Multi-unit dose dry powder inhaler and method of use

Abstract

A multi-unit dose dry powder inhaler device (50) comprising a housing body having a swivel chamber therein, at least one air inlet (60), a mouthpiece (56), a rotatable downfall wheel (82) having at least two capsule spaces each configured to hold a capsule, and a drive mechanism (70, 74) configured to repeatedly align the downfall wheel (82) in predetermined angular increments such that each time the downfall wheel is aligned, one of the capsule spaces moves adjacent to the swivel chamber, and a pair of side inclined portions (114, 115) adjacent to the swivel chamber and the downfall wheel. The side inclined portions (114, 115) may be configured to cooperate with a central inclined portion (130) located within the capsule space to drive the capsule radially outward from the capsule space into the swivel chamber, thereby enabling the device to automatically load multiple capsules into the swivel chamber sequentially at one time. A method of use is also provided.

Description

Technical Field

[0001] Cross - Reference to Related Applications This application claims the benefit of priority of U.S. Provisional Application No. 63 / 365,229, filed May 24, 2022, which is hereby incorporated by reference in its entirety.

[0002] Incorporation by Reference All publications and patent applications mentioned in this specification are hereby incorporated by reference in their entirety for all purposes as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference to the same extent.

[0003] Embodiments of the present disclosure generally relate to inhalation devices. Specifically, some implementations of the present disclosure relate to dry powder inhalation devices having multi - unit dose capabilities.

Background Art

[0004] The present disclosure relates to inhalation devices, such as for inhaling dry powder medications for treating asthma. Inhalation devices for inhaling the contents of medical capsules are already known. However, available inhalers are not entirely satisfactory from an operational perspective and there is room for improvement.

[0005] U.S. Patent No. 7,284,552 to Mauro Citterio, titled "Inhalation Device" and issued on October 23, 2007, provides an example of a prior - art inhalation device similar to those provided herein. The inhalation device includes an inhaler body defining a recess for a drug capsule that holds the substance to be inhaled, and a nose piece / mouth piece in communication with the capsule recess. The device also includes at least one perforating element that is coupled to the inhaler body and provided for perforating the capsule to allow an external air stream to mix with the capsule contents and be inhaled through the nose piece / mouth piece.

[0006] U.S. Patent No. 8,479,730, titled "Inhalation Device" and issued to Dominik Ziegler et al. on July 9, 2013, provides other examples of prior art inhalation devices. The inhalation device of the '730 patent is similar in structure and operation to that of the '552 patent, but has a mouthpiece rotatably attached to the edge of the inhaler body.

[0007] The above inhaler is a single-dose device that requires the user to perform many steps to administer each dose. What is not provided by prior art inhalers is a device that requires fewer steps and is easier to use.

Brief Description of the Drawings

[0008] A better understanding of the features and advantages of the present disclosure can be obtained by reference to the following detailed description that sets forth exemplary embodiments in which the principles of the present disclosure are utilized, and to the accompanying drawings.

[0009]

Figure 1

[0010]

Figure 2

[0011]

Figure 3

[0012]

Figure 4

[0013]

Figure 5

[0014]

Figure 6

[0015]

Figure 7

[0016]

Figure 8

[0017]

Figure 9

[0018]

Figure 10

[0019]

Figure 11

[0020]

Figure 12

[0021]

Figure 13

[0022]

Figure 14

[0023]

Figure 15

[0024]

Figure 16

[0025]

Figure 17

[0026]

Figure 18

[0027]

Figure 19

[0028]

Figure 20

[0029]

Figure 21

[0030]

Figure 22

[0031]

Figure 23

[0032]

Figure 24

[0033]

Figure 25

[0034]

Figure 26

[0035]

Figure 27A - O

[0036]

Figure 27P

[0037]

Figure 28A - 46

[0038] With reference to the reference numerals of the foregoing figures, an exemplary single-dose inhaler device 1 will be described below. As best seen in FIG. 1, the exemplary inhaler device 1 includes an inhaler mouthpiece 3 that includes a flange 4 having a peg 5 that can engage a corresponding hole 6 formed in the inhaler body 2. Although the term "mouthpiece" is used herein, it should be understood that in some embodiments, this feature may be used as a mouthpiece and / or a nose piece.

[0039] The hole 6 is provided with a longitudinal slot (not shown) that can engage the intersecting teeth 8 of the peg 5 and a lower end ring-shaped recess (not specifically shown) through which the teeth 8 can slide.

[0040] Accordingly, the peg 5 can be engaged with the hole by passing the teeth 8 through the slot 7, and when it reaches the lower end, the peg 5 can be rotated completely within the hole 6, thereby also rotating the inhaler mouthpiece 3 relative to the inhaler body 2.

[0041] The inhaler mouthpiece 3 can be locked in its closed state shown in FIGS. 3-6 by a snap-type locking means that includes a hook portion 18 of the flange 4 having a small raised portion (not shown) for engaging a corresponding raised portion 20 formed inside a locking recess 19 defined within the inhaler body 2.

[0042] The inhaler body 2 is further provided with a recess for the capsule, the recess being open upwards and communicating with the outside via a perforated plate or grid 11 which is designed in the flange 4 to be included in the inhaler mouthpiece 3 and to separate the capsule recess 9 from the duct 12 of the mouthpiece.

[0043] The capsule 13 can engage in the recess 9, the capsule being of a type known per se and being perforated so as to allow easy access to the drug contents held therein, the perforation operation being carried out by any suitable perforating means.

[0044] In the disclosed embodiment, the perforating means comprises a pair of perforating needles 14 which can be slid laterally so as to be biased in the opposite direction by an elastic element which in this embodiment comprises a coil spring 15, each coil spring surrounding the perforating needle 14 coaxially and operating between respective abutment elements 16 of rigidity and a hollow push-button element 17 together with the inhaler body 2. The perforating needles 14 may be similar to hollow hypodermic needles and may have a one-sided inclined tip in order to smoothly advance the perforating needles 14 when perforating the coating of the capsule 13. In other embodiments, the perforating needles 14 may be solid or may have other tip configurations.

[0045] The operation of the inhalation device according to the present disclosure is as follows. In the open state, as shown in FIG. 2, the capsule is engaged with the capsule recess 9, and the mouthpiece 3 is snap-closed to the inhaler body 2. By pressing the push-button element 17, the piercing needle 14 pierces the capsule 13, whereby its contents, usually fine powder, are communicated with the capsule recess. By applying a suction force to the mouthpiece 3, an air flow is generated that enters the capsule recess from the outside through the inlet 10, whereby the air flow mixes with the capsule contents. The tangential orientation of the inlet 10 with respect to the capsule recess 9 causes the incoming air to produce a swirling air flow. This swirling air flow lifts the capsule 13 upward (as indicated by arrow A in FIG. 7) from the capsule pocket 30 to the larger upper part of the capsule recess 9. The swirling air flow further rotates the capsule 13 within the recess 9 generally around the transverse axis of the capsule and generally around the longitudinal axis of the recess 9 (i.e., generally the vertical axis of FIG. 7), as indicated by arrow B. However, since the diameter of the recess 9 is larger than the length of the capsule 13, the capsule can move around the recess 9 rather than rotate around a single fixed axis when it rotates. The centrifugal force from the rotating capsule 13 helps its contents exit from the pierced end of the capsule, where the contents are aerosolized by the swirling air flow, pass through the mouthpiece grid 11 and the duct 12, and are inhaled by the user. In some embodiments, dry powder deaggregation is achieved by: 1) shear through the pierced hole in the capsule; 2) turbulence from the swirling air flow within the capsule chamber; 3) particle collisions (with the walls of the device, with the mouthpiece grid, and with other particles).

[0046] The inhalation device 1 has a very simple structure. A further advantage of the inhalation device 1 is the specially designed configuration of the piercing needle that can be assimilated to a hypodermic needle, as described above. This type of needle has a very small resistance to piercing and provides a very precise operation, so that a needle with a relatively large diameter can be used without damaging the capsule, thereby enabling a very simple piercing operation. The use of only a few piercing needles, only two in some embodiments, makes it possible to reduce the contact surface between the needle and the capsule (the piercing cross-section being the same), resulting in a reduction in friction and a reduction in the problems affecting conventional inhalers.

[0047] Referring to FIGS. 8-14, another exemplary inhalation device 50 constructed in accordance with aspects of the present disclosure is shown. The device 50 is a multi-unit dose dry powder inhaler. This device includes a capsule recess or swivel chamber having a structure and operation similar to the structure and operation of the aforementioned inhalation device 1. However, instead of requiring the user to manually insert one drug capsule at a time, the device 50 is provided to the user pre-loaded with a plurality of capsules that are automatically sequentially loaded into the swivel chamber. In this exemplary embodiment, the device 50 may be provided with up to 30 pre-loaded capsules. Since the inhalation device 50 can be used with individual capsules of standard size rather than a drug packaged in a compartment of a blister strip, various formulations of the drug for the device can be provided using standard capsule filling equipment without the need for special blister pack filling equipment. Another advantage of the capsules over blisters is that they can accommodate a larger amount of powder, thereby enabling a higher dose delivery per inhalation.

[0048] In this exemplary embodiment, the inhalation device 50 generally has a pear shape or a teardrop shape and has a body formed by a front cover 52 and a rear cover 54. The covers 52 and 54 may be assembled by fasteners, plastic snap features, adhesives, ultrasonic welding, and / or other suitable assembly methods. The mouthpiece 56 may be provided above the capsule chamber portion 58. The mouthpiece 56 may be hingedly attached to the capsule chamber portion 58 so as to rotate about a horizontal rotation axis between a closed position (as shown) and an open position (see FIG. 15-3) where an empty drug capsule can be removed from the capsule chamber portion 58 (see FIG. 15-4). As described above, a recess 106 (see FIG. 18) similar to the recess 9 shown in FIG. 4 may be formed in the capsule chamber portion 58. In some embodiments, the main portion of the swivel chamber / capsule recess 106 has a height of less than 0.26 inches or is less than 12% higher than the diameter of the capsule received by the main portion. This recess is shallower than prior art devices and is thought to reduce powder deposition and improve delivery efficiency. Air channels (see FIG. 18) may be provided on both sides of the recess in fluid communication with the vent 60 to provide intake air for swirling the drug capsule within the recess. In some embodiments, the swivel chamber / capsule recess 106 is not configured to allow the capsule to rotate and only directs one or more air flows over, around, and / or through the capsule.

[0049] The pivoting mouse-piece cover 62 may be provided over the mouse-piece 56. In this exemplary embodiment, the mouse-piece cover 62 includes a pair of downwardly depending arms that extend over the mouse-piece 56 and over the upper ends of the front cover 52 and the rear cover 54. The mouse-piece cover 62 pivots about a horizontal axis extending between its two arms and moves through an arc of approximately 90 degrees between a closed position (as shown) and an open position (see Fig. 15-1) where the mouse-piece 56 is exposed. In other embodiments, this angular range of motion may be greater or less depending on the function of the internal mechanism that is driven by opening and closing the mouse-piece cover. As best seen in Figs. 8 and 12, recesses 64 may be provided in the front cover 52 and the rear cover 54 to provide a stop for at least partially receiving the mouse-piece cover 62 when the cover 62 is open. In this exemplary embodiment, the device 50 is 30 mm thick over the entire front and rear covers and has a maximum thickness of less than 35 mm over the entire length of the downwardly depending arms of the mouse-piece cover 62. In this exemplary embodiment, the device 50 has a height of less than 120 mm and a width of less than 65 mm at its widest point.

[0050] As shown in Figs. 8 and 9, a dose count opening 66 may be provided in the front cover 52 to indicate to the user how much dose remains before the device 50 is depleted.

[0051] Referring to FIGS. 15-1 to 15-6, a series of steps showing the overall operation of the inhalation device 50 are schematically shown. In this exemplary embodiment, the user first rotates the mouthpiece cover 62 from the closed position to the open position, where the mouthpiece cover clicks into place. This operation exposes the mouthpiece 56, punctures one of the pre-loaded drug capsules in the device 50, and aligns the drug capsule into the swivel chamber. Also, this operation advances the dose count wheel so that the dose count shown through the dose count opening is decremented by 1.

[0052] After the mouthpiece cover 62 has been rotated to the open position, the user places the mouthpiece 56 in the mouth and inhales the dry powder released from the swivel capsule as shown in FIG. 15-2 and described above. Thereafter, the user flips open the mouthpiece 56 as shown in FIG. 15-3, inverts the device 50 to discard the empty drug capsule from the swivel chamber as shown in FIG. 15-4, and closes the mouthpiece 56 as shown in FIG. 15-5. Finally, the user closes the mouthpiece cover 62 as shown in FIGS. 15-6, and prepares the device 50 to repeat the above procedure when the next dose is to be inhaled. In some embodiments, the mouthpiece cover 62 cannot (or will not remain) move to the closed position unless the mouthpiece 56 is first opened and closed, as will be described in more detail later.

[0053] Referring to FIG. 16, the exploded perspective view shows the components of an exemplary inhalation device 50 (fasteners are omitted for clarity). The device 50 includes a front cover 52 (shown from left to right), a slide dose count window 68, a dose count wheel 70, a front chassis cover 72, a carousel 74, a chassis 76 with a capsule chamber portion 58, a mouthpiece 56, a mouthpiece cover 62, a hub spring 78, a piercing hub 80, a downfall wheel 82, a locking arm 84, a rear cover 54, a mouthpiece cover spring 86, and a drive plate 88.

[0054] When the device 50 is assembled, the carousel 74 is rotatably received within a lower cavity 90 that faces the front of the chassis 76. The carousel 74 is captured within the lower cavity 90 by a front chassis cover 72 that can be fixed to the chassis 76 by four fasteners (not shown) or any means suitable for alignment and attachment. The central hub of the carousel 74 extends forwardly through a central opening in the front chassis cover 72 so as to be able to engage the dose count wheel 70. The dose count wheel 70 may be attached to the carousel 74 by a single fastener through its center or any means suitable for alignment and attachment so as to be able to rotate with the carousel 74. A pair of forwardly projecting pegs or other alignment features may be provided on the central hub of the carousel 74 to engage a mating recess on the back side of the dose count wheel 70 so as to keep the dose count wheel properly aligned with the carousel 74. The slide dose count window 68 is received within a mating slot on the inner / back surface of the front cover 52 that sandwiches the slide window 68 between the cover 52 and the wheel 70. This configuration allows the slide window 68 to slide vertically, as will be described in more detail later. The front cover 52 may be fixed to the front of the chassis 76 by a single fastener (not shown) and / or any other means suitable for alignment and attachment.

[0055] The downfall wheels 82 are configured to be rotatably received in a rearward-facing upper cavity 92 of the chassis 76. The downfall wheels are captured in the upper cavity 92 by the rear cover 54, which may be secured to the underside of the chassis 76 by three fasteners (not shown) and / or any other means suitable for alignment and attachment.

[0056] The puncture hub 80 may be provided with two puncture pins or sharps 94 configured to puncture the same side of the medicament capsule with opposite hemispherical ends of the capsule (perpendicular to the longitudinal axis of the capsule) rather than piercing the end of the capsule along the longitudinal axis as is done by the device 1 described above. When the device 50 is assembled, the puncture hub 80 resides within the central bore of the downfall wheel 82. The hub 80 has a forward extending axle that is received in a mating bore 96 in the upper cavity 92 of the chassis 76 and a rearward extending axle that is received in a mating bore 98 in the inner surface of the rear cover 54. In this configuration, the puncture hub 80 is configured to pivot about a front-to-rear horizontal axis that allows the puncture pin to rotate between a lower position and an upper position, as will be described in more detail below. A torsion hub spring 78 may be provided between the hub 80 and the chassis 76 to bias the puncture pin 94 towards the lower position. In an alternative embodiment (not shown), a four-bar mechanism may be used instead of a rotating piercing hub to move the piercing pin 94 into the capsule.

[0057] The locking arm 84 may be configured to slide up and down within a vertical channel formed between the underside of the chassis 76 and the inside of the rear cover 54. The locking arm 84 serves to prevent the mouthpiece cover 62 from returning to or remaining in its upper position over the mouthpiece 56 until after the mouthpiece 56 has been opened and closed, as previously described. The configuration and operation of the locking arm 84 will be described in more detail below.

[0058] The drive plate 88 may be configured to be present within the fitting recess 100 of the rear arm of the mouthpiece cover 62 such that the drive plate 88 rotates together with the cover 62. The drive plate 88 includes a bent arm 102 extending in the circumferential direction and teeth 85 extending through the arcuate slot of the rear cover 54 to enable the mouthpiece cover 62 to rotationally drive the downfall wheel 82 by 90 degrees at a time, as will be described in detail below. A mouthpiece cover spring 86 may be provided between the drive plate 88 and the rear cover 54 to bias the mouthpiece cover 62 towards its lower / open state. In some embodiments, the functional portion of the drive plate 88 may be provided directly within the mouthpiece cover 62, and the drive plate itself may be omitted.

[0059] The mouthpiece 56 may be provided with a hinge functional portion along its rear edge (not shown) for fitting with the hinge functional portion 104 on the upper rear edge of the chassis 76. This configuration enables the mouthpiece 56 to rotate about a vertical horizontal axis between a closed position and an open position.

[0060] The rear cover 54 may be provided with an upper inclined portion 115 facing inward as shown. The function of the inclined portion 115 will be described below in the description of FIGS. 24 and 25.

[0061] Referring to FIG. 17, the overall capsule alignment sequence of the inhalation device 50 will be described. In this exemplary embodiment, the device 50 is configured such that 30 medicament capsules are pre-loaded. In FIG. 17, the capsules are numbered from 1 to 30, with number 1 being the first dose and number 30 being the last dose. Capsules 1 and 2 are loaded into two of four spaces that are 90 degrees apart across the outer circumference of the downfall wheel 82. Capsules 3 to 17 are loaded into 15 spaces that are 22.5 degrees apart and form an outer ring across the outer circumference of the carousel 74. Capsules 18 to 30 are similarly loaded into 13 spaces that are 22.5 degrees apart and form an inner ring within the carousel 74. Alternatively, capsules 1 to 15 are loaded into 15 outer ring spaces and capsules 16 to 30 are loaded into 15 inner ring spaces. In some embodiments, all of the capsules can be loaded from the same side of the device (from the front of the carousel in this exemplary embodiment). Thereafter, the alignment mechanism is actuated twice to align capsules 1 and 2 from the outer ring of the carousel to downfall wheel positions 1 and 2 and prepare the device for use at any time. This leaves two empty spaces in the inner ring, as shown in the figure. In other embodiments, the downfall wheel may have fewer than four or more than four capsule spaces. In some embodiments, the carousel can be omitted and means can be provided for the user to insert capsules from the side of the device into the downfall wheel to provide an automatic piercing solution for single-dose or multi-dose devices.

[0062] During operation, the downfall wheel 82 rotates counterclockwise (as viewed from the back of device 50), and the carousel 74 rotates clockwise. The downfall wheel 82 is aligned 90 degrees at a time, and the carousel 74 is aligned 22.5 degrees. A drive plate 88 (FIG. 16) coupled to the inside of the mouthpiece cover 62 (FIG. 16) drives the downfall wheel 82 (FIG. 17) each time the cover 62 is moved 90 degrees from the closed position to the open position, as will be described in more detail later. Similarly, as will be described in more detail later, each time the downfall wheel 82 is aligned 90 degrees, it drives the carousel 22.5 degrees via a Geneva-type mechanism (not shown). With this configuration, when the mouthpiece cover 62 is opened, the capsule at position number 1 is punctured and moved into the swivel chamber 106, and each remaining capsule advances to a position previously occupied by the preceding capsule. In other words, capsule number 2 remains within its cavity but advances to the position previously occupied by capsule number 1, capsule number 3 advances from the carousel 74 to the position of the downfall wheel 82 previously occupied by capsule number 2 (but in a different cavity), and so on. This means that capsule number 30 ultimately advances through each position within the inner ring of the carousel 74, moves into the outer ring of the carousel 74, advances through each position within the outer ring, moves from the carousel 74 to position number 2 of the downfall wheel 82, and advances to position number 1 before being loaded into the swivel chamber 106.

[0063] Referring to FIGS. 18 to 20, the details of the chassis 76 are shown. As shown in FIGS. 18 and 19, a series of ratchet teeth 108 are provided along the inner surface of the central hub of the lower cavity 90 to prevent the carousel 74 (not shown) from rotating in the reverse direction. As best seen in FIG. 19, the lower cavity 90 may be provided with an inner inclined portion 110 configured to guide the rear end of the drug capsule upward from the inner ring to the outer ring of the chassis cavity 90 of the chassis 76 when they are advanced by the rotation of the carousel 74 (shown in FIG. 17). Further, the lower cavity 90 may be provided with an outer inclined portion 112 configured to guide the rear end of the drug capsule upward from the outer ring of the chassis cavity 90 of the chassis 76 into the upper cavity 92 of the chassis 76 and into the downfall wheel 82 (shown in FIG. 17) by the rotation of the carousel 74. As shown in FIG. 20, the upper cavity 92 may be provided with an upper inclined portion 114 configured to guide the front end of the drug capsule upward when they are advanced from the downfall wheel into the swivel chamber 106.

[0064] Referring to FIG. 21, the details of the front chassis cover 72 are shown. The cover 72 may be provided with an inner inclined portion 116 (corresponding to the inner inclined portion 110 shown in FIG. 19) configured to guide the front end of the drug capsule upward from the inner ring to the outer ring of the chassis cover 72 when they are advanced by the rotation of the carousel 74 (shown in FIG. 17). Further, the cover 72 may be provided with an outer inclined portion 118 (corresponding to the outer inclined portion 112 shown in FIG. 19) configured to guide the front end of the drug capsule upward from the outer ring of the chassis cover 72 into the upper cavity 92 of the chassis 76 and into the downfall wheel 82 (shown in FIG. 17) by the rotation of the carousel 74.

[0065] Referring to FIGS. 22 and 23, the details of the carousel 74 are shown. On the outer periphery of the central hub 120, triangular protrusions 122 may be provided between the capsule spaces. The central inclined portion 124 may be provided with a pushing surface or a driving surface configured to cooperate with the triangular protrusions 122 and the aforementioned lateral inclined portions as shown to move the capsules from the inner ring to the outer ring and from the outer ring to the upper cavity 92 / downfall wheel 82. In this embodiment, the central inclined portion 124 has a width that is about 40% of the length of the capsule, and each of the aforementioned lateral inclined portions has a width that is about 30% of the capsule. In some embodiments, the lateral inclined portions have a width that is at least 27%, 28%, 29%, 30%, 31%, 32% or 33% of the length of the capsule. In other embodiments (not shown), a fixed central inclined portion may be provided on the chassis, and by providing lateral inclined portions provided on the carousel and / or the downfall wheel, the positions of the inclined portions may be exchanged. As shown in FIG. 23, one or more flexure arms 126 may be provided inside the central hub 120. The flexure arm 126 may be configured to cooperate with the ratchet teeth 108 (shown in FIGS. 18 and 19) to prevent the carousel 74 from rotating in the reverse direction.

[0066] Referring to FIGS. 24 and 25, the details of the downfall wheel 82 are shown. As described above, the downfall wheel 82 may be provided with four capsule spaces 128, only two of which are occupied at any given time. Each capsule space 128 may be provided with a central inclined portion 130 for operating in cooperation with the upper inclined portions 114 and 115 described above to sequentially move each capsule from the upper cavity 92 of the chassis 76 / downfall wheel 82 to a swivel chamber (not shown). In this embodiment, a space is left between the central inclined portion 130 and the side inclined portion so that the puncture pin 94 can pass therebetween. In this exemplary embodiment, the puncture pin 94 has a diameter of about 0.047 inches. The upper inclined portions 114 and 115 (shown in FIGS. 20 and 16 respectively) are configured to engage the hemispherical ends of the capsules, while the central inclined portion 130 is configured to engage the central cylindrical portions of the capsules. Accordingly, the inclined portions 114 and 115 may be given a compound angle (i.e., angled with respect to a vertical plane traversing the rear cover and angled with respect to a horizontal plane). In some embodiments, the inclined portions 114 and 115 are angled at about 45 degrees with respect to both of these planes. In some embodiments, the inclined portions 114 and 115 have an angle between 30 degrees and 60 degrees with respect to both of these planes.

[0067] For the downfall wheel 82, a solid surface 131 may be provided between the capsule spaces for sealing the lower end of the swivel chamber for use when the capsule is loaded into the chamber so that any gap can be controlled such that air does not enter the chamber from the lower end or the air flow is at least reduced to achieve the desired resistance as a system. As best seen in FIG. 24, on the leading edge of the downfall wheel 82, four forward projecting drive nubs 132 are provided which are configured to engage in a Geneva mechanism-like manner with the external teeth (shown in FIG. 27A) of the dose count wheel 70 so as to drive the dose count wheel 70 and the attached carousel 74 over 22.5 degrees each time the downfall wheel is aligned 90 degrees. In this exemplary embodiment, the drive nub 132 also serves to drive the puncture hub 80, as will be described in detail later. As best seen in FIG. 25, on the trailing edge of the downfall wheel 82, four radially outwardly extending ratchet teeth 134 are provided which are configured to cooperate with the bent arms 102 (shown in FIG. 16) of the drive plate 88 so that the drive plate 88 can drive the downfall wheel 82, as described above.

[0068] Referring to FIG. 26, the details of the dose count wheel 70 are shown. The dose count wheel 70 may be provided with a series of numbers, each number representing the number of remaining capsules / doses. In this exemplary embodiment, numbers 1 (or 0) to 30 are provided. In other embodiments (not shown), more or fewer dose numbers may be represented. For example, 7, 14, 21, 28, 31, 35, 42, 45, 49, 56, 60, 61, 62, 63, or 70 doses may be represented (the device is configured with space for at least that many doses). In some embodiments, some of the capsule spaces in the downfall wheel and / or carousel remain unused and do not have a number associated with them (other than 0) on the dose count wheel 70. In some embodiments, the downfall wheel may have only two capsule spaces arranged at 180-degree intervals, with a capsule pre-loaded in only one of the spaces. In other embodiments, the downfall wheel may have three, five, or more capsule spaces arranged at equal intervals over its outer circumference. In this exemplary embodiment, the numbers from 30 to 0 are arranged in a spiral extending from the outer radius to the inner radius of the dose count wheel 70 and covering 675 degrees, as shown. In other embodiments (not shown), the spiral may extend from the inner radius to the outer radius or may extend at a larger or smaller angle.

[0069] As shown, a groove 136 extending spirally may be provided on the front side of the dose count wheel 70. A mating protrusion (not shown) may be provided on the back side of the slide dose count window 68 (shown in FIG. 16). In this configuration, as the slide window 68 rotates counterclockwise (as seen in FIG. 26) over 675 degrees, it is slowly driven vertically upward by the dose wheel 70. This allows only one number at a time to be visible through the opening 66 of the front cover 52 (shown in FIG. 16).

[0070] Referring to FIGS. 26 and 27A, the details of the piercing hub 80 are shown. FIG. 26 shows the piercing hub 80 from the front, and FIG. 27A shows it enlarged from the back. As described above, the downfall wheel drive nub 132 (shown in FIG. 26) serves to rotate the hub 80 about the hub rotation axis 138. Each time the downfall wheel 82 rotates 90 degrees clockwise (as seen in FIG. 26), one of the four drive nubs 132 engages the hub cam 140 to drive the hub 80 through 77.29 degrees about its own axis offset from the downfall wheel rotation axis. In this embodiment, the rotation ratio between the downfall wheel and the hub 80 is not linear. As the hub 80 rotates, a pair of piercing pins or sharp portions 94 (one in the front and one in the back, so only one is visible in FIGS. 26 and 27A) are advanced into the capsule 142. The hub cam 140 may be shaped as shown so that the piercing pins 94 can track each capsule as it moves upward within the downfall wheel 82 from position 1 (shown in FIG. 17) towards the swivel chamber 106. In this case, the pins 94 generally continue to be oriented along the diameter of the capsule 142 as the capsule moves. As the hub 80 rotates, the hub spring 78 is wound more tightly. The capsule 142 is advanced from the pins when the downfall wheel 82 pushes up the aforementioned inclined portion by its rotation. This occurs before the hub 80 returns to its starting position. As the downfall wheel 82 approaches the end of its 90-degree stroke, the tip of the cam arm 140 clears the drive nub 132, allowing the hub spring 78 to rotate the hub 80 back to its starting position as shown. When the hub 80 returns to its starting position, the cam 140 can engage the next drive nub 132 and repeat the piercing process with the next capsule. This automatic piercing sequence will be described in more detail below.

[0071] Referring to FIGS. 27B - 27E, enlarged views of the capsule puncture component and other internal components are shown. In particular, FIG. 27B shows the puncture hub 80, the downfall wheel 82, and related components. FIG. 27C shows the downfall wheel 82 and labels its four capsule recesses and four drive nubs. FIG. 27D shows the puncture hub 80 and its cam function and profile. FIG. 27E shows a portion of the dose count wheel 70 and its cam function and profile.

[0072] Referring to FIGS. 27F - 27O, the puncture hub 80 and the downfall wheel 82 are shown in a series of states as they go through the puncture cycle. These figures show the capsule alignment mechanism sequence, the automatic puncture mechanism sequence, and the dose counter mechanism sequence of this embodiment.

[0073] Starting from FIG. 27F, the automatic puncture mechanism is shown in an initial position where capsule positions 1, 2, and 3 are identified. As shown, the clearance between the tip of the puncture pin 94 and the capsule at position 1 is such that the pin does not contact capsule 2 before capsule 2 moves to the puncture position. At this initial position, drive nub #4 has just started to contact the cam of the puncture hub 80, and the carousel 74 and the dose count wheel 70 are at the "30" dose remaining position (not shown).

[0074] In FIG. 27G, the downfall wheel 82 has rotated counterclockwise enough for the drive nub 132 to rotate the hub 80 counterclockwise until the tip of the puncture pin contacts the hemispherical end of capsule 1.

[0075] FIG. 27H shows further advancement of the downfall wheel 82 such that the puncture pin 94 has entered capsule 1. As the downfall wheel 82 and the pin hub 80 continue to rotate, the insertion depth continues to increase. Here, drive nub #3 is in contact with one of the cam surfaces of the dose wheel 70.

[0076] Figure 27I shows the point in the piercing cycle where the pins reach their theoretical maximum insertion depth. Capsule #1 is pressed against the inner surface of the chassis 76 to maximize the pin insertion depth. The carousel 74 and the dose count wheel 70 are driven by the nub #3 of the downfall wheel 82 and continue to rotate clockwise. Capsule #3 begins to rise toward the downfall wheel capsule recess #3.

[0077] In Figure 27J, capsule #1 contacts the lower end of the chassis ramp that helps lift it into the swivel chamber 106. The dose count wheel 70 is driven by the downfall wheel nub #3 and continues to rotate clockwise. The downfall wheel nub #4 continues to rotate the hub 80 counterclockwise via the cam arm. The carousel 74 pushes capsule #3 up to the lower ramp toward the downfall wheel capsule recess #3.

[0078] In Figure 27K, the downfall wheel nub #4 is sliding along the outer cam profile of the hub 80 to hold the hub in the raised position as shown.

[0079] Figure 27L shows that the downfall wheel 82 has rotated further counterclockwise from its position in Figure 27K, while the hub 80 remains in the same position. At this position, the downfall wheel 82 has rotated to the end of its holding rotation phase (i.e., the nub #4 has reached the lower end of the outer cam profile of the hub 80). Further rotation of the downfall wheel 82 is pushing capsule #1 partway away from the pin 94 and up the upper ramp into the swivel chamber 106.

[0080] Figure 27M shows the hub 80 after the downfall wheel nub #4 has cleared the hub cam profile and the hub 80 has automatically returned to its initial rest position (driven by the torsion spring 78 shown in Figure 26).

[0081] Figure 27N shows that the downfall wheel 82 has advanced further, and the dose count wheel 70 has been aligned with the next position, 22.5° clockwise from its starting position. Further counterclockwise rotation of the downfall wheel 82 causes the drive nub #3 to skip over the upper end of the dose counter wheel cam profile.

[0082] In Figure 27O, the automatically punctured capsule #1 has been delivered to the swivel chamber 106. Here, the downfall wheel 82 is reset to the inhalation position where the downfall wheel surface 131 blocks the lower end of the swivel chamber 106. The carousel 74 and the dose counter wheel 70 are here in the "29" dose remaining position, and are set so that the capsule alignment, automatic puncturing, and dose counting sequence start again.

[0083] Figure 27P shows a representative drug capsule after both hemispherical ends have been automatically punctured as described above.

[0084] Referring to FIGS. 28A-46D, the configuration and operation of the mouthpiece cover interlock latch are shown. As previously described with reference to FIG. 15, in this exemplary embodiment, after the user inhales a dose from the device 50, the mouthpiece cover 62 can be moved to its closed position on the mouthpiece 56, but will not spring back to the open position and remain there unless the mouthpiece 56 is first opened and closed. This notifies the user that the empty capsule remaining in the swivel chamber needs to be discarded before closing the device 50 and removing it, thereby preparing the device for the next inhalation cycle.

[0085] As best seen in FIGS. 43B and 46A - 46D, the locking arm 84 moves vertically between two states: an upper position 1 where the mouthpiece cover can be closed, thereby preparing the device for the next cycle; and a lower position 2 where the mouthpiece cover remains open and the next cycle is not initiated. As shown in FIGS. 28A - 46D, when the mouthpiece cover 62 is open, the downfall wheel cam surface 146 (best seen in FIGS. 35A and 35B) drives the locking arm 84 downward from position 1 to position 2, and when the mouthpiece 56 is open, the mouthpiece tab 144 (best seen in FIGS. 44 and 46A - 46D) drives the locking arm 84 upward from position 2 to position 1. Further details are provided in FIGS. 28A - 46D.

[0086] In some embodiments (not shown), the mouthpiece cover may be opened and closed, and the inhalation device may be configured without the aforementioned interlock mechanism such that other drug delivery cycles are initiated regardless of whether the mouthpiece was first opened or closed.

[0087] In the exemplary embodiments disclosed herein, the inhalation device 50 is configured such that a user can hold the device in one hand and operate all of its functions or hold the device in one hand and operate the device with the other hand. The cost of the articles for the device 50 is such that after all of its capsules are depleted, it can be recycled or disposed of in other ways. In some embodiments, the device 50 may be reloaded with new capsules and reused after cleaning and / or sterilizing the device 50. In some implementations, the inhalation device may be configured such that an empty carousel, cartridge, or other capsule carrier device can be easily removed from the inhalation device by an end - user or provider of the inhalation device and replaced with a full capsule carrier device.

[0088] Smart Device Components In some embodiments, a "smart device" functionality may be incorporated into the inhalation device 50. For example, the device 50 may be configured to record time, date, location, remaining doses, and / or user input each time an administration cycle starts and / or ends. Some or all of this data and / or additional data may be stored in the device for later retrieval or transmitted wired or wirelessly to another device such as a smartphone, tablet, laptop computer, desktop computer, computer network, or other device. Data recording and / or transmission events may be triggered by opening and closing the mouthpiece cover, opening and closing the mouthpiece, automatically sensing the airflow through the mouthpiece, user input, a preset time, and / or one or more other triggers. These events may be referred to as "delivery signatures" triggered by a "deflection component" that actuates a "sensor component" such as a cam surface that actuates a microswitch. Each of these components is described in further detail herein.

[0089] Sensor component As described above, aspects of the present disclosure include systems and devices comprising sensor components. Sensor components according to embodiments of the present disclosure are configured to obtain one or more data inputs from or in the immediate vicinity of a target system and device and transmit a report including a drug dose completion signal when a delivery signature is detected. In certain embodiments, the report transmitted by the sensor component includes additional information such as, for example, one or more drug identification characteristics (described further herein).

[0090] In some embodiments, the sensor component may include an acoustic sensor (e.g., a microphone) or a pressure sensor for detecting data related to the quality of inhalation (e.g., peak flow, average flow, peak pressure, inhaled volume, inhalation duration, etc.).

[0091] In some embodiments, the sensor component includes a circuit board component configured or adapted to mechanically support and electrically connect one or more electronic components of the sensor of interest. Circuit board components according to embodiments of the present disclosure can include, but are not limited to, printed circuit boards, etched circuit boards, flexible circuit boards, or any combination thereof. In some embodiments, the circuit board component comprises a printed circuit board (PCB).

[0092] Circuit board components according to embodiments of the present disclosure can comprise conductive tracks, pads, or other features etched from a conductive sheet (e.g., a copper sheet) attached to a non-conductive substrate. In certain embodiments, standard circuit components such as capacitors, resistors, memory components, etc. are electrically connected to the circuit board component (e.g., soldered to the PCB). The connection of one or more electronic circuit components to the PCB results in a printed circuit assembly (PCA) or printed circuit board assembly (PCBA), and these terms are used interchangeably herein.

[0093] Aspects of the present disclosure include switches configured to establish or break electrical contacts within a circuit board component of interest in response to an external stimulus (e.g., in response to an external mechanical stimulus). In some embodiments, the circuit board component comprises a momentary contact switch configured to establish or break electrical contacts only while the momentary contact switch is in an activated state. In some embodiments, the circuit board component comprises a non-momentary contact switch configured to establish or break electrical contacts until the non-momentary switch is activated again.

[0094] In some embodiments, the sensor component comprises a position sensor configured or adapted to enable measurement of the position of one or more components of the subject drug delivery system and device. For example, in some embodiments, the position sensor is configured to detect and / or measure the position of an actuating component and / or a deflecting component. In some embodiments, the position sensor is configured to detect the orientation of one or more components of the subject device. The position sensors according to embodiments of the present disclosure can be absolute position sensors or relative position sensors, and can be linear, angular, or multi-axis position sensors. In some embodiments, the position sensor is configured to measure the position of one or more components of the subject system or device over a defined time interval, as a function of time, or as a function of the progression of the drug delivery procedure, or to acquire multiple measurements during the execution of the drug delivery procedure.

[0095] In some embodiments, the sensor component and / or the deflecting component comprises a force sensor configured or adapted to detect and / or measure one or more forces within one or more components of the subject drug delivery system and device. The force sensors according to embodiments of the present disclosure can be absolute force sensors or relative force sensors. Non-limiting examples of force sensors include electrical resistance strain gauges, elastic strain gauges, foil strain gauges, semiconductor strain gauges, thin film strain gauges, wire strain gauges, piezoelectric transducers, strain gauge load cells, inductive sensors, and the like.

[0096] In some embodiments, the sensor component comprises a light sensor configured or adapted to detect and / or measure ambient light. For example, in some embodiments, the light sensor is configured to determine whether the amount of ambient light in the vicinity of the subject drug delivery system or device exceeds a predetermined threshold. The light sensors according to embodiments of the present disclosure can be absolute light sensors or relative light sensors. In some embodiments, the light sensor is used to detect an increase in ambient light, thereby indicating that the subject device has been removed from its packaging, removed from a storage container, and / or removed from a dark location.

[0097] In some embodiments, the sensor component comprises a motion sensor configured or adapted to detect and / or measure the movement of a target drug delivery system or device. For example, in some embodiments, the motion sensor is configured to determine whether the device or a component thereof has moved beyond a predetermined threshold. The motion sensor according to embodiments of the present disclosure can be an absolute motion sensor or a relative motion sensor. In some embodiments, the motion sensor is used to detect the movement of the target device, thereby indicating that the user has started to interact with the device.

[0098] In some embodiments, the sensor component comprises a temperature sensor configured or adapted to detect and / or measure the temperature of one or more components of the target system or device. For example, in some embodiments, the temperature sensor is configured to determine whether the temperature of the drug is above a predetermined threshold or within a predetermined temperature range. The temperature sensor according to embodiments of the present disclosure can be an absolute temperature sensor or a relative temperature sensor. In some embodiments, the temperature sensor is used to detect an increase in temperature, thereby indicating that the target device has been removed from the cooler and has reached a temperature suitable for drug administration to a patient. In some embodiments, the temperature sensor is used to determine when the cold chain has been broken (i.e., when the temperature of the device or a part thereof has risen above a predetermined threshold temperature) and to record this information. In some embodiments, the temperature sensor is used to track when the device or a part thereof has risen above a predetermined threshold temperature and to wake up the device when the temperature reaches the predetermined threshold temperature to record the absorption procedure. Any information regarding the cold chain of the device can be recorded and used for the purpose of information tracking and / or preparing the device for use. In some embodiments, the device is configured to wake up from a deep sleep, read the temperature from the sensor, and return to sleep. This process may be performed at a low power level once per minute or at another frequency to enable long-term storage of the device. In some embodiments, this process can be performed for up to five years with a single battery due to the high-speed operation of the microprocessor and the selective powering of only the circuit components necessary to read the temperature.

[0099] In some embodiments, the sensor component comprises a touch sensor configured or adapted to detect and / or measure contact by an object that is conductive or has a dielectric value different from air. In some embodiments, the touch sensor comprises one or more detection components (e.g., a capacitive sensing component) disposed proximate to or within the inner surface of the outer surface of the target drug delivery system or device and electrically connected to the touch sensor. When the user touches the detection component, an electrical signal indicating that the user has touched the device is transmitted to the touch sensor. In some embodiments, the touch sensor is used to determine that the user has physically contacted the target device (e.g., a part of the user's skin has physically contacted the target device), thereby indicating that the user has initiated an interaction with the device.

[0100] Aspects of the target sensor component include a power supply component configured or adapted to supply power to the sensor component. In some embodiments, the power supply component comprises a battery. In some embodiments, the power supply component comprises a rechargeable battery. For example, in certain embodiments where one or more components are disposable, the power supply component does not include a rechargeable battery. In some embodiments, the power supply component comprises one or more standard electrical cords configured to supply power to the sensor component by establishing electrical contact with an external power source (e.g., a standard electrical outlet). In some embodiments, the target system or device comprises an on / off switch or button that can be used to turn the power of the system or device on or off as needed.

[0101] In some embodiments, the sensor component comprises a memory component configured or adapted to store one or more drug identification characteristics therein. The memory component according to embodiments of the present disclosure can be a volatile or non-volatile memory component. In some embodiments, the memory component is encoded with one or more drug identification characteristics before it is connected to the sensor component (e.g., the memory component is encoded with one or more drug identification characteristics when the memory component is manufactured). In some embodiments, the memory component is encoded with one or more drug identification characteristics after the memory component is connected to the sensor component. In certain embodiments, the sensor component comprises a data acquisition component configured to obtain one or more drug identification characteristics stored in the memory component from an external source (e.g., from an external encoder, or from a memory component on a drug carousel or cartridge). In some embodiments, the memory component is configured to receive the encoded information wirelessly (e.g., the data acquisition component is configured to obtain one or more drug identification characteristics wirelessly). In some embodiments, the sensor component comprises a near field communication (NFC) component and / or a radio frequency identification (RFID) component configured for data exchange.

[0102] The drug identification characteristics according to embodiments of the present disclosure broadly include any information regarding the identity and / or biochemical characteristics of a drug (including, but not limited to, the name, concentration, dosage, dose, serial number, lot number, universal unique identifier (UUID), expiration date, manufacturing date, manufacturing location, or any combination thereof). In some embodiments, the memory component can further include one or more patient identification characteristics (including, but not limited to, patient name, patient identification number, prescription number, demographic information, patient group or subgroup, or any combination thereof). In some embodiments, the memory component can further include one or more drug delivery device identification characteristics (including, but not limited to, the name, type, model number, serial number, lot number, manufacturing date, manufacturing location, UUID, or any combination thereof). In some embodiments, the memory component is configured to be programmed using wireless transmission with a universal unique identifier (UUID) (e.g., during device manufacture).

[0103] Aspects of the sensor component of interest include a wireless transmitter module configured to wirelessly transmit data to a network device (e.g., a data management component). In some embodiments, the network device is a secure network device. In some embodiments, the data to be transmitted can be encrypted. In some embodiments, the wireless transmitter module is configured to communicate with one or more network devices using a wireless transmission component (e.g., a communication link that utilizes infrared, radio frequency, light wave, or ultrasonic wave, or any combination thereof). The network devices according to embodiments of the present disclosure broadly include any device or component that communicates with at least one other device via a communication link. Non-limiting examples of network devices include, for example, mobile computing devices (e.g., smartphones, laptop computers) that use Bluetooth, Bluetooth low energy (BLE), or Wi-Fi connections. In some embodiments, the wireless transmitter module is configured to wirelessly communicate directly with a network or directly with a remote computing device (i.e., without first communicating with a mobile computing device). In certain embodiments, the wireless transmitter module includes an antenna. Aspects of the present disclosure broadly include any radio spectrum communication system that can communicate to a central hub and then to a cloud-based computing / data transmission environment, but are not limited thereto.

[0104] Sensor components according to embodiments of the present disclosure are configured to transmit a report including a drug dosage completion signal when the sensor component detects a delivery signature. In some embodiments, the drug dosage completion signal includes an indication that an actuating component has completed a delivery stroke. In some embodiments, a data management component is configured to determine the amount of drug delivered to a patient by identifying a drug delivery system or device and determining the amount of drug administered in a single delivery stroke of the identified system or device. In some embodiments, the data management component is encoded, for example, with information regarding the amount of drug administered in a single delivery cycle of a specified system or device.

[0105] In some embodiments, a sensor component of interest is configured or adapted to determine one or more operating states of a drug delivery system or device. For example, in some embodiments, the sensor component is configured to determine a ready state in which the system or device is ready to administer a drug dosage to a patient. In some embodiments, the sensor component is configured to determine a not-ready state in which the system or device is not ready to administer a drug dosage to a patient. In some embodiments, the sensor component is configured to determine an administering state in which the system or device is actively administering a drug dosage to a patient. In some embodiments, the system or device of interest is configured to administer a drug dosage to a patient over a time frame ranging from about 1 second to about 30 minutes, such as about 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, or 60 seconds, or about 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10 minutes or more, such as about 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, or 29 minutes or more. In some embodiments, the system or device of interest is configured to maintain an administering operating state for a period equal to the time frame for administering the drug to the patient.

[0106] In some embodiments, the sensor component is configured to determine a sleep mode state (e.g., a low power state) in which the system or device is operating in a low power mode and not ready to administer a drug dose to a patient. In some embodiments, the sensor component is configured to determine a low battery state in which the battery level is below a predetermined level.

[0107] Determination of any of the states described herein can be achieved by analysis of one or more inputs from one or more of the subject sensor components. For example, in some embodiments, when a temperature value from a temperature sensor falls within a predetermined range (i.e., indicating that the drug is in a temperature range desirable for administration) and a position sensor indicates that the system or device is in a position or orientation desirable for administration (e.g., the position of the actuating component is determined to be correct for drug administration to a patient), a ready state can be determined. Also, this configuration can be used to train the user regarding the orientation of the correct "inhalation posture". In some embodiments, this may be done in conjunction with the orientation of the correct inhalation posture shown on the graphical user interface of the user's mobile device.

[0108] In some embodiments, the sensor component can communicate the determined operating state to other components of the system or device (e.g., a data management component), as described above. In certain embodiments, the data management component can then indicate the operating state to the user (e.g., on a GUI), thereby communicating the operating state to the user. In some embodiments, as further described herein, the subject system and device can include one or more indicator components configured to communicate the operating state of the system or device (e.g., a "ready to inhale" operating state) to the user.

[0109] The sensor components according to embodiments of the present disclosure can be mounted at any suitable position on a target system or device. For example, in some embodiments, the sensor components can be mounted to a housing located anywhere on the system or device. In certain embodiments, the sensor components are formed as a single unit. In certain embodiments, the sensor components include two or more individual units (e.g., two or more different PCBA) that are electrically connected to each other, and each of them is mounted at a suitable position of the target drug delivery system or device.

[0110] Deflection component Aspects of the present disclosure include one or more deflection components configured to generate a delivery signature when a delivery stroke is completed. The target drug delivery system and device are configured to transmit a report including a drug dose completion signal only when a delivery signature is generated and detected.

[0111] The deflection components according to embodiments of the present disclosure can be positioned at any suitable position on a target system or device so as to be able to interact with one or more components of the target system or device during the execution of a delivery cycle. In some embodiments, the deflection components are positioned along the length of an actuating component and are configured to be mechanically deflected by at least a portion of the system or device during a delivery cycle. In some embodiments, the deflection components include a force sensor configured to measure one or more forces applied by a user to a portion of the target system or device. In some embodiments, the deflection components include one or more inductive sensor coils configured to move towards one or more detection targets in response to a force applied to one or more components of the target system or device.

[0112] As outlined above, in some embodiments, the deflection components include a force sensor. The force sensors according to embodiments of the present disclosure can be absolute force sensors or relative force sensors, and details of such sensors are generally known in the art.

[0113] In certain embodiments, the deflection component comprises one or more inductive sensor coils configured to move toward a detection target in response to a force applied to a portion of the system and device of interest during a delivery stroke. The inductive sensor coils according to embodiments of the present disclosure generally operate by generating an alternating electric field capable of detecting a conductive material within a particular proximity of the inductive sensor coil. Thus, the inductive sensor coils according to embodiments of the present disclosure generally operate with one or more detection targets including a conductive material (e.g., a conductive metal material). The configuration of the inductive sensor coil and its detection target can take any suitable configuration. For example, in some embodiments, a first inductive sensor coil is disposed at a base portion of the deflection component, and the base portion is configured to deflect toward the detection target when a force is applied to the base portion by a user during a delivery stroke. In some embodiments, the inductive sensor coil is disposed on an extending component configured to move through a portion of the device of interest during a delivery stroke and configured to pass over one or more portions of the detection target during the delivery stroke.

[0114] The detection targets according to embodiments of the present disclosure can have any number of different shapes. For example, in some embodiments, the detection target has a uniform geometric shape that does not vary significantly depending on its position in a given direction. Non-limiting examples of uniform geometric shape detection targets include geometric shapes such as rings, bands, rectangles, and squares. In some embodiments, the uniform geometric shape detection target can be disposed on the inner or outer surface of the device of interest and can be detected when the inductive sensor coil passes over and / or moves toward the detection target. In certain embodiments, the detection target with a uniform geometric shape is disposed over at least half of the surface of the system or device of interest.

[0115] In some embodiments, the detection target has a repetitive geometry, and two or more uniform geometric detection targets are repeatedly arranged in a given direction along the surface of the device of interest. For example, in some embodiments, two or more circular or square detection targets can be arranged in series along the length of the device component. When the induction sensor coil passes through each uniform target, the progress of the delivery stroke can be determined.

[0116] In some embodiments, the detection target has a variable geometry, and one or more dimensions of the detection target vary according to the position in a given direction. For example, in some embodiments, the variable detection target includes a conductive material that begins with a minimum width at the first end of the device component and the width gradually increases along the length of the component to a final maximum width at the other end of the component. Any number of variations in the variable geometry can be introduced to generate a unique reading or signature obtained when the induction sensor coil passes through the variable geometry detection target.

[0117] Delivery signature As described above, aspects of the present disclosure include the detection of delivery signatures by the sensor and / or data management components of interest. The delivery signature according to an embodiment can comprise any of a variety of data components. For example, in an embodiment where the deflection component comprises a plurality of trigger switches, the delivery signature can include data regarding the deflection order of the trigger switches, the deflection duration of each trigger switch, one or more time intervals corresponding to the time between the deflection of the first trigger switch and the deflection of the second trigger switch, or any combination thereof.

[0118] In embodiments where the biasing component comprises first and second inductive sensor coils and first and second detection targets, the delivery signature can include detection signals from the first and second inductive sensor coils corresponding to the detection of the first and second detection targets. In such embodiments, where the second detection target includes a uniform geometric shape, the delivery signature can include detection of the uniform geometric shape of the second detection target by the second inductive sensor coil that can be positioned on the extending component of the biasing component. Further, in such embodiments where the second detection target includes a repeating geometric shape, the delivery signature can include detection of the repeating geometric shape by the second inductive sensor coil that can be positioned on the extending component of the biasing component. Further, in embodiments where the detection target includes a variable geometric shape, the delivery signature can include detection signals from one or more attributes of the variable geometric shape, such as a proportional signal.

[0119] The delivery signature according to embodiments of the present disclosure can have a characteristic shape indicative of an inhalation profile. Aspects of the present disclosure include detecting all or a portion of the delivery signature to measure the progression or completion of a delivery profile. In some embodiments, the delivery signature is detected and / or analyzed by a sensor component. In some embodiments, the delivery signature is detected and / or analyzed by a data management component. In some embodiments, the delivery signature is compared to a reference signature, and if the delivery signature matches the reference signature within an acceptable tolerance level, a successful delivery profile is recorded. In some embodiments, the data management component is programmed with one or more algorithms adapted to apply a set of rules to determine whether the delivery signature sufficiently conforms to a predetermined reference signature.

[0120] In one embodiment, a delivery signature is generated when a plurality of trigger switches are deflected in a given direction over a specified period of time. For example, when all of the trigger switches within a trigger switch assembly are deflected over a specified period of time (e.g., 3 seconds or more, e.g., 4, 5, 6, 7, 8, 9, and 10 seconds or more), the data management component determines that the delivery signature conforms to a reference signature.

[0121] Actuating component Aspects of the present disclosure include an actuating component configured to move, thereby dispensing a capsule from a capsule space into a swivel chamber. The actuating component according to embodiments of the present disclosure can generally be actuated by any suitable mechanism. In some embodiments, the actuating component is configured to be manually moved by a user. In some embodiments, the actuating component is configured to be automatically moved by one or more driver components (e.g., one or more mechanical, electrical, or electromechanical controllers).

[0122] In some embodiments, the actuating component can include a controller coupled to one or more assemblies or subassemblies of a target system or device. The controller can be configured or adapted to move the actuating component in response to a user input or activation signal (e.g., programmed if the controller includes electrical or electromechanical components).

[0123] In some embodiments, the actuating component can comprise one or more coupling components configured or adapted to mechanically connect the actuating component to one or more additional components of a target system or device. The coupling components according to embodiments of the present disclosure broadly include screw couplers, adhesive couplers, snap-fit couplers, magnetic couplers, or any combination thereof.

[0124] Indicator component Aspects of the present disclosure include an indicator component configured or adapted to communicate to a user one or more operating states of a target drug delivery system or device. In use, a particular indicator signal can be assigned to a given operating state of the target drug delivery system or device, and the particular indicator signal can be communicated to the user using the target indicator component, thereby indicating to the user that the system or device is in the indicated operating state. Indicator components according to embodiments of the present disclosure broadly include visual, tactile, and auditory indicators, each of which is described in further detail herein.

[0125] Aspects of the present disclosure include a visual indicator component configured or adapted to display to a user a visual signal regarding the operating state of a target system or device. In some embodiments, the visual indicator comprises a light-emitting component. Light-emitting components according to embodiments of the present disclosure include, but are not limited to, light-emitting diodes (LEDs) and organic light-emitting diodes (OLEDs). In some embodiments, the visual indicator comprises an optical pipe (also referred to as an optical tube). In some embodiments, the optical pipe comprises a hollow structure configured to contain light within the structure by utilizing a reflective lining. In some embodiments, the optical pipe comprises a transparent solid material configured to contain light within the material by utilizing total internal reflection. In some embodiments, the visual indicator comprises a diffuser component (e.g., an optical pipe diffuser) configured to evenly spread a visual signal (e.g., light from an LED) over a defined area. In some embodiments, the visual indicator component comprises an optical pipe and an optical pipe diffuser. The visual indicator component according to embodiments of the present disclosure can be configured or adapted to generate a visual signal having any color (e.g., red, orange, yellow, green, blue, purple) or any combination thereof. In some embodiments, a specific color can be assigned to the operating state of the target system or device. For example, in one embodiment, red is assigned to the unprepared operating state, and when the system or device is in the unprepared state, red is displayed to the user using the visual indicator component. In some embodiments, the visual indicator component can be configured to blink the visual indicator in a specific sequence (e.g., a series of three short flashes) or to remain on constantly to provide an indication of the operating state. Other indicator settings according to embodiments of the present disclosure include attempting to connect to a data management component (e.g., a blinking yellow or blue indicator light), and attempting to connect to a data management component (e.g., a blinking or solid green or blue indicator light). Any of various "ready" or "unready" states can be indicated to the user.For example, in some embodiments, the indicator component is configured to indicate that the capsule storage component has reached a temperature suitable for use. In some embodiments, the indicator component is configured to indicate to the user that the device is attempting to connect to a wireless network or a data management component. In some embodiments, the indicator component is configured to indicate to the user that the device is connected to a wireless network or a data management component. In some embodiments, the indicator component may be located on the GUI of the mobile device.

[0126] Aspects of the present disclosure include a tactile indicator component configured or adapted to generate one or more vibration signals specific to the operating state of the system or device of interest. In some embodiments, the tactile indicator includes a vibration generator component. The vibration generator component according to an embodiment of the present disclosure is configured or adapted to generate vibrations having any desired combination of amplitude, frequency, and duration to generate a plurality of unique vibration signals. For example, in one embodiment, a vibration signal consisting of a single high-amplitude vibration having a duration of 1 second can be assigned to the unprepared operating state.

[0127] Aspects of the present disclosure include an auditory indicator component configured or adapted to generate one or more auditory signals specific to the operating state of the system or device of interest. In some embodiments, the auditory indicator includes a sound generator component. The sound generator component according to an embodiment of the present disclosure is configured or adapted to generate a plurality of unique sounds having a plurality of different tones and / or volumes. For example, in one embodiment, a sound consisting of a single loud buzzer sound can be assigned to the unprepared operating state.

[0128] The indicator component according to an embodiment of the present disclosure can be mounted at any suitable position on a target system or device. For example, in some embodiments, the indicator component can be mounted on a housing located at any location of the system or device. In some embodiments, the indicator component can include a plurality of individual components that cooperate to generate a desired indicator signal. For example, in one embodiment, the visual indicator component includes an LED that generates a visible light signal and also includes an optical pipe that transmits the visible light from the LED to one or more positions on the target system or device. In some embodiments, the visual indicator further includes an optical pipe diffuser that spreads the visible light signal uniformly over a desired position (e.g., over the entire indicator window).

[0129] Housing component Aspects of the present disclosure include one or more housing components formed from suitable materials such as, for example, ceramic, plastic, metal, or any combination thereof. In some embodiments, one or more individual components of a target drug delivery system or device can be located within a single housing and formed into a single unit. In some embodiments, one or more components of a target system or device can be located in a first housing component, and one or more additional components of the target system or device can be located in a second housing component, and the first and second housing components can be operatively coupled to each other to form a single unit.

[0130] In some embodiments, the housing includes one or more transparent or translucent windows made of a material configured to at least partially transmit light and allow ambient light to pass through the housing and reach a light sensor located within the housing. In some embodiments, the housing includes one or more windows or openings that allow one or more components of the system or device to physically pass through.

[0131] Data management component Aspects of the present disclosure include data management components configured or adapted to communicate with a target system or device and / or a user, e.g., to receive a report including a drug dosage completion signal from the target system or device, to send one or more commands to the target system or device, or to send a reminder to the user that a drug dosage is to be administered at a certain point in time. In some embodiments, the data management component comprises a computer (e.g., a personal computer, a network computer, or a network server). In some embodiments, the data management device comprises a mobile computing device (e.g., a smartphone or a laptop computer). In some embodiments, the data management component is an Internet-enabled device capable of sending and receiving information via the Internet. In some embodiments, the data management component comprises an application configured to manage one or more aspects related to the administration of a drug to a user (e.g., recording the administration of individual drug dosages to a patient, reminding the patient regarding future drug dosage administrations, verifying one or more drug identification characteristics by interacting with a remote database, etc.). In some embodiments, the data management component is configured to indicate to the user that one or more communication components are operating and / or are connected to one or more additional components of the target drug delivery system or device. For example, in some embodiments, the data management component is configured to indicate to the user that the data management component is connected to the target drug delivery system or device (e.g., via a Bluetooth or Wi-Fi connection). In some embodiments, as described above, one or more indicator components on the target drug delivery system or device may further be used to indicate to the user that the data management component is connected to the system or device.Using any suitable combination of indicator components on the data management component and / or other components of the system or device, the connection status of the data management component (e.g., connected, attempting to connect, not connected, disconnected, etc.) can be shown to the user.

[0132] In some embodiments, the data management component is configured or adapted to receive reports from the target drug delivery system or device and record one or more aspects of the reports for the purpose of maintaining the patient's medical record / history. For example, in some embodiments, the data management component is configured to receive from the system or device a report indicating that a drug dose has been administered to a patient, and the data management component records the administration of the drug dose including the date and time when the drug dose was delivered. In some embodiments, the report can include, for example, further information about the drug administered or the patient who received the drug. In some embodiments, the report can include information about one or more operating states of the target system or device. For example, in some embodiments, the report can include information about, for example, the temperature or temperature history of the system or device. In some embodiments, the report includes information about the geographical location of the drug delivery system at the time of administration.

[0133] In some embodiments, the data management component is configured or adapted to receive one or more data inputs from the target system or device and verify the one or more data inputs before proceeding with the administration of the drug to the patient. For example, in some embodiments, the data management component is configured to receive drug identification characteristics from the target system or device and verify that the drug identification characteristics are valid before proceeding with the administration of the drug to the patient. In some embodiments, the data management component is configured to transmit one or more drug identification characteristics to a remote database via the Internet and receive an authentication signal in response before administering the drug to the patient.

[0134] In some embodiments, the data management component is configured or adapted to receive one or more data inputs from a target system or device and analyze the received data to determine whether a delivery stroke has been completed. For example, in some embodiments, the target system or device transmits data to the data management component from a deflection component and / or sensor, analyzes the received data, and compares the received data with one or more stored delivery signature parameters (e.g., a reference delivery signature) to determine whether the received data corresponds to the delivery signature of the device.

[0135] In some embodiments, the data management component is configured or adapted to determine whether a particular drug delivery system or device, or a component thereof, is the result of an approved sale from a manufacturer and / or an approved drug prescription from a prescribing healthcare provider (e.g., a prescribing physician) at a particular geographical location (e.g., in a particular country). For example, in some embodiments, the data management component is configured to receive one or more drug identification characteristics from a target drug delivery system or device (or a component thereof, such as a drug carousel or cartridge) and transmit the one or more drug identification characteristics to a remote database. In some embodiments, the data management component is further configured or adapted to transmit the geographical location of the drug delivery system or device to the remote database. In some embodiments, the remote database is configured or adapted to compare the one or more drug identification characteristics received from the data management component with the geographical location and determine whether a particular drug delivery system or device, or a component thereof (e.g., a drug capsule carousel or cartridge), is being used at the geographical location where it was sold (e.g., a particular country).

[0136] In some embodiments, the data management component is configured to verify one or more operating states of the target system or device prior to administration of the drug to the patient. For example, in one embodiment, the data management component is configured to determine whether the drug capsule is at a temperature within a predetermined acceptable temperature range prior to administering the drug to the patient. In some embodiments, the data management component is configured to verify that the target system or device is in a "ready" operating state prior to administering the drug to the patient.

[0137] The data management component according to embodiments of the present disclosure is configured to determine the date and time at which the drug is administered to the patient (e.g., the timestamp of the drug dose administration). In some embodiments, the data management component is configured to receive a drug dose completion signal from the target system or device and to determine the exact time of drug administration based on further information transmitted from the system or device. For example, in some situations, the target system or device may not be operably connected to the data management component at the specific date and time at which the drug is administered. In such cases, the target system or device is configured to determine the elapsed time since the completion of the drug administration procedure. When the system or device is connected to the data management component, the drug dose delivery signal as well as the elapsed time since administration are transmitted to the data management component. The data management component then uses the transmitted information to back-calculate the specific date and time at which the drug administration procedure was completed and records this information in the patient's record.

[0138] Controller, Processor, and Computer-Readable Medium In some embodiments, a system or device of interest can include a controller, a processor, and a computer-readable medium configured or adapted to control or operate one or more components of the system or device of interest. In some embodiments, a system or device includes a controller configured to communicate with one or more components of the system or device of interest, control aspects of the system or device, and / or perform one or more operations or functions of the system or device of interest. In some embodiments, a system or device includes a processor and a computer-readable medium that can include a memory medium and / or a storage medium. An application and / or an operating system embodied as computer-readable instructions on a computer-readable memory can be executed by the processor to provide some or all of the functions described herein.

[0139] In some embodiments, a system or device of interest includes a user interface, such as a graphical user interface (GUI), configured or adapted to receive input from a user and perform one or more of the methods further described herein. In some embodiments, the GUI is configured to display data or information to the user.

[0140] Energy harvesting Aspects of the present disclosure include an energy harvesting system coupled to a drug delivery device disclosed herein. The use of the energy harvesting system allows the drug delivery device to harvest energy from its surroundings and power the onboard communication electronics. This reduces or eliminates the need for a battery disposed on the device. As a result, this reduces the issues associated with the disposal of environmentally friendly devices, which are often of the disposable type. In some embodiments, mechanical energy is stored in a spring or similar means, and this energy is recaptured during use, such as at the end of an inhalation or drug delivery cycle. In some embodiments, the spring or other storage mechanism is converted to electrical energy, rectified and conditioned, and supplied to a generator that generates mechanical energy to power wireless transmission from the drug delivery device to a mobile device or a home-based receiver or hub. As described above, this wireless transmission can provide confirmation of drug delivery dose completion via smart device technology.

[0141] A self-powered drug delivery device can be wirelessly connected to a user's smartphone using various connection methods. These can be divided into the following direct and indirect methods.

[0142] Direct methods - Communication that does not require an external peripheral □ BLE - Master / Slave □ BLE - Non-connectable connection (Advertising) □ BLE - Scan response □ WiFi □ NFC (Near Field Communication) □ Cellular (Existing logistics) □ Audio (Utilizing ultrasonic identifiers)

[0143] Indirect methods - Communication that requires an external peripheral / infrastructure □ Internet (Web host) □ "Home hub" - RF (Local) □ "Home hub" - Backscatter □ "Remote Hub" - LoRaWAN, Sigfox, Narrowband Internet of Things (IoT)

[0144] In some embodiments of energy harvesting, Bluetooth Low Energy (BLE) may be selected as "not connectable" because it is a widely adopted and mature technology. In this approach, there is no need to initiate a connection between the device and the phone, thereby reducing power consumption. In some embodiments, at least 1.04 mJ needs to be delivered to the BLE module to perform the type of communication described herein. Due to the energy loss between the power generation device and the BLE module, in some embodiments, it is desirable to have a generator output of approximately 10 mJ.

[0145] According to aspects of the present disclosure, the energy harvesting source may be □ Ambient radiation □ Fluid flow □ Photovoltaic □ Piezoelectric □ Pyroelectric □ Thermoelectric □ Electrostatic □ Magnetic inductance □ Chemistry and may include.

[0146] In the magnetic inductance category, the energy harvesting source may be one of the following design configurations. □ Impulse energy harvester □ Floating magnetic harvester □ Cantilever beam harvester □ Axial flux generator □ Claw pole type micro generator

[0147] Further details of the above "smart device" functional parts can be found in co-pending and published US Patent Application Nos. 2019 / 0321555 and 2021 / 0046247, which are incorporated herein by reference.

[0148] When a feature or element is referred to in this specification as being "above" another feature or element, the feature or element can be directly above the other feature or element, or intervening features and / or elements may also be present. In contrast, when a feature or element is referred to as being "directly" on another feature or element, there are no intervening features or elements. When a feature or element is referred to as being "connected", "attached", or "coupled" to another feature or element, it is understood that it can be directly connected, attached, or coupled to the other feature or element, or intervening features or elements may be present. In contrast, when a feature or element is referred to as being "directly connected to", "directly attached to", or "directly coupled to" another feature or element, there are no intervening features or elements. Although described or shown with respect to one embodiment, the features and elements so described or shown can be applied to other embodiments. It is also to be understood by those skilled in the art that a structure or feature disposed "adjacent" to another feature can have an overlapping or underlying portion with respect to the adjacent feature.

[0149] The terms used in this specification are for the purpose of describing particular embodiments only and are not intended to limit the invention. For example, as used herein, the singular forms "a", "an", and "the" are intended to include the plural forms as well, unless the context indicates otherwise. The terms "comprise" and / or "comprising", when used in this specification, specify the presence of the stated features, steps, acts, elements, and / or components, but do not preclude the presence or addition of one or more other features, steps, acts, elements, components, and / or groups thereof. As used herein, the term "and / or" includes any and all combinations of one or more of the associated listed items and can be abbreviated as " / "

[0150] Spatially relative terms such as "under", "below", "lower", "over", "upper", etc. may be used herein to describe the relationship of one element or feature to another element or feature shown in the figures for ease of explanation. It should be understood that spatially related terms are intended to encompass different orientations of the device during use or operation in addition to the orientation depicted in the figures. For example, if the device in the figure is turned over, an element described as "under" or "below" another element or feature will be "over" the other element or feature. Thus, the exemplary term "under" can encompass both upward and downward orientations. The device may be otherwise oriented (rotated 90 degrees or in other directions), and the spatially related descriptors used herein will be interpreted accordingly. Similarly, terms such as "upwardly", "downwardly", "vertical", "horizontal", etc. are used herein only for purposes of explanation unless otherwise specified.

[0151] The terms "first" and "second" may be used herein to describe various features / elements (including steps), but these features / elements should not be limited by these terms unless the context dictates otherwise. These terms may be used to distinguish one feature / element from another. Thus, without departing from the teachings of the present disclosure, a first feature / element discussed below could be referred to as a second feature / element, and similarly, a second feature / element discussed below could be referred to as a first feature / element.

[0152] Throughout this specification and the following claims, unless the context requires otherwise, the word "comprise", and variations such as "comprises" and "comprising", are meant to imply that various components can be used together in a method and an article (e.g., a composition and an apparatus including devices and methods). For example, the term "comprise" is to be understood as suggesting the inclusion of any recited element or step and not the exclusion of any other element or step.

[0153] As used herein and in the claims, including those used in the examples, all numbers, unless specifically indicated otherwise, should be read as if they began with the word "about" or "approximately," even if the term is not explicitly stated. The phrases "about," "approximately," or "generally" may be used when describing a magnitude and / or position to indicate that the described value and / or position is within a reasonable expected range of the value and / or position. For example, a numerical value may have a value of + / -0.1% of the recited value (or range of values), + / -1% of the recited value (or range of values), + / -2% of the recited value (or range of values), + / -5% of the recited value (or range of values), + / -10% of the recited value (or range of values), etc. Any numerical value shown herein should also be understood to include approximately that value, unless the context indicates otherwise. For example, if the value "10" is disclosed, "about 10" is also disclosed. Any numerical range described herein is intended to include all sub-ranges subsumed therein. Also, as will be appropriately understood by those skilled in the art, when a value is disclosed as "less than," it is also understood that "greater than or equal to the value" and the possible ranges between the values are also disclosed. For example, if the value "X" is disclosed, "less than or equal to X" as well as "greater than or equal to X" (e.g., X is a numerical value) are also disclosed. Also, throughout this patent application, data is provided in many different formats, and it is understood that this data represents ranges of endpoints and starting points, and any combination of data points. For example, if a particular data point "10" and a particular data point "15" are disclosed, it is understood that values greater than, more than, less than, less than or equal to, and equal to 10 and 15, along with the range between 10 and 15, are disclosed. It is also understood that each unit between two particular units is also disclosed. For example, if 10 and 15 are disclosed, 11, 12, 13, and 14 are also disclosed.

[0154] While various example embodiments have been described above, various modifications may be made to any of the embodiments without departing from the scope of the disclosure as recited in the claims. For example, the order in which the various described method steps are performed may often be changed in alternative embodiments, and in other alternative embodiments, one or more of the method steps may be skipped altogether. Any features of the various device and system embodiments may be included in some embodiments and not included in other embodiments. Accordingly, the foregoing description has been provided primarily for exemplary purposes and should not be construed as limiting the scope of the disclosure as set forth in the claims.

[0155] The examples and figures included in this specification show, as examples and not by way of limitation, specific embodiments in which the subject matter may be practiced. As noted above, other embodiments may be utilized and derived therefrom, and thus structural and logical substitutions and changes may be made without departing from the scope of the disclosure. Such embodiments of the subject matter of the invention may be referred to individually or collectively by the term "invention" for the sake of convenience and without intending to limit the scope of the present application to any single invention or inventive concept, where in fact more than one is disclosed. Accordingly, while specific embodiments have been illustrated and described herein, any configuration calculated to achieve the same purpose may be used in place of the specific embodiments shown. The present disclosure is intended to cover any and all adaptations or variations of the various embodiments. Combinations of the above embodiments and other embodiments not specifically described herein will be apparent to those skilled in the art upon consideration of the above description.

Claims

1. In a handheld multi-unit dose dry powder inhaler device, a housing body having a swirling chamber therein, the swirling chamber being configured and arranged to allow a drug capsule to rotate with sufficient space within the swirling chamber, the housing body; at least one air inlet fluidly connecting the swirling chamber to an opening on an outer surface of the housing body; a mouthpiece coupled to the housing body and having an opening fluidly connected to the swirling chamber, the opening being configured such that a user can draw air through the opening, thereby drawing an air stream into the swirling chamber through the at least one air inlet, whereby the capsule can rotate and discharge its contents into the air stream and the contents can be delivered to the user's respiratory system through the mouthpiece opening, the mouthpiece; a rotatable downfall wheel having at least two capsule spaces each configured to hold a capsule, each of the capsule spaces having a central inclined portion located on the trailing side of the capsule space, the downfall wheel; a drive mechanism configured to repeatedly align the downfall wheel by a predetermined angular increment, such that each time the downfall wheel is aligned, one of the capsule spaces moves adjacent to the swirling chamber, the drive mechanism; a pair of lateral inclined portions adjacent to the swirling chamber and the downfall wheel, each of the central inclined portions being configured to cooperate to radially outwardly push a capsule from the capsule space into the swirling chamber, thereby enabling the device to automatically load multiple capsules one at a time into the swirling chamber, the pair of lateral inclined portions; A handheld multi-unit dose dry powder inhaler device comprising the above.

2. The device further comprises a rotatable carousel adjacent to the downfall wheel, the carousel being configured to rotate in a direction opposite to the rotation direction of the downfall wheel, the carousel having at least three capsule spaces each configured such that a capsule is pre-loaded therein, the carousel and the downfall wheel being configured to cooperate to transfer one capsule from the carousel to the downfall wheel each time the carousel and the downfall wheel are aligned together. The inhalation device according to claim 1.

3. Each time the carousel and the downfall wheel are aligned together, the downfall wheel rotates 90 degrees and the carousel rotates 22.5 degrees. The inhalation device according to claim 2.

4. The downfall wheel is provided with four capsule spaces, two of which are pre-loaded with capsules, and the carousel is pre-loaded with 28 capsules before first use. The inhalation device according to claim 2.

5. 30 capsules are loaded in the carousel, and then, before the first use, two of the 30 capsules are advanced from the carousel into the two capsule spaces of the downfall wheel. The inhalation device according to claim 4.

6. The device further comprises a piercing hub, to which at least one piercing pin is attached, the piercing hub being configured to rotate the at least one piercing pin into the capsule while the downfall wheel is aligned, thereby piercing the capsule while the capsule is moving. The inhalation device according to claim 1.

7. The piercing hub and the at least one piercing pin are configured to pierce the capsule perpendicular to the longitudinal axis of the capsule. The inhalation device according to claim 6.

8. The piercing hub and the at least one piercing pin are configured to pierce into the capsule at at least one of its hemispherical ends. The inhalation device according to claim 7.

9. The inhalation device according to claim 6, wherein the downfall wheel is configured to drive the piercing hub each time the downfall wheel is aligned.

10. The downfall wheel is configured to load a capsule into the swivel chamber through a lower end opening of the swivel chamber. A solid surface is provided on an outer periphery of the downfall wheel between respective ones of the capsule spaces. Each solid surface is configured to close the lower end opening of the swivel chamber during an alignment movement of the downfall wheel. The inhalation device according to claim 1.

11. The device further comprises a dose wheel that is aligned each time the downfall wheel is aligned. A series of numbers are located on the dose wheel. Each of the numbers represents a pre-loaded capsule in the device. The device further comprises a window configured to show one of the numbers indicating the number of capsules remaining in the device to a user of the device at a time. The inhalation device according to claim 1.

12. The inhalation device according to claim 11, wherein the series of numbers includes from 30 to 1.

13. The dose wheel further comprises a spiral groove configured to drive a window slidable radially with respect to the dose wheel. The series of numbers are arranged in a spiral pattern. The inhalation device according to claim 11.

14. The mouthpiece of the inhalation device according to claim 1 is configured to rotate between a closed position where a capsule can be captured in the swivel chamber and an open position where the capsule can be removed from the swivel chamber.

15. The inhalation device according to claim 14 further comprises a mouthpiece cover configured to rotate between a closed position covering at least a part of the mouthpiece and an open position exposing the mouthpiece.

16. The mouthpiece cover according to claim 15 is configured to align the downfall wheel when the mouthpiece rotates from the closed position to the open position.

17. The device further comprises a locking arm movable between a first position where it can hold the mouthpiece cover in the closed position and thereby prepare the device for the next cycle, and a second position where it cannot hold the mouthpiece cover in the closed position and does not activate the next cycle, the inhaler device according to claim 16.

18. The downfall wheel cam surface is configured to drive the locking arm from the first position to the second position when the mouthpiece cover is moved to its open position, and the mouthpiece comprises a tab configured to drive the locking arm from the second position to the first position when the mouthpiece is moved to its open position, the inhaler device according to claim 17.

19. In a method of operating a multi-unit dose dry powder inhaler device, providing an inhaler device having a swivel chamber, a mouthpiece, a mouthpiece cover, and a predetermined number of capsules pre-loaded within the inhaler device; rotating the mouthpiece cover from a closed position to an open position, thereby exposing the mouthpiece; automatically puncturing one of the pre-loaded capsules; automatically aligning the punctured capsule into the swivel chamber; drawing an air stream through the mouthpiece and rotating the capsule to discharge its dry powder contents into the air stream; A method comprising.

20. Automatically puncturing and automatically aligning are effected by rotation of the mouthpiece cover, the method according to claim 19.

21. The method according to claim 19, further comprising rotating the mouthpiece to open and discarding the capsule from the swivel chamber.

22. The method according to claim 21, further comprising rotating the mouthpiece to close and rotating the mouthpiece cover from the open position to the closed position, and the mouthpiece cover is automatically returned to the open position unless the step of rotating the mouthpiece to open is first performed.

23. The method according to claim 19, further comprising advancing a dose wheel when the mouthpiece cover rotates to the open position, the dose wheel indicating to a device user a number indicating how many capsules remain unused within the device.

24. The method according to claim 1, wherein the predetermined number of capsules pre-loaded in the inhalation device is at least 3, and each of the method steps except the step of preparing is performed at least 3 times.

25. The method according to claim 1, wherein the predetermined number of the capsules pre-loaded in the inhalation device is at least 30, and each of the method steps except the step of preparing is performed at least 30 times.

Images