Inhaler

• US 20040089299A1
• Filed: 09/09/2003
• Published: 05/13/2004
• Est. Priority Date: 10/20/2000
• Status: Abandoned Application

• Current Assignee: Glaxo Group Limited (Glaxosmithkline Holdings Ltd.)
• Original Assignee: Glaxo Group Limited (Glaxosmithkline Holdings Ltd.)
• Inventors: Bonney, Stanley George, Davies, Michael Birsha
• Application Number:
  US10/399,610
• Publication Number:
  US 20040089299A1
• Time in Patent Office: Days
• US Class Current: 128/203.15
• 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 15/007 Mechanical counters
• CPC Class Codes: A61M 15/008 Electronic counters
• CPC Class Codes: A61M 15/0083 Timers
• CPC Class Codes: A61M 15/02 with activated or ionised fluids, e.g. electrohydrodynamic [EHD] or electrostatic devices; Ozone-inhalators with radioactive tagged particles
• CPC Class Codes: A61M 2016/0039 in the inspiratory circuit
• CPC Class Codes: A61M 2202/064 Powder
• CPC Class Codes: A61M 2205/0266 Shape memory materials
• CPC Class Codes: A61M 2205/3306 Optical measuring means
• CPC Class Codes: A61M 2205/50 with microprocessors or computers
• CPC Class Codes: A61M 2205/8206 battery-operated

Abstract

An inhaler for delivery of a dry powder medicament is disclosed that includes a breath sensor for sensing the breath of a patient, a reservoir for the dry powder, a meter for metering an amount of dry powder from the reservoir, and electro-mechanical coupling means for actuating said meter, wherein said coupling means is directly or indirectly responsive to said breath sensor.

Claims

1. An inhaler for delivery of a dry powder medicament, the inhaler comprising:

a breath sensor for sensing the breath of a patient;

a reservoir for said dry powder;

a meter for metering an amount of dry powder from said reservoir; and

electromechanical coupling means for actuating said meter, wherein said coupling means is directly or indirectly responsive to said breath sensor.

2. An inhaler according to claim 1 wherein the meter comprises a volume and/or a weight and/or a time and/or a surface-area and/or a particle counting regulated mechanism.

3. An inhaler according to claim 1 or claim 2 wherein the meter comprises a valve (for example, a linear or rotary valve) and/or a piston and/or a load cell and/or a plunger.

4. An inhaler according to any one of the preceding claims wherein the meter comprises at least one metering chamber.

5. An inhaler according to claim 4 wherein on actuation of the meter, the or each metering chamber moves into fluid communication with the reservoir.

6. An inhaler according to claim 4 wherein the meter and the reservoir are relatively rotatable with respect to each other about a common central axis.

7. An inhaler according to claim 6 wherein the or each metering chamber is adapted to be in fluid communication selectively with the reservoir or with the patient.

8. An inhaler according to any one of claims 4 to 7 wherein the or each metering chamber has a variable volume.

9. An inhaler according to any one of claims 4 to 7 wherein the or each metering chamber has a fixed volume which metering volume is variable by insertion of a plunger or piston.

10. An inhaler according to any one of claims 4 to 9 wherein the or each metering chamber is formed from expandable material.

11. An inhaler according to any one of claims 4 to 9 wherein the or each metering chamber has a telescopic or concertina arrangement.

12. An inhaler according to any one of claims 4 to 11 further comprising a gas permeable dry powder retaining means below the or each metering chamber.

13. An inhaler according to claim 12 wherein the retaining means is made from a gas-permeable filter, a mesh screen, a porous material or a perforated chamber element.

14. An inhaler according to any one of the preceding claims, additionally comprising a reset mechanism for resetting the meter after actuation thereof.

15. An inhaler according to any one of the preceding claims further comprising transport means to transport the metered volume from the reservoir to a delivery position.

16. An inhaler according to claim 15 wherein the transport means is actuable by the meter.

17. An inhaler according to any one of the preceding claims further comprising dose-release means.

18. An inhaler according to claim 17 wherein the release means is actuable by the coupling means and/or the meter and/or the transport means.

19. An inhaler according to claim 17 or claim 18 wherein the dose-release means comprises (i) a passive and/or (ii) an active dose-release mechanism.

20. An inhaler according to any one of claims 17 to 19 wherein the dose-release mechanism is passive and comprises making the metered volume available to the patient for inhalation thereby.

21. An inhaler according to any one of claims 17 to 19 wherein the dose-release mechanism is active and comprises means to propel pressurised gas in the direction of patient inhalation.

22. An inhaler according to claim 21 wherein the gas-propelling means provides at least one pulse of gas on actuation.

23. An inhaler according to claim 21 or 22 wherein the gas-propelling means provides one pulse of gas for each dose dispensed.

24. An inhaler according to any one of claims 21 to 22 wherein the gas is air.

25. An inhaler according to any one of claims 21 to 23 wherein the gas is an inert gas.

26. An inhaler according to any one of the preceding claims additionally comprising climate control means.

27. An inhaler according to claim 26 wherein the climate control means is actuable by the coupling means and/or the meter and/or the transport means and/or the release means.

28. An inhaler according to claim 27 wherein the climate control means comprises means to (i) reduce moisture increase in the inhaler;

and/or (ii) maintain ambient temperature; and

/or (iii) dry the meter prior to actuation of the inhaler.

29. An inhaler according to any one of claims 26 to 28 wherein the climate control means comprises a desiccant.

30. An inhaler according to any one of claims 26 to 29 wherein the climate control means comprises a heater.

31. An inhaler according to claim 30 wherein the heater dries the meter prior to metering of the volume and/or immediately after the volume is released.

32. An inhaler according to any one of claims 26 to 31 wherein the climate control means comprises a temperature and/or a moisture sensor.

33. An inhaler according to any one of the preceding claims wherein the coupling means comprises a spring and/or a lever.

34. An inhaler according to any one of the preceding claims wherein the coupling means comprises a solenoid.

35. An inhaler as claimed in any one of the preceding claims wherein the coupling means is reversibly deformable in response to heating thereof or application of a magnetic field thereto.

36. An inhaler according to claim 35, additionally comprising a reset coupling which is reversibly deformable in response to heating thereof or application of a magnetic field thereto.

37. An inhaler according to claim 35 or 36, wherein the heating is achievable by electric current flow through the coupling.

38. An inhaler according to any of claims 35 to 37, wherein the coupling comprises a wire, strip, coil or tube.

39. An inhaler according to claim 38, wherein the coupling comprises multiple wires, strips, coils or tubes.

40. An inhaler according to any of claims 35 to 39, wherein the coupling comprises one or more wires which contract in response to heating or application of a magnetic field thereto.

41. An inhaler according to claim 40, wherein the coupling exhibits a degree of contraction of from 2% to 8% on heating or application of a magnetic field thereto.

42. An inhaler according to claim 41, wherein the coupling comprises an alloy which undergoes a phase transition on heating or application of a magnetic field thereto.

43. An inhaler according to claim 42, wherein the alloy is a nickel-titanium alloy.

44. An inhaler according to claim 43, wherein said nickel-titanium alloy comprises from 5% to 95% nickel by weight and from 95% to 5% titanium by weight, preferably from 20% to 80% nickel by weight and from 80% to 20% titanium by weight.

45. An inhaler according to either of claims 43 or 44, wherein the nickel-titanium alloy additionally comprises copper, niobium or any mixtures thereof.

46. An inhaler according to claim 42, wherein the alloy is a copper-zinc-aluminium alloy or a copper-aluminium-nickel alloy.

47. An inhaler according to claim 42, wherein the alloy has the composition defined as Ni_65-x-yMn₂₀+xGa₁₅+y, where x is between 3 atomic % and 15 atomic % and y is between 3 atomic % and 12 atomic %.

48. An inhaler according to claim 42, wherein the alloy has the composition defined as (Ni_aFe_bCo_c)_65-x-y(Mn_dFe_eCo_f)₂₀+x(Ga_gSi_hAl_i)₁₅+y, where x is between 3 atomic % and 15 atomic % and y is between 3 atomic % and 12 atomic %, and where a+b+c=1, where d+e+f=1, and g+h+i=1.

49. An inhaler according to any of claims 38 to 48, wherein the one or more wires have a diameter from 30 to 400 micrometers, preferably from 50 to 150 micrometers.

51. An inhaler according to claim 38 or 39, wherein said strip comprises multiple layers of different metals.

52. An inhaler according to claim 51, wherein the strip comprises a bimetallic strip.

53. An inhaler according to either of claims 51 or 52, wherein the strip comprises at least one piezoelectric material.

54. An inhaler according to any of claims 35 to 53, wherein the coupling is deformable in response to heating arising from electrical current flow in the range from 0.01 A to 100 A, preferably from 0.1 A to 5 A.

55. An inhaler according to any of claims 35 to 53, wherein the coupling is deformable in response to a magnetic field of from 0.01 to 100 Tesla.

56. An inhaler according to any one of the preceding claims wherein the breath sensor electro-mechanically actuates the meter at a predetermined trigger point in the patient'"'"'s breath cycle.

57. An inhaler according to claim 56 wherein the trigger point is during the inhalation or exhalation stage of the patient'"'"'s breath cycle.

58. An inhaler according to any one of the preceding claims wherein the breath sensor comprises a breath-movable element which is movable in response to the breath of a patient.

59. An inhaler according to claim 58, wherein the breath-movable element is selected from the group consisting of a vane, a sail, a piston, a diaphragm and an impeller.

60. An inhaler according to any one of the preceding claims wherein the sensor comprises a pressure sensor for sensing the pressure profile associated with the breath of a patient.

61. An inhaler according to any one of the preceding claims wherein the sensor comprises an airflow sensor for sensing the airflow profile associated with the breath of a patient.

62. An inhaler according to any one of the preceding claims wherein the sensor comprises a temperature sensor for sensing the temperature profile associated with the breath of a patient.

63. An inhaler according to any one of the preceding claims wherein the sensor comprises a moisture sensor for sensing the moisture profile associated with the breath of a patient.

64. An inhaler according to any one of the preceding claims wherein the sensor comprises a gas sensor for sensing the chemical profile, for example, the oxygen or carbon dioxide profile associated with the breath of a patient.

65. An inhaler according to any one of the preceding claims wherein the sensor is connectable to an electronic information processor.

66. An inhaler according to claim 65 wherein the electronic information processor actuates the meter at a predetermined trigger point in the breath cycle.

67. An inhaler as claimed in claim 65 or claim 66 wherein the electronic information processor includes an active memory for storing information about the breath cycle.

68. An inhaler according to claim 65 wherein the electronic information processor includes a predictive algorithm for predicting the optimum trigger point.

69. An inhaler according to claim 65 wherein the electronic information processor includes a look up table for predicting the optimum trigger point.

70. An inhaler according to any one of claims 67 to 69 wherein the electronic information processor includes a second predictive algorithm for predicting the optimum amount of medicament to release.

71. An inhaler according to any one of claims 67 to 69 wherein the electronic information processor includes a second look up table for predicting the optimum amount of medicament to release.

72. An inhaler according to claim 70 or 71 wherein the electronic information processor includes a dose memory for storing information about earlier delivered doses and reference is made to the dose memory in predicting the optimum amount of medicament to release.

73. An inhaler according to claims 70 to 72 additionally comprising a display for displaying information about the optimum amount of medicament to release.

74. An inhaler according to any one of claims 70 to 73 additionally comprising a selector for selecting the amount of medicament to release.

75. An inhaler according to claim 74 wherein the selector is manually operable.

76. An inhaler according to claim 74 wherein the selector is operable in response to a signal from the electronic information processor.

77. An inhaler according to claim 74 to 76 wherein the selector comprises a timing mechanism for varying the time interval of actuation of the dose-metering and/or dose-release means.

78. An inhaler according to any one of claims 74 to 77 wherein the selector comprises a multiple-fire mechanism for multiple actuation of the inhaler wherein each actuation releases a portion of the optimum amount of medicament.

79. An inhaler according to any of the preceding claims, additionally comprising an electrical energy source.

80. An inhaler according to claim 79, wherein the electrical energy source comprises a voltaic cell or battery of voltaic cells.

81. An inhaler according to claim 80, wherein the voltaic cell or battery of voltaic cells is rechargeable.

82. An inhaler according to claim 79, wherein the electrical energy source comprises a photovoltaic cell or battery of photovoltaic cells.

83. An inhaler according to claim 79, wherein the electrical energy source comprises a converter for converting mechanical energy into electrical energy.

84. An inhaler according to any of claims 79 to 83, additionally comprising a controller for controlling the amount of electrical current flow through the coupling or to an electromagnet.

85. An inhaler according to any of claims 79 to 84, additionally comprising a timer for controlling the duration of electrical current flow through the coupling or to an electromagnet.

86. An inhaler according to any of claims 79 to 85 additionally comprising a local electrical energy store.

87. An inhaler according to any one of claims 79 to 86 wherein the additional energy source is mechanically-generated.

88. An inhaler according to claim 87 wherein the energy source comprises a biasable resilient member.

89. An inhaler according to claim 88 wherein the biasable resilient member is a spring.

90. An inhaler according to claim 87 wherein the energy source comprises a source of compressed fluid, preferably compressed gas.

91. An inhaler according to claim 87 wherein the energy source comprises a chemical energy store, preferably a chemical propellant or ignition mixture.

92. An inhaler according to claim 87 wherein the energy source comprises a physically explosive energy source.

93. An inhaler according to any one of the preceding claims wherein the medicament is selected from the group consisting of albuterol, salmeterol, fluticasone propionate, beclomethasone dipropionate, salts or solvates thereof and any mixtures thereof.

94. An inhaler according to any one of the preceding claims wherein the dry powder medicament includes a pharmaceutical excipient in dry powder form.

95. An inhaler according to any one of the preceding claims wherein the density of the dry powder medicament particles is reduced relative to standard dry powder medicament.

96. An inhaler according to any one of the preceding claims wherein the dry powder medicament particles are aerodynamically shaped to improve medicament delivery to the patient.

97. An inhaler according to any one of the preceding claims comprising an actuation counter for counting the number of actuations of the meter and/or dose-releasing means or a dose counter for counting the number of doses delivered.

98. An inhaler according to claim 97, wherein the actuation counter is independent of the coupling between the breath sensor and the meter and/or dose-releasing means.

99. An inhaler according to any one of the preceding claims additionally comprising a safety mechanism to prevent unintended multiple actuations of the inhaler.

100. An inhaler according to any one of the preceding claims wherein the safety mechanism imposes a time delay between successive actuation of the inhaler.

101. An inhaler according to any of the preceding claims comprising a manual override enabling manual actuation of the dose-metering and/or dose-releasing means.

102. An inhaler according to claim 101 comprising a child resistance feature to prevent undesirable actuation thereof by children.

103. An actuator for use in an inhaler according to any one of the preceding claims.

106. A dry powder medicament container having a meter for use in the inhaler according to claims 1 to 102 and/or the actuator of claims 103 to 105.

107. Kit of parts comprising an inhaler according to any of claims 1 to 102 in the form of a cartridge;

and a housing shaped for receipt of the cartridge.

50. An inhaler according to any of 38 to 49, wherein the coupling comprises from two to twelve, preferably six to ten wires which contract in response to heating or application of a magnetic field thereto.

104. An actuator for a dry powder medicament container having a meter for metering a volume of medicament, the actuator comprising a dispenser seat for receipt of the meter, a breath sensor, and an electromechanical coupling means for actuating the meter, wherein the coupling means is responsive to the breath sensor.

105. An actuator according to claim 104 wherein the coupling means is reversibly deformable in response to heating thereof or application of a magnetic field thereto.

108. A method for the delivery of an inhalable dry powder medicament to a patient, comprising:

(i) sensing the breath of a patient by use of a breath sensor;

(ii) at a trigger point, sending an actuation signal from the breath sensor to a meter for metering a volume of medicament from a medicament reservoir; and

(iv) releasing the inhalable medicament for inhalation by the patient, wherein the breath sensor electro-mechanically actuates the meter immediately prior to or concurrent with release of the medicament to the patient.

109. A method according to claim 108 further comprising the actuation of transport means to separate the metered volume from the reservoir and/or dose-release means to release the dose for inhalation by the patient.