INHALER

Abstract

A device for inhaling an active agent is provided that can be moved from a first configuration to a second configuration. The device comprises two flexible substrates and a membrane located between the two flexible substrates, and the two flexible substrates being connected at two opposing edges and unconnected at two further opposing edges. An active agent provided on the membrane may be inhaled by a user when the device is in the second configuration.

Claims

1. An inhaler, comprising: two flexible substrates connected at first two opposing edges that extend along a length of the two flexible substrates and unconnected at second two opposing edges that meet the first two opposing edges such that the two flexible substrates are movable between a first configuration where the two flexible substrates are substantially flat and in contact with one another and a second configuration where the two flexible substrates are flexed such that a channel forms between the two flexible substrates, extends along the length thereof, and opens at the second two opposing edges; and a membrane located between the two flexible substrates and configured to span the channel between the two flexible substrates when the inhaler is in the second configuration, such that an active agent disposed on the inhaler may be inhaled by a user when the inhaler is in the second configuration.

2. The inhaler according to claim 1, wherein the two flexible substrates are one of rectangular, square, or oblong.

3. The inhaler according to claim 1, wherein the two flexible substrates are biodegradable.

4. The inhaler according to claim 1, wherein the two flexible substrates are card sheets, card sheets coated with a plastic, or plastic.

5. The inhaler according to claim 1, wherein at least a portion of one or both of the two flexible substrates comprises a metallic coating.

6. The inhaler according to claim 1, wherein a cross-section of the channel is reduced in a portion of the channel.

7. The inhaler according to claim 1, wherein a cross-section of the channel is reduced in the channel at at least one of the second two opposing edges.

8. The inhaler according to claim 1, further comprising a seal on at least one side of the membrane.

9. The inhaler according to claim 8, wherein the seal is adjacent to a first opening and a second opening of the channel.

10. The inhaler according to claim 1, wherein at least one of the two flexible substrates comprise a reinforcing element.

11. The inhaler according to claim 10, wherein the reinforcing element is adjacent to at least one of a first opening or a second opening of the channel.

12. The inhaler according to claim 10, wherein the reinforcing element is a strip of material that is stiffer than the two flexible substrates.

13. The inhaler according to claim 1, wherein the membrane is a mesh.

14. The inhaler according to claim 1, wherein the membrane is air permeable.

15. The inhaler according to claim 1, wherein the membrane is mounted to both of the two flexible substrates.

16. The inhaler according to claim 1, wherein the membrane spans the channel.

17. The inhaler according to claim 1, wherein the membrane is flexible and is one of folded or collapsed when the inhaler is in the first configuration.

18. The inhaler according to claim 1, wherein the active agent is present on the membrane.

19. The inhaler according to claim 18, wherein the active agent is in particulate form.

20. The inhaler according to claim 18, wherein the active agent is an inhalable active agent selected from the group consisting of tramadol, gabapentin, Vicodin (registered trade mark), ibuprofen, acetaminophen, hydrocodone, naproxen, methadone, codeine, hydroxyzine, paracetamol, aspirin, insulin, canagliflozin, alogliptin benzoate, dapaglifozin, empagliflozin, ranibizumab, duglaglutide, pioglitazone hydrochloride, glimepiride, oxytocin, and sildenafil.

Description

BRIEF DESCRIPTION OF THE FIGURES

[0068] Embodiments of the present invention will now be described, by way of non-limiting example, with reference to the accompanying drawings.

[0069] FIG. 1 shows a front perspective view of a device according to an embodiment of the invention in the closed or first configuration;

[0070] FIG. 2 shows a front perspective view of a device according to an embodiment of the invention in the open or second configuration;

[0071] FIG. 3 is a front view of a device according to an embodiment of the invention in the first configuration showing a user applying pressure to sides of the device;

[0072] FIG. 4 is a front view of a device according to an embodiment of the invention showing the device in the open second configuration after pressure has been applied to the sides of the device.

[0073] FIG. 5 shows a device according to an embodiment of the invention in the second open configuration;

[0074] FIG. 6 shows a device according to an embodiment of the invention in the second open configuration;

[0075] FIG. 7 shows a front perspective view of a device according to an embodiment of the invention;

[0076] FIG. 8 shows a front perspective view of a device according to an embodiment of the invention;

[0077] FIG. 9 shows a front perspective view of a device according to an embodiment of the invention;

[0078] FIG. 10 is a plan view of a device according to an embodiment in (A) the closed first configuration and (B) in the open second configuration;

[0079] FIG. 11 is a front perspective view of an embodiment of the invention;

[0080] FIG. 12 is a front view of the device of FIG. 11;

[0081] FIG. 13 is a schematic of the air flow through the device of FIG. 10 in the open second configuration;

[0082] FIG. 14 is plan views of a device according to an embodiment of the invention in (A) the closed first configuration and (B) in the open second configuration;

[0083] FIG. 15 is a plan view of a device according to an embodiment;

[0084] FIGS. 16(A) and (B) shows plan views of two devices showing different configurations of foil envelopes protecting the membrane in the first configuration;

[0085] FIG. 17(A) is a front view of a device according to an embodiment where the membrane is mounted in a support, and (B) shows an exploded view of the membrane and support; and

[0086] FIG. 18 is a front perspective view of a device according to an embodiment comprising a membrane mounted in a support.

DETAILED DESCRIPTION

[0087] While the making and using of various embodiments of the present invention are discussed in detail below, it should be appreciated that the present invention provides many applicable inventive concepts that can be embodied in a wide variety of specific contexts. The specific embodiments discussed herein are merely illustrative of specific ways to make and use the invention and do not delimit the scope of the invention.

[0088] To facilitate the understanding of this invention, a number of terms are defined below. Terms defined herein have meanings as commonly understood by a person of ordinary skill in the areas relevant to the present invention. Terms such as “a”, “an” and “the” are not intended to refer to only a singular entity, but include the general class of which a specific example may be used for illustration. The terminology herein is used to describe specific embodiments of the invention, but their usage does not delimit the invention, except as outlined in the claims.

[0089] With reference to FIGS. 1-7, an inhaler 1 comprises two rectangular card sheets 2 (acting as flexible substrates) and a mesh 4 (acting as a membrane). The two card sheets are connected at two opposing edges 6 such that the two card sheets occlude one another and have interior surfaces 8 and exterior surfaces 10. The mesh is connected to the interior surface of both card sheets. A particulate form of salbutamol 12 (corresponding to an active agent) is provided on the mesh.

[0090] The inhaler is configured to move between two configurations, a closed configuration as shown in FIG. 1 (corresponding to the first configuration) and an open configuration as shown in FIG. 2 (corresponding to the second configuration). In the closed configuration, the interior surfaces of the two card sheets are adjacent and the inhaler is flat. In the open configuration, a channel 16 is formed between the two card sheets and the mesh spans the channel. The channel has a first opening 18 and a second opening 20 and air flowing from the first opening to the second opening passes through the mesh to thereby lift the particles of salbutamol from the mesh.

[0091] The inhaler is retained before use in a sealed water proof envelope to ensure that the salbutamol on the mesh does not come into contact with water.

[0092] When the inhaler is to be used, the inhaler is removed from the water proof envelope. The user pinches the two sides of the inhaler that are connected together to move the inhaler from the closed configuration to the open configuration (see FIGS. 3 and 4). The inhaler is then brought into contact with the user's mouth to thereby form a seal around the second opening of the channel and the user inhales through the channel of the inhaler. Salbutamol particles are thereby lifted from the mesh and are drawn into the lungs of the user. The inhaler may then be discarded.

[0093] In an alternative embodiment, with reference to FIG. 8, seals 102, 104 are provided between the interior surfaces of the two card sheets to thereby seal the mesh and the salbutamol retained thereon from moisture. Accordingly, it is not necessary to retain the inhaler of this embodiment in a sealed waterproof envelope. Instead, when the user needs to receive a dose of salbutamol, the seals are broken and the mesh exposed when the user squeezes the sides of the inhaler to move the inhaler from the closed configuration to the open configuration.

[0094] With reference to FIG. 14 in an alternative embodiment, a membrane 106 in a device is protected from moisture, light, and contamination by a foil lining 108 (acting as a metallic coating) on the interior of the channel. The foil lining is bounded at either side of the membrane by a seal 110, 112 such that the membrane is sealed within a foil envelope formed by the foil lining 108 of both interior surfaces of the channel. The foil envelope extends either side of the membrane (FIG. 14A or 14B). In one example, the foil envelope extends across a portion of the channel (FIG. 14A). In a second example, the foil envelope extends substantially along the entire length of the channel (FIG. 14B).

[0095] When the device is moved from the first configuration to the second configuration, the seals 110, 112 are broken and the membrane 106 is exposed for use.

[0096] In a further alternative embodiment, with reference to FIG. 9, the two card sheets comprise two reinforcing strips 106, 108 (corresponding to reinforcing elements). Each reinforcing strip is curved such that the device is biased towards the open configuration. Each reinforcing strip extends across one card sheet from one connected edge to the second connected edge. Accordingly, the reinforcing strips run across the channel when the inhaler is in the open configuration. When the inhaler is squeezed or compressed to move the inhaler from the closed configuration to an open configuration the user grips the device adjacent to the reinforcing strips and compresses the card sheets at the reinforcing strips.

[0097] Accordingly, the reinforcing strips assist the user to open the device by moving the device from the closed configuration to the open configuration.

[0098] In a yet further embodiment, the two card sheets comprise creases (not shown) acting as flexible regions that bias the device towards the open configuration. Accordingly, the device may more readily open when pressure is applied to the connected opposing edges by the user.

[0099] In another embodiment, the mesh comprises particles that comprise an inhalable form of insulin as the active agent.

[0100] With reference to FIGS. 10 to 13, in an alternative embodiment, a device 200 comprises two plastic coated card sheets 202, a membrane 204 mounted within a support 206 within a channel 206 formed between the two sheets 202. The two sheets 202 comprise cuts 208 and creases 210, and are bonded to each other along two opposed edges 212, and are unconnected along two other opposed edges 214.

[0101] In a first configuration (shown in FIG. 10A) the two sheets 202 are flat and rectangular. In a second configuration (shown in FIG. 10B) the channel opens between the two sheets and the membrane 216 and support 218 unfold to span the channel. When the device is moved from the first configuration to the second configuration the user presses the sides adjacent to the cuts and creases as indicated by the arrows in FIG. 10A. As a result, the part of the flexible substrate between the cut and crease folds into the channel, thereby forming an aperture within the channel and changing the shape of the channel to form the second configuration as shown in FIG. 10B. The support 218 and membrane 216 span and occlude the aperture such that airflow 220 (represented by the arrows in FIG. 13) through the device is forced to pass through the membrane.

[0102] With reference to FIG. 13, air entering the device through the air inlet is moving at a given flow rate. As the cross-section of the channel narrows, the air is forced to accelerate to maintain the same flow rate. Accordingly, the air is forced to accelerate through the aperture and membrane, thereby applying a higher force on the active agent on the membrane to lift that active agent into the airflow from the membrane.

[0103] A variation of the device shown in FIG. 10 is shown in 3D in FIGS. 11 and 12. The device further comprises supports 222 at the air outlet that 224. The supports 222 brace the air outlet to resist excessive force being applied to the device by the mouth of the user. The front view of the device shown in FIG. 12 does not show the membrane of the device to allow the channel to be seen in full.

[0104] A similar effect may be achieved by devices with channels that narrow to an aperture such as those shown in FIGS. 14 and 15. For example, FIG. 14A shows a device where the flexible sheets comprise creases 302. When the device is moved from the first configuration to the second configuration, the device is squeezed by the user as indicated by the arrows in FIG. 14A such that the width of the air outlet 304 is reduced.

[0105] A membrane 402 mounted in a support 404 is shown in FIG. 17A. The membrane 402 is sandwiched between two support layers 406, 408 and occludes an aperture 410, 412 in the two support layers 406, 408. The two support layers 406, 408 are typically bonded together with a bonding agent such as glue or similar.

[0106] It will be appreciated by the person skilled in the art that the above embodiments are examples and that the features of each disclosed embodiment may be combined with the features of other embodiments. Further variations and modifications are herein contemplated and included in the present invention.