Inhalation administration device

Abstract

The invention discloses an inhalation administration device, and relates to the technical field of medical auxiliary instruments. In order to solve the problems that an existing inhalation drug delivery device cannot monitor the real-time breathing state of a patient, drug waste is easily caused, and necessary safety is lacked, the inhalation drug delivery device comprises a mask, an atomizer and a breathing monitoring assembly, the atomizer is connected with the mask through a drug delivery pipeline, and the atomizer is connected with the mask through a drug delivery pipeline. The breathing monitoring assembly is connected with the mask through a breathing pipeline, and a control valve assembly is further arranged between the breathing monitoring assembly and the atomizer and used for blocking connection between the atomizer and the mask when a patient exhales; the respiration monitoring assembly can be adjusted in a self-adaptive mode according to the expiration intensity of the patient, and the expired gas is exhausted at different speeds. The breathing of a patient can be dynamically monitored, medicine waste can be avoided, and the use safety of the device is improved through the arrangement of self-use exhaust.

Description

Technical Field

[0001] This invention relates to the field of medical assistive device technology, and in particular to an inhalation drug delivery device. Background Technology

[0002] In clinical treatment within the Department of Respiratory and Critical Care Medicine, inhaled drug delivery, due to its advantages such as rapid onset of action, minimal systemic side effects, and precise dosage, has become one of the core treatment methods for diseases such as asthma, chronic obstructive pulmonary disease (COPD), and respiratory failure. These patients often present with weakened respiratory function, disordered respiratory rhythms, or decreased respiratory control, and the stability of their respiratory status directly affects the efficacy of inhaled drug delivery.

[0003] Currently used inhalation drug delivery devices (such as pressurized metered-dose inhalers, dry powder inhalers, and nebulizers) mostly operate based on fixed drug release patterns, lacking the ability to dynamically respond to the patient's real-time respiratory status. Drug absorption efficiency is closely related to the synchronicity of the patient's respiratory rhythm. Ideal drug delivery requires precise delivery of the drug to the respiratory tract during the inhalation phase, while avoiding excessive drug carryover during the exhalation phase. Traditional inhalation drug delivery devices lack effective respiratory sensing and airflow control mechanisms. When the patient exhales immediately after inhalation, a large amount of the nebulized drug that has just entered the respiratory tract is directly carried away by the exhaled airflow, failing to deposit sufficiently in target sites such as the alveoli. Clinical data shows that the actual drug utilization rate of some devices is even less than 20%.

[0004] Furthermore, most existing inhaled drug delivery devices operate on a "passive delivery" model, meaning the drug may be continuously released or released at off-peak times regardless of whether the patient is inhaling or exhaling. Drugs released during exhalation not only fail to be absorbed but may also be dispersed due to airflow impact, further reducing the effective drug concentration. For critically ill patients, compliance is low, making it even more difficult to coordinate the dosing rhythm and breathing pattern. Additionally, exhaled air may flow back into the nebulizer, disrupting the pressure balance and drug concentration stability within the nebulizer, affecting the quality and delivery effectiveness of subsequent nebulized medications.

[0005] On the other hand, critically ill patients may experience breathing difficulties or suffocation due to fluctuations in their condition. Traditional inhalation delivery devices, especially nebulizers, cannot quickly adjust the airflow channel in abnormal situations during patient wear and lack convenient manual emergency operation methods, which may cause patients to suffocate and fail to meet clinical safety requirements. Summary of the Invention

[0006] To address the aforementioned problems, this invention aims to provide an inhalation drug delivery device. This device comprises a nebulizer, a face mask, and a respiratory monitoring component. The nebulizer is connected to the face mask via a drug delivery tubing, and the respiratory monitoring component is connected to the face mask via a breathing tubing. A control valve assembly is also provided between the respiratory monitoring component and the nebulizer to block the connection between the nebulizer and the face mask when the patient exhales, preventing the exhaled air from flowing back into the nebulizer. The respiratory monitoring component can adaptively adjust according to the patient's exhalation intensity, allowing the exhaled air to be expelled at different speeds, and can dynamically monitor the exhalation intensity in real time.

[0007] To achieve the above objectives, the technical solution adopted by the present invention is as follows: An inhalation drug delivery device includes a face mask and a nebulizer, the face mask and the nebulizer being connected via a drug delivery tubing; the device further includes: The respiratory monitoring component is connected to the mask via a breathing tube and is used to dynamically monitor the patient's expiratory intensity in real time and to discharge the patient's exhaled gas. A control valve assembly, connecting the respiratory monitoring assembly and the nebulizer, is used to seal the nebulizer and the drug delivery tubing when the patient exhales.

[0008] Furthermore, the respiratory monitoring component includes: The connector has one end connected to the mask via a breathing tube, and the other end is movably connected to a sealing plate for adjusting the exhaust volume. An exhalation sleeve is connected to the control valve assembly and has an air outlet. A label sleeve is connected to the end of the connector that is furthest from the atomizer; An airflow control and monitoring unit extends through the exhalation sleeve and the labeling sleeve.

[0009] Furthermore, the airflow control and monitoring unit includes: The first piston is slidably and sealingly fitted inside the exhalation sleeve to seal and open the air outlet. A control lever is connected to the first piston and passes through the exhalation sleeve and the marking sleeve. One end of the control lever located outside the marking sleeve is provided with a shaped marking segment.

[0010] Furthermore, the airflow control and monitoring unit also includes: A limiting plate is sleeved on the control rod and located inside the marking sleeve; The first reset component connects the control lever and the connecting seat.

[0011] Furthermore, the respiratory monitoring component also includes: Two connecting ears are symmetrically arranged on the connecting seat; Two pressure adjusting rods pass through the two connecting lugs respectively and are connected to the sealing plate; The fourth reset component is connected to the connecting ear and contacts the end of the pressure adjusting rod located outside the connecting ear.

[0012] Furthermore, a pressure-relieving mesh is provided at the center of the sealing plate.

[0013] Furthermore, the atomizer is provided with an air inlet, a compressed gas inlet, a liquid medicine injection inlet, and a medicine outlet.

[0014] Furthermore, the control valve assembly includes: One end of the transmission tube is connected to the exhalation sleeve; The first transmission branch tube is connected to the end of the transmission tube away from the exhalation sleeve, and is connected to the air inlet through the air inlet valve assembly; The second transmission branch pipe is connected to the middle part of the first transmission branch pipe and is connected to the drug outlet through the breathing valve assembly.

[0015] Furthermore, the air inlet valve assembly includes: Air enters the valve body, and its two ends are respectively connected to the first transmission branch pipe and the air inlet; The second piston element is provided with a sliding seal within the air inlet valve body; The second reset component is connected at both ends to the plug body of the second piston component and the air inlet valve body, respectively.

[0016] Furthermore, the air inlet valve assembly includes: The breathing valve assembly is connected at both ends to the second transmission branch pipe and the drug outlet, respectively. The third piston component is slidably sealed within the breather valve assembly; The third reset component is connected at both ends to the plug body of the third piston component and the breather valve assembly, respectively.

[0017] The beneficial effects of this invention are: compared with the prior art, the improvement of this invention lies in that... 1. From an overall structural perspective, the inhalation drug delivery device of the present invention enables nebulized drug delivery through a nebulizer, and the respiratory monitoring component monitors the patient's respiratory status, resulting in higher safety. In addition, the respiratory monitoring component can adaptively adjust the exhaust speed according to the patient's exhalation, which not only ensures sufficient drug deposition in the patient's body but also improves safety. The control valve component connects the nebulizer and the respiratory monitoring component, and can seal the nebulizer and mask when the patient exhales, avoiding waste of drug solution caused by continuous drug delivery through the nebulizer during exhalation.

[0018] 2. The inhalation drug delivery device of the present invention has a respiratory monitoring component connected to the mask. A small portion of the patient's exhaled air is preferentially discharged through the air outlet on the sealing plate, while a large amount of air accumulates in the connecting seat, pushing the first piston to move and then opening the air outlet on the exhalation sleeve. This design allows the patient's initial exhalation to exhibit a slow exhalation characteristic, preventing the exhaled airflow from instantly impacting and carrying away the nebulized drug solution that has just been inhaled into the respiratory tract, thus providing sufficient time for drug absorption. The subsequent opening of the air outlet ensures the smoothness of the exhalation process and does not increase the patient's breathing resistance. During the movement of the first piston, the control rod moves, and the patient's exhalation status can be visually observed and monitored through different marked sections exposed outside the marking sleeve.

[0019] 3. This invention connects the sealing plate and the connecting seat via a pressure adjusting rod. The initial compression of the fourth reset component is adjusted by regulating the connection length between the pressure adjusting rod and the sealing plate, thereby adjusting the force required to separate the sealing plate from the connecting seat. Depending on the patient's breathing intensity, when a large amount of gas accumulates in the connecting seat, the sealing plate can be separated from the connecting seat, reducing the patient's breathing resistance. At the same time, in emergency situations, the sealing plate can be quickly removed from the connecting seat, ensuring the patient's safety without affecting drug administration.

[0020] 4. The control valve assembly in this invention connects the nebulizer and the respiratory monitoring assembly. When the patient's exhaled gas pushes the first piston, the gas or pressurized liquid in the transmission tube pushes the third piston downward through the respiratory valve assembly, closing the drug outlet. The air inlet valve assembly then pushes the second piston downward, closing the air inlet. The patient's exhaled gas can only be discharged through the connector, preventing it from re-entering the nebulizer. At this time, the nebulized medication produced by the compressor is temporarily stored inside the nebulizer, forming a "pre-stored medication" state, preventing continuous drug administration and avoiding drug waste caused by continuous administration during exhalation. When the patient finishes exhaling and enters the inhalation phase, the drug outlet and air inlet open, and the pre-stored nebulized medication is quickly inhaled into the patient's mouth and respiratory tract through the administration tube. External air is introduced into the nebulizer, ensuring smooth breathing and allowing the medication to penetrate deeper into the patient's body through airflow, improving respiratory efficacy. Attached Figure Description

[0021] Figure 1 This is a schematic diagram of the overall structure of the inhalation drug delivery device of the present invention. Figure 1 .

[0022] Figure 2 This is a schematic diagram of the overall structure of the inhalation drug delivery device of the present invention. Figure 2 .

[0023] Figure 3 This is a schematic diagram of the overall structure of the atomizer of the present invention.

[0024] Figure 4 This is a schematic diagram of the overall structure of the respiratory monitoring component of the present invention. Figure 1 .

[0025] Figure 5 This is a schematic diagram of the overall structure of the respiratory monitoring component of the present invention. Figure 2 .

[0026] Figure 6 This is a schematic diagram of the internal structure of the connector and sealing plate in the fitted state of the present invention.

[0027] Figure 7 This is a schematic diagram of the internal structure of the connector and sealing plate in their separated states according to the present invention.

[0028] Figure 8 This is an isometric view of the internal structure of the connector, exhalation sleeve, and marking sleeve of the present invention.

[0029] Figure 9 This is a front view of the internal structure of the connector, exhalation sleeve, and marking sleeve of the present invention.

[0030] Figure 10 This is a schematic diagram showing the connection structure of the control valve assembly, nebulizer, and respiratory monitoring assembly of the present invention.

[0031] Figure 11 This is a schematic diagram of the internal structure of the control valve assembly and atomizer of the present invention.

[0032] Figure 12 This is a schematic diagram of the internal structure of the air inlet valve assembly and the breather valve assembly of the present invention.

[0033] Figure 13 For the present invention Figure 11 Enlarged view of part A in the middle.

[0034] Figure 14 This is a modeling diagram of the inhalation drug delivery device of the present invention.

[0035] Figure 15 This is a modeling diagram of the internal structure of the connector, exhalation sleeve, and label sleeve of the present invention.

[0036] Figure 16 This is a modeling diagram of the internal structure of the control valve assembly of the present invention.

[0037] The components include: 1. Mask; 2. Nebulizer; 201. Air inlet; 202. Compressed gas inlet; 203. Medication inlet; 204. Medication outlet; 3. Respiratory monitoring component; 301. Connecting seat; 3011. Connecting ear; 3012. Pressure regulating rod; 3013. Fourth reset component; 302. Exhalation sleeve; 3021. Air outlet; 3022. First piston; 303. Marking sleeve; 3031. Limiting plate; 3032. First reset component; 304. Sealing plate; 3041. Pressure relief mesh; 305. 3051, First Identification Segment; 3052, Second Identification Segment; 3053, Third Identification Segment; 4, Drug Delivery Line; 5, Breathing Line; 6, Control Valve Assembly; 601, Transmission Pipe; 602, First Transmission Branch Pipe; 603, Second Transmission Branch Pipe; 604, Air Inlet Valve Assembly; 6041, Air Inlet Valve Body; 6042, Second Piston; 6043, Second Reset Member; 605, Breathing Valve Assembly; 6051, Breathing Valve Body; 6052, Third Piston; 6053, Third Reset Member. Detailed Implementation

[0038] To enable those skilled in the art to better understand the technical solutions of the present invention, the technical solutions of the present invention will be further described below in conjunction with the accompanying drawings and embodiments.

[0039] See attached document Figure 1-16 The inhalation drug delivery device shown is mainly used for nebulized drug delivery to patients in the Department of Respiratory and Critical Care Medicine. It includes a mask 1, a nebulizer 2, and a respiratory monitoring component 3. The nebulizer 2 is connected to the mask 1 through a drug delivery tube 4, and the drug delivery tube 4 passes through the mask 1. One end of the drug delivery tube 4 inside the mask 1 can be set as a bottle mouth structure to facilitate the patient to bite it into their mouth for nebulized drug delivery.

[0040] The respiratory monitoring component 3 is connected to the mask 1 via a breathing tube 5, and the breathing tube 5 is connected to both the mask 1 and the respiratory monitoring component 3. Furthermore, the respiratory monitoring component 3 is also connected to the nebulizer 2 via a control valve assembly 6. The control valve assembly 6 is used to seal the nebulizer 2 and the drug delivery tube 4 when the patient exhales, preventing drug waste caused by the nebulizer 2 administering medication while the patient is exhaling; simultaneously, when the patient inhales, the control valve assembly 6 opens the nebulizer 2 and the drug delivery tube 4, without affecting the drug delivery process, thereby improving the drug delivery effect.

[0041] In some embodiments, the mask 1 uses existing atomizing mask materials, including polyvinyl chloride or silicone rubber, and the overall structure of the mask 1 is the same as that of existing atomizing masks. It includes elastic straps (not shown in the figure) for securing the mask 1 to the patient's face. Two connection holes are provided on the mask 1 for connecting the drug delivery tubing 4 and the breathing tubing 5, respectively. Both the drug delivery tubing 4 and the breathing tubing 5 are made of medical-grade PVC, which has advantages such as chemical corrosion resistance, wear resistance, and low cost.

[0042] In some embodiments, the nebulizer 2 is provided with an air inlet 201, a compressed gas inlet 202, a drug injection inlet 203, and a drug outlet 204. The drug outlet 204 is connected to the drug delivery tubing 4 via a plug-in connection. The drug delivery tubing 4 is made of soft PVC material and has a certain degree of elasticity, allowing it to be plugged into the drug outlet 204. The drug injection inlet 203 is used to inject nebulized medication, and a cap is also provided at the drug injection inlet 203 to seal it. The air inlet 201 is connected to the external environment and is used for the entry and exit of air from the nebulizer 2. The compressed gas inlet 202 is connected to a compressor used with the nebulizer 2, thereby atomizing the medication in the nebulizer 2 and discharging it through the drug outlet 204. The compressed gas inlet 202 is also provided with a nebulization control valve 2021 for adjusting the atomization speed of the medication in the nebulizer 2. It should be noted that the atomizer 2 and the matching compressor in this invention can adopt existing structures, such as Yuwell 403M, 403T and other models.

[0043] Preferably, the nebulizer, air inlet 201, compressed gas inlet 202, liquid medicine injection port 203, and medicine outlet 204 are all made of medical-grade rigid PVC material, which can be integrally molded or bonded and fixed, has a certain degree of rigidity, and is convenient to connect with other structures.

[0044] In some embodiments, the respiratory monitoring component 3 includes a connecting seat 301, an exhalation sleeve 302, and an identification sleeve 303. The connecting seat 301 has a hollow structure inside. One end is connected to the mask 1 through a breathing tube 5, and the other end is movably connected to a sealing plate 304. The center of the sealing plate 304 is hollow, and a pressure-reducing mesh 3041 is installed at the hollow center of the sealing plate 304. The pressure-reducing mesh 3041 has a mesh structure. When the sealing plate 304 is fixedly attached to the connecting seat 301, the gas exhaled by the patient can be slowly discharged through the pressure-reducing mesh 3041. At this time, a large amount of gas will accumulate in the connecting seat 301.

[0045] The exhalation sleeve 302 is connected to the end of the connecting seat 301 near the nebulizer 2, and the exhalation sleeve 302 is connected to the nebulizer 2 through the control valve assembly 6. The inner diameter of the exhalation sleeve 302 near the connecting seat 301 is smaller than the inner diameter of the exhalation sleeve 302 near the control valve assembly 6. The exhalation sleeve 302 has an air outlet 3021, which is located in the large inner diameter section. A first piston 3022 is slidably sealed in the large inner diameter section of the exhalation sleeve 302. When the first piston 3022 slides to a position corresponding to the air outlet 3021, the first piston 3022 seals the air outlet 3021. When the first piston 3022 slides to a position away from the air outlet 3021, the air outlet 3021 opens, and the patient's exhaled air can be discharged through the air outlet 3021. Along the gas flow path, the inner diameter of the exhalation sleeve 302 gradually increases, facilitating gas accumulation in the smaller inner diameter section before moving the first piston 3022. This design allows for a slow exhalation phase, preventing the exhaled airflow from instantly impacting and carrying away the newly inhaled nebulized medication, thus providing sufficient time for absorption. The subsequent opening of the outlet 3021 ensures a smooth exhalation process without increasing respiratory resistance.

[0046] The label sleeve 303 is connected to the end of the connecting seat 301 away from the nebulizer 2, but not in a continuous manner; the exhalation sleeve 302, the label sleeve 303, and the connecting seat 301 are integrally formed into a cross-shaped structure. A control rod 305 is bonded to the side of the first piston 3022 near the connecting seat 301. The diameter of the control rod 305 is smaller than the small inner diameter of the exhalation sleeve 302, and the control rod 305 passes through the radial direction of the connecting seat 301 and the axial direction of the label sleeve 303 in sequence. The control rod 305 is slidably and sealingly connected to the side wall of the label sleeve 303 of the connecting seat 301, and finally passes through the end of the label sleeve 303. A limiting plate 3031 is integrally provided on the control rod 305. The limiting plate 3031 is located inside the marking sleeve 303, and a first reset member 3032 is provided between the limiting plate 3031 and the outer wall of the connecting seat 301. The first reset member 3032 is preferably a spring, and the first reset member 3032 is sleeved on the outside of the control rod 305. The end of the control rod 305 located outside the marking sleeve 303 is divided into a first marking segment 3051, a second marking segment 3052, and a third marking segment 3053 by different colors. When the patient exhales, a small portion of the exhaled gas is discharged through the pressure-relieving mesh 3041 on the sealing plate 304, while most of it accumulates in the small inner diameter section of the connecting seat 301 and the exhalation sleeve 302. Then, the first piston 3022 is pushed to move closer to the control valve assembly 6 until it is deviated from the position of the air outlet 3021. At this point, the air outlet 3021 opens, and gas can be discharged through the air outlet 3021. During the movement of the first piston 3022, the control rod 305 moves towards the end closer to the connecting seat 301, compressing the first reset member 3032. Simultaneously, the first marking segment 3051, or the first marking segment 3051 and the second marking segment 3052, moves into the marking sleeve 303. The marking segment exposed outside the marking sleeve 303 allows for direct observation of the patient's exhalation. The first piston 3022 and the control rod 305 form an integrated airflow control and monitoring unit, which can dynamically adjust the exhaled gas output of the patient, and the linkage control valve assembly 6 can seal the nebulizer 2 and the drug delivery tubing 4 during the patient's exhalation, while also monitoring the exhalation intensity.

[0047] In some embodiments, to facilitate the assembly and disassembly of the sealing plate 304, two connecting ears 3011 are symmetrically provided on both sides of the end of the connecting seat 301 near the sealing plate 304. The end of the connecting ear 3011 away from the sealing plate 304 is an open structure, and the end near the sealing plate 304 is a closed structure. A pressure adjusting rod 3012 is provided inside the connecting ear 3011. The pressure adjusting rod 3012 slides through the connecting ear 3011, and the end of the pressure adjusting rod 3012 near the sealing plate 304 is a threaded structure and is threadedly connected to the sealing plate 304. The end of the pressure adjusting rod 3012 away from the sealing plate 304 is a round rod structure. A knob is provided at the end of the round rod outside the connecting ear 3011, and a fourth reset member 3013 is sleeved on the round rod structure. One end of the fourth reset member 3013 is connected to the closed end of the connecting ear 3011, and the other end is in contact with but not connected to the knob at the end of the pressure adjusting rod 3012. When the patient exhales, a small portion of the gas is discharged through the pressure-reducing mesh 3041 on the sealing plate 304, while the majority of the remaining gas accumulates within the connecting seat 301. This gas then pushes the first piston 3022 towards the control valve assembly 6 until it moves away from the air outlet 3021, at which point the air outlet 3021 opens, allowing gas to escape. Before the air outlet 3021 opens, if the patient exhales a large volume of gas, it will first push the sealing plate 304 slightly away from the connecting seat 301, creating a gap between the sealing plate 304 and the end of the connecting seat 301. This facilitates the discharge of some gas from the connecting seat 301, preventing the patient from suffocating. As the patient's exhaled gas pushes the sealing plate 304 away from the connecting seat 301, it pulls the fourth reset member 3013 to extend. When the patient inhales, the fourth reset member 3013 resets, causing the sealing plate 304 to seal tightly against the connecting seat 301. By adjusting the length of the threaded connection between the pressure regulating rod 3012 and the sealing plate 304, different compressive forces can be pre-applied to the fourth reset member 3013. On the other hand, in the event of a sudden patient emergency, the sealing plate 304 can be quickly separated from the end of the connecting seat 301 by rotating the pressure regulating rod 3012, allowing the patient's exhaled air to be quickly discharged from the end of the connecting seat 301.

[0048] It should be noted that the volume of a normal adult's exhalation is approximately 500-600 mL. The elastic modulus of the fourth reset member 3013 is approximately 0.01 N / mm, which ensures that the sealing plate 304 will not separate from the end of the connecting seat 301 under normal circumstances. When the internal pressure of the connecting seat 301 reaches its peak, the sealing plate 304 separates from the connecting seat 301, thus playing a role in assisting pressure relief.

[0049] In some embodiments, the control valve assembly 6 includes a transmission tube 601, which is also a flexible tube. One end of the transmission tube 601 is connected to the exhalation sleeve 302, and the other end is connected to a first transmission branch tube 602. A second transmission branch tube 603 is connected to the middle of the transmission tube 601. The first transmission branch tube 602 is connected to the air inlet 201 on the nebulizer 2. An air inlet valve assembly 604 for connecting the first transmission branch tube 602 is connected to the air inlet 201. The second transmission branch tube 603 is connected to the drug outlet 204 on the nebulizer 2. A breathing valve assembly 605 for connecting the second transmission branch tube 603 is connected to the drug outlet 204.

[0050] The air inlet valve assembly 604 includes an air inlet valve body 6041. Both ends of the air inlet valve body 6041 are connected to the first transmission branch pipe 602 and the air inlet 201, respectively. A second piston 6042 is slidably and sealed inside the air inlet valve body 6041. A second reset member 6043 is sleeved on the rod of the second piston 6042. Both ends of the second reset member 6043 are connected to the plug of the second piston 6042 and the air inlet valve body 6041, respectively.

[0051] The breathing valve assembly 605 includes a breathing valve body 6051. Both ends of the breathing valve body 6051 are connected to the second transmission branch pipe 603 and the drug outlet 204, respectively. A third piston 6052 is slidably and sealed inside the breathing valve body 6051. A third reset member 6053 is sleeved on the rod of the third piston 6052. Both ends of the third reset member 6053 are connected to the plug of the third piston 6052 and the breathing valve body 6051, respectively. Both the second reset member 6043 and the third reset member 6053 are springs with an elastic coefficient of approximately 0.005 N / mm.

[0052] When the patient exhales, the first piston 3022 moves towards the transmission tube 601, squeezing the gas inside the transmission tube 601 (pressurized liquid can also be installed inside the transmission tube 601). This pressure triggers the air inlet valve assembly 604 and the breathing valve assembly 605 to operate: the gas or pressurized liquid in the transmission tube 601 first passes through the breathing valve assembly 605 to push the third piston 6052 downward, closing the drug outlet 204. Then, the air inlet valve assembly 604 pushes the second piston 6042 downward, closing the air inlet 201. The patient's exhaled gas can only be discharged through the connecting seat 301, preventing the patient's exhaled gas from entering the nebulizer in reverse. At this time, the nebulized medication produced by the nebulizer 2 under the action of the compressor is temporarily stored inside the nebulizer 2, forming a "pre-stored medication" state. When the patient finishes exhaling and begins inhalation, the third reset member 6053 pushes the third piston member 6052 upward, opening the drug outlet 204. The pre-stored nebulized medication is then quickly inhaled into the patient's mouth and respiratory tract through the drug delivery tube 4. The second reset member 6043 pushes the second piston member 6042 upward, opening the air inlet 201. Outside air is then introduced into the nebulizer 2, ensuring smooth breathing and allowing the medication to penetrate deeper into the patient's body through airflow, thus improving respiratory efficacy.

[0053] The working principle of the inhalation drug delivery device in this invention is as follows: When using the inhalation drug delivery device of this invention, the patient wears the mask 1 on their face, holds the end of the drug delivery tube 4 in their mouth, and injects the nebulized drug into the nebulizer 2 through the drug injection port 203. The compressor of the nebulizer 2 is then activated, and the drug in the nebulizer 2 is atomized and enters the patient's respiratory tract through the drug outlet 204 and the drug delivery tube 4. Subsequently, during the patient's exhalation, a small portion of the exhaled gas is discharged through the pressure-reducing mesh 3041 on the sealing plate 304, while most of it accumulates in the small inner diameter section of the connecting seat 301 and the exhalation sleeve 302. When the first piston 3022 is pushed towards the control valve assembly 6 and moves away from the position of the air outlet 3021, the air outlet 3021 opens, and the gas can be discharged through the air outlet 3021. Before the air outlet 3021 is opened, if the patient exhales a large amount of air, the sealing plate 304 will be pushed slightly away from the connecting seat 301, so that a gap is formed between the sealing plate 304 and the end of the connecting seat 301, so that some of the gas inside the connecting seat 301 can be discharged, and the patient will not experience suffocation.

[0054] During the movement of the first piston 3022, the control rod 305 will move towards the end closer to the connecting seat 301, squeezing the first reset member 3032. At the same time, the first marking segment 3051 or the first marking segment 3051 and the second marking segment 3052 will move into the marking sleeve 303. The patient's exhalation status can be directly observed through the marking segment exposed outside the marking sleeve 303.

[0055] At the same time, the first piston 3022 moves towards the transmission tube 601, squeezing the gas or pressurized liquid in the transmission tube 601 and pushing the third piston 6052 downward through the breathing valve assembly 605, thus closing the drug outlet 204. The second piston 6042 is pushed downward through the air inlet valve assembly 604, thus closing the air inlet 201. The patient's exhaled gas can only be discharged through the connecting seat 301, preventing the patient's exhaled gas from entering the nebulizer in reverse. At this time, the nebulized drug produced by the nebulizer 2 under the action of the compressor is temporarily stored inside the nebulizer 2, forming a "drug pre-storage" state.

[0056] When the patient finishes exhaling and begins inhalation, the third reset member 6053 resets, pushing the third piston member 6052 upward to open the drug outlet 204. The nebulized medication pre-stored in the nebulizer 2 is then quickly inhaled into the patient's mouth and respiratory tract through the drug delivery tube 4. The second reset member 6043 pushes the second piston member 6042 upward, opening the air inlet 201 and allowing outside air to enter the nebulizer 2. This cycle continues until the patient receives nebulized medication.

[0057] Application examples: Mr. Cheng, male, 54 years old, had a history of emphysema for many years, experiencing coughing and shortness of breath for several days. He sought medical attention at the Department of Respiratory and Critical Care Medicine outpatient clinic and was diagnosed with pneumonia by chest X-ray. He was hospitalized and received daily nebulizer treatment during his hospitalization. The nebulizer drug delivery device of this invention is used for nebulized drug delivery, specifically including the following steps: Step 1: Place the mask on the patient's face; Step 2: Add the nebulized medication into the nebulizer 2, turn on the compressor of the nebulizer 2, and the nebulized medication is inhaled into the patient's body through the delivery tubing 4; Step 3: When the patient exhales, the exhaled air enters the connecting seat 301 through the breathing tube 5. A small portion of the air is discharged through the pressure relief mesh 3041, which at the same time pushes the sealing plate 304 to separate from the connecting seat 301 to form a gap for discharge. Most of the air gathers in the connecting seat 301, which pushes the first piston 3022 to move, and the air outlet 3021 opens to discharge the exhaled air. When the first piston 3022 moves, the drug outlet 204 is closed by the breathing valve assembly 605, and the air inlet 201 is closed by the air inlet valve assembly 604, pausing nebulized drug delivery. After the exhalation ends and the inhalation phase at the pile position is completed, the drug outlet 204 and the air inlet 201 are opened, and normal drug delivery is resumed. This cycle is repeated until nebulized drug delivery is completed.

[0058] The foregoing has shown and described the basic principles, main features, and advantages of the present invention. Those skilled in the art should understand that the present invention is not limited to the above embodiments. The embodiments and descriptions in the specification are merely illustrative of the principles of the invention. Various changes and modifications can be made to the invention without departing from its spirit and scope, and all such changes and modifications fall within the scope of the present invention as claimed. The scope of protection of this invention is defined by the appended claims and their equivalents.

Claims

1. An inhalation drug delivery device, comprising a mask (1) and a nebulizer (2), wherein the mask (1) and the nebulizer (2) are connected via a drug delivery conduit (4); characterized in that, The device further includes: The respiratory monitoring component (3) is connected to the mask (1) via a breathing tube (5) and is used to dynamically monitor the patient's exhalation intensity in real time and to discharge the patient's exhaled gas. The control valve assembly (6) connects the respiratory monitoring assembly (3) and the nebulizer (2) and is used to seal the nebulizer (2) and the drug delivery line (4) when the patient exhales.

2. The inhalation drug delivery device according to claim 1, characterized in that, The respiratory monitoring component (3) includes: The connecting seat (301) is connected to the mask (1) at one end via a breathing tube (5), and the other end is movably connected to a sealing plate (304) for adjusting the exhaust volume. The exhalation sleeve (302) is connected to the control valve assembly (6) and has an air outlet (3021). The marking sleeve (303) is connected to the end of the connector (301) away from the atomizer (2); An airflow control and monitoring unit extends through the exhalation sleeve (302) and the marking sleeve (303).

3. An inhalation drug delivery device according to claim 2, characterized in that, The airflow control and monitoring unit includes: The first piston (3022) is slidably and sealingly fitted inside the exhalation sleeve (302) for sealing and opening the air outlet (3021). The control lever (305) is connected to the first piston (3022) and passes through the exhalation sleeve (302) and the marking sleeve (303). One end of the marking sleeve (303) is provided with a wavy marking segment.

4. An inhalation drug delivery device according to claim 3, characterized in that: The airflow control and monitoring unit also includes: The limiting plate (3031) is sleeved on the control rod (305) and located inside the marking sleeve (303); The first reset component (3032) connects the control lever (305) and the connecting seat (301).

5. An inhalation drug delivery device according to claim 2, characterized in that, The respiratory monitoring component (3) also includes: Two connecting ears (3011) are symmetrically arranged on the connecting seat (301); Two pressure adjusting rods (3012) respectively pass through the two connecting ears (3011) and are connected to the sealing plate (304); The fourth reset member (3013) is connected to the connecting ear (3011) and contacts the end of the pressure adjusting rod (3012) located outside the connecting ear (3011).

6. An inhalation drug delivery device according to claim 5, characterized in that: The sealing plate (304) has a pressure-reducing mesh (3041) at its center.

7. An inhalation drug delivery device according to claim 2, characterized in that, The atomizer (2) is provided with an air inlet (201), a compressed gas inlet (202), a liquid medicine inlet (203), and a medicine outlet (204).

8. An inhalation drug delivery device according to claim 7, characterized in that, The control valve assembly includes: One end of the transmission tube (601) is connected to the exhalation sleeve (302); The first transmission branch pipe (602) is connected to the end of the transmission pipe (601) away from the exhalation sleeve (302), and is connected to the air inlet (201) through the air inlet valve assembly (604); The second transmission branch pipe (603) is connected to the middle part of the first transmission branch pipe (602) and is connected to the drug outlet (204) through the breathing valve assembly (605).

9. An inhalation drug delivery device according to claim 8, characterized in that, The air inlet valve assembly (604) includes: Air enters the valve body (6041), and its two ends are connected to the first transmission branch pipe (602) and the air inlet (201) respectively; The second piston (6042) is slidably sealed within the air inlet valve body (6041); The second reset member (6043) is connected at both ends to the plug of the second piston member (6042) and the air inlet valve body (6041), respectively.

10. An inhalation drug delivery device according to claim 8, characterized in that, The air inlet valve assembly (604) includes: The breathing valve assembly (605) is connected at both ends to the second transmission branch pipe (603) and the drug outlet (204), respectively; The third piston (6052) is slidably sealed within the breather valve assembly (605); The third reset member (6053) is connected at both ends to the plug body of the third piston member (6052) and the breathing valve assembly (605), respectively.

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