Inhaler

• US 20040050385A1
• Filed: 09/10/2003
• Published: 03/18/2004
• 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: Davies, Michael Birsba, Bonney, Stanley George
• Application Number:
  US10/399,674
• Publication Number:
  US 20040050385A1
• Time in Patent Office: Days
• US Class Current: 128/203.15
• CPC Class Codes: A61M 15/0043 Non-destructive separation of the package, e.g. peeling
• 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 15/007 Mechanical counters
• CPC Class Codes: A61M 15/009 using medicine packages with incorporated spraying means, e.g. aerosol cans pocket atomiser of the injector type A61M11/08
• CPC Class Codes: A61M 2016/0021 with a proportional output signal, e.g. from a thermistor
• CPC Class Codes: A61M 2016/0039 in the inspiratory circuit
• CPC Class Codes: A61M 2202/062 Desiccants
• 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 2205/8206 battery-operated
• CPC Class Codes: A61M 2209/06 Packaging for specific medical equipment

Abstract

The invention provides an inhaler for delivery of a dry powder medicament, the inhaler comprising a breath sensor for sensing the breath of a patient; means for transporting the medicament to a delivery position; and electro-mechanical coupling means for actuating said transport means, wherein said coupling means is directly or indirectly responsive to the breath sensor.

Claims

1. An inhaler device for delivery of a metered dose of dry powder medicament, the inhaler comprising a breath sensor for sensing the breath of a patient;

means for transporting the medicament dose to a delivery position; and

electro-mechanical coupling means for actuating said transport means to transport the medicament dose to said delivery position, wherein said coupling means is directly or indirectly responsive to the breath sensor.

2. An inhaler according to claim 1 wherein the medicament is pre-metered prior to actuation of the inhaler by the patient.

3. An inhaler according to claim 1 or claim 2 further comprising a reservoir for said dry powder and a meter for metering an amount of dry powder from said reservoir.

4. An inhaler according to claim 3 wherein the breath sensor actuates said meter.

5. An inhaler according to claim 4 wherein the coupling means is responsive to said meter.

6. An inhaler according to any one of the preceding claims further comprising release means.

7. An inhaler according to claim 6 wherein the release means is actuable by the coupling means and/or the meter and/or the transport means.

8. An inhaler according to any one of the preceding claims wherein the dose-release means comprises (i) a passive and/or (ii) an active dose-release mechanism.

9. An inhaler according to claim 8 wherein the passive dose-release mechanism comprises making the metered dose available to the patient for inhalation thereby.

10. An inhaler according to claim 8 or claim 9 wherein the active dose-release mechanism comprises means to propel pressurised gas in the direction of patient inhalation.

11. An inhaler according to claim 10 wherein the gas-propelling means provides at least one pulse of gas on actuation.

12. An inhaler according to claim 10 or 11 wherein the gas-propelling means provides one pulse of gas for each dose dispensed.

13. An inhaler according to any one of claims 10 to 12 wherein the gas is air.

14. An inhaler according to any one of claims 10 to 12 wherein the gas is an inert gas.

15. An inhaler according to any one of the preceding claims 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.

16. An inhaler according to any one of the preceding claims 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.

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

18. An inhaler according to claim 17 wherein on actuation of the meter, the or each metering chamber moves into fluid communication with the reservoir.

19. An inhaler according to claim 17 or claim 18 wherein the meter and the reservoir are relatively rotatable with respect to each other about a common central axis.

20. An inhaler according to claim 19 wherein the or each metering chamber is adapted to be in fluid communication selectively with the reservoir or with the patient.

21. An inhaler according to any one of claims 17 to 20 wherein the or each metering chamber has a variable volume.

22. An inhaler according to any one of claims 17 to 20 wherein the or each metering chamber has a fixed volume which metering volume is variable by insertion of a plunger or piston.

23. An inhaler according to claim 21 wherein the or each metering chamber is formed from expandable material.

24. An inhaler according to claim 21 wherein the or each metering chamber has a telescopic or concertina arrangement.

25. An inhaler according to any one of claims 17 to 24 further comprising a gas permeable dry powder retaining means below the or each metering chamber.

26. An inhaler according to claim 25 wherein the retaining means is made from a gas-permeable filter, a mesh screen, a porous material or a perforated chamber element.

27. An inhaler according to any one of claims 6 to 26, additionally comprising a reset mechanism for resetting the meter and/or the transport means and/or the release means after actuation thereof.

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

29. An inhaler according to claim 28 wherein the climate control means is actuable by the coupling means and/or the transport means and/or the release means.

30. An inhaler according to claim 28 or claim 29 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.

31. An inhaler according to any one of claims 28 to 30 wherein the climate control means comprises a desiccant.

32. An inhaler according to any one of claims 28 to 31 wherein the climate control means comprises a heater.

33. An inhaler according to claim 32 wherein the heater dries the meter prior to metering of the dose and/or immediately after the dose is dispensed.

34. An inhaler according to any one of claims 28 to 33 wherein the climate control means comprises a temperature and/or a moisture sensor.

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

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

37. 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.

38. An inhaler according to claim 37, additionally comprising a reset coupling which is reversibly deformable in response to heating thereof or application of a magnetic field thereto.

39. An inhaler according to claims 37 or 38, wherein the heating is achievable by electric current flow through the coupling.

40. An inhaler according to any of claims 37 to 39, wherein the coupling comprises a wire, strip, coil or tube.

41. An inhaler according to claim 40, wherein the coupling comprises multiple wires, strips, coils or tubes.

42. An inhaler according to any of claims 37 to 41, wherein the coupling comprises one or more wires which contract in response to heating or application of a magnetic field thereto.

43. An inhaler according to claim 42, wherein the coupling exhibits a degree of contraction of from 2% to 8% on heating or application of a magnetic field thereto.

44. An inhaler according to claim 43, wherein the coupling comprises an alloy which undergoes a phase transition on heating or application of a magnetic field thereto.

45. An inhaler according to claim 44, wherein the alloy is a nickel-titanium alloy.

46. An inhaler according to claim 45, 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.

47. An inhaler according to either of claims 45 or 46, wherein the nickel-titanium alloy additionally comprises copper, niobium or any mixtures thereof.

48. An inhaler according to claim 44, wherein the alloy is a copper-zinc-aluminium alloy or a copper-aluminium-nickel alloy.

49. An inhaler according to claim 44, 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 %.

50. An inhaler according to claim 44, 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.

51. An inhaler according to any of claims 40 to 50, wherein the one or more wires have a diameter from 30 to 400 micrometers, preferably from 50 to 150 micrometers.

53. An inhaler according to claim 40 or 41, wherein said strip comprises multiple layers of different metals.

54. An inhaler according to claim 53, wherein the strip comprises a bimetallic strip.

55. An inhaler according to either of claims 53 or 54, wherein the strip comprises at least one piezoelectric material.

56. An inhaler according to any of claims 37 to 55, wherein the coupling is deformable in response to heating arising from electrical current flow in the range from 0.01A to 100A, preferably from 0.1A to 5A.

57. An inhaler according to any of claims 37 to 55, wherein the coupling is deformable in response to a magnetic field of from 0.01 to 100 Tesla.

58. 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.

59. An inhaler according to claim 58 wherein the trigger point is during the inhalation or exhalation stage of the patient'"'"'s breath cycle.

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

61. An inhaler according to claim 60, wherein the breath-movable element is selected from the group consisting of a vane, a sail, a piston, a diaphragm and an impeller.

62. 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.

63. 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.

64. 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.

65. 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.

66. 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.

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

68. An inhaler according to claim 67 wherein the electronic information processor actuates the meter at a predetermined trigger point in the breath cycle.

69. An inhaler as claimed in claim 68 wherein the electronic information processor includes an active memory for storing information about the breath cycle.

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

71. An inhaler according to claim 68 wherein the electronic information processor includes a look up table for predicting the optimum trigger point.

72. An inhaler according to any one of claims 69 to 71 wherein the electronic information processor includes a second predictive algorithm for predicting the optimum amount of medicament to release.

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

74. An inhaler according to claim 69 to 73 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.

75. An inhaler according to claims 69 to 74 additionally comprising a display for displaying information about the optimum amount of medicament to release.

76. An inhaler according to any one of claims 67 to 75 additionally comprising a selector for selecting the amount of medicament to release.

77. An inhaler according to claim 76 wherein the selector is manually operable.

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

79. An inhaler according to claim 76 to 78 wherein the selector comprises a timing mechanism for varying the time interval of activation of the inhaler.

80. An inhaler according to any one of claims 76 to 79 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.

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

82. An inhaler according to claim 81, wherein the electrical energy source comprises a voltaic cell or battery of voltaic cells.

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

84. An inhaler according to claim 81, wherein the electrical energy source comprises a photovoltaic cell or battery of photovoltaic cells.

85. An inhaler according to claim 81, wherein the electrical energy source comprises a converter for converting mechanical energy into electrical energy.

86. An inhaler according to any of claims 81 to 85, additionally comprising a controller for controlling the amount of electrical current flow through the coupling or to an electromagnet.

87. An inhaler according to any of claims 81 to 86, additionally comprising a timer for controlling the duration of electrical current flow through the coupling or to an electromagnet.

88. An inhaler according to any of claims 81 to 87 additionally comprising a local electrical energy store.

89. An inhaler according to any one of claims 81 to 88 wherein the additional energy source is mechanically-generated.

90. An inhaler according to claim 89 wherein the energy source comprises a biasable resilient member.

91. An inhaler according to claim 90 wherein the biasable resilient member is a spring.

92. An inhaler according to claim 89 wherein the energy source comprises a source of compressed fluid, preferably compressed gas.

93. An inhaler according to claim 89 wherein the energy source comprises a chemical energy store, preferably a chemical propellant or ignition mixture.

94. An inhaler according to claim 89 wherein the energy source comprises a physically explosive energy source.

95. 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.

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

97. 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.

98. 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.

99. 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 transport means and/or dose-release means or a dose counter for counting the number of doses delivered.

100. An inhaler according to claim 99, wherein the actuation counter is independent of the coupling between the breath sensor and the transport means and optionally dose-release means.

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

103. An inhaler according to any of the preceding claims comprising a manual override enabling manual actuation of the transport means.

104. An inhaler according to claim 103 comprising a child resistance feature to prevent undesirable actuation thereof by children.

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

110. Kit of parts comprising an inhaler according to any of claims 1 to 104 in the form of a cartridge;

and a housing shaped for receipt of the cartridge.

52. An inhaler according to any of 40 to 51, 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.

102. An inhaler according to claim wherein the safety mechanism imposes a time delay between successive actuation of the inhaler.

106. An actuator for a dry powder medicament container having a meter, the actuator comprising a dispenser seat for receipt of the meter, a breath sensor, and transport means, wherein the transport means is electro-mechanically actuable by the breath sensor and/or the meter.

107. An actuator according to claim 106 further comprising release means.

108. An actuator according to claim 106 or 107 wherein the breath sensor is linkable to the transport means and/or dose-release means via coupling means.

109. An actuator according to claim 108 wherein the coupling means is reversibly deformable in response to heating thereof or application of a magnetic field thereto.

111. A method for the delivery of a metered dose of dry powder medicament to a patient comprising:

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

(ii) transporting the medicament dose to a delivery position by use of transport means; and

optionally

(iv) releasing the medicament dose for inhalation by the patient by the use of dose-release means,

wherein electro-mechanical coupling means actuate said transport means and optionally said release means, and said coupling means is directly or indirectly responsive to the breath sensor.

112. A method as claimed in claim 111 wherein the medicament is pre-metered prior to actuation of the inhaler by the patient.

113. A method according to claim 111 or claim 112 further comprising metering a volume of dry powder from a medicament reservoir after sensing the breath of a patient and prior to transporting the medicament to a delivery position.

114. A method according to claim 113 wherein the metering step is actuable by the breath sensor.