WO2025113132A1 - Spray head for spraying drug to nasal olfactory region mucosa and apparatus therefor - Google Patents

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.

Description

A spray head and device for spraying medicine to the mucous membrane of nasal olfactory area Technical Field

   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

The blood-brain barrier (BBB) is the main bottleneck for drugs to play a therapeutic role in central nervous system diseases. Due to the existence of the blood-brain barrier, existing routes of administration such as oral, intravenous, intramuscular, and subcutaneous administration cannot effectively deliver drugs to the central nervous system (CNS). Since drugs cannot effectively cross the blood-brain barrier, they cannot play a therapeutic role in brain diseases. In addition, as the dosage of drugs increases, systemic side effects also increase.

Drug administration through the nasal mucosa has been considered a way of drug administration that can be quickly and efficiently absorbed. The olfactory mucosa is located at the top of both sides of the nose, with an area of about 5~ ^10cm2 . The mucus layer of the olfactory mucosa is thick and is not affected by the respiratory airflow. Once the drug molecules reach the olfactory mucosa, they are slowly cleared due to the lack of mucus movement. The olfactory epithelium is composed of supporting cells, basal cells and olfactory cells. Olfactory cells are a type of bipolar neuron, whose base extends a slender axon through the basement membrane and forms an unmyelinated nerve fiber bundle in the lamina propria - the olfactory filament, which passes through the cribriform plate of the ethmoid bone and enters the olfactory bulb of the central nervous system. It is precisely because of the existence of the olfactory mucosa that the nasal route of drug administration has a unique brain targeting effect.

Existing nasal drug delivery devices do not have an accurate positioning mechanism. Medical staff or patients believe that drug delivery is 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 it is difficult to play a targeted role in the brain. Due to the irregular operations of different drug delivery personnel, the parallelism of drug efficacy is poor.

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 of Impel, but this drug delivery device adopts the method of adding propellants to enable the drugs 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 air pressure 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 multiple doses of repeated administration.

For some first aid, anesthetic drugs, etc., a single spray will be 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.

At present, for the drug delivery device that delivers a single spray to the upper nasal passage, there is a single spray from Aptar, which uses the method disclosed in CN112512698 A. After puncturing the piston with a steel needle, the drug is injected with a pusher. This method requires the use of a steel needle structure, which is not very convenient for use, and the deposition rate of the drug in the olfactory area can only reach about 5% to 10%. Another nasal sprayer is the single-dose sprayer from Nafi Pharmaceuticals, which uses the method disclosed in CN202320634030.2. When administering the drug, slowly rotate the spray head until the large plane of the drug reference horizontal plane bracket is in a horizontal state, then stop rotating, maintain this water surface angle, and slowly insert the spray head along the nasal septum side of the person being administered for administration. This single-dose sprayer solves the problem of parallelism of drug administration to a certain extent; however, this drug administration technology requires an additional drug administration reference bracket, and is only suitable for passive drug administration scenarios, not active drug administration scenarios, and when administering the drug, the reference bracket needs to be operated by the eye of the drug administerer, and there is a human deviation. For different patients and different medication providers, the medication angle of the sprayer must be consistent to ensure the parallelism of the medication efficacy. Therefore, how to provide a spray head and device that sprays drugs to the nasal olfactory mucosa with good atomization effect, high olfactory area deposition rate and good medication parallelism has become an urgent problem to be solved.

Utility Model Content

In view of this, the utility model provides a spray head for spraying medicine to the mucous membrane of the nasal olfactory region, comprising:

The nozzle is an integrally formed hollow type, and is provided with a chamber for the passage of an external drug source and/or a chamber for setting an atomization device;

The atomization equipment is a water core and/or a water pipe. A spray hole is arranged at the center position 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 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.

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 spray 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.

Preferably, the range of angle A 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°.

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

Preferably, the water core is integrally formed and is divided into a front end of the water core 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. One or more water grooves are provided at the rear end of the water core 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.

Preferably, the front end 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.

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.

Preferably, the cyclone groove has three rotating blades which are evenly distributed along the circumferential direction.

Preferably, the nozzle is integrally formed of plastic material.

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.

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

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

Preferably, a butyl rubber plug is also provided at the head end of the push rod.

Preferably, the rear end of the push rod extends out of the rear end of the injector barrel.

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

Preferably, a detachable quantitative clamp is also provided at the rear 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.

Compared with the prior art, the utility model has the following beneficial effects:

This new device for spraying drugs to the mucous membrane of the nasal olfactory area is used, and a straight liquid medicine acceleration channel is set to speed up the flow of the liquid medicine. After flowing through the cyclone slot, it forms a divergent mist at a specific angle, so that the liquid medicine is concentrated and scattered in the nasal olfactory area at a certain angle, which is easier for the mucous membrane of the nasal olfactory area to absorb; it can eliminate the non-parallelism during drug administration. Whether the patient actively administers the drug or the medical staff passively administers the drug, the arched drug administration fitting surface is against the patient's upper lip for drug administration, and the angle of each insertion is consistent to ensure the parallelism of drug administration.

BRIEF DESCRIPTION OF THE DRAWINGS

In order to more clearly illustrate the embodiments of the utility model or the technical solutions in the prior art, the drawings required for use in the embodiments will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the utility model. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying creative work.

FIG1 is a structural diagram of a spray head device provided by the utility model;

FIG2 is a schematic structural diagram of an injection device assembly provided by the present invention;

FIG3 is a structural diagram of a device for spraying medicine to the nasal olfactory mucosa provided by the present invention;

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

FIG. 5 is a schematic structural diagram of the water core provided by the present utility model.

DETAILED DESCRIPTION

   The determination method of this patent application will be described in further detail below in conjunction with specific examples. It should be understood that the following examples are only exemplary descriptions 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 included in the scope that the present invention is intended to protect.

In the description of this patent application, it should be noted that the terms "center", "upper", "lower", "left", "right", "vertical", "horizontal", "inner", "outer", etc., indicating the orientation or positional relationship, are based on the orientation or positional relationship shown in the drawings, and are only for the convenience of describing this patent application and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as a limitation on this patent application. In addition, the terms "first", "second", and "third" are only used for descriptive purposes and cannot be understood as indicating or implying relative importance.

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

In a specific embodiment of the utility model, a device for spraying medicine to the mucous membrane of the nasal olfactory region 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 is an integrally formed hollow type, and a channel for an external medicine source to pass through and/or a channel for setting an atomization device is provided inside; the atomization device is a water core and 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 cyclone groove has three rotating blades, which are evenly distributed along the circumferential direction (not shown in the figure), 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, the water core, the water pipe and the cyclone groove and the spray hole form an internally connected medicine liquid channel; a closed bow-shaped structure 11 is provided at one end of the outer side of the nozzle, and its bow-shaped plane 14 forms a certain angle A with the central axis of the nozzle; the bottom end of the nozzle is provided with a horizontal plane 12 tilted toward the spray hole, and the horizontal plane 12 forms a certain angle B with the central axis of the nozzle.

The device for providing a drug source is a pusher assembly 2, which includes a pusher barrel 21 and a push rod 23. The pusher assembly 2 is detachably arranged in the nozzle, and the rear end of the push rod 23 extends out of the rear end of the pusher barrel 21.

In another embodiment of the utility model, 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°.

In another embodiment of the utility model, a limiting structure 16 is configured at the proximal end of the nozzle, and the length from the nozzle hole to the limiting structure 16 is 20mm~30mm, more preferably, 22mm~28mm, further preferably, 24mm~26mm; most preferably, 25mm.

In another embodiment of the present utility model, 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.

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.

In another specific embodiment of the present utility model, 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.

In another specific implementation manner of the present utility model, the nozzle is integrally formed of plastic material.

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.

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 from the cavity and fill it with liquid medicine 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, so as to achieve the purpose of quantitative determination.

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

The operation and use method of the utility model for spraying liquid medicine into the olfactory area of the nasal cavity is as follows, as shown in Figures 1 to 5:

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

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

3) Emptying and dosing: The dosing clip is fixed to the tail of the push rod, and the push rod 23 is pushed until the push rod 23 reaches the dosing clip. At this time, the nasal spray device has completed dosing and can be used for nasal administration.

4) Nasal administration: When actively administering, the patient takes out the quantitative clamp by himself, clamps the nozzle with the index finger and the middle finger, presses the arch plane 14 of the nozzle arch structure 11 against the upper lip, and inserts it into the nasal cavity along the nasal septum until the nose tip touches the nozzle limit position, then stops inserting. Press the bottom end of the push rod with the thumb, and quickly push upward until the push rod reaches the limit position and can no longer be pushed, at which time a quantitative spray administration is completed.

Passive drug administration: The patient lies on his back (without a pillow on the head), the operator takes out the quantitative clamp, clamps the nozzle with the index and middle fingers, presses the bow-shaped drug administration fitting surface of the nozzle against the patient's upper lip, and keeps the drug administration level plane horizontal, inserts the nozzle into the nasal cavity along the patient's nasal septum until the nose tip touches the nozzle limit position, then stop inserting. Use the thumb to press the bottom of the push rod, and quickly push upward until the push rod reaches the limit and can no longer be pushed, at which point a quantitative spray is completed.

Obviously, the above embodiments are merely examples for the purpose of clear explanation, and are not intended to limit the implementation methods. For those skilled in the art, other different forms of changes or modifications can be made based on the above description. It is not necessary and impossible to list all the implementation methods here. The obvious changes or modifications derived from these are still within the scope of protection of this patent application.

Claims (13)

A spray head for spraying medicine to the mucous membrane of the nasal olfactory region, characterized by comprising: 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. The spray head for spraying medicine to the nasal olfactory mucosa according to claim 1 is characterized in that: The angle A ranges from 35° to 55°; And/or, the angle B ranges from 40° to 60°. The spray head for spraying medicine to the nasal olfactory mucosa according to claim 2 is 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°. The spray head for spraying medicine to the nasal olfactory mucosa according to claim 3 is 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. The spray head for spraying medicine to the nasal olfactory mucosa according to claim 4 is characterized in that: The distance between the limiting structure (16) and the spray hole is 2.5 cm. The spray head for spraying medicine to the nasal olfactory mucosa according to claim 5 is 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. The spray head for spraying medicine to the nasal olfactory mucosa according to claim 6 is 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. The spray head for spraying medicine to the nasal olfactory mucosa according to claim 7 is characterized in that: The nozzle (1) is integrally formed using plastic material. 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 it also includes a device for providing a medicine source. The device for spraying medicine into the nasal olfactory mucosa according to claim 9 is characterized in that the device for spraying medicine into the nasal olfactory mucosa is made of PP material. The device for spraying medicine into the nasal olfactory mucosa according to claim 9 is characterized in that the device for providing a medicine source is an injector assembly (2), the injector assembly comprises an injector barrel (21) and a push rod (23), and the injector assembly (2) is detachably arranged in the spray head (1). The device for spraying medicine into the nasal olfactory mucosa according to claim 11 is 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). The device for spraying medicine into the nasal olfactory mucosa according to claim 12 is characterized in that the volume of the quantitative clamp is 0.05mL or 0.1mL.