Dose counter subassembly suitable for dry powder inhaler

Abstract

An inhaler device for delivering a dry powder medicament from at least one blister band. The inhaler device includes an actuator for operating a dispensing mechanism of the inhaler device. A dose counter subassembly for use with an inhaler device includes a first counter wheel and a second counter component. The first counter wheel and the second counter component collectively display the number of doses remaining within the inhaler device or the number of doses delivered by the inhaler device. The first counter wheel is configured to be rotated by the dispensing mechanism, and the second counter member is driven by the first counter wheel. And when the first counting wheel rotates for one circle, the second counting component intermittently rotates or translates for one time.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of U.S. Provisional Patent Application No. 63 / 483,393, filed February 6, 2023, which is incorporated herein by reference in its entirety. Technical Field

[0002] The present invention relates generally to an inhaler device and, more particularly, to a dose counter mechanism or dose counter subassembly suitable for use in an inhaler device configured to dispense dry powder medicament from one or more blister strips. Background Art

[0003] A dry powder inhaler (DPI) device can be used to deliver medication to a patient for inhalation. This device is commonly used to treat and prevent respiratory diseases, including but not limited to asthma and chronic obstructive pulmonary disease (COPD). A DPI device can include a blister strip containing multiple independent doses of powdered medication. This device typically includes a mechanism, such as a puncture device, for obtaining a medication dose by opening one or more blister cavities. The user can then obtain the powdered medication through the device and inhale through the device.

[0004] The present invention relates to a device for advancing the drug dosage of the device, and also relates to a counting mechanism for displaying the remaining dosage quantity in the inhaler device. Summary of the Invention

[0005] According to a first embodiment of the present invention, the disclosure provides a kind of Diskus device, it comprises the actuator of the dispensing mechanism that is used to operate Diskus device, the first count wheel that is configured to be rotated by the dispensing mechanism, and the second count unit that is provided with the outer circumferential surface or the outer circumferential side of adjacent first count wheel.The first count wheel comprises a single tooth that extends radially outward on the outer circumferential surface or the outer circumferential side of the first count wheel.The second count unit comprises a plurality of notches on the outer surface or the outer side of the second count unit, each notch extends radially inward, and each notch is configured to cooperate with the single tooth.The single tooth of the first count wheel meshes once with a notch in the plurality of notches of the second count unit when the first count wheel makes one revolution, and to rotate the second count unit intermittently, the first count wheel and the second count unit are configured to rotate in opposite directions.The first count wheel and the second count unit jointly display the number of doses remaining in the inhaler device or the number of doses delivered by the inhaler device.

[0006] In one aspect of the first embodiment, and in combination with any other aspect herein, the present disclosure provides that the actuator is a mouthpiece cover.

[0007] In one aspect of the first embodiment, and in combination with any other aspect herein, the present disclosure provides that the first count wheel rotates about a first axis and the second count member rotates about a second axis, the second axis being parallel to and spaced from the first axis.

[0008] In one aspect of the first embodiment, and in combination with any other aspect herein, the present disclosure provides that the plurality of notches includes four notches.

[0009] In one aspect of the first embodiment, and in combination with any other aspect herein, the present disclosure provides that a segment of an outer surface or outer side surface of the second counting member extending between two adjacent notches of the plurality of notches is concave and forms an arcuate notch that matches the outer circumferential surface or outer circumferential side surface of the first counting wheel.

[0010] In one aspect of the first embodiment, which may be combined with any other aspect herein, the present disclosure provides that the outer surface or side surface of the second counter member includes a plurality of segments, each segment extending between two adjacent notches of the plurality of notches. Each segment is concave and forms an arcuate notch that aligns with the outer circumferential surface or side surface of the first count wheel.

[0011] In one aspect of the first embodiment, and in combination with any other aspect herein, the present disclosure provides that the first count wheel is an annular member.

[0012] In one aspect of the first embodiment, and in combination with any other aspect herein, the present disclosure provides that the second counter component is a non-annular component.

[0013] In one aspect of the first embodiment, and in combination with any other aspect herein, the present invention provides that the marking display surface of the first count wheel includes a "units" digit disposed thereon, and the marking display surface of the second count wheel includes a "tens" digit disposed thereon.

[0014] In one aspect of the first embodiment, and in combination with any other aspect herein, the present invention provides that the indicia display surface of the first count wheel and the indicia display surface of the second count member lie in the same plane.

[0015] In one aspect of the first embodiment, and in combination with any other aspect herein, the present disclosure provides that the indicia display surface of the first count wheel and the indicia display surface of the second count member are not located in the same plane, the indicia display surface of the second count member being closer to the display window of the inhaler device than the indicia display surface of the first count wheel.

[0016] In one aspect of the first embodiment, and in combination with any other aspect herein, the present disclosure provides that the second count member is configured to rotate in a first direction, and the first count wheel is configured to rotate in a second, opposite direction.

[0017] In one aspect of the first embodiment, and in combination with any other aspect herein, the present disclosure provides that the second counting portion includes a single symbol in place of the number zero, the single symbol being a colored block without a number thereon.

[0018] In one aspect of the first embodiment, and in combination with any other aspect herein, the present disclosure provides that the second counting portion includes a double marking, the double marking being a colored block without numbers thereon, the double marking being configured to cover the numbers of the first counting wheel when there are no doses remaining in the inhaler device.

[0019] In one aspect of the first embodiment, and in combination with any other aspect herein, the present disclosure provides that the outer circumferential surface or outer circumferential side of the first count wheel is generally circular with gaps provided around individual teeth.

[0020] In one aspect of the first embodiment, and in combination with any other aspect herein, the present disclosure provides that the second counter member is at rest when a single tooth of the first count wheel is not engaged within one of the plurality of notches of the second counter member.

[0021] In one aspect of a first embodiment, which may be combined with any other aspect herein, the present disclosure provides a first count wheel comprising a detent wheel having a plurality of notches. The dry powder inhaler device further comprises a housing and a flexible arm extending from the housing, the flexible arm comprising a detent configured to be received within one of the plurality of notches of the first count wheel.

[0022] In one aspect of a first embodiment, and in combination with any other aspect herein, the present disclosure provides a flexible arm configured to drive a first count wheel and secure the first count wheel in a target position.

[0023] In one aspect of the first embodiment, and in combination with any other aspect herein, the present disclosure provides a dry powder inhaler device further comprising a housing and a flexible arm extending from the housing, the flexible arm comprising a locating member configured to be received within one of the plurality of notches of the second counter component.

[0024] According to a second embodiment of the present invention, the present disclosure provides a dry powder inhaler device, which includes an actuator for operating a dispensing mechanism of the dry powder inhaler device, a first count wheel configured to be rotated by the dispensing mechanism, and a second count component disposed adjacent to the first count wheel. The first count wheel includes a single tooth extending radially outward from a circumferential surface or circumferential side of the first count wheel. The second count component includes a plurality of rack teeth on an outer surface or outer side of the second count component, the plurality of rack teeth being longitudinally aligned and extending outward in a direction toward the single tooth of the first count wheel. Each time the first count wheel makes a full revolution, the single tooth of the first count wheel engages with one of the plurality of rack teeth of the second count component to intermittently drive the second count component to translate. The first count wheel and the second count component together display the number of doses remaining in the inhaler device or the number of doses delivered by the inhaler device.

[0025] In an aspect of the second embodiment, and in combination with any other aspect herein, the present disclosure provides that the actuator is a mouthpiece cover.

[0026] In an aspect of a second embodiment, and in combination with any other aspect herein, the present disclosure provides that the plurality of rack teeth includes four rack teeth.

[0027] In one aspect of the second embodiment, and in combination with any other aspect herein, the present disclosure provides for the first count wheel to rotate about a first axis of the first count wheel, and for the second count member to translate axially along a longitudinally extending axis of the inhaler device.

[0028] In an aspect of the second embodiment, and in combination with any other aspect herein, the present disclosure provides that the longitudinally extending axis of the inhaler device and the first axis are laterally spaced from each other.

[0029] In one aspect of the second embodiment, and in combination with any other aspect herein, the present disclosure provides that the first count wheel is an annular member.

[0030] In one aspect of the second embodiment, and in combination with any other aspect herein, the present disclosure provides that the second counter component is a non-annular component.

[0031] In one aspect of the second embodiment, and in combination with any other aspect herein, the present invention provides that the marking display surface of the first count wheel includes a "units" digit disposed thereon, and the marking display surface of the second count wheel includes a "tens" digit disposed thereon.

[0032] In one aspect of a second embodiment, and in combination with any other aspect herein, the present disclosure provides that the indicia display surface of the first count wheel and the indicia display surface of the second count member are not located in the same plane, the indicia display surface of the second count member being closer to the display window of the inhaler device than the indicia display surface of the first count wheel.

[0033] In one aspect of the second embodiment, and in combination with any other aspects herein, the present disclosure provides that the second counting portion includes a single indicium in place of the number zero, the single indicium being a colored block without a number thereon.

[0034] In one aspect of a second embodiment, and in combination with any other aspect herein, the present disclosure provides that the second counting portion includes a double marking, the double marking being a colored block without numbers thereon, the double marking being configured to cover the units digit of the first counting wheel when there are no doses remaining in the inhaler device.

[0035] In one aspect of the second embodiment, and in combination with any other aspect herein, the present disclosure provides that the second counting component is in a stationary state when the single tooth is not engaged within one of the plurality of rack teeth.

[0036] In one aspect of the second embodiment, and in combination with any other aspect herein, the present disclosure provides that the second counter component includes a plurality of notches.

[0037] In one aspect of a second embodiment, which may be combined with any other aspect herein, the present disclosure provides a first count wheel and a second count member disposed within a housing of a dry powder inhaler device. The housing includes a flexible arm extending from an inner surface of the housing, the flexible arm including a locating member thereon, the locating member being configured to be received within one of a plurality of notches in the second count member.

[0038] In one aspect of the second embodiment, and in combination with any other aspect herein, the present disclosure provides that the outer surface or outer side of the second counting component including the plurality of rack teeth is a first outer surface or first outer side, and the plurality of notches are provided on a second outer surface or second outer side opposite to the first outer surface or first outer side.

[0039] In one aspect of the second embodiment, and in combination with any other aspect herein, the present disclosure provides that the circumferential surface or circumferential side of the first count wheel is an outer circumferential surface or outer circumferential side.

[0040] In one aspect of the second embodiment, and in combination with any other aspect herein, the present disclosure provides that the circumferential surface or circumferential side of the first count wheel is an inner circumferential surface or inner circumferential side.

[0041] According to a third embodiment of the present invention, the disclosure provides a kind of Diskus device, it comprises the actuator of the dispensing mechanism that is used to operate Diskus device, the first count wheel that is configured to be rotated by the dispensing mechanism, and the second count unit that is at least partially arranged in the first count wheel.The first count wheel comprises a single tooth that extends radially inward from the inner circumferential surface or the inner circumferential side of the first count wheel.The second count unit comprises a plurality of gear teeth on the outer circumferential surface or the outer circumferential side, each gear tooth extends radially outward, and the second count unit is not coaxial with the first count wheel.When the first count wheel rotates once, the single tooth of the first count wheel indirectly or directly engages one of the plurality of gear teeth of the second count unit once, to rotate the second count unit intermittently.The first count wheel and the second count unit jointly display the number of doses remaining in the inhaler device or the number of doses delivered by the inhaler device.

[0042] In an aspect of the third embodiment, and in combination with any other aspect herein, the present disclosure provides that the actuator is a mouthpiece cover.

[0043] In one aspect of the third embodiment, and in combination with any other aspect herein, the present disclosure provides that the first counting wheel rotates about a first axis, and the second counting member rotates about a second axis, the second axis being parallel to and spaced apart from the first axis.

[0044] In one aspect of the third embodiment, and in combination with any other aspect herein, the present disclosure provides that the first count wheel is an annular member.

[0045] In one aspect of the third embodiment, and in combination with any other aspect herein, the present invention provides that the marking display surface of the first count wheel includes a "units" digit disposed thereon, and the marking display surface of the second count wheel includes a "tens" digit disposed thereon.

[0046] In one aspect of a third embodiment, and in combination with any other aspect herein, the present disclosure provides that the indicia display surface of the first count wheel and the indicia display surface of the second count member are not located in the same plane, the indicia display surface of the second count member being closer to the display window of the inhaler device than the indicia display surface of the first count wheel.

[0047] In one aspect of the third embodiment, and in combination with any other aspects herein, the present disclosure provides that the second counting portion includes a single indicium in place of the number zero, the single indicium being a colored block without a number thereon.

[0048] In one aspect of a third embodiment, which may be combined with any other aspect herein, the present disclosure provides that the second counting portion includes a double marking, the double marking being a colored block without numbers thereon, the double marking being configured to cover a units digit of the first count wheel when no dose is remaining in the inhaler device.

[0049] In one aspect of the third embodiment, and in combination with any other aspect herein, the present disclosure provides that the second counting member is in a stationary state when the single tooth is not engaged with one of the plurality of gear teeth of the second counting member.

[0050] In one aspect of the third embodiment, and in combination with any other aspect herein, the present disclosure provides that a single tooth of the first count wheel directly engages a plurality of gear teeth of the second count member.The first count wheel and the second count member are configured to rotate in the same direction.

[0051] In one aspect of a third embodiment, and in combination with any other aspect herein, the present disclosure provides a dry powder inhaler device further comprising an intermediate gear disposed between an inner circumferential surface or inner circumferential side of a first count wheel and an outer circumferential surface or outer circumferential side of a second count member. A single tooth of the first count wheel directly engages the intermediate gear, and the intermediate gear directly engages a plurality of gear teeth of the second count member. The first count wheel and the second count member are configured to rotate in opposite directions. BRIEF DESCRIPTION OF THE DRAWINGS

[0052] The above features and other advantages of the present invention will be apparent from the following description of various embodiments of the present invention in conjunction with the accompanying drawings. The accompanying drawings are incorporated herein as part of this specification and are provided to further illustrate the principles of the present invention and to enable those skilled in the art to implement and use the invention. These drawings are not drawn to scale.

[0053] Figure 1A is a front view of an inhaler device according to an embodiment of the present invention, wherein the mouthpiece cover of the inhaler device is in a closed position.

[0054] Figure 1B yes Figure 1A A rear view of an inhaler device of FIG. 1 , wherein the mouthpiece cover of the inhaler device is in a closed position.

[0055] Figure 1C yes Figure 1A A front view of an inhaler device of FIG. 1 , wherein the mouthpiece cover of the inhaler device is in an open position.

[0056] Figure 1D Is a curve graph used to show Figure 1A-1C The approximate actuation force profile of an inhaler device and mouthpiece cover is shown (dashed line) and compared with the approximate actuation force profile of an inhaler device in which the dispensing mechanism is not actuated during the initial phase of mouthpiece cover travel (solid line).

[0057] Figure 2 is used for Figure 1A A perspective view of two blister strips within an inhaler device.

[0058] Figure 3A yes Figure 1A , with the mouthpiece cover of the inhaler device in an open position and the housing of the inhaler device removed for illustrative purposes only.

[0059] Figure 3B yes Figure 1A A cross-sectional perspective view of a portion of an inhaler device showing a portion of an inhaler device Figure 1A part of the airflow path of an inhaler device.

[0060] Figure 4 yes Figure 1A A perspective view of a manifold of an inhaler device of FIG. 1 , wherein the manifold is removed from the inhaler device for illustration purposes only.

[0061] Figure 4A It is along Figure 4 A cross-sectional view taken along line AA.

[0062] Figure 5 yes Figure 4 A perspective view of the manifold located at Figure 1A near the air inlet of the housing of the inhaler device.

[0063] Figure 6 yes Figure 1A Another perspective view of a manifold of an inhaler device of FIG, wherein the manifold is removed from the inhaler device for illustration purposes only.

[0064] Figure 7 is a schematic diagram showing the Figure 6 The airflow path of the manifold.

[0065] Figure 8 is a schematic flow chart showing the Figure 6 The airflow path of the manifold.

[0066] Figure 9A yes Figure 1A , with the mouthpiece cover of the inhaler device in an open position and with a portion of the housing of the inhaler device removed for illustrative purposes only.

[0067] Figure 9B yes Figure 1A , with the mouthpiece cover and housing of the inhaler device removed for illustration purposes only.

[0068] Figure 10 yes Figure 1A 2. A front view of a ratchet mechanism of an inhaler device of FIG. 1, wherein the ratchet gear is removed from the inhaler device for illustration purposes only.

[0069] Figure 10A Shown with the mouthpiece cover in the closed position Figure 10 ratchet mechanism.

[0070] Figure 10B Shown with the mouthpiece cover in the open position Figure 10 ratchet mechanism.

[0071] Figure 11 yes Figure 1A A perspective view of a portion of a mouthpiece cover and dispensing subassembly of an inhaler device of FIG. 1 , wherein the mouthpiece cover and dispensing subassembly are removed from the inhaler device for illustration purposes only.

[0072] Figure 12A yes Figure 1A Schematic diagram of a tensioning mechanism of an inhalation device, wherein the tensioning mechanism is shown at the beginning of the service life of the device.

[0073] Figure 12B yes Figure 1A Schematic diagram of a tensioning mechanism of an inhalation device, wherein the tensioning mechanism is shown nearing the end of the useful life of the device.

[0074] Figure 13A yes Figure 1A , wherein the tensioning mechanism is removed from the inhalation device for illustration purposes only.

[0075] Figure 13B yes Figure 13ACross-sectional view of the tensioning mechanism.

[0076] Figure 13C yes Figure 13A Cross-sectional view of the tensioning mechanism.

[0077] Figure 13D yes Figure 13A Exploded perspective view of the base and nut of the tensioning mechanism.

[0078] Figure 13E yes Figure 13A A series of cross-sectional views of the tensioning mechanism of FIG. 1 , illustrating the movement of the nut during operation of the inhalation device.

[0079] Figure 14A yes Figure 1A 1 is a perspective view of a counter subassembly of an inhaler device of FIG. 1 , wherein the counter subassembly is removed from the inhaler device for illustration purposes only.

[0080] Figure 14B yes Figure 14A Front view of the counter subassembly.

[0081] Figure 14C It is along Figure 14B The line CC intercepts Figure 14A Front cutaway view of the counter subassembly.

[0082] Figure 14D It is along Figure 14C The line DD intercepts Figure 14A Front cutaway view of the counter subassembly.

[0083] Figure 15A is a perspective view of a counter subassembly according to another embodiment of the present invention, wherein the counter subassembly is configured for Figure 1A The inhaler device comprises a device comprising: a first embodiment of the invention and a second embodiment of the invention; and wherein the counter subassembly indicates 21 doses remaining.

[0084] Figure 15B yes Figure 15A Another perspective view of the counter subassembly of FIG. 1 , wherein the counter subassembly shows zero doses remaining.

[0085] Figure 16A is a front view of a counter subassembly according to another embodiment of the present invention, wherein the counter subassembly is configured for Figure 1A An inhaler device of claim 1, wherein the counter subassembly indicates 26 doses remaining.

[0086] Figure 16B It is along Figure 16A The line BB intercepts Figure 16A Front cutaway view of the counter subassembly.

[0087] Figure 17 is a front view of a counter subassembly according to another embodiment of the present invention, wherein the counter subassembly is configured for Figure 1A An inhaler device of claim 1, wherein the counter subassembly indicates 26 doses remaining.

[0088] Figure 18A is a front view of a counter subassembly according to another embodiment of the present invention, wherein the counter subassembly is configured for Figure 1A The inhaler device comprises a device comprising: a first embodiment of the invention; and wherein the counter subassembly indicates 27 doses remaining.

[0089] Figure 18B It is along Figure 18A The line BB intercepts Figure 18A Front cutaway view of the counter subassembly.

[0090] Figure 19A is a front view of a counter subassembly according to another embodiment of the present invention, wherein the counter subassembly is configured for Figure 1A An inhaler device of claim 1, wherein the counter subassembly indicates 26 doses remaining.

[0091] Figure 19B It is along Figure 19A The line BB intercepts Figure 19A Front cutaway view of the counter subassembly.

[0092] Figure 20A is a front view of a counter subassembly according to another embodiment of the present invention, wherein the counter subassembly is configured for Figure 1A An inhaler device of claim 1, wherein the counter subassembly indicates 30 doses remaining.

[0093] Figure 20B yes Figure 20A Exploded front view of the counter subassembly.

[0094] Figure 20C yes Figure 20A Front view of the first count wheel, second count wheel and transmission gear of the counter subassembly.

[0095] Figure 20D yes Figure 20A A partial perspective view of the counter subassembly.

[0096] Figure 20E yes Figure 20A Schematic cross-sectional view of the lens of the counter subassembly.

[0097] Figure 20F yes Figure 20A A partial perspective view of the counter subassembly, and Figure 1AA first bottom sheet winding gear in an inhaler device.

[0098] Figure 20G yes Figure 20F An enlarged perspective view of the first bottom sheet winding gear.

[0099] Figure 20H yes Figure 20F An enlarged perspective bottom view of the transmission gear.

[0100] Figure 20I yes Figure 20A Cross-sectional view of the front step of the counter subassembly.

[0101] Figure 20J yes Figure 20A Front view of the backplate of the counter subassembly.

[0102] Figure 20K yes Figure 20A Rear view of the first count wheel of the counter subassembly.

[0103] Figure 20L Is set in Figure 20J Inside the back panel Figure 20A A cross-sectional view of a first count wheel of a counter subassembly with the first flexible arm in a first position.

[0104] Figure 20M Is set in Figure 20J Inside the back panel Figure 20A A cross-sectional view of a first count wheel of a counter subassembly with the first flexible arm in a second position. DETAILED DESCRIPTION

[0105] The specific embodiment of the present invention is now described with reference to the accompanying drawings, wherein identical reference numerals represent identical or functionally similar elements. Following specific embodiment is merely exemplary in nature, is not intended to limit the present invention or application and purposes of the present invention. Although description of the present invention is carried out under the background of Diskus device, the present invention also can be used for other applications that are considered to be useful. In addition, for any theory of express or implication proposed in aforementioned technical field, background technology, summary of the invention or following specific embodiment, it is not intended that the present invention be construed therein.

[0106] Embodiments of the present invention relate to an inhaler device configured to deliver powdered medicament from at least one blister strip. More specifically, embodiments of the present invention relate to a counter mechanism for displaying the number of doses remaining in the inhaler device. The counter mechanism described herein is illustrated in an inhaler device configured to deliver powdered medicament from two blister strips simultaneously, but the tensioning mechanism can also be applied to inhaler devices that deliver powdered medicament from a single blister strip or from more than two blister strips.

[0107] Figure 1A 、 Figure 1B and Figure 1C An inhaler device 100 according to an embodiment thereof is shown. The inhaler device 100 includes a housing 102 and a mouthpiece cover 108. The housing 102 includes a display window 104 through which a number is displayed indicating the number of remaining doses of the inhaler device 100. The housing 102 also includes a plurality of openings or air inlets 106 formed through the sidewalls of the housing 102. As will be described in more detail herein, when a user inhales at the mouthpiece 110, air from outside the inhaler device 100 is drawn into the interior of the inhaler device 100 via the air inlets 106. Figure 1A and Figure 1B In FIG, the mouthpiece cover 108 of the inhaler device 100 is in a closed position, wherein the mouthpiece cover 108 covers or extends over the mouthpiece 110. Figure 1C In the embodiment of the present invention, the mouthpiece cover 108 is in the open position, so that the mouthpiece 110 is exposed and accessible to the user. Only when the mouthpiece cover 108 is in the open configuration can the user inhale the powdered medicament through the mouthpiece 110. The mouthpiece 110 includes a central outlet or opening 112 that allows the powdered medicament contained in the inhaler device 100 to be delivered to the user through inhalation.

[0108] exist Figure 1A and Figure 1B In the closed position, the mouthpiece 110 and the air inlet 106 are covered by the mouthpiece cover 108. When the user wishes to inhale a dose of medicine from the inhaler device 100, the mouthpiece cover 108 is opened. Figure 1A and Figure 1B The closed position moves to Figure 1CIn the open position, the mouthpiece cover 108 rotates or moves relative to the housing 102 so that the mouthpiece 110 and the air inlet 106 are fully exposed and no longer obstructed by any part of the mouthpiece cover 108. Since the instructions for use require the user to cover the central opening 112 of the mouthpiece 110 with their mouth when inhaling powdered medicament, the mouthpiece cover 108 can protect the mouthpiece 110 when the inhaler device 100 is not in use to prevent the airflow channel of the inhaler device 100 from being contaminated by unwanted particles, thereby avoiding adverse effects on the user's experience and / or dose delivery. As will be described in more detail herein, the movement of the mouthpiece cover 108 from the closed position to the open position actuates the dispensing mechanism in the inhaler device 100 to make the medicament dose available for inhalation, and further actuates the counting mechanism in the inhaler device 100 to reduce the number of remaining doses displayed in the display window 104 by one unit. Thus, the mouthpiece cover 108 not only serves to protect the central opening 112 of the mouthpiece 110, but also serves to operate the dispensing mechanism and the counting mechanism of the inhaler device 100. For each dose, the user only needs a single operating step, namely moving the mouthpiece cover 108, to activate the inhalation device 100.

[0109] In one embodiment, the user can rotate mouth cover 108 85 to 105 degrees, to expose mouth cover 110 and air inlet 106. When designing inhaler device 100, it is very important to ensure that the required power of actuating mouth cover 108 is enough little, so that the user with physical ability level can all operate easily. Generally speaking, when the stroke distance of mouth cover 108 is longer, in the dispensing mechanism of inhaler device, realize more favorable mechanical advantage, thereby make for each dosage, rotation mouth cover 108 and the required actuating force of actuating inhaler device 100 are less. Yet, from the perspective of ergonomics, the shorter stroke distance of mouth cover 108 can avoid the user from changing the gripping posture during actuation. The shorter stroke distance of mouth cover 108 also makes housing 102 bigger for the zone that the user holds during actuation, because mouth cover 108 is less through the zone of housing 102. The shorter stroke of the mouthpiece cover 108 also provides more space for other features of the inhaler device 100 and / or allows the size of the inhaler device 100 to be minimized. In one embodiment, a cover stroke between 90 degrees and 100 degrees can provide an optimal balance between the above factors. Figure 1A-1C As shown, the housing 102 includes an integral flange or step 102A formed thereon that controls or limits the rotational movement of the mouthpiece cover 108 to a desired range.

[0110] The force distribution in the stroke of mouthpiece cover 108 will affect the user's experience and the tactile feedback that inhaler device 100 provides. It is also preferred to keep a relatively consistent or constant actuating force in the stroke of mouthpiece cover 108, to avoid incorrect use or confusion. Making the entire stroke of mouthpiece cover 108 all participate in operating the dispensing mechanism, it is expected that the actuating force distribution will be more consistent, and help to alleviate the risk of misusing inhaler device 100. For example, in an inhaler device different from the present invention, the dispensing mechanism is not actuated in the initial stage when the mouthpiece cover moves, so the actuating force in this initial stage can be relatively low. When the dispensing mechanism is actuated, the actuating force of the mouthpiece cover increases. Therefore, in an inhaler different from the present invention, the actuating force of the mouthpiece cover significantly increases midway through the entire stroke of the mouthpiece cover, and the user may mistakenly perceive this change as a tactile feedback that implies that the mouthpiece cover has fully opened to take a dose. In other words, with regard to tactile feedback, a non-constant actuating force distribution may confuse the user and may cause the incorrect use of the device. Figure 1D The approximate actuation force profile of an inhaler device 100 having a mouthpiece cover 108 according to embodiments herein is shown (represented by the dashed line) and compared with the approximate actuation force curve (represented by the solid line) of the inhalation device described in the previous example, which does not actuate the dispensing mechanism during the initial period of the mouthpiece cover stroke. Figure 1D As shown by the solid line in FIG, when the dispensing mechanism is not actuated at the beginning of the mouthpiece stroke, there is a step in the actuation force distribution. Figure 1D As shown by the dashed line in FIG, when the dispensing mechanism is actuated at the beginning of the mouthpiece stroke as in the inhaler device 100, the actuation force is generally constant or consistent and the peak actuation force is lower.

[0111] The inhaler device 100 is configured to dispense dry powder medicament from two blister strips simultaneously. More specifically, referring to Figure 2, shows a first blister strip 160A and a second blister strip 160B. The inhaler device 100 described herein is configured to dispense medicine from each of the first blister strip 160A and the second blister strip 160B simultaneously. Each blister strip 160A, 160B includes a bottom sheet 162A, 162B, respectively, which defines a series or multiple individual blisters or cavities (pockets) 164A, 164B thereon. Each cavity 164A, 164B is configured to contain a dose or a portion of a dose of dry powder or powdered medicine 168A, 168B that will be inhaled by the user. In one embodiment, powdered medicine 168A is a different medicine from powdered medicine 168B, so that the inhaler device 100 is configured to deliver two different powdered medicines to the user simultaneously. Top sheets 166A, 166B are airtightly adhered or sealed to bottom sheets 162A, 162B, respectively, to enclose cavities 164A, 164B, and act as lids for cavities 164A, 164B, respectively, to contain powdered medicament 168A, 168B therein. The airtight seal of top sheets 166A, 166B allows bottom sheets 162A, 162B to be peeled away from top sheets 166A, 166B, thereby opening or exposing cavities 164A, 164B and providing access to powdered medicament 168A, 168B therein. Each of first blister strip 160A and second blister strip 160B is sufficiently flexible to be rolled into a roll.

[0112] As will be described in greater detail herein, when the dispensing mechanism of the inhaler device 100 is actuated by movement of the mouthpiece cover 108, the top sheets 166A, 166B of the blister strips 160A, 160B peel away from the bottom sheets 162A, 162B of the blister strips 160A, 160B, respectively, to open or expose the cavities 164A, 164B of each blister strip, thereby exposing the powdered medicament 168A, 168B disposed in the cavities 164A, 164B. Upon inhaling through the mouthpiece 110, the user simultaneously inhales the powdered medicament 168A, 168B from the opened cavities 164A, 164B of the blister strips 160A, 160B, respectively. Thus, the user receives a fixed metered dose of medicament powder, each dose consisting of a respective dose portion of medicament powder from the opened cavities 164A, 164B of the blister strips 160A, 160B. Each blister strip 160A, 160B may be the same size and / or contain the same dosage (eg, volume or mass) of the powdered medicament, or may be a different size and / or contain a different dosage of the powdered medicament.

[0113] Figure 3AFIG1 is a front view of the inhaler device 100 with the mouthpiece cover 108 in the open position and the housing 102 removed for illustration purposes only. The inhaler device 100 includes a manifold 114 for directing airflow through the manifold 114 to entrain and deliver powdered medicament 168A, 168B from blister strips 160A, 160B, respectively, to a user via the mouthpiece 110. The manifold 114 is in fluid communication with the mouthpiece 110 such that the powdered medicament 168A, 168B can be delivered to the user through the central opening 112 of the mouthpiece 110. In addition to the manifold 114, the inhaler device 100 also includes a dispensing subassembly or mechanism 120, a counter subassembly or mechanism 134, and tensioning subassemblies or mechanisms 151A, 151B. In the assembled state, each of the manifold 114 , the dispensing subassembly 120 , the counter subassembly 134 , and the tensioning mechanisms 151A, 151B are located or disposed within the housing 102 .

[0114] Reference here Figure 3B The operation of the manifold 114 is described. The manifold 114 defines an air path through the inhaler device 100. The manifold 114 fluidly connects the mouthpiece 110 to the first blister strip 160A and the second blister strip 160B. Figure 3B is a cross-sectional view taken along the manifold 114, illustrating the airflow path through the manifold 114 for entraining the medication 168B of the second blister strip 160B. Figure 10 As explained in FIG. 14 , the manifold 114 also defines an airflow path through the manifold 114 for entraining the medication 168A of the first blister strip 160A.

[0115] During use, the user rotates the mouthpiece cover 108 to expose the mouthpiece 110 and the air inlet 106. Inside the inhaler device 100, rotating the mouthpiece cover 108 exposes the powdered medicament 168A, 168B within the cavities 164A, 164B of each of the first and second blister strips 160A, 160B, respectively. To access the powdered medicament 168A, 168B within the opened cavities 164A, 164B, the user exhales or inhales through the mouthpiece 110. The user covers the central opening 112 of the mouthpiece 110 with their mouth and inhales, thereby creating a pressure differential between the air inlet 106 and the central opening 112, causing air to flow through the manifold 114. This pressure differential causes external air (i.e., air from outside the inhaler device 100) to enter the inhaler device 100 through the air inlet 106, pass through the opened cavities 164A, 164B, and exit the inhaler device 100 through the central opening 112. The airflow path defined by the manifold 114 is designed so that when the user inhales, the powdered medicament 168A, 168B exposed in the open cavities 164A, 164B is carried away by the airflow and delivered to the user as an orally inhaled combined medicament dose. In this way, the user can inhale a dose portion from each blister strip 160A, 160B at the same time.

[0116] The manifold 114 is configured to preferentially direct the inhaled airflow in a variety of ways to achieve airflow characteristics that are conducive to the efficient delivery of the powdered medicament. More specifically, as Figure 3B As shown, the geometry of the manifold 114 causes a portion of the inhaled airflow to enter and exit the open cavity 164B (at the Figure 3B The other part of the inhaled airflow passes through the guide structure or hole in the manifold 114 (which is marked with a dotted line 199). Figure 4-Figure 8 ). The portion of the inhaled airflow passing through the open cavity 164B entrains a dose of powdered medicament 168B in the airflow. The portion of the inhaled airflow passing through the flow-guiding structure in the manifold 114 intersects with the entrained airflow portion to break up the powdered medicament therein, and then both flow out of the manifold 114.

[0117] Steering Figure 4-Figure 8, the manifold 114 is described in more detail. The manifold 114 is configured to simultaneously deliver powdered medicaments 168A, 168B from corresponding open blister cavities 164A, 164B of each of the first and second blister strips 160A, 160B, respectively. The manifold 114 includes a body 170 that defines a first space or atrium 172A, a second space or atrium 172B, and a flow stack 180. As will be explained in more detail herein, the separate and distinct chambers or spaces of the first and second atrium 172A, 172B, and flow stack 180 can separate, divert, or otherwise partition an inhaled airflow drawn into the manifold 114 by a user into multiple airflow paths that pass through the body 170 of the manifold 114. More specifically, when an inhalation force is applied through the central opening 112 of the mouthpiece 110, an inhaled airflow is drawn into the first and second vestibular cavities 172A, 172B of the manifold 114 via the air inlet 106 of the inhaler device 100. The first and second vestibular cavities 172A, 172B are positioned adjacent to, or alongside, the air inlet 106. Once the inhaled airflow enters the manifold 1114, as it passes through the main body 170 of the manifold, it splits or forms four airflow paths: a first diverter airflow path 192, a second diverter airflow path 194, a first entrained airflow path 196, and a second entrained airflow path 198. In other words, each of the first diverter airflow path 192, the second diverter airflow path 194, the first entrained airflow path 196, and the second entrained airflow path 198 is a respective airflow portion of the inhaled airflow drawn into the manifold 114.

[0118] In this embodiment, the first vestibule chamber 172A and the second vestibule chamber 172B are disposed laterally adjacent to or side by side with each other on one side of the body 170 of the manifold 114. The first vestibule chamber 172A and the second vestibule chamber 172B are separated from each other by a partition wall 173 such that there is no fluid communication between the first vestibule chamber 172A and the second vestibule chamber 172B. The first vestibule chamber 172A includes a single vestibule chamber inlet 174A, and the second vestibule chamber 172B includes a single vestibule chamber inlet 174B. The vestibule chamber inlets 174A, 174B are separate from each other and may also be considered inlets to the manifold 114. Thus, the manifold 114 includes two inlets, with the vestibule chamber inlet 174A leading to or into the first vestibule chamber 172A and the vestibule chamber inlet 174B leading to or into the second vestibule chamber 172B.

[0119] The first vestibular cavity 172A includes a first vestibular cavity outlet 176A and a second vestibular cavity outlet 178A, and the second vestibular cavity 172B includes a first vestibular cavity outlet 176B and a second vestibular cavity outlet 178B. As will be explained in greater detail herein, the first vestibular cavity outlet 176A, 176B of each of the first and second vestibular cavities 172A, 172B, respectively, directs or guides fluid directly into the flow channel 180, and the second vestibular cavity outlet 178A, 178B of each of the first and second vestibular cavities 172A, 172B, respectively, directs or guides fluid into the open cavities 164A, 164B of the first and second blister strips 160A, 160B, respectively. In one embodiment, the first vestibular cavity outlets 176A, 176B are substantially rectangular or oval in outline or shape. However, the profile or shape of the first vestibular cavity outlet 176A, 176B is not limited to the shapes described herein and may alternatively be circular, triangular, or any other shape deemed suitable for the purposes described herein. Similarly, the profile or shape of the second vestibular cavity outlet 178A, 178B is substantially circular and includes a grille or cross-piece 197 (see FIG. Figure 4 ) to enhance turbulence in the airflow. However, the profile or shape of the second vestibular cavity outlets 178A, 178B is not limited to the shapes described herein, and may alternatively be rectangular, elliptical, oval, triangular, or any other shape deemed suitable for the purposes described herein, and may or may not include a grille across it.

[0120] like Figure 7As best shown, the flow channel 180 is in fluid communication with each of the first vestibule cavity 172A, the second vestibule cavity 172B, the open cavity 164A in the first blister strip 160A, and the open cavity 164B in the second blister strip 160B. The flow channel 180 has four inlets: a first flow channel inlet 182, a second flow channel inlet 184, a third flow channel inlet 186, and a fourth flow channel inlet 188. The first flow channel inlet 182 is aligned with the first vestibule cavity outlet 176A of the first vestibule cavity 172A, placing the flow channel 180 and the first vestibule cavity 172A in fluid communication with each other. The second flow channel inlet 184 is aligned with the open cavity 164A of the first blister strip 160A, placing the second flow channel inlet 184 in fluid communication with the second vestibule cavity outlet 178A of the first vestibule cavity 172A through the open cavity 164A. The third flow channel inlet 186 is in fluid communication with the second vestibule cavity outlet 176B of the second vestibule cavity 172B, thereby placing the flow channel 180 and the second vestibule cavity 172B in fluid communication with each other. The fourth flow channel inlet 188 is in fluid communication with the open cavity 164B of the second blister strip 160B, thereby further placing the fourth flow channel inlet 188 in fluid communication with the second vestibule cavity outlet 178B of the second vestibule cavity 172B through the open cavity 164B.

[0121] The profile or shape of each of the first and third flow channel inlets 182, 186 is substantially rectangular or elliptical. However, the profile or shape of the first and third flow channel inlets 182, 186 are not limited to the shapes described herein and may alternatively be circular, triangular, or any other shape deemed suitable for the purposes described herein. Similarly, the profile or shape of the second and fourth flow channel inlets 184, 188 are substantially circular and include a grille or cross member 195 (see FIG. Figure 4 ) to enhance turbulence in the airflow. However, the profile or shape of the second and fourth flow guide channel inlets 184, 188 is not limited to the shapes described herein and may alternatively be rectangular, elliptical, oval, triangular, or any other shape deemed suitable for the purposes described herein, and may or may not include a grille across it.

[0122] Flow guiding channel 180 is a single flow guiding channel with a single flow guiding channel outlet 190. Therefore, in the present embodiment, flow guiding channel 180 has only a flow guiding channel outlet 190. The flow guiding channel outlet 190 can also be considered to the outlet of manifold 114. Like this, manifold 114 only comprises an outlet. The shape or the outline of flow guiding channel outlet 190 are elliptical. Yet the outline or the shape of flow guiding channel outlet 190 are not limited to shape as herein described, and can alternatively be circle, rectangle, ellipse, triangle or be considered to any other shape that is suitable for purpose as herein described. When manifold 114 was assembled in the inhaler device 100, the flow guiding channel outlet 190 aligned with the central opening 112 of mouthpiece 110 and was communicated with on fluid.

[0123] The second vestibule cavity outlet 178A of the first vestibule cavity 172A is in fluid communication with the second flow channel inlet 184 to define a first entrainment airflow path 196 associated with the open blister cavities 164A of the first blister strip 160A. As the airflow flows through the open blister cavities 164A, the airflow entrains the powdered medicament 168A disposed within the open blister cavities 164A. Thus, by passing through the open blister cavities 164A, the powdered medicament 168A is drawn into and delivered into the flow channel 180 by the airflow. After entrainment, the airflow carries the powdered medicament 168A.

[0124] Similarly, the second vestibule cavity outlet 178B of the second vestibule cavity 172B is in fluid communication with the fourth flow channel inlet 188 to define a second entrainment airflow path 198 associated with the open blister cavities 164B of the second blister strip 160B. As the airflow flows through the open blister cavities 164B, it entrains the powdered medicament 168B disposed within the open blister cavities 164B. Thus, by passing through the open blister cavities 164B, the powdered medicament 168B is drawn in and delivered by the airflow into the flow channel 180. After entrainment, the airflow carries the powdered medicament 168B.

[0125] The first vestibule chamber outlet 176A of the first vestibule chamber 172A is communicated with the first diversion airflow path 192 of the first guiding channel inlet 182 on fluid, to limit the first diversion airflow path 192 of manifold 114.Similarly, the first vestibule chamber outlet 176B of the second vestibule chamber 172B is communicated with the 3rd diversion airflow path 186 on fluid, to limit the second diversion airflow path 194 of manifold 114.Compared with the first entrained airflow path 196 and the second entrained airflow path 198, each diversion airflow path 192,194 is that air flows to the oral cavity of patient from inhaler device 100 outsides and provides the path of lower resistance.Therefore, the total airflow resistance of inhaler device 100 reduces, thereby for can realizing higher overall flow rate under identical suction pressure.In addition, diversion airflow path 192,194 provides the deagglomeration process to powdered medicine 168A, 168B before powdered medicine 168A, 168B leaves manifold 114. Each of first and second diverter airflow paths 192, 194 is configured to disrupt each of first and second entrainment airflow paths 196, 198 and break up the entrained medication. More specifically, first diverter airflow path 192 is directed into the path of first entrainment airflow path 196, which is angled at a different angle from first diverter airflow path 192. This creates a region of higher shear forces at the intersection between first and second diverter airflow paths 192, thereby enhancing the deagglomeration of powdered medication 168A prior to exiting manifold 114. Similarly, second diverter airflow path 194 is directed into the path of second entrainment airflow path 198, which is angled at a different angle from second diverter airflow path 194. An area of ​​higher shear is created at the intersection between the second diverging airflow path 194 and the second entraining airflow path 198, thereby enhancing the deagglomeration of the powdered medicament 168B prior to exiting the manifold 114. The first diverging airflow path 192, the second diverging airflow path 194, the first entraining airflow path 196, and the second entraining airflow path 198 combine or mix together within the flow channel 180 before exiting the manifold 114 together.

[0126] like Figure 8As shown in the flow chart of , the inhaled airflow from the inhaler device 100 outside suction separates between two inlets of manifold 114, promptly separates between the first vestibular cavity entrance 174A and the second vestibular cavity entrance 174B.Therefore, the inhaled airflow from the inhaler device outside suction enters the first vestibular cavity 172A and the second vestibular cavity 172B simultaneously.The first part of the inhaled airflow that enters the first vestibular cavity 172A flows into the blister cavity 164A that opens, and the second part of the inhaled airflow that enters the first vestibular cavity 172A directly flows into the flow guiding channel 180.The first part of the inhaled airflow in the blister cavity 164A that opens carries or carries entrained the powdered medicine 168A that is arranged on the blister cavity 164A that opens, and then continues to enter the flow guiding channel 180.In the flow guiding channel 180, the second part of the inhaled airflow from the first vestibular cavity 172A breaks up or disaggregates the powdered medicine 168A that carries entrained in the first part of the inhaled airflow. Similarly, a first portion of the inhaled airflow entering the second vestibular cavity 172B flows into the open blister cavity 164B, and a second portion of the inhaled airflow entering the second vestibular cavity 172B flows into the flow channel 180. The first portion of the inhaled airflow within the open blister cavity 164B carries or entrains the powdered medicament 168B disposed within the open blister cavity 164B and then continues into the flow channel 180. Within the flow channel 180, the second portion of the inhaled airflow from the second vestibular cavity 170B breaks up or deagglomerates the powdered medicament 168B entrained within the first portion of the inhaled airflow. Within the flow channel 180, all portions of the airflow are mixed together before entering the patient's oral cavity and exiting the manifold 114. The mixed airflow includes both medicament 168A from the first blister strip 160A and medicament 168B from the second blister strip 160B. Airflow through the first vestibule cavity 172A and the open blister cavity 164A occurs simultaneously with airflow through the second vestibule cavity 172B and the open blister cavity 164B.

[0127] Because the first vestibular cavity 172A and the second vestibular cavity 172B are separate and distinct compartments, and the partition wall 173 extends between the first vestibular cavity 172A and the second vestibular cavity 172B, the inhaled airflow entering the manifold 114 is preferentially directed to the outlet of each vestibular cavity. Directing the separated inhaled airflow into the open blister cavities 164A, 164B in this way reduces the turbulent energy in the airflow at this stage and thus reduces the overall airflow resistance of the inhaler device 100. The overall airflow resistance allows the patient to achieve a higher airflow rate at the same inhalation pressure, which can improve the effectiveness of drug delivery.

[0128] Now turn Figure 9A and Figure 9B, describes the dispensing subassembly 120 of the inhaler device 100 in more detail. The dispensing subassembly 120 is configured to advance each blister strip 160A, 160B and open its cavity 164A, 164B each time the user fully opens the mouthpiece cover 108. The first blister strip 160A and the second blister strip 160B are disposed within a first compartment 118A and a second compartment 118B within the housing 102. More specifically, the compartments 118A, 118B are formed by an internal chassis 116 disposed within the housing 102. Via the dispensing subassembly 120, the continuous cavities 164A, 164B of each blister strip 160A, 160B are directed to a manifold 114, which is disposed along the centerline of the inhaler device 100, or approximately along the centerline. When positioned at the manifold 114, the cavity 164A, 164B of each blister strip 160A, 160B has been opened and the powdered medicament 168A, 168B within the opened cavity of each blister strip 160A, 160B is available for inhalation. The empty bottom sheet 162A, 162B and top sheet 166A, 166B of the blister strips 160A, 160B are wound up by the dispensing subassembly 120 as described herein. Figure 9A is a front view of the inhaler device 100 with the mouthpiece cover 108 in an open position and with a front half or portion of the housing 102 of the inhaler device 100 removed for illustration purposes only. Figure 9B is a rear view of the inhaler device 100 with the mouthpiece cover 108 and housing 102 removed for illustration purposes only.

[0129] The dispensing subassembly 120 includes a central drive gear 122, a ratchet mechanism 124, a first idler gear or intermediate gear 126, a second idler gear or intermediate gear 127, a first bottom sheet take-up gear 128A and a second bottom sheet take-up gear 128B, a first index gear 130A and a second index gear 130B, and a first top sheet take-up gear 150A and a second top sheet take-up gear 150B. The first bottom sheet take-up gear 128A, the first index gear 130A, and the first top sheet take-up gear 150A are associated with advancing the first blister strip 160A, while the second bottom sheet take-up gear 128B, the second index gear 130B, and the second top sheet take-up gear 150B are associated with advancing the second blister strip 160B.

[0130] like Figure 11As shown, the first positioning gear 130A and the second positioning gear 130B are attached to or integrally formed with the first positioning reel 131A and the second positioning reel 131B, respectively. Each of the first positioning reel 131A and the second positioning reel 131B includes a pair of grooves 132A and 132B. Each groove in the pair of grooves 132A and 132B is configured to receive a cavity 164A and 164B of a blister strip 160A and 160B, respectively. Rotation of the first positioning gear 130A and the second positioning gear 130B causes the first positioning reel 131A and the second positioning reel 131B to rotate and operate to move the grooves 132A and 132B, respectively, adjacent to or juxtaposed with the manifold 114. As the blister strips 160A, 160B are advanced by the positioning reels 131A, 131B, the top sheets 166A, 166B of the blister strips 160A, 160B are peeled away from the bottom sheets 162A, 162B of the blister strips 160A, 160B, causing the cavities 164A, 164B adjacent the manifold 114 to open and the powdered medicament 168A, 168B in the cavities 164A, 164B to be entrained. More specifically, to expose each dose of powdered medicament 168A, 168B, the top sheets 166A, 166B are peeled away from the bottom sheets 162A, 162B, respectively, causing the cavities 164A, 164B in each bottom sheet 162A, 162B to be opened or exposed. The cavities 164A, 164B are exposed or opened by relative rotation between the positioning reels 131A, 131B and the top sheet take-up gears 150A, 150B. The positioning reels 131A, 131B substantially clamp the bottom sheets 162A, 162B, respectively, while the top sheet take-up gears 150A, 150B substantially clamp the top sheets 166A, 166B, respectively. When the positioning reels 131A, 131B and the top sheet take-up gears 150A, 150B rotate relative to each other, the bottom sheets 162A, 162B and the top sheets 166A, 166B peel away from each other. As will be described in greater detail herein, the positioning reels 131A, 131B and the top sheet take-up gears 150A, 150B are driven to rotate in opposite directions via a gear transmission, such that when the gears are driven, each top sheet 166A, 166B is peeled off from its corresponding bottom sheet 162A, 162B. Thus, the dispensing subassembly 120 opens the corresponding front cavity 164A, 164B and positions it in fluid communication with the manifold 114, making the powdered medicament 168A, 168B of the opened cavity 164A, 164B available for inhalation.

[0131] The first bottom sheet winding gear 128A and the second bottom sheet winding gear 128B are operated to wind up the empty bottom sheets 162A, 162B of the blister strips 160A, 160B, respectively. Figure 11 As shown, the first and second bottom sheet winding gears 128A and 128B are attached to or integrally formed with the main shafts 129A and 129B, respectively. Rotation of the first and second bottom sheet winding gears 128A and 128B causes the first and second main shafts 129A and 129B to rotate therewith and operate to wind the bottom sheets 162A and 162B during operation of the inhaler device 100. The ends of each bottom sheet 162A and 162B are secured to the first and second bottom sheet winding gears 128A and 128B, such that gradual rotation of the first and second bottom sheet winding gears 128A and 128B causes the bottom sheets 162A and 162B to be wound into a tight bundle therearound.

[0132] The first and second top sheet take-up gears 150A, 150B are operated to take up the top sheets 166A, 166B of the blister strips 160A, 160B, respectively. Figure 14A As shown in greater detail in FIG14E , the first and second top sheet winding gears 150A, 150B are coupled to winding hubs 152A, 152B, respectively. Rotation of the first and second top sheet winding gears 150A, 150B causes the first and second winding hubs 152A, 152B to rotate therewith and operate to wind or reel in the top sheets 166A, 166B during operation of the inhaler device 100. The ends of each top sheet 166A, 166B are anchored to the first and second winding hubs 152A, 152B, such that progressive rotation of the first and second top sheet winding gears 150A, 150B causes the top sheets 166A, 166B to be wound into a tight bundle therearound.

[0133] The central drive gear 122 of the dispensing subassembly 120 is attached to the mouthpiece cover 108 via a ratchet mechanism 124. Figure 10 10. The ratchet mechanism 124 removed from the inhaler device 100 is shown in FIG. Ratchet mechanism 124 comprises a pawl 125 attached to the mouth cover 108 and a ratchet 123 integrally formed with or attached to the central drive gear 122. When the mouth cover 108 is opened, the pawl 125 is driven in the second opposite direction together with the mouth cover 108. The pawl 125 then drives the ratchet 123 in the second opposite direction to advance or drive the dispensing subassembly 120. When the mouth cover 108 returns to its closed position, the dispensing subassembly 120 is not advanced or actuated, but remains stationary. Therefore, the opening action of the mouth cover 108 is transmitted to the central drive gear 122, and the closing action of the mouth cover 108 can not be transmitted to the central drive gear 122.

[0134] More specifically, the ratchet 123 includes a plurality of circumferentially spaced inner stop surfaces 123A and outer stop surfaces 123B around its periphery or edge. The pawl 125 includes a plurality of flexible pawl arms 125A configured to interact with the circumferentially spaced inner stop surfaces 123A of the ratchet 123. When the mouth cover 108 moves from the closed first position to the open second position, the pawl 125 rotates in the first direction together with the mouth cover 108. Figure 10B As shown, when rotated in a first direction, pawl arms 125A engage and drive circumferentially spaced inner stop surfaces 123A of ratchet 123, thereby transmitting torque to central drive gear 122. Because ratchet 123 is attached to or integrally formed with central drive gear 122, central drive gear 122 rotates in the first direction simultaneously with mouthpiece cover 108. As described above, movement of mouthpiece cover 108 to the second position opens and positions cavities 164A, 164B of each blister strip 160A, 160B, thereby enabling a patient to subsequently inhale powdered medicament 168A, 168B simultaneously.

[0135] However, when the mouthpiece cover 108 returns to its closed first position, the reverse rotation of the pawl 125 is not transmitted to the center drive gear 122 because the pawl arm 125A does not interact with the inner stop surface 123A of the ratchet wheel 123. More specifically, when the pawl 125 rotates in the second opposite direction (i.e., counterclockwise), the pawl arm 125A deflects radially inward, so that no significant torque is transmitted to the ratchet wheel 123 and the center drive gear 122. Figure 10A As shown, frictional resistance between the pawl 125 and the ratchet 123 may tend to briefly drive the ratchet 123 in a second, opposite direction (i.e., counterclockwise), but such back-winding is prevented by interaction between an outer stop surface 123B of the ratchet 123 and the flexible arm 121 on the retainer plate of the inhaler device 100.

[0136] In one embodiment, a detent (not shown) may be disposed between the inner surface of the mouth cover 108 and the outer surface of the housing 102. The detent may be a matching protrusion and groove configured to temporarily block or prevent movement of the mouth cover 108 relative to the housing 102 until a user applies a force to the mouth cover 108 (i.e., when opening the mouth cover 108) to release the detent by causing one of the matching features of the detent to exit or move beyond another of the matching features of the detent. For example, a protrusion, ridge, or other raised structure may be formed on the outer surface of the housing 102, and a matching groove, pit, or other recessed structure may be formed on the inner surface of the mouth cover 108. Alternatively, a protrusion, ridge, or other raised structure may be formed on the inner surface of the mouth cover 108, and a matching groove, pit, or other recessed structure may be formed on the outer surface of the housing 102. When the mouth cover 108 is in Figure 1A When the user applies a force sufficient to overcome the friction between the mating protrusion and the groove, the mouthpiece cover 108 begins to open and move away from the mouthpiece cover 108. Figure 1A The stop structure is configured to prevent or inhibit accidental opening of the mouthpiece cover 108. In addition, the stop structure is configured to account for rotational play or tolerances within the ratchet mechanism 124, so that the dispensing mechanism and the counting mechanism in the inhaler device 100 are actuated upon the first or initial movement of the mouthpiece cover 108 away from the closed position toward the open position.

[0137] like Figure 11 As shown, the central drive gear 122 directly or indirectly drives the remaining gears of the dispensing subassembly 120. The gear train arrangement enables incremental indexing or advancement of the blister strips 160A, 160B via the first and second positioning gears 130A, 130B, and also enables winding of the top and bottom sheets of the blister strips 160A, 160B (via the top sheet take-up gears 150A, 150B and the bottom sheet take-up gears 128A, 128B, respectively) as a result of rotational movement of the mouthpiece cover 108 in a first direction from its closed first position to its open second position. As the central drive gear 122 rotates with the mouthpiece cover 108 in the first direction, it cooperates with or directly drives the second positioning gear 130B to rotate in a second, opposite direction. The second reel 131B, and thereby the second blister strip 160B, also rotates in the second, opposite direction. When the second positioning gear 130B rotates in the second opposite direction, the second positioning gear 130B engages with the first positioning gear 130A or directly drives the first positioning gear 130A to rotate in the first direction. The first reel 131A and the first blister strip 160A driven thereby also rotate in the first direction.

[0138] In one embodiment, the first direction is clockwise and the second, opposite direction is counterclockwise. In the illustrated embodiment, when the mouthpiece cover 108 is opened, the central drive gear 122 rotates in a clockwise direction. Consequently, the second positioning gear 130B (along with the second reel 131B and the second blister strip 160B) rotates in a counterclockwise direction, while the first positioning gear 130A (along with the first reel 131A and the first blister strip 160A) rotates in a clockwise direction. However, as one of ordinary skill in the art will appreciate, the first direction may alternatively be counterclockwise and the second, opposite direction may be clockwise, as long as the gear train formed by the dispensing subassembly 120 moves or advances the first blister strip 160A in opposite directions from the second blister strip 160B. Furthermore, as one of ordinary skill in the art will appreciate, the gear train formed by the dispensing subassembly 120 may include one or more idler gears (not shown) that are used to change the order of rotation between the central drive gear 122, the second positioning gear 130B, and the first positioning gear 130A. As long as the gear train moves or advances the first blister strip 160A in the opposite direction from the second blister strip 160B, the presence of such an idler gear does not affect the overall function of the gear train. For example, an idler gear (not shown) can be provided between the central drive gear 122 and the first positioning gear 130A, and the central drive gear 122 (rotating in a first direction) directly drives the idler gear to rotate in a second, opposite direction. The idler gear can be positioned so as to directly drive the first positioning gear 130A in the first direction, and the first positioning gear 130A directly drives the second positioning gear 130B in the second, opposite direction.

[0139] To maintain tension on the blister strips 160A and 160B, the first bottom sheet take-up gear 128A and the second bottom sheet take-up gear 128B rotate simultaneously with and in the same direction as the first positioning gear 130A and the second positioning gear 130B, respectively, and the first top sheet take-up gear 150A and the second top sheet take-up gear 150B rotate simultaneously with and in opposite directions as the first positioning gear 130A and the second positioning gear 130B, respectively. When the center drive gear 122 rotates in a first direction, the center drive gear 122 meshes with the first idler gear 126 or directly drives the first idler gear 126 to rotate in a second, opposite direction, and the first idler gear 126 meshes with the first bottom sheet take-up gear 128A or directly drives the first bottom sheet take-up gear 128A to rotate in the first direction. The first spindle 129A and the bottom sheet 162A wound thereby also rotate in the first direction, thereby winding or reeling in the empty bottom sheet 162A of the first blister strip 160A as the first blister strip 160A is advanced by the dispensing subassembly 120. Furthermore, the first top sheet reeling gear 150A interacts with or is driven by the first positioning gear 130A. As the first positioning gear 130A rotates in the first direction, the first top sheet reeling gear 150A is driven to rotate in a second, opposite direction to reel in the top sheet 166A of the first blister strip 160A.

[0140] When the central drive gear 122 rotates in the first direction, as described above, the first idler gear 126 is driven to rotate in the second, opposite direction. The first idler gear 126 engages with or directly drives the second idler gear 127 to rotate in the first direction. The second idler gear 127 engages with or directly drives the second bottom sheet take-up gear 128B to rotate in the second direction. Consequently, the second main shaft 129B and the bottom sheet 162B wound thereby also rotate in the second direction, thereby winding or rewinding the empty bottom sheet 162B of the second blister strip 160B as the second blister strip 160B is advanced by the dispensing subassembly 120. Furthermore, the second top sheet take-up gear 150B interacts with or is driven by the second positioning gear 130B. As the second positioning gear 130B rotates in the second opposite direction, the second top sheet take-up gear 150B is driven to rotate in the first direction to take up the top sheet 166B of the second blister strip 160B.

[0141] Now go to Figure 12A and Figure 12B as well as Figures 13A-13EThe first and second tensioning mechanisms 151A, 151B will be described in greater detail. The tensioning mechanisms 151A, 151B are used to peel the top sheets 166A, 166B from the first and second blister strips 160A, 160B, respectively, to maintain a consistent peel distance or amount throughout the life of the device. More specifically, the tensioning mechanisms 151A, 151B ensure that the peel distance of the top sheets 166A, 166B is configured to properly open the cavities 164A, 164B for each dose, thereby enabling efficient dispensing of the powdered medicament 168A, 168B to the user. If the peel distance or amount is too low, the cavities may not be fully exposed, making it more difficult to adequately expel the powdered medicament contained therein during inhalation. Furthermore, if the peel distance or amount is too high, the next or subsequent cavities may be exposed prematurely, risking loss of some of the medicament contained therein, potentially resulting in an underdose during the next dispensing. Tensioning mechanism 151A, 151B is also used to keep the sheet tension force of top sheet 166A, 166B during the device service life.Top sheet 166A, 166B need to be in consistent tension force, to guarantee the correct operation of inhaler device 100.The tension force of each top sheet 166A, 166B is associated with user-operated inhaler device 100 and mobile mouth cover 108 required forces.Therefore, guarantee that consistent tension force among top sheet 166A, 166B provides more consistent user experience during the device service life.The tension force that remains consistent in top sheet 166A, 166B also brings more consistent and lower peak mechanical stress in top sheet 166A, 166B and the surrounding components, thereby reduced the risk of mechanical failure during use.

[0142] The first tensioning mechanism 151A is associated with the first top sheet take-up gear 150A for taking up the top sheet 166A of the first blister strip 160A, and the second tensioning mechanism 151B is associated with the second top sheet take-up gear 150B (see FIG. Figure 4A and Figure 4 B) for winding the top sheet 166B of the second blister strip 160B. For the sake of brevity, only the first tensioning mechanism 151A will be described below, as the second tensioning mechanism 151B operates in the same manner. It will be apparent to one of ordinary skill in the art that certain features or components of the second tensioning mechanism 151B (i.e., the cam surface described herein) will be modified to extend in the opposite direction to that described below, such that the second tensioning mechanism 151B is configured to operate in the opposite direction to the first tensioning mechanism 151A. Advantageously, the first and second tensioning mechanisms 151A, 151B utilize some components of the same design (i.e., the compression spring and take-up hub described herein), which helps reduce manufacturing and assembly costs compared to other inhaler devices that utilize dedicated components for each side of the device to achieve operation in opposite directions.

[0143] The tensioning mechanism 151A includes a first top sheet take-up gear 150A, a take-up hub 152A having a hook portion 153A integrally formed thereon or fixed thereto, a base 154A having a cam surface 155A integrally formed thereon or fixed thereto, a nut 156A, a shaft 157A, and a compression spring 158A extending or disposed between the nut 156A and the top end of the take-up hub 152A. The compression spring 158A biases the nut 156A downwardly toward the base 154A into the cam surface 155A. The compression spring 158A is disposed around or around the shaft 157A and longitudinally or axially adjacent to the nut 156A. The take-up hub 152A is disposed around or around the nut 156A and the compression spring 158A. In other words, the take-up hub 152A surrounds or encloses the nut 156A and the compression spring 158A contained therein.

[0144] The top sheet 166A of the first blister strip 160A is fixed or attached to the take-up hub 152A by the hook portion 153A so that when the take-up hub 152A rotates, the top sheet 166A of the first blister strip 160A is wrapped around it. The hook portion 153A is configured to be attached to the front end of the top sheet 166A so that the rotation of the take-up hub 152A causes the top sheet 166A to be wrapped around or wound around the take-up hub 152A. Since the take-up hub 152A may complete multiple rotations during the service life of the inhaler device 100, the top sheet 166A of the first blister strip 160A may be wrapped around itself multiple times, causing its radial position on the take-up hub 152A to increase, i.e., the radial distance of the top sheet 166A from each subsequent wrapping of the take-up hub 152A increases with each wrapping. Because rotation of the base 154A corresponds to rotation of the first top sheet take-up gear 150A, the base 154A rotates a fixed amount for each dose, and the distance that the top sheet 166A of the first blister strip 160A peels away from the bottom sheet 162A is determined by the tangential travel of the top sheet 166A of the first blister strip 160A at the take-up hub 152A. This tangential travel can be calculated as θ*r, where θ is the rotation angle of the take-up hub 152A per dose, and r is the radial position of the top sheet 166A of the first blister strip 160A on the take-up hub 152A. As the radial position of the top sheet 166A of the first blister strip 160A increases, the tangential travel increases for a fixed rotation of the take-up hub 152A. Without any modifications to the mechanism, the top sheet 166A of the first blister strip 160A will peel further away from the bottom sheet 162A later in the device's life. This is called the winding effect and is achieved by Figure 12A and Figure 12B to illustrate with comparison. Figure 12A is a schematic diagram of the first blister strip 160A at the beginning of the device's service life, Figure 12B is a schematic diagram of the first blister strip 160A at a later stage in the useful life of the device. Figure 12B It is shown that as the first blister strip 160A is wrapped around the take-up hub 152A, the effective diameter of the take-up hub 152A increases.

[0145] To ensure that the top sheet 166A of the first blister strip 160A is peeled the same amount each time and to compensate for wrapping effects, the tensioning mechanism 151A includes a cam surface 155A, a nut 156A, and a compression spring 158A. The cam surface 155A, nut 156A, and compression spring 158A function to provide a constant driving tension to the top sheet 166A throughout the entire strip length. As will be described in greater detail herein, increased tension along the top sheet 166A causes the take-up hub 152A to rotate relative to the base 154A, reducing the tension along the top sheet 166A. As the take-up hub 152A rotates relative to the base, the compression spring 158A is compressed, and the axial compression of the compression spring 158A is converted into a torque applied to the take-up hub 152A.

[0146] refer to Figures 13B-13D , the structure of the tensioning mechanism 151A will be described in more detail. The base 154A is attached to the first top sheet winding gear 150A or is integrally formed with the first top sheet winding gear 150A so as to rotate as an integral component when the first top sheet winding gear 150A is rotationally driven. For example, the base 154A may include a plurality of gear teeth integrally formed with or fixed to its outer peripheral surface to form the first top sheet winding gear 150A. The shaft 157A extends from the base 154A and is attached to the base 154A or is integrally formed with the base 154A so as to rotate together with the base 154A. Therefore, when the first top sheet winding gear 150A is rotationally driven, the shaft 157A, the base 154A, and the first top sheet winding gear 150A rotate as an integral component.

[0147] The nut 156A is disposed between the take-up hub 152A and the base 154A and is coupled to each of the take-up hub 152A and the base 154A. The nut 156A is disposed on the periphery of the shaft 157A or is disposed around the shaft 157A and is coupled to the base 154A by at least one inwardly extending rib 119A that protrudes or extends radially inward from the inner circumferential surface of the nut 156A. In one embodiment, the nut 156A includes a plurality of inwardly extending ribs 119A that serve as cam followers. The plurality of inwardly extending ribs 119A are preferably spaced circumferentially at equal increments. More specifically, as shown in FIG. Figure 13CAs best shown, the inwardly extending ribs 119A of the nut 156A are disposed on and engage the cam surface 155A of the base 154A. Furthermore, the nut 156A is coupled to the take-up hub 152A via a spline connection 159A, such that the take-up hub 152A rotates with the nut 156A and does not permit relative rotation between the take-up hub 152A and the nut 156A. In other words, due to the spline connection 159A, the take-up hub 152A is rotationally locked to the nut 156A, such that the nut 156A and the take-up hub 152A rotate as a single unit. Figure 13C As best shown, the spline connection 159A includes an outwardly extending rib 117A that projects or extends radially outward from the outer circumferential surface of the nut 156A and is received within the axial groove 115A of the take-up hub 152A. The outwardly extending rib 117A is permitted to slide or move axially along the axial groove 115A, thereby permitting the nut 156A to slide or move axially relative to the take-up hub 152A, but the outwardly extending rib 117A does not permit the nut 156A to rotate relative to the hub 152A.

[0148] When the base 154A rotates in the second opposite direction together with the first top sheet take-up gear 150A, the nut 156A and the take-up hub 152A also rotate in the second opposite direction due to the interaction between the nut 156A, the compression spring 158A, and the cam surface 155A of the base 154A. More specifically, when the base 154A is rotationally driven in the second opposite direction, the take-up hub 152A is configured to rotate in the second opposite direction by the engagement of the inwardly extending ribs 119A of the nut 156A with the cam surface 155A. Figure 14DAs shown, cam surface 155A includes alternating portions of vertical surface 111A and portions of angled or inclined surface 113A. Vertical surface 111A extends generally parallel to the longitudinal axis of shaft 157A. When base 154A is rotationally driven in a second, opposite direction (i.e., counterclockwise in this embodiment), nut 156A and the winding hub 152A, which is rotationally locked thereto, rotate together with base 154A in the second, opposite direction. The interaction between compression spring 158A, nut 156A, and cam surface 155A causes cam surface 155A to apply a torque to nut 156A in a direction that pushes nut 156A down cam surface 155A. Compression spring 158A presses nut 156A against inclined surface 113A of cam surface 155A, which applies a torque to winding hub 152A, thereby driving winding hub 152A in the second, opposite direction. Due to this interaction, when the base 154A moves counterclockwise, the nut 156A and the take-up hub 152A also rotate counterclockwise with the base 154A. It will be understood by those skilled in the art that the structure of the cam surface 155A is exemplary. The cam surface 155A can be a threaded or other inclined surface.

[0149] Although the take-up hub 152A rotates along with the base 154A in the second, opposite direction due to the interaction between the nut 156A, the compression spring 158A, and the cam surface 155A of the base 154A, relative rotation is permitted between the take-up hub 152A and the base 154A. More specifically, when sufficient torque is applied between the take-up hub 152A and the base 154A, the take-up hub 152A will rotate relative to the base 154A. Because the take-up hub 152A is permitted to rotate relative to the base 154A in a direction that reduces the tension in the top sheet 166A (i.e., in the first direction), this relative rotation stabilizes or balances the tension in the top sheet 166A via the deflection of the compression spring 158A. Thus, the tensioning mechanism 151A acts as a torsion or torque limiter between the take-up hub 152A and the base 154A to control the tension in the top sheet 166A of the first blister strip 160A.

[0150] In addition to the torque applied to nut 156A by cam surface 155A, there is another torque acting in the opposite direction on nut 156A, resulting from the interaction between nut 156A and take-up hub 152A via outwardly extending ribs 117A. This opposing torque results from the tension in top sheet 166A, which acts to apply torque to take-up hub 152A. The two opposing torques on nut 156A are in equilibrium, so compression spring 158A (via nut 156A and cam surface 155A) effectively balances the tension in top sheet 166A. If the tension in top sheet 166A increases, nut 156A will move further upward along cam surface 155A, and the force of compression spring 158A will increase, compensating for the increased tension.

[0151] More specifically, due to the aforementioned wrapping effect, the radial position of the top sheet 166A of the first blister strip 160A increases as the take-up hub 152A rotates. This increase in radial position requires the take-up hub 152A to peel a longer length of the top sheet 166A. This change in the peeling angle between the top sheet 166A of the first blister strip 160A and the bottom sheet 162A of the first blister strip 160A increases, causing the tension on the top sheet 166A to increase. As the tension on the top sheet 166A increases, the torque applied by the top sheet 166A to the take-up hub 152A also increases. However, this torque does not continue to increase. Instead, the take-up hub 152A begins to rotate in the second direction relative to the base 154A, and the nut 156A spirally moves upward along the cam surface 155A of the base 154A, thereby compressing the compression spring 158A. More specifically, when the take-up hub 152A and the nut 156A rotationally locked thereto begin to rotate in the second direction due to increased tension on the top sheet 166A, the base 154A and the cam surface 155A remain stationary, and the inwardly extending rib 119A of the nut 156A moves along the inclined surface 113A of the cam surface 155A in a direction toward the compression spring 158A, i.e., upwardly along the cam surface 155A. As the nut 156A presses against the compression spring 158A, the compression spring 158A is compressed. As the nut 156A moves relative to the base 154A, the nut 156A also moves axially relative to the take-up hub 152A because the outwardly extending rib 117A of the nut 156A is allowed to move axially within the axial groove 115A of the take-up hub 152A. Thus, rotation of the take-up hub 152A relative to the base 154A causes the nut 156A to move axially relative to the take-up hub 152A and relative to the base 154A, and further axial movement of the nut 156A toward the compression spring 158A axially compresses the compression spring 158A. Because the take-up hub 152A is rotationally locked to the nut 156A via the spline connection 159A, the nut 156A converts the axial force of the compression spring 158A into a torque applied to the take-up hub 152A. The combination of the compression spring 158A, the nut 156A, and the cam surface 155A thus provides a torque that acts to resist or counteract the relative rotation between the take-up hub 152A and the base 154A, thereby maintaining consistent tension in the top sheet 160A.

[0152] The take-up hub 152A is axially restrained relative to the base 154A by providing a clamp or retaining structure 149A between the shaft 157A and the take-up hub 152A. More specifically, the retaining structure 149A (at the Figure 13B154A) is disposed between the top end of the take-up hub 152A and the compression spring 158A to maintain the correct relative axial position between the take-up hub 152A and the base 154A. The retaining structure 149A may be a clamp, a bayonet structure, or other suitable component for maintaining the correct relative axial position between the take-up hub 152A and the base 154A. In another embodiment (not shown), the retaining structure may be attached to the interior of the housing 102 to maintain the correct relative axial position between the take-up hub 152A and the base 154A.

[0153] Figure 13E The figure illustrates the changing position of nut 156A throughout the life of the device. In the initial assembly state shown in the left figure, before the take-up hub 152A is attached to the first blister strip 160A, nut 156A is located at the bottom end of cam surface 155A. Cam surface 155A is designed so that in this position, even with the potential axial force from compression spring 158A, no torque is generated between take-up hub 152A and base 154A. When the device is assembled, top sheet 166A is assembled under tension to ensure efficient peeling from the first dose onwards. Consequently, nut 156A moves slightly upward along cam surface 155A, away from the perpendicular surface 111A of cam surface 155A. More specifically, as shown in the center figure, when the device is assembled, top sheet 166A is attached to take-up hub 152A, which rotates relative to base 154A, causing nut 156A to move upward along cam surface 155A. The compression spring 158A is deflected or slightly compressed relative to its uncompressed length, imparting a preload to the compression spring 158A. This preload ensures that the top sheet 166A of the first blister strip 160A has sufficient tension to allow it to be peeled from the bottom sheet 162A of the first blister strip 160A during the initial stages of the device's life. The dimensions of the compression spring 158A and the angle of the cam surface 155A should be configured to provide a minimum tension in the top sheet 166A of the first blister strip 160A that is greater than the maximum force required to peel the top sheet 166A of the first blister strip 160A from the bottom sheet 162A of the first blister strip 160A. In this assembled state, the combination of the compression spring 158A, nut 156A, and cam surface 155A provides a torque between the base 154A and the take-up hub 152A, which is counteracted by the tension in the top sheet 166A. As shown in the figure on the right, the tension in the top sheet 166A of the first blister strip 160A increases over the life of the inhaler device 100. As the tension in the top sheet 166A increases, the nut 156A moves further upward along the cam surface 155A, whereby the increase in tension in the top sheet 166A is balanced by the further deflection of the compression spring 158A.

[0154] The angle of each inclined surface 113A of cam surface 155A or slope are configured to keep the tension force of the sheet of top sheet 166A, 166B consistent during the device service life.As mentioned above, for guaranteeing the correct operation of inhaler device 100, top sheet 166A, 166B need be in consistent tension force.Usually, the angle of each inclined surface 113A of cam surface 155A or slope are selected to guarantee that nut 156A moves along the cam surface 155A of pedestal 154A in the operating procedure of inhaler device 100, and can not move and exceed or cross vertical surface 111A.In one embodiment, the inclined surface 113A of cam surface 155A extends with the angle between 35 degree to 55 degree with respect to the longitudinal axis of pedestal 154A.In one embodiment, the inclined surface 113A of cam surface 155A extends with the angle between 40 degree to 50 degree with respect to the longitudinal axis of pedestal 154A. In one embodiment, the inclined surface 113A of the cam surface 155A extends at an angle of approximately 45 degrees relative to the longitudinal axis of the base 154A, with the term "approximately" used herein including a tolerance of three degrees. In one embodiment, the slope of the inclined surface 113A of the cam surface 155A is between 0.70 and 1.0. In one embodiment, the slope of the inclined surface 113A of the cam surface 155A is between 0.80 and 0.95. In another embodiment, the slope of the inclined surface 113A of the cam surface 155A is between 0.7 and 1.4. In another embodiment, the slope of the inclined surface 113A of the cam surface 155A is between 1.0 and 1.4. The slope of the inclined surface 113A of the cam surface 155A can be constant over the length of the inclined surface, or can vary over the length of the inclined surface.

[0155] The radial width of the inclined surfaces 113A of the cam surface 155A is configured to optimize the amount of friction between the nut 156A and the cam surface 155A. Typically, a larger radial width of the inclined surfaces 113A of the cam surface 155A results in increased friction between the components, while a smaller radial width of the inclined surfaces 113A of the cam surface 155A may cause the nut 156A to undesirably disengage from the cam surface 155A. In one embodiment, the radial width of each inclined surface 113A of the cam surface 155A is between 1 mm and 3 mm. In one embodiment, the radial width of each inclined surface 113A of the cam surface 155A is between 1.5 mm and 2.5 mm. In one embodiment, the radial width of each inclined surface 113A of the cam surface 155A is approximately 2 mm, where "approximately" as used herein includes a tolerance of 0.2 mm.

[0156] Now turn Figures 14A-14D, the counter subassembly 134 will be described in more detail. The dispensing subassembly 120 preferably directly drives the counter subassembly 134, causing the dose counter to automatically increment as the inhaler device 100 positions or delivers a dose of medication. Thus, the user does not need to perform any additional steps to update the dose counter, other than operating the mouthpiece cover 108 to activate the dispensing subassembly 120. When the mouthpiece cover 108 is opened, the dose counter automatically increments, allowing the user to intuitively understand the dose counter indication.

[0157] The counter subassembly 134 includes a first counting wheel or units ring 140 and a second counting component or tens mechanism 136. The first counting wheel 140 is driven by the dispensing subassembly 120 of the inhaler device 100 to rotate a fixed angle for each administered dose, and in this embodiment, the first counting wheel 140 is configured to display the second digit of a two-digit count of available doses. The second counting component 136 is intermittently driven by the first counting wheel 140 so that the second counting component 136 rotates a fixed angle for each revolution of the first counting wheel 140, which will be described in more detail below. In this embodiment, the second counting component 136 displays the first digit of a two-digit count of available doses. Therefore, as Figure 14A and 14B As shown, the first count wheel 140 and the second count component 136 together display the number of doses remaining in the inhaler device 100. Although the embodiment of the counter subassembly described herein displays two digits, it will be understood by those skilled in the art that if the total number of doses in the inhaler device exceeds 100, the count indicia may be modified to display three digits.

[0158] The front or indicia display face or indicia display surface 141 of the first counting wheel 140 includes count indicia disposed thereon, the count indicia including the unit digit or "ones" digit. More specifically, as shown in FIG. Figure 14A and 14B As shown, the counting marks of the first counting wheel 140 include the numbers 0, 1, 2, 3, 4, 5, 6, 7, 8, and 9, which are distributed in a circular manner near the outer edge of the marking display surface 141. The angle between each number is equal to the angle that the first counting wheel 140 rotates for each dose. The marking display surface 141 is a planar structure.

[0159] The front or indicia display surface 137 of the second counter member 136 includes count indicia disposed thereon, including the tens digit. The count indicia of the second counter member 136 include the numerals 3, 2, and 1, and may also include a single mark SF and a double mark DF near the outer edge of the indicia display surface 137. The angle between each count indicia or numeral represents the angle of rotation of the second counter member 136 for each rotation of the first count wheel 140. The indicia display surface 137 is a planar structure.

[0160] The display window 104 in the housing 102 is positioned so that a numeral on the first count wheel 140 and a numeral on the second count unit 136 are visible in the display window, and are adjacent to each other to form two digits. The numeral that shows on the second count unit 136 reflects or tracks the " tens " digit of the remaining dose in the inhaler device 100, and the numeral that shows on the first count wheel 140 reflects or tracks the " individual " digit of the remaining dose. When the quantity of the remaining dose was lower than 10, the second count unit 136 would show a single mark SF in the display window 104, rather than the numeral zero or in place of the numeral zero. For example, in one embodiment, the single mark SF could be a colored block without numerals thereon, to indicate that the available dose in the inhaler device 100 is about to run out. When the quantity of the remaining dose reached zero, the second count unit 136 would show a double mark DF in the display window 104, to substitute numerals. In one embodiment, for example, the double mark DF could be a colored block without numerals thereon, which covers the numeral of the first count wheel 140, to provide the user with the clear visual feedback that there is no remaining dose in the inhaler device 100. The double marking DF is configured to cover the numbers of the first count wheel 140 when no dose remains in the inhaler device 100 .

[0161] exist Figures 14A-14D In the embodiment of the present invention, the units or "ones" digits are arranged in a decreasing order in a first direction around the circumference of the first count wheel 140, while the "tens" digits are arranged in a decreasing order in a second, opposite direction around the periphery of the second counter component 136. Although the counter subassembly is described herein as displaying the number of doses remaining in the inhaler device 100, one of ordinary skill in the art will appreciate that the counter subassembly can be modified to display the number of doses delivered by the inhaler device by reversing the order of the count indicia provided on the counter subassembly.

[0162] Now go to Figure 14C and 14D , the structure and operation of the first counting wheel 140 and the second counting member 136 will be described in more detail. Figure 14C It is along Figure 14B A cross-sectional view taken along line CC of the counter subassembly is located midway between the marking display surface and the opposing rear surface. Figure 14D It is along Figure 14C DD, which is adjacent to the opposite rear surface of the counter subassembly. The terms "front" and "rear" are used herein for illustrative purposes only and are meant to refer to the conventional grip of a user when using an inhalation device, wherein the front side of the device includes a display window for the counter mechanism.

[0163] The first count wheel 140 is an annular or ring-shaped member having a front or indicia display surface 141 and an opposing rear surface including a count gear 148, as shown. Figure 14D 140 . The counting gear 148 can be integrally formed with or attached to the first counting wheel 140. An outer circumferential surface or outer circumferential side 143 extends between the front and rear surfaces of the first counting wheel 140. The outer circumferential side 143 can be stepped, having a smaller diameter along the rear surface of the first counting wheel 140 and a larger diameter along the front surface of the first counting wheel 140. By comparison Figure 14C and Figure 14D The relative diameters in FIG. 1 and FIG. 2 show the stepped features of the outer circumferential side surface 143. In other words, the outer diameter of the mark display surface 141 of the first counting wheel 140 is greater than the outer diameter of the counting gear 148.

[0164] Near the count gear 148, the first count wheel 140 includes a single tooth or protrusion 142 extending radially outward from an outer circumferential side surface 143. Along the front or indicia display surface 141 of the first count wheel 140, the outer circumferential side surface 143 is generally circular with a clearance cutout or clearance indent 145 formed around the single tooth 142. The function of the clearance indent 145 will be described in more detail below. In another embodiment of the present invention (not shown), the first count wheel 140 may include more than one tooth or protrusion 142. Therefore, although at least one single tooth or protrusion is required and a single tooth is believed to be sufficient and advantageously simplifies the design and reduces the material cost of the first count wheel 140, embodiments thereof may include more than one tooth or protrusion.

[0165] The second counting member 136 is configured to rotate about a pivot point 147. Figure 14C and 14D As shown in the cross-sectional view of FIG, the second counter member 136 is a non-annular or partially disc-shaped member having a front or indicia display surface 137 and an opposite rear surface, the rear surface including a plurality of notches 138. An outer surface or outer side 139 extends between the front and rear surfaces of the second counter member 136. The outer side 139 can be stepped, having a smaller radial dimension along the rear surface of the second counter member 136 and a larger radial dimension along the front of the second counter member. By comparison Figure 14B and 14C The relative diameters of the middle and outer sides 139 and the stepped features of the outer side 139 are clearly visible.

[0166] 137. A plurality of notches 138 are formed in the lateral side 139 of the second counter unit 136 and do not extend through the front or marking display surface 137. In one embodiment, the second counter unit 136 comprises four notches 138, but the quantity of the notches is exemplary and depends on the capacity or the total number of available doses in the inhaler device 100. Each notch 138 extends radially inwardly towards the pivot point 147 of the second counter unit 136 and is configured to cooperate with or receive the single tooth 142 of the first count wheel 140. The lateral side 139 of the second counter unit 136 can be considered to comprise a plurality of segmented portions 135, and each segmented portion 135 extends between two adjacent or contiguous notches 138. Along each segmented portion 135, the lateral side 139 of the second counter unit 136 is concave, and forms an inverted bend or an arcuate recess 133 that matches the outer circumferential side 143 of the first count wheel 140.

[0167] The first counter wheel 140 is driven by the second bottom sheet take-up gear 128B of the dispensing subassembly 120, rotating a fixed angle for each dose dispensed. More specifically, a drive gear 144 is attached to opposite ends of the second spindle 129B of the second bottom sheet take-up gear 128B, allowing the drive gear 144, the second spindle 129B, and the second bottom sheet take-up gear 128B to rotate synchronously as a single component. When the mouthpiece cover 108 is opened, the drive gear 144 rotates in conjunction with the second bottom sheet take-up gear 128B in a second, opposite direction. The drive gear 144 cooperates with or directly drives the idler gear 146 to rotate in the first direction, while the idler gear 146 cooperates with or directly drives the counter gear 148 to rotate in the second, opposite direction. Consequently, the counter gear 148 rotates in the same direction as the drive gear 144. It is obvious to those skilled in the art that the rotation of the transmission gear 144 and the counting gear 148 in the same direction can also be achieved by a gear train, wherein the transmission gear 144 directly drives the counting gear 148 in the same direction. Figures 14B-14D As shown, when the counter gear 148 is an internal gear and the transmission gear 144 is a spur gear or planetary gear, the transmission gear 144 meshes with or directly drives the internal counter gear 148 in the same direction, thereby achieving the desired rotation scheme. The first count wheel 140 is attached to the count gear 148 so as to rotate together as an integral component, so that when the mouthpiece cover 108 is opened, the first count wheel 140 rotates in a second, opposite direction. Therefore, various suitable gear trains can be used herein to enable the transmission gear 144 and the counter gear 148 to rotate in the same direction.

[0168] As in Figure 14C As best shown in FIG, the second counter member 136 is positioned adjacent to or in close proximity to the outer circumferential side 143 of the first count wheel 140 such that a single tooth 142 of the first count wheel 140 engages one of the plurality of notches 138 of the second counter member 136 once per rotation of the first count wheel 140, thereby intermittently rotating the second counter member 136. In other words, each time the first count wheel 140 completes one full rotation, the single tooth 142 engages the notch 138 of the second counter member 136 and rotates or turns the second counter member 136 a fixed amount. Thus, the second counter member 136 rotates a fixed amount for each rotation of the first count wheel 140. Because the first count wheel 140 directly drives the second counter member 136, the second counter member 136 rotates in the opposite direction of the first count wheel 140. Figures 14A-14D In the embodiment of the present invention, the second counter member 136 is configured to rotate in a first direction and the first counter wheel 140 is configured to rotate in a second, opposite direction. When the single tooth 142 of the first counter wheel 140 does not engage the notch 138 of the second counter member 136, the second counter member 136 remains stationary and does not rotate.

[0169] The second counting member 136 is disposed adjacent to or side by side with the first counting wheel 140 in the same plane, so that the second counting member 136 rotates on a different rotation axis than the first counting wheel 140. In other words, the first counting wheel 140 rotates about a first axis, and the second counting member 136 rotates about a second axis, which is parallel to and spaced apart from the first axis.

[0170] As described above, along each segment 135, the outer side surface 139 of the second counting member 136 is concave and forms an arcuate notch 133 that matches the outer circumferential side surface 143 of the first counting wheel 140. Figure 14C As best shown, the geometry of the arcuate notch 133 matches the circular profile of the first count wheel 140 to prevent the second counter member 136 from inadvertently rotating when not engaged with the first count wheel 140. Specifically, the geometry or profile of the outer side 139 of the second counter member 136 ensures that the second counter member 136 does not rotate but remains stationary when a single tooth 142 of the first count wheel 140 is not engaged with a notch 138 of the second counter member 136. Conversely, when a single tooth 142 of the first count wheel 140 is engaged with or received within a notch 138 of the second counter member 136, a clearance notch 145 of the first count wheel 140 allows the second counter member 136 to briefly rotate with the first count wheel 140 to change the display of the tens digit.

[0171] Although it is an important consideration to show the quantity of remaining available dose in a relatively large and clear manner for readability in an inhaler device, there is usually a trade-off between the size of the dose counter display and the dose counter mechanism in the space occupied inside the inhaler device housing. Counter subassembly 134 advantageously splits the two-digit number representing the available dose into multiple parts, which makes it easier to realize a larger digital display size in the same amount of space in the housing of the inhaler device. In addition, counter subassembly 134 does not need any type of stop structure (detent feature) to keep or maintain its position. For example, other dose counter mechanisms utilize flexible arms as stop structures to keep the position of dose counter mechanisms, and need to apply certain force so that flexible arms are deflected when the dose counter mechanism is incremented. This stop structure increases the operating force of the device, which is undesirable. Counter subassembly 134 does not need any type of intermediate component to be set between the counter components. By directly driving the second counting component 136 by the first counting wheel 140, the structure of counter subassembly 134 is simplified, and the total number of components of the inhaler device 100 is minimized, thereby reducing the total cost and complexity of the inhaler device 100. Furthermore, omitting the intermediate member between the counter components means that there is a shorter tolerance chain for the alignment between the first counter wheel 140 and the second counter component 136, thereby improving the alignment consistency between the first and second digits in a two-digit display.

[0172] exist Figures 14A-14D In the embodiment, Figure 14B As best shown, the front or indicia display surface 137 of the second counter member 136 covers or overlies a portion of the front or indicia display surface 141 of the first count wheel 140. Thus, the "units" digit on the first count wheel 140 and the "tens" digit on the second count member 136 are not located in the same plane. In other words, the "units" digit on the first count wheel 140 and the "tens" digit on the second count member 136 are located on different planes or levels, with the "tens" digit being located higher relative to the "units" digit, or being positioned closer to the display window 104 of the inhaler device 100.

[0173] Figure 15A and Figure 15BAnother embodiment of the counter subassembly 1534 is shown in which the tens digit is in the same plane or at the same horizontal position as the units digit. The counter subassembly 1534 is the same as the counter subassembly 134 described above, except for the differences described herein. One advantage of the configuration of the counter subassembly 1534 is that having the tens digit at the same level as the units digit improves the readability of the display, particularly when viewed from a smaller viewing angle. The circular boss 1501 is integrally formed with or fixed to the first count wheel 1540 to elevate or raise the units digit thereon to the same height as the tens digit on the second count component 1536. The circular boss 1501 forms the front or marking display face or marking display surface 1541 of the first count wheel 1540. In addition, as Figure 15B As shown, the dual markings DF on the second counter member 1536 are disposed on a raised or stepped step 1503 integrally formed with or affixed to the second counter member 1536, such that the dual markings DF are configured to overlap a number on the first count wheel 1540 at the end of the useful life of the device. More specifically, the raised or stepped step 1503 extends radially outward from an outer surface or side 1539 of the second counter member 1536, such that at the end of the useful life of the device, the raised or stepped step 1503 extends over or overlaps a number on the first count wheel 1540. In this embodiment, except for the raised or stepped step 1503, the front or marking display face or marking display surface 1537 of the second counter member 1536 is coplanar with the front or marking display surface 1541 of the first count wheel 1540.

[0174] exist Figure 16A and Figure 16B , another embodiment of a counter subassembly 1634 that can be used within the inhaler device 100 is depicted. The counter subassembly 1634 includes a first count wheel or units ring 1640 and a second count member or tens mechanism 1636. The counter subassembly 1634 is similar to the counter subassembly 134, but utilizes a sliding member that moves along a linear path instead of the rotatable second count member 136.

[0175] Similar to the counter subassembly 134, the dispensing subassembly 120 preferably directly drives the counter subassembly 1634 so that the dose counter automatically increments while the inhaler device 100 positions or delivers the medicament dose. The first count wheel 1640 is driven by the dispensing subassembly 120 of the inhaler device 100, rotates a fixed angle per dose, and is configured to display the second digit of the two-digit number of the available dose number. The first count wheel 1640 is identical to the first count wheel 140, except that the first count wheel 1640 does not include the clearance notch 145. The first count wheel 1640 includes a single tooth or protrusion 1642 extending radially outward from its outer circumferential side or outer circumferential surface 1643. In another embodiment thereof (not shown), the first count wheel 1640 may include more than one tooth or protrusion 1642. Therefore, although at least one single tooth or protrusion is required, and a single tooth is considered sufficient, and advantageously simplifies the design and reduces the material cost of the first count wheel 1640, its embodiment may include more than one tooth or protrusion.

[0176] The second counter component 1636 is a sliding element that is intermittently moved by the first count wheel 1640 so that the sliding element moves or translates a fixed amount for each revolution of the first count wheel 1640, as will be described in more detail below. The second counter component 1636 displays the first of a two-digit number of the available dose count. Thus, if Figure 16A As shown, first count wheel 1640 and second count unit 1636 display the number of doses remaining in the inhaler device 100 together.The front or mark display face or mark display surface 1637 of second count unit 1636 comprise the count mark that is arranged thereon, and this count mark comprises " tens " digit.The count mark of second count unit 1636 comprises numeral 3,2,1, and can also comprise single mark SF and double mark DF near the peripheral edge of mark display surface 137.The distance between each mark is the translation amount of second count unit 1636 when first count wheel 1640 per turns one circle.Mark display surface 1637 is a planar structure.

[0177] The display window 104 in the housing 102 is positioned so that a numeral on the first count wheel 1640 and a numeral on the second count unit 1636 are visible in the display window, and are adjacent to each other to form two digits. The numeral reflection that shows on the second count unit 1636 or tracks " tens " digits of residual dose in the inhaler device 100, and the numeral reflection that shows on the first count wheel 1640 or tracks " individual " digits of residual dose. When the quantity of residual dose was lower than 10, the second count unit 1636 would show single mark SF in display window 104, rather than numeral zero or replace numeral zero. For example, in one embodiment, single mark SF could be the colored block that does not have numeral thereon, so that available dose would be about to run out to the user indicating the inhaler device 100. When the quantity of residual dose reached zero, the second count unit 1636 would show double mark DF in display window 104, rather than display numeral. In one embodiment, for example, the dual marking DF may be a colored block without numbers thereon that covers the numbers of the first count wheel 1640 to provide a clear visual feedback to the user that no doses remain in the inhaler device 100. The dual marking DF is configured to cover the numbers of the first count wheel 1640 when no doses remain in the inhaler device 100.

[0178] exist Figure 16A and Figure 16B In the embodiment of the present invention, the units or "ones" digits are arranged in descending order along the circumference of the first count wheel 1640 in a first direction, while the "tens" digits are arranged in descending order in an ascending direction on the second count member 1636, toward the mouthpiece 110 of the inhaler device. Although the counter subassembly described herein displays the number of doses remaining in the inhaler device 100, one of ordinary skill in the art will appreciate that the counter subassembly can be modified to display the number of doses delivered by the inhaler device by reversing the order of the count indicia provided on the counter subassembly.

[0179] like Figure 16A As best shown, the front or indicia display surface 1637 of the second counter member 1636 covers or superimposes a portion of the front or indicia display surface 1641 of the first count wheel 1640. Therefore, the "units" digit on the first count wheel 1640 and the "tens" digit on the second counter member 1636 are not in the same plane. In other words, the "units" digit on the first count wheel 1640 and the "tens" digit on the second counter member 1636 are on different levels, with the "tens" digit being at a higher level relative to the "units" digit and, therefore, closer to the display window 104 of the inhaler device 100.

[0180] Now go to Figure 16B , the structure and operation of the first counting wheel 1640 and the second counting component 1636 will be described in more detail. Figure 16B It is along Figure 16A A cross-sectional view taken along line BB of the counter subassembly is shown, the cross-sectional view being taken midway between the marked display surface and the opposing rear surface of the counter subassembly. The terms "front" and "rear" as used herein are for illustrative purposes only and are intended to refer to the conventional grip of a user when using an inhalation device, wherein the front side of the device includes a display window for the counter mechanism.

[0181] The second counting member 1636 is a generally rectangular non-annular member having a front or indicia display surface 1637 and an opposing rear surface including a plurality of rack teeth 1638, such as Figure 16B The outer side or outer surface 1639 extends between the front and rear surfaces of the second counter component 1636. The outer side 1639 can be stepped, having a smaller width dimension along the rear surface of the second counter component 1636 and a larger width dimension along the front surface of the second counter component. By comparison Figure 16A and Figure 16B The relative width of the middle and outer side surfaces 1639 and the stepped features of the outer side surfaces 1639 are clearly visible.

[0182] A plurality of rack teeth 1638 are formed on an outer side 1639 of the second counter member 136 and do not extend to the front or indicia display surface 1637. In one embodiment, the second counter member 1636 includes four rack teeth 1638, but the number of rack teeth is exemplary and depends on the capacity or total number of doses available in the inhaler device 100. The plurality of rack teeth 1638 are arranged along the longitudinally extending axis L of the inhaler device. A (like Figure 16B ) are aligned longitudinally, and each rack tooth 1638 extends outwardly from the outer side 1639 toward a single tooth 1642 of the first count wheel 1640.

[0183] Second counting member 1636 is positioned adjacent to or near the outer circumferential surface 1643 of first counting wheel 1640, such that a single tooth 1642 on the outer edge of first counting wheel 1640 engages or contacts one of the plurality of rack teeth 1638 of second counting member 1636 once per rotation of first counting wheel 1640, causing second counting member 1636 to translate. In other words, each time first counting wheel 1640 completes a full rotation, single tooth 1642 engages with rack teeth 1638 of second counting member 1636, moving or translating second counting member 1636 a fixed amount. First counting wheel 1640 positions second counting member 1636 by driving it along a linear path. Therefore, with each rotation of first counting wheel 1640, second counting member 1636 linearly moves a fixed distance. Second counting member 1636 is positioned adjacent to or side-by-side with first counting wheel 1640 in the same plane. The first counting wheel 1640 rotates about a first or central axis of the first counting wheel and the second counting member 1630 rotates along a second axis (i.e. the longitudinally extending axis L of the inhaler device). A (like Figure 16B As shown)) axial translation, the second axis is laterally spaced from the first axis. Figure 16A and Figure 16B In the embodiment of the present invention, the first count wheel 1640 is configured to rotate counterclockwise, while the second count member 1636 is configured to move or translate downwardly away from the mouthpiece 110 of the inhaler device. Due to the interaction with the housing 102 (which will be described in more detail below), when the single tooth 1642 of the first count wheel 1640 is not engaged with one of the plurality of rack teeth 1638 of the second count member 1636, the second count member 1636 is at rest and does not translate.

[0184] In this embodiment, the housing 102 of inhaler device 100 includes a flexible arm 1605 extending from its inner surface. Flexible arm 1605 is configured to interact with second counter member 1636, so that when second counter member 1636 is not engaged with first count wheel 1640, the position of second counter member 1636 is maintained. Second counter member 1636 includes a plurality of notches 1607 on its second outside or second outer surface 1609. Second outer surface 1609 is relative to the outer surface 1639 of second counter member 1636. Flexible arm 1605 includes a positioning member 1661 thereon, which is configured to be accommodated in each notch 1607 in a plurality of notches 1607 of second counter member 1636 or to cooperate with notch 1607. Flexible arm 1605 ensures that second counter member 1636 cannot escape its current positioning position before not being subjected to a driving force that is enough to deflect flexible arm 1605. The flexible arm 1605 also helps to maintain consistent positioning of the second counting member 1636 relative to the display window 104 of the inhaler device 100, thereby achieving a more consistent alignment between the first and second digits in a displayed two-digit number.

[0185] Compared with the counter structure that adopts two-wheel parts, counter subassembly 1634 can provide the layout that saves more space.Counter subassembly 1634 does not need to be provided with any type of intermediate component between the counting parts yet.By directly driving the second counting parts 1636 by the first counting wheel 1640, the structure of counter subassembly 1634 is simplified, and the sum of the parts of inhaler device 100 is minimized, to reduce total cost and the complexity of inhaler device 100.In addition, canceling the intermediate component between the counting parts means that there is a shorter tolerance chain in the alignment between the first counting wheel 1640 and the second counting parts 1636, thereby makes the alignment between the first digit and the second digit of the two-digit number that shows more consistent.

[0186] Figure 17 Another embodiment of a counter subassembly 1734 is shown in which the components of the counter subassembly 1734 are arranged in a manner different from the components of the counter subassembly 1634. The counter subassembly 1734 includes a first count wheel or units ring 1740 and a second count component 1636. Except for the differences described herein, the counter subassembly 1734 is the same as the counter subassembly 1634 described above. In this embodiment, the first count wheel 1740 is driven by the dispensing subassembly 120 via gear teeth formed on its outer circumferential side or outer circumferential surface 1743, rather than being driven by gear teeth formed on an inner surface. In other words, in Figure 17 In the embodiment of the present invention, the counting gear (in Figure 17The transmission gear 144 (not visible in the figures) includes external gear teeth, rather than the internal gear teeth of the counter subassemblies 134 and 1634. The transmission gear 144 meshes with the external gear teeth of the first count wheel 1740 and drives the first count wheel 1740 to rotate in the opposite direction. As described above, when the mouth cover 108 is opened, the transmission gear 144 rotates in conjunction with the second bottom sheet take-up gear 128B in the second opposite direction. In this embodiment, the transmission gear 144 cooperates with or directly drives the external gear teeth of the first count wheel 1740 to rotate in the first direction. Therefore, when the mouth cover 108 is opened, the first count wheel 1740 rotates in the first direction.

[0187] Because the first count wheel 1740 is configured to rotate in the first direction, the second count member 1636 moves or translates in an upward direction, toward the mouthpiece 110 of the inhaler device. The "ones" digits are circumferentially arranged on the first count wheel 1640 in a descending order along a second, opposite direction, while the "tens" digits are circumferentially arranged on the second count member 1636 in a descending order along a downward direction, away from the mouthpiece 110 of the inhaler device.

[0188] In addition, a single tooth 1742 extends from the inner circumferential surface 1763 of the first count wheel 1740, rather than from the outer circumferential surface 1743 of the first count wheel 1740. Each time the first count wheel 1740 rotates once, the single tooth 1742 engages or contacts one of the plurality of rack teeth 1638 of the second count member 1636 to cause the second count member 1636 to translate. In other words, each time the first count wheel 1740 completes one full rotation, the single tooth 1742 engages the rack teeth 1638 of the second count member 1636 and moves or translates the second count member 1636 a fixed amount. This arrangement of components having a single tooth 1742 extending from the inner circumferential surface 1763 of the first count wheel 1740 allows the second count member 1636 to move or translate more precisely than the first count wheel 1740. Figure 16A and Figure 16B 1740, thereby potentially reducing the total lateral space occupied by the counter subassembly 1734. In situations where the available space for the dose counter mechanism may be limited, this embodiment provides a space-efficient arrangement of the components of the counter subassembly. In another embodiment thereof (not shown), the first count wheel 1740 may include more than one tooth or protrusion 1742. Thus, while at least a single tooth or protrusion is required and is believed to be sufficient, and advantageously simplifies the design and reduces the material cost of the first count wheel 1740, embodiments thereof may include more than one tooth or protrusion.

[0189] Figure 18A and Figure 18BAnother embodiment of a counter subassembly 1834 that can be used in an inhaler device 100 is depicted in FIG. The counter subassembly 1834 includes a first count wheel or units ring 1840 and a second count component or tens mechanism 1836. Similar to the previous embodiments described herein, the first count wheel 1840 is driven by the dispensing subassembly 120 of the inhaler device 100, rotates once per dose administered at a fixed angle, and is configured to display the second digit of a two-digit count of available doses. The second count component 1836 is intermittently driven by the first count wheel 1840 such that the second count component 1836 rotates a fixed angle for each revolution of the first count wheel 1840. The second count component 1836 displays the first digit of a two-digit count of available doses. Thus, as Figure 18A As shown, the first count wheel 1840 and the second count component 1836 together display the number of doses remaining in the inhaler device 100.

[0190] The front or indicia display face or indicia display surface 1841 of the first counting wheel 1840 includes count indicia disposed thereon, the count indicia including the unit digit or "ones" digit. More specifically, as shown in FIG. Figure 18A As shown, the counting marks of first count wheel 1840 include the numbers 0, 1, 2, 3, 4, 5, 6, 7, 8, and 9, which are distributed in a circular manner near the outer edge of mark display surface 1841. The angle between each number is equal to the angle that first count wheel 1840 rotates during each dose administration. Mark display surface 1841 is a planar structure.

[0191] The front, or indicia display surface, or indicia display surface 1837, of the second counter member 1836 includes indicia, including a tens digit. The indicia on the second counter member 1836 include the numerals 3, 2, and 1, and may also include a single indicia SF and a double indicia DF near the outer edge of the indicia display surface 1837. The angle between each indicia represents the angle of rotation of the second counter member 1836 per rotation of the first counter wheel 1840. The indicia display surface 1837 is a planar structure.

[0192] Similar to aforementioned embodiment as herein described, the display window 104 in the housing 102 is positioned so that a numeral on the first count wheel 1840 and a numeral on the second count unit 1836 are visible in the display window, and are adjacent to each other to form two digits. The numeral reflection that shows on the second count unit 1836 or tracks " tens " digits of residual dose in the inhaler device 100, and the numeral reflection that shows on the first count wheel 1840 or tracks " individual " digits of residual dose. When the quantity of residual dose was lower than 10, the second count unit 1836 would show single mark SF in display window 104, rather than numeral zero or replace numeral zero. For example, in one embodiment, single mark SF can be the colored block that does not have numeral thereon, so that available dose is about to run out to the user indication in the inhaler device 100. When the quantity of residual dose reached zero, the second count unit 1836 would show double mark DF in display window 104, rather than display numeral. In one embodiment, for example, the dual marking DF may be a colored block without numbers thereon that covers the numbers of the first count wheel 1840 to provide a clear visual feedback to the user that no doses remain in the inhaler device 100. The dual marking DF is configured to cover the numbers of the first count wheel 1840 when no doses remain in the inhaler device 100.

[0193] exist Figure 18A and Figure 18B In the embodiment of FIG. 1 , the units or "ones" digits are circumferentially arranged in descending order along a second, opposite direction on the first count wheel 1840, and the "tens" digits are arranged in descending order along a second, opposite direction on the second count member 1836. Although the counter subassembly described herein displays the number of doses remaining in the inhaler device 100, one of ordinary skill in the art will appreciate that the counter assembly can be modified to display the number of doses delivered by the inhaler device by reversing the order of the count indicia provided on the counter subassembly.

[0194] like Figure 18A As shown, the front or indicia display surface 1837 of the second counter member 1836 overlaps or covers a portion of the front or indicia display surface 1841 of the first count wheel 1840. Therefore, the "units" digit on the first count wheel 1840 and the "tens" digit on the second counter member 1836 are not in the same plane. In other words, the "units" digit on the first count wheel 1840 and the "tens" digit on the second count member 1836 are in different planes or levels, with the "tens" digit being at a higher position relative to the "units" digit and thus closer to the display window 104.

[0195] Now go to Figure 18B , the structure and operation of the first counting wheel 1840 and the second counting component 1836 will be described in more detail. Figure 18B It is along Figure 18A 1 and 2. A cross-sectional view taken along line BB of FIG. 1 is provided adjacent the opposite rear surface of the counter subassembly. The terms "front" and "rear" are used herein for illustrative purposes only and are intended to refer to the conventional grip of a user when using an inhalation device, wherein the front side of the device includes a display window for the counter mechanism.

[0196] The first count wheel 1840 is an annular or ring-shaped member having a front or indicia display surface 1841 and an opposing rear surface that includes a count gear 1848. A single tooth 1842 extends from an inner circumferential surface 1863 of the first count wheel 1840 adjacent to the count gear 1848. The count gear 1848 may be integrally formed on or attached to the first count wheel 1840. In another embodiment thereof (not shown), the first count wheel 1840 may include more than one tooth or protrusion 1842. Thus, while at least one single tooth or protrusion is required and is believed to be sufficient, and advantageously simplifies the design and reduces the material cost of the first count wheel 1840, embodiments thereof may include more than one tooth or protrusion.

[0197] The second counter member 1836 is configured to rotate about a pivot point 1847. The second counter member 1836 is a non-annular or partially disc-shaped member having a front or indicia display surface 1837 and an opposing rear surface that includes a second counter gear 1865. The second counter gear 1865 can be integrally formed with or attached to the second counter member 1836. The second counter gear 1865 includes a plurality of gear teeth on its outer circumferential surface 1839, each of which extends radially outward. The second counter gear 1865 of the second counter member 1836 is not coaxially disposed with the counter gear 1848 of the first counter wheel 1840.

[0198] First count wheel 1840 is indirectly driven by second bottom sheet take-up gear 128B of dispensing subassembly 120, causing first count wheel 1840 to rotate a fixed angle each time a dose is dispensed. More specifically, in this embodiment, transmission gear 144 engages with or directly drives count gear 1848 of first count wheel 1840, driving first count wheel 1840 to rotate in the reverse direction. As described above, when mouth cover 108 is opened, transmission gear 144 rotates in conjunction with second bottom sheet take-up gear 128B in the second, reverse direction. Therefore, in this embodiment, transmission gear 144 engages with or directly drives the external gear teeth of first count wheel 1840 to rotate in the first direction. Therefore, when mouth cover 108 is opened, first count wheel 1840 rotates in the first direction.

[0199] The second counting member 1836 is positioned adjacent to or in close proximity to the inner circumferential surface 1863 of the first counting wheel 1840 so that the single tooth 1842 of the first counting wheel 1840 engages the second counting gear 1865 of the second counting member 1836 once for each rotation of the first counting wheel 1840, thereby intermittently rotating the second counting member 1836. In other words, each time the first counting wheel 1840 completes one full rotation, the single tooth 1842 engages the second counting gear 1865 of the second counting member 1836 and turns or rotates the second counting member 1836 a fixed amount. Therefore, the second counting member 1836 rotates a fixed amount for each rotation of the first counting wheel 1840. Since the first counting wheel 1840 directly drives the second counting member 1836 and the second counting gear 1865 is disposed within the first counting wheel 1840, the second counting member 1836 rotates in the same direction as the first counting wheel 1840. Figure 18A and Figure 18B In the embodiment of the present invention, each of the first counting wheel 1840 and the second counting member 1836 is configured to rotate in a first direction. When the single tooth 1842 of the first counting wheel 1840 is not engaged with the second counting gear 1865 of the second counting member 1836, the second counting member 1836 is in a stationary state and does not rotate.

[0200] Second counting member 1836 is disposed within first counting wheel 1840 and lies in the same plane as first counting wheel 1840, but rotates on a different rotational axis than first counting wheel 1840. In other words, while first counting wheel 1840 rotates about a first axis, second counting member 1836 rotates about a second axis, which is parallel to and spaced from the first axis. Therefore, second counting member 1836 rotates once about a different rotational axis in a fixed pattern and in the same direction for each rotation of first counting wheel 1840. In this embodiment, the rotational axis of second counting member 1836 lies within the inner diameter of first counting wheel 1840, which is defined by the inner circumference of first counting wheel 1840. Placing second counting member 1836 on a different rotational axis than first counting wheel 1840 allows the markings on second counting member 1836 to be arranged at a larger radius, facilitating the placement of larger counting markings, which improves readability.

[0201] Compared with above-mentioned counter subassembly 134, the arrangement of the parts of counter subassembly 1834 has potentially reduced the overall lateral space that counter subassembly 1834 occupies.For the situation that the available space of dose counter mechanism may have restriction, this embodiment provides the space efficient arrangement of the parts of counter subassembly.Counter subassembly 1834 also does not need to be provided with any type of intermediate component between the counting parts.By directly driving the second counting part 1836 by the first count wheel 1840, the structure of counter subassembly 1834 is simplified, and the total component quantity of inhaler device 100 is minimized, thereby reduces total cost and the complexity of inhaler device 100.In addition, omitting the intermediate component between the counting parts means that there is a shorter tolerance chain in the alignment between the first count wheel 1840 and the second counting part 1836, thereby makes more consistent between the first digit and the second digit of the two-digit number of display.

[0202] In this embodiment, the back plate of counter subassembly 1845 comprises flexible arm 1805.Flexible arm 1805 is configured to interact with second counting unit 1836, to keep the position of second counting unit 1836 when second counting unit 1836 does not mesh with first count wheel 1840.Comprise locator 1861 on the flexible arm 1805, locator 1861 is configured to be contained in the notch between the adjacent gear teeth that is formed at second counter gear 1865 or cooperates with the notch.Flexible arm 1805 guarantees that second counting unit 1836 can't break away from its current positioning position before not being subjected to the driving force that is enough to make flexible arm 1805 deflect.Flexible arm 1805 also helps to keep the consistent position of second counting unit 1836 with respect to the display window 104 of inhaler device 100, thereby makes the more consistent of aiming between first digit and the second digit in the two digits of demonstration.

[0203] Although, as mentioned above, it is advantageous to omit intermediate components between the components of the counter subassembly, the use of intermediate components may provide greater flexibility in the design of the counter subassembly with respect to different gear ratios and component position arrangements. Since the design of the dose counter mechanism may depend on other elements of the inhaler, such as the design of the housing and the layout of the dispensing subassembly 120, the increased flexibility in the design of the counter subassembly may help find the arrangement that best suits the other design elements. Figure 19A and Figure 19BAnother embodiment of a counter subassembly 1934 including an intermediate component is shown. Counter subassembly 1934 includes a first count wheel or units ring 1940 and a second count component 1936. Aside from the differences described herein, counter subassembly 1934 is identical to counter subassembly 1834 described above. In this embodiment, an intermediate count gear 1967 is positioned between a first count gear 1948 formed by the first count wheel 1940 and a second count gear 1965 formed by the second count component 1936. Intermediate count gear 1967 transmits the rotation of the first count wheel 1940 to the second count component 1936, rather than directly meshing the two components.

[0204] Similar to the first count wheel 1840 described above, the first count wheel 1940 is driven by the second bottom sheet take-up gear 128B in the dispensing subassembly 120, causing the first count wheel 1940 to rotate a fixed angle each time a dose is dispensed. As described above, when the mouth cover 108 is opened, the transmission gear 144 rotates in conjunction with the second bottom sheet take-up gear 128B in the second, opposite direction. Therefore, in this embodiment, the transmission gear 144 engages with or directly drives the external gear teeth of the external gear 1948 of the first count wheel 1940 to rotate in the first direction. Therefore, when the mouth cover 108 is opened, the first count wheel 1940 rotates in the first direction.

[0205] Intermediate counter gear 1967 is positioned adjacent to or in close proximity to the inner circumferential surface 1963 of first counter wheel 1940, such that a single tooth 1942 of first counter wheel 1940 engages intermediate counter gear 1967 once for each rotation of first counter wheel 1940. Intermediate counter gear 1967 is also located adjacent to second counter gear 1965 of second counter member 1936, such that second counter gear 1965 rotates together with intermediate counter gear 1967. Second counter gear 1965 of second counter member 1936 is constantly meshed with intermediate counter gear 1967, so whenever intermediate counter gear 1967 rotates, second counter member 1936 rotates. Therefore, whenever first counter wheel 1940 completes one full rotation, single tooth 1942 engages intermediate counter gear 1967, and second counter member 1936 rotates or turns a fixed amount. Thus, for each rotation of first counter wheel 1940, second counter member 1936 rotates a fixed amount. Therefore, in this embodiment, the first counting wheel 1940 drives the second counting component 1936 indirectly through the intermediate counting gear 1967. Figure 19A and Figure 19BIn an embodiment, each of the first count wheel 1940 and the intermediate count gear 1967 is configured to rotate in a first direction, and the second count component 1936 is configured to rotate in a second, opposite direction. When the single tooth 1942 of the first count wheel 1940 is not engaged with the intermediate count gear 1967, the second count component 1936 is in a stationary state and does not rotate. In another embodiment thereof (not shown), the first count wheel 1940 may include more than one tooth or protrusion 1942. Therefore, although at least one single tooth or protrusion is required and a single tooth is considered sufficient and advantageously simplifies the design and reduces the material cost of the first count wheel 1940, embodiments thereof may include more than one tooth or protrusion.

[0206] exist Figure 19A and Figure 19B In the embodiment of the present invention, the second counting member 1936 rotates in the opposite direction to the first counting wheel 1940 and the intermediate counting gear 1967. Figure 19A As shown, the units or "ones" digits are circumferentially arranged on the first count wheel 1940 in descending order in a second, opposite or counterclockwise direction, while the "tens" digits are arranged on the second count member 1836 in descending order in a first or clockwise direction.

[0207] Figures 20A-20M Another embodiment of a counter subassembly 2034 that may be used within the inhaler device 100 is shown in FIG. Figure 20A The counter subassembly 2034 is shown after assembly. Figure 20B An exploded view of the components of the counter subassembly 2034 is shown. The counter subassembly 2034 includes a first count wheel or units ring 2040 and a second count wheel or tens ring 2036. Similar to the previous embodiments described herein, the first count wheel 2040 is driven by the dispensing subassembly 120 of the inhaler device 100, rotates a fixed angle each time a dose is administered, and is configured to display the second digit of a two-digit number of available doses. The second count wheel 2036 is intermittently driven by the first count wheel 2040 such that the second count wheel 2036 rotates a fixed angle for each revolution of the first count wheel 2040. The second count wheel 2036 displays the first digit of a two-digit number of available doses. Thus, as Figure 20A As shown, the first count wheel 2040 and the second count wheel 2036 together display the number of doses remaining in the inhaler device 100. In addition to the first count wheel 2040 and the second count wheel 2036, the counter subassembly 2034 includes a back plate 2073, a cover 2075 and a transmission gear 2044. Figure 20AWhen assembled as shown, first count wheel 2040 , second count wheel 2036 , and drive gear 2044 are disposed between back plate 2073 and cover 2075 such that cover 2075 overlaps or covers first count wheel 2040 , second count wheel 2036 , and drive gear 2044 .

[0208] The front or indicia display face or indicia display surface 2041 of the first counting wheel 2040 includes count indicia disposed thereon, the count indicia including the unit digit or "ones" digit. More specifically, as shown in FIG. Figure 20B As best shown in the exploded view of FIG, the count indicia of first count wheel 2040 include the numbers 0, 1, 2, 3, 4, 5, 6, 7, 8, and 9, which are arranged in a circular manner near the peripheral edge of the indicia display surface 2041. The angle between each number is equal to the angle that first count wheel 2040 rotates each time a dose is obtained. Indicia display surface 2041 is a planar structure.

[0209] The front, or indicia display surface, or indicia display surface 2037, of second count wheel 2036 includes count indicia, including the tens digit. The count indicia of second count wheel 2036 include the numerals 3, 2, and 1, and may also include a single indicia SF and a double indicia DF near the outer edge of indicia display surface 2037. The angle between each indicia represents the angle of rotation of second count wheel 2036 per rotation of first count wheel 2040. Indicia display surface 2037 is a planar structure.

[0210] Similar to the aforementioned embodiment described herein, the display window 2004 in the housing 102 is positioned so that a numeral on the first count wheel 2040 and a numeral on the second count wheel 2036 are visible in the display window, and are adjacent to each other to form two digits. In this embodiment, the display window 2004 is normally circular, and this will be described in more detail herein. The numerals shown on the second count wheel 2036 reflect or track the "tens" digits of the remaining dose in the inhaler device 100, while the numerals shown on the first count wheel 2040 reflect or track the "units" digits of the remaining dose. When the quantity of the remaining dose was lower than 10, the second count wheel 2036 would display a single mark SF in the display window 2004, rather than the numeral zero. For example, in one embodiment, the single mark SF could be a colored block without a numeral thereon, to indicate to the user that they are nearing the end point of the available dose in the inhaler device 100. When the quantity of the remaining dose reached zero, the second count wheel 2036 would display a double mark DF in the display window 2004, rather than displaying a numeral. In one embodiment, for example, the dual marking DF may be a colored block without numbers thereon that covers the numbers of the first count wheel 2040 to provide a clear visual feedback to the user that no doses remain in the inhaler device 100. The dual marking DF is configured to cover the numbers of the first count wheel 2040 when no doses remain in the inhaler device 100.

[0211] exist Figures 20A-20M In the embodiment of the present invention, the units or "ones" digits are circumferentially arranged in descending order in a first direction on the first count wheel 2040, while the "tens" digits are arranged in descending order in a second, opposite direction on the second count wheel 2036. Although the counter subassembly is described herein as displaying the number of doses remaining in the inhaler device 100, one of ordinary skill in the art will appreciate that the counter subassembly can be modified to display the number of doses delivered by the inhaler device by reversing the order of the count indicia provided on the counter subassembly.

[0212] like Figure 20C As shown, the front or indicia display surface 2047 of the second count wheel 2036 overlaps a portion of the front or indicia display surface 2041 of the first count wheel 2040. Therefore, the "units" digit on the first count wheel 2040 and the "tens" digit on the second count wheel 2036 are not in the same plane. In other words, the "units" digit on the first count wheel 2040 and the "tens" digit on the second count wheel 2036 are in different planes or levels, with the "tens" digit being at a higher position relative to the "units" digit and thus closer to the display window 2004.

[0213] The structure and operation of the first counting wheel 2040 and the second counting wheel 2036 will be described in more detail below. Figure 20F 、 Figure 20I 、 Figure 20K 、 Figure 20L and Figure 20M As shown, the first count wheel 2040 is an annular or ring-shaped member having a front or indicia display surface 2041 and an opposing rear surface that includes a first count gear 2048. The first count gear 2048 can be integrally formed with or attached to the first count wheel 140. An outer circumferential surface or outer circumferential side surface 2043 extends between the front and rear surfaces of the first count wheel 140. The outer circumferential side surface 2043 can be stepped, having a smaller diameter along the rear surface of the first count wheel 2040 and a larger diameter along the front surface of the first count wheel 2040. Thus, the outer diameter of the indicia display surface 2041 of the first count wheel 2040 is larger than the outer diameter of the first count gear 2048.

[0214] The front or indicia display surface 2041 of the first count wheel 2040 includes a single tooth or protrusion 2042 extending radially outward from an outer circumferential side 2043. In another embodiment thereof (not shown), the first count wheel 2040 may include more than one tooth or protrusion 2042. Thus, while at least one single tooth or protrusion is required and is believed to be sufficient, and advantageously simplifies the design and reduces the material cost of the first count wheel 2040, embodiments thereof may include more than one tooth or protrusion.

[0215] The second count wheel 2036 is an annular or ring-shaped member having a front or indicia display surface 2037 and an opposing rear surface including a second count gear 2065, as shown. Figure 20I As shown. The second counting gear 2065 can be integrally formed with the second counting wheel 2036 or attached to the second counting wheel 2036. The second counting gear 2065 includes a plurality of gear teeth on its outer circumferential surface, each of which extends radially outward. The second counting gear 2065 of the second counting wheel 2036 is not coaxially arranged with the counting gear 2048 of the first counting wheel 2040.

[0216] like Figure 20CAs best shown, in this embodiment, the second count wheel 2036 overlaps or covers a portion of the first count wheel 2040, and the second count wheel 2036 includes a cutout 2069 such that the "units" digit of the first count wheel 2040 is visible through the cutout 2069 of the second count wheel 2036. The geometry of the cutout 2069 is exemplary and includes a continuous groove disposed radially inward of the count marks of the second count wheel 2036, but may alternatively include a plurality or series of holes such that a hole is disposed radially inward of each count mark of the second count wheel 2036. For each rotation of the first count wheel 2040, a single tooth 2042 of the first count wheel 2040 engages the second count gear 2065 of the second count wheel 2036 once, thereby intermittently rotating the second count wheel 2036. In other words, each time first count wheel 2040 completes a full rotation, single tooth 2042 engages second count gear 2065 of second count wheel 2036, rotating or turning second count wheel 2036 a fixed amount. Thus, for every full rotation of first count wheel 2040, second count wheel 2036 rotates a fixed amount. Second count wheel 2036 rotates on a different rotational axis than first count wheel 2040. In other words, first count wheel 2040 rotates about a first axis, while second count wheel 2036 rotates about a second axis, which is parallel to and spaced from the first axis. Placing second count wheel 2036 on a different rotational axis relative to first count wheel 2040 allows the markings on second count wheel 2036 to be arranged at a larger radius, facilitating the placement of larger count markings, which improves readability.

[0217] like Figure 20C As shown, the spacing between the count marks on the second count wheel 2036 is greater than the spacing between the count marks on the first count wheel 2040. The increased spacing between the count marks on the second count wheel 2036 reduces the risk of a user viewing adjacent marks on the second count wheel 2036 through the display window 2004. In addition, because the second count wheel 2036 overlaps or covers a portion of the first count wheel 2040, the second count wheel 2036 covers adjacent marks on the first count wheel 2040 and reduces the risk of a user viewing adjacent marks on the first count wheel 2040 through the display window 2004. Reducing the visibility of adjacent count marks on the count wheel helps provide greater flexibility in the shape of the display window 104. For example, Figures 20A-20M As shown in the embodiment of the inhaler device, the display window 2004 of the inhaler device is circular rather than rectangular, which can improve the visibility of the counting marks when the inhaler device is viewed from above or below the display window (i.e., when the inhaler device is viewed at an angle that is not perpendicular to the front of the inhaler device).

[0218] Compared to the counter subassembly 134 described above, the arrangement of the components of the counter subassembly 2034 potentially reduces the overall lateral space occupied by the counter subassembly 2034. For situations where the available space for a dose counter mechanism may be limited, this embodiment provides a space-efficient arrangement of the components of the counter subassembly. Specifically, because the second count wheel 2036 overlaps or covers a portion of the first count wheel 2040, the axes of rotation of the count wheels are closer together than with the counter subassembly 134, thereby reducing the overall width of the counter subassembly and / or maximizing the size of the count wheel (and count indicia) within the available width or space of the counter subassembly.

[0219] Counter subassembly 2034 does not need to be provided with any type of intermediate component between the count wheels.By directly driving the second count wheel 2036 by the first count wheel 2040, the structure of counter subassembly 2034 is simplified, and the total component quantity of inhaler device 100 is minimized, to reduce total cost and the complexity of inhaler device 100.In addition, omitting the intermediate component between the count wheels means that there is a shorter tolerance chain in the alignment between the first count wheel 2040 and the second count wheel 2036, makes more consistent between the first and second of the two-digit numbers that show.

[0220] refer to Figure 20D and Figure 20E , lens 2071 is set in the front of the count mark in the display window 2004 zones.When observing the inhaler device from the top or bottom of the display window (when observing with the angle that is not perpendicular to the inhaler device front), lens 2071 can improve the visibility of count mark.The degree of depth of lens 2071 is through maximizing design to reduce the visual perception distance between the front of the inhaler housing and the count wheel. In addition, as Figure 20E As shown, lens 2071 can be a non-planar lens to reduce visibility in the edge area of ​​the window. In one embodiment, the peripheral edge of lens 2071 can be frosted to reduce visibility in the area of ​​display window 2004 away from the target counting mark. In one embodiment, lens 2071 can also be integrated with a magnification function to visually magnify the height of the counting mark.

[0221] Reference Figures 20F-20H In this embodiment, the first counting wheel 2040 is driven by the first bottom sheet winding gear 128A of the dispensing subassembly 120, rather than by the second bottom sheet winding gear 128B. More specifically, Figure 20FIn this embodiment, best shown in FIG, a transmission gear 2044 is attached to opposite ends of the first main shaft 129A of the first bottom sheet take-up gear 128A, such that the transmission gear 2044, the first main shaft 129A, and the first bottom sheet take-up gear 128A rotate simultaneously as a single, integrated assembly. When the mouth cover 108 is opened, the transmission gear 2044 rotates in conjunction with the first bottom sheet take-up gear 128A in a first direction. The transmission gear 2044 cooperates with or directly drives the first intermediate gear 2048 to rotate in a second, opposite direction. Thus, in this embodiment, the first counter gear 2048 rotates in a direction opposite to the transmission gear 2044, and the first counter wheel 2040 rotates in the second, opposite direction when the mouth cover 108 is opened. Similar to the previous embodiment, the first counter wheel 2040 rotates a fixed angle each time a dose is dispensed.

[0222] like Figure 20I As best shown, the first count wheel 2040 directly drives the second count wheel 2036 via the interaction between the single tooth 2042 and the second count gear 2065, causing the second count wheel 2036 to rotate in the opposite direction of the first count wheel 2040. Thus, the first count wheel 2040 rotates in the second opposite direction (i.e., counterclockwise), while the second count wheel 2036 rotates in the first direction (i.e., clockwise). When the single tooth 2042 of the first count wheel 2040 is not engaged with the second count gear 2065 of the second count wheel 2036, the second count wheel 2036 is stationary and does not rotate. More specifically, in this embodiment, the second flexible arm 2093 is integrally formed on or attached to the back plate 2073 and is configured to interact with the second count gear 2065 disposed on the rear surface of the second count wheel 2036. The second flexible arm 2093 is configured to interact with the second counter member 2036 to maintain the position of the second counter member 2036 when the second counter member 2036 is not engaged with the first count wheel 2040. In other words, the second flexible arm 2093 maintains or fixes the alignment of the second count wheel 2036 when not driven by the first count wheel 2040. Thus, the second flexible arm 2093 reduces variations in the positions of the count marks on the second count wheel 2036 that may be caused by component tolerances. The second flexible arm 2093 includes a positioning member 2061 thereon that is configured to extend between adjacent gear teeth of the second count gear 2065 of the second counter member 2036. The second flexible arm 2093 ensures that the second counter member 2036 cannot move from its current positioning position without being subjected to a force sufficient to deflect the second count wheel 2040. The second flexible arm 2093 also helps to maintain a consistent position of the second counter member 2036 relative to the display window 2004 of the inhaler device, thereby providing more consistent alignment between the first and second digits of a displayed two-digit number.

[0223] In this embodiment, to ensure the rotational accuracy of the counting subassembly 2034 when the spout cover 108 is opened, a stop structure is also provided in the counting subassembly 2034. This stop structure is configured to drive the first counting wheel 2040 to its final position when the first counting wheel 2040 is driven by the dispensing subassembly 120 to rotate within a certain angular range close to the target nominal position of the first counting wheel 2040. However, the stop structure does not have sufficient force to simultaneously rotate the entire gear train connected to the first counting wheel 2040 (i.e., the gear train of the dispensing subassembly 120). The stop structure can accommodate tolerance variations in the gear train of the dispensing subassembly 120.

[0224] More specifically, refer to Figure 20I-20M The stop structure includes a first flexible arm 2077 that is integrally formed on or attached to the back plate 2073 and is configured to interact with a positioning wheel 2079 disposed on the rear surface of the first count wheel 2040. The positioning wheel 2079 can be coaxially disposed with the first intermediate gear 2048. The positioning wheel 2079 includes a plurality of radially extending circular protrusions 2081, with notches or gaps 2083 formed between each pair of adjacent circular protrusions 2081. The first flexible arm 2077 includes a positioning member 2085 that is configured to be received within the gaps 2083 of the positioning wheel 2079.

[0225] The first flexible arm 2077 is configured to pull or rotate the first counting wheel 2040, thereby controlling the position of the first counting wheel 2040. Figure 20L , the rotation of the first counting wheel 2040 is driven by the mouth cover 108 and the dispensing subassembly 120 until the target nominal position θ°, and then the rotation of the first counting wheel 2040 is driven by the first flexible arm 2077. More specifically, when the mouth cover 108 is opened and the first counting wheel 2040 rotates to θ° away from the final position, the transmission gear 2044 rotates together with the first bottom sheet winding gear 128A in the first direction (i.e., clockwise), thereby causing the first counting wheel 2040 to rotate in the second opposite direction (i.e., counterclockwise) as described above. After the first counting wheel 2040 reaches the target nominal position θ°, since the positioning member 2085 of the first flexible arm 2077 is biased to be accommodated in the notch 2083 of the positioning wheel 2079, the first flexible arm 2077 causes the first counting wheel 2040 to further rotate in the second opposite direction (i.e., counterclockwise). As Figure 20MAs shown, when the positioning member 2085 of the first flexible arm 2077 moves into the notch 2083 of the positioning wheel 2079, the first flexible arm 2077 pulls the first counting wheel 2040 to rotate in the second direction (i.e., counterclockwise) to the final position, thereby causing the transmission gear 2044 to start rotating in the first direction (i.e., clockwise) before or before the first film winding gear 128A starts rotating. Therefore, the first flexible arm 2077 drives and accurately fixes the first counting wheel 2040 at the target position, and this process is independent of the tolerance chain of the mouthpiece cover 108 and the dispensing subassembly 120 leading to the first counting wheel 2040.

[0226] In order for the stop structure to operate correctly, the inhaler device must include a suitably large gap or backlash to allow the counter subassembly 2034 to rotate forward (i.e., in the second, opposite direction) in the absence of the gear train of the dispensing subassembly 120. Figures 20A-20M In the embodiment, a suitable tooth gap or clearance is provided at the interface between the first bottom sheet take-up gear 128A and the transfer gear 2044. Figures 20F-20H As described above, the drive gear 2044 is attached to opposite ends of the first main shaft 129A of the first bottom sheet winding gear 128A. More specifically, the first main shaft 129A includes a pair of upright members or posts 2087 having free or unattached ends 2089. The free or unattached ends 2089 of the posts 2087 are connected to the relatively large holes 2091 of the drive gear 2044. The loose fit between the posts 2087 and the holes 2091 provides appropriate tooth clearance or clearance for proper operation of the stop structure. More specifically, when the drive gear 2044 rotates in a first direction (i.e., clockwise) with the first bottom sheet winding gear 128A, the posts 2087 of the first bottom sheet winding gear 128A contact the drive gear 2044 at the drive surface 2091A of the hole 2091. Conversely, when the first flexible arm 2077 pulls the first counting wheel 2040 to rotate in the second direction (i.e., counterclockwise) to the final position, and thereby causes the transmission gear 2044 to rotate in the first direction ahead of (or earlier than) the first film winding gear 128A, sufficient clearance will be provided inside the hole 2091 of the transmission gear 2044 to allow the free end or unattached end 2089 of the column 2087 to move toward the non-driving surface 2099.

[0227] Although the stop structure including the first flexible arm 2077 is only Figures 20A-20M However, it is obvious to those skilled in the art that the stop structure can be incorporated into the counter subassembly 134, 1534, 1634, 1734 and / or 1834 to ensure the rotation accuracy of the corresponding first counting wheel.

[0228] Although various embodiments of the present invention have been described above, it should be understood that the foregoing is presented by way of example and illustration only and is not intended to limit the present invention. Those skilled in the art will appreciate that various changes may be made to its form and details without departing from the spirit and scope of the present invention. Therefore, the breadth and scope of the present invention should not be limited by the above-described exemplary embodiments, but should only be limited by the appended claims and their equivalents. In addition, it should be understood that the various features of each embodiment described in this specification, as well as the various features in the cited literature, may be used in combination with the features of any other embodiment. All patents and publications described herein are incorporated herein by reference in their entirety.

Claims

1. A dry powder inhaler device comprising: an actuator for operating a dispensing mechanism of the dry powder inhaler device; a first count wheel configured to be rotated by the dispensing mechanism, wherein the first count wheel includes a single tooth extending radially outwardly on an outer circumferential surface or an outer circumferential side of the first count wheel; and a second counting member disposed adjacent to an outer circumferential surface or outer circumferential side of the first counting wheel, wherein the second counting member includes a plurality of notches on an outer surface or outer side of the second counting member, each notch extending radially inwardly and each notch configured to cooperate with the single tooth; wherein a single tooth of the first count wheel engages with one of the plurality of notches of the second count member once per rotation of the first count wheel to intermittently rotate the second count member, the first count wheel and the second count member being configured to rotate in opposite directions, and The first counter wheel and the second counter member together display the number of doses remaining in the inhaler device or the number of doses delivered by the inhaler device.

2. A dry powder inhaler device according to claim 1, wherein the actuator is a mouthpiece cover.

3. The dry powder inhaler device of claim 1, wherein the first count wheel rotates about a first axis and the second count member rotates about a second axis, the second axis being parallel to and spaced apart from the first axis.

4. The dry powder inhaler device of claim 1 , wherein the plurality of notches comprises four notches.

5. The dry powder inhaler device of claim 1 , wherein a segmented portion of the outer surface or outer side surface of the second counting member extending between two adjacent notches among the plurality of notches is concave, and the segmented portion forms an arcuate recess that matches the outer circumferential surface or outer circumferential side surface of the first counting wheel.

6. A dry powder inhaler device according to claim 1, wherein the outer surface or outer side of the second counting component includes a plurality of segmented portions, each of the segmented portions extending between two adjacent notches in the plurality of notches, and wherein each of the segmented portions is concave, and the segmented portions form an arcuate recess that coincides with the outer circumferential surface or outer circumferential side of the first count wheel.

7. The dry powder inhaler device of claim 1, wherein the first count wheel is an annular member.

8. The dry powder inhaler device of claim 1, wherein the second counting member is a non-annular member.

9. The dry powder inhaler device of claim 1 , wherein the marking display surface of the first count wheel includes a “ones” digit disposed thereon, and the marking display surface of the second count component includes a “tens” digit disposed thereon.

10. The dry powder inhaler device of claim 9, wherein the marking display surface of the first count wheel and the marking display surface of the second count member are located in the same plane.

11. The dry powder inhaler device of claim 9, wherein the marking display surface of the first count wheel and the marking display surface of the second count member are not located in the same plane, and the marking display surface of the second count member is closer to the display window of the inhaler device than the marking display surface of the first count wheel.

12. The dry powder inhaler device of claim 1, wherein the second count component is configured to rotate in a first direction and the first count wheel is configured to rotate in a second, opposite direction.

13. The dry powder inhaler device of claim 1, wherein the second counting component includes a single mark in place of the number zero, the single mark being a colored block with no numbers thereon.

14. The dry powder inhaler device of claim 1 , wherein the second counting component comprises a dual marking, the dual marking being a colored block without numbers thereon, and wherein the dual marking is configured to cover numbers of the first count wheel when no doses remain in the inhaler device.

15. The dry powder inhaler device of claim 1, wherein an outer circumferential surface or side surface of the first count wheel is substantially circular, and a gap is provided around the single tooth.

16. The dry powder inhaler device of claim 1, wherein the second counter member is in a rest state when a single tooth of the first count wheel is not engaged within one of the plurality of notches of the second counter member.

17. The dry powder inhaler device of claim 1 , wherein the first count wheel comprises a positioning wheel having a plurality of notches, and wherein the dry powder inhaler device further comprises a housing and a flexible arm extending from the housing, the flexible arm comprising a positioning member thereon, the positioning member being configured to be received within one of the plurality of notches of the first count wheel.

18. The dry powder inhaler device of claim 17, wherein the flexible arm is configured to drive the first count wheel and secure the first count wheel in a target position.

19. The dry powder inhaler device of claim 1 , wherein the dry powder inhaler device further comprises a housing and a flexible arm extending from the housing, the flexible arm including a locator thereon, the locator configured to be received in one of the plurality of notches of the second counting component.

20. A dry powder inhaler device comprising: an actuator for operating a dispensing mechanism of the dry powder inhaler device; a first count wheel configured to be rotated by the dispensing mechanism, wherein the first count wheel includes a single tooth extending radially outward from a circumferential surface or side of the first count wheel; and a second counting member disposed adjacent to the first counting wheel, wherein the second counting member includes a plurality of rack teeth on an outer surface or exterior side of the second counting member, the plurality of rack teeth being longitudinally aligned and extending outwardly in a direction toward a single tooth of the first counting wheel, wherein a single tooth of the first counting wheel engages with one of the plurality of rack teeth of the second counting member once per complete rotation of the first counting wheel to intermittently drive the second counting member to translate, and The first counter wheel and the second counter member together display the number of doses remaining in the inhaler device or the number of doses delivered by the inhaler device.

21. The dry powder inhaler device of claim 20, wherein the actuator is a mouthpiece cover.

22. The dry powder inhaler device of claim 20, wherein the plurality of rack teeth comprises four rack teeth.

23. The dry powder inhaler device of claim 20, wherein the first count wheel rotates about a first axis of the first count wheel and the second count member translates axially along a longitudinally extending axis of the inhaler device.

24. The dry powder inhaler device of claim 20, wherein The longitudinally extending axis of the inhaler device and the first axis are laterally spaced from each other.

25. The dry powder inhaler device of claim 20, wherein the first count wheel is an annular member.

26. The dry powder inhaler device of claim 20, wherein the second counting member is a non-annular member.

27. The dry powder inhaler device of claim 20, wherein the marking display surface of the first count wheel includes a "ones" digit disposed thereon, and the marking display surface of the second count component includes a "tens" digit disposed thereon.

28. A dry powder inhaler device according to claim 27, wherein the marking display surface of the first count wheel and the marking display surface of the second count member are not located in the same plane, and the marking display surface of the second count member is closer to the display window of the inhaler device than the marking display surface of the first count wheel.

29. The dry powder inhaler device of claim 20, wherein the second counting component includes a single mark in place of the number zero, the single mark being a colored block without a number thereon.

30. The dry powder inhaler device of claim 20, wherein the second counter component comprises a dual marking, the dual marking being a colored block without numbers thereon, and wherein the dual marking is configured to cover the units digit of the first count wheel when no doses remain in the inhaler device.

31. The dry powder inhaler device of claim 20, wherein the second counting component is in a rest state when the single tooth is not engaged within one of the plurality of rack teeth.

32. The dry powder inhaler device of claim 31 , wherein the second counter component comprises a plurality of notches.

33. A dry powder inhaler device according to claim 32, wherein the first count wheel and the second count component are disposed within a housing of the dry powder inhaler device, and wherein the housing includes a flexible arm extending from an inner surface of the housing, the flexible arm including a locating member located thereon, the locating member being configured to be received within one of a plurality of notches in the second count component.

34. A dry powder inhaler device according to claim 33, wherein the outer surface or outer side of the second counting component including the plurality of rack teeth is a first outer surface or first outer side, and the plurality of notches are arranged on a second outer surface or second outer side opposite to the first outer surface or first outer side.

35. The dry powder inhaler device of claim 20, wherein the circumferential surface or circumferential side of the first count wheel is an outer circumferential surface or outer circumferential side.

36. The dry powder inhaler device of claim 20, wherein the circumferential surface or circumferential side of the first count wheel is an inner circumferential surface or inner circumferential side.

37. A dry powder inhaler device comprising: an actuator for operating a dispensing mechanism of a dry powder inhaler device; a first count wheel configured to be rotated by the dispensing mechanism, wherein the first count wheel includes a single tooth extending radially inward from an inner circumferential surface or inner circumferential side of the first count wheel; and a second counting member, the second counting member being at least partially disposed within the first counting wheel, wherein the second counting member comprises a plurality of gear teeth on an outer circumferential surface or an outer circumferential side surface, each of the gear teeth extending radially outward, and the second counting member being coaxially disposed with the first counting wheel, wherein a single tooth of the first counting wheel indirectly or directly engages one of the plurality of gear teeth of the second counting member once per rotation of the first counting wheel to intermittently rotate the second counting member, and The first counter wheel and the second counter member together display the number of doses remaining in the inhaler device or the number of doses delivered by the inhaler device.

38. The dry powder inhaler device of claim 37, wherein the actuator is a mouthpiece cover.

39. The dry powder inhaler device of claim 37, wherein the first count wheel rotates about a first axis and the second count member rotates about a second axis, the second axis being parallel to and spaced apart from the first axis.

40. The dry powder inhaler device of claim 37, wherein the first count wheel is an annular member.

41. The dry powder inhaler device of claim 37, wherein the marking display surface of the first count wheel includes a "ones" digit disposed thereon, and the marking display surface of the second count component includes a "tens" digit disposed thereon.

42. A dry powder inhaler device according to claim 41, wherein the marking display surface of the first count wheel and the marking display surface of the second count member are not located in the same plane, and the marking display surface of the second count member is closer to the display window of the inhaler device than the marking display surface of the first count wheel.

43. The dry powder inhaler device of claim 37, wherein the second counting component includes a single mark in place of the number zero, the single mark being a colored block without a number thereon.

44. The dry powder inhaler device of claim 37, wherein the second counter component comprises a dual marking, the dual marking being a colored block without numbers thereon, and wherein the dual marking is configured to cover the units digit of the first count wheel when no doses remain in the inhaler device.

45. The dry powder inhaler device of claim 37, wherein When the single tooth is not engaged with one of the plurality of gear teeth of the second counting member, the second counting member is in a stationary state.

46. ​​The dry powder inhaler device of claim 37, wherein a single tooth of the first count wheel directly engages a plurality of gear teeth of the second count member, and wherein the first count wheel and the second count member are configured to rotate in the same direction.

47. The dry powder inhaler device of claim 37, further comprising: an intermediate gear disposed between the inner circumferential surface or inner circumferential side surface of the first counting wheel and the outer circumferential surface or outer circumferential side surface of the second counting component, The single tooth of the first count wheel directly engages the intermediate gear, and the intermediate gear directly engages the plurality of gear teeth of the second count component, and wherein the first count wheel and the second count component are configured to rotate in opposite directions.

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