Patent Application
20230381800
This invention relates generally to the field of nasal spray devices.
Many substances, such as fluid medications, may be delivered intranasally with a nasal spray device. A typical nasal spray device includes a nasal spray tip and a pump coupled to a container that holds fluid to be delivered via nasal spray. A user may insert the nasal spray tip into his or her nostril, then actuate the pump in order to drive fluid from the container to the nasal spray tip, which delivers the fluid in the form of a fine mist within the nostril.
It is often important that the fluid be delivered to a certain intended tissue target (e.g., an area with high vascularization for improved absorption). The location of drug delivery can be affected, for example, by the spray pattern, droplet size distribution, and specific plume geometry of the fluid distributed by the nasal spray tip, and/or influenced by user behavior in positioning the nasal spray device when actuating the pump. While device manufacturers have some degree of control over the spray characteristics through design considerations, they have little to no control in preventing improper operation of the device by a user. For example, when using a conventional nasal spray device, a user may insert the nasal spray tip too far into the nostril, which may result in administered fluid being delivered to the back of the throat (e.g., post-nasal drop) instead of being delivered to desired nasal tissue. As another example, some drugs are intended to be delivered toward one side (e.g., lateral side) of the nostril, but users may incorrectly and/or inconsistently angle the nasal spray tip, which may lead to inaccurate drug administration.
Thus, there is a need for additional systems and methods for guiding delivery of a substance via nasal spray.
A nasal spray guide may be used in conjunction with a nasal spray device to assist administration of a fluid from the nasal spray device. Generally, in some variations, the nasal spray guide may include a collar defining a lumen configured to receive a nasal spray tip, and a shoulder extending radially outward from the collar, where the shoulder comprises a shoulder surface angled relative to the lumen. In some variations, an inner diameter of the lumen may vary and/or include one or more radially inward projections.
In some variations, the shoulder surface may be obliquely angled relative to the lumen, such as at an angle between about 60 degrees and about 80 degrees (e.g., about 75 degrees). 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, though the shoulder surface may have any suitable degree of out-of-plane curvature (e.g., concave, convex) and/or shape (e.g., circular, rectangular, etc.).
In some variations, the nasal spray guide may further include a cap defining a cavity and configured to engage the shoulder such that the cavity and the lumen are substantially aligned. The cap may, for example, cover and/or enclose a nasal spray tip within the cavity, such as between administrations of fluid from the nasal spray device. In some variations, the cap may be standalone and separate from the collar and shoulder of the nasal spray guide, while in some variations the cap may be coupled to the collar and/or shoulder of the nasal spray guide. For example, in some variations the cap may be coupled to the collar, the shoulder, or both by a tether (e.g., flexible member).
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 an anatomical landmark of the user. The alignment indicator may, for example, be located on the shoulder (e.g., shoulder surface) and/or collar of the nasal spray guide. The alignment indicator may have any suitable structure (e.g., a molded feature, a surface-applied label, a color-coded material, etc.) and/or communicate the alignment information in any suitable manner (e.g., graphic, text, color code, etc.). In an example variation, the nasal spray guide may include an alignment indicator in the form of an arrow molded on the shoulder surface, and may be configured to indicate a side of the shoulder that should be closer to a septum of the user, such that the shoulder surface is angled away from the septum.
Generally, in some variations, a method of assisting administration of fluid from a nasal spray device may include providing a nasal spray guide 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 in a nostril of a user until the shoulder of the nasal spray guide is seated against a nasal surface of the user, and actuating the nasal spray device while the shoulder of the nasal spray guide is seated against the nasal surface of the user. In some variations, the shoulder surface is obliquely angled relative to the lumen. In some variations (e.g., where administration of the fluid toward a target region comprising the inferior turbinate is desired), the method may include orienting the nasal spray guide such that the shoulder surface is angled away from a nasal septum of the user. 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 an anatomical landmark on the user.
In some variations, the method may further include removing the nasal spray tip from the nostril of the user and covering the nasal spray tip with a cap. The cap may, in some variations, be coupled to the collar and/or the shoulder by a tether (e.g., flexible member), or may be standalone and separate from the rest of the nasal spray guide.
Non-limiting examples of various aspects and variations of the invention are described herein and illustrated in the accompanying drawings.
Described herein are devices and methods for assisting nasal spray delivery with a nasal spray device. For example, a nasal spray guide may be coupled to a nasal spray device and configured to guide and/or train a user to appropriately position a nasal spray device in his or her nose for improved delivery via the nasal spray device.
In some variations, the nasal spray guide 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 guide may be sized so as to allow a distal end of a nasal spray tip (e.g., portion having a nozzle outlet) to extend beyond the collar. This arrangement may ensure that a 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 guide from interfering with or otherwise altering the nasal spray plume itself, thereby preserving the nasal spray distribution inherent in the nasal spray device. Generally, when the combination of the nasal spray guide and nasal spray device is in use, a surface of the shoulder of the nasal spray guide may be configured to be seated against the nose of the user and function as a depth limiter to help prevent excessive insertion of the nasal spray tip into a nostril. Furthermore, in some variations, a surface of the shoulder may be angled relative to the lumen (e.g., obliquely angled), so as to help guide positioning of the nasal spray tip within the nostril of the user at a desired angle or orientation to target fluid delivery toward a particular desired target tissue region.
In some variations, the nasal spray guide may be removably coupled to the nasal spray device. The nasal spray guide may be removed between uses (e.g., for washing or sterilization of the nasal spray guide, or of the nasal spray tip), or the nasal spray guide may be placed and retained on the nasal spray device between uses of the nasal spray device. The nasal spray guide may include (or be configured to operate with) a removable cap that covers the exposed portion of the nasal spray tip between uses. Alternatively, in some variations, the nasal spray guide or a portion thereof may be integrated with a nasal spray device.
An example variation of a nasal spray guide 100 is shown in
The nasal spray guide 100 may be placed onto a nasal spray tip 12 of a nasal spray device 10 in a manner that permits, and does not obstruct, the actuation of the nasal spray device 10. For example, as shown in
Furthermore, the nasal spray guide 100 may be placed onto a nasal spray tip 12 of a nasal spray device 10 such that it does not interfere with the distribution of the fluid sprayed from the nasal spray tip 12. For example, as shown in
The collar 110 may function to attach the nasal spray guide to a nasal spray device, and/or function as a standoff to help determine the axial location of the nasal spray guide along the nasal spray tip and/or depth of permitted nasal spray tip insertion. For example, the height of the collar 110 (in combination with, for example, the thickness of the shoulder 120) may affect the location of the shoulder 120 relative to the nasal spray tip, and thus the depth at which the nasal spray tip may be inserted into a user's nostril.
The collar 110 may have any suitable shape. For example, the nasal spray guide shown in
Furthermore, the lumen 112 defined in the collar 110 may have any suitable shape, such as with a cross-section that is circular, elliptical, etc. Additionally or alternatively, like the collar 110, the lumen 112 may have a substantially constant cross-section along its length passing from one end of the collar 110 to an opposite end of the collar 110 (e.g., as shown in
In some variations, the diameter of the lumen 112 may be adjustable in order to accommodate a variety of nasal spray tips 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 compress to accommodate a range of nasal spray tip sizes and/or shapes. Such conformable material may be located along the entire internal surface of the lumen 112, or along only a portion of the internal surface of the lumen 112 (e.g., conformable rings). As another example of an adjustable lumen 112, the collar 110 may include one or more circumferentially-distributed radially flexing members that are biased inward but flex outward to adjust to receive and clamp around a nasal spray tip 12 therebetween. Such radially flexing members may, for example, be circumferential or arcuate flexing members extending laterally around the lumen (e.g., spiral-like arms), or longitudinal flexing members extending axially along the lumen.
Although a close fit between the lumen 112 and the nasal spray tip 12 received in the nasal spray guide 100 may help retain the nasal spray guide onto the nasal spray device 10 as described above, additionally or alternatively the nasal spray guide 100 may include one or more engagement features to help couple the nasal spray guide to the nasal spray device 10. For example, the nasal spray device 10 may 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 such as the nasal spray tip 12 or pump actuation surface 14). As another example, the nasal spray device 10 may fit over the nasal spray tip (e.g., in a slip fit) and be axially retained in place with an arcuate clip (e.g., C-shaped clip) placed over or adjacent to the nasal spray device 10. As another example, a frictional surface (e.g., textured surface, elastomer lining or gasket) on the internal surface of the lumen 112 may help engage and/or retain the nasal spray guide over the nasal spray tip.
In some variations, the collar 110 may include a singular, ring-like piece defining a lumen therethrough. However, the collar 110 may alternatively include multiple collar portions that may be adjustable to form a lumen. For example, as shown in
As described above, the shoulder 120 may function as a depth limiter and/or a guide for positioning the nasal spray tip relative to a user's nostril. The shoulder 120 may be integrally formed with the collar 110, or the shoulder 120 may be separately formed from and subsequently coupled to the collar 110 (e.g., with one or more fasteners, epoxy, mechanical interfit features, etc.). The shoulder 120 may include a shoulder surface 122 that is configured to contact the nose of the user and may be angled relative to the lumen 112 of the collar 110. In some variations, the shoulder surface 122 may be obliquely angled relative to the lumen 112, such as to help guide 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 shown in
Furthermore, although the shoulder surface 122 is generally shown in
The shoulder surface 122 that is configured to be seated against or abut the user's nose may have any suitable overall shape. For example, as shown in
Additionally, as described above, the shoulder surface 122 may be configured to at least partially surround the lumen 112 through which a nasal spray tip is inserted. In some variations, the lumen may be completely surrounded by the shoulder surface 122 (e.g.,
As the shoulder surface 122 is configured to be seated against the nose of a user, the shoulder surface 122 may, in some variations, include one or more features to help maintain placement of the shoulder surface 122 against skin. For example, the shoulder surface 122 may include textural features (e.g., rim, ridges, channels, detents, raised dots, etc.) and/or a material that is conformable and/or frictional (e.g., silicone). Additionally or alternatively, the shoulder surface 122 may include one or more features to help improve user comfort when the shoulder surface 122 is placed against skin (e.g., conformable material, radiused edges, etc.).
In some variations, the nasal spray guide 100 may include a cap 150 that functions to cover or otherwise enclose the nasal spray tip, such as 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 such that the cavity 152 and the lumen 112 are substantially aligned. As shown and described in further detail below, when the cap and the shoulder are engaged in such a 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 a closed end of the cap. For example, as shown in
In some variations, the cavity 152 of the cap may have an open end that is at least partially surrounded by a cap surface 154 configured to abut the shoulder surface 122 when the cap 150 is placed over the nasal spray tip. As such, the cap surface 154 may be angled relative to the lumen 112 in a manner similar to the shoulder surface 122, and/or otherwise may 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. Furthermore, 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 mechanical interfit features (e.g., snap-fit features) to help rotationally and/or laterally align the cavity 152 and 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 material to help rotationally and/or laterally align the cavity 152 and lumen 112, and/or releasably engage the cap 150 and the shoulder 120 together. The cap 150 may be configured to engage the shoulder 120 in an axial motion (e.g., up and down motion), or may engage via threaded features and/or other suitable separate fasteners.
As shown in
As shown in
In some variations, the cap 150 may include one or more anti-infective substances or other features (e.g., anti-microbial, anti-fungal, etc.) to help reduce growth of pathogens on the nasal spray tip between uses. For example, the cap 150 may be impregnated with an anti-microbial material such as silver. As another example, the cap 150 may include an ultraviolet light source (e.g., UV-C) to selectively sanitize the nasal spray tip when the nasal spray tip is inserted in the cavity 152.
In some variations, the cap 150 may be separate from the rest of the nasal spray guide 100, as shown in
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, arcuate shape, or other suitable shape biased toward leaving the nasal spray tip uncovered). 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 or other suitable shape biased toward leaving the nasal spray tip covered). In yet other variations, the tether may lack a bias toward any particular predetermined shape. For example, the tether may include a freely-movable string-like member, or may include a shapeable wire member that substantially retains the shape or form in which it is placed as the cap and tether are manipulated.
Although the nasal spray guide 100 is primarily described herein as including a cap 150, in some variations, the nasal spray guide 100 may omit a cap 150. For example, the nasal spray guide 100 may be configured for limited use (e.g., single use for one nostril, or two uses for left and right nostrils) and disposed after the limited use.
In some variations, the nasal spray guide may be intended to be oriented in a predetermined orientation relative to an anatomical landmark of the user. For example, the nasal spray guide may be intended to be oriented such that the angled shoulder surface (e.g., shoulder surface 122) helps position the nasal spray tip toward certain anatomy of the user's nose. In these variations, the nasal spray guide may include one or more alignment indicators 130 (e.g., as shown in
In one example variation, the nasal spray guide may be intended to be oriented such that an obliquely angled shoulder surface is angled away from a septum of the user, as shown in
Some or all of the features of the nasal spray guide described herein may include a biocompatible rigid or semi-rigid material (e.g., suitable plastic) such that it sufficiently retains its outer shape and form to ensure its shoulder provides a suitable abutting surface to function as a depth limiter. The nasal spray guide 100 may, in some variations, be formed in 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 constructed from a thermoplastic polymer that has a soft “rubber feel” and retains its shape at room temperature. In some variations, the thermoplastic polymer may comprise a styrene, an ethylene, a 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 comprise a antimicrobial agent, by way of example Withstand™ (Avient) to prevent accumulation of microbes.
To use the nasal spray guide, a user may position at least a portion of the nasal spray device (e.g., nasal spray tip 12) through the lumen 112 of the collar 110, such that the collar 110 is seated on the nasal spray device with a spray outlet end of the nasal spray tip 12 exposed outside of the collar. The user may insert the nasal spray tip 12 in their nostril, until the shoulder 120 of the nasal spray guide is seated against a nasal surface (e.g., nasal base) of the user, thereby guiding an appropriate insertion depth for the nasal spray tip 12. A user may align an alignment indicator on the nasal spray guide with an anatomical landmark and/or the angle of the shoulder 120 may help guide the orientation of the nasal spray tip toward a predetermined orientation, thereby causing the nasal spray tip to target an intended tissue location (e.g., lateral turbinate). For example, in an example variation the nasal spray guide may include an alignment indicator that the user orients toward their septum, and the user may aim the outlet of the nasal spray tip toward their lateral turbinate. Once the nasal spray device is positioned at the appropriate depth and/or angle, the user may actuate the nasal spray device to administer fluid from the nasal spray device. The same procedure may be repeated on the opposite side in the opposite nostril if needed. Following administration of the fluid, the user may disinfect the nasal spray tip if desired (e.g., with an alcohol wipe) and cover the nasal spray tip with the cap 150 of the nasal spray guide. Alternatively, the nasal spray guide may be removed from the nasal spray device and discarded.
The collar 710 may be configured to be placed around the nasal spray tip of a nasal spray device, such as above an actuatable pump of the nasal spray device. The collar 710 may 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 may have other suitable cross-sectional shapes. The lumen 712 may include one or more circumferentially-distributed projections 714 that extend radially inward. As shown in
As shown in
As shown in
The nasal spray guide 700 may further include a cap 750 with a cavity 752. The cap 750 and/or cavity 752 may have a stepped profile, with two or more tiers of progressively narrowing diameter terminating in a closed cap end. Furthermore, the cap 750 may include one or more gripping tabs 756 that provide an outwardly extending surface that a user may contact to manipulate the cap 750. For example, the cap 750 may include one gripping tab 756, two gripping tabs 756 on opposing sides of the cap 750, or more gripping tabs. An open end of the cap 752 may have a surface that is similarly angled at angle θ, so as to form a substantial seal when placed against the elliptical surface of the shoulder 720 (
As shown in
As best shown in
Use of the nasal spray guide 700 is substantially similar to that described above for nasal spray guide 100. For example,
Whereas nasal spray guide 900 as shown in
In certain variations, the nasal spray guide may be configured so that, when placed over the nozzle of a nasal spray pump, the nasal spray guide does not inhibit the spray nozzle orifice, or influence the spray functionality of the pump, for example pump delivery, spray pattern, droplet size distribution, and plume geometry. Spray characterization studies were conducted to study the effect of an embodiment of the nasal spray guide on 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 plume geometry (PG). As shown in
The pump delivery (PD) was measures as milligrams (mg) of the therapeutic composition ejected out of the nasal spray per actuation event. The results of the comparison are shown in Table 1 (n=10 for each condition). As shown in the table, there was no substantive difference in PD between nasal sprays with and without the nasal spray guide.
The actuation force (AF) was measures as kilograms (kg) of force generated by the nasal spray 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 substantive difference in AF between nasal sprays with and without the nasal spray guide.
The spray pattern (SP) was measures as Dmax (diameter of largest drop in spray), ovality, and shape of the spray generated by the nasal spray per actuation event. The results of the comparison are shown in Table 3 (n=10 for each condition). As shown in the table, there was no substantive difference in SP between nasal sprays with and without the nasal spray guide.
The droplet size distribution (DSD) generated by the nasal spray per actuation event was also compared. The results of the comparison are shown in Table 4 (n=10 for each condition). The mean Dv values provide a measure of the DSD of the spray particles. “Mean Dv10” refers to spray particle diameter that is greater than 10% of all the spray particles in an actuation event. “Mean Dv50” refers to spray particle diameter that is greater than 50% of all the spray particles in an actuation event. “Mean Dv90” refers to spray particle diameter that is greater than 90% of all the spray particles in an actuation event. As shown in the table, there was no substantive difference in DSD between nasal sprays with and without the nasal spray guide.
The plume geometry (PG) of the plume generated by the nasal spray per 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 substantive difference in PG between nasal sprays with and without the nasal spray guide.
The foregoing description, for purposes of explanation, used specific nomenclature to provide a thorough understanding of the invention. However, it will be apparent to one skilled in the art that specific details are not required in order to practice the invention. Thus, the foregoing descriptions of specific embodiments of the invention are presented for purposes of illustration and description. They are not intended to be exhaustive or to limit the invention to the precise forms disclosed; obviously, many modifications and variations are possible in view of the above teachings. The embodiments were chosen and described in order to explain the principles of the invention and its practical applications, they thereby enable 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 following claims and their equivalents define the scope of the invention.
