Spray assembly and nasal spray apparatus

Abstract

The present application provides a spray assembly and a nasal spray apparatus. The spray assembly comprises a spray head and a vortex portion accommodated in the spray head. A spray hole is arranged at the far end of the spray head. The vortex portion comprises a vortex cavity in communication with the spray hole and a vortex groove in communication with the vortex cavity. The vortex groove comprises a first flow-guiding surface and a second flow-guiding surface that are arranged opposite to each other. The second flow-guiding surface is tangent to a cavity wall of the vortex cavity. The included angle α between the first flow-guiding surface and the second flow-guiding surface is 14-30°. The diameter of the vortex cavity is 0.5-2.0 mm. In the spray assembly of the present application, arranging the vortex portion in the spray head enables the drug, when flowing through the vortex portion, to form a vortex and to be pressurized and accelerated, and limiting structural parameters of the vortex portion enables the sprayed drug to achieve a predetermined spray angle and spray particle size, thereby avoiding a situation where the spray angle or particle size is so large that the drug is excessively deposited on the wall of the nasal vestibular cavity, avoiding a situation where the spray angle is so small that a mist cannot be formed, and avoiding a situation where the spray particle size is so small that the drug enters the lungs, which raises safety concerns.

Description

Spray assembly and nasal spray device TECHNICAL FIELD

[0001] The present application relates to a spray assembly and a nasal spray device, and belongs to the field of medical instruments. BACKGROUND

[0002] In recent years, the number of people suffering from central nervous system diseases (such as epilepsy, depression, Alzheimer's disease, etc.) has been increasing year by year. However, the success rate of new drug development is much lower than market demand. The main reason is that the blood-cerebrospinal fluid barrier, brain-cerebrospinal fluid barrier and blood-brain barrier (Blood-Brain-Barrier) three physiological barriers limit the drug to enter the lesion site through blood circulation to play the role of drug efficacy. However, although the current drug can be administered by direct injection into the brain ventricle or thin-walled tissue of the brain to improve the effective concentration of the drug in the brain tissue, this invasive administration method is only suitable for acute / urgent treatment, which has high risk and poor compliance. Therefore, the development of a non-invasive drug delivery method with high brain enrichment efficiency has a high value for the treatment of central nervous system diseases and drug development.

[0003] In recent years, the nasal cavity into the brain route has become a potential method to solve the problem of non-invasive brain delivery. A large number of studies have confirmed that drugs can bypass the BBB (Blood-Brain-Barrier) into the brain tissue through the olfactory nerve and trigeminal nerve in the nasal cavity. However, based on the physiological structure of the nasal cavity, it can be observed that the olfactory nerve and a large number of trigeminal nerves exist in the superior nasal meatus region of the nasal cavity, but the existence of the nasal valve structure limits the deposition of drugs in the superior nasal meatus. Therefore, how to deliver drugs to the superior nasal meatus region is the key technology to realize the nasal brain delivery.

[0004] The physiological structure of the nasal vestibule based on the human nasal cavity is relatively special. There is a nasal septum protruding structure between the nasal valve and the superior meatus, which causes the channel to be very narrow at this point, and the shape and size of the channel vary greatly among different patients, hindering the enrichment of drugs to the superior meatus. Aptar, the current leading supplier of nasal delivery devices, claims to have a nasal delivery device that can achieve a superior meatus delivery efficiency of up to 50% or more, but this device only obtains data in its in vitro model and has not reported any clinical data. In addition, the prior art also proposes to extend the length of the spray head inserted into the nasal cavity to approach the olfactory region and achieve olfactory region drug delivery. For example, Chinese Patent No. CN 202320634030.2, but practical exploration has proved that the excessively long nasal spray head cannot make the drug truly reach or effectively deposit in the olfactory region due to the obstruction of the nasal septum, and may even cause undesirable discomfort and even tissue damage to the nasal septum. Some existing literature also proposes to set a vortex generator at the spray head to make the drug liquid become a vortex before being sprayed, thereby increasing the spray angle of the drug and making the drug more uniform. For example, Chinese Patent No. CN 202080062099.1, however, this device relies on a nasal support to change the spray direction of the drug to achieve precise delivery to the target area (such as the olfactory region, nasopharynx region, respiratory region, etc.). However, due to the complexity and variability of the human nasal cavity structure, a single change in the spray direction does not have universal applicability and clinical feasibility in actual application.

[0005] The inventors have found that the spray angle of the drug varies in size and the particle size range varies greatly when using existing nasal spray devices. When the spray angle is too large or the particle size is too large, most of the drug will directly contact and adhere to the nasal wall, or will easily deposit in the nasal cavity at the spray hole after being sprayed; when the spray angle is too small or the particle size is too small, the drug will easily enter the throat and lungs; all of which result in most of the drug not being able to accurately reach the target area (such as the olfactory region of the superior meatus). In addition, the inventors have also found that the drug deposition rate in the olfactory region of the superior meatus is generally low when using existing spray heads for olfactory region drug delivery, which cannot form effective drug deposition, so as to fail to achieve effective nasal brain delivery effect.

[0006] Therefore, it is necessary to improve the existing nasal spray device to solve the above problems. SUMMARY

[0007] The purpose of the present disclosure is to provide a spray assembly and a nasal spray device to solve any one of the problems of the existing nasal spray device, such as the spray angle varying in size, the particle size range of the spray varying greatly, and the deposition rate in the olfactory region of the superior meatus being low.

[0008] To achieve the above object, the application provides a spraying assembly, comprising a nozzle and a vortex part accommodated in the nozzle, a spray hole is arranged at a distal end of the nozzle, the vortex part comprises a vortex cavity communicated with the spray hole and a vortex groove communicated with the vortex cavity, the vortex groove comprises oppositely arranged first and second flow guide surfaces, the second flow guide surface is tangent to a cavity wall of the vortex cavity, an included angle a between the first and second flow guide surfaces is 14-30°, and a diameter of the vortex cavity is 0.5-2.0 mm. Preferably, the included angle a is 18-26°, more preferably, the included angle a is 22-26°, and preferably, the diameter of the vortex cavity is 1.0-1.5 mm. By limiting the included angle a between the first and second flow guide surfaces and the diameter of the vortex cavity, the vortex part can accelerate the drug and make the flow state of the drug become vortex, so that the shape of the drug when sprayed has a target spray angle and the sprayed drug reaches a target particle size range, in other words, by limiting the included angle a between the first and second flow guide surfaces to 14-30° and the diameter of the vortex cavity to 0.5-2.0 mm, the spray angle of the drug when sprayed reaches 15-40°, and the particle size range D90 is between 80-130 μm.

[0009] As a further improvement of the application, a distance between an end of the vortex groove away from the vortex cavity and an axis of the spray hole is 0.75-1.375 mm; and / or, a diameter of the spray hole is 0.15-0.22 mm, preferably 0.15-0.2 mm or 0.2-0.22 mm; and / or, a thickness of the spray hole is 0.15-0.25 mm, preferably 0.15-0.2 mm or 0.2-0.22 mm; and / or, a thickness of the vortex groove is 0.1-0.25 mm, preferably 0.15-0.25 mm; and / or, the vortex groove is arranged in a constricted manner in a direction towards the vortex cavity, so that the sprayed drug has more stable properties.

[0010] As a further improvement of the application, the vortex groove further comprises an arc-shaped annular surface smoothly connected with the second flow guide surface, the annular surface surrounds the vortex cavity or an end of the annular surface away from the second flow guide surface extends into the vortex cavity, the vortex cavity is arranged in the same plane as the vortex groove, and the vortex groove is provided with at least one. After the drug is guided to the annular surface through the second flow guide surface, the flow direction of the drug is controlled through the annular surface, so that the drug flows in a spiral manner in the vortex cavity after passing through the annular surface. The arc shape of the annular surface can be the same as the arc shape of the cavity wall of the vortex cavity, that is, the radius of the annular surface is the same as the radius of the vortex cavity; the radius of the arc shape of the annular surface can also be smaller than the radius of the vortex cavity, so as to control the flow direction of the drug and shorten the path of the drug flowing to the spray hole.

[0011] As a further improvement of the application, the vortex part further comprises a flow guide groove, which is in communication with one end of the vortex groove away from the injection hole, and the opening direction of the flow guide groove is perpendicular to the vortex groove.

[0012] As a further improvement of the application, the nozzle is provided with a receiving channel, and the injection assembly further comprises a flow distribution part received in the receiving channel, one end of the flow distribution part abuts against the vortex part, and the flow guide groove, the vortex groove and the vortex cavity are arranged between the flow distribution part and the inner wall of the nozzle. The flow distribution part is arranged in the receiving channel, which on one hand reduces the space in the receiving channel, avoids a large amount of drugs from gathering in the receiving channel, and further prevents the ingredients from changing due to the long-time stay of the drugs in the receiving channel; on the other hand, the vortex cavity, the vortex groove and the flow guide groove are arranged in an open type on one side, which is convenient for processing and forming, and the flow distribution part covers and seals the vortex groove, the vortex cavity and the flow guide groove, so that the drugs can flow in the groove in the direction of the groove, and the drugs are prevented from overflowing out of the groove.

[0013] As a further improvement of the application, the vortex part comprises a structural member extending from the inner wall of the receiving channel towards the receiving channel, and a receiving cavity formed by the structural member, one end of the flow distribution part is received in the receiving cavity and tightly abuts against the cavity wall of the receiving cavity, and the structural member is fixedly connected with the nozzle, which is convenient for processing and forming of the nozzle, and can also accurately control the structural parameters of the vortex groove, the vortex cavity and the flow guide groove.

[0014] As a further improvement of the application, the flow distribution part comprises a flow distribution member and a flow convergence groove separating the flow distribution member, the distal end of the flow distribution member abuts against the structural member, the flow convergence groove is in communication with the flow guide groove in correspondence, and the outer wall surface of the flow distribution member tightly abuts against the side wall of the receiving channel. And / or, the diameter of the receiving cavity is 1.5-2.75 mm. By arranging the flow distribution member and the flow convergence groove on the flow distribution part, on one hand, the flow distribution member abuts against the inner wall of the receiving channel to fix the flow distribution part in the receiving channel, and on the other hand, the flow convergence groove is arranged to enable the drugs to flow along the flow convergence groove and then flow to the flow guide groove, and also prevents the drugs from generating vortex in the receiving channel.

[0015] As a further improvement of the application, the injection assembly further comprises a positioning part received in the receiving channel, the positioning part is provided with a positioning hole receiving the flow distribution part, the outer side wall of the positioning part is provided with flow guide strips and flow guide grooves distributed at intervals, and the flow guide strips abut against the inner wall of the receiving channel. The positioning part is arranged at one end of the receiving channel away from the injection hole and is connected with the flow distribution part, and cooperates with the vortex part to jointly limit the spatial position of the flow distribution part in the receiving channel, the flow guide strips abut against the inner wall of the receiving channel to fix the positioning part in the receiving channel, and the flow guide grooves are for the flow of the drugs.

[0016] As a further improvement of the present application, the nozzle is provided with an insertion part capable of being inserted into the nasal cavity, the length of the insertion part is 10-18mm, preferably 10-17mm, more preferably 12-17mm or 12-15mm. The insertion part is inserted into the nasal cavity, shortens the distance between the drug and the target area, and avoids the deposition of the drug on the nasal cavity wall; at the same time, the length of the insertion part is limited to avoid the distal end of the insertion part damaging the nasal mucosa of the patient and causing serious discomfort to the patient, so as to shorten the distance between the drug and the target area while taking into account the use experience of the patient.

[0017] As a further improvement of the present application, the outer diameter of the insertion part is designed to be constricted, the diameter of the proximal end of the insertion part is 4-6mm, preferably 4.5-5.5mm, and the diameter of the distal end of the insertion part is 3-5mm, preferably 3.5-4.5mm. The insertion part is designed to be constricted, which not only ensures the fit of the insertion part with the nasal cavity, but also improves the aesthetics and the use experience of the patient.

[0018] As a further improvement of the present application, the length of the insertion part is 15mm; and / or, the diameter of the proximal end of the insertion part is 5mm; and / or, the diameter of the distal end of the insertion part is 3.5mm, by further limiting the structural parameters of the insertion part, the insertion part can adapt to most patients.

[0019] As a further improvement of the present application, the nozzle further comprises a limiting part and a pressing part, one end of the limiting part is fixedly connected with the insertion part, the other end is fixedly connected with the pressing part, the pressing part, the limiting part and the insertion part are distributed in a stepped manner, in use, the insertion part is inserted into the nasal cavity of the patient to shorten the distance between the spray hole and the target area, the limiting part can abut against the nasal column and / or the alae nasi of the patient to guide or limit the length of the insertion part inserted into the nasal cavity, and the pressing part is used for the patient to hold, providing a fulcrum for the patient when pressing the device to administer the drug, and by being designed in a stepped manner, the aesthetics of the nozzle is improved.

[0020] As a further improvement of the present application, the distance between the distal end of the vortex groove away from the vortex cavity and the axis of the spray hole is 1.0mm; and / or, the diameter of the spray hole is 0.2mm; and / or, the thickness of the spray hole is 0.2mm; and / or, the thickness of the vortex groove is 0.25mm; and / or, the included angle α between the first flow guide surface and the second flow guide surface is 22°; and / or, the diameter of the vortex cavity is 1.0mm. By further limiting the structural parameters of each part in the vortex part, the drug sprayed by the spraying assembly can achieve the most suitable spray angle and spray particle size.

[0021] To achieve the above object, the application further provides a nasal spray device, comprising a medicine storage assembly and the spray assembly as described above, the medicine storage assembly comprises a medicine storage bottle and a pump body connected with the medicine storage bottle, the pump body is provided with a medicine outlet pipe extending outward, and the end of the medicine outlet pipe away from the pump body can be connected with the spray assembly to connect the spray assembly and the medicine storage assembly, so as to deliver the medicine in the medicine storage bottle to the spray assembly and then spray it outward.

[0022] As a further improvement of the application, the spray assembly comprises a flow dividing part and a positioning part, one end of the positioning part abuts against the flow dividing part, and the other end abuts against the medicine outlet pipe, so that the medicine in the medicine storage bottle flows through the medicine outlet pipe, the positioning part, the flow dividing part and the vortex part, and is finally sprayed outward through the spray hole, and the medicine outlet pipe abuts against the positioning part, so that when the patient applies pressure to shorten the distance between the spray assembly and the medicine storage assembly, the positioning part can apply pressure to the pump body through the medicine outlet pipe, so that the pump body pumps out the medicine in the medicine storage bottle and flows to the positioning part through the medicine outlet pipe.

[0023] The beneficial effects of the application are: the spray assembly of the application sets the vortex part in the spray head, so that the medicine can form a vortex and accelerate when flowing through the vortex part, thereby improving the speed of the medicine when spraying and improving the spraying distance of the medicine; the second flow guide surface is set to be tangent to the cavity wall of the vortex cavity, so that the medicine can flow smoothly into the vortex cavity, and at the same time, the medicine continuously flows to the vortex cavity to change the original flow radius of the medicine, so that the flow direction of the medicine in the vortex cavity is spiral; by limiting the included angle α between the first flow guide surface and the second flow guide surface to 14-30° and the diameter of the vortex cavity to 0.5-2.0mm, the medicine flowing through the vortex groove is pressurized and accelerated, the flow speed of the medicine is improved, and the speed of the medicine becomes a specific spiral shape, thereby forming a high-pressure spiral flow of the medicine in the vortex cavity, so that the sprayed medicine reaches the predetermined spray angle and spray particle size, avoiding the deposition of the medicine on the nasal cavity wall due to too large spray angle or too large particle size, and also avoiding the direct inhalation of the medicine into the throat or lungs due to too small particle size; further, by limiting the included angle α between the first flow guide surface and the second flow guide surface to 14-30° and the diameter of the vortex cavity to 0.5-2.0mm, and combining the length of the extension part of 10-18mm, the medicine has a better spray angle and particle size after spraying, thereby enabling the medicine to enter the superior meatus of the nose and deposit at the olfactory region of the superior meatus of the nose, improving the deposition rate of the medicine at the olfactory region of the superior meatus of the nose, and thereby meeting the requirement of high drug delivery amount. BRIEF DESCRIPTION OF DRAWINGS

[0024] Fig. 1 is a perspective view of the nasal spray device of the application.

[0025] Fig. 2 is an exploded view of the nasal spray device in Fig. 1.

[0026] Fig. 3 is a perspective view of the spray head of Fig. 2.

[0027] Fig. 4 is a sectional view of the spray head of Fig. 3.

[0028] Fig. 5 is a sectional view of the nasal spray device of Fig. 1.

[0029] Fig. 6 is a perspective view of the vortex portion and the spray hole of Fig. 4.

[0030] Fig. 7 is a front view of the vortex portion and the spray hole of Fig. 6.

[0031] Fig. 8 is a perspective view of the flow splitting portion of Fig. 2.

[0032] Fig. 9 is a perspective view of the positioning portion from a first angle of Fig. 2.

[0033] Fig. 10 is a perspective view of the positioning portion from a second angle of Fig. 2.

[0034] Fig. 11 is a schematic view of the spray effect of the nasal spray device of the present application.

[0035] Fig. 12 is a schematic view of the nasal spray device of the present application (left) and a conventional nasal spray device (right) tested in a nasal model.

[0036]

BRIEF DESCRIPTION OF THE DRAWINGS

[0037] In order to make the purpose, technical solutions and advantages of the present application clearer, the present application will be described in detail below with reference to the drawings and specific embodiments.

[0038] In the present application, "distal end" and "proximal end" are understood as relative to the distal and proximal ends of the medicine storage bottle 12 in the embodiments of the present application, "axis" is understood as the central axis of the nasal spray device 100, i.e. the central axis of the medicine outlet tube 111 in the length direction, "circumferential direction" is understood as the circumferential direction centered on the axis, and "thickness" is understood as the length in the axis direction. In the description of the orientation or positional relationship, it is only a simplified description for the convenience of description of the present application, and does not indicate or imply that the device or element referred to must have a specific orientation. "About" can be understood as indicating that the value is substantially equal, substantially equivalent, or substantially close to the value, for example, the value difference can be ±10%, preferably ±5%, more preferably ±2%.

[0039] Referring to FIGS. 1 and 2, the present application discloses a nasal spray device 100, part of which can be inserted into the nasal cavity, for spraying medicine into the nasal cavity, specifically spraying medicine into the olfactory region of the superior nasal meatus, so that the medicine can be deposited in the olfactory region of the superior nasal meatus and enter the brain through the olfactory region of the superior nasal meatus, thereby treating diseases related to the central nervous system.

[0040] The nasal spray device 100 comprises a separable or inseparable medicine storage assembly 1 and a spraying assembly 2, wherein the medicine storage assembly 1 comprises a medicine storage bottle 12 for storing medicine and a pump body 11 mounted on the bottle mouth of the medicine storage bottle 12. One end of the pump body 11 can be arranged to extend into the bottom of the medicine storage bottle 12, so as to suck the medicine in the medicine storage bottle 12 when the medicine storage bottle 12 is upright (with the bottle mouth upward); or can be arranged not to extend into the medicine storage bottle 12, so as to suck the medicine in the medicine storage bottle 12 when the medicine storage bottle 12 is inverted (with the bottle mouth downward).

[0041] In the present application, the medicine can be a gaseous medicine, a liquid aqueous medicine, a liquid oil medicine, a liquid emulsion medicine, a solid powder medicine, etc., and a pressurized gas can be filled into the medicine storage bottle 12 according to actual needs to drive the medicine to be outputted outward through the pump body 11.

[0042] In the present application, the material of the medicine storage bottle 12 can be polyethylene, polyethylene terephthalate, glass, etc., and the shape of the medicine storage bottle 12 can be designed according to actual conditions, which is not limited here, and is preferably cylindrical.

[0043] In the present application, the pump body 11 can be a conventional or unconventional pump body such as a manual press type spray pump, an electric spray pump, etc., as long as it can achieve the effect of sucking and spraying the medicine in the medicine storage bottle 12, which is not limited here.

[0044] The pump body 11 is further provided with a medicine outlet pipe 111, one end of the medicine outlet pipe 111 is connected with the output port of the pump body 11, and the other end can abut or connect with the spray assembly 2, so as to deliver the medicine in the medicine storage bottle 12 to the spray assembly 2, and then sprayed outwards through the spray assembly 2. The medicine outlet pipe 111 can also be integrally provided with the pump body 11, which is not limited here.

[0045] As shown in FIGS. 4 and 5, the spray assembly 2 includes a spray head 3, a flow dividing part 4 and a positioning part 5, the spray head 3 is provided with a receiving channel 31, the flow dividing part 4 and the positioning part 5 are received in the receiving channel 31, and a gap (not shown) for the medicine to pass through is provided between the inner wall of the receiving channel 31 and the flow dividing part 4, so that the medicine flows through the gap towards the distal end of the spray head 3 after flowing out of the medicine outlet pipe 111, and then sprayed outwards.

[0046] The size of the medicine outlet pipe 111 matches the receiving channel 31, so that the medicine outlet pipe 111 can extend into the receiving channel 31 and be tightly connected with the receiving channel 31, avoiding the medicine overflowing outwards from the connection between the medicine outlet pipe 111 and the spray head 3 during drug administration. Preferably, the medicine outlet pipe 111 is connected with the receiving channel 31 in an interference fit. Of course, in other embodiments, a sealing element can be provided between the medicine outlet pipe 111 and the receiving channel 31, or the medicine outlet pipe 111 and the spray head 3 are connected through a sealing element, so as to improve the sealing effect of the connection, avoiding the medicine flowing out from the connection between the medicine outlet pipe 111 and the receiving channel 31, which is not limited here.

[0047] Please refer to FIGS. 3 and 4, the spray head 3 includes an extending part 34, a limiting part 33 and a pressing part 32, wherein the extending part 34, the limiting part 33 and the pressing part 32 are distributed in a stepped manner, the limiting part 33 is arranged between the extending part 34 and the pressing part 32 and fixedly connected with the extending part 34 and the pressing part 32, respectively, and specifically, the extending part 34, the limiting part 33 and the pressing part 32 are designed in an integral molding manner.

[0048] The shape of the extending part 34 is similar to a circular truncated cone, and the outer diameter of the extending part 34 extends in a shrinking manner from the proximal end to the distal end, so as to be easily inserted into the nasal cavity of the patient, wherein the edge position of the distal end of the extending part 34 is preferably designed as an arc shape, avoiding the edges of the extending part 34 causing damage to the mucosa in the nasal cavity of the patient, thereby improving the comfort of the patient during drug administration. Specifically, the diameter of the proximal end of the extending part 34 is 4-6 mm, preferably 4.5-5.5 mm, and more preferably 5 mm; the diameter of the distal end of the extending part 34 is 3-5 mm, preferably 3.5-4.5 mm, and more preferably 3.5 mm. In the axial direction of the nasal spray device 100, the length of the extending part 34 is 10-18 mm, preferably 10-17 mm, more preferably 12-17 mm or 12-15 mm, and more preferably 15 mm.

[0049] The limiting portion 33 comprises a limiting platform 331 arranged at the distal end of the limiting portion 33, the limiting platform 331 is arranged around the four sides of the extending portion 34, and the diameter of at least part of the limiting portion 33 is greater than the maximum diameter of the extending portion 34. When the extending portion 34 is inserted into the nasal cavity of the patient, the limiting platform 331 abuts against the nasal column and / or the alae nasi of the patient, so as to limit the distance of the extending portion 34 inserted into the nasal cavity of the patient, so that the extending portion 34 can reach the maximum position in the nasal cavity of the patient, and the deposition rate of the drug in the olfactory region of the upper nasal cavity of the patient is improved. For patients with a shorter and smaller nasal cavity, the limiting platform 331 can guide the patient to continue to insert the extending portion 34 into the nasal cavity; for patients with a large and long nasal cavity, the limiting platform 331 can limit the patient to continue to insert the extending portion 34 into the nasal cavity.

[0050] Specifically, the limiting portion 33 is designed in a similar manner to a circular truncated cone. In the proximal end of the limiting portion 33, the limiting portion 33 extends in a contracting manner in the distal direction, and the overall diameter is greater than the maximum diameter of the extending portion 34. The connecting portion between the limiting platform 331 and the extending portion 34 and the edge of the limiting platform 331 are both arranged in an arc shape, which on the one hand improves the appearance of the nozzle 3, and on the other hand avoids damaging the nasal column and / or the alae nasi of the patient. Of course, in other embodiments, the limiting portion 33 can be arranged in a cylindrical shape, extend in an expanding manner in the proximal direction toward the distal end, etc. The limiting portion 33 can also be arranged as a circular ring, an elliptical ring, etc. in the form of a limiting platform 331, as long as the limiting platform 331 can abut against the nasal column and / or the alae nasi of the patient, limit the distance of the extending portion 34 inserted into the nasal cavity of the patient, and the shape of the limiting portion 33 is not limited herein.

[0051] The pressing portion 32 is fixedly connected to the proximal end of the limiting portion 33, and the size of the pressing portion 32 is much greater than the maximum size of the limiting portion 33. Preferably, the pressing portion 32 is arranged in a cylindrical shape.

[0052] The pressing portion 32 comprises a pressing platform 321 fixedly connected to the limiting portion 33, and the pressing platform 321 extends in the radial direction of the limiting portion 33 to form a step between the pressing portion 32 and the limiting portion 33. When the patient administers the drug, the fingers abut against the pressing platform 321 and the medicine storage bottle 12 respectively, and the pump body 11 is squeezed to pump the drug in the medicine storage bottle 12 outward.

[0053] In this embodiment, the pressing platform 321 is arranged in a ring shape, the plane where the pressing platform 321 is arranged is perpendicular to the axis of the nasal spray device 100, and an arc-shaped transition portion is arranged at the connecting portion between the pressing platform 321 and the limiting portion 33, so that the whole is beautiful, and the comfort of the patient during use is improved. Of course, in other embodiments, the plane where the pressing platform 321 is arranged can be arranged at an acute angle with the axis, or an arc-shaped recess can be arranged on the pressing platform 321 to facilitate the patient to hold with the fingers, which is not limited herein.

[0054] The pressing part 32 further comprises a connecting cavity 322 in communication with the accommodating channel 31, and the circumferential dimension of the connecting cavity 322 matches the circumferential dimension of the pump body 11 or the medicine storage bottle 12, so that the pressing part 32 can be arranged outside at least part of the pump body 11 or at least part of the medicine storage bottle 12. In this way, the pump body 11 or the medicine storage bottle 12 can move in the connecting cavity 322, thereby driving the pump body 11 to pump out the medicine liquid. Through the mutual guidance and restriction of the pump body 11 or the medicine storage bottle 12 and the inner wall of the connecting cavity 322, the damage of the nozzle 3 or the medicine outlet pipe 111 caused by uneven force can be avoided, and at the same time, the connection part of the medicine storage assembly 1 and the spraying assembly 2 is covered by the pressing part 32, which not only makes the appearance of the nasal spray device 100 beautiful, but also avoids the pollution of external pollutants to the connection part.

[0055] As shown in FIGS. 4, 6 and 7, the nozzle 3 further comprises a vortex part 35 arranged in the accommodating channel 31 and located at the distal end of the extending part 34, and the flow dividing part 4 is accommodated in the accommodating channel 31 and abuts against the vortex part 35, that is, the vortex part 35 is arranged between the inner wall of the nozzle 3 and the flow dividing part 4. The distal end of the extending part 34 is further provided with a spray hole 341, the spray hole 341 penetrates through the extending part 34 and communicates with the accommodating channel 31, the spray hole 341 is arranged on the axis of the nozzle 3 and located at the center position of the vortex part 35, so as to spray the medicine flowing through the spray hole 341 outward.

[0056] In the technical solution, the shape of the spray hole 341 is not limited (it can be regularly shaped, such as rectangular, circular, diamond, etc., and generally, in order to make the spray angle more uniform, a circular shape is preferred), and the diameter of the spray hole 341 or the diameter of the inscribed circle thereof can be 0.15-0.22 mm, preferably 0.15-0.2 mm or 0.2-0.22 mm, more preferably 0.2 mm, and the thickness of the spray hole 341 is 0.15-0.25 mm, preferably 0.15-0.2 mm or 0.2-0.22 mm, more preferably 0.2 mm.

[0057] The vortex part 35 comprises at least one structural part 351 extending from the inner wall of the accommodating channel 31 towards the inside of the accommodating channel 31. Specifically, the structural part 351 is designed in an “L” shape, that is, a part thereof extends from the side wall of the accommodating channel 31 towards the inside of the accommodating channel 31, and another part thereof extends from the end face of the accommodating channel 31 towards the inside of the accommodating channel 31, and the structural part 351 is fixedly connected with the nozzle 3, which is convenient for the processing and forming of the nozzle 3, specifically, the nozzle 3 is integrally formed, and at the same time, the structural parameters of each structure in the vortex part 35 can be accurately controlled.

[0058] In this embodiment, three structural members 351 are provided, which are uniformly distributed in the accommodation channel 31. Of course, in other embodiments, only one, two, four or more structural members 351 can be provided, which can be designed according to actual needs, and are not limited herein.

[0059] The vortex portion 35 further comprises an accommodation cavity 353. Specifically, the accommodation cavity 353 is formed by the "L"-shaped structural member 351, and the diameter of the accommodation cavity 353 is smaller than that of the accommodation channel 31. One end of the accommodation cavity 353 is in communication with the injection hole 341, and the other end is in communication with the accommodation channel 31.

[0060] As shown in FIG. 8, the shunt portion 4 comprises a shunt column 43. One end of the shunt column 43 close to the injection hole 341 is defined as an abutting end 431. The shape and size of the abutting end 431 are matched with the accommodation cavity 353, so that the abutting end 431 can be accommodated in the accommodation cavity 353, and the end face and side face of the abutting end 431 are tightly combined with the structural member 351, so as to realize the connection between the shunt portion 4 and the nozzle 3. Specifically, the diameter of the abutting end 431 is 1.5-2.75 mm, and preferably 2.0 mm. The thickness of the abutting end 431 is preferably 2.0 mm. Correspondingly, the diameter and thickness of the accommodation cavity 353 are the same as those of the abutting end 431.

[0061] The vortex portion 35 comprises a drainage groove 359, a vortex groove 354 and a vortex cavity 358. The vortex cavity 358 is in communication with the injection hole 341, and the injection hole 341 is located at the center position of the vortex cavity 358. The vortex groove 354 is in communication with the vortex cavity 358, and the vortex groove 354 is arranged in the tangential direction of the vortex cavity 358, that is, the vortex groove 354 and the vortex cavity 358 are arranged in the same plane. The drainage groove 359 is in communication with the vortex groove 354, and the opening direction of the drainage groove 359 is perpendicular to the opening direction of the vortex groove 354. Specifically, the drainage groove 359, the vortex groove 354 and the vortex cavity 358 are formed by the structural member 351, the shunt column 43 and the inner wall of the accommodation channel 31. That is, the size of the accommodation cavity 353 is related to the vortex groove 354 and the vortex cavity 358. The distance between the end of the vortex groove 354 away from the vortex cavity 358 and the axis of the injection hole 341 is 0.75-1.375 mm, and preferably 1.0 mm.

[0062] The vortex groove 354 is formed by the abutting end face 431 of the abutting end 431 of the flow distribution column 43, the inner wall of the accommodation channel 31 and the two adjacent structural members 351. Specifically, the vortex groove 354 includes a first flow guide surface 355, a second flow guide surface 356 and an annular surface 357, wherein the first flow guide surface 355 and the second flow guide surface 356 are the side wall surfaces of the two adjacent structural members 351, respectively, and the first flow guide surface 355 and the second flow guide surface 356 are oppositely arranged, the second flow guide surface 356 is smoothly connected with the annular surface 357, and the arrangement direction of the second flow guide surface 356 is the tangent direction of the annular surface 357, and the annular surface 357 is designed in an arc shape and forms a vortex cavity 358.

[0063] The vortex groove 354 is arranged in a converging manner in the direction towards the vortex cavity 358. Specifically, the included angle between the first flow guide surface 355 and the second flow guide surface 356 is a vortex angle α, and the vortex angle α is 14-30°, preferably 22°. The thickness of the vortex groove 354 is 0.1-0.25mm, preferably 0.15-0.25mm, and more preferably 0.25mm.

[0064] The vortex cavity 358 is formed by the annular surface 357 of the structural member 351, the inner wall of the accommodation channel 31 and the end face of the abutting end 431 of the flow distribution column 43, and the vortex cavity 358 is designed in a cylindrical shape, and the injection hole 341 is located at the center of the vortex cavity 358. The diameter of the vortex cavity 358 formed by the arc-shaped annular surface 357 is 0.5-2.0mm, and preferably 1.0mm.

[0065] In this embodiment, the arc-shaped annular surface 357 forms the vortex cavity 358, that is, the annular surface 357 is the cavity wall of the vortex cavity 358. Of course, in other embodiments, the end of the arc-shaped annular surface 357 away from the second flow guide surface 356 can extend into the vortex cavity 358, that is, the radius corresponding to the annular surface 357 is smaller than the radius of the vortex cavity 358, so that the medicine becomes spiral after passing through the annular surface 357 and quickly reaches the injection hole 341. As long as the medicine can pass through the annular surface 357 into the vortex cavity 358 and become spiral in the vortex cavity 358 under the guidance of the annular surface 357, the shape of the annular surface 357 is not limited here.

[0066] The drainage groove 359 is formed by the structural member 351, the inner wall of the accommodation channel 31 and the side of the abutting end 431 of the flow distribution column 43, that is, the setting direction of the drainage groove 359 is the same as the axis direction of the nozzle 3, and the setting position and size of the drainage groove 359 correspond to the vortex groove 354. In this way, the liquid medicine can flow into the vortex groove 354 from the drainage groove 359, accelerate through the contraction-shaped vortex groove 354, and then be guided to the vortex cavity 358 by the arc-shaped annular surface 357. Since the vortex groove 354 is arranged on the tangent line of the vortex cavity 358, the liquid medicine flowing out of the vortex groove 354 can flow spirally in the vortex cavity 358, and finally flow out through the spray hole 341, thereby realizing the control of the spray angle and particle size of the liquid medicine by pressurizing and accelerating the liquid medicine and making it flow spirally.

[0067] In the embodiment, the vortex groove 354 and the drainage groove 359 can each be provided with three, which are arranged between two adjacent structural members 351. The three vortex grooves 354 and the three drainage grooves 359 are respectively distributed in a rotational symmetry around the spray hole 341. The annular surface 357 can also be provided with three, which are part of the cavity wall of the vortex cavity 358. Of course, in other embodiments, the structural member 351 can also be provided with only one, that is, the three structural members 351 are connected to form a whole. At this time, the drainage groove 359 and the vortex groove 354 are provided with one, and the first guide surface 355 and the second guide surface 356 are respectively two end faces of the structural member 351, which can also realize the spiral flow of the liquid medicine in the vortex cavity 358. The number of drainage grooves 359, vortex grooves 354 and structural members 351 can also be set according to actual requirements, as long as the vortex groove 354 is arranged in the tangent direction of the vortex cavity 358, and the vortex groove 354 is designed in a contraction type, which is not limited here.

[0068] In the embodiment, the flow distribution column 43 and the vortex portion 35 are detachably connected, and the structural member 351 is integrally formed with the nozzle 3 to form the drainage groove 359, the vortex groove 354 and the vortex cavity 358 by the structural member 351, the inner wall of the accommodation channel 31 and the flow distribution column 43. In other embodiments, the flow distribution column 43, the vortex portion 35 and the nozzle 3 can be integrally formed, or the flow distribution column 43 and the vortex portion 35 can be integrally formed and tightly connected with the accommodation channel 31. The drainage groove 359, the vortex groove 354 and the vortex cavity 358 can be embedded in the structural member 351, without the need for being collectively surrounded by other structures, which is not limited here.

[0069] The shunt part 4 further comprises a shunt member 41 protruding outward from the shunt column 43, and a confluence groove 42 separating the shunt member 41. When the shunt part 4 is accommodated in the accommodation channel 31, the side of the shunt member 41 away from the shunt column 43 is closely fitted with the side wall of the accommodation channel 31 to limit the position of the shunt part 4 in the accommodation channel 31, avoiding the shunt part 4 from shaking in the accommodation channel 31. Meanwhile, the confluence groove 42 penetrates the shunt member 41 in the axial direction, so that the drug can flow along the confluence groove 42.

[0070] The end of the shunt member 41 close to the nozzle 3 is provided with a stepped surface 411, which is specifically arranged at the proximal end of the abutting end 431. The end of the structural member 351 away from the nozzle 3 is provided with an abutting table 352. When the abutting end 431 is accommodated in the accommodation cavity 353, the confluence groove 42 is communicated with the drainage groove 359, so that the drug can flow from the confluence groove 42 into the drainage groove 359. The stepped surface 411 is abutted with the abutting table 352 to avoid the drug flowing between adjacent two confluence grooves 42 or drainage grooves 359.

[0071] In the embodiment, the shunt member 41 and the confluence groove 42 are provided with three, which are uniformly distributed on the outer wall surface of the shunt column 43 to correspond to the drainage groove 359. Of course, in other embodiments, the number and arrangement position of the shunt member 41 and the confluence groove 42 can be designed according to actual conditions, as long as the shunt member 41 can abut with the structural member 351 and the confluence groove 42 is communicated with the drainage groove 359.

[0072] Please refer to FIG. 5, FIG. 9 and FIG. 10, the positioning part 5 is provided with a positioning hole 51, and the end of the shunt column 43 away from the nozzle 3 is a connecting end 432 which extends into the positioning hole 51 to realize the connection between the positioning part 5 and the shunt part 4. Specifically, the positioning hole 51 is a blind hole, and the outer wall surface of the connecting end 432 is designed in a curved surface shape, which on the one hand facilitates the positioning connection with the positioning hole 51, and on the other hand makes the drug flowing through the connecting end 432 flow uniformly.

[0073] The outer side surface of the positioning part 5 is provided with spaced apart flow guide strips 52 and flow guide grooves 53. The flow guide strips 52 and the flow guide grooves 53 are arranged along the axial direction, and the outer wall surface of the flow guide strips 52 can be closely fitted with the inner wall surface of the accommodation channel 31 to avoid the positioning part 5 from sliding out of the accommodation channel 31.

[0074] The proximal end of the positioning part 5 is provided with a recess 54 which is arranged in a cross shape or a “person” shape. The end of the recess 54 away from the axis is communicated with the flow guide groove 53. When the injection assembly 2 is connected with the drug storage assembly 1, the medicine outlet pipe 111 extends into the accommodation channel 31 and abuts with the proximal end of the positioning part 5. The medicine outlet pipe 111 flows out the drug outward, and the drug can enter the recess 54 and flow along the recess 54 to the flow guide groove 53, and then flow into the gap between the shunt column 43 and the accommodation channel 31, and further flow into the drainage groove 359.

[0075] In this embodiment, the injection assembly 2 comprises a positioning portion 5 for abutting with the medicine outlet pipe 111 and maintaining the stability of the shunt portion 4 in the accommodation channel 31. Of course, in other embodiments, the positioning portion 5 can not be provided. In this case, a groove 54 is arranged at the connecting end 432 of the shunt portion 4, and the connecting end 432 abuts with the medicine outlet pipe 111, so that the medicine outlet from the medicine outlet pipe 111 directly enters the gap. Meanwhile, a sealing member can be arranged between the medicine outlet pipe 111 and the accommodation channel 31 to achieve the sealed connection of the medicine outlet pipe 111 and the accommodation channel 31, which is not limited herein.

[0076] Experimental section:

[0077] In one aspect of the present application, the inventors tested the existing nasal spray devices on the market and found that the spray angles of the existing nasal spray devices were basically above 50°, and the spray particle size D90 distribution was poor, resulting in that most of the drugs could not effectively reach the target area after being sprayed. After modeling and researching the human nasal cavity, the inventors further found that when the spray angle is greater than 40° or the particle size of the drug is large (for example, D90 is greater than 130 μm), most of the drugs are likely to directly contact the nasal cavity wall or directly adsorb and adhere to the nasal cavity wall after being sprayed, resulting in that they cannot effectively reach the target area; and when the spray angle is less than 40° or the particle size of the drug is too small (for example, less than 80 μm), most of the drugs are likely to enter the throat or lungs along with the patient's breathing.

[0078] According to the research on the patient's nasal cavity and long-term research, the inventors' team preliminarily determined that when the spray angle of the nasal spray device 100 is between 15-40° and the spray particle size D90 is between 80-130 μm, most of the drugs sprayed by the nasal spray device 100 will not directly contact and adsorb the nasal cavity wall, nor will they be directly inhaled into the throat and lungs by the patient, but will enter the target area (for example, the olfactory region of the nasal cavity) along the nasal cavity channel; specifically, when the spray angle is about 25° and the spray particle size D90 is about 100 μm, the spray has a better shape and a larger amount of drugs can enter the nasal cavity through the nasal cavity.

[0079] To this end, the inventors' team improved and tested the existing nasal spray devices in order to obtain a nasal spray device 100 with a spray angle β between 15-40° and a spray particle size D90 between 80-130 μm. The drug used in the experimental process is a solution with a liquid viscosity between 0.96-1.1 Pa·s. After the drug is sprayed from the spray hole 341, a conical mist zone is formed, and the spray angle β is the angle of the cone at the spray hole 341. Please refer to FIG. 11.

[0080] Spray angle test method:

[0081] Instrument name: Malvern Mastersizer 2000

[0082] Model: Imaging Division

[0083] Turn on the equipment, place the device on the test platform as required, and determine the horizontal and vertical positions. Determine the position of the laser emitter.

[0084] Turn on the instrument and check the calibration mark to confirm that the instrument is within the calibration period.

[0085] Turn on the trigger software, set the trigger parameters, and click START. By collecting spray images, using image algorithms for image recognition, and calculating spray angles through binary images, the spray field image is extracted through image gray scale transformation, threshold segmentation, morphological denoising, and edge detection. The straight line fitting method is used to calculate the fog field boundary and atomization angle, realizing the digital measurement of the nozzle atomization angle. Record the spray angle data and save the data.

[0086] Test method of spray particle size:

[0087] Instrument name: Spray particle size tester

[0088] Model: Spraytecnss STP2000

[0089] Remove the equipment cover. Insert the nozzle of the device into the circular tray and place it in the upper slot of the trigger. Turn on the instrument and check the calibration mark to confirm that the instrument is within the calibration period. Turn on the power of the spray particle size tester, the Proveris trigger, and the computer, and preheat for not less than 30 minutes to stabilize the energy of the laser.

[0090] Start the trigger software and set the trigger parameters. Click START to start measurement. The laser particle size instrument emits a laser beam through the spray area, and calculates the particle size distribution of the droplets by measuring the intensity distribution of scattered light. The computer records and analyzes the data to obtain the median particle size D50 and D90 values at a distance of 3 cm from the nozzle.

[0091] Example 1

[0092] According to the research of the influence of various parameters in the nasal spray device 100 on the spray angle β and the spray particle size D90 by the inventor team, it is found that the diameter of the vortex cavity 358 and the vortex angle α have a greater influence on the spray angle β and the spray particle size D90 of the device. Therefore, in the present embodiment, the influence of the diameter of the vortex cavity 358 and the vortex angle α on the spray angle β and the spray particle size D90 of the device is tested, wherein the other structural parameters of the nasal spray device 100 can be set according to the actual situation or referring to the existing device, for example: the diameter of the accommodation cavity 353 is 2.0 mm, the diameter of the spray hole 341 is 0.25 mm, the thickness of the spray hole 341 is 0.25 mm, the thickness of the vortex groove 354 is 0.25 mm, etc.

[0093] The experimental data are as follows:

[0094] It can be seen from the above experimental data that the parameters of the diameter of the vortex cavity 358 and the vortex angle α indeed have a great influence on the spray angle β and the spray particle size D90, wherein when the diameter of the vortex cavity 358 is 0.5-2.0 mm and the vortex angle α is 14-30°, the target requirements of the spray angle β being between 15-40° and the spray particle size D90 being between 80-130 μm can be met at the same time; wherein when the diameter of the vortex cavity 358 is about 1.0 mm and the vortex angle α is about 22°, a more optimal spray angle and spray particle size (the spray angle β is about 25° and the spray particle size D90 is about 100 μm) can be achieved.

[0095] Embodiment 2

[0096] In the present embodiment, the influence of the diameter of the accommodation cavity 353 on the spray angle β and the spray particle size D90 of the device is researched, the diameter of the accommodation cavity 353 is set to be 1.50 mm, 1.75 mm, 2.00 mm, 2.25 mm, 2.50 mm, 2.75 mm respectively, the diameter of the vortex cavity 358 is set to be 1.0 mm, the vortex angle α is set to be 22°, and the other structural parameters of the nasal spray device 100 can be set according to the actual situation or referring to the device of Embodiment 1.

[0097] According to the experimental test of the inventor team, when the diameter of the accommodation cavity 353 is about 1.5-2.75 mm, the spray angle β of the nasal spray device 100 can reach 15-40°, and the target requirements of the spray particle size D90 being between 80-130 μm can be met. When the diameter of the accommodation cavity 353 is about 2.00 mm, the spray angle β of the device is more likely to reach 25°, and the spray particle size D90 is more likely to reach the more optimal value of 100 μm.

[0098] It should be noted that the distance between the end of the vortex groove 354 away from the vortex chamber 358 and the axis of the nozzle hole 341 is the radius of the accommodation chamber 353, so the distance between the end of the vortex groove 354 away from the vortex chamber 358 and the axis of the nozzle hole 341 can be about 0.75-1.375mm, preferably about 1.0mm.

[0099] Example 3

[0100] In this embodiment, the inventors' team studied the influence of the diameter of the nozzle hole 341 on the spray angle β and the spray particle size D90 of the device, and the diameter of the nozzle hole 341 was set to 0.15mm, 0.20mm and 0.22mm respectively, the diameter of the vortex chamber 358 was set to 1.0mm, the vortex angle α was set to 22°, and the other structure parameters of the nasal spray device 100 can be set according to the device of Example 1 or according to the actual situation.

[0101] Through the experimental test of the inventors' team, when the diameter of the nozzle hole 341 is about 0.15-0.22mm, the spray angle β of the nasal spray device 100 can reach 15-40°, and the target requirement that the spray particle size D90 is between 80-130μm. When the diameter of the nozzle hole 341 is about 0.2mm, the spray angle β of the device is more likely to reach 25°, and the spray particle size D90 is more likely to reach the more optimal value of 100μm.

[0102] Example 4

[0103] In this embodiment, the inventors' team studied the influence of the thickness of the nozzle hole 341 on the spray angle β and the spray particle size D90 of the device, and the thickness of the nozzle hole 341 was set to 0.15mm, 0.20mm and 0.22mm respectively, the diameter of the vortex chamber 358 was set to 1.0mm, the vortex angle α was set to 22°, and the other structure parameters of the nasal spray device 100 can be set according to the device of Example 1 or according to the actual situation.

[0104] Through the experimental test of the inventors' team, when the thickness of the nozzle hole 341 is about 0.15-0.25mm, the spray angle β of the nasal spray device 100 can reach 15-40°, and the target requirement that the spray particle size D90 is between 80-130μm. When the thickness of the nozzle hole 341 is about 0.2mm, the spray angle β of the device is more likely to reach 25°, and the spray particle size D90 is more likely to reach the more optimal value of 100μm.

[0105] Example 5

[0106] In this embodiment, the inventor team studied the effect of the thickness of the vortex groove 354 on the spray angle β and the spray particle size D90 of the device. The thickness of the vortex groove 354 was set to 0.10 mm, 0.15 mm, 0.20 mm, and 0.25 mm, respectively. The diameter of the vortex chamber 358 was set to 1.0 mm, and the vortex angle α was set to 22°. The other structural parameters of the nasal spray device 100 can be set according to the device of Embodiment 1 or according to the actual situation.

[0107] Through experimental testing by the inventor team, when the thickness of the vortex groove 354 is between about 0.1-0.25 mm, the spray angle β of the nasal spray device 100 can reach between 15-40°, and the spray particle size D90 meets the target requirement of between 80-130 μm. When the thickness of the vortex groove 354 is about 0.25 mm, the spray angle β of the device is more likely to reach 25°, and the spray particle size D90 is more likely to reach the more optimal value of 100 μm.

[0108] Embodiment 6

[0109] The thickness of the vortex groove 354 in the vortex portion 35 was set to 0.25±0.005 mm, the diameter of the receiving cavity 353 was set to 2.0±0.04 mm, the diameter of the spray hole 341 was set to 0.20±0.004 mm, the thickness of the spray hole 341 was set to 0.20±0.004 mm, the diameter of the vortex chamber 358 was set to 1.0±0.02 mm, and the vortex angle α was set to 22°±0.5°. The other structural parameters of the nasal spray device 100 were set according to the existing device.

[0110] Through experimental testing, the spray angle in the results was 25.4°, and the spray particle size D90 was 100 μm.

[0111] In another aspect of the present application, according to the research on drug delivery to the brain through the nose in the prior art, the drug needs to be delivered and effectively deposited in the olfactory region of the upper nasal meatus to achieve the effect of drug delivery to the brain through the nose. According to the research on the nasal cavity of patients and the long-term research and development experience of the inventor team, it is preliminarily determined that the deposition rate in the olfactory region of the upper nasal meatus should at least reach 20% to preliminarily meet the requirement of high drug delivery amount, and at the same time, the waste of drugs not deposited in the olfactory region of the upper nasal meatus can be reduced. Of course, the higher the deposition rate in the olfactory region of the upper nasal meatus, the higher the effective drug delivery amount, and the better the drug efficacy.

[0112] In this regard, the inventor team tested an existing nasal spray device to test the deposition rate of the drug sprayed by the existing nasal spray device in the olfactory region of the upper nasal meatus. After multiple tests, the highest deposition rate of the drug in the olfactory region of the upper nasal meatus was only about 10%, which was difficult to meet the requirement of high drug delivery amount.

[0113] Therefore, the present inventors preliminarily determined the insertion length and the nasal cavity passage size suitable for most human nasal cavities by studying the shape and size of the nasal septum protruding part of different human nasal cavities, and then improved the nasal spray device 100 to improve the drug deposition rate in the olfactory region of the superior nasal meatus.

[0114] Meanwhile, the inventors' team tested the improved nasal spray device 100, and the drug used in the experiment was a solution with a liquid viscosity of 0.96-1.1 Pa·s. After the drug was sprayed from the spray hole 341, a conical mist area was formed, and the test method and instrument for the deposition rate in the olfactory region of the superior nasal meatus can refer to the existing test method and instrument.

[0115] Example 7

[0116] Through the research of the inventors' team on the influence of various parameters of the nasal spray device 100 on the deposition rate in the olfactory region of the superior nasal meatus, it was found that the diameter of the vortex chamber 358 and the vortex angle α have a greater influence on the deposition rate of the sprayed drug in the olfactory region of the superior nasal meatus. Therefore, in this embodiment, the influence of the diameter of the vortex chamber 358 and the vortex angle α on the deposition rate of the sprayed drug in the olfactory region of the superior nasal meatus was tested, wherein the other structural parameters of the nasal spray device 100 can be set according to the actual situation or with reference to the existing device, for example: the diameter of the accommodation chamber 353 is 2.0 mm, the diameter of the spray hole 341 is 0.25 mm, the thickness of the spray hole 341 is 0.25 mm, the thickness of the vortex groove 354 is 0.25 mm, and the length of the insertion part 34 can be set according to the conventional setting, for example, 6-25 mm (15 mm in this embodiment).

[0117] The experimental data are as follows:

[0118] According to the experiment, it can be seen that when the diameter of the vortex chamber 358 is between 0.5-2.0 mm and the vortex angle α is between 14°-30°, the deposition rate in the olfactory region of the superior nasal meatus is greater than 20%, which can meet the requirement of high drug delivery amount, and when the diameter of the vortex chamber 358 is about 1.0 mm and the vortex angle α is about 25°, the deposition rate reaches a relatively high point.

[0119] Example 8

[0120] In this embodiment, the diameter of the vortex chamber 358 in the vortex portion 35 is set to 1.0±0.1 mm and the vortex angle a is set to 25°±1°, and other structural parameters of the nasal spray device 100 can be set according to actual conditions or by referring to existing devices (for example, the thickness of the vortex groove 354 is set to about 0.25 mm, the diameter of the accommodation cavity 353 is set to about 2.0 mm, the diameter of the spray hole 341 is set to about 0.20 mm, the thickness of the spray hole 341 is set to about 0.20 mm, and the length of the extending portion 34 is about 15 mm, etc.), and the existing device with a vortex structure and an extending portion with a length of 15 mm is tested for comparison.

[0121] The nasal cavity model was used to test the distribution of the drug in the nasal cavity model, respectively; please refer to FIG. 12, it can be clearly seen that the drug sprayed by the nasal spray device 100 of the present application is more distributed in the upper nasal meatus olfactory region; the drug sprayed by the existing device is less distributed in the upper nasal meatus olfactory region.

[0122] The nasal cavity model was used to test the distribution of the drug in the nasal cavity model, respectively; please refer to FIG. 12, it can be clearly seen that the drug sprayed by the nasal spray device 100 of the present application is more distributed in the upper nasal meatus olfactory region; the drug sprayed by the existing device is less distributed in the upper nasal meatus olfactory region.

[0123] According to the patient deposition rate results, using the existing device, the deposition rate of the drug in the upper nasal meatus olfactory region is only 5% to 9%. Using the nasal spray device 100 of the present application, the deposition rate of the drug in the upper nasal meatus olfactory region of 8 different patients is 48% to 55%, which is about 6 to 9 times that of the prior art.

[0124] Embodiment 9

[0125] In this embodiment, the effect of the length of the extending portion 34 on the deposition rate in the upper nasal meatus olfactory region is tested, and the structural parameters in the vortex portion 35 are set according to Embodiment 12, and other structural parameters of the nasal spray device 100 can be set according to actual conditions.

[0126] The experimental data are as follows:

[0127] From the above experimental data, it can be seen that when the length of the extending portion 34 is between 10-17 mm, the deposition rate of the drug in the upper nasal meatus olfactory region is more than 20%, and when the length of the extending portion 34 is 15 mm, the deposition rate in the upper nasal meatus olfactory region is relatively the highest.

[0128] In the experiment, when the length of the insertion part 34 exceeds 17 mm, it will abut against the mucosa of the nasal septum in the nasal cavity, causing a stinging sensation of the nasal mucosa, causing the patient to feel severe discomfort, and even causing damage to the patient's mucosa. Of course, in some special groups of people with curved nasal septums, wide nasal vestibules, or small nasal septum protrusions, the length of the insertion part 34 can also reach 18 mm or more, and the deposition rate of the drug in the olfactory region of the superior nasal meatus is still not less than 20%.

[0129] In summary, the spray assembly 2 of the present application sets the vortex part 35 in the spray head 3, so that the drug forms a vortex and accelerates when flowing through the vortex part 35; by limiting the structural parameters of the vortex part 35, the sprayed drug reaches the predetermined spray angle β and spray particle size, improving the deposition rate of the drug in the olfactory region of the superior nasal meatus, and thus meeting the requirement of high drug delivery amount; by further limiting the length of the insertion part 34, the insertion part 34 can extend into the patient's nasal cavity as much as possible without damaging the nasal mucosa, further assisting to improve the deposition rate in the olfactory region of the superior nasal meatus; by setting the limiting table 331 on the spray head 3, which can abut against the patient's alae nasi, further guiding or limiting the length of the insertion part 34 inserted into the nasal cavity.

[0130] The above embodiments are only used to illustrate the technical solutions of the present application and are not limiting. Although the present application has been described in detail with reference to the preferred embodiments, it should be understood by those skilled in the art that the technical solutions of the present application can be modified or replaced equivalently without departing from the spirit and scope of the technical solutions of the present application.

Claims

1. A spray assembly characterized by: The nozzle (3) has a spray hole (341) at its distal end, and the vortex portion (35) includes a vortex cavity (358) in communication with the spray hole (341), and a vortex groove (354) in communication with the vortex cavity (358), the vortex groove (354) includes oppositely arranged first and second flow guide surfaces (355, 356), the second flow guide surface (356) is tangent to the cavity wall of the vortex cavity (358), the included angle (α) between the first flow guide surface (355) and the second flow guide surface (356) is 14-30°, and the diameter of the vortex cavity (358) is 0.5-2.0 mm.

2. The spray assembly of claim 1, wherein: The distance between the end of the vortex groove (354) away from the vortex cavity (358) and the axis of the spray hole (341) is 0.75-1.375 mm; And / or, the diameter of the spray hole (341) is 0.15-0.22 mm; And / or, the thickness of the spray hole (341) is 0.15-0.25 mm; And / or, the thickness of the vortex groove (354) is 0.1-0.25 mm; And / or, the vortex groove (354) is arranged in a converging manner in the direction towards the vortex cavity (358).

3. The spray assembly of claim 1 or 2, wherein: The vortex groove (354) further includes an arc-shaped annular surface (357) smoothly connected with the second flow guide surface (356), the annular surface (357) surrounds the vortex cavity (358) or the end of the annular surface (357) away from the second flow guide surface (356) extends into the vortex cavity (358), the vortex cavity (358) is arranged in the same plane with the vortex groove (354), and the vortex groove (354) is provided with at least one.

4. The jet assembly of any one of claims 1 to 3, wherein: The vortex portion (35) further includes a flow guide groove (359) in communication with the end of the vortex groove (354) away from the spray hole (341), and the opening direction of the flow guide groove (359) is perpendicular to the vortex groove (354).

5. The spray assembly of claim 4, wherein: The nozzle (3) is provided with a receiving channel (31), and the spray assembly (2) further includes a flow distribution portion (4) received in the receiving channel (31), one end of the flow distribution portion (4) abuts against the vortex portion (35), and the flow guide groove (359), the vortex groove (354) and the vortex cavity (358) are arranged between the flow distribution portion (4) and the inner wall of the nozzle (3).

6. The spray assembly of claim 5, wherein: The vortex portion (35) includes a structural member (351) extending from the inner wall of the receiving channel (31) towards the receiving channel (31), and a receiving cavity (353) surrounded by the structural member (351), one end of the flow distribution portion (4) is received in the receiving cavity (353) and tightly abuts against the cavity wall of the receiving cavity (353).

7. The spray assembly of claim 6, wherein: The shunt part (4) comprises a shunt member (41) and a confluence groove (42) separating the shunt member (41), the distal end of the shunt member (41) abuts against the structural member (351), and the confluence groove (42) communicates with the drainage groove (359) correspondingly, the outer wall surface of the shunt member (41) is tightly fitted with the side wall of the accommodation channel (31); And / or, the diameter of the accommodation cavity (353) is 1.5-2.75 mm.

8. The spray assembly of any one of claims 5 to 7, wherein: The injection assembly (2) further comprises a positioning part (5) accommodated in the accommodation channel (31), the positioning part (5) is provided with a positioning hole (51) accommodating the shunt part (4), and the outer side wall of the positioning part (5) is provided with spaced distribution of flow guide strips (52) and flow guide grooves (53), and the flow guide strips (52) abut against the inner wall of the accommodation channel (31).

9. The jet assembly of any one of claims 1 to 8, wherein: The nozzle (3) is provided with an insertion part (34) capable of being inserted into the nasal cavity, and the length of the insertion part (34) is 10-18 mm.

10. The spray assembly of claim 9, wherein: The outer diameter of the insertion part (34) is designed in a tapered manner, the proximal end diameter of the insertion part (34) is 4-6 mm, and the distal end diameter of the insertion part (34) is 3-5 mm.

11. The spray assembly of claim 9 or 10, wherein: The length of the insertion part (34) is 15 mm; And / or, the proximal end diameter of the insertion part (34) is 5 mm; And / or, the distal end diameter of the insertion part (34) is 3.5 mm.

12. The jet assembly of any one of claims 9 to 11, wherein: The nozzle (3) further comprises a limiting part (33) and a pressing part (32), one end of the limiting part (33) is fixedly connected with the insertion part (34), the other end is fixedly connected with the pressing part (32), and the pressing part (32), the limiting part (33) and the insertion part (34) are distributed in a stepped manner.

13. The jet assembly of any one of claims 1 to 12, wherein: The distance between the distal end of the vortex groove (354) away from the vortex cavity (358) and the axis of the injection hole (341) is 1.0 mm; And / or, the diameter of the injection hole (341) is 0.2 mm; And / or, the thickness of the injection hole (341) is 0.2 mm; And / or, the thickness of the vortex groove (354) is 0.25 mm; And / or, the included angle (α) between the first flow guide surface (355) and the second flow guide surface (356) is 22°; And / or, the diameter of the vortex cavity (358) is 1.0 mm.

14. A nasal spray device characterized by: The injection assembly (2) further comprises a positioning part (5) accommodated in the accommodation channel (31), the positioning part (5) is provided with a positioning hole (51) accommodating the shunt part (4), and the outer side wall of the positioning part (5) is provided with spaced distribution of flow guide strips (52) and flow guide grooves (53), and the flow guide strips (52) abut against the inner wall of the accommodation channel (31). The nozzle (3) is provided with an insertion part (34) capable of being inserted into the nasal cavity, and the length of the insertion part (34) is 10-18 mm. The outer diameter of the insertion part (34) is designed in a tapered manner, the proximal end diameter of the insertion part (34) is 4-6 mm, and the distal end diameter of the insertion part (34) is 3-5 mm. The length of the insertion part (34) is 15 mm; And / or, the proximal end diameter of the insertion part (34) is 5 mm; And / or, the distal end diameter of the insertion part (34) is 3.5 mm. The nozzle (3) further comprises a limiting part (33) and a pressing part (32), one end of the limiting part (33) is fixedly connected with the insertion part (34), the other end is fixedly connected with the pressing part (32), and the pressing part (32), the limiting part (33) and the insertion part (34) are distributed in a stepped manner. The distance between the distal end of the vortex groove (354) away from the vortex cavity (358) and the axis of the injection hole (341) is 1.0 mm; And / or, the diameter of the injection hole (341) is 0.2 mm; And / or, the thickness of the injection hole (341) is 0.2 mm; And / or, the thickness of the vortex groove (354) is 0.25 mm; And / or, the included angle (α) between the first flow guide surface (355) and the second flow guide surface (356) is 22°; And / or, the diameter of the vortex cavity (358) is 1.0 mm. The injection assembly (2) further comprises a positioning part (5) accommodated in the accommodation channel (31), the positioning part (5) is provided with a positioning hole (51) accommodating the shunt part (4), and the outer side wall of the positioning part (5) is provided with spaced distribution of flow guide strips (52) and flow guide grooves (53), and the flow guide strips (52) abut against the inner wall of the accommodation channel (31). The nozzle (3) is provided with an insertion part (34) capable of being inserted into the nasal cavity, and the length of the insertion part (34) is 10-18 mm.

15. The nasal spray device of claim 14, wherein: The injection assembly (2) comprises a flow distribution part (4) and a positioning part (5), one end of the positioning part (5) abuts against the flow distribution part (4), and the other end abuts against the medicine outlet pipe (111), so that the medicine in the medicine storage bottle (12) is sprayed outwards through the medicine outlet pipe (111), the positioning part (5), the flow distribution part (4), the vortex part (35) and the injection hole (341) finally.

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