CN114470442A - Pen-shaped drug delivery device for aerosol inhalation - Google Patents

Abstract

The invention discloses a pen-type drug delivery device that can be used for atomization inhalation, comprising a quantitative drug delivery control device, a medicine storage bottle fixing device and an atomizing device. The pen-type nebulizer can be used to generate a mist of medicine, which can be inhaled by a subject to achieve effects such as treatment or immunity. Vaccines are directly filled into cartridges and used with dispenser pens, which replaces the extraction step of injecting vaccines in syringes, reduces the workload of vaccinators, and avoids the risk of injury caused by puncturing the rubber stopper with a syringe to draw medicine. The dispensing needle punctures the cartridge once, reducing the puncture debris caused by using the syringe to draw medicine multiple times. Pen nebulizers reduce liquid waste and facilitate transportation by accurately dispensing liquids.

Description

A pen-type drug delivery device that can be used for atomization inhalation

technical field

The present invention relates to an atomization drug delivery device, in particular to a pen-type drug delivery device that can be used for atomization inhalation.

Background technique

Today, with the increasingly serious air pollution, coupled with the sudden cold and warm weather during the season change, the number of patients with respiratory diseases has greatly increased. Aerosol inhalation drug delivery can greatly reduce respiratory problems. The existing atomizing drug delivery devices in the prior art mainly adopt the method of inhaling while atomizing, and it is necessary to guide the subjects before administration. Children and even many adults often suffer from inhalation and self-breathing. Improper frequency control greatly affects the inhalation and absorption of drug mist, which is very unfavorable for immunization or disease treatment. In addition, there is a risk of cross-infection when inhaling while fogging. The invention relates to a pen-type atomizer, which can atomize medicinal liquid into a cup in advance and then inhale into the body, which can not only prevent cross-infection, but also reduce costs, and has high inhalation and inoculation efficiency. At present, a treatment method for respiratory diseases is atomization inhalation, which uses a nebulizer to disperse the medicinal liquid into fine droplets, which are inhaled through the patient's nose or mouth. Increase the local concentration of the drug to achieve a therapeutic effect. Atomization inhalation has a very good therapeutic effect on bronchiolitis, asthmatic bronchitis, bronchial asthma, acute and chronic bronchitis, acute laryngitis, and acute pneumonia.

Aerosol inhalation vaccine is a vaccine that is immunized by aerosol inhalation. The so-called aerosol inhalation immunity means that the vaccine is atomized into tiny particles by a nebulizer. immunity.

The equipment and devices that realize such aerosol inhalation therapy and immunization are very important for the implementation and quality of therapy and immunization, and have received great attention from researchers. The existing atomizing drug delivery devices in the prior art mainly adopt the method of inhaling while atomizing, and it is necessary to guide the subjects before administration. Children and even many adults often suffer from inhalation and self-breathing. Improper frequency control greatly affects the inhalation and absorption of drug mist, which is very unfavorable for immunization. In addition, for immunization, to prevent cross-infection, the part of the device for inhalation by subjects should be sterilized or discarded after use. In view of the necessity of large-scale inoculation, it is an urgent problem to provide an aerosol drug delivery device that can prevent cross-infection while reducing costs and having high inhalation inoculation efficiency.

SUMMARY OF THE INVENTION

In order to overcome the deficiencies of the prior art, the present invention provides a pen-type atomizer, which can be used to generate a drug mist that can be inhaled by a subject to achieve effects such as treatment or immunity.

Vaccines do not need injections, but only need to inhale the vaccine into the respiratory tract and lungs through a pen-type nebulizer, so as to obtain the "triple protection" of mucosal immunity, cellular immunity and humoral immunity. Compared with the cellular immunity and humoral immunity formed by the injectable new crown vaccine, the aerosol inhalation vaccine can induce the human body to produce mucosal immunity, preventing infection and blocking transmission at the first pass of virus invasion.

Using the pen-shaped drug delivery device of the present invention, the vaccine for atomization inhalation can be inoculated with only one inhalation, which is safer and more convenient, and is suitable for popularization and use in large-scale population. At the same time, a dose of aerosol inhalation vaccine only needs one-fifth of the dose of intramuscular injection, and the level of cellular immune response generated is comparable to that of intramuscular injection, which means that the production capacity is indirectly increased by five times.

The purpose of the present invention is to solve the problems of cross-infection, high cost and low efficiency in the existing atomizing device while inhaling mist. Provided is a pen-shaped atomizing drug delivery device. When medicine is needed, the medicinal liquid can be atomized into a cup in advance and then inhaled into the body to achieve the purpose of treatment or immunization.

To achieve the above object, the present invention adopts the technical scheme as follows:

The inhalable pen-type aerosol drug delivery device includes a metered dose control device, a drug storage bottle fixing device and an atomizing device.

The dosing control device includes a push button, a sleeve push rod, a rack, a housing, a return spring, a first spring limiting part, a rack locator, a step displacement slot, a second spring limiting part, a tooth A step-by-step pushing member, a step-by-step limit rod, and a step-by-step push head is arranged at the lower end of the rack.

Specifically, the first spring limiting member and the second spring limiting member are disposed on the inner walls of both sides of the housing for fixing the return spring.

Specifically, the rack locator is located at the end of the rack, and is used to fix the rack when the telescopic push rod is reset.

Specifically, the step limit rod is located in the step displacement slot and can move in the step displacement slot.

The medicine storage bottle fixing device can fix the medicine storage bottle prefilled with the medicine liquid, and the medicine storage bottle can be a cartridge bottle or a vial.

Specifically, the front end of the medicine storage bottle fixing device is provided with a liquid outlet needle; the liquid outlet needle communicates the medicine storage bottle with the atomizing device; the medicine storage bottle fixing device and the atomizing device are connected by a double nut structure.

The atomization device includes a liquid storage tank, a vibrating mesh screen, a mist outlet, and an electrical signal control plug. The vibrating mesh screen is located at the open end of the liquid storage tank and communicated with the mist outlet.

Specifically, when the push button is pressed, the sleeve-type push rod moves downward, the rack stepping pushing part pushes the rack to move downward, and the stepping pusher at the end of the rack pushes the medicine storage bottle glue in the medicine storage bottle fixing device plug, the liquid in the medicine storage bottle is added to the liquid storage tank of the atomizer through the needle; release the button, the reset spring pushes the sleeve push rod back to reset.

Specifically, the vibrating mesh screen type atomizer of the atomization device, the vibrating mesh screen is made of metal material or thin film polymer material, preferably the metal material is stainless steel or alloy; Styrene, polyimide; the more preferred vibrating mesh screen is palladium alloy material.

Because the piezoelectric ceramic element of the vibrating mesh screen is laminated with the vibrating mesh screen of metal material or thin-film polymer material, the piezoelectric ceramic element receives the high-frequency electrical signal from the circuit of the electrical signal control plug through two external wires. Then the electrical signal can be converted into high-frequency vibration, and the high-frequency vibration is transmitted to the liquid, causing the liquid surface of the liquid to bulge, and cavitation around the bulge. It vibrates repeatedly to generate surface tension waves with limited amplitude on the liquid surface. The wave head of this wave is dispersed to atomize the liquid medicine. The atomized particles pass through the small hole (Φ1μm) in the center of the metal material or thin-film polymer material sheet by gravity. ~5μm), enter the atomizing cup to achieve the purpose of atomization.

Beneficial technical effects:

1. The pen-type atomizing drug delivery device can be used to generate a drug mist for inhalation by a subject to achieve effects such as treatment or immunity.

2. The vaccine can be directly filled into a cartridge and used with a dispenser pen, which replaces the liquid extraction step of the syringe loaded with the vaccine, reduces the workload of the vaccinators, and avoids the risk of injury caused by puncturing the rubber stopper with a syringe. .

3. The dispensing needle punctures the cartridge once, which reduces the puncture debris caused by using the syringe to draw medicine multiple times.

4. The pen-type atomizing drug delivery device can reduce the waste of liquid medicine and facilitate transportation through accurate liquid dispensing.

Description of drawings

1 is a schematic structural diagram of a device provided by the present invention that can be used for aerosol inhalation administration;

Fig. 2 is the exploded structure schematic diagram of the device that can be used for atomization inhalation administration provided by the present invention;

3 is a schematic cross-sectional structure diagram of a metered drug administration control device of the device provided by the present invention that can be used for aerosol inhalation drug delivery;

4 is a schematic cross-sectional structure diagram of a medicine storage assembly of the device provided by the present invention that can be used for atomization inhalation drug delivery;

5 is a schematic cross-sectional structural diagram of a bolus component of the device provided by the present invention that can be used for aerosol inhalation drug delivery;

6 is a schematic cross-sectional structure diagram of a double nut and a liquid outlet needle of the atomized inhalation drug delivery device provided by the present invention;

7 is a schematic cross-sectional structure diagram of the atomization inhalation drug delivery device provided by the present invention;

8 is a schematic structural diagram of the vibrating mesh screen type atomizer of the atomizing inhalation drug delivery device provided by the present invention;

Fig. 9 is the structural representation of the atomizing cup of the present invention;

The accompanying figures are marked as follows:

Push button 1, sleeve push rod 2, rack 3, housing 4, return spring 5, first spring limiting member 6, rack positioner 7, step displacement slot 8, second spring limiting member 9, Rack stepping push member 10, stepping limit rod 11, stepping pusher 12, medicine storage bottle rubber stopper 13, medicine storage bottle 14, liquid outlet needle 15, liquid storage tank 16, atomization device 17, mist outlet Port 18, electrical signal control plug 19, medicine storage bottle fixing device 20, double nut structure 21, piezoelectric ceramic element 22, vibrating mesh screen 23, card slot 24, protrusion 25, cup body 26, cup cover 27, inlet Mist mouth 28, suction nozzle 29.

Detailed ways

Unless otherwise defined, all scientific and technical terms used in the present invention have the same meaning as commonly understood by one of ordinary skill in the art to which this invention relates.

Various publications, patents, and published patent specifications are cited herein, the disclosures of which are incorporated by reference in their entirety.

The technical solutions of the present invention will be clearly and completely described below with reference to the embodiments of the present invention. Obviously, the described embodiments are only a part of the embodiments of the present invention, rather than all the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those of ordinary skill in the art without creative efforts shall fall within the protection scope of the present invention.

Example 1 As shown in FIG. 1 , an atomized inhalation drug delivery device includes a dosing control device, a medicine storage bottle fixing device and an atomizing device.

The dosing control device includes a push button 1, a sleeve push rod 2, a rack 3, a housing 4, a return spring 5, a first spring limiting member 6, a rack locator 7, and a step displacement slot 8, The second spring limiting member 9 , the rack stepping pushing member 10 , the stepping limiting rod 11 , and the lower end of the rack 3 is provided with a stepping pusher 12 .

The first spring limiting member 6 and the second spring limiting member 9 are disposed on the inner walls on both sides of the housing 4 for fixing the return spring 5 .

The rack locator 7 is located at the end of the rack 3 and is used to fix the rack 3 when the sleeve push rod 2 is reset.

The step limit rod 11 is located in the step displacement slot 8 and can move in the step displacement slot 8 .

The medicine storage bottle fixing device 20 can fix the medicine storage bottle 14 prefilled with the medicine liquid, and the medicine storage bottle can be a cartridge bottle or a vial.

The front end of the medicine storage bottle fixing device 20 is provided with a liquid outlet needle 15 ; the liquid outlet needle communicates the medicine storage bottle 14 with the atomizing device.

The atomizing device 17 includes a liquid storage tank 16, a vibrating mesh screen 23, a mist outlet 18, and an electrical signal control plug 19. The vibrating mesh screen 23 is located at the open end of the liquid storage tank 16 and is connected to the mist outlet 18. Connected.

The atomizing cup is composed of a cup body 26 and a cup cover 27, and the mist outlet 18 is docked with the mist inlet 28 of the atomizing cup. A suction nozzle 29 is provided on the top of the cup cover 27 near the edge. Through the suction nozzle 29, the patient can inhale the mist of medicinal liquid into the respiratory tract and lungs through the mouth to achieve a therapeutic effect.

Press the push button 1, the sleeve push rod 2 moves down, the rack stepping pusher 10 pushes the rack 3 to move down, and the stepping pusher 12 at the end of the rack pushes the storage bottle in the medicine storage bottle fixing device 20. The medicine bottle rubber stopper 13, the medicine liquid in the medicine storage bottle is added into the liquid storage tank 16 of the atomizer through the needle; release the push button 1, the reset spring 5 pushes the sleeve push rod 2 back to reset.

The atomizing device 17 is a vibrating mesh type atomizer. The vibrating mesh type atomizer is formed by laminating the piezoelectric ceramic element 22 and the vibrating mesh screen 23. The electrical signal controls the plug 19 and the pressure that causes the diaphragm to vibrate. Electrical ceramic components are connected.

The vibrating mesh screen is made of metal material or film polymer material, preferably the metal material is stainless steel,

Alloy; preferably the film polymer material is (PP) polypropylene, (PS) polystyrene, (PI) polyimide.

The bottom of the bolus injection assembly is provided with a clamping groove 24, and the medicine storage bottle fixing device 20 is connected with the clamping groove 24 of the bolus injection assembly through a protrusion 25 at the top.

Example 2 Written test of nebulizer dosing accuracy test

Select the atomization inhalation drug delivery device of Example 1, without connecting the atomizer, take 3 cartridges (3ml in size), fill the cartridges with purified water and then assemble them into the atomizer pen, and press for liquid separation , collect the liquid that is dispensed each time, and accurately weigh it with a ten-thousandth balance. The results are as follows:

The results show that the relative error of the liquid dispensing of the atomizing pen is within the range of ±2%, the dispensing accuracy is high, and the target use requirements can be met; the repeatability is less than 2%, the liquid dispensing accuracy is high, and the target use requirements can be met.

Embodiment 3 Screening of mesh material suitable for atomizing pen

Experimental group: respectively select vibrating mesh screens made of palladium alloy, stainless steel and polyimide materials, and assemble them into the atomizer.

Model drug: liquid formulation of recombinant novel coronavirus vaccine (type 5 adenovirus vector)

Take the cartridge filled with the vaccine and assemble it to the nebulizer pen, link the nebulizer pen and the nebulizer. Each group was nebulized three times, and the generated aerosol was tested by an inhalation preparation strength detector (Sympatech GmbH, with a gas flow rate of 15 L/min for equipment calibration), and the time required for nebulizing 0.1 ml of the vaccine was recorded.

the result shows:

From the results of particle size distribution, the median particle size of palladium alloy, stainless steel and polyimide materials can be selected as vibrating mesh screen, palladium alloy mesh screen atomizer pen and polyimide material mesh screen atomizer pen. The diameter and particle size distribution range are smaller than the stainless steel mesh screen.

The atomization time of the polyimide material mesh screen atomization pen is higher than that of the palladium alloy material mesh screen and the stainless steel mesh screen atomization pen. The reason may be that polymer materials are less rigid than metal materials and are more sensitive to the viscosity of liquid medicine.

Mist with a particle size of 1 to 5 μm can achieve a wide distribution in the lower respiratory tract, and when used with a nebulizer cup, a long nebulization time will lead to drug deposition.

According to actual needs, the diameter of metal material or film polymer material can be 5-20mm, and the central diameter is 2-8mm convex surface, and the convex surface faces the atomizing cup.

To sum up, the more suitable vibration mesh material for the recombinant new coronavirus vaccine (type 5 adenovirus vector) is palladium alloy.

The above descriptions are only preferred embodiments of the present invention, and are not intended to limit the present invention. Any modifications, equivalent replacements, etc. made within the spirit and principles of the present invention shall be included in the protection scope of the present invention. within.

The foregoing embodiments and methods described in this disclosure may vary based on the capabilities, experience, and preferences of those skilled in the art.

Only listing the steps of the method in a certain order in the present invention does not constitute any limitation on the order of the method steps.

Claims (10)

1. A pen-type drug delivery device for aerosol inhalation is characterized by comprising a quantitative drug delivery control device, a drug storage bottle fixing device and an atomization device.

2. The pen type drug delivery device for aerosol inhalation according to claim 1, wherein the dosing control device comprises a pressing button (1), a sleeve-type push rod (2), a rack (3), a housing (4), a return spring (5), a first spring limiting component (6), a rack positioner (7), a stepping displacement groove (8), a second spring limiting component (9), a rack stepping pushing component (10), and a stepping limiting rod (11), wherein a stepping pushing head (12) is arranged at the lower end of the rack (3).

3. The pen delivery device for aerosol inhalation according to claim 2, characterized in that the first spring stop (6) and the second spring stop (9) are arranged on the inner walls of the housing (4) on both sides for fixing the return spring (5).

4. A pen delivery device for aerosol inhalation according to any of claims 2 to 3, wherein a rack retainer (7) is located at the end of the rack (3) for securing the rack (3) when the telescopic plunger (2) is reset.

5. Pen type delivery device for aerosol inhalation according to any of claims 2 to 4, characterized in that the step limiter lever (11) is located in the step displacement slot (8) and is movable in the step displacement slot (8).

6. Pen-type drug delivery device for aerosol inhalation according to one of claims 2 to 5, characterized in that the drug reservoir holder (20) holds a drug reservoir (14) of a pre-filled drug solution, which is selected from a cassette or a vial of penicillin.

7. The pen type drug delivery device for aerosol inhalation according to any one of claims 2 to 6, wherein the front end of the drug storage bottle holder (20) is provided with a liquid discharge needle (15); the liquid outlet needle is used for communicating the medicine storage bottle (14) with the atomizing device (17), and preferably, the medicine storage bottle fixing device (20) is connected with the atomizing device through a double-nut structure (21).

8. A pen delivery device for aerosol inhalation according to any of claims 2 to 7, wherein the aerosolization device (17) comprises a reservoir (16), a vibrating mesh screen (23), an aerosol outlet (18), an electrical signal control plug (19), the vibrating mesh screen (23) being located at an open end of the reservoir (16) and communicating with the aerosol outlet (18).

9. The pen-type drug delivery device for aerosol inhalation according to any one of claims 2 to 8, wherein the push button (1) is pressed, the sleeve-type push rod (2) moves downwards, the rack stepping pushing member (10) pushes the rack (3) to move downwards, the stepping pushing head (12) at the tail end of the rack pushes the drug storage bottle rubber plug (13) in the drug storage bottle fixing device (20), and the drug solution in the drug storage bottle is added into the atomizer reservoir (16) through the needle; the pressing button (1) is released, and the return spring (5) reversely pushes the sleeve type push rod (2) to return.

10. A pen delivery device for aerosol inhalation according to any of claims 2 to 9, wherein the aerosolization device is a vibrating mesh screen nebulizer, formed by attaching a piezo-ceramic element (22) and a vibrating mesh screen sheet (23).

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