Multi-unit dose dry powder inhaler and method of use

Abstract

The present disclosure provides a multi-unit dose dry powder inhaler device (50) provided with: a housing body having a swirl chamber therein; at least one air inlet (60); a suction nozzle (56); a rotatable drop wheel (82) having at least two capsule spaces each configured to hold a capsule; a drive mechanism (70, 74) configured to repeatedly index the drop wheel (82) at a predefined angular increment such that one of the capsule spaces moves adjacent to the swirl chamber each time the drop wheel is indexed; and a pair of side ramps (114, 115) adjacent to the swirl chamber and the drop wheel. The side ramps (114, 115) may be configured to cooperate with a central ramp (130) located in the capsule space to drive capsules radially outward from the capsule space and into the swirl chamber, thereby enabling the device to automatically load a plurality of capsules sequentially into the swirl chamber one at a time. The present disclosure also provides methods of use.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims the benefit of priority to U.S. Provisional Application No. 63 / 365,229, filed on May 24, 2022, and the U.S. Provisional Application is hereby incorporated by reference in its entirety.

[0003] Incorporated by Reference

[0004] All publications and patent applications mentioned in this specification are herein incorporated by reference to the same extent as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference for all intents and purposes. Technical Field

[0005] Embodiments of the present disclosure generally relate to inhaler devices. In particular, some implementations of the present disclosure relate to dry powder inhaler devices with multiple unit dose capabilities. Background Art

[0006] The present disclosure relates to inhaler devices, for example for inhaling dry powder medicines to treat asthma. Inhaler devices for inhaling the contents of capsules for medical use are known. However, from an operational point of view, available inhalers are not completely satisfactory and need to be improved.

[0007] U.S. Patent No. 7,284,552, issued to Mauro Citterio and entitled "INHALER DEVICE" and published on October 23, 2007, provides examples of prior art inhaler devices similar to those provided herein. The inhaler device comprises an inhaler body defining a recess for holding a medicament capsule of a substance to be inhaled, and a nose / mouthpiece communicated with the capsule recess. The device also comprises at least one perforating element coupled to the inhaler body and arranged to perforate the capsule to allow external airflow to mix with the capsule contents and be inhaled through the nose / mouthpiece.

[0008] Another example of a prior art inhaler device is provided by U.S. Patent No. 8,479,730 to Dominik Ziegler et al., entitled “INHALER DEVICE,” issued on July 9, 2013. The inhaler device of the 8,479,730 patent is similar in construction and operation to the inhaler device of the 7,284,552 patent, but has a mouthpiece pivotally attached to the edge of the inhaler body.

[0009] The above inhalers are single dose devices that require the user to perform many steps to administer each dose. What is needed and not provided by the prior art inhalers is a device that requires fewer steps and is easier to use. BRIEF DESCRIPTION OF THE DRAWINGS

[0010] The features and advantages of the present disclosure will be better understood by reference to the following detailed description which sets forth illustrative embodiments, in which the principles of the present disclosure are utilized, and the accompanying drawings, in which:

[0011] Figure 1 is an exploded perspective view of an exemplary embodiment of an inhaler device according to the present disclosure;

[0012] Figure 2 is a further perspective view of an exemplary inhaler device, the inhaler device being shown in its open state, i.e. in its capsule loading position;

[0013] Figure 3 is with Figure 2 a similar view, but showing an inhaler device according to the present disclosure during use thereof;

[0014] Figure 4 is a front elevational cross-sectional view of an inhaler device shown with a capsule disposed therein but in an unperforated state;

[0015] Figure 5 is with Figure 4 a similar view, but showing the inhaler device according to the present disclosure during a capsule perforation operation;

[0016] Figure 6 is a top view, partially in section, of an inhaler device according to the present disclosure;

[0017] Figure 7 is a perspective cutaway view of an inhaler device showing airflow through the device;

[0018] Figure 8 is a perspective view of an exemplary multiple unit dose dry powder inhaler device constructed in accordance with aspects of the present disclosure;

[0019] Fig. 9 yes Figure 8 A front side view of an inhaler device;

[0020] Fig.10 yes Figure 8 A rear side view of an inhaler device;

[0021] Fig.11 yes Figure 8 Left side view of the inhaler device;

[0022] Fig.12 yes Figure 8 A right side view of an inhaler device;

[0023] Fig.13 yes Figure 8A top view of an inhaler device;

[0024] Fig.14 yes Figure 8 A bottom view of an inhaler device;

[0025] Figure 15-1 to Figure 15-6 It is schematically shown Figure 8 A series of front and side views of the operating steps of the inhaler device;

[0026] Fig.16 yes Figure 8 An exploded view of an inhaler device;

[0027] Fig.17 yes Figure 8 a rear side cross-sectional view of an inhaler device;

[0028] Fig.18 yes Figure 8 A front perspective view of a chassis of an inhaler device;

[0029] Fig.19 yes Figure 8 A front side view of a chassis of an inhaler device;

[0030] Fig. 20 yes Figure 8 A rear side view of a chassis of an inhaler device;

[0031] Fig.21 yes Figure 8 A rear side view of a front chassis cover of an inhaler device;

[0032] Fig. 22 yes Figure 8 A front perspective view of a carousel of an inhaler device;

[0033] Fig.23 yes Figure 8 A rear perspective view of a turntable of an inhaler device;

[0034] Fig.24 yes Figure 8 A front perspective view of a downfall wheel of an inhaler device;

[0035] Fig.25 yes Figure 8 A rear perspective view of a drop wheel of an inhaler device;

[0036] Fig.26 yes Figure 8 A front side view of the internal components of the inhaler device;

[0037] FIG. 27A to FIG. 27O yes Figure 8A series of rear and side views of a chassis and internal components of an inhaler device;

[0038] Figure 27P is a side view showing a representative drug capsule after both hemispherical ends have been automatically pierced in accordance with aspects of the present disclosure; and

[0039] FIG. 28A to FIG. 46D yes Figure 8 Various views of the interlocking latch components of an inhaler device. DETAILED DESCRIPTION

[0040] With reference to the reference numerals of the above-mentioned drawings, an exemplary single-dose inhaler device 1 is described below. Figure 1 As best seen in the Figure, the exemplary inhaler device 1 comprises an inhaler mouthpiece 3 comprising a flange 4 having a pin 5 which is engageable in a corresponding hole 6 formed in the inhaler body 2. Although the term "mouthpiece" is used herein, it will be appreciated that in some embodiments this feature may function as a mouthpiece and / or a nasal nozzle.

[0041] The hole 6 is provided with longitudinal grooves (not shown) which are able to engage the intersecting teeth 8 of the pin 5 and with a bottom annular recess (not shown in detail) in which the teeth 8 are able to slide.

[0042] Thus, the pin 5 can be engaged in the hole by passing the tooth 8 through the slot 7 and, once bottomed out, can be fully rotated in its hole 6 , thereby also rotating the inhaler mouthpiece 3 relative to the inhaler body 2 .

[0043] The inhaler mouthpiece 3 can be locked in its closed state by means of a snap-on locking device, such as Figures 3 to 6 As shown, the snap-on type locking means comprises a hook portion 18 of the flange 4 having a small ridge (not shown) for engaging a corresponding ridge 20 formed in a latch recess 19 defined in the inhaler body 2 .

[0044] The inhaler body 2 is also provided with a recess for the capsule, which is open upwards and communicates with the outside through a perforated plate or grid 11 included in the inhaler mouthpiece 3 at the flange 4 and designed to separate the capsule recess 9 from a duct 12 of the mouthpiece.

[0045] Engageable in the recess 9 is a capsule 13 , which is of a type known per se and which is adapted to be perforated to allow easy access to the medicament contents held therein, the perforation being performed by any suitable perforation means.

[0046] In the disclosed embodiment, the perforating device comprises a pair of perforating needles 14, which can slide laterally under the reaction of an elastic element, which in this embodiment comprises a coil spring 15; each coil spring coaxially surrounds the perforating needle 14 and operates between a corresponding abutment element 16 and a hollow button element 17 that is rigid with the inhaler body 2. The perforating needle 14 can be similar to a hollow hypodermic needle and have a single-sided beveled tip to facilitate the perforation of the coating of the capsule 13 by the perforating needle 14. In other specific implementations, the perforating needle 14 can be solid and / or have other tip configurations.

[0047] The operation of the inhaler device according to the present disclosure is as follows. In the open state, Figure 2 As shown, the capsule is engaged in the capsule recess 9, and the mouthpiece 3 is snapped closed on the inhaler body 2. By pressing the button element 17, the piercing needle 14 will pierce the capsule 13, so that its content (usually fine powder) will communicate with the capsule recess. By applying suction to the mouthpiece 3 to generate an airflow, the airflow coming from the outside through the inlet 10 will enter the capsule recess and mix with the capsule contents. The tangential orientation of the inlet 10 relative to the capsule recess 9 causes the incoming air to generate a vortex airflow. The vortex airflow lifts the capsule 13 upward (by Figure 7 As shown by arrow A in the figure, the capsule bag 30 is left and enters the larger upper part of the capsule recess 9. As shown by arrow B, the vortex airflow further causes the capsule 13 to roughly surround the transverse axis of the capsule and roughly surround the longitudinal axis of the recess 9 (i.e., Figure 7 The capsule 13 is a substantially vertical axis in the capsule cavity) that rotates in the recess 9. However, because the diameter of the recess 9 is greater than the length of the capsule 13, the capsule can travel around the recess 9 as it rotates, rather than rotating around a single fixed axis. The centrifugal force from the rotating capsule 13 helps the contents of the capsule to leave the pierced end of the capsule, where it is atomized by the vortex airflow, passes through the nozzle grid 11 and the conduit 12, and is then inhaled by the user. In some embodiments, dry powder deagglomeration is achieved by: 1) shear force through the pierced hole in the capsule; 2) turbulence from the vortex airflow in the capsule cavity; and 3) particle collisions (with the walls of the device, with the nozzle grid, and with other particles).

[0048] Inhaler device 1 has very simple construction.Another advantage of inhaler device 1 is the specially designed configuration of perforating needle, and as described, this configuration can be similar to hypodermic needle.Because the pin of this type shows very little perforation resistance and very accurate operation, so can use the pin with larger diameter and do not damage capsule, thereby very simple perforation operation is provided.Use a small amount of perforating needles (in some embodiments, only have two) to allow to reduce the contact surface (perforation cross section is identical) between pin and capsule, as a result, reduce friction and affect the problem of existing inhaler.

[0049] refer to Figures 8 to 14 , another exemplary inhaler device 50 constructed according to aspects of the present disclosure is shown. Device 50 is a multiple unit dose dry powder inhaler. It includes a capsule recess or vortex chamber similar to the previously described inhaler device 1 in construction and operation. However, rather than requiring the user to manually insert a drug capsule at a time, a device 50 preloaded with multiple capsules is provided to the user, which are automatically loaded into the vortex chamber in sequence. In this exemplary embodiment, device 50 can be provided with up to 30 preloaded capsules. Because the inhaler device 50 can be used with separate capsules with standard sizes, rather than with medicines packaged in the compartments of blister strips, a variety of drug formulations can be provided for the device using standard capsule filling equipment, without the need for special blister packing filling equipment. Another advantage of capsules over blisters is that they can accommodate larger volumes of powder, which enables each inhalation to deliver a higher dose.

[0050] In this exemplary embodiment, the inhaler device 50 is generally pear-shaped or teardrop-shaped and has a body formed by a front cover 52 and a rear cover 54. The covers 52 and 54 can be assembled using fasteners, plastic snap features, adhesives, ultrasonic welding, and / or other suitable assembly methods. A mouthpiece 56 can be disposed above the capsule chamber portion 58. The mouthpiece 56 can be hingedly attached to the capsule chamber portion 58 so that the mouthpiece pivots about a horizontal pivot axis between a closed position (as shown) and an open position (see FIG. Figure 15-3 ) between the capsule compartment portion 58 (see Figure 15-4 ) to remove the empty drug capsule. Fig.18 ) may be formed in the capsule chamber portion 58, similar to Figure 4 The recess 9 shown in FIG. 1 is as previously described. In some embodiments, the height of the main portion of the vortex chamber / capsule recess 106 is less than 0.26 inches, or less than 12% higher than the diameter of the capsule it receives. This recess is shallower than prior art devices and is believed to reduce powder deposition and improve delivery efficiency. Air passage (see Fig.18 ) may be disposed on the opposite side of the recess in fluid communication with the vent 60 to provide an inlet for swirling the drug capsule within the recess, as previously described. In some embodiments, the vortex chamber / capsule recess 106 is not configured to enable the capsule to rotate, but rather merely directs one or more air streams over, around, and / or through the capsule.

[0051] A pivoting nozzle cover 62 may be disposed above the nozzle 56. In the exemplary embodiment, the nozzle cover 62 extends over the nozzle 56 and includes a pair of downwardly depending arms that extend over the top portions of the front cover 52 and the rear cover 54. The nozzle cover 62 pivots about a horizontal axis extending between its two arms and moves through approximately 90 degrees from a closed position (as shown) to an open position in which the nozzle 56 is exposed (see FIG. Figure 15-1 ). In other embodiments, the range of motion angles may be larger or smaller, depending on the function of the internal mechanism driven by opening and closing the nozzle cover. Figure 8 and Fig.12 As best seen in FIG. 1 , a recess 64 may be provided in the front cover 52 and the rear cover 54 to at least partially receive the nozzle cover 62 and provide a stop when the cover 62 is being opened. In this exemplary embodiment, the thickness of the device 50 across the front and rear covers is 30 mm, and the maximum thickness of the downwardly depending arm across the nozzle cover 62 is less than 35 mm. In this exemplary embodiment, the device 50 is less than 120 mm high and less than 65 mm wide at its widest point.

[0052] A dose counter aperture 66 may be provided in the front cover 52 for indicating to the user how many doses remain before the device 50 is exhausted, such as Figure 8 and Fig. 9 shown.

[0053] refer to Figure 15-1 to Figure 15-6 , schematically depicting a series of steps, illustrating the overall operation of the inhaler device 50. In this exemplary embodiment, the user first rotates the mouthpiece cover 62 from the closed position to the open position, such as Figure 15-1 As depicted, in the open position, the mouthpiece cover snaps into place. This action exposes the mouthpiece 56, pierces one of the medicament capsules preloaded into the device 50 and indexes it into the vortex chamber. This action also advances the dose counter wheel, causing the dose count shown by the dose counter hole to decrease by one.

[0054] After the mouthpiece cover 62 is rotated into the open position, the user places the mouthpiece 56 against their mouth and inhales the dry powder released from the swirling capsule, as Figure 15-2 As described and previously described. Then the user Figure 15-3 The depicted opening nozzle 56, as Figure 15-4 The depicted inverting device 50 is used to discard the empty drug capsule from the vortex chamber, and as Figure 15-5 The depicted closing nozzle 56. Finally, the user Figure 15-6The depicted closing of the mouthpiece cover 62 prepares the device 50 for repeating the above procedure when the next dose is to be inhaled. In some embodiments, the mouthpiece cover 62 cannot be moved to the closed position (or will not remain in the closed position) unless the mouthpiece 56 has first been opened and closed, as will be described in more detail subsequently.

[0055] refer to Fig.16 , an exploded perspective view shows the components of an exemplary inhaler device 50 (fasteners omitted for clarity). The device 50 includes (shown from left to right) a front cover 52, a sliding dose counter window 68, a dose counter wheel 70, a front chassis cover 72, a turntable 74, a chassis 76 having a capsule chamber portion 58, a mouthpiece 56, a mouthpiece cover 62, a hub spring 78, a piercing hub 80, a drop wheel 82, a latch arm 84, a rear cover 54, a mouthpiece cover spring 86, and a drive plate 88.

[0056] When the device 50 is assembled, the dial 74 is rotatably received in the forward-facing lower cavity 90 of the chassis 76. The dial 74 is attracted in the lower cavity 90 by the front chassis cover 72, which can be fixed to the chassis 76 by four fasteners (not shown) or any suitable means of registration and attachment. The central hub of the dial 74 extends through the central hole in the front chassis cover 72 in the forward direction so that the central hub can engage with the dose counter wheel 70. The dose counter wheel 70 can be attached to the dial 74 using a single fastener through its center or any suitable means of registration and attachment so that the dose counter wheel can rotate with the dial 74. A pair of forward-protruding pins or other registration features can be provided on the central hub of the dial 74 for engaging with mating recesses in the back side of the dose counter wheel 70 to ensure that the dose counter wheel remains correctly indexed with the dial 74. The sliding dose counter window 68 is received in a mating slot on the inside / back side of the front cover 52, which sandwiches the sliding window 68 between the cover 52 and the wheel 70. This arrangement allows the sliding window 68 to slide up and down, as will be described in more detail later. The front cover 52 can be fixed to the front side of the chassis 76 with a single fastener (not shown) and / or any other means suitable for registration and attachment.

[0057] The drop wheel 82 is configured to be rotatably received in the rearwardly facing upper cavity 92 of the chassis 76. The drop wheel is attracted in the upper cavity 92 by the rear cover 54, which may be secured to the back side of the chassis 76 by three fasteners (not shown) and / or any other means suitable for registration and attachment.

[0058] The piercing hub 80 may be provided with two piercing needles or sharps 94 configured to pierce the same side of the capsule at opposite hemispherical ends (perpendicular to the longitudinal axis of the capsule) of the drug capsule, rather than piercing the capsule through its ends along the longitudinal axis, as accomplished by the previously described device 1. When the device 50 is assembled, the piercing hub 80 resides in the central aperture of the drop wheel 82. The hub 80 has a forwardly extending shaft received in a mating aperture 96 in the upper cavity 92 of the chassis 76, and a rearwardly extending shaft received in a mating aperture 98 in the inside surface of the rear cover 54. With this arrangement, the piercing hub 80 is configured to pivot about a horizontal axis from front to back, thereby allowing the piercing needle to rotate between a lower position and an upper position, as will be described in more detail later. A torsion hub spring 78 may be provided between the hub 80 and the chassis 76 to bias the piercing needle 94 toward the lower position. In other embodiments (not shown), a four-bar mechanism may be used instead of rotating the piercing hub to move the piercing needle 94 into the capsule.

[0059] The latch arm 84 can be configured to slide up and down in a vertical channel formed between the back side of the chassis 76 and the inner side of the rear cover 54. The latch arm 84 is used to prevent the nozzle cover 62 from returning to or staying in its upper position covering the nozzle 56 until after the nozzle 56 has been opened and closed, as previously described. The details of the construction and operation of the latch arm 84 will be described later.

[0060] The drive plate 88 can be configured to reside in the matching recess 100 in the rear arm of the nozzle cover 62 so that the drive plate 88 rotates with the cover 62. The drive plate 88 includes a circumferentially extending deflection arm 102 and a tooth 85, which extends through the arcuate slot in the rear cover 54 to allow the nozzle cover 62 to drive the drop wheel 82 ninety degrees once, as will be described in detail later. The nozzle cover spring 86 can be arranged between the drive plate 88 and the rear cover 54 so that the nozzle cover 62 is biased towards its lower part / open state. In some embodiments, the feature of the drive plate 88 can be directly set in the nozzle cover 62, and the drive plate itself can be omitted.

[0061] The nozzle 56 may be provided with a hinge feature along its rear edge (not shown) for cooperating with the hinge feature 104 on the rear top edge of the chassis 76. This arrangement allows the nozzle 56 to pivot about a longitudinal horizontal axis between a closed position and an open position.

[0062] As shown, the rear cover 54 may be provided with an inwardly facing upper slope 115. The function of the slope 115 is described below. Fig.24 and Fig.25 are described in the discussion of .

[0063] refer to Fig.17, the overall capsule indexing sequence of the inhaler device 50 will be described. In this exemplary embodiment, the device 50 is configured to be preloaded with 30 medicament capsules. Fig.17 In the embodiment, capsules are numbered from 1 to 30, wherein number 1 is the first dose, and number 30 is the last dose. Capsules 1 and 2 are loaded into two spaces of four spaces positioned at intervals of 90 degrees around the circumference of the drop wheel 82. Capsules 3 to 17 are loaded into 15 spaces, which are positioned at intervals of 22.5 degrees, thereby forming an outer ring around the circumference of the turntable 74. Capsules 18 to 30 are loaded into 13 spaces, which are also positioned at intervals of 22.5 degrees, thereby forming an inner ring in the turntable 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 capsules can be loaded from the same side of the device (from the front side of the turntable in this exemplary embodiment). Then, the indexing mechanism is activated twice to index capsules 1 and 2 from the outer ring of the turntable to the drop wheel positions 1 and 2, so that the device is ready for use. This leaves two blank spaces in the inner ring, as shown in the figure. In other embodiments, the drop wheel may have space for fewer or more than 4 capsules. In some embodiments, the turntable may be omitted and a means is provided for the user to insert the capsule from the side of the device into the drop wheel to provide a single or multi-dose device with an automatic piercing solution.

[0064] During operation, the drop wheel 82 rotates counterclockwise (as viewed from the rear of the device 50) and the turntable 74 rotates clockwise. The drop wheel 82 indexes 90 degrees at a time, and the turntable 74 indexes 22.5 degrees at a time. Fig.16 ) of the inner side of the drive plate 88 ( Fig.16 ) drives the drop wheel 82 each time the cover 62 is moved 90 degrees from the closed position to the open position ( Fig.17), as will be described in more detail later. At each time the drop wheel 82 is indexed 90 degrees, it drives the turntable 22.5 degrees by a Geneva-type mechanism (not shown), as will also be described in more detail later. With this arrangement, when the nozzle cover 62 is opened, the capsule in the number 1 position is pierced and moved into the vortex chamber 106, and each remaining capsule is pushed into the position previously occupied by the previous capsule. In other words, the number 2 capsule stays in its cavity, but is pushed into the position previously occupied by the number 1 capsule, the number 3 capsule is pushed from the turntable 74 into the position previously occupied by the number 2 capsule of the drop wheel 82 (but in a different cavity), and so on. This means that the number 30 capsule eventually pushes through each position in the inner ring of the turntable 74, is moved into the outer ring of the turntable 74, is pushed through each position in the outer ring, is moved from the turntable 74 into the number 2 position of the drop wheel 82, and is pushed into the number 1 position before being loaded into the vortex chamber 106.

[0065] refer to Figures 18 to 20 , showing the details of the chassis 76. Fig.18 and Fig.19 As shown, the central hub of the lower cavity 90 is provided with a series of ratchet teeth 108 along its inner surface to prevent the turntable 74 (not shown) from rotating in the reverse direction. Fig.19 As best seen in FIG. 1 , the lower cavity 90 may be provided with an inner ramp 110 configured to be disposed as the drug capsule is being fed by the turntable 74 ( Fig.17 The lower cavity 90 may also be provided with an outer ramp 112, which is configured to guide the rearward end of the drug capsule from the outer ring of the bottom frame cavity 90 of the bottom frame 76 upward to the upper cavity 92 of the bottom frame 76 by the rotation of the turntable 74, and enter the drop wheel 82 ( Fig.17 As shown in Fig. 20 As shown, the upper cavity 92 may be provided with an upper ramp 114 configured to direct the forward end of the medicament capsule upward as the medicament capsule is being propelled from the drop wheel and into the vortex chamber 106 .

[0066] refer to Fig.21 , showing details of the front chassis cover 72. The cover 72 may be provided with an inner slope 116 (with Fig.19 The inner slope 110 shown in FIG. 1 corresponds to the inner slope 110 shown in FIG. 1 , which is configured to be disposed when the drug capsule is being rotated by the turntable 74 ( Fig.17 When the lid 72 is rotated and pushed forward, the forward end of the drug capsule is guided upward from the inner ring of the bottom frame cover 72 to the outer ring. The lid 72 can also be provided with an outer ramp 118 (with Fig.19The outer ramp 112 shown in FIG. 1 corresponds to the outer ramp 112 shown in FIG. 1 ), which is configured to guide the forward end of the drug capsule from the outer ring of the bottom frame cover 72 upward into the upper cavity 92 of the bottom frame 76 by the rotation of the turntable 74, and enter the drop wheel 82 ( Fig.17 .

[0067] refer to Fig. 22 and Fig.23 , showing details of the turntable 74. The outer circumference of the central hub 120 can be provided with triangular protrusions 122 between the capsule spaces. As shown, a central ramp 124 can be provided, which has a push or drive surface configured to work in cooperation with the triangular protrusions 122 and the side ramps described previously to move the capsule from the inner ring to the outer ring, and also from the outer ring to the upper cavity 92 / drop wheel 82. In this embodiment, the central ramp 124 has a width of approximately 40% of the length of the capsule, and the side ramps described previously each have a width of approximately 30% of the capsule. In some embodiments, the width of the side ramps is at least 27%, 28%, 29%, 30%, 31%, 32% or 33% of the length of the capsule. In other embodiments (not shown), the ramp positions can be exchanged by providing a stationary central ramp on the chassis and providing side ramps on the turntable and / or drop wheel. As Fig.23 As shown, one or more flexure arms 126 may be disposed on the inner side of the central hub 120. The flexure arms 126 may be configured to engage with the ratchet teeth 108 ( Fig.18 and Fig.19 ) work cooperatively to prevent the turntable 74 from rotating in the reverse direction.

[0068] refer to Fig.24 and Fig.25 , showing the details of the drop wheel 82. As previously described, the drop wheel 82 can be provided with four capsule spaces 128, only two of which are occupied at any one time. Each capsule space 128 can be provided with a central ramp 130 for working in cooperation with the previously described upper side ramps 114 and 115 to move each capsule from the upper cavity 92 / drop wheel 82 of the chassis 76 to the vortex chamber (not shown) in sequence. In this embodiment, space is left between the central ramp 130 and the side ramps so that the piercing needle 94 can pass between the central ramp and the side ramps. In this exemplary embodiment, the piercing needle 94 has a diameter of approximately 0.047 inches. The upper side ramps 114 and 115 (respectively at Fig. 20 and Fig.16114 and 115 are configured to engage the hemispherical end of the capsule, while the central ramp 130 is configured to engage the central cylindrical portion of the capsule. Therefore, the ramps 114 and 115 can be provided with a compound angle (i.e., angled relative to a vertical plane transverse to the back cover, and also angled relative to a horizontal plane). In some embodiments, the ramps 114 and 115 are angled at about 45 degrees relative to two of these planes. In some embodiments, the ramps 114 and 115 have an angle between 30 degrees and 60 degrees relative to two of these planes.

[0069] The drop wheel 82 may be provided with a solid surface 131 between the capsule spaces 128 for sealing the bottom of the vortex chamber for use once the capsules have been loaded into the chamber so that air does not enter the chamber from the bottom, or the airflow is at least reduced and any gaps can be controlled to systematically achieve the desired resistance. Fig.24 As best seen in FIG. 1 , the front edge of the drop wheel 82 may be provided with four forwardly projecting drive lugs 132 configured to engage with the dose counter wheel 70 ( FIG. 14 ) in a grooved wheel mechanism type manner. Fig.27A The drive lug 132 is engaged with the external teeth of the piercing hub 80 (shown in FIG. 1 ) so that each time the drop wheel indexes 90 degrees, the drive lug drives the dose counter wheel 70 and the attached rotating disk 74 through 22.5 degrees. In this exemplary embodiment, the drive lug 132 is also used to drive the piercing hub 80, as will be described in detail later. Fig.25 As best seen in FIG. 1 , the rearward edge of the drop wheel 82 may be provided with four radially outwardly extending ratchet teeth 134 configured to engage the flexure arms 102 ( Fig.16 ) cooperate to allow the drive plate 88 to drive the drop wheel 82 as previously described.

[0070] refer to Fig.26, details of the dose counting wheel 70 are shown. The dose counting wheel 70 can be provided with a series of numbers, each of which represents the number of remaining capsules / doses. In this exemplary embodiment, numbers 1 (or 0) to 30 are provided. In other embodiments (not shown), a larger or smaller number of doses can be represented. For example, 7, 14, 21, 28, 31, 35, 42, 45, 49, 56, 60, 61, 62, 63 or 70 doses (wherein the device is configured with space for at least that many doses) can be represented. In some embodiments, some capsule spaces in the drop wheel and / or the turntable remain unused, and there are no numbers associated with them on the dose counting wheel 70 (except 0). In some embodiments, the drop wheel can have only two capsule spaces spaced 180 degrees apart, wherein only one of the spaces is preloaded with capsules. In other embodiments, the drop wheel can have 3, 5 or more capsule spaces evenly spaced around its circumference. In the current exemplary embodiment, the number 30 down to zero is arranged as a spiral extending from the outer radius to the inner radius of the dose counting wheel 70 and covering 675 degrees, as shown. In other embodiments (not shown), the spiral can extend from the inner radius to the outer radius, and / or can extend a greater or lesser number of degrees.

[0071] As shown, a helically extending groove 136 may be provided on the front side of the dose counter wheel 70. A mating protrusion (not shown) may be provided on the sliding dose counter window 68 ( Fig.16 With this arrangement, the dose wheel 70 rotates counterclockwise (as shown in FIG. Fig.26 When the sliding window 68 is rotated through 675 degrees (as observed in FIG. 1 ), the dose wheel slowly drives the sliding window 68 vertically upward. This ensures that only one dose is passed through the hole 66 ( Fig.16 ) shows a number.

[0072] refer to Fig.26 and Fig.27A , showing details of the piercing hub 80. Fig.26 The piercing hub 80 is shown from the front, while Fig.27A It is shown enlarged and from the back. As previously indicated, the drop wheel drive lug 132 ( Fig.26 ) is used to rotate the hub 80 about the hub rotation axis 138. Each time the drop wheel 82 rotates 90 degrees clockwise (as shown in Fig.26 140 to drive the hub 80 about its own axis which is offset from the axis of rotation of the drop wheel through 77.29 degrees. In this embodiment, the rotation ratio between the drop wheel and the hub 80 is not linear. As the hub 80 rotates, a pair of piercing needles or sharps 94 (one forward and one rearward, so that Fig.26 and Fig.27AOnly one is seen in the figure) is driven into the capsule 142. The hub cam 140 can be shaped as shown to allow the piercing needle 94 to be driven into the capsule 142 after each capsule is dropped from position 1 ( Fig.17 142) tracks each capsule as it moves upward toward the vortex chamber 106, wherein the needle 94 continues to point roughly along the diameter of the capsule 142 as the capsule moves. Along with the rotation of the hub 80, the hub spring 78 is wound tighter. When the capsule 142 is pushed onto the previously described ramp by the rotation of the falling wheel 82, the capsule is driven to disengage the needle. This occurs before the hub 80 returns to its starting position. When the falling wheel 82 approaches the end of its 90 degree stroke, the tip of the cam arm 140 passes over the drive lug 132, thereby allowing the hub spring 78 to rotate the hub 80 back to its starting position as shown in the figure. Once the hub 80 returns to its starting position, the cam 140 is able to engage the next drive lug 132 and repeat the piercing process to the next capsule. The following further describes this automatic piercing sequence in detail.

[0073] refer to FIG. 27B to FIG. 27E , showing an enlarged view of the capsule piercing member and other internal components. In particular, Fig.27B The piercing hub 80, drop wheel 82 and associated components are shown. Fig.27C The drop wheel 82 is shown and its four capsule recesses and four drive lugs are labeled. Fig.27D The piercing hub 80 and its cam features and profile are shown. Fig.27E A portion of the dose counter wheel 70 is shown with its cam features and profile.

[0074] refer to FIG. 27F to FIG. 27O , the piercing hub 80 and the drop wheel 82 are shown in a state sequence as they undergo a piercing cycle. These views show the capsule indexing mechanism sequence, the automatic piercing mechanism sequence and the dose counter mechanism sequence of this exemplary embodiment.

[0075] from Fig.27F Initially, the automatic piercing mechanism is shown in its initial position, with capsule positions 1, 2, and 3 identified. As shown, the gap between the tip of the piercing needle 94 and the capsule in position 1 ensures that the needle does not contact the capsule before the capsule 2 is moved to the piercing position. In this initial position, the drive lug #4 is just beginning to contact the cam of the piercing hub 80, and the dial 74 and dose counter wheel 70 are in the "30" dose remaining position (not shown).

[0076] exist Figure 27G , the drop wheel 82 has rotated counterclockwise enough to cause the drive lug 132 to rotate the hub 80 counterclockwise until the piercing needle tip contacts the hemispherical end of the capsule 1.

[0077] Fig.27HFurther advancement of the drop wheel 82 is shown, so that the piercing needle 94 has entered the capsule 1. With further rotation of the drop wheel 82 and the needle hub 80, the insertion depth will continue to increase. The drive lug #3 is now contacting one of the cam surfaces of the dose wheel 70.

[0078] Fig.27I The point in the piercing cycle where the needle reaches its theoretical maximum insertion depth is shown. Capsule #1 is pushed against the inside surface of chassis 76 to maximize the needle insertion depth. Driven by drop wheel 82 bump #3, turntable 74 and dose counter wheel 70 continue to rotate clockwise. Capsule #3 begins to ramp up toward drop wheel capsule recess #3.

[0079] exist Fig.27J 1, capsule #1 contacts the bottom of the chassis ramp, which will help lift it into the vortex chamber 106. Driven by the drop wheel boss #3, the dose counter wheel 70 continues to rotate clockwise. The drop wheel boss #4 continues to rotate the hub 80 counterclockwise via the cam arm. The turntable 74 pushes capsule #3 up the lower ramp toward the drop wheel capsule recess #3.

[0080] exist Figure 27K , the drop wheel lug #4 is sliding along the outer cam profile of the hub 80 to hold the hub in the raised position as shown.

[0081] Figure 27L It shows that the drop wheel 82 has been Figure 27K 80 is further rotated counterclockwise, but the hub 80 remains in the same position. In this position, the drop wheel 82 has rotated to the end of its holding rotation phase (i.e., the lug #4 has reached the lower end of the outer cam profile of the hub 80). Additional rotation of the drop wheel 82 has driven capsule #1 up the upper ramp, off the needle 94 and somewhat into the vortex chamber 106.

[0082] Fig.27M The hub 80 is shown as the drop wheel lug #4 passes over the hub cam profile, after it has automatically returned to its initial rest position (driven by the torsion spring 78, Fig.26 After that.

[0083] Fig.27N The drop wheel 82 is shown to be further advanced and the dose counter wheel 70 has been indexed 22.5° clockwise from its starting position to the next position. Further counterclockwise rotation of the drop wheel 82 will cause the drive lug #3 to clear the upper end of the dose counter wheel cam profile.

[0084] exist Fig.27O, the automatically pierced capsule #1 has been delivered to the swirl chamber 106. The drop wheel 82 is now reset into the inhalation position with the drop wheel surface 131 closing off the bottom of the swirl chamber 106. The turntable 74 and dose counter wheel 70 are now in the "29" doses remaining position and the capsule indexing, automatic piercing and dose counting sequence is set to start again.

[0085] Figure 27P A representative drug capsule is shown after both hemispherical ends have been automatically pierced as described above.

[0086] refer to FIG. 28A to FIG. 46D , showing the construction and operation of the nozzle cover interlock latch. As previously referenced Fig.15 As mentioned, in this exemplary embodiment, after the user inhales a dose from the device 50, the mouthpiece cover 62 can be moved over the mouthpiece 56 to its closed position, but will not remain there without springing back to the open position unless the mouthpiece 56 has first been opened and closed. This signals to the user that the empty capsule remaining in the vortex chamber needs to be discarded before closing the device 50 and putting it away, so that the device is ready for its next inhalation cycle.

[0087] like Fig.43B and FIG. 46A to FIG. 46D As best seen in FIG. 1 , the latch arm 84 moves vertically between two states: an upper position 1 in which the nozzle cover can be closed, thereby preparing the device for its next cycle; and a lower position 2 in which the nozzle cover will not remain closed and the next cycle will not be initiated. FIG. 28A to FIG. 46D As shown, when the nozzle cover 62 is being opened, the latch arm 84 is driven downward from position 1 to position 2 by the lower drop wheel cam surface 146 (at Fig.35A and Fig.35B ), and when the nozzle 56 is being opened, it is the nozzle tab 144 (at Fig.44 and FIG. 46A to FIG. 46D best seen in FIG. 28A to FIG. 46D Further details are provided in .

[0088] In some embodiments (not shown), the inhaler device is not configured with the above-mentioned interlocking features, so that the mouthpiece cover can be opened and closed and another drug delivery cycle started regardless of whether the mouthpiece has been opened and closed first.

[0089] In exemplary embodiment disclosed herein, inhaler device 50 is configured to make the user hold this device and operate its all functions with one hand, or can hold this device with one hand and operate it with another hand.The commodity cost of device 50 makes it be recycled or otherwise disposed after all its capsules are exhausted.In some specific implementations, device 50 can be reloaded with new capsule and reused after it has been cleaned and / or sterilized.In some specific implementations, inhaler device can be configured to make empty rotating disk, cartridge or other capsule carrying device can be easily removed from inhaler device by end user or the supplier of inhaler device and replaced with full capsule carrying device.

[0090] Smart device components

[0091] In certain embodiments, "smart device" feature can be incorporated in the inhaler device 50. For example, device 50 can be configured to record time, date, position, remaining dose and / or user input whenever dosage cycle has begun and / or completed. Some or all of these data and / or additional data can be stored on the device for later retrieval, and perhaps can be transferred to another device, such as smart phone, tablet computer, laptop computer, desktop computer, computer network or other devices by wired or wireless mode. Data recording and / or transmission event can be triggered by: being opened or closed by the suction nozzle cover, being opened or closed by the suction nozzle, by the automatic sensing of the air flow through the suction nozzle, by the user input, by preset time and / or by one or more other triggers. These events can be referred to as the "delivery signature" triggered by the "deflection component" of starting "sensor component" (such as the cam surface of actuating microswitch). Each component in these components is further described in more detail now.

[0092] Sensor components

[0093] As described above, aspects of the present disclosure include systems and devices that include sensor components. The sensor components according to embodiments of the present disclosure are configured to obtain one or more data inputs from the subject systems and devices or from the immediate vicinity of the subject systems and devices, 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).

[0094] In some embodiments, the sensor component may include a sound sensor (eg, a microphone) or a pressure sensor to detect data related to inhalation quality (eg, peak flow rate, average flow rate, peak pressure, inhalation volume, inhalation duration, etc.).

[0095] In some embodiments, the sensor component includes a circuit board component that is configured or adapted to mechanically support and electrically connect one or more electronic components of the subject sensor. The circuit board component according to an embodiment of the present disclosure may include, but is not limited to, a printed circuit board, an etched circuit board, a flexible circuit board, or any combination thereof. In some embodiments, the circuit board component includes a printed circuit board (PCB).

[0096] A circuit board component according to an embodiment of the present disclosure may include conductive traces, pads, or other features etched from a conductive sheet (e.g., a copper sheet) attached to a non-conductive substrate. In some embodiments, standard circuit components such as, for example, capacitors, resistors, memory components, etc. are electrically connected to the circuit board component (e.g., soldered to a PCB). Connecting one or more electronic circuit components to a PCB produces a printed circuit assembly (PCA) or a printed circuit board assembly (PCBA), which terms are used interchangeably herein.

[0097] Aspects of the present disclosure include switches configured to make or break electrical contact in a subject circuit board component in response to an external stimulus (e.g., in response to an external mechanical stimulus). In some embodiments, the circuit board component includes a momentary contact switch configured to make or break electrical contact only when the momentary contact switch is in an activated state. In some embodiments, the circuit board component includes a non-momentary contact switch configured to make or break electrical contact until the non-momentary switch is activated again.

[0098] In some embodiments, the sensor component includes a position sensor that is configured or adapted to permit position measurement 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 actuation component and / or a deflection component. In some embodiments, the position sensor is configured to detect the orientation of one or more components of the subject device. The position sensor according to an embodiment of the present disclosure can be an absolute position sensor or a relative position sensor, and can be a linear, angular, or multi-axis position sensor. In some embodiments, the position sensor is configured to obtain multiple measurements within a defined time interval or during the execution of a drug delivery procedure so as to measure the position of one or more components of the subject system or device based on time or based on the progress through the drug delivery procedure.

[0099] In some embodiments, the sensor component and / or the deflection component includes a force sensor that is configured or adapted to detect and / or measure one or more forces in one or more components of the subject drug delivery system and device. The force sensor according to an embodiment of the present disclosure can be an absolute force sensor or a relative force sensor. Non-limiting examples of force sensors include resistive strain gauges, elastic strain gauges, foil strain gauges, semiconductor strain gauges, thin film strain gauges, wire strain gauges, piezoelectric force transducers, strain gauge dynamometers, inductive sensors, etc.

[0100] In some embodiments, the sensor component includes a light sensor that is 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 near the subject drug delivery system or device is above a predetermined threshold. 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.

[0101] In some embodiments, the sensor component includes a motion sensor that is configured or adapted to detect and / or measure the motion of the subject drug delivery system or device. For example, in some embodiments, the motion sensor is configured to determine whether the device or its components move beyond a predetermined threshold. The motion sensor according to an embodiment 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 motion of the subject device, thereby indicating that the user has begun to interact with the device.

[0102] In some embodiments, the sensor component includes a temperature sensor, which is configured or adapted to detect and / or measure the temperature of one or more components of the subject system or device. For example, in some embodiments, the temperature sensor is configured to determine whether the temperature of the medicine is higher than a predetermined threshold or within a predetermined temperature range. The temperature sensor according to an embodiment 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 subject device has been removed from cold storage and has reached a temperature suitable for administering medicine to a patient. In some embodiments, the temperature sensor is used to determine when the cold chain is broken (that is, when the temperature of the device or a part thereof is increased to a temperature higher than a predetermined threshold temperature), and to record the information. In some embodiments, the temperature sensor is used to track when the device or a part thereof is increased to a temperature higher than a predetermined threshold temperature, and to wake up the device to record the inhalation procedure when the temperature reaches a predetermined threshold temperature. Any information related to the cold chain of the device can be recorded and used for information tracking and / or preparing the device for use. In some embodiments, the device is configured to wake up from deep sleep, read the temperature from the sensor, and return to sleep. This process can be performed once a minute or at other frequencies at a low power level to allow long-term storage of the device. In some embodiments, due to the fast action of the microprocessor and the selective powering up of only the circuit components needed to read the temperature, this process can be carried out for up to 5 years on a single battery.

[0103] In some embodiments, the sensor component includes 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 includes one or more detection components (e.g., capacitive sensing components) that are placed adjacent to or on the inner side of the outer surface of the subject drug delivery system or device and are electrically connected to the touch sensor. When the user touches the detection component, an electrical signal is sent to the touch sensor, indicating that the user has touched the device. In some embodiments, the touch sensor is used to determine that the user has made physical contact with the subject device (e.g., a portion of the user's skin has made physical contact with the subject device), indicating that the user has begun to interact with the device.

[0104] Aspects of the subject sensor components include a power component that is configured or adapted to provide power to the sensor component. In some embodiments, the power component includes a battery. In some embodiments, the power component includes a rechargeable battery. In certain embodiments, such as, for example, when one or more components are disposable, the power component does not include a rechargeable battery. In some embodiments, the power component includes one or more standard wires that are configured to supply power to the sensor component by establishing electrical contact with an external power source (e.g., a standard power outlet). In some embodiments, the subject system or device includes an on or off switch or button that can be used to turn the power of the system or device on or off as needed.

[0105] In some embodiments, the sensor component includes a memory component configured or adapted to store one or more drug identification characteristics therein. The memory component according to an embodiment of the present disclosure may be a volatile memory component or a 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 (for example, 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 has been connected to the sensor component. In certain embodiments, the sensor component includes a data acquisition component configured to acquire one or more drug identification characteristics stored in the memory component from an external source (for example, from an external encoder, or from a memory component on a drug turntable or cartridge). In some embodiments, the memory component is configured to receive encoded information wirelessly (for example, the data acquisition component is configured to wirelessly acquire one or more drug identification characteristics). In some embodiments, the sensor component includes a near field communication (NFC) component and / or a radio frequency identification (RFID) component configured for data exchange.

[0106] Drug identification characteristics according to embodiments of the present disclosure broadly include any information related to the identity and / or biochemical characteristics of a drug (including, but not limited to, the name, concentration, dosage, dosage, serial number, batch number, universal unique identifier (UUID), expiration date, manufacturing date, manufacturing location, or any combination thereof). In some embodiments, the memory component may 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 may further include one or more drug delivery device identification characteristics (including, but not limited to, system or device name, type, model, serial number, batch number, manufacturing date, manufacturing location, UUID, or any combination thereof). In some embodiments, the memory component is configured to be programmed (e.g., during device manufacturing) using over-the-air transmission utilizing a universal unique identifier (UUID).

[0107] Aspects of the subject sensor component include a wireless transmitter module configured to wirelessly transmit data to a networked device (e.g., a data management component). In some embodiments, the networked device is a secure networked device. In some embodiments, the transmitted data may be encrypted. In some embodiments, the wireless transmitter module is configured to communicate with one or more networked devices using a wireless transmission component (e.g., a communication link utilizing, for example, infrared light, radio frequency, light or ultrasound, or any combination thereof). Networked 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 networked devices include mobile computing devices (e.g., smart phones, laptops) connected using, for example, Bluetooth, Bluetooth Low Energy (BLE), or Wi-Fi. 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 wave spectrum communication system, including but not limited to those systems that can be transmitted to a central hub and then enter a cloud-based computing / data transmission environment.

[0108] The sensor component according to an embodiment of the present disclosure is configured to transmit a report including a drug dose complete signal when the sensor component detects a delivery signature. In some embodiments, the drug dose complete signal includes an indication that the actuation component has completed a delivery stroke. In some embodiments, the data management component is configured to determine the volume of drug delivered to the patient by identifying a drug delivery system or device and determining the volume of drug administered in a single delivery stroke of the identified system or device. In some embodiments, the data management component is encoded with information related to, for example, the volume of drug administered in a single delivery cycle of a specified system or device.

[0109] In some embodiments, the subject sensor component is configured or adapted to determine one or more operating states of the drug delivery system or device. For example, in some embodiments, the sensor component is configured to determine a ready state, wherein the system or device is ready to administer a drug dose to a patient. In some embodiments, the sensor component is configured to determine a not ready state, wherein the system or device is not ready to administer a drug dose to a patient. In some embodiments, the sensor component is configured to determine a dose in progress state, wherein the system or device is actively administering a drug dose to a patient. In some embodiments, the subject system or device can be configured to administer a dose of a drug to a patient over a time frame ranging from about 1 second up 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 longer, 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 longer. In some embodiments, the subject system or device is configured to remain in a dose-in-progress operating state for a period of time equal to the time frame for administering a drug to a patient.

[0110] 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 reduced power mode and is not ready to administer a dose of medication to a patient. In some embodiments, the sensor component is configured to determine a low battery state in which the battery charge is below a predetermined level.

[0111] Determination of any state in state described herein can be completed by analyzing one or more inputs from one or more subject sensor components. For example, in some embodiments, when the temperature value from the temperature sensor falls within a predetermined range (that is, indicating that the medicine is in the desired temperature range for use) and the position sensor indication system or device is in the desired position or orientation for use (for example, the position of the actuating member is determined to be correct for applying medicine to the patient), the ready state can be determined. This arrangement can also be used to train the user's correct "inhalation posture" orientation. In certain embodiments, this can be completed in conjunction with the correct inhalation posture orientation shown on the graphical user interface of the user's mobile device.

[0112] In some embodiments, the sensor component can transmit the determined operating state as described above to another component of the system or device (e.g., to a data management component). In certain embodiments, the data management component can then indicate the operating state to the user (e.g., on a GUI), thereby transmitting the operating state to the user. In some embodiments, as further described herein, the subject systems and devices may include one or more indicator components that are configured to transmit the operating state of the system or device to the user (e.g., a "ready to inhale" operating state).

[0113] The sensor components according to embodiments of the present disclosure may be mounted in any suitable location on a subject system or device. For example, in some embodiments, the sensor components may be mounted in a housing positioned anywhere on a 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 separate units (e.g., two or more different PCBAs) electrically connected to each other, each of the two or more separate units being mounted in a suitable location on a subject drug delivery system or device.

[0114] Deflection components

[0115] Aspects of the present disclosure include one or more deflection components configured to generate a delivery signature when a delivery stroke has been completed. The subject drug delivery systems and devices are configured to transmit a report including a drug dose complete signal only when a delivery signature has been generated and detected.

[0116] Deflection components according to embodiments of the present disclosure can be positioned in any suitable location on a subject system or device such that the deflection component can interact with one or more components of the subject system and device during execution of a delivery cycle. In some embodiments, the deflection component is positioned along the length of the actuation component and is configured to be mechanically deflected by at least a portion of the system or device during a delivery cycle. In some embodiments, the deflection component includes a force sensor configured to measure one or more forces applied by a user to a portion of the subject system or device. In some embodiments, the deflection component includes one or more inductive sensor coils configured to move toward one or more detection targets in response to forces applied to one or more components of the subject system or device.

[0117] As described above, in some embodiments, the deflection member includes a force sensor. Force sensors according to embodiments of the present disclosure may be absolute force sensors or relative force sensors, and the details of such sensors are well known in the art.

[0118] In some embodiments, the deflection component includes one or more inductive sensor coils, which are configured to move toward the detection target in response to a force applied to a portion of the subject system and device during a delivery stroke. The inductive sensor coil according to an embodiment of the present disclosure is generally operated by generating an alternating electric field, which can detect conductive materials within a certain vicinity of the inductive sensor coil. Therefore, the inductive sensor coil according to an embodiment of the present disclosure is generally operated in combination with one or more detection targets including conductive materials (e.g., conductive metal materials). The configuration of the inductive sensor coil and its detection target can take any suitable arrangement. For example, in some embodiments, the first inductive sensor coil is disposed on 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 extension component, which is configured to move through a portion of the subject device during a delivery stroke and is configured to pass through one or more portions of the detection target during a delivery stroke.

[0119] The detection target according to an embodiment of the present disclosure can have any number of different geometric shapes. For example, in some embodiments, the detection target has a uniform geometry that does not change significantly according to the position in a given direction. Non-limiting examples of uniform geometry detection targets include geometric shapes (e.g., rings, bands, rectangles, and squares). In some embodiments, the uniform geometry detection target can be placed on the inner or outer surface of the subject device, and can be detected when the inductive sensor coil passes through the detection target and / or moves toward it. In certain embodiments, the detection target with uniform geometry is arranged above at least half of the surface of the subject system or device.

[0120] In some embodiments, the detection target has a repeating geometry, wherein two or more uniform geometry detection targets are arranged in a repeating manner in a given direction along the surface of the subject device. 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. As the inductive sensor coil passes over each uniform target, the progress of the delivery stroke can be determined.

[0121] In some embodiments, the detection target has a variable geometry, where one or more dimensions of the detection target change depending on the position in a given direction. For example, in some embodiments, the variable detection target includes a conductive material that starts with a minimum width at a first end of a device component and gradually increases in width along the length of the component to a final maximum width at the other end of the component. Any number of changes in the variable geometry can be introduced to generate a unique reading or signature that is obtained when the inductive sensor coil moves past the variable geometry detection target.

[0122] Delivery Signature

[0123] As described above, aspects of the present disclosure include detection of a delivery signature by a subject sensor and / or data management component. A delivery signature according to an embodiment may include any of a variety of data components. For example, in an embodiment where the deflection component includes multiple trigger switches, the delivery signature may include data related to: the order of deflection of the trigger switches, the deflection duration of each trigger switch, one or more time intervals corresponding to the time between the deflection of a first trigger switch and the deflection of a second trigger switch, or any combination thereof.

[0124] In an embodiment where the deflection member includes a first inductive sensor coil and a second inductive sensor coil and a first detection target and a second detection target, the delivery signature may include detection signals from the first inductive sensor coil and the second inductive sensor coil corresponding to detection of the first detection target and the second detection target. In such embodiments, where the second detection target includes a uniform geometry, the delivery signature may include detection of the uniform geometry of the second detection target by the second inductive sensor coil that may be positioned on an extension member of the deflection member. Furthermore, in such embodiments, where the second detection target includes a repeating geometry, the delivery signature may include detection of the repeating geometry by the second inductive sensor coil that may be positioned on an extension member of the deflection member. Additionally, in an embodiment where the detection target includes a variable geometry, the delivery signature may include detection signals from one or more attributes of the variable geometry, such as a proportional signal.

[0125] The delivery signature according to an embodiment of the present disclosure may have a characteristic shape indicative of an inhalation curve. Various aspects of the present disclosure relate to detecting all or a portion of a delivery signature in order to measure the progress of a delivery curve or the completion of a delivery curve. 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 with a reference signature, and if the delivery signature matches the reference signature within an acceptable tolerance level, a successful delivery curve is recorded. In some embodiments, the data management component is programmed with one or more algorithms that are adapted to apply a set of rules to determine whether the delivery signature fully complies with a predetermined reference signature.

[0126] In one embodiment, a delivery signature is generated when a plurality of trigger switches are deflected in a given direction for a specified period of time. For example, the data management component determines that the delivery signature meets the reference signature when all trigger switches in the trigger switch assembly are deflected for a specified period of time (e.g., 3 seconds or more, such as 4, 5, 6, 7, 8, 9, and 10 seconds or more).

[0127] Actuating components

[0128] Aspects of the present disclosure include an actuating member configured to move so that the capsule is distributed from the capsule space into the vortex chamber. The actuating member according to an embodiment of the present disclosure can generally be actuated by any suitable mechanism. In some embodiments, the actuating member is configured to be manually moved by a user. In some embodiments, the actuating member is configured to be automatically moved by one or more driver components (e.g., one or more mechanical, electrical or electromechanical controllers).

[0129] In some embodiments, the actuation component may include a controller coupled to one or more components or subcomponents of the subject system or device. The controller may be configured or adapted (e.g., programmed if the controller includes electrical or electromechanical components) to move the actuation component in response to a user input or activation signal.

[0130] In some embodiments, the actuation component may include one or more coupling components configured or adapted to mechanically connect the actuation component to one or more additional components of the subject system or device. Coupling components according to embodiments of the present disclosure broadly include threaded couplers, adhesive couplers, snap-fit ​​couplers, magnetic couplers, or any combination thereof.

[0131] Indicator parts

[0132] Various aspects of the present disclosure include an indicator component that is configured or adapted to communicate one or more operating states of a subject drug delivery system or device to a user. In use, a given operating state of a subject drug delivery system or device can be assigned a specific indicator signal, and the subject indicator component can be used to communicate the specific indicator signal to the user, 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 audible indicators, each of which is described in further detail herein.

[0133] Aspects of the present disclosure include visual indicator components that are configured or adapted to display visual signals about the operating status of a subject system or device to a user. In some embodiments, the visual indicator includes a light emitting component. The light emitting component according to an embodiment of the present disclosure includes, but is not limited to, a light emitting diode (LED) and an organic light emitting diode (OLED). In some embodiments, the visual indicator includes a light pipe (also referred to as a light tube). In some embodiments, the light pipe includes a hollow structure that is configured to contain light within the structure by utilizing a reflective lining. In some embodiments, the light pipe includes a transparent solid material that is configured to contain light within the material by utilizing total internal reflection. In some embodiments, the visual indicator includes a diffuser component (e.g., a light pipe diffuser) that is configured to evenly distribute visual signals (e.g., light from an LED) over a defined area. In some embodiments, the visual indicator component includes a light pipe and a light pipe diffuser. The visual indicator component according to an embodiment 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, the operating state of the subject system or device can be assigned a specific color. For example, in one embodiment, the unready operating state is assigned a red color, and when the system or device is in an unready state, a visual indicator component is used to display the red color to the user. In some embodiments, the visual indicator component can be configured to flash the visual indicator on and off or remain constantly open to provide an indication of the operating state in a specific sequence (e.g., a series of three short flashes) 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 flashing yellow or blue indicator light), and being connected to a data management component (e.g., a flashing or constantly lit green or blue indicator light). Any of a variety of "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 trying 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 has been connected to a wireless network or a data management component. In some embodiments, the indicator component can be located on the GUI of the mobile device.

[0134] Aspects of the present disclosure include a tactile indicator component that is configured or adapted to generate one or more vibration signals specific to the operating state of the subject system or device. 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 with any desired combination of amplitude, frequency, and duration so as to generate multiple unique vibration signals. For example, in one embodiment, a vibration signal consisting of a single high-amplitude vibration of one second duration can be assigned to the not ready operating state.

[0135] Aspects of the present disclosure include an auditory indicator component that is configured or adapted to generate one or more auditory signals specific to the operating state of the subject system or device. 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 with a plurality of different tones and / or volumes. For example, in one embodiment, the not ready operating state can be assigned a sound consisting of a single high volume buzzer sound.

[0136] Indicator components according to embodiments of the present disclosure may be mounted in any suitable location on a subject system or device. For example, in some embodiments, the indicator component may be mounted in a housing positioned anywhere on a system or device. In some embodiments, the indicator component may include multiple separate components that work together to generate a desired indicator signal. For example, in one embodiment, a visual indicator component includes an LED that generates a visible light signal, and also includes a light pipe that transfers the visible light from the LED to one or more locations on the subject system or device. In some embodiments, the visual indicator further includes a light pipe diffuser that evenly distributes the visible light signal at a desired location (e.g., across the entire indicator window).

[0137] Housing parts

[0138] Aspects of the present disclosure include one or more housing components formed of a suitable material, such as, for example, ceramic, plastic, metal, or any combination thereof. In some embodiments, one or more individual components of a subject drug delivery system or device may be located within a single housing and formed as a single unit. In some embodiments, one or more components of a subject system or device may be located in a first housing component, and one or more additional components of the subject system or device may be located in a second housing component, and the first housing component and the second housing component may be operably coupled to each other to form a single unit.

[0139] In some embodiments, the housing includes one or more transparent or translucent windows made of a material that is at least partially light-transmissive and configured to allow ambient light to pass through the housing to a light sensor positioned therein. 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.

[0140] Data management components

[0141] Aspects of the present disclosure include a data management component that is configured or adapted to communicate with a subject system or device and / or a user, for example, to receive a report including a drug dose completion signal from a subject system or device, to send one or more commands to a subject system or device, or to send a reminder to a user that a drug dose should be administered at a certain time. In some embodiments, the data management component includes a computer (e.g., a personal computer, a networked computer, or a network server). In some embodiments, the data management device includes a mobile computing device (e.g., a smart phone 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 includes an application that is configured to manage one or more aspects related to administering drugs to a user (e.g., recording the administration of a separate drug dose to a patient, reminding a patient about an upcoming drug dose administration, 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 a user that one or more communication components are operable and / or have been connected to one or more additional components of a subject 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 (e.g., via Bluetooth or Wi-Fi connection) to the subject drug delivery system or device. In some embodiments, as described above, one or more indicator components on the subject drug delivery system or device can be further used to indicate to the user that the data management component is connected to the system or device. Any suitable combination of indicator components on the data management component and / or other components of the system or device can be used to indicate to the user the connection status of the data management component (e.g., connected, attempting to connect, not connected, disconnected, etc.).

[0142] In some embodiments, the data management component is configured or adapted to receive reports from the subject drug delivery system or device, and record one or more aspects of the report for the purpose of maintaining the patient's medical record / history. For example, in some embodiments, the data management component is configured to receive a report indicating that a drug dose is administered to a patient from a system or device, and the data management component records the administration of the drug dose, including the date and time of the delivery of the drug dose. In some embodiments, the report may include additional information related to, for example, the drug administered or the patient receiving the drug. In some embodiments, the report may include information related to one or more operating states of the subject system or device. For example, in some embodiments, the report includes information related to, for example, the temperature or temperature history of the system or device. In some embodiments, the report includes information related to the geographic location of the drug delivery system at the time of administration.

[0143] In some embodiments, the data management component is configured or adapted to receive one or more data inputs from a subject system or device and to 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 a drug identification characteristic from a subject system or device and to verify that the drug identification characteristic is valid before proceeding with the administration of the drug to the patient. In some embodiments, the data management component is configured to transmit the one or more drug identification characteristics to a remote database via the Internet and to receive an authentication signal in response before administering the drug to the patient.

[0144] In some embodiments, the data management component is configured or adapted to receive one or more data inputs from the subject system or device, and analyze the received data to determine whether a delivery stroke has been completed. For example, in some embodiments, the subject system or device is configured or adapted to transmit data from the deflection component and / or the sensor to the data management component, and analyze the received data and compare the received data to one or more stored delivery signature parameters (e.g., a reference delivery signature) to determine whether the received data corresponds to a delivery signature for the device.

[0145] In some embodiments, the data management component is configured or adapted to determine whether a particular drug delivery system or device or its components are the result of an authorized sale from a manufacturer and / or an authorized prescription for a drug from a prescribing healthcare provider (e.g., from a prescribing physician) in a particular geographic 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 subject drug delivery system or device (or its components, e.g., a drug turntable 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 also transmit the geographic location of the drug delivery system or device to a remote database. In some embodiments, the remote database is configured or adapted to compare one or more drug identification characteristics with the geographic location received from the data management component to determine whether a particular drug delivery system or device or its components (e.g., a drug capsule turntable or cartridge) is being used in the geographic location (e.g., a particular country) where it is sold.

[0146] In some embodiments, the data management component is configured to verify one or more operating states of the subject 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 that falls 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 whether the subject system or device is in a "ready" operating state prior to administering the drug to the patient.

[0147] The data management component according to an embodiment of the present disclosure is configured to determine the date and time (e.g., a timestamp for the administration of a drug dose) at which a drug is administered to a patient. In some embodiments, the data management component is configured to receive a drug dose completion signal from a subject system or device, and is configured to determine the exact time of drug administration based on additional information transmitted from the system or device. For example, in some cases, the subject system or device may not be operably connected to the data management component at a specific date and time at which drug administration is performed. In such cases, the subject system or device is configured to determine the time elapsed 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 and the time elapsed since administration are transmitted to the data management component. The data management component then uses the transmitted information to reversely calculate the specific date and time of completing the drug administration procedure, and records the information in the patient's record.

[0148] Controller, processor and computer readable medium

[0149] In some embodiments, the subject system or device may include a controller, a processor, and a computer-readable medium configured or adapted to control or operate one or more components of the subject system or device. In some embodiments, the system or device includes a controller that communicates with one or more components of the subject system or device and is configured to control various aspects of the system or device and / or perform one or more operations or functions of the subject system or device. In some embodiments, the system or device includes a processor and a computer-readable medium, which may 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 may be executed by a processor to provide some or all of the functionality described herein.

[0150] In some embodiments, the subject system or device includes a user interface, such as a graphical user interface (GUI), which is 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 a user.

[0151] Energy harvesting

[0152] Various aspects of the present disclosure include an energy harvesting system coupled to a drug delivery device as disclosed herein. The use of an energy harvesting system allows the drug delivery device to harvest energy from its surrounding environment in order to power onboard communication electronics. This reduces or eliminates the need for batteries positioned on the device. This in turn reduces the challenges associated with environmentally friendly disposal of the devices, which are typically disposable type devices. In some embodiments, mechanical energy is stored in a spring or similar device, and the energy is recaptured at the time of use (such as at the end of an inhalation or drug delivery cycle). In some embodiments, a spring or other storage mechanism supplies mechanical energy to a generator, which is converted to electrical energy, rectified and regulated to power wireless transmission from the drug delivery device to a mobile device or a home receiver or hub. As previously described, such wireless transmission can provide confirmation of drug delivery dose completion via smart device technology.

[0153] A variety of connection methods can be used to wirelessly connect a self-powered drug delivery device to a user's smartphone. These methods can be divided into direct methods and indirect methods:

[0154] Direct method - communication without external peripherals

[0155] BLE——Master / Slave

[0156] □ BLE - Unconnectable connection (advertising)

[0157] □BLE——Scan Response

[0158] □ WiFi

[0159] □NFC (Near Field Communication)

[0160] □ Cellular (Existing Logistics)

[0161] □Audio (using ultrasonic identifier)

[0162] Indirect methods – communications that require external peripherals / infrastructure

[0163] □Internet (web hosting)

[0164] □ “Home Hub” – RF (local)

[0165] □ “Home Hub” – Backscatter

[0166] □ “Remote Hub” – LORAWAN, SIGFOX, Narrowband Internet of Things (IoT)

[0167] In some embodiments of energy harvesting, BLE (Bluetooth Low Energy) can be selected as "non-connectable" because it is a widespread and mature technology. With 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 1.04mJ needs to be delivered to the BLE module for the type of communication described herein. Due to energy losses between the power generation device and the BLE module, in some embodiments, it is desirable to have a generator output of approximately 10mJ.

[0168] According to aspects of the present disclosure, an energy harvesting source may include:

[0169] □Environmental radiation

[0170] □Fluid flow

[0171] □ Photovoltaic

[0172] □Piezoelectric

[0173] □Pyroelectric

[0174] □Thermoelectric

[0175] □Static electricity

[0176] □Magnetic induction

[0177] □Chemistry

[0178] In the magnetic induction category, the energy harvesting source can be one of the following design configurations:

[0179] □Pulse Energy Harvester

[0180] □Magnetic levitation collector

[0181] □Cantilever beam collector

[0182] □Axial flux generator

[0183] □ Claw-pole micro generator

[0184] Further details of the above-described “smart device” features may be found in co-pending published U.S. applications 2019 / 0321555 and 2021 / 0046247, which are incorporated herein by reference.

[0185] When a feature or element is referred to as being "on" another feature or element in this article, it can be directly on another feature or element, or there can also be intermediate features and / or elements. On the contrary, when a feature or element is referred to as being "directly on" another feature or element, there are no intermediate features or elements. It will also be understood that when a feature or element is referred to as being "connected", "attached" or "coupled" to another feature or element, it can be directly connected, attached or coupled to another feature or element, or there can be intermediate features or elements. On the contrary, when a feature or element is referred to as being "directly connected", "directly attached" or "directly coupled" to another feature or element, there are no intermediate features or elements. Although described or shown for one embodiment, the features and elements described or shown in this way can be applied to other embodiments. Those skilled in the art will also recognize that the structure or feature mentioned to be arranged "near" another feature can have a part overlapping or located below an adjacent feature.

[0186] The terms used herein are only used for the purpose of describing specific embodiments and are not intended to limit the present invention. For example, as used herein, the singular forms "a", "a kind of" and "the" are also intended to include plural forms, unless the context clearly indicates otherwise. It will also be further understood that when the terms "include" and / or "comprise" are used in this specification, they specify the presence of specified features, steps, operations, elements and / or components, but do not exclude the presence or addition of one or more other features, steps, operations, elements, components and / or their groups. 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 " / ".

[0187] For ease of description, spatially relative terms such as "below", "below", "below", "above", "above", etc. may be used herein to describe the relationship between an element or feature and another element or feature, as shown in the accompanying drawings. It should be understood that, in addition to the orientations depicted in the accompanying drawings, spatially relative terms are also intended to cover different orientations of the device in use or operation. For example, if the device in the accompanying drawings is inverted, the elements described as "below" or "below" other elements or features will then be oriented to be "above" other elements or features. Therefore, the exemplary term "below" can cover the two orientations of "above" and "below". The device can be oriented in other ways (rotated 90 degrees or in other orientations), and the spatially relative descriptors used in this article are interpreted accordingly. Similarly, unless otherwise specifically noted, terms such as "upward", "downward", "vertical", "horizontal" are used herein only for the purpose of explanation.

[0188] Although the terms "first" and "second" may be used herein to describe various features / elements (including steps), these features / elements should not be limited by these terms unless the context otherwise indicates. These terms may be used to distinguish one feature / element from another feature / element. Therefore, without departing from the teachings of the present disclosure, the first feature / element discussed below may be referred to as the second feature / element, and similarly, the second feature / element discussed below may be referred to as the first feature / element.

[0189] Throughout this specification and the claims that follow, unless the context requires otherwise, the word "comprise" and variations such as "comprising" and "containing" mean that various components can be employed together in methods and articles (e.g., compositions and devices including apparatus and methods). For example, the term "comprising" will be understood to imply the inclusion of any specified elements or steps, but not the exclusion of any other elements or steps.

[0190] As used herein in the specification and claims, including as used in the examples, and unless otherwise expressly specified, all numbers can be interpreted as if preceded by the word "about" or "approximately", even if the term does not appear explicitly. When describing amplitude and / or position, the expression "about", "approximately" or "roughly" can be used to indicate that the value and / or position described are within the reasonable expected range of value and / or position. For example, a numerical value can have a value of + / -0.1% of a specified value (or range of values), + / -1% of a specified value (or range of values), + / -2% of a specified value (or range of values), + / -5% of a specified value (or range of values), + / -10% of a specified value (or range of values), etc. Unless the context indicates otherwise, any numerical value given herein should also be understood to include about or approximately that value. 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 contained therein. It should also be understood that when a value is disclosed, "less than or equal to" the value, "greater than or equal to the value," and possible ranges between values ​​are also disclosed, as appropriately understood by those skilled in the art. For example, if a value "X" is disclosed, "less than or equal to X" and "greater than or equal to X" are also disclosed (e.g., where X is a numerical value). It should also be understood that throughout this application, data is provided in a variety of different formats, and that the data represents endpoints and starting points and ranges for any combination of data points. For example, if a specific data point "10" and a specific data point "15" are disclosed, it should be understood that values ​​greater than, greater than or equal to, less than, less than or equal to, equal to 10 and 15, and between 10 and 15 are considered disclosed. It should also be understood that every unit between two specific units is also disclosed. For example, if 10 and 15 are disclosed, 11, 12, 13, and 14 are also disclosed.

[0191] Although various illustrative embodiments are described above, any of a number of changes may be made to the various embodiments without departing from the scope of the present disclosure as described in the claims. For example, in alternative embodiments, the order in which the various method steps described are performed may often be changed, while in other alternative embodiments, one or more method steps may be skipped entirely. In some embodiments, optional features of various device and system embodiments may be included, while in other embodiments, they may not be included. Therefore, the foregoing description is provided primarily for exemplary purposes and should not be construed as limiting the scope of the present disclosure set forth in the claims.

[0192] The examples and illustrations included herein show, by way of illustration and not limitation, specific embodiments in which this theme can be practiced. As mentioned, other embodiments can be utilized and derived therefrom, so that structural and logical substitutions and changes can be made without departing from the scope of this disclosure. These embodiments of the subject matter of the present invention may be referred to herein individually or collectively by the term "the present invention", which is merely for convenience, and is not intended to actively limit the scope of the present application to any single inventive concept when more than one inventive concept is actually disclosed. Therefore, although specific embodiments have been shown and described herein, any arrangement calculated to achieve the same purpose may replace the specific embodiments shown. The present disclosure is intended to cover any and all modifications or variations of various embodiments. After reviewing the above description, the combination of the above embodiments and other embodiments not explicitly described herein will be apparent to those skilled in the art.

Claims

1. A handheld multiple unit dose dry powder inhaler device comprising: a housing body having a vortex chamber therein, the vortex chamber being configured and arranged to allow the drug capsule to have sufficient space to rotate within the vortex chamber; at least one air inlet fluidly connecting the vortex chamber to an aperture on an outer surface of the housing body; a mouthpiece coupled to the housing body and having an opening fluidly connected to the vortex chamber, the opening being configured to allow a user to inhale air through the opening, thereby allowing an airflow to be inhaled through the at least one air inlet into the vortex chamber, the airflow in the vortex chamber enabling the capsule to rotate and eject the contents of the capsule into the airflow and through the mouthpiece opening to deliver the contents into the respiratory system of the user; a rotatable drop wheel having at least two capsule spaces each configured to hold a capsule, each of the capsule spaces having a central slope located on a lagging side of the capsule space; a drive mechanism configured to repeatedly index the drop wheel at predefined angular increments such that one of the capsule spaces moves adjacent to the vortex chamber each time the drop wheel is indexed; and a pair of side ramps adjacent the vortex chamber and the drop wheel, the side ramps being configured to cooperate with each of the central ramps to drive a capsule radially outward from the capsule space and into the vortex chamber, thereby enabling the device to automatically load a plurality of capsules into the vortex chamber one at a time in sequence.

2. An inhaler device according to claim 1, wherein the device further comprises a rotatable turntable adjacent to the drop wheel, the turntable being configured to rotate in a direction opposite to that of the drop wheel, the turntable having at least three capsule spaces each configured to be preloaded with a capsule, the turntable and the drop wheel being configured to cooperate to transfer one capsule from the turntable to the drop wheel each time the turntable and the drop wheel are indexed together.

3. An inhaler device according to claim 2, wherein each time the drop wheel and the turntable are indexed together, the drop wheel rotates 90 degrees and the turntable rotates 22.5 degrees.

4. The inhaler device according to claim 2, wherein the drop wheel is provided with four capsule spaces, two of which are preloaded with capsules, and the turntable is preloaded with 28 capsules before first use.

5. An inhaler device according to claim 4, wherein 30 capsules have been loaded into the carousel and then two capsules of the 30 capsules are pushed from the carousel into the two capsule spaces of the drop wheel before the first use.

6. The inhaler device of claim 1 , wherein the device further comprises a piercing hub provided with at least one piercing needle attached thereto, the piercing hub being configured to rotate the at least one piercing needle into the capsule while the drop wheel is being indexed, thereby piercing the capsule while the capsule is moving.

7. An inhaler device according to claim 6, wherein the piercing hub and the at least one piercing needle are configured to pierce the capsule perpendicular to a longitudinal axis of the capsule.

8. An inhaler device according to claim 7, wherein the piercing hub and the at least one piercing needle are configured to pierce into the capsule at at least one of the hemispherical ends of the capsule.

9. An inhaler device according to claim 6, wherein the drop wheel is configured to drive the piercing hub each time the drop wheel is indexed.

10. An inhaler device according to claim 1, wherein the drop wheel is configured to load capsules into the vortex chamber through a bottom opening of the vortex chamber, and wherein the drop wheel is provided with a solid surface on its outer circumference between each of the capsule spaces, each solid surface being configured to close the bottom opening of the vortex chamber between indexing movements of the drop wheel.

11. The inhaler device of claim 1 , wherein the device further comprises a dose wheel that is indexed each time the drop wheel is indexed, the dose wheel having a series of numbers thereon, each of the numbers representing a capsule preloaded into the device, the device further comprising a window configured to show a user of the device one of the numbers at a time indicating how many capsules remain in the device.

12. An inhaler device according to claim 11, wherein the series of numbers comprises 30 to 1.

13. The inhaler device of claim 11, wherein the dose wheel further comprises a spiral groove configured to drive a slidable window in a radial direction relative to the dose wheel, and wherein the series of numbers are arranged in a spiral pattern.

14. An inhaler device according to claim 1, wherein the suction nozzle is configured to pivot between a closed position in which the suction nozzle can draw a capsule into the vortex chamber and an open position in which the suction nozzle allows a capsule to be removed from the vortex chamber.

15. An inhaler device according to claim 14, wherein the device further comprises a mouthpiece cover configured to pivot between a closed position in which the mouthpiece cover covers at least a portion of the mouthpiece and an open position in which the mouthpiece cover exposes the mouthpiece.

16. An inhaler device according to claim 15, wherein the mouthpiece cover is configured to index the drop wheel when the mouthpiece is pivoted from the closed position to the open position.

17. An inhaler device according to claim 16, wherein the device further comprises a latch arm, the latch arm being movable between a first position in which the mouthpiece cover can be retained in the closed position, thereby preparing the device for its next cycle, and a second position in which the mouthpiece cover cannot be retained in the closed position and will not initiate the next cycle.

18. An inhaler device according to claim 17, wherein a drop wheel cam surface is configured to drive the latch arm from the first position to the second position when the mouthpiece cover is moved to its open position, and wherein the mouthpiece includes a tab configured to drive the latch arm from the second position to the first position when the mouthpiece is moved to its open position.

19. A method of operating a multiple unit dose dry powder inhaler device, the method comprising the steps of: providing an inhaler device having a swirl chamber, a mouthpiece, a mouthpiece cover, and a predetermined number of capsules preloaded into the inhaler device; pivoting the nozzle cover from a closed position to an open position to expose the nozzle; automatically piercing one of the preloaded capsules; automatically indexing the pierced capsule into the vortex chamber; as well as An air stream is drawn in through the mouthpiece, causing the capsule to rotate and release its dry powder content into the air stream.

20. The method of claim 19, wherein automatic piercing and automatic indexing are driven by pivoting of the nozzle cover.

21. The method of claim 19, further comprising pivoting the nozzle open and discarding the capsule from the vortex chamber.

22. The method of claim 21 , further comprising pivoting the nozzle closed and pivoting the nozzle cover from the open position to the closed position, wherein the nozzle cover automatically returns to the open position unless the step of pivoting the nozzle open has first been performed.

23. The method of claim 19, further comprising advancing a dose wheel when the mouthpiece cover is pivoted to the open position, the dose wheel showing a device user a number indicating how many unused capsules remain in the device.

24. The method of claim 19, wherein the predetermined number of capsules preloaded into the inhaler device is at least three, and each of the method steps, except the providing step, is performed at least three times.

25. The method of claim 19, wherein the predetermined number of capsules preloaded into the inhaler device is at least thirty, and each of the method steps, except the providing step, is performed at least thirty times.

Images