentional leakage. Hospital departments typically purchase accessories in batches, so a department may use the same type of expiratory valve from the same manufacturer for a period of time. If the manufacturer and type of the expiratory valve do not change, the pressure-flow correspondence of the intentional leakage will remain largely unchanged. Therefore, after performing the calibration procedure once, users do not need to recalibrate every time the expiratory valve is replaced. Users can perform the expiratory valve calibration procedure only when the manufacturer or type of the expiratory valve is changed. In some embodiments, the expiratory valve calibration interface can also display the calibration time and results of the previous calibration procedure, allowing users to decide whether to re-perform the calibration procedure.

[0124] In some embodiments, the calibration interface of the exhalation valve may also display calibration prompt information 930. This prompt information advises that during the calibration procedure, the exhalation valve should be properly connected, the connection between the exhalation valve and the interface accessory should be closed, and the exhaust port of the exhalation valve should remain open. The calibration prompt information 930 may include text prompts and specific graphic prompts.

[0125] As mentioned above, when the interface accessory is an intentionally leaking accessory, the intentional leakage of the interface accessory needs to be subtracted from the total leakage when calculating the unintentional leakage of the interface accessory. The calibration interface of the exhalation valve is also used to receive a selection instruction for the type of interface accessory, which includes either an interface accessory with intentional leakage or an interface accessory without intentional leakage. When a selection instruction for an interface accessory with intentional leakage is received through the calibration interface of the exhalation valve, the processor invokes the pressure-flow correspondence of the intentional leakage of the interface accessory and obtains the intentional leakage of the interface accessory based on the pressure signal and the pressure-flow correspondence of the intentional leakage of the interface accessory; the processor obtains the unintentional leakage of the interface accessory by subtracting the intentional leakage of the exhalation valve and the intentional leakage of the interface accessory from the total leakage. The pressure-flow correspondence of the intentional leakage of the interface accessory can be applied to various types of interface accessories.

[0126] Continue to refer to Figure 9 Users can select the type of interface accessory through unit 940 in the expiratory valve calibration interface. Among these, oronasal masks with exhaust vents and endotracheal tubes / tracheostomy cannulas are interface accessories with intentional leakage. Oronasal masks without exhaust vents are interface accessories without intentional leakage. Furthermore, less commonly used interface accessory types can be grouped into one category. Since it is difficult to obtain intentional leakage data for these accessories, selecting this type of accessory may only support total leakage monitoring, not intentional leakage monitoring. When the interface accessory type is selected as "Other," or the expiratory valve calibration fails, or other situations arise where unintentional leakage cannot be calculated, a message will appear in the expiratory valve calibration interface indicating that unintentional leakage cannot be monitored.

[0127] Furthermore, the calibration interface for the exhalation valve can be configured with restrictions to reduce clinical misoperation. For example, when a selection instruction for an interface accessory of type "no intentional leakage" is received through the calibration interface, the system is set to always have an exhalation valve connected between the interface accessory and the ventilation tubing, preventing the user from selecting not to use the exhalation valve. This serves as a reminder to the user that an exhalation valve must be connected for the current interface accessory type.

[0128] In some embodiments, the exhalation valve and interface accessory can also be calibrated as a whole. In this embodiment, the outlet of the interface accessory can be kept closed during calibration. For example, after connecting the exhalation valve, the interface accessory connected to the exhalation valve can be pressed onto a table to seal it; or a face-like model can be provided, and the interface accessory can be placed on the model to ensure a tight seal between the interface accessory and the model. With the outlet of the interface accessory kept closed, there is no unintentional leakage from the interface accessory, and the flow rate sensor measures the intentional leakage of the interface accessory and the exhalation valve as a whole. The processor of the medical ventilation device controls the pressure generating device to perform ventilation at multiple set pressures and controls the flow rate sensor to obtain the flow rate corresponding to each set pressure. By fitting multiple set pressures and their corresponding flow rates, the pressure-flow rate correspondence of the intentional leakage of the interface accessory and the exhalation valve as a whole can be obtained.

[0129] In one embodiment, the total leakage, intentional leakage of the exhalation valve, and unintentional leakage are both average flow rates. Specifically, obtaining the total leakage based on the flow signal includes obtaining the average flow rate of the total leakage based on the flow signal; obtaining the intentional leakage of the exhalation valve based on the pressure-flow correspondence between the pressure signal and the intentional leakage of the exhalation valve includes obtaining the average flow rate of the intentional leakage of the exhalation valve based on the pressure-flow correspondence between the pressure signal and the intentional leakage of the exhalation valve; obtaining the unintentional leakage of the interface accessory based on the difference between the total leakage and the intentional leakage of the exhalation valve includes obtaining the average flow rate of the unintentional leakage of the interface accessory based on the difference between the average flow rate of the total leakage and the average flow rate of the intentional leakage of the exhalation valve, which is used as the unintentional leakage of the interface accessory.

[0130] The average pressure can be obtained through methods such as filtering or averaging. For example, the pressure signal can be filtered to obtain the average pressure; filtering methods include low-pass filtering or adaptive filtering. Alternatively, pressure data from at least one respiratory cycle can be extracted from the pressure signal, and the average pressure can be obtained based on the average value of the pressure data from at least one respiratory cycle. After obtaining the average pressure, the average flow rate of the intentional leakage from the exhalation valve can be obtained based on the pressure-flow correspondence between the average pressure and the intentional leakage from the exhalation valve.

[0131] In some embodiments, the instantaneous flow rate signal of the intentional leakage of the exhalation valve can first be obtained based on the pressure signal and the pressure-flow rate correspondence of the intentional leakage of the exhalation valve. Then, the instantaneous flow rate signal of the intentional leakage of the exhalation valve is filtered to obtain the average flow rate of the intentional leakage of the exhalation valve, wherein the filtering includes low-pass filtering or adaptive filtering; or, instantaneous flow rate data for at least one respiratory cycle is extracted from the instantaneous flow rate signal of the intentional leakage of the exhalation valve, and the average flow rate of the intentional leakage of the exhalation valve is obtained based on the average value of the instantaneous flow rate data for at least one respiratory cycle extracted from the instantaneous flow rate signal of the intentional leakage of the exhalation valve.

[0132] In other embodiments, the total leakage, intentional leakage of the exhalation valve, and unintentional leakage are all instantaneous flow rates. Specifically, obtaining the total leakage based on the flow signal includes obtaining the instantaneous flow rate of the total leakage based on the flow signal; obtaining the intentional leakage of the exhalation valve based on the pressure signal and the pressure-flow rate correspondence of the intentional leakage of the exhalation valve includes obtaining the instantaneous flow rate of the intentional leakage of the exhalation valve based on the pressure-flow rate correspondence of the pressure signal and the intentional leakage of the exhalation valve; obtaining the unintentional leakage of the interface accessory based on the difference between the total leakage and the intentional leakage of the exhalation valve includes obtaining the instantaneous flow rate signal of the unintentional leakage of the interface accessory based on the difference between the instantaneous flow rate of the total leakage and the instantaneous flow rate of the intentional leakage of the exhalation valve.

[0133] Based on the above description, the method 100 for monitoring ventilation leakage of medical ventilation equipment in this application embodiment is configured with at least two pressure-flow correspondences for intentional leakage of interface accessories. The first pressure-flow correspondence or the second pressure-flow correspondence can be selected as needed to obtain the intentional leakage of the interface accessories. After obtaining the intentional leakage and the total leakage, the unintentional leakage of the interface accessories is obtained based on the difference between the total leakage and the intentional leakage of the interface accessories, thereby realizing the automatic monitoring of unintentional leakage. It can guide medical staff to adjust the tightness of the interface accessories through unintentional leakage.

[0134] See Figure 10 Another aspect of this application provides a method 1000 for monitoring ventilation leaks in a medical ventilation device. The medical ventilation device includes a pressure generating device, a pressure sensor, a flow sensor, and a processor. The pressure generating device is connected to a ventilation line to deliver gas at a set pressure or flow rate to the person being ventilated. The ventilation line includes an interface accessory worn on the breathing area of ​​the person being ventilated. The processor controls the pressure generating device to generate the gas at the set pressure or flow rate. The pressure sensor is located at the interface accessory or at the device end of the medical ventilation device to measure the pressure at the interface accessory or the device end. The method 1000 for monitoring ventilation leaks in a medical ventilation device specifically includes the following steps: In step S1010, the flow signal collected by the flow sensor is acquired, and the total leakage is obtained based on the flow signal; In step S1020, the pressure signal collected by the pressure sensor is acquired, the pre-configured pressure-flow correspondence of intentional leakage of the interface accessory is called, and the intentional leakage of the interface accessory is obtained based on the pressure signal and the pressure-flow correspondence. The pressure-flow correspondence is applicable to various types of interface accessories. In step S1030, the unintentional leakage of the interface accessory is obtained based on the difference between the total leakage and the intentional leakage of the interface accessory.

[0135] The method 1000 for monitoring ventilation leaks in a medical ventilation device according to an embodiment of this application pre-configures a pressure-flow rate correspondence for intentional leaks in various types of interface accessories within the medical ventilation device. Intentional leaks in the interface accessories are obtained based on this correspondence, eliminating the need for the user to select an applicable pressure-flow rate correspondence. After obtaining the intentional leaks and the total leak, the unintentional leaks in the interface accessories are obtained based on the difference between the total leak and the intentional leaks of the interface accessories. This achieves automatic monitoring of unintentional leaks and allows medical personnel to adjust the tightness of the interface accessories based on unintentional leaks. The pressure-flow rate correspondence for intentional leaks in various types of interface accessories configured in the medical ventilation device can be at least one. Further details of the method 1000 for monitoring ventilation leaks in a medical ventilation device according to an embodiment of this application can be found in the relevant description of the method 100.

[0136] Reference Figure 11 This application also provides a medical ventilation device, which includes medical devices with ventilation functions such as ventilators, anesthesia machines, and oxygen therapy machines. The medical ventilation device is used to replace, control, or alter the physiological breathing of the ventilated individual, improving the respiratory function and reducing respiratory consumption by increasing lung ventilation. The medical ventilation device 1100 can be used to implement the methods 100, 700, 800, or 1000 described above for monitoring ventilation leaks in medical ventilation devices. The following only describes the main functions of the medical ventilation device 1100; other specific details can be found above.

[0137] like Figure 11 As shown, the medical ventilation device 1100 includes a pressure generating device 1110, a pressure sensor 1120, a flow sensor 1130, and a processor 1140. The pressure generating device 1110 is used to communicate with a ventilation tubing, which is used to connect to an interface accessory worn on the breathing area of ​​the ventilated individual to deliver gas at a set pressure or flow rate to the ventilated individual through the ventilation tubing and the interface accessory. In some embodiments, an exhalation valve is also connected between the ventilation tubing and the interface accessory. The pressure generating device 1110 includes a turbine, a gas cylinder, etc. The interface accessory includes a face mask, a nasal mask, a head cover, etc. The pressure sensor 1120 is used to measure the pressure at the interface accessory, and the flow sensor 1130 is used to measure the gas flow rate in the ventilation tubing. In one example, the pressure sensor 1120 is located at the interface accessory, and the flow sensor 1130 is located at the device end of the medical ventilation device; in other examples, the pressure sensor 1120 may also be located at the device end of the medical ventilation device.

[0138] Pressure sensor 1120 and flow sensor 1130 are communicatively connected to processor 1140 and send the measured signals to processor 1140. Processor 1140 controls the pressure generating device to produce gas at a set pressure or flow rate. Processor 1140 is also used to execute the methods 100, 700, 800, or 1000 described above for monitoring ventilation leaks in medical ventilation equipment, to monitor unintentional leaks at the contact surface between the interface accessory and the ventilated object. Further details of methods 100, 700, 800, or 1000 for monitoring ventilation leaks in medical ventilation equipment can be found above and will not be repeated here.

[0139] The medical ventilation device 1100 of this application embodiment can realize automatic monitoring of unintentional leakage of interface accessories and guide medical staff to adjust the tightness of the interface accessories.

[0140] Although exemplary embodiments have been described herein with reference to the accompanying drawings, it should be understood that the above exemplary embodiments are merely illustrative and are not intended to limit the scope of this application. Various changes and modifications can be made therein by those skilled in the art without departing from the scope and spirit of this application. All such changes and modifications are intended to be included within the scope of this application as claimed in the appended claims.

[0141] Those skilled in the art will recognize that the units and algorithm steps of the various examples described in conjunction with the embodiments disclosed herein can be implemented in electronic hardware, or a combination of computer software and electronic hardware. Whether these functions are implemented in hardware or software depends on the specific application and design constraints of the technical solution. Those skilled in the art can use different methods to implement the described functions for each specific application, but such implementation should not be considered beyond the scope of this application.

[0142] In the several embodiments provided in this application, it should be understood that the disclosed devices and methods can be implemented in other ways. For example, the device embodiments described above are merely illustrative. For instance, the division of units is only a logical functional division, and in actual implementation, there may be other division methods. For example, multiple units or components may be combined or integrated into another device, or some features may be ignored or not executed.

[0143] Numerous specific details are set forth in the specification provided herein. However, it will be understood that embodiments of this application may be practiced without these specific details. In some instances, well-known methods, structures, and techniques have not been shown in detail so as not to obscure the understanding of this specification.

[0144] Similarly, it should be understood that, in order to streamline this application and aid in understanding one or more of the various inventive aspects, features of this application may sometimes be grouped together in a single embodiment, figure, or description thereof in the description of exemplary embodiments of this application. However, this approach should not be construed as reflecting an intention that the claimed application requires more features than are expressly recited in each claim. Rather, as reflected in the corresponding claims, its inventive point lies in solving the corresponding technical problem with features fewer than all features of a single disclosed embodiment. Therefore, the claims following the detailed description are hereby expressly incorporated into that detailed description, wherein each claim itself is a separate embodiment of this application.

[0145] Those skilled in the art will understand that, apart from the mutual exclusion of features, all features disclosed in this specification (including the accompanying claims, abstract, and drawings) and all processes or elements of any method or apparatus so disclosed may be combined in any combination. Unless otherwise expressly stated, each feature disclosed in this specification (including the accompanying claims, abstract, and drawings) may be replaced by an alternative feature that serves the same, equivalent, or similar purpose.

[0146] Furthermore, those skilled in the art will understand that although some embodiments described herein include certain features but not others included in other embodiments, combinations of features from different embodiments are intended to be within the scope of this application and form different embodiments. For example, in the claims, any one of the claimed embodiments can be used in any combination.

[0147] The various component embodiments of this application can be implemented in hardware, or as software modules running on one or more processors, or a combination thereof. Those skilled in the art will understand that microprocessors or digital signal processors (DSPs) can be used in practice to implement some or all of the functions of some modules according to the embodiments of this application. This application can also be implemented as an apparatus program (e.g., a computer program and computer program product) for performing part or all of the methods described herein. Such an implementation of this application can be stored on a computer-readable medium, or can be in the form of one or more signals. Such signals can be downloaded from an Internet website, provided on a carrier signal, or provided in any other form.

[0148] It should be noted that the above embodiments are illustrative of this application and not limiting of it, and that those skilled in the art can devise alternative embodiments without departing from the scope of the appended claims. In the claims, any reference signs placed between parentheses should not be construed as limiting the claims. This application can be implemented by means of hardware comprising several different elements and by means of a suitably programmed computer. In the unit claims enumerating several means, several of these means may be embodied by the same item of hardware. The use of the words first, second, and third, etc., does not indicate any order. These words can be interpreted as names.

[0149] The above description is merely a specific embodiment or illustration of the embodiments of this application. The scope of protection of this application is not limited thereto. Any variations or substitutions that can be easily conceived by those skilled in the art within the scope of the technology disclosed in this application should be included within the scope of protection of this application. The scope of protection of this application shall be determined by the scope of the claims.

Claims

1. A medical ventilation device, characterized in that, include: A pressure generating device is used to communicate with a ventilation line, the ventilation line being used to connect to an interface accessory worn on the breathing part of the ventilated object, and an exhalation valve is also connected between the ventilation line and the interface accessory. Pressure sensor, used to collect pressure signals; Flow sensors are used to collect flow signals; as well as A processor, configured to control the pressure generating device to generate gas at a set pressure or a set flow rate, and the processor being configured to: Perform a calibration procedure on the exhalation valve to obtain the pressure-flow correspondence of intentional leakage of the exhalation valve; The flow signal collected by the flow sensor is acquired, and the total leakage is obtained based on the flow signal; Acquire the pressure signal collected by the pressure sensor; The intentional leakage of the exhalation valve is determined based on the pressure signal and the pressure-flow correspondence of the intentional leakage of the exhalation valve. The unintentional leakage of the interface accessory is determined based on the difference between the total leakage and the intentional leakage of the exhalation valve.

2. The medical ventilation device according to claim 1, characterized in that, The processor executes a calibration procedure for the exhalation valve to obtain the pressure-flow correspondence for intentional leakage of the exhalation valve, including: With the connection between the exhalation valve and the interface accessory closed and the exhaust port of the exhalation valve open, the pressure generating device is controlled to ventilate at multiple set pressures, and the flow sensor is controlled to acquire the flow rate corresponding to each set pressure. By fitting the multiple set pressures and their corresponding flow rates, the pressure-flow rate correspondence of the intentional leakage of the exhalation valve is obtained.

3. The medical ventilation device according to claim 1, characterized in that, The medical ventilation device also includes a display, and the processor is further configured to: before executing the calibration procedure for the expiratory valve, control the display to show a calibration interface for the expiratory valve, the calibration interface for receiving a selection instruction on whether an expiratory valve is connected between the interface accessory and the ventilation tubing; when a selection instruction on whether an expiratory valve is connected between the interface accessory and the ventilation tubing is received through the calibration interface for the expiratory valve, execute the calibration procedure for the expiratory valve.

4. The medical ventilation device according to claim 3, characterized in that, The calibration interface of the exhalation valve also displays operation controls for starting the calibration program of the exhalation valve. When the calibration interface of the exhalation valve receives a selection command for the exhalation valve connected between the interface accessory and the ventilation line, and receives the operation command to start the operation, the calibration program of the exhalation valve is started.

5. The medical ventilation device according to claim 3, characterized in that, The processor is further configured to: display the calibration time and calibration result of the previous calibration procedure for the exhalation valve in the calibration interface of the exhalation valve, and / or display calibration prompt information in the calibration interface of the exhalation valve, wherein the calibration prompt information is used to prompt that during the calibration procedure of the exhalation valve, the connection end between the exhalation valve and the interface accessory should be closed and the exhaust port of the exhalation valve should be kept open.

6. The medical ventilation device according to claim 3, characterized in that, The calibration interface of the exhalation valve is also used to receive a selection instruction for the type of the interface accessory, wherein the type of the interface accessory includes an interface accessory with intentional leakage or an interface accessory without intentional leakage; the processor is also used to: when receiving a selection instruction for the type of the interface accessory as an interface accessory with intentional leakage, invoke a pre-configured pressure-flow correspondence for intentional leakage of the interface accessory, obtain the intentional leakage of the interface accessory based on the pressure signal, and obtain the unintentional leakage of the interface accessory by subtracting the intentional leakage of the exhalation valve and the intentional leakage of the interface accessory from the total leakage.

7. The medical ventilation device according to claim 6, characterized in that, The processor is also configured to: when receiving a selection instruction for the interface accessory of type "no intentional leakage", fix the interface accessory to be connected to the ventilation line with an exhalation valve.

8. The medical ventilation device according to any one of claims 1-7, characterized in that, The processor obtains the total leakage based on the flow signal, including: obtaining the average flow rate of the total leakage based on the flow signal; The processor obtains the intentional leakage of the exhalation valve based on the pressure signal and the pressure-flow correspondence of the intentional leakage of the exhalation valve, including: obtaining the average flow rate of the intentional leakage of the exhalation valve based on the pressure signal and the pressure-flow correspondence of the intentional leakage of the exhalation valve; The processor determines the unintentional leakage of the interface accessory based on the difference between the total leakage and the intentional leakage of the exhalation valve, including: determining the average flow rate of the unintentional leakage of the interface accessory based on the difference between the average flow rate of the total leakage and the average flow rate of the intentional leakage of the exhalation valve.

9. The medical ventilation device according to claim 1, characterized in that, The processor obtains the total leakage based on the flow signal, including: The average flow rate of the total leakage is obtained by low-pass filtering or adaptive filtering of the flow signal, and is taken as the total leakage; or, flow data of at least one respiratory cycle is extracted from the flow signal, and the average flow rate of the total leakage is obtained based on the average value of the flow data of the at least one respiratory cycle, and is taken as the total leakage.

10. The medical ventilation device according to claim 1, characterized in that, The processor determines the intentional leakage of the exhalation valve based on the pressure signal and the pressure-flow correspondence of the intentional leakage of the exhalation valve, including: The average pressure is obtained by low-pass filtering or adaptive filtering of the pressure signal, and the average flow rate of the intentional leakage of the exhalation valve is obtained according to the correspondence between the average pressure and the pressure-flow rate of the intentional leakage of the exhalation valve. Alternatively, pressure data for at least one respiratory cycle can be extracted from the pressure signal, an average pressure can be obtained based on the average value of the pressure data for the at least one respiratory cycle, and an average flow rate for intentional leakage of the exhalation valve can be obtained based on the average pressure and the pressure-flow rate correspondence.

11. The medical ventilation device according to any one of claims 1-7, characterized in that, The processor obtains the total leakage based on the flow signal, including: obtaining the instantaneous flow rate of the total leakage based on the flow signal; The processor obtains the intentional leakage of the exhalation valve based on the pressure signal and the pressure-flow correspondence of the intentional leakage of the exhalation valve, including: obtaining the instantaneous flow rate of the intentional leakage of the exhalation valve based on the pressure signal and the pressure-flow correspondence of the intentional leakage of the exhalation valve; The processor obtains the unintentional leakage of the interface accessory based on the difference between the total leakage and the intentional leakage of the exhalation valve, including: obtaining the instantaneous flow signal of the unintentional leakage of the interface accessory based on the difference between the instantaneous flow rate of the total leakage and the instantaneous flow rate of the intentional leakage of the interface accessory.

12. The medical ventilation device according to claim 1, characterized in that, The processor is also configured to: every first preset time interval, acquire the average unintentional leakage traffic of the interface attachment during a previous second preset time interval, wherein the length of the first preset time interval is less than the length of the second preset time interval; The average flow rate of at least two unintentional leaks is averaged to obtain monitoring data of unintentional leaks; the monitoring data of unintentional leaks is compared with a preset threshold, and a prompt message is generated when the monitoring data of unintentional leaks exceeds the preset threshold.

13. The medical ventilation device according to claim 12, characterized in that, The processor is also configured to adjust the length of the first preset time and / or the second preset time in real time according to the breathing state of the ventilated object.

14. The medical ventilation device according to claim 1, characterized in that, The processor is also configured to display the unintentional leakage of the interface accessory in the form of an instrument graphic, the instrument graphic including the current value of the unintentional leakage, an indicator bar, and a pointer, the indicator bar being used to indicate the range of the unintentional leakage, and the pointer being used to point to the position of the current value of the unintentional leakage within the range.

15. A method for monitoring ventilation leakage in a medical ventilation device, the medical ventilation device comprising a pressure generating device, a pressure sensor, a flow sensor, and a processor, wherein the pressure generating device is configured to communicate with a ventilation tubing, the ventilation tubing being connected to an interface accessory worn on the breathing part of a person being ventilated, for delivering gas at a set pressure or a set flow rate to the person being ventilated through the ventilation tubing and the interface accessory, and an exhalation valve is further connected between the interface accessory and the ventilation tubing; the processor is configured to control the pressure generating device to generate the gas at the set pressure or set flow rate, characterized in that... The method includes: Perform a calibration procedure on the exhalation valve to obtain the pressure-flow correspondence of intentional leakage of the exhalation valve; The flow signal collected by the flow sensor is acquired, and the total leakage is obtained based on the flow signal; Acquire the pressure signal collected by the pressure sensor; The processor determines the intentional leakage of the exhalation valve based on the pressure signal and the pressure-flow correspondence of the intentional leakage of the exhalation valve; The processor determines the unintentional leakage of the interface accessory based on the difference between the total leakage and the intentional leakage of the exhalation valve.

16. A method for monitoring ventilation leakage in a medical ventilation device, the medical ventilation device comprising a pressure generating device, a pressure sensor, a flow sensor, and a processor, the pressure generating device being configured to communicate with a ventilation line, the ventilation line being configured to connect to an interface accessory worn on the breathing part of a person being ventilated, for delivering gas at a set pressure or a set flow rate to the person being ventilated via the ventilation line and the interface accessory, the ventilation line including the interface accessory worn on the breathing part of the person being ventilated, the processor being configured to control the pressure generating device to generate the gas at the set pressure or set flow rate, characterized in that... The method includes: The flow signal collected by the flow sensor is acquired, and the total leakage is obtained based on the flow signal; The pressure signal collected by the pressure sensor is acquired, the pressure-flow correspondence of the pre-configured interface accessory for intentional leakage is invoked, and the intentional leakage of the interface accessory is obtained based on the pressure signal and the pressure-flow correspondence. The pressure-flow correspondence is applicable to various types of interface accessories. The unintentional leakage of the interface attachment is obtained based on the difference between the total leakage and the intentional leakage of the interface attachment.

17. The method according to claim 1, characterized in that, The pre-configured pressure-flow correspondence for the intentionally leaked interface accessory is uniquely configured in the medical ventilation device; Alternatively, the pre-configured pressure-flow correspondence for intentional leakage of the interface accessory is a first pressure-flow correspondence, and the method includes: during the ventilation process of the medical ventilation device, obtaining a second pressure-flow correspondence for intentional leakage of the interface accessory; the second pressure-flow correspondence is different from the first pressure-flow correspondence; the processor invokes the second pressure-flow correspondence, and based on the pressure signal and the second pressure-flow correspondence, obtains the intentional leakage of the interface accessory worn on the breathing part of the ventilated object; and obtains the unintentional leakage of the interface accessory based on the difference between the total leakage and the intentional leakage of the interface accessory.

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