INHALATION DEVICE AND METHOD

• US 20110162642A1
• Filed: 01/05/2011
• Published: 07/07/2011
• Est. Priority Date: 01/05/2010
• Status: Active Grant

• Current Assignee: MicroDose Therapeutx, Inc. (Teva Pharmaceutical Industries Limited)
• Original Assignee: MicroDose Therapeutx, Inc. (Teva Pharmaceutical Industries Limited)
• Inventors: Akouka, Henri M., Becker, Daniel P.
• Granted Patent: US 8,991,390 B2
• Time in Patent Office: Days
• US Class Current: 128/200.23
• CPC Class Codes: A61M 15/001 using ultrasonic means
• CPC Class Codes: A61M 15/0021 Mouthpieces therefor
• CPC Class Codes: A61M 15/0043 Non-destructive separation of the package, e.g. peeling
• CPC Class Codes: A61M 15/0045 using multiple prepacked dosages on a same carrier, e.g. blisters
• CPC Class Codes: A61M 15/005 the dosages being arranged on a cylindrical surface
• 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 15/0085 using ultrasonics spraying or atomising liquids using ultrasonic vibrations in general B05B17/06
• CPC Class Codes: A61M 2016/0021 with a proportional output signal, e.g. from a thermistor
• CPC Class Codes: A61M 2202/0266 Nitrogen (N)
• CPC Class Codes: A61M 2202/062 Desiccants
• CPC Class Codes: A61M 2202/064 Powder
• CPC Class Codes: A61M 2205/0294 Piezoelectric materials
• CPC Class Codes: A61M 2205/12 with interchangeable cassettes forming partially or totally the fluid circuit
• CPC Class Codes: A61M 2205/8206 battery-operated
• CPC Class Codes: A61M 2250/00 Specially adapted for animals

Abstract

The present disclosure provides a method and device for delivering a pharmaceutical to the airway of a human or animal patient. In one aspect, the device includes a dose drum formed into a cylinder and including a plurality of dose compartments for containing individual doses. In another aspect, the device may include a reservoir containing a pharmaceutical material in bulk form and a metering recess for metering the pharmaceutical material to form a pharmaceutical dose. Another aspect provides an inhaler with a combined reservoir and dosing chamber configured to contain multiple doses of a pharmaceutical material.

Claims

1. A pharmaceutical delivery package containing a plurality of individual doses of a pharmaceutical, comprising:

a dose drum formed of a substrate material configured as a cylinder, the dose drum including a plurality of dose compartments for containing the individual doses of a pharmaceutical; and

a sheath surrounding the dose drum to contain and segregate the plurality of individual doses of a pharmaceutical in the dose compartments.

2. The pharmaceutical delivery package of claim 1, wherein the pharmaceutical is in the form of a dry powder.

3. The pharmaceutical delivery package of claim 1, wherein the sheath is formed to fit tightly around an outer surface of the dose drum, the sheath having at least two holes, including:

a first hole for filling the dose compartment with a pharmaceutical; and

a second hole for allowing the delivery of one of said plurality of individual doses of a pharmaceutical.

4. The pharmaceutical delivery package of claim 1, wherein the sheath is formed of a tape, foil or film.

5. The pharmaceutical delivery package of claim 1, wherein each of the plurality of dose compartments comprise a recessed volume on an outer surface of the cylinder, the recessed volume extending towards the center of the dose drum.

6. The pharmaceutical delivery package of claim 1, wherein the plurality of dose compartments are arranged in a series of rows which extend around the circumference of the dose drum.

7. The pharmaceutical delivery package of claim 1, wherein the plurality of dose compartments are arranged in a helical pattern.

8. The pharmaceutical delivery package of claim 1, wherein the dose drum is formed as a dose ring, the plurality of dose compartments being arranged in a single row about the circumference of the cylinder.

9. An inhaler for delivering a pharmaceutical to the airway of a human or animal patient, comprising:

a dose drum in the form of a cylinder, the dose drum including a plurality of dose compartments for containing individual doses of a pharmaceutical;

a sheath surrounding the dose drum;

a dose chamber; and

a flow channel, through which the individual dose is delivered to the airway of the patient.

10. The inhaler of claim 9, wherein the dose chamber is a resonance chamber coupled to a vibration device.

11. The inhaler of claim 10, wherein the vibration device is a piezo-electric device.

12. The inhaler of claim 10, wherein the vibration device is connected to a frequency generator for controlling the vibration of the vibration device.

13. The inhaler of claim 9, wherein the sheath has at least two holes, including a first hole for filling the dose compartment with a pharmaceutical and a second hole for delivering the individual dose to the dose chamber.

14. The inhaler of claim 9, further comprising a drive for advancing and positioning the dose drum.

15. The inhaler of claim 9, wherein the sheath is formed of a tape, foil or film that may be removed from a single dose compartment when delivering the individual dose contained in said dose compartment to the dose chamber.

16. The inhaler of claim 9, further comprising at least a second dose drum.

17. A pharmaceutical delivery package containing a plurality of individual doses of a pharmaceutical, forming a cartridge, the contents of which comprise:

a strip formed of a substrate material, the strip further comprising a substrate having a plurality of depressions arranged in a series and formed to contain the individual doses of a pharmaceutical, and a foil, film or tape sealing the depressions, wherein the individual depressions sealed by the foil, film or tape form a plurality of blisters;

an aerosol chamber for deaggregating the individual dose of a pharmaceutical; and

a device for advancing the blister strip relative to the aerosol chamber.

18. The pharmaceutical package of claim 17, wherein the device for advancing the strip is actuated using one or more of the group consisting of:

an arm, a spring, a cam, a gear, and a wheel.

19. The pharmaceutical package of claim 17, wherein the contents of the cartridge further comprise a blister detection switch for controlling the device for advancing the strip to consistently position individual blisters relative to the aerosol chamber.

20. The pharmaceutical package of claim 17, wherein the contents of the cartridge further comprise a device for removing the foil, film or tape from individual blister as it is advanced relative to the aerosol chamber.

21. The pharmaceutical package of claim 20, wherein the contents of the cartridge further comprise take-up spool for collecting the foil, film or tape as it is removed from the strip.

22. The pharmaceutical package of claim 17, wherein the contents of the cartridge further comprise take-up spool for collecting the foil, film or tape as it is removed from the strip.

23. The pharmaceutical package of claim 17, wherein the cartridge includes a mouthpiece for delivering the individual dose of pharmaceutical to the airway of a patient;

and a flow channel, wherein the flow channel is connected to the aerosol chamber and the mouthpiece.

24. The pharmaceutical package of claim 17, wherein the pharmaceutical is in a powder form.

25. The pharmaceutical package of claim 17, wherein the cartridge is reusable.

26. An inhaler for delivering a pharmaceutical to the airway of a human or animal patient, comprising:

a housing having an air inlet, the housing containing a vibrating device and a motor or mechanical advancing mechanism, such as a thumb-screw, lever or clock mechanism, for example;

a removable cartridge formed to interface with the housing, the cartridge forming a loop, wherein the removable cartridge further comprises;

a strip arranged within the loop of the cartridge having a plurality of blisters containing individual doses of a pharmaceutical;

a flow channel;

an aerosol chamber connected to the flow channel; and

a device for advancing the strip relative to the aerosol chamber;

wherein the air inlet interfaces with the flow channel of the cartridge, and wherein the vibrating device interfaces with the aerosol chamber.

27. The inhaler of claim 26, further comprising a sealing ring positioned at the location where the air inlet of the housing interfaces with the flow channel of the cartridge.

28. The inhaler of claim 26, wherein the cartridge includes a mouthpiece connected to the flow channel for delivering the pharmaceutical to the patient.

29. The inhaler of claim 26, wherein the housing further includes a pressure sensor located in or near the air inlet.

30. The inhaler of claim 26, wherein the device for advancing the strip is driven by the motor or a mechanical advancing mechanism, such as a thumb-screw, lever or clock mechanism, contained within the housing.

31. The inhaler of claim 26, wherein the aerosol chamber and the vibrating device form a resonance chamber for deaggregating the pharmaceutical.

32. The inhaler of claim 26, wherein the vibrating device is a piezoelectric device.

33. The inhaler of claim 26, wherein the pharmaceutical is in a powder form.

34. The inhaler of claim 26, wherein the removable cartridge is reusable.

35. A method of delivering a pharmaceutical material to the airway of a patient, human or animal, the method comprising the steps of:

providing the pharmaceutical material in a reservoir connected to a metering device;

metering the pharmaceutical material with the metering device to form a pharmaceutical dose;

moving the pharmaceutical dose into a dose chamber;

deaggregating the pharmaceutical material of the pharmaceutical dose; and

delivering the pharmaceutical dose from the dose chamber to the airway of the patient via a flow channel.

36. The method of claim 35, wherein the metering device comprises a metering drum which rotates upon its axis, the at least one metering recess being located on an outward facing surface of the metering drum;

and a sheath surrounding the outward facing surface of the metering drum, wherein the sheath has at least two holes, including a first hole for filling the recess with the pharmaceutical material and a second hole for delivering the pharmaceutical dose to the dose chamber.

37. The method of claim 36, wherein the step of moving the pharmaceutical dose into the dose chamber involves rotating the metering drum.

38. The inhaler of claim 35, wherein the metering device comprises a metering compartment enclosed between a first metering door and a second metering door, wherein the second metering door is opened during the step of metering the pharmaceutical material, and the first metering door is opened during the step of moving the pharmaceutical dose into the dose chamber.

39. The method of claim 35, wherein the reservoir is a cylinder, the reservoir further comprising a compression spring and piston for loading the pharmaceutical material into the metering device.

40. The method of claim 35, wherein the pharmaceutical material is in the form of a dry powder.

41. The method of claim 35, wherein the dose chamber is a resonance chamber coupled to a vibration device, and wherein the step of deaggregating the pharmaceutical material involves activating the vibration device to create a synthetic jet thereby delivering the pharmaceutical dose from the dose chamber to the airway of the patient via a flow channel.

42. An inhaler for delivering a pharmaceutical material to the airway of a patient, human or animal, comprising:

a reservoir containing a pharmaceutical material;

at least one metering recess metering the pharmaceutical material to form a pharmaceutical dose;

a dose chamber;

a flow channel, connected to the dose chamber, through which the pharmaceutical dose is delivered from the dose chamber to the airway of the patient.

43. The inhaler of claim 42, further comprising:

a metering drum which rotates upon its axis, the at least one metering recess being located on an outward facing surface of the metering drum; and

a sheath surrounding the outward facing surface of the metering drum, wherein the sheath has at least two holes.

44. The inhaler of claim 43, wherein the at least two holes in the sheath include a first hole for filling the recess with the pharmaceutical material and a second hole for delivering the pharmaceutical dose to the dose chamber.

45. The inhaler of claim 43, further comprising a drive for rotating the metering drum.

46. The inhaler of claim 42, wherein the metering recess is enclosed between a first metering door and a second metering door, wherein when the second metering door is opened, the metering recess may be filled with the pharmaceutical material, and wherein when the first metering door is opened, the pharmaceutical dose may be delivered to the dose chamber.

47. The inhaler of claim 42, wherein the reservoir is a cylinder, the reservoir further comprising a compression spring and piston for loading the pharmaceutical into the recess.

48. The inhaler of claim 42, wherein the pharmaceutical is in the form of a dry powder.

49. The inhaler of claim 42, wherein the dose chamber is a resonance chamber coupled to a vibration device.

50. The inhaler of claim 49, wherein the vibration device is connected to a frequency generator for controlling the vibration of the vibration device.

51. The inhaler of claim 42, further comprising a second metering recess, wherein the second metering recess meters and loads a second pharmaceutical material into said dose chamber.

52. An inhaler for delivering a pharmaceutical material to the airway of a human or animal patient, comprising:

a combined reservoir and dosing chamber having one or more apertures formed in a wall of the chamber, the combined reservoir and dosing chamber being sized to contain multiple doses of the pharmaceutical material;

a flow channel, through which individual doses are delivered to the airway of the patient;

a vibratory device coupled to the combined reservoir and dosing chamber, wherein the combined reservoir and dosing chamber is a resonance chamber coupled to a vibration device; and

a controller for controlling the vibratory device.

53. The inhaler of claim 52, wherein the vibratory device is a piezo-electric device.

54. The inhaler of claim 52, wherein the vibratory device is connected to a frequency generator for controlling the vibration of the vibratory device.

55. The inhaler of claim 52, wherein the chamber includes a chamber seal.

56. The inhaler of claim 55, wherein the chamber seal is connected to at least one of a group consisting of:

a source of pressurized gas, a vacuum and desiccant source.

57. A method of delivering a single dose of a pharmaceutical material to the airway of a patient, human or animal, the method comprising the steps of:

providing the pharmaceutical material in a combined reservoir and dosing chamber, the chamber having one or more holes in a side wall thereof, and the amount of pharmaceutical material being equal to multiple doses thereof;

coupling the chamber to a vibratory device;

deaggregating the pharmaceutical material by activating the vibratory device; and

controlling the vibratory device to deliver a single dose from the combined reservoir and dosing chamber to the airway of the patient.

58. The method of claim 57, wherein the step of controlling the vibratory device comprises controlling the duration of operation of the vibratory device;

controlling a vibrating frequency of the vibratory device;

or controlling the duration of operation and the vibrating frequency of the vibratory device.