CN-121971754-A - Atomization delivery system based on respiration gate control and medicine fog concentration feedback

CN121971754ACN 121971754 ACN121971754 ACN 121971754ACN-121971754-A

Abstract

The invention relates to an atomization delivery system based on breath gating and medicine mist concentration feedback, which comprises a breathing machine (101), a breathing machine ventilation pipeline (103) and a medicine atomization delivery device (102), wherein the medicine atomization delivery device (102) comprises a main control module, an atomizer module (201), a medicine storage bin (202), a medicine mist concentration monitoring module and a breathing mask. The master control module generates an atomization driving gating signal according to the ventilation parameters of the breathing machine and the detection result of the concentration of the medicine fog by combining an atomization gating dynamic calibration algorithm to drive an ultrasonic micro-grid atomization sheet (312) to work, wherein the atomization gating dynamic calibration algorithm comprises inhalation phase window identification based on the ventilation parameters and real inhalation phase window identification based on the spectrum, and performs breath transmission delay calculation to obtain a calibrated atomization gating signal. The invention can realize accurate, quantifiable and personalized drug atomization delivery.

Inventors

YU HUI
ZHAO JING
CHEN XIN
ZHAO XIAOBIN
SUN JINGLAI
ZHANG HANYUE
WANG QINGSONG
GAO YIMING
Mu Qiyue

Assignees

天津大学

Dates

Publication Date: 20260505
Application Date: 20260403

Claims (10)

1. An atomization delivery system based on breath gating and medicine mist concentration feedback comprises a breathing machine (101), a breathing machine ventilation pipeline (103) and a medicine mist delivery device (102), wherein the medicine mist delivery device (102) comprises a main control module, an atomizer module (201), a medicine storage bin (202), a medicine mist concentration monitoring module and a breathing mask, the atomizer module (201) is connected with the breathing mask and is used for delivering generated medicine aerosol to an airway of a patient along with the mechanical ventilation of the breathing machine, the system is characterized in that the atomizer module (201) is provided with a spectrum detection cavity, an ultrasonic micro-grid atomizing sheet (312) is arranged between the medicine storage bin (202) and the spectrum detection cavity, the medicine mist concentration monitoring module is used for acquiring a transmission light signal related to medicine mist concentration of the spectrum detection cavity, the main control module is combined with an atomization gating dynamic calibration algorithm according to breathing machine ventilation parameters and medicine mist concentration detection results to generate an atomization driving gating signal to drive the ultrasonic micro-grid atomizing sheet (312) to work, and the atomization gating dynamic calibration method comprises the steps of identifying an inhalation phase window based on the parameters and carrying out breath transmission delay calculation to obtain the atomization driving signal after the atomization gating dynamic calibration is carried out on the medicine mist gating phase, so that the atomization driving signal is calibrated under the phase of the atomizing gating dynamic calibration.
2. The nebulized delivery system based on breath gating and drug mist concentration feedback of claim 1, wherein the nebulized gating dynamic calibration method is: The main control module acquires ventilation parameters, controls the atomizer module to work in a continuous atomization mode, and generates stable aerosol of the medicine fog; the main control module acquires the ventilation parameters through communication with the breathing machine, identifies an inhalation phase window based on the ventilation parameters, determines the initial moment of side inhalation phase of the breathing machine, and completes the reference calibration of the inhalation period of the breathing machine end; the main control module recognizes the real inhalation time according to the transmission light signals related to the medicine fog concentration monitored by the medicine fog concentration monitoring module, and realizes the recognition of a real inhalation phase window based on the spectrum; The main control module calculates respiratory transmission delay according to the time sequence difference between the respiratory phase window identified based on the ventilation parameters and the real respiratory phase window, and obtains the comprehensive delay offset between the ventilator and the atomizer module link; And the main control module dynamically calibrates the follow-up atomization gating signals according to the comprehensive delay offset to obtain calibrated atomization gating signals so as to ensure that atomization output is always in the range of the real gas-phase sucking window and the atomization output is in the gas-phase sucking stage.
3. The atomized delivery system based on breath gating and medicine mist concentration feedback according to claim 2, wherein the main control module further executes an atomized breathing phase near infrared peak identification closed loop verification step in an atomized administration full period, and the specific method comprises the following steps of collecting absorbance signals of a breathing phase interval in real time through the near infrared medicine mist concentration monitoring module, judging that the current gating time sequence is invalid in matching with a real breathing period if the medicine mist near infrared absorption peak is identified in a breathing phase time window, triggering a recalibration process, carrying out real inhalation phase window identification and breath transmission delay calculation again, recalibrating an atomized gating signal until verification confirms that no medicine mist near infrared absorption peak exists in the breathing phase window, and continuing to execute atomized administration.
4. The nebulized delivery system based on breath gating and drug mist concentration feedback of claim 2, further comprising a nebulized dose closed-loop adjustment method comprising the steps of: determining an initial gating duty cycle according to the calibrated atomization gating signal, and obtaining an effective administration cycle number, a single-cycle dosage, a target delivered dosage and a safe dosage adjustment threshold; calculating the single inhalation period drug delivery amount in the current inhalation period based on the respiratory phase identification result; executing error judgment of the single-call period drug delivery quantity, comparing the single-call period drug delivery quantity with the single-period drug quantity, judging whether the deviation is within a set allowable error range or not, and triggering an alarm to avoid the expansion of a dose accumulated error if the deviation is exceeded; calculating the current actual accumulated delivery quantity; Comparing the current actual accumulated delivery quantity with the target delivery dosage, if the current actual accumulated delivery quantity is judged to reach the target delivery dosage, atomizing treatment is completed, otherwise, executing a dynamic regulation link of a flow atomizing delivery gating strategy, namely comparing the current actual accumulated delivery quantity with the safe dosage regulation threshold value by a main control module, and enabling atomization output to be positioned in an inspiration phase stabilization stage when the current accumulated delivery quantity is lower than the safe dosage regulation threshold value, otherwise, dynamically regulating a gating duty ratio of the atomization output positioned in a real inspiration phase window, enabling the smaller the residual dosage, the lower the gating duty ratio, and entering a micro compensation mode to approximate the target delivery dosage, thereby realizing self-adaptive regulation of an atomization dosing strategy.
5. The breath-gated and mist concentration feedback based nebulized delivery system of claim 4 wherein the inspiratory phase stabilization phase is defined at 80% of the real inspiratory phase window center region, the safe dose adjustment threshold being 95%.
6. The aerosol delivery system based on breath gating and drug mist concentration feedback of claim 5, wherein the aerosol output is dynamically adjusted within a range of 20% -80% of the central region of the real inhalation phase window when in the micro compensation mode.
7. The atomization delivery system based on breath gating and medicine mist concentration feedback according to claim 1, wherein the medicine mist concentration monitoring module is a near infrared medicine mist concentration monitoring module (203), a U-shaped structure is adopted, near infrared detectors (314) are arranged on two side arms of the medicine mist concentration monitoring module, the near infrared detectors (314) comprise near infrared light sources and near infrared receivers, the near infrared light sources are used for emitting near infrared light, the near infrared light sources and the near infrared light sources are used for receiving the near infrared light, the near infrared light sources and the near infrared light sources are symmetrically arranged along the radial direction of an atomization runner, and the near infrared medicine mist concentration monitoring module (203) is matched with a limiting chute (311) on an atomizer module (201) to achieve positioning through a limiting convex rail (305) on the near infrared medicine mist concentration monitoring module, and is fixedly connected with the atomizer module (201) through a fastening fixture (308).
8. The aerosol delivery system based on breath gating and drug mist concentration feedback of claim 7, wherein the emission band of the near infrared light source is selected based on the near infrared intrinsic absorption peak of the drug mist.
9. The atomization delivery system based on breath gating and medicine mist concentration feedback of claim 7, wherein the bottom of the medicine storage bin (202) is detachably connected with the atomizer module (201), and the inside of the atomizer module (201) is of a three-way flow passage structure and is respectively communicated with the medicine storage bin (202), a ventilator ventilation pipeline (103) and a breathing mask.
10. The nebulization delivery system based on breath gating and drug mist concentration feedback of claim 7, wherein the breathing mask is a constant temperature breathing mask (204) with an FPC heating film (313) attached to the inner wall, a breathing mask temperature sensor (310) is provided, and the breathing mask temperature sensor (310) collects the temperature in the cavity and feeds back to the main control module to form a closed loop temperature control.

Description

Atomization delivery system based on respiration gate control and medicine fog concentration feedback Technical Field The invention relates to the technical field of respiratory ventilation gating technology and near infrared spectrum detection, in particular to a precise atomization delivery system capable of dynamically calibrating based on respiratory signals and realizing closed-loop regulation and control of atomized medicines by utilizing near infrared relative medicine fog concentration feedback. Background Acute respiratory distress syndrome (Acute Respiratory Distress Syndrome, ARDS) is a type of acute, diffuse inflammatory lung injury disease induced by a variety of causative factors, the pathological features of which are destruction of the alveolar epithelium and capillary endothelial barrier, reduced lung compliance and severe gas exchange disorders, ultimately leading to acute respiratory failure. According to LUNG-SAFE international multi-center prospective queue research data in 2014, [1], the incidence rate of ARDS in ICU group is 10.4%, wherein the proportion of ARDS in patients receiving mechanical ventilation is 23%, mortality of patients with mild, moderate and severe ARDS is 34.9%, 40% and 46.1% respectively according to Berlin standard [2], and life health safety of people is seriously endangered. Atomized administration is used as a local targeted drug delivery mode, can atomize liquid medicine into micron-sized aerosol particles, and can enter respiratory structures such as throat, trachea, bronchus, alveoli and the like through inhalation, so that local high drug exposure is realized, and gastrointestinal absorption and systemic circulation metabolism are avoided. Compared with oral administration or intravenous administration, the atomization treatment can obviously reduce systemic adverse reaction and improve the effective deposition of the medicine in respiratory tract. Therefore, it has become a novel therapeutic approach for asthma and chronic obstructive pulmonary disease. However, there are significant disadvantages to existing nebulized delivery methods. Clinical studies have shown that the efficacy of nebulization therapy depends on the consistency of nebulization start-stop timing with patient inhalation phase and the accuracy of drug delivery. For example, for the rigorous control agents drugs such as budesonide, salbutamol, etc. commonly used in ARDS and severe asthmatics, the actual delivered amount deviates from the prescribed dose by + -5% and may lead to the risk of under-treatment or overdosing. On the other hand, in the long-term nebulization treatment of patients with chronic obstructive pulmonary disease (Chronic Obstructive Pulmonary Disease, COPD), the drug loss rate of the traditional continuous nebulization method can reach 30% -50%, and the deviation of the drug administration dosage often exceeds ±20%, which not only increases the medical cost, but also may cause cross infection due to the residue of the drug solution in the ventilator ventilation line 103. Therefore, realizing "individual dosage regulation, accurate delivery of inhalation phase, and reduction of drug loss" has become a problem to be solved in clinical emergency. Through patent search, the current patents related to medical atomization administration are mainly focused on the aspects of continuous atomization device optimization, real-time monitoring and the like. Tian Chunlai et al disclose a medical nebulization treatment device [3] and Jiang Fangqi et al disclose a method [4] for monitoring the respiration rate of a medical nebulizer module in real time. In order to solve the problem of continuous atomization loss, some technical schemes (such as patent application nos. cn20161177949. X [5] and CN202411801382.8 [6]) propose a technical idea of controlling atomization start and stop based on respiratory signals, but the technical scheme still has limitations, specifically as follows: (1) The lag in respiratory signal acquisition results in the existing gating algorithms not matching the optimal deposition window. The respiratory signal acquisition point is typically located at the main machine end or forward section of the tubing, while the nebulizer module is located at the patient end, with a physical separation between the two, resulting in a significant time lag between the "respiratory signal and nebulization response". The method is difficult to accurately compensate by a fixed delay or manual adjustment mode, and cannot adapt to the breathing state changes of different patients, so that the method cannot accurately match the optimal deposition window in the early inspiration period. (2) The dose of aerosolized drug delivered cannot be monitored in real time and is estimated by physician experience. In the prior art, the actual delivery quantity is roughly estimated by adopting a mode of 'preset dosage multiplied by drug loss coefficient', and the safety requirement of the strict c