Dose counter subassembly for use in a dry powder inhaler - Patent Application 20070122997

Abstract

An inhalation device for delivering dry powder medicament from at least one blister strip. The inhalation device includes an actuator for operating a dispensing mechanism of the inhalation device. A dose counter subassembly for use in the inhalation device includes a first count wheel and a second counting component. The first count wheel and the second counting component together indicate the number of doses remaining in the inhalation device or the number of doses delivered by the inhalation device. The first count wheel is configured to be rotated by the dispensing mechanism, and the second counting component is driven by the first count wheel. The second counting component intermittently rotates or translates once for each rotation of the first count wheel.

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of U.S. Provisional Patent Application No. 63 / 483,393, filed February 6, 2023, the entire contents of which are incorporated herein by reference for all purposes.

[0002]

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

[0003] Medication can be administered to a patient by inhalation using a dry powder inhaler device. Such devices are often used for the treatment and prevention of respiratory diseases, including, but not limited to, asthma and chronic obstructive pulmonary disease (COPD). Dry powder inhaler devices may include a blister strip containing several individual doses of powdered medication. Such devices typically include a mechanism, such as a puncturing means, for accessing the medication doses by opening one or more blister pockets. The powdered medication can then be accessed by the device and inhaled through the device by the user.

[0004]

[0004] Devices of this type are often used regularly by patients and can form an important part of the patient's treatment. It is therefore beneficial for the patient to know how many doses remain in the device so that the patient can recognize when the device is empty and plan for device replacement. Furthermore, it is beneficial to ensure that the device is easy to operate, to increase the likelihood of correct use of the device and effective treatment. It is therefore preferable to minimize the number of operating steps and provide clear visual / tactile feedback. The present invention relates to a mechanism for advancing discrete drug doses in an inhalation device, and to a counter mechanism for indicating the number of doses remaining in the inhalation device. Summary of the Invention

[0005] According to a first embodiment of the present disclosure, the present disclosure provides a dry powder inhaler including: an actuator for operating a dispensing mechanism of the dry powder inhaler; a first count wheel configured to be rotated by the dispensing mechanism; and a second count component disposed adjacent to an outer periphery or portion of the first count wheel. The first count wheel includes a single tooth extending radially outward from the outer periphery or portion of the first count wheel. The second count component includes a plurality of notches on the outer surface or portion of the second count component, each notch extending radially inward and configured to mate with a single tooth. The single tooth of the first count wheel engages with one of the plurality of notches of the second count component once per rotation of the first count wheel to intermittently rotate the second count component, and the first count wheel and the second count component are configured to rotate in opposite directions. The first count wheel and the second counting component together indicate the number of doses remaining in the inhaler device or the number of doses delivered by the inhaler device.

[0006]

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

[0007]

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

[0008]

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

[0009]

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

[0010] In one aspect of the first embodiment, in combination with any other aspect herein, the present disclosure provides that the outer surface or outer portion of the second count component includes a plurality of segments, each segment extending between two adjacent notches of the plurality of notches, each segment being concave and forming an arcuate depression that mates with the outer circumferential surface or outer portion of the first count wheel.

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

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

[0013]

[0013] In one aspect of the first embodiment, in combination with any other aspect of the present specification, the present disclosure provides that the marking display surface of the first count wheel is provided with numbers in the "ones place" and the marking display surface of the second count component is provided with numbers in the "tens place".

[0014]

[0014] In one aspect of the first embodiment, in combination with any other aspect of the present specification, the present disclosure provides that the marking display surface of the first count wheel and the marking display surface of the second count component are coplanar.

[0015]

[0015] In one aspect of the first embodiment, in combination with any other aspect of the present specification, the present disclosure provides that the marking display surface of the first count wheel and the marking display surface of the second count component are not coplanar, and the marking display surface of the second count component is disposed closer to the display window of the inhalation device than the marking display surface of the first count wheel.

[0016]

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

[0017]

[0017] In one aspect of the first embodiment, in combination with any other aspect of the present specification, the present disclosure provides that the second count component includes a single flag instead of a zero, and the single flag is a colored block with no numbers on the single flag.

[0018] In one aspect of the first embodiment, in combination with any other aspect herein, the present disclosure provides that the second counting component includes a double flag, the double flag being a colored block with no numbers thereon, the double flag configured to cover the numbers on the first counting wheel when no doses remain in the inhalation device.

[0019]

[0019] In one aspect of the first embodiment, in combination with any other aspect herein, the present disclosure provides that the outer circumferential surface or outer portion of the first count wheel is generally circular with a clearance gap around a single tooth.

[0020]

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

[0021] In one aspect of the first embodiment, in combination with any other aspect herein, the present disclosure provides that the first count wheel includes a detent wheel having a plurality of notches. The dry powder inhaler further includes a housing and a flexible arm extending from the housing, the flexible arm including a detent thereon, the detent configured to be received within a notch of the plurality of notches of the first count wheel.

[0022]

[0022] In one aspect of the first embodiment, in combination with any other aspect of the present specification, the present disclosure provides that the flexible arm is configured to drive and fix the first count wheel within the target position.

[0023]

[0023] In one aspect of the first embodiment, in combination with any other aspect of the present specification, the present disclosure provides that the dry powder inhaler device further includes a housing and a flexible arm extending from the housing, the flexible arm including a detent on the flexible arm, the detent configured to be received within a notch of a plurality of notches in the second counting component.

[0024] According to a second embodiment of the present disclosure, the present disclosure provides a dry powder inhaler including an actuator for operating a dispensing mechanism of the dry powder inhaler, 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 side of the first count wheel. The second count component includes a plurality of rack teeth on an outer surface or portion of the second count component, the plurality of rack teeth being aligned longitudinally and extending outward toward the single tooth of the first count wheel. The single tooth of the first count wheel engages one of the rack teeth of the second count component once per complete rotation of the first count wheel to intermittently translate the second count component. The first count wheel and the second count component together indicate the number of doses remaining in the inhaler or the number of doses delivered by the inhaler.

[0025]

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

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

[0027]

[0027] In one aspect of the second embodiment, in combination with any other aspect of the present specification, the present disclosure provides that the first count wheel rotates about a first axis of the first count wheel and the second count component translates axially along an axis extending longitudinally of the inhalation device.

[0028]

[0028] In one aspect of the second embodiment, in combination with any other aspect of the present specification, the present disclosure provides that the longitudinally extending axis of the inhalation device is laterally spaced from the first axis.

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

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

[0031]

[0031] In one aspect of the second embodiment, in combination with any other aspect herein, the present disclosure provides that the marking display surface of the first count wheel is provided with numbers in the "ones" digit position, and the marking display surface of the second count component is provided with numbers in the "tens" digit position.

[0032]

[0032] In one aspect of the second embodiment, in combination with any other aspect of the present specification, the present disclosure provides that the marking display surface of the first count wheel and the marking display surface of the second count component are not coplanar, and the marking display surface of the second count component is disposed closer to the display window of the inhalation device than the marking display surface of the first count wheel.

[0033]

[0033] In one aspect of the second embodiment, in combination with any other aspect of the present specification, the present disclosure provides that the second count component includes a single flag instead of a zero number, and the single flag is a colored block with no number on the single flag.

[0034] In one aspect of the second embodiment, in combination with any other aspect herein, the present disclosure provides that the second counting component includes a double flag, the double flag being a colored block with no numbers thereon, the double flag configured to cover the units digit of the first counting wheel when no doses remain in the inhalation device.

[0035]

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

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

[0037] In one aspect of the second embodiment, in combination with any other aspect herein, the present disclosure provides that the first count wheel and the second counting component are disposed within a housing of a dry powder inhaler, the housing including a flexible arm extending from an interior surface of the housing, the flexible arm including a detent thereon, the detent configured to be received within a notch of a plurality of notches in the second counting component.

[0038]

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

[0039]

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

[0040]

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

[0041] According to a third embodiment of the present disclosure, the present disclosure provides a dry powder inhaler including an actuator for operating a dispensing mechanism of the dry powder inhaler, a first count wheel configured to be rotated by the dispensing mechanism, and a second count component at least partially disposed within the first count wheel. The first count wheel includes a single tooth extending radially inward from an inner periphery or portion of the first count wheel. The second count component includes a plurality of gear teeth on an outer periphery or portion, each gear tooth extending radially outward, and the second count component is non-concentric with the first count wheel. The single tooth of the first count wheel indirectly or directly engages one of the plurality of gear teeth of the second count component once per rotation of the first count wheel, thereby intermittently rotating the second count component. The first count wheel and the second count component together indicate the number of doses remaining in the inhaler or the number of doses delivered by the inhaler.

[0042]

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

[0043]

[0043] In one aspect of the third embodiment, 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 component 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, in combination with any other aspect herein, the present disclosure provides that the first count wheel is an annular component.

[0045]

[0045] In one aspect of the third embodiment, in combination with any other aspect herein, the present disclosure provides that the marking display surface of the first count wheel is provided with numbers in the "ones" digit position, and the marking display surface of the second count component is provided with numbers in the "tens" digit position.

[0046]

[0046] In one aspect of the third embodiment, in combination with any other aspect of the present specification, the present disclosure provides that the marking display surface of the first count wheel and the marking display surface of the second count component are not coplanar, and the marking display surface of the second count component is disposed closer to the display window of the inhalation device than the marking display surface of the first count wheel.

[0047]

[0047] In one aspect of the third embodiment, in combination with any other aspect of the present specification, the present disclosure provides that the second count component includes a single flag instead of a zero number, and the single flag is a colored block with no number on the single flag.

[0048] In one aspect of the third embodiment, in combination with any other aspect herein, the present disclosure provides that the second counting component includes a double flag, the double flag being a colored block with no numbers thereon, the double flag configured to cover the units digit of the first counting wheel when no doses remain in the inhalation device.

[0049]

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

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

[0051] In one aspect of the third embodiment, in combination with any other aspect herein, the present disclosure provides that the dry powder inhaler further includes an intermediate gear disposed between an inner circumferential surface or portion of the first count wheel and an outer circumferential surface or portion of the second count component. A single tooth of the first count wheel directly engages the intermediate gear, and the intermediate gear directly engages multiple gear teeth of the second count component. The first count wheel and the second count component are configured to rotate in opposite directions. [Brief explanation of the drawings]

[0052] [Figure 1A] 1 is a front view of an inhalation device according to an embodiment of the present invention, with the mouthpiece cover of the inhalation device in a closed position. [Figure 1B] 1B is a rear view of the inhalation device of FIG. 1A, with the mouthpiece cover of the inhalation device in a closed position. [Figure 1C]1B is a front view of the inhalation device of FIG. 1A, with the mouthpiece cover of the inhalation device in an open position. [Figure 1D] 1A-1C are graphs illustrating estimated actuation force profiles (dotted lines) for an inhalation device and mouthpiece cover as depicted in FIGS. 1A-1C compared with estimated actuation force profiles (solid lines) for an inhalation device in which the dispensing mechanism is not actuated during the initial period of movement of the mouthpiece cover. [Figure 2] FIG. 1B is a perspective view of two blister strips for use in the inhalation device of FIG. 1A. [Figure 3A] 1B is a front view of the inhaler device of FIG. 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. [Figure 3B] 1B is a cross-sectional perspective view of a portion of the inhalation device of FIG. 1A illustrating a portion of the airflow path through the inhalation device of FIG. 1A. [Figure 4] 1B is a perspective view of the manifold of the inhalation device of FIG. 1A, with the manifold removed from the inhalation device for illustrative purposes only. [Figure 4A] FIG. 5 is a cross-sectional view taken along line AA in FIG. [Figure 5] 1B is a perspective view of the manifold of FIG. 4 positioned adjacent to the inlet vent of the housing of the inhalation device of FIG. 1A. [Figure 6] 1B is another perspective view of the manifold of the inhalation device of FIG. 1A, with the manifold removed from the inhalation device for illustrative purposes only. [Figure 7] FIG. 7 is a schematic diagram illustrating the airflow path through the manifold of FIG. 6. [Figure 8] 7 is a schematic flow chart illustrating the airflow path through the manifold of FIG. 6. [Figure 9A] 1B is a front view of the inhaler device of FIG. 1A, with the mouthpiece cover of the inhaler device in an open position and a portion of the housing of the inhaler device removed for illustrative purposes only. [Figure 9B] 1B is a rear view of the inhalation device of FIG. 1A, with the mouthpiece cover and housing of the inhalation device removed for illustrative purposes only. [Figure 10] FIG. 1B is a front view of the ratchet mechanism of the inhaler device of FIG. 1A, with the ratchet gear removed from the inhaler device for illustrative purposes only. [Figure 10A] 11 illustrates the ratchet mechanism of FIG. 10 when the mouthpiece cover is in a closed position. [Figure 10B] 11 illustrates the ratchet mechanism of FIG. 10 when the mouthpiece cover is in the open position. [Figure 11] 1B is a perspective view of a portion of the mouthpiece cover and dispensing subassembly of the inhalation device of FIG. 1A, with the mouthpiece cover and dispensing subassembly removed from the inhalation device for illustrative purposes only. [Figure 12A] 1B is a schematic diagram of the tensioning mechanism of the inhalation device of FIG. 1A, the tensioning mechanism shown at the beginning of the device's life. [Figure 12B] 1B is a schematic diagram of the tensioning mechanism of the inhalation device of FIG. 1A, the tensioning mechanism shown near the end of the device's life. [Figure 13A] 1B is a perspective view of the tensioning mechanism of the inhalation device of FIG. 1A, with the tensioning mechanism removed from the inhalation device for illustrative purposes only. [Figure 13B] FIG. 13B is a cross-sectional view of the tensioning mechanism of FIG. 13A. [Figure 13C] FIG. 13B is a cross-sectional view of the tensioning mechanism of FIG. 13A. [Figure 13D] FIG. 13B is a perspective exploded view of the base and nut of the tensioning mechanism of FIG. 13A. [Figure 13E] 13B is a series of cross-sectional views of the tensioning mechanism of FIG. 13A illustrating the movement of the nut during operation of the inhalation device. [Figure 14A] 14B is a perspective view of the counter sub-assembly of the inhalation device of FIG. 14A, with the counter sub-assembly removed from the inhalation device for illustrative purposes only. [Figure 14B] FIG. 14B is a front view of the counter subassembly of FIG. 14A. [Figure 14C] 14B is a cross-sectional front view of the counter subassembly of FIG. 14A taken along line CC of FIG. 14B. [Figure 14D]14C is a cross-sectional front view of the counter subassembly of FIG. 14A taken along line DD of FIG. 14C. [Figure 15A] 1B is a perspective view of a counter sub-assembly according to another embodiment, the counter sub-assembly configured for use with the inhalation device of FIG. 1A, displaying 21 doses remaining. [Figure 15B] FIG. 15B is another perspective view of the counter sub-assembly of FIG. 15A, the counter sub-assembly displaying 0 doses remaining. [Figure 16A] 1B is a front view of a counter subassembly according to another embodiment, the counter subassembly configured for use with the inhalation device of FIG. 1A and displaying 26 doses remaining. [Figure 16B] 16B is a front cross-sectional view of the counter subassembly of FIG. 16A taken along line BB of FIG. 16A. [Figure 17] 1B is a front view of a counter subassembly according to another embodiment, the counter subassembly configured for use with the inhalation device of FIG. 1A and displaying 26 doses remaining. [Figure 18A] 1B is a front view of a counter subassembly according to another embodiment, the counter subassembly configured for use with the inhalation device of FIG. 1A, displaying 27 doses remaining. [Figure 18B] 18B is a front cross-sectional view of the counter subassembly of FIG. 18A taken along line BB of FIG. 18A. [Figure 19A] 1B is a front view of a counter subassembly according to another embodiment, the counter subassembly configured for use with the inhalation device of FIG. 1A and displaying 26 doses remaining. [Figure 19B] 19B is a cross-sectional front view of the counter subassembly of FIG. 19A taken along line BB of FIG. 19A. [Figure 20A] 1B is a front view of a counter sub-assembly according to another embodiment, the counter sub-assembly configured for use with the inhalation device of FIG. 1A and displaying 30 doses remaining. [Figure 20B] FIG. 20B is a front exploded view of the counter subassembly of FIG. 20A. [Figure 20C] 20B is a front view of the first count wheel, the second count wheel, and the transmission gear of the counter subassembly of FIG. 20A. FIG. [Figure 20D] FIG. 20B is a partial perspective view of the counter subassembly of FIG. 20A. [Figure 20E] 20B is a schematic cross-sectional view of a lens of the counter subassembly of FIG. 20A. [Figure 20F] 20B is a partial perspective view of the counter subassembly of FIG. 20A and the first bottom sheet winding gear used in the inhalation device of FIG. 1A. [Figure 20G] FIG. 20F is an enlarged perspective view of the first bottom sheet winding gear of FIG. 20F. [Figure 20H] FIG. 20F is an enlarged perspective bottom view of the transmission gear of FIG. 20F. [Figure 20I] 20B is a front elevational view of the counter subassembly of FIG. 20A. [Figure 20J] FIG. 20B is a front view of the backplate of the counter subassembly of FIG. 20A. [Figure 20K] FIG. 20B is a rear view of the first count wheel of the counter subassembly of FIG. 20A. [Figure 20L] 20J is a cross-sectional view of the first count wheel of the counter subassembly of FIG. 20A disposed within the backplate of FIG. 20J, with the first flexible arm in a first position. [Figure 20M] 20J is a cross-sectional view of the first count wheel of the counter subassembly of FIG. 20A disposed within the backplate of FIG. 20J, with the first flexible arm in a second position. DETAILED DESCRIPTION OF THE INVENTION

[0053]

[0105] Specific embodiments of the present invention will now be described with reference to the drawings, where like reference numbers indicate identical or functionally similar elements. The following detailed description is merely exemplary in nature and is not intended to limit the invention or the application and uses of the invention. Although the invention has been described in the context of a dry powder inhaler, the invention may be used in other applications where it is deemed useful. Furthermore, there is no intention to be bound by any expressed or implied theory presented in the preceding technical field, background, brief summary, or the following detailed description.

[0054]

[0106] Embodiments of the present invention relate to inhalation devices configured to deliver powdered medicament from at least one blister strip, and more particularly to a counter mechanism for indicating the number of doses remaining in the inhalation device. Although the counter mechanism described herein is shown in an inhalation device configured to simultaneously deliver powdered medicament from two blister strips, it may also be utilized in inhalation devices configured to deliver powdered medicament from a single blister strip or from three or more blister strips.

[0055]

[0107] 1A, 1B, and 1C illustrate an inhalation device 100 according to one embodiment of the present invention. The inhalation device 100 includes a housing 102 and a mouthpiece cover 108. The housing 102 includes a display window 104 that displays a number indicating the number of doses remaining in the inhalation device 100. The housing 102 also includes a plurality of openings or inlet vents 106 formed through a sidewall of the housing 102. As described in more detail herein, air from outside the inhalation device 100 is drawn into the interior of the inhalation device 100 through the inlet vents 106 when a user inhales through a mouthpiece 110. In FIGS. 1A and 1B, the mouthpiece cover 108 of the inhalation device 100 is in a closed position, with the mouthpiece cover 108 covering or extending over the mouthpiece 110. In FIG. 1C, the mouthpiece cover 108 is in an open position, such that the mouthpiece 110 is exposed and available to the user. A user can inhale powdered medicament through mouthpiece 110 only when mouthpiece cover 108 is in the open configuration. Mouthpiece 110 includes a central exit or opening 112 that allows delivery of powdered medicament contained within inhalation device 100 to a user via inhalation.

[0056]

[0108] 1A and 1B, the mouthpiece 110 and the inlet vent 106 are covered by the mouthpiece cover 108. When a user wishes to inhale a medication dose from the inhalation device 100, the mouthpiece cover 108 is moved from the closed position of FIGS. 1A and 1B to the open position of FIG. 1C. In the open position, the mouthpiece cover 108 is rotated or moved relative to the housing 102 so that the mouthpiece 110 and the inlet vent 106 are fully exposed and are no longer covered by any portion of the mouthpiece cover 108. Because the user is instructed to cover the central opening 112 of the mouthpiece 110 with their mouth during inhalation of a powdered medication, the mouthpiece cover 108 protects the mouthpiece 110 when the inhalation device 100 is not in use, preventing contamination of the airflow passageway of the inhalation device 100 with undesirable particles that could otherwise adversely affect the user experience and / or dose delivery. As described in more detail herein, movement of mouthpiece cover 108 from the closed position to the open position activates a dispensing mechanism within inhalation device 100 to make a medication dose available for inhalation, and also activates a counter mechanism within inhalation device 100 to decrement by one the number of remaining doses indicated in viewing window 104. Thus, mouthpiece cover 108 functions to protect central opening 112 of mouthpiece 110 and also operates the dispensing and counter mechanisms of inhalation device 100. A single operational step, namely, movement of mouthpiece cover 108, is all that is required by the user to activate inhalation device 100 for each dose.

[0057]

[0109] In one embodiment, the mouthpiece cover 108 may be rotated 85° to 105° by the user to expose the mouthpiece 110 and inlet vent 106. When designing the inhalation device 100, it is important to ensure that the force required to actuate the mouthpiece cover 108 is low enough to allow easy operation by users of various abilities. Generally, the longer the travel distance of the mouthpiece cover 108, the more favorable mechanical advantage is achieved in the inhalation device's dispensing mechanism, resulting in a lower actuation force required to rotate the mouthpiece cover 108 and actuate the inhalation device 100 for each dose. However, from an ergonomic standpoint, a shorter travel distance of the mouthpiece cover 108 avoids the need for the user to change grip during actuation. The shorter the travel distance of the mouthpiece cover 108, the smaller the area of ​​the housing 102 traversed by the mouthpiece cover 108, and therefore the greater the area of ​​the housing 102 for the user to grip during actuation. A shorter travel for the mouthpiece cover 108 also allows more space for other features of the inhalation device 100 and / or allows the size of the inhalation device 100 to be minimized. In one embodiment, a cover travel of 90-100 degrees may provide an optimal balance between the factors discussed above. As shown in Figures 1A-1C, the housing 102 has an integral flange or step 102A formed thereon that controls or limits the rotational movement of the mouthpiece cover 108 to a desired range.

[0058]

[0110] The force profile over the movement of the mouthpiece cover 108 affects the user experience and tactile feedback provided by the inhalation device 100. Maintaining a relatively consistent or constant actuation force over the movement of the mouthpiece cover 108 is also preferable to avoid incorrect use or confusion. Using the full movement of the mouthpiece cover 108 to operate the dispensing mechanism is expected to provide a more consistent actuation force profile and help reduce the risk of misuse of the inhalation device 100. For example, in inhalation devices other than the present invention, in which the dispensing mechanism is not activated during the initial period of mouthpiece cover movement, the actuation force is relatively low during this initial period. Once the dispensing mechanism is activated, the actuation force of the mouthpiece cover increases. Thus, in inhalers other than the present invention, the actuation force of the mouthpiece cover increases significantly midway through the full movement of the mouthpiece cover, and a user may mistakenly perceive this change as tactile feedback suggesting that the mouthpiece cover is sufficiently open to take a dose. In other words, a non-constant actuation force profile may confuse a user regarding tactile feedback, potentially leading to incorrect use of the device. 1D illustrates an estimated actuation force profile, represented by the dashed line, for an inhalation device 100 according to embodiments herein having a mouthpiece cover 108, compared to an estimated actuation force profile, represented by the solid line, for an inhalation device in which the dispensing mechanism is not activated for the initial period of mouthpiece cover movement, as described in the previous example. When the dispensing mechanism is not activated at the beginning of mouthpiece movement, there is a step in the actuation force profile, represented by the solid line in FIG. 1D. Conversely, when the dispensing mechanism is activated at the beginning of mouthpiece movement, as in inhalation device 100, the actuation force is approximately constant or consistent, with a lower peak actuation force, as represented by the dashed line in FIG. 1D.

[0059]

[0111] The inhalation device 100 is configured to simultaneously dispense dry powder medicament from two blister strips. More specifically, referring to FIG. 2 , a first blister strip 160A and a second blister strip 160B are shown. The inhalation device 100 described herein is configured to simultaneously dispense medicament from each of the first blister strip 160A and the second blister strip 160B. Each blister strip 160A, 160B includes a bottom sheet 162A, 162B, respectively, defining a series or plurality of individual blisters or pockets 164A, 164B thereon. Each pocket 164A, 164B is configured to contain a dose or portion of a dry powder or powdered medicament 168A, 168B to be inhaled by a user. In one embodiment, powdered medicament 168A is a different medicament from powdered medicament 168B, such that inhalation device 100 is configured to simultaneously deliver two different powdered medicaments to a user. Top sheets 166A, 166B are hermetically bonded or sealed to bottom sheets 162A, 162B, respectively, to close pockets 164A, 164B, and function as lids for pockets 164A, 164B to hold powdered medicaments 168A, 168B therein. The hermetic sealing of top sheets 166A, 166B is such that bottom sheets 162A, 162B and top sheets 166A, 166B can be peeled apart to open or uncover pockets 164A, 164B for access to powdered medicaments 168A, 168B therein. Each of first blister strip 160A and second blister strip 160B is sufficiently flexible to be wound into a roll.

[0060]

[0112] As described in more detail herein, when the dispensing mechanism of inhalation device 100 is actuated via movement of mouthpiece cover 108, top sheets 166A, 166B of blister strips 160A, 160B are peeled away from bottom sheets 162A, 162B of blister strips 160A, 160B, respectively, to release or open pockets 164A, 164B of each blister strip, thereby exposing powdered medicament 168A, 168B disposed therein. Upon inhaling through mouthpiece 110, the user simultaneously inhales powdered medicament 168A, 168B from the opened pockets 164A, 164B of blister strips 160A, 160B, respectively. Thus, the user receives a metered dose of medicament powder, with different medicament powders from the opened pockets 164A, 164B of blister strips 160A, 160B each constituting a respective dose portion. Each blister strip 160A, 160B may be the same size and / or contain the same dose (e.g., volume or mass) of powdered medicament, or may be different sizes and / or contain different doses of powdered medicament.

[0061]

[0113] 3A is a front view of inhalation device 100 with mouthpiece cover 108 in an open position and housing 102 removed for illustrative purposes only. Inhalation device 100 includes a manifold 114 for internally directing airflow to pick up powdered medicaments 168A, 168B from blister strips 160A, 160B, respectively, through mouthpiece 110 and deliver them to a user. Manifold 114 is in fluid communication with mouthpiece 110 such that powdered medicaments 168A, 168B may be delivered to a user through a central opening 112 of mouthpiece 110. In addition to manifold 114, inhalation device 100 also includes a dispensing subassembly or mechanism 120, a counter subassembly or mechanism 134, and tensioning subassemblies or mechanisms 151A, 151B. When assembled, manifold 114 , dispensing subassembly 120 , counter subassembly 134 , and each of tensioning mechanisms 151 A, 151 B reside or are disposed within housing 102 .

[0062]

[0114] The operation of the manifold 114 is introduced herein with reference to FIG. 3B. The manifold 114 defines an airway through the inhalation device 100. The manifold 114 fluidly connects the mouthpiece 110 to the first blister strip 160A and the second blister strip 160B. FIG. 3B is a cross-sectional view through the manifold to illustrate the airflow path through the manifold 114 for loading the medicament 168B of the second blister strip 160B. As will be described with respect to FIGS. 10-14, the manifold 114 also defines an airflow path therein for loading the medicament 168A of the first blister strip 160A.

[0063]

[0115] During use, the mouthpiece cover 108 is rotated by a user to expose the mouthpiece 110 and the inlet vent 106. Internally, within the inhalation device 100, rotating the mouthpiece cover 108 exposes the powdered medicaments 168A, 168B within the pockets 164A, 164B of each of the first blister strip 160A and second blister strip 160B, respectively. To access the powdered medicaments 168A, 168B within the open pockets 164A, 164B, the user breathes in or inhales through the mouthpiece 110. The user covers the central opening 112 of the mouthpiece 110 with their mouth and, by inhaling, creates a pressure differential between the inlet vent 106 and the central opening 112, moving air through the manifold 114. The pressure differential causes external air (i.e., air from outside the inhalation device 100) to enter the inhalation device 100 through the inlet vent 106, pass through the open pockets 164A, 164B, and exit the inhalation device 100 through the central opening 112. The airflow path defined by the manifold 114 is designed so that, as a user inhales, the exposed powdered medicament 168A, 168B in the open pockets 164A, 164B is picked up by the air stream and delivered to the user as a combined oral inhalation medicament dose. Thus, the user can inhale one dose portion from each blister strip 160A, 160B simultaneously.

[0064]

[0116] Manifold 114 is configured to preferentially direct the inhalation airflow in various ways to achieve airflow characteristics suitable for effective delivery of the powdered medicament. More specifically, as shown in FIG. 3B, the geometry of manifold 114 directs a portion of the inhalation airflow into and out of open pocket 164B of second blister strip 160B (labeled by dotted line 199 in FIG. 3B), while another portion of the inhalation airflow travels through a diverting section or hole in manifold 114 (described in more detail in FIGS. 4-8). The portion of the inhalation airflow through open pocket 164B entrains a dose of powdered medicament 168B into the airflow, and the portion of the inhalation airflow through a diverting section within manifold 114 intersects with the entrained airflow portion, grinding up the powdered medicament therein before exiting manifold 114.

[0065]

[0117] 4-8, manifold 114 will be described in more detail. Manifold 114 is configured to simultaneously deliver powdered medicaments 168A, 168B from respective open blister pockets 164A, 164B of each of first blister strip 160A and second blister strip 160B, respectively. Manifold 114 includes a body 170 that defines a first space or atrium 172A, a second space or atrium 172B, and a stack 180. As described in more detail herein, the separate and distinct compartments or spaces of first atrium 172A, second atrium 172B, and stack 180 divide, split, or otherwise separate the inhalation airflow drawn into manifold 114 by a user into multiple airflow paths through body 170 of manifold 114. More specifically, when an inhalation force is applied through the central opening 112 of the mouthpiece 110, the inhalation airflow is drawn through the inlet vent 106 of the inhalation device 100 into the first atrium 172A and the second atrium 172B of the manifold 114. The first atrium 172A and the second atrium 172B are disposed adjacent to or in juxtaposed relationship with the inlet vent 106. Upon entering the manifold 114, the inhalation airflow divides or splits into four airflow paths as it travels through the main body 170 of the manifold: a first diverted airflow path 192, a second diverted airflow path 194, a first intake airflow path 196, and a second intake airflow path 198. In other words, each of the first diverted air flow path 192, the second diverted air flow path 194, the first intake air flow path 196, and the second intake air flow path 198 is a respective air flow portion of the intake air flow that is drawn into the manifold 114.

[0066]

[0118] In this embodiment, the first atrium 172A and the second atrium 172B are disposed laterally adjacent to or alongside one another on one side of the main body 170 of the manifold 114. The first atrium 172A and the second atrium 172B are separated from one another by a partition wall 173 such that the first atrium 172A is not in fluid communication with the second atrium 172B. The first atrium 172A includes a single atrium inlet 174A, and the second atrium 172B includes a single atrium inlet 174B. The atrium inlets 174A, 174B are separate from one another and can also be considered inlets to the manifold 114. Thus, the manifold 114 includes two inlets: the atrium inlet 174A leading to or into the first atrium 172A, and the atrium inlet 174B leading to or into the second atrium 172B.

[0067]

[0119] The first atrium 172A includes a first atrium outlet 176A and a second atrium outlet 178A, and the second atrium 172B includes a first atrium outlet 176B and a second atrium outlet 178B. As described in more detail herein, the first atrium outlets 176A, 176B of each of the first atrium 172A and the second atrium 172B, respectively, direct or guide flow directly into the stack 180, and the second atrium outlets 178A, 178B of each of the first atrium 172A and the second atrium 172B, respectively, direct or guide flow into the open pockets 164A, 164B of the first blister strip 160A and the second blister strip 160B, respectively. In one embodiment, the profile or shape of the first atrium outlets 176A, 176B is substantially rectangular or oblong. However, the profile or shape of the first atrium outlets 176A, 176B is not limited to the shapes depicted 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 atrium outlets 178A, 178B is substantially circular and includes a grille or crosspiece 197 (see FIG. 4) extending thereover to promote increased turbulence in the airflow. However, the profile or shape of the second atrium outlets 178A, 178B is not limited to the shapes depicted herein and may alternatively be rectangular, oblong, oval, triangular, or any other shape deemed suitable for the purposes described herein, with or without a grille extending thereover.

[0068]

[0120] 7, stack 180 is in fluid communication with each of first atrium 172A, second atrium 172B, open pocket 164A of first blister strip 160A, and second open pocket 164B of second blister strip 160B. Stack 180 has four inlets: first stack inlet 182, second stack inlet 184, third stack inlet 186, and fourth stack inlet 188. First stack inlet 182 is positioned with first atrium outlet 176A of first atrium 172A such that stack 180 and first atrium 172A are in fluid communication with each other. The second stack inlet 184 is aligned with the open pocket 164A of the first blister strip 160A such that the second stack inlet 184 is further in fluid communication with the second atrium outlet 178A of the first atrium 172A via the open pocket 164A. The third stack inlet 186 is in fluid communication with the second atrium outlet 176B of the second atrium 172B such that the stack 180 and the second atrium 172B are in fluid communication with each other. The fourth stack inlet 188 is in fluid communication with the open pocket 164B of the second blister strip 160B such that the fourth stack inlet 188 is further in fluid communication with the second atrium outlet 178B of the second atrium 172B via the open pocket 164B.

[0069]

[0121] The profile or shape of each of the first stack inlet 182 and the third stack inlet 186 is substantially rectangular or oblong. However, the profile or shape of the first stack inlet 182 and the third stack inlet 186 is not limited to the shape depicted 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 stack inlet 184 and the fourth stack inlet 188 is substantially circular and includes a grille or crosspiece 195 (see FIG. 4 ) extending thereover to promote increased turbulence in the airflow. However, the profile or shape of the second stack inlet 184 and the fourth stack inlet 188 is not limited to the shape depicted herein and may alternatively be rectangular, oblong, oval, triangular, or any other shape deemed suitable for the purposes described herein, with or without a grille extending thereover.

[0070]

[0122] The stack 180 is a single stack having a single stack outlet 190. Thus, in this embodiment, the stack 180 has only one stack outlet 190. The stack outlet 190 can also be considered an outlet of the manifold 114. Thus, the manifold 114 includes only one outlet. The shape or profile of the stack outlet 190 is elliptical. However, the profile or shape of the stack outlet 190 is not limited to the shapes depicted herein and may alternatively be circular, rectangular, oblong, triangular, or any other shape deemed suitable for the purposes described herein. When the manifold 114 is assembled to the inhalation device 100, the stack outlet 190 is positioned and in fluid communication with the central opening 112 of the mouthpiece 110.

[0071]

[0123] The second atrium outlet 178A of the first atrium 172A is in fluid communication with the second stack inlet 184 to define a first intake airflow path 196 associated with the open blister pocket 164A of the first blister strip 160A. As the air stream flows through the open blister pocket 164A, it picks up the powdered medicament 168A disposed within the open blister pocket 164A. Thus, by passing through the open blister pocket 164A, the powdered medicament 168A is drawn into and transported by the air stream into the stack 180. After intake, the air stream contains the powdered medicament 168A.

[0072]

[0124] Similarly, the second atrium outlet 178B of the second atrium 172B is in fluid communication with the fourth stack inlet 188 to define a second intake airflow path 198 associated with the open blister pocket 164B of the second blister strip 160B. As the air stream flows through the open blister pocket 164B, it picks up the powdered medicament 168B disposed therein. Thus, by passing through the open blister pocket 164B, the powdered medicament 168B is drawn into and transported by the air stream into the stack 180. After intake, the air stream contains the powdered medicament 168B.

[0073]

[0125] The first atrium outlet 176A of the first atrium 172A is in fluid communication with the first stack inlet 182 to define a first diverted airflow path 192 of the manifold 114. Similarly, the first atrium outlet 176B of the second atrium 172B is in fluid communication with the third stack inlet 186 to define a second diverted airflow path 194 of the manifold 114. Each of the diverted airflow paths 192, 194 provides a lower resistance path for air flowing from outside the inhalation device 100 to the patient's mouth compared to the first and second intake airflow paths 196, 198. As a result, the overall airflow resistance of the inhalation device 100 is reduced, thereby enabling a higher overall flow rate to be achieved for the same inhalation pressure. Additionally, the diverted airflow paths 192, 194 provide for deagglomeration of the powdered medicaments 168A, 168B before they exit the manifold 114. Each of the first and second diverted airflow paths 192, 194 is configured to disrupt each of the first and second intake airflow paths 196, 198, thereby breaking down the medicament carried therethrough. More specifically, the first diverted airflow path 192 is directed into the path of the first intake airflow path 196 at a different angle from the first diverted airflow path 192. A region of higher shear is formed at the intersection between the first diverted airflow path 192 and the first intake airflow path 196, improving deagglomeration of the powdered medicament 168A before it exits the manifold 114. Similarly, the second diverted airflow path 194 is directed into the path of the second intake airflow path 198 at a different angle from the second diverted airflow path 194. A region of higher shear is formed at the intersection between the second diverted air flow path 194 and the second intake air flow path 198, improving deagglomeration of the powdered medicament 168B before it exits the manifold 114. The first diverted air flow path 192, the second diverted air flow path 194, the first intake air flow path 196, and the second intake air flow path 198 combine or mix within the stack 180 before exiting the manifold 114.

[0074]

[0126] 8, the inhalation air stream drawn in from outside the inhalation device 100 is split between two inlets of the manifold 114, namely, the first atrium inlet 174A and the second atrium inlet 174B. Thus, the inhalation air stream drawn in from outside the inhalation device simultaneously enters each of the first atrium 172A and the second atrium 172B. A first portion of the inhalation air stream entering the first atrium 172A flows into the open blister pocket 164A, and a second portion of the inhalation air stream entering the first atrium 172A flows directly into the stack 180. The first portion of the inhalation air stream in the open blister pocket 164A picks up or entrains the powdered medicament 168A disposed in the open blister pocket 164A and then continues into the stack 180. Within the stack 180, the second portion of the inhalation air stream from the first atrium 172A breaks up or deagglomerates the powdered medicament 168A entrained within the first portion of the inhalation air stream. Similarly, simultaneously, the first portion of the inhalation air stream entering the second atrium 172B flows into the open blister pocket 164B, and the second portion of the inhalation air stream entering the second atrium 172B flows into the stack 180. The first portion of the inhalation air stream within the open blister pocket 164B picks up or entrains the powdered medicament 168B disposed within the open blister pocket 164B and then continues into the stack 180. Within the stack 180, the second portion of the inhalation air stream from the second atrium 170B breaks up or deagglomerates the powdered medicament 168B entrained within the first portion of the inhalation air stream. Within stack 180, all portions of the air stream mix together before exiting manifold 114 toward the patient's mouth, and the combined air stream contains both medicament 168A from first blister strip 160A and medicament 168B from second blister strip 160B. Air flow through first atrium 172A and open blister pocket 164A is simultaneous with air flow through second atrium 172B and open blister pocket 164B.

[0075]

[0127] Due to the fact that the first atrium 172A and the second atrium 172B are separate and distinct compartments with the partition wall 173 extending between them, the inhalation air stream entering the manifold 114 is preferentially directed towards the outlet of each atrium. By directing the separated inhalation air streams into the open blister pockets 164A, 164B in this manner, the turbulent energy of the airflow at this stage is reduced, and therefore the overall airflow resistance of the inhalation device 100. The overall airflow resistance can allow the patient to achieve a higher flow rate at the same inhalation pressure, thereby improving the effectiveness of drug delivery.

[0076]

[0128] 9A and 9B, the dispensing subassembly 120 of the inhalation device 100 will be described in more detail. The dispensing subassembly 120 is configured to advance each blister strip 160A, 160B and open its pockets 164A, 164B each time the mouthpiece cover 108 is fully opened by the user. 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 via an internal chassis 116 disposed within the housing 102. Via the dispensing subassembly 120, the consecutive pockets 164A, 164B of each blister strip 160A, 160B are guided toward a manifold 114 disposed along or approximately along the centerline of the inhalation device 100. When placed in manifold 114, pockets 164A, 164B of each blister strip 160A, 160B are open, and powdered medicament 168A, 168B in the open pockets of each blister strip 160A, 160B are available for inhalation. As described herein, the empty bottom sheets 162A, 162B and top sheets 166A, 166B of blister strips 160A, 160B are rolled up by dispensing subassembly 120. FIG. 9A is a front view of inhalation device 100 with mouthpiece cover 108 in the open position, with the front half or portion of housing 102 of inhalation device 100 removed for illustrative purposes only. FIG. 9B is a rear view of inhalation device 100 with mouthpiece cover 108 and housing 102 removed for illustrative purposes only.

[0077]

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

[0078]

[0130] As shown in FIG. 11 , first indexing gear 130A and second indexing gear 130B are attached to or integrally formed with first indexing spool 131A and second indexing spool 131B, respectively. First indexing spool 131A and second indexing spool 131B each include a pair of recesses 132A and 132B thereon, respectively. Each recess of the pair of recesses 132A and 132B is configured to receive a pocket 164A and 164B of blister strip 160A and 160B, respectively. Through rotation of first indexing gear 130A and second indexing gear 130B, first indexing spool 131A and second indexing spool 131B rotate and operate to move recesses 132A and 132B, respectively, adjacent to or juxtaposed with manifold 114. As blister strips 160A, 160B are advanced by indexing spools 131A, 131B, top sheets 166A, 166B of blister strips 160A, 160B are peeled away from bottom sheets 162A, 162B of the blister strips such that their pockets 164A, 164B adjacent manifold 114 are opened and the powdered medicament 168A, 168B therein are available for ingestion. More specifically, top sheets 166A, 166B are peeled away from bottom sheets 162A, 162B, respectively, such that pockets 164A, 164B of each bottom sheet 162A, 162B are opened or opened to expose respective doses of powdered medicament 168A, 168B. Opening or unrolling pockets 164A, 164B is accomplished by relative rotation between indexing spools 131A, 131B and upper sheet take-up gears 150A, 150B. Indexing spools 131A, 131B essentially grip bottom sheets 162A, 162B, respectively, and upper sheet take-up gears 150A, 150B essentially grip top sheets 166A, 166B, respectively. As indexing spools 131A, 131B and upper sheet take-up gears 150A, 150B rotate relative to one another, bottom sheets 162A, 162B and top sheets 166A, 166B are peeled away from one another.As described in more detail herein, indexing spools 131A, 131B and top sheet take-up gears 150A, 150B are driven to rotate in opposite directions via gearing such that each top sheet 166A, 166B is peeled from its respective bottom sheet 162A, 162B as the gears are driven. Thus, dispensing subassembly 120 opens and places each leading pocket 164A, 164B in fluid communication with manifold 114, thereby making the powdered medicament 168A, 168B in the opened pocket 164A, 164B available for inhalation.

[0079]

[0131] The first and second bottom sheet take-up gears 128A and 128B operate to take up the empty bottom sheets 162A and 162B of the blister strips 160A and 160B, respectively. As shown in FIG. 11 , the first and second bottom sheet take-up gears 128A and 128B are attached to or integrally formed with spindles 129A and 129B, respectively. Through rotation of the first and second bottom sheet take-up gears 128A and 128B, the first and second spindles 129A and 129B rotate and operate to take up the bottom sheets 162A and 162B as the inhalation device 100 operates. The ends of each bottom sheet 162A, 162B are fixed to the first bottom sheet winding gear 128A and the second bottom sheet winding gear 128A so that progressive rotation of the first bottom sheet winding gear 128A and the second bottom sheet winding gear 128B causes the bottom sheets 162A, 162B to be wound around them into tight coils.

[0080]

[0132] The first upper sheet take-up gear 150A and the second upper sheet take-up gear 150B operate to wind the upper sheets 166A and 166B of the blister strips 160A and 160B, respectively. As described in more detail herein with respect to Figures 14A-14E, the first upper sheet take-up gear 150A and the second upper sheet take-up gear 150B are coupled to wind-up hubs 152A and 152B, respectively. Through rotation of the first upper sheet take-up gear 150A and the second upper sheet take-up gear 150B, the first wind-up hub 152A and the second wind-up hub 152B rotate and operate to wind or wind the upper sheets 166A and 166B as the inhalation device 100 operates. The ends of each upper sheet 166A, 166B are fixed to the first and second winding hubs 152A, 152B so that the progressive rotation of the first and second upper sheet winding gears 150A, 150B causes the upper sheets 166A, 166B to be wound therearound into tight coils.

[0081]

[0133] The central driver gear 122 of the dispensing subassembly 120 is attached to the mouthpiece cover 108 via a ratchet mechanism 124. The ratchet mechanism 124 is shown removed from the inhalation device 100 in FIG. 10 . The ratchet mechanism 124 includes a ratchet 125 attached to the mouthpiece cover 108 and a ratchet gear 123 formed with or attached to the central driver gear 122. When the mouthpiece cover 108 is opened, the ratchet 125 is driven in a second, opposite direction by the mouthpiece cover 108. The ratchet 125 then drives the ratchet gear 123 in the second, opposite direction to advance or actuate the dispensing subassembly 120. When the mouthpiece cover 108 is returned to its closed position, the dispensing subassembly 120 does not advance or actuate and remains stationary. Therefore, the opening movement of the mouthpiece cover 108 is transmitted to the central driver gear 122 , but the closing movement of the mouthpiece cover 108 is not transmitted to the central driver gear 122 .

[0082]

[0134] More specifically, ratchet gear 123 includes a plurality of circumferentially spaced inner stop surfaces 123A and outer stop surfaces 123B around its outer periphery or edge. Ratchet 125 includes a plurality of flexible ratchet arms 125A configured to interact with the circumferentially spaced inner stop surfaces 123A of ratchet gear 123. Ratchet 125 rotates in a first direction with mouthpiece cover 108 as mouthpiece cover 108 moves from a closed first position to an open second position. When rotating in the first direction, ratchet arms 125A engage and drive the circumferentially spaced inner stop surfaces 123A of ratchet gear 123, as shown in FIG. 10B, so that torque is transmitted to central driver gear 122. Ratchet gear 123 is attached to or formed with central driver gear 122 so that central driver gear 122 rotates in a first direction simultaneously with mouthpiece cover 108. As described above, movement of mouthpiece cover 108 to the second position results in the opening and placement of pockets 164A, 164B of each blister strip 160A, 160B for subsequent simultaneous inhalation of powdered medicament 168A, 168B by the patient.

[0083]

[0135] However, when mouthpiece cover 108 is returned to its closed first position, ratchet arms 125A do not interact with inner stop surfaces 123A of ratchet gear 123, and therefore, reverse rotation of ratchet 125 is not transmitted to central driver gear 122. More specifically, when ratchet 125 is rotated in a second, opposite direction (i.e., counterclockwise), ratchet arms 125A flex radially inward and no significant torque is transmitted to ratchet gear 123 and central driver gear 122. Frictional drag between the ratchet 125 and the ratchet gear 123 may tend to temporarily pull the ratchet gear 123 in a second, opposite direction (i.e., counterclockwise), but as shown in FIG. 10A, reverse winding is prevented by interaction between one of the outer stop surfaces 123B of the ratchet gear 123 and the flexible arm 121 in the retainer plate of the inhalation device 100.

[0084]

[0136] In one embodiment, a detent (not shown) can be disposed between the inner surface of the mouthpiece cover 108 and the outer surface of the housing 102. The detent can be a mating protrusion and groove configured to temporarily resist or prevent movement of the mouthpiece cover 108 relative to the housing 102 until a user applies a force to the mouthpiece cover 108 (i.e., when opening the mouthpiece cover 108) and releases the detent by moving one of the mating features of the detent out of or past the other of the mating features of the detent. For example, a protrusion, bump, or other raised structure can be formed on the outer surface of the housing 102, and a mating groove, dimple, or other recessed structure can be formed on the inner surface of the mouthpiece cover 108. Alternatively, a protrusion, bump, or other raised structure can be formed on the inner surface of the mouthpiece cover 108, and a mating groove, dimple, or other recessed structure can be formed on the outer surface of the housing 102. The groove is configured to receive the recess when the mouthpiece cover 108 is in the closed position of FIG. 1A. When a user applies sufficient force to overcome the friction between the mating projections and grooves, the mouthpiece cover 108 begins to open, moving away from the closed position of Figure 1A. The detents are configured to prevent or inhibit unintentional opening of the mouthpiece cover 108. Additionally, the detents are configured to account for rotational clearances or tolerances within the ratchet mechanism 124 so that the dispensing and counter mechanisms within the inhalation device 100 are actuated upon initial or initial movement of the mouthpiece cover 108 from the closed position toward the open position.

[0085]

[0137] 11 , central driver gear 122 directly or indirectly drives the remaining gears of dispensing subassembly 120. This gear train configuration provides incremental indexing or advancement of blister strips 160A, 160B via first indexing gear 130A and second indexing gear 130B, and also provides winding (via top sheet take-up gears 150A, 150B and bottom sheet take-up gears 128A, 128B, respectively) of the top and bottom sheets of blister strips 160A, 160B due to rotational movement of mouthpiece cover 108 in a first direction from its closed, first position to its open, second position. As central driver gear 122 rotates with mouthpiece cover 108 in a first direction, central driver gear 122 engages or directly drives second indexing gear 130B to rotate it in a second, opposite direction. Therefore, the second spool 131B, and the second blister strip 160B advanced thereby, also rotate in the second, opposite direction. As the second indexing gear 130B rotates in the second, opposite direction, the second indexing gear 130B engages with or directly drives the first indexing gear 130A, causing it to rotate in the first direction. Therefore, the first spool 131A, and the first blister strip 160A advanced thereby, also rotate in the first direction.

[0086]

[0138] In one embodiment, the first direction is clockwise and the second, opposite direction is counterclockwise. In the depicted embodiment, when mouthpiece cover 108 is opened, central driver gear 122 rotates in a clockwise direction. Thus, second indexing gear 130B (together with second spool 131B and second blister strip 160B) rotates in a counterclockwise direction, and first indexing gear 130A (together with first spool 131A and first blister strip 160A) rotates in a clockwise direction. However, as will be understood by those skilled in the art, the first direction can alternatively be counterclockwise and the second, opposite direction can be clockwise, so long as the gear train formed by dispensing subassembly 120 moves or advances first blister strip 160A in the opposite direction to second blister strip 160B. Additionally, as will be understood by those skilled in the art, the gear train formed by dispensing subassembly 120 may include one or more idler gears (not shown) that change the order of rotation between central driver gear 122, second indexing gear 130B, and first indexing gear 130A. The presence of such idler gears does not affect the overall function of the gear train, as long as the gear train moves or advances first blister strip 160A in the opposite direction to second blister strip 160B. For example, an idler gear (not shown) may be disposed between central driver gear 122 and first indexing gear 130A, such that central driver gear 122 (rotating in a first direction) directly drives the idler gear to rotate in a second, opposite direction. The idler gear may be arranged to directly drive a first indexing gear 130A in a first direction, and the first indexing gear 130A directly drives a second indexing gear 130B in a second, opposite direction.

[0087]

[0139] To maintain tension applied to blister strips 160A, 160B, first bottom sheet take-up gear 128A and second bottom sheet take-up gear 128B rotate simultaneously in the same direction with first indexing gear 130A and second indexing gear 130B, respectively, and first top sheet take-up gear 150A and second top sheet take-up gear 150B rotate simultaneously in the opposite direction with first indexing gear 130A and second indexing gear 130B, respectively. As central driver gear 122 rotates in a first direction, central driver gear 122 engages with or directly drives first idler gear 126 to rotate it in a second, opposite direction, and first idler gear 126 engages with or directly drives first bottom sheet take-up gear 128A to rotate it in the first direction. Thus, first spindle 129A, and thus bottom sheet 162A wound thereby, also rotates in a first direction to wind or take up empty bottom sheet 162A of first blister strip 160A as first blister strip 160A is advanced by dispensing subassembly 120. In addition, first top sheet take-up gear 150A interacts with or is driven by first indexing gear 130A. As first indexing gear 130A rotates in the first direction, first top sheet take-up gear 150A is driven to rotate in a second, opposite direction to wind up top sheet 166A of first blister strip 160A.

[0088]

[0140] As central driver gear 122 rotates in a first direction, first idler gear 126 is driven to rotate in a second, opposite direction as described above, and first idler gear 126 mates with or directly drives second idler gear 127, causing it to rotate in the first direction. Second idler gear 127 mates with or directly drives second bottom sheet take-up gear 128B, causing it to rotate in the second direction. Thus, second spindle 129B, and the bottom sheet 162B wound thereby, also rotates in the second direction, causing or taking up the empty bottom sheet 162B of second blister strip 160B as second blister strip 160B is advanced by dispensing subassembly 120. Additionally, the second upper sheet take-up gear 150B interacts with or is driven by the second indexing gear 130B. As the second indexing gear 130B rotates in the second opposite direction, the second upper sheet take-up gear 150B is driven to rotate in the first direction to wind up the upper sheet 166B of the second blister strip 160B.

[0089]

[0141] 12A, 12B, and 13A-13E, first tensioning mechanism 151A and second tensioning mechanism 151B are described in more detail. Tensioning mechanisms 151A and 151B function to peel top sheets 166A and 166B from first blister strip 160A and second blister strip 160B, respectively, to maintain a consistent peel distance or volume over the life of the device. More specifically, tensioning mechanisms 151A and 151B ensure that the peel distance of top sheets 166A and 166B is configured to adequately open pockets 164A and 164B for each dose to achieve effective dispensing of powdered medicament 168A and 168B to the user. If the peel distance or volume is too low, the pockets may not be fully exposed, making it more difficult to achieve sufficient expulsion of the powdered medicament disposed therein upon inhalation. Furthermore, if the peel distance or amount is too high, the next or subsequent pocket may be prematurely exposed, risking the loss of some of the medication disposed therein and resulting in an underdose at the next dispense. The tensioning mechanisms 151A, 151B also function to maintain the sheet tension of the top sheets 166A, 166B over the life of the device. The top sheets 166A, 166B must be under consistent tension to ensure proper operation of the inhalation device 100. The tension of each top sheet 166A, 166B is related to the force required by the user to operate the inhalation device 100 and move the mouthpiece cover 108. Therefore, ensuring consistent tension in the top sheets 166A, 166B provides a more consistent user experience over the life of the device. Maintaining consistent tension in the top sheets 166A, 166B also results in more consistent and lower peak mechanical stresses in the top sheets 166A, 166B and surrounding components, which reduces the risk of mechanical failure during use.

[0090]

[0142] The first tensioning mechanism 151A is associated with the first upper sheet take-up gear 150A for winding the upper sheet 166A of the first blister strip 160A, and the second tensioning mechanism 151B is associated with the second upper sheet take-up gear 150B (see FIGS. 4A and 4B) for winding the upper sheet 166B of the second blister strip 160B. Because the second tensioning mechanism 151B operates in the same manner, only the first tensioning mechanism 151A will be described herein for brevity. It will be apparent to those skilled in the art that certain features or components of the second tensioning mechanism 151B (i.e., cam surfaces described herein) may 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. Preferably, the first tensioning mechanism 151A and the second tensioning mechanism 151B use several components of the same design (i.e., the compression spring and winding hub described herein), which can reduce manufacturing and assembly costs compared to other inhalation devices where all components must be manufactured separately for each side of the device in order to operate in opposite directions.

[0091]

[0143] The tensioning mechanism 151A includes a first upper sheet take-up gear 150A, a take-up hub 152A having a hook 153A integrally formed therewith or secured thereto, a base 154A having a cam surface 155A integrally formed therewith or secured thereto, a nut 156A, a shaft 157A, and a compression spring 158A extending or disposed between the nut 156A and the upper end of the take-up hub 152A. The compression spring 158A biases the nut 156A downward toward the base 154A and into the cam surface 155A. The compression spring 158A is disposed around or around the shaft 157A and is longitudinally or axially adjacent to the nut 156A, and the take-up hub 152A is disposed around or around the nut 156A and compression spring 158A. Stated another way, the take-up hub 152A surrounds or encircles the nut 156A and compression spring 158A housed therein.

[0092]

[0144] The top sheet 166A of the first blister strip 160A is secured or attached to the take-up hub 152A via the hook 153A so that as the take-up hub 152A rotates, the top sheet 166A of the first blister strip 160A wraps around it. The hook 153A is configured to be attached to a leading end of the top sheet 166A so that rotation of the take-up hub 152A results in the top sheet 166A wrapping or wrapping around the take-up hub 152A. As the take-up hub 152A completes multiple rotations over the life of the inhalation device 100, the top sheet 166A of the first blister strip 160A wraps around itself multiple times, increasing its radial position on the take-up hub 152A; i.e., the radial distance of each subsequent wrap of the top sheet 166A from the take-up hub 152A increases with each wrap. Because the rotation of the base 154A corresponds to the 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 is peeled away from the bottom sheet 162A is determined by the tangential movement of the top sheet 166A of the first blister strip 160A on the take-up hub 152A. This tangential movement can be calculated as θ*r, where θ is the angle of rotation 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. Thus, as the radial position of the top sheet 166A of the first blister strip 160A increases, this tangential distance increases for a given rotation of the take-up hub 152A, causing the top sheet 166A of the first blister strip 160A to peel further away from the bottom sheet 162A later in the device's life without changing the mechanism. This is known as the wrap effect and is illustrated by a comparison of Figures 12A and 12B. Figure 12A is a schematic diagram of the first blister strip 160A early in the device's life, and Figure 12B is a schematic diagram of the first blister strip 160A later in the device's life. Figure 12B shows how the effective diameter of the take-up hub 152A increases as the first blister strip 160A wraps around the take-up hub 152A.

[0093]

[0145] To ensure that the top sheet 166A of the first blister strip 160A is peeled off the same amount for each dose and to compensate for winding effects, the tensioning mechanism 151A includes a cam surface 155A, a nut 156A, and a compression spring 158A. The function of the cam surface 155A, the nut 156A, and the compression spring 158A is to provide a constant driving tension to the top sheet 166A throughout the entire strip length. As described in more detail herein, increasing the 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 compressive force of the compression spring 158A is transferred to a torque applied to the take-up hub 152A.

[0094]

[0146] The structure of the tensioning mechanism 151A will be described in more detail with reference to Figures 13B to 13D. The base 154A is attached to or integrally formed with the first upper sheet take-up gear 150A, and rotates as an assembly when the first upper sheet take-up gear 150A is driven to rotate. For example, the base 154A may include a plurality of gear teeth integrally formed or fixed to its outer circumferential surface to form the first upper sheet take-up gear 150A. The shaft 157A extends from the base 154A and is attached to or integrally formed with the base 154A, and rotates together with the base 154A. As a result, when the first upper sheet take-up gear 150A is driven to rotate, the shaft 157A, the base 154A, and the first upper sheet take-up gear 150A rotate as an assembly.

[0095]

[0147] Nut 156A is disposed between take-up hub 152A and base 154A and is coupled to each of take-up hub 152A and base 154A. Nut 156A is disposed around shaft 157A and is coupled to base 154A via at least one inwardly extending rib 119A that protrudes or extends radially inward from the inner circumferential surface of nut 156A. In one embodiment, nut 156A includes multiple inwardly extending ribs 119A that act as cam followers. The multiple inwardly extending ribs 119A are preferably circumferentially spaced apart in equal increments. More specifically, as best shown in FIG. 13C , inwardly extending rib 119A of nut 156A is disposed on and engages cam surface 155A of base 154A. Additionally, nut 156A is coupled to take-up hub 152A via splined connection 159A such that take-up hub 152A rotates with nut 156A without permitting relative rotation therebetween. Stated another way, due to splined connection 159A, take-up hub 152A is rotationally locked to nut 156A such that nut 156A and take-up hub 152A rotate as an assembly. As best shown in FIG. 13C , splined connection 159A includes outwardly extending ribs 117A that protrude or extend radially outward from the outer periphery of nut 156A and are received within axial slots 115A in take-up hub 152A. The outwardly extending ribs 117A are permitted to slide or move axially along the axial slots 115A such that the nut 156A is permitted to slide or move axially relative to the take-up hub 152A, but the outwardly extending ribs 117A do not allow the nut 156A to rotate relative to the hub 152A.

[0096]

[0148] When the base 154A rotates in the second opposite direction with the first upper sheet take-up gear 150A, the nut 156A and 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 rotates in the second opposite direction via engagement between the inwardly extending rib 119A of the nut 156A and the cam surface 155A. As shown in FIG. 14D , the cam surface 155A includes alternating sections of a vertical surface 111A and an angled or inclined surface 113A. The vertical surface 111A extends generally parallel to the longitudinal axis of the shaft 157A. When base 154A is rotationally driven in a second, opposite direction (i.e., counterclockwise in this embodiment), nut 156A and take-up hub 152A, which are rotationally locked thereto, rotate in the second, opposite direction with base 154A. The interaction between compression spring 158A, nut 156A, and cam surface 155A applies torque to nut 156A from cam surface 155A in a direction that pushes nut 156A down onto cam surface 155A. Compression spring 158A presses nut 156A against inclined surface 113A of cam surface 155A, resulting in a torque acting on take-up hub 152A that drives take-up hub 152A in the second, opposite direction. As a result of this interaction when base 154A moves counterclockwise, nut 156A and take-up hub 152A also rotate counterclockwise with base 154A. Those skilled in the art will appreciate that the pattern of cam surface 155A is exemplary. Threads or other angled surfaces can be utilized as cam surface 155A.

[0097]

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

[0098]

[0150] In addition to the torque applied to nut 156A from cam surface 155A, there is also an opposing torque acting on nut 156A from its interaction with take-up hub 152A via outwardly extending ribs 117A. This opposing torque results from tension in upper seat 166A acting to apply a torque to take-up hub 152A. The two opposing torques on nut 156A are balanced, and therefore compression spring 158A (via nut 156A and cam surface 155A) effectively counterbalances the tension in upper seat 166A. As the tension in upper seat 166A increases, nut 156A moves further up cam surface 155A, increasing the spring force of compression spring 158A to compensate for the increased tension.

[0099]

[0151] More specifically, due to the wrapping effect described above, as the take-up hub 152A rotates, the radial position of the top sheet 166A of the first blister strip 160A increases. As a result of this increased radial position, the take-up hub 152A attempts to peel a longer length of the top sheet 166A, and the tension on the top sheet 166A increases due to the change in the peel angle between the top sheet 166A of the first blister strip 160A and the bottom sheet 162A of the first blister strip 160A. As the tension on the top sheet 166A increases, the torque that the top sheet 166A applies to the take-up hub 152A also increases. Rather than continuing to increase in torque, the take-up hub 152A begins to rotate in a second direction relative to the base 154A, causing the nut 156A to spiral up the cam surface 155A of the base 154A, thereby compressing the compression spring 158A. More specifically, when take-up hub 152A and its rotationally locked nut 156A begin to rotate in a second direction due to increased tension on top seat 166A, base 154A and cam surface 155A remain stationary, while inwardly extending rib 119A of nut 156A moves along inclined surface 113A of cam surface 155A toward compression spring 158A, i.e., above cam surface 155A. Compression spring 158A compresses as nut 156A presses against it. As nut 156A moves relative to base 154A, outwardly extending rib 117A of nut 156A is permitted to move axially within axial slot 115A of take-up hub 152A, causing nut 156A to also move axially relative to take-up hub 152A. Thus, rotation of take-up hub 152A relative to base 154A results in axial movement of nut 156A relative to take-up hub 152A and base 154A, and further axial movement of nut 156A toward compression spring 158A axially compresses compression spring 158A. Because take-up hub 152A is rotationally locked to nut 156A via splined connection 159A, nut 156A converts the axial force of compression spring 158A into torque on take-up hub 152A.The combination of compression spring 158A, nut 156A, and cam surface 155A thereby provides a torque that counteracts or opposes relative rotation between take-up hub 152A and base 154A, which acts to maintain consistent tension in top sheet 160A.

[0100]

[0152] The take-up hub 152A is axially constrained relative to the base 154A via a clip or retaining feature 149A disposed between the shaft 157A and the take-up hub 152A. More specifically, because the compression spring 158A acts to axially separate the take-up hub 152A and the base 154A, the retaining feature 149A (best shown in FIG. 13B) is disposed between the upper 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 feature 149A may be a clip, bayonet, or other component suitable for maintaining the correct relative axial position between the take-up hub 152A and the base 154A. In another embodiment (shown here), the retaining feature may be mounted inside the housing 102 to maintain the correct relative axial position between the take-up hub 152A and the base 154A.

[0101]

[0153] FIG. 13E illustrates how the position of nut 156A changes over the life of the device. In its initial assembled state, shown in the image on the left, nut 156A rests on the lower end of cam surface 155A prior to attachment of take-up hub 152A to first blister strip 160A. Cam surface 155A is designed so that in this position, no torque develops between take-up hub 152A and base 154A, even with the potential axial force from compression spring 158A. When the device is assembled, top sheet 166A is assembled under some tension to ensure effective release from the first dose, resulting in nut 156A lifting cam surface 155A slightly away from vertical surface 111A of cam surface 155A. More specifically, as shown in the middle image, when the device is assembled, top sheet 166A is attached to take-up hub 152A, and as take-up hub 152A rotates relative to base 154A, nut 156A moves up cam surface 155A. Compression spring 158A is deflected or slightly compressed from its uncompressed length so that compression spring 158A has a preload force. The preload force ensures that the tension in top sheet 166A of first blister strip 160A is high enough to peel top sheet 166A from bottom sheet 162A of first blister strip 160A at the beginning of device life. The specifications of the compression spring 158A and the angle of the cam surface 155A should be configured to provide a minimum tension on the top sheet 166A of the first blister strip 160A that is higher 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 that is counteracted by the tension in the top sheet 166A. Over the life of the inhalation device 100, as shown in the image to the right, the tension in the top sheet 166A of the first blister strip 160A increases.The increased tension in the upper seat 166A causes the nut 156A to move further up the cam surface 155A, so that the increased tension in the upper seat 166A is balanced by further deflection of the compression spring 158A.

[0102]

[0154] The angle or slope of each inclined surface 113A of cam surface 155A is configured to maintain consistent sheet tension on top sheets 166A, 166B over the life of the device. As discussed above, top sheets 166A, 166B must be under consistent tension to ensure proper operation of inhalation device 100. Generally, the angle or slope of each inclined surface 113A of cam surface 155A is selected to ensure that nut 156A moves along cam surface 155A of base 154A during operation of inhalation device 100 and does not move past or pass over vertical surface 111A. In one embodiment, inclined surface 113A of cam surface 155A extends at an angle between 35 degrees and 55 degrees relative to the longitudinal axis of base 154A. In one embodiment, inclined surface 113A of cam surface 155A extends at an angle between 40 degrees and 50 degrees relative to the longitudinal axis of base 154A. In one embodiment, inclined surface 113A of cam surface 155A extends at an angle of approximately 45 degrees relative to the longitudinal axis of base 154A, including a tolerance of approximately 3 degrees as used herein. In one embodiment, inclined surface 113A of cam surface 155A has a slope of 0.70 to 1.0. In one embodiment, inclined surface 113A of cam surface 155A has a slope of 0.80 to 0.95. In another embodiment, inclined surface 113A of cam surface 155A has a slope of 0.7 to 1.4. In another embodiment, inclined surface 113A of cam surface 155A has a slope of 1.0 to 1.4. The slope of inclined surface 113A of cam surface 155A may be constant over the length of the inclined surface or may vary over the length of the inclined surface.

[0103]

[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. Generally, the larger the radial width of the inclined surfaces 113A of the cam surface 155A, the greater the friction between the components, and the smaller the radial width of the inclined surfaces 113A of the cam surface 155A, the greater the likelihood that the nut 156A will undesirably fall off the cam surface 155A. In one embodiment, each inclined surface 113A of the cam surface 155A has a radial width between 1 mm and 3 mm. In one embodiment, each inclined surface 113A of the cam surface 155A has a radial width between 1.5 mm and 2.5 mm. In one embodiment, each inclined surface 113A of the cam surface 155A has a radial width of approximately 2 mm, which, as used herein, includes a tolerance of approximately 0.2 mm.

[0104]

[0156] 14A-14D, counter subassembly 134 will be described in more detail. Dispensing subassembly 120 preferably directly drives counter subassembly 134, such that the dose counter is automatically incremented simultaneously with a medication dose being indexed or delivered by inhalation device 100. Thus, beyond manipulating mouthpiece cover 108 to activate dispensing subassembly 120, the user does not need to perform any additional operational steps to update the dose counter. Because the dose counter is automatically incremented when mouthpiece cover 108 is opened, it is intuitive to the user what the dose counter pertains to.

[0105]

[0157] Counter subassembly 134 includes a first count wheel or units ring 140 and a second counting component or tens mechanism 136. First count wheel 140 is driven from dispensing subassembly 120 of inhalation device 100 to rotate a fixed angle per dose, in this embodiment, displaying the second digit of a two-digit number of available dose counts. Second count component 136 is intermittently driven from first count wheel 140 to rotate a fixed angle per revolution of first count wheel 140, as described in more detail below. In this embodiment, second count component 136 displays the first digit of a two-digit number of available dose counts. In this manner, first count wheel 140 and second counting component 136 collectively display the number of doses remaining in inhalation device 100, as shown in FIGS. 14A and 14B. While the counter subassembly embodiment described herein displays a two-digit number, those skilled in the art will appreciate that if the total number of doses in the inhalation device exceeds 100, the count indicia may be modified to display a three-digit number.

[0106]

[0158] The front or indicia-bearing face or surface 141 of the first count wheel 140 includes count indicia disposed thereon, including units' or "ones'" digits. More specifically, as shown in Figures 14A and 14B, the count indicia of the first count wheel 140 include the numbers 0, 1, 2, 3, 4, 5, 6, 7, 8, and 9 in a circular pattern near the outer periphery of the indicia-bearing face 141. The angle between each digit is the same as the rotation angle of the first count wheel 140 per dose. The indicia-bearing face 141 is planar.

[0107]

[0159] The front or indicia-bearing face or surface 137 of the second count component 136 includes count indicia disposed thereon, including "tens" digits. The count indicia of the second count component 136 include the digits 3, 2, and 1, and may also include a single flag SF and a double flag DF near the outer periphery of the indicia-bearing face 137. The angle between each count indicia or digit is the angle of rotation of the second count component 136 per rotation of the first count wheel 140. The indicia-bearing face 137 is planar.

[0108]

[0160] The display window 104 in the housing 102 is positioned such that one number on the first count wheel 140 and one number on the second count component 136 are visible within the display window and adjacent to each other to form a two-digit number. The displayed number on the second count component 136 reflects or tracks the number of "tens" of doses remaining in the inhalation device 100, while the displayed number on the first count wheel 140 reflects or tracks the number of "units" of doses remaining. When there are fewer than ten doses remaining, the second count component 136 displays a single flag SF in the display window 104 instead of or in place of a zero. In one embodiment, for example, the single flag SF may be a colored block with no numbers on it to indicate to the user that they are nearing the end of the available doses in the inhalation device 100. When the number of doses remaining reaches zero, the second count component 136 displays a double flag DF in the display window 104 instead of a number. In one embodiment, for example, the double flag DF may be a colored block with no numbers thereon that covers the numbers on the first count wheel 140 to provide clear visual feedback to the user that no doses remain in the inhalation device 100. The double flag DF is configured to cover the numbers on the first count wheel 140 when no doses remain in the inhalation device 100.

[0109]

[0161] 14A-14D, the units or "units" digits are circumferentially arranged in descending order in a first direction on the first count wheel 140, and the "tens" digits are arranged in descending order in a second, opposite direction about the circumference of the second counting component 136. While the counter subassembly described herein indicates the number of doses remaining in the inhalation device 100, those skilled in the art will appreciate that the counter subassembly may be modified to indicate the number of doses delivered by the inhalation device by reversing the order of the count indicia arranged on the counting subassembly.

[0110]

[0162] 14C and 14D, the structure and operation of the first count wheel 140 and second counting component 136 will now be described in more detail. FIG. 14C is a cross-sectional view taken along line CC in FIG. 14B, which is along a location midway between the indicia display face and the opposite rear face of the counting subassembly. FIG. 14D is a cross-sectional view taken along line DD in FIG. 14C, adjacent the opposite rear face of the counting subassembly. The relative terms "front" and "rear" are used herein for illustrative purposes only and relate to how the inhaler device is typically positioned by a user during use, with the front face of the inhaler device containing the display window for the counter mechanism.

[0111]

[0163] The first count wheel 140 is an annular or ring-shaped component having a front or indicia bearing surface 141 and an opposite back surface containing a counter gear 148, as best seen in the cross-sectional view of FIG. 14D. The counter gear 148 may be integrally formed on or attached to the first count wheel 140. An outer circumferential surface or portion 143 extends between the front and back surfaces of the first count wheel 140. The outer circumferential side portion 143 may be stepped, having a smaller diameter along the back surface of the first count wheel 140 and a larger diameter along the front surface of the first count wheel 140. The stepped nature of the outer circumferential side portion 143 is evident by comparing their relative diameters in FIGS. 14C and 14D. Stated differently, the indicia bearing surface 141 of the first count wheel 140 has a larger outer diameter than the counter gear 148.

[0112]

[0164] Adjacent to the counter gear 148, the first count wheel 140 includes a single tooth or protrusion 142 extending radially outward from an outer circumferential side 143. Along the front or indicia bearing face 141 of the first count wheel 140, the outer circumferential side 143 is generally circular with a clearance notch or recess 145 formed around the single tooth 142. The function of the clearance recess 145 is described in more detail below. In alternative embodiments (not shown), the first count wheel 140 may include two or more single teeth or protrusions 142. Thus, while at least one single tooth or protrusion is required, and a single tooth is deemed sufficient, advantageously simplifying the design of the first count wheel 140 and reducing material costs, embodiments may include more than two teeth or protrusions.

[0113]

[0165] The second count component 136 is configured to rotate about a pivot point 147. The second count component 136 is a non-annular or partial disc component having a front or indicia display surface 137 and an opposite back surface including a plurality of notches 138, as shown in the cross-sectional views of FIGS. 14C and 14D. An outer surface or outer portion 139 extends between the front and back surfaces of the second count component 136. The outer surface 139 may be stepped, having a smaller radial dimension along the back surface of the second count component 136 and a larger radial dimension along the front surface of the second count component. The stepped nature of the outer portion 139 is apparent by comparing their relative diameters in FIGS. 14B and 14C.

[0114]

[0166] A plurality of notches 138 are formed in an outer portion 139 of the second counting component 136 and do not penetrate the front or indicia-bearing surface 137. In one embodiment, the second counting component 136 includes four notches 138, although the number of notches is exemplary and depends on the capacity or total number of doses available within the inhalation device 100. Each notch 138 extends radially inward toward a pivot point 147 of the second counting component 136 and is configured to mate with or receive a single tooth 142 of the first counting wheel 140. The outer portion 139 of the second counting component 136 may be considered to include a plurality of segments 135, with each segment 135 extending between two adjacent or neighboring notches 138. Along each segment 135 , the outer side 139 of the second counting element 136 is concave, forming an inverted curved or arcuate depression 133 that matches the outer periphery 143 of the first counting wheel 140 .

[0115]

[0167] The first count wheel 140 is driven by the second bottom sheet take-up gear 128B of the dispensing subassembly 120 so that the first count wheel 140 rotates a fixed angle each time a dose is dispensed. More specifically, a transfer gear 144 is attached to the opposite end of the second spindle 129B of the second bottom sheet take-up gear 128B, such that the transfer gear 144, the second spindle 129B, and the second bottom sheet take-up gear 128B rotate simultaneously as an assembly. This causes the transfer gear 144 to rotate in a second, opposite direction together with the second bottom sheet take-up gear 128B when the mouthpiece cover 108 is opened. The transmission gear 144 engages with or directly drives the idler gear 146 to rotate it in a first direction, and the idler gear 146 engages with or directly drives the counter gear 148 to rotate it in a second, opposite direction. Thus, the counter gear 148 rotates in the same direction as the transmission gear 144. As will be apparent to those skilled in the art, rotation of the transmission gear 144 and the counter gear 148 in the same direction may also be achieved via a gear train in which the transmission gear 144 directly drives the counter gear 148 in the same direction. For example, as depicted in FIGS. 14B-14D , the desired rotation scheme is achieved when the counter gear 148 is an internal gear and the transmission gear 144 is a spur or planetary gear, whereby the transmission gear 144 engages with or directly drives the internal counter gear 148 in the same direction. The first count wheel 140 is attached to the counter gear 148 and rotates together as an assembly so that when the mouthpiece cover 108 is opened, the first count wheel 140 rotates in a second, opposite direction. Accordingly, various suitable gear trains may be utilized herein so that the transfer gear 144 and the counter gear 148 rotate in the same direction.

[0116]

[0168] 14C , the second count component 136 is positioned adjacent or next to an outer peripheral side 143 of the first count wheel 140 such that a single tooth 142 of the first count wheel 140 engages with a notch 138 of the plurality of notches 138 of the second count component 136 once per rotation of the first count wheel 140, causing the second count component 136 to intermittently rotate. Stated another way, with each complete rotation of the first count wheel 140, the single tooth 142 engages with a notch 138 of the second count component 136, turning or rotating the second count component 136 a fixed amount. Thus, there is a fixed rotation of the second count component 136 once per rotation of the first count wheel 140. The first count wheel 140 directly drives the second count component 136, so that the second count component 136 rotates in the opposite direction to the first count wheel 140. In the embodiment of Figures 14A-14D, the second count component 136 is configured to rotate in a first direction and the first count wheel 140 is configured to rotate in a second, opposite direction. The second count component 136 is stationary and does not rotate when the single tooth 142 of the first count wheel 140 is not engaged with the notch 138 of the second count component 136.

[0117]

[0169] The second counting component 136 is disposed adjacent to or alongside the first counting wheel 140 in a common plane, and therefore the second counting component 136 rotates on a different axis of rotation than the first counting wheel 140. In other words, the first counting wheel 140 rotates about a first axis, and the second counting component 136 rotates about a second axis, which is parallel to and spaced apart from the first axis.

[0118]

[0170] As mentioned above, along each segment 135, the outer side 139 of the second count component 136 is concave, forming an arcuate recess 133 that mates with the outer periphery 143 of the first count wheel 140. As best shown in FIG. 14C , the geometry of the arcuate recess 133 matches the circular profile of the first count wheel 140 to prevent the second count component 136 from unintentionally rotating when not engaged with the first count wheel 140. In particular, this geometry or profile of the outer side 139 of the second count component 136 ensures that the second count component 136 does not rotate and remains stationary when a single tooth 142 of the first count wheel 140 is not engaged with one of the notches 138 of the second count component 136. Conversely, when a single tooth 142 of the first count wheel 140 engages or is received within one of the notches 138 of the second count component 136, the clearance recess 145 of the first count wheel 140 allows the second count component 136 to briefly rotate with the first count wheel 140 to change the tens digit display.

[0119]

[0171] While having a relatively large, clear indication of the number of available doses remaining in the inhaler device is an important consideration for readability, there is often a trade-off between the size of the dose counter display and the space the dose counter mechanism occupies within the inhaler device housing. The counter subassembly 134 preferably divides the two-digit number of available doses among multiple components, making it easier to achieve a larger number size within the same amount of space within the inhaler device housing. Additionally, the counter subassembly 134 does not require any type of detent feature to hold or maintain its position. For example, other dose counter mechanisms utilize a flexible arm as a detent feature to hold the position of the dose counting mechanism, and some force is required to deflect the flexible arm to allow the dose counting mechanism to increment. Such detent features increase the operating force of the device, which is undesirable. The counter subassembly 134 also does not require any type of intermediate component between the counting components. Driving the second counting component 136 directly from the first counting wheel 140 simplifies the counter subassembly 134, minimizing the overall number of components in the inhalation device 100 and reducing the overall cost and complexity of the inhalation device 100. Additionally, the elimination of intermediate components between the counting components means that there is a shorter tolerance chain for alignment between the first counting wheel 140 and the second counting component 136, which results in more consistent alignment between the first and second digits of a two-digit number on the display.

[0120]

[0172] 14A-14D, as best shown in FIG. 14B, the front or indicia display surface 137 of the second count component 136 overlaps or covers a portion of the front or indicia display surface 141 of the first count wheel 140. Thus, the "units" number on the first count wheel 140 and the "tens" number on the second count component 136 are not coplanar. In other words, the "units" number on the first count wheel 140 and the "tens" number on the second count component 136 are on different planes or levels, with the "tens" number being elevated relative to the "units" number or being disposed closer to the display window 104 of the inhalation device 100.

[0121]

[0173] 15A and 15B illustrate another embodiment of a counter subassembly 1534, in which the “tens” digit is flush or at the same level as the “units” digit. The counter subassembly 1534 is the same as the counter subassembly 134 described above, except for the differences noted herein. One advantage of the counter subassembly 1534 configuration is having the “tens” digit at the same level as the “units” digit, which can improve readability of the display, especially at shallow viewing angles. A circular boss 1501 is integrally formed with or affixed to the first count wheel 1540, raising or elevating the “units” digit thereon to the same level as the “tens” digit on the second count component 1536. The circular boss 1501 forms the front or indicia display face or surface 1541 of the first count wheel 1540. Additionally, the double flag DF on the second count component 1536 is disposed on a raised or stepped level 1503 integrally formed with or affixed to the second count component 1536 such that, at the end of the device's life, the double flag DF is configured to cover the numbers on the first count wheel 1540, as shown in FIG. 15B. More specifically, the raised or stepped level 1503 extends radially outward from an outer surface or outer portion 1539 of the second count component 1536, such that the raised or stepped level 1503 extends above or overlaps the numbers on the first count wheel 1540 at the end of the device's life. In this embodiment, the front or indicia-bearing face or surface 1537 of the second count component 1536 is flush with the front or indicia-bearing face 1541 of the first count wheel 1540, except as noted above for the raised or stepped level 1503.

[0122]

[0174] Another embodiment of a counter subassembly 1634 that may be utilized within inhalation device 100 is depicted in Figures 16A and 16B. Counter subassembly 1634 includes a first count wheel or units ring 1640 and a second counting component or tens mechanism 1636. Counter subassembly 1634 is similar to counter subassembly 134, but replaces rotatable second counting component 136 with a slider component that moves along a linear path.

[0123]

[0175] Similar to counter subassembly 134, dispensing subassembly 120 preferably directly drives counter subassembly 1634, thereby automatically incrementing the dose counter simultaneously with medication doses indexed or delivered by inhalation device 100. First count wheel 1640 is driven from dispensing subassembly 120 of inhalation device 100 to rotate a fixed angle for each dose and display the second digit of a two-digit number of available dose counts. First count wheel 1640 is identical to first count wheel 140, except that first count wheel 1640 does not include clearance recess 145. First count wheel 1640 includes a single tooth or protrusion 1642 extending radially outward from its outer circumferential surface or outer portion 1643. In another embodiment herein (not shown), first count wheel 1640 may include more than a single tooth or protrusion 1642. Therefore, at least one single tooth or protrusion is required, and although a single tooth is believed to be sufficient and preferably simplifies the design and reduces the material costs of the first count wheel 1640, embodiments of the present invention may include two or more teeth or protrusions.

[0124]

[0176] The second count component 1636 is a slider element that is intermittently moved by the first count wheel 1640 to move or translate a fixed amount per revolution of the first count wheel 1640, as described in more detail below. The second count component 1636 displays the first of a two-digit number of the available dose count. Thus, the first count wheel 1640 and the second count component 1636 collectively display the number of doses remaining in the inhalation device 100, as shown in FIG. 16A . The front or indicia-displaying face or surface 1637 of the second count component 1636 is provided with count indicia, including "tens" digits. The count indicia of the second count component 1636 include the numbers 3, 2, and 1, and may also include a single flag SF and a double flag DF near the outer periphery of the indicia-displaying face 1637. The distance between each mark is the amount of translation of the second count component 1636 per revolution of the first count wheel 1640. The indicia display surface 1637 is planar.

[0125]

[0177] The display window 104 in the housing 102 is positioned such that one number on the first count wheel 1640 and one number on the second count component 1636 are visible within the display window and adjacent to each other to form a two-digit number. The displayed number on the second count component 1636 reflects or tracks the number of "tens" of doses remaining in the inhalation device 100, while the displayed number on the first count wheel 1640 reflects or tracks the number of "units" of doses remaining. When there are fewer than 10 doses remaining, the second count component 1636 displays a single flag SF in the display window 104 instead of or in place of a zero. In one embodiment, for example, the single flag SF may be a colored block with no numbers on it to indicate to the user that they are nearing the end of the available doses in the inhalation device 100. When the number of doses remaining reaches zero, the second count component 1636 displays a double flag DF in the display window 104 instead of a number. In one embodiment, for example, the double flag DF may be a colored block with no numbers thereon that covers the numbers on the first count wheel 1640 to provide clear visual feedback to the user that no doses remain in the inhalation device 100. The double flag DF is configured to cover the numbers on the first count wheel 1640 when no doses remain in the inhalation device 100.

[0126]

[0178] 16A and 16B, the units or "ones" digits are arranged circumferentially on the first count wheel 1640 in descending order in a first direction toward the mouthpiece 110 of the inhalation device, and the "tens" digits are arranged in descending order in an upward direction on the second count component 1636. While the counter subassembly described herein indicates the number of doses remaining in the inhalation device 100, those skilled in the art will appreciate that the counter assembly may be modified to indicate the number of doses delivered by the inhalation device by reversing the order of the count indicia arranged on the counting subassembly.

[0127]

[0179] 16A , the front or indicia display surface 1637 of the second count component 1636 overlaps or covers a portion of the front or indicia display surface 1641 of the first count wheel 1640. Thus, the "units" number on the first count wheel 1640 and the "tens" number on the second count component 1636 are not coplanar. In other words, the "units" number on the first count wheel 1640 and the "tens" number on the second count component 1636 are on different levels, with the "tens" number elevated relative to the "units" number and disposed near the display window 104 of the inhalation device 100.

[0128]

[0180] Referring now to Figure 16B, the structure and operation of the first count wheel 1640 and the second counting component 1636 will be described in more detail. Figure 16B is a cross-sectional view taken along line BB of Figure 16A, which is along a position midway between the indicia display face and the opposite rear face of the counting subassembly. The relative terms "front" and "rear" are used herein for illustrative purposes only and relate to how the inhaler device is typically positioned by a user during use with the front of the inhaler device containing the display window for the counter mechanism.

[0129]

[0181] The second count component 1636 is a generally rectangular, non-annular component having a front or indicia-bearing surface 1637 and an opposite back surface including a plurality of rack teeth 1638, as shown in the cross-sectional view of FIG. 16B. An outer surface or outer portion 1639 extends between the front and back surfaces of the second count component 1636. The outer portion 1639 may be stepped, having a smaller width dimension along the back surface of the second count component 1636 and a larger width dimension along the front surface of the second count component. The stepped nature of the outer portion 1639 is apparent by comparing its relative widths in FIGS. 16A and 16B.

[0130]

[0182] The plurality of rack teeth 1638 are formed on an outer portion 1639 of the second counting component 136 and do not penetrate the front or indicia display surface 1637. In one embodiment, the second counting component 1636 includes four rack teeth 1638, although the number of rack teeth is exemplary and depends on the capacity or total number of doses available within the inhalation device 100. The plurality of rack teeth 1638 are aligned along the longitudinal axis L of the inhalation device. A 16B), with each rack tooth 1638 extending outward from outer portion 1639 in a direction toward a single tooth 1642 of first count wheel 1640.

[0131]

[0183] The second count component 1636 is positioned adjacent or next to the outer periphery 1643 of the first count wheel 1640 such that a single tooth 1642 on the outer edge of the first count wheel 1640 engages or contacts a rack tooth 1638 of the plurality of rack teeth 1638 of the second count component 1636 once per rotation of the first count wheel 1640, causing the second count component 1636 to translate. In other words, with each full rotation of the first count wheel 1640, the single tooth 1642 engages with a rack tooth 1638 of the second count component 1636, causing the second count component 1636 to move or translate a fixed amount. The first count wheel 1640 indexes the position of the second count component 1636 by driving the second count component 1636 along a linear path. Thus, the second counting component 1636 moves linearly a fixed distance once for each revolution of the first counting wheel 1640. The second counting component 1636 is disposed adjacent to or alongside the first counting wheel 1640 in a common plane. The first counting wheel 1640 rotates about a first or central axis of the first counting wheel, and the second counting component 1636 rotates about a second axis, i.e., an axis L extending longitudinally of the inhalation device. A16A and 16B, the first count wheel 1640 is configured to rotate in a counterclockwise direction, and the second count component 1636 is configured to move or translate downwardly away from the mouthpiece 110 of the inhalation device. Due to interactions with the housing 102, which will be described in more detail below, the second count component 1636 is stationary and does not translate when a 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 component 1636.

[0132]

[0184] In this embodiment, the housing 102 of the inhalation device 100 includes a flexible arm 1605 extending from its inner surface. The flexible arm 1605 is configured to interact with the second count component 1636 and maintain the position of the second count component 1636 when the second count component 1636 is not engaged with the first count wheel 1640. The second count component 1636 includes a plurality of notches 1607 on its second outer portion or outer surface 1609. The second outer surface 1609 is opposite the outer surface 1639 of the second count component 1636. The flexible arm 1605 includes a detent 1661 thereon, which is configured to be received within or mate with each of the plurality of notches 1607 of the second count component 1636. The flexible arm 1605 ensures that the second count component 1636 cannot move away from its currently indexed position until it is driven by the first count wheel 1640 with enough force to deflect the flexible arm 1605. The flexible arm 1605 also helps to maintain a consistent position of the second count component 1636 relative to the display window 104 of the inhalation device 100, resulting in more consistent alignment between the first and second digits of the two-digit number on the display.

[0133]

[0185] The counter subassembly 1634 can provide a more space-efficient layout compared to counters featuring two-wheel components. The counter subassembly 1634 also does not require any type of intermediate component between the counting components. Driving the second counting component 1636 directly from the first count wheel 1640 simplifies the counter subassembly 1634, minimizes the overall number of component parts of the inhalation device 100, and reduces the overall cost and complexity of the inhalation device 100. Furthermore, the elimination of intermediate components between the counting components means that there is a shorter tolerance chain for alignment between the first count wheel 1640 and the second counting component 1636, which results in more consistent alignment between the first and second digits of a two-digit number on the display.

[0134]

[0186] FIG. 17 illustrates another embodiment of a counter subassembly 1734 whose components are arranged differently than those of counter subassembly 1634. Counter subassembly 1734 includes a first count wheel or units ring 1740 and a second count component 1636. Counter subassembly 1734 is the same as counter subassembly 1634 described above, except for the differences noted herein. In this embodiment, first count wheel 1740 is driven by dispense subassembly 120 via gear teeth formed on its outer circumferential surface or outer portion 1743 rather than on its inner surface. Stated differently, in the embodiment of FIG. 17, counter gear (hidden in FIG. 17) includes external gear teeth instead of the internal gear teeth of counter subassemblies 134, 1634. Transfer gear 144 meshes with the external gear teeth of first count wheel 1740 and drives first count wheel 1740 to rotate in the opposite direction. As described above, when the mouthpiece cover 108 is opened, the transmission gear 144 rotates in the second opposite direction together with the second bottom sheet take-up gear 128B. In this embodiment, the transmission gear 144 engages with or directly drives the external gear teeth of the first count wheel 1740, causing it to rotate in the first direction. This causes the first count wheel 1740 to rotate in the first direction when the mouthpiece cover 108 is opened.

[0135]

[0187] The first count wheel 1740 is configured to rotate in a first direction such that the second count component 1636 moves or translates upward toward the inhaler mouthpiece 110. The "units" digits are circumferentially arranged on the first count wheel 1640 in descending order in a second, opposite direction, and the "tens" digits are arranged downwardly on the second count component 1636 in descending order, away from the inhaler mouthpiece 110.

[0136]

[0188] Additionally, rather than extending from an outer periphery 1743 of the first count wheel 1740, a single tooth 1742 extends from an inner periphery 1763 of the first count wheel 1740. The single tooth 1742 engages or contacts a rack tooth 1638 of the plurality of rack teeth 1638 of the second count component 1636 once per rotation of the first count wheel 1740, causing the second count component 1636 to translate. Stated another way, each time the first count wheel 1740 makes a complete rotation, the single tooth 1742 engages with a rack tooth 1638 of the second count component 1636, causing the second count component 1636 to move or translate 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 component 1636 to overlap or cover the first count wheel 1740 to a greater extent than in the embodiment of FIGS. 16A and 16B , thus potentially reducing the overall lateral space occupied by the counter sub-assembly 1734. There may be limitations on the space available for the dose counter mechanism, and this embodiment provides a space-efficient arrangement of the components of the counter sub-assembly. In another embodiment herein (not shown), the first count wheel 1740 may include more than a single tooth or protrusion 1742. Thus, while at least one single tooth or protrusion is required, and a single tooth is believed to be sufficient, preferably simplifying the design and reducing material costs of the first count wheel 1740, embodiments of the present invention may include two or more teeth or protrusions.

[0137]

[0189] Another embodiment of a counter subassembly 1834 that may be utilized within inhalation device 100 is depicted in Figures 18A and 18B. Counter subassembly 1834 includes a first count wheel or units ring 1840 and a second counting component or tens mechanism 1836. Similar to the previous embodiments described herein, first count wheel 1840 is driven from dispensing subassembly 120 of inhalation device 100 and configured to rotate a fixed angle per dose and display the second digit of a two-digit number of available dose counts. Second counting component 1836 is intermittently driven from first count wheel 1840 to rotate a fixed angle per revolution of first count wheel 1840. Second counting component 1836 displays the first digit of a two-digit number of available dose counts. Thus, the first count wheel 1840 and the second count component 1836 together indicate the number of doses remaining in the inhalation device 100, as shown in Figure 18A.

[0138]

[0190] The front or marking face or surface 1841 of the first count wheel 1840 is provided with count markings including units or "ones" digits. More specifically, as shown in FIG. 18A , the count markings of the first count wheel 1840 include the numbers 0, 1, 2, 3, 4, 5, 6, 7, 8, and 9 in a circular pattern near the outer periphery of the marking face 1841. The angle between each number is the same as the rotation angle of the first count wheel 1840 per dose. The marking face 1841 is planar.

[0139]

[0191] The front or indicia displaying face or surface 1837 of the second count component 1836 is provided with count indicia including "tens" digits. The count indicia of the second count component 1836 include the digits 3, 2, and 1, and may also include a single flag SF and a double flag DF near the outer periphery of the indicia displaying face 1837. The angle between each mark is the angle of rotation of the second count component 1836 per rotation of the first count wheel 1840. The indicia displaying face 1837 is planar.

[0140]

[0192] Similar to the previous embodiments described herein, the display window 104 in the housing 102 is positioned such that one number on the first count wheel 1840 and one number on the second count component 1836 are visible within the display window and adjacent to each other to form a two-digit number. The displayed number on the second count component 1836 reflects or tracks the number of "tens" of doses remaining in the inhalation device 100, while the displayed number on the first count wheel 1840 reflects or tracks the number of "units" of doses remaining. If there are fewer than 10 doses remaining, the second count component 1836 displays a single flag SF in the display window 104 instead of or in lieu of a zero. In one embodiment, for example, the single flag SF may be a colored block with no numbers thereon to indicate to the user that they are nearing the end of the available doses in the inhalation device 100. When the number of remaining doses reaches zero, the second counting component 1836 displays a double flag DF in place of a number in the display window 104. In one embodiment, for example, the double flag DF may be a colored block with no numbers on it that covers the number on the first count wheel 1840 to provide clear visual feedback to the user that no doses remain in the inhalation device 100. The double flag DF is configured to cover the number on the first count wheel 1840 when no doses remain in the inhalation device 100.

[0141]

[0193] 18A and 18B, the units or "tens" digits are circumferentially arranged in a second, opposite, descending order on the first count wheel 1840, and the "tens" digits are arranged in a second, opposite, descending order on the second counting component 1836. While the counter subassembly described herein indicates the number of doses remaining in the inhalation device 100, those skilled in the art will appreciate that the counter assembly may be modified to indicate the number of doses delivered by the inhalation device by reversing the order of the count indicia arranged on the counting subassembly.

[0142]

[0194] 18A , the front or indicia display surface 1837 of the second count component 1836 overlaps or covers a portion of the front or indicia display surface 1841 of the first count wheel 1840. Thus, the "units" number on the first count wheel 1840 and the "tens" number on the second count component 1836 are not coplanar. In other words, the "units" number on the first count wheel 1840 and the "tens" number on the second count component 1836 are on different planes or levels, with the "tens" number elevated relative to the "units" number and disposed near the display window 104.

[0143]

[0195] Referring now to Figure 18B, the structure and operation of the first count wheel 1840 and the second counting component 1836 will be described in more detail. Figure 18B is a cross-sectional view taken along line BB in Figure 18A adjacent the opposite rear side of the counting subassembly. The relative terms "front" and "rear" are used herein for illustrative purposes only and relate to how the inhaler device is typically positioned by a user during use with the front of the inhaler device containing the viewing window for the counter mechanism.

[0144]

[0196] The first count wheel 1840 is an annular or ring-shaped component having a front or indicia-bearing face 1841 and an opposite back face that includes a counter gear 1848. A single tooth 1842 extends from an inner circumferential surface 1863 of the first count wheel 1840 adjacent the counter gear 1848. The counter gear 1848 may be integrally formed on or attached to the first count wheel 1840. In another embodiment (not shown) herein, the first count wheel 1840 may include more than a single tooth or protrusion 1842. Thus, while at least one single tooth or protrusion is required, a single tooth is considered sufficient, preferably simplifying the design and reducing material costs of the first count wheel 1840, embodiments of the invention may include more than two teeth or protrusions.

[0145]

[0197] The second count component 1836 is configured to rotate about a pivot point 1847. The second count component 1836 is a non-annular or partially disc component having a front or indicia display face 1837 and an opposite back face that includes a second counter gear 1865. The second counter gear 1865 may be integrally formed on or attached to the second count component 1836. The second counter gear 1865 includes a plurality of gear teeth on its outer circumferential surface 1839, with each gear tooth of the second counter gear 1865 extending radially outward. The second counter gear 1865 of the second count component 1836 is non-concentric with the count gear 1848 of the first count wheel 1840.

[0146]

[0198] The first count wheel 1840 is indirectly driven by the second bottom sheet take-up gear 128B of the dispensing subassembly 120 so that the first count wheel 1840 rotates a fixed angle each time a dose is dispensed. More specifically, in this embodiment, the transmission gear 144 meshes with or directly drives the counter gear 1848 of the first count wheel 1840, driving the first count wheel 1840 to rotate in the opposite direction. As described above, when the mouthpiece cover 108 is opened, the transmission gear 144 rotates in the second opposite direction together with the second bottom sheet take-up gear 128B. Thus, in this embodiment, the transmission gear 144 meshes with or directly drives the external gear teeth of the first count wheel 1840, causing it to rotate in the first direction. This causes the first count wheel 1840 to rotate in the first direction when the mouthpiece cover 108 is opened.

[0147]

[0199] The second count component 1836 is positioned adjacent or next to the inner circumferential surface 1863 of the first count wheel 1840 such that a single tooth 1842 of the first count wheel 1840 engages with the second counter gear 1865 of the second count component 1836 once per rotation of the first count wheel 1840, causing the second count component 1836 to intermittently rotate. Stated another way, with each complete rotation of the first count wheel 1840, the single tooth 1842 engages with the second counter gear 1865 of the second count component 1836, turning or rotating the second count component 1836 a fixed amount. Thus, there is a fixed rotation of the second count component 1836 once per rotation of the first count wheel 1840. The first count wheel 1840 directly drives the second count component 1836, and the second counter gear 1865 is disposed within the first count wheel 1840 so that the second count component 1836 rotates in the same direction as the first count wheel 1840. In the embodiment of FIGS. 18A and 18B, the first count wheel 1840 and the second count component 1836 are each configured to rotate in a first direction. The second count component 1836 is stationary and does not rotate when a single tooth 1842 of the first count wheel 1840 is not engaged with the second counter gear 1865 of the second count component 1836.

[0148]

[0200] The second count component 1836 is disposed within the first count wheel 1840 in a common plane with the first count wheel 1840, but the second count component 1836 rotates on a different axis of rotation than the first count wheel 1840. Stated another way, the first count wheel 1840 rotates about a first axis, and the second count component 1836 rotates about a second axis, which is parallel to and spaced apart from the first axis. Thus, there is a constant rotation of the second count component 1836, on a different axis of rotation but in the same direction, once for every rotation of the first count wheel 1840. In this embodiment, the axis of rotation of the second count component 1836 is within the inner diameter of the first count wheel 1840, which is defined by the inner circumference of the first count wheel 1840. Having the second count component 1836 on a different axis of rotation than the first count wheel 1840 allows the markings on the second count component 1836 to be on a larger radius, which makes it easier to fit larger count markings thereon and improves readability.

[0149]

[0201] The arrangement of the components of the counter subassembly 1834 potentially reduces the overall lateral space occupied by the counter subassembly 1834 compared to the counter subassembly 134 described above. The space available for a dose counter mechanism may be limited, and this embodiment provides a space-efficient arrangement of the counter subassembly's components. The counter subassembly 1834 also does not require any type of intermediate component between the counting components. Driving the second counting component 1836 directly from the first count wheel 1840 simplifies the counter subassembly 1834, minimizing the overall component count of the inhalation device 100 and reducing the overall cost and complexity of the inhalation device 100. Furthermore, the elimination of intermediate components between the counting components means that there is a shorter tolerance chain for alignment between the first count wheel 1840 and the second counting component 1836, which results in more consistent alignment between the first and second digits of a two-digit number on the display.

[0150]

[0202] In this embodiment, the backplate of the counter subassembly 1845 includes a flexible arm 1805. The flexible arm 1805 is configured to interact with and maintain the position of the second count component 1836 when the second count component 1836 is not engaged with the first count wheel 1840. The flexible arm 1805 includes a detent 1861 thereon, which is configured to be received within or mate with a notch formed between adjacent gear teeth of the second counter gear 1865. The flexible arm 1805 ensures that the second count component 1836 cannot move away from its currently indexed position until it is driven by the first count wheel 1840 with sufficient force to deflect the flexible arm 1805. The flexible arm 1805 also helps maintain a consistent position of the second counting component 1836 relative to the display window 104 of the inhalation device 100, resulting in more consistent alignment between the first and second digits of the two-digit number on the display.

[0151]

[0203] While eliminating intermediate components between components of the counting subassembly as described above has advantages, the use of intermediate components may allow for greater flexibility in the design of the counter subassembly for different gear ratios and component positions. Because 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, it is desirable to increase the design flexibility of the counter subassembly to find an arrangement that best suits the other design elements. Accordingly, FIGS. 19A and 19B illustrate another embodiment of a counter subassembly 1934 that includes intermediate components. The counter subassembly 1934 includes a first count wheel or units ring 1940 and a second counting component 1936. The counter subassembly 1934 is the same as the counter subassembly 1834 described above, except for the differences noted herein. In this embodiment, an intermediate counter gear 1967 is disposed between a first counter gear 1948 formed with the first count wheel 1940 and a second counter gear 1965 formed with the second count component 1936. The intermediate counter gear 1967 transfers the rotation of the first count wheel 1940 to the second count component 1936 rather than the two components directly meshing with one another.

[0152]

[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 of the dispensing subassembly 120 so that the first count wheel 1940 rotates a fixed angle each time a dose is dispensed. As described above, when the mouthpiece cover 108 is opened, the transfer gear 144 rotates in a second, opposite direction together with the second bottom sheet take-up gear 128B. Thus, in this embodiment, the transfer gear 144 engages with or directly drives the external gear teeth of the external gear 1948 of the first count wheel 1940, causing it to rotate in a first direction. This causes the first count wheel 1940 to rotate in the first direction when the mouthpiece cover 108 is opened.

[0153]

[0205] The intermediate counter gear 1967 is positioned adjacent or next to the inner peripheral surface 1963 of the first count wheel 1940 so that a single tooth 1942 of the first count wheel 1940 engages the intermediate counter gear 1967 once per rotation of the first count wheel 1940. The intermediate counter gear 1967 is also positioned adjacent or next to the second counter gear 1965 of the second count component 1936 so that the second counter gear 1965 rotates with the intermediate counter gear 1967. Because the second counter gear 1965 of the second count component 1936 is always engaged with the intermediate counter gear 1967, the second count component 1936 rotates every time the intermediate counter gear 1967 rotates. Thus, for each full rotation of the first count wheel 1940, a single tooth 1942 engages the intermediate counter gear 1967, causing the second count component 1936 to rotate or turn a fixed amount. Thus, there is a fixed rotation of the second count component 1936, once for each rotation of the first count wheel 1940. Thus, in this embodiment, the first count wheel 1940 indirectly drives the second count component 1936 via the intermediate counter gear 1967. In the embodiment of FIGS. 19A and 19B, the first count wheel 1940 and the intermediate counter gear 1967 are each configured to rotate in a first direction, and the second count component 1936 is configured to rotate in a second, opposite direction. The second count component 1936 is stationary and does not rotate when the single tooth 1942 of the first count wheel 1940 is not engaged with the intermediate count gear 1967. In another embodiment herein (not shown), the first count wheel 1940 may include more than a single tooth or protrusion 1942. Thus, while at least one single tooth or protrusion is required, and a single tooth is believed to be sufficient, preferably simplifying the design and reducing material costs of the first count wheel 1940, embodiments of the invention may include two or more teeth or protrusions.

[0154]

[0206] 19A and 19B, the second count component 1936 rotates in the opposite direction to the first count wheel 1940 and the intermediate counter gear 1967. Thus, as shown in FIG. 19A, the units or "tens" digits are circumferentially arranged in descending order in a second, opposite or counterclockwise direction on the first count wheel 1940, and the "tens" digits are arranged in descending order in a first, or clockwise direction on the second count component 1836.

[0155]

[0207] Another embodiment of a counter subassembly 2034 that may be utilized within the inhalation device 100 is depicted in FIGS. 20A-20M. FIG. 20A illustrates the assembled counter subassembly 2034, and FIG. 20B illustrates an exploded view of the components of the counter subassembly 2034. 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 from the dispensing subassembly 120 of the inhalation device 100 and is configured to rotate a fixed angle per dose to display the second digit of a two-digit number of available dose counts. The second count wheel 2036 is intermittently driven from the first count wheel 2040 such that it rotates a fixed angle per rotation of the first count wheel 2040. The second count wheel 2036 displays the first of a two-digit number of the available dose count. Thus, the first count wheel 2040 and the second count wheel 2036 collectively display the number of doses remaining in the inhalation device 100, as shown in FIG. 20A. In addition to the first count wheel 2040 and the second count wheel 2036, the counter subassembly 2034 includes a backplate 2073, a cover 2075, and a transfer gear 2044. When assembled as shown in FIG. 20A, the first count wheel 2040, the second count wheel 2036, and the transfer gear 2044 are disposed between the backplate 2073 and the cover 2075 such that the cover 2075 overlaps or covers the first count wheel 2040, the second count wheel 2036, and the transfer gear 2044.

[0156]

[0208] The front or marking face or surface 2041 of the first count wheel 2040 is provided with count markings including units or "ones" digits. More specifically, as best shown in the exploded view of FIG. 20B, the count markings of the first count wheel 2040 include the numbers 0, 1, 2, 3, 4, 5, 6, 7, 8, and 9 in a circular pattern near the outer periphery of the marking face 2041. The angle between each digit is the same as the angle of rotation of the first count wheel 2040 per dose. The marking face 2041 is planar.

[0157]

[0209] The front or marking face or surface 2037 of the second count wheel 2036 is provided with count markings including "tens" digits. The count markings of the second count wheel 2036 include the digits 3, 2, and 1, and may also include a single flag SF and a double flag DF near the outer periphery of the marking face 2037. The angle between each marking is the angle of rotation of the second count wheel 2036 for each rotation of the first count wheel 2040. The marking face 2037 is planar.

[0158]

[0210] Similar to the previous embodiments described herein, the display window 2004 in the housing 102 is positioned so that one number on the first count wheel 2040 and one number on the second count wheel 2036 are visible within the display window and adjacent to each other to form a two-digit number. In this embodiment, the display window 2004 is generally circular, as described in more detail herein. The displayed number on the second count wheel 2036 reflects or tracks the number of "tens" of doses remaining in the inhalation device 100, while the displayed number on the first count wheel 2040 reflects or tracks the number of "units" of doses remaining. If there are fewer than 10 doses remaining, the second count wheel 2036 displays a single flag SF in the display window 2004 instead of or in lieu of a zero. In one embodiment, for example, the single flag SF may be a colored block with no numbers thereon to indicate to the user that they are nearing the end of the available doses in the inhalation device 100. When the number of remaining doses reaches zero, the second count wheel 2036 displays a double flag DF in place of a number in the display window 2004. In one embodiment, for example, the double flag DF may be a colored block with no numbers on it that covers the number on the first count wheel 2040 to provide clear visual feedback to the user that no doses remain in the inhalation device 100. The double flag DF is configured to cover the number on the first count wheel 2040 when no doses remain in the inhalation device 100.

[0159]

[0211] 20A-20M, the units or "tens" digits are circumferentially arranged in descending order in a first direction on the first count wheel 2040, and the "tens" digits are arranged in descending order in a second, opposite direction on the second count wheel 2036. While the counter subassembly described herein indicates the number of doses remaining in the inhalation device 100, those skilled in the art will appreciate that the counter assembly may be modified to indicate the number of doses delivered by the inhalation device by reversing the order of the count indicia arranged on the counting subassembly.

[0160]

[0212] 20C , the front or indicia display surface 2047 of the second count wheel 2036 overlaps or covers a portion of the front or indicia display surface 2041 of the first count wheel 2040. Thus, the "units" number on the first count wheel 2040 and the "tens" number on the second count wheel 2036 are not coplanar. In other words, the "units" number on the first count wheel 2040 and the "tens" number on the second count wheel 2036 are on different planes or levels, with the "tens" number elevated relative to the "units" number and disposed near the display window 2004.

[0161]

[0213] The structure and operation of the first count wheel 2040 and the second count wheel 2036 will now be described in more detail. The first count wheel 2040 is an annular or ring-shaped component having a front or indicia bearing face 2041 and an opposite back face containing a first counter gear 2048, as shown in Figures 20F, 20I, 20K, 20L, and 20M. The first counter gear 2048 may be integrally formed on or attached to the first count wheel 140. An outer periphery or portion 2043 extends between the front and back faces of the first count wheel 140. The outer periphery 2043 may be stepped, having a smaller diameter along the back face of the first count wheel 2040 and a larger diameter along the front face of the first count wheel 2040. Thus, the indicia bearing face 2041 of the first count wheel 2040 has a larger outer diameter than the first counter gear 2048.

[0162]

[0214] The front or indicia bearing face 2041 of the first count wheel 2040 includes a single tooth or protrusion 2042 extending radially outward from the outer periphery 2043. In another embodiment herein (not shown), the first count wheel 2040 may include more than a single tooth or protrusion 2042. Thus, while at least one single tooth or protrusion is required, and a single tooth is believed to be sufficient, preferably simplifying the design and reducing material costs of the first count wheel 2040, embodiments of the invention may include two or more teeth or protrusions.

[0163]

[0215] The second count wheel 2036 is an annular or ring-shaped component having a front or indicia-bearing face 2037 and an opposite back face, shown in FIG. 20I, which includes a second counter gear 2065. The second counter gear 2065 may be integrally formed on or attached to the second count wheel 2036. The second counter gear 2065 includes a plurality of gear teeth on its outer circumferential surface, with each gear tooth of the second counter gear 2065 extending radially outward. The second counter gear 2065 of the second count wheel 2036 is non-concentric with the count gear 2048 of the first count wheel 2040.

[0164]

[0216] 20C , 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 "ones" digit of the first count wheel 2040 is visible through the cutout 2069 in the second count wheel 2036. The geometry of the cutout 2069 is exemplary and includes one continuous slot disposed radially inward of the count indicia 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 indicia of the second count wheel 2036. A single tooth 2042 of the first count wheel 2040 engages with the second counter gear 2065 of the second count wheel 2036 once per rotation of the first count wheel 2040, causing the second count wheel 2036 to rotate intermittently. Stated another way, each time the first count wheel 2040 makes a complete rotation, the single tooth 2042 engages with the second counter gear 2065 of the second count wheel 2036, turning or rotating the second count wheel 2036 a fixed amount. Thus, there is a fixed rotation of the second count wheel 2036 once per rotation of the first count wheel 2040. The second count wheel 2036 rotates on a different axis of rotation than the first count wheel 2040. Stated another way, the first count wheel 2040 rotates about a first axis and the second count wheel 2036 rotates about a second axis that is parallel to and spaced apart from the first axis. Having the second count wheel 2036 on a different axis of rotation relative to the first count wheel 2040 allows the count markings on the second count wheel 2036 to be on a larger radius, which makes it easier to fit larger count markings thereon and improves readability.

[0165]

[0217] 20C , the spacing between the count markings on the second count wheel 2036 is greater than the spacing between the count markings on the first count wheel 2040. The increased spacing between the count markings on the second count wheel 2036 reduces the risk of a user seeing adjacent markings on the second count wheel 2036 through the viewing window 2004. Furthermore, because the second count wheel 2036 overlaps or covers a portion of the first count wheel 2040, the second count wheel 2036 covers adjacent markings on the first count wheel 2040, reducing the risk of a user seeing adjacent markings on the first count wheel 2040 through the viewing window 2004. Reducing the visibility of adjacent count markings on the count wheels allows for greater flexibility in the shape of the viewing window 104. For example, as shown in the embodiment of Figures 20A-20M, the display window 2004 of the inhaler device is circular rather than rectangular, which may improve visibility of the count markings when the inhaler device is viewed from above or below the display window, i.e., at an angle that is not perpendicular to the front of the inhaler device.

[0166]

[0218] The arrangement of the components of the counter subassembly 2034 potentially reduces the overall lateral space occupied by the counter subassembly 2034 compared to the counter subassembly 134 described above. There may be limitations on the space available for the dose counter mechanism and this embodiment provides a space-efficient arrangement of the components of the counter subassembly. In particular, 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 to each other compared to the counter subassembly 134 described above, thus reducing the overall width of the counter subassembly and / or maximizing the size of the count wheels (and therefore the count indicia) within the available width or space of the counter subassembly.

[0167]

[0219] The counter subassembly 2034 also does not require any type of intermediate component between the count wheels. Driving the second count wheel 2036 directly from the first count wheel 2040 simplifies the counter subassembly 2034, minimizing the overall component count of the inhalation device 100 and reducing the overall cost and complexity of the inhalation device 100. Furthermore, the elimination of intermediate components between the count wheels means that there is a shorter tolerance chain for alignment between the first count wheel 2040 and the second count wheel 2036, which results in more consistent alignment between the first and second digits of a two-digit number on the display.

[0168]

[0220] Referring to FIGS. 20D and 20E, a lens 2071 may be positioned in front of the count indicia within the area of ​​the viewing window 2004. The lens 2071 can improve the visibility of the count indicia when the inhaler device is viewed from above or below the viewing window, i.e., at an angle other than perpendicular to the front of the inhaler device. The depth of the lens 2071 is maximized to reduce the perceived distance between the front of the inhaler housing and the front of the count wheel. Additionally, as shown in FIG. 20E, the lens 2071 may be non-planar to reduce the visibility of the area surrounding the window. In one embodiment, the peripheral edge of the lens 2071 can be frosted to reduce the visibility of the area of ​​the viewing window 2004 away from the target count indicia. In one embodiment, the lens 2071 can also incorporate magnification to maximize the perceived height of the count indicia.

[0169]

[0221] 20F-20H, in this embodiment, first count wheel 2040 is driven by first bottom sheet take-up gear 128A of dispensing subassembly 120 rather than second bottom sheet take-up gear 128B. More specifically, in this embodiment, as best shown in FIG. 20F, transmission gear 2044 is attached to the opposite end of first spindle 129A of first bottom sheet take-up gear 128A so that transmission gear 2044, first spindle 129A, and first bottom sheet take-up gear 128A rotate simultaneously as an assembly. This causes transmission gear 2044 to rotate in a first direction together with first bottom sheet take-up gear 128A when mouthpiece cover 108 is opened. Transmission gear 2044 meshes with or directly drives first counter gear 2048 to rotate it in a second, opposite direction. Thus, in this embodiment, when the mouthpiece cover 108 is opened, the rotation of the transfer gear 2044 and first count wheel 2040 in a second, opposite direction causes the first counter gear 2048 to rotate in the opposite direction. As with the previous embodiment, the first count wheel 2040 rotates a fixed angle each time a dose is dispensed.

[0170]

[0222] As best shown in FIG. 20I, the first count wheel 2040 directly drives the second count wheel 2036 through interaction between a single tooth 2042 and the second counter gear 2065 such that the second count wheel 2036 rotates in the opposite direction to the first count wheel 2040. This causes the first count wheel 2040 to rotate in the second opposite direction (i.e., counterclockwise) and the second count wheel 2036 to rotate in the first direction (i.e., clockwise). The second count wheel 2036 is stationary and does not rotate when the single tooth 2042 of the first count wheel 2040 is not engaged with the second counter gear 2065 of the second count wheel 2036. More specifically, in this embodiment, a second flexible arm 2093 is integrally formed on or attached to the backplate 2073 and is configured to interact with a second counter gear 2065 disposed on the back surface of the second count wheel 2036. The second flexible arm 2093 is configured to interact with and maintain the position of the second count component 2036 when the second count component 2036 is not engaged with the first count wheel 2040. Stated another way, the second flexible arm 2093 keeps or holds the second count wheel 2036 aligned when it is not being driven by the first count wheel 2040. In this manner, the second flexible arm 2093 reduces variations in the position of the count indicia on the second count wheel 2036 that may be due to component tolerances. The second flexible arm 2093 includes a detent 2061 thereon that is configured to extend between adjacent gear teeth of the second counter gear 2065 of the second counting component 2036. The second flexible arm 2093 ensures that the second counting component 2036 cannot move away from its currently indexed position until it is driven by the first count wheel 2040 with sufficient force to deflect the second flexible arm 2093.The second flexible arm 2093 also helps to maintain a consistent position of the second counting component 2036 relative to the display window 2004 of the inhalation device, resulting in more consistent alignment between the first and second digits of the two-digit number on the display.

[0171]

[0223] In this embodiment, a detent feature is also added to counter subassembly 2034 to ensure the rotational accuracy with which counter subassembly 2034 is driven when mouthpiece cover 108 is opened. The detent feature is configured to drive first count wheel 2040 to its final position when driven by dispensing subassembly 120 within a certain number of rotations of first count wheel 2040's target nominal orientation, but the detent feature does not have enough force to rotate the entire gear train leading to first count wheel 2040 with it (i.e., the gear train of dispensing subassembly 120). The detent feature accommodates tolerance variations in the gear train of dispensing subassembly 120.

[0172]

[0224] 20I-20M, the detent feature is integrally formed on or attached to the backplate 2073 and includes a first flexible arm 2077 configured to interact with a detent wheel 2079 disposed on the backside of the first count wheel 2040. The detent wheel 2079 may be concentric with the first counter gear 2048. The detent wheel 2079 includes a plurality of radially extending rounded protrusions 2081, with a notch or gap 2083 formed between each pair of adjacent rounded protrusions 2081. The first flexible arm 2077 includes a detent 2085 configured to be received within the notch 2083 of the detent wheel 2079.

[0173]

[0225] First flexible arm 2077 is configured to pull or rotate first count wheel 2040, thereby controlling the position of first count wheel 2040. With particular reference to FIG. 20L , the rotation of first count wheel 2040 is driven by mouthpiece cover 108 and dispensing subassembly 120 to a target nominal position Θ°, after which the rotation of first count wheel 2040 is driven by first flexible arm 2077. More specifically, when mouthpiece cover 108 is opened and first count wheel 2040 reaches Θ° before the final position, transmission gear 2044 rotates in a first direction (i.e., clockwise) together with first bottom sheet take-up gear 128A, as described above, thereby rotating first count wheel 2040 in a second, opposite direction (i.e., counterclockwise). After the first count wheel 2040 reaches the target nominal position, i.e., Θ°, the first flexible arm 2077 further rotates the first count wheel 2040 in a second, opposite direction (i.e., counterclockwise) because the first flexible arm 2077 is biased such that the detents 2085 of the first flexible arm 2077 are received within the notches 2083 of the detent wheel 2079. As shown in FIG. 20M, as the detents 2085 of the first flexible arm 2077 move into the notches 2083 of the detent wheel 2079, the first flexible arm 2077 pulls the first count wheel 2040 in the second direction (i.e., counterclockwise) to a final position, thereby driving the transfer gear 2044 in the first direction (i.e., clockwise) prior to or before the rotation of the first bottom sheet take-up gear 128A. Thus, first flexible arm 2077 drives and fixes first count wheel 2040 precisely to the target position, independent of the tolerance chain of mouthpiece cover 108 and dispensing subassembly 120 leading to it.

[0174]

[0226] For the detent feature to operate properly, the inhalation device must include a suitably large clearance or backlash that allows the counter subassembly 2034 to rotate forward, i.e., in the second, opposite direction, without the gear train of the dispensing subassembly 120. In the embodiment of FIGS. 20A-20M, a suitable backlash or clearance is provided at the interface between the first bottom sheet take-up gear 128A and the transfer gear 2044. As discussed above with reference to FIGS. 20F-20H, the transfer gear 2044 is attached to the opposite end of the first spindle 129A of the first bottom sheet take-up gear 128A. More specifically, the first spindle 129A includes a pair of uprights or posts 2087 having free or unattached ends 2089. The free or unattached ends 2089 of the posts 2087 abut a relatively large aperture 2091 in the transfer gear 2044. The loose fit between the post 2087 and the aperture 2091 provides suitable backlash or clearance for the detent feature to operate properly. More specifically, as the transfer gear 2044 rotates in a first direction (i.e., clockwise) along with the first bottom sheet take-up gear 128A, the post 2087 of the first bottom sheet take-up gear 128A contacts the transfer gear 2044 at the drive surface 2091A of the aperture 2091. Conversely, when the first flexible arm 2077 pulls the first count wheel 2040 in the second direction (i.e., counterclockwise) to its final position, thereby driving the transmission gear 2044 in the first direction (i.e., clockwise) prior to or before the rotation of the first bottom sheet winding gear 128A, there is sufficient clearance within the aperture 2091 of the transmission gear 2044 to allow the free or unattached end 2089 of the support 2087 to move toward the non-drive surface 2091B of the aperture 2091.

[0175]

[0227] While the detent feature including the first flexible arm 2077 is depicted only in the embodiment of Figures 20A-20M, it will be apparent to one skilled in the art that this detent feature may be incorporated into the counter subassemblies 134, 1534, 1634, 1734 and / or 1834 to ensure rotational accuracy of the respective first count wheels.

[0176]

[0228] While various embodiments according to the present invention have been described above, it should be understood that they have been presented by way of illustration and example only, and not by way of limitation. It will be apparent to those skilled in the art that various changes in form and detail can be made therein without departing from the spirit and scope of the invention. Accordingly, the breadth and scope of the present invention should not be limited by any of the exemplary embodiments described above, but should be defined only in accordance with the appended claims and their equivalents. It will also be understood that each feature of each embodiment discussed herein and each reference cited herein can be used in combination with the features of any other embodiment. All patents and publications discussed herein are incorporated herein by reference in their entirety.

Claims

1. 1. A dry powder inhaler device comprising: an actuator for operating a dispensing mechanism of the dry powder inhaler; a first count wheel configured to be rotated by the dispensing mechanism, the first count wheel including a single tooth extending radially outward from an outer periphery or portion of the first count wheel; a second count component disposed adjacent the outer circumferential surface or portion of the first count wheel, the second count component including a plurality of notches on the outer surface or portion of the second count component, each notch extending radially inward and each notch configured to mate with a single tooth; Equipped with the single tooth of the first count wheel engages one of the plurality of notches of the second count component once per rotation of the first count wheel to intermittently rotate the second count component, and the first count wheel and the second count component are configured to rotate in opposite directions; A dry powder inhaler, wherein the first count wheel and the second counting component collectively indicate the number of doses remaining in the inhaler or the number of doses delivered by the inhaler.

2. 10. The dry powder inhaler of claim 1, wherein the actuator is a mouthpiece cover.

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

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

5. 2. The dry powder inhaler of claim 1, wherein a segment of the outer surface or outer portion of the second counting component extending between two adjacent notches of the plurality of notches is concave and forms an arcuate depression that matches the outer circumferential surface or outer portion of the first counting wheel.

6. 2. The dry powder inhaler of claim 1, wherein the outer surface or outer portion of the second counting component includes a plurality of segments, each segment extending between two adjacent notches of the plurality of notches, and each segment being concave and forming an arc-shaped depression that matches the outer circumferential surface or outer portion of the first counting wheel.

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

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

9. 2. The dry powder inhaler of claim 1, wherein the marking surface of the first count wheel has numbers in the "units" digit and the marking surface of the second counting component has numbers in the "tens" digit.

10. 10. The dry powder inhaler of claim 9, wherein the marking bearing surface of the first count wheel and the marking bearing surface of the second count component are coplanar.

11. 10. The dry powder inhaler of claim 9, wherein the marking display surface of the first count wheel and the marking display surface of the second counting component are not coplanar, and the marking display surface of the second counting component is disposed closer to the display window of the inhaler than the marking display surface of the first count wheel.

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

13. 2. The dry powder inhaler of claim 1, wherein the second count component includes a single flag instead of a zero, the single flag being a colored block with no number on it.

14. 2. The dry powder inhaler of claim 1, wherein the second counting component includes a double flag, the double flag being a colored block with no numbers thereon, the double flag configured to cover the numbers on the first count wheel when no doses remain in the inhaler.

15. 2. The dry powder inhaler of claim 1, wherein the outer periphery or portion of the first count wheel is generally circular with a clearance gap around the single tooth.

16. 2. The dry powder inhaler of claim 1, wherein the second counting component is stationary when the single tooth of the first counting wheel is not engaged within one of the plurality of notches of the second counting component.

17. 2. The dry powder inhaler of claim 1, wherein the first count wheel includes a detent wheel having a plurality of notches, and the dry powder inhaler further includes a housing and a flexible arm extending from the housing, the flexible arm including a detent thereon, the detent configured to be received within a notch of the plurality of notches of the first count wheel.

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

19. 2. The dry powder inhaler of claim 1, further comprising a housing and a flexible arm extending from the housing, the flexible arm including a detent thereon, the detent configured to be received within a notch of the plurality of notches of the second counting component.

20. 1. A dry powder inhaler device comprising: an actuator for operating a dispensing mechanism of the dry powder inhaler; a first count wheel configured to be rotated by the dispensing mechanism, the first count wheel including a single tooth extending radially outward from a circumferential surface or side of the first count wheel; a second counting component disposed adjacent to the first counting wheel, the second counting component including a plurality of rack teeth on an outer surface or portion thereof, the plurality of rack teeth being aligned longitudinally and extending outwardly in a direction toward the single tooth of the first counting wheel; Equipped with the single tooth of the first count wheel engages one of the plurality of rack teeth of the second count component once per complete revolution of the first count wheel to intermittently translate the second count component; A dry powder inhaler, wherein the first count wheel and the second counting component collectively indicate the number of doses remaining in the inhaler or the number of doses delivered by the inhaler.

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

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

23. 21. The dry powder inhaler of claim 20, wherein the first count wheel rotates about a first axis of the first count wheel and the second count component translates axially along a longitudinal axis of the inhaler.

24. 21. The dry powder inhaler of claim 20, wherein the longitudinal axis of the inhaler is laterally spaced from the first axis.

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

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

27. 21. The dry powder inhaler of claim 20, wherein the marking surface of the first count wheel has "ones" numbers arranged thereon, and the marking surface of the second counting component has "tens" numbers arranged thereon.

28. 28. The dry powder inhaler of claim 27, wherein the marking display surface of the first count wheel and the marking display surface of the second counting component are not coplanar, and the marking display surface of the second counting component is disposed closer to the display window of the inhaler than the marking display surface of the first count wheel.

29. 21. The dry powder inhaler of claim 20, wherein the second counting component includes a single flag instead of a number zero, the single flag being a colored block with no number on it.

30. 21. The dry powder inhaler of claim 20, wherein the second counting component includes a double flag, the double flag being a colored block with no numbers thereon, the double flag configured to cover the units digit of the first count wheel when no doses remain in the inhaler.

31. 21. The dry powder inhaler of claim 20, wherein the second counting component is stationary when the single tooth is not engaged within one of the plurality of rack teeth.

32. 32. The dry powder inhaler of claim 31, wherein the second counting component includes a plurality of notches.

33. 33. The dry powder inhaler of claim 32, wherein the first count wheel and the second counting component are disposed within a housing of the dry powder inhaler, the housing including a flexible arm extending from an inner surface of the housing, the flexible arm including a detent thereon, the detent configured to be received within a notch among the plurality of notches of the second counting component.

34. 34. The dry powder inhaler of claim 33, wherein the outer surface or outer portion of the second counting component including the plurality of rack teeth is a first outer surface or outer portion, and the plurality of notches are disposed on a second outer surface or outer portion opposite the first outer surface or outer portion.

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

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

37. 1. A dry powder inhaler device comprising: an actuator for operating a dispensing mechanism of the dry powder inhaler; a first count wheel configured to be rotated by the dispensing mechanism, the first count wheel including a single tooth extending radially inward from an inner periphery or portion of the first count wheel; a second count component disposed at least partially within the first count wheel, the second count component including a plurality of gear teeth on an outer circumferential surface or portion thereof, each gear tooth extending radially outward, the second count component being non-concentric with the first count wheel; Equipped with the single tooth of the first count wheel indirectly or directly engages one of the plurality of gear teeth of the second count component once per rotation of the first count wheel to intermittently rotate the second count component; A dry powder inhaler, wherein the first count wheel and the second counting component collectively indicate the number of doses remaining in the inhaler or the number of doses delivered by the inhaler.

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

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

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

41. 38. The dry powder inhaler of claim 37, wherein the marking surface of the first count wheel has "ones" numbers arranged thereon, and the marking surface of the second counting component has "tens" numbers arranged thereon.

42. 42. The dry powder inhaler of claim 41, wherein the marking display surface of the first count wheel and the marking display surface of the second counting component are not coplanar, and the marking display surface of the second counting component is disposed closer to the display window of the inhaler than the marking display surface of the first count wheel.

43. 38. The dry powder inhaler of claim 37, wherein the second count component includes a single flag instead of a number zero, the single flag being a colored block with no number on it.

44. 38. The dry powder inhaler of claim 37, wherein the second counting component includes a double flag, the double flag being a colored block with no numbers thereon, the double flag configured to cover the units digit of the first count wheel when no doses remain in the inhaler.

45. 38. The dry powder inhaler of claim 37, wherein the second counting component is stationary when the single tooth is not engaged with one of the plurality of gear teeth of the second counting component.

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

47. an intermediate gear disposed between the inner circumferential surface or inner portion of the first count wheel and the outer circumferential surface or outer portion of the second count component; 38. The dry powder inhaler of claim 37, wherein the single tooth of the first count wheel directly engages the intermediate gear, the intermediate gear directly engages the plurality of gear teeth of the second counting component, and the first count wheel and the second counting component are configured to rotate in opposite directions to each other.

Images