Inhalation devices and systems and methods including the same

• US 9,364,622 B2
• Filed: 04/15/2013
• Issued: 06/14/2016
• Est. Priority Date: 04/20/2012
• Status: Active Grant

• Current Assignee: Cerecor Inc.
• Original Assignee: FSC Laboratories,Inc
• Inventors: Steelman, Peter Wayne, Flynn, James Edward, Zeis, John, Worley-Ham, Karla
• Primary Examiner(s): Dixon, Annette
• Application Number:
  US13/862,533
• Publication Number:
  US 20130276781A1
• Time in Patent Office: 1,156 Days
• Field of Search: 128/200.12, 128/200.14, 128/200.22, 128/200.23, 128/203.12, 128/203.28, 128/203.29, 128/204.11
• US Class Current: 1/1
• CPC Class Codes: A61M 15/0013 with inhalation check valves
• CPC Class Codes: A61M 15/0016 located downstream of the dispenser, i.e. traversed by the product
• CPC Class Codes: A61M 15/0018 with exhalation check valves
• CPC Class Codes: A61M 15/0021 Mouthpieces therefor
• CPC Class Codes: A61M 15/0023 retractable
• CPC Class Codes: A61M 15/0068 Indicating or counting the number of dispensed doses or of remaining doses
• CPC Class Codes: A61M 15/0071 having a display or indicator
• CPC Class Codes: A61M 15/008 Electronic counters
• CPC Class Codes: A61M 15/0081 Locking means
• CPC Class Codes: A61M 15/0086 Inhalation chambers
• CPC Class Codes: A61M 15/0088 with variable volume
• CPC Class Codes: A61M 15/009 using medicine packages with incorporated spraying means, e.g. aerosol cans pocket atomiser of the injector type A61M11/08
• CPC Class Codes: A61M 16/107 in the inspiratory path
• CPC Class Codes: A61M 16/20 Valves specially adapted to medical respiratory devices
• CPC Class Codes: A61M 16/208 Non-controlled one-way valves, e.g. exhalation, check, pop-off non-rebreathing valves
• CPC Class Codes: A61M 16/209 Relief valves

Abstract

A collapsible inhalation device for use with a metered dose inhaler (MDI) dispenser includes an outlet end member, an inlet end member and a tubular, pliable, collapsible sleeve member attached at either end to the inlet and outlet members. The outlet end member includes a mouthpiece. The inlet end member includes an inlet port and an MDI dispenser mount structure configured to receive and engage the MDI dispenser. The inhalation device is positionable in each of an open position, wherein the sleeve member defines a chamber, and a closed position, wherein the sleeve member is collapsed and enveloped by the outlet end member and the inlet end member.

Claims

1. A collapsible inhalation device for use with a metered dose inhaler (MDI) dispenser, the MDI dispenser operable to dispense a dose of a medication therefrom, the inhalation device comprising:

an outlet end member including a mouthpiece;

an inlet end member including an inlet port and an MDI dispenser mount structure configured to receive and engage the MDI dispenser; and

a tubular, pliable, collapsible sleeve member having first and second opposed ends attached to the inlet end member and the outlet end member, respectively;

wherein the inhalation device is positionable in each of an open position, wherein the outlet end member and the inlet end member are spaced apart and the sleeve member is extended such that the outlet end member, the inlet end member and the sleeve member define a chamber, and a closed position, wherein the sleeve member is collapsed and the outlet end member and the inlet end member are proximate one another and envelope the sleeve member;

wherein, when the inhalation device is in the open position with the MDI dispenser mounted in the MDI dispenser mount structure, a dose of the medication can be dispensed from the MDI dispenser into the chamber through the inlet port to mix with air in the chamber and thereby form a mixture of the air and the dose of the medication that can be inhaled by a patient from the chamber through the mouthpiece;

wherein the inhalation device includes a latch mechanism to releasably secure the outlet end member to the inlet end member when the inhalation device is in the closed position; and

wherein the inhalation device includes at least one release tab operable by a user to warp the inhalation device to actuate the latch mechanism to release the outlet end member from the inlet end member to open the inhalation device.

2. The inhalation device of claim 1 wherein the MDI dispenser includes an MDI aerosol canister mounted in an MDI holder having a dispensing section, and the inlet port and the MDI dispenser mount structure are configured to receive and engage the dispensing section such that the dispensing section extends through the inlet port.

3. The inhalation device of claim 1 wherein the outlet end member includes a one-way inhalation valve that enables outflow of air from the chamber through the mouthpiece and prevents inflow of air into the chamber through the mouthpiece.

4. The inhalation device of claim 3 wherein the outlet end member includes a one-way blowback relief valve that enables outflow of air from the mouthpiece through the one-way blowback relief valve and prevents inflow of ambient air into the mouthpiece through the one-way blowback relief valve.

5. The inhalation device of claim 3 wherein the mouthpiece includes a grill configured to catch and prevent a component of the one-way inhalation valve from being inhaled through the mouthpiece.

6. The inhalation device of claim 1 wherein the sleeve member is substantially cylindrical when the inhalation device is in the open position.

7. The inhalation device of claim 1 wherein the inlet end member includes a ring member to which the sleeve member is affixed, and a cover member mounted on the ring member, wherein the cover member is removable from and replaceable on the ring member to provide access to the interior of the inhalation device for cleaning.

8. The inhalation device of claim 7 wherein the cover member is formed of a first material including a resilient, deformable elastomer, and the ring member is formed of a second material more rigid than the first material.

9. The inhalation device of claim 1 wherein the sleeve member is formed of a polymeric film having a thickness in the range of from about 4 to 8 mil.

10. The inhalation device of claim 9 wherein the polymeric film has a thickness in the range of from about 4 to 6 mil.

11. The inhalation device of claim 1 wherein the sleeve member is formed of a low density polyethylene (LDPE) film.

12. The inhalation device of claim 11 wherein the LDPE film is an anti-static LDPE film having a surface resistivity of 1×

10¹² Ohms/square or less as measured according to ASTM D257-07.

13. The inhalation device of claim 1 wherein at least a portion of at least one of the outlet end member and the inlet end member is formed of a polymeric material blended and/or coated with a supplemental material that imparts an anti-static property to the polymeric material.

14. The inhalation device of claim 1 wherein one of the outlet end member and the inlet end member includes an annular ring member, the ring member having a radially outwardly facing outer attachment surface and defining a through passage, wherein the sleeve member is bonded to the outer attachment surface and extends through the through passage of the ring member to attach to the other of the outlet end member and the inlet end member.

15. The inhalation device of claim 14 wherein the sleeve member is heat welded to the outer attachment surface.

16. The inhalation device of claim 1 wherein the outlet end member includes a body and the mouthpiece is hingedly coupled to the body to rotate between an extended, deployed position and a retracted, stored position.

17. The inhalation device of claim 1 wherein, when the inhalation device is in the closed position, the outlet end member and the inlet end member fully envelope the sleeve member.

18. The inhalation device of claim 1 wherein:

the latch mechanism includes a first coupling feature on the outlet end member and a second coupling feature on the inlet end member;

in the closed position, the first and second coupling features are engaged with one another to secure the inhalation device in the closed position; and

when the at least one release tab is operated by the user to actuate the latch mechanism to release the outlet end member from the inlet end member to open the inhalation device, the first and second coupling features are thereby disengaged with one another.

19. A method for administering a dose of a medication to a patient from a metered dose inhaler (MDI) dispenser, the method comprising:

a) providing a collapsible inhalation device including;

an outlet end member including a mouthpiece;

an inlet end member including an inlet port and an MDI dispenser mount structure configured to receive and engage the MDI dispenser; and

a tubular, pliable, collapsible sleeve member having first and second opposed ends attached to the inlet end member and the outlet end member, respectively;

wherein the inhalation device is positionable in each of an open position, wherein the outlet end member and the inlet end member are spaced apart and the sleeve member is extended such that the outlet end member, the inlet end member and the sleeve member define a chamber, and a closed position, wherein the sleeve member is collapsed and the outlet end member and the inlet end member are proximate one another and envelope the sleeve member;

wherein the inhalation device includes a latch mechanism to releasably secure the outlet end member to the inlet end member when the inhalation device is in the closed position; and

wherein the inhalation device includes at least one release tab operable by a user to warp the inhalation device to actuate the latch mechanism to release the outlet end member from the inlet end member to open the inhalation device;

b) placing the inhalation device in the open position, including using the at least one release tab to warp the inhalation device to actuate the latch mechanism to release the outlet end member from the inlet end member to open the inhalation device;

c) mounting the MDI dispenser in the MDI dispenser mount structure; and

thereafter;

d) dispensing a dose of the medication from the MDI dispenser into the chamber through the inlet port to mix with air in the chamber and thereby form a mixture of the air and the dose of the medication that can be inhaled by a patient from the chamber through the mouthpiece.

20. The method of claim 19 wherein, when the inhalation device is in the closed position, the outlet end member and the inlet end member fully envelope the sleeve member.

21. A collapsible inhalation device for use with a metered dose inhaler (MDI) dispenser, the MDI dispenser operable to dispense a dose of a medication therefrom, the inhalation device comprising:

a rigid, unitary outlet end member including a mouthpiece;

an inlet end member including an inlet port and an MDI dispenser mount structure configured to receive and engage the MDI dispenser; and

a tubular, pliable, collapsible sleeve member having first and second opposed ends attached to the inlet end member and the outlet end member, respectively, to define therewith a chamber;

wherein, when the MDI dispenser is mounted in the MDI dispenser mount structure, a dose of the medication can be dispensed from the MDI dispenser into the chamber through the inlet port to mix with air in the chamber and thereby form a mixture of the air and the dose of the medication that can be inhaled by a patient from the chamber through the mouthpiece;

wherein the outlet end member further includes;

a one-way inhalation valve that enables outflow of air from the chamber through the mouthpiece and prevents inflow of air into the chamber through the mouthpiece; and

a one-way blowback relief valve that enables outflow of air from the mouthpiece through the one-way blowback relief valve and prevents inflow of ambient air into the mouthpiece through the one-way blowback relief valve; and

wherein;

the outlet end member includes a valve member including the one-way inhalation valve;

the one-way inhalation valve is a self-sealing valve;

the outlet end member defines an exhaust port fluidly connected to the mouthpiece;

the outlet end member is configured to direct exhalation air flow from the patient through the mouthpiece, through the one-way blowback relief valve, and out through the exhaust port; and

the exhaust port and the mouthpiece are located on an axial end face of the outlet end member.

22. The inhalation device of claim 21 wherein the sleeve member is formed of a polymeric film having a thickness in the range of from about 4 to 8 mil.

23. The inhalation device of claim 21 wherein:

the outlet end member defines at least one internal conduit fluidly connecting the mouthpiece to the exhaust port; and

the outlet end member is configured to direct exhalation air flow from the patient through the mouthpiece, through the one-way blowback relief valve, through the at least one internal conduit, and out through the exhaust port.

24. The inhalation device of claim 21 wherein:

the outlet end member includes a mouthpiece member and a backplate, and the valve member is captured between the mouthpiece member and the backplate; and

the outlet end member and the backplate define an internal conduit in the outlet end member fluidly connecting the one-way blowback relief valve to the exhaust port.

25. The inhalation device of claim 21 wherein the one-way inhalation valve is a duckbill valve.

26. The inhalation device of claim 21 wherein the valve member further includes an integral, radially extending valve flap forming a part of the one-way blowback relief valve.

27. A method for forming a collapsible inhalation device, the method comprising:

providing an end member including an annular ring member, the ring member having a radially outwardly facing outer attachment surface and defining a through passage;

providing a tubular, pliable, collapsible sleeve member having first and second sleeve sections;

bonding the first sleeve section to the outer attachment surface; and

inverting the sleeve member through itself and routing the second sleeve section through the through passage of the ring member such that the sleeve member is wrapped around the ring member.

28. The method of claim 27 wherein bonding the first sleeve section to the outer attachment surface includes heat welding the first sleeve section to the outer attachment surface.

29. The method of claim 27 wherein the step of inverting the sleeve member through itself and and routing the second sleeve section through the through passage is executed following the step of bonding the first sleeve section to the outer attachment surface.

30. A collapsible inhalation device for use with a metered dose inhaler (MDI) dispenser, the MDI dispenser operable to dispense a dose of a medication therefrom, the inhalation device comprising:

a rigid, unitary outlet end member including a mouthpiece;

an inlet end member including an inlet port and an MDI dispenser mount structure configured to receive and engage the MDI dispenser; and

a tubular, pliable, collapsible sleeve member having first and second opposed ends attached to the inlet end member and the outlet end member, respectively, to define therewith a chamber;

wherein, when the MDI dispenser is mounted in the MDI dispenser mount structure, a dose of the medication can be dispensed from the MDI dispenser into the chamber through the inlet port to mix with air in the chamber and thereby form a mixture of the air and the dose of the medication that can be inhaled by a patient from the chamber through the mouthpiece;

wherein the outlet end member further includes;

a one-way inhalation valve that enables outflow of air from the chamber through the mouthpiece and prevents inflow of air into the chamber through the mouthpiece; and

a one-way blowback relief valve that enables outflow of air from the mouthpiece through the one-way blowback relief valve and prevents inflow of ambient air into the mouthpiece through the one-way blowback relief valve; and

wherein;

the outlet end member includes a valve member including the one-way inhalation valve;

the one-way inhalation valve is a self-sealing valve;

the valve member is unitary;

the valve member further includes an integral, radially extending valve flap forming a part of the one-way blowback relief valve;

the outlet end member defines an exhaust port;

the valve flap is positioned in a closed position wherein the valve flap blocks air from entering the mouthpiece through the exhaust valve; and

opening of the valve flap permits exhalation air from the patient to flow through the mouthpiece and out through the exhaust port.

31. The inhalation device of claim 30 wherein the valve member is monolithic.

32. The inhalation device of claim 30 wherein:

the outlet end member defines at least one internal conduit fluidly connecting the mouthpiece to the exhaust port; and

the outlet end member is configured to direct exhalation air flow from the patient through the mouthpiece, through the one-way blowback relief valve, through the at least one internal conduit, and out through the exhaust port.