WO2022199379A1 - Spraying device for nasal administration and administration system - Google Patents

Spraying device for nasal administration and administration system 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
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WO
WIPO (PCT)
Prior art keywords
liquid storage
cup
spray device
cup cover
nasal administration
Prior art date
Application number
PCT/CN2022/079836
Other languages
French (fr)
Chinese (zh)
Inventor
张晓芳
宋保组
储成生
谢勇
逄永刚
Original Assignee
合肥启灏医疗科技有限公司
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/en
Priority claimed from CN202110314650.3A external-priority patent/CN112957572A/en
Application filed by 合肥启灏医疗科技有限公司 filed Critical 合肥启灏医疗科技有限公司
Publication of WO2022199379A1 publication Critical patent/WO2022199379A1/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
    • 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
    • A61M11/02Sprayers 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
    • 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
    • A61M15/00Inhalators
    • 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
    • A61M31/00Devices 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.

Abstract

The present invention provides a spraying device for nasal administration, the device comprising: a liquid storage cup, which comprises a vent with a diameter ranging from 0.35 mm to 2.5 mm, and an airflow channel portion with a height ranging from 0.7 mm to 6.0 mm and in communication with the vent; a liquid storage cup lid which fits the liquid storage lid and which comprises an atomization nozzle with a diameter ranging from 0.5 mm to 3 mm and a fluid channel portion in communication with the atomization nozzle, wherein after the liquid storage cup is fitted to the liquid storage cup lid, a conveying portion with a diameter ranging from 0.002 mm to 0.5 mm is provided between an outer surface of the airflow channel portion and an inner surface of the fluid channel portion; a main control portion for controlling the magnitudes of drug delivery airflow and air pressure; and a two-way airflow cannula for conveying a drug spray. According to the spraying device with controllable atomized aerosol/drug particle size and delivery distance for nasal administration provided in the present invention, drug deposition in the lung can be avoided, and drugs can be accurately delivered to diseased sites in a nasal cavity and a secondary nasal cavity and directly act on paranasal sinuses to provide continuous treatment. The present invention further provides an administration system.

Description

鼻腔给药的喷雾装置及给药***Spray device and drug delivery system for nasal administration
交叉引用cross reference
本申请要求2021年3月24日提交的申请号为202110314650.3的中国专利申请的优先权和2021年3月23日提交的申请号为202110314650.3的中国专利申请的优先权202120587738.8,上述申请的内容以引用方式被包含于此。This application claims the priority of the Chinese Patent Application No. 202110314650.3 filed on March 24, 2021 and the priority of the Chinese Patent Application No. 202110314650.3 filed on March 23, 2021 202120587738.8, the contents of the above applications are cited by reference The way is included here.
技术领域technical field
本发明涉及雾化器领域,尤其是一种鼻腔给药的喷雾装置及给药***。The invention relates to the field of atomizers, in particular to a spray device and a drug delivery system for nasal administration.
技术背景technical background
常用的滴鼻液颗粒为50-100微米,该尺寸下的鼻液颗粒注入鼻腔后均会被鼻阀有效过滤,因此气溶胶形态的药物和生理盐水只滞留在鼻腔前端10厘米的位置,不会到达后鼻腔和鼻窦的位置。现有的鼻/肺雾化器的优势是它可以提供小于5微米的小微粒气溶胶,提高药物在鼻阀沉积的数量。然而,上颌窦与鼻腔之间的气道较小,直径仅有小于5毫米,会限制气溶胶进入上颌窦,此外,体外和体内研究表明,通过鼻喷喷雾器进入鼻腔的气溶胶大约有33-58%进入肺部,增加了副作用的风险,有潜在的肺毒性作用。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. However, 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 addition, 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.
公开号为CN103917265B的中国发明专利公开了一种递送从推进剂和药物制剂衍生的羽流的化合物递送装置。所述药物制剂以粉末、悬浮液、分散液或液体形式存在于鼻内剂型中。被推进的鼻内剂型沉积在鼻腔的嗅觉区内。沉积在嗅觉区内的药物被递送给大脑,从而避开血脑障壁。将来自加压罐的氢氟烷烃推进剂引导到扩散器和含药室,在此使鼻内剂型气雾化。气雾 化的鼻内剂型穿过喷嘴,从而将羽流递送到用户鼻腔的嗅觉区。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.
然而,目前每一种雾化装置都有自己的问题,还没有一款针对鼻部给药的雾化装置,可以精准的将药物送达后鼻腔和鼻窦(如筛窦,额窦,上颌)局部位置,且不会随呼吸将药物送达肺部。However, 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.
因此,有必要提供一种鼻腔给药的喷雾装置及***以解决现有技术中存在的上述问题。Therefore, it is necessary to provide a spray device and system for nasal administration to solve the above-mentioned problems in the prior art.
发明概要Summary of Invention
本发明提供了一种鼻腔给药的喷雾装置,通过设计合理尺寸的出气孔、气流通道部、雾化喷嘴以及气流通道部的外表面和所述流体通道部的内表面之间输送部,能够有利于控制鼻腔给药的喷雾装置雾化药剂颗粒的大小和尺寸分布,同时,通过控制***控制所述鼻腔给药的喷雾装置的给药气流和气压的大小维持在设定值,将药物喷剂通过双向气流插管准确地输送至鼻腔和副鼻腔内的病变部位并直接作用于鼻窦,为鼻窦狭窄的部位提供持续的治疗。The present invention provides 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.
为实现上述目的,本发明所述的鼻腔给药的喷雾装置,包括储液杯,用以储存药物喷剂,所述储液杯包括出气孔和与所述出气孔相连通的气流通道部,所述出气孔的直径为0.35毫米-2.5毫米,所述气流通道部的高度为0.7-6.0毫米;储液杯盖,与所述储液杯适配,所述储液杯盖包括雾化喷嘴和与所述雾化喷嘴相连通的流体通道部,所述雾化喷嘴的直径为0.5毫米-3毫米;所述流体通道部的直径大于所述气流通道部的直径,所述储液杯与所述储液杯盖适配后,所述气流通道部的外表面和所述流体通道部的内表面之间形成输送部,所述输送部的直径为0.002毫米-0.5毫米;控制***,用以控制所述 鼻腔给药的喷雾装置的给药气流和气压的大小维持在设定值;双向气流插管,用以输送所述储液杯中的药物喷剂。In order to achieve the above object, 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 After the liquid storage cup cover is fitted, 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 set value; the bidirectional gas flow cannula is used to deliver the drug spray in the liquid storage cup.
本发明的有益效果在于:所述出气孔的直径在0.35毫米-2.5毫米之间,所述气流通道部的高度在0.7-6.0毫米之间,所述雾化喷嘴的直径在0.5毫米-3毫米之间,所述输送部的直径在0.002毫米-0.5毫米之间,通过将所述出气孔、所述气流通道部、所述雾化喷嘴以及所述输送部的尺寸控制在上述范围,有利于控制鼻腔给药的喷雾装置雾化药剂颗粒的大小和尺寸分布在5-43微米之间,满足鼻腔治疗的喷雾粒径条件避免肺部药物沉积,同时,通过控制***控制所述鼻腔给药的喷雾装置的给药气流和气压的大小维持在设定值,将药物喷剂通过双向气流插管准确地输送至鼻腔和副鼻腔内的病变部位并直接作用于鼻窦,为鼻窦狭窄的部位提供持续的治疗。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. By controlling the dimensions of the air outlet hole, the air flow channel part, the atomizing nozzle and the conveying part within the above range, it is beneficial to The size and size distribution of the atomized drug particles of the spray device for controlling nasal administration is between 5-43 microns, which meets the spray particle size conditions for nasal treatment to avoid drug deposition in the lungs, and at the same time, the control system controls the nasal administration. 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.
可选地,所述储液杯包括圆柱形基体、排放管和底部杯壁,所述圆柱形基体、所述排放管、所述底部杯壁与所述气流通道部共同构成药剂的储存空间,所述排放管设置于所述圆柱形基体的侧壁上,所述底部杯壁连接所述气流通道部与所述圆柱形基体。Optionally, 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.
可选地,所述底部杯壁包括对称设置的凹陷部,所述凹陷部设置于靠近所述流体通道的一侧。其有益效果在于:所述凹陷部用以收集药物喷剂。Optionally, 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.
可选地,所述圆柱形基体、所述底部杯壁、所述气流通道部与所述排放管为一体式结构。Optionally, the cylindrical base body, the bottom cup wall, the air flow channel portion and the discharge pipe are of an integral structure.
可选地,所述储液杯还包括储液杯盖连接部,设置于所述圆柱形基体远离所述底部杯壁的一侧。其有益效果在于:所述储液杯盖连接部用以适配所述储液杯盖,形成药物喷剂的储存空间。Optionally, 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.
可选地,所述储液杯盖包括与所述圆柱形基体适配的喷射室外壁和与所述储液杯盖连接部适配的连接内壁,所述喷射室外壁、所述连接内壁、所述雾化喷嘴和所述流体通道部共同构成气体喷射室。Optionally, 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.
可选地,所述储液杯盖还包括固定部,所述固定部设置于所述储液杯盖的中心轴线处,以可拆卸连接所述储液杯与所述储液杯盖。Optionally, 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.
可选地,所述储液杯盖还包括适配于所述雾化喷嘴的气体控制器,所述气体控制器设置于所述雾化喷嘴远离所述流体通道部的一侧,并与所述喷射室外壁相连接。其有益效果在于:所述气体控制器在喷射室的底部末端形成阻挡以控制气体流速。Optionally, 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.
可选地,所述流体通道部内侧设有至少一个内置沟槽。其有益效果在于:所述内置沟槽与所述流体通道部的外壁和所述流体通道部的内壁形成连通所述凹陷部的狭小的液体吸入通道,将所述凹陷部收集的药物喷剂引流至所述雾化喷嘴。Optionally, 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.
可选地,所述储液杯还包括存储部、液体杯座和支撑部,所述液体杯座与所述存储部的底部相连接,形成药物喷剂的存储空间,所述支撑部与所述液体杯座相连接,并设置在所述液体杯座远离所述出气孔的一侧。其有益效果在于:所述存储部与所述液体杯座构成药物喷剂的存储空间,所述支撑部可以让所述鼻腔给药的喷雾装置直立在连接所述鼻腔给药的喷雾装置的主机的上水平表面。Optionally, 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 beneficial effect is that: the storage part and the liquid cup holder constitute a storage space for the medicinal spray, and the support part can make the spray device for nasal administration stand upright on the main engine connected to the spray device for nasal administration the upper horizontal surface.
可选地,所述储液杯包括与所述气流通道部连通的柱形管,所述柱形管与所述液体杯座适配,并设置于所述存储部的内侧。Optionally, 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.
可选地,所述柱形管还包括进气***口,所述进气***口与所述气流通 道部连通设置。其有益效果在于:所述进气***口用以提供雾化药物喷剂的气体,使所述气体进入所述气流通道部,通过所述出气口后形成气流。Optionally, 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 beneficial effect is that: 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.
可选地,所述储液杯还包括至少一个水平标记或至少一个标线,以指示液位。Optionally, the liquid storage cup further includes at least one horizontal mark or at least one reticle to indicate the liquid level.
可选地,所述储液杯盖包括扩展杯盖、杯罩、杯盖底座,所述扩展杯盖设置于所述流体通道部与所述杯罩之间,并沿所述储液杯盖远离轴线方向凸出,以适配所述存储部,所述杯罩设置于所述扩展杯盖与所述杯盖底座之间,以适配所述柱形管,所述杯盖底座设置于所述杯罩远离所述扩展杯盖的一侧,与所述储液杯相适配。其有益效果在于:所述扩展杯盖与所述存储部适配以防止液体从所述储液杯中溢出,所述杯罩和所述柱形管适配后形成所述气流通道部的外表面和所述流体通道部的内表面之间的输送部以存储待雾化的药物喷剂。Optionally, 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.
可选地,所述杯盖底座还包括至少一个杯盖凹槽,以在所述储液杯与所述杯盖底座之间形成液体流通通道。其有益效果在于:所述杯盖凹槽用以使所述药物喷剂可以从所述储液杯中流入所述气流通道部的外表面和所述流体通道部的内表面之间的输送部中。Optionally, 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 beneficial effect is that: 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.
可选地,所述流体通道部还包括设置于所述流体通道部的外侧面的回流部,所述回流部包括延伸凹槽和垂直沟槽,所述垂直沟槽从所述雾化喷嘴处的外侧面缘延伸至所述杯罩处,所述延伸凹槽与所述杯罩侧的所述垂直沟槽的端部相连接,并垂直于所述流体通道部的外侧面。其有益效果在于:所述回流部用以引流掉落的药物喷剂。Optionally, 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 beneficial effect is that the backflow part is used for draining the dropped medicine spray.
可选地,所述回流部还包括至少一个回流孔,以将所述储液杯盖的外部 与所述储液杯的内腔相连通。其有益效果在于:所述回流孔通过内外气压差将掉落的药物喷剂压回至所述存储部,从而最大限度地减少药物喷剂的浪费。Optionally, 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.
可选地,所述控制***包括鼻腔喷雾泵,与所述气流通道部连接,用以向所述鼻腔给药的喷雾装置提供气流。Optionally, the control system includes a nasal spray pump connected to the air flow channel portion for providing air flow to the nasal spray device.
可选地,所述控制***还包括主控部,所述主控部通信连接所述鼻腔喷雾泵,以控制供气气流和气压。Optionally, the 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.
可选地,所述主控部包括与所述主控部通讯连接的驱动模块、监测模块和记时模块,所述驱动模块用以向所述鼻腔喷雾泵提供驱动力,所述监测模块用以实时监测并记录所述驱动力的大小,所述记时模块用以记录所述驱动模块施加驱动力的上升时间、保持时间、下降时间和喷雾延迟时间。Optionally, 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. To monitor and record the magnitude of the driving force in real time, 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.
可选地,所述双向气流插管包括气凝胶输送管和加压空气输送管,所述气凝胶输送管用以将药物喷剂输送到第一个鼻腔的病变部位,所述加压空气输送管用以将加压空气输送入第二个鼻腔来封闭鼻腔呼吸***。其有益效果在于:所述双向气流插管用以在治疗时封闭鼻腔呼吸***,以将雾化药剂持续注入鼻腔。Optionally, 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.
可选地,所述气凝胶输送管包括气凝胶出口、气凝胶软管接口和气凝胶插管连接处外壁,所述气凝胶出口和所述气凝胶软管接口设置在所述气凝胶输送管的两端,所述气凝胶插管连接处外壁适配于所述排放管,所述气凝胶出口设置在所述气凝胶输送管远离所述气凝胶插管连接处外壁的一侧。Optionally, 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. One side of the outer wall of the pipe connection.
可选地,所述加压空气输送管包括加压空气出口和加压空气***口,所述加压空气出口和所述加压空气***口设置在所述加压空气输送管的两端, 所述加压空气出口设置在靠近所述气凝胶出口的一侧。Optionally, 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.
本发明还提供了一种给药***,包括所述鼻腔给药的喷雾装置。The present invention also provides a drug delivery system, comprising the spray device for nasal drug delivery.
附图说明Description of drawings
图1为本发明的实施例一中所述储液杯的主视图;1 is a front view of the liquid storage cup described in Embodiment 1 of the present invention;
图2为本发明的实施例一中所述储液杯盖的主视图;Fig. 2 is the front view of the liquid storage cup cover described in the first embodiment of the present invention;
图3为本发明的实施例一中所述鼻腔给药的喷雾装置的示意图;3 is a schematic diagram of the spray device for nasal administration described in Example 1 of the present invention;
图4为本发明的实施例一中所述主控部的框架图;FIG. 4 is a frame diagram of the main control unit described in Embodiment 1 of the present invention;
图5为本发明的实施例一中所述双向气流插管的示意图;5 is a schematic diagram of the bidirectional airflow cannula described in Embodiment 1 of the present invention;
图6为本发明的实施例一中所述双向气流插管的俯视图;6 is a top view of the bidirectional airflow cannula described in Embodiment 1 of the present invention;
图7为本发明的实施例一中所述双向气流插管的截面图;7 is a cross-sectional view of the bidirectional airflow cannula described in Embodiment 1 of the present invention;
图8为本发明的实施例一中所述双向气流插管的前视图。FIG. 8 is a front view of the bidirectional airflow cannula according to the first embodiment of the present invention.
图9为本发明的实施例二中储液杯的主视图;Fig. 9 is the front view of the liquid storage cup in the second embodiment of the present invention;
图10为本发明的实施例二中储液杯的结构示意图;10 is a schematic structural diagram of a liquid storage cup in Embodiment 2 of the present invention;
图11为本发明的实施例二中储液杯盖的主视图;Fig. 11 is the front view of the liquid storage cup cover in the second embodiment of the present invention;
图12为本发明的实施例二中储液杯盖的结构示意图;12 is a schematic structural diagram of a liquid storage cup cover in Embodiment 2 of the present invention;
图13为本发明的实施例二中储液杯盖***储液杯后所形成结构的切面图;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;
图14为本发明的实施例二中储液杯盖***储液杯后所形成结构的俯视图。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.
附图中的附图标记分别为:The reference signs in the accompanying drawings are:
1-储液杯;11-出气孔;12-气流通道部;13-存储部;14-液体杯座;15- 支撑部;16-柱形管;17-进气***口;18-圆柱形基体;181-储液杯盖连接部;19-排放管;10-底部杯壁;101-凹陷部;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-储液杯盖;21-雾化喷嘴;211-气体控制器;22-流体通道部;221-内置沟槽;23-扩展杯盖;24-杯罩;25-杯盖底座;26-杯盖凹槽;27-回流部;271-延伸凹槽;272-垂直凹槽;28-喷射室外壁;29-连接内壁;20-固定部;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;
3-输送部;3-Conveying part;
4-主控部;41-驱动模块;42-监测模块;43-记时模块;4-main control part; 41-drive module; 42-monitoring module; 43-timing module;
5-双向气流插管;51-气凝胶输送管;511-气凝胶出口;512-气凝胶软管接口;513-气凝胶插管连接处外壁;52-加压空气输送管;521-加压空气出口;522-加压空气***口。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.
发明内容SUMMARY OF THE INVENTION
实施例一Example 1
针对现有技术存在的问题,本发明实施例一提供一种鼻腔给药的喷雾装置,图1为本发明的实施例一中所述储液杯的主视图,图2为本发明的实施例一中所述储液杯盖的主视图,图3为本发明的实施例一中所述鼻腔给药的喷雾装置的示意图,图4为本发明的实施例一中所述主控部的框架图,图5为本发明的实施例一中所述双向气流插管的示意图。In view of the existing problems in the prior art, 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, and 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, and 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.
结合图1至图5所示的鼻腔给药的喷雾装置为例,本发明的实施例一的所述鼻腔给药的喷雾装置包括:储液杯1,用以储存药物喷剂,所述储液杯1包括出气孔11和与所述出气孔11相连通的锥形的气流通道部12,所述出气孔11的直径在0.35毫米-2.5毫米之间,所述气流通道部12的高度在0.7-6.0 毫米之间;储液杯盖2,与所述储液杯1适配,所述储液杯盖2包括雾化喷嘴21和与所述雾化喷嘴21相连通的流体通道部22,所述雾化喷嘴21的直径在0.5毫米-3毫米之间;所述流体通道部22的直径大于所述气流通道部12的直径,所述储液杯1与所述储液杯盖2适配后,所述气流通道部12的外表面和所述流体通道部22的内表面之间具有输送部3,所述输送部3的直径在0.002毫米-0.5毫米之间。Taking the spray device for nasal administration shown in FIG. 1 to FIG. 5 as an example, the spray device for nasal administration according to Embodiment 1 of the present invention 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.
在某些具体的实施例中,根据表1所示鼻腔给药的喷雾装置喷嘴结构内外孔径和输送部的设计条件对所述出气孔11的直径、所述雾化喷嘴21的直径和所述输送部3的尺寸进行限定,所述输送部3的尺寸为所述储液杯与所述储液杯盖的配合间隙。In some specific embodiments, 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.
表1Table 1
Figure PCTCN2022079836-appb-000001
Figure PCTCN2022079836-appb-000001
根据所述出气孔11的直径、所述雾化喷嘴21的直径和所述输送部3的直径尺寸限制设计所述鼻腔给药的喷雾装置的15个设计方案,如表2所示,将表2中的15个不同尺寸的鼻腔给药的喷雾装置通过注塑/3D打印,通过输入不同压强,包括50kPa、70kPa、100kPa、150kPa、200kPa和250kPa的空气,测试各鼻腔给药的喷雾装置在各个气体压强下产生的气溶胶的粒径分布,并通过激光衍射法喷雾粒度分析***(Malvern,Spraytec)计算出体积平均直径(Volume Mean Diameter,VMD)和粒径分布比例。气溶胶直径占总气溶胶体积的比例小于10%、50%和90%(分别为D10、D50和D90)是主要指标,为了避免对气溶胶尺寸范围拟合特定分布的需求,确定了一个跨 度值RS,RS=[(D90-D10)/D50]。表2中组合序列代表不同鼻腔给药的喷雾装置的代码。According to the diameter of the air outlet 11, the diameter of the atomizing nozzle 21 and the diameter of the conveying part 3, there are 15 design schemes for designing the spray device for nasal administration, as shown in Table 2. In 2, 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 ratio of aerosol diameter to total aerosol volume of less than 10%, 50% and 90% (D10, D50 and D90, respectively) is the main indicator, and to avoid the need for aerosol size ranges to fit a specific distribution, a span was identified Value RS, RS=[(D90-D10)/D50]. The combined sequences in Table 2 represent the codes for the different nasally administered spray devices.
表2Table 2
   影响因子1 Impact factor 1 影响因子2 Impact factor 2 影响因子3Impact factor 3
组合序列Combination sequence A:出气孔直径(毫米)A: Outlet diameter (mm) B:雾化喷嘴直径(毫米)B: Atomizing nozzle diameter (mm) C:配合间隙(毫米)C: Fitting clearance (mm)
NNXS01NNXS01 2.06972.0697 3.00003.0000 0.46520.4652
NNXS02NNXS02 0.57020.5702 1.90081.9008 0.20120.2012
NNXS03NNXS03 0.57020.5702 1.90081.9008 0.20120.2012
NNXS04NNXS04 0.90000.9000 3.00003.0000 0.48760.4876
NNXS05NNXS05 1.21391.2139 1.63301.6330 0.20950.2095
NNXS06NNXS06 0.90000.9000 3.00003.0000 0.00200.0020
NNXS07NNXS07 0.90000.9000 3.00003.0000 0.25100.2510
NNXS08NNXS08 1.83351.8335 3.00003.0000 0.15140.1514
NNXS09NNXS09 0.42860.4286 1.42861.4286 0.50000.5000
NNXS10NNXS10 2.50002.5000 2.50402.5040 0.00200.0020
NNXS11NNXS11 1.18761.1876 2.01672.0167 0.41460.4146
NNXS12NNXS12 1.21001.2100 1.97501.9750 0.00200.0020
NNXS13NNXS13 0.35000.3500 0.79470.7947 0.22240.2224
NNXS14NNXS14 0.35000.3500 0.50000.5000 0.00200.0020
NNXS15NNXS15 1.83351.8335 3.00003.0000 0.15140.1514
上述15个设计方案在250KPa压强下的雾化粒子分析结果如表3所示。表三中的第一比值为所述雾化喷嘴12与所述出气孔11的直径之比,第二比值为所述输送部3的尺寸与所述出气孔11的直径之比,所述输送部3的尺寸为所述储液杯与所述储液杯盖的配合间隙。在测量过程中,表3记录了各个鼻腔给药的喷雾装置在250KPa压强下响应的D10、D50、D90和RS的大小,来评估据所述出气孔11的直径、所述雾化喷嘴21的直径、所述输送部3的直径尺寸和所述主控部输入的气体压强对所述鼻腔给药的喷雾装置的喷雾粒径之间的实证关系。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. During the measurement process, 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.
表3table 3
Figure PCTCN2022079836-appb-000002
Figure PCTCN2022079836-appb-000002
表4展示了通过设计软件(DOE)计算三个影响因子的影响参数,优选的3组在压强为250KPa下最佳喷嘴设计参数的雾化颗粒分析。具体的,将所述鼻腔给药的喷雾装置的不同设计组合以及粒度分析结果输入设计软件(DOE),通过设计软件分析生成最佳设计参数,包括生成15-40微米气溶胶的所述鼻腔给药的喷雾装置的设计参数和生成2-10微米气溶胶的所述鼻腔给药的喷雾装置的设计参数,设计参数包括:A-出气口的直径;B-雾化喷嘴的直径;C-输送部宽度;D-输入的气体压强。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. Specifically, the different design combinations of the spray device for nasal administration and the particle size analysis results are input into the design software (DOE), and the optimal design parameters are generated through the analysis of the design software, including generating the nasal administration of 15-40 micron aerosols. The design parameters of the spray device for medicine and the design parameters of the spray device for nasal administration to generate 2-10 micron aerosols, the design parameters include: A - the diameter of the air outlet; B - the diameter of the atomizing nozzle; C - the delivery Section width; D-input gas pressure.
表4Table 4
Figure PCTCN2022079836-appb-000003
Figure PCTCN2022079836-appb-000003
在某些优选的实施例中,如表4所示,优选的鼻腔给药的喷雾装置的所述出气口的直径为0.8015毫米、所述雾化喷嘴的直径为1.27毫米、所述输送部的宽度为0.0518毫米。In certain preferred embodiments, as shown in Table 4, 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, and the diameter of the delivery part is 0.8015 mm. The width is 0.0518 mm.
在一种优选的实施例中,如表4所示,优选的鼻腔给药的喷雾装置的所述出气口的直径为0.7毫米、所述雾化喷嘴的直径为1.15毫米、所述输送部的宽度为0.05毫米。In a preferred embodiment, as shown in Table 4, 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, and the diameter of the delivery part is 0.7 mm. The width is 0.05mm.
在另一种优选的实施例中,如表4所示,优选的鼻腔给药的喷雾装置的所述出气口的直径为0.78毫米、所述雾化喷嘴的直径为1.16毫米、所述输送部的宽度为0.025毫米。In another preferred embodiment, as shown in Table 4, 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, and the delivery portion The width is 0.025 mm.
在一种具体的实施例中,如图1所示,所述储液杯1包括圆柱形基体18、排放管19和底部杯壁10,所述圆柱形基体18、所述排放管19、所述底部杯壁10与所述气流通道部12共同构成药剂的储存空间,所述排放管19设置于所述圆柱形基体18的侧壁上,所述底部杯壁10连接设置所述气流通道部12与所述圆柱形基体18。In a specific embodiment, as shown in FIG. 1 , 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 .
进一步,所述底部杯壁10包括对称设置的凹陷部101,所述凹陷部101设置于靠近所述气流通道部12的一侧以收集药物喷剂。Further, 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.
在某些具体的实施例中,如图1所示,所述圆柱形基体18、所述底部杯壁10、所述气流通道部12与所述排放管19为一体式结构。In some specific embodiments, as shown in FIG. 1 , the cylindrical base body 18 , the bottom cup wall 10 , the airflow channel portion 12 and the discharge pipe 19 are integral structures.
进一步,结合图1和图2所示,所述储液杯1还包括储液杯盖连接部181,设置于所述圆柱形基体18远离所述底部杯壁10的一侧,所述储液杯盖连接部181用以适配所述储液杯盖2,形成药物喷剂的储存空间。Further, as shown in FIGS. 1 and 2 , 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.
在某些具体的实施例中,结合图1和图2所示,所述储液杯盖2包括与所述圆柱形基体18适配的喷射室外壁28和与所述储液杯盖连接部181适配的连接内壁29,所述喷射室外壁28、所述连接内壁29、所述雾化喷嘴21和所述流体通道部22共同构成气体喷射室。In some specific embodiments, as shown in FIG. 1 and FIG. 2 , 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.
优选的,结合图1和图2所示,所述储液杯盖2还包括固定部20,所述固定部20设置于所述储液杯盖2的中心轴线处,以可拆卸连接所述储液杯1与所述储液杯盖2。Preferably, as shown in FIG. 1 and FIG. 2 , 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.
优选的,如图2所示,所述储液杯盖2还包括适配于所述雾化喷嘴21的气体控制器211,所述气体控制器211设置于所述雾化喷嘴21远离所述流体通道部22的一侧,并与所述喷射室外壁28相连接,所述气体控制器211在喷射室的底部末端形成阻挡以控制气体流速。Preferably, as shown in FIG. 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.
优选的,结合图1和图2所示,所述流体通道部22内侧设有至少一个内置沟槽221,所述内置沟槽221与所述流体通道部22的外壁和所述流体通道部22的内壁形成连通所述凹陷部101的狭小的液体吸入通道,将所述凹陷部101收集的药物喷剂引流至所述雾化喷嘴21。Preferably, as shown in FIG. 1 and FIG. 2 , 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 .
在某些具体的实施例中,如图3所示,所述控制***包括鼻腔喷雾泵(图中未示出),与所述气流通道部12连接,用以向所述鼻腔给药的喷雾装置提供气流。In some specific embodiments, as shown in FIG. 3 , the 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.
进一步,如图4所示,所述控制***还包括主控部4,所述主控部4通 信连接所述鼻腔喷雾泵(图中未示出),以控制供气气流和气压。Further, as shown in Fig. 4 , the 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.
在一种具体的实施例中,如图4所示,所述主控部4包括与所述主控部4通讯连接的驱动模块41、监测模块42和记时模块43,所述驱动模块41用以向所述鼻腔喷雾泵(图中未示出)提供驱动力,所述监测模块42用以实时监测并记录所述驱动力的大小,所述记时模块43用以记录所述驱动模块41施加驱动力的上升时间、保持时间、下降时间和喷雾延迟时间。In a specific embodiment, as shown in FIG. 4 , 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.
具体的,所述监控模块42实时监测和记录所述驱动力的大小,并将记录结果发送至所述主控部4,所述主控部4通过控制所述驱动模块41使所述驱动力的大小维持在设定值,以获得稳定的给药气流和气压。需要说明的使,所述驱动力设定值的范围在50-250KPa,根据鼻腔内病变部位的治疗效果进行调整。Specifically, 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. 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.
进一步,所述控制***通过设定所述驱动力、所述驱动力的上升时间、保持时间和下降时间来控制所述供气气流和气压的大小,所述驱动力的上升时间、保持时间和下降时间根据每次鼻腔病变部位的治疗情况进行调整。Further, the 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.
具体的,设定所述驱动模块41的驱动力大小为4.5kg,并设置所述计时模块43的驱动力上升时间为0.3s、保持时间为2.0s、下降时间为65s和喷雾延迟时间为1s,所述主控部4根据所述设置参数控制所述鼻腔喷雾泵(图中未示出)提供气流和气压,测量所述鼻腔给药的喷雾装置喷出的液滴尺寸分布。Specifically, the driving force of the driving module 41 is set to be 4.5kg, and 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.
液滴尺寸分布的测量在室温下进行,所使用的镜头焦距为100毫米,气溶胶大小范围为0.5-200微米,折射率和吸收系数的分别设置为1.00+0.00i(空气)和1.33+0.00i(水)。数据以体积直径定义为10%、50%和90%的累积体积 大小(分别命名为Dv10、Dv50和Dv90)。滴液分布表示为RS=(Dv90-Dv10)/Dv50。Droplet size distribution measurements were performed at room temperature using a lens with a focal length of 100 mm, aerosol size range of 0.5–200 μm, and refractive index and absorption coefficients set to 1.00+0.00i (air) and 1.33+0.00, respectively i (water). Data are defined as 10%, 50% and 90% cumulative volume size in volume diameter (designated Dv10, Dv50 and Dv90, respectively). The drop distribution is expressed as RS=(Dv90-Dv10)/Dv50.
在250KPa的压强下,测试3组不同尺寸的所述鼻腔给药的喷雾装置的雾化颗粒的尺寸分布,如表5所示。NNXS06、13和15的D10分别是4.7、16.1和11.3微米,同时这三个喷嘴的结构得到的雾化颗粒D90分别为42.7、65.2和89微米,其中NNXS06的雾化颗粒分布窄,且90%的颗粒在5-43微米之间,最接近本发明的设计目标,为本发明的优选条件。Under the pressure of 250KPa, 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.
表5table 5
Figure PCTCN2022079836-appb-000004
Figure PCTCN2022079836-appb-000004
在一种具体的实施例中,结合图5-图8所示,所述双向气流插管5包括气凝胶输送管51和加压空气输送管52,所述气凝胶输送管51用以将药物喷剂输送到第一个鼻腔的病变部位,所述加压空气输送管52用以将加压空气输送入第二个鼻腔来封闭鼻腔呼吸***。所述双向气流插管5用以在治疗时封闭鼻腔呼吸***,以将雾化药剂持续注入鼻腔。In a specific embodiment, as shown in FIGS. 5-8 , 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.
进一步,结合图3、图5和图6所述气凝胶输送管51包括气凝胶出口511、气凝胶软管接口512和气凝胶插管连接处外壁513,所述气凝胶出口511和所述气凝胶软管接口512设置在所述气凝胶输送管51的两端,所述气凝胶插管连接处外壁513与所述排放管19适配,可以通过旋转拆卸或连接,所述气凝胶出口511设置在所述气凝胶输送管51远离所述气凝胶插管连接处外壁513的一侧。Further, 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.
进一步,结合图5至图8所示,所述加压空气输送管52包括加压空气出口521和加压空气***口522,所述加压空气出口521和所述加压空气***口522设置在所述加压空气输送管52的两端,所述加压空气出口521设置在靠近所述气凝胶出口511的一侧。Further, as shown in FIGS. 5 to 8 , 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 .
在一些优选的实施例中,所述储液杯1还包括至少一个水平标记或至少一个标线(图中未示出),以指示特定的液位。In some preferred embodiments, 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.
实施例二 Embodiment 2
针对现有技术存在的问题,本发明的实施例二提供一种鼻腔给药的喷雾装置,图9为本发明的实施例二中储液杯的主视图,图10为本发明的实施例二中储液杯的结构示意图,图11为本发明的实施例二中储液杯盖的主视图,图12为本发明的实施例二中储液杯盖的结构示意图,图13为本发明的实施例二中储液杯盖***储液杯后所形成结构的切面图,图14为本发明的实施例二中储液杯盖***储液杯后所形成结构的俯视图。In view of the problems existing in the prior art, the second embodiment of the present invention provides a spray device for nasal administration. FIG. 9 is a front view of the liquid storage cup in the second embodiment of the present invention, and 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, and 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.
结合图9至图14所示,本发明实施例二的所述鼻腔给药的喷雾装置包括:储液杯1,用以储存药物喷剂,所述储液杯1包括出气孔11和与所述出气孔11相连通的锥形的气流通道部12,所述出气孔11的直径在0.35毫米-2.5毫米之间,所述气流通道部12的高度在0.7-6.0毫米之间;储液杯盖2,与所述储液杯1适配,所述储液杯盖2包括雾化喷嘴21和与所述雾化喷嘴21相连通的流体通道部22,所述雾化喷嘴21的直径在0.5毫米-3毫米之间;所述流体通道部22的直径大于所述气流通道部12的直径,所述储液杯1与所述储液杯盖2适配后,所述气流通道部12的外表面和所述流体通道部22的内表面之间具有输送部3,所述输送部3的直径在0.002毫米-0.5毫米之 间。With reference to FIGS. 9 to 14 , the spray device for nasal administration according to the second embodiment of the present invention 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.
在某些具体的实施例中,如图9所示,所述储液杯1还包括存储部13、液体杯座14和支撑部15,所述液体杯座14与所述存储部13的底部相连接,形成药物喷剂的存储空间,所述支撑部15与所述液体杯座14相连接,并设置在所述液体杯座14远离所述出气孔11的一侧以让所述鼻腔给药的喷雾装置直立在连接所述鼻腔给药的喷雾装置的主机的上水平表面。In some specific embodiments, as shown in FIG. 9 , 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 . connected to form a storage space for medicinal sprays, 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.
进一步,所述储液杯1包括柱形管16,与所述气流通道部12连通,并与所述液体杯座14连接并适配,设置于所述存储部13的内侧。Further, 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 .
在某些具体的实施例中,如图9所示,所述柱形管16设置在所述气流通道部12的下端,所述液体杯座14为圆形,所述支撑部15的数量为双数以支承所述液体杯座14。In some specific embodiments, as shown in FIG. 9 , 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 .
进一步,结合图9和图13所示,所述柱形管16还包括进气***口17,所述进气***口17与所述气流通道部12连通设置,所述进气***口17用以提供雾化药物喷剂的气体,使所述气体进入所述气流通道部12,通过所述出气口11后形成气流,所述进气***口17用以连接向所述鼻腔给药的喷雾装置内提供气体的空气压缩机的对接端口,使设备可以为鼻腔给药的喷雾装置持续提供加压空气。Further, as shown in FIG. 9 and FIG. 13 , 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 In order to provide the gas of the aerosolized drug spray, 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.
在一些优选的实施例中,所述储液杯1还包括至少一个水平标记或至少一个标线(图中未示出),以指示特定的液位。In some preferred embodiments, 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.
在某些具体的实施例中,结合图10和图11所示,所述储液杯盖2包括扩展杯盖23、杯罩24、杯盖底座25;所述扩展杯盖23设置于所述流体通道部22与所述杯罩24之间,并沿所述储液杯盖2的外侧方向向外凸出,以适 配所述存储部13以防止液体从所述储液杯1中溢出;所述杯罩24设置于所述扩展杯盖23与所述杯盖底座25之间,以适配所述柱形管16;所述杯盖底座25设置于所述杯罩24远离所述扩展杯盖23的一侧,与所述储液杯1相适配,所述杯罩24和所述柱形管16适配后形成所述气流通道部12的外表面和所述流体通道部22的内表面之间的输送部以存储待雾化的药物喷剂。In some specific embodiments, as shown in FIG. 10 and FIG. 11 , 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 , and 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.
进一步,结合图10和图12所示,所述杯盖底座25还包括至少一个杯盖凹槽26,以在所述储液杯1与所述储液杯盖2的所述杯盖底座25之间形成液体流通通道,所述杯盖凹槽26用以使所述药物喷剂可以从所述储液杯1中流入所述气流通道部12的外表面和所述流体通道部22的内表面之间的输送部中。Further, as shown in FIG. 10 and FIG. 12 , 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.
可选的,结合图11、图12和图14所示,所述流体通道部22还包括回流部27,设置于所述流体通道部22的外侧面,所述回流部27包括延伸凹槽271和垂直沟槽272,所述垂直沟槽272从所述雾化喷嘴21处的外侧面缘延伸至所述杯罩24处,所述延伸凹槽271与所述杯罩24侧的所述垂直沟槽272的端部相连接,并垂直于所述流体通道部22的外侧面,所述回流部27用以引流掉落的药物喷剂。Optionally, as shown in FIG. 11 , FIG. 12 and FIG. 14 , 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.
进一步,结合图10和图11所示,所述回流部27的所述延伸凹槽271还设置至少一个回流孔(图中未示出),以将所述储液杯盖2的外部与所述储液杯1的内腔相连通,所述回流孔通过内外气压差将掉落的药物喷剂压回至所述存储部13,从而最大限度地减少药物喷剂的浪费。Further, as shown in FIG. 10 and FIG. 11 , 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.
参照图9和图10,本发明实施例二的所述鼻腔给药的喷雾装置还包括控制***,所述控制***包括鼻腔喷雾泵(图中未示出),与所述气流通道部 12连接,用以向所述鼻腔给药的喷雾装置提供气流。Referring to FIGS. 9 and 10 , the spray device for nasal administration according to the second embodiment of the present invention 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.
在一些实施例中,参照图4,所述驱动模块41用以向所述鼻腔喷雾泵(图中未示出)提供驱动力,所述监测模块42用以实时监测并记录所述驱动力的大小,所述记时模块43用以记录所述驱动模块41施加驱动力的上升时间、保持时间、下降时间和喷雾延迟时间。In some embodiments, referring to FIG. 4 , 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 .
在一些实施例中,如图4所示,本发明实施例二的所述控制***还包括主控部4,该主控部4与本发明实施例一的所述控制***的主控部4的结构和功能一致,均包括与所述主控部4通讯连接的驱动模块41、监测模块42和记时模块43,所述驱动模块41用以向所述鼻腔喷雾泵(图中未示出)提供驱动力,所述监测模块42用以实时监测并记录所述驱动力的大小,所述记时模块43用以记录所述驱动模块41施加驱动力的上升时间、保持时间、下降时间和喷雾延迟时间。In some embodiments, as shown in FIG. 4 , 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). ) to provide driving force, 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 rise time, hold time, fall time and Spray delay time.
结合图4、图9和图10所示,所述主控部4通信连接鼻腔喷雾泵(图中未示出),而所述鼻腔喷雾泵与所述气流通道部12连接,用以向所述鼻腔给药的喷雾装置提供气流。4, 9 and 10, 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.
在一些具体的实施例中,所述监控模块42实时监测和记录所述驱动力的大小,并将记录结果发送至所述主控部4,所述主控部4通过控制所述驱动模块41使所述驱动力的大小维持在设定值,以获得稳定的给药气流和气压。需要说明的使,所述驱动力设定值的范围在50-250KPa,根据鼻腔内病变部位的治疗效果进行调整。In some specific embodiments, 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.
进一步,所述控制***通过设定所述驱动力、所述驱动力的上升时间、保持时间和下降时间来控制所述供气气流和气压的大小,所述驱动力的上升 时间、保持时间和下降时间根据每次鼻腔病变部位的治疗情况进行调整。Further, the 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.
本发明还提供了一种给药***,包括实施例一和实施例二任意一种所述鼻腔给药的喷雾装置。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.
虽然在上文中详细说明了本发明的实施方式,但是对于本领域的技术人员来说显而易见的是,能够对这些实施方式进行各种修改和变化。但是,应理解,这种修改和变化都属于权利要求书中所述的本发明的范围和精神之内。而且,在此说明的本发明可有其它的实施方式,并且可通过多种方式实施或实现。Although the embodiments of the present invention have been described in detail above, it will be apparent to those skilled in the art that various modifications and changes can be made to these embodiments. However, it should be understood that such modifications and changes are within the scope and spirit of the invention as set forth in the appended claims. Furthermore, the invention described herein is capable of other embodiments and of being practiced or carried out in various ways.

Claims (24)

  1. 一种鼻腔给药的喷雾装置,其特征在于,包括:A spray device for nasal administration, comprising:
    储液杯,用以储存药物喷剂,所述储液杯包括出气孔和与所述出气孔相连通的气流通道部,所述出气孔的直径为0.35毫米-2.5毫米,所述气流通道部的高度为0.7-6.0毫米;The liquid storage cup is used to store the medicine spray. The liquid storage cup includes an air outlet hole and an air flow channel part communicated with the air outlet hole. The diameter of the air outlet hole is 0.35 mm to 2.5 mm. The height is 0.7-6.0 mm;
    储液杯盖,与所述储液杯适配,所述储液杯盖包括雾化喷嘴和与所述雾化喷嘴相连通的流体通道部,所述雾化喷嘴的直径为0.5毫米-3毫米;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, and the diameter of the atomizing nozzle is 0.5 mm-3 mm;
    所述流体通道部的直径大于所述气流通道部的直径,所述储液杯与所述储液杯盖适配后,所述气流通道部的外表面和所述流体通道部的内表面之间形成输送部,所述输送部的直径为0.002毫米-0.5毫米;The diameter of the fluid passage part is larger than the diameter of the air passage part, and after the liquid storage cup is fitted with the liquid storage cup cover, the outer surface of the air passage part and the inner surface of the fluid passage part are separated. A conveying part is formed between, and the diameter of the conveying part is 0.002 mm-0.5 mm;
    控制***,用以控制所述鼻腔给药的喷雾装置的给药气流和气压的大小维持在设定值;a control system, used to control the size of the drug gas flow and the air pressure of the spray device for nasal drug delivery to maintain a set value;
    双向气流插管,用以输送所述储液杯中的药物喷剂。A bidirectional airflow cannula is used to deliver the drug spray in the liquid storage cup.
  2. 如权利要求1所述的鼻腔给药的喷雾装置,其特征在于,所述储液杯包括圆柱形基体、排放管和底部杯壁,所述圆柱形基体、所述排放管、所述底部杯壁与所述气流通道部共同构成药剂的储存空间,所述排放管设置于所述圆柱形基体的侧壁上,所述底部杯壁连接所述气流通道部与所述圆柱形基体。The spray device for nasal administration according to claim 1, wherein the liquid storage cup comprises a cylindrical base body, a discharge pipe and a bottom cup wall, the cylindrical base body, the discharge pipe and the bottom cup The wall and the air flow channel part together form a storage space for medicine, the discharge pipe is arranged on the side wall of the cylindrical base body, and the bottom cup wall connects the air flow channel part and the cylindrical base body.
  3. 如权利要求2所述的鼻腔给药的喷雾装置,其特征在于,所述底部杯壁包括对称设置的凹陷部,所述凹陷部设置于靠近所述流体通道的一侧。The spray device for nasal administration according to claim 2, wherein the bottom cup wall comprises a symmetrically arranged concave portion, and the concave portion is disposed on a side close to the fluid channel.
  4. 如权利要求2所述的鼻腔给药的喷雾装置,其特征在于,所述圆柱形基体、所述底部杯壁、所述气流通道部与所述排放管为一体式结构。The spray device for nasal administration according to claim 2, wherein the cylindrical base body, the bottom cup wall, the airflow channel part and the discharge pipe are integral structures.
  5. 如权利要求2所述的鼻腔给药的喷雾装置,其特征在于,所述储液杯还包括储液杯盖连接部,设置于所述圆柱形基体远离所述底部杯壁的一侧。The spray device for nasal administration according to claim 2, characterized in that, the liquid storage cup further comprises a liquid storage cup cover connecting part, which is arranged on the side of the cylindrical base body away from the bottom cup wall.
  6. 如权利要求5所述的鼻腔给药的喷雾装置,其特征在于,所述储液杯盖包括与所述圆柱形基体适配的喷射室外壁和与所述储液杯盖连接部适配的连接内壁,所述喷射室外壁、所述连接内壁、所述雾化喷嘴和所述流体通道部共同构成气体喷射室。The spray device for nasal administration according to claim 5, wherein the liquid storage cup cover comprises a spraying chamber wall adapted to the cylindrical base body and a spraying chamber wall adapted to the connection part of the liquid storage cup cap The connecting inner wall, the spraying outer wall, the connecting inner wall, the atomizing nozzle and the fluid channel part together constitute a gas spraying chamber.
  7. 如权利要求6所述的鼻腔给药的喷雾装置,其特征在于,所述储液杯盖还包括固定部,所述固定部设置于所述储液杯盖的中心轴线处,以可拆卸连接所述储液杯与所述储液杯盖。The spray device for nasal administration according to claim 6, wherein the liquid storage cup cover further comprises a fixing portion, and the fixing portion is disposed at the central axis of the liquid storage cup cover and is detachably connected The liquid storage cup and the liquid storage cup cover.
  8. 如权利要求6所述的鼻腔给药的喷雾装置,其特征在于,所述储液杯盖还包括适配于所述雾化喷嘴的气体控制器,所述气体控制器设置于所述雾化喷嘴远离所述流体通道部的一侧,并与所述喷射室外壁相连接。The spray device for nasal administration according to claim 6, wherein the liquid storage cup cover further comprises a gas controller adapted to the atomizing nozzle, and the gas controller is arranged on the atomizing nozzle. The nozzle is away from the side of the fluid passage portion and is connected with the outer wall of the ejection chamber.
  9. 如权利要求6所述的鼻腔给药的喷雾装置,其特征在于,所述流体通道部内侧设有至少一个内置沟槽。The spray device for nasal administration according to claim 6, wherein at least one built-in groove is provided inside the fluid channel portion.
  10. 如权利要求1所述的鼻腔给药的喷雾装置,其特征在于,所述储液杯还包括存储部、液体杯座和支撑部,所述液体杯座与所述存储部的底部相连接,形成药物喷剂的存储空间,所述支撑部与所述液体杯座相连接,并设置在所述液体杯座远离所述出气孔的一侧。The spray device for nasal administration according to claim 1, wherein the liquid storage cup further comprises a storage part, a liquid cup base and a support part, and the liquid cup base is connected with the bottom of the storage part, A storage space for medicinal spray is formed, and the support portion is connected with the liquid cup holder and is arranged on the side of the liquid cup holder away from the air outlet.
  11. 如权利要求10所述的鼻腔给药的喷雾装置,其特征在于,所述储液杯包括与所述气流通道部连通的柱形管,所述柱形管与所述液体杯座适配,并设置于所述存储部的内侧。The spray device for nasal administration according to claim 10, wherein the liquid storage cup comprises a cylindrical tube communicated with the air flow channel portion, and the cylindrical tube is adapted to the liquid cup seat, and arranged inside the storage part.
  12. 如权利要求11所述的鼻腔给药的喷雾装置,其特征在于,所述柱形 管还包括进气***口,所述进气***口与所述气流通道部连通设置。The spray device for nasal administration according to claim 11, wherein the cylindrical tube further comprises an air inlet insertion port, and the air inlet insertion port is arranged in communication with the air flow passage portion.
  13. 如权利要求10所述的鼻腔给药的喷雾装置,其特征在于,所述储液杯还包括至少一个水平标记或至少一个标线,以指示液位。The spray device for nasal administration of claim 10, wherein the liquid storage cup further comprises at least one horizontal mark or at least one reticle to indicate the liquid level.
  14. 如权利要求11所述的鼻腔给药的喷雾装置,其特征在于,所述储液杯盖包括扩展杯盖、杯罩、杯盖底座,所述扩展杯盖设置于所述流体通道部与所述杯罩之间,并沿所述储液杯盖远离轴线方向凸出,以适配所述存储部,所述杯罩设置于所述扩展杯盖与所述杯盖底座之间,以适配所述柱形管,所述杯盖底座设置于所述杯罩远离所述扩展杯盖的一侧,与所述储液杯相适配。The spray device for nasal administration according to claim 11, wherein the liquid storage cup cover comprises an expansion cup cover, a cup cover, and a cup cover base, and the expansion cup cover is disposed between the fluid channel portion and the between the cup covers, and project along the direction of the liquid storage cup cover away from the axis to fit the storage part, the cup cover is arranged between the expansion cup cover and the cup cover base to fit the storage part. Equipped with the cylindrical tube, the cup cover base is arranged on the side of the cup cover away from the expansion cup cover, and is matched with the liquid storage cup.
  15. 如权利要求14所述的鼻腔给药的喷雾装置,其特征在于,所述杯盖底座还包括至少一个杯盖凹槽,以在所述储液杯与所述杯盖底座之间形成液体流通通道。The spray device for nasal administration of claim 14, wherein the cup cover base further comprises at least one cup cover groove to form liquid communication between the liquid storage cup and the cup cover base aisle.
  16. 如权利要求15所述的鼻腔给药的喷雾装置,其特征在于,所述流体通道部还包括设置于所述流体通道部的外侧面的回流部,所述回流部包括延伸凹槽和垂直沟槽,所述垂直沟槽从所述雾化喷嘴处的外侧面缘延伸至所述杯罩处,所述延伸凹槽与所述杯罩侧的所述垂直沟槽的端部相连接,并垂直于所述流体通道部的外侧面。The spray device for nasal administration according to claim 15, wherein the fluid channel portion further comprises a backflow portion disposed on the outer side of the fluid channel portion, the backflow portion comprising an extension groove and a vertical groove a groove, the vertical groove extends from the outer edge of the atomizing nozzle to the cup cover, the extending groove is connected with the end of the vertical groove on the cup cover side, and perpendicular to the outer side surface of the fluid channel portion.
  17. 如权利要求16所述的鼻腔给药的喷雾装置,其特征在于,所述回流部还包括至少一个回流孔,以将所述储液杯盖的外部与所述储液杯的内腔相连通。The spray device for nasal administration according to claim 16, wherein the return part further comprises at least one return hole to communicate the outside of the liquid storage cup cover with the inner cavity of the liquid storage cup .
  18. 如权利要求2或10所述的鼻腔给药的喷雾装置,其特征在于,所述控制***包括鼻腔喷雾泵,与所述气流通道部连接,用以向所述鼻腔给药的 喷雾装置提供气流。The spray device for nasal administration according to claim 2 or 10, wherein the control system comprises a nasal spray pump, which is connected to the air flow channel part, and is used for providing air flow to the spray device for nasal administration .
  19. 如权利要求18所述的鼻腔给药的喷雾装置,其特征在于,所述控制***还包括主控部,所述主控部通信连接所述鼻腔喷雾泵,以控制供气气流和气压。The spray device for nasal administration according to claim 18, wherein the control system further comprises a main control part, the main control part is communicatively connected to the nasal spray pump to control the supply air flow and air pressure.
  20. 如权利要求19所述的鼻腔给药的喷雾装置,其特征在于,所述主控部包括与所述主控部通讯连接的驱动模块、监测模块和记时模块,所述驱动模块用以向所述鼻腔喷雾泵提供驱动力,所述监测模块用以实时监测并记录所述驱动力的大小,所述记时模块用以记录所述驱动模块施加驱动力的上升时间、保持时间、下降时间和喷雾延迟时间。The spray device for nasal administration of claim 19, wherein the main control part comprises 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 send The nasal spray pump provides driving force, the monitoring module is used to monitor and record the magnitude of the driving force in real time, and the timing module is used to record the rise time, hold time, and fall time of the driving force applied by the driving module and spray delay time.
  21. 如权利要求2所述的鼻腔给药的喷雾装置,其特征在于,所述双向气流插管包括气凝胶输送管和加压空气输送管,所述气凝胶输送管用以将药物喷剂输送到第一个鼻腔的病变部位,所述加压空气输送管用以将加压空气输送入第二个鼻腔来封闭鼻腔呼吸***。The spray device for nasal administration of claim 2, wherein the bidirectional airflow cannula comprises an aerogel delivery tube and a pressurized air delivery tube, and the aerogel delivery tube is used to deliver the drug spray To the lesion site of the first nasal cavity, the pressurized air delivery tube is used to deliver pressurized air into the second nasal cavity to close the nasal respiratory system.
  22. 如权利要求21所述的鼻腔给药的喷雾装置,其特征在于,所述气凝胶输送管包括气凝胶出口、气凝胶软管接口和气凝胶插管连接处外壁,所述气凝胶出口和所述气凝胶软管接口设置在所述气凝胶输送管的两端,所述气凝胶插管连接处外壁适配于所述排放管,所述气凝胶出口设置在所述气凝胶输送管远离所述气凝胶插管连接处外壁的一侧。The spray device for nasal administration according to claim 21, wherein the aerogel delivery tube comprises an aerogel outlet, an aerogel hose interface and an outer wall of the connection of the aerogel cannula, and the aerogel The glue outlet and the aerogel hose interface are arranged at both ends of the aerogel delivery tube, the outer wall of the aerogel cannula connection is adapted to the discharge tube, and the aerogel outlet is arranged at the The side of the aerogel delivery tube away from the outer wall of the aerogel cannula connection.
  23. 如权利要求22所述的鼻腔给药的喷雾装置,其特征在于,所述加压空气输送管包括加压空气出口和加压空气***口,所述加压空气出口和所述加压空气***口设置在所述加压空气输送管的两端,所述加压空气出口设置在靠近所述气凝胶出口的一侧。The spray device for nasal administration of claim 22, wherein the pressurized air delivery tube comprises a pressurized air outlet and a pressurized air insertion port, the pressurized air outlet and the pressurized air insertion port Ports are provided at both ends of the pressurized air delivery pipe, and the pressurized air outlet is provided on a side close to the aerogel outlet.
  24. 一种给药***,其特征在于,包括权利要求1-23任一项所述的鼻腔给药的喷雾装置。A drug delivery system, characterized in that it comprises the spray device for nasal administration according to any one of claims 1-23.
PCT/CN2022/079836 2021-03-23 2022-03-09 Spraying device for nasal administration and administration system WO2022199379A1 (en)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
CN202120587738.8U CN214911992U (en) 2021-03-23 2021-03-23 Nasal spray atomizer
CN202120587738.8 2021-03-23
CN202110314650.3A CN112957572A (en) 2021-03-24 2021-03-24 Nasal cavity administration spraying device and administration system
CN202110314650.3 2021-03-24

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WO2022199379A1 true WO2022199379A1 (en) 2022-09-29

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Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102753228A (en) * 2009-12-08 2012-10-24 美德英文特有限公司 Method for nasal irrigation and drug delivery
CN104001244A (en) * 2014-05-20 2014-08-27 江苏康诺医疗器械有限公司 Multi-functional spray can
CN104159632A (en) * 2012-03-07 2014-11-19 美德英文特有限公司 Portable nebulizer device
WO2019049178A1 (en) * 2017-09-06 2019-03-14 3A Health Care S.R.L. Aerosol therapy device
US20200001024A1 (en) * 2018-06-28 2020-01-02 Yi-Jin Promold Enterprise Ltd. Liquid atomizing device
CN112957572A (en) * 2021-03-24 2021-06-15 合肥启灏医疗科技有限公司 Nasal cavity administration spraying device and administration system
CN214911992U (en) * 2021-03-23 2021-11-30 合肥启灏医疗科技有限公司 Nasal spray atomizer

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102753228A (en) * 2009-12-08 2012-10-24 美德英文特有限公司 Method for nasal irrigation and drug delivery
CN104159632A (en) * 2012-03-07 2014-11-19 美德英文特有限公司 Portable nebulizer device
CN104001244A (en) * 2014-05-20 2014-08-27 江苏康诺医疗器械有限公司 Multi-functional spray can
WO2019049178A1 (en) * 2017-09-06 2019-03-14 3A Health Care S.R.L. Aerosol therapy device
US20200001024A1 (en) * 2018-06-28 2020-01-02 Yi-Jin Promold Enterprise Ltd. Liquid atomizing device
CN214911992U (en) * 2021-03-23 2021-11-30 合肥启灏医疗科技有限公司 Nasal spray atomizer
CN112957572A (en) * 2021-03-24 2021-06-15 合肥启灏医疗科技有限公司 Nasal cavity administration spraying device and administration system

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