[0001] This application claims the benefit of GB Application No. 2201107.6, filed 28 January 2022, the disclosure of which is incorporated by reference herein in its entirety.

Technical Field

[0002] The present disclosure relates to a device for delivery of a compound to at least one specific region of the nasal cavity. More specifically, the present disclosure relates to a nasal pressurised metered dose delivery device for delivering medicaments (also known as active pharmaceutical ingredients, or APIs) to one or more of the olfactory region, the turbinates region and the nasopharynx of the nasal cavity.

Background

[0003] Traditional aqueous nasal sprays typically deposit drugs close to the nasal valve, not deep in the nasal cavity where locally acting drugs may be required.

[0004] Examples of specific regions in the nasal cavity that may benefit from local, targeted application of medicaments are the olfactory region, the turbinates (superior, middle and / or inferior) and the nasopharynx.

[0005] Starting with the olfactory region, there are many conditions and disorders of the central nervous system (CNS) that require delivery of drugs to the brain. Treatment of diseases such as Alzheimer’s can benefit significantly from the use of drugs introduced to the tissues of the brain.

[0006] Unfortunately, delivery of drugs to the brain is problematic. The brain is a highly sensitive and well protected organ, and techniques for drug delivery can therefore be invasive, requiring a high degree of medical intervention, as well as significant inconvenience and discomfort to the patient. Further, the blood-brain barrier (BBB) tends to impede the transport of molecules to the brain.

[0007] These technical challenges have resulted in promising medicaments being discarded due to the difficulty in delivering them to the brain, and consequent under funding of this important area of medicine.

[0008] One area where the brain is in contact with the exterior of the body is in the nasal cavity. The olfactory nerve extends from the brain into the nasal cavity where direct contact is made between these nerves and the cavity, penetrating the mucosal lining. Millions of neurons are present at this location, facilitating the subject's sense of smell. It has been suggested that these neurons may offer a route to deliver medicaments from the nasal cavity to the brain (the ‘nose-to-brain ^! or ^! N2B ^! route). Importantly, use of this route would bypass the otherwise prohibitive blood-brain barrier. Nose to brain transport is therefore seen as an important potential route to deliver important drugs to the CNS.

[0009] Although the olfactory nerve endings offer this potential, they are still not easily accessed. They are positioned well into, and on the superior surface of, the nasal cavity. The region is situated in an area of complex and narrow geometry. Therefore, there are challenges in designing a mechanism to deliver medicaments to this surface.

[0010] As well as delivery to the olfactory region, it can also be desirable to introduce medicaments into the other, deeper, regions of the nasal cavity.

[0011] The nasopharynx is the uppermost part of the throat, lying above the oral cavity, extending after the choanae in the nasal cavities. It will be noted that the nasopharynx is described herein as part of the nasal cavity.

[0012] Targeted nasopharynx drug delivery has potential for therapies for both cancer and viruses located in this region e.g., the Covid-19 virus (SARS-CoV-2).

[0013] It is also desirable to introduce medicaments to the turbinates regions of the nasal cavity.

[0014] Applicant’s co-pending application PCT/US2021/043424 describes a nasal delivery device for delivery of a medicament to the olfactory, turbinates and nasopharyngeal regions. The device disclosed therein relies on increasing the delivery force of the medicament in order to project further into the nasal cavity towards the desired location.

[0015] It is an aim of the present disclosure to seek an alternative means of delivering the medicament to the various above-mentioned regions of the nasal cavity.

[0016] EP 0 692 273 discloses a nebulizing catheter arrangement in which an endotracheal tube is used to feed a catheter into a patient’s lungs. Liquid medication is mixed with gas to aerosolise and propel the medicament to the lungs. In this situation, the patient is intubated and a ventilator is attached to the endotracheal tube.

[0017] US 5,062,423 discloses a device for delivery of an aerosolised drug for treatment of lung conditions such as asthma to an animal. A canister containing a medicament and a propellant is provided with a metering valve for dispensing a dose of medicament. A nasai tube is inserted into the nostril in order to deliver the medicament to the nasal-pharyngeal cavity of the animal whereby it has a better chance of reaching the animal’s lungs.

[0018] US 2006/276,552 discloses a nasal catheter intended to be placed through the patient’s nostrils and extend through the nasal cavity to the nasopharyngeal region.

[0019] CN106994205A discloses a medical device for the nasopharynx having an atomiser at one end.

[0020] CN111388848A discloses a drug delivery device and method for delivery to the nasopharynx. The device comprises a C-shaped nozzle for insertion into the nasal cavity.

Summary of Invention

[0021] It is an aim of the present disclosure to provide an improved apparatus for introduction of a medicament to a specific region of the nasal cavity.

[0022] According to a first aspect of the disclosure there is provided a device for delivery of a medicament to a target region, the target region being at least one of the olfactory region, the turbinates region and the nasopharynx of a nasal cavity, the device including a canister that includes a container containing a pressurised propellant and the medicament; and a metering valve configured to release a predetermined amount of the pressurised propellant and the medicament. The device further includes an actuator including a valve block receiving the metering valve, the valve block defining a chamber for passage of propellant and medicament expelled from the canister; and a delivery tube for insertion into a user’s nostril. The delivery tube includes an elongate, flexible fluid conduit in fluid communication with the valve block, the flexible fluid conduit defining at least one delivery opening for delivery of the medicament to the inside of a human or animal nasal cavity in use. The delivery tube further includes a positioning element attached to the flexible fluid conduit, where the positioning element is configured to cause a deformation in the flexible fluid conduit to direct the delivery opening at the target region.

[0023] Advantageously, the provision of the combination of a flexible tube and positioning element allows the delivery opening to be positioned very accurately within the nasal cavity to target specific areas.

[0024] In one embodiment, the positioning element is a mass element positioned distal to the valve block, configured to produce a curvature in the delivery tube in use by virtue of its weight acting on the delivery tube. Preferably the mass element is at least partially constructed from a material having a higher density than the material from which the delivery tube is constructed. Alternatively, the mass element may be a region of increased volume of material having a similar, or the same density as the delivery tube material. For example, a region of increased cross-sectional area.

[0025] Instead, or in addition, the positioning element is a bulbous element extending outwardly from the delivery tube, configured to guide and thereby deform the delivery tube within the nasal cavity. The bulbous element guides the delivery tube by contacting an internal surface of the user’s nasal cavity. The positioning element may be a combined mass and bulbous element. By “bulbous element” we mean that the element has an outer perimeter having an area greater than the bulk of the delivery tube and preferably at least twice the diameter (or equivalent diameter) of the delivery tube.

[0026] Preferably the positioning element is annular in shape, surrounding the delivery tube.

[0027] The delivery tube and the positioning element may be unitary.

[0028] The delivery tube has a point where it emerges from, or joins the actuator, and a free end. The distance between these points is referred to as the ‘free length’. Preferably the positioning element is positioned at least partially in the 50% of the free length adjacent the free end. More preferably, the positioning element is positioned at least partially in the 20% of the free length adjacent the free end. Even more preferably, the positioning element is positioned at least partially in the 10% of the free length adjacent the free end.

[0029] The positioning element may be configured to apply a deflection force between two spaced apart positions on the delivery tube to thereby deform the delivery tube. The deflection force may be, e.g., tensile or compressive. The positioning element may provide this force by provision of an elastic deformation element to urge the tube into a curved shape.

[0030] Preferably the delivery tube and the positioning element are unitary.

[0031] Preferably the actuator includes a nosepiece base extending therefrom, where the delivery tube extends from the nosepiece base. For example, the delivery tube may extend from the valve block, through the nosepiece base.

[0032] Preferably the nosepiece base has a higher stiffness than a portion of the delivery tube extending from the nosepiece base such that the nosepiece base does not deform in use. [0033] Preferably the actuator has a primary axis, and where the nosepiece base has a flow axis extending at an angle to the primary axis, where the angle is greater than 15 degrees and less than 75 degrees.

[0034] Preferably the delivery tube extends into the nosepiece base towards the valve block.

[0035] Preferably the delivery tube has a length of between 30 and 120 mm from the actuator.

[0036] Preferably the elongate, flexible fluid conduit includes a lumen having a cross sectional area which is between 0.3 and 10 mm ² . The lumen may be of variable cross sectional area, tapering from one size to another, inwardly or outwardly.

[0037] Preferably the elongate, flexible fluid conduit is constructed from a material having a Youngs modulus below 10GPa, preferably between 0.01 and 10 GPa. Preferably, the bending stiffness of the delivery tube is less than 0.1N/mm, and more preferably between 0.005 and 0.1 N/mm at the free end.

[0038] Preferably the material is PEEK.

[0039] Preferably the at least one delivery opening includes an opening in an axial end of the delivery tube.

[0040] Instead, or as well, the at least one delivery opening includes an opening in a sidewall of the delivery tube.

[0041] The device may include one or more positioning elements as required.

[0042] The device may include one delivery opening or multiple adjacent delivery openings.

[0043] According to a second aspect there is provided a method of delivery of a medicament to at least one of the olfactory region, the turbinates region and the nasopharynx of a nasal cavity. The method includes providing a canister that includes a container containing a pressurised propellant and the medicament, and a metering valve configured to release a predetermined amount of the pressurised propellant and the medicament. The method further includes providing an actuator that includes a valve block receiving the metering valve, the valve block defining a chamber for passage of propellant and medicament expelled from the canister. The method further includes providing a delivery tube for insertion into a user’s nostril, the delivery tube includes an elongate, flexible fluid conduit in fluid communication with the valve block, the flexible fluid conduit defining a delivery opening where the delivery tube includes a positioning element attached to the flexible fluid conduit. The method further includes inserting the elongate, flexible fluid conduit into a nasal cavity of a human or animal such that the positioning element produces curvature in the flexible fluid conduit; and actuating the metering valve to deliver the medicament to the inside of the nasal cavity.

[0044] According to a third aspect there is provided a device for delivery of a medicament to at least one of the olfactory region, the turbinates region and the nasopharynx of a nasal cavity. The device includes a canister including a container containing a pressurised propellant and the medicament; and a metering valve configured to release a predetermined amount of the pressurised propellant and the medicament. The device further includes an actuator including a valve block receiving the metering valve, the valve block defining a chamber for passage of propellant and medicament expelled from the canister; and a delivery tube for insertion into a user’s nostril. The delivery tube includes an elongate, flexible fluid conduit in fluid communication with the valve block, the flexible fluid conduit defining at least one delivery opening for delivery of the medicament to the inside of a human or animal nasal cavity in use. The delivery tube includes an elbow portion having an angle of between 20 and 160 degrees to the delivery tube to direct the delivery opening towards a targeted area in use.

[0045] Preferably the actuator includes a nosepiece base extending therefrom, where the delivery tube extends from the nosepiece base.

[0046] Preferably the nosepiece base has a higher stiffness than the delivery tube such that the nosepiece base does not deform in use.

[0047] Preferably the actuator has a primary axis, and where the nosepiece base has a flow axis extending at an angle to the primary axis, where the angle is greater than 15 degrees and less than 75 degrees.

[0048] Preferably the delivery tube extends into the nosepiece base towards the valve block.

[0049] Preferably the delivery tube has a length of between 30 and 120 mm from the actuator.

[0050] Preferably the elongate, flexible fluid conduit includes a lumen having a cross sectional area which is between 0.3 and 10 mm ² .

[0051] Preferably the elongate, flexible fluid conduit is constructed from a material having a Youngs modulus below 10GPa, preferably between 0.01 and 10 GPa.

[0052] Preferably the material is PEEK. [0053] According to a fourth aspect there is provided a method of deiivery of a medicament to a target region, the target region being at least one of the olfactory region, the turbinates region and the nasopharynx of a nasal cavity. The method includes providing a canister that includes a container containing a pressurised propellant and the medicament; and a metering valve configured to release a predetermined amount of the pressurised propellant and the medicament. The method further includes providing an actuator that includes a valve block receiving the metering valve, the valve block defining a chamber for passage of propellant and medicament expelled from the canister. The method further includes providing a delivery tube for insertion into a user’s nostril, the delivery tube including an elongate, flexible fluid conduit in fluid communication with the valve block, the flexible fluid conduit defining a delivery opening where the delivery tube includes an elbow portion having an angle of between 20 and 160 degrees to the delivery tube to direct the delivery opening towards the target region in use. The method further includes inserting the elongate, flexible fluid conduit into a nasal cavity of a human or animal such that the positioning element produces a curvature in the flexible fluid conduit; and actuating the metering valve to deliver the medicament to the inside of the nasal cavity.

[0054] All headings provided herein are for the convenience of the reader and should not be used to limit the meaning of any text that follows the heading, unless so specified.

[0055] The terms “comprises” and variations thereof do not have a limiting meaning where these terms appear in the description and claims. Such terms will be understood to imply the inclusion of a stated step or element or group of steps or elements but not the exclusion of any other step or element or group of steps or elements.

[0056] The words “preferred” and “preferably” refer to embodiments of the disclosure that may afford certain benefits, under certain circumstances; however, other embodiments may also be preferred, under the same or other circumstances. Furthermore, the recitation of one or more preferred embodiments does not imply that other embodiments are not useful, and is not intended to exclude other embodiments from the scope of the disclosure.

[0057] In this application, terms such as “a,” “an,” and “the” are not intended to refer to only a singular entity, but include the general class of which a specific example may be used for illustration. The terms “a,” “an,” and “the” are used interchangeably with the term “at least one.” The phrases “at least one of” and “comprises at least one of’ followed by a list refers to any one of the items in the list and any combination of two or more items in the list. [0058] As used herein, the term “or” is generally employed in its usual sense including “and/or” unless the content clearly dictates otherwise.

[0059] The term “and/or” means one or all of the listed elements or a combination of any two or more of the listed elements.

[0060] As used herein in connection with a measured quantity, the term “about” refers to that variation in the measured quantity as would be expected by the skilled artisan making the measurement and exercising a level of care commensurate with the objective of the measurement and the precision of the measuring equipment used. Herein, “up to” a number (e.g., up to 50) includes the number (e.g., 50).

[0061] Also herein, the recitations of numerical ranges by endpoints include all numbers subsumed within that range as well as the endpoints (e.g., 1 to 5 includes 1 , 1.5, 2, 2.75, 3, 3.80, 4, 5, etc.).

[0062] These and other aspects of the present disclosure will be apparent from the detailed description below. In no event, however, should the above summaries be construed as limitations on the claimed subject matter, which subject matter is defined solely by the attached claims, as may be amended during prosecution.

Brief Description of Drawings

[0063] Throughout the specification, reference is made to the appended drawings, where like reference numerals designate like elements, and wherein:

FIGURE 1 is a side section view of a first device in accordance with the present disclosure;

FIGURE 2 is a side section view of the device of Figure 1 in-use in a user’s nasal cavity;

FIGURE 3 is a side section view of a second device in accordance with the present disclosure in-use in a user’s nasal cavity;

FIGURE 4 is a side section view of a third device in accordance with the present disclosure in-use in a user’s nasal cavity;

FIGURE 5 is a side section view of a fourth device in accordance with the present disclosure in-use in a user’s nasal cavity;

FIGURE 6 is a side section view of a fifth device in accordance with the present disclosure in- use in a user’s nasal cavity; FIGURE 7 is a side section view of a sixth device in accordance with the present disclosure in-use in a users nasal cavity;

FIGURE 8 is a side section view of a seventh device in accordance with the present disclosure in-use in a users nasal cavity; and,

FIGURE 9 is a side section view of an eighth device in accordance with the present disclosure in-use in a user's nasal cavity.

Detailed description

[0064] In Figure 2 onwards there is shown a cross-section through a human head. The crosssection shows the nose 10; nostril 12; nasal cavity 13 including nasal vestibule 14, olfactory region 16, superior turbinate 18, middle turbinate 20, the inferior turbinate 22; and the nasopharynx 24, leading to the pharynx 26.

[0065] The following embodiments are described as pressurised metered delivery devices (pMDDs). Such devices may also be referred to as pMDIs (pressurised metered dose inhalers) in the art. It will be noted that although the term “inhaler” is used in this context to describe the type of device, operation of the device does not necessarily require the act of inhalation and therefore we have used the term pMDD instead.

Description of the first embodiment

Configuration of the first embodiment

[0066] Referring to Figure 1 , a device 100 according to one or more embodiments of the disclosure in the form of a nasal pMDI is shown. The device 100 can be configured to deliver a medicament to a target region such as at least one of the olfactory region 16, the turbinates region 18, 20, 22, or the nasopharynx 24 of the nasal cavity 13. The device 100 includes a valved canister 102 and an actuator 104.

[0067] The canister 102 includes a container 106 defining a base 108. At the opposite end of the base 108 there is provided a metering valve 110. The valve 110 is sealed to the container 106 via a crimp 112. The valve 110 includes a valve stem 114 which is resiliently moveable towards the container 106. Upon depression of the valve stem 114 towards the container 106, the metering valve 110 is configured to release a predetermined (metered) amount or volume of container fluid content from a valve orifice. Such valves are well known in the art. [0068] The canister 102 is primarily constructed from a metal material (aluminium in this embodiment), although parts of the valve 110 are constructed from plastics materials, as is known in the art. Various coatings can be present on the internal surface of the canister 102 as known in the art.

[0069] The container 106 contains a mixture of a propellant and a medicament formulation.

[0070] The actuator 104 includes a housing 116, a valve block 118 and a delivery arrangement 120.

[0071] The housing 116 includes a generally cylindrical canister-receiving portion 122 having an open end 124 and a closed end or base 126.

[0072] Projecting radially outwardly from the cylindrical portion 122 and angled from the base 126 upwardly in the general direction of the open end 124 (i.e. , projecting both radially and axially) is a nosepiece base 152. The nosepiece base 152 has a first end 134 in communication with the cylindrical portion 122 and a second, free end 136.

[0073] The valve block 118 is a unitary body defining an inlet 138 defining a valve stem receiving recess 140 having a shoulder 142. The valve block 118 can define an axial flow channel or chamber 144 for passage of propellant and medicament expelled from the canister 102. The recess 140 is in communication with the axial flow channel or chamber 144. Adjacent the flow channel 144 and in communication therewith, extending to a sidewall of the valve block 118 there is provided an exit opening 148.

[0074] The delivery arrangement 120 includes the nosepiece base 152 and a delivery tube 154.

[0075] The nosepiece base 152 is elongate having an end portion 153 that is frustoconical in shape tapering from a wider first end 166 to a narrower second end 168. The nosepiece base 152 defines a through bore or lumen 170 defining a delivery tube opening 176 at the second end 168. The through bore 170 is in fluid communication with the exit opening 148 of the valve block 118. The nosepiece base 152 can have a flow axis that extends along the through bore 170. The through bore or lumen 170 can have any suitable cross- sectional area. In one or more embodiments, the through bore or lumen 170 can have a cross section area that is between 0.1 and 10 mm ² . In one or more embodiments, the actuator has a primary axis along the flow channel or chamber 144, where the flow axis of the nosepiece base 152 extends at an angle to the primary axis of the actuator. In one or more embodiments, the angle between the flow axis and the primary axis is greater than 15 degrees and less than 75 degrees.

[0076] Referring specifically to Figure 2, the device 100 includes a delivery tube 154 for insertion into a user’s nostril 12. The delivery tube 154 is an elongate, flexible fluid conduit that is in fluid communication with the valve block 118. Further, the delivery tube 154 can include a constant cross section and have a through bore 178. The delivery tube 154 has an entry inlet 180 and a delivery outlet or opening 182 for delivery of the medicament to the inside of a human or animal nasal cavity 13. Further, the delivery tube 154 is constructed from a flexible, elastically deformable material, i.e., the Young’s modulus of the material is typically between 0.01 GPa and 10 GPa. Exemplary materials include, e.g., PEEK (Polyether ether ketone) having a Young’s modulus of 3.6GPa. In one or more embodiments, the nosepiece base 152 has a higher stiffness than the delivery tube 154 such that the nosepiece based does not deform in use.

[0077] The delivery tube 154 can also include a positioning element attached to the delivery tube (i.e., flexible fluid conduit) that is configured to cause a deformation in the tube to direct the delivery outlet or opening 182 at the target region. For example, proximate a free end 186 (i.e., proximate the delivery outlet 182) of the delivery tube 154 there is provided a positioning element that includes a mass element 184. The mass element 184 is positioned distal to the valve block 118 and is configured to produce a curvature in the delivery tube 154 in use by virtue of its weight acting on the deliver tube. The mass element 184 is attached to the delivery tube 154 and due to its location proximate the delivery outlet 182, and the fact that the inlet 180 end of the delivery tube is held in the nosepiece base 152, it elastically deforms the delivery tube to form a curved shape. The delivery tube 154 effectively forms a cantilevered beam having a built-in end.

[0078] The mass element 184 in this embodiment is an annular component surrounding the tube 154 and can be constructed from a soft but relatively dense elastomeric material such as rubber. In one or more embodiments, the mass element 184 is at least partially constructed from a material having a higher density than the material from which the delivery tube 154 is constructed.

[0079] By being “proximate the end” we mean that the mass element 184 is at least partially located within 10% of the free end 186 of the delivery tube 154. For example, if the delivery tube 154 is 10 cm long, at least some of the mass element 184 is located with 1 cm of the free end 186 of the delivery tube. Use

[0080] In use, the end of the delivery tube 154 is fed into the user’s nostril 12. The tube 154 continues to be fed into the nasal cavity 13 by bringing the nosepiece base 152 into contact, and engagement with the nostril 12. In this position (shown in Figure 2), the mass element 184 causes a downwardly concave (upwardly convex) curvature of the tube 154 such that the delivery outlet 182 is directed towards the user’s nasopharynx 24.

[0081] Thus, when the pMDI 100 is activated by depressing the base 108 of the canister 102 against the actuator 104, a bolus of medicament is released through the flow channel 144, into the exit opening 148 to the through bore 178 of the tube 154 and to the delivery outlet 182. There it exits to the nasopharynx 24.

Description of the second embodiment

[0082] Referring to Figure 3, a second embodiment of a device 200 is shown. The device 200 is similar to the device 100 with similar features numbered 200 or greater. In this embodiment a delivery tube 254 of the device 200 is shorter than delivery tube 154, having an inlet 280 and delivery outlet or opening 282 joined by a through bore 278. A positioning element that is a bulbous element 284 is positioned proximate the outlet 282. The bulbous element 284 has a cross-section greater than that of the tube 254. As well as adding mass to a free end 286 of the tube 254 to curve it downwardly into the nasal cavity 13, the bulbous element 284 positions the end of the tube 254 in the nasal cavity by bearing against one or more sidewalls of the nasal cavity. This ensures that the outlet 282 is directed towards the olfactory region 16. In one or more embodiments, the bulbous element 284 is configured to guide and thereby deform the delivery tube 254 within the nasal cavity 13.

Description of the third embodiment

[0083] Referring to Figure 4, a third embodiment of a device 300 is shown. The device 300 is similar to the device 100 with similar features numbered 300 or greater. In this embodiment a free end 386 of a delivery tube 354 is closed, and instead a delivery outlet or opening 382 is formed from a plurality of radially extending openings 383 in fluid communication with a through bore 378. A positioning element that is a bulbous element 384 is positioned proximate the outlet 382. The bulbous element 384 has a cross-section greater than that of the tube 354. As well as adding mass to the end 386 of the tube 354 to curve it downwardly into the nasal cavity 13, the bulbous element 384 positions the end of the tube 354 in the nasal cavity by bearing against one or more sidewalls of the nasal cavity. This ensures that the outlet 382 Is directed towards the olfactory region 16, i.e., that the tube 354 is substantially parallel to the upper surface of the nasal cavity 13.

[0084] Upon activation of the pMDI device 300, the medicament exits the tube 354 via the openings 383 to form a spray, depositing the medicament evenly over the olfactory region 16.

Description of the fourth embodiment

[0085] Referring to Figure 5, a fourth embodiment of a device 400 is shown. The device 400 is similar to the device 100 with similar features numbered 400 or greater. In this embodiment a positioning element that is a mass element 484 is positioned midway along a tube 454. The mass element 484 in this embodiment is an annular component surrounding the tube 454, constructed from a soft elastomeric material such as rubber.

[0086] The mass element 484 is dimensioned to keep the tube 454 away from the superior and inferior internal walls of the nasal cavity 13. In this embodiment, the medicament is delivered via delivery outlet or opening 482, although it will be understood that it could be delivered via one or more spray orifices in the wall of the tube per the third embodiment.

Description of the fifth embodiment

[0087] Referring to Figure 6, a fifth embodiment of a device 500 is shown. The device 500 is similar to the device 100 with similar features numbered 500 or greater. In this embodiment a positioning element that is a mass element 584 is positioned at a free end 586 of a shorter tube 554, which only extends as far as the turbinates region 20 of the nasal cavity 13 where it terminated. The mass element 584 in this embodiment is an annular component surrounding the tube 554, constructed from a soft elastomeric material such as rubber.

[0088] In this embodiment the free end 586 of the delivery tube 554 is closed, and instead a delivery outlet or opening 582 is formed from a plurality of radially extending openings 583 in fluid communication with a through bore 578.

Description of the sixth embodiment

[0089] Referring to Figure 7, a sixth embodiment of a device 600 is shown. The device 600 is similar to the device 100 with similar features numbered 600 or greater. In this embodiment a tube 654 has an end section 685 that is connected to the tube via a kink or elbow 687 such that a delivery outlet or opening 682 is directed towards the region of interest™-in this case the olfactory region 16.

Description of the seventh embodiment

[0090] Referring to Figure 8, a seventh embodiment of a device 700 is shown. The device 700 is similar to the device 100 with similar features numbered 700 or greater. In this embodiment a tube 754 has no mass or bulbous element. Instead, the tube 754 is deformed via a positioning element that is a tension member 790 that connects two spaced-apart positions 702, 704 on the tube 754.

[0091] The tension member 790 is constructed from a flexible, resilient material having a resting (unstressed) length less than that of the tube 754. in this way, the tension member 790 tends to puli the tube 754 into a curved shape as shown in Figure 8. In one or more embodiments, the tension member 790 is configured to apply a deflection force between the two spaced-part positions 702, 704 on the delivery tube 754 to thereby deform the delivery tube. In one or more embodiments, the tension member 790 is an elastically deformable element configured to urge the delivery tube 754 into a curved shape.

[0092] The length and material of the tension member 790 is selected such that the tube 754 can easily be straightened by hand for insertion into the nose 10, at which point it will adopt its curved form within the nasal cavity 13. It will be noted that in this embodiment, a delivery outlet or opening 782 of the tube 754 is directed towards the nasopharynx 24.

Description of the eighth embodiment

[0093] Referring to Figure 9, an eighth embodiment of a device 800 is shown. The device 800 is similar to the device 100 with similar features numbered 800 or greater, in this embodiment a tube 854 has no mass or bulbous element. Instead, the tube 854 is deformed via a shape memory member 890 that is connected to the upper surface of the tube 854.

[0094] The member 890 is constructed from a flexible, resilient material having a resting (unstressed) shape being curved per Figure 8. In this way, the member 890 tends to form the tube 854 into a curved shape as shown in Figure 8.

[0095] The material of the member 890 is selected such that the tube 854 can easily be straightened by hand for insertion into the nose 10, at which point it will adopt its curved form within the nasal cavity 13. It will be noted that in this embodiment, a delivery outlet or opening 882 of the tube 854 is directed towards the nasopharynx 24. Variations

[0096] Although the mass element Is described as a separate component that is attached to the tube, it may alternatively be co-moulded therewith. For example, the mass element may include one or more components that have been overmoulded proximate the end of the tube. Alternatively, the mass element may simply be an area of increased cross section of the tube material.

[0097] The bulbous element may be constructed from the same material as the tube, and may be fluid filled, with a liquid e.g., water, or a gas, e.g., with air.

[0098] In any of the embodiments, the mass element and bulbous element may be combined and / or interchanged. The benefit of the mass element is providing deformation of the tube via application of a force, in the form of weight. The benefit of the bulbous element is positioning of the tube by contact with internal surfaces of the nasal cavity. Therefore, a bulbous mass element may be provided that has both of these benefits.

[0099] The tension applied by the member 790 in Figure 8 is applied by the inherent elasticity of the member. Instead, it may be provided by a mechanism designed to pull the member. In this case, the member 790 would be inextensible.

[0100] Multiple tension members may be provided.

[0101] The delivery tube may be constructed from multiple materials, for example, several lengths of materials having different properties. This may be used to influence the deformed shape of the tube.

[0102] All references and publications cited herein are expressly incorporated herein by reference in their entirety into this disclosure, except to the extent they may directly contradict this disclosure. Illustrative embodiments of this disclosure are discussed, and reference has been made to possible variations within the scope of this disclosure. These and other variations and modifications in the disclosure will be apparent to those skilled in the art without departing from the scope of the disclosure, and it should be understood that this disclosure is not limited to the illustrative embodiments set forth herein. Accordingly, the disclosure is to be limited only by the claims provided below.