Nasal spray guide

Abstract

The nasal spray guide may include a flange defining a lumen configured to receive the distal end of the nasal sprayer, a shoulder surface extending radially outward from the flange and angled with respect to the lumen, and a cap defining a cavity and configured to engage the shoulder such that the cavity is substantially aligned with the lumen. In some variations, a method of using the nasal spray guide includes positioning at least a portion of the nasal sprayer within the lumen such that the distal portion of the nasal sprayer is exposed, inserting the distal portion of the nasal sprayer into the user's nostril until the shoulder of the nasal spray guide seats against the user's nasal surface, and actuating the nasal sprayer while the shoulder of the nasal spray guide is seated.

Description

Technical Field

[0001] (Cross - Reference to Related Applications) This application claims the priority of, and is a continuation of, U.S. Patent Application No. 17 / 829,286, filed on May 31, 2022, the entire content of which is incorporated herein by reference. The present invention generally relates to the field of nasal sprayers.

Background Art

[0002] Many substances, such as fluid medications, can be administered into the nostrils using a nasal sprayer. A typical nasal sprayer includes a nasal sprayer tip and a pump coupled to a container that holds the fluid to be administered through the nasal sprayer. The user can insert the nasal sprayer tip into the user's nostril and then operate the pump to supply fluid from the container to the nasal sprayer tip, and the nasal sprayer tip administers a fine mist of fluid into the nostril.

[0003] It is often important that the fluid be administered to a certain intended target tissue (e.g., an area rich in blood vessels to improve absorption). The location of drug administration can be affected, for example, by the spray pattern, droplet size distribution, and the specific plume shape of the fluid dispensed by the nasal sprayer tip, and / or by the user's actions in positioning the nasal sprayer when operating the pump. Although device manufacturers can control the spray characteristics to some extent through design considerations, they can hardly prevent inappropriate operation of the device by the user. For example, when using a conventional nasal sprayer, the user may insert the nasal sprayer tip too deeply into the nostril, and as a result, the administered fluid may be administered to the back of the throat (e.g., dripping into the nasal cavity) instead of the desired nasal tissue. As another example, some drugs are intended to be administered to one side (e.g., the outer side) of the nostril, but the user may angle the nasal sprayer tip inaccurately and / or inconsistently, which can lead to inaccurate drug administration.

[0004] Accordingly, there is a need for additional systems and methods for guiding the administration of substances via a nasal sprayer.

SUMMARY OF THE INVENTION

[0005] A nasal spray guide may be utilized in conjunction with a nasal sprayer to assist in the administration of fluid from the nasal sprayer. Generally, in some variations, the nasal spray guide may include a flange defining a lumen configured to receive the nasal sprayer tip, and a shoulder extending radially outward from the flange, the shoulder including a shoulder surface angled with respect to the lumen. In some variations, the inner diameter of the lumen may vary and / or may include one or more radially inward protrusions.

[0006] In some variations, the shoulder surface may be angled obliquely with respect to the lumen at an angle between about 60° - 80° (e.g., about 75°). The shoulder surface may surround at least a portion of the lumen and, in some variations, may substantially surround the lumen. In some variations, the shoulder surface may be substantially planar and elliptical, and the shoulder surface may have an out-of-plane curvature (e.g., concave, convex) and / or shape (e.g., circular, rectangular, etc.) to any suitable degree.

[0007] In some variations, the nasal spray guide includes a lid, which may be configured to engage the shoulder such that the lid defines a cavity and the cavity is substantially aligned with the lumen. The lid may cover and / or surround the nasal sprayer tip within the cavity, for example, during the administration of fluid from the nasal sprayer. In some variations, the lid may be separate and detached from the flange and shoulder of the nasal spray guide, while in some variations, the lid may be coupled to the flange and / or shoulder of the nasal spray guide. For example, in some variations, the lid may be coupled to the flange, shoulder, or both by a tether (e.g., a flexible member).

[0008] Furthermore, in some variations, the nasal spray guide may include an alignment indicator configured to indicate a desired predetermined orientation of the nasal spray guide with a body landmark on the user. The alignment indicator may be disposed, for example, on the shoulder portion (e.g., shoulder surface) and / or the flange portion of the nasal spray guide. The alignment indicator can have any suitable structure (e.g., a molded feature, a surface label, a color-coded material, etc.) and / or convey alignment information in any suitable manner (e.g., a graphic, text, a flange code, etc.). In an exemplary variation, the nasal spray guide may include an alignment indicator in the form of an arrow molded on the shoulder surface, with the shoulder surface angled away from the nasal septum and configured to indicate the side of the shoulder that should be closer to the user's nasal septum.

[0009] Generally, in some variations, a method of assisting in the administration of fluid from a nasal sprayer may include providing a nasal spray guide having a flange defining a lumen and a shoulder extending radially outward from the flange, positioning at least a portion of the nasal sprayer within the lumen such that a distal portion of the nasal sprayer is exposed, inserting the distal portion of the nasal sprayer into the user's nostril until the shoulder of the nasal spray guide seats against the user's nasal surface, and actuating the nasal sprayer while the shoulder of the nasal spray guide is seated against the user's nasal surface. In some variations, the shoulder surface is angled obliquely with respect to the lumen. In some variations, (e.g., when it is desirable to direct fluid toward a target region including the inferior turbinate), the method may include orienting the nasal spray guide such that the shoulder surface is angled away from the user's nasal septum. The nasal spray guide may, in some variations, include an alignment indicator, and orienting the nasal spray guide may include aligning the alignment indicator with a body landmark on the user.

[0010] In some variations, the method may further include removing the nasal nebulizer tip from the user's nostril and covering the nasal nebulizer tip with a lid. The lid may, in some variations, be coupled to the flap and / or shoulder by a tether (e.g., a flexible member) or may be separated independently from the rest of the nasal spray guide.

Brief Description of the Drawings

[0011]

Fig. 1A - 1C

Fig. 1D

Fig. 2A - 2D

Fig. 2E - 2F

Fig. 3

Fig. 4A - 4E

Fig. 5A - 5B

Fig. 6A - 6B

Fig. 7A - 7B

Fig. 8A - 8B

Fig. 9A - 9E

Fig. 10A - 10E

Fig. 11

[0012] Non-limiting examples of various aspects and variations of the present invention are described herein and shown in the accompanying drawings.

[0013] Devices and methods for assisting nasal spray administration using a nasal sprayer are described herein. For example, a nasal spray guide may be coupled to a nasal sprayer and configured to guide and / or acclimate a user to properly position the nasal sprayer against their nose for improved administration through the nasal sprayer.

[0014] In some variations, the nasal spray guide may include a flange defining a lumen configured to receive the nasal sprayer tip of the nasal sprayer, and a shoulder extending radially outward from the flange. The lumen of the nasal spray guide may be sized to allow the distal end of the nasal sprayer tip (e.g., the portion having the nozzle outlet) to extend beyond the flange. This configuration can ensure that the distal end of the nasal sprayer tip (or at least the nozzle outlet of the nasal spray tip) remains exposed, thereby helping to prevent the nasal spray guide from interfering with or otherwise altering the nasal spray plume itself, thereby maintaining the nasal spray distribution inherent to the nasal sprayer. Generally, when a combination of a nasal spray guide and a nasal sprayer is being used, the shoulder surface of the nasal spray guide may be configured to function as a depth limiter that seats against the user's nose and helps prevent over-insertion of the nasal sprayer tip into the nostril. Further, in some variations, the shoulder surface may be angled with respect to the lumen to help guide the positioning of the nasal sprayer tip within the user's nostril at a desired angle or orientation for administering fluid towards a particular desired target tissue region (e.g., may be angled obliquely).

[0015] In some variations, the nasal spray guide may be removably coupled to the nasal sprayer. The nasal spray guide may be removed during use (e.g., for cleaning or sterilizing the nasal spray guide or the tip of the nasal sprayer), or the nasal spray guide may be positioned and held on the nasal sprayer during use of the nasal sprayer. The nasal spray guide may include (or be configured to operate with) a removable cap that covers the exposed portion of the nasal sprayer tip during use. Or, in some variations, the nasal spray guide or a portion thereof may be integrated with the nasal sprayer.

[0016] Exemplary variations of the nasal spray guide 100 are shown in FIGS. 1A-1D. The nasal spray guide 100 can include a flap portion 110 that defines a lumen 112 configured to receive the tip of the nasal sprayer, and a shoulder portion 120 that extends radially outward from the flap portion 110. As shown in FIG. 1B, the shoulder portion 120 can at least partially surround the lumen 112 such that when the tip of the nasal sprayer 10 is inserted into the lumen 112 (as shown in FIG. 1D), the shoulder portion 120 at least partially surrounds the inserted tip 12 of the nasal sprayer.

[0017] The nasal spray guide 100 enables the operation of the nasal sprayer 10 and may be disposed on the nasal sprayer tip 12 of the nasal sprayer 10 in a non - obstructive manner. For example, as shown in FIG. 1D, the flange 110 may be disposed around the nasal sprayer tip 12 and on the nasal sprayer 10. In some variations, the flange 110 can be seated on or adjacent to a pump - actuating surface 14 that is designed to be actuated by the user's finger to operate the nasal sprayer pump of the nasal sprayer 10. In this configuration, the flange 110 can have a sufficient stand - off height such that there is sufficient clearance for the user's finger to fit into the space between the pump - actuating surface 14 and the shoulder 120. For example, at least one side of the flange 110 can have a stand - off height of at least about 0.5 cm, at least about 0.75 cm, at least about 1 cm, at least about 2 cm, at least 2.5 cm, or at least 3 cm, etc. Additionally or alternatively, the diameter of the portion of the flange 110 adjacent to the pump - actuating surface 14 can be sufficiently smaller than the diameter of the pump - actuating surface 14, thereby leaving a sufficient surface area of the pump - actuating surface 14 for the user's finger to operate the pump (e.g., a radial distance of at least about 1.5 cm on both sides of the flange 110 not covered by the nasal spray guide). For example, the outer diameter of the flange 110 adjacent to the pump - actuating surface 14 (e.g., the lower part of the flange 110 as shown in the orientation of FIG. 1D) can be about 0.5 cm - 2 cm, or about 0.75 cm - 1.75 cm, or about 1 cm - 1.5 cm, etc. Exemplary ranges for the dimensions of the flange 110 are provided above, but it should be understood that the flange 110 can have any suitable dimensions depending on, for example, the dimensions of the nasal sprayer for which the nasal spray guide 100 is used and / or the type of user (e.g., an adult with larger fingers, a child with smaller fingers). In some variations, the flange 110 may be provided in a kit as one of various predetermined sizes (e.g., ultra - small, small, medium, large, extra - large, etc.) or size ranges. The predetermined size can correspond to, for example, the size of the nose and / or the size of the nasal sprayer pump.

[0018] Furthermore, the nasal spray guide 100 can be disposed on the nasal sprayer tip 12 of the nasal sprayer 10 and can prevent interfering with the distribution of the fluid sprayed from the nasal sprayer tip 12. For example, as shown in FIG. 1D, the flange 110 may be disposed around the nasal sprayer tip 12, and the heights of the flange 110 and the shoulder 120 may be sized such that the distal end of the nasal sprayer tip 12 (e.g., including at least the nasal spray outlet 16) extends beyond the shoulder 120 in an exposed manner. Since the uncovered nasal spray outlet 16 is not obstructed by the nasal spray guide 100, the nasal sprayer 10 can emit a nasal spray plume that is not changed by the nasal spray guide, thereby maintaining the spray characteristics essentially provided by the design of the nasal sprayer 10.

[0019] The flange 110 can function to attach the nasal spray guide to the nasal sprayer and / or can function as a standoff that helps to determine the axial position of the nasal spray guide along the nasal sprayer tip and / or the allowable insertion depth of the nasal sprayer tip. For example, the height of the flange 110 (e.g., in combination with the thickness of the shoulder 120) can affect the position of the shoulder 120 relative to the nasal sprayer tip and thus the depth to which the nasal sprayer tip can be inserted into the user's nostril.

[0020] The flange 110 may have any suitable shape. For example, the nasal spray guide shown in FIG. 1A includes a substantially cylindrical flange 110. However, in other variations, the nasal spray guide can have any suitable cross-section, such as elliptical, triangular, square, rectangular, pentagonal, hexagonal, heptagonal, octagonal, or any suitable number of sides. In some variations, the flange 110 may have a substantially constant cross-section (e.g., a prism or cylinder having any suitable cross-section) along its length. In other variations, the flange 110 can have various cross-sections along its length. For example, the flange 110 may be tapered (e.g., frustoconical) as shown in FIGS. 2B-2D.

[0021] Furthermore, the inner cavity 112 defined in the flange portion 110 can have any suitable shape, such as having a cross-section that is circular, elliptical, or the like. Additionally, or alternatively, similar to the flange portion 110, the inner cavity 112 can have a substantially constant cross-section (e.g., as shown in FIG. 1A) along its length passing from one end of the flange portion 110 to the opposite end of the flange portion 110, or a cross-section that varies along its length. For example, the inner cavity 112 can have a tapered or frustoconical shape (e.g., as shown in FIGS. 2A and 2B), such that the cross-section varies. As another example, as shown in FIG. 2D, the inner cavity 112 can include one or more internal radially projecting portions 114 or other inwardly directed features (e.g., ridges), such that the inner diameter of the flange provides a lumen having a reduced diameter in the region of the internal radially projecting portion 114, or varies in size in other ways. In some variations, the various diameters of the inner cavity are configured to match the tapered dimensions of the nasal spray tip intended to be inserted into the inner cavity 112 so as to be compatible with a particular type of nasal spray tip (e.g., the brand or size of the nasal spray bottle). Maintaining a tight fit between the inner cavity and the nasal spray tip can, for example, help to lock or hold the nasal spray guide onto the nasal sprayer.

[0022] In some variations, the diameter of the lumen 112 may be adjustable to fit the size and / or shape of various nasal sprayer tips. For example, the inner surface of the lumen 112 may include or be lined with a conforming material (e.g., silicone or other elastomer) that can be compressed to adapt to a range of nasal sprayer tip sizes and / or shapes. Such conforming material may be disposed along the entire inner surface of the lumen 112 or only along a portion of the inner surface of the lumen 112 (e.g., a conforming ring). As another example of an adjustable lumen 112, the flap 110 may include one or more circumferentially distributed radially flexible members that are biased inwardly but deflect outwardly to receive and adjustably clamp the nasal sprayer tip 12 therebetween. Such radially flexible members may be, for example, circumferential or arcuate flexible members (e.g., helical arms) that extend laterally around the lumen or longitudinal flexible members that extend axially along the lumen.

[0023] A tight fit between the lumen 112 and the nasal sprayer tip 12 received within the nasal spray guide 100 can, as described above, help hold the nasal spray guide on the nasal sprayer 10, but additionally or alternatively, the nasal spray guide 100 can include one or more engagement features that help couple the nasal spray guide to the nasal sprayer 10. For example, the nasal sprayer 10 may be configured to snap fit onto the nasal sprayer tip (e.g., via an interlock engagement mechanism on the flap 110 and a portion of the nasal sprayer 10, such as the nasal sprayer tip 12 or the pump actuation surface 14). As another example, the nasal sprayer 10 may fit (e.g., with a slip fit) onto the nasal sprayer tip and be axially held in place using an arcuate clip (e.g., a C-shaped clip) disposed on or adjacent to the nasal sprayer 10. As another example, a friction surface (e.g., a textured surface, an elastomeric lining, or a gasket) on the inner surface of the lumen 112 can help engage and / or hold the nasal spray guide on the nasal sprayer tip.

[0024] In some variations, the flange 110 may include a single ring-shaped component that defines a lumen therethrough. However, the flange 110 may alternatively include a plurality of flanges that may be adjustable to form a lumen. For example, as shown in FIG. 2E, in an exemplary variation, the flange may include two longitudinal flanges 110a, 110b. The flange 110a can include respective shoulder portions 120a and semi-circular cutouts 112a, and the flange 110b can include respective shoulder portions 120b and semi-circular cutouts 112b. These flanges 110a, 110b may be combined around the nasal nebulizer tip to form a circular lumen from the respective semi-circular cutouts. FIG. 2F shows another exemplary variation that includes two longitudinal flanges (having respective shoulder portions 120a, 120b, and semi-circular cutouts 112a, 112b) configured to be combined in a similar manner along an axis different from the variation shown in FIG. 2E. Or, when the flanges 110 are combined, any suitable number of portions (e.g., three, four, etc.) may be included to form a lumen for receiving the nasal nebulizer tip. The flanges may be of equal size (e.g., mirror halves) or of unequal size. In some variations, the flanges may be separately formed and connected via suitable connectors (e.g., hinges, balls and sockets, etc.), but in other variations, at least some of the flanges may be integrally formed with respect to each other via a suitable connector-like member (e.g., a living hinge) and may be adjustable. The plurality of flanges may be locked together around the nasal nebulizer tip by any suitable engagement features such as those described above.

[0025] As described above, the shoulder 120 may function as a depth limiter and / or a guide for positioning the nasal nebulizer tip relative to the user's nose. The shoulder 120 may be integrally formed with the flap 110, or the shoulder 120 may be formed separately from the flap 110 and subsequently joined (e.g., using one or more fasteners, epoxy, mechanical mating features, etc.). The shoulder 120 may be configured to contact the user's nose and may include a shoulder surface 122 that can be angled relative to the lumen 112 of the flap 110. In some variations, the shoulder surface 122 may be angled obliquely relative to the lumen 112 and may assist in guiding the overall directional thrust of the nasal spray from the nasal nebulizer tip when the shoulder surface 122 is positioned relative to the nose. For example, as shown in FIG. 1C, the shoulder surface 122 may be angled by an angle θ relative to the lumen 112. In some variations, the angle θ may be about 40° - 90°, or 60° - 80°, or about 70° - 80°. In one variation, the nasal spray guide 100 is configured to assist in guiding the distribution of the nasal spray (axially from the distal tip of the nasal nebulizer tip) to the inferior turbinate when the nasal nebulizer tip is inserted into the nose, and the angle θ may be about 75°. As shown in FIG. 1C, the entire shoulder 120 may be angled by the angle θ. However, in some variations, only a portion of the shoulder including the shoulder surface 122 may be angled by the angle θ. For example, as shown in FIG. 3, the shoulder 120 may be wedge-shaped, the first shoulder surface 122 may be angled obliquely by the angle θ relative to the lumen 112, and the second shoulder surface 124 may be on the opposite side of the first shoulder surface 122 and orthogonal to the lumen 112.

[0026] Furthermore, it should be understood that while the shoulder surface 122 is generally shown as substantially planar in FIG. 1A, in some variations the shoulder surface 122 may be concave or convex. For example, the shoulder surface 122 may curve away from the flap 110 (e.g., configured to curve around the user's nose during use), or may curve towards the flap 110 (e.g., configured to curve away from the user's nose during use).

[0027] The shoulder surface 122 configured to seat or abut against the user's nose may have any suitable overall shape. For example, as shown in FIG. 1B, the shoulder surface 122 may have a generally rectangular shape when viewed from above. However, the shoulder surface 122 may have any suitable polygonal shape having a suitable number of sides (e.g., 3, 4, 5, 6, or more), such as a square or trapezoid (e.g., FIG. 4A). As another example, the shoulder surface 122 may be any combination of shapes such as circular or oval (e.g., FIGS. 4B and 4C), or partially oval and partially polygonal (e.g., FIG. 4D).

[0028] In addition, as described above, the shoulder surface 122 may be configured to at least partially surround the lumen 112 into which the nasal spray tip is inserted. In some variations, the lumen may be completely surrounded by the shoulder surface 122 (e.g., FIGS. 4A-4D). The lumen 112 may be disposed at approximately the center of the shoulder surface (e.g., FIGS. 4A and 4B), or offset from the center of the shoulder surface (e.g., FIGS. 4C and 4D) such that the lumen is closer to one end of the shoulder surface 122 than the other. Alternatively, in some variations, the lumen 112 of the flap may be only partially surrounded by the shoulder surface 122 (e.g., FIG. 4E). Further, similar to that described above for a nasal spray guide including a plurality of flap portions, in some variations, the lumen 112 may be formed from a plurality of shoulder portions (e.g., as shown in FIGS. 2E and 2F).

[0029] Since the shoulder surface 122 is configured to seat on the user's nose, the shoulder surface 122 may include one or more features in some variations that help maintain the placement of the shoulder surface 122 relative to the skin. For example, the shoulder surface 122 may include texture features (e.g., rims, ridges, channels, stops, raised dots, etc.), and / or conformable and / or friction materials (e.g., silicone resin). Additionally or alternatively, the shoulder surface 122 may include one or more features (e.g., conformable materials, rounded edges, etc.) to help improve the user's comfort when the shoulder surface 122 is positioned against the skin.

[0030] In some variations, the nasal spray guide 100 may include a lid 150 that functions to cover or otherwise surround the nasal spray tip during use of the nasal spray, such as to help keep the nasal spray tip clean when the nasal spray is not in use. The lid 150 may define a cavity 152 and may be configured to engage the shoulder 120 such that the cavity 152 and the lumen 112 are substantially aligned. As shown and described in more detail below, when the lid and the shoulder are engaged in such a manner, the nasal spray tip inserted through the lumen 112 of the flange 110 may be received within the cavity 152 and thus may be covered by the closed end of the lid. For example, as shown in FIG. 6A, the lid 150 may be removed from the nasal spray tip 12 of the nasal spray 10 when the user desires to administer fluid from the nasal spray 10 using the nasal spray 10. Thereafter, the lid 150 may be returned to engage the shoulder 120 and cover the nasal spray tip 12 during such fluid administration by the nasal spray 10, as shown in FIG. 6B.

[0031] In some variations, the lid cavity 152 may have an open end at least partially surrounded by a lid surface 154 configured to abut the shoulder surface 122 when the lid 150 is disposed over the nasal spray tip. Thus, the lid surface 154 may be angled relative to the lumen 112 in a manner similar to the shoulder surface 122 and / or, alternatively, may be complementary to the shoulder surface 122 to provide a seal such that the nasal spray tip is encapsulated between the lid 150 and the shoulder surface 122. Further, in some variations, the lid 150 may include one or more features useful for aligning and / or securing the lid 150 relative to the shoulder surface 122. For example, the lid 150 and / or the shoulder 120 may include one or more mechanical mating features (e.g., snap-fit features) to assist in rotating and / or laterally aligning the cavity 152 and the lumen 112 and / or to releasably lock the lid 150 and the shoulder 120 together. As another example, the lid 150 and / or the shoulder 120 may include a magnet or magnetic material to assist in rotating and / or laterally aligning the cavity 152 and the lumen 112 and / or to releasably engage the lid 150 and the shoulder 120 together. The lid 150 may be configured to engage the shoulder 120 with an axial movement (e.g., up and down movement) or may engage via a threaded feature and / or other suitable discrete fastener.

[0032] As shown in FIG. 1A, in some variations, the lid 150 may generally be shaped like a frustum or cone. However, it should be understood that in other variations, the lid 150 may have any suitable shape or profile (e.g., cylindrical, prismatic, stepped profile, etc.). Additionally or alternatively, the outer surface of the lid 150 may have one or more features for improving the gripping and / or operability of the lid 150. For example, in some variations, the outer surface of the lid 150 may include one or more outwardly or inwardly expressed textural features such as lips or flanges, rings, bumps, ridges, grooves, and / or channels, and / or one or more friction materials (e.g., rubber) for improving the ability of a user to grip the lid 150.

[0033] As shown in FIG. 1A, the cavity 152 may generally be cylindrical. However, in other variations, it should be understood that the cavity 152 may have any suitable shape or profile (e.g., tapered, frustoconical, prismatic, stepped profile, etc.). The overall dimensions (e.g., diameter, depth, etc.) and geometric shape may vary, for example, according to the specific dimensions and characteristics of the nasal nebulizer tip that the lid 150 is intended to cover. In some variations, the cavity 152 may be sized and shaped to allow a gap (e.g., 1 mm - 2 mm) between the nasal nebulizer tip and the inner surface of the lid 150. Alternatively, in some variations, the cavity 152 may be substantially the same size and shape as the exposed portion of the nasal nebulizer tip such that the lid 150 fits somewhat snugly over the nasal nebulizer tip. Additionally or alternatively, in some variations, the cavity 152 or other features of the lid 150 may have an adjustable size and / or shape to conform to a particular type of nasal nebulizer tip. For example, the cavity 152 may be lined with a conformable material and / or may include an extendable material or structure (e.g., an accordion pleat) for the lid 150 to adjust to nasal nebulizer tips of various lengths.

[0034] In some variations, the lid 150 may include one or more anti-infective substances or other features (e.g., antibacterial, antifungal, etc.) to help reduce the growth of pathogens on the nasal nebulizer tip during use. For example, the lid 150 may be impregnated with an antibacterial material such as silver. As another example, the lid 150 may include an ultraviolet light source (e.g., UV-C) for selectively disinfecting the nasal nebulizer tip when the nasal nebulizer tip is inserted into the cavity 152.

[0035] In some variations, the lid 150 may be separated from the rest of the nasal spray guide 100, as shown in FIG. 1A. However, in other variations, the lid 150 may be coupled to another portion of the nasal spray guide 100. For example, as shown in FIG. 5A, the lid 150 may be coupled to the shoulder 120. As another example, as shown in FIG. 5B, the lid 150 may be coupled to the flange 110. The lid 150 may be coupled to the rest of the nasal spray guide 100 via a tether 140, such as a living hinge or a flexible member, that extends between the lid 150 and the flange 110 and / or the shoulder 120. The tether 140 may be formed integrally with the lid 150 and the flange 110 and / or the shoulder 120 (e.g., by injection molding), or may be separately formed and coupled to the lid 150 and the flange 110 and / or the shoulder 120 via one or more suitable fasteners (e.g., epoxy, mechanical connectors, snap-fit features, etc.). The tether 140 may be permanent or removable. The length of the tether 140 may be long enough so as not to overly restrict the movement of the lid (e.g., to allow the lid to be placed over the nasal spray tip and removed from the nasal spray tip). Thus, the length of the tether 140 may depend at least in part on the dimensions of the nasal spray tip and the relative positions of the attachment points of the ends of the tether 140, but in some variations, the length of the tether 140 may be at least 2 cm, at least 3 cm, at least 4 cm, or at least 5 cm or more.

[0036] In some variations, the tether 140 may be biased toward a predetermined shape so that the lid 150 is not aligned with the inner cavity 112 of the flange (e.g., a linear shape, an arcuate shape, or any other suitable shape biased to leave the nasal spray tip uncovered). Or, in some variations, the tether 140 may be biased toward a predetermined shape so that the lid 150 is aligned with the inner cavity 112 of the flange (e.g., an arcuate or other suitable shape biased to remain covering the nasal spray tip). In yet other variations, the tether may lack a bias toward any particular predetermined shape. For example, the tether may include a freely movable cord-like member, or a formable wire member that substantially retains the shape or configuration in which the lid and tether are arranged when operated.

[0037] The nasal spray guide 100 is mainly described herein as including the lid 150, but in some variations, the nasal spray guide 100 may omit the lid 150. For example, the nasal spray guide 100 may be configured for limited use (e.g., one use for one nostril, or two uses for both left and right nostrils) and may be discarded after the limited use.

[0038] In some variations, the nasal spray guide may be intended to be oriented in a predetermined orientation relative to a landmark on the user's body. For example, the nasal spray guide may be oriented such that an angled shoulder surface (e.g., shoulder surface 122) helps position the nasal spray tip toward a fixed body structure of the user's nose. In these variations, the nasal spray guide may include one or more alignment indicator portions 130 (e.g., as shown in FIG. 1B) to assist the user in orienting the nasal spray guide in a predetermined orientation during use. The alignment indicator portion may be disposed on any suitable portion of the nasal spray guide including the collar portion and / or the shoulder portion (e.g., shoulder surface 122). Examples of alignment indicator portions include formed features, labels applied to the surface, color-coded materials, other suitable marks, etc. For example, in some variations, the alignment indicator portion may include an arrow or other suitable graphic, a text label (e.g., "S" for septum), a pigment deposit in the shoulder or collar material (e.g., a differently colored portion of the shoulder surface). Further, in some variations, the shape of the shoulder and / or collar itself may help specify a predetermined orientation of the nasal spray guide. For example, the shoulder may have a teardrop shape or a tapered shoulder surface that narrows such that the shoulder surface itself functions as an alignment indicator portion like an arrow. As another example, on the side of the shoulder intended to be disposed on the side of the nose, the shoulder surface may include an outer rim or lip configured to curve upward around the side of the nose (e.g., the ala). Such an upward curve, for example, helps conform the entire shoulder surface 122 to the nose and can prevent the user from misplacing the outer edge or lip, for example, inside the nose closer to the nasal septum.

[0039] In one exemplary variation, the nasal spray guide may be oriented such that the angled shoulder surface is angled away from the user's nasal septum, as shown in FIG. 6A. This can help guide the user, for example, when directing the nasal spray tip 12 (and the nasal spray plume dispensed from the nasal spray tip) towards the user's turbinate. Accordingly, the alignment marker may be configured to designate the side of the shoulder surface that is closest to the nasal septum and further away from the side of the nose (alternatively, design the side of the shoulder surface that is furthest from the nasal septum and closer to the side of the nose).

[0040] Some or all of the features of the nasal spray guide described herein may include a biocompatible rigid or semi-rigid material (e.g., a suitable plastic) to sufficiently retain its outer shape and form to ensure that its shoulder functions as a depth limiter by providing an appropriate abutment surface. The nasal spray guide 100 may be formed in some variations by any suitable manufacturing process such as injection molding, casting, 3D printing, and / or suitable machining processes (e.g., turning). The nasal spray guide 100 may be composed of a thermoplastic polymer having a softness "rubber feel" and retaining its shape at room temperature. In some variations, the thermoplastic polymer may include styrene, ethylene, butylene, or combinations thereof. In some variations, the thermoplastic polymer may be Everlon® TM-42C, a styrene ethylene butylene styrene block copolymer. The thermoplastic polymer may include an antibacterial agent such as Withstand™ (Avient) to prevent bacterial accumulation.

[0041] To use the nasal spray guide, the user can position at least a portion of the nasal sprayer (e.g., the nasal sprayer tip 12) through the lumen 112 of the collar portion 110, which seats on the nasal sprayer and has the spray outlet end of the nasal sprayer tip 12 exposed outside the collar. The user may insert the nasal sprayer tip 12 into their nostril until the shoulder 120 of the nasal spray guide seats on the user's nasal surface (e.g., the nasal floor), thereby guiding an appropriate insertion depth for the nasal sprayer tip 12. The user may align the alignment indicator portion on the nasal spray guide with a physical landmark, and / or the angle of the shoulder 120 can help guide the orientation of the nasal sprayer tip to a predetermined orientation, thereby targeting the intended tissue location (e.g., the lateral nasal concha) at the nasal sprayer tip. For example, in one variant, the nasal spray guide can include an alignment indicator portion that the user aligns towards the nasal septum, and the user may direct the outlet of the nasal sprayer tip towards their lateral nasal concha. Once the nasal sprayer is positioned at the appropriate depth and / or angle, the user can activate the nasal sprayer to administer fluid from the nasal sprayer. Optionally, the same procedure may be repeated in the opposite nostril. Following fluid administration, the user can disinfect the nasal sprayer tip (e.g., with an alcohol wipe) and can cover the nasal sprayer tip with the lid 150 of the nasal spray guide. Alternatively, the nasal spray guide may be removed from the nasal sprayer and discarded.

[0042] Figures 7A and 7B show upper and lower side perspective schematic views of an exemplary variant of the nasal spray guide 700. Generally, the nasal spray guide 700 is similar to the above-described nasal spray guide 100 and has additional features described below. As shown in Figure 7A, the nasal spray guide 700 can include a collar portion 710 that includes a lumen 712 and a shoulder portion 720 that includes a shoulder surface that extends radially from the lumen 712. The lumen 712 may be configured to receive the nasal sprayer tip of a nasal sprayer pump or other device (e.g., receiving the entire nasal sprayer tip such that the distal nozzle end of the nasal sprayer tip is exposed above the shoulder 720).

[0043] The flange portion 710 can be configured to be disposed around the nasal tip of the nasal sprayer, such as above the operable pump of the nasal sprayer. The flange portion 710 can have a generally circular cross-sectional shape, and a generally circular lumen 710 is disposed at the center of the flange portion 710. However, in other variations, the flange and / or lumen may have other suitable cross-sectional shapes. The lumen 712 may include one or more circumferentially distributed protrusions 714 extending radially inward. As shown in FIGS. 7A and 7B, the protrusions 714 (which can be interconnected by a ring 715) can narrow the diameter of the lumen 712 towards the end of the flange portion 710 proximate the shoulder 720, thereby helping to configure the lumen 712 to a size that fits the tapered nasal tip of the nasal sprayer.

[0044] As shown in FIGS. 7A and 7B, the shoulder 720 can include an elliptical surface and can be disposed at one end of the flange portion surrounding the lumen 712, but in other variations, the shoulder 720 may have other suitable shapes (e.g., rectangular, etc.). The shoulder 720 may have a rounded or beveled edge (e.g., to help reduce the risk of injury when the skin contacts the shoulder 720). In some variations, the shoulder 720 may be formed integrally with the flange portion 710 (e.g., by injection molding), but in other variations, the flange portion 710 and the shoulder 720 may be formed separately and joined together (e.g., using epoxy, interlock features, one or more fasteners, etc.).

[0045] As shown in FIG. 8A, the elliptical surface of the shoulder 720 (the surface intended to be disposed against the user's nasal surface) may be angled obliquely with respect to the lumen 112 of the flange portion 710 at an angle θ. The angle θ may be, for example, about 60° - 85°, or about 75°.

[0046] The nasal spray guide 700 can further include a lid 750 having a cavity 752. The lid 750 and / or the cavity 752 can have a stepped outer shape, and the progressively narrowing diameters of two or more steps terminate at the closed lid end. Further, the lid 750 can include one or more gripping tabs 756 that provide an outwardly extending surface that a user can contact to operate the lid 750. For example, the lid 750 may include one gripping tab 756, two gripping tabs 756 on both sides of the lid 750, or more gripping tabs. The open end of the lid 752 may also have a surface angled at an angle θ so as to form a substantial seal when disposed against the elliptical surface of the shoulder 720 (FIG. 8B).

[0047] As shown in FIGS. 8A and 8B, the lid 750 can be attached to the shoulder 720 using a tether 740. Additionally or alternatively, the lid may be attached to the flap 710 using the same tether or a different tether. The tether 740 is shown as a flexible rectangular member, but the tether 740 can have any suitable form (e.g., a cord-like member) for connecting the lid 750 to the rest of the nasal spray guide. The tether 740 may be integrally formed with the lid 750, the flap 710, and / or the shoulder 720, or may be formed separately from and coupled to at least one of the lid, the flap, and the shoulder (e.g., using epoxy, interlock features, one or more fasteners, etc.). The tether can be flexible such that the lid 750 can be moved between a lidless configuration (FIG. 8A) where the nasal spray tip 12 is exposed and a lidded configuration (FIG. 8B) where the nasal spray tip 12 received within the cavity 752 is covered.

[0048] As best shown in FIG. 7A, in some variations, the nasal spray guide 720 may include an alignment indicator portion 730. In some variations, the alignment indicator portion 730 may be positioned on the side of the shoulder 720 that is intended to be adjacent to the nasal septum when the combination of the nasal spray guide 700 and the nasal sprayer is utilized to administer fluid. The alignment indicator portion 730 is shown in FIG. 7A as an arrow integrally formed (e.g., molded) on the shoulder surface. However, similar to the alignment indicator portion 130 described above, other variations and positions of the alignment indicator portion 730 are possible.

[0049] The use of the nasal spray guide 700 is substantially the same as that described above for the nasal spray guide 100. For example, FIG. 8A shows the configuration of the nasal spray guide 700 disposed on the nasal sprayer 10, and the distal end of the nasal sprayer tip 12 is exposed beyond the flap portion 710 and the shoulder 730. In this configuration, the lid 750 is detached from the shoulder 720, and the user may orient the nasal sprayer such that the alignment indicator portion 730 points towards the nasal septum, and then insert the nasal sprayer tip 12 into their nostrils until the shoulder 720 abuts against the user's nasal surface. The user may then activate the nasal sprayer to administer fluid from the nasal sprayer. Thereafter, the user may remove the nasal sprayer tip 12 from their nostrils, repeat the procedure over the other nostril (if desired or appropriate), and then cover the nasal sprayer tip 12 with the lid 750 (or remove the nasal spray guide for disposal or storage, etc.). (Example) Exemplary Nasal Spray Guide

[0050] Figures 9A - 9E show various exemplary schematic views of an exemplary variation of the nasal spray guide 900, which is substantially similar to the nasal spray guide 700 shown in FIGS. 7A - 7B and FIGS. 8A - 8B and is designed to be used with an Aptar® CPS (Cartridge Pump System) pump-type nasal sprayer. For example, the nasal spray guide 900 includes a flange 910 having a lumen, a shoulder 920 extending radially outward from the flange 910, and a lid 950 attached to the shoulder 920 by a tether 940. The flange 910 has a lumen that includes a first, wider lumen portion 912a and a narrower lumen portion 912b whose diameter is defined by the distance between a plurality of opposing radially projecting portions 914 within the lumen. The surface of the shoulder 920 further includes an arrow-shaped alignment indicator portion 930. All dimensions in FIGS. 9A - 9E are represented in millimeters.

[0051] Figures 10A - 10E show various exemplary schematic views of another exemplary variation of the nasal spray guide 1000, which is similar to the nasal spray guide 900 shown in FIGS. 9A - 9E and is designed to be used with an Aptar® CPS nasal sprayer, except that it has a longer flange and no lid or tether. For example, the nasal spray guide 1000 includes a flange 1010 having a lumen and a shoulder 1020 extending radially outward from the flange 1010. The flange 1010 has a lumen that includes a first, wider lumen portion 1012a and a narrower lumen portion 1012b whose diameter is defined by the distance between a plurality of opposing radially projecting portions 1014 within the lumen. The surface of the shoulder 1020 further includes an arrow-shaped alignment indicator portion 1030. All dimensions in FIGS. 10A - 10E are represented in millimeters.

[0052] The nasal spray guide 900 as shown in FIGS. 9A - 9E and the nasal spray guide 1000 as shown in FIGS. 10A - 10E are designed to be used with specific nasal sprayer models, but other embodiments of the nasal spray guide as described herein can be suitably designed to be used with other nasal sprays having other form factors and can be configured with a pump-type sprayer or with an injection-type sprayer, as will be understood. (Spray Characteristic Test)

[0053] In certain variations, when the nasal spray guide is placed over the nozzle of the nasal spray pump, it can be configured so that the nasal spray guide does not obstruct the spray nozzle orifice and does not affect the spray functionality of the pump, such as pump delivery, spray pattern, droplet size distribution, and plume shape. To study the effect of the nasal spray guide embodiments on the spray generation characteristics of the nasal sprayer, a spray characteristics test was conducted. The studied spray generation characteristics include pump delivery (PD), actuation force (AF), spray pattern (SP), droplet size distribution (DSD), and plume shape (PG). As shown in FIG. 11, an embodiment of the nasal spray guide 1000 shown in FIGS. 10A - 10E was placed on an Aptar® CPS nasal sprayer, contained the TYRVAYA® composition, and the nasal sprayer was operated under normal use conditions. As detailed below, a comparison of the spray generation characteristics with and without the nasal spray guide confirmed that the placement of the nasal spray guide did not affect the spray generation characteristics of the nasal sprayer.

[0054] Pump delivery (PD) was measured in milligrams (mg) of the therapeutic composition ejected from the nasal sprayer per event. The results of the comparison are shown in Table 1 (n = 10 for each condition). As shown in the table, there was no substantial difference in PD among the nasal sprayers regardless of the presence or absence of the nasal spray guide.

[0055]

Table 1

[0056] Actuation force (AF) was measured in kilograms (kg) of the force generated by the nasal sprayer per actuation event. The results of the comparison are shown in Table 2 (n = 10 for each condition). As shown in the table, there was no substantial difference in AF among the nasal sprayers regardless of the presence or absence of the nasal spray guide.

[0057]

Table 2

[0058] The spray pattern (SP) was measured as the spray shape generated by the nasal sprayer for each actuation event, including Dmax (the diameter of the largest droplet in the spray), the ellipticity. The results of the comparison are shown in Table 3 (n = 10 for each condition). As shown in the table, there was no substantial difference in SP among the nasal sprayers regardless of the presence or absence of the nasal spray guide.

[0059]

Table 3

[0060] The droplet size distribution (DSD) generated by the nasal sprayer for each actuation event was also compared. The results of the comparison are shown in Table 4 (n = 10 for each condition). The average Dv value provides a measure of the DSD of the spray particles. "Average Dv10" refers to the spray particle diameter larger than 10% of all spray particles in the actuation event. "Average Dv50" refers to the spray particle diameter larger than 50% of all spray particles in the actuation event. "Average Dv90" refers to the spray particle diameter larger than 90% of all spray particles in the actuation event. As shown in the table, there was no substantial difference in DSD among the nasal sprayers regardless of the presence or absence of the nasal spray guide.

[0061]

Table 4

[0062] The plume geometry (PG) of the plume generated by the nasal sprayer for each actuation event was also compared. The results of the comparison are shown in Table 5 (n = 10 for each condition). As shown in the table, there was no substantial difference in PG among the nasal sprayers regardless of the presence or absence of the nasal spray guide.

[0063]

Table 5

[0064] In order to provide a complete understanding of the present invention, the foregoing description has used specific technical terms for illustrative purposes. However, it will be apparent to those skilled in the art that specific details are not required to practice the present invention. Accordingly, the foregoing description of specific embodiments of the present invention is presented for purposes of illustration and description. They are not intended to be exhaustive or to limit the invention to the precise forms disclosed, and obviously many modifications and variations are possible in light of the above teachings. The embodiments were chosen and described in order to explain the principles of the invention and its practical application, thereby enabling others skilled in the art to utilize the invention and various embodiments with various modifications as are suited to the particular use contemplated. It is intended that the scope of the present invention be defined by the following claims and their equivalents.

Claims

1. A nasal spray guide, comprising: a flange defining a lumen configured to receive a distal end of a nasal sprayer; a shoulder extending radially outward from the flange, the shoulder having a shoulder surface angled with respect to the lumen; The nasal spray guide comprising the above.

2. The nasal spray guide according to claim 1, further comprising a lid defining a cavity and configured to engage with the shoulder, whereby the cavity and the lumen are substantially aligned.

3. The nasal spray guide according to claim 1, wherein the shoulder surface is inclined obliquely with respect to the lumen.

4. The nasal spray guide according to claim 1, wherein the shoulder surface is inclined with respect to the lumen at an angle of about 60° - 80°.

5. The nasal spray guide according to claim 1, wherein the shoulder surface substantially surrounds the lumen.

6. The nasal spray guide according to claim 1, wherein the shoulder surface is substantially planar.

7. The nasal spray guide according to claim 1, wherein the shoulder surface is substantially planar, substantially surrounds the lumen, and is inclined obliquely with respect to the lumen.

8. The nasal spray guide according to claim 7, wherein the shoulder surface is inclined obliquely with respect to the lumen at an angle θ of about 60° - 80°.

9. The nasal spray guide according to claim 1, wherein the shoulder surface is substantially elliptical.

10. The nasal spray guide according to claim 1, wherein the inner diameter of the lumen varies.

11. The guide according to claim 10, wherein the inner surface of the flange comprises one or more radially inward protrusions.

12. The nasal spray guide according to claim 2, wherein the lid is coupled to at least one of the flange and the shoulder.

13. The nasal spray guide according to claim 12, wherein the lid is coupled to at least one of the flange and the shoulder by a tether.

14. The nasal spray guide according to claim 13, wherein the tether comprises a flexible member.

15. The nasal spray guide according to claim 1, further comprising an alignment indicator.

16. The nasal spray guide according to claim 15, wherein the alignment indicator comprises an arrow on the shoulder.

17. The nasal spray guide according to claim 1, wherein the nasal spray guide is composed of a thermoplastic polymer.

18. The nasal spray guide according to claim 17, wherein the thermoplastic polymer contains an antibacterial agent.

19. A method for assisting the administration of fluid from a nasal sprayer, comprising: providing a nasal spray guide comprising a flap portion defining a lumen and a shoulder portion extending radially outward from the flap portion; positioning at least a portion of the nasal sprayer within the lumen such that a distal portion of the nasal sprayer is exposed; inserting the distal portion of the nasal sprayer into a nostril of a user until the shoulder portion of the nasal spray guide seats against the nasal surface of the user; activating the nasal sprayer while the shoulder portion of the nasal spray guide is seated against the nasal surface of the user; A method comprising.

20. The method of claim 19, wherein the shoulder portion has a shoulder surface that is obliquely inclined with respect to the lumen.

21. The method of claim 20, further comprising orienting the nasal spray guide such that the shoulder surface is angled away from the nasal septum of the user.

22. The method of claim 21, wherein the nasal spray guide has an alignment indicator portion, and the step of orienting the nasal spray guide comprises aligning the alignment indicator portion with a body landmark on the user.

23. The method of claim 19, further comprising removing the nasal sprayer tip from the nostril and covering the nasal sprayer tip with a cap.

24. The method of claim 23, wherein the cap is coupled to at least one of the flap portion and the shoulder portion by a tether.

25. The method of claim 20, wherein the shoulder surface is substantially planar and substantially surrounds the lumen.

26. The method of claim 20, wherein the portion of the nasal sprayer disposed within the lumen has a nasal sprayer tip, and the exposed distal portion has a spray outlet end of the nasal sprayer tip.

27. The method of claim 25, wherein the portion of the nasal sprayer disposed within the lumen has a nasal sprayer tip, and the exposed distal portion has a spray outlet end of the nasal sprayer tip.

28. The method of claim 27, wherein the inserting step comprises inserting the nasal sprayer tip into the nostril of the user until the shoulder portion seats against the nasal surface of the user, and the nasal surface is the nasal base of the user.

29. The nasal spray guide has an alignment indicator portion, and the inserting step includes aligning the alignment indicator portion with a body landmark on the user, thereby guiding the nasal spray tip to target the intended tissue location of the user. The method according to claim 28.

30. The method according to claim 29, wherein the intended tissue location has a lateral nasal concha of the user.

31. The method according to claim 29, wherein the alignment indicator portion is disposed on a side portion of the nasal spray guide shoulder, and the user aligns the alignment indicator portion adjacent to the body landmark.

32. A nasal spray guide, a flap portion defining a lumen configured to receive a nasal spray tip, a shoulder extending radially outward from the flap portion, the shoulder having a shoulder surface inclined obliquely with respect to the lumen, A nasal spray guide comprising.

33. The method according to claim 19, wherein the fluid is a TYRVAYA (registered trademark) composition.

34. The method according to claim 19, wherein the nasal sprayer is a pump-type sprayer or a jet-type sprayer.

35. The method according to claim 19, wherein the nasal sprayer is an Aptar (registered trademark) CPS (cartridge pump system) nasal sprayer.

36. The method according to claim 35, wherein the fluid is a TYRVAYA (registered trademark) composition.

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