Nasal cavity treatment device

Abstract

The present invention relates to a closed system nasal treatment device, preferably in the form of a circle, square, rectangle, triangular prism, quadrilateral, pentagon, etc. Ensuring that the person using it creates a closed structure by completely wrapping the nose of the child, adult and geriatric patient population, preventing the drug from flowing out of the system, obtaining maximum efficiency from the drug, maximizing patient compliance, all liquid drug compositions in the prior art in the field are applicable.

Description

TECHNICAL FIELD

[0001] The present invention relates to a closed system nasal treatment device, preferably in the form of a circle, square, rectangle, triangular prism, quadrilateral, pentagon, etc. Ensuring that the person using it creates a closed structure by completely wrapping the nose of the child, adult and geriatric patient population, preventing the drug from flowing out of the system, obtaining maximum efficiency from the drug, maximizing patient compliance, all liquid drug compositions are applicable in the prior art in the field. BACKGROUND

[0002] The nose, as an organ for the organ of smell, is also an organ that prevents foreign substances from entering the respiratory system and is morphologically suitable for drug absorption. There are four cases for the use of the nasal cavity for drug release, respectively: local treatment, systemic treatment, vaccine release and central nervous system targeting treatment. The nasal route has been used for years to provide local effects. Some advantages of the nasal route are as follows:

[0003] The lower nasal mucosa layer is rich in blood vessels and is morphologically advantageous for drug absorption.

[0004] It has a wide absorption area due to the large number of microvilli.

[0005] The drug directly enters the systemic circulation via the nasal venous channel, thus the drug recovers from the first pass effect in the liver.

[0006] The absorption rate and blood drug concentration are at the level of intravenous injection.

[0007] It has a mucosal structure with low enzyme activity.

[0008] It has higher permeability than other mucosal structures.

[0009] Due to the high bioavailability, rapid absorption allows the drug to be administered at low doses.

[0010] It has a rapid therapeutic effect.

[0011] It allows the administration of drugs that are metabolized from the gastrointestinal tract.

[0012] The risk of overdose is low.

[0013] Macromolecules can pass through the nasal mucosa into the systemic circulation.

[0014] The human nose is a highly compatible channel that is effective in terms of drug application and easy in terms of patient compliance.

[0015] When studying the prior art, antiallergic drugs and decongestants constitute the pharmacological groups that are often administered through the nasal route. In recent years, nasal drugs targeting local action have been proposed to exhibit systemic side effects, and the nasal route can also be used to provide systemic action. In the world pharmaceutical market, the number of systemically active drugs administered through the nasal route is increasing. In addition, vaccine companies value nasal vaccines, especially respiratory infection vaccines, because the nasal mucosal immune response is very high in studies. In 2011, the first nasal influenza vaccine was marketed in Europe as an antigen-adjuvant system by a well-known company. The second influenza vaccine was marketed in 2003. The live intranasal influenza vaccine (LAIV, Flu Mist™ Quadrivalent) has been approved for the prevention of infection with influenza A and B viruses, in addition to the influenza virus vaccine administered intramuscularly, the use of a single-use 0.2 ml four-component attenuated live vaccine configured intranasally has been approved. However, after the 2015-2016 influenza pandemic, the protective efficacy against the H1N1 / Bolivian type was lower, and during the 2016-2017 and 2017-2018 influenza seasons, this vaccine, which was popular in the United States, was not recommended.

[0016] Nasal drug administration is one of the important routes for targeting the brain with drugs, which was first proposed by Dr. William II Frey in 1989. After that, many studies have been conducted on nasal drugs targeting the brain. Born et al. were able to target the cerebrospinal fluid with peptides such as melanocortin, vasopressin and insulin across the blood-brain barrier in 30 minutes in 33 healthy subjects (9 women and 27 men) [1].

[0017] Nasal drug dosage forms; nasal drops, hydrogels, powders, emulsions, ointments or special systems such as microparticles and nanoparticles. Nasal drops are the classic dosage form for the nasal route that has been used for many years. This dosage form has positive results for local disinfection applications; however, it cannot guarantee sufficient absorption to achieve the desired systemic effect. The drug applied in this form can be easily removed by the mucociliary clearance. Hydrogels have been studied to be extracted from viscous fluids to prevent mucociliary movement. There is no risk of nasal secretions in the gel dosage form and the drug adheres to the nasal cavity. Gels are very practical and effective, especially in local treatment, and their irritation potential is low. In the insulin nasal application made with a system containing polyacrylic acid-containing bioadhesive hydrogel, the desired degree of bioadhesion property was achieved. On the other hand, it has been determined that the use of excessive concentrations of these hydrogels reduces insulin release and causes the effect to occur over a longer period of time. In cases where solution or suspension dosage forms cannot be achieved, dry powder dosage forms, which are one of the nasal drug dosage forms, can be prepared. Powder dosage forms are used for locally effective drugs in the nasal cavity and allow the drug to be administered in a metered amount. However, dry powder dosage forms have serious disadvantages such as the risk of irritating the nasal mucosa and creating a sandy feeling in the tissues. In addition, dry powder dosage forms are more difficult to manufacture and are also expensive for the patient. For these reasons, powders are not suitable for nasal cavity applications. Emulsion and ointment dosage forms are also suitable for the nasal route and locally effective drugs. However, the biggest disadvantage is that the patient cannot apply, the formulation is difficult to develop, and there are problems with metered administration. There is an increasing number of studies on the nasal administration of drugs with carrier systems such as microparticles, nanoparticles, liposomes. However, the most important disadvantage of these systems is the interaction between active substances. The nasal mucosa has a long duration and nasal absorption increases. Because too much nasal absorption is not suitable for local action. These systems are prepared using biocompatible polymers, making them release prolonged and controlled.

[0018] Nasal cavity local gas-free sprays, nasal cavity local drops, nasal cavity local sticks, nasal system metered dose liquids are devices that provide nasal administration of drugs. Patient compliance is not good with these devices, especially in infants, children and elderly patients. In addition to this, these devices cannot resist mucociliary clearance because they are filled with liquid dosage forms. Since their durability in the nose is very short, their effectiveness is low.

[0019] Nasal drug administration is a major problem for neonates, infants and children in the state of the art. Device access into the nose is a challenging application, especially for neonates, infants and pediatric patients. Spraying pressurized liquid in the nose reduces patient compliance and interrupts the treatment. In addition, there are physical side effects such as irritation and burning in the nasal mucosa. They can be scared to spray the liquid medicine, can be hurt. To do this, parents must exert force on the child to keep the child stable, and in some cases, this application becomes a power workout that the child cannot explain. Psychologically, the use of force is a difficult process for both parties. It prevents drug administration at the best level. Therefore, families usually cancel the application. Nasal administration of drugs is almost as psychologically difficult for parents and children as injection drug administration.

[0020] Early children prefer to breathe through the nose; they do not like to breathe with the mouth. Neonates and infants have a long omega-shaped epiglottis in the pharynx that is positioned very close to the soft palate level compared to the elderly and adults. In addition to the absence of nasal sinuses, this results in less airflow resistance in the nasal passage than in the oral cavity. Therefore, neonates and infants prefer to breathe with the nose rather than with the oral cavity [2]. In the case of nasal congestion, the current treatment fails in practice due to the above-mentioned negative aspects. If the treatment is not completed, the child has serious sleep problems and related complications. Therefore, the existing drug technology has the obligation to develop a gentle drug administration method for children and to increase patient compliance, as well as a device that can perform these applications. Nasal cavity devices on the market do not have good patient compliance, especially for infants and children. For this reason, effective treatment cannot be provided.

[0021] A nasal spray pump is disclosed in patent application number US 2012 / 0193377 A1. In this system, there is an extended reservoir between the closed end and the open end. Here, a single dose of therapeutic agent not only concentrates on the nose, but also easily and effectively reaches areas such as hair, eyes and skin. In international patent application WO 2012 / 119153 A2; a metered dose system containing a propellant and a pressurized gas, which system can reach the olfactory region for nasal drug targeting to the brain from the drug formulation. The drug formulation is in the form of a nasal dosage form as a powder, suspension, dispersion or liquid. The push-in nasal dosage form accumulates within the olfactory region of the nasal cavity. The drug accumulated in the olfactory region is transported to the brain by avoiding the blood-brain barrier. The hydrofluoroalkane propellant is directed into a diffuser, where the nasal dosage form is atomized and enters the chamber containing the drug from the pressurized tank. The atomized nasal dosage form is delivered to the olfactory region of the user's nasal cavity as a mist through a nozzle.

[0022] In the prior art patent US 9078814 B2, active substances for use with a nasal spray device for pharmaceutical compositions are disclosed. In patent application no. US 2010 / 0122697 A1, there is a negative pressure in the first foot of the U-shaped tube system and an aerosol system in the second foot. When the negative pressure acts on one of the nostrils, the aerosol is released from the other nostril into the nasal cavity in a system with two nostrils. The invention can be used in a variety of ways for the delivery of aerosols containing drugs, in the preferred field including known aerosol delivery systems, anesthetics vaccines, metabolites, insulin and fragrances; it provides a method and system for nasal delivery of aerosols.

[0023] Patent application WO 2007 / 113551 A1 relates to a nasal spray device comprising a drug reservoir; the reservoir has a vertical plane and a neck arranged at an angle to the base portion. The invention optimizes the angle of the mouthpiece placed in the nostril in the nasal spray. The spray pump dispenser positioned here is attached to the neck by a push fit. Prior art patent application no. US 2016 / 0082204 A1 relates to a nasal spray device for delivering a pharmaceutical formulation in metered doses into the nasal cavity.

[0024] Vibrating mesh technology (VMT) nebulizers use piezoelectric ceramics and mesh to produce aerosols (liquid solution converted into micron-sized droplets), which are easy to carry, relatively quiet, and unlike ultrasonic nebulizers, do not require heating the nebulized solution [3]. The vibrating mesh technology nebulizer comprises a liquid tank with a piezoelectric mesh disc mounted on one side and a microprocessor unit with a battery-powered drive circuit board. This piezoelectric material has a mesh of thousands of precisely formed holes by laser and is in contact with the liquid solution. It vibrates at high frequency under the drive of an analog signal of a specific frequency and voltage. Due to the rapid vibration, the solution is sucked into the holes to form uniform-sized droplets (aerosols), which are delivered at a low rate for direct inhalation by the person.

[0025] The drive frequency of the piezoelectric material should be equal to the resonance frequency of the material. In this way, the nebulizer operates in its most efficient state. In addition, other factors that affect the efficient operation of the nebulizer are the nebulization characteristics, such as the solution outlet rate, mesh size and particle size, and the physical and chemical properties of the solution [4, 5].

[0026] Recent studies have shown that there is a certain relationship between the exit velocity and the voltage at a fixed resonant frequency. The exit velocity increases with an increase in the driving voltage [6]. When the driving frequency approaches the resonant frequency of the piezoelectric ceramic, the piezoelectric material vibrates at its own resonant frequency the most, and the drug solution discharge rate reaches a peak [7, 8]. However, the actual resonant frequency is different from the nominal resonant frequency given by the manufacturer. The resonant frequency depends on the impedance changes caused by the temperature and pressure of the piezoelectric material and / or the viscosity of the medium [9]. Studies have found that even a 1% inconsistency between the actual resonant frequency of the device and the signal frequency generated by the driving circuit can lead to low efficiency of the device. This 1% inconsistency can cause the droplet exit velocity of the drug from the device to deteriorate by 11%-30%, increase the droplet size by 1.6%-7.7%, and draw 6.6%-13.6% more current from the battery

[10] .

[0027] Due to the limitations and deficiencies of the prior art solutions, there is a need to provide a nasal device that forms a closed structure by completely wrapping the nose, ensuring maximum efficiency from the drug for the person using it, and preventing the drug from leaking out of the system, maximizing patient compliance. All liquid drug compositions in the prior art in the field are applicable without the need to insert the device into the nose. SUMMARY

[0028] In the present invention, a closed system nasal treatment device is disclosed, preferably in the form of a circle, square, rectangle, triangular prism, quadrilateral, pentagon, etc., and forms a closed structure by completely wrapping the nose, ensuring maximum efficiency from the drug for the person using it, and preventing the drug from leaking out of the system, maximizing patient compliance. All liquid drug compositions in the prior art in the field are applicable.

[0029] An object of the present invention is to provide an effective and practical drug application for children's noses. In addition to the optimal effective application of the drug with the device of the present invention, it is easier to apply compared to the devices of the prior art.

[0030] Another object of the present invention is to maximize patient compliance by preventing drug leakage to the outside. Drug leakage to the outside is prevented by the closed shape of the device of the present invention, which provides ease of use and perfect fit with the nose, thereby increasing patient compliance to a higher level without the need to apply pressure as in the spray type. The higher the efficiency of drug application, the lower the dose of the drug applied, and accordingly, the medication time and side effects are reduced, and patient compliance is increased. Patient compliance is increased to a higher level without the application of pressure as in the spray type of the present invention.

[0031] Another object of the present invention is to provide a device which can administer the formulation in solution form. In the device of the present invention, the formulation in solution form can be prepared more easily than the devices under the state of the art. Moreover, the absorption in the area of application and the effect resulting therefrom of the solution form is faster and more effective compared to other (semi-solid, solid, etc.) dosage forms.

[0032] The device of the present invention can be used for effective nasal drug administration to paediatrics and normal adults for many active substances available in the market. The device of the present invention has more effective application and effect, does not require arm coordination compared to other nasal drug administration devices, the person can take the drug in normal breathing pattern without the need to adopt a special posture after inserting into the nose, it stays in the area of application more effectively than other nasal drug administration routes due to being a closed system.

[0033] Another object of the present invention is to increase the effectiveness of the drug by prolonging the remaining time in the nasal cavity. When the device of the present invention is used with liquid and in situ systems (formulations which are liquid at room temperature, gelate in the nasal cavity pH and body temperature when targeted to the nose), the effectiveness of the drug is further increased by prolonging the remaining time of the drug in the nasal cavity. The device of the present invention is compatible with liquid dosage forms. The in situ systems are also in liquid form within the device and are systems which provide gelation after administration to the human body. Thus, the in situ systems are compatible with the nasal delivery device, these in situ systems are different from the liquid dosage forms since the production and filling stages are liquid dosage forms, gelate in the nasal cavity after administration, thus it can ensure that the active substance remains in the nasal cavity for a longer time.

[0034] Another object of the present invention is to distribute the drug evenly in the nasal cavity when nasal administration is performed. In the conventional nasal delivery devices (nasal nebulizers), the drug droplets coming out of the nebulizer are effective in a certain area at a certain angle, and the drug cannot reach the entire nasal cavity. The problem that the drug cannot be distributed evenly in the entire nasal cavity is the biggest disadvantage of the conventional nasal sprays and drops, the present invention eliminates this problem and ensures the even distribution of the drug in the nasal cavity. The mechanism in the nasal administration device will ensure that the drug is targeted to the nasal mucosa in the form of mist and that the drug reaches the entire nasal cavity evenly.

[0035] Another object of the present invention is to provide a painless nasal application without the need for additional instruments. Nasal drug administration does not require any action to be taken on the integrity of the body, such as inserting or pushing any device (dropper, pipette, silicone cap, etc.) into or into the nasal cavity. With the present invention, the patient painlessly and gently inhales the drug to be administered in the form of soft mist, this process does not even require awareness that the drug is administered with a closed system. Moreover, since it does not exert pressure on the nasal cavity of children like the devices in the market, the use force of the parents is eliminated by the application of the soft mist technique assisted aerosol with the present invention.

[0036] Another object of the present invention is to provide the maximum benefit to the applicator by minimizing the leakage of the drug outside the nasal cavity through a closed system.

[0037] Another object of the present invention is to provide a device with high patient compliance, especially in pediatric patients. In the present invention, the drug reservoir is embedded in the part of the device that is attached to the nose of the patient, and is remotely controlled by a piezoelectric crystal mechanism triggered by a remote electromagnetic wave. Therefore, in addition to the skeletal system attached to the nose, there is no need for a cable, a tube, or a sprayer to be connected, and there are no accessories in the design. Thus, the patient's compliance is ensured even higher, as pediatric patients do not feel that they are exposed to the mechanism.

[0038] Another object of the present invention is to provide a nasal delivery device that can administer the drug. In particular, the weight values of infants under the age of 2 change every week. The drug can be administered according to the personal information of the patient, which can be remotely controlled in the device of the present invention. According to the personal information of the patient (weight, height, age, gender, etc.), the dose of the drug to be administered to the patient can be adjusted in the device by the communication of the Bluetooth unit, the microprocessor unit, and the driving circuit of the nebulizer in the device with the smart mobile device (smartphone), triggering the piezoelectric crystal material in the skeletal system of the device.

[0039] Another object of the present invention is to ensure that the skin is not irritated and to provide comfortable breathing during the nasal application with the device. Since the carrier part of the device of the present invention attached to the nose is a sponge or a material as soft and breathable as a sponge, it provides comfortable breathing through the nose. In addition, the device does not damage the outer surface of the nose and does not irritate the skin due to the soft texture of the device.

[0040] Another object of the present invention is to ensure the optimal retention of the drug in the nasal cavity in nasal applications. The optimal retention of the drug in the nasal cavity is ensured by creating a second barrier for the aerosol vapor to escape from the device by the ladybug wing structure in the form of a shutter system that opens and closes the outer wall of the skeleton during the administration of the drug to the upper part of the skeletal system.

[0041] Another object of the present invention is to provide a product that can be easily used by adults and children in all patient groups and can be used for all liquid dosage forms of nasal drug applications on the market.

[0042] Another object of the present invention is to prevent unnecessary release of the formulation during breathing in nasal applications. In the device of the present invention, unnecessary release of the formulation during breathing is prevented by opening a special port only when breathing in the drug reservoir containing the aerosol cloud.

[0043] In addition to the local treatment of nasal and pulmonary diseases with the device developed within the scope of the invention, active substances that provide systemic effect can also be applied in these application areas. In addition, it is also possible to use the device for drug targeting brain treatment through the nasal route.

[0044] The drug dose can be adjusted according to the age, height and weight of the patient according to the invention. In addition, the drug release can also be provided and controlled by means of remote control. BRIEF DESCRIPTION OF DRAWINGS

[0045] Figure 1 : Top view of the invention.

[0046] Figure 2 : Internal side view of the invention.

[0047] Figure 3 : The exemplary operation principle of the device according to the invention is as follows; a) aerosol is depleted, battery is low, trigger signal is received, b) trigger signal is received (bluetooth, button is pressed), c) battery is full, d) resonance frequency is found.

[0048] Figure 4 : Resonance frequency scanning algorithm running on the microprocessor in the device of the invention.

[0049] Figure 5 : Circuit diagram of the piezoelectric crystal material vibration in the nasal treatment device of the invention;

[0050] Definitions of the elements / profiles / components constituting the invention

[0051] In order to better explain the invention, the components and profiles in the drawings are listed and the corresponding numerical numbers are given.

[0052] 1 - skeleton system

[0053] 2 - drug reservoir

[0054] 3 - battery

[0055] 4 - hole

[0056] 5 - atomizer

[0057] 6 - remote control

[0058] 7 - tuning wing

[0059] 100 - user DETAILED DESCRIPTION

[0060] The present invention relates to a nasal treatment device that ensures that the person using the device forms a closed structure by completely wrapping the nose, preventing the drug from escaping from the system, obtaining maximum efficiency from the drug, maximizing patient compliance. All liquid drug compositions in the prior art in the field are applicable.

[0061] The device comprises a skeleton system 1 that can be designed in different geometric shapes (circular, square, rectangular, triangular, prismatic, square, pentagonal, etc.). Preferably circular to completely cover the nose, a drug reservoir 2 (reservoir) that can be produced in tubular form or in different geometric shapes inside the system and filled with a drug in liquid form, a hole 4 that enables the liquid drug entering to be transformed into aerosol droplets with the desired particle spacing (2-15 microns) in the targeted area. An atomizer 5 that enables the dosage form in the drug chamber (reservoir) 2 to be transformed into aerosol droplets while passing through the hole 4. A remote control 6 that enables remote control of the device, a battery 3 that provides the power required for the operation of the atomizer 5 when operated with electrical energy, software that enables the atomizer 5 to be operated with a mobile phone or different signal sending devices with or without a battery 3 and to adjust the dosage according to the age, height and weight of the patient, a tuning wing 7 that has a structure in the form of a shutter system that opens and closes the outer wall of the skeleton system 1 during the application of the drug to the upper part of the skeleton system 1, while preventing the aerosol droplets released from the hole 4 in the skeleton system 1 from escaping from the device skeleton system 1. In one embodiment of the invention, the device also comprises an activation button that enables the drug to be targeted into the nasal cavity, providing slow and gentle drug release when activated / pressed. In one embodiment of the invention, the nasal treatment device also operates with a battery in addition to a solar cell or by remote charging / wireless charging.

[0062] In another embodiment of the invention, the nasal treatment device;

[0063] The skeleton system 1 has a structure that completely covers the nose and preferably has a circular shape and surrounds the mechanism from the outside,

[0064] The drug reservoir 2 can be produced in tubular form or in different geometric shapes inside the mechanism and filled with a drug in liquid form,

[0065] The piezoelectric crystal material is located next to the drug reservoir 2 inside the skeleton system 1,

[0066] The battery 3 provides the power required for the operation of the atomizer 5 when it is in operation;

[0067] The hole 4 enables the drug in liquid form entering to be transformed into aerosol droplets with the desired particle ratio in the targeted area,

[0068] The nebulizer 5 allows the dosage form in the drug reservoir 2 to become aerosol droplets as it passes through the hole 4, the nasal treatment device is operated with a smart mobile device and the dosage is adjusted according to the age, height, weight and / or gender of the patient.

[0069] The adjustment wing 7 opens during the application of the drug to the upper part of the skeleton system 1 and has a shutter system form of structure to close the outer wall of the skeleton system 1 while preventing the aerosol droplets released from the hole 4 from escaping from the device skeleton system 1.

[0070] In this embodiment, the device can also include a remote control 6 or a mobile device containing Bluetooth, the device can be controlled remotely and in this embodiment the device can also include an activation button.

[0071] The operation principle of the nasal treatment device is divided into two stages. First, the drug in liquid form is directed by the electronic system to the micro hole 4 that will form the aerosol form, in this way, it is ensured that a soft mist or precise spray content that can move slowly is formed. In the second stage, it is ensured by the skeleton system 1 that the aerosol droplets released from the device reach the nasal cavity without loss. The invention is placed in the user's nose, when ready, it provides a soft mist aerosol cloud release during the application period, which is an average of 5 minutes, although it varies according to the type of drug and the purpose of use by the patient. Nasal drug application is based on electromechanical aerosol-generating systems such as vibrating screen method.

[0072] The drug reservoir 2 includes a soft mist aerosol containing a drug in liquid form for nasal application; and has a compact structure with the entire device. The skeleton system 1 is preferably sponge-like, preferably spherical, with the feature of covering the nose in a compact structure. When the skeleton system 1 of the device is inserted into the nasal cavity and the activation button is pressed, the drug in liquid form saved in the drug reservoir 2 enters the nose by slow and gentle release. The drug reservoir 2 embedded in the skeleton system 1 connected to the nasal cavity can be triggered by remote electromagnetic waves by piezoelectric crystal material, controlled by the remote control 6. The piezoelectric crystal material is located next to the drug reservoir 2 in the skeleton system 1. Age-weight-dose calculation and tracking will be possible with a software program installed on a smart phone or a control panel designed for the device, the dose is controlled by the remote control 6. The nebulizer 5 includes a Bluetooth unit, a microprocessor unit, a drive circuit.

[0073] After finding the resonance frequency of the piezoelectric crystal material used in the nasal treatment device of the invention, the device should be operated. For this reason, first the drive circuit in the device is used to find this resonance frequency. In Figure 3The exemplary operating principle of the device according to the present invention is given below. The first operation of the device is activated by mechanically pressing an activation button on the device or by wirelessly sending a trigger signal via Bluetooth from a smartphone application. The battery status is then checked, and if appropriate, the microprocessor unit and drive circuitry initiate a frequency scanning process to find the actual resonant frequency of the piezoelectric material. After finding the frequency, the drive circuitry drives the piezoelectric material with an analog signal of a specified voltage and frequency, causing the piezoelectric material to vibrate. If the liquid state in the drug container is complete, or a stop trigger signal indicating insufficient battery power is received, the drive circuitry stops the drive signal and terminates the operation.

[0074] exist Figure 4 This paper presents a resonant frequency scanning algorithm running on a microprocessor. The algorithm finds the true resonant frequency of a piezoelectric crystal material by scanning between a start frequency and an end frequency. The start and end frequencies can be selected to be 10% below and above the material's nominal resonant frequency, respectively. After setting the start frequency, an analog signal is applied to the material using a drive circuit, and the current is then read. Each time the current is read, the frequency with the maximum current signal is recorded by continuously generating signals within the defined frequency range. At the end of the scan, the frequency at which the maximum current signal is drawn from the cell is the true resonant frequency of the piezoelectric crystal material.

[0075] exist Figure 5 The circuit block diagram of the vibration of the piezoelectric crystal material in the nasal cavity treatment device of the present invention is given.

[0076] The operation method of the nasal cavity treatment device of the present invention is as follows;

[0077] The device ensures communication between the smartphone and the device via Bluetooth and obtains the patient's height, weight, age and / or gender information in order to adjust the drug dosage for the patient. The resulting trigger signal is transmitted to the microprocessor unit, which processes the trigger signal from the microprocessor unit and determines the resonant frequency of the piezoelectric crystal material.

[0078] A signal is generated at the resonant frequency determined by the microprocessor unit and transmitted to the piezoelectric crystal material via a drive circuit.

[0079] Vibration of piezoelectric crystal materials

[0080] By triggering the vibration of the piezoelectric crystal material, the drug reservoir 2 is sprayed through the hole 4 to convert the drug into aerosol droplets of a particle size determined according to the drug dosage adjusted for the patient based on personal data.

[0081] In normal mode of operation, the device now continues to communicate with the smart mobile device (e.g. smartphone). The smartphone application can be used both before the device starts operating and while it is running. Settings such as user selection, dose selection, time selection can also be made via the smart mobile device before the device starts working. In addition, the height, weight, age and / or gender information of the patient can also be selected via the smart mobile device and the dose to be administered to the patient is determined based on this information. Furthermore, in one embodiment of the present invention, the information read from the sensors in the device (e.g. the date and time of the user's use of the nasal treatment device, the pressure, temperature, humidity and direction while using the device) is transmitted to the smart mobile device via the Bluetooth unit in the device and recorded by the application here.

[0082] The operating system of the device is a closed system that covers the entire nasal cavity, first releasing the drug from the drug reservoir 2 placed inside the skeletal system 1. Here, the dose of the drug is adjusted according to factors such as the patient's age, gender, height-weight ratio, etc. and reaches the desired level by the developed software. Then, the 128,000 holes of the atomizer 2, using the electric energy and vibrating mesh technology (VMT), start to vibrate, the dosage form (solution, emulsion or suspension) in the drug reservoir turns into aerosol droplets as it passes through this vibrating mesh system.

[0083] When the drug needs to be targeted to the nose and brain, the particle size of the aerosol droplets should be 10-15 microns. When the local drug needs to be targeted to the lungs, the particle size of the aerosol droplets should be 2-6 microns. When the systemic drug needs to be targeted to the lungs, the particle size of the aerosol droplets should be less than 1 micron. The difference in size here is achieved by the holes 4 in the skeletal system 1 of the device and the vibration frequency of the holes.

[0084] The skeletal system 1 connected to the nose part of the device is composed of a sponge-like material. However, as an alternative, the material of the skeletal system 1 can be made of plastic, sponge rubber, polymer-derived materials this time, which are compatible with the human body and do not cause any harm. The tuning wing 7 has a structure in the form of opening a thin shutter system on the skeletal system 1, creating a second obstacle for the aerosol vapor to escape from the device, and ensuring the best drug to stay in the nasal cavity during the application of the drug.

[0085] In another embodiment of the invention, the device can be used without electrical energy. In this use, the electrically powered form of the nebulizer 5, the battery 3 that provides energy for the nebulizer 5 and the software designed according to the nebulizer 5 are removed from the system; there is an airbag in the skeleton system 1 of the device, at least one syringe is in contact with this airbag. The air inside the syringe applies mechanical force to the airbag and ensures that the airbag inflates and forms pressure in it. When the syringe is filled with air, an average pressure of 10 bar occurs. The airbag can ensure the delivery of the drug solution inside the drug reservoir to the hole 4 system at this pressure, and there is also the tuning wing 7 that prevents the aerosol droplets from escaping outside. In such use, since the nebulizer 5 is removed from the system, the electronic system becomes a mechanical system.

[0086] In another embodiment of the invention, there is a spring system placed inside the skeleton system 1 and a latch connected to the spring system. The latch is placed outside the skeleton system 1 of the device, when the latch is started to be turned by hand, the spring system starts to stretch and provides energy to push the dosage form in the drug reservoir 2 to the nasal spray. The nasal spray contained here is the system that sprays the liquid used for washing the nose in the traditional nose drops into the nose. This system is placed at an angle inside the closed skeleton system 1, the angle is the corresponding angle for the two nostrils. The pressure is provided by the mechanical system instead of the electronic system, which is close to the drug reservoir 2, the hole 4 and the tuning wing 7 in this system, the pressure is the mechanical system mentioned in the alternative embodiments above.

[0087] In the alternative embodiments mentioned above, if the drug reservoir 2, the hole 4 and the tuning wing 7 remain the same, this makes it possible to use the system mechanically instead of electronically in the case where the pressure of the system operation is not electrical or the battery is not powered.

[0088] The device according to the invention requires a maximum of 300 μL of the reservoir area at the time of application 5 minutes. The droplet size of the aerosol released or sprayed from the device is between 10 μm-15 μm for targeting the nose and the brain, 2 μm-6 μm for local drug targeting to the lungs, and below 1 micron for systemic drug targeting to the lungs.

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Claims

1. A closed system nasal treatment device for children and adults, arranged in a circular, rectangular, triangular prism, quadrangular or pentagonal form and ensuring that the person using the device forms a closed structure by completely wrapping his nose, preventing the drug from flowing out of the system, obtaining maximum efficiency from the drug and maximizing patient compliance, characterized in that, The device comprises the following; A skeleton system (1) having a structure that covers the nose completely and surrounds from the outside the components placed inside it; A drug reservoir (2) that can be produced in a tubular form or in different geometrical shapes inside the skeleton system and filled with the drug in liquid form; A battery (3) that provides the power required for the operation of the atomizer (5); A hole (4) that enables the drug in liquid form to be transformed into aerosol droplets with the desired particle ratio in the targeted area; An atomizer (5) that allows the dosage form in the drug reservoir (2) to be transformed into aerosol droplets as it passes through the hole (4); A remote control (6) that allows remote control of the device; Software that enables the atomizer (5) to be operated with a mobile phone or a different signal sending device with or without the battery (3) and adjusts the dosage according to the age, height and weight of the patient; A tuning wing (7) that opens during the period when the drug needs to be administered through the upper part of the skeleton system and has a structure in the form of a shutter system to close the outer wall of the skeleton system (1) while preventing the aerosol droplets released from the hole (4) from escaping from the skeleton system (1) of the device; The drug reservoir (2), the battery (3), the hole (4) and the atomizer (5) are placed inside the skeleton system (1).

2. The nasal treatment apparatus of claim 1, wherein, The battery is charged by wired or wireless means.

3. The nasal treatment apparatus of claim 1, wherein, It includes an activation button that can target the drug into the nose, and when activated / pressed, it can release the drug slowly and gently.

4. A nasal treatment device that ensures that the person using the device forms an enclosed structure by completely wrapping the nose, preventing the drug from flowing out of the system, obtaining maximum efficiency from the drug and maximizing patient compliance, characterized in that, The device comprises the following; A skeleton system (1) having a structure that covers the nose completely, having a circular shape and surrounding from the outside the components placed inside it; A drug reservoir (2) that can be produced in a tubular form or in different geometrical shapes inside the skeleton system and filled with the drug in liquid form; A piezoelectric crystal material located next to the drug reservoir (2) inside the skeleton system (1); A battery (3) that provides the power required for the operation of the atomizer (5); A hole (4) that enables the drug in liquid form to be transformed into aerosol droplets with the desired particle ratio in the targeted area; An atomizer (5) that allows the dosage form in the drug reservoir (2) to be transformed into aerosol droplets as it passes through the hole (4), operates the nasal treatment device using a smart mobile device and adjusts the dosage according to the age, height, weight and / or gender of the patient; A tuning wing (7) that opens during the period when the drug needs to be administered through the upper part of the skeleton system and has a structure in the form of a shutter system to close the outer wall of the skeleton system (1) while preventing the aerosol droplets released from the hole (4) from escaping from the skeleton system (1) of the device; The drug reservoir (2), the battery (3), the hole (4) and the atomizer (5) are placed inside the skeleton system (1).

5. The nasal treatment apparatus of claim 4, wherein, The atomizer (5) includes a Bluetooth unit, a microprocessor unit, a drive circuit.

6. The nasal treatment apparatus of Claim 5, wherein, It also includes a remote control (6) or a mobile device containing Bluetooth, which can remotely control the device.

7. The nasal therapy device according to any one of claims 4-6, wherein, It also includes an activation button.

Images