INTRANASAL TREATMENT DEVICE

Abstract

The present invention relates to a closed system intranasal treatment device that is preferably in round, square, rectangular, triangular prism, quadrilateral, pentagon etc. form and that ensures the person who will use it gets maximum efficiency from the drug by creating a closed structure by completely wrapping noses of pediatric, adult and geriatric patient groups and preventing the drug from passing out of the system and maximizes patient compliance, in which all liquid pharmaceutical compositions in the state of the art are applicable.

Claims

1. A closed system nasal treatment device for children and adults, that is preferably in round, square, rectangular, triangular prism, quadrilateral, pentagon etc. form and that ensures the person who will use it gets maximum efficiency from the drug by creating a closed structure by completely wrapping their noses and preventing the drug from passing out of the system and maximizes patient compliance, in which all liquid pharmaceutical compositions in the state of the art are applicable, characterized in that; it comprises the following; skeletal system (1), which has a structure to completely cover the nose and preferably has a round shape and surrounds the mechanism from the outside, drug reservoir (2), which can be produced in the form of a tube or in different geometric shapes inside the mechanism and filled with drugs in liquid form, battery (3), which provides the power that the nebulizer (5) needs while working, holes (4) that enable the incoming drug in liquid form to transform into aerosol droplets with the desired particle ratio in the targeting region, nebulizer (5) which allows the dosage form in the drug chamber (2) (reservoir) to become aerosol droplets as it passes through the holes (4), remote control (6) that allows the device to be controlled remotely, software that enables the nebulizer (5) to be operated with or without a battery (3) with a mobile phone or different signal sending devices, and to adjust the patient doses according to age, height and weight, ladybug wings (7) which opens during drug administration to the upper part of the skeletal system and has a structure in the form of a shutter system to close the outer wall of the skeletal system (1) and at the same time prevents aerosol droplets released from the holes (4) from escaping out of the device skeletal system (1).

2. A nasal treatment device according to claim 1, characterized in that; the shape of the skeletal system (1) is round ball, square, rectangular, triangular prism, quadrilateral or pentagon.

3. A nasal treatment device according to claim 1, characterized in that; the skeletal system (1) is in the form of round ball.

4. A nasal treatment device according to any of the preceding claims, characterized in that; the invention can be charged apart from the cell battery via battery, wired or wirelessly.

5. A nasal treatment device according to any of the preceding claims, characterized in that; it comprises an activation button that can target the drug into the nose, providing a slow and gentle drug release when activated/pressed.

6. An operating method of the intranasal therapy device according to claim 5, characterized in that; it comprises the following process steps; turning on the device by activating the activation button ensuring communication between the smart mobile device and the intranasal treatment device via the Bluetooth unit and taking the patient's height, weight, age and/or gender information required to adjust the drug dose for the patient, and transmitting the trigger signal generated for this to the microprocessor unit, processing of the trigger signal coming to the microprocessor unit by the microprocessor unit and determining of the resonance frequency of the piezoelectric crystal material, generating a signal at the resonant frequency determined by the microprocessor unit and transferring it to the piezoelectric crystal material by means of the driver circuit, vibration of piezoelectric crystal material, spraying the drug, which is transformed into aerosol droplets in particle size determined according to the drug dose adjusted for the patient according to the personal data, through the holes (4) by triggering the medicine chamber (2) of the vibrating piezoelectric crystal material.

7. An intranasal treatment device which ensures that the person who will use it gets maximum efficiency from the drug by creating a closed structure by completely wrapping their noses and preventing the drug from passing out of the system and maximizes patient compliance, in which all liquid pharmaceutical compositions in the state of the art are applicable, characterized in that, it comprises the following; a skeletal system (1), which has a structure to completely cover the nose and preferably has a round shape and surrounds the mechanism from the outside, a drug reservoir (2), which can be produced in the form of a tube or in different geometric shapes inside the mechanism and filled with drugs in liquid form, a piezoelectric crystal material located next to the drug reservoir (2) inside the skeletal system (1), battery (3), which provides the power that the nebulizer (5) needs while working, holes (4) that enable the incoming drug in liquid form to transform into aerosol droplets with the desired particle ratio in the targeting region, a nebulizer (5) which allows the dosage form to become aerosol droplets as it passes through the holes (4) contained in the drug reservoir (2), operates the intranasal treatment device with a smart mobile device and adjusts patient doses according to their age, height, weight, and/or gender, ladybug wings (7), which is opened during drug administration to the upper part of the skeletal system and has a structure in the form of a shutter system to close the outer wall of the skeletal system (1), and at the same time prevents aerosol droplets released from the holes (4) from escaping out of the device skeletal system (1).

8. An intranasal treatment device according to claim 7, characterized in that; nebulizer (5) comprises Bluetooth unit, microprocessor unit, driver circuit.

9. An intranasal treatment device according to claim 8, characterized in that; it further comprises a remote control (6) or a mobile device containing Bluetooth that allows the device to be controlled remotely.

10. An intranasal treatment device according to any of the claims 7-9, characterized in that; it further comprises activation button.

11. Operating method of the intranasal therapy device according to claim 10, characterized in that; it comprises the following process steps; turning on the device by activating the activation button, ensuring communication between the smartphone and the device via the Bluetooth unit and taking the patient's height, weight, age, and/or gender information required to adjust the drug dose for the patient, and transmitting the trigger signal generated for this to the microprocessor unit, processing the trigger signal coming to the microprocessor unit by the microprocessor unit and determining the resonance frequency of the piezoelectric crystal material, generating a signal at the resonant frequency determined by the microprocessor unit and transferring it to the piezoelectric crystal material by means of the driver circuit, vibration of piezoelectric crystal material, spraying the drug, which is transformed into aerosol droplets in particle size determined according to the drug dose adjusted for the patient according to the personal data, through the holes (4) by triggering the medicine chamber (2) of the vibrating piezoelectric crystal material.

Description

DESCRIPTION OF THE FIGURES

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

[0046] FIG. 2: Side view of the interior of the invention.

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

[0048] FIG. 4: The resonant frequency scanning algorithm to run on the microprocessor in the device of the present invention.

[0049] FIG. 5: Circuit block diagram for the vibration of the piezoelectric crystal material in the intranasal treatment device of the present invention.

DEFINITIONS OF ELEMENTS/SECTIONS/PARTS THAT CONSTITUTE THE INVENTION

[0050] The parts and sections in the figures are enumerated and the corresponding of each number is given below in order to better explain this invention: [0051] 1—Skeletal System [0052] 2—Drug Reservoir [0053] 3—Battery [0054] 4—Holes [0055] 5—Nebulizer [0056] 6—Remote Control [0057] 7—Ladybug Wings [0058] 100—User

DETAILED DESCRIPTION OF THE INVENTION

[0059] The present invention relates to an intranasal treatment device which ensures that the person who will use it gets maximum efficiency from the drug by creating a closed structure by completely wrapping their noses and preventing the drug from passing out of the system and maximizes patient compliance, in which all liquid pharmaceutical compositions in the state of the art are applicable.

[0060] It comprises skeletal system (1) that can be designed in different geometric shapes (round, square, rectangle, triangle, prism, square, pentagon, etc.) preferably round to completely cover the nose, drug reservoir (2) (reservoir), which can be produced in the form of a tube or in different geometric shapes within this system and filled with drugs in liquid form, holes (4) that allow the incoming liquid drug to become aerosol droplets with the desired particle spacing (2-15 micrometers) in the targeting region, nebulizer (5), which enables the dosage form in the medication chamber (reservoir) (2) to become aerosol droplets as it passes through the holes (4), remote control (6), which allows the device to be controlled remotely, battery (3), which provides the power needed by the nebulizer (5) while operating with electrical energy, software that enables the nebulizer (5) to be operated with or without a battery (3) with a mobile phone or different signal sending devices, and to adjust the patient doses according to age, height and weight, ladybug wings (7) which has a structure in the form of a shutter system that opens to the upper part of the skeletal system (1) during drug application and that will close the outer wall of the skeletal system (1) and at the same time prevents aerosol droplets released from the holes (4) in the skeletal system (1) from escaping out of the device skeletal system (1). In one embodiment of the invention, the device further comprises an activation button that can target the drug into the nose, providing a slow and gentle drug release when activated/pressed. In an embodiment of the invention, the nasal treatment device also has the opportunity to operate with a battery other than a cell battery or to operate by being charged remotely/wirelessly.

[0061] In another embodiment of the invention, said intranasal treatment device; [0062] skeletal system (1), which has a structure to completely cover the nose and preferably has a round shape and surrounds the mechanism from the outside, [0063] drug reservoir (2), which can be produced in the form of a tube or in different geometric shapes inside the mechanism and filled with drugs in liquid form, [0064] a piezoelectric crystal material located next to the drug reservoir (2) inside the skeletal system (1), [0065] battery (3), which provides the power that the nebulizer (5) needs while working, [0066] holes (4) that enable the incoming drug in liquid form to transform into aerosol droplets with the desired particle ratio in the targeting region, [0067] nebulizer (5) which allows the dosage form to become aerosol droplets as it passes through the holes (4) contained in the drug reservoir (2), operates the intranasal treatment device with a smart mobile device and adjusts patient doses according to age, height, weight and/or gender, [0068] ladybug wings (7) which opens during drug administration to the upper part of the skeletal system (1) and has a structure in the form of a shutter system to close the outer wall of the skeletal system (1) and at the same time prevents aerosol droplets released from the holes (4) from escaping out of the device skeletal system (1)

[0069] In this embodiment, said device may also comprise a remote control (6) or a mobile device containing Bluetooth that allows the device to be controlled remotely. Also in this embodiment, said device may further include an activation button.

[0070] The operating principle of the nasal treatment device is in two-stages. First, the drug in liquid form is directed by an electronic system to the micro-sized holes (4) that will form the aerosol form, in this way, the formation of soft mist or precise spray content that can move slowly is ensured. The aerosol droplets released from the device are ensured to reach the nasal cavity without loss by means of the skeleton system (1) in the second stage. The present invention is placed in the nose of the user and when it is ready, it provides a soft mist aerosol cloud release during the application period of 5 minutes on average although it varies according to the type of drug and for what purpose the patient uses it. Nasal drug administration is based on an electromechanical aerosol generation system such as the vibrating screen method.

[0071] The drug reservoir (2) comprises a soft mist aerosol containing medicine in liquid form for nasal administration; it has a compact structure with the entire device. The skeletal system (1) is preferably spongy, preferably ball-shaped, with the feature of covering the nose in a compact structure. The drug in liquid form, which is kept in the drug reservoir (2), will target the drug into the nose by providing a slow and gentle release when the device skeletal system (1) is inserted into the nose and the activation button is pressed. The drug reservoir (2), which is embedded in the skeletal system (1) attached to the nose, can be controlled by a remote control (6) by means of a piezoelectric crystal material to be triggered by remote electromagnetic waves. Said piezoelectric crystal material is located in the skeletal system (1) next to the drug reservoir (2). Age-weight-dose calculation and follow-up will be possible with a software program to be installed on the smart phone or the control panel designed for this device by means of the dosing controllable with the remote control (6). Nebulizer (5) comprises Bluetooth unit, microprocessor unit, driver circuit.

[0072] After the resonance frequency of the piezoelectric crystal material used in the intranasal therapy device of the invention is found, the device should be operated. For this reason, the driver circuit in the device is first used to find this resonant frequency. In FIG. 3, the exemplary operating principle of the device according to the present invention is given. The first operation of the device is enabled either by means of pressing the activation button on the device mechanically or by sending a trigger signal wirelessly from a smartphone application via Bluetooth. Then the battery status is checked and if appropriate, the microprocessor unit and the driver circuit start the frequency scanning process and finds the actual resonant frequency of the piezoelectric material. After the frequency is found, the driver circuit drives the piezoelectric material with an analog signal at the specified voltage and frequency and the piezoelectric material vibrates. If the liquid form in the medicine tank is finished, or if a stop trigger signal is received with a low battery, the driver circuit stops driving the signal and operation is terminated.

[0073] In FIG. 4, the resonant frequency scanning algorithm to run on the microprocessor is given. This algorithm finds the true resonance frequency of the piezoelectric crystal material by scanning between the start and end frequencies. The start and end frequencies can be selected as 10% below and above the nominal resonance frequency of the material. After the initial frequency is set and the analog signal is applied to the material with the driver circuit, the current is read. The current is read each time and the frequency of the signal with the greatest current is recorded by continuing to generate the signal in the determined frequency range. At the end of scanning, the frequency of the signal that draws the greatest current from the battery is the true resonance frequency of the piezoelectric crystal material.

[0074] In FIG. 5, circuit block diagram for the vibration of the piezoelectric crystal material in the intranasal treatment device of the present invention is given.

[0075] The operating method of the intranasal therapy device of the present invention is as follows; [0076] Ensuring communication between the smartphone and the device via the Bluetooth unit and taking the patient's height, weight, age and/or gender information required to adjust the drug dose for the patient, and transmitting the trigger signal generated for this to the microprocessor unit, [0077] Processing of the trigger signal coming to the microprocessor unit by the microprocessor unit and determining of the resonance frequency of the piezoelectric crystal material, [0078] Generating a signal at the resonant frequency determined by the microprocessor unit and transferring it to the piezoelectric crystal material by means of the driver circuit, [0079] Vibration of piezoelectric crystal material, [0080] Spraying the drug, which is transformed into aerosol droplets in particle size determined according to the drug dose adjusted for the patient according to the personal data, through the holes (4) By triggering the medicine chamber (2) of the vibrating piezoelectric crystal material.

[0081] In normal operating mode, the device now continues to communicate with the smart mobile device (e.g. smart phone). The smartphone application is used both before the device starts to operate and while it is running. Before the device starts to work, settings such as user selection, dose selection, time selection can also be made via the smart mobile device. Also, selecting patient's height, weight, age and/or gender information via the smart mobile device can be performed and the dose to be given to the patient is determined according to this information. Furthermore, in an embodiment of the invention, the information read from the sensors in the device such as the date and time when the user uses the intranasal therapy device, the pressure, temperature, humidity and orientation in the device while it is being used are sent to the smart mobile device via the Bluetooth unit in the device and recorded via the application here.

[0082] The operating system of the device, which is a closed system to cover the entire nose, starts with the release of the drug from the drug reservoir (2) placed inside the skeletal system (1). Here, the dosage of the drug is adjusted according to factors such as the patient's age, gender, height-weight ratio, and pumped at the required level via the developed software. Then, the 128,000 holes of the nebulizer, which uses electrical energy and vibrating screen technology (VMT), begin to vibrate, the dosage form (solution, emulsion or suspension) in the drug reservoir turns into aerosol droplets while it passes through this vibrating screen system.

[0083] When it is desired to target drugs to the nose and brain, the particle size of aerosol droplets should be 10-15 micrometers. When it is desired to target local drugs to the lungs, the particle size of aerosol droplets should be 2-6 micrometers. When it is desired to target systemic drugs to the lungs, aerosol droplets should have a particle size below 1 micrometer. The size difference here is realized by the holes (4) and the vibration frequency of the holes in the skeletal system (1) of the device.

[0084] The skeletal system (1) attached to the nose of the device consists of a spongy material. However, as an alternative to this, the material of the skeletal system (1) can be made of plastic, sponge rubber, polymer-derived materials that are compatible with the body and do not cause any harm. The ladybug wings (7), which have a structure in the form of a thin shutter system to be opened on the skeletal system (1), which is produced in a spongy structure, creates a second obstacle for the aerosol vapor to escape from the device and ensures that the optimum drug remains in the nose during the application of drug.

[0085] In another embodiment of the invention, it is possible to use the device without electrical energy. In such usages, the electric nebulizer (5), the battery (3) providing energy to the nebulizer (5) and the software designed in accordance with the nebulizer (5) are removed from the system; there is an air balloon in the skeletal system (1) of the device and at least one syringe in contact with this air balloon. The air within the syringe applies mechanical force to the air balloon and ensures the air balloon to inflate and the formation of pressure therein. When the syringe is filled with air, an average pressure of 10 bar occurs. There are air balloons that ensure the delivery of the drug solution inside the drug reservoir to the hole system (4) with this pressure, and ladybug wings (7) that prevent the escape of aerosol droplets to the outside. In such uses, the electronic system becomes mechanical since the nebulizer (5) is removed from the system.

[0086] In another embodiment of the invention, there is a spring system placed inside the skeletal system (1) and a latch in connection with this spring system in the device. This latch is placed outside the skeletal system (1) of the device, the spring system starts to stretch when the latch is started to be turned by hand and this energy is provided to push the dosage form in the drug reservoir (2) to the nasal spray jet. The nasal spray jet contained here is the system in which the liquid used in nasal washing solutions in traditional nasal drops is sprayed into the nose. This system provides placement within the closed skeletal system (1) at an angle that targets both nostrils at an angle corresponding to the nostrils. Pressure is provided by a mechanical system, not an electronic system, next to the drug reservoir (2), the holes (4) and the ladybug wings (7) in this system. This pressure is a mechanical system as mentioned in the alternative embodiment above.

[0087] In the alternative embodiments mentioned above, the drug reservoir (2), the holes (4) and the ladybug wings (7) remain the same, making it possible to use the system mechanically instead of electronically in cases where the pressure that enables the system to operate is not electrical or the battery is dead.

[0088] The device according to the present invention requires a reservoir area of 300 μL at most for 5 minutes of application. The droplet size of the aerosols to be released or sprayed from the device is in the range of 10-15 μm for targeting to the nose and brain, 2-6 μm for local drug targeting to the lungs, and below 1 micrometer for systemic drug targeting to the lungs.

REFERENCES

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