Medicament dispenser

• US 20030005926A1
• Filed: 06/10/2002
• Published: 01/09/2003
• Est. Priority Date: 12/11/1999
• Status: Active Grant

• Current Assignee: Smithkline Beecham Corporation (GSK plc)
• Original Assignee: Smithkline Beecham Corporation (GSK plc)
• Inventors: Rand, Paul Kenneth, Robertson, Duncan, Jones, Anthony Patrick
• Granted Patent: US 7,322,355 B2
• Time in Patent Office: Days
• US Class Current: 128/200.23
• CPC Class Codes: A61M 15/0023 retractable
• 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 15/0043 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 15/0065 Inhalators with dosage or measuring devices A61M15/0028 takes precedence; dosage devices incorporated in aerosol cans B65D83/52
• CPC Class Codes: A61M 15/0068 Indicating or counting the number of dispensed doses or of remaining doses
• CPC Class Codes: A61M 15/008 Electronic 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 15/0091 mechanically breath-triggered
• 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 2205/332 Force measuring means
• CPC Class Codes: A61M 2205/3584 using modem, internet or bluetooth
• CPC Class Codes: A61M 2205/6054 Magnetic identification systems
• CPC Class Codes: A61M 2205/8206 battery-operated
• CPC Class Codes: A61M 2205/8212 with means or measures taken for minimising energy consumption
• CPC Class Codes: A61M 2205/825 using mechanical generation of electricity, e.g. hand cranked generators

Abstract

There is provided a medicament dispenser comprising a body, a medicament container and reset means for resetting a mechanical mechanism after actuation thereof, wherein the reset means comprises a reset coupling. The coupling is reversibly deformable in response to the application of non-mechanical energy thereto. The non-mechanical energy may comprise heat energy, electrical current energy, electrical field energy or magnetic field energy.

Claims

1. A medicament dispenser comprising a body, a medicament container and reset means for resetting a mechanical mechanism after actuation thereof, wherein the reset means comprises a reset coupling which is reversibly deformable in response to the application of non-mechanical energy thereto.

2. A medicament dispenser according to claim 1 wherein the mechanical mechanism is selected from one or more of the following:

(i) trigger means;

(ii) dose-metering means;

(iii) transport means;

(iv) dose-liberating means;

(v) exit channel-exposing means.

3. A medicament dispenser according to claim 2 wherein the trigger means directly or indirectly actuates the dose-liberating means.

4. A medicament dispenser according to claim 2 or claim 3 wherein the dose-liberating means takes the form of a valve and/or dose-metering means, and/or aerosolization means, and/or container-opening means, and/or a pump (e.g. an aqueous pump), and/or a plunger (e.g. as in an automated syringe).

5. A medicament dispenser according to claim 4 wherein the dose-metering means comprises a weight and/or a volume and/or a time and/or a surface-area regulated mechanism.

6. A medicament dispenser according to claim 5 wherein dose-metering means comprises a valve (for example, a linear or rotary valve) and/or a piston and/or a load cell and/or a plunger.

7. A medicament dispenser according to any one of claims 4 to 6 wherein the dose-metering means comprises at least one metering chamber.

8. A medicament dispenser according to claim 7 wherein on actuation of the dose-metering means, the or each metering chamber moves into fluid communication with the reservoir.

9. A medicament dispenser according to claim 7 or claim 8 wherein the dose-metering means and the reservoir are relatively rotatable with respect to each other about a common central axis.

10. A medicament dispenser according to claim 9 wherein the or each metering chamber is adapted to be in fluid communication selectively with the reservoir or with the patient.

11. A medicament dispenser according to any one of claims 7 to 10 wherein the or each metering chamber has a variable volume.

12. A medicament dispenser according to any one of claims 7 to 10 wherein the or each metering chamber has a fixed volume which metering volume is variable by insertion of a plunger or piston.

13. A medicament dispenser according to claim 11 wherein the or each metering chamber is formed from expandable material.

14. A medicament dispenser according to claim 11 wherein the or each metering chamber has a telescopic or concertina arrangement.

15. A medicament dispenser according to any one of claims 7 to 14 further comprising a gas permeable dry powder retaining means below the or each metering chamber.

16. A medicament dispenser according to claim 15 wherein the retaining means is made from a gas-permeable filter, a mesh screen, a porous material or a perforated chamber element.

17. A medicament dispenser according to claim 2 wherein the aerosolization means comprises a container of compressed gas (e.g. an inert gas or air), or a liquefied propellant under pressure.

18. A medicament dispenser according to claim 17 wherein the aerosolization means comprises means to propel pressurised gas through a metered dose.

19. A medicament dispenser according to claim 18 wherein the gas-propelling means provides at least one pulse of gas on actuation.

20. A medicament dispenser according to claim 18 or 19 wherein the gas-propelling means provides one pulse of gas for each dose dispensed.

21. A medicament dispenser according to any one of claims 18 to 20 wherein the gas is air.

22. A medicament dispenser according to any one of claims 18 to 20 wherein the gas is an inert gas.

23. A medicament dispenser according to any one of claims 17 to 22 wherein the aerosolization means liberates a pre-metered dose of medicament for receipt by a patient.

24. A medicament dispenser according to claim 2 wherein the transport means transports an amount of medicament from a rest position to a delivery position.

25. A medicament dispenser according to claim 24 wherein the transport means comprises a perforated strip and claw advancement mechanism and/or a ratchet wheel and a driving pawl advancement mechanism.

26. A medicament dispenser according to any of claims 1 to 25, wherein said non-mechanical energy comprises electric current flow through the coupling.

27. A medicament dispenser according to any of claims 1 to 26, wherein the coupling comprises a wire, strip, coil or tube.

28. A medicament dispenser according to claim 27, wherein the coupling comprises multiple wires, strips, coils or tubes.

29. A medicament dispenser according to any of claims 1 to 28, wherein the coupling comprises one or more wires which contract in response to the application of non-mechanical energy thereto.

30. A medicament dispenser according to claim 29, wherein the coupling exhibits a degree of contraction of from 2% to 8% on application of non-mechanical energy thereto.

31. A medicament dispenser according to claim 30, wherein the coupling comprises an alloy which undergoes a phase transition on application of non-mechanical energy thereto.

32. A medicament dispenser according to claim 31, wherein said alloy is a nickel-titanium alloy.

33. A medicament dispenser according to claim 32, 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.

34. A medicament dispenser according to either of claims 32 or 33, wherein said nickel-titanium alloy additionally comprises copper, niobium or any mixtures thereof.

35. A medicament dispenser according to claim 31, wherein the alloy is a copper-zinc-aluminium alloy or a copper-aluminium-nickel alloy.

36. A medicament dispenser according to claim 31, wherein the alloy has the composition defined as Ni₆₅₋

x−

yMn₂₀+xGa₁₅+y, where x is between 3 atomic % and 15 atomic % and y is between 3 atomic % and 12 atomic %.

37. A medicament dispenser according to claim 31, wherein the alloy has the composition defined as (Ni_aFe_bCo_c)₆₅₋

x−

y(Mn_dFe_eCo_f)₂₀+x(Ga_gSi_hAl_l)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.

38. A medicament dispenser according to claim 31, wherein the alloy comprises an ion-exchange polymer composite.

39. A medicament dispenser according to claim 31, wherein the alloy comprises a contractile polymer.

40. A medicament dispenser according to any of claims 29 to 39, wherein said one or more wires have a diameter from 30 to 400 micrometers, preferably from 50 to 150 micrometers.

41. A medicament dispenser according to any of claims 29 to 40, wherein the coupling comprises from two to twenty, preferably six to twelve wires which contract in response to heating or application of a magnetic field thereto.

42. A medicament dispenser according to any of claims 1 to 41, wherein said strip comprises multiple layers of different metals.

43. A medicament dispenser according to claim 42, wherein the strip comprises a bimetallic strip.

44. A medicament dispenser according to either of claims 42 or 43, wherein the strip comprises at least one piezoelectric material.

45. A medicament dispenser according to any of claims 1 to 44, 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.

46. A medicament dispenser according to any of claims 1 to 44, wherein the coupling is deformable in response to a magnetic field of from 0.01 to 100 Tesla.

47. A medicament dispenser according to any of claims 1 to 46, additionally comprising an electrical energy source.

48. A medicament dispenser according to claim 47, wherein said electrical energy source comprises a voltaic cell or battery of voltaic cells.

49. A medicament dispenser according to claim 48, wherein said voltaic cell or battery of voltaic cells is rechargeable.

50. A medicament dispenser according to claim 47, wherein said electrical energy source comprises a photovoltaic cell or battery of photovoltaic cells.

51. A medicament dispenser according to claim 47, wherein said electrical energy source comprises a converter for converting mechanical energy into electrical energy.

52. A medicament dispenser according to any of claims 47 to 51, additionally comprising a controller for controlling the amount of electrical current flow through the coupling or to an electromagnet to provide a magnetic field.

53. A medicament dispenser according to any of claims 47 to 52, additionally comprising a timer for controlling the duration of electrical current flow through the coupling or to an electromagnet to provide a magnetic field.

54. A medicament dispenser according to any of claims 47 to 53 additionally comprising a local electrical energy source.

55. A medicament dispenser according to any one of claims 47 to 54 wherein the additional energy source is mechanically-generated.

56. A medicament dispenser according to claim 55 wherein the energy source comprises a biasable resilient member.

57. A medicament dispenser according to claim 56 wherein the biasable resilient member is a spring.

58. A medicament dispenser according to claim 55 wherein the energy source comprises a source of compressed fluid, preferably compressed gas.

59. A medicament dispenser according to claim 55 wherein the energy source comprises a chemical energy store, preferably a chemical propellant or ignition mixture.

60. A medicament dispenser according to claim 55 wherein the energy source comprises a physically explosive energy source.

61. A medicament dispenser according to any of claims 1 to 60, wherein flow of electrical current through the coupling and hence, actuation of the reset means is responsive to a patient-actuable mechanism.

62. A medicament dispenser according to claim 61, wherein said mechanism comprises a button, switch or lever arrangement.

63. A medicament dispenser according to any of claims 1 to 62, in the form of an inhaler for the delivery of inhalable medicament.

64. A medicament dispenser according to claim 63, wherein heating arising from flow of electrical current through the coupling and hence, actuation of the reset means is responsive to a patient-actuable mechanism comprising a sensor which senses the breath of a patient.

65. A medicament dispenser according to claim 64, wherein said sensor comprises a breath-movable element which is movable in response to the breath of a patient.

66. A medicament dispenser according to claim 65, wherein said breath-movable element is selected from the group consisting of a vane, a sail, a piston, a diaphragm and an impeller.

67. A medicament dispenser according to claim 64, wherein said sensor comprises a pressure sensor for sensing the pressure profile associated with the breath of a patient.

68. A medicament dispenser according to claim 64, wherein said sensor comprises an airflow sensor for sensing the airflow profile associated with the breath of a patient.

69. A medicament dispenser according to claim 64, wherein said sensor comprises a temperature sensor for sensing the temperature profile associated with the breath of a patient.

70. A medicament dispenser according to claim 64, wherein said sensor comprises a moisture sensor for sensing the moisture profile associated with the breath of a patient.

71. A medicament dispenser according to claim 64, wherein said sensor comprises a gas sensor for sensing the oxygen or carbon dioxide profile associated with the breath of a patient.

72. A medicament dispenser according to any of claims 63 to 71, wherein the coupling is exposable to the airflow arising from inhalation or expiration of the patient to assist in the cooling of the coupling post-actuation of the reset means.

73. A medicament dispenser according to any of claims 1 to 72 comprising an actuation counter for counting the number of actuations of the reset means or a dose counter for counting the number of doses delivered.

74. A medicament dispenser according to claim 73, wherein the actuation counter is independent of the coupling.

75. A medicament dispenser according to any of claims 1 to 74 additionally comprising an electronic control system for controlling the supply of non-mechanical energy to the coupling.

76. A medicament dispenser according to claim 75, wherein the electronic control system is capable of providing pulses of non-mechanical energy to the coupling.

77. A medicament dispenser according to either of claims 75 or 76, wherein the electronic control system is capable of receiving inputs from electronic sensors locatable on the dispenser.

78. A medicament dispenser according to claim 77, additionally comprising an electronic sensor selected from the group consisting of a breath sensor, a shake sensor, a temperature sensor, an infrared sensor and a patient ID sensor.

79. A medicament dispenser according to any one of the preceding claims additionally comprising climate control means.

80. A medicament dispenser according to claim 79 wherein the climate control means is actuable by the coupling.

81. A medicament dispenser according to claim 79 or claim 80 wherein the climate control means comprises means to (i) reduce moisture increase in the dispenser;

and/or (ii) maintain ambient temperature; and

/or (iii) dry the dispenser prior to actuation thereof.

82. A medicament dispenser according to any one of claims 79 to 81 wherein the climate control means comprises a desiccant.

83. A medicament dispenser according to any one of claims 79 to 82 wherein the climate control means comprises a heater.

84. A medicament dispenser according to any one of claims 79 to 83 wherein the climate control means comprises a temperature and/or a moisture sensor.

85. A medicament dispenser 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.

86. A medicament dispenser according to any one of the preceding claims wherein the medicament is in dry powder form.

87. A medicament dispenser according to any one of the preceding claims wherein the dry powder medicament includes a pharmaceutical excipient in dry powder form.

88. A medicament dispenser 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.

89. A medicament dispenser according to any one of the preceding claims wherein the dry powder medicament particles are aerodynamically shaped to improve medicament delivery to the patient.

90. A medicament dispenser according to claim 86 wherein the medicament container takes the form of a reservoir for said dry powder and a meter for metering a weight of dry powder from said reservoir.

91. A medicament dispenser according to any one of the preceding claims wherein the medicament is pre-metered prior to actuation of the dispenser by a patient.

92. A medicament dispenser according to any one of the preceding claims wherein the medicament container comprises medicament in solution or suspension form.

93. A medicament dispenser according to claim 92 wherein the medicament container comprises a suspension of a medicament in a propellant, for example, liquefied HFA134a, HFA-227, helium or carbon dioxide.

94. A medicament dispenser according to claim 92 wherein the medicament container comprises a solution of a medicament in a solvent.

95. A medicament dispenser according to any one of the preceding claims additionally comprising a safety mechanism to prevent unintended multiple actuations of the reset means.

97. A medicament dispenser according to any one of the preceding claims comprising a child resistance feature to prevent undesirable actuation thereof by children.

98. A medicament dispenser according to any one of the preceding claims comprising a child resistance feature to prevent undesirable actuation thereof by children.

99. An actuator for use in a medicament dispenser according to any one of the preceding claims.

109. A medicament container for use in the dispenser according to claims 1 to 98 and/or the actuator of claims 99 to 108.

111. Kit of parts comprising a medicament dispenser according to any of claims 1 to 98 in the form of a cartridge;

and a housing shaped for receipt of said cartridge.

96. A medicament dispenser according to claim wherein the safety mechanism imposes a time delay between successive actuation of the reset means.

100. An actuator for a medicament container comprising a housing, within said housing, a container seat for receipt of the medicament container;

on the housing or connecting therewith, reset means to reset a mechanical mechanism, wherein the reset means comprises a reset coupling which is reversibly deformable in response to the application of non-mechanical energy thereto.

101. An actuator according to either of claims 99 or 100, wherein said non-mechanical energy comprises electric current flow through the coupling.

102. An actuator according to any of claims 99 to 101, wherein the coupling comprises one or more wires which contract in response to the application of non-mechanical energy thereto.

103. An actuator according to any of claims 99 to 102, wherein said coupling comprises an alloy which undergoes a phase transition on the application of non-mechanical energy thereto.

104. An actuator according to claim 103, wherein said alloy is a nickel-titanium alloy.

105. An actuator according to any of claims 99 to 104 additionally comprising an electronic control system for controlling the supply of non-mechanical energy to the coupling.

106. An actuator according to claim 105, wherein the electronic control system is capable of providing pulses of non-mechanical energy to the coupling.

107. An actuator according to either of claims 105 or 106, wherein the electronic control system is capable of receiving inputs from electronic sensors locatable on the dispenser.

108. An actuator according to claim 107, additionally comprising an electronic sensor selected from the group consisting of a breath sensor, a shake sensor, a temperature sensor, an infrared sensor and a patient ID sensor.

110. Laboratory test apparatus for testing a medicament container having reset means comprising at least one actuator according to any of claims 99 to 108 and a mounting for said at least one actuator.