Dispensing device and drug delivery device

Abstract

The application discloses a dispensing device and a dosing device, the dispensing device comprises a main shell and a jet body, the main shell comprises a chamber for configuring a tank, a limiting space is formed in the chamber; wherein the tank comprises a valve rod for dispensing the solution stored in the tank; the jet body is detachably configured in the limiting space, the jet body is used for the valve rod to extend in when the tank is placed in the chamber, and the jet body is used for jetting the solution dispensed by the valve rod.

Description

Technical Field

[0001] This application relates to the field of dispensing device technology, and in particular to a dispensing device and a drug delivery device. Background Technology

[0002] Dispensing devices can atomize and spray solutions, making them suitable for treating or alleviating respiratory illnesses. For example, metered-dose inhalers use compressed gas to atomize and spray a drug solution, allowing patients to directly inhale the medication for rapid relief or long-term symptom control.

[0003] Generally, a dispensing device typically includes a main housing and a container housed within the main housing. The main housing contains a spray nozzle, and the container is connected to the spray nozzle within the main housing, allowing the solution to be released to the user through the spray nozzle. In the prior art, the spray nozzle is integrally formed within the main housing (or the spray nozzle and the main housing are an integral structure). While this simplifies assembly and manufacturing processes to some extent, it does not take into account the functional characteristics of the main housing and the spray nozzle, and instead brings a series of problems, such as: (1) high material requirements, requiring the discovery of materials that simultaneously meet both performance requirements; (2) high upgrade and maintenance costs, as the integral structure of the main housing and the spray nozzle necessitates the replacement of the entire unit when either part needs repair or replacement; (3) insufficient design flexibility, as the integral structure limits the independent optimization space of the main housing and the spray nozzle, especially in the pharmaceutical field where it is impossible to adjust the spray nozzle design only for different drug formulations or patient needs. Summary of the Invention

[0004] In view of the shortcomings of the above-mentioned related technologies, the purpose of this application is to provide a dispensing device and a drug delivery device to overcome a series of technical problems existing in the above-mentioned related technologies.

[0005] To achieve the above and other related objectives, a first aspect of this application provides a dispensing device, including a main housing and a jet, the main housing including a chamber for arranging a can, the chamber forming a limiting space; wherein the can includes a valve stem for dispensing a solution stored therein; the jet is detachably disposed in the limiting space, the jet being inserted into the valve stem when the can is placed in the chamber to spray the solution dispensed by the valve stem.

[0006] A second aspect of this application provides a drug delivery device, including a dispensing device as provided in any embodiment of the first aspect of this application.

[0007] In summary, the dispensing and drug delivery devices provided in this application replace the spraying parts in related technologies with a spray body that can be detachably configured in the main housing. This allows the main housing and the spray body to be designed or modified as two independent components. For example, different materials can be selected according to the characteristic requirements of each component, and the internal geometry of the spray body can be modified separately to facilitate production and mold adjustment while achieving the purpose of changing the spraying area, shape, or angle. Attached Figure Description

[0008] The specific features involved in this application are shown in the appended claims. The features and advantages of the invention can be better understood by referring to the exemplary embodiments and accompanying drawings described in detail below. A brief description of the drawings is as follows:

[0009] Figure 1 and Figure 2 The images shown are cross-sectional schematic diagrams of the dispensing device in different embodiments of this application.

[0010] Figure 3 and Figure 4 The images shown are cross-sectional views of the assembly and separation of the main housing and the injector in one embodiment of this application.

[0011] Figure 5 The diagram shown is a three-dimensional structural schematic of the jet in one embodiment of this application.

[0012] Figure 6 The diagram shown is a cross-sectional view of the jet in one embodiment of this application.

[0013] Figure 7 The diagram shown is a cross-sectional view of the interaction between the injector and the valve stem in one embodiment of this application.

[0014] Figures 8 to 10 The images shown are schematic diagrams of the front structure of the jet in different embodiments of this application.

[0015] Figure 11 and Figure 12 These are magnified views of the limiting space in different embodiments of this application.

[0016] Figure 13 This is a schematic diagram showing the intermediate state of the ejector entering the limiting space in one embodiment of this application.

[0017] Figure 14 This application is displayed. Figure 5 The diagram shows the three-dimensional structure of the jet from another perspective.

[0018] Figure 15 The diagram shown is a structural schematic of a dispensing device according to another embodiment of this application.

[0019] Figure 16 The diagram shown is a structural schematic of the separation of the main housing and the upper housing in one embodiment of this application.

[0020] Figure 17 and Figure 18 The diagrams show the external and internal structures of a respiratory-actuated inhaler in one embodiment of this application.

[0021] Figure 19 The diagram shown is a structural schematic of the main housing from another perspective in one embodiment of this application.

[0022] Figure 20 The diagram shown is a structural schematic of a force-holding unit in one embodiment of this application.

[0023] Figure 21 The diagram shown is a structural schematic of the diaphragm in one embodiment of this application.

[0024] Figure 22 The diagram shown is a structural schematic of the bracket in one embodiment of this application.

[0025] Figure 23 The diagram shown is a schematic representation of an inhaler in a dormant state in one embodiment of this application.

[0026] Figure 24 Displayed as Figure 23 The diagram shows the force-holding unit in a dormant state.

[0027] Figure 25 The diagram shown is a schematic representation of an inhaler in a ready state in one embodiment of this application.

[0028] Figure 26 This diagram shows the force-holding unit of the inhaler in the activated state.

[0029] Figure 27 and Figure 28 The following are schematic diagrams of the dose counters in different embodiments of this application.

[0030] Figure 29 This application is displayed as being in Figure 27 The illustrated embodiment shows a schematic diagram of the actuator moving to the distal end.

[0031] Figure 30 The diagram shown is a structural schematic of the propulsion unit in one embodiment of this application.

[0032] Figure 31 The diagram shown is a schematic diagram of the split structure of the first counting unit and the second counting unit in one embodiment of this application.

[0033] Figure 32 and Figure 33 The diagrams shown are schematic representations of the structure of the first counting unit in different embodiments.

[0034] Figure 34 The diagram shown is a structural schematic of the propulsion unit in one embodiment of this application.

[0035] Figure 35 This application is displayed as being in Figure 34 The diagram shows the operational state of the stopping structure in the propulsion unit.

[0036] Figure 36 The diagram shown is a schematic representation of the digits displayed by the counting component in one embodiment of this application being offset from the display window.

[0037] Figure 37 This application is displayed as being in Figure 27 The illustrated embodiment shows a schematic diagram of the actuator moving towards the proximal end.

[0038] Figure 38 The diagram shows, in one embodiment of this application, a digit displayed by the counting component correctly displayed in a display window.

[0039] Figure 39 The diagram shown is a schematic representation of the counting component from one perspective in one embodiment of this application.

[0040] Figure 40 and Figure 41 The diagrams shown are schematic representations of the signal elements in different embodiments of this application.

[0041] Figure 42 The diagram shown is a schematic representation of the engagement of a signal element and a second counting wheel in one embodiment of this application.

[0042] Figure 43 This application is shown to include Figure 40 The schematic diagram of the counting component in the embodiment of the signal element shown is a structural diagram.

[0043] Figure 44 This application is displayed as being in Figure 40 A schematic diagram showing the relative positional relationship between the signal element and the actuation mechanism in the illustrated embodiment.

[0044] Figure 45 The diagram shows a box plot of the delivery dose uniformity obtained in an experiment according to this application.

[0045] Figure 46 The figure shown is a graph illustrating the correlation analysis results between spray weight and delivery dose obtained in an experiment of this application.

[0046] Figure 47 The diagram shows a box plot of the fog cloud leading edge velocity obtained in the experiments of this application.

[0047] Figure 48 The MMAD box plots of aerosols generated by different devices are shown.

[0048] Figure 49 The distribution curves of drug deposition at various levels of the respiratory tract are shown.

[0049] Figure 50 A comparative diagram showing the spray area ranking of each split-type embodiment is displayed.

[0050] Figure 51 The graph shows a comparison of the fine particle mass (FPM) values ​​produced by different samples. Detailed Implementation

[0051] The following specific embodiments illustrate the implementation of this application. Those skilled in the art can easily understand the advantages and technical effects of this application from the content disclosed in this specification.

[0052] In the following description, some embodiments may be referenced to the accompanying drawings. It should be understood that other embodiments not shown in the drawings may also be used, and specific structural, component, mechanism, and operational changes may be made without departing from the spirit and scope of this application. The following detailed description should not be considered limiting, and the scope of the embodiments of this application is defined only by the claims published herein. The terminology used herein is for describing particular embodiments only and is not intended to limit the application.

[0053] It should be understood that although the terms first, second, or third, etc., may be used herein to describe various elements or parameters in some embodiments, these elements or parameters should not be limited by these terms. These terms are used only to distinguish one element or parameter from another, and not to define the order, priority, or importance of multiple elements. For example, a first connection portion may be referred to as a second connection portion, and similarly, a second connection portion may be referred to as a first connection portion, without departing from the scope of the various described embodiments.

[0054] Furthermore, as used herein, the singular forms “a,” “an,” and “the” are intended to include the plural forms as well, unless the context indicates otherwise. It should be further understood that the terms “comprising,” “including,” and “including” indicate the presence of the stated features, steps, operations, elements, components, items, kinds, and / or groups, but do not exclude the presence, occurrence, or addition of one or more other features, steps, operations, elements, components, items, kinds, and / or groups. For example, a process, method, system, product, or device that comprises a series of steps or units is not necessarily limited to those steps or units explicitly listed, but may include other steps or units not explicitly listed or inherent to these processes, methods, products, or devices. Additionally, the term “and / or,” which may be used hereinafter, describes the relationship between related objects, indicating that three relationships may exist; for example, A and / or B can represent: A alone, A and B simultaneously, and B alone. Furthermore, the character “ / ”, unless otherwise specified, generally indicates that the preceding and following related objects have an “and / or” relationship. Additionally, in the description of embodiments of this application, “multiple” refers to two or more. Furthermore, the terms “or” and “and / or” as used herein are interpreted as inclusive, or mean either one or any combination thereof. Exceptions to this definition only arise when a combination of elements, functions, steps, or operations is inherently mutually exclusive in some way.

[0055] 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 "on" another element, the element may be directly on or directly extending onto the other element, or intermediate elements may exist. Conversely, when an element is referred to as being "directly on" another element or "directly extending onto" another element, no intermediate elements exist. It will also be understood that when an element is referred to as being "connected" or "attached" to another element, it may be directly connected or attached to the other element, or intermediate elements may exist. Conversely, when an element is referred to as being "directly connected" or "directly attached" to another element, no intermediate elements exist.

[0056] Relative terms such as “below,” “above,” “upper,” “lower,” “horizontal,” or “vertical” may be used herein to describe the relationship between one element, layer, or region and another element, layer, or region illustrated in the figures. It will be understood that these terms are intended to cover different device orientations other than those depicted in the figures. In this application, “vertical,” “horizontal,” and “parallel” are defined as including cases within ±10% of the standard definition. For example, vertical typically refers to an angle of 90° relative to a reference line, but in this application, vertical refers to cases including those 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.”

[0057] The terminology used herein is for the purpose of describing particular embodiments only and is not intended to limit the application. When used herein, the singular forms “a,” “an,” and “the” are intended to include the plural forms as well, unless the context clearly indicates otherwise. It will also be understood that, when used herein, the terms “comprising,” “including,” “containing,” and / or “comprising” designate the presence of the stated features, integers, steps, operations, elements, and / or components, but do not preclude the presence or addition of one or more other features, integers, steps, operations, elements, components, and / or combinations thereof.

[0058] Unless otherwise specified, all terms used herein (including technical and scientific terms) shall have the same meaning as commonly understood by one of ordinary skill in the art to which this application pertains. It will also be understood that terms used herein shall be interpreted as having the meaning consistent with their meaning in the context of this specification and the relevant field, and shall not be interpreted in an idealized or overly formal sense unless expressly so defined herein.

[0059] In embodiments of this application, the end where the ejector is located is defined as the distal end (as shown in the image). Figure 1 The end corresponding to Z2 in the figure), the end away from the ejector is defined as the proximal end (as shown in the figure). Figure 1 (The end corresponding to Z1 in the diagram). In some embodiments, the distal end may also be referred to as the lower end and the proximal end as the upper end. When describing the relative positional relationship, the direction closer to the distal end can be regarded as the lower end and the direction closer to the proximal end can be regarded as the upper end.

[0060] In the embodiments of this application, the axial direction of the dispensing device or drug delivery device refers to the direction of the central axis of the main body, as shown in the figure. Figure 1In the Z1-Z2 direction shown, the plane perpendicular to the central axis is defined as a horizontal plane, and the plane parallel to the central axis is defined as a vertical plane. When describing relative positional relationships, "configured or arranged along or conforming to the axial direction" means that the extension direction of the component is consistent with the axial direction (the term "consistent" includes both coincidence and parallelism with the axial direction), and "configured or arranged along or conforming to the axial direction" means that the opening can be passed through the axis or a line parallel to the axis.

[0061] In the embodiments of this application, the term "user" refers to a user, such as a tester, patient, or subject. Depending on the specific identity of the user, in some embodiments, the user may also be referred to as a tester, patient, or subject.

[0062] In the embodiments of this application, the dispensed or sprayed solution may be released in the form of mist or atomization (also known as soft mist, aerosol, fine particles, or fine droplets).

[0063] The present application will be further described in detail below with reference to the accompanying drawings and specific embodiments. The technical solutions in the embodiments of the present application are clearly and completely described. Obviously, the described embodiments are only a part of the embodiments of the present application, and not all of the embodiments. Based on the embodiments of the present application, all other embodiments and technical effects obtained by those skilled in the art without creative effort should fall within the scope of protection of the present application. The terms "an embodiment," "implementation," or similar wording used throughout this specification mean that a specific feature, structure, or characteristic described together with an implementation is included in at least one embodiment of the present application. Therefore, the appearance of the phrases "in an embodiment," "in an embodiment," and similar wording throughout this specification may (but does not necessarily) refer to the same implementation.

[0064] In view of the series of problems caused by designing the main housing and the spraying part as an integral structure as described in the background art, this application proposes a dispensing device and a drug delivery device. The dispensing device replaces the spraying part in the related art by designing a spraying body that can be detachably configured in the main housing, so that the main housing and the spraying body can be designed or modified separately as two independent components. For example, different materials can be selected according to the characteristic requirements of each, and the internal geometry of the spraying body can be modified separately to achieve the purpose of changing the spraying area, shape, or angle, while facilitating production and mold adjustment.

[0065] In some embodiments of this application, a dispensing device is proposed that can atomize and spray a solution. In some embodiments, the dispensing device can atomize and spray the solution based on a trigger operation, such as manual triggering (e.g., manual pressing), user breathing triggering, or electronic triggering (e.g., an electronic device or component detecting the dispensing device to automatically trigger it when a condition is met). In some embodiments, the solution may contain a pharmaceutical ingredient, which, when atomized by the dispensing device, forms an aerosol (also referred to as a soft mist, aerosol, fine particles, or fine droplets, etc.) that can be inhaled or breathed by the user, thereby achieving the purpose of treating or alleviating the user's illness, such as treating or alleviating respiratory diseases. Of course, the inclusion of a pharmaceutical ingredient in the solution to make the dispensing device suitable for medical purposes is only one example. In other embodiments, the solution may not contain a pharmaceutical ingredient so that the dispensing device can also be used for other purposes. In this embodiment, the solution may be, for example, water, perfume, cosmetic liquid, etc.

[0066] Please see Figure 1 and Figure 2 The diagram shows a cross-sectional view of the dispensing device in different embodiments of this application, such as... Figure 1 and Figure 2 As shown, the dispensing device 1 includes a main housing 10, a jet 11, and a tank 12. The tank 12 is used to store a solution and includes a valve stem 120 for dispensing the solution. The main housing 10 includes a chamber 100 for housing the tank 12, and the jet 11 is disposed in the chamber 100. When the tank 12 is placed in the chamber 100, the jet 11 allows the valve stem 120 of the tank 12 to extend into it for dispensing the solution dispensed by the valve stem 120.

[0067] In one embodiment, the chamber 100 is configured as a receiving space pre-formed on the main housing 10. The chamber 100 may include a receiving port 102 arranged axially for receiving a canister 12, which can be inserted axially into the receiving port 102 to enter the chamber 100 and further extend into the injector 11. Specifically, as Figure 1 As shown, when the can 12 is disposed in the main housing 10, it is disposed in the chamber 100 with the bottom facing the proximal end (in the direction of Z1), or it can be regarded as the can 12 being disposed in the chamber 100 in an inverted manner.

[0068] In one embodiment, the main housing 10 further includes a suction port 103 communicating with the jet 11. The suction port 103 provides an interface for the user, through which the solution sprayed by the jet 11 can be delivered to the user. Further, as... Figure 1As shown, a dust cover 104 is also connected to the main housing 10. The dust cover 104 can rotate relative to the main housing 10 to open or close the suction port 103. For example, the main housing 10 is provided with a connecting pin, and the dust cover 104 has a groove or hole that matches the connecting pin. The connecting pin engages with the groove or hole so that the dust cover 104 can rotate relative to the main housing 10.

[0069] In one embodiment, a counting space 105 may also be formed on the main housing 10. This counting space is used to configure a dose counter to count the dosage used by the dispensing device 1. Figure 1 and Figure 2 In the illustrated embodiment, the counting space 105 is formed by an inward recess of the main housing 10, and is located opposite to the inhalation port 103. The dose counter can be configured as an electronic counter or a mechanical counter. A specific implementation of the dose counter will be described later in embodiments relating to a breathing-driven inhaler based on the dispensing device 1, and will not be repeated here. However, it should be understood that this application does not limit the dose counter.

[0070] In one embodiment, the solution stored in the canister 12 is a multi-dose drug solution, and the canister 12 can quantitatively dispense the drug solution. In some examples, the drug solution includes an active pharmaceutical ingredient and a pharmaceutical composition for therapeutic purposes. The active pharmaceutical ingredient is related to the disease for which the dispensing device 1 is used to treat, and for example, the active pharmaceutical ingredient includes, but is not limited to, anti-inflammatory drugs, β2-adrenergic receptor agonists, anticholinergic drugs, antihistamines, serotonin agonists, and combinations thereof. The pharmaceutical composition includes at least one of a propellant (also referred to as a jetting agent), a solubilizer, and a surfactant. The propellant is used to atomize the drug in the canister 12, and examples of propellants include tetrafluoroethane (HFA134a) and heptafluoropropane (HFA227). Examples of solubilizers include ethanol and glycerin. Examples of surfactants include oleic acid.

[0071] In one embodiment, such as Figure 1 and Figure 2As shown, the tank 12 includes a tank body 121 and a valve stem 120, with the solution stored in the tank body 121. The valve stem 120 includes a dispensing valve and a rod portion. The dispensing valve (also referred to as a metering valve) communicates with the interior of the tank body 121 and includes a metering chamber with a communication port communicating with the interior of the tank body 121. The metering chamber can be filled with a dose of solution. The rod portion is a hollow rod with an inlet at its proximal end allowing solution to enter and a dispensing port at its distal end allowing solution to exit. Specifically, the rod portion is spring-loaded onto the valve. Due to a trigger operation, the rod portion moves relative to the tank body 121 and compresses the spring. When the rod portion moves a preset distance, the inlet of the rod portion enters the metering chamber of the valve. At this time, a dose of solution enters through the inlet of the rod portion and exits through the dispensing port to enter the injector 11. The triggering operation can correspond to the triggering operation received by the aforementioned dispensing device, and can be, for example, manual triggering (e.g., manual pressing), user breathing triggering, electronic triggering (e.g., electronic devices or components detecting the dispensing device to automatically trigger it when conditions are met), etc., with the dispensing device 1 as an example. Figure 2 As shown in the example, the user can manually press the can 12 to trigger the can 12 to dispense the solution.

[0072] In one embodiment, the injector 11 is detachably (or removably or replaceably) disposed within the main housing 10. Detachability means that the main housing 10 and the injector 11 can be assembled together or disassembled as two independent components without causing damage to the components. Figure 3 and Figure 4 (The images shown are cross-sectional views of the assembly and separation of the main housing and the injector in one embodiment of this application.) As shown, the injector 11 can be disposed in the chamber 100 or can leave the chamber 100 to be separated from the main housing 10; further, the injector 11 can leave or enter the chamber 100 via the receiving port 102.

[0073] Specifically, in the usage state of, for example, a dispensing device, it presents as follows: Figure 1 and Figure 2 As shown, the injector 11 and the main housing 10 are assembled together and the tank 12 is placed in the main housing 10. At this time, the valve stem 120 is engaged with the injector 11, so that the solution can be sprayed outward by means of the injector 11.

[0074] Please see Figure 5 The figure shows a three-dimensional structural schematic diagram of the jet body in one embodiment of this application. As shown, the jet body 11 includes a joint portion 110 and a jet portion 111. Figure 6 and Figure 7 , Figure 6 The diagram shown is a cross-sectional view of the jet body in one embodiment of this application. Figure 7 The diagram shown is a cross-sectional view of the assembly of the injector and valve stem in one embodiment of this application. Figure 6 and Figure 7 As shown, the mating portion 110 includes a mating hole 1100 into which the valve stem 120 extends, and the bottom of the mating hole 1100 has a support portion 1101 to support the valve stem 120. Specifically, the valve stem 120 extends into the mating hole 1100 until it is stopped by the support portion 1101, thereby the support portion 1101 restricts and defines the position of the valve stem 120. The spraying portion 111 includes a nozzle 1110 for spraying a solution and a communicating portion 1111 connecting the mating hole 1100 and the nozzle 1110. Specifically, the communicating portion 1111 has a channel 11110 that extends from the bottom of the mating hole 1100 to communicate with the nozzle 1110, as shown in the figure. Figure 7 As shown by the dashed arrow, when the valve stem 120 is blocked by the support part 1101, the solution dispensed by the valve stem 120 can enter the channel 11110 and then be sprayed out through the nozzle 1110.

[0075] In one embodiment, such as Figure 5 and Figure 6 As shown, the joint 110 can be configured to be cylindrical in shape, with the mating hole 1100 forming a through-hole inside the cylinder. The connecting portion 1111 connects to the joint 110 with its channel 11110 conforming to the connecting mating hole 1100. Further, the inner diameter of the channel 11110 is smaller than that of the mating hole 1100 so that when the connecting portion 1111 connects to the joint 110, its top can partially cover the mating hole 1100 to form a support portion 1101 at the bottom of the mating hole 1100. The extending directions of the respective channels of the nozzle 1110 and the connecting portion 1111 are located on two intersecting planes, for example, on two perpendicularly intersecting planes. In one example, as... Figure 5 and Figure 6 As shown, the nozzle 1110 may further protrude from the connecting portion 1111 so that the spray portion 111 appears to be L-shaped. Of course, the nozzle 1110 may also be flush with the connecting portion 1111 so that the spray portion 111 appears to be I-shaped.

[0076] Considering that the ejection of the solution from the tank will generate a certain impact force, in order to prevent the valve stem from displaced under the impact force and thus cause the tank to displace, in one embodiment, such as Figure 6As shown, a locking structure 1102 for fixing the valve stem 120 is disposed on the inner wall of the mating hole 1100. Further, the locking structure 1102 can contact the valve stem 120 through an interference fit, thereby effectively pressing the valve stem 120 to prevent axial or rotational displacement of the valve stem 120, further ensuring the position of the can in the main housing. In one example, the locking structure 1102 is configured as a protruding structure on the inner wall of the mating hole 1100. When the valve stem 120 is located in the mating hole 1100, the protruding structure can press the valve stem 120 to generate a radial pressing force on the valve stem 120. Further, the protruding structure can be shaped as follows: Figure 6 The diagram shows an annular structure surrounding the inner wall of the mating hole 1100. It may also be multiple protrusions or other structures on the inner wall, and this application does not limit this.

[0077] In one embodiment, such as Figure 6 and Figure 7 As shown, the nozzle 1110 includes a spray hole 1112, which is connected to the connecting portion 1111 to form a channel for spraying solution. The nozzle 1110 may further include a guide channel 1113 connected to the spray hole 1112, through which the solution sprayed through the spray hole 1112 is propelled forward.

[0078] The injection hole 1112 is configured to be at least one, and its opening shape can be arbitrarily configured, and can be a regular opening shape or an irregular opening shape. The regular opening shape refers to a shape that conforms to a certain regularity (such as symmetry, side length or angle conforming to a certain regularity, etc.), such as a circle, an ellipse, a regular polygon, etc. The irregular opening shape refers to a shape without obvious regularity, such as an irregular free curve or an irregular polygon, etc.

[0079] In some preferred embodiments, the nozzle 1110 of the jet 11 is not limited to a single-hole design, but is configured with two or more independent jet holes 1112 (not shown). The arrangement of the two or more independent jet holes is configured to adjust the total spray area and spray velocity through the interaction of the fluids ejected from each jet hole. This multi-hole array design is not simply for increasing the flow rate, but for actively controlling the physical properties of the jet plume through a specific arrangement, specifically including the total spray area and spray velocity.

[0080] Specifically, the arrangement of the two or more injection holes is configured such that the fluid jets ejected at high speed from each injection hole interact with each other within a certain distance immediately after leaving the nozzle end face. This interaction manifests as turbulent interference or spatial impact between the fluid jets.

[0081] In one embodiment, the plurality of independent spray holes are arranged in an array, and the spacing between the spray holes is configured such that the fluid jets ejected from adjacent spray holes are entrained or contracted towards the center, so that the total spray area produced by the nozzle is smaller than the spray area produced by a single-hole nozzle with the same flow cross-sectional area. For example, in the implementation of the four-hole design of sample number POC2-SZ07 provided in the subsequent experiment, the nozzle 1110 of the injector 11 is configured with a plurality (e.g., four) of independent spray holes arranged in a close array. The spacing between the spray holes is set within a specific small range, so that when high-pressure liquid is ejected from each hole simultaneously, a low-pressure zone is generated between adjacent high-speed jets, thereby triggering a strong entrainment effect. This entrainment effect causes the jets to not diverge independently, but to attract each other and converge towards the central axis of the spray plume. Experimental data confirm that this fluid interaction makes the total spray area produced by the multi-hole nozzle (approximately 291 mm²) significantly smaller than the spray area produced by a single-hole nozzle with the same flow cross-sectional area (the spray area of ​​the comparative example of sample number 26073B is approximately 490 mm²). This structural feature allows designers to focus the spray range by increasing the number of nozzles, thereby reducing ineffective drug deposition on the oral cavity sidewalls and improving lung penetration efficiency.

[0082] In one embodiment, multiple injection orifices are arranged in a closely adjacent array (e.g., multiple injection orifices are arranged in a closely adjacent array with the orifice spacing configured such that the ejected jets can interact in a spatial region near or behind the nozzle end face). Experimental data show that when the drug is ejected simultaneously from multiple adjacent injection orifices, aerodynamic interference at the edges of adjacent jets generates turbulence. Compared to single-orifice injection, this turbulent interaction generated by multiple orifices can dissipate some of the jet's kinetic energy. This dissipation of kinetic energy significantly reduces the overall velocity of the spray plume. The lower spray velocity (i.e., the formation of a soft mist) can significantly reduce the inertial impaction and deposition of drug droplets in the user's throat, thereby allowing more drug to be carried downstream with the airflow. The lower spray velocity formed by the aforementioned multi-orifice injection structure helps reduce the inertial impaction of droplets in the throat region, thereby increasing the likelihood of drug being transported downstream with the airflow.

[0083] In another embodiment, the arrangement of the plurality of jet holes is further configured to adjust the total spray area. Contrary to the conventional understanding that a larger number of holes results in a larger area, this application achieves non-linear area control through a specific multi-hole layout. For example, in a four-hole jet embodiment, the total spray area formed is actually smaller than that of a single-hole or dual-hole design due to the strong turbulent entrainment between the four jets. This means that by changing the number and relative positions of the holes (e.g., from a horizontal dual-hole layout to a vertical dual-hole layout, or to a triangular three-hole layout), the designer can programmatically preset the spray coverage to precisely adapt to different oral cavity geometries without altering the mold of the main housing 10.

[0084] In one embodiment, the arrangement further includes a converging design. In this configuration, the axes of the multiple jets are not parallel to each other, but rather converge at an angle towards a point or region in front of the jet direction. When the multiple jets collide at the convergence point, the droplets are further refined during the interaction process, forming a jet plume with a low axial velocity, creating a diffuse, low-speed cloud-like jet. This structure is particularly suitable for oral administration or pulmonary drug delivery scenarios requiring extremely high fine particulate matter (FPM).

[0085] In summary, the split-type spray body 11 described above, through its porous structure and fluid interaction mechanism, achieves a finely customized spray pattern compared to the difficulty of balancing atomization fineness and spray speed in integrated single-hole nozzles.

[0086] The drug delivery device and its dispensing device of this application can also deliver drugs to specific drug delivery sites, such as through the mouth and oral cavity. In one embodiment, the nozzle includes a plurality of jet holes arranged in a converging pattern. The plurality of jet holes of the nozzle are configured to cause the fluid jets ejected from each jet hole to collide with each other or to interact with each other in turbulence in space to form a low-speed soft mist.

[0087] In one embodiment, the nozzle 1110 includes a plurality of (e.g., two, three, or four) converging jet holes 1112. This converging arrangement means that the central axes of the jet holes are not parallel to each other, but are inclined inwards relative to the jetting direction, such that the axes of the jet holes intersect or approach each other at a certain distance in front of the nozzle. This converging jet hole structure design aims to utilize the jet impact principle in fluid dynamics. When high-pressure fluid is simultaneously ejected from each jet hole, multiple high-speed fluid jets undergo violent mutual collisions or turbulent interactions in space (i.e., the converging area outside the nozzle).

[0088] In this embodiment, the central axes of the plurality of injection holes are inclined inward relative to the injection direction of the injector, such that the fluid jets intersect at a predetermined distance after leaving the nozzle. This predetermined distance is configured so that fluid impact occurs in the external space of the injector. For example, in another embodiment designed specifically for gentle drug delivery (e.g., the converging orifice design of sample number POC2-SZ08 in the experiment), the central axes of the plurality of injection holes of the nozzle 1110 are not parallel to each other, but are inclined inward at a predetermined angle (e.g., 10° to 45°) relative to the injection direction. This inclination angle, together with the spacing between the injection holes, causes the high-speed fluid jets ejected from each hole to physically intersect in the external space after leaving the nozzle end face (i.e., at a certain distance in front of the nozzle). At this intersection point, the multiple jets collide violently, and a large amount of kinetic energy is dissipated and converted into surface energy of droplet breakup. This external impact mechanism not only avoids the risk of clogging the internal flow channels of the nozzle, but more importantly, it directly generates a suspended soft mist with an extremely low initial velocity (only about 1.7 mm / ms) and an extremely fine particle size (high FPM) outside the nozzle, which greatly reduces the physical impact on the user's oral or throat mucosa.

[0089] This interaction firstly allows the interaction between jets to change the breakup and diffusion state of droplets, thereby helping to form finer spray particles and increase the proportion of fine particles in the overall spray; moreover, due to the mutual cancellation and dissipation of kinetic energy, a jet plume with a relatively low axial velocity is finally formed, creating a low-speed soft mist.

[0090] Therefore, the low-speed and fine mist described in this embodiment is particularly important for oral drug delivery because it can cover the oral mucosa in an extremely gentle manner, avoiding the physical impact and drug dripping caused by traditional single-orifice high-pressure sprays, and facilitating effective coverage and deposition of the drug in the oral mucosa area. Experimental data confirms that, compared to traditional integrated devices, the split-type spray with this converging arrangement of spray orifices significantly optimizes spray comfort and deposition patterns while maintaining high delivery efficiency.

[0091] Please see Figures 8 to 10 The figures shown are schematic diagrams of the front structure of the jet in different embodiments of this application. Figure 8 In the illustrated embodiment, a single injection hole 1112 is configured, and the opening shape of the injection hole 1112 is configured to be circular. Figure 9 In the illustrated embodiment, four injection holes 1112 are arranged in an array, and all of them have a circular opening shape. Figure 10 In the embodiment shown, the injection hole 1112 is configured as a single hole with a triangular opening shape. Of course, Figures 8 to 10For illustrative purposes only, the injection holes 1112 can also be configured as two, three, or more, or as other opening shapes, such as squares or other polygons.

[0092] It should be noted that the design of the shape, number, and arrangement of the nozzles of the jet can achieve different spraying effects, such as different spray areas, shapes, or angles, thereby better adapting to different user groups. This application, for example... Figure 3 and Figure 4 The detachable configuration of the injector 11 and the main housing 10 shown provides the possibility of modifying the internal geometry of the injector 11 individually (including the shape, number, and arrangement of the injection holes), for example... Figures 8 to 10 The diagram illustrates three different internal geometries of the jetting bodies. Since these jetting bodies have the same external geometry (or shape), they can be adapted to the same main housing. A single main housing can be used to form a distribution device with multiple different jetting effects, which facilitates production and mold adjustment.

[0093] This application, for example Figure 3 and Figure 4 The separable configuration of the ejector 11 and the main housing 10 allows for the selection of materials for each based on their respective characteristics. In one embodiment, the main housing 10 is configured to use a first material, and the ejector 11 is configured to use a second material with different properties from the first material. These different properties include variations in the composition, proportions, or brand of the two materials. In some examples, the main housing serves as a crucial support and protective structure, supporting the ejector and providing an interface with the user. In some examples with an additional upper housing, it also needs to connect to the upper housing. Therefore, the first material used for the main housing needs to possess a certain degree of hardness and strength; for example, ABS material. The ejector primarily connects to the tank to receive and eject the solution. To prevent breakage, the second material used for the ejector needs to possess a certain degree of toughness and withstand environmental changes (such as temperature changes) caused by solution ejection; for example, PP material, resin material, metal, or ceramic. Currently, in other examples, the first and second materials may also be other choices, and this application does not limit them. Depending on actual needs, the ejector 11 and the main shell 12 may also be made of materials with the same properties.

[0094] In one embodiment, the second material is configured as a micro / nano resin; and the thermal conductivity of the second material is lower than that of the first material; when the jet is disposed in the main housing, a thermal barrier gap is formed between the outer wall of the jet and the limiting space, and the micro / nano resin material and the thermal barrier gap are configured together to affect the heat transfer characteristics from the main housing to the interior of the jet, thereby helping to form a jetting state with a lower jet plume velocity.

[0095] In a further embodiment, to improve drug delivery efficiency and reduce throat irritation in patients, this application synergistically optimizes the material thermal properties and assembly structure of the jet 11. Specifically, the second material is configured as a nano-resin or a photosensitive resin. Compared to conventional metals or some engineering plastics, this type of resin material has lower thermal conductivity.

[0096] In particular, thanks to the split design of this application, when the injector 11 is disposed in the limiting space 101 of the main housing 10, the outer wall of the injector 11 is not completely and rigidly fitted with the inner wall of the limiting space 101. Instead, a thermal barrier gap is formed by limiting ribs or tolerance fit, and this gap is filled with air. The combination of the low thermal conductivity resin material and the air thermal barrier gap in this embodiment constructs a highly efficient thermal insulation system. During the injection process, the propellant (such as HFA) in the tank 12 undergoes a phase change process when passing through the nozzle, accompanied by heat exchange, resulting in a relatively low temperature environment inside the injector.

[0097] In traditional one-piece designs, heat from the external environment or the user's hands can be rapidly transferred through the casing to the propellant within the flow channel, making it easier for the propellant to form a faster jet state during injection, resulting in a relatively high jet plume velocity. In this embodiment, however, the aforementioned insulation system effectively suppresses heat transfer from the main casing 10 to the solution inside the injector 11.

[0098] As follows Figure 47 As shown in the comparative data in Table 3, the leading edge velocity of the mist in the split-type embodiment (sample number POC2-SZ01) (approximately 1.8 mm / ms) is only 50% of that in the integrated comparative example (sample number 26073B, approximately 3.6 mm / ms). This directly proves that the thermal barrier gap itself cuts off the thermal bridge, significantly reducing the jet kinetic energy. Furthermore, when using micro-nano resin materials (such as sample numbers POC2-SZ02 or POC2-SZ08), combined with a specific flow channel design, the spray velocity can be stably maintained in a lower range, such as the 1.7 mm / ms to 2.8 mm / ms range provided in Table 3.

[0099] Experimental results show that, under the influence of the aforementioned heat transfer characteristics, the propellant ejection behavior exhibits a more moderate trend, thus helping to reduce the initial velocity of the ejection plume. Lower ejection velocities mean that the propellant droplets have less momentum, thereby reducing inertial impaction deposition in the throat (e.g., Figure 49 The APSD data showed that the resin group had significantly reduced laryngeal deposition, thereby increasing the likelihood of drug delivery downstream with the inspiratory flow and into the lungs.

[0100] In another embodiment, the jet is a monolithic part based on the micro / nano resin; the jet orifice of the jet has a flow channel geometry without a draft angle, which is configured to provide uniform fluid shear force to generate a soft mist jet plume. The flow channel geometry without a draft angle refers to a specific geometric shape in which the sidewalls of the jet orifice 1112 and the connecting portion 1111 of the jet 11 are parallel to the flow channel central axis or exhibit a non-constricting or non-expanding shape. This shape is difficult or impossible to achieve in conventional injection molding processes due to the limitations of mold core-pulling and demolding requirements. Specifically, in conventional injection molding processes, in order to smoothly eject the molded part from the mold, a certain inclination angle (usually called a draft angle, for example, 1° to 3°) must be set on the sidewalls along the demolding direction. This results in the internal flow channels of conventional monolithic nozzles often exhibiting an unavoidable slight taper, i.e., the flow channel cross-sectional area gradually changes along the axial direction. Although this geometrical variation caused by process limitations is small, it can cause uneven distribution of the fluid velocity field when high-speed fluid passes through micron-sized nozzles, resulting in shear force dispersion and thus affecting the consistency of atomized droplet size.

[0101] In contrast, the micro / nano resin molding process (such as high-precision 3D printing or additive manufacturing) used in this application embodiment is not limited by the demolding principle. Therefore, the injection hole 1112 of the injector 11 can be constructed as a straight cylinder, rectangle, or other complex shape with a constant cross-section, or as having a specific curvature designed specifically for optimizing fluid dynamics (such as a reverse inverted or complex contraction-expansion nozzle structure), without considering any compromise in the design of the draft angle for demolding. This geometry without a draft angle ensures that the flow channel shape fully serves the fluid dynamics optimization goal, thereby providing uniform and concentrated fluid shear force, promoting the efficient breakup of the liquid into a soft mist with an extremely narrow particle size distribution.

[0102] In this embodiment, the jet 11 is manufactured using micro / nano resin through a high-precision molding process (such as micro / nano 3D printing or precision injection molding). Compared with traditional metal drilling or ordinary injection molding processes, micro / nano resin molding technology can achieve extremely high dimensional accuracy and structural fidelity. In particular, it can form jet holes 1112 with flow channel geometry without draft angle when there is no need to consider the injection molding draft angle.

[0103] This flow channel geometry without draft angle helps improve spray pattern. In traditional injection molding processes, due to limitations in demolding requirements and material shrinkage, the nozzle flow channel often has slight taper variations or rounded edges, which may cause the shear force of the fluid to disperse at the moment of ejection, affecting the uniformity of droplet breakup.

[0104] In this embodiment, the micro-nano resin material, combined with its molding process, ensures the precision of the jet orifice flow channel shape. This precise structural definition enables the fluid to achieve more stable hydrodynamic behavior when passing through the jet orifice, promoting effective droplet breakup and uniform distribution.

[0105] The technical effectiveness of this embodiment has been fully verified by the APSD test data of this application. Please refer to... Figure 48 As shown in Table 4, compared to the conventional one-piece plastic device (the comparative example of sample number 26073B has a median mass aerodynamic diameter (MMAD) of approximately 1.3-1.5 µm), the aerosol produced by the split-type embodiment (POC2-SZ01) made with micro-nano resin exhibits a significantly smaller MMAD and a more concentrated numerical distribution. This indicates that the flow channel geometry without draft angle effectively promotes the fine fragmentation of droplets. Simultaneously, the resin group in this embodiment exhibits the narrowest geometric standard deviation (GSD), demonstrating a high degree of consistency in spray particle size. In other words, the result of this embodiment is that the nozzle can produce a soft mist morphology with a narrower particle size distribution (lower GSD) and a smaller median diameter (lower MMAD). This soft mist morphology, with its fine, uniform, and diffuse characteristics, greatly improves the aerodynamic performance of the aerosol, making it easier for patients to inhale.

[0106] In another embodiment, the second material is configured as a photosensitive resin or a micro / nano resin; the jet is a monolithic part based on the second material, and the nozzle channel of the jet has a microscopic surface structure defined by the second material, which is configured to regulate the flow state of the solution as it flows through the nozzle channel, thereby facilitating the formation of a low-velocity soft mist jet. In this embodiment, the properties of the photosensitive resin or micro / nano resin material used in this application allow the jet 11 to be manufactured as a monolithic part with a complex internal geometry. This means that the nozzle channel of the jet 11 (including the connecting portion 1111 and the jet hole 1112) can be designed and manufactured with specific microscopic surface structures, thereby reducing the reliance on traditional processing limitations such as draft angles or drill paths in the design.

[0107] The microstructures may include precisely designed flow channel chamfers, minute flow-guiding textures, or specific variations in flow channel curvature. These microstructures are configured to modulate the flow state of the solution as it passes through the nozzle, thereby improving fluid behavior within the flow channel and reducing the generation of unfavorable flow conditions. Through the effects of these microstructures, the fluid exits the nozzle exhibits a more uniform jet pattern, thus improving the overall stability of the spray plume.

[0108] Experimental data show that the spray plume with an optimized, one-piece molded microstructure, such as the embodiment with sample number POC2-SZ08, has a cloud leading edge velocity reduced to approximately 1.7 mm / ms. This is not only significantly lower than the one-piece comparative example (approximately 3.6 mm / ms) but also the lowest among all test groups. This indicates that the microstructure plays a crucial role in the dissipation and rectification of fluid kinetic energy. While maintaining a low flow rate, the fine particle mass (FPM) of this structure reaches approximately 51.2 µg, superior to the device in the comparative example with sample number 26073B. Therefore, the experimental data support the view that the spray plume formed by this one-piece molded micro / nano resin microstructure, while producing the same atomization fineness, exhibits a lower cloud leading edge velocity characteristic while maintaining atomization performance. This low-velocity soft mist characteristic not only improves patient inhalation comfort (reducing the cooling effect and coughing sensation) but also helps improve drug deposition in the lung region, demonstrating the technological advantages brought about by the combination of material properties and microstructure design.

[0109] Please continue reading. Figure 3 and Figure 4 The injector 11 is further detachably (or removably or replaceably) disposed within a limiting space 101 formed within the chamber 100, the limiting space 101 being adapted to the shape of the injector 11. Please refer to... Figure 11 and Figure 12 The images shown are magnified views of the limiting space in different embodiments of this application. The limiting space 101 includes a first opening 1010 and a second opening 1011. The first opening 1010 allows the injector 11 to enter or leave the limiting space 101, and the second opening 1011 provides an outlet for the injector's sprayed solution when the injector 11 is placed in the limiting space 101. It should be noted that, as Figure 11 and Figure 12 The limiting space 101 shown includes a first opening 1010 and a second opening 1011, which is only one example. In other examples, it may be configured as a limiting space with only one opening for the ejector to leave or enter the limiting space, and its nozzle is located at the opening when the ejector enters the limiting space so that the opening provides an outlet for the ejected solution.

[0110] In example Figures 1 to 4In the embodiment where the chamber 100 shown includes a receiving port 102, the first opening 1010 may be provided corresponding to the receiving port 102, so that the ejector 11 can be disposed in the limiting space 101 through the receiving port 102 and the first opening 101, or leave the main housing 10 through the first opening 101 and the receiving port 102.

[0111] In one embodiment, when the jet 11 is disposed in the limiting space 101 of the main housing 10, a thermal barrier gap is formed between the outer wall of the jet 11 and the inner wall of the limiting space 101. In this embodiment, the present application utilizes the structural characteristics of a split design to adjust the spray performance at the level of heat transfer characteristics. Specifically, when the jet 11 is inserted and disposed in the limiting space 101 of the main housing 10, the outer wall of the jet 11 and the inner wall of the limiting space 101 do not form a completely tight fit, but rather retain a preset thermal barrier gap (not shown in the figure, which can be understood as a small gap between the two walls). The thermal barrier gap is filled with air. Air typically has lower thermal conductivity than common solid materials (such as ABS or PP). Therefore, this gap forms a heat insulation structure between the jet 11 and the external environment (including the main housing 10 and the heat from the user's hand holding the main housing) to reduce heat transfer.

[0112] During drug delivery, when the propellant solution (typically containing volatile propellants such as HFA) in canister 12 is released into the injector 11, the propellant undergoes vaporization accompanied by heat exchange, creating a relatively low-temperature environment inside the injector. In conventional one-piece designs, external heat rapidly replenishes the propellant, making it easier for it to form a faster ejection state during injection, resulting in a relatively high ejection plume velocity. However, in this embodiment, the presence of a thermal barrier gap reduces the heat transfer rate from the main casing 10 to the injector 11, thus affecting the heat exchange behavior of the propellant during injection.

[0113] Please see the following. Figure 47 And the data provided in Table 3. In the comparative test with strict control of variables, two sets of samples with exactly the same material (both conventional plastic polypropylene / PP) and similar nozzle geometry parameters (both standard single orifices) were specifically selected for comparison: one set was a comparative example using a traditional integrated structure (sample number 26073B), and the other set was an example using the split structure of this application (sample number POC2-SZ01). Experimental data showed that the leading edge velocity of the mist in the comparative example remained at a relatively high level of about 3.6 mm / ms; while the spray velocity of the split example underwent a qualitative change, significantly decreasing to about 1.8 mm / ms, a reduction of up to 50%.

[0114] Since the two groups of samples showed no significant differences in material thermal properties and flow channel geometry, the thermal barrier gap formed between the outer wall of the injector 11 and the inner wall of the limiting space 101 successfully cut off the thermal bridge, inhibiting the explosive vaporization of the propellant, thereby directly promoting the formation of low-velocity soft mist at the physical structure level. Experimental results show that under the above structural conditions, the jet plume velocity exhibits a lower variation trend, which helps to improve the comfort of the drug delivery process and improve the deposition of drugs in the oropharyngeal region.

[0115] The jet body 11 is configured as follows Figure 5 and Figure 6 Taking the example of including the joint 110 and the spray section 111, when the spray body 11 is disposed in the limiting space 101, its spray section 111 corresponds to the second opening 1011. Furthermore, in, for example... Figures 1 to 4 In an embodiment where the main housing 10 also includes a suction port 103, a second opening 1011 is also provided corresponding to the suction port 103, so that when the jet body 11 is disposed in the limiting space 101, the solution it sprays can be released to the user through the suction port 103.

[0116] In one embodiment, the first opening 1010 and the second opening 1011 are respectively formed on two intersecting planes to adapt the jet 111 to a structure where the extension directions of the respective channels of the nozzle 1110 and the connecting portion 1111 are located on the two intersecting planes, as described above. Further, the first opening 1010 and the second opening 1011 may be shaped as follows: Figure 11 and Figure 12 The diagram shows two perpendicularly intersecting planes.

[0117] In one embodiment, such as Figure 12 As shown, the limiting space 101 also includes a clearance passage 1012 extending from the first opening 1010 to the second opening 1011, combined with Figures 4 to 6 As shown, the clearance passage 1012 allows the nozzle 1110 of the injector 11 to compliantly pass through when the injector 11 enters or leaves the confined space 101. Figures 4 to 6 Taking the jet body 11 shown as an example, the nozzle 1110 protrudes relatively. When the jet body 11 enters the limiting space 101 from the first opening 1010, it can reach the second opening 1011 through the avoidance channel 1012. Figures 4 to 6 as well as Figure 12 The structure shown is only one example. In other examples where the first opening 1010 or the limiting space 101 is insufficient to completely surround the jet 11, a clearance channel can be provided for the jet to pass through. Of course, the clearance channel can be set according to the actual location of the obstruction, and is not necessarily as shown. Figure 12The configuration shown extends from the first opening 1010 to the second opening 1011. It should be noted that in some embodiments, the first opening and the limiting space are sufficient for the ejector to completely enter or exit, and the clearance passage can be omitted, for example... Figure 11 The example shown omits the clearance passage, but is adapted to the shape of the ejector to enter from the first opening 1010 and be positioned in the confined space 101.

[0118] In one embodiment, such as Figure 12 As shown, the bottom of the limiting space 101 extends towards the second opening 1011 to form a support 1013 for carrying the ejector. Further, the support 1013 is used to carry the nozzle of the ejector, combined with... Figure 3 As shown, the injector 11 is placed in the limiting space 101, and the support 1013 can support the nozzle protruding from the limiting space in the injector, thus ensuring the stability of the injector 11.

[0119] In one embodiment, such as Figure 5 and Figure 12 As shown, a first limiting mechanism 112 is disposed on the jet 11, and a first engaging mechanism 1014 is disposed within the limiting space 101 to engage with the first limiting mechanism 112 to restrict the movement of the jet 11 on the horizontal plane. Please refer to [link / reference]. Figure 13 The image shows a schematic diagram of the intermediate state of the ejector entering the limiting space in one embodiment of this application, as shown in the figure. Figure 13 As shown, when the jet 11 enters the limiting space 101, the first limiting mechanism 112 contacts the first cooperating mechanism 1014, and the first cooperating mechanism 1014 can block the movement of the first limiting mechanism 112 on the horizontal plane.

[0120] Please see Figure 14 This application is displayed as such. Figure 5 The diagram shows the three-dimensional structure of the jet from another perspective, combined with... Figure 5 As shown, the first limiting mechanism 112 is configured to include a first limiting post 1121, a second limiting post 1122, and a limiting ring 1120 protruding from the circumferential surface of the jet 11. The first limiting post 1121 and the second limiting post 1122 are elongated strips extending axially. The limiting ring 1120 is arranged to surround and protrude from the circumferential surface of the jet 11, and can be connected between the first limiting post 1121 and the second limiting post 1122 so that the first limiting post 1121, the second limiting post 1122, and the limiting ring 1120 form a single unit; in another example, the limiting ring 1120 may not be connected to either the first limiting post 1121 or the second limiting post 1122. Correspondingly, as... Figure 12 and Figure 13As shown, the first engagement mechanism 1014 is configured to include two baffles for blocking the first limiting post 1121 and the second limiting post 1122, respectively. When the ejector 11 is positioned in the limiting space 101, the two baffles abut against the first limiting post 1121 and the second limiting post 1122, respectively, and the limiting ring 1120 abuts against the inner wall of the limiting space 101, thereby restricting the movement of the ejector 11 on the horizontal plane. Further, the first limiting mechanism 112 may also include a third limiting post 1123, which is evenly distributed between the first and second limiting posts. When the ejector 11 is positioned in the limiting space 101, the third limiting post 1123 abuts against the inner wall of the limiting space 101.

[0121] In one embodiment, the first limiting mechanism 112 can fit against the limiting space 101 by means of interference fit, for example... Figure 5 and Figure 14 In the embodiment shown, the surfaces of the first limiting post 1121 and the second limiting post 1122 that are in contact with the limiting space 101 each have a protruding structure. When the jet 11 is located in the limiting space 101, the protruding structures of the first limiting post 1121 and the second limiting post 1122 can generate radial pressure with the inner wall of the limiting space 101 to ensure the stability of the jet's position.

[0122] It should be noted that the above is merely one structural example of the first limiting mechanism 112 and the first mating mechanism 1014, and this application does not impose any limitations on them. For example, the first limiting mechanism 112 may only include a limiting ring. When the injector 11 is placed in the limiting space 101, the two ends of the limiting ring can respectively abut two baffles, thereby also limiting the movement of the injector 11 on the horizontal plane. Alternatively, the first limiting mechanism 112 may only include three limiting posts or be configured as a limiting block structure, etc. Or, the first limiting post and the second limiting post in the first limiting mechanism 112 may be removed and replaced with a protrusion formed at the bottom of the injector 11. The first mating mechanism 1014 is configured as a baffle at the bottom of the limiting space 101 to contact the protrusion and hinder its movement. Those skilled in the art can form various forms of first limiting mechanisms and corresponding first mating mechanisms based on the ideas provided in this application, as long as they can hinder or limit the movement of the injector on the horizontal plane.

[0123] In one embodiment, such as Figure 5 and Figure 14 As shown, the jet 11 is also equipped with a second limiting mechanism 113, and a second mating mechanism (not shown) is arranged within the limiting space to cooperate with the second limiting mechanism 113 to restrict the axial movement of the jet 11. For example, the second limiting mechanism 113 and the second mating mechanism can adopt any kind of mating method such as snap-fit, engagement, interference fit, magnetic attraction, etc. In one example, it is presented as follows: Figure 14As shown, the second limiting mechanism 113 is configured as an oblique protrusion, and the second mating mechanism can be configured as an oblique groove adapted to the oblique protrusion formed on the inner wall of the limiting space. When the injector 11 is placed in the limiting space, the second limiting mechanism 113 enters the oblique groove and hooks into it in a manner similar to a hook, thus preventing it from easily falling off. However, when external force is involved, the second limiting mechanism 113 is allowed to leave the oblique groove to ensure the separable configuration of the injector 11. It should also be noted that when the second limiting mechanism 113 and the second mating mechanism are engaged, the user can feel the contact or hear the engagement sound, thus indicating to the user that the injector 11 has been placed in place.

[0124] In such Figure 14 In the embodiment shown, the structure of the second limiting mechanism 113 and its position on the third limiting post 1123 are only one example. The second limiting mechanism 113 may also be set in other positions or configured with other structures, as long as it can limit the axial movement of the ejector.

[0125] Please see Figure 15 The figure shows a schematic diagram of the dispensing device in another embodiment of this application. As shown, the dispensing device 1 may further include an upper housing 13, which covers the main housing 10 to enclose the can inside the dispensing device 1. Furthermore, when the upper housing 13 covers the main housing 10 and encloses the can inside the dispensing device 1, the engagement between the can and the injector can also limit and determine the position of the injector. Specifically, when the can is axially positioned in the main housing 10, it can limit the axial position of the injector, preventing the injector from separating during use.

[0126] In one embodiment, the upper housing 10 may be further configured with a triggering mechanism to trigger the can's activation. The triggering mechanism may be triggered by manual, breathing, or other interactive actions, or it may be triggered by electronic control. This application does not limit this.

[0127] Please see Figure 16 The figure shows a schematic diagram of the structure of the main housing and the upper housing separated in one embodiment of this application. As shown, the upper housing 13 is provided with a first engaging structure 130, and the main housing 10 is provided with a second engaging structure 106 to engage with the first engaging structure 130 to position the upper housing 13 when the upper housing 13 is attached to the main housing 10. Further, the engaging method of the first engaging structure 130 and the second engaging structure 106 is axial engagement to restrict the axial movement of the upper housing 13 relative to the main housing 10. Specifically, the first engaging structure 130 and the second engaging structure 106 can, for example, use a combination of a slot and a protrusion to... Figure 16As shown in the example, the first engaging structure 130 is configured as a protrusion inside the upper housing 13, and the second engaging structure 106 is configured as a locking space formed by being recessed into the outer peripheral surface of the main housing 10. The first engaging structure 130 enters the locking space and is engaged in the locking space.

[0128] Furthermore, the upper housing 13 is provided with a first guide structure 131, and the main housing 10 is provided with a second guide structure 107. The first guide structure 131 and the second guide structure 107 cooperate to guide the upper housing 13 to attach to the main housing 10. For example, the second guide structure 107 can be configured as a guide rail, and the first guide structure 131 can be configured as a column. The first guide structure 131 enters the second guide structure 107 to attach to the main housing 10 along the track direction of the second guide structure 107.

[0129] In summary, the present application proposes a dispensing device that replaces the spraying part in related technologies by designing a spraying body that can be detachably configured in the main housing. This allows the main housing and the spraying body to be designed or modified separately as two independent components, which is beneficial for improving spraying performance and facilitating production and mold adjustment.

[0130] In some embodiments, this application also proposes a drug delivery device capable of atomizing a drug solution so that the drug can be released through a soft mist or particles, thereby achieving the purpose of treating or alleviating a user's disease. Furthermore, the drug delivery device can atomize the drug solution based on a triggering operation, for example, this triggering operation can be manual triggering (e.g., manual pressing), user breathing triggering, electronic triggering (e.g., electronic devices or components detecting the dispensing device to automatically trigger when conditions are met), etc.

[0131] In one embodiment, the drug delivery device includes a dispensing device configured as follows: Figures 1 to 16 For details regarding the structures described in any of the embodiments related to this description, please refer to the description of the structures described in the embodiments. Figures 1 to 16 The description of that will not be repeated here.

[0132] In one embodiment, the drug delivery device is configured as an inhaler. In some examples, the inhaler may be a manually triggered inhaler, such as... Figure 1 The dispensing device shown can be configured as a manually triggered inhaler. The solution stored in canister 12 is configured as a medicinal solution. The user can manually press canister 12 to trigger the dispensing of the medicinal solution for inhalation. Of course, in other examples, the inhaler can be configured as a corresponding type of inhaler depending on the actual triggering operation used, and this application does not limit this.

[0133] In one embodiment, the inhaler may be configured as a respiratory-actuated inhaler, which is configured to initiate a drug dispensing in response to a user's inhalation, wherein the dispensed drug is delivered into the user's respiratory tract and lungs via a soft mist or particles, thereby achieving a therapeutic or remission purpose.

[0134] In subsequent embodiments of the respiratory-actuated inhaler in this application, the number of times the inhaler is used can refer to either the remaining number of uses or the number of times the inhaler has already been used. To facilitate differentiation between these two examples of the number of uses in subsequent embodiments, in examples where the number of uses specifically refers to the remaining number of uses, it will be referred to as the remaining number of uses or the number of unused uses; in examples where the number of uses specifically refers to the number of times it has already been used, it will be referred to as the number of used uses. The amount of solution dispensed per use of the inhaler corresponds to one dose; in other words, counting the number of uses of the inhaler is equivalent to counting the dose of the inhaler.

[0135] In subsequent embodiments of the respiratory-actuated inhaler in this application, the indicated number of uses of the inhaler may include at least one of the number of uses during production phase testing and the number of uses after leaving the factory. For example, the indicated number of uses may include the number of uses during production phase testing; that is, two counting units working together can visually indicate the number of uses of the inhaler during production phase testing, thus facilitating user monitoring of the testing process. Alternatively, the indicated number of uses may include the number of uses after leaving the factory; that is, two counting units working together can visually indicate the number of uses of the inhaler after leaving the factory. The number of uses after leaving the factory generally corresponds to actual use, thus allowing users to understand the inhaler's usage status in real time. This enables users to replenish inhalers promptly and avoids misuse of inhalers after they have been depleted, which could delay the user's treatment. Furthermore, the indicated number of uses may include both the number of uses during production phase testing and the number of uses after leaving the factory, thus facilitating both user monitoring of the testing process and real-time understanding of the inhaler's usage status.

[0136] In subsequent embodiments of the respiratory-actuated inhaler in this application, the initial state refers to the state of the inhaler when it leaves the factory; the dormant state refers to the state of the inhaler when it is placed aside or stored, for example... Figure 18In the state presented, the inhaler's dust cover 104 is closed, and the force-holding unit 4 in the inhaler is maintained at the reachable proximal limit position. Therefore, in some embodiments, the state of the structure or unit of the inhaler in its dormant state is also referred to as the proximal state. In some embodiments, the ready state refers to the state in which the inhaler is triggered from the dormant state to wait to be activated for drug dispensing, for example... Figure 17 The image shows the state when the dust cover is open. In some embodiments, the activation state refers to the state presented in response to the user's inhalation and medication dispensing. In some embodiments, the reset state refers to the process of returning the inhaler to a dormant state after dispensing, for example, by... Figure 17 The dust cover that has been opened rotates to Figure 18 The process of closing the state.

[0137] Please see Figure 17 and Figure 18 The figures show schematic diagrams of the external and internal structures of a respiratory-actuated inhaler in one embodiment of this application. As shown, in an embodiment where the drug delivery device is configured as a respiratory-actuated inhaler, in addition to the dispensing device 1, a force-holding unit 4 and a support 3 connected to the force-holding unit 4 to position the force-holding unit 4 may also be included. The dispensing device 1 is configured to include a main housing, a canister, and a jet, specifically as follows... Figures 1 to 16 For the structures described in any of the embodiments related to the description, please refer to the description of the structures described in the embodiments. Figures 1 to 16 The description of that will not be repeated here.

[0138] like Figure 18 As shown, the force-holding unit 4 is attached to the main housing 10 and engages with the can 12 to activate the can 12 in response to inhalation by the user through the suction port 103. Specifically, the force-holding unit 4 can apply a force toward the distal end to the can 12 to activate it when the user inhales. Specifically, after being subjected to force, the can 12 moves toward the distal end, thereby spraying the drug solution in a mist from the valve stem of the can 12.

[0139] In one embodiment, please refer to Figure 18 and Figure 20 , Figure 20The diagram shown illustrates the structure of a force-holding unit 4 in one embodiment of this application. The force-holding unit 4 includes an upper housing 40, with an air inlet structure 48 disposed near its proximal end. The air inlet structure 48 and the inhalation port 103 form a gas flow path, allowing the force-holding unit 4 to activate the canister 12 in response to the user's inhalation. Specifically, the force-holding unit 4 is attached to the main housing 10 via the upper housing 40 and is located near the proximal end of the main housing 10. For example, the upper housing 40 receives the portion of the canister 12 protruding from the main housing 10 and is connected to the main housing 10 via a threaded connection or a snap-fit. The upper housing 40 and the main housing 10 together constitute the outer shell of the inhaler.

[0140] It should be noted that in embodiments where the dispensing device includes an upper housing, the upper housing corresponds to the upper housing 40 of the force holding unit. The structure of the upper housing 40 of the force holding unit in some embodiments can be referred to as follows: Figures 1 to 16 The relevant structure of the upper housing of the distribution device is described in detail here.

[0141] When a user inhales through the inhaler, air enters the inhaler through the air inlet structure. The force holding unit also includes a breathing actuation mechanism housed in the upper housing. Airflow entering the inhaler can enter the breathing actuation mechanism, thereby causing the breathing actuation mechanism to activate the canister.

[0142] In one embodiment, such as Figure 20 As shown, the mechanism for respiratory actuation may include a compression spring 41, a valve assembly (not identified), a retaining ring 45, a diaphragm 46, and a lower cover 47. The compression spring 41, valve assembly, retaining ring 45, diaphragm 46, and lower cover 47 are mounted within the upper housing 40.

[0143] like Figure 20 As shown, the valve assembly includes a valve housing 42, a valve 43, and a valve spring 44. Further, the valve 43 includes a valve blade 430 and a valve seal 431. The valve 43 is rotatably mounted on the valve housing 42, for example, via a connecting pin (not shown) mounted on the valve housing 42. The valve spring 44 is disposed between the valve housing 42 and the diaphragm 46. The valve 43 is biased onto the diaphragm 46 via the valve spring 44, so that the valve seal 431 seals the diaphragm 46 in this biased position. When a user inhales through the inlet, air enters the air intake structure and flows towards the inlet. The airflow exerts a torsional force on the valve blade 430. When the torsional force generated by the airflow is large enough, it causes the valve 43 to rotate.

[0144] In one embodiment, please refer to Figure 20 and Figure 21 , Figure 21 The diagram shown illustrates the structure of the diaphragm in one embodiment of this application. As shown, the diaphragm 46 includes a rigid disc 460 and a flexible skirt 461. The rigid disc 460 is connected to the valve housing 42, and the flexible skirt 461 is connected to the rigid disc 460 and sandwiched between the fixing ring 45 and the lower cover 47. In one embodiment, the rigid disc 460 is made of a rigid material, i.e., it 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, which can undergo deformation such as elongation under stress. 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 (e.g., double injection molding), first using a rigid material to injection mold the rigid disk 460, and then using a flexible material to injection mold the flexible skirt 461 onto the rigid disk 460, thereby making the rigid disk 460 and the flexible skirt 461 an integral structure.

[0145] In one embodiment, the rigid disc 460 includes a valve port. To facilitate differentiation between the valve port on the rigid disc 460 and the valve port on the flexible skirt 461, in subsequent embodiments, the valve port on the rigid disc 460 is referred to as a first valve port 4600. The first valve port 4600 is located in the central region of the rigid disc 460, and when sealed by the valve 43, a sealing cavity 7 is formed between the diaphragm 46 and the lower cover 47. Furthermore, the rigid disc 460 also includes a baffle 4601. The baffle 4601 prevents air from flowing between the diaphragm 46 and the valve sealing portion 431.

[0146] In one embodiment, the rigid disk 460 further includes a boss 4603 disposed at the center of the rigid disk 460 and an outer wall 4604 disposed on the outer side of 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 be further configured to have uneven regions, and the valve housing 42 is coupled to the outer wall 4604 and engages with the uneven regions of the outer surface of the outer wall 4604. To facilitate the positioning of the diaphragm 46, the rigid disk 460 may further include a positioning member 4602. The positioning member 4602 can engage with the valve housing 42 so that the diaphragm 46 is positioned at the engaged position of the valve housing 42.

[0147] like Figure 20As shown, the flexible skirt 461 is disposed between the fixing ring 45 and the lower cover 47 and connected to the rigid disc 460. When the fixing ring 45 moves toward the distal end, the flexible skirt 461 is deformed by the fixing ring 45 (for example, from a wrinkled state to an unfolded state), which can increase the volume of the sealing cavity 7 so that the cavity is under negative pressure when sealed, thereby increasing the sealing performance between the diaphragm 46 and the valve sealing part 431.

[0148] In one embodiment, such as Figure 20 and Figure 21 As shown, 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 the recessed area of ​​the lower cover 47. The second valve hole 4612 is formed on the flexible skirt 461 and communicates with the first valve hole 4600.

[0149] Please continue reading. Figure 22 and combined Figure 18 , Figure 22 The diagram shows a schematic of the support structure in one embodiment of this application. As shown, the support 3 in the inhaler is used to connect to the force-holding unit 4 to position the force-holding unit 4, and can also be used to transmit the force between the other components connected to it and the force-holding unit 4. Specifically, the support 3 can be sleeved on the canister 12 and connected to the lower cover 47.

[0150] In one embodiment, the support 3 includes a support body 32 and a support rod 31. The support body 32 is generally ring-shaped and can be fitted onto the tank. The support rod 31 is disposed on opposite sides of the distal end of the support body 32. When the dust cover 104 is closed, the support rod 31 is supported by the dust cover 104 to be held in a proximal state, thereby positioning the force holding unit 4 under the action of the support body 32 to keep the force holding unit in a proximal state. Further, a reinforcing portion is provided on the support rod 31 in contact with the dust cover 104 to enhance the rigidity of the support rod 31. It should be noted that the force holding unit 4 being held in a proximal state means that the lower cover 47 and the fixing ring 45 in the force holding unit 4 are in a proximal state, the compression spring 41 is in a compressed state, and the valve 43 seals the diaphragm 46. Although Figure 8 In the illustrated embodiment, there are two support rods 31, but in other embodiments, there may be more than two support rods 31.

[0151] The following combination Figures 23 to 26The different states of the inhaler, and the interactions between the force-holding unit, the support, and the canister in each state, are explained. Figure 23 This is a schematic diagram showing the inhaler in a dormant state in one embodiment of this application. Figure 24 Displayed as Figure 23 The diagram shows the force-maintaining unit in a dormant state. Figure 25 This is a schematic diagram showing the inhaler in a ready state in one embodiment of this application. Figure 26 This diagram shows the force-holding unit of the inhaler in the activated state.

[0152] When the inhaler is in a dormant state, that is, when the dust cover 104 is closed, the protrusion 1040 on the dust cover 104 cooperates with the support rod 31 of the bracket to lock the bracket 3 in a proximal state. The bracket 3 in the proximal state will abut against the force holding unit, so that the force holding unit is in a proximal state. Specifically, the bracket 3 abuts against the lower cover 47 of the force holding unit and further fixes the compression spring 41 by the retaining ring 45. At this time, there is an axial gap 8 between the lower cover 47 and the canister 12. The compression spring 41 is in a fully compressed state (the fully compressed state refers to the maximum degree of compression of the compression spring during the entire operation of the inhaler) to store energy, and the 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.

[0153] The inhaler transitions from a dormant state to a ready state, corresponding to the opening of the dust cover 104. The support 3 moves distally (this action provides space for the compression spring 41 to release energy). The compression spring 41 releases energy to push the lower cover 47 and the retaining ring 45 distally. Consequently, the flexible skirt 461 of the diaphragm 46 unfolds from its pleated state under the clamping of the lower cover 47 and the retaining ring 45. Furthermore, the annular curved portion 4610 of the flexible skirt 461 is unfolded. This increases the volume of the sealing cavity 7 between the lower cover 47 and the diaphragm 46. When the sealing cavity 7 is sealed, it is under negative pressure, which further increases the seal between the diaphragm 46 and the valve sealing portion 431. The negative pressure within the sealing cavity 7 also generates a proximal force to counteract the distal force generated by the compression spring 41. The movement of the compression spring 41 toward the distal end stops when its force toward the distal end balances the force toward the proximal end (the force toward the proximal end is mainly the force generated by the sealed cavity 7). It should be noted that the movement of the bracket 3 toward the distal end when the dust cover 104 is opened means that the bracket 3 has a movement toward the distal end when the dust cover 104 is open, not that the bracket 3 necessarily only has a movement toward the distal end. Considering the coordination between structural designs, the bracket 3 is also allowed to have a movement toward the proximal end during the opening of the dust cover 104, as long as the amount of movement toward the distal end of the bracket 3 when the dust cover 3 is opened is greater than the amount of movement toward the proximal end.

[0154] It should be noted that the force balance of the compression spring 41 described in the above embodiments only considers the main forces, and does not take into account the minor forces generated by the interaction between the various structures in the inhaler. For example, in some examples, when the lower cover 47 moves toward the distal end, the lower cover 47 occupies the axial gap 8 between the lower cover 47 and the canister 12 when the dust cover 104 is closed and begins to slightly press against the canister 12, causing the canister 12 to slightly compress its valve stem 22 (this slight compression is insufficient to release the drug solution from the valve stem 22 and does not affect the user's use). At this time, the valve stem 22 will generate a small force toward the proximal end. The exemplified minor force is only one example. It is also possible that the lower cover 47 may just contact the canister 12 without generating a force toward the proximal end, or other minor forces may be generated by the interaction between other structures in the inhaler. Since these minor forces contribute very little to the force balance, in the embodiments of this application, the force balance of the compression spring 41 is described by ignoring these minor effects.

[0155] The inhaler transitions from a ready state to an activated state, corresponding to the user inhaling through the inhalation port. At this time, air enters through the air inlet structure and forms an airflow towards the inhalation port within the inhaler. When the torsional force of the airflow acting on the valve vane 430 exceeds the torsional force acting on the valve vane 430 by the valve spring 44 and the sealing cavity 7, the valve 43 rotates, causing the valve sealing part 431 to open the diaphragm 46, allowing air to enter the sealing cavity 7. At this point, the air pressure within the sealing cavity 7 changes from a negative pressure state to atmospheric pressure. Thus, the force exerted by the negative pressure within the sealing cavity 7 towards the proximal end disappears, breaking the force balance in the ready state. Consequently, the compression spring 41 extends further (i.e., further releases energy). As the compression spring 41 extends further, the lower cover 47, the retaining ring 45, and the support 3 move further towards the distal end, causing the canister body 20 to move distally relative to the valve stem 22. Then the valve stem 22 can enter the metering chamber so that the drug solution in the metering chamber is sprayed out from the valve stem 22 in a mist form until the valve stem 22 continues to move to the stop part inside the valve 21, at which point the valve stem 22 stops moving.

[0156] Furthermore, the user can reset the inhaler by closing the dust cover 104. At this time, the support 3 is pushed towards the proximal end by the dust cover 104, which further causes the force holding unit to move towards 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 gas from the sealed cavity 7. Then, under the action of the valve spring 44, the valve 43 rotates and continues to seal the diaphragm 46, so that the sealed cavity 7 is in a vacuum state.

[0157] It should be noted that the force-holding unit and the bracket are not limited to those described in this application. Figures 17 to 22 The structure of the embodiment shown can also be made of other mechanical structures, for example, as long as it can ensure that the force holding unit can activate the canister 12 when the user inhales.

[0158] As in some of the previous embodiments of the dispensing device, the main housing of the dispensing device may be provided with a counting space for placing a dose counter (e.g., Figure 1 The counting space 105 shown, that is, in some embodiments the dispensing device may include a dose counter, that is, in some embodiments of a drug delivery device configured as a respiratory-actuated inhaler, a dose counter may also be included, for example Figure 18 The illustrated respiratory-actuated inhaler also includes a dose counter 5 disposed within the main housing 10. The dose counter 5 is further disposed within a counting space of the main housing 10 for counting the number of uses of the inhaler. It should be understood that the dose counter 5 is disposed as follows: Figure 18The respiratory-actuated inhaler shown is merely an exemplary illustration. In other embodiments, the dose counter 5 may also be configured in any non-respiratory-actuated inhaler, such as manually actuated, actuated by means of an additional actuation mechanism, or actuated by electronic control. It may also be configured in any drug delivery device or any of the aforementioned dispensing devices. The following embodiments illustrate the working principle of the dose counter 5 configured in a respiratory-driven inhaler and are not intended to limit the inhalers to which the dose counter 5 is applicable.

[0159] Further, please refer to Figure 19 The image shown is a schematic diagram of the main housing from another perspective in one embodiment of this application, and is combined with... Figure 18 and Figure 22 As shown, a hole structure 1050 is provided on the counting space 105. The hole structure 1050 can be formed on the proximal sidewall of the counting space 105. The hole structure 1050 allows at least a portion of the structure of the support 3 to pass through to drive the dose counter 5. Figure 22 As shown in the example, the support 3 also includes a drive rod 30 located at the distal end of the support body 32. This drive rod 30 extends through the hole structure 1050 and is used to drive the dose counter 5. The structures of the support 3 and the dose counter 5 will be described in detail later and will not be repeated here. It should be understood that driving the dose counter 5 via the support 3 is only one example. In other examples, other triggering mechanisms may be used to drive the dose counter 5 according to the device's triggering mechanism, or it may be driven manually. This application does not limit the driving source of the dose counter 5.

[0160] Please see Figure 27 and Figure 28 The following are schematic diagrams of the dose counter structure in different embodiments of this application, such as... Figure 27 and Figure 28 As shown, the dose counter 5 includes an actuation mechanism 50 and a counting component 51. The actuation mechanism 50 moves distally when driven, and the counting component 51 counts the number of uses of the inhaler based on the distal movement of the actuation mechanism 50, and indicates the number of uses of the inhaler with a visual numerical representation. The actuation mechanism 50 can be driven in response to different driving operations depending on the actuation mechanism of the inhaler to which it is applied. For example, the actuation mechanism 50 can be driven distally in response to user inhalation, manual triggering, action mechanism triggering, or electrical triggering by an electronic control device.

[0161] In one embodiment, the actuation mechanism 50 is configured to be driven toward a distal end in response to a user's inhalation. The main housing, canister, force-holding unit, and support of the inhaler are arranged as follows: Figures 17 to 26In any embodiment of the example structure shown, the actuation mechanism 50 is further driven to move toward the distal end by the bracket, or the actuation mechanism 50 is part of the bracket and moves toward the distal end along with the bracket when the bracket is driven. In other examples, the actuation mechanism 50 may also be driven to move toward the distal end by a structure that can be linked with the above structure or unit. This application does not limit this.

[0162] In one embodiment, such as Figure 27 As shown, the actuation mechanism 50 includes a drive member 500 and a return spring 501. For example... Figure 8 When the illustrated bracket 3 (specifically, the drive rod 30 of bracket 3) moves distally, it drives the drive member 500 to move distally and compresses the return spring 501. When the bracket 3 moves proximally, the return spring 501 extends, causing the drive member 500 to move proximally. Further, please refer to... Figure 29 This application is shown as being in Figure 27 The schematic diagram of the actuator moving toward the distal end in the embodiment shown is shown in the figure. The driving member 500 includes a driving claw 5000 for driving the counting component 51. When the actuator 50 moves toward the distal end, it can contact the counting component 51 to drive the counting component 51.

[0163] In one embodiment, such as Figure 28 As shown, the actuation mechanism 50 includes a drive member 500, which is configured as a claw formed on the support 3, and further, the claw is formed on the drive rod 32 of the support 3. When driven (i.e., when the support 3 is driven), the drive member 500 moves toward the distal end, so that the drive member 500 can contact the counting component 51 to drive the counting component.

[0164] In one embodiment, such as Figure 27 and Figure 28 As shown, the counting component 51 includes a first counting unit 510 and a second counting unit 511. The first counting unit 510 is driven by the actuation mechanism 50 to count a first set of numbers when the actuation mechanism 50 moves toward the distal end, and the second counting unit 511 is driven to count a second set of numbers when the first counting unit 510 has counted 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.

[0165] The visualized numbers can be Arabic numerals, or they can be represented using Chinese characters or English letters, etc. This application does not limit the language used to represent the numbers. In the following embodiments of this application, Arabic numerals are used as an example for illustration.

[0166] The preset number of times is related to the carry-over timing between the first group of numbers and the second group of numbers. In one embodiment, the preset number of times includes the number of times determined based on the carry-over relationship between the first group of numbers and the second group of numbers in the visualized numbers. It can reflect the timing of the carry-over from the first group of numbers to the second group of numbers for the nth time (n is an integer greater than 1). Taking the first group of numbers and the second group of numbers as a decimal relationship as an example (in this example, the first counting unit can also be called the units 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 count of the first carry-over. Taking the first carry-over as the first count, the second counting unit can be driven to count when the first counting unit performs a count of a positive integer multiple of 10 plus 1. In one embodiment, the preset number of times further includes the number of counts corresponding to the first carry determined based on the initial value of the visualized number. Specifically, based on the initial value and the carry relationship between the two sets of numbers, the timing of the first carry from the first set of numbers to the second set of numbers can be determined. Taking the initial value of the visualized number as 120 as an example, the preset number of times also includes the first count, that is, the second counting unit will be driven to count when the first counting unit performs the first count; taking the initial value of the visualized number as 111 as an example, the preset number of times also includes the second count, that is, the second counting unit will be driven to count when the first counting unit performs the second count; taking the initial value of the visualized number as 112 as an example, the preset number of times also includes the third count, that is, the second counting unit will be driven to count when the first counting unit performs the third count.

[0167] In one embodiment, the counting component 51 can be used to indicate the remaining number of uses in the inhaler or the number of uses already made. For example, if the current counting component 51 displays the number 99, after the user uses the device once, if the counting component 51 indicates the remaining number of uses, then the counting component 51 displays 98; if the counting component 51 indicates the number of uses already made, then the counting component 51 displays 100.

[0168] In an embodiment where the counting component 51 indicates the number of times the device has been used, the visual number presented by the counting component is displayed as a positive number. In this embodiment, in the initial state of the inhaler, the number indicated by the first counting unit and the second counting unit indicates that the inhaler has not been used since it left the factory, for example, indicating a number of 0. After each use, the counting component 51 counts once and increases the number by one, for example, indicating a number of 1.

[0169] In an embodiment where the counting component 51 indicates the remaining number of uses, the visual number presented by the counting component is displayed in a countdown manner. In this embodiment, in the initial state of the inhaler, the number indicated by the first counting unit and the second counting unit in conjunction represents the total number of uses of the inhaler in the initial state (i.e., the total number of uses at the time of manufacture), such as... Figure 28 As shown, the inhaler's initial total usage count is displayed as 120. After each use, the counter component 51 counts once, decreasing the number by one, displaying 119. This way, the user sees the remaining amount of the inhaler each time, helping them to understand the inhaler's remaining lifespan and prepare accordingly. Of course, Figure 34 The display only shows the number of uses after the inhaler leaves the factory. It can also indicate the number of uses tested during the inhaler's production phase, still based on the initial state. Figure 28 Taking the displayed number as an example, after testing during the production phase, the counting component displays the number 120. Therefore, the counting component needs to display a number larger than 120 so that the use of the production phase test prompts the counting component to count down to 120. For example, during the production phase, the counting component displays the number 130, which 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 (i.e., displaying 129, 128, 127, 126, 125, 124, 123, 122, 121, 120 in sequence). These integers and the starting value 130 are used to indicate the number of times the production phase test is performed.

[0170] In subsequent embodiments, the example shown is that the visualized numbers are displayed in a reciprocal manner, which should not be construed as a limitation of this application.

[0171] The number of digits in the first and second sets of numbers is related to the total number of uses of the inhaler. For example, if the total number of uses is a two-digit number (e.g., 99), the combined number of digits in the first and second sets must be at least two digits. In this example, the first set of numbers can be set to one digit, and the second set can be set to one digit. Similarly, if the total number of uses is a three-digit number (e.g., 120), the combined number of digits in the first and second sets must be at least three digits. In this example, the first set of numbers can be set to one digit, and the second set can be set to two digits. The first and second counting units work together to indicate the number of uses in the inhaler using a three-digit number. Specifically, if the total number of uses is 120, the first set of numbers includes ten one-digit numbers from 0 to 9. The second group of numbers includes at least 13 numbers from 0 to 12. Thus, the first group of numbers and the second group of numbers can be combined to display one, two, or three digits. In other words, the first group of numbers and the second group of numbers can be combined to display at least all integer digits from 0 to 120, that is, at least 0, 1, 2, 3, ..., 119, 120.

[0172] The total number of uses for the inhaler can be set to include only the total number of uses in the initial state, or it can be set to include both the total number of uses during the production phase testing and the total number of uses in the initial state. For example, if the total number of uses for the inhaler is configured to be 120 uses in the initial state, the second set of numbers can include numbers from 0 to 12. This, combined with the first set of numbers, can display 120, 119, ..., 3, 2, 1, 0, indicating the number of uses after the inhaler leaves the factory. Alternatively, if the total number of uses for the inhaler also includes 10 uses during the production phase testing, then the second set of numbers needs to include more numbers than 12 for display during the production phase. That is, the second set of numbers includes numbers from 0 to 13, and combined with the first set of numbers, can display 130, 129, ..., 120, 119, ..., 3, 2, 1, 0. 130, 129, ..., 121, 120 can be displayed during the production phase of the inhaler; after leaving the factory, the inhaler displays 120, 119, ..., 3, 2, 1, 0. Of course, in other examples, the production testing phase may not require configuring a numerical display; that is, 13 may not be set, and only a blank space may be reserved. The same understanding applies when the total number of uses of the inhaler is a two-digit number, and it can be set in a similar way, which will not be elaborated upon here.

[0173] In one embodiment, a propulsion unit can be provided so that when the first counting unit 510 performs a preset number of counts, it can drive the second counting unit to perform a second set of digit counts. For example... Figure 27 and Figure 28As shown, the counting component 51 further includes a propulsion unit 512 that engages with the second counting unit 511. When the first counting unit 510 performs a preset number of counts, it engages with the propulsion unit 512 to drive the second counting unit 511 to count. In other words, the first counting unit 510 engages with the propulsion unit 512, and after the propulsion unit 512 engages 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 contacting and mating mechanism that creates a linkage, such as locking or meshing.

[0174] In one embodiment, please refer to Figure 30 The figure shows a schematic diagram of the propulsion unit in one embodiment of this application. As shown, the propulsion unit 512 includes a first gear 5120 and a second gear 5121 that have a linkage relationship. Figure 27 and Figure 28 As shown, the first gear 5120 is driven by the first counting unit 510 to rotate the second gear 5121 when the first counting unit 510 counts a preset number of times. The second gear 5121 engages 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. Thus, when the first gear 5120 is driven to rotate by the first counting unit 510, the connecting rod 5122 will further drive the second gear 5121 to rotate, thereby driving the second counting unit 511 to count.

[0175] In one embodiment, please refer to Figure 31The figure shows a schematic diagram of the split structure of the first and second counting units in one embodiment of this application. As shown, the first counting unit 510 includes a first counting wheel 5101 with a first set of numbers marked on its circumference, and the second counting unit 511 includes a second counting wheel 5110 with a second set of numbers marked on its circumference. The first counting wheel 5101 and the second counting wheel 5110 are arranged side-by-side. When driven, the first and second counting wheels rotate to display their respective numbers in a display window, indicating the number of times the inhaler has been used by combining the two sets of numbers. For example, each time the inhaler is used, the first counting wheel 5101 rotates once to change the number and displays the changed number in the display window. After the first counting wheel 5101 rotates a preset number of times, the second counting wheel 5110 rotates once to change the number and displays the changed number in the display window. The number formed by combining the two sets of numbers indicates the number of uses. The display window is a window on the inhaler that allows light to enter, so that the user can observe the numbers displayed on the counting wheels through the display window.

[0176] It should be noted that although the numbers are marked on the counting wheel in this application, it is not limited thereto. In other embodiments, the first set of numbers and the second set of numbers may also be set on a belt that can be unwound with the reel.

[0177] In one embodiment, such as Figure 31 As shown, the second counting unit 511, in addition to the second counting wheel 5110, also includes a second actuating gear 5111 for interaction with the propulsion unit. The second actuating gear 5111 has a plurality of teeth spaced apart in a circumferential direction. The propulsion unit drives one tooth of the second actuating gear 5111 to move, thereby 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 can be directly or indirectly connected, or they can be formed by an integral structure.

[0178] The number of teeth on the second actuating gear 5111 is related to the number of digits in the second set of numbers, and must be no less than the number of digits in the second set of numbers. For example, if the second set of numbers 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, the number of teeth on the second actuating gear 5111 is 14. Furthermore, if the second set of numbers 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.

[0179] In one embodiment, such as Figure 31 As shown, 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 and 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 can also be sleeved on the shaft element 5100.

[0180] Please see Figure 32 and Figure 33 The following are schematic diagrams of the structure of the first counting unit in different embodiments, such as... Figure 32 and Figure 33 As shown, the first counting unit 510 further includes a first actuating gear 5102 fixed to the shaft element 5100, which has a plurality of teeth spaced apart in the circumferential direction. The actuating mechanism moves against one of the teeth toward the distal end to cause the first counting wheel 5101 to rotate one count. Specifically, please refer to... Figure 32 and combined Figure 29 The driving pawl 5000 of the actuation mechanism 50 abuts against one of the teeth of the first actuation gear 5102, causing the first counting wheel 5101 to rotate one count when the driving pawl 5000 moves toward the distal end. See also... Figure 33 and combined Figure 28 The driving member 500 of the actuation mechanism 50 abuts against one of the teeth of the first actuation gear 5102, causing the first counting wheel 5101 to rotate by one count when the driving member 500 moves toward the distal end. In one embodiment, when the first group of numbers in the first counting unit 510 is set to 1 digit, the first group of numbers marked on the first counting wheel includes ten integers: 0, 1, 2, 3, 4, 5, 6, 7, 8, and 9. The gear has 10 teeth corresponding to the ten integers, with each tooth corresponding to one number in the first group of numbers. That is, when a tooth is driven, the number corresponding to that tooth will be rotated to a position that can be observed by the user, such as rotating to the display window described below.

[0181] In one embodiment, such as Figure 32 and Figure 33 As shown, the first counting unit 510 further includes a single-tooth element 5103, which is fixed to the shaft element 5100 or the first actuating gear 5102 to rotate with the shaft element 5100 or the first actuating gear 5102. When the first counting unit 510 performs a preset number of counts, the single-tooth element 5103 rotates in contact with the propulsion unit to drive the second counting wheel 5110 to rotate. Figure 27 and Figure 28 In the example shown 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, depending on the structure and installation position of the propulsion unit, the single-tooth element 5103 can also be positioned in different locations. For example, if the propulsion unit 512 is located below the first counting unit 510 and the second counting unit 511, then the single-tooth element 5103 can be located above the propulsion unit 512.

[0182] Furthermore, combined Figure 29 and Figure 30 Taking the pusher unit configured as including a first gear 5120 and a second gear 5121 as an example, for Figure 32 and Figure 33 The following example illustrates how the single-tooth element 5103 drives the second counting wheel 5110 to count. Specifically, when the actuation mechanism 50 is driven, it interacts with one tooth of the first actuation gear 5102, causing the first counting wheel 5101 and the single-tooth element 5103 to rotate. This can be understood as the first counting assembly 51 rotating as a whole, with each rotation corresponding to one count by the first counting wheel. Before each preset number of counts, the single-tooth element 5103 moves to a pre-engagement position, as shown... Figure 29 The single-tooth element 5103, in its current state, will rotate with the first actuating gear 5102 through the tooth in the first gear 5120 of the pushing unit 512 that is in the pre-engaged position during the preset count. This will push the tooth away from the preset engagement position, causing the first gear 5120 of the pushing unit 512 to drive the second gear 5121 to rotate once. The second gear 5121 will then drive the second counting wheel 5110 to rotate once. When the single-tooth element 5103 pushes the tooth in the first gear 5120 that is in the pre-engaged position away from the preset engagement position, the next tooth of the first gear 5120 moves to the pre-engaged position to contact the single-tooth element 5130 when it returns to this position for the next count of the second counting wheel.

[0183] Taking the initial state where the counting component displays the number 120 as an example, the preset number of counts includes the first count and counts that are multiples of 10 plus 1, such as the 1st, 11th, 21st, 31st, 41st, 51st, 61st, 71st, 81st, 91st, 101st, 111th, and 121st counts. Before the first count, the single-tooth element 5103 and the first tooth of the first gear 5120 are in a preset engagement position. Thus, when the first count is performed, the single-tooth element 5103 pushes the first tooth to make the pushing unit rotate once, which in turn causes the second counting wheel to rotate once, and the counting component displays the number 119. Subsequently, the second tooth of the first gear 5120 is in a preset engagement position, and the single-tooth element 5103 leaves the preset engagement position. During the 2nd to 10th counts, the single-tooth element 5103 moves once each time, returning to the preset engagement position upon completion of the 10th count. Thus, during the 11th count, the single-tooth element 5103 pushes the second tooth, causing the pushing unit to rotate a second time, which in turn causes the second counting wheel to rotate a second time, and the counting component displays the number 109. This cycle repeats. During the 111th count, the single-tooth element 5103 pushes the 12th tooth, causing the pushing unit to rotate a 12th time, which in turn causes the second counting wheel to rotate a 12th time, and the counting component displays the number 9. During the 121st count, the counting component displays the number 0, indicating that the maximum count has been exceeded. In some embodiments, such as those including subsequent embodiments with signal elements, the single-tooth element 5103 pushes the 13th tooth, causing the pushing unit to rotate a 13th time, which in turn causes the second counting wheel to rotate a 13th time, allowing the signal element to obscure the display of the counting component.

[0184] It should be understood that the pre-engagement position refers to the position corresponding to which the single-tooth element and the propulsion unit can generate transmission motion. It does not represent a fixed position point, but rather indicates that in the pre-engagement position, the continued movement of the single-tooth element can contact and drive the movement of the propulsion unit. Furthermore, Figure 29 Therefore, the actuation mechanism 50 is configured as follows: Figure 27 The following explanation uses the structure shown as an example to illustrate how the single-tooth element 5103 drives the second counting wheel 5110 to count. The actuation mechanism 50 adopts the following... Figure 28 The structure shown illustrates the principle of the single-tooth element 5103 driving the second counting wheel 5110 for counting. Figure 29 The same applies, so I won't repeat it here.

[0185] To prevent further counting by the dose counter after the inhaler has reached its maximum number of uses, in one embodiment, a stop structure is provided on the first gear of the propulsion unit. When the maximum number of counts is exceeded, the single-tooth element pushes the first gear to rotate the stop structure to the preset engagement position to stop the single-tooth element from driving the propulsion unit. Alternatively, it can be described as causing the propulsion unit to lose contact with the single-tooth element.

[0186] Please see Figure 34 The image shown is a schematic diagram of the propulsion unit in one embodiment of this application. Figure 35 This application is displayed as being in Figure 34 The diagram showing the operational state of the stopping structure in the propulsion unit is as follows: Figure 34 and Figure 35 As shown, the first gear 5120 of the propulsion unit 512 is equipped with a stop structure 5123. 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 pre-engagement position (as shown). Figure 35 (As shown in (b) and (c)) the state is such 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 push unit 512 and preventing the counting of the second counting wheel. In a specific example, the stopping structure 5123 is configured as a missing tooth (or recess) on the first gear 5120, which is located after the last tooth 51200 of the first gear 5120. The last tooth 51200 corresponds to the tooth that is driven to rotate by the single-tooth element 5103 when the maximum number of uses has been exceeded. Before the counting exceeds the maximum number of uses, the single-tooth element 5103 and the first gear 5120 are in the following position. Figure 35 In the state shown in (a), the last tooth 51200 and the single tooth element 5103 are in the pre-engaged position. Therefore, during the final count, the single tooth element 5103 pushes the last tooth 51200 to rotate, causing the second counting wheel to rotate once. This causes the last tooth 51200 to leave the preset engagement position, and the stopping structure 5123 reaches the preset engagement position (as shown in the diagram). Figure 35 The state shown in Figure (b) indicates that the stopping structure 5123 reaches the preset engagement position, preventing the first gear 5120 from contacting the single-tooth element 5103, even if the single-tooth element 5123 moves back to the pre-engagement position (as shown in Figure (b)). Figure 35 When the state presented in (c) is to be used for the next count, the single tooth element 5123 can only pass through the stop structure 5123 without contact.

[0187] Continuing with the example of the counting component displaying the number 120 in the initial state, the preset number of times includes the 1st, 11th, 21st, 31st, 41st, 51st, 61st, 71st, 81st, 91st, 101st, 111th, and 121st times. Figure 34 The push unit 512 shown is described below. The count that exceeds 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 be in the pre-engagement position. Therefore, when the count continues after the 121st count, the single tooth element 5123 will no longer be able to contact the push unit 512 and will no longer have a driving effect on the push unit 512.

[0188] It should be noted beforehand that in embodiments where the counter also includes the signal elements described later, such as Figure 34 and Figure 35 The push unit shown enables the second counting unit to rotate once when counting exceeds the maximum number of uses, so that the signal element obscures the display of the counting component (see the following embodiments 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 visible to the user.

[0189] In one implementation, the actuation mechanism 50 moves toward the distal end such that when the counting component 51 counts, the corresponding number on the first counting wheel 5101 is offset from the correct display position in the display window. For example, see [link to relevant documentation]. Figure 27 , Figure 28 and 21 , Figure 36 The diagram shows a digit displayed by the counting component in one embodiment of this application offset from the display window. As shown, when the drive member 500 of the actuation mechanism 50 moves toward the distal end, it drives the first counting wheel 5101 to rotate clockwise. After the movement stops, the digits on the first counting wheel 5101 (e.g., ...) are displayed. Figure 36 The number 9 in the display window 56 is offset from the center position C.

[0190] When the actuation mechanism 50 moves towards the proximal end to reset, it causes the first counting wheel 5101 to rotate in the opposite direction of counting, so that the corresponding number on the first counting wheel 5101 is displayed in the correct position in the display window. For example, see [link to relevant documentation]. Figures 36 to 38 and combined Figure 9 and Figure 27 , Figure 37 This application is displayed as being in Figure 27 The illustrated embodiment shows a schematic diagram of the actuator moving towards the proximal end. Figure 38This diagram illustrates how, in one embodiment of this application, the counting component correctly displays the numbers in the display window. After the user inhales the medication once, the dust cover 104 is closed. As the dust cover 104 rotates to the closed position, the protrusion 1040 of the dust cover 104 supports the bracket 3, thereby causing the drive mechanism 500 of the actuation mechanism 50 to move proximally under the action of the return spring 501. When the actuation mechanism 50 moves proximally, it can cause the first counting wheel 5101 to rotate in the opposite direction to the counting direction (e.g., counterclockwise), so that the numbers on the first counting wheel 5101 are displayed in the correct position in the display window (i.e., the center position of the display window). Furthermore, when the actuation mechanism 50 moves proximally, its drive pawl 5000 deforms towards the actuation mechanism 50 to pass over the next tooth on the first actuation gear 5102 (the tooth adjacent to the currently engaged tooth and close to the proximal end) and engage with the next tooth. When the actuating mechanism 50 moves toward the distal end again, the driving pawl 5000 can continue to drive the first counting wheel 5101 to rotate via the teeth that engage with it. Figure 36 and Figure 38 As shown, when the actuation mechanism 50 moves toward the proximal end, the drive pawl 5000 engages with the teeth on the first actuation gear 5102 and drives the first counting wheel 5101 to rotate clockwise. After the actuation mechanism 50 stops moving, the number 9 on the first counting wheel 5101 is offset from the center position of the display window. When the actuation mechanism 50 moves toward the proximal end, the drive pawl 5000 will disengage from the currently engaged tooth and engage with the next tooth, so that the number 9 on the first counting wheel 5101 is displayed in the correct position in the display window.

[0191] It should be understood that, Figure 37 Therefore, the actuation mechanism 50 is configured as follows: Figure 27 Taking the structure shown as an example, the reset process ensures that the numbers are correctly displayed in the display window 56. The actuation mechanism 50 employs, for instance... Figure 28 The structure shown allows the numbers to be displayed correctly in display window 56. Figure 27 Similar, the only difference is that Figure 28 The actuation mechanism 50 does not require a return spring for reset. Specifically, when the user closes the dust cover 104 after one medication inhalation, as the dust cover 104 rotates to the closed position, the protrusion 1040 of the dust cover 104 supports the bracket 3. Figure 28 The drive element 500 included in the actuation mechanism 50 is formed on the support 3 and can move proximally along with the support 3. During this process, the drive element 500 moves in a manner similar to... Figure 37 The process shown and described enables the numbers to be displayed correctly in display window 56.

[0192] It should be noted that after the actuation mechanism moves towards the distal end, if the first counting unit achieves the preset number of counts,

[0193] When the second counting wheel 5110 is driven, the number on the second counting wheel 5110 also shifts to the center position of the display window. Upon reset, the number on the second counting wheel 5110 can also be displayed in the correct position in the display window.

[0194] In one embodiment, such as Figure 27 and Figure 28 As shown, the counting component 51 further includes a bottom frame 513 for configuring the first counting unit 510 and the second counting unit 511. See also... Figure 39 The diagram shows a schematic representation of the counting component from one perspective in one embodiment of this application. The bottom frame 513 may be provided with a first positioning claw 5130 corresponding to a first counting unit and a second positioning claw 5131 corresponding to a 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 at the center of the display window.

[0195] In this configuration, the first positioning claw 5130 or the second positioning claw 5131 can prevent the counter-rotation of the counting unit by engaging, thereby ensuring the correct display of the numbers. In some embodiments, the first positioning claw 5130 can be engaged with, for example,... Figure 32 or Figure 33 The teeth on the first actuating gear 5102 of the first counting unit 510 shown engage to prevent the first actuating gear 5102 from continuing to rotate counterclockwise when it rotates counterclockwise. Similarly, the second positioning claw 5131 can engage with the teeth on the first actuating gear 5102 as shown in the figure. Figure 31 The teeth on the second actuation gear 5111 of the second counting unit 511 shown engage to abut against the teeth on the second actuation gear 5111 when the second actuation gear 5111 rotates counterclockwise, thereby preventing the second actuation gear 5111 from continuing to rotate counterclockwise.

[0196] To meet the requirements of space saving, rational layout, and compact structure, in one embodiment, such as Figure 33 As shown, the first counting unit 510 may further include a first stop gear 5104, and the first positioning claw 5130 is engaged with... Figure 33The first stop gear 5104 shown engages to prevent the first counting unit 510 from rotating in the reverse direction. The first stop gear 5104 of the first counting unit 510 corresponds to 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... Figure 31 The second counting unit 511 may further include a second stop gear 5112, and the second positioning claw 5131 is connected to the second stop gear 5112 via a stop gear 5112. Figure 31 The second stop gear 5112 shown cooperates to prevent the reverse rotation of the second counting unit 511. 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.

[0197] Specifically, the first counting unit is configured as follows: Figure 33 Taking the first stop gear 5104 as an example, when the first counting wheel 5101 rotates clockwise, one tooth on the first stop gear 5104 of the first counting unit can pass over the first positioning pawl 5130. When the actuation mechanism 50 stops moving, the corresponding number on the first stop gear 5104 shifts to 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 actuation mechanism 50 stops moving, the tooth on the first stop gear 5104 corresponding to the number 8 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 it. During reset, the first stop gear 5104 rotates counterclockwise, causing the tooth corresponding to the number 8 to engage with the first positioning pawl 5130, thus preventing the tooth corresponding to the number 8 from passing over the first positioning pawl 5130 in the reverse direction.

[0198] By setting the first positioning claw 5130 and the second positioning claw 5131, excessive rotation of the counting wheel in the opposite direction to the counting direction can be prevented, ensuring accurate dose display. Furthermore, it also ensures accurate dose display even when the inhaler is dropped or shaken.

[0199] In one embodiment, the bottom frame 513 further includes a mounting portion for securing the shaft element 5100 and / or the connecting rod 5122. The mounting portion is a groove, recess, or similar structure. For example, see [reference needed]. Figure 37 and combined Figure 27 and Figure 28The bottom frame 513 includes two first mounting portions 5132 symmetrically arranged for fixing the shaft element 5100, and two second mounting portions 5133 symmetrically arranged for fixing the connecting rod 5122.

[0200] In one embodiment, such as Figure 27 and Figure 28 As shown, the dose counter also includes a signal element 514, which is used to move to the display window to notify the user when the number of uses of the inhaler reaches a preset number of uses. Specifically, the signal element 514 is connected to the counting component 51, and is driven by the counting component to appear in the display window to notify the user when the number of uses of the inhaler reaches the preset number of uses. The preset number of uses includes, but is not limited to, less than 0 times, and any number of times in the units or tens place. In the following embodiments, the visual number displayed by the counting component is used to indicate the remaining number of uses in the inhaler as an example.

[0201] In one embodiment, please refer to Figure 40 and Figure 41 The figures show schematic diagrams of the signal element structure in different embodiments of this application. As shown, the signal element 514 includes a body part 5140. When the number of times the inhaler is used reaches a preset number of times, the body part 5140 moves to the display window to prompt the user.

[0202] In one embodiment, the body portion 5140 engages with the second counting unit to move to the display window as the second counting unit counts. Specifically, before moving to the display window, the body portion 5140 is located inside the dose counter (i.e., inaccessible to the user), and can move from the inside to the display window as the second counting unit rotates. See also [example description needed]. Figure 42 The figure shows a schematic diagram of the engagement of a signal element and a second counting wheel in one embodiment of this application. As shown, the body portion 5140 engages with the second counting wheel 5110 of the second counting unit and can rotate with the second counting wheel 5110. For example, the body portion 5140 is provided with a locking portion 5142 to engage with the second counting wheel 5110 by locking the locking portion 5142 onto the second counting wheel 5110. The locking method is, for example, a spline engagement. It should be noted that the second counting unit can also engage with the body portion 5140 in other ways or with other components in the second counting unit (such as the second actuating gear 5111), as long as the body portion 5140 can contact the second counting unit and be driven by the second counting unit to move to a display window when the number of uses reaches a preset number.

[0203] In one embodiment, such as Figure 40 and Figure 41 As shown, the body portion 5140 has a stepped outer contour, which can block different digits in the display window in stages. The specific shape of the body portion 5140 is related to the number of stages it needs to block different digits in the display window and the difference between the two digits blocked in adjacent stages. Specifically, the number of steps in the body portion 5140 is the same as the number of stages it needs to block different digits in the display window. For example, when the body portion 5140 needs to block the hundreds, tens, and units digits in three stages, the body portion 5140 has... Figure 40 and Figure 41 The three steps shown are (first step 51400, second step 51401, and third step 51402). When the inhaler is used a first preset number of times, the first step 51400 moves to cover the hundreds digit in the display window as the second counting unit counts. When the inhaler is used a second preset number of times, the second step 51401 moves to cover the display window as the second counting unit counts, together with the first step 51400, to cover the hundreds and tens digits. When the inhaler is used more than the maximum number of times, the third step 51402 moves to the display window as the second counting unit counts, together with the first step 51400 and the second step 51401, to cover all digits.

[0204] Furthermore, the size of each step portion of the main body 5140 is related to the difference between the two digits obscured in the adjacent stages. For example, if the main body 5140 obscures the hundreds digit when the first preset number of uses is 19 and the tens digit when the second preset number of uses is 9, and the difference between the two digits is 10, then the first step portion 51400 of the main body 5140 needs to rotate once with the second counting unit. Correspondingly, the size of the first step portion 51400 must ensure that the hundreds digit is obscured in this one rotation.

[0205] In one example, the first preset usage count is configured to 19 uses remaining, and the second preset usage count is configured to 9 uses remaining. Exceeding the maximum usage count corresponds to counting after 0 uses remaining. That is, when the visual number displayed by the counting component is 19, the main body obscures the hundreds digit; when the visual number displayed by the counting component is 9, the main body obscures the hundreds and tens digits, and the counting component displays 0. If counting continues, the main body will obscure all digits, i.e., the hundreds, tens, and units digits. Specifically, as the counting component counts down from 20 to 19, the first step portion 51400 of the main body 5140 moves to the display window and is positioned corresponding to the hundreds digit. As the counting component counts down from 10 to 9, the second step portion 51401 of the main body 5140 also moves to the display window, occupying the tens digit position to jointly indicate to the user that less than 10 uses remain. As the counting component continues to count down from the number 0, the third step 51402 of the main body 5140 moves to the display window and occupies the unit position to jointly indicate to the user that it can no longer be used, together with the first step 51400 and the second step 51401.

[0206] In one embodiment, please refer to Figure 43 and combined Figure 40 , Figure 43 This application is shown to include Figure 40 The schematic diagram of the counting component in the embodiment of the signal element shown is as follows: Figure 40 and Figure 43 As shown, the signal element 514 further includes a connecting portion 5141 extending from the body portion 5140. The connecting portion 5141 is radially rotatably engaged with the first counting unit 510, allowing the signal element 514 to rotate relative to the first counting unit 510. For example, the connecting portion 5141 is radially engaged with the shaft element 5100 of the first counting unit 510, and the connecting portion 5141 can rotate with the second counting unit relative to the shaft element 5100.

[0207] For further information, please refer to [link / reference]. Figure 40 , Figure 43 ,and Figure 44 ,in Figure 44 This application is displayed as being in Figure 40The schematic diagram of the relative positional relationship between the signal element and the actuation mechanism in the illustrated embodiment is shown in the figure. A stop portion 51410 is formed on the engagement portion 5141. Correspondingly, the actuation mechanism 50 includes a stop claw 5001. When the maximum number of uses of the inhaler is exceeded, the movement of the actuation mechanism 50 toward the distal end causes the second counting unit 511 to rotate the stop portion 51410 above the stop claw 5001, thereby preventing the actuation mechanism 50 from resetting. The stop claw 5001 of the actuation mechanism 50 is misaligned with the driving claw 5000. Specifically, when the counting component displays 0, there is still a remaining dose in the inhaler canister for the user to inhale. When the user continues to inhale, the actuation mechanism 50 drives the first counting unit to rotate, which in turn drives the second counting unit 511 to rotate. For example, the drive claw 5000 of the actuation mechanism 50 drives the first counting unit to rotate (e.g., the number 9 on the first counting unit is located in the display window), which in turn engages with the propulsion unit, causing the propulsion unit to rotate, which in turn causes the propulsion unit to drive the second counting wheel 5110 to rotate. Thus, the signal element 514 rotates with the second counting wheel 5110 to above the stop claw 5001. During the user's closing of the dust cover 104, the actuation mechanism 50 of the inhaler moves proximally; however, the actuation mechanism 50 can only move to the position where its stop claw 5001 abuts against the stop portion 51410. In other words, the stop portion 51410 above the stop claw 5001 prevents the actuation mechanism 50 from moving further proximally, preventing the actuation mechanism 50 from returning to the proximal state before medication dispensing. At this point, the signal element (e.g., the third step 51402 of the signal element) will block the unit digit (e.g., block the number 9 in the display window), so that the entire display window is blocked by the signal element. Since the position of the actuation mechanism 50 is restricted to driving the tooth in the display window containing the number 8 before it passes the next tooth, the counting component will not continue to rotate when the user continues to inhale. In other words, the stop on the signal element can prevent the dose counter from counting further when the maximum number of uses of the inhaler is exceeded.

[0208] In one embodiment, the signal element may be a striking color to more easily attract the user's attention. For example, the signal element could be red, yellow, or similar colors. Alternatively, the color of the signal element may differ significantly from the colors of other visible parts of the dose counter. For instance, if the other visible parts of the dose counter are generally light-colored, the signal element could be a darker color such as black.

[0209] In one embodiment, please refer to Figure 27 and combined Figure 18As shown in the figure, the dose counter 5 further includes a counter housing 52, which accommodates the actuation mechanism 50 and the counting component 51 to mount the dose counter 5 onto the inhaler. The counter housing 52 has grooves, recesses, or similar structures to accommodate the actuation mechanism 50 and the counting component 51. The actuation mechanism 50 and the counting component 51 can be fixed to the counter housing 52 using a snap-fit ​​structure or screw fastening. The counter housing 52 can engage with the main housing 10 to mount the actuation mechanism 50 and the counting component 51 into the counting space 105. In any of the foregoing embodiments, a display window can be provided on the counter housing 52 to display visual numbers to the user.

[0210] Furthermore, such as Figure 27 As shown, a display element 520 is disposed on the display window, and the display element 520 is used to magnify the numbers located in the display window. In one example, the display element 520 includes a magnifying portion 5200 and a blocking portion 5201 extending to both sides from the magnifying portion 5200. The magnifying portion 5200 is located in the middle area of ​​the display window to magnify the numbers in the display window, and the blocking portions 5201 on both sides are located in the upper and lower areas of the display window respectively to block the upper and lower areas. Further, the blocking portions 5201 on the upper and lower sides can also be used to connect with the counter housing 52 to fix the display element 520 to the display window. In one example, as shown... Figure 27 As shown, the display element 520 is configured as a concave structure with a convex surface. The concave structure is recessed in the direction of the convex surface to form a planar area and side areas located on both sides of the planar area. The planar area and the convex surface form the magnifying portion 5200, and the side areas and the convex surface form the blocking portion 5201. Further, the display element 520 can be configured as a transparent material, with the planar area configured as a smooth surface and the side areas configured as rough surfaces. This allows the numbers on the counting component to be presented to the user through the magnifying portion 5200, while the side portions cannot be presented to the user due to the rough surfaces. Of course, it is also possible to configure only the magnifying portion 5200 of the display element 520 as a transparent material, and the blocking portion 5201 as an opaque or semi-transparent material; this application does not impose any limitations on this.

[0211] In one specific embodiment, the dose counter counts as follows: In the initial state of the inhaler, the first and second counting units cooperate to display the number 120, indicating that the total number of uses in the initial state of the inhaler is 120 doses. When the user opens the dust cover 104 of the dose counter, the protrusion 1040 of the dust cover 104 releases the support 3, allowing the support 3 to move distally and achieve force balance with the force maintaining unit. Then, when the user inhales through the inhalation port to inhale one dose of the drug solution, the support 3 (e.g., the drive rod 30 of the support 3) moves distally and drives the drive member 500 to move distally. As the drive member 500 moves distally, it drives the first counting wheel 5101 of the first counting unit 510 to rotate, at which time the rotation of the first counting wheel 5101 rotates the number 9 to the correct display position offset from the display window. During this process, the single-tooth element 5103 of the first counting unit 510 rotates to engage with the propulsion unit 512 to drive the second counting wheel 5110 to rotate, so that the second counting wheel 5110 rotates the number 11 to the correct display position offset from the display window. Then, after the user closes the dust cover 104, the bracket 3 moves towards the proximal end, causing the drive member 500 to move towards the proximal end. As the drive member 500 moves towards the proximal end, it drives the first actuating gear 5102 to cause the first counting wheel 5101 to rotate in the opposite direction to the counting direction, and under the drive of the propulsion unit, the second counting wheel 5110 also rotates in the opposite direction to the counting direction. Thus, the numbers on the first counting wheel 5101 and the second counting wheel 5110 can be displayed in the correct position in the display window, i.e., 119 is displayed in the correct position in the display window. Specifically, after the first actuating gear 5102 of the first counting unit and the second actuating gear 5111 of the second counting unit rotate in opposite directions to the counting direction, they can engage with the first positioning claw 5130 and the second positioning claw 5131 respectively to prevent counting errors. Furthermore, using the above counting method, when the number displayed by the counting component is 19, the body 5140 of the signal element is moved to a display window to block the hundreds digit. When the number displayed by the counting component is 9, the body 5140 can be further moved to the tens digit position in the display window. After the number displayed by the counting component is 0, when the user continues to inhale the medication, the first counting unit rotates again, driving the second counting unit to continue rotating. The body 5140 can then be further moved to the units digit position in the display window to completely block the hundreds, tens, and units digits. By setting a signal element, the user's attention can be drawn to how much dosage remains in the inhaler.

[0212] Among them, the driving unit is configured as follows Figure 34 and Figure 35In the embodiment of the structure shown, after the counting component displays the number 0 (i.e., the maximum count has been reached), when the inhaler continues to be driven, the signal element 514 moves with the second counting wheel 5110 to the display window, completely obscuring the hundreds, tens, and units digits in the display window. However, at this time, the stop structure 5130 provided on the push unit 512 is in the pre-engagement position, so that the first counting component 510 no longer has a driving effect on the second counting component 511, and the signal element remains obscuring the units, tens, and hundreds digits on the display window, preventing the counting component from counting beyond the maximum number of uses and misleading the user.

[0213] Among them, the signal elements are configured as follows Figure 40 In the embodiment of the structure shown, after the counting component displays the number 0, as the user continues to inhale, the signal element 514 rotates with the second counting wheel 5110 to above the stop claw 5001. During the user's closing of the dust cover 104, the actuation mechanism 50 of the inhaler moves proximally; however, the actuation mechanism 50 can only move to the position where its stop claw 5001 abuts against the stop portion 51410. This ensures that the ones, tens, and hundreds digits on the display window are always obscured, preventing errors in the counting component's display and thus avoiding adverse effects on the user.

[0214] In summary, this application achieves accurate counting of usages by incorporating a matching first and second counting unit within the dose counter, and using these units to visually indicate the number of uses of the inhaler. Furthermore, a signal element is included to alert the user to the remaining dose in the inhaler. Additionally, a stop on the signal element prevents the drive mechanism from continuing to operate the first and second counting units after the signal element is partially blocked, thus preventing the dose counter from incorrectly indicating the number of uses.

[0215] In summary, the dispensing device, drug delivery device, inhaler, and respiratory-actuated inhaler disclosed in this application replace the injection part in related technologies with a jet body that is detachably configured in the main housing. This allows the main housing and the jet body to be designed or modified separately as two independent components, which is beneficial for improving injection performance and facilitating production and mold adjustment.

[0216] To verify the differences in drug delivery performance between the proposed split-type dispensing device and the drug delivery device, inhaler, and respiration-actuated inhaler using the split-type device, and the conventional integrated drug delivery device of the prior art, and to further explore the influence of different materials and different nozzle internal geometries on atomization performance, multiple sets of comparative experiments were constructed in this application. The experiments were used to evaluate the influence of different materials and different nozzle structures on aerodynamic performance and drug delivery characteristics of the split-type structure while ensuring dosage accuracy.

[0217] This experiment selected samples from the comparative and example embodiments for testing, where:

[0218] Comparative Example: A commercially available, representative traditional integrated MDI device (model: Redihaler, internal sample number: 26073B) was selected as a benchmark. The main housing and injection section of this device are integrally injection molded (usually made of plastic), serving as a representative example of a traditional integrated design in the prior art.

[0219] Example: The split-type dispensing device described in this application was selected. The experiment used a main body of the same specification (POC2 Main body, No. 20), and separately assembled separable injectors with different material properties or internal structures. Based on the different materials and structures of the injectors, the example was further subdivided into different material groups and different orifice groups. The different material groups refer to injectors made of plastic (PP, polypropylene), metal (316 Stainless Steel), and micro / nano resin (ST Nano-resin, photosensitive resin / micro / nano resin), while maintaining basically consistent orifice geometry.

[0220] Different orifice groups refer to various internal flow channel designs tested for split-type jets, including single-hole design (sample number: POC2-SZ01), multi-hole array design (including 2-hole, 3-hole, and 4-hole), and converging nozzle design (sample number: POC2-SZ08).

[0221] The experiment tested the key performance indicators of the above samples according to relevant industry testing standards (such as LSP-GW012-004.01 and other internal or industry-standard testing methods). To clearly demonstrate the technical effects verified by each test, Table 1 summarizes the test items, corresponding methods, and their relationships in subsequent experimental analysis, as shown in Table 1:

[0222] The specific definitions of the test items listed in Table 1 are as follows (among which, the spray geometry test is used as an auxiliary evaluation parameter in this application, and its results are used to interpret and corroborate the changing trends of indicators such as spray area, fine particle mass, and spray velocity):

[0223] Dosage Delivery Uniformity (DDU) Test: Performed according to the TM-GW012-DP-02 method. This test measures the consistency of the dose delivered with each press of the device to assess the reliability of drug release under repeated disassembly and reassembly of the modular design.

[0224] Plume Velocity Test: Performed according to the TM-GW013-DP-13 method. Used to evaluate the leading edge velocity of the plume as the spray exits the nozzle. Lower spray velocities (i.e., soft mist characteristics) are generally associated with less throat impact tendency and improved lung delivery characteristics.

[0225] Aerodynamic Particle Size Distribution (APSD): Measured using an Anderson Cascade Impactor (ACI) according to the TM-GW012-DP-01 method. APSD characterizes the particle properties produced by aerosol (MDI) products. APSD describes the distribution of particle mass at different aerodynamic diameters and is directly influenced by the median mass aerodynamic diameter (MMAD), geometric standard deviation (GSD), impactor size mass (ISM), and fine particle mass (FPM). MMAD represents the 50% particle mass smaller than this diameter, reflecting the overall particle fineness. GSD describes the distribution width of particles near the MMAD. ISM reflects the mass of particles within the diameter range. FPM describes the amount of drug that can enter the lower respiratory tract.

[0226] Spray Pattern Test: Conducted according to the TM-GW012-DP-07 method, this test evaluates the spatial distribution of the spray on the target surface (such as spray area and ellipticity) to verify the nonlinear control capability of the porous design on the spray coverage.

[0227] Plume Geometry: Performed according to the TM-GW012-DP-06 method. Used to measure the three-dimensional shape and angle of the spray plume, assisting in the analysis of the focusing or diverging behavior of the spray (Note: This manual mainly uses the spray area and morphological characteristics to comprehensively reflect geometric changes).

[0228] In some embodiments, in order to verify the structural reliability of the drug delivery device using the split-type dispensing device described in this application during actual use, especially to verify whether the junction between the separable injector and the valve stem of the canister can maintain stable dose delivery performance under multiple triggering conditions, this application conducted comparative tests on delivered dose uniformity (DDU).

[0229] In this embodiment, the DDU test is performed according to the TM-GW012-DP-02 method, and the main testing instruments used include a Copley Anderson cascade impactor (ACI) and an Agilent high-performance liquid chromatograph (Agilent 1260). As a comparative example, a commercially available conventional integrated metered-dose aerosol device (MDI, model Redihaler, sample number 26073B) is selected. As an example, the split-type dispensing device described in this application is selected, and based on the same main housing, detachable injectors with different material properties and different nozzle structures are assembled to form multiple split-type embodiments. These split-type embodiments include, but are not limited to:

[0230] An example of assembling a standard single-hole injector (sample number POC2-SZ01);

[0231] Example of assembling a soft mist nozzle injector (sample number POC2-SZ02);

[0232] An embodiment of a dual-orifice injector (sample number POC2-SZ05); and

[0233] Example of assembling a converging orifice injector (sample number POC2-SZ08).

[0234] The distribution of delivery dose uniformity (DDU) data obtained from the experiment and the correlation data between delivery dose and spray weight are summarized in Table 2 below. It should be noted that because differences in the geometry of the internal flow channel of the nozzle can affect the unit spray volume, this embodiment does not use the absolute value of the delivery dose as the sole evaluation indicator, but focuses on the stability and dispersion of the dose distribution of each sample under multiple triggering conditions. Table 2 is as follows:

[0235] Please see Figure 45 The figure shows a box plot of the delivery dose uniformity (DDU) obtained in an experiment according to this application. As shown, the dose distribution of the comparative example device (26073B) and several separate embodiments (POC2 series) under multiple triggering conditions is compared. Figure 45 As shown in the box plots of the different samples, the box height (representing the interquartile range of the data) and distribution range of each split-type embodiment are basically consistent with those of the integrated embodiment, with no obvious diffusion or outliers. This indicates that even with different materials and nozzle structures, the split-type injector can maintain good mechanical stability in its engagement with the valve stem within the confined space, without significant dose fluctuations introduced by the disassembly and assembly structure.

[0236] It should be noted that, as Figure 45As shown, apart from the embodiments listed in Table 2, the other split-type injectors with different nozzle structures (such as sample numbers POC2-SZ03, POC2-SZ04, POC2-SZ06 and POC2-SZ07) also showed similar data distribution trends in terms of delivery dose uniformity, and no abnormal dispersion was observed due to the split structure or nozzle differences.

[0237] Please see Figure 46 The graph shows the correlation analysis results between shot weight and delivered dose (DDU) obtained in an experiment according to this application. Figure 46 The scatter plot showing spray weight versus delivery dose indicates that the test data points for both the comparative device and each split-type embodiment are distributed within the same linear trend band. Statistical analysis results show a significant positive linear correlation between delivery dose and spray weight (P = 0.02). This result strongly suggests that, under the split-type structure, the mass of the drug released from the canister valve can be effectively converted into the delivery dose, and the linear correspondence between the two excludes the possibility of structural leakage (if leakage exists, high spray weight cannot be stably converted into high delivery dose, causing the data points to deviate from the linear regression line). Therefore, no significant drug leakage or pressure loss occurred due to the separable fit between the injector and the main shell.

[0238] In summary, the dose delivery uniformity test confirmed that, under multiple triggering and different injector configurations, the split-type dispensing device described in this application is comparable to commercially available integrated devices in terms of dose delivery stability. This indicates that the combination structure of the limiting space and the separable injector can meet the requirements of the drug delivery device for airtightness and structural reliability.

[0239] To verify the technical effect of the split-type distribution device described in this application in terms of heat transfer control through material selection and structural design, especially to verify whether the heat insulation structure formed by the synergistic effect of low thermal conductivity materials and thermal barrier gaps can effectively reduce the initial velocity of the spray plume and thus form a low-speed soft mist, this application further conducted comparative tests on the spray plume velocity under different device configurations.

[0240] This test was conducted according to the TM-GW013-DP-13 standard, and the main testing instruments used included the Spray VIEW spray pattern analyzer and spray morphology analyzer from Proveris. This test focuses on the plume front velocity in the initial stage of spraying, as this indicator directly reflects the intensity of the propellant vaporization process and the magnitude of the ejection kinetic energy, and is a key parameter for evaluating soft fog characteristics.

[0241] Please see Figure 47The figure shows a box plot of the fog cloud leading edge velocity obtained experimentally in this application. The figure compares the comparative example device (26073B) with several modular embodiments (POC2 series). Based on Figure 47 The data distribution and velocity characteristics of each sample are summarized in Table 3 below (Table 3 is a summary of the velocity test results at the leading edge of the fog cloud):

[0242] Note: The high flow rates of samples POC2-SZ05 and POC2-SZ07 in Table 3 indicate that the split structure has a wide range of parameter adjustment capabilities, and the flow rate can be adjusted to different ranges by changing the nozzle array.

[0243] Comparing the sample numbered POC2-SZ01 (split resin, mean ~1.8 mm / ms) in the comparative examples and the sample numbered 26073B (one-piece plastic, mean ~3.6 mm / ms) in the comparative examples, it can be found that, with similar nozzle geometry parameters in the examples and the comparative examples, the spray velocity of the split device is reduced by approximately 50%. This significant difference strongly demonstrates that the thermal barrier gap formed between the outer wall of the injector and the inner wall of the limiting space plays a crucial role. The air layer introduced between the injector and the main housing in the split structure effectively blocks the rapid transfer of external heat to the propellant, suppresses explosive vaporization, and thus achieves a reduction in spray velocity at the physical structural level.

[0244] like Figure 47 As shown, embodiments employing micro / nano resin materials combined with specific flow channel designs (such as sample numbers POC2-SZ02 and POC2-SZ03) further validated the low-flow-rate characteristics. Among them, POC2-SZ06, although a three-pore design, utilized specific porous fluid interference effects to still control the spray velocity at a low level of approximately 2.5 mm / ms, superior to the single-pore integrated comparative example. Furthermore, the converging orifice design (such as sample number POC2-SZ08), utilizing the turbulent interaction of multiple jets, achieved the lowest spray velocity (~1.7 mm / ms) across the entire group, forming an extremely soft mist. This low-velocity characteristic is significant for reducing inertial impaction of drugs in the throat, increasing lung deposition rate, and reducing oral administration irritation.

[0245] It is worth noting that, Figure 47The porous design in the middle section (such as sample numbers POC2-SZ05 and POC2-SZ07) exhibits a high spray velocity. This indicates that the split-type jet of this application, as an independent module, has an extremely wide range of performance adjustment. By changing the internal microstructure of the jet (such as the number and arrangement of pores), it is possible to generate both ultra-low-velocity soft mist (such as sample number POC2-SZ08) and jets with high kinetic energy (such as sample number POC2-SZ07), thereby flexibly adapting to different drug formulations or clinical needs, demonstrating the platform advantages of the split-type design.

[0246] In summary, the spray velocity test results confirm that the split-type dispensing device described in this application, through the synergistic effect of structural thermal insulation (confirmed by sample number POC2-SZ01) and micro-nano resin flow channel design (confirmed by sample number POC2-SZ08), successfully achieves effective control of the spray plume velocity, particularly possessing the core capability to generate low-velocity soft mist. That is, the split-type dispensing device described in this application, by constructing a thermal barrier structure between the injector and the main housing and using a low thermal conductivity material to manufacture the injector, successfully achieves a significant reduction in spray velocity, forming a soft mist spray characteristic that is beneficial for reducing throat impact and improving drug administration comfort without affecting the uniformity of the delivered dose.

[0247] To further evaluate the transport characteristics and potential lung deposition efficiency of the aerosol generated by the split-type dispensing device described in this application in the human respiratory tract, and in particular to verify whether the jet made of specific materials such as micro-nano resin can optimize the atomization effect by improving the surface quality of the nozzle flow channel, this application conducted a comparative test of aerodynamic particle size distribution (APSD).

[0248] This test was conducted according to the TM-GW012-DP-01 standard, using a Copley Anderson Cascade Impactor (ACI) to collect aerosol particles in stages. Test subjects included a commercially available conventional integrated MDI device (model: Redihaler, sample number: 26073B) as a comparative example, and various split-type dispensing devices (POC2 series) as embodiments. These embodiments were configured with separable jets made of different materials, including plastic jets (POC2-Plastic), metal jets (PA017 & PA022), and resin jets (POC2-SZ01). To ensure the rigor of the comparative test, all split-type embodiments and comparative examples (integrated devices) used the same or substantially identical key nozzle dimensional parameters (e.g., nozzle diameter and nozzle length) to eliminate the influence of geometric differences on atomization performance, thus focusing on examining the material properties and the technical effects brought about by the split structure itself.

[0249] The test focuses on the following key aerodynamic indicators: (1) Mass median aerodynamic diameter (MMAD): measures the size of aerosol particles. The smaller the value, the easier it is for the particles to penetrate into the lungs; (2) Geometric standard deviation (GSD): measures the uniformity of particle size distribution. The smaller the value, the more concentrated the particle size distribution; (3) Throat Deposition: measures the unintended retention of drugs in the oropharynx. The lower the value, the better.

[0250] Table 4 below summarizes the typical performance of the comparative example and the separate material examples with the same nozzle size parameters in the APSD test. Table 4 compares the aerodynamic particle size distribution (APSD) test results of the separate dispensing device and the integrated device, as shown in Table 4:

[0251] Please see Figure 48 and Figure 49 , Figure 48 and Figure 49 The sample labeled 26073B (reference preparation) is the commercially available integrated comparative sample selected for this experiment. Figure 48 The MMAD box plots of aerosols generated by different devices are shown. For example... Figure 48 As shown, compared to the integrated comparative example (26073B), all split-type embodiments exhibit a decreasing trend in MMAD. In particular, the embodiments using micro / nano resin (POC2-SZ01) show significantly lower MMAD values ​​and a highly concentrated distribution. This confirms the technical effect described in the claims: the micro / nano resin material, through a high-precision molding process, forms a flow channel geometry without draft angle, effectively reducing frictional resistance and ineffective turbulent dissipation when the liquid flows through the nozzle, thereby promoting fine droplet fragmentation and producing aerosols with smaller particle sizes, more suitable for lung inhalation.

[0252] Figure 49 The distribution curves of drug deposition at various levels of the respiratory tract (from the larynx to deep within the lungs) are shown. Figure 49 As shown in the line graphs of APSD deposition on each electrode, a significant peak in deposition is observed in the simulated throat region, compared to the monolithic comparative model. Figure 49As shown, the curve (26073B) representing the integrated embodiment exhibits a significant peak in the larynx, while the curve representing the split embodiment shows a substantial reduction in deposition at this point, indicating a substantial optimization of drug delivery efficiency. In contrast, all split embodiments show a significant reduction in deposition in the larynx. Combined with the results of the aforementioned spray velocity tests, this is because the low-velocity soft mist effect generated by the split device reduces the inertia of aerosol particles, making them easier to bend with the airflow through the larynx rather than impacting the posterior wall of the larynx. Furthermore, the latter part of the curve shows that the split embodiments maintain a high or comparable drug deposition at the stages representing the deep lungs (Stage 3-Stage 6), demonstrating that the reduced laryngeal deposition has successfully translated into effective lung delivery.

[0253] The combined APSD test results confirm that the split-type dispensing device of this application, particularly the embodiment configured with micro / nano resin jets, can produce high-quality aerosols with smaller MMAD and narrower GSD compared to existing integrated devices with the same nozzle size parameters. Simultaneously, thanks to the low flow rate characteristics brought about by the split structure, drug deposition in the throat is significantly reduced, improving the delivery efficiency of drugs into the lungs. This fully demonstrates that this application, through a combination of material optimization and structural separation, achieves synergistic optimization of aerosol atomization quality and deposition behavior without sacrificing delivery dose uniformity, thereby obtaining drug delivery performance superior to existing integrated devices.

[0254] To verify the flexibility of the split-type dispensing device described in this application as a universal drug delivery platform, and in particular to verify whether the spray pattern and dynamic characteristics can be nonlinearly programmed and controlled by changing the number and arrangement of nozzles inside the separable injector through fluid dynamics mechanisms (such as jet impact or turbulent interaction), this application conducted comprehensive performance tests in multiple dimensions, including spray pattern and spray geometry. Among them, the spray geometry test was used to characterize the differences in spray angle and plume diffusion pattern of different injectors, as an auxiliary evaluation index for controlling the spray pattern by nozzle arrangement.

[0255] This test covered key indicators such as spray area, spray velocity, and fine particulate matter (FPM). The main testing instruments used included Proveris' Spray VIEW spray pattern and spray morphology analyzer. The test objects included: a commercially available traditional integrated MDI device (sample number 26073B) as a comparative example; and micro / nano resin jets with different internal flow channel designs assembled on the same main housing, including multi-pore array designs (such as four-pore POC2-SZ07) and converging designs (such as converging-hole POC2-SZ08).

[0256] By summarizing and comparing typical data of the comparative examples and some embodiments with different nozzle structures in terms of spray area, velocity, and fine particle mass, and based on the experimental results and the fact that FPM is the absolute value of fine particle mass, a summary table of the control effect of different nozzle structures on spray performance is made, as shown in Table 5:

[0257] For data analysis on the nonlinear control of porous fluid interactions and surface area, please refer to [link / reference needed]. Figure 50 . Figure 50 A comparative diagram showing the spray area ranking of each split-type embodiment is displayed. For example... Figure 50 The bar graphs showing different sample numbers indicate that, although embodiment POC2-SZ07 uses four jet holes—four times the number of the comparative example (single hole)—the experimental results show that its spray area (~291 mm²) is significantly smaller than that of the comparative example (~429 mm²). This counterintuitive result confirms the turbulent interaction mechanism described in the claims. When multiple jets are ejected in a close arrangement (such as a four-hole array), strong air entrainment and interference occur between adjacent jets, causing the spray plume to contract towards the central axis. This suggests that the split structure of this application allows for focusing of the spray range by increasing the number of holes, rather than simply expanding it.

[0258] For data analysis on the dual improvement of efficacy and comfort caused by convergence structures, please refer to [link / reference needed]. Figure 51 . Figure 51 A comparison chart of fine particle mass (FPM) values ​​from different samples is shown, along with the data from Table 5 above. Figure 51 The FPM bar charts of different samples show the comparison of the converging orifice example (e.g., sample number POC2-SZ08) and the comparative example (sample number 26073B): In terms of improved efficacy, the fine particulate matter (FPM) of sample number POC2-SZ08 reached ~51.2µg, which was better than the ~48.6µg of the comparative example; in terms of improved comfort (soft mist), the spray velocity of sample number POC2-SZ08 decreased to ~1.7mm / ms, which was less than half of the velocity of the comparative example (~3.6mm / ms).

[0259] This demonstrates the technological advantages of this superior combination of high FPM and low flow rate. The collision or turbulent interaction of multiple fluid streams in space significantly dissipates the kinetic energy of the spray plume (thus reducing throat impact) while simultaneously intensifying droplet breakup (thus increasing lung deposition), making it particularly suitable for the drug delivery needs of sensitive populations.

[0260] In summary, direct comparison with the integrated comparative model confirms that the split-type dispensing device of this application possesses an extremely wide performance control range. Whether focused spraying (such as POC2-SZ07, with an area smaller than the comparative model) or wide-angle soft mist (such as POC2-SZ08, with an area larger than the comparative model and an extremely low flow rate) is required, it can be achieved by simply replacing the spray body with one of different internal structures. This platform capability solves the design rigidity problem of traditional integrated molds. The above results further verify that the technical solution of controlling the spray pattern by changing the number and arrangement of nozzles through replacing the spray body is repeatable and engineering feasible.

[0261] Based on the aforementioned multi-dimensional experimental data and comparative analysis, the split-type dispensing device described in this application has been proven to be more than just an improvement in manufacturing process (i.e., solving the problem of difficult adjustment of integrated molds). More importantly, through the synergistic optimization of structure, materials, and fluid dynamics, it achieves drug delivery performance significantly superior to existing technologies. Experiments have confirmed that the unique split-type assembly structure of this application creates a thermal barrier gap between the injector and the main shell. This gap, together with the selected low thermal conductivity materials (such as micro / nano resins), effectively blocks the rapid transfer of external heat to the propellant, suppressing explosive vaporization at the moment of injection. This thermodynamic mechanism directly translates into a significantly reduced spray plume velocity, thereby solving the industry pain point of excessively high spray speed leading to large throat impact in traditional integrated devices.

[0262] Furthermore, APSD testing revealed that, based on the unique molding process of the micro / nano resin material, the internal flow channel of the jet achieved a high-precision nozzle internal flow channel structure. This materials science optimization reduced frictional resistance and ineffective turbulent dissipation at the microscopic level, enabling the drug solution to be broken down into finer droplets more efficiently. Data showed that this design achieved a smaller median mass aerodynamic diameter (MMAD) and a narrower gross size distribution (GSD), and significantly reduced unintended drug deposition in the throat, improving lung delivery efficiency.

[0263] Furthermore, the porous and converging orifice tests revealed the significant potential of the split structure in hydrodynamic optimization. By altering the orifice arrangement of the separable jet, this application successfully achieved nonlinear programming control of the spray area and morphology using turbulent interactions and spatial impact mechanisms between jets. This allows the same main shell platform to flexibly adapt to various clinical needs, ranging from high-energy focused jets to ultra-low-velocity wide-angle soft mists.

[0264] In summary, the technical solution of this application overcomes the technical defects of traditional integrated devices in terms of rigid design, excessively fast spray speed, and high throat deposition by combining separable structure, micro-nano material properties, and precision flow channel design, while ensuring dosage accuracy and structural airtightness.

[0265] The above embodiments are merely illustrative of the inventive essence and beneficial effects of this application, and are not intended to limit this application. Any person skilled in the art can modify or alter the above embodiments without departing from the principles and scope of this application. Therefore, all equivalent modifications or alterations achieved by those skilled in the art without departing from the spirit and technical concept disclosed in this application should still be covered by the claims of this application.

Claims

1. A dispensing device, characterized in that, include: The main housing includes a chamber for configuring a can, the chamber forming a limiting space; wherein the can includes a valve stem for dispensing a solution stored therein; A jet, detachably disposed in the limiting space, is inserted by the valve stem when the can is placed in the chamber for spraying the solution dispensed by the valve stem.

2. The dispensing device according to claim 1, characterized in that, The ejector includes: The joint includes a mating hole for the valve stem to extend into, and the bottom of the mating hole has a support portion to support the valve stem; The spraying section includes a nozzle for spraying the solution and a connecting section connecting the mating hole and the nozzle.

3. The dispensing device according to claim 2, characterized in that, The inner wall of the mating hole is provided with a locking structure to fix the valve stem.

4. The dispensing device according to claim 2, characterized in that, The nozzle includes at least one injection hole, which has a regular or irregular opening shape.

5. The dispensing device according to claim 4, characterized in that, The nozzle includes two or more independent spray holes; the arrangement of the two or more independent spray holes is configured to adjust the total spray area and spray velocity through the interaction of the fluids ejected from each spray hole.

6. The dispensing device according to claim 5, characterized in that, The plurality of independent injection holes are arranged in an array, and the spacing between the injection holes is configured such that the fluid jets ejected from adjacent injection holes are entrained or contracted toward the center.

7. The dispensing device according to claim 4, characterized in that, The opening shape of the injection hole is circular, square, or triangular.

8. The dispensing device according to claim 1, characterized in that, The limiting space includes a first opening for the ejector to enter or exit and a second opening for the ejector to spray solution.

9. The dispensing device according to claim 8, characterized in that, The restricted space also includes a clearance passage for the ejector to pass through when entering or leaving the restricted space.

10. The dispensing device according to claim 9, characterized in that, The clearance passage is configured to extend from the first opening to the second opening.

11. The dispensing device according to claim 8, characterized in that, The chamber includes a receiving port for receiving the canister, and a first opening is provided corresponding to the receiving port such that the jet conforms to the receiving port and the first opening and is disposed in the confined space.

12. The dispensing device according to claim 1, characterized in that, The jet is provided with a first limiting mechanism, and a first cooperating mechanism is provided in the limiting space to cooperate with the first limiting mechanism to restrict the movement of the jet on the horizontal plane.

13. The dispensing device according to claim 12, characterized in that, The jet body is also equipped with a second limiting mechanism, and a second cooperating mechanism is arranged in the limiting space to cooperate with the second limiting mechanism to restrict the axial movement of the jet body.

14. The dispensing device according to claim 1, characterized in that, The main housing is configured to use a first material, and the ejector is made of a second material with different properties from the first material.

15. The dispensing device according to claim 14, characterized in that, The first material is configured as ABS material, and the second material is configured as PP material, resin material, metal, or ceramic.

16. The dispensing device according to claim 15, characterized in that, The second material is configured as a micro / nano resin; and the thermal conductivity of the second material is lower than that of the first material; when the jet is disposed in the main housing, a thermal barrier gap is formed between the outer wall of the jet and the limiting space, and the micro / nano resin material and the thermal barrier gap are configured together to affect the heat transfer characteristics from the main housing to the interior of the jet to reduce the jet plume velocity.

17. The dispensing device according to claim 15, characterized in that, The second material is configured as a micro / nano resin, and the jet is an integrally molded part based on the micro / nano resin; the jet orifice of the jet has a flow channel geometry without a draft angle, and the flow channel geometry is configured to provide uniform fluid shear force to generate a jet plume in the form of a soft mist.

18. The dispensing device according to claim 15, characterized in that, The second material is configured as a photosensitive resin or a micro / nano resin; the jet is an integrally molded part based on the second material, and the nozzle channel of the jet has a microscopic surface structure defined by the second material, the microscopic surface structure being configured to regulate the flow state of the solution as it flows through the nozzle channel to form a low-speed soft mist.

19. The dispensing device according to claim 1, characterized in that, It also includes an upper housing, on which a first engaging structure is disposed, and a main housing is disposed with a second engaging structure to engage with the first engaging structure to position the upper housing when the upper housing is attached to the main housing.

20. The dispensing device according to claim 1, characterized in that, The dispensing device is configured to drive the tank to dispense the solution stored within it based on a trigger operation.

21. The dispensing device according to claim 20, characterized in that, The triggering operations include manual triggering, breathing triggering, and electronic triggering.

22. The dispensing device according to claim 1, characterized in that, When the injector is positioned in the limiting space of the main housing, a thermal barrier gap is formed between the outer wall of the injector and the inner wall of the limiting space.

23. The dispensing device according to claim 1, characterized in that, The nozzle includes a plurality of converging injection holes, which are configured to cause the fluid jets ejected from each injection hole to collide or interact turbulently in space to form a low-speed soft mist.

24. The dispensing device according to claim 23, characterized in that, The central axes of the plurality of injection holes are inclined inward relative to the injection direction of the injector, such that the fluid jets intersect at a preset distance after leaving the nozzle, the preset distance being configured such that fluid impact occurs in the external space of the injector.

25. A drug delivery device, characterized in that, Includes the dispensing device as described in any one of claims 1 to 24.

26. The drug delivery device according to claim 25, characterized in that, The drug delivery device is configured to drive the solution stored in the tank of the dispensing device based on a trigger operation.

27. The drug delivery device according to claim 26, characterized in that, The triggering operations include manual triggering, breathing triggering, and electronic triggering.

28. The drug delivery device according to claim 25, characterized in that, The drug delivery device is configured as an inhaler.

29. The drug delivery device according to claim 28, characterized in that, The inhaler is a respiratory-actuated inhaler.

30. The drug delivery device according to claim 29, characterized in that, The drug delivery device further includes: A force-holding unit is attached to the main housing of the dispensing device and engages with the can to activate the can in response to a user inhaling air into the dispensing device; A bracket is connected to the force-holding unit to position the force-holding unit.

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