A dual-reservoir powder aerosol device

Abstract

A dual-reservoir powder inhaler device belongs to the field of drug delivery devices. A first and a second medicine storage barrel are provided; a first and a second medicine pit are respectively and correspondingly provided below the two medicine storage barrels; a first and a second delivery channel are provided; one ends of the first and second delivery channels respectively correspond to the first and second medicine pits, and the other ends are connected to a dispersion chamber; two drug prescriptions are separately stored in the two medicine storage cylinders, a "rotary disk" type dosing structure is adopted, and they are respectively delivered to the same dispersion chamber through separate medicine pits and separate delivery channels, and then are delivered to the outlet through a nozzle channel; the process of the drugs in the two medicine storage barrels being discharged from the medicine storage barrels, dispensing a single inhalation dose, and then being delivered to the dispersion chamber and then to the outlet is carried out simultaneously to ensure that the drugs of the two doses can be dispersed and delivered to the patient's body at the same time. It can ensure that the two prescription drugs do not interfere with each other during the storage and dosing processes. It can be widely used in the design and manufacturing fields of powder inhaler devices.

Description

Technical Field

[0001] The present invention belongs to the field of devices for introducing a medium into the human body, and particularly relates to an inhalable drug delivery device. Background Art

[0002] A dry powder inhaler (DPI) is a special dosage form that disperses and depolymerizes drug powders into particles with appropriate particle sizes through a specific drug delivery device (without propellants) and delivers them to the lungs of a patient after the patient's active breathing. It belongs to one of the inhaled preparations.

[0003] This dosage form has the following advantages:

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

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

[0006] 3) Compared with an aerosol (Pressurized Meter Dose Inhaler, PMDI), which is also an inhaled preparation, the dry powder inhaler atomizes and disperses the drug through the airflow of the patient's active inhalation. Therefore, the synergy between the device and the patient is better;

[0007] 4) Compared with nebulized inhalation solutions or suspensions, which are also inhaled preparations, the dry powder inhaler device is smaller in volume and more portable than a nebulizer and can be placed in the patient's pocket for easy carrying;

[0008] 5) Compared with liquid preparations, the drug in the dry powder inhaler exists in a solid form and is more stable.

[0009] Based on the above advantages, the dry powder inhaler has currently become a research focus at the forefront in the field of inhaled preparations at home and abroad.

[0010] Traditional inhaled preparations are commonly used to treat asthma and chronic obstructive pulmonary disease (COPD). The most common drugs include the following: 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), etc.

[0011] According to foreign clinical studies, the triple therapy of inhaled corticosteroids, long-acting muscarinic antagonists (LAMA), and long-acting β2-agonists (LABA) can effectively treat chronic obstructive pulmonary disease (COPD), especially for severe patients. Taking the research of the Klaus.F team in Germany as an example, through the comparison of triple prescriptions of two different doses of corticosteroids, it was found that the triple therapy of budesonide (320 micrograms or 160 micrograms) + glycopyrronium + formoterol twice a day can significantly reduce the exacerbation rate of severe COPD patients compared with glycopyrronium + formoterol or budesonide + formoterol.

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

[0013] However, it is found in actual operation that there are quite a few challenges in directly mixing the three active ingredients with lactose:

[0014] 1) First, it is necessary to ensure that there are no raw material and excipient compatibility problems between the three active ingredients and the excipient lactose, as well as between the active ingredients.

[0015] 2) Secondly, it is necessary to ensure that during the mixing process of the three active ingredients with the lactose carrier, they can all be evenly covered on the surface of the lactose carrier and at the same time achieve a qualified mixing uniformity.

[0016] 3) It is necessary to ensure that during the delivery process, the three active ingredients can all smoothly fall off from the surface of the lactose carrier, so as to achieve a qualified aerodynamic particle size distribution.

[0017] Most of the common reservoir-type powder inhaler products on the market currently are in the design form of "single reservoir", that is, the powder inhaler device only contains a single medicine storage barrel (for storing drugs) and a single medicine pit (for dispensing a single inhalation dose from the medicine storage barrel). The supporting flow channel system is also designed around the single reservoir: one medicine pit is equipped with one drug delivery channel and one 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 currently marketed reservoir-type powder inhaler products are of single reservoir design, the drive design of the "counter" is also carried out around a complete set of the single reservoir, that is, the dose index of the "counter" is for a single medicine pit.

[0018] The device design of the above single reservoir poses no major problems for most powder aerosol formulations, such as the delivery and dispersion of single-agent formulations (formulations containing only one active ingredient). Since the formulation as a whole contains only one active ingredient, there will be no compatibility problems or interference with other active ingredients. Moreover, the supporting device structures, such as the flow channels, counting structures, and dosing structures, are also customized and designed one-to-one for each individual formulation, with a high degree of mutual adaptability in function.

[0019] However, when the number of active ingredients in the formulation is two or more (the former is a compound formulation and the latter is a triple prescription formulation), if the above single reservoir device design is still adopted, the following problems may occur:

[0020] 1) First of all, the single reservoir design will impose great limitations on the selection of active ingredients. Because it is necessary to ensure that there are no compatibility problems between two or more active ingredients. If there are compatibility problems between the active ingredients and they are stored in the same storage barrel, once the storage time becomes longer, compatibility problems such as the mutual reaction between the active ingredients will occur. Specifically, the impurities in the formulation will increase correspondingly, and finally may exceed the standard range, which will have a great impact on the safety of the product (this problem is as described in 1.1 Technical Field).

[0021] 2) Secondly, as mentioned above, for formulations containing two or more active ingredients, since the binding force between each active ingredient and the lactose surface is more or less different, it is more difficult to simultaneously ensure that multiple active ingredients can be evenly coated and adhered to the lactose particle surface during the mixing process compared to single-agent formulations. During the above process, once the active ingredient particles fail to bind to the lactose surface, it will lead to the agglomeration of the active ingredient particles themselves (usually the particle size of the active ingredients used in inhaled powder aerosols is small and very prone to self-agglomeration), and then lead to the stratification between the active ingredient particles and the lactose carrier particles.

[0022] 3) Because of the differences in the binding force between different active ingredients and lactose, certain requirements will also be imposed on the dispersion ability of the device, because the designed device needs to simultaneously meet the dispersion and delivery of all active ingredients. Any modification or change to any one active ingredient will directly or indirectly affect one, two or more other active ingredients.

[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 the 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 chamber through their own independent drug delivery channels (the two drug prescriptions will not come into contact until before the dispersion chamber to avoid compatibility problems), and finally the two prescriptions meet and disperse in the dispersion chamber before being delivered together to the nozzle outlet.

[0024] In order to deliver and disperse complex triple-drugs and multiple drugs, GlaxoSmithKline of the United Kingdom has developed a new powder aerosol device that can accommodate triple-drug prescriptions, called the Easy-to-Dose Device. ), It is a vesicle-type powder inhaler device (a type of powder inhaler device, which stores the prescription separately in vesicles made of aluminum foil, and seals and rolls them into vesicle strips. When using it, the patient opens the lid of the device, thereby triggering the mechanical action in the device to tear the vesicle strip, and the drug flows out and is delivered with the patient's inhalation airflow). The basic idea is to mix one of the raw materials with lactose alone and fill it in a separate vesicle strip, and the other two raw materials are mixed with lactose together and filled in another vesicle strip. The three raw materials are basically not in contact before delivery, and only briefly contact for a few tenths of a second in the device flow channel during drug delivery, thereby avoiding the problem of compatibility of raw materials and excipients. The device can also deliver a prescription of a single raw material, specifically by using only the channel of one of the blister bags. While achieving the delivery of triple drugs, the device can also reduce the difficulty of formulation technology as much as possible. However, the number of parts of the device is relatively large (more than 22 parts, and a considerable part of the parts are counting device 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 its powder discharge design method of peeling off the vesicle strips. 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 aerosol device needs to meet the requirements of being small in size 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, and the dispersion ability of this type of dispersion channel is weak), which makes the dispersion of the device itself very insufficient.

[0027] Meanwhile, from the perspective of industrialization realization, the filling line used for the filling of the vesicle device requires complete "customized manufacturing". From the production of vesicle strips, to the filling of medicinal powders, to the sealing of vesicle strips, and finally to the automatic assembly into the device, the cost of the entire process is relatively high and generally unaffordable for ordinary enterprises. In addition, due to the limitation of the small filling volume of vesicle products (generally, small particle size lactose is used for vesicle products, and the administered dose is usually relatively small after conversion according to the mixing ratio of the active pharmaceutical ingredient and it), relatively high filling accuracy is also required for the filling equipment.

[0028] Based on this, the present invention provides a reservoir powder aerosol device containing two medicine storage cylinders (hereinafter referred to as double reservoirs), which splits the blending of three active pharmaceutical ingredients and lactose into the separate mixing of a certain active pharmaceutical ingredient and lactose, can reduce the difficulty of formulation mixing, and at the same time, for an active pharmaceutical ingredient that is unstable for a certain formulation or binds too tightly to lactose and requires special treatment, can reduce its influence on the other two active pharmaceutical ingredients. Summary of the Invention

[0029] The technical problem to be solved by the present invention is to provide a double reservoir powder aerosol device. It separately stores two drug prescriptions in two medicine storage cylinders, and respectively delivers them to the same dispersion chamber through separate medicine pits and separate delivery channels for dispersion, and then is delivered to the outlet through the nozzle channel; during the operation of the device, corresponding operation prompts will be provided 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 drug in its two medicine storage barrels is simultaneously carried out from the medicine storage barrel to the single inhalation dose of drug dispensing and then to the delivery to the dispersion chamber and then to the delivery to the outlet (also known as drug dispensing), dispersion and delivery processes to ensure that the drugs of the two doses can be simultaneously dispersed and delivered into the patient's body.

[0030] The technical solution of the present invention is: to provide a double reservoir powder aerosol device, which at least includes a medicine storage barrel, a medicine pit, a delivery channel, a dispersion chamber, a dose dividing structure, a knob located at the upper part of the device, a core transmission structure located inside the device, a turntable, a vibrating tooth, and a counting module; characterized in that:

[0031] The double reservoir powder aerosol device at least includes two medicine storage barrels;

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

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

[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 described first delivery channel is correspondingly arranged with the first medicine pit, and the other end is connected to the dispersion chamber;

[0036] The described second delivery channel is correspondingly arranged with the second medicine pit, and the other end is connected to the dispersion chamber;

[0037] Two drug prescriptions are separately stored in two medicine storage cylinders. Using a "rotary disk" type dosing structure / dosing method, through separate medicine pits and separate delivery channels, after being delivered to the same dispersion chamber, they are delivered to the outlet through the nozzle channel;

[0038] The process of the drugs in the two medicine storage barrels from being dosed and dispensed from the medicine storage barrels with a single inhalation dose to being delivered to the dispersion chamber and then to the outlet is carried out simultaneously to ensure that the drugs of the two doses can be dispersed and delivered to the patient's body at the same time;

[0039] During the process of storing drugs in the described dual-reservoir powder inhaler device, it is ensured that the two drug powders are stored in their respective medicine storage barrels and do not come into contact with each other;

[0040] The adopted device operation method is achieved by rotating the knob back and forth about 90 degrees;

[0041] When operating the dual-reservoir powder inhaler device, first rotate the knob about 90 degrees. When it reaches 90 degrees, a click sound will be heard inside the device, indicating that the knob has been rotated in place; secondly, then rotate the knob back to the initial state. At this time, a sound will be heard again inside the device to indicate that the knob has been rotated back in place, thus completing the action of dispensing the drug of a single inhalation dose from the medicine storage cylinder; at the same time, the counter counts one rotation, and the reading on the surface of the counter can be read through the counting window;

[0042] After operating the knob, it is possible to separately separate the single inhalation doses of the two required drugs from the two medicine barrels at one time.

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

[0044] Further, the upper flow channel component, the middle flow channel component, and the lower flow channel component form a first space channel and a second space channel for the drug particles respectively coming from the first medicine pit and the second medicine pit to fly. The first space channel is for the drug particles from the first medicine pit to fly, and the second space channel is for the drug particles from the second medicine pit to fly.

[0045] Specifically, the upper flow channel component, the middle flow channel component, and the lower flow channel component are fixed together as a whole.

[0046] Specifically, a rotary disk is provided; after the rotary disk and the lower flow channel component are assembled, they are in a fitting state;

[0047] On the side of the turntable facing the lower component of the flow channel, a first medicine pit and a second medicine pit are provided;

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

[0049] After the knob is rotated about 90 degrees, the two medicine pits on the turntable will be respectively rotated to the positions below the first medicine storage barrel and the second medicine storage barrel at the same time. When the two medicine pits reach the in-place position, the powders in the first medicine storage barrel and the second medicine storage barrel will be respectively and simultaneously dosed into the first medicine pit and the second medicine pit from the first medicine storage space and the second medicine storage space, and the dosing of the corresponding medicine pits will be completed at the same time. At this time, the powders in the two medicine pits still do not come into contact with each other;

[0050] When the rotary knob returns to the initial state, the second medicine pit and the first medicine pit will be simultaneously rotated back to the positions where the two first flow ports and the second flow ports of the lower component of the flow channel are located, waiting for the patient to inhale.

[0051] Furthermore, a turntable vibration tooth is provided below the turntable. The turntable vibration tooth is in a shape of undulating up and down and is evenly distributed at 90 degrees around the mating hole;

[0052] Below the turntable, a vibration tooth is provided, and the tooth shape on the vibration tooth is evenly distributed at 90 degrees around the slot hole;

[0053] When the knob is rotated for the first time, the movement between the tooth shape on the vibration tooth and the turntable vibration tooth below the turntable is relative sliding - separation - knocking engagement;

[0054] When the knob is rotated back for the second time, the tooth shape on the vibration tooth meshes with the turntable vibration tooth below the turntable, rotates coaxially and does not separate;

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

[0056] Specifically, the core transmission structure is composed of a transmission cylinder, a compression spring, a vibration tooth, a transmission pawl and a lid. The turntable rotates in the same direction as the knob, realizing the function of driving the counter to rotate unidirectionally while the turntable rotates back and forth at 90 degrees.

[0057] Specifically, the counting module of the double - reservoir powder aerosol device is jointly composed of a knob, a counter, an intermediate gear and a counter lid;

[0058] The cooperation between the counter lid and the knob is realized through a protrusion and a step. The step plays a role of supporting the counter lid, and the protrusions around the inner side of the knob play a role of limiting the counter lid, enabling the counter lid to rotate in the same direction as the knob by the same angle.

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

[0060] The dosing structure / dosing method of the dual-reservoir powder inhaler device is realized by the rotation of a turntable; through the 90-degree reciprocating rotation of the turntable, the drug powders in the first medicine storage barrel and the second medicine storage barrel are respectively dosed into the first medicine pit and the second pit, and then the powders in the two medicine pits are respectively transferred to the first fluid outlet and the second fluid outlet for delivery; before being delivered, the two prescription powders always remain in a non-contact state.

[0061] Specifically, during the operation process, the dual-reservoir powder inhaler device needs to be held vertically to normally realize its function.

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

[0063] 1. The dual-reservoir powder inhaler device described in the present invention can separately store two different formulation prescriptions (containing different active pharmaceutical ingredients) in two different medicine storage barrels, avoiding mutual contact, thereby avoiding the problem of excipient compatibility between different active pharmaceutical ingredients and excipients.

[0064] 2. For compound preparations and triple preparations, it is relatively difficult to mix two or three active pharmaceutical ingredients and lactose simultaneously; the dual-reservoir powder inhaler device described in the present invention can reduce the difficulty of the formulation process to a certain extent: for compound preparations, the two active pharmaceutical ingredients can be separately mixed with the lactose carrier, which is less difficult than mixing the two active pharmaceutical ingredients with lactose simultaneously; for triple preparations (containing three different active pharmaceutical ingredients), one of the less stable active pharmaceutical ingredients that is prone to react with the other two active pharmaceutical ingredients and is prone to tightly bind with lactose can be isolated and mixed with lactose alone, while allowing the other two active pharmaceutical ingredients to be mixed with lactose, and the difficulty is also lower than mixing the three active pharmaceutical ingredients simultaneously.

[0065] 3. The dual-reservoir powder inhaler device described in the present invention does not require prior activation operation of the dual-reservoir powder inhaler device before use. Compared with the Symbicort Turbuhaler device, unnecessary operations are reduced. This is because in the dual-reservoir powder inhaler device described in the present invention, during the 90-degree rotation of the medicine pit, it directly reciprocates between the medicine storage barrel and the fluid outlet, and the patient operates the device knob to directly dispense a single inhalation dose to the fluid outlet for inhalation.

[0066] 4. The dual-reservoir powder aerosol device described in the present invention adopts a snap structure in its design, such as the snap fit between the lid 20 and the drive cylinder 13 and the snap fit between the turntable 16 and the counter lid 12. These snap fits can make the installation of the dual-reservoir powder aerosol device much more convenient (reducing the spring force that is not conducive to installation generated by the deformation of the compression spring 14). At the same time, the design of the main body of the device of the present invention also facilitates filling.

[0067] 5. The dual-reservoir powder aerosol device described in the present invention adds an operation prompt sound for the knob in the operation design. When the patient rotates the knob twice, when the knob 5 is turned to the corresponding position, a "click" prompt sound will be emitted inside the device.

[0068] 6. After the previous operation, the sound structure that emits the "click" prompt sound can produce a vibration effect. Based on the operation design, the "click" prompt sound will sound twice, and at the same time, two vibrations will be generated, which can ensure to the greatest extent that the prescriptions with different fluidities stored in the two different medicine storage barrels can effectively fall into the medicine pits.

[0069] 7. In the design of the independent movement trajectories of the two independent medicine pits of the present invention, a 90-degree arc trajectory design is adopted, which can fundamentally avoid the interference problem of the two movement trajectories (the trajectory of the medicine pit moving from the medicine discharging port of the medicine storage barrel to the flow port after dispensing a single inhalation dose). And because the paths of the two independent medicine pits moving from the medicine discharging port of the medicine storage barrel to the flow port are independent of each other, it can better meet the advantage of "ensuring that there are no problems with the compatibility of the three active ingredients and the excipient lactose and between the active ingredients". BRIEF DESCRIPTION OF THE DRAWINGS

[0070] Figure 1a is a schematic diagram of the external shape of the device of the present invention;

[0071] Figure 1b is a schematic diagram of the external shape of the device of the present invention after the knob is rotated 90 degrees;

[0072] Figure 2 is a schematic cross-sectional structure diagram of the device of the present invention;

[0073] Figure 3 is a schematic external structure diagram of the knob of the present invention;

[0074] Figure 4 is a schematic top view structure diagram of the knob of the present invention;

[0075] Figure 5 is a schematic assembly effect diagram of the knob and the counter of the present invention;

[0076] Figure 6 The top view structure diagram of the assembly effect of the knob and the counter of the present invention;

[0077] Figure 7 is an exploded view of the knob and counter cover of the present invention;

[0078] Figure 8 is a schematic diagram of the external structure of the lower housing of the present invention;

[0079] Figure 9 is a side view of the lower housing of the present invention;

[0080] Figure 10 is a top view of the lower housing of the present invention;

[0081] Figure 11 is a schematic diagram of the assembly effect of the knob and the lower housing of the present invention;

[0082] Figure 12 is a top view of the assembly of the knob and the lower housing of the present invention;

[0083] Figure 13 is an exploded view of the assembly of the knob and the lower housing of the present invention;

[0084] Figure 14 is a three-dimensional view of the external appearance of the assembly of the knob and the lower housing of the present invention;

[0085] Figure 15 is a schematic diagram of the external structure of the core transmission structure of the present invention;

[0086] Figure 16 is an exploded view of the core transmission structure of the present invention;

[0087] Figure 17 is a three-dimensional structure schematic diagram of the transmission cylinder of the present invention;

[0088] Figure 18 is a schematic diagram of the top view structure of the transmission cylinder of the present invention;

[0089] Figure 19 is a schematic diagram of the sectional structure of the transmission cylinder of the present invention;

[0090] Figure 20 is a schematic diagram of the structure of the transmission pawl of the present invention;

[0091] Figure 21 is a schematic diagram of the top view structure of the transmission pawl;

[0092] Figure 22 is a schematic diagram of the cooperation between the transmission pawl and the transmission cylinder;

[0093] Figure 23 is a schematic diagram of the external structure of the vibration tooth;

[0094] Figure 24 is a sectional view of the transmission structure;

[0095] Figure 25It is an installation explosion diagram of the transmission structure and the counting structure;

[0096] Figure 26 It is a schematic diagram of the installation effect of the transmission structure and the counting structure;

[0097] Figure 27 It is a schematic diagram of the external structure of the turntable;

[0098] Figure 28 It is a schematic diagram of the bottom view external structure of the turntable;

[0099] Figure 29 It is a three-dimensional structure schematic diagram of the external shape of the counter cover;

[0100] Figure 30 It is a schematic diagram of the installation effect of the turntable after installation;

[0101] Figure 31 It is a sectional view of the installation effect of the turntable;

[0102] Figure 32 It is a schematic diagram of the separation structure of the vibrating teeth;

[0103] Figure 33 It is a schematic diagram when the vibrating teeth have relative displacement;

[0104] Figure 34 It is a schematic diagram of the structure of the vibrating teeth in the occluded and non-separated state;

[0105] Figure 35 It is a schematic diagram of the shaft hole fit between the vibrating teeth and the transmission ratchet pawl;

[0106] Figure 36 It is a sectional view of the medicine storage structure of the present invention;

[0107] Figure 37 It is a schematic diagram of the mutual position relationship when the medicine pit rotates to below the medicine barrel;

[0108] Figure 38 It is a schematic diagram of the state when two medicine pits are rotated back to the initial position;

[0109] Figure 39 It is a schematic diagram of the external structure of the lower member of the flow channel;

[0110] Figure 40 It is a side view of the external shape of the lower member of the flow channel;

[0111] Figure 41 It is a schematic diagram of the assembly method of the lower member of the flow channel;

[0112] Figure 42 It is a sectional view of the structure of the housing;

[0113] Figure 43 It is a three-dimensional structure schematic diagram of the housing;

[0114] Figure 44 It is a schematic diagram of the installation and fixing direction of the suction nozzle;

[0115] Figure 45 It is a schematic diagram of the fixing effect of the suction nozzle;

[0116] Figure 46 It is an exploded view of the upper component, middle component and lower component of the flow channel;

[0117] Figure 47 It is a schematic diagram of the external structure of the upper component of the flow channel;

[0118] Figure 48 It is a schematic diagram of the external structure after the flow channel is assembled;

[0119] Figure 49 It is a schematic diagram of the structure of the double-particle channel of the present invention;

[0120] Figure 50 It is a schematic diagram of the external appearance of the device main body of the present invention;

[0121] Figure 51 It is a schematic diagram of the assembly of the cartridge cover;

[0122] Figure 52 It is a schematic diagram after the device is assembled;

[0123] Figure 53 It is a schematic diagram of the external structure of the device suction nozzle;

[0124] Figure 54 It is a schematic diagram of the internal structure of the device suction nozzle;

[0125] Figure 55 It is a schematic cross-sectional structure diagram of the device suction nozzle;

[0126] Figure 56 It is a schematic diagram of the external structure of the upper cover;

[0127] Figure 57 It is a schematic diagram of the relative position distribution of the medicine storage barrel and the medicine pit;

[0128] Figure 58 It is a schematic diagram of the external appearance of the transitional gear;

[0129] Figure 59 It is a schematic diagram of the external appearance of the lid;

[0130] Figure 60 It is a schematic diagram of the external appearance of the counter from the bottom view;

[0131] Figure 61 It is a schematic diagram of the gear meshing condition of the counting module;

[0132] Figure 62It is a schematic diagram of the shotweight experimental results of the pure lactose formulation of the present invention;

[0133] Figure 63 It is a schematic diagram of the shotweight experimental results of the lactose + API formulation of the present invention.

[0134] In the figure, 1 is the device nozzle; 2 is the device upper cover; 3 is the housing; 4 is the device air inlet; 5 is the knob; 6 is the counting window; 7 is the upper flow channel member; 8 is the middle flow channel member; 9 is the lower flow channel member; 10 is the counter; 11 is the intermediate gear; 12 is the counter cover; 13 is the transmission cylinder; 14 is the compression spring; 15 is the vibration tooth; 16 is the turntable; 17 is the transmission pawl; 18 is the medicine bucket cover; 19 is the lower housing; 20 is the lid;

[0135] 101 is the medicine outlet; 102 is the square groove; 103 is the card slot; 201 is the snap hole; 202 is the upper cover edge;

[0136] 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;

[0137] 501 is the protrusion; 502 is the step; 503 is the gear shaft hole; 504 is the limit block; 505 is the buckle structure;

[0138] 701 is the pin; 702 is the pin; 703 is the pin; 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;

[0139] 801 is the pin hole; 802 is the pin hole; 803 is the pin hole; 804 is the pin hole; 805 is the pin hole; 806 is the pin hole; 807 is the pin hole; 808 is the pin hole;

[0140] 901 is the first medicine storage barrel; 902 is the second medicine storage barrel; 903 is the first flow port; 904 is the second flow port; 906 is the central hole; 907 is the edge of the lower flow channel member;

[0141] 9001 is the pin; 9002 is the pin; 9003 is the pin; 9004 is the pin; 9005 is the pin;

[0142] 1001 is the tooth; 1002 is the top block; 1003 is the positioning hole;

[0143] 1101 is the lower gear; 1102 is the upper gear; 1103 is the positioning hole;

[0144] 1201 is the counter cover protrusion; 1202 is the snap hole; 1203 is the intermediate gear shaft hole; 1204 is the transmission main shaft gear shaft hole; 1205 is the concave groove;

[0145] 1301 is the clamping block; 1302 is the clamping hole; 1303 is the ratchet pawl groove; 1304 is the spring groove; 1305 is the round hole;

[0146] 1501 is the slot hole; 1502 is the tooth shape;

[0147] 1601 is the buckle; 1602 is the buckle; 1603 is the 10mg medicine pit; 1604 is the 5mg medicine pit; 1605 is the turntable vibration tooth; 1606 is the mating hole; 1607 is the cantilever; 1608 is the cantilever; 1691 is the medicine storage space; 1692 is the medicine storage space;

[0148] 1701 is the guide rail; 1702 is the transmission shaft; 1703 is the positioning point; 1704 is the ratchet pawl; 1705 is the transmission gear;

[0149] 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-shaped channel; 2001 is the lid buckle. Detailed implementation mode

[0150] The present invention will be further described below with reference to the drawings and embodiments.

[0151] Under the background of the prior art, the present invention provides a dual-reservoir powder inhaler device containing two medicine storage barrels, which can achieve the following functions:

[0152] 1) Store the two drug prescriptions separately in two medicine storage barrels, and deliver them to the dispersion chamber through separate medicine pits and separate delivery channels, and then deliver them to the outlet through the suction nozzle channel.

[0153] 2) There will be corresponding operation prompts during the operation of the device to tell the user that the operation is in place or correct.

[0154] 3) There is a corresponding counter to tell the patient how much remaining dose is in the device.

[0155] 4) The drugs in the two medicine storage barrels are simultaneously delivered from the medicine storage barrels to the medicine pits for single-dose dispensing and then to the dispersion chamber and then to the outlet, so as to ensure that the drugs of the two doses can be simultaneously dispersed and delivered to the patient's body.

[0156] 5) The sizes of the two medicine pits are adjustable, that is, customizable.

[0157] 6) The drugs in the two medicine storage barrels can be simultaneously and accurately delivered into the medicine pits.

[0158] Compared with a simple single-reservoir system, there are the following several difficulties in the design of a dual-reservoir powder inhaler device containing two medicine storage barrels:

[0159] a. After different drugs are mixed with lactose, the prescription has different flow characteristics, and the fluidity will affect the accuracy of the drug prescription being dispensed from the medicine storage barrel into the medicine pit.

[0160] In the present invention, the prescriptions stored in two different medicine storage barrels may have different fluidities (for one prescription with good fluidity, it can be easily and accurately dispensed into the medicine pit; for the other prescription with poor fluidity, it is more difficult to dispense, and it needs to be knocked a certain amount to be accurately dispensed). Therefore, a vibration system needs to be designed that can simultaneously meet the dispensing requirements of the two different prescriptions.

[0161] b. After the medicine pit is dispensed with a single inhalation drug dose from the medicine storage barrel outlet and moves to the flow port, the movement trajectory should not form an intersection on the basis of having two. For a single-chamber powder inhaler device, based on a single medicine storage barrel and the delivery channel, there is only one trajectory for the medicine pit to move from the medicine storage barrel outlet after being dispensed with a single inhalation drug dose to the flow port (the initial position of the delivery channel), so the design space is relatively large (relatively easy).

[0162] On the basis of the original single-chamber design, the present invention adds an additional medicine storage barrel, and according to the purpose of the present invention, this medicine storage barrel needs to be independent of the original one. Therefore, there are two medicine storage barrel outlets. In addition, according to the purpose of the present invention, the delivery channels for the two drugs must also be independently established, so there are also two flow ports. Therefore, there will be two movement paths from the medicine storage barrel outlet to the flow port in the present invention. Starting from the principles of mechanical design and manufacturing, these two paths cannot form an intersection. Once there is an intersection, interference will occur in the part design (with interference, the structure cannot be designed and processed).

[0163] c. Continuing from difficulty point b, during the process of the two medicine pits moving along their respective independent movement trajectories to the flow port after being dispensed from their respective medicine storage barrels, counting also needs to be completed simultaneously. For a single-chamber powder inhaler device, because there is only one such movement trajectory, the design space for the linkage drive of the counting structure is relatively large and is relatively easy. The double-chamber powder inhaler device designed in the present invention has two such trajectory channels. Therefore, when designing the counting structure, it is necessary to simultaneously index and link the two trajectories. It is necessary to ensure that after the two medicine pits are dispensed from the medicine storage barrels and move to the flow port, counting is completed simultaneously (there should be no sequence).

[0164] d. After the final design, the powder inhaler device should be small enough to be easily held in the patient's hand. Even with the addition of two medicine storage barrels, the volume of the powder inhaler device should not be much larger, or even unchanged, compared to a single reservoir. This poses a great challenge to the overall design and layout of the components because there should be no significant bends in the flow channel design (bends envisioned for space savings). If such significant bends occur, it is easy to cause residues in the dispersion channel when delivering drug particles.

[0165] In view of the above technical status and R & D difficulties, the technical solution of the present invention takes the following measures:

[0166] 1) Design a powder inhaler device with a double reservoir, that is, a device with two medicine storage barrels that can store two different types of drug prescriptions respectively, such as compound preparation + single - ingredient preparation and single - ingredient preparation + single - ingredient preparation, etc. For the combination of the former compound preparation (2 active ingredients) + single - ingredient preparation (1 active ingredient), it can contain 3 active ingredients. For active ingredients with compatibility problems or poor stability, they can be isolated and made into preparations for filling.

[0167] 2) Reduce the difficulty of the preparation technology. For the powder inhaler prescription, mixing a single active ingredient (or two active ingredients) with lactose is less difficult than mixing three active ingredients with lactose simultaneously.

[0168] 3) The designed double - reservoir powder inhaler device can include the functions of a single - reservoir powder inhaler device, that is, it can be used to deliver single - type preparation prescriptions containing a single active ingredient or two active ingredients (the device can be used as a single - reservoir device).

[0169] 4) When designing the parts of the double - reservoir powder inhaler device, based on the principles of convenient installation and modular installation, make it convenient for automatic production on an industrial automatic production line.

[0170] 5) The double - reservoir powder inhaler device designed in the present invention adopts a "rotary disk" - type dose - dividing structure. Compared with existing such products (such as Symbicort Turbuhaler), the device of the present invention can remove the activation operation in the structural design (the addition of the activation operation is theoretically not conducive to patient use).

[0171] Specifically, the complete technical solution of the present invention is as follows:

[0172] The outer shape of the double - reservoir powder inhaler device of the present invention is as Figure 1a shown.

[0173] When the patient operates the double - reservoir powder inhaler device, first rotate Figure 1aThe knob 5 in it is turned approximately 90 degrees (when it is turned to 90 degrees, a clicking sound will be heard inside the device, indicating that the knob has been turned in place), and the effect diagram after the knob 5 is turned 90 degrees is as shown in Figure 1b ; secondly, turn the knob 5 back to the Figure 1a initial state (at this time, a clicking sound will be heard again inside the device to indicate that the knob has been turned back in place), thus completing the action of dispensing the drug in a single inhalation dose from the medicine storage cylinder (when turning the knob, the patient needs to hold the device vertically); at the same time, the counter 10 counts one rotation, and the reading on the surface of the counter 10 can be read by the patient through the Figure 1a counting window 6.

[0174] Figure 2 Figure Figure 3 and Figure 4 show a cross-sectional view of the overall structure of the dual-reservoir powder inhaler device (also known as the general assembly drawing), in which the cooperation between the counter cover 12 and the knob 5 is achieved through the protrusion 501 and the step 502 (the structures of the protrusion 501 and the step 502 are respectively as shown in Figure 4 , and the three straight lines in Figure 4 point to three identical protrusions 501), the step 502 serves as a supporting part for the counter cover 12, and the protrusions 501 around the inner side of the knob 5 play a limiting role on the counter cover 12, enabling the counter cover 12 to rotate in the same direction as the knob 5 by the same angle.

[0175] The effect and installation direction after the counter cover 12 and the knob 5 are assembled are respectively as shown in Figure 5 and Figure 6 . A transition gear 11 and a counter 10 are also correspondingly installed between the counter cover 12 and the knob 5 (as shown in Figure 7 , and the exploded view and arrow direction in 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 fitted through the gear shaft hole 503 at the bottom of the knob 5 (the position and shape of the gear shaft hole 503 are as shown in Figure 3 and Figure 4 ) as a rotation base, and then meshes through the teeth 1001 inside the counter 10 (as shown in Figure 7 ).

[0176] In summary, Figure 7 the knob 5, the counter 10, the transition gear 11, and the counter cover 12 in Figure 7 together form the counting module of the dual-reservoir powder inhaler device as shown in Figure 5 and Figure 6 .

[0177] The counting module is snapped into the card slot 1901 on the side of the lower housing 19 through the snap structure 505 (the position and shape of the snap structure 505 are as shown in Figure 3 ), and the structure of the lower housing 19 is asFigure 8 , Figure 9 as well as Figure 10 As shown, the shape of the card slot 1901 on the lower shell 19 is as follows Figure 9 Assembling is accomplished within the

[0178] In this technical solution, the card slot 1901 has two functions:

[0179] 1) Limit 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 ( Figure 5 and Figure 6 The side view and top view of the counting module are shown respectively. Figure 7 shows an exploded view of the counting module).

[0180] 2) The knob 5 can be rotated about 90 degrees along the slot 1901 relative to the lower housing 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 as shown in FIG. Figure 9 shown).

[0181] After the buckle structure 505 on the knob 5 is inserted into the slot 1901, the assembly effect between the knob 5 and the lower housing 19 is as follows: Figure 11 , Figure 12 , Figure 13 as well as Figure 14 As shown, because the lower shell 19 is a hollow structure (from Figure 8 ), so there is enough space for the counter cover protrusion 1201 on the counter cover 12 to move.

[0182] Figure 12 The direction of the middle arrow is the rotation direction of the knob 5. Since the counter cover 12 will rotate in the same direction as the knob 5, the counter cover 12 will rotate freely relative to the lower housing 19 in the arc channel 1906 of the lower housing 19 (the arc channel 1906 limits the rotation angle of the counter cover protrusion 1201 of the counter cover 12 to 90 degrees). When the lower housing 19 is assembled, the final installation of the counting module is completed. Figure 13 The direction of the arrow in FIG. 1 is the assembly direction of the knob 5 relative to the lower housing 19 .

[0183] The core transmission structure of the double-reservoir powder aerosol device is as follows: Figure 15 and Figure 16 As shown, the transmission structure can achieve: the turntable 16 drives the counter 10 to rotate unidirectionally while rotating 90 degrees back and forth (the turntable 16 rotates in the same direction as the knob 5).

[0184] The core transmission structure is composed of a transmission cylinder 13, a compression spring 14, a vibration tooth 15, a transmission pawl 17 and a cover 20.Figure 16 As shown ( Figure 16 the arrow in is the installation direction of the parts).

[0185] The structures of the transmission cylinder 13 and the transmission pawl 17 are respectively as Figure 17 , Figure 18 , Figure 19 , Figure 20 and Figure 21 shown (the structure of the transmission cylinder 13 is as Figure 17 , Figure 18 and Figure 19 shown, the structure of the transmission pawl 17 is as Figure 20 and Figure 21 shown). During installation, first insert the transmission pawl 17 into the pawl groove 1303 inside the transmission cylinder 13 to complete the installation of the transmission pawl 17, and the effect is as Figure 22 shown; secondly, place the compression spring 14 into the transmission cylinder 13. 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 Figure 19 cross-sectional view), then align the slot hole 1501 of the vibrating tooth 15 with the guide rail 1701 of the transmission pawl 17 and insert it (the structure of the vibrating tooth 15 is as Figure 23 shown), and finally cover the lid 20 to complete the installation of the core transmission structure. The installation cross-sectional view is as Figure 24 shown.

[0186] After the core structure is installed, insert it into the lower housing 19. By engaging the clamping blocks 1301 on both sides of the transmission cylinder 13 with the positioning blocks 1904 in the lower housing 19, the assembly of the counting module and the transmission structure is realized (as Figure 25 and Figure 26 shown).

[0187] In the Figure 26 viewpoint, the situation where the clamping block 1301 of the transmission cylinder 13 is engaged with the positioning block 1904 of the lower housing 19 can be seen. The situation shown in this figure is used to illustrate that the transmission structure composed of the transmission cylinder 13, the compression spring 14, the vibrating tooth 15, the transmission pawl 17, and the lid 20 remains stationary relative to the lower housing 19 and does not rotate during the relative rotation of the knob 5 and the counter lid 12 with respect to the lower housing 19.

[0188] After the above structure is installed, snap the turntable 16 into the snap holes 1202 on the counter lid protrusion 1201 through the snaps 1601 and 1602 on both sides (the two snaps have the same shape) (the structure of the counter lid 12 is as Figure 29 shown). After the snaps 1601 and 1602 on both sides of the turntable 16 are snapped in, the turntable 16 can rotate synchronously with the counter lid 12. When the counter lid 12 rotates about 90 degrees, the turntable 16 rotates the same angle in the same direction.

[0189] In summary, the rotation of the knob 5 drives the rotation of the counter 12. Also, due to the snap fit between the counter 12 and the turntable 16, the counter 12 drives the rotation of the turntable 16. Therefore, the rotations of the turntable 16 and the knob 5 are synchronous and in the same direction.

[0190] The external structure of the turntable 16 is as Figure 27 and Figure 28 shown. The installation effect of the turntable 16 is as Figure 30 and 31 shown.

[0191] From Figure 30 and 31 it can be seen that at this time, the turntable 16 has been tightly snapped together with the counter 12 through the snap. When the turntable 16 starts to rotate in the same direction as the knob 5, the turntable vibration teeth 1605 under the turntable 16 (the external structure of the turntable vibration teeth 1605 is as Figure 28 shown) are in a "smooth tooth" meshing with the tooth profile 1502 on the vibration teeth 15 (the tooth profile 1502 on the vibration teeth 15 has been marked with a straight line in Figure 23 ). And the vibration teeth 15 do not rotate relative to the lower housing 19 at this time. Therefore, relative sliding will occur between the vibration teeth 15 and the turntable vibration teeth 1605 along the axis direction (the kinematic diagram of the relative sliding of the vibration teeth is as Figure 33 shown). Subject to the force in the inclined plane direction of the turntable vibration teeth 1605, the vibration teeth 15 will squeeze the compression spring 14 along the guide rail 1701 on the transmission pawl 17 and move (as Figure 32 shown. In the figure, the vibration teeth 15 have been separated from the turntable 16 and moved a short distance. It can be seen in the figure that the structure of the turntable vibration teeth 1605 is exposed. Relatively, Figure 34 shows the state where the vibration teeth 15 and the turntable 16 are not separated, and the turntable vibration teeth 1605 are hidden therein).

[0192] When it rotates 90 degrees, the turntable vibration teeth 1605 will snap into the next tooth groove of the vibration teeth 15. At this time, under the action of the elastic potential energy released by the compression spring 14 (the installation position of the compression spring 14 is as Figure 31 shown), a sound will be emitted due to the mutual collision between the turntable vibration teeth 1605 and the vibration teeth 15. This is the origin of the sound emitted during the patient's first operation. At the same time as this collision emits a sound, it will also generate a vibration inside the device, thereby assisting 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.

[0193] During the above process, the vibration tooth 15 does not rotate relative to the lower housing 19 because the driving pawl 17 realizes shaft-hole fit with the slot hole 1501 on the vibration tooth 15 through its guide rail 1701 (as Figure 35 shown), and the shapes of the slot hole 1501 and the guide rail 1701 are linear (as Figure 20 and 23 shown), so the vibration tooth 15 can rotate coaxially and synchronously with the driving pawl 17.

[0194] When the knob 5 starts to rotate, the rotation direction of the turntable 16 (because of the cooperation with the counter cover 12, the turntable 16 rotates synchronously and in the same direction as the knob 5) is opposite to the direction of the pawl 1704 relative to the driving pawl 17 (the assembly position of the driving pawl 17 in the driving cylinder 13 is as Figure 22 shown). At this time, the pawl 1704 is pushed by the pawl groove 1303 in the rotation direction. Therefore, the driving pawl 17 will not rotate. Correspondingly, due to the "linear shaft-hole" fit, the vibration tooth 15 will not rotate either (at this time, the vibration tooth 15 will only move a short distance along the guide rail 1701, as shown in Figure 32 and Figure 35 shown respectively, where the arrow mark direction in Figure 35 is the moving direction of the vibration tooth 15).

[0195] When the patient rotates the knob 5 back to the initial position (the initial position is as Figure 1a shown), at this time, the meshing direction between the vibration tooth 15 and the turntable vibration tooth 1605 is "reverse tooth (inverted tooth)", and the relative movement between the two is no longer relative sliding, but coaxial and in the same direction without separation and rotation together (the turntable vibration tooth 1605 under the turntable 16 will push against the tooth profile 1502 of the vibration tooth 15 during rotation). Therefore, when the turntable 16 rotates back to the initial state along with the knob 5, the turntable vibration tooth 1605 structure under the turntable 16 will drive the vibration tooth 15 to rotate together. Since the vibration tooth 15 and the driving pawl 17 achieve shaft-hole fit through a linear slot hole, the vibration tooth 15 will drive the driving pawl 17 to rotate synchronously. During the rotation of the driving pawl 17, because the pawl 1704 is deformed due to the extrusion of the wall surface of the pawl groove 1303, when the knob 5 rotates back to the initial position, the pawl 1704 will return to its original state and snap into the corresponding position of the pawl groove 1303. At this time, since the pawl 1704 is deformed due to the extrusion of the wall surface of the pawl groove 1303 and then returns to the deformed state and snaps into the pawl groove 1303, a sound will be emitted, which is the origin of the sound when the patient operates and rotates the knob 5 for the second time.

[0196] At the same time as the sound is emitted, the entire driving pawl 17 also rotates 90 degrees along the axis. Similarly, the driving gear 1705 below the driving pawl 17 will also rotate 90 degrees unidirectionally along the axis.

[0197] According to the above principle, the sound emitted by the device during the process of the patient turning the knob 5 by 90 degrees is greater than the sound emitted when turning the knob 5 back to the initial position for the second time. Because the first sound is emitted by the vibration teeth 15 hitting the turntable vibration teeth 1605 under the turntable 16 under the extrusion of the compression spring 14, while the second sound is only emitted by the deformation of the pawl 1704. In terms of intensity, the first sound is louder. Similarly, this sound will also generate corresponding vibrations, which assist 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 and the 10mg medicine pit 1603 respectively.

[0198] Based on the fact that the two drug prescriptions loaded in the first medicine storage barrel 901 and the second medicine 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 dosed into their respective medicine pits.

[0199] The above is the basic principle that the transmission structure composed of the transmission cylinder 13, the compression spring 14, the vibration teeth 15, the transmission pawl 17 and the lid 20 converts the reciprocating rotation of the turntable 16 into the one-way rotation of the transmission gear 1705 under the transmission pawl 17. The one-way rotation of the transmission gear 1705 will synchronously drive the rotation of the intermediate gear 11 and the counter 10, so as to realize counting (as Figure 31 can be seen, the meshing situation of the transmission gear 1705, the intermediate gear 11 and the counter 10), and this counting function can realize the indexing of the dose separation for two independent medicine storage barrels at the same time.

[0200] As a reservoir-type powder inhaler device, one of the most important functions is to store drugs. As a double-reservoir powder inhaler device, the following two functions need to be ensured:

[0201] 1) During the process of storing drugs, ensure that the two drug powders are stored in their respective medicine storage barrels and do not come into contact with each other.

[0202] 2) After the patient operates the knob 5, the required single inhalation dose can be separated from the two medicine barrels.

[0203] In the present invention, the turntable 16 and the lower member 9 of the flow channel are in a fitting state after assembly, and the fitting state is as Figure 36 shown.

[0204] Due to the fitting of the two, two medicine storage spaces 1691 and 1692 are respectively formed between the turntable 16 and the first medicine storage barrel 901 and the second medicine storage barrel 902 (circled with a dotted line in Figure 36 ).

[0205] After turning the knob 5 by about 90 degrees, the two medicine pits on the turntable 16 will be respectively rotated to the lower sides of the first medicine storage barrel 901 and the second medicine storage barrel 902 (asFigure 37 As shown, while rotating, the powders in the first medicine storage barrel 901 and the second medicine storage barrel 902 will be respectively fed into the 5mg medicine pit 1604 and the 10mg medicine pit 1603 from the medicine storage spaces 1691 and 1692. At this time, the powders in the two medicine pits still do not come into contact with each other.

[0206] When the rotary knob 5 is rotated to the initial state (the initial state of the knob 5 is as Figure 1a shown), the 5mg medicine pit 1604 and the 10mg medicine pit 1603 will be rotated back to the positions of the two first flow ports 903 and the second flow port 904 of the flow channel lower member 9 (as Figure 38 shown, Figure 38 in the top view, when the knob 5 is rotated to the initial position, the first flow port 903 is aligned with the 10mg medicine pit 1603, and the second flow port 904 is aligned with the 5mg medicine pit 1604), waiting for the patient to inhale.

[0207] In Figure 38 , the movement trajectories of the 5mg medicine pit 1604 and the 10mg medicine pit 1603 during the 90-degree back-and-forth rotation of the above-mentioned knob 5 are also marked (shown by the dotted lines). According to the aforementioned difficult requirements, these two separate movement trajectories of the medicine pits do not interfere with each other as seen from Figure 38 . Therefore, in this embodiment of the invention, the selected path scheme is feasible.

[0208] In the present invention, the flow channel space of the dual-reservoir powder aerosol device (the space where the drug particles fly out when delivered from the powder aerosol device) is composed of the flow channel upper member 7, the flow channel middle member 8, and the flow channel lower member 9. The assembly relationship diagram of the three is as Figure 46 shown.

[0209] The flow channel middle member 8 is fixed by being respectively matched with the pins 9001 - 9005 on the flow channel lower member 9 through the pin holes 801 - 805, while the flow channel upper member 7 is fixed by being matched with the pin holes 806 - 808 of the flow channel middle member 8 through the pins 701 - 703 (the outer shape of the flow channel upper member 7 is as Figure 47 shown).

[0210] The effect after the assembly of the flow channel upper member 7, the flow channel middle member 8, and the flow channel lower member 9 is as Figure 48 shown. The three form a first space channel 7893 and a second space channel 7894 for the drug particles respectively coming from the 10mg medicine pit 1603 and the 5mg medicine pit 1604 to fly. The former is for the drug particles from the 10mg medicine pit 1603 to fly, and the latter is for the drug particles from the 5mg medicine pit 1604 to fly, as Figure 49 shown ( Figure 49 is a half-sectional view).

[0211] To fix the lower runner component 9 and make the lower runner component 9 fit more closely with the turntable 16, the transmission shaft 1702 above the transmission pawl 17 is inserted into the central hole 906 of the lower runner component 9 (the assembly method is as Figure 41 shown, and the appearance of the lower runner component 9 is as Figure 39 and 40 shown), so as to achieve the coaxial fit of the lower runner component 9 with the turntable 16, the vibration tooth 15, the transmission cylinder 13 and the transmission pawl 17 (as Figure 36 shown). This is because the transmission gear 1705 of the transmission pawl 17 is inserted into the circular hole 1305 of the transmission cylinder 13 (as Figure 18 , Figure 20 and Figure 22 shown), so the transmission pawl 17 and the transmission cylinder 13 are coaxial; also because the guide rail 1701 of the transmission pawl 17 is inserted into the slot hole 1501 of the vibration tooth 15 (as Figure 20 , Figure 21 and Figure 23 shown), therefore the transmission pawl 17 and the vibration tooth 15 are also in coaxial fit; and because the transmission shaft 1702 of the transmission pawl 17 is inserted into the mating hole 1606 of the turntable 16, so the transmission pawl 17 and the turntable 16 are also in coaxial fit (as Figure 28 and Figure 30 shown).

[0212] Therefore, when the lower runner component 9 is in coaxial fit with the turntable 16, it also achieves coaxial fit with the vibration tooth 15, the transmission cylinder 13 and the transmission pawl 17 at the same time.

[0213] At the same time, the edge 301 of the housing 3 exerts a downward pressure on the edge 907 of the lower runner component 9, so that the lower runner component 9 can closely adhere to the turntable 16. The housing 3 itself is initially fixed to the lower housing 19 by snapping the buckle 302 into the fixed card slot 1902 at the rear of the lower housing 19 (the appearance of the housing 3 is as Figure 42 and Figure 43 shown). Secondly, finally, through the insertion of the device nozzle 1, the housing 3 and the lower housing 19 are completely fixed (the insertion direction of the device nozzle 1 is as Figure 44 shown), and the completely fixed state is as Figure 45 shown ( Figure 45 is a cross-sectional view, and it can be seen that the edge 301 of the housing 3 presses the lower runner component 9 and the lower housing 19). When the lower runner component 9 is fixed, subsequently, the middle runner component 8 and the upper runner component 7 are also fixed.

[0214] So far, the main part of the double reservoir is installed, and the appearance of the main body is as Figure 50 shown, and this state is the state of the double reservoir powder aerosol device during filling.

[0215] Figure 51 is the installation position and direction of the medicine barrel lid 18 (as indicated by the arrow in the figure). The function of the medicine barrel lid 18 is to protect the medicinal powder stored in the first medicine storage barrel 901 and the second medicine storage barrel 902 from leaking out. After covering the medicine barrel lid 18, finally cover the upper device lid 2 to complete the assembly of the entire double-reservoir powder aerosol device. The final external view of the device is as shown in Figure 52 shown.

[0216] It should be noted that the shape of the guide rail 1701 of the transmission pawl 17 in the technical solution of the present invention is "one-word", and the corresponding slot hole 1501 of the vibrating tooth 15 is also one-word. The purpose of adopting this structural design is that when the transmission pawl 17 rotates, it can drive the vibrating tooth 15 to rotate together. When the transmission pawl 17 does not rotate, the vibrating tooth 15 can move up and down within a certain small range along the guide rail 1701.

[0217] In practical applications, the shapes of the guide rail and the slot hole are not limited to one-word, and can also be cross-shaped, or cross-cross type.

[0218] In this embodiment, the one-word design is adopted because in the actual operation of the first edition mold and 3D printing, the one-word guide rail has the best effect. When the vibrating tooth 15 moves back and forth, the friction force it receives is relatively small and it is not easy to get stuck.

[0219] It should be noted that in the present invention, the rotation angle of the knob 5 is limited to 90 degrees. During the process of the knob 5 rotating back and forth, the components that always rotate in the same direction and synchronously with the knob 5 are: the turntable 16 and the counter cover 12.

[0220] The mating hole 1606 on the turntable 16 is for the insertion of the transmission shaft 1702 on the transmission pawl 17. At the same time, the transmission shaft 1702 on the transmission pawl 17 will also be inserted into the central hole 906 of the flow channel lower member 9, and the central hole 906 of the flow channel lower member 9 is concentric and coaxial with the mating hole 1606 on the turntable 16.

[0221] 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 4 pawls 1704 evenly distributed around the transmission shaft 1702 at 90-degree intervals. The structure of the transmission pawl 17 is as shown in Figure 20 and Figure 21 shown.

[0222] The 10mg medicine pit 1603 and the 5mg medicine pit 1604 on the turntable 16 are respectively aligned with the medicine storage space 1692 and the medicine storage space 1691. In practice, it can be determined which medicine pit is aligned with which medicine storage space according to the actual situation such as the distribution of the filling line. Because the turntable 16 is circular in external shape design, its buckles 1601 and 1602 have no front or back.

[0223] On the turntable 16, the two medicine pits, the 10mg medicine pit 1603 and the 5mg medicine pit 1604, are respectively used to carry the drug prescription with a dose of 10mg and the drug prescription with a dose of 5mg. In practice, the size of the medicine pits can be adjusted according to the situation.

[0224] The turntable vibration teeth 1605 below the turntable 16 are undulating up and down and are evenly distributed at 90 degrees around the mating hole 1606, as Figure 28 shown.

[0225] Similarly, the tooth profile 1502 on the vibration teeth 15 is also evenly distributed at 90 degrees around the slot hole 1501.

[0226] The simplified diagrams of the tooth profiles of the two vibration teeth are as Figure 33 shown, and the arrow direction is the movement direction of the two vibration teeth when the knob 5 rotates.

[0227] When the knob 5 rotates for the first time, the movement between the tooth profile 1502 on the vibration teeth 15 and the turntable vibration teeth 1605 below the turntable 16 is relative sliding - separation - knocking engagement. When the knob 5 rotates back for the second time, the tooth profile 1502 on the vibration teeth 15 meshes with the turntable vibration teeth 1605 below the turntable 16 and rotates coaxially (without separation).

[0228] The included angle between the two medicine pits on the turntable 16, the 10mg medicine pit 1603 and the 5mg medicine pit 1604, is 180 degrees. Correspondingly, the included angle between the first medicine storage barrel 901 and the second medicine storage barrel 902 is also 180 degrees. That is, the included angle between the line connecting the 10mg medicine pit 1603 and the 5mg medicine pit 1604 and the line connecting the first medicine storage barrel 901 and the second medicine storage barrel 902 is 90 degrees (as Figure 57 shown), and this angle is designed based on the rotation angle of the knob 5. When the knob 5 rotates Figure 57 counterclockwise by 90 degrees, the 10mg medicine pit 1603 will be rotated to the lower part of the second medicine storage barrel 902, and correspondingly, the 5mg medicine pit 1604 will be rotated to the first medicine storage barrel 901 to complete the sub - dosing of the corresponding medicine pits.

[0229] Furthermore, Figure 1a and Figure 1b the direction shown is facing the patient, and the rotation direction of the knob 5 is to rotate 90 degrees to the right facing the patient, and this direction is the rotation direction (operation direction) of the knob 5 in this embodiment.

[0230] The function of the lid 20 is to give a preliminary limit to the vibration teeth 15. During the installation of the vibration teeth 15, under the elastic force of the compression spring 14, it will be pushed out of the transmission cylinder 13, so that the slot hole 1501 is separated from the guide rail 1701, and it may not be well positioned during installation. Therefore, the design purpose of the lid 20 is to facilitate the installation of the dual - reservoir powder aerosol device.

[0231] The drive cylinder 13 is fixed by fitting 4 clamping blocks 1301 into the positioning blocks 1904 of the lower housing 19. In practice, if cost is a consideration, the drive cylinder 13 and the lower housing 19 can be made into one component.

[0232] There is a square groove 102 inside the device nozzle 1 for clamping and fixing the leading edge 781 of the flow channel.

[0233] In addition, corresponding clamping grooves 103 are provided on both sides inside the device nozzle 1 for cooperating with the nozzle clamping latches 305 on both sides of the housing 3 to fix the nozzle. When the nozzle is installed, the leading edges 781 of the upper flow channel member 7 and the middle flow channel member 8 will be wrapped.

[0234] The intermediate gear 11 has two layers of gears. The lower gear 1101 meshes with the teeth 1001 inside the counter 10, and the upper gear 1102 meshes with the transmission gear 1705 below the transmission pawl 17.

[0235] The circular hole 1305 in the middle of the drive cylinder 13 allows the transmission gear 1705 to pass through. When the transmission pawl 17 is inserted into the pawl groove 1303, the transmission gear 1705 below the transmission pawl 17 will pass through the circular hole 1305.

[0236] When the drive cylinder 13 is fixed into the lower housing 19, since the transmission gear 1705 below the transmission pawl 17 is exposed outside the drive cylinder 13, it can mesh with the upper gear 1102 of the intermediate gear 11.

[0237] On the counter cover projection 1201 of the counter cover 12, there is a clamping hole 1202 for the clamping latches 1601 and 1602 on both sides of the turntable 16 to be inserted. At the same time, there are two concave grooves 1205 on the counter cover projection 1201 to support and limit the cantilevers 1607 and 1608 on the turntable 16.

[0238] There are two clamping latches 2001 on both sides of the cover 20, which are semicircular in shape (as Figure 59 shown), and are inserted into the clamping holes 1302 of the drive cylinder 13 to fix the cover 20.

[0239] The cover 20 can play a preliminary limiting role for the vibrating teeth 15 under the elastic force of the compression spring 14.

[0240] On the flow channel assembly composed of the upper flow channel member 7, the middle flow channel member 8 and the lower flow channel member 9, there are air inlets 7891 and 7892 (as Figure 48 shown) for the patient's inhalation airflow to enter the flow channel, so as to realize the delivery and entrainment of drug particles.

[0241] The upper cover 2 of the device is fitted with the upper cover buckle 303 on the housing 3 through the buckle holes 201 to achieve a tight fit between the upper cover 2 of the device and the housing 3.

[0242] According to Figure 1b the rotation direction of the knob, the rotation direction of the counter 10 Figure 12 is consistent with the arrow direction (counterclockwise) marked in the figure. A limit block 504 is provided in the knob 5 (as Figure 4 shown), which can limit the rotation of the counter 10. When the counter 10 rotates to the specified number of suction times, it will be blocked by the limit block 504.

[0243] The rotation angle of the counter 10 per suction is set to 5 degrees, and the corresponding rotation angle of the transmission gear 1705 below the transmission pawl 17 is 90 degrees (set based on the rotation angle of the knob 5 operation).

[0244] In actual situations, according to requirements, the number of teeth of the intermediate gear 11 and the gear teeth 1001 inside the counter 10 can be changed to change the rotation angle of the counter 10.

[0245] Since the direction of the gear needs to be considered when the transmission gear 1705 below the transmission pawl 17 is installed and inserted, a positioning point 1703 is provided on the pawl 1704 of the transmission pawl 17. The function of this positioning point is for installation positioning. During installation, it should be ensured that the direction of this positioning point faces the edge 1905 of the suction nozzle.

[0246] For the convenience of gear installation, a positioning hole 1103 is provided on the intermediate gear 11. During installation, first place the counter 10 into the knob 5, then rotate the counter 10 to the initial position, and let the top block 1002 below the counter 10 abut against the limit block 504 in the knob 5 as the reference position. Then align the positioning hole 1103 on the intermediate gear 11 with the counting positioning hole 1003 on the counter 10, and insert the intermediate gear 11 into the gear shaft hole 503 in the knob 5 to complete the installation.

[0247] The first medicine storage barrel 901 and the second medicine storage barrel 902 of the lower runner member 9 are in a two - end - through form. This design is for easy demolding during injection molding production. Only when the lower runner member 9 is fitted and assembled with the turntable 16, will the medicine storage spaces 1691 and 1692 be formed.

[0248] Embodiment:

[0249] A. Gear meshing scheme:

[0250] In this embodiment, the rotation angle of the transmission gear 1705 below the transmission pawl 17 is 90 degrees. This angle is designed based on the rotation limit angle of the knob 5 being 90 degrees, and the single - time (single - suction) rotation angle of the counter 10 is 5 degrees.

[0251] Based on the gear transmission theorem, the rotation angle of a gear is inversely proportional to the number of teeth of the gear. According to the above description, the ratio of the rotation angles between the driving gear 1705 and the teeth 1001 of the counter 10 is 18:1, that is, the gear tooth number ratio is 1:18.

[0252] Since this tooth number ratio is large, if no design of intermediate gears is adopted, the outer diameter size of the counter 10 will be very large, thus affecting the overall size of the powder aerosol device.

[0253] Therefore, the design of an intermediate gear 11 is added in this double reservoir powder aerosol device. The intermediate gear 11 is divided into an upper gear 1102 and a lower gear 1101 (as Figure 58 shown).

[0254] Let the rotational speed (rotation angle) and the number of teeth of the driving gear 1705 be w1 and n1 respectively, the rotational speed (rotation angle) and the number of teeth of the counter 10 be w4 and n4 respectively, the rotational speed and the number of teeth of the upper gear 1102 be w2 and n2 respectively, and the rotational speed and the number of teeth of the lower gear 1101 be w3 and n3 respectively. The following relational expressions can be obtained:

[0255]

[0256] Among them, since the upper gear 1102 and the lower gear 1101 are coaxial and integral, thus n2 = n3.

[0257] The above are the tooth number requirements for the normal operation and counting of the four gears in this embodiment.

[0258] The meshing situation of the four gears in the present invention is as Figure 61 shown.

[0259] In the figure, the pitch circles of the four gears are tangent to each other in pairs. Therefore, there is the following relationship on their pitch circle diameters:

[0260] m4n4 = m1z1 + m2z2 + m3z3

[0261] Among them, m1, m2, m3, and m4 are the module of the driving gear 1705, the upper gear 1102, the lower gear 1101, and the teeth 1001 respectively.

[0262] Based on the gear meshing theorem, the module between two meshing gears must be equal, that is, m1 = m2, m3 = m4. Therefore, the above formula is transformed to obtain:

[0263] m4(z4 - z3) = m1(z1 + z2)

[0264] Based on the above two relational expressions and considering the assembly between parts in this embodiment, therefore, in this embodiment, the specific information of the four gears is as follows in the table:

[0265] Gear name Number of teeth Module Drive gear 1705 7 0.5 Upper gear 1102 21 0.5 Lower gear 1101 7 0.4 Tooth 1001 42 0.4

[0266] B. Shotweight Experiment of Dual-Reservoir Device:

[0267] In this embodiment, two different formulations are respectively filled into the two medicine storage barrels of the dual-reservoir for Shotweight testing.

[0268] The test is as follows: After connecting the powder inhaler device to a specific fine powder collector through a rubber adapter, triggering the inhalable state of the powder inhaler device according to the operation, using a vacuum pump system with adjustable flow rate to extract the drug, and then calculating the drug dose delivered by a single inhalation by weighing the weight difference of the device before and after.

[0269] This experiment is used to investigate whether the powder inhaler device can deliver the required drug dose for a single inhalation according to the established pit size.

[0270] In this embodiment, the sizes of the two pits are 5 mg and 10 mg respectively. Therefore, theoretically, the dose separated and delivered from the medicine storage barrel by this device should be 15 mg.

[0271] In this experiment, two different formulations are used to investigate the delivered dose for 30 inhalations:

[0272] Formulation 1: Two commonly used carriers of lactose on the market, with models Lactohale 100 (manufacturer: DFE Pharma) and Inhalec 70 (manufacturer: Meggle) respectively, are mixed into a drug model formulation (without active ingredient) without adding the active ingredient. The mixer used is a Turbula three-dimensional mixer.

[0273] The shotweight experiment results of its pure lactose formulation are as Figure 62 shown in the figure. It can be seen from the figure that the average delivered dose is 15.23 mg and the RSD is 6.25%.

[0274] Formulation 2: Two commonly used carriers of lactose on the market, with models Lactohale 100 (manufacturer: DFE Pharma) and Inhalec 70 (manufacturer: Meggle) respectively, are mixed into a formulation after adding the active ingredient. The mixer used is a Turbula three-dimensional mixer.

[0275] The shotweight experiment results of its lactose + active ingredient formulation are as Figure 63 shown in the figure. It can be seen from the figure that the average delivered dose is 13.72 mg and the RSD is 9.12.

[0276] According to the experimental results of the shotweight above, the RSD of both formulations within the delivery range of 30 inhalations is less than 10%. Relatively speaking, when the formulation contains the active ingredient, the RSD of the delivered dose of the formulation is higher than that of the formulation without the active ingredient.

[0277] This is because, for dry powder inhalers (traditional dry powder inhalers, excluding new types of dry powder inhalers such as macromolecular biopharmaceuticals and antibiotics), most of the active ingredients need to be micronized to a certain extent, and the micronized active ingredients are prone to generating a certain amount of static electricity during the mixing process with the carrier lactose. After the static electricity is generated, it will increase the dose difference of the formulation during delivery in the device.

[0278] In addition, there are also certain differences in the average delivered doses of the two formulations. For the formulation without the active ingredient, the delivered dose is higher than that of the formulation containing the active ingredient. This is because when the active ingredient is mixed in the formulation, the overall fluidity of the formulation will decrease (both types of lactose used in this experiment are large-particle sieved lactose and have good fluidity performance), and the addition of the active ingredient will also make the overall formulation prone to generating static electricity due to external interference. External interferences such as the friction generated between the particles and the channel wall during delivery, etc. All of the above situations will lead to a decrease in the delivered dose.

[0279] In summary, the key technical points of the technical solution of the present invention are as follows:

[0280] 1) The double-reservoir dry powder inhaler device described in the present invention. As a new type of reservoir dry powder inhaler device, it can store two different formulation prescriptions simultaneously, but at the same time, it can ensure that the two prescriptions do not interfere with each other during the storage and dosing processes.

[0281] In the embodiment of the present invention, the included angle between the connecting lines of the spatial arrangements of the first medicine storage barrel 901 and the second medicine storage barrel 902 is 180 degrees, and correspondingly, the included angle with the connecting lines of the first flow port 903 and the second flow port 904 is 90 degrees (as Figure 38 and Figure 57 shown). This angle is determined based on the operating rotation angle of the knob 5.

[0282] 2) The shape and structural design of the turntable 16.

[0283] Specifically, from the perspective of convenient installation, the turntable 16 is designed with snap fasteners 1601 and 1602 in its design. Its shape is "semicircular" and is used to be snapped into the snap holes 1202 on the protrusion 1201 of the counter cover. After being snapped in, the turntable 16 can rotate coaxially and in the same direction with the counter cover 12.

[0284] 3) The distribution of the medicine pits on the 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 pits on the turntable 16: the 10 mg medicine pit 1603 and the 5 mg medicine pit 1604 respectively correspond to the first fluid outlet 903 and the second fluid outlet 904, that is, the included angle between their connection lines and the connection lines of the first medicine storage barrel 901 and the second medicine storage barrel 902 is 90 degrees. After rotation, the 10 mg medicine pit 1603 and the 5 mg medicine pit 1604 respectively correspond to the second medicine storage barrel 902 and the first medicine storage barrel 901.

[0285] 4) In the present invention, the dose-dividing method of the double-reservoir powder aerosol device is realized by means of the rotation of the turntable. Through the 90-degree reciprocating rotation of the turntable 16, the drug powders in the first medicine storage barrel 901 and the second medicine storage barrel 902 are respectively dosed into the 10 mg medicine pit 1603 and the 5 mg medicine pit 1604, and then the powders in the two medicine pits are respectively transferred to the first fluid outlet 903 and the second fluid outlet 904 for delivery. In the above process, the two prescription powders always remain in a non-contact state (before being delivered).

[0286] 5) The design of the transmission structure composed of the transmission cylinder 13, the transmission ratchet 17, the vibration tooth 15, the compression spring 14 and the lid 20 can convert the reciprocating rotation movement of the turntable 16 into the one-way rotation of the transmission gear 1705 below the transmission ratchet 17.

[0287] In this embodiment, the transmission cylinder 13 and the lower housing 19 are separated, but in actual projects, for the consideration of saving part costs, the transmission cylinder 13 and the lower housing 19 can be made into one component. The structure of the lid 20 adopts a snap-fastener design, and its function is to limit the vibration tooth 15 under the elastic force of the compression spring 14. The vibration tooth 15 in the transmission structure is used to engage with the turntable vibration tooth 1605 below the turntable 16.

[0288] 6) The shape and structure design of the transmission ratchet 17 are the key to realizing the function of the transmission structure. The guide rail 1701 on the transmission ratchet 17 serves as the guide rail for the up-and-down reciprocating movement of the vibration tooth 15. Its shape is "one-word" in this embodiment, but it is not limited to "one-word" in practice. If it is "cross" or "cross-cross", it is also okay. The "one-word" shape is selected because in the hand board mold and 3D printing experiments, the vibration tooth 15 receives the least friction during the reciprocating movement. The ratchet teeth 1704 of the transmission ratchet 17 are evenly distributed around the transmission shaft 1702 at an interval of 90 degrees (as shown in Figure 21 ), and this structure can ensure that the transmission ratchet 17 can only rotate in one direction when it rotates. The 90-degree even distribution interval is based on the rotation angle of the knob 5.

[0289] 7) In the technical solution of the present invention, the transmission gear 1705 below the transmission pawl 17 is used to mesh with the intermediate gear 11 in the counting module. The transmission gear 1705 rotates unidirectionally with the transmission pawl 17, driving the unidirectional rotation of the intermediate gear 11 to achieve the unidirectional rotation of the lower counter 10.

[0290] 8) The operation mode of the device adopted in the present invention is achieved by rotating the knob 5 back and forth by about 90 degrees. During the operation process, the device needs to be held vertically.

[0291] In the technical solution of the present invention, two drug prescriptions are separately stored in two medicine storage cylinders. After being delivered to the dispersion chamber through their respective separate medicine pits and separate delivery channels, they are then delivered to the outlet through the nozzle channel. Two different preparation prescriptions can be stored simultaneously, and at the same time, it can be ensured that the two prescriptions do not interfere with each other during the storage and dosing processes. There will be corresponding operation prompts during the operation of the device 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 its two medicine storage cylinders are simultaneously carried out from the medicine storage cylinder to dosing a single inhalation dose and then delivered to the dispersion chamber and then to the outlet to ensure that the drugs of the two drug prescriptions can be simultaneously dispersed and delivered into the patient's body.

[0292] The present invention can be widely used in the field of the 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 dose-dividing structure, a knob located at the upper part of the device, a core transmission structure located inside the device, a turntable, vibrating teeth, and a counting module; characterized in that: 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; Below the first medicine storage barrel and the second medicine storage barrel, a first medicine pit and a second medicine pit are respectively provided; 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 correspondingly arranged with the first medicine pit, and the other end is connected to the dispersion chamber; The second delivery channel is correspondingly arranged with the second medicine pit, and the other end is connected to the dispersion chamber; Two drug prescriptions are separately stored in two medicine storage barrels. By adopting a "turntable" type dose-dividing structure / dose-dividing method, through separate medicine pits and separate delivery channels, after being delivered to the same dispersion chamber, they are delivered to the outlet through the nozzle channel; The process of the drugs in the two medicine storage barrels being discharged from the medicine storage barrels, dispensing a single inhalation dose, and then being delivered to the dispersion chamber and then to the outlet is carried out simultaneously to ensure that the drugs of the two doses can be dispersed and delivered to the patient's body at the same time; During the process of storing drugs in the dual-reservoir powder aerosol device, it is ensured that the two drug powders are stored in their respective medicine storage barrels and do not come into contact with each other; The operation mode of the adopted device is realized by rotating the knob back and forth by about 90 degrees; When operating the dual-reservoir powder aerosol device, first rotate the knob by about 90 degrees. When it is rotated to 90 degrees, a click sound will be heard inside the device, indicating that the knob has been rotated in place; secondly, then rotate the knob back to the initial state. At this time, a sound will be heard again inside the device to indicate that the knob has been rotated back in place, thus completing the action of dispensing the drug of a single inhalation dose from the medicine storage barrel; at the same time, the counter counts and rotates once, and the reading on the surface of the counter can be read through the counting window; After operating the knob, the single inhalation doses of the two drugs required can be separately separated from the two medicine barrels at one time.

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

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

4. The dual-reservoir powder aerosol device according to claim 3, characterized in that The upper flow channel member, the middle flow channel member, and the lower flow channel member are fixed together 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 flow channel member are in a fitting state after being assembled; On the opposite surface of the turntable and the lower flow channel member, a first medicine pit and a second medicine pit are provided; Two medicine storage spaces are respectively formed between the turntable and the first medicine storage barrel and the second medicine storage barrel; After the knob is rotated approximately 90 degrees, two medicine pits on the turntable will be respectively and simultaneously rotated under the first medicine storage barrel and the second medicine storage barrel. When the two medicine pits reach their positions, the powders in the first medicine storage barrel and the second medicine storage barrel will respectively and simultaneously be dosed into the first medicine pit and the second medicine pit from the first medicine storage space and the second medicine storage space, completing the dose division for the corresponding medicine pits at the same time. At this time, the powders in the two medicine pits still do not come into contact with 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 where the two first flow ports and the second flow port of the flow channel lower member are located, waiting for the patient to inhale.

6. The dual-chamber powder aerosol device according to claim 5, characterized in that A turntable vibration tooth is arranged under the turntable. The turntable vibration tooth is in a shape of undulating up and down and is evenly distributed at 90 degrees around the mating hole; Under the turntable, a vibration tooth is arranged, and the tooth shape on the vibration tooth is evenly distributed at 90 degrees around the slot hole; When the knob is rotated for the first time, the movement between the tooth shape on the vibration tooth and the turntable vibration tooth under the turntable is relative sliding - separation - knocking engagement; When the knob is rotated back for the second time, the tooth shape on the vibration tooth meshes with the turntable vibration tooth under the turntable and rotates coaxially without separation; Based on the fact that the two drug prescriptions loaded in the first medicine storage barrel and the second medicine storage barrel may have different fluidities, a knocking vibration mode with two vibrations is adopted to ensure to the greatest extent that the two prescriptions with different fluidities can be accurately dosed 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 barrel, a compression spring, a vibration tooth, a transmission pawl and a lid. The turntable rotates in the same direction as the knob, realizing the function of driving the counter to rotate unidirectionally while the turntable rotates back and forth at 90 degrees.

8. The dual-reservoir powder aerosol device according to claim 1, characterized in that The counting module of the double - reservoir powder inhaler device is jointly composed of a knob, a counter, an intermediate gear and a counter lid; The counter lid and the knob are fitted through a protrusion and a step. The step plays a role in supporting the counter lid, and the protrusions around the inner side of the knob play a role in limiting the counter lid, enabling the counter lid to rotate in the same direction as the knob by the same angle.

9. The dual-reservoir powder aerosol device according to claim 1, characterized in that The double - reservoir powder inhaler device can store at least two different preparation prescriptions at the same time, but can also ensure that the two prescriptions do not interfere with each other during the storage and dose division processes; The dose division structure / dose division method of the double - reservoir powder inhaler device is realized by the rotation of the turntable; through the 90 - degree back - and - forth rotation of the turntable, the drug powders in the first medicine storage barrel and the second medicine storage barrel are respectively dosed into the first medicine pit and the second pit, and then the powders in the two medicine pits are respectively rotated to the first flow port and the second flow port 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 the use operation process, it is necessary to hold the double - reservoir powder inhaler device vertically to normally realize its function.

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