NASAL DELIVERY DEVICES

Abstract

A nasal delivery device for delivering substance to a nasal cavity of a subject comprises: a housing (15); a nosepiece (17) for fitting to a nasal cavity of the subject: a mouthpiece (19) through which the subject in use exhales; and a flexible coupling (20) which couples the mouthpiece to the housing, wherein the flexible coupling provides for asymmetric translation of the mouthpiece relative to the nosepiece.

Claims

1-38. (canceled)

39. A nasal delivery device for delivering substance to a nasal cavity of a subject, the delivery device comprising: a housing; a nosepiece for fitting to a nasal cavity of the subject, the nosepiece having a longitudinal axis; a mouthpiece through which the subject in use exhales, the mouthpiece including a tubular section and having a longitudinal axis; a flexible coupling connecting the mouthpiece to the housing, wherein the flexible coupling comprises an annular coupling member which is attached at a first end to the housing and at a second end to the tubular section of the mouthpiece, wherein the annular coupling member includes a hinge section disposed on a first side of the annular coupling member, proximate the nosepiece and generally opposite a second side of the annular coupling member, about which the mouthpiece is hinged to permit the tubular section of the mouthpiece to move towards or away from the longitudinal axis of the nosepiece when biased towards or away from the nosepiece by application of a biasing force, the first side of the annular coupling member being relatively shorter in length than the second side of the annular coupling member and forming an acute angle between the longitudinal axis of the nosepiece and the longitudinal axis of the mouthpiece; and a substance delivery system configured to deliver the substance through the nosepiece during a period of time when the subject exhales through the mouthpiece; wherein a biasing force required to move the tubular section of the mouthpiece towards the longitudinal axis of the nosepiece by biasing the tubular section of the mouthpiece towards the nosepiece is lower than a biasing force required to move the tubular section of the mouthpiece away from the longitudinal axis of the nosepiece by biasing the tubular section of the mouthpiece away from the nosepiece.

40. The delivery device of claim 39, wherein the nosepiece includes an outlet from which substance is in use delivered to the nasal cavity of the subject, and a seat against which a nare of a nostril of the subject is in use seated to achieve a sealing fit between the nosepiece and the nasal cavity of the subject.

41. The delivery device of claim 39, wherein the annular coupling member has an arcuate, bowed profile on the second side thereof and is configured to stretch when the tubular section of the mouthpiece is biased towards the nosepiece and compress when the tubular section of the mouthpiece is biased away from the nosepiece.

42. The delivery device of claim 39, wherein the longitudinal axis of the mouthpiece is disposed at an angle of between about 45 and about 55 degrees relative to the longitudinal axis of the nosepiece.

43. The delivery device of claim 42, wherein the longitudinal axis of the mouthpiece is disposed at an angle of between about 48 and about 52 degrees relative to the longitudinal axis of the nosepiece.

44. The delivery device of claim 42, wherein the annular coupling member is configured to permit movement of the tubular section of the mouthpiece towards the nosepiece through an angle of between about 7 and about 17 degrees relative to the longitudinal axis of the nosepiece.

45. The delivery device of claim 44, wherein the annular coupling member is configured to permit movement of the tubular section of the mouthpiece towards the nosepiece through an angle of between about 9 and about 15 degrees relative to the longitudinal axis of the nosepiece.

46. The delivery device of claim 44, wherein the annular coupling member is configured to permit movement of the tubular section of the mouthpiece towards the nosepiece through an angle of between about 10 and about 14 degrees relative to the longitudinal axis of the nosepiece.

47. The delivery device of claim 42, wherein the annular coupling member is configured to permit movement of the tubular section of the mouthpiece away from the nosepiece through an angle of between about 4 and about 10 degrees relative to the longitudinal axis of the nosepiece.

48. The delivery device of claim 47, wherein the annular coupling member is configured to permit movement of the tubular section of the mouthpiece away from the nosepiece through an angle of between about 5 and about 9 degrees relative to the longitudinal axis of the nosepiece.

49. The delivery device of claim 47, wherein the annular coupling member is configured to permit movement of the tubular section of the mouthpiece away from the nosepiece through an angle of between about 6 and about 8 degrees relative to the longitudinal axis of the nosepiece.

50. The delivery device of claim 39, wherein the annular coupling member is formed of a thermoplastic elastomer (TPE).

51. The delivery device of claim 50, wherein the TPE has a durometer of between about 40 and about 60.

52. The delivery device of claim 51, wherein the TPE has a durometer of between about 45 and about 55.

53. The delivery device of claim 39, wherein the substance delivery system is a substance supply unit which is configured to deliver the substance following manual actuation of the substance supply unit.

54. The delivery device of claim 39, wherein the second side of the annular coupling member forms an obtuse angle relative to the housing.

Description

[0052] Preferred embodiments of the present invention will now be described hereinbelow by way of example only with reference to the accompanying drawings, in which:

[0053] FIG. 1 illustrates a perspective view of a nasal delivery device in accordance with a first embodiment of the present invention;

[0054] FIG. 2 illustrates a vertical sectional view of the delivery device of FIG. 1, with the mouthpiece in the at rest position;

[0055] FIG. 3 illustrates a vertical sectional view of the delivery device of FIG. 1, with the mouthpiece in a position biased upwardly relative to the nosepiece;

[0056] FIG. 4 illustrates a vertical sectional view of the delivery device of FIG. 1, with the mouthpiece in a position biased downwardly relative to the nosepiece;

[0057] FIG. 5 illustrates the results of a study to determine adequacy of fit of the delivery device of FIG. 1, as compared to three comparator devices;

[0058] FIG. 6 illustrates success of subjects in achieving a plurality of steps in fitting the delivery device of FIG. 1; and

[0059] FIG. 7 schematically illustrates the anatomy of the upper respiratory tract of a human subject.

[0060] The delivery device comprises a housing 15, a nosepiece 17 for fitting in a nasal cavity of a subject, a mouthpiece 19 through which the subject in use exhales, a flexible coupling 20 which couples the mouthpiece 19 to the housing 15, and a substance supply unit 21 which is manually actuated to deliver substance to the nasal cavity of the subject.

[0061] The nosepiece 17 includes an outlet 25 from which substance is delivered, a tapered section 27 which in use is located within a nasal cavity of the user and tapers outwardly from the outlet 25, and a seat 29 against which the nare of the nostril is in use seated, in achieving a sealing fit between the nosepiece 17 and the nasal cavity of the user.

[0062] The mouthpiece 19 comprises a tubular section 31, in this embodiment of a rigid or semi-rigid material.

[0063] The flexible coupling 20 is a resilient element which allows for movement of the mouthpiece 19 relative to the nosepiece 17, in this embodiment an asymmetric translation of the mouthpiece 19 relative to the nosepiece 17.

[0064] The present inventors have recognized that a fixed relationship between the mouthpiece 19 and the nosepiece 17 would not allow the delivery device to accommodate sufficient of the possible patient population using a single delivery device, given the variance that exists between patients, particularly in terms of age, gender and ethnicity, and have further recognized that an entirely free and flexible coupling between the mouthpiece 19 and the nosepiece 17, without any constraint, would not be sufficient, in not maintaining a desired relationship between the mouthpiece 19 and the nosepiece 17, which the present inventors have determined to be necessary to achieve a required orientation of the delivery device for optimizing delivery of substance.

[0065] The present inventors have determined that the provision of asymmetric translation of the mouthpiece 19 relative to the nosepiece 17 when the mouthpiece 19 is moved, and specifically in a manner which provides for greater movement in a direction along the axis of the nosepiece 17 than in a direction laterally to the nosepiece 17, provides an arrangement which allows for fitting of a single-sized delivery device in a much greater range of the possible patient population.

[0066] FIG. 5 illustrates the results of a study of 29 subjects to determine adequacy of fit of the delivery device, as compared to three comparator delivery devices (Products A, B and C). Adequate fit is defined as the delivery device fitting the subject and sealing sufficiently in the nose and mouth as to allow use of the delivery device, though may not find the delivery device preferable or comfortable.

[0067] In this study, the asymmetric translation of the mouthpiece 19 relative to the nosepiece 17 provides an arrangement which allowed for fitting of a single-sized delivery device in 28 of 29 subjects.

[0068] FIG. 6 illustrates success of subjects in achieving a plurality of steps in fitting the delivery device.

[0069] In this study, the subjects were required repeatedly to perform the steps of (1) fitting the nosepiece 17 in a nasal cavity, (2) locating the mouthpiece 19 in the mouth, and (3) blowing into the mouthpiece 19.

[0070] In these steps, the following parameters were measured for the first and last sequence of steps: (A) achieving a proper seal at the nosepiece 17, (B) aiming the nosepiece 17 correctly, (C) achieving a proper seal at the mouthpiece 19, (D) blowing into the mouthpiece 19, (E) blowing into the mouthpiece 19 with adequate exhalation force, and (F) performing the sequence of steps in the appropriate order.

[0071] As will be observed, a very high degree of patient compliance is achieved by the delivery device, which improves with use of the delivery device.

[0072] In this embodiment the distal end D of the mouthpiece 19 is configured to move a distance Y at least 1.5 times greater in a direction parallel to the axis of the nosepiece 17 than in a direction X orthogonally to the axis of the nosepiece 17. More preferably, the distal end D of the mouthpiece 19 is configured to move a distance at least 1.75 times or at least 2 times greater in a direction Y parallel to the axis of the nosepiece 17 than in a direction X orthogonally to the axis of the nosepiece 17.

[0073] In this embodiment the flexible coupling 20 comprises an annular coupling member 41 which is attached in one part to the housing 15 and another part to the tubular section 31 of the mouthpiece 19, such that exhalation through the mouthpiece 19 delivers an air flow into the housing 15.

[0074] In this embodiment the coupling member 41 is configured to provide a hinge section 43, here, to one, upper side thereof, proximate the nosepiece 17, about which the mouthpiece 19 is preferentially hinged when biased upwardly or downwardly by the application of a biasing force F.

[0075] In this embodiment the coupling member 41 has a shorter dimension to the one, upper side, thereby ensuring that the mouthpiece 19 is hinged about the one, upper side, and a progressively-increasing dimension to the other, lower side, distal the nosepiece 17.

[0076] In this embodiment the coupling member 41 has an arcuate, bowed profile 45 which becomes larger towards the other lower side, and allows for stretching in the event of the mouthpiece 19 being biased upwardly, as illustrated in FIG. 3, and compression in the event of the mouthpiece 19 being biased downwardly, as illustrated in FIG. 4.

[0077] In this embodiment the profile section 45 is bowed outwardly, whereby the biasing force required to bias the mouthpiece 19 upwardly is less than the biasing force required to bias the mouthpiece 19 downwardly. Again, for reasons of optimizing fitting and orientation of the delivery device, the present inventors have recognized that this is achieved by requiring the mouthpiece 19 to be biased upwardly from a lower position. Thus, the delivery device is configured to facilitate operation by providing that raising the mouthpiece 19 is easier than lowering the mouthpiece 19, and this is further promoted by configuring the mouthpiece 19 such that the position of the mouthpiece 19 is lower than required for a majority of the patient population.

[0078] In this embodiment the coupling member 41 is configured to provide the axis of the mouthpiece 19 at an angle of about 50 degrees relative to the axis of the nosepiece 17, and allow for the mouthpiece 19 to be moved upwardly through an angle of about 12 degrees to enclose an angle of about 38 degrees relative to the axis of the nosepiece 17 and downwardly through an angle of about 7 degrees to enclose an angle of about 57 degrees relative to the axis of the nosepiece 17.

[0079] In an alternative embodiment the coupling member 41, instead or in addition to having a bowed profile section 45, can be formed of graded material, such that the material of the coupling member 41 is less resilient at the one, upper side than the other, lower side.

[0080] In this embodiment the coupling member 41 is formed of a thermoplastic elastomer (TPE), preferably having a durometer of 50.

[0081] Finally, it will be understood that the present invention has been described in its preferred embodiments and can be modified in many different ways without departing from the scope of the invention as defined by the appended claims.