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Claims for Patent: 8,215,300

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Claims for Patent: 8,215,300

Title:Unit dose cartridge and dry powder inhaler
Abstract: A dry powder inhaler having improved aerodynamic properties for diluting, dispersing, and metering drug particles for increasing the efficiency of pulmonary drug delivery to a patient is described. The inhaler comprises, in general, a housing having an air intake, an air flow-control/check-valve, a mixing section and a mouthpiece. A cartridge loaded with a single dose of medicament can be installed in the mixing section.
Inventor(s): Steiner; Solomon S. (Mount Kisco, NY), Poole; Trent A. (South Amherst, MA), Fog; Per B. (Bedford Hills, NY), Pohl; Roderike (Sherman, CT), Crick; Michael (Middlebury, CT), Feldstein; Robert (Yonkers, NY)
Assignee: MannKind Corporation (Valencia, CA)
Application Number:12/102,625
Patent Claims: 1. A medicament-dispensing inhaler comprising, in combination, a mouthpiece adapted to deliver airborne medicament to a patient's upper respiratory tract at a position away from the patient's mouth front and upper oropharyngeal region, and a housing, the housing having a mixing cavity adapted to selectively mount a medicament-containing cartridge; and an air-flow cavity for assisting in the delivery of air into and through a cartridge in the mixing cavity and into and through the mouthpiece.

2. An inhaler according to claim 1 further including a cartridge adapted to contain a medicament; adapted to be mounted within the housing mixing cavity; and adapted to be altered in configuration between an open medicament-dispensing configuration and a closed medicament-retaining configuration.

3. An inhaler according to claim 1 further including an air-flow controlling valve mechanism adapted to be mounted within the housing air-flow cavity for assisting in the delivery of an air flow of predetermined velocity and volume into and through the cartridge and mouthpiece.

4. An inhaler according to claim 1 further including a cartridge comprising a first element and a second element, said first element defining an air inlet hole and an air outlet hole, said second element snugly fitted into the first element so as to define, with the first element, a medicament-containing cavity, the second element also defining an air inlet hole and an air outlet hole, the first element and the second element being movable with respect to one another so as to place the air inlet holes in the first element and the second element in registry with one another and to simultaneously place the air outlet holes in the first element and the second element in registry with one another so as to permit a flow of air into, through, and out of the cartridge, the first element and the second element being movable with respect to one another so as to reconfigure the first and second elements thereby placing the inlet and outlet holes out of registry with one another and thereby prohibiting air flow through the cartridge and securely retaining medicament within the cartridge.

5. An inhaler according to claim 1 wherein said mixing cavity includes cartridge mounting mechanism adapted to mate only with a three-dimensional cartridge structure of a pre-determined shape.

6. An inhaler according to claim 1 wherein said mouthpiece comprises a hollow tube having an axis, and wherein said mixing chamber comprises a hollow cylinder having an axis, and wherein the angle defined by the mouthpiece axis and the mixing chamber axis is between about 93 degrees and about 120 degrees.

7. An inhaler according to claim 1 further including mechanism for generating a signal in response to air flow through the inhaler.

8. An inhaler according to claim 1 wherein the mouthpiece has an outer surface and a protrusion on the outer surface adapted to contact the teeth and lip of the user so as to indicate to the user that the inhaler has been inserted into the oral cavity of the user in a correct position.

9. An inhaler according to claim 1 wherein an opening of the mouthpiece to be inserted into the mouth of a user has a major axis and a minor axis, and wherein the horizontal aspect ratio of these axes is between 2:1 and 4:1.

10. An inhaler according to claim 9 wherein said horizontal aspect ratio of the axes is substantially 3:1.

11. An inhaler according to claim 3 wherein said air-flow-controlling check valve mechanism includes an air passage bore of extended length for straightening air-flow, a bulb reciprocable in said bore, and biasing means urging said bulb out of an air-flow inhibiting position.

12. An inhaler according to claim 11 wherein said check valve mechanism includes a rod upon which said bulb can reciprocably travel; and a rod head having vanes mounted thereon, said vanes engaging a venturi passage.

13. An inhaler according to claim 11 wherein said biasing means comprises a spring positioned and connected to said bulb with a tensile force to urge said bulb out of an air-flow in inhibiting position.

14. An inhaler according to claim 11 wherein said spring has a spring rate selected so as to let said bulb to be drawn away from its air-flow-inhibiting position only when the air-flow across and past said bulb creates a force sufficient to provide an air-flow of a volume and rate sufficient to cause said air-flow to take up medicament in the cartridge, de-agglomerate the fluidized medicament and deliver the medicament to the user's upper respiratory tract in a dispersed form.

15. An inhaler according to claim 11 further including a rod mounted in said air flow passage, and vanes mounted on said rod to straighten air-flow passing said vanes, and to center and align the rod within the inhaler housing receiving bore.

16. An inhaler according to claim 3 further including a check valve subhousing removably mountable in said inhaler housing, the subhousing mounting said bulb and said biasing means.

17. A medicament-dispensing inhaler comprising, in combination, a mouthpiece adapted to deliver airborne medicament to a patient's upper respiratory tract at a position away from the patient's mouth front and upper oropharyngeal region, and a housing, the housing having a mixing cavity adapted to encourage a flow of air to mix with, deagglomerate and transport medicament to and through the mouthpiece.

18. An inhaler according to claim 17 further including a cartridge adapted to contain a medicament; adapted to be mounted within the housing mixing cavity; and adapted to be altered in configuration between an open medicament-dispensing configuration and a closed medicament-retaining configuration.

19. An inhaler according to claim 17 further including an air-flow controlling check valve mechanism adapted to be mounted within the inhaler for assisting in the delivery of an air flow of predetermined velocity and volume into and through the mixing cavity.

20. An inhaler according to claim 17 wherein the inhaler includes a venturi for the regulation of proper volumetric aerosolizing air-flow through the cartridge and bypass-air-flow around the cartridge.

21. A medicament-dispensing inhaler comprising, in combination, a mouthpiece adapted to deliver airborne medicament to a patient's upper respiratory tract; a housing, the housing having a mixing cavity adapted to encourage a flow of air to mix with, deagglomerate and transport medicament to and through the mouthpiece; and a check value mechanism adapted to assist that flow of air to the mixing chamber only when there is sufficient inhalation by the patient to deliver a full dose of medicament to the patient.

22. An inhaler according to claim 21 wherein said air-flow controlling check valve mechanism is adapted to be mounted within the housing for assisting in the delivery of an air flow of predetermined velocity and volume into and through the mixing cavity and mouthpiece.

23. An inhaler according to claim 21 wherein said air-flow controlling check valve includes a sub-housing which permits the check valve to be removed as a unit from the inhaler housing.

24. A medicament-dispensing inhaler, comprising, in combination, a mouthpiece adapted to deliver airborne medicament to a patient's upper respiratory tract at a position away from the patient's mouth front and upper oropharyngeal region, and a housing, the housing having a mixing cavity including a cartridge mounting mechanism to selectively mount a medicament-containing cartridge; and an air-flow cavity for assisting in the delivery of air into and through a cartridge in the mixing cavity and into and through the mouthpiece, the cartridge mounting mechanism including mechanism for preventing the patient who is using the inhaler from receiving a partial dose of medicament.

25. A medicament-dispensing inhaler, comprising, in combination, a mouthpiece adapted to deliver airborne medicament to a patient's upper respiratory tract at a position away from the patient's mouth front and upper oropharyngeal region, and a housing, the housing having a mixing cavity including a cartridge-mounting mechanism to selectively mount a medicament-containing cartridge; the cartridge-mounting mechanism having keying structure adapted to mate uniquely with cartridge keying structures so as to permit only preselected cartridge to be mounted in and used with the inhaler.

26. An inhaler according to claim 25 wherein said cartridge-mounting mechanism includes a cap movable between an open position for mounting and de-mounting the cartridge, and a closed position permitting the inhaler to be used.

27. An inhaler according to claim 25 further including an interlock mechanism for prohibiting said inhaler mouthpiece from being used unless said cap is in its closed position.

28. A medicament-dispensing inhaler comprising, in combination, a mouthpiece having an air flow passage and being adapted to deliver airborne medicament to a patient's upper respiratory tract at a position away from the patient's mouth front and upper oropharyngeal region, and a housing, the housing having a mixing cavity including a cartridge mounting mechanism and an airflow cavity for assisting in the delivery of air into and through a cartridge in the mixing cavity and past that cartridge in the mixing cavity and into and through the mouthpiece airflow passage, the mouthpiece airflow passage being located to communicate with the mixing cavity at a point tangential to the interior of the mixing cavity so as to encourage a swirling air flow within the mixing cavity; and a de-agglomerating high-shear air flow entering the mouthpiece tube.

29. A medicament-dispensing inhaler, comprising, in combination, a mouthpiece having an air flow passage and being adapted to deliver airborne medicament to a patient's upper respiratory tract at a position away from the patient's mouth front and upper oropharyngeal region; a mixing cavity including an airflow cavity for assisting in the delivery of air into and through mouthpiece, for fluidizing a powder in the mixing chamber, and for delivering airflow and airborne medicament to the mouthpiece; and a flow control check valve for controlling a flow of air into the mixing cavity and mouthpiece, the check valve being adapted to inhibit the loss of medicament when air is blown back into the mouthpiece and mixing cavity.
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