IPC분류정보
국가/구분 |
United States(US) Patent
등록
|
국제특허분류(IPC7판) |
|
출원번호 |
US-0735532
(2013-01-07)
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등록번호 |
US-8671938
(2014-03-18)
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발명자
/ 주소 |
- Striebig, Rachel
- Allen, Matthew
- Ruckdeschel, Thomas W.
- Buckner, III, Charles A.
- Harris, David
- Lewis, Scott Alexander
- Gow, Andrew Murray
- Tuckwell, Jonathan David
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출원인 / 주소 |
|
대리인 / 주소 |
Myers Bigel Sibley & Sajovec, P.A.
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인용정보 |
피인용 횟수 :
0 인용 특허 :
58 |
초록
Dry powder inhalers include radially-extending discrete, typically dose-specific, airway channels serially forming a portion of the inhalation pathway to deliver dry powder to a user using the inhalers.
대표청구항
▼
1. A dry powder dose container assembly, comprising: a dose container disk having opposing upper and lower planar primary surfaces and a plurality of circumferentially spaced apart downwardly extending channels defining dose containers with pierceable sealant residing on the upper and lower primary
1. A dry powder dose container assembly, comprising: a dose container disk having opposing upper and lower planar primary surfaces and a plurality of circumferentially spaced apart downwardly extending channels defining dose containers with pierceable sealant residing on the upper and lower primary surfaces covering respective dose containers; andat least one airway disk residing above or below the dose container disk, the at least one airway disk comprising a plurality of circumferentially spaced apart, radially extending airway channels and a rigid ceiling or floor with circumferentially spaced apart apertures extending therethrough, at least one over or under respective dose containers with the sealant of the dose container disk residing between the at least one airway disk and the dose container disk. 2. A dry powder dose container assembly according to claim 1, wherein the at least one airway disk includes a first airway disk and a second airway disk, the first airway disk residing below the dose container disk and the second airway disk residing above the first airway disk with the dose container disk therebetween, wherein at least one of the airway channels of the first airway disk is aligned with a corresponding at least one of the airway channels of the second airway disk with at least one dose container therebetween to define cooperating airway channels, and wherein the dose container assembly further comprises dry powder in the dose containers. 3. A dry powder dose container according to claim 2, wherein the first airway disk abuts the lower primary surface of the dose container disk and/or the sealant on the lower primary surface of the dose container disk and the second airway disk abuts the upper primary surface of the dose container disk and/or the sealant on the upper primary surface of the dose container disk. 4. A dry powder dose container assembly according to claim 1, wherein the airway channels of the at least one airway disk are elongate across the airway disk, wherein the elongate channels have opposing first and second end portions, with the first end portion being substantially open and the second end portion being substantially closed, and wherein the first end portion resides at an inner or outer perimeter of the disk and the second end portion resides above or below a respective dose container. 5. A dry powder dose container according to claim 2, wherein the cooperating channels are cooperating pairs of airway channels, one upper and one lower channel with the at least one dose container therebetween, the upper and lower channel and the corresponding dose container defining a single-use or dual-use airway path in an inhaler for delivering dry powder from the at least one dose container held therebetween. 6. A dry powder dose container assembly according to claim 1, wherein the at least one airway disk is snugly attached to the dose container disk with a substantially air-tight interface therebetween, and wherein the at least one airway disk or the dose container disk includes gear teeth on an inner or outer perimeter thereof that cooperate with an indexing mechanism in an inhaler to rotate the dose container assembly to position respective dose containers at a dispensing position in the inhaler so that, in a dispensing position, at least one of the airway channels is in fluid communication with (a) a dose container held therebetween and (b) a mouthpiece for allowing a user to inhale dry powder released from the dose container using the at least one airway channel as an exit flow path to the mouthpiece. 7. A dry powder dose container assembly according to claim 2, wherein the first airway disk airway channels have a floor with a closed surface and a pair of upwardly extending sidewalls, and wherein the second airway disk has the ceiling with the circumferentially spaced apart apertures, wherein the second airway disk channels each include a pair of downwardly extending sidewalls that face the sidewalls of the first airway disk channels. 8. A dry powder dose container assembly according to claim 1, wherein the dose container disk includes a first row of circumferentially spaced apart apertures at a first radius and a second row of circumferentially spaced apart apertures at a second radius positioned so that the first and second rows are concentric with respect to a center of the disk. 9. A dry powder dose container assembly according to claim 8, wherein the first row of dose container apertures have radially extending centerlines that are offset circumferentially from radially extending centerlines of the second row of dose container apertures. 10. A dry powder dose container assembly according to claim 1, wherein the dose container disk has 30 dose containers with a corresponding 30 dose disk apertures in the first row and 30 dose containers with a corresponding 30 dose disk apertures in the second row, and wherein the at least one airway disk has 60 airway channels configured with alternating channels of first and second different radial lengths, the first length corresponding to channels extending from an inner or outer perimeter of the airway disk to dose containers in the first row and the second length corresponding to channels extending from an inner or outer perimeter of the airway disk to dose container apertures in the second row. 11. A dry powder dose container assembly according to claim 1, wherein the dose container disk has first and second radially spaced apart rows of dose container apertures, one for each of the dose containers, wherein the at least one airway disk includes a plurality of short airway channels and a plurality of long airway channels, the short airway channels associated with the first row of dose container apertures and the long airway channels associated with the second row of dose container apertures, and wherein the short and long airway channels reside adjacent each other and alternate circumferentially about the dose disk assembly such that one short channel resides between two long channels. 12. A dry powder dose container assembly according to claim 2, wherein the cooperating channels are cooperating pairs of channels, with at least one of the airway channels in each cooperating pair of channels including a curvilinear airflow path portion that rises a first distance above a respective dose container, then turns toward an inner or outer perimeter of the dose container disk for a second distance, then travels down away from the dose container disk for a third distance, wherein the third distance is at least the same as the first distance, whereby the curvilinear airflow path portion inhibits undesired spillage of the dry powder from the inhaler. 13. A dry powder dose container assembly according to claim 1, wherein the at least one airway disk airway channels each have an open end that all reside on one of an inner or outer perimeter of the at least one airway disk. 14. A dry powder dose container assembly according to claim 2, wherein the dose container disk and the first and second airway disks have a substantially circular inner perimeter and the dose container disk and the first and second airway disks have substantially the same outer diameters, wherein the dose container disk includes a recess on the inner perimeter thereof, wherein at least one of the first and second airway disks includes circumferentially spaced apart upwardly or downwardly extending tabs on the inner perimeter thereof, wherein one of the tabs includes a radially extending portion that engages the recess of the dose container disk to orient the dose container disk with respect to the first and second airway disks, and wherein the tabs of at least one of the airway disks include crush ribs that engage when the first and second airway disks are assembled together, and wherein the first and second airway disks are press-fit together to engage the crush ribs with the dose container disk sandwiched tightly therebetween to form an integral securely attached assembly. 15. A dry powder dose container assembly according to claim 1, further comprising bleed holes in an inner or outer perimeter wall of the at least one airway disk, a respective bleed hole in communication with an air inlet path that merges into a respective airway channel of the at least one airway disk. 16. A dry powder dose container assembly according to claim 2, wherein the cooperating channels are cooperating pairs of airway channels that are in fluid communication during dispensing of a dose of dry powder in the at least one dose container held therebetween, and wherein the cooperating pairs of airway channels together with an opened dose container define a generally U shape airflow path with long sides of the U corresponding to each airway channel and being oriented to extend in a radial direction across the first and second airway disks. 17. A dry powder dose container assembly according to claim 1, wherein each airway channel defines a discrete corresponding dry powder exit port, and wherein the respective discrete dry powder exit ports are circumferentially spaced apart and reside on an outer or inner perimeter of the at least one airway disk. 18. A dry powder dose container assembly according to claim 1, wherein the at least one airway disk is attached to the dose container disk to be able to rotate therewith, and wherein the airway channels are positioned relative to the dose container disk so that at least one airway channel is aligned with at least one dose container. 19. A dry powder dose container assembly in combination with an inhaler according to claim 1, wherein the inhaler comprises an inhaler body with an inhalation port and a piercing mechanism, wherein, in operation, the piercing mechanism is configured to enter the airway ceiling or floor aperture, pierce the sealant over and under respective dose containers, and remain in or retract from the dose container during inhalation. 20. The combination of claim 19, wherein the dose container assembly is configured to radially translate in a predefined direction to sealably engage an interface or wall associated with an exit airflow path in the inhaler. 21. The combination of claim 19, wherein the inhaler comprises at least one seal residing between an outer or inner perimeter of the at least one airway disk and a wall associated with an exit airflow path in the inhaler. 22. The combination of claim 19, wherein the inhaler comprises a lever in communication with a biasing post that resides in the inhaler proximate an outer perimeter or inner perimeter of the dose container assembly, wherein in response to movement of the lever, the biasing post pushes the dose container assembly radially against either a mouthpiece or an exit airflow path member in fluid communication with the mouthpiece. 23. The combination of claim 19, wherein the inhaler has two airway disks, an upper airway disk and a lower airway disk sandwiching the dose container disk therebetween, wherein the inhaler has an indexing mechanism in communication with the dose container assembly, and wherein the piercing mechanism and indexing mechanism are configured to index/pierce/deliver or pierce/deliver/index to isolate, from an inhalation path, an upper or lower airway channel associated with the at least one airway disk in communication with a corresponding opened dose container. 24. The combination of claim 19, wherein the dose container disk includes a first row of circumferentially spaced apart apertures at a first radius and a second row of circumferentially spaced apart apertures at a second radius so that the first and second rows are concentric with respect to a center of the disk, and wherein the piercing mechanism includes first and second piercers, the first piercer configured to pierce the sealant over and under the respective dose container apertures in the first row, and the second piercer configured to pierce the sealant over and under the respective dose container apertures in the second row. 25. The combination of claim 19, wherein the piercer mechanism comprises a corkscrew piercer configured to pierce the sealants with a straight vertical non-rotational movement. 26. The combination of claim 19, wherein the piercer mechanism is configured to serially alternate between rows to pierce the sealants over and under a dose container in a first row of dose container apertures, then pierce the sealants over and under a dose container in a second row of dose container apertures. 27. The combination of claim 19, wherein the piercing mechanism comprises a fluted piercer configured to pierce the sealants. 28. The combination of claim 27, wherein the fluted piercer comprises three or four lobes, and wherein one of the at least one airway disks has circumferentially spaced apart apertures, one aperture residing over or under a respective dose container, the airway disk apertures having a perimeter shape corresponding to the three or four lobes, respectively, of the fluted piercer. 29. The combination of claim 19, wherein the piercing mechanism comprises a solid piercer. 30. The combination of claim 19, wherein the dose container comprises a dry powder having a pharmaceutically active agent, and wherein the agent comprises one or more of the following bronchodilators: albuterol, salmeterol, ephedrine, adrenaline, fenoterol, formoterol, isoprenaline, metaproterenol, phenylephrine, phenylpropanolamine, pirbuterol, reproterol, rimiterol, terbutaline, isoetharine, tulobuterol, or (−)-4-amino-3,5-dichloro-α-[[6-[2-(2-pyridinyl)ethoxy]hexyl]methyl]benzenemethanol;wherein the bronchodilator may be used in the form of salts, esters or solvates to thereby optimize the activity and/or stability of the medicament. 31. A dry powder inhaler, comprising: an inhaler body with an inhalation port;a dose container assembly held in the inhaler body, the dose container assembly comprising a dose container disk having a plurality of circumferentially spaced apart apertures, and an airway disk having a plurality of airway channels with upwardly or downwardly extending sidewalls residing under or over the dose container disk, each of the airway channels being in communication with at least one dose container aperture, whereby the airway disk airway channels define a plurality of spaced apart inhalation delivery paths that individually communicate with the inhalation port;a dose container opening mechanism in the inhaler body configured to open a dose container held by the dose container disk in a dispensing position in the inhaler; andan indexing mechanism in the inhaler body configured to rotate the dose container assembly to place a dose container held by the dose container disk in the dispensing position. 32. An inhaler according to claim 31, wherein the airway disk includes circumferentially spaced apart apertures, one residing over or under a respective dose container aperture, wherein the dose container assembly further comprises a first sealant that resides over the upper surface of the dose container disk and a second sealant that resides over the lower surface of the dose container disk to close the dose container apertures with dry powder held therein and define dose containers, and wherein the dose container opening mechanism comprises a piercer that is configured to pierce the first and second sealant layers. 33. An inhaler according to claim 31, wherein airway disk is a lower airway disk, wherein the dose container assembly further comprises: an upper airway disk having a plurality of airway channels with downwardly extending sidewalls residing above the dose container disk, wherein the upper and lower airway disks hold the dose container disk therebetween, wherein the upper and lower airway disk channels are aligned to define a plurality of cooperating pair of airway channels, each cooperating pair of airway channels associated with a dose container aperture, and wherein each cooperating pair of channels are configured to serially communicate with the inhalation port, wherein the upper airway disk includes an upper surface that has a plurality of circumferentially spaced apart apertures, one residing over a corresponding dose disk aperture. 34. An inhaler according to claim 31, wherein the dose container apertures are arranged in a staggered concentric configuration of inner and outer rows. 35. An inhaler according to claim 32, wherein the dose container opening mechanism is configured to pierce the first and second sealants associated with a dose container and occlude or seal a respective airway and/or airway disk aperture during inhalation. 36. An inhaler according to claim 33, wherein the dose container opening mechanism comprises a member that is configured to substantially seal the upper airway disk aperture during an inhalation. 37. A dry powder inhaler, comprising: an inhaler body with an inhalation port;a dose container assembly held in the inhaler body, the dose container assembly comprising: a dose container disk having a planar body with opposing upper and lower primary surfaces and a plurality of circumferentially spaced apart open channels extending therethrough sealed shut with first and second sealant layers attached to upper and lower primary surfaces of the dose container disk to define a respective floor and ceiling of the dose container channels to form sealed dose containers, wherein the sealed dose containers hold dry powder therein;an upper airway disk residing over the dose container disk, the upper airway disk comprising a plurality of circumferentially spaced apart, radially extending airway channels with downwardly extending sidewalls and a ceiling with a plurality of circumferentially spaced apart apertures extending therethrough, a respective aperture residing over a respective dose container; anda lower airway disk residing under the dose container disk, the lower airway disk comprising a plurality of circumferentially spaced apart, radially extending airway channels with upwardly extending sidewalls, wherein pairs of the lower airway disk channels and the upper airway disk channels are aligned with at least one corresponding dose container therebetween;a piercing mechanism configured to enter a respective airway disk ceiling aperture and extend down to pierce the floor and ceiling sealant layers to open a dose container in a dispensing position in the inhaler; andan indexing mechanism in communication with the dose container disk configured to rotate the dose container assembly to place dose containers into the dispensing position. 38. A dry powder inhaler, comprising: a circular dose container disk assembly having a plurality of circumferentially spaced apart radially oriented airway channels aligned with a plurality of circumferentially spaced apart sealed dose containers with dry powder therein held in first and second concentric rows of different radius, wherein the disk assembly includes a center dose disk having upper and lower surfaces with a sealant material, and wherein prior to active dispensing, the airway channels are drug free, and wherein one end of the airway channels define exit flow paths that are serially in communication with a mouthpiece;a mouthpiece configured to engage an outer and/or inner perimeter of the dose container disk to serially communicate with the circumferentially spaced apart airway channels to entrain dry powder from an opened dose container to deliver dry powder to a user;a piercing mechanism configured to extend up and down to pierce the sealant on both the upper and lower surfaces of the center disk residing over a respective dose container to open the dose containers to release the dry powder therein into an overlying or underlying airway channel; andan indexing mechanism in communication with the circular dose disk assembly. 39. A dry powder dose container assembly, comprising: a first dose container disk having opposing upper and lower primary surfaces and a plurality of circumferentially spaced apart dose containers;a second dose container disk stacked on the first dose container disk having opposing upper and lower primary surfaces and a plurality of circumferentially spaced apart dose containers; andat least one airway disk residing above or below the first or second dose container disk, the at least one airway disk comprising a plurality of circumferentially spaced apart radially extending airway channels.
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