Nasal dry powder inhalation administration device for children

Abstract

The invention relates to the technical field of nasal preparation administration devices, in particular to a nasal dry powder inhalation administration device for children, which comprises a shell, an extrusion sealing mechanism, an auxiliary administration mechanism and a dose dividing mechanism. Wherein the dose dividing mechanism can realize accurate dose dividing and quantitative control of medicine powder according to physiological characteristics and medication requirements of children of different age groups; the auxiliary drug delivery mechanism is connected to the drug outlet end of the drug delivery pipe, the drug delivery path can be optimized according to the structural characteristics of the nasal cavity of a child, drugs are effectively guided to be deposited in the absorption area of the nasal cavity, and waste of the drugs in non-absorption areas such as the nasal vestibule is reduced; the extrusion sealing mechanism can stably spray out medicine powder in the shell through the medicine feeding pipe, and the medicine powder cooperates with the auxiliary medicine feeding mechanism, so that the delivery efficiency of the medicine in the nasal cavity is improved.

Description

Technical Field

[0001] This invention relates to the field of nasal formulation delivery devices, and more specifically, to a pediatric nasal powder inhaler that enables precise dosage dispensing. Background Technology

[0002] The nasal cavity, as a crucial route of drug delivery, plays a vital role in disease treatment due to its rich vascular distribution, strong molecular permeability, ability to bypass gastric degradation and first-pass metabolism in the liver, and minimal influence from proteolytic enzymes and pH. It is suitable for delivering various types of drugs. For a long time, nasal administration has primarily been used for the local delivery of vasoconstrictors or anti-inflammatory drugs to treat nasal congestion, nasal infections, and nasal allergies. In recent years, its application has expanded to systemic drug delivery, vaccination, and brain delivery. Nasal powder inhalers (hereinafter referred to as "nasal powder"), as a solid nasal preparation made from drugs and suitable excipients and sprayed into the nasal cavity through an appropriate delivery device, have shown significant advantages in the treatment of pediatric diseases. However, nasal powders are usually drug-device combination products. Among the seven drugs currently on the market, even glucagon nasal powder used for severe hypoglycemia in diabetic patients aged 4 years and older, has the same dosage as for adults. Significant differences exist between the physiological characteristics of children and adults, and the developmental stages of children at different ages vary, leading to significant differences in drug absorption and metabolism. Specifically, regarding nasal structure, children have relatively large inferior turbinates, narrow airways, and incompletely developed and highly permeable nasal mucosa, which leads to faster drug absorption and increases the risk of medication use. Therefore, nasal powder requires individualized dosage assessment and administration based on children's age differences, but currently there is no dedicated dispensing device for nasal powder in children.

[0003] Currently, publicly available nasal powder delivery devices can be categorized into three types based on their dispensing method: reusable devices (containing a single-use, pre-filled capsule), single-dose devices, and multi-dose devices. While reusable devices offer relatively accurate and flexible dosage, damaged capsule shells can detach and obstruct the airway during capsule puncture, and emptying the powder from the capsule is challenging. Single-dose devices overcome some of the shortcomings of reusable devices by pre-filling the powder during production, but require specific powder filling production lines, leading to higher production costs, and the device's sealing directly affects powder quality. Multi-dose devices offer advantages such as multiple doses, ease of use, improved patient compliance, lower production costs, and reduced financial burden on patients. Due to their high powder content and adjustable dosage, they should be suitable for dose distribution in children of different ages, yet no such products have been marketed to date. Furthermore, existing multi-dose nasal powder devices suffer from poor dose delivery uniformity, posing safety risks to clinical use. Furthermore, considering the unique structure of children's nasal cavities and issues with medication adherence, existing drug delivery devices do not include auxiliary positioning mechanisms suitable for nasal drug delivery in children. This leads to the easy deposition of drugs in non-absorption areas such as the nasal vestibule, affecting the therapeutic effect.

[0004] Therefore, developing a nasal powder delivery device that can meet the age-specific individualized drug delivery needs of children and improve the accuracy of dose delivery and drug deposition efficiency is a technical problem that urgently needs to be solved in this field. Summary of the Invention

[0005] The purpose of this invention is to address the problems existing in current nasal powder inhaler technology, such as the lack of a dedicated nasal powder inhaler for children, the difficulty in flexibly dispensing multi-dose devices, and the absence of an auxiliary positioning mechanism suitable for nasal administration in children. This invention provides a nasal powder inhaler for children that, through a dispensing mechanism tailored to the physiological characteristics and medication needs of children of different ages, achieves precise dispensing and quantitative control of the powder. Furthermore, combined with an auxiliary dispensing mechanism adapted to the nasal structure of children, it improves the efficiency of nasal powder administration in children.

[0006] To achieve the above objectives, the present invention provides a nasal powder inhaler for children, comprising a housing, a compression sealing mechanism, an auxiliary drug delivery mechanism, and a dispensing mechanism. The housing has a hollow structure for accommodating a drug delivery tube, an air inlet tube, and drug powder. The compression sealing mechanism is installed at the top of the housing through the drug delivery tube and is used to spray the drug powder inside the housing out through the drug delivery tube. The auxiliary drug delivery mechanism is connected to the drug outlet end of the drug delivery tube. The dispensing mechanism is located at the bottom of the housing for achieving precise dispensing and quantitative control of the drug powder.

[0007] As a further description of the above technical solution: a dosing chamber is provided at the bottom of the dosing tube, and a drug inlet hole is provided circumferentially on the side wall of the dosing chamber. The dosing chamber is connected to the air inlet tube through the air inlet hole.

[0008] As a further description of the above technical solution: the dispensing mechanism includes a rotary adjustment component and a quantitative slider. The quantitative slider is installed inside the dosing chamber. The rotary adjustment component is used to drive the quantitative slider to move axially inside the dosing chamber. A locking component is provided on the outside of the rotary adjustment component.

[0009] Preferably, the rotary adjustment assembly includes a rotating disk, on which a threaded rod is threadedly connected to a quantitative slider, and the quantitative slider has a threaded groove inside that is adapted to the threaded rod;

[0010] Preferably, the locking assembly includes a locking slider, the upper end of which is connected to the housing via a locking spring, and the lower end of which is provided with a plug rod. The rotation adjustment assembly has a locking hole adapted to the plug rod.

[0011] As a further description of the above technical solution: the outer side of the rotating disk is marked with age or age group, which is used to intuitively set the required dosage.

[0012] As a further description of the above technical solution: the dose distribution mechanism also includes a cylindrical dose adjustment component with a preset scale fracture structure. The outer surface of the cylindrical dose adjustment component is provided with a plurality of dose scale lines with mechanical weakening structure along the axial direction. A locking block is provided at the bottom of the cylindrical dose adjustment component, and a slot adapted to the locking block is opened at the bottom of the dose chamber.

[0013] As a further description of the above technical solution: the auxiliary drug delivery mechanism is ergonomically designed and includes at least one of a basic nasal inlet, a nasal contour-assisted positioning nasal inlet, and a supine drug delivery auxiliary nasal inlet.

[0014] Preferably, the basic nasal inlet has a shape including a frustum, an ellipsoid, and a pear shape;

[0015] Preferably, the nasal contour assist positioning nasal inserter includes a nasal assist positioning device, a dual-channel switching guide rail, and a nasal positioning device connecting seat;

[0016] Preferably, the supine nasal administration aid is provided with a supine administration guiding structure, including a flexible nasal inlet, a supine administration bend, and an administration device connector.

[0017] As a further description of the above technical solution: the reference positioning surface of the nasal auxiliary locator forms a certain angle with the horizontal plane, so that the drug delivery channel outlet faces the nasal cavity. The nasal auxiliary locator is connected to the slider assembly of the dual-channel switching guide rail. The bottom of the nasal auxiliary locator is provided with two symmetrical guide pins, which slide and cooperate with the waist-shaped groove on the dual-channel switching guide rail to realize the function of switching the drug delivery channel.

[0018] As a further description of the above technical solution: the nasal auxiliary locator is provided with a microporous structure to ensure the air permeability of the device.

[0019] As a further description of the above technical solution: the auxiliary drug delivery mechanism is made of flexible medical polymer material, and the surface of the auxiliary drug delivery mechanism adopts a rounded corner transition design.

[0020] As a further description of the above technical solution: the inner surface of the auxiliary drug delivery mechanism, the compression sealing mechanism and the drug delivery tube is at least one of a smooth cylindrical structure or a regular undulating structure. The regular undulating structure can guide the gas to cause disturbance when the airflow passes through, forming local turbulence.

[0021] As a further description of the above technical solution: the compression sealing mechanism includes a sealing shell and a pressing handle. The sealing shell passes through the drug delivery tube and is threadedly connected to the housing. The pressing handle is installed on the upper part of the sealing shell by a return spring.

[0022] The above technical solution has the following advantages or beneficial effects:

[0023] This invention utilizes a dispensing mechanism to precisely dispense and quantify the powder according to the physiological characteristics and medication needs of children of different ages, avoiding efficacy deviations caused by inaccurate drug dosage. The auxiliary drug delivery mechanism, connected to the dispensing end of the delivery tube, can optimize the drug delivery path based on the structural characteristics of children's nasal cavities, effectively guiding the drug to deposit in the nasal absorption area and reducing drug waste in non-absorption areas such as the nasal vestibule. The squeezing and sealing mechanism can stably spray the powder inside the shell through the delivery tube, working in synergy with the auxiliary drug delivery mechanism to improve the delivery efficiency of the drug in the nasal cavity. Attached Figure Description

[0024] Figure 1 This is a schematic diagram of the structure of a pediatric nasal powder inhaler delivery device according to one embodiment of the present invention;

[0025] Figure 2 This is a cross-sectional view of a pediatric nasal powder inhaler delivery device according to one embodiment of the present invention;

[0026] Figure 3 for Figure 1 A schematic diagram of the mid-dose dispensing mechanism;

[0027] Figure 4 for Figure 2 A partial structural diagram of the compression sealing mechanism;

[0028] Figure 5 for Figure 3 A schematic diagram of the bottom of the central rotating disk;

[0029] Figure 6 This is a schematic diagram of the dosing mechanism in another embodiment of the present invention;

[0030] Figure 7 This is a schematic diagram of the auxiliary drug delivery mechanism in another embodiment of the present invention;

[0031] Figure 8 This is a schematic diagram of the auxiliary drug delivery mechanism in another embodiment of the present invention;

[0032] Figure 9 This is a schematic diagram of the auxiliary drug delivery mechanism in another embodiment of the present invention.

[0033] Legend:

[0034] 1. Shell; 2. Drug delivery tube; 3. Compression sealing mechanism; 4. Auxiliary drug delivery mechanism; 5. Dosage dispensing mechanism; 6. Powder gripper; 7. Powder gripper trigger slide bar; 8. Slide groove; 9. Push plate; 201. Dosage chamber; 202. Drug inlet; 203. Slot; 31. Sealing shell; 32. Press handle; 33. Return spring; 34. Air inlet tube; 341. Air inlet; 41. Basic nasal inlet; 42. Nasal contour-assisted positioning nasal inlet; 43. Supine drug delivery auxiliary nasal inlet; 411. Frustum-shaped nasal inlet; 412. Ellipsoidal nasal inlet; 413. Pear-shaped nasal inlet. 421. Nasal inlet; 422. Nasal auxiliary locator; 423. Dual-channel switching guide rail; 424. Nasal locator connector; 435. Flexible nasal inlet; 436. Horizontal drug delivery bend; 437. Drug delivery device connector; 51. Rotary adjustment assembly; 52. Quantitative slider; 53. Locking assembly; 54. Cylindrical dose adjustment component; 55. Dose scale; 56. Locking block; 517. Rotating disk; 518. Threaded rod; 519. Marker; 520. Threaded groove; 531. Locking slider; 532. Locking spring; 533. Insert rod; 534. Locking socket. Detailed Implementation

[0035] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0036] In the description of this invention, it should be noted that the terms "upper", "lower", "horizontal", etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are only for the convenience of describing this invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on this invention.

[0037] In the description of this invention, it should also be noted that, unless otherwise explicitly specified and limited, the terms "set up," "connect," and "connection" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral connection; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium, or a connection within two components. Those skilled in the art can understand the specific meaning of the above terms in this invention according to the specific circumstances.

[0038] Example 1:

[0039] like Figure 1-4 As shown, the present invention provides a nasal powder inhaler for children, comprising a housing 1, a compression sealing mechanism 3, an auxiliary drug delivery mechanism 4, and a dispensing mechanism 5. The housing 1 has a hollow structure for accommodating the drug delivery tube 2, the air inlet tube 34, and the powder. The compression sealing mechanism 3 is installed at the top of the housing 1 through the drug delivery tube 2 and is used to spray the powder inside the housing 1 out through the drug delivery tube 2. The auxiliary drug delivery mechanism 4 is connected to the drug outlet end of the drug delivery tube 2. The dispensing mechanism 5 is located at the bottom of the housing 1 and is used to achieve precise dispensing and quantitative control of the powder.

[0040] In the technical solution of this invention, the dispensing mechanism 5 is set at the bottom of the shell 1, which can realize precise dispensing and quantitative control of the powder according to the physiological characteristics and medication needs of children of different ages, avoiding the efficacy deviation caused by inaccurate drug dosage; the auxiliary drug delivery mechanism 4 is connected to the drug outlet end of the drug delivery tube 2, which can optimize the drug delivery path according to the nasal cavity structure characteristics of children, effectively guide the drug to be deposited in the nasal absorption area, and reduce the waste of drug in non-absorption areas such as the nasal vestibule; the squeezing and sealing mechanism 3 can stably spray the powder inside the shell 1 through the drug delivery tube 2, and work together with the auxiliary drug delivery mechanism 4 to improve the delivery efficiency of the drug in the nasal cavity.

[0041] Specifically, the hollow shell 1 provides a stable space for the drug delivery tube 2, air inlet tube 34, and drug powder, protecting the internal components from external contamination and ensuring the drug powder is in a relatively sealed environment, laying the foundation for subsequent drug delivery. The compression sealing mechanism 3, installed at the top of the shell 1 through the drug delivery tube 2, is responsible for the core function of spraying the drug powder from inside the shell 1 through the drug delivery tube 2. Its sealing design and operating mechanism ensure the controllability of drug powder release. The auxiliary drug delivery mechanism 4 is connected to the dispensing end of the drug delivery tube 2, optimizing the drug delivery path for children's nasal cavity structure and improving the deposition efficiency of the drug in the nasal absorption area. The dispensing mechanism 5, located at the bottom of the shell 1, focuses on achieving precise dispensing and quantitative control of the drug powder, meeting the individualized dosage needs of children of different ages. These four core components have clear divisions of labor and cooperate with each other, achieving precise delivery from drug powder storage and dosage control to drug dispensing, forming a complete and efficient drug delivery closed loop.

[0042] like Figure 3 As shown, the drug delivery tube 2 has a dosage chamber 201 at its bottom, and a drug inlet hole 202 is circumferentially opened on the side wall of the dosage chamber 201. The dosage dispensing mechanism 5 includes a rotary adjustment component 51 and a quantitative slider 52. The quantitative slider 52 is installed inside the dosage chamber 201. The rotary adjustment component 51 is used to drive the quantitative slider 52 to move axially inside the dosage chamber 201. A locking component 53 is provided on the outside of the rotary adjustment component 51. The rotary adjustment component 51 includes a rotating disk 511. A threaded rod 512 that is threadedly connected to the quantitative slider 52 is provided on the rotating disk 511. A threaded groove 521 that is adapted to the threaded rod 512 is opened inside the quantitative slider 52. The locking component 53 includes a locking slider 531. The upper end of the locking slider 531 is connected to the housing 1 through a locking spring 532. An insertion rod 533 is provided at the lower end of the locking slider 531. A locking insertion hole 534 that is adapted to the insertion rod 533 is opened on the rotary adjustment component 51.

[0043] Specifically, rotating the rotating disk 511 drives the threaded rod 512 to rotate, which in turn moves the metering slider 52. Rotating the rotating disk 511 drives the metering slider 52 to move precisely axially within the dosing chamber 201. This threaded transmission method allows for minute displacement adjustments, precisely controlling the volume of powder that can be contained within the dosing chamber 201, ensuring accurate dosage. Especially for small doses of medication needed by children, this effectively avoids treatment effects or safety risks due to excessive dosage adjustment errors. The circumferentially oriented drug inlet 202 on the side wall of the dosing chamber 201, combined with the axial movement of the metering slider 52, allows for flexible control of the amount of powder entering the dosing chamber 201. When the metering slider 52 moves, the space formed by the drug inlet 202 and the metering slider 52 changes, thereby achieving precise control of the powder dosage. Working in conjunction with the rotating adjustment component 51 and the locking component 53, this constitutes a highly efficient and precise dosing system.

[0044] The design of the locking component 53 further enhances the stability of the dosage. The upper end of the locking slider 531 is connected to the housing 1 via a locking spring 532, and the lower end of the insertion rod 533 is adapted to the locking socket 534 on the rotary adjustment component 51. After the dosage is set, under the elastic force of the locking spring 532, the insertion rod 533 is inserted into the locking socket 534, locking the rotary adjustment component 51. This prevents the dosage from changing due to accidental contact with the rotating disk 511 during administration, ensuring that the dosage is consistent with the set value each time, and providing strong protection for the safety of children's medication.

[0045] Among them, such as Figure 5 As shown, an age ( ) is provided on the outer side of the rotating disk 511. Figure 5 A) or age group ( Figure 5 B) The label 513 is used for intuitively setting the required dosage. By rotating the dial 511 and marking the age or age group on its outer side, parents or healthcare professionals can intuitively and quickly set the required dosage based on the child's specific age or age group, eliminating the need for complex calculations or scale interpretation. This simplifies the operation process and reduces operational difficulty, especially in emergency situations such as when a child is crying or uncooperative, helping users quickly complete dosage setting and improving administration efficiency. The dial 511 is engraved with age or age group dosage markings 513. The external pointer corresponds to the scale, intuitively displaying the currently set dosage. The markings 513 can be in numerical or graphic form to meet the reading habits of users of different ages or cultural backgrounds.

[0046] like Figure 1As shown, the auxiliary drug delivery mechanism 4 includes at least one of the following: a basic nasal inlet 41, a nasal contour-assisted positioning nasal inlet 42, and a supine drug delivery auxiliary nasal inlet 43. The auxiliary drug delivery mechanism 4 can be replaced with the basic nasal inlet 41, the nasal contour-assisted positioning nasal inlet 42, and the supine drug delivery auxiliary nasal inlet 43, etc., according to actual needs, and is suitable for users of different ages, different postures, or different nasal cavity structures.

[0047] Specifically, the auxiliary drug delivery device 4 is made of flexible medical polymer material, possessing excellent elasticity and biocompatibility, effectively reducing the risk of mechanical irritation or damage during drug delivery. The surface of the auxiliary drug delivery device 4 features a rounded corner design. This rounded corner design is not merely a simple morphological adjustment, but rather a precise refinement based on anatomical data of a child's nasal cavity. The rounded corner radius strictly follows the transition curve from the nasal vestibule to the proper nasal cavity. When the device enters the nasal cavity, the rounded edges glide along the natural curvature of the nasal passage, avoiding snagging or cutting forces on the nasal hairs or mucosal folds. Taking into full account the easily wobbly head movements during drug delivery in children, even slight displacement is mitigated by the rounded corner structure, which reduces local irritation by dispersing contact stress, keeping the impact of operational errors within a safe range—reflecting the core logic of ergonomics. Simultaneously, the rounded corner structure reduces the coefficient of friction between the device and the nasal cavity, making insertion and withdrawal smoother. This reduces discomfort for children and lowers the user's operational intensity, achieving a dual optimization of human safety and operational efficiency.

[0048] In order to achieve efficient drug powder dispersion, the inner surfaces of the auxiliary drug delivery mechanism 4, the compression sealing mechanism 3 and the drug delivery tube 2 are provided with regular undulating structures, such as spiral or corrugated protrusions, to create turbulence, increase the intensity of airflow disturbance, thereby breaking up the aggregated drug powder particles, improving atomization uniformity, and forming an aerosol with uniform particle size and high stability.

[0049] like Figure 1 and Figure 2 As shown, the compression sealing mechanism 3 includes a sealing shell 31 and a pressing handle 32. The sealing shell 31 passes through the drug delivery tube 2 and is threadedly connected to the housing 1. The pressing handle 32 is installed on the upper part of the sealing shell 31 by a return spring 33. By pressing the pressing handle 32, airflow can be driven into the dosing chamber 201, and then sprayed out through the drug outlet end of the drug delivery tube 2 and the auxiliary drug delivery mechanism 4 to complete the drug delivery process. After the pressing handle 32 is released, it returns to the initial position by the return spring 33, which is convenient for repeated use.

[0050] Specifically, such as Figure 3 and Figure 4As shown, the bottom of the sealing shell 31 is provided with an air inlet pipe 34 located on one side of the drug delivery tube 2, and the other side of the dosage chamber 201 is provided with an air inlet hole 341 communicating with the air inlet pipe 34. By pressing and actuating the pressing handle 32, the air cavity inside the sealing shell 31 can be compressed, so that the high-pressure airflow is accurately introduced into the dosage chamber 201 through the air inlet pipe 34. The air pressure difference drives the powder system to move quickly along the drug delivery tube 2, and finally sprays it out in a directional manner through the channel of the auxiliary drug delivery mechanism 4, so as to achieve efficient delivery of the drug in the nasal cavity.

[0051] like Figure 2 and Figure 3 As shown, in order to improve the accuracy and efficiency of powder release, a powder gripper 6 is also provided inside the housing 1. The upper end of the powder gripper 6 is rotatably connected to the lower end of the matching slide groove 8. The upper end of the powder gripper 6 is provided with a powder gripper trigger slide 7 and its matching slide groove 8. The upper end of the powder gripper trigger slide 7 is connected to the pressing handle 32. The lower end of the powder gripper 6 is provided with a push plate 9 that is compatible with the drug inlet hole 202, which is used to help push the quantitative powder smoothly through the drug inlet hole 202 into the dosing chamber 201.

[0052] Specifically, the push plate 9 at the lower end of the powder gripper 6 is precisely matched with the inlet hole 202. When the device is adjusted for dosage, the push plate 9 can apply a pushing force to the quantitative powder, ensuring that the preset dose of powder passes completely through the inlet hole 202 into the dosage chamber 201. This effectively avoids the problem of insufficient dosage caused by poor powder flowability, clumping, or adsorption on the inner wall of the housing 1 in traditional devices. Especially for small doses of medication required by children, it can minimize the deviation between the actual dosage and the set dosage. The auxiliary pushing effect of the push plate 9 can significantly reduce the amount of powder residue around the inlet hole 202 and at the bottom of the housing 1. The dosage of pediatric nasal powder is usually very precise, and even a small amount of residue can affect the therapeutic effect. The pusher plate 9 can conform to the contour of the drug inlet 202 for a sweeping push, keeping the residue level extremely low. This not only improves drug utilization but also avoids the interference of residual powder accumulation on device performance after multiple administrations. The powder grabbing lever trigger slide 7 is directly connected to the pressing handle 32, forming a continuous linkage mechanism of "pressing operation - slide transmission - grabbing action - pusher plate delivery". When medical staff or parents press the handle 32, the powder grabbing lever trigger slide 7 moves synchronously along the matching slide groove 8, driving the powder grabbing lever 6 to rotate, so that the pusher plate 9 can accurately complete the drug delivery action. The whole process is synchronized with the powder spraying operation, without additional steps, and ensures a high degree of matching between the drug delivery action and the administration rhythm, reducing human operation error. It is especially suitable for quickly completing drug administration in emergency situations such as when children are crying or uncooperative.

[0053] The present invention designs a multi-level sealing connection structure between various key components. The auxiliary drug delivery mechanism 4, the compression sealing mechanism 3, the housing 1 and the dispensing mechanism 5 are all designed with tight connection, including various forms such as threaded connection, snap locking and ring sealing gasket fitting.

[0054] This embodiment provides a nasal powder inhaler that is compact, easy to operate, has adjustable dosage, and is safe and prevents misoperation. It is especially suitable for children and other people who need to accurately control the dosage of medication.

[0055] Example 2:

[0056] To more clearly illustrate the technical solution of the present invention, in conjunction with Figure 6 The document describes a specific structure and provides an embodiment of a dose-dispensing mechanism based on a preset scale fracture structure.

[0057] The dose distribution mechanism 5 also includes a cylindrical dose adjustment component 54 with a preset scale fracture structure. The outer surface of the cylindrical dose adjustment component 54 is provided with a number of dose scale lines 55 with mechanical weakening structures along the axial direction. A locking block 56 is provided at the bottom of the cylindrical dose adjustment component 54, and a slot 203 adapted to the locking block 56 is opened at the bottom of the dose chamber 201.

[0058] Specifically, a dosage mechanism based on a preset scale fracture structure includes a cylindrical dosage adjustment component 54 made of medical-grade plastic material. Multiple dosage scale lines 55 are axially arranged on its outer surface, each scale line corresponding to a standardized dosage unit. To facilitate accurate fracture without tools, the cylindrical dosage adjustment component has a mechanically weakening structure at each dosage scale line, preferably a V-groove or a semi-circular inner groove, ensuring both ease of fracture and maintaining structural strength and safety.

[0059] In practical use, the cylindrical dose adjuster 54 can be removed from the drug packaging according to the doctor's prescription or specific treatment needs. It can then be manually broken along the inner groove at the corresponding scale position to obtain a cylindrical segment of the desired length corresponding to the required dose. Subsequently, the cylinder is inserted into the slot 203 at the bottom of the dose chamber 201 via a locking block 56 at its bottom for precise positioning and locking. The locking block 56 automatically springs into the slot 203 after insertion, ensuring that the broken cylindrical dose adjuster 54 will not loosen or slip during use, thus effectively guaranteeing dose stability and operational reliability.

[0060] Example 3:

[0061] like Figure 7 As shown, this embodiment discloses a basic nasal inlet, the basic nasal inlet 41 having shapes including frustum, ellipsoid, and pear.

[0062] The 411 frustum-shaped nasal inlet features a tapered, tapered design and is made of medical-grade flexible material. During drug administration, the frustum-shaped nasal inlet achieves passive contact with the nasal vestibule, making it suitable for nasal drug administration in children aged 12 and above with relatively complete nasal passage development.

[0063] Specifically, the tapered, gradually increasing design references the average diameter gradient of the nasal passages in children of this age group, with the diameter slowly increasing from the tip to the base, perfectly matching the physiological curvature from the nasal vestibule to the nasal cavity. This conforming shape allows the nasal inlet to naturally follow the direction of the nasal passage during insertion, avoiding problems such as local jamming or excessive gaps caused by size mismatch, providing a stable foundation for subsequent drug administration. The medical-grade flexible silicone material ensures sufficient structural stability to maintain unobstructed drug delivery, while also allowing for slight deformation upon contact with the nasal mucosa. This deformation characteristic reduces rigid pressure on the nasal mucosa, lowering the risk of mechanical irritation or damage, making it particularly suitable for children over 12 years old whose nasal tissues, although relatively fully developed, are still sensitive.

[0064] The ellipsoidal nasal inlet 412 is designed in the shape of a biomimetic pacifier and is suitable for infants aged 1-3 years who resist medication.

[0065] Specifically, the biomimetic pacifier design aligns with infants' natural familiarity and dependence on pacifiers, reducing their wariness of unfamiliar medical devices through both visual and tactile signals. Infants aged 1-3 are in a sensitive period for objects and have an instinctive tendency to accept pacifier-like items. This design associates medication administration with daily comfort experiences, reducing resistance reactions such as crying and head shaking caused by fear, thus improving medication compliance from a psychological perspective. Made of ultra-soft medical-grade rubber, it is soft and elastic, providing cushioning when in contact with the delicate nasal mucosa of infants and avoiding damage caused by hard friction. Simultaneously, the natural limiting design, with a base diameter larger than the nasal vestibule inlet, prevents excessive insertion without additional manipulation, avoiding stimulation of deep nasal tissues even when infants struggle, thus solving the pain point of difficulty in controlling insertion depth when administering medication to young children.

[0066] The pear-shaped nasal insulator 413 is made of deformable memory silicone, which automatically restores its shape after administration. It is suitable for asymmetrical nasal administration. At the same time, the pear-shaped nasal insulator 413 is equipped with a limiting protrusion to prevent excessive insertion. It is suitable for children aged 3-12 years during the nasal cavity development period.

[0067] Specifically, the deformable memory silicone material possesses a unique "pressure-deformed - self-recovering" characteristic. During insertion into the nasal cavity, it adapts to the shape and pressure of the child's nasal cavity wall, easily navigating narrow, curved, or asymmetrical areas that may exist due to incomplete development, reducing pressure and friction on nasal tissues. After medication administration, it automatically returns to its initial pear-shaped structure within a short time, facilitating easy removal and avoiding secondary irritation during retrieval caused by materials that are too hard or lack elasticity. This is especially suitable for children aged 3-12 years, whose nasal structures are in dynamic development and exhibit significant individual differences. The limiting protrusions act as a barrier when the nasal insulator is inserted to the appropriate depth, preventing damage to sensitive deep nasal tissues due to improper operation or sudden movement by the child.

[0068] Example 4:

[0069] like Figure 8 As shown, this embodiment discloses a nasal contour-assisted positioning device for children. The nasal contour-assisted positioning device 42 includes a nasal auxiliary locator 421, a dual-channel switching guide rail 422, and a nasal locator connector 423. The nasal locator connector 423 is installed at the drug dispensing end of the drug delivery tube 2. The dual-channel switching guide rail 422 is connected to the nasal locator connector 423. The nasal auxiliary locator 421, as the core positioning component, is connected to the dual-channel switching guide rail 422 to jointly realize the precise positioning of the child's nasal cavity and the function of switching the drug delivery channel.

[0070] The nasal locator 421 adopts a design that mimics the contour of the human nose, with a symmetrical arc-shaped structure to fit the physiological curve of the nasal wings in children aged 1-12 years. The contact surface of the nasal locator 431 is equipped with a 0.5mm thick medical-grade silicone layer, which is fixed to a rigid plastic substrate through injection molding, ensuring both structural strength and flexible fit, thus avoiding pressure damage to the child's nasal cavity during drug administration. Furthermore, the nasal locator 431 features a microporous design to ensure the device's breathability. The locator's reference positioning surface forms a certain angle with the horizontal plane, and this angle is matched to the physiological axis of the child's nasal cavity, ensuring that the drug delivery channel outlet is directly aligned with the drug delivery target area on the nasal mucosa, solving the problem of low deposition rate of nasal powder in existing technologies.

[0071] In terms of structural connection, the nasal auxiliary locator 421 is fixed to the slider assembly of the dual-channel switching guide rail 422. Two symmetrical guide pins are provided at the bottom of the locator, which slide in conjunction with the waist-shaped groove on the guide rail to realize the function of switching the drug delivery channel. When the nasal locator connecting seat 423 is moved, the slider assembly moves along the guide rail axis, aligning the drug delivery channel axis with the left and right nasal cavities one by one. This effectively solves the technical limitations of traditional pediatric nasal drug delivery devices, such as low drug delivery efficiency due to positioning deviation, poor child cooperation, and nasal discomfort during operation, significantly improving the convenience and safety of pediatric nasal drug delivery.

[0072] The working process of this embodiment is as follows:

[0073] Assembly: Insert the drug dispensing end of the drug delivery tube 2 into the adapter interface of the nasal positioner connector 423. The O-ring at the interface provides radial sealing to ensure no leakage during the drug powder delivery process, thus completing the rigid connection between the drug delivery device and the nasal auxiliary positioning system.

[0074] Positioning: The silicone end face of the nasal auxiliary positioner 421 is attached to the child's nose, and its biomimetic structure is used to achieve pre-positioning;

[0075] Drug administration: Press handle 32 to spray the powder out through the current channel under air pressure;

[0076] Switching: Move the nasal locator connector 423 to the right. The slider assembly moves to the right along the guide rail. When the locating pin falls into the right locating hole, a feedback sound is emitted, indicating that the channel has been switched to the right nasal cavity. Press the handle 32 repeatedly to complete the administration on the other side.

[0077] Compared with existing technologies, the nasal auxiliary locator in this embodiment combines biomimetic design with a rigid connection structure, which not only ensures the positioning stability when administering medication to children, but also achieves deviation-free channel switching through coordinated work with the switching guide, significantly improving the accuracy of medication administration.

[0078] Example 5:

[0079] like Figure 9 As shown, this embodiment discloses a supine nasal insufflation device for pediatric drug administration. The supine nasal insufflation device 43 includes a flexible nasal insufflation device 431, a supine drug administration curved tube 432, and a drug administration device connector 433. The flexible nasal insufflation device 431 is connected to one end of the supine drug administration curved tube 432, and the drug administration device connector 433 is connected to the other end of the supine drug administration curved tube 432. The drug administration device connector 433 is installed at the drug outlet end of the drug administration tube 2. This system solves technical problems such as positioning deviation, drug residue, and inconvenience of operation when administering drugs through the nasal cavity in a supine position for children through biomimetic structural design and fluid dynamics optimization. It is especially suitable for nasal powder drug administration scenarios for children aged 2-12 years.

[0080] The flexible nasal insulator 431 is the core contact component, injection molded from medical-grade silicone. Its head has a hemispherical arc design, adapted to the physiological size of the nasal vestibule in children. The dispensing port of the flexible nasal insulator 431 is located at a 15° angle on the side of the top, forming an optimal spray angle with the nasal mucosa target area.

[0081] The supine position adapter bend 432 has a curved structure, which can form a natural spatial angle with the axis of the superior nasal meatus. The drug delivery device connector 433, as the only docking component with the main device, has a quick-release buckle structure at the end opposite the supine position adapter bend 432, and an internal positioning groove. The docking surface between the drug delivery device connector 433 and the drug delivery tube 2 has an annular sealing groove with a built-in medical silicone rubber O-ring. When the buckle is fully engaged, the O-ring is compressed, achieving a radial static seal and meeting the airtightness requirements of the powder delivery process.

[0082] The working process of this embodiment is as follows:

[0083] Assembly: The integrated assembly consisting of the flexible nasal inlet 431, the lying position adaptation bend 432 and the drug delivery device connector 433 is connected to the drug delivery tube 2 through the quick-release buckle of the drug delivery device connector 433 until the buckle makes a "click" locking sound. At this time, the positioning boss is fully embedded in the positioning groove of the main body of the device, and the overall assembly is completed.

[0084] Positioning: When administering medication in a supine position, gently insert the flexible nasal inlet 431 into one nostril, ensuring that the medication delivery channel outlet is aligned with the nasal passage area and avoiding excessive insertion;

[0085] Drug administration: Press the handle 32, and the powder enters the guide channel of the horizontal adaptation bend tube 432 under air pressure through the drug administration device connector 433. A stable airflow is formed at the bend, and finally sprayed into the target area through the oblique outlet of the flexible nasal inlet 431. After a single dose is administered, keep the device still for 1-2 seconds and remove it after the residual powder settles.

[0086] This embodiment is designed for children's physiological characteristics, using a supine nasal delivery aid. The device can keep the delivery channel aligned with the target area inside the nasal cavity when the child is supine, overcoming the problem of low delivery efficiency caused by positioning deviation when administering medication in a supine position in traditional delivery devices.

[0087] It should be noted that, in this document, the term "comprising" or any other variation thereof is intended to cover a non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements includes not only those elements but also other elements not expressly listed, or elements inherent to such a process, method, article, or apparatus.

[0088] The preferred embodiments of the present invention disclosed above are merely illustrative of the invention. These preferred embodiments do not exhaustively describe all details, nor do they limit the invention to the specific implementations described. Clearly, many modifications and variations can be made based on the content of this specification. This specification selects and specifically describes these embodiments to better explain the principles and practical applications of the invention, thereby enabling those skilled in the art to better understand and utilize the invention. The invention is limited only by the claims and their full scope and equivalents.

Claims

1. A nasal powder inhaler for children, characterized in that, include: The housing has a hollow structure and is used to house the drug delivery tube, the air inlet tube, and the drug powder; A squeeze sealing mechanism is installed at the top of the housing through the drug delivery tube and is used to spray the drug powder inside the housing out through the drug delivery tube; An auxiliary drug delivery mechanism is connected to the drug outlet end of the drug delivery tube; The dosage dispensing mechanism is located at the bottom of the housing and is used to achieve precise dosage and quantitative control of the powder.

2. The pediatric nasal powder inhaler delivery device according to claim 1, characterized in that, The drug delivery tube has a dosage chamber at the bottom, and a drug inlet hole is provided on the side wall of the dosage chamber. The dosage chamber is connected to the air inlet tube through the air inlet hole.

3. The pediatric nasal powder inhaler delivery device according to claim 2, characterized in that, The dispensing mechanism includes a rotary adjustment component and a quantitative slider. The quantitative slider is installed inside the dosing chamber. The rotary adjustment component is used to drive the quantitative slider to move axially inside the dosing chamber. A locking component is provided on the outside of the rotary adjustment component. Preferably, the rotary adjustment assembly includes a rotating disk, on which a threaded rod is threadedly connected to a quantitative slider, and the quantitative slider has a threaded groove inside that is adapted to the threaded rod; Preferably, the locking assembly includes a locking slider, the upper end of which is connected to the housing via a locking spring, and the lower end of which is provided with a plug rod. The rotation adjustment assembly has a locking hole adapted to the plug rod.

4. The pediatric nasal powder inhaler delivery device according to claim 3, characterized in that, The outer side of the rotating disc is marked with age or age group indicators for intuitive setting of the required dosage.

5. The pediatric nasal powder inhaler delivery device according to claim 2, characterized in that, The dose distribution mechanism also includes a cylindrical dose adjustment component with a preset scale fracture structure. The outer surface of the cylindrical dose adjustment component is provided with a plurality of dose scale lines with mechanical weakening structure along the axial direction. A locking block is provided at the bottom of the cylindrical dose adjustment component, and a locking groove adapted to the locking block is opened at the bottom of the dose chamber.

6. The pediatric nasal powder inhaler delivery device according to any one of claims 1-5, characterized in that, The auxiliary drug delivery mechanism is ergonomically designed and includes at least one of a basic nasal inlet, a nasal contour-assisted positioning nasal inlet, and a supine drug delivery auxiliary nasal inlet. Preferably, the basic nasal inlet has a shape including a frustum, an ellipsoid, and a pear shape; Preferably, the nasal contour assist positioning nasal inserter includes a nasal assist positioning device, a dual-channel switching guide rail, and a nasal positioning device connecting seat; Preferably, the supine nasal administration aid is provided with a supine administration guiding structure, including a flexible nasal inlet, a supine administration bend, and an administration device connector.

7. The pediatric nasal powder inhaler delivery device according to claim 6, characterized in that, The reference positioning surface of the nasal auxiliary locator forms a certain angle with the horizontal plane, so that the drug delivery channel outlet faces the nasal cavity. The nasal auxiliary locator is connected to the slider assembly of the dual-channel switching guide rail. The bottom of the nasal auxiliary locator is provided with two symmetrical guide pins, which slide and cooperate with the waist-shaped groove on the dual-channel switching guide rail to realize the function of switching the drug delivery channel. The nasal auxiliary locator is provided with a microporous structure to ensure the air permeability of the device.

8. The pediatric nasal powder inhaler delivery device according to claim 6, characterized in that, The auxiliary drug delivery mechanism is made of flexible medical polymer material, and the surface of the auxiliary drug delivery mechanism adopts a rounded corner transition design.

9. The pediatric nasal powder inhaler delivery device according to claim 1, characterized in that, The inner surface of the auxiliary drug delivery mechanism, the compression sealing mechanism, and the drug delivery tube is at least one of a smooth cylindrical structure or a regular undulating structure. The regular undulating structure can guide the gas to cause disturbance when the airflow passes through, forming local turbulence.

10. The pediatric nasal powder inhaler delivery device according to claim 1, characterized in that, The compression sealing mechanism includes a sealing shell and a pressing handle. The sealing shell passes through the drug delivery tube and is threadedly connected to the housing. The pressing handle is mounted on the upper part of the sealing shell by a return spring.

Images