Accurate delivery device and accurate drug administration control method for delivering pharmaceutical aerosol

Abstract

The present invention provides an accurate delivery device and accurate drug administration control method for delivering a pharmaceutical aerosol. The accurate delivery device for delivering a pharmaceutical aerosol comprises: a housing, sized and shaped to be held in the hand of a user; a drug cartridge assembly, which can nebulize a set dose of drug into an aerosol, wherein an aerosol channel used for conveying the aerosol is formed in the drug cartridge assembly; a flow generator, which is used for generating positive pressure airflow for conveying the aerosol to the respiratory tract; and a control unit, which is used for receiving an operation instruction, driving the drug cartridge assembly to output the pharmaceutical aerosol, and driving the flow generator to generate positive pressure airflow, wherein the drug cartridge assembly, the flow generator, and the control unit are all accommodated in the housing. The present invention has the beneficial effects of being small in structure, easy to carry, convenient to use and capable of carrying out accurate drug administration.

Description

Precision delivery device for delivering drug aerosol and precision drug delivery control method Technical Field

[0001] The present invention relates to the technical field of aerosolized drug delivery, and in particular to a precise delivery device for delivering drug aerosols and a precise drug delivery control method. Background Art

[0002] Nasal / oral inhalation is a very special route of administration that can be used to prevent and treat diseases of the central nervous system, respiratory system and other aspects. (1) Studies have confirmed that there is a direct anatomical channel between the brain tissue and the nasal cavity. Intranasal administration bypasses the blood-brain barrier and directly delivers drugs to the brain non-invasively. That is, drugs can reach the central nervous system through the olfactory epithelium or respiratory epithelium of the nasal mucosa, quickly enter the brain tissue and interact with relevant receptors to produce therapeutic effects. The nose-brain connection can also trigger and regulate the olfactory-amygdala neural circuit by activating peripheral nasal chemical sensory neurons without the need for drugs to directly bind to neuronal receptors in the brain's central nervous system, thereby limiting the transport of molecules to the blood circulation system and minimizing the potential systemic exposure of drugs. Regardless of the mechanism, its characteristics are to avoid the blood-brain barrier, alveolar blood-gas barrier, liver first-pass effect and gastrointestinal metabolism, so the required dose is the lowest (10-6-10-12g), the onset is the fastest (a few seconds), the systemic toxicity and side effects are the lowest, and the compliance is the best. (2) Studies have confirmed that pulmonary absorption is also a good route of drug administration. The characteristics of lung-targeted drug administration are: large absorption surface area, rich capillary network, and thin alveolar air-blood barrier, which can avoid gastrointestinal metabolism and liver first-pass effect; the dosage required is lower than oral and injection administration, the onset is faster, the systemic toxicity and side effects are small, and the compliance is good. (3) Studies have confirmed that other non-central nervous system and non-respiratory system drugs can also achieve better prevention and treatment effects of diseases through nasal / oral atomization inhalation administration, such as peptide diabetes drugs that require frequent injections, osteoporosis drugs, hormone drugs and other oral and injectable drugs that require rapid onset. Modifying them into inhalation dosage forms to meet user needs has very practical significance.

[0003] Nebulized inhalation dosage forms refer to preparations in which drugs are administered using a special device and inhaled through the deep respiratory tract, cavities, mucous membranes, etc. to exert local or systemic therapeutic effects, thereby achieving the purpose of painless, rapid and effective treatment.

[0004] Respiratory inhalation compositions can be further divided into liquid nebulizer inhalers, metered dose inhalation aerosols, dry powder inhalers and soft mists. Liquid nebulizer inhalers, as a specific dosage form for respiratory drug administration, are usually aqueous solutions. A specific device is used to convert the nebulized inhaled drug into an aerosol for the user to inhale. The inhaled dose is deposited at different lesion sites in the respiratory tract at a certain rate and with an appropriate particle size. The particle size of the aerosol has been widely studied by researchers as the main factor affecting the deposition site of respiratory drug administration; another factor is the user's inhalation strength and breathing habits. The same nebulizer and nebulizer will produce different inhalation doses and drug deposition in different sites for different users, thus producing different therapeutic effects. Aerosols, dry powder inhalers and soft mists have the same problem of inaccurate atomization dose, inhalation dose and deposition site.

[0005] Existing nebulization inhalation therapy equipment usually includes a nebulizer device, a liquid medicine storage device, a nebulizer output tube, etc. Some even require an oxygen storage device. The structure is relatively complex and large, the cost is high, and it is inconvenient to use and maintain. It is generally only suitable for use in hospitals or other fixed places. It is not convenient to transport and carry, and it is impossible to accurately nebulize, accurately inhale and accurately deposit the medicine.

[0006] Summary of the Invention

[0007] In order to overcome the above-mentioned deficiencies of the prior art, on the one hand, the present invention provides a precise delivery device for delivering drug aerosols, which has the beneficial effects of being compact, easy to carry, easy to use, and capable of precise drug administration.

[0008] On the other hand, the present invention provides a precise drug delivery control method for delivering aerosols through positive pressure airflow, which is applicable to the above-mentioned precise delivery device, realizes intelligent and personalized atomization drug delivery, and improves the treatment effect.

[0009] In order to achieve the above object, the technical solution adopted by the present invention is as follows:

[0010] A precision delivery device for delivering drug aerosols, comprising:

[0011] a housing sized and shaped to be held in a hand of a user;

[0012] a drug cartridge assembly capable of atomizing a set dose of drug into an aerosol, wherein the drug cartridge assembly has an aerosol passage for conveying the aerosol;

[0013] a flow generator for generating a positive pressure airflow for delivering the aerosol to the respiratory tract; and

[0014] a control unit, which drives the drug cartridge assembly to output drug aerosol according to a user's operation instruction, and drives the flow generator to generate a set amount of positive pressure airflow;

[0015] The ammunition assembly, the flow generator and the control unit are all received in the housing. The above technical solution can be further improved by the following measures.

[0016] As a preferred embodiment, the ammunition assembly includes:

[0017] a powder cartridge case, the interior of which defines a powder storage compartment; and

[0018] A nebulizer is positioned in the drug cartridge to aerosolize the drug.

[0019] Specifically, a base is attached to the bottom of the drug cartridge case, and the base and the drug cartridge case together define the drug storage chamber.

[0020] Specifically, the base is detachably attached to the cartridge case.

[0021] Specifically, an electrode portion for transmitting electrical energy to the atomizer is embedded in the base.

[0022] As a preferred embodiment, the top of the cartridge case has a mist outlet nozzle extending upward, and there is at least one mist outlet nozzle.

[0023] Specifically, the inner side surface of the mist outlet nozzle is configured to be a cone that can gather the aerosol.

[0024] Specifically, the mist outlet nozzle and the atomizer are connected via a mist outlet pipe.

[0025] As an embodiment, the housing includes a cartridge case for receiving the cartridge assembly, and the cartridge assembly is detachably assembled in the cartridge case.

[0026] Specifically, an upper air inlet is configured at the bottom of the cartridge case, and the flow generator is communicated with the upper air inlet.

[0027] Specifically, a wind gathering hood for gathering and guiding the airflow into the ammunition assembly is arranged between the flow generator and the ammunition sleeve.

[0028] Specifically, the air collecting hood has an air outlet pipe extending into the ammunition sleeve, and the air outlet pipe is connected to the upper air inlet of the ammunition assembly.

[0029] Specifically, the air collecting hood has a conical inner cavity for collecting airflow.

[0030] Preferably, the atomizer is a heating atomizer or an ultrasonic atomizer. The heating atomizer is a ceramic core heating atomizer or a cotton core heating atomizer, and the ultrasonic atomizer is a piezoelectric ceramic atomizer or a mesh vibration atomizer.

[0031] Preferably, the flow generator is a fan or an air pump.

[0032] Preferably, the control unit includes a circuit board, which is vertically arranged in the gap between the cartridge case and the cartridge assembly. The housing has an operating portion, and the flow generator presses against the back of the circuit board to support the operating portion. The cartridge assembly is configured to output an aerosol flow rate of 1.0 to 50 ml / s, preferably 8 ml / s. The cartridge assembly is configured to output an aerosol for a duration of 0.2 to 5.0 seconds per shot, preferably 2.5 seconds per shot.

[0033] Preferably, an air inlet cavity is formed between the flow generator and the housing, and a battery is installed in the air inlet cavity. The battery is placed horizontally in the air inlet cavity.

[0034] The present invention also provides a method for controlling precise drug delivery of aerosols by positive pressure airflow, which is applicable to the above-mentioned precise delivery device, and the precise drug delivery control method comprises:

[0035] Controlling the operation of the drug cartridge assembly to set a time to generate drug aerosol;

[0036] The flow generator is controlled to generate a positive pressure airflow to discharge the aerosol out of the nebulization chamber.

[0037] Furthermore, the precise drug delivery control method further includes:

[0038] Obtaining an electronic prescription based on user information, wherein the electronic prescription includes aerosol administration duration, administration frequency, administration interval, administration intensity, and administration dosage;

[0039] The control unit controls the operation of the cartridge assembly and the flow generator according to the electronic prescription.

[0040] Specifically, the electronic prescription is formulated based on drug concentration, number of atomization times, atomization time, atomization power and user information.

[0041] Preferably, the drug cartridge assembly is configured to controllably output aerosolized particles with a particle size range of 20 nm to 20 μm to implement partial or full respiratory tract administration.

[0042] Preferably, the cartridge assembly is configured to be capable of controllably adjusting the output of the aerosol.

[0043] Preferably, the control unit comprises a dosage adjustment portion operable by a user to adjust the aerosol output amount.

[0044] Preferably, the drug cartridge assembly has an identification device for identifying drug information; the control unit is configured to obtain the drug information and set the mist flow rate and mist discharge time of the drug cartridge assembly according to the drug information.

[0045] Preferably, after the drug cartridge assembly is controlled to shut down the atomization operation, the control unit controls the flow generator to delay shutting down according to the set administration location, so as to generate incremental airflow to deliver the aerosol to the administration location in the respiratory tract. The delay of the flow generator is set to 0.1 to 5.0 seconds.

[0046] Due to the adoption of the above technical solution, the present invention has the following beneficial effects:

[0047] The precise drug delivery device of the present invention can actively deliver drug aerosols to the user's respiratory system in a targeted manner, which subversively solves the long-standing problem of aerosol inhalation drug administration, namely that the inhaled dose of the drug and the deposition position of the drug depend on the user's lung capacity, breathing force, inhalation technique and aerosol particle size. Active aerosol delivery solves the problem that some users, especially those with long-term lung diseases and the elderly and children, have weak breathing force and cannot generate enough breathing force to inhale the drug. It also solves the problem of self-administration of some drug users when they are in a powerless state due to overdose of drugs or when they have an emergency attack of diseases such as type I allergic reactions and have difficulty breathing, so as to achieve self-rescue. In addition, the delivery device has a compact structure and can be held in the hands of the user. Therefore, the aerosol delivery device has the advantages of being easy to carry and easy to use. Through active aerosol delivery, the present invention can achieve targeted deposition of drugs in part or all of the respiratory tract, significantly improve the efficacy of the drug, and reduce the side effects of the drug on the liver, etc.

[0048] The present invention can also realize intelligent and personalized aerosol drug delivery. The on-duty doctor or electronic doctor can formulate a personalized drug delivery method, that is, an electronic prescription, according to the user's personal situation, and then transmit the electronic prescription to the precision delivery device and store it. The control unit executes the drug delivery program according to the electronic prescription, thereby realizing personalized treatment for the user and significantly improving the optimal treatment effect of each user.

[0049] The present invention can achieve the goal of delivering precise doses of drugs to the user's treatment area, thereby achieving the purpose of precise treatment, improving the therapeutic effect of the drug, and reducing its toxic side effects. BRIEF DESCRIPTION OF THE DRAWINGS

[0050] In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the drawings of the embodiments will be briefly introduced below. Obviously, the drawings in the following description only relate to some embodiments of the present invention, but are not intended to limit the present invention.

[0051] FIG1 is a schematic structural diagram of the cover in the first embodiment.

[0052] FIG2 is a schematic structural diagram of the cover-opening state in the first embodiment.

[0053] FIG. 3 is an exploded view of FIG. 1 .

[0054] FIG4 is a cross-sectional view of the first embodiment.

[0055] FIG5 is a view of the internal structure of the first embodiment.

[0056] FIG6 is a schematic structural diagram of the drug cartridge assembly in Example 1.

[0057] FIG. 7 is a cross-sectional view of FIG. 6 .

[0058] FIG. 8 is an exploded view of FIG. 6 .

[0059] FIG9 is a diagram showing the distribution of aerosol particles output by the cartridge assembly.

[0060] Figure numerals: 1. Box cover; 2. Shell; 2a. Left shell; 2b. Right shell; 2c. Air inlet; 3. Indicator light; 4. Button; 5. Cartridge assembly; 5a. Cartridge shell; 5a1. Mist outlet nozzle; 5b. Liquid medicine holding part; 5c. Aerosol channel; 5d. Atomizer; 5e. Base; 6. Cartridge cover; 7. Wind gathering hood; 8. Flow generator; 9. Circuit board; 10. Battery. DETAILED DESCRIPTION

[0061] To make the objectives, technical solutions, and advantages of the embodiments of the present invention more apparent, the present invention will be further described in detail below with reference to the accompanying drawings. The components of the embodiments of the present invention generally described and illustrated in the accompanying drawings can be arranged and designed in a variety of different configurations. All other embodiments derived by persons of ordinary skill in the art based on the embodiments of the present invention without inventive effort are intended to fall within the scope of protection of the present invention.

[0062] It should be noted that similar reference numerals and letters denote similar items in the following drawings, and therefore, once an item is defined in one drawing, it does not need to be further defined or explained in subsequent drawings.

[0063] Unless otherwise defined, technical or scientific terms used in this patent document shall have the ordinary meanings understood by persons of ordinary skill in the art to which this invention belongs. The terms "first," "second," and similar expressions used in the specification and claims of this invention do not denote any order, quantity, or importance, but are merely used to distinguish one component from another. Similarly, terms such as "a," "an," or "the" do not denote a limitation of quantity, but rather denote the presence of at least one. Terms such as "include" or "comprising" mean that the elements or objects preceding the phrase "include" or "comprising" include the elements or objects listed after the phrase and their equivalents, and do not exclude other elements or objects. Terms such as "center," "upper," "lower," "left," "right," "vertical," "horizontal," "inner," and "outer" are used solely to indicate relative positional relationships. When the absolute position of the described object changes, the relative positional relationship may also change accordingly. These terms are used solely to facilitate the description of the invention and to simplify the description. They are not intended to indicate or imply that the device or component referred to must have, be constructed, or operate in a specific orientation, and are not to be construed as limitations on the invention.

[0064] In the description of the present invention, it should be noted that, unless otherwise expressly specified or limited, the terms "mounted," "connected," and "connected" should be understood in a broad sense. For example, they may refer to fixed, detachable, or integral connections; mechanical, electrical, or magnetic connections; direct, indirect, or internal communication between two components. Those skilled in the art will understand the specific meanings of the above terms in the present invention based on the specific circumstances.

[0065] The following describes some embodiments of the present invention in detail with reference to the accompanying drawings. In the absence of conflict, the features of the following embodiments can be combined with each other.

[0066] Example 1:

[0067] Referring to Figures 1-9, the present invention provides a precision drug delivery device for aerosol delivery, comprising a housing 2, a cartridge assembly 5, a flow generator 8, and a control unit. The housing 2 is sized and shaped to fit in the user's hand. The cartridge assembly 5 is capable of atomizing a set dose of drug into an aerosol, and the cartridge assembly 5 includes an aerosol passage 5c for transporting the aerosol. The flow generator 8 is configured to generate a positive pressure airflow to deliver the aerosol to the respiratory tract, which includes the mouth, nose, trachea, and lungs. The aerosol enters the trachea and lungs through the mouth and nose. The flow rate and velocity of this positive pressure airflow can be set and adjusted to precisely deliver the drug to the user, achieving targeted drug delivery and significantly improving drug utilization and therapeutic efficacy. The control unit is configured to receive user commands and drive the cartridge assembly 5 to discharge the drug aerosol, while simultaneously driving the flow generator 8 to generate a set amount of positive pressure airflow to drive the aerosol into the respiratory system. The cartridge assembly 5, flow generator 8, and control unit are all housed in the housing 2.

[0068] The above-mentioned precise delivery device can actively deliver drug aerosols to the user's respiratory system, which subversively solves the long-standing problems of aerosol inhalation drug administration, that is, the inhaled dose of the drug and the deposition position of the drug depend on the user's lung capacity, breathing strength, inhalation skills and aerosol particle size, and active aerosol delivery drug administration solves the problem that some users, especially long-term lung disease users and elderly and children, have weak breathing strength and cannot produce enough breathing force to inhale drugs. It also solves the problem that some drug users are in a powerless state (for example, in a state of shock) due to excessive drug use or when an emergency attack of a disease such as type I allergic reaction causes difficulty in breathing, and autonomous drug administration is used to achieve self-help problems. In addition, the delivery device has a compact structure and can be held in the hands of the user. Therefore, the aerosol delivery device has the advantages of being easy to carry and easy to use, and does not require hospitalization, saves medical resources, and significantly improves the compliance of the user. Through active precise atomization and precise delivery drug administration, the present invention can achieve partial or full respiratory tract targeted deposition of drugs, reducing the damage caused by drugs to non-lesion sites.

[0069] As shown in Figures 6 to 8, described drug cartridge assembly 5 comprises drug cartridge case 5a and atomizer 5d, and the inside of drug cartridge case 5a limits the medicine storage bin, and atomizer 5d is positioned in described drug cartridge case 5a with atomized medicine.In the present embodiment, medicine is packed in the medicine storage bin with solid or liquid form, specifically can be that medicine and solid auxiliary material are mixed and made into solid preparation (only applicable heating atomization) or dissolved in solvent and made atomized medicinal liquid, then be filled in the medicine storage bin, or install medicinal liquid holding portion 5b in the medicine storage bin, for example, liquid-absorbing porous materials such as cotton wick, porous ceramics, adsorbent.In order to prevent that medicinal liquid from losing efficacy for a long time, medicine and atomized solvent can be separately packaged, evacuate isolation membrane when in use, dissolve medicine in the atomized solvent, thereby prolong the service life of medicine.

[0070] As shown in Figure 7, to facilitate the addition of liquid medicine or dissolving the medicine into the solution, a base 5e is attached to the bottom of the medicine shell 5a in this embodiment. The base 5e and the medicine shell 5a together define the medicine storage compartment. Specifically, the base 5e is a rubber or silicone member. The base 5e is detachably attached to the medicine shell 5a and can be inserted into the opening at the bottom of the medicine shell 5a to block the opening and provide a sealing effect to prevent liquid medicine leakage. In another embodiment, the base 5e and the medicine shell 5a can be configured as a single body, or welded or fixed together in a subsequent process. This structure has better sealing than a split structure, but does not allow the user to replace the liquid medicine and can only be discarded after use. The cost of use is relatively high, but it does not cause cross infection.

[0071] Since the atomizer 5d is provided in the cartridge case 5a, in order to supply power to the atomizer 5d, an electrode portion for transmitting power to the atomizer 5d is embedded in the base 5e. Specifically, there are two electrode portions, which are metal parts or other conductive objects embedded in the base 5e.

[0072] As shown in Figures 6-8, the top of the drug cartridge 5a has a mist outlet nozzle 5a1 extending upward, and there is at least one mist outlet nozzle 5a1. Specifically, in this embodiment, there are two mist outlet nozzles 5a1, one on each side, each engaging a nostril. Therefore, the aerosol precision delivery device in this embodiment primarily delivers drugs through the nose, inducing the central nervous system through the nasal mucosa and olfactory bulb to treat emotional and mental illnesses. The delivery device of the present invention can actively deliver drugs according to the user's needs, solving the problem that some users lack sufficient breathing strength to actively inhale the appropriate dose of drugs and control the location of drug deposition. For example, users who have overdosed on drugs are often in a state of confusion, with clenched teeth and weak breathing. This makes it impossible to take oral or injection medications, nor can they use emergency medications by active inhalation, thus losing valuable opportunities for treatment. The aerosol precision delivery device in this embodiment achieves precise and timely treatment for users or self-help through active targeted drug delivery (active administration of antidotes through the nasal cavity and respiratory tract). The awakening of anesthetized patients after surgery can usually only be done by injecting drugs; or when an emergency attack of type I allergic reaction causes breathing difficulties, patients usually implement self-rescue by injecting spare drugs. The aerosol precision delivery device in this embodiment can completely replace injection drug administration through active nasal and respiratory tract administration. The outlet diameter D of the mist outlet nozzle 5a1 is 1.0mm≤D≤3.5mm. The mist outlet nozzle 5a1 within this diameter range can achieve a balance between the amount of mist and the speed of mist, avoiding the problem of trapped air caused by the mist outlet nozzle 5a1 being too small. When the mist outlet nozzle 5a1 is larger, the force of the mist outlet is insufficient and the drug cannot be effectively delivered to the user. At the same time, the above diameter setting can also ensure that the mist outlet nozzle 5a1 fits the nasal cavity, improving the comfort of use. Specifically, the diameter D of the mist outlet nozzle 5a1 is 2.5mm, and can also be any value in the range of 1.0mm≤D≤3.5mm. The inner side surface of the mist outlet nozzle 5a1 is configured to be a cone that can gather the aerosol so as to fit the nostril, prevent leakage, and improve the accuracy of aerosol delivery.

[0073] As shown in Figures 6 and 7, the mist outlet nozzle 5a1 and the atomizer 5d are connected via a mist outlet pipe. The function of the mist outlet pipe is to guide the generated aerosol upward to the mist outlet nozzle 5a1 to prevent air entrapment. Specifically, a pipe can be connected to the atomizer 5d, and the generated aerosol can flow into the mist outlet nozzle 5a1 through the mist outlet pipe. Specifically, the mist outlet pipe is a metal tube that extends from the top of the atomizer 5d to the bottom of the mist outlet nozzle 5a1. In the present invention, the above-mentioned air entrapment refers to the fact that the outlet flow rate is less than the aerosol output flow rate, resulting in the aerosol being unable to flow out effectively, and it seems to be trapped in the aerosol channel 5c, which reduces the delivery accuracy.

[0074] In this embodiment, the housing 2 includes a cartridge case 6 for receiving the cartridge assembly 5. The cartridge assembly 5 is detachably assembled in the cartridge case 6 to facilitate user replacement of the cartridge assembly 5. For users, convenient replacement of the cartridge assembly 5 is very important. Users can use the same body to replace cartridges containing different drugs for aerosolized drug delivery, thereby reducing usage costs.

[0075] It should be noted that the atomizer 5d in the present invention is a heating atomizer or an ultrasonic atomizer. For drugs with excellent thermal stability, the solid preparation of the drug can be directly heated or prepared into a liquid atomizer and then heated to evaporate and atomize into an aerosol. Since some drugs are unstable under high temperature conditions and easily decompose and become ineffective, ultrasonic atomizers are more advantageous than heating atomizers for thermally unstable drugs. The heating atomizer is a heating element (solid atomizer), a ceramic core or a cotton core heating atomizer (liquid atomizer). Similar heating atomization methods have been widely used in the electronic cigarette industry; the ultrasonic atomizer is a piezoelectric ceramic atomizer or a mesh atomizer. Ultrasonic atomization is also a conventional atomization method, widely used in the medical and beauty industries, and its specific structure will not be described in detail. Furthermore, the flow generator 8 in the application is a fan or an air pump. The fan is preferably a fan with adjustable air volume and wind speed. The air pump can be a micro air pump produced by Murata Manufacturing Co., Ltd. of Japan, and its flow rate can be adjusted by changing the current value. Specifically, in this embodiment, the flow generator 8 is a fan. It should be further explained that, in order to introduce the drug liquid into the nebulizer 5d for atomization, for a heating type nebulizer 5d, a liquid guide is usually provided around the nebulizer 5d to guide the drug liquid to the periphery of the nebulizer 5d. When heated, the drug liquid in the liquid guide is directly atomized into an aerosol. The liquid guide is usually made of a porous temperature-resistant material, such as ceramic, cotton fiber, etc.

[0076] To ensure rapid aerosol discharge from the mist outlet nozzle 5a1, an upper air inlet is provided at the bottom of the cartridge case 6 in this embodiment. The fan's air outlet is connected to the upper air inlet, allowing the fan-generated airflow to enter the cartridge assembly 5 through the upper air inlet. A wind collector 7 is provided between the flow generator 8 and the cartridge case 6 to gather and guide the airflow into the cartridge assembly 5. The wind collector 7 includes an air outlet pipe extending into the cartridge case 6 and docking with the upper air inlet of the cartridge assembly 5. In another embodiment, to more efficiently guide the fan-generated airflow into the cartridge assembly 5, the wind collector 7 includes a conical inner cavity for concentrating the airflow. Specifically, the inner cavity of the wind collector 7 is designed to be conical, allowing the airflow to be gathered and then enter the cartridge assembly 5 through the top of the conical inner cavity.

[0077] As shown in Figures 3 and 5, the control unit includes a circuit board 9, on which are disposed an indicator light 3 and a button 4. To save space, the circuit board 9 is vertically arranged in the gap between the cartridge case 5a and the housing 2. This configuration significantly reduces the overall size of the device, making it easy to hold and operate. The housing 2 incorporates a user-pressable operating portion, with the fan and cartridge case 5a pressing against the back of the circuit board 9 to support the operating portion, thereby simplifying installation and conserving internal space. To prevent accidental activation and wasteful use, such as when the device is placed in a pocket, handbag, or backpack, where objects may be squeezed against each other and trigger atomization, resulting in waste and potentially contaminating other items, the surface of the button 4 in this embodiment is flush with or slightly lower than the outer surface of the housing 2.

[0078] To further reduce the overall size of the product, the present invention places the battery 10 horizontally within the air intake chamber. Specifically, an air intake chamber is formed between the fan and the housing 2, within which the battery 10 is installed. To facilitate installation of the internal components, the housing 2 is divided into a left shell 2a and a right shell 2b. The top of the housing 2 has an opening. The ammunition sleeve 6 is clamped between the left and right shells 2a, 2b, and the ammunition assembly 5 is slidably mounted within the sleeve 6. Figure 5 shows the internal structure after the left shell 2a is removed. The left and right shells 2a, 2b can be secured together using fasteners such as screws or snaps. An air intake hole 2c is provided in the right shell 2b. Furthermore, a lid 1 is attached to the top of the housing 2. The lid 1 is pivotally connected to the housing 2 and can be opened and closed by flipping the lid 1, providing convenient and hygienic use.

[0079] Example 2:

[0080] Referring to Figures 1 to 8 above, the present invention further provides a method for controlling precise drug delivery of aerosols via positive pressure airflow, which is applicable to the precise delivery device described above. The precise drug delivery control method includes:

[0081] Controlling the operation of the drug cartridge assembly 5 to set a time to generate drug aerosol;

[0082] The fan is controlled to generate a positive pressure airflow to discharge the aerosol out of the nebulization chamber.

[0083] Preferably, the drug cartridge assembly 5 can be controlled to operate for a set time to generate a drug aerosol. Subsequently, the fan can be further controlled to generate a positive pressure airflow to expel the aerosol from the nebulizer chamber and into the respiratory tract. Specifically, in this embodiment, the set time is 2.5 seconds, but other time values ​​between 0.2 and 5 seconds, such as 1 second, 2 seconds, or 3.5 seconds, can also be selected. Persons skilled in the art can select an appropriate set time after thorough laboratory verification. The nebulizer 5d is a heated nebulizer 5d, which first generates the aerosol and then generates an airflow to expel the aerosol. This prevents the airflow from lowering the temperature of the nebulizer 5d and thereby affecting the aerosolization effect. In another embodiment, the drug cartridge assembly 5 and the fan can also be controlled to operate simultaneously, that is, the airflow and aerosol are generated simultaneously. In this embodiment, to achieve precise drug delivery, the aerosol dosage can be controlled by the operating time and power of the nebulizer 5d, while the air volume and speed can be controlled to precisely deliver the drug to the desired deposition site in the respiratory tract, achieving targeted drug delivery.

[0084] Furthermore, the precise drug delivery control method further includes: obtaining an electronic prescription set by a doctor based on user information, the electronic prescription including the time of atomization drug delivery, the frequency of drug delivery, the interval between drug delivery, the intensity of drug delivery, and the dosage of drug delivery; and the control unit controlling the operation of the drug cartridge assembly 5 and the flow generator 8 based on the electronic prescription. Specifically, the electronic prescription is formulated based on the drug concentration, the number of atomizations, the interval between atomizations, the duration of atomization, the power of atomization, and the user's personalized information, thereby enabling intelligent, precise, and personalized targeted drug delivery. The above-mentioned user information may include the user's disease diagnosis and treatment history, drug allergy history, health constitution information, and genetic information. Precise drug delivery based on user information can better identify and treat symptoms and achieve the best treatment effect.

[0085] The precise atomization device involved in this invention is used to atomize and deliver medications at each dose, which is equivalent to the pulse theory in electromagnetism, and the present invention borrows its terminology. The precise pulse atomization drug delivery parameters include pulse length (pulse peak width), number (pulse frequency), interval (pulse period), amplitude (pulse peak height), and energy (pulse peak area), which are set to correspond to the corresponding atomization parameters in the precise drug delivery "electronic prescription": atomization duration, drug delivery frequency, drug delivery interval, drug delivery intensity, and drug delivery dosage.

[0086] The starting time node of the applied pulse, pulse time (width), pulse frequency (number of times), pulse interval (period), pulse amplitude (peak height) and pulse energy (peak area) can be synchronized with the user's inhalation start time, inhalation length, number of puffs, interval between each puff, inhalation strength and inhalation dose. The time node, length, number of times, interval, strength and dose of drug administration can also be set in advance by manual buttons or programs to implement precise drug administration with time and quantity.

[0087] (a) Pulse cycles can be divided into long and short cycles. For example, if medication is taken an average of three times a day, each dose requires five deliveries or five inhalations (five pulse doses), each lasting 2.5 minutes. Thus, the long cycle is approximately 24 / 3 = 8 hours, and the short cycle is approximately 2.5 / 5 = 0.5 minutes (i.e., 30 seconds).

[0088] (b) Drug dosage includes: (1) the dosage of each pulse of nebulized liquid and the dosage of active drug contained therein (pulse dosage); (2) the total dosage of nebulized liquid and the total dosage of active drug contained therein for each medication administration (the cumulative total amount of multiple pulse administrations each time); and (3) the total dosage of nebulized liquid and the total dosage of active drug contained therein for each medication administration (the cumulative total amount of multiple administrations per day).

[0089] (c) These parameters can be used by the intelligent "electronic doctor" to compile a "tailored" drug administration "electronic prescription" program based on the drug concentration, number of atomizations, atomization duration, atomization timing, output power and user's individual conditions, and then be implanted into the user's atomization device to determine the user's medication time node, number of deliveries, pulse dose per time, total number of pulses and total dose per medication, total number of inhalations and total dose per day;

[0090] (d) The user strictly follows the procedure set by the "electronic prescription" to take the medicine. The chip program immediately records the medication situation and treatment effect, and the data is immediately fed back to the "electronic doctor" and "electronic medical record" files; the "electronic doctor" remotely monitors the user's medication situation and treatment effect, and can modify the medication parameters at any time, adjust the "electronic prescription", and the atomizer controls the medication program according to the latest instructions; at the same time, the atomizer or the cloud establishes the user's "electronic medical record" file, receives and stores the user's immediate medication situation, treatment effect and various adverse reactions, etc., and promptly feeds back to the "electronic doctor".

[0091] (e) Completely different from the fixed specifications (dosages) of tablets, capsules, patches and injections, in theory, intelligent atomization drug delivery can adjust the atomization nodes, atomization duration, atomization times, atomization duration and atomization dose at any time by modifying the program, dynamically changing the drug dosage "specifications" and the number of medications, so that the dose can be accurately and infinitely divided, always keeping the user's blood drug concentration at the best state and achieving the best therapeutic effect.

[0092] (f) The intelligent "electronic doctor" can issue dynamic and personalized "electronic prescriptions" based on the user's genetic information, race, gender, age, weight, height, medical history and the latest collected inspection, test and medication feedback data in the "electronic medical record" file. After receiving the new "electronic prescription", the intelligent atomization device strictly implements the program atomization drug delivery to achieve the goal of program-controlled digital drug delivery. At the same time, it continuously collects medication and efficacy data and feeds it back to the "electronic doctor" and continuously enriches the "electronic medical record" file data, forming a dynamic closed loop.

[0093] This invention successfully incorporates the concept of pulses from electromagnetic theory, organically linking parameters such as pulse duration (peak width), frequency (frequency), interval (period), amplitude (peak height), and energy (peak area) with parameters such as aerosol drug delivery duration, frequency, interval, intensity, and dosage. This has led to the concept of an "electronic doctor," and further to the concepts of "electronic prescriptions" and "electronic medical records." Defining these fundamental parameters, combined with the precise and infinite divisibility of aerosolized liquid and the instantaneous variability of the "specifications" of liquid aerosols, lays a solid foundation for intelligent, precise, and personalized drug delivery.

[0094] Before the emergence of intelligent "electronic doctors," smart nebulizer inhalation devices can utilize electronic monitoring systems connected to the internet or other devices. Through external or integrated means, these devices can improve medication compliance and reduce medication errors caused by the device or operator, particularly for controlled medications. External intelligent systems with comprehensive monitoring and feedback capabilities can record user medication information, enabling data sharing between doctors and patients, allowing doctors to adjust treatment plans in a timely manner. In addition to providing reminders, recording, and management functions, information can also be uploaded to a mobile phone via Bluetooth. The integrated smart nebulizer 5D uses adaptive nebulization delivery technology, analyzing the user's breathing pattern to determine the atomization time of the nebulized medication during inhalation.

[0095] Furthermore, to achieve precise drug delivery, the drug cartridge assembly 5 of the present invention is configured to controllably output aerosolized particles with a particle size range of 20 nm to 20 μm. Aerosols of varying particle sizes are deposited in corresponding respiratory tract locations, enabling targeted drug delivery to a portion or the entire respiratory tract. The respiratory tract is divided into upper and lower sections: the nose, pharynx, and larynx are collectively referred to as the upper respiratory tract. The trachea, bronchi, and lungs are collectively referred to as the lower respiratory tract, or tracheal tree. The applicant's research has shown that aerosolized particles of varying sizes deposit at different locations within the respiratory tract. By carefully controlling the aerosolized particle size, drug delivery can be targeted to different respiratory tract locations, achieving precise drug delivery. For heated cotton-wick nebulizers 5d, the aerosolized particle size can be adjusted by controlling the viscosity of the aerosol, the power of the heating element, and the airflow rate. For ceramic-core nebulizers 5d, the aerosolized particle size can be adjusted by controlling the viscosity of the aerosolized agent, the size of the porous ceramic pores, the power of the heating element, and the airflow rate. However, for ultrasonic atomizers, the aerosol particle size must be controlled by passing the aerosol through a mesh screen. Figure 9 shows the distribution of aerosol particles output by the drug cartridge assembly 5, measured using specialized instrumentation. As shown in Figure 9, the bar graph represents the probability of aerosol appearing within different particle size ranges, while the wavy lines represent the percentage of aerosol within each size range. The graph shows that the aerosolized particles generated by the atomizer in this example generally range in size from 1 to 10 μm, with the aerosol amount within this range approaching 100% and exhibiting a roughly normal distribution. Furthermore, the proportion of aerosol particles within the 1 to 5 μm size range is approximately 60%, ensuring not only the stability of the particle size output but also the ability of aerosolized particles within this size range to deposit in the patient's lungs, thereby achieving precise drug delivery and improving the effectiveness of drug therapy. It should be noted that the specialized instrumentation described above can be a PSA series laser particle size analyzer manufactured by Anton Paar, which utilizes dynamic light scattering (DLS) for measurement. Dynamic light scattering (DLS) is a physical technique used to characterize the size of particles and molecules in suspensions or solutions.

[0096] In addition, the drug cartridge assembly 5 is configured to be able to controllably adjust the aerosol output. Specifically, the aerosol output can be adjusted by controlling the power of the nebulizer 5d, the atomization duration, and the fan air volume. The drug cartridge assembly 5 is configured so that the aerosol output flow rate is 1.0 to 50 ml / s, preferably 8 ml / s. The output adjustment can be programmed based on the electronic prescription described above, or manually adjusted based on the user's actual drug demand. An adjustment device, such as a knob or screen, can be provided on the product for the user to adjust the aerosol output. That is, the control unit includes a dosage adjustment unit that can be used to operably adjust the aerosol output.

[0097] Furthermore, for precise drug delivery, an identification device for identifying drug delivery information can be provided on the drug cartridge assembly 5, and the control unit can be configured to obtain the drug delivery information and set the mist output volume / second and mist output duration of the drug cartridge assembly 5 based on the drug delivery information. For example, the identification device is an RFID, NFC, or barcode, etc., and the drug delivery information is written into the identification device. The control unit has a corresponding reading device to read the above drug delivery information, thereby controlling the mist output volume / second and mist output duration of the drug cartridge assembly 5 based on the drug delivery information. The above control can also be combined with an electronic prescription to achieve more precise drug delivery.

[0098] It should be noted that after the controlled closure of the drug cartridge assembly 5, the control unit controls the flow generator 8 to delay closure based on the set administration location, generating incremental airflow to deliver the aerosol to the administration location in the respiratory tract. The delay time ranges from 0.1 to 5.0 seconds, specifically 0.2 seconds, 0.3 seconds, 0.5 seconds, etc., and can be set based on the targeted administration location. Within a certain time range, a longer operating time of the flow generator 8 can deliver the aerosol deeper into the respiratory tract.

[0099] The above-mentioned precise drug delivery method can also be implemented in the following manner.

[0100] (1) The atomizing device (cartridge assembly + flow generator + control unit) is configured to produce 100 pulses per gram of atomized liquid (100 pulses / gram of atomized liquid);

[0101] (2) Set the atomization time to 2.5 seconds (i.e., pulse width = 2.5 seconds);

[0102] (3) The fan air supply lasts for 3.0 seconds (with a 0.5 second delay), with an air supply rate of 8 mL / second. The total volume delivered to the mouth / nose each time = (2.5 x 8) + (0.5 x 8) = 24 mL. The first 20 mL of air supply and atomization occur simultaneously, while the last 4 mL of air supply only delivers the remaining aerosol in the airway to the mouth / nose;

[0103] (4) If the drug is administered through the nasal cavity, the 24 ml of aerosol delivered will just fill the entire nasal cavity (the average volume of the nasal cavity = 24 ml). At this time, the two aerosol outlets are tightly attached to the two nostrils without any gap and the breath is held for 5-10 seconds. The aerosol is deposited on the nasal mucosa, and there is no need to spray the left and right nostrils separately;

[0104] (5) If atomization and air supply are started simultaneously through oral inhalation (with a microphone or air-sensitive switch installed), the 24 mL aerosol can be delivered to the oral cavity and then inhaled or air supplied (i.e., the inhalation / air supply time is ≥ 3.0 seconds). After that, the breath is held for 5-10 seconds. The aerosol will be deposited in different lesion sites of the oral cavity, throat, upper respiratory tract, and lower respiratory tract. The specific deposition site depends on the inhalation / air supply time and the length of the air supply delay.

[0105] (6) The dose of aerosol liquid per pulse is 10 mg (i.e., 100 pulses / g of aerosol liquid is set);

[0106] (7) N pulses were administered each time, with a pulse interval of 30 seconds (i.e., the pulse short period was set to 30 seconds, N = 1-20);

[0107] (8) Administer M doses per day (i.e., set pulse length = 24 / M hours);

[0108] (9) The dose of nebulized liquid per pulse = 10 mg / pulse, the total dose of nebulized liquid per administration = N x 10 mg, and the total dose of nebulized liquid per day = M x N x 10 mg;

[0109] (10) If the drug concentration of the nebulized liquid = X%, the active drug dose of each pulse administration = 10 mg x X%, the total active drug dose of each administration = N x 10 mg x X%, and the total active drug dose of each day = M x N x 10 mg x X%.

[0110] 1.0 g (100 pulses) of the above-mentioned drug aerosol (10%) was loaded into the drug cartridge storage chamber of the "heating atomization (ceramic core)" or "ultrasonic atomization (mesh vibration)" device of the present invention. A control unit was programmed to administer pulsed nasal / oral inhalation three times a day, five pulses each time, with each atomization duration of 2.5 seconds and one atomization every 30 seconds (2 pulses / minute); the inhaled dose was 10 mg / pulse; the fan supply duration was 3.0 seconds (with a 0.5 second delay) and the air supply rate was 8 mL / second.

[0111] Corresponding electronic prescription parameters: number of pulses per day = 3x5, pulse width 2.5 seconds, short cycle = 30 seconds, long cycle I = 24 / 3 hours (not considering sleeping time interval); nebulized liquid dose per inhalation = 10 mg / pulse, total nebulized liquid dose per time = 5x10 mg / time, total nebulized liquid dose per day = 3x5x10 mg / day; active drug dose per inhalation = 10 mgx10% / pulse, total active drug dose per time = 5x10 mgx10% / time, total active drug dose per day = 3x5x10 mgx10% / day.

[0112] The atomization electronic prescription parameters (drug cartridge administration information) are input or read into the control unit. The atomization device will strictly follow the set electronic prescription, promptly remind the patient of the medication time, accurately provide the drug dosage for each pulse, the number of pulses for each inhalation, and the number of inhalations per day, and perform intelligent, precise, and personalized atomization administration.

[0113] The above description is merely a specific embodiment of the present invention, but the scope of protection of the present invention is not limited thereto. Any changes or substitutions that can be easily conceived by a person skilled in the art within the technical scope disclosed in the present invention should be included in the scope of protection of the present invention. Therefore, the scope of protection of the present invention should be based on the scope of protection of the claims.

Claims

1. A precision delivery device for delivering drug aerosol, characterized in that: It includes: a housing sized and shaped to be held in a hand of a user; A drug cartridge assembly, which can atomize a set dose of a drug into an aerosol, and the drug cartridge assembly has an aerosol channel for conveying the aerosol; a flow generator for generating a positive pressure airflow for delivering the aerosol to the respiratory tract; as well as A control unit, which drives the drug cartridge assembly to output drug aerosol according to an operation instruction, and drives the flow generator to generate a set amount of positive pressure airflow; Wherein, the ammunition assembly, the flow generator and the control unit are all received in the housing.

2. The precise delivery device according to claim 1, characterized in that: The ammunition assembly comprises: A drug cartridge case, the interior of which defines a drug storage compartment; and A nebulizer is positioned in the drug cartridge to aerosolize the drug.

3. The precise delivery device according to claim 2, characterized in that: A base is attached to the bottom of the drug cartridge case, and the base and the drug cartridge case together define the drug storage bin.

4. The precise delivery device according to claim 3, characterized in that: The base is detachably attached to the cartridge case.

5. The precise delivery device according to claim 3 or 4, characterized in that: An electrode part for transmitting electric energy to the atomizer is embedded in the base.

6. The precise delivery device according to claim 2, characterized in that: The top of the drug cartridge case is provided with a mist outlet nozzle extending upward, and there is at least one mist outlet nozzle.

7. The precise delivery device according to claim 6, characterized in that: The inner side surface of the mist outlet nozzle is configured to be a cone that can gather the aerosol.

8. The precise delivery device according to claim 6, characterized in that: The mist outlet nozzle and the atomizer are communicated with each other via an aerosol passage.

9. The precise delivery device according to claim 1 or 2, characterized in that: The housing includes a cartridge case for receiving the cartridge assembly, wherein the cartridge assembly is detachably assembled in the cartridge case.

10. The precise delivery device according to claim 9, characterized in that: An upper air inlet is arranged at the bottom of the cartridge case, and the flow generator is communicated with the upper air inlet.

11. The precise delivery device according to claim 10, characterized in that: A wind gathering hood for gathering and guiding the airflow into the ammunition assembly is arranged between the flow generator and the ammunition shell.

12. The precise delivery device according to claim 11, characterized in that: The air gathering hood has an air outlet pipe extending into the ammunition shell, and the air outlet pipe is connected to the upper air inlet of the ammunition shell assembly.

13. The precise delivery device according to claim 11 or 12, characterized in that: The wind gathering hood has a conical inner cavity for gathering airflow.

14. The precise delivery device according to claim 2, characterized in that: The atomizer is a heating atomizer or an ultrasonic atomizer.

15. The precise delivery device according to claim 2, characterized in that: The heating atomizer is a ceramic core heating atomizer or a cotton core heating atomizer, and the ultrasonic atomizer is a piezoelectric ceramic atomizer or a mesh vibration atomizer.

16. The precise delivery device according to claim 1, characterized in that: The flow generator is a fan or an air pump.

17. The precise delivery device according to claim 1, characterized in that: The control unit includes a circuit board, which is vertically arranged in a gap between the housing and the ammunition assembly.

18. The precise delivery device according to claim 17, characterized in that: The housing has an operating portion, and the flow generator is pressed against the back surface of the circuit board to support the operating portion.

19. The precise delivery device according to claim 1, characterized in that: The drug cartridge assembly is configured such that the output flow rate of the aerosol is 1.0 to 50 ml / s, and preferably, the output flow rate of the aerosol is 8 ml / s.

20. The precise delivery device according to claim 19, characterized in that: The drug cartridge assembly is configured such that the aerosol output duration is 0.2 to 5.0 s / time, and preferably, the aerosol output duration is 2.5 s / time.

21. The precise delivery device according to claim 1, characterized in that: An air inlet cavity is formed between the flow generator and the shell, and a battery is installed in the air inlet cavity.

22. The precise delivery device according to claim 21, characterized in that: The battery is placed horizontally in the air inlet cavity.

23. The precise delivery device according to claim 1, characterized in that: The set amount of the positive pressure airflow includes flow rate and duration.

24. A method for controlling precise drug delivery of aerosols by positive pressure airflow, applicable to the precise delivery device according to any one of claims 1 to 23, characterized in that: The precise drug delivery control method comprises: Controlling the operation of the drug cartridge assembly to set a time to generate aerosol of the drug; The flow generator is controlled to operate so as to generate a set amount of positive pressure airflow to discharge the aerosol from the aerosol channel.

25. The precise drug delivery control method according to claim 24, characterized in that: Also includes: Obtaining an electronic prescription based on user information, wherein the electronic prescription includes aerosol administration duration, administration frequency, administration interval, administration intensity, and administration dosage; The control unit controls the operation of the cartridge assembly and the flow generator according to the electronic prescription.

26. The precise drug delivery control method according to claim 25, characterized in that: The electronic prescription is formulated based on drug concentration, number of atomization times, atomization time, atomization power and user information.

27. The precise drug delivery control method according to claim 26, characterized in that: The drug cartridge assembly is configured to controllably output aerosolized particles with a particle size range of 20 nm to 20 μm to implement partial or full respiratory tract drug administration.

28. The precise drug delivery control method according to claim 24, characterized in that: The cartridge assembly is configured so that it can controllably adjust the output dose of the aerosol.

29. The precise drug delivery control method according to claim 28, characterized in that: The control unit includes a dosage adjustment portion operable by a user to adjust the aerosol output amount.

30. The precise drug delivery control method according to claim 28, characterized in that: The drug cartridge assembly is provided with a marking device for marking drug information; The control unit is configured to obtain the drug information and set the mist flow rate and mist discharge time of the drug cartridge assembly according to the drug information.

31. The precise drug delivery control method according to claim 24, characterized in that: After the drug cartridge assembly is controlled to shut down the atomization operation, the control unit controls the flow generator to be closed with a delay according to the set administration position, so as to generate an incremental airflow to deliver the aerosol to the administration position in the respiratory tract.

32. The precise drug delivery control method according to claim 31, characterized in that: The delay of the flow generator is set to 0.1-5.0 s.

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