Nasal spray introducer

Abstract

A nasal spray introducer may include a collar defining a lumen configured to receive a nasal spray tip; a shoulder surface extending radially outward from the collar, where the shoulder surface is angled relative 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 introducer includes: positioning at least a portion of a nasal spray device in the lumen such that a distal portion of the nasal spray device is exposed; inserting the distal portion of the nasal spray device into a nostril of a user until the shoulder of the nasal spray introducer is seated against a nasal surface of the user; and actuating the nasal spray device when the shoulder of the nasal spray introducer is seated.

Description

[0001] Cross-Related Applications

[0002] This application claims priority to and is a continuation of U.S. Patent Application No. 17 / 829,286, filed on May 31, 2022, the entire contents of which are incorporated herein by reference. Technical Field

[0003] The present invention relates generally to the field of nasal spray devices. Background Art

[0004] Many substances, such as fluid medications, can be delivered intranasally using a nasal spray device. A typical nasal spray device includes a nasal spray tip and a pump coupled to a container that holds the fluid to be delivered via the nasal spray. A user can insert the nasal spray tip into his or her nostril and then actuate the pump to drive the fluid from the container to the nasal spray tip, which delivers the fluid in the form of a fine mist within the nostril.

[0005] It is often important to deliver the fluid to a certain intended tissue target (e.g., a high vascularization area for improved absorption). The location of drug delivery may be affected by, for example, the spray pattern, droplet size distribution, and specific jet geometry of the fluid dispensed by the nasal spray tip, and / or by the user's behavior of positioning the nasal spray device when actuating the pump. Although device manufacturers have a certain degree of control over spray characteristics through design considerations, they have little control over preventing users from improper operation of the device. For example, when using a conventional nasal spray device, a user may insert the nasal spray tip too deep into the nostril, which may result in the administered fluid being delivered to the back of the throat (e.g., post-nasal drip) instead of being delivered to the desired nasal tissue. As another example, some drugs are intended to be delivered toward one side of the nostril (e.g., the outside), but the user may incorrectly and / or inconsistently angle the nasal spray tip, which may result in inaccurate dosing.

[0006] Therefore, there is a need for additional systems and methods for directing the delivery of substances via nasal sprays. Summary of the invention

[0007] A nasal spray introducer can be used in conjunction with a nasal spray device to assist in administering a fluid from the nasal spray device. Generally, in some variations, the nasal spray introducer can include: a collar defining a lumen configured to receive a nasal spray tip; and a shoulder extending radially outward from the collar, wherein the shoulder includes a shoulder surface angled relative to the lumen. In some variations, the lumen can have a variable inner diameter and / or include one or more radially inward projections.

[0008] In some variations, the shoulder surface can be beveled relative to the lumen, for example at an angle between about 60 and about 80 degrees (e.g., about 75 degrees). The shoulder surface can surround at least a portion of the lumen, and in some variations can substantially surround the lumen. In some variations, the shoulder surface can be substantially planar and elliptical, although the shoulder surface can have any suitable degree of out-of-plane curvature (e.g., concave, convex) and / or shape (e.g., circular, rectangular, etc.).

[0009] In some variations, the nasal spray introducer may further include a cap that defines a cavity and is configured to engage the shoulder so that the cavity is substantially aligned with the lumen. The cap may, for example, cover and / or enclose a nasal spray tip within the cavity, for example, between administrations of fluid from the nasal spray device. In some variations, the cap may be independent and separate from the collar and shoulder of the nasal spray introducer, while in some variations, the cap may be coupled to the collar and / or shoulder of the nasal spray introducer. For example, in some variations, the cap may be coupled to the collar, the shoulder, or both by a tether (e.g., a flexible member).

[0010] In addition, in some variations, the nasal spray introducer may include an alignment indicator configured to indicate a desired predetermined orientation of the nasal spray introducer with an anatomical landmark of the user. The alignment indicator may be located, for example, on the shoulder (e.g., shoulder surface) and / or collar of the nasal spray introducer. The alignment indicator may have any suitable structure (e.g., molded features, surface-applied labels, color-coded materials, etc.) and / or convey alignment information in any suitable manner (e.g., graphics, text, color codes, etc.). In an example variation, the nasal spray introducer may include an alignment indicator molded on the shoulder surface in the form of an arrow and may be configured to indicate the side of the shoulder that should be closer to the user's nasal septum so that the shoulder surface is angled away from the septum.

[0011] In general, in some variations, a method of assisting in administering a fluid from a nasal spray device may include: providing a nasal spray introducer including a collar defining a lumen and a shoulder extending radially outward from the collar; positioning at least a portion of the nasal spray device in the lumen such that a distal portion of the nasal spray device is exposed; inserting the distal portion of the nasal spray device into a nostril of a user until the shoulder of the nasal spray introducer is seated against a nasal surface of the user; and actuating the nasal spray device when the shoulder of the nasal spray introducer is seated against the nasal surface of the user. In some variations, the shoulder surface is angled relative to the lumen. In some variations (e.g., where it is desired to administer the fluid toward a target area including an inferior turbinate), the method may include orienting the nasal spray introducer such that the shoulder surface is angled away from the nasal septum of the user. In some variations, the nasal spray introducer may include an alignment indicator and orienting the nasal spray introducer may include aligning the alignment indicator with an anatomical landmark on the user.

[0012] In some variations, the method may further include removing the nasal spray tip from the user's nostril and covering the nasal spray tip with a cap. In some variations, the cap may be coupled to the collar and / or the shoulder by a tether (e.g., a flexible member), or may be independent and separate from the rest of the nasal spray introducer. BRIEF DESCRIPTION OF THE DRAWINGS

[0013] Figures 1A to 1C Illustrative schematic diagrams depicting a side view, a top plan view, and another side view, respectively, of an example variation of a nasal spray introducer. Figure 1D An illustrative schematic diagram depicting an example variation of a nasal spray introducer coupled to a nasal spray device.

[0014] Figures 2A to 2D An illustrative schematic diagram depicting an example variation of a nasal spray introducer having a cap. Figure 2E and 2F An illustrative schematic diagram depicting an example variation of a nasal spray introducer including multiple loop portions and / or shoulder portions.

[0015] Figure 3 An illustrative schematic diagram depicting an example variation of a nasal spray introducer having a wedge-shaped shoulder.

[0016] Figures 4A to 4E Illustrative schematic diagram depicting example variations of shoulders in nasal spray introducers.

[0017] Figure 5A and 5B An illustrative schematic diagram depicting an example variation of a nasal spray introducer having a cap.

[0018] Fig. 6A and 6B An illustrative schematic diagram depicting an example variation of a nasal spray introducer for use with a nasal spray device.

[0019] Fig. 7A and 7B Illustrative schematic diagrams depicting example variations of nasal spray introducers.

[0020] Fig. 8A and 8B Illustrative schematic diagrams depicting example variations of nasal spray introducers.

[0021] Figures 9A to 9E Illustrative schematic diagrams depicting example variations of nasal spray introducers.

[0022] Figures 10A to 10E Illustrative schematic diagrams depicting example variations of nasal spray introducers.

[0023] Fig.11 Depiction Figures 10A to 10E A nasal spray introducer coupled to a nasal spray device is shown in FIG. DETAILED DESCRIPTION

[0024] Non-limiting examples of various aspects and variations of the invention are described herein and illustrated in the accompanying drawings.

[0025] Devices and methods for assisting nasal spray delivery through a nasal spray device are described herein. For example, a nasal spray introducer can be coupled to a nasal spray device and configured to guide and / or train a user to properly position the nasal spray device in his or her nose for improved delivery via the nasal spray device.

[0026] In some variations, the nasal spray introducer may include a collar defining a lumen configured to receive a nasal spray tip of a nasal spray device, and a shoulder extending radially outward from the collar. The lumen of the nasal spray introducer may be sized to allow the distal end of the nasal spray tip (e.g., the portion having a nozzle outlet) to extend beyond the collar. This arrangement ensures that the distal end of the nasal spray tip (or at least the nozzle outlet of the nasal spray tip) remains exposed, thereby helping to prevent the nasal spray introducer from interfering with or otherwise altering the nasal spray jet itself, thereby retaining the nasal spray distribution inherent in the nasal spray device. Typically, when using a combination of the nasal spray introducer and a nasal spray device, the surface of the shoulder of the nasal spray introducer may be configured to seat against the user's nose and act as a depth limiter to help prevent the nasal spray tip from being over-inserted into the nostrils. Moreover, in some variations, the surface of the shoulder may be angled (e.g., beveled) relative to the lumen to help guide the positioning of the nasal spray tip within the user's nostril at a desired angle or orientation to aim fluid delivery toward a specific desired target tissue area.

[0027] In some variations, the nasal spray introducer is removably coupled to the nasal spray device. The nasal spray introducer may be removed between uses (e.g., for cleaning or sterilization of the nasal spray introducer or the nasal spray tip), or may be placed and maintained on the nasal spray device between uses of the nasal spray device. The nasal spray introducer may include (or be configured to operate with) a removable cap that covers an exposed portion of the nasal spray tip between uses. Alternatively, in some variations, the nasal spray introducer or a portion thereof may be integrated with a nasal spray device.

[0028] Figures 1A to 1D An example variation of a nasal spray introducer 100 is shown in FIG. The nasal spray introducer 100 may include a collar 110 defining a lumen 112 configured to receive a nasal spray tip, and a shoulder 120 extending radially outward from the collar 110. Figure 1B As shown in FIG. 1 , the shoulder 120 may at least partially surround the lumen 112 so that when the nasal spray tip of the nasal spray device 10 is inserted into the lumen 112 (eg, Figure 1D ), the shoulder 120 at least partially surrounds the inserted nasal spray tip 12.

[0029] The nasal spray introducer 100 can be placed on the nasal spray tip 12 of the nasal spray device 10 in a manner that allows and does not hinder actuation of the nasal spray device 10. For example, Figure 1D , the collar 110 can be placed around the nasal spray tip 12 and on the nasal spray device 10. In some variations, the collar 110 can be seated on or near a pump actuation surface 14 that is designed to be actuated by a user's finger to operate a nasal spray pump of the nasal spray device 10. In such a configuration, the collar 110 can have a sufficient standoff height to provide sufficient clearance for the user's finger to fit in the space between the pump actuation surface 14 and the shoulder 120. For example, at least one side of the collar 110 can have a standoff 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 collar 110 adjacent to the pump actuation surface 14 may be sufficiently smaller than the diameter of the pump actuation surface 14 to leave sufficient surface area of ​​the pump actuation surface 14 for the user's fingers to manipulate the pump (e.g., at least about 1.5 cm radial distance on either side of the collar 110 not covered by the nasal spray introducer). For example, the outer diameter of the collar 110 adjacent to the pump actuation surface 14 (e.g., the lower portion of the collar 110, such as Figure 1D1. The collar 110 may be provided in a set in one of a variety of predetermined sizes (e.g., extra small, small, medium, large, extra large, etc.) or ranges of sizes. The predetermined size may correspond to a nose size and / or a nasal spray pump size, for example.

[0030] In addition, the nasal spray introducer 100 can be placed on the nasal spray tip 12 of the nasal spray device 10 so that it does not interfere with the distribution of the fluid sprayed from the nasal spray tip 12. For example, Figure 1D , the collar 110 can be placed around the nasal spray tip 12, and the height of the collar 110 and the shoulder 120 can be sized so that the distal end of the nasal spray tip 12 (e.g., including at least the nasal spray outlet 16) extends in an exposed manner beyond the shoulder 120. Since the uncovered nasal spray outlet 16 is not blocked by the nasal spray introducer 100, the nasal spray device 10 is allowed to release a nasal spray jet that is not modified by the nasal spray introducer, thereby maintaining the spray characteristics inherently provided by the design of the nasal spray device 10.

[0031] The collar 110 may function to couple the nasal spray introducer to the nasal spray device and / or act as a mount to help determine the axial position of the nasal spray introducer along the nasal spray tip and / or the depth of insertion of the nasal spray tip permitted. For example, the height of the collar 110 (in combination with, for example, the thickness of the shoulder 120) may affect the position of the shoulder 120 relative to the nasal spray tip, and thus the depth to which the nasal spray tip may be inserted into the nostril of the user.

[0032] The collar 110 may have any suitable shape. For example, Figure 1A The nasal spray introducer shown in includes a generally cylindrical collar 110. However, in other variations, the nasal spray introducer may have any suitable cross-section, such as an elliptical, triangular, square, rectangular, pentagonal, hexagonal, heptagonal, octagonal, or any suitable number of sides. In some variations, the collar 110 may have a substantially constant cross-section along its length (e.g., a prismatic or cylindrical shape having any suitable cross-section). In other variations, the collar 110 may have a varying cross-section along its length. For example, the collar 110 may be tapered, such as Figures 2B to 2D as shown in (e.g., a frustoconical shape).

[0033] Furthermore, the lumen 112 defined in the collar 110 may have any suitable shape, such as having a cross-section that is circular, oval, etc. Additionally or alternatively, as with the collar 110, the lumen 112 may have a substantially constant cross-section along its length extending from one end of the collar 110 to the opposite end of the collar 110 (e.g., as shown in FIG. 1 ). Figure 1A ), or have a varying cross-section along its length. For example, lumen 112 may vary in cross-section by being tapered or frustoconical (e.g., as shown in FIG. Figure 2A and 2B As another example, Figure 2D , lumen 112 may include one or more inner radial projections 114 or other inwardly directed features (e.g., ridges) that cause the inner diameter of the collar to provide a lumen having a reduced diameter or otherwise varying in size in the region of the inner radial projections 114. In some variations, the varying diameter of the lumen may be configured to match the tapered size of a nasal spray tip intended to be inserted into lumen 112 so as to be compatible with a particular type of nasal spray tip (e.g., a brand or size of nasal spray bottle). Maintaining a tight fit between the lumen and the nasal spray tip may, for example, help lock or retain a nasal spray introducer to a nasal spray device.

[0034] In some variations, the diameter of the lumen 112 may be adjustable to accommodate a variety of nasal spray tip sizes and / or shapes. For example, the inner surface of the lumen 112 may include or be lined with a conformable material (e.g., silicone or other elastomer) that can be compressed to accommodate a range of nasal spray tip sizes and / or shapes. This conformable material may be positioned 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 conformable ring). As another example of an adjustable lumen 112, the collar 110 may include one or more circumferentially distributed radial flex members that are biased inwardly but flexed outwardly to adjust to accommodate the nasal spray tip 12 between them and clamped around the nasal spray tip 12. Such radial flex members may be, for example, circumferential or arcuate flex members (e.g., spiral arms) extending transversely around the lumen, or longitudinal flex members extending axially along the lumen.

[0035] Although, as described above, a tight fit between the lumen 112 and the nasal spray tip 12 received in the nasal spray introducer 100 can help retain the nasal spray introducer to the nasal spray device 10, in addition or alternatively, the nasal spray introducer 100 can include one or more engagement features to help couple the nasal spray introducer to the nasal spray device 10. For example, the nasal spray device 10 can be configured to snap fit over the nasal spray tip (e.g., via interlocking engagement features on the collar 110 and a portion of the nasal spray device 10 (e.g., the nasal spray tip 12 or the pump actuation surface 14)). As another example, the nasal spray device 10 can fit over the nasal spray tip (e.g., a sliding fit) and be axially held in place with an arcuate clip (e.g., a C-clip) placed over or near the nasal spray device 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 retain the nasal spray introducer over the nasal spray tip.

[0036] In some variations, the collar 110 may include a single ring-shaped member defining a lumen therethrough. However, the collar 110 may alternatively include multiple collar portions that may be adjustable to form a lumen. For example, Figure 2E , in an example variation, the collar may include two longitudinal collar portions 110a and 110b. The collar portion 110a may include a respective shoulder portion 120a and a semicircular cutout 112a, and the collar portion 110b may include a respective shoulder portion 120b and a semicircular cutout 112b. These collar portions 110a and 110b may be combined around the nasal spray tip to form a circular lumen from the respective semicircular cutouts. Figure 2F Another example variation is described, in which the ring includes a Figure 2E 120a and 120b and semicircular cutouts 112a and 112b). Alternatively, the collar 110 may include any suitable number of parts (e.g., three, four, etc.) that form a lumen when combined to receive the nasal spray tip. The collar parts may be the same size (e.g., mirror image halves) or different sizes. In some variations, the collar parts may be formed separately and connected via suitable connectors (e.g., hinges, ball sockets, etc.), although in other variations, at least some of the collar parts may be integrally formed and adjustable relative to each other via suitable connector-like members (e.g., living hinges). Multiple collar parts may be locked together around the nasal spray tip with any suitable engagement features (e.g., the engagement features described above).

[0037] As described above, the shoulder 120 may act as a depth limiter and / or guide for positioning the nasal spray tip relative to the user's nostrils. The shoulder 120 may be formed integrally with the collar 110, or the shoulder 120 may be formed separately from the collar 110 and subsequently coupled to the collar 110 (e.g., with one or more fasteners, epoxies, mechanical interfitting features, etc.). The shoulder 120 may include a shoulder surface 122 that is configured to contact the user's nose and that may be angled relative to the lumen 112 of the collar 110. In some variations, the shoulder surface 122 may be angled relative to the lumen 112, such as to help guide the overall directional thrust of the nasal spray from the nasal spray tip when the shoulder surface 122 is placed against the nose. For example, as Figure 1C , the shoulder surface 122 can be angled relative to the lumen 112 at an angle θ. In some variations, the angle θ can be between about 40 degrees and about 90 degrees, or between 60 degrees and about 80 degrees, or between about 70 degrees and about 80 degrees. In an example variation in which the nasal spray introducer 100 is configured to help direct the nasal spray (axially from the distal tip of the nasal spray tip) toward the inferior turbinate when the nasal spray tip is inserted into the nostril, the angle θ can be about 75 degrees. Figure 1C As shown in FIG. 1 , the entire shoulder 120 may be angled at angle θ. However, in some variations, only a portion of the shoulder including the shoulder surface 122 may be angled at angle θ. For example, Figure 3 As shown in , the shoulder 120 may be wedge-shaped, having a first shoulder surface 122 obliquely angled at an angle θ relative to the lumen 112 , and a second shoulder surface 124 orthogonal to the lumen 112 and opposite the first shoulder surface 122 .

[0038] Furthermore, although the shoulder surface 122 is Figure 1A 1 and 2. The shoulder surface 122 is generally shown as being substantially planar in the embodiment of the present invention, but it should be understood that in some variations, the shoulder surface 122 may be concave or convex. For example, the shoulder surface 122 may be curved away from the collar 110 (e.g., configured to be curved around the user's nose during use) or may be curved toward the collar 110 (e.g., configured to be curved away from the user's nose during use).

[0039] The shoulder surface 122 configured to seat against or abut the user's nose can have any suitable overall shape. Figure 1B As shown in , the shoulder surface 122 can have a generally rectangular shape as viewed from above. However, the shoulder surface 122 can have any suitable polygonal shape with a suitable number of sides (e.g., 3, 4, 5, 6, or more), such as a square or a trapezoid (e.g., Figure 4A As another example, the shoulder surface 122 may be circular or oval (e.g., Figure 4B and 4C), or any combination of this partial ellipse and partial polygon (for example, Figure 4D ).

[0040] Additionally, as described above, the shoulder surface 122 can be configured to at least partially surround the lumen 112 through which the nasal spray tip is inserted. In some variations, the lumen can be completely surrounded by the shoulder surface 122 (e.g., Figures 4A to 4D Lumen 112 may be positioned approximately at the center of the shoulder surface (eg, Figure 4A and 4B ) or may be offset from the center of the shoulder surface (e.g. Figure 4C and 4D ), such that the lumen is closer to one end of the shoulder surface 122 than the other end. Alternatively, in some variations, the lumen 112 of the collar may be only partially surrounded by the shoulder surface 122 (e.g., Figure 4E ). In addition, similar to the description above regarding nasal spray introducers comprising multiple collar portions, in some variations, lumen 112 may be formed by multiple shoulder portions (e.g., Figure 2E and 2F ).

[0041] Because shoulder surface 122 is configured to seat against a user's nose, in some variations, shoulder surface 122 may include one or more features to help maintain placement of shoulder surface 122 against the skin. For example, shoulder surface 122 may include textured features (e.g., edges, ridges, channels, detents, bumps, etc.) and / or conformable and / or frictional materials (e.g., silicone). Additionally or alternatively, shoulder surface 122 may include one or more features (e.g., conformable materials, rounded edges, etc.) to help improve user comfort when shoulder surface 122 is placed against the skin.

[0042] In some variations, the nasal spray introducer 100 may include a cap 150 that functions to cover or otherwise enclose the nasal spray tip, for example, between uses of the nasal spray device to help keep the nasal spray tip clean when the nasal spray device is not in use. The cap 150 may define a cavity 152 and be configured to engage the shoulder 120 so that the cavity 152 is substantially aligned with the lumen 112. As shown and described in further detail below, when the cap and the shoulder are engaged in this manner, a nasal spray tip that has been inserted through the lumen 112 of the collar 110 may be received in the cavity 152 and thus covered by the closed end of the cap. For example, Fig. 6A , when a user desires to use the nasal spray device 10 to administer fluid from the nasal spray device 10, the cap 150 can be removed from the nasal spray tip 12 of the nasal spray device 10. Thereafter, the cap 150 can be returned to engage the shoulder 120 and cover the nasal spray tip 12 between such fluid administrations with the nasal spray device 10, as shown in FIG. Figure 6B As shown in .

[0043] In some variations, the cavity 152 of the cap may have an open end at least partially surrounded by a cap surface 154 that is configured to abut the shoulder surface 122 when the cap 150 is placed over the nasal spray tip. Thus, the cap surface 154 may be angled relative to the lumen 112 in a manner similar to the shoulder surface 122, and / or may otherwise be complementary to the shoulder surface 122 to provide a seal such that the nasal spray tip is enclosed between the cap 150 and the shoulder surface 122. Additionally, in some variations, the cap 150 may include one or more features to help align and / or secure the cap 150 against the shoulder surface 122. For example, the cap 150 and / or shoulder 120 may include one or more mechanically cooperating features (e.g., snap-fit ​​features) to help rotationally and / or laterally align the cavity 152 with the lumen 112, and / or releasably lock the cap 150 and the shoulder 120 together. As another example, the cap 150 and / or shoulder 120 may include magnets or magnetic materials to help rotationally and / or laterally align the cavity 152 with the lumen 112, and / or releasably engage the cap 150 with the shoulder 120. The cap 150 may be configured to engage the shoulder 120 in an axial motion (e.g., up and down motion), or may be engaged via threaded features and / or other suitable separate fasteners.

[0044] like Figure 1A As shown in , in some variations, the cap 150 may be generally conical or frustoconical in shape. However, it should be understood that in other variations, the cap 150 may have any suitable shape or profile (e.g., cylindrical, prismatic, stepped profile, etc.). Additionally or alternatively, the outer surface of the cap 150 may have one or more features to improve the grip and / or manipulability of the cap 150. For example, in some variations, the outer surface of the cap 150 may include one or more outwardly or inwardly appearing texture features (e.g., lips or flanges, rings, bumps, ridges, grooves, and / or channels), and / or one or more friction materials (e.g., rubber) to improve the user's ability to grip the cap 150.

[0045] like Figure 1A, the cavity 152 may be generally cylindrical. However, it should be understood that in other variations, the cavity 152 may have any suitable shape or profile (e.g., cone, truncated cone, prismatic, stepped profile, etc.). The overall size (e.g., diameter, depth, etc.) and geometry may vary, for example, depending on the specific size and features of the nasal spray tip that the cap 150 is intended to cover. In some variations, the cavity 152 may be sized and shaped to allow a gap (e.g., 1 mm to 2 mm) between the nasal spray tip and the inner surface of the cap 150. Alternatively, in some variations, the cavity 152 may be sized and shaped substantially similar to the exposed portion of the nasal spray tip, so that the cap 150 fits slightly snugly over the nasal spray tip. Additionally or alternatively, in some variations, the cavity 152 or other features of the cap 150 may have adjustable size and / or shape to fit a range of nasal spray tip types. For example, cavity 152 may be lined with a conformable material, and / or cap 150 may include stretchable materials or features (eg, accordion pleats) to adjust to various lengths of nasal spray tips.

[0046] In some variations, the cap 150 may include one or more anti-infective substances or other features (e.g., antimicrobial, antifungal, etc.) to help reduce the growth of pathogens on the nasal spray tip between uses. For example, the cap 150 may be impregnated with an antimicrobial material, such as silver. As another example, the cap 150 may include an ultraviolet light source (e.g., UV-C) to selectively sterilize the nasal spray tip when the nasal spray tip is inserted into the cavity 152.

[0047] In some variations, cap 150 may be separate from the remainder of nasal spray introducer 100, such as Figure 1A However, in other variations, cap 150 may be coupled to another portion of nasal spray introducer 100. For example, Figure 5A As shown in FIG. 1 , the cap 150 can be coupled to the shoulder 120. As another example, as shown in FIG. Figure 5B, the cap 150 may be coupled to the collar 110. The cap 150 may be coupled to the rest of the nasal spray introducer 100 via a tether 140 (e.g., a living hinge or flexible member) extending between the cap 150 and the collar 110 and / or the shoulder 120. The tether 140 may be, for example, integrally formed with the cap 150 and the collar 110 and / or the shoulder 120 (e.g., via injection molding), or formed separately and coupled to the cap 150 and the collar 110 and / or the shoulder 120 via one or more suitable fasteners (e.g., epoxy, mechanical connector, 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 cap (e.g., enabling the cap to be placed over and removed from the nasal spray tip). Thus, the length of tether 140 may depend at least in part on the size of the nasal spray tip and the relative position of the attachment points at the ends of tether 140, although in some variations, the length of tether 140 may be at least 2 cm, at least 3 cm, at least 4 cm, or at least 5 cm or more.

[0048] In some variations, the tether 140 may be biased toward a predetermined shape such that the cap 150 is not aligned with the lumen 112 of the collar (e.g., a straight shape, an arcuate shape, or other suitable shape that is biased toward such that the nasal spray tip is not covered). Alternatively, in some variations, the tether 140 may be biased toward a predetermined shape such that the cap 150 is aligned with the lumen 112 of the collar (e.g., an arcuate shape or other suitable shape that is biased toward such that the nasal spray tip is covered). In still other variations, the tether may not be biased toward any particular predetermined shape. For example, the tether may include a freely movable rope-like member, or may include a shaped wire member that substantially maintains the shape or form into which it is placed when the cap and tether are manipulated.

[0049] Although the nasal spray introducer 100 is primarily described herein as including the cap 150, in some variations, the nasal spray introducer 100 may omit the cap 150. For example, the nasal spray introducer 100 may be configured for limited use (e.g., once in one nostril, or twice in the left and right nostrils) and be discarded after the limited use.

[0050] In some variations, the nasal spray introducer may be intended to be oriented in a predetermined orientation relative to an anatomical landmark of a user. For example, the nasal spray introducer may be intended to be oriented so that an angled shoulder surface (e.g., shoulder surface 122) helps position the nasal spray tip toward certain anatomical structures of the user's nose. In these variations, the nasal spray introducer may include one or more alignment indicators 130 (e.g., such as a shoulder surface 122) to help the user orient the nasal spray introducer in a predetermined orientation during use. Figure 1B). The alignment indicator may be positioned on any suitable portion of the nasal spray introducer, including the collar and / or the shoulder (e.g., shoulder surface 122). Examples of alignment indicators include molded features, surface applied labels, color-coded materials, other suitable markings, and / or the like. For example, in some variations, the alignment indicator may include an arrow or other suitable graphic, a text label (e.g., an "S" for the nasal septum), coloring of the shoulder or collar material (e.g., different color segments of the shoulder surface), etc. In addition, in some variations, the shape of the shoulder and / or collar itself may help specify the intended orientation of the nasal spray introducer. For example, the shoulder may have a teardrop-shaped or tapered shoulder surface that narrows in width so that the shoulder surface itself acts as an arrow-shaped alignment indicator. As another example, on the outside of a shoulder intended to be placed on the outside of the nose, the shoulder surface may include an outer edge or lip that is configured to curve upward around the outside of the nose (e.g., the wing of the nose). For example, this upward curvature can help conform the overall shoulder surface 122 to the nose and prevent a user from mistakenly placing the rim or lip on the inside of the nose near the nasal septum.

[0051] In one example variation, the nasal spray introducer may be intended to be oriented so that the angled shoulder surface is angled away from the user's nasal septum, such as Fig. 6A . For example, this can help guide the user to aim the nasal spray tip 12 (and the nasal spray jet dispensed from the nasal spray tip) toward the user's external turbinate. Thus, the alignment mark can be configured to designate the side of the shoulder surface that should be placed closest to the nasal septum and farther from the outside of the nose (or alternatively, the side of the shoulder surface that should be designed to be placed farthest from the nasal septum and closer to the outside of the nose).

[0052] Some or all of the features of the nasal spray introducer described herein may include a biocompatible rigid or semi-rigid material (e.g., a suitable plastic) so that it sufficiently maintains its outer shape and form to ensure that its shoulder provides a suitable abutment surface to act as a depth limiter. In some variations, the nasal spray introducer 100 may be formed in any suitable manufacturing process, such as injection molding, casting, 3D printing, and / or a suitable machining process (e.g., turning). The nasal spray introducer 100 may be composed of a thermoplastic polymer that has a soft "rubbery feel" and retains its shape at room temperature. In some variations, the thermoplastic polymer may include styrene, ethylene, butylene, or a combination thereof. In some variations, the thermoplastic polymer may be TM-42C, styrene ethylene butylene styrene block copolymer. To prevent the accumulation of microorganisms, the thermoplastic polymer may include an antimicrobial agent, such as Withstand TM (Avient).

[0053] In order to use the nasal spray introducer, the user can position at least a portion of the nasal spray device (e.g., the nasal spray tip 12) through the lumen 112 of the collar 110 so that the collar 110 is seated on the nasal spray device, wherein the spray outlet end of the nasal spray tip 12 is exposed outside the collar. The user can insert the nasal spray tip 12 into their nostrils until the shoulder 120 of the nasal spray introducer is seated against the user's nasal surface (e.g., the bottom of the nose), thereby guiding the nasal spray tip 12 to an appropriate insertion depth. The user can align the alignment indicator on the nasal spray introducer with the anatomical landmark, and / or the angle of the shoulder 120 can help guide the orientation of the nasal spray tip toward a predetermined orientation, thereby aiming the nasal spray tip at an expected tissue location (e.g., the external turbinate). For example, in an example variation, the nasal spray introducer can include an alignment indicator that the user directs toward their nasal septum, and the user can aim the outlet of the nasal spray tip toward their external turbinate. Once the nasal spray device is positioned at an appropriate depth and / or angle, the user can actuate the nasal spray device to administer fluid from the nasal spray device. If necessary, the same process can be repeated on the opposite side in the opposite nostril. After administering the fluid, if desired, the user can disinfect the nasal spray tip (e.g., with an alcohol wipe) and cover the nasal spray tip with the cap 150 of the nasal spray introducer. Alternatively, the nasal spray introducer can be removed from the nasal spray device and discarded.

[0054] Fig. 7A and 7B Schematic diagrams of upper and lower perspective views of example variations of nasal spray introducer 700 are depicted. Generally, nasal spray introducer 700 is similar to nasal spray introducer 100 described above, but has additional features as described below. Fig. 7A , the nasal spray introducer 700 may include a collar 710 including a lumen 712, and a shoulder 720 including a shoulder surface extending radially from the lumen 712. The lumen 712 may be configured to receive a nasal spray tip of a nasal spray pump or other device (e.g., receive the nasal spray tip completely therethrough such that the distal nozzle end of the nasal spray tip is exposed above the shoulder 720).

[0055] The collar 710 can be configured to be placed around a nasal spray tip of a nasal spray device, for example, over an actuatable pump of the nasal spray device. The collar 710 can have a generally circular cross-sectional shape, with a generally circular lumen 710 positioned in the center of the collar 710. However, in other variations, the collar and / or lumen can have other suitable cross-sectional shapes. The lumen 712 can include one or more circumferentially distributed protrusions 714 extending radially inwardly. Fig. 7A and 7BAs shown in , projections 714 (which may be interconnected by rings 715) may narrow the diameter of lumen 712 toward the end of collar 710 proximate shoulder 720, thereby helping to configure lumen 712 to be sized to conform to a tapered nasal spray tip.

[0056] like Fig. 7A and 7B , shoulder 720 may include an elliptical surface and be disposed on one end of the collar surrounding lumen 712, although in other variations, shoulder 720 may have other suitable shapes (e.g., rectangular, etc.). Shoulder 720 may have rounded or beveled edges (e.g., to help reduce the risk of injury when skin contacts shoulder 720). In some variations, shoulder 720 may be integrally formed with collar 710 (e.g., via injection molding), although in other variations, collar 710 and shoulder 720 may be separately formed and coupled together (e.g., with epoxy, interlocking features, one or more fasteners, etc.).

[0057] like Fig. 8A , the oval surface of the shoulder 720 (the surface intended to be placed against the user's nasal surface) can be beveled at an angle θ relative to the lumen 112 of the collar 710. The angle θ can be, for example, between about 60 degrees and about 85 degrees, or about 75 degrees.

[0058] The nasal spray introducer 700 may further include a cap 750 having a cavity 752. The cap 750 and / or the cavity 752 may have a stepped profile in which two or more levels with gradually narrowing diameters terminate in a closed cap end. In addition, the cap 750 may include one or more gripping tabs 756 that provide an outwardly extending surface that a user can contact to manipulate the cap 750. For example, the cap 750 may include one gripping tab 756, two gripping tabs 756 on opposite sides of the cap 750, or more gripping tabs. The open end of the cap 752 may have a surface similarly angled at an angle θ so as to form a substantial seal ( θ ) when placed against the elliptical surface of the shoulder 720. Figure 8B ).

[0059] like Fig. 8A and 8B, the cap 750 may be attached to the shoulder 720 with a tether 740. Additionally or alternatively, the cap may be attached to the collar 710 with the same tether or another tether. The tether 740 is depicted as a flexible rectangular member, although the tether 740 may have any suitable form (e.g., a rope-like member) to connect the cap 750 to the rest of the nasal spray introducer. The tether 740 may be integrally formed with the cap 750, the collar 710, and / or the shoulder 720, or may be formed separately from and coupled to at least one of the cap, collar, and shoulder (e.g., with epoxy, interlocking features, one or more fasteners, etc.). The tether may be flexible so that the cap 750 may be in an uncapped configuration ( Fig. 8A ) and a capping configuration covering the nasal spray tip 12 received in the cavity 752 ( Figure 8B )

[0060] like Fig. 7A As best shown in FIG. 1 , in some variations, nasal spray introducer 720 may include an alignment indicator 730. In some variations, when the combination of nasal spray introducer 700 and a nasal spray device is used to administer a fluid, alignment indicator 730 may be positioned on the side of shoulder 720 that is intended to be adjacent to the nasal septum. Alignment indicator 730 may be positioned on the side of shoulder 720 that is intended to be adjacent to the nasal septum. Fig. 7A 730 is depicted as an arrow integrally formed in the shoulder surface (eg, molded into the shoulder surface). However, similar to the alignment indicator 130 described above, other variations and locations of the alignment indicator 730 are possible.

[0061] The use of nasal spray introducer 700 is substantially similar to that described above for nasal spray introducer 100. For example, Fig. 8A Depicts a configuration of a nasal spray introducer 700 disposed on a nasal spray device 10, wherein the distal end of the nasal spray tip 12 extends exposed beyond the collar 710 and the shoulder 730. In this configuration, the cap 750 is disengaged from the shoulder 720, and the user can orient the nasal spray device so that the alignment indicator 730 points to their nasal septum, then insert the nasal spray tip 12 into their nostril until the shoulder 720 abuts the user's nasal surface. The user can then actuate the nasal spray device to administer fluid from the nasal spray device. Thereafter, the user can remove the nasal spray tip 12 from their nostril, repeat the process on their other nostril (if desired or appropriate), then cover the nasal spray tip 12 with the cap 750 (or remove the nasal spray introducer, e.g., for disposal or storage).

[0062] Examples

[0063] Example Nasal Spray Introducer

[0064] Figures 9A to 9E Describe and Figures 7A to 7B8A to 8B, and is designed to be used with the nasal spray introducer 700 shown in Various illustrative schematic diagrams of example variations of a nasal spray introducer 900 for use with a CPS (Cartridge Pump System) pump-type nasal spray. For example, the nasal spray introducer 900 includes a collar 910 having a lumen, a shoulder 920 extending radially outward from the collar 910, and a cap 950 attached to the shoulder 920 by a tether 940. The collar 910 has a lumen including a first wider lumen portion 912a and a narrower lumen portion 912b whose diameter is defined by the distance between opposing radial protrusions 914 within the lumen. The surface of the shoulder 920 further includes an arrow-shaped alignment indicator 930. Figures 9A to 9E All dimensions are expressed in millimeters.

[0065] Figures 10A to 10E Describe and Figures 9A to 9E The nasal spray introducer 900 shown in FIG. 1 is similar to the nasal spray introducer 900 shown in FIG. 1 (except having a longer loop and no cap or tether), and is designed to be used with Various illustrative schematic diagrams of another example variation of a nasal spray introducer 1000 for use with a CPS nasal spray. For example, the nasal spray introducer 1000 includes a collar 1010 having a lumen, a shoulder 1020 extending radially outward from the collar 1010. The collar 1010 has a lumen including a first wider lumen portion 1012a and a narrower lumen portion 1012b whose diameter is defined by the distance between opposing radial protrusions 1014 within the lumen. The surface of the shoulder 1020 further includes an arrow-shaped alignment indicator 1030. Figures 10A to 10E All dimensions are expressed in millimeters.

[0066] Although Figures 9A to 9E The nasal spray introducer 900 shown in Figures 10A to 10E The nasal spray introducer 1000 shown in is designed for use with a particular nasal spray model, but it should be understood that other embodiments of the nasal spray introducer as described herein may be designed to be suitable for use with other nasal sprays having other form factors and configured as a pump-type spray or configured with a propellant-type spray.

[0067] Spray characteristics study

[0068] In certain variations, the nasal spray introducer may be configured such that when placed over the nozzle of a nasal spray pump, the nasal spray introducer does not inhibit the spray nozzle orifice, or otherwise affect the spray functionality of the pump, such as pump delivery, spray pattern, droplet size distribution, and jet geometry. Spray characteristics studies were conducted to study the effects of embodiments of nasal spray introducers on the spray formation characteristics of a nasal spray. The spray formation characteristics studied included pump delivery (PD), actuation force (AF), spray pattern (SP), droplet size distribution (DSD), and jet geometry (PG). Fig.11 As shown in Figures 10A to 10E The embodiment of the nasal spray introducer 1000 depicted is placed in a TYRVAYA TM Composition CPS nasal spray, and the nasal spray was actuated under standard use conditions. As described in detail below, a comparison of the spray formation characteristics with and without a nasal spray introducer confirmed that the placement of the nasal spray introducer did not affect the spray formation characteristics of the nasal spray.

[0069] Pump delivery (PD) is a measure of the milligrams (mg) of therapeutic composition ejected from the nasal spray per actuation event. The comparative results are shown in Table 1 (n=10 for each condition). As shown in the table, there is no substantial difference in PD between the nasal spray with and without a nasal spray introducer.

[0070] Table 1: Pump delivery

[0071]

[0072]

[0073] * Prime 7 = 7th prime out of 7 "Prime" actuations to prime the pump; BOL = "Beginning of Life": 1st and 2nd spray after Prime; EOL = "End of Life": 59th and 60th spray when the bottle is almost empty.

[0074] The actuation force (AF) is a measure of the kilograms (kg) of force generated by the nasal spray per actuation event. The comparative results are shown in Table 2 (n=10 for each condition). As shown in the table, there is no substantial difference in AF between the nasal spray with and without a nasal spray introducer.

[0075] Table 2: Actuation forces

[0076]

[0077] The spray pattern (SP) is a measure of the Dmax (diameter of the largest droplet in the spray), ellipticity, and shape of the spray produced by the nasal spray as each actuation event. The comparative results are shown in Table 3 (n=10 for each condition). As shown in the table, there is no substantial difference in SP between the nasal spray with and without a nasal spray introducer.

[0078] Table 3: Spray Patterns

[0079]

[0080]

[0081] The droplet size distribution (DSD) produced by the nasal spray for each actuation event is also compared. The comparison results 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 greater than 10% of all spray particles in the actuation event. "Average Dv50" refers to the spray particle diameter greater than 50% of all spray particles in the actuation event. "Average Dv90" refers to the spray particle diameter greater than 90% of all spray particles in the actuation event. As shown in the table, there is no substantial difference in DSD between the nasal spray with a nasal spray introducer and the nasal spray without a nasal spray introducer.

[0082] Table 4: Droplet size distribution

[0083]

[0084] The jet geometry (PG) of the jet produced by the nasal spray per actuation event was also compared. The comparison results are shown in Table 5 (n=10 for each condition). As shown in the table, there is no substantial difference in PG between the nasal spray with and without a nasal spray introducer.

[0085] Table 5: Jet geometry

[0086]

[0087] For the purpose of explanation, the foregoing description uses specific terms to provide a thorough understanding of the present invention. However, it will be apparent to those skilled in the art that specific details are not required in order to practice the present invention. Therefore, the foregoing descriptions of specific embodiments of the present invention are presented for the purpose of illustration and description. They are not intended to be exhaustive or to limit the present invention to the precise form disclosed; obviously, in view of the above teachings, many modifications and variations are possible. The embodiments are selected and described in order to explain the principles of the present invention and its practical application, which thereby enables other persons skilled in the art to utilize the present invention and various embodiments with various modifications as suitable for the particular use under consideration. The accompanying claims and their equivalents are intended to define the scope of the present invention.

Claims

1. A nasal spray introducer, comprising: a collar defining a lumen configured to receive a nasal spray tip; and A shoulder extends radially outward from the collar, wherein the shoulder includes a shoulder surface angled relative to the lumen.

2. The introducer of claim 1 further comprising a cap defining a cavity and configured to engage the shoulder such that the cavity is substantially aligned with the lumen.

3. The introducer of claim 1, wherein the shoulder surface is angled relative to the lumen.

4. The introducer of claim 1 wherein the shoulder surface is angled relative to the lumen at an angle between about 60 degrees and about 80 degrees.

5. The introducer of claim 1 wherein the shoulder surface substantially surrounds the lumen.

6. The introducer of claim 1, wherein the shoulder surface is substantially planar.

7. The introducer of claim 1 wherein the shoulder surface is substantially planar, substantially surrounds the lumen, and is angled relative to the lumen.

8. The introducer of claim 7, wherein the shoulder surface is beveled relative to the lumen at an angle θ between about 60 degrees and about 80 degrees.

9. The introducer of claim 1 wherein the shoulder surface is substantially elliptical.

10. The introducer of claim 1, wherein the inner diameter of the lumen varies.

11. The introducer of claim 10, wherein the inner surface of the collar includes one or more radially inward projections.

12. The introducer of claim 2, wherein the cap is coupled to at least one of the collar and the shoulder.

13. The introducer of claim 12, wherein the cap is coupled to at least one of the collar and the shoulder by a tether.

14. The introducer of claim 13, wherein the tether comprises a flexible member.

15. The introducer of claim 1, further comprising an alignment indicator.

16. The introducer of claim 15, wherein the alignment indicator comprises an arrow on the shoulder.

17. The introducer of claim 1, wherein the introducer is comprised of a thermoplastic polymer.

18. The introducer of claim 17, wherein the thermoplastic polymer comprises an antimicrobial agent.

19. A method of assisting administration of a fluid from a nasal spray device, the method comprising: providing a nasal spray introducer comprising a collar defining a lumen and a shoulder extending radially outward from the collar; positioning at least a portion of the nasal spray device in the lumen such that a distal portion of the nasal spray device is exposed; inserting the distal portion of the nasal spray device into a nostril of a user until the shoulder of the nasal spray introducer seats against a nasal surface of the user; and The nasal spray device is actuated when the shoulder of the nasal spray introducer seats against the nasal surface of the user.

20. The method of claim 19, wherein the shoulder comprises a shoulder surface that is angled relative to the lumen.

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

22. The method of claim 21, wherein the nasal spray introducer includes an alignment indicator, and wherein orienting the nasal spray introducer includes aligning the alignment indicator with an anatomical landmark on the user.

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

24. The method of claim 23, wherein the cap is coupled to at least one of the collar and the shoulder 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 spray device positioned in the lumen comprises a nasal spray tip and wherein the exposed distal portion comprises a spray outlet end of the nasal spray tip.

27. The method of claim 25, wherein the portion of the nasal spray device positioned in the lumen comprises a nasal spray tip and wherein the exposed distal portion comprises a spray outlet end of the nasal spray tip.

28. The method of claim 27, wherein the inserting comprises inserting the nasal spray tip into a nostril of the user until the shoulder seats against a nasal surface of the user, wherein the nasal surface is a floor of the user's nose.

29. The method of claim 28, wherein the nasal spray introducer includes an alignment indicator, and wherein the inserting includes aligning the alignment indicator with an anatomical landmark on the user, thereby guiding the nasal spray tip to aim at an intended tissue location on the user.

30. The method of claim 29, wherein the expected tissue location comprises an external turbinate of the user.

31. The method of claim 29, wherein the alignment indicator is located on a side of the nasal spray introducer shoulder and the user aligns the alignment indicator adjacent to the anatomical landmark.

32. A nasal spray introducer comprising: a collar defining a lumen configured to receive a nasal spray tip therethrough; and A shoulder extends radially outward from the collar, wherein the shoulder includes a shoulder surface that is angled relative to the lumen.

33. The method of claim 19, wherein the fluid is TYRVAYA TM composition.

34. The method of claim 19, wherein the nasal spray device is a pump spray or a propellant spray.

35. The method of claim 19, wherein the nasal spray device is CPS (Cartridge Pump System) nasal spray.

36. The method of claim 35, wherein the fluid is TYRVAYA TM composition.

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