Dual-reservoir dry powder inhaler apparatus

Abstract

A dual-reservoir dry powder inhaler apparatus, belonging to the field of administration apparatuses. A first drug storage barrel (901) and a second drug storage barrel (902) are arranged. A first drug pit (1604) and a second drug pit (1603) are correspondingly arranged below the first drug storage barrel (901) and the second drug storage barrel (902), respectively. A first delivery channel and a second delivery channel are arranged. One end of the first delivery channel and one end of the second delivery channel correspond to the first drug pit (1604) and the second drug pit (1603), respectively, and the other end of the first delivery channel and the other end of the second delivery channel are connected to a dispersion cavity. Two drugs are separately stored in the first drug storage barrel (901) and the second drug storage barrel (902). A "rotary disc" type dose allocation structure is adopted, and the drugs are delivered to the same dispersion cavity by means of the separate drug pits and the separate delivery channels and then delivered to a drug outlet (101) by means of a suction nozzle channel. The processes of dispensing, allocating a single inhalation dose, and delivering to the dispersion cavity to be delivered to the drug outlet (101) for the drugs in the first drug storage barrel (901) and the second drug storage barrel (902) are simultaneously conducted, thereby ensuring that the drugs at two doses can be dispersed and delivered into the body of a patient simultaneously. It can be ensured that the two drugs do not interfere with each other in the storage and dose allocation processes. The dual-reservoir dry powder inhaler apparatus can be widely applied to the field of design and manufacture of dry powder inhaler apparatuses.

Description

A dual-reservoir powder aerosol device Technical Field

[0001] The present invention belongs to the field of devices for introducing media into human body, and in particular relates to an inhalation medication device. Background Art

[0002] Dry Powder Inhaler (DPI) is a special dosage form that uses a specific delivery device (without propellant) to disperse and deagglomerate drug powder into particles of appropriate size, and then delivers the drug to the patient's lungs after the patient actively breathes. It is a type of inhalation preparation.

[0003] This dosage form has the following advantages:

[0004] 1) Avoid the first-pass effect in the patient's liver;

[0005] 2) Low toxicity and side effects (for low-dose small molecule compounds);

[0006] 3) Compared with the pressurized meter dose inhaler (PMDI), which is also an inhalation preparation, the powder inhaler uses the patient's active inhalation airflow to atomize and disperse the drug, so the synergy between the device and the patient is better;

[0007] 4) Compared with nebulized inhalation solutions or suspensions, which are also inhalation preparations, powder inhaler devices are smaller in size and lighter in weight, and can be placed in the patient's pocket for easy portability;

[0008] 5) Compared with liquid preparations, the drug in powder aerosol is more stable in solid form.

[0009] Based on the above advantages, powder inhalers have become a hot research frontier in the field of inhalation preparations at home and abroad.

[0010] Traditional inhaled preparations are commonly used to treat asthma and chronic obstructive pulmonary disease (COPD). The most common ones include the following drugs: inhaled corticosteroids (ICS), long-acting β2-receptor agonists (LABA), long-acting anticholinergic antagonists (LAMA), short-acting β2-receptor agonists (SABA), and short-acting anticholinergic antagonists (SAMA).

[0011] According to international clinical studies, triple therapy with inhaled glucocorticoids, long-acting muscarinic antagonists (LAMAs), and long-acting β2-agonists (LABAs) is effective in treating chronic obstructive pulmonary disease (COPD), especially for patients with severe disease. For example, the German Klaus.F team compared two different doses of triple glucocorticoids and found that the twice-daily triple therapy of budesonide (320 micrograms or 160 micrograms) + glycopyrrolate + formoterol significantly reduced the exacerbation rate in patients with severe COPD compared to either glycopyrrolate + formoterol or budesonide + formoterol.

[0012] Based on the above research, triple drugs (ICS+LABA+LAMA) are increasingly becoming the research focus of many powder inhaler R&D teams.

[0013] However, in actual operation, it was found that directly mixing the three APIs with lactose would present considerable challenges:

[0014] 1) First, ensure that there are no compatibility issues between the three APIs and the excipient lactose, and between the APIs themselves;

[0015] 2) Secondly, ensure that the three APIs are evenly coated on the surface of the lactose carrier during mixing with the lactose carrier, while achieving a mixing uniformity that meets the standards;

[0016] 3) Ensure that during the delivery process, all three APIs can be smoothly detached from the surface of the lactose carrier, thereby achieving an aerodynamic particle size distribution that meets the standards.

[0017] Most of the common reservoir-type powder inhaler products currently on the market are of a "single reservoir" design, that is, the powder inhaler device contains only a single drug storage barrel (for storing drugs) and a single drug pit (for dispensing a single inhalation dose from the drug storage barrel). The corresponding flow channel system is also based on a single reservoir: one drug pit is equipped with a drug delivery channel and a rotating dispersion chamber. In addition, according to relevant regulations, as a powder inhaler device for multi-dose administration, a corresponding "counter" needs to be installed to inform the patient of the remaining drug dose in the powder inhaler device. Since most of the reservoir-type powder inhaler products currently on the market are of a single reservoir design, the transmission design of the "counter" is also based on the entire set of a single reservoir, that is, the dose index of the "counter" is based on a single drug pit.

[0018] The above-mentioned single-reservoir device design does not pose a major problem for the delivery and dispersion of most powder aerosol prescriptions, such as single prescriptions (prescriptions containing only one API), because the entire preparation prescription contains only one API and there will be no compatibility issues with other APIs and interference from other APIs. In addition, the supporting device structures such as the flow channel, counting structure and dosage structure are also custom-designed for a single prescription on a one-to-one basis, and have great functional adaptability.

[0019] However, if the number of APIs in a preparation prescription is two or more (the former is a compound preparation and the latter is a triple prescription preparation), if the above-mentioned single reservoir device design is still used, the following problems may arise:

[0020] 1) First, the single-reservoir design significantly limits the selection of APIs. This is because it is crucial to ensure compatibility between two or more APIs. If compatibility issues exist between APIs and they are stored in the same storage tank, compatibility issues such as interactions between the APIs may arise over time. This can manifest itself in a corresponding increase in impurities within the formulation, potentially exceeding the specified range and significantly impacting product safety (this issue is discussed in 1.1 Technical Field).

[0021] 2) Secondly, as mentioned above, when containing two or more APIs, since the binding strength between each API and the lactose surface varies to varying degrees, ensuring that multiple APIs can be uniformly coated and adhered to the lactose particle surface during mixing is more difficult than with a single drug. During this process, if the API particles fail to bind to the lactose surface, the API particles will agglomerate themselves (API particles used in inhalation powders are typically small and very prone to self-agglomeration), leading to stratification between the API particles and the lactose carrier particles.

[0022] 3) Because different APIs have varying binding strengths with lactose, the device's dispersibility also demands certain capabilities. The device must be designed to simultaneously disperse and deliver all APIs. Modifications and changes to any API can directly or indirectly affect one, two, or more APIs.

[0023] For this type of "triple" drug combination or combination preparation of multiple drugs (the prescription contains at least two or more drugs), the ideal delivery method is: store two different drug prescriptions in two different drug storage spaces (drug storage barrels), first put the drugs into independent drug pits, and then deliver them to the core dispersion cavity through their own independent drug delivery channels (the two drug prescriptions will not come into contact until before the dispersion cavity to avoid compatibility problems), and finally the two prescriptions meet and disperse in the dispersion cavity and are delivered together to the nozzle outlet position.

[0024] In order to deliver and disperse complex triple drugs and multiple drugs, GlaxoSmithKline (UK) has developed a new powder inhaler device that can accommodate triple prescriptions, called the Easy-to-Dose Device. ), This device is a vesicle-type powder inhaler (a type of powder inhaler in which the prescription is individually stored in individual aluminum foil vesicles, which are then sealed and rolled into a blister strip. During use, the patient opens the device lid, triggering a mechanical action within the device that tears the vesicle strip apart, allowing the drug to flow out and be delivered with the patient's inhaled airflow). The basic concept is to mix one API with lactose and fill it into a separate vesicle strip, while the other two APIs are mixed with lactose and filled into another vesicle strip. The three APIs are essentially non-contacting before delivery, with only brief contact within the device flow channel for a few tenths of a second during drug delivery, thus avoiding compatibility issues with raw materials and excipients. The device can also deliver single API prescriptions by using only the channel of one blister roll. While this device achieves triple drug delivery while minimizing the technical complexity of the formulation, it does have a relatively large number of parts (over 22, a significant portion of which are counting gears).

[0025] In addition to the disadvantages in parts (the vesicle device mentioned above has a large number of parts, which is disadvantageous in terms of manufacturing cost), the vesicle-type powder aerosol device is based on a powder discharge design method in which the vesicle strips are peeled off. The internal space design of the device needs to consider the storage space problem after the aluminum foil vesicle strips are peeled off. This is destined to greatly restrict the design of the flow channel of the powder aerosol device itself.

[0026] Because the design of the powder inhaler device needs to meet the requirements of being small and easy for patients to carry, it is constrained and restricted by the space of the entire device, and the flow channel design cannot be too complicated (in fact, the geometric structure of the flow channel inside the inhaler is relatively simple, and it is a straight-through pipe. The dispersion ability of this type of dispersion channel is weak), which makes the dispersion of this device itself very insufficient.

[0027] At the same time, from the perspective of industrial realization, the filling line used for filling vesicle devices requires complete "custom manufacturing." From the production of vesicle strips, to filling with drug powder, to sealing the vesicle strips, and finally to automatic assembly into the device, the cost of the entire process is high and generally cannot be afforded by ordinary companies. In addition, due to the small filling volume limit of vesicle products (generally, vesicle products use small-particle lactose, and the dosage is usually relatively small when converted by the ratio of the raw material and its mixture), the filling accuracy of the filling equipment is also relatively high.

[0028] Based on this, the present invention provides a reservoir powder inhaler device containing two drug storage cartridges (hereinafter referred to as dual reservoirs), which separates the blend of three APIs and lactose into a separate mixture of one of the APIs and lactose, thereby reducing the difficulty of mixing the preparations. At the same time, for an API that is unstable in the preparation or that binds too tightly with lactose and requires special treatment, its impact on the other two APIs can be reduced. Summary of the Invention

[0029] The technical problem to be solved by the present invention is to provide a dual-reservoir powder inhaler device. It stores two drug prescriptions separately in two drug storage barrels, delivers them to the same dispersion chamber through separate drug pits and separate delivery channels, disperses them, and then delivers them to the outlet through a mouthpiece channel. During the operation of the device, corresponding operation prompts are displayed to inform the user that the operation is in place or correct. A corresponding counter tells the patient how much remaining dose is in the device. The drugs in the two drug storage barrels are dispensed from the drug storage barrels to dispense a single inhalation dose, then delivered to the dispersion chamber and delivered to the outlet. The dispensing, dispersion, and delivery processes are carried out simultaneously to ensure that the two doses of drugs can be dispersed and delivered to the patient at the same time.

[0030] The technical solution of the present invention is to provide a dual-reservoir powder inhaler device, which comprises at least a drug storage barrel, a drug pit, a delivery channel, a dispersion chamber, a dosing structure, a knob located on the top of the device, a core transmission structure located inside the device, a turntable, vibrating teeth, and a counting module; and is characterized by:

[0031] The dual-reservoir powder aerosol device comprises at least two medicine storage barrels;

[0032] The two medicine storage barrels are a first medicine storage barrel and a second medicine storage barrel;

[0033] A first medicine pit and a second medicine pit are respectively provided below the first medicine storage barrel and the second medicine storage barrel;

[0034] Two separate delivery channels are provided; the two separate delivery channels are a first delivery channel and a second delivery channel;

[0035] One end of the first delivery channel is corresponding to the first drug pit, and the other end is connected to the dispersion cavity;

[0036] The second delivery channel is arranged corresponding to the second drug pit, and the other end is connected to the dispersion cavity;

[0037] The two drug prescriptions are stored separately in two drug storage cartridges, and a "turntable" type dosing structure / dosing method is adopted. After being delivered to the same dispersion cavity through separate drug pits and separate delivery channels, they are delivered to the outlet through the suction nozzle channel;

[0038] The process of dispensing the drugs in the two drug storage barrels from the drug storage barrels to dispensing the single inhalation dose to the dispersion chamber and then delivering it to the outlet is carried out simultaneously, so as to ensure that the two doses of drugs can be dispersed and delivered to the patient's body at the same time;

[0039] The dual-reservoir powder aerosol device ensures that the two drug powders are stored in their respective storage barrels during the storage of the drugs and do not come into contact with each other.

[0040] The device is operated by turning the knob about 90 degrees back and forth;

[0041] When operating the dual-reservoir powder inhaler device, first turn the knob approximately 90 degrees. When it reaches 90 degrees, a click sound is heard from the device, indicating that the knob has been turned into position. Then, turn the knob back to its initial position. At this time, a click sound is heard from the device again to indicate that the knob has been turned into position, thus completing the action of dispensing a single inhalation dose of medicine from the drug storage cartridge. At the same time, the counter counts one rotation, and the number on the counter surface can be read through the counting window.

[0042] After operating the knob, the required single-inhalation doses of the two drugs can be separated from the two medicine barrels at one time.

[0043] Specifically, the flow channel space of the dual-reservoir powder aerosol device is composed of an upper flow channel component, a middle flow channel component and a lower flow channel component.

[0044] Furthermore, the upper flow channel component, the middle flow channel component and the lower flow channel component constitute a first space channel and a second space channel for the flight of drug particles from the first drug pit and the second drug pit respectively. The first space channel is for the flight of drug particles from the first drug pit, and the second space channel is for the flight of drug particles from the second drug pit.

[0045] Specifically, the flow channel upper component, the flow channel middle component and the flow channel lower component are fixed as one body.

[0046] Specifically, a turntable is provided; the turntable and the flow channel lower component are in a fitted state after assembly;

[0047] A first medicine pit and a second medicine pit are provided on a surface of the turntable facing the lower component of the flow channel;

[0048] Two medicine storage spaces are formed between the turntable and the first medicine storage barrel and the second medicine storage barrel respectively;

[0049] When the knob is turned about 90 degrees, the two medicine pits on the turntable will be simultaneously rotated to the bottom of the first medicine storage barrel and the second medicine storage barrel. When the two medicine pits are rotated into place, the powder in the first medicine storage barrel and the second medicine storage barrel will be discharged from the first medicine storage space and the second medicine storage space into the first medicine pit and the second medicine pit respectively, completing the divided doses of the corresponding medicine pits at the same time. At this time, the powders in the two medicine pits will still not touch each other;

[0050] When the knob is rotated back to the initial state, the second medicine well and the first medicine well will be simultaneously rotated back to the positions of the two first flow channel openings and the second flow channel openings of the flow channel lower component, waiting for the patient to inhale.

[0051] Furthermore, a turntable vibration tooth is provided below the turntable, and the turntable vibration tooth is undulating and evenly distributed at 90 degrees around the matching hole;

[0052] A vibrating tooth is provided below the rotating disk, and the teeth on the vibrating tooth are uniformly distributed at 90 degrees around the slot;

[0053] When the knob is turned for the first time, the motion between the tooth profile on the vibrating tooth and the vibrating tooth on the turntable below the turntable is relative sliding-separation-knocking engagement;

[0054] When the knob is rotated for the second time, the teeth on the vibrating teeth mesh with the vibrating teeth on the turntable below the turntable, and they rotate coaxially without separating;

[0055] Since the two drug prescriptions loaded in the first medicine storage barrel and the second medicine storage barrel may have different fluidities, a double-vibration knocking vibration mode is adopted to ensure to the greatest extent that the two prescriptions with different fluidities can be accurately dispensed into their respective medicine pits.

[0056] Specifically, the core transmission structure consists of a transmission cylinder, a compression spring, a vibrating tooth, a transmission pawl and a cover. The turntable rotates in the same direction as the knob, so that the turntable can rotate back and forth 90 degrees while driving the counter to rotate in one direction.

[0057] Specifically, the counting module of the dual-reservoir powder aerosol device is composed of a knob, a counter, a transition gear and a counter cover;

[0058] The counter cover and the knob are matched with each other through protrusions and steps. The steps serve as supporting parts for the counter cover, and the protrusions around the inner side of the knob serve as limiters for the counter cover, so that the counter cover can rotate in the same direction and angle as the knob.

[0059] Furthermore, the dual-reservoir powder aerosol device can store at least two different formulations simultaneously, while ensuring that the two formulations do not interfere with each other during storage and dosing.

[0060] The dosing structure / dosing method of the dual-reservoir powder aerosol device is achieved by rotating a turntable; the turntable rotates back and forth 90 degrees to respectively release the drug powder in the first drug storage barrel and the second drug storage barrel into the first drug pit and the second pit, and then the powder in the two drug pits is respectively transferred to the first flow channel and the second flow channel for delivery; before being delivered, the two prescription powders always remain in a non-contact state.

[0061] Specifically, during operation, the dual-reservoir powder aerosol device needs to be held vertically to properly perform its functions.

[0062] Compared with the prior art, the advantages of the present invention are:

[0063] 1. The dual-reservoir powder aerosol device of the present invention can simultaneously store two different formulations (containing different APIs) separately in two different storage barrels to avoid contact with each other, thereby avoiding the compatibility problem between different APIs and excipients.

[0064] 2. For compound preparations and triple preparations, it is more difficult to mix two or three APIs with lactose at the same time. The dual-reservoir powder inhaler device of the present invention can reduce the difficulty of the preparation process to a certain extent: for compound preparations, the two APIs can be mixed with the lactose carrier separately, which is less difficult than mixing the two APIs with lactose at the same time. For triple preparations (containing three different APIs), one of the APIs that is less stable, easily reacts with the other two APIs, and easily binds tightly to lactose can be isolated and mixed with lactose alone, while the other two APIs are mixed with lactose. This is also less difficult than mixing the three APIs at the same time.

[0065] 3. The dual-reservoir powder inhaler device of the present invention does not require prior activation. Compared to the Symbicort Turbo device, this reduces unnecessary operation. This is because the drug reservoir of the dual-reservoir powder inhaler device of the present invention rotates 90 degrees, directly moving back and forth between the drug storage barrel and the flow channel. The patient simply operates the device knob to dispense a single inhalation dose directly into the flow channel for inhalation.

[0066] 4. The dual-reservoir powder inhaler device of the present invention utilizes snap-fit ​​mechanisms, such as the snap-fit ​​between the cover 20 and the drive cylinder 13, and the snap-fit ​​between the turntable 16 and the counter cover 12. These snap-fit ​​mechanisms significantly facilitate installation (reducing the spring force of the compression spring 14, which could otherwise hinder installation due to deformation). Furthermore, the design of the device body facilitates filling.

[0067] 5. The dual-reservoir powder inhaler device of the present invention incorporates a knob operation prompt sound in its operation design. When the patient turns the knob twice, a "click" prompt sound will be emitted from inside the device when the knob 5 is turned to the corresponding position.

[0068] 6. Following the previous step, the sound structure that produces a "click" sound will vibrate. Based on the operational design, the "click" sound will sound twice, generating two vibrations at the same time, which can maximize the effective drop of prescriptions with different fluidities stored in two different storage barrels into the medicine pit.

[0069] 7. The present invention utilizes a 90-degree arc trajectory design for the independent motion trajectories of the two independent drug pits, fundamentally avoiding interference between the two motion trajectories (the trajectories of the drug pits moving from the drug storage barrel's discharge port to the flow channel opening after dispensing a single inhaled dose). Furthermore, because the two independent drug pits move independently from the drug storage barrel's discharge port to the flow channel opening, they better meet the advantage of "ensuring compatibility between the three APIs and the excipient lactose, as well as between the APIs themselves."

[0070] Summary of the Figures

[0071] Figure 1a is a schematic diagram of the device of the present invention;

[0072] FIG1b is a schematic diagram of the appearance of the device after the knob of the present invention is rotated 90 degrees;

[0073] FIG2 is a schematic cross-sectional view of the device of the present invention;

[0074] FIG3 is a schematic diagram of the appearance structure of the knob of the present invention;

[0075] FIG4 is a schematic diagram of the top view of the knob structure of the present invention;

[0076] FIG5 is a schematic diagram of the assembly effect of the knob and the counter of the present invention;

[0077] FIG6 is a schematic top view of the assembled knob and counter of the present invention;

[0078] FIG7 is an exploded view of the knob and counter cover of the present invention;

[0079] FIG8 is a schematic diagram of the outer structure of the lower housing of the present invention;

[0080] FIG9 is a side view of the lower housing of the present invention;

[0081] Figure 10 is a top view of the lower housing of the present invention;

[0082] FIG11 is a schematic diagram of the assembly effect of the knob and the lower housing of the present invention;

[0083] FIG12 is a top view of the assembly of the knob and the lower housing of the present invention;

[0084] FIG13 is an exploded view of the assembly of the knob and the lower housing of the present invention;

[0085] FIG14 is a three-dimensional view of the assembled appearance of the knob and the lower housing of the present invention;

[0086] FIG15 is a schematic diagram of the appearance structure of the core transmission structure of the present invention;

[0087] FIG16 is an exploded view of the core transmission structure of the present invention;

[0088] FIG17 is a schematic diagram of the three-dimensional structure of the transmission cylinder of the present invention;

[0089] FIG18 is a schematic diagram of the top view of the transmission cylinder of the present invention;

[0090] FIG19 is a schematic cross-sectional view of the transmission cylinder of the present invention;

[0091] Figure 20 is a schematic structural diagram of the transmission pawl of the present invention;

[0092] 21 is a schematic diagram of the top view of the transmission pawl of the present invention;

[0093] Figure 22 is a schematic diagram of the cooperation between the transmission pawl and the transmission cylinder;

[0094] FIG23 is a schematic diagram of the external structure of the vibrating tooth;

[0095] Figure 24 is a cross-sectional view of the transmission structure;

[0096] Figure 25 is an exploded view of the installation of the transmission structure and the counting structure;

[0097] Figure 26 is a schematic diagram of the installation effect of the transmission structure and the counting structure;

[0098] Figure 27 is a schematic diagram of the outer structure of the turntable;

[0099] FIG28 is a schematic diagram of the turntable's appearance when viewed from above;

[0100] FIG29 is a schematic diagram of the three-dimensional structure of the counter cover;

[0101] FIG30 is a schematic diagram of the turntable after installation;

[0102] FIG31 is a cross-sectional view of the installation effect of the turntable;

[0103] FIG32 is a schematic diagram of the separation structure of the vibration teeth;

[0104] FIG33 is a schematic diagram of a vibrating tooth when relative displacement occurs;

[0105] FIG34 is a schematic structural diagram of the vibrating teeth in an engaged and unseparated state;

[0106] Figure 35 is a schematic diagram of the shaft hole fit between the vibration tooth and the transmission pawl;

[0107] FIG36 is a cross-sectional view of the drug storage structure of the present invention;

[0108] Figure 37 is a schematic diagram of the relative positions of the medicine pit when it is moved to the bottom of the medicine barrel;

[0109] Figure 38 is a schematic diagram of the state where the two medicine pits are rotated back to their initial positions;

[0110] FIG39 is a schematic diagram of the outer structure of the flow channel lower component;

[0111] FIG40 is a side view of the outer shape of the flow channel lower member;

[0112] Figure 41 is a schematic diagram of the assembly method of the flow channel lower component;

[0113] FIG42 is a schematic cross-sectional view of the housing;

[0114] FIG43 is a schematic diagram of the three-dimensional structure of the housing;

[0115] Figure 44 is a schematic diagram of the nozzle installation and fixing direction;

[0116] Figure 45 is a schematic diagram of the nozzle fixing effect;

[0117] FIG46 is an exploded view of the flow channel upper component, the flow channel middle component, and the flow channel lower component;

[0118] Figure 47 is a schematic diagram of the external structure of the flow channel upper component;

[0119] FIG48 is a schematic diagram of the appearance structure of the flow channel after assembly;

[0120] FIG49 is a schematic structural diagram of a dual-particle channel according to the present invention;

[0121] FIG50 is a schematic diagram of the appearance of the main body of the device of the present invention;

[0122] Figure 51 is a schematic diagram of the cartridge cover assembly;

[0123] Figure 52 is a schematic diagram of the device after assembly;

[0124] Figure 53 is a schematic diagram of the appearance of the device nozzle;

[0125] Figure 54 is a schematic diagram of the inner structure of the nozzle of the device;

[0126] FIG55 is a schematic cross-sectional view of the device nozzle;

[0127] Figure 56 is a schematic diagram of the appearance structure of the upper cover;

[0128] Figure 57 is a schematic diagram of the relative position distribution of the medicine storage barrels and the medicine pit;

[0129] Figure 58 is a schematic diagram of the appearance of the transition gear;

[0130] Figure 59 is a schematic diagram of the appearance of the cover;

[0131] FIG60 is a schematic diagram of the appearance of the counter from an upward perspective;

[0132] Figure 61 is a schematic diagram of the meshing of the counting module gears;

[0133] FIG62 is a schematic diagram of the shotweight test results of the pure lactose formulation of the present invention;

[0134] Figure 63 is a schematic diagram of the shotweight experimental results of the lactose + API formulation of the present invention.

[0135] In the figure, 1 is the device nozzle; 2 is the device upper cover; 3 is the shell; 4 is the device air inlet; 5 is the knob; 6 is the counting window; 7 is the flow channel upper component; 8 is the flow channel middle component; 9 is the flow channel lower component; 10 is the counter; 11 is the transition gear; 12 is the counter cover; 13 is the transmission cylinder; 14 is the compression spring; 15 is the vibrating tooth; 16 is the turntable; 17 is the transmission pawl; 18 is the medicine barrel cover; 19 is the lower shell; 20 is the lid;

[0136] 101 is the medicine outlet; 102 is the square slot; 103 is the card slot; 201 is the buckle hole; 202 is the edge of the upper cover;

[0137] 301 is the edge; 302 is the buckle; 303 is the upper cover buckle; 304 is the upper edge of the nozzle; 305 is the nozzle buckle;

[0138] 501 is a protrusion; 502 is a step; 503 is a gear shaft hole; 504 is a limit block; 505 is a buckle structure;

[0139] 701 is a latch; 702 is a latch; 703 is a latch; 781 is the leading edge of the flow channel; 7891 is the air inlet; 7892 is the air inlet; 7893 is the first space channel; 7894 is the second space channel;

[0140] 801 is a pin hole; 802 is a pin hole; 803 is a pin hole; 804 is a pin hole; 805 is a pin hole; 806 is a pin hole; 807 is a pin hole; 808 is a pin hole;

[0141] 901 is the first medicine storage barrel; 902 is the second medicine storage barrel; 903 is the first flow channel opening; 904 is the second flow channel opening; 906 is the center hole; 907 is the edge of the flow channel lower component;

[0142] 9001 is a latch; 9002 is a latch; 9003 is a latch; 9004 is a latch; 9005 is a latch;

[0143] 1001 is the gear tooth; 1002 is the top block; 1003 is the positioning hole;

[0144] 1101 is the lower gear; 1102 is the upper gear; 1103 is the positioning hole;

[0145] 1201 is the counter cover protrusion; 1202 is the buckle hole; 1203 is the transition gear shaft hole; 1204 is the transmission main shaft gear shaft hole; 1205 is the concave groove;

[0146] 1301 is a clamping block; 1302 is a clamping hole; 1303 is a ratchet groove; 1304 is a spring groove; 1305 is a round hole;

[0147] 1501 is a slot; 1502 is a tooth shape;

[0148] 1601 is a buckle; 1602 is a buckle; 1603 is a 10mg medicine pit; 1604 is a 5mg medicine pit; 1605 is a turntable vibration tooth; 1606 is a matching hole; 1607 is a cantilever; 1608 is a cantilever; 1691 is a medicine storage space; 1692 is a medicine storage space;

[0149] 1701 is the guide rail; 1702 is the transmission shaft; 1703 is the positioning point; 1704 is the ratchet; 1705 is the transmission gear;

[0150] 1901 is the card slot; 1902 is the fixed card slot; 1903 is the rotation limit block; 1904 is the positioning block; 1905 is the edge of the suction nozzle; 1906 is the arc channel; 2001 is the cover buckle. DETAILED DESCRIPTION

[0151] The present invention will be further described below with reference to the accompanying drawings and embodiments.

[0152] Against the backdrop of existing technology, the present invention provides a dual-reservoir powder inhaler device containing two medicine storage barrels, which can achieve the following functions:

[0153] 1) Two drug prescriptions are stored separately in two drug storage cartridges, delivered to the dispersion chamber through separate drug pits and separate delivery channels, and then delivered to the outlet through the suction nozzle channel.

[0154] 2) During the operation of the device, there will be corresponding operation prompts to tell the user that the operation is in place or correct.

[0155] 3) There is a corresponding counter to tell the patient how much dose is left in the device.

[0156] 4) The drugs in the two drug storage barrels are dispensed from the drug storage barrels to distribute the single inhalation dose and then delivered to the dispersion chamber and delivered to the outlet at the same time, so as to ensure that the two doses of drugs can be dispersed and delivered to the patient's body at the same time.

[0157] 5) The sizes of the two medicine pits are adjustable, which means customization.

[0158] 6) The medicines in the two medicine storage barrels can be accurately dispensed into the medicine pit at the same time.

[0159] Compared with a simple single-reservoir system, a dual-reservoir powder inhaler device with two drug storage barrels has the following difficulties in the design process:

[0160] a. After different drugs are mixed with lactose, the prescription has different flow characteristics, and the flowability will affect the accuracy of the drug prescription from the storage barrel to the medicine pit.

[0161] In the present invention, the prescriptions stored in two different medicine storage barrels may have different fluidities (one prescription with good fluidity can be easily and accurately dispensed into the medicine pit; the other prescription with poor fluidity is more difficult to dispense and requires a certain amount of knocking before accurate dispensing). Therefore, it is necessary to design a vibration system that can simultaneously meet the dispensing requirements of two different prescriptions.

[0162] b. After dispensing a single-puff dose from the drug reservoir outlet, the drug pit must have two distinct paths to the flow channel outlet, ensuring they do not intersect. For a single-reservoir powder inhaler device, based on a single drug reservoir and delivery channel, the drug pit has only one path from the reservoir outlet to the flow channel outlet (the initial location of the delivery channel), thus providing greater design flexibility (and greater ease).

[0163] The present invention adds a medicine storage barrel based on the original single reservoir design. According to the purpose of the present invention, the medicine storage barrel must be independent of the original medicine storage barrel, so it has two drug delivery ports. In addition, according to the purpose of the present invention, the delivery channels of the two drugs must also be established independently, so it also has two flow channels. Therefore, in the present invention, there are two movement paths from the drug delivery port to the flow channel port. Based on the principles of mechanical design and processing and manufacturing, these two paths cannot form an intersection. Once they intersect, interference will occur in the part design (if there is interference, the structure design and processing cannot be done).

[0164] c. Following difficulty b, after the two medicine pits release medicine from their respective medicine barrels, they must also complete counting at the same time while moving along their own independent motion trajectories to the flow channel outlet. For a single-reservoir powder inhaler device, because there is only one above-mentioned motion trajectory, the linkage transmission design space of the counting structure is relatively large and relatively easy. The dual-reservoir powder inhaler device designed by the present invention has two above-mentioned trajectory channels. Therefore, when designing the counting structure, it is necessary to index and link the two trajectory movements at the same time, so that the two medicine pits can simultaneously release medicine from the medicine barrels and distribute the dosage and move to the flow channel outlet, and complete the counting at the same time (no order).

[0165] d. The final design of the powder inhaler device must be large enough to be easily held in the patient's hand. Even with the addition of two drug storage barrels, the overall volume of the powder inhaler device should not be much larger than that of a single reservoir, and should not even be changed. This poses a great challenge to the overall design and arrangement of parts, because the flow channel cannot be designed with large bends (benches designed to save space). If such large bends occur, drug particles may easily remain in the dispersion channel during delivery.

[0166] In view of the above technical status and research and development difficulties, the technical solution of the present invention adopts the following measures:

[0167] 1) Design a dual-reservoir powder inhaler device, i.e., a device with two storage tanks capable of storing two different drug prescriptions, such as a compound preparation + a single preparation, or a single preparation + a single preparation. For the former combination, a compound preparation (two APIs) + a single preparation (one API) can contain three APIs. APIs with compatibility issues or poor stability can be isolated and filled as separate preparations.

[0168] 2) Reduce the difficulty of formulation technology. For powder inhaler prescriptions, mixing a single API (or two APIs) and lactose is less difficult than blending three APIs with lactose at the same time.

[0169] 3) The designed dual-reservoir powder inhaler device can include the functions of a single-reservoir powder inhaler device, that is, the powder inhaler device can be used to deliver a single-type dosage form containing a single API or two APIs (the device can be used as a single-reservoir device).

[0170] 4) When designing the parts of the dual-reservoir powder aerosol device, the principles of easy installation and modular installation are taken into consideration so that it can be easily automated on an industrial production line.

[0171] 5) The dual-reservoir powder inhaler device designed in the present invention adopts a "turntable" type dosing structure. Compared with existing products of this type (such as Symbicort), the device of the present invention can eliminate the activation operation in its structural design (the addition of the activation operation is theoretically not conducive to patient use).

[0172] Specifically, the complete technical solution of the present invention is as follows:

[0173] The appearance of the dual-reservoir powder aerosol device of the present invention is shown in FIG1a .

[0174] When the patient operates the dual-reservoir powder inhaler device, he first turns the knob 5 in Figure 1a by about 90 degrees (when turned to 90 degrees, a clicking sound will be heard from the device, prompting the patient that the knob has been turned into place). The effect after the knob 5 is turned 90 degrees is shown in Figure 1b; then, the knob 5 is turned back to the initial state of Figure 1a (at this time, a sound will be heard from the device again to prompt the patient that the knob has been turned into place), thereby completing the action of dispensing a single inhalation dose of medicine from the drug storage cartridge (the patient needs to hold the device vertically when turning the knob); at the same time, the counter 10 counts one rotation, and the number on the surface of the counter 10 can be read by the patient through the counting window 6 in Figure 1a.

[0175] Figure 2 is a cross-sectional view (also known as an assembly view) of the overall structure of the dual-reservoir powder aerosol device, in which the counter cover 12 and the knob 5 are mated via protrusions 501 and steps 502 (the structures of the protrusions 501 and steps 502 are shown in Figures 3 and 4, respectively, with the three straight lines in Figure 4 pointing to three identical protrusions 501). The steps 502 serve as supporting parts for the counter cover 12, and the protrusions 501 around the inner side of the knob 5 serve as limiters for the counter cover 12, allowing the counter cover 12 to rotate in the same direction and angle as the knob 5.

[0176] The assembled effect and installation direction of the counter cover 12 and the knob 5 are shown in Figures 5 and 6 respectively. A transition gear 11 and a counter 10 are correspondingly installed between the counter cover 12 and the knob 5 (as shown in Figure 7. The exploded view and arrow direction of Figure 7 show how the counter cover 12, the transition gear 11, the counter 10 and the knob 5 are assembled together). The transition gear 11 is matched with the gear shaft hole 503 at the bottom of the knob 5 (the position and shape of the gear shaft hole 503 are shown in Figures 3 and 4) as a rotating base, and then meshes with the gear teeth 1001 on the inside of the counter 10 (as shown in Figure 7).

[0177] In summary, the knob 5 , the counter 10 , the transition gear 11 and the counter cover 12 in FIG. 7 together constitute the counting module of the dual-reservoir powder aerosol device as shown in FIG. 5 and FIG. 6 .

[0178] The counting module is assembled by snapping the snap structure 505 (the position and shape of the snap structure 505 are shown in Figure 3) into the slot 1901 on the side of the lower shell 19 (the structure of the lower shell 19 is shown in Figures 8, 9 and 10, and the shape of the slot 1901 on the lower shell 19 is shown in Figure 9).

[0179] In this technical solution, the card slot 1901 has two functions:

[0180] 1) Limiting the up and down movement of the counting module composed of the knob 5, the counter 10, the transition gear 11 and the counter cover 12 (Figures 5 and 6 respectively show the side view and top view of the counting module, and Figure 7 shows the exploded view of the counting module).

[0181] 2) The knob 5 can be rotated about 90 degrees along the slot 1901 relative to the lower shell 19 (there is a rotation limit block 1903 in the slot 1901. After the knob 5 is rotated 90 degrees, the rotation limit block 1903 will abut against the buckle structure 505. The position structure of the rotation limit block 1903 is shown in Figure 9).

[0182] After the snap structure 505 on the knob 5 is snapped into the slot 1901, the assembly effect between the knob 5 and the lower shell 19 is shown in Figures 11, 12, 13 and 14. Because the lower shell 19 is a hollow structure (as can be seen from Figure 8), there is enough space for the counter cover protrusion 1201 on the counter cover 12 to move.

[0183] The arrow in Figure 12 indicates the direction of rotation of knob 5. Since counter cover 12 rotates in the same direction as knob 5, it can freely rotate relative to lower housing 19 within arcuate channel 1906 of lower housing 19 (arcuuus channel 1906 limits the rotation angle of counter cover protrusion 1201 of counter cover 12 to 90 degrees). Once lower housing 19 is assembled, the counter module is finally installed. The arrow in Figure 13 indicates the assembly direction of knob 5 relative to lower housing 19.

[0184] The core transmission structure of the dual-reservoir powder aerosol device is shown in Figures 15 and 16. This transmission structure can achieve: while the turntable 16 rotates back and forth 90 degrees (the turntable 16 rotates in the same direction as the knob 5), it drives the counter 10 to rotate unidirectionally.

[0185] The core transmission structure consists of a transmission cylinder 13, a compression spring 14, a vibration tooth 15, a transmission pawl 17 and a cover 20, as shown in FIG16 (the arrows in FIG16 are the directions in which the parts are installed).

[0186] 19 , 20 and 21 respectively (the structure of the transmission cylinder 13 is shown in FIG17 , FIG18 and FIG19 , and the structure of the transmission pawl 17 is shown in FIG20 and FIG21 ). During installation, the transmission pawl 17 is first inserted into the pawl groove 1303 on the inner side of the transmission cylinder 13 to complete the installation of the transmission pawl 17, and the effect is shown in FIG22 ; secondly, the compression spring 14 is placed in the transmission cylinder 13, and there is a spring groove 1304 in the transmission cylinder 13 for placing the compression spring 14 (the structure of the spring groove 1304 can be seen from the cross-sectional view of FIG19 ), and then the slot hole 1501 of the vibrating tooth 15 is aligned with the guide rail 1701 of the transmission pawl 17 and inserted (the structure of the vibrating tooth 15 is shown in FIG23 ), and finally the cover 20 is closed to complete the installation of the core transmission structure, and the installation cross-sectional view is shown in FIG24 .

[0187] After the core structure is installed, it is inserted into the lower shell 19. By snapping the blocks 1301 on both sides of the transmission cylinder 13 into the positioning blocks 1904 in the lower shell 19, the counting module and the transmission structure are assembled (as shown in Figures 25 and 26).

[0188] From the perspective of Figure 26, it can be seen that the blocking block 1301 of the transmission cylinder 13 is stuck in the positioning block 1904 of the lower shell 19. The situation expressed in this figure is used to illustrate the transmission structure composed of the transmission cylinder 13, compression spring 14, vibration tooth 15, transmission pawl 17 and cover 20. During the rotation of the knob 5 and the counter cover 12 relative to the lower shell 19, they are stationary relative to the lower shell 19 and do not rotate.

[0189] After the above structure is installed, the turntable 16 is snapped into the snap holes 1202 on the counter cover protrusion 1201 (the structure of the counter cover 12 is shown in Figure 29) using the snaps 1601 and 1602 on both sides (these two snaps have the same appearance). Once the snaps 1601 and 1602 on both sides of the turntable 16 are engaged, the turntable 16 can rotate synchronously with the counter cover 12. When the counter cover 12 rotates approximately 90 degrees, the turntable 16 rotates in the same direction and the same angle.

[0190] In summary, the rotation of the knob 5 drives the counter 12 to rotate, and due to the snap fit between the counter 12 and the turntable 16, the counter 12 drives the turntable 16 to rotate, so the rotation of the turntable 16 and the knob 5 are synchronous and in the same direction.

[0191] The outer structure of the turntable 16 is shown in Figures 27 and 28, and the installation effect of the turntable 16 is shown in Figures 30 and 31.

[0192] As can be seen from Figures 30 and 31, the turntable 16 is now firmly locked with the counter 12 by the buckle. When the turntable 16 starts to rotate in the same direction as the knob 5, the turntable vibration tooth 1605 below the turntable 16 (the outer structure of the turntable vibration tooth 1605 is shown in Figure 28) is in "forward tooth" meshing with the tooth shape 1502 on the vibration tooth 15 (the outer shape of the tooth shape 1502 on the vibration tooth 15 is marked with a straight line in Figure 23), and the vibration tooth 15 does not rotate relative to the lower housing 19 at this time. Therefore, the vibration tooth 15 and the turntable vibration tooth 1605 will slide relative to each other along the rotation axis (vibration). The schematic diagram of the movement of the movable teeth when sliding relative to each other is shown in FIG33 ), and under the force of the inclined surface of the turntable vibrating tooth 1605, the vibrating tooth 15 will move along the guide rail 1701 on the transmission pawl 17 by squeezing the compression spring 14 (as shown in FIG32 , the vibrating tooth 15 in the figure has been separated from the turntable 16 and moved a short distance, and the structure of the turntable vibrating tooth 1605 can be seen in the figure. In contrast, FIG34 shows the state in which the vibrating tooth 15 and the turntable 16 are not separated, and the turntable vibrating tooth 1605 is hidden therein).

[0193] After rotating 90 degrees, the turntable vibrating tooth 1605 will be stuck in the next tooth groove of the vibrating tooth 15. At this time, under the action of the compression spring 14 releasing the elastic potential energy (the installation position of the compression spring 14 is shown in Figure 31), the mutual collision between the turntable vibrating tooth 1605 and the vibrating tooth 15 will make a sound. This is the reason why the patient made a sound when operating for the first time. At the same time, the collision will also generate a vibration inside the device, thereby helping the drugs in the first medicine storage barrel 901 and the second medicine storage barrel 902 to effectively fall into the 5mg medicine pit 1604 (also called the second medicine pit) and the 10mg medicine pit 1603 (also called the first medicine pit) respectively.

[0194] During the above process, the vibrating tooth 15 does not rotate relative to the lower shell 19 because the transmission pawl 17 realizes axial hole matching with the slot 1501 on the vibrating tooth 15 through its guide rail 1701 (as shown in Figure 35), and the shape of the slot 1501 and the guide rail 1701 is a straight line (as shown in Figures 20 and 23), so the vibrating tooth 15 can rotate coaxially and synchronously with the transmission pawl 17.

[0195] When knob 5 is first turned, the direction of rotation of dial 16 (due to the fit with counter cover 12, dial 16 and knob 5 rotate synchronously in the same direction) is opposite to the direction of pawl 1704 relative to transmission pawl 17 (the assembly position of transmission pawl 17 within transmission cylinder 13 is shown in FIG22 ). At this time, pawl 1704 is pressed against pawl groove 1303 in the direction of rotation. Therefore, transmission pawl 17 does not rotate, and correspondingly, due to the fit of the "slotted shaft hole", the vibration tooth 15 does not rotate either (at this time, the vibration tooth 15 only moves a short distance along guide rail 1701, as shown in FIG32 and FIG35 , respectively, with the arrow in FIG35 indicating the direction of movement of the vibration tooth 15).

[0196] When the patient turns the knob 5 back to the initial position (the initial position is shown in FIG1a ), the meshing direction between the vibrating teeth 15 and the turntable vibrating teeth 1605 is “reverse gear (inverted gear)”, and the relative motion between the two is no longer relative sliding, but coaxial and codirectional rotation (the turntable vibrating teeth 1605 under the turntable 16 will push against the tooth shape 1502 of the vibrating teeth 15 during the rotation process). Therefore, when the turntable 16 is rotated back to the initial state along with the knob 5, the turntable vibrating teeth 1605 structure under the turntable 16 will rotate with the vibrating teeth 15. Due to the meshing between the vibrating teeth 15 and the transmission pawl 17, the vibrating teeth 15 and the transmission pawl 17 are in a state of rotation. The shaft-hole fit is achieved through a straight slot hole, so the vibrating tooth 15 will synchronously drive the transmission pawl 17 to rotate. During the rotation of the transmission pawl 17, the pawl 1704 is squeezed and deformed by the wall of the pawl groove 1303. When the knob 5 returns to its initial position, the pawl 1704 will return to its original state and be stuck in the corresponding position of the pawl groove 1303. At this time, the pawl 1704 will make a sound because it is squeezed and deformed by the wall of the pawl groove 1303 and then restored to its deformation and stuck in the pawl groove 1303. This is the reason for the sound when the patient operates the rotary knob 5 for the second time.

[0197] At the same time as the sound is emitted, the transmission pawl 17 as a whole rotates 90 degrees along the axis. Similarly, the transmission gear 1705 below the transmission pawl 17 also rotates 90 degrees in one direction along the axis.

[0198] Based on the aforementioned principle, the sound produced by the patient turning the knob 5 through 90 degrees is louder than the second sound produced when the knob 5 is turned back to its initial position. This is because the first sound is produced by the vibration tooth 15 striking the turntable vibration tooth 1605 under the compression of the compression spring 14, while the second sound is produced solely by the deformation of the pawl 1704. Therefore, the first sound is louder in terms of force. Similarly, this sound also generates corresponding vibrations, thereby helping the drugs in the first and second medicine storage barrels 901 and 902 to effectively fall into the 5mg medicine well 1604 and 10mg medicine well 1603, respectively.

[0199] Since the two drug prescriptions loaded in the first drug storage barrel 901 and the second drug storage barrel 902 may have different fluidities, the two vibrations can ensure to the greatest extent that the two prescriptions with different fluidities can be accurately dispensed into their respective medicine pits.

[0200] The above is the basic principle of how the transmission structure composed of the transmission cylinder 13, the compression spring 14, the vibrating teeth 15, the transmission pawl 17 and the cover 20 converts the reciprocating rotation of the turntable 16 into the unidirectional rotation of the transmission gear 1705 under the transmission pawl 17. The unidirectional rotation of the transmission gear 1705 will synchronously drive the rotation of the transition gear 11 and the counter 10, thereby realizing counting (as can be seen from Figure 31, the transmission gear 1705 and the transition gear 11 and the counter 10 are engaged), and the counting function can realize the indexing of the doses dispensed from two independent medicine storage barrels at the same time.

[0201] As a reservoir-type powder inhaler device, one of the most important functions is to store drugs. As a dual-reservoir powder inhaler device, it needs to ensure the following two functions:

[0202] 1) During the storage of medicines, ensure that the two drug powders are stored in their respective storage barrels and do not come into contact with each other.

[0203] 2) After the patient operates the knob 5 , the required single inhalation dose can be separated from the two medicine barrels.

[0204] In the present invention, the turntable 16 and the flow channel lower member 9 are in a fitted state after assembly, and the fitted state is shown in FIG. 36 .

[0205] Due to the fit between the two, two medicine storage spaces 1691 and 1692 (circled with dotted lines in FIG36 ) are formed between the turntable 16 and the first medicine storage barrel 901 and the second medicine storage barrel 902 , respectively.

[0206] After rotating the knob 5 about 90 degrees, the two medicine pits on the turntable 16 will be rotated to the bottom of the first medicine storage barrel 901 and the second medicine storage barrel 902 respectively (as shown in Figure 37). At the same time, the powder in the first medicine storage barrel 901 and the second medicine storage barrel 902 will be discharged from the medicine storage space 1691 and the medicine storage space 1692 to the 5mg medicine pit 1604 and the 10mg medicine pit 1603 respectively. At this time, the medicine powders in the two medicine pits will still not touch each other.

[0207] When the knob 5 is rotated to the initial state (the initial state of the knob 5 is shown in Figure 1a), the 5mg medicine pit 1604 and the 10mg medicine pit 1603 will be rotated back to the positions of the two first flow channel openings 903 and the second flow channel opening 904 of the flow channel lower component 9 (as shown in Figure 38, Figure 38 is a top view, when the knob 5 is rotated to the initial position, the first flow channel opening 903 is aligned with the 10mg medicine pit 1603, and the second flow channel opening 904 is aligned with the 5mg medicine pit 1604), waiting for the patient to inhale.

[0208] FIG38 also illustrates the movement paths (dashed lines) of the 5mg and 10mg drug wells 1604 and 1603 during the 90-degree rotation of the knob 5. As shown in FIG38 , these two independent drug well movement paths do not interfere with each other, thus ensuring that the selected path scheme is feasible in this embodiment of the invention.

[0209] In the present invention, the flow channel space of the dual-reservoir powder aerosol device (the space in which drug particles fly when delivered from the powder aerosol device) is composed of an upper flow channel component 7, a middle flow channel component 8 and a lower flow channel component 9, and the assembly relationship diagram of the three is shown in Figure 46.

[0210] The middle component 8 of the flow channel is fixed by cooperating with the latches 9001 to 9005 on the lower component 9 of the flow channel through the latch holes 801 to 805 respectively, while the upper component 7 of the flow channel is fixed by cooperating with the latch holes 806 to 808 of the middle component 8 of the flow channel through the latch holes 701 to 703 (the appearance of the upper component 7 of the flow channel is shown in Figure 47).

[0211] The effect after assembly of the upper flow channel component 7, the middle flow channel component 8 and the lower flow channel component 9 is shown in Figure 48. The three constitute a first space channel 7893 and a second space channel 7894 for the flight of drug particles from the 10 mg drug pit 1603 and the 5 mg drug pit 1604 respectively. The former is for the flight of drug particles from the 10 mg drug pit 1603, and the latter is for the flight of drug particles from the 5 mg drug pit 1604, as shown in Figure 49 (Figure 49 is a half-section view).

[0212] In order to fix the flow channel lower member 9 and make the flow channel lower member 9 fit more closely with the turntable 16, the transmission shaft 1702 above the transmission pawl 17 is inserted into the center hole 906 of the flow channel lower member 9 (the assembly method is shown in Figure 41, and the appearance of the flow channel lower member 9 is shown in Figures 39 and 40), so that the flow channel lower member 9 is coaxially matched with the turntable 16, the vibration tooth 15, the transmission cylinder 13 and the transmission pawl 17 (as shown in Figure 36). This is because the transmission gear 1705 of the transmission pawl 17 is inserted into the circular hole 11 of the transmission cylinder 13. 305 (as shown in Figures 18, 20 and 22), the transmission pawl 17 and the transmission cylinder 13 are coaxial; and because the guide rail 1701 of the transmission pawl 17 is inserted into the slot 1501 of the vibrating tooth 15 (as shown in Figures 20, 21 and 23), the transmission pawl 17 is coaxially matched with the vibrating tooth 15; and because the transmission shaft 1702 of the transmission pawl 17 is inserted into the matching hole 1606 of the turntable 16, the transmission pawl 17 is coaxially matched with the turntable 16 (as shown in Figures 28 and 30).

[0213] Therefore, when the flow channel lower component 9 is coaxially matched with the rotary disk 16 , it is also coaxially matched with the vibration teeth 15 , the transmission cylinder 13 and the transmission pawl 17 at the same time.

[0214] At the same time, the edge 301 of the shell 3 exerts a downward pressure on the edge 907 of the flow channel lower member 9, so that the flow channel lower member 9 can be tightly attached to the turntable 16. The shell 3 itself realizes the preliminary fixation of the shell 3 and the lower shell 19 by inserting the buckle 302 into the fixed card slot 1902 at the rear of the lower shell 19 (the appearance of the shell 3 is shown in Figures 42 and 43). Secondly, the shell 3 and the lower shell 19 are completely fixed by inserting the device suction nozzle 1 (the insertion direction of the device suction nozzle 1 is shown in Figure 44). The state after complete fixation is shown in Figure 45 (Figure 45 is a cross-sectional view, and it can be seen that the edge 301 of the shell 3 presses the flow channel lower member 9 and the lower shell 19). When the flow channel lower member 9 is fixed, the flow channel middle member 8 and the flow channel upper member 7 are also fixed.

[0215] At this point, the main body of the dual-reservoir device is installed, and the appearance of the main body is shown in FIG50 , which is the state of the dual-reservoir powder aerosol device during filling.

[0216] Figure 51 shows the installation position and orientation of the medicine barrel cover 18 (indicated by the arrow in the figure). The function of the medicine barrel cover 18 is to protect the powder stored in the first medicine storage barrel 901 and the second medicine storage barrel 902 from leaking. After the medicine barrel cover 18 is installed, the device cover 2 is finally installed to complete the assembly of the dual-reservoir powder inhaler device. The final device appearance is shown in Figure 52.

[0217] It should be noted that the guide rail 1701 of the transmission pawl 17 in the technical solution of the present invention is shaped like a square, and the corresponding slot 1501 of the vibrating tooth 15 is also shaped like a square. The purpose of adopting this structural design is to allow the transmission pawl 17 to rotate with the vibrating tooth 15, and when the transmission pawl 17 is not rotating, the vibrating tooth 15 can move up and down within a certain small range along the guide rail 1701.

[0218] In practical applications, the shapes of the guide rail and the slot are not limited to the letter "1" but may also be a cross or a cross-shaped shape.

[0219] This embodiment adopts a straight design because in the actual operation of the first mold and 3D printing, a straight guide rail has the best effect. The friction force on the vibrating teeth 15 during the up and down movement is relatively small and is not easy to get stuck.

[0220] It should be noted that, in the present invention, the rotation angle of the knob 5 is limited to 90 degrees. During the back and forth rotation of the knob 5, the components that rotate synchronously with the knob 5 from beginning to end are: the turntable 16 and the counter cover 12.

[0221] The matching hole 1606 on the rotating disk 16 is for inserting the transmission shaft 1702 on the transmission pawl 17. At the same time, the transmission shaft 1702 on the transmission pawl 17 is also inserted into the center hole 906 of the flow channel lower component 9, and the center hole 906 of the flow channel lower component 9 is concentric and coaxial with the matching hole 1606 on the rotating disk 16.

[0222] The transmission shaft 1702 on the transmission pawl 17 is coaxial and collinear with the transmission gear 1705, and the axis is perpendicular to the plane where the pawl 1704 is located. There are four pawls 1704 evenly distributed around the transmission shaft 1702, at 90-degree intervals. The structure of the transmission pawl 17 is shown in Figures 20 and 21.

[0223] The 10mg and 5mg wells 1603 and 1604 on turntable 16 align with drug storage spaces 1692 and 1691, respectively. In practice, the alignment of each well with each drug storage space can be determined based on practical circumstances, such as the distribution of the filling line. Because turntable 16 is circular in shape, its latches 1601 and 1602 are not front-to-back.

[0224] The two medicine wells 10mg medicine well 1603 and 5mg medicine well 1604 on the turntable 16 are used to carry a medicine prescription with a dosage of 10mg and a medicine prescription with a dosage of 5mg respectively. In practice, the size of the medicine wells can be adjusted according to the situation.

[0225] The turntable vibrating teeth 1605 below the turntable 16 are undulating and evenly distributed at ninety degrees around the matching hole 1606, as shown in FIG28 .

[0226] Similarly, the teeth 1502 on the vibrating tooth 15 are also evenly distributed at ninety degrees around the slot 1501 .

[0227] The tooth profile diagram of the two vibrating teeth is shown in FIG33 , where the direction of the arrow is the movement direction of the two vibrating teeth when the knob 5 is rotated.

[0228] When the knob 5 is rotated for the first time, the tooth profile 1502 on the vibrating tooth 15 and the rotating disk vibrating tooth 1605 below the rotating disk 16 move in a relative sliding-separation-knocking engagement manner. When the knob 5 is rotated for the second time, the tooth profile 1502 on the vibrating tooth 15 engages with the rotating disk vibrating tooth 1605 below the rotating disk 16 and rotates coaxially (without separation).

[0229] The angle between the two medicine wells on the turntable 16, the 10mg medicine well 1603 and the 5mg medicine well 1604, is 180 degrees. Correspondingly, the angle between the line connecting the first medicine storage barrel 901 and the second medicine storage barrel 902 is also 180 degrees. That is, the angle between the line connecting the 10mg medicine well 1603 and the 5mg medicine well 1604 and the line connecting the first medicine storage barrel 901 and the second medicine storage barrel 902 is 90 degrees (as shown in FIG57 ). This angle is designed based on the rotation angle of the knob 5. When the knob 5 is rotated 90 degrees counterclockwise as shown in FIG57 , the 10mg medicine well 1603 will be transferred to the bottom of the second medicine storage barrel 902, and the 5mg medicine well 1604 will be transferred to the first medicine storage barrel 901, completing the divided dose of the corresponding medicine wells.

[0230] Furthermore, the direction shown in FIG. 1 a and FIG. 1 b is facing the patient, and the direction in which the knob 5 rotates is 90 degrees to the right facing the patient. This direction is the rotation direction (operation direction) of the knob 5 in this embodiment.

[0231] The function of the cover 20 is to provide a preliminary positional limit for the vibrating tooth 15. During installation, the vibrating tooth 15 may be pushed out of the transmission cylinder 13 by the elastic force of the compression spring 14, causing the slot 1501 to disengage from the guide rail 1701, making it difficult to position the vibrating tooth 15 during installation. Therefore, the cover 20 is designed to facilitate installation of the dual-reservoir powder aerosol device.

[0232] The transmission cylinder 13 is fixed by four clamping blocks 1301 being clamped into the positioning block 1904 of the lower housing 19. In practice, if for cost considerations, the transmission cylinder 13 and the lower housing 19 can be made into one component.

[0233] There is a square groove 102 on the inner side of the device nozzle 1 for the clamping and fixing of the flow channel front edge 781.

[0234] In addition, there are corresponding slots 103 on both sides of the inner side of the device nozzle 1, which are used to cooperate with the nozzle clips 305 on both sides of the shell 3 to fix the nozzle. When the nozzle is installed, it will wrap around the leading edge 781 of the flow channel upper component 7 and the flow channel middle component 8.

[0235] The transition gear 11 is a two-layer gear, wherein the lower gear 1101 and the gear teeth 1001 inside the counter 10 are meshed with each other, and the upper gear 1102 and the transmission gear 1705 below the transmission pawl 17 are meshed with each other.

[0236] The circular hole 1305 in the middle of the transmission cylinder 13 is for the transmission gear 1705 to pass through. When the transmission pawl 17 is aligned with the pawl groove 1303 and inserted, the transmission gear 1705 below the transmission pawl 17 will pass through the circular hole 1305.

[0237] When the transmission cylinder 13 is fixed into the lower housing 19 , the transmission gear 1705 below the transmission pawl 17 is exposed outside the transmission cylinder 13 and can therefore mesh with the upper gear 1102 of the transition gear 11 .

[0238] There is a snap hole 1202 on the counter cover protrusion 1201 of the counter cover 12, which can be used for the snaps 1601 and 1602 on both sides of the turntable 16 to be snapped in. When snapped in, there are two concave grooves 1205 on the counter cover protrusion 1201, which can support and limit the cantilever 1607 and cantilever 1608 on the turntable 16.

[0239] There are two buckles 2001 on both sides of the cover 20, which are semicircular in shape (as shown in Figure 59) and are snapped into the buckle holes 1302 of the transmission cylinder 13 to fix the cover 20.

[0240] The cover 20 can play a preliminary role in limiting the vibrating teeth 15 that are subjected to the elastic force of the compression spring 14 .

[0241] The flow channel assembly consisting of the flow channel upper component 7, the flow channel middle component 8 and the flow channel lower component 9 has an air inlet 7891 and an air inlet 7892 (as shown in Figure 48) for the patient's inspiratory airflow to enter the flow channel, thereby achieving the delivery and entrainment of drug particles.

[0242] The upper cover 2 of the device cooperates with the upper cover buckles 303 on the shell 3 through the buckle holes 201 to achieve a tight buckle fit between the upper cover 2 of the device and the shell 3.

[0243] According to the knob rotation direction of Figure 1b, the rotation direction of the counter 10 is consistent with the direction of the arrow marked in Figure 12 (counterclockwise). A limit block 504 is set in the knob 5 (as shown in Figure 4), which can limit the rotation of the counter 10. When the counter 10 rotates to the specified number of times, it will be blocked by the limit block 504.

[0244] The rotation angle of each suction set by the counter 10 is 5 degrees, and the corresponding rotation angle of the transmission gear 1705 under the transmission pawl 17 is 90 degrees (based on the rotation angle setting of the knob 5 operation).

[0245] In actual situations, the number of teeth of the transition gear 11 and the gear teeth 1001 inside the counter 10 can be changed according to needs to change the rotation angle of the counter 10.

[0246] Because the direction of the transmission gear 1705 under the transmission pawl 17 needs to be considered when installing and inserting the gear, a positioning point 1703 is provided on the pawl 1704 on the transmission pawl 17. The function of this positioning point is installation positioning. During installation, it should be ensured that the positioning point is facing the direction of the suction nozzle edge 1905.

[0247] To facilitate gear installation, a positioning hole 1103 is provided on the transition gear 11. During installation, first place the counter 10 into the knob 5. Then, rotate the counter 10 to its initial position, allowing the top block 1002 below the counter 10 to abut against the limit block 504 in the knob 5 as a reference position. Then, align the positioning hole 1103 on the transition gear 11 with the counting positioning hole 1003 on the counter 10, and insert the transition gear 11 into the gear shaft hole 503 in the knob 5 to complete the installation.

[0248] The first medicine storage barrel 901 and the second medicine storage barrel 902 of the runner lower member 9 are in a two-way form, and this design is to facilitate demoulding during injection molding. Only when the runner lower member 9 is fitted with the rotating disk 16, the medicine storage space 1691 and the medicine storage space 1692 are formed.

[0249] Example:

[0250] A. Gear meshing scheme:

[0251] In this embodiment, the transmission gear 1705 below the transmission pawl 17 rotates at an angle of 90 degrees, which is designed based on the rotation limit angle of the knob 5 being 90 degrees, and the single (single suction) rotation angle of the counter 10 is 5 degrees.

[0252] Based on the gear transmission theorem, the rotation angle of a gear is inversely proportional to the number of teeth of the gear. The ratio of the rotation angle between the transmission gear 1705 and the gear teeth 1001 of the counter 10 is 18:1 according to the above description, that is, the gear tooth ratio is 1:18.

[0253] Since the number of teeth is relatively large, if no transition gear design is adopted, the outer diameter of the counter 10 will be very large, thereby affecting the overall size of the powder aerosol device.

[0254] Therefore, a transition gear 11 is added to the dual-reservoir powder aerosol device, and the transition gear 11 is divided into an upper gear 1102 and a lower gear 1101 (as shown in FIG. 58 ).

[0255] Assuming that the speed (rotation angle) and number of teeth of transmission gear 1705 are w1 and n1 respectively, the speed (rotation angle) and number of teeth of counter 10 are w4 and n4 respectively, the speed and number of teeth of upper gear 1102 are w2 and n2 respectively, and the speed and number of teeth of lower gear 1101 are w3 and n3 respectively, the following relationship can be obtained:

[0256] Since the upper gear 1102 and the lower gear 1101 are coaxial and integral, n2 = n3.

[0257] The above is the requirement for the number of teeth of the four gears to be able to count normally in this embodiment.

[0258] The meshing condition of the four gears in the present invention is shown in FIG61 .

[0259] The pitch circles of the four gears in the figure are tangent to each other, so the pitch circle diameters have the following relationship: m4n4=m1z1+m2z2+m3z3

[0260] Among them, m1, m2, m3 and m4 are the modules of the transmission gear 1705, the upper gear 1102, the lower gear 1101 and the gear tooth 1001 respectively.

[0261] Based on the gear meshing theorem, the modules of two meshing gears must be equal, that is, m1 = m2, m3 = m4. Therefore, by transforming the above formula, we can get: m4(z4-z3) = m1(z1+z2)

[0262] Based on the above two relationship equations and taking into account the assembly between the parts in this embodiment, the specific information of the four gears in this embodiment is as follows:

[0263] B. Shotweight experiment of dual reservoir device:

[0264] In this embodiment, two different prescriptions were used to fill the two medicine storage barrels of the double reservoir respectively, and a shotweight test was performed.

[0265] The test involves connecting the powder inhaler device to a specific fine powder collector via a rubber adapter. The device is then triggered to enter the standby state for inhalation. The drug is then extracted using a vacuum pump system with an adjustable flow rate. The drug dose delivered per single inhalation is calculated by measuring the weight difference between the device before and after weighing.

[0266] This experiment is used to examine whether the powder inhaler device can deliver the required single-inhalation drug dose according to the established drug crater size.

[0267] In this embodiment, the sizes of the two drug wells are 5 mg and 10 mg respectively. Therefore, theoretically, the dose separated from the drug storage barrel and delivered by the device should be 15 mg.

[0268] In this study, two different formulations were used to investigate the delivered dose over 30 puffs:

[0269] Recipe 1: Two commonly used commercially available lactose carriers, Lactohale 100 (manufacturer: DFE Pharma) and Inhalec 70 (manufacturer: Meggle), were mixed without the addition of the API to create a model drug formulation (without the API). The mixer used was a Turbula 3D mixer.

[0270] The shotweight test results of the pure lactose formulation are shown in FIG62 . As can be seen from the figure, the average delivered dose is 15.23 mg and the RSD is 6.25%.

[0271] Prescription 2: Two commonly used lactose carriers on the market, model numbers Lactohale 100 (manufacturer: DFE Pharma) and Inhalec 70 (manufacturer: Meggle), are used. After adding the API, the mixture is mixed to form a prescription. The mixer used is a Turbula three-dimensional mixer.

[0272] The shotweight test results of the lactose + API formulation are shown in FIG63 . As can be seen from the figure, the average delivered dose is 13.72 mg and the RSD is 9.12.

[0273] According to the above-mentioned shotweight experimental results, the RSDs of the two formulations within the delivery range of 30 inhalations were both less than 10%. In contrast, when the formulation contained the API, the RSD of the delivered dose of the formulation was higher than that of the formulation without the API.

[0274] This is because for powder inhalers (traditional powder inhalers, excluding new powder inhalers such as macromolecule biopharmaceuticals and antibiotics), most APIs require some degree of micronization. Micronized APIs are prone to generating static electricity during the mixing process with the carrier lactose. This static electricity can increase the dose variation delivered within the device.

[0275] In addition, there is a certain difference in the average delivered dose of the two formulations. For the formulation without API, the delivered dose is higher than that of the formulation with principle drug. This is because when API is mixed into the formulation, the overall fluidity of the formulation will decrease (the two lactose used in this experiment are both large-particle sieved lactose with good fluidity performance). At the same time, the addition of API will also make the formulation as a whole more susceptible to static electricity due to interference from external factors, such as friction between particles and the flow channel wall during the delivery process. All of the above situations will lead to a decrease in the delivered dose.

[0276] In summary, the key technical points of the technical solution of the present invention are as follows:

[0277] 1) The dual-reservoir powder inhaler device described in the present invention, as a novel type of powder inhaler device, can simultaneously store two different formulations while ensuring that the two formulations do not interfere with each other during storage and dosing.

[0278] In this embodiment of the present invention, the angle between the first medicine storage barrel 901 and the second medicine storage barrel 902 in the spatial arrangement is 180 degrees, and the corresponding angle between the first flow channel opening 903 and the second flow channel opening 904 is 90 degrees (as shown in Figures 38 and 57). This angle is determined based on the operating rotation angle of the knob 5.

[0279] 2) The shape and structural design of the turntable 16.

[0280] It is particularly pointed out that for the convenience of installation, the turntable 16 is designed with a buckle 1601 and a buckle 1602. Its appearance is "semi-circular" and is used to be snapped into the buckle hole 1202 on the protrusion 1201 of the counter cover. After being snapped in, the turntable 16 can rotate coaxially and in the same direction as the counter cover 12.

[0281] 3) The distribution of the medicine wells on turntable 16 corresponds to the distribution of the first medicine storage barrel 901 and the second medicine storage barrel 902. In the initial state, the two medicine wells on turntable 16: 10mg medicine well 1603 and 5mg medicine well 1604 correspond to the first flow channel opening 903 and the second flow channel opening 904, respectively. That is, the angle between the line connecting the two and the line connecting the first medicine storage barrel 901 and the second medicine storage barrel 902 is 90 degrees. After rotation, the 10mg medicine well 1603 and the 5mg medicine well 1604 correspond to the second medicine storage barrel 902 and the first medicine storage barrel 901, respectively.

[0282] 4) The dual-reservoir powder inhaler device of the present invention utilizes rotating disks to achieve dosing. By rotating disk 16 90 degrees back and forth, the drug powder in first and second drug storage barrels 901 and 902 is dispensed into 10mg and 5mg wells 1603 and 1604, respectively. The powder in these two wells is then transferred to first and second flow channels 903 and 904 for delivery. During this process, the two prescription powders remain out of contact (prior to delivery).

[0283] 5) The transmission structure design consisting of the transmission cylinder 13, transmission pawl 17, vibration teeth 15, compression spring 14 and cover 20 can convert the reciprocating rotation of the turntable 16 into a unidirectional rotation of the transmission gear 1705 under the transmission pawl 17.

[0284] In this embodiment, the transmission cylinder 13 and lower housing 19 are separate. However, in actual projects, the transmission cylinder 13 and lower housing 19 can be made into a single component to save component costs. The cover 20 adopts a snap-fit ​​design, which serves to limit the vibrating teeth 15 under the elastic force of the compression spring 14. The vibrating teeth 15 in the transmission structure are used to mesh with the turntable vibrating teeth 1605 below the turntable 16.

[0285] 6) The appearance and structural design of the transmission pawl 17 are the key to realizing the function of the transmission structure. The guide rail 1701 on the transmission pawl 17 serves as the guide rail for the reciprocating motion of the vibrating tooth 15. Its shape is "straight" in this embodiment, but it is not limited to "straight". It can also be "cross" or "cross cross". The "straight" shape is chosen because in the prototype and 3D printing experiments, the friction received by the vibrating tooth 15 during the reciprocating motion is the smallest. The pawls 1704 of the transmission pawl 17 are evenly distributed around the transmission shaft 1702, with an interval of 90 degrees (as shown in Figure 21). This structure can ensure that the transmission pawl 17 can only rotate in one direction when it rotates. The 90-degree evenly distributed interval is based on the rotation angle of the knob 5.

[0286] 7) In the technical solution of the present invention, the transmission gear 1705 below the transmission pawl 17 is used to engage with the transition gear 11 in the counting module. The transmission gear 1705 drives the unidirectional rotation of the transition gear 11 with the unidirectional rotation of the transmission pawl 17, thereby realizing the unidirectional rotation of the counter 10 below.

[0287] 8) The device is operated by rotating the knob 5 back and forth approximately 90 degrees, and the device needs to be held vertically during operation.

[0288] The above embodiments are merely used to explain and illustrate the present invention, and are not intended to limit the technical solutions of the present invention. Those skilled in the art should recognize that any changes or modifications to the above embodiments will fall within the scope of protection required by the claims of the present invention as long as they are within the spirit of the present invention.

[0289] Industrial Applicability

[0290] The technical solution of the present invention stores two drug prescriptions separately in two drug storage barrels, delivers them to the dispersion chamber through their respective separate medicine pits and separate delivery channels, and then delivers them to the outlet through the suction nozzle channel; two different preparation prescriptions can be stored at the same time, while ensuring that the two prescriptions will not interfere with each other during the storage and dosage process; during the operation of the device, there will be corresponding operation prompts to tell the user that the operation is in place or correct; there is a corresponding counter to tell the patient how much remaining dose is in the device; the drugs in the two drug storage barrels are removed from the drug storage barrels, the single inhalation dose is distributed, and then delivered to the dispersion chamber and delivered to the outlet at the same time, so as to ensure that the drugs of the two drug prescriptions can be dispersed and delivered to the patient's body at the same time.

[0291] The invention can be widely used in the field of design and manufacture of powder aerosol devices.

Claims

1. A dual-reservoir powder aerosol device, comprising at least a medicine storage barrel, a medicine pit, a delivery channel, a dispersion chamber, a dosing structure, a knob located on the upper part of the device, a core transmission structure located inside the device, a turntable, a vibrating tooth and a counting module; wherein: The dual-reservoir powder aerosol device comprises at least two medicine storage barrels; The two medicine storage barrels are a first medicine storage barrel and a second medicine storage barrel; A first medicine pit and a second medicine pit are respectively provided below the first medicine storage barrel and the second medicine storage barrel; Two separate delivery channels are provided; the two separate delivery channels are a first delivery channel and a second delivery channel; One end of the first delivery channel is arranged corresponding to the first drug pit, and the other end is connected to the dispersion cavity; The second delivery channel is arranged corresponding to the second drug pit, and the other end is connected to the dispersion cavity; The two drug prescriptions are stored separately in two drug storage cartridges, and a "turntable" type dosing structure / dosing method is adopted. After being delivered to the same dispersion cavity through separate drug pits and separate delivery channels, they are delivered to the outlet through the suction nozzle channel; The process of dispensing the drugs in the two drug storage barrels from dispensing the single inhalation dose to delivering them to the dispersion chamber and delivering them to the outlet is carried out simultaneously, so as to ensure that the two doses of drugs can be dispersed and delivered to the patient at the same time; The dual-reservoir powder aerosol device ensures that two kinds of drug powders are stored in their respective drug storage barrels during the drug storage process, and will not come into contact with each other; The device operation method adopted is achieved by turning the knob back and forth about 90 degrees; When operating the dual-reservoir powder inhaler device, first turn the knob about 90 degrees. When it is turned to 90 degrees, a click sound will be heard inside the device, indicating that the knob has been turned to the right position. Then turn the knob back to the initial position. At this time, a click sound will be heard inside the device again to prompt that the knob has been turned to the right position, thereby completing the action of dispensing a single inhalation dose of medicine from the drug storage cartridge. At the same time, the counter counts once and the number on the surface of the counter can be read through the counting window. After operating the knob, single inhalation doses of two required drugs can be separated from the two drug barrels at one time.

2. The dual-reservoir powder aerosol device according to claim 1, characterized in that The flow channel space of the double-reservoir powder aerosol device is composed of an upper flow channel component, a middle flow channel component and a lower flow channel component.

3. The dual-reservoir powder aerosol device according to claim 2, characterized in that The upper flow channel component, the middle flow channel component and the lower flow channel component constitute a first space channel and a second space channel for drug particles from the first drug pit and the second drug pit to fly respectively. The first space channel is for drug particles from the first drug pit to fly, and the second space channel is for drug particles from the second drug pit to fly.

4. The dual-reservoir powder aerosol device according to claim 3, characterized in that The flow channel upper component, the flow channel middle component and the flow channel lower component are fixed as a whole.

5. The dual-reservoir powder aerosol device according to claim 4, characterized in that A turntable is provided; the turntable and the lower member of the flow channel are in a fitted state after being assembled; A first medicine pit and a second medicine pit are arranged on a surface of the rotating disk facing the lower member of the flow channel; Two medicine storage spaces are formed between the rotating disk and the first medicine storage barrel and the second medicine storage barrel respectively; When the knob is turned about 90 degrees, the two medicine pits on the turntable will be simultaneously rotated to the bottom of the first medicine storage barrel and the second medicine storage barrel. When the two medicine pits are rotated to the right position, the powders in the first medicine storage barrel and the second medicine storage barrel will be discharged from the first medicine storage space and the second medicine storage space to the first medicine pit and the second medicine pit respectively, and the divided doses of the corresponding medicine pits will be completed at the same time. At this time, the powders in the two medicine pits will still not touch each other; When the knob is rotated back to the initial state, the second medicine pit and the first medicine pit will be simultaneously rotated back to the positions of the two first flow channel openings and the second flow channel openings of the flow channel lower component, waiting for the patient to inhale.

6. The dual-reservoir powder aerosol device according to claim 5, characterized in that A turntable vibration tooth is arranged below the turntable, and the turntable vibration tooth is up and down and evenly distributed at 90 degrees around the matching hole; A vibrating tooth is arranged below the rotating disk, and the teeth on the vibrating tooth are evenly distributed at 90 degrees around the slot; When the knob is turned for the first time, the motion between the tooth profile on the vibrating tooth and the vibrating tooth of the turntable below the turntable is relative sliding-separation-knocking engagement; When the knob is turned for the second time, the teeth on the vibrating teeth mesh with the vibrating teeth of the turntable below the turntable, rotating coaxially without separation; Since the two drug prescriptions loaded in the first medicine storage barrel and the second medicine storage barrel may have different fluidities, a double-vibration knocking vibration mode is adopted to ensure to the greatest extent that the two prescriptions with different fluidities can be accurately dispensed into their respective medicine pits.

7. The dual-reservoir powder aerosol device according to claim 1, characterized in that The core transmission structure is composed of a transmission cylinder, a compression spring, a vibration tooth, a transmission pawl and a cover. The turntable rotates in the same direction as the knob, so that the turntable can rotate back and forth 90 degrees while driving the counter to rotate in one direction.

8. The dual-reservoir powder aerosol device according to claim 1, characterized in that The counting module of the dual-reservoir powder aerosol device is composed of a knob, a counter, a transition gear and a counter cover; The counter cover and the knob are matched with each other through protrusions and steps. The steps support the counter cover, and the protrusions around the inner side of the knob limit the counter cover, so that the counter cover can rotate in the same direction and at the same angle as the knob.

9. The dual-reservoir powder aerosol device according to claim 1, characterized in that The dual-reservoir powder aerosol device can store at least two different formulations at the same time, while ensuring that the two formulations do not interfere with each other during storage and dosing; The dosing structure / dosing method of the dual-reservoir powder aerosol device is realized by rotating a turntable; the turntable rotates back and forth 90 degrees to respectively dispense the drug powders in the first drug storage barrel and the second drug storage barrel into the first drug pit and the second pit, and then the powders in the two drug pits are respectively transferred to the first flow channel opening and the second flow channel opening for delivery; before being delivered, the two prescription powders always remain in a non-contact state.

10. The dual-reservoir powder aerosol device according to claim 1, characterized in that During operation, the dual-reservoir powder aerosol device needs to be held vertically to achieve its function normally.

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