WO2023125471A1 - Nebulizer and gasflow guide member thereof - Google Patents

Nebulizer and gasflow guide member thereof Download PDF

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Publication number
WO2023125471A1
WO2023125471A1 PCT/CN2022/142149 CN2022142149W WO2023125471A1 WO 2023125471 A1 WO2023125471 A1 WO 2023125471A1 CN 2022142149 W CN2022142149 W CN 2022142149W WO 2023125471 A1 WO2023125471 A1 WO 2023125471A1
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WIPO (PCT)
Prior art keywords
pharmaceutically acceptable
outlet
acceptable salt
inlet
spray
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PCT/CN2022/142149
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French (fr)
Chinese (zh)
Inventor
贺素敏
林旭其
曹立
游劲松
黄芳芳
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广东东阳光药业有限公司
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Publication of WO2023125471A1 publication Critical patent/WO2023125471A1/en

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M11/00Sprayers or atomisers specially adapted for therapeutic purposes

Definitions

  • the invention belongs to the technical field of medical devices, and in particular relates to an airflow guide, an atomizer, a spray assembly and uses thereof.
  • Nebulization inhalation for chronic obstructive pulmonary disease and asthma is the preferred method of administration recommended by relevant treatment guidelines.
  • the nebulizer nebulizes the liquid medicine into an inhalable liquid with the aerodynamic particle size of most of the droplets being 1-5um. Drops, after oral inhalation, the drug can directly reach the lung lesion, so that the drug can fully produce local effects. The effect provided by this method is more efficient and direct than the general oral drug.
  • the spray port is located at the end of the airflow auxiliary guide, and the lower auxiliary drainage opening is located on the side wall of the gas auxiliary guidance, and then the external air passes through the lower auxiliary drainage opening.
  • the spray is introduced into the auxiliary guiding channel of the auxiliary air flow guide and pushes up the spray that enters the auxiliary guiding channel of the auxiliary air flow guide through the spray opening.
  • the lower auxiliary drainage opening is located in the middle of the auxiliary guiding channel, not all the external air introduced into the auxiliary guiding channel due to negative pressure flows in the predetermined direction, and a small part of the external air will flow in the auxiliary guiding channel.
  • the spray diffuses in the channel and collides with the spray, so that the spray accumulates in a large amount on the inner wall of the auxiliary guiding channel and forms residues, which makes it impossible to accurately control the atomized dosage of the nebulizer.
  • the purpose of the present invention is to provide an airflow guide, an atomizer, a spray assembly and its application, so as to solve the problem that the airflow guide of the nebulizer in the prior art cannot accurately control the nebulizer’s atomized dosage.
  • the problem is to provide an airflow guide, an atomizer, a spray assembly and its application, so as to solve the problem that the airflow guide of the nebulizer in the prior art cannot accurately control the nebulizer’s atomized dosage. The problem.
  • the atomizer airflow guide provided by the present invention includes: a first pipe body, on which a first inlet, a first outlet, and a first guide connecting the first inlet and the first outlet are arranged. Guide passage; second pipe body, the second pipe body is provided with a second inlet, a second outlet and a second guide passage communicating with the second inlet and second outlet; the end of the second pipe body The part is located in the first pipe body, and the second outlet is located between the first inlet and the first outlet.
  • the area ratio of the first inlet and the first outlet is 1:(1-10).
  • the area ratio of the first inlet and the first outlet is 1:(2-5). In some embodiments, the area ratio of the first inlet and the first outlet is 1:(1.8-2.3). In some embodiments, the area ratio of the first inlet and the first outlet is 1:(1.5-3). In some embodiments, the area ratio of the first inlet and the first outlet is 1:1.8. In some embodiments, the area ratio of the first inlet and the first outlet is 1:2.3. In some embodiments, the area ratio of the first inlet and the first outlet is 1:1, or 1:2, or 1:3, or 1:4, or 1:5, or 1:6, Or 1:7, or 1:8, or 1:9, or 1:10, or 1:11, or 1:12.
  • the second outlet end surface is located between the second interface of the first inlet and the first outlet end surface.
  • the first inlet is one or more, and is provided on the side wall of the first pipe body, or is provided at the end of the first guide passage and located in the opposite direction of the first outlet, the first inlet is a standard round, square or other special shape, the angle of the inlet is perpendicular to the side wall of the first pipe body, or other various inclined angles; the first outlet It is arranged at the end of the first pipe body.
  • the first inlet is multiple and surrounds the outer wall of the first tube body, or is located at the end of the first guide channel. The opposite reverse of the first exit.
  • the second inlet is provided with a first installation part, and the installation part is suitable for installing a medicine bottle; the second outlet is provided with a second installation part. part, the second installation part is suitable for installing the atomization module.
  • the second outlet is provided with a second mounting portion which is a stepped hole, and the stepped hole is suitable for placing an atomizing component.
  • the mounting part of the second inlet is provided with a screw hole to facilitate the installation of a medicine bottle
  • the second outlet is provided with a stepped hole to facilitate the installation of an atomizing sheet.
  • the area of the second inlet is 50mm 2 -300mm 2
  • the area of the second outlet is 100mm 2 -300mm 2 .
  • the second pipe body is an elbow, and is suitable for making the angle between the central axis of the second inlet and the central axis of the second outlet 90°-150°.
  • the present invention also discloses an atomizer, which includes the airflow guide described in any one of the above.
  • the above-mentioned atomizer further preferably, further includes: a housing, the housing is detachably connected to the outside of the airflow guide; an atomization module, including an atomization sheet, and the atomization sheet is installed on the The second outlet is suitable for contacting and connecting with the medicine bottle to vibrate and atomize the medicine liquid.
  • the atomizer as described above further preferably, further includes a first gasket, a second gasket and a nozzle pressing plate, and the first gasket, the second gasket and the nozzle pressing plate are sequentially installed at the second outlet from the inside to the outside ; The atomizing sheet is clamped between the first gasket and the second gasket.
  • the present invention also provides a spray assembly, including spray and the aforementioned atomizer, the active ingredients in the spray are ⁇ 2 receptor agonist, glucocorticoid, muscarinic receptor antagonist and phosphodiesterase At least one of the 4 inhibitors.
  • the spray kit comprises a ⁇ 2-receptor agonist single spray.
  • the spray kit comprises a glucocorticoid single spray.
  • the spray kit comprises a muscarinic receptor antagonist single spray.
  • the spray kit comprises a phosphodiesterase 4 inhibitor single spray.
  • the spray assembly comprises a combined spray of a ⁇ 2 receptor agonist and a glucocorticoid.
  • the spray component comprises a combination spray of a ⁇ 2 receptor agonist and a muscarinic receptor antagonist.
  • the spray kit comprises a combined spray of a muscarinic receptor antagonist and a glucocorticoid.
  • the spray kit comprises a tripartite spray of ⁇ 2 receptor agonist, muscarinic receptor antagonist and glucocorticoid.
  • the ⁇ 2 receptor agonists include albuterol or a pharmaceutically acceptable salt thereof, fenoterol or a pharmaceutically acceptable salt thereof, terbutaline or a pharmaceutically acceptable salt thereof, formoste rol or its pharmaceutically acceptable salt, olodaterol or its pharmaceutically acceptable salt, arformoterol or its pharmaceutically acceptable salt, indacaterol or its pharmaceutically acceptable salt, vilanterol or its at least one of the pharmaceutically acceptable salts.
  • the pharmaceutically acceptable salt of salbutamol can be salbutamol sulfate and salbutamol hydrochloride.
  • the pharmaceutically acceptable salt of formoterol may be formoterol fumarate.
  • the pharmaceutically acceptable salt of olodaterol may be olodaterol hydrochloride.
  • the pharmaceutically acceptable salt of arformoterol may be arformoterol tartrate.
  • the pharmaceutically acceptable salt of indacaterol may be indacaterol maleate.
  • the pharmaceutically acceptable salt of vilanterol may be vilanterol triphenylacetate.
  • the glucocorticoids include fluticasone or a pharmaceutically acceptable salt or ester thereof, mometasone or a pharmaceutically acceptable salt or ester thereof, ciclesonide or a pharmaceutically acceptable salt or ester thereof, Clomethasone or a pharmaceutically acceptable salt or ester thereof, flunisolide or a pharmaceutically acceptable salt or ester thereof, budesonide or a pharmaceutically acceptable salt or ester thereof, triamcinolone acetonide or a pharmaceutically acceptable salt thereof or At least one of ester, dexamethasone, or a pharmaceutically acceptable salt or ester thereof.
  • the pharmaceutically acceptable salt of fluticasone may be fluticasone furoate or fluticasone propionate.
  • the pharmaceutically acceptable salt of mometasone may be mometasone furoate.
  • the pharmaceutically acceptable salt of beclomethasone can be beclomethasone dipropionate and beclomethasone dipropionate.
  • the pharmaceutically acceptable salt of dexamethasone can be dexamethasone sodium phosphate.
  • the muscarinic receptor antagonists include tiotropium or a pharmaceutically acceptable salt thereof, glycopyrronium or a pharmaceutically acceptable salt thereof, umeclidinium or a pharmaceutically acceptable salt thereof, uridine At least one of benzinium or a pharmaceutically acceptable salt thereof, ipratropium or a pharmaceutically acceptable salt thereof, oxitropium or a pharmaceutically acceptable salt thereof, revefenacin or a pharmaceutically acceptable salt thereof.
  • the pharmaceutically acceptable salt of tiotropium can be tiotropium bromide.
  • the pharmaceutically acceptable salt of glycopyrronium may be glycopyrronium bromide.
  • the pharmaceutically acceptable salt of umeclidinium can be umeclidinium bromide.
  • the pharmaceutically acceptable salt of umeclidinium can be umeclidinium bromide.
  • the pharmaceutically acceptable salt of ipratropium ammonium can be ipratropium bromide.
  • the pharmaceutically acceptable salt of oxitropium can be oxitropium bromide.
  • the phosphodiesterase 4 inhibitor comprises at least one of roflumilast or a pharmaceutically acceptable derivative thereof, apremilast or a pharmaceutically acceptable derivative thereof.
  • the pharmaceutically acceptable derivative of roflumilast can be roflumilast N-oxide.
  • the present invention also provides a spray assembly, including a spray and the aforementioned atomizer, and the active ingredient in the spray includes at least one of prostacyclin, treprostinil, and iloprost.
  • the present invention also provides a spray assembly, including a spray and the aforementioned atomizer, and the active ingredients in the spray include antibiotics or antiviral drugs.
  • the antibiotics include at least one of aztreonam, tobramycin, amikacin, and ciprofloxacin
  • the antiviral drugs include at least one of zanamivir, laninamivir, and ribavirin.
  • the present invention also provides a spray assembly, including a spray and the aforementioned atomizer, and the active ingredient in the spray includes at least one of pirfenidone and nintedanib.
  • the present invention also provides a spray assembly, including a spray and the aforementioned atomizer, and the active ingredients in the spray include small molecule cytotoxic drugs or biological agents.
  • the small molecule cytotoxic drugs include at least one of cisplatin, cyclophosphamide, etoposide, vinorelbine, and paclitaxel
  • the biological preparations include at least one of ipilimumab monoclonal antibody, nivolumab monoclonal antibody, and durvalumab monoclonal antibody. A sort of.
  • the present invention proposes the use of the aforementioned spray assembly in the preparation of a medicament for treating COPD (chronic obstructive pulmonary disease) and/or asthma.
  • COPD chronic obstructive pulmonary disease
  • the present invention proposes the use of the aforementioned spray assembly in the preparation of medicines for treating pulmonary hypertension.
  • the present invention proposes the use of the aforementioned spray assembly in the preparation of medicine for treating pulmonary infection.
  • the present invention proposes the use of the aforementioned spray assembly in the preparation of a drug for treating idiopathic pulmonary fibrosis.
  • the present invention proposes the use of the aforementioned spray assembly in the preparation of a drug for treating lung cancer.
  • the aforementioned spray assembly can be applied to the systemic administration of small molecule drugs such as levodopa and loxapine; it can also be used for the administration of biological agents such as insulin and insulin analogs, etc. Pulmonary systemic administration.
  • the present invention has the following advantages:
  • the atomizer airflow guide disclosed by the present invention includes a first pipe body and a second pipe body, wherein the first pipe body is provided with a first inlet, a first outlet and a connection between the first inlet and the first outlet.
  • the first guide passage, the second pipe body is provided with a second inlet, a second outlet, and a second guide passage communicating with the second inlet and the second outlet; and the end of the second pipe body is located at the first guide passage In a pipe body, the second outlet is located between the first inlet and the first outlet.
  • the second guiding channel is suitable for guiding the atomized particles into the first guiding channel
  • the first guiding channel is suitable for introducing external air, and using the external air to send the atomized particles into the oral cavity of the human body; and Because the flow path of the external air is to enter the first guide channel through the first inlet and flow out through the first outlet, the second outlet is located between the second interface of the first inlet and the first outlet, so that it enters the first guide channel through the second outlet.
  • the atomized particles in the guide channel are located on the circulation path of the external air, so that the atomized particles entering the first guide channel can be directly entrained by the external air and brought into the oral cavity of the human body.
  • the first inlet on the side wall of the first pipe body, it can also be located at the end of the first guide channel and opposite to the first outlet, combining the positional relationship between the first pipe body and the second pipe body , so that part of the external air forms a backflow due to collision with the side wall of the first pipe body and/or the second pipe body when flowing, and then the forward direction is adjusted so that the forward direction is close to parallel with the inner wall of the first pipe body to avoid fog
  • the retention of atomized particles is reduced, the residue of atomized particles is reduced, and the efficiency of drug administration is improved.
  • the present invention not only satisfies the assembly problem of the first pipe body, the second pipe body and the installation ring, but also makes the first pipe body and the second pipe body
  • the seal at the connection position of the body ensures the original characteristics of the airflow, thereby increasing the content of gas in the direction of deviation during advancement, improving the efficiency of drug delivery, and at the same time making the airflow guide have the functions of anti-fall and anti-disassembly.
  • the present invention also controls the entrance and exit area of the airflow guide and the height of the spray port to ensure that when spraying, at different inhalation volume flow rates, the deposition at the nozzle and the throat of the human body is less and the deposition amount is consistent.
  • Fig. 1 is a three-dimensional structural schematic diagram of an airflow guide of an atomizer in the present invention
  • Fig. 2 is the front view of Fig. 1;
  • Fig. 3 is the cross-sectional structure schematic diagram of Fig. 2;
  • Fig. 4 is a schematic cross-sectional structure diagram of an airflow guide
  • Fig. 5 is an exploded view of the structure of the atomizer in which the first pipe body and the second pipe body are integral parts in the present invention
  • Fig. 6 is a schematic diagram of the opening size of the first inlet 4.
  • Fig. 7 is a schematic cross-sectional structure diagram of a dimension of 4.6 mm from the end face position of the second outlet 7 to the reference plane of the mounting ring;
  • Fig. 8 is a schematic cross-sectional structure diagram of a dimension of 15.7mm from the position of the end face of the second outlet 7 to the reference plane of the mounting ring;
  • Fig. 9 is a schematic cross-sectional structure diagram of a dimension of 20.7 mm from the end face position of the second outlet 7 to the reference plane of the mounting ring;
  • Fig. 10 is a structural schematic diagram of the first inlet 4 at the end (opposite direction of the first inlet) and a mounting ring;
  • Fig. 11 is a structural schematic diagram of the first inlet 4 at the end (opposite direction of the first inlet), and no mounting ring;
  • Fig. 12 is a structural schematic diagram of the first inlet 4 on the side wall and the inlet angle of the inlet hole is inclined;
  • Fig. 13 is an exploded view of the structure of the first pipe body and the second pipe body in different separate parts according to the present invention. Explanation of reference signs:
  • connection should be understood in a broad sense, for example, it can be a fixed connection or a detachable connection, Or integrally connected; it may be mechanically connected or electrically connected; it may be directly connected or indirectly connected through an intermediary, and it may be the internal communication of two components.
  • installation should be understood in a broad sense, for example, it can be a fixed connection or a detachable connection, Or integrally connected; it may be mechanically connected or electrically connected; it may be directly connected or indirectly connected through an intermediary, and it may be the internal communication of two components.
  • the nebulizer flow guide provided in this embodiment includes a first tube body 1 , which is a straight tube and is mainly used for guiding water and communicating with the oral cavity of a human body.
  • the inner cavity of the first pipe body 1 is the first guide channel 6, the port at one end is the first outlet 5, and the side wall of the outer periphery of the other end is provided with a through hole for the first inlet 4.
  • the first pipe body 1 is suitable for guiding external air to flow into the first guide channel 6 from the first inlet 4 at the side wall of the straight tube, and flow out from the first outlet 5 at the end after being guided by the first guide channel 6 into the human mouth.
  • the first tube body 1 is generally used by mouth to realize communication with the oral cavity of the human body, and in order to match the natural opening shape of the oral cavity, the cross section of the first tube body 1 is generally oval.
  • the first tube body 1 is also provided with a raised portion 10 on the outer wall between the first inlet 4 and the first outlet 5 for indicating the maximum oral intake position.
  • the protruding part 10 may be point-shaped or arc-shaped, and in this embodiment it is an annular protrusion.
  • the atomizer flow guide provided in this embodiment also includes a second pipe body 2, which is an elbow with two ends open, and the inner cavity of the elbow is the second guide channel 8, and the two ports are respectively It is the second inlet 11 and the second outlet 7.
  • the curved shape of the second tube body 2 is suitable for adjusting the positional relationship between the medicine bottle and the oral cavity of the human body, so that when the nebulizer deflector is in a normal bite state, the medicine bottle body is in an upright state, which is preferred in this embodiment , the angle between the central axis of the second inlet 11 and the central axis of the second outlet 7 is 130°, of course, the angle can also be other values between 90°-150°.
  • the second inlet 11 is the inlet of the liquid medicine, with an area of 50mm 2 -300mm 2 .
  • the second inlet 11 is provided with an internal thread, and the internal thread is an adaptive connection between the second installation part 9 and the external thread at the mouth of the medicine bottle.
  • the second outlet 7 is an atomized particle outlet with an area of 100mm 2 -300mm 2 , specifically, the second outlet 7 is provided with a first installation part 12 suitable for installation with the atomization sheet, and passes through the first installation part 12 The atomizing sheet is installed, and then through the atomizing sheet, the liquid medicine is sprayed out through the second guiding channel 8 through the second outlet 7 and enters the first guiding channel 6 .
  • the first pipe body 1 and the second pipe body 2 are assembled and connected through the installation ring 3 , preferably, the first pipe body 1 , the second pipe body 2 and the installation ring 3 are integrally formed. Specifically, one side of the mounting ring 3 is connected to the end of the first pipe body 1, and the central hole is set on the outside of the second outlet 7 of the second pipe body 2, forming a connection between the second pipe body 2 and the first pipe body 1.
  • the connection relationship is such that the second outlet 7 is located in the first guide channel 6 and between the first inlet 4 and the first outlet 5 .
  • the height of the second outlet 7 The range is between the second interface and the third interface. Specifically, taking the boundary surface of the installation ring 3 close to the first inlet as the reference plane, the height from the second outlet 7 to the reference plane is greater than the height from the second interface of the first inlet 4 to the reference plane, and less than the height from the end surface of the first outlet 5 to the reference plane. The height of the datum.
  • the height range of the end face of the second outlet 7 is 4.6 mm to 20.7 mm, preferably, the height range of the second outlet 7 to the reference plane is 15.7 mm.
  • the second outlet 7 is located between the first inlet 4 and the first outlet 5, so that the second outlet 7
  • the atomized particles entering the first guiding channel 6 are located on the circulation path of the external air, so that the atomized particles entering the first guiding channel 6 can be directly entrained by the external air and brought into the oral cavity of the human body. It prevents the atomized particles from staying in the first guide channel 6 and then agglomerates, which improves the drug delivery efficiency.
  • the external gas pushes the atomized particles forward, so that the atomized particles are directed in the direction of the external gas, thereby realizing Precise control of the airflow direction of the atomized particles.
  • the airflow guide also has the following functions.
  • the connection position of the first pipe body 1 and the second pipe body 2 is realized.
  • the seal at the position allows external air to enter the first guide passage 6 only from the first inlet 4, so that the airflow guide has the functions of anti-drop damage and anti-demolition.
  • the deposition at the nozzle and the throat of the human body can be achieved under different suction volume flow rates during spraying few.
  • the first pipe body 1 and the second pipe body 2 are split structures, and the assembly connection is realized by optimizing the structures of the first pipe body 1 and the second pipe body 2 .
  • the inner wall of the first inlet 4 in the first pipe body 1 extends inwardly from the inner wall of the other end of the first outlet 5, and the installation platform and the inner wall of the first pipe body 1 form an annular assembly groove;
  • the first pipe body 1 and the second pipe body 2 can be connected by welding, snap-fit structure, screw locking structure or other methods. Fixed connection.
  • the present invention also provides an atomizer.
  • the atomizer also includes a housing 19 , a medicine bottle 20 and an atomization module.
  • the casing 19 is detachably connected to the outside of the airflow guide, not only serving as an installation platform to provide installation space, but also serving as a protective shell to protect the internal structure.
  • the detachable connection method is convenient for separating the airflow guide and the housing 19.
  • the housing 19 and the airflow guide are respectively provided with connection structures that can be detachably connected.
  • the connecting structure on the top can be set on the outside of the first pipe body 1 or the end of the installation ring 3. In this embodiment, it is preferable to set the connection between the installation ring 3 and the shell for fitting and detachment on the other side of the first pipe body 1 relative to the first pipe body 1. Section 13.
  • the medicine bottle 20 can be a medicine bottle that can be connected to the first installation part 12 when it leaves the factory, and can also be a medicine liquid packaging device that can be connected to the first installation part 12 with other bottle mouth specifications. Specifically, the medicine bottle 20 can be connected to the first installation part 12.
  • the sealing ring 18 is in detachable and sealing connection with the second inlet 11 .
  • the atomization module is a mesh atomization module, including an atomization sheet 16 .
  • the atomizing sheet 16 is installed in the second installation part 9 of the second outlet 7 through the first gasket 17, the second gasket 15 and the nozzle pressure plate 14, wherein the first gasket 17, the second gasket 15 and the nozzle pressure plate 14 are from the inside to the The outside is sequentially installed at the second outlet 7, the atomizing sheet 16 is clamped between the first gasket 17 and the second gasket 15; the nozzle pressure plate 14 is fixedly connected with the second pipe body 2 by welding.
  • the atomizing sheet is electrically connected with the drive structure, and is suitable for vibrating under the drive to atomize the liquid medicine;
  • the control switch of the drive structure is arranged on the housing, and is suitable for starting the drive structure through the switch.
  • this embodiment also discloses the use of the above atomizer:
  • the actual test results show that when the area ratio of the first inlet 4 and the first outlet 5 is 1:2.3, the liquid medicine in the nebulizer is in the nebulizer and simulates the suction port of the oropharynx of the human body. , The residue in the tapered mouth and the adapter is small, that is, the amount of atomized particles remaining in the nebulizer and the oropharynx of the human body is small.
  • the delivery efficiency is not affected by the flow rate of the atomized medicinal liquid, that is, it is not affected by the human lung capacity, thereby achieving an excellent inhalation effect; and the area ratio of the first inlet 4 and the first outlet 5 is 1:10, which is obviously 1:2.3 The data is slightly worse.

Abstract

A gasflow guide member, a nebulizer, a spraying assembly and the use of the spraying assembly. The gasflow guide member comprises: a first tube (1), the first tube (1) being provided with a first inlet (4), a first outlet (5), and a first guide channel (6), which makes the first inlet (4) and the first outlet (5) communicate with each other; and a second tube (2), the second tube (2) being provided with a second inlet (11), a second outlet (7), and a second guide channel (8), which makes the second inlet (11) and the second outlet (7) communicate with each other, wherein an end of the second tube (2) is located in the first tube (1), and the second outlet (7) is located between the first inlet (4) and the first outlet (5). The first tube (1) and the second tube (2) may be two different parts, and may also be combined into an integrated part. By means of such a structure, nebulized particles are prevented from staying on an inner wall of the first guide channel (6) and thus agglutinating, thereby improving the efficiency of medication delivery; in addition, the nebulized particles are in the same direction as an advancing direction of external gas, thereby accurately controlling the gasflow direction of the nebulized particles.

Description

一种雾化器及其气流导引件An atomizer and its airflow guide 技术领域technical field
本发明属于医疗器械技术领域,具体涉及一种气流导引件、雾化器、喷雾组件及其用途。The invention belongs to the technical field of medical devices, and in particular relates to an airflow guide, an atomizer, a spray assembly and uses thereof.
背景技术Background technique
雾化吸入治疗慢性阻塞性肺部疾病及哮喘是相关治疗指南推荐的首选给药方式,雾化器将药液雾化为绝大部分液滴空气动力学粒径在1-5um的可吸入液滴,经口吸入后使药物直接到达肺部病灶部位,使药物能充分在局部产生作用,这种方式所提供的效果比一般口服式的药物更有效率且直接。Nebulization inhalation for chronic obstructive pulmonary disease and asthma is the preferred method of administration recommended by relevant treatment guidelines. The nebulizer nebulizes the liquid medicine into an inhalable liquid with the aerodynamic particle size of most of the droplets being 1-5um. Drops, after oral inhalation, the drug can directly reach the lung lesion, so that the drug can fully produce local effects. The effect provided by this method is more efficient and direct than the general oral drug.
现有的雾化器的气流导引件中喷雾口位于气流辅助导引件的端部而下方辅助引流开口位于所示气体辅助导引件的侧壁,然后外部空气穿过下方辅助引流开口而被引入到气流辅助导引件的辅助导引通道内,并推升通过喷雾口进入到气流辅助导引件的辅助导引通道内的喷雾。In the airflow guide of the existing nebulizer, the spray port is located at the end of the airflow auxiliary guide, and the lower auxiliary drainage opening is located on the side wall of the gas auxiliary guidance, and then the external air passes through the lower auxiliary drainage opening. The spray is introduced into the auxiliary guiding channel of the auxiliary air flow guide and pushes up the spray that enters the auxiliary guiding channel of the auxiliary air flow guide through the spray opening.
但是上述结构中,因下方辅助引流开口位于辅助导引通道的中部,因此并非所有因负压被引入到辅助导引通道的外部空气都按照既定的方向流动,少部分外部气体会在辅助导引通道中散开,并与喷雾撞击,使喷雾在辅助导引通道内壁大量集积进而形成残留,进而无法实现精准控制雾化器雾化给药量。However, in the above structure, because the lower auxiliary drainage opening is located in the middle of the auxiliary guiding channel, not all the external air introduced into the auxiliary guiding channel due to negative pressure flows in the predetermined direction, and a small part of the external air will flow in the auxiliary guiding channel. The spray diffuses in the channel and collides with the spray, so that the spray accumulates in a large amount on the inner wall of the auxiliary guiding channel and forms residues, which makes it impossible to accurately control the atomized dosage of the nebulizer.
发明内容Contents of the invention
本发明的目的在于提供一种气流导引件、雾化器、喷雾组件及其用途,以解决现有技术中雾化器的气流导引件无法做到精准控制雾化器雾化给药量的问题。The purpose of the present invention is to provide an airflow guide, an atomizer, a spray assembly and its application, so as to solve the problem that the airflow guide of the nebulizer in the prior art cannot accurately control the nebulizer’s atomized dosage. The problem.
本发明提供的雾化器气流导引件,包括:第一管体,所述第一管体上设有第一进口、第一出口以及连通所述第一进口、第一出口的第一导引通道;第二 管体,所述第二管体上设有第二进口、第二出口以及连通所述第二进口、第二出口的第二导引通道;所述第二管体的端部位于所述第一管体中,并使所述第二出口位于所述第一进口与所述第一出口之间。The atomizer airflow guide provided by the present invention includes: a first pipe body, on which a first inlet, a first outlet, and a first guide connecting the first inlet and the first outlet are arranged. Guide passage; second pipe body, the second pipe body is provided with a second inlet, a second outlet and a second guide passage communicating with the second inlet and second outlet; the end of the second pipe body The part is located in the first pipe body, and the second outlet is located between the first inlet and the first outlet.
如上所述的雾化器气流导引件,所述第一进口和所述第一出口的面积比为1:(1-10)。According to the airflow guide of the atomizer mentioned above, the area ratio of the first inlet and the first outlet is 1:(1-10).
如上所述的雾化器气流导引件,进一步优选为,所述第一进口和所述第一出口的面积比为1:(2-5)。在一些实施方式中,所述第一进口和所述第一出口的面积比为1:(1.8-2.3)。在一些实施方式中,所述第一进口和所述第一出口的面积比为1:(1.5-3)。在一些实施方式中,所述第一进口和所述第一出口的面积比为1:1.8。在一些实施方式中,所述第一进口和所述第一出口的面积比为1:2.3。在一些实施方式中,所述第一进口和所述第一出口的面积比为1:1,或1:2,或1:3,或1:4,或1:5,或1:6,或1:7,或1:8,或1:9,或1:10,或1:11,或1:12。For the airflow guide of the atomizer mentioned above, it is further preferred that the area ratio of the first inlet and the first outlet is 1:(2-5). In some embodiments, the area ratio of the first inlet and the first outlet is 1:(1.8-2.3). In some embodiments, the area ratio of the first inlet and the first outlet is 1:(1.5-3). In some embodiments, the area ratio of the first inlet and the first outlet is 1:1.8. In some embodiments, the area ratio of the first inlet and the first outlet is 1:2.3. In some embodiments, the area ratio of the first inlet and the first outlet is 1:1, or 1:2, or 1:3, or 1:4, or 1:5, or 1:6, Or 1:7, or 1:8, or 1:9, or 1:10, or 1:11, or 1:12.
如上所述的雾化器气流导引件,第二出口端面位于第一进口的第二界面与第一出口端面之间。As mentioned above in the atomizer airflow guide, the second outlet end surface is located between the second interface of the first inlet and the first outlet end surface.
如上所述的雾化器气流导引件,进一步优选为,所述第一进口为一个或多个,设于所述第一管体的侧壁上,或者设于第一导引通道的端部且位于第一出口的相反反向,第一进口为标准的圆形、方形或其他异形,进口的角度垂直于第一管体侧壁,或者是其他各种倾斜角度;所述第一出口设于所述第一管体的端部。As for the airflow guide of the nebulizer as described above, it is further preferred that the first inlet is one or more, and is provided on the side wall of the first pipe body, or is provided at the end of the first guide passage and located in the opposite direction of the first outlet, the first inlet is a standard round, square or other special shape, the angle of the inlet is perpendicular to the side wall of the first pipe body, or other various inclined angles; the first outlet It is arranged at the end of the first pipe body.
如上所述的雾化器气流导引件,进一步优选为,所述第一进口为多个,并环绕于所述第一管体的外壁周圈,或者在第一导引通道的端部位于第一出口的相反反向。For the airflow guide of the atomizer as described above, it is further preferred that the first inlet is multiple and surrounds the outer wall of the first tube body, or is located at the end of the first guide channel. The opposite reverse of the first exit.
如上所述的雾化器气流导引件,进一步优选为,所述第二进口处设有第一安装部,所述安装部适于安装药瓶;所述第二出口出设有第二安装部,所述第二安装部适于安装雾化模块。For the airflow guide of the atomizer as described above, it is further preferred that the second inlet is provided with a first installation part, and the installation part is suitable for installing a medicine bottle; the second outlet is provided with a second installation part. part, the second installation part is suitable for installing the atomization module.
如上所述的雾化器气流导引件,进一步优选为,所述第二出口设有第二安装部为台阶孔,所述台阶孔适于放置雾化组件。In the airflow guide for the nebulizer mentioned above, it is further preferred that the second outlet is provided with a second mounting portion which is a stepped hole, and the stepped hole is suitable for placing an atomizing component.
如上所述的雾化器气流导引件,进一步优选为,所述第二进口的安装部设 有螺孔,便于安装药瓶,所述第二出口设有台阶孔便于安装雾化片。As for the airflow guide of the nebulizer as described above, it is further preferred that the mounting part of the second inlet is provided with a screw hole to facilitate the installation of a medicine bottle, and the second outlet is provided with a stepped hole to facilitate the installation of an atomizing sheet.
如上所述的雾化器气流导引件,进一步优选为,所述第二进口的面积为50mm 2-300mm 2,且第二出口的面积为100mm 2-300mm 2For the airflow guide of the atomizer mentioned above, it is further preferred that the area of the second inlet is 50mm 2 -300mm 2 , and the area of the second outlet is 100mm 2 -300mm 2 .
如上所述的雾化器气流导引件,进一步优选为,所述第二管体为弯管,适于使所述第二进口的中心轴线与所述第二出口的中心轴线之间的角度为90°-150°。In the airflow guide for the atomizer described above, it is further preferred that the second pipe body is an elbow, and is suitable for making the angle between the central axis of the second inlet and the central axis of the second outlet 90°-150°.
本发明还公开了一种雾化器,包括上述任一项所述的气流导引件。The present invention also discloses an atomizer, which includes the airflow guide described in any one of the above.
如上所述的雾化器,进一步优选为,还包括:壳体,所述壳体可拆卸连接于所述气流导引件外侧;雾化模块,包括雾化片,所述雾化片安装于所述第二出口处,适于与药瓶接触连接以震动雾化药液。The above-mentioned atomizer, further preferably, further includes: a housing, the housing is detachably connected to the outside of the airflow guide; an atomization module, including an atomization sheet, and the atomization sheet is installed on the The second outlet is suitable for contacting and connecting with the medicine bottle to vibrate and atomize the medicine liquid.
如上所述的雾化器,进一步优选为,还包括第一垫圈、第二垫圈和喷嘴压板,所述第一垫圈、第二垫圈和喷嘴压板从内到外依次安装于所述第二出口处;所述雾化片夹持在所述第一垫圈和所述第二垫圈之间。The atomizer as described above, further preferably, further includes a first gasket, a second gasket and a nozzle pressing plate, and the first gasket, the second gasket and the nozzle pressing plate are sequentially installed at the second outlet from the inside to the outside ; The atomizing sheet is clamped between the first gasket and the second gasket.
本发明还提供一种喷雾组件,包括喷雾剂和前述的雾化器,所述喷雾剂中的活性成分为β2受体激动剂、糖皮质激素、毒蕈碱受体拮抗剂和磷酸二酯酶4抑制剂中的至少一种。在一些实施方式中,所述喷雾组件包含β2受体激动剂单方喷雾剂。在一些实施方式中,所述喷雾组件包含糖皮质激素单方喷雾剂。在一些实施方式中,所述喷雾组件包含毒蕈碱受体拮抗剂单方喷雾剂。在一些实施方式中,所述喷雾组件包含磷酸二酯酶4抑制剂单方喷雾剂。在一些实施方式中,所述喷雾组件包含β2受体激动剂和糖皮质激素复方喷雾剂。在一些实施方式中,所述喷雾组件包含β2受体激动剂和毒蕈碱受体拮抗剂复方喷雾剂。在一些实施方式中,所述喷雾组件包含毒蕈碱受体拮抗剂和糖皮质激素复方喷雾剂。在一些实施方式中,所述喷雾组件包含β2受体激动剂、毒蕈碱受体拮抗剂和糖皮质激素三方喷雾剂。The present invention also provides a spray assembly, including spray and the aforementioned atomizer, the active ingredients in the spray are β2 receptor agonist, glucocorticoid, muscarinic receptor antagonist and phosphodiesterase At least one of the 4 inhibitors. In some embodiments, the spray kit comprises a β2-receptor agonist single spray. In some embodiments, the spray kit comprises a glucocorticoid single spray. In some embodiments, the spray kit comprises a muscarinic receptor antagonist single spray. In some embodiments, the spray kit comprises a phosphodiesterase 4 inhibitor single spray. In some embodiments, the spray assembly comprises a combined spray of a β2 receptor agonist and a glucocorticoid. In some embodiments, the spray component comprises a combination spray of a β2 receptor agonist and a muscarinic receptor antagonist. In some embodiments, the spray kit comprises a combined spray of a muscarinic receptor antagonist and a glucocorticoid. In some embodiments, the spray kit comprises a tripartite spray of β2 receptor agonist, muscarinic receptor antagonist and glucocorticoid.
在一些实施方式中,所述β2受体激动剂包括沙丁胺醇或其药学可接受的盐、非诺特罗或其药学可接受的盐、特布他林或其药学可接受的盐、福莫特罗 或其药学可接受的盐、奥达特罗或其药学可接受的盐、阿福特罗或其药学可接受的盐、茚达特罗或其药学可接受的盐、维兰特罗或其药学可接受的盐中的至少之一。所述沙丁胺醇药学可接受的盐可以为硫酸沙丁胺醇,盐酸沙丁胺醇。所述福莫特罗药学可接受的盐可以为富马酸福莫特罗。所述奥达特罗药学可接受的盐可以为盐酸奥达特罗。所述阿福特罗药学可接受的盐可以为酒石酸阿福特罗。所述茚达特罗药学可接受的盐可以为马来酸茚达特罗。所述维兰特罗药学可接受的盐可以为三苯乙酸维兰特罗。In some embodiments, the β2 receptor agonists include albuterol or a pharmaceutically acceptable salt thereof, fenoterol or a pharmaceutically acceptable salt thereof, terbutaline or a pharmaceutically acceptable salt thereof, formoste rol or its pharmaceutically acceptable salt, olodaterol or its pharmaceutically acceptable salt, arformoterol or its pharmaceutically acceptable salt, indacaterol or its pharmaceutically acceptable salt, vilanterol or its at least one of the pharmaceutically acceptable salts. The pharmaceutically acceptable salt of salbutamol can be salbutamol sulfate and salbutamol hydrochloride. The pharmaceutically acceptable salt of formoterol may be formoterol fumarate. The pharmaceutically acceptable salt of olodaterol may be olodaterol hydrochloride. The pharmaceutically acceptable salt of arformoterol may be arformoterol tartrate. The pharmaceutically acceptable salt of indacaterol may be indacaterol maleate. The pharmaceutically acceptable salt of vilanterol may be vilanterol triphenylacetate.
在一些实施方式中,所述糖皮质激素包括氟替卡松或其药学可接受的盐或酯、莫米松或其药学可接受的盐或酯、环索奈德或其药学可接受的盐或酯、倍氯米松或其药学可接受的盐或酯、氟尼缩松或其药学可接受的盐或酯、布地奈德或其药学可接受的盐或酯、曲安奈德或其药学可接受的盐或酯、地塞米松或其药学可接受的盐或酯中的至少之一。所述氟替卡松药学可接受的盐可以为糠酸氟替卡松,丙酸氟替卡松。所述莫米松药学可接受的盐可以为糠酸莫米松。所述倍氯米松药学可接受的盐可以为二丙酸倍氯米松,丙酸倍氯米松。所述地塞米松药学可接受的盐可以为地塞米松磷酸钠。In some embodiments, the glucocorticoids include fluticasone or a pharmaceutically acceptable salt or ester thereof, mometasone or a pharmaceutically acceptable salt or ester thereof, ciclesonide or a pharmaceutically acceptable salt or ester thereof, Clomethasone or a pharmaceutically acceptable salt or ester thereof, flunisolide or a pharmaceutically acceptable salt or ester thereof, budesonide or a pharmaceutically acceptable salt or ester thereof, triamcinolone acetonide or a pharmaceutically acceptable salt thereof or At least one of ester, dexamethasone, or a pharmaceutically acceptable salt or ester thereof. The pharmaceutically acceptable salt of fluticasone may be fluticasone furoate or fluticasone propionate. The pharmaceutically acceptable salt of mometasone may be mometasone furoate. The pharmaceutically acceptable salt of beclomethasone can be beclomethasone dipropionate and beclomethasone dipropionate. The pharmaceutically acceptable salt of dexamethasone can be dexamethasone sodium phosphate.
在一些实施方式中,所述毒蕈碱受体拮抗剂包括噻托铵或其药学可接受的盐、格隆铵或其药学可接受的盐、乌美铵或其药学可接受的盐、芜地铵或其药学可接受的盐、异丙托铵或其药学可接受的盐、氧托铵或其药学可接受的盐、revefenacin或其药学可接受的盐中的至少之一。所述噻托铵药学可接受的盐可以为噻托溴铵。所述格隆铵药学可接受的盐可以为格隆溴铵。所述乌美铵药学可接受的盐可以为乌美溴铵。所述芜地铵药学可接受的盐可以为芜地溴铵。所述异丙托铵药学可接受的盐可以为异丙托溴铵。所述氧托铵药学可接受的盐可以为氧托溴铵。In some embodiments, the muscarinic receptor antagonists include tiotropium or a pharmaceutically acceptable salt thereof, glycopyrronium or a pharmaceutically acceptable salt thereof, umeclidinium or a pharmaceutically acceptable salt thereof, uridine At least one of benzinium or a pharmaceutically acceptable salt thereof, ipratropium or a pharmaceutically acceptable salt thereof, oxitropium or a pharmaceutically acceptable salt thereof, revefenacin or a pharmaceutically acceptable salt thereof. The pharmaceutically acceptable salt of tiotropium can be tiotropium bromide. The pharmaceutically acceptable salt of glycopyrronium may be glycopyrronium bromide. The pharmaceutically acceptable salt of umeclidinium can be umeclidinium bromide. The pharmaceutically acceptable salt of umeclidinium can be umeclidinium bromide. The pharmaceutically acceptable salt of ipratropium ammonium can be ipratropium bromide. The pharmaceutically acceptable salt of oxitropium can be oxitropium bromide.
在一些实施方式中,所述磷酸二酯酶4抑制剂包括罗氟司特或其药学可接受的衍生物、阿普斯特或其药学可接受的衍生物中的至少之一。所述罗氟司特 药学可接受的衍生物可以为罗氟司特N-氧化物。In some embodiments, the phosphodiesterase 4 inhibitor comprises at least one of roflumilast or a pharmaceutically acceptable derivative thereof, apremilast or a pharmaceutically acceptable derivative thereof. The pharmaceutically acceptable derivative of roflumilast can be roflumilast N-oxide.
本发明还提供一种喷雾组件,包括喷雾剂和前述的雾化器,所述喷雾剂中的活性成分包括前列环素、曲罗尼尔、伊洛前列素中的至少一种。The present invention also provides a spray assembly, including a spray and the aforementioned atomizer, and the active ingredient in the spray includes at least one of prostacyclin, treprostinil, and iloprost.
本发明还提供一种喷雾组件,包括喷雾剂和前述的雾化器,所述喷雾剂中的活性成分包括抗生素或者抗病毒药物。所述抗生素包括氨曲南、妥布霉素、阿米卡星、环丙沙星中的至少一种,所述抗病毒药物包括扎那米韦、Laninamivir、利巴韦林的至少一种。The present invention also provides a spray assembly, including a spray and the aforementioned atomizer, and the active ingredients in the spray include antibiotics or antiviral drugs. The antibiotics include at least one of aztreonam, tobramycin, amikacin, and ciprofloxacin, and the antiviral drugs include at least one of zanamivir, laninamivir, and ribavirin.
本发明还提供一种喷雾组件,包括喷雾剂和前述的雾化器,所述喷雾剂中的活性成分包括吡非尼酮、尼达尼布中的至少一种。The present invention also provides a spray assembly, including a spray and the aforementioned atomizer, and the active ingredient in the spray includes at least one of pirfenidone and nintedanib.
本发明还提供一种喷雾组件,包括喷雾剂和前述的雾化器,所述喷雾剂中的活性成分包括小分子类细胞毒性药物或者生物制剂。所述小分子类细胞毒性药物包括顺铂、环磷酰胺、依托泊苷、长春瑞滨、紫杉醇中的至少一种,所述生物制剂包括ipilimumab单抗、nivolumab单抗、durvalumab单抗中的至少一种。The present invention also provides a spray assembly, including a spray and the aforementioned atomizer, and the active ingredients in the spray include small molecule cytotoxic drugs or biological agents. The small molecule cytotoxic drugs include at least one of cisplatin, cyclophosphamide, etoposide, vinorelbine, and paclitaxel, and the biological preparations include at least one of ipilimumab monoclonal antibody, nivolumab monoclonal antibody, and durvalumab monoclonal antibody. A sort of.
根据本发明的一方面,本发明提出前述的喷雾组件在制备用于治疗COPD(慢性阻塞性肺疾病)和/或哮喘药物中的用途。According to one aspect of the present invention, the present invention proposes the use of the aforementioned spray assembly in the preparation of a medicament for treating COPD (chronic obstructive pulmonary disease) and/or asthma.
在一些实施方式中,本发明提出前述的喷雾组件在制备用于治疗肺动脉高压药物中的用途。In some embodiments, the present invention proposes the use of the aforementioned spray assembly in the preparation of medicines for treating pulmonary hypertension.
在一些实施方式中,本发明提出前述的喷雾组件在制备用于治疗肺部感染药物中的用途。In some embodiments, the present invention proposes the use of the aforementioned spray assembly in the preparation of medicine for treating pulmonary infection.
在一些实施方式中,本发明提出前述的喷雾组件在制备用于治疗特发性肺纤维化药物中的用途。In some embodiments, the present invention proposes the use of the aforementioned spray assembly in the preparation of a drug for treating idiopathic pulmonary fibrosis.
在一些实施方式中,本发明提出前述的喷雾组件在制备用于治疗肺癌药物中的用途。In some embodiments, the present invention proposes the use of the aforementioned spray assembly in the preparation of a drug for treating lung cancer.
根据本发明的另一方面,前述的喷雾组件可以应用于小分子药物如左旋多巴、洛沙平等的经肺部全身给药;也可以用于生物制剂,如胰岛素及胰岛素类似物等的经肺部全身给药。According to another aspect of the present invention, the aforementioned spray assembly can be applied to the systemic administration of small molecule drugs such as levodopa and loxapine; it can also be used for the administration of biological agents such as insulin and insulin analogs, etc. Pulmonary systemic administration.
本发明与现有技术相比具有以下的优点:Compared with the prior art, the present invention has the following advantages:
本发明所公开的雾化器气流导引件包括第一管体和第二管体,其中第一管体上设有第一进口、第一出口以及连通所述第一进口、第一出口的第一导引通道,第二管体上设有第二进口、第二出口以及连通所述第二进口、第二出口的第二导引通道;且第二管体的端部位于所述第一管体中,并使所述第二出口位于所述第一进口与所述第一出口之间。上述结构中,第二导引通道适于将雾化颗粒导引至第一导引通道中,第一导引通道适于引入外部空气,利用外部空气将雾化颗粒送入人体口腔中;又因为外部空气的流动路径为经第一进口进入第一导引通道并经第一出口流出,第二出口位于第一进口第二界面和第一出口之间,使得经第二出口进入到第一导引通道内的雾化颗粒位于外部空气的流通路径上,进而使得进入第一导引通道的雾化颗粒能够直接被外部空气裹挟并带入到人体口腔中,一方面避免了雾化颗粒在第一导引通道内停留进而凝集,提高了给药效率,另一方面,外部气体推动雾化颗粒前进,使雾化颗粒以外部气体的前进方向为方向,进而实现了对雾化颗粒气流方向的精准控制。The atomizer airflow guide disclosed by the present invention includes a first pipe body and a second pipe body, wherein the first pipe body is provided with a first inlet, a first outlet and a connection between the first inlet and the first outlet. The first guide passage, the second pipe body is provided with a second inlet, a second outlet, and a second guide passage communicating with the second inlet and the second outlet; and the end of the second pipe body is located at the first guide passage In a pipe body, the second outlet is located between the first inlet and the first outlet. In the above structure, the second guiding channel is suitable for guiding the atomized particles into the first guiding channel, and the first guiding channel is suitable for introducing external air, and using the external air to send the atomized particles into the oral cavity of the human body; and Because the flow path of the external air is to enter the first guide channel through the first inlet and flow out through the first outlet, the second outlet is located between the second interface of the first inlet and the first outlet, so that it enters the first guide channel through the second outlet. The atomized particles in the guide channel are located on the circulation path of the external air, so that the atomized particles entering the first guide channel can be directly entrained by the external air and brought into the oral cavity of the human body. Staying in the first guide channel and agglomerating improves the efficiency of drug administration. On the other hand, the external air pushes the atomized particles forward, making the atomized particles take the direction of the external gas as the direction, thereby realizing the adjustment of the airflow direction of the atomized particles. precise control.
本发明通过将第一进口设置在第一管体的侧壁,也可在第一导引通道的端部且位于第一出口的相反反向,结合第一管体和第二管体位置关系,使得部分外部空气因为流动时与第一管体和/或第二管体的侧壁发生撞击而形成回流,进而前进方向发生调整,使前进方向接近与第一管体内侧壁平行,避免雾化颗粒的滞留,降低雾化颗粒残留,提高了给药效率。In the present invention, by arranging the first inlet on the side wall of the first pipe body, it can also be located at the end of the first guide channel and opposite to the first outlet, combining the positional relationship between the first pipe body and the second pipe body , so that part of the external air forms a backflow due to collision with the side wall of the first pipe body and/or the second pipe body when flowing, and then the forward direction is adjusted so that the forward direction is close to parallel with the inner wall of the first pipe body to avoid fog The retention of atomized particles is reduced, the residue of atomized particles is reduced, and the efficiency of drug administration is improved.
本发明通过设置安装环并使安装环与第一管体、第二管体一体成型,不仅满足第一管体、第二管体以及安装环的装配问题,使第一管体与第二管体的连接位置处密封保证了气流的原有特性,进而提高前进中方向偏移气体的含量,提高了给药效率,同时还使得气流导引件具有防跌、防拆功能。The present invention not only satisfies the assembly problem of the first pipe body, the second pipe body and the installation ring, but also makes the first pipe body and the second pipe body The seal at the connection position of the body ensures the original characteristics of the airflow, thereby increasing the content of gas in the direction of deviation during advancement, improving the efficiency of drug delivery, and at the same time making the airflow guide have the functions of anti-fall and anti-disassembly.
本发明还通过设计气流导引件的进出面积与喷雾口的高度控制,保证喷雾时,在不同吸入体积流速下,喷嘴处及人体咽喉部的沉积少且沉积量一致。The present invention also controls the entrance and exit area of the airflow guide and the height of the spray port to ensure that when spraying, at different inhalation volume flow rates, the deposition at the nozzle and the throat of the human body is less and the deposition amount is consistent.
附图说明Description of drawings
为了更清楚地说明本发明具体实施方式或技术方案,下面将对具体实施方式中所需要使用的附图作简单地介绍,显而易见地,下面描述中的附图是本发明的一些实施方式,对于本领域普通技术人员来讲,在不付出创造性劳动的前 提下,还可以根据这些附图获得其他的附图。In order to more clearly illustrate the specific implementation methods or technical solutions of the present invention, the accompanying drawings that need to be used in the specific implementation methods will be briefly introduced below. Obviously, the accompanying drawings in the following description are some implementation methods of the present invention. For Those of ordinary skill in the art can also obtain other drawings based on these drawings without making creative efforts.
图1为本发明中一种雾化器气流导引件的立体结构示意图;Fig. 1 is a three-dimensional structural schematic diagram of an airflow guide of an atomizer in the present invention;
图2为图1的主视图;Fig. 2 is the front view of Fig. 1;
图3为图2的剖面结构示意图;Fig. 3 is the cross-sectional structure schematic diagram of Fig. 2;
图4为气流导引件的剖面结构示意图;Fig. 4 is a schematic cross-sectional structure diagram of an airflow guide;
图5为本发明中第一管体与第二管体为一体化零件的雾化器的结构爆炸图;Fig. 5 is an exploded view of the structure of the atomizer in which the first pipe body and the second pipe body are integral parts in the present invention;
图6为第一进口4开口大小示意图;Fig. 6 is a schematic diagram of the opening size of the first inlet 4;
图7为第二出口7端面位置到安装环基准面尺寸为4.6mm的剖面结构示意图;Fig. 7 is a schematic cross-sectional structure diagram of a dimension of 4.6 mm from the end face position of the second outlet 7 to the reference plane of the mounting ring;
图8为第二出口7端面位置到安装环基准面尺寸为15.7mm的剖面结构示意图;Fig. 8 is a schematic cross-sectional structure diagram of a dimension of 15.7mm from the position of the end face of the second outlet 7 to the reference plane of the mounting ring;
图9为第二出口7端面位置到安装环基准面尺寸为20.7mm的剖面结构示意图;Fig. 9 is a schematic cross-sectional structure diagram of a dimension of 20.7 mm from the end face position of the second outlet 7 to the reference plane of the mounting ring;
图10为第一进口4在端部(第一进口的相反方向),且有安装环的结构示意图;Fig. 10 is a structural schematic diagram of the first inlet 4 at the end (opposite direction of the first inlet) and a mounting ring;
图11为第一进口4在端部(第一进口的相反方向),且无安装环的结构示意图;Fig. 11 is a structural schematic diagram of the first inlet 4 at the end (opposite direction of the first inlet), and no mounting ring;
图12为第一进口4在侧壁且进口孔的入口角度倾斜的结构示意图;Fig. 12 is a structural schematic diagram of the first inlet 4 on the side wall and the inlet angle of the inlet hole is inclined;
图13为本发明种第一管体与第二管体为不同单独零件的结构爆炸图。附图标记说明:Fig. 13 is an exploded view of the structure of the first pipe body and the second pipe body in different separate parts according to the present invention. Explanation of reference signs:
1-第一管体,2-第二管体,3-安装环,4-第一进口,5-第一出口,6-第一导引通道,7-第二出口,8-第二导引通道,9-第二安装部,10-凸起部,11-第二进口,12-第一安装部,13-连接部,14-喷嘴压板,15-第二垫圈,16-雾化片,17-第一垫圈,18-密封圈,19-壳体,20-药瓶。1-First pipe body, 2-Second pipe body, 3-Installation ring, 4-First inlet, 5-First outlet, 6-First guide channel, 7-Second outlet, 8-Second guide Guide channel, 9-second installation part, 10-protruding part, 11-second inlet, 12-first installation part, 13-connection part, 14-nozzle pressure plate, 15-second gasket, 16-atomizing sheet , 17-first gasket, 18-sealing ring, 19-housing, 20-medicine bottle.
具体实施方式Detailed ways
下面将结合附图对本发明的技术方案进行清楚、完整地描述,显然,所描 述的实施例是本发明一部分实施例,而不是全部的实施例。基于本发明中的实施例,本领域普通技术人员在没有做出创造性劳动前提下所获得的所有其他实施例,都属于本发明保护的范围。The technical solutions of the present invention will be clearly and completely described below in conjunction with the accompanying drawings. Apparently, the described embodiments are some of the embodiments of the present invention, rather than all of them. Based on the embodiments of the present invention, all other embodiments obtained by persons of ordinary skill in the art without making creative efforts belong to the protection scope of the present invention.
在本发明的描述中,需要说明的是,术语“中心”、“上”、“下”、“左”、“右”、“竖直”、“水平”、“内”、“外”等指示的方位或位置关系为基于附图所示的方位或位置关系,仅是为了便于描述本发明和简化描述,而不是指示或暗示所指的装置或元件必须具有特定的方位、以特定的方位构造和操作,因此不能理解为对本发明的限制。此外,术语“第一”、“第二”、“第三”仅用于描述目的,而不能理解为指示或暗示相对重要性。In the description of the present invention, it should be noted that the terms "center", "upper", "lower", "left", "right", "vertical", "horizontal", "inner", "outer" etc. The indicated orientation or positional relationship is based on the orientation or positional relationship shown in the drawings, and is only for the convenience of describing the present invention and simplifying the description, rather than indicating or implying that the referred device or element must have a specific orientation, or in a specific orientation. construction and operation, therefore, should not be construed as limiting the invention. In addition, the terms "first", "second", and "third" are used for descriptive purposes only, and should not be construed as indicating or implying relative importance.
在本文描述中,需要说明的是,除非另有明确的规定和限定,术语“安装”、“相连”、“连接”应做广义理解,例如,可以是固定连接,也可以是可拆卸连接,或一体地连接;可以是机械连接,也可以是电连接;可以是直接相连,也可以通过中间媒介间接相连,可以是两个元件内部的连通。对于本领域的普通技术人员而言,可以具体情况理解所述术语在本文具体含义。In this description, it should be noted that, unless otherwise specified and limited, the terms "installation", "connection" and "connection" should be understood in a broad sense, for example, it can be a fixed connection or a detachable connection, Or integrally connected; it may be mechanically connected or electrically connected; it may be directly connected or indirectly connected through an intermediary, and it may be the internal communication of two components. Those of ordinary skill in the art can understand the specific meanings of the terms herein in specific situations.
如图1至图4所示,本实施例所提供的雾化器导流件包括第一管体1,第一管体1为平直管,主要用于导流以及与人体口腔连通。As shown in FIGS. 1 to 4 , the nebulizer flow guide provided in this embodiment includes a first tube body 1 , which is a straight tube and is mainly used for guiding water and communicating with the oral cavity of a human body.
具体的,第一管体1的内腔为第一导引通道6,一端端口为第一出口5,另一端外周的侧壁上开设有用作第一进口4的通孔,进一步的,第一进口4为多个,多个第一进口4呈环状周向间隔布设于平直管的侧壁上。第一管体1适于引导外部空气从平直管侧壁处的第一进口4流入第一导引通道6,并经第一导引通道6导引后从端部的第一出口5流出至人体口腔中。Specifically, the inner cavity of the first pipe body 1 is the first guide channel 6, the port at one end is the first outlet 5, and the side wall of the outer periphery of the other end is provided with a through hole for the first inlet 4. Further, the first There are multiple inlets 4, and the multiple first inlets 4 are arranged on the side wall of the straight pipe at circumferential intervals in an annular shape. The first pipe body 1 is suitable for guiding external air to flow into the first guide channel 6 from the first inlet 4 at the side wall of the straight tube, and flow out from the first outlet 5 at the end after being guided by the first guide channel 6 into the human mouth.
第一管体1一般通过口含使用以实现与人体口腔连通,且为了配合口腔自然张开形状,第一管体1的断面一般为椭圆形。此外,为了避免口含时遮挡第一进口4,第一管体1还于第一进口4和第一出口5之间的外侧壁上设有用于提示最大口含位置的凸起部10。凸起部10可以为点状,还可以为弧形,本实施例中为环状凸起。The first tube body 1 is generally used by mouth to realize communication with the oral cavity of the human body, and in order to match the natural opening shape of the oral cavity, the cross section of the first tube body 1 is generally oval. In addition, in order to avoid blocking the first inlet 4 during oral intake, the first tube body 1 is also provided with a raised portion 10 on the outer wall between the first inlet 4 and the first outlet 5 for indicating the maximum oral intake position. The protruding part 10 may be point-shaped or arc-shaped, and in this embodiment it is an annular protrusion.
本实施例所提供的雾化器导流件还包括第二管体2,第二管体2为两端开口的弯管,弯管的内腔即为第二导引通道8,两端口分别为第二进口11和第二出口7。具体的,第二管体2弯曲形状适于调整药瓶和人体口腔的位置关系, 进而使雾化器导流件处于正常的咬合状态时,药瓶瓶身呈竖立状态,优选本实施例中,第二进口11的中心轴线与第二出口7的中心轴线之间的角度为130°,当然其角度还可以是90°-150°之间的其他值。第二进口11为药液进口,面积为50mm 2-300mm 2,具体的,第二进口11处设有内螺纹,内螺纹为第二安装部9与药瓶瓶口处的外螺纹适配连接,第二出口7为雾化颗粒出口,面积为100mm 2-300mm 2,具体的,第二出口7处设有适于与雾化片安装的第一安装部12,并通过第一安装部12安装雾化片,进而通过雾化片对经第二导引通道8药液经第二出口7处喷出,进入到第一导引通道6中。 The atomizer flow guide provided in this embodiment also includes a second pipe body 2, which is an elbow with two ends open, and the inner cavity of the elbow is the second guide channel 8, and the two ports are respectively It is the second inlet 11 and the second outlet 7. Specifically, the curved shape of the second tube body 2 is suitable for adjusting the positional relationship between the medicine bottle and the oral cavity of the human body, so that when the nebulizer deflector is in a normal bite state, the medicine bottle body is in an upright state, which is preferred in this embodiment , the angle between the central axis of the second inlet 11 and the central axis of the second outlet 7 is 130°, of course, the angle can also be other values between 90°-150°. The second inlet 11 is the inlet of the liquid medicine, with an area of 50mm 2 -300mm 2 . Specifically, the second inlet 11 is provided with an internal thread, and the internal thread is an adaptive connection between the second installation part 9 and the external thread at the mouth of the medicine bottle. , the second outlet 7 is an atomized particle outlet with an area of 100mm 2 -300mm 2 , specifically, the second outlet 7 is provided with a first installation part 12 suitable for installation with the atomization sheet, and passes through the first installation part 12 The atomizing sheet is installed, and then through the atomizing sheet, the liquid medicine is sprayed out through the second guiding channel 8 through the second outlet 7 and enters the first guiding channel 6 .
第一管体1和第二管体2通过安装环3进行装配连接,优选的,使第一管体1、第二管体2与安装环3一体成型。具体的,安装环3的一个侧面连接于第一管体1的端部,中心孔套装于第二管体2的第二出口7端外侧,形成第二管体2与第一管体1的连接关系,使第二出口7置于位于第一导引通道6中,并位于第一进口4与第一出口5之间。以第一进口4的最下端为第一界面,以第一进口4靠近第一出口5方向的边线为第二界面,再以第一出口5的端面为第三界面,第二出口7的高度范围在第二界面和第三界面之间。具体的,以安装环3靠近第一进口的边界面为基准面,第二出口7到基准面的高度大于第一进口4的第二界面到基准面的高度,且小于第一出口5端面到基准面的高度。对应的在本实施例中第二出口7端面的高度值范围为4.6mm到20.7mm,优选的,第二出口7到基准面的高度范围为15.7mm。The first pipe body 1 and the second pipe body 2 are assembled and connected through the installation ring 3 , preferably, the first pipe body 1 , the second pipe body 2 and the installation ring 3 are integrally formed. Specifically, one side of the mounting ring 3 is connected to the end of the first pipe body 1, and the central hole is set on the outside of the second outlet 7 of the second pipe body 2, forming a connection between the second pipe body 2 and the first pipe body 1. The connection relationship is such that the second outlet 7 is located in the first guide channel 6 and between the first inlet 4 and the first outlet 5 . Taking the lowermost end of the first inlet 4 as the first interface, taking the edge of the first inlet 4 close to the first outlet 5 as the second interface, and taking the end face of the first outlet 5 as the third interface, the height of the second outlet 7 The range is between the second interface and the third interface. Specifically, taking the boundary surface of the installation ring 3 close to the first inlet as the reference plane, the height from the second outlet 7 to the reference plane is greater than the height from the second interface of the first inlet 4 to the reference plane, and less than the height from the end surface of the first outlet 5 to the reference plane. The height of the datum. Correspondingly, in this embodiment, the height range of the end face of the second outlet 7 is 4.6 mm to 20.7 mm, preferably, the height range of the second outlet 7 to the reference plane is 15.7 mm.
因为外部空气的流动方向为经第一进口4进入第一导引通道6并经第一出口5流出,第二出口7位于第一进口4和第一出口5之间,使得经第二出口7进入到第一导引通道6内的雾化颗粒位于外部空气的流通路径上,进而使得进入第一导引通道6的雾化颗粒能够直接被外部空气裹挟并带入到人体口腔中,一方面避免了雾化颗粒在第一导引通道6内停留进而凝集,提高了给药效率,另一方面,外部气体推动雾化颗粒前进,使雾化颗粒以外部气体的前进方向为方向,进而实现了对雾化颗粒气流方向的精准控制。Because the flow direction of the external air is to enter the first guide channel 6 through the first inlet 4 and flow out through the first outlet 5, the second outlet 7 is located between the first inlet 4 and the first outlet 5, so that the second outlet 7 The atomized particles entering the first guiding channel 6 are located on the circulation path of the external air, so that the atomized particles entering the first guiding channel 6 can be directly entrained by the external air and brought into the oral cavity of the human body. It prevents the atomized particles from staying in the first guide channel 6 and then agglomerates, which improves the drug delivery efficiency. On the other hand, the external gas pushes the atomized particles forward, so that the atomized particles are directed in the direction of the external gas, thereby realizing Precise control of the airflow direction of the atomized particles.
同时,外部空气从设于第一管体1侧壁上的第一进口4进入到第一导引通道6中,第二出口7位于第一进口4与第一出口5之间,使得部分经第一进口4进入到第一导引通道6的外部空气会与第二管体2的侧壁发生撞击,进而前 进方向发生调整,方向调整接近和第一管体平行,外部空气与第二出口7喷射的雾化颗粒相遇并裹挟该区域内的雾化颗粒前进,进而降低雾化颗粒残留,提高了给药效率。At the same time, external air enters the first guide channel 6 from the first inlet 4 provided on the side wall of the first pipe body 1, and the second outlet 7 is located between the first inlet 4 and the first outlet 5, so that part of the The external air entering the first guide channel 6 from the first inlet 4 will collide with the side wall of the second pipe body 2, and then the direction of advancement will be adjusted. 7. The sprayed atomized particles meet and engulf the atomized particles in the area to advance, thereby reducing the residue of atomized particles and improving the drug delivery efficiency.
且由于第一管体1、第二管体2与安装环3为一体成型结构,使得气流导引件还具有以下功能,一方面,实现了第一管体1、第二管体2连接位置处的密封,使外部气体只从第一进口4进入第一导引通道6中,使得气流导引件具有抗跌破坏和防拆功能。And because the first pipe body 1, the second pipe body 2 and the mounting ring 3 are integrally formed, the airflow guide also has the following functions. On the one hand, the connection position of the first pipe body 1 and the second pipe body 2 is realized. The seal at the position allows external air to enter the first guide passage 6 only from the first inlet 4, so that the airflow guide has the functions of anti-drop damage and anti-demolition.
通过优化气流导引件中第二出口7相对于安装环3的高度以及第一进口4、第一出口5的面积比,实现喷雾时,不同吸入体积流速下,喷嘴处及人体咽喉部的沉积少。By optimizing the height of the second outlet 7 in the airflow guide relative to the installation ring 3 and the area ratio of the first inlet 4 and the first outlet 5, the deposition at the nozzle and the throat of the human body can be achieved under different suction volume flow rates during spraying few.
在本申请的另一个实施例中,第一管体1和第二管体2为分体结构,并通过对第一管体1和第二管体2结构进行优化实现装配连接。具体的,第一管体1中第一进口4相对于第一出口5的另一端的内壁处向内延伸有环形安装台,安装台与第一管体1的内壁形成环形的装配槽;第二管体2的外壁处向外延伸有装配环,装配环与装配槽适配连接,可采用焊接、扣合结构、螺丝锁付结构或其他方式使第一管体1与第二管体2固定连接。In another embodiment of the present application, the first pipe body 1 and the second pipe body 2 are split structures, and the assembly connection is realized by optimizing the structures of the first pipe body 1 and the second pipe body 2 . Specifically, the inner wall of the first inlet 4 in the first pipe body 1 extends inwardly from the inner wall of the other end of the first outlet 5, and the installation platform and the inner wall of the first pipe body 1 form an annular assembly groove; There is an assembly ring extending outward from the outer wall of the second pipe body 2, and the assembly ring is adapted to connect with the assembly groove. The first pipe body 1 and the second pipe body 2 can be connected by welding, snap-fit structure, screw locking structure or other methods. Fixed connection.
进一步的,如图5所示,本发明还提供了一种雾化器,除包括上述的气流导引件之外,雾化器还包括壳体19、药瓶20和雾化模块。Further, as shown in FIG. 5 , the present invention also provides an atomizer. In addition to the airflow guide mentioned above, the atomizer also includes a housing 19 , a medicine bottle 20 and an atomization module.
壳体19可拆卸地连接于气流导引件的外侧,不仅可作为安装平台以提供安装空间,还可以作为保护壳以保护内部结构。可拆卸连接方式则便于分离气流导引件和壳体19,为了实现可拆卸连接方式,壳体19和气流导引件上分别设有可对应拆卸连接的连接结构,具体的,气流导引件上的连接结构可设于第一管体1外侧或安装环3端部,本实施例中优选在安装环3相对于第一管体1的另一侧设置与壳体适配拆装的连接部13。The casing 19 is detachably connected to the outside of the airflow guide, not only serving as an installation platform to provide installation space, but also serving as a protective shell to protect the internal structure. The detachable connection method is convenient for separating the airflow guide and the housing 19. In order to realize the detachable connection, the housing 19 and the airflow guide are respectively provided with connection structures that can be detachably connected. Specifically, the airflow guide The connecting structure on the top can be set on the outside of the first pipe body 1 or the end of the installation ring 3. In this embodiment, it is preferable to set the connection between the installation ring 3 and the shell for fitting and detachment on the other side of the first pipe body 1 relative to the first pipe body 1. Section 13.
药瓶20可以为出厂时配套设置的能够与第一安装部12连接的药瓶,也可以为其他瓶口规格能够与第一安装部12连接的药液包装器,具体的,药瓶20通过密封圈18与第二进口11可拆卸密封连接。The medicine bottle 20 can be a medicine bottle that can be connected to the first installation part 12 when it leaves the factory, and can also be a medicine liquid packaging device that can be connected to the first installation part 12 with other bottle mouth specifications. Specifically, the medicine bottle 20 can be connected to the first installation part 12. The sealing ring 18 is in detachable and sealing connection with the second inlet 11 .
雾化模块为网式雾化模块,包括雾化片16。雾化片16通过第一垫圈17、第二垫圈15和喷嘴压板14安装于第二出口7的第二安装部9中,其中,第一 垫圈17、第二垫圈15和喷嘴压板14从内到外依次安装于第二出口7处,雾化片16夹持在第一垫圈17和第二垫圈15之间;喷嘴压板14通过焊接的方式与第二管体2固定连接。The atomization module is a mesh atomization module, including an atomization sheet 16 . The atomizing sheet 16 is installed in the second installation part 9 of the second outlet 7 through the first gasket 17, the second gasket 15 and the nozzle pressure plate 14, wherein the first gasket 17, the second gasket 15 and the nozzle pressure plate 14 are from the inside to the The outside is sequentially installed at the second outlet 7, the atomizing sheet 16 is clamped between the first gasket 17 and the second gasket 15; the nozzle pressure plate 14 is fixedly connected with the second pipe body 2 by welding.
雾化片与驱动结构电连接,适于在其驱动下震动以雾化药液;驱动结构的控制开关设于壳体上,适于通过开关启动驱动结构。The atomizing sheet is electrically connected with the drive structure, and is suitable for vibrating under the drive to atomize the liquid medicine; the control switch of the drive structure is arranged on the housing, and is suitable for starting the drive structure through the switch.
具体的,本实施例还公开了上述雾化器的使用方式:Specifically, this embodiment also discloses the use of the above atomizer:
将装有药液的药瓶安装至第二管体2上,将壳体安装至第一管体1外侧;药液通过第二进口11引流至第二引流通道中,至第二出口7处,通过控制开关启动雾化模块使第二引流通道中的药液雾化,经过第二出口7处的雾化片雾化的颗粒进入到第一导引通道6的中部;同时,外部空气因负压作用经第一进口4进入到第一导引通道6并与雾化颗粒相遇,进而带动雾化颗粒进入口腔。Install the medicine bottle containing the medicine solution on the second tube body 2, and install the shell on the outside of the first tube body 1; the medicine solution is drained into the second drainage channel through the second inlet 11, and reaches the second outlet 7 , start the atomization module through the control switch to atomize the liquid medicine in the second drainage channel, and the atomized particles through the atomization sheet at the second outlet 7 enter the middle of the first guiding channel 6; at the same time, the external air is The negative pressure enters the first guide channel 6 through the first inlet 4 and meets the atomized particles, thereby driving the atomized particles into the oral cavity.
1.实施例如图1和图8,基于上述网式雾化器气流导引件,第二出口7端面到安装环的基准面距离为15.7mm,对第一进口面积4和第一出口5面积比值分别为1:12;1:5;1:1.8进行了以下吸入测试,具体数据如下:1. Embodiments such as Fig. 1 and Fig. 8, based on the airflow guide of the above-mentioned mesh atomizer, the distance from the end face of the second outlet 7 to the reference plane of the mounting ring is 15.7mm, and the area of the first inlet 4 and the area of the first outlet 5 The ratios were 1:12; 1:5; 1:1.8. The following inhalation tests were carried out, and the specific data are as follows:
Figure PCTCN2022142149-appb-000001
Figure PCTCN2022142149-appb-000001
根据上述实施例测试结果得知,在体积流速为28.3L/min,当第一进口4和第一出口5的面积比由小变大时,雾化器中药液在雾化器中和模拟人体口咽部的吸入口、锥形口和适配器中的残留较小,即雾化颗粒在雾化器和人体的口咽部残留量小。According to the test results of the above examples, it is known that when the volumetric flow rate is 28.3 L/min, when the area ratio of the first inlet 4 and the first outlet 5 changes from small to large, the liquid medicine in the nebulizer and the simulated The residues in the suction port, tapered mouth and adapter of the oropharynx of the human body are small, that is, the residual amount of atomized particles in the nebulizer and the oropharynx of the human body is small.
2.实施例如图13,当第一进口4和第一出口5的面积比为1:2.3和1:10时,不同体积流速下其吸入测试的结果如表所示:2. Embodiment As shown in Figure 13, when the area ratios of the first inlet 4 and the first outlet 5 are 1:2.3 and 1:10, the results of the suction test at different volume flow rates are shown in the table:
Figure PCTCN2022142149-appb-000002
Figure PCTCN2022142149-appb-000002
Figure PCTCN2022142149-appb-000003
Figure PCTCN2022142149-appb-000003
根据实施例图13,实际测试结果可知,当第一进口4和第一出口5的面积比为1:2.3时,雾化器中药液在雾化器中和模拟人体口咽部的吸入口、锥形口和适配器中的残留较小,即雾化颗粒在雾化器和人体的口咽部残留量小。同时递送效率不受雾化药液的流速影响,即不受人体肺活量影响,进而达到极佳吸入效果;而第一进口4和第一出口5的面积比为1:10就明显比1:2.3的数据差一些。According to Figure 13 of the embodiment, the actual test results show that when the area ratio of the first inlet 4 and the first outlet 5 is 1:2.3, the liquid medicine in the nebulizer is in the nebulizer and simulates the suction port of the oropharynx of the human body. , The residue in the tapered mouth and the adapter is small, that is, the amount of atomized particles remaining in the nebulizer and the oropharynx of the human body is small. At the same time, the delivery efficiency is not affected by the flow rate of the atomized medicinal liquid, that is, it is not affected by the human lung capacity, thereby achieving an excellent inhalation effect; and the area ratio of the first inlet 4 and the first outlet 5 is 1:10, which is obviously 1:2.3 The data is slightly worse.
3.另外我们还做了一组第一进口面积与第一出口面比为1:2.3,考察第二出口7端面位置到安装环基准面的不同值的实验测试:3. In addition, we also made a group of experimental tests on the ratio of the area of the first inlet to the surface of the first outlet of 1:2.3, and investigated the different values from the position of the end face of the second outlet 7 to the reference plane of the installation ring:
Figure PCTCN2022142149-appb-000004
Figure PCTCN2022142149-appb-000004
根据上述实际测试结果可知,第二出口7端面位置到安装环基准面的距离值为4.6mm时,雾化的残留量相对15.7mm时和20.7mm时多一些;当第二出口7端面位置到安装环基准面的距离值范围在4.6mm(此时第二出口7端面与第一进口4的第二界面平齐)到20.7mm(第二出口7端面与第一出口端面平齐)时,(吸入口+锥形口+适配器)残留%递减。According to the above actual test results, it can be seen that when the distance from the end face of the second outlet 7 to the reference plane of the mounting ring is 4.6mm, the residual amount of atomization is more than that at 15.7mm and 20.7mm; when the end face of the second outlet 7 reaches When the distance value of the reference plane of the installation ring is in the range of 4.6mm (at this time, the end face of the second outlet 7 is flush with the second interface of the first inlet 4) to 20.7mm (the end face of the second outlet 7 is flush with the end face of the first outlet), (suction port + conical port + adapter) Residual % is decreasing.
最后应说明的是:以上各实施例仅用以说明本发明的技术方案,而非对其 限制;尽管参照前述各实施例对本发明进行了详细的说明,本领域的普通技术人员应当理解:其依然可以对前述各实施例所记载的技术方案进行修改,或者对其中部分或者全部技术特征进行等同替换;而这些修改或者替换,并不使相应技术方案的本质脱离本发明各实施例技术方案的范围。Finally, it should be noted that: the above embodiments are only used to illustrate the technical solutions of the present invention, rather than limiting them; although the present invention has been described in detail with reference to the foregoing embodiments, those of ordinary skill in the art should understand that: It is still possible to modify the technical solutions described in the foregoing embodiments, or perform equivalent replacements for some or all of the technical features; and these modifications or replacements do not make the essence of the corresponding technical solutions deviate from the technical solutions of the various embodiments of the present invention. scope.

Claims (25)

  1. 一种雾化器气流导引件,其特征在于,包括:An atomizer airflow guide, characterized in that it comprises:
    第一管体,所述第一管体上设有第一进口、第一出口以及连通所述第一进口、第一出口的第一导引通道;第一进口4和第一出口5的面积比为1:(1-10);The first pipe body is provided with a first inlet, a first outlet, and a first guide channel communicating with the first inlet and the first outlet; the area of the first inlet 4 and the first outlet 5 The ratio is 1: (1-10);
    第二管体,所述第二管体上设有第二进口、第二出口以及连通所述第二进口、第二出口的第二导引通道;所述第二管体的第二出口端部位于所述第一管体中。The second pipe body is provided with a second inlet, a second outlet, and a second guide channel communicating with the second inlet and the second outlet; the second outlet end of the second pipe body The part is located in the first tube body.
  2. 根据权利要求1所述的雾化器气流导引件,其特征在于,所述第一进口4和第一出口5的面积比为1:(2-5)。The airflow guide for the atomizer according to claim 1, wherein the area ratio of the first inlet 4 and the first outlet 5 is 1:(2-5).
  3. 根据权利要求1所述的雾化器气流导引件,其特征在于,第二出口端面位于第一进口的第二界面与第一出口端面之间。The airflow guide for the atomizer according to claim 1, wherein the second outlet end surface is located between the second interface of the first inlet and the first outlet end surface.
  4. 根据权利要求1所述的雾化器气流导引件,其特征在于,所述第一进口为一个或多个,设于所述第一管体的侧壁上,或者设于第一导引通道的端部且位于第一出口的相反反向,第一进口为标准的圆形、方形或其他异形,进口的角度垂直于第一管体侧壁,或者是其他各种倾斜角度;所述第一出口设于所述第一管体的端部。The airflow guide for the nebulizer according to claim 1, characterized in that, there are one or more first inlets, which are arranged on the side wall of the first pipe body, or on the first guide The end of the passage is located in the opposite direction of the first outlet, the first inlet is a standard circular, square or other special shape, and the angle of the inlet is perpendicular to the side wall of the first pipe body, or other various inclined angles; The first outlet is arranged at the end of the first pipe body.
  5. 根据权利要求1所述的雾化器气流导引件,其特征在于,所述第一进口为多个,并环绕于所述第一管体的外壁周圈,或者在第一导引通道的端部位于第一出口的相反反向。The airflow guide for the atomizer according to claim 1, wherein there are multiple first inlets, which surround the outer wall of the first pipe body, or are located in the first guide channel. The end is located on the opposite side of the first outlet.
  6. 根据权利要求1所述的雾化器气流导引件,其特征在于,所述第二进口处设有第一安装部,所述安装部适于安装药瓶;所述第二出口处设有第二安装部,所述第二安装部适于安装雾化模块。The airflow guide for the atomizer according to claim 1, wherein a first installation part is provided at the second inlet, and the installation part is suitable for installing a medicine bottle; The second installation part is suitable for installing the atomization module.
  7. 根据权利要求6所述的雾化器气流导引件,其特征在于,所述第二进口的安装部设有螺孔,便于安装药瓶,所述第二出口设有台阶孔便于安装雾化片。The airflow guide for the nebulizer according to claim 6, wherein the mounting part of the second inlet is provided with a screw hole for easy installation of a medicine bottle, and the second outlet is provided with a stepped hole for easy installation of an atomizer piece.
  8. 根据权利要求1所述的雾化器气流导引件,其特征在于,所述第二管体为弯管,适于使所述第二进口的中心轴线与所述第二出口的中心轴线之间的角度为90°-150°。The airflow guide for the nebulizer according to claim 1, wherein the second pipe body is an elbow, which is suitable for making the center axis of the second inlet and the center axis of the second outlet The angle between them is 90°-150°.
  9. 一种雾化器,其特征在于,包括权利要求1-8中任一项所述的雾化器气 流导引件。An atomizer, characterized in that it comprises the atomizer airflow guide according to any one of claims 1-8.
  10. 根据权利要求9所述的雾化器,其特征在于,还包括:The atomizer according to claim 9, further comprising:
    壳体,所述壳体可拆卸连接于所述气流导引件外侧;a casing, the casing is detachably connected to the outside of the airflow guide;
    雾化模块,包括雾化片,所述雾化片安装于所述第二出口处,适于与药液接触并震动雾化药液。The atomization module includes an atomization sheet installed at the second outlet, and is suitable for contacting the liquid medicine and vibrating to atomize the liquid medicine.
  11. 根据权利要求10所述的雾化器,其特征在于,还包括第一垫圈、第二垫圈和喷嘴压板,所述第一垫圈、第二垫圈和喷嘴压板从内到外依次安装于所述第二出口处;所述雾化片夹持在所述第一垫圈和所述第二垫圈之间。The atomizer according to claim 10, further comprising a first gasket, a second gasket and a nozzle pressure plate, the first gasket, the second gasket and the nozzle pressure plate are sequentially installed on the first gasket from inside to outside. Two outlets: the atomizing sheet is clamped between the first gasket and the second gasket.
  12. 一种喷雾组件,包括喷雾剂和权利要求9所述的雾化器,所述喷雾剂中的活性成分为β2受体激动剂、糖皮质激素、毒蕈碱受体拮抗剂和磷酸二酯酶4抑制剂中的至少一种。A spray assembly, comprising spray and the atomizer according to claim 9, the active ingredients in the spray are β2 receptor agonist, glucocorticoid, muscarinic receptor antagonist and phosphodiesterase At least one of the 4 inhibitors.
  13. 根据权利要求12所述的喷雾组件,所述β2受体激动剂包括沙丁胺醇或其药学可接受的盐、非诺特罗或其药学可接受的盐、特布他林或其药学可接受的盐、福莫特罗或其药学可接受的盐、奥达特罗或其药学可接受的盐、阿福特罗或其药学可接受的盐、茚达特罗或其药学可接受的盐、维兰特罗或其药学可接受的盐中的至少之一。The spray assembly according to claim 12, the β2 receptor agonist comprises albuterol or a pharmaceutically acceptable salt thereof, fenoterol or a pharmaceutically acceptable salt thereof, terbutaline or a pharmaceutically acceptable salt thereof , formoterol or a pharmaceutically acceptable salt thereof, olodaterol or a pharmaceutically acceptable salt thereof, arformoterol or a pharmaceutically acceptable salt thereof, indacaterol or a pharmaceutically acceptable salt thereof, vilan At least one of terol or a pharmaceutically acceptable salt thereof.
  14. 根据权利要求12所述的喷雾组件,所述糖皮质激素包括氟替卡松或其药学可接受的盐或酯、莫米松或其药学可接受的盐或酯、环索奈德或其药学可接受的盐或酯、倍氯米松或其药学可接受的盐或酯、氟尼缩松或其药学可接受的盐或酯、布地奈德或其药学可接受的盐或酯、曲安奈德或其药学可接受的盐或酯、地塞米松或其药学可接受的盐或酯中的至少之一。The spray assembly according to claim 12, the glucocorticoids include fluticasone or a pharmaceutically acceptable salt or ester thereof, mometasone or a pharmaceutically acceptable salt or ester thereof, ciclesonide or a pharmaceutically acceptable salt thereof or ester, beclomethasone or its pharmaceutically acceptable salt or ester, flunisolide or its pharmaceutically acceptable salt or ester, budesonide or its pharmaceutically acceptable salt or ester, triamcinolone acetonide or its pharmaceutically acceptable salt or ester At least one of acceptable salts or esters, dexamethasone or pharmaceutically acceptable salts or esters thereof.
  15. 根据权利要求12所述的喷雾组件,所述毒蕈碱受体拮抗剂包括噻托铵或其药学可接受的盐、格隆铵或其药学可接受的盐、乌美铵或其药学可接受的盐、芜地铵或其药学可接受的盐、异丙托铵或其药学可接受的盐、氧托铵或 其药学可接受的盐、revefenacin或其药学可接受的盐中的至少之一。The spray assembly according to claim 12, said muscarinic receptor antagonist comprises tiotropium or a pharmaceutically acceptable salt thereof, glycopyrronium or a pharmaceutically acceptable salt thereof, umeclidinium or a pharmaceutically acceptable salt thereof At least one of the salt of umeclidinium or a pharmaceutically acceptable salt thereof, ipratropium or a pharmaceutically acceptable salt thereof, oxygentropium or a pharmaceutically acceptable salt thereof, revefenacin or a pharmaceutically acceptable salt thereof .
  16. 根据权利要求12所述的喷雾组件,所述磷酸二酯酶4抑制剂包括罗氟司特或其药学可接受的衍生物、阿普斯特或其药学可接受的衍生物中的至少之一。The spray assembly according to claim 12, said phosphodiesterase 4 inhibitor comprising at least one of roflumilast or a pharmaceutically acceptable derivative thereof, apremilast or a pharmaceutically acceptable derivative thereof .
  17. 一种权利要求12-16任一所述的喷雾组件在制备用于治疗COPD和/或哮喘药物中的用途。A use of the spray assembly described in any one of claims 12-16 in the preparation of a medicament for treating COPD and/or asthma.
  18. 一种喷雾组件,包括喷雾剂和权利要求9所述的雾化器,所述喷雾剂中的活性成分包括前列环素、曲罗尼尔、伊洛前列素中的至少一种。A spray assembly, comprising a spray and the atomizer according to claim 9, wherein the active ingredient in the spray comprises at least one of prostacyclin, treprostinil and iloprost.
  19. 一种权利要求18所述的喷雾组件在制备用于治疗肺动脉高血压药物中的用途。A use of the spray assembly according to claim 18 in the preparation of medicines for treating pulmonary arterial hypertension.
  20. 一种喷雾组件,包括喷雾剂和权利要求9所述的雾化器,所述喷雾剂中的活性成分包括抗生素或者抗病毒药物,所述抗生素包括氨曲南、妥布霉素、阿米卡星、环丙沙星中的至少一种,所述抗病毒药物包括扎那米韦、Laninamivir、利巴韦林的至少一种。A spray assembly, comprising a spray and the atomizer according to claim 9, the active ingredients in the spray include antibiotics or antiviral drugs, and the antibiotics include aztreonam, tobramycin, amika At least one of star and ciprofloxacin, and the antiviral drug includes at least one of zanamivir, laninamivir and ribavirin.
  21. 一种权利要求20所述的喷雾组件在制备用于治疗肺部感染药物中的用途。A use of the spray assembly according to claim 20 in preparing medicine for treating pulmonary infection.
  22. 一种喷雾组件,包括喷雾剂和权利要求9所述的雾化器,所述喷雾剂中的活性成分包括吡非尼酮、尼达尼布中的至少一种。A spray assembly, comprising a spray and the atomizer according to claim 9, the active ingredient in the spray comprises at least one of pirfenidone and nintedanib.
  23. 一种权利要求22所述的喷雾组件在制备用于治疗特发性肺纤维化药物中的用途。A use of the spray assembly according to claim 22 in the preparation of medicines for treating idiopathic pulmonary fibrosis.
  24. 一种喷雾组件,包括喷雾剂和权利要求9所述的雾化器,所述喷雾剂中的活性成分小分子类细胞毒性药物或者生物制剂。A spray assembly, comprising a spray and the nebulizer according to claim 9, the active ingredient in the spray is a small molecule cytotoxic drug or a biological agent.
  25. 一种权利要求24所述的喷雾组件在制备用于治疗肺癌药物中的用途。A use of the spray assembly according to claim 24 in the preparation of medicines for treating lung cancer.
PCT/CN2022/142149 2021-12-28 2022-12-27 Nebulizer and gasflow guide member thereof WO2023125471A1 (en)

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CN103041480A (en) * 2011-10-12 2013-04-17 泰博科技股份有限公司 Atomization device and nozzle thereof
CN105597200A (en) * 2016-02-04 2016-05-25 深圳金亿帝医疗设备股份有限公司 Atomizing cup suite and compressed atomizer
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