Intranasal delivery devices and methods of use
The present disclosure describes devices for intranasal drug delivery to targeted regions and sub-regions of a nasal cavity of a subject, including turbinates. The devices may have a housing with a dispensing element, and a positioning or trigger element coupled to the housing that positions the dispensing element within a nasal channel and limits its depth of insertion. The dispensing element may comprise a side opening for dispensing a composition. Devices of the present disclosure may provide a convenient and effective way to deliver compositions intranasally to the targeted regions and sub-regions while limiting off-target delivery.
1 . A device for intranasal delivery to a subject, the device comprising:
(a) a housing defining an insertable portion configured for insertion into a nasal channel of the subject, the insertable portion comprising a distal end, and a proximal end; and
(b) a subject engaging portion coupled to the proximal end of the insertable portion, the subject engaging portion comprises a U shape and is configured to engage a columella region of the subject by simultaneously contacting a downward facing lateral face of the columella region, a leftward facing lateral face of the columella region, and a rightward facing lateral face of the columella region, thereby seating the insertable portion such that the distal end of the insertable portion is positioned within an ejection zone of the nasal channel of the subject, wherein the ejection zone is:
(i) 0 mm to 30 mm superior to a horizontal line that intersects an anterior aspect of an internal nasal valve, and
(ii) 0 mm to 20 mm anterior to an inclined line that intersects an anterior aspect of a middle turbinate and a posterior aspect of a vestibule,
wherein the insertable portion comprises a dispensing element for delivery of a composition to a region or sub-region of the nasal channel of the subject, wherein the dispensing element comprises a side opening.
2 . The device of claim 1 , wherein the device is transitionable from a first configuration to a second configuration, wherein the dispensing element extends from the insertable portion upon transition of the device from the first configuration to the second configuration.
3 . The device of claim 2 , wherein the side opening comprises a length at least about 10% of a length of the dispensing element extended from the insertable portion in the second configuration.
4 . The device of claim 2 , wherein application of pressure by the subject engaging portion to the columella region of the subject is configured to actuate the device.
5 . The device of claim 1 , wherein the dispensing element is extended from the insertable portion, wherein the side opening comprises a length at least about 10% of a length of the dispensing element extended from the insertable portion.
6 . The device of claim 1 , wherein the side opening comprises a width of at least about 10% and at most about 95% of a width of the dispensing element.
7 . The device of claim 1 , wherein the side opening comprises a length from about 2 mm to about 15 mm.
8 . The device of claim 1 , wherein the side opening comprises an opening area of between about 0.2 mm 2 and about 50 mm 2 .
9 . The device of claim 1 , wherein the device is configured to dispense a fluid as a laminar flow.
10 . The device of claim 1 , wherein the housing further comprises a second insertable portion for insertion into a second nasal channel of the subject.
11 . The device of claim 1 , wherein the dispensing element comprises a dispensing channel positioned along a length of the dispensing element, wherein the dispensing channel is positioned off-center along the dispensing element.
12 . The device of claim 1 , wherein the dispensing element comprises a dispensing channel, wherein the dispensing channel is tapered at a distal end of the dispensing channel.
13 . The device of claim 1 , wherein the device is configured to eject the composition from the side opening at a volumetric flow rate of between about 1.5 ml/s and about 20 ml/s.
14 . The device of claim 1 , wherein the region or sub-region of the nasal channel comprises one or more turbinates.
15 . The device of claim 1 , wherein the region or sub-region of the nasal channel is a superior turbinate, the middle turbinate, an inferior turbinate, a middle meatus, or a nasopharynx.