Spray head for spraying drug to nasal olfactory region mucosa and apparatus therefor

By designing a specific spray head, using the cyclone groove and water core to form a divergent mist liquid, and ensuring parallelism through the arcuate drug delivery fitting surface, the problem that existing nasal drug delivery equipment cannot accurately locate the olfactory area is solved, and efficient drug delivery and drug delivery parallelism is achieved.

WO2025113132A1PCT designated stage expired Publication Date: 2025-06-05NASAL PHYTO (SZ) PHARMACEUTICAL TECHNOLOGY CO LTD
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Patent Information

Application Number
PCT/CN2024/130453
Authority / Receiving Office
WO · WO
Patent Type
Applications
Current Assignee / Owner
Priority Date
2023-11-30
Filing Date
2024-11-07
Publication Date
2025-06-05

AI Technical Summary

Technical Problem

Existing nasal administration equipment cannot accurately locate the olfactory area, making it difficult to effectively deliver the drug to the central nervous system and poor parallelism of the administration.

Method used

A spray head for spraying drugs into the mucosa of the nasal olfactory area is designed. It adopts an integrated hollow nozzle with a cyclone groove and a water core inside. Through specific structural design and angle settings, a divergent mist liquid is formed, concentrated in the nasal olfactory area to scatter, improve the drug absorption efficiency, and ensure drug delivery parallelism through the arcuate drug delivery fitting surface.

Benefits of technology

It realizes that the drug enters the olfactory area in an efficient atomization form, improves the deposition rate and absorption efficiency of the drug in the nasal cavity, eliminates the problem of non-parallelism during drug administration, and is suitable for active and passive drug administration scenarios.

✦ Generated by Eureka AI based on patent content.

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Abstract

The present utility model relates to a medical device, and in particular, to a spray head for spraying a drug to a nasal olfactory region mucosa and an apparatus therefor. The spray head comprises a spray nozzle, a water core, and a water passing pipe. A closed bow-shaped structure is arranged at one end of an outer side of the spray nozzle. A certain angle A is formed between an arch-shaped plane of the bow-shaped structure and the central axis of the spray nozzle. A horizontal plane tilted upward toward the direction of a spray hole is arranged at a bottom end of the spray nozzle. A certain angle B is formed between the horizontal plane and the central axis of the spray nozzle. By arranging the straight drug liquid acceleration channel, the flow velocity of a drug liquid is increased, and after flowing through a cyclone groove, the drug liquid forms a divergent liquid mist at a specific angle. By means of the design of the bow-shaped structure and the horizontal plane of the spray nozzle, the discrepancies caused by non-standard operation of drug administration personnel are avoided, thereby ensuring the precision and parallelism in nasal mucosal drug delivery during active drug administration and passive drug administration. The present utility model features a simple structure, thus being suitable for industrial production.
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Description

A spray head and device for spraying medicine to nasal olfactory mucosa Technical Field

[0001] The utility model relates to the field of medical equipment, in particular to a spray head for spraying medicine to the mucous membrane of the nasal olfactory region and a device thereof. Background Art

[0002] The blood-brain barrier (BBB) ​​is a major bottleneck for drugs to effectively treat central nervous system diseases. Due to the existence of the BBB, existing routes of administration, such as oral, intravenous, intramuscular, and subcutaneous, are unable to effectively deliver drugs to the central nervous system (CNS). Since drugs cannot effectively cross the BBB, they are unable to effectively treat brain diseases. Furthermore, as the drug dosage increases, so do systemic side effects.

[0003] Administration through the nasal mucosa has been considered a method of drug administration that can be quickly and efficiently absorbed. The olfactory mucosa is located at the top of both sides of the nose and has an area of ​​about 5 to 10 cm. 2 The olfactory mucosa has a thick mucus layer that is unaffected by respiratory airflow. Once drug molecules reach the olfactory mucosa, they are slowly cleared due to a lack of mucus movement. The olfactory epithelium is composed of supporting cells, basal cells, and olfactory cells. Olfactory cells are bipolar neurons, with slender axons extending from their bases, passing through the basement membrane and forming bundles of unmyelinated nerve fibers—olfactory filaments—within the lamina propria. These filaments pass through the cribriform plate of the ethmoid bone and enter the olfactory bulb of the central nervous system. It is precisely the presence of the olfactory mucosa that gives the nasal route of drug administration its unique brain-targeting effect.

[0004] Existing nasal drug delivery devices lack accurate positioning mechanisms. Medical staff or patients consider drug delivery completed when they drip the drug into the nasal cavity. Since the drug is concentrated in the upper nasal passages or nasal septum, it is difficult to locate the olfactory area and thus to achieve a targeted effect in the brain. Due to the irregular operation of different drug delivery personnel, the parallelism of drug efficacy is poor.

[0005] There are only two existing nasal drug delivery devices that can deliver drugs to the upper nasal passages. For multiple sprays, the first device is the nasal drug delivery device from Impel, but this drug delivery device uses a method of adding a propellant to enable the drug to reach the upper nasal passages; the other is the nasal spray disclosed in Figure 4 of CN115068795A, which uses a hand pump or high-pressure air to release the drug so that the drug is atomized through the atomizing nozzle and then enters the patient's upper nasal passage. This type of nasal spray is suitable for use in scenarios where multiple doses are repeatedly administered.

[0006] For some first aid and anesthetic drugs, a single spray is used. The advantages of a single spray nasal spray are: the liquid medicine is extracted only when it is used, which is convenient for long-term storage of the corresponding liquid medicine; the device is discarded after a single use, avoiding contamination of the liquid medicine or the device.

[0007] Currently, for single-spray delivery devices to the upper nasal passage, there's the Aptar single-spray, which uses the method disclosed in CN112512698 A. After puncturing the piston with a steel needle, the drug is then injected using a push syringe. This method requires a steel needle, making it inconvenient to use and resulting in only a 5% to 10% drug deposition rate in the olfactory zone. Another nasal sprayer is the Nafion Pharmaceuticals single-dose sprayer, which uses the method disclosed in CN202320634030.2. During drug delivery, the spray head is slowly rotated until the large surface of the dosing reference horizontal plane is horizontal, then rotation is stopped. Maintaining this horizontal angle, the spray head is slowly inserted along the nasal septum of the recipient to deliver the drug. This single-dose sprayer addresses the parallelism issue to some extent; however, this dosing technique requires the addition of a dosing reference plane and is only suitable for passive drug delivery scenarios, not active drug delivery scenarios. Furthermore, the reference plane must be visually manipulated by the user during drug delivery, which can lead to human error. For different patients and different drug administration personnel, it is necessary to ensure that the drug administration angle of the sprayer is consistent in order to ensure the parallelism of the drug administration effect; therefore, how to provide a spray head and device that sprays drugs into the nasal olfactory mucosa with good atomization effect, high olfactory area deposition rate and good drug administration parallelism has become an urgent problem to be solved. Utility Model Content

[0008] In view of this, the present invention provides a spray head for spraying medicine to the mucous membrane of the nasal olfactory region, comprising:

[0009] The nozzle is a hollow, integrally formed nozzle with a chamber for passage of an external drug source and / or a chamber for placement of an atomization device.

[0010] The atomizing equipment is a water core and / or a water pipe. A spray hole is provided at the center position of the top of the nozzle. A cyclone groove is provided on the inner wall of the top of the nozzle. The center of the cyclone groove is concentric with the spray hole. The water core and the water pipe are fixedly installed in sequence at one end of the nozzle close to the spray hole. The water core, the water pipe, the cyclone groove and the spray hole form an internally connected liquid medicine channel.

[0011] A closed bow-shaped structure is provided at one end of the outer side of the nozzle, and its bow plane forms a certain angle A with the central axis of the nozzle; a horizontal plane tilted toward the nozzle hole is provided at the bottom end of the nozzle, and the horizontal plane forms a certain angle B with the central axis of the nozzle.

[0012] Preferably, the range of the angle A is between 35° and 55°, for example, it can be 35°, 40°, 45°, 50° or 55°; and / or, the range of the angle B is between 40° and 60°, for example, it can be 40°, 45°, 50°, 55° or 60°.

[0013] Preferably, a limiting structure is further provided on the outside of the nozzle, and the distance between the limiting structure and the nozzle hole is 2-3 cm, for example, 2.5 cm.

[0014] Preferably, the water core is integrally formed and is divided into a front end and a rear end of the water core. The diameter of the rear end of the water core is larger than the diameter of the front end of the water core. The rear end of the water core is provided with one or more water grooves for the passage of liquid medicine. The water grooves are concave, and the rear end of the water core is fixedly connected to the side wall of the nozzle by interference fit.

[0015] Preferably, the front end of the water core is uniformly cylindrical, the end surface of the front end of the water core is circular, and forms a vortex chamber with the cyclone groove.

[0016] Preferably, the water pipe is hollow, the side wall of the water pipe is fixedly connected to the side wall of the nozzle by interference fit, and the upper end of the water pipe is connected to the lower end of the water core.

[0017] Preferably, the cyclone groove has three rotating blades, which are evenly distributed along the circumference.

[0018] Preferably, the nozzle is integrally formed of plastic material.

[0019] The utility model also provides a device for spraying medicine to the mucous membrane of the nasal olfactory region, comprising the above-mentioned spray head and a device for providing a medicine source.

[0020] Preferably, the device for providing the drug source is a pusher assembly, which includes a pusher barrel and a push rod. The pusher assembly is detachably arranged in the nozzle.

[0021] Preferably, the device for spraying medicine into the nasal olfactory mucosa is made of PP material.

[0022] Preferably, the head end of the push rod is further provided with a butyl rubber plug.

[0023] Preferably, the tail end of the push rod extends out of the tail end of the injector barrel.

[0024] Preferably, the diameter of the head end of the injector assembly is larger than the diameter of the water pipe.

[0025] Preferably, a detachable quantitative clamp is also provided at the tail end of the push rod, which can accurately quantify the single dosage amount. For example, the quantitative clamp can quantify to 0.05 mL or 0.1 mL.

[0026] Compared with the prior art, the present invention has the following beneficial effects:

[0027] This novel device for spraying medication into the nasal olfactory mucosa features a straight medication acceleration channel, accelerating the flow of the medication. After flowing through the cyclone trough, the medication forms a divergent mist at a specific angle, concentrating and scattering the medication in the nasal olfactory region, making it easier for the mucosa to absorb. This eliminates non-parallelism during drug administration. Whether the medication is administered actively by the patient or passively by medical staff, the arched medication surface rests against the patient's upper lip, and the angle of insertion is consistent each time to ensure parallelism. BRIEF DESCRIPTION OF THE DRAWINGS

[0028] In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the following briefly introduces the drawings required for use in the embodiments. Obviously, the drawings described below are only some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying any creative work.

[0029] FIG1 is a structural diagram of a spray head device provided by the present invention;

[0030] FIG2 is a schematic structural diagram of the push syringe assembly provided by the present invention;

[0031] FIG3 is a structural diagram of a device for spraying medicine into the olfactory mucosa of the nose provided by the present invention;

[0032] FIG4 is a schematic structural diagram of a liquid pipetting head assembly provided by the present invention;

[0033] FIG5 is a schematic structural diagram of the water core provided by the present invention. DETAILED DESCRIPTION

[0034] The determination method of this patent application will be described in further detail below with reference to specific examples. It should be understood that the following examples are merely illustrative and explanations of the present invention and should not be construed as limiting the scope of protection of the present invention. All technologies implemented based on the above content of the present invention are encompassed within the scope of protection that the present invention is intended to protect.

[0035] In the description of this patent application, it should be noted that the terms "center," "upper," "lower," "left," "right," "vertical," "horizontal," "inner," "outer," and the like, indicating orientations or positional relationships, are based on the orientations or positional relationships shown in the accompanying drawings and are intended solely to facilitate the description of this patent application and simplify the description. They are not intended to indicate or imply that the devices or components referred to must have a specific orientation, be constructed, or operate in a specific orientation. Therefore, they should not be construed as limitations on this patent application. Furthermore, the terms "first," "second," and "third" are used for descriptive purposes only and should not be construed as indicating or implying relative importance.

[0036] In this patent application, unless otherwise specified, the term "connection" includes both contacting connections and non-contacting connections, which is determined based on actual usage.

[0037] In a specific embodiment of the present invention, a device for spraying medicine into the nasal olfactory mucosa is provided, as shown in Figures 1 to 5, comprising: a spray head and a device for providing a medicine source, the spray head comprising a nozzle 1, the nozzle being an integrally formed hollow type, and having a channel for passing an external medicine source and / or a channel for arranging an atomizing device; the atomizing device is a water core and a water pipe, a nozzle hole is provided at the center of the top of the nozzle, a cyclone groove is provided on the inner wall of the top of the nozzle, the cyclone groove has three rotating blades evenly distributed along the circumference (not shown in the figure), the center of the cyclone groove is concentric with the nozzle hole, a water core 13 and a water pipe 15 are fixedly mounted in sequence on one end of the nozzle near the nozzle hole, the water core, the water pipe, the cyclone groove and the nozzle hole forming an internally connected medicine liquid channel; a closed arch structure 11 is provided at one end of the outer side of the nozzle, and its arch plane 14 forms a certain angle A with the central axis of the nozzle; a horizontal surface 12 is provided at the bottom end of the nozzle that is tilted toward the nozzle hole, and the horizontal surface 12 forms a certain angle B with the central axis of the nozzle.

[0038] The device for providing a drug source is an injector assembly 2, which includes an injector barrel 21 and a push rod 23. The injector assembly 2 is detachably arranged in the nozzle, and the tail end of the push rod 23 extends out of the tail end of the injector barrel 21.

[0039] In another embodiment of the present invention, the range of A between the bow structure and the central axis of the nozzle is between 35° and 55°, for example, it can be 35°, 40°, 45°, 50° or 55°; and / or, the range of angle B is between 40° and 60°, for example, it can be 40°, 45°, 50°, 55° or 60°.

[0040] In another embodiment of the present invention, a limiting structure 16 is provided at the proximal end of the nozzle, and the length from the nozzle hole to the limiting structure 16 is 20 mm to 30 mm, more preferably 22 mm to 28 mm, further preferably 24 mm to 26 mm; most preferably, 25 mm.

[0041] In another embodiment of the present invention, the water core 13 is integrally formed and is divided into a water core front end 131 and a water core rear end 132. The diameter of the water core rear end 132 is larger than the diameter of the water core front end 131. The water core rear end 132 is provided with one or more water grooves 133 for the passage of liquid medicine, and the water grooves 133 are concave.

[0042] In another embodiment of the present invention, the front end 131 of the water core is a uniform cylindrical shape, the end surface of the front end of the water core is circular, and forms a vortex chamber with the cyclone groove.

[0043] In another specific embodiment of the present invention, the connection between the nozzle and the rear end 132 of the water core is an interference connection, a snap connection or a threaded connection, and more preferably, an interference connection.

[0044] In another specific embodiment of the present invention, the nozzle is integrally formed of plastic material.

[0045] In another specific embodiment of the present invention, the head end of the push rod 23 also has a butyl rubber plug to increase the sealing performance.

[0046] In another specific embodiment of the present invention, the tail end of the push rod 23 is detachably provided with a quantitative clamp, which is used to remove the air in the cavity and fill the medicine liquid and to quantitatively administer the medicine to the nasal olfactory area; the quantitative clamp can adopt a conventional quantitative clamp structure in the field, and is not limited here, with the purpose of being able to achieve quantitative control.

[0047] In another specific embodiment of the present invention, the inner diameter of the liquid suction port at the head end of the syringe assembly 2 is larger than the inner diameter of the water pipe 15 .

[0048] The method of using the utility model to spray liquid medicine into the olfactory area of ​​the nasal cavity is as follows, as shown in Figures 1 to 5:

[0049] 1) Absorbing the liquid medicine: Pick up the liquid pipette head assembly 4, install the liquid pipette head assembly 4 on the head of the syringe assembly 2, remove the liquid pipette head protective cap 41, and absorb the liquid medicine from the medicine bottle.

[0050] 2) Install the injector assembly 2 into the spray head: Use the liquid suction head protective cap 41 to remove the liquid suction head 42 from the injector head, hold the injector barrel, and install the injector assembly 2 into the spray head.

[0051] 3) Emptying and dosing: Fix the dosing clip to the tail of the push rod, push the push rod 23 until it reaches the dosing clip. At this time, the nasal spray device has completed dosing and can be used for nasal administration.

[0052] 4) Nasal administration: For active administration, the patient removes the metered-dose clamp, holds the spray tip between their index and middle fingers, and places the bowed flat surface 14 of the bow structure 11 of the spray tip against their upper lip. Insert the spray tip along the nasal septum until the tip of the nose touches the nozzle stop. Stop insertion. Place the thumb against the bottom of the push rod and rapidly push upward until the push rod reaches the stop and can no longer be pushed. This completes a single dose of the spray tip.

[0053] Passive drug delivery: With the patient supine (without a pillow), the operator removes the dosing clamp, holds the spray tip between the index and middle fingers, and places the bowed dosing surface of the spray tip against the patient's upper lip, maintaining the dosing surface level. Insert the spray tip along the patient's nasal septum into the nasal cavity until the nose tip touches the nozzle stop. Stop insertion. Press the bottom of the push rod with your thumb and rapidly push upward until the rod reaches the stop and can no longer be pushed. This completes a single dose of dosing spray.

[0054] Obviously, the above embodiments are merely examples for clarity of explanation and are not intended to limit the implementation methods. Those skilled in the art will appreciate that other variations or modifications can be made based on the above description. It is not necessary and impossible to enumerate all implementation methods here. Obvious variations or modifications derived therefrom remain within the scope of protection of this patent application.

Claims

1. A spray head for spraying medicine to the mucous membrane of the nasal olfactory region, characterized in that: include: The nozzle (1) is an integrally formed hollow type, and is provided with a chamber for passing an external drug source and / or a chamber for arranging an atomization device; The atomizing device is a water core (13) and / or a water pipe (15), a spray hole is arranged at the center of the top of the nozzle, a cyclone groove is arranged on the inner wall of the top of the nozzle, the center of the cyclone groove is concentric with the spray hole, the water core (13) and the water pipe (15) are fixedly installed in sequence at one end of the nozzle near the spray hole, and the water core (13), the water pipe (15), the cyclone groove and the spray hole form an internally connected liquid medicine channel; A closed bow-shaped structure (11) is provided at one end of the outer side of the nozzle (1), and the bow-shaped plane (14) of the bow-shaped structure (11) forms a certain angle A with the central axis of the nozzle; a horizontal plane (12) tilted toward the spray hole is provided at the bottom end of the nozzle, and the horizontal plane (12) forms a certain angle B with the central axis of the nozzle.

2. The spray head for spraying medicine to the nasal olfactory mucosa according to claim 1, characterized in that: The angle A ranges from 35° to 55°; And / or, the angle B ranges from 40° to 60°.

3. The spray head for spraying medicine to the nasal olfactory mucosa according to claim 2, characterized in that: The angle A is selected from 35°, 40°, 45°, 50° or 55°; And / or, the angle B is selected from 40°, 45°, 50°, 55° or 60°.

4. The spray head for spraying medicine to the nasal olfactory mucosa according to claim 3, characterized in that: A limiting structure (16) is also provided on the outside of the nozzle (1), and the distance between the limiting structure (16) and the nozzle hole is 2 to 3 cm.

5. The spray head for spraying medicine to the nasal olfactory mucosa according to claim 4, characterized in that: The distance between the limiting structure (16) and the spray hole is 2.5 cm.

6. The spray head for spraying medicine to the nasal olfactory mucosa according to claim 5, characterized in that: The water core (13) is integrally formed and is divided into a water core front end (131) and a water core rear end (132). The diameter of the water core rear end (132) is larger than the diameter of the water core front end (131). The water core rear end (132) is provided with one or more water grooves (133) for the liquid medicine to pass through. The water grooves (133) are concave. The water core rear end (132) is fixedly connected to the side wall of the nozzle by interference fit.

7. The spray head for spraying medicine to the nasal olfactory mucosa according to claim 6, characterized in that: The water pipe (15) is hollow, the side wall of the water pipe (15) is fixedly connected to the side wall of the nozzle by interference fit, and the upper end of the water pipe (15) is connected to the lower end of the water core (13); And / or, the cyclone groove has three rotating blades, which are evenly distributed along the circumferential direction.

8. The spray head for spraying medicine to the nasal olfactory mucosa according to claim 7, characterized in that: The nozzle (1) is integrally formed using plastic material.

9. A device for spraying medicine to the mucous membrane of the nasal olfactory region, comprising the spray head according to any one of claims 1 to 8, characterized in that: Also included is a device for providing a drug source.

10. The device for spraying medicine to the nasal olfactory mucosa according to claim 9, characterized in that: The device for spraying medicine onto the mucous membrane of the nasal olfactory region is made of PP material.

11. The device for spraying medicine to the nasal olfactory mucosa according to claim 9, characterized in that: The device for providing a drug source is a pusher assembly (2), which comprises a pusher barrel (21) and a push rod (23). The pusher assembly (2) is detachably arranged in the spray head (1).

12. The device for spraying medicine to the nasal olfactory mucosa according to claim 11, characterized in that: A butyl rubber plug (22) is also provided at the head end of the push rod (23); and / or, the rear end of the push rod (23) extends out of the rear end of the injector barrel (21); and / or, the diameter of the head end of the injector assembly (2) is larger than the inner diameter of the water pipe (15); And / or, a detachable quantitative clamp is further provided at the rear end of the push rod (23).

13. The device for spraying medicine to the nasal olfactory mucosa according to claim 12, characterized in that: The quantitative volume of the quantitative clamp is 0.05mL or 0.1mL.

Citation Information

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