Nasal devices

• US 20050072430A1
• Filed: 06/12/2002
• Published: 04/07/2005
• Est. Priority Date: 06/12/2001
• Status: Active Grant

• Current Assignee: OptiNose, Inc.
• Original Assignee: OptiNose AS (OptiNose, Inc.)
• Inventors: Djupesland, Per Gisle
• Granted Patent: US 7,975,690 B2
• Time in Patent Office: Days
• US Class Current: 128/206.110
• CPC Class Codes: A61M 15/0021 Mouthpieces therefor
• 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 2202/064 Powder
• CPC Class Codes: A61M 2210/0618 Nose
• CPC Class Codes: A61M 2210/0625 Mouth
• CPC Class Codes: A61P 27/16 Otologicals
• CPC Class Codes: A61P 29/00 Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
• CPC Class Codes: A61P 37/08 Antiallergic agents antiasthmatic agents A61P11/06; ophthalmic antiallergics A61P27/14

Abstract

The present invention relates to a nasal delivery device for and a method of delivering a 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 nasal delivery device for delivering substance to a nasal airway of a subject, comprising:

a nosepiece for fitting to a nostril of a subject, the nosepiece including a nozzle through which substance is in use delivered to the nasal airway, and at least one inflatable cuff member which is configured to be inflated subsequent to exhalation by the subject; and

a delivery unit for delivering substance through the nozzle of the nosepiece.

2. The delivery device of claim 1, wherein the at least one inflatable cuff member is configured to be inflated in response to exhalation by the subject.

3. The delivery device of claim 1 or 2, further comprising:

a mouthpiece unit through which the subject in use exhales to cause closure of the oropharyngeal velum of the subject.

4. The delivery device of claim 3, further comprising:

a flow channel fluidly connecting the nosepiece and the mouthpiece unit, whereby exhaled air from an exhalation breath is delivered through the nosepiece.

5. The delivery device of claim 3, further comprising:

a flow channel fluidly connected to the nosepiece through which a gas flow, separate to an exhaled air flow from an exhalation breath of the subject, is in use delivered to the nosepiece; and

a gas supply unit for supplying a gas flow to the flow channel.

6. The delivery device of claim 1, wherein the delivery unit includes a dosing unit for supplying at least one substance.

7. The delivery device of claim 6, wherein the dosing unit comprises a nebulizer for supplying an aerosol.

8. The delivery device of claim 6, wherein the dosing unit comprises an aerosol canister for supplying an aerosol.

9. The delivery device of claim 6, wherein the dosing unit comprises a delivery pump unit for supplying one of an aerosol or a jet.

10. The delivery device of claim 9, wherein the delivery pump unit comprises a liquid pump unit for supplying a liquid aerosol.

11. The delivery device of claim 9, wherein the delivery pump unit comprises a powder pump unit for supplying a powder aerosol.

12. The delivery device of claim 6, wherein the dosing unit comprises a powder delivery unit for delivering a powder aerosol.

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

an actuation mechanism for actuating the delivery unit in response to exhalation by the subject.

14. The delivery device of claim 1, wherein at least one of the at least one inflatable cuff member is inflatable to engage an inner wall of a nasal cavity of the subject.

15. The delivery device of claim 14, wherein the at least one inflatable cuff member is configured such as, when inflated, to provide a fluid-tight seal between the nosepiece and the inner wall of the nasal cavity of the subject.

16. The delivery device of claim 1, wherein the at least one cuff member is configured such as, when inflated, to direct at least a distal end of the nozzle towards a site in the nasal airway of the subject.

17. The delivery device of claim 16, wherein the at least one cuff member is one or both of shaped and sized such as, when inflated, to direct at least a distal end of the nozzle to a site in the nasal airway of the subject.

18. The delivery device of claim 16, wherein the site includes at least a part of the inferior meatus.

19. The delivery device of claim 16, wherein the site includes at least a part of the middle meatus.

20. The delivery device of claim 19, wherein the site includes an inferior part of the middle meatus.

21. The delivery device of claim 16, wherein the site includes at least a part of the superior meatus.

22. The delivery device of claim 16, wherein the site includes at least a part of the inferior nasal concha.

23. The delivery device of claim 16, wherein the site includes at least a part of the middle nasal concha.

24. The delivery device of claim 16, wherein the site includes at least a part of the superior nasal concha.

25. The delivery device of claim 16, wherein the site includes at least a part of the olfactory region.

26. The delivery device of claim 16, wherein the site includes at least sinus ostia.

27. The delivery device of claim 16, wherein the site includes at least sinus infundibulum.

28. The delivery device of claim 16, wherein the site includes at least a part of the epipharynx.

29. The delivery device of claim 16, wherein the site includes at least adenoids.

30. The delivery device of claim 16, wherein the site includes at least tubal ostia.

31. The delivery device of claim 1, wherein at least one of the at least one cuff member includes at least one lobe which, when the at least one of the at least one cuff member is inflated, extends into a region of the nasal cavity of the subject such as to at least partially obstruct the same and prevent flow thereinto.

32. The delivery device of claim 31, wherein the nasal cavity region is a lower region of the nasal cavity of the subject.

33. The delivery device of claim 31, wherein the nasal cavity region is a middle region of the nasal cavity of the subject.

34. The delivery device of claim 31, wherein the nasal cavity region is an upper region of the nasal cavity of the subject.

35. The delivery device of claim 31, wherein at least one of the at least one cuff member includes a plurality of lobes which, when the at least one of the at least one cuff member is inflated, extend into regions of the nasal cavity of the subject such as to at least partially obstruct the same and prevent flow thereinto.

36. The delivery device of claim 35, wherein the nasal cavity regions are lower and middle regions of the nasal cavity of the subject.

37. The delivery device of claim 35, wherein the nasal cavity regions are lower and upper regions of the nasal cavity of the subject.

38. The delivery device of claim 35, wherein the nasal cavity regions are middle and upper regions of the nasal cavity of the subject.

39. The delivery device of claim 1, wherein the at least one cuff member is configured to be inflated by air from exhalation breath of the subject.

40. The delivery device of claim 1, wherein the at least one cuff member is configured to be inflated by a gas source separate to the exhalation breath of the subject.

41. The delivery device of claim 1, wherein the nosepiece includes a single inflatable cuff member.

42. The delivery device of claim 41, wherein the at least one cuff member is a substantially annular member disposed about the delivery channel.

43. The delivery device of claim 1, wherein the nosepiece includes a plurality of inflatable cuff members.

44. The delivery device of claim 43, wherein the nosepiece includes a plurality of cuff members disposed about the periphery thereof.

45. The delivery device of claim 44, wherein the cuff members are disposed at one position along a length of the nozzle.

46. The delivery device of claim 44, wherein the nosepiece includes first and second cuff members in spaced positions along the length of the nozzle.

47. The delivery device of claim 46, wherein one of the cuff members is disposed at a distal end of the nozzle.

48. A nasal delivery device for delivering substance to a nasal cavity of a subject, comprising:

a nosepiece including a nozzle through which substance is in use delivered to the nasal cavity, and at least one inflatable cuff member which is configured such as, when inflated, to provide a fluid-tight seal between the nosepiece and an inner wall of the nasal cavity of the subject; and

a delivery unit for delivering substance through the nozzle of the nosepiece.

49-93. -93. (canceled)

94. A nasal delivery device for delivering substance to a nasal airway of a subject, comprising:

a nosepiece for fitting to a nostril of a subject, the nosepiece including a nozzle through which substance is in use delivered to the nasal airway, and at least one cuff member which is configured such as, when fitted in a nasal cavity of the subject, to engage an inner wall of the nasal cavity of the subject and direct at least a distal end of the nozzle towards a site in the nasal airway of the subject; and

a delivery unit for delivering substance through the nozzle of the nosepiece.

95-153. -153. (canceled)

154. A nasal delivery device for delivering substance to a nasal airway of a subject, comprising:

a nosepiece for fitting to a nostril of a subject, the nosepiece including a nozzle through which substance is in use delivered to the nasal airway, and at least one cuff member, at least one of the at least one cuff member including at least one lobe which, when the at least one of the at least one cuff member is fitted in the nasal cavity of the subject, extends into a region of the nasal cavity of the subject such as to at least partially obstruct the same and prevent flow thereinto; and

a delivery unit for delivering substance through the nozzle of the nosepiece.

155-213. -213. (canceled)

214. A nasal delivery device for delivering substance to a nasal airway of a subject, comprising:

a nosepiece for fitting to a nasal cavity of a subject, the nosepiece including a first delivery outlet through which substance is in use delivered to the nasal airway of the subject, and at least one second delivery outlet through which at least one gas flow, separate to an exhalation breath of the subject, is in use delivered to the nasal airway of the subject;

a delivery unit for delivering substance through the first delivery outlet of the nosepiece; and

a gas supply unit for supplying a flow of gas through the at least one second delivery outlet of the nosepiece.

215-251. -251. (canceled)

252. A method of delivering substance to a nasal airway of a subject, comprising:

fitting a nosepiece to a nasal cavity of a subject, the nosepiece including a nozzle through which substance is delivered to the nasal airway, and at least one inflatable cuff member;

inflating the at least one cuff member subsequent to exhalation by the subject; and

delivering substance through the nozzle of the nosepiece.

253. The method of claim 252, wherein the at least one inflatable cuff member is configured to be inflated in response to exhalation by the subject.

254. The method of claim 252 or 253, further comprising the steps of:

providing a mouthpiece unit; and

exhaling through the mouthpiece unit to cause closure of the oropharyngeal velum of the subject.

255. The method of claim 254, further comprising the step of:

providing a flow channel fluidly connecting the nosepiece and the mouthpiece unit, whereby exhaled air from an exhalation breath is delivered through the nosepiece.

256. The method of claim 254, further comprising the steps of:

providing a flow channel fluidly connected to the nosepiece through which a gas flow, separate to an exhaled air flow from an exhalation breath of the subject, is delivered to the nosepiece; and

supplying a gas flow to the flow channel.

257. The method of claim 252, further comprising the step of:

delivering the substance in response to exhalation by the subject.

258. The method of claim 252, wherein the at least one cuff member is configured such as, when inflated, to direct at least a distal end of the nozzle towards a site in the nasal airway of the subject.

259. The method of claim 258, wherein the at least one cuff member is one or both of shaped and sized such as, when inflated, to direct at least a distal end of the nozzle to a site in the nasal airway of the subject.

260. The method of claim 258, wherein the site includes at least a part of the inferior meatus.

261. The method of claim 258, wherein the site includes at least a part of the middle meatus.

262. The method of claim 261, wherein the site includes an inferior part of the middle meatus.

263. The method of claim 258, wherein the site includes at least a part of the superior meatus.

264. The method of claim 258, wherein the site includes at least a part of the inferior nasal concha.

265. The method of claim 258, wherein the site includes at least a part of the middle nasal concha.

266. The method of claim 258, wherein the site includes at least a part of the superior nasal concha.

267. The method of claim 258, wherein the site includes at least a part of the olfactory region.

268. The method of claim 258, wherein the site includes at least sinus ostia.

269. The method of claim 258, wherein the site includes at least sinus infundibulum.

270. The method of claim 258, wherein the site includes at least a part of the epipharynx.

271. The method of claim 258, wherein the site includes at least adenoids.

272. The method of claim 258, wherein the site includes at least tubal ostia.

273. The method of claim 252, wherein at least one of the at least one cuff member includes at least one lobe which, when the at least one of the at least one cuff member is inflated, extends into a region of the nasal cavity of the subject such as to at least partially obstruct the same and prevent flow thereinto.

274. The method of claim 273, wherein the nasal cavity region is a lower region of the nasal cavity of the subject.

275. The method of claim 273, wherein the nasal cavity region is a middle region of the nasal cavity of the subject.

276. The method of claim 273, wherein the nasal cavity region is an upper region of the nasal cavity of the subject.

277. The method of claim 252, wherein at least one of the at least one cuff member includes a plurality of lobes which, when the at least one of the at least one cuff member is inflated, extend into regions of the nasal cavity of the subject such as to at least partially obstruct the same and prevent flow thereinto.

278. The method of claim 277, wherein the nasal cavity regions are lower and middle regions of the nasal cavity of the subject.

279. The method of claim 277, wherein the nasal cavity regions are lower and upper regions of the nasal cavity of the subject.

280. The method of claim 277, wherein the nasal cavity regions are middle and upper regions of the nasal cavity of the subject.

281. A method of delivering substance to a nasal cavity of a subject, comprising the steps of:

fitting a nosepiece to a nasal cavity of a subject, the nosepiece including a nozzle through which substance is delivered to the nasal cavity, and at least one inflatable cuff member which is configured such as, when inflated, to provide a fluid-tight seal between the nosepiece and an inner wall of the nasal cavity of the subject; and

delivering substance through the nozzle of the nosepiece.

282-310. -310. (canceled)

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

fitting a nosepiece to a nasal cavity of a subject, the nosepiece including a nozzle through which substance is delivered to the nasal airway, and at least one cuff member which is configured such as, when fitted in the nasal cavity of the subject, to engage an inner wall of the nasal cavity of the subject and direct at least a distal end of the nozzle towards a site in the nasal airway of the subject; and

delivering substance through the nozzle of the nosepiece.

312-349. -349. (canceled)

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

fitting a nosepiece to a nasal cavity of a subject, the nosepiece including a nozzle through which substance is delivered to the nasal airway, and at least one cuff member, at least one of the at least one cuff member including at least one lobe which, when the at least one of the at least one cuff member is fitted in the nasal cavity of the subject, extends into a region of the nasal cavity of the subject such as to at least partially obstruct the same and prevent flow thereinto; and

delivering substance through the nozzle of the nosepiece.

351-388. -388. (canceled)

389. A method of delivering substance to a nasal airway of a subject, comprising the step of:

delivering substance through a first delivery outlet and at least one gas flow, separate to an exhalation breath of a subject, through at least one second delivery outlet into the nasal airway of the subject.

390-403. -403. (canceled)