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

• US 20050126569A1
• Filed: 01/26/2005
• Published: 06/16/2005
• Est. Priority Date: 05/10/2002
• Status: Active Grant

• Current Assignee: Anthony J. Hickey, Jeffrey A. Warden, Timothy M. Crowder
• Original Assignee: Anthony J. Hickey, Jeffrey A. Warden, Timothy M. Crowder
• Inventors: Crowder, Timothy M., Hickey, Anthony J., Warden, Jeffrey A.
• Granted Patent: US 7,520,278 B2
• Time in Patent Office: Days
• US Class Current: 128/203.150
• 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 for holding and/or dispensing pharmaceutical grade formulations of inhalable dry powder substances, comprising:

a platform body comprising at least one releasably sealed dry powder receptacle comprising a quantity of dry powder;

at least one vibratory member in the inhaler; and

an input signal generating circuit that is operatively associated with the at least one vibratory member, wherein the input generating circuit comprises a processor configured to selectively transmit an amplitude modulated non-linear input signal to the vibratory member, and wherein the amplitude modulated non-linear signal comprises a plurality of superimposed frequencies, the frequencies corresponding to a priori flow characteristic frequencies of the dry powder held in a respective receptacle.

2. An inhaler according to claim 1, wherein the vibratory member comprises a piezoelectric polymer that flexes and vibrates the dry powder in response to the amplitude modulated non-linear signal from the input signal generating circuit.

3. An inhaler according to claim 2, wherein the processor comprises program code that:

(a) generates a priming signal that is transmitted to the piezoelectric polymer prior to active inhalation; and

(b) generates the non-linear vibration input signal that is transmitted to the piezoelectric polymer during inhalation.

4. An inhaler according to claim 1, wherein the platform body comprises a plurality of spaced apart dry powder receptacles, each receptacle comprising a floor that comprises a piezoelectric polymer material, each receptacle defining a respective vibratory member for the dry powder held therein, and wherein, in operation, at least one selected receptacle floor flexes in response to the amplitude modulated non-linear signal from the input signal generating circuit.

5. An inhaler according to claim 1, further comprising a first dry powder substance disposed in a first receptacle and a second different dry powder substance disposed in a second receptacle, and wherein, during use, both of the first and second substances are vibrated using the amplitude modulated non-linear signal and substantially concurrently dispensed to the patient by the inhaler.

6. An inhaler according to claim 5, wherein the first receptacle is formed in a first package body and the second receptacle is formed in a separate second package body.

7. An inhaler according to claim 5, further comprising a third receptacle holding a third dry powder substance, wherein the first, second and third substances are substantially concurrently dispensed to the patient by the inhaler.

8. An inhaler according to claim 1, wherein the non-linear input signal is a low energy input signal having a plurality of superpositioned modulating frequencies, and wherein the non-linear input signal comprises frequencies in the range of between about 10 Hz to 1000 kHz.

9. An inhaler according to claim 1, wherein the non-linear input signal comprises carrier frequencies in the range of between about 15 kHz to 50 kHz.

10. An inhaler according to claim 1, wherein the inhaler comprises a window that overlies a portion of a multidose package that comprises a plurality of spaced apart receptacles to thereby allow a user to view the package.

11. An inhaler according to claim 10, wherein the multidose package comprises externally visible indices of a dose number that are visible through the window during use.

12. A dry powder inhaler, comprising:

a package body comprising at least one releasably sealed drug compartment having a meted quantity of dry powder therein;

at least one piezoelectric member in an inhalation flow path in communication with dry powder from the at least one drug compartment; and

an input signal generating circuit in communication with the piezoelectric member, wherein the input signal generating circuit is configured to generate an amplitude modulated non-linear electrical input signal to vibrate the piezoelectric member, the non-linear signal comprising frequencies selected to represent a priori flow characteristic frequencies of the dry powder formulation held in the at least one drug compartment.

13. A dry powder inhaler according to claim 12, wherein the amplitude modulated non-linear input signal comprises a plurality of superimposed selected frequencies of the dry powder formulation held in the at least one drug compartment.

14. A dry powder inhaler according to claim 12, wherein the at least one piezoelectric member comprises a piezoelectric polymer material with conductive material attached to the piezoelectric polymer material, wherein, in operation, the input signal generating circuit transmits the amplitude-modified non-linear signal to flex the piezoelectric polymer material to vibrate dry powder during inhalation.

15. A dry powder inhaler according to claim 14, wherein the package body is a multi-dose package with a plurality of spatially separated drug compartments, wherein the piezoelectric polymer material forms a portion of each drug compartment, and wherein the input circuit is configured to selectively flex the piezoelectric polymer material using the non-linear signal to vibrate dry powder during inhalation.

16. A dry powder inhaler according to claim 12, wherein the a priori flow characteristic frequencies correspond to a plurality of observed frequencies in an avalanche-analysis spectrum of the dry powder.

17. A dry powder inhaler according to claim 14, wherein the superimposed selected frequencies comprise amplitude weighted flow characteristic frequencies.

18. A dry powder inhaler according to claim 12, wherein the amplitude modulated non-linear input signal “

x_signal”

is a cumulative signal that comprises a sum of selected observed frequencies derived from an avalanche-analysis spectrum of the dry powder.

19. A dry powder inhaler according to claim 18, wherein the non-linear input signal “

x_signal”

is derived from the mathematical equation;

20. A dry powder inhaler according to claim 19, wherein one or more of the weighted summed frequency components is multiplied by a mathematical phase adjustment.

21. A dry powder inhaler according to claim 19, wherein f₂, f₃, f₄ are the most observed frequencies in an avalanche-based analysis spectrum of the dry powder.

22. A dry powder inhaler according to claim 12, wherein the input signal generating circuit is configured to generate and transmit a priming signal to the piezoelectric member prior to the amplitude modified non-linear amplitude signal.

28. A dry powder inhaler according to claim 12, wherein the a priori flow characteristic frequencies correspond to a plurality of observed frequencies in an avalanche-analysis spectrum of the target dry powder.

29. A dry powder inhaler according to claim 28, wherein the superimposed selected frequencies comprise amplitude weighted flow characteristic frequencies.

23. A dry powder inhaler, comprising:

at least one piezoelectric polymer member; and

an input signal generating circuit in communication with the at least one piezoelectric polymer member, wherein the input signal generating circuit is configured to generate an amplitude modulated non-linear electrical input signal to vibrate the piezoelectric polymer member, the non-linear signal comprising frequencies selected to represent a priori flow characteristic frequencies of a target inhalable dry powder.

24. A dry powder inhaler according to claim 23, wherein the amplitude modulated non-linear input signal comprises a plurality of superimposed selected frequencies of the target dry powder formulation.

25. A dry powder inhaler according to claim 23, wherein the at least one piezoelectric polymer material comprises conductive material attached thereto, wherein, in operation, the input signal generating circuit transmits the amplitude-modified non-linear signal to flex the piezoelectric polymer material to vibrate dry powder during inhalation.

26. A dry powder inhaler according to claim 25, further comprising a package body is a multi-dose package with a plurality of spatially separated drug compartments.

27. A dry powder inhaler according to claim 26, wherein the piezoelectric polymer material forms a portion of each drug compartment, and wherein the input circuit is configured to selectively flex the piezoelectric polymer material associated with a selected drug compartment using the non-linear signal to vibrate dry powder during inhalation.

30. A dry powder inhaler, comprising:

an elongate body having opposing first and second outer primary surfaces with a 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 formed in the bottom end portion of the elongate body, 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 moves between a first closed position to overlie the inhalation port 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 allow a user to access the inhalation port.

31. A dry powder inhaler according to claim 30, wherein the cover member has a length and a width and the elongated body has a length and a width, and wherein the cover member length is greater than a major portion of the length of the elongated body and the cover member width is less than the width of the elongate body.

32. A dry powder inhaler according to claim 30, wherein the cover member has two opposing first and second end portions, the first end portion being pivotally attached to an upper portion of the elongated body, the cover having a major portion with a substantially planar profile and a downwardly extending arcuately shaped second end portion.

33. A dry powder inhaler according to claim 32, wherein the arcuately shaped end portion extends a distance to snugly abut and wrap around and conform to the bottom portion of the elongate body, and wherein the cover member is an elastomeric flexible cover.

34. A dry powder inhaler according to claim 30, 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 is pivotally attached to pivot about an axis that extends through and normal to the window.

35. A dry powder inhaler according to claim 34, wherein the multidose package comprises externally visible indices of the dose number that are visible through the window during use.

36. A dry powder inhaler according to claim 30, 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.

37. A dry powder inhaler according to claim 30, wherein the elongate body further comprises a depressible user activation button accessible via the first surface and a dose advancing knob on the opposing side of the elongate body in communication with the multi-dose package.

38. A dry powder inhaler according to claim 37, wherein the cover member has a major portion that is substantially planar with an outwardly projecting portion, the outwardly projecting portion configured to overlie the activation button on the first surface of the elongate body when the cover member is closed over the inhalation port to inhibit inadvertent activation.

39. A dry powder inhaler according to claim 30, wherein with the cover member in the closed position, the elongate body has a thin profile with substantially flat first and second primary surfaces defining a pocket-sized inhaler that fits into the pocket of a garment worn by a user.

40. A dry powder inhaler according to claim 30, wherein the inhalation port is formed in a mouthpiece that is releaseably attached to the elongate body bottom portion thereby allowing periodic cleaning or replacement.

41. A dry powder inhaler according to claim 30, 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.

42. A dry powder inhaler according to claim 41, 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.

43. A dry powder inhaler according to claim 41, wherein the control circuitry is configured to detect a predetermined electrical parameter associated with the position of one of the elongate channels with respect to the inhalation port to affirm proper alignment before allowing active dispersement of the dry powder dose.

44. A dry powder inhaler according to claim 43, wherein the blisters comprise piezoelectric polymer material, and wherein the electric parameter comprises capacitance of the piezoelectric polymer material.

45. A dry powder inhaler according to claim 41, wherein the blisters 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.

46. A dry powder inhaler according to claim 30, wherein the dry powder is a low density dry powder, and wherein the inhalable dry powder held in the multi-dose blister package comprises active ingredient particulate sizes of between about 0.5-8.0 μ

m.

47. A dry powder inhaler according to claim 30, 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.

48. A dry powder inhaler according to claim 30, wherein the blisters comprise elongate channels 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.

49. A dry powder inhaler according to claim 41, 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.