A single dose disposable powder aerosol device

Abstract

A single dose disposable powder aerosol device belongs to the field of medical devices. It is composed of a bottom cover, a suction nozzle and a sliding cover. The suction nozzle and the sliding cover are assembled on one side of the bottom cover. The suction nozzle is assembled on the front half of the bottom cover, and the sliding cover is assembled on the rear half of the bottom cover. An air inlet, a medicine pit, a medicine inlet channel and a vortex cavity are sequentially arranged on the bottom cover. At least one side air inlet is arranged on the side of the vortex cavity. An ascending air duct and a medicine outlet are sequentially arranged in the suction nozzle body. After the bottom cover, the suction nozzle and the sliding cover are assembled into one, the air inlet, the medicine pit, the medicine inlet channel, the vortex cavity, the ascending air duct and the medicine outlet form a complete flow channel cavity. The filling operation of the medicine powder in the medicine pit is realized through three steps of sliding the sliding cover, loading the medicine powder and closing the sliding cover. The sliding cover structure is adopted, which is convenient for the filling operation or supplement of the built-in medicine powder, and can be switched between disposable and reusable types. It can be widely used in the design and manufacture field of inhalation type drug delivery devices.

Description

Technical Field

[0001] This invention belongs to the field of medical devices, and in particular relates to an inhalation-type drug delivery device for delivering drugs into or onto the human body. Background Technology

[0002] Lung administration (or inhalation administration) has become the preferred treatment for asthma and chronic obstructive pulmonary disease due to its advantages such as rapid onset of action, low toxicity and side effects, and absence of first-pass effect in the liver.

[0003] Among the many dosage forms of inhaled medications, powder inhalers have the following advantages compared to other dosage forms (such as aerosols, nebulized inhalation solutions, and nebulized inhalation suspensions):

[0004] 1) Contains no propellants, making it environmentally friendly;

[0005] 2) Small size, easy for patients to carry and use;

[0006] 3) Advantages and characteristics such as relatively less drug waste.

[0007] Therefore, powder inhalers have gradually become a research focus for some international pharmaceutical companies and research institutions that study inhalation formulations.

[0008] Compared to traditional powder inhalers (such as capsule powder inhalers, vesicle powder inhalers, and reservoir powder inhalers), single-dose disposable powder inhalers are characterized by the fact that the device is discarded after the patient finishes using the single dose of medication. Generally speaking, the internal structure of these devices is simpler (compared to capsule, reservoir, and vesicle devices), and the manufacturing cost is lower.

[0009] Currently, these devices are being used to deliver vaccines and other large molecule drugs. Traditional vaccine administration involves injection, which carries the risk of needle infection (especially in underdeveloped regions). Inhalation administration not only avoids this risk but also allows the drug to take effect more quickly.

[0010] Currently, there is relatively little design and research on disposable powder aerosol sprayers in China, while many such products (devices) have already emerged abroad. In 2010, Hovione developed... As a drug delivery device, the product It was listed in Japan. Therefore, It became the first commercially approved disposable powder spray device product.

[0011] The device accelerates the airflow through a narrow air inlet, intensifying turbulence within the flow channel and accelerating collisions between particles and the device walls. This results in relatively high flow resistance during drug dispersion, which may make drug inhalation difficult for patients, negatively impacting their inhalation experience, reducing medication adherence, and ultimately affecting the treatment outcome. Furthermore... The powder in the device is filled into the device's movable medicine chamber, which has through holes at both the top and bottom. In the industrial production process, special filling equipment is required for filling, and the production cost of the product is higher than that of general-purpose filling equipment.

[0012] Compared to Another disposable powder inhaler, Cyclops, has lower flow resistance when inhaling medication. However, the Cyclops device has three parts. During filling, the powder must first be filled into the aluminum foil blister pack, then the aluminum foil blister pack must be installed in the corresponding position, and then the three parts must be installed. This is still inconvenient in the filling process of industrial production and is not suitable for the early development of inhalation products that require adjustment of powder inhalers. Summary of the Invention

[0013] The technical problem to be solved by this invention is to provide a single-dose disposable powder inhaler device. It adopts a modular structural design with a sliding cover, facilitating the filling of internal drug powder. While maintaining the main flow channel structure unchanged, the device can be switched between single-use and reusable types to meet different prescription requirements. The device itself has a simple structure, with the number of parts reduced to a minimum (only 3 components), resulting in relatively low manufacturing costs.

[0014] The technical solution of the present invention is: to provide a single-dose disposable powder aerosol device, characterized in that:

[0015] The powder atomizer device consists of three parts: a bottom cover, a nozzle, and a sliding cover.

[0016] The suction nozzle and the sliding cover are respectively assembled on one side of the bottom cover;

[0017] The suction nozzle is mounted on the front half of the bottom cover; the sliding cover is mounted on the rear half of the bottom cover.

[0018] On the bottom cover, along the longitudinal axis of the bottom cover, there are sequentially connected air inlet, medicine pit, medicine inlet channel and vortex cavity.

[0019] At least one side air inlet is provided on the side of the vortex cavity;

[0020] In the body of the suction nozzle, an ascending air passage and a drug outlet are arranged sequentially along the longitudinal axis of the suction nozzle.

[0021] Below the sliding cover, there is a curved protrusion for guiding the airflow from the air inlet into the medicine pit, so as to help remove the medicine powder in the medicine pit.

[0022] After the bottom cover, nozzle and sliding cover are assembled into one unit, the air inlet, medicine pit, medicine inlet channel, vortex cavity, rising air channel and medicine outlet constitute a complete flow channel cavity.

[0023] The powder atomizer device achieves the filling operation of powder in the medicine pit through three steps: sliding open the sliding cover, loading the powder, and closing the sliding cover.

[0024] Specifically, a slide rail is provided on the bottom cover, and the slide cover can slide open and close along the slide rail.

[0025] Furthermore, the powder mist device adopts a sliding cover design that allows for easy opening and closing, facilitating the filling or replenishment of powder in the medicine pit.

[0026] Furthermore, two side air inlets are provided on the side of the vortex cavity;

[0027] The two side air inlets are arranged axially or mirror-symmetrically on both sides of the vortex cavity with the longitudinal axis of the drug inlet channel as the axis of symmetry.

[0028] Alternatively, the two side air inlets are arranged on both sides of the vortex cavity with the center of the vortex cavity as the axis and rotationally symmetrical with respect to the air inlets.

[0029] Furthermore, the inlet end of the rising airway is located above the vortex cavity, and the outlet end of the rising airway is connected to the drug outlet.

[0030] Specifically, on the contact surfaces of the bottom cover and the sliding cover, there are protruding pin structures and corresponding pin hole structures respectively. On the contact surfaces of the sliding cover and the suction nozzle, there are also protruding pin structures and corresponding pin hole structures respectively.

[0031] When the sliding cover slides forward along the slide rail to its position, the corresponding protruding pin structure engages with the corresponding pin hole, thus fixing the sliding cover and the bottom cover, as well as the sliding cover and the nozzle, together as a whole. The bottom cover, the nozzle, and the sliding cover together form a complete closed structure.

[0032] The powder atomizer device described in this technical solution, without changing the internal flow channel structure, allows for arbitrary switching between single-dose reusable and single-dose disposable types by changing the powder filling method.

[0033] Furthermore, the filling method of the powder includes pre-filling the powder into aluminum foil plates containing small doses, breaking off a small dose when needed, placing it into the medicine pit of the device, and then pulling off the aluminum foil strip, thereby realizing the single-filling function of the powder and thus realizing the single-dose reusable function of the entire device.

[0034] Furthermore, the filling method of the powder includes directly filling the powder into the medicine pit of the device, and then sealing the medicine pit with aluminum foil to complete the one-time filling function of the powder, thereby realizing the single-dose disposable function of the entire device.

[0035] Compared with the prior art, the advantages of the present invention are:

[0036] 1. This device has a built-in powder filling section with a sliding cover design, which facilitates powder filling operations or replenishment;

[0037] 2. The device adopts a modular and customized structural design, which allows the shape of the cavity inside the nozzle and bottom cover to be designed individually according to the characteristics of the drug prescription;

[0038] 3. Due to the adoption of a sliding cover structure, the filling or replenishment mode of the built-in drug powder is easy to change, regardless of the shape of the cavity inside the nozzle and bottom cover. While maintaining the main internal structure (i.e., the flow channel structure) unchanged, the device itself can be switched between disposable and reusable types. Attached Figure Description

[0039] Figure 1a This is a schematic diagram of the structure of the bottom cover of the present invention;

[0040] Figure 1b This is a top view of the bottom cover structure.

[0041] Figure 2a This is a schematic diagram of the structure of the suction nozzle of the present invention;

[0042] Figure 2b This is a schematic diagram of the longitudinal cross-sectional structure of the suction nozzle;

[0043] Figure 3a This is a schematic diagram of the sliding cover of the present invention;

[0044] Figure 3b This is a longitudinal sectional view of the sliding cover.

[0045] Figure 4 This is a schematic diagram of the exploded structure of the inhalation device of the present invention;

[0046] Figure 5 This is a schematic diagram of the overall external structure of the inhalation device of the present invention;

[0047] Figure 6This is a cloud diagram of the internal airflow velocity of the inhalation device of the present invention;

[0048] Figure 7 This is a vector diagram of the airflow inside the inhalation device of the present invention.

[0049] In the diagram, 1 is the bottom cover, 2 is the suction nozzle, 3 is the sliding cover, 4 is the medicine pit, 5 is the vortex cavity, 6 is the medicine inlet channel, 7 is the air inlet, 8a is the first side air inlet, 8b is the second side air inlet, 9 is the rising airway, 10 is the medicine outlet, 11 is the slide, and 12 is the curved protrusion. Detailed Implementation

[0050] The invention will now be further described with reference to the accompanying drawings.

[0051] The powder mist device in the technical solution of the present invention consists of three parts: a bottom cover 1, a suction nozzle 2, and a sliding cover 3.

[0052] like Figure 1a and Figure 1b As shown, on the bottom cover 1, along the longitudinal axis of the bottom cover, there are an air inlet 7, a medicine pit 4, a medicine inlet channel 6 and a vortex cavity 5 that pass through in sequence.

[0053] On the side of the vortex cavity, a first side air inlet 8a and a second air inlet 8b are provided; the two side air inlets are symmetrically arranged on both sides of the vortex cavity 5.

[0054] like Figure 1b As shown, the two side air inlets are arranged axially or mirror-symmetrically on both sides of the vortex cavity with the longitudinal axis of the drug inlet channel as the axis of symmetry.

[0055] Alternatively, two side air inlets are arranged symmetrically on both sides of the vortex cavity with the center of the vortex cavity as the axis.

[0056] Depend on Figure 1a As can be seen from 1b, the air inlet, medicine pit, medicine inlet channel and vortex cavity are arranged sequentially on the longitudinal axis of the bottom cover.

[0057] The medicine pit is located in the bottom cover component. In practical applications, the suction nozzle component and the bottom cover component can be installed together first (or the two components can be installed when the device leaves the factory), and then the medicine powder can be filled separately.

[0058] For prescriptions that do not have high humidity requirements, the powder can be filled directly into the medicine pit using filling equipment or manually, and then the sliding cover can be closed. (In the early stages of research and development, the sliding cover can be opened again and the powder can be filled again for use. However, once commercialized, the device is required to be used only once and can be designed to lock when closed.)

[0059] For prescriptions requiring high humidity, consider inserting a custom-shaped aluminum foil blister pack into the medication reservoir, filling it with powder, sealing it with the foil, and then attaching the nozzle and sliding cap. However, this requires an extra step during patient or experimental procedures: the foil strip must be pulled open for the device to properly deliver and disperse the medication.

[0060] like Figure 2a and Figure 2b As shown, in the body of the nozzle 2, an ascending airway 9 and a drug outlet 10 are arranged sequentially along the longitudinal axis of the nozzle.

[0061] The inlet end of the rising airway is located above the vortex cavity, and the outlet end of the rising airway is connected to the drug outlet.

[0062] Figure 3a and Figure 3b In the middle, a curved protrusion 12 is provided below the sliding cover 3.

[0063] When the bottom cover, nozzle, and sliding cover are assembled into a single unit to form a complete flow channel cavity, the curved protruding structure guides the airflow entering from the air inlet into the medicine pit to facilitate the removal of medicine powder.

[0064] like Figure 4 and Figure 5 As shown in the figure, the powder mist device in this technical solution consists of three parts: bottom cover 1, nozzle 2, and sliding cover 3.

[0065] The suction nozzle and the sliding cover are respectively assembled on one side of the bottom cover;

[0066] The suction nozzle is mounted on the front half of the bottom cover; the sliding cover is mounted on the rear half of the bottom cover.

[0067] Combination Figure 1a , Figure 1b and Figure 4 As shown in the figure, in this technical solution, after the bottom cover, the nozzle and the sliding cover are assembled into one piece, the air inlet, the curved protrusion, the medicine pit, the medicine inlet channel, the vortex cavity, the rising air channel and the medicine outlet constitute a complete flow channel cavity.

[0068] The powder atomizer device in this technical solution achieves the filling operation of powder in the medicine pit through three operation steps: "sliding open the sliding cover" → "filling in the powder" → "closing the sliding cover".

[0069] See Figure 1a , Figure 1b and Figure 4 As shown, a slide rail 11 is provided on the bottom cover, and the slide cover can slide along the slide rail to realize the opening and closing action function.

[0070] In this technical solution, the powder mist device adopts a sliding cover design that allows for easy opening and closing, to facilitate the filling or replenishment of powder in the medicine pit.

[0071] Meanwhile, due to the sliding track structure designed on the bottom cover, the sliding cover can slide within a certain limited space. When the sliding cover slides to the closed state (such as...), Figure 5 As shown in the diagram, the two protruding structures at the bottom of the sliding cover will engage with the two pin holes at the bottom of the bottom cover, while the protruding structure at the bottom of the suction nozzle component will engage with the recessed hole of the sliding cover, so that the three components form a closed state.

[0072] Furthermore, in this technical solution, the bottom cap and the nozzle are tightly fitted together via three protruding pins at the bottom of the nozzle. In practical applications, the shape of the flow channel in the bottom cap can be specially designed (while keeping the other two components unchanged) to adapt to different prescription designs and requirements.

[0073] The bottom cover and the suction nozzle can be fitted together by a tight fit, or by ultrasonic welding or other methods to weld the two parts together.

[0074] The powder atomizer device described in this technical solution can switch between single-dose reusable type and single-dose disposable type by changing the filling method of the powder without changing the internal flow channel structure of the device.

[0075] The powder inhaler device described in this technical solution can be transformed from a single-dose disposable type to a single-dose reusable type, depending on the actual drug delivery prescription, while keeping the internal structure unchanged.

[0076] For example, if reuse is required, the powder can be filled into individual small-dose units of aluminum foil vesicles. When using the device, the patient can break off a small portion and fill it into the device. After use, the aluminum foil strip on the vesicle is pulled off and a single dose of the drug is inhaled. After use, the cover is slid open and the empty vesicle is emptied out, and it can be refilled for the next use.

[0077] It should be noted that if the device is a reusable type, the fit between the nozzle and the bottom cover should be made detachable to facilitate cleaning.

[0078] If the medicine is for single use only, slide open the cover, pour the powder directly into the device, and seal the medicine pit with aluminum foil (heat sealing, glue, or other methods can be used). The usage steps of the device remain the same.

[0079] It should be noted that if the device is a single-use, disposable type, the fit between the nozzle and the bottom cover can be changed to be welded (i.e., it cannot be disassembled after installation), thereby ensuring its single-dose, single-use, and disposable function.

[0080] Specifically, the filling method of the medicine powder includes pre-filling the medicine powder into aluminum foil plates containing small doses, breaking off a small dose when needed, placing it into the medicine pit of the device, and then pulling off the aluminum foil strip, thereby realizing the single filling function of the medicine powder, and thus realizing the single-dose reusable function of the entire device.

[0081] Specifically, the filling method of the powder includes directly filling the powder into the medicine pit of the device, and then sealing the medicine pit with aluminum foil to complete the one-time filling function of the powder, thereby realizing the single-dose disposable function of the entire device.

[0082] By adopting this technical solution, while ensuring a small number of parts (no more than 3), the process of filling drug powder in industrial production using this device is simplified (drug powder can also be filled using general-purpose filling equipment). This allows operators to easily fill inhalation product prescriptions (or manually fill them) using simple equipment during the early laboratory research stage of drug formulation development.

[0083] The geometric structure of the flow channel cavity in this technical solution can be found in [reference needed]. Figure 1a and Figure 1b As shown, its overall structure is a vortex structure. Unlike the conventional vortex structure, the geometric structure of the air inlet in this technical solution is designed with a gradually decreasing cross-section. This is to allow the airflow to be accelerated when it enters the dispersion cavity, so as to ensure the turbulence intensity of the airflow within the vortex structure.

[0084] Regarding the path of airflow and the principle of forming gas vortex after adopting the geometric structure of the above-mentioned flow channel cavity, please refer to the relevant content in the Chinese invention patent "A formulation atomizing flow channel for a powder inhaler" previously applied for by the applicant, with the authorization announcement date of August 28, 2020 and authorization announcement number CN107737393B, which will not be described here.

[0085] The optimization of the flow channel structure and shape in this technical solution was obtained through computational fluid dynamics simulation software, mainly from the following aspects:

[0086] 1) By using the given boundary condition of 4 kPa pressure, the velocity of the airflow inside the device is calculated, thereby calculating the theoretical flow velocity and then obtaining the theoretical flow resistance of the device itself.

[0087] The simulation results show that under a pressure difference of 4 kPa, the airflow velocity inside the device is 63.40 L / min. This indicates that the flow channel design used in this technical solution has a medium to low overall flow resistance (CFD calculation convergence accuracy is 10⁻⁴), and the design of the flow channel structure (especially the design of the air inlet) is relatively reasonable.

[0088] 2) By calculating the cloud map using CFD, the movement of airflow inside the device can be determined, and the rationality of the flow channel design can be examined.

[0089] The computational fluid dynamics simulation in this technical solution uses an unstructured mesh and the Reynolds two-equation turbulence model Ke model for calculation. The criteria for judging the convergence of the calculation are: when the residual accuracy of the three-direction velocities x, y, z, turbulent kinetic energy K, and turbulent dissipation rate e reaches about 1×10-4 or less, and the outlet flow rate remains unchanged with the number of iterations, the CFD calculation is judged to be converged. The standard wall function model is used.

[0090] The velocity contour plot and vector plot of the flow channel CFD calculation results in this technical solution are as follows: Figure 6 and Figure 7 As shown in the image.

[0091] The cloud map results show that the highest airflow velocity is concentrated in the middle of the vortex channel (in the cloud map, the darker the color, the higher the airflow velocity, and the lighter the color, the lower the velocity). This location also exhibits the highest turbulence intensity. Furthermore, the airflow vector diagram shows that the airflow successfully swirls within the vortex cavity.

[0092] The technical solution of this invention adopts a sliding cover structure design to facilitate the powder filling or replenishment of the built-in drug powder. At the same time, through the modular structure design, the filling or replenishment mode of the built-in drug powder can be easily changed while maintaining the main flow channel structure. The device itself can be switched between single-use and reusable types to meet different drug prescription needs. In addition, the overall structure of the device itself is simple, the number of parts is simplified to a minimum, and the processing cost is relatively low.

[0093] This invention can be widely used in the design and manufacture of inhalation drug delivery devices.

Claims

1. A single-dose disposable powder aerosol device, characterized in that: The powder atomizer device consists of three parts: a bottom cover, a nozzle, and a sliding cover. The suction nozzle and the sliding cover are respectively assembled on one side of the bottom cover; The suction nozzle is mounted on the front half of the bottom cover; the sliding cover is mounted on the rear half of the bottom cover. A slide rail is provided on the bottom cover, and the slide cover can slide along the slide rail to realize the opening and closing action function; On the bottom cover, along the longitudinal axis of the bottom cover, there are sequentially connected air inlet, medicine pit, medicine inlet channel and vortex cavity. At least one side air inlet is provided on the side of the vortex cavity; In the body of the suction nozzle, an ascending air passage and a drug outlet are arranged sequentially along the longitudinal axis of the suction nozzle. Below the sliding cover, there is a curved protrusion for guiding the airflow from the air inlet into the medicine pit, so as to help remove the medicine powder in the medicine pit. After the bottom cover, nozzle and sliding cover are assembled into one unit, the air inlet, medicine pit, medicine inlet channel, vortex cavity, rising air channel and medicine outlet constitute a complete flow channel cavity. The powder atomizer device achieves the filling operation of the powder in the medicine pit through three steps: sliding open the sliding cover, loading the powder, and closing the sliding cover. The powder inhalation device adopts a sliding cover structure. Without changing the internal flow channel structure of the device, the device can be switched between single-dose reusable and single-dose disposable types by changing the powder filling method. The powder inhalation device itself can be switched between single-use and reusable types to meet different drug prescription requirements. The method of filling the powder includes pre-filling the powder into an aluminum foil plate containing small doses, breaking off a small dose when needed, placing it into the medicine pit of the device, and then pulling off the aluminum foil strip to achieve the single-filling function of the powder, thereby realizing the single-dose reusable function of the entire device. The method of filling the powder also includes directly filling the powder into the medicine pit of the device, and then sealing the medicine pit with aluminum foil to complete the one-time filling function of the powder, thereby realizing the single-dose disposable function of the entire device.

2. The single-dose disposable powder aerosol device according to claim 1, characterized in that: The powder mist device adopts a sliding cover design that allows for easy opening and closing, facilitating the filling or replenishment of powder in the medicine pit.

3. The single-dose disposable powder aerosol device according to claim 1, characterized in that: Two side air inlets are provided on the side of the vortex cavity; The two side air inlets are arranged axially or mirror-symmetrically on both sides of the vortex cavity with the longitudinal axis of the drug inlet channel as the axis of symmetry. Alternatively, the two side air inlets are arranged on both sides of the vortex cavity with the center of the vortex cavity as the axis and rotationally symmetrical with respect to the air inlets.

4. The single-dose disposable powder aerosol device according to claim 1, characterized in that: The inlet end of the rising airway is located above the vortex cavity, and the outlet end of the rising airway is connected to the drug outlet.

5. The single-dose disposable powder aerosol device according to claim 1, characterized in that a protruding pin structure and a corresponding pin hole structure are respectively provided on the contact surface of the bottom cover and the sliding cover, and a protruding pin structure and a corresponding pin hole structure are also respectively provided on the contact surface of the sliding cover and the nozzle. When the sliding cover slides forward along the slide rail to its position, the corresponding protruding pin structure engages with the corresponding pin hole, thus fixing the sliding cover and the bottom cover, as well as the sliding cover and the nozzle, together as a whole. The bottom cover, the nozzle, and the sliding cover together form a complete closed structure.

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