Tensioning mechanism for detracting sheet from blister blade strip suitable

Abstract

An inhaler device for delivering a dry powder medicament from at least one blister band. The inhaler device includes an actuator for operating a dispensing mechanism of the inhaler device. A tensioning mechanism for use in an inhaler device is configured to maintain consistent tension in a blister band during the service life of the device.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of U.S. Provisional Patent Application No. 63 / 483,383, filed February 6, 2023, which is incorporated herein by reference in its entirety. Technical Field

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

[0003] A dry powder dispenser device can be used to deliver medication to a patient for inhalation. Such devices are commonly used to treat and prevent respiratory diseases, including but not limited to asthma and chronic obstructive pulmonary disease (COPD). The drug carrier may include a blister strip containing multiple individual doses of powdered medication. Such devices typically include a mechanism, such as a puncture device, for accessing a medication dose by opening one or more blister cavities. The user can then access the powdered medication through the device and inhale it.

[0004] In order for an inhalation-type device or inhaler device of the type described above to function properly, it is necessary to maintain consistent tension in the blister strip throughout the useful life of the device.Embodiments of the present invention relate to mechanisms for maintaining consistent tension in a blister strip in a dry powder inhaler device. Summary of the Invention

[0005] According to a first embodiment of the present invention, a tensioning mechanism for peeling a sheet from a blister strip suitable for a dry powder inhaler device is provided. The tensioning mechanism includes a base, a nut (the nut includes at least one rib that engages with a cam surface), a compression spring (the compression spring is adjacent to the nut in the longitudinal axial direction), and a winding hub disposed around the nut and the compression spring. The nut is disposed between the winding hub and the base and is connected to each winding hub and the base. The winding hub is rotationally constrained by the nut and is configured to rotate relative to the base. When the base is driven to rotate, the nut is configured to interact with the compression spring and the cam surface to apply torque to the winding hub. When the winding hub applies an opposing torque to the nut, the nut moves along the cam surface and compresses the compression spring in the axial direction.

[0006] In one aspect of a first embodiment, which may be combined with any other aspect herein, the present disclosure provides a take-up hub including a hook portion disposed on an outer surface thereof. The hook portion is configured to connect to an end of a sheet of blister strip such that rotation of the take-up hub causes the sheet of blister strip to wrap around the take-up hub.

[0007] In one aspect of the first embodiment, and in combination with any other aspect herein, the present disclosure provides that the take-up hub is axially constrained relative to the base.

[0008] In one aspect of the first embodiment, and in combination with any other aspect herein, the present disclosure provides that the take-up hub is axially restrained relative to the base by a bayonet connection between the base and the take-up hub.

[0009] In one aspect of a first embodiment, and in combination with any other aspect herein, the present disclosure provides a bayonet connection comprising a radial extension on a base and an internal flange in a take-up hub, the internal flange comprising an axial slot configured to allow the radial extension to pass therethrough.

[0010] In one aspect of a first embodiment, and in combination with any other aspect herein, the present disclosure provides a base including a plurality of gear teeth integrally formed with or fixed to an outer circumferential surface of the base.

[0011] In one aspect of the first embodiment, and in combination with any other aspect herein, the present disclosure provides that the cam surface includes alternating vertical surface portions and inclined surface portions.

[0012] In one aspect of the first embodiment, and in combination with any other aspect herein, the present disclosure provides that the at least one rib includes a plurality of ribs arranged in a circumferentially spaced relationship.

[0013] In one aspect of the first embodiment, which may be combined with any other aspect herein, the present disclosure provides that the cam surface is integrally formed with or fixed to a portion of the base, at least one rib protrudes radially inward from an inner circumferential surface of the nut, and the takeup hub is rotationally locked to the nut.

[0014] In one aspect of the first embodiment, and in combination with any other aspect herein, the present invention provides for a compression spring to extend between the takeup hub and the nut.

[0015] In one aspect of the first embodiment, and in combination with any other aspect herein, the present invention provides that the take-up hub is rotationally locked to the nut by an outwardly extending rib, which projects radially outward from the outer circumferential surface of the nut and is received in an axial groove of the take-up hub.

[0016] In one aspect of the first embodiment, and combinable with any other aspect herein, the present disclosure provides that the cam surface has a first outer diameter and the compression spring has a second outer diameter, the first outer diameter being greater than the second outer diameter.

[0017] In one aspect of a first embodiment, which may be combined with any other aspect herein, the present disclosure provides that the cam surface is integrally formed with or fixed to a portion of the take-up hub, at least one rib protrudes radially outward from an outer circumferential surface of the nut, and the base is rotationally locked to the nut.

[0018] In one aspect of a first embodiment, which may be combined with any other aspect herein, the present disclosure provides a shaft extending from a base, the shaft being integrally formed with the base or fixed thereto. The base is rotationally locked to the nut by an inwardly extending rib that projects radially inward from an inner circumferential surface of the nut and is received within an axial groove of the shaft.

[0019] In one aspect of the first embodiment, and in combination with any other aspect herein, the present disclosure provides for a compression spring to extend between the nut and the base.

[0020] According to a second embodiment of the present invention, a dry powder inhaler (DPI) is provided, comprising a housing, a positioning reel, a winding hub, and a tensioning mechanism. The housing accommodates at least one blister strip suitable for the DPI device, the blister strip comprising a bottom sheet and a top sheet releasably secured to the bottom sheet. The positioning reel is rotationally driven in a first direction, with the outer surface of the positioning reel receiving the bottom sheet of the blister strip. The winding hub is rotationally driven in a first direction or a second, opposite direction, with the outer surface of the winding hub attached to the end of the top sheet, and rotation of the winding hub causes the top sheet to be wound around the outer surface of the winding hub. The tensioning mechanism comprises a slide and at least one spring attached to the slide. The tensioning mechanism is coupled to the housing so as to allow the slide to move axially relative to the housing along a predetermined path. The slide is configured to receive the middle portion of the top sheet of the blister strip, the middle portion of the top sheet being disposed between the positioning reel and the winding hub. Increased tension along the top sheet of the blister strip causes the slider to move axially along a predetermined path. The axial movement of the slider axially compresses or stretches the spring to reduce the tension along the top sheet of the blister strip.

[0021] In one aspect of the second embodiment, and combinable with any other aspect herein, the present disclosure provides that a first end of the spring is attached to the slider, and a second end of the spring is attached to the housing.

[0022] In one aspect of the second embodiment, and in combination with any other aspect herein, the present disclosure provides that the predetermined path is formed by a groove in an inner surface of the housing.

[0023] In one aspect of the second embodiment, and in combination with any other aspect herein, the present disclosure provides that the spring is a compression spring, and the compression spring is biased to urge the slide away from each of the positioning spool and the take-up hub.

[0024] In one aspect of the second embodiment, and in combination with any other aspect herein, the present invention provides that axial compression of the compression spring moves the slide closer to each of the positioning spool and the take-up hub.

[0025] In one aspect of the second embodiment, and in combination with any other aspect herein, the present disclosure provides that the predetermined path is a linear predetermined path.

[0026] In an aspect of a second embodiment, and in combination with any other aspect herein, the present disclosure provides that the at least one spring comprises a single spring.

[0027] In an aspect of a second embodiment, and in combination with any other aspect herein, the present disclosure provides that the at least one spring includes two springs.

[0028] In one aspect of the second embodiment, and in combination with any other aspect herein, the present disclosure provides that the take-up hub is rotationally driven in a first direction.

[0029] In one aspect of the second embodiment, and in combination with any other aspect herein, the present disclosure provides that the take-up hub is rotationally driven in a second, opposite direction.

[0030] In one aspect of the second embodiment, and combinable with any other aspect herein, the present disclosure provides that at least one spring is a compression spring, and axial movement of the slider axially compresses the spring to reduce tension along the top sheet of the blister strip.

[0031] In one aspect of the second embodiment, and combinable with any other aspect herein, the present disclosure provides that at least one spring is a tension spring, and axial movement of the slider axially tensions the spring to reduce tension along the top sheet of the blister strip.

[0032] According to a third embodiment of the present invention, a dry powder inhaler (DPI) is provided, comprising a housing, a positioning reel, a winding hub, and a tensioning mechanism. The housing houses at least one blister strip suitable for use with the DPI device, the blister strip comprising a bottom sheet and a top sheet releasably secured to the bottom sheet. The housing comprises a curved groove on its inner surface and a pin extending radially from the inner surface of the housing, the pin being disposed near a first end of the curved groove and secured to the housing. The positioning reel is rotationally driven in a first direction, and an outer surface of the positioning reel receives the bottom sheet of the blister strip. The winding hub is rotationally driven in a second, opposite direction. The outer surface of the winding hub is connected to an end of the top sheet, and rotation of the winding hub causes the top sheet to wind around the outer surface of the winding hub. The winding hub is coupled to the housing to allow the winding hub to move relative to the housing along the curved groove. The tensioning mechanism comprises at least one spring coupled to the winding hub. A first end of the spring is secured to the housing, and a second end of the spring is coupled to the winding hub. The pin is configured to receive a middle portion of the top sheet of the blister strip, the middle portion of the top sheet extending between the positioning reel and the take-up hub. Increased tension along the top sheet of the blister strip causes the take-up hub to move along the curved slot of the housing. Movement of the take-up hub deforms the spring in an axial direction to reduce tension along the top sheet of the blister strip.

[0033] In an aspect of the third embodiment, and in combination with any other aspect herein, the present disclosure provides that at least one spring is a tension spring.

[0034] In one aspect of a third embodiment, and in combination with any other aspect herein, the present invention provides a tensioning mechanism comprising a bracket having a first end, a second end, and a middle portion, the first end being coupled to allow relative rotation of the positioning reel relative to the bracket, the second end being attached to the second end of the spring, and the middle portion being coupled to the winding hub to allow relative rotation of the winding hub relative to the bracket.

[0035] In one aspect of the third embodiment, and in combination with any other aspect herein, the present disclosure provides that the bracket is rotatable relative to the housing.

[0036] In one aspect of a third embodiment, which may be combined with any other aspect herein, the present disclosure provides that a tension spring is biased to position a take-up hub at a second end of the curved slot, the second end being opposite the curved slot and the first end of the pin. Movement of the take-up hub toward the pin axially extends the tension spring to reduce tension along the top sheet of the blister strip.

[0037] In one aspect of the third embodiment, and in combination with any other aspect herein, the present disclosure provides that the tension spring is arranged aligned with a centerline of the top sheet.

[0038] In one aspect of the third embodiment, and in combination with any other aspect herein, the present disclosure provides that the curved slot is concentric with the axis of rotation of the positioning reel.

[0039] In an aspect of the third embodiment, and in combination with any other aspect herein, the present disclosure provides that at least one spring is a torsion spring.

[0040] In one aspect of a third embodiment, and in combination with any other aspect herein, the present disclosure provides at least one spring including a first torsion spring and a second torsion spring, the first torsion spring being configured to act on a first side of the take-up hub and the second torsion spring being configured to act on a second, opposite side of the take-up hub.

[0041] In one aspect of the third embodiment, and in combination with any other aspects herein, the present disclosure provides a first leg of the torsion spring fixed to an inner surface of the housing, and a second leg of the torsion spring coupled to the take-up hub for movement along the curved slot with the take-up hub.

[0042] In one aspect of the third embodiment, and in combination with any other aspect herein, the present disclosure provides that the body of the torsion spring is arranged concentrically with the axis of rotation of the positioning spool.

[0043] In one aspect of a third embodiment, and in combination with any other aspect herein, the present disclosure provides that a torsion spring is biased to position the take-up hub at a second end of the curved slot, opposite the first end of the curved slot and the pin, and movement of the take-up hub in a direction toward the pin twists the torsion spring to reduce tension along the top sheet of the blister strip. BRIEF DESCRIPTION OF THE DRAWINGS

[0044] The above features and other advantages of the present invention will be apparent from the following description of the embodiments of the present invention in conjunction with the accompanying drawings. The accompanying drawings are incorporated herein as a part of this specification and are provided to further illustrate the principles of the present invention and to enable those skilled in the art to make and use the present invention. These drawings are not drawn to scale.

[0045] Figure 1A is a front view of an inhaler device according to an embodiment of the present invention, wherein the mouthpiece cover of the inhaler device is in a closed position.

[0046] Figure 1B yes Figure 1A A rear view of an inhaler device of FIG. 1 , wherein the mouthpiece cover of the inhaler device is in a closed position.

[0047] Figure 1C yes Figure 1A A front view of an inhaler device of FIG. 1 , wherein the mouthpiece cover of the inhaler device is in an open position.

[0048] Figure 1D Is a curve graph used to show Figure 1A-Figure 1C The approximate actuation force profile of an inhaler device and mouthpiece cover is shown (dashed line) and compared with the approximate actuation force profile of an inhaler device in which the dispensing mechanism is not actuated during the initial phase of mouthpiece cover travel (solid line).

[0049] Figure 2 is used for Figure 1A A perspective view of two blister strips within an inhaler device.

[0050] Figure 3A yes Figure 1A , with the mouthpiece cover of the inhaler device in an open position and the housing of the inhaler device removed for illustrative purposes only.

[0051] Figure 3B yes Figure 1A A cross-sectional perspective view of a portion of an inhaler device showing a portion of an inhaler device Figure 1A part of the airflow path of an inhaler device.

[0052] Figure 4 yes Figure 1A A perspective view of a manifold of an inhaler device of FIG. 1 , wherein the manifold is removed from the inhaler device for illustration purposes only.

[0053] Figure 4A It is along Figure 4 A cross-sectional view taken along line AA.

[0054] Figure 5 yes Figure 4 A perspective view of the manifold located at Figure 1A near the air inlet of the housing of the inhaler device.

[0055] Figure 6 yes Figure 1A Another perspective view of a manifold of an inhaler device of FIG, wherein the manifold is removed from the inhaler device for illustration purposes only.

[0056] Figure 7 is a schematic diagram showing the Figure 1A The airflow path of the manifold of the inhaler device.

[0057] Figure 8 is a schematic flow chart showing the Figure 1A The airflow path of the manifold of an inhaler device.

[0058] Figure 9A yes Figure 1A, with the mouthpiece cover of the inhaler device in an open position and with a portion of the housing of the inhaler device removed for illustrative purposes only.

[0059] Figure 9B yes Figure 1A , with the mouthpiece cover and housing of the inhaler device removed for illustration purposes only.

[0060] Figure 10 yes Figure 1A 2. A front view of a ratchet mechanism of an inhaler device of FIG. 1, wherein the ratchet gear is removed from the inhaler device for illustration purposes only.

[0061] Figure 10A Shown with the mouthpiece cover in the closed position Figure 10 ratchet mechanism.

[0062] Figure 10B Shown with the mouthpiece cover in the open position Figure 10 ratchet mechanism.

[0063] Figure 11 yes Figure 1A A perspective view of a portion of a mouthpiece cover and dispensing subassembly of an inhaler device of FIG. 1 , wherein the mouthpiece cover and dispensing subassembly are removed from the inhaler device for illustration purposes only.

[0064] Figure 12A yes Figure 1A 1 , wherein the counter subassembly is removed from the inhaler device for illustration purposes only.

[0065] Figure 12B yes Figure 12A Front view of the counter subassembly.

[0066] Figure 12C It is along Figure 12B The line CC intercepts Figure 12A Cross-sectional view of the counter subassembly.

[0067] Figure 12D It is along Figure 12C The line DD intercepts Figure 12A Cross-sectional view of the counter subassembly.

[0068] Figure 13A yes Figure 1A Schematic diagram of a tensioning mechanism of an inhaler device of FIG. 1 , wherein the tensioning mechanism is shown at an early stage in the useful life of the device.

[0069] Figure 13B yes Figure 1ASchematic diagram of a tensioning mechanism of an inhaler device, wherein the tensioning mechanism is shown nearing the end of the useful life of the device.

[0070] Figure 14A yes Figure 1A A perspective view of a tensioning mechanism of an inhaler device of FIG. 1 , wherein the tensioning mechanism is removed from the inhaler device for illustration purposes only.

[0071] Figure 14B yes Figure 14A Cross-sectional view of the tensioning mechanism.

[0072] Figure 14C yes Figure 14A Cross-sectional view of the tensioning mechanism.

[0073] Figure 14D yes Figure 14A Exploded perspective view of the base and nut of the tensioning mechanism.

[0074] Figure 14E yes Figure 14A A series of cross-sectional views of the tensioning mechanism of FIG. 1 , illustrating the movement of the nut during operation of the inhaler device.

[0075] Figure 15A According to another embodiment of the present invention, Figure 1A sectional view of a tensioning mechanism in an inhaler device of , wherein the tensioning mechanism is removed from the inhaler device for illustrative purposes only.

[0076] Figure 15B yes Figure 15A A perspective view of a tensioning mechanism with the hub of the tensioning mechanism removed for illustration purposes.

[0077] Figure 16A According to another embodiment of the present invention, Figure 1A sectional view of a tensioning mechanism in an inhaler device of , wherein the tensioning mechanism is removed from the inhaler device for illustrative purposes only.

[0078] Figure 16B yes Figure 16A A perspective view of a tensioning mechanism of FIG, wherein the hub of the tensioning mechanism is removed for illustration purposes only.

[0079] Figure 17A According to another embodiment of the present invention, Figure 1A sectional view of a tensioning mechanism in an inhaler device of , wherein the tensioning mechanism is removed from the inhaler device for illustrative purposes only.

[0080] Figure 17B yes Figure 17A A perspective view of a tensioning mechanism of FIG, wherein the hub of the tensioning mechanism is removed for illustration purposes only.

[0081] Figure 18 According to another embodiment of the present invention, Figure 1A 1 , wherein the tensioning mechanism is removed from the inhaler device for illustration purposes only.

[0082] Figure 19A yes Figure 18 A side view of a tensioning mechanism, wherein the tensioning mechanism is in a first position.

[0083] Figure 19B yes Figure 18 A side view of the tensioning mechanism, wherein the tensioning mechanism is in a second position.

[0084] Figure 20 yes Figure 18 A graph showing the performance characteristics of the tensioning mechanism.

[0085] Figure 21 According to another embodiment of the present invention, Figure 1A 1 , wherein the tensioning mechanism is removed from the inhaler device for illustration purposes only.

[0086] Figure 22 yes Figure 21 Side view of the tensioning mechanism.

[0087] Figure 23A yes Figure 21 A side view of a tensioning mechanism, wherein the tensioning mechanism is in a first position.

[0088] Figure 23B yes Figure 21 A side view of the tensioning mechanism, wherein the tensioning mechanism is in a second position.

[0089] Figure 24 According to another embodiment of the present invention, Figure 1A 1 , wherein the tensioning mechanism is removed from the inhaler device for illustration purposes only.

[0090] Figure 25 yes Figure 24 Relative side view of the tensioning mechanism.

[0091] Figure 26A According to another embodiment of the present invention, Figure 1A 1 , wherein the tensioning mechanism is removed from the inhaler device for illustration purposes only.

[0092] Figure 26B yes Figure 26A1 , wherein the hub is removed from the inhaler device for illustration purposes only.

[0093] Figure 26C yes Figure 26A A top view of the tensioning mechanism of FIG. 1 with its bayonet connection in an open or unlocked state.

[0094] Figure 26CC yes Figure 26C sectional view of .

[0095] Figure 26D yes Figure 26A Top view of the tensioning mechanism of FIG. 1 , with its bayonet connection in the closed or locked state.

[0096] Figure 26DD yes Figure 26D sectional view of .

[0097] Figure 26E yes Figure 26A A perspective view of a nut of a tensioning mechanism of an inhaler device, wherein the nut is removed from the inhaler device for illustration purposes only.

[0098] Figure 26F yes Figure 26A Another perspective view of the hub of the tensioning mechanism of FIG. 1 , wherein the hub is removed from the inhaler device for illustration purposes only.

[0099] Figure 26G is configured with Figure 26A A perspective view of a nested fixture used in conjunction with a tensioning mechanism.

[0100] Figure 26H yes Figure 26A A perspective view of a base of a tensioning mechanism of FIG. 1 , wherein the base is removed from the inhaler device for illustration purposes only.

[0101] Figure 26I Is set in Figure 26F Nested fixtures on Figure 26H Perspective view of the base.

[0102] Figure 26J Is set in Figure 26F Nested fixtures on Figure 26H FIG. 1 is a perspective view of a base showing a state in which the nut is set on the base before the nut is rotated by the hub.

[0103] Figure 26K Is set in Figure 26F Nested fixtures on Figure 26H A perspective view of the base of FIG. 1 shows the state in which the nut is set on the base after the nut is rotated by the hub.

[0104] Figure 26L yes Figure 26A A perspective view of the nut and base of the tensioning mechanism of FIG. 1 at the end of the device's useful life, with the tensioning mechanism outputting an audible click.

[0105] Figure 26M yes Figure 26A A perspective view of the nut and base of the tensioning mechanism of FIG. 1 at the beginning of the device's service life.

[0106] Figure 26N yes Figure 26A Another perspective view of the nut and base of the tensioning mechanism of the device at a later stage in the useful life of the device, wherein the locking mechanism of the tensioning mechanism is triggered.

[0107] Figure 27A is with Figures 26A-26N A perspective view of another embodiment of a locking mechanism for use with a tensioning mechanism.

[0108] Figure 27B is used for Figures 26A-26N A perspective view of another embodiment of a locking mechanism of a tensioning mechanism.

[0109] Figure 27C is with Figures 26A-26N A perspective view of another embodiment of a locking mechanism for use with a tensioning mechanism.

[0110] Figure 27D yes Figure 27C Another perspective view of the locking mechanism. DETAILED DESCRIPTION

[0111] Specific embodiments of the present invention will now be described with reference to the accompanying drawings, in which like reference numerals represent identical or functionally similar elements. The following detailed description is merely exemplary in nature and is not intended to limit the invention or its application and uses. Although the present invention is described in the context of testing stent graft devices, the present invention can also be used to test other tubular prostheses that are considered useful. Furthermore, no intention is to be bound by any theory, expressed or implied, presented in the foregoing technical field, background technology, summary of the invention, or the following detailed description.

[0112] Embodiments of the present invention relate to an inhaler device configured to deliver powdered medicament from at least one blister strip, and more particularly, to a tensioning mechanism for maintaining consistent tension in the blister strips throughout the life of the device. The tensioning mechanism described herein is illustrated in an inhaler device configured to deliver powdered medicament from two blister strips simultaneously, but the tensioning mechanism may also be applied to inhaler devices that deliver powdered medicament from a single blister strip or from more than two blister strips.

[0113] Figure 1A 、 Figure 1B and Figure 1C 1 shows an inhaler device 100 according to an embodiment thereof. The inhaler device 100 includes a housing 102 and a mouthpiece cover 108. The housing 102 includes a display window 104 through which a number is displayed indicating the number of remaining doses of the inhaler device 100. The housing 102 also includes a plurality of openings or air inlets 106 formed through the sidewalls of the housing 102. As will be described in more detail herein, when a user inhales at the mouthpiece 110, air from outside the inhaler device 100 is drawn into the interior of the inhaler device 100 via the air inlets 106. Figure 1A and Figure 1B In FIG, the mouthpiece cover 108 of the inhaler device 100 is in a closed position, wherein the mouthpiece cover 108 covers or extends over the mouthpiece 110. Figure 1C In the embodiment of the present invention, the mouthpiece cover 108 is in the open position, so that the mouthpiece 110 is exposed and accessible to the user. Only when the mouthpiece cover 108 is in the open configuration can the user inhale the powdered medicament through the mouthpiece 110. The mouthpiece 110 includes a central outlet or opening 112 that allows the powdered medicament contained in the inhaler device 100 to be delivered to the user through inhalation.

[0114] exist Figure 1A and Figure 1B In the closed position, the mouthpiece 110 and the air inlet 106 are covered by the mouthpiece cover 108. When the user wishes to inhale a dose of medicine from the inhaler device 100, the mouthpiece cover 108 is opened. Figure 1A and Figure 1B The closed position moves to Figure 1CIn the open position, the mouthpiece cover 108 rotates or moves relative to the housing 102 so that the mouthpiece 110 and the air inlet 106 are fully exposed and no longer obstructed by any part of the mouthpiece cover 108. Since the instructions for use require the user to cover the central opening 112 of the mouthpiece 110 with their mouth when inhaling powdered medicament, the mouthpiece cover 108 can protect the mouthpiece 110 when the inhaler device 100 is not in use to prevent the airflow channel of the inhaler device 100 from being contaminated by unwanted particles, thereby avoiding adverse effects on the user's experience and / or dose delivery. As will be described in more detail herein, the movement of the mouthpiece cover 108 from the closed position to the open position actuates the dispensing mechanism in the inhaler device 100 to make the medicament dose available for inhalation, and further actuates the counting mechanism in the inhaler device 100 to reduce the number of remaining doses displayed in the display window 104 by one unit. Thus, the mouthpiece cover 108 not only serves to protect the central opening 112 of the mouthpiece 110, but also serves to operate the dispensing mechanism and the counting mechanism of the inhaler device 100. For each dose, the user only needs a single operating step, namely moving the mouthpiece cover 108, to activate the inhalation device 100.

[0115] In one embodiment, the user can rotate mouth cover 108 85 to 105 degrees, to expose mouth cover 110 and air inlet 106. When designing inhaler device 100, it is very important to ensure that the required power of actuating mouth cover 108 is enough little, so that the user with different physical ability levels can all operate easily. Generally speaking, when the stroke distance of mouth cover 108 is longer, in the dispensing mechanism of inhaler device, more favourable mechanical advantage is realized, thereby making for each dosage, rotating mouth cover 108 and actuating the required actuating force of inhaler device 100 are less. Yet, from the perspective of ergonomics, the shorter stroke distance of mouth cover 108 can avoid the user from changing the gripping posture during actuation. The shorter stroke distance of mouth cover 108 also makes housing 102 bigger for the user to hold during actuation, because mouth cover 108 is less through the zone of housing 102. The shorter stroke of the mouthpiece cover 108 also provides more space for other features of the inhaler device 100 and / or allows the size of the inhaler device 100 to be minimized. In one embodiment, a cover stroke between 90 degrees and 100 degrees can provide an optimal balance between the above factors. Figure 1A-Figure 1C As shown, the housing 102 includes an integral flange or step 102A formed thereon that controls or limits the rotational movement of the mouthpiece cover 108 to a desired range.

[0116] The force distribution in the stroke of mouthpiece cover 108 will affect the user's experience and the tactile feedback that inhaler device 100 provides. It is also desirable to keep a relatively consistent or constant actuating force in the stroke of mouthpiece cover 108, to avoid incorrect use or confusion. Making the entire stroke of mouthpiece cover 108 all participate in operating the dispensing mechanism, it is expected that the actuating force distribution will be more consistent, and help to alleviate the risk of misusing inhaler device 100. For example, in an inhaler device different from the present invention, the dispensing mechanism is not actuated in the initial stage when the mouthpiece cover moves, so the actuating force in this initial stage can be relatively low. When the dispensing mechanism is actuated, the actuating force of the mouthpiece cover increases. Therefore, in an inhaler different from the present invention, the actuating force of the mouthpiece cover significantly increases midway through the entire stroke of the mouthpiece cover, and the user may mistakenly perceive this change as a tactile feedback that suggests the mouthpiece cover has fully opened to take a dose. In other words, with regard to tactile feedback, a non-constant actuating force distribution may confuse the user and may cause the incorrect use of the device. Figure 1D The approximate actuation force profile of an inhaler device 100 having a mouthpiece cover 108 according to an embodiment herein is shown (represented by a dashed line) and compared with the approximate actuation force profile of an inhalation device described in the previous example (represented by a solid line) which does not actuate the dispensing mechanism during the initial period of the mouthpiece cover stroke. Figure 1D As shown by the solid line in FIG, when the dispensing mechanism is not actuated at the beginning of the mouthpiece stroke, there is a step in the actuation force distribution. Figure 1D As shown by the dashed line in FIG, when the dispensing mechanism is actuated at the beginning of the mouthpiece stroke as in the inhaler device 100, the actuation force is generally constant or consistent and the peak actuation force is lower.

[0117] The inhaler device 100 is configured to dispense dry powder medicament from two blister strips simultaneously. More specifically, referring to Figure 2, shows a first blister strip 160A and a second blister strip 160B. The inhaler device 100 described herein is configured to dispense medicine from each of the first blister strip 160A and the second blister strip 160B simultaneously. Each blister strip 160A, 160B includes a bottom sheet 162A, 162B, respectively, which defines a series or multiple independent blisters or cavities (pockets) 164A, 164B thereon. Each cavity 164A, 164B is configured to contain a dose or a portion of a dose of dry powder or powdered medicine 168A, 168B that will be inhaled by the user. In one embodiment, powdered medicine 168A is a different medicine from powdered medicine 168B, so that the inhaler device 100 is configured to deliver two different powdered medicines to the user simultaneously. Top sheets 166A, 166B are airtightly adhered or sealed to bottom sheets 162A, 162B, respectively, to enclose cavities 164A, 164B, and act as lids for cavities 164A, 164B, respectively, to contain powdered medicament 168A, 168B therein. The airtight seal of top sheets 166A, 166B allows bottom sheets 162A, 162B to be peeled away from top sheets 166A, 166B, thereby opening or exposing cavities 164A, 164B and providing access to powdered medicament 168A, 168B therein. Each of first blister strip 160A and second blister strip 160B is sufficiently flexible to be rolled into a roll.

[0118] As will be described in greater detail herein, when the dispensing mechanism of the inhaler device 100 is actuated by movement of the mouthpiece cover 108, the top sheets 166A, 166B of the blister strips 160A, 160B peel away from the bottom sheets 162A, 162B of the blister strips 160A, 160B, respectively, to open or expose the cavities 164A, 164B of each blister strip, thereby exposing the powdered medicament 168A, 168B disposed in the cavities 164A, 164B. Upon inhaling through the mouthpiece 110, the user simultaneously inhales the powdered medicament 168A, 168B from the opened cavities 164A, 164B of the blister strips 160A, 160B, respectively. Thus, the user receives a fixed metered dose of medicament powder, each dose consisting of a respective dose portion of medicament powder from the opened cavities 164A, 164B of the blister strips 160A, 160B. Each blister strip 160A, 160B may be the same size and / or contain the same dosage (eg, volume or mass) of the powdered medicament, or may be a different size and / or contain a different dosage of the powdered medicament.

[0119] Figure 3AFIG1 is a front view of the inhaler device 100 with the mouthpiece cover 108 in the open position and the housing 102 removed for illustration purposes only. The inhaler device 100 includes a manifold 114 for directing airflow through the manifold 114 to entrain and deliver powdered medicament 168A, 168B from blister strips 160A, 160B, respectively, to a user via the mouthpiece 110. The manifold 114 is in fluid communication with the mouthpiece 110 such that the powdered medicament 168A, 168B can be delivered to the user through the central opening 112 of the mouthpiece 110. In addition to the manifold 114, the inhaler device 100 also includes a dispensing subassembly or mechanism 120, a counter subassembly or mechanism 134, and tensioning subassemblies or mechanisms 151A, 151B. In the assembled state, each of the manifold 114 , the dispensing subassembly 120 , the counter subassembly 134 , and the tensioning mechanisms 151A, 151B are located or disposed within the housing 102 .

[0120] Reference here Figure 3B The operation of the manifold 114 is described. The manifold 114 defines an air path through the inhaler device 100. The manifold 114 fluidly connects the mouthpiece 110 to the first blister strip 160A and the second blister strip 160B. Figure 3B is a cross-sectional view taken along the manifold 114, illustrating the airflow path through the manifold 114 for entraining the medication 168B of the second blister strip 160B. Figure 10 As explained in FIG. 14 , the manifold 114 also defines an airflow path through the manifold 114 for entraining the medication 168A of the first blister strip 160A.

[0121] During use, the user rotates the mouthpiece cover 108 to expose the mouthpiece 110 and the air inlet 106. Inside the inhaler device 100, rotating the mouthpiece cover 108 exposes the powdered medicament 168A, 168B within the cavities 164A, 164B of each of the first and second blister strips 160A, 160B, respectively. To access the powdered medicament 168A, 168B within the opened cavities 164A, 164B, the user exhales or inhales through the mouthpiece 110. The user covers the central opening 112 of the mouthpiece 110 with their mouth and inhales, thereby creating a pressure differential between the air inlet 106 and the central opening 112, causing air to flow through the manifold 114. This pressure differential causes external air (i.e., air from outside the inhaler device 100) to enter the inhaler device 100 through the air inlet 106, pass through the opened cavities 164A, 164B, and exit the inhaler device 100 through the central opening 112. The airflow path defined by the manifold 114 is designed so that when the user inhales, the powdered medicament 168A, 168B exposed in the open cavities 164A, 164B is carried away by the airflow and delivered to the user as an orally inhaled combined medicament dose. In this way, the user can inhale a dose portion from each blister strip 160A, 160B at the same time.

[0122] The manifold 114 is configured to direct the inhaled airflow in a variety of ways to achieve airflow characteristics that are conducive to the efficient delivery of the powdered medicament. More specifically, as Figure 3B As shown, the geometry of the manifold 114 causes a portion of the inhaled airflow to enter and exit the open cavity 164B (at the Figure 3B The other part of the inhaled airflow passes through the guide structure or hole in the manifold 114 (which is marked with a dotted line 199). Figure 4-Figure 8 ). The portion of the inhaled airflow passing through the open cavity 164B entrains a dose of powdered medicament 168B in the airflow. The portion of the inhaled airflow passing through the flow-guiding structure in the manifold 114 intersects with the entrained airflow portion to break up the powdered medicament therein, and then both flow out of the manifold 114.

[0123] Steering Figure 4-Figure 8, the manifold 114 is described in more detail. The manifold 114 is configured to simultaneously deliver powdered medicaments 168A, 168B from corresponding open blister cavities 164A, 164B of each of the first and second blister strips 160A, 160B, respectively. The manifold 114 includes a body 170 that defines a first space or atrium 172A, a second space or atrium 172B, and a flow stack 180. As will be explained in more detail herein, the separate and distinct chambers or spaces of the first and second atrium 172A, 172B, and flow stack 180 can separate, divert, or otherwise partition an inhaled airflow drawn into the manifold 114 by a user into multiple airflow paths that pass through the body 170 of the manifold 114. More specifically, when an inhalation force is applied through the central opening 112 of the mouthpiece 110, an inhaled airflow is drawn into the first and second vestibular cavities 172A, 172B of the manifold 114 via the air inlet 106 of the inhaler device 100. The first and second vestibular cavities 172A, 172B are positioned adjacent to, or alongside, the air inlet 106. Once the inhaled airflow enters the manifold 1114, as it passes through the main body 170 of the manifold, it splits or forms four airflow paths: a first diverter airflow path 192, a second diverter airflow path 194, a first entrained airflow path 196, and a second entrained airflow path 198. In other words, each of the first diverter airflow path 192, the second diverter airflow path 194, the first entrained airflow path 196, and the second entrained airflow path 198 is a respective airflow portion of the inhaled airflow drawn into the manifold 114.

[0124] In this embodiment, a first vestibular chamber 172A and a second vestibular chamber 172B are disposed laterally adjacent to or side by side with one another on one side of the body 170 of the manifold 114. The first vestibular chamber 172A and the second vestibular chamber 172B are separated from one another by a partition wall 173 such that there is no fluid communication between the first vestibular chamber 172A and the second vestibular chamber 172B. The first vestibular chamber 172A includes a single vestibular chamber inlet 174A, and the second vestibular chamber 172B includes a single vestibular chamber inlet 174B. The vestibular chamber inlets 174A, 174B are separate from one another and may also be considered inlets to the manifold 114. Thus, the manifold 114 includes two inlets, with the vestibular chamber inlet 174A leading to or into the first vestibular chamber 172A and the vestibular chamber inlet 174B leading to or into the second vestibular chamber 172B.

[0125] The first vestibular cavity 172A includes a first vestibular cavity outlet 176A and a second vestibular cavity outlet 178A, and the second vestibular cavity 172B includes a first vestibular cavity outlet 176B and a second vestibular cavity outlet 178B. As will be explained in greater detail herein, the first vestibular cavity outlet 176A, 176B of each of the first and second vestibular cavities 172A, 172B, respectively, directs or guides fluid directly into the flow channel 180, and the second vestibular cavity outlet 178A, 178B of each of the first and second vestibular cavities 172A, 172B, respectively, directs or guides fluid into the open cavities 164A, 164B of the first and second blister strips 160A, 160B, respectively. In one embodiment, the first vestibular cavity outlets 176A, 176B are substantially rectangular or oval in outline or shape. However, the profile or shape of the first vestibular cavity outlet 176A, 176B is not limited to the shapes described herein and may alternatively be circular, triangular, or any other shape deemed suitable for the purposes described herein. Similarly, the profile or shape of the second vestibular cavity outlet 178A, 178B is substantially circular and includes a grille or cross-piece 197 (see FIG. Figure 4 ) to enhance turbulence in the airflow. However, the profile or shape of the second vestibular cavity outlets 178A, 178B is not limited to the shapes described herein, and may alternatively be rectangular, elliptical, oval, triangular, or any other shape deemed suitable for the purposes described herein, and may or may not include a grille across it.

[0126] like Figure 7As best shown, the flow channel 180 is in fluid communication with each of the first vestibule cavity 172A, the second vestibule cavity 172B, the open cavity 164A in the first blister strip 160A, and the open cavity 164B in the second blister strip 160B. The flow channel 180 has four inlets: a first flow channel inlet 182, a second flow channel inlet 184, a third flow channel inlet 186, and a fourth flow channel inlet 188. The first flow channel inlet 182 is aligned with the first vestibule cavity outlet 176A of the first vestibule cavity 172A, placing the flow channel 180 and the first vestibule cavity 172A in fluid communication with each other. The second flow channel inlet 184 is aligned with the open cavity 164A of the first blister strip 160A, placing the second flow channel inlet 184 in fluid communication with the second vestibule cavity outlet 178A of the first vestibule cavity 172A through the open cavity 164A. The third flow channel inlet 186 is in fluid communication with the second vestibule cavity outlet 176B of the second vestibule cavity 172B, thereby placing the flow channel 180 and the second vestibule cavity 172B in fluid communication with each other. The fourth flow channel inlet 188 is in fluid communication with the open cavity 164B of the second blister strip 160B, thereby further placing the fourth flow channel inlet 188 in fluid communication with the second vestibule cavity outlet 178B of the second vestibule cavity 172B through the open cavity 164B.

[0127] The profile or shape of each of the first and third flow channel inlets 182, 186 is substantially rectangular or elliptical. However, the profile or shape of the first and third flow channel inlets 182, 186 are not limited to the shapes described herein and may alternatively be circular, triangular, or any other shape deemed suitable for the purposes described herein. Similarly, the profile or shape of the second and fourth flow channel inlets 184, 188 are substantially circular and include a grille or cross member 195 (see FIG. Figure 4 ) to enhance turbulence in the airflow. However, the profile or shape of the second and fourth flow guide channel inlets 184, 188 is not limited to the shapes described herein and may alternatively be rectangular, elliptical, oval, triangular, or any other shape deemed suitable for the purposes described herein, and may or may not include a grille across it.

[0128] Flow guiding channel 180 is a single flow guiding channel with a single flow guiding channel outlet 190. Therefore, in the present embodiment, flow guiding channel 180 has only a flow guiding channel outlet 190. The flow guiding channel outlet 190 also can be considered to the outlet of manifold 114. Like this, manifold 114 only comprises an outlet. The shape or the outline of flow guiding channel outlet 190 are oval. Yet the outline or the shape of flow guiding channel outlet 190 are not limited to shape as herein described, and can alternatively be circle, rectangle, oval, triangle or be considered to any other shape that is suitable for purpose as herein described. When manifold 114 was assembled in the inhaler device 100, the flow guiding channel outlet 190 aligned with the central opening 112 of mouthpiece 110 and was communicated with on fluid.

[0129] The second vestibule cavity outlet 178A of the first vestibule cavity 172A is in fluid communication with the second flow channel inlet 184 to define a first entrainment airflow path 196 associated with the open blister cavities 164A of the first blister strip 160A. As the airflow flows through the open blister cavities 164A, the airflow entrains the powdered medicament 168A disposed within the open blister cavities 164A. Thus, by passing through the open blister cavities 164A, the powdered medicament 168A is drawn into and delivered into the flow channel 180 by the airflow. After entrainment, the airflow carries the powdered medicament 168A.

[0130] Similarly, the second vestibule cavity outlet 178B of the second vestibule cavity 172B is in fluid communication with the fourth flow channel inlet 188 to define a second entrainment airflow path 198 associated with the open blister cavities 164B of the second blister strip 160B. As the airflow flows through the open blister cavities 164B, it entrains the powdered medicament 168B disposed within the open blister cavities 164B. Thus, by passing through the open blister cavities 164B, the powdered medicament 168B is drawn in and delivered by the airflow into the flow channel 180. After entrainment, the airflow carries the powdered medicament 168B.

[0131] The first vestibule chamber outlet 176A of the first vestibule chamber 172A is communicated with the first guide channel inlet 182 in fluidic communication, to limit the first shunt airflow path 192 of manifold 114. Similarly, the first vestibule chamber outlet 176B of the second vestibule chamber 172B is communicated with the 3rd guide channel inlet 186 in fluidic communication, to limit the second shunt airflow path 194 of manifold 114. Compared with the first entrained airflow path 196 and the second entrained airflow path 198, each shunt airflow path 192, 194 provides the path of lower resistance for air to flow to the patient's oral cavity from the outside of inhaler device 100. Therefore, the total airflow resistance of inhaler device 100 reduces, thereby can realize higher overall flow rate under identical suction pressure. In addition, shunt airflow path 192, 194 provides the deagglomeration process to powdered medicament 168A, 168B before powdered medicament 168A, 168B leaves manifold 114. Each of first and second diverter airflow paths 192, 194 is configured to disrupt each of first and second entrainment airflow paths 196, 198 and break up the entrained medication. More specifically, first diverter airflow path 192 is directed into the path of first entrainment airflow path 196, which is angled at a different angle from first diverter airflow path 192. This creates a region of higher shear forces at the intersection between first and second diverter airflow paths 192, thereby enhancing the deagglomeration of powdered medication 168A prior to exiting manifold 114. Similarly, second diverter airflow path 194 is directed into the path of second entrainment airflow path 198, which is angled at a different angle from second diverter airflow path 194. An area of ​​higher shear is created at the intersection between the second diverging airflow path 194 and the second entraining airflow path 198, thereby enhancing the deagglomeration of the powdered medicament 168B prior to exiting the manifold 114. The first diverging airflow path 192, the second diverging airflow path 194, the first entraining airflow path 196, and the second entraining airflow path 198 combine or mix together within the flow channel 180 before exiting the manifold 114 together.

[0132] like Figure 8As shown in the flow chart of , the inhaled airflow from the inhaler device 100 outside suction separates between two inlets of manifold 114, promptly separates between the first vestibular cavity entrance 174A and the second vestibular cavity entrance 174B.Therefore, the inhaled airflow from the inhaler device outside suction enters the first vestibular cavity 172A and the second vestibular cavity 172B simultaneously.The first part of the inhaled airflow that enters the first vestibular cavity 172A flows into the blister cavity 164A that opens, and the second part of the inhaled airflow that enters the first vestibular cavity 172A directly flows into the flow guiding channel 180.The first part of the inhaled airflow in the blister cavity 164A that opens carries or carries entrained the powdered medicine 168A that is arranged on the blister cavity 164A that opens, and then continues to enter the flow guiding channel 180.In the flow guiding channel 180, the second part of the inhaled airflow from the first vestibular cavity 172A breaks up or disaggregates the powdered medicine 168A that carries entrained in the first part of the inhaled airflow. Similarly, a first portion of the inhaled airflow entering the second vestibular cavity 172B flows into the open blister cavity 164B, and a second portion of the inhaled airflow entering the second vestibular cavity 172B flows into the flow channel 180. The first portion of the inhaled airflow within the open blister cavity 164B carries or entrains the powdered medicament 168B disposed within the open blister cavity 164B and then continues into the flow channel 180. Within the flow channel 180, the second portion of the inhaled airflow from the second vestibular cavity 170B breaks up or deagglomerates the powdered medicament 168B entrained within the first portion of the inhaled airflow. Within the flow channel 180, all portions of the airflow are mixed together before entering the patient's oral cavity and exiting the manifold 114. The mixed airflow includes both medicament 168A from the first blister strip 160A and medicament 168B from the second blister strip 160B. Airflow through the first vestibule cavity 172A and the open blister cavity 164A occurs simultaneously with airflow through the second vestibule cavity 172B and the open blister cavity 164B.

[0133] Because the first vestibular cavity 172A and the second vestibular cavity 172B are separate and distinct compartments, the partition wall 173 extends between the first vestibular cavity 172A and the second vestibular cavity 172B, and the inhaled airflow entering the manifold 114 is directed to the outlet of each vestibular cavity. Directing the separated inhaled airflow into the open blister cavities 164A, 164B in this way reduces the turbulent energy in the airflow at this stage and thus reduces the overall airflow resistance of the inhaler device 100. The overall airflow resistance allows the patient to achieve a higher airflow rate at the same inhalation pressure, which can improve the effectiveness of drug delivery.

[0134] Now turn Figure 9A and Figure 9B, describes the dispensing subassembly 120 of the inhaler device 100 in more detail. The dispensing subassembly 120 is configured to advance each blister strip 160A, 160B and open its cavity 164A, 164B each time the user fully opens the mouthpiece cover 108. The first blister strip 160A and the second blister strip 160B are disposed within a first compartment 118A and a second compartment 118B within the housing 102. More specifically, the compartments 118A, 118B are formed by an internal chassis 116 disposed within the housing 102. Via the dispensing subassembly 120, the continuous cavities 164A, 164B of each blister strip 160A, 160B are directed to a manifold 114, which is disposed along the centerline of the inhaler device 100, or approximately along the centerline. When positioned at the manifold 114, the cavity 164A, 164B of each blister strip 160A, 160B has been opened and the powdered medicament 168A, 168B within the opened cavity of each blister strip 160A, 160B is available for inhalation. The empty bottom sheet 162A, 162B and top sheet 166A, 166B of the blister strips 160A, 160B are wound up by the dispensing subassembly 120 as described herein. Figure 9A is a front view of the inhaler device 100 with the mouthpiece cover 108 in an open position and with a front half or portion of the housing 102 of the inhaler device 100 removed for illustration purposes only. Figure 9B is a rear view of the inhaler device 100 with the mouthpiece cover 108 and housing 102 removed for illustration purposes only.

[0135] The dispensing subassembly 120 includes a central drive gear 122, a ratchet mechanism 124, a first idler gear or intermediate gear 126, a second idler gear or intermediate gear 127, a first bottom sheet take-up gear 128A and a second bottom sheet take-up gear 128B, a first index gear 130A and a second index gear 130B, and a first top sheet take-up gear 150A and a second top sheet take-up gear 150B. The first bottom sheet take-up gear 128A, the first index gear 130A, and the first top sheet take-up gear 150A are associated with advancing the first blister strip 160A, while the second bottom sheet take-up gear 128B, the second index gear 130B, and the second top sheet take-up gear 150B are associated with advancing the second blister strip 160B.

[0136] like Figure 11As shown, the first positioning gear 130A and the second positioning gear 130B are attached to or integrally formed with the first positioning reel 131A and the second positioning reel 131B, respectively. Each of the first positioning reel 131A and the second positioning reel 131B includes a pair of grooves 132A and 132B. Each groove in the pair of grooves 132A and 132B is configured to receive a cavity 164A and 164B of a blister strip 160A and 160B, respectively. Rotation of the first positioning gear 130A and the second positioning gear 130B causes the first positioning reel 131A and the second positioning reel 131B to rotate and operate to move the grooves 132A and 132B, respectively, adjacent to or juxtaposed with the manifold 114. As the blister strips 160A, 160B are advanced by the positioning reels 131A, 131B, the top sheets 166A, 166B of the blister strips 160A, 160B are peeled away from the bottom sheets 162A, 162B of the blister strips 160A, 160B, causing the cavities 164A, 164B adjacent the manifold 114 to open and the powdered medicament 168A, 168B in the cavities 164A, 164B to be entrained. More specifically, to expose each dose of powdered medicament 168A, 168B, the top sheets 166A, 166B are peeled away from the bottom sheets 162A, 162B, respectively, causing the cavities 164A, 164B in each bottom sheet 162A, 162B to be opened or exposed. The cavities 164A, 164B are exposed or opened by relative rotation between the positioning reels 131A, 131B and the top sheet take-up gears 150A, 150B. The positioning reels 131A, 131B substantially clamp the bottom sheets 162A, 162B, respectively, while the top sheet take-up gears 150A, 150B substantially clamp the top sheets 166A, 166B, respectively. When the positioning reels 131A, 131B and the top sheet take-up gears 150A, 150B rotate relative to each other, the bottom sheets 162A, 162B and the top sheets 166A, 166B peel away from each other. As will be described in greater detail herein, the positioning reels 131A, 131B and the top sheet take-up gears 150A, 150B are driven to rotate in opposite directions via a gear transmission, such that when the gears are driven, each top sheet 166A, 166B is peeled off from its corresponding bottom sheet 162A, 162B. Thus, the dispensing subassembly 120 opens the corresponding front cavity 164A, 164B and positions it in fluid communication with the manifold 114, making the powdered medicament 168A, 168B of the opened cavity 164A, 164B available for inhalation.

[0137] The first bottom sheet winding gear 128A and the second bottom sheet winding gear 128B are operated to wind up the empty bottom sheets 162A, 162B of the blister strips 160A, 160B, respectively. Figure 11 As shown, the first and second bottom sheet winding gears 128A and 128B are attached to or integrally formed with the main shafts 129A and 129B, respectively. As the first and second bottom sheet winding gears 128A and 128B rotate, the first and second main shafts 129A and 129B rotate accordingly and operate to wind up the bottom sheets 162A and 162B during operation of the inhaler device 100. The ends of each bottom sheet 162A and 162B are fixed to the first and second bottom sheet winding gears 128A and 128A, so that as the first and second bottom sheet winding gears 128A and 128B gradually rotate, the bottom sheets 162A and 162B are wound thereon to form a tight roll.

[0138] The first and second top sheet take-up gears 150A, 150B are operated to take up the top sheets 166A, 166B of the blister strips 160A, 160B, respectively. Figures 14A-14E As described in more detail, the first and second top sheet winding gears 150A, 150B are coupled to winding hubs 152A, 152B, respectively. As the first and second top sheet winding gears 150A, 150B rotate, the first and second winding hubs 152A, 152B rotate accordingly and operate to wind or reel in the top sheets 166A, 166B when the inhaler device 100 is in operation. Each end of the top sheet 166A, 166B is secured to the first and second winding hubs 152A, 152B, so that as the first and second top sheet winding gears 150A, 150B rotate, the top sheets 166A, 166B are wound thereon to form a tight roll.

[0139] The central drive gear 122 of the dispensing subassembly 120 is attached to the mouthpiece cover 108 via a ratchet mechanism 124. Figure 10 10. The ratchet mechanism 124 removed from the inhaler device 100 is shown in FIG. Ratchet mechanism 124 comprises a pawl 125 attached to the mouth cover 108 and a ratchet 123 integrally formed with or attached to the central drive gear 122. When the mouth cover 108 is opened, the pawl 125 is driven in the second opposite direction together with the mouth cover 108. The pawl 125 then drives the ratchet 123 in the second opposite direction to advance or drive the dispensing subassembly 120. When the mouth cover 108 returns to its closed position, the dispensing subassembly 120 is not advanced or actuated, but remains stationary. Therefore, the opening action of the mouth cover 108 is transmitted to the central drive gear 122, and the closing action of the mouth cover 108 can not be transmitted to the central drive gear 122.

[0140] More specifically, the ratchet 123 includes a plurality of circumferentially spaced inner stop surfaces 123A and outer stop surfaces 123B around its periphery or edge. The pawl 125 includes a plurality of flexible pawl arms 125A configured to interact with the circumferentially spaced inner stop surfaces 123A of the ratchet 123. When the mouth cover 108 moves from the closed first position to the open second position, the pawl 125 rotates in the first direction together with the mouth cover 108. Figure 10B As shown, when rotated in a first direction, pawl arms 125A engage and drive circumferentially spaced inner stop surfaces 123A of ratchet 123, thereby transmitting torque to central drive gear 122. Because ratchet 123 is attached to or integrally formed with central drive gear 122, central drive gear 122 rotates in the first direction simultaneously with mouthpiece cover 108. As described above, movement of mouthpiece cover 108 to the second position opens and positions cavities 164A, 164B of each blister strip 160A, 160B, thereby enabling a patient to subsequently inhale powdered medicament 168A, 168B simultaneously.

[0141] However, when the mouthpiece cover 108 returns to its closed first position, the reverse rotation of the pawl 125 is not transmitted to the center drive gear 122 because the pawl arm 125A does not interact with the inner stop surface 123A of the ratchet wheel 123. More specifically, when the pawl 125 rotates in the second opposite direction (i.e., counterclockwise), the pawl arm 125A deflects radially inward, so that no significant torque is transmitted to the ratchet wheel 123 and the center drive gear 122. Figure 10A As shown, frictional resistance between the pawl 125 and the ratchet 123 may tend to briefly drive the ratchet 123 in a second, opposite direction (i.e., counterclockwise), but such back-winding is prevented by interaction between an outer stop surface 123B of the ratchet 123 and a retainer arm 121 on a retainer plate in the inhaler device 100.

[0142] In one embodiment, a detent (not shown) may be disposed between the inner surface of the mouth cover 108 and the outer surface of the housing 102. The detent may be a matching protrusion and groove configured to temporarily block or prevent movement of the mouth cover 108 relative to the housing 102 until a user applies a force to the mouth cover 108 (i.e., when opening the mouth cover 108) to release the detent by causing one of the matching features of the detent to exit or move beyond another of the matching features of the detent. For example, a protrusion, ridge, or other raised structure may be formed on the outer surface of the housing 102, and a matching groove, pit, or other recessed structure may be formed on the inner surface of the mouth cover 108. Alternatively, a protrusion, ridge, or other raised structure may be formed on the inner surface of the mouth cover 108, and a matching groove, pit, or other recessed structure may be formed on the outer surface of the housing 102. When the mouth cover 108 is in Figure 1A When the user applies a force sufficient to overcome the friction between the mating protrusion and the groove, the mouthpiece cover 108 begins to open and move away from the mouthpiece cover 108. Figure 1A The stop structure is configured to prevent or inhibit accidental opening of the mouthpiece cover 108. In addition, the stop structure is configured to account for rotational play or tolerances within the ratchet mechanism 124, so that the dispensing mechanism and the counting mechanism in the inhaler device 100 are actuated upon the first or initial movement of the mouthpiece cover 108 away from the closed position toward the open position.

[0143] like Figure 11 As shown, the central drive gear 122 directly or indirectly drives the remaining gears of the dispensing subassembly 120. The gear train arrangement enables incremental indexing or advancement of the blister strips 160A, 160B via the first and second positioning gears 130A, 130B, and also enables winding of the top and bottom sheets of the blister strips 160A, 160B (via the top sheet take-up gears 150A, 150B and the bottom sheet take-up gears 128A, 128B, respectively) as a result of rotational movement of the mouthpiece cover 108 in a first direction from its closed first position to its open second position. As the central drive gear 122 rotates with the mouthpiece cover 108 in the first direction, it cooperates with or directly drives the second positioning gear 130B to rotate in a second, opposite direction. The second reel 131B, and thereby the second blister strip 160B, also rotates in the second, opposite direction. When the second positioning gear 130B rotates in the second opposite direction, the second positioning gear 130B engages with the first positioning gear 130A or directly drives the first positioning gear 130A to rotate in the first direction. The first positioning reel 131A and the first blister strip 160A driven thereby also rotate in the first direction.

[0144] In one embodiment, the first direction is clockwise, and the second, opposite direction is counterclockwise. In the illustrated embodiment, when the mouthpiece cover 108 is opened, the center drive gear 122 rotates in a clockwise direction. Consequently, the second positioning gear 130B (along with the second reel 131B and the second blister strip 160B) rotates in a counterclockwise direction, while the first positioning gear 130A (along with the first positioning reel 131A and the first blister strip 160A) rotates in a clockwise direction. However, as one of ordinary skill in the art will appreciate, the first direction may alternatively be counterclockwise, while the second, opposite direction may be clockwise, as long as the gear train formed by the dispensing subassembly 120 moves or advances the first blister strip 160A in opposite directions from the second blister strip 160B. Furthermore, as one of ordinary skill in the art will appreciate, the gear train formed by the dispensing subassembly 120 may include one or more idler gears (not shown) that are used to change the rotational order between the center drive gear 122, the second positioning gear 130B, and the first positioning gear 130A. As long as the gear train moves or advances the first blister strip 160A in the opposite direction from the second blister strip 160B, the presence of such an idler gear does not affect the overall function of the gear train. For example, an idler gear (not shown) can be provided between the central drive gear 122 and the first positioning gear 130A, and the central drive gear 122 (rotating in a first direction) directly drives the idler gear to rotate in a second, opposite direction. The idler gear can be positioned so as to directly drive the first positioning gear 130A in the first direction, and the first positioning gear 130A directly drives the second positioning gear 130B in the second, opposite direction.

[0145] To maintain tension on the blister strips 160A and 160B, the first bottom sheet take-up gear 128A and the second bottom sheet take-up gear 128B rotate simultaneously with and in the same direction as the first positioning gear 130A and the second positioning gear 130B, respectively, and the first top sheet take-up gear 150A and the second top sheet take-up gear 150B rotate simultaneously with and in opposite directions as the first positioning gear 130A and the second positioning gear 130B, respectively. When the center drive gear 122 rotates in a first direction, the center drive gear 122 meshes with the first idler gear 126 or directly drives the first idler gear 126 to rotate in a second, opposite direction, and the first idler gear 126 meshes with the first bottom sheet take-up gear 128A or directly drives the first bottom sheet take-up gear 128A to rotate in the first direction. The first spindle 129A and the bottom sheet 162A wound thereby also rotate in the first direction, thereby winding or reeling in the empty bottom sheet 162A of the first blister strip 160A as the first blister strip 160A is advanced by the dispensing subassembly 120. Furthermore, the first top sheet reeling gear 150A interacts with or is driven by the first positioning gear 130A. As the first positioning gear 130A rotates in the first direction, the first top sheet reeling gear 150A is driven to rotate in a second, opposite direction to reel in the top sheet 166A of the first blister strip 160A.

[0146] When the central drive gear 122 rotates in the first direction, as described above, the first idler gear 126 is driven to rotate in the second, opposite direction. The first idler gear 126 engages with or directly drives the second idler gear 127 to rotate in the first direction. The second idler gear 127 engages with or directly drives the second bottom sheet take-up gear 128B to rotate in the second direction. Consequently, the second main shaft 129B and the bottom sheet 162B wound thereby also rotate in the second direction, thereby winding or rewinding the empty bottom sheet 162B of the second blister strip 160B as the second blister strip 160B is advanced by the dispensing subassembly 120. Furthermore, the second top sheet take-up gear 150B interacts with or is driven by the second positioning gear 130B. As the second positioning gear 130B rotates in the second opposite direction, the second top sheet take-up gear 150B is driven to rotate in the first direction to take up the top sheet 166B of the second blister strip 160B.

[0147] Now turn Figures 12A-12D, the counter subassembly 134 will be described in more detail. The dispensing subassembly 120 preferably directly drives the counter subassembly 134, so that the dose counter automatically increments when the inhalation device 100 positions or delivers a dose of medication. Therefore, the user does not need to perform any additional steps to update the dose counter, other than operating the mouthpiece cover 108 to activate the dispensing subassembly 120. The dose counter automatically increments when the mouthpiece cover 108 is opened, allowing the user to intuitively understand the dose counter indication.

[0148] The counter subassembly 134 includes a first counting wheel or units ring 140 and a second counting component or tens mechanism 136. The first counting wheel 140 is driven by the dispensing subassembly 120 of the inhaler device 100 to rotate a fixed angle at each administered dose, and in this embodiment, the first counting wheel 140 is configured to display the second digit of a two-digit count of available doses. The second counting component 136 is intermittently driven by the first counting wheel 140 so that the second counting component 136 rotates a fixed angle for each revolution of the first counting wheel 140, which will be described in more detail below. In this embodiment, the second counting component 136 displays the first digit of a two-digit count of available doses. Therefore, as Figure 12A and Figure 12B As shown, the first count wheel 140 and the second count component 136 together display the number of doses remaining in the inhaler device 100. Although the embodiment of the counter subassembly described herein displays two digits, it will be understood by those skilled in the art that if the total number of doses in the inhaler device exceeds 100, the count indicia may be modified to display three digits.

[0149] The front surface or indicia display surface or indicia display surface 141 of the first counting wheel 140 includes count indicia disposed thereon, the count indicia including the unit digit or "ones" digit. More specifically, as shown in FIG. Figure 12A and Figure 12B As shown, the counting marks of the first counting wheel 140 include the numbers 0, 1, 2, 3, 4, 5, 6, 7, 8, and 9, which are distributed in a circular manner near the outer edge of the marking display surface 141. The angle between each number is equal to the angle that the first counting wheel 140 rotates for each dose. The marking display surface 141 is a planar structure.

[0150] The front surface, or indicia display surface, or indicia display surface 137, of the second counter member 136 includes count indicia disposed thereon, including the tens digit. The count indicia of the second counter member 136 include the numerals 3, 2, and 1, and may also include a single mark SF and a double mark DF near the outer edge of the indicia display surface 137. The angle between each count indicia or numeral represents the angle through which the second counter member 136 rotates for each rotation of the first count wheel 140. The indicia display surface 137 is a planar structure.

[0151] The display window 104 in the housing 102 is positioned so that a numeral on the first count wheel 140 and a numeral on the second count unit 136 are visible in the display window, and are adjacent to each other to form two digits. The numeral that shows on the second count unit 136 reflects or tracks " tens " digits of residual dose in the inhaler device 100, and the numeral that shows on the first count wheel 140 reflects or tracks " individuals " digits of residual dose. When the quantity of residual dose was lower than 10, the second count unit 136 would show single mark SF in the display window 104, rather than numeral zero or in place of numeral zero. For example, in one embodiment, single mark SF could be a colored block without numerals thereon, to indicate that available dose is about to run out to the user in the inhaler device 100. When the quantity of residual dose reached zero, the second count unit 136 would show double mark DF in the display window 104, to substitute numerals. In one embodiment, for example, double mark DF could be a colored block without numerals thereon, which covers the numeral of the first count wheel 140, to provide the user with the clear visual feedback that there is no residual dose in the inhaler device 100. The double marking DF is configured to cover the numbers of the first count wheel 140 when no dose remains in the inhaler device 100 .

[0152] exist Figures 12A-12D In the embodiment of the present invention, the units or "ones" digits are arranged in a decreasing order in a first direction around the circumference of the first count wheel 140, while the "tens" digits are arranged in a decreasing order in a second, opposite direction around the periphery of the second counter component 136. Although the counter subassembly is described herein as displaying the number of doses remaining in the inhaler device 100, one of ordinary skill in the art will appreciate that the counter subassembly can be modified to display the number of doses delivered by the inhaler device by reversing the order of the count indicia provided on the counter subassembly.

[0153] Now turn Figure 12C and Figure 12D , the structure and operation of the first counting wheel 140 and the second counting member 136 will be described in more detail. Figure 12C It is along Figure 12B A cross-sectional view taken along line CC of the counter subassembly is located midway between the marking display surface and the opposing rear surface. Figure 12D It is along Figure 12C DD, which is adjacent to the opposite rear surface of the counter subassembly. The terms "front" and "rear" are used herein for illustrative purposes only and are meant to refer to the conventional grip of a user when using an inhalation device, wherein the front side of the device includes a display window for the counter mechanism.

[0154] The first count wheel 140 is an annular or ring-shaped member having a front surface or indicia display surface 141 and an opposing rear surface including a count gear 148, as shown. Figure 12D . The counter gear 148 can be integrally formed with the first count wheel 140 or attached to the first count wheel 140. An outer circumferential surface or outer circumferential side surface 143 extends between the front and rear surfaces of the first count wheel 140. The outer circumferential side surface 143 can be stepped, with a smaller diameter along the rear surface of the first count wheel 140 and a larger diameter along the front surface of the first count wheel 140. By comparison Figure 12C and Figure 12D The relative diameters in FIG. 1 and FIG. 2 show the stepped features of the outer circumferential side surface 143. In other words, the outer diameter of the mark display surface 141 of the first counting wheel 140 is greater than the outer diameter of the counting gear 148.

[0155] Adjacent the count gear 148, the first count wheel 140 includes a single tooth or protrusion 142 extending radially outward from an outer circumferential side surface 143. Along a front surface or indicia display surface 141 of the first count wheel 140, the outer circumferential side surface 143 is generally circular with a clearance cutout or clearance indent 145 formed around the single tooth 142. The function of the clearance indent 145 will be described in more detail below.

[0156] The second counting member 136 is configured to rotate about a pivot point 147. Figure 12C and Figure 12D As shown in the cross-sectional view of FIG, the second counter member 136 is a non-annular or partially disc-shaped member having a front surface or indicia display surface 137 and an opposite rear surface, the rear surface including a plurality of notches 138. An outer surface or outer side 139 extends between the front and rear surfaces of the second counter member 136. The outer side 139 can be stepped, having a smaller radial dimension along the rear surface of the second counter member 136 and a larger radial dimension along the front surface of the second counter member. By comparison Figure 12B and Figure 12C The relative diameters of the middle and outer side surfaces 139 and the stepped features of the outer side surface 139 are clearly visible.

[0157] 137. A plurality of notches 138 are formed in the lateral surface 139 of the second counter unit 136 and do not extend through the front surface or the marking display surface 137. In one embodiment, the second counter unit 136 comprises four notches 138, but the quantity of the notches is exemplary and depends on the capacity or the total number of available doses in the inhaler device 100. Each notch 138 extends radially inwardly towards the pivot point 147 of the second counter unit 136 and is configured to cooperate with or receive the single tooth 142 of the first count wheel 140. The lateral surface 139 of the second counter unit 136 can be considered to comprise a plurality of segmented portions 135, and each segmented portion 135 extends between two adjacent or contiguous notches 138. Along each segmented portion 135, the lateral surface 139 of the second counter unit 136 is concave, and forms an inverted bend or an arcuate recess 133 that matches the outer circumferential side 143 of the first count wheel 140.

[0158] The first counter wheel 140 is driven by the second bottom sheet take-up gear 128B of the dispensing subassembly 120, rotating a fixed angle for each dose dispensed. More specifically, a drive gear 144 is attached to opposite ends of the second spindle 129B of the second bottom sheet take-up gear 128B, allowing the drive gear 144, the second spindle 129B, and the second bottom sheet take-up gear 128B to rotate synchronously as a single component. When the mouthpiece cover 108 is opened, the drive gear 144 rotates in conjunction with the second bottom sheet take-up gear 128B in a second, opposite direction. The drive gear 144 cooperates with or directly drives the idler gear 146 to rotate in the first direction, while the idler gear 146 cooperates with or directly drives the counter gear 148 to rotate in the second, opposite direction. Consequently, the counter gear 148 rotates in the same direction as the drive gear 144. It is obvious to those skilled in the art that the rotation of the transmission gear 144 and the counting gear 148 in the same direction can also be achieved by a gear train, wherein the transmission gear 144 directly drives the counting gear 148 in the same direction. Figures 12B-12D As shown, when the counter gear 148 is an internal gear and the transmission gear 144 is a spur gear or planetary gear, the transmission gear 144 meshes with or directly drives the internal counter gear 148 in the same direction, thereby achieving the desired rotation scheme. The first count wheel 140 is attached to the count gear 148 so as to rotate together as an integral component, so that when the mouthpiece cover 108 is opened, the first count wheel 140 rotates in a second, opposite direction. Therefore, various suitable gear trains can be used herein to enable the transmission gear 144 and the counter gear 148 to rotate in the same direction.

[0159] like Figure 12CAs best shown in FIG, the second counter member 136 is positioned adjacent to or in close proximity to the outer circumferential side 143 of the first count wheel 140 such that a single tooth 142 of the first count wheel 140 engages one of the plurality of notches 138 of the second counter member 136 once per rotation of the first count wheel 140, thereby intermittently rotating the second counter member 136. In other words, each time the first count wheel 140 completes one full rotation, the single tooth 142 engages the notch 138 of the second counter member 136 and rotates or turns the second counter member 136 a fixed amount. Thus, the second counter member 136 rotates a fixed amount for each rotation of the first count wheel 140. Because the first count wheel 140 directly drives the second counter member 136, the second counter member 136 rotates in the opposite direction of the first count wheel 140. Figures 12A-12D In the embodiment of the present invention, the second counter member 136 is configured to rotate in a first direction and the first counter wheel 140 is configured to rotate in a second, opposite direction. When the single tooth 142 of the first counter wheel 140 does not engage the notch 138 of the second counter member 136, the second counter member 136 remains stationary and does not rotate.

[0160] The second counting member 136 is disposed adjacent to or alongside the first counting wheel 140 in the same plane, so that the second counting member 136 rotates on a different rotational axis than the first counting wheel 140. In other words, the first counting wheel 140 rotates about a first axis, and the second counting member 136 rotates about a second axis that is parallel to and spaced apart from the first axis.

[0161] As described above, along each segment 135, the outer side surface 139 of the second counting member 136 is concave and forms an arcuate notch 133 that matches the outer circumferential side surface 143 of the first counting wheel 140. Figure 12C As best shown, the geometry of the arcuate notch 133 matches the circular profile of the first count wheel 140 to prevent the second counter member 136 from inadvertently rotating when not engaged with the first count wheel 140. Specifically, the geometry or profile of the outer side 139 of the second counter member 136 ensures that the second counter member 136 does not rotate but remains stationary when a single tooth 142 of the first count wheel 140 is not engaged with a notch 138 of the second counter member 136. Conversely, when a single tooth 142 of the first count wheel 140 is engaged with or received within a notch 138 of the second counter member 136, a clearance notch 145 of the first count wheel 140 allows the second counter member 136 to briefly rotate with the first count wheel 140 to change the display of the tens digit.

[0162] Now go to Figure 13A 、 Figure 13B and Figures 14A-14EThe first and second tensioning mechanisms 151A, 151B will be described in greater detail. The tensioning mechanisms 151A, 151B are used to peel the top sheets 166A, 166B from the first and second blister strips 160A, 160B, respectively, to maintain a consistent peel distance or amount over the life of the device. More specifically, the tensioning mechanisms 151A, 151B ensure that the peel distance of the top sheets 166A, 166B is configured to appropriately open the cavities 164A, 164B for each dose, thereby enabling efficient dispensing of the powdered medicament 168A, 168B to the user. If the peel distance or amount is too low, the cavities may not be fully exposed, making it more difficult to adequately expel the powdered medicament contained therein during inhalation. Furthermore, if the peel distance or amount is too high, the next or subsequent cavities may be exposed prematurely, risking loss of some of the medicament contained therein, which may result in an underdose during the next dispensing. Tensioning mechanism 151A, 151B is also used to keep the sheet tension force of top sheet 166A, 166B during the device service life.Top sheet 166A, 166B need to be in consistent tension force, to guarantee the correct operation of inhaler device 100.The tension force of each top sheet 166A, 166B is associated with user-operated inhaler device 100 and mobile mouth cover 108 required forces.Therefore, guarantee that consistent tension force among top sheet 166A, 166B provides more consistent user experience during the device service life.The tension force that remains consistent in top sheet 166A, 166B also brings more consistent and lower peak mechanical stress in top sheet 166A, 166B and the surrounding components, thereby reduced the risk of mechanical failure during use.

[0163] The first tensioning mechanism 151A is associated with the first top sheet take-up gear 150A for taking up the top sheet 166A of the first blister strip 160A, and the second tensioning mechanism 151B is associated with the second top sheet take-up gear 150B (see FIG. Figure 9A and Figure 9B ), for winding the top sheet 166B of the second blister strip 160B. For the sake of brevity, only the first tensioning mechanism 151A will be described below, because the second tensioning mechanism 151B operates in the same manner. It will be apparent to those skilled in the art that certain features or components of the second tensioning mechanism 151B (i.e., the cam surface described herein) will be modified to extend in the opposite direction to that described below, so that the second tensioning mechanism 151B is configured to operate in the opposite direction to the first tensioning mechanism 151A. Advantageously, the first tensioning mechanism 151A and the second tensioning mechanism 151B use some components of the same design (i.e., the compression spring and take-up hub described herein), which helps to reduce manufacturing and assembly costs compared to other inhaler devices that manufacture dedicated components for each side of the device to achieve operation in opposite directions.

[0164] The tensioning mechanism 151A includes a first top sheet take-up gear 150A, a take-up hub 152A having a hook portion 153A integrally formed thereon or fixed thereto, a base 154A having a cam surface 155A integrally formed thereon or fixed thereto, a nut 156A, a shaft 157A, and a compression spring 158A extending or disposed between the nut 156A and the top end of the take-up hub 152A. The compression spring 158A biases the nut 156A downwardly toward the base 154A into the cam surface 155A. The compression spring 158A is disposed around or around the shaft 157A and longitudinally or axially adjacent to the nut 156A. The take-up hub 152A is disposed around or around the nut 156A and the compression spring 158A. In other words, the take-up hub 152A surrounds or encloses the nut 156A and the compression spring 158A contained therein.

[0165] The top sheet 166A of the first blister strip 160A is fixed or attached to the take-up hub 152A by the hook portion 153A so that when the take-up hub 152A rotates, the top sheet 166A of the first blister strip 160A is wrapped around it. The hook portion 153A is configured to be attached to the front end of the top sheet 166A so that the rotation of the take-up hub 152A causes the top sheet 166A to be wrapped around or wound around the take-up hub 152A. Since the take-up hub 152A may complete multiple rotations during the service life of the inhaler device 100, the top sheet 166A of the first blister strip 160A may be wrapped around itself multiple times, causing its radial position on the take-up hub 152A to increase, i.e., the radial distance of the top sheet 166A from each subsequent wrapping of the take-up hub 152A increases with each wrapping. Because rotation of the base 154A corresponds to rotation of the first top sheet take-up gear 150A, the base 154A rotates a fixed amount for each dose, and the distance that the top sheet 166A of the first blister strip 160A peels away from the bottom sheet 162A is determined by the tangential travel of the top sheet 166A of the first blister strip 160A at the take-up hub 152A. This tangential travel can be calculated as θ*r, where θ is the rotation angle of the take-up hub 152A per dose, and r is the radial position of the top sheet 166A of the first blister strip 160A on the take-up hub 152A. As the radial position of the top sheet 166A of the first blister strip 160A increases, the tangential travel increases for a fixed rotation of the take-up hub 152A. Without any modifications to the mechanism, the top sheet 166A of the first blister strip 160A will peel further away from the bottom sheet 162A later in the device's life. This is called the winding effect and is achieved by Figure 13A and Figure 13B to illustrate with comparison. Figure 13A is a schematic diagram of the first blister strip 160A at the beginning of the device's service life, Figure 13B is a schematic diagram of the first blister strip 160A at a later stage in the useful life of the device. Figure 13B It is shown that as the first blister strip 160A is wrapped around the take-up hub 152A, the effective diameter of the take-up hub 152A increases.

[0166] To ensure that the top sheet 166A of the first blister strip 160A is peeled the same amount each time and to compensate for wrapping effects, the tensioning mechanism 151A includes a cam surface 155A, a nut 156A, and a compression spring 158A. The cam surface 155A, nut 156A, and compression spring 158A function to provide a constant driving tension to the top sheet 166A throughout the entire strip length. As will be described in greater detail herein, increased tension along the top sheet 166A causes the take-up hub 152A to rotate relative to the base 154A, reducing the tension along the top sheet 166A. As the take-up hub 152A rotates relative to the base, the compression spring 158A is compressed, and the axial compression of the compression spring 158A is converted into a torque applied to the take-up hub 152A.

[0167] refer to Figures 14B-14D , the structure of the tensioning mechanism 151A will be described in more detail. The base 154A is attached to the first top sheet winding gear 150A or is integrally formed with the first top sheet winding gear 150A so as to rotate as an integral component when the first top sheet winding gear 150A is rotationally driven. For example, the base 154A may include a plurality of gear teeth integrally formed with or fixed to its outer peripheral surface to form the first top sheet winding gear 150A. The shaft 157A extends from the base 154A and is attached to the base 154A or is integrally formed with the base 154A so as to rotate together with the base 154A. Therefore, when the first top sheet winding gear 150A is rotationally driven, the shaft 157A, the base 154A, and the first top sheet winding gear 150A rotate as an integral component.

[0168] The nut 156A is disposed between the take-up hub 152A and the base 154A and is coupled to each of the take-up hub 152A and the base 154A. The nut 156A is disposed on the periphery of the shaft 157A or is disposed around the shaft 157A and is coupled to the base 154A by at least one inwardly extending rib 119A that protrudes or extends radially inward from the inner circumferential surface of the nut 156A. In one embodiment, the nut 156A includes a plurality of inwardly extending ribs 119A that serve as cam followers. In one embodiment, the plurality of inwardly extending ribs 119A are spaced circumferentially at equal increments. More specifically, as shown in FIG. Figure 14CAs shown, the inwardly extending ribs 119A of the nut 156A are disposed on and engage the cam surface 155A of the base 154A. In addition, the nut 156A is coupled to the take-up hub 152A via a spline connection 159A, such that the take-up hub 152A rotates with the nut 156A and does not allow relative rotation between the take-up hub 152A and the nut 156A. In other words, due to the presence of the spline connection 159A, the take-up hub 152A is rotationally locked to the nut 156A, such that the nut 156A and the take-up hub 152A rotate as a single unit. Figure 14C As best shown, the spline connection 159A includes an outwardly extending rib 117A that projects or extends radially outward from the outer circumferential surface of the nut 156A and is received within the axial groove 115A of the take-up hub 152A. The outwardly extending rib 117A is permitted to slide or move axially along the axial groove 115A, thereby permitting the nut 156A to slide or move axially relative to the take-up hub 152A, but the outwardly extending rib 117A does not permit the nut 156A to rotate relative to the take-up hub 152A.

[0169] When the base 154A rotates in the second opposite direction together with the first top sheet take-up gear 150A, the nut 156A and the take-up hub 152A also rotate in the second opposite direction due to the interaction between the nut 156A, the compression spring 158A, and the cam surface 155A of the base 154A. More specifically, when the base 154A is rotationally driven in the second opposite direction, the take-up hub 152A is configured to rotate in the second opposite direction by the engagement of the inwardly extending ribs 119A of the nut 156A with the cam surface 155A. Figure 14DAs shown, cam surface 155A includes alternating portions of vertical surface 111A and portions of angled or inclined surface 113A. Vertical surface 111A extends generally parallel to the longitudinal axis of shaft 157A. When base 154A is rotationally driven in a second, opposite direction (i.e., counterclockwise in this embodiment), nut 156A and the winding hub 152A, which is rotationally locked thereto, rotate along with base 154A in the second, opposite direction. The interaction between compression spring 158A, nut 156A, and cam surface 155A causes cam surface 155A to apply a torque to nut 156A in a direction that pushes nut 156A down cam surface 155A. Compression spring 158A presses nut 156A against inclined surface 113A of cam surface 155A, which applies a torque to winding hub 152A, thereby driving winding hub 152A in the second, opposite direction. Due to this interaction, when the base 154A moves counterclockwise, the nut 156A and the take-up hub 152A also rotate counterclockwise with the base 154A. It will be understood by those skilled in the art that the structure of the cam surface 155A is exemplary. The cam surface 155A can be a threaded or other inclined surface.

[0170] Although the take-up hub 152A rotates along with the base 154A in the second, opposite direction due to the interaction between the nut 156A, the compression spring 158A, and the cam surface 155A of the base 154A, relative rotation is permitted between the take-up hub 152A and the base 154A. More specifically, when sufficient torque is applied between the take-up hub 152A and the base 154A, the take-up hub 152A will rotate relative to the base 154A. Because the take-up hub 152A is permitted to rotate relative to the base 154A in a direction that reduces the tension in the top sheet 166A (i.e., in the first direction), this relative rotation stabilizes or balances the tension in the top sheet 166A via the deflection of the compression spring 158A. Thus, the tensioning mechanism 151A acts as a torsion or torque limiter between the take-up hub 152A and the base 154A to control the tension in the top sheet 166A of the first blister strip 160A.

[0171] In addition to the torque applied to nut 156A by cam surface 155A, there is another torque acting in the opposite direction on nut 156A, resulting from the interaction between nut 156A and take-up hub 152A via outwardly extending ribs 117A. This opposing torque results from the tension in top sheet 166A, which acts to apply torque to take-up hub 152A. The two opposing torques on nut 156A are in equilibrium, so compression spring 158A (via nut 156A and cam surface 155A) effectively balances the tension in top sheet 166A. If the tension in top sheet 166A increases, nut 156A will move further upward along cam surface 155A, and the force of compression spring 158A will increase, compensating for the increased tension.

[0172] More specifically, due to the aforementioned wrapping effect, the radial position of the top sheet 166A of the first blister strip 160A increases as the take-up hub 152A rotates. Due to this increase in radial position, the take-up hub 152A attempts to peel off a longer length of the top sheet 166A. This, combined with the change in the peeling angle between the top sheet 166A of the first blister strip 160A and the bottom sheet 162A of the first blister strip 160A, increases the tension on the top sheet 166A. As the tension on the top sheet 166A increases, the torque applied by the top sheet 166A to the take-up hub 152A also increases. However, this torque does not continue to increase. Instead, the take-up hub 152A begins to rotate in the second direction relative to the base 154A, and the nut 156A spirally moves upward along the cam surface 155A of the base 154A, thereby compressing the compression spring 158A. More specifically, when the take-up hub 152A and the nut 156A rotationally locked thereto begin to rotate in the second direction due to increased tension on the top sheet 166A, the base 154A and the cam surface 155A remain stationary, and the inwardly extending rib 119A of the nut 156A moves along the inclined surface 113A of the cam surface 155A in a direction toward the compression spring 158A, i.e., upwardly along the cam surface 155A. As the nut 156A presses against the compression spring 158A, the compression spring 158A is compressed. As the nut 156A moves relative to the base 154A, the nut 156A also moves axially relative to the take-up hub 152A because the outwardly extending rib 117A of the nut 156A is allowed to move axially within the axial groove 115A of the take-up hub 152A. Thus, rotation of the take-up hub 152A relative to the base 154A causes the nut 156A to move axially relative to the take-up hub 152A and relative to the base 154A, and further axial movement of the nut 156A toward the compression spring 158A axially compresses the compression spring 158A. Because the take-up hub 152A is rotationally locked to the nut 156A via the spline connection 159A, the nut 156A converts the axial force of the compression spring 158A into a torque applied to the take-up hub 152A. The combination of the compression spring 158A, the nut 156A, and the cam surface 155A thus provides a torque that acts to resist or counteract the relative rotation between the take-up hub 152A and the base 154A, thereby maintaining consistent tension in the top sheet 166A.

[0173] The take-up hub 152A is axially restrained relative to the base 154A by providing a clamp or retaining structure 149A between the shaft 157A and the take-up hub 152A. More specifically, the retaining structure 149A (at the Figure 14B154A) is disposed between the top end of the take-up hub 152A and the compression spring 158A to maintain the correct relative axial position between the take-up hub 152A and the base 154A. The retaining structure 149A may be a clamp, a bayonet structure, or other suitable component for maintaining the correct relative axial position between the take-up hub 152A and the base 154A. In another embodiment (not shown), the retaining structure may be attached to the interior of the housing 102 to maintain the correct relative axial position between the take-up hub 152A and the base 154A.

[0174] Figure 14E The figure illustrates the changing position of nut 156A throughout the life of the device. In the initial assembly state shown in the left figure, before the take-up hub 152A is attached to the first blister strip 160A, nut 156A is located at the bottom end of cam surface 155A. Cam surface 155A is designed so that in this position, even with the potential axial force from compression spring 158A, no torque is generated between take-up hub 152A and base 154A. When the device is assembled, top sheet 166A is assembled under tension to ensure efficient peeling from the first dose onwards. Consequently, nut 156A moves slightly upward along cam surface 155A, away from the perpendicular surface 111A of cam surface 155A. More specifically, as shown in the center figure, when the device is assembled, top sheet 166A is attached to take-up hub 152A, which rotates relative to base 154A, causing nut 156A to move upward along cam surface 155A. The compression spring 158A is deflected or slightly compressed relative to its uncompressed length, imparting a preload to the compression spring 158A. This preload ensures that the top sheet 166A of the first blister strip 160A has sufficient tension to allow it to be peeled from the bottom sheet 162A of the first blister strip 160A during the initial stages of the device's life. The dimensions of the compression spring 158A and the angle of the cam surface 155A should be configured to provide a minimum tension in the top sheet 166A of the first blister strip 160A that is greater than the maximum force required to peel the top sheet 166A of the first blister strip 160A from the bottom sheet 162A of the first blister strip 160A. In this assembled state, the combination of the compression spring 158A, nut 156A, and cam surface 155A provides a torque between the base 154A and the take-up hub 152A, which is counteracted by the tension in the top sheet 166A. As shown in the figure on the right, the tension in the top sheet 166A of the first blister strip 160A increases over the life of the inhaler device 100. As the tension in the top sheet 166A increases, the nut 156A moves further upward along the cam surface 155A, whereby the increase in tension in the top sheet 166A is balanced by the further deflection of the compression spring 158A.

[0175] The angle of each inclined surface 113A of cam surface 155A or slope are configured to keep the tension force of the sheet of top sheet 166A, 166B consistent during the device service life.As mentioned above, for guaranteeing the correct operation of inhaler device 100, top sheet 166A, 166B need be in consistent tension force.Usually, the angle of each inclined surface 113A of cam surface 155A or slope are selected to guarantee that nut 156A moves along the cam surface 155A of pedestal 154A in the operating procedure of inhaler device 100, and can not move and exceed or cross vertical surface 111A.In one embodiment, the inclined surface 113A of cam surface 155A extends with the angle between 35 degree to 55 degree with respect to the longitudinal axis of pedestal 154A.In one embodiment, the inclined surface 113A of cam surface 155A extends with the angle between 40 degree to 50 degree with respect to the longitudinal axis of pedestal 154A. In one embodiment, the inclined surface 113A of the cam surface 155A extends at an angle of approximately 45 degrees relative to the longitudinal axis of the base 154A, where "approximately" as used herein includes a three-degree tolerance. In one embodiment, the slope of the inclined surface 113A of the cam surface 155A is between 0.70 and 1.0. In one embodiment, the slope of the inclined surface 113A of the cam surface 155A is between 0.80 and 0.95. In another embodiment, the slope of the inclined surface 113A of the cam surface 155A is between 0.7 and 1.4. In another embodiment, the slope of the inclined surface 113A of the cam surface 155A is between 1.0 and 1.4. The slope of the inclined surface 113A of the cam surface 155A can be constant over the length of the inclined surface, or can vary over the length of the inclined surface.

[0176] The radial width of the inclined surfaces 113A of the cam surface 155A is configured to optimize the amount of friction between the nut 156A and the cam surface 155A. Typically, a larger radial width of the inclined surfaces 113A of the cam surface 155A results in increased friction between the components, while a smaller radial width of the inclined surfaces 113A of the cam surface 155A may cause the nut 156A to undesirably disengage from the cam surface 155A. In one embodiment, the radial width of each inclined surface 113A of the cam surface 155A is between 1 mm and 3 mm. In one embodiment, the radial width of each inclined surface 113A of the cam surface 155A is between 1.5 mm and 2.5 mm. In one embodiment, the radial width of each inclined surface 113A of the cam surface 155A is approximately 2 mm, where "approximately" as used herein includes a tolerance of 0.2 mm.

[0177] Compared with the consistent tensioning mechanism that adopts torsion spring to keep the tension force of sheet, in tensioning mechanism 151A, use compression spring 158A to reduce cost and environmental impact of inhaler device 100, and can also bring the simpler assembling and / or manufacturing of inhaler device 100.Especially, for example, compression spring 158A does not need hook or supporting leg (and this hook or supporting leg need to be formed at the end of torsion spring).Owing to need not be used for the supporting leg that engages with holding structure, so compression spring 158A is more easily manufactured and / or assembles than torsion spring.In addition, compared with the mechanism that utilizes torsion spring, compression spring 158A is considered to and produces more axial symmetry and the torque of balance on winding hub 152A, makes that the winding hub according to an embodiment of the present invention can not depart from along axis, and this departure can cause the top sheet of blister strip to move and tangle or drag axially when winding the winding hub.

[0178] One of ordinary skill in the art will appreciate that the relative sizes and / or arrangements of the various components in the tensioning mechanism 151A may vary. Figures 14A-14E The relative sizes and / or arrangements of the various components are shown in the embodiments. Variations in the relative sizes and / or arrangements of the various components can result in mechanisms with varying mechanical properties due to differences in properties such as contact radius, cam surface slope, and compression spring specifications. Variations in the relative sizes and / or arrangements of the various components provide alternatives that may be desirable in some applications, depending on factors such as space requirements and manufacturing or assembly methods.

[0179] For example, Figure 15A and Figure 15BAnother embodiment of a tensioning mechanism 1551 is shown, having relative dimensions different from those of tensioning mechanism 151A. Tensioning mechanism 1551 includes a hub 1552, a base 1554 having a cam surface 1555 integrally formed thereon or fixed thereto, a nut 1556, a shaft 1557, and a compression spring 1558. The base 1554 has a cam surface 1555 integrally formed thereon or fixed thereto, and the compression spring 1558 extends between or is disposed between the nut 1556 and one end of the take-up hub 1552 spaced from the base 1554. The take-up hub 1552 is axially restrained relative to the base 1554 by a clamp or retaining structure 1549 disposed between the shaft 1557 and the take-up hub 1552. The operation of tensioning mechanism 1551 is identical to that of tensioning mechanism 151A described above, but in this embodiment, the diameter of cam surface 1555 on base 1554 is larger than the diameter of compression spring 1558. In other words, cam surface 1555 has a first outer diameter OD1, and compression spring 1558 has a second outer diameter OD2, the first outer diameter being larger than the second outer diameter. This arrangement can result in different mechanical properties for tensioning mechanism 1551 due to differences in contact radius, cam surface slope, and compression spring gauge.

[0180] As another example, Figure 16A and Figure 16BAnother embodiment of a tensioning mechanism 1651 is shown, wherein the components of tensioning mechanism 1651 are arranged differently from those of tensioning mechanism 151A. Tensioning mechanism 1651 includes a hub 1652, a base 1654, a nut 1656, a shaft 1657, and a compression spring 1658. The take-up hub 1652 is axially restrained relative to the base 1654 by a clamp or retaining structure 1649 disposed between the shaft 1657 and the take-up hub 1652. Tensioning mechanism 1651 provides functionality similar to that of tensioning mechanism 151A described above, but in this embodiment, a cam surface 1655 is integrally formed on or fixed to the inner circumferential surface of the take-up hub 1652. To interact with the cam surface 1655, the nut 1656 includes a plurality of outwardly extending ribs 1619 that protrude or extend radially outward from the outer circumferential surface of the nut 1656. A compression spring 1658 extends or is disposed between the nut 1656 and the base 1654 and biases the nut 1656 upwardly into the cam surface 1655. Furthermore, in this embodiment, the nut 1656 is rotationally locked to the base 1654 and the nut 1656 is only permitted to move axially relative to the base 1654. In other words, the nut 1656 is not permitted to rotate relative to the base 1654. The nut 1656 is rotationally locked to the base 1654 by a spline connection (not shown) that includes an inwardly extending rib that projects or extends radially outwardly from the inner circumferential surface of the nut 1656 and is received within an axial groove of the shaft 1657, similar to the embodiment of the present invention. Figure 14D The inwardly extending ribs are allowed to slide or move axially along the axial grooves, so that the nut 1656 is allowed to slide or move axially relative to the shaft 1657 and the base 1654 attached thereto, but the inwardly extending ribs do not allow the nut 1656 to rotate relative to the shaft 1657 and the base 1654.

[0181] The interaction between the cam surface 1655, the nut 1656, and the compression spring 1658 performs the same function as the cam surface 155A, the nut 156A, and the compression spring 158A, thereby providing a constant drive tension for the first blister strip 160A throughout the entire strip length. As the tension along the top sheet 166A increases, the take-up hub 1652 rotates relative to the base 1654 to reduce the tension along the top sheet 166A.

[0182] When the base 1654 rotates with the top sheet take-up gear (e.g., the first top sheet take-up gear 150A), the nut 1656 and the take-up hub 1652 also rotate in the same direction as the base 1654 due to the interaction between the nut 1656 with the compression spring 1658 and the cam surface 1655 of the take-up hub 1652. Furthermore, relative rotation is permitted between the take-up hub 1652 and the base 1654. More specifically, when sufficient torque is applied between the take-up hub 1652 and the base 1654, the take-up hub 1652 will rotate relative to the base 1654. Since the take-up hub 1652 is permitted to rotate relative to the base 1654 in a direction that will reduce the tension in the top sheet (e.g., the top sheet 166A), this relative rotation stabilizes or balances the tension in the top sheet through the deflection of the compression spring 1658. Thus, the tensioning mechanism 1651 acts as a torsion or torque limiter between the take-up hub 1652 and the base 1654 to control the tension in the top sheet of a blister strip, such as the first blister strip 160A.

[0183] As the tension on the top sheet of the blister strip increases, the torque applied by the top sheet to the take-up hub 1652 also increases. However, the torque does not continue to increase. Instead, the take-up hub 1652 begins to rotate relative to the base 1654, and the nut 1656 moves helically downward along the cam surface 1655 of the take-up hub 1652, thereby compressing the compression spring 1658. More specifically, as the take-up hub 1652 begins to rotate due to the increased tension on the top sheet of the blister strip, the outwardly extending ribs 1619 of the nut 1656 move along the inclined surface of the cam surface 1655 toward the compression spring 1658. As the nut 1656 presses against the compression spring 1658, the compression spring 1658 is compressed. Because the inwardly extending ribs of the nut 1656 are allowed to move axially within the axial slots of the shaft 1657, the nut 1656 moves axially relative to the base 1654. Thus, rotation of the take-up hub 1652 relative to the base 1654 causes the nut 1656 to move axially downward relative to the upper surface of the take-up hub 1652 toward the base 1654, and further axial movement of the nut 1656 axially compresses the compression spring 1658. The nut 1656 converts the axial force of the compression spring 1658 into a torque applied to the take-up hub 1652. The combination of the compression spring 1658, the nut 1656, and the cam surface 1655 thus provides a torque that counteracts the relative rotation between the take-up hub 1652 and the base 1654, thereby serving to maintain consistent tension in the top sheet of the blister strip.

[0184] As another example, Figure 17A and Figure 17BAnother embodiment of a tensioning mechanism 1751 is shown, wherein the components of tensioning mechanism 1751 are arranged differently from those of tensioning mechanism 151A. Tensioning mechanism 1751 includes a hub 1752, a base 1754 having a cam surface 1755 integrally formed thereon or fixed thereto, a nut 1756, a shaft 1757, and a compression spring 1758. The take-up hub 1752 is axially restrained relative to the base 1754 by a clamp or retaining structure 1749 disposed between the shaft 1757 and the take-up hub 1752. Tensioning mechanism 1751 provides the same functionality as tensioning mechanism 151A described above, but is implemented differently. In this embodiment, a compression spring 1758 extends or is disposed between the nut 1756 and the base 1754 and biases the nut 1756 upward into the cam surface 1755.

[0185] The cam surface 1755, nut 1756, and compression spring 1758 function in the same manner as the cam surface 155A, nut 156A, and compression spring 158A to provide a constant drive tension to the blister strip (e.g., first blister strip 160A) over the entire strip length. Increased tension along the top sheet of the blister strip (e.g., top sheet 166A) causes the take-up hub 1752 to rotate relative to the base 1754 to reduce the tension along the top sheet of the blister strip.

[0186] When the base 1754 rotates with the top sheet take-up gear (e.g., the first top sheet take-up gear 150A), the nut 1756 and the take-up hub 1752 also rotate in the same direction as the base 1754 due to the interaction between the nut 1756 having the compression spring 1758 and the cam surface 1755. Furthermore, relative rotation is permitted between the take-up hub 1752 and the base 1754. More specifically, when sufficient torque is applied between the take-up hub 1752 and the base 1754, the take-up hub 1752 will rotate relative to the base 1754. Since the take-up hub 1752 is permitted to rotate relative to the base 1754 in a direction that will reduce the tension in the top sheet (e.g., the top sheet 166A), this relative rotation stabilizes or balances the tension in the top sheet through the deflection of the compression spring 1758. Thus, the tensioning mechanism 1751 acts as a torsion or torque limiter between the take-up hub 1752 and the base 1754 to control the tension in the top sheet of a blister strip, such as the first blister strip 160A.

[0187] As the tension on the top sheet of the blister strip increases, the torque applied by the top sheet to the take-up hub 1752 also increases. However, the torque does not continue to increase. Instead, the take-up hub 1752 begins to rotate relative to the base 1754, and the nut 1756 moves helically downward along the cam surface 1755, thereby compressing the compression spring 1758. More specifically, as the take-up hub 1752 begins to rotate due to the increased tension on the top sheet of the blister strip, the inwardly extending ribs of the nut 1756 move downward along the inclined surface of the cam surface 1755 toward the compression spring 1758. As the nut 1756 presses against the compression spring 1758, the compression spring 1758 is compressed. Because the outwardly extending ribs of the nut 1756 allow axial movement within the axial grooves of the take-up hub 1752 (similar to the splined connection arrangement between the nut 156A and the take-up hub 152A), the nut 1756 moves axially relative to the base 1754. Thus, rotation of the take-up hub 1752 relative to the base 1754 causes the nut 1756 to move axially downward relative to the top surface or wall of the take-up hub 1752 toward the base 1754, and further axial movement of the nut 1756 toward the compression spring 1758 axially compresses the compression spring 1758. The nut 1756 converts the axial force of the compression spring 1758 into a torque applied to the take-up hub 1752. The combination of the compression spring 1758, the nut 1756, and the cam surface 1755 thus provides a torque to counteract the relative rotation between the take-up hub 1752 and the base 1754, thereby serving to maintain consistent tension in the top sheet of the blister strip.

[0188] Figures 18-20 Another embodiment of a tensioning mechanism or tensioning subassembly that can be used in an inhaler device 100 is shown. Similar to the tensioning mechanism 151A described above, the tensioning mechanism 1851 is used to peel off the top sheet 166A from the blister strip 160A in a manner that maintains a consistent peeling distance or amount during the service life of the device. The tensioning mechanism 1851 is also used to maintain the sheet tension of the top sheet 166A during the service life of the device. The tensioning mechanism 1851 is associated with a top sheet winding gear (e.g., the first top sheet winding gear 150A) for winding the top sheet 166A of the blister strip 160A. It should be understood that in the inhaler device 100, each of the first tensioning mechanism 151A and the second tensioning mechanism 151B can be replaced by the tensioning mechanism 1851 without departing from the scope of this disclosure.

[0189] In this embodiment, the top sheet take-up gear is integrally formed with or fixed to the take-up hub 1852 so as to rotate as a single unit. The top sheet 166A of the blister strip 160A is fixed or attached to the take-up hub 1852 by hooks 1853 so that when the first take-up hub 1852 rotates, the top sheet 166A of the blister strip 160A is wrapped around the take-up hub 1852. As described above, as the take-up hub 1852 completes multiple rotations during the life of the inhaler device 100, the top sheet 166A of the blister strip 160A is wrapped around itself multiple times, causing the radial position of the top sheet 166A on the take-up hub 1852 to increase.

[0190] Tensioning mechanism 1851 comprises sliding member 1861 and at least one compression spring 1858 that is attached to sliding member 1861.Tensioning mechanism 1851 is arranged between winding hub 1852 and the positioning reel (for example first positioning reel 131A), and is configured to regulate the length of top sheet 166A between winding hub 1852 and the first positioning reel 131A, to keep the consistent of the tension force of top sheet 166A, thereby compensate winding effect and component tolerance.As will be described in more detail in this article, tensioning mechanism 1851 applies non-parallel force to the part of top sheet 166A by compression spring 1858.Tensioning mechanism 1851 is coupled on the housing 102 of inhaler device 100, so that allow sliding member 1861 to move axially relative to housing 102 along predetermined path 1863. The slider 1861 is configured to receive and guide a middle portion of the top sheet 166A that is disposed between the first positioning spool 131A and the take-up hub 1852. Increased tension along the top sheet 166A causes the slider to move axially along a predetermined path 1863, and the axial movement of the slider 1861 axially compresses the compression spring 1858 to reduce the tension along the top sheet 166A.

[0191] More specifically, the slider 1861 is coupled to the housing 102 of the inhaler device 100 such that the slider 1861 is movable relative to the housing 102 along a predetermined path 1863. Figure 19B As best shown, predetermined path 1863 is formed by the groove of the inner surface of housing 102, and this predetermined path 1863 is linear predetermined path.In another embodiment (not shown), predetermined path 1863 can be nonlinear.For example, predetermined path 1863 can be a curved predetermined path, to allow the space efficiency of optimization in inhaler device 100 and / or to adjust the mechanical performance of tensioning mechanism 1851 during the service life of device.

[0192] Compression spring 1858 is configured to act between slider 1861 and housing 102, providing a force acting in the direction of predetermined path 1863. A first end 1807 of compression spring 1858 is attached or fixed to slider 1861, and a second end 1809 of compression spring 1858 is attached or fixed to housing 102. The top sheet 166A of blister strip 160A travels from first positioning reel 131A, passes around slider 1861, and is attached to take-up hub 1852 as described above. The axial force of compression spring 1858 urges slider 1861 in a direction away from first positioning reel 131A and take-up hub 1852. In other words, compression spring 1858 is biased to urge slider 1861 away from each of first positioning reel 131A and take-up hub 1852. Thus, the length of the top sheet 166A between the first positioning reel 131A and the take-up hub 1852 is affected by the position of the slider 1861 within the available travel of the slider 1861 along the predetermined path 1863. Figure 19A , when the compression spring 1858 is slightly relaxed and at a longer length, the slider 1861 moves further away from each of the first positioning reel 131A and the take-up hub 1852, thereby causing the top sheet 166A to extend a greater or longer length between the first positioning reel 131A and the take-up hub 1852. Conversely, referring to Figure 19B When the compression spring 1858 is compressed and at a shorter length, the slider 1861 is spaced closer to the first positioning reel 131A and the take-up hub 1852, thereby causing the top sheet 166A to extend a shorter length between the first positioning reel 131A and the take-up hub 1852.

[0193] During each dose administration, the first positioning reel 131A rotates in a first direction (e.g., clockwise) with its positioning gear (e.g., first positioning gear 130A), and the take-up hub 1852 rotates in a second, opposite direction (e.g., counterclockwise) with its top sheet take-up gear (e.g., top sheet take-up gear 150A as described above). When the first positioning reel 131A and the take-up hub 1852 are driven in opposite directions, the top sheet 166A is pulled around the slider 1861, peeling it away from the bottom sheet 162A, which moves clockwise with the first positioning reel 131A. Due to the wrap-around effect, the radial position of the top sheet 166A of the blister strip 160A increases as the take-up hub 1852 rotates. Due to this increase in radial position, the take-up hub 1852 is required to peel a longer length of the top sheet 166A, and due to the change in the peeling angle between the top sheet 166A of the blister strip 160A and the bottom sheet 162A of the first blister strip 160A, the tension in the top sheet 166A increases. As the take-up hub 1852 begins to pull the top sheet 166A further, the reaction force at the peeling edge increases, causing the tension in the top sheet 166A to increase. The tensioning mechanism 1851 ensures that the same amount of top sheet 166A of the blister strip 160A is peeled each time. To achieve this, the increased tension in the top sheet 166A pulls or moves the slider 1861 toward the positioning reel 131, thereby resisting the force from the compression spring 1858. As the slider 1861 moves toward the first positioning reel 131A, the length of the top sheet 166A extending between the first positioning reel 131A and the take-up hub 1852 will decrease, thereby reducing the reaction force at the peeling edge. Figure 19A and Figure 19B 166A) compresses the compression spring 1858 in the axial direction to reduce the tension along the top sheet 166A, and the axial compression of the compression spring 1858 moves the slide 1861 closer to each of the first positioning reel 131A and the take-up hub 1852. When the force from the compression spring 1858 balances the tension in the top sheet, the tensioning mechanism is in a stable state, and the tension in the top sheet balances the reaction force at the peeling edge. In this way, the tension in the top sheet 166A is maintained at a relatively consistent level by the tensioning mechanism throughout the service life of the device. The tensioning mechanism 1851 stabilizes or balances the tension in the top sheet 166A through compression of the compression spring 1858 and movement of the slide 1861.

[0194] Figure 20 The performance characteristics of the tensioning mechanism 1851 are shown. Figure 20The graph of FIG. 1 shows the increase in radial position of the top sheet 166A over the life of the device, as well as the cumulative length compensation of the top sheet 166A achieved by the movement of the slider 1861. The graph also shows the approximate tension in the top sheet 166A over the life of the device. Due to the stiffness of the compression spring 1858, the tension in the top sheet may gradually increase, but as shown in the figure, the tension in the top sheet remains substantially consistent or constant over the life of the device.

[0195] Those skilled in the art will appreciate that the relative sizes and / or arrangements of the various components of the tensioning mechanism 1851 may vary. Figures 18-20 In the embodiment shown, different.The different performance characteristics of tensioning mechanism 1851 can be realized through different component geometries, positioning and compression spring specifications.For example, a compression spring with longer entity height and lower rigidity can be used.This compression spring can take up more space in the inhaler device, but can produce the tension force of more consistent top sheet in the whole service life of device.According to factors such as space requirement, manufacture or assembly method, the relative size of various parts and / or the variation of arrangement provide the alternative selection that may need in some applications.

[0196] When the compression spring 1858 is in its initial assembled state within the inhaler device 100 and the top sheet 166A is attached to the take-up hub 1852, the compression spring 1858 is deflected or slightly compressed relative to its uncompressed length, causing the compression spring 1858 to apply a preload force. The preload force ensures that there is sufficient tension in the top sheet 166A of the blister strip 160A to peel it from the bottom sheet 162A of the blister strip 160A during the initial stages of the device's service life. The dimensions of the compression spring 1858 and the surrounding geometry should be configured to provide a minimum tension in the top sheet 166A of the 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 blister strip 160A.

[0197] exist Figures 18-20 In the illustrated embodiment, compression spring 1858 is a single spring. However, compression spring 1858 may include more than one spring. For example, in another embodiment, compression spring 1858 includes two springs used in parallel or coaxially. Using two compression springs in parallel or coaxially can allow the physical height of the spring to be reduced for the same combined stiffness, thereby reducing the physical size of the tensioning mechanism.

[0198] Furthermore, in another embodiment, one or more extension springs may be used in place of compression spring 1858. The extension springs are positioned relative to the slider so that axial movement of the slider stretches the extension springs axially toward first positioning reel 131A, reducing tension along the top sheet of the blister strip. For space efficiency, extension springs may be more suitable for some device layouts. Furthermore, in another embodiment, one or more torsion springs may be used in place of compression spring 1858. If extension or torsion springs are used in place of compression spring 1858, these springs act between the slider and the housing, providing a force that moves the slider away from the positioning gear (i.e., increases the length of the top sheet between the positioning gear and the take-up hub). Using torsion springs may make it more desirable for the slider to move along an arcuate path rather than a straight line, thereby maintaining the slider concentric with the axis of the torsion spring and maintaining more consistent operation.

[0199] Although Figures 18-20 In the embodiment shown, take-up hub 1852 is rotationally driven in the opposite direction from positioning gear 130A. However, in another embodiment, take-up hub 1852 can be rotationally driven in the same direction as positioning gear 130A by adding an idler gear (not shown) disposed between positioning gear 130A and winding gear 150A. When positioning gear 130A and take-up hub 1852 both rotate in the same direction (i.e., the first direction or clockwise), top sheet 166A is wound around take-up hub 1852 in the first direction, which causes the angle of top sheet 166A to more closely match the travel angle of slider 1861. Therefore, the same amount of slider travel results in a greater change in the length of top sheet 166A. The reduced total travel of slider 1861 results in a smaller physical size of the tensioning mechanism and / or more consistent sheet tension.

[0200] In contrast to tensioning mechanism 151A, the components of tensioning mechanism 1851 are not housed or contained within take-up hub 1852. The non-enclosed or exposed nature of slider 1861 and compression spring 1858 allows for a range of spring sizes and specifications to be incorporated without changing the geometry or dimensions of take-up hub 1852, which may be useful for optimizing the tensioning mechanism for different blister strip designs and specifications. The non-enclosed or exposed nature of slider 1861 and compression spring 1858 also allows for better verification of the success of the assembly process and the status of the tensioning mechanism during assembly, thereby reducing the risk of undetected assembly errors.

[0201] Figure 21-23BShown is another embodiment of the tensioning mechanism or tensioning subassembly 2151 that can be used for inhaler device 100.Be similar to above-mentioned tensioning mechanism, tensioning mechanism 2151 is used for peeling off top sheet 166A from blister strip 160A, to keep consistent peeling distance or peeling amount during the device service life.Tensioning mechanism 2151 is also used for keeping the sheet tension of top sheet 166A during the device service life.Tensioning mechanism 2151 is associated with top sheet winding gear (for example first top sheet winding gear 150A), is used for winding the top sheet 166A of blister strip 160A.Should be appreciated that in inhaler device 100, each in the first tensioning mechanism 151A and the second tensioning mechanism 151B can be replaced by tensioning mechanism 2151, without departing from the scope of this disclosure.

[0202] In this embodiment, the top sheet take-up gear is integrally formed with or fixed to the take-up hub 2152 so as to rotate as a single unit. The top sheet 166A of the blister strip 160A is fixed or attached to the take-up hub 2152 via a hook 2153 so that the top sheet 166A of the blister strip 160A is wound around it as the take-up hub 2152 rotates. As described above, as the take-up hub 2152 completes multiple rotations during the life of the inhaler device 100, the top sheet 166A of the blister strip 160A is wound around itself multiple times, causing the radial position of the top sheet 166A on the take-up hub 2152 to increase.

[0203] The tensioning mechanism 2151 includes a pin 2165 (the pin 2165 is fixed to and extends from an inner surface, wall, or component of the housing 102), a bracket 2101, and at least one tension spring 2158 attached to the bracket 2101. The tensioning mechanism 2151 is configured to adjust the length of the top sheet 166A between the take-up hub 2152 and the first positioning spool 131A to maintain consistent tension on the top sheet 166A, thereby compensating for winding effects and component tolerances. As will be described in more detail herein, the tensioning mechanism 2151 maintains consistent tension on the top sheet 166A by allowing the take-up hub 2152 (and the top sheet 166A mounted thereon) to move by the tension spring 2158, wherein the tension spring 2158 is biased in a direction generally away from the take-up hub 2152 and the top sheet 166A wound thereon. The take-up hub 2152 is attached to the housing 102 of the inhaler device 100 so as to allow the take-up hub 2152 to move relative to the housing 102 along a predetermined path 2163. The pin 2165 is configured to receive and guide a middle portion of the top sheet 166A, which is disposed between the first positioning spool 131A and the take-up hub 2152. Increased tension along the top sheet 166A causes the take-up hub 2152 to move along the predetermined path 2163, and the movement of the take-up hub 2152 axially extends or stretches the tension spring 2158 to reduce the tension along the top sheet 166A.

[0204] 131A. More specifically, winding hub 2152 is coupled on the housing 102 of inhaler device 100 so that winding hub 2152 can move relative to housing 102 along predetermined path 2163.Predetermined path 2163 is formed by the curved groove of the inner surface of housing 102. Winding hub 2152 extends through the curved groove that limits predetermined path 2163. The curved groove that forms predetermined path 2163 is concentric with the axis of rotation of the first positioning reel 131A so that winding hub 2152 advances in the arc that is concentric with the axis of rotation of the first positioning reel 131A. Therefore, along with winding hub 2152 moves along predetermined path 2163, winding gear 150A will keep engaging with positioning gear 130A.

[0205] Pin 2165 extends radially from the inner surface of housing 102 and is secured to the housing. Top sheet 166A travels from first positioning reel 131A, around pin 2165, and then attaches to take-up hub 2152. Pin 2165 is positioned near one end of a curved slot that forms predetermined path 2163. As will be described in greater detail below, pin 2165 is positioned within housing 102 such that movement of take-up hub 2152 causes a change in the length of top sheet 166A between take-up hub 2152 and first positioning reel 131A.

[0206] The take-up hub 2152 is mechanically connected or coupled to the housing 102 via the bracket 2101. The take-up hub 2152 is coupled to the bracket 2101 such that when the take-up hub 2152 is rotationally driven to wind the top sheet 166A, the take-up hub 2152 rotates relative to the bracket 2101. Similarly, the positioning gear 130A is coupled to the bracket 2101 such that when the positioning gear 130A is rotationally driven to advance the blister strip 160A, the positioning gear 130A rotates relative to the bracket 2101. The bracket 2101 has a first end 2103 (e.g., Figure 21 as shown) and the second end 2105 (as shown Figure 22 130A). The first end 2103 and the second end 2105 are connected to the first positioning spool 131A in a manner that allows the bracket 2101 to rotate relative to the first positioning spool 131A. Therefore, when the bracket 2101 rotates relative to the housing 102, the center of the take-up hub 2152 moves within a predetermined path 2163 of the curved slot of the housing 102. The bracket 2101 is allowed to rotate relative to the housing 102, and when the take-up hub 2152 travels within the predetermined path 2163, the bracket 2101 rotates or pivots about the positioning gear 130A.

[0207] The tension spring 2158 is configured to act between the bracket 2101 and the housing 102, providing a force that pulls the take-up hub 2152 toward one end of the predetermined path 2163 of the curved slot of the housing 102, away from the pin 2165. Figure 22 As shown, a first end 2107 of the tension spring 2158 is attached or fixed to the housing 102 and a second end 2109 of the tension spring 2158 is attached or fixed to the bracket 2101. The top sheet 166A of the blister strip 160A originates from the first positioning reel 131A, passes around the pin 2165, and is attached to the take-up hub 2152 as described above. The axial force of the tension spring 2158 pulls the take-up hub 2152 in a direction away from the pin 2165. In other words, the tension spring 2158 is biased to position the take-up hub 2152 at the end of the curved slot opposite the pin 2165. Therefore, the length of the top sheet 166A between the first positioning reel 131A and the take-up hub 2152 is affected by the position of the take-up hub 2152 within the available travel of the take-up hub 2152 along the predetermined path 2163. Figure 23A , when the tension spring 2158 is compressed and at a shorter length, the take-up hub 2152 is further away from the pin 2165, thereby causing the length of the top sheet 166A between the first positioning reel 131A and the take-up hub 2152 to be greater or longer. Figure 23B When the tension spring 2158 is stretched and at a longer length, the take-up hub 2152 is closer to the pin 2165, whereby the length of the top sheet 166A between the first positioning reel 131A and the take-up hub 2152 is shorter.

[0208] During each dose administration, as described above, the first positioning reel 131A rotates in a first direction (i.e., clockwise) along with the positioning gear 130A, and the take-up hub 2152 rotates in a second, opposite direction (i.e., counterclockwise) along with the top sheet take-up gear 150A. As the first positioning reel 131A and the take-up hub 2152 are driven in opposite directions, the top sheet 166A is pulled around the pin 2165, peeling away from the bottom sheet 162A, which moves clockwise with the first positioning reel 131A. Due to the aforementioned wrapping effect, the radial position of the top sheet 166A of the blister strip 160A increases as the take-up hub 2152 rotates. Due to this increased radial position, the take-up hub 2152 is required to peel a longer length of the top sheet 166A. Due to the change in the peel angle between the top sheet 166A and the bottom sheet 162A of the blister strip 160A, the tension in the top sheet 166A increases. As the take-up hub 2152 begins to pull further on the top sheet 166A, the reaction force at the peel edge increases, thereby increasing the tension in the top sheet 166A. The tensioning mechanism 2151 ensures that the same amount of top sheet 166A of the blister strip 160A is peeled off for each dose. The increased tension in the top sheet 166A acts to counteract the force from the tension spring 2158, pulling or moving the take-up hub 2152 along a predetermined path 2163 defined by the curved slot of the housing 102, toward the pin 2165. As the take-up hub 2152 moves along the predetermined path 2163, the bracket 2101 rotates relative to the housing 102. As the take-up hub 2152 moves toward the first positioning reel 131A and the pin 2165, the length of the top sheet 166A between the first positioning reel 131A and the take-up hub 2152 will decrease, thereby reducing the reaction force at the peel edge. Figure 23A and Figure 23B , showing the movement of the take-up hub 2152, the rotation of the bracket 2101, and the deformation of the tension spring 2158. The movement of the take-up hub 2152 (due to the increased tension in the top sheet 166A) extends or stretches the tension spring 2158 axially to reduce the tension along the top sheet 166A, and the take-up hub 2152 moves closer to each of the first positioning spool 131A and the pin 2165. When the force from the tension spring 2158 balances the tension in the top sheet, and the tension in the top sheet balances the reaction force at the peeling edge, the tensioning mechanism is in a stable state. In this way, the tension in the top sheet 166A is maintained at a relatively consistent level by the tensioning mechanism throughout the life of the device. The tensioning mechanism 2151 stabilizes or balances the tension in the top sheet 166A through the extension of the tension spring 2158 and the movement of the take-up hub 2152.

[0209] When the tension spring 2158 is in the initial assembly state within the inhaler device 100 and the top sheet 166A is attached to the take-up hub 2152, the tension spring 2158 is deflected or slightly extended relative to its compressed length, causing the tension spring 2158 to apply a preload force. The preload force ensures that there is a sufficiently high tension in the top sheet 166A of the blister strip 160A to peel the top sheet 166A from the bottom sheet 162A of the blister strip 160A at the beginning of the device's service life. The dimensions of the tension spring 2158 and the surrounding geometry should be configured to provide a minimum tension in the top sheet 166A of the blister strip 160A that is higher than the maximum force required to peel the top sheet 166A of the blister strip 160A from the bottom sheet 162A of the blister strip 160A.

[0210] As in Figure 22 As can be best seen in the perspective view of FIG, the tension spring 2158 is aligned with or disposed along the centerline of the take-up hub 2152, and therefore aligned with or disposed along the centerline of the top sheet 166A wound thereon. This alignment between the tension spring 2158 and the centerline of the top sheet 166A minimizes torque on the bracket 2101 as it rotates with movement of the take-up hub 2152.

[0211] In contrast to tensioning mechanism 151A, the components of tensioning mechanism 2151 are not housed or contained within take-up hub 2152. The non-enclosed or exposed nature of bracket 2101 and tension spring 2158 allows for incorporation of a range of spring sizes and specifications without changing the geometry or dimensions of take-up hub 2152, which may be useful for optimizing the tensioning mechanism for different blister strip designs and specifications. The non-enclosed or exposed nature of bracket 2101 and tension spring 2158 also allows for improved verification of the success of the assembly process and the status of the tensioning mechanism during assembly, thereby reducing the risk of undetected assembly errors.

[0212] One of ordinary skill in the art will appreciate that the relative sizes and / or arrangements of the various components of the tensioning mechanism 2151 may vary. Figure 21-23B Variations in the relative sizes and / or arrangements of the various components provide alternatives that may be desirable in some applications, depending on factors such as space requirements, manufacturing or assembly methods, and the like.

[0213] Figure 24 and Figure 25Another embodiment of a tensioning mechanism or tensioning subassembly 2451 that can be used in an inhaler device 100 is shown. The function of tensioning mechanism 2451 is similar to that of tensioning mechanism 2151, but tensioning mechanism 2451 utilizes two torsion springs 2458, 2458A (instead of tension spring 2158 and bracket 2101). First torsion spring 2458 is positioned to interact with a first side of winding hub 2452, and second torsion spring 2458A is positioned to interact with a second, opposite side of winding hub 2452. It is believed that utilizing two torsion springs acting on opposite sides of winding hub 2452 can provide better positional stability for winding hub 2452; however, in another embodiment thereof, tensioning mechanism 2451 can only include a single torsion spring acting on a single side of winding hub 2452. Torsion springs 2458, 2458A function similarly to tension spring 2158 and provide a force to bias winding hub 2452 away from pin 2465. Furthermore, in this embodiment, the winding hub 2452 is constrained within two arcuate slots 2433, 2433A in the housing 102, rather than being constrained by a bracket. Although the functional principle is similar to that of the tensioning mechanism 2151, the tensioning mechanism 2451 has different physical dimensions than the tensioning mechanism 2151 and has different advantages in terms of assembly complexity, robustness, cost, etc.

[0214] Tensioning mechanism 2451 comprises a plurality of parts identical with the parts of tensioning mechanism 2151, therefore will no longer be described in detail.More specifically, winding hub 2452 is identical with winding hub 2152, and pin 2465 is identical with pin 2165, and predetermined path 2463 is identical with predetermined path 2163. Winding hub 2452 is coupled to the housing 102 of inhaler device 100, so that allow winding hub 2452 to move relative to housing 102 along predetermined path 2463.Pin 2465 is configured to receive and guide the center portion of top sheet 166A, and this center portion is arranged between first positioning reel 131A and winding hub 2452.The tension force that increases along top sheet 166A can make winding hub 2452 move along predetermined path 2463.

[0215] The first leg 2407, 2407A of each torsion spring 2458, 2458A is fixed to the inner surface of the housing 102, and the second leg 2409, 2409A of each torsion spring 2458, 2458A is coupled to the take-up hub 2452 for movement with the take-up hub 2452 along a predetermined path 2463 defined by the curved slot. The body of each torsion spring 2458, 2458A is concentrically disposed with the axis of rotation of the positioning reel 131. Each torsion spring 2458, 2458A is biased to position the take-up hub 2452 at the end of the predetermined path 2463 defined by the curved slot, opposite the pin 2465. Movement of the take-up hub 2452 toward the pin 2465 causes the torsion spring 2458, 2458A to twist, thereby reducing tension along the top sheet 166A of the blister strip 160A, as will be described in greater detail below.

[0216] Each torsion spring 2458, 2458A is configured to act between the take-up hub 2452 and the housing 102, providing a force that pulls the take-up hub 2452 toward the end of the predetermined path 2463 of the curved slot of the housing 102, away from the pin 2465. More specifically, as Figure 24 As shown, the first leg 2407 of the first torsion spring 2458 is attached or fixed to the housing 102, and the second leg 2409 of the first torsion spring 2458 is attached or fixed to the take-up hub 2452. Figure 25 As shown, the first leg 2407A of the second torsion spring 2458A is attached or fixed to the housing 102, and the second leg 2409A of the second torsion spring 2458A is attached or fixed to the take-up hub 2452. The top sheet 166A of the blister strip 160A travels from the first positioning reel 131A, around the pin 2465, and is attached to the take-up hub 2452. The force of the torsion springs 2458, 2458A pulls the take-up hub 2452 away from the pin 2465. In other words, the torsion springs 2458, 2458A are biased to position the take-up hub 2452 at the end of the curved slot opposite the pin 2465. As a result, the length of the top sheet 166A between the first positioning reel 131A and the take-up hub 2452 is affected by the position of the take-up hub 2452 within its available travel along the predetermined path 2463.

[0217] During each dose administration, as described above, the first positioning reel 131A rotates in a first direction (i.e., clockwise) with the positioning gear 130A, and the take-up hub 2452 rotates in a second, opposite direction (i.e., counterclockwise) with the top sheet take-up gear 150A. When the first positioning reel 131A and the take-up hub 2452 are driven in opposite directions, the top sheet 166A is pulled around the pin 2465, peeling the top sheet 166A from the bottom sheet 162A, which moves clockwise with the first positioning reel 131A. Due to the wrapping effect, the radial position of the top sheet 166A of the blister strip 160A increases as the take-up hub 2452 rotates. Due to this increased radial position, the take-up hub 2452 is required to peel a longer length of the top sheet 166A, and due to the change in the peel angle between the top sheet 166A of the blister strip 160A and the bottom sheet 162A of the blister strip 160A, the tension in the top sheet 166A increases. As the take-up hub 2452 begins to pull further on the top sheet 166A, the reaction force at the peel edge increases, thereby increasing the tension in the top sheet 166A. The tensioning mechanism 2451 ensures that the same amount of top sheet 166A of the blister strip 160A is peeled each time. The increased tension in the top sheet 166A acts to counteract the force from the torsion springs 2458, 2458A, pulling or moving the take-up hub 2452 along a predetermined path 2463 defined by the curved slot of the housing 102 toward the pin 2465. As the take-up hub 2452 moves toward the first positioning reel 131A and the pin 2465, the length of the top sheet 166A between the first positioning reel 131A and the first take-up hub 2452 decreases, thereby reducing the reaction force at the peeling edge. The movement of the take-up hub 2452 (due to the increased tension in the top sheet 166A) causes the torsion springs 2458, 2458A to twist, reducing the tension along the top sheet 166A, and the take-up hub 2452 moves closer to each of the first positioning reel 131A and the pin 2465. When the force from the torsion springs 2458, 2458A balances the tension in the top sheet, and the tension in the top sheet balances the reaction force at the peeling edge, the tensioning mechanism is in a stable state. In this way, the tension in the top sheet 166A is maintained at a relatively consistent level by the tensioning mechanism throughout the service life of the device. The tensioning mechanism 2451 stabilizes or balances the tension in the top sheet 166A by twisting the torsion springs 2458 , 2458A and moving the take-up hub 2452 .

[0218] Figures 26A-26NAnother embodiment of a tensioning mechanism 2651 is shown. The operation of tensioning mechanism 2651 is identical to that of tensioning mechanism 151A, but in this embodiment, the retaining structure that limits axial movement of the take-up hub relative to the base is a bayonet connection. Similar to tensioning mechanism 151A, tensioning mechanism 2651 includes a hub 2652, a base 2654, a nut 2656, a shaft 2657, and a compression spring 2658. The base 2654 has a cam surface 2655 integrally formed thereon or fixed thereto. The compression spring 2658 extends or is disposed between the nut 2656 and an end of the take-up hub 2652 spaced from the base 2654. The compression spring 2658 biases the nut 2656 downwardly toward the base 2654 into the cam surface 2655. The compression spring 2658 is disposed on the periphery of the shaft 2657 or around the shaft 2657 and is longitudinally or axially adjacent to the nut 2656. The take-up hub 2652 is disposed on the periphery of the nut 2656 and the compression spring 2658 or around the nut 2656 and the compression spring 2658. In other words, the take-up hub 2652 surrounds or encloses the nut 2656 and the compression spring 2658 housed therein.

[0219] The base 2654 is attached to or integrally formed with the first top sheet winding gear 2650 so as to rotate as a single component when the first top sheet winding gear 2650 is driven to rotate. For example, the base 2654 may include a plurality of gear teeth integrally formed with or fixed to the outer peripheral surface of the base 2654 to form the first top sheet winding gear 2650. The shaft 2657 extends from the base 2654 and is attached to or integrally formed with the base 2654 so as to rotate together with the base 2654. Therefore, when the first top sheet winding gear 2650 is driven to rotate, the shaft 2657, the base 2654, and the first top sheet winding gear 2650 rotate as a single component. The cam surface 2655 of the shaft 2657 includes alternating vertical surface 2611 portions and inclined surface 2613 portions. The vertical surface 2611 extends generally parallel to the longitudinal axis of the shaft 2657. In this embodiment, the cam surface 2655 includes a total of two vertical surfaces 2611 disposed at opposing positions on the shaft 2657, and two inclined surfaces 2613 disposed at opposing positions on the shaft 2657. The inclined surfaces 2613 extend helically around the shaft 2657.

[0220] The take-up hub 2652 is axially constrained relative to the base 2654 by a bayonet connection 2649 between the shaft 2657 and the take-up hub 2652. Although the bayonet connection 2649 is described and shown as being implemented in a tensioning mechanism 2651, which operates identically to the tensioning mechanism 151A, the bayonet connection 2649 may be similarly implemented in any of the tensioning mechanism embodiments described herein.

[0221] refer to Figure 26A and Figure 26B , the bayonet connection 2649 includes a male bayonet structure or radial extension 2667 that is connected to or integrally formed with the shaft 2657 and is therefore attached to the base 2654. The radial extension 2667 is a protrusion that extends radially outward from the outer surface of the shaft 2657. The bayonet connection 2649 also includes a female bayonet structure 2669 formed in the takeup hub 2652. The female bayonet structure 2669 includes an internal flange 2671 formed on the inner surface of the takeup hub 2652, and the internal flange 2671 has an axial groove 2675 formed therethrough. In the illustrated embodiment, a single male bayonet structure and a single female bayonet structure are used, although a larger number may be used. The internal flange 2671 is a planar protrusion that extends radially inward from the inner surface of the takeup hub 2652 to form an internal flange or ledge. In one embodiment, the inner flange 2671 extends around the entire inner diameter of the take-up hub 2652, except that it does not extend across the width of the axial slot 2675. The axial slot 2675 is configured to allow the radial extension 2667 to pass through the axial slot 2675. During assembly of the tensioning mechanism 2651, when the take-up hub 2652 is axially assembled or coupled to the base 2654, the radial extension 2667 and the axial slot 2675 are circumferentially or rotationally aligned, such that the radial extension 2667 passes through the axial slot 2675. During assembly of the tensioning mechanism 2651, the bayonet connection 2649 is in an open or unlocked state.

[0222] More specifically, the open or unlocked state of the bayonet connection 2649 is Figure 26C and Figure 26CC Shown in. Figure 26C shows a top view of the tensioning mechanism 2651 in an open or unlocked state, and Figure 26CC yes Figure 26C Cross-sectional view of . Figure 26CAs shown, radial extension 2667 and axial slot 2675 are aligned circumferentially or rotationally. Radial extension 2667 does not abut or contact inner flange 2671 because radial extension 2667 is disposed through axial slot 2675 of flange 2671. In the open or unlocked state, takeup hub 2652 is not axially constrained relative to base 2654. In other words, in the absence of a force applied thereto, compression spring 2658 will act to urge takeup hub 2652 axially away from base 2654 when bayonet connection 2649 is in the open or unlocked state.

[0223] The take-up hub 2652 is configured to rotate a certain amount relative to the base 2654 to axially lock the take-up hub 2652 and the base 2654 together, thereby resisting the compression spring load of the compression spring 2658. After the take-up hub 2652 is rotated a certain amount relative to the base 2654 to axially lock the take-up hub 2652 and the base 2654 together, the closed or locked state of the bayonet connection 2649 is as shown in FIG. Figure 26D and Figure 26DD shown. Figure 26D shows a top view of the tensioning mechanism 2651 in a closed or locked state, and Figure 26DD yes Figure 26D Cross-sectional view of . Figure 26D As shown, the radial extension 2667 and the axial groove 2675 are no longer aligned circumferentially or in the rotational direction. Figure 26DD As shown, the radial extension 2667 abuts against the top surface of the internal flange 2671. Although the compression spring 2658 pushes the take-up hub 2652, the take-up hub 2652 is axially restricted relative to the base 2654 in the closed or locked state because the internal flange 2671 acts as an axial stop and prevents axial movement of the take-up hub 2652. In the closed or locked state, the tensioning mechanism 2651 is a stable subassembly that can be installed in an inhaler device. Figures 26A-26N In the embodiment of the present invention, the take-up hub 2652 is configured to rotate approximately ninety degrees (90°) relative to the base 2654 to convert the bayonet connection 2649 from an open or unlocked state to a closed or locked state. However, this is merely exemplary, and other relative amounts of rotation may be utilized. For example, if the bayonet structure is able to be fully engaged, the rotation for locking may be less than ninety degrees (90°), or if there is sufficient room for subsequent rotation of the take-up hub 2652 during operation, the rotation for locking may be greater than ninety degrees (90°).

[0224] When the take-up hub 2652 is rotated to convert the bayonet connection 2649 from an open or unlocked state to a closed or locked state, the nut 2656 also rotates because the nut 2656 engages with the take-up hub 2652 and rotates therewith. Figure 26E Nut 2656 is described in more detail and will be referenced Figure 26F The take-up hub 2652 is described in more detail. Figure 26E FIG2 is a perspective view of nut 2656 after it has been removed from tensioning mechanism 2651, for illustrative purposes only. Nut 2656 is disposed between and coupled to take-up hub 2652 and base 2654. Nut 2656 is coupled to take-up hub 2652 via a spline connection (similar to spline connection 159A), such that take-up hub 2652 and nut 2656 rotate together, while preventing relative rotation between take-up hub 2652 and nut 2656. In other words, due to the spline connection, take-up hub 2652 is rotationally locked to nut 2656, allowing nut 2656 and take-up hub 2652 to rotate as a single unit. Nut 2656 operates similarly to nut 156A described herein, but with a different structure. In this embodiment, the spline connection includes a plurality of outwardly extending ribs 2617 that protrude or extend radially outward from the outer circumferential surface of the lower flange portion of the nut 2656, and each of the outwardly extending ribs is received within an axial groove 2615 of the take-up hub 2652. The take-up hub 2652 includes a plurality of axial grooves 2615 formed on the inner circumferential surface of the take-up hub 2652. Each outwardly extending rib 2617 is allowed to slide or move axially along the axial groove 2615, so that the nut 2656 is allowed to slide or move axially relative to the take-up hub 2652, but the outwardly extending ribs 2617 do not allow the nut 2656 to rotate relative to the take-up hub 2652.

[0225] Unlike the inwardly extending ribs 119A of the nut 156A, the nut 2656 includes an upper follower portion or cam follower portion disposed axially above the flange portion of the nut 2656. The cam follower portion of the nut 2656 includes a lower surface 2619 that mates with and corresponds to the helical inclined surface 2613 of the cam surface 2655 such that the cam follower portion of the nut 2656 is disposed on and engaged with the cam surface 2655 of the base 2654.

[0226] When the take-up hub 2652 is axially assembled to the base 2654 before locking the bayonet connection 2649, the take-up hub 2652 also engages the nut 2656 such that relative rotation is not permitted between the take-up hub 2652 and the nut 2656. Thus, when the bayonet connection 2649 is locked, the nut 2656 also rotates relative to the base 2654, thereby reducing the amount of rotation or movement that the nut 2656 can achieve during normal operation. Figure 26G 、 Figure 26H and Figure 26IA nesting fixture or tool 2677 is depicted that can be temporarily attached to the base 2654 to facilitate initial installation or assembly of the nut 2656 to the base 2654 prior to installation of the take-up hub 2652, such that the nut 2656 is rotated backward from the target initial position by an amount equal to the locking rotation. Thus, after assembly is complete and the bayonet structure 2649 is locked (thereby rotating the nut 2656), once the take-up hub 2652 has been rotationally locked, the nut 2656 is rotated forward to return to the target initial position. When in the target initial position, the nut 2656 is fully biased downward against the base 2654 at the bottom of the cam surface 2655. The use of the nesting fixture 2677 maximizes the degree or amount of rotation that the nut 2656 can undergo relative to the base 2654 during normal use.

[0227] Nested Fixtures 2677 in Figure 26G The nesting fixture 2677 is configured to secure or maintain the nut 2656 at an elevated height relative to the base 2654 so that the nut 2656 is in the rotational position required for assembly if it is biased against the cam surface 2655 of the base 2654. The nesting fixture 2677 includes a plurality of upright members 2679, such as Figure 26H As shown, the upstanding member 2679 is sized and configured to pass through a plurality of apertures 2683 formed in the base 2654. The inner and outer diameters of the upstanding member 2679 are configured to allow the nut 2656 and the take-up hub 2652 to rotate during the locking rotation of the bayonet connection 2649 without interfering with the splined connection 2659 between the nut 2656 and the take-up hub 2652. The nesting fixture 2677 also includes a center locating pin 2681 for centering the base 2654 on the nesting fixture 2677 when the base 2654 is positioned on a top surface of the nesting fixture 2677. Figure 26I The base 2654 is shown disposed on a top surface of the nested fixture 2677 , with the upstanding member 2679 of the nested fixture 2677 extending through the aperture 2683 of the base 2654 .

[0228] Figure 26J The nut 2656 is shown disposed on or supported by a plurality of upstands 2679 at a position corresponding to ninety degrees (90°) rearward or displaced from the intended initial position of the nut 2656. The nut 2656 is rotationally secured by a rotation stop 2685 disposed between one of the upstands 2679 of the nested retainer 2677 and the nut 2656. The rotation stop 2685 ensures that the nut 2656 does not rotate out of engagement with the cam surface 2655.

[0229] Reference Figure 26K , when the reel hub 2652 (which is Figure 26K When the nut 2656 is rotated to lock the bayonet structure 2649 (not shown in the figure so that the nut 2656 can be seen), the nut 2656 rotates with the winding hub 2652 as described above, thereby traveling upward along the inclined surface 2613 of the cam surface 2655. Figure 26K As shown by the directional arrows in FIG, nut 2656 moves upward along inclined surface 2613 and over its apex, each of which is located at the meshing point between inclined surface 2613 and vertical surface 2611. As nut 2656 travels over the apex of cam surface 2655, nut 2656 is biased downward by compression spring 2658 back onto upstand 2679 of nesting fixture 2677, reaching the height defined by the upstand. When tensioning mechanism 2651 is removed from nesting fixture 2677, nut 2656 will continue to move toward base 2654 due to the spring force of compression spring 2658 until nut 2656 reaches the target initial position (i.e., fully biased downward to base 2654, located at the bottom of cam surface 2655).

[0230] Steering Figure 26L , shows another feature of the tensioning mechanism 2651. More specifically, as an auxiliary means for the dose counter to warn the user, the tensioning mechanism 2651 is configured to output an audible click to warn the user of the inhaler that the device is exhausted (i.e., all doses of the blister strip have been delivered). As the inhaler is operated and doses are delivered sequentially, the nut 2656 moves upward along the inclined surface 2613 of the cam surface 2655. Later in the life of the device, the nut 2656 moves upward along the inclined surface 2613 and is located at its vertices, each vertex being located at the meshing point between the inclined surface 2613 and the vertical surface 2611. If the user continues to operate the inhaler (i.e., by rotating the mouthpiece cover 108) after all doses have been dispensed, the nut 2656 will exceed the allocated or allowed amount of rotation and pass over the vertex of the cam surface 2655 (e.g., Figure 26L ). When the nut 2656 passes over the apex of the cam surface 2655 and disengages from the inclined surface 2613, the nut 2656 is biased downwardly back to the base 2654 by the compression spring 2658, thereby generating or outputting an audible click sound.

[0231] Steering Figure 26M and Figure 26N, shows another feature of the tensioning mechanism 2651. More specifically, the tensioning mechanism 2651 includes a locking mechanism 2687 that is configured to prevent disassembly of the bayonet connection 2649 if the user continues to attempt to operate the inhaler device after all doses have been dispensed. In other words, the locking mechanism 2687 limits the extent to which the take-up hub 2652 can be wound or rotated to prevent the male and female bayonet structures of the bayonet connection 2649 from realigning and prevents the take-up hub 2652 from being disassembled axially due to the force of the compression spring 2658 within the take-up hub 2652.

[0232] As previously described, the nut 2656 includes a plurality of outwardly extending ribs 2617 that protrude or extend radially outward from the outer circumferential surface of the nut 2656 for engagement with the take-up hub 2652. In this embodiment, the outwardly extending ribs 2617 also serve as a stop for the locking mechanism 2687. More specifically, in this embodiment, the nut 2656 includes a total of three outwardly extending ribs 2617 that are circumferentially spaced at equal intervals (i.e., spaced 120° apart around the outer circumferential surface of the nut 2656). After all doses have been dispensed and the nut 2656 has traveled past the apex of the cam surface 2655, as described above with respect to Figure 26L As described above, the outwardly extending ribs 2617 will be in a position different from the initial position and will be located on the base 2654. The base 2654 includes a plurality of cavities 2689 that are configured to receive the outwardly extending ribs 2617 at the end of the service life state. When the outwardly extending ribs 2617 are received in the cavities 2689, any further rotation of the nut 2656 (and thus the reel hub 2652 locked thereto) is prevented. Although the cavities 2689 are sufficient to accommodate the outwardly extending ribs 2617 and prevent further rotation of the nut 2656, the locking mechanism 2687 can include a plurality of raised stops 2691 disposed on the base 2654 adjacent to the cavities 2689 to increase vertical engagement with the outwardly extending ribs 2617.

[0233] Figure 26M shows the starting or initial position of the outwardly extending ribs 2617 at the beginning of the device's useful life, while Figure 26N The final position of the outwardly extending ribs 2617 is shown later in the life of the device after all doses have been dispensed and the nut 2656 has passed the apex of the cam surface 2655. Figure 26MIn the starting position, the outwardly extending ribs 2617 of the nut 2656 are initially located in the spirally distributed clearance grooves 2693 and can rotate during operation of the inhaler device. The base 2654 includes a total of three clearance grooves 2693 for receiving three outwardly extending ribs 2617. Each clearance groove 2693 is arranged in the middle of a pair of adjacent cavities 2689. Figure 26N In the end position, the nut 2656 has rotated 180° during operation of the inhaler device, rests on the cam surface 2655, and the outwardly extending rib 2617 is disposed within the cavity 2689 and is prevented from further rotation by the stop 2691 of the locking mechanism 2687.

[0234] The locking mechanism 2687 advantageously includes three relatively large diameter, equally spaced rotational stops that simultaneously maintain the same rotation of the nut 2656 relative to the base 2654 during normal operation. Before the locking mechanism 2687 is activated, the nut 2656 travels over the cam surface 2655 and about Figure 26J An audible click is described that signals that the locking mechanism 2687 has engaged.

[0235] Figures 27A-27D An alternative embodiment of a locking mechanism is shown that can be integrated into the tensioning mechanism 2651 to prevent the bayonet connection 2649 from disengaging. Figure 27A In the embodiment, the locking mechanism 2787A includes a rotation stop or block 2791A disposed at one end of the internal flange 2671 at the bayonet connection 2649. Figure 27B In the embodiment, the locking mechanism 2787B includes a rotation stop or block 2791B disposed on the lower periphery of the hub 2652. Figure 27C and Figure 27D In the embodiment, the locking mechanism 2787C includes a rotation stop or block 2791C disposed on the shaft 2657 at the top of the cam surface 2655 and a pair of opposing notches at the top of the nut 2656. In this embodiment, the nut includes a first notch 2789A that is relatively larger than the second notch 2789B. Figure 27C , the first notch 2789A is configured to allow the nut 2656 to pass over or disengage the cam surface 2655 during assembly of the tensioning mechanism 2651 when the bayonet connection 2649 is locked. Figure 27D The second cutout 2789B is configured to prevent the nut 2656 from passing over or falling off the cam surface 2655 at a later stage in the useful life of the device, thereby preventing the nut 2656 from further rotating relative to the base 2654.

[0236] Although various embodiments of the present invention have been described above, it should be understood that the foregoing is presented by way of example and illustration only and is not intended to limit the present invention. Those skilled in the art will appreciate that various changes may be made to its form and details without departing from the spirit and scope of the present invention. Therefore, the breadth and scope of the present invention should not be limited by the above-described exemplary embodiments, but should only be defined by the appended claims and their equivalents. In addition, it should be understood that the various features of each embodiment described in this specification, as well as the various features in the cited literature, may be used in combination with the features of any other embodiment. All patents and publications described herein are incorporated herein by reference in their entirety.

Claims

1. A tensioning mechanism for peeling a sheet from a blister strip suitable for use in a dry powder inhaler device, the tensioning mechanism comprising: base; a nut including at least one rib that engages the cam surface; a compression spring, the compression spring being adjacent to the nut in a longitudinal axial direction; and a take-up hub disposed about the nut and the compression spring, wherein the nut is disposed between and coupled to each of the take-up hub and the base, and wherein the take-up hub is rotationally constrained by the nut, and wherein the winding hub is configured to rotate relative to the base, and wherein when the base is rotationally driven, the nut is configured to interact with the compression spring and the cam surface to apply torque to the take-up hub, and When the winding hub applies opposite torque to the nut, the nut moves along the cam surface and compresses the compression spring in the axial direction.

2. The tensioning mechanism of claim 1 , wherein the take-up hub includes a hook portion disposed on an outer surface of the take-up hub, the hook portion being configured to connect to an end of the sheet of blister strip such that rotation of the take-up hub causes the sheet of blister strip to wrap around the take-up hub.

3. The tensioning mechanism of claim 1, wherein the take-up hub is axially constrained relative to the base.

4. The tensioning mechanism of claim 3, wherein the take-up hub is axially restrained relative to the base by a bayonet connection between the base and the take-up hub.

5. The tensioning mechanism of claim 4, wherein the bayonet connection comprises a radial extension on the base and an internal flange on the take-up hub, the internal flange comprising an axial slot configured to allow the radial extension to pass therethrough. 6 . The tensioning mechanism according to claim 1 , wherein the base comprises a plurality of gear teeth, and the plurality of gear teeth are integrally formed with or fixed to an outer circumferential surface of the base.

7. The tensioning mechanism of claim 1, wherein the cam surface comprises alternating vertical surface portions and inclined surface portions.

8. The tensioning mechanism of claim 7, wherein at least one of the ribs comprises a plurality of ribs arranged circumferentially.

9. The tensioning mechanism of claim 1 , wherein the cam surface is integrally formed with or fixed to a portion of the base, and wherein at least one of the ribs projects radially inward from an inner circumferential surface of the nut, and wherein the take-up hub is rotationally locked to the nut.

10. The tensioning mechanism of claim 9, wherein the compression spring extends between the take-up hub and the nut.

11. The tensioning mechanism of claim 9, wherein the take-up hub is rotationally locked to the nut by an outwardly extending rib that projects radially outward from an outer circumferential surface of the nut and is received in an axial groove of the take-up hub.

12. The tensioning mechanism of claim 9, wherein the cam surface has a first outer diameter and the compression spring has a second outer diameter, the first outer diameter being greater than the second outer diameter.

13. The tensioning mechanism of claim 1 , wherein the cam surface is integrally formed with or fixed to a portion of the take-up hub, and wherein at least one of the ribs projects radially outward from an outer circumferential surface of the nut, and wherein the base is rotationally locked to the nut.

14. The tensioning mechanism of claim 13 , wherein a shaft extends from the base, the shaft being integrally formed with or fixed to the base, wherein the base is rotationally locked to the nut by an inwardly extending rib, the inwardly extending rib protruding radially inwardly from the inner circumferential surface of the nut and being received in an axial groove of the shaft.

15. The tensioning mechanism of claim 1, wherein the compression spring extends between the nut and the base.

16. A dry powder inhaler device comprising: a housing for receiving at least one blister strip suitable for use in a dry powder inhaler device, the blister strip comprising a bottom sheet and a top sheet releasably secured to the bottom sheet; a tensioning mechanism according to claim 1 disposed within the housing; and, a positioning reel driven in rotation in a first direction, wherein an outer surface of the positioning reel receives the bottom sheet of the blister strip, wherein an outer surface of the take-up hub is attached to an end of the top sheet, and rotation of the take-up hub in a second, opposite direction causes the top sheet to wrap around the outer surface of the take-up hub, and wherein increased tension along the top sheet of the blister strip causes the take-up hub to rotate relative to the base in the first direction to reduce the tension along the top sheet of the blister strip, and The axial compression of the compression spring is converted into a torque applied to the winding hub.

17. A dry powder inhaler device comprising: a housing for receiving at least one blister strip suitable for use in a dry powder inhaler device, the blister strip comprising a bottom sheet and a top sheet releasably secured to the bottom sheet; a positioning reel rotationally driven in a first direction, wherein an outer surface of the positioning reel receives a bottom sheet of the blister strip; a take-up hub rotatably driven in a first direction or a second, opposite direction, wherein an outer surface of the take-up hub is attached to an end of the top sheet, rotation of the take-up hub causing the top sheet to wrap around the outer surface of the take-up hub; and a tensioning mechanism comprising a slider and at least one spring attached to the slider, wherein the tensioning mechanism is coupled to the housing to allow the slider to move axially relative to the housing along a predetermined path, wherein the slide is configured to receive a middle portion of the top sheet of the blister strip, the middle portion of the top sheet being disposed between the positioning reel and the take-up hub, and wherein increased tension along the top sheet of the blister strip causes the slider to move axially along the predetermined path, and wherein the axial movement of the slider axially compresses or stretches the spring to reduce tension along the top sheet of the blister strip.

18. The dry powder inhaler device of claim 17, wherein a first end of the spring is attached to the slider and a second end of the spring is attached to the housing.

19. The dry powder inhaler device of claim 17, wherein the predetermined path is formed by a groove in the inner surface of the housing.

20. The dry powder inhaler device of claim 17, wherein the spring is a compression spring, and the compression spring is biased to urge the slider away from each of the positioning spool and the take-up hub.

21. The dry powder inhaler device of claim 20, wherein axial compression of the compression spring moves the slider closer to each of the positioning spool and the take-up hub.

22. The dry powder inhaler device of claim 17, wherein the predetermined path is a linear predetermined path.

23. The dry powder inhaler device of claim 17, wherein the at least one spring comprises a single spring.

24. The dry powder inhaler device of claim 17, wherein the at least one spring comprises two springs.

25. The dry powder inhaler device of claim 17, wherein the take-up hub is rotationally driven in the first direction.

26. The dry powder inhaler device of claim 17, wherein the take-up hub is rotationally driven in a second, opposite direction.

27. The dry powder inhaler device of claim 17, wherein the at least one spring is a compression spring, and axial movement of the slider compresses the spring axially to reduce tension along the top sheet of the blister strip.

28. The dry powder inhaler device of claim 17, wherein the at least one spring is a tension spring, and axial movement of the slider stretches the spring axially to reduce tension along the top sheet of the blister strip.

29. A dry powder inhaler device comprising: a housing for receiving at least one blister strip suitable for use with a dry powder inhaler device, the blister strip comprising a bottom sheet and a top sheet releasably secured to the bottom sheet, wherein the housing comprises a curved slot on an inner surface thereof and a pin extending radially from the inner surface of the housing, the pin being disposed adjacent a first end of the curved slot and secured to the housing; a positioning reel rotationally driven in a first direction, wherein an outer surface of the positioning reel receives a bottom sheet of the blister strip; a take-up hub rotationally driven in a second, opposite direction, wherein an outer surface of the take-up hub is connected to an end of the top sheet, rotation of the take-up hub causes the top sheet to wrap around the outer surface of the take-up hub, and wherein the take-up hub is coupled to the housing to allow the take-up hub to move relative to the housing along the curved slot; and a tensioning mechanism comprising at least one spring coupled to the take-up hub, wherein a first end of the spring is fixed to the housing and a second end of the spring is coupled to the take-up hub, wherein the pin is configured to receive a middle portion of the top sheet of the blister strip, the middle portion of the top sheet extending between the positioning reel and the take-up hub, and wherein increased tension along the top sheet of the blister strip causes the take-up hub to move along the curved slot of the housing, and wherein movement of the take-up hub deforms the spring in an axial direction to reduce tension along the top sheet of the blister strip.

30. The dry powder inhaler device of claim 29, wherein the at least one spring is a tension spring.

31. The dry powder inhaler device of claim 29, wherein the tensioning mechanism comprises a bracket having a first end, a second end, and a middle portion, the first end being coupled to allow relative rotation of the positioning spool relative to the bracket, the second end being connected to the second end of the spring, and the middle portion being coupled to the take-up hub to allow relative rotation of the take-up hub relative to the bracket.

32. A dry powder inhaler device according to claim 31 , wherein the support is rotatable relative to the housing.

33. The dry powder inhaler device of claim 32, wherein the spring is biased to position the take-up hub at a second end of the curved slot, the second end opposite the first end of the curved slot and the pin, and wherein movement of the take-up hub in a direction toward the pin axially extends the tension spring to reduce tension along the top sheet of the blister strip.

34. The dry powder inhaler device of claim 29, wherein the spring is arranged aligned with a centerline of the top sheet.

35. The dry powder inhaler device of claim 29, wherein the curved slot is concentric with the axis of rotation of the positioning spool.

36. The dry powder inhaler device of claim 29, wherein the at least one spring is a torsion spring.

37. The dry powder inhaler device of claim 36, wherein the at least one spring comprises a first torsion spring configured to act on a first side of the take-up hub and a second torsion spring configured to act on a second, opposite side of the take-up hub.

38. The dry powder inhaler device of claim 36, wherein a first leg of the torsion spring is fixed to an inner surface of the housing, and a second leg of the torsion spring is coupled to the take-up hub for movement along the curved slot with the take-up hub.

39. A dry powder inhaler device according to claim 38, wherein the body of the torsion spring is arranged concentrically with the axis of rotation of the positioning spool.

40. The dry powder inhaler device of claim 38, wherein the torsion spring is biased to position the take-up hub at a second end of the curved slot, the second end opposite the curved slot and the first end of the pin, and movement of the take-up hub in a direction toward the pin twists the torsion spring to reduce tension along the top sheet of the blister strip.

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