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Claims for Patent: 6,543,448

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Claims for Patent: 6,543,448

Title: Apparatus and methods for dispersing dry powder medicaments
Abstract:A method for aerosolizing a powdered medicament comprises coupling a powder inlet end of a feed tube with a penetration in a receptacle containing the powder. Powder is drawn upward through the tube and dispersed in a high pressure gas stream flowing past a portion of the feed tube. Apparatus comprise the feed tube mounted within a base enclosure proximate a holder for one or more receptacles, which may be in the form of a cartridge containing a plurality of receptacles formed in a continuous web. The cartridge may be reciprocated relative to the feed tube and a separate piercing mechanism in order to sequentially piercing the receptacle and thereafter couple the feed tube through the resulting penetration for extracting the powder. Alternatively, penetration(s) through the receptacle may be formed as the feed tube is coupled, or some penetrations formed prior to coupling with other penetrations formed at the time of coupling.
Inventor(s): Smith; Adrian E. (Belmont, CA), Burr; John D. (Redwood City, CA), Etter; Jeffrey W. (Castro Valley, CA), Axford; George S. (Menlo Park, CA), Anthony; Jack M. (Palo Alto, CA)
Assignee: Inhale Therapeutic Systems, Inc. (San Carlos, CA)
Application Number:09/583,300
Patent Claims: 1. An improved apparatus for aerosolizing a powdered medicament, the apparatus being of the type having a housing and a source of pressurized gas for aerosolizing the powder, wherein the improvement comprises: a pressurization cylinder; a piston slidable within the cylinder; a release valve in communication with the cylinder; and a handle assembly having a handle operably attached to the piston and a means for closing the valve, wherein translation of the handle closes the valve and axially translates the piston within the cylinder to produce the pressurized gas.

2. An improved apparatus as in claim 1, wherein the release valve comprises a valve stem connected to a valve poppet, wherein the means for closing the valve comprises a roller cam adjacent the valve stem for translating the valve stem to close the valve as the handle is translated radially outward from the housing.

3. An improved apparatus as in claim 2, wherein the handle assembly further comprises a toggle link which moves over-center to hold the roller cam against the valve stem and keep the valve closed.

4. An improved apparatus as in claim 3, further comprising a release button for translating the roller cam from the over-center position to open the valve.

5. An improved apparatus as in claim 3, wherein the handle assembly further includes a linkage between the handle and the piston, wherein the linkage reciprocally translates the piston between a retracted position and a charged position within the cylinder as the handle is translated radially outward and radially inward relative to the housing.

6. An improved apparatus as in claim 4, further comprising an interlocking means for preventing inward radial translation of the handle until the toggle link has moved over-center.

7. An improved apparatus as in claim 5, wherein the interlocking means comprises a ratchet and a pawl.

8. An improved apparatus as in claim 4, wherein the cylinder includes a one-way valve for allowing air to enter the cylinder as the piston is translated to the retracted position.

9. An improved apparatus as in claim 1, wherein the powdered medicament is held within a receptacle, and further comprising a feed tube having an inlet end, an outlet end, and a lumen extending therebetween, wherein the inlet end may be inserted into the receptacle so that compressed gas exiting the release valve may be flowed past the outlet end, wherein powder from the receptacle is extracted through the tube and dispersed in the flowing compressed gas to form the aerosol.

10. An improved apparatus as in claim 9, further comprising means for piercing at least one hole in an access surface of the receptacle simultaneously with inserting the inlet end of the feed tube into the receptacle.

11. An improved apparatus as in claim 10, wherein the piercing means comprises a pair of pointed tabs, and wherein the tabs are each disposed at an oblique angle relative to the access surface of the receptacle when the tabs are pierced through the access surface.

12. An improved apparatus as in claim 11, further comprising means for reciprocally translating the receptacle toward and away from the piercing means.

13. An improved apparatus as in claim 12, wherein the translating means comprises an over-center linkage for locking the receptacle in place upon insertion of the inlet end of the feed tube into the receptacle.

14. An improved apparatus as in claim 13, further comprising a positioning pin for aligning the receptacle in a preferred orientation relative to the piercing means while inserting the inlet end of the feed tube into the receptacle.

15. An improved apparatus as in claim 1, wherein the handle assembly includes four linkages for attaching the handle to the housing, wherein the handle may be translated radially outward and radially inward relative to the housing with a generally constant force.

16. An improved apparatus as in claim 1, further comprising means on the housing for producing verbal operating instructions.

17. An apparatus for aerosolizing a powder held in a receptacle having a puncturable access surface, the apparatus comprising: a housing; a source of pressurized gas; a capture chamber attached to the housing; and a transjector assembly held within the housing, said transjector assembly having a means for piercing the access surface of the receptacle and for receiving pressurized gas to draw powder from the receptacle and into the capture chamber.

18. An apparatus as in claim 17, wherein the transjector assembly receives gas directly from the gas source and delivers powder directly to the capture chamber without powder passing through other portions of the apparatus.

19. An apparatus as in claim 17, further comprising an interface seal between the transjector assembly and the housing, whereby pressurized gas may be passed from the housing to the transjector assembly without substantial loss of the gas.

20. An apparatus as in claim 19, wherein the interface seal is angled relative to a central axis of the transjector assembly.

21. An apparatus as in claim 17, further comprising a receptacle seal for forming a seal between the transjector and the receptacle.

22. An apparatus as in claim 17, wherein the transjector assembly is keyed to be repeatedly received into the housing in a unique orientation.

23. An apparatus as in claim 17, wherein the capture chamber is axially slidable over the housing, whereby the capture chamber may be placed in a collapsed position substantially covering the housing or an extended position forming an enclosure for receiving aerosolized powder.

24. An apparatus as in claim 23, further comprising at least one detent pin in the housing and at least one notch in the capture chamber, with the detent pin being received into the notch when the capture chamber is in the extended position.

25. An apparatus as in claim 24, further comprising a spring for outwardly biasing the detent pin.

26. An apparatus as in claim 24, wherein the detent pin and the notch are generally V-shaped in geometry.

27. An apparatus as in claim 24, wherein the capture chamber comprises an elongate chamber body having at least one elongate ridge extending longitudinally along the body.

28. An apparatus as in claim 24, wherein the chamber body is asymmetrical in cross-sectional geometry.

29. An apparatus as in claim 17, wherein the capture chamber further includes a mouthpiece.

30. An apparatus as in claim 29, further comprising a cap removably held over the mouthpiece.

31. An apparatus as in claim 30, further comprising a seal between the cap and the mouthpiece.

32. A receptacle for holding a powdered medicament, the receptacle being adapted to be received into an aperture in a housing of an aerosolizing apparatus, the receptacle comprising: a receptacle body having a puncturable access surface; and a tab extending from the receptacle body, wherein the receptacle body may be received into the aperture with at least a portion of the tab remaining outside the housing.

33. A receptacle as in claim 32, wherein the tab includes a keyed hole adapted to receive an alignment pin in the aerosolizing apparatus.

34. An improved method for aerosolizing a powdered medicament, said method being of the type wherein the powder is entrained and suspended in a flowing gas stream, wherein the improvement comprises: providing a housing having a pressurization cylinder, a piston slidable within the cylinder, a release valve in communication with the cylinder, and a handle for axially translating the piston and for closing the release valve; translating the handle away from the housing to axially translate the piston within the cylinder to a retracted position and to close the release valve; translating the handle back toward the housing to translate the piston to a charged position and create a pressurized gas; and releasing the valve to abruptly discharge the pressurized gas.

35. An improved method as in claim 34, further comprising preventing translation of the handle in the direction of the housing until the release valve is closed.

36. An improved method as in claim 35, further comprising holding the release valve closed while translating the handle back toward the housing.

37. An improved method as in claim 34, wherein the handle is translated away from and toward the housing with the handle being generally parallel to the housing.

38. An improved method as in claim 34, further comprising supplying a generally constant force when translating the handle toward the housing when pressurizing the gas.

39. An improved method as in claim 34, further comprising introducing the powder that is suspended in the released gas into a capture chamber while simultaneously bleeding off a preselected amount of gas from the capture chamber.

40. An improved method as in claim 34, further comprising providing a transjector assembly for receiving the pressurized gas and aerosolizing the powder, and periodically removing the transjector assembly from the housing for cleaning.

41. An improved method as in claim 34, further comprising producing verbal operating instructions from the housing.

42. An improved method as in claim 34, further comprising providing a receptacle having a puncturable lid for holding the medicament and translating the receptacle toward the transjector assembly until the transjector assembly penetrates the lid.

43. An improved method as in claim 42, further comprising guiding the receptacle toward the transjector so that the transjector penetrates the lid at a known and a predictable position.

44. An improved method as in claim 42, further comprising holding the receptacle with the transjector assembly penetrating the lid until after the valve is released.

45. A method for aerosolizing a powdered medicament, said method comprising: providing receptacles having a receptacle body and a tab extending from the receptacle body, wherein the powdered medicament is held within the receptacle bodies; inserting one receptacle into a housing having an aperture, wherein the receptacle body is received within the aperture and at least a portion of the tab remains outside the housing; piercing the receptacle body and extracting the powdered medicament in a gas stream that can be inhaled; pulling on the tab to remove the receptacle from the housing.

46. A method as in claim 45, wherein the housing has a reciprocatable capture chamber for receiving the powder-bearing gas stream, and further comprising deploying the chamber prior to inserting the receptacle.

47. A method as in claim 46, wherein deploying the chamber exposes the aperture and wherein the chamber cannot be retracted until the receptacle is removed.
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