POWDER DELIVERY DEVICES

• US 20090293873A1
• Filed: 02/23/2006
• Published: 12/03/2009
• Est. Priority Date: 02/23/2005
• Status: Active Grant

• Current Assignee: OptiNose, Inc.
• Original Assignee: OptiNose AS (OptiNose, Inc.)
• Inventors: Hafner, Roderick Peter, Sheldrake, Colin David, Djupesland, Per Gisle
• Granted Patent: US 8,899,229 B2
• Time in Patent Office: Days
• US Class Current: 128/203.15
• 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 15/0041 with movable piercing or cutting means
• CPC Class Codes: A61M 15/0086 Inhalation chambers
• CPC Class Codes: A61M 15/0098 Activated by exhalation
• CPC Class Codes: A61M 15/08 Inhaling devices inserted into the nose
• CPC Class Codes: A61M 16/0066 Blowers or centrifugal pumps
• CPC Class Codes: A61M 16/105 Filters A61M16/047, A61M16/22 take precedence; water traps A61M16/08
• CPC Class Codes: A61M 16/1075 by influencing the temperature A61M16/1045 takes precedence
• CPC Class Codes: A61M 16/127 by Venturi effect, i.e. entrainment mixers
• CPC Class Codes: A61M 2016/0021 with a proportional output signal, e.g. from a thermistor
• CPC Class Codes: A61M 2016/0027 pressure meter
• CPC Class Codes: A61M 2202/064 Powder
• CPC Class Codes: A61M 2205/07 having air pumping means
• CPC Class Codes: A61M 2205/076 mouth operated
• CPC Class Codes: A61M 2205/3606 cooled
• CPC Class Codes: A61M 2205/3673 thermo-electric, e.g. Peltier effect, thermocouples, semi-conductors
• CPC Class Codes: A61M 2205/8218 Gas operated
• CPC Class Codes: A61M 2206/14 : Static flow deviators in tubes disturbing laminar flow in tubes, e.g. archimedes screws
• CPC Class Codes: A61M 2210/0618 : Nose
• CPC Class Codes: A61M 2210/0625 : Mouth

Abstract

A nasal delivery device for delivering substance to a nasal cavity of a subject, the delivery device comprising: a substance supply unit for supplying a dose of substance to be delivered to the nasal cavity of the subject, she substance supply unit including an inlet and an outlet; a nosepiece unit including a nosepiece for fitting to a nasal cavity of the subject and being in fluid communication with the outlet of the substance supply unit; and a mouthpiece unit including a mouthpiece in fluid communication with the inlet of the substance supply unit and through which the subject in use exhales such as to entrain substance from the container chamber and deliver the same through the nosepiece, and at least one temperature modifier for reducing a temperature of the exhaled air flow such as to reduce the absolute humidity thereof.

Claims

1. A nasal delivery device for delivering substance to a nasal cavity of a subject, the delivery device comprising:

a substance supply unit for supplying a dose of substance to be delivered to the nasal cavity of the subject, the substance supply unit including an inlet and an outlet;

a nosepiece unit including a nosepiece for fitting to a nasal cavity of the subject and being in fluid communication with the outlet of the substance supply unit; and

a mouthpiece unit including a mouthpiece in fluid communication with the inlet of the substance supply unit and through which the subject in use exhales such as to entrain substance from the substance supply unit and deliver the same through the nosepiece, and at least one temperature modifier for reducing a temperature of the exhaled air flow such as to reduce the absolute humidity thereof.

2. The delivery device of claim 1, wherein the at least one temperature modifier comprises at least one elongate channel.

3. The delivery device of claim 2, wherein the at least one temperature modifier comprises a plurality of elongate channels.

4. The delivery device of claim 2, wherein the mouthpiece unit includes a plurality of temperature modifiers which can be fluidly connected successively to the mouthpiece, and a switching mechanism which allows for one of the temperature modifiers to be fluidly connected to the mouthpiece.

5. The delivery device of claim 4, wherein, when the one of the temperature modifiers is fluidly connected to the mouthpiece, the at least one other temperature modifier is vented to atmosphere.

6. The delivery device of claim 4, wherein the switching mechanism comprises a rotatable member to which the temperature modifiers are disposed, whereby rotation of the switching mechanism provides for the one of the temperature modifiers to be in fluid communication with the mouthpiece.

7. The delivery device of claim 1, wherein the substance supply unit comprises a container chamber for receiving a substance-containing container which contains a dose of substance.

8. The delivery device of claim 7, wherein the container chamber is substantially cylindrical in shape.

9. The delivery device of claim 7, wherein the container chamber is substantially spherical in shape.

10. The delivery device of claim 7, wherein the container chamber and the nosepiece comprise a unitary, replaceable component.

11. The delivery device of claim 7, wherein the substance supply unit comprises a rupturing mechanism for rupturing the container as contained in the container chamber.

12. The delivery device of claim 7, wherein the container is formed of a material which exhibits insufficient tackiness in the presence of moisture such as not to adhere to an inner surface of the container chamber during emptying of the container.

13. The delivery device of claim 12, wherein the container is formed of a material which exhibits insufficient tackiness in the presence of moisture in the exhalation air flow for a period of up to about 5 s, preferably up to about 2 s and more preferably up to about 1 s following exhalation.

16. The delivery device of claim 7, wherein the container is formed substantially of a cellulose derivative, and preferably the container is formed substantially of one of hydroxypropyl methylcellulose (HPMC), hydroxypropylcellulose, methylcellulose, ethylcellulose and carboxymethylcellulose.

18. The delivery device of claim 7, wherein the container is formed substantially of gelatine.

19. The delivery device of claim 7, wherein the container is formed of a plastics material.

20. The delivery device of claim 7, wherein the container includes a coating of a material which exhibits insufficient tackiness in the presence of moisture such as not to adhere to an inner surface of the container chamber during emptying of the container.

21. The delivery device of claim 20, wherein the coating is formed of a material which exhibits insufficient tackiness in the presence of moisture in the exhalation air flow for a period of up to about 5 s, preferably up to about 2 s and more preferably up to about 1 s following exhalation.

24. The delivery device of claim 20, wherein the coating comprises substantially one of parylene, hydroxypropyl methylcellulose (HPMC), hydroxypropylcellulose, methylcellulose, ethylcellulose, carboxymethylcellulose, polyvinyl alcohol, acrylic acid polymer, methacrylic acid polymer, ethyl acrylic acid polymer, cellulose acetate phthalate, polyvinyl acetate phthalate, hydroxypropyl methylcellulose phthalate and hydroxyl methylcellulose acetate succinate, or any combination of layers thereof.

25. The delivery device of claim 20, wherein the container comprises a body of gelatine.

26. The delivery device of claim 7, wherein the container comprises a capsule.

27. The delivery device of claim 26, wherein the capsule is substantially cylindrical in shape.

28. The delivery device of claim 26, wherein the capsule is substantially spherical in shape.

29. The delivery device of claim 1, wherein the at least one temperature modifier is configured to reduce the temperature of the exhaled air flow by more than about 5°

C., and preferably by at least about 12°

C.

31. The delivery device of claim 1, wherein the at least one temperature modifier is configured to allow a flow therethrough at a flow rate of at least about 10 l/min, preferably at least about 20 l/min, more preferably at least about 30 l/min, still more preferably at least about 40 l/min and yet still more preferably at least about 50 l/min at a pressure of less than about 2 kPa, and preferably less than about 1 kPa.

36. The delivery device of claim 1, wherein the at least one temperature modifier is configured such as to provide a pressure drop of not more than about 0.5 kPa, preferably not more than about 0.25 kPa, more preferably not more than about 0.10 kPa, still more preferably not more than about 0.05 kPa and yet still more preferably not more than about 0.025 kPa to the exhaled air flow.

41. The delivery device of claim 1, wherein the at least one temperature modifier comprises a thermoelectric device.

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42. A nasal delivery device for delivering substance to a nasal cavity of a subject, the delivery device comprising:

a substance supply unit for supplying a dose of substance to be delivered to the nasal cavity of the subject, the substance supply unit comprising a substance-receiving chamber including an inlet and an outlet, and a Venturi unit for drawing a flow of ambient air through the substance-receiving chamber;

a nosepiece unit including a nosepiece for fitting to the nasal cavity of the subject and being in fluid communication with the Venturi unit; and

a mouthpiece unit including a mouthpiece in fluid communication with the Venturi unit and through which the subject in use exhales such as to entrain substance from the substance-receiving chamber and deliver the same through the nosepiece.

43. The delivery device of claim 42, wherein the substance-receiving chamber comprises a container chamber for receiving a substance-containing container which contains a dose of substance.

44. The delivery device of claim 43, wherein the container chamber is substantially cylindrical in shape.

45. The delivery device of claim 43, wherein the container chamber is substantially spherical in shape.

46. The delivery device of claim 43, wherein the container chamber and the nosepiece comprise a unitary, replaceable component.

47. The delivery device of claim 43, wherein the substance supply unit comprises a rupturing mechanism for rupturing the substance-containing container as contained in the container chamber.

48. The delivery device of claim 43, wherein the container is formed of a material which exhibits insufficient tackiness in the presence of moisture such as not to adhere to an inner surface of the container chamber during emptying of the container.

49. The delivery device of claim 48, wherein the container is formed of a material which exhibits insufficient tackiness in the presence of moisture in the exhalation air flow for a period of up to about 5 s, preferably up to about 2 s and more preferably up to about 1 s following exhalation.

52. The delivery device of claim 43, wherein the container is formed substantially of a cellulose derivative, and preferably the container is formed substantially of one of hydroxypropyl methylcellulose (HPMC), hydroxypropylcellulose, methylcellulose, ethylcellulose and carboxymethylcellulose.

54. The delivery device of claim 43, wherein the container is formed substantially of gelatine.

55. The delivery device of claim 43, wherein the container is formed of a plastics material.

56. The delivery device of claim 43, wherein the container includes a coating of a material which exhibits insufficient tackiness in the presence of moisture such as not to adhere to an inner surface of the container chamber during emptying of the container.

57. The delivery device of claim 56, wherein the coating is formed of a material which exhibits insufficient tackiness in the presence of moisture in the exhalation air flow for a period of up to about 5 s, preferably up to about 2 s and more preferably up to about 1 s following exhalation.

60. The delivery device of claim 56, wherein the coating comprises substantially one of parylene, hydroxypropyl methylcellulose (HPMC), hydroxypropylcellulose, methylcellulose, ethylcellulose, carboxymethylcellulose, polyvinyl alcohol, acrylic acid polymer, methacrylic acid polymer, ethyl acrylic acid polymer, cellulose acetate phthalate, polyvinyl acetate phthalate, hydroxypropyl methylcellulose phthalate and hydroxyl methylcellulose acetate succinate, or any combination of layers thereof.

61. The delivery device of claim 56, wherein the container comprises a body of gelatine.

62. The delivery device of claim 43, wherein the container comprises a capsule.

63. The delivery device of claim 62, wherein the capsule is substantially cylindrical in shape.

64. The delivery device of claim 62, wherein the capsule is substantially spherical in shape.

65. The delivery device of claim 42, wherein the Venturi unit comprises a first, driving air flow inlet which is in fluid communication with the mouthpiece unit and provides a constriction which acts to accelerate the exhaled air flow to deliver a driving air flow at a higher velocity, a second, substance air flow inlet which is in fluid communication with the substance supply unit and through which is in use drawn a substance air flow from the substance-receiving chamber which entrains substance as contained therein, and an air flow outlet which is in fluid communication with the nosepiece unit and through which the driving air flow and the substance air flow are in use delivered.

66. The delivery device of claim 65, wherein the driving air flow is directed substantially perpendicularly to the substance air flow.

67. The delivery device of claim 65, wherein the driving air flow is directed substantially parallel to the substance air flow.

68. The delivery device of claim 42, wherein the mouthpiece unit is fluidly connected to the substance supply unit, such as to provide a supplemental air flow to the substance-receiving chamber on exhalation by the subject into the mouthpiece unit.

69. The delivery device of claim 68, wherein the mouthpiece unit includes a flow channel which is fluidly connected to the inlet of the substance-receiving chamber.

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70. A nasal delivery device for delivering substance to a nasal cavity of a subject, the delivery device comprising:

a substance supply unit for supplying a dose of substance to be delivered to the nasal cavity of the subject, the substance supply unit comprising a substance-receiving chamber including an inlet and an outlet, and a gas supply unit for delivering a gas flow through the substance-receiving chamber such as in use to provide a gas flow entraining substance from the outlet of the substance-receiving chamber;

a nosepiece unit including a nosepiece for fitting to the nasal cavity of the subject and being in fluid communication with the outlet of the substance-receiving chamber; and

a mouthpiece unit including a mouthpiece in fluid communication with the outlet of the substance-receiving chamber and the nosepiece and through which the subject in use exhales such as to entrain substance as delivered from the substance-receiving chamber and deliver the same through the nosepiece.

71. The delivery device of claim 70, wherein the substance-receiving chamber comprises a container chamber for receiving a substance-containing container which contains a dose of substance.

72. The delivery device of claim 71, wherein the container chamber is substantially cylindrical in shape.

73. The delivery device of claim 71, wherein the container chamber is substantially spherical in shape.

74. The delivery device of claim 71, wherein the container chamber and the nosepiece comprise a unitary, replaceable component.

75. The delivery device of claim 71, wherein the substance supply unit comprises a rupturing mechanism for rupturing the container as contained in the container chamber.

76. The delivery device of claim 71, wherein the container is formed of a material which exhibits insufficient tackiness in the presence of moisture such as not to adhere to an inner surface of the container chamber during emptying of the container.

77. The delivery device of claim 76, wherein the container is formed of a material which exhibits insufficient tackiness in the presence of moisture in the exhalation air flow for a period of up to about 5 s, preferably up to about 2 s and more preferably up to about 1 s following exhalation.

80. The delivery device of claim 71, wherein the container is formed substantially of a cellulose derivative, and preferably the container is formed substantially of one of hydroxypropyl methylcellulose (HPMC), hydroxypropylcellulose, methylcellulose, ethylcellulose and carboxymethylcellulose.

82. The delivery device of claim 71, wherein the container is formed substantially of gelatine.

83. The delivery device of claim 71, wherein the container is formed of a plastics material.

84. The delivery device of claim 71, wherein the container includes a coating of a material which exhibits insufficient tackiness in the presence of moisture such as not to adhere to an inner surface of the container chamber during emptying of the container.

85. The delivery device of claim 84, wherein the coating is formed of a material which exhibits insufficient tackiness in the presence of moisture in the exhalation air flow for a period of up to about 5 s, preferably up to about 2 s and more preferably up to about 1 s following exhalation.

88. The delivery device of claim 84, wherein the coating comprises substantially one of parylene, hydroxypropyl methylcellulose (HPMC), hydroxypropylcellulose, methylcellulose, ethylcellulose, carboxymethylcellulose, polyvinyl alcohol, acrylic acid polymer, methacrylic acid polymer, ethyl acrylic acid polymer, cellulose acetate phthalate, polyvinyl acetate phthalate, hydroxypropyl methylcellulose phthalate and hydroxyl methylcellulose acetate succinate, or any combination of layers thereof.

89. The delivery device of claim 84, wherein the container comprises a body formed substantially of gelatine.

90. The delivery device of claim 71, wherein the container comprises a capsule.

91. The delivery device of claim 90, wherein the capsule is substantially cylindrical in shape.

92. The delivery device of claim 90, wherein the capsule is substantially spherical in shape.

93. The delivery device of claim 70, wherein the gas supply unit comprises a volume of pressurized gas which, when released, provides the entraining gas flow.

94. The delivery device of claim 70, wherein the gas supply unit comprises a charged turbine which, when released, provides the entraining gas flow.

95. The delivery device of claim 70, wherein the gas supply unit is a breath-actuated unit.

96. The delivery device of claim 95, wherein the gas supply unit is actuated in response to generation of a predeterminable flow rate through the mouthpiece unit.

97. The delivery device of claim 95, wherein the gas supply unit is actuated in response to generation of a predeterminable pressure at the mouthpiece unit.

98. The delivery device of claim 70, wherein the gas supply unit is a manually-actuated unit.

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99. A capsule for containing a powdered substance which exhibits insufficient tackiness, and preferably no surface tackiness, in the presence of moisture such as not to adhere to an inner surface of a capsule chamber which contains the capsule during emptying of the capsule.

100. The capsule of claim 99, where formed of a material which exhibits insufficient tackiness in the presence of moisture in an exhalation air flow for a period of up to about 5 s.

101. The capsule of claim 100, where formed of a material which exhibits insufficient tackiness in the presence of moisture in the exhalation air flow for a period of up to about 2 s.

102. The capsule of claim 100, where formed of a material which exhibits insufficient tackiness in the presence of moisture in the exhalation air flow for a period of up to about 1 s.

103. The capsule of claim 99, where formed substantially of a cellulose derivative.

104. The capsule of claim 103, where formed substantially of one of hydroxypropyl methylcellulose (HPMC), hydroxypropylcellulose, methylcellulose, ethylcellulose and carboxymethylcellulose.

105. The capsule of claim 99, where formed of a plastics material.

106. The capsule of claim 99, where including a coating of a material which exhibits insufficient tackiness in the presence of moisture such as not to adhere to an inner surface of the capsule chamber during emptying of the capsule.

107. The capsule of claim 106, wherein the coating is formed of a material which exhibits insufficient tackiness in the presence of moisture in an exhalation air flow for a period of up to about 5 s.

108. The capsule of claim 107, wherein the coating is formed of a material which exhibits insufficient tackiness in the presence of moisture in the exhalation air flow for a period of up to about 2 s.

109. The capsule of claim 108, wherein the coating is formed of a material which exhibits insufficient tackiness in the presence of moisture in the exhalation air flow for a period of up to about 1 s.

110. The capsule of claim 106, wherein the coating comprises substantially one of parylene, hydroxypropyl methylcellulose (HPMC), hydroxypropylcellulose, methylcellulose, ethylcellulose, carboxymethylcellulose, polyvinyl alcohol, acrylic acid polymer, methacrylic acid polymer, ethyl acrylic acid polymer, cellulose acetate phthalate, polyvinyl acetate phthalate, hydroxypropyl methylcellulose phthalate and hydroxyl methylcellulose acetate succinate, or any combination of layers thereof.

111. The capsule of claim 106, where comprising a body formed substantially of gelatine.

112. The capsule of claim 102, wherein the capsule is substantially cylindrical in shape.

113. The capsule of claim 102, wherein the capsule is substantially spherical in shape.

114. The capsule of claim 102, where comprising a body of thin-wall section.

115. The capsule of claim 114, wherein the body has a thickness of not more than about 0.25 mm.

116. The capsule of claim 115, wherein the body has a thickness of not more than about 0.20 mm.

117. A capsule containing a powdered substance which exhibits insufficient tackiness, and preferably no surface tackiness, in the presence of moisture such as not to adhere to an inner surface of a capsule chamber which contains the capsule during emptying of the capsule in an exhaled air flow, wherein the capsule comprises a body formed substantially of hydroxypropyl methyl cellulose (HPMC) and a coating substantially of parylene.

132. The capsule of claim 117, wherein the body is of thin-wall section.

133. The capsule of claim 132, wherein the body has a thickness of not more than about 0.25 mm.

134. The capsule of claim 133, wherein the body has a thickness of not more than about 0.20 mm.

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135. A nasal delivery device for delivering substance to a nasal cavity of a subject, the delivery device comprising:

a substance supply unit for supplying a dose of substance to be delivered to the nasal cavity of the subject, the substance supply unit including an inlet and an outlet;

a nosepiece unit including a nosepiece for fitting to a nasal cavity of the subject and being in fluid communication with the outlet of the substance supply unit; and

a mouthpiece unit including a mouthpiece in fluid communication with the inlet of the substance supply unit and through which the subject in use exhales such as to entrain substance from the substance supply unit and deliver the same through the nosepiece.

136. A method of delivering substance to a nasal cavity of a subject, the method comprising the steps of:

supplying a dose of substance to be delivered to the nasal cavity of the subject;

fitting a nosepiece unit including a nosepiece to the nasal cavity of the subject; and

the subject exhaling through a mouthpiece unit such as to entrain the supplied dose of substance and deliver the same through the nosepiece to the nasal cavity of the subject, wherein the mouthpiece unit includes at least one temperature modifier for reducing a temperature of the exhaled air flow such as to reduce the absolute humidity thereof.

137. A method of delivering substance to a nasal cavity of a subject, the method comprising the steps of:

providing a dose of substance to be delivered to the nasal cavity of the subject in a substance-receiving chamber;

fitting a nosepiece unit including a nosepiece to the nasal cavity of the subject;

providing a Venturi unit which is operative to draw a flow of ambient air through the substance-receiving chamber; and

the subject delivering an exhaled air flow to the Venturi unit such as to draw a flow of ambient air through the substance-receiving chamber which entrains the powdered substance therein, and to the nosepiece such as to deliver the exhaled air flow entraining the powdered substance to the nasal cavity of the subject.

138. A method of delivering substance to a nasal cavity of a subject, the method comprising the steps of:

providing a dose of substance to be delivered to the nasal cavity of the subject in a substance-receiving chamber;

fitting a nosepiece unit including a nosepiece to the nasal cavity of the subject;

providing a gas flow of ambient air through the substance-receiving chamber, which entrains the powdered substance therein; and

the subject delivering an exhaled air flow to the nosepiece which entrains the gas flow entraining the powdered substance, such as to deliver the powdered substance to the nasal cavity of the subject.