Delivery devices

• US 7,784,460 B2
• Filed: 08/16/2004
• Issued: 08/31/2010
• Est. Priority Date: 08/14/2003
• Status: Active Grant

• Current Assignee: OptiNose, Inc.
• Original Assignee: OptiNose AS (OptiNose, Inc.)
• Inventors: Djupesland, Per Gisle, Pocock, Andrew Gordon, Kay, Stuart Brian William, Murphy, Martin Joseph
• Primary Examiner(s): Douglas; Steven O
• Assistant Examiner(s): STUART, COLIN W
• Application Number:
  US10/568,391
• Publication Number:
  US 20070186927A1
• Time in Patent Office: 2,206 Days
• Field of Search: 128/203.15, 128/203.12, 128/200.14, 128/203.18, 128/203.14, 128/203.13, 128/203.19, 128/203.21, 128/203.23
• US Class Current: 128/203.18
• CPC Class Codes: A61M 11/007 Syringe-type or piston-type sprayers or atomisers
• 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 15/00 Inhalators drug delivery in endotracheal tubes A61M16/04
• CPC Class Codes: A61M 15/0018 with exhalation check valves
• CPC Class Codes: A61M 15/0021 Mouthpieces therefor
• CPC Class Codes: A61M 15/0036 hollow piercing means
• CPC Class Codes: A61M 15/0038 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 15/0091 mechanically breath-triggered
• CPC Class Codes: A61M 15/0098 Activated by exhalation
• CPC Class Codes: A61M 15/08 Inhaling devices inserted into the nose
• CPC Class Codes: A61M 2205/8281 spring operated

Abstract

A delivery device, in particular a breath-actuated nasal delivery device, for delivering substance, in particular one of a liquid, as a suspension or solution, or a powder containing a medicament, especially systemic or topical pharmaceuticals, or a vaccine to the nasal airway of a subject.

Claims

1. A breath-actuated delivery device, comprising:

a delivery unit which is actuatable to deliver substance on application of a delivery force thereto;

a loading unit which is actuatable to apply the delivery force to the delivery unit to actuate the same;

a mouthpiece through which a subject in use exhales;

an air channel which is in fluid communication with the mouthpiece; and

an actuating member which is disposed in the air channel, the actuating member comprising a flexible, bi-stable element which is actuatable, on exhalation by the subject into the mouthpiece, between a first, non-actuated state and a second, actuated state in which the actuating member actuates the loading unit to apply the delivery force to the delivery unit to actuate the same,

wherein the loading unit comprises a drive member which is actuatable from a loaded position to actuate the delivery unit, a biasing element for loading the drive member with the delivery force, and a restraining member for normally restraining the drive member in the loaded position and being configured to be released on actuation of the actuating member to the actuated state, such as to cause the biasing element to drive the drive member to actuate the delivery unit; and

wherein the restraining member comprises a tether which is broken on actuation of the actuating member.

2. The delivery device of claim 1, wherein the delivery unit comprises a pump unit.

3. The delivery device of claim 2, wherein the pump unit is configured to deliver an aerosol.

4. The delivery device of claim 2, wherein the pump unit is configured to deliver a jet.

5. The delivery device of claim 1, wherein the substance comprises a liquid.

6. The delivery device of claim 1, wherein the substance comprises a powder.

7. The delivery device of claim 1, wherein the delivery unit comprises an aerosol canister which is configured to deliver an aerosol.

8. The delivery device of claim 1, wherein the delivery unit comprises a liquid delivery unit.

9. The delivery device of claim 1, wherein the delivery unit comprises a powder delivery unit.

10. The delivery device of claim 8, wherein the delivery unit is configured to deliver an aerosol.

11. The delivery device of claim 8, wherein the delivery unit is configured to deliver a jet.

12. The delivery device of claim 1, wherein the tether comprises at least one filament.

13. The delivery device of claim 12, wherein the tether comprises a plurality of filaments.

14. The delivery device of claim 12, wherein the at least one filament comprises a strand.

15. The delivery device of claim 12, wherein the at least one filament comprises a sheet.

16. The delivery device of claim 12, wherein the at least one filament is formed of a notch-sensitive material.

17. The delivery device of claim 16, wherein the at least one filament is axially stretched such as to be notch sensitized.

18. The delivery device of claim 1, wherein the drive member and the restraining member are formed as a single integral unit.

19. The delivery device of claim 1, wherein the loading unit further comprises a loading member which is operable to load the biasing element with the delivery force.

20. The delivery device of claim 19, wherein the loading member comprises a loading button which is moved to a loaded position to load the biasing element with the delivery force and configured to be latched in the loaded position.

21. The delivery device of claim 1, wherein the bi-stable element of the actuating member has equal bi-stable states.

22. The delivery device of claim 1, wherein the bi-stable element of the actuating member has unequal bi-stable states, whereby the actuating force required to switch the bi-stable element to the actuated state is less than the force as would be required to switch the bi-stable element from the actuated state to the non-actuated state.

23. The delivery device of claim 1, wherein the actuating member further comprises a releasing element which is disposed to the bi-stable element thereof and configured to release the restraining member of the loading unit on actuation of the actuating member to the actuated state.

24. The delivery device of claim 1, wherein the loading unit further comprises a releasing element which is operative, on actuation of the actuating member to the actuated state, to release the restraining member.

25. The delivery device of claim 23, wherein the releasing element comprises a cutter element.

26. The delivery device of claim 1, wherein the actuating member is configured to substantially close the air channel such that the actuating member is actuated on generation of a predetermined pressure in the mouthpiece.

27. The delivery device of claim 1, wherein the actuating member is configured to provide for an air flow through the air channel when in the non-actuated state and close the air channel when in the actuated state.

28. The delivery device of claim 1, wherein the actuating member is configured to substantially close the air channel when in the non-actuated state and provide for an air flow through the air channel when in the actuated state.

29. The delivery device of claim 1, where the actuating member is configured to provide for an air flow at a first rate through the air channel when in the non-actuated state and an air flow at a second rate, higher than the first rate, through the air channel when in the actuated state.

30. The delivery device of claim 1, wherein the delivery device is a nasal delivery device, and further comprising:

a nosepiece for fitting to a nostril of the subject through which substance is delivered into the nasal airway of the subject.

31. The delivery device of claim 30, wherein the actuating member is configured such as to provide for an air flow through the air channel when in the non-actuated state and close the air channel when in the actuated state;

and wherein the nosepiece is in fluid communication with the air channel such that an air flow which is delivered through the air channel is directed through the nosepiece.

32. The delivery device of claim 31, further comprising:

a pressure-sensitive release mechanism for providing for operation of the actuating member when a sufficient flow cannot be achieved through the nosepiece on exhalation by the subject into the mouthpiece.

33. The delivery device of claim 32, wherein the pressure-sensitive release mechanism comprises a valve which is disposed downstream of the air channel and vents the air channel to atmosphere on generation of a predetermined pressure in the mouthpiece.

34. The delivery device of claim 33, wherein the pressure-sensitive release mechanism comprises a flexible diaphragm which is coupled to the actuating member, such that generation of a predetermined pressure in the mouthpiece acts to deflect the diaphragm and actuate the coupled actuating member.

50. A method of delivering a substance to a subject, the method comprising the steps of:

the subject obtaining a device according to any of claims 1-11, 12-17, or 18-29;

loading the drive member of the device with a predetermined delivery force;

gripping the mouthpiece of the device in the subject'"'"'s lips or teeth; and

exhaling through the mouthpiece.

51. A method of delivering a substance to the nasal airway of a subject, the method comprising the steps of:

the subject obtaining a device according to any one of claims 30-34;

loading the drive member of the device with a predetermined delivery force;

inserting the nosepiece of the device in one of the subject'"'"'s nostrils;

gripping the mouthpiece of the device in the subject'"'"'s lips or teeth; and

exhaling through the mouthpiece.

35. A delivery device, comprising:

a delivery unit which is actuatable to deliver substance on application of a delivery force thereto; and

a loading unit which is actuatable to apply the delivery force to the delivery unit to actuate the same, the loading unit comprising a drive member which is actuatable from a loaded position to actuate the delivery unit, a biasing element for loading the drive member with the delivery force, and a restraining member, comprising a tether, for normally restraining the drive member in the loaded position and being configured such that the tether is broken on actuation of the loading unit to release the drive member and cause the biasing element to drive the drive member to actuate the delivery unit.

36. The delivery device of claim 35, wherein the tether comprises at least one filament.

37. The delivery device of claim 36, wherein the tether comprises a plurality of filaments.

38. The delivery device of claim 36, wherein the at least one filament comprises a strand.

39. The delivery device of claim 36, wherein the at least one filament comprises a sheet.

40. The delivery device of claim 36, wherein the at least one filament is formed of a notch-sensitive material.

41. The delivery device of claim 40, wherein the at least one filament is axially stretched such as to be notch sensitized.

42. The delivery device of claim 35, further comprising:

an actuating member which is actuatable to break the tether of the restraining member and actuate the loading unit.

43. The delivery device of claim 42, further comprising:

a mouthpiece through which the subject in use exhales; and

an air channel which is in fluid communication with the mouthpiece; and

wherein the actuating member is disposed in the air channel such as to be actuated on exhalation by the subject, whereby the delivery device is a breath-actuated delivery device.

44. The delivery device of claim 43, wherein the actuating member comprises a flexible, bi-stable element which is actuatable, on exhalation by the subject into the mouthpiece, between a first, non-actuated state and a second, actuated state in which the actuating member actuates the loading unit to apply the delivery force to the delivery unit to actuate the same.

45. The delivery device of claim 44, wherein the actuating member further comprises a releasing element which is disposed to the bi-stable element thereof and configured to break the tether of the restraining member of the loading unit on actuation of the actuating member to the actuated state.

46. The delivery device of claim 44, wherein the loading unit further comprises a releasing element which is operative, on actuation of the actuating member to the actuated state, to break the tether of the restraining member.

47. The delivery device of claim 45, wherein the releasing element comprises a cutter element.

48. The delivery device of claim 35, wherein the delivery device is a nasal delivery device, and further comprising:

a nosepiece for fitting to a nostril of the subject through which substance is delivered into the nasal airway of the subject.

49. The delivery device of claim 48, further comprising:

a mouthpiece through which the subject in use exhales; and

an air channel which is in fluid communication with the mouthpiece; and

wherein the actuating member is disposed in the air channel such as to be actuated on exhalation by the subject, whereby the delivery device is a breath-actuated delivery device; and

wherein the nosepiece is in fluid communication with the air channel such that an air flow delivered through the air channel is directed through the nosepiece.

52. A method of delivering a substance to a subject, the method comprising the steps of:

the subject obtaining a device according to any of claims 35, 36-41, or 42;

loading the drive member of the device with a predetermined deliver force; and

actuating the loading unit of the device so as to cause the release of the drive member and actuation of the delivery unit to deliver the substance to the subject.

53. A method of delivering a substance to a subject, the method comprising the steps of:

the subject obtaining a device according to any of claims 43-47;

loading the drive member of the device with a predetermined delivery force;

gripping the mouthpiece of the device in the subject'"'"'s lips or teeth; and

exhaling through the mouthpiece so as to actuate the actuating member to cause the actuation of the loading unit.

54. A method of delivering a substance into the nasal airway of a subject, the method comprising the steps of:

the subject obtaining a device according to claim 48;

loading the drive member of the device with a predetermined delivery force;

fitting the nosepiece of the device to a nostril of the subject; and

actuating the loading unit of the device so as to cause the release of the drive member and actuation of the delivery unit to deliver the substance through the nosepiece and into the nasal airway of the subject.

55. A method of delivering a substance into the nasal airway of a subject, the method comprising the steps of:

the subject obtaining a device according to claim 49;

loading the drive member of the device with a predetermined delivery force;

gripping the mouthpiece of the device in the subject'"'"'s lips or teeth;

fitting the nosepiece of the device to a nostril of the subject; and

exhaling through the mouthpiece so as to actuate the actuating member to cause the actuation of the loading unit.