nozzle

Abstract

The present invention relates to an improved nozzle (1) for a squeeze-operated intranasal device for administering a substance, such as a drug-containing liquid, into a target nasal cavity. The nozzle comprises a body that is generally truncated oblique cone in shape. The base (7) of the nozzle is substantially annular and has a first central axis (2). The upper end of the nozzle has a substantially circular surface (3) having a second central axis (4). The substantially circular surface and the substantially annular base are parallel to each other. The outer diameter of the substantially annular base is greater than the outer diameter of the substantially circular surface, the second central axis at the upper end is parallel to and eccentric with respect to the first central axis of the base, and the surface of the body is smoothly tapered from the base to the upper end.

Description

Technical Field

[0001] The present invention relates to an improved nozzle for a squeeze-operated nasal device.

Background Art

[0002] The use of nasal spray devices for delivering aerosolized liquids and powders into the nasal cavity of a subject is well known. Typically, a nasal spray has a small bottle or container filled with a liquid or powder, such as a drug, and a nozzle.

[0003] Many nasal sprays have a pressurized container that releases the contents when the user presses down on the nozzle with a downward force. However, the action required to press down on the nozzle requires a greater force, and the nozzle may slip or move during use, resulting in incorrect dosing or injury. Other nasal sprays have a non-pressurized container, which requires the user to squeeze the container to release the contents. Also, due to the nature of this device, the user may place the nozzle in an incorrect position, resulting in inadequate dosing to the inappropriate part of the nose and often swallowing the contents when they reach the throat. These problems can be exacerbated by differences between different users regarding the ability to squeeze the container.

[0004] An improved nozzle for a nasal dispenser is disclosed in International Publication No. 2004 / 1108197.

[0005] Despite the improvements, many users are still unaware that using a nasal spray inaccurately can result in waste, inaccurate or ineffective dosing, and a risk of nasal injury. Therefore, in order to mitigate these issues, further innovation in this field is still required, particularly with respect to squeeze-type nasal dispensers.

Summary of the Invention

[0006] In the first embodiment, the device comprises a truncated oblique cone-shaped body having a substantially annular base having a first central axis and a substantially circular surface having a second central axis at its upper end, a discharge port located substantially inside the circular surface at the upper end of the body, and a channel extending through the nozzle and defining a passage for fluid communication with the substantially annular base and the discharge port, wherein the outer diameter of the substantially annular base is greater than the outer diameter of the substantially circular surface, and the second central axis at the upper end is parallel to and eccentric with respect to the first central axis of the base. The main body has a surface that tapers smoothly from the base to the top, the main body is symmetrical with respect to a plane of symmetry, the main body has a longest and shortest generatrix, the generatrixes are coplanar with respect to the plane of symmetry, the shortest generatrix is ​​a substantially straight line parallel to a second central axis, and the longest generatrix is ​​a concave line that slopes such that the surface of the nosepiece smoothly changes from a substantially flat shape to a concave shape around the second central axis, and is equipped with a nozzle for intranasal administration of liquid from a squeeze-operated device.

[0007] In particular, the substantially annular base has a shoulder portion configured to abut against the surface of the container. In one embodiment, the shoulder portion configured to abut against the surface of the container is the surface of an annular rim projecting downward. In one embodiment, the shoulder portion configured to abut against the surface of the container is the surface of an annular flange extending radially outward in a direction substantially perpendicular to a first central axis.

[0008] In particular, the nozzle further comprises a substantially cylindrical skirt portion extending downward from a substantially annular base and configured for attachment to a container. In some embodiments, the substantially cylindrical skirt portion extends downward from an internal position within the shoulder portion and is configured to engage with the inside of the neck portion of the container. In some embodiments, the substantially cylindrical skirt portion has at least one annular grip rib on its outer surface for sealing and / or gripping engagement with the inner surface of the neck portion of the container.

[0009] In particular, the transition between the nosepiece surface and the substantially circular surface is a chamfered corner.

[0010] In some embodiments, the discharge port is coaxial with the second axis of the circular surface. In other embodiments, the discharge port is eccentric with respect to the second axis of the circular surface.

[0011] In particular, the nozzle has a substantially circular raised edge that extends upward from a substantially circular surface around the discharge port.

[0012] In particular, the nozzle includes an immersion tube having a liquid inlet and a liquid outlet that hang down from the outlet, in order to guide the liquid upward from the container to the outlet.

[0013] In some embodiments, the nozzle may further comprise at least one air channel defining a passage for directing air from inside the main body or from the top of the container to which it is attached to a liquid outlet and discharge port to at least one orifice that is in fluid communication with the liquid outlet and discharge port during use. In particular, at least one orifice is located around the liquid outlet of the immersion tube. In some embodiments, the nozzle comprises two air channels and two orifices arranged circumferentially around the immersion tube. In particular, the air released from the orifices is released at an angle of 0 to 90 degrees with respect to the direction of movement of the liquid toward the discharge port. In some embodiments, the inner wall of at least one air channel is defined and bounded by the outer wall of the immersion tube.

[0014] In a second aspect of the present invention, a squeeze-operated device for intranasal administration of liquid is provided, comprising a container having at least one flexible wall and defining an internal volume for holding liquid, and a nozzle as described in the first aspect.

[0015] In some embodiments, a squeeze-operated device for intranasal administration of liquid is provided, comprising a container having an internal volume for holding liquid, having at least one flexible wall and a neck portion having an opening with an internal surface, and a nozzle as described in the first embodiment, wherein a friction-fit connection is formed between the container and the nozzle by the engagement of the outer surface of a substantially cylindrical skirt portion with the inner surface of the neck portion.

[0016] In particular, the squeeze-operated device further includes a liquid. More specifically, the liquid is a liquid formulation of a pharmaceutical active ingredient. In one embodiment, the liquid is physiological saline. In one embodiment, the liquid is a liquid formulation containing an imidazoline nasal vasoconstrictor. In one embodiment, the liquid formulation contains xylometazoline or oxymetazoline. Preferably, the liquid formulation contains oxymetazoline. [Brief explanation of the drawing]

[0017] [Figure 1] Figure 1 is a schematic diagram of a generalized nozzle shape (oblique cone prism). The base of the nozzle (1) is substantially annular and has a central axis (2). The upper end of the nozzle has a substantially circular surface (3) and also has a central axis (4). The outer diameter of the substantially annular base (7) is larger than the outer diameter of the substantially circular surface (8), the second central axis (4) at the upper end is parallel to and eccentric with respect to the first central axis (2) of the base, and the surface of the main body is smoothly tapered from the base to the upper end. The nozzle body is symmetrical with respect to the plane of symmetry and has the longest generatrix (9) and the shortest generatrix (10), which are coplanar with the plane of symmetry. [Figure 2] Figure 2 shows a perspective view of one embodiment of a nozzle comprising an annular flange (13) and a substantially cylindrical skirt portion (14), further comprising an annular grip rib (15). [Figure 3] Figure 3 shows a perspective view of one embodiment of a nozzle, which has a substantially circular raised edge (17) extending upward from a substantially circular surface (3) at the upper end. [Figure 4(a)]Figure 4(a) shows a cross-sectional view of the nozzle described in Figure 3. [Figure 4(b)] Figure 4(b) shows a plan view of the nozzle described in Figure 3. [Figure 5] Figure 5 is a perspective cross-sectional view of the nozzle shown in Figure 3. [Figure 6] Figure 6 shows a perspective view of a further embodiment of a nozzle without an annular flange. [Figure 7] Figure 7 shows a perspective view of one embodiment of a nozzle that does not have an annular flange and has a substantially circular raised edge (17) extending upward from a substantially circular surface (3) at the upper end. [Figure 8(a)] Figure 8(a) shows a cross-sectional view of the nozzle described in Figure 7. [Figure 8(b)] Figure 8(b) shows a plan view of the nozzle described in Figure 7. [Figure 9] Figure 9 is a perspective cross-sectional view of the nozzle shown in Figure 7. [Figure 10(a)] Figure 10(a) shows one embodiment of a nozzle in use, which comprises two air channels and two orifices arranged circumferentially (180 degrees apart) around an immersion tube nozzle. Air is introduced from inside the nozzle body and / or from the headspace of the container and mixed with the liquid introduced upward from the container. An enlarged view of the inside of the nozzle is shown, indicating the direction of the airflow and liquid, and the angle (a) at which the air is released from the air channels into the liquid towards the outlet. [Figure 10(b)] Figure 10(b) shows one embodiment of a nozzle in use, which comprises two air channels and two orifices arranged circumferentially (180 degrees apart) around an immersion tube nozzle. Air is introduced from inside the nozzle body and / or from the headspace of the container and mixed with the liquid introduced upward from the container. An enlarged view of the inside of the nozzle is shown, indicating the direction of the airflow and liquid, and the angle (a) at which the air is released from the air channels into the liquid toward the outlet. [Modes for carrying out the invention]

[0018] For effective nasal delivery, the spray must be directed towards the sides of the nose rather than the nasal septum. For this purpose, the nozzles in the prior art need to be angled towards the rear and side of the human user so that the ejection path is optimally directed. However, since this is usually felt to be uncomfortable, without proper guidance, the user will direct the nozzle upwards and the spray will be ejected into the front region inside the nasal cavity.

[0019] The inventors have developed a nozzle incorporating a positioning indicator that unconsciously conveys the appropriate position and alignment to the user. The squeeze-operated nasal sprays in the prior art are often operated using ipsilateral techniques (using the hand on the same side of the nostril and the body) that can cause misuse and nosebleeds (Ganesh, V., Banigo, A., McMurran, A., Shakeel, M., & Ram, B. (2017) The Journal of Laryngology & Otology, 131(11), 991-996). In contrast to the prior art devices, the improved nozzle of the present invention can promote the use of contralateral spray techniques to overcome this problem. In addition, the improved nozzle has the features of preventing it from being inserted too deeply into the nostril, stabilizing and holding it in a predetermined position while squeezing and ejecting the nozzle, and preventing accidental injuries. The improved nozzle also enhances user comfort as it does not have sharp edges or pointed surfaces. Surprisingly, the nozzle has no moving parts and can also be easily manufactured as a single part by injection molding.

[0020] The nozzle in the present invention is used for the intranasal administration of liquid from a squeeze-operated container such as a bottle. The squeeze operation is known as a technique in which a container formed of an elastically deformable material is grasped by hand, bringing the substantially opposing portions of the container side walls closer to each other and increasing the internal pressure. This increase in internal pressure causes the liquid to be extruded from the container through the nozzle into the nasal cavity. Incidentally, the squeeze-operated container is a non-pressurized container and does not contain a propellant, a propellant gas, or a compressed gas as used in, for example, an aerosol.

[0021] The nozzle in the present invention comprises a truncated oblique conical body portion (oblique truncated cone) (see FIG. 1, which is a schematic view emphasizing the features mentioned below). The base of the nozzle (1) is substantially annular and has a central axis (2) referred to as the first central axis. The upper end of the nozzle has a substantially circular surface (3) and also has a central axis (4) referred to as the second central axis. The phrases "substantially annular" and "substantially circular" here include circular or circular shapes, but may also include elliptical shapes that are not perfectly circular. The substantially circular surface and the substantially annular base are parallel to each other. The outer diameter of the substantially annular base (7) is larger than the outer diameter of the substantially circular surface (8), and the second central axis (4) at the upper end is parallel to and eccentric with respect to the first central axis (2) of the base, and the surface of the body portion is smoothly tapered from the base towards the upper end. Thus, the cross-sectional area of the nozzle decreases from the base towards the upper end.

[0022] The surface of the nozzle is a complex three-dimensional geometric shape generated by connecting lines from each point around the substantially annular base to a virtual single apex above the substantially circular surface. Each line segment from the outer periphery of the substantially annular base to the intersection with the substantially circular surface is called a generatrix, particularly a generatrix of the side surface.

[0023] The nozzle body is symmetrical with respect to the plane of symmetry and has a longest generatrix (9) and a shortest generatrix (10), which are coplanar with the plane of symmetry. The shortest generatrix is ​​a substantially straight line, such as a straight line, and substantially parallel to the second central axis. In the context of the present invention, the term “substantially parallel to the second central axis” is intended to include not only parallel lines but also lines that deviate from the second central axis at small angles of about 10 degrees or less, for example, in the range of about 1 to about 10 degrees. In some embodiments, the shortest generatrix has an angle of 5 to 10 degrees with respect to the second central axis. For example, it may be an angle of 5.0, 6.0, 7.0, 8.0, 9.0, or 10.0 degrees, or even 5.3 or 9.7 degrees. The longest generatrix is ​​an inclined concave line. As a result, from the shortest to the longest generatrix, the surface of the nosepiece smoothly changes from a substantially flat shape to a concave shape around the second central axis.

[0024] At the upper end of the nozzle body, a discharge port (5) is located inside a substantially circular surface (3) from which liquid can be discharged. The discharge port can be of any shape, but is usually substantially circular. Channels or conduits (6) extend through the nozzle and define passages that communicate fluidly with the substantially annular base and discharge port. In particular, the nozzle may be hollow inside, and channel or conduit structures may be formed inside the cavity.

[0025] In some embodiments of the present invention, the substantially annular base has a shoulder portion configured to abut against the surface of the container (see, for example, (11) in Figure 4(a) and (11) in Figure 8(a). In particular, the shoulder portion configured to abut against the surface of the container is the surface of an annular rim projecting downward ((12) in Figure 4(a) and (12) in Figure 8(a)).

[0026] In some embodiments of the present invention, the shoulder portion configured to abut the surface of the container is the surface of an annular flange ((13) in Figure 2) extending radially outward in a direction substantially perpendicular to the first central axis.

[0027] In particular, the nozzle of the present invention further comprises a substantially cylindrical skirt portion (14) that extends downward, particularly axially, from a substantially annular base and is configured for attaching the nozzle to a container.

[0028] In some embodiments, a substantially cylindrical skirt portion is configured to extend downward from its position within the shoulder portion and engage with the inside of the neck portion of the container. The engagement may be achieved by "interference fitting," i.e., by the outer dimensions of one part slightly exceeding the inner dimensions of the other part into which it fits, or by "friction fitting," i.e., by friction that occurs after the parts have been joined together.

[0029] The term “snap-fit” is used to describe an engaging means in which one part has one or more projections that snap into one or more recesses on a second part, thereby joining the two parts together. In particular, a substantially cylindrical skirt portion has at least one annular grip rib (15) on its outer surface to seal and / or grip-engage with the inner surface of the neck portion of the container. More specifically, a substantially cylindrical skirt portion has at least one annular grip rib on its outer surface to seal and / or grip-engage with at least one annular recess provided on the inner surface of the neck portion of the container (see Figure 10(a) as an example).

[0030] The term “screw-fit” is used to describe a joining means in which two parts are reversibly joined by screwing them together, with one part having helical, i.e., forward-moving helical threads and the other part having helical grooves corresponding to the same size and number of threads. In some embodiments, a substantially cylindrical skirt portion extends downward from its position inside the shoulder portion and is configured to engage with the outside of the neck portion of the container. For example, the substantially cylindrical skirt portion has helical grooves on its inner surface to tightly and / or grip-engage with the corresponding helical threads on the outer surface of the neck portion of the container.

[0031] The nozzle must be comfortable for the user when inserted into the nostril. In particular, the transition between the side of the nozzle and the substantially circular surface is a smooth transition, preferably a chamfered corner (16).

[0032] In one embodiment, the discharge port is substantially coaxial with the second axis of the circular surface. In another embodiment, the discharge port is substantially eccentric with respect to the second axis of the circular surface.

[0033] The nozzle may have a substantially circular raised edge (17) extending upward from a substantially circular surface around the discharge port. The presence of such a raised edge can be advantageous in preventing the discharge port from becoming clogged during use. The edge may also engage with a seal, such as a cap, to prevent leakage from the device when it is not in use. In some embodiments, the substantially circular surface may have a recessed portion surrounding the discharge port, i.e., the discharge port may be formed in a countersunk shape within the surface. The walls of the recessed portion are preferably inclined, and may be curved, especially concave.

[0034] The nozzle may be connected to an immersion tube (18), one end of which is connected to a discharge port, and the other end which is open adjacent to the base of the container during use. Thus, the nozzle may include an immersion tube that extends through the nozzle and forms part or all of a channel or conduit that defines a passage for fluid communication with a substantially annular base and a discharge port. The immersion tube has a liquid inlet and a liquid outlet. More specifically, the nozzle may include an immersion tube for directing liquid upward from the bottom of the container to the discharge port. Even more specifically, for directing liquid upward from the container, particularly the bottom of the container, to the discharge port, the immersion tube may be attached to the discharge port and may also hang down. In some embodiments, the liquid outlet of the immersion tube may be attached to the nozzle by friction fitting and / or adhesive, or the connection may be further improved using other binders.

[0035] The nozzle further comprises at least one air channel that defines a passage for directing air from the inside of the nozzle body and / or the headspace of the container to at least one orifice that fluidly communicates with the liquid outlet and discharge port (Figure 10(a)(6), Figure 10(b)(6)). During use, the air directed from the inside of the nozzle body and / or the headspace of the container mixes with the liquid directed upward from the container (see, for example, Figure 10(b)). This air helps to promote the splitting of the liquid to form droplets, while also helping to direct the spray to the back of the nose.

[0036] In particular, at least one orifice is positioned around the liquid outlet of the immersion tube. In some embodiments, the nozzle includes two air channels and two orifices circumferentially arranged around the immersion tube. In other embodiments, the nozzle includes three air channels and three orifices circumferentially arranged around the immersion tube. In yet another embodiment, the nozzle includes four air channels and four orifices circumferentially arranged around the immersion tube. In particular, the air released from the orifices is released at an angle of 0 to 90 degrees (a) with respect to the direction of liquid movement toward the outlet (Figure 10(b)(a)). More specifically, the air released from the orifices is released at an angle of 45 to 90 degrees with respect to the direction of liquid movement toward the outlet, for example, 45, 50, 55, 60, 65, 70, 75, 80, 85 or 90 degrees. Even more specifically, the air released from the orifices is released at an angle of approximately 90 degrees with respect to the direction of liquid movement toward the outlet. In one embodiment, the air released from the orifice may be released at an angle of 85 to approximately 90 degrees with respect to the direction of liquid movement toward the outlet, for example, 85, 86, 87, 88, 89, or 90 degrees. In another embodiment, the air released from the orifice may be released at an angle greater than 90 degrees with respect to the direction of liquid movement toward the outlet, for example, 91 to 100 degrees, for example, 91, 92, 93, 94, 95, 96, 97, 98, 99, or 100 degrees. In yet another embodiment, the air released from the orifice may be released at an angle of 85 to 95 degrees with respect to the direction of liquid movement toward the outlet.

[0037] In particular, the inner wall of at least one air channel is defined and bounded by the outer wall of the immersion tube (see Figures 10(a) and (b)).

[0038] In particular, the nozzle is injection molded as a single component made of thermoplastic resin material. More specifically, the nozzle is injection molded as a single component made of low-density polyethylene (LDPE). In some embodiments, the immersion tube is an integral part of the nozzle. In other embodiments, the main body of the nozzle is injection molded as a single component made of LDPE, and the immersion tube is a separate component joined in a further processing step.

[0039] The nozzle in this invention is for attachment to a squeeze-operated container or bottle. The squeeze container is usually formed from an elastically deformable and flexible material so that when the container wall is deformed, the contents of the container, usually a liquid, are pushed up the immersion tube to the nozzle and discharged from the outlet. Preferably, the container can be easily deformed by squeezing it with one hand. Typically, the container has two deformable areas that are positioned opposite each other to facilitate gripping the bottle by hand. The deformability of the container may be limited to at least two predetermined areas. As a result, even if other areas of the container are pressed, no liquid is ejected. The container may be formed by any suitable method such as thermoforming, blow molding, injection molding, or injection stretch blow molding. Preferably, the container is formed by blow molding. More preferably, the container is formed by blow molding from LDPE.

[0040] Thus, a squeeze-operated device for intranasal administration of liquid is also provided, comprising a container having at least one flexible wall and defining an internal volume for holding liquid, and the nozzle of the present invention as described above. In some embodiments, the squeeze-operated device for intranasal administration of liquid comprises a container having at least one flexible wall and a neck portion having an opening with an inner surface, defining an internal volume for holding liquid, and the nozzle of the present invention, wherein a friction-fit connection is formed between the container and the nozzle by the engagement of the outer surface of a substantially cylindrical skirt portion with the inner surface of the neck portion. A sealing cap may be further provided, which is screwed onto the neck portion of the container so as to cover the nozzle. Preferably, the sealing cap is made of high-density polyethylene (HDPE).

[0041] The squeeze-operated device of the present invention is particularly suitable for use with commercially available (OTC) liquid formulations. Thus, the squeeze-operated device further comprises a liquid, more specifically a liquid formulation. The liquid and liquid formulation are preferably pharmaceutically acceptable. The liquid formulation may contain a pharmaceutically active ingredient (API). In one embodiment, the API is an imidazoline nasal vasoconstrictor. In one embodiment, the liquid formulation contains xylometazoline or oxymetazoline. Preferably, the liquid formulation contains oxymetazoline. In another embodiment, the liquid is physiological saline or sterile water.

[0042] The container includes headspace above the liquid. As used herein, the term “headspace” typically refers to the area inside the container above the water level of any liquid contained within it. In the context of this invention, headspace is air space, particularly filled with air, and more specifically, air in the atmosphere.

[0043] During use, manual squeezing of the container causes the normally opposite portions of the deformable container sidewalls to move closer together, increasing the internal pressure. Because there is an air-containing headspace above the liquid, squeezing the opposite portion of the container sidewall reduces the container's internal volume, generating internal pressure that pushes the air towards the discharge path with the least resistance. This internal pressure also pushes the liquid towards the discharge path with the least resistance. Thus, this increase in internal pressure creates both an airflow in the air channel and an upward flow of liquid through the immersion tube (Figure 10(a)). These airflows and liquid flows combine and are pushed out of the outlet, resulting in a spray of liquid from the nozzle, administering a fixed amount of atomized liquid into the nasal cavity (Figure 10(b)). When the squeezing force on the container is released, the container returns to substantially its original shape. This creates an internal suction force, drawing air into the container until the internal pressure returns to roughly atmospheric pressure.

[0044] General matters The term “composed of” encompasses “containing,” and for example, if a composition “composed of” X, it may also contain Y in addition to X. In some embodiments, the term “composed of” refers not only to the inclusion of a specified active ingredient such as the described polypeptide, but also to the inclusion of other active ingredients, as well as pharmaceutically acceptable carriers, excipients, emollients, stabilizers, etc., that are well known in the pharmaceutical industry. In some embodiments, the term “essentially composed of” refers to a composition having only the indicated active ingredient as an active ingredient, such as ibuprofen arginine salt. However, other compounds that do not directly contribute to the therapeutic effect of the indicated active ingredient may be included for purposes such as stabilizing or preserving the formulation. The use of the transitional phrase “essentially composed of” means that the scope of the claim is to be interpreted as encompassing specific materials and processes described in the claim, and those that do not substantially affect the basic and novel properties of the claimed invention. See In re Herz, 537 F.2d 549, 551-52, 190 USPQ 461, 463 (CCPA 1976) (emphasis added). See also MPEP §2111.03. Thus, the term “essentially composed of” as used in the claims of the present invention is not intended to be construed as synonymous with “composed of.” The term “composed of” and its variations mean including and being limited to (for example, the specified components or processes). In certain areas, the expression “composed of an active ingredient composed of” may be used instead of “essentially composed of.” The term “about” with respect to the numerical value x is optional and means that the numerical value has a certain range of variation around the specified value, for example, to account for steady experimental variation or measurement error, or to include minor deviations (e.g., x±10%, x±5%, x±4%, x±3%, x±2%, x±1%) that may yield results substantially equivalent to the given numerical value. The word “substantially” does not exclude “completely”; for example, a composition “substantially does not contain” Y may not contain Y at all. Where necessary, the word “substantially” may be omitted from the definition of the invention.If the method refers to process steps such as (a), (b), and (c), these are intended to be performed sequentially, that is, step (c) follows step (b), and step (b) precedes step (a).

[0045] All references or patent applications cited herein are incorporated herein by reference. To better illustrate this invention, the following examples are provided. These examples are for illustrative purposes only and do not limit the scope of the invention in any way.

[0046] Examples Figures 2 to 5 show two modifications of the “friction-fitting” nozzle according to the present invention, both of which are equipped with an annular flange (13) at the base. The nozzle in Figure 2 is equipped with a substantially annular base (1) equipped with an annular flange (13) having a central axis (2). The upper end of the nozzle has a substantially circular surface (3) and also has a central axis (4). The chamfered corner (16) is a smooth transition from the outer surface to the upper end. The nozzle's spray outlet (5) is located in a recess of the surface at the substantially circular upper end. As can be seen from the figure, the body is tapered from the base to the upper end, with the outer diameter of the base being larger than the outer diameter of the surface at the upper end. In this embodiment, the nozzle is equipped with a substantially cylindrical skirt portion (14) having an annular grip rib (15) for engaging with the neck portion of a container (not shown). Figure 3 is a further modification equipped with a substantially circular raised edge (17) extending upward from the substantially circular surface around the recessed outlet. The presence of this raised edge prevents the outlet from becoming clogged during use. This edge is also designed to engage with a sealing component within the cap (not shown), preventing leakage from the assembled device when not in use. Figure 4(a) is a cross-sectional view of the nozzle showing the shoulder portion (11) that abuts against the surface of a container (not shown). Part of the immersion tube is shown extending from the outlet (5) through part of the channel (6). Figure 4(b) is a view of the nozzle from below, showing two internal reinforcing supports appearing as two rectangles at the 0 and 180-degree positions. Two air channels are also located above and below the outlet (5). Figures 6 to 9 are two further variations of the nozzle without the annular flange described above.

[0047] Figure 10(a) is a cross-sectional view of the nozzle of the present invention, attached to the neck of a container (the entire container is not shown). During use, manual squeezing of the container causes the opposite sides of the container's sidewalls to move closer together, increasing the internal pressure. Because there is a headspace containing air above the liquid, when the opposite sides of the container's sidewalls are squeezed, the internal volume of the container decreases, generating internal pressure that pushes the air through the discharge path with the least resistance. This internal pressure also pushes the liquid through the discharge path with the least resistance. This increase in internal pressure creates an airflow in the air channel (indicated by the arrow) and an upward flow of liquid through the immersion tube (18). These airflows and liquid flows intersect and combine, pushing out from the outlet, resulting in a spray of liquid from the nozzle, administering a fixed amount of atomized liquid into the nasal cavity (Figure 10(b)). When the squeezing force on the container is released, the container returns to substantially its original shape. This creates an internal suction force, drawing air into the interior until the internal pressure returns to roughly atmospheric pressure.

Claims

1. A nozzle for intranasal administration of liquid from a squeeze-operated device, A truncated oblique cone-shaped main body having a substantially annular base having a first central axis and a substantially circular surface at its upper end having a second central axis, At the upper end of the main body, a discharge port is located inside the substantially circular surface, The nozzle comprises a channel that extends through the nozzle and defines a passage that communicates fluid with the substantially annular base and the discharge port, The outer diameter of the substantially annular base is larger than the outer diameter of the substantially circular surface, the second central axis at the upper end is parallel to and eccentric with respect to the first central axis of the base, and the surface of the main body is smoothly tapered from the base to the upper end. The main body is symmetrical with respect to the plane of symmetry, and has the longest and shortest generatrix, and the generatrixes are on the same plane as the plane of symmetry. A nozzle in which the shortest generatrix is ​​a substantially straight line parallel to the second central axis, and the longest generatrix is ​​a concave line inclined such that the surface of the nosepiece smoothly changes from a substantially flat shape to a concave shape around the second central axis.

2. The nozzle according to claim 1, wherein the substantially annular base has a shoulder portion configured to contact the surface of a container.

3. The nozzle according to claim 2, wherein (i) the shoulder portion configured to contact the surface of the container is the surface of an annular rim projecting downward, or (ii) the shoulder portion configured to contact the surface of the container is the surface of an annular flange extending radially outward in a direction substantially perpendicular to the first central axis.

4. The nozzle according to claim 2 or 3, further comprising a substantially cylindrical skirt portion extending downward from the substantially annular base and configured for attachment to a container.

5. The nozzle according to claim 4, wherein the substantially cylindrical skirt portion extends downward from its position inside the shoulder portion and is configured to engage with the inside of the neck portion of the container.

6. The nozzle according to claim 5, wherein the substantially cylindrical skirt portion has at least one annular grip rib on its outer surface for sealing and / or gripping the inner surface of the neck portion of the container.

7. The nozzle according to any one of the preceding claims, wherein the transition between the surface of the nosepiece and the substantially circular surface is a chamfered corner.

8. (i) the discharge port is coaxial with the second axis of the substantially circular surface, or (ii) the discharge port is eccentric with respect to the second axis of the substantially circular surface, according to claim 7.

9. The nozzle according to any one of the preceding claims, comprising a substantially circular raised edge extending upward from the substantially circular surface around the discharge port.

10. The nozzle according to claim 8 or 9, further comprising an immersion tube having a liquid inlet and a liquid outlet hanging down from the outlet, for guiding the liquid upward from the container to the outlet.

11. The nozzle according to claim 10, further comprising at least one air channel that defines a passage for guiding air from the inside of the main body to at least one orifice that is in fluid communication with the liquid outlet and the discharge port, wherein during use, the air guided from the inside of the main body mixes with the liquid guided upward from the container.

12. The nozzle according to claim 11, wherein the at least one orifice is positioned around the liquid outlet of the immersion tube.

13. The nozzle according to claim 11 or 12, comprising two air channels and two orifices arranged circumferentially around the immersion tube.

14. The nozzle according to claim 11, 12, or 13, wherein the air discharged from the orifice is discharged at an angle of 0 to 90 degrees, particularly 45 to 90 degrees, with respect to the direction of movement of the liquid toward the discharge port.

15. The nozzle according to any one of claims 11 to 14, wherein the inner wall of the at least one air channel is defined and bounded by the outer wall of the immersion tube.

16. A squeeze-operated device for administering liquids into the nasal cavity, A container having at least one flexible wall and defining an internal volume for holding the liquid, A squeeze-operated device comprising a nozzle according to any one of claims 1 to 15.

17. A squeeze-operated device for administering liquids into the nasal cavity, A container having at least one flexible wall and a neck portion having an opening with an inner surface, defining an internal volume for holding the liquid, A nozzle according to any one of claims 4 to 15, comprising A squeeze-operated device in which a friction-fit connection is formed between the container and the nozzle by the engagement of the outer surface of the substantially cylindrical skirt portion and the inner surface of the neck portion.

18. The squeeze-operated device according to claim 16 or 17, further comprising a liquid, specifically a liquid formulation of a pharmaceutical active ingredient, more specifically a liquid formulation containing oxymetazoline or physiological saline.

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