An atomizing module, an atomizer, and an atomizing method thereof

Abstract

This invention provides an atomization module for an atomizer, comprising a pressure-resistant solution chamber, a pressure assembly, a heating assembly, and a sealing nozzle. The pressure assembly is connected to the pressure-resistant solution chamber and can increase the pressure inside the chamber. The sealing nozzle is connected to an outlet on the pressure-resistant solution chamber and includes a transition section and a spray plate. The spray plate has an internally closed blind hole. The transition section, the blind hole, and the outlet are interconnected. The blind hole opens from the inside out after exceeding the pressure limit, and the liquid to be atomized is sprayed out from the blind hole. The inner diameters of the pressure-resistant solution chamber, the transition section, and the blind hole decrease sequentially. The heating assembly can heat the pressure-resistant solution chamber. The atomization module of this invention has a faster atomization rate, a larger capacity range for atomized solution per spray, and no special requirements on the device posture during atomization. It can deliver both micro-dose and large-dose drugs as needed, making it more widely applicable.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to an atomizing module, an atomizer, and an atomizing method thereof. Background Technology

[0002] Nebulizers are used to convert inhaled liquid medications into a mist of water that can be inhaled by the patient, allowing for direct drug delivery to the lungs. The nebulizer's own nebulization performance and the user's technique affect its drug delivery effectiveness. Jet nebulizers are the most common nebulization devices in Chinese hospitals, offering advantages such as ease of use, wide applicability to a wide range of medications, high nebulization dose, and the ability to nebulize multiple medications simultaneously. However, they also have disadvantages such as long nebulization time, low drug utilization, significant fluctuations in nebulization effectiveness, dependence on an air or power source, and the need to keep the nebulizer cup vertical during use. Therefore, in recent years, many new nebulization devices have undergone extensive optimization efforts in terms of nebulization rate, drug utilization, and portability.

[0003] The patent "Atomising Nozzle and Filter and Spray Generation Device" (US005472143) discloses an atomizing device and mechanism. It involves compressing a drug solution through a micro-nozzle to form two micro-liquid columns with a specific intersection angle. The collision of these micro-liquid columns in the air converts the drug solution into a fine water mist for inhalation. Compared to traditional aerosols, the output water mist has a slower spray speed, resulting in less drug residue in the mouth and throat. It also requires less hand-mouth coordination from the patient and can significantly improve drug deposition in the lungs. The atomization effect of this device is determined by the diameter and collision angle of the micro-liquid columns, demanding extremely high precision and morphology of the microchannels within the nozzle. Therefore, the manufacturing process is complex and costly. Furthermore, this device can only atomize 10-15 μL of drug solution per spray, making it suitable only for drugs requiring small doses.

[0004] The patent "Aerosol and a Method and Apparatus for Generating an Aerosol" (US5743251) discloses a nebulizer and nebulization mechanism. A drug solution flows through a heated capillary tube, where it is completely vaporized. The pressure increase caused by the volume change after the drug solution converts to a gaseous state accelerates the ejection of the vaporized gas. After ejection, the vapor is pre-cooled and rapidly condenses to form a fine water mist for inhalation. Compared with existing nebulization mechanisms, this mechanism has advantages such as an extremely high proportion of fine particles in the output water mist, nebulization output not depending on patient operation, the ability to nebulize large drug doses, and no reliance on propellants or compressed air. However, the water mist output by this nebulizer mechanism mainly consists of droplets smaller than 1 μm. Current inhalation theory generally considers 2-5 μm to be the ideal inhaled drug delivery particle size. Particles smaller than 2 μm may be exhaled with the patient, potentially affecting the drug delivery effect. Furthermore, the patent "Effective Delivery of Nanoparticles and Micrometer-sized Pharmaceutical Aerosols to the Lung Through Enhanced Condensational Growth" (US 8479728) discloses a novel nebulizer inhalation device. The drug solution is evaporated through a heated capillary tube, spraying out a drug-containing aerosol, which is then mixed with a separate steam stream before being inhaled by the patient. The steam mist provides a higher humidity airflow, allowing particles <1μm in the drug-containing aerosol to condense and grow to over 2μm during inhalation, increasing the drug's deposition rate in the lungs. However, this structure is more complex, and the added steam humidification pathway requires more space, making it more suitable for inpatients in wards. Additionally, the nebulization time is slower, and the need for continuous inhalation of high-humidity air may place an additional burden of sputum on respiratory patients.

[0005] As can be seen, although existing nebulizers have improved drug delivery efficiency while achieving 2-5 micron nebulization effects, they still suffer from drawbacks such as complex structure, high cost, and inconvenience in use. Summary of the Invention

[0006] To address the aforementioned issues, this invention provides an atomization module and atomizer based on a novel atomization mechanism. This module features a fast atomization rate, an easy-to-implement structure, and the ability to atomize large doses of drugs, overcoming the shortcomings of existing atomizers, such as long atomization times, complex atomization structures, high costs, and the ability to atomize only small doses of drugs.

[0007] To achieve the above-mentioned objectives, a first aspect of the present invention provides an atomizing module for an atomizer, comprising a pressure-resistant solution chamber, a pressure assembly, a heating assembly, and a sealing nozzle;

[0008] The pressure component is connected to the pressure-resistant solution chamber, and the pressure component can increase the pressure inside the pressure-resistant solution chamber.

[0009] The sealing nozzle is connected to the outlet on the pressure-resistant solution chamber. The sealing nozzle includes a transition section and a spray blade. The spray blade is provided with a blind hole that is closed to the inside. The transition section, the blind hole and the outlet are connected. After the pressure exceeds the bearing capacity, the blind hole opens from the inside to the outside, and the liquid to be atomized is sprayed out from the blind hole. The inner diameter of the pressure-resistant solution chamber, the transition section and the blind hole decreases in sequence.

[0010] The heating component can heat the pressure-resistant solution chamber.

[0011] Preferably, the inner diameter of the pressure-resistant solution chamber is 2-3 times the inner diameter of the transition section.

[0012] Preferably, the inner diameter of the blind hole is 0.03-0.3 mm, and the inner diameter of the transition section is more than 1.5 times the inner diameter of the blind hole.

[0013] Preferably, the thickness of the blind hole is 0.005-0.02 mm.

[0014] Preferably, a fastener is also provided outside the sealing nozzle, which secures the sealing nozzle to one end of the pressure-resistant solution chamber opening, and the fastener is provided with an opening that covers the blind hole.

[0015] Preferably, the transition section is located entirely or partially inside the liquid outlet.

[0016] Preferably, the heating assembly includes a heat source module, a heat transfer module, and a temperature control module; the heat source transfers heat to the pressure-resistant solution chamber through the heat transfer module, and the temperature control module is used to control the temperature of the pressure-resistant solution chamber and / or the heat transfer module.

[0017] Preferably, the heat transfer module completely or partially covers the pressure-resistant solution chamber, or completely or partially covers the pressure-resistant solution chamber and the inner side of the sealing nozzle.

[0018] Preferably, the heat source module is wholly or partially covered by the heat transfer module.

[0019] Preferably, the sealing nozzle includes a plurality of blind holes, which are arranged within the range of the inner diameter of the corresponding transition section.

[0020] A second aspect of the present invention provides an atomizer, comprising the atomization module, drug storage module, control module, metering liquid delivery module and power module described in the above technical solution, wherein the control module is connected to the atomization module, the metering liquid delivery module and the power module respectively to control the atomization of the atomizer.

[0021] Preferably, the atomizer further includes an airflow sensor capable of sensing the inhaled airflow.

[0022] Preferably, the metering module and the pressure component in the atomization module are integrated into one structure.

[0023] A third aspect of the present invention provides an atomization method, implemented using the atomization module or atomizer described in the foregoing technical solutions, comprising the following steps:

[0024] S1. After the atomized liquid enters the pressure-resistant solution chamber, the pressure-resistant solution chamber is pressurized and heated so that the temperature of the atomized liquid in the pressure-resistant solution chamber exceeds its boiling point at standard atmospheric pressure by more than 10°C.

[0025] S2. Continue to pressurize the pressure-resistant solution chamber until the pressure of the liquid to be atomized in the pressure-resistant solution chamber is higher than the preset pressure of the blind hole in the sealed nozzle. At this point, the blind hole deforms and ruptures, and the liquid to be atomized is ejected from the deformed blind hole and atomized.

[0026] Preferably, the liquid to be atomized is selected from a solution or suspension.

[0027] Preferably, step S1 further includes adding one or more of a solvent, a pressure-resistant protectant, and a heat-resistant protectant to the liquid to be atomized before pressurization and heating.

[0028] Compared with the prior art, the beneficial effects of the present invention are as follows:

[0029] The atomization module provided by this invention includes a pressure-resistant solution chamber, a pressure component, a heating component, and a sealing nozzle. This invention pressurizes and heats the liquid to be atomized in the pressure-resistant solution chamber through the pressure component and the heating component, so that the liquid to be atomized remains in a liquid state even after its temperature exceeds the boiling point under standard atmospheric pressure (hereinafter referred to as "superheated state"). When the liquid to be atomized is continuously pressurized to the point of exceeding the pressure bearing range of the blind hole on the spray plate, the blind hole deforms and ruptures. After passing through the continuously narrowing transition section and the ruptured blind hole opening, the liquid to be atomized is ejected outward to form a continuous micro-liquid column. The micro-liquid column in the superheated state triggers the "flash evaporation" phenomenon due to the significant decrease in environmental pressure, and boils violently in a very short time. The volume change caused by the generation of boiling bubbles and the instantaneous shear force generated by the rupture of the bubble film cause violent fluctuations on the surface of the micro-liquid column, which then disperses and ruptures to form micro-droplets suitable for inhalation drug delivery. This invention employs a different atomization mechanism than existing technologies. By using the atomization module provided by this invention for atomization, the spray quality characteristics remain stable under different doses, and the median aerodynamic particle size of the output droplets is always distributed within the range of 2-5 μm, enabling large-dose atomized drug delivery.

[0030] Compared to traditional jet nebulizers, the nebulization module of this invention offers a faster nebulization rate, improving patient compliance, reducing solution residue, and increasing drug utilization. It also eliminates the need to maintain the nebulizer in a specific position during use. Compared to aerosols, the spray output is not propellant-dependent, making it environmentally friendly and eliminating the risk of needing to adjust medication prescriptions due to environmental requirements. Compared to novel nebulization devices, it offers a wider range of nebulizable solution volumes per spray, allowing for the delivery of both micro- and large doses of medication as needed, thus broadening its applicability.

[0031] Meanwhile, the nozzle component used in this invention has a simple structure and does not rely on high-precision micron-level features or structures to achieve atomization effect. It has low process difficulty and processing cost, and makes it easier to control the price of the final drug. Attached Figure Description

[0032] To make the objectives, technical solutions, and advantages of this invention clearer, the technical solutions of this invention will be described in detail below. Obviously, the described embodiments are merely some embodiments of this invention, and not all embodiments. Based on the embodiments of this invention, all other implementation methods obtained by those skilled in the art without creative effort are within the scope of protection of this invention.

[0033] Figure 1 This is a cross-sectional view of the atomizing module in a specific embodiment of the present invention;

[0034] Figure 2 This is a schematic diagram of the atomization outlet side of the atomization module in a specific embodiment of the present invention;

[0035] Figure 3 This is a schematic diagram of the liquid inlet side of the atomizing module in a specific embodiment of the present invention;

[0036] Figure 4 This is a partial structural diagram of the atomizing module in a specific embodiment of the present invention;

[0037] Figure 5 This is a schematic diagram of the inner diameter of a partial structure of the atomizing module in a specific embodiment of the present invention;

[0038] Figure 6 This is a schematic diagram of the atomizer in a specific embodiment of the present invention;

[0039] Figure 7 This is a distribution characteristic diagram of the spray under rated conditions in the embodiment;

[0040] Figure 8 This is a diagram showing the proportion of fine particles (<5μm) under rated conditions in the embodiments;

[0041] Figure 9This is a distribution diagram of the atomized water mist output quality (n=10) under different atomization capacities in the embodiment;

[0042] Among them, 1 is the atomization module, 2 is the drug storage module, 3 is the control module, 4 is the quantitative liquid delivery module, 5 is the power module, 11 is the pressure-resistant solution chamber, 12 is the sealing nozzle, 13 is the heating component, 14 is the pressure component, 15 is the fastener, 111 is the liquid outlet, 112 is the liquid inlet, 121 is the transition section, 122 is the spray plate, 1221 is the blind hole, 131 is the heat source, 132 is the heat transfer module, 1331 is the temperature control module; 151 is the opening; D1 is the inner diameter of the pressure-resistant solution chamber, D2 is the inner diameter of the transition section, and D3 is the thickness of the blind hole. Detailed Implementation

[0043] The technical solution of the present invention will now be described with reference to the accompanying drawings. Obviously, the described embodiments are only a part of the implementation methods of this application, and not all of them; and the structures shown in the accompanying drawings are merely illustrative and do not represent physical objects. It should be noted that all other embodiments obtained by those skilled in the art based on these embodiments of the present invention are within the scope of protection of this application.

[0044] In this invention, the "inner side" refers to the side relatively close to the opening or blind hole; the "outer side" refers to the side relatively far from the opening or blind hole.

[0045] In this invention, the "superheat temperature" refers to the temperature at which the temperature of the liquid to be atomized is greater than the boiling point at 1 atmosphere; the "superheat state" refers to the state in which the temperature of the liquid to be atomized is superheated and it is in a liquid state; and the "degree of superheat" refers to the temperature difference between the superheat temperature and the boiling point of the liquid to be atomized at 1 atmosphere.

[0046] In this invention, the "blind hole thickness" refers to the distance from the bottom of the groove of the blind hole to the outer side of the spray plate, such as... Figure 5 D3 shown.

[0047] like Figure 1-5 As shown, the present invention provides an atomization module 1 for an atomizer, including a pressure-resistant solution chamber 11, a sealed nozzle 12, a heating component 13, and a pressure component.

[0048] The pressure-resistant solution chamber 11 of this invention is used to hold the liquid to be atomized. This invention ensures that the liquid to be atomized remains in a liquid state within the pressure-resistant solution chamber 11 under pressure. The pressure-resistant solution chamber of this invention can be of any shape, such as cylindrical, cuboid, cube, cone, or irregular. In this invention, the pressure-resistant solution chamber 11 includes an inlet 112 and an outlet 111. The outlet 111 is connected to a sealing nozzle 12, and the inlet 112 is used to connect to a structure that can input the liquid to be atomized (e.g., a metering module 4). This invention does not have a special limitation on the shape of the inlet and / or outlet; in some specific embodiments, the outlet 111 is circular.

[0049] In some specific embodiments of the present invention, the pressure-resistant solution chamber can be made of a material with good drug compatibility and high thermal stability, such as borosilicate glass. In this case, the heat transfer module does not directly contact the solution to be atomized and has no compatibility requirements. It can also be made of other metal materials with better thermal conductivity or lighter weight, such as copper alloys or aluminum alloys, or other non-metallic materials with good thermal conductivity, such as ceramics. In some specific embodiments of the present invention, the capacity of the pressure-resistant solution chamber 11 is between 0.03-0.2 mL, preferably between 0.05-0.1 mL; in some specific embodiments of the present invention, the capacity of the pressure-resistant solution chamber 11 is adjustable.

[0050] The sealing nozzle 12 of this invention includes a transition section 121 and a spray plate 122. The spray plate is provided with an inwardly closed blind hole 1221. The transition section 121, the blind hole 1221, and the liquid outlet 111 are connected. When the pressure exceeds the bearing capacity, the blind hole 1221 opens from the inside to the outside, and the liquid to be atomized is sprayed out from the blind hole 1221. The inner diameters of the pressure-resistant solution chamber 11, the transition section 121, and the blind hole 1221 decrease sequentially. The sealing nozzle 12 cooperates with the pressure-resistant solution chamber 11 to keep the pressure-resistant solution chamber sealed within a certain pressure range, so that the liquid to be atomized in the pressure-resistant solution chamber is pressurized and heated to the superheated temperature. The blind hole 1221 is the weakest point in the sealed space formed by the sealing nozzle 12 and the pressure-resistant solution chamber 11. Therefore, when the pressure of the liquid to be atomized exceeds the pressure bearing capacity of the blind hole, the blind hole deforms under pressure and opens from the inside to the outside, and the liquid to be atomized is sprayed out from the blind hole. As the solution to be atomized bursts through the sealing point on the spray plate, it ejects outward to form a continuous micro-liquid column. At this moment, the superheated liquid, due to the restoration of ambient pressure to standard atmospheric pressure, experiences a drop in boiling point below its own temperature, triggering flash evaporation and violently boiling within a very short time. The volume change caused by the formation of boiling bubbles and the instantaneous shear force generated by the rupture of the bubble film cause violent fluctuations on the surface of the micro-liquid column, which in turn disperses and breaks down to generate micro-droplets for inhalation.

[0051] Besides the inherent characteristics of the surface tension and thermodynamic parameters of the liquid to be atomized, the quality of the water mist output by the atomization module of this invention is mainly determined by the "superheat" of the liquid to be atomized, the initial diameter of the sprayed micro-liquid column, and the single-spray dosage. Superheat is the main determining factor for atomized particle size. When the superheat is 0, there is no flash evaporation, and the liquid is sprayed out as a continuous micro-liquid column without forming water mist. When the superheat is greater than 10°C, the sprayed micro-liquid column begins to disperse into fine water mist, and the aerodynamic particle size of the output water mist decreases accordingly with increasing superheat. The initial micro-liquid column diameter determines the uniformity of the output water mist particle size. The smaller the initial column diameter, the larger the spray diffusion angle when flash evaporation occurs, and the higher the proportion of fine particles in the output water mist. The initial micro-liquid column diameter mainly depends on the diameter of the blind orifice 1221, which is approximately 2-3 times the diameter of the blind orifice 1221.

[0052] like Figure 5 As shown, the inner diameters of the pressure-resistant solution chamber 11, the transition section 121, and the blind hole 1221 decrease sequentially, ensuring that the liquid to be atomized must undergo two consecutive narrowing compressions before being ejected. This increases local pressure, reduces spray pressure, slows down the initial micro-liquid column velocity, and controls the spray duration. In some specific embodiments of the present invention, the inner diameter D1 of the pressure-resistant solution chamber is 2-3 times, preferably 1.5 times, the inner diameter D2 of the transition section. In some specific embodiments of the present invention, the inner diameter of the blind hole is 0.03-0.3 mm, preferably 0.05-0.15 mm; the inner diameter D2 of the transition section is preferably more than 1.5 times the inner diameter of the blind hole. In the present invention, the thickness D3 of the blind hole is usually thinner than other structures of the atomizing module; in some specific embodiments, the thickness of the blind hole can be 0.005-0.02 mm, preferably 0.008-0.015 mm. In some specific embodiments of the present invention, the blind hole 1221 can be made of a polymer material or a metal sheet with several polymer film micropores. The spray sheet or sealing spray described in this invention is typically for single use, and the retaining part can be opened and replaced after deformation.

[0053] In this invention, the transition section 121 and the spray plate 122 are typically integrally formed. In some specific embodiments of this invention, the transition section 121 is wholly or partially disposed within the liquid outlet 111. In some specific embodiments of this invention, the atomizing module preferably also includes a fastener 15, which secures the sealing nozzle 12 to one end of the pressure-resistant solution chamber opening. The fastener 15 has an opening 151 covering the blind hole 1221. The transition section 121 is pressed into the opening area of ​​the fastener, and the edge of the opening provides additional center-directing locking force between the outer boundary of the transition section and the spray plate to further ensure sealing strength. The generally set sealing pressure is 0.1 MPa-0.8 MPa, and the preferred sealing pressure is 0.2 MPa-0.5 MPa; the above pressures are relative pressures. In some specific embodiments of this invention, the sealing nozzle can be made of an elastic material with drug compatibility and thermal stability, such as silicone, or a stainless steel material with good drug compatibility, such as 304, 316, or 316L. In some specific embodiments of the present invention, the inner diameter of the opening 151 is 0.7-1.1 times the outer diameter of the transition section 121, preferably 0.85-0.95 times the outer diameter of the transition section 121. In some preferred embodiments of the present invention, the transition section 121 and the opening 151 are concentric circles.

[0054] In some specific embodiments of the present invention, a plurality of blind holes 1221 may be provided on the spray sheet. The plurality of blind holes 1221 are distributed in a certain pattern within the range corresponding to the inner diameter of the transition section. This can further slow down the spray speed when the spray dose remains unchanged, reduce the residue in the patient's mouth and throat during inhalation, and improve the drug administration effect. Alternatively, it can be combined with increasing the spray pressure to further increase the single spray dose, which is suitable for situations where larger doses are inhaled for drug administration.

[0055] The heating assembly 13 of this invention is used to heat a heat-resistant solution chamber. Preferably, the heating assembly 13 includes a heat source 131, a heat transfer module 132, and a temperature control module 133. In this invention, the heat source 131 is a heating device, the heat transfer module 132 is used to transfer the heat generated by the heat source to the heat-resistant solution chamber, and the temperature control module 133 is used for temperature control. When the heat source 131 is directly connected to the pressure-resistant solution chamber 11, the heat transfer module 132 can be omitted. The liquid to be atomized needs to reach a superheated temperature within the heat-resistant solution chamber. In a further preferred embodiment of this invention, the temperature control module 133 includes a temperature sensor 1331 and a temperature controller 1332. The temperature sensor 1331 can be installed on or inside the heat-resistant solution chamber. The temperature controller 1332 can adjust and open / close the heat source 131 based on the temperature data fed back by the temperature sensor 1331. For example, when the temperature sensor 1331 detects that the temperature of the heat-resistant solution chamber exceeds a preset upper temperature limit, the temperature controller 1332 shuts off the heat source 131. Generally, the superheated temperature is set to 110℃-180℃, and preferably 120℃-150℃. In this invention, in addition to directly sensing the temperature, the temperature sensor 1331 can also indirectly detect the temperature by sensing other parameters, such as calculating the temperature of the heat-resistant solution chamber / heat transfer module based on the change in the resistance of the heat source.

[0056] In some specific embodiments of the present invention, the heat source 131 may be fixed to the heat transfer module 132 and be wholly or partially enclosed by the heat transfer module 132. In some specific embodiments of the present invention, the heat transfer module 132 may wholly or partially enclose the pressure-resistant solution chamber 11. In the present invention, the heat transfer module may be a metal material with good drug compatibility, such as stainless steel 304, 316, or 316L. In some specific embodiments of the present invention, the heat source may be a single-headed or multi-headed ceramic heating rod, a stainless steel heating rod, or a heating wire wound around the heat transfer module 132 externally or woven into a specific shape and fixed inside the heat transfer module. In some specific embodiments of the present invention, the heating power of the heat source 131 is 2-50W.

[0057] The pressure assembly described in this invention is used to control the pressure within a pressure-resistant solution chamber and can employ any liquid pressurization structure known in the art. In some specific embodiments of this invention, the pressure assembly is a liquid pump. The pressure assembly of this invention may also include a pressure detection device and / or an independent pressure control element to pressurize or depressurize the pressure-resistant solution chamber according to a preset or adjusted method.

[0058] The atomization module provided by this invention has stable performance, good repeatability of the output spray under the same conditions, and no significant change in the quality of the output water mist during repeated spraying.

[0059] A second aspect of the present invention provides an nebulizer, comprising an nebulization module 1, a drug storage module 2, a control module 3, a metering liquid delivery module 4, and a power module 5 as described in the above-described technical solution. The control module 3 is connected to the nebulization module 1, the metering liquid delivery module 4, and the power module 5 to control the nebulizer's nebulization. The nebulizer structure provided by the present invention includes one of the nebulization modules described in the above-described technical solution, wherein the control module 3, the metering liquid delivery module 4, and the power module 5 may be omitted in whole or in part. The power module 5 provides energy to the control module 3, the metering liquid delivery module 4, and the heating component 13 in the nebulization module 1. The heating component 13 may also have its own independent power source. The control module 3 is connected to the metering liquid delivery module 4, the nebulization module 1, and the power module 5, and is used to control the opening, closing, and operation of the above modules. The control module 3 can control the pressure component and the heating component within the nebulization module 1, thereby controlling the operation of the nebulization module.

[0060] In some specific embodiments of the present invention, the pressure components in the metering module 4 and the nebulization module 1 can be replaced by a metering pump. The metering module 4 preferably administers 0.03-0.2 mL of liquid per administration, and this dosage can be adjusted in some specific embodiments.

[0061] Preferably, the nebulizer further includes an airflow sensor that can sense the inhalation airflow. When the inhalation airflow is sensed, the nebulization module is automatically activated to spray, thereby realizing automatic sensing-based spray drug delivery.

[0062] A third aspect of the present invention provides an atomization method, implemented using the atomization module or atomizer described in the foregoing technical solutions, comprising the following steps:

[0063] S1. After the atomized liquid enters the pressure-resistant solution chamber, the pressure-resistant solution chamber is pressurized and heated so that the temperature of the atomized liquid in the pressure-resistant solution chamber exceeds its boiling point at standard atmospheric pressure by more than 10°C.

[0064] S2. Continue to pressurize the pressure-resistant solution chamber until the pressure of the liquid to be atomized in the pressure-resistant solution chamber is higher than the preset pressure of the blind hole in the sealed nozzle. At this point, the blind hole deforms and ruptures, and the liquid to be atomized is ejected from the deformed blind hole and atomized.

[0065] The liquid to be nebulized in this invention can be an aqueous solution or an organic solvent, and can be a solution or a suspension. The solvent can be water, physiological saline, ethanol, or other commonly used pharmaceutical solvents, or mixtures of these solvents. The solute is the active pharmaceutical ingredient, such as β-adrenergic receptor agonists, glucocorticoids, or anticholinergic drugs, which are common inhaled medications. The aforementioned solutions or suspensions are applicable to the nebulization module, nebulizer, and nebulization method described in this invention. In some specific embodiments of this invention, to avoid pressurization and heating affecting drug activity, step S1 further includes adding one or more of a solvent, a pressure-resistant protectant, and a heat-resistant protectant to the liquid to be nebulized before pressurization and heating. Examples of such substances include glycerol, propylene glycol, and surfactants used to adjust the fluid's hydrodynamic or thermodynamic properties.

[0066] The technical solutions provided by the present invention will be described in detail below with reference to the embodiments, but they should not be construed as limiting the scope of protection of the present invention. Experimental methods in the following embodiments that do not specify specific conditions are generally performed under conventional conditions or as recommended by the manufacturer.

[0067] Example 1

[0068] like Figure 1-5 As shown, an atomizing module of an atomizer includes a pressure-resistant solution chamber 11, a sealing nozzle 12, a heating assembly 13, a pressure assembly, and a fastener 15. The pressure-resistant solution chamber 11 is a liquid-filled cavity with an outlet 111 and an inlet 112. The sealing nozzle 12 includes a transition section 121 and a spray plate 122. The transition section is a silicone tube with an inner diameter of 0.4-0.6 mm. The spray plate 122 has a blind hole 1221, which is in an inwardly sealed state. The diameter of the blind hole is 0.05-0.15 mm, and the thickness of the blind hole is 0.008-0.015 mm. The centers of the blind hole, the transition section, and the pressure-resistant solution chamber are on the same straight line. The transition section is inserted into the outlet 111. The fastener 15 is located outside the sealing nozzle and has an opening in the area corresponding to the transition section 121. The diameter of the opening is 85-95% of the outer diameter of the transition section.

[0069] The heating assembly 13 includes a 2-50W single-head ceramic heating rod (heat source 131), a 304 stainless steel heat transfer module 132, and a temperature control module 133. The temperature sensor of the heating assembly is a PT100 thermocouple. When the temperature controller senses that the heat transfer block exceeds the set temperature, it stops heating and controls the heat transfer block within the expected temperature range. The overheating temperature is generally set to 110℃-180℃, and the preferred overheating temperature is 120℃-150℃. The heat transfer module 132 is enclosed outside the pressure-resistant solution chamber 11, and the heat source 131 is fixed inside the heat transfer module. The outer surface of the heat source is in close contact with the inside of the heat transfer module to ensure heat conduction efficiency.

[0070] The pressurization component is a liquid pump, which can pressurize the pressure-resistant solution chamber 11. The liquid inlet 112 of the pressure-resistant solution chamber 11 can be connected to a structure that can input liquid so that the liquid to be atomized can enter the pressure-resistant solution chamber.

[0071] Example 2

[0072] like Figure 6 As shown, an nebulizer includes the nebulization module 1, drug storage module 2, control module 3, metering dispensing module 4, and power module 5 described in Example 1. The power module 5 provides energy to the control module, metering dispensing module 4, and heating component 13 in the nebulization module 1. The heating component 13 can also have its own independent power source. The control module 3 is connected to the metering dispensing module 4, nebulization module 1, and power module 5, and is used to control the opening, closing, and operation of these modules. The control module 3 can control the pressure component and heating component within the nebulization module 1, thereby controlling the operation of the nebulization module.

[0073] In use, the metering module 4 is activated by the control module 3. The metering module 4 pumps the rated liquid to be atomized into the pressure-resistant solution chamber 11. The pressure component and heating component 13 are turned on to pressurize and heat the liquid to be atomized in the pressure-resistant solution chamber 11, so that the liquid to be atomized is in a superheated state. When the superheat exceeds 10°C, the pressure component continues to pressurize until the internal pressure exceeds the pressure limit of the blind hole 1221. The liquid to be atomized breaks through the blind hole and sprays out. Due to the decrease in external pressure, flash evaporation is triggered and rapid atomization is achieved. The median output water mist particle size is 2-5μm, which is suitable for atomized drug delivery.

[0074] Example 3

[0075] Physiological saline was atomized using the nebulizer described in Example 2, with a rated superheat temperature of 140°C, a spray pressure of 0.4 MPa, a single spray capacity of 0.05 mL, a sealed nozzle transition section diameter of 0.4 mm, and a blind hole opening diameter of 0.15 mm.

[0076] The atomization results are shown in Table 1 and Figure 7-9 As shown, under standard atmospheric pressure, ambient temperature of 22℃, and relative humidity of <45%, the median aerodynamic particle size of the output water mist is 1.56μm, and the FPF (<5μm) ratio is approximately 89%. The atomization performance is significantly better than that of existing commercially available atomizers.

[0077] Table 1. Physiological saline nebulization performance under standard conditions

[0078]

[0079] Depend on Figure 9As shown in the comparison chart of atomization quality under different atomization capacities, the atomization module provided by the present invention has a wide working range. When the set dose per spray changes, the output spray quality characteristics remain stable, and the median particle size is always distributed between 2 and 5 micrometers.

[0080] The above description is only a preferred embodiment of the present invention. It should be noted that for those skilled in the art, several improvements and modifications can be made without departing from the principle of the present invention, and these improvements and modifications should also be considered within the scope of protection of the present invention.

Claims

1. An atomizing module of an atomizer, characterized in that, The pressure solution cavity, the pressure assembly, the heating assembly and the sealing nozzle are included. The pressure assembly is connected with the pressure solution cavity, and the pressure assembly can increase the pressure in the pressure solution cavity. The sealing nozzle is connected with the liquid outlet on the pressure solution cavity, and the sealing nozzle includes a transition section and a spray piece. The heating assembly can heat the pressure solution cavity. The method for realizing atomization by using the atomization module is composed of the following steps: S1. After the liquid to be atomized enters the pressure solution cavity, the pressure solution cavity is pressurized and heated, so that the temperature of the atomized liquid in the pressure solution cavity exceeds the boiling point of the atomized liquid under the standard atmospheric pressure by more than 10℃; S2. Continue to pressurize the pressure solution cavity until the pressure of the liquid to be atomized in the pressure solution cavity is higher than the preset pressure of the blind hole in the sealing nozzle, the blind hole is deformed and broken, and the liquid to be atomized is sprayed from the deformed blind hole.

2. The atomization module of claim 1, wherein, The inner diameter of the pressure solution cavity is 2-3 times the inner diameter of the transition section.

3. The atomization module of claim 1, wherein, The inner diameter of the blind hole is 0.03-0.3mm, and the inner diameter of the transition section is more than 1.5 times the inner diameter of the blind hole.

4. The atomizing module of claim 1 or 3, wherein, The thickness of the blind hole is 0.005-0.02mm.

5. The atomizing module of claim 1 or 3, wherein, The sealing nozzle is further provided with a fastener, which fastens the sealing nozzle at one end of the opening of the pressure solution cavity, and the fastener is provided with an opening covering the blind hole.

6. The atomization module of claim 1, wherein, The transition section is wholly or partially arranged in the liquid outlet.

7. The atomization module of claim 1, wherein, The heating assembly includes a heat source module, a heat transfer module and a temperature control module; the heat source transmits heat to the pressure solution cavity through the heat transfer module, and the temperature control module is used to control the temperature of the pressure solution cavity and / or the heat transfer module.

8. The atomization module of claim 7, wherein, The heat transfer module wholly or partially covers the pressure solution cavity, or wholly or partially covers the inner side of the pressure solution cavity and the sealing nozzle.

9. The atomization module of claim 7 or 8, wherein, The heat source module is wholly or partially covered by the heat transfer module.

10. The atomization module of claim 1, wherein, The sealing nozzle includes a plurality of blind holes, and the plurality of blind holes are arranged within the corresponding range of the inner diameter of the transition section.

11. An atomiser characterised in that, The atomization module, the medicine storage module, the control module, the liquid dosing module and the power module according to any one of claims 1-10 are included, and the control module is connected with the atomization module, the liquid dosing module and the power module respectively to control the atomization of the atomizer.

12. The atomizer of claim 11, wherein, The atomizer further includes an air flow sensor that can sense the air flow, and the air flow sensor is connected with the control module.

13. The atomizer of claim 11, wherein, The liquid dosing module and the pressure assembly in the atomization module are integrated in one structure.

14. A method for atomizing using the atomizing module according to claims 1-10, characterized in that, The method is composed of the following steps: S1. After the liquid to be atomized enters the pressure solution cavity, the pressure solution cavity is pressurized and heated, so that the temperature of the atomized liquid in the pressure solution cavity exceeds the boiling point of the atomized liquid under the standard atmospheric pressure by more than 10℃; S2. Continue to pressurize the pressure solution cavity until the pressure of the liquid to be atomized in the pressure solution cavity is higher than the preset pressure of the blind hole in the sealing nozzle, the blind hole is deformed and broken, and the liquid to be atomized is sprayed from the deformed blind hole.

15. The method of claim 14, wherein, The liquid to be atomized is selected from a solution or a suspension.

16. The method of claim 14, wherein, Step S1 also includes adding one or more of a solvent, a pressure-resistant protective agent, and a heat-resistant protective agent to the liquid to be atomized before pressurization and heating.

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