Delivery device and method

• US 20070039614A1
• Filed: 05/20/2004
• Published: 02/22/2007
• Est. Priority Date: 05/20/2003
• Status: Abandoned Application

• Current Assignee: OptiNose AS (OptiNose, Inc.)
• Original Assignee: OptiNose AS (OptiNose, Inc.)
• Inventors: Djupesland, Per
• Application Number:
  US10/557,559
• Publication Number:
  US 20070039614A1
• Time in Patent Office: Days
• US Class Current: 128/200.230
• CPC Class Codes: A61M 15/0021 Mouthpieces therefor
• 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 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 16/0434 Cuffs
• CPC Class Codes: A61M 16/0493 with means for protecting the tube from damage caused by the patient's teeth, e.g. bite block
• CPC Class Codes: A61M 16/0495 with tongue depressors
• CPC Class Codes: A61M 2016/0021 with a proportional output signal, e.g. from a thermistor
• CPC Class Codes: A61M 2016/0027 pressure meter
• CPC Class Codes: A61M 2202/064 Powder
• CPC Class Codes: A61M 2202/30 Vaccines
• CPC Class Codes: A61M 2210/065 Throat; Pharynx

Abstract

A delivery device for and method of delivering substance, in particular a vaccine, to a mucosal surface within the oral cavity of a subject, the device comprising: a mouthpiece unit to be gripped in the mouth of a subject, wherein the mouthpiece unit is configured such that, on exhalation or attempted exhalation by the subject, a pressure is developed in the oral cavity which is such as to close the oropharyngeal velum of the subject; and an oral outlet unit including at least one outlet from which substance is in use delivered to a mucosal surface within the oral cavity of the subject.

Claims

1. A delivery device for delivering substance to a mucosal surface within the oral cavity of a subject, the device comprising:

a mouthpiece unit to be gripped in the mouth of a subject, wherein the mouthpiece unit is configured such that;

on exhalation or attempted exhalation by the subject, a pressure is developed in the oral cavity which is such as to close the oropharyngeal velum of the subject; and

an oral outlet unit including at least one substance outlet from which substance is in use delivered to a mucosal surface within the oral cavity of the subject during the exhalation or attempted exhalation by the subject.

2. The delivery device of claim 1, wherein the mouthpiece unit comprises a mouthpiece which includes a flow channel through which the subject in use exhales to develop an exhalation air flow.

3. The delivery device of claim 2, wherein the mouthpiece is configured to provide a flow resistance to the exhalation air flow such as to develop a pressure in the oral cavity which is such as to close the oropharyngeal velum of the subject.

4. The delivery device of claim 1, wherein the mouthpiece unit is closed to the atmosphere, whereby the subject, on attempting to exhale through the mouthpiece, develops a pressure in the oral cavity which is such as to close the oropharyngeal velum of the subject.

5. The delivery device of claim 1, wherein the mouthpiece unit comprises an oral outlet unit positioner for positioning the oral outlet unit in the oral cavity of the subject.

6. The delivery device of claim 5, wherein the oral outlet unit positioner comprises a referencing member which, when the mouthpiece unit is gripped in the mouth of the subject, engages the hard palate of the oral cavity and references the position of the oral outlet unit such as to direct the oral outlet unit at a targeted mucosal surface.

7. The delivery device of claim 6, wherein the referencing member is of fixed position relative to the oral outlet unit.

8. The delivery device of claim 6, wherein the referencing member is movable relative to the mouthpiece such as to adopt a referencing position when the mouthpiece unit is gripped in the mouth of the subject.

9. The delivery device of claim 5, wherein the oral outlet unit positioner comprises a tongue depressing member which, when the mouthpiece unit is gripped in the mouth of the subject, acts to depress the tongue.

10. The delivery device of claim 9, wherein the tongue depressing member is movable relative to the mouthpiece such as to adopt a tongue depressing position when the mouthpiece unit is gripped in the mouth of the subject.

11. The delivery device of claim 5, wherein the oral outlet unit positioner comprises at least one expandable cuff member which, when expanded, is configured to engage the hard palate of the oral cavity and reference the position of the oral outlet unit such as to direct the oral outlet unit at a targeted mucosal surface.

12. The delivery device of claim 11, wherein the at least one expandable cuff member is further configured to act to depress the tongue.

13. The delivery device of claim 11, wherein the at least one cuff member is an inflatable member.

14. The delivery device of claim 13, wherein the at least one cuff member is operably coupled to the mouthpiece unit such as to be inflated on exhalation or attempted exhalation by the subject.

15. The delivery device of claim 13, further comprising:

an inflation unit which is actuatable to inflate the at least one cuff member.

16. The delivery device of claim 15, wherein the inflation unit comprises a compressible balloon member which is fluidly connected to the at least one cuff member.

17. The delivery device of claim 5, wherein the oral outlet unit positioner comprises a sucker element which, when sucked, is configured to engage the hard palate of the oral cavity and reference the position of the oral outlet unit such as to direct the oral outlet unit at a targeted mucosal surface.

18. The delivery device of claim 17, wherein the sucker element is further configured to act to depress the tongue.

19. The delivery device of claim 17, wherein the sucker element is an inflatable member.

20. The delivery device of claim 19, further comprising:

an inflation unit which is actuatable to inflate the sucker element.

21. The delivery device of claim 20, wherein the inflation unit comprises a compressible balloon member which is fluidly connected to the sucker element.

22. The delivery device of claim 1, further comprising:

a delivery unit comprising a substance supply unit which is actuatable to deliver substance from the at least one substance outlet.

23. The delivery device of claim 22, wherein the delivery unit is a breath-actuated unit.

24. The delivery device of claim 23, wherein the delivery unit includes a trigger unit to actuate the same on generation of a predeterminable pressure at the mouthpiece unit.

25. The delivery device of claim 23, wherein the delivery unit includes a trigger unit to actuate the same on generation of a predeterminable flow rate through the mouthpiece unit.

26. The delivery device of claim 22, wherein the delivery unit is a manually-actuated unit.

27. The delivery device of claim 22, wherein the delivery unit further comprises a reflex-inducing fluid delivery unit for delivering a reflex-inducing fluid to the subject.

28. The delivery device of claim 22, wherein the oral outlet unit includes at least one reflex-inducing fluid outlet from which a reflex-inducing fluid is in use delivered to the oral cavity of the subject, and the delivery unit comprises a reflex-inducing fluid supply unit for supplying a reflex-inducing fluid to the at least one reflex-inducing fluid outlet.

29. The delivery device of claim 1, further comprising:

a nosepiece unit for fitting to a nostril of the subject; and

a nasal outlet unit for delivering substance to the nasal airway of the subject.

30. The delivery device of claim 29, wherein the nasal outlet unit includes at least one substance outlet for delivering substance to the nasal airway of the subject.

31. The delivery device of claim 30, further comprising:

a delivery unit comprising a substance supply unit which is actuatable to deliver substance from the at least one substance outlet of the oral outlet unit and the at least one substance outlet of the nasal outlet unit.

32. The delivery device of claim 30, further comprising:

a delivery unit comprising a first substance supply unit for delivering substance to the at least one outlet of the oral outlet unit and a second substance supply unit for delivering substance to the at least one substance outlet of the nasal outlet unit.

33. The delivery device of claim 1, wherein the mucosal surface is of a lymphoid structure.

34. The delivery device of claim 33, wherein the lymphoid structure is at least one of the palatine tonsils, the lingual tonsil or the pharyngeal lymphatic tissue.

35. The delivery device of claim 1, wherein the substance is a vaccine.

36. The delivery device of claim 1, wherein the substance is a medicament.

37. A delivery device for delivering substance to a mucosal surface within the oral cavity of a subject, the device comprising:

a mouthpiece unit for fitting to the mouth of a subject; and

an oral outlet unit including at least one substance outlet from which substance is in use delivered to a mucosal surface within the oral cavity of the subject.

38. The delivery device of claim 37, further comprising a delivery unit which is actuatable to deliver substance from the at least one substance outlet.

39. The delivery device of claim 38, wherein the delivery unit comprises a metering unit which is actuatable to meter a volume of substance from the at least one substance outlet.

40. The delivery device of claim 38, wherein the delivery unit comprises a gas supply unit which is actuatable to deliver a gas flow to expel substance from the at least one substance outlet.

41. The delivery device of claim 40, wherein the oral outlet unit includes a substance supply channel in fluid communication with the at least one substance outlet in which an amount of substance is contained.

42. The delivery device of claim 37, wherein the oral outlet unit includes at least one reflex-inducing fluid outlet from which a reflex-inducing fluid is in use delivered to the oral cavity of the subject.

43. The delivery device of claim 42, wherein the delivery unit comprises a gas supply unit which is actuable to deliver a gas flow to expel substance from the at least one substance outlet and a gas flow from the at least one reflex-inducing fluid outlet.

44. The delivery device of claim 37, wherein the mouthpiece unit comprises an inflatable body.

45. The delivery device of claim 44, wherein the delivery unit comprises a gas supply unit which is actuable to deliver a gas flow to expel substance from the at least one substance outlet and inflate the inflatable body.

46. The delivery device of claim 44, wherein the inflatable body comprises a sucker element which, when sucked, is configured to engage the hard palate of the oral cavity and reference the position of the oral outlet unit such as to direct the oral outlet unit at a targeted mucosal surface.

47. The delivery device of claim 37, wherein the mouthpiece unit comprises a sucker element which is configured to engage the hard palate of the oral cavity and reference the position of the oral outlet unit such as to direct the oral outlet unit at a targeted mucosal surface.

48. The delivery device of claim 46, wherein the sucker element is further configured to act to depress the tongue.

60. The delivery device of claim 47, wherein the sucker element is further configured to act to depress the tongue.

49-59. -59. (canceled)

61. A delivery device for delivering substance to a mucosal surface within the oral cavity of a subject, the device comprising:

a mouthpiece unit for fitting to the mouth of a subject; and

an oral outlet unit including at least one substance outlet from which substance is in use delivered to a mucosal surface within the oral cavity of the subject, and at least one reflex-inducing fluid outlet from which a reflex-inducing fluid is in use delivered to the oral cavity of the subject.

62. A method of delivering substance to a mucosal surface within the oral cavity of a subject, the method comprising the steps of:

a subject exhaling or attempting to exhale into a mouthpiece unit to develop a pressure in the oral cavity which is such as to close the oropharyngeal velum of the subject; and

delivering substance to a mucosal surface within the oral cavity of the subject.

63. The method of claim 62, wherein the mouthpiece unit is open such as to provide for an exhalation air flow therefrom on exhalation by the subject into the mouthpiece.

64. The method of claim 62, wherein the mouthpiece unit is closed such as to provide for no exhalation air flow on attempted exhalation by the subject.

65. The method of claim 62, wherein the mucosal surface is of a lymphoid structure.

66. The method of claim 65, wherein the lymphoid structure is at least one of the palatine tonsils, the lingual tonsil or the pharyngeal lymphatic tissue.

67. The method of claim 62, wherein the substance is a vaccine.

68. The method of claim 62, wherein the substance is a medicament.

69. A method of delivering substance to a mucosal surface within the oral cavity of a subject, the method comprising the steps of:

providing a delivery device comprising a mouthpiece unit for fitting to the mouth of a subject, and an oral outlet unit including at least one substance outlet from which substance is deliverable;

fitting the mouthpiece unit in the mouth of the subject; and

delivering substance to a mucosal surface within the oral cavity of the subject.