Dry powder inhalers, related blister devices, and associated methods of dispensing dry powder substances and fabricating blister packages

• US 7,520,278 B2
• Filed: 01/26/2005
• Issued: 04/21/2009
• Est. Priority Date: 05/10/2002
• Status: Expired due to Term

• Current Assignee: Oriel Therapeutics, Inc. (Novartis Ag)
• Original Assignee: Oriel Therapeutics, Inc. (Novartis Ag)
• Inventors: Warden, Jeffrey A., Crowder, Timothy M., Hickey, Anthony J.
• Primary Examiner(s): DeMille; Danton
• Assistant Examiner(s): DIXON, ANNETTE FREDRICKA
• Application Number:
  US11/043,363
• Publication Number:
  US 20050126569A1
• Time in Patent Office: 1,546 Days
• Field of Search: 604/58, 128/200.14, 128/200.19, 128/200.23, 128/200.24, 128/203.15, 128/203.19, 128/203.21, 128/205.23, 128/203.12, 128/203.23, 128/200.25, 128/202.26, 128/202.25
• US Class Current: 128/203.15
• CPC Class Codes: A61M 15/0003 with means for dispensing more than one drug
• CPC Class Codes: A61M 15/0005 with means for agitating the medicament
• CPC Class Codes: A61M 15/001 using ultrasonic means
• CPC Class Codes: A61M 15/0048 the dosages being arranged in a plane, e.g. on diskettes
• CPC Class Codes: A61M 15/0051 the dosages being arranged on a tape, e.g. strips
• CPC Class Codes: A61M 15/0055 the used dosages being coiled
• CPC Class Codes: A61M 15/0065 Inhalators with dosage or measuring devices A61M15/0028 takes precedence; dosage devices incorporated in aerosol cans B65D83/52
• CPC Class Codes: A61M 15/0075 on a disc
• CPC Class Codes: A61M 2202/064 Powder
• CPC Class Codes: A61M 2205/18 with alarm
• CPC Class Codes: A61M 2205/35 Communication
• CPC Class Codes: A61M 2205/52 with memories providing a history of measured variating parameters of apparatus or patient
• CPC Class Codes: A61M 2205/8206 battery-operated
• CPC Class Codes: B65B 37/04 by vibratory feeders
• CPC Class Codes: B65D 88/66 using vibrating or knocking devices
• CPC Class Codes: B65G 53/66 Use of indicator or control devices, e.g. for controlling gas pressure, for controlling proportions of material and gas, for indicating or preventing jamming of material controlling the flow of coal firing systems C21B5/003

Abstract

The present invention includes dry powder inhalers for dispensing and/or holding inhalant formulated dry powder substances and associated fabrication and dispensing methods that can employ an amplitude modulated non-linear signal comprising a plurality of superimposed frequencies, the frequencies corresponding to a priori flow characteristic frequencies of the dry powder being dispensed. The present invention also includes pocket-sized inhalers with an elastomeric flexible pivoting cover.

Claims

1. A dry powder inhaler, comprising:

an elongate body having opposing first and second outer primary surfaces with a substantially enclosed cavity therebetween and having opposing top and bottom end portions;

a multi-dose sealed blister package holding a plurality of discrete meted doses of a dry powder inhalable product located in the cavity of the elongate body;

an inhalation port extending through a mouthpiece in the bottom end portion of the elongate body so as to be externally accessible by a user while the elongate body remains closed, the inhalation port configured to be in fluid communication with at least one of the discrete meted doses during use; and

a cover member that is pivotally attached to the elongate body and rotates between a first closed position to overlie the inhalation port and mouthpiece at the bottom end portion of the body during periods of non-use and a second open position away from the inhalation port during periods of use to expose the inhalation port and mouthpiece and allow a user to access the inhalation port on the bottom end of the elongate body while the elongate body remains closed, wherein the cover member has a length and width sufficient to extend from the bottom end to proximate the top end portion of the inhaler body when the cover is in the closed position, and wherein the cover has a first end portion with an arcuate profile that extends downwardly substantially conformally over the inhaler bottom end when in the closed position.

2. A dry powder inhaler according to claim 1, wherein the elongate body is a substantially closed body that remains closed during use with the cover member rotating away to allow a user access to the inhalation port and mouthpiece, wherein the elongate body has rounded top and bottom end portions, wherein the mouthpiece has a contour with a radius of curvature that is substantially the same as adjacent portions of the inhaler elongate body, and wherein the cover member width is less than a width of the elongate body and snugly abuts the mouthpiece when in the closed configuration, and wherein the cover member pivots toward a side of the inhaler elongate body to move to the open position with a planar pivoting portion of the cover member remaining on and contacting the first primary surface of the inhaler elongate body both in the open and closed positions.

3. A dry powder inhaler according to claim 1, wherein the cover member has opposing first and second end portions, the first end portion being pivotally attached to the first primary surface of the elongate body proximate a top end portion of the inhaler, the cover member having a substantially planar profile that merges into the second end portion with a lower portion thereof that turns and extends toward an opposing end of the inhaler.

4. A dry powder inhaler according to claim 3, wherein the cover member comprises a mound that cooperates with the elongate body to define an air pocket between an underlying activation switch and the mound.

5. A dry powder inhaler according to claim 1, wherein the first primary surface of the elongate body comprises a window that overlies a portion of the multidose package, and wherein the cover member comprises an aperture that is aligned with the window, and wherein the cover member is pivotally attached to the elongate body to pivot about an axis that extends through and normal to the window and rotates about the window.

6. A dry powder inhaler according to claim 5, wherein the multidose package comprises externally visible indices of a dose number that are visible through the window during use.

7. A dry powder inhaler according to claim 1, wherein the multidose package includes at least one of a visible or audible alert warning that alerts the user when the multi-dose package approaches the last few remaining doses.

8. A dry powder inhaler according to claim 1, wherein the elongate body further comprises a depressible user activation button accessible via the first primary surface and a dose advancing knob on a side of the elongate body in communication with the multi-dose package whereby the multi-dose package can be rotated.

9. A dry powder inhaler according to claim 8, wherein the first outer primary surface is a planar top surface and the second outer primary surface is a planar bottom surface of the inhaler, wherein the elongate body has a thin profile when viewed from the side with the mouthpiece having a contour that blends with a contour of the bottom end portion of the elongate body, and wherein the cover member is substantially planar with an outwardly projecting mound portion, the outwardly projecting mound portion configured to overlie the activation button on the first primary surface of the elongate body when the cover member is closed over the inhalation port to inhibit inadvertent activation.

10. A dry powder inhaler according to claim 1, wherein with the cover member in the closed position, the inhaler has a thin profile with substantially flat first and second outer primary surfaces, rounded top and bottom ends, and parallel long sides that define a substantially oval perimeter shaped pocket-sized inhaler that fits into the pocket of a garment worn by a user.

11. A dry powder inhaler according to claim 1, wherein the mouthpiece defines a portion of an outer surface of the inhaler and is releaseably attached to the elongate body bottom end portion thereby allowing periodic cleaning or replacement, and wherein the inhaler elongate body has a curvilinear recessed neck that is sized and configured to releasably attach to the mouthpiece.

12. A dry powder inhaler according to claim 1, further comprising:

control circuitry held in the elongated body; and

a battery operatively associated with the control circuitry,

wherein the control circuitry is configured to generate an amplitude-modified non-linear signal corresponding to a priori flow characteristics of a dry powder being dispensed to selectively vibrate powder in a selected blister held by the multi-dose blister package.

13. A dry powder inhaler according to claim 12, wherein the non-linear signal comprises a plurality of predetermined superimposed frequencies selected according to a priori flow characteristics of the dry powder being dispensed.

14. A dry powder inhaler according to claim 12, wherein the control circuitry is configured to detect a predetermined electrical parameter associated with the position of one of a plurality of elongate channels of the multi-dose package with respect to the inhalation port to affirm proper alignment before allowing active dispersement of the corresponding dry powder dose.

15. A dry powder inhaler according to claim 14, wherein the multi-dose blister package has blisters that comprise piezoelectric polymer material, and wherein the electric parameter comprises capacitance of the piezoelectric polymer material.

16. A dry powder inhaler according to claim 12, wherein the multi-dose blister package has blisters that comprise piezoelectric polymer material, and wherein, in operation, the control circuitry is configured to apply the electrical input so that an excitation voltage differential is transmitted to cause said piezoelectric polymer material to flex thereat to promote resonance of the dry powder and actively disperse a dry powder pharmaceutical drug through the inhalation port.

17. A dry powder inhaler according to claim 12, wherein the multi-dose blister package comprises:

a platform body comprising at least one piezoelectric polymer material layer forming at least a portion of each of a plurality of spatially separated discrete blisters having elongate dry powder channels having an associated length, width and height; and

a conductive pattern configured on the platform body so as to be in communication with the control circuitry, the conductive pattern being attached to selected portions of the piezoelectric polymer material including each of the regions corresponding to the blisters to define active energy releasing vibratory channels, wherein, in operation, the control circuitry generates an electrical input that is transmitted via the conductive pattern to flex the piezoelectric polymer material associated with at least one selected blister and vibrate the dry powder in the associated at least one elongate channel.

18. A dry powder inhaler according to claim 1, wherein the inhalable dry powder is a low density dry powder with active ingredient particulate sizes of between about 0.5-8.0 μ

m.

19. A dry powder inhaler according to claim 1, wherein the inhaler comprises a dose releasing member with a forward edge portion that has a shape that corresponds to a shape of a semi-spherical portion of a blister ceiling on the multi-dose package.

20. A dry powder inhaler according to claim 1, wherein the multi-dose package has blisters with elongate blister channels for holding the dry powder having an internal cavity profile, the inhaler further comprising a dose releasing member disposed in the inhaler to advance toward and retract away from a ceiling side of the multi-dose package, and wherein the dose releasing member has a forward edge portion that has a shape that corresponds to a shape of the cavity profile.

21. A dry powder inhaler according to claim 1, wherein the mouthpiece is non-protruding and has a contour that is a continuation of adjacent sides of the inhaler elongate body to define a continuous rounded contour of the bottom end of the inhaler.

22. A dry powder inhaler according to claim 1, wherein the cover member pivots to be able hang over both a top end of the inhaler, the top end residing away from the inhalation port on a bottom end of the inhaler, and long sides of the inhaler.

23. A dry powder inhaler according to claim 1, wherein the cover member conceals an activation button on the first primary surface when in the closed position and exposes the activation button when in the open position.

24. A dry powder inhaler according to claim 1, wherein the inhaler comprises an indexing mechanism that rotates the blister package, and wherein the blister package has stops or detents that cooperate with the inhaler body to provide tactile and/or audible feedback to a user to verify that the blister package is in a desired dispensing position.