Dry powder dispersing apparatus and methods for their use

• US 6,257,233 B1
• Filed: 05/14/1999
• Issued: 07/10/2001
• Est. Priority Date: 06/04/1998
• Status: Expired due to Term

• Current Assignee: Novartis Pharma AG (Novartis Ag)
• Original Assignee: Inhale Therapeutic Systems Co.
• Inventors: Hall, Randy K., Smith, Adrian E., Axford, George S., Snyder, Herman, Schuler, Carlos, Ray, Charles, Burr, John D.
• Primary Examiner(s): Lewis, Aaron J.
• Assistant Examiner(s): MITCHELL, TEENA KAY
• Application Number:
  US09/312,434
• Time in Patent Office: 788 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 15/0028 using prepacked dosages, one for each application, e.g. capsules to be perforated or broken-up
• CPC Class Codes: A61M 15/0036 hollow piercing means
• CPC Class Codes: A61M 15/0086 Inhalation chambers
• CPC Class Codes: A61M 2202/064 Powder
• CPC Class Codes: A61M 2205/07 having air pumping means
• CPC Class Codes: A61M 2205/073 Syringe, piston type
• CPC Class Codes: B05B 11/062 designed for spraying particulate material

Abstract

The invention provides various apparatus and methods for aerosolizing a powdered medicament. In one exemplary embodiment, an apparatus includes a pressurization cylinder, and a piston which is slidable within the cylinder to pressurize a gas. A handle is coupled to the piston and is movable between an extended position and a home position to pressurize the gas. An aerosolizing mechanism is included and is configured to aerosolize a powdered medicament that is held within a receptacle with pressurized gas from the cylinder. A carriage assembly is included to receive the receptacle and to couple the receptacle to the aerosolizing mechanism. A first and a second interlock are operably engageable with the carriage assembly to prevent coupling of the receptacle with the aerosolization mechanism. The first interlock is released to allow movement of the carriage upon movement of the handle to the extended position. The second interlock remains engaged if the receptacle is only partially inserted into the carriage assembly.

Claims

1. An apparatus for aerosolizing a powdered medicament, the apparatus comprising:

a pressurization cylinder,

a piston slidable within the cylinder to pressurize a gas within the cylinder;

a handle coupled to the cylinder, the handle being movable between an extended position and a home position to pressurize the gas within the cylinder;

an aerosolizing mechanism adapted to aerosolize a powdered medicament that is held within a receptacle with pressurized gas from the cylinder;

a carriage assembly adapted to receive the receptacle and to couple the receptacle to the aerosolizing mechanism; and

a first and a second interlock which are operably engageable with the carriage assembly to prevent coupling of the receptacle with the aerosolizing mechanism, wherein the first interlock is released to allow movement of the carriage upon movement of the handle to the extended position, and wherein the second interlock is engaged when the receptacle is partially inserted into the carriage assembly.

2. An apparatus as in claim 1, further comprising a catch which engages the carriage assembly when moved to couple the receptacle to the aerosolizing mechanism, and a release button to release the catch from the carriage assembly.

3. An apparatus as in claim 1, further comprising a valve disposed in an airway between the cylinder and the aerosolizing mechanism, wherein the valve has an open position and a closed position, and wherein the valve is generally in the closed position during extension of the handle to the extended position.

4. A method for aerosolizing a powdered medicament that is held within a receptacle, the method comprising:

inserting the receptacle into a carriage assembly until a first interlock is released from the carriage assembly;

extending a handle to a fully extended position to release a second interlock from the carriage assembly;

retracting the handle to a retracted position to produce a charge of pressurized gas; and

operating a fire button to move the carriage assembly toward an aerosolizing mechanism until the receptacle is coupled with the aerosolizing mechanism and until the charge of pressurized gas is released to aerosolize the powdered medicament within the receptacle.

5. An apparatus for aerosolizing a powdered medicament, the apparatus comprising:

a housing;

a pressurization cylinder;

a piston slidable within the cylinder to pressurize a gas within the cylinder, wherein the piston is pivotally attached to the housing;

a handle operably attached to the housing and the cylinder to move the cylinder relative to the piston to pressurize a gas within the cylinder; and

an aerosolization mechanism to receive gas from the cylinder to aerosolize a powdered medicament.

6. An apparatus as in claim 5, further comprising a linkage disposed between the handle and the cylinder, wherein the linkage is pivotally attached to the housing and the cylinder.

7. An apparatus as in claim 5, wherein the housing has a top end and a bottom end, wherein the aerosolizing mechanism is disposed near the top end, and wherein the piston is pivotally attached to the housing at the bottom end.

8. An apparatus as in claim 5, further comprising a one-way check valve disposed in the piston.

9. An apparatus as in claim 5, further comprising a valve disposed in an airway between the piston and the aerosolizing mechanism, wherein the valve has an open position and a closed position, and wherein the valve is in the closed position during extension of the handle to an extended position.

10. A system for aerosolizing a powdered medicament, the system comprising:

a receptacle having a powdered medicament;

a carriage having an opening to receive the receptacle;

an aerosolizing mechanism to aerosolize the medicament in the receptacle upon delivery of the receptacle to the aerosolizing mechanism by the carriage; and

an interlock which is movable to engage the carriage to prevent movement of the carriage toward the aerosolizing mechanism, wherein the interlock engages the carriage when the receptacle is not fully inserted into the carriage.

11. A system as in claim 10, wherein the receptacle has a front end, a back end, and a cavity which holds the medicament, wherein the front end includes at least one notch, and wherein the carriage includes a key such that the receptacle is fully insertable into the carriage only if the notch is aligned with the key.

12. A system as in claim 11, further comprising a sensor arm having a roller, wherein the interlock includes a latch, and wherein the roller rolls over the cavity during insertion of the receptacle into the carriage to move the sensor arm against the interlock to cause the latch to engage the carriage until the roller rolls over the entire cavity.

13. A system as in claim 12, wherein the sensor arm defines a well which receives the cavity when the receptacle is fully inserted, and wherein the well aligns the cavity with the aerosolizing mechanism.

14. A device for aerosolizing a powdered medicament, the device comprising:

a housing;

a capture chamber extending from the housing;

an aerosolizing mechanism disposed in the housing to introduce a powdered medicament into the capture chamber, wherein the aerosolizing mechanism includes air channels to allow air to enter into the capture chamber when a patient inhales to extract the powdered medicament from the capture chamber, and wherein the aerosolizing mechanism further includes a structure to distribute air entering into the capture chamber through the air channels such that the powdered medicament is removed from the capture chamber as a bolus that is substantially unmixed with the entering air.

15. A device as in claim 14, wherein the capture chamber has a center, wherein the aerosolizing mechanism is offset from the center, and wherein the structure is fashioned to distribute more air to regions of the capture chamber which are on an opposite side of the center.

16. A device as in claim 14, wherein the structure is further configured to distribute the air into the chamber such that the bolus is extracted before substantially any of the entering air is extracted from the capture chamber.

17. A device as in claim 14, wherein the structure comprises a curved flange member.

18. A device as in claim 14, wherein the aerosolizing mechanism defines a cylindrical passage through which the powdered medicament passes to reach to capture chamber, and wherein a top end of the housing is generally perpendicular to a distal end of the passage.

19. A device as in claim 14, further comprising a flexible seal coupled to the housing to provide a seal with the capture chamber.

20. A method for supplying a powdered medicament to a patient, the method comprising:

dispersing a powdered medicament within a capture chamber;

inhaling from the capture chamber to extract the powdered medicament; and

allowing air to enter the capture chamber in a manner such that the powdered medicament is extracted from the chamber in a bolus followed by the entering air, wherein the air entering step comprises regulating the pressure of the entering air.

21. A method for supplying a powdered medicament to a patient, the method comprising:

dispersing a powdered medicament within a capture chamber;

inhaling from the capture chamber to extract the powdered medicament; and

allowing air to enter the capture chamber in a manner such that substantially none of the incoming air mixes with the powdered medicament as the powdered medicament is extracted from the capture chamber, wherein the air entering step further comprises diverting the entering air into air channels with an air flow divider.

22. A device for aerosolizing a powdered medicament, the device comprising:

a housing having at least one piercing element which is adapted to pierce a hole into a receptacle containing a powdered medicament;

a core which is insertable into the housing, the core having an extraction lumen and at least one air channel which is aligned with the piercing element when the core is inserted into the housing; and

a source of pressurized gas to extract the powdered medicament through the extraction lumen when the extraction lumen is inserted into the receptacle.

23. An apparatus for aerosolizing a powdered medicament, the apparatus comprising:

a pressurization cylinder;

a piston slidable within the cylinder to pressurize a gas within the cylinder;

a handle coupled to the cylinder, the handle being movable between an extended position and a home position to pressurize the gas within the cylinder;

an aerosolizing mechanism adapted to aerosolize a powdered medicament that is held within a receptacle with pressurized gas from the cylinder; and

an interlock which prevents coupling of the aerosolizing mechanism with the receptacle until the handle is moved to the extended position.