Medicament inhalation delivery devices and methods for using the same

• US 7,040,316 B2
• Filed: 03/03/2004
• Issued: 05/09/2006
• Est. Priority Date: 01/12/2001
• Status: Expired due to Term

• Current Assignee: Becton, Dickinson & Co
• Original Assignee: Becton, Dickinson & Co
• Inventors: Pettis, Ronald J., Sullivan, Vincent J., Shermer, Charles D., Bhuta, Anjana, Connelly, Robert I.
• Primary Examiner(s): Nguyen, Anhtuan T.
• Assistant Examiner(s): Erezo, Darwin P
• Application Number:
  US10/792,583
• Publication Number:
  US 20040163645A1
• Time in Patent Office: 797 Days
• Field of Search: 128/200.14, 128/200.23, 128/203.15, 128/203.21, 424/451
• US Class Current: 128/203.15
• CPC Class Codes: A61M 11/002 by flow deviation causing inertial separation of transported particles
• CPC Class Codes: A61M 11/003 by passing the aerosol trough sieves or filters
• CPC Class Codes: A61M 11/02 operated by air or other gas pressure applied to the liquid or other product to be sprayed or atomised sprayers for horticulture A01G, A01H; killing insects A01M; air humidifying by nozzles F24F6/14, F24F6/18; cooling by spraying F28B, F28C
• CPC Class Codes: A61M 15/0025 with caps
• 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 15/0031 by bursting or breaking the package, i.e. without cutting or piercing
• CPC Class Codes: A61M 15/0033 Details of the piercing or cutting 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 15/0068 Indicating or counting the number of dispensed doses or of remaining doses
• CPC Class Codes: A61M 2202/064 Powder
• CPC Class Codes: A61M 2205/075 Bulb type
• CPC Class Codes: A61M 2207/00 Methods of manufacture, assembly or production
• CPC Class Codes: B05B 11/061 characterised by the means producing the gas or vapour pressure
• CPC Class Codes: B05B 11/062 designed for spraying particulate material

Abstract

A medicament delivery device for administering a medicament to a user includes a medicament reservoir and an entrance port and an exit port each disposed adjacent the reservoir. A gas chamber disposed adjacent the entrance port. The device includes a pressurizing mechanism operable to pressurize said gas chamber to at least a prescribed pressure. A first frangible membrane extends across the entrance port and separates the reservoir from the gas chamber. A second frangible membrane extends across the exit port. When the pressurizing mechanism is attached, at least one of the first and second membranes is responsive to the prescribed pressure in the gas chamber to burst to allow gas to flow through the entrance port and the reservoir and to carry the medicament through the exit port.

Claims

1. A medicament delivery device for administering an inhalable medicament to a user, said device comprising:

a) a medicament reservoir;

b) an entrance port and an exit port each disposed adjacent said reservoir;

c) a gas chamber disposed adjacent said entrance port;

d) a pressurizing mechanism operable to pressurize said gas chamber to at least a prescribed pressure;

e) a first frangible membrane extending across said entrance port and separating said reservoir from said gas chamber; and

f) a second frangible membrane extending across said exit port;

g) a tube disposed adjacent said exit port and defining a delivery opening opposite said exit port, said delivery opening being open prior to actuation of said pressurizing mechanism;

h) a piercing member configured to initially engage said first membrane on a surface of said first membrane facing said reservoir;

i) wherein, when said pressurizing mechanism is actuated, said piercing member engages and disrupts said first membrane to allow gas to flow through said first membrane and said entrance port and said reservoir and to carry the medicament through said exit port.

2. The medicament delivery device of claim 1 wherein said tube is a diffuser tube.

3. The medicament delivery device of claim 2 including at least one impaction structure disposed between said reservoir and said delivery opening.

4. The medicament delivery device of claim 3 wherein said impaction structure includes a baffle.

5. The medicament delivery device of claim 3 wherein said impaction structure includes a screen.

6. The medicament delivery device of claim 1 including a weakening embossment formed in at least one of said first and second membranes.

7. The medicament delivery device of claim 1 wherein at least one of said first and second membranes is an oriented film.

8. The medicament delivery device of claim 7 wherein each of said first and second membranes is an oriented film and said first and second membranes are oriented at different angles.

9. The medicament delivery device of claim 1 including a removable end cap configured to rupture said second membrane upon removal of said end cap from said medicament delivery device.

10. The medicament delivery device of claim 1 including a delivery tube communicating with said second membrane.

11. The medicament delivery device of claim 10 wherein said delivery tube is foldable.

12. The medicament delivery device of claim 10 wherein said delivery tube includes a plurality of telescoping portions.

13. The medicament delivery device of claim 10 wherein said delivery tube includes an inner surface and at least one baffle extending radially inwardly from said inner surface.

14. The medicament delivery device of claim 10 wherein said delivery tube includes an inner surface and at least one helical rib extending inwardly from said inner surface.

15. The medicament delivery device of claim 10 wherein said delivery tube includes a screen mounted therein.

16. The medicament delivery device of claim 1 including a medicament disposed in said reservoir.

17. The medicament delivery device of claim 16 wherein said medicament is a dry powder.

18. The medicament delivery device of claim 1 wherein said pressurizing mechanism includes a compressible blister defining said gas chamber and operable to pressurize said gas chamber to at least said prescribed pressure.

19. The medicament delivery device of claim 18 comprising:

a) a first sheet including said compressible blister formed therein;

b) a second sheet defining said reservoir therein; and

c) an intermediate layer disposed between said first and second sheets, said first and second membranes forming a part of said intermediate layer.

20. The medicament delivery device of claim 19 wherein each of said first and second sheets is thermoformed.

21. The medicament delivery device of claim 19 including a diffuser tube integral with at least one of said first and second sheets, said diffuser tube disposed adjacent said exit port and defining a delivery opening opposite said exit port.

22. The medicament delivery device of claim 18 wherein, when said blister is compressed, the size of said entrance port increases to distort said first membrane.

23. The medicament delivery device of claim 18 wherein said blister is bellowed.

24. The medicament delivery device of claim 18 wherein said gas chamber has a volume of between about 0.2 and 10 milliliters.

25. A method for administering an inhalable medicament to a user, said method comprising the steps of:

a) providing a medicament delivery device including;

1) a medicament reservoir;

2) an entrance port and an exit port each disposed adjacent the reservoir;

3) a gas chamber disposed adjacent the entrance port;

4) a pressurizing mechanism including a compressible blister defining said gas chamber operable to pressurize the gas chamber to at least a prescribed pressure;

5) a piercing member configured to initially engage said first membrane on a surface of said first membrane facing said reservoir;

6) a first frangible membrane extending across the entrance port and separating the reservoir from the gas chamber; and

7) a second frangible membrane extending across the exit port; and

b) actuating the pressurizing mechanism to generate the prescribed pressure in the gas chamber, whereupon at the first membrane is penetrated by said piercing member to allow gas to flow past at least the first membrane and through the entrance port and the reservoir and to carry the medicament through the exit port.

26. The method of claim 25 wherein the medicament delivery device further includes a weakening embossment formed in at least one of said first and second membranes.

27. The method of claim 26 wherein said medicament is a dry powder.

28. The method of claim 26 further comprising inserting at least a portion of said medicament delivery device into a body cavity of a subject selected from the group consisting of mouth and nostril wherein the exit port of the medicament delivery device is in fluid communication with the body cavity and the medicament passes through the body cavity.

29. A method for administering an inhalable medicament to a user, said method comprising the steps of:

a) providing a medicament delivery device including;

1) a medicament reservoir;

2) an entrance port and an exit port each disposed adjacent the reservoir;

3) a compressible blister defining a gas chamber and operable to pressurize the gas chamber to at least a prescribed pressure; and

4) a frangible membrane extending across the entrance port and separating the reservoir from the gas chamber;

5) a piercing member configured to initially engage said first membrane on a surface of said first membrane facing said reservoir; and

b) compressing the blister to generate the prescribed pressure in the gas chamber, whereupon said piercing member engages and disrupts said frangible membrane to allow gas to flow past said membrane and through the entrance port and the reservoir and to carry the medicament through the exit port.

30. The method of claim 29 wherein the medicament delivery device further includes a weakening embossment formed in said membrane.

31. The method of claim 29 wherein said medicament is a dry powder.

32. The method of claim 29 further comprising inserting at least a portion of said medicament delivery device into a body cavity of a subject selected from the group consisting of mouth and nostril wherein the exit port of the medicament delivery device is in fluid communication with the body cavity and the medicament passes through the body cavity.

33. A medicament delivery device for administering an inhalable medicament to a user, comprising:

a medicament reservoir,

an inlet port communicating with said medicament reservoir,

an outlet port communicating with said medicament reservoir, and a thin polymeric frangible membrane located between said outlet port and said medicament reservoir sealing said outlet port, said delivery opening being open prior to said thin polymeric frangible membrane being broken, a piercing member located between said inlet port and said outlet port and said piercing member is configured to initially engage said thin polymeric burstable membrane on a surface of said thin polymeric burstable membrane facing said reservoir, whereby fluid pressure delivered to said reservoir will activate said piercing member to disrupt said thin polymeric burstable membrane, fluidize medicament contained in said medicament reservoir and deliver fluidized medicament to said outlet port.

34. The medicament delivery device defined in claim 33, wherein said thin polymeric frangible membrane is formed of polyurethane having a thickness of between 0.5 and 4 mils.

35. The medicament delivery device defined in claim 33, wherein said thin polymeric frangible membrane is a uniaxially oriented polyethylene film.

36. The medicament delivery device defined in claim 33, wherein said medicament reservoir includes powdered medicament.

37. The medicament delivery device defined in claim 33, wherein said medicament delivery device includes a thin polymeric film located between said inlet port and said medicament reservoir sealing said inlet port and said medicament reservoir.

38. The medicament delivery device defined in claim 37, wherein said thin polymeric frangible film and said thin polymeric frangible membrane are formed from a single sheet of polyethylene.

39. The medicament delivery device defined in claim 37, wherein said thin polymeric frangible film and said thin polymeric frangible membrane are formed of uniaxially oriented polyethylene.

40. The medicament delivery device defined in claim 39, wherein said thin polymeric film and said thin polymeric frangible membrane are formed of uniaxially oriented polyurethane oriented at different angles.

41. A medicament delivery device for administering an inhalable medicament to a user, said device comprising:

a) a medicament reservoir;

b) an entrance port and an exit port each disposed adjacent said reservoir;

c) a gas chamber disposed adjacent said entrance port;

d) a pressurizing mechanism including a compressible blister defining said gas chamber and operable to pressurize said gas chamber to at least a prescribed pressure;

e) a first frangible membrane extending across said entrance port and separating said reservoir from said gas chamber; and

f) a second frangible membrane extending across said exit port;

g) a tube disposed adjacent said exit port and defining a delivery opening opposite said exit port, said delivery opening being open prior to actuation of said pressurizing mechanism;

h) a piercing member responsive to said pressurizing mechanism;

i) wherein, when said pressurizing mechanism is actuated, said blister is compressed and the size of said entrance port is increased to distort said first membrane and said piercing member engages and disrupts said first membrane in said gas chamber to allow gas to flow through said first membrane and said entrance port and said reservoir and to carry the medicament through said exit port.

42. The medicament delivery device of claim 41 including a weakening embossment formed in at least one of said first and second membranes.

43. The method of claim 41 wherein said medicament is a dry powder.

44. The medicament delivery device of claim 41 including a removable end cap configured to rupture said second membrane upon removal of said end cap from said medicament delivery device.