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Claims for Patent: 7,464,706

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Claims for Patent: 7,464,706

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:10/655,153
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, further including a cartridge comprising a first element defining an air inlet hole and an air outlet hole, and a second element, the 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.

2. 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.

3. 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.

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

5. 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.

6. 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.

7. An inhaler according to claim 6 wherein said horizontal aspect ratio of the axes is substantially 3:1.

8. 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, and a cartridge mounted within the mixing cavity, the cartridge comprising a first element defining and air inlet hole and an air outlet hole, a second element snugly fitted to the first element so as to define, with the first element, a medicament-containing cavity, the second element further defining and air inlet hole and 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 to thereby place the element inlet and outlet holes out of registry with one another and thereby prohibit air flow through the cartridge and securely retain medicament within the cartridge.

9. An inhaler according to claim 8 wherein said first and second cartridge elements have a substantially circular cross-sectional aspect and wherein said first and second elements are fitted together with an at least partially overlapping telescopic fit so as to permit said first and second elements to be angularly twisted, relative to one another, between said configurations.

10. An inhaler according to claim 8 wherein at least some of said cartridge element inlet holes and outlet holes are defined by a beveled cross-sectional shape.

11. An inhaler according to claim 8 wherein said cartridge first element and second element are interlocked by ring and groove seals.

12. 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 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, and a cartridge mounted within the mixing cavity, the cartridge comprising a hollow first element defining an air inlet hole and an air outlet hole, a hollow second element snugly fitted to the first element so as to define, with the first element, a medicament-containing cavity, the second element further defining an air inlet hole and an air outlet hole, the first element and the second element being twistable 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 to thereby place the element inlet and outlet holes out of registry with one another and thereby prohibit air flow through the cartridge and securely retain medicament within the cartridge, the inhaler further comprising a swivel mechanism for twisting the mouthpiece between a storage position, a cartridge insertion and removal position, and a use position; and for simultaneously twisting the cartridge first and second elements between an air-flow-permitting configuration and a medicament-retaining configuration.

13. An inhaler according to claim 1 wherein said cartridge elements are made of a transparent plastic having neutral electrostatic characteristics.

14. 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, further including an air-flow controlling check 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 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.

15. An inhaler according to claim 14 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.

16. An inhaler according to claim 14 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.

17. An inhaler according to claim 14 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.

18. An inhaler according to claim 14 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.

19. An inhaler according to claim 14 further including a check valve subhousing removably mountable in said inhaler housing, the subhousing mounting said bulb and said biasing means.

20. An inhaler according to claim 1 wherein said first and second cartridge elements have a substantially circular cross-sectional aspect and wherein said first and second elements are fitted together with an at least partially overlapping telescopic fit so as to permit said first and second elements to be angularly twisted, relative to one another, between said configurations.

21. An inhaler according to claim 1 wherein said at least some of said cartridge element inlet holes and outlet holes are defined by a beveled cross-sectional shape.

22. An inhaler according to claim 1 wherein said cartridge first element and second element are interlocked by ring and groove seals.

23. An inhaler according to claim 1 wherein said cartridge elements are made of a transparent plastic having neutral electrostatic characteristics.

24. An air-flow controlling check valve mechanism adapted to be mounted within a housing air-flow cavity of an inhaler for assisting in the delivery of an air-flow of predetermined velocity and volume into and through an inhaler cartridge and mouthpiece wherein said check valve mechanism includes an air passage bore of extended length for straightening air-flow, a bulb reciprocable in said bore, and a venturi communicating with said bore.

25. An air-flow controlling check valve mechanism according to claim 24 further including a rod mounted in said bore, said bulb being mounted on said rod for reciprocable motion.

26. An air-flow controlling check valve mechanism according to claim 24 wherein said biasing means comprises a spring positioned and connected to said bulb with a tensile force to draw said bulb away from said venturi.

27. An air-flow controlling check valve mechanism according to claim 26 wherein said spring has a spring rate selected so as to permit said bulb to be drawn away toward said venturi only when the air-flow across and past said bulb creates a force to provide an air-flow of a volume and rate 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.

28. An air-flow controlling check valve mechanism according to claim 24 further including chutes mounted on the perimeter of said bulb to straighten air-flow passing over and around said bulb.

29. An air-flow controlling check valve mechanism according to claim 24 further including a check valve subhousing removably mountable in said bore, the subhousing mounting said bulb, and said biasing means.

30. A method of using an inhaler to deliver a pre-determined amount of medicament to an inhaler user, comprising the steps of installing a cartridge containing the predetermined amount of medicament in the inhaler, configuring the cartridge for medicament delivery by configuring the inhaler for use, and drawing a predetermined volume of air at a predetermined rate through the inhaler so as to aerosolize substantially all the medicament in the cartridge and deliver the aerosolized medicament to the user wherein said cartridge comprises at least two cartridge elements, and wherein the step of configuring the cartridge for medicament delivery comprises the step of twisting the cartridge elements relative to one another.

31. A method of using an inhaler according to claim 30 wherein the step of drawing a predetermined volume of air at a predetermined rate comprises the step of drawing air past a flow-control check valve.

32. 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 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.

33. An inhaler according to claim 32 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.

34. An inhaler according to claim 32 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.

35. 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 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.

36. An inhaler according to claim 35 further including an interlock mechanism for prohibiting said inhaler mouthpiece from being used unless said cap is in its closed position.
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