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Title:
DRY POWDER INHALATION DEVICE
Document Type and Number:
WIPO Patent Application WO/2017/079397
Kind Code:
A1
Abstract:
Disclosed herein is a device for the delivery of a dry powdered or aerosolized substance (e.g., medication) to a user via inhalation. Delivery of the dry powdered substance is performed using an inhalation device having an inhalation tube and a hollow extension housing an assembly of components including an impeller, a puncturing device and a dry powder container. The inhalation tube, extension and assembly are configured such that a user inhaling a breath from an end of the inhalation device creates a negative pressure on the container of dry powdered substance thereby drawing the dry powdered substance from the container into the user's lungs. The delivery of the dry powder through the inhalation device is facilitated by the puncturing device that punctures the dry powder container, the impeller that directs the flow of air and the particular configuration of the extension and the inhalation tube.

Inventors:
YADIDI KAMBIZ (US)
Application Number:
PCT/US2016/060268
Publication Date:
May 11, 2017
Filing Date:
November 03, 2016
Export Citation:
Click for automatic bibliography generation   Help
Assignee:
OTITOPIC INC (US)
International Classes:
A61K9/00; A61K9/14; A61K9/72; A61M15/00; A61M15/06
Domestic Patent References:
WO1997012639A11997-04-10
WO1998058695A11998-12-30
Foreign References:
CN204501970U2015-07-29
US20070151562A12007-07-05
DE102009041664A12011-03-24
US5655523A1997-08-12
CN204208146U2015-03-18
Attorney, Agent or Firm:
GABATHULER, Henry et al. (US)
Download PDF:
Claims:
What is claimed is:

1. A dry powder inhalation device comprising:

an inhaler body, the inhaler body including an

inhalation tube, and

an extension positioned on at a surface of the inhalation tube, wherein the extension comprises one or more sidewalls extending between a first end and an open second end and surrounding an interior volume, the extension being sized and shaped to receive an assembly therein, wherein one or more of the extension and the inhalation tube are formed to define at least one opening that joins the interior volume of the extension and an interior volume of the inhalation tube; and

the assembly positioned within the interior volume of the extension, the assembly comprising:

an impeller,

a puncturing device, and

a dry powder container that contains a measured amount of dry powder.

2. The dry powder inhalation device of claim 1, further comprising:

a cap configured to fit over an open end of the extension thereby securing the assembly within the extension, wherein the impeller is positioned proximate to the first end of the extension and the dry powder container is positioned proximate to an opposing open second end and wherein the puncturing device is positioned between the impeller and the dry powder container.

3. The dry powder inhalation device of claim 1, wherein the impeller is configured to rotate about a central axis upon application of negative pressure to a first end of the inhalation tube by a user inhaling through the inhalation tube.

4. The dry powder inhalation device of claim 3, wherein the impeller includes a series of blades and openings arranged to direct air and the dry powder into the interior volume of the inhalation tube.

5. The dry powder inhalation device of claim 3, wherein the first end of the inhalation tube has a smaller internal diameter than an internal diameter of a second opposing end of the inhalation tube.

6. The dry powder inhalation device of claim 1 , wherein the inhalation tube has a shape that is one or more of curved and straight.

New Claims:

7. The dry powder inhalation device of claim 1, the impeller comprising a series of blades and openings and having a top surface and an opposing bottom surface, wherein the impeller is disposed within the interior volume of the extension such that the bottom surface faces the at least one opening, and wherein the impeller is configured to rotate about a central axis and direct airflow from the interior volume of the extension toward the interior volume of the inhalation tube.

8. The dry powder inhalation device of claim 8, wherein the impeller includes a central axis pin and rotates around the central axis pin, and wherein the impeller is supported within the a extension by one or more mounts that are configured to receive a respective end of the central axis pin.

9. The dry powder inhalation device of claim 9, further comprising:

a bottom structure provided at the first end of the extension opposite the open second end, wherein the bottom structure all is formed to include at least one opening joining the respective interior volumes of the extension and the inhalation tube.

wherein a first mount among the one or more mounts is provided on the bottom structure and configured to receive a bottom end of the central axis pin therein, and wherein a second mount is provided on a bottom side of the puncturing device and is configured to receive a top end of the central axis pin therein.

10. The dry powder inhalation device of claim 7, wherein the impeller is supported within an impeller body that has a top side and a bottom side that are both formed to define one or more air passages therethrough and wherein the impeller body is configured to support the impeller therein such that the impeller is rotatable about the central axis.

11. The dry powder inhalation device of claim 10, and wherein the top side of the impeller body and the puncturing device are integrally formed.

12. The dry powder inhalation device of claim 7, wherein the one or more sidewalls are formed to define orifices therethrough thereby allowing airflow through the one or more sidewalls into the interior volume of the extension.

13. The dry powder inhalation device of claim 12, wherein at least the impeller of the assembly is positioned within the interior volume of the extension at a level that is between one or more of the orifices and the first end of the extension.

14. The dry powder inhalation device of claim 13, wherein the puncturing device is positioned within the interior volume of the extension at a level that is above a top side of the impeller and below one or more of the orifices.

15. The dry powder inhalation device of claim 14, wherein the puncturing device comprises:

a body that is formed to include one or more openings extending through a thickness of the puncturing device body:

one or more extensions that extend from a top surface of the puncturing device body in a direction of the open end of the extension, wherein a distal end of the one or more extensions are configured to puncture an opposing bottom lid of the dry powder container when pressed against the one or more extensions, and wherein the one or more openings of the puncturing device body are configured to allow the dry powder to pass therethrough.

16. The dry powder inhalation device of claim 1, wherein the dry powder container further comprises:

a cup that is shaped to contain the dry powder within an interior of the cup and having an open end, and

a bottom lid covering the open end of the cup and configured to seal the dry powder within the interior space of the cup, and wherein the bottom lid is puncturable by the puncturing device.

17. The dry powder inhalation device of claim 16, wherein the dry powder container is configured to expel the dry powder out of the interior space when the bottom lid is punctured by puncturing device.

18. The dry powder inhalation device of claim 1, wherein the extension further comprises at least one locating features provided on an interior surface of the one or more sidewalls, wherein the at least one locating feature is shaped to engage at least one complementary locating features provided at an exterior surface of one or more of the impeller, the puncturing device, and the dry powder container.

Description:
DRY POWDER INHALATION DEVICE

FIELD OF THE INVENTION

The present invention relates to dry powder inhalation devices for the dispensing of dry powders and medication into the mouth of a user. BACKGROUND

Pulmonary delivery of therapeutic agents offers several advantages over other modes of delivery. These advantages include rapid onset, the convenience of patient self administration, the potential for reduced drug side-effects, ease of delivery by inhalation, the elimination of needles, and the like. Inhalation therapy is capable of providing a drug delivery system that is easy to use in an inpatient or outpatient setting, results in very rapid onset of drug action, and produces minimal side effects. In addition, dry powder inhalation offers the possibility of delivering accurate and reproducible doses of a drug to the pulmonary vasculature. BRIEF DESCRIPTION OF THE DRAWINGS

The present invention is illustrated by way of example, and not limitation, in the figures of the accompanying drawings, in which:

Figures 1A and IB depict exploded views of an exemplary dry powder inhaler in accordance with some embodiments of the present invention;

Figures 1C and ID depict assembled views of components of the exemplary dry powder inhaler in accordance with some embodiments of the present invention;

Figures 2A-2C provide various views of an inhaler body in accordance with some embodiments of the present invention;

Figures 3A-3C provide various views of an impeller in accordance with some embodiments of the present invention;

Figures 4A-4D provide various views of a puncturing device in accordance with some embodiments of the present invention;

Figures 5A and 5B provide various views of a dry powder container in accordance with some embodiments of the present invention;

Figures 6A and 6B provide various views of a cap in accordance with some embodiments of the present invention;

Figures 7A-7C provide exploded views of an alternate exemplary inhalation device in accordance with some embodiments of the present invention;

Figures 8 A and 8B provide various views of a cover in accordance with some embodiments of the present invention;

Figures 9A-9D provide various views of an inhalation tube assembly in accordance with some embodiments of the present invention;

Figure 10A and 10B provide various views of an assembled inhalation device in accordance with some embodiments of the present invention; Figure 11A and 11B provide various views of an assembled inhalation device in accordance with some embodiments of the present invention;

Figures 12A and 12B provide various views of another exemplary inhalation device in accordance with some embodiments of the present invention;

Figures 13A-13C provide various views of a right angle inhalation tube assembly in accordance with some embodiments of the present invention;

Figures 14A and 14B provide various views of an assembled dry powder inhaler in accordance with some embodiments of the present invention; and

Figure 15 is a schematic view of a patient using a dry powder inhaler in accordance with some embodiments of the present invention.

DETAILED DESCRIPTION

Disclosed herein is a device for the delivery of a dry powdered or aerosolized substance (typically a medication) to a user via inhalation. In some embodiments, delivery of the dry powdered or aerosolized substance may be enabled by an inhalation device configured such that a user inhaling a breath from an end of the inhalation device (e.g., placing their mouth over the end and drawing air through the inhalation device) creates a negative pressure on a capsule containing the dry powdered substance thereby drawing the dry powdered substance from the capsule into the mouth and/or lungs of the user via the dry powder inhalation device (also referred to as the inhalation device or inhaler device).

In one embodiment, the inhalation device disclosed herein may be used to deliver dry powdered or aerosolized respirable dry powders that comprise, for example and without limitation, an NSAID, such as acetyls alicylic acid, as the active ingredient. The respirable dry particles may vary in size, e.g., a geometric diameter (VMGD) between 0.5 μιη and 30 μιη. Alternatively, the respirable dry powders can have a mass median aerodynamic diameter (MMAD) of about 20 μηι or less. Optionally, the MMAD of the particles may be between 0.5 and 10 μιη or between 1 and 10 μιη. Exemplary dry powder compositions that can be administered using a dry powder inhalation device in accordance with the disclosed embodiments are further described in U. S. Provisional Application Serial No. 62/251,240, titled DRY POWDER INHALATION DEVICE and filed on November 5, 2015, which is hereby incorporated by reference as if disclosed in its entirety herein.

Figures 1A and IB depict exploded views from various perspectives of an exemplary dry powder inhaler 100 for use with a dry powder in accordance with one or more of the exemplary embodiments. More specifically, Figure 1A illustrates an exploded view of an exemplary dry powder inhaler 100 from a top to bottom perspective and Figure IB illustrates an exploded view of an exemplary dry powder inhaler 100 from a bottom to top perspective.

As shown, the dry powder inhaler 100 includes an inhaler body 105 with an inhalation tube 110 and an extension 115. Extension 115 is sized and positioned to extend from an outer surface of the inhalation tube 110 such that an assembly of an impeller 120, a puncturing device 125, and a dry powder container 130 can be positioned therein. In addition, a cap 135 may be positioned on top of the extension 115 so as to, for example, secure the assembly of the impeller 120, the puncturing device 125, and the dry powder container 130 within the extension 115. In one embodiment, all of the components of the assembly (i.e., the impeller 120, the puncturing device 125, and the dry powder container 130) can be circular in shape and sized so as to fit together with one another and within the extension 115. Figure 1C depicts a side view of the components (impeller 120, puncturing device 125 and dry powder container 130) in an assembled state and Figure ID depicts a cut-away view of the assembly disposed within the extension 115, in accordance with some embodiments of the present invention.

Exemplary dimensions for the components of dry powder inhaler 100 are as follows: • inhalation tube 110: 70-76 mm in length

• extension 115: 18-21 mm in length

• impeller 120: 16-18 mm in diameter

• puncturing device 125: 16-18 mm in diameter

• dry powder container 130: 16-18 mm in diameter

It will be appreciated by those of skill in the art that the shapes of the dry powder inhaler 100 and/or the components thereof (e.g., inhaler body 105, inhalation tube 110, extension 115, impeller 120, puncturing device 125, and/or dry powder container 130) may be any appropriate shape or size. For example, the shape of dry powder inhaler 100 and/or the components thereof may be circular, oval, square, triangular, octagonal, or rectangular in shape or may be a combination of shapes. For instance, an inhalation tube 110 having a square cross-section can be provided along with a circular extension 115 that is sized and shaped to accommodate a circular impeller 120, an octagonal puncturing device 125, and a square dry powder container 130 therein.

Figures 2A-2C provide various views of the exemplary inhaler body 105. More specifically, Figure 2 A is a top perspective view of the inhaler body 105 showing that a first end 205 of inhalation tube 110 that has a smaller interior diameter than a second end 210 of inhalation tube 110, which has a larger interior diameter than the first end 205. The side walls defining the tube-shaped inhalation tube 110 surround an interior volume 218. The diameter and relative size of the two open ends of the inhalation tube 110 and generally hollow configuration can be sized and shaped to facilitate the flow of air and dry powder through the interior volume of the inhalation tube when a user draws a breath from the first end 205. As shown, the inhalation tube is generally tube-shaped and extends primarily in a horizontal direction 212. The extension 115 can be a generally hollow structure that extends from an outer side or surface of the inhalation body. For instance, the extension 115 can comprise one or more sidewalls that extend in a vertical direction 214 between a first end 222 that is located at a top side of the inhalation tube 110 and an open second end 224. In addition, the walls of the extension surround a generally open interior space or volume 216. In some instances, the extension can be at least partially defined by a portion of the inhalation body 105 that extends away from the main lengthwise oriented portion of the inhalation body 105. Accordingly, the extension can be comprised of a single continuous structure or one or more individual components that are fixedly or removably joined to define the extension 115.

Preferably, the extension 115 is sized and configured so as to accept the assembly of the impeller 120, the puncturing device 125, and the dry powder container 130 within the interior volume of the extension thereby housing at least a portion of the assembly. In some cases, the extension 115 may include one or more locating features, such as notches, protrusions or other mechanical mechanisms for accommodating insertion, placement and/or retention of a component of the assembly of the impeller 120, the puncturing device 125, and the dry powder container 130 in the extension 115. Accordingly, the components of the assembly can also include one or more locating features that are provided on an outer surface of the component and that have a complementary shape so as to matingly engage with the locating features provided at the interior surface of the extension 115. For instance, the locating feature can be a protrusion from the interior wall of the extension that is sized and shaped to engage a complementary notch that is provided in an outer edge of the puncturing device so as to retain the puncturing device at a suitable level and orientation within the interior of the extension. By way of further example, the locating feature can be a ridge that extends around the interior surface of the extension at a given level and that has a smaller diameter than the dry powder container so as to prevent the dry powder container from being inserted too deep within the extension.

The cap 135 may be sized so as to fit on top of the extension 115 and thereby can secure the assembly of the impeller 120, the puncturing device 125, and the dry powder container 130 within the extension 115 during use and/or storage. In addition, as further described herein, the cap can also be configured to facilitate the use of the inhalation device.

In some embodiments, the sidewall of extension 115 can include one or more openings 215 that extend through the thickness of the sidewall. The openings 215 can serve to facilitate air flow through the dry powder inhalation device 100 and, in some instances, may act as windows so that a user may visually confirm the placement of one or more dry powder inhalation device 100 components positioned therein. More specifically, the one or more openings 215 facilitate air flow from outside of the extension into the interior volume of the extension.

The openings can be located at various levels within the extension so as to facilitate the flow of air through one or more components of the assembly. For instance, as shown in FIG. 2C, preferably, one or more lower side openings 215D are provided through the side wall of the extension at a level that is above the bottom-most first end of the extension (in the vertical direction 214). The lower side opening 215D can also be provided at a level that is below one or more components of the assembly housed within the extension 215, for instance, the impeller (not shown). Accordingly, in the inflow of air through lower side opening 217 from below the impeller can facilitate the flow of air and dry powder from the interior volume of the extension into the interior volume of the inhalation tube as further described herein. Similarly, as shown in FIG. 2C, upper side openings 215 A-C, can be provided at a level that is above one or more of the assembly components housed within the extension 215. For instance, the upper side openings 215A-C can be provided at a level that is above the impeller (not shown) and that is below the bottom lid of the dry powder container when assembled for use. Accordingly, in the inflow of air through upper side openings 215A-C can facilitate the evacuation of dry powder from the dry powder container and can facilitate the flow of air and/or dry powder through the impeller toward the interior volume of the inhalation tube, as further described herein.

Figure 2B provides a top plan view of the inhaler body 105 and depicts a bottom structure or "wall" of the extension 115. In this exemplary implementation, the bottom includes a grid 220 of openings therethrough and is configured to allow passage of air as well as a dry powder therethrough. Although the bottom including the grid 220 are described as being a part of the extension 115, the bottom can similarly be defined by a portion of the inhalation tube that is bounded by the extension 115. For instance, a portion of the top wall of the inhalation tube 110 can be cut to define the grid openings and the extension 115 can be provided around the so defined grid 220. Similarly, in the case where the extension 115 is at least partially defined by a vertically oriented extension of the inhalation tube 110, the bottom can be provided across such an extension. Moreover, although the structure including the grid 220 is described as being a "bottom" structure or wall of the extension, the structure need not be located at the bottom- most first end 222 of the extension 115. For instance, the structure including the grid 220 can be disposed at a level within the interior volume of the extension that is set above the first end in the vertical direction 214.

As shown in FIG. 2B, the bottom of extension 115 can also have a center opening 225 into which an axis pin of impeller 120 may be inserted. Grid 220 may include a plurality of openings of any appropriate size that may be arranged in any appropriate manner. For example, in Figure 2B, grid 220 comprises a series of semi-circular openings concentrically radiating outwardly from center opening 225 with six solid support structures 230 extending outwardly from the center opening 225 toward the interior surface of extension 115. In other embodiments, grid 220 may comprise a mesh structure provided at or near the bottom end of the extension 115 so as to prevent particles of dry powder and/or a portion of dry powder container 130 having a diameter greater than the mesh from passing through the mesh and entering the interior volume 218 of the inhalation tube 110. In some embodiments, the bottom wall can comprise one or more support structures and one or more openings that allow passage of air and dry powder from the interior of the extension into the interior of the inhalation tube. In addition or alternatively embodiments, a bottom structure can be omitted so as to provide an unobstructed opening allowing air and/or dry powder to pass more freely between the interior volume of the extension 216 and the interior volume of the inhalation tube 218.

Figure 2C provides a side plan view of the second side of inhaler body 105, which shows the relative diameter of the first end of inhalation tube 205 compared to the larger diameter of the second end of inhalation tube 210. The difference in diameter between the first and second end, as well as the cross-sectional profile the inhalation tube extending between the two ends can be varied so as to improve the flow of air when a negative pressure is applied to the first end.

Figures 3A-3C depict various views of an exemplary impeller 120 in accordance with one or more of the disclosed embodiments. Figure 3A provides a top plan view of impeller 120, Figure 3B shows a side view of impeller 120, and Figure 3C shows a side perspective view of impeller 120.

As can be seen in Figures 3A-3C, the exemplary impeller 120 can include an axis pin 305, multiple blades 310, multiple openings 315 between the blades and an outer edge 320. The impeller also has a top side 312 and a bottom side 314. Preferably, for use, the impeller is disposed within the interior volume of the extension 115 such that the bottom side 314 of the impeller is facing downwards in the vertical direction 214 (e.g., toward the interior volume of the inhalation tube 218).

In some embodiments the axis pin 305 can extend along the central axis of rotation of the impeller. For instance, as shown in FIG. 3B, a bottom axis pin 305 A can extend from the bottom side of the impeller. The bottom end of the axis pin 305A can be sized and shaped to correspond with a complementary mount that is provided within the extension 115. For instance, as shown in FIG. 2B, the mount can be a center opening 225 that is formed in the center of the bottom wall of the extension 115 so as to receive the bottom axis pin 305 A therein. Accordingly, the impeller can freely rotate in a circular/rotational direction about the axis pin. In some implementations, the axis pin can be configured to rotate within the mount. In another exemplary configuration the axis pin can extend through the center of the impeller and the impeller can be configured to rotate about the central axis pin, for instance, using bearing assembly sealed within the impeller and surrounding the central axis pin. As shown in FIG. 3B, the impeller 120 can also include a top axis pin 305B that extends from the top side 312 of the impeller. In such a configuration, the top end of axis pin 305B can be received by a corresponding mount that is provided above the top side of the impeller and that retains the impeller in position from above. For instance, a mount or center opening (e.g., 415 of FIG. 4B) can be formed in the center of the bottom side of the puncturing device 120 and configured to receive the top end of axis pin 305A therein similar to the exemplary bottom mount.

Alternative mounting configurations can be implemented to support the impeller so as to allow the impeller to rotate without departing from the scope of the disclosed embodiments. For instance, in another exemplary configuration, the impeller can be supported within an impeller housing (not shown) such that the impeller can rotate freely within the housing. In such an exemplary configuration, the housing can include one or more mounts provided near the central axis of the impeller, as described previously. In addition or alternatively, the impeller can be rotatably supported at or near its outer edge 320, for instance by one or more bearing assemblies supporting the impeller from below and/or above the outer edge of the impeller. Preferably, in such a configuration, the impeller housing can include openings in both a top and bottom end of the housing allowing air and/or dry powder to pass of the housing and the impeller.

Impeller 120 may have a number of blades 310 (e.g., 6, 8, 10, etc.) provided in a variety of different patterns. Each blade can be adjacent to a corresponding opening 315. The impeller and the blades can be positioned such that, when a user applies a negative pressure to the first end of the inhalation body 105 (for example, by the user inhaling through the first end 205) and draws air through the inhalation tube, a force is applied to the impeller 120 causing the impeller to rotates about a central axis. Accordingly, blade 310 may further act to move air and/or dry powder through openings 315 and direct the air and/or dry powder toward the interior volume of the inhalation tube. In some embodiments, the impeller 120 aerosolizes the dry powder to facilitate the evacuation of the dry powder from the dry powder container 130 and further directs it through the inhalation tube 110 toward the first end 105. It should be understood that a variety of impeller and/or propeller designs can be implemented to assist the flow of air and dry powder through the interior volume of the inhalation device during use without departing from the scope of the exemplary embodiments.

Figures 4A-4D show various views of puncturing device 125. In the exemplary configuration shown, puncturing device 125 can be circular in shape and can include a plurality of blades 405 and/or circular extensions 410 and a center opening 415.

As previously noted, center opening 415 of the puncturing device 125 can be configured to receive the top end of the impeller axis pin therein thereby maintaining the impeller in position and allowing the impeller to rotate about its central axis. When inserted into extension 115 after impeller 120, center opening 415 may be sized and positioned so as to correspond to axis pin 305 of impeller 120 so that axis pin 305 may be inserted into center opening 415.

Puncturing device 125 can have any number of extensions 410 (e.g., 1-100) that extend from a top side of the puncturing device toward a free end. These extensions can be located on the top side in any arrangement, such as a random pattern, a radial pattern or a grid- like pattern. The free end of the extensions 410 can include a sharp edge or blade-like edge that may serve to puncture a bottom lid of the dry powder container 130, which will be discussed below with regard to Figures 5A and 5B. In some instances, extensions 410 may be cut, or otherwise manufactured, so that the upper edge (i.e., the edge that comes into contact with the bottom lid of the dry powder container) is at an angle (e.g., 30°, 45°, 60°, etc.) relative to the bottom end of puncturing device 125 so as to facilitate puncturing of the bottom lid 510 of the dry powder container. The extensions 410 may be of any length including, but not limited to, 3 mm, 5 mm, 7 mm, 10 mm, etc. In addition, the inner diameter of the extensions 410 can be, for example, 0.8 mm - 1.5 mm.

In some embodiments, extensions 410 may be cylindrical in shape and may be hollow in the center so that dry powder and/or air may flow through the hollow center of the extensions 410 through the puncturing device. In some instances, extensions 410 may be of, for example, square, triangular, rectangular, and/or oval shaped.

Figures 5 A is a side plan view of dry powder container 130 and Figure 5B is a top view of dry powder container 130. Dry powder container 130 may include a cup portion 505 and a lid, or cover 510. Cup portion 505 may be shaped so as to contain, or hold, a desired amount (e.g., mass or volume) of dry powder and have an open bottom end. Cup portion 505 may be made from a relatively rigid material like a stiff foil or plastic. Lid 510 may be configured, sized, and positioned so as to seal the open end of cup portion. Lid 510 may be made from a material that can be punctured by one or more of the extensions 410 when the extension 410 is pushed through the lid 510. Lid 510 may be made from any appropriate material including, but not limited to, a foil, a bio-compatible material, bio-absorbable gel, a plastic, etc. Preferably, lid 510 will be comprised of a suitable material such that extensions 410 may puncture lid 510 and dry powder may be expelled from dry powder canister 130.

Dry powder container 130 may contain, for example, an appropriate mass (e.g., 5 mg- 150 mg) of a dry powder or medicine. The dry powder may be compacted into dry powder container 130 with any appropriate density based on, for example, dosage amount and/or characteristics of the dry powder or medicine to be delivered. In some circumstances, dry powder container 130 may include a propellant or other mechanism for assisting with the expelling of the dry powder from dry powder container 130 when dry powder container 130 is punctured by puncturing device 125. In some embodiments, dry powder container 130 may be filled, for example, 50 -90% by volume.

Additionally, or alternatively, dry powder container 130 may be vacuum packed such that the interior portion of dry powder container is under a vacuum with reference to the exterior air. In this circumstance, when dry powder container 130 is punctured, for example by puncturing device 125, breaking the vacuum seal may serve to expel dry powder from the dry powder container 130. By way of further example, in some exemplary implementations, the dry powder container can be made of a flexible material and sized and shaped such that insertion of the dry powder container into the extension and/or placement of the cap over the end of the extension can increase the interior pressure of the dry powder container. Accordingly, the additional pressure within the dry powder container can serve to expel the dry powder from the container when the bottom lid is punctured by the puncturing device.

Figure 6A depicts an interior side perspective view of cap 135 and Figure 6B provides a top plan view of cap 135. Cap 135 may be sized so as to securely fit on top of extension 115. Cap 135 may include an indented area 605 configured to fit over extension 115 and to accommodate positioning of a portion of capsule 130 therein. Cap 135 may also include a sidewall 610 sized and shaped so as to fit over an end of extension 115.

In some circumstances, when cap 135 is placed over the assembly of the impeller 120, puncturing device 125, and dry powder capsule 130 and pushed down so as to fit on top of, or otherwise engage with, extension 115, the downward pressure on cap 135 may be transferred to one or more of dry powder capsule 130 and puncturing device 125 so as to push extensions 410 into capsule 130 thereby releasing the dry powder included therein.

In addition or alternatively, cap 135 can include one or more blades or extensions (not shown) that are configured to puncture the dry powder container at a top or side of the dry powder container (e.g., opposite the bottom side that is be punctured by the puncturing device). In addition, in such a configuration the side walls or the extension provided on the cap itself can include one or more openings thereby allowing air to flow through the dry powder container and serves to aid in the evacuation of dry powder from the bottom of the dry powder container when the user inhales from the first end of the inhalation tube.

Figures 7A-7C provide exploded views of an alternate exemplary inhalation device 700. When fully assembled, inhalation device 700 includes an inhalation tube assembly 710 that includes an inhalation tube 715 and extension 115, impeller 120, puncturing device 125, dry powder capsule 130, a cover 705, and cap 135.

Exemplary dimensions for the components of dry powder inhaler 100 are as follows:

• inhalation tube 715: 15-25 mm in diameter

• extension 115: 18-21 mm in length diameter

• impeller 120: 16-18 mm in diameter

• puncturing device 125: 16-18 mm in diameter

• dry powder container 130: 16-18 mm in diameter • cover 705: 16-25 mm in diameter

When in use a user may place his or her mouth on an end 720 of inhalation tube 715 and may inhale, or otherwise create a negative pressure, so as to draw the dry powder from the dry powder capsule, which has been punctured by puncturing device directly into the user's mouth and lungs.

Figure 8A provides a side perspective view of cover 705 and Figure 8B provides a bottom perspective view of cover 705. Cover 705 may include a covering or cap portion 805 and a tab or handle 810. In some embodiments, cover 705 may be used in lieu of cap 135. For example, cover 705 may be disposable foil and/or plastic that is removed by a user to access dry powder capsule 130.

Figures 9A-9D provide various views of inhalation tube assembly 710. More specifically, Figure 9A depicts the bottom of extension 115 and shows a view of grid 220, which has a series of holes or openings 225 that are configured to allow passage of air as well as a dry powder into the inhalation tube 715. Grid 220 also serves to prevent material that exceeds a preferred size from passing through openings 225.

Figure 9B shows a side plan view of inhalation tube assembly 710 with inhalation tube 715 that includes an open end 905 configured to be inserted into a user's mouth and extension 115 which is configured to accept and house an assembly of impeller 120, puncturing device 125, dry powder capsule 130, cover 705, and cap 135. Inhalation tube 715 is configured without an angle so as to be directly inserted into a user's mouth when the user is, for example, in a supine, or lying down position.

Figure 9C provides a bottom perspective view of inhalation tube showing the openings 220 and center opening 225. Figure 9D shows a side perspective view of inhalation tube 705. Figure 10A provides a view of an assembled inhalation device 700 without cap 135. Stated differently, the assembled inhalation device 700 of Figure 10A includes the assembly of impeller 120, puncturing device 125, dry powder capsule 130, and cover 705. Figure 10B provides a bottom plan view of inhalation device 700, which shows openings 220 as well as the axis pin of impeller 305 inserted into center opening 225.

Figure 11A provides a view of an assembled inhalation device 700 with cap 135. Stated differently, the assembled inhalation device 700 of Figure 10A includes the assembly of impeller 120, puncturing device 125, dry powder capsule 130, cover 705, and cap 135. Figure 11B provides a bottom plan view of inhalation device 700, which shows openings 220 as well as the axis pin of impeller 305 inserted into center opening 225 and the bottom of cap 135.

Figures 12A and 12B depict exploded views of another exemplary inhalation device 1200. Figure 12 A provides a side exploded view of inhalation device 1200 and Figure 12B provides a lower perspective exploded view of inhalation device 1200. Inhalation device 1200 includes extension 115, impeller 120, puncturing device 125, dry powder capsule 130, and cap 135. Inhalation device 1200 also includes a right angle inhalation tube assembly 1210 with a right angle inhalation tube 1205 and extension 115.

Exemplary dimensions for the components of dry powder inhaler 100 are as follows:

• right angle inhalation tube 1205 (lower portion): 40-50 mm in length

• right angle inhalation tube 1205 (upper portion): 25- 35mm in length

• extension 115: 18-21 mm in diameter

• impeller 120: 16-18 mm in diameter

• puncturing device 125: 16-18 mm in diameter

• dry powder container 130: 16-18 mm in diameter Figures 13A-13C provide various views of right angle inhalation tube assembly 1210. Figure 13A depicts a side perspective view of inhalation tube assembly 1210 and shows the length of a lower right angle extension 1305 of right angle inhalation tube 1205 is slightly longer than the length of the combination of extension 115 and upper right angle extension 1310 of right angle inhalation tube 1205. Figure 13B shows a top plan view of right angle inhalation tube assembly 1210 and Figure 13C shows a side perspective view of right angle inhalation tube assembly 1210.

When in use, dry powder inhalers 100, 700, and/or 1200 may be able to deliver a maximum amount of dry powder or dry particles in a single inhalation, which is related to the capacity of the dry powder container 130 (e.g. size 000, 00, OE, 0, 1, 2, 3, and 4, with respective volumetric capacities of 1.37ml, 950μ1, 770μ1, 680μ1, 480μ1, 360μ1, 270μ1, and 200μ1). Accordingly, delivery of a desired dose or effective amount may require two or more inhalations. Preferably, each dose that is administered to a subject in need thereof contains an effective amount of respirable dry particles or dry powder and is administered using no more than about 4 inhalations. For example, each dose of respirable dry particles or dry powder can be administered in a single inhalation or 2, 3, or 4 inhalations. The respirable dry particles and dry powders are preferably administered in a single, breath-activated step using dry powder inhalers 100, 700, and/or 1200. When this type of device is used, the energy of the subject's inhalation both disperses the respirable dry particles and draws them into the respiratory tract.

Referring to Figure 15, in a dry powder inhalation technique, a patient can use a dry powder inhaler 100, 700, and/or 1200 to inhale a dry powder formulation of a drug, such as a NSAID. The dose is effective to reduce a risk of a thromboembolic event in the patient. The lung is an efficient filter, and generally only permits entry of particles having a size of less than 5 μιη. Here, after the drug enters the main stem bronchus, the drug will enter each lung. The drug can then pass through the bronchial trees until reaching the individual alveoli in the lungs. Thus, the dry powder inhaler 100, 700, and/or 1200 can allow the patient to self administer a dosage of particles having a size of from about 1 μιη and about 5 μιη; alternatively, the particle size can be from about 2 μιη to about 4 μιη.

In some instances, blades 310 of impeller 120 may have a sharp edge and, in these instances, blades 310 may serve to cut or otherwise break up (as may be the case with clumping of the dry powder) or otherwise alter dry powder as it flows through impeller 120. Additionally, or alternativly, surfaces of impeller 120, puncturing device 125, interior surfaces of extension 115 and/or interior surfaces of inhalation tube 110, 715, and/or 1205 may be manufactured so that they have a surface with a low coefficient of friction that prohibits attachment of the dry powder thereto. For example, these surfaces may be may be manufactured so as to have a very smooth surface and/or may be coated with a material (e.g., polytetrafluoroethylene (PTFE)) to inhibit attachment of the dry powder thereto.

The dry powder inhaler(s) 100, 700, and/or 1200 disclosed herein may be designed for a one-time/disposable use or repetitive uses. When designed for repetitive use, a user may disassemble dry powder inhaler(s) 100, 700, and/or 1200 in order to, for example, clean or replace one or more components thereof.

EXEMPLARY METHODS OF USE FOR DRY POWDER INHALER

As discussed above, an assembly of impeller 120, puncturing device 125, and dry powder container 130 may reside within extension 115 and may be held in place within extension 115 by cap 135 and/or cover 705. This assembly may be the static, or unused state, of dry powder inhaler(s) 100, 700, and/or 1200. In this way, the assembled dry powder inhaler(s) 100, 700, and/or 1200 may be portable or otherwise easily carried by a user and/or a healthcare provider. In many instances, dry powder inhaler(s) 100, 700, and/or 1200 may be provided with the assembly of impeller 120, puncturing device 125, and dry powder container 130 already positioned within extension 115. In other instances, a user may be required to assemble one or more components of dry powder inhaler(s) 100, 700, and/or 1200 prior to use.

When release of the dry powder residing in the dry powder container 130 is desired, a user and/or patient (in the case where a doctor, or other healthcare provider that is administering the dry powder to the patient) may remove cap 135 and press dry powder capsule 130 onto puncturing device 125 thereby puncturing lid 510 so as to enable the dry powder to be released from dry powder capsule 130. Once released, the dry powder may pass through impeller 120 so that it may be drawn into the lungs of the user and/or patient by way of inhalation tube 110, 715, and/or 1205.

In some embodiments, a user inhaling (or otherwise creating a negative pressure) may cause impeller 120 to rotate and consequently cause a negative pressure, or wind tunnel effect, in the interior of inhalation tube 115 that may serve to assist in the evacuation of dry powder from dry powder container 130 through the interior volume of the extension and into the interior of the inhalation tube 110, 715, and/or 1205 so that the dry power may be inhaled by the user and/or patient. In some implementations, impeller 120 can also be configured to provide feedback to the user and/or patient that it is rotating by producing a noise like a whistle or whirring noise.

In some implementations, dry powder inhaler(s) 100, 700, and/or 1200 and the individual components can be designed, or modified, to accommodate individuals with impaired breathing or with poor rate of inhalation. For example, dry powder inhaler(s) 100, 700, and/or 1200 can be designed to work with an inspiratory flow rate of, for example, 40 - 80 liters per minute. Exemplary design elements of the dry powder inhaler that can be adjusted to accommodate different inspiratory flow rates can include, for example and without limitation, the length and or cross sectional profile of the inhalation tube, the diameter of the extension as well as the diameter or configuration of the impeller (e.g., the size, spacing and angle of the blades and size of the openings between blades). Additional design elements that can be adjusted to achieve certain airflow and dry powder delivery properties can include the size of any combination of the openings and orifices that are provided in the sidewalls or bottom of the extension as well as the openings provided in individual components that comprise the assembly contained within the extension. Varying the size, number and spacing of the extensions or blades that puncture the bottom lid of the dry powder container can also serve to adjust the ease with which the dry powder can be evacuated from the interior of the dry powder container and passed through the dry powder inhalation device.

The foregoing description is provided to enable a person skilled in the art to practice the various configurations described herein. While the subject technology has been particularly described with reference to the various figures and configurations, it should be understood that these are for illustration purposes only and should not be taken as limiting the scope of the subject technology.

There may be many other ways to implement the subject technology. Various functions and elements described herein may be partitioned differently from those shown without departing from the scope of the subject technology. Various modifications to these configurations will be readily apparent to those skilled in the art, and generic principles defined herein may be applied to other configurations. Thus, many changes and modifications may be made to the subject technology, by one having ordinary skill in the art, without departing from the scope of the subject technology.

It is understood that the specific order or hierarchy of steps in the processes disclosed is an illustration of exemplary approaches. Based upon design preferences, it is understood that the specific order or hierarchy of steps in the processes may be rearranged. Some of the steps may be performed simultaneously. The accompanying method claims present elements of the various steps in a sample order, and are not meant to be limited to the specific order or hierarchy presented.

It is to be understood that, while the subject technology has been described in conjunction with the detailed description, thereof, the foregoing description is intended to illustrate and not limit the scope of the subject technology. Thus, while there have been shown, described, and pointed out fundamental novel features of the invention as applied to several embodiments, it will be understood that various omissions, substitutions, and changes in the form and details of the devices illustrated, and in their operation, may be made by those skilled in the art without departing from the spirit and scope of the invention. Substitutions of elements from one described embodiment to another are also fully intended and contemplated. It is also to be understood that the drawings are not necessarily drawn to scale, but that they are merely conceptual in nature. The invention is defined solely with regard to the claims appended hereto, and equivalents of the recitations therein.