Dose counters and inhaler

Abstract

Dose counters (5) and an inhaler, the dose counters being suitable for an inhaler. A dose counter (5) comprises: an actuating mechanism (50) configured to be driven to move towards a distal end; and a counting component (51) comprising a first counting unit (510) and a second counting unit (511). When the actuating mechanism (50) moves towards the distal end, the first counting unit (510) is driven by the actuating mechanism (50) to count a first group of numbers. When the first counting unit (510) has counted a preset number of times, the second counting unit (511) is driven to count a second group of numbers. Thus, the first counting unit (510) and the second counting unit (511) cooperate with each other to provide a visual digital indication of the number of times that an inhaler has been used.

Description

Dose counters and inhalers Technical Field

[0001] The present application relates to the technical field of inhalers, and in particular to a dose counter and an inhaler. Background Art

[0002] Inhalers are medical devices that may include pressurized metered dose inhalers and dry powder metered dose inhalers. Inhalers may be breath-actuated, that is, they release medication in response to the user's exhaled breath and deliver it to the patient, thereby achieving the purpose of treatment.

[0003] Generally speaking, an inhaler stores multiple doses of medication, and since the appearance of the inhaler cannot display the medication usage status, the user cannot know how many doses of medication are left in the inhaler after each use of a dose of medication. Therefore, it is uncertain whether the user can obtain a complete dose of medication the next time the user uses it, and the user cannot prepare a spare inhaler in advance, which may cause the user to suffer from adverse consequences such as decreased treatment effect, recurrence of the disease, and gradual worsening of the disease due to insufficient dosage or interruption of medication.

[0004] In view of this, how to accurately count the dosage used and display it to the user after each dose of medicine is a technical problem that needs to be solved urgently. Summary of the Invention

[0005] In view of the shortcomings of the above-mentioned related art, the purpose of the present application is to provide a dose counter and a breath-actuated inhaler to overcome the problem in the above-mentioned related art of how to accurately count and display the used dose to the user after each dose of the drug is used.

[0006] To achieve the above-mentioned objectives and other related objectives, the first aspect disclosed in the present application discloses a dose counter suitable for an inhaler, the dose counter comprising: an actuating mechanism configured to move toward a distal end when driven; a counting assembly comprising a first counting unit and a second counting unit; the first counting unit being driven by the actuating mechanism to count a first set of numbers when the actuating mechanism moves toward the distal end, and driving the second counting unit to count a second set of numbers when the first counting unit counts a preset number of times, the first counting unit and the second counting unit cooperating to visually indicate the number of times the inhaler has been used with numbers.

[0007] The second aspect disclosed in the present application discloses a dose counter suitable for an inhaler, the dose counter comprising: an actuating mechanism configured to move toward a distal end when driven; a counting assembly for counting the number of times the inhaler has been used based on the movement of the actuating mechanism toward the distal end, the counting assembly indicating the number of times the inhaler has been used by presenting a visual number in a display window; and a signal element connected to the counting assembly for being driven by the counting assembly to appear in the display window to prompt a user when the number of uses of the inhaler reaches a preset number of uses.

[0008] The third aspect disclosed in the present application discloses a dose counter suitable for an inhaler, the dose counter comprising: an actuating mechanism configured to move toward a distal end when driven; a counter housing having a display window provided thereon; a counting assembly housed in the counter housing, for counting the number of times the inhaler has been used based on the movement of the actuating mechanism toward the distal end, the counting assembly indicating the number of times the inhaler has been used by presenting a visual number in the display window; wherein a display element is configured on the display window to magnify the number in the display window.

[0009] A fourth aspect disclosed in the present application discloses an inhaler, comprising the dose counter according to any one of the first aspect, the second aspect, and the third aspect of the present application.

[0010] A fifth aspect disclosed in the present application discloses a breath-actuated inhaler, comprising: a main housing having a mouthpiece at a distal end thereof; a tank storing a drug solution and axially arranged within the main housing; a force retention unit attached to the main housing and engaged with the tank to activate the tank in response to a user's inhalation through the mouthpiece; a bracket connected to the force retention unit to position the force retention unit; and a dose counter as described in any one of the first, second, and third aspects of the present application, arranged within the main housing and used to count the number of times the inhaler is used.

[0011] In summary, the dose counter and breath-actuated inhaler disclosed in this application accurately count the number of uses by providing a counter assembly with a first and second counter unit that cooperate with each other, and utilizing these first and second counter units to visually indicate the number of times the inhaler has been used. Furthermore, a signaling element is provided to alert the user to the remaining dose in the inhaler.

[0012] Those skilled in the art can easily discern other aspects and advantages of the present application from the detailed description below. In the detailed description below, only exemplary embodiments of the present application are shown and described. As will be appreciated by those skilled in the art, the content of this application enables those skilled in the art to modify the disclosed specific embodiments without departing from the spirit and scope of the invention to which this application relates. Accordingly, the descriptions in the drawings and specification of this application are merely exemplary and not restrictive. BRIEF DESCRIPTION OF THE DRAWINGS

[0013] The specific features of the inventions of this application are set forth in the appended claims. The features and advantages of the inventions of this application can be better understood by referring to the exemplary embodiments described in detail below and the accompanying drawings. A brief description of the drawings is as follows:

[0014] FIG1 is a schematic diagram showing the external structure of a breath-actuated inhaler according to one embodiment of the present application.

[0015] FIG. 2 is a schematic diagram showing the internal structure of a breath-actuated inhaler according to an embodiment of the present application.

[0016] FIG3 is a schematic structural diagram of the main housing in one embodiment of the present application at a certain viewing angle.

[0017] FIG4 is a schematic structural diagram of the main housing in one embodiment of the present application at a certain viewing angle.

[0018] FIG5 is a schematic structural diagram of a force retention unit in one embodiment of the present application.

[0019] FIG6 is a schematic structural diagram of a diaphragm in one embodiment of the present application.

[0020] FIG. 7 is a schematic structural diagram of a bracket in one embodiment of the present application.

[0021] Figure 8 shows a schematic diagram of the inhaler in one embodiment of the present application in a dormant state.

[0022] FIG. 9 is a schematic diagram showing the force retention unit in a dormant state shown in FIG. 8 .

[0023] FIG. 10 is a schematic diagram showing an inhaler in a ready state according to an embodiment of the present application.

[0024] FIG. 11 is a schematic diagram showing the force maintaining unit of the inhaler in an activated state.

[0025] 12 and 13 are schematic structural diagrams of dose counters in different embodiments of the present application.

[0026] FIG. 14 is a schematic diagram showing the state in which the actuating mechanism in the embodiment shown in FIG. 12 of the present application moves toward the distal end.

[0027] FIG15 is a schematic structural diagram of a propulsion unit in one embodiment of the present application.

[0028] FIG. 16 is a schematic diagram showing the split structure of the first counting unit and the second counting unit in one embodiment of the present application.

[0029] 17 and 18 are schematic structural diagrams of the first counting unit in different embodiments, respectively.

[0030] FIG19 is a schematic structural diagram of a propulsion unit in one embodiment of the present application.

[0031] FIG. 20 is a diagram showing the functional state of the stop structure in the propulsion unit shown in FIG. 19 according to the present application.

[0032] FIG. 21 is a schematic diagram showing a situation in which the numbers displayed by the counting component are offset from the display window in one embodiment of the present application.

[0033] FIG. 22 is a schematic diagram showing the state in which the actuating mechanism in the embodiment shown in FIG. 12 of the present application moves toward the proximal end.

[0034] FIG. 23 is a schematic diagram showing that the numbers displayed by the counting component in one embodiment of the present application are correctly displayed in the display window.

[0035] FIG. 24 is a schematic structural diagram of a counting component in one embodiment of the present application at a certain viewing angle.

[0036] FIG25 and FIG26 are schematic diagrams showing the structures of signal elements in different embodiments of the present application.

[0037] FIG. 27 is a schematic diagram showing the engagement of a signal element and a second counting wheel in one embodiment of the present application.

[0038] FIG. 28 is a schematic structural diagram of a counting component in an embodiment of the present application including the signal element shown in FIG. 25 .

[0039] FIG. 29 is a schematic diagram showing the relative positional relationship between the signal element and the actuating mechanism in the embodiment shown in FIG. 25 of the present application.

[0040] 30 to 33 are schematic perspective views of the upper shell of the inhaler in different embodiments of the present application.

[0041] 34 to 37 are schematic diagrams of the embodiments shown in FIG. 30 to 33 from another perspective.

[0042] FIG38 is a partial schematic diagram showing the proximal end of the upper shell in one embodiment of the present application.

[0043] FIG39 is a schematic diagram showing the proximal end of the upper shell in one embodiment of the present application.

[0044] FIG40 is a schematic diagram showing the test case of the present application.

[0045] FIG41 is a schematic structural diagram of the air inlet structure in the comparative example of the present application.

[0046] FIG42 is a schematic diagram showing the test of the comparative example in the present application.

[0047] FIG43 is a line graph showing the gas flow resistance test in the test example and the comparative example of the present application.

[0048] FIG44 is a line graph showing the gas flow resistance test in the test example and the comparative example of the present application. DETAILED DESCRIPTION

[0049] The following is a description of the implementation of the present application through specific embodiments. People familiar with this technology can easily understand the advantages of the present application and the technical effects that can be achieved from the contents disclosed in this specification.

[0050] In the following description, some embodiments may be referred to the accompanying drawings. It should be understood that other embodiments without accompanying drawings may also be used, and that specific structures, parts or mechanisms, components, and operational changes may be made without departing from the spirit and scope of the present application. The following detailed description should not be considered restrictive, and the scope of the embodiments of the present application is limited only by the claims published in this application. The terms used herein are only for the purpose of describing specific embodiments and are not intended to limit the present application.

[0051] Although in some instances the terms first, second, etc. are used to describe various elements or parameters in this article, these elements or parameters should not be limited by these terms. These terms are only used to distinguish one element or parameter from another element or parameter. For example, the first counting unit can be referred to as the second counting unit, and similarly, the second counting unit can be referred to as the first counting unit without departing from the scope of the various described embodiments. The first counting unit and the second counting unit are both describing a counting unit, but unless the context clearly indicates otherwise, they are not the same counting unit.

[0052] Furthermore, as used in this article, the singular forms "one", "an" and "the" are intended to also include plural forms, unless there is an indication to the contrary in the context. It should be further understood that the terms "comprising" and "including" indicate the presence of described features, steps, operations, elements, components, projects, kinds, and / or groups, but do not exclude the existence, occurrence or addition of one or more other features, steps, operations, elements, components, projects, kinds, and / or groups. For example, a process, method, system, product or device comprising a series of steps or units need not be limited to those steps or units clearly listed, but may include other steps or units that are not clearly listed or that are inherent to these processes, methods, products or devices. In addition, the term "and / or" that may be used hereinafter describes the association relationship of associated objects, indicating that three relationships may exist, for example, A and / or B can represent: A exists alone, A and B exist simultaneously, and B exists alone. In addition, the character " / ", if not otherwise specified, generally represents that the associated objects before and after are a kind of "and / or" relationship. In addition, in the description of the embodiments of the present application, "a plurality" refers to two or more than two. Furthermore, the terms "or" and "and / or" used in this document are interpreted as inclusive, or mean any one or any combination. Exceptions to this definition will only occur when a combination of elements, functions, steps or operations are inherently mutually exclusive in some way.

[0053] It should also be understood that when an element such as a layer, region, or substrate is referred to as being "on" another element or extending "onto" another element, the element may be directly on the other element or directly extend onto the other element, or there may be intermediate elements. Conversely, when an element is referred to as being "directly on" another element or "directly extending onto" another element, there are no intermediate elements. It will also be understood that when an element is referred to as being "connected" or "coupled" to another element, it may be directly connected or coupled to the other element, or there may be intermediate elements. Conversely, when an element is referred to as being "directly connected" or "directly coupled" to another element, there are no intermediate elements. Furthermore, the term "coupled" generally means a physical, mechanical, magnetic, and / or electrical coupling or connection, and in the absence of specific language to the contrary, does not exclude the presence of intermediate elements between coupled or associated items.

[0054] Relative terms such as "below" or "above" or "upper" or "lower" or "horizontal" or "vertical" may be used herein to describe the relationship of one element, layer or region to another element, layer or region as illustrated in the figures. It will be understood that these terms are intended to cover different device orientations other than the orientation depicted in the figures. In this application, the "vertical", "horizontal" and "parallel" are defined as including situations within ±10% of the standard definition. For example, vertical usually refers to an angle of 90° relative to a reference line, but in this application, vertical refers to situations within 80° to 100°. Unless otherwise expressly stated, comparative quantitative terms (such as "above" and "below") are intended to cover the concept of equality. As an example, "above" can mean not only "greater than" in a mathematical sense, but also "equal to".

[0055] Unless otherwise defined, all terms (including technical and scientific terms) used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this application belongs. It will also be understood that the terms used herein should be interpreted as having a meaning consistent with their meaning in the context of this specification and the relevant art, and should not be interpreted in an idealized or overly formal sense unless explicitly defined as such in this document.

[0056] In some embodiments provided in the present application, a dose counter and an inhaler using the same are disclosed. The dose counter counts a first set of numbers through a first counting unit, and when counting a preset number of times, it can drive a second counting unit to count a second set of numbers, so that the two sets of numbers of the two counting units can be combined to visually indicate the number of times the inhaler has been used.

[0057] In some embodiments of the present application, the number of times the inhaler is used may refer to the remaining number of times the inhaler is used, or may refer to the number of times the inhaler has been used. For the convenience of distinguishing the above two examples represented by the number of times the inhaler is used in subsequent embodiments, in examples where the number of times the inhaler is used refers to the remaining number of times the inhaler is used, the number of times the inhaler is used is referred to as the remaining number of times or the number of times the inhaler has not been used, and in examples where the number of times the inhaler is used refers to the number of times the inhaler has been used, the number of times the inhaler is used is referred to as the number of times the inhaler has been used. Wherein, the amount of solution distributed for one use of the inhaler corresponds to a dose. In other words, counting the number of times the inhaler is used is equivalent to counting the dose of the inhaler.

[0058] In some embodiments of the application, the use number of times of the inhaler indicated can comprise at least a use number of times of the production stage test and the use number after leaving the factory.For example, the use number of times of the inhaler indicated can comprise the use number of times of the production stage test, that is, two counting units cooperate and can be with the use number of times of the production stage test, so convenient user monitors the test process.For another example, the use number of times of the inhaler indicated can comprise the use number of times of the production stage test, that is, two counting units cooperate and can be with the use number of times of the production stage test, the use number after leaving the factory generally corresponds to actual use, so, make it convenient for the user to instantly understand the use situation of the inhaler, can make the user in time carry out the inhaler reserve on the one hand, avoid also being used by mistake after inhaler has been exhausted on the other hand, delay user's illness.For another example, the use number of times of the inhaler indicated can comprise the use number of times of the production stage test and the use number after leaving the factory, so, can make it convenient for the user monitors the test process, can make it convenient for the user to instantly understand the use situation of the inhaler again.

[0059] In this application, in order to facilitate the description of the positional relationship, the end facing the inhaler's mouthpiece is defined as the distal end (indicated as the distal end in the direction of Z2 in Figure 1), and the end away from the inhaler's mouthpiece is defined as the proximal end (indicated as the proximal end in the direction of Z1 in Figure 1).

[0060] The user described in this application refers to the user of the inhaler, and may be, for example, a tester, a patient, or a subject, etc. Depending on the specific identity of the user, in some embodiments, the user may also be referred to as a tester, a patient, or a subject, etc.

[0061] Initial state described in some embodiments in the application is meant the state when inhaler leaves the factory; Described dormant state is meant the state when inhaler is shelved or deposited, the state presented in for example Fig. 2, at this moment, the dust cover 6 of inhaler is in closed state, and the power in the inhaler keeps unit 4 to be maintained at the extreme position of reachable proximal end, therefore, in some embodiments, also inhaler is referred to as proximal state under dormant state where structure or unit residing state.Ready state described in certain embodiments is meant that inhaler is triggered by dormant state and enters the state of waiting to be started to dispense medicine, for example among Fig. 1, the state when dust cover is opened.Starting state described in certain embodiments is meant the state presented in response to user's inhalation dispense medicine.Described resetting is meant that after inhaler distribution finishes, returns to the process of dormant state, for example the dust cover that opens among Fig. 1 is rotated to the process of closed state among Fig. 2.

[0062] In some embodiments of the present application, a breath-actuated inhaler is proposed, which is configured to initiate drug dispensing in response to a user's inhalation, and the dispensed drug enters the user's respiratory tract and lungs along with the user's inspiratory airflow in the form of soft mist or particles, thereby achieving the purpose of treatment.

[0063] Please refer to Figures 1 and 2. Figure 1 shows a schematic diagram of the external structure of a breath-actuated inhaler in one embodiment of the present application, and Figure 2 shows a schematic diagram of the internal structure of a breath-actuated inhaler in one embodiment of the present application. As shown in the figure, the breath-actuated inhaler includes a main shell 1, a tank 2, a force holding unit 4, a bracket 3, and a dose counter 5.

[0064] Referring to FIG. 3 in conjunction with FIG. 1 , FIG. 3 is a schematic structural diagram of the main housing of one embodiment of the present application from one viewing angle. The distal end of the main housing 1 has a mouthpiece 10. The mouthpiece 10 provides an interface for the user to inhale and has a chamber 100. The dispensing port on the canister 2 or a dispensing port connected to the canister 2 extends into the chamber 100, so that the medicine dispensed through the dispensing port enters the user's mouth through the chamber 100.

[0065] Please refer to Figure 4, which is a schematic structural diagram of the main housing in one embodiment of the present application from a certain perspective. In combination with Figure 2, the main housing 1 has a counting space 11 for arranging the dose counter 5. The counting space 11 can be formed by an inward depression of the main housing 1. In one example, the counting space 11 is provided at the distal end of the main housing 1 and is located on the opposite side of the mouthpiece 10 (it can also be understood that the counting space 11 is provided opposite the mouthpiece 10). Furthermore, a hole structure 110 is provided on the counting space 11. The hole structure 110 can be opened on the side wall of the counting space 11 facing the proximal end. The hole structure 110 allows at least part of the structure of the bracket 3 to pass through to drive the dose counter 5. Taking Figures 2 and 4 as an example, the bracket 3 has a drive rod 30, which can extend through the hole structure 110 to drive the dose counter 5 to count. The structure of the bracket 3 and the dose counter 5 will be described in detail later and will not be repeated here.

[0066] In one embodiment, as shown in Figures 2 and 3, the main housing 1 further has an installation space 12 for arranging the tank 2. The installation space 12 is a groove, recess or similar structure pre-formed on the main housing 1 to accommodate the tank 2.

[0067] In one embodiment, as shown in Figures 1 and 2, a dust cover 6 is further connected to the main housing 1, and the dust cover 6 is rotatably connected to the main housing 1. In one example, as shown in Figure 3, a connecting pin 12 is provided at the distal end of the main housing 1, and the dust cover 6 has a groove (not shown) that matches the connecting pin 12. The connecting pin 12 engages with the groove, so that the dust cover 6 is rotatably disposed at the distal end of the main housing 1.

[0068] In one embodiment, the dust cover 6 has a raised portion, and when the dust cover 6 moves from an open state to a closed state, the raised portion cooperates with the bracket 3 to push the bracket 3 toward the proximal end and lock the dust cover 6 in the closed state. The specific process will be described in detail later and will not be repeated here.

[0069] The tank 2 is used to store multiple doses of drug solution and can also be used to quantitatively dispense drug solution. The tank 2 is axially disposed within the main housing 1. Specifically, the bottom of the tank 2 is positioned proximally within the installation space 12 of the main housing 1. Alternatively, the tank 2 can be described as being inserted upside down within the installation space 12 of the main housing 1. The drug solution includes active pharmaceutical ingredients and pharmaceutical compositions for therapeutic purposes. The active pharmaceutical ingredients are related to the conditions treated by the breath-actuated inhaler. The active pharmaceutical ingredients include, but are not limited to, anti-inflammatory drugs, β2-adrenergic receptor agonists, anticholinergics, antihistamines, serotonin agonists, and combinations thereof. The pharmaceutical composition includes at least one of a propellant (also known as a propellant), a cosolvent, and a surfactant. The propellant is used to spray the drug within the tank in a mist-like form. Examples of propellants include tetrafluoroethane (HFA134a) and heptafluoropropane (HFA227). Examples of cosolvents include ethanol and glycerol. An example of a surfactant is oleic acid.

[0070] In one embodiment, as shown in Figure 2, the tank 2 includes a tank body 20, a valve 21, and a valve stem 22. The tank body 20 has a storage space inside for accommodating multiple doses of pharmaceutical solution. The valve 21 (also referred to as a quantitative valve) is connected to the tank body 20 interior for controlling the size of the dosage. The valve 21 includes a quantitative chamber, which has a communication port connected to the tank body 20 interior. The quantitative chamber can be filled with a dose of pharmaceutical solution or can empty a dose of pharmaceutical solution. In one embodiment, the size of the dosage can be controlled by controlling the volume of the quantitative chamber.

[0071] The valve stem 22 is a hollow stem. The distal end of the valve stem 22 has a dispensing port for allowing the drug solution to be discharged, and the proximal end of the outer diameter surface of the valve stem 22 has an inlet for allowing the drug solution to enter. Specifically, the valve stem 22 is mounted on the valve 21 via a spring. Due to an external force, the valve stem 22 moves relative to the tank body 20 and compresses the spring. When the valve stem 22 moves a predetermined distance, the inlet of the valve stem 22 enters the metering chamber of the valve 21. At this point, a dose of drug solution begins to enter the valve stem through the inlet of the valve stem 22 and is discharged from the dispensing port of the valve stem 22. Furthermore, when the valve stem 22 continues to move and reaches a stop within the valve 21, the valve stem 22 stops moving. In one example, a stopper is provided inside the valve 21 (the stopper can be configured as a sealing ring at the entrance of the quantitative chamber, for example), and the stopper also has a communication port communicating with the interior of the tank body 20. When the valve stem 22 continues to move to the stopper inside the valve 21, the communication path between the quantitative chamber and the tank body 20 is also closed, that is, the communication port is closed. For example, the proximal end of the valve stem 22 also has a sealing surface, and the sealing surface can close the communication port when the valve stem 22 moves a preset distance. When the external force disappears, the valve stem 22 moves under the action of a spring to open the communication port. At this time, the drug solution enters the quantitative chamber from the communication port and the entrance of the valve stem 22 leaves the quantitative chamber of the valve 21.

[0072] As shown in Figure 2, the force holding unit 4 is attached to the main shell 1 and engaged with the tank 2 to activate the tank 2 in response to the user's inhalation through the mouthpiece 10. The force holding unit 4 can be detachably connected to the main shell 1. For example, the force holding unit 4 is connected to the main shell 1 by a snap-fit ​​structure. The force holding unit 4 is used to apply a force toward the distal end to the tank body 20 when the user inhales to activate the tank 2. Specifically, the tank body 20 and the valve 21 move toward the distal end after being subjected to the force, and then the valve stem 22 moves relative to the tank body 20 and the valve 21 and enters the quantitative chamber of the valve 21 so that the drug solution in the quantitative chamber is sprayed out from the valve stem 22 in the form of mist, until the valve stem 22 continues to move to the stop portion inside the valve 21, and the valve stem 22 stops moving.

[0073] In one embodiment, referring to Figures 2 and 5, Figure 5 shows a schematic structural diagram of a force retention unit in one embodiment of the present application. The force retention unit 4 includes an upper housing 40. The proximal end of the upper housing 40 is provided with an air inlet structure 48. The air inlet structure 48 and the mouthpiece 10 can form a gas flow path so that the force retention unit 4 activates the canister in response to the user's inhalation. Specifically, the force retention unit 4 is attached to the main housing 1 via the upper housing 40 and is located at the proximal end of the main housing 1. For example, the upper housing 40 receives the portion of the canister 2 protruding from the main housing 1 and is connected to the main housing 1 via a threaded connector or a snap-fit ​​member. The upper housing 40 and the main housing 1 together constitute the outer shell of the inhaler. To facilitate user operation, in some examples, as shown in Figure 1, when the upper shell 40 is attached to the main shell 1, the central axis of the suction port 10 on the main shell 1 and the central axis of the upper shell 40 form a preset angle α, and the preset angle α is configured to be greater than 90 degrees. In this way, when the user inhales through the suction port 10, the corresponding part of the upper shell 40 will not cause squeezing on other parts of the user's face, which can improve the user experience.

[0074] In actual operation, the user will hold the inhaler to inhale, and the user's incorrect operation (also referred to as misoperation) may cause the user's hand to be at least partially placed on the proximal end of the upper shell. In this way, the user's hand can easily cover the air inlet structure, causing the inhaler to malfunction. In some related arts, there is a schematic diagram of the air inlet structure shown in the comparative example provided in the subsequent Figure 40. The air inlet structure is arranged to be an array of elongated holes formed on the shell, with the long sides of adjacent holes facing each other. Although the structural design of the air inlet hole can form a void space between the cover and the hole so that air can enter through the void space, this method of relying solely on the gap to provide air entry makes the air flow power insufficient, affecting the use of the inhaler, and even causing the inhaler to be insufficient to dispense a sufficient amount of drug solution each time, affecting the therapeutic effect without the user's knowledge.

[0075] In view of this, the inhaler disclosed in some embodiments provided herein comprises an air inlet structure comprising at least two holes located at the proximal end of the upper housing of the inhaler, with the at least two holes arranged in an annular pattern, connected end to end. This annular arrangement prevents a user from completely covering the openings when placing a cover on the proximal end surface during inhalation, thereby facilitating vertical airflow and providing sufficient airflow to ensure the proper function of the inhaler. It should be noted that the cover described above and subsequently refers to the portion of the surface of the inhaler where the user contacts the air inlet structure.

[0076] For example, the covering may be the user's finger, or more specifically, the user's index finger or thumb. For example, the pad of the user's index finger or thumb may be mistakenly placed on the proximal end surface of the inhaler upper shell and cover a portion of the end surface. In this case, in order to prevent the pad of the user's index finger or thumb from blocking the air inlet hole, the present application designs the arrangement of the proximal upper holes of the inhaler upper shell to be arranged in a ring shape, so that even if the user places his thumb or index finger on the proximal end surface due to incorrect operating habits during inhalation, the opening thereon cannot be completely covered, that is, the main opening with the hole is free to enter the air, which can ensure that there is enough space for airflow to enter, ensure the amount of airflow required to trigger the inhaler, and thus ensure the normal operation of the inhaler.

[0077] Refer to Figure 30 to Figure 33, be shown as the three-dimensional structural schematic diagram of the upper shell of the application's inhaler in different embodiments respectively, air enters structure 48 and is configured at the near-end of upper shell 40, can for example be (as shown in Figure 30, air enters structure 48 and is configured at the top end face of upper shell 40) on the end face that is specifically configured at the near-end of upper shell 40 as shown in Figure 30 to Figure 32, also can for example be the zone near the end face of near-end on the sidewall of upper shell 40 as shown in Figure 33.Air enters structure 48 comprises at least two holes 480 with main opening, at least two holes 480 are annularly arranged in the end-to-end mode at the near-end of described upper shell 40, and the annular arrangement can't cover the main openings of whole holes fully when covering is placed on the end face of described near-end during the user's suction period.Like this, can guarantee that the user covers on the near-end end face of inhaler during suction, the main opening that has hole is free to enter air, also promptly can guarantee that there are enough spaces for air-flow to enter, guarantee to trigger the required airflow volume of inhaler. It should be understood that the annular arrangement means that all the holes are connected front to back to form an annular shape, and does not limit the specific shape of the annular shape.

[0078] Wherein, the main opening in hole is the opening of the main body shape that constitutes hole, and taking Figure 30 to Figure 32 as example, the main opening of hole 480 is the opening towards upper zone, and this main opening makes the air-flow (also namely on the inhaler axis direction, as indicated by dotted arrow in Figure 30) that is roughly in vertical direction enter.Taking Figure 33 as example, the main opening in hole 480 is the opening towards the periphery zone, and this main opening makes the air-flow (also namely substantially perpendicular to the inhaler axis direction, as indicated by dotted arrow in Figure 33) that is roughly in lateral direction enter.

[0079] In the embodiment shown in Figures 30 to 33, the cross-section of the proximal end of the upper shell 40 is smaller than the cross-section of its distal end. Furthermore, the cross-section of the upper shell 40 gradually decreases from the distal end to the proximal end, so that the side wall of the upper shell 40 is in the shape of a cone as shown in Figures 30 to 33. However, it should be understood that the appearance shown in Figures 30 to 33 is only an example, and the cross-section of the proximal end and the cross-section of the distal end of the upper shell 40 are not necessarily set to be the same or different. Those skilled in the art can set the upper shell with any external structure according to actual needs.

[0080] Among them, at least two holes are arranged in a ring-like manner in an end-to-end manner, which can be understood as follows: the tail of the first hole faces the head of the second hole, the tail of the second hole faces the head of the third hole, and so on, until the tail of the last hole faces the head of the first hole, and the holes are arranged in a ring as a whole. In the example where only two holes are set, that is, the tail of the first hole faces the head of the second hole, and the tail of the second hole faces the head of the first hole, and the two holes are arranged in a ring. It should be noted that the facing relationship between the tail and the head refers to a relative relationship, or an adjacent relationship, and does not require absolute alignment of the tail and the head.

[0081] In some embodiments, an annular area may be preset at the proximal end of the upper shell 40, and at least two holes may be set at intervals in the annular area so that the holes are arranged in an annular shape. The preset annular area refers to an annular shape that is expected to be formed on the proximal end during manufacturing, and it is not necessary to mark the annular area on the end face of the proximal end of the upper shell 40 in advance. In other embodiments, multiple arc-shaped areas may be preset at the proximal end of the upper shell 40, and the multiple arc-shaped areas are annular as a whole. Holes or one hole may be set at intervals in each arc-shaped area so that all the holes are arranged in an annular shape. The preset multiple arc-shaped areas may correspond to multiple components of the annular shape that is expected to be formed during manufacturing. For example, as shown in Figure 33, two arc-shaped areas 482 are preset at the proximal end of the upper shell 40, and the holes 480 are arranged in accordance with the arc-shaped areas 482.

[0082] Please refer to Figures 34 to 37, which are schematic diagrams of the embodiments shown in Figures 30 to 33 from another perspective. As shown in Figures 34 to 37, two adjacent holes are connected end to end (adjacent) through a connecting portion 481. It should be understood that in this embodiment, the annular arrangement of the at least two holes can be understood as the holes and the connecting portion for connecting the adjacent holes end to end being arranged in an annular shape as a whole. In some examples, the connecting portion 481 can be flush with the main opening of the hole 480, that is, the two adjacent holes 480 and the connecting portion 481 between them are in the same plane. In some examples, the connecting portion 481 may also be protruding or recessed relative to the hole 480, so that the hole 481 can continue to extend from the main opening to both sides to the connecting portion 481 to form a lateral opening, as shown in Figure 38, which is a partial schematic diagram of the proximal end of the upper shell in one embodiment of the present application. Figure 38 takes the recessed proximal end surface of the upper shell 40 of the connecting portion 481 as an example. The recessed connecting portion 481 makes the hole 480 also have a lateral opening toward the vertical plane, thereby allowing airflow in the horizontal direction (that is, the end face or lateral direction, as indicated by the arrow h in Figure 38) to enter.

[0083] In one embodiment, the depth of the depression or the height of the protrusion of the connecting portion 481 is configured to be any value between approximately 0.2 mm and 2 mm, for example, it can be approximately 0.2 mm, 0.3 mm, 0.4 mm, 0.5 mm, 0.6 mm, 0.7 mm, 0.8 mm, 0.9 mm, 1.0 mm, 1.1 mm, 1.2 mm, 1.3 mm, 1.4 mm, 1.5 mm, 1.6 mm, 1.7 mm, 1.8 mm, 1.9 mm, 2.0 mm, etc.

[0084] In one embodiment, the area of ​​the connecting portion 481 is smaller than the area of ​​the main opening of the hole 480, so that the area ratio occupied by the hole in the air inlet structure can be increased, the area available for air intake is increased, and airflow is facilitated. For example, the area of ​​the connecting portion 481 can be configured to be approximately 2mm 2 Up to 10mm 2 For example, it can be configured to be approximately 2 mm 2 , 3mm 2 , 4mm 2 , 5mm 2 , 6mm 2 , 7mm 2 , 8mm 2 , 8.5mm 2 , 9mm 2 , 9.5mm 2 , 10mm 2 , preferably, can be configured to be approximately 8.5mm 2 .

[0085] In one embodiment, the hole is configured as an elongated structure, that is, the hole has a long side and a short side, and the long side and the short side are used to indicate the relative length of the lines in the elongated structure of the hole. It is not required that the long side and the short side must be straight lines or curves. Those skilled in the art can change the shape of the hole according to the teachings of this application and the annular arrangement. Taking the embodiments shown in Figures 34 to 37 as an example, the hole 480 is configured as an elongated hole, and the long side of the hole 480 is approximately a straight line. In other examples, please refer to Figure 39, which is a schematic end face diagram of the proximal end of the upper shell in one embodiment of the present application. As shown in Figure 39, the hole 480 can be configured as an arc-shaped hole. For example, the arc-shaped hole can be further an arc-shaped hole, that is, the overall contour of the hole 480 is a smooth arc. The arc-shaped hole can also be further a non-circular arc-shaped hole, that is, the overall contour of the hole 480 will have a turn or turn (or it can also be understood that the radius of curvature changes), as shown in Figure 39, the hole 480 is configured as a non-circular arc-shaped hole, and the turning point of the contour of the arc-shaped hole forms a corner 4800, and further, the corner 4800 is the middle area toward the proximal end.

[0086] In some embodiments, the width of the hole is configured to be any value between 1 mm and 2 mm, that is, the distance between the two opposite long sides of the hole 480 can be configured to be any value between 1 mm and 2 mm, for example, it can be configured to be approximately 1 mm, 1.1 mm, 1.2 mm, 1.3 mm, 1.4 mm, 1.5 mm, 1.6 mm, 1.7 mm, 1.8 mm, 1.9 mm, 2 mm, etc., preferably, it can be configured to be 1.49 mm. In some examples, the length of the hole is configured to be any value between 2 mm and 32 mm, for example, it can be configured to be approximately 2 mm, 4 mm, 6 mm, 8 mm, 10 mm, 12 mm, 14 mm, 16 mm, 18 mm, 20 mm, 22 mm, 24 mm, 26 mm, 28 mm, 30 mm, 32 mm, etc.

[0087] In one embodiment, the holes may be configured in a plurality of two or more, for example, three, four, five, six, seven, eight, or more. For example, FIG34 illustrates six holes 480, FIG36 illustrates 24 holes 480, FIG37 illustrates eight holes 480, FIG39 illustrates four holes 480, and FIG35 illustrates a greater number of holes 480. This does not limit the number of holes. In some examples, the holes are configured in an even number and are symmetrically distributed. For example, in FIG34 , six holes 480 are configured and the distribution of the six holes 480 is axisymmetric. In FIG39 , four holes 480 are configured and the distribution of the four holes 480 is axisymmetric. In some examples, the holes are configured in an odd number and are evenly distributed, that is, the holes are arranged at even intervals.

[0088] In the usage scenario of the inhaler, the user's misoperation may be to unconsciously or unknowingly place the thumb or index finger on the end face of the proximal end of the inhaler upper shell. In this case, the user's finger is usually placed on the end face of the proximal end of the inhaler upper shell from the side of the inhaler away from the user's face or the right or left side of the inhaler. Then the holes on the rear side, right side or left side of the end face of the proximal end of the inhaler upper shell are inevitably blocked or partially blocked. Therefore, in one embodiment of the present application, on the proximal end face of the inhaler, the width of the holes located on the front side is greater than the width of the holes on the other sides. In this way, when the finger covers the proximal end face from the rear side of the proximal end face toward the front side during user misoperation, it can be ensured that the covered holes (i.e., the holes located on the rear side or other sides) are holes with smaller air intake areas, and the uncovered holes (at least including the holes located on the front side) are holes with larger air intake areas, thereby ensuring that the airflow intensity is maximized. The front side refers to a side close to the mouthpiece of the inhaler, and the rear side refers to a side opposite to the front side and away from the mouthpiece of the inhaler. When the user is using the inhaler, the front side is usually closer to the user's face.

[0089] In some embodiments, the annular arrangement can be configured as a symmetrical distribution. For example, it can be axially symmetrical, rotationally symmetrical, or centrally symmetrical. In some embodiments, the annular arrangement corresponding to the annular shape can be configured as a circular annular shape, a nearly polygonal annular shape, or an irregular annular shape. Taking a circular annular shape as an example, each hole and each connecting portion can respectively correspond to a partial arc in a circle. Taking a nearly polygonal shape as an example, each hole can respectively correspond to an edge of a polygon, and each connecting portion can respectively correspond to a transition section between edges. As shown in Figure 34, the annular arrangement corresponds to a nearly hexagonal annular shape, wherein the six holes 480 configured respectively correspond to the six edges of the nearly hexagon, and the six connecting portions 481 respectively correspond to the transition section between edges.

[0090] In the embodiment shown in Figures 30 to 32, the annular arrangement of the at least two holes 480 can divide the proximal end surface into an end surface region A surrounded by the at least two holes and an end surface region B at the outer edges of the at least two holes. It should be noted that in other embodiments, the end surface region B may not be included. For example, the inner side of the end surface region is the end surface region A surrounded by the holes, and the outer side is the surrounded holes.

[0091] Furthermore, to ensure that the cover does not completely cover the main openings of each hole 480 on the proximal end face, in one embodiment, the inner diameter of end face region A is configured to be no less than the width of the cover. For example, if the cover is a user's finger, the inner diameter of end face region A is no less than the width of the finger. It should be understood that in the example where end face region A is a non-circular area, the inner diameter of end face region A being no less than the width of the cover means that the minimum inner diameter of end face region A is no less than the width of the cover. This ensures that no matter how the user covers the proximal end face, not all openings toward the proximal end face are completely covered. Therefore, all or part of the opening toward the proximal end face is always accessible to air, thereby ensuring that the inhaler can be used properly and properly.

[0092] For the convenience of user operation, in certain embodiments, in conjunction with Figure 34 and corresponding Figure 30, Figure 35 and corresponding Figure 31, Figure 36 and corresponding Figure 32, end face area B is configured as inclined-plane or cambered surface.In other embodiments, for example embodiment shown in Figure 33 and Figure 37, on the end face of the proximal end of upper housing 40, also can be distinguished as and comprise the end face area A positioned at center and the end face area B formed by extending outwardly by the end face area of ​​center, end face area B is configured as inclined-plane or cambered surface (not giving A and B mark in Figure 33 and Figure 37).Like this, at user's handheld inhaler, when hands were covered by the proximal end face of inhaler far-end towards upper housing 40, inclined-plane or cambered surface can form the transitional region that hand holds, helps to promote the user's sense of experience.

[0093] In one embodiment, the width of the end surface region B is configured to be any value between approximately 3 mm and 4.5 mm. For example, it can be configured to be 3 mm, 3.5 mm, 4 mm, 4.5 mm, etc. Preferably, it can be configured to be 3.92 mm.

[0094] In one embodiment, the end face region A and the end face region B are configured to be on different planes. In this way, the proximal end face of the upper shell 40 can be uneven, so that when the user covers the proximal end face, an air gap will inevitably be generated, further facilitating air entry. In some examples, the plane where the end face region B is located can be higher than the plane where the end face region A is located. As shown in Figure 35 and its corresponding Figure 31, the plane where the end face region B is located in the figure is higher than the plane where the end face region A is located. Each hole 480 is connected between the end face region A and the end face region B to achieve a transition between the regions. As shown in Figure 31, the annular arrangement of each hole 480 can be an overall arc shape so that the end face region B can gradually transition to the end face region A. In other examples, the plane where the end face region A is located can be higher than the plane where the end face region B is located. If the user makes an error, this structure will prevent the cover from completely fitting on the proximal end face, and an air gap will inevitably be formed at the bottom of the cover.

[0095] In some embodiments, a guide portion (also referred to as an identification portion) may be provided on the side wall of the main shell. The guide portion is used to prompt the user to hold the finger in this area, and can also be used to provide feedback information to the user, indicating that the user has operated correctly and can inhale. In some examples, the guide portion is configured as a convex point or a concave point, so that on the one hand, it can give the user a visual prompt, telling the user that the finger should be placed in this area, and on the other hand, it can also give the user a tactile prompt. When the user uses it, the finger touches the area to give the user feedback, telling the user that it has been placed in the correct position. Of course, in other examples, the guide portion can also be configured as a pattern mark to guide the user's operating habits from the user's visual perspective, and this application is not limited to this.

[0096] In any of the above-mentioned embodiments of the air inlet structure of the present application, by configuring the air structure to have at least two holes arranged in a ring shape, when the user holds the device during inhalation and places a finger on the proximal end, the main openings of all the holes cannot be completely covered, so that there is always airflow that can enter from the main opening, ensuring sufficient airflow, and further enabling the inhaler to operate normally. In order to illustrate the effect of the above-mentioned air inlet structure design, experimental data of test examples and comparative examples are provided herein.

[0097] Test case structure:

[0098] In the test example, the air inlet structure is configured as shown in Figure 39, including four holes 480, with adjacent holes 480 connected end to end via a connecting portion 481. The covering used in the test example is a finger that simulates the user's grip when using an inhaler to cover the end surface.

[0099] Please refer to FIG40, which is a schematic diagram showing the test example of the present application. As shown in the figure, in the test example, the proximal end surface of the upper shell of the inhaler is placed on the surface without covering and with covering areas of 1 cm 2 , 2cm 2 , 4cm 2 , 6cm 2 Under the conditions of , the inhalation gas flow rate of the inhaler mouthpiece was set to 20L / min, 40L / min, 60L / min, 80L / min, and 100L / min respectively for testing. The covering was a block obtained by shaping plasticine. In this test example, the airflow resistance test results of the air entering the structure in the test example are obtained, please refer to Table 1.

[0100] Table 1:

[0101] Comparative Example:

[0102] Please refer to FIG41 , which is a schematic diagram of an air inlet structure selected in a comparative example of the present application. As shown in the figure, in this comparative example, the air inlet structure is configured as an array of elongated holes formed in the housing, with the long sides of adjacent holes 70 facing each other, and each hole having a respective opening on the outer surface of the housing. These openings extend in the directions indicated by arrows V (toward the end surface) and H (horizontally) in FIG41 . Although the structure shown in this comparative example employs a grid-like or striped opening design, allowing for some gaps (e.g., gaps in the direction of arrow H) to allow air to enter through these gaps when the user's finger or thumb covers the opening of hole 70, due to the soft tissue of the user's finger or thumb, the tissue will also be trapped in the grid when covering hole 70. As a result, the actual gap space remaining is very small, resulting in high airflow resistance and insufficient power. This can cause the inhaler to fail to dispense a sufficient amount of drug solution, affecting the therapeutic effect without the user's knowledge.

[0103] Please refer to FIG42, which is a schematic diagram of the comparative example tested by the present application. As shown in the figure, the comparative example adopts the same test conditions and covers as the test example as the fingers used to simulate the user's grip posture of using the inhaler to cover the end surface, and the proximal end surface of the upper shell of the inhaler is placed without a cover and with a cover area of ​​1 cm 2 , 2cm 2 , 4cm 2 , 6cm 2 Under the conditions of , the inhalation gas flow rate of the inhaler mouthpiece was set to 20L / min, 40L / min, 60L / min, 80L / min, and 100L / min respectively for testing. In this comparative example, the covering was also selected by shaping the block obtained by plasticine. The test results of the air flow resistance of the air entering the structure in the comparative example are shown in Table 2.

[0104] Table 2:

[0105] In order to facilitate the comparison between Table 1 and Table 2, a line graph is formed based on the experimental data of Table 1 and Table 2. Please refer to Figure 43, which shows the line graphs of the gas flow resistance test in the test example and the comparative example of this application, wherein the line graph (a) in Figure 43 is the experimental data of the test example, and the line graph (b) in Figure 43 is the experimental data of the comparative example. In the line graphs (a) and (b) in Figure 43, the horizontal axis represents the gas flow rate (unit L / min), and the vertical axis represents the airflow resistance (unit min / L). The five lines from bottom to top correspond to no covering, covering area of ​​1 cm, and so on. 2 , 2cm 2 , 4cm 2 , 6cm 2Covering condition. From Figure 43, can draw, in 20L / min to 40L / min zone (can be understood as low flow area), along with the increase of covering area, the intake resistance in the comparative example also increases rapidly, and the test example resistance increase is not obvious. This is also to say, when the user is due to various factors such as disease or age and suction is less, for the inhaler corresponding to the comparative example, in case improper operation and larger covering is arranged to the end face of proximal end, the user will be subject to very large resistance, be difficult to start inhaler or enable insufficient. And for the inhaler corresponding to the test example, even if the user improper operation covers a larger area, the intake resistance influence of the air into structure is little, this is because the hole design of the air into structure that the test example adopts is arranged in an annular shape, when the covering simulates the finger of the user covering on the end face of proximal end, even if the coverage area is large, also can't cover all main openings completely, main opening can provide sufficient intake space, even if the user suction is less, also do not affect the use of inhaler.

[0106] Please refer to FIG44, which shows the line graphs of the gas flow resistance test in the test example and the comparative example of the present application, wherein the line graphs (a) to (e) in FIG44 are respectively without covering, with covering area of ​​1 cm 2 , 2cm 2 , 4cm 2 , 6cm 2 Comparison experimental data of the test example (represented by the dotted line) and the comparative example (represented by the solid line) under the covering condition, the horizontal axis represents the gas flow rate (unit L / min), and the vertical axis represents the airflow resistance (unit min / L). It can be seen from Figure 44 that when the gas flow rate continues to increase, the performance of the test example is also better than the comparative example. It can also be seen from Figure 44 that when the covering area is small, there is no obvious difference in the airflow resistance between the test example and the comparative example. However, as the covering area increases (for example, the user's finger is larger or incorrect operation), the airflow resistance of the test example is significantly lower than that of the comparative example. That is, the test example shows good airflow performance especially for large-area coverings. This is also because once the covering area of ​​the comparative structure is large, it will largely or completely cover the opening facing the V direction, and can only rely on some narrow gaps for air to enter. The holes of the air entry structure used in the test example are designed to be arranged in a ring shape. Even if the covering area is increased, since the covering simulates a finger, which is slender, when covering the proximal end face, a main opening with holes will inevitably be left in the ring, which can provide sufficient space for gas to flow in.

[0107] As described in the previous embodiments, when a user inhales through the mouthpiece, air can enter the inhaler via the air inlet structure described in any of the previous embodiments. The force retention unit also includes a breath-actuated mechanism housed in the upper housing. The airflow entering the inhaler can enter the breath-actuated mechanism, thereby causing the breath-actuated mechanism to activate the canister.

[0108] In one embodiment, the mechanism for breath actuation may include a compression spring 41, a flap valve assembly (not shown), a fixing ring 45, a diaphragm 46, and a lower cover 47. The compression spring 41, the flap valve assembly, the fixing ring 45, the diaphragm 46, and the lower cover 47 are mounted in the upper housing 40.

[0109] As shown in Figure 5, the flap valve assembly includes a flap valve housing 42, a flap valve 43, and a flap valve spring 44. Furthermore, the flap valve 43 includes a flap valve blade 430 and a flap valve seal 431. The flap valve 43 is rotatably mounted on the flap valve housing 42. For example, the flap valve 43 is rotatably mounted on the flap valve housing 42 via a connecting pin (not shown) provided on the flap valve housing 42. The flap valve spring 44 is disposed between the flap valve housing 42 and the diaphragm 46. The flap valve 43 is biased against the diaphragm 46 by the flap valve spring 44, so that the flap valve seal 431 seals against the diaphragm 46 in this biased position. When a user inhales through the mouthpiece 10, air enters the air intake structure and flows toward the mouthpiece 10. This airflow exerts a torsional force on the flap valve blade 430. When the torsional force generated by the airflow is sufficiently large, the flap valve 43 rotates.

[0110] In one embodiment, please refer to Figures 5 and 6. Figure 6 shows a schematic structural diagram of the diaphragm in one embodiment of the present application. As shown in the figure, the diaphragm 46 includes a rigid disk 460 and a flexible skirt 461. The rigid disk 460 is connected to the flap valve housing 42, and the flexible skirt 461 is connected to the rigid disk 460 and is clamped between the fixing ring 45 and the lower cover 47. In one embodiment, the rigid disk 460 is made of a rigid material, that is, the rigid disk 460 is made of a material with a certain strength. An example of the rigid material is acrylonitrile butadiene styrene. The flexible skirt 461 can be made of a flexible material, and the flexible skirt 461 made of the flexible material can undergo deformation such as elongation when subjected to force. An example of the flexible material is thermoplastic polyurethane. The rigid disk 460 and the flexible skirt 461 can be configured as an integral structure. For example, the diaphragm 46 can be made by multiple injection molding (for example, double injection molding), first using rigid material to perform injection molding to make the rigid disk 460, and then using flexible material to perform injection molding to make the flexible skirt 461 on the rigid disk 460. As a result, the rigid disk 460 and the flexible skirt 461 form an integral structure.

[0111] In one embodiment, the rigid disk 460 includes a valve hole. To distinguish the valve hole in the rigid disk 460 from the valve hole in the flexible skirt 461, the valve hole in the rigid disk 460 will be referred to as the first valve hole 4600 in the following embodiments. The first valve hole 4600 is located in the central region of the rigid disk 460. When sealed by the flap valve 43, the first valve hole 4600 creates a sealed cavity 7 between the diaphragm 46 and the lower cover 47. Furthermore, the rigid disk 460 includes a baffle 4601. This baffle 4601 is used to prevent air from flowing between the diaphragm 46 and the flap valve sealing portion 431.

[0112] In one embodiment, the rigid disk 460 further includes a boss 4603 disposed in the center of the rigid disk 460 and an outer wall 4604 disposed outside the rigid disk 460. The boss 4603 and the outer wall 4604 increase the rigidity of the rigid disk 460. The outer surface of the outer wall 4604 may further be configured to have a concave and convex area. The flap valve housing 42 is coupled to the outer wall 4604 and engages with the concave and convex area on the outer surface of the outer wall 4604. To facilitate positioning of the diaphragm 46, the rigid disk 460 further includes a positioning member 4602. The positioning member 4602 engages with the flap valve housing 42 to position the diaphragm 46 in the engaging position of the flap valve housing 42.

[0113] As shown in Figure 5, the flexible skirt 461 is arranged between the fixing ring 45 and the lower cover 47 and is connected to the rigid disk 460. When the fixing ring 45 moves toward the distal end, the flexible skirt 461 is pressed down and deformed by the fixing ring 45 (for example, from a wrinkled state to an unfolded state), thereby increasing the volume of the sealing cavity 7, so that the sealing cavity 7 has a negative pressure when it is sealed, thereby increasing the sealing between the diaphragm 46 and the flap valve sealing part 431.

[0114] In one embodiment, as shown in Figures 5 and 6, the flexible skirt 461 includes a flexible annular curved portion 4610, a flexible connecting ring 4611, and a second valve hole 4612. The flexible skirt 461 is disposed between the fixing ring 45 and the lower cover 47 via the flexible connecting portion 4611. The flexible annular curved portion 4610 is located in a recessed area of ​​the lower cover 47. The second valve hole 4612 is defined in the flexible skirt 461 and communicates with the first valve hole 4600.

[0115] Please continue to refer to FIG. 7 in conjunction with FIG. 2 , which shows a schematic structural diagram of a bracket according to one embodiment of the present application. As shown in the figure, the bracket 3 in the inhaler is used to connect to the force retaining unit 4 to position the force retaining unit 4, and can also be used to transfer force between other connected components and the force retaining unit 4. Specifically, the bracket 3 can be mounted on the canister 2 and connected to the lower cover 47.

[0116] In one embodiment, the bracket 3 includes a bracket body 32, a drive rod 30, and a support rod 31. The bracket body 32 is annular in structure and can be mounted on the tank 2. The support rods 31 are arranged on opposite sides of the distal end of the bracket body 32. When the dust cover 6 is closed, the support rods 31 are supported by the dust cover 6 to maintain the proximal state. The force retention unit 4 is then positioned under the action of the bracket body 32 to maintain the force retention unit in the proximal state. Furthermore, a reinforcement portion is provided on the support rod 31 in contact with the dust cover 6 to enhance the rigidity of the support rod 31. It should be noted that the force retention unit 4 is maintained in the proximal state when the lower cover 47 and the fixing ring 45 of the force retention unit 4 are in the proximal state, the compression spring 41 is in a compressed state, and the flap valve 43 seals the diaphragm 46. Although the number of support rods 31 is two in the embodiment shown in Figure 7, the number of support rods 31 can also be more than two in other embodiments. The driving rod 30 is located at the distal end of the bracket body 32 . As shown in FIG. 4 , the driving rod 30 can extend through a hole structure provided on the counting space 11 to drive the dose counter to count.

[0117] The following describes different states of the inhaler and the interactions between the force retaining unit, the bracket, and the canister in different states with reference to Figures 8 to 11. Figure 8 is a schematic diagram of the inhaler in a dormant state according to one embodiment of the present application, Figure 9 is a schematic diagram of the force retaining unit in the dormant state shown in Figure 8, Figure 10 is a schematic diagram of the inhaler in a ready state according to one embodiment of the present application, and Figure 11 is a schematic diagram of the force retaining unit in an activated state according to one embodiment of the present application.

[0118] When the inhaler is in a dormant state, that is, when the dust cover 6 is in a closed state, the raised portion 60 on the dust cover 6 cooperates with the support rod 31 of the bracket to lock the bracket 3 in the proximal state. The bracket 3 in the proximal state will resist the force retention unit so that the force retention unit is in the proximal state. Specifically, the bracket 3 resists the lower cover 47 of the force retention unit and further fixes the compression spring 41 via the fixing ring 45. At this time, there is an axial gap 8 between the lower cover 47 and the tank 2. The compression spring 41 is in a fully compressed state (the fully compressed state refers to the compression of the compression spring to the maximum degree of compression during the entire operation of the inhaler) to store energy, and the flap valve 43 seals the first valve hole 4600 of the diaphragm 46 to form a sealed cavity 7 between the diaphragm 46 and the lower cover 47.

[0119] Inhaler enters standby mode from dormant mode, corresponding to the operation of opening dust cover 6, described support 3 can move toward distal end (this action gives space for compression spring 41 to release energy), compression spring 41 releases energy to push lower cover 47 and described fixing ring 45 to move toward distal end, thereby, the flexible skirt 461 of diaphragm 46 is unfolded from folded state under the clamping of lower cover 47 and fixing ring 45, further, the annular curved portion 4610 of flexible skirt 461 is unfolded. Like this, the volume of sealing cavity 7 between described lower cover 47 and diaphragm 46 increases, and when described sealing cavity 7 is sealed, it is negative pressure in described sealing cavity 7, and then can increase the sealing between diaphragm 46 and described flap valve sealing portion 431. Negative pressure in described sealing cavity 7 also produces the active force towards proximal end, to resist the active force towards distal end that described compression spring 41 produces. The movement of the compression spring 41 toward the distal end stops after the force acting toward the distal end is balanced with the force acting toward the proximal end (the force acting toward the proximal end is mainly the force acting toward the proximal end generated by the sealing cavity 7). It should be noted that when the dust cover 6 is opened, the bracket 3 moves toward the distal end, which means that the bracket 3 has a movement toward the distal end when the dust cover 6 is opened, and does not mean that the bracket 3 must only have a movement toward the distal end. Taking into account the coordination between structural designs, etc., the bracket 3 is also allowed to have a movement toward the proximal end during the process of opening the dust cover 6. It is only necessary to ensure that when the dust cover 3 is opened, the amount of movement of the bracket 3 toward the distal end is greater than the amount of movement toward the proximal end.

[0120] What should be explained here is, in the force balance of the compression spring 41 that the foregoing description describes, only considered main active force, for some small active forces that influence each other between each structure in the inhaler and compression spring 41 are produced are not considered.For example, in some examples, when lower cover 47 is towards distal motion, lower cover 47 can occupy the axial gap 8 between described lower cover 47 and described jar 2 when dust cover 6 is closed and begins to slightly press jar 2, makes jar 2 slightly compress its valve stem 22 (this slight compression is not enough to make medicinal solution discharge from valve stem 22, does not affect user use), now, valve stem 22 can produce small active force towards proximal end.The small active force of giving example is only a kind of example, also possible lower cover 47 can just contact jar 2 and do not produce the active force towards proximal end, or other small active forces that influence each other and produce between other structures of inhaler, because these small active forces are very weak to the contribution of force balance, therefore, in the embodiment of the application, is to describe the force balance of compression spring 41 with ignoring these small effects.

[0121] Inhaler enters start-up state by ready state, correspond to user by described mouthpiece 10 air-breathing, at this moment, air can enter and form the air flow towards mouthpiece 10 in described inhaler from described air entry structure, when air flow acts on the torsional force on the described flap valve blade 430 greater than described flap valve spring 44 and described sealing cavity 7 act on the torsional force on the described flap valve blade 430, after described flap valve 43 rotates, thereby flap valve sealing portion 431 opens described barrier film 46, air enters described sealing cavity 7, at this moment, the air pressure in the described sealing cavity 7 is transformed into atmospheric pressure by negative pressure state.Like this, the active force towards proximal end that negative pressure produces in the sealing cavity 7 disappears, and the force balance under the ready state is broken.And then described compression spring 41 further extends (promptly further releasing energy).Along with the further extension of described compression spring 41, described lower cover 47, retaining ring 45 and support 3 further move towards far-end, cause the relative valve stem 22 of tank body 20 to move to far-end. Then, the valve stem 22 can enter the quantitative chamber so that the drug solution in the quantitative chamber is sprayed out from the valve stem 22 in a mist form, until the valve stem 22 continues to move to the stop portion inside the valve 21, and then the valve stem 22 stops moving.

[0122] Furthermore, the user can reset the inhaler by closing the dust cover 6. At this time, the bracket 3 is pushed by the dust cover 6 to move toward the proximal end, further causing the force holding unit to move toward the proximal end. As a result, the flexible skirt 461 of the diaphragm 46 in the force holding unit gradually returns to its original state and discharges the gas from the sealing cavity 7. Then, under the action of the flap valve spring 44, the flap valve 43 rotates and continues to seal the diaphragm 46, so that the sealing cavity 7 is in a vacuum state.

[0123] It should be noted that the force retaining unit and the bracket are not limited to the structures of the embodiments shown in Figures 1 to 7 of the present application, and can also be made of other mechanical structures. For example, as long as it can be ensured that when the user inhales, the force retaining unit can activate the tank 2 so that the valve stem 22 can enter the quantitative chamber (that is, the drug solution in the quantitative chamber can be sprayed out from the valve stem 22 in the form of mist).

[0124] As shown in FIG2 , the dose counter 5 is disposed within the main housing 1 and further disposed within a counting space 11 of the main housing 1 for counting the number of times the inhaler has been used. It should be understood that the configuration of the dose counter 5 within the breath-actuated inhaler shown in FIG1 and FIG2 is merely an exemplary illustration. In other embodiments, the dose counter 5 may also be configured within any non-breath-actuated inhaler, such as one that is manually actuated, actuated by an additional actuator, or actuated electronically. The subsequent embodiments illustrate the operating principle of the dose counter 5 within a breath-actuated inhaler and do not limit the scope of inhalers to which the dose counter 5 is applicable.

[0125] Refer to Figure 12 and Figure 13, be shown as the structural representation of the dose counter of the application in different embodiments respectively, as shown in Figure 12 and Figure 13, described dose counter 5 comprises actuating mechanism 50 and counting assembly 51.Described actuating mechanism 50 is towards distal motion when driven, and described counting assembly 51 can count the number of times of use of described inhaler based on described actuating mechanism 50 towards distal motion, and with the number of times of use of described inhaler of visual digital indication.Wherein, described actuating mechanism 50 can be driven in response to different driving operations according to the difference of the actuating mechanism of the inhaler that it applies, for example, actuating mechanism 50 can be driven towards distal motion in response to user's suction, manual triggering operation, action mechanism triggering operation or electric control device electric triggering etc.

[0126] In one embodiment, the actuating mechanism 50 is configured to be driven toward distal motion in response to the user's inhalation. In an example in which the main housing, tank, force retaining unit, and support of the inhaler are arranged as shown in any one of the embodiments of Figures 1 to 11, the actuating mechanism 50 is further driven toward distal motion by the support or the actuating mechanism 50 follows the support toward distal motion as a part of the support when the support is driven. In other examples, the actuating mechanism 50 may also be driven toward distal motion by a structure that can have a linkage relationship with the above structure or unit, and the present application does not limit this.

[0127] In one embodiment, as shown in Figure 12, the actuating mechanism 50 includes a driving member 500 and a return spring 501. For example, when the bracket 3 (specifically the driving rod 30 of the bracket 3) shown in Figure 7 moves toward the distal end, the driving member 500 is driven to move toward the distal end and compress the return spring 501. When the bracket 3 moves toward the proximal end, the return spring 501 can extend and cause the driving member 500 to move toward the proximal end. Further, please refer to Figure 14, which is a schematic diagram of the state of the actuating mechanism of the present application moving toward the distal end in the embodiment shown in Figure 12. As shown in the figure, the driving member 500 includes a driving claw 5000 for driving the counting assembly 51, which can contact the counting assembly 51 to drive the counting assembly 51 when the actuating mechanism 50 moves toward the distal end.

[0128] In one embodiment, as shown in FIG13 , the actuating mechanism 50 includes a driving member 500, which is configured as a hook formed on the bracket 3. The hook is further formed on the driving rod 32 of the bracket 3. When the driving member 500 is driven (i.e., when the bracket 3 is driven), the driving member 500 moves toward the distal end, so that the driving member 500 can contact the counting assembly 51 to drive the counting assembly.

[0129] In one embodiment, as shown in Figures 12 and 13, the counting assembly 51 includes a first counting unit 510 and a second counting unit 511. The first counting unit 510 is driven by the actuating mechanism 50 to count a first set of numbers when the actuating mechanism 50 moves toward the distal end, and drives the second counting unit 511 to count a second set of numbers when the first counting unit 510 counts a preset number of times. The first counting unit 510 and the second counting unit 511 cooperate to visually indicate the number of times the inhaler has been used.

[0130] The visualized numbers may be Arabic numerals, or may be numbers represented by Chinese characters or English. This application does not limit the language form of the numbers. In the following embodiments of this application, the visualized numbers are illustrated as Arabic numerals.

[0131] The preset number of times is related to the timing of the carry between the first group of numbers and the second group of numbers. In one embodiment, the preset number of times includes a number determined based on the carry relationship between the first group of numbers and the second group of numbers in the visualized number, which can reflect the timing of the nth (n is an integer greater than 1) carry of the first group of numbers to the second group of numbers. Taking the decimal relationship between the first group of numbers and the second group of numbers as an example (in this example, the first counting unit can also be called the ones digit counting unit, and the second counting unit can also be called the tens digit counting unit), the preset number of times is set to a positive integer multiple of 10 (i.e., 10, 20, 30...) plus the number of counts of the first carry. Taking the first carry as the first count as an example, the first counting unit can drive the second counting unit to count when performing the 10th positive integer multiple plus 1 count. In one embodiment, the preset number of times also includes the number of counts corresponding to the first carry determined according to the initial value of the visual number. Specifically, based on the initial value and the carry relationship between the two groups of numbers, the timing of the first carry of the first group of numbers to the second group of numbers can be determined. Taking the initial value of the visual number as 120 as an example, the preset number of times also includes the first time, that is, when the first counting unit performs the first count, it will drive the second counting unit to count; taking the initial value of the visual number as 111 as an example, the preset number of times also includes the second time, that is, when the first counting unit performs the second count, it will drive the second counting unit to count; taking the initial value of the visual number as 112 as an example, the preset number of times also includes the third time, that is, when the first counting unit performs the third count, it will drive the second counting unit to count.

[0132] In one embodiment, the counting component 51 can be used to indicate the number of uses remaining in the inhaler, or the number of uses already completed. For example, if the counting component 51 currently displays the number 99 and the user uses the inhaler once, if the counting component 51 indicates the number of uses remaining, the counting component 51 will display 98; if the counting component 51 indicates the number of uses already completed, the counting component 51 will display 100.

[0133] In embodiments where the counting assembly 51 is used to indicate the number of uses, the visual number displayed by the counting assembly is a positive number. In this embodiment, in the initial state of the inhaler, the number indicated by the first and second counting units in conjunction indicates that the inhaler has not been used since leaving the factory, for example, indicating the number 0. After a single use, the counting assembly 51 counts once and increments the number, for example, indicating the number 1.

[0134] In the embodiment in which the counting assembly 51 is used to indicate the remaining number of uses, the visual digital presented by the counting assembly is counted in reverse. In the present embodiment, in the initial state of the inhaler, the first counting unit and the second counting unit cooperate to indicate the total number of uses (i.e., the total number of uses when leaving the factory) of the inhaler in the initial state. As shown in Figure 13, the total number of uses of the inhaler in the initial state is displayed as numeral 120. After using once, the counting assembly 51 counts once, which reduces a number and is displayed as numeral 119. In this way, the user can see the remaining amount of the inhaler at each viewing, which helps the user to instantly understand the remaining service life of the inhaler and to make preparations in time. Of course, Figure 19 only shows the number of uses of the inhaler after it leaves the factory. It can also indicate the number of uses of the inhaler during the production stage test. Still taking the display number shown in Figure 13 as an example in the initial state, that is, after the use in the production stage test, the counting component cooperates to display the number 120. Therefore, the counting component needs to display a number larger than the number 120 so that the use in the production stage test prompts the counting component to count down to 120. For example, in the production stage, the counting component cooperates to display the number 130, and can be used 10 times for testing. In the 10 tests, the first counting unit and the second counting unit cooperate to display integers from 129 to 120 in sequence (that is, 129, 128, 127, 126, 125, 124, 123, 122, 121, 120 are displayed in sequence). These integers and the starting value 130 are used to indicate the number of uses of the production stage test.

[0135] In the subsequent embodiments, the visualization of numbers in a countdown manner is used as an example for illustration, which should not be understood as a limitation to the present application.

[0136] Wherein, the place value of first group of digits and second group of digits is relevant to the total use number of inhaler.Be two digits (for example 99) as the total use number of inhaler, the place value of first group of digits and second group of digits superposition need at least have two digits, in the present example, said first group of digits can be set to one, and said second group of digits can be set to one.Be three digits (for example 120) as the total use number of inhaler, the place value of first group of digits and second group of digits superposition need at least have three digits, in the present example, said first group of digits can be set to one, and said second group of digits can be set to two, and said first counting unit and second counting unit cooperate with the use number of times in the described inhaler of three digits indication.Particularly, be 120 times as the total use number of inhaler, and said first group of digits comprises totally ten single-digit numbers of 0 to 9. The second group of numbers includes at least 13 numbers from 0 to 12. In this way, the first group of numbers and the second group of numbers can be combined to display a single digit, a double digit, or a triple digit. That is, the first group of numbers and the second group of numbers can be combined to display at least all whole digits from 0 to 120, that is, at least 0, 1, 2, 3..., 119, 120 can be displayed.

[0137] Wherein, the total use number of times of inhaler can be set to and only comprises the total use number of times of initial state, also can be set to comprise the total use number of times of production stage test and the total use number of times of initial state.For example, the total use number of times of inhaler is for being configured as total use number 120 times under the initial state, and the second group of digits can just comprise 0 to 12, so cooperates with the first group of digits and can just show 120,119 ..., 3,2,1,0, to indicate the use number of times of inhaler after leaving the factory.For another example, the total use number of times of inhaler also comprises the total use number of times of production stage test 10 times, then the second group of digits need to comprise greater than 12 more numerals to also show in the production stage of inhaler, that is, the second group of digits comprises 0 to 13, cooperates with the first group of digits and can show 130,129 ..., 120,119 ..., 3,2,1,0, wherein, 130,129 ..., 121,120 can show in the production stage of inhaler, and after leaving the factory, inhaler shows 120,119 ..., 3,2,1,0. Of course, in other examples, the digital display may not be configured during the production test phase, that is, 13 is not set, and only a blank position is reserved. When the total number of uses of the inhaler is a two-digit number, this can also be understood and set in a similar manner, which is not detailed here.

[0138] In one embodiment, a propulsion unit can be provided so that when the first counting unit 510 counts a preset number of times, the second counting unit can be driven to count a second set of numbers. As shown in Figures 12 and 13, the counting component 51 also includes a propulsion unit 512 engaged with the second counting unit 511. When the first counting unit 510 counts a preset number of times, it engages with the propulsion unit 512 so as to drive the second counting unit 511 to count through the propulsion unit 512. In other words, when the first counting unit 510 is engaged with the propulsion unit 512, and after the propulsion unit 512 is engaged with the second counting unit 511, the movement of the first counting unit 510 can drive the movement of the second counting unit 511. Here, engagement refers to a combination method of mutual contact and cooperation to produce linkage, for example, snap-fitting, meshing, etc.

[0139] In one embodiment, please refer to FIG15 , which is a schematic diagram of the structure of a propulsion unit in one embodiment of the present application. As shown in the figure, the propulsion unit 512 includes a first gear 5120 and a second gear 5121 in a linkage relationship. As shown in conjunction with FIG12 and FIG13 , when the first counting unit 510 counts a preset number of times, the first gear 5120 is driven by the first counting unit 510 to drive the second gear 5121 to rotate. The second gear 5121 is engaged with the second counting unit 511 to cause the second counting unit 511 to count when rotating. In one example, the first gear 5120 and the second gear 5121 can be fixedly connected by a connecting rod 5122. When the first gear 5120 is driven to rotate by the first counting unit 510, the connecting rod 5122 further drives the second gear 5121 to rotate, thereby driving the second counting unit 511 to count.

[0140] In one embodiment, refer to Figure 16, be shown as the first counting unit and the second counting unit split structure schematic diagram in one embodiment of the present application, as shown in the figure, the first counting unit 510 comprises the first counting wheel 5101 that is marked with the first group of numbers on the circumference, and the second counting unit 511 comprises the second counting wheel 5110 that is marked with the second group of numbers on the circumference.Wherein, the first counting wheel 5101 and the second counting wheel 5110 are arranged side by side, and the first counting wheel and the second counting wheel respectively present their respective corresponding numbers in the display window by rotation when being driven, so as to indicate the number of times of use of the inhaler by the digital combination of the two groups of numbers.For example, when using 1 time, the first counting wheel 5101 carries out the change of 1 number by rotation and rotates the changed number into the display window, when the first counting wheel 5101 rotates a preset number of times, the second counting wheel 5110 carries out the change of 1 number by rotation and displays the changed number into the display window, and the number formed after the two groups of numbers are combined indicates the number of times of use.Wherein, the display window is the window that allows light beam to enter on the inhaler, so that the user can observe the number displayed on the counting wheel through the display window.

[0141] It should be noted that, although the present application marks the numbers on the counting wheel, it is not limited to this. In other embodiments, the first group of numbers and the second group of numbers can also be set on a belt that can be unwound with the reel.

[0142] In one embodiment, as shown in FIG16 , the second counting unit 511 includes, in addition to the second counting wheel 5110, a second actuating gear 5111 for coupling with the propulsion unit. The second actuating gear 5111 has a plurality of teeth spaced apart circumferentially. The propulsion unit drives one of the teeth in the second actuating gear 5111 to move, causing the second counting wheel 5110 to rotate by one count. Specifically, the second counting wheel 5110 and the second actuating gear 5111 are linked, and the two may be directly or indirectly connected, or may be formed as an integral structure.

[0143] The number of teeth on the second actuating gear 5111 is related to the number of digits in the second set of digits and must be no less than the number of digits in the second set of digits. For example, if the second set of digits includes the 13 digits 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12, then the number of teeth on the second actuating gear 5111 should be no less than 13. For example, if the number of teeth on the second actuating gear 5111 is 14. For another example, if the second set of digits includes the 14 digits 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, and 13, then the number of teeth on the second actuating gear 5111 should be no less than 14.

[0144] In one embodiment, as shown in FIG16 , the first counting unit 510 further includes a shaft element 5100 distributed along the central axis of the first counting wheel 5101 and fixedly connected to the first counting wheel 5101. The second counting wheel 5110 is sleeved on the shaft element 5100 to be rotatably supported by the shaft element 5100. Furthermore, when the second counting unit 511 includes a second actuating gear 5111, the second actuating gear 5111 may also be sleeved on the shaft element 5100.

[0145] Please refer to Figures 17 and 18 , which respectively illustrate schematic structural diagrams of the first counting unit in various embodiments. As shown in Figures 17 and 18 , the first counting unit 510 further includes a first actuating gear 5102 fixed to the shaft element 5100, having a plurality of teeth spaced circumferentially. The actuating mechanism abuts against one of the teeth, causing the first counting wheel 5101 to rotate by one count when the actuating mechanism moves distally. Specifically, referring to Figure 17 in conjunction with Figure 14 , the driving pawl 5000 of the actuating mechanism 50 abuts against one of the teeth of the first actuating gear 5102, causing the first counting wheel 5101 to rotate by one count when the driving pawl 5000 moves distally. Referring to Figure 18 in conjunction with Figure 13 , the driving member 500 of the actuating mechanism 50 abuts against one of the teeth of the first actuating gear 5102, causing the first counting wheel 5101 to rotate by one count when the driving member 500 moves distally. In one embodiment, when the first group of numbers in the first counting unit 510 is set to 1, the first group of numbers marked on the first counting wheel includes ten integer numbers, namely 0, 1, 2, 3, 4, 5, 6, 7, 8, and 9. The gear has 10 teeth corresponding to the ten integer numbers, and each tooth corresponds to a number in the first group of numbers. That is, when a tooth is driven, the number corresponding to the tooth will be rotated to a position observable by the user, for example, rotated into the display window described below.

[0146] In one embodiment, as shown in Figures 17 and 18 , the first counting unit 510 further includes a single-tooth element 5103. The single-tooth element 5103 is fixed to the shaft element 5100 or the first actuating gear 5102 so as to rotate with the shaft element 5100 or the first actuating gear 5102. When the first counting unit 510 counts a preset number of times, the single-tooth element 5103 rotates in contact with the propulsion unit to propel the second counting wheel 5110. In the example shown in Figures 12 and 13 , where the propulsion unit 512 is located on the upper side, the single-tooth element 5103 is located below the first gear 5120 of the propulsion unit 512. It should be noted that the single-tooth element 5103 may also be located in different locations depending on the structure and installation position of the propulsion unit. For example, if the propulsion unit 512 is located below the first counting unit 510 and the second counting unit 511, the single-tooth element 5103 may be located above the propulsion unit 512.

[0147] Furthermore, referring to Figures 14 and 15 , the pusher unit is configured as including a first gear 5120 and a second gear 5121, and the manner in which the single-tooth element 5103 drives the second counting wheel 5110 to count is described as an example. Specifically, when the actuator 50 is driven, it interacts with one tooth of the first actuating gear 5102, causing the first actuating gear 5102 to rotate, thereby rotating the first counting wheel 5101 together with the single-tooth element 5103. This means that the first counting assembly 51 as a whole undergoes one rotation, and one rotation corresponds to one count of the first counting wheel. Before each count of the preset number of times, the single-tooth element 5103 moves to a pre-engagement position, as shown by the current state of the single-tooth element 5130 in FIG. 14 . Then, when counting the preset number of times, the single-tooth element 5103 rotates with the first actuating gear 5102 past the tooth in the pre-engagement position of the first gear 5120 of the pushing unit 512, thereby pushing the tooth away from the pre-engagement position. This causes the first gear 5120 of the pushing unit 512 to rotate once, and the second gear 5121, in turn, pushes the second counting wheel 5110 to rotate once. When the single-tooth element 5103 pushes the tooth in the pre-engagement position of the first gear 5120 away from the pre-engagement position, the next tooth of the first gear 5120 moves to the pre-engagement position, ready to contact the single-tooth element 5130 when it returns to this position, thereby performing the next count of the second counting wheel.

[0148] Taking the initial state where the counting component displays the number 120 as an example, the preset number includes the first time and the counting number of positive integer multiples of 10 plus 1, for example, including the 1st time, 11th time, 21st time, 31st time, 41st time, 51st time, 61st time, 71st time, 81st time, 91st time, 101st time, 111th time, and 121st time. Before the first count, the single-tooth element 5103 and the first tooth of the first gear 5120 are located in the preset engagement position, so that when the first count is performed, the single-tooth element 5103 pushes the first tooth to cause the pushing unit to rotate once, thereby prompting the second counting wheel to rotate once, and the counting component displays the number 119. Thereafter, the second tooth of the first gear 5120 is in the preset engagement position, and the single-tooth element 5103 leaves the preset engagement position. During the second to tenth counts, the single-tooth element 5103 follows the movement once each time, reaching the preset engagement position again upon completion of the tenth count. Thus, during the eleventh count, the single-tooth element 5103 pushes the second tooth, causing the pusher unit to rotate a second time, thereby causing the second count wheel to rotate a second time, and the counting assembly displays the number 109. This cycle continues until, during the eleventh count, the single-tooth element 5103 pushes the twelfth tooth, causing the pusher unit to rotate a twelfth time, thereby causing the second count wheel to rotate a twelfth time, and the counting assembly displays the number 9. During the 121st count, the counting assembly displays the number 0, indicating that the count has exceeded the maximum number of counts. In some embodiments, such as those including a signaling element, the single-tooth element 5103 pushes the thirteenth tooth, causing the pusher unit to rotate a thirteenth time, thereby causing the second count wheel to rotate a thirteenth time, causing the signaling element to obscure the display of the counting assembly.

[0149] It should be understood that the preparatory engagement position refers to the position corresponding to the transmission movement between the single-tooth element and the propulsion unit. It does not represent a fixed position, but rather indicates that in the preparatory engagement position, the continued movement of the single-tooth element can contact and propel the propulsion unit. Furthermore, FIG14 illustrates the manner in which the single-tooth element 5103 drives the second counting wheel 5110 to count, using the configuration of the actuating mechanism 50 as shown in FIG12 as an example. When the actuating mechanism 50 adopts the configuration shown in FIG13, the principle of the single-tooth element 5103 driving the second counting wheel 5110 to count is the same as in FIG14 and will not be further described here.

[0150] In order to prevent further counting of the dose counter after the inhaler has reached the maximum number of uses, in one embodiment, a stop structure is provided on the first gear of the propulsion unit. When counting exceeds the maximum number of times, the single-tooth element pushes the first gear to rotate the stop structure to the preset engagement position to stop the driving effect of the single-tooth element on the propulsion unit, or, it can also be described as causing the propulsion unit to lose contact with the single-tooth element.

[0151] Please refer to Figure 19, which is a structural schematic diagram of the propulsion unit in one embodiment of the present application. Figure 20 is a functional state diagram of the stop structure in the propulsion unit shown in Figure 19 of the present application. As shown in Figures 19 and 20, a stop structure 5123 is configured on the first gear 5120 of the propulsion unit 512. When the count exceeds the maximum number of uses (i.e., the count corresponding to the maximum number of uses), the stop structure 5123 rotates to the preparatory engagement position (as shown in the states (b) and (c) in Figure 20) so that the first gear 5120 cannot contact the single-tooth element 5103, thereby stopping the driving action of the single-tooth element 5103 on the propulsion unit 512, and the second counting wheel can no longer be counted. In a specific example, the stop structure 5123 is configured as a toothless portion (or recessed portion) on the first gear 5120, and the toothless portion is located behind the last tooth 51200 of the first gear 5120. The last tooth 51200 corresponds to the tooth that is pushed and rotated by the single-tooth element 5103 when the maximum number of uses is exceeded. Before the count exceeds the maximum number of uses, the single-tooth element 5103 and the first gear 5120 are in the state shown in (a) of Figure 20, and the last tooth 51200 and the single-tooth element 5103 are in a pre-engagement position, so that when the last count is performed, the single-tooth element 5103 The last tooth 51200 is pushed to rotate so that the second counting wheel rotates once, which causes the last tooth 51200 to leave the preset engagement position, and the stop structure 5123 reaches the preset engagement position (as shown in Figure 20 (b)). The stop structure 5123 reaches the preset engagement position, which prevents the first gear 5120 from contacting the single-tooth element 5103. Even if the single-tooth element 5123 moves to the preparatory engagement position again (as shown in Figure 20 (c)) for the next count, the single-tooth element 5123 can only pass through the stop structure 5123 without contact.

[0152] Continuing with the aforementioned counting component displaying the number 120 in the initial state, the preset times include the 1st, 11th, 21st, 31st, 41st, 51st, 61st, 71st, 81st, 91st, 101st, 111th, and 121st times as an example to illustrate the pushing unit 512 shown in Figure 19. The count exceeding the maximum number of uses corresponds to the aforementioned 121st count. At this time, the single-tooth element 5103 pushes the first gear 5120 to make the stop structure 5123 located in the preparatory engagement position. Therefore, when continuing to count after the 121st time, the single-tooth element 5123 will no longer be able to contact the pushing unit 512 and will no longer have a driving effect on the pushing unit 512.

[0153] It should be stated here that in the embodiment where the counter also includes the signal element described later, the pushing unit shown in Figures 19 and 20 enables the second counting unit to rotate once when counting exceeds the maximum number of uses, so that the signal element can block the display of the counting component (please refer to the subsequent embodiment including the signal element for details, which will not be repeated here). Therefore, even if the first counting unit is rotating or moving, it will not be observed by the user.

[0154] In one embodiment, the actuator 50 moves distally so that when the counting assembly 51 counts, the corresponding number on the first counting wheel 5101 is offset from the correct display position in the display window. For example, referring to Figures 12, 13, and 21, Figure 21 shows a schematic diagram of a counting assembly in one embodiment of the present application showing a number displayed offset from the display window. As shown in the figure, when the driving member 500 of the actuator 50 moves distally, it drives the first counting wheel 5101 to rotate clockwise. After the movement stops, the number on the first counting wheel 5101 (e.g., the number 9 in Figure 21) is offset from the center position C of the display window 56.

[0155] When the actuator 50 moves proximally to reset, it causes the first counting wheel 5101 to rotate in a direction opposite to the counting direction, so that the corresponding number on the first counting wheel 5101 is displayed at the correct position in the display window. For example, referring to Figures 21 to 23 in conjunction with Figures 8 and 12, Figure 22 shows a schematic diagram of the actuator moving proximally in the embodiment shown in Figure 12 of the present application, and Figure 23 shows a schematic diagram of the counting assembly in one embodiment of the present application correctly displayed in the display window. After the user inhales a dose of the drug, the dust cover 6 is closed. As the dust cover 6 rotates to the closed position, the raised portion 60 of the dust cover 6 supports the bracket 3, thereby causing the drive mechanism 500 of the actuator 50 to move proximally under the action of the reset spring 501. When the actuator 50 moves proximally, it can cause the first counting wheel 5101 to rotate in a direction opposite to the counting direction (e.g., counterclockwise), so that the number on the first counting wheel 5101 is displayed at the correct position in the display window (i.e., the center of the display window). When the actuator 50 moves proximally, its drive pawl 5000 deforms toward the actuator 50, passing over the next tooth on the first actuating gear 5102 (the tooth adjacent to the currently engaged tooth and closer to the proximal end) and engaging with the next tooth. The next time the actuator 50 moves distally, the drive pawl 5000 can continue to drive the first count wheel 5101 to rotate via the tooth it engages with. As shown in Figures 21 and 23, when the actuator 50 moves proximally, the drive pawl 5000 engages with the teeth on the first actuating gear 5102 and drives the first count wheel 5101 to rotate clockwise. After the actuator 50 stops moving, the number 9 on the first count wheel 5101 shifts toward the center of the display window. When the actuator 50 moves proximally, the drive pawl 5000 disengages the currently engaged tooth and engages with the next tooth, causing the number 9 on the first count wheel 5101 to be displayed in the correct position in the display window.

[0156] It should be understood that Figure 22 takes the actuating mechanism 50 configured as the structure shown in Figure 12 as an example to reset it so that the numbers are correctly displayed in the display window 56. The process of the actuating mechanism 50 adopting the structure shown in Figure 13 so that the numbers are correctly displayed in the display window 56 is similar to Figure 12. The only difference is that the actuating mechanism 50 in Figure 13 does not require a reset spring to help reset. Specifically, when the user closes the dust cover 6 after inhaling a drug, as the dust cover 6 rotates to the closed position, the raised portion 60 of the dust cover 6 supports the bracket 3. Since the driving member 500 included in the actuating mechanism 50 in Figure 13 is formed on the bracket 3, it can move proximally with the bracket 3. In this process, the driving member 500 uses a process similar to that shown and described in Figure 22 to enable the numbers to be correctly displayed in the display window 56.

[0157] It should be noted that after the actuator moves toward the distal end, if the first counting unit has counted a preset number of times, the second counting wheel 5110 is driven, and the numbers on the second counting wheel 5110 are also shifted to the center position of the display window. When reset, the numbers on the second counting wheel 5110 can also be displayed at the correct position in the display window.

[0158] In one embodiment, as shown in Figures 12 and 13, the counting assembly 51 further includes a bottom frame 513 for arranging the first counting unit 510 and the second counting unit 511. Please refer to Figure 24, which shows a schematic structural diagram of the counting assembly in one embodiment of the present application from one viewing angle. The bottom frame 513 may be provided with a first positioning claw 5130 corresponding to the first counting unit and a second positioning claw 5131 corresponding to the second counting unit. In one example, the first positioning claw 5130 and the second positioning claw 5131 are used to position the first counting unit 510 and the second counting unit 511, respectively, to ensure that the numbers on the first counting unit 510 and the second counting unit 511 are displayed in the center of the display window.

[0159] In some embodiments, the first positioning claw 5130 or the second positioning claw 5131 can be engaged with the teeth on the first actuating gear 5102 of the first counting unit 510 as shown in Figures 17 or 18 to abut against the teeth on the first actuating gear 5102 when the first actuating gear 5102 rotates counterclockwise, thereby preventing the first actuating gear 5102 from continuing to rotate counterclockwise. Similarly, the second positioning claw 5131 can be engaged with the teeth on the second actuating gear 5111 of the second counting unit 511 as shown in Figure 16 to abut against the teeth on the second actuating gear 5111 when the second actuating gear 5111 rotates counterclockwise, thereby preventing the second actuating gear 5111 from continuing to rotate counterclockwise.

[0160] In order to meet the requirements of space saving, rational layout, and compact structure, in one embodiment, as shown in Figure 18, the first counting unit 510 may also include a first stop gear 5104, and the first positioning claw 5130 cooperates with the first stop gear 5104 as shown in Figure 18 to prevent the reverse rotation of the first counting unit 510, wherein the first stop gear 5104 of the first counting unit 510 has a corresponding relationship with the first actuating gear 5102, that is, the teeth of the first stop gear 5104 correspond to the numbers on the first counting wheel 5101. In one embodiment, as shown in Figure 16, the second counting unit 511 may further include a second stop gear 5112, and the second positioning claw 5131 cooperates with the second stop gear 5112 as shown in Figure 16 to prevent the reverse rotation of the second counting unit 511, wherein the second stop gear 5112 of the second counting unit 511 has a corresponding relationship with the second actuating gear 5111, that is, the teeth of the second stop gear 5112 correspond to the numbers on the second counting wheel 5110.

[0161] Specifically, taking the first counting unit configured as shown in FIG18 and including a first stop gear 5104 as an example, when the first counting wheel 5101 rotates clockwise, a tooth on the first stop gear 5104 of the first counting unit can correspondingly pass over the first positioning pawl 5130. When the actuator 50 stops, the corresponding number on the first stop gear 5104 shifts from the correct display position in the display window, and the next tooth contacts the distal surface of the first positioning pawl 5130. For example, when the actuator 50 stops, the tooth corresponding to the number 8 on the first stop gear 5104 passes over the first positioning pawl 5130, while the tooth corresponding to the next number 7 contacts the distal surface of the first positioning pawl 5130 but does not pass over the first positioning pawl 5130. To reset, the first stop gear 5104 rotates counterclockwise, causing the tooth corresponding to the number 8 to engage with the first positioning pawl 5130, preventing the tooth corresponding to the number 8 from passing over the first positioning pawl 5130 in the reverse direction.

[0162] The first positioning claw 5130 and the second positioning claw 5131 can prevent the counting wheel from rotating excessively in the direction opposite to the counting direction, thereby ensuring the correct display of the dose. Furthermore, the correct display of the dose can be ensured even when the inhaler is dropped or shaken.

[0163] In one embodiment, the bottom frame 513 further includes mounting portions for securing the shaft element 5100 and / or the connecting rod 5122. The mounting portions are grooves, recesses, or similar structures. For example, referring to FIG. 22 in conjunction with FIG. 12 and FIG. 13 , the bottom frame 513 includes two symmetrically arranged first mounting portions 5132 for securing the shaft element 5100, and two symmetrically arranged second mounting portions 5133 for securing the connecting rod 5122.

[0164] In one embodiment, as shown in Figure 12 and Figure 13, dose counter also comprises signal element 514, and described signal element 514 is used for moving to the display window to prompt the user when the use frequency of inhaler reaches the preset use frequency.Particularly, signal element 514 links to each other with counting assembly 51, is driven by described counting assembly and is presented in described display window to prompt the user when the use frequency of inhaler reaches the preset use frequency.Described preset use frequency includes but is not limited to below 0 time and any number of times in the units place number of times and the tens place number of times.Be used to indicate the remaining use frequency in the described inhaler as example and illustrate with the visual numeral shown by described counting assembly in the following embodiments.

[0165] In one embodiment, please refer to Figures 25 and 26, which are schematic diagrams of the structures of signal elements in different embodiments of the present application. As shown in the figures, the signal element 514 includes a main body 5140, and the main body 5140 moves to the display window to prompt the user when the number of uses of the inhaler reaches a preset number of uses.

[0166] In one embodiment, the main body 5140 engages with the second counting unit so as to move to the display window as the second counting unit counts. Specifically, before the main body 5140 moves to the display window, it is located inside the dose counter (i.e., out of view of the user). As the second counting unit rotates, it can move from the inside to the display window. In one example, referring to FIG. 27 , which illustrates the engagement of a signal element and a second count wheel in one embodiment of the present application, the main body 5140 engages with the second count wheel 5110 of the second counting unit and rotates with the second count wheel 5110. For example, the main body 5140 is provided with an engaging portion 5142 that engages the second count wheel 5110 by engaging the engaging portion 5142 with the second count wheel 5110, such as by a splined engagement. It should be noted that the second counting unit can also be engaged with the main body 5140 in other ways or with other components in the second counting unit (such as the second actuating gear 5111), as long as the main body 5140 can be in contact with the second counting unit and driven by the second counting unit to move to a display window when the number of uses reaches a preset number of uses.

[0167] In one embodiment, as shown in Figures 25 and 26, the main body 5140 has a stepped outer contour, which can block different digits in the display window in stages. The specific shape of the main body 5140 is related to how many stages it is used to block different digits in the display window and the difference between the two digits blocked in adjacent stages. Specifically, the number of steps of the main body 5140 is the same as how many stages it is used to block different digits in the display window. For example, when the main body 5140 is used to block the hundreds, tens, and units digits in three stages, the main body 5140 has three steps as shown in Figures 25 and 26 (a first step portion 51400, a second step portion 51401, and a third step portion 51402). When the number of times the inhaler is used reaches a first preset number of times, the first step portion 51400 moves as the second counting unit counts to block the hundreds digit in the display window. When the number of times the inhaler is used reaches a second preset number of times, the second step portion 51401 moves as the second counting unit counts to block the hundreds digit and tens digit together with the first step portion 51400. When the number of times the inhaler is used exceeds the maximum number of times, the third step portion 51402 moves as the second counting unit counts to the display window to block all digits together with the first step portion 51400 and the second step portion 51401.

[0168] Furthermore, the size of each stepped portion of the main body 5140 is related to the difference between the two digits blocked in adjacent stages. For example, if the main body 5140 blocks the hundreds digit when the first preset number of uses is 19 and blocks the tens digit when the second preset number of uses is 9, and the difference between the two digits is 10, then the first stepped portion 51400 of the main body 5140 needs to rotate once with the second counting unit. Accordingly, the size of the first stepped portion 51400 must ensure that the hundreds digit is blocked during this single rotation.

[0169] In one example, the first preset number of uses is configured to be 19 remaining, and the second preset number of uses is configured to be 9 remaining. Exceeding the maximum number of uses corresponds to a count after 0 remaining. That is, when the visual number displayed by the counting component is 19, the main body is blocked on the hundreds digit. When the visual number displayed by the counting component is 9, the main body is blocked on the hundreds digit and the tens digit, and the counting component displays 0. If the counting is triggered again, the main body will block all digits, that is, block the hundreds digit, tens digit, and units digit. Specifically, when the counting component counts from 20 to 19, the first stepped portion 51400 of the main body 5140 moves into the display window and is located at the position corresponding to the hundreds digit. When the counting component counts from 10 to 9, the second stepped portion 51401 of the main body 5140 also moves into the display window, occupying the tens digit to jointly prompt the user with the first stepped portion 51400 that the remaining number of uses is less than 10 doses. As the counting component continues to count down from the number 0, the third step portion 51402 of the main body 5140 moves into the display window, occupying the unit's position to remind the user together with the first step portion 51400 and the second step portion 51401 that it can no longer be used.

[0170] In one embodiment, referring to FIG. 28 in conjunction with FIG. 25 , FIG. 28 is a schematic structural diagram of a counting assembly in an embodiment of the present application including the signal element shown in FIG. 25 . As shown in FIG. 25 and FIG. 28 , the signal element 514 further includes a coupling portion 5141 extending from the body portion 5140. The coupling portion 5141 is radially rotatably engaged with the first counting unit 510, so that the signal element 514 can rotate relative to the first counting unit 510. For example, the coupling portion 5141 is radially engaged with the shaft element 5100 of the first counting unit 510, and the coupling portion 5141 can rotate relative to the shaft element 5100 along with the second counting unit.

[0171] Further, refer to Figure 25, Figure 28 and Figure 29, wherein Figure 29 is shown as the schematic diagram of the relative positional relationship of signal element and actuating mechanism in the embodiment shown in Figure 25 of the present application, as shown in the figure, form a stopper 51410 on the described joint 5141, corresponding, described actuating mechanism 50 comprises a stop pawl 5001, when exceeding the maximum number of times of use of described inhaler, described actuating mechanism 50 makes second counting unit 511 drive described stopper 51410 to rotate to the top of described stop pawl 5001 towards the motion of far-end, to stop the resetting of described actuating mechanism 50.Wherein, the stop pawl 5001 of described actuating mechanism 50 and described driving pawl 5000 are misplaced and are provided with.Particularly, when counting assembly showed numeral 0, also had residual dose in the jar of described inhaler and can be sucked for the user.When the user continued to suck, actuating mechanism 50 drove the first counting unit to rotate and could drive the second counting unit 511 to rotate. For example, the driving pawl 5000 of the actuating mechanism 50 drives the first counting unit to rotate (for example, the number 9 on the first counting unit is located in the display window), and then the single tooth element on the first counting unit engages with the propulsion unit to drive the propulsion unit to rotate, and then the propulsion unit drives the second counting wheel 5110 to rotate. Like this, the signaling element 514 rotates to above the stop pawl 5001 along with the second counting wheel 5110. In the process of the user closing the dust cover 6, the actuating mechanism 50 of the inhaler can move to the proximal end, but the actuating mechanism 50 can only move to the position where its stop pawl 5001 abuts the stop portion 51410. In other words, the stop portion 51410 above the stop pawl 5001 can stop the actuating mechanism 50 from moving further to the proximal end, preventing the actuating mechanism 50 from returning to the proximal state before dispensing the medicine. At this point, the signal element (e.g., the third step 51402 of the signal element) blocks the units digit (e.g., the number 9 in the display window), causing the entire display window to be blocked by the signal element. Furthermore, since the position of the actuator 50 is limited to before it passes over the next tooth, it can drive the tooth with the number 8 located in the display window. Therefore, when the user continues to inhale, the counting assembly will not continue to rotate. In other words, the stop on the signal element prevents the dose counter from counting further when the maximum number of uses of the inhaler is exceeded.

[0172] In one embodiment, the signal element can be a prominent color to more easily attract the user's attention. For example, the signal element can be red, yellow, or the like. In another example, the color of the signal element can be significantly different from the color of other visible parts of the dose counter. For example, if the other visible parts of the dose counter are generally light-colored, the signal element can be a darker color such as black.

[0173] In one embodiment, please refer to Figure 12 and combine with Figure 2. As shown in the figure, the dose counter 5 also includes a counter housing 52, which is used to accommodate the actuating mechanism 50 and the counting assembly 51 so that the dose counter 5 can be assembled on the inhaler. The counter housing 52 has a groove, recess or similar structure for accommodating the actuating mechanism 50 and the counting assembly 51. The actuating mechanism 50 and the counting assembly 51 can be arranged on the counter housing 52 by a fixing structure such as a snap-fit ​​structure or screw lock. The counter housing 52 can be engaged with the main housing 1 to assemble the actuating mechanism 50 and the counting assembly 51 in the counting space 11. The display window described in any of the aforementioned embodiments can be provided on the counter housing 52 so that visual numbers are displayed to the user through the display window.

[0174] Furthermore, as shown in Figure 12, a display element 520 is configured on the display window, and the display element 520 is used to magnify the numbers in the display window. In one example, the display element 520 includes a magnifying portion 5200 and a shielding portion 5201 extending from the magnifying portion 5200 to both sides. The magnifying portion 5200 is located in the middle area of ​​the display window to magnify the numbers in the display window, and the shielding portions 5201 on both sides are respectively located in the upper and lower areas of the display window to block the upper and lower areas. Furthermore, the upper and lower shielding portions 5201 can also be used to connect with the counter housing 52 to fix the display element 520 on the display window. In one example, as shown in Figure 12, the display element 520 is configured as a concave structure having an outer convex surface. The concave structure is recessed toward the outer convex surface to form a flat area and side areas located on both sides of the flat area. The flat area and the outer convex surface form the magnifying portion 5200, and the side areas and the outer convex surface form the shielding portion 5201. Furthermore, the display element 520 can be entirely transparent, with a smooth surface in the planar area and a rough surface in the side areas. This allows the number on the counting component to be displayed to the user through the magnifying portion 5200, while the side areas cannot be displayed to the user due to the rough surface. Of course, it is also possible to configure only the magnifying portion 5200 of the display element 520 as a transparent material, while the shielding portion 5201 is configured as an opaque or translucent material, and this application is not limited to this.

[0175] The counting mode of described dose counter in a specific embodiment is as follows: under described inhaler initial state, it is 120 doses that described first counting unit and described second counting unit cooperate with display numeral 120 indications that the total number of times of use under inhaler initial state.When the user opened the dust cover 6 of described dose counter, the projection 60 of described dust cover 6 discharged described support 3, so that described support 3 can move to the far end, and with the balance of power of force holding unit.Then, when the user was inhaling mouthpiece 10 and breathing in a medicinal solution once, described support 3 (for example the driving rod 30 of described support 3) moved to the far end and drove described driving member 500 to move to the far end.When driving member 500 moved to the far end, driving member 500 drove first count wheel 5101 of first count unit 510 to rotate, and this moment, first count wheel 5101 rotated and numeral 9 was rotated to the correct display position that was offset in described display window. During this process, the single-tooth element 5103 of the first counting unit 510 rotates until it engages with the propulsion unit 512, driving the second counting wheel 5110 to rotate. This causes the second counting wheel 5110 to rotate the number 11 to the correct position within the display window. After the user closes the dust cover 6, the bracket 3 moves toward the proximal end, causing the driving member 500 to move toward the proximal end. As the driving member 500 moves toward the proximal end, it drives the first actuating gear 5102 to rotate the first counting wheel 5101 in the direction opposite to the counting direction. Driven by the propulsion unit, the second counting wheel 5110 also rotates in the direction opposite to the counting direction. This allows the numbers on the first and second counting wheels 5101, 5110, to be displayed in the correct positions within the display window, i.e., 119 is displayed in the correct position within the display window. Wherein, after the first actuating gear 5102 of the first counting unit and the second actuating gear 5111 of the second counting unit rotate in the opposite direction to counting, can correspond to and engage with the first positioning claw 5130 and the second positioning claw 5131, to prevent that counting from going wrong. Further, by as above counting mode, when the numeral shown by counting assembly is 19, the body 5140 of signal element is moved into a display window to block the hundreds place. When the numeral shown by counting assembly is 9, described body 5140 can further move to the position of the tens place in the display window. After the numeral shown by counting assembly is 0, when the user continues to inhale medicine, the first counting unit can drive the second counting unit to continue to rotate when rotating again, and described body 5140 can further move to the position of the units place in the display window, to all block the hundreds place, tens place and units place in the display window. Can attract the user to notice how much dosage also remains in the inhaler by arranging signal element.

[0176] Wherein, in the embodiment that pushing unit is configured as structure shown in Figure 19 and Figure 20, after counting assembly is shown as numeral 0 (also promptly having reached the counting of maximum number of times), when continuing to drive inhaler, signal element 514 moves to display window along with second count wheel 5110 and all blocks hundreds place, tens place and units place in display window.But at this moment, the stop structure 5130 that is provided with on the pushing unit 512 is positioned at the preparatory engagement position, makes the first counting assembly 510 no longer have driving action to the second counting assembly 511, signal element keeps units place, tens place and the hundreds place that blocks on the display window, prevents counting assembly from exceeding the counting of maximum number of times of use and misleading the user.

[0177] Wherein, in the embodiment that signal element is configured as structure as shown in Figure 25, after counting assembly displays digital 0, when the user continues to inhale, signal element 514 rotates to above the stop pawl 5001 along with second count wheel 5110, in the process that the user closes dust cover 6, the actuating mechanism 50 of inhaler can move to the proximal end, but actuating mechanism 50 can only move to the position that its stop pawl 5001 abuts with stop portion 51410. So can ensure that the units place, tens place and hundreds place on the display window are always blocked, prevent the counting assembly from displaying an error and have a harmful effect on the user.

[0178] In summary, after each use of a medication, how to count the number of times a user uses it is a technical problem that needs to be solved urgently. To this end, this application provides a dose counter with a first and second cooperating counting unit, which uses these cooperating units to visually indicate the number of times the inhaler has been used, thereby achieving accurate counting of the number of times the inhaler has been used. A signal element is also provided to alert the user to the remaining dose in the inhaler. Furthermore, a stopper is provided on the signal element to prevent the drive mechanism from continuing to drive the first and second counting units to count after the signal element blocks the units digit, thus preventing the dose counter from incorrectly indicating the number of times the inhaler has been used.

[0179] Based on the description of the above examples, this application provides multiple embodiments, which are as follows:

[0180] 1. A dose counter, suitable for an inhaler, comprising an actuating mechanism, a counting assembly, and a signaling element, wherein the actuating mechanism is configured to move toward a distal end when driven; the counting assembly is configured to count the number of times the inhaler has been used based on the movement of the actuating mechanism toward the distal end, the counting assembly indicating the number of times the inhaler has been used by presenting a visual number in a display window; and the signaling element is connected to the counting assembly and configured to be driven by the counting assembly to be displayed in the display window to prompt a user when the number of times the inhaler has been used reaches a preset number of times.

[0181] 2. According to the dose counter of embodiment 1, the signal element includes a body portion, and when the number of uses of the inhaler reaches a preset number of uses, the body portion moves to the display window to prompt the user.

[0182] 3. According to the dose counter of embodiment 2, the main body has a stepped outer contour to cover different digits in the display window in stages.

[0183] 4. According to the dose counter of embodiment 3, the main body has a first step portion, a second step portion, and a third step portion; when the number of times the inhaler is used reaches a first preset number of times, the first step portion moves as the second counting unit counts to block the hundreds digit in the display window; when the number of times the inhaler is used reaches a second preset number of times, the second step portion moves as the second counting unit counts to block the display window to block the hundreds digit and tens digit together with the first step portion; when the number of times the inhaler is used exceeds a maximum number of times, the third step portion moves as the second counting unit counts into the display window to block all digits together with the first step portion and the second step portion.

[0184] 5. According to the dose counter described in Example 2, the counting assembly includes a first counting unit and a second counting unit, the first counting unit is driven by the actuating mechanism to count a first set of numbers when the actuating mechanism moves toward the distal end; the second counting unit is linked with the first counting unit to be driven to count a second set of numbers when the first counting unit counts a preset number of times; the first counting unit and the second counting unit cooperate to indicate the number of times the inhaler is used with visual numbers; wherein the main body is engaged with the second counting unit to follow the count of the second counting unit to move to the display window.

[0185] 6. According to the dose counter of embodiment 5, the signal element further comprises a coupling portion extending from the main body, the coupling portion being radially rotatably engaged with the first counting unit so that the signal element can rotate relative to the first counting unit.

[0186] 7. The dose counter according to embodiment 6, wherein a stop portion is formed on the engagement portion, and the actuating mechanism includes a stop pawl, and when the maximum number of uses of the inhaler is exceeded, the distal movement of the actuating mechanism causes the stop portion to rotate above the stop pawl to prevent the actuating mechanism from resetting.

[0187] 8. According to the dose counter of embodiment 5, the counting assembly further comprises a propulsion unit engaged with the second counting unit, and when the first counting unit counts a preset number of times, the propulsion unit engages with the propulsion unit to drive the second counting unit to count.

[0188] 9. According to the dose counter described in Example 8, a stop structure is provided on the propulsion unit. When counting exceeds the maximum number of uses, the first counting unit engages with the propulsion unit to push the stop structure to rotate to a preset engagement position to stop the driving action of the first counting unit on the propulsion unit.

[0189] 10. The dose counter according to embodiment 9, wherein when the count of the maximum number of uses is exceeded, the first pushing unit further causes the second pushing unit to count so that the body portion covers all digits in the display window.

[0190] 11. According to the dose counter of embodiment 9, the advancement unit includes a first gear and a second gear in a linkage relationship; wherein, when the first counting unit counts a preset number of times, the first gear is driven by the first counting unit to drive the second gear to rotate, and the second gear is engaged with the second counting unit to cause the second counting unit to count when rotating.

[0191] 12. The dose counter of embodiment 11, wherein the stop structure is configured as a missing tooth portion or a recessed portion on the first gear of the advancement unit.

[0192] 13. According to the dose counter of Example 8, the first counting unit includes a first counting wheel with a first set of numbers marked on its circumferential surface, and the second counting unit includes a second counting wheel with a second set of numbers marked on its circumferential surface and arranged in parallel with the first counting wheel, and when the first counting wheel and the second counting wheel are driven, they rotate to display their respective corresponding numbers in the display window, so as to indicate the number of times the inhaler has been used by the combination of the two sets of numbers.

[0193] 14. The dose counter according to embodiment 13, wherein the first counting unit further comprises a single tooth element rotating following the first counting wheel, and rotating in a contact manner past the advancing unit to cause the second counting wheel to rotate when the first counting unit counts a preset number of times.

[0194] 15. A dose counter suitable for use with an inhaler, the dose counter comprising an actuating mechanism, a counter housing, and:

[0195] an actuating mechanism configured to move toward the distal end when driven;

[0196] a counter housing having a display window;

[0197] a counting assembly housed in the counter housing, for counting the number of times the inhaler is used based on the movement of the actuating mechanism toward the distal end, wherein the counting assembly indicates the number of times the inhaler is used by presenting visual numbers in the display window;

[0198] Wherein, a display element is configured on the display window to magnify the numbers in the display window.

[0199] 16. According to the dose counter described in Example 15, the display element includes a magnifying portion and a shielding portion formed by extending the magnifying portion to both sides, the magnifying portion is located in the middle area of ​​the display window to magnify the numbers in the display window, and the shielding portions on both sides are respectively located in the upper and lower side areas of the display window to shield the upper and lower side areas.

[0200] 17. According to the dose counter described in embodiment 16, the display element is configured as a concave structure with an outer convex surface, and the concave structure is recessed toward the outer convex surface to form a plane area and side areas located on both sides of the plane area, the plane area and the outer convex surface form the magnifying portion, and the side areas and the outer convex surface form the shielding portion.

[0201] 18. The dose counter according to embodiment 17, wherein the display element is configured with a transparent material, the planar area is configured with a smooth surface, and the side area is configured with a rough surface.

[0202] 19. According to the dose counter described in Example 15, the counting assembly includes a first counting unit and a second counting unit, the first counting unit is driven by the actuating mechanism to count a first set of numbers when the actuating mechanism moves toward the distal end; the second counting unit is linked with the first counting unit to be driven to count a second set of numbers when the first counting unit counts a preset number of times; the first counting unit and the second counting unit cooperate to visually indicate the number of times the inhaler is used.

[0203] 20. The dose counter according to embodiment 19, wherein the counting assembly further comprises a propulsion unit engaged with the second counting unit, and when the first counting unit counts a preset number of times, the propulsion unit engages with the propulsion unit to drive the second counting unit to count.

[0204] 21. According to the dose counter of embodiment 20, the advancement unit includes a first gear and a second gear in a linkage relationship; wherein, when the first counting unit counts a preset number of times, the first gear is driven by the first counting unit to drive the second gear to rotate, and the second gear is engaged with the second counting unit to prompt the second counting unit to count when rotating.

[0205] 22. According to the dose counter of embodiment 19 or 21, the first counting unit includes a first counting wheel with a first set of numbers marked on the circumference, and the second counting unit includes a second counting wheel with a second set of numbers marked on the circumference and arranged parallel to the first counting wheel, and when the first counting wheel and the second counting wheel are driven, they rotate to display their respective corresponding numbers in the display window, so as to indicate the number of times the inhaler has been used by the combination of the two sets of numbers.

[0206] 23. The dose counter according to embodiment 22, wherein the first counting unit further comprises a shaft element distributed along a central axis of the first counting wheel, and the second counting wheel is sleeved on the shaft element to be rotatably supported by the shaft element.

[0207] 24. The dose counter according to embodiment 23, wherein the first counting unit further comprises a first actuating gear fixed to the shaft element, the first actuating gear having a plurality of teeth spaced apart in a circumferential direction, the actuating mechanism abutting against one of the teeth and moving toward the distal end to rotate the first counting wheel by one count.

[0208] 25. The dose counter according to embodiment 22, wherein the second counting unit further comprises a second actuating gear coupled to the advancing unit, the second actuating gear having a plurality of teeth spaced apart in a circumferential direction, wherein the advancing unit drives one tooth in the second actuating gear to move so that the second counting wheel rotates one count.

[0209] 26. The dose counter according to embodiment 22, wherein the first counting unit further comprises a single tooth element rotating following the first counting wheel, and when the first counting unit counts a preset number of times, the single tooth element rotates in a contact manner past the advancing unit to cause the second counting wheel to rotate.

[0210] 27. According to the dose counter of embodiment 22, when the actuating mechanism moves toward the distal end so that the counting assembly counts, the corresponding numbers on the first counting wheel are offset from the correct display position in the display window; when the actuating mechanism moves toward the proximal end for reset, it causes the first counting wheel to rotate in the direction opposite to the counting direction, so that the corresponding numbers on the first counting wheel are displayed at the correct position in the display window.

[0211] 28. An inhaler comprising the dose counter of any one of embodiments 1 to 27.

[0212] 29. A breath-actuated inhaler comprising a main housing, a canister, a force retention unit, and a bracket, wherein the distal end of the main housing has a mouthpiece; the canister stores a drug solution and is axially arranged within the main housing; the force retention unit is attached to the main housing and engages with the canister to activate the canister in response to a user's inhalation through the mouthpiece; the bracket is connected to the force retention unit to position the force retention unit; a dose counter as described in any one of Examples 1 to 27 is arranged in the main housing and is used to count the number of times the inhaler is used.

[0213] 30. The inhaler of embodiment 29, wherein the bracket is further connected to the dose counter, the bracket being configured to drive the dose counter to count when the force maintaining unit moves toward the distal end in response to a user's inhalation.

[0214] 31. The inhaler according to embodiment 29, wherein the main housing has a counting space for arranging the dose counter, the counting space is provided with a hole structure, and the bracket has a driving rod that can extend through the hole structure to drive the dose counter to count.

[0215] 32. The inhaler of embodiment 29 wherein the actuation mechanism in the dose counter is formed on the bracket.

[0216] The above embodiments are merely illustrative of the invention and the beneficial effects achieved by this application and are not intended to limit this application. Anyone familiar with the art may modify or alter the above embodiments without departing from the principles and scope of this application. Therefore, all equivalent modifications or alterations accomplished by a person of ordinary skill in the art without departing from the spirit and technical concepts disclosed in this application shall be covered by the claims of this application.

Claims

1. A dose counter, characterized in that: Suitable for use with an inhaler, the dose counter comprises: an actuation mechanism configured to move toward the distal end when driven; The counting assembly comprises a first counting unit and a second counting unit; the first counting unit is driven by the actuating mechanism to count a first set of digits when the actuating mechanism moves toward the distal end, and drives the second counting unit to count a second set of digits when the first counting unit counts a preset number of times, and the first counting unit and the second counting unit cooperate to indicate the number of times the inhaler is used with visual digits.

2. The dose counter according to claim 1, characterized in that The first group of digits is set to one digit, and the second group of digits is set to two digits, so that the first counting unit and the second counting unit cooperate to indicate the number of uses in the inhaler with three digits.

3. The dose counter according to claim 2, characterized in that In the initial state of the inhaler, the first counting unit and the second counting unit cooperate to display the number 120 to indicate that the total number of times the inhaler is used in the initial state is 120.

4. The dose counter according to claim 1, characterized in that The indicated usage count of the inhaler includes at least one of the usage count during testing at the production stage and the usage count after leaving the factory.

5. The dose counter according to claim 4, characterized in that: The first counting unit and the second counting unit cooperate to sequentially display integers from 130 to 120 to indicate the number of times the production phase test is used.

6. The dose counter according to claim 1, characterized in that The counting assembly is used to indicate the number of uses remaining in the inhaler.

7. The dose counter according to claim 1, characterized in that The counting assembly further comprises a propulsion unit engaged with the second counting unit, and the first counting unit is engaged with the propulsion unit when counting a preset number of times so as to drive the second counting unit to count through the propulsion unit.

8. The dose counter according to claim 7, characterized in that The propulsion unit includes a first gear and a second gear in a linkage relationship; wherein, when the first counting unit counts a preset number of times, the first gear is driven by the first counting unit to drive the second gear to rotate, and the second gear is engaged with the second counting unit to prompt the second counting unit to count when rotating.

9. A dose counter according to claim 1, 7 or 8, characterized in that The first counting unit includes a first counting wheel with a first group of numbers marked on the circumference, and the second counting unit includes a second counting wheel with a second group of numbers marked on the circumference and arranged in parallel with the first counting wheel. When the first counting wheel and the second counting wheel are driven, they rotate to present their corresponding numbers in the display window, so as to indicate the number of times the inhaler is used through the combination of the two groups of numbers.

10. The dose counter according to claim 9, characterized in that The first counting unit further comprises an axis element distributed along the central axis of the first counting wheel, and the second counting wheel is sleeved on the axis element so as to be rotatably supported by the axis element.

11. The dose counter according to claim 10, characterized in that The first counting unit further comprises a first actuating gear fixed on the shaft element, which has a plurality of teeth spaced apart in the circumferential direction, and the actuating mechanism moves toward the distal end against one of the teeth to rotate the first counting wheel by one count.

12. The dose counter according to claim 11, characterized in that The first group of numbers marked on the first counting wheel includes ten integer numbers from 0 to 9, and the first actuating gear has 10 teeth corresponding to the ten integer numbers.

13. The dose counter according to claim 9, characterized in that The second counting unit further comprises a second actuating gear combined with the advancing unit and having a plurality of teeth spaced apart in a circumferential direction. The advancing unit drives one tooth in the second actuating gear to move so that the second counting wheel rotates one count.

14. The dose counter of claim 9, wherein: The first counting unit further comprises a single-tooth element rotating along with the first counting wheel. When the first counting unit counts a preset number of times, the single-tooth element rotates through the advancing unit in a contacting manner to cause the second counting wheel to rotate.

15. The dose counter according to claim 14, characterized in that A stop structure is disposed on the first gear of the propulsion unit. When the counting exceeds the maximum number of times, the single-tooth element pushes the first gear to rotate the stop structure to a preset engagement position to stop the driving action of the single-tooth element on the propulsion unit.

16. The dose counter of claim 15, wherein: The stop structure is configured as a tooth-missing portion or a recessed portion on the first gear.

17. The dose counter of claim 9, wherein: When the actuating mechanism moves toward the distal end to make the counting assembly count, the corresponding numbers on the first counting wheel are offset from the correct display position in the display window; when the actuating mechanism moves toward the proximal end to reset, the first counting wheel is caused to rotate in the direction opposite to the counting direction, so that the corresponding numbers on the first counting wheel are displayed at the correct position in the display window.

18. The dose counter of claim 1, wherein: The counting assembly further includes a bottom frame for configuring the first counting unit and the second counting unit, and a first positioning claw corresponding to the first counting unit and a second positioning claw corresponding to the second counting unit are arranged on the bottom frame.

19. The dose counter of claim 1, wherein: The dose counter further comprises a signal element, which comprises a main body. When the number of times the inhaler is used reaches a preset number of times, the main body moves into a display window to prompt the user.

20. The dose counter of claim 19, wherein: The body is coupled to the second counting unit to move to the display window as the second counting unit counts.

21. The dose counter of claim 19, wherein: The main body has a stepped outer contour to shield different digits in the display window in stages.

22. The dose counter of claim 21, wherein: The main body has a first step portion, a second step portion, and a third step portion. When the number of times the inhaler is used reaches a first preset number of times, the first step portion moves to block the hundreds digit in the display window along with the count of the second counting unit. When the number of times the inhaler is used reaches a second preset number of times, the second step portion moves to block the display window along with the count of the second counting unit to block the hundreds digit and the tens digit together with the first step portion. When the number of times the inhaler is used exceeds a maximum number of times, the third step portion moves to the display window along with the count of the second counting unit to block all digits together with the first step portion and the second step portion.

23. The dose counter of claim 19, wherein: The signal element further comprises a joint portion extending from the main body, and the joint portion is rotatably engaged with the first counting unit in a radial direction so that the signal element can rotate relative to the first counting unit.

24. The dose counter of claim 23, wherein: A stop portion is formed on the joint portion, and the actuating mechanism includes a stop claw. When the maximum number of uses of the inhaler is exceeded, the movement of the actuating mechanism toward the distal end causes the second counting unit to drive the stop portion to rotate above the stop claw to prevent the actuating mechanism from being reset.

25. The dose counter of claim 1, wherein: A counter housing is also included for accommodating the actuating mechanism and the counter assembly to assemble the dose counter on the inhaler.

26. The dose counter of claim 25, wherein: A display window is provided on the counter housing, and a display element is disposed on the display window for magnifying the numbers in the display window.

27. The dose counter of claim 25, wherein: The display element includes a magnifying portion and a shielding portion formed by extending the magnifying portion to both sides, the magnifying portion is located in the middle area of ​​the display window to magnify the numbers in the display window, and the shielding portions on both sides are respectively located in the upper and lower side areas of the display window to shield the upper and lower side areas.

28. A dose counter, characterized in that Suitable for use with an inhaler, the dose counter comprises: an actuation mechanism configured to move toward the distal end when driven; A counting component, for counting the number of times the inhaler is used based on the movement of the actuating mechanism toward the distal end, wherein the counting component indicates the number of times the inhaler is used by presenting a visual number in a display window; The signal element is connected to the counting component and is used to be driven by the counting component to be presented in the display window to prompt the user when the number of times the inhaler is used reaches a preset number of times.

29. An inhaler, characterized in that Comprising a dose counter as claimed in any one of claims 1 to 28.

30. A breath-actuated inhaler, characterized in that include: A main housing having a suction port at its distal end; a tank storing a drug solution and axially disposed in the main housing; a force retention unit attached to the main housing and engaged with the canister to activate the canister in response to a user's inhalation through the mouthpiece; a bracket connected to the force holding unit to position the force holding unit; A dose counter according to any one of claims 1 to 28, arranged in the main housing, for counting the number of uses of the inhaler.

31. The inhaler according to claim 30, characterized in that The bracket is also connected to the dose counter, and is used to drive the dose counter to count when the force maintaining unit moves toward the distal end in response to the user's inhalation.

32. The inhaler according to claim 30, characterized in that The main housing has a counting space for arranging the dose counter, the counting space is provided with a hole structure, and the bracket has a driving rod which can extend through the hole structure to drive the dose counter to count.

33. The inhaler according to claim 30, characterized in that An actuation mechanism in the dose counter is formed on the support.

34. The inhaler of claim 30, wherein: The proximal end of the force maintenance unit has an air inlet structure.

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