Atomising devices and methods

• US 5,497,944 A
• Filed: 11/19/1992
• Issued: 03/12/1996
• Est. Priority Date: 03/21/1990
• Status: Expired due to Term

• Current Assignee: Boehringer Ingelheim International GmbH (C.H. Boehringer Sohn AG & Co. KG)
• Original Assignee: DMW (Technology) Limited
• Inventors: Dunne, Stephen T., Weston, Terence E.
• Primary Examiner(s): Kashnikow, Andres
• Application Number:
  US07/938,174
• Time in Patent Office: 1,209 Days
• Field of Search: 239/321, 239/518, 239/524, 239/543, 239/544, 222/321, 222/383, 222/384, 222/340, 222/341, 222/49, 222/321.1, 222/321.6-321.9, 222/383.1, 222/321.2
• US Class Current: 239/321
• CPC Class Codes: A61M 11/001 Particle size control
• 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: B05B 1/26 with means for mechanically breaking-up or deflecting the jet after discharge, e.g. with fixed deflectors; Breaking-up the discharged liquid or other fluent material by impinging jets
• CPC Class Codes: B05B 1/265 the liquid or other fluent material being symmetrically deflected about the axis of the nozzle
• CPC Class Codes: B05B 1/3436 the interface being a plane perpendicular to the outlet axis
• CPC Class Codes: B05B 11/0041 compensating underpressure without contact of the fluid remaining in the container with the atmospheric air B05B11/026 and B05B11/028 take precedence
• CPC Class Codes: B05B 11/026 Membranes separating the content remaining in the container from the atmospheric air to compensate underpressure inside the container
• CPC Class Codes: B05B 11/1001 Piston pumps B05B11/1087, B05B11/1088, B05B11/109 take precedence
• CPC Class Codes: B05B 11/1074 located outside pump chambers
• CPC Class Codes: B05B 11/1091 being first hold in a loaded state by locking means or the like, then released B05B11/1092 takes precedence
• CPC Class Codes: B05B 15/40 Filters located upstream of the spraying outlets
• CPC Class Codes: B05B 9/0883 having a discharge device fixed to the container
• CPC Class Codes: G01F 11/025 with manually operated pistons G01F19/005 takes precedence

Abstract

A metered dose inhaler for dispensing a fluid medicament as droplets of small mean particle size without the use of pressurized gas or liquefied propellants. A liquid drug is contained in a fluid reservoir, and metered quantities of the drug are successively presented into a reduced cross-section pressure chamber, with non-return valves controlling the flow of liquid through the device. The metered quantity of the drug is then subjected to a sudden and great increase in pressure by releasing a piston into the pressure chamber. The liquid drug is thereby ejected through an atomizing head, to reduce it to a fine atomized spray of small mean particle size, preferably less than approximately 12 micrometers.

Claims

1. A device for dispensing a metered quantity of fluid as a spray of droplets by discharging the metered quantity of fluid under pressure through an atomising means, comprising:

a chamber for containing said metered quantity of fluid at a first pressure;

an energy storage means for retaining and applying a predetermined amount of energy to said chamber so as to subject said metered quantity of fluid to a predetermined increase in pressure from said first pressure to a second pressure of at least 50 bar to permit discharge of said metered quantity of fluid from said chamber at said second pressure; and

atomising means for atomising said fluid discharged from said chamber, said atomising means comprising an outlet aperture having a hydraulic diameter of 100 micrometers or less, whereby said fluid is atomized into droplets having a mean size suitable for inhalation into the lungs.

2. A device according to claim 1, further comprising:

a conduit connecting said chamber and said atomising means; and

a valve mechanism for regulating the flow of fluid between said chamber and said atomising means.

3. A device according to claim 2 wherein said hydraulic diameter is of suitable size for formation of droplets having a mean size of less than 10 micrometers.

4. A device according to claim 2, wherein said valve mechanism comprises a pressure release valve.

5. A device according to claim 1, further comprising:

latching means to retain said energy storage means in a state retaining said predetermined amount of energy; and

actuation means for releasing said predetermined amount of energy from said energy storage means.

6. A device according to claim 1, wherein said first pressure is substantially ambient pressure.

7. A device according to claim 1, wherein said outlet aperture has a hydraulic diameter of up to 50 micrometers.

8. A device according to claim 1, wherein said second pressure is in the range of approximately 100 bar to approximately 350 bar.

9. A device according to claim 8, wherein said hydraulic diameter is in the range of 1 to 12 micrometers.

10. A device according to claim 9, wherein said hydraulic diameter is in the range of 2 to 6 micrometers.

11. A device according to claim 1, wherein said energy storage means comprises a piston adapted to act directly on said chamber to pressurize said metered quantity of fluid.

12. A device according to claim 11, wherein said piston comprises a hollow channel in fluid communication with said chamber.

13. A device according to claim 12, further comprising:

a nor-return inlet valve for said chamber disposed within said channel.

14. A device according to claim 12, further comprising:

a fluid reservoir in fluid communication with said channel, wherein said piston extends from said fluid reservoir.

15. A device according to claim 1, wherein said hydraulic diameter is of suitable size for formation of droplets having a mean size of less than 10 micrometers.

16. A device according to claim 15, wherein said hydraulic diameter is of suitable size for formation of droplets having a mean size in the range of 2 to 6 micrometers.

17. A device according to claim 1, wherein said energy storage means comprises a pump having a piston and a spring, said chamber defined by a cylinder space in said pump beyond said piston.

18. A device according to claim 17, wherein said pump is provided with a latching mechanism whereby said pump can be held in a cocked state prior to release of the energy from said spring.

19. A device according to claim 1, further comprising:

a non return inlet valve in fluid communication with said chamber; and

a non-return outlet valve in fluid communication with said chamber to permit repeated charge of fluid into said chamber and discharge of fluid from said chamber.

20. A device according to claim 1, further comprising:

a fluid reservoir in fluid communication with said chamber from which said chamber can be charged with fluid.

21. A device according to claim 20, wherein said fluid reservoir is removable.

22. A device according to claim 20, wherein said reservoir is collapsible.

23. A device according to claim 1, wherein said second pressure is in the range of approximately 300 bar to approximately 500 bar.

24. A device for dispensing a metered quantity of fluid as a spray of droplets by discharging the metered quantity of fluid under pressure through an atomising means, comprising:

a chamber for containing said metered quantity of fluid at a first pressure;

an energy storage means for retaining and applying a predetermined amount of energy to said chamber so as to subject said metered quantity of fluid to a predetermined increase in pressure from said first pressure to a second pressure of 50 bar or more to permit discharge of said metered quantity of fluid from said chamber at said second pressure; and

atomising means for atomising said fluid from said chamber comprising an outlet aperture having a hydraulic diameter of 100 micrometers or less and configured so that said fluid forms a jet of fluid, and an impingement body located in the line of trajectory of said jet, said impingement body adapted to cause break up of said jet into a spray of droplets, said droplets having a mean size suitable for inhalation into the lungs.

25. A device according to claim 24, wherein said second pressure is in the range of approximately 100 bar to approximately 350 bar and wherein said hydraulic diameter is in the range of 1 to 12 micrometers.

26. A device according to claim 25, wherein said hydraulic diameter is in the range of 2 to 6 micrometers.

44. A device according to claim 24, further comprising:

a fluid reservoir in fluid communication with said chamber from which said chamber car be charged with fluid.

45. A device according to claim 44, wherein said fluid reservoir is removable.

46. A device according to claim 44, wherein said reservoir is collapsible.

49. A method according to claim 45, wherein said energy storage means comprises a pump having a piston and a spring, said chamber defined by a cylinder space in said pump beyond said piston.

50. A method according to claim 49, wherein said pump is provided with a latching mechanism whereby said pump can be held in a cocked state prior to release of the energy from said spring.

27. A device for dispensing a metered quantity of fluid as a spray of droplets by discharging the metered quantity of fluid under pressure through an atomising means, comprising:

a chamber for containing said metered quantity of fluid at a first pressure;

an energy storage means for retaining and applying a predetermined amount of energy to said chamber so as to subject said metered quantity of fluid to a predetermined increase in pressure from said first pressure to a second pressure of 50 bar or more to permit discharge of said metered quantity of fluid from said chamber at said second pressure; and

atomising means for atomising said fluid from said chamber comprising a plurality of outlet apertures, each of said plurality of outlet apertures having a hydraulic diameter of 100 micrometers or less and configured so that said fluid forms a plurality of jets of fluid, said plurality of jets of fluid impinging upon one another to form a spray of droplets, said droplets having a mean size suitable for inhalation into the lungs.

28. A device according to claim 27, wherein said second pressure is in the range of approximately 100 bar to approximately 350 bar and wherein each of said plurality of outlet apertures has a hydraulic diameter in the range of 1 to 12 micrometers.

29. A device according to claim 28, wherein each of said plurality of outlet apertures has a hydraulic diameter in the range of 2 to 6 micrometers.

30. A device for dispensing a metered quantity of fluid as a spray of fine droplets by discharging the metered quantity of fluid under pressure through an atomizing means, comprising:

a chamber for containing said metered quantity of fluid at a first pressure;

an energy storage means for retaining and applying a predetermined amount of energy to said chamber so as to subject said metered quantity of fluid to a predetermined increase in pressure from said first pressure to a second pressure of at least about 100 bar to permit discharge of said metered quantity of fluid from said chamber at said second pressure; and

atomizing means for atomizing said fluid discharged from said chamber, said atomizing means comprising an outlet aperture having a hydraulic diameter suitable for formation of atomized droplets having a mean size of less than 10 micrometers for inhalation into the lungs.

31. A device according to claim 30, wherein said hydraulic diameter is suitable for formation of atomized droplets having a mean size in the range of 2 to 6 micrometers.

37. A device according to claim 31, wherein said second pressure is 100 bar or greater.

38. A device according to claim 37, wherein said hydraulic diameter is of suitable size for formation of droplets having a mean size of less than 10 micrometers.

32. A device for discharging a metered quantity of fluid as a spray of droplets by discharging the metered quantity of fluid under pressure through an atomising means, comprising:

a chamber for containing said metered quantity of fluid at a first pressure;

an energy storage means;

means for applying a predetermined amount of energy to said energy storage means;

means for releasing said predetermined amount of energy from said energy storage means to said chamber so as to subject said fluid to a predetermined increase in pressure to a second pressure and to initiate discharge of said fluid from said chamber; and

atomising means for receiving said metered quantity of pressurized fluid from said chamber as a single discharge from said chamber, and for atomising said metered quantity of fluid, said atomising means comprising an outlet aperture having a hydraulic diameter of 100 micrometers or less whereby said fluid is atomized into droplets having a mean size suitable for inhalation into the lungs.

33. A device according to claim 32, wherein said second pressure is 50 bar or greater.

34. A device according to claim 33, wherein said hydraulic diameter is of suitable size for formation of droplets having a mean size of less than 10 micrometers.

35. A device according to claim 34, wherein said hydraulic diameter of said outlet aperture is 50 micrometers or less.

36. A device according to claim 34, wherein said hydraulic diameter is of suitable size for formation of droplets having a mean size in the range of 2 to 6 micrometers.

39. A device according to claim 32, wherein said hydraulic diameter is of suitable size for formation of droplets having a mean size of less than 10 micrometers.

40. A device according 16 claim 39, wherein said hydraulic diameter is of suitable size for formation of droplets having a mean size in the range of 2 to 6 micrometers.

41. A device according to claim 32, further comprising:

a conduit connecting said chamber and said atomising means; and

a valve mechanism for regulating the flow of fluid between said chamber and said atomising means.

42. A device according to claim 41, wherein said valve mechanism comprises a pressure release valve.

43. A device according to claim 32, further comprising:

a non return inlet valve in fluid communication with said chamber; and

a non-return outlet valve in fluid communication with said chamber to permit repeated charge of fluid into said chamber and discharge of fluid from said chamber.

47. A method of discharging a metered quantity of fluid as a spray of droplets by discharging the metered quantity of fluid under pressure through an atomising means, comprising the steps of:

providing said metered quantity of fluid in a chamber at which said fluid is held at a first pressure;

applying a predetermined amount of energy to an energy storage means;

releasing said predetermined amount of energy from said energy storage means to said chamber so as to subject said fluid to a predetermined increase in pressure to a second pressure and to initiate discharge of said fluid from said chamber; and

discharging said metered quantity of pressurized fluid from said chamber as a single discharge from said chamber through an outlet aperture in the atomising means, said outlet aperture having a hydraulic diameter of 100 micrometers or less, thereby atomising said fluid into droplets having a mean size suitable for inhalation into the lungs.

48. A method according to claim 47, wherein said second pressure is from 50 to 500 bar and wherein said discharging step produces droplets having a mean size of less than 10 micrometers.

51. A method according to claim 47, wherein said droplets have a mean size in the range of 1 to 12 micrometers.

52. A method according to claim 51, wherein said droplets have a mean size in the range of 2 to 6 micrometers.

53. A method of discharging a metered quantity of fluid as a spray of droplets by discharging the metered quantity of fluid under pressure through an atomising means, comprising the steps of:

providing said metered quantity of fluid in a chamber at which said fluid is held at a first pressure;

applying a predetermined amount of energy to an energy storage means;

releasing said predetermined amount of energy from said energy storage means to said chamber so as to subject said fluid to a predetermined increase in pressure from said first pressure to a second pressure of at least 50 bar; and

discharging said fluid from said chamber through an outlet aperture in the atomising means, said outlet aperture having a hydraulic diameter of 100 micrometers or less, thereby atomising said fluid into droplets having a mean size suitable for inhalation into the lungs.

54. A method according to claim 53, wherein said droplets have a mean size in the range of 1 to 12 micrometers.

55. A metered dose inhaler for supplying fluid medicament to the lungs, comprising:

a chamber for containing a metered quantity of fluid medicament at a first pressure;

an energy storage means for retaining and applying a predetermined amount of energy to said chamber so as to subject said metered quantity to a predetermined increase in pressure from said first pressure to a second pressure of at least 50 bar to permit discharge of said metered quantity from said chamber at said second pressure, said energy storage means comprising a piston adapted to act directly on said chamber to pressurize said metered quantity, a spring, and a latching mechanism whereby said energy storage means can be held in a cocked state prior to release of the energy from said spring; and

atomising means for atomising said metered quantity discharged from said chamber, said atomising means comprising a first outlet aperture having a hydraulic diameter of 100 micrometers or less.

56. A metered dose inhaler according to claim 55, further comprising:

a non-return inlet valve, wherein said piston comprises a hollow channel in fluid communication with said chamber, said non-return inlet valve disposed within said channel; and

a fluid reservoir in fluid communication with said channel, wherein said piston extends from said fluid reservoir.

57. A metered dose inhaler according to claim 56, wherein said latching mechanism is released to initiate discharge of said metered quantity from said chamber at said second pressure, wherein said second pressure is in excess of 100 bar.

58. A metered dose inhaler according to claim 56, wherein said atomising means further comprises:

a second outlet aperture, wherein a first jet of said metered quantity is discharged through said first outlet aperture and a second jet of said metered quantity is discharged through said second outlet aperture, said first jet and said second jet impinging upon one another to form a spray of droplets.

59. A-metered dose inhaler according to claim 56, wherein said second pressure is in excess of 100 bar.

60. A metered dose inhaler according to claim 55, wherein said latching mechanism is released to initiate discharge of said metered quantity from said chamber at said second pressure.

61. A metered dose inhaler according to claim 60, wherein the second pressure is in excess of 100 bar.

62. A metered dose inhaler according to claim 60, wherein said atomising means further comprises:

a second outlet aperture, wherein a first jet of said metered quantity is discharged through said first outlet, aperture and a second jet of said metered quantity is discharged through said second outlet aperture, said first jet and said second jet impinging upon one another to form a spray of droplets.

63. A metered dose inhaler according to claim 55, wherein said second pressure is in excess of 100 bar.

64. A metered dose inhaler according to claim 55, wherein said atomising means further comprises:

a second outlet aperture, wherein a first jet of said metered quantity is discharged through said first outlet aperture and a second jet of said metered quantity is discharged through said second outlet aperture, said first jet and said second jet impinging upon one another to form a spray of droplets.

65. A device for dispensing a metered quantity of fluid as a spray of droplets by discharging the metered quantity of fluid under pressure through an atomising means, comprising:

a chamber for containing said metered quantity of fluid at a first pressure;

an energy storage means for retaining and applying a predetermined amount of energy to said chamber so as to subject said metered quantity of fluid to a predetermined increase in pressure from said first pressure to a second pressure of at least 50 bar to permit discharge of said metered quantity of fluid from said chamber at said second pressure; and

atomising means for atomising said fluid discharged from said chamber, said atomising means comprising an outlet aperture having a hydraulic diameter of suitable size for formation of droplets having a mean size of less than 10 micrometers for inhalation into the lungs.

66. A device according to claim 65, further comprising:

a conduit connecting said chamber and said atomising means; and

a valve mechanism for regulating the flow of fluid between said chamber and said atomising means.

67. A device according to claim 65, further comprising:

latching means to retain said energy storage means in a state retaining said predetermined amount of energy; and

actuation means for releasing said predetermined amount of energy from said energy storage means.

68. A device according to claim 65, wherein said first pressure is substantially ambient pressure.

69. A device according to claim 65, wherein said second pressure is in the range of approximately 100 bar to approximately 350 bar.

70. A device according to claim 65, wherein said energy storage means comprises a piston adapted to act directly on said chamber to pressurize said metered quantity of fluid.

71. A device according to claim 70, wherein said piston comprises a hollow channel in fluid communication with said chamber.

72. A device according to claim 71, further comprising:

a non-return inlet valve for said chamber disposed within said channel.

73. A device according to claim 71, further comprising:

a fluid reservoir in fluid communication with said channel, wherein said piston extends from said fluid reservoir.

74. A device according to claim 65, wherein said second pressure is in the range of approximately 300 bar to approximately 500 bar.

75. A method of discharging a metered quantity of fluid as a spray of droplets by discharging the metered quantity of fluid under pressure through an atomising means, comprising the steps of:

providing said metered quantity of fluid in a chamber at which said fluid is held at a first pressure;

applying a predetermined amount of energy to an energy storage means;

releasing said predetermined amount of energy from said energy storage means to said chamber so as to subject said fluid to a predetermined increase in pressure from said first pressure to a second pressure of at least 50 bar; and

discharging said fluid from said chamber through an outlet aperture in the atomising means, said outlet aperture having a hydraulic diameter of suitable size for formation of droplets having a mean size of less than 10 micrometers, thereby atomising said fluid into droplets having a mean size suitable for inhalation into the lungs.

76. A device for discharging a metered quantity of fluid as a spray of droplets by discharging the metered quantity of fluid under pressure through an atomising means, comprising:

a chamber for containing said metered quantity of fluid at a first pressure;

an energy storage means;

means for applying a predetermined amount of energy to said energy storage means;

means for releasing said predetermined amount of energy from said energy storage means to said chamber so as to subject said fluid to a predetermined increase in pressure to a second pressure to permit discharge of said metered quantity of fluid from said chamber at said second pressure; and

atomising means for receiving said metered quantity of pressurized fluid from said chamber, and for atomising said metered quantity of fluid, said atomising means comprising an outlet aperture having a hydraulic diameter of 100 micrometers or less whereby said fluid is atomized into droplets having a mean size suitable for inhalation into the lungs.