Apparatus and methods for dispersing dry powder medicaments

• US 6,089,228 A
• Filed: 01/08/1998
• Issued: 07/18/2000
• Est. Priority Date: 09/21/1994
• Status: Expired due to Fees

• 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): Lewis, Aaron J.
• Assistant Examiner(s): MITCHELL, TEENA KAY
• Application Number:
  US09/004,558
• Time in Patent Office: 922 Days
• Field of Search: 128/203.15, 128/203.24, 128/203.21, 128/203.23, 128/200.22, 128/200.23
• US Class Current: 128/203.15
• CPC Class Codes: A61M 15/0036 hollow piercing 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 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

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 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 multi-flow ejector assembly held within the housing, said multi-flow ejector assembly having an air inlet path with a penetrating structure and an outlet path with a penetrating element, wherein the penetrating structure and the penetrating element are each adapted to pierce the access surface of the receptacle and wherein the multi-flow ejector assembly includes a gas flow passage which converges with the outlet path at an oblique angle, and wherein the gas flow passage is adapted to receive pressurized gas from the gas source to draw powder from the receptacle, through the outlet path and into the capture chamber.

2. An apparatus as in claim 1, wherein the multi-flow ejector 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.

3. An apparatus as in claim 1, further comprising an interface seal between the multi-flow ejector assembly and the housing, whereby pressurized gas may be passed from the housing to the multi-flow ejector assembly without substantial loss of the gas.

4. An apparatus as in claim 3, wherein the interface seal is angled relative to a central axis of the multi-flow ejector assembly.

5. An apparatus as in claim 1, further comprising a receptacle seal which is adapted to form a seal between the multi-flow ejector assembly and the receptacle.

6. An apparatus as in claim 1, wherein the multi-flow ejector assembly is keyed to be repeatedly received into the housing in a unique orientation.

7. An apparatus as in claim 1, 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.

8. An apparatus as in claim 7, 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.

9. An apparatus as in claim 8, further comprising a spring for outwardly biasing the detent pin.

10. An apparatus as in claim 8, wherein the detent pin and the notch are generally V-shaped in geometry.

11. An apparatus as in claim 8, wherein the capture chamber comprises an elongate chamber body having at least one elongate ridge extending longitudinally along the body.

12. An apparatus as in claim 8, wherein the chamber body is asymmetrical in cross-sectional geometry.

13. An apparatus as in claim 1, wherein the capture chamber further includes a mouthpiece.

14. An apparatus as in claim 13, further comprising a cap removably held over the mouthpiece.

15. An apparatus as in claim 14, further comprising a seal between the cap and the mouthpiece.

16. 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;

releasing the valve to abruptly discharge the pressurized gas; and

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.

17. A method for aerosolizing a powdered medicament, the method comprising:

inserting a bottom end of a substantially straight feed tube into a receptacle containing a powder and which includes at least one vent such that a substantially straight and direct flow path is provided between the receptacle and an outlet end of the feed tube; and

introducing a high pressure gas stream into the feed tube at an angle relative to the flow path such that the high pressure gas stream flows through at least a portion of the feed tube to draw air through the vent and then the receptacle to move the powder in the receptacle into the feed tube through the bottom end where the powder becomes entrained in the high pressure gas stream as it passes directly through the substantially straight flow path to form an aerosol.

18. A method as in claim 17, wherein the receptacle includes a penetrable lid, and further comprising piercing the lid with the bottom end of the feed tube to insert the bottom end of the feed tube into the receptacle.

19. A method as in claim 18, further comprising piercing the lid at a location spaced apart from the feed tube to form the vent.

20. A method as in claim 19, further comprising capturing the aerosolized powder in a capture chamber.

21. A method for aerosolizing a powdered medicament, the method comprising:

inserting a bottom end of a substantially straight feed tube into a receptacle containing a powder and which includes at least one vent such that a substantially straight and direct flow path is provided between the receptacle and an outlet end of the feed tube; and

introducing a high pressure gas stream into the feed tube at a location spaced below the outlet end of the feed tube such that the high pressure gas stream flows through at least a portion of the feed tube to draw air through the vent and then the receptacle to move the powder in the receptacle into the feed tube through the bottom end where the powder becomes entrained in the high pressure gas stream as it passes directly through the substantially straight flow path to form an aerosol.