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WO2022199379A1 - Dispositif de pulvérisation pour administration nasale et système d'administration - Google Patents

Dispositif de pulvérisation pour administration nasale et système d'administration Download PDF

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Publication number
WO2022199379A1
WO2022199379A1 PCT/CN2022/079836 CN2022079836W WO2022199379A1 WO 2022199379 A1 WO2022199379 A1 WO 2022199379A1 CN 2022079836 W CN2022079836 W CN 2022079836W WO 2022199379 A1 WO2022199379 A1 WO 2022199379A1
Authority
WO
WIPO (PCT)
Prior art keywords
liquid storage
cup
spray device
cup cover
nasal administration
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/CN2022/079836
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English (en)
Chinese (zh)
Inventor
张晓芳
宋保组
储成生
谢勇
逄永刚
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Hefei Breath Medical Co Ltd
Original Assignee
Hefei Breath Medical Co Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from CN202120587738.8U external-priority patent/CN214911992U/zh
Priority claimed from CN202110314650.3A external-priority patent/CN112957572A/zh
Application filed by Hefei Breath Medical Co Ltd filed Critical Hefei Breath Medical Co Ltd
Publication of WO2022199379A1 publication Critical patent/WO2022199379A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M11/00—Sprayers or atomisers specially adapted for therapeutic purposes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M11/00—Sprayers or atomisers specially adapted for therapeutic purposes
    • A61M11/02—Sprayers or atomisers specially adapted for therapeutic purposes operated by air or other gas pressure applied to the liquid or other product to be sprayed or atomised
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M15/00—Inhalators
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M31/00—Devices for introducing or retaining media, e.g. remedies, in cavities of the body

Definitions

  • the invention relates to the field of atomizers, in particular to a spray device and a drug delivery system for nasal administration.
  • the commonly used nasal drop particles are 50-100 microns. After the nasal particles are injected into the nasal cavity, they will be effectively filtered by the nasal valve. Therefore, the drugs and saline in the form of aerosols only stay in the front 10 cm of the nasal cavity. It will reach the location of the posterior nasal cavity and sinuses.
  • the advantage of the existing nasal/lung nebulizer is that it can provide aerosols of small particles smaller than 5 microns, increasing the amount of drug deposited in the nasal valve.
  • the small airway between the maxillary sinus and the nasal cavity, with a diameter of only less than 5 mm restricts the entry of aerosols into the maxillary sinus.
  • in vitro and in vivo studies have shown that the amount of aerosol entering the nasal cavity through a nasal nebulizer is approximately 33- 58% entered the lungs, increasing the risk of side effects, with potential pulmonary toxic effects.
  • Chinese invention patent publication number CN103917265B discloses a compound delivery device for delivering plumes derived from propellants and pharmaceutical preparations.
  • the pharmaceutical preparations are presented in intranasal dosage forms as powders, suspensions, dispersions or liquids.
  • the propelled intranasal dosage form is deposited in the olfactory zone of the nasal cavity. Drugs deposited in the olfactory zone are delivered to the brain, thereby avoiding the blood-brain barrier.
  • the hydrofluoroalkane propellant from the pressurized canister is directed to the diffuser and medicated chamber where the intranasal dosage form is aerosolized.
  • the aerosolized intranasal dosage form is passed through the nozzle, delivering the plume to the olfactory area of the user's nasal cavity.
  • each nebulizer currently has its own problems, and there is no nebulizer for nasal administration, which can accurately deliver the drug to the posterior nasal cavity and sinuses (such as ethmoid sinus, frontal sinus, upper jaw) It is localized and does not deliver the drug to the lungs with the breath.
  • sinuses such as ethmoid sinus, frontal sinus, upper jaw
  • the present invention provides a spray device for nasal administration.
  • a spray device for nasal administration By designing an air outlet hole, an air flow channel part, an atomizing nozzle and a conveying part between the outer surface of the air flow channel part and the inner surface of the fluid channel part with reasonable dimensions, the It is beneficial to control the size and size distribution of the aerosolized drug particles of the spray device for nasal administration, and at the same time, the size of the drug gas flow and air pressure of the spray device for nasal administration is controlled by the control system to maintain the set value, and the drug is sprayed.
  • the agent is accurately delivered to the lesions in the nasal cavity and sub-nasal cavity through the bidirectional airflow cannula and acts directly on the sinuses, providing continuous treatment for the narrowed parts of the sinuses.
  • the spray device for nasal administration of the present invention includes a liquid storage cup for storing the medicinal spray, and the liquid storage cup includes an air outlet and an air flow channel part communicated with the air outlet, The diameter of the air outlet is 0.35mm-2.5mm, and the height of the air flow channel is 0.7-6.0mm;
  • the liquid storage cup cover is adapted to the liquid storage cup, and the liquid storage cup cover includes an atomizing nozzle and a fluid channel part communicated with the atomizing nozzle, the diameter of the atomizing nozzle is 0.5 mm-3 mm;
  • the diameter of the fluid channel part is larger than the diameter of the airflow channel part, and the liquid storage cup is connected to the
  • a conveying part is formed between the outer surface of the air flow channel part and the inner surface of the fluid channel part, and the diameter of the conveying part is 0.002 mm-0.5 mm; the control system, using The size of the drug gas flow and the air pressure of the spray device for controlling the nasal drug delivery is maintained at
  • the beneficial effects of the present invention are that: the diameter of the air outlet is between 0.35 mm and 2.5 mm, the height of the airflow channel is between 0.7 mm and 6.0 mm, and the diameter of the atomizing nozzle is between 0.5 mm and 3 mm.
  • the diameter of the conveying part is between 0.002 mm and 0.5 mm.
  • the size of the drug delivery airflow and air pressure of the spray device is maintained at the set value, and the drug spray is accurately delivered to the lesions in the nasal cavity and sub-nasal cavity through the bidirectional airflow cannula, and directly acts on the sinuses, providing continuous sinus stenosis. Treatment.
  • the liquid storage cup comprises a cylindrical base body, a discharge pipe and a bottom cup wall, and the cylindrical base body, the discharge pipe, the bottom cup wall and the airflow channel part together constitute a storage space for the medicine,
  • the discharge pipe is arranged on the side wall of the cylindrical base, and the bottom cup wall connects the airflow channel portion and the cylindrical base.
  • the bottom cup wall includes symmetrically arranged concave portions, and the concave portions are disposed on a side close to the fluid channel.
  • the beneficial effect is that the concave portion is used to collect the medicinal spray.
  • cylindrical base body, the bottom cup wall, the air flow channel portion and the discharge pipe are of an integral structure.
  • the liquid storage cup further includes a liquid storage cup cover connecting portion disposed on a side of the cylindrical base away from the bottom cup wall.
  • the beneficial effect is that: the connecting part of the liquid storage cup cover is adapted to fit the liquid storage cup cover to form a storage space for the medicine spray.
  • the liquid storage cup cover includes an ejection outer wall adapted to the cylindrical base body and a connection inner wall adapted to the connection portion of the liquid storage cup cap, the ejection outer wall, the connection inner wall, The atomizing nozzle and the fluid passage portion together constitute a gas injection chamber.
  • the liquid storage cup cover further includes a fixing portion, and the fixing portion is disposed at the central axis of the liquid storage cup cover to detachably connect the liquid storage cup and the liquid storage cup cover.
  • the liquid storage cup cover further includes a gas controller adapted to the atomizing nozzle, the gas controller is disposed on the side of the atomizing nozzle away from the fluid channel portion, and is connected to the The ejection chamber is connected to the outer wall.
  • the beneficial effect is that the gas controller forms a barrier at the bottom end of the spray chamber to control the gas flow rate.
  • At least one built-in groove is provided inside the fluid channel portion.
  • the beneficial effect is that: the built-in groove, the outer wall of the fluid channel part and the inner wall of the fluid channel part form a narrow liquid suction channel that communicates with the concave part, and drains the medicine spray collected by the concave part. to the atomizing nozzle.
  • the liquid storage cup further includes a storage part, a liquid cup base and a support part, the liquid cup base is connected with the bottom of the storage part to form a storage space for the medicinal spray, and the support part is connected to the bottom of the storage part.
  • the liquid cup holder is connected and arranged on the side of the liquid cup holder away from the air outlet.
  • the liquid storage cup includes a cylindrical tube that communicates with the air flow channel portion, the cylindrical tube is adapted to the liquid cup holder, and is disposed on the inner side of the storage portion.
  • the cylindrical pipe further includes an air inlet insertion port, and the air inlet insertion port is arranged in communication with the air flow channel part.
  • the air inlet insertion port is used to provide the gas for atomizing the drug spray, so that the gas enters the air flow passage part, and passes through the air outlet to form an air flow.
  • the liquid storage cup further includes at least one horizontal mark or at least one reticle to indicate the liquid level.
  • the liquid storage cup cover includes an expansion cup cover, a cup cover, and a cup cover base, and the expansion cup cover is arranged between the fluid channel portion and the cup cover, and is arranged along the liquid storage cup cover. Protruding away from the axial direction to fit the storage part, the cup cover is arranged between the expansion cover and the cover base to fit the cylindrical tube, and the cover base is arranged on the A side of the cup cover away from the expansion cup cover is matched with the liquid storage cup.
  • the beneficial effect is that: the expansion cup cover is matched with the storage part to prevent liquid from overflowing from the liquid storage cup, and the cup cover and the cylindrical tube are matched to form the outer surface of the airflow channel part. A delivery portion between the surface and the inner surface of the fluid channel portion to store the medicament spray to be atomized.
  • the cup cover base further includes at least one cup cover groove to form a liquid circulation channel between the liquid storage cup and the cup cover base.
  • the cup cover groove is used to allow the medicine spray from the liquid storage cup to flow into the delivery part between the outer surface of the airflow channel part and the inner surface of the fluid channel part middle.
  • the fluid channel portion further includes a return portion disposed on the outer side surface of the fluid channel portion, the return portion includes an extension groove and a vertical groove, and the vertical groove extends from the atomizing nozzle.
  • the outer side edge of the cup extends to the cup cover, and the extending groove is connected with the end of the vertical groove on the side of the cup cover, and is perpendicular to the outer side surface of the fluid channel portion.
  • the return portion further includes at least one return hole to communicate the outside of the liquid storage cup cover with the inner cavity of the liquid storage cup.
  • the beneficial effect is that: the return hole presses the dropped medicine spray back to the storage part through the difference of internal and external air pressure, thereby minimizing the waste of the medicine spray.
  • control system includes a nasal spray pump connected to the air flow channel portion for providing air flow to the nasal spray device.
  • control system further includes a main control part, which is communicatively connected to the nasal spray pump to control the air flow and air pressure.
  • the main control part includes a driving module, a monitoring module and a timing module that are communicatively connected to the main control part, the driving module is used to provide driving force to the nasal spray pump, and the monitoring module is used to provide driving force to the nasal spray pump.
  • the timing module is used to record the rising time, the holding time, the falling time and the spray delay time of the driving force applied by the driving module.
  • the bidirectional airflow cannula includes an aerogel delivery tube and a pressurized air delivery tube, the aerogel delivery tube is used to deliver the drug spray to the lesion site of the first nasal cavity, and the pressurized air The delivery tube is used to close the nasal breathing system by delivering pressurized air into the second nasal cavity.
  • the beneficial effect is that the bidirectional airflow cannula is used to close the nasal breathing system during treatment, so as to continuously inject the aerosolized medicine into the nasal cavity.
  • the aerogel delivery tube includes an aerogel outlet, an aerogel hose interface and an outer wall of the connection of the aerogel cannula, and the aerogel outlet and the aerogel hose interface are arranged at the same location.
  • Both ends of the aerogel delivery tube, the outer wall of the aerogel intubation tube connection is adapted to the discharge tube, and the aerogel outlet is arranged on the aerogel delivery tube away from the aerogel insertion tube.
  • the pressurized air delivery pipe includes a pressurized air outlet and a pressurized air insertion port, and the pressurized air outlet and the pressurized air insertion port are provided at both ends of the pressurized air delivery pipe,
  • the pressurized air outlet is provided on a side close to the aerogel outlet.
  • the present invention also provides a drug delivery system, comprising the spray device for nasal drug delivery.
  • Embodiment 1 is a front view of the liquid storage cup described in Embodiment 1 of the present invention.
  • Fig. 2 is the front view of the liquid storage cup cover described in the first embodiment of the present invention
  • Example 3 is a schematic diagram of the spray device for nasal administration described in Example 1 of the present invention.
  • FIG. 4 is a frame diagram of the main control unit described in Embodiment 1 of the present invention.
  • FIG. 5 is a schematic diagram of the bidirectional airflow cannula described in Embodiment 1 of the present invention.
  • FIG. 6 is a top view of the bidirectional airflow cannula described in Embodiment 1 of the present invention.
  • FIG. 7 is a cross-sectional view of the bidirectional airflow cannula described in Embodiment 1 of the present invention.
  • FIG. 8 is a front view of the bidirectional airflow cannula according to the first embodiment of the present invention.
  • Fig. 9 is the front view of the liquid storage cup in the second embodiment of the present invention.
  • Embodiment 10 is a schematic structural diagram of a liquid storage cup in Embodiment 2 of the present invention.
  • Fig. 11 is the front view of the liquid storage cup cover in the second embodiment of the present invention.
  • FIG. 12 is a schematic structural diagram of a liquid storage cup cover in Embodiment 2 of the present invention.
  • FIG. 13 is a sectional view of the structure formed after the liquid storage cup cover is inserted into the liquid storage cup in the second embodiment of the present invention.
  • FIG 14 is a top view of the structure formed after the liquid storage cup cover is inserted into the liquid storage cup in the second embodiment of the present invention.
  • 1-liquid storage cup 11-air outlet; 12-air flow channel part; 13-storage part; 14-liquid cup seat; 15-support part; 16-cylindrical pipe; 17-air inlet insertion port; 18-cylindrical Base body; 181-connecting part of liquid storage cup lid; 19-discharge pipe; 10-bottom cup wall; 101-recessed part;
  • 2-Lid of liquid storage cup 21-Atomization nozzle; 211-Gas controller; 22-Fluid channel part; 221-Built-in groove; 23-Extended cup cover; 24-Cup cover; Cup lid groove; 27-return part; 271-extending groove; 272-vertical groove; 28-spraying outer wall; 29-connecting inner wall; 20-fixing part;
  • 5- bidirectional airflow cannula 51- aerogel delivery tube; 511- aerogel outlet; 512- aerogel hose interface; 513- aerogel cannula connection outer wall; 52- pressurized air delivery tube; 521-pressurized air outlet; 522-pressurized air insertion port.
  • Embodiment 1 of the present invention provides a spray device for nasal administration.
  • FIG. 1 is a front view of the liquid storage cup described in Embodiment 1 of the present invention
  • FIG. 2 is an embodiment of the present invention.
  • Figure 3 is a schematic diagram of the spray device for nasal administration according to the first embodiment of the present invention
  • Figure 4 is the frame of the main control part described in the first embodiment of the present invention.
  • FIG. 5 is a schematic diagram of the bidirectional airflow cannula described in Embodiment 1 of the present invention.
  • the spray device for nasal administration includes: a liquid storage cup 1 for storing medicinal sprays, and the storage
  • the liquid cup 1 includes an air outlet hole 11 and a conical air flow channel portion 12 communicating with the air outlet hole 11.
  • the diameter of the air outlet hole 11 is between 0.35 mm and 2.5 mm, and the height of the air flow channel portion 12 is Between 0.7-6.0 mm;
  • the liquid storage cup cover 2 is adapted to the liquid storage cup 1, and the liquid storage cup cover 2 includes an atomizing nozzle 21 and a fluid channel portion 22 that communicates with the atomizing nozzle 21.
  • the diameter of the atomizing nozzle 21 is between 0.5 mm and 3 mm; the diameter of the fluid channel portion 22 is larger than the diameter of the airflow channel portion 12 , the liquid storage cup 1 and the liquid storage cup cover 2 After fitting, there is a conveying part 3 between the outer surface of the airflow channel part 12 and the inner surface of the fluid channel part 22 , and the diameter of the conveying part 3 is between 0.002 mm and 0.5 mm.
  • the diameter of the air outlet 11, the diameter of the atomizing nozzle 21 and the The size of the conveying portion 3 is limited, and the size of the conveying portion 3 is the fitting gap between the liquid storage cup and the liquid storage cup cover.
  • 15 different sizes of spray devices for nasal administration were tested by injection molding/3D printing by inputting different pressures, including air of 50kPa, 70kPa, 100kPa, 150kPa, 200kPa and 250kPa.
  • the particle size distribution of the aerosols produced under gas pressure, and the volume mean diameter (VMD) and particle size distribution ratio were calculated by a laser diffraction method spray particle size analysis system (Malvern, Spraytec).
  • the combined sequences in Table 2 represent the codes for the different nasally administered spray devices.
  • the atomized particle analysis results of the above 15 design schemes under the pressure of 250KPa are shown in Table 3.
  • the first ratio in Table 3 is the ratio of the diameter of the atomizing nozzle 12 to the air outlet hole 11
  • the second ratio is the ratio of the size of the conveying part 3 to the diameter of the air outlet hole 11
  • the conveying The size of the part 3 is the fitting clearance between the liquid storage cup and the liquid storage cup cover.
  • Table 3 records the size of D10, D50, D90 and RS that each nasally administered spray device responds to under a pressure of 250KPa, to evaluate the diameter of the air outlet 11, the size of the atomizing nozzle 21 The empirical relationship between the diameter, the diameter size of the delivery part 3 and the gas pressure input from the main control part to the spray particle size of the spray device for nasal administration.
  • Table 4 shows the influence parameters of the three influence factors calculated by the design software (DOE), and the optimal atomized particle analysis of the three groups of optimal nozzle design parameters under the pressure of 250KPa.
  • DOE design software
  • the optimal design parameters are generated through the analysis of the design software, including generating the nasal administration of 15-40 micron aerosols.
  • the diameter of the air outlet of the preferred nasal administration spray device is 0.8015 mm
  • the diameter of the atomizing nozzle is 1.27 mm
  • the diameter of the delivery part is 0.8015 mm.
  • the width is 0.0518 mm.
  • the diameter of the air outlet of the preferred spray device for nasal administration is 0.7 mm
  • the diameter of the atomizing nozzle is 1.15 mm
  • the diameter of the delivery part is 0.7 mm.
  • the width is 0.05mm.
  • the diameter of the air outlet of the preferred nasal administration spray device is 0.78 mm
  • the diameter of the atomizing nozzle is 1.16 mm
  • the delivery portion The width is 0.025 mm.
  • the liquid storage cup 1 includes a cylindrical base 18 , a discharge pipe 19 and a bottom cup wall 10 .
  • the cylindrical base 18 , the discharge pipe 19 , the The bottom cup wall 10 and the airflow channel portion 12 together constitute a storage space for the medicine, the discharge pipe 19 is arranged on the side wall of the cylindrical base 18, and the bottom cup wall 10 is connected to the airflow channel portion. 12 and the cylindrical base 18 .
  • the bottom cup wall 10 includes symmetrically arranged concave portions 101 , and the concave portions 101 are disposed on a side close to the airflow channel portion 12 to collect the medicinal spray.
  • the cylindrical base body 18 , the bottom cup wall 10 , the airflow channel portion 12 and the discharge pipe 19 are integral structures.
  • the liquid storage cup 1 further includes a liquid storage cup cover connecting portion 181 , which is disposed on the side of the cylindrical base 18 away from the bottom cup wall 10 .
  • the cup cover connecting portion 181 is used to fit the liquid storage cup cover 2 to form a storage space for the medicinal spray.
  • the liquid storage cup cover 2 includes a spraying chamber wall 28 adapted to the cylindrical base 18 and a connecting part with the liquid storage cup cover 181 is adapted to the connecting inner wall 29, the spraying outer wall 28, the connecting inner wall 29, the atomizing nozzle 21 and the fluid channel part 22 together constitute a gas spraying chamber.
  • the liquid storage cup cover 2 further includes a fixing portion 20 , and the fixed portion 20 is disposed at the central axis of the liquid storage cup cover 2 to detachably connect the The liquid storage cup 1 and the liquid storage cup cover 2.
  • the liquid storage cup cover 2 further includes a gas controller 211 adapted to the atomizing nozzle 21 , and the gas controller 211 is disposed at the atomizing nozzle 21 away from the One side of the fluid channel part 22 is connected to the outer wall 28 of the injection chamber, and the gas controller 211 forms a block at the bottom end of the injection chamber to control the gas flow rate.
  • At least one built-in groove 221 is provided inside the fluid channel portion 22 , and the built-in groove 221 is connected to the outer wall of the fluid channel portion 22 and the fluid channel portion 22 .
  • the inner wall of the cavity forms a narrow liquid suction channel that communicates with the concave portion 101 , and drains the medicinal spray collected by the concave portion 101 to the atomizing nozzle 21 .
  • control system includes a nasal spray pump (not shown in the figure), which is connected to the airflow channel portion 12 and is used to deliver the spray to the nasal cavity.
  • the device provides airflow.
  • control system further includes a main control part 4, which is communicatively connected to the nasal spray pump (not shown in the figure) to control the air flow and air pressure.
  • the main control part 4 includes a driving module 41 , a monitoring module 42 and a timing module 43 communicatively connected to the main control part 4 , the driving module 41 Used to provide driving force to the nasal spray pump (not shown in the figure), the monitoring module 42 is used to monitor and record the size of the driving force in real time, and the timing module 43 is used to record the driving module 41 Rise time, hold time, fall time and spray delay time of applied driving force.
  • the monitoring module 42 monitors and records the magnitude of the driving force in real time, and sends the recording result to the main control part 4 , and the main control part 4 controls the driving module 41 to make the driving force is maintained at the set value to obtain stable dosing airflow and air pressure.
  • the range of the driving force setting value is 50-250KPa, which is adjusted according to the treatment effect of the lesion in the nasal cavity.
  • control system controls the size of the supply air flow and air pressure by setting the driving force, the rising time, the holding time and the falling time of the driving force, the rising time, the holding time and the falling time of the driving force.
  • the descent time was adjusted according to the treatment of each nasal lesion.
  • the driving force of the driving module 41 is set to be 4.5kg
  • the driving force of the timing module 43 is set to rise time of 0.3s, hold time to be 2.0s, fall time to be 65s, and spray delay time to be 1s
  • the main control part 4 controls the nasal spray pump (not shown in the figure) to provide air flow and air pressure according to the set parameters, and measures the size distribution of droplets ejected by the spray device for nasal administration.
  • the size distribution of the atomized particles of the spray devices for nasal administration of 3 groups of different sizes was tested, as shown in Table 5.
  • the D10 of NNXS06, 13 and 15 are 4.7, 16.1 and 11.3 microns, respectively, while the D90 of the atomized particles obtained by the three nozzle structures are 42.7, 65.2 and 89 microns, respectively.
  • the atomized particle distribution of NNXS06 is narrow and 90% The particles are between 5-43 microns, which is closest to the design goal of the present invention and is the preferred condition of the present invention.
  • the bidirectional airflow cannula 5 includes an aerogel delivery tube 51 and a pressurized air delivery tube 52 , and the aerogel delivery tube 51 is used for The drug spray is delivered to the lesion in the first nasal cavity, and the pressurized air delivery tube 52 is used to deliver pressurized air into the second nasal cavity to close the nasal respiratory system.
  • the bidirectional airflow cannula 5 is used to close the nasal breathing system during treatment, so as to continuously inject the aerosolized medicine into the nasal cavity.
  • the aerogel delivery tube 51 described in conjunction with FIG. 3 , FIG. 5 and FIG. 6 includes an aerogel outlet 511 , an aerogel hose interface 512 and an outer wall 513 at the connection of the aerogel intubation, the aerogel outlet 511 and the aerogel hose interfaces 512 are provided at both ends of the aerogel delivery tube 51, the outer wall 513 of the aerogel intubation connection is adapted to the discharge tube 19, and can be disassembled or connected by rotating , the aerogel outlet 511 is disposed on the side of the aerogel delivery tube 51 away from the outer wall 513 of the aerogel cannula connection.
  • the pressurized air delivery pipe 52 includes a pressurized air outlet 521 and a pressurized air insertion port 522 , and the pressurized air outlet 521 and the pressurized air insertion port 522 are provided At both ends of the pressurized air delivery pipe 52 , the pressurized air outlet 521 is provided on a side close to the aerogel outlet 511 .
  • the liquid storage cup 1 further includes at least one horizontal mark or at least one marking line (not shown in the figure) to indicate a specific liquid level.
  • FIG. 9 is a front view of the liquid storage cup in the second embodiment of the present invention
  • FIG. 10 is the second embodiment of the present invention
  • Figure 11 is a front view of the liquid storage cup lid in the second embodiment of the present invention
  • Figure 12 is a schematic structural diagram of the liquid storage cup lid in the second embodiment of the present invention
  • Figure 13 is the Figure 14 is a top view of the structure formed after the liquid storage cup cover is inserted into the liquid storage cup in the second embodiment of the present invention.
  • the spray device for nasal administration includes: a liquid storage cup 1 for storing medicinal sprays, and the liquid storage cup 1 includes an air outlet 11 and a The conical airflow channel part 12 communicated with the air outlet hole 11, the diameter of the air outlet hole 11 is between 0.35 mm and 2.5 mm, and the height of the air flow channel part 12 is between 0.7 mm and 6.0 mm; the liquid storage cup
  • the cover 2 is adapted to the liquid storage cup 1.
  • the liquid storage cup cover 2 includes an atomizing nozzle 21 and a fluid channel portion 22 communicating with the atomizing nozzle 21.
  • the diameter of the atomizing nozzle 21 is between 0.5 mm and 3 mm; the diameter of the fluid channel portion 22 is larger than the diameter of the air flow channel portion 12 , after the liquid storage cup 1 is fitted with the liquid storage cup cover 2 , the airflow channel portion 12 There is a conveying part 3 between the outer surface of the fluid channel part 22 and the inner surface of the fluid channel part 22 , and the diameter of the conveying part 3 is between 0.002 mm and 0.5 mm.
  • the liquid storage cup 1 further includes a storage part 13 , a liquid cup base 14 and a support part 15 , the liquid cup base 14 and the bottom of the storage part 13 .
  • the support part 15 is connected with the liquid cup holder 14 and is arranged on the side of the liquid cup holder 14 away from the air outlet 11 to allow the nasal cavity to give
  • the medicated spray device is erected on the upper horizontal surface of the host to which the nasally administered spray device is connected.
  • the liquid storage cup 1 includes a cylindrical tube 16 , which is communicated with the airflow channel portion 12 , is connected to and fits with the liquid cup holder 14 , and is disposed inside the storage portion 13 .
  • the cylindrical tube 16 is disposed at the lower end of the airflow channel part 12 , the liquid cup holder 14 is circular, and the number of the support parts 15 is Even numbers are used to support the liquid cup holder 14 .
  • the cylindrical pipe 16 further includes an air inlet insertion port 17 , the air inlet insertion port 17 is arranged in communication with the air flow passage portion 12 , and the air inlet insertion port 17 is used for
  • the gas enters the air flow channel part 12, and the air flow is formed after passing through the air outlet 11, and the air inlet insertion port 17 is used to connect the spray for administration to the nasal cavity.
  • the docking port of the air compressor that provides the gas in the device allows the device to continuously supply pressurized air to the nebulizer for nasal administration.
  • the liquid storage cup 1 further includes at least one horizontal mark or at least one marking line (not shown in the figure) to indicate a specific liquid level.
  • the liquid storage cup cover 2 includes an extension cup cover 23 , a cup cover 24 , and a cup cover base 25 ;
  • the extension cup cover 23 is provided on the Between the fluid channel part 22 and the cup cover 24, and protruding outward along the outer direction of the liquid storage cup cover 2, to fit the storage part 13 to prevent the liquid from overflowing from the liquid storage cup 1
  • the cup cover 24 is arranged between the extended cup cover 23 and the cup cover base 25 to fit the cylindrical tube 16;
  • the cup cover base 25 is arranged on the cup cover 24 away from the One side of the expansion cup cover 23 is adapted to the liquid storage cup 1
  • the cup cover 24 and the cylindrical tube 16 are adapted to form the outer surface of the airflow channel part 12 and the fluid channel part 22 between the inner surfaces of the delivery portion to store the drug spray to be atomized.
  • the cup cover base 25 further includes at least one cup cover groove 26 to connect the cup cover base 25 of the liquid storage cup 1 and the liquid storage cup cover 2 A liquid circulation channel is formed therebetween, and the cup cover groove 26 is used to allow the medicinal spray to flow from the liquid storage cup 1 to the outer surface of the airflow channel part 12 and the inner surface of the fluid channel part 22 in the conveying section between the surfaces.
  • the fluid channel portion 22 further includes a return portion 27 disposed on the outer side of the fluid channel portion 22 , and the return portion 27 includes an extension groove 271 and a vertical groove 272, the vertical groove 272 extends from the outer edge of the atomizing nozzle 21 to the cup cover 24, and the extending groove 271 is perpendicular to the side of the cup cover 24.
  • the ends of the grooves 272 are connected and are perpendicular to the outer surface of the fluid channel portion 22 , and the return portion 27 is used for draining the dropped medicine spray.
  • the extending groove 271 of the return portion 27 is further provided with at least one return hole (not shown in the figure), so as to connect the outside of the liquid storage cup cover 2 with all The inner cavity of the liquid storage cup 1 is communicated, and the return hole presses the dropped medicinal spray back to the storage part 13 through the difference of internal and external air pressure, thereby minimizing the waste of medicinal spray.
  • the spray device for nasal administration further includes a control system, and the control system includes a nasal spray pump (not shown in the drawings), which is connected to the airflow channel portion 12 , to provide airflow to the nasally administered spray device.
  • a nasal spray pump (not shown in the drawings), which is connected to the airflow channel portion 12 , to provide airflow to the nasally administered spray device.
  • the driving module 41 is used to provide driving force to the nasal spray pump (not shown in the figure), and the monitoring module 42 is used to monitor and record the driving force in real time.
  • the timing module 43 is used to record the rising time, holding time, falling time and spray delay time of the driving force applied by the driving module 41 .
  • the control system of the second embodiment of the present invention further includes a main control unit 4 , which is the same as the main control unit 4 of the control system of the first embodiment of the present invention.
  • the structure and function are the same, and all include a drive module 41, a monitoring module 42 and a timing module 43 that are communicatively connected to the main control unit 4, and the drive module 41 is used to spray the nasal spray pump (not shown in the figure).
  • the monitoring module 42 is used to monitor and record the size of the driving force in real time
  • the timing module 43 is used to record the rise time, hold time, fall time and Spray delay time.
  • the main control part 4 is communicatively connected to a nasal spray pump (not shown in the figure), and the nasal spray pump is connected to the airflow channel part 12 for sending the The nasally-administered spray device provides airflow.
  • the monitoring module 42 monitors and records the magnitude of the driving force in real time, and sends the recording result to the main control part 4 , and the main control part 4 controls the driving module 41 by controlling the driving force.
  • the magnitude of the driving force is maintained at the set value to obtain stable drug gas flow and air pressure. It should be noted that the range of the driving force setting value is 50-250KPa, which is adjusted according to the treatment effect of the lesion in the nasal cavity.
  • control system controls the size of the supply air flow and air pressure by setting the driving force, the rising time, the holding time and the falling time of the driving force, the rising time, the holding time and the falling time of the driving force.
  • the descent time was adjusted according to the treatment of each nasal lesion.
  • the present invention also provides a drug delivery system, including the spray device for nasal administration according to any one of Embodiment 1 and Embodiment 2.

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Pulmonology (AREA)
  • Medicinal Preparation (AREA)

Abstract

La présente invention concerne un dispositif de pulvérisation pour administration nasale, le dispositif comprenant : une coupelle de stockage de liquide, qui comprend un évent ayant un diamètre allant de 0,35 mm à 2,5 mm, et une partie canal d'écoulement d'air ayant une hauteur allant de 0,7 mm à 6,0 mm et en communication avec l'évent ; un couvercle de coupelle de stockage de liquide qui s'adapte au couvercle de stockage de liquide et qui comprend une buse d'atomisation ayant un diamètre allant de 0,5 mm à 3 mm et une partie canal de fluide en communication avec la buse d'atomisation. Une fois que la coupelle de stockage de liquide est montée sur le couvercle de coupelle de stockage de liquide, une partie de transport ayant un diamètre allant de 0,002 mm à 0,5 mm est ménagée entre une surface extérieure de la partie canal de flux d'air et une surface intérieure de la partie canal de fluide ; une partie commande principale servant à commander les amplitudes de flux d'air d'administration de médicament et de pression d'air ; et une canule de flux d'air à deux voies pour transporter une pulvérisation de médicament. Selon le dispositif de pulvérisation ayant une taille de particule d'aérosol/médicament atomisé pouvant être régulée et une distance de distribution pour une administration nasale selon la présente invention, le dépôt de médicament dans le poumon peut être évité, et les médicaments peuvent être administrés avec précision à des sites malades dans une cavité nasale et une cavité nasale secondaire et agissent directement sur les sinus paranasaux pour fournir un traitement continu. La présente invention concerne en outre un système d'administration.
PCT/CN2022/079836 2021-03-23 2022-03-09 Dispositif de pulvérisation pour administration nasale et système d'administration Ceased WO2022199379A1 (fr)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
CN202120587738.8 2021-03-23
CN202120587738.8U CN214911992U (zh) 2021-03-23 2021-03-23 鼻喷雾化器
CN202110314650.3 2021-03-24
CN202110314650.3A CN112957572A (zh) 2021-03-24 2021-03-24 鼻腔给药的喷雾装置及给药系统

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CN104001244A (zh) * 2014-05-20 2014-08-27 江苏康诺医疗器械有限公司 一种多功能喷雾罐
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WO2019049178A1 (fr) * 2017-09-06 2019-03-14 3A Health Care S.R.L. Dispositif de thérapie par aérosol
US20200001024A1 (en) * 2018-06-28 2020-01-02 Yi-Jin Promold Enterprise Ltd. Liquid atomizing device
CN112957572A (zh) * 2021-03-24 2021-06-15 合肥启灏医疗科技有限公司 鼻腔给药的喷雾装置及给药系统
CN214911992U (zh) * 2021-03-23 2021-11-30 合肥启灏医疗科技有限公司 鼻喷雾化器

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CN102753228A (zh) * 2009-12-08 2012-10-24 美德英文特有限公司 用于鼻腔冲洗及给药的方法
CN104159632A (zh) * 2012-03-07 2014-11-19 美德英文特有限公司 便携式喷雾器
CN104001244A (zh) * 2014-05-20 2014-08-27 江苏康诺医疗器械有限公司 一种多功能喷雾罐
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CN112957572A (zh) * 2021-03-24 2021-06-15 合肥启灏医疗科技有限公司 鼻腔给药的喷雾装置及给药系统

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* Cited by examiner, † Cited by third party
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CN118010944A (zh) * 2024-03-14 2024-05-10 济南市第三人民医院 一种用于检测鼻部给药的分析装置

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