Soft mist inhaler and improvements therefor

Abstract

An inhaler includes an atomization subassembly including an aerosolizing nozzle, a compression subassembly, and upper and lower casings each having a generally elliptical form. The compression subassembly is configured to convey a predetermined dosage amount of a liquid medicament to the atomization subassembly, and includes a stop ring, a capillary holder, a spring, and a driving tube having a continuous groove formed on an outer surface thereof. An interior surface of the upper casing includes first and second snap features configured to be received within the continuous groove of the driving tube. The driving tube has a substantially circular cross-section and the upper casing has a substantially elliptical cross-section. An inner surface of each of the first snap feature and the second snap feature is configured to deform upon assembly so as to correspond to a curvature of the outer surface of the driving tube within the continuous groove.

Description

SOFT MIST INHALERAND IMPROVEMENTS THEREFORCROSS REFERENCE OF RELATED APPLICATIONS

[0001] This application claims the benefit of U.S. Provisional Patent Application No. 63 / 720386, filed November 14, 2024, which is hereby incorporated by reference in its entirety for all purposes.FIELD OF THE INVENTION

[0002] The invention relates in general to an inhaler device, and more particularly to an inhaler device configured to produce an inhalable aerosol of a liquid medicament without the use of propellant gas.BACKGROUND OF THE INVENTION

[0003] Soft-mist inhalers, also known as atomizers or aerosolizers, are used to deliver medication to patients for inhalation. Particularly, liquid medicament is broken down into aerosol, i.e. a mist of fine liquid particles or droplets, for easier and more efficient inhalation and absorption. Some aerosol dispensers use a gas to propel the liquid and some aerosol dispensers use mechanical solutions without a propelling gas to expel the liquid.BRIEF SUMMARY OF THE INVENTION

[0004] According to a first embodiment hereof, the disclosure provides an inhaler including a compression subassembly. The compression subassembly includes an annular stop ring having an inner diameter defining an opening therethrough, a capillary holder having an outer diameter that is less than the inner diameter of the stop ring such that the capillary holder can pass through the opening of the stop ring when the stop ring and the capillary holder are concentrically aligned, and a spring. The stop ring is displaceable between a first position in which the stop ring and the capillary holder are concentrically aligned and a second position in which the stop ring is laterally shifted to partially overlap the capillary holder. The stop ring is configured to block axial upwards movement of the capillary holder when in the second position to maintain the spring in a compressed state. When the stop ring is in the second position, each of a top surface of the capillary holder and a bottom surface of the stop ring includes an overlapping portion and a non-overlappingportion, the respective overlapping portions being radially aligned with each other and the respective non-overlapping portions being radially offset from each other. The bottom surface of the stop ring includes at least one upwardly-extending step disposed between a contact section of the overlapping portion thereof and a non-contact section of the overlapping portion thereof. The upwardly-extending step is configured to longitudinally offset the non-contact section of the overlapping portion of the stop ring from the top surface of the capillary holder to prevent contact therebetween.

[0005] In an aspect of the first embodiment, and in combination with any other aspects herein, the contact section of the overlapping portion of the stop ring contacts the top surface of the capillary holder when the stop ring is in the second position.

[0006] In an aspect of the first embodiment, and in combination with any other aspects herein, the overlapping portion of the capillary holder includes a contact section and a non-contact section. The contact section of the capillary holder is in contact with the contact section of the stop ring when the stop ring is in the second position and the non-contact section of the capillary holder is longitudinally spaced apart from the non-contact section of the stop ring when the stop ring is in the second position.

[0007] In an aspect of the first embodiment, and in combination with any other aspects herein, the bottom surface of the stop ring includes two opposing upwardly-extending steps, each upwardly-extending step disposed between the contact section of the overlapping portion thereof and the non-contact section of the overlapping portion thereof. Each upwardly-extending step is configured to longitudinally space apart the non-contact section of the overlapping portion of the stop ring from the top surface of the capillary holder to create a gap which prevents contact therebetween.

[0008] In an aspect of the first embodiment, and in combination with any other aspects herein, the overlapping portion and the non-overlapping portion of the top surface of the capillary holder collectively extend around an entire circumference of the capillary holder. The overlapping portion and the non-overlapping portion of the bottom surface of the stop ring collectively extend around an entire circumference of the stop ring.

[0009] In an aspect of the first embodiment, and in combination with any other aspects herein, the upwardly-extending step extends at an oblique angle with respect to the contact section of the overlapping portion of the stop ring.

[0010] In an aspect of the first embodiment, and in combination with any other aspects herein, the upwardly-extending step is configured to prevent a load being applied between the non-contact sections of the overlapping portions of the stop ring and the capillary holder, respectively.

[0011] In an aspect of the first embodiment, and in combination with any other aspects herein, a trigger is connected to the stop ring and the trigger laterally protrudes from an opening of a casing of the inhaler when the stop ring is in the second position.

[0012] In an aspect of the first embodiment, and in combination with any other aspects herein, the stop ring includes a protrusion extending from the contact section thereof, the protrusion extending in a radially outward direction.

[0013] In an aspect of the first embodiment, and in combination with any other aspects herein, the contact section of the overlapping portion of the stop ring contacts the top surface of the capillary holder when the stop ring is in the second position and the protrusion is configured to maximize an area of the contact section. The protrusion has a first radial width and the capillary holder has a second radial width, the first radial width being between 75% and 125% greater than the second radial width.

[0014] In an aspect of the first embodiment and in combination with any other aspects herein, the inhaler further comprises an upper casing and a lower casing, the upper casing being rotatably connected to the lower casing and together being configured to collectively house the compression subassembly and a cartridge therein, the cartridge comprising a liquid medicament.

[0015] According to a second embodiment hereof, the present disclosure provides an inhaler including a compression subassembly. The compression subassembly includes an annular stop ring having an inner diameter defining an opening therethrough, a capillary holder having an outer diameter that is less than the inner diameter of the stop ring such that the capillary holder can pass through the opening of the stop ring when the stop ring and the capillary holder are concentrically aligned, and a spring. The inhaler further includes an upper casing and a lower casing, the uppercasing being rotatably connected to the lower casing and together being configured to collectively house the compression subassembly therein. The upper casing defines a compartment between a first interior surface and a second interior surface, the stop ring and at least a portion of the capillary holder being disposed within the compartment. The stop ring is displaceable between a first position in which the stop ring and the capillary holder are concentrically aligned and a second position in which the stop ring is laterally shifted in a first direction to partially overlap the capillary holder. The stop ring is configured to block axial upwards movement of the capillary holder when in the second position to maintain the spring in a compressed state. The first interior surface of the upper casing includes a helical ramp configured to interact with the capillary holder and the second interior surface of the upper casing includes at least one ramp configured to interact with the stop ring. The at least one ramp is configured to provide resistance during movement of the stop ring in a second direction, the second direction opposing the first direction.

[0016] In an aspect of the second embodiment, and in combination with any other aspects herein, the at least one ramp extends at an oblique angle with respect to a longitudinal axis of the inhaler.

[0017] In an aspect of the second embodiment, and in combination with any other aspects herein, the at least one ramp is configured to urge the stop ring in an axially downward direction towards the lower casing when the stop ring moves in the second direction.

[0018] In an aspect of the second embodiment, and in combination with any other aspects herein, the second interior surface of the upper casing includes two ramps configured to interact with the stop ring. Each ramp is configured to provide resistance during movement of the stop ring in a second direction, the second direction opposing the first direction.

[0019] In an aspect of the second embodiment, and in combination with any other aspects herein, the two ramps include a first ramp and a second ramp, the first ramp being disposed between 60 and 120 degrees away from the second ramp.

[0020] In an aspect of the second embodiment, and in combination with any other aspects herein, the first ramp is disposed between 80 and 100 degrees away from the second ramp.

[0021] In an aspect of the second embodiment, and in combination with any other aspects herein, a trigger is connected to the stop ring and the trigger laterally protrudes from an opening of the upper casing when the stop ring is in the second position.

[0022] In an aspect of the second embodiment, and in combination with any other aspects herein, when the stop ring is in the second position, each of a top surface of the capillary holder and a bottom surface of the stop ring includes an overlapping portion and a non-overlapping portion, the respective overlapping portions being radially aligned with each other and the respective nonoverlapping portions being radially offset from each other. The bottom surface of the stop ring includes at least one upwardly-extending step disposed between a contact section of the overlapping portion thereof and a non-contact section of the overlapping portion thereof. The upwardly-extending step is configured to longitudinally offset the non-contact section of the overlapping portion of the stop ring from the top surface of the capillary holder to create a gap which prevents contact therebetween.

[0023] In an aspect of the second embodiment, and in combination with any other aspects herein, the contact section of the overlapping portion of the stop ring contacts the top surface of the capillary holder when the stop ring is in the second position.

[0024] In an aspect of the second embodiment, and in combination with any other aspects herein, the overlapping portion of the capillary holder includes a contact section and a non-contact section, the contact section of the capillary holder being in contact with the contact section of the stop ring when the stop ring is in the second position and the non-contact section of the capillary holder being longitudinally spaced apart from the non-contact section of the stop ring when the stop ring is in the second position.

[0025] In an aspect of the second embodiment, and in combination with any other aspects herein, the bottom surface of the stop ring includes two opposing upwardly-extending steps, each upwardly-extending step is disposed between the contact section of the overlapping portion thereof and the non-contact section of the overlapping portion thereof. Each upwardly-extending step is configured to longitudinally space apart the non-contact section of the overlapping portion of the stop ring from the top surface of the capillary holder to create a gap which prevents contact therebetween.

[0026] In an aspect of the second embodiment, and in combination with any other aspects herein, the overlapping portion and the non-overlapping portion of the top surface of the capillary holder collectively extend around an entire circumference of the capillary holder. The overlapping portion and the non-overlapping portion of the bottom surface of the stop ring collectively extend around an entire circumference of the stop ring.

[0027] In an aspect of the second embodiment, and in combination with any other aspects herein, the upwardly-extending step extends at an oblique angle with respect to the contact section of the overlapping portion of the stop ring.

[0028] In an aspect of the second embodiment, and in combination with any other aspects herein, the upwardly-extending step is configured to prevent a load being applied between the non-contact sections of the overlapping portions of the stop ring and the capillary holder, respectively.

[0029] In an aspect of the second embodiment, and in combination with any other aspects herein, the stop ring includes a protrusion extending from the contact section thereof, the protrusion extending in a radially outward direction.

[0030] In an aspect of the second embodiment, and in combination with any other aspects herein, the contact section of the overlapping portion of the stop ring contacts the top surface of the capillary holder when the stop ring is in the second position and the protrusion is configured to maximize an area of the contact section. The protrusion has a first radial width and the capillary holder has a second radial width, the first radial width being between 75% and 125% greater than the second radial width.

[0031] According to a third embodiment hereof, the present disclosure provides an inhaler including an atomization subassembly and a compression subassembly. The atomization subassembly includes a nozzle configured to produce an aerosol, and a central tube defining an axial lumen therethrough and having a plurality of ribs around a circumference thereof, each rib of the plurality of ribs having a retention pad formed thereon. The compression subassembly includes a stop ring, a capillary holder having a capillary tube slidingly disposed within the axial lumen of the central tube, and a spring. The inhaler further includes an upper casing and a lower casing, the upper casing being rotatably connected to the lower casing and together beingconfigured to collectively house the atomization subassembly and the compression subassembly therein. Each retention pad has an inclined outer surface that is configured to contact an inner surface of the upper casing, the inclined outer surface flaring radially outward from a top end to a bottom end. The bottom end of the inclined outer surface has an edge.

[0032] In an aspect of the third embodiment, and in combination with any other aspects herein, the plurality of ribs includes four ribs.

[0033] In an aspect of the third embodiment, and in combination with any other aspects herein, the four ribs are equally spaced around a circumference of the central tube.

[0034] In an aspect of the third embodiment, and in combination with any other aspects herein, each retention pad has a variable thickness that increases from the top end to the bottom end thereof.

[0035] In an aspect of the third embodiment, and in combination with any other aspects herein, the edge at the bottom end of the inclined outer surface extends substantially perpendicular to a longitudinal axis of the inhaler.

[0036] In an aspect of the third embodiment, and in combination with any other aspects herein, each retention pad is integrally formed on the central tube.

[0037] In an aspect of the third embodiment, and in combination with any other aspects herein, the central tube is formed from a first polymer material and the upper casing is formed from a second polymer material, the first polymer material being harder than the second polymer material.

[0038] In an aspect of the third embodiment, and in combination with any other aspects herein, the first polymer material is polyether ether ketone (PEEK) and the second polymer material is acrylonitrile butadiene styrene (ABS).

[0039] According to a fourth embodiment hereof, the present disclosure provides an inhaler including an atomization subassembly and a compression subassembly. The atomization subassembly includes an aerosolizing nozzle. The compression subassembly is configured to convey a predetermined dosage amount of a liquid medicament to the atomization subassembly. The compression subassembly includes a stop ring, a capillary holder, a spring, and a driving tubehaving a continuous groove formed on an outer surface thereof. The inhaler further includes an upper casing and a lower casing, the upper casing being rotatably connected to the lower casing and together being configured to collectively house the atomization subassembly and the compression subassembly therein. Each of the upper casing and the lower casing have a generally elliptical external form. An interior surface of the upper casing includes a first snap feature and a second snap feature, each of the first snap feature and the second snap feature being configured to be received within the continuous groove of the driving tube. The driving tube has a substantially circular cross-section and the upper casing has a substantially elliptical cross-section. An inner surface of each of the first snap feature and the second snap feature is configured to deform upon assembly so as to correspond to a curvature of the outer surface of the driving tube within the continuous groove.

[0040] In an aspect of the fourth embodiment, and in combination with any other aspects herein, the first snap feature is diametrically opposed to the second snap feature.

[0041] In an aspect of the fourth embodiment, and in combination with any other aspects herein, the first snap feature and the second snap feature are aligned along a minor axis of the elliptical cross-section.

[0042] In an aspect of the fourth embodiment, and in combination with any other aspects herein, the interior surface of the upper casing also includes a first crush rib and a second crush rib, each of the first crush rib and the second crush rib being configured to abut against the outer surface of the driving tube. The first crush rib is diametrically opposed to the second crush rib and the first crush rib and the second crush rib are aligned along a major axis of the elliptical cross-section.

[0043] In an aspect of the fourth embodiment, and in combination with any other aspects herein, a spindle is coupled to the driving tube so as to allow rotation of the spindle relative to the driving tube and a rider is coupled to the spindle, the rider being rotationally constrained such that the rider moves axially when the spindle rotates relatives to the driving tube. A position of the rider is configured to be a dosage counter, and the spindle and the driving tube include mating surfaces that are configured to abut against each other to form a detent.

[0044] In an aspect of the fourth embodiment, and in combination with any other aspects herein, the mating surfaces are angled and configured to provide resistance to rotation of the spindle relative to the driving tube by hand alone.

[0045] The inhaler of any of the second, third, and / or fourth embodiments, and in combination with any other aspects herein, wherein the upper casing and the lower casing are configured to collectively house a cartridge therein, the cartridge comprising a liquid medicament.

[0046] The inhaler of any of the first through fourth embodiments, and in combination with any other aspects herein, wherein the liquid medicament comprises a beta-mimetic, an anticholinergic, a vasodilator / bronchodilator, a corticosteroid, a PDE inhibitor, a leukotriene antagonist, an EGFR-inhibitor, an Hl, H2, and / or H3-antihistamine, a PAF antagonist, a PI3 kinase inhibitor, GPL-1 agonists, a non-prostanoid prostacyclin receptor agonist, an antifibrotic, an antifungal, an antibiotic, an antiviral, an anti-tumor agent, an anti-inflammatory, mRNA, siRNA or DNA-based therapeutic, a muscarinic beta 2 agonist, a peptide or protein therapeutic, a monoclonal antibody, an antibody-drug conjugate, a radio pharmaceutical, other active pharmaceutical ingredients, pharmaceutically acceptable salts thereof, or any combination thereof.BRIEF DESCRIPTION OF THE FIGURES

[0047] The foregoing and other features and advantages of the invention will be apparent from the following description of embodiments hereof as illustrated in the accompanying drawings. The accompanying drawings, which are incorporated herein and form a part of the specification, further serve to explain the principles of the invention and to enable a person skilled in the pertinent art to make and use the invention. The drawings are not to scale.

[0048] FIG. 1 is a perspective view of an inhaler according to an embodiment hereof, wherein the inhaler is in a first configuration in which a cap thereof is in a closed configuration.

[0049] FIG. 2 is a perspective view of the inhaler of FIG. 1, wherein the inhaler is in a second configuration in which the cap thereof is in an open configuration.

[0050] FIG. 3 is an exploded side view of the inhaler of FIG. 1, wherein an upper casing, a lower casing, and a cartridge are depicted in a disassembled state.

[0051] FIG. 4 is an exploded view illustrating the components of the inhaler of FIG. 1.

[0052] FIGS. 5A and 5B are side sectional views of the inhaler of FIG. 1, wherein the inhaler is in the first configuration in which the cap thereof is in the closed configuration and the inhaler has not yet been primed.

[0053] FIG. 6 is an enlarged view of a portion of FIG. 5B, the portion of FIG. 5B being shown within dashed lines and illustrating an atomization subassembly of the inhaler.

[0054] FIG. 7 is a perspective view of a central tube of the atomization subassembly of FIG. 6, wherein the central tube is removed from the inhaler for sake of illustration only.

[0055] FIG. 8 is a top view of the central tube of FIG. 7.

[0056] FIG. 9 is an enlarged view of a portion of FIG. 7.

[0057] FIG. 10 is another enlarged view of a portion of FIG. 7.

[0058] FIG. 11A is a side sectional view of the inhaler of FIG. 1, wherein the inhaler is in the first configuration in which the cap thereof is in the closed configuration and the inhaler has not yet been primed.

[0059] FIG. 1 IB is a side sectional view of the inhaler of FIG. 1, wherein the inhaler is in the first configuration in which the cap thereof is in the closed configuration and the inhaler is in a first stage of the priming operation.

[0060] FIG. 11C is a side sectional view of the inhaler of FIG. 1, wherein the inhaler is in the first configuration in which the cap thereof is in the closed configuration and the inhaler is in a second stage of the priming operation.

[0061] FIG. 1 ID is a side sectional view of the inhaler of FIG. 1, wherein the inhaler is in the first configuration in which the cap thereof is in the closed configuration and the inhaler is in a third stage of the priming operation.

[0062] FIG. 1 IE is a side sectional view of the inhaler of FIG. 1 , wherein the inhaler is in the first configuration in which the cap thereof is in the closed configuration and the inhaler is in a fourth stage of the priming operation.

[0063] FIG. 12 is an enlarged view of a portion of FIG. 11C, illustrating a first position of a stop ring of the inhaler at the second stage of the priming operation.

[0064] FIG. 13 is an enlarged view of a portion of FIG. 11D, illustrating a second position of a stop ring of the inhaler at the third stage of the priming operation.

[0065] FIG. 14 is a perspective view of the stop ring of the inhaler, a trigger of the inhaler, and a capillary holder of the inhaler when the stop ring is in the first position, wherein the components are shown removed from the inhaler for sake of illustration only.

[0066] FIG. 15 is a top view of the stop ring of the inhaler, the trigger of the inhaler, and the capillary holder of the inhaler when the stop ring is in the first position, wherein the components are shown removed from the inhaler for sake of illustration only.

[0067] FIG. 16 is a side view of the stop ring of the inhaler, the trigger of the inhaler, and the capillary holder of the inhaler when the stop ring is in the first position, wherein the components are shown removed from the inhaler for sake of illustration only.

[0068] FIG. 17 is a perspective view of the stop ring of the inhaler, the trigger of the inhaler, and the capillary holder of the inhaler when the stop ring is in the second position, wherein the components are shown removed from the inhaler for sake of illustration only.

[0069] FIG. 18 is a top view of the stop ring of the inhaler, the trigger of the inhaler, and the capillary holder of the inhaler when the stop ring is in the second position, wherein the components are shown removed from the inhaler for sake of illustration only.

[0070] FIG. 19 is a side view of the stop ring of the inhaler, the trigger of the inhaler, and the capillary holder of the inhaler when the stop ring is in the second position, wherein the components are shown removed from the inhaler for sake of illustration only.

[0071] FIG. 20 is a top view of the stop ring of the inhaler, the trigger of the inhaler, and the capillary holder of the inhaler when the stop ring is in the second position, wherein the components are shown removed from the inhaler for sake of illustration only and wherein the stop ring is shown in phantom to illustrate an overlapping region of the stop ring and the capillary holder.

[0072] FIG. 20A is a schematic illustration of a top view of the overlapping region of the stop ring and the capillary holder of FIG. 20.

[0073] FIG. 21 is a bottom view of the stop ring and the trigger of the inhaler, wherein the components are shown removed from the inhaler for sake of illustration only.

[0074] FIG. 22 is a top view of the capillary holder of the inhaler, wherein the capillary holder is shown removed from the inhaler for sake of illustration only.

[0075] FIG. 23 is a perspective view of the stop ring of the inhaler and the capillary holder of the inhaler when the stop ring is in the second position, wherein the stop ring and the capillary holder are shown removed from the inhaler for sake of illustration only.

[0076] FIG. 24 is a side view of the stop ring and the capillary holder of the inhaler when the stop ring is in the second position, wherein the stop ring and the capillary holder are shown removed from the inhaler for sake of illustration only.

[0077] FIG. 25 is an enlarged perspective view of portions of the stop ring and the capillary holder of the inhaler when the stop ring is in the second position, wherein the stop ring and the capillary holder are shown removed from the inhaler for sake of illustration only.

[0078] FIG. 26 is an enlarged bottom view of a portion of the stop ring the inhaler, wherein the stop ring is shown removed from the inhaler for sake of illustration only.

[0079] FIG. 27 is an enlarged top view of a portion of the capillary holder of the inhaler, wherein the capillary holder is shown removed from the inhaler for sake of illustration only.

[0080] FIG. 28 is a perspective view of the upper casing of the inhaler, wherein the upper casing is shown removed from the inhaler for sake of illustration only.

[0081] FIG. 29 is a bottom view of the upper casing of FIG. 28.

[0082] FIG. 30 is another perspective view of the upper casing of FIG. 28, showing an interior surface thereof.

[0083] FIG. 31 is a perspective sectional view of the stop ring, the capillary holder, and the upper casing of the inhaler when the stop ring is in the second position, wherein the stop ring, the capillary holder, and the upper casing are shown removed from the inhaler for sake of illustration only.

[0084] FIG. 32 is a perspective sectional view of the driving tube and the upper casing of the inhaler, wherein the driving tube and the upper casing are shown removed from the inhaler for sake of illustration only.

[0085] FIG. 33 is a perspective view of the upper casing, the driving tube, the spindle and the rider of the inhaler, wherein the components are shown removed from the inhaler for sake of illustration only.

[0086] FIG. 34 is also a perspective view of the upper casing, the driving tube, the spindle and the rider of the inhaler, wherein the components are shown removed from the inhaler for sake of illustration only and wherein the upper casing is shown in phantom to better illustrate the connection between the spindle and the driving tube.

[0087] FIG. 35 is a cross-sectional view of the upper casing and the spindle, wherein the components are shown removed from the inhaler for sake of illustration only.

[0088] FIG. 36A is a sectional perspective view illustrating the spindle in a first position relative to the upper casing.

[0089] FIG. 36B is a sectional perspective view illustrating the spindle in a second position relative to the upper casing.

[0090] FIG. 37 is a sectional perspective view illustrating a detent feature between the spindle and the driving tube.

[0091] FIG. 38 is another sectional perspective view illustrating the detent feature between the spindle and the driving tube.

[0092] FIG. 39 is a cross-sectional view of the driving tube and the spindle, wherein the components are shown removed from the inhaler for sake of illustration only.DETAILED DESCRIPTION

[0093] Specific embodiments are described with reference to the figures, wherein like reference numbers indicate identical or functionally similar elements. The following detailed description is merely exemplary in nature and is not intended to be limiting. Although the description of the following embodiments are in the context of soft mist inhaler devices, the following embodiments may also be used in other applications where it is deemed useful. Furthermore, there is no intention to be bound by any expressed or implied theory presented in the preceding technical field, background, brief summary or the following detailed description.

[0094] The main components of an inhaler 100 according to embodiments herein are shown in FIGS. 1-6. The inhaler 100 includes a cap 102, an upper casing 104 having a trigger or actuator 108 and a mouthpiece 105, and a lower casing 106. FIG. 1 depicts the inhaler 100 in a first configuration, in which the cap 102 is in a closed configuration and extends over the trigger 108 and the mouthpiece 105 to conceal the same from the user. FIG. 2 depicts the inhaler in a second configuration, in which the cap 102 is in an open configuration and the trigger 108 and the mouthpiece 105 are exposed to the user. The cap 102 is connected to the upper casing 104 via a hinge and is movable between the open and closed configurations. The upper casing 104 and the lower casing 106 collectively house a cartridge 110. FIG. 3 depicts an exploded view of the upper casing 104, the lower casing 106, and the cartridge 110. The cartridge 110 is a reservoir for a liquid medicament to be atomized. The cartridge 110 preferably contains a sufficient amount of the liquid medicament for at least one or more than one doses thereof such that the inhaler 100 is configured to allow multiple atomizations or applications. The cartridge 110 is rigid and the liquid medicament is received in a collapsible bag therein as will be understood by one of ordinary skill in the art. Upon atomization of the liquid medicament, a respirable aerosol is formed which can be inhaled by a user. Usually, the inhalation takes place at predetermined time intervals accordingto a dosing schedule, depending on the disease of the patient, although in some instances the inhalation takes place on an as-needed interval.

[0095] As used herein, unless explicitly stated to the contrary, “top” refers to a first end of the inhaler 100 that includes the cap 102 and “bottom” refers to a second end of the inhaler 100 opposite from the first end. Further, “downward” or “downwardly” refers to a direction towards the bottom of the inhaler 100 and “upwards” or “upwardly” refers to a direction towards the top of the inhaler. The inhaler 100 has a longitudinal axis extending from the first end to the second end thereof.

[0096] Turning now to FIGS. 4, 5 A, 5B, the internal components of the inhaler 100 will now be introduced. FIG. 4 is an exploded view of the components of the inhaler 100, while FIGS. 5A and 5B are sectional side views of the inhaler 100. The inhaler 100 can include a pressure generator or compression subassembly 111 and an atomization subassembly 130. The compression subassembly 111 includes a stop ring 112, a driving tube 114, a capillary holder 120 which holds a capillary or conveying tube 124 having a valve body 122 disposed at an end thereof, a biasing component or spring 126, and a spring retainer 128. The driving tube 114 further includes a locking spring 116, a spindle 118, and a rider 119, which collectively function as a dose indicator for the inhaler 100 for indicating the number of doses left in the cartridge 110. During priming, as will be described in more detail herein, the lower casing 106 is rotated with respect to the upper casing 104 and the spring 126 is further compressed as a result of the rotation. As a result of further compressing the spring 126, liquid medicament is drawn up from the cartridge 110 via the capillary tube 124, ready to be atomized. The capillary tube 124 provides a fluid path that permits pressurized liquid medicament to travel in an axially upwards direction, i.e., towards the cap 102, from a high pressure point to a low pressure point. As the capillary tube 124 moves during priming of the inhaler 100, a dose or metering chamber 145 formed within the atomization subassembly is expanded and a pressure differential is established therein. The pressure differential causes the liquid medicament in the cartridge 110 to be sucked into the metering chamber 145 via the capillary tube 124. Accordingly, during priming, the compression subassembly 111 conveys a predetermined dosage amount of the liquid medicament within the cartridge 110 to the atomization subassembly 130.

[0097] As best shown in the exploded view of FIG. 4 and in FIG. 6, which is an enlarged view of the atomization subassembly 130 of FIGS. 5 A and 5B, the atomization subassembly 130 includes a large union nut 132, a small union nut 134, a washer 136, a micro-structured nozzle 138, a nozzle seal 140, a nozzle holder 142, a pre-fdter 144, a pre-fdter holder 146, a central tube 148 having the metering chamber 145 formed therein, and one or more O-rings 149. The atomization subassembly 130 is configured to aerosolize the liquid medicament conveyed into the metering chamber 145 by the compression subassembly 111. The aerosolization process is initiated when a user depresses the trigger 108. When the trigger 108 is depressed, the spring 126 is released from the compressed state and permitted to return to a lower compressed state. When the spring 126 is released, a force pushes the liquid medicament which is residing within the capillary tube 124 through the pre-filter 144 and the micro-structured nozzle 138. The pre-filter 144 is used to filter out or hold back any larger particles which can clog downstream flowing of the liquid medicament through the micro-structured nozzle 138. After passing through the pre-filter 144, the liquid medicament passes through the micro- structured nozzle 138 for aerosolization. The microstructured nozzle 138 is configured to produce an aerosol having a desired particle size in a controlled and precise delivery manner. The aerosolized liquid medicament then exits the inhaler 100 via the mouthpiece 105 for patient inhalation.

[0098] For insertion and / or replacement of the cartridge 110, the lower casing 106 is detachable from the upper casing 104. When the lower casing 106 is removed or detached from the upper casing 104, the cartridge 110 is securely connected to the capillary holder 120 in a snap-fit manner by being received within retention arms 121A, 121B of the capillary holder 120. When being attached to the capillary holder 120, the capillary tube 124 pierces into the sealed cartridge 110 such that the bore of the capillary tube 124 is in fluid communication with the interior of the cartridge 110 that contains the liquid medicament to be delivered via inhaler 100.

[0099] Priming of the inhaler 100 will now be described in more detail. During priming, as shown in the side sectional view of FIG. 11A, the cap 102 should be moved into its closed configuration to prevent accidental pressing of trigger 108. FIG. 11A illustrates the initial or start position of the internal components of the inhaler 100 prior to priming.

[0100] To prime the inhaler 100, the lower casing 106 is rotated approximately 180 degrees until it clicks into place. The inhaler 100 is primed before each dose of liquid medicament can be delivered. The inhaler 100 undergoes four stages during priming, i.e., during rotation of the lower casing 106, relative to the upper casing 104. The four stages include (1) metering chamber filling; (2) cartridge piercing; (3) trigger protrusion; and (4) lockout. At the conclusion of these four stages, the inhaler 100 is considered primed and a dose of the liquid medicament is drawn up from the cartridge 110 via the capillary tube 124, ready to be atomized.

[0101] The lower casing 106, the driving tube 114, the capillary holder 120, and the cartridge 110 are rotationally constrained to each other, and thus rotate concurrently as an assembly. Thus, when the lower casing 106 is rotated during priming, the driving tube 114 and the capillary holder 120 rotate as well. When cartridge 110 is inserted into the inhaler 100, it is locked to the capillary holder 120 in a snap-fit manner. In the first stage of priming, i.e., metering chamber filling, the capillary holder 120 rides along a helical ramp 180 (shown on FIGS. 29, 30, and 31) formed on a bottom facing surface of the upper casing 104, which forces or guides the capillary holder 120 axially downwards, i.e., in a direction away from the cap 102 of the inhaler. The positioning of the internal components at the first stage of priming is illustrated in the side sectional view of FIG.11B. As the capillary holder 120 and the capillary tube 124 attached thereto moves axially downwards, the capillary holder 120 contacts and longitudinally compresses the spring 126. The capillary tube 124 and the valve body 122 attached thereto are slidingly disposed within an axial lumen 147 of the central tube 148 and is permitted to move in an axial direction therethrough. Thus, as the capillary tube 124 moves axially downwards through the longitudinal or axial lumen 147 formed through the central tube 148, the metering chamber 145 of the central tube 148 expands, thereby decreasing the pressure in the metering chamber 145 of the central tube 148. The metering chamber 145 is the portion of the axial lumen 147 extending between the valve body 122 and the pre-filter 144. Since the valve body 122 moves during the priming operation of the inhaler 100, the volume of the metering chamber 145 is variable. When the pressure within the metering chamber 145 decreases due to the downward movement of the valve body 122 and capillary tube 124, the valve body 122 is caused to open and liquid medicament is drawn up from the cartridge 110 and into the metering chamber 145 via the capillary tube 124. More particularly, the valve body 122 is provided with an opening, groove, recess, or the like (not shown) that is configured to open and close in response to pressure changes within the metering chamber 145.

[0102] As the capillary holder 120 moves axially downwards, the cartridge 110 attached thereto is concurrently moving axially downwards as well. The second stage of priming, i.e., cartridge piercing, occurs when the bottom of the cartridge 110 contacts or comes into interference with a piercing element 107 which is disposed at the bottom of the lower casing 106. The positioning of the internal components at the second stage of priming is illustrated in the side sectional views of FIG. 11C and FIG. 12. The piercing element 107 pierces a foil cover of the cartridge 110, providing an airway for pressure release in the cartridge 110 to permit ventilation and allowing the internal bag within the cartridge 110 (which holds the liquid medicament) to collapse as it empties. After the initial prime operation of the inhaler 100, the stage of cartridge piercing is no longer performed because the cartridge 110 is only pierced during the initial prime operation. However, after the first prime operation, the piercing element 107 ensures that the cartridge 110 does not become blocked by debris during the lifetime of the inhaler 100.

[0103] An enlarged view of the placement of the stop ring 112 at the second stage of priming is illustrated in the side sectional view of FIG. 12. The stop ring 112 is an annular component having an inner diameter that defines an opening 113 therethrough. The inner diameter is greater than an outer diameter of the capillary holder 120 such that the capillary holder 120 can pass through the opening 113 of the stop ring 112 when the stop ring 112 and the capillary holder 120 are concentrically aligned. At this stage of the priming operation, a top surface 150 of the capillary holder 120 is disposed below a bottom surface 160 of the stop ring 112 and the capillary holder 120 is disposed approximately or substantially concentrically within the stop ring 112. This position, in which the stop ring 112 and the capillary holder 120 are concentrically aligned, is a first position of the stop ring 112.

[0104] The third stage of priming, i.e., trigger protrusion, occurs when the capillary holder 120 reaches the end of the helical ramp 180 on the upper casing 104. The positioning of the internal components at the third stage of priming is illustrated in the side sectional views of FIG. 1 ID and FIG. 13. When the capillary holder 120 reaches the end of the helical ramp 180 on the upper casing 104, cam features (not shown) on the driving tube 114 force or push the stop ring 112 in a lateral direction, and the lateral movement or shifting of the stop ring 112 displaces the stop ring 112 so as to overlap or overlay the capillary holder 120 as best shown in FIG. 13. Thus, the capillary holder 120 abuts against the stop ring 112 when the stop ring 112 is laterally displaced. Thecapillary holder 120 is no longer concentrically positioned within the stop ring 112, because the stop ring 112 has been shifted laterally to block further upwards movement of the capillary holder 120. The stop ring 112 thus operates or functions to block or stop axially upwards movement of the capillary holder 120 and thereby maintain the spring 126 in the compressed state until the user is ready to release the dose. This position, in which the stop ring 112 and the capillary holder 120 are not concentrically aligned, is a second position of the stop ring 112. The stop ring 112 is therefore displaceable between the first position of FIG. 12 in which the stop ring 112 and the capillary holder 120 are concentrically aligned and the second position of FIG. 13 in which the stop ring 112 is laterally shifted to partially overlap the capillary holder 120. The stop ring 112 is configured to block axial upwards movement of the capillary holder 120 when in the second position to maintain the spring 126 in the compressed state. Further, lateral movement or shifting of the stop ring 112 pushes or forces the trigger 108 laterally or radially outward such that the trigger 108 protrudes laterally from an opening of the upper casing 104, as also apparent in FIG.13 when the stop ring 112 is in the second position. In an embodiment, the trigger 108 is integrally formed on the stop ring 112. In another embodiment, trigger 108 is connected and / or fastened to stop ring 112.

[0105] The fourth stage of priming, i.e., lockout, occurs when the capillary holder 120 is rotated past or beyond the end of the helical ramp 180 on the upper casing 104. The positioning of the internal components at the fourth and final stage of priming is illustrated in the side sectional view of FIG. HE. When the capillary holder 120 is no longer guided by the helical ramp 180, it is moved axially upwards, i.e., in a direction towards the cap 102, by the spring 126 until it is restrained axially against the stop ring 112 and the upper casing 104. As the capillary holder 120 moves axially upwards, the capillary tube 124 attached thereto also moves axially upwards, thereby slightly contracting the size of the metering chamber 145 and increasing the pressure within the metering chamber 145. When the pressure within the metering chamber 145 increases, the valve body 122 is caused to close. After the valve body 122 is closed, a predetermined amount or dose of the liquid medicament is enclosed or contained within the metering chamber 145. This dose of the liquid medicament is ready to be atomized by the atomization subassembly 130. Thus, at the conclusion of priming, the spring 126 is charged and the metering chamber 145 is full of liquid medicament ready for delivery of the dose.

[0106] Actuation of the inhaler 100 will now be described in more detail. Prior to releasing the dose of the liquid medicament, the cap 102 should be positioned in its open configuration (shown in FIG. 2) to expose the trigger 108 and the mouthpiece 105. To release the dose, the trigger 108 is pressed laterally or radially inwards by a user. The lateral movement of the trigger 108 pushes the stop ring 112 laterally or radially inwards, thereby repositioning or shifting the stop ring 112 such that it no longer overlaps or overlays the capillary holder 120 and rather resumes the concentric positioning of FIG. 15. Thus, the capillary holder 120 no longer abuts against the stop ring 112 and the capillary holder 120 is permitted to pass through the opening 113 of the stop ring 112. Without the stop ring 112 blocking or stopping axially upwards movement of the capillary holder 120, the spring 126 is no longer constrained and is permitted to resume or revert to its original configuration. The capillary holder 120 is moved axially upwards, i.e., in a direction towards the cap 102, by the spring 126. The capillary tube 124 compresses the liquid medicament in the disposed within the metering chamber 145. Since the valve body 122 is closed, the liquid medicament is forced through the atomization subassembly 130. As the liquid medicament is forced through the pre-filter 144 and the micro- structured nozzle 138, in particular, the liquid medicament is aerosolized and the aerosolized liquid medicament then exits the inhaler 100 via the mouthpiece 105 for patient inhalation. Due to the spring 126 resuming or reverting back to its unloaded configuration, the liquid medicament is forced through the pre-filter 144 and the microstructured nozzle 138 to be atomized into an inhalable aerosol. After the dose is released, the cap 102 should be moved into its closed configuration to prevent accidental pressing of trigger 108 during priming of the next dose.

[0107] To function correctly, the atomization subassembly 130 of the inhaler 100 is rigidly and robustly retained within the upper casing 104 to ensure that the metering chamber 145 correctly meters the dose of liquid medicament that is delivered in each dose. The connection joint between the atomization subassembly 130 and the upper casing 104 is subjected to significant loads during use, both when priming and particularly when delivering the dose. Thus, the connection between the atomization subassembly 130 and the upper casing 104 are designed so that the components have minimal movement or, ideally, no movement relative to each other when subjected to these loads. While it is possible to retain the atomization subassembly 130 within the upper casing 104 via a diametrical interference fit, the strength of the connection joint is subject to manufacturing tolerances of the interface features. This rigid interference fit connection between the atomizationsubassembly 130 and the upper casing 104, necessitates very precise control of manufacturing tolerances. In mass production, such precision can result in an unacceptably high failure rate of inhaler units that do not meet quality control standards. To address this failure rate, with reference to FIGS. 7-10, the inhaler 100 includes a plurality of retention pads 184 disposed on ribs 185 of the central tube 148 that are configured to contact an inner surface of the upper casing 104 and improve retention of the atomization subassembly 130 within the upper casing 104.

[0108] More particularly, as best shown on the top view of FIG. 8, the central tube 148 includes four ribs 185 spaced around the circumference of the central tube 148 and extending radially outward. In some embodiments, central tube 148 can include three ribs 185 spaced around the circumference of the central tube 148 and extending radially outward. The ribs 185 can be equally spaced around the circumference of the central tube 148 in some embodiments. A retention pad 184 is formed on each rib 185 on an outermost facing surface of each rib 185 that will contact the inner surface of the upper casing 104 when the central tube 148 is assembled in the upper casing 104. The retention pad 184 has an inclined outer surface 186 that is configured to contact an inner surface of the upper casing 104. The inclined outer surface 186 flares radially outward in the downward direction, i.e., away from the cap 102, such that the bottom end of the inclined outer surface 186 is a sharp edge 187. The inclined outer surface 186 is not parallel to the longitudinal axis of the inhaler, but rather flares radially outward from the top end to the bottom end thereof. Stated another way, each retention pad 184 can have a variable thickness that increases from the top end to the bottom end thereof. The sharp edge 187 at the bottom end of the inclined outer surface 186 can extend substantially perpendicular to the longitudinal axis of the inhaler. In an embodiment, the retention pads 184 are integrally formed on the central tube 148. For example, the retention pads 184 can be integrally formed on the central tube 148 via separate inserts in a molding tool (not shown) that is used to form the central tube 148. In an embodiment, the central tube 148 is formed from a first polymer material and the upper casing 104 is formed from a second polymer material. The first polymer material of the central tube 148 is harder than the second polymer material. In an embodiment, the first polymer material is a poly aryl etherketone polymer such as polyether ether ketone (PEEK), and the second polymer material is acrylonitrile butadiene styrene (ABS). However, it is noted that these are exemplary polymers and that other polymers known in the art can also be used. The sharp edges 187 of the retention pads 184, formed from the harder first polymer material, are configured to bite into firm engagement with the softer secondpolymer of the upper casing 104. As such, the retention pads 184 provide a secure and robust joint between the atomization subassembly 130 and the upper casing 104 that remains rigid and stationary under operating loads.

[0109] As apparent from the priming and actuation descriptions above, the stop ring 112 is responsible for retaining the capillary holder 120 securely so that the spring 126 is not released inadvertently or prematurely during the priming operation. As described above, since the capillary holder 120 must pass though the opening 113 in the stop ring 112 to dispense a dose, the outer diameter of capillary holder 120 must be less than the inner diameter of the stop ring 112. Thus, the larger inner diameter of the stop ring 112 relative to the smaller outer diameter capillary holder 120 means that when the stop ring 112 in the second position engages the capillary holder 120, the load from the spring 126 is carried predominantly on one side of the capillary holder 120 and the stop ring 112, making the system inherently unstable. As a result, the trigger mechanism is very susceptible to tolerances and frictional variations, which can cause inadvertent or premature actuation of the inhaler 100 as the spring load is transferred to the stop ring 112 during the third stage of the priming operation described above.

[0110] Disclosed herein are several embodiments, which can be used individually or in combination, to increase the robustness and reliability of the inhaler 100. The embodiments described herein include features on the capillary holder 120, the stop ring 112, and / or the upper casing 104 which can result in a stable load transfer mechanism that is tolerant to variations in part geometry and surface finishes. These features are intended to make the engagement of the capillary holder 120, the stop ring 112, and / or the upper casing 104 under load more stable, 108 as the spring load is transferred to the stop ring 112.

[0111] FIGS. 14-24 disclose an embodiment that can increase the robustness and reliability of the inhaler 100. As will be described in more detail herein, the stop ring 112 includes two diametrically opposed upwardly-extending steps 170, each of which is configured to longitudinally space apart a portion of the bottom surface 160 of the stop ring 112 from the top surface 150 of the capillary holder 120 to create a gap which prevents contact therebetween. By preventing contact between particular portions of the stop ring 112 and the capillary holder 120,the upwardly-extending steps 170 prevent the capillary holder 120 from tilting relative to the stop ring 112.

[0112] More particularly, since the the load from the spring 126 is carried predominantly on one side of the capillary holder 120 and the stop ring 112 as described above, there is a tendency for the capillary holder 120 to tilt relative to the stop ring 112. This tilt creates a lateral force on the stop ring 112 from the capillary holder 120, which acts like a wedge, pushing the stop ring 112 towards an actuated position. Stated differently, this lateral force increases the robustness of the trigger 108 because the majority of the spring load is passing through the two diametrically opposed “scissor” points where the stop ring 112 is partially overlapping the capillary holder 120, but beginning to radially extend past the capillary holder 120 due to the greater size of the stop ring 112. At the “scissor” points, a radial gap opens up where the stop ring 112 is beginning to radially extend past the capillary holder 120 to the greater size of the stop ring 112. Due to imbalanced loads, the capillary holder 120 has a tendency to rotate inside the driving tube 114 which is herein referred to as a “scissoring effect”. The upwardly-extending steps 170 of the stop ring 112 prevent this scissoring effect by preventing any load being applied between the contact faces at the diametrically opposed “scissor” points.

[0113] The mating relationship between the top surface 150 of the capillary holder 120 and the bottom surface 160 of the stop ring 112 that results from the addition of the upwardly -extendi ng steps 170 will now be described in more detail. FIGS. 14-16 illustrate the first position of the stop ring 112 in more detail. FIGS. 14, 15, and 16 are perspective, top, and side views of the stop ring 112, the trigger 108 attached to the stop ring 112, and the capillary holder 120 when the stop ring 112 is in the first position, with the components being shown removed from the inhaler 100 for sake of illustration only. As clearly shown on the top view of FIG. 15, the stop ring 112 and the capillary holder 120 are concentrically aligned when the stop ring 112 is in the first position, and the inner diameter of the stop ring 112 is greater than an outer diameter of the capillary holder 120 such that the capillary holder 120 can pass through the opening 113 of the stop ring 112.

[0114] FIGS. 17-20A illustrate the second position of the stop ring 112 in more detail. FIGS.17, 18, and 19 are perspective, top, and side views of the stop ring 112, the trigger 108 attached to the stop ring 112, and the capillary holder 120 when the stop ring 112 is in the second position,with the components being shown removed from the inhaler 100 for sake of illustration only. FIG.20 is also a top view of the stop ring 112, the trigger 108 attached to the stop ring 112, and the capillary holder 120 when the stop ring 112 is in the second position, except that FIG. 20 depicts the stop ring 112 in phantom to clearly illustrate the radial overlap between the stop ring 112 and the capillary holder 120 when the stop ring 112 is in the second position. FIG. 20A is a schematic illustration of a top view of the radial overlapping region between the stop ring 112 and the capillary holder 120 when the stop ring 112 is in the second position. FIG. 21 illustrates a bottom view of the stop ring 112 and the trigger 108 only to clearly illustrate the bottom surface 160, while FIG. 22 illustrates a top view of the capillary holder 120 only to clearly illustrate the top surface 150. When the stop ring 112 is in the second position, a portion of the bottom surface 160 of the stop ring 112 radially overlaps a portion of the top surface 150 of the capillary holder 120. Since the inner diameter of stop ring 112 is larger than the outer diameter of capillary holder 120, only one side or end of the stop ring 112 overlaps the capillary holder 120 when the stop ring 112 is displaced into its second position.

[0115] More particularly, when the stop ring 112 is in the second position, the top surface 150 of the capillary holder 120 includes an overlapping portion 152 and a non-overlapping portion 154 as best shown on FIG. 20. The overlapping portion 152 and the non-overlapping portion 154 of the top surface 150 of the capillary holder 120 collectively extend around an entire circumference of the capillary holder 120. Similarly, the bottom surface 160 of the stop ring 112 includes an overlapping portion 162 and a non-overlapping portion 164. The overlapping portion 162 and the non-overlapping portion 164 of the bottom surface 160 of the stop ring 112 collectively extend around an entire circumference of the stop ring 112. As previously described, due to the required size differential between the inner diameter of stop ring 112 and the outer diameter of capillary holder 120, only one side or end of the stop ring 112 overlaps the capillary holder 120 when the stop ring 112 is displaced into its second position. The respective overlapping portions 152, 162 overlap or overlay each other when the stop ring 112 is shifted from the first position to the second position. Stated differently, the respective overlapping portions 152, 162 are radially aligned with each other when the stop ring 112 is in the second position. The respective non-overlapping portions 154, 164 do not overlap when the stop ring 112 is shifted from the first position to the second position. Stated another way, the respective overlapping portions 152, 162 are radially offset from each other when the stop ring 112 is in the second position.

[0116] As best shown on FIGS. 20 and 20 A, due to the presence of two upwardly -extendi ng steps 170, the respective overlapping portions 152, 162 of the capillary holder 120 and the stop ring 112, respectively, each include sections which contact each other and sections that do not contact each other. More particularly, the respective overlapping portions 152, 162 of the capillary holder 120 and the stop ring 112, respectively, have a crescent shape. Without the presence of two upwardly-extending steps 170, the full crescent shape of the respective overlapping portions 152, 162 of the capillary holder 120 and the stop ring 112, respectively, would contact each other. However, the two upwardly-extending steps 170 effectively raise the bottom surface 160 of the stop ring 112 such that the end portions of the crescent shape do not contact the top surface 150 of the capillary holder 120. Thus, even though the end portions of the crescent shape radially overlap, such portions have a longitudinal gap or space therebetween that prevent contact therebetween. The placement or location of the upwardly-extending steps 170 is shown in phantom on FIG. 20A.

[0117] More particularly, the overlapping portion 152 of the capillary holder 120 includes a contact section 156 and two non-contact sections 158. The contact section 156 is disposed between the two non-contact sections 158. Collectively, the contact section 156 and the two non-contact sections 158 constitute or make up the entire area of the overlapping portion 152 of the capillary holder 120. Similarly, the overlapping portion 162 of the stop ring 112 includes a contact section 166 and two non-contact sections 168. The contact section 166 is disposed between the two noncontact sections 168. Collectively, the contact section 166 and the two non-contact sections 168 constitute or make up the entire area of the overlapping portion 162 of the stop ring 112. The contact section 156 of the capillary holder 120 is in contact with or abuts against the contact section 166 of the stop ring 112 when the stop ring 112 is in the second position.

[0118] An upwardly-extending step 170 is disposed between each intersection or joint of the contact section 166 of the overlapping portion 162 of the bottom surface 160 of the stop ring 112 and a non-contact section 168 of the overlapping portion 162 of the bottom surface 160 of the stop ring 112. As a result of the upwardly-extending steps 170, the non-contact sections 158 of the capillary holder 120 are longitudinally spaced apart from the non-contact sections 168 of the stop ring 112 when the stop ring 112 is in the second position. The upwardly-extending steps 170 are configured to longitudinally offset the non-contact sections 168 of the overlapping portion 162 of the stop ring 112 from the top surface 150 of the capillary holder 120 to create a gap which preventscontact therebetween. Thus, when the stop ring 112 is in the second position, the contact section 166 of the overlapping portion 162 of the stop ring 112 contacts the top surface 150 of the capillary holder 120 while the non-contact sections 168 of the overlapping portion 162 of the stop ring 112 does not contact the top surface 150 of the capillary holder 120. The non-contact sections 168 correspond to the two diametrically opposed “scissor” points described above, and the upwardly-extending steps 170 of the stop ring 112 prevent the above-described scissoring effect by preventing any load being applied between the non-contact sections 158, 168 of the overlapping portions 152, 162 of the capillary holder 120 and the stop ring 112, respectively.

[0119] Each upwardly-extending step 170 extends at an oblique angle with respect to the contact section 166 of the overlapping portion 162 of the stop ring 112. Since the mating relationship between the top surface 150 of the capillary holder 120 and the bottom surface 160 of the stop ring 112 results in two diametrically opposed “scissor” points where the stop ring 112 is partially overlapping the capillary holder 120, the stop ring 112 preferably includes diametrically opposed upwardly-extending steps 170. Each upwardly-extending step 170 is disposed between the contact section 166 of the overlapping portion 162 of the stop ring 112 and one of the two noncontact sections 168 of the overlapping portion 162 of the stop ring 112. Further, each upwardly-extending step 170 is configured to longitudinally space apart one of the two non-contact sections 168 of the overlapping portion 162 of the stop ring 112 from the top surface 150 of the capillary holder 120 to create a gap which prevents contact therebetween. However, it is possible that the presence of only a single upwardly-extending step 170 will reduce the tendency of the capillary holder 120 to rotate, and thus, in another embodiment, the stop ring 112 can include only a single upwardly-extending step 170 between the contact section 166 of the overlapping portion 162 of the stop ring 112 and one of the two non-contact sections 168 of the overlapping portion 162 of the stop ring 112.

[0120] A second embodiment to increase the robustness and reliability of inhaler 100 is depicted in FIGS. 25-27. FIG. 25 is an enlarged perspective view of portions of the stop ring 112 and the capillary holder 120 of the inhaler 100 when the stop ring 112 is in the second position, with the components shown removed from the inhaler 100 for sake of illustration only. FIG. 26 is an enlarged bottom view of a portion of the stop ring 112, and FIG. 27 is an enlarged top view of a portion of the capillary holder 120. As shown on these figures, the bottom surface 160 of thestop ring 112 includes a protrusion 182 extending from the contact section 166 of the overlapping portion 162 of the stop ring 112. The protrusion 182 extends in a radially outward direction and is configured to increase the amount of radial overlap between the contact sections 156, 166 of the capillary holder 120 and the stop ring 112, respectively. Stated another way, the contact section 166 of the overlapping portion 162 of the stop ring 112 contacts the top surface 150 of the capillary holder 120 when the stop ring 112 is in the second position and the protrusion 182 is configured to maximize the area or amount of the contact between these surfaces. By maximizing the amount of contact between these two surfaces at the contact sections 156, 166, the protrusion 182 improves the robustness to accidental or premature firing of the inhaler 100. In an embodiment, the protrusion 182 extends between 2% and 4% of a circumference of the stop ring 112. In an embodiment, the protrusion 182 has a circumferential length CL that extends between 1% and 5% of a circumference of the stop ring 112.

[0121] The protrusion 182 has a radial width Wi, while the capillary holder 120 has a radial width W2. In an embodiment, the radial width Wi is twice (or 100% greater than) the radial width W2. In another embodiment, the radial width Wi is between 15% and 125%, 20% and 125%, 25% and 125%, 30% and 125%, 35% and 125%, 40% and 125%, 45% and 125%, 50% and 125%, 55% and 125%, 60% and 125%, 65% and 125%, 70% and 125%, 75% and 125%, 80% and 125%, 85% and 125%, 90% and 125%, 95% and 125%, 100% and 125%, 15% and 115%, 15% and 110%, 15% and 105%, 15% and 100%, 15% and 95%, 15% and 90%, 15% and 85%, 15% and 80%, 15% and 75%, 15% and 70%, 15% and 65%, 15% and 60%, 15% and 55%, 15% and 50%, 15% and 45%, 15% and 40%, 15% and 35%, 15% and 30%, 15% and 25%, 20% and 120%, 25% and 115%, 30% and 110%, 35% and 105%, 40% and 100%, 45% and 95%, 50% and 90%, 55% and 85%, or 60% and 80% greater than the radial width W2. When compared to the radial width W3, which is a radial width of the bottom surface 160 of the stop ring 112 adjacent to the protrusion 182, the radial width Wi is between 100% and 175% greater than the radial width W3.

[0122] A third embodiment to increase the robustness and reliability of inhaler 100 is depicted in FIGS. 28-31. FIGS. 28 and 30 are perspective views of the upper casing 104 shown removed from the inhaler 100 for sake of illustration only, and FIG. 29 is a bottom view of the upper casing 104. FIG. 31 is a perspective sectional view of the stop ring 112, the capillary holder 120, and the upper casing 104 of the inhaler 100 when the stop ring 112 is in the second position, with thecomponents shown removed from the inhaler 100 for sake of illustration only. As shown on these figures, the upper casing 104 includes at least one ramp 172 configured to interact with the stop ring 112. The ramp 172 is configured or designed to resist, but not prevent, movement of the stop ring 112 from the second position (of FIG. 13) to the first position (of FIG. 12). As the stop ring 112 contacts ramp 172, the stop ring 112 is moved in an axially downward direction to further compress the spring 126. This additional work resists the accidental or premature actuation of trigger 108, unless the user actively presses on the trigger 108 to overcome this resistance and thereby dispense the liquid medicament to deliver a dose.

[0123] The mating relationship between the stop ring 112 and the upper casing 104 will now be described in more detail. The upper casing 104 defines a compartment 174 between a first interior surface 176 and a second interior surface 178, and the stop ring 112 and at least a portion of the capillary holder 120 is disposed within the compartment 174. The first interior surface 176 of the upper casing 104 includes the helical ramp 180 configured to interact with the capillary holder 120 and the second interior surface 178 of the upper casing 104 includes the at least one ramp 172 configured to interact with the stop ring 112. The ramp 172 is configured to resist but not prevent movement of the stop ring 112 when the stop ring 112 is moved in the direction from the second position (of FIG. 13) to the first position (of FIG. 12). As shown in at least FIGS. 30 and 31, helical ramp 180 can be formed as a series of steps of increasing height, or, alternatively, as a continuous surface.

[0124] The ramp 172 extends at an acute angle with respect to a plane transverse to a longitudinal axis of the inhaler 100. In an embodiment, the ramp 172 extends at an acute angle between 10 and 30 degrees with respect to a plane transverse to a longitudinal axis of the inhaler 100. In another embodiment, the ramp 172 extends at an acute angle between 15 and 25 degrees with respect to a plane transverse to a longitudinal axis of the inhaler 100. The ramp 172 is configured to urge the stop ring 112 in an axially downward direction when the stop ring 112 moves in the direction from the second position (of FIG. 13) to the first position (of FIG. 12). The angle of the ramp 172 is configured to resist but not prevent movement of the stop ring 112 when the stop ring 112 is moved in the direction from the second position (of FIG. 13) to the first position (of FIG. 12).

[0125] In an embodiment, the second interior surface 178 of the upper casing 104 includes two ramps 172 and each ramp 172 is configured to interact with the stop ring 112. As shown on FIGS.29, 30, and 31, the two ramps can include a first ramp 172A and a second ramp 172B. The first ramp 172 A is disposed between 60 and 120 degrees away from the second ramp 172B. In an embodiment, the first ramp 172A is disposed between 80 and 100 degrees away from the second ramp 172B. The resistance load can be more balanced in some cases by including two ramps 172 at circumferentially spaced apart positions on the second interior surface 178. The first and second ramps 172A, 172B are generally diametrically opposed to the trigger 108. In another embodiment, a single ramp 172 can be disposed on the second interior surface 178 and the single ramp 172 can be generally diametrically opposed to the trigger 108.

[0126] Turning now to FIG. 32, another advantageous feature of the inhaler 100 will be described. The upper and lower casings 104, 106 of the inhaler 100 each have a substantially oval or elliptical cross-section rather than circular, as known in other inhalers of this type. To create an improved user experience, it is advantageous to provide the inhaler 100 with an elliptical-shaped external form. The above-described priming operation for the inhaler 100 requires the user to rotate the lower casing 106 by 180 degrees relative to the upper casing 104, overcoming force exerted by the relatively stiff spring 126. Inhalers with a largely circular external cross-sectional form are more difficult for users to grip when priming the device and provide less clear indication of when the device is correctly primed and ready to deliver a dose. In contrast, the elliptical-shaped external form of the inhaler 100 enables the user to more easily apply the torque needed to perform the priming operation and to allow the user to easily recognise and understand when the inhaler 100 is correctly primed after the lower casing 106 has been rotated by 180 degrees relative to the upper casing 104 (i.e., the inhaler 100 has the elliptical-shaped external form when the upper and lower casings 104, 106 are aligned). Further, the elliptical-shaped external form of the inhaler 100 is easier for a user to hold and manipulate in use relative to an inhaler having a circular external form.

[0127] The inhaler 100 incorporates interface features between the upper casing 104 and the driving tube 114 which enable the upper and lower casings 104, 106 of the inhaler 100 to have a substantially oval or elliptical cross-section rather than circular. FIG. 32 is a sectional view of the upper casing 104 and the driving tube 114, with these components removed from the inhaler 100for sake of illustration only. The second interior surface 178 of the upper casing 104 (described above with respect to FIGS. 29-31) includes a discontinuous pair of snap features 188A, 188B that are configured to be received within a continuous groove 190 formed on an outer surface 115 of the driving tube 114. The outer surface 115 of the driving tube 114 is substantially cylindrical, while the second interior surface 178 of the upper casing 104 is substantially elliptical. Each of the snap features 188 A, 188B is profiled so that during assembly of the inhaler 100, the inner surfaces of snap features 188A, 188B become curved and correspond to the curvature of the outer surface 115 of the driving tube 114 within the groove 190. Stated another way, inner surfaces of snap features 188 A, 188B stretch and / or deform so as to be concentric the outer surface 115 of the driving tube 114 within the groove 190. The snap features 188A, 188B are diametrically opposed to each other, and are substantially aligned along a minor axis of the elliptical cross-section.

[0128] The second interior surface 178 of the upper casing 104 also includes a pair of crush ribs 192A, 192B that are configured to abut against the outer surface 115 of the driving tube 114. The driving tube 114 must be permitted to rotate relative to the upper casing 104 during priming. The crush ribs 192A, 192B are diametrically opposed to each other, and are substantially aligned along a major axis of the elliptical cross-section. Further, the crush ribs 192A, 192B are approximately perpendicular to the snap features 188A, 188B. The crush ribs 192A, 192B ensure that the driving tube 114 is securely held from moving along the major axis of the elliptical crosssection and the snap features 188A, 188B prevent movement along the minor axis of the elliptical cross-section. The crush ribs 192A, 192B are configured to abut against the outer surface 115 of the driving tube 114 in a slight interference fit in the nominal condition of components to help ensure good retention even when components are at minimal material condition (i.e., the driving tube 114 is at a minimum diametrical tolerance and the upper casing 104 is at a maximum diametrical tolerance). By “slight” interference fit, as used herein, the fit between the components allowed for the driving tube 114 to rotate relative to the upper casing 104 but also abut against each other to ensure that the driving tube 114 is securely held from moving along the major axis of the elliptical cross-section. At the opposite tolerance condition where the fits are much tighter, the crush ribs 192A, 192B are configured to plastically deform slightly during assembly so that after assembly the crush ribs 192A, 192B and the driving tube 114 are in reasonably close but slight interference fit. In this way, after assembly for all tolerance combinations, the driving tube 114 is constrained to rotate concentrically within the upper casing 104 with minimal off axis drift.The interface features between the upper casing 104 and the driving tube 114 also result in good radial alignment of the upper and lower casings 104, 106 before and after priming.

[0129] As stated above, the snap features 188A, 188B are diametrically opposed to each other. This configuration results in circumferential spaces or gaps 194A, 194B between the snap features. When the driving tube 114 rotates within the upper casing 104 during priming, the spindle 118 is disposed along these circumferential spaces or gaps 194A, 194B. One potential issue with such circumferential spaces of gaps 194A, 194B is that if the lower casing 106 is removed during priming when the spindle 118 is disposed within one of the circumferential gaps 194 A, 194B, the user would have access to the spindle 118 and could potentially rotate the spindle 118 by hand, thereby incrementing or decrementing the counter without operating the inhaler. To address this potential issue, the spindle 118 and the driving tube 114 include mating surfaces 196, 198, respectively, that create a strong detent between the two components so that if the lower casing 106 is removed during priming, a user cannot rotate the spindle 118 out of this detent position with finger contact alone. Thus, the detent created by the mating surfaces 196, 198 prevents users from incrementing or decrementing the counter without operating the inhaler 100.

[0130] Before describing the detent created by the mating surfaces 196, 198 in more detail, the operation of the counter of the inhaler 100 will be briefly described. With reference to the sectional view of FIG. 5A, as well as FIGS. 33-35, the inhaler 100 includes the rider 119 which indicates the doses remaining within the inhaler 100 by pointing at a scale visible through the transparent lower casing 106 on the driving tube 114. The rider 119 is threaded to the spindle 118 but is constrained rotationally. Therefore, as the spindle 118 rotates, the rider 119 moves axially upwards. The spindle 118 rotates through 180° when its gear teeth 199 (disposed at a first or top end of the spindle 118) meet gear teeth 197 formed on the second interior surface 178 of the upper casing 104, as best shown on the cross-sectional view of FIG. 35 which illustrates only the spindle 118 and the upper casing 104 for sake of illustration only. Each time the gear teeth 199 of the spindle 118 contact the gear teeth 197 of the upper casing 104, the spindle 118 rotates 180 degrees and the rider 119 is axially translated upwards up a fixed amount. The gear teeth 197 on the upper casing 104 are positioned so the spindle 118 is rotated one full rotation by the end of the priming operation or rotation.

[0131] Turning now to the perspective sectional views of FIGS. 36A and 36B, the potential issue with circumferential spaces of gaps 194A, 194B can be clearly shown. When the spindle 118 is adjacent to the snap feature 188A or snap feature 188B, the gear teeth 197 of the upper casing 104 prevent or restrain rotation of the spindle 118 as shown on FIG. 36A. Thus, even if the lower casing 106 is removed during priming when the spindle 118 is disposed at this location, the user cannot increment or decrement the counter (i.e., the rider 119) by hand. However, when the spindle 118 moves circumferentially beyond the snap feature 188 A or snap feature 188B and are disposed within one of circumferential spaces of gaps 194 A, 194B, the user can possibly increment or decrement the counter (i.e., the rider 119) by hand.

[0132] To address this issue, as stated above, the driving tube 114 and the spindle 118 include mating surfaces 196, 198, respectively, that create a strong detent between the two components so that if the lower casing 106 is removed during priming, a user cannot rotate the spindle 118 out of this detent position with finger contact alone. The mating surfaces 196, 198 of the driving tube 114 and the spindle 118, respectively, are best shown in FIGS. 37-39. FIGS. 37 and 38 are enlarged perspective sectional views, while FIG. 19 is a cross-sectional view which illustrates only the spindle 118 and the driving tube 114 for sake of illustration only. The mating surfaces 196, 198 of the driving tube 114 and the spindle 118, respectively, are configured to abut against or contact each other to form a detent. The mating surfaces 196, 198 are angled and configured to provide resistance to rotation of the spindle 118 relative to the driving tube 114 by hand alone. Thus, the detent created by the mating surfaces 196, 198 prevents users from incrementing or decrementing the counter without operating the inhaler 100. However, the detent created by the mating surfaces 196, 198 is overcome during normal operation of the inhaler 100 when the spindle 118 is rotated via meeting between the gear teeth 199 of the spindle 118 and the gear teeth 197 of the upper casing 104.

[0133] In embodiments described here, liquid medicament to be delivered via inhaler 100 can comprise an active pharmaceutical ingredient (“API”) related to treating, curing, and / or controlling respiratory diseases or conditions. In some embodiments, the liquid medicament to be delivered via inhaler 100 can comprise an API related to treating, curing, and / or controlling non-respiratory diseases or conditions. The API-containing liquid medicament can be stored in cartridge 110 and be dispersed as an aerosol from inhaler 100 as described here. In some instances, the API cancomprise a beta-mimetic, an anticholinergic, a vasodilator / bronchodilator, a corticosteroid, aPDE inhibitor, a leukotriene antagonist, an EGFR-inhibitor, an Hl, H2, and / or H3 -antihistamine, a PAF antagonist, a PI3 kinase inhibitor, GPL-1 agonists, a non-prostanoid prostacyclin receptor agonist, an antifibrotic, an antifungal, an antibiotic, an antiviral, an anti-tumor agent, an anti-inflammatory, mRNA, siRNA or DNA-based therapeutic, a muscarinic beta 2 agonist, a peptide or protein therapeutic, a monoclonal antibody, an antibody-drug conjugate, a radio pharmaceutical, other active pharmaceutical ingredients, pharmaceutically acceptable salts thereof, or any combination thereof.

[0134] Exemplary beta-mimetics comprise albuterol, arformoterol, bambuterol, bitolterol, broxaterol, carbuterol, clenbuterol, fenoterol, formoterol, glycopyrrolate, hexoprenaline, ibuterol, isoetharine, isoprenaline, levalbuterol, levosalbutamol, mabuterol, meluadrine, metaproterenol, olodaterol, orciprenaline, pirbuterol, procaterol, reproterol, rimiterol, ritodrine, salbutamol, salmefamol, salmeterol, soterenol, sulphonterol, terbutaline, tiaramide, tolubuterol, zinterol, vilanterol, pharmaceutically acceptable salts thereof, or any combination thereof.

[0135] Exemplary anticholinergics comprise tiotropium, oxitropium, flutropium, ipratropium, glycopyrronium, trospium, tolterodine, pharmaceutically acceptable salts thereof, or any combination thereof.

[0136] Exemplary vasodilators / bronchodilators comprise prostacyclin, epoprostenol, iloprost, treprostinil, umeclidinium, pharmaceutically acceptable salts thereof, or any combination thereof.

[0137] Exemplary corticosteroids comprise beclomethasone, betamethasone, budesonide, butixocort, ciclesonide, deflazacort, dexamethasone, etiprednol, flunisolide, fluticasone, loteprednol, mometasone, prednisolone, prednisone, rofleponide, triamcinolone, pharmaceutically acceptable salts thereof, or any combination thereof.

[0138] Exemplary PDE inhibitors include PDE3, PDE4, and PDE5 inhibitors comprising enprofyllin, theophyllin, roflumilast, lenamilast, cilomilast, tofimilast, pumafentrin, lirimilast, arofyllin, atizoram, sildenafil, tadalafil, vardenafd, avanafil, apremilast, ibudilast, cilostazol, milrinone, methylxanthine, pharmaceutically acceptable salts thereof, or any combination thereof.

[0139] Exemplary leukotriene antagonists include 5-LO inhibitors, and comprise montelukast, pranlukast, zafirlukast, pharmaceutically acceptable salts thereof, or any combination thereof.

[0140] Exemplary EGFR-inhibitors comprise cetuximab, trastuzumab, pharmaceutically acceptable salts thereof, or any combination thereof.

[0141] Exemplary Hl, H2, and H3 antihistamines comprise epinastine, cetirizine, azelastine, fexofenadine, levocabastine, loratadine, mizolastine, ketotifen, emedastine, dimetindene, clemastine, bamipine, cexchlorpheniramine, pheniramine, doxylamine, chlorophenoxamine, dimenhydrinate, diphenhydramine, promethazine, ebastine, desloratadine, meclizine, pharmaceutically acceptable salts thereof, or any combination thereof.

[0142] Exemplary antifibrotics comprise pirfenidone, nintedanib, pharmaceutically acceptable salts thereof, or a combination thereof.

[0143] Exemplary GPL-1 agonists comprise dulaglutide, exenatide, liraglutide, lixisenatide, semaglutide, tirzepatide, pharmaceutically acceptable salts thereof, or any combination thereof.

[0144] Exemplary non-prostanoid prostacyclin receptor agonists comprise selexipag

[0145] Exemplary antifungals comprise clotrimazole, miconazole, fluconazole, itraconazole, posaconazole, voriconazole, isavuconazole, amphotericin B, nystatin, terbinafine, anidulafungin, caspofungin, micafungin, flucytosine, griseofulvin, pharmaceutically acceptable salts thereof, or any combination thereof.

[0146] Exemplary antibiotics comprise vancomycin, teicoplanin, linezolid, daptomycin, trimethoprim / sulfamethoxazole, doxycycline, ceftobiprole, ceftaroline, clindamycin, dalbavancin, delafloxacin, fusidic acid, mupirocin, omadacycline, oritavancin, tedizolid, telavancin, tigecycline, ceftazidime, cefepime, ceftobiprole, ceftolozane / tazobactam, ceftazidime / avibactam, cefiderocol, piperacillin, ticarcillin / clavulanic acid, meropenem, imipenem, cilastatin, doripenem, meropenem, vaborbactam, levofloxacin, ciprofloxacin, imipenem, relebactam, aztreonam, tobramycin, amikacin, linezolid, tedizolid, tigecycline, omadacycline, eravacycline, daptomycin, oritavancin, penicillin, ampicillin, ampicillin-sulbactam, amoxicillin, amoxicillin-clavulnate,piperacillin-tazobactam, doxycycline, minocycline, moxifloxacin, pharmaceutically acceptable salts thereof, or any combination thereof.

[0147] Exemplary antivirals comprise acyclovir, valacyclovir, oseltamivir, zanamivir, remdesivir, famciclovir, ganciclovir, lamivudine, tenofovir, ribavirin, peramivir, baloxavir, abacavir, emtricitabine, lamivudine; tenofovir disoproxil fumarate, zidovudine, efavirenz, etravirine, nevirapine, rilpivirine, enfuvirtide, atazanavir, darunavir, fosamprenavir, ritonavir, saquinavir, tipranavir, maraviroc, dolutegavir, raltegravir, elvitegravir, bictegravir, ibalizumab, cobicistat, pharmaceutically acceptable salts thereof, or any combination thereof.

[0148] Exemplary other active pharmaceutical ingredients comprise alprazolam, alvesco, amikacin, ampion, arbekacin, azacytidine, aztreonam, betahistine, bronchitol, cannabidiol, ciclosporin, cisplatin, clofazimine, cromolyn sodium, desflurane, dexmedetomidine, diamorphine, diazepam, dihydroergotamine, doxepin, dronabinol, ensifentrine, epinephrine, epoprostenol, etripamil, fentanyl, idrevloride, iloprost, imatinib, inavir, inbrija, infasurfaero, isoamyl nitrite, itraconazole, kloxxado, methoxyflurane, metoclopramide, midazolam, monosodium alpha luminol, murepavadin, nalmefene, naloxone, nascobal, neumifd, nezulcitinib, niclosamide, nicotine, olanzapine, olitigaltin, olopatadine, opelconazole, oxymetazoline / tetracaine, oxytocin, pentetate calcium trisodium, pirfenidone, protollin, pulmazole, quinsair, remdesivir, ribavirin, seralutinib, sevoflurane, sodium pyruvate, spravato, sprix, staccato loxapine, sumatriptan, tacrolimus, teicoplanin, tizanidine, tobramycin, tobramycin+fosfomycin, trudhesa, vardenafil, varenicline, voriconazole, voriconazole, zolmitriptan, afrezza (insulin), alteplase, aralast, aviptadil, calfactant, carbetocin, cofirasersen, colifin, desmopressin, dornase alfa, foralumab, glucagon, merotocin, molgramostim, nasitrol, polyinosinic polycytidylic acid, recombinant tissueplasminogen activator, regdanvimab, sargramostim, simpinicline, sinapultide, sodium cromoglycate teriparatide, pharmaceutically acceptable salts thereof, or any combination thereof.

[0149] Exemplary pharmaceutically acceptable salts include chloride, bromide, iodide, sulphate, phosphate, methanesulphonate, nitrate, maleate, acetate, citrate, fumarate, tartrate, oxalate, succinate, benzoate, or p-toluenesulphonate.

[0150] While various embodiments have been described above, it should be understood that they have been presented by way of illustration and example only, and not limitation. It will beapparent to persons skilled in the relevant art that various changes in form and detail can be made therein without departing from the spirit and scope of this disclosure. Thus, the breadth and scope of this disclosure should not be limited by any of the above-described exemplary embodiments, but should be defined only in accordance with the appended claims and their equivalents. It will also be understood that each feature of each embodiment discussed herein, and of each reference cited herein, can be used in combination with the features of any other embodiment. All patents and publications discussed herein are incorporated by reference herein in their entirety.

Claims

CLAIMSWhat is claimed is:

1. An inhal er compri si ng :an atomization subassembly comprising an aerosolizing nozzle;a compression subassembly configured to convey a predetermined dosage amount of a liquid medicament to the atomization subassembly, the compression subassembly comprising:a stop ring,a capillary holder,a spring, anda driving tube having a continuous groove formed on an outer surface thereof; and an upper casing and a lower casing, the upper casing being rotatably connected to the lower casing and together being configured to collectively house the atomization subassembly and the compression subassembly therein, wherein each of the upper casing and the lower casing have a generally elliptical external form, andwherein an interior surface of the upper casing includes a first snap feature and a second snap feature, each of the first snap feature and the second snap feature being configured to be received within the continuous groove of the driving tube, wherein the driving tube has a substantially circular cross-section and the upper casing has a substantially elliptical cross-section, andwherein an inner surface of each of the first snap feature and the second snap feature is configured to deform upon assembly so as to correspond to a curvature of the outer surface of the driving tube within the continuous groove.

2. The inhaler of claim 1, wherein the first snap feature is diametrically opposed to the second snap feature.

3. The inhaler of claim 2, wherein the first snap feature and the second snap feature are aligned along a minor axis of the elliptical cross-section.

4. The inhaler of claim 3, wherein the interior surface of the upper casing also includes a first crush rib and a second crush rib, each of the first crush rib and the second crush rib being configured to abut against the outer surface of the driving tube, wherein the first crush rib is diametrically opposed to the second crush rib and the first crush rib and the second crush rib are aligned along a major axis of the elliptical cross-section.

5. The inhaler of claim 1, wherein a spindle is coupled to the driving tube so as to allow rotation of the spindle relative to the driving tube and a rider is coupled to the spindle, the rider being rotationally constrained such that the rider moves axially when the spindle rotates relatives to the driving tube, wherein a position of the rider is configured to be a dosage counter, and wherein the spindle and the driving tube include mating surfaces that are configured to abut against each other to form a detent.

6. The inhaler of claim 5, wherein the mating surfaces are angled and configured to provide resistance to rotation of the spindle relative to the driving tube by hand alone.

7. The inhaler of claim 1, wherein the upper casing and the lower casing are configured to collectively house a cartridge therein, the cartridge comprising a liquid medicament.

8. The inhaler of claim 7, wherein the liquid medicament comprises a beta-mimetic, an anticholinergic, a vasodilator / bronchodilator, a corticosteroid, a PDE inhibitor, a leukotriene antagonist, an EGFR-inhibitor, an Hl, H2, and / or H3 -antihistamine, a PAF antagonist, a PI3 kinase inhibitor, GPL-1 agonists, a non-prostanoid prostacyclin receptor agonist, an antifibrotic, an antifungal, an antibiotic, an antiviral, an anti-tumor agent, an anti-inflammatory, mRNA, siRNA or DNA-based therapeutic, a muscarinic beta 2 agonist, a peptide or protein therapeutic, a monoclonal antibody, an antibody-drug conjugate, a radio pharmaceutical, other active pharmaceutical ingredients, pharmaceutically acceptable salts thereof, or any combination thereof.

9. The inhaler of any of claims 1-8, wherein the stop ring is annular in shape and has an inner diameter defining an opening therethrough, andthe capillary holder has an outer diameter that is less than the inner diameter of the stop ring such that the capillary holder can pass through the opening of the stop ring when the stop ring and the capillary holder are concentrically aligned, andwherein the stop ring is displaceable between a first position in which the stop ring and the capillary holder are concentrically aligned and a second position in which the stop ring is laterally shifted to partially overlap the capillary holder, the stop ring being configured to block axial upwards movement of the capillary holder when in the second position to maintain the spring in a compressed state, andwherein when the stop ring is in the second position, each of a top surface of the capillary holder and a bottom surface of the stop ring includes an overlapping portion and a non-overlapping portion, the respective overlapping portions being radially aligned with each other and the respective non-overlapping portions being radially offset from each other, andwherein the bottom surface of the stop ring includes at least one upwardly-extending step disposed between a contact section of the overlapping portion thereof and a non-contact section of the overlapping portion thereof, the upwardly-extending step being configured to longitudinally offset the non-contact section of the overlapping portion of the stop ring from the top surface of the capillary holder to prevent contact therebetween.

10. The inhaler of claim 9, wherein the contact section of the overlapping portion of the stop ring contacts the top surface of the capillary holder when the stop ring is in the second position.

11. The inhaler of claim 9, wherein the overlapping portion of the capillary holder includes a contact section and a non-contact section, the contact section of the capillary holder being in contact with the contact section of the stop ring when the stop ring is in the second position and the non-contact section of the capillary holder being longitudinally spaced apart from the noncontact section of the stop ring when the stop ring is in the second position.

12. The inhaler of claim 9, wherein the bottom surface of the stop ring includes two opposing upwardly-extending steps, each upwardly-extending step disposed between the contact section of the overlapping portion thereof and the non-contact section of the overlapping portion thereof, each upwardly-extending step being configured to longitudinally space apart the non-contactsection of the overlapping portion of the stop ring from the top surface of the capillary holder to create a gap which prevents contact therebetween.

13. The inhaler of claim 9, wherein the overlapping portion and the non-overlapping portion of the top surface of the capillary holder collectively extend around an entire circumference of the capillary holder, and wherein the overlapping portion and the non-overlapping portion of the bottom surface of the stop ring collectively extend around an entire circumference of the stop ring.

14. The inhaler of claim 9, wherein the upwardly-extending step extends at an oblique angle with respect to the contact section of the overlapping portion of the stop ring.

15. The inhaler of claim 9, wherein the upwardly-extending step is configured to prevent a load being applied between the non-contact sections of the overlapping portions of the stop ring and the capillary holder, respectively.

16. The inhaler of claim 9, wherein a trigger is connected to the stop ring and the trigger laterally protrudes from an opening of a casing of the inhaler when the stop ring is in the second position.

17. The inhaler of claim 9, wherein the stop ring includes a protrusion extending from the contact section thereof, the protrusion extending in a radially outward direction.

18. The inhaler of claim 17, wherein the contact section of the overlapping portion of the stop ring contacts the top surface of the capillary holder when the stop ring is in the second position and the protrusion is configured to maximize an area of the contact section, the protrusion having a first radial width and the capillary holder having a second radial width, the first radial width being between 75% and 125% greater than the second radial width.

19. The inhaler of any of claims 1-8, wherein the stop ring is annular in shape and has an inner diameter defining an opening therethrough, andthe capillary holder has an outer diameter that is less than the inner diameter of the stop ring such that the capillary holder can pass through the opening of the stop ring when the stop ring and the capillary holder are concentrically aligned, andwherein the upper casing defines a compartment between a first interior surface and a second interior surface, the stop ring and at least a portion of the capillary holder being disposed within the compartment, andwherein the stop ring is displaceable between a first position in which the stop ring and the capillary holder are concentrically aligned and a second position in which the stop ring is laterally shifted in a first direction to partially overlap the capillary holder, the stop ring being configured to block axial upwards movement of the capillary holder when in the second position to maintain the spring in a compressed state, andwherein the first interior surface of the upper casing includes a helical ramp configured to interact with the capillary holder and the second interior surface of the upper casing includes at least one ramp configured to interact with the stop ring, the at least one ramp being configured to provide resistance during movement of the stop ring in a second direction, the second direction opposing the first direction.

20. The inhaler of claim 19, wherein the at least one ramp extends at an oblique angle with respect to a longitudinal axis of the inhaler.

21. The inhaler of claim 19, wherein the at least one ramp is configured to urge the stop ring in an axially downward direction towards the lower casing when the stop ring moves in the second direction.

22. The inhaler of claim 19, wherein the second interior surface of the upper casing includes two ramps configured to interact with the stop ring, each ramp being configured to provide resistance during movement of the stop ring in a second direction, the second direction opposing the first direction.

23. The inhaler of claim 22, wherein the two ramps include a first ramp and a second ramp, the first ramp being disposed between 60 and 120 degrees away from the second ramp.

24. The inhaler of claim 23, wherein the first ramp is disposed between 80 and 100 degrees away from the second ramp.

25. The inhaler of claim 19, wherein a trigger is connected to the stop ring and the trigger laterally protrudes from an opening of the upper casing when the stop ring is in the second position.

26. The inhaler of claim 19, wherein when the stop ring is in the second position, each of a top surface of the capillary holder and a bottom surface of the stop ring includes an overlapping portion and a non-overlapping portion, the respective overlapping portions being radially aligned with each other and the respective non-overlapping portions being radially offset from each other, and wherein the bottom surface of the stop ring includes at least one upwardly -extending step disposed between a contact section of the overlapping portion thereof and a non-contact section of the overlapping portion thereof, the upwardly-extending step being configured to longitudinally offset the non-contact section of the overlapping portion of the stop ring from the top surface of the capillary holder to create a gap which prevents contact therebetween.

27. The inhaler of claim 26, wherein the contact section of the overlapping portion of the stop ring contacts the top surface of the capillary holder when the stop ring is in the second position.

28. The inhaler of claim 26, wherein the overlapping portion of the capillary holder includes a contact section and a non-contact section, the contact section of the capillary holder being in contact with the contact section of the stop ring when the stop ring is in the second position and the non-contact section of the capillary holder being longitudinally spaced apart from the noncontact section of the stop ring when the stop ring is in the second position.

29. The inhaler of claim 26, wherein the bottom surface of the stop ring includes two opposing upwardly-extending steps, each upwardly-extending step is disposed between the contact section of the overlapping portion thereof and the non-contact section of the overlapping portion thereof, each upwardly-extending step being configured to longitudinally space apart the non-contactsection of the overlapping portion of the stop ring from the top surface of the capillary holder to create a gap which prevents contact therebetween.

30. The inhaler of claim 26, wherein the overlapping portion and the non-overlapping portion of the top surface of the capillary holder collectively extend around an entire circumference of the capillary holder, and wherein the overlapping portion and the non-overlapping portion of the bottom surface of the stop ring collectively extend around an entire circumference of the stop ring.

31. The inhaler of claim 26, wherein the upwardly-extending step extends at an oblique angle with respect to the contact section of the overlapping portion of the stop ring.

32. The inhaler of claim 26, wherein the upwardly-extending step is configured to prevent a load being applied between the non-contact sections of the overlapping portions of the stop ring and the capillary holder, respectively.

33. The inhaler of claim 26, wherein the stop ring includes a protrusion extending from the contact section thereof, the protrusion extending in a radially outward direction.

34. The inhaler of claim 33, wherein the contact section of the overlapping portion of the stop ring contacts the top surface of the capillary holder when the stop ring is in the second position and the protrusion is configured to maximize an area of the contact section, the protrusion having a first radial width and the capillary holder having a second radial width, the first radial width being between 75% and 125% greater than the second radial width.

35. An inhaler of any of claims 1-8, wherein the atomization subassembly comprises:a central tube defining an axial lumen therethrough and having a plurality of ribs around a circumference thereof, each rib of the plurality of ribs having a retention pad formed thereon, wherein the capillary holder of the compression subassembly comprises a capillary tube slidingly disposed within the axial lumen of the central tube, andwherein each retention pad has an inclined outer surface that is configured to contact an inner surface of the upper casing, the inclined outer surface flaring radially outward from a top end to a bottom end, wherein the bottom end of the inclined outer surface has an edge.

36. The inhaler of claim 35, wherein the plurality of ribs includes four ribs.

37. The inhaler of claim 36, wherein the four ribs are equally spaced around a circumference of the central tube.

38. The inhaler of claim 35, wherein each retention pad has a variable thickness that increases from the top end to the bottom end thereof.

39. The inhaler of claim 35, wherein the edge at the bottom end of the inclined outer surface extends substantially perpendicular to a longitudinal axis of the inhaler.

40. The inhaler of claim 35, wherein each retention pad is integrally formed on the central tube.

41. The inhaler of claim 35, wherein the central tube is formed from a first polymer material and the upper casing is formed from a second polymer material, the first polymer material being harder than the second polymer material.

42. The inhaler of claim 41, wherein the first polymer material is polyether ether ketone (PEEK) and the second polymer material is acrylonitrile butadiene styrene (ABS).

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