Apparatus and methods for dispersing dry powder medicaments

• US 5,740,794 A
• Filed: 06/07/1995
• Issued: 04/21/1998
• Est. Priority Date: 09/21/1994
• Status: Expired due to Term

• Current Assignee: Novartis Pharma AG (Novartis Ag)
• Original Assignee: Inhale Therapeutic Systems Co.
• Inventors: Smith, Adrian E., Etter, Jeffrey W., Axford, George S., Burr, John D., Anthony, Jack M.
• Primary Examiner(s): Asher, Kimberly L.
• Application Number:
  US08/487,184
• Time in Patent Office: 1,049 Days
• Field of Search: 128/200.22, 128/203.15, 128/203.21, 128/203.23, 128/203.24, 128/203.28, 128/202.22
• US Class Current: 128/203.15
• CPC Class Codes: A61M 15/0036 hollow piercing means
• CPC Class Codes: A61M 15/004 with fixed piercing or cutting means
• CPC Class Codes: A61M 15/0041 with movable piercing or cutting means
• CPC Class Codes: A61M 15/0045 using multiple prepacked dosages on a same carrier, e.g. blisters
• CPC Class Codes: A61M 15/0051 the dosages being arranged on a tape, e.g. strips
• CPC Class Codes: A61M 15/0055 the used dosages being coiled
• CPC Class Codes: A61M 15/0086 Inhalation chambers
• CPC Class Codes: A61M 2202/064 Powder
• CPC Class Codes: A61M 2205/0233 Conductive materials, e.g. antistatic coatings for spark prevention
• CPC Class Codes: A61M 2205/073 Syringe, piston type
• CPC Class Codes: A61M 2205/6045 having complementary physical shapes for indexing or registration purposes

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.

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 powdered medicament, 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 valve closing mechanism operably attached to the handle, wherein movement of the handle in one direction moves the valve closing mechanism to engage and close the valve in a stable, closed position and movement of the handle in another direction axially translates the piston within the cylinder to produce the pressurized gas while the valve remains in the stable closed position to maintain the gas under pressure until released.

2. An improved apparatus as in claim 1, wherein the release valve comprises a valve stem connected to a valve popper, wherein the valve closing mechanisms 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, 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.

5. 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.

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

7. 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.

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 a 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 powdered medicament from the receptacle is extracted through the tube and dispersed in the flowing compressed gas to form an 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 penetrating structures, and wherein the penetrating structures are each disposed at an oblique angle relative to the access surface of the receptacle when the penetrating structures 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. 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, wherein the access surface is constructed of a material which will peel back when penetrated at an angle with a pointed structure; 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, wherein the tab includes a keyed hole adapted to receive a keyed alignment pin in the aerosolizing apparatus.

18. 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 operably engageable with the valve for axially translating the piston and for engaging and closing the release valve;

moving the handle away from the housing to axially translated the piston within the cylinder to a retracted position and to engage and close the release valve in a stable, closed position;

moving the handle back toward the housing to translate the piston to a charged position and create a pressurized gas while the valve remains in the stable, closed position to maintain the gas under pressure until separately released; and

separately releasing the valve to abruptly discharge the pressurized gas.

19. An improved method as in claim 18, further comprising preventing translation of the handle in the direction of the housing until the release valve is closed.

20. An improved method as in claim 19, further comprising holding the release valve closed while translating the handle back toward the housing.

21. An improved method as in claim 18, wherein the handle is translated away from and toward the housing with the handle being generally parallel to the housing.

22. An improved method as in claim 18, further comprising supplying a generally constant force when translating the handle toward the housing when pressurizing the gas.

23. An improved method as in claim 18, 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.

24. An improved method as in claim 18, further comprising providing a multi-flow ejector assembly for receiving the pressurized gas and aerosolizing the powder, and periodically removing the multi-flow ejector assembly from the housing for cleaning.

26. An improved method as in claim 20, further comprising guiding the receptacle toward the multi-flow ejector assembly so that the multi-flow ejector assembly penetrates the lid at a known and a predictable position.

28. An improved method as in claim 18, further comprising producing verbal operating instructions from the housing.

25. An improved method as in claim 25, further comprising providing a receptacle having a puncturable lid for holding the medicament and translating the receptacle toward the multi-flow ejector assembly until the multi-flow ejector assembly penetrates the lid.

27. An improved method as in claim 25, further comprising holding the receptacle with the multi-flow ejector assembly penetrating the lid until after the valve is released.

29. 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; and

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.

30. A method as in claim 29, wherein deploying the chamber exposes the aperture and wherein the chamber cannot be retracted until the receptacle is removed.

31. 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 powdered medicament, 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 movement of the handle closes the valve and axially translates the piston within the cylinder to produce the pressurized gas;

wherein the handle assembly includes four linkages for attaching the handle to the housing, wherein the handle may be moved radially outward and radially inward relative to the housing with a generally constant force.

32. 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;

moving the handle away from the housing to axially translate the piston within the cylinder to a retracted position and to close the release valve;

moving the handle back toward the housing to translate the piston to a charged position and create a pressurized gas wherein the handle resists the movement toward the housing with a generally constant resistive force;

releasing the valve to abruptly discharge the pressurized gas; and

supplying a generally constant force when moving the handle toward the housing when pressurizing the gas.