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Claims for Patent: 8,146,588

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Claims for Patent: 8,146,588

Title:Unit dose capsules and dry powder inhaler
Abstract: Described are dry powder inhalers composing an intake section, a mixing section and a mouthpiece. The mixing section can accommodate a capsule having a top keying portion and containing a dry powder medicament. The top keying portion of the capsules may fit within complementary keying structures in inhaler mixing sections.
Inventor(s): Steiner; Solomon S. (Mount Kisco, NY), Feldstein; Robert (Yonkers, NY), Fog; Per B. (Bedford Hills, NY), Poole; Trent A. (South Amherst, MA)
Assignee: MannKind Corporation (Valencia, CA)
Application Number:11/949,707
Patent Claims: 1. A dry powder inhaler comprising: an intake section; a mixing section; and a mouthpiece portion; wherein the intake section and mouthpiece portion each have a longitudinal axis, and air flows through a passage extending from the intake section through the mixing section through the mouthpiece portion, and wherein the mouthpiece portion is structurally configured to engage with the intake section and the mouthpiece portion is movable relative to the intake section, and wherein the inhaler further comprises a joint engaging the mouthpiece portion to the intake section, wherein the mixing section is a chamber which comprises a holder for a capsule having a top keying portion, and the holder is nested inside the chamber, wherein the holder grips the bottom portion of the capsule, and the holder opens the capsule when an angle defined by the longitudinal axis of the intake section and the longitudinal axis of the mouthpiece portion and the joint vertex is a first fixed number of degrees and closes the capsule when the angle defined by the longitudinal axis of the intake section and the longitudinal axis of the mouthpiece and the joint vertex is a second fixed number of degrees.

2. The dry powder inhaler of claim 1, wherein the mixing section comprises a mixing chamber configured to receive a medicament capsule.

3. The dry powder inhaler of claim 1 further comprising a cover operably configured on the inhaler over the mixing section.

4. The dry powder inhaler of claim 3 wherein the cover only opens when the mouthpiece portion attains a predetermined position relative to the intake section to load or unload a medicament capsule.

5. The dry powder inhaler of claim 4, wherein the predetermined position is between approximately ninety degrees and one hundred and eighty degrees.

6. The dry powder inhaler of claim 1, wherein the mixing section comprises a capsule holder and a swivel joint.

7. The dry powder inhaler of claim 1, further comprising a mouthpiece storage section within the dry powder inhaler, wherein the storage section houses the mouthpiece portion in a closed position.

8. The dry powder inhaler of claim 1 wherein the intake section comprises an inner channel, said intake section further comprising: an intake port; a flow regulator; and a bleed orifice; wherein the intake port and the bleed orifice both admit air to the dry powder inhaler, the rate of admission of said air being controlled by both the flow regulator and the bleed orifice and wherein the flow regulator comprises: i) a piston comprising a piston head connected to a piston rod; and ii) one or more springs connected to the piston and the inner walls of an intake chamber, wherein the piston rod is wider at its proximal portion connected to the piston head and narrower at its distal portion, the piston head covers the intake port, the piston head moves away from the intake port to admit air to the intake port, and wherein movement of the piston head is modulated by the springs connecting the piston to the inner walls of the intake chamber.

9. The dry powder inhaler of claim 8 wherein the intake chamber further comprises a feedback module mechanically connected to the intake chamber and the feedback module generates a signal in response to the flow of air in the intake chamber.

10. The dry powder inhaler of claim 9, wherein the feedback module comprises signal generators selected from the group consisting of electronic apparatuses to generate audio signals and mechanical devices to generate audio signals.

11. The dry powder inhaler of claim 9 wherein the signal from the feedback module is varied by a user of the dry powder inhaler.

12. The dry powder inhaler of claim 1, wherein the first fixed number of degrees needed to open the capsule is between approximately ninety degrees and one hundred and eighty degrees, and the second fixed number of degrees to dose the capsule is between approximately ninety and zero degrees relative to the intake section longitudinal axis.

13. The dry powder inhaler of claim 1, wherein the mixing section is a chamber which comprises a holder adapted and configured to receive and hold a capsule having at least one keying portion.

14. The dry powder inhaler of claim 1 wherein the mixing chamber comprises a Venturi chamber that is shaped to give air passing through it a cyclonic flow.

15. The dry powder inhaler of claim 1, wherein the mouthpiece portion is sized to extend into the oral cavity of a user.

16. The dry powder inhaler of claim 15 wherein the mouthpiece portion further includes a tongue depressor.

17. The dry powder inhaler of claim 1 wherein the mouthpiece portion has an outer surface comprising a protrusion on the outer surface to contact the lips of the user and to indicate to the user that the dry powder inhaler is inserted into the oral cavity of the user in the correct position.

18. The dry powder inhaler of claim 1 wherein the mouthpiece portion has an inner channel shaped to enable a reduction in air velocity.

19. The dry powder inhaler of claim 1 wherein the mouthpiece has an air passage and an opening having a major axis and a minor axis, said opening having a horizontal aspect ratio between 2:1 and 4:1.

20. The dry powder inhaler of claim 1 wherein the inhaler comprises a pneumatic resistance circuit.

21. The dry powder inhaler of claim 1, wherein each of the intake section, mixing section and mouthpiece portion comprise an inner channel and wherein the inner channel of the intake section is isolated from outside air while the inner channel of the mixing section and the inner channel of the mouthpiece portion are exposed to outside air when the mouthpiece portion is in a capsule loading and unloading position.

22. The dry powder inhaler of claim 1, wherein the mixing section has a long axis, and wherein the air flowing through the mixing section to the mouthpiece portion exits the mixing section at a tangent to a circle described by a radius about the axis of the mixing section.

23. The dry powder inhaler of claim 1, wherein the mixing section and the mouthpiece portion move about the intake section between a storage position, a capsule loading and unloading position and an extended position.

24. The dry powder inhaler of claim 23 wherein said extended position is at a configuration wherein the mouthpiece and intake section are separated by approximately one hundred and eighty degrees.

25. A dry powder inhalation system, comprising: a dry powder inhaler; and a capsule containing a medicament; wherein the dry powder inhaler comprises an intake section; a mixing section, and a mouthpiece portion; the intake section, the mixing section and the mouthpiece portion have an air flow passage extending from the intake section through the mixing section and the mouthpiece portion, and the mixing section comprises a cover, a mixing chamber and a capsule holder; wherein the capsule comprises a top half having at least one aperture and a bottom half having one or more additional apertures; and the bottom half is fitted into the top half and each of the top or bottom half has a key configured to engage with the dry powder inhaler; and wherein the mouthpiece portion is configured to engage and rotate about a swivel joint relative to the intake section.

26. The dry powder inhaler system of claim 25, wherein the capsule holder is configured to grip and turn the top half of the capsule about the bottom half of the capsule from a closed position to an open position of the capsule or from an open to a dosed position of the capsule when the mouthpiece portion is rotated.

27. The dry powder inhaler system of claim 26, wherein the apertures of the top half of the capsule align with at least one additional aperture of the bottom half of the capsule in the open position.

28. The dry powder inhaler system of claim 25, wherein the intake section comprises an intake chamber having an inner channel, one or more intake ports, a piston, at least one spring, and an exit port.
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