Nasal delivery

• US 8,978,647 B2
• Filed: 04/07/2008
• Issued: 03/17/2015
• Est. Priority Date: 04/05/2007
• Status: Active Grant

• Current Assignee: OptiNose, Inc.
• Original Assignee: OptiNose AS (OptiNose, Inc.)
• Inventors: Djupesland, Per Gisle, Sheldrake, Colin David
• Primary Examiner(s): Ho, Tan-Uyen (Jackie) T
• Assistant Examiner(s): Han, Mark K
• Application Number:
  US12/594,361
• Publication Number:
  US 20100282246A1
• Time in Patent Office: 2,535 Days
• Field of Search: 12820011-20014, 12820021-20023, 128/203.12, 128/203.15, 128/203.18, 128/203.22, 128/203.25, 128/204.11, 128/204.12, 128/204.15, 128/207.18, 604 23- 26, 604/39, 604/41, 604 68- 72, 604/93.01, 604/94.01, 604104-109, 604244-262, 604/264, 604275-278, 606/191, 606/196, 606/197, 606/199
• US Class Current: 128/203.18
• CPC Class Codes: A61M 15/0021 Mouthpieces therefor
• 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 15/085 Fixing means therefor
• CPC Class Codes: A61M 2202/064 Powder
• CPC Class Codes: A61M 2210/0625 Mouth

Abstract

A nasal delivery device for and method of delivering substance to a nasal cavity of a subject, the delivery device comprising: a nosepiece for fitting to a nostril of a subject, wherein the nosepiece comprises a tip element which includes a delivery aperture from which substance is in use delivered into the nasal cavity, and the tip element is at least in part tapered such as to be inclined to a longitudinal axis of the nosepiece, with the delivery aperture extending both laterally across the tip element and along a longitudinal extent of the tip element; a nozzle through which substance is in use delivered, preferably substantially axially to a longitudinal axis of the nosepiece, to the respective nasal cavity; and a delivery unit for delivering substance through the nozzle of the nosepiece.

Claims

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

a nosepiece for fitting to a nostril of a subject, wherein the nosepiece comprises a tip element which includes a delivery aperture from which substance is in use delivered into the nasal cavity, and the tip element is at least in part tapered so as to be inclined to a longitudinal axis of the nosepiece, with the delivery aperture extending both laterally across the tip element and along a longitudinal extent of the tip element in relation to the longitudinal axis, wherein the tip element of the nosepiece has differing lengths adjacent forwardmost and rearwardmost sections thereof;

a nozzle through which substance is in use delivered to the respective nasal cavity; and

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

2. The delivery device of claim 1, wherein the tip element of the nosepiece has an elongate lateral section which has a longer dimension in a first, sagittal direction than a second direction orthogonal to the sagittal direction, such that, when the nosepiece is inserted in the nasal cavity of the subject, the longer dimension of the nosepiece acts to engage lower and upper surfaces of the nasal cavity.

3. The delivery device of claim 2, wherein the longer dimension of the nosepiece acts to expand the nasal cavity in the sagittal plane.

4. The delivery device of claim 2, wherein the elongate lateral section of the tip element of the nosepiece is substantially elliptical or substantially rectangular.

5. The delivery device of claim 1, wherein the tip element of the nosepiece extends substantially axially to the longitudinal axis of the nosepiece.

6. The delivery device of claim 1, wherein at least the tip element of the nosepiece has a pre-defined shape and configuration.

7. The delivery device of claim 6, wherein at least the tip element of the nosepiece comprises (i) a substantially rigid structure, (ii) a semi-rigid structure, or (iii) a flexible structure.

8. The delivery device of claim 1, wherein at least the tip element of the nosepiece has a pre-defined shape and configuration, and the nosepiece comprises an outer body part of a soft, resilient material which defines at least the tip element of the nosepiece and an inner body part which acts structurally to support the outer body part.

9. The delivery device of claim 1, wherein at least the tip element of the nosepiece is expandable so as to have an expanded lateral section following insertion into the nasal cavity.

10. The delivery device of claim 9, wherein the tip element of the nosepiece comprises a tubular section of a flexible material which is configured to expand on application of an insertion force substantially along the longitudinal axis of the nosepiece.

11. The delivery device of claim 10, wherein the tip element of the nosepiece is configured such that the delivery aperture is normally in a closed configuration and opened to an open configuration on expansion of the tip element of the nosepiece.

12. The delivery device of claim 11, wherein the delivery aperture is substantially closed in the closed configuration.

13. The delivery device of claim 10, wherein the nosepiece comprises a flexible nosepiece member which defines at least the tip element of the nosepiece and an expansion member which acts to expand the nosepiece member laterally by application of an insertion force substantially along the longitudinal axis of the nosepiece.

14. The delivery device of claim 13, wherein the expansion member comprises a coil which is disposed within the nosepiece member so as normally to have a first, flat configuration in which the nosepiece member has a contracted state and, on application of an insertion force substantially along the longitudinal axis of the nosepiece, the coil is longitudinally compressed to expand the coil and configure the nosepiece member in an expanded state.

15. The delivery device of claim 13, wherein the expansion member comprises a plurality of elongate elements which are disposed within the nosepiece member so as normally to have a first, flat configuration in which the nosepiece member has a contracted state and, on application of an insertion force substantially along the longitudinal axis of the nosepiece, at least one of the elongate elements is longitudinally displaced relative to the at least one other elongate element to expand the nosepiece member into an expanded state.

16. The delivery device of claim 1, wherein the tip element is inflatable and includes an inflation chamber which, when inflated, expands the tip element such as to open the delivery aperture to an open configuration, optionally the tip element of the nosepiece is configured such that the delivery aperture is normally in a closed configuration and opened to the open configuration on inflation of the tip element, optionally the delivery aperture is substantially closed in the closed configuration, optionally the inflation chamber comprises an annular chamber which surrounds the delivery aperture.

17. The delivery device of claim 1, wherein the delivery aperture has an asymmetric shape when viewed along the longitudinal axis of the nosepiece.

18. The delivery device of claim 17, wherein the delivery aperture has a narrower section adjacent one, the forwardmost, section of the tip element of the nosepiece and a wider section adjacent the other, rearwardmost, section of the tip element of the nosepiece.

19. The delivery device of claim 17, wherein the delivery aperture has a teardrop shape or a triangular shape when viewed along the longitudinal axis of the nosepiece.

20. The delivery device of claim 1, wherein the nosepiece further comprises a base section from which the tip element of the nosepiece extends.

21. The delivery device of claim 20, wherein the tip element of the nosepiece extends substantially axially to the longitudinal axis of the nosepiece.

22. The delivery device of claim 20, wherein the base section of the nosepiece defines a shoulder which is adapted to define a seal with the nare of the nostril and provides means to which the nare of the nostril can be gripped by the subject.

23. The delivery device of claim 1, wherein the ratio of the lengths of the tip element of the nosepiece adjacent forwardmost and rearwardmost sections thereof is less than 2:

1.

24. The delivery device of claim 1, wherein the ratio of the lengths of the tip element adjacent the forwardmost and rearwardmost sections thereof is greater than 2:

1.

25. The delivery device of claim 1, wherein the ratio of the lengths of the tip element adjacent the forwardmost and rearwardmost sections thereof is about 2:

1.

26. The delivery device of claim 1, wherein the delivery aperture comprises a section which is adjacent to a forwardmost section of the tip element of the nosepiece and extends substantially orthogonally to the longitudinal axis of the nosepiece.

27. The delivery device of claim 1, wherein the nozzle is integrally formed with the tip element.

28. The delivery device of claim 1, wherein the nozzle provides for the delivery of a single jet.

29. The delivery device of claim 28, wherein the jet comprises a liquid jet or a powder jet.

30. The delivery device of claim 1, wherein the nozzle provides for the delivery of an aerosol spray.

31. The delivery device of claim 30, wherein the aerosol spray has an asymmetric profile, with the aerosol spray having a greater spray angle in the vertical, sagittal plane than in a plane orthogonal to the vertical, sagittal plane.

32. The delivery device of claim 31, wherein the spray angle in the vertical, sagittal plane is greater than about 35°

.

33. The delivery device of claim 31, wherein the spray angle in the orthogonal plane is not more than about 35°

.

34. The delivery device of claim 31, wherein the spray angle in the sagittal plane is greater than about 40°

.

35. The delivery device of claim 31, wherein the spray angle in the sagittal plane is greater than about 45°

.

36. The delivery device of claim 31, wherein the spray angle in the sagittal plane is greater than about 50°

.

37. The delivery device of claim 31, wherein the spray angle in the orthogonal plane is not more than about 30°

.

38. The delivery device of claim 31, wherein the spray angle in the orthogonal plane is not more than about 25°

.

39. The delivery device of claim 31, wherein the spray angle in the orthogonal plane is not more than about 20°

.

40. The delivery device of claim 31, wherein the spray angle in the orthogonal plane is not more than about 15°

.

41. The delivery device of claim 30, wherein the aerosol spray comprises a liquid spray or a powder spray.

42. The delivery device of claim 1, wherein the nosepiece is configured, when inserted into the nasal cavity, to extend into the nasal valve.

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

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

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

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

45. The delivery device of claim 1, wherein the delivery unit is manually actuatable.

46. The delivery device of claim 1, wherein substance is delivered substantially axially to the longitudinal axis of the nosepiece.

47. The delivery device of claim 1, wherein the length of the tip element of the nosepiece adjacent the forwardmost section thereof is greater than the length of the tip element of the nosepiece adjacent the rearwardmost section thereof.

48. A nosepiece for delivering substance to a nasal cavity of a subject, the nosepiece comprising:

a tip element which includes a delivery aperture from which substance is in use delivered into the nasal cavity, and

the tip element is at least in part tapered so as to be inclined to a longitudinal axis of the nosepiece, with the delivery aperture extending both laterally across the tip element and along a longitudinal extent of the tip element in relation to the longitudinal axis, wherein a length of the tip element of the nosepiece adjacent a forwardmost section thereof is greater than a length of the tip element of the nosepiece adjacent a rearwardmost section thereof.

49. The nosepiece of claim 48, wherein substance is delivered substantially axially to the longitudinal axis of the nosepiece.

50. The nosepiece of claim 48, wherein the length of the tip element of the nosepiece adjacent the forwardmost section thereof is greater than the length of the tip element of the nosepiece adjacent the rearwardmost section thereof.

51. The nosepiece of claim 48, wherein the ratio of the lengths of the tip element of the nosepiece adjacent forwardmost and rearwardmost sections thereof is less than 2:

1.