DRY POWDER DELIVERY DEVICE

• US 20120291781A1
• Filed: 12/26/2010
• Published: 11/22/2012
• Est. Priority Date: 12/26/2009
• Status: Active Grant

• Current Assignee: Inspiro Medical Ltd.
• Original Assignee: Inspiro Medical Ltd.
• Inventors: Kaufmann, Nimrod, Steuer, Guy
• Granted Patent: US 10,173,019 B2
• Time in Patent Office: Days
• US Class Current: 128/203.15
• CPC Class Codes: A61M 11/001 Particle size control
• CPC Class Codes: A61M 11/005 using ultrasonics spraying or atomising liquids using ultrasonic vibrations in general B05B17/06
• CPC Class Codes: A61M 11/02 operated by air or other gas pressure applied to the liquid or other product to be sprayed or atomised sprayers for horticulture A01G, A01H; killing insects A01M; air humidifying by nozzles F24F6/14, F24F6/18; cooling by spraying F28B, F28C
• CPC Class Codes: A61M 11/06 of the injector type
• CPC Class Codes: A61M 15/0003 with means for dispensing more than one drug
• CPC Class Codes: A61M 15/001 using ultrasonic means
• CPC Class Codes: A61M 15/0016 located downstream of the dispenser, i.e. traversed by the product
• CPC Class Codes: A61M 15/0018 with exhalation check valves
• CPC Class Codes: A61M 15/0021 Mouthpieces therefor
• CPC Class Codes: A61M 15/0028 using prepacked dosages, one for each application, e.g. capsules to be perforated or broken-up
• CPC Class Codes: A61M 15/003 using capsules, e.g. to be perforated or broken-up
• CPC Class Codes: A61M 15/0035 Piercing means
• CPC Class Codes: A61M 15/0038 Cutting means
• CPC Class Codes: A61M 15/0045 using multiple prepacked dosages on a same carrier, e.g. blisters
• CPC Class Codes: A61M 15/008 Electronic counters
• CPC Class Codes: A61M 15/0081 Locking means
• CPC Class Codes: A61M 15/0085 using ultrasonics spraying or atomising liquids using ultrasonic vibrations in general B05B17/06
• CPC Class Codes: A61M 16/0063 Compressors
• CPC Class Codes: A61M 16/06 Respiratory or anaesthetic masks
• CPC Class Codes: A61M 16/0666 Nasal cannulas or tubing devices for improving normal breathing through the nose A61F5/08; nose filters A62B23/06; outside holding devices A61M25/02
• CPC Class Codes: A61M 16/14 : by mixing different fluids, one of them being in a liquid phase
• CPC Class Codes: A61M 16/202 : electrically actuated
• CPC Class Codes: A61M 16/204 : used for inhalation control
• CPC Class Codes: A61M 2016/0021 : with a proportional output signal, e.g. from a thermistor
• CPC Class Codes: A61M 2016/0033 : electrical
• CPC Class Codes: A61M 2202/0208 : Oxygen
• CPC Class Codes: A61M 2202/025 : Helium
• CPC Class Codes: A61M 2202/064 : Powder
• CPC Class Codes: A61M 2205/07 : having air pumping means
• CPC Class Codes: A61M 2205/071 : hand operated
• CPC Class Codes: A61M 2205/27 : preventing use
• CPC Class Codes: A61M 2205/276 : preventing unwanted use
• CPC Class Codes: A61M 2205/3331 : Pressure; Flow
• CPC Class Codes: A61M 2205/3355 : Controlling downstream pump pressure
• CPC Class Codes: A61M 2205/3553 : remote, e.g. between patient's home and doctor's office
• CPC Class Codes: A61M 2205/3561 : local, e.g. within room or hospital
• CPC Class Codes: A61M 2205/3584 : using modem, internet or bluetooth
• CPC Class Codes: A61M 2205/3592 : using telemetric means, e.g. radio or optical transmission
• CPC Class Codes: A61M 2205/50 : with microprocessors or computers
• CPC Class Codes: A61M 2205/502 : User interfaces, e.g. screens or keyboards
• CPC Class Codes: A61M 2205/52 : with memories providing a history of measured variating parameters of apparatus or patient
• CPC Class Codes: A61M 2205/581 : by audible feedback
• CPC Class Codes: A61M 2205/583 : by visual feedback
• CPC Class Codes: A61M 2205/6018 : providing set-up signals for the apparatus configuration
• CPC Class Codes: A61M 2205/6054 : Magnetic identification systems
• CPC Class Codes: A61M 2205/6072 : Bar codes
• CPC Class Codes: A61M 2205/8206 : battery-operated
• CPC Class Codes: A61M 2205/8237 : Charging means
• CPC Class Codes: A61M 2206/16 : Rotating swirling helical flow, e.g. by tangential inflows
• CPC Class Codes: A61M 2209/06 : Packaging for specific medical equipment
• CPC Class Codes: A61M 2230/201 : Glucose concentration
• CPC Class Codes: A61M 2230/30 : Blood pressure A61M2230/04 takes precedence

Abstract

A method of flowing a medicament containing powder using gas, including, providing a volume of a gas according to one or more release conditions; directing flow of said gas through or adjacent a powder including a medicament; and releasing a therapeutically effective amount of said powder using said gas. Optionally, the releasing comprises releasing according to breath considerations. Optionally or alternatively, the releasing comprises releasing according to time considerations. In an exemplary embodiment of the invention, the powder is held in a capsule that has apertures formed therein.

Claims

1. A method of flowing a medicament containing powder using gas, comprising:

providing a volume of a gas according to one or more release conditions;

directing flow of said gas through or adjacent a powder including a medicament;

releasing a therapeutically effective amount of said powder using said gas.

2. A method according to claim 1, wherein said releasing comprises releasing according to breath considerations.

3. A method according to claim 2, wherein said breath considerations comprises an inspiratory flow rate.

4. A method according to claim 2, wherein said breath considerations comprises an inspiratory flow volume.

5. A method according to claim 2, wherein said breath considerations comprises a prolonged expiratory phase.

6. A method according to claim 1, wherein said release condition comprises an inspiratory flow rate higher than a threshold.

7. A method according to claim 1, wherein said release condition comprises a delay from the start of an inhalation phase.

8. A method according to claim 7, wherein said delay is less than 1.5 seconds.

9. A method according to claim 1, wherein said release condition comprises a time or a volume before an inert part.

10. A method according to claim 9, wherein said inert part ranges from 25% to 75% of an inspiratory volume.

11. A method according to claim 1, wherein said releasing comprises releasing according to time considerations.

12. A method according to claim 11, wherein said time considerations comprises a time of day.

13. A method according to claim 1, wherein said releasing comprises releasing in a burst, wherein said burst is less than 0.2 seconds in length.

14. A method according to claim 1, wherein said releasing comprises releasing continuously, wherein said continuously is between 0.5 seconds and 5 seconds in length.

15. A method according to claim 1, wherein said releasing an amount comprises releasing two or more amounts as part of a release logic.

16. A method according to claim 15, wherein said powder comprises one powder source.

17. A method according to claim 15, wherein said two or more amounts are different.

18. A method according to claim 15, wherein said two or more amounts are equal.

19. A method according to claim 15, wherein a first amount is released during a morning and a second amount is released during an afternoon.

20. A method according to claim 15, wherein said two or more amounts are dynamically adjusted according to a feedback.

21. A method according to claim 20, wherein said dynamically adjusted comprises dynamically adjusting in real time.

22. A method according to claim 20, wherein said dynamically adjusted comprises dynamically adjusting per breath.

23. A method according to of claim 1, wherein said release condition comprises an external reference.

24. A method according to claim 1, wherein said providing comprises providing by dynamically adjusting said volume.

25. A method according to claim 1, wherein said providing comprises providing by dynamically adjusting a pressure of said gas.

26. A method according to claim 1, wherein said releasing comprises inhaling as part of a medical therapy.

27. A method according to claim 1, wherein said releasing comprises blowing into a body cavity.

28. A method according to claim 1, further comprising:

providing said powder in a capsule; and

opening said capsule, and wherein said directing flow comprises directing through said opening.

29. A method according to claim 1, wherein said flow deagglomerates said powder.

30. A method according to claim 1, wherein said flow aerosolizes said powder.

31. A method according to claim 13, wherein said gas is compressed before a second of said burst

50. A method according to claim 1, further comprising:

providing a first amount of said powder in a capsule;

forming one or more apertures in said capsule; and

controlling the release of a second amount of said powder from said capsule, wherein said second amount is less than said first amount.

51. A method according to claim 50, wherein said second amount is released from the same capsule as said first amount.

52. A method according to claim 1, further comprising:

releasing a therapeutically effective first amount of said powder during a breathing cycle; and

releasing a therapeutically effective second amount of said powder during said breathing cycle, wherein said first and second amounts are separated by a period of time.

53. A method according to claim 52, wherein said releasing comprises releasing by flowing a gas through said powder.

58. A method according to claim 1, further comprising:

estimating a breathing pattern for release of a dry powder including a medicament;

comparing said estimated pattern to an actual breathing pattern during said release; and

providing feedback to improve said breathing pattern.

59. A method according to claim 58, wherein said comparing comprises comparing in real time.

32. A dry powder delivery apparatus for delivery of a medicament to a target location, comprising:

a source of a gas;

a dry powder including a medicament;

a staging chamber configured to allow one or more bursts of said gas through or adjacent said powder, thereby releasing a therapeutically effective amount of said powder, said one or more burst of said gas are configured so that said released powder will use inspiratory effort to reach said target location of a patient;

a sensor configured to sense a parameter of said inspiratory breathing;

a controller configured to analyze said sensed inspiratory parameter against an inhalation parameter that will potentially provide powder delivery to a target tissue; and

an output interface configured to provide output according to said analysis.

33. An apparatus according to claim 32, wherein said gas is a volume of a gas.

34. An apparatus according to claim 32, further comprising a compressor.

35. An apparatus according to claim 34, further comprising a piston to compress said gas in a cylinder.

36. An apparatus according to claim 32, further comprising a tank to store said gas.

37. An apparatus according to claim 32, further comprising a handpump to compress said gas.

38. An apparatus according to claim 32, further comprising at least one capsule comprising said powder, wherein said capsule is positioned in said staging chamber.

39. An apparatus according to claim 38, further comprising a magazine of said capsules comprising said powder.

40. An apparatus according to claim 38, further comprising a piercing mechanism to pierce one or more holes in said capsule.

41. An apparatus according to claim 32, further wherein said controller is configured to control the release of said gas through said chamber.

42. An apparatus according to claim 41, wherein said controller is configured to control the release of said powder according to a treatment protocol.

43. An apparatus according to claim 41, wherein said controller is configured to dynamically control the release of said powder according to a feedback.

44. An apparatus according to claim 32, further comprising a facemask, said facemask in fluid communication with said staging chamber.

45. An apparatus according to claim 32, further comprising a safety mechanism to restrict access to said powder.

46. An apparatus according to claim 45, wherein said safety mechanism prevents access to said powder.

47. An apparatus according to claim 45, wherein said safety mechanism disposes of said powder.

48. An apparatus according to claim 32, further comprising two or more separately stored types of a dry powder.

49. An apparatus according to claim 32, wherein said apparatus is self powered.

60. An apparatus according to claim 32, wherein said sensor is a flow sensor configured to sense an inspiratory flow rate.

61. An apparatus according to claim 32 wherein said analysis comprises one of:

an inspiratory flow rate being too slow, said flow rate being too fast, or said flow rate is proper breathing.

62. An apparatus according to claim 32 wherein said releasing comprises releasing an amount of said powder smaller than the total amount of said dry powder in a capsule.

63. An apparatus according to claim 32 wherein said releasing comprises releasing said dry powder over at least one of a plurality of inspiratory breaths and a prolonged period of time.

54. A dry powder delivery kit for delivery of a medicament, comprising:

a container for positioning one or more capsules comprising a dry powder including a medicament in an apparatus;

a battery for providing power to said apparatus; and

a facemask.

55. An apparatus according to claim 54 further comprising:

a dry powder delivery apparatus for delivery of a medicament.

56. An apparatus according to claim 54, further comprising:

a mouth adapter, said mouth adapter provides a fluid communication between said apparatus and a mouth.

57. An apparatus according to of claim 54, further comprising:

a nasal adapter, said nasal adapter provides a fluid communication between said apparatus and a nostril.

64. A method of delivering a dry powder medicament to a target location, comprising:

releasing a therapeutically effective amount of a dry powder including a medicament from a staging chamber using a source of a gas, so that said released powder will use inspiratory effort to reach said target location of a patient;

sensing a parameter of said inspiratory breathing;

analyzing said sensed parameter against an inhalation parameter that will potentially provide powder delivery to said target location; and

providing output according to said analysis.

65. A method according to claim 64, further comprising:

piercing a capsule comprising said dry powder to form one or more apertures;

selecting said gas according to a size of said apertures, so that said dry powder is deagglomerated to a preselected average particle size.