Exocrine nasal spray pusher

Abstract

In the field of medical device technology, we provide a pusher for nasal sprays for the exocrine system. [Solution] The device includes a drug solution bottle, a pressing component, an atomizing chamber 5, a microporous screen plate 6, and a nozzle component 7. The atomizing chamber is provided with a flow guide cone and an annular buffer chamber for guiding the drug solution and buffering the flow velocity. The microporous screen plate has uniformly distributed micropores and atomizes the drug solution into droplets with concentrated particle size. The nozzle component includes a throttling ring and an opening for restricting the initial spray velocity of the droplets and for ejecting them at an inclined angle. The coordination of these structures reduces the shear force generated on the exocrine system during the spraying process, improving consistency and dose reproducibility in the administration of exocrine nasal sprays. Conventional nasal spray devices are prone to structural damage during the spraying process for shear-sensitive substances such as exocrine systems, resulting in insufficient consistency and reproducibility of administration.

Description

Technical Field

[0001] This invention belongs to the technical field of medical devices, and particularly relates to a pusher for a nasal spray for exosomes.

Background Art

[0002] The nasal administration of exosomes is a non-invasive route for delivering mesenchymal stem cell-derived exosomes and has potential application value in the treatment research of neurodegenerative diseases such as Parkinson's disease. This method utilizes the rich vascular network of the nasal mucosa and the relatively open blood-brain barrier pathway to promote the delivery of exosome components to the central nervous system and provides a feasible route for evaluating the safety and tolerance in Parkinson's disease patients. In existing nasal spray devices, usually, a push-type spray structure is used to achieve the atomized release of liquid drugs, and its basic composition consists of components such as a drug solution bottle, a push pump, a nozzle, and a tube. By manually pressing down, the internal piston is actuated to spray the drug solution in a mist form.

[0003] However, for bioactive substances sensitive to shear force such as exosomes, in conventional nasal spray devices, the internal flow path design and pressure release mechanism in the spraying process are not precise enough, which may cause damage to the exosome structure and uneven distribution, affecting the consistency of administration and the reliability of experimental data. Therefore, existing nasal spray devices have limitations in that when used for exosome delivery, they are insufficient in controlling the spraying particle size, injection pressure, and repeated accuracy of the dosage, and it is difficult to meet the specific requirements of stable and reproducible administration of exosome nasal sprays in preclinical or clinical research.

Summary of the Invention

Problems to be Solved by the Invention

[0004] This invention provides an exocrine nasal spray pusher for delivering mesenchymal stem cell-derived exocrine substances in Parkinson's disease treatment research. By optimizing the internal flow path structure and pressure release mechanism, the shear force generated in the bioactive substance during the spraying process is reduced, thereby improving consistency and repeatability of the administration of exocrine nasal spray agents. [Means for solving the problem]

[0005] To achieve the above objective, this invention employs the following technical solution:

[0006] An exocrine nasal spray pusher includes a drug solution bottle, a pressing component, an atomizing chamber, a microporous screen plate, and a nozzle component.

[0007] The aforementioned pressing component is connected to a drug solution bottle and is used to generate pressure to drive the drug solution through manual pressing.

[0008] The atomizing chamber is installed inside the chemical solution bottle and includes a flow guide cone and an annular buffer chamber. The flow guide cone is fixed to the center of the bottom surface inside the chemical solution bottle and is used to guide the chemical solution so that it is uniformly distributed along its conical surface. The annular buffer chamber is installed surrounding the flow guide cone and is used to buffer the flow velocity of the chemical solution.

[0009] The aforementioned microporous screen plate is installed inside the atomization chamber and has multiple micropores of uniform diameter, which are used to atomize the liquid chemical into droplets with a concentrated particle size.

[0010] The nozzle component includes a spray tube, an expanding section, and a throttling ring. One end of the spray tube is connected to the atomizing chamber, and the other end extends outside the chemical bottle. The throttling ring is installed on the inner wall of the expanding section. The expanding section is installed at the outlet end of the spray tube, and its inner diameter gradually increases from the inside to the outside, and is used to diffuse the mist droplets and eject them at an inclined angle.

[0011] The pressing component includes a pressing head, a piston rod, and an elastic reset member. The pressing head is located at the top of the drug solution bottle. The piston rod is connected to the pressing head and inserted into the drug solution bottle. Two annular sealing ribs are provided on the outer wall of the piston rod, and a lubrication groove is formed between the two annular sealing ribs. The lubrication groove is filled with lubricant. The elastic reset member is mounted on the outside of the piston rod and is used for resetting after pressing.

[0012] A spiral flow guide groove is provided on the inner wall of the annular buffer chamber, and the spiral flow guide groove extends from the top to the bottom. The microporous screen plate is located above the spiral flow guide groove, and the micropore diameter of the microporous screen plate ranges from 10 μm to 30 μm, with the micropores arranged in a honeycomb pattern.

[0013] The angle between the outlet end face of the widened section and the horizontal plane is 15°. The inner diameter of the diaphragm ring is 0.6 mm. [Effects of the Invention]

[0014] This invention effectively avoids localized high-speed flow by guiding and buffering the liquid chemical through the coordinated action of a flow guide cone and annular buffer chamber. Uniform micropores arranged regularly on a microporous screen plate break the liquid chemical into concentrated droplets under low pressure. The combination of a throttling ring and an expanding section restricts the initial ejection kinetic energy of the droplets, causing them to diffusely eject at a specific angle. The combination of the above core structures systematically reduces the shear stress the liquid chemical experiences throughout the atomization process through three stages: flow path buffering, atomization uniformity, and kinetic energy control. This protects the structural integrity of the exocrine system and improves the consistency of the spray.

[0015] The pressing component employs a piston rod design with a double annular sealing rib and a lubrication groove filled with lubricant. This structure reduces frictional resistance and fluctuations with the inner wall of the drug bottle during the piston's reciprocating motion. Combined with the stable rebound of the elastic reset member, this design ensures smoothness of each pressing stroke and accuracy of the reset. Such smooth mechanical motion is advantageous in maintaining the relative stability of the drive pressure generated with each press, thereby directly contributing to high repeatability of the injection dose and reducing dose variations due to frictional fluctuations during operation.

[0016] The spiral flow guide grooves on the inner wall of the annular buffer chamber induce rotation in the drug solution, further moderating the flow velocity. The precise pore size (10-30 μm) and honeycomb-like regular arrangement of the microporous screen plate structurally ensure uniformity of the droplet generation source. The 15° outlet angle of the widening section and the 0.6 mm inner diameter of the throttling ring work together to regulate the droplet spray trajectory and velocity. Thus, this invention achieves the goal of a concentrated droplet particle size distribution, a gentle spray velocity, and appropriate direction, thereby improving the drug deposition efficiency on the nasal mucosa and further ensuring the stability of atomization performance between different doses. [Brief explanation of the drawing]

[0017] [Figure 1] Figure 1 illustrates the overall structure of this invention. [Figure 2] Figure 2 shows the longitudinal cross-sectional structure of an exocrine nasal spray pusher. [Figure 3] Figure 3 illustrates the partial structure of the atomization chamber and microporous screen plate. [Figure 4] Figure 4 illustrates the partial structure of the nozzle component. [Modes for carrying out the invention]

[0018] The embodiments of the present invention will be described below with reference to the drawings. These embodiments are provided for the purpose of clearly and completely illustrating the present invention and do not limit its scope.

[0019] Refer to Figures 1 to 4. This invention provides an exocortic nasal spray pusher for delivering a mesenchymal stem cell-derived exocortic nasal spray agent in Parkinson's disease treatment research. The overall structure of the exocortic nasal spray pusher includes a drug solution bottle 1, a pressing component, an atomizing chamber 5, a microporous screen plate 6, a nozzle component 7, and a throttling ring 8. Each component is precisely assembled to ensure stable transport and atomization of the drug solution while avoiding damage to the exocortic activity due to high shear forces.

[0020] The drug solution bottle 1 is a hollow cylindrical container with an opening at its top, and its interior is used to contain an exocrine nasal spray. The drug solution bottle 1 is manufactured by injection molding using medical-grade polypropylene material, and its inner surface roughness Ra value is 0.4 μm or less, reducing frictional resistance during the liquid flow process.

[0021] The pressing component includes a pressing head 2, a piston rod 3, and an elastic reset member 4. The pressing head 2 is attached to the top opening of the drug solution bottle 1, and the bottom of the pressing head 2 is fixedly connected to the upper end of the piston rod 3. The lower end of the piston rod 3 is inserted into the inside of the drug solution bottle 1 and slides into contact with the inner wall of the drug solution bottle 1. Two annular sealing ribs are provided on the outer wall of the piston rod 3, located in the middle and lower parts of the piston rod 3, respectively. A lubrication groove is formed between the two annular sealing ribs, and the lubrication groove is filled with medical-grade silicone oil to reduce frictional resistance during the reciprocating motion of the piston rod 3, ensuring smoothness of the pressing operation and consistency of the dosage.

[0022] The elastic reset member 4 is mounted outside the piston rod 3, with one end contacting the bottom of the pressing head 2 and the other end contacting the top edge of the chemical liquid bottle 1. The elastic reset member 4 is a coil spring, wound by a stainless steel wire, and has good elasticity and corrosion resistance. When the pressing head 2 is pushed down, the elastic reset member 4 is compressed to store energy. When the external force is removed, the elastic reset member 4 releases energy to reset the pressing head 2 and the piston rod 3 to their initial positions.

[0023] The pressing component further includes a limit coupler. The limit coupler is fixed to the outside of the top of the chemical liquid bottle 1, and a protrusion is provided on its inner side. A recess is provided at the corresponding position on the outer wall of the pressing head 2. When the pressing head 2 is pushed down to the maximum stroke, the protrusion fits into the recess to limit the further descent of the pressing head 2 and prevent damage to the internal structure and excessive spraying of the chemical liquid due to excessive pressing.

[0024] The atomization chamber 5 is installed inside the chemical liquid bottle 1 and includes a flow guiding cone, an annular buffer chamber, and a microporous screen plate 6. The flow guiding cone is fixed at the center position of the inner bottom surface of the chemical liquid bottle 1, and its conical surface faces upward with a cone angle of 60°. It is used to avoid the liquid concentrating and impacting in a local area by evenly distributing the liquid along the conical surface. The annular buffer chamber is installed surrounding the outer circumference of the flow guiding cone. The height of the annular buffer chamber is 5 mm, and a spiral flow guiding groove is provided on its inner wall. The spiral flow guiding groove extends clockwise from the top to the bottom, with a lead of 2 mm and a groove depth of 0.3 mm. The spiral flow guiding groove allows the liquid to experience rotational buffering before entering the microporous screen plate 6, further reducing the flow rate fluctuation.

[0025] The microporous screen plate 6 has multiple micropores of uniform diameter. The pore diameter ranges from 10 μm to 30 μm, and the micropores are arranged in a honeycomb pattern, with a distance of 50 μm or more between the centers of adjacent micropores. The microporous screen plate 6 is made of polytetrafluoroethylene material and has a thickness of 0.8 mm. The micropores penetrate the upper and lower surfaces of the screen plate, and the axes of the micropores are perpendicular to the plane of the screen plate. Polytetrafluoroethylene material has excellent chemical inertness and biocompatibility, which prevents reaction between the chemical components and the screen plate. At the same time, its low surface energy properties help droplets to easily detach from the screen plate surface.

[0026] The nozzle component 7 includes a spray tube, an expanding section, and a throttling ring 8. The spray tube is a straight tube structure, with one end penetrating and connected to the top of the atomizing chamber 5, and the other end extending to the outside of the drug solution bottle 1. The expanding section is located at the outlet end of the spray tube, and its inner diameter gradually increases from the inside to the outside, forming a trumpet-shaped outlet. The angle between the outlet end face of the expanding section and the horizontal plane is 15°, so that the mist droplets enter the nasal vestibular region at an inclined angle, thereby increasing the efficiency of drug deposition in the nasal mucosa. The throttling ring 8 is located in the center of the inner wall of the expanding section, is made of stainless steel, has an inner diameter of 0.6 mm, and a thickness of 0.5 mm. The throttling ring 8 restricts the initial spray velocity of the gas-liquid mixture, preventing damage to the exocrine structure due to the high shear force caused by high-speed spraying.

[0027] Both the atomizing chamber 5 and the drug solution bottle 1 are manufactured by injection molding using medical-grade polypropylene material, ensuring a smooth and continuous internal flow path without blind spots or abrupt cross-sectional changes, thereby reducing turbulence. The entire device contains no electronic components and completes all processes of drug suction, pressurization, buffering, atomization, and injection through a purely mechanical structure.

[0028] During use, the user holds the drug solution bottle 1 in their hand and points the nozzle component 7 towards the nasal cavity entrance. When the pressure head 2 is pressed downwards, the piston rod 3 moves downward, compressing the space inside the drug solution bottle 1 and directing the drug solution into the annular buffer chamber guided by the flow guide cone. The drug solution forms a gentle swirling flow due to the action of the spiral flow guide groove and is then uniformly distributed on the upper surface of the microporous screen plate 6. Under the action of pressure, the drug solution passes through the micropores of the microporous screen plate 6, forming fine droplets. After entering the spray tube, the droplets are subjected to the throttling action of the throttling ring 8, controlling their initial kinetic energy, and then diffuse in the widening section before being ejected at a lower speed. Because the outlet end face of the widening section is at a 15° angle to the horizontal plane, the droplets enter the nasal vestibule at the appropriate angle, increasing the administration efficiency.

[0029] After each pressing operation is completed, the elastic reset member 4 resets the pressing head 2, the pressure inside the liquid medicine bottle 1 returns to normal, and it is ready for the next spray. The combination design of the double annular sealing rib and lubrication groove ensures smooth movement of the piston rod 3, avoiding variations in dosage due to friction fluctuations. The regular honeycomb arrangement and precise pore size control of the microporous screen plate 6 ensure concentration of the droplet particle size distribution and improve the consistency of the spray.

[0030] This invention achieves gentle atomization and precise delivery of exocrine nasal spray through the coordinated action of the flow guide cone, annular buffer chamber, microporous screen plate 6, throttling ring 8, and widening section, effectively protecting the biological activity of the exocrine system and meeting the stringent requirements for stability and reproducibility of administration devices in Parkinson's disease treatment research. The following describes the treatment process, safety, and tolerability evaluation of mesenchymal stem cell exocrine nasal spray for Parkinson's disease patients. This invention is used for administering the exocrine nasal spray.

[0031] 1. Dosage Selection Administer 1 ml of nasal spray (containing 2 x 10^10 exocrine particles, 1 x 10^10 particles in each nostril) five times a week. Continue administration for 12 weeks.

[0032] 2. Observation items and indicators (1) Basic information: demographic indicators, height, weight. (2) Pre-registration diagnosis and medical history, as well as diagnosis and treatment status. (3) Treatment information: Treatment medications. (4) Vital signs and a full physical examination. (5) General test results: complete blood count, complete urine count, blood biochemistry test, infectious disease test, electrocardiogram, serum IL-6 level. (6) Non-motor function screening: Mini-Mental State Examination (MMSE), anxiety scale, depression scale, Parkinson's disease gait. (7) Motor function screening: Unified Parkinson's Disease Rating Scale Part III (UPDRS-III). (8) General hematological tests: complete blood count, electrolytes, blood glucose, liver and kidney function tests, infectious disease tests. (9) Diagnostic imaging: Magnetic resonance imaging (MRI) of the head. (10) Electrocardiogram. (11) Chest CT.

[0033] 3. Post-registration observation indicators: Specific observation indicators for weeks 4, 8, 12, and 24 after registration. (1) Vital signs and a full physical examination. (2) General test results: complete blood count, complete urine count, blood biochemistry tests (electrolytes, blood glucose, liver and kidney function), electrocardiogram, serum IL-6 level. (3) Non-motor function screening: Mini-Mental State Examination (MMSE), anxiety scale, depression scale, Parkinson's disease gait. (4) Motor function screening: Unified Parkinson's Disease Rating Scale Part III (UPDRS-III). (5) Electrocardiogram.

[0034] 4. Long-term observation indicators after registration: (1) The observation period shall be 24 weeks. Considering the long-term therapeutic safety and efficacy issues of the ectocorticoid, an additional follow-up shall be conducted at 48 weeks to record the occurrence of adverse events and to perform a long-term safety assessment. [Explanation of symbols]

[0035] 1. Medicine bottle 2 Pressing head 3 Piston rods 4 Elastic reset member 5. Atomization Chamber 6. Microperforated screen plate 7 Nozzle Components 8 aperture rings

Claims

1. A pusher for nasal spray for exocrine disorders, A bottle of liquid medicine, Pressing component and Atomization chamber and Microperforated screen plate and Includes nozzle component, The aforementioned pressing component is connected to the liquid medicine bottle and is used to generate pressure by manual pressing to drive the liquid medicine. The atomizing chamber is installed inside the liquid chemical bottle and includes a flow guide cone and an annular buffer chamber. The flow guide cone is fixed to the center of the bottom surface inside the liquid medicine bottle and is used to guide the liquid medicine so that it is uniformly distributed along its conical surface. The aforementioned annular buffer chamber is installed surrounding the flow guide cone and is used to buffer the chemical flow velocity. The microperforated screen plate is installed inside the atomization chamber, and the microperforated screen plate has multiple micro-pores of uniform diameter, and is used to atomize the liquid chemical into droplets with concentrated particle size. The nozzle component includes a spray tube, an expanding section, and a throttling ring. One end of the spray tube is connected to the atomizing chamber, and the other end extends outside the liquid chemical bottle. The aforementioned diaphragm ring is installed on the inner wall of the widening portion, The pusher for an exocrine nasal spray is characterized in that the widening portion is installed at the outlet end of the spray tube, its inner diameter gradually increases from the inside to the outside, and is used to diffuse the mist droplets and spray them at an inclined angle.

2. The aforementioned pressing component is Pressing head and The piston rod and Includes an elastic reset member, The pressing head is located at the top of the liquid medicine bottle. The piston rod is connected to the pressing head and extends into the liquid medicine bottle. The outer wall of the piston rod is provided with two annular sealing ribs, and a lubrication groove is formed between the two annular sealing ribs. The lubrication groove is filled with lubricant. The pusher for an exocrine nasal spray according to claim 1, characterized in that the elastic reset member is mounted on the outside of the piston rod and is used for resetting after pressing.

3. A spiral flow guide groove is provided on the inner wall of the annular buffer chamber, and the spiral flow guide groove extends from the top to the bottom. The pusher for an exocrine nasal spray according to claim 2, characterized in that the microporous screen plate is located above the spiral flow guide groove, the micropore diameter of the microporous screen plate is in the range of 10 μm to 30 μm, and the micropores are arranged in a honeycomb pattern.

4. The angle between the outlet end face of the widened section and the horizontal plane is 15°. The pusher for an exocrine nasal spray according to claim 3, characterized in that the inner diameter of the throttling ring is 0.6 mm.

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