Method and device for synchronously controlling aerosol dose based on respiratory phase recognition

Abstract

This invention discloses a method and apparatus for nebulized dose synchronization control based on respiratory phase recognition, relating to the field of respiratory phase recognition technology. Specifically, it includes: setting up a dose storage space to isolate the nebulization process from the user's inhalation and release airway, allowing aerosols to be temporarily stored and metered within the dose storage space to form a quantitative nebulized dose unit; when the inhalation initiation phase is detected and the inhalation drive signal reaches the release threshold, controlling the corresponding dose storage space to connect with the inhalation pathway, allowing the quantitative nebulized dose unit to be released with the inhalation airflow; metering the actual delivered dose during release, and performing effectiveness correction on the undelivered residual aerosol after release, using the effective residual dose as the initial dose for the next aerosol formation in that space; determining the subsequent supplementary dose based on the target delivery dose, the cumulative actual delivery dose, and the underdelivered amount, achieving alternating storage and release of different dose storage spaces, improving the synchronization and delivery accuracy of nebulized drug delivery.

Description

Technical Field

[0001] This invention belongs to the field of respiratory phase recognition technology, specifically relating to a method and device for synchronous control of nebulized dose based on respiratory phase recognition. Background Technology

[0002] Nebulized drug delivery is a common method of administration in the treatment of respiratory diseases. It typically uses a vibrating screen nebulizer, compressed air nebulizer, or ultrasonic nebulizer to convert liquid medication into an aerosol, which is then inhaled into the respiratory tract. Most existing nebulizers employ continuous nebulization output or simple breath-triggered output, meaning the nebulizer continuously generates aerosol for a set time, or directly activates the nebulizer or releases airflow after detecting inhalation, allowing the aerosol to enter the user's inhalation pathway.

[0003] However, users' breathing rhythm, inspiratory intensity, and inspiratory duration often fluctuate significantly. Continuous nebulization can easily lead to aerosol waste during the expiratory phase, inspiratory interval, or weak inspiratory phase, resulting in the actual dose entering the inhalation pathway being lower than the theoretical output dose. Although simple breathing triggering can reduce waste to some extent, it usually still relies on the instantaneous output of the nebulizer. Nebulization generation, aerosol delivery, and the user's inhalation process are synchronously coupled, making it difficult to pre-establish a stable and measurable unit dose before the start of inhalation.

[0004] Furthermore, existing technologies typically estimate the dosage based on the nebulizer's operating time, theoretical nebulization output, or drug consumption, which fails to accurately reflect whether the aerosol actually enters the inhalation pathway within the effective inhalation phase. When the user terminates inhalation prematurely, the inhalation flow is insufficient, or the airflow direction fluctuates, only a portion of the released aerosol may enter the inhalation pathway, with the remainder remaining in the tubing or cavity. Existing devices typically do not perform spatial binding, effectiveness correction, or subsequent dose offsetting for this undelivered residual aerosol, easily leading to duplicate dose replenishment, wasted residual dose, or deviations in the actual delivered dose.

[0005] Meanwhile, in scenarios requiring multiple inhalations to deliver a target dose, existing nebulization control methods often lack a closed-loop correction mechanism based on the actual delivered dose. When a single inhalation fails to deliver the predetermined dose, the device struggles to determine the source and magnitude of the under-delivery, and it also struggles to rationally allocate this under-delivery dose to subsequent nebulization units for rolling compensation. Directly extending the nebulization time or immediately adding more nebulizers may lead to problems such as respiratory phase mismatch, over-release, or increased drug deposition.

[0006] Therefore, there is an urgent need for a method and device for nebulized dose synchronization control based on respiratory phase recognition to solve the above problems. Summary of the Invention

[0007] The purpose of this invention is to provide a method and device for synchronous control of nebulized dose based on respiratory phase recognition, which solves the technical problems in the prior art, such as direct coupling between nebulization and inhalation release processes, difficulty in forming a stable quantitative dose unit in aerosols before inhalation, difficulty in accurately reflecting the actual delivered dose in theoretical nebulization output, and inability to roll over and compensate for underdelivered dose when the user terminates inhalation prematurely.

[0008] To achieve the above objectives, the present invention adopts the following technical solution: A nebulizer dose synchronization control method based on respiratory phase recognition includes: S1. During a single nebulized drug delivery process, a dose storage space is set up to isolate the nebulization generation from the inhalation and release gas path, so that the aerosol generated by the nebulizer is temporarily stored in at least one dose storage space independent of the user's inhalation path, forming a quantitative nebulized dose unit to be released by inhalation. S2. When the inhalation start phase is detected and the inhalation drive signal reaches the release threshold, the dose storage space of the quantitative nebulized dose unit that has been formed to be released by inhalation is switched to the release state connected to the user's inhalation pathway, so that the quantitative nebulized dose unit enters the inhalation pathway with the inhalation airflow. S3. Measure the amount of aerosol delivered from the dose storage space into the inhalation pathway in the release state to obtain the actual delivered dose. When the actual delivered dose reaches the release dose of the current unit, the inhalation termination phase is detected, or the inhalation drive signal is lower than the maintenance threshold, the release is terminated and the airway isolation is restored, so that the effective residual dose corresponding to the undelivered residual aerosol is included in the initial dose when the dose storage space forms a metered nebulized dose unit for the next time. S4. Based on the target delivery dose, the cumulative actual delivery dose, the initial dose of each dose storage space, and the difference between the current unit release dose and the actual delivery dose, determine the supplementary dose of the subsequent quantitative nebulization dose unit, and make different dose storage spaces alternately complete isolated metering storage and inhalation-triggered release until the cumulative actual delivery dose reaches the target delivery dose.

[0009] Furthermore, when forming a quantitative nebulized dose unit to be released by inhalation, the effective residual dose bound to the dose storage space is used as the initial dose, and the target cluster dose is determined according to the target unit dose, the current remaining delivery dose, and the amount of underdelivery to be compensated; the nebulizer is controlled to input aerosol into the dose storage space which is in a gas path isolation state until the dose in the space reaches the target cluster dose, then the input is stopped and the space is closed.

[0010] Furthermore, during the transition from any dose storage space to the release state, the direct output of the nebulizer to the user's inhalation pathway is blocked, and only the release path between the dose storage space in the release state and the user's inhalation pathway is opened; when there is no dose storage space with a pre-formed quantitative nebulized dose unit, release is prohibited by directly connecting the nebulizer to the user's inhalation pathway.

[0011] Furthermore, during the release path opening period, the aerosol subsequently generated by the nebulizer is introduced into another dose storage space that is in a gas path isolation state, so that the inhalation release process of the current quantitative nebulizer unit and the isolation formation process of the next quantitative nebulizer unit can be carried out in parallel in different dose storage spaces.

[0012] Furthermore, a dose status record is established for each dose storage space and bound to its space identifier. The dose status record includes the stored dose, effective residual dose, dose to be released, and current gas path status. After the release of any dose storage space, the effective residual dose that was not delivered continues to be bound to the dose storage space and serves as the initial dose when the space forms a quantitative nebulization dose unit for the next time.

[0013] Furthermore, after the release path is closed, the residual dose is determined based on the difference between the pre-release dose value and the actual delivered dose, and the residual dose is effectively corrected based on at least one of the following: residence time of aerosol in the dose storage space, deposition distribution, concentration decay, or change in space pressure, to obtain an effective residual dose.

[0014] Furthermore, when the release path closes before the current unit release dose is reached due to the detection of an inspiratory termination phase or an inspiratory drive signal below the maintenance threshold, the difference between the current unit release dose and the actual delivered dose is determined as the underdelivery amount, and the underdelivery amount is allocated to the dose storage space in the isolation formation state or the next time the isolation formation state is entered for rolling compensation.

[0015] Furthermore, when determining the supplementary dose for subsequent quantitative nebulization dose units, the supplementary requirement is determined by combining the under-delivery amount, the remaining amount of the target delivery dose, and the effective residual dose locked in each dose storage space; for dose storage spaces with effective residual dose, the supplementary requirement is first deducted by the effective residual dose, and then the nebulizer is controlled to replenish the difference dose.

[0016] Furthermore, during the period of release in one dose storage space and replenishment in another dose storage space, the difference dose in the replenishment space is corrected based on the actual delivery dose updated in real time in the release space; when the corrected difference dose is replenished, the replenishment space reaches the corrected target cluster dose, or the cumulative actual delivery dose reaches the target delivery dose, replenishment is stopped and the replenishment space is closed.

[0017] The present invention also provides a nebulized dose synchronization control device based on respiratory phase recognition, which is applied to the nebulized dose synchronization control method based on respiratory phase recognition. The device is characterized in that it includes: a nebulizer, at least two dose storage spaces, a user inhalation passage, a gas path switching component, a respiratory detection component, a dose detection component, and a controller. The controller includes: An isolation metering storage module is used to control at least one dose storage space to be isolated from the user's inhalation pathway, and to allow the aerosol generated by the nebulizer to enter the dose storage space for metering and storage, forming a quantitative nebulized dose unit to be released upon inhalation. The inspiratory phase-triggered release module is used to identify the inspiratory initiation phase based on the inspiratory drive signal generated by the respiratory detection component, and when the inspiratory drive signal reaches the release threshold, it controls the dose storage space of the pre-formed quantitative nebulized dose unit to connect with the user's inhalation pathway, so that the quantitative nebulized dose unit is released with the inspiratory airflow. The actual delivery and residual locking module is used to measure the actual delivered dose into the user's inhalation pathway according to the dose detection component during the release state, and to restore the airway isolation after the release is completed, and bind the undelivered residual aerosol as the effective residual dose to the original dose temporary storage space after effectiveness correction. The subsequent supplement and alternation control module is used to determine the subsequent supplement dose based on the target delivery dose, the cumulative actual delivery dose, the initial dose of each dose storage space, and the difference between the current unit release dose and the actual delivery dose, and to control different dose storage spaces to alternately complete isolated metering storage and inhalation-triggered release.

[0018] In summary, due to the adoption of the above technical solution, the beneficial effects of the present invention are: 1. This invention sets up at least two dose storage spaces that are isolated from each other by air path, so that the aerosol generated by the nebulizer first forms a quantitative nebulized dose unit in the dose storage space, and then is released after the inhalation start phase is detected, thereby decoupling the nebulization process from the inhalation release process and reducing ineffective release during the exhalation or inhalation interval.

[0019] 2. By measuring the aerosol flux that meets the conditions of open release path, maintained inhalation drive signal, correct airflow direction and closed straight path in the release state, the present invention can make the cumulative dose closer to the actual dose entering the inhalation pathway, rather than estimating it based solely on the working time of the nebulizer or the theoretical output.

[0020] 3. This invention binds the effective residual dose after release to the original dose storage space and deducts it first when forming a quantitative nebulized dose unit. At the same time, it performs rolling compensation based on the under-delivery amount, which can reduce the dose deviation caused by repeated replenishment and accumulation of under-delivery. By alternately executing isolated metering storage and inhalation-triggered release in different dose storage spaces, the continuity of drug administration and dose synchronization are improved in scenarios where the target drug dose is completed by multiple inhalations. Attached Figure Description

[0021] To more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0022] Figure 1 The following diagram illustrates the steps of the nebulization dose synchronization control method based on respiratory phase recognition of the present invention. Figure 2 A flowchart of the method for release dose measurement and residual dose locking of the present invention is shown; Figure 3 A block diagram of the nebulization dose synchronization control device based on respiratory phase recognition of the present invention is shown. Detailed Implementation

[0023] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0024] This embodiment provides a method and apparatus for nebulized dose synchronization control based on respiratory phase recognition. The apparatus includes a nebulizer, at least two dose storage spaces, a user inhalation pathway, a gas path switching component, a respiratory detection component, a dose detection component, and a controller.

[0025] The at least two dose temporary storage spaces are respectively denoted as the i-th dose temporary storage space, where And n≥2. Each dose storage space can be selectively connected to the nebulizer, the user's inhalation pathway, or both, under the control of the controller.

[0026] The air path switching assembly includes an input valve, a release valve, and an isolation valve. The controller controls the opening and closing of each valve, causing the aerosol generated by the nebulizer to first enter the dose storage space, which is in an air path isolation state, for metering and storage, forming a quantitative nebulized dose unit, instead of directly entering the user's inhalation pathway.

[0027] The controller establishes a dose status record for each dose storage space. The dose status record includes space identifier, airway status, stored dose, effective residual dose, dose to be released, and whether a quantitative nebulized dose unit has been formed. At the start of a nebulized drug delivery, the cumulative actual delivered dose, underdelivered dose, and effective residual dose of each dose storage space are initialized to zero, and the direct airway between the nebulizer and the user's inhalation pathway is closed.

[0028] Example 1, such as Figure 1 The nebulizer dose synchronization control method based on respiratory phase recognition shown includes the following steps: S1. During a single nebulized drug delivery process, a dose storage space is set up to isolate the nebulization generation from the inhalation and release gas path, so that the aerosol generated by the nebulizer is temporarily stored in at least one dose storage space independent of the user's inhalation path, forming a quantitative nebulized dose unit to be released by inhalation. During a single nebulized drug delivery, the controller selects at least one dose storage space that is in a gas path isolation state as the target storage space. Taking the i-th dose storage space as an example, the controller closes the release path between this space and the user's inhalation pathway, and only opens the input path from the nebulizer to this storage space. The aerosol generated by the nebulizer then enters the space to complete the metering storage. In this state, the nebulizer and the user's inhalation pathway are not connected, and the target storage space and the user's inhalation pathway also maintain gas path isolation, achieving gas path separation between the nebulization process and the inhalation-release process.

[0029] Before forming a quantitative nebulization dose unit, the dose parameters for this nebulization drug delivery process are set, and the target delivery dose is defined as follows. The cumulative actual delivered dose was ; This refers to the cumulative target dose that actually needs to enter the user's inhalation pathway during nebulized drug delivery. This target delivery dose can be determined by the prescribed dosage, drug concentration, preset treatment plan, or the dosing level input by the user. If the prescription is expressed in terms of drug mass, drug volume, or nebulization time, the controller first converts it into the cumulative aerosol dose that needs to be delivered into the inhalation pathway and uses it as the target delivery dose for this drug delivery process.

[0030] For example, the target delivery dose can be determined according to the following unweighted structure:

[0031] in, The target dose corresponding to the prescription and treatment plan. This represents the upper limit of the safe dose allowed for a single administration. This is the upper limit of the dose that the device is allowed to deliver under the current drug solution and operating mode.

[0032] This refers to the cumulative aerosol dose that has actually entered the user's inhalation pathway during this administration process. It is not a preset value, but is updated sequentially based on the actual delivered dose detected by the dose detection component after each release from the dose storage space.

[0033] At the start of a new nebulization administration cycle, the controller initializes the cumulative actual delivered dose to zero. After each release, the controller adds the actual delivered dose to the cumulative actual delivered dose. In other words, the cumulative actual delivered dose reflects the dose that has actually been delivered to the inhalation pathway, not the dose already generated by the nebulizer or the dose that has been stored in the dose buffer.

[0034] Before forming a quantitative nebulization dose unit, the controller reads the dose status record from the target temporary storage space.

[0035] The preset unit dose is a single-dose quantitative release baseline value determined by the controller based on the target delivery dose, expected number of releases, the user's per-inhalation dose capacity, and the upper limit of the dose storage space capacity. The upper limit of the single dose storage space capacity is the maximum temporary dose that can be stored in the space under the conditions of maintaining a sealed gas path, stable pressure, aerosol concentration within the release range, and meeting the safety limits for a single inhalation.

[0036] The amount of underdelivered dose to be compensated is zero at the start of a single nebulization. After any dose storage space is released, if the actual delivered dose is less than the dose released by the current unit, the undelivered dose portion is taken as the amount of underdelivered dose to be compensated, and rolling compensation is performed when a quantitative nebulization dose unit is formed in the dose storage space under gas path isolation state in the future.

[0037] Set the current remaining delivery dose to ,correspond ,in The rule for determining the value is: when x is greater than 0, take x; otherwise, take 0. If there is a locked effective residual dose in the i-th dose temporary storage space... For dose storage spaces participating in this dosing process for the first time, the effective residual dose is zero; for dose storage spaces that have already undergone a release process, the effective residual dose is the residual dose that has been corrected and locked after the last release in that space. The effective residual dose serves as the initial dose for the current formation of a quantitative nebulization dose unit in that dose storage space.

[0038] This serves as the initial dose for constructing the quantitative nebulization dosing unit in this space. The controller, considering the current remaining delivery dose, the preset unit dose, the maximum capacity of a single temporary storage space, and the amount of under-delivery to be compensated, calculates the target clump dose using the following formula:

[0039] in The target cluster dose to be formed in this temporary dose storage space is the i-th dose. For the preset unit dose, The maximum temporary dose that can be stored in a single dose storage space. This represents the amount of undelivered goods to be compensated.

[0040] The difference in dose that needs to be replenished by the nebulizer in the i-th dose storage space is denoted as . The effective residual dose remains bound to the original dose storage space and is preferentially used to offset the dose required for the next quantitative nebulization dose unit to be formed in that space.

[0041] When the atomizer inputs aerosol into the i-th dose storage space, the controller measures the supplementary dose based on the input path status, atomization output, and effective transmission coefficient:

[0042] in, The temporary storage space for the i-th dose has been filled with dose. The input path gating state is open when the i-th dose storage space is selected as the target replenishment space, the input path from the nebulizer to this space is confirmed to be open, and the release path from this space to the user's inhalation pathway remains closed; the input path gating state is closed when any gas path interlock condition is not met, a leak is detected, or a valve feedback anomaly is detected. The effective transfer coefficients input to this space, The aerosol output per unit time of the atomizer is determined based on the atomizer's drive parameters and operational feedback. For vibrating screen atomizers, the drive parameters include drive voltage, drive frequency, and duty cycle; for compressed air atomizers, the drive parameters include air supply flow rate, nozzle inlet pressure, and nozzle pressure difference. The controller determines the baseline output based on a preset calibration relationship and corrects it using changes in drug level, atomization chamber pressure, or aerosol concentration detection results to obtain the aerosol output per unit time.

[0043] The effective transmission coefficient The ratio of the actual aerosol flux entering the dose storage space to the aerosol flux output by the nebulizer during the stable sampling period after the input path of the i-th dose storage space is opened is determined. Specifically, after the input path is opened and a stable waiting time (e.g., 10s) has elapsed, the controller selects a sampling period of duration T, collects the aerosol concentration and input flow rate at the inlet of the dose storage space, and collects or calculates the output of the nebulizer outlet based on the nebulization drive parameters; the ratio of the amount of aerosol entering the dose storage space to the amount of aerosol output by the nebulizer during the sampling period is limited to between 0 and 1, and is used as the effective transmission coefficient of the current input path of the dose storage space.

[0044] Therefore, when there is deposition, backflow, leakage, insufficient valve opening, or increased pressure in the temporary storage space leading to a decrease in entry efficiency in the input path, the effective transmission coefficient decreases with the actual collected data, thereby automatically correcting the supplementary dose calculation and avoiding overestimation of the temporary dose based solely on the theoretical output of the atomizer.

[0045] When the controller determines that the dose added to the dose storage space has met the difference dose requirement, it closes the input path and seals the dose storage space, putting it into a release-ready state. At this time, a metered-dose nebulizer unit is formed in the dose storage space, ready for release triggered by inhalation.

[0046] S2. When the inhalation start phase is detected and the inhalation drive signal reaches the release threshold, the dose storage space of the quantitative nebulized dose unit that has been formed to be released by inhalation is switched to the release state connected to the user's inhalation pathway, so that the quantitative nebulized dose unit enters the inhalation pathway with the inhalation airflow. The respiratory detection component continuously collects at least one of the user's inspiratory flow rate, inspiratory pressure, airway pressure differential, or respiratory acoustic signals, and generates an inspiratory drive signal. ,definition The signal indicates a positive inspiratory direction; when using an airway pressure differential signal, the controller reverses the direction of the pressure differential signal to enhance inspiratory flow. To increase the respiratory phase, the controller uses release and maintenance thresholds to determine the respiratory phase. The release threshold is higher than the maintenance threshold to create threshold hysteresis, preventing frequent opening and closing of the release path due to short-term signal fluctuations.

[0047] When the inhalation drive signal rises from below the sustain threshold to above the release threshold, and the signal trend indicates that the user is in the inhalation enhancement phase, the controller determines that the inhalation initiation phase has been detected. This determination can be achieved through the following gating structure:

[0048] in, This indicates the result of the inspiratory initiation phase gating. Indicates the release threshold. This indicates the maintenance threshold. The inspiratory initiation confirmation time interval is set according to the sampling frequency of the respiratory detection component, for example, by taking the time length corresponding to a number of consecutive sampling points. Indicates the inhalation drive signal The rate of change over time is determined by the difference between the current sample value and the previous sample value or a number of previous sample values. This is a conditional gating function; it takes the value 1 when the condition within the parentheses is true and 0 when the condition within the parentheses is false. Specifically... Used to determine whether the current inspiratory drive signal has reached the release trigger strength. This is used to determine whether the inhalation drive signal is still in an unreleased or weak inhalation state in the short period of time before the current moment, thereby confirming that this determination corresponds to a new inhalation start process, rather than a repeated triggering in the same inhalation process; It is used to determine whether the inspiratory drive signal is in the rising phase, thereby avoiding misjudgment as the start of inspiratory at the end of inspiratory, during the transition to expiration, or during noise disturbance. The release threshold and maintenance threshold The controller adaptively determines the timing based on the user's current breathing state. Specifically, before the start of a nebulized drug delivery, or during a non-release period in the drug delivery process, the controller selects a breathing observation time window and collects the inspiratory drive signal within that time window. .

[0049] The controller first determines the resting baseline value based on the signal during the no-inhalation or weak-inhalation state within the time window, and then determines the inhalation characteristic amplitude based on the inhalation peak or inhalation plateau value during one or more effective inhalations within the time window. The release threshold... The maintenance threshold is set at a higher proportion between the resting baseline value and the inspiratory characteristic amplitude, for example, the signal value corresponding to 35% to 60% of the effective inspiratory amplitude; The value is set at a proportion below the release threshold, for example, 40% to 80% of the amplitude corresponding to the release threshold. The release threshold is used to determine whether the user has formed an inspiratory initiation action sufficient to trigger dose release, while the maintenance threshold is used to determine whether the dose release can still be maintained during the inhalation process. Since the maintenance threshold is lower than the release threshold, the two form a threshold hysteresis range. When the inspiratory drive signal fluctuates briefly, as long as it does not fall below the maintenance threshold, the release path will not be frequently shut off; the controller only terminates the release when the inspiratory drive signal drops significantly below the maintenance threshold, or when the inspiratory termination phase is detected.

[0050] In one specific implementation, the controller can determine the two thresholds in the following way: Inspiratory drive signals are collected over several respiratory cycles prior to drug administration. After removing obvious abnormalities, a resting baseline value is determined. Then, the peak signal from the most recent or several recent effective inspiratory cycles is selected as the inspiratory characteristic value for the current user. A release threshold is then determined from the resting baseline towards the inspiratory characteristic value according to a preset ratio, and a maintenance threshold is determined based on the proportion below the release threshold. Thus, differences in inspiratory strength among different users, and variations in inspiratory capacity of the same user at different times, can be reflected in the release and maintenance thresholds through real-time data collection.

[0051] If the user's breathing is weak, the amplitude of the inhalation characteristic is low, and the release threshold is lowered accordingly, so that the device can still trigger release at the start of effective inhalation; if the user's inhalation is strong, the release threshold is increased accordingly to avoid premature release caused by environmental disturbances, weak airflow or false triggering signals.

[0052] When the controller detects the inhalation start phase and there is a dose storage space where a metered nebulized dose unit has already been formed, it selects one of the dose storage spaces as the current release space. Let the current release space be the j-th dose storage space, and its pre-release dose be... The current unit release dose is:

[0053] Subsequently, the controller opens the release path between the j-th dose storage space and the user's inhalation pathway, allowing the metered nebulized dose unit therein to enter the user's inhalation pathway with the inhalation airflow.

[0054] During the release process, the direct path from the nebulizer to the user's inhalation pathway remains closed, allowing only the current release space to connect with the user's inhalation pathway. Other dose storage spaces remain isolated or in a metering storage state. Therefore, the aerosol entering the user's inhalation pathway originates only from the pre-formed metered nebulization unit, rather than from the instantaneous output of the nebulizer.

[0055] If the controller detects that there is no dose storage space for a pre-formed metered nebulized dose unit at the start of the inhalation phase, it will not open the direct path from the nebulizer to the user's inhalation pathway, but will continue to control the nebulizer to input aerosol into the dose storage space which is in an airway isolation state in order to form a subsequent metered nebulized dose unit.

[0056] S3. Measure the amount of aerosol delivered from the dose storage space into the inhalation pathway in the release state to obtain the actual delivered dose. When the actual delivered dose reaches the release dose of the current unit, the inhalation termination phase is detected, or the inhalation drive signal is lower than the maintenance threshold, the release is terminated and the airway isolation is restored, so that the effective residual dose corresponding to the undelivered residual aerosol is included in the initial dose when the dose storage space forms a metered nebulized dose unit for the next time. like Figure 2 As shown, before the j-th dose storage space is switched to the release state according to S2, the controller first reads the dose status record when the dose storage space forms a quantitative nebulization dose unit in S1.

[0057] The dose status record includes at least the spatial identifier of the dose storage space, the dose before release, the dose already replenished, the effective residual dose, the dose to be released, and the current gas path status.

[0058] Wherein, the pre-release dose of the j-th dose storage space The dose is derived from the quantitative nebulization unit formed in the space of S1 under gas path isolation. If there is an effective residual dose in the dose storage space before its formation, the pre-release dose is composed of the effective residual dose and the dose added during this isolation; if there is no effective residual dose in the dose storage space, the pre-release dose is composed of the dose added during this isolation.

[0059] After the j-th dose storage space is switched to the release state according to S2, the controller does not directly include the total amount of aerosol detected during the release path opening into the actual delivered dose. Instead, it establishes an effective release phase window based on the inhalation start phase, release threshold, maintenance threshold, and gas path interlock status already determined by S2.

[0060] The release phase effective window is used to confirm whether the currently detected aerosol belongs to an effective inhalation delivery process. Specifically, the controller only includes the aerosol flux in the actual delivery dose when the release path between the j-th dose storage space and the user's inhalation path is open, the direct path from the nebulizer to the user's inhalation path remains closed, the inhalation drive signal is not lower than the maintenance threshold, the airflow direction in the release path is towards the user's inhalation path, and the current release has not exceeded the release dose of the current unit.

[0061] The controller records the above-mentioned release phase effective window as The release phase effective window It is a binary gating quantity generated by the controller during the release of the j-th dose buffer space, used to determine whether the aerosol flux at the current sampling time belongs to the effective inspiratory delivery quantity.

[0062] When the release path between the j-th dose storage space and the user's inhalation pathway is open, the direct path from the nebulizer to the user's inhalation pathway is closed, and the inhalation drive signal is activated... Not lower than the maintenance threshold When the airflow direction within the release path is directed towards the user's inhalation pathway, and the current actual delivered dose has not yet reached the current unit's release dose, the controller determines that the release phase effective window is in an effective state. .

[0063] If any of the above conditions are not met, the controller determines that the release phase valid window is invalid. .

[0064] Therefore, the actual delivered dose of the j-th dose storage space during this release process is determined according to the following formula:

[0065] in, This refers to the opening time of the release path in the j-th dose storage space. After the release path opening command is issued, and confirmed by the valve status, gas path interlock status, inhalation maintenance status, and release direction flow rate, this is the effective release start time. If the inhalation drive signal has already fallen below the maintenance threshold before the release valve reaches the effective opening state, or if the gas path interlock status does not meet the requirements, the controller cancels this release and does not include the aerosol quantity detected during this time period in the actual delivered dose. The actual delivered dose up to time t. To release the aerosol concentration within the pathway, The effective inhalation flow rate is directed towards the user's inhalation pathway. To release the effective phase window.

[0066] in The aerosol concentration is directly collected by an aerosol concentration detection unit located downstream of the release valve of the j-th dose storage space and upstream of the user's inhalation pathway inlet. The aerosol concentration detection unit can be a light scattering concentration sensor, a light transmission concentration sensor, a particle counting sensor, or other detection units capable of characterizing aerosol mass concentration or quantity concentration.

[0067] At the moment the release path is opened Then, the controller can first exclude the transient period of valve opening, select a short, stable sampling period after the release path opens, and smooth or average the concentration detection values ​​during this period as the representative concentration value of the release path at the initial stage of release; subsequently, during the release process, the concentration detection values ​​within the release path are collected in real time and used as... Integrate the actual delivered dose.

[0068] If there is a dead space in the valve, residual gas in the path, or short-term uneven mixing when the release path is first opened, the controller does not directly use the single-point concentration value at the moment of opening, but uses the effective concentration value during the stable sampling period after opening, in order to avoid miscounting the transient disturbance of the valve into the actual delivered dose.

[0069] Without setting up a concentration sensor along the release path The concentration is calculated based on the aerosol concentration in the space before the release of the j-th dose storage space, the volume of the release path, the opening degree of the release valve, the inhalation flow rate, and the transmission coefficient of the release path. At this time, the controller first collects the aerosol concentration in the j-th dose storage space in the closed state before release, and then corrects it according to the flow rate and path dilution after the release path is opened. The corrected concentration is taken as the aerosol concentration in the release path.

[0070] The effective inhalation flow rate, determined by direction, includes only the flow component moving from the current release space towards the user's inhalation pathway. The controller determines the airflow direction based on the bidirectional flow sensor readings or the pressure difference across the release path. When the airflow direction points towards the user's inhalation pathway and the inhalation drive signal is not lower than the maintenance threshold, the corresponding flow rate is determined as the effective inhalation flow rate. When the airflow direction is reversed, the flow rate is below the effective detection limit, or the inhalation drive signal is below the maintenance threshold, the effective inhalation flow rate is zero.

[0071] The actual delivered dose is directly related to the inspiratory phase recognition result in S2. Only when the inspiratory drive signal still meets the release maintenance conditions, the airway interlock is correct, and the aerosol actually enters the user's inhalation pathway along the inhalation direction, is the corresponding aerosol volume included in the actual delivered dose. If the release path is briefly open but the user's inhalation is insufficient, inhalation has terminated, airflow backflow occurs, or the nebulizer's direct path is abnormally connected, the aerosol volume for the corresponding time period is not included in the cumulative actual delivered dose.

[0072] When insufficient inhalation or inhalation termination is detected, the controller stops the current release and excludes the aerosol volume for the corresponding time period from the actual delivered dose. If exhalation backflow, leakage, abnormal release path, or nebulizer direct connection risk is further detected, the controller closes the relevant input and release paths and marks the corresponding dose storage space as abnormal or malfunctioning. The aerosol volume for this time period is not included in the actual delivered dose and is not used as a rolling compensation amount. If necessary, an alarm, purging, clearing, or recalibration will be performed.

[0073] When the controller determines that the actual delivered dose has reached the current unit release dose determined by S2, or when the inhalation termination phase is detected, or when the inhalation drive signal drops below the maintenance threshold, the controller closes the release path between the j-th dose storage space and the user's inhalation pathway, restoring the dose storage space to an airway isolation state.

[0074] After the release, the controller adds the actual delivered dose to the cumulative actual delivered dose. The cumulative actual delivered dose is updated only based on the effective inspiratory delivery volume obtained from the actual delivered dose formula, and is not directly calculated based on the nebulizer output, release path opening time, or the dose before release in the dose storage space.

[0075] After restoring gas path isolation in the j-th dose storage space, the controller performs an effectiveness correction on the undelivered residual aerosols in that space. Specifically, the controller reads the pre-release dose of the j-th dose storage space and determines the residual dose based on the actual delivered dose formula. Simultaneously, during the stable sampling period before release and the residual confirmation period after release, at least one of the following is collected in the dose storage space: aerosol concentration, space pressure, residence time, and deposition distribution state.

[0076] The effective residual dose is determined by a combination of the residual dose and the residual release retention rate:

[0077] in, This marks the end of the release process. and These represent the representative aerosol concentration values ​​during the stable sampling period before release and the residual confirmation period after release, respectively. These representative concentration values ​​are determined by averaging the values ​​after continuous data collection from the concentration sensor, removing extreme values. and These represent the spatial pressure values ​​before and after release, respectively. The pressure values ​​are collected by a pressure sensor and determined by averaging after environmental pressure compensation and outlier removal. This is the sedimentation distribution retention coefficient, which is determined based on the concentration distribution at multiple points. The cumulative residence time of aerosols within this dose-limiting space is determined by the entry time and dose percentage of each portion of the dose, and is thus defined as the equivalent residence time. The equivalent deposition time constant is This indicates that the result within the parentheses is limited to between 0 and 1.

[0078] in To characterize the rate at which the effective releasable proportion of aerosols decreases due to retention, deposition, agglomeration, or wall adhesion within the dose storage space, specifically, after the controller forms a quantitative atomized dose unit in the j-th dose storage space, or after the release ends and gas path isolation is restored, a deposition calibration time window is selected. Within this time window, the controller collects at least one of the following data within the dose storage space: aerosol concentration, particle count, light scattering intensity, deposition distribution image, or space pressure. The controller uses aerosol concentration, particle count, or light scattering intensity as a representative quantity of releasability and determines the equivalent deposition time constant based on the rate of decrease of this representative quantity within the deposition calibration time window.

[0079] When aerosol concentration is used as a representative measure of releasability, the controller can select two sampling times within the deposition calibration time window. and ,in Collect the corresponding aerosol concentration and If satisfied This indicates that the aerosol concentration in the temporary storage space effectively decreases, and based on... and Determining the proportion ,Right now If satisfied If the difference between the two is less than the minimum effective attenuation corresponding to the sensor resolution, it indicates that no effective concentration attenuation was detected within the calibration time window. In this case, the dose obtained from the previous calibration cycle is retained in the dose storage space. Unchanged, if satisfied This indicates that the sampling results may be affected by uneven aerosol mixing, sensor fluctuations, local resuspension, pressure disturbances, or sampling errors. In this case, the controller does not update the equivalent deposition time constant based on the data from this time window, and instead selects a new deposition calibration time window for sampling.

[0080] When a certain detection condition is not configured, the corresponding correction term can take a neutral value, so that the effective residual dose can still be corrected based on at least one of the collected residence time, concentration decay, pressure change, or deposition distribution. Therefore, the effective residual dose is not a simple difference between the pre-release dose and the actual delivered dose, but a residual dose after releaseability correction.

[0081] After the correction is completed, the controller writes the effective residual dose into the dose status record of the j-th dose storage space and continues to bind it to the space identifier of that dose storage space. This effective residual dose serves as the initial dose for the next quantitative nebulization dose unit formed in the j-th dose storage space. That is, residual aerosol that has been validated and has not exceeded the preset effective storage time can be used as the initial dose for the next quantitative nebulization dose unit. If exhaled refluxing, condensate ingress, leakage, abnormal pressure, concentration below the lower limit, or residence time exceeding the limit is detected, it is marked as invalid residue and emptied or removed.

[0082] If the current release ends because the actual delivered dose reaches the current unit's release dose, the controller determines that the metered nebulizer unit has completed its release. If the current release ends prematurely due to the inhalation termination phase, the inhalation drive signal falling below the maintenance threshold, or the release phase effective window failing, the controller determines the portion of the current unit's release dose that was not included in the actual delivered dose as an underdelivery, and transfers this underdelivery to the subsequent supplementary dose calculation in S4.

[0083] S4. Based on the target delivery dose, the cumulative actual delivery dose, the initial dose of each dose storage space, and the difference between the current unit release dose and the actual delivery dose, determine the supplementary dose of the subsequent quantitative nebulization dose unit, and make different dose storage spaces alternately complete isolated metering storage and inhalation-triggered release until the cumulative actual delivery dose reaches the target delivery dose.

[0084] After S3 completes the actual delivery dose measurement, cumulative actual delivery dose update and effective residual dose locking, the controller determines the supplementary dose for subsequent quantitative nebulization dose units based on the target delivery dose, cumulative actual delivery dose, initial dose of each dose storage space, and the difference between the current unit release dose and the actual delivery dose.

[0085] The difference between the current unit release dose and the actual delivered dose is used to characterize the underdelivery amount during this release process. When this release ends prematurely, the underdelivery amount is allocated to the dose storage space in the isolation formation state or the next isolation formation state; when this release is completed normally, the underdelivery amount does not participate in subsequent compensation.

[0086] For the m-th dose storage space that enters the isolation metering temporary storage state next, the controller first reads the dose status record of that space to determine whether it has been bound with an effective residual dose, and whether the space has received but not yet released some aerosol during the parallel replenishment process. Subsequently, the controller uses the effective residual dose and the replenished dose as deduction items, and only replenishes the nebulizer for the still insufficient portion.

[0087] The subsequent difference replenishment amount shall be determined according to the following formula:

[0088] in This represents the correction difference dose that still needs to be added to the m-th dose temporary storage space at the current moment. The maximum dose that can be temporarily stored in a single dose storage space. To deliver the target dose, This represents the cumulative actual delivered dose up to the current time. For the preset unit dose, This refers to the underdelivery amount generated by the current release from the j-th dose buffer and allocated to the m-th dose buffer. The effective residual dose that has been locked in the m-th dose temporary storage space. This represents the dose that has already been added to the temporary dose storage space for the m-th dose.

[0089] The controller determines the volume dose defined by effective volume and releasable concentration, the pressure dose defined by upper pressure limit, the safe dose defined by single inhalation safety requirements, and the stable dose defined by retention and deposition characteristics, and takes the smaller of these as the maximum dose that the dose storage space allows to form. The single-inhalation safety requirements can be determined based on at least one of the following: prescription dosing regimen, drug instructions, patient age or weight, interface type, previous inhalation ability, preset treatment level, or doctor-set parameters.

[0090] The preset unit dose This serves as the baseline dose used by the controller to generate a single metered-dose nebulizer unit. The controller calculates the average unit demand based on the target delivery dose and the expected number of releases, and is further limited by the user's capacity for a single inhalation, the maximum dose that each dose storage space can hold, and the prescription or dosing level settings. Therefore, the preset unit dose will not exceed the dose that the user can effectively deliver into the inhalation pathway with a single inhalation, nor will it exceed the dose that any of the dose storage spaces involved in alternating releases can stably hold.

[0091] The The dose is determined by the difference between the current unit release dose and the actual delivered dose. Specifically, when the release path of the j-th dose storage space is prematurely closed due to the inspiratory termination phase or the inspiratory drive signal falling below the maintenance threshold, and the gas path status and dose detection status are valid, the controller will... The positive value is determined as the under-delivery amount generated in this release; when the release path is closed because the release dose of the current unit has been reached, or when there is leakage, blockage, abnormal valve feedback, or abnormal dose detection in the release process, the controller will not use this difference as the under-delivery amount that can be rolled over for compensation.

[0092] For dose storage spaces that can receive compensation, the controller determines the allocation ratio of the under-delivery amount based on the remaining replenishable capacity of each space, the locked effective residual dose, the dose that has been replenished but not yet released, and the current gas path status. If only one dose storage space is in the isolation formation state, the entire under-delivery amount is allocated to that space; if multiple dose storage spaces can receive compensation, the under-delivery amount is allocated according to the proportion of the remaining replenishable capacity of each space. Thus, the under-delivery amount is not simply accumulated to the next unit, but is rolled over among dose storage spaces that still meet the conditions of space capacity, safe inhalation, and isolation formation.

[0093] The formula for subsequent difference replenishment reflects both three restrictions and two deductions.

[0094] The three restrictions are: subsequent quantitative nebulization dose units must not exceed the capacity limit of a single dose storage space; they must not exceed the remaining target delivery dose that has not yet been completed in this dosing process; and only the under-delivery amount formed by the difference in this release will be received based on the preset unit dose, without additional through-pass spraying.

[0095] The two deductions are as follows: If the m-th dose storage space already has an effective residual dose bound to it, then that effective residual dose will be used to deduct the subsequent replenishment requirement; if the m-th dose storage space has already been partially replenished with aerosol during the release of another space, then that replenished dose will be used to deduct the subsequent replenishment requirement. Only the portion that is still insufficient after deduction will be replenished by the nebulizer to the m-th dose storage space.

[0096] When one dose storage space is in the release state, the controller can select another dose storage space in the airway isolation state to perform parallel replenishment. During parallel replenishment, the dose storage space being replenished is always isolated from the user's inhalation pathway, and the aerosol generated by the nebulizer can only enter the dose storage space and cannot directly enter the user's inhalation pathway.

[0097] During parallel replenishment, the controller continuously receives updates on the actual delivered dose in the release space and dynamically adjusts the differential dose in the isolation replenishment space according to the subsequent differential replenishment formula. If the actual delivered dose in the release space continues to increase, the cumulative actual delivered dose increases synchronously, and the remaining replenishment requirement in the isolation replenishment space decreases accordingly. If the release space experiences under-delivery due to premature termination of inhalation, the under-delivery is allocated to the isolation replenishment space or the dose storage space for the next entry into the isolation formation state for rolling compensation.

[0098] When the corrected difference dose in the m-th dose storage space has been replenished, or the dose in that space has reached the corrected target aerosol dose, the controller shuts off the input path from the nebulizer to that space and closes the dose storage space, putting it into a state awaiting inhalation-triggered release. If the cumulative actual delivered dose has reached the target delivered dose, the controller stops the nebulizer output, closes the release path between each dose storage space and the user's inhalation pathway, and ends the current nebulization administration process. After the current nebulization administration process ends, the controller marks the unreleased residual aerosol in each dose storage space as the termination residue of this treatment course and performs emptying, removal, disposal, or invalidation marking; this residue is not carried over to the next administration process.

[0099] When only two dose storage spaces are set, the two dose storage spaces can alternately perform isolated dose storage and inhalation-triggered release: when one space is releasing, the other space is isolated and replenished; after the release is completed, the release space locks the effective residual dose, and the replenishment space enters the waiting-to-release state after being corrected according to the actual delivery results.

[0100] When setting up more than three dose storage spaces, the controller can select the space to participate in the next release or replenishment based on the status records of each dose storage space. When selecting a release space, priority is given to the space where a quantitative nebulized dose unit has been formed and the state to be released is stable; when selecting a replenishment space, priority is given to the space where an effective residual dose has been bound, the required differential replenishment amount is small, and the gas path is in normal condition.

[0101] The above description is only a preferred embodiment of the present invention, but the scope of protection of the present invention is not limited thereto. Any equivalent substitutions or modifications made by those skilled in the art within the scope of the technology disclosed in the present invention, based on the technical solution and inventive concept of the present invention, should be covered within the scope of protection of the present invention.

[0102] Through the above process, S4 forms a closed-loop relationship with S1, S2, and S3: S1 forms a metered-dose nebulizer unit that can be triggered by inhalation; S2 determines the release trigger time and the current unit release dose; S3 obtains the actual delivered dose based on the effective inhalation window and locks the effective residual dose; S4 then adjusts the subsequent supplementary dose based on the actual delivery result, underdelivery, and the initial dose of each storage space. Throughout the process, the output of the nebulizer is always used to replenish the aerosol in the dose storage space that is in an airway-isolated state, and is not used for direct, immediate compensation to the user's inhalation pathway.

[0103] Example 2, as follows Figure 3 The nebulized dose synchronization control device based on respiratory phase recognition shown specifically includes: The device includes a nebulizer, at least two dose storage spaces, a user inhalation pathway, a gas path switching assembly, a breathing detection assembly, a dose detection assembly, and a controller.

[0104] The nebulizer is used to atomize the liquid medication into an aerosol, and its outlet is selectively connected to each dose storage space via a gas path switching component. The at least two dose storage spaces are gas-isolated from each other, and each dose storage space can be in an isolated metering storage state, a pending release state, an inhalation-triggered release state, or a residual lock state under the control of the controller. Each dose storage space is provided with an input end and a release end; the input end is used to receive the aerosol generated by the nebulizer, and the release end is used to connect to the user's inhalation pathway upon inhalation triggering.

[0105] The gas path switching assembly includes an input valve, a release valve, and an isolation valve corresponding to each dose storage space. The controller controls the opening and closing of the input valve, release valve, and isolation valve, ensuring that the aerosol generated by the nebulizer first enters the dose storage space, which is in a gas path isolation state, for temporary metering and storage, instead of directly entering the user's inhalation pathway. When a dose storage space is released, the controller closes the input path of that space, opens only the release path between that space and the user's inhalation pathway, and blocks the direct path between the nebulizer and the user's inhalation pathway.

[0106] The respiratory detection component is located at the user's inhalation pathway, mouthpiece, or mask interface to collect inspiratory flow rate, inspiratory pressure, airway pressure differential, or respiratory acoustic signals, and generate an inspiratory drive signal. When using a mask interface, the controller can further adjust the trigger threshold and release maintenance conditions based on mask leakage, interface pressure waveform, exhaled regurgitation signal, or patient type. When using a mouthpiece interface, appropriate mouthpiece seal or airflow direction confirmation conditions can be used. The controller identifies the inspiratory initiation phase, inspiratory maintenance state, and inspiratory termination phase based on the inspiratory drive signal. When the inspiratory initiation phase is detected and the inspiratory drive signal reaches the release threshold, the controller connects the dose storage space of the pre-formed quantitative nebulized dose unit to the user's inhalation pathway, allowing the quantitative nebulized dose unit to be released with the inspiratory airflow.

[0107] The dose detection component is used to detect at least one of aerosol concentration, particle number, release flow rate, input flow rate, or space pressure to determine the temporary dose, replenishment dose, actual delivered dose, and residual dose within the dose storage space. During release, the controller only includes the corresponding aerosol flux in the actual delivered dose when the release path is open, the inhalation drive signal is not lower than the maintenance threshold, the airflow direction is towards the user's inhalation pathway, and the nebulizer direct path is closed.

[0108] The controller includes an isolation metering and storage module, an inspiratory phase-triggered release module, an actual delivery and residual locking module, and a subsequent replenishment and alternation control module. The isolation metering and storage module controls the nebulizer to input aerosol into the dose storage space, which is in a gas path isolation state, and forms a quantitative nebulization dose unit based on the target delivery dose, preset unit dose, under-delivery amount, and effective residual dose. The inspiratory phase-triggered release module activates the corresponding release path after identifying the inspiratory initiation phase. The actual delivery and residual locking module measures the actual delivery dose and, after release, determines the residual dose based on the difference between the pre-release dose and the actual delivery dose. It then uses residence time, deposition distribution, concentration decay, or changes in space pressure to effectively correct the residual dose, obtaining the effective residual dose, and binds it to the original dose storage space. The subsequent replenishment and alternation control module determines the subsequent replenishment dose based on the target delivery dose, cumulative actual delivery dose, effective residual dose, and under-delivery amount, and controls different dose storage spaces to alternately complete isolation metering and inspiratory triggering release until the cumulative actual delivery dose reaches the target delivery dose.

[0109] Therefore, the device of this embodiment can decouple the nebulization process from the inhalation and release process, and improve the dose synchronization and delivery accuracy of nebulized drug delivery through alternating temporary storage of multiple dose storage spaces, inhalation-triggered release, actual delivery metering, residual dose locking, and under-delivery rolling compensation.

[0110] In one specific implementation, each dose storage space is equipped with an input end, a release end, a pressure detection end, and a residual confirmation end. The input end is connected to the nebulizer outlet via an input valve, and the release end is connected to the user's inhalation path via a release valve. When the input valve is open, the release valve remains closed; when the release valve is open, the input valve remains closed. When abnormal feedback from the input valve or release valve is detected, the pressure in the dose storage space exceeds a preset safety range, the airflow direction in the release path is abnormal, or there is a risk of direct connection between the nebulizer and the user's inhalation path, the controller closes the input and release paths of the corresponding dose storage space and marks the space as an abnormal isolation state.

[0111] In one specific embodiment, the dose detection component includes an input flow detection unit located at the inlet of the dose storage space, a bidirectional flow detection unit located on the release path, an aerosol concentration detection unit located within the dose storage space or on the release path, and a pressure detection unit located within the dose storage space. The controller only includes the detected aerosol flux within the inhalation pathway side as the actual delivered dose when the release valve is open, the input valve is closed, the inhalation drive signal is not lower than the maintenance threshold, the airflow direction in the release path is towards the user's inhalation passage, and no leakage is detected.

[0112] In one specific implementation, after the release is completed, the controller first closes the release valve and keeps the dose storage space isolated. Then, within a preset residual confirmation time, it collects the aerosol concentration, space pressure, and residence time in the dose storage space. If the residence time of the residual aerosol exceeds the preset effective storage time, or the concentration within the residual confirmation time is lower than the lower limit of the release concentration, or if exhaled gas backflow, condensate ingress, abnormal pressure, or leakage is detected, the controller marks the residual aerosol as invalid residue and performs evacuation or removal before the next agglomeration. If the above abnormalities do not exist, the controller obtains the effective residual dose based on the residual dose and effectiveness correction results and continues to bind it to the original dose storage space.

[0113] In one specific implementation, when a dose storage space prematurely terminates its release due to inhalation termination or the inhalation drive signal falling below the maintenance threshold, the controller records the portion of the current unit's released dose that was not included in the actual dose delivered to the inhalation pathway as an underdelivery. This underdelivery is not directly replenished to the user's inhalation pathway via the nebulizer, but is instead allocated to the dose storage space that is in an isolated metering storage state or the next time it enters an isolated metering storage state, and is compensated for when subsequent metered nebulized dose units are formed.

[0114] The preferred embodiments of the present invention disclosed above are merely illustrative of the invention. These preferred embodiments do not exhaustively describe all details, nor do they limit the invention to the specific embodiments described. Clearly, many modifications and variations can be made based on the content of this specification. This specification selects and specifically describes these embodiments to better explain the principles and practical applications of the invention, thereby enabling those skilled in the art to better understand and utilize the invention. The invention is limited only by the claims and their full scope and equivalents.

Claims

1. A nebulized dose synchronization control method based on respiratory phase recognition, characterized in that, include: S1. During a single nebulized drug delivery process, a dose storage space is set up to isolate the nebulization generation from the inhalation and release gas path, so that the aerosol generated by the nebulizer is temporarily stored in at least one dose storage space independent of the user's inhalation path, forming a quantitative nebulized dose unit to be released by inhalation. S2. When the inhalation start phase is detected and the inhalation drive signal reaches the release threshold, the dose storage space of the quantitative nebulized dose unit that has been formed to be released by inhalation is switched to the release state connected to the user's inhalation pathway, so that the quantitative nebulized dose unit enters the inhalation pathway with the inhalation airflow. S3. Measure the amount of aerosol delivered from the dose storage space into the inhalation pathway in the release state to obtain the actual delivered dose. When the actual delivered dose reaches the release dose of the current unit, the inhalation termination phase is detected, or the inhalation drive signal is lower than the maintenance threshold, the release is terminated and the airway isolation is restored, so that the effective residual dose corresponding to the undelivered residual aerosol is included in the initial dose when the dose storage space forms a metered nebulized dose unit for the next time. S4. Based on the target delivery dose, the cumulative actual delivery dose, the initial dose of each dose storage space, and the difference between the current unit release dose and the actual delivery dose, determine the supplementary dose of the subsequent quantitative nebulization dose unit, and make different dose storage spaces alternately complete isolated metering storage and inhalation-triggered release until the cumulative actual delivery dose reaches the target delivery dose.

2. The nebulized dose synchronization control method based on respiratory phase recognition according to claim 1, characterized in that, When forming a quantitative nebulized dose unit to be released by inhalation, the effective residual dose bound to the dose storage space is used as the initial dose, and the target cluster dose is determined according to the target unit dose, the current remaining delivery dose, and the amount of underdelivery to be compensated; the nebulizer is controlled to input aerosol into the dose storage space which is in a gas path isolation state until the dose in the space reaches the target cluster dose, then the input is stopped and the space is closed.

3. The nebulized dose synchronization control method based on respiratory phase recognition according to claim 1, characterized in that, During the transition from any dose storage space to the release state, the direct output of the nebulizer to the user's inhalation pathway is blocked, and the release path between the dose storage space in the release state and the user's inhalation pathway is opened only; when there is no dose storage space with a pre-formed quantitative nebulized dose unit, release is prohibited by directly connecting the nebulizer to the user's inhalation pathway.

4. The nebulized dose synchronization control method based on respiratory phase recognition according to claim 3, characterized in that, During the release path opening, the aerosol subsequently generated by the nebulizer is introduced into another dose storage space in a gas path isolation state, so that the inhalation release process of the current quantitative nebulizer unit and the isolation formation process of the next quantitative nebulizer unit can be carried out in parallel in different dose storage spaces.

5. The nebulized dose synchronization control method based on respiratory phase recognition according to claim 1, characterized in that, A dose status record is established for each dose storage space and bound to its space identifier. The dose status record includes the stored dose, effective residual dose, dose to be released, and current gas path status. After the release of any dose storage space, the effective residual dose that was not delivered continues to be bound to the dose storage space and serves as the initial dose for the next quantitative nebulization dose unit to be formed in that space.

6. The nebulized dose synchronization control method based on respiratory phase recognition according to claim 5, characterized in that, After the release path is closed, the residual dose is determined based on the difference between the pre-release dose value and the actual delivered dose, and the residual dose is effectively corrected based on at least one of the following: residence time of aerosol in the dose storage space, deposition distribution, concentration decay, or change in space pressure, to obtain the effective residual dose.

7. The nebulized dose synchronization control method based on respiratory phase recognition according to claim 1, characterized in that, When the release path closes before the current unit release dose is reached due to the detection of an inspiratory termination phase or an inspiratory drive signal below the maintenance threshold, the difference between the current unit release dose and the actual delivered dose is determined as the underdelivery amount, and the underdelivery amount is allocated to the dose storage space in the isolation formation state or the next time the isolation formation state is entered for rolling compensation.

8. The nebulized dose synchronization control method based on respiratory phase recognition according to claim 1, characterized in that, When determining the supplementary dose for subsequent quantitative nebulization dose units, the supplementary requirement is determined by combining the under-delivery amount, the remaining amount of the target delivery dose, and the effective residual dose locked in each dose storage space; for dose storage spaces with effective residual dose, the supplementary requirement is first deducted by the effective residual dose, and then the nebulizer is controlled to replenish the difference dose.

9. The nebulized dose synchronization control method based on respiratory phase recognition according to claim 8, characterized in that, During the period of release in one dose storage space and replenishment in another dose storage space, the difference in dose in the replenishment space is corrected based on the actual delivery dose updated in real time in the release space. When the corrected difference dose is replenished, the isolation replenishment space reaches the corrected target cluster dose, or the cumulative actual delivered dose reaches the target delivered dose, replenishment is stopped and the isolation replenishment space is closed.

10. A nebulized dose synchronization control device based on respiratory phase recognition, applied to the nebulized dose synchronization control method based on respiratory phase recognition as described in any one of claims 1-9, characterized in that, include: Nebulizer, at least two dose storage spaces, user inhalation pathway, airway switching assembly, respiratory detection assembly, dose detection assembly, and controller; The controller includes: an isolation metering storage module, used to control at least one metering storage space to be isolated from the user's inhalation pathway, and to allow the aerosol generated by the nebulizer to enter the metering storage space for metering storage, forming a quantitative nebulized dose unit to be released upon inhalation. The inspiratory phase-triggered release module is used to identify the inspiratory initiation phase based on the inspiratory drive signal generated by the respiratory detection component, and when the inspiratory drive signal reaches the release threshold, it controls the dose storage space of the pre-formed quantitative nebulized dose unit to connect with the user's inhalation pathway, so that the quantitative nebulized dose unit is released with the inspiratory airflow. The actual delivery and residual locking module is used to measure the actual delivered dose into the user's inhalation pathway according to the dose detection component during the release state, and to restore the airway isolation after the release is completed, and bind the undelivered residual aerosol as the effective residual dose to the original dose temporary storage space after effectiveness correction. The subsequent supplement and alternation control module is used to determine the subsequent supplement dose based on the target delivery dose, the cumulative actual delivery dose, the initial dose of each dose storage space, and the difference between the current unit release dose and the actual delivery dose, and to control different dose storage spaces to alternately complete isolated metering storage and inhalation-triggered release.

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