Nasal spray / spout nozzle and nasal rest article for nasal administration

Abstract

Provided is a nasal spray injection nozzle capable of further improving drug delivery to a target site within a nasal cavity. This nasal spray injection nozzle has: a distal end portion having a nozzle injection hole; and a nose rest that can be brought into contact with a portion around a nostril.

Description

Nasal spray / spray nozzles and nasal rests

[0001] The present invention relates to a nasal spray nozzle for administering medicine into the nasal cavity, and also to a nasal rest product.

[0002] As a means of administering medicines, a method of filling a spray / spray device with a liquid medicine and spraying or spraying it onto the mucous membranes and skin on the internal cavity and body surface has been widely used, and intranasal administration of medicines is particularly widely used.

[0003] The advantages of drugs administered by spraying or spraying onto the mucosa, especially intranasal administration, include: (1) rapid absorption leading to the expectation of immediate effect; (2) avoidance of drug degradation due to first-pass liver; (3) avoidance of drug degradation in the digestive tract by gastric acid and digestive enzymes; (4) high bioavailability allowing for lower drug doses; (5) a non-invasive administration route compared to injection; (6) the ability to self-medicate; (7) the ability to deliver drugs directly to the blood circulation or central nervous system; and (8) the nasal mucosa has a specific immune defense mechanism based on a non-specific defense mechanism, making it a potential nasal vaccine.

[0004] Patent No. 6322844 Patent No. 5185109

[0005] Intranasal drugs are primarily sprayed into respiratory areas (e.g., nasal turbinates) to achieve local effects, such as in the treatment of rhinitis. Intranasal drugs have also been used to deliver drugs to the nasopharynx-associated lymphoid tissue, which has a stronger immune response, and to the olfactory area (e.g., olfactory mucosa) for central drug delivery.

[0006] A nasal spray / injection device includes a container containing a medicine, a spray / injection nozzle, and a mechanism (e.g., an actuator) for delivering a metered dose from the container via the nozzle. Nasal spray / injection devices include syringe-type spray / injection devices and airless-type spray / injection devices, in addition to conventional nasal sprays that have been widely used up to now.

[0007] For example, a syringe-type spray / spray device using a nasal spray / spray nozzle that has an optimized spray / spray nozzle shape to improve the uniformity of spray / spray density has been disclosed (see Patent Document 1). Also, an upward pressure airless spray / spray device that can control the administration angle within a desired range has been disclosed (see Patent Document 2).

[0008] The present inventors have found that there is room for further improvement in spray / spray devices in terms of drug delivery to the intended area. More specifically, they have found that the drug delivery characteristics to the target area in the nasal cavity can be further improved when spraying / spraying a drug using a nasal spray / spray nozzle.

[0009] The present invention has been made in view of the above circumstances, and a primary object of the present invention is to provide a nasal spray / injection nozzle that can further improve the delivery of a drug to a target site in the nasal cavity.

[0010] The inventors of the present application attempted to solve the above problems by taking a new approach rather than simply extending the conventional technology, and as a result, they came up with the invention of a nasal spray / injection nozzle that achieves the above-mentioned main object.

[0011] The present invention provides a nasal spray / injection nozzle having a tip end formed with a nozzle ejection hole and a nose rest that can come into contact with the periphery of the external nostril.

[0012] The nasal spray nozzle according to the present invention can further improve the delivery of the drug to the target site in the nasal cavity. Note that the effects described in this specification are merely examples and are not limiting, and additional effects may also be provided.

[0013] 1A to 1C are schematic side views showing various embodiments of a nasal spray / spray nozzle according to the present invention. FIGS. 2A to 2D are schematic top views showing various embodiments of a nose rest in a nasal spray / spray nozzle according to the present invention. FIGS. 3A to 3D are schematic top views showing various embodiments of a nose rest in a nasal spray / spray nozzle according to the present invention. FIGS. 4A to 4C are schematic views showing one embodiment of a nasal spray / spray nozzle according to the present invention (FIG. 4A: perspective view, FIG. 4B: side view, FIG. 4C: top view). FIGS. 5A to 5C are schematic views showing one embodiment of a nasal spray / spray nozzle according to the present invention (FIG. 5A: perspective view, FIG. 5B: side view, FIG. 5C: top view). FIGS. 6A to 6C are schematic views showing one embodiment of a nasal spray / spray nozzle according to the present invention (FIG. 6A: perspective view, FIG. 6B: side view, FIG. 6C: top view). 7A to 7C are schematic diagrams showing one embodiment of a nasal spray / spray nozzle according to the present invention (FIG. 7A: perspective view, FIG. 7B: side view, FIG. 7C: top view). FIGS. 8A to 8C are schematic diagrams showing one embodiment of a nasal spray / spray nozzle according to the present invention (FIG. 8A: perspective view, FIG. 8B: side view, FIG. 8C: top view). FIGS. 9A to 9C are schematic diagrams showing one embodiment of a nasal spray / spray nozzle according to the present invention (FIG. 9A: perspective view, FIG. 9B: side view, FIG. 9C: top view). FIGS. 10A to 10C are schematic diagrams showing one embodiment of a nasal spray / spray nozzle according to the present invention (FIG. 10A: perspective view, FIG. 10B: side view, FIG. 10C: top view). FIG. 11 is a schematic diagram showing one embodiment of a nasal spray / spray nozzle according to the present invention. Figures 12A to 12C are schematic diagrams showing one embodiment of a nasal spray / spray nozzle according to the present invention (Figure 12A: perspective view, Figure 12B: side view, Figure 12C: top view). Figures 13A to 13C are schematic diagrams showing one embodiment of a nasal spray / spray nozzle according to the present invention (Figure 13A: perspective view, Figure 13B: side view, Figure 13C: top view). These are schematic diagrams for explaining that the target area to be sprayed or sprayed by the nasal spray / spray nozzle can be set to a desired area depending on the relationship between the "thin or thick portion" of the nose rest and the "rest contact area around the nostril" with which it abuts. Figures 15A to 15C are schematic side views showing one embodiment of a nasal spray / spray nozzle according to the present invention.16A to 16C are schematic diagrams showing one embodiment of a nasal spray / spray nozzle according to the present invention (FIG. 16A: perspective view, FIG. 16B: side view, FIG. 16C: top view). FIG. 17 is a schematic diagram showing an embodiment of a nasal spray / spray nozzle according to the present invention. FIG. 18 is a top view of a nasal spray / spray nozzle showing an eccentrically installed nose rest (FIG. 18A: circular nose rest in plan view, FIG. 18B: approximately trapezoidal nose rest in plan view, FIG. 18C: approximately gourd-shaped nose rest in plan view, FIG. 18D: approximately bean-shaped nose rest in plan view). FIG. 19 is a top view of a nasal spray / spray nozzle showing a non-encircling embodiment of the outer contour of the tip (FIG. 19A: circular nose rest in plan view, FIG. 19B: approximately trapezoidal nose rest in plan view, FIG. 19C: approximately gourd-shaped nose rest in plan view, FIG. 19D: approximately bean-shaped nose rest in plan view). Figure 20 is a top view of a nasal spray / injection nozzle showing the arc-shaped outer contour of the nose rest (Figure 20A: A nose rest that is elliptical in plan view and has an arc-shaped overall shape; Figure 20B: A nose rest that is roughly gourd-shaped in plan view and has an arc-shaped portion; Figure 20C: A nose rest that is roughly bean-shaped in plan view and has an arc-shaped portion). Fig. 21 is a top view of a nasal spray / spray nozzle according to a combination of an "eccentrically mounted nose rest" and an "arcuate nose rest" (Fig. 21A: a nose rest base that is roughly gourd-shaped in plan view, Fig. 21B: a nose rest base that is roughly bean-shaped in plan view). Fig. 22 is a schematic perspective view showing how the eccentrically mounted nose rest is used (Fig. 22A: the upper side of the wide portion of the nose rest, Fig. 22B: the lower side of the wide portion of the nose rest). Fig. 23 is a schematic view showing a dome-shaped nose rest (Fig. 23A: top view, 23B: a side view viewed from direction A, 23C: a side view viewed from direction B). Fig. 24 is a schematic perspective view of one embodiment of a nasal spray / spray nozzle according to the present invention. Fig. 25 is a schematic perspective view of an eccentrically mounted nose rest according to one embodiment. Figure 26 is a schematic diagram showing a nose rest according to one embodiment (Figure 26A: top view, Figure 26B: cross-section taken along II). Figures 27A-27G are schematic top views showing various embodiments of a finger rest according to the present invention. Figure 28 is a schematic cross-section of an upward pressure airless spray device equipped with a nasal spray / spray nozzle according to the present invention.The right half of the drawing shows a cross-sectional view so that the internal structure can be seen. Fig. 29 is an enlarged cross-sectional view of the essential parts of the upward pressure exhaust airless spray / spray device shown in Fig. 28. It is a schematic diagram illustrating that spraying / spraying is possible at any administration angle. Fig. 31 is a cross-sectional view showing the schematic configuration of a syringe-type spray / spray device equipped with a nasal spray / spray nozzle according to the present invention. Figs. 32A and 32B are exploded perspective views showing the schematic configuration of a nasal spray / spray nozzle according to one embodiment of the present invention, showing the state before and after the filling rod is inserted into the nozzle body. Fig. 33A is a vertical cross-sectional view of the nasal spray / spray nozzle shown in Fig. 32B when viewed on a vertical plane, and Figs. 33B to 33D are horizontal cross-sectional views taken along lines B-B, C-C, and D-D of Fig. 33A, respectively. 34A to 34C are schematic diagrams showing one embodiment of a syringe-type spray / spray device using a nasal spray / spray nozzle according to the present invention (FIG. 34A: perspective view, FIG. 34B: side view, FIG. 34C: top view). 35A to 35C are schematic diagrams showing one embodiment of a syringe-type spray / spray device using a nasal spray / spray nozzle according to the present invention (FIG. 35A: perspective view, FIG. 35B: side view, FIG. 35C: top view). 36A to 36B are schematic diagrams for explaining one embodiment of a nasal rest product according to the present invention (FIG. 36A: perspective view, FIG. 36B: top view). 37 is a schematic perspective view showing the insertion of a nasal spray / spray nozzle according to the present invention into a human nasal cavity for administration. 38 is a schematic diagram showing the insertion of a nasal spray / spray nozzle according to the present invention into a human nasal cavity for administration, viewed from the direction of the opening of the external nostril. Fig. 39 is a schematic cross-sectional view showing the state of inserting the nasal spray / spray nozzle of the present invention into a human nasal cavity and administering the medicine. Fig. 40 is a schematic diagram showing the spray angle of the medicine sprayed or sprayed from the nozzle orifice. Fig. 41 is a schematic diagram showing a modified nose rest (Fig. 41A: top view, Fig. 41B: side view). Fig. 42 is a schematic diagram showing a modified nose rest (Fig. 42A: top view, Fig. 42B: side view).Fig. 43 is an image showing the nasal spray / spray nozzle used in the comparative examples (Fig. 43A: Comparative Example 1, Fig. 43B: Comparative Example 2, Fig. 43C: Comparative Example 3). Fig. 44 is an image showing the nasal spray / spray nozzle used in the examples (Fig. 44A: Example 1, Fig. 44B: Example 2, Fig. 44C: Example 3). Fig. 45 is an image showing the nasal cavity model used in the demonstration test. Fig. 46 is a schematic diagram showing the nozzle position and angle in the demonstration test (Fig. 46A: angle α, Fig. 46B: angle β). Fig. 47 is a schematic cross-sectional view of a human nasal cavity.

[0014] [Findings and other information that form the basis of the present disclosure] Conventional spray / spray devices may not be suitable for various complex intranasal structures. For example, the narrow nasal cavity area around the nasal valve may trap the drug, preventing sufficient drug delivery to the target area (see FIG. 47). The term "target area" as used here refers to the area that is sprayed or sprayed by the nasal spray / spray nozzle (e.g., at least the area within the nasal cavity, such as the respiratory portion of the nasal mucosa, the nasopharynx, or the olfactory area).

[0015] For example, if the spray / spray nozzle of a nasal spray / spray device is inserted too shallowly, the sprayed medicine may be trapped by the nasal valve, etc. On the other hand, if the spray / spray nozzle is inserted too deeply, the spray angle of the medicine relative to the target area may become narrow, and the medicine may not be delivered to a wide area of ​​the target area.

[0016] Therefore, the present inventors have come to consider a more optimized configuration of a nasal spray / injection nozzle that can be applied to the complex structure of the nasal cavity.

[0017] Hereinafter, with reference to the accompanying drawings, embodiments for carrying out the invention according to the present disclosure will be described. The described embodiments are intended to embody the technical concept of the invention according to the present disclosure, and unless otherwise specified, the invention according to the present disclosure is not limited to those described below. In each drawing, components having the same function may be designated by the same reference numeral. For convenience, the embodiments may be shown separately in consideration of ease of explanation or understanding of the main points, but partial substitution or combination of configurations shown in different embodiments is possible. Furthermore, in the embodiments described below, descriptions of matters common to the above will be omitted, and only differences will be described. In particular, similar effects due to similar configurations will not be mentioned sequentially in each embodiment. The size and positional relationship of components shown in each drawing may be exaggerated for clarity.

[0018] In the description of the embodiments, terms indicating directions (such as "up-down direction," "horizontal direction (left-right direction)," "depth direction," "proximal side," and "distal side") are used as appropriate to facilitate understanding, but these terms are for the purpose of explanation and do not limit the present invention. Furthermore, in each of the accompanying drawings, similar components are illustrated using similar reference numerals.

[0019] The terms "up-down direction," "horizontal direction (left-right direction)," and "depth direction" used in this specification correspond to the up-down direction, horizontal direction, and depth direction in the drawings, respectively. For example, the "up-down direction" may be understood as meaning that the vertical downward direction (i.e., the direction in which gravity acts) corresponds to the "downward direction," and the opposite direction corresponds to the "upward direction."

[0020] The term "side view" as used herein refers to the shape of the nasal spray / spray nozzle as viewed from a direction substantially perpendicular to the longitudinal direction of the nozzle (e.g., the shapes shown in Figures 1A to 1C, etc.), i.e., the shape of the nozzle as viewed from the outside in a direction substantially perpendicular to the axial direction of the nasal spray / spray nozzle.

[0021] The term "top view" as used herein refers to the shape of the nasal spray / spray nozzle as viewed from the nozzle orifice side (e.g., the shapes shown in Figures 2A to 2D, etc.), i.e., the shape of the nasal spray / spray nozzle as viewed from the outside along the axial direction of the nasal spray / spray nozzle (e.g., the nozzle orifice side).

[0022] As used herein, "substantially" refers to a state that is close to, but not entirely or completely. For example, a "substantially elliptical shape" is not necessarily limited to shapes that a person skilled in the art would recognize as ellipses in the strict sense, but also includes shapes that can be recognized as ellipses, even if they are not strictly elliptical. For example, even if a part of the elliptical outline is the outline of another shape, it also includes shapes that a person skilled in the art would recognize as an ellipse.

[0023] In this specification, "diameter" may refer to the diameter of a circle, ellipse, inscribed circle, or inscribed ellipse in the shape of an object when viewed from above. Here, "inscribed circle" or "inscribed ellipse" refers to the circle or ellipse with the largest area inside a polygon. If multiple such diameters are possible, this refers to the largest diameter among them.

[0024] In the illustrated example, the "diameter" is the diameter D １ (See Figure 2A) and if the object is an ellipse, the major axis D １ (See Figure 2B) If the object is a square, the diameter of its inscribed circle is D １ (See Figure 2C) or, if the object is a rectangle, the major axis D of the inscribed ellipse. １ (See FIG. 2D).

[0025] [Features of the nasal spray / spray nozzle according to the present invention]

[0026] The nasal spray / spray nozzle of the present invention is a nozzle product capable of ejecting a fluid substance to the outside. In particular, the nasal spray / spray nozzle of the present invention is a nozzle product capable of ejecting a fluid substance, such as a medicine, preferably in the form of a spray and / or a spray.

[0027] The nasal spray / spray nozzle according to the present invention comprises a tip end portion having an ejection hole formed therein and a nose rest that can abut against the periphery of the nostril. In the exemplary embodiment shown in Figures 1A to 1C, the nasal spray / spray nozzle 10 comprises a tip end portion 11 having a nozzle ejection hole 11A formed therein and a nose rest 12.

[0028] The nasal spray / spray nozzle according to the present invention is not particularly limited, and may be made of, for example, a resin material, a glass material, a metal material, a ceramic material, etc. In a preferred example, the nasal spray / spray nozzle is a resin product (e.g., a resin molded product).

[0029] The nasal spray / spray nozzle according to the present invention may have a hollow portion inside or within itself. For example, a hollow portion is formed inside or within the tip 11 of the nasal spray / spray nozzle 10 according to the present invention. Such a hollow portion is preferably in communication with the nozzle orifice. Furthermore, the hollow portion inside or within such a nasal spray / spray nozzle may be in communication with the outside on the side opposite the nozzle orifice. In other words, the end of the nasal spray / spray nozzle that faces the nozzle orifice in the axial direction may have an open end.

[0030] 1A, for example, the tip portion 11 and nose rest 12 are connected so as to be adjacent to each other in the axial direction of the nasal spray / spray nozzle 10. Here, the "axis" refers to an imaginary line that passes through the central portion of the nasal spray / spray nozzle in the longitudinal direction.

[0031] The nasal spray / spray nozzle 10 comprises, from its proximal side (i.e., the side located relatively close to the nose during use), a tip portion 11 equipped with a nozzle orifice, a nose rest 12, and a nozzle body 13, arranged in this order. These may be members having a hollow portion inside. For example, the tip portion 11 may be a member having a hollow portion inside, with a closed end equipped with a nozzle orifice and an opposing open end. The nozzle body 13 may be a member having a hollow portion inside, with both ends having opposing open ends. The nose rest 12 may be a member having, for example, an overall ring shape or a partially cut-out ring shape with a hollow portion inside.

[0032] The tip portion 11 having the nozzle orifice, the nose rest 12, and the nozzle body 13 may be integral with one another to form the nasal spray / injection nozzle 10 (see FIG. 1A, etc.). As can be seen from the illustrated form, the nose rest 12 may be considered as a portion or member added to the periphery of the tip portion 11 and / or the body 13. Alternatively, the tip portion 11 and the body 13 may be considered as an integral single member (e.g., a cylindrical member having a hollow interior), and the nose rest 12 may be considered to be provided on that member (e.g., the nose rest 12 may be considered as a protrusion provided on the outer circumferential surface of such an integrated member).

[0033] In nasal spray / spray nozzle 10, tip 11 is provided to extend from nose rest 12 in the axial direction of nasal spray / spray nozzle 10 (see FIG. 1A, etc.). Nose rest 12 extends or protrudes outward from the axial direction of nasal spray / spray nozzle 10 (see FIG. 4, etc.). Here, "outward" corresponds to, for example, a radial direction that is approximately perpendicular to the axial direction of nasal spray / spray nozzle 10.

[0034] At least a portion of the nose rest 12 can abut the periphery of the nostril. This allows for more optimal stabilization of the nasal spray / spray nozzle during use, thereby improving the delivery of the drug to the target site in the nasal cavity. For example, the nasal spray / spray nozzle of the present invention can further improve the rate at which the drug reaches the target site. Without being bound by any particular theory, it is believed that this improvement in drug delivery is due to more optimal fixation or stabilization of the nozzle orientation (e.g., the angle formed between the nozzle and a plane parallel or perpendicular to the nasal septum) and / or the insertion length of the nozzle tip into the nasal cavity during use.

[0035] In a preferred embodiment, the nose rest 12 limits the portion of the nasal spray / spray nozzle 10 inserted into the nasal cavity, preferably to approximately the tip 11. In other words, the length of the nasal spray / spray nozzle 10 inserted into the nasal cavity can be approximately the length dimension L of the tip 11. That is, the nozzle orifice 11A can be appropriately positioned within the nasal cavity. This also means that the insertion depth of the nozzle orifice within the nasal cavity is appropriate. Therefore, by using a nasal spray / spray nozzle, medication can be appropriately delivered to a target area, even in cases with complex nasal structures. For example, by abutting at least a portion of the nose rest against the periphery of the external nostril, the insertion position of the nozzle orifice within the nasal cavity can be more appropriately determined. Therefore, medication can be delivered without being inserted too shallowly or too deeply, making it easier to deliver the medication to a wide range of the target area.

[0036] As used herein, a "nozzle" is a device for determining the direction of a liquid, preferably the flow direction of a medicine (e.g., a liquid or gel), and for discharging (spraying or spraying) a liquid such as medicine from a hole provided at its tip. Therefore, the nozzle preferably has a hollow portion therein that communicates with the tip hole (this hollow portion may also communicate with the nozzle opening). The nozzle may also be referred to as a "spout," a "member for spraying / spraying medicine," or a "member for spraying / spraying supply."

[0037] As used herein, the term "surrounding area of ​​the external nostrils" refers to the parts of the nose that are present around the external nostrils (see Figures 38 and 47 for "external nostrils"). For example, the term "surrounding area of ​​the external nostrils" refers to at least one selected from the group consisting of the tip of the nose, the columella, the ala of the nose, the nasal passages, and the walls of the internal nostrils.

[0038] The term "contact" as used herein refers to contact in a pressing manner. The term "contact" as used herein encompasses at least one aspect selected from the group consisting of, for example, "holding," "sliding," "hooking," and "locking."

[0039] The "tip" in this specification refers to the portion of the nasal spray / spray nozzle that can be inserted into the nasal cavity. The tip 11 is positioned proximally in the nasal spray / spray nozzle 10 and preferably has a diameter smaller than at least the nostril (see FIG. 1A, etc.).

[0040] When viewed from above, the width of the tip 11 of the nasal spray / injection nozzle 10 is, for example, the diameter D ２ (See FIG. 2A) may be 3 mm or more and 10 mm or less. ２ By making the diameter of the tip D 3 mm or more, a sufficient nozzle ejection hole diameter can be ensured. ２ By making the diameter D of the tip portion 11 10 mm or less, when the nasal spray / spray nozzle is inserted into the nasal cavity, it becomes easier to prevent the tip portion 11 from contacting the wall surface of the inner nostril. ２ is preferably 3 mm or more and 9 mm or less, for example, 3 mm or more and 7 mm or less.

[0041] Here, "diameter D ２ " may be considered to be the average diameter at the tip 11 along the axial direction of the nasal spray / injection nozzle 10. For example, it is the average diameter of any three points at the tip 11 along the axial direction.

[0042] The diameter of the surface where nozzle outlet 11A is formed (i.e., the proximal end surface of nasal spray / spray nozzle 10) may be smallest at tip 11, and may be, for example, 3 mm to 10 mm, 3 mm to 9 mm, or 3.5 mm to 8.5 mm. By setting the proximal end surface to these dimensions, it becomes easier to insert the tip into the nasal cavity more smoothly, which can ultimately contribute to improving the drug delivery characteristics.

[0043] When viewed from above, the diameter of the nozzle orifice 11A, for example, the diameter D ３ (see FIG. 2A) may be 0.15 mm or more and 0.60 mm or less. ３ By setting the diameter D of the nozzle ejection hole 11A in the above range, the ejection angle of the medicine becomes more appropriate. ３ is preferably 0.20 mm or more and 0.45 mm or less, for example, 0.25 mm or more and 0.30 mm or less.

[0044] In a side view of the nasal spray / spray nozzle 10, the tip portion 11 has a length dimension L (see FIG. 1A ). Here, "length dimension L" refers to the axial length of the tip portion 11 (i.e., the longitudinal dimension). More specifically, "length dimension L" corresponds to the length from the proximal end of the nose rest 12 to the surface on which the nozzle outlet hole 11A is formed. Explained with reference to FIG. 6A , "length dimension L" is the length L along the axial direction from the forefront of the nasal spray / spray nozzle 10 (i.e., the nozzle end face) to the proximal end 12E of the nose rest 12.

[0045] In a side view of the nasal spray / spray nozzle 10, the length dimension L of the tip 11 along the nozzle axis direction may be 5 mm or more and 30 mm or less (see FIG. 1A, etc.). Having this dimension of 5 mm or more makes it easier to reduce the amount of medicine trapped by the nasal valve, etc. Furthermore, having this dimension of 30 mm or less allows for a wider spray angle of the medicine relative to the target area, enabling the medicine to be delivered over a wider area of ​​the target area. The length dimension of the tip is preferably 7 mm or more and 25 mm or less, for example, 10 mm or more and 25 mm or less, 7 mm or more and 18 mm or less, 8 mm or more and 17 mm or less, 9 mm or more and 16 mm or less, or 10 mm or more and 15 mm or less.

[0046] The tip portion may have any shape that allows insertion into the nasal cavity. For example, the tip portion may be generally cylindrical or may have a generally conical shape tapering toward its proximal end (i.e., a generally conical shape tapering toward the nozzle orifice). The proximal end of the tip portion may be rounded to reduce pain caused by contact with the wall of the inner nostril. In other words, the proximal end of the tip portion may have a chamfered shape.

[0047] As used herein, the term "nose rest" refers to a component of a nasal spray / spray nozzle that includes a portion that abuts against the periphery of the nostril (more specifically, a component that includes a portion that abuts against the periphery of the nostril when the nasal spray / spray nozzle is inserted tip-first into the nostril). The nose rest of the present invention is a component that protrudes or extends outward so that at least a portion of it can abut against the periphery of the nostril. The nose rest may also be referred to as a "nasal insertion stopper." Preferably, the nose rest is a nozzle portion or component that abuts against the periphery of the nostril to prevent the nasal spray / spray nozzle from being inserted further into the nasal cavity.

[0048] The nose rest 12 is positioned distally relative to the tip 11 in the nasal spray / spray nozzle 10 (see FIG. 1A , etc.). That is, the nose rest 12 is located farther from the nostrils during use than the tip 11 in the nasal spray / spray nozzle. More specifically, as shown in the figure, the nose rest 12 may be located adjacent to the tip 11 on the distal side of the tip 11 or directly or indirectly connected to the tip 11. The nose rest may be a part or member integrated with the tip of the nasal spray / spray nozzle, or may be a separate member or component attached to the nasal spray / spray nozzle. When the tip and the nose rest are integrated with each other, they may be made of the same material or different materials.

[0049] The nose rest 12 may have any shape as long as at least a portion thereof can abut against the periphery of the nostril. That is, any shape may be used as long as the nose rest 12 presses against the periphery of the nostril when the nasal spray / spray nozzle 10 is inserted, thereby preventing further insertion of the nasal spray / spray nozzle 10. In a preferred embodiment, only a portion of the nose rest may be configured to press against the periphery of the nostril. That is, the nose rest may protrude or extend outward so that only a portion of the nose rest can abut against the periphery of the nostril. By having only a portion of the nose rest press against the periphery of the nostril, further insertion of the nasal spray / spray nozzle 10 is prevented, while the orientation and / or angle of the nasal spray / spray nozzle 10 can be easily and suitably adjusted.

[0050] In one embodiment, when viewed from above, the outer contour of nose rest 12 may surround at least a portion of the outer contour of tip portion 11. For example, when viewed from above, the contour, particularly the outer contour, of nose rest 12 is positioned so as to surround the contour, particularly the outer contour, of tip portion 11 (see FIGS. 1A, 2A-2D, and 3A-3D). For example, in nasal spray / spray nozzle 10, nose rest 12 may extend outward in a generally brim-like or flange-like manner.

[0051] The above-described configuration increases the contact area between at least a portion of the nose rest and the area surrounding the nostril during use, allowing the nasal spray nozzle to be pressed firmly against the nostril, thereby more appropriately determining the insertion position of the nozzle outlet.

[0052] In a top view of the nasal spray / spray nozzle 10, the nose rest 12 may be generally circular, elliptical, polygonal, or chamfered polygonal, or may have a shape with a portion cut out from any of these shapes, or may have such a shape with the nozzle positioned off-center. See Figures 2A-2D and 3A-3D. In other words, the nose rest (in a perspective view and / or side view of the nasal spray / spray nozzle) may have a generally flat, disk-like, dome-like, conical, elliptical-conical, or other irregular shape.

[0053] In one embodiment, the nose rest 12 may have a generally elliptical shape when viewed from above the nasal spray / spray nozzle 10 (see FIG. 2B ). That is, when viewed from above the nasal spray / spray nozzle 10, the nose rest 12 has a shape that protrudes in two opposing directions. For example, the nose rest may be generally dome-shaped or generally elliptical cone-shaped.

[0054] The above-described configuration makes it easier for the nose rest to conform to the shape of the periphery of the nostril, thereby improving contact with the periphery of the nostril and the ease of handling of the nasal spray / injection nozzle.

[0055] When viewed from above, the width of the nose rest 12 of the nasal spray / injection nozzle 10 is, for example, the diameter D １ The diameter D of the nose rest 12 (see Figs. 2A to 2D) may be 10 mm or more and 50 mm or less. When the diameter is 10 mm or more, it is easier to improve the contact with the external nostril. Also, when the diameter is 50 mm or less, it is easier to improve the handling of the nasal spray / injection nozzle 10. １ may be 12 mm or more and 40 mm or less, for example 15 mm or more and 30 mm or less.

[0056] Here, "diameter D １ " may be considered to be the maximum width dimension, for example, the maximum diameter, of the nose rest 12. For example, as described above, it may refer to the diameter of a circle, ellipse, inscribed circle, or inscribed ellipse in the shape of the nose rest 12 when viewed from above.

[0057] Alternatively, the nose rest 12 may have a concave or convex shape, a generally tentacle shape, a generally forceps shape, a generally clip shape, or the like to hook onto the nostrils (see FIGS. 1B and 1C).

[0058] Figures 4 to 17 illustrate various embodiments of the nasal spray / spray nozzle according to the present invention. Specifically, Figures 4 and 5 illustrate nasal spray / spray nozzles for use with syringe-type spray / spray devices. Figures 6 to 13 and 15 to 17 illustrate nasal spray / spray nozzles for use with upward-exhaust airless spray / spray devices.

[0059] In one embodiment, the nose rest 12 may have a portion whose diameter tapers toward the nozzle orifice 11A (see, for example, FIG. 4B ). The nose rest may taper gradually toward the nozzle orifice, or may taper in a stepwise manner. In the example shown in FIG. 4B , the nose rest has at least a portion whose diameter tapers gradually toward the nozzle orifice (e.g., whose overall width gradually decreases). This configuration facilitates a larger contact area between the nose rest and the periphery of the external nostril when the nozzle rest abuts against the periphery. Furthermore, when the nasal spray / spray nozzle 10 is inserted into the nasal cavity, the tapered portion can more easily fit the wall of the internal nostril.

[0060] That is, the reduced diameter portion of nose rest 12 allows nasal spray / spray nozzle 10 to be firmly pressed against the wall of the inner nostril, making it particularly easy to determine the insertion position and direction of nozzle outlet 11A. It also reduces the impact on the wall of the inner nostril when nasal spray / spray nozzle 10 is inserted into the nasal cavity, making it easier to reduce pain and other discomfort experienced by the user, such as a patient.

[0061] In one embodiment, the tip portion may have at least a portion that gradually tapers toward the nozzle orifice. For example, as shown in Figure 6B, the tip portion 11 may have a shape that gradually tapers toward the nozzle orifice 11A. This configuration makes it easier to prevent the tip portion 11 from undesirably contacting the wall of the inner nostril when the nasal spray / spray nozzle 10 is inserted into the nasal cavity.

[0062] The tip portion 11 and the nose rest 12 may decrease (or increase) in diameter in a linear manner, a curved manner, a stepwise manner, or a mixture of linear and curved manners. In the exemplary embodiment shown in Fig. 6, the nose rest 12 may be decreased in diameter to a greater extent (e.g., gradually) than the tip portion 11. From another perspective, the nose rest 12 may form a smaller angle with respect to a plane perpendicular to the axis of the nasal spray / injection nozzle 10 than the tip portion 11.

[0063] In a nasal spray / spray nozzle 10 used in a syringe-type spray / spray device, a syringe connection protrusion 13' may be provided on the nozzle body 13 (see FIG. 4), or may not be provided (see FIG. 5). From the perspective of particularly emphasizing improved handleability, it is preferable that the nasal spray / spray nozzle 10 be provided with a syringe connection protrusion 13'. The diameter of such a syringe connection protrusion 13' is, for example, 5 mm or more and less than 15 mm. As shown in the figure, the syringe connection protrusion 13' may be provided at the lower end of the body of the nasal spray / spray nozzle 10. In other words, the syringe connection protrusion may be provided at the distal end of the nasal spray / spray nozzle.

[0064] In one embodiment, the nose rest 12 may have a generally elliptical shape (see FIG. 7). That is, the nose rest 12 has a generally elliptical shape when viewed from above. This configuration makes it easier for the nose rest 12 to fit around the periphery of the nostrils (particularly the ala, columella, and nasal passages) when the nasal spray / spray nozzle 10 is inserted into the nasal cavity.

[0065] In one embodiment, nose rest 12 may have a generally petal-like shape (see Figures 8 and 9). This configuration allows nose rest 12 to be easily latched onto the ala of the nose on the side of the nasal cavity being inserted and the wall of the inner nostril on the other side of the nasal cavity when nasal spray / injection nozzle 10 is inserted into the nasal cavity.

[0066] In the above-described embodiment, the tip of the petal-shaped nose rest 12 may be curved toward the nozzle outlet 11A (see FIG. 9 ). With such a configuration, when inserting the nasal spray / spray nozzle 10 into a nasal cavity, the nose rest 12 can be more easily hooked onto the ala of the nostril on the side of the nasal cavity into which the nozzle is inserted and onto the wall of the inner nostril on the other side of the nasal cavity.

[0067] In one embodiment, the nose rest 12 and the nozzle body 13 may not have a step (see FIG. 10 ). In other words, the outer surface of the nose rest 12 and the outer surface of the nozzle body 13 may be integrally continuous with each other. In this embodiment, the outer surface of the nose rest 12 and the outer surface of the nozzle body 13 are flush with each other. This configuration can simplify the manufacturing process, for example, when manufacturing a nasal spray / injection nozzle by integral molding.

[0068] In one embodiment, the nose rest 12 may be a detachable member from the nasal spray / spray nozzle 10 (see FIG. 11 ). That is, the nose rest 12 may be detachable from the nasal spray / spray nozzle 10. This configuration allows the nasal spray / spray nozzle 10 and the nose rest 12 to be manufactured in separate processes. Furthermore, the shape of the nose rest can be appropriately customized to fit the individual nose of each user. The detachable nose rest 12 may be made of a resin material. The detachable nose rest 12 and the tip portion 11 may be made of different materials (e.g., different resin materials). In such a case, the nose rest 12 may be made of a material with more cushioning properties (e.g., a soft resin material or an elastomer material).

[0069] In one embodiment, the nose rest may include a relatively steep surface and a relatively non-steep surface. For example, as shown in Figures 12B and 13B, the nose rest 12 may have a portion whose diameter tapers toward the nozzle orifice 11A, and this portion of the taper may include a relatively steep surface and a relatively non-steep surface. In other words, the nose rest may have locally different degrees of inclination of the rest surface.

[0070] In other words, when viewed from the side of the nasal spray / injection nozzle 10, the nose rest 12 has a contour that gradually changes toward the tip 11, and there may be areas where this gradual change is relatively large and areas where it is relatively small (see Figures 12B and 13B).

[0071] In the exemplary embodiment shown in FIGS. 12B and 13B, the nose rest 12 has a relatively steep surface 12S. １ and the relatively gentle surface 12S ２ More specifically, the inclined surface 12S is inclined with respect to a plane (horizontal plane) perpendicular to the axis of the nasal spray / injection nozzle 10. １ is the angle θ １ (i.e., VV′ and W in FIGS. 12B and 13B) １ -W １ ' and the angle θ １ ) and forms an inclined surface 12S with respect to the horizontal plane. ２ is the angle θ １ ' (i.e., V-V' and W ２ -W ２ ' and the angle θ １ '), where the angle θ １ is the angle θ １ ' is bigger than that.

[0072] The inclined surface 12S as described above ２ or 12S １ By bringing the nozzle into contact with the periphery of the nostril, the direction (angle) of the nozzle orifice can be adjusted to various target areas when the nasal spray / spray nozzle is inserted into the nasal cavity. ２ Angle θ with respect to １ ' or inclined surface 12S １ Angle θ with respect to １ may be adjusted (see Figures 12B and 13B).

[0073] Although only an example, the relatively gentle inclined surface 12S as described above may be ２ It may be in contact with the peripheral portion of the nasal passage (i.e., the nasal passage and / or the bridge of the nose and / or the ala of the nose on the nasal passage side), or it may be in contact with the peripheral portion of the nasal protrusion (i.e., the nasal protrusion and / or the bridge of the nose and / or the ala of the nose on the nasal protrusion side) (see Figure 47 for the nasal passage and the nasal protrusion, etc.).

[0074] When the target area to be sprayed or sprayed by the nasal spray nozzle is the respiratory or olfactory area, the angle θ １For example, when the target area is the respiratory area, the inclination angle 12S may be set to be 5° or more and 20° or less. ２ In addition, when the target area is the olfactory region, it is preferable to have the relatively gentle inclined surface 12S abut against the peripheral portion of the food. ２ It is preferable that the protruding portion of the nose be abutted against the periphery of the nose.

[0075] In one embodiment, nose rest 12 may have local thickness variations. For example, nose rest 12 may have relatively thin portions and relatively thin portions due to relatively steep and relatively non-steep slopes. In such cases, it can be said that the thickness of nose rest 12 does not have a point-symmetric relationship when viewed from above nasal spray / injection nozzle 10.

[0076] By abutting the nose rest having the above-described local thickness difference against the peripheral portion of the nostril, the direction (angle) of the nozzle orifice can be adjusted to various target areas when inserting the nasal spray / spray nozzle into the nasal cavity. Here, such thickness difference may be adjusted to adjust the direction of the nozzle orifice to various target areas.

[0077] In other words, when a relatively thin or thick portion of nose rest 12 is brought into contact with the periphery of the nostril, the relationship between the "thin or thick portion" and the "rest contact area around the periphery of the nostril" with which it abuts can facilitate the desired target area for spraying or injecting with the nasal spray / injection nozzle (see Figures 14A-14D, particularly Figures 14B-14D). For example, bringing the relatively thin portion of nose rest 12 into contact with the nasal cavity or its periphery facilitates insertion of the nasal spray / injection nozzle in a more perpendicular direction relative to the horizon. Therefore, the target area for spraying or injecting with the nasal spray / injection nozzle can preferably be the olfactory region. On the other hand, bringing the relatively thick portion of nose rest 12 into contact with the periphery of the nasal cavity or its periphery facilitates insertion of the nasal spray / injection nozzle in a more horizontal direction relative to the horizon. Therefore, the target area for spraying or injecting with the nasal spray / injection nozzle can preferably be the nasopharynx.

[0078] Note that various shapes of nose rest 12 having local thickness variations are conceivable, and may be, for example, the shape shown in Fig. 15. That is, it may be a shape in which a portion of the side view contour of the nose rest shown in Figs. 12 and 13 is removed (more specifically, a shape in which at least a portion of the side view contour of a relatively thick portion is removed). A nose rest such as that shown in Fig. 15 may make it easier to insert the nasal spray / spray nozzle into the nasal cavity, or may make it easier to abut the relatively thin portion of the nose rest against the desired periphery of the external nostril (see Figs. 14C and 14D).

[0079] In one embodiment, the spray direction of the nozzle nozzle orifice 11A is at an angle θ ２ or θ ３ More specifically, the axis X-X' of the nasal spray / injection nozzle 10 and the normal Y-Y' to the plane forming the nozzle orifice 11A (i.e., the spray direction of the nozzle orifice 11A) form an angle θ ２ or θ ３ It is made up of the following.

[0080] The normal Y-Y' to the plane forming the nozzle orifice 11A is formed at an angle θ with respect to the axis XX' of the nasal spray / injection nozzle 10 by curving or bending the tip 11. ２ (See FIGS. 16A and 16B.) The term "curved" or "bent" used here may refer to a shape that is curved or bent in advance, or may refer to a configuration that can be curved or bent as needed during use.

[0081] Alternatively, the normal Y-Y' to the plane forming the nozzle orifice 11A is formed at an angle θ ３ (See FIG. 17).

[0082] Angle θ ２ and θ ３(see FIGS. 16B and 17) may be formed with respect to the direction in which the portion of the nose rest 12 that abuts against the periphery of the nostril (for example, portion 15 in FIG. 16A) faces. ２ and θ ３ 16B and 17. Such a configuration facilitates suitable delivery of the drug to target areas in various intranasal structures.

[0083] In the above-described embodiment, when the target region is the respiratory region or the olfactory region, the angle θ ２ and θ ３ is preferably 5° or more and 15° or less. For example, when the target area is the respiratory region, it is preferable to abut the portion of the nose rest corresponding to the opening direction of the nozzle orifice (e.g., the right direction in FIG. 16B ) against the periphery of the external nostril. Also, when the target area is the olfactory region, it is preferable to abut the portion of the nose rest corresponding to the opposite direction to the opening direction of the nozzle orifice (e.g., the left direction in FIG. 16B ) against the periphery of the external nostril.

[0084] If the target region is the nasopharynx, the angle θ ２ and θ ３ The angle may be 5° or more and 15° or less. Here, it is preferable that the part of the nose rest corresponding to the opening direction of the nozzle ejection holes is brought into contact with the periphery of the external nostril.

[0085] Angle θ ２ and θ ３ (see FIGS. 16B and 17) may be formed with respect to a direction substantially perpendicular to the direction in which the portion of the nose rest 12 that abuts against the periphery of the nostril faces. ２ and θ ３ 16B and 17. This configuration can effectively deliver the medication to the target area in the nasal cavity, and in particular, can effectively prevent the medication from being sprayed toward the nasal septum or ala of the nose.

[0086] In the above-described embodiment, the angle θ ２ and θ ３The angle may be 5° or more and 15° or less. Here, it is preferable that the portion of the nose rest that corresponds to a direction substantially perpendicular to the opening direction of the nozzle orifices (for example, the depth direction in FIG. 16B ) be brought into contact with the periphery of the external nostril.

[0087] To prevent misuse, the nasal spray nozzle may have a conforming surface (particularly a surface that can conform to the periphery of the nostril when the nasal spray nozzle is inserted into the nostril) or an orientation marker. The conforming surface 15 or orientation marker 15 may be provided anywhere on the nasal spray nozzle 10, such as on the nose rest 12 (see FIGS. 13, 16, and 17).

[0088] In one embodiment, the aforementioned conforming surface may be a cutout or a contact plate. In other words, the nose rest may have a cutout or a contact plate for contacting or conforming with the periphery of the nostril.

[0089] The cutout may have any shape as long as it can fit around the periphery of the nostril (e.g., the bridge of the nose, the ala of the nose, and the nasal passages). Such a shape may be, for example, a cutout 15 that matches the shape of the ala of the nose, the bridge of the nose, or the nasal passages (see FIG. 13).

[0090] For example, when the nose rest has a generally elliptical shape in top view, the shape of the nose rest having a cutout may be such that a portion of the outline of the generally elliptical shape is cut out compared to the original shape. In other words, the surface formed by the cutout (e.g., surface 15a in FIG. 13) may include a flat surface and / or a curved surface. For example, the "cutout" may be a "concave portion" or a "U-shaped portion," etc.

[0091] The contact plate may also have any shape that can fit around the nostrils, such as a contact plate 15 that conforms to the shape of the ala, bridge, or nasal passages (see FIG. 16).

[0092] Here, the "contact plate" may have a shape such as a concave or U-shape. The contact plate may be formed such that a part of the outer contour of the nose rest is concave or U-shaped, or a separate member (e.g., an elastomer material) may be attached to the nose rest.

[0093] In one embodiment, the axis of the tip portion 11 and the center of the nose rest 12 may be offset from each other in a top view of the nasal spray / spray nozzle (see FIGS. 18A-18D). That is, the nose rest may be positioned eccentrically relative to the axis of the nasal spray / spray nozzle. The "center" here may be, for example, the center of gravity of the nose rest. The center of such a nose rest may be, for example, a point midway between two width dimensions in mutually perpendicular directions in a top view (see FIGS. 18A-18D). In such an embodiment, the nose rest 12 positioned around the tip portion 11 may extend more widely on one side than on the other side (for example, as shown in FIGS. 18A-18D, one of the opposing sides may extend more widely than the other side). In the embodiment shown in Figures 18B to 18C, when viewed from above, one of the long side regions 12M of the nose rests facing each other across the line on which the axis of the tip portion 11 is located is Ｌ is the other long side region 12N ＬThe width of the nose rest may be larger than the width of the nose rest. It can also be said that the sizes of the regions of the nose rests facing each other across the tip (the size of the flattened regions) may differ from one another. In the exemplary embodiment shown in Figures 18A to 18D, the nose rest is provided with a narrow portion 12M having a relatively large width and a wide portion 12N having a relatively small width. With such a nose rest, the tip of the nasal spray / spray nozzle can be easily adjusted to the desired orientation and angle when it is placed in contact with the periphery of the nostril. In other words, the orientation and angle characteristics of the nasal spray / spray nozzle during use can be improved. For example, when the wide portion 12M of the nose rest is used so that it is positioned relatively higher (i.e., toward the nose poke), it becomes easier to position the nasal spray / spray nozzle with the tip more upright, i.e., with a larger angle α in Figure 46A (see Figure 22A), making it easier to spray / spray the medicine toward the upper region of the nasal cavity (e.g., the olfactory region). Conversely, when the wide portion 12M of the nose rest is used so as to be positioned relatively lower (i.e., toward the nasal cavity), it becomes easier to position the nasal spray / injection nozzle with the tip more tilted, i.e., with the angle α in Figure 46A becoming smaller (see Figure 22B), making it easier to spray / inject the medicine into the lower or deeper area of ​​the nasal cavity (e.g., the nasopharynx).

[0094] In one embodiment, when viewed from above, the outer contour of the tip portion may have a non-encircled portion that is not surrounded by the outer contour of the nose rest. In other words, the nose rest may be provided in a state where it is largely eccentric with respect to the axis of the nasal spray / spray nozzle. In this embodiment, as shown in Figures 19A to 19D, the outer contour 11P of the tip portion 11 is not entirely surrounded by the outer contour 12P of the nose rest 12, and only one non-encircled portion 11P of the outer contour 11P of the tip portion 11 is provided. ２ In this case, the outer contour 11P of the tip portion is the surrounding portion 11P １ and the non-enclosing part 11P ２ In this embodiment, the direction and angle characteristics of the nasal spray / injection nozzle during use can be more favorably improved.

[0095] In one embodiment, when viewed from above, the outer contour of the nose rest may have an arc-shaped portion on one side. That is, as shown in Figures 20A to 20C, at least a portion of the outer contour 12P of the nose rest 12 may be rounded rather than linear. Figure 20A shows an example of a nose rest in which the entire outer contour 12P has an arc-shaped portion, while Figures 20B and 20C show examples of nose rests in which only a portion of the outer contour 12 has an arc-shaped portion. In such an embodiment, the opposing sides of the outer contour of the nose rest may have different curvatures. For example, in the example shown in Figure 20C, the opposing sides 12P of the outer contour 12P of the nose rest may have different curvatures. １ and the other side portion 12P ２ About side part 12P １ The side part is 12P ２ The curvature is relatively smaller than that of the side portion 12P １ The side part is 12P ２ (The curve is relatively gentler than the curve in the figure.) When the outer contour of the nose rest has an arc shape in this way, the orientation and angle characteristics of the nasal spray / injection nozzle during use are more favorably improved. In other words, in this configuration, the shape of the nose rest when viewed from above is not angular. If the nose rest were angular, that portion could inconveniently interfere with the user's nose when using the nasal spray / injection nozzle. Therefore, in a configuration in which the outer contour of the nose rest has an arc shape on one side, the orientation and angle of the nasal spray / injection nozzle during use is more favorably changed or adjusted than in a configuration in which it is angular.

[0096] The arc-shaped outer contour of the nose rest may be used in combination with the above-described eccentric installation. For example, as shown in Figures 21A and 21B, in a top view of the nasal spray / injection nozzle, the non-encircling portion 11P of the outer contour of the nose rest ２ The portion 12P extending on both sides of Ｔ , 12P Ｕ The non-enclosed portion 11P may have an arc shape. This makes it easier to change the direction and angle of the nasal spray / spray nozzle during use.２ The portion 12P extending on both sides of Ｔ , 12P Ｕ The non-encircling portion 11P may have an elliptical arc shape. ２ The portion 12P extending on both sides of Ｔ , 12P Ｕ is a top view of the non-enclosed portion 11P ２ The nose rest 12 may have a shape symmetrical to each other with the center being the center. The overall shape of the nose rest 12 in a top view may be, for example, bean-shaped (see FIG. 21B). In this embodiment, the effect of making it easier to change the direction and angle of the nasal spray / spray nozzle during use may be more pronounced.

[0097] 22A and 22B show examples of usage modes of the nose rest shown in Fig. 21B. As shown, the orientation of the nose rest 12 can be reversed depending on the target area. The usage mode of Fig. 22A makes it easier to deliver the medication to the upper area of ​​the nasal cavity (e.g., the olfactory region), while the usage mode of Fig. 22B makes it easier to deliver the medication to the lower or deeper area of ​​the nasal cavity (e.g., the nasopharynx).

[0098] In one embodiment, the proximal surface of the nose rest may have a dome shape. That is, as illustrated in Figures 23A-23C (particularly Figures 23B and 23C), nose rest 12 may not be angular in side view, and the proximal surface may be entirely curved. This configuration not only makes it easier to change the direction and angle of the nasal spray / spray nozzle during use, but also reduces discomfort to the user due to resistance from the nose rest.

[0099] A nasal spray / spray nozzle 10 according to one exemplary embodiment is shown in Figure 24. The nose rest 12 provided on the nasal spray / spray nozzle 10 shown in Figure 24 has the above-mentioned characteristics. Specifically, the axis of the tip portion 11 and the center of the nose rest 12 are eccentrically offset from each other, and the outer contour of the tip portion 11 has a non-enclosed portion that is not surrounded by the outer contour of the nose rest 12. In addition, the proximal surface of the nose rest 12 has a dome shape. In a top view of the nose rest 12, the non-enclosed portion 11P of the outer contour of the tip portion ２ The portion 12P extending on both sides of Ｔ , 12P Ｕ has an elliptical arc shape (see FIG. 21B ). Such a nose rest 12 may be integrated with the tip portion 11 and / or the nozzle body portion 13 in advance, or may be detachable from the tip portion 11 and / or the nozzle body portion 13. FIG. 25 shows a detachable nose rest 12. Such a nose rest 12 may be attached to the tip portion 11 and / or the nozzle body portion 13, for example, by a snap fit. Specifically, the nose rest 12 may be attached and detached from the side thereof via a side opening 12G of the nose rest 12.

[0100] Various configurations are possible for attaching and detaching the nose rest 12. The nose rest 112 may be attached by covering the proximal end of the tip portion. This configuration is particularly possible when the detachable nose rest 12 does not have a side opening 12G as shown in FIG. 25. Alternatively, as shown in FIG. 26B, a recess 12W provided on the inner wall of the nose rest 12 may be utilized. If a protrusion that can complementarily engage with the recess 12W is provided on the tip portion 11 and / or the nozzle body 13, the nose rest 12 can be attached and detached through the engagement (e.g., interlocking) between them. The configuration of the recess and the protrusion can also be reversed. That is, a protrusion may be provided on the inner wall of the nose rest 12, and a recess may be provided on the tip portion 11 and / or the nozzle body 13.

[0101] In one embodiment, the nasal spray / spray nozzle 10 may further include a finger rest 14 for a finger to rest on (see, for example, Figures 6 and 7). In other words, the nasal spray / spray nozzle 10 may include a first increased diameter portion 12 resulting from the nose rest and a second increased diameter portion 14 resulting from the finger rest.

[0102] As used herein, the term "finger rest" refers, in a broad sense, to a portion on which a finger is placed when using a nasal spray / spray nozzle, and, in a narrow sense, to a portion on which a finger is placed when inserting the nasal spray / spray nozzle into a nasal cavity. From this perspective, the finger rest may also be referred to as a "finger rest portion" or a "finger grip." In the present invention, the finger rest is provided relatively distally of the nose rest in the nasal spray / spray nozzle. For example, in the nasal spray / spray nozzle 10, the second increased diameter section 14 resulting from the finger rest and the first increased diameter section 12 resulting from the nose rest are provided at a distance from each other along the nozzle axial direction, with the second increased diameter section 14 being provided relatively distally of the first increased diameter section 12.

[0103] By providing a finger rest to the nasal spray / spray nozzle, handling during spraying of the medicine can be improved.

[0104] The finger rest may have any shape as long as it allows a finger to be placed thereon. For example, when viewed from above the nasal spray / spray nozzle 10, the outer contour of the finger rest 14 may be positioned so as to surround at least a portion of the outer contour of the tip portion 11 (see FIG. 6C, etc.). With such a configuration, a finger can be placed on the finger rest 14 so as to easily move the finger in the direction of operation of the nasal spray / spray nozzle 10 (see FIG. 6B). The finger rest may be made of a material with a constant thickness, for example.

[0105] When viewed from above, the finger rest 14 of the nasal spray / injection nozzle 10 may have a generally circular shape, a generally elliptical shape, a polygonal shape, a chamfered polygonal shape, or the like (see FIGS. 27A to 27G).

[0106] From the perspective of placing greater importance on ease of handling, the finger rest 14 may have a generally elliptical or rectangular shape in top view (see FIGS. 27B and 27C). The finger rest 14 may also include a finger guide 14' (see FIGS. 27D and 27E). This configuration makes it easier to determine the position where the fingers are placed. This also makes it easier to determine the optimal insertion position and direction of the nozzle ejection hole. Note that FIGS. 27A to 27E are merely examples, and the finger rest 14 may have a shape in top view as shown in, for example, FIGS. 27F and 27G.

[0107] When viewed from above, the width of the finger rest 14, for example, the diameter D ４ The diameter D of the finger rest 14 may be 15 mm or more and 60 mm or less (see Figures 27A to 27G). When the diameter is 15 mm or more, the finger can be more easily held. When the diameter is 60 mm or less, the nasal spray / injection nozzle 10 can be more easily handled. ４ is preferably 17 mm or more and 50 mm or less, for example, 20 mm or more and 45 mm or less.

[0108] Here, "diameter D ４ " may be considered to be the maximum diameter of the finger rest 14. For example, as described above, it may refer to the diameter of a circle, ellipse, inscribed circle, or inscribed ellipse in the shape of the finger rest 14 when viewed from above. In the case where the finger rest 14 includes a finger guide 14' (see, for example, FIGS. 27D and 27E), it may refer to the diameter of a circle, ellipse, inscribed circle, or inscribed ellipse in the shape of the finger rest 14 excluding the finger guide 14'.

[0109] In one embodiment, the diameter N-N' of the nose rest 12 and the diameter F-F' of the finger rest 14 are substantially perpendicular to each other when viewed from above in the nasal spray / injection nozzle 10 (see FIG. 7C ). This configuration makes it easier to determine the direction of the nozzle outlet 11A within the nasal cavity.

[0110] Here, "substantially perpendicular" does not necessarily have to be a perfect 90° angle. For example, "substantially perpendicular" may be in the range of 90°±10°. In the illustrated embodiment, the diameter N-N' of the nose rest 12 and the diameter F-F' of the finger rest 14 form an angle of 90° (see FIG. 7C ).

[0111] In the above-described embodiment, the major axis N-N' of nose rest 12 and the major axis F-F' of finger rest 14 may be substantially perpendicular to each other when viewed from above of nasal spray / injection nozzle 10. Specifically, nose rest 12 and finger rest 14 may have a substantially elliptical or rectangular shape when viewed from above, and their respective major axes may be substantially perpendicular to each other.

[0112] In other words, the nose rest 12 and the finger rest 14 may form a substantially cross shape when viewed from above the nasal spray / injection nozzle 10 (see FIG. 7C ). Preferably, the major axes N-N' and F-F' are symmetrical about an axis (i.e., they intersect at the center) to form a substantially cross shape.

[0113] In other words, in a top view of the nasal spray / injection nozzle 10, the nose rest 12 and the finger rest 14 overlap each other, but the two non-overlapping portions 12A of the nose rest 12 are １ and 12A ２ and the two non-overlapping portions 14A of the finger rest 14. １ and 14A ２ and the opposing directions may be substantially perpendicular to each other (see FIG. 7C).

[0114] The above-described configuration facilitates easier and more accurate alignment of the nasal spray / spray nozzle with respect to the nostril, particularly in determining the direction of the nozzle orifice 11A within the nasal cavity.

[0115] In one embodiment, the axes of the nose rest 12 and the finger rest 14 may coincide when viewed from above the nasal spray / spray nozzle 10 (see, for example, FIG. 7C ). In other words, the nose rest 12 and the finger rest 14 may have the same axis in the nasal spray / spray nozzle 10. Such a configuration makes it easier to further improve the handleability of the nasal spray / spray nozzle 10.

[0116] In one embodiment, in a side view of the nasal spray / spray nozzle 10, the distance O between the nose rest 12 and the finger rest 14 may be 10 mm or more and 50 mm or less, for example, 10 mm or more and 30 mm or less (see FIG. 7B ). In other words, the length O of the nozzle body 13 or a portion thereof in the nasal spray / spray nozzle 10 may be 10 mm or more and 50 mm or less, for example, 10 mm or more and 30 mm or less.

[0117] When the above dimension is 10 mm or more, it becomes easier to prevent fingers from interfering with the nose rest when placed on the finger rest. Furthermore, when the dimension is 50 mm or less, it becomes easier to particularly improve handling during medicine injection.

[0118] The distance between the nose rest and the finger rest may be different when the nasal spray / spray nozzle is used by the user himself or herself and when it is used by a third party. When the nasal spray / spray nozzle is used on the user himself or herself, the distance O between the nose rest and the finger rest is preferably 15 mm or more and 30 mm or less, for example, 15 mm or more and 25 mm or less. On the other hand, when the nasal spray / spray nozzle is used on a third party, the distance O between the nose rest and the finger rest may be 50 mm or more and 70 mm or less.

[0119] (Nasal spray / spray device) In addition to conventional spray / spray devices, nasal spray / spray devices using the nasal spray / spray nozzle according to the present invention include those in which the nasal spray / spray nozzle is incorporated into an upward-exhaust airless spray / spray device or a syringe-type spray / spray device. Here, the upward-exhaust airless spray / spray device and the syringe-type spray / spray device will be described in detail.

[0120] (Upward-relief airless spray / spray device) Figure 28 illustrates an embodiment of an upward-relief airless spray / spray device 100 equipped with a nasal spray / spray nozzle 10 according to one embodiment of the present invention. When using the upward-relief airless spray / spray device 100, the protective cap 110 is removed. The spray / spray device 100 is an upward pressure-exhausting airless spray / spray device 100 in which the contents sucked into the suction chamber 150 of the pump 120 from inside the container 140 are sprayed out through a spray hole by removing the protective cap 110 and pressing down on the annular operating portion 130 (i.e., the finger rest 14 of the nasal spray / spray nozzle 10) of the pump 120 attached to the head of the spray / spray device 100, and which is equipped with a sliding bottom lid body 160 that slides upward in conjunction with the suction to exhaust the air inside the container 140, and in which the annular outer surface portion of the pump 120 (i.e., the upper annular outer surface portion 121 and the lower annular outer surface portion 122) is formed around the sliding bottom lid body 160 and moves in a sealed state while being pressed against the inner circumferential surface 141 of the container.

[0121] In other words, an upward pressure exhaust airless spray / spray device comprises a container for storing medicine, a pump for sucking the medicine from the container, and a nasal spray / spray nozzle for spraying the medicine, all fluidly connected in this order, and the pump sucks the medicine from the container and sprays it out from the nasal spray / spray nozzle, and is equipped with a sliding bottom lid body that slides upward in conjunction with the suction to exhaust air from inside the container.

[0122] 29, the upward pressure exhaust airless spraying / spraying device 100 is equipped with a ring 190 to remove unnecessary space, and the normally flat sliding bottom cover body 160 is angled to allow air to escape easily from the upward pressure exhaust airless spraying / spraying device 100, greatly reducing the amount of medicine remaining after use.

[0123] The upward pressure airless spray / spray device with the above-mentioned features ensures the accuracy of the spray or spray amount required for ordinary pharmaceuticals. If the angle of the sliding bottom cap body is too small, a gap will remain in the shoulder of the container body when the drug is filled, while if it is too large, a gap will remain in the base of the sliding bottom cap, which is inconvenient. The angle is preferably between 5 and 30°, and more preferably between 15 and 25°.

[0124] Furthermore, the above-mentioned upward exhaust airless spray / spray device is not a system that takes in outside air, and therefore has the extremely useful property of being less susceptible to microbial contamination from outside air, making it an extremely excellent nasal administration system in terms of safety and manufacturing costs, as it does not require more preservatives than necessary.

[0125] The upward pressure airless spraying / spraying device according to the present invention can spray / spray at any administration angle, contributing to more suitable nozzle use (see Figures 30A to 30F). In other words, the above-described spray / spraying device can be used at any administration angle or range of angles between 0° and 360°. For example, in the case of nasal administration, the above-described nasal spray formulation can be used by varying the administration angle between the administration position (head angle) and the spray container. That is, spray / spray is possible from an angle of approximately 0°, between 45° and 90°, and even up to 180°.

[0126] Here, by tilting the head back and using the container at an administration angle of 65° or more and 180° or less, the nasal turbinates (nasal passages) change from a parallel to a vertical direction, and it is thought that the drug can first be dispersed and attached to the tip of the nasal turbinates.The drug captured and deposited in the nasal turbinates is carried backward by gravity and the ciliary movement of the ciliated cells covering the mucous membrane, allowing the drug to be distributed over a wide area of ​​the nasal turbinates.

[0127] Therefore, the administration angle between the administration position and the spray container may be any angle between 0° and 180°, preferably between 45° and 180°, more preferably between 65° and 180°, and most preferably around 135°, at which the nasal turbinates (nasal passages) are vertical and the angle at which the drug can be distributed over a wide range of the nasal turbinates is the most advantageous and desirable. Furthermore, the administration position may be any of standing, sitting, supine, and lateral positions, and the nasal drops of the present invention can be used at any administration angle.

[0128] 31 illustrates an embodiment of a syringe-type spray / spray device 200 equipped with a nasal spray / spray nozzle 10 according to one embodiment of the present invention. Syringe-type spray / spray device 200 comprises a syringe body 230 equipped with a syringe barrel 220, a plunger rod 240 inserted into syringe barrel 220 of syringe body 230, a piston 260 attached via a fixing portion 240a provided on the distal end of plunger rod 240, and a finger rest 270 disposed around the proximal end of syringe body 230. More specifically, as shown in FIG. 31 , syringe-type spray / ejection device 200 has a syringe body 230 made of synthetic resin or glass having a syringe barrel 220 that can be filled with drug 210, a plunger rod 240 that is inserted into syringe barrel 220 of syringe body 230, a piston 260 that is attached via a fixing portion 240 a provided on the distal end of plunger rod 240 and slides into syringe barrel 220 to discharge the drug in syringe barrel 220 from a distal tip opening 250 of syringe body 230, a finger rest 270 that is arranged around the proximal end of syringe body 230 and transmits force applied from the fingers of a practitioner such as a doctor to plunger rod 240, and a plunger operating portion 280.

[0129] As shown in Fig. 31 , the syringe-type spray / spray device 200 further has a nasal spray / spray nozzle 10 arranged opposite the tip opening 250 of the syringe body 230. Here, the nasal spray / spray nozzle 10 may be the nasal spray / spray nozzle 10 exemplified in Fig. 4 . The nasal spray / spray nozzle 10 may further have a protective cap (not shown) to protect the tip 11 from contaminants and mechanical impact. The protective cap may be configured to cover the entire nozzle, or may be configured to cover only the tip.

[0130] Figures 32A and 32B are partially cutaway exploded perspective views showing the schematic configuration of a nasal spray / spray nozzle 10 according to one embodiment of the present invention. As shown, the nasal spray / spray nozzle 10 has a hollow nozzle body 13 having a nozzle ejection end surface 11B in which a nozzle ejection orifice 21 is formed, and a solid filling rod (filler rod) 30 disposed within the nozzle body 13. Figures 32A and 32B show the states before and after the filling rod 30 is disposed in or inserted into the nozzle body 13. The nozzle ejection end surface 11B of the nozzle body 13 has a substantially circular shape, and the nozzle ejection orifice 11A is formed in the center of the nozzle ejection end surface 11B.

[0131] Figure 33A is a vertical cross-sectional view of the nasal spray / spray nozzle 10 shown in Figure 32B, taken along a vertical plane passing through the nozzle orifice 11A. Figures 33B to 33D are horizontal cross-sectional views taken along lines B-B, C-C, and D-D in Figure 33A, respectively. The hollow nozzle body 13 has an inner wall 20 that defines a substantially cylindrical internal space 22. As shown in Figures 33C and 33D, the internal space 22 has a small-diameter nozzle section 23 that is closer to the nozzle orifice 11A of the hollow nozzle body 13, a large-diameter nozzle section 24 into which the large-diameter rod section 34 of the filling rod 30 is inserted, and a nozzle shoulder 25 that is formed so that the diameter of the internal space 22 decreases continuously or stepwise from the large-diameter nozzle section 24 toward the small-diameter nozzle section 23.

[0132] On the other hand, the solid filling rod 30 inserted into the nozzle main body 13 has an outer wall 31 having an external shape that is approximately complementary to the inner wall 20 (internal space 22) of the nozzle main body 13, and has a rod shoulder 35 formed so that the diameters of the rod large diameter portion 34 and the rod small diameter portion 33 decrease continuously or in steps from the rod large diameter portion 34 toward the rod small diameter portion 33, as shown in Figures 32A, 33C, and 33D.

[0133] As shown in Figure 32A, it is preferable to provide a protrusion 21 on the inner wall 20 of the nozzle main body 13 and a recess 32 for receiving the protrusion 21 on the outer wall 31 of the filling rod 30, so that when the filling rod 30 is inserted into the internal space 22 of the nozzle main body 13, the protrusion 21 and the recess 32 fit together to ensure secure fixation.

[0134] 32A, 32B, and 33A to 33D, the filling rod 30 has a plurality of grooves 36, 37 spaced apart in the circumferential direction in the rod small diameter portion 33 and the rod large diameter portion 34. The filling rod 30 is inserted into the nozzle body 13 so that a gap 38 (FIG. 33A) is formed between the nozzle shoulder 25 and the rod shoulder 35. Therefore, in the nasal spray / spray nozzle 10 assembled as shown in FIG. 32B, a nozzle chamber 39 that is fluidly communicable by the grooves 36, 37 and the gap 38 is formed, and the medicine 210 delivered from the tip opening 250 of the syringe body 230 can be guided to the nozzle ejection end surface 11B of the nasal spray / spray nozzle 10 via the nozzle chamber 39.

[0135] Furthermore, as shown in FIG. 33B , the filling rod 30 has a vortex-forming section 40 that faces the nozzle ejection end surface 11B of the nasal spray / spray nozzle 10. The vortex-forming section 40 is configured to form a vortex of the medicine 210 that flows in through each groove 36 of the rod small diameter section 33 before it is ejected from the nozzle ejection hole 11A of the nozzle main body 13. Specifically, the end portion of the rod small diameter section 33 that constitutes the vortex-forming section 40 is formed to extend in a direction offset from the vertical central axis of the nozzle ejection hole 11A. By forming a vortex before the medicine 210 is ejected from the nozzle ejection hole 11A in this way, the ejection angle of the medicine can be increased, allowing the medicine to be sprayed or sprayed more uniformly.

[0136] 33C and 33D, it is preferable to design the groove 36 of the rod small diameter portion 33 smaller than the groove 37 of the rod large diameter portion 34, thereby increasing the pressure of the medicine in the vortex flow forming portion 40 before it is sprayed from the nozzle ejection hole 11A. Furthermore, the diameters of the rod large diameter portion 34 and the rod small diameter portion 33 are designed to decrease continuously or in stages from the rod large diameter portion 34 to the rod small diameter portion 33, which facilitates deep insertion into the nasal cavity of a user, such as a patient, and facilitates spraying or spraying of the medicine near and deep within the user's inferior turbinate. In other words, it is preferable that the diameter of the rod small diameter portion 33 be sufficiently smaller than the user's nostrils so as not to frighten the user.

[0137] In other words, the syringe-type spray / spray device comprises a syringe body that contains a medicine and a nasal spray / spray nozzle that is fluidically connected to the syringe body, the syringe body having a plunger rod and piston for ejecting the medicine, as well as a finger rest and plunger operating part that work in conjunction with the plunger rod, and the nasal spray / spray nozzle further having a filling rod disposed within the nozzle and a nozzle chamber that is formed between the filling rod and the inner wall of the nozzle and is fluidically connected to the nozzle outlet hole.

[0138] Figure 34 shows a syringe-type spray / spray device 200 including a nasal spray / spray nozzle 10 according to one embodiment of the present invention. In the embodiment of Figure 34, the nasal spray / spray nozzle 10 has a nose rest 12, and the syringe body 230 has a finger rest 270.

[0139] In addition, when viewed from above, the outer contours of the nose rest 12 and the finger rest 14 are positioned so as to surround the outer contour of the tip 11. This configuration allows the fingers to come into contact with the nasal spray / spray nozzle 10 and move easily in the operating direction.

[0140] In one embodiment, the nose rest 12 of the nasal spray / spray nozzle 10 and the finger rest 14 of the syringe body 230 may be substantially elliptical or rectangular (see FIG. 35). The major axes of the nose rest 12 and the finger rest 14 are perpendicular to each other.

[0141] In the above-described embodiment, the major axis of nose rest 12 and the major axis of finger rest 14 may be approximately perpendicular to each other when viewed from above of nasal spray / injection nozzle 10. Specifically, nose rest 12 and finger rest 14 may be approximately elliptical or rectangular, and their respective major axes may be approximately perpendicular to each other.

[0142] In other words, the nose rest 12 and the finger rest 14 form a substantially cross shape when viewed from above the nasal spray / injection nozzle 10. Here, the major axes of the nose rest 12 and the finger rest 14 may be substantially cross-shaped so as to be line-symmetrical with each other.

[0143] In other words, when viewed from above, the nose rest 12 and the finger rest 14 overlap each other, but the opposing direction of the two non-overlapping portions of the nose rest 12 and the opposing direction of the two non-overlapping portions of the finger rest 14 may be approximately perpendicular to each other.

[0144] The above-described configuration facilitates easier and more accurate alignment of the nasal spray / spray nozzle with respect to the nostril, as will be described later, and thus makes it easier to determine the direction of the nozzle outlet 11A within the nasal cavity.

[0145] (Rest of the Present Invention) According to the technical concept of the present invention, a nasal drop rest 300 such as that shown in Fig. 36 is also conceivable. Such rest 300 comprises a nose rest 12 that can contact the periphery of the nostrils and a finger rest 14, and is designed to be attachable to, for example, a conventional spray / spray device, an upward pressure airless spray / spray device, or a syringe-type spray / spray device (hereinafter collectively referred to as a "spray / spray device"). In other words, the rest 300 is a component part for a spray / spray device, and is a component part that provides the nose rest 12 and finger rest 14 for such a device.

[0146] 36 , in the rest item 300, the nose rest 12 and the finger rest 14 are integrated. More specifically, the nose rest 12 and the finger rest 14 are connected via, for example, a cylindrical portion 350. By placing such a rest item 300 over a spray / spray device (preferably by placing the rest item 300 over the nozzle side), it is possible to provide both the nose rest 12 and the finger rest 14 for the device. For example, by placing the rest item 300 over the device so that the barrel portion of an upward pressure-reducing airless spray / spray device or a syringe-type spray / spray device is positioned inside the cylindrical portion 350 of the rest item 300, it is possible to suitably provide the nose rest 12 and the finger rest 14 for the syringe-type spray / spray device.

[0147] In the rest member 300 according to the present invention, the nose rest 12 and the finger rest 14 may be substantially elliptical or rectangular, and the major axes of the nose rest 12 and the finger rest 14 may be perpendicular to each other (see FIG. 36 ). That is, in a top view of the rest member 300, the nose rest 12 and the finger rest 14 may form a substantially cross shape. Furthermore, in a top view of the rest member 300, the nose rest 12 and the finger rest 14 may overlap each other, but the opposing direction of the two non-overlapping portions of the nose rest 12 and the opposing direction of the two non-overlapping portions of the finger rest 14 may be substantially perpendicular to each other. Use of such a nozzle member allows for easier and more accurate alignment of the nasal spray / spray nozzle with the external nostril. As shown in FIG. 36 , in a rest member 300 used with a syringe-type spray / spray device, the distance between the nose rest 12 and the finger rest 14 may be, for example, approximately 50 mm to 80 mm.

[0148] (Regarding Drug Properties) The formulation properties (pH, viscosity, surface tension, osmotic pressure, etc.) of the drug used in the above-mentioned nasal spray / spray device are not particularly limited. In particular, viscosity has a significant effect on spray / spray properties, but is not particularly limited. Therefore, the drug may be in the form of, for example, a liquid, gel, or slurry. For example, the viscosity of the drug may be 1 mPa s or more and 5000 Pa s or less, and in some embodiments, 250 Pa s or more and 2500 Pa s or less.

[0149] If the viscosity of the drug is 250 Pa·s or less, even if the drug is delivered to the target area, dripping tends to occur and the drug tends to be washed away from the area. If the viscosity is 5000 Pa·s or more, the predetermined distance (C) 51 from the nozzle ejection hole where the drug forms a film (i.e., narrow diffusion region) becomes longer, making the film less likely to break, and making it easier for the drug to remain in the target area.

[0150] (Method of Using the Spray / Spray Device) Figure 37 illustrates an example of a method of using an upward pressure airless spray / spray device 100 equipped with the nasal spray / spray nozzle 10 shown in Figure 7. That is, the nasal spray / spray nozzle 10 shown in Figure 37 has a nose rest 12 and a finger rest 14.

[0151] A user uses the spray / spray device 100, for example, in the following manner: (1) Place two fingers (e.g., index finger and middle finger) on the finger rest 14 at positions facing each other across the nozzle body 13. (2) Position the nasal spray / spray nozzle 10 so that the parallel orientation of the two placed fingers is approximately parallel to the longitudinal direction of the bridge of the nose. (3) Insert the tip 11 of the nasal spray / spray nozzle 10 into the nasal cavity. Insert the tip 11 until the nose rest 12 presses against the periphery of the external nostril (e.g., the bridge of the nose and the ala of the nose) (see Figures 37 and 38). (4) Press the finger rest 14 toward the distal side of the nasal spray / spray nozzle 10 (the operating direction side as shown in the figure) to spray the medicine into the nasal cavity.

[0152] In the nasal spray / spray nozzle 10 shown in Figure 37, the major axis N-N' of the nose rest 12 and the major axis F-F' of the finger rest 14 may be approximately perpendicular (see Figure 7C). When such a nasal spray / spray nozzle 10 is positioned using procedure (2), the major axis of the nose rest 12 inevitably tends to approximately coincide with the direction connecting the columella and ala of the nose (see Figure 38). This allows the nose rest 12 to fit more closely with the columella and ala of the nose.

[0153] Figure 39 shows one embodiment of the nasal spray / spray nozzle 10 inserted into the nasal cavity using the procedure described above. As shown in Figure 39, the nose rest 12 is abutted against the periphery of the nostril, which facilitates determining the insertion position and direction of the nozzle orifice 11A so that the tip 11 or the sprayed medicament 50 can pass through the narrow nasal cavity area around the nasal valve. This facilitates a higher medicament delivery rate in the target area and / or facilitates delivery of the medicament to a wider area of ​​the target area (e.g., respiratory area, olfactory area, or nasopharynx).

[0154] The sprayed medicine 50 includes a narrow diffusion region 51 immediately after spraying and a wide diffusion region 52 where the droplets become finer than the narrow diffusion region 51 (see FIG. 40). Without being bound by any particular theory, it is believed that immediately after spraying, the medicine has a film formed on its outer edge and is in a converged state, but after passing a certain spray distance, the film is broken and the droplets become fine droplets. Specifically, the membrane of the medicine can be broken and the droplets can be converted into fine droplets at a spray distance C from the nozzle nozzle hole 11A that is between 5 mm and 15 mm.

[0155] In order to deliver the drug to a wide range of target areas, it is important that the tip 11 or the narrow diffusion area 51 of the sprayed drug 50 can pass through the narrow nasal cavity area around the nasal valve (see Figures 39 and 40). Here, it is known that the distance from the external nares to the nasal valve is about 20 mm.

[0156] The length dimension of the tip 11 of the nasal spray / injection nozzle 10 according to the present invention is, for example, 5 mm or more and 30 mm or less, so that the tip 11 or the medicine 50 can pass through the narrow diffusion area 51.

[0157] In order to prevent contact with the inner walls of the nasal cavity around the nasal valve and to deliver the drug over a wide range of target areas, it is preferable that only a narrow diffusion area 51 of the drug 50 being sprayed passes through the narrow nasal cavity area around the nasal valve (see Figures 39 and 40).

[0158] To achieve the above-described embodiment, the length of the tip portion 11 may be, for example, 10 mm to 25 mm, 7 mm to 18 mm, 8 mm to 17 mm, 9 mm to 16 mm, or 10 mm to 15 mm (for example, approximately 15 mm). Here, the length of the tip portion 11 refers to the length from the proximal end of the nose rest 12 to the surface on which the nozzle orifice 11A is formed.

[0159] In particular, when the length dimension of the tip portion 11 is the above dimension, the nozzle ejection hole 11A can be easily positioned just before the nasal valve, and the medicine 50 sprayed into the narrow nasal cavity area around the nasal valve can easily pass through the narrow diffusion area 51. Furthermore, since a sufficient distance can be secured between the nozzle ejection hole 11A and the target area, the medicine can be more effectively delivered to a wide area of ​​the target area.

[0160] Although the embodiments of the present invention have been described above, they are merely typical examples. Therefore, it will be readily understood by those skilled in the art that the present invention is not limited to these and that various other embodiments are possible.

[0161] For example, a nose rest 12 having a difference in thickness has been described with reference to Figures 12 and 13. The nose rest 12 having such a difference in thickness has its upper surface (proximal surface) partially or entirely inclined, and such an inclined configuration can be realized in various ways. For example, the inclined surface of the nose rest 12 may be as shown in Figures 41 and 42. That is, in side views as shown in Figures 41B and 42B, the nose rest 12 may have a constant thickness (substantially constant thickness) and be inclined at an angle relative to a direction perpendicular to the axis of the tip portion 11.

[0162] Furthermore, although the above description uses the term "target region," the present invention is not necessarily limited thereto. The term "target site," which is essentially synonymous with the target region, may also be used. That is, the present invention may be understood with the term "target site" instead of or in addition to the term "target region." When rhinitis or the like is anticipated, the target site may be the nasal turbinate (inferior turbinate and / or middle turbinate). For example, when the nasal turbinates are swollen and nasal congestion occurs due to allergic rhinitis or other conditions, the use of the nasal spray / spray nozzle of the present invention can increase the rate at which the drug reaches the inferior turbinate and middle turbinate. Furthermore, when a nasal drop formulation is used that is expected to have a systemic effect through nasal mucosal absorption via the nasal mucosa in the respiratory portion of the nasal cavity, the target site may be the middle part of the nasal cavity. When a nasal drop formulation is used that is expected to have an antibody production effect through nasal vaccination by utilizing the strong immune response of the nasopharynx, the target site may be the nasopharynx. Furthermore, since a pathway that leads directly from the olfactory mucosa to the brain is known, improving the amount of drug that reaches the olfactory mucosa will increase the possibility of drug delivery from the nose to the brain. Therefore, when a nasal drop preparation is used that is expected to have an effect on the central nervous system, the olfactory mucosa may be the target site.

[0163] Furthermore, while the above description has focused on the external structure of the nasal spray / spray nozzle, its internal or inner structure is not particularly limited and may be the same as that of a conventional nasal spray / spray nozzle. In other words, the internal or inner structure of the nasal spray / spray nozzle is not particularly limited and may be any structure as long as it contributes to the nozzle function (e.g., spraying / spraying a medicine).

[0164] An embodiment related to the present invention will now be described.

[0165] A demonstration test was conducted using the following test nozzle, which simulates a nasal spray / spray nozzle. ● Comparative Example 1: Nasal spray / spray nozzle without a nose rest (see Figure 43A) - Diameter of the surface where the nozzle outlet hole is formed: 8 mm - Spray amount: 100 mg (used when attached to a pump with a spray amount of 100 mg) ● Comparative Example 2: Nasal spray / spray nozzle without a nose rest (see Figure 43B) - Diameter of the surface where the nozzle outlet hole is formed: 4 mm - Spray amount: 100 mg (used when attached to a pump with a spray amount of 100 mg) ● Comparative Example 3: Nasal spray / spray nozzle without a nose rest (see Figure 43C) - Diameter of the surface where the nozzle outlet hole is formed: 4.5 mm - Spray amount: 250 mg (used when set in a 1.0 mL syringe barrel) ● Example 1: Nasal spray / spray nozzle (see Figure 44A) the same as Comparative Example 1 except that it is equipped with a nose rest. - The nose rest is provided so that the length of the tip is 10 mm or 15 mm. ● Example 2: Nasal spray the same as Comparative Example 2 except that it is equipped with a nose rest - Spray nozzle (see Figure 44B) - A nose rest is provided so that the length of the tip is 15 mm. ● Example 3: Nasal spray the same as Comparative Example 3 except that it is equipped with a nose rest - Spray nozzle (see Figure 44C) - A nose rest is provided so that the length of the tip is 10 mm, 15 mm or 20 mm.

[0166] Confirmation of spray state The spray state of the drug was confirmed using a nasal spray / spray. Since the liquid drug requires strong adhesion at the deposition site in order to measure the mass, it was prepared according to the manufacturing method described in Patent No. 5185109 of Toko Pharmaceutical Co., Ltd. It was confirmed that all of the above nasal spray / spray nozzles were able to sufficiently spray in a fine mist regardless of the spray angle and drug viscosity. Specifically, it was confirmed that with all of the above nasal spray / spray nozzles of Comparative Examples 1 to 3 and Examples 1 to 3, the droplet size distribution was sprayed in a range of 10 to 100 μm with 70% or more of the droplets being in a spray state regardless of the spray angle and drug viscosity.

[0167] Test to confirm the effectiveness of the nose rest A silicone 3D nasal cavity model (manufactured by Takaken Co., Ltd.) (see Figure 45) was used. The nozzle position and angle of the nasal spray nozzle used in the nasal cavity model during testing are shown in Figure 46. Figure 46A shows the angle α, which is the angle formed with respect to a plane parallel to the nasal septum, and Figure 46B shows the angle β, which is the angle formed with respect to a plane perpendicular to the nasal septum.

[0168] When the target site for spraying was the "nasal turbinates," a removable partition was placed at the tip of the inferior and middle turbinates. The mass of the partition was measured before and after spraying the medication from the nasal spray / spray nozzle, and the amount deposited on the partition was calculated from the difference. The mass of the medication deposited on the nasal septum posterior to the partition was also measured and recorded as the amount of medication that reached the nasal turbinates. When the target site for spraying was the "middle nasal cavity," the mass of medication deposited on the posterior cross-section of a nasal cavity model cut vertically at the center of the nasal cavity was measured and recorded as the amount of medication that reached the middle nasal cavity. When the target site for spraying was the "nasopharynx," the mass of medication deposited on the posterior cross-section of a nasal cavity model cut vertically at the nasopharynx at the rear (posterior surface) of the nasal cavity model was measured and recorded as the amount of medication that reached the nasopharynx. When the target site of the sprayed object was the "olfactory mucosa site," the mass of drug deposited on the upper cross section of the nasal cavity model, cut parallel to the top of the nasal cavity model, was measured and used as the amount of drug that reached the olfactory mucosa site. The "target site arrival rate" was calculated as the ratio of the amount of drug that reached the target site to the amount sprayed. In addition, the test was performed multiple times, and RSD (relative standard deviation) was calculated to understand the variation in the target site arrival rate.

[0169] The results are shown in Tables 1 to 16.

[0170]

[0171] As shown in Tables 1 to 16, it was found that the nasal spray / spray nozzles equipped with a nose rest (Examples 1 to 3) had a higher drug delivery rate to the target site than the nasal spray / spray nozzles without a nose rest (Comparative Examples 1 to 3). It was also found that the nasal spray / spray nozzles equipped with a nose rest (Examples 1 to 3) had less variation in drug delivery rate than the nasal spray / spray nozzles without a nose rest (Comparative Examples 1 to 3). In other words, it was confirmed that the nasal spray / spray nozzle according to the present invention has improved drug delivery characteristics.

[0172] The nasal spray nozzle according to the present invention can deliver medicine to a more suitable target area in a complex nasal cavity structure. Specifically, by abutting the nose rest against the periphery of the nostril, the insertion position of the nozzle orifice within the nasal cavity can be determined. This allows for the delivery of medicine to a wider range of the target area, resulting in a nasal spray / spray medical device with higher medicinal efficacy.

[0173] 10: Nasal spray / spray nozzle 11: Tip 11A: Nozzle ejection hole 11B: Nozzle ejection end surface 12: Nose rest 12E: Proximal end of nose rest 12S: Inclined surface of nose rest 13: Nozzle main body 13': Syringe connecting protrusion 14: Finger rest 14': Finger guide 15: Insertion direction marker 15a: Notched surface 20: Inner wall of nozzle main body 21: Protrusion 22: Internal space 23: Nozzle small diameter portion 24: Nozzle large diameter portion 25: Nozzle shoulder 30: Filling rod (filling rod) 31: Outer wall of filling rod 32: Recess 33: Rod small diameter portion 34: Rod large diameter portion 35: Rod shoulder 36, 37: Groove 38: Gap 39: Nozzle chamber 40: Swirl forming portion 50: Medicament to be sprayed 51: Narrow diffusion area 52: Wide diffusion area 100: Upward exhaust pressure airless spray / spray device 110: Protective cap 120: Pump 121: Upper annular outer peripheral surface portion 122: Lower annular outer peripheral surface portion 130: Annular operation portion (finger rest) 140: Drug container 141: Inner peripheral surface 150: Suction chamber 160: Sliding bottom lid main body 170: Fixed bottom lid 180: Vent hole 190: Ring 200: Syringe-type spray / spray device 210: Drug 220: Syringe barrel 230: Syringe main body 240: Plunger rod 240a: Fixed portion 250: Tip opening 260: Piston 270: Finger rest 280: Plunger operation portion 300: Nasal drop rest item 350: Cylindrical portion

Claims

1. A nasal spray / injection nozzle comprising a tip portion having a nozzle outlet hole and a nose rest capable of contacting the periphery of the external nostril.

2. The nasal spray / spray nozzle according to claim 1, wherein, when viewed from above, the outer contour of the nose rest surrounds at least a portion of the outer contour of the tip.

3. The nasal spray / spray nozzle according to claim 1 or 2, wherein the nose rest is substantially elliptical in shape when viewed from above.

4. A nasal spray / injection nozzle as described in any one of claims 1 to 3, wherein the nose rest has a portion whose diameter decreases toward the nozzle outlet hole.

5. The nasal spray or injector nozzle of claim 4, wherein said nose rest includes relatively steep surfaces and relatively non-steep surfaces.

6. A nasal spray / injection nozzle according to any one of claims 1 to 5, wherein the spray direction of the nozzle outlet forms an angle with respect to the axis of the nasal spray / injection nozzle.

7. A nasal spray / injection nozzle as described in any one of claims 1 to 6, wherein the nose rest has a fitting surface for fitting with the periphery of the external nares.

8. A nasal spray / injection nozzle according to any one of claims 1 to 7, wherein the length dimension of the tip portion is 10 mm or more and 25 mm or less when viewed from the side.

9. A nasal spray / injection nozzle as described in any one of claims 1 to 8, wherein the tip portion has a portion that gradually tapers toward the nozzle outlet hole.

10. A nasal spray / injection nozzle as described in any one of claims 1 to 9, wherein the diameter of the surface at the tip where the nozzle ejection hole is formed is 3 mm or more and 10 mm or less.

11. A nasal spray / spray nozzle as described in any one of claims 1 to 10, wherein, when viewed from above, the axis of the tip and the center of the nose rest have an eccentric relationship in which they are offset from each other.

12. A nasal spray / spray nozzle as described in any one of claims 1 to 11, wherein, when viewed from above, the outer contour of the tip portion has a non-encircled portion that is not surrounded by the outer contour of the nose rest.

13. The nasal spray / injection nozzle of claim 12, wherein, in a top view of the nasal spray / injection nozzle, the portions of the outer contour of the nose rest extending on both sides of the non-encircling portion have an arc shape.

14. The nasal spray / spray nozzle according to any one of claims 1 to 13, further comprising a finger rest for placing a finger.

15. The nasal spray / spray nozzle according to claim 14, wherein, when viewed from above, the major axis direction of the nose rest and the major axis direction of the finger rest are approximately perpendicular to each other.

16. A nasal spray / spray nozzle according to any one of claims 1 to 15, wherein the target area that is the object of spraying / spraying from the nasal spray / spray nozzle is the respiratory area.

17. A nasal spray / spray nozzle according to any one of claims 1 to 15, wherein the target area to be sprayed / sprayed by the nasal spray / spray nozzle is the nasopharynx.

18. A nasal spray / spray nozzle according to any one of claims 1 to 15, wherein the target area to be sprayed / sprayed by the nasal spray / spray nozzle is the olfactory region.

19. An upward pressure airless type spray / spray device comprising a nasal spray / spray nozzle according to any one of claims 1 to 18.

20. A syringe-type spray / spray device comprising a nasal spray / spray nozzle according to any one of claims 1 to 13 and 16 to 18.

21. The syringe-type spray / injection device according to claim 20, wherein the syringe body to which the nasal spray / injection nozzle is attached has a finger rest.

22. The syringe type spray / spray device according to claim 21, wherein the major axis direction of the nose rest and the major axis direction of the finger rest are substantially perpendicular to each other when viewed from above.

23. A nasal spray rest product comprising a nose rest that can be brought into contact with the periphery of the external nostrils and a finger rest for placing the fingers, said nasal spray rest product being attached to a spray / spray device.