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 provided with an accommodating channel and a flow-dividing portion accommodated in the channel. The flow-dividing portion comprises flow-dividing members that are spaced apart and a converging groove arranged between two adjacent flow-dividing members. The flow-dividing members can abut against a side wall of the accommodating channel to connect the flow-dividing portion and the spray head. The converging groove extends in a direction from the near end of the flow-dividing portion to the far end of the flow-dividing portion, and the circumferential size of the near end is greater than the circumferential size of the far end. In the spray assembly of the present application, arranging the flow-dividing members enables the drug in the accommodating channel to be divided, configuring the converging groove such that the size of the near end is greater than the size of the far end enables the drug in the groove to be pressurized and subjected to pressure equalization, and arranging the flow-dividing members and configuring the converging groove such that the size of the near end is greater than the size of the far end enables the central axis of the spray is substantially consistent with the axis of the spray assembly, so that the spray direction of the drug is prevented from being deviated, and the error in the drug amount sprayed each time is relatively small, which ensures that the drug amount administered is accurate and consistent.

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, the brain-cerebrospinal fluid barrier and the 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 given by directly injecting 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 drug 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 very 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 non-invasive brain efficient 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] Based on the physiological structure of the anterior nasal vestibule of the human nasal cavity, there is a nasal septum protrusion structure between the nasal valve and the superior nasal meatus, which causes the channel to be very narrow at this point, and the shape and size of the channel of different patients differ greatly, hindering the enrichment of drugs to the superior nasal meatus. Aptar, the current mainstream nasal cavity delivery device supplier, claims to have a nasal cavity delivery device that can achieve a superior nasal meatus delivery efficiency of more than 50%, but in actual use, the spray direction of the drug will deviate obviously (the deviation angle δ is about 57.9°), as shown in FIG. 1, which causes the spray to be directly sprayed on the inner wall of the nasal cavity, resulting in a very low drug delivery efficiency; at the same time, the amount of drug sprayed each time varies greatly, making it difficult to ensure the accuracy and consistency of the drug administration amount, and this instability seriously affects the therapeutic effect of the drug.

[0005] The prior art also proposes a technical solution of arranging a filling rod with a groove in the spray head, which improves the pressure of the drug in the spray head by arranging the filling rod in a continuous or gradually reduced manner, for example, the Chinese patent with application number CN 202080062099.1, in which the filling rod pressurizes the drug in a gradually reduced manner, so that the drug can have a faster ejection speed, but does not solve the problems of spray angle deviation and difficult determination of drug application amount.

[0006] The Chinese patent with application number CN 202320634030.2 proposes to arrange a water core in the spray head, and the rear end of the water core is circumferentially arranged with a water passing groove for the drug liquid to pass through, and the front end of the water core is not arranged with a water passing groove. The purpose of the water core in this application is to abut against the water outlet pipe, so that the drug liquid in the water outlet pipe flows into the water passing groove, and it does not mention that it can solve the problem of spray angle deviation. At the same time, this application is to determine the amount of drug by the plunger assembly, and does not solve the problem of different drug application amount for each spray.

[0007] Therefore, it is necessary to improve the existing nasal spray device to solve the above problems. SUMMARY

[0008] The purpose of the present application is to provide a spray assembly and a nasal spray device to solve at least one of the problems of the spray direction of the existing nasal spray device deviating greatly and the drug amount for each spray being greatly different.

[0009] To achieve the above-mentioned purpose, the present application provides a spray assembly, which comprises a spray head provided with a receiving channel and a flow dividing part received in the receiving channel, the flow dividing part is provided with a flow dividing piece and a flow collecting groove, the flow dividing piece and the flow collecting groove both extend from the proximal end of the flow dividing part to the distal end direction, at least part of the flow dividing piece can abut against the channel wall of the receiving channel to connect the flow dividing part and the spray head; the circumferential size of the proximal end of the flow collecting groove is greater than the circumferential size of the distal end of the flow collecting groove, the spray head comprises a spray hole capable of communicating with the flow collecting groove, the drug flows through the flow collecting groove and collects at the spray hole before being sprayed outward. By arranging the flow dividing piece on the flow dividing part, the turbulent flow and bubbles of the drug in the receiving channel are avoided or reduced; by arranging the flow collecting groove with the proximal end size greater than the distal end size, the drug in the flow collecting groove is pressurized and equalized, which further makes the deviation angle of the sprayed drug spray meet the demand (for example, greater than 85°, preferably close to 90°), and at the same time, the spray weight of each time is within the range of standard spray weight ± 5% (preferably, the single spray weight is within the range of standard spray weight ± 2% or so), which improves the stability and consistency of the drug application amount.

[0010] As a further improvement of the present application, in the circumferential direction of the flow distribution part, the groove bottom of the flow converging groove can be linear or arcuate or substantially linear or substantially arcuate, preferably linear or arcuate, more preferably arcuate, most preferably arcuate with the flow distribution part axis as the center.

[0011] As a further improvement of the present application, in the direction from the proximal end to the distal end of the flow distribution part, the circumferential dimension of the flow converging groove is arranged in a converging manner, preferably in a uniform converging manner, more preferably in a linear uniform converging manner (for example, the opposite two side walls of the flow converging groove are linearly arranged, and the opposite two side walls are non-parallel).

[0012] As a further improvement of the present application, the flow converging groove comprises a flow distribution segment and a flow out segment, the maximum flow distribution angle γ corresponding to the flow distribution segment is 60-95°, preferably 70-90°, more preferably 80-90°, most preferably 90°; the minimum flow out angle θ corresponding to the flow out segment is 25-35°, preferably 25-30° or 30-35°, more preferably 30°. The flow distribution angle γ is the central angle corresponding to the flow distribution segment, and the flow out angle θ is the central angle corresponding to the flow out segment.

[0013] As a further improvement of the present application, in the direction from the proximal end to the distal end of the flow distribution part, the flow distribution part comprises a flow distribution segment, a flow converging segment and a flow out segment which can be communicated, in the circumferential direction of the flow distribution part, the opposite two side walls of the flow distribution segment are arranged in parallel or converging manner, the opposite two side walls of the flow out segment are arranged in parallel or converging manner, the flow converging segment is arranged in arcuate converging manner, and one end of the flow converging segment is connected to the flow distribution segment and the other end is connected to the flow out segment, preferably, the opposite two side walls of the flow distribution segment are arranged in parallel, the opposite two side walls of the flow out segment are arranged in parallel, and the central angle corresponding to the flow distribution segment is greater than the central angle corresponding to the flow out segment.

[0014] As a further improvement of the present application, the maximum flow distribution angle γ corresponding to the flow distribution segment is 60-95°, preferably 70-90°, more preferably 80-90°, most preferably 90°; the minimum flow out angle θ corresponding to the flow out segment is 25-35°, preferably 25-30° or 30-35°, more preferably 30°; the diameter of the flow converging segment is 1.5-2.5mm, preferably 2.0-2.3mm, more preferably 2.0mm.

[0015] As a further improvement of the present application, the thickness of the flow converging groove is 0.2-0.35mm, preferably 0.25-0.3mm, more preferably 0.3mm;

[0016] And / or, the length of the flow distribution segment is 7.5-11.5mm, preferably 7.5-9.0mm or 9.0-11.5mm, more preferably 9.5mm;

[0017] And / or, the length of the outflow section is 1.65-2.05 mm, preferably 1.65-1.85 mm or 1.85-2.05 mm, more preferably 1.85 mm;

[0018] And / or, the distal end of the shunt section is provided with an abutment end, and the length of the abutment end is 2.0-3.5 mm, preferably 2.5-3.0 mm, more preferably 2.5 mm.

[0019] As a further improvement of the present application, the proximal end of the shunt member can also be provided with a shunt end, which is arc-shaped or tapered or trapezoidal, preferably arc-shaped, and more preferably protruding in the direction of the proximal end, so as to stabilize and evenly guide the flow of the drug solution, avoid local turbulence of the drug, and reduce the air bubbles that may be generated in the drug, further improve the stability of the amount of drug per administration, and reduce the difference between the amounts of drug per administration (for example, the difference between the amounts of drug per administration is less than 5% of the average value or the relative standard deviation between the amounts of drug per administration can be less than 5%).

[0020] As a further improvement of the present application, the nozzle further comprises a vortex portion arranged in the accommodation channel, and the vortex portion comprises an accommodation cavity, a structural member, and a vortex channel, wherein the structural member is annularly arranged in the circumferential range of the accommodation channel and is fixedly connected with the channel wall of the accommodation channel, the accommodation cavity is formed by the structural member (i.e. the structural member is arranged between the accommodation cavity and the channel wall of the accommodation channel), and the vortex channel is embedded in the structural member.

[0021] As a further improvement of the present application, the shunt portion can be connected with the vortex portion, at this time, the abutment end is accommodated in the accommodation cavity and abuts against the cavity wall of the accommodation cavity, preferably, the outer side wall of the abutment end is tightly connected with the structural member, and more preferably, the circumferential outer side wall and the end face of the abutment end can be tightly connected with the structural member.

[0022] As a further improvement of the present application, the proximal end of the structural member is provided with an abutment platform, the distal end of the shunt member is provided with a stepped surface, when the abutment end is accommodated in the accommodation cavity, the abutment platform abuts against the stepped surface, and the flow collection groove communicates with the vortex channel, so that the drug can enter the vortex channel through the flow collection groove, and preferably, the abutment platform and the stepped surface are tightly connected. In this way, any two flow collection grooves cannot be communicated, avoiding the mixing of drugs in different flow collection grooves.

[0023] As a further improvement of the present application, one end of the vortex channel can communicate with a plurality of flow collection grooves respectively, and the other end can communicate with the spray hole, so that the drugs in the plurality of flow collection grooves are mixed in the vortex channel and sprayed outward through the spray hole. By connecting the vortex channel with a plurality of flow collection grooves and collecting the drugs in the plurality of flow collection grooves and then spraying them outward, the vortex channel can accelerate and spiral the drugs, so as to control the drugs in the flow collection groove and the vortex channel and change the shape of the drugs when sprayed.

[0024] As a further improvement of the present application, the vortex channel comprises a vortex cavity in communication with the injection hole, and a vortex groove in communication with the vortex cavity, the vortex groove comprises oppositely arranged first and second flow guide surfaces, the second flow guide surface is tangent to the cavity wall of the vortex cavity, the included angle α between the first flow guide surface and the second flow guide surface is 14-30°, and the diameter of the vortex cavity is 0.5-2.0 mm. By setting the included angle α to be 14-30° and the diameter of the vortex cavity to be 0.5-2.0 mm, the drug can have a better spray angle and particle size after being sprayed, so that the drug can enter the superior nasal meatus and deposit at the olfactory region of the superior nasal meatus, thereby improving the deposition rate of the drug at the olfactory region of the superior nasal meatus, solving the problem of low deposition rate of the drug sprayed by the existing nasal spray device at the olfactory region of the superior nasal meatus, and thereby achieving the requirement of high drug delivery amount.

[0025] The shunt part comprises a shunt column, and the shunt member protrudes outward from the shunt column. Further, the shunt column is detachably connected with the vortex part; or the shunt column, the vortex part and the nozzle are integrally formed; or the shunt column and the vortex part are integrally formed.

[0026] To achieve the above-mentioned purpose, the present application also provides a nasal spray device, which comprises a drug storage assembly and the aforementioned spray assembly. The drug storage assembly comprises a drug storage bottle and a pump body connected with the drug storage bottle. The pump body is provided with an outwardly extending drug outlet pipe. The end of the drug outlet pipe away from the pump body can be connected with the spray assembly to deliver the drug in the drug storage bottle to the spray assembly and then spray it outward.

[0027] As a further improvement of the present application, the spray assembly further comprises a positioning part accommodated in the accommodation channel. The positioning part is provided with a positioning hole. The connecting end of the shunt part extends into the positioning hole. The outer side of the positioning part is provided with spaced apart flow guide strips and flow guide grooves. The drug outlet pipe extends into the accommodation channel and abuts against the end of the positioning part away from the nozzle. Alternatively, in other embodiments, the positioning part can not be provided. A groove is arranged at the connecting end of the shunt part. The connecting end abuts against the drug outlet pipe so that the drug flowing out of the drug outlet pipe directly enters the gap.

[0028] The spray assembly of the present application has the following beneficial effects. The spray assembly of the present application is provided with a shunt member on the shunt part to shunt the drug in the accommodation channel, thereby avoiding the situation that the drug is gathered on one side of the accommodation channel and the drug is missing on the other side. The converging groove is arranged to have a proximal end larger in size than a distal end to pressurize and equalize the pressure of the drug. When the drug is sprayed from the injection hole, the spray cross section is circular, and the spray central axis is basically consistent with the axial direction of the spray assembly, thereby avoiding the deviation of the spray direction. At the same time, the amount of drug sprayed each time can be basically consistent, thereby ensuring the accuracy and consistency of the drug administration amount and improving the therapeutic effect of the drug.

[0029] The technical solutions of the present application will be described in detail below in combination with the drawings and specific embodiments. BRIEF DESCRIPTION OF DRAWINGS

[0030] Fig. 1 is a schematic view of the spraying of a prior art nasal spray device.

[0031] Fig. 2 is a perspective view of a nasal spray device according to a preferred embodiment of the present application.

[0032] Fig. 3 is an exploded view of the nasal spray device of Fig. 2.

[0033] Fig. 4 is a perspective view of the spray head of Fig. 3.

[0034] Fig. 5 is a cross-sectional view of the spray head of Fig. 4.

[0035] Fig. 6 is a cross-sectional view of the nasal spray device of Fig. 2.

[0036] Fig. 7 is a perspective view of the vortex portion of Fig. 5.

[0037] Fig. 8 is a cross-sectional view of the vortex portion of Fig. 7.

[0038] Fig. 9 is a perspective view of the flow splitter portion of Fig. 3.

[0039] Fig. 10 is a perspective view of another embodiment of the flow splitter portion of Fig. 3.

[0040] Fig. 11 is a cross-sectional view of the flow splitter portion of Fig. 9.

[0041] Fig. 12 is a perspective view of the positioning portion of Fig. 3 from a first perspective.

[0042] Fig. 13 is a perspective view of the positioning portion of Fig. 3 from a second perspective.

[0043] Fig. 14 is a schematic view of the spray effect of the nasal spray device of the present application.

[0044]

BRIEF DESCRIPTION OF DRAWINGS

[0045] In order to make the purpose, technical scheme and advantages of the present application clearer, the present application will be described in detail below with reference to the drawings and specific embodiments.

[0046] 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, "axial line" is understood as the central axis of the nasal spray device 100, i.e. the central axis of the medicine outlet pipe 111 in the length direction, and "circumferential direction" is understood as the circumferential direction centered on the axial line. In the description of the orientation or positional relationship, it is only a simplified description for the convenience of describing the present application, and does not indicate or imply that the device or element referred to must have a specific orientation. The "offset angle" is understood as the included angle less than or equal to 90° formed between the central axis of the spray and the plane where the spray hole is located. "About" or "approximately" can be understood as indicating substantial equivalence or substantial closeness to the numerical value, for example, the numerical difference can be ±5%, preferably ±2%, more preferably ±1%.

[0047] Please refer to FIG. 2 and FIG. 3, the present application discloses a nasal spray device 100, part of the nasal spray device 100 can extend into the nasal cavity, for spraying medicine into the nasal cavity, specifically spraying medicine into the upper nasal meatus olfactory region of the nasal cavity, so that the medicine can be deposited in the upper nasal meatus olfactory region and enter the brain through the upper nasal meatus olfactory region, thereby treating diseases related to the central nervous system.

[0048] The nasal spray device 100 comprises a separable or inseparable medicine storage assembly 1 and a spray 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 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 to suck the medicine in the medicine storage bottle 12 when the medicine storage bottle 12 is inverted (with the bottle mouth downward).

[0049] In the present application, the medicine can be a gaseous medicine, a liquid water medicine, a liquid oil medicine, a liquid emulsion medicine, a solid powder medicine, etc. Meanwhile, a pressurized gas can be filled in the medicine storage bottle 12 according to actual needs to drive the medicine to be outputted outward by the pump body 11.

[0050] 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.

[0051] In the present application, the pump body 11 can be a conventional or unconventional pump body such as a manual pressing type spray pump or an electric spray pump, 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.

[0052] The pump body 11 is further provided with a medicine outlet pipe 111, one end of which is connected with the output port of the pump body 11, and the other end can abut or connect with the spray assembly 2 to deliver the medicine in the medicine storage bottle 12 to the spray assembly 2, and then spray it outward through the spray assembly 2. The medicine outlet pipe 111 can also be integrally arranged with the pump body 11, which is not limited here.

[0053] As shown in FIGS. 3, 5 and 6, the spray assembly 2 comprises 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, and the flow dividing part 4 and the positioning part 5 are received in the receiving channel 31. Meanwhile, a gap (not shown) for the medicine to pass through is arranged 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 is sprayed outward.

[0054] The size of the medicine outlet pipe 111 matches the accommodation channel 31, so that the medicine outlet pipe 111 can extend into the accommodation channel 31 and be tightly connected with the accommodation channel 31, avoiding the medicine from overflowing out of the connection between the medicine outlet pipe 111 and the nozzle 3 during the medicine administration. Preferably, the medicine outlet pipe 111 is connected with the accommodation channel 31 in an interference fit. Of course, in other embodiments, a sealing element can be arranged between the medicine outlet pipe 111 and the accommodation channel 31, or the medicine outlet pipe 111 and the nozzle 3 are connected through the sealing element to improve the sealing effect of the connection and prevent the medicine from flowing out of the connection between the medicine outlet pipe 111 and the accommodation channel 31, which is not limited here.

[0055] Referring to FIGS. 4 and 5, the nozzle 3 includes an extending portion 34, a limiting portion 33, and a pressing portion 32, wherein the extending portion 34, the limiting portion 33, and the pressing portion 32 are distributed in a stepped manner, the limiting portion 33 is arranged between the extending portion 34 and the pressing portion 32 and is fixedly connected with the extending portion 34 and the pressing portion 32, respectively, and specifically, the extending portion 34, the limiting portion 33, and the pressing portion 32 are designed in an integrated manner.

[0056] The shape of the extending portion 34 is similar to a circular truncated cone, and in the direction from the proximal end of the extending portion 34 to the distal end, the outer diameter of the extending portion 34 extends in a shrinking manner, so as to be inserted into the nasal cavity of the patient, wherein the edge position of the distal end of the extending portion 34 is designed as an arc shape, avoiding the damage to the mucosa in the nasal cavity of the patient caused by the edges of the extending portion 34, thereby improving the comfort of the patient during the medicine administration. Specifically, the diameter of the proximal end of the extending portion 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 portion 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 portion 34 is 10-18 mm, preferably 10-17 mm, more preferably 12-17 mm or 12-15 mm, and more preferably 15 mm.

[0057] The limiting portion 33 includes a limiting platform 331 arranged at the distal end of the limiting portion 33, the limiting platform 331 is arranged around 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, thereby improving the deposition rate of the medicine in the upper nasal cavity of the patient. 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.

[0058] Specifically, the limiting portion 33 is designed in a similar manner to a circular truncated cone. In a direction from the proximal end of the limiting portion 33 to the distal end, the limiting portion 33 extends in a contracting manner, 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 designed in an arc shape. On the one hand, this improves the aesthetic appearance of the nozzle 3. On the other hand, it avoids damage to the patient's nasal column and / or alae nasi caused by the limiting platform 331. Of course, in other embodiments, the limiting portion 33 can be designed in a cylindrical shape, extend in an expanding manner in a direction from the proximal end to the distal end, or the like. The limiting portion 33 can also be designed only as a circular ring, an elliptical ring, or the like in the shape of the limiting platform 331, as long as the limiting platform 331 can abut against the patient's nasal column and / or alae nasi and limit the distance of insertion of the extending portion 34 into the patient's nasal cavity. The shape of the limiting portion 33 is not limited herein.

[0059] 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 designed in a cylindrical shape. The pressing portion 32 includes a pressing platform 321 fixedly connected to the limiting portion 33. The pressing platform 321 extends in a 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 medicine, the fingers abut against the pressing platform 321 and the medicine storage bottle 12, respectively, and squeeze the pump body 11 to pump the medicine in the medicine storage bottle 12 outward.

[0060] In this embodiment, the pressing platform 321 is designed in a ring shape. The plane on which the pressing platform 321 is located is perpendicular to the axis of the nasal spray device 100. An arc-shaped transition portion is arranged at the connecting portion between the pressing platform 321 and the limiting portion 33. This makes the overall appearance more beautiful and improves the comfort of the patient during use. Of course, in other embodiments, the plane on which the pressing platform 321 is located can be arranged at an acute angle with the axis. An arc-shaped recess can also be arranged on the pressing platform 321 to facilitate the patient's finger to hold. This is not limited herein.

[0061] The pressing portion 32 further includes a connecting cavity 322 in communication with the accommodating channel 31. The circumferential size of the connecting cavity 322 matches the circumferential size of the pump body 11 or the medicine storage bottle 12. This allows the pressing portion 32 to 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 the liquid medicine outward. 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, damage to the nozzle 3 or the medicine outlet pipe 111 caused by uneven stress is avoided. At the same time, the connecting portion between the medicine storage assembly 1 and the spraying assembly 2 is covered by the pressing portion 32. On the one hand, this makes the external appearance of the nasal spray device 100 more beautiful. On the other hand, it avoids contamination of the connecting portion by external pollutants.

[0062] Please refer to the shown in Figure 5, Figure 7 and Figure 8, the nozzle 3 also includes a vortex portion 35 provided in the receiving channel 31 and located at the distal end of the protruding portion 34, the shunt portion 4 is received in the receiving channel 31 and abuts the vortex portion 35, that is, the vortex portion 35 is provided between the inner wall of the nozzle 3 and the shunt portion 4. The end face at the distal end of the protruding portion 34 is also provided with a spray hole 341, the spray hole 341 penetrates the protruding portion 34 and communicates with the receiving channel 31, the spray hole 341 is opened on the axis of the nozzle 3 and is located at the center position of the vortex portion 35, so that the drug flowing through the spray hole 341 is sprayed outward.

[0063] In the technical solution, the shape of the spray hole 341 is not limited (it can be set as a regular shape such as a rectangle, a circle, a diamond, etc. Generally, in order to make the spray angle more uniform, a circle is preferred), the diameter of the spray hole 341 or the diameter of its inscribed circle can be 0.15-0.22mm, preferably 0.15-0.2mm or 0.2-0.22mm, more preferably 0.2mm, the thickness (length in the axis direction) of the spray hole 341 is 0.15-0.25mm, preferably 0.15-0.2mm or 0.2-0.22mm, more preferably 0.2mm.

[0064] The vortex portion 35 includes at least one structural member 351, which extends from the inner wall of the receiving channel 31 towards the inside of the receiving channel 31. Specifically, the structural member 351 is designed in an "L" shape, that is, one part extends from the side wall of the receiving channel 31 towards the inside of the receiving channel 31, and the other part extends from the end face of the receiving channel 31 towards the inside of the receiving channel 31.

[0065] In the embodiment, three structural members 351 are provided, which are uniformly distributed in the receiving channel 31. Of course, in other embodiments, the structural member 351 can be provided with only one, or two, or four, etc., which can be designed according to actual needs, which is not limited here.

[0066] The vortex portion 35 also includes a receiving cavity 353. Specifically, the receiving cavity 353 is formed by the "L" shaped structural member 351, and the diameter of the receiving cavity 353 is smaller than that of the receiving channel 31, one end of the receiving cavity 353 communicates with the spray hole 341, and the other end communicates with the receiving channel 31.

[0067] As shown in FIG. 9, the flow distribution part 4 comprises a flow distribution column 43, the length of the flow distribution column 43 in the axial direction is the same as that of the flow distribution part 4, and one end of the flow distribution column 43 close to the spray 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 can be tightly connected with the cavity wall of the accommodation cavity 353, so as to realize the connection between the flow distribution part 4 and the spray head 3. Specifically, the diameter of the abutting end 431 is 1.5-2.75 mm, preferably 2.0 mm, and correspondingly, the diameter of the accommodation cavity 353 is the same as that of the abutting end 431.

[0068] The vortex part 35 further comprises a vortex passage 36 formed by the structural member 351, one end of the vortex passage 36 is communicated with the spray hole 341, and the other end can be communicated with the accommodation passage 31, specifically, the other end is communicated with the gap between the inner wall of the accommodation passage 31 and the flow distribution part 4, so that the drug can flow through the gap and the vortex passage 36 and then be sprayed out from the spray hole 341.

[0069] Specifically, the vortex passage 36 comprises a flow guide groove 359, a vortex groove 354 and a vortex cavity 358, wherein the vortex cavity 358 is communicated with the spray hole 341, and the spray hole 341 is located at the center position of the vortex cavity 358, the vortex groove 354 is communicated with the vortex cavity 358, and the vortex groove 354 is arranged in the tangent direction of the vortex cavity 358, that is, the vortex groove 354 and the vortex cavity 358 are arranged in the same plane. The flow guide groove 359 is communicated with the vortex groove 354, and the opening direction of the flow guide groove 359 is perpendicular to the opening direction of the vortex groove 354. Specifically, the flow guide groove 359, the vortex groove 354 and the vortex cavity 358 are formed by the structural member 351, the flow distribution column 43 and the inner wall of the accommodation passage 31. That is, the size of the accommodation cavity 353 is related to the vortex groove 354 and the vortex cavity 358, and the distance between one 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.

[0070] The vortex groove 354 is formed by the adjacent two structural members 351, the inner wall of the accommodation passage 31 and the end face of the abutting end 431. Specifically, the vortex groove 354 comprises a first flow guide surface 355, a second flow guide surface 356 and a ring surface 357, wherein the first flow guide surface 355 and the second flow guide surface 356 are respectively the side wall surfaces of the adjacent two structural members 351, 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 ring surface 357, and the arrangement direction of the second flow guide surface 356 is the tangent direction of the ring surface 357, and the ring surface 357 is designed in an arc shape and forms the vortex cavity 358.

[0071] 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 a, and the vortex angle a is 14-30°, preferably 22°. The thickness (length in the axial direction) of the vortex groove 354 is 0.1-0.25 mm, preferably 0.15-0.25 mm, and more preferably 0.25 mm.

[0072] 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 surface of the abutting end 431. The vortex cavity 358 is designed in a cylindrical shape, and the jet 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 0.5-2.0 mm, and preferably 1.0 mm.

[0073] 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 diameter corresponding to the annular surface 357 is smaller than the diameter of the vortex cavity 358. In this way, after the drug passes through the annular surface 357, it becomes spiral and quickly reaches the jet hole 341. As long as the drug can pass through the annular surface 357 into the vortex cavity 358 and form a spiral in the vortex cavity 358 under the guidance of the annular surface 357, the shape of the annular surface 357 is not limited.

[0074] The drainage groove 359 is formed by the structural member 351, the inner wall of the accommodation channel 31, and the side surface of the abutting end 431, that is, the setting direction of the drainage groove 359 is the same as the axial 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 drug solution can flow from the drainage groove 359 into the vortex groove 354, and after being accelerated by the converging vortex groove 354, it is guided by the arc-shaped annular surface 357 to the vortex cavity 358. Since the vortex groove 354 is arranged on the tangent line of the vortex cavity 358, the drug solution flowing out of the vortex groove 354 can flow spirally in the vortex cavity 358, and finally flow through the jet hole 341 and be ejected outward. By accelerating and spirally flowing the drug, the spray angle and particle size of the drug can be controlled.

[0075] In the embodiment, the vortex grooves 354 and the flow guide grooves 359 can be provided with three, respectively arranged between two adjacent structural members 351, and the three vortex grooves 354 and the three flow guide grooves 359 are respectively distributed in a rotational symmetry around the jet orifice 341, and the annular surface 357 can also be provided with three, and the three annular surfaces 357 are part of the cavity wall of the vortex cavity 358. Of course, in other embodiments, the structural member 351 can be provided with two or more than three, and here, the structural member 351 is provided with two as an example, that is, the three structural members 351 are connected to form a whole, and at this time, the flow guide grooves 359 and the vortex grooves 354 are provided with two, and the liquid medicine can also flow in a spiral manner in the vortex cavity 358; or other numbers of flow guide grooves 359, vortex grooves 354 and structural members 351 can be set according to actual requirements, as long as the vortex grooves 354 are arranged in the tangent direction of the vortex cavity 358, and the vortex grooves 354 are designed in a converging manner, which is not limited here.

[0076] In the embodiment, the flow distribution column 43 and the vortex portion 35 are detachably connected, the structural member 351 and the nozzle 3 are integrally formed, and the vortex passage 36 is formed 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 vortex passage 36 can be embedded in the structural member 351, without being jointly surrounded by other structures, which is not limited here.

[0077] Please refer to FIG. 9 and FIG. 11 in combination with FIG. 7, the flow distribution portion 4 further comprises flow distribution pieces 41 protruding outward from the flow distribution column 43 and flow convergence grooves 42 arranged between two adjacent flow distribution pieces 41, when the flow distribution portion 4 is accommodated in the accommodation channel 31, at least part of the flow distribution pieces 41 away from the side surface of the flow distribution column 43 can tightly abut with the side wall of the accommodation channel 31 to connect the flow distribution portion 4 and the nozzle 3.

[0078] The distal end of the flow distribution piece 41 is provided with a stepped surface 411, which is arranged at the proximal end of the abutting end 431, and 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 structural member 351 can abut with the flow distribution piece 41, specifically, the stepped surface 411 tightly abuts and connects with the abutting table 352, to avoid the flow of the medicine between two adjacent flow convergence grooves 42.

[0079] The proximal end of the flow distribution member 41 is provided with a flow distribution end 412 to distribute the drug in the gap. In some preferred embodiments, the flow distribution end 412 can be provided in the shape of an arc, a cone or a trapezoid, etc., so as to further stabilize and evenly distribute the flow of the drug, avoid local turbulence of the drug and reduce the air bubbles that can be generated in the drug, further improve the stability of the amount of drug administered each time and reduce the inter-subject difference in the amount of drug administered (for example, the inter-subject difference is less than 5% of the average value or the inter-subject relative standard deviation can be less than 5%).

[0080] In this embodiment, three flow distribution members 41 are provided, and the three flow distribution members 41 are uniformly distributed in the circumferential direction of the flow distribution column 43. Of course, in other embodiments, the flow distribution members 41 can be provided in two or more than three, and can be uniformly or non-uniformly distributed in the circumferential direction of the flow distribution column 43, as long as the drug in the gap can be distributed, which is not limited here.

[0081] Specifically, by providing the flow distribution member 41 on the flow distribution portion 4, the drug in the gap can be evenly distributed into the flow collection groove 42 in different directions, reducing the turbulence generated during the flow of the drug, specifically, the drug is uniformly divided, thereby reducing the surface tension of the drug and achieving the reduction of turbulence. Such arrangement can also prevent the drug from excessively gathering on one side of the flow distribution portion 4 and causing drug shortage or pressure significantly lower than other areas on the other side due to the inclination of the device or uneven drug pressure.

[0082] The flow collection groove 42 extends from the proximal end of the flow distribution portion 4 towards the distal end direction, the circumferential size of the proximal end of the flow collection groove 42 is greater than that of the distal end of the flow collection groove 42, and the distal end of the flow collection groove 42 can communicate with the jet hole 341, so that the drug flows through the flow collection groove 42 and can be collected at the jet hole 341 and then sprayed outward. Specifically, the extension direction of the flow collection groove 42 and the arrangement direction of the flow distribution member 41 are the same as the axial direction, the distal end of the flow collection groove 42 can communicate with the vortex channel 36, and the drug flows through the flow collection groove 42 and the vortex channel 36, then is collected at the jet hole 341 and sprayed outward through the jet hole 341.

[0083] Specifically, as shown in FIG. 9, the flow collection groove 42 includes a flow distribution segment 421, a flow collection segment 422 and a flow-out segment 423, wherein the flow distribution segment 421 and the flow-out segment 423 communicate through the flow collection segment 422, the flow distribution segment 421 is arranged at the proximal end of the flow distribution portion 4, the flow-out segment 423 is arranged at the distal end of the flow distribution portion 4, and the end of the flow-out segment 423 away from the flow distribution segment 421 communicates with the vortex channel 36. Specifically, the thickness (length perpendicular to the axial direction) of the flow collection groove 42 is 0.2-0.35 mm, preferably 0.25-0.3 mm, and more preferably 0.3 mm.

[0084] In the circumferential direction of the flow distribution part 4, the flow distribution angle γ corresponding to the flow distribution section 421 is 60-95°, preferably 70-90°, more preferably 80-90°, and most preferably 90°; and the outflow angle θ corresponding to the outflow section 423 is 25-35°, preferably 25-30° or 30-35°, and more preferably 30°. In this embodiment, the flow collection groove 42 is arranged in an arc shape. Of course, in other embodiments, the flow collection groove 42 can be arranged in a planar shape. In this case, the flow distribution angle γ and the outflow angle θ are the angles corresponding to the inscribed or circumscribed arc of the flow collection groove 42.

[0085] In this embodiment, in order to facilitate the description of the dimensions of the flow distribution section 421 and the outflow section 423 in the circumferential direction, the angles corresponding to the arc-shaped flow distribution section 421 and the arc-shaped outflow section 423 are described. At the same time, the diameter of the arc-shaped flow distribution section 421 is the diameter of the flow distribution column 43. In this application, the diameter of the flow distribution column 43 is 1.5-2.75 mm, and preferably 2.0 mm.

[0086] In the axial direction of the flow distribution part 4, the opposite groove walls of the flow distribution section 421 and the outflow section 423 are arranged in parallel, and the flow collection section 422 is arranged in an arc-shaped constricted shape, i.e., the two opposite groove walls of the flow collection section 422 are arranged in an arc shape and symmetrically. By arranging the flow collection section 422 in an arc shape, the pressure at the flow collection section 422 is increased. At the same time, the arc-shaped flow collection section 422 can exert a counterforce on the drug, which helps to reduce the amount of drug flowing into the flow collection groove 42 with high inflow pressure. In this way, the drug pressure in the flow collection grooves 42 in different directions is balanced, ensuring that the drug flowing out of the flow collection grooves 42 in different directions has the same or similar pressure. Of course, in other embodiments, only one side of the flow collection section 422 can be arranged in an arc shape, which is not limited here.

[0087] The length of the flow distribution part 41 in the axial direction is less than the length of the flow distribution column 43 in the axial direction. Specifically, in the axial direction of the flow distribution part 4, the length of the flow distribution section 421 is 7.5-11.5 mm, preferably 7.5-9.0 mm or 9.0-11.5 mm, and more preferably 9.5 mm; the length of the outflow section 423 is 1.65-2.05 mm, preferably 1.65-1.85 mm or 1.85-2.05 mm, and more preferably 1.85 mm; the diameter of the flow collection section 422 is 1.5-2.5 mm, preferably 2.0-2.3 mm, and more preferably 2.0 mm; and the length of the abutting end 431 is 2.0-3.5 mm, preferably 2.5-3.0 mm, and more preferably 2.5 mm.

[0088] In the embodiment, the length of the shunt column 43 is 21.5-31.5 mm, preferably 26.5 mm; of course, in other embodiments, the length of the shunt column 43 can be other values, as long as the value is greater than the sum of the length of the shunt 41 and the abutting end 431, and the shunt end 412 does not abut other structures, which is not limited here.

[0089] In the embodiment, in the axial direction, the two side groove walls opposite to the shunt section 421 and the outflow section 423 are arranged in parallel, and the medicine is pressurized by the confluence section 422; of course, in other embodiments, the confluence section 422 can not be provided, please refer to FIG. 10, the shunt section 421 and the outflow section 423 are directly connected, and the shunt section 421 and the outflow section 423 are designed to be gradually reduced in the direction from the proximal end to the distal end of the shunt part 4. At this time, the shunt section 421 and the outflow section 423 together form the confluence groove 42, and the shunt section 421 and the outflow section 423 together pressurize the medicine. The maximum value of the shunt angle γ corresponding to the shunt section 421 is 60-95°, preferably 70-90°, more preferably 80-90°, and most preferably 90°; the minimum value of the outflow angle θ corresponding to the outflow section 423 is 25-35°, preferably 25-30° or 30-35°, more preferably 30°. At the same time, the shunt section 421 and the outflow section 423 have no clear boundary line, as long as the shunt angle γ and the outflow angle θ meet the above conditions to pressurize and equalize the pressure of the medicine, avoiding the effect that the outflowing medicine has a pressure difference. Of course, it can also be designed that the shunt section 421 and the outflow section 423 are connected through the confluence section 422, and the shunt section 421 and the outflow section 423 are designed to be gradually reduced in the direction from the proximal end to the distal end of the shunt part 4.

[0090] In the embodiment, the confluence groove 42 corresponding to the shunt part 41 is provided with three, and the three confluence grooves 42 are uniformly distributed in the circumferential direction of the shunt part 4. Of course, in other embodiments, the confluence groove 42 can also be provided with two or more than three corresponding to the shunt part 41, and each confluence groove 42 can communicate with the vortex channel 36, so that the medicine can enter the vortex channel 36 through the confluence groove 42. The number of the confluence groove 42 is not limited here.

[0091] Please refer to FIGS. 6, 12 and 13, 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. The connecting end 432 of the shunt part 4 extends into the positioning hole 51 to realize the connection of 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. On the one hand, it is convenient for positioning connection with the positioning hole 51, and on the other hand, it makes the medicine flowing through the connecting end 432 flow uniformly.

[0092] The outer side of the positioning part 5 is provided with flow guide strips 52 and flow guide grooves 53 distributed at intervals, wherein the flow guide strips 52 and the flow guide grooves 53 are arranged along the axis direction, the outer wall surface of the flow guide strip 52 can accommodate the inner wall surface of the accommodation channel 31 closely, so as to avoid the positioning part 5 from sliding out of the accommodation channel 31.

[0093] The end of the positioning part 5 away from the nozzle 3 is provided with a recess 54, and the recess 54 is arranged in the shape of a cross. The end of the recess 54 away from the axis is in communication with the flow guide groove 53 in a corresponding manner. When the ejection assembly 2 is connected with the medicine storage assembly 1, the medicine outlet pipe 111 extends into the accommodation channel 31 and abuts against the end of the positioning part 5 away from the nozzle 3. The medicine outlet pipe 111 pumps the medicine outward, and the medicine flows to the flow guide groove 53 along the recess 54, and then flows into the gap between the flow distribution column 43 and the accommodation channel 31.

[0094] In the embodiment, the ejection assembly 2 comprises the positioning part 5, which is used to abut against the medicine outlet pipe 111 and maintain the stability of the flow distribution part 4 in the accommodation channel 31. Of course, in other embodiments, the positioning part 5 can not be provided. In this case, the recess 54 is arranged at the connection end 432 of the flow distribution part 4, and the connection end 432 abuts against the medicine outlet pipe 111, so that the medicine flowing out of the medicine outlet pipe 111 directly enters the gap. At the same time, the sealing connection between the medicine outlet pipe 111 and the accommodation channel 31 can also be achieved by a sealing member, which is not limited herein.

[0095] Experimental part:

[0096] The angle less than or equal to 90° formed between the central axis of the spray and the plane where the spray hole is located is defined as the deviation angle δ. The inventor tested the existing nasal spray devices on the market and found that the spray directions of the existing nasal spray devices deviated obviously (i.e., the deviation angle δ was less than or equal to 85°) to different degrees, and the amount of medicine sprayed each time was quite different from the standard spray weight (i.e., the difference between the single spray weight and the standard spray weight was greater than 5 mg).

[0097] The existing nasal spray devices on the market (with specifications of 50 μL, 100 μL and 150 μL, and standard spray weights of 50 mg, 100 mg and 150 mg, respectively) were tested. Each device was sprayed 5 times, and the deviation angle and the single spray weight of each spray were tested, and the data are as follows:

[0098] In the 50 μL nasal spray device test data, there are four tests with a deviation angle δ less than 85° and a spray weight difference from the standard spray weight beyond the range of ±5% of the standard spray weight. In the 100 μL nasal spray device test data, there are four tests with a deviation angle δ less than 85° or a spray weight difference from the standard spray weight beyond the range of ±5% of the standard spray weight. In the 150 μL nasal spray device test data, there are five tests with a deviation angle δ less than 85° or a spray weight difference from the standard spray weight beyond the range of ±5% of the standard spray weight.

[0099] Overall, the spray direction deviation of the existing nasal spray device is obvious (i.e., the deviation angle δ is too small), the difference between the spray weight and the standard spray weight is large, and under the same test conditions, the difference between multiple test data is large, and the stability is extremely poor.

[0100] Based on the long-term research and development experience in the medical device field and the research on the existing device, the inventor team preliminarily determines that the deviation angle δ is greater than 85°, which can avoid the direct contact and deposition of the drug with the nasal wall, and the spray weight within the range of ±5% of the standard spray weight is qualified, and the spray weight is the amount of drug sprayed in a unit of time, i.e., the amount of drug sprayed by pressing the nasal spray device once.

[0101] To this end, the inventor team improves the existing nasal spray device and tests to obtain a nasal spray device 100 (the standard spray weight is 100 mg) with a deviation angle δ greater than 85°, and preferably close to 90° and stable, and the amount of drug sprayed each time is stable at about 100 mm, as shown in FIG. 14. The drug used in the test process is a solution, and the liquid viscosity is between 0.96-1.1 Pa·s. The values of the deviation angle δ and the spray weight are the average values of three test results under the same conditions.

[0102] Test method and instrument of the deviation angle δ:

[0103] Instrument name: Oxford laser particle size analyzer

[0104] Model: Imaging Division

[0105] 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. Turn on the instrument and check the instrument calibration mark to confirm that the instrument is within the calibration period.

[0106] Turn on the trigger software, set the trigger parameters, and click start. By collecting the spray image, using image algorithm for image recognition, and calculating the spray angle through the binary image, 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, and the digital measurement of the nozzle atomization angle is realized.

[0107] Record the spray angle data, calculate the angle between the angle bisector of the spray and the horizontal plane of the nozzle, which is the offset angle δ, record and save the data.

[0108] Test method and instrument for spray weight:

[0109] Instrument name: ten millionth electronic balance

[0110] Model: XS205DU

[0111] Leveling: Before using the balance, observe whether the water bubble in the back level of the balance is in the center of the ring. If not, adjust it by the balance foot bolts, left-handed to raise, right-handed to lower, and make sure the balance is placed horizontally.

[0112] Preheating: When the balance is powered on for the first time or after a long power-off, preheat for 30 minutes.

[0113] Weighing: Turn on the display by pressing the ON / OFF key, and wait for the instrument to self-check. When the display shows zero, the self-checking process is complete, and you can proceed to weigh. Place the weighing paper, press the Tare key on both sides of the display, and when the display shows zero, add the reagent to be weighed on the weighing paper. Weigh the mass of the spray before and after the spray, and the difference between the before and after single spray is the single spray weight.

[0114] Example 1

[0115] In this embodiment, the effects of the diversion angle γ and the outflow angle θ on the offset angle δ and the spray weight are tested, wherein other parameters of the diversion part 4 can be set according to existing devices or actual conditions (for example, the thickness of the confluence groove 42 is set to 0.3 mm, the length of the diversion section 421 is set to 9.5 mm, the length of the outflow section 423 is set to 1.85 mm, and the length of the abutting end 431 is set to 2.5 mm, etc.), and other structural parameters of the nasal spray device 100 refer to the values of existing devices.

[0116] The experimental data are as follows:

[0117] From the experimental data, it can be seen that the values of the diversion angle γ and the outflow angle θ have a great influence on the offset angle δ and the spray weight, wherein when the diversion angle γ is 60-95° and the outflow angle θ is 25-35°, the offset angle δ is greater than 85° and the spray weight is within the standard spray weight ±5% range (i.e. between 95-105 mg), which meets the qualified standard; and the inventors have also found that when the diversion angle γ is 60-95° and the outflow angle θ is 25-35°, the offset angle δ and the spray weight of single spray both meet the qualified standard. Specifically, when the diversion angle γ is 80-90° and the outflow angle θ is 30°, the offset angle δ is closest to 90° and the spray weight is closest to 100 mg.

[0118] Example 2

[0119] In this embodiment, the influence of the diameter of the confluence section 422 on the deflection angle δ and the spray weight is tested when the confluence section 422 is present in the confluence groove 42, the diameter of the confluence section 422 is set to 1.5 mm, 2.0 mm, 1.3 mm, and 1.5 mm respectively, the split angle γ is set to 90°, the outflow angle θ is set to 30°, and other parameters of the split section 4 can be set according to actual conditions with reference to the device of Example 1, and other structural parameters of the nasal spray device 100 can be set according to actual conditions with reference to the device of Example 1.

[0120] Through experimental testing, when the diameter of the confluence section 422 is between about 1.5-2.5 mm, the deflection angle δ is greater than 85° and the spray weight is within the standard spray weight ±5% range (i.e. between 95-105 mg), which meets the qualified standard. When the diameter of the confluence section 422 is about 2.00 mm, the deflection angle δ is about 90° and the spray weight is about 100 mg.

[0121] Example 3

[0122] In this embodiment, the influence of the thickness of the confluence groove 42 on the deflection angle δ and the spray weight is tested, the thickness of the confluence groove 42 is set to 0.20 mm, 0.25 mm, 0.30 mm, and 0.35 mm respectively, the split angle γ is set to 90°, the outflow angle θ is set to 30°, and other parameters of the split section 4 can be set according to actual conditions with reference to the device of Example 1, and other structural parameters of the nasal spray device 100 can be set according to actual conditions with reference to the device of Example 1.

[0123] Through experimental testing, when the thickness of the confluence groove 42 is between 0.20-0.35 mm, the deflection angle δ is greater than 85° and the spray weight is within the standard spray weight ±5% range (i.e. between 95-105 mg), which meets the qualified standard. When the thickness of the confluence groove 42 is about 0.30 mm, the deflection angle δ is about 90° and the spray weight is about 100 mg.

[0124] Example 4

[0125] In this embodiment, the influence of the length of the split section 421 on the deflection angle δ and the spray weight is tested, the length of the split section 421 is set to 7.5 mm, 8.5 mm, 9.5 mm, 10.5 mm, and 11.5 mm respectively, the split angle γ is set to 90°, the outflow angle θ is set to 30°, and other parameters of the split section 4 can be set according to actual conditions with reference to the device of Example 1, and other structural parameters of the nasal spray device 100 can be set according to actual conditions with reference to the device of Example 1.

[0126] Experimental tests show that when the length of the flow diversion section 421 is between 7.5-11.5 mm, the offset angle δ is greater than 85° and the spray weight is within the range of ±5% of the standard spray weight (i.e. between 95-105 mg), which meets the qualified standard. When the length of the flow diversion section 421 is about 9.5 mm, the offset angle δ is about 90° and the spray weight is about 100 mg.

[0127] Example 5

[0128] In this embodiment, the effects of the length of the outflow section 423 on the offset angle δ and the spray weight are tested. The length of the outflow section 423 is set to 1.65 mm, 1.85 mm, and 2.05 mm, respectively. The flow diversion angle γ is set to 90°, the outflow angle θ is set to 30°, and other parameters of the flow diversion portion 4 can be set according to actual conditions with reference to the device of Example 1. Other structural parameters of the nasal spray device 100 can also be set with reference to the device of Example 1 or according to actual conditions.

[0129] Experimental tests show that when the length of the outflow section 423 is between 1.65-2.05 mm, the offset angle δ is greater than 85° and the spray weight is within the range of ±5% of the standard spray weight (i.e. between 95-105 mg), which meets the qualified standard. When the length of the outflow section 423 is about 1.85 mm, the offset angle δ is about 90° and the spray weight is about 100 mg.

[0130] Example 6

[0131] In this embodiment, the effects of the length of the abutment end 431 on the offset angle δ and the spray weight are tested. The length of the abutment end 431 is set to 2.0 mm, 2.5 mm, 3.0 mm, and 3.5 mm, respectively. The flow diversion angle γ is set to 90°, the outflow angle θ is set to 30°, and other parameters of the flow diversion portion 4 can be set according to actual conditions with reference to the device of Example 1. Other structural parameters of the nasal spray device 100 can also be set with reference to the device of Example 1 or according to actual conditions.

[0132] Experimental tests show that when the length of the abutment end 431 is between 2.0-3.5 mm, the offset angle δ is greater than 85° and the spray weight is within the range of ±5% of the standard spray weight (i.e. between 95-105 mg), which meets the qualified standard. When the length of the abutment end 431 is about 2.5 mm, the offset angle δ is about 90° and the spray weight is about 100 mg.

[0133] Example 7

[0134] The shunt angle γ in the shunt part 4 is 90°, the outflow angle θ is 30°, the diameter of the confluence section 422 in the confluence groove 42 is 2.0 mm, the thickness of the confluence groove 42 is 0.3 mm, the length of the shunt section 421 is 9.5 mm, the length of the outflow section 423 is 1.85 mm, and the length of the abutment end 431 is 2.5 mm. The other structural parameters of the nasal spray device 100 can refer to the device of Embodiment 1 or be set according to actual conditions.

[0135] After multiple tests, the offset angle δ is about 89.8, only a few times the offset angle is 89.7, the average spray weight is 100.2 mg, specifically 100.2 ± 0.5 mg, that is, under this parameter, the offset angle δ is more optimal and the single spray weight is more stable.

[0136] Embodiment 8

[0137] The shunt angle γ in the shunt part 4 is 90°, the outflow angle θ is 30°, the thickness of the confluence groove 42 is 0.3 mm, the length of the shunt section 421 is 9.5 mm, the length of the outflow section 423 is 1.85 mm, and the length of the abutment end 431 is 2.5 mm, and no confluence section 422 is arranged in the confluence groove 42. The other structural parameters of the nasal spray device 100 can refer to the device of Embodiment 1 or be set according to actual conditions.

[0138] After multiple tests, the offset angle δ is about 89.7, only a few times the offset angle is 89.6, the average spray weight is 100.1 mg, specifically 100.1 ± 0.5 mg, that is, under this parameter, the offset angle δ is more optimal and the single spray weight is more stable.

[0139] In summary, the spray assembly 2 of the present application sets the shunt part 4 with a shunt piece 41 to shunt the medicine in the accommodation channel 31, so that the medicine can enter the confluence groove 42 in different directions basically uniformly, avoiding the situation that the medicine gathers on one side of the accommodation channel 31 and is missing on the other side; by setting the confluence groove 42 to have a proximal end size larger than a distal end size, the confluence groove 42 can pressurize and equalize the pressure of the medicine when the medicine flows in the confluence groove 42, avoiding the pressure difference on both sides of the spray hole 341; by shunting the medicine with the shunt piece 41 and equalizing the pressure of the medicine with the confluence groove 42, the spray cross section presents a circular shape when the medicine is sprayed from the spray hole 341, and the spray direction is basically consistent with the axial direction of the spray assembly 2, avoiding deviation, and at the same time, the amount of medicine sprayed each time can be basically consistent, ensuring the accuracy and consistency of the drug application amount and improving the treatment effect of the medicine.

[0140] The above examples are only used to illustrate the technical solutions of the present application but not limit the present application, and although the present application has been described in detail with reference to the preferable embodiments, those skilled in the art should understand that the technical solutions of the present application can be modified or equivalently replaced, 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) is provided with a receiving channel (31), and the shunt part (4) is received in the receiving channel (31). The shunt part (4) comprises shunt pieces (41) arranged at intervals, and a confluence groove (42) arranged between two adjacent shunt pieces (41). At least part of the shunt pieces (41) can abut against the side wall of the receiving channel (31) to connect the shunt part (4) and the nozzle (3). The confluence groove (42) extends from the proximal end of the shunt part (4) to the distal end direction, and the circumferential dimension of the proximal end of the confluence groove (42) is greater than the circumferential dimension of the distal end of the confluence groove (42). The nozzle (3) comprises a spray hole (341) capable of communicating with the confluence groove (42). The medicine flows through the confluence groove (42) and is collected at the spray hole (341) to be sprayed outward.

2. The spray assembly of claim 1, wherein: The confluence groove (42) comprises a shunt section (421) and an outflow section (423) capable of communicating. The maximum value of the corresponding shunt angle (γ) of the shunt section (421) is 60-95°, and the minimum value of the corresponding outflow angle (θ) of the outflow section (423) is 25-35°.

3. The spray assembly of claim 2, wherein: The confluence groove (42) further comprises a confluence section (422) arranged in an arc-shaped contraction manner. One end of the confluence section (422) communicates with the shunt section (421), and the other end communicates with the outflow section (423). The diameter of the confluence section (422) is 1.5-2.5mm.

4. The spray assembly of claim 3, wherein: The confluence groove (42) is arranged in an arc shape. The shunt angle (γ) is 90°, and the outflow angle (θ) is 30°. And / or, the diameter of the confluence section (422) is 2.0mm.

5. The jet assembly of any one of claims 2 to 4, wherein: The thickness of the confluence groove (42) is 0.2-0.35mm. And / or, the length of the shunt section (421) is 7.5-11.5mm. And / or, the length of the outflow section (423) is 1.65-2.05mm. And / or, the nozzle (3) is provided with a receiving cavity (353). The distal end of the shunt part (4) is provided with an abutting end (431) capable of being received in the receiving cavity (353). The length of the abutting end (431) is 2.0-3.5mm.

6. The spray assembly of claim 5, wherein: The shunt angle (γ) is 90°, and the outflow angle (θ) is 30°. And / or, the thickness of the confluence groove (42) is 0.3mm. And / or, the length of the shunt section (421) is 9.5mm. And / or, the length of the outflow section (423) is 1.85mm. And / or, the length of the abutting end (431) is 2.5mm.

7. The jet assembly of any one of claims 1 to 6, wherein: The nozzle (3) further comprises a vortex part (35) arranged in the receiving channel (31). The vortex part (35) comprises a receiving cavity (353). The shunt part (4) is provided with an abutting end (431) received in the receiving cavity (353) and capable of tightly abutting and connecting with the cavity wall of the receiving cavity (353).

8. The spray assembly of claim 7, wherein: The vortex part (35) comprises a structural part (351) and a vortex channel (36) formed by the structural part (351), the vortex channel (36) is in communication with the injection hole (341), when the structural part (351) is in abutment with the flow dividing part (41), the vortex channel (36) is in communication with the flow collecting groove (42), so that the medicine can flow into the vortex channel (36) through the flow collecting groove (42), and then gather at the injection hole (341) and be sprayed outwards through the injection hole (341).

9. The spray assembly of claim 8, wherein: The distal end of the flow dividing part (41) is provided with a stepped surface (411), the proximal end of the structural part (351) is provided with an abutment table (352), when the abutment end (431) is accommodated in the accommodation cavity (353), the stepped surface (411) is tightly connected with the abutment table (352); And / or, the proximal end of the flow dividing part (41) is provided with a flow dividing end (412) to divide the medicine.

10. The jet assembly of any one of claims 7 to 9, wherein: The flow dividing part (4) comprises a flow dividing column (43), the flow dividing part (41) protrudes outward from the flow dividing column (43).

11. The spray assembly of claim 10, wherein: The flow dividing column (43) is detachably connected with the vortex part (35); or the flow dividing column (43), the vortex part (35) and the spray head (3) are integrally formed; or the flow dividing column (43) and the vortex part (35) are integrally formed.

12. The spray assembly of claim 2, wherein: The flow dividing section (421) and the outflow section (423) are directly connected, and the flow dividing section (421) and the outflow section (423) are gradually reduced in a shrinking shape from the proximal end to the distal end of the flow dividing part (4).

13. The spray assembly of claim 3, wherein: In the axial direction of the flow dividing part (4), the groove walls opposite to each other of the flow dividing section (421) and the outflow section (423) are arranged in parallel; or the flow dividing section (421) and the outflow section (423) are gradually reduced in a shrinking shape from the proximal end to the distal end of the flow dividing part (4).

14. A nasal spray device characterized by: The injection assembly (2) comprises a medicine storage assembly (1) and a spray assembly (2) as claimed in any one of claims 1-13, the medicine storage assembly (1) comprises a medicine storage bottle (12) and a pump body (11) connected with the medicine storage bottle (12), the pump body (11) is provided with an outwardly extending medicine outlet pipe (111), one end of the medicine outlet pipe (111) away from the pump body (11) can be connected with the spray assembly (2) to deliver the medicine in the medicine storage bottle (12) to the spray assembly (2) and then spray outwards.

15. The nasal spray device of claim 14, wherein: The spray 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), the connecting end (432) of the flow dividing part (4) extends into the positioning hole (51), the outer side surface of the positioning part (5) is provided with spaced apart flow guiding strips (52) and flow guiding grooves (53), the medicine outlet pipe (111) extends into the accommodation channel (31) and abuts against one end of the positioning part (5) away from the spray head (3); Alternatively, a groove (54) is arranged at the connecting end (432) of the flow distribution part (4), and the connecting end (432) is in abutment with the medicine outlet pipe (111).

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