Portable holding chamber

Abstract

To provide a holding chamber, and in particular, a portable valved holding chamber that encloses and carries an associated pressurized metered dose inhaler.SOLUTION: The invention provides a medication delivery system including a holding chamber capable of delivering a single dosage of medicament multiple times from a metered dose inhaler. The holding chamber has a first housing component with a user interface with an outlet opening, and a second housing component with an inlet opening positioned at a distance from the outlet opening of the first housing component. The first housing component is pivotally connected to the second housing component about a pivot axis.SELECTED DRAWING: Figure 4

Description

[Technical field]

[0001] This application relates to holding chambers, and in particular to portable valved holding chambers (VHCs) for housing and carrying an associated pressurized metered dose inhaler (MDI). [Background technology]

[0002] VHC and MDI systems are typically used to treat conditions such as asthma, COPD, and cystic fibrosis. Using an MDI alone may not maximize or provide effective relief during an asthma exacerbation, and patients may not be confident that the MDI, especially rescue inhalers, is always working. Although the combined use of a VHC and an MDI improves the effectiveness of the MDI, users often do not carry the VHC due to the size of most commercially available VHCs. At the same time, the volume and / or length of the VHC correlates with the aerosol output of the VHC, which means that the VHC form must remain suitable for proper dosing.

[0003] In addition, many commercially available VHCs are stored separately from the MDI, requiring the user to carry and keep track of two delivery devices, which may not be easy during, for example, an asthma attack. Locating the MDI and VHC may be even more difficult at night or in low light conditions, especially in situations where the MDI or VHC is placed in a bag. Prescription of VHCs by health care providers and compliance by patients are likely to increase with the convenience of a relatively small and portable VHC, especially if the VHC allows the MDI to be stored between uses. Summary of the Invention

[0004] In one aspect, an embodiment of a holding chamber includes a first housing component with a user interface having an outlet opening and a second housing component having an inlet opening spaced from the outlet opening of the first housing component. The first housing component is pivotally coupled to the second housing component about a pivot axis. The first and second housing components are pivotable relative to one another about the pivot axis between a closed configuration in which the first and second housing components define an enclosed interior space and an open configuration in which the first and second housing components define an access opening in communication with the interior space.

[0005] In another aspect, one embodiment of the holding chamber further includes a cap movably coupled to the first housing component, the cap movable between a closed position in which the cap engages the second housing component to hold the first and second housing components in a closed configuration and an open position in which the cap disengages from the second housing component such that the first and second housing components are pivotable to an open configuration.

[0006] In yet another aspect, one embodiment of a sealable backpiece for a holding chamber has a flexible membrane including a plurality of flexible sections separated from one another by a plurality of slits that define free edges of the flexible sections, the flexible sections being movable relative to one another between a closed configuration in which the free edges of adjacent flexible sections are positioned adjacent to one another and an open configuration in which the flexible sections deform to form an entrance opening, the slits defining only one opening through the flexible membrane in the closed configuration, and at least two of the free edges of the flexible sections are spaced apart from one another and do not intersect each other when the flexible sections are in the closed configuration.

[0007] In yet another aspect, an embodiment of a method of using a drug delivery system includes moving a first housing component from a closed configuration to an open configuration relative to a second housing component, the first housing component having a user interface with an exit opening and the second housing component having an entrance opening spaced from the exit opening of the first housing component. The method further includes removing a pressurized metered dose inhaler disposed between the first and second housing components through an access opening formed between the first and second housing components in the open configuration, moving the first and second housing components from the open configuration to a closed configuration, thereby forming a sealed internal chamber, inserting a portion of the inhaler through the entrance opening, and dispensing a drug from the inhaler into the internal chamber defined by the first and second housing components disposed in the closed configuration.

[0008] In yet another aspect, one embodiment of a holding chamber has a housing component having a user interface end portion with an outlet opening and an elliptical valve seat with an outer circumferential edge. An inlet valve has a central elliptical opening with an inner circumferential edge that overlaps the outer circumferential edge of the valve seat. The inlet valve is movable between an inlet configuration in which at least a portion of the inner circumferential edge is spaced from the outer circumferential edge and an exhalation configuration in which the inner circumferential edge engages the outer circumferential edge.

[0009] Various aspects and embodiments provide significant advantages over conventional holding chambers. For example, the holding chamber can house the MDI in a protective storage position, without the invention being limited thereto. The holding chamber completely encases the MDI and holds it in a tight, rattle-free arrangement. In one embodiment, the holding chamber is water-resistant. At the same time, the holding chamber can be quickly and easily opened to allow access to the MDI, allowing the patient to quickly remove the MDI from the interior space and insert it through the backpiece for use. The cap maintains the holding chamber in a closed configuration and prevents its inadvertent opening, for example if it is accidentally dropped, while also covering the mouthpiece entrance opening to prevent contamination of the interior space of the holding chamber.

[0010] The above paragraphs have been provided by way of general introduction and are not intended to limit the scope of the invention which is set forth in the following claims. Various preferred embodiments, together with further advantages, will be best understood by reference to the following detailed description taken in conjunction with the accompanying drawings, in which:

[0011] The figures show various embodiments of a drug delivery system, a holding chamber, and methods of use and assembly thereof. [Brief description of the drawings]

[0012] [Figure 1] FIG. 2 is a side view of one embodiment of a valved holding chamber in a closed storage configuration with the cap in a closed position. [Diagram 2] FIG. 13 is a side view of the valved holding chamber in a closed configuration with the cap in an open position. [Diagram 3] FIG. 2 is a side view of a valved holding chamber in an open configuration. [Figure 4] FIG. 2 is a side view of the valved holding chamber in a closed storage configuration with the cap in a closed position and a metered dose inhaler disposed within the valved holding chamber. [Diagram 5]FIG. 2 is a side view of the valved holding chamber in a closed use configuration with a metered dose inhaler coupled to the inlet opening of the valved holding chamber. [Figure 6] FIG. 13 is an end view of the valved holding chamber in a closed storage configuration with the cap in an open position. [Figure 7] FIG. 13 is a bottom perspective view of the valved holding chamber in a closed storage configuration with the cap in an open position. [Figure 8] FIG. 1 is a top view of the valved holding chamber in a closed storage configuration with the cap in an open position. [Figure 9A] FIG. 2 is a perspective view of a first housing component. [Figure 9B] FIG. 2 is a side view of the first housing component. [Figure 10] FIG. 13 is a side view of the user interface with the cap in the closed position. [Figure 11] FIG. 2 is a perspective view of the user interface with the cap in an open position. [Figure 12] FIG. 13 is a side view of the user interface with the cap in the open position. [Figure 13] FIG. 13 is a perspective view of a second housing component. [Figure 14A] FIG. 13 is an end view of the second housing component. [Figure 14B] FIG. 13 is a perspective view of a second housing component. [Figure 15] FIG. 1 is a perspective view of an MDI engagement component. [Figure 16] FIG. 2 is a side view of a valved holding chamber in an open configuration with the cap in an open position and a metered dose inhaler disposed within the interior space of the holding chamber. [Figure 17] FIG. 2 is a first exploded perspective view of a valved holding chamber. [Figure 18] FIG. 13 is a second exploded perspective view of the valved holding chamber. [Figure 19] FIG. 2 is an exploded side view of a valved holding chamber. [Figure 20]FIG. 13 is an exterior perspective view of a sealable backpiece for a valved holding chamber. [Figure 21] FIG. 2 is a perspective view of the sealable backing from the inside. [Figure 22] FIG. 2 is a front view of a sealable backpiece. [Figure 23] 23 is a cross-sectional view of the backpiece taken along line 23-23 of FIG. 22. [Figure 24] 24 is a cross-sectional view of the backpiece taken along line 24-24 of FIG. 22. [Diagram 25] FIG. 23 is a side view of the backpiece shown in FIG. 22. [Figure 26A] FIG. 13 is an internal view of the backpiece in a closed position. [Figure 26B] FIG. 2 is an internal view of the backpiece in an open configuration. [Figure 27] FIG. 2 is a perspective view of the back piece from the inside. [Figure 28] FIG. 13 is a cross-sectional view of the user interface showing the inhalation and exhalation valves. [Figure 29] FIG. 2 is a cross-sectional view of a portion of a relief valve. [Diagram 30] FIG. 2 is a perspective view of the inhalation and exhalation valves. [Diagram 31] 1 is a flow diagram of various embodiments of a valved holding chamber. [Diagram 32] 11 is another flow diagram of various embodiments of a valved holding chamber. [Diagram 33] 11 is another flow diagram of various embodiments of a valved holding chamber. [Diagram 34] 11 is another flow diagram of various embodiments of a valved holding chamber. [Diagram 35] 11 is another flow diagram of various embodiments of a valved holding chamber. [Diagram 36] 11 is another flow diagram of various embodiments of a valved holding chamber. [Figure 37] 11 is another flow diagram of various embodiments of a valved holding chamber. [Figure 38] 11 is another flow diagram of various embodiments of a valved holding chamber. [Figure 39] 11 is another flow diagram of various embodiments of a valved holding chamber. [Diagram 40] FIG. 13 is an enlarged partial cross-sectional view showing the interface between the cap and the first and second housing components (including the user interface). [Diagram 41] FIG. 13 illustrates the user interface and the interface of the cap in a closed position. [Diagram 42] FIG. 2 is a partial end view of the cap in a closed configuration. [Diagram 43] FIG. 2 is a top view of the valved holding chamber with the cap in the closed position. [Diagram 44] FIG. 2 is an enlarged partial cross-sectional view of a latch interface between a first housing component and a second housing component. [Diagram 45] FIG. 2 is a partial perspective view of a valved holding chamber with the cap in an open position. [Figure 46] FIG. 2 is a partial top view of a valved holding chamber with the cap in an open position. [Figure 47] FIG. 47 is a cross-sectional view of the valved holding chamber with the MDI in a stored state taken along line 47-47 of FIG. 43. [Figure 48] FIG. 48 is a cross-sectional view of the valved holding chamber with the MDI in a stored state taken along line 48-48 of FIG. 43. [Figure 49] 13 is a cross-sectional view of a portion of a valved retention chamber with an alternative backpiece; FIG. [Figure 50] 13 is a cross-sectional view of a portion of a valved retention chamber with an alternative backpiece; FIG. [Figure 51] 13 is a cross-sectional view of a portion of a valved retention chamber with an alternative backpiece; FIG. [Figure 52] 13 is a cross-sectional view of a portion of a valved retention chamber with an alternative backpiece; FIG. [Figure 53] 13 is a cross-sectional view of a portion of a valved retention chamber with an alternative backpiece; FIG. [Figure 54]13 is a cross-sectional view of a portion of a valved retention chamber with an alternative backpiece; FIG. [Figure 55] 13 is a cross-sectional view of a portion of a valved retention chamber with an alternative backpiece; FIG. [Figure 56] 11A-11C illustrate an opening sequence of a valved holding chamber. [Figure 57A] 13A-13C illustrate another embodiment of an anti-rattle feature. [Figure 57B] 13A-13C illustrate another embodiment of an anti-rattle feature. [Figure 58] 13A-13C illustrate another embodiment of an anti-rattle feature. [Figure 59] 13A-13C illustrate another embodiment of an anti-rattle feature. [Figure 60] 13A-13C illustrate another embodiment of an anti-rattle feature. [Figure 61] 13A-13C illustrate another embodiment of an anti-rattle feature. [Figure 62] 13A-13C illustrate another embodiment of an anti-rattle feature. [Figure 63] FIG. 13 illustrates a partial cross-sectional view of an embodiment of a valved retention chamber with a suppressor feature. [Figure 64] FIG. 13 illustrates a partial cross-sectional view of an embodiment of a retention chamber with counterflow features. [Figure 65] FIG. 2 illustrates a partial cross-sectional view of an embodiment of a valveless holding chamber. [Figure 66] FIG. 2 is a perspective view of the inhalation and exhalation valves. [Figure 67] FIG. [Figure 68] FIG. 2 is a perspective view of one embodiment of a backpiece. [Figure 69] FIG. 2 is a partial interior view of a pressurized metered dose inhaler disposed within a holding chamber. [Figure 70] 1A-1D illustrate an assembly process for one embodiment of a holding chamber. [Figure 71] FIG. 13 is a partial cross-sectional view of an anti-rattle component secured to a retention chamber. [Figure 72]72 is a cross-sectional view of an anti-rattle component secured to the retention chamber taken along line 72-72 of FIG. 71. [Figure 73] FIG. 13 is a partial perspective view of a holding chamber having indicator markings applied thereto. [Fig. 74A] FIG. 13 is a front perspective view of an anti-rattle component mounted in a retention chamber. [Fig. 74B] FIG. 13 is a front perspective view of an anti-rattle component mounted in a retention chamber. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0013] It should be understood that the term "plurality" as used herein means two or more. The term "coupled" means directly coupled or indirectly connected or engaged, for example, with an intervening member, and the engagement need not be fixed or permanent, although it may be fixed or permanent (or may be integral), and includes both mechanical and electrical connections. As used herein, "first", "second", etc. are not meant to be assigned to the particular components so designated, but rather simply refer to such components in the designated numerical order, such that a component designated as a "first" may later be a "second" such component, depending on the order of reference thereto. It should also be understood that the designations "first" and "second" do not necessarily mean that the two components or values ​​so designated are different from one another, such as, for example, that a first component may be identical to a second component, each simply referring to separate but identical components. The term "longitudinal" refers to a length direction 2 or axis and extends along the flow direction of the holding chamber. The term "lateral" refers to a transverse direction 4 or axis perpendicular to the longitudinal direction. As used herein, "upstream" and "downstream" refer to the direction of gas flow during the inhalation (breathing in) and exhalation (breathing out) sequences of the respiratory cycle. As used herein, "exhale" and "exhale" are used interchangeably.

[0014] 1-8, a holding chamber 6 includes a first housing component 8 and a second housing component 10. In one embodiment, the first housing component includes a body portion 12 and a user interface portion 14 coupled to the body portion. It should be understood that the body portion and the user interface portion may be integrally formed with one another, such as when the holding chamber is configured without an intake valve. The body portion includes an end wall 16 with an outlet opening 18, a pair of side walls 20, and a spine wall 22 connecting the side walls, the side walls and the spine wall having a generally U-shaped cross section and defining a chamber wall and a portion of an interior space 24. The end wall 16 is generally dome-shaped with a convex outer surface 26 and a concave inner surface 28. A shoulder 30 or sealing ledge is formed at the interface between the end wall and the chamber wall. A plurality of tabs 32 extend from the end wall.

[0015] The outlet opening 18 generally surrounds in the lateral direction 4 a protective elongated central baffle 34 which, in various embodiments, is elliptical or oval in shape. A matching shaped, e.g., elliptical or oblong, valve seat 36 is formed by a periphery or rib of the baffle extending downwardly towards the user interface. A number of spokes 38 or connecting members connect the baffle to the end wall and define the outlet opening 18 therebetween, although it should be understood that the phrase "outlet opening" may include a single opening or multiple openings. A sealing ledge is formed around the periphery of the outlet opening facing downwardly towards the user interface. A longitudinally extending sidewall portion 42 extends from the sealing ledge.

[0016] The user interface portion 14 has a generally dome-shaped end wall 44 defining a cavity 47 sized to fit into the end wall of the body portion 12. The user interface portion has an outlet opening 46 aligned with the outlet opening 18 along the longitudinal axis and defined by a mouthpiece 50 with a lip portion, which may protrude slightly from the dome-shaped wall. The user interface portion has a plurality of openings 52 positioned to allow tabs to engage the end wall of the body portion by a snap-fit ​​engagement. It should be understood that the tabs and openings, which would otherwise be referred to as attachment features, may be reversed and positioned on the other of the body portion and the user interface portion, or the user interface portion and body portion may be joined by other fastener systems, friction fit, adhesives, and / or combinations thereof.

[0017] The user interface portion 14 has a pair of laterally spaced valve seats 54 facing in an upstream direction as shown in Figures 29 and 40. Additionally, a plurality of retention ribs 56 extend in an upstream direction toward the end wall 16. The retention ribs 56 overlap or rest on a sealing ledge 40 disposed about the periphery of the outlet opening. As shown in Figures 11, 12, 29 and 40, the user interface 14 has an inlet port 58 disposed in a grille 60 formed in the dome-shaped wall upstream of the valve seat, the port 58 communicating the flow channel with the surrounding environment. Various aspects of the valve, baffle and user interface are disclosed in U.S. Patent No. 6,293,279, the disclosure of which is incorporated by reference herein in its entirety.

[0018] 17-19, 28-30, and 66, a two-way valve 62 includes an inhalation valve portion 64 and an exhalation valve portion 66. The inhalation valve portion 64 has a central opening 68 shaped to overlie the baffle and a periphery 70 defining the inhalation valve sealing surface that engages the valve seat 36. In one embodiment, the opening 68 is oval or elliptical in shape. The oval shape of the valve allows for uniform opening and airflow during inhalation, resulting in better performance compared to traditional valve designs using radial symmetry. This valve is a functional two-way valve that is adapted to be included in the portable holding chamber design with minimal impact on size. Thus, the holding chamber provides good performance to the user while maintaining a small size due to the relative thinness or reduced width and portability of the case. The shape of the valve also results in repeatable uniform opening and flow during inhalation, thereby providing good device performance to the user, yet allowing the overall device to be narrower in width or depth.

[0019] Alternatively, as shown in Fig. 65, the holding chamber may have carefully considered geometries for the inhalation and exhalation flow paths to avoid disturbing the aerosol within the chamber. However, upon inhalation of the aerosol, an exhalation path is drawn from the holding chamber through the mouthpiece that does not provide positive or negative pressure to the volume of the holding chamber containing the aerosol. In this manner, valves may be eliminated with attendant cost savings, simplified manufacturing and assembly, and the elimination of attendant failure points and assembly steps.

[0020] The valve has a base portion 72 surrounding the inlet valve portion, and the exhalation valve portion 66 is configured as a pair of laterally spaced flaps extending from the base portion. The flaps have free edges 75 with sealing portions which underlie and engage the valve seat 54 formed on the user interface. The base portion has a longitudinally extending wall which surrounds and engages the wall 42 formed on the end wall 16.

[0021] The valve 62 is positioned on the end wall 16 with the base portion 72 engaging the sealing ledge 40 and the wall 74 abutting and engaging the side wall 42, the interface between the walls 42, 74 positioning the valve in the proper orientation and position. The user interface 14 is then coupled to the body portion 12 by the engagement of the tabs 32 and the openings 52, the valve 62 being captured between the user interface and the body portion with the sealing portion 70 of the inlet valve portion 64 engaging the inlet valve seat 36 and the sealing portion of the free edge 75 of the exhalation valve portion 66 engaging the exhalation valve seat 54. As shown in Figures 66 and 67, the valve 62 has a pair of alignment tabs or ribs 63 positioned on opposite sides of the base portion 72. The ribs 63 are disposed within recesses or openings 65 configured or formed on the exterior of the sealing ledge 40. It should be understood that the ribs 63 and openings 65 may be reversed, with the openings formed in the valve and the ribs formed on the sealing ledge. The ribs and openings may also be positioned anywhere along the base, such as at a 90° angle to the positions shown in FIGS. 66 and 67, or the valve may have more than two tabs. The rib placement shown in FIGS. 66 and 67 provides the greatest distance between the ribs, thereby creating the largest moment arm resisting rotation. The interface of the ribs 63 and openings 65 ensures that the valve is properly positioned against the sealing ledge 40 and prevents the valve from falling out or rotating / twisting about the longitudinal "z" axis.

[0022] The chamber wall has a curved edge 76 with an upper concave curvature 78 occurring along the sidewall adjacent the user interface and a lower convex curvature 80 occurring adjacent the opposite end with a transition therebetween. The width of the sidewall and associated depth of the interior space 24 decreases along the length of the chamber wall. An end 82 of the chamber wall opposite the end wall has an engagement member 84 which may be integrally formed with the body portion of the first housing component as shown in Figures 47 and 48 or may be formed separately and coupled to the first housing component by a snap fit as shown, for example, in Figures 9A, 9B, 15, 71, 72, 74A and 74B. The engagement member 84, in one embodiment, has a plurality of laterally spaced fingers or ribs 86, 88 that extend laterally from the spine 22 into the interior space and beyond the sidewall edge 76. In one embodiment, the engagement member has a centrally located primary rib 86 or finger and a pair of spaced apart secondary ribs 88 or fingers on either side of the primary rib or finger. The primary rib or finger extends laterally into the interior space a greater distance than the secondary ribs or fingers. Each rib or finger has an upstream facing engagement surface 90, 92 and a bearing surface. The end of the engagement member or body portion includes a hinge member that may have one or more lugs or lugs with axially aligned openings that define a pivot axis 98.

[0023] 71, 72, 74A and 74B, the housing component 10 has a recess 31 shaped to receive the rear wall of the engagement member and a slot 33 extending longitudinally from the edge of the recess. The slot 33 defines a track, which in one embodiment is dovetailed. The engagement member 84 has a rib 35, which may be located opposite the main rib, with a corresponding dovetailed edge slidably engageable with the track to secure the engagement member to the housing component by a press fit. After the body portion 12 is secured to the housing component 10, for example by a hinge pin, the engagement member is locked in place so that it cannot be removed. The ribs 86, 88 may engage the mouthpiece of the MDI, either individually or in combination, for example at spaced locations. Alternatively, the ribs may be provided on the interior of the mouthpiece, with a shape or engagement surface on the central rib 86 engaging the end of the mouthpiece of the MDI.

[0024] 14A, 14B and 17-19, the second housing component 10 has a body portion 100 having an end wall 102 with an inlet opening 104, a pair of side walls 106, and a spine wall 108 connecting the side walls, the side walls and spine wall having a generally U-shaped cross section and forming a portion of the chamber wall and interior space 110. The chamber walls, and in particular each side wall, have curved edges 112 with a lower concave curvature 114 adjacent the end wall and an upper convex curvature 116 along the side wall adjacent the user interface. The width of the side walls 106, and the associated depth of the interior space 110, decreases along the length of the chamber wall. The edges 76, 112 of the chamber wall are shaped to mate with one another. During shipping or other non-use, it is desirable to minimize the ingress of lint or other contaminants into the overall interior space or chamber 118 (see FIG. 47) defined by the combination of the interior spaces 24, 110 of each housing component in the closed configuration, since foreign objects that get into the VHC's interior chamber 118 could potentially be inhaled by the user. Thus, the first and second housing components 8, 10 that make up the body of the VHC can be sealed along any interface where the components meet to form a seam. This interface should form a seal that will prevent any dust or debris from entering the chamber 118 when the first and second housing components are in the closed configuration. In one embodiment, a bead of flexible material can be overmolded onto the component interfaces or edges 76, 112. The soft material is compressed to form the seal. Alternatively, the interface between the two components can be formed as a tongue and groove seam between the edges 76, 112 to provide a seal against the outside. Alternatively, the interface may include an O-ring disposed between or along one of the edges 76, 112 that are shaped and sized to match one another to provide a seal.In another alternative embodiment, the interfaces between the housing components, especially between the edges 76, 112, are provided with a notch joint to provide a seal against the outside. A combination of these interfaces may also be appropriate, for example, even if a lap joint and a seal are provided. A seal, for example a rubber or silicone bead, may be provided along one of the edges, so that the seal engages the other of the edges.

[0025] The sidewall includes a hinge component 120 that may have an axially aligned opening that, when aligned with the opening in the hinge component 96, defines the pivot axis 98. The openings in the first and second housing components are aligned with one another and a hinge pin 122 passes through the openings in the hinge components 96, 120 and pivotally connects the first and second housing components to one another. It should be understood that one or both of the first and second housing components may include an integrally formed hinge pin that engages the other of the housing components or the components may be coupled to a living hinge.

[0026] 44, the first and second housing components 8,10 are releasably coupled to a latch or detent that includes a pair of resilient tabs or fingers 124 extending from the first housing component that correspond and engage notches 126 formed on the second housing component. When the first and second housing components are pulled apart with sufficient force, the fingers 124 flex inwardly and disengage from the notches 126, thereby allowing the housing components to be separated from one another. It should be understood that the fingers and notches could be located on the other of the first and second housing components.

[0027] Grips 128 are provided on one or both side walls 106 of the second housing component to aid in gripping and applying a pulling force to the housing component. The grips 128 also provide a visual cue to the user as to where to grab the housing component. The grips are formed as slightly recessed areas that blend seamlessly into the exterior surface of the device. Alternatively, the grips may be provided on the first housing component or on both housing components. The grips 128 may be textured, may comprise a soft material, or may be formed as any shape or addition to a portion that helps the user to grip with enough force to overcome the body latches 124 / 126 and open the case.

[0028] As a variation, once the cap is in the open position, a tab 130 is revealed and extends upward from the spine 108 or from another portion of the second housing component as shown in Figures 45 and 46. The tab 130 engages the cap 132, which prevents the housing component from opening when the cap is in the closed position, as will be further described below. A user can pull the tab 130 with a finger or fingernail to open the body. The tab 130 is designed with a profile cutout 134 so that this design is simple and comfortable for the user. Conversely, the cap 132 may have features, such as a tab 136, to help open the cap and overcome the latching feature between the cap and the user interface. The tab 136 may have a slight overhang that allows the user to push the cap and provide force in the correct direction to open the cap.

[0029] Referring to FIG. 73, instructional indicia 101, which may include alphanumeric characters, such as the numbers "1" and "2," and directional indicia, such as arrows, provide the user with instructional information or visual clues as to the sequence of how to open and use the device. The instructional indicia may be molded into the plastic or affixed with an adhesive. For example, the number 1 with a first arrow instructs the user that the cap should first be opened and pushed in the direction of the particular arrow. The number 2 with a pair of second directional arrows informs the user that as a second step, the two housing components should be opened by moving them in opposite directions to each other.

[0030] As noted, the first and second housing components (collectively referred to as the body) open along a dividing line defined by edges 76, 112, which runs diagonally across the center of the device intersecting the longitudinal axis between the user interface outlet and the inlet opening. The dividing line is a stylized curve, so that the MDI is cradled by one side of the chamber when inserted into the body interior space in the storage configuration. One of the two housing components that make up the chamber body (e.g., the first housing component 8), or the portion thereof that makes up the observation window, is preferably "see-through," meaning that the one housing component is clear, semi-transparent, transparent or translucent, and the other (e.g., the second housing component 10) is opaque. This provides a unique visual impression that is accentuated by the curved contour of the line dividing the two housing components. A "see-through" component or window allows a user to visually verify that a medication administration device, such as an MDI, is present within the case at any given time without opening the case.

[0031] The device is intended to be carried "around" with the user and therefore must be comfortable and unobtrusive. The cross-sectional shape of the device must therefore be no thicker than necessary to fit into an MDI. A smooth exterior surface ensures there are no sharp edges, hinges or fasteners that could catch in a pocket or poke the user.

[0032] 20-27, 68 and 69, the backpiece 138 has a carrier 140 configured as a ring. The carrier 140 has a number of tabs 142 that engage with a perimeter or internal catch portion 105 of the inlet opening 104 in the end wall 102 to provide a snap-fit ​​connection. The carrier may also engage with the end wall or chamber wall by friction fit, fasteners, adhesives, or the like. A flexible membrane 144 is secured to the carrier, for example by overmolding. The membrane has a rim portion 146 secured to the carrier. The rim portion includes an end wall 150 and a side wall 152, and is joined to the side wall 152 with a central portion 148 extending across the inlet opening. The side wall and central portion of the membrane are bowl-shaped, with the central portion spaced in a downstream direction from the end wall. Thus, the surface is offset inwardly from the inner surface of the end wall and the side wall defines a channel or cavity 155 which leads to a flexible section or flap to increase retention when an MDI is inserted. The membrane 144 is chemically bonded to the carrier 140 which engages the end wall of the second housing component across the entrance opening, for example by a snap fit.

[0033] The central portion 148 has a number of flexible sections 154, 160 separated from one another by a number of slits 156 that define free edges 162 of the flexible sections.

[0034] The flexible sections can move relative to one another between a closed configuration in which the free edges 162 of adjacent flexible sections are positioned adjacent to one another as shown in FIG. 26A, and an open configuration in which the flexible sections deform to form an inlet opening 164 as shown in FIG. 26B. The slits 156, including the end relief openings 158, constitute the only openings through the soft membrane in the closed configuration. In one embodiment, the plurality of flexible sections includes at least four flexible sections 154, while the preferred embodiment includes six flexible sections, four central flexible sections and two end flexible sections. The end flexible sections 160 are generally triangular with a pair of free edges 162 and bounded edges 164 connecting the flexible section to the sidewalls and forming an integral hinge. The central flexible section 154 is generally quadrilateral with three free edges 152 and bounded edges 164 connecting the flexible section to the sidewalls and forming a free edge. Each of the central flexible sections has an innermost free edge that extends parallel to one another, with the opposing free edges abutting one another. A slit formed between the opposing free ends defines an axis 166 that intersects with an apex 168 of the end flexible section 160. The slit 162 between the four central flexible sections 154 defines or has a cross, "T" or "X" shaped opening. The free edge 162 of each of the flexible sections is straight in one embodiment, although it should be understood that the free edges may be non-straight, for example curved or curvilinear. The free edges 162 and the apex 168 of the two end flexible sections are spaced apart from one another and do not intersect when the flexible sections are in the closed configuration.

[0035] The inlet opening 165, which is formed by a flexible section in an open configuration, defines a first area A1. The slit defines a second area A2, where A2 < A1. The relief opening 158 is positioned at the end of the slit 156 and forms part of the slit. The relief opening 158 has a width, for example a diameter if it is circular, and this width is greater than the width of the slit 156 at the end location of the relief opening. The relief opening 158 serves to reduce stress concentration and prevent the slit from propagating (e.g., by tearing) into the edge portion, while enhancing the flexibility of the flexible section. The relief opening may be positioned in or extend into the sidewall of the edge portion as shown in FIG. 20. In one embodiment, the relief opening configured as a round notch reduces tearing of the component and reduces the insertion and extraction forces for different forms of MDI. These features, together with the channel, enable the MDI to remain coupled to the device during use while allowing the user to comfortably insert and remove the MDI without applying excessive force.

[0036] In one embodiment, the back piece 138 has a plurality of supports 139 extending longitudinally from the membrane 144 or carrier. These supports comprise a pair of laterally extending extensions or posts 141 spaced apart from each other, with a curved support surface extending between these laterally extending extensions or posts and partially formed by the posts. The support surface is shaped to engage the mouthpiece portion of a pressurized metered-dose inhaler as shown in FIG. 69. The engagement location is offset by a distance LO from the location where the rib 86 engages the opposing surface of the mouthpiece portion, such that the supports 139 and the rib 86 apply a moment force to the mouthpiece and the pressurized metered-dose inhaler, thereby rotating the pressurized metered-dose inhaler and abutting it against the rib 224, which will be further described below. In this way, the pressurized metered-dose inhaler is firmly held in the holding chamber and does not rattle around within the holding chamber.

[0037] The inlet opening 165 and the outlet opening 48 of the mouthpiece are substantially aligned along the longitudinal axis 2 when the first and second housing components are in the closed configuration as shown in Figures 1 and 2, with the inlet and outlet openings being perpendicular to the longitudinal axis. During inhalation, air and medication follow a flow path through the inlet opening into the internal chamber, through the outlet opening when the inhalation valve is open, and through the outlet of the mouthpiece to the user's airway. During exhalation, the flow path passes through the user interface, through the exhalation valve and out the exhalation opening.

[0038] 1-3, 10-12, 16-18, 41-43, 47 and 48, the cap 132 is movably connected to the user interface portion of the first housing component. Alternatively, the cap may be movably connected to the second housing component. The cap has an end wall 169 and side walls 170 defining a cavity 172 that receives the mouthpiece 50 of the user interface portion when the cap is in the closed position. In one embodiment, one or both of the side walls 170 are pivotally connected to the user interface portion about one or more pivot axes 166. The side walls have a recessed cutout portion 174 and a pair of hinge components 176 are provided along the bottom edge. The hinge components are configured as lugs in one embodiment with the tips of the lugs facing inwardly so that the lugs are not parallel to one another. The user interface has a pair of pivot pins 178 that are aligned with the hinge components. The configuration of the hinges 176, 178 allows the outer surface of the user interface portion and the cap sidewall to be flush with a convex curvature. The cap end wall has curved edges on all sides where it transitions to the sidewall 170, which provides a smooth surface and helps prevent the device from getting caught when placed in a pocket or bag. For example, the hinge between the cap and the mouthpiece allows the device to remain streamlined and the hinge does not protrude outwardly from the outer contoured surfaces of the cap and housing components, but rather remains flush with the contoured surfaces of the device.

[0039] In one embodiment shown in FIG. 70, the hinge assembly includes a straight hinge axle 177 extending between opposite sides of the cap sidewalls 170. The hinge axle 177 has a pair of cylindrical portions 181 and an intermediate detent portion 179. The detent portion 179 holds the cap in an open position while the instrument is in use. The detent provides a resistive torque through one revolution of the cap. During assembly, the hinge axle 177 is received in a pocket or socket 183 provided in an end portion of the body. The user interface portion has a downward facing socket 185 that captures or locks the axle 177 in the socket when the user interface portion is coupled to the body, for example by a snap fit.

[0040] In other embodiments, the cap may be translatably coupled to the user interface portion, for example by a sliding and / or friction fit connection, or may be completely uncoupled from the user interface portion, or may be secured to the user interface portion by a tether. A bottom edge of the cap is shaped to mate with one formed on the user interface portion.

[0041] The side wall opposite the hinge has a downwardly opening lip 180 defining a recess therebelow. The tab 130 on the second housing component is captured by the lip 180 and placed into the recess when the cap is in the closed position and the first and second housing components are in the closed configuration as shown in FIG. 1, so that the chamber or the first and second housing components do not inadvertently open, for example in the event of being dropped. The side wall and a portion of the spine wall include a raised oval or elliptical shaped profile 182 that provides a visual indicator for the user to engage and rotate the cap. This portion of the spine wall may have a slight indentation 184 that can receive the user's thumb or other finger when lifting the cap.

[0042] One side of the cap has a pair of resilient tabs 186 that releasably engage posts 188 on the user interface that have a curved profile that forms part of the grille that defines the call port, the tabs and posts forming a latch. The tabs 186, or fingers, or latch hold the cap such that it cannot be opened unless a user exerts a force on the cap lip 180 biasing the tabs about the curved profile until they are disengaged from the posts 188. A torsion spring 190 may be provided about the pivot pin that forms the hinge and engages between the user interface and the cap to bias the cap away from the user interface and maintain the cap in the open position.

[0043] Exemplary materials for the various components are listed in Table 1. Additionally, the cap may be made of Acetal Celcon M90, the backpiece membrane may be made of Elastosil LR3071 / 40 (40 durometer), and the substrate may be made of Sabic Valox 420.

[0044] Asthma sufferers generally experience exacerbations at night, making it difficult for them to get up and locate their medication in a dark room. Also, it may be difficult to find the MDI or holding chamber in the bag if the bag is not well lit. By making the device (e.g., one or more of its components) glow in the dark, the user can quickly locate and administer their medication without having to turn on a light or hunt around in the dark. The glow in the dark can be implemented in the body and / or cap, making them easily visible in a dark space. By making the device visible in the dark by providing some form of glow in the dark, the user will be able to quickly locate their medication even if they are woken up by an exacerbation. This minimizes stress for the user, since they do not have to spend time and energy hunting around for the device or light. This has the added benefit of reducing disruptions to the user's sleep cycle, thereby potentially improving the user's restful night's sleep. It may be suitable to incorporate a glow in the dark additive into the component material of one or more components. This will cause any part that contains a glow-in-the-dark additive to glow in the dark throughout the part. In an alternative embodiment, glow-in-the-dark ink may be printed in one or more locations on the exterior of the device to produce some light in a dark space.

[0045] TIFF2025010138000002.tif77156 Table 1: Materials

[0046] assembly 17-19, the first housing component 8 and the second housing component 10 are pivotally connected to one another with a hinge pin 122 inserted into the hinge components. The first and second housing components are pivotable relative to one another about a pivot axis 98 between a closed configuration in which the edges 76, 112 abut one another and the first and second housing components define an enclosed interior space 24, 110, 118, and an open configuration in which the first and second housing components define an access opening 192 in communication with the interior space 118. A latch or detent secures the first and second housing components together in the closed configuration.

[0047] The backpiece 138 is connected to the second housing component 10 by a snap fit, with the flexible membrane 144 closing the inlet openings 165, 104. The inlet valve 62 is provided in the end wall 16 of the first housing component, with the sealing ledge 40 engaging the base portion 72. The user interface 14 is then fitted to the end wall, with the inlet valve 62, and in particular the base portion 72, being clamped between the user interface and the end wall, the user interface engaging a tab 32 provided on the end wall.

[0048] The cap 132 is coupled to the user interface 14 by at least one hinge pin 178 that engages a hinge component 176 on the cap, whether separate or integrally formed. The cap can be moved from a closed position, in which a lip 180 of the cap engages a tab 130 of the second housing component to maintain the first and second housing components in a closed configuration, to an open position, in which the cap, and in particular the lip 180, is disengaged from the second housing component or an edge thereof, thereby allowing the first and second housing components to be pivoted to the open configuration by releasing a latch or detent between the first and second housing components with a spring 190 biasing the cap to the open position.

[0049] In this way, the first latch is movable between a latched configuration in which it secures the first and second housing components in a closed configuration and an unlatched configuration in which the first and second housing components can be moved to an open configuration, and the second latch is movable between a latched configuration in which the second latch secures the cap to one of the first and second housing components in a closed position and an unlatched position in which the cap can be moved to an open position. The first latch is movable from the latched configuration to the unlatched configuration only when the second latch is in the unlatched configuration. Thus, the device comprises a redundant double latch system that prevents the device from being opened inadvertently, whilst still allowing intuitive use, meaning that when the cap is opened, thereby exposing the mouthpiece, the second latch is also disengaged, so that the first latch is also disengaged, so that the holding chamber can be opened and the drug delivery device (e.g. a pressurized metered dose inhaler) can be removed.

[0050] 3, 16, 47 and 48, a pressurized metered dose inhaler (MDI) 200 has a canister 202 with a stem 204 and an actuator boot 206. The boot has a chimney 208 with a cavity 218, a well 216 at the bottom of the cavity and a mouthpiece 210 extending laterally from the chimney. The canister is mounted within the chimney and the stem is received within the well. A top end 212 of the canister can be pressed against the bottom of the actuator boot 206, causing the stem to move relative to the canister, thereby opening a valve to release the medication contained within the container through an outlet formed in the well. The outlet is directed downwardly towards an outlet opening 214 in the mouthpiece. An MDI is placed into the interior space 18 through the access opening 192 and the bottom of the mouthpiece abuts the inside surface of the backpiece and the engagement ribs 86, 88 engage the top of the mouthpiece 210. The front 210 of the mouthpiece engages the bearing or engagement surface 92 of the engagement member. The rear surface 224 of the chimney engages a rib 224 formed along the interior of the first housing component.

[0051] In this manner, the MDI is held securely within the interior space so that it cannot move around. By holding the MDI 200 in a fixed position, it is protected from accidental actuation, any physical damage, and rattling within the case. Preventing rattling within the case is an important factor since this is a portable device, as any tactile or audible feedback upon any movement, such as a step forward with the device in a pants pocket, may be considered irritating by the end user. The exact geometry of the various ribs 86, 88, 224 will depend on the shape and dimensions of the MDI, and the ribs can be adapted to create a snug fit with any manufacturer's design. For example, in one embodiment, a rib 224 located in the center of the inner wall of the second housing component controls the seating angle of the MDI by shortening the rear of the chimney. One or more ribs 86, 88 on the first housing component rotate into position when the body is closed, thereby contacting and depressing the top of the MDI mouthpiece 210. The engaging member 84 may be manufactured as a separate piece so that different engaging members designed to engage differently shaped MDI devices may be coupled to the modular holding chamber, for example by a snap fit.

[0052] action 1, the holding chamber 6 is in a closed configuration with the cap 132 engaged with a second housing component 10 (body 12 or user interface 14) which is engaged with the first housing component 8. Closing the device latches the cap 132, which captures at least one other of the holding chamber components, such that the housing components 8, 10 cannot be rotated open to allow access to the medication (e.g., MDI 200) until the cap 132 is opened and unlatched. In this manner, the cap 132 provides an additional level of security to the MDI in the event of a drop or other impact.

[0053] The flexible membrane 144 is in a closed configuration such that the entire interior space of the chamber 118 is sealed from the surrounding environment. A user can look through the first housing component 8 to see that the MDI 200 is stored within the holding chamber.

[0054] To use the device, the user first opens the cap 132 by grasping the lip 180 of the cap that sits over the recess and rotating the cap to the open position, where a resilient tab / finger 186 (i.e., latch) on the cap disengages from a post 188 and a spring 190 biases / maintains the cap in the open position. The cap may be rotated to an angle of, for example, 145°, allowing room for the user to access the mouthpiece.

[0055] The user then grasps the side walls 20, 106 of the first and second housing components and rotates them from the closed configuration to the open configuration by releasing the second latch, thereby creating an access opening 192 that communicates with the interior space 118. The first and second housing components rotate open up to an angle of 45°, thereby allowing the MDI to be comfortably inserted and withdrawn through the access opening 118. Operation of the device is ambidextrous. It should be understood that the term "interior space" refers to the space defined by each of the first and second housing component chamber walls individually when in the open configuration and together when in the closed configuration. The user can then remove the MDI 200 through the access opening 192, which is rotated away from the engagement member 84.

[0056] The device must continue to function as an MDI case even if it is dropped or otherwise subjected to sudden force. If the case were to open during such an event due to failure of the latching mechanism or any other part of the device, the user's medication could fall out and be lost, damaged, or otherwise rendered unusable. A two-stage opening process using two separate latching mechanisms helps ensure the integrity of the system.

[0057] Although it acts as a case for the MDI, the user should be able to quickly and easily remove his medication from the device. The opening mechanism is designed to emphasize ease of access. This is accomplished by splitting the body into two sections along the length of the device, which are hingeable about a pivot axis 98 near the backpiece and the entrance opening 104. This provides a relatively large access opening 192, allowing easy and comfortable removal and storage of the MDI. The split is shaped such that the body cradles the MDI while allowing comfortable and easy user access. In other words, the cavity of the second housing component is increased in depth to receive and cradle the MDI and its mouthpiece. Thus, the wide opening case provides comfortable storage and removal of the MDI in the VHC. The split curve of the body is designed to maximize this ease of use.

[0058] After the MDI 200 is removed, the first and second housing components 8, 10 can then be pivoted / rotated back to the closed position as shown in Figure 2 and re-latched. The mouthpiece 210 is then inserted through the membrane 144 and the flexible sections 154, 160 move relative to each other so that the mouthpiece outlet 214 is located within the interior space 118. To protect the MDI and ensure that the inside of the device remains clean, the inlet should be sealed off when not in use. This is achieved by using a soft material, e.g. silicone, to form a resilient flap or flexible section so that when the MDI mouthpiece is inserted, the flap or flexible section opens inwards. When the MDI is removed, the flexible section returns to its natural closed position to protect the interior space within the body.

[0059] The user may insert the mouthpiece 50 into their mouth and the MDI 200 is actuated by pressing on the top end 212 of the container and the actuator boot 206, which causes a dose of medication to be dispensed into the chamber 118. Upon inhalation by the user, medication flows through the outlet opening of the inhalation valve 64, through the mouthpiece 50, and into the user's airway. During exhalation, the inhalation valve closes and the exhalation valve 66 opens, thereby permitting the flow of air through the user interface, out the exhalation port, and into the surrounding environment. After a given treatment, the mouthpiece may be removed from the backpiece and the user may rotate the first and second housing components 8, 10 to an open configuration. The mouthpiece 210 can then be snapped into the second housing component while resting against the rib 224, and the first and second housing components can then be rotated to the closed configuration such that the ribs 86, 88 engage the mouthpiece 210 and the detents (i.e., the first latch) engage. The cap 132 can then be rotated to the closed configuration with the resilient tab / fingers 186 (i.e., the first latch) engaging the post 188 of the user interface.

[0060] The portable holding chamber acts as a storage case for the MDI, encouraging the user to store their MDI within the chamber, while the overall design minimizes concerns of external contaminants entering the chamber and being inhaled.

[0061] In another embodiment, when the MDI is stored in the instrument, it may be sterilized to ensure it is clean before each use. This may be accomplished by providing an ozone generator 226 in the instrument. An interlock is required as a safety feature to automatically turn off the ozone generator if the chamber is opened. Various levels of user control are possible, ranging from a fully automatic cleaning cycle to manual user control at each step. An ozone generator is provided in the chamber that produces ozone to neutralize any contaminants when the MDI is stored in the chamber. This component is connected to a safety shutoff so that if the chamber is opened, all ozone generators are stopped instantly. By allowing the MDI to be disinfected while it is stored in the case, it ensures that the MDI is free of contamination at any time. This provides peace of mind to the user and encourages the use of the instrument as a storage case. The system may have an internal timer that generates ozone according to a pre-set schedule, for example once a day at 10am for 7 minutes (soclean2 default setting). This simplifies the device for the user. Alternatively, the system includes an input device, such as a touch screen 228, and an output device, the same touch screen in this embodiment. The user manually sets the duration and start time of the ozone generation. The device allows the programming of daily or weekly schedules. The output device shows information when a treatment is taking place, such as the start time of the next treatment and the length of time since the last treatment. This gives the user better control over his device.

[0062] As an alternative to ozone treatment, the device may include one or more UV emitters 230 positioned to project UV light onto both the exterior and interior surfaces of the MDI. The portable VHC is intended to function as a storage case for the MDI. To reduce overall size, the MDI mouthpiece cap is discarded. The VHC should provide at least the same level of protection for the MDI as the mouthpiece cap.

[0063] Other Variations There is a need for an MDI interface that will accept the mouthpiece of an MDI to couple the MDI to a VHC and close or seal the opening while the MDI is stored within the VHC.

[0064] Referring to FIG. 49, the MDI inlet 304 may be made of a soft material and has a cork feature or plug 300 attached to the end of a short tether 302 that is to be pressed into the inlet when the VHC is not in use. This configuration creates a seal and prevents debris from entering the inlet opening. A single, integral component includes the MDI inlet 304 and plug 300 with matching geometries that allow the user to insert and remove the single, integral component. The plug may be connected to the MDI inlet with a tether of the same material and homogenous, integral construction. The use of a single, integral component provides an MDI interface that accepts the mouthpiece of the MDI to couple the MDI to the VHC and closes or seals the opening while the MDI is stored in the VHC.

[0065] Referring to Fig. 50, the MDI inlet 308 may be made of a soft material and is secured to a plug 310 made of a hard material and secured, for example, by adhesive, mechanical or chemical bonding. The connection is hinged such that when an MDI is inserted, the plug 310 can rotate and move out of the aerosol path within the chamber. The inlet 308 and hinge 312 may be integrally formed and one piece, with the hinge 312 having an undercut that allows it to pivot relative to the inlet. The plug is connected, for example, by a snap-fit ​​insert 314 having a catch that is inserted through an opening 316 in a flange 318. The plug 310 closes the opening of the MDI interface when no MDI is inserted. By molding the hinge flange 318 at an angle to a plane defined across the opening for the MDI, the flange 318 or hinge 312 has a preload that allows the flange or hinge to act as a spring to cover the inlet opening and close the plug. When the MDI is inserted, the configuration of the plug is such that it rotates past the MDI mouthpiece in the holding chamber. The plug may have a tapered surface 320 that acts like a cam and follower mechanism so that the plug moves or rotates and is urged by the MDI parallel to the chamber and flow path and hits the interior side wall of the holding chamber rather than out of the aerosol plume. The flexible interface and hinge system together with a rigid plug provides an MDI interface that accepts the mouthpiece of the MDI to couple the MDI to the holding chamber and close or seal the opening while the MDI is stored in the holding chamber. Thus, the system comprises an automatic closing system, with the hinge acting as the closure device or biasing member. Another spring may be provided to further bias the plug into the closed position.

[0066] Referring to Figure 51, the MDI entrance 330 is made of a flexible material and contains several flaps that form a flat surface across the MDI entrance. The flaps return to a closed position when an MDI is stored in the chamber and open inwardly when an MDI is inserted. The undersides of the flaps that make up the slit each have a beveled chamfer 332 at their corners at an angle β, which allows the flaps to align with each other when closed.

[0067] 52, in the closed position, the flap 334 forms a very small dome 336 with its concave surface facing the MDI. By forming the flap on a concave dome in the closed position, the flap will close precisely, uniformly, and more reliably than if the closure surface were flat.

[0068] Alternatively, referring to Figure 53, the flap 338 returns to the closed position to form a very small dome 340 that is convex relative to the MDI. By forming the flap into a convex dome in the closed position, the inlet is stable in the closed position yet resists entry of foreign objects such as dust and lint.

[0069] Referring to FIG. 54, the holding chamber serves as a storage container for the MDI when not in use. By inserting the MDI canister 202 into the interface from inside the holding chamber, a standard diameter of a canister, for example an asthma rescue medication canister, can be utilized by designing the MDI interface to allow the canister to be inserted and form a seal. This eliminates the need for additional parts or materials to close the MDI interface when the canister is in the storage position. Specifically, the MDI canister 202 is inserted into the MDI interface 360 ​​to seal the opening when the MDI is stored in the holding chamber. The MDI canister can be used to seal the MDI interface of the holding chamber when in the storage configuration. Eliminating the need for a separate feature to seal the interface simplifies the design and reduces costs. The flaps are flexible enough to allow them to flex further to accommodate the mouthpiece of the MDI when the MDI is removed from the holding chamber and inserted into the interface.

[0070] Referring to FIG. 55, a flexible element 370 extends into the interior of the holding chamber, which contacts the MDI, after which the flexible element can press against the MDI interface. The flexible element 370 can be integrally formed with the MDI interface 334, and when the MDI is stored in the holding chamber, it will retract without allowing the flaps to open. The flexible element 370 opens with the flaps in the interface when the MDI is inserted for use. The flexible element acts to capture the MDI and prevents rattling, while preventing the MDI inlet flap from being forced open by the MDI. This provides good protection for the device from physical damage and contamination from outside the storage case.

[0071] The device must continue to function as a case for the MDI even if it is dropped or otherwise subjected to sudden force. If the case opens in such an event due to failure of the latching mechanism or any other part of the device, the user's medication may fall out and be lost, damaged, or otherwise rendered unusable. As disclosed above and shown in FIG. 56, the VHC body is made of two halves 8,10 that are joined together by a hinge so that the body can be opened to allow access to the interior of the MDI. The two halves latch together with a detent and can fail in the event of a drop or impact. The mouthpiece cap 132 fits on top of the extension of the lower body half so that the body cannot be opened until the cap is lifted. The cap is held in place by a snap-fit ​​interface with the mouthpiece of the VHC. The lower body half 10 has an extended tab that overlaps the upper body half 8 when the two halves are latched closed by a detent feature. The mouthpiece cap 132 captures the tab in the closed position, locking the body halves together until the cap is opened. The cap has a snap fit or other latching mechanism to hold it in the closed position. These two latching mechanisms ensure that two separate actions are required to remove the MDI. A unique solution that utilizes existing parts of the device is to devise a two-step opening process with two separate latching mechanisms to be overcome. By using existing parts and the steps that must be performed to administer medication using the VHC, redundant protection is not added to complicate the use of the device. This ensures that a single impact or drop will not cause the MDI contained within the VHC to be released from the carrying case.

[0072] Referring to Figures 57A, 57B, 74A and 74B, the MDI, when acting as a storage case, must be sufficiently constrained within the device that it does not rattle during normal movement. This will protect the MDI from any damage within the case and eliminate the risk of accidental activation of the canister. The device is intended to be carried in a pocket, and the tactile and audible feedback of the MDI hitting the inner wall of the VHC is perceived by the user as being noisy, thereby discouraging the user from carrying the device. A set of ribs 86, 88 are provided on the inner surface of the holding chamber, each with a geometry designed to capture the mouthpiece design of the differently shaped MDI. The ribs are provided on one half of the body so that when the device is opened, the ribs rotate to allow space for the MDI to fit into the VHC, and when the body is closed, the ribs contact the MDI and secure it to the VHC, preventing it from moving. The first configuration of MDI to be accommodated, shown in Fig. 57A, is captured by a system of two ribs 86, 88, consisting of a rib with a flat bottom that captures the mouthpiece of the MDI between the rib and the bottom of the VHC to hold the VHC down, and a vertical rib that captures the side of the VHC to prevent it from rotating. The second configuration, shown in Fig. 57B, uses the remainder of the geometry, i.e. a shoulder 380, on the first rib 86 to hold the MDI upwards, while the other rib or its end portion 382 holds the MDI downwards. The top of the first rib has a flat face to prevent the MDI from rotating. In this case, both ribs are on the inside of the mouthpiece and they contact the inside face of the MDI mouthpiece. In this way, the same rib engages and captures and holds different configurations of MDIs and prevents them from rattling in the case. Preventing the MDI from rattling within the VHC helps give the user an impression of high quality and thought in the design of the VHC. The geometry of the anti-rattle ribs is modifiable to accommodate different types of MDI designs using the same concept to capture different shapes and dimensions in the same way.

[0073] Referring to FIG. 58, ribs 390 or grips made of a flexible material are provided within the holding chamber to be able to conform to the shape of a multitude of MDIs, each with a unique geometry. These flexible elements can be provided in a variety of sizes, shapes, and locations. The flexible elements within the holding chamber capture the MDI and prevent it from moving or rattling within the holding chamber. By making the ribs flexible, the dependency of very specific geometries can be avoided using one feature to capture many types of MDIs. Preventing the MDI from rattling within the VHC helps give the user an impression of high quality in the design.

[0074] Flexible ribs may be provided on opposing inner faces of the holding chamber so that the MDI is gripped between the inner faces. Flexible elements may be provided on the bottom or sides of the holding chamber so that the mouthpiece of the MDI cannot move once inserted. The ribs capture the mouthpiece and apply pressure to the sides and top of the part to hold it in place. As shown in FIG. 59, flexible elements 390 may be provided on the sides or bottom of the holding chamber so that the MDI canister is captured around its perimeter when it is inserted into the case. This is a similar design to the inlet seal that uses the MDI canister.

[0075] Referring to FIG. 60, elastic bands 400 extend along each side of the inside of the holding chamber, which may include a single band looped around the inside of the holding chamber. Elastic bands 400 are integrated into the opening of the holding chamber body, so that when an MDI is placed in the holding chamber when the holding chamber is closed, the elastic bands extending between the housing components 8, 10 capture or pinch the MDI to prevent movement within the holding chamber. Elastic bodies may be incorporated into the opening of the VHC to grip the sides of any MDI within the case. Using elastic bodies to capture many types of MDIs avoids the dependency on different specific geometries associated with different MDIs. Preventing the MDI from rattling within the VHC helps give the user an impression of high quality and thought in the design of the VHC.

[0076] Referring to Figure 61, one or more plastic ribs 420 on the inside walls of the holding chamber can capture the MDI when it is inserted straight in from the bottom. The bottom acts as a lid and captures the MDI against the ribs. The ribs 420 can be rigid or hard and can be on either side of the holding chamber so that the MDI is fixed in place when the cap 132 is closed over the top of the MDI. Using a single rib can capture multiple styles of MDIs by using different styles of openings, thereby avoiding dependency on a very specific geometry.

[0077] Referring to FIG. 62, ribs 420 on the inner walls of the holding chamber can capture an MDI when it is inserted straight in from the bottom. The ribs 420 fit into the space between the MDI canister and the plastic MDI boot, and the bottom acts as a lid to hold the MDI down against the ribs. The ribs 420 on the inner walls of the VHC are positioned such that when the MDI is inserted, the ribs fit or fit into the MDI between the boot and the canister, thereby locking it into place when the cap 132 is closed over the top of the MDI. Using one example rib design and different types of openings, multiple types of MDIs can be captured, thereby avoiding dependency on a very specific geometry.

[0078] Volume and length have a direct correlation with the aerosol output of the VHC, and therefore it is desirable to reduce the size of the holding chamber, but performance must be maintained. Details of the device's shape and overall size and feel, as well as the size of the device, affect the portability of the device.

[0079] Referring to FIG. 63, good aerosol dosing can be achieved in a small chamber by designing the holding chamber to slow down the aerosol as it enters the holding chamber. A series of baffles or deflectors 450 within the chamber redirect the entrained air laterally to slow down the central aerosol plume. The baffles 450 are within the body of the holding chamber and are positioned such that the baffles are outside of the central aerosol plume. The baffles extend radially outward and downstream from the central location. The baffles 450 deflect the entrained air laterally, slowing down the aerosol plume, cushioning the impact within the holding chamber and reducing the amount of drug that leaves the mouthpiece when the MDI is "fired". Baffles within the holding chamber can be used to slow down the aerosol plume and improve the drug output of the holding chamber. This allows the size of the holding chamber to be reduced without adversely affecting drug delivery.

[0080] Alternatively, the VHC may be designed to provide a counter-flow as shown in FIG. 64. Many current chambers use a "through" aerosol pathway. Pressure generated by MDI ignition can open the inhalation valve and aerosol may be lost if the chamber is too small. By changing the pathway, these losses can be prevented. The aerosol is directed into a closed section 460 of the VHC, which defines a cavity with an opening at the upstream end and is closed at the downstream end, where air acts as a cushion to slow down the plume. The closed section 460, located in the center of the VHC, includes a one-way valve 462 that allows air flow during inhalation but prevents flow through the center section when the MDI is ignited, thereby creating a pressure increase in the holding chamber. The air cushion created by closing the valve 462 slows down the aerosol plume and prevents loss of medication during MDI ignition. By altering the flow path of the aerosol within the holding chamber, an intermediate closed section containing an air cushion is created which slows the aerosol plume when the MDI is actuated within a VHC, improving medication delivery to the user.

[0081] In another embodiment, the VHC employs active counter-flow. It is envisioned that a fan or similar type of device may be used within the VHC to create a counter-flow, thereby slowing down the aerosol plume. This may be associated with an actuation detection so that it only activates when needed, thereby saving power consumption. The existing airflow or increased pressure within the VHC helps to slow down the aerosol, thereby improving drug delivery and device performance.

[0082] Smart Features Without a dose counter, it is impossible for a user to know exactly how much medication remains in their MDI canister. In markets where dose counters are not built into MDIs, patients have difficulty knowing when they need to refill their prescription. This problem is exacerbated because MDIs continue to ignite an aerosol plume of pure propellant even when the medication is depleted. This leaves emergency exacerbations untreated.

[0083] A drug detection system is provided that works by utilizing the absorption of light in the ultraviolet spectrum by albuterol, specifically, in this case, at a wavelength of 275 nm. Referring to FIG. 31, by measuring the intensity of ultraviolet light in the holding chamber using an ultraviolet light emitter and a corresponding sensor, the system can determine how much drug is in the holding chamber. The system includes an ultraviolet light emitter of the appropriate wavelength to be absorbed by albuterol and a corresponding analog ultraviolet light sensor to measure the amount of drug administered by the MDI. The sensor and emitter are mounted such that the MDI plume is between the emitter and the sensor. The ultraviolet light emitter and sensor may be located within the body of the VHC. This system allows the user to know when the MDI is out of drug without the need for a dose counter per se.

[0084] Referring to FIG. 32, there is shown a propellant detection system that works by utilizing the absorption of light in the infrared spectrum by the MDI propellant. By measuring the intensity of infrared light in the holding chamber using an infrared light emitter and a corresponding sensor, the system can determine how much propellant is in the holding chamber. When the MDI runs out of drug, the plume will be mostly composed of propellant. The system includes an infrared light emitter of the appropriate wavelength to be absorbed by the propellant and a corresponding analog infrared light sensor to measure the amount of propellant present in the holding chamber. The sensor and light source are mounted such that the MDI plume is between the emitter and the sensor. The infrared light emitter and sensor may be located within the body of the holding chamber. This system allows the user to know when the MDI runs out of drug without the need for a dose counter per se.

[0085] Referring to FIG. 33, a functional albuterol and propellant detection system is shown that functions by albuterol absorbing ultraviolet light and propellant absorbing infrared light. By measuring the intensity of ultraviolet light in the VHC using an ultraviolet light emitter and corresponding sensor, and infrared light in the holding chamber using an infrared light emitter and corresponding sensor, the system can measure the amount of propellant and drug in the aerosol plume. This allows the composition of the aerosol plume to be quantified. The system includes an ultraviolet light emitter of an appropriate wavelength to be absorbed by the albuterol and a corresponding analog ultraviolet light sensor to measure the amount of drug present in the VHC, and an infrared light emitter of an appropriate wavelength to be absorbed by the propellant and a corresponding analog infrared light sensor to measure the amount of propellant present in the VHC. The sensor and emitter pair is mounted such that the MDI plume is between the emitter and the sensor. The infrared light emitter and sensor and the ultraviolet light emitter and sensor can be located within the body of the VHC. This system allows the user to know when the MDI has run out of medication without the dose counter itself.

[0086] Referring to Figure 34, a sensor measures the amount of a particular composition in the aerosol plume. By providing a sensor in the body of the holding chamber, the system can use the sensor value to determine how many doses remain in the MDI. The system includes a sensor provided in the holding chamber body that measures the aerosol plume. A sensor is provided to obtain a reading of the aerosol plume in the holding chamber body. This allows the user to know when the MDI is out of medication without the dose counter itself.

[0087] Referring to FIG. 35, the liquid in the MDI canister indicates how much drug remains. This can be accomplished using an ultrasonic level sensor that is mounted in the holding chamber so that the canister remains against the sensor during storage in the holding chamber. An orientation sensor, such as a gyroscope, accelerometer, or magnetometer, ensures that measurements are taken in a consistent orientation. An ultrasonic sensor is mounted on the inner wall of the holding chamber opposite the anti-rattle rib. The sensor is located immediately adjacent to the MDI canister when the MDI is stored in the device. The sensor with output data specifies the orientation. A smart system can use the sensor reading to know how much drug remains. An ultrasonic sensor can be used to check the liquid in the MDI canister and an orientation sensor can be used to ensure that readings are taken in a consistent and repeatable position. This allows the user to know when the MDI is out of drug without the need for a dose counter per se.

[0088] With any of the above concepts, the smart holding chamber can use sensor data to determine the cause of an incomplete drug dose. Output to the user can inform the user of technical delays and instruct the user on how to get a good drug dose on the next dose. The user may associate a taste with a dose of drug and know they did not get their dose in the absence of immediate feedback. The system also has an output in the case of a correct dose designed to create a sensation or association in the user that replaces the taste the user would feel if using an MDI alone.

[0089] Asthma attacks may be triggered by environmental influences in certain locations. By recording the locations where the chamber is used and mapping this data over time, high risk locations for exacerbations can be identified, thereby providing asthma patients with a better understanding of their condition. A wireless module that can be coupled to a smart device attached to the VHC can record location data of the smart device during use of the holding chamber. After tracking this data over time, the system can detect patterns of where exacerbations occur. A module that can wirelessly connect to the smart device provided in the smart VHC system can notify the smart device when the MDI is fired in the holding chamber and record the location from the device GPS or cellular signal. Providing the ability to wirelessly pair the MDI with a smartphone allows the two devices to communicate information. Recognizing patterns of exacerbation locations and communicating this information to the user can increase the user's awareness and control of their asthma.

[0090] With reference to FIG. 36, a module attached to the holding chamber that can connect to a world wide network (e.g., cell towers or GPS satellites) can record location data while the holding chamber is in use. After tracking this data over time, the system can detect patterns of where exacerbations occur. A location-tracking capable module provided in a smart holding chamber system can poll for location data when an MDI is fired in the holding chamber. A location tracking component is provided in a smart VHC system. By recognizing patterns of exacerbation locations and communicating this information to the user, the user can be provided with increased awareness and control of their asthma.

[0091] The device acts as a carrying case for the MDI. If a patient is in a hurry, they may carry the device without realizing that the emergency MDI is not housed within the device. People may also forget the case itself. By incorporating wireless functionality within the VHC, the device can connect with the user's phone when it is within range. If the phone is out of range of the device, for example if the user goes out without their VHC, the wireless connection between the VHC and the cellular device is lost. At this point, the cell phone will provide a notification regarding the last known location of the device, informing the user that they have left the device. The system includes a module that is attached to the VHC to be paired with a mobile device and capable of wireless communication. When the connection is lost, the mobile device will display a notification regarding the last known location of the VHC. The ability to wirelessly pair the VHC with a cell phone is provided. By notifying the user when they are not within range of their VHC, the chamber usage can be improved by encouraging the user to carry the VHC and prevent untreated exacerbations when the device is not carried by the user. This helps users to locate their devices if they are lost or misplaced.

[0092] Referring to FIG. 37, wireless capabilities are provided in an attachment that attaches to the MDI to connect with a mobile device. When the phone is out of range of the MDI, wireless communication is lost. At this point, the cell phone provides a notification of the last known location of the MDI, informing the user that the user has left the device. The system includes a wireless communication capable module built into the MDI that pairs with the mobile device and a form-fitting attachment to the MDI that houses the wireless module, such that the attachment does not interfere with the use of the MDI or administration of medication. In the event of a loss of connection, the mobile device displays a notification of the last known location of the MDI. The ability to wirelessly pair the MDI with a cell phone is provided. By notifying the user when they are no longer in range of their holding chamber, untreated exacerbations can be prevented. This helps the user locate their MDI if it is lost or misplaced.

[0093] With reference to FIG. 38, by incorporating a wireless signal transmitter into the VHC, the wireless signal transmitter can interface with a receiving device. In the event that the receiver loses connection with the VHC, the receiver generates a notification or signal that the connection has been lost. By incorporating a method for the user to adjust the signal strength, the radio coverage area where the connection is lost can be adjusted according to preference. The system includes a radio frequency transmitter provided within the VHC, a potentiometer or other interface to adjust the signal strength of the transmitter, and a receiver that can notify the user in the event that the signal between the transmitter and receiver is lost. This helps the user realize that they have forgotten the holding chamber. By providing a potentiometer to adjust the transmitted signal, the user is given control over the maximum distance before being notified. An RF transmitter is provided within the holding chamber along with supporting hardware to allow the user control of the coverage area of ​​the signal. A receiving device must be carried by the user to function properly and to inform the user when they are not within range of the holding chamber where they can prevent an untreated exacerbation. To encourage carrying the receiver, the receiver may be incorporated into a medical alert bracelet, thereby increasing its value to the user.

[0094] Referring to FIG. 39, a limit switch or other simple sensor can be used to determine the presence of an MDI in the holding chamber. A smart system can use this to determine if an MDI is present in the case. A simple sensor positioned in the holding chamber would cause an output value to change if an MDI is present in the case. Sensors include, but are not limited to, limit switches and / or ultrasonic, light or pressure sensors. This system allows the device to notify the user if their puffer is not contained within the VHC. The use of a simple sensor reduces costs compared to more complex reminder systems.

[0095] The data recording / tracking features built into the smart system cannot function properly unless they know that the MDI has been activated.

[0096] By incorporating a sensor or system of sensors into the VHC, the smart system will know when the MDI is activated and aerosol is dispensed into the holding chamber. The sensors provided in the VHC can be any combination of the following devices, allowing the smart system to detect when the MDI is activated while still coupled to the MDI inlet:

[0097] A microphone to detect the acoustic profile of an active MDI canister A pressure sensor to detect an increase in pressure inside the chamber Sensors for detecting propellants or other chemicals in an aerosol plume (including IR drug tracking for dose counting purposes) A force sensor (located on top of the MDI canister or elsewhere near the MDI, possibly in the MDI adapter) Air flow sensor (hot wire MEMS) - Optical sensors that can detect plumes just before they disperse IR / UV Solutions for Drug Detection Gyroscope / accelerometer to keep MDI canister vertically oriented A smart system that can detect when the MDI is activated while still connected to the MDI inlet of the VHC This provides the user with a form of drug detection, technical instruction, or dose counting means to improve the user's asthma and result in better clinical outcomes.

[0098] A smart system is provided that can detect when an MDI is activated while still docked to the MDI inlet of a VHC, thereby providing the user with a form of medication detection, technical instruction, or dose counting means to improve the user's asthma and result in better clinical outcomes.

[0099] Although the present invention has been described with reference to preferred embodiments, those skilled in the art will recognize that changes can be made in form and detail without departing from the spirit and scope of the invention. Therefore, the above detailed description should be considered as illustrative rather than limiting of the present invention, and it is the following claims and all equivalents thereof that define the scope of the present invention.

Claims

1. A holding chamber comprising: a first housing component having a user interface with an exit opening; and a second housing component having an inlet opening spaced from the outlet opening of the first housing component, the first housing component being pivotally connected to the second housing component about a pivot axis, the first housing component and the second housing component being rotatable relative to one another about the pivot axis between a closed configuration in which the first and second housing components define an enclosed interior space and an open configuration in which the first and second housing components define an access opening in communication with the interior space.

2. 2. The holding chamber of claim 1, further comprising a membrane, the membrane movable between a first configuration that closes the entrance opening and a second configuration in which at least a portion of the membrane defines the entrance opening.

3. 3. The holding chamber of claim 2, wherein the membrane has a plurality of flexible sections separated by a plurality of slits, the flexible sections being movable relative to one another when the membrane is moving between the first configuration and the second configuration.

4. 4. The holding chamber of claim 3, wherein the inlet opening defined by the flexible section in the second configuration defines a first area and the slit defines a second area, the second area being smaller than the first area.

5. 4. The holding chamber of claim 3, further comprising relief openings positioned at distal ends of at least some of said slits.

6. The holding chamber of claim 3 , wherein the plurality of flexible segments comprises at least four flexible segments including a pair of end flexible segments that are triangular shaped.

7. The holding chamber of claim 6 , wherein the at least four flexible sections consist of six flexible sections.

8. 8. The holding chamber of claim 7, wherein four of said six flexible segments are disposed between said end flexible segments, said four flexible segments defining a cross-shaped opening therebetween.

9. 2. The holding chamber of claim 1, further comprising an inhalation valve disposed over the outlet opening, the inhalation valve movable between a closed configuration in which the inhalation valve closes the outlet opening and an open configuration in which at least a portion of the inhalation valve is moved away from the outlet opening to permit air flow through the outlet opening during inhalation.

10. 10. The holding chamber of claim 8, further comprising an exhalation valve disposed adjacent to the user interface, the exhalation valve being movable between a closed configuration in which the exhalation valve closes an exhaust outlet communicating the user interface with the ambient environment during inhalation, and an open configuration in which at least a portion of the exhalation valve allows air to flow through the exhaust outlet to the ambient environment during exhalation.

11. The holding chamber of claim 1 , wherein at least one of the first and / or second housing components is translucent or transparent.

12. The holding chamber of claim 11 , wherein at least one of the first and / or second housing components is opaque.

13. The holding chamber of claim 1 , wherein at least one of the first and / or second housing components is luminous.

14. 2. The holding chamber of claim 1, further comprising a cap movably connected to the first housing component, the cap movable between a closed position in which the cap engages the second housing component to hold the first and second housing components in the closed configuration, and an open position in which the cap disengages from the second housing component such that the first and second housing components are pivotable to the open configuration.

15. The holding chamber of claim 14 , wherein the cap further comprises a spring biasing the cap to the open position.

16. The holding chamber of claim 14 , wherein the cap and the first housing component have a releasable locking feature that maintains the cap in the closed position.

17. 2. The holding chamber of claim 1, wherein at least one or both of the first and second housing components have an engagement member disposed within the internal space, the engagement member adapted to engage a drug delivery device disposed within the internal space, the internal space being dimensioned to receive the drug delivery device when the first and second housing components are in the closed configuration.

18. 2. The holding chamber of claim 1, wherein the engagement member comprises a first rib on the first housing component and a second rib on the second housing component, the first and second ribs being shaped and dimensioned to engage the drug delivery device.

19. A holding chamber comprising: a first housing component having a user interface with an outlet opening; a second housing component having an inlet opening spaced from the outlet opening of the first housing component, the first housing component being pivotally connected to the second housing component about a pivot axis, the first housing component and the second housing component being pivotable relative to one another about the pivot axis between a closed configuration in which the first and second housing components define an enclosed interior space and an open configuration in which the first and second housing components are spaced from one another and define an access opening in communication with the interior space; a retention chamber having a cap movably connected to one of the first and second housing components, the cap movable between a closed position in which the cap engages the other of the first and second housing components to maintain the first and second housing components in the closed configuration, and an open position in which the cap disengages from the other of the first and second housing components such that the first and second housing components are pivotable to the open configuration.

20. 20. The holding chamber of claim 19, further comprising a spring biasing the cap to the open position.

21. 20. The holding chamber of claim 19, further comprising a membrane, the membrane movable between a first configuration in which the membrane closes the entrance opening and a second configuration in which the membrane defines the entrance opening.

22. 22. The holding chamber of claim 21, wherein the membrane has a plurality of flexible sections separated by a plurality of slits, the flexible sections being movable relative to one another when the membrane is moving between the first configuration and the second configuration.

23. 23. The holding chamber of claim 22, wherein the inlet opening defined by the flexible section in the second configuration defines a first area and the slit defines a second area, the second area being smaller than the first area.

24. 23. The holding chamber of claim 22, further comprising relief openings positioned at distal ends of at least some of the slits.

25. 23. The holding chamber of claim 22, wherein the plurality of flexible segments comprises at least four flexible segments including a pair of end flexible segments that are triangular shaped.

26. 26. The holding chamber of claim 25, wherein the at least four flexible sections consist of six flexible sections.

27. 27. The holding chamber of claim 26, wherein four of the six flexible segments are disposed between the end flexible segments, the four flexible segments defining a cross-shaped opening therebetween.

28. A sealable backpiece for a holding chamber, comprising: A sealable backpiece having a flexible membrane including a plurality of flexible sections separated from one another by a plurality of slits defining free edges of the flexible sections, the flexible sections being movable relative to one another between a closed configuration in which the free edges of adjacent flexible sections are positioned adjacent to one another and an open configuration in which the flexible sections deform to form an entrance opening, the slits defining only one opening through the flexible membrane in the closed configuration, and the free edges of at least two of the flexible sections are spaced apart from one another and do not intersect each other when the flexible sections are in the closed configuration.

29. 30. The sealable backpiece of claim 28, wherein the entrance opening formed by the flexible section in the open configuration defines a first area and the slit defines a second area, the second area being smaller than the first area.

30. 30. The sealable backpiece of claim 29, further comprising relief openings positioned at distal ends of at least some of the slits.

31. 30. The sealable backpiece of claim 28, wherein the plurality of flexible sections consists of at least four flexible sections including a pair of triangular shaped end flexible sections.

32. 32. The sealable backpiece of claim 31, wherein the at least four flexible sections consist of six flexible sections.

33. 30. The sealable backpiece of claim 28, wherein four of the six flexible sections are disposed between the end flexible sections, the four flexible sections defining a cross-shaped opening therebetween.

34. 1. A method of using a drug delivery system, comprising: moving a first housing component from a closed configuration to an open configuration relative to a second housing component, the first housing component having a user interface with an exit opening and the second housing component having an entrance opening spaced apart from the exit opening of the first housing component; removing a pressurized metered dose inhaler disposed between said first and second housing components through an access opening formed between said first and second housing components in said open configuration; moving the first housing component and the second housing component from the open configuration to the closed configuration, thereby forming a sealed interior chamber; inserting a portion of the inhaler through the inlet opening; Dispensing a medication from the inhaler into the internal chamber defined by the first and second housing components disposed in the closed configuration.

35. 35. The method of claim 34, further comprising the step of moving a cap coupled to one of the first and second housing components from a closed position, wherein the cap engages the other of the first and second housing components thereby preventing movement of the first housing component relative to the second housing component from the closed configuration to the open configuration, and wherein the cap disengages from the other of the first and second housing components.

36. 36. The method of claim 35, further comprising biasing the cap to the open position with a spring.

37. 35. The method of claim 34, wherein the step of inserting a portion of the inhaler through the inlet opening comprises inserting the portion through a sealable membrane, thereby moving the membrane from a first configuration in which the membrane closes the inlet opening to a second configuration in which the portion is inserted through the inlet opening.

38. 36. The method of claim 35, wherein the membrane includes a plurality of flexible sections separated by a plurality of slits, the flexible sections being movable relative to one another when the membrane is moving between the first configuration and the second configuration.

39. 40. The method of claim 38, wherein the entrance opening formed by the flexible section in the second configuration defines a first area and the slit defines a second area, the second area being smaller than the first area.

40. 40. The method of claim 38, further comprising relief openings positioned at distal ends of at least some of the slits.

41. 40. The method of claim 38, wherein the plurality of flexible segments comprises at least four flexible segments including a pair of end flexible segments in the shape of a triangle.

42. 42. The method of claim 41, wherein the at least four flexible segments consist of six flexible segments.

43. 43. The method of claim 42, wherein four of the six flexible segments are disposed between the end flexible segments, the four flexible segments defining a cross-shaped opening therebetween.

44. 35. The method of claim 34, wherein at least one of the first and / or second housing components is translucent or transparent.

45. 45. The method of claim 44, wherein the other of the first and / or second housing components is opaque.

46. 36. The method of claim 35, further comprising maintaining the cap in the closed position with a releasable locking feature.

47. 35. The method of claim 34, further comprising the step of engaging the pressurized metered dose inhaler with an engagement member when the inhaler is disposed between the first housing component and the second housing component in the closed configuration.

48. 48. The method of claim 47, wherein the engagement member has a first rib provided on the first housing component and a second rib provided on the second housing component, and the step of engaging the inhaler includes the step of engaging the inhaler with the first and second ribs.

49. A holding chamber comprising: a housing component having a user interface end portion with an outlet opening and an elliptical valve seat with a peripheral edge; and an intake valve having a central elliptical opening with an inner peripheral edge overlapping the outer peripheral edge of the valve seat, the intake valve being movable between an intake configuration in which at least a portion of the inner peripheral edge is spaced from the outer peripheral edge and an exhalation configuration in which the inner peripheral edge engages the outer peripheral edge.

50. 50. The holding chamber of claim 49, wherein the valve seat includes a first valve seat, the end portion further includes a second valve seat, and the intake valve further has an outer circumferential edge overlapping the second valve seat, the outer circumferential edge being movable between an exhalation configuration in which at least a portion of the outer circumferential edge is spaced from the second valve seat, and an intake configuration in which the outer circumferential edge engages the second valve seat.

51. 51. The holding chamber of claim 50, wherein the outer perimeter comprises a pair of spaced apart flaps.

52. 51. The holding chamber of claim 50, wherein the intake valve has a base portion disposed between the inner periphery and the outer periphery, the base portion being clamped between first and second components of the end portion.

53. The holding chamber of claim 1 , wherein said inlet opening and said outlet opening are perpendicular to a longitudinal axis when said first and second housing components are in said closed configuration.

54. The holding chamber of claim 1 , wherein the inlet opening and the outlet opening are substantially aligned along a longitudinal axis when the first and second housing components are in the closed configuration.

55. 20. The holding chamber of claim 19, wherein the inlet opening and the outlet opening are perpendicular to a longitudinal axis when the first and second housing components are in the closed configuration.

56. 20. The holding chamber of claim 19, wherein the inlet opening and the outlet opening are substantially aligned along a longitudinal axis when the first and second housing components are in the closed configuration.

57. A holding chamber comprising: a first housing component having a user interface with an outlet opening; a second housing component having an inlet opening spaced from the outlet opening of the first housing component, the first housing component being pivotally connected to the second housing component about a pivot axis, the first housing component and the second housing component being pivotable relative to one another about the pivot axis between a closed configuration and an open configuration; a first latch movable between a latched configuration in which the first latch secures the first and second housing components in the closed configuration and an unlatched configuration in which the first and second housing components can move to the open configuration; a cap movably connected to one of the first and second housing components, the cap movable between a closed position in which the cap engages the other of the first and second housing components to maintain the first and second housing components in the closed configuration, and an open position in which the first and second housing components are pivotable to the open configuration; a retention chamber having a second latch movable between a latched configuration in which the second latch secures the cap to the other of the first and second housing components in the closed position and an unlatched configuration in which the cap can be moved to the open position, the first latch being movable from the latched configuration to the unlatched configuration only when the second latch is in the unlatched configuration.

58. 58. A drug delivery device having the holding chamber of any one of claims 1 to 27 and claims 49 to 57, further comprising a pressurized metered dose inhaler having a drug contained within the interior space, said pressurized metered dose inhaler engaging said holding chamber when said first and second housing components are in said closed configuration, said pressurized metered dose inhaler being movable through said access opening when said first and second housing components are in said open configuration, and at least a portion of said pressurized metered dose inhaler being insertable through said inlet opening of said second housing component.

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