Mist generator

Abstract

To provide mist generator devices.SOLUTION: A mist generator device is used with a driver device, and comprises a mist generator housing, a liquid chamber, a sonication chamber, a capillary element, an ultrasonic transducer, and an airflow arrangement.SELECTED DRAWING: Figure 13

Description

[Technical Field]

[0001] Cross-reference to related applications This application asserts the benefit of each priority claim and incorporates them in their entirety by reference: U.S. Patent Application No. 17 / 122025, filed December 15, 2020, and U.S. Patent Application No. 17 / 220189, filed April 1, 2021.

[0002] The present invention relates to a mist inhaler. More particularly, the present invention relates to an ultrasonic mist inhaler for atomizing a liquid containing a therapeutic agent for inhalation by a user. [Background technology]

[0003] Mist inhalers are used to generate mist or vapor for the user to inhale. The mist may contain therapeutic drugs, medications, or pharmaceuticals that the user inhales and absorbs into the user's bloodstream.

[0004] Therapeutic aerosol delivery has become a mainstream treatment for asthma, chronic obstructive pulmonary disease (COPD), and cystic fibrosis. Therapeutic aerosols are also being used in the treatment of influenza and osteoporosis, as well as in vaccine delivery.

[0005] The delivery of therapeutic drugs to the lungs for the treatment of non-respiratory systemic diseases is attractive due to its high pulmonary vascularity, thin blood-alveolar barrier, large surface area, avoidance of gastric enzymes, and hepatic first-pass metabolism. Improved patient comfort and medication adherence are also attractive. The pulmonary system can be utilized for the delivery of antibodies, proteins, analgesics, and nucleic acids. The treatment of central nervous system disorders such as tobacco addiction could be significantly improved by efficiently delivering nicotine into the systemic circulation through the lungs.

[0006] The effectiveness of therapeutic aerosols depends on the amount of drug deposited beyond the oral-pharyngeal region. The area over which deposition occurs is a function of the size of the inhaled particles.

[0007] Currently, devices used for administering inhaled medications are classified into three types: nebulizers, metered-dose inhalers, and dry powder inhalers. Nebulizers are generally divided into two types: jet and ultrasonic, but conventional devices of both types had weaknesses and problems.

[0008] Jet nebulizers are based on the Bernoulli principle and produce relatively large droplets, which generally deposit in the oral cavity and pharynx, making them less effective. Ultrasonic nebulizers use piezoelectric crystals that vibrate at frequencies between 1 MHz and 1.7 MHz, transferring vibrational energy to the liquid to convert it into an aerosol. Ultrasonic nebulizers are not effective when viscous suspensions or solutions are used, as they tend to heat the drug, thus destroying the molecules and negating the benefits of inhalation.

[0009] Therefore, there is a need in the art for an improved mist inhaler that attempts to address at least some of the problems described herein. [Overview of the Initiative]

[0010] The present invention provides a mist inhaler as described in claim 1. The present invention also provides preferred embodiments as described in the dependent claims.

[0011] The various examples of this disclosure described below offer several advantages and benefits compared to conventional mist inhalers. These advantages and benefits are described below.

[0012] Because the mist inhaler in the example of the present disclosure is capable of more efficient operation than conventional mist inhalers, the mist inhaler in the example of the present disclosure has environmental benefits due to reduced power consumption.

[0013] According to one embodiment, a mist inhaler is provided for generating a mist for inhalation by a user, and the device comprises the following: A mist generator that includes the following: A long, slender mist generator housing equipped with an air inlet port and a mist outlet port. A liquid chamber provided within a mist generator housing, for containing the liquid to be atomized. Ultrasonic processing chamber located inside the mist generator housing A capillary element extending between a liquid chamber and an ultrasonic treatment chamber, wherein a first portion of the capillary element is located in the liquid chamber and a second portion of the capillary element is located in the ultrasonic treatment chamber. An ultrasonic transducer having a generally planar atomizing surface provided within an ultrasonic processing chamber, wherein the ultrasonic transducer is mounted within a mist generator housing such that the plane of the atomizing surface is substantially parallel to the longitudinal length of the mist generator housing. An ultrasonic processing apparatus according to claim 1, characterized in that a portion of the second part of the capillary element overlaps a portion of the atomizing surface, and the ultrasonic transducer is configured to vibrate the atomizing surface to atomize the liquid carried by the second part of the capillary element, thereby generating a mist consisting of the atomized liquid and air within the ultrasonic processing chamber. An airflow configuration that provides an air passage between an air inlet port, an ultrasonic processing chamber and a front air outlet port, wherein the user draws air from the mist outlet port through the inlet port, passes through the ultrasonic processing chamber and exits through the mist outlet port, and the mist generated in the ultrasonic processing chamber is carried by air through the mist outlet port for inhalation by the user, further comprising: Driver device containing the following: battery An AC driver that converts the voltage from the battery into an AC drive signal of a predetermined frequency to drive the ultrasonic transducer. An active power monitoring arrangement for monitoring the active power used by an ultrasonic transducer when the ultrasonic transducer is driven by an AC drive signal, the arrangement providing a monitoring signal indicating the active power used by the ultrasonic transducer. A processor for controlling an AC driver and receiving monitoring signal driving from an active power monitoring arrangement A memory storing instructions that, when executed by the processor, cause the processor to perform the following: A. Control the AC driver to output an AC drive signal to the ultrasonic transducer at a predetermined sweep frequency B. Calculate the active power being used by the ultrasonic transducer based on the monitoring signal C. Control the AC driver to modulate the AC drive signal to maximize the active power used by the ultrasonic transducer D. Save in the memory a record of the maximum active power used by the ultrasonic transducer and the sweep frequency of the AC drive signal E. After a predetermined number of iterations, repeat steps A - D a predetermined number of times while increasing or decreasing the sweep frequency in each iteration such that the sweep frequency increases or decreases from a sweep start frequency to a sweep end frequency F. Identify from the records stored in the memory the optimal frequency of the AC drive signal, which is the sweep frequency at which the maximum active power is used by the ultrasonic transducer G. Control the AC driver to output an AC drive signal to the ultrasonic transducer at the optimal frequency to drive the ultrasonic transducer to atomize the liquid.

[0014] In some examples, the driver device is releasably attached to the mist generator such that the driver device is separable from the mist generator.

[0015] According to another aspect, there is provided a mist generator incorporating: An elongate mist generator housing having an air inlet port and a mist outlet port A liquid chamber provided within the mist generator housing for containing the liquid to be atomized An ultrasonic processing chamber provided within the mist generator housing A capillary element extending between a liquid chamber and an ultrasonic treatment chamber, wherein a first portion of the capillary element is within the liquid chamber and a second portion of the capillary element is within the ultrasonic treatment chamber An ultrasonic transducer having a generally planar atomization surface provided within the ultrasonic treatment chamber, the ultrasonic transducer being mounted within the mist generator housing such that the plane of the atomization surface is substantially parallel to the longitudinal length of the mist generator housing. A part of the second portion of the capillary element overlaps a part of the atomization surface, and the ultrasonic transducer is configured to vibrate the atomization surface to atomize the liquid carried by the second portion of the capillary element to generate a mist composed of atomized liquid and air within the ultrasonic treatment chamber. The ultrasonic treatment apparatus according to claim 1 An airflow arrangement that provides an airflow path between an air inlet port, an ultrasonic treatment chamber, and an air outlet port such that a user sucking at a mist outlet port passes through the inlet port, through the ultrasonic treatment chamber, and out through the mist outlet port, and a mist inhaler in which the mist generated in the ultrasonic treatment chamber is carried out by air through the mist outlet port for inhalation by the user In some examples, the mist generating device includes: a transducer holder held within the mist generator housing, the transducer element holding the ultrasonic transducer and holding the second portion of the capillary element that overlaps a part of the atomization surface, and a partition that provides a barrier between the liquid chamber and the ultrasonic treatment chamber, the partition further including a capillary opening through which a part of the first portion of the capillary element extends

[0016] In some examples, the transducer holder is liquid silicone rubber

[0017] In some examples, the liquid silicone rubber has a Shore A 60 hardness

[0018] In some cases, the capillary opening is an elongated slot with a width of 0.2 mm to 0.4 mm.

[0019] In some examples, the capillary element is generally planar, having a first part that is generally rectangular in shape and a second part that is partially circular in shape.

[0020] In some examples, the capillary elements have a thickness of substantially 0.28 mm.

[0021] In some examples, a capillary element consists of a first part and a second part that are superimposed on each other so that the capillary element has two layers.

[0022] In some examples, the capillary elements consist of at least 75% bamboo fibers.

[0023] The capillary elements are 100% bamboo fiber.

[0024] In some examples, the airflow configuration is configured to change the direction of the airflow along the airflow channel so that the airflow is substantially perpendicular to the atomizing surface of the ultrasonic transducer as it passes through the ultrasonic processing chamber.

[0025] In some cases, the change in airflow direction is effectively 90 degrees.

[0026] In some examples, the airflow arrangement is substantially 11.5 mm 2 The present invention provides an airflow channel having an average cross-sectional area.

[0027] In some examples, the mist generator includes: at least one absorbent element located adjacent to the mist outlet port and which absorbs liquid at the mist outlet port.

[0028] In some examples, each absorbent element is bamboo fiber.

[0029] In some cases, the mist generator housing is made of heterogeneous copolymer, at least in part.

[0030] In some examples, the heterogeneous copolymer is polypropylene.

[0031] In some examples, the ultrasonic transducer is circular and has a diameter of approximately 16 mm.

[0032] In some examples, the liquid chamber contains a liquid having a kinematic viscosity between 1.05 Pa-s and 1.412 Pa-s and a liquid density between 1.1 g / ml and 1.3 g / ml.

[0033] In some examples, the liquid chamber contains a liquid containing a nicotine levulinate salt in a 1:1 molar ratio.

[0034] In some examples, the mist generator further comprises an identification arrangement provided in the mist generator housing, the identification arrangement comprising an integrated circuit having a memory for storing a unique identifier for the mist generator, and an electrical connection providing an electronic interface for communicating with the integrated circuit.

[0035] In some examples, the memory of the integrated circuit stores a record of the state of the mist generator, indicating either the historical use of the mist generator or at least one of the volume of liquid in the liquid chamber.

[0036] According to one embodiment, a driver device for a mist inhaler is provided, the device comprising: battery An AC driver that converts the voltage from the battery into an AC drive signal of a predetermined frequency to drive an ultrasonic transducer. An active power monitoring arrangement for monitoring the active power used by an ultrasonic transducer when the ultrasonic transducer is driven by an AC drive signal, the arrangement providing a monitoring signal indicating the active power used by the ultrasonic transducer. A processor for controlling AC drivers and receiving monitoring signals from active power monitoring arrangements. Memory that stores instructions that, when executed by the processor, cause the processor to do the following: A. Control the AC driver to output an AC drive signal to the ultrasonic transducer at a predetermined sweep frequency. B. Calculate the active power used by the ultrasonic transducer based on the monitoring signal. C. Control the AC driver to modulate the AC drive signal and maximize the active power used by the ultrasonic transducer. D. Record and save in memory the maximum active power used by the ultrasonic transducer and the sweep frequency of the AC drive signal. E. After a predetermined number of iterations, steps A to D are repeated a predetermined number of times, with the sweep frequency increasing or decreasing in each iteration, so that after a predetermined number of iterations, the sweep frequency increases or decreases from the sweep start frequency to the sweep end frequency. F. From the records stored in memory, identify the optimal frequency of the AC drive signal, which is the sweep frequency of the AC drive signal at which the ultrasonic transducer uses the maximum active power. G. The AC driver is controlled to output an AC drive signal to the ultrasonic transducer at the optimal frequency, driving the ultrasonic transducer to atomize the liquid.

[0037] In some examples, the active power monitoring configuration includes a current sensing configuration for sensing the drive current of the AC drive signal that drives the ultrasonic transducer, and the active power monitoring configuration provides a monitoring signal indicating the sensed drive current.

[0038] In some examples, the current sensing configuration includes an analog-to-digital converter that converts the sensed drive current into a digital signal for processing by the processor.

[0039] In some examples, memory stores instructions that, when executed by the processor, instruct the processor to repeat steps A through D, where the sweep frequency increases from a sweep start frequency of 2900 kHz to a sweep end frequency of 2960 kHz.

[0040] In some examples, memory stores instructions for the processor to repeat steps A through D, where the sweep frequency increases from a sweep start frequency of 2900 kHz to a sweep end frequency of 3100 kHz, once executed by the processor.

[0041] In some examples, memory stores an instruction that, when executed by the processor, causes the processor to control an AC driver to output an AC drive signal to an ultrasonic transducer at a frequency shifted by a predetermined amount from the optimal frequency in step G.

[0042] In some examples, the given shift amount is between 1% and 10% of the optimal frequency.

[0043] In some examples, the battery is a 3.7V DC Li-Po battery.

[0044] In some examples, the driver device further includes pressure sensors for sensing the airflow along the driver device flow path extending through the driver device.

[0045] In some examples, the driver device further comprises a wireless communication system that communicates with the processor, and the wireless communication system is configured to transmit and receive data between the driver device and the computing device.

[0046] In some examples, the driver device further comprises a driver device housing which is at least partly metal, the driver device housing accommodating a battery, processor, memory, active power monitoring arrangement and AC driver, and the driver device housing includes recesses for receiving and holding a portion of the mist generator.

[0047] In some cases, the AC driver modulates the AC drive signal by pulse width modulation to maximize the active power used by the ultrasonic transducer.

[0048] It should be noted that the term “mist” as used in the following disclosure means that the liquid is not heated as is typically done in conventional inhalers known from the prior art. In fact, conventional inhalers use a heating element to heat the liquid above its boiling point to generate vapor, which is different from mist.

[0049] In fact, when a liquid is ultrasonically treated with high intensity, the sound waves propagating through the liquid medium alternate between high-pressure (compression) and low-pressure (dilution) cycles at different speeds depending on the frequency. In the low-pressure cycle, the high-intensity ultrasound creates tiny vacuum bubbles and voids in the liquid. When these bubbles reach a volume where they can no longer absorb energy, they collapse violently in the high-pressure cycle. This phenomenon is called cavitation. At this time, extremely high pressure is generated locally. In cavitation, broken capillary waves are generated, and tiny droplets that have broken the surface tension of the liquid are rapidly released into the air as a mist.

[0050] The cavitation phenomenon will be explained in more detail below.

[0051] When a liquid is atomized by ultrasonic vibrations, tiny water bubbles are generated within the liquid.

[0052] The formation of these bubbles is a process of cavity formation caused by negative pressure resulting from strong ultrasonic waves generated by ultrasonic vibration means.

[0053] During a positive pressure cycle, the cavity size becomes relatively small and negligible, leading to rapid cavity growth due to high-intensity ultrasound.

[0054] Ultrasound, like other sound waves, consists of cycles of compression and expansion. When in contact with a liquid, the compression cycle applies positive pressure to the liquid, pushing molecules together. The expansion cycle applies negative pressure, pulling molecules apart.

[0055] Strong ultrasound creates positive and negative pressure regions. Cavities can form and grow under negative pressure. When a cavity reaches a critical size, it collapses.

[0056] The required negative pressure varies depending on the type and purity of the liquid. For highly pure liquids, the tensile strength is so high that commercially available ultrasonic generators cannot generate sufficient negative pressure to form a cavity. For example, pure water requires a negative pressure of over 1,000 atmospheres, but even the most powerful ultrasonic generators only produce about 50 atmospheres. The tensile strength of a liquid is reduced by gas trapped in the gaps between liquid particles. This effect is similar to the strength reduction caused by cracks in solid materials. When a negative pressure cycle using sound waves is applied to a gas-filled gap, the pressure drop causes the gas in the gap to expand, releasing small bubbles into the solution.

[0057] However, bubbles exposed to ultrasound continue to absorb energy by repeatedly undergoing cycles of compression and expansion caused by the sound waves. This causes the bubbles to grow and contract, maintaining a dynamic balance between the voids inside the bubbles and the surrounding liquid. Ultrasound can also change the size of the bubbles, and in some cases, it can increase the average size of the bubbles.

[0058] Cavity growth depends on sound intensity. High-intensity ultrasound can rapidly expand the cavity during negative pressure cycles, leaving no opportunity for the cavity to contract during positive pressure cycles. In this way, the cavity can grow rapidly within a single sound wave cycle.

[0059] In the case of low-intensity ultrasound, the size of the cavity vibrates in phase with the expansion and compression cycles. The surface of the cavity created by low-intensity ultrasound becomes slightly larger during the expansion cycle than during the compression cycle. Since the amount of gas entering and leaving the cavity depends on the surface area, diffusion into the cavity is slightly greater during the expansion cycle than during the compression cycle. In other words, with each sound cycle, the cavity expands slightly more than it contracts. Over many repetitions, the cavity slowly grows larger.

[0060] It is known that the grown cavity eventually reaches a critical size at which it most efficiently absorbs ultrasonic energy. This critical size depends on the ultrasonic frequency. If the cavity grows very rapidly due to high-intensity ultrasonic waves, it can no longer efficiently absorb energy from the ultrasound. Without this energy input, the cavity can no longer maintain itself. Liquid rushes in, and the cavity collapses due to a nonlinear response.

[0061] The energy released by the implosion breaks the liquid down into fine particles, which are then dispersed into the air as a mist.

[0062] The equations describing the above nonlinear response phenomena can be expressed by the Rayleigh-Presset equations. These equations can be derived from the Navier-Stokes equations used in fluid dynamics.

[0063] The inventors' approach was to rewrite the Rayleigh-Presset equation, which uses bubble volume V as a dynamic parameter and describes dissipation in the same way as the more classical form used with radius as the dynamic parameter.

[0064] This equation is derived as follows:

[0065]

number

[0066] In ultrasonic atomizing inhalers, the kinematic viscosity of the liquid is between 1.05 pascals and 1.412 pascals.

[0067] By solving the above equation with viscosity, density, and the desired target bubble volume for liquid atomization into air as appropriate parameters, it has been found that a frequency range of 2.8 MHz to 3.2 MHz produces a bubble volume of approximately 0.25 microns to 0.5 microns for liquid viscosities in the ranges of 1.05 Pascals and 1.412 Pascals.

[0068] The ultrasonic cavitation process significantly affects the nicotine concentration in the generated mist.

[0069] Because it does not use a heating element, there is no risk of the heating element burning, and the effects of secondhand smoke can be reduced.

[0070] In some examples, the liquid contains 57-70% (w / w) vegetable glycerin and 30-43% (w / w) propylene glycol, wherein the propylene glycol contains nicotine and optionally a flavoring.

[0071] In an ultrasonic mist inhaler, the capillary element may extend between the ultrasonic treatment chamber and the liquid chamber.

[0072] In an ultrasonic mist inhaler, the capillary elements are made of a material that is at least partially bamboo fiber.

[0073] The capillary element enables not only high absorption capacity and high absorption rate, but also high liquid retention.

[0074] The unique properties of the proposed materials used in the capillaries were found to have a significant impact on the efficient function of the ultrasonic mist inhaler.

[0075] Furthermore, a unique property of this material is that it maintains good moisture permeability while also possessing good hygroscopic properties. This allows the aspirated liquid to efficiently penetrate the capillaries, and its high water absorption capacity enables it to hold a large amount of liquid, allowing the ultrasonic mist inhaler to be used for a longer period compared to other commercially available products.

[0076] Another major advantage of using bamboo fiber is that it has antibacterial, antifungal, and deodorizing properties due to "kun," a naturally occurring antimicrobial biological agent found within the bamboo fiber, making it suitable for medical applications.

[0077] These unique properties of bamboo fiber have been verified through numerical analysis regarding the advantages of bamboo fiber in ultrasonic treatment.

[0078] The following formula has been tested with bamboo fiber material and other materials such as cotton, paper, or other fiber strands for use as capillary elements, demonstrating that bamboo fiber has far superior properties for use in ultrasonic processing:

[0079]

number

[0080] In an ultrasonic mist inhaler, the capillary elements can be made of a material in which at least a portion is bamboo fiber.

[0081] Furthermore, in an ultrasonic mist inhaler, the material for the capillary element can be 100% bamboo fiber.

[0082] Extensive testing has concluded that 100% pure bamboo fiber is the most optimal choice for ultrasonic treatment.

[0083] In ultrasonic mist inhalers, the material of the capillary elements may be at least 75% bamboo fiber, with an optional 25% cotton.

[0084] Capillary elements made from 100% pure bamboo fiber or a high proportion of bamboo fiber not only exhibit high absorption capacity but also possess improved fluid permeability, making them an optimal choice for ultrasonic mist inhaler applications.

[0085] In an ultrasonic mist inhaler, the capillary element may have a flat shape.

[0086] In an ultrasonic mist inhaler, the capillary element may consist of a central portion and a peripheral portion.

[0087] In an ultrasonic mist inhaler, the peripheral portion may have an L-shaped cross-section extending toward the liquid chamber.

[0088] In an ultrasonic mist inhaler, the central portion may have a U-shaped cross-section that extends to the ultrasonic processing chamber.

[0089] An ultrasonic mist inhaler according to one example, characterized in that the liquid received in the liquid chamber contains 57-70% (w / w) vegetable glycerin and 30-43% (w / w) propylene glycol, and the propylene glycol contains nicotine and a fragrance.

[0090] An ultrasonic mist inhaler or personal ultrasonic atomizer includes: A liquid reservoir structure including a liquid chamber or cartridge adapted to receive the liquid to be atomized. Ultrasonic processing chamber that is in fluid communication with the liquid chamber or the cartridge. The liquid received in the liquid chamber contains 57-70% (w / w) vegetable glycerin and 30-43% (w / w) propylene glycol, the propylene glycol containing nicotine and fragrance. [Brief explanation of the drawing]

[0091] To make the present invention easier to understand, embodiments of the present invention will now be described by example with reference to the accompanying drawings: [Figure 1] Figure 1 is an exploded perspective view of the components of an ultrasonic mist inhaler. [Figure 2] Figure 2 is an exploded perspective view of the components of the inhaler liquid reservoir structure. [Figure 3] Figure 3 is a cross-sectional view of the components of the inhaler liquid reservoir structure. [Figure 4A] Figure 4A is an isometric view of the airflow member of the inhaler liquid reservoir structure shown in Figures 2 and 3. [Figure 4B] Figure 4B is a cross-sectional view of the air blower shown in Figure 4A. [Figure 5] Figure 5 is a schematic diagram showing a piezoelectric transducer modeled as an RLC circuit. [Figure 6] Figure 6 is a graph of frequency versus logarithmic impedance for an RLC circuit. [Figure 7] Figure 7 is a graph of frequency versus logarithmic impedance showing the inductive and capacitive operating regions of a piezoelectric transducer. [Figure 8] Figure 8 is a flowchart illustrating the operation of the frequency controller. [Figure 9] Figure 9 is a schematic perspective view of the mist inhaler of the present disclosure. [Figure 10] Figure 10 is a schematic perspective view of the mist inhaler of the present disclosure. [Figure 11] Figure 11 is a perspective view of the mist generating apparatus of the present disclosure. [Figure 12] Figure 12 is a perspective view of the mist generating apparatus of the present disclosure. [Figure 13] Figure 13 is an exploded perspective view illustrating the mist generator of the present disclosure. [Figure 14] Figure 14 is a perspective view of the transducer holder of this disclosure. [Figure 15] Figure 15 is a perspective view of the transducer holder of this disclosure. [Figure 16] Figure 16 is a perspective view of the capillary element of this disclosure. [Figure 17]Figure 17 is a perspective view of the capillary element of the present disclosure. [Figure 18] Figure 18 is a perspective view of the transducer holder of this disclosure. [Figure 19] Figure 19 is a perspective view of the transducer holder of this disclosure. [Figure 20] Figure 20 is an illustrative perspective view of a portion of the housing of this disclosure. [Figure 21] Figure 21 is a perspective view of the absorbent element of this disclosure. [Figure 22] Figure 22 is an illustrative perspective view of a portion of the housing of this disclosure. [Figure 23] Figure 23 is an illustrative perspective view of a portion of the housing of this disclosure. [Figure 24] Figure 24 is a perspective view of the absorbent element of this disclosure. [Figure 25] Figure 25 is an illustrative perspective view of a portion of the housing of this disclosure. [Figure 26] Figure 26 is an illustrative perspective view of a portion of the housing of this disclosure. [Figure 27] Figure 27 is an illustrative perspective view of a portion of the housing of this disclosure. [Figure 28] Figure 28 is an illustrative perspective view of the circuit board of this disclosure. [Figure 29] Figure 29 is an illustrative perspective view of the circuit board of this disclosure. [Figure 30] Figure 30 is an exploded perspective view illustrating the mist generator of the present disclosure. [Figure 31] Figure 31 is an exploded perspective view illustrating the mist generator of the present disclosure. [Figure 32] Figure 32 is a cross-sectional view showing the mist generating apparatus of this disclosure. [Figure 33] Figure 33 is a cross-sectional view showing the mist generating apparatus of this disclosure. [Figure 34] Figure 34 is a cross-sectional view showing the mist generating apparatus of this disclosure. [Figure 35] Figure 35 is an exploded perspective view of the driver device of the present disclosure. [Figure 36] Figure 36 is a perspective view showing a part of the driver device of this disclosure. [Figure 37] Figure 37 is a perspective view showing a part of the driver device of this disclosure. [Figure 38] Figure 38 is a perspective view showing a part of the driver device of this disclosure. [Figure 39] Figure 39 is a perspective view showing a part of the driver device of this disclosure. [Figure 40] Figure 40 is a perspective view showing a part of the driver device of this disclosure. [Figure 41] Figure 41 is a perspective view showing a part of the driver device of this disclosure. [Figure 42] Figure 42 is a perspective view showing a part of the driver device of this disclosure. [Figure 43] Figure 43 is a schematic diagram of the integrated circuit layout of the present disclosure. [Figure 44] Figure 44 is a schematic diagram of the integrated circuit of this disclosure. [Figure 45] Figure 45 is a schematic diagram of the pulse width modulation generator of this disclosure. [Figure 46] Figure 46 is a timing diagram of an example of this disclosure. [Figure 47] Figure 47 is a timing diagram of an example of this disclosure. [Figure 48] Figure 48 is a table showing an example of port functionality in this disclosure. [Figure 49] Figure 49 is a schematic diagram of the integrated circuit of this disclosure. [Figure 50] Figure 50 is a circuit diagram of an example of an H-bridge in this disclosure. [Figure 51] Figure 51 is a circuit diagram of an example of a current sensing arrangement in this disclosure. [Figure 52] Figure 52 is a circuit diagram of an example of an H-bridge in this disclosure. [Figure 53] Figure 53 is a graph showing the voltages between phases during the operation of the H-bridge in Figure 50. [Figure 54] Figure 54 is a graph showing the voltages between phases during the operation of the H-bridge in Figure 50. [Figure 55] Figure 55 is a graph showing the voltage and current at the terminals of the ultrasonic transducer while the ultrasonic transducer is driven by the H-bridge in Figure 50. [Figure 56] Figure 56 is a schematic diagram showing the connections between the integrated circuits of this disclosure. [Figure 57] Figure 57 is a schematic diagram of the integrated circuit of this disclosure. [Figure 58] Figure 58 is a diagram illustrating the steps of an example authentication method of this disclosure. [Figure 59] Figure 59 is a perspective view of the end cap of the driver device of this disclosure. [Figure 60] Figure 60 is a perspective view of the housing of the driver device of this disclosure. [Figure 61] Figure 61 is a graph showing the results of EMC tests for the mist inhaler of this disclosure. [Modes for carrying out the invention]

[0092] Detailed explanation The aspects of this disclosure will be best understood from the following detailed description when read in conjunction with the attached figures. Note that, in accordance with standard practice in this industry, various features are not depicted to scale. In fact, the dimensions of various features may be increased or decreased as appropriate for the sake of clarity in the discussion.

[0093] The following disclosure provides many different embodiments, or examples, for carrying out different features of the subject matter provided. Specific examples of components, concentrations, uses, and arrangements are described below for the sake of brevity of this disclosure. Of course, these are merely examples and are not intended to limit the scope. For example, the mounting of the first and second features in the following description may include embodiments in which the first and second features are mounted in direct contact, or it may include embodiments in which an additional feature may be positioned between the first and second features so that the first and second features are not in direct contact. In addition, this disclosure may repeat reference numerals and / or letters in various examples. This repetition is for simplification and clarity and does not in itself indicate relationships between the various embodiments and / or configurations discussed.

[0094] The following disclosures describe representative examples. Each example may be considered an embodiment, and in this disclosure, the reference to “example” may be replaced with “embodiment.”

[0095] Some parts of this disclosure are directed toward electronic vapor inhalers. The specific examples described below include nicotine. However, other examples are also envisioned, such as inhalers for therapeutic drugs, medicines, and herbal supplements. Furthermore, the device can be packaged to resemble a medical device that does not resemble a cigarette.

[0096] Ultrasonic mist inhalers are either disposable or reusable. As used in this document, the term “reusable” means that the energy storage device is rechargeable or replaceable, or that the liquid can be replenished by either refilling or replacing the liquid reservoir structure. Alternatively, in some examples, a reusable electronic device is both rechargeable and can have its liquid replenished.

[0097] Conventional electronic vaporizers tend to rely on inducing high temperatures in metal components configured to heat the liquid inside the inhaler, thereby vaporizing the inhalable liquid. The liquid typically contains nicotine and flavorings blended in a solution of propylene glycol (PG) and vegetable glycerin (VG), which are vaporized via the heating component at high temperatures. Problems with conventional inhalers include the possibility of the metal catching fire, and subsequently inhaling the metal along with the burnt liquid. Also, some people dislike the burnt smell and taste from the heated liquid.

[0098] Figures 1 to 4 show an example of an ultrasonic inhaler that constitutes an ultrasonic treatment chamber.

[0099] Figure 1 illustrates a disposable ultrasonic mist inhaler 100. As can be seen from Figure 1, the ultrasonic mist inhaler 100 has a cylindrical body that is relatively long relative to its diameter. In the disposable example, the first and second parts are areas of a single, but separable, device. The designations first part 101 and second part 102 are used for convenience to distinguish the components mainly contained in each part.

[0100] As can be seen from Figure 1, the ultrasonic mist inhaler consists of a mouthpiece 1, a reservoir structure 2, and a casing 3. The first part 101 constitutes the casing 3, and the second part 102 constitutes the mouthpiece 1 and the reservoir structure 2.

[0101] The first part 101 contains power energy.

[0102] The power storage device 30 supplies power to the ultrasonic mist inhaler 100. The power storage device 30 may be, but is not limited to, a battery such as a lithium-ion battery, alkaline battery, zinc-carbon battery, nickel-metal hydride battery, nickel-cadmium battery, supercapacitor, or a combination thereof. In a disposable example, the power storage device 30 is not rechargeable, but in a reusable example, the power storage device 30 would be selected to be rechargeable. In a disposable example, the power storage device 30 is mainly selected to supply a constant voltage over the lifespan of the inhaler 100. Otherwise, the performance of the inhaler will degrade over time. Preferred power storage devices that can provide a constant voltage output over the lifespan of the device include lithium-ion batteries and lithium polymer batteries.

[0103] The electrical storage device 30 has a first end 30a that generally corresponds to a positive terminal and a second end 30b that generally corresponds to a negative terminal. The negative terminal extends to the first end 30a.

[0104] Since the energy storage device 30 is located in the first part 101 and the liquid reservoir structure 2 is located in the second part 102, the joint needs to provide electrical communication between these components. In this invention, electrical communication is established using at least electrodes or probes that are compressed together when the first part 101 is fastened to the second part 102.

[0105] In this example, the energy storage device 30 is rechargeable for reuse. The casing 3 is provided with a charging port 32.

[0106] The integrated circuit 4 has a proximal end 4a and a distal end 4b. The positive terminal of the first end 30a of the electrical storage device 30 is in electrical communication with the positive lead of the flexible integrated circuit 4. The negative terminal of the second end 30b of the electrical storage device 30 is in electrical communication with the negative lead of the integrated circuit 4. The distal end 4b of the integrated circuit 4 comprises a microprocessor. The microprocessor is configured to process data from the sensor, control the light, instruct the ultrasonic vibration 5 in the second part 102 to flow current, and terminate the current flow after a pre-programmed time.

[0107] The sensor detects when the ultrasonic mist inhaler 100 is in use (when the user inhales from the inhaler) and activates the microprocessor. The sensor can be selected to detect changes in pressure, airflow, or vibration. In one example, the sensor is a pressure sensor. In digital devices, the sensor performs continuous readings, and as a result, the digital sensor needs to continuously draw current, but the amount is small and will have a negligible impact on the overall battery life.

[0108] In some examples, the integrated circuit 4 constitutes an H-bridge, which may be formed by four MOSFETs to convert DC to AC at high frequencies.

[0109] Referring to Figures 2 and 3, an illustration of an example of a liquid reservoir structure 2 is shown. The liquid reservoir structure 2 consists of a liquid chamber 21 adapted to receive the liquid to be atomized, and an ultrasonic treatment chamber 22 that is in fluid communication with the liquid chamber 21.

[0110] In the example shown, the liquid reservoir structure 2 includes an intake channel 20 that provides an air passage from the ultrasonic processing chamber 22 to the surroundings.

[0111] As an example of a sensor location, the sensor may be placed in the ultrasonic processing chamber 22.

[0112] The inhalation channel 20 has a conical portion 20a and an internal container 20b.

[0113] As shown in Figures 4A and 4B, the intake channel 20 further includes an airflow member 27 for supplying airflow from the surroundings to the ultrasonic processing chamber 22.

[0114] The airflow member 27 has an integrally formed airflow bridge 27a and an airflow duct 27b, the airflow bridge 27a having two airway openings 27a' that form part of the intake channel 20, and the airflow duct 27b extending from the airflow bridge 27a into the ultrasonic treatment chamber 22 to provide airflow from the surroundings into the ultrasonic treatment chamber.

[0115] The airflow bridge 27a cooperates with the conical element 20a at the second diameter 20a2.

[0116] The airflow bridge 27a has two opposing peripheral openings 27a'' that supply airflow to the airflow duct 27b.

[0117] The cooperation between the airflow bridge 27a and the frustration conical element 20a is arranged such that two opposing peripheral openings 27a'' cooperate with the complementary opening 20a'' of the frustration conical element 20a.

[0118] The nozzle 1 and the conical section 20a are spaced apart radially, with the airflow chamber 28 positioned between them.

[0119] As shown in Figures 1 and 2, the mouthpiece 1 has two opposing peripheral openings 1''.

[0120] The peripheral openings 27a'', 20a'', 1'', of the airflow bridge 27a, the frustrated conical element 20a, and the mouthpiece 1 directly supply the maximum airflow to the ultrasonic treatment chamber 22.

[0121] The conical element 20a includes an internal passage aligned in the same direction as the intake channel 20, and has an internal passage such that the first diameter 20a1 is smaller than that of the second diameter 20a2, and the internal passage decreases in diameter over the conical element 20a.

[0122] The conical element 20a is positioned in alignment with the ultrasonic vibration means 5 and the capillary element 7, with a first diameter 20a1 communicating with the internal duct 11 of the mouthpiece 1 and a second diameter 20a2 communicating with the internal container 20b.

[0123] The inner container 20b has an inner wall that separates the ultrasonic processing chamber 22 and the liquid chamber 21.

[0124] The liquid reservoir structure 2 has an outer container 20c that partitions the outer wall of the liquid chamber 21.

[0125] The inner container 20b and the outer container 20c are the inner and outer walls of the liquid chamber 21, respectively.

[0126] The liquid reservoir structure 2 is positioned between the nozzle 1 and the casing 3 and is detachable from the nozzle 1 and the casing 3.

[0127] The liquid reservoir structure 2 and the mouthpiece 1 or casing 3 may include complementary arrangements for engaging with each other; further, such complementary arrangements may include bayonet-type arrangements; screw-engagement-type arrangements; magnetic arrangements; or friction-fit arrangements, where the liquid reservoir structure 2 includes a portion of the arrangement and the mouthpiece 1 or casing 3 includes a complementary portion of the arrangement.

[0128] In the reusable example, the components are substantially the same. The difference between the reusable example and the disposable example lies in the housing used to replace the liquid reservoir structure 2.

[0129] As shown in Figure 3, the liquid chamber 21 has an upper wall 23 and a bottom wall 25 that close the inner container 20b and the outer container 20c of the liquid chamber 21.

[0130] The capillary element 7 is positioned between the first part 20b1 and the second part 20b2 of the inner container 20b.

[0131] The capillary element 7 has a flat shape that extends from the ultrasonic treatment chamber to the liquid chamber.

[0132] As shown in Figure 2 or Figure 3, the capillary element 7 is composed of a U-shaped central part 7a and an L-shaped peripheral part 7b.

[0133] The L-shaped portion 7b extends along the bottom wall 25 into the liquid chamber 21 on the inner container 20b.

[0134] The U-shaped portion 7a is housed within the ultrasonic processing chamber 21. The U-shaped portion 7a is positioned on the inner container 20b so as to follow the bottom wall 25.

[0135] In the ultrasonic atomizing inhaler, the U-shaped portion 7a has an inner portion 7a1 and an outer portion 7a2. The inner portion 7a1 is in surface contact with the atomizing surface 50 of the ultrasonic vibration means 5, while the outer portion 7a2 is not in surface contact with the ultrasonic vibration means 5.

[0136] The bottom wall 25 of the liquid chamber 21 is a bottom plate 25 that seals the liquid chamber 21 and the ultrasonic treatment chamber 22. Since the bottom plate 25 is sealed, leakage of liquid from the ultrasonic treatment chamber 22 to the casing 3 is prevented.

[0137] The base plate 25 has an upper surface 25a with a recess 25b into which the elastic member 8 is inserted. The ultrasonic vibration means 5 is supported by the elastic member 8. The elastic member 8 is formed from an annular plate-shaped rubber having an inner hole 8' designed with a groove for holding the ultrasonic vibration means 5.

[0138] The upper wall 23 of the liquid chamber 21 is a cap 23 that closes the liquid chamber 23.

[0139] The top wall 23 has an upper surface 23 that represents the maximum level of liquid that the liquid chamber 21 can accommodate, and a lower surface 25 that represents the minimum level of liquid in the liquid chamber 21.

[0140] Since the top wall 23 is sealed, leakage of liquid from the liquid chamber 21 to the nozzle 1 is prevented.

[0141] The top wall 23 and the bottom wall 25 are fixed to the liquid reservoir structure 2 by fastening means such as screws, adhesives, or friction.

[0142] As shown in Figure 3, the elastic member is in line contact with the ultrasonic vibration means 5, and by preventing contact between the ultrasonic vibration means 5 and the wall of the inhaler, vibration of the liquid reservoir structure is more effectively suppressed. Therefore, the fine particles of liquid atomized by the atomizing member can be sprayed over a greater distance.

[0143] As shown in Figure 3, the inner container 20b has an opening 20b' between the first part 20b1 and the second part 20b2, through which a capillary element 7 extends from the ultrasonic treatment chamber 21. The capillary element 7 absorbs liquid from the liquid chamber 21 through the opening 20b'. The capillary element 7 is a wick. The capillary element 7 transports the liquid to the ultrasonic treatment chamber 22 by capillary action. In some examples, the capillary element 7 is made of bamboo fiber. In some examples, the capillary element 7 has a thickness between 0.27 mm and 0.32 mm and a weight of 38 g / m². 2 From 48g / m 2 It may have a density between [the specified values].

[0144] As can be seen from Figure 3, the ultrasonic vibration means 5 is positioned directly below the capillary element 7.

[0145] The ultrasonic vibration means 5 may be a transducer. For example, the ultrasonic vibration means 5 may be a piezoelectric transducer and may be designed in the shape of a circular plate. The material of the piezoelectric transducer may be ceramic.

[0146] Furthermore, various transducer materials can be used for the ultrasonic vibration means 5.

[0147] The end of the air duct 27b1 faces the ultrasonic vibration means 5. The ultrasonic vibration means 5 is in electrical contact with the electrical contactors 101a and 101b. Notably, the distal end 4b of the integrated circuit 4 has an inner electrode and an outer electrode. The inner electrode contacts the first electrical contact 101a, which is a spring contact probe, and the outer electrode contacts the second electrical contact 101b, which is a side pin. Through the integrated circuit 4, the first electrical contact 101a communicates electrically with the positive terminal of the energy storage device 30 via a microprocessor, and the second electrical contact 101b communicates electrically with the negative terminal of the energy storage device 30.

[0148] Electrical contacts 101a and 101b traverse the bottom plate 25. The bottom plate 25 is positioned to be received inside the peripheral wall 26 of the liquid reservoir structure 2. The bottom plate 25 rests on complementary protrusions, thereby forming the liquid chamber 21 and the ultrasonic processing chamber 22.

[0149] The inner container 20b consists of a circular inner slot 20d to which a mechanical spring is applied.

[0150] By pressing the central portion 7a1 against the ultrasonic vibration means 5, the mechanical spring 9 ensures a contact surface between them.

[0151] The liquid reservoir structure 2 and the bottom plate 25 can be made using various thermoplastic materials.

[0152] When a user inhales into the ultrasonic mist inhaler 100, airflow is drawn in through the peripheral opening 1'', passes through the airflow chamber 28, through the peripheral opening 27a'' of the airflow bridge 27a and the frustconical element 20a, flows down through the airflow duct 27b into the ultrasonic processing chamber 22, and directly comes into contact with the capillary element 7. Simultaneously, liquid is drawn into the capillary element 7 from the reservoir chamber 21 through multiple openings 20b' by capillary action. The capillary element 7 brings the liquid into contact with the ultrasonic vibration means 5 of the inhaler 100. In addition, the user's inhalation activates the integrated circuit 4, which in turn conducts an electric current to the ultrasonic vibration means 5. Thus, when a user inhales into the mouthpiece 1 of the inhaler 100, two actions occur simultaneously. First, the sensor activates the integrated circuit 4, which triggers the ultrasonic vibration means 5 to start vibrating. Secondly, the suction reduces the pressure outside the reservoir chamber 21 so that liquid flow begins through the opening 20b', saturating the capillary element 7. The capillary element 7 transports the liquid to the ultrasonic vibration means 5, which causes bubbles to form in the capillary passage and atomize the liquid. The user then sucks up the atomized liquid.

[0153] In some examples, the integrated circuit 4 includes a frequency controller configured to control the frequency on which the ultrasonic vibration means 5 operates. The frequency controller comprises a processor and memory, the memory storing executable instructions that, when executed by the processor, cause the processor to perform at least one function of the frequency controller.

[0154] As described above, in some examples, the ultrasonic mist inhaler 100 drives the ultrasonic vibrating means 5 with a signal having a frequency of 2.8 MHz to 3.2 MHz to vaporize a liquid having a viscosity of 1.05 Pa·s to 1.412 Pa·s in order to produce a bubble volume of approximately 0.25 to 0.5 microns. However, for liquids with different viscosities or for other applications, it may be possible to drive the ultrasonic vibrating means 5 with different frequencies.

[0155] For each different application of the mist generator, there is an optimal frequency or frequency range for driving the ultrasonic vibration means 5 to optimize mist generation. In the example where the ultrasonic vibration means 5 is a piezoelectric transducer, the optimal frequency or frequency range will depend on at least the following four parameters.

[0156] 1. Transducer manufacturing process In some examples, the ultrasonic vibration means 5 is made of piezoelectric ceramic. Piezoelectric ceramics are manufactured by mixing compounds to create a ceramic base, but this mixing process may not be consistent throughout the manufacturing process. This non-uniformity can result in variations in the resonant frequency of the cured piezoelectric ceramic.

[0157] If the resonant frequency of the piezoelectric ceramic does not correspond to the required operating frequency of the device, mist will not be generated during operation. In the case of therapeutic mist inhalers, even a slight deviation in the resonant frequency of the piezoelectric ceramic can affect mist generation, meaning that the device may not be able to provide the user with an appropriate level of treatment.

[0158] 2. Load on the transducer During operation, when the load on the piezoelectric transducer changes, the overall vibration displacement of the piezoelectric transducer is suppressed. To optimally displace the vibration of the piezoelectric transducer, the drive frequency needs to be adjusted so that the circuit can supply sufficient power for the maximum displacement.

[0159] Types of loads that affect oscillator efficiency include the amount of liquid on the transducer (humidity of the wicking material) and the spring force applied to the wicking material to maintain permanent contact with the transducer. Electrical connection methods may also be included.

[0160] 3.Temperature The ultrasonic vibrations of a piezoelectric transducer are partially attenuated by incorporating them into the device. This can be done by placing the transducer in a silicone / rubber ring and applying pressure to the wicking material above the transducer with a spring. This vibration attenuation causes a localized increase in temperature on and around the transducer.

[0161] Rising temperature affects the oscillator's oscillations due to changes in the transducer's molecular behavior. Increased temperature imparts more energy to the ceramic molecules, temporarily affecting their crystal structure. This effect reverses as the temperature decreases, but modulation of the supplied frequency is necessary to maintain optimal oscillation. This frequency modulation was not possible with conventional fixed-frequency devices.

[0162] Furthermore, as the temperature rises, the viscosity of the vaporized solution (e-liquid) decreases, which may necessitate changing the drive frequency to induce cavitation and maintain continuous mist generation. In the case of conventional fixed-frequency devices, lowering the viscosity of the liquid without changing the drive frequency will reduce or completely stop mist generation, rendering the device inoperable.

[0163] 4. Distance to the power source The oscillation frequency of an electronic circuit can vary depending on the length of the wiring between the transducer and the oscillator-driver. The frequency of an electronic circuit is inversely proportional to the distance between the transducer and the rest of the circuit.

[0164] While distance parameters are primarily fixed to the device, they can change during the manufacturing process, potentially reducing the overall efficiency of the device. Therefore, it is desirable to adjust the device's driving frequency to compensate for these fluctuations and optimize the device's efficiency.

[0165] A piezoelectric transducer can be modeled as an RLC circuit in an electronic circuit, as shown in Figure 5. The four parameters mentioned above can be modeled as changes in the inductance, capacitance, and resistance of the entire RLC circuit, which can change the resonant frequency range supplied to the transducer. As the circuit frequency rises to near the transducer's resonance point, the logarithmic impedance of the entire circuit drops to a minimum, then rises to a maximum, and then settles in the middle range.

[0166] Figure 6 is a general graph illustrating the change in overall impedance with increasing frequency in an RLC circuit. Figure 7 shows a piezoelectric transducer at a first predetermined frequency f s At the following frequencies, in the first capacitive region, the second predetermined frequency f p This figure shows how it acts as a capacitor in the second capacitive region at the above frequencies. The piezoelectric transducer operates at the first and second predetermined frequencies f s ,f p Between these frequencies, it acts as an inductor in the inductive region. To maintain optimal oscillation of the transducer and thus obtain maximum efficiency, the current flowing through the transducer must be kept at frequencies within the inductive region.

[0167] In some examples, the frequency controller of the device is configured to maintain the oscillation frequency of the piezoelectric transducer (ultrasonic vibration means 5) within the induction range in order to maximize the efficiency of the device.

[0168] The frequency controller is configured to perform a sweep operation, driving the transducer at a frequency that is progressively tracked over a predetermined sweep frequency range. While the frequency controller performs the sweep, it monitors the analog-to-digital converter (ADC) value of the analog-to-digital converter coupled to the transducer. In some examples, the ADC value is an ADC parameter proportional to the voltage across the transducer. In other examples, the ADC value is an ADC parameter proportional to the current flowing through the transducer.

[0169] As will be described in more detail below, some example frequency controllers determine the effective power being used by an ultrasonic transducer by monitoring the current flowing through the transducer.

[0170] During a sweep operation, the frequency controller searches for an induction region of frequencies for the transducer. When the frequency controller identifies the induction region, the frequency controller records the ADC value and sets the drive frequency of the transducer to a frequency within the induction region (i.e., between the first and second predetermined frequencies f s , f p ) to lock in order to optimize ultrasonic cavitation by the transducer. When the drive frequency is locked within the induction region, the electromechanical coupling coefficient of the transducer is maximized, thereby maximizing the efficiency of the device.

[0171] In some examples, the frequency controller is configured to perform a sweep operation to identify the location of the induction region each time oscillation is started or restarted. In an example, the frequency controller is configured to lock the drive frequency at a new frequency within the induction region each time oscillation is started, thereby compensating for changes in parameters that affect the operating efficiency of the device.

[0172] In some examples, the frequency controller ensures optimal mist generation and maximizes the efficiency of drug delivery to the user. In some examples, the frequency controller optimizes the device, improves efficiency, and maximizes therapeutic delivery to the user.

[0173] In other examples, frequency controllers optimize devices and improve the efficiency of any other devices that use ultrasound. In some cases, frequency controllers are configured for use with ultrasound technology in therapeutic applications to extend the enhancement of drug release from ultrasound-responsive drug delivery systems. Having a precise and optimal frequency during operation ensures that microbubbles, nanobubbles, nanodroplets, liposomes, emulsions, micelles, or any other delivery system are highly effective.

[0174] In some cases, the frequency controller is configured to operate in recursive mode to ensure optimal mist generation and optimal compound delivery as described above. When the frequency controller operates in recursive mode, it periodically sweeps the frequency during device operation and monitors the ADC value to determine whether the ADC value is above a predetermined threshold indicating optimal oscillation of the transducer.

[0175] In some examples, the frequency controller performs a sweeping motion while the device is in the process of aerosolizing the liquid, in case the frequency controller can identify a possible better frequency for the transducer. If the frequency controller identifies a better frequency, it locks the drive frequency to the newly identified better frequency to maintain optimal operation of the device.

[0176] In some examples, the frequency controller periodically performs a frequency sweep for a predetermined duration during the device's operation. In the example devices described above, the predetermined duration of the sweep and the time intervals between sweeps are selected to optimize the device's function. When implemented in an ultrasonic mist inhaler, this ensures optimal delivery to the user throughout the user's inhalation.

[0177] Figure 8 is a flowchart illustrating the operation of several example frequency controllers.

[0178] The following disclosures further examples of mist inhalers comprising many of the same elements as those in the examples described above. The elements of the examples described above can be substituted with any of the elements of the examples described in the remainder of this disclosure.

[0179] To ensure sufficient aerosol generation, in this example, the mist inhaler consists of an ultrasonic / piezoelectric transducer with a diameter of exactly or substantially 16 mm. This transducer is manufactured to specific capacitance and impedance values ​​to control the frequency and power required for generating the desired amount of aerosol.

[0180] Placing a 16mm diameter disc-shaped ultrasonic transducer horizontally would result in a large device that could be ergonomically unsuitable for handheld use. To mitigate this concern, the ultrasonic transducer in this example is held vertically within the ultrasonic processing chamber (the plane of the ultrasonic transducer is roughly parallel to the flow of aerosol mist to the mouthpiece and / or roughly parallel to the longitudinal length of the mist inhaler). In other words, the ultrasonic transducer is generally perpendicular to the base of the mist inhaler.

[0181] Referring here to Figures 9 and 10 of the attached drawings, some examples of the mist inhaler 200 consist of a mist generator 201 and a driver device 202. In this example, the driver device 202 has a recess 203 that receives and holds a portion of the mist generator 201. Thus, the mist generator 201 can be combined with the driver device 202, as shown in Figure 9, to form a compact and portable mist inhaler 200.

[0182] Referring here to Figures 11 to 13 of the attached drawings, the mist generator 201 consists of a mist generator housing 204 formed from two elongated housing sections 205 and 206 that can be optionally attached to each other. The mist generator housing 204 consists of an air inlet port 207 and a mist outlet port 208.

[0183] In this example, the mist generator housing 204 is made of injection-molded plastic, specifically polypropylene, which is typically used in medical applications. In this example, the mist generator housing 204 is a heterogeneous copolymer. More specifically, it is a BF970MO heterogeneous copolymer, which has an optimal combination of very high rigidity and high impact strength. Mist generator housing components molded from this material exhibit good antistatic performance.

[0184] Heterophase copolymers such as polypropylene are particularly suitable for the mist generator housing 204 because they do not cause aerosol condensation as the material flows from the ultrasonic treatment chamber 219 through the mouthpiece to the user. This plastic material can also be easily recycled directly using industrial crushing and washing processes.

[0185] In Figures 9, 10, and 12, the mist outlet port 208 is closed by a closure element 209. However, it will be understood that when using the mist inhaler 200, the closure element 209 is removed from the mist outlet port 208, as shown in Figure 11.

[0186] Referring now to Figures 14 and 15, the mist generator 200 includes a transducer holder 210 held within the mist generator housing 204. In this example, the transducer holder 210 consists of a cylindrical or generally cylindrical body 211 and circular upper and lower openings 212, 213. The transducer holder 210 is provided with an internal channel 214 for receiving the end of an ultrasonic transducer 215, as shown in Figure 15.

[0187] The transducer holder 210 incorporates a cutout 216 through which the electrode 217 extends from the ultrasonic transducer 215, so that the electrode 217 can be electrically connected to the AC driver of the driver device, and the electrode 217 extends from the ultrasonic transducer 215, as will be described in more detail below.

[0188] Referring again to Figure 13, the mist generator 201 includes a liquid chamber 218 located within the mist generator housing 204. The liquid chamber 218 is for containing a liquid, such as a therapeutic fluid, to be atomized. In some examples, the liquid is contained within the liquid chamber 218. In other examples, the liquid chamber 218 is initially empty and then filled with liquid.

[0189] Preferably, the liquid contains at least one therapeutic agent suitable for aerosol delivery to the lungs by inhalation by the patient in order to provide the patient with the desired treatment. Some examples of therapeutic agents include, but are not limited to, aerosol delivery of pharmaceutical agents to the lungs to promote systemic or direct clinical effects while causing minimal side effects. The therapeutic agent may also include, but is not limited to, natural drugs, cannabinoid derivatives such as CBD for pain relief and other treatments, herbal medicines, opioids, RNA, DNA, chemotherapy, intracellular components including ribosomes, endoplasmic reticulum, cytoskeleton and mitochondria, supplements for performance enhancement (such as drugs like albuterol / salbutamol, β-lactam, polymyxin, aminoglycoside antibacterial antibiotics for asthma patients, amphotericin B, morphine, fentanyl, prostacyclin, amiloride, interferon G, cyclosporine for the treatment of rescue therapy rejection and asthma in lung transplant patients).

[0190] The following description refers to nicotine, but in other examples of this disclosure, nicotine may be replaced by one or more of the therapeutic agents described herein, but not limited to such therapeutic agents.

[0191] A liquid (also referred to here as e-liquid) composition comprising a nicotine salt consisting of nicotine levulinate, suitable for use in an ultrasonic device driven at a frequency of 3.0 MHz (±0.2 MHz) by a 3.7 V lithium polymer (LiPo) battery, wherein the composition is as follows: The relative amount of vegetable glycerin in the composition is: 55 to 80% (w / w), or 60 to 80% (w / w), or 65 to 75% (w / w), or 70% (w / w), and / or The relative amount of propylene glycol in the composition is: 5-30% (w / w), or 10-30% (w / w), or 15-25% (w / w), or 20% (w / w), and / or The relative amount of water in the composition is: 5 to 15% (w / w), or 7 to 12% (w / w), or 10% (w / w), and / or The amount of nicotine and / or nicotine salt in the composition is: 0.1 to 80 mg / ml, or 0.1 to 50 mg / ml, or 1 to 25 mg / ml, or 10 to 20 mg / ml, or 17 mg / ml.

[0192] In some examples, the mist generator 201 contains an electron liquid having a kinematic viscosity between 1.05 Pascals per second and 1.412 Pascals per second.

[0193] In some examples, the liquid chamber 218 contains a liquid containing nicotine levulinate salt in a 1:1 molar ratio.

[0194] In some examples, the liquid chamber 218 contains a liquid having a kinematic viscosity between 1.05 Pascal seconds and 1.412 Pascal seconds and a liquid density between 1.1 g / ml and 1.3 g / ml.

[0195] By using an electronic liquid with the correct viscosity and density parameters, and achieving the desired target bubble volume of liquid spray into air, it has been found that a liquid viscosity range of 1.05 Pascals per second to 1.412 Pascals per second and a density of approximately 1.1 to 1.3 g / mL (density range obtained from Hertz) with a frequency of 2.8 MHz to 3.2 MHz produces droplet volumes of 90% less than 1 micron and 50% less than 0.5 microns.

[0196] The mist generator 201 comprises an ultrasonic processing chamber 219 located within the mist generator housing 204.

[0197] Returning to Figures 14 and 15, the transducer holder 210 is configured to include a partition 220 that provides a barrier between the liquid chamber 218 and the ultrasonic processing chamber 219. The barrier provided by the partition 220 minimizes the risk of the ultrasonic processing chamber 219 overflowing with liquid from the liquid chamber 218, or the risk of the capillary elements on the ultrasonic transducer 215 becoming supersaturated, both of which would overload and reduce the efficiency of the ultrasonic transducer 215. Furthermore, overflowing the ultrasonic processing chamber 219 or supersaturating the capillary elements could also lead to the unpleasant experience of the user inhaling liquid during inhalation. To mitigate this risk, the partition 220 of the transducer holder 210 sits as a wall between the ultrasonic processing chamber 219 and the liquid chamber 218.

[0198] The partition 220 constitutes a capillary opening 221, which is the only means by which liquid can flow from the liquid chamber 218 to the ultrasonic treatment chamber 219 via a capillary element. In this example, the capillary opening 221 is an elongated slot having a width of 0.2 mm to 0.4 mm. The dimensions of the capillary opening 221 are such that the edges of the capillary opening 221 provide a bias force acting on the capillary extending through the capillary opening 221 to control the liquid flow into the ultrasonic treatment chamber 219.

[0199] In this example, the transducer holder 210 is made of liquid silicone rubber (LSR). In this example, the liquid silicone rubber has a hardness of Shore A 60. The LSR material ensures that the ultrasonic transducer 215 vibrates without the transducer holder 210 damping the vibrations. In this example, the vibration displacement of the ultrasonic transducer 215 is 2-5 nanometers, and any damping effect could reduce the efficiency of the ultrasonic transducer 215. Therefore, the material and hardness of this LSR are selected to obtain optimal performance with minimal compromise.

[0200] Referring next to Figures 16 and 17, the mist generator 201 includes a capillary tube or capillary element 222 for transferring a liquid (containing a drug or other substance) from the liquid chamber 218 to the ultrasonic treatment chamber 219. The tube element 222 is planar or substantially planar, having a first portion 223 and a second portion 224. In this example, the first portion 223 has a rectangular or substantially rectangular shape, and the second portion 224 has a partially circular shape.

[0201] In this example, the capillary element 222 consists of first and second parts 223 and 224 and third and fourth parts 225 and 226, which are the same shape as the first and second parts 223 and 224, respectively. In this example, the capillary element 222 is folded around the fold line 227 so that the first and second parts 223 and 224 and the third and fourth parts 225 and 226 overlap each other, as shown in Figure 17.

[0202] In this example, the capillary element has a thickness of approximately 0.28 mm. As shown in Figure 17, when the capillary element 222 is folded to have two layers, the overall thickness of the capillary element becomes approximately 0.56 mm. This double layer also ensures that there is always sufficient liquid on the ultrasonic transducer 215 for optimal aerosol generation.

[0203] In this example, when the capillary element 222 is folded, the lower ends of the first and third portions 223 and 225 define an enlarged lower end 228 that increases the surface area of ​​the portion of the capillary element 222 that is in the liquid within the liquid chamber 218 in order to maximize the rate at which the capillary element 222 absorbs the liquid.

[0204] In this example, capillary element 222 is 100% bamboo fiber. In other examples, the capillary elements are at least 75% bamboo fiber. The advantages of using bamboo fiber as a capillary element are as described above.

[0205] Referring now to Figures 18 and 19, the capillary element 222 is held by the transducer holder 210 such that the transducer holder 210 holds a second portion 224 of the capillary element 222 that is superimposed on a portion of the atomizing surface of the ultrasonic transducer 215. In this example, the circular second portion 224 is housed in an inner recess 214 of the transducer holder 210.

[0206] The first portion 223 of the capillary element 222 extends through the capillary opening 221 of the transducer holder 210.

[0207] Next, referring to Figures 20 to 22, the second part 206 of the mist generator housing 204 consists of a roughly circular wall 229 that receives the transducer holder 222 and forms part of the wall of the ultrasonic processing chamber 219.

[0208] Contact openings 230 and 231 are provided in the side walls of the second portion 206 to receive electrical contacts 232 and 233 that form an electrical connection with the electrodes of the ultrasonic transducer 215.

[0209] In this example, an absorbent tip or absorbent element 234 is provided adjacent to the mist outlet port 208 to absorb liquid at the mist outlet port 208. In this example, the absorbent element 234 is made of bamboo fiber.

[0210] Next, referring to Figures 23 to 25, the first part 205 of the mist generator housing 204 has a similar shape to the second part 206 and further comprises a generally circular wall portion 235 that forms a further part of the wall of the ultrasonic processing chamber 219 and holds the transducer holder 210.

[0211] In this example, an absorbent element 236 is further provided adjacent to the mist outlet port 208 to absorb liquid at the mist outlet port 208.

[0212] In this example, the first portion 205 of the mist generator housing 204 constitutes a spring support arrangement 237 that supports the lower end of the retainer spring 238, as shown in Figure 26.

[0213] The upper end of the retainer spring 238 contacts the second portion 224 of the capillary element 222 such that the retainer spring 238 provides a biasing force that biases the capillary element 222 toward the atomizing surface of the ultrasonic transducer 215.

[0214] Referring to Figure 27, it is shown that the transducer holder 210 is in place and held by the second part 206 of the mist generator housing 204 before the two parts 205 and 206 of the mist generator housing 204 are attached to each other.

[0215] Referring to Figures 28 to 31, in this example, the mist generator 201 is configured to include an identification array 239. The identification array 239 consists of a printed circuit board 240 having electrical contacts 241 on one side, and an integrated circuit 242 and another optional component 243 on the other side.

[0216] The integrated circuit 242 has a memory for storing an identifier unique to the mist generator 201. The electrical contact 241 provides an electronic interface for communicating with the integrated circuit 242.

[0217] In this example, the printed circuit board 240 is mounted in a recess 244 on one side of the mist generator housing 204. The integrated circuit 242 and any other electronic components 243 are housed in further recesses 245 such that the printed circuit board 240 is substantially flush with the side of the mist generator housing 204.

[0218] In this example, integrated circuit 242 is a one-time programmable (OTP) device, an anti-counterfeiting feature that ensures only genuine mist generators from the manufacturer are used with the device. This anti-counterfeiting feature is implemented in the mist generator 201 as a specific custom integrated circuit (IC) bonded to the mist generator 201 (and the printed circuit board 240). The OTP as an IC contains truly unique information that enables complete traceability of the mist generator 201 (and its contents) throughout its lifespan, as well as precise monitoring of consumption by the user. The OTP IC allows the mist generator 201 to function only when permitted.

[0219] An example implementation of the OTP IC in this disclosure is described in detail below.

[0220] The OTP (Authorized Technology Package) specifies the authorized status of a particular mist generator 201 as a characteristic feature. In fact, to prevent carbonyl emissions and maintain aerosol levels at a safe level, experiments have shown that after approximately 1000 seconds of aerosolization, the mist generator 201 is considered to have emptied the liquid in the liquid chamber 218. In this way, a non-genuine or empty mist generator 201 will be unable to operate after this predetermined usage time.

[0221] The OTP (One-Time Purchase) feature may be part of a complete chain involving the integration of the digital sales point, the mobile companion application, and the mist generator 201. Only genuine mist generators 201 manufactured by a trusted party and sold through the digital sales point may be used. The mobile companion digital app is a link between the user account on the manufacturer's digital platform and the mist generator 201, ensuring the safe use of known and secure content within a safe amount of puff duration.

[0222] Furthermore, the OTP functionality enables the high level of access control and monitoring required by pharmaceutical regulatory bodies when used in B2B (business-to-business) transactions with trusted medical facilities. The OTP IC is read by a driver device 202 that can recognize the inserted mist generator 201 and its associated prescription. The driver device 202 prevents the mist generator 201 from being used either longer or outside the period specified in the prescription. In addition, providing a mobile companion app reminder minimizes the chances of users missing their dose.

[0223] In some cases, the OTP IC is disposable, just like the mist generator 201. Whenever the mist generator 201 is considered empty, it will not be activated if inserted into the driver device 202. Similarly, a counterfeit generator device 201 will not function in the driver device 202.

[0224] Figures 32 to 34 show how air flows inside the mist generator 201 while it is in operation.

[0225] Liquid therapeutic agents (medical solutions, medical suspensions, protein solutions, supplements, etc.) are transformed into a mist (aerosolized) by ultrasonic treatment. However, this mist will settle on top of the ultrasonic transducer 215 if sufficient ambient air is not available to displace the rising aerosol. In the ultrasonic treatment chamber 219, a continuous supply of air is required because the mist (aerosol) is generated and drawn out to the user through a mouthpiece. To meet this requirement, an airflow channel is provided. In this example, the airflow channel is 11.5 mm 2 It has an average cross-sectional area, which is calculated based on the negative pressure from the average user and designed for the ultrasonic treatment chamber 219. This also controls the mist-to-air ratio of the inhaled aerosol and controls the amount of drug delivered to the user.

[0226] Based on the design requirements, the air flow path is routed to start from the bottom of the ultrasonic treatment chamber 219. The opening at the bottom of the aerosol chamber is aligned with and closely adjacent to the opening to the air flow bridge within the device. The air flow path runs vertically upward along the reservoir and continues to the center of the ultrasonic treatment chamber (concentric with the ultrasonic transducer 215). Here, it turns 90° inward. Then, the flow path continues to a point approximately 1.5 mm from the ultrasonic transducer 215. This path maximizes the ambient air directly supplied in the direction of the atomization surface of the ultrasonic transducer 215. Air flows through the channel towards the transducer, and while collecting the generated mist, exits through the mouthpiece to the user.

[0227] Next, the driver device 202 will be described first by referring to FIGS. 35 and 36. Air flows into the mist generating device 201 through the air inlet port 207 that is in fluid communication with the air flow bridge within the driver device 202 as will be described later. The air flows along a flow path that changes the direction of the air flow by approximately 90° to direct the air flow towards the ultrasonic transducer 215.

[0228] In some examples, the air flow arrangement is configured to change the direction of the air flow along the air flow path such that when the air flow passes through the ultrasonic treatment chamber, the air flow is substantially perpendicular to the atomization surface of the ultrasonic transducer.

[0229] The driver device 202 is at least partially composed of a driver device housing 246 made of metal. In some examples, the driver device housing 246 is entirely made of aluminum (AL6063 T6), protecting the internal components from the environment (dust, water splashes, etc.) and also from damage due to impacts (such as accidental drops).

[0230] In some examples, the driver device housing 246 has vents on its sides that allow ambient air to enter the device for two purposes. One provides ventilation around the electronic components to keep them within their operating temperature, and these vents also act as air inlets where air enters the device through these vents and then enters the mist generator 201 through the air flow bridge.

[0231] The driver device housing 246 has an elongated shape with an internal chamber 247 that houses the components of the driver device 202. One end of the driver device housing 246 is closed by an end cap 248. The other end of the driver device housing 247 has an opening 249 that provides an opening for the recess 203 of the driver device 202.

[0232] The driver device 202 is composed of a battery 250 connected to a printed circuit board 251. In some examples, the battery 250 is a 3.7V DC Li-Po battery with a capacity of 1140 mAh and a discharge rate of 10C. The high discharge rate is required for the maximum 15V voltage amplification required by the ultrasonic transducer 215 for desired operation. The shape and size of the battery are designed according to the shape and size of the device and the space allocated for the power supply within the range of physical constraints.

[0233] The printed circuit board 251 incorporates electronic components for realizing the electrical functions of the driver device 202, such as a processor and memory. The charging pin 258 is provided at one end of the printed circuit board 251, extends through the end cap 248, and provides a charging connection for charging the battery 250.

[0234] The printed circuit board 251 is held within the driver device housing 246 by a skeleton 252. The skeleton 252 has a channel 253 for receiving the printed circuit board 251. The skeleton 252 incorporates raised sides 254, 255 that support the battery 250.

[0235] In some cases, the skeleton 252 is manufactured using an industrial injection molding process. The molded plastic skeleton ensures that all components are secured and do not fit loosely within the case. It also forms a cover that surrounds the front portion of the PCB (Printed Circuit Board) when the mist generator 201 is inserted into the driver unit 202.

[0236] The driver unit 202 consists of an airflow sensor that functions as a switch to activate transducers for ultrasonic generation and aerosol generation and supply power. The airflow sensor is mounted on a PCB within the device, and a certain atmospheric pressure drop is required around it to operate the driver unit 202. For this purpose, an airflow bridge 259, as shown in Figures 39 to 41, is designed with internal channels 260, 261 that guide ambient air through the bridge 259 to the aerosol chamber 262. The frame 252 consists of opposing channels 256, 257 to receive a portion of the airflow bridge 259, as shown in Figure 42.

[0237] The internal channel of the airflow bridge 259 contains a microchannel 263 (0.5 mm in diameter) that extends toward a chamber 264 that completely encloses the airflow sensor. When air flows in from the side inlet and is directed upward into the aerosol chamber 262, a negative pressure is created in the microchannel 263, which triggers the airflow sensor to activate the device.

[0238] This device is a compact, portable, and advanced instrument capable of accurately and safely monitoring aerosolization. This is achieved by incorporating high-quality electronic components designed with IPC Class 3 (medical grade) standards in mind.

[0239] The electronic components of the driver unit 202 are divided as follows: 1. Ultrasonic Processing Unit For inhalation using portable devices, in order to achieve the most efficient aerosolization to date with a particle size of 1 μm or less, the ultrasonic processing unit must provide a contact pad that receives the ultrasonic transducer 215 (piezoelectric ceramic disc (PZT)) at a high adaptive frequency (approximately 3 MHz).

[0240] This section needs to provide not only high frequency but also consistently optimized cavitation while protecting the ultrasonic transducer 215 from failure.

[0241] The mechanical deformation of the PZT is linked to the amplitude of the AC voltage applied to it, and in order to ensure optimal system function and delivery with each ultrasonic irradiation, the maximum deformation must always be supplied to the PZT.

[0242] However, in order to prevent PZT failure, it is necessary to precisely control the active power transmitted to the PZT.

[0243] This is achieved only by designing a custom, power management integrated circuit (PMIC) chip that does not exist on the market, which is mounted on the printed circuit board of the driver device 202. This PMIC allows for instantaneous modulation of the active power supplied to the PZT without compromising the mechanical vibration amplitude of the PZT.

[0244] By applying PWM (Pulse Width Modulation) to the AC voltage applied to the PZT, the mechanical amplitude of the vibration can be kept constant.

[0245] Therefore, the only "off-the-shelf" option was to change the output AC voltage using a digital-to-analog converter (DAC). While this reduces the energy transferred to the PZT, it also causes mechanical deformation, completely hindering proper aerosolization. In fact, as with voltage modulation, the applied effective voltage remains the same with effective duty cycle modulation, but the active power transferred to the PZT degrades. This can be expressed by the following equation:

[0246]

Number

[0247] When considering the first harmonic, Irms is a function of the amplitude of the actual voltage applied to the transducer, and pulse width modulation controls Irms by varying the duration of the voltage supplied to the transducer.

[0248] The specific design of the PMIC adopts the most advanced design and includes a complete set of feedback loops and monitoring paths used by the control unit, enabling ultra-precise control of the frequency range and steps applied to the PZT.

[0249] The remaining part of the aerosolization section consists of a DC / DC boost converter and a transformer that supply the power required from the 3.7V battery to the PZT contact pads.

[0250] Referring now to FIG. 43 of the accompanying drawings, the driver device 202 consists of an ultrasonic transducer driver microchip, herein referred to as a power management integrated circuit or PMIC 300. The PMIC 300 is a microchip for driving a resonant circuit. The resonant circuit is an LC tank, an antenna, or, in this case, a piezoelectric transducer (ultrasonic transducer 215).

[0251] In the present disclosure, the terms chip, microchip, and integrated circuit are interchangeable. A microchip or integrated circuit is a single unit composed of a plurality of interconnected embedded components and subsystems. A microchip is, for example, at least partially made of a semiconductor such as silicon and is manufactured using semiconductor manufacturing technology.

[0252] The driver device 202 also includes a second microchip electrically connected to the PMIC 300, referred to herein as a bridge integrated circuit or bridge IC 301. The bridge IC 301 is a microchip for driving resonant circuits such as LC tanks, antennas, or piezoelectric transducers. The bridge IC 301 is a single unit composed of multiple interconnected embedded components or subsystems.

[0253] In this example, the PMIC300 and the bridge IC301 are mounted on the same board of the driver device 202. In this example, the physical dimensions of the PMIC300 are 1-3 mm in width and 1-3 mm in length, and the physical dimensions of the bridge IC301 are 1-3 mm in width and 1-3 mm in length.

[0254] The mist generator 201 comprises a programmable integrated circuit, a one-time programmable integrated circuit, or an OTP IC 242. When the mist generator 201 is coupled to the driver device 202, the OTP IC is electrically connected to the PMIC 300 and receives power from the PMIC 300 so that the PMIC 300 can manage the voltage supplied to the OTP IC 242. The OTP IC 242 is also connected to a communication bus 302 within the driver device 202. In this example, the communication bus 302 is an I2C bus, but in other examples, the communication bus 302 may be another type of digital serial communication bus.

[0255] The ultrasonic transducer 215 in the mist generator 201 is electrically connected to the bridge IC 301, and the ultrasonic transducer 215 can be driven by the AC drive signal generated by the bridge IC 301 when the device 200 is in use.

[0256] The driver device 202 consists of a processor in the form of a microcontroller 303 that is electrically coupled to the communication bus 302 in a communicative manner. In this example, the microcontroller 303 is Bluetooth TMThis is a low-energy (BLE) microcontroller. The microcontroller 303 receives power from a low-dropout regulator (LDO) 304, which is powered by a battery 250. The LDO 304 supplies a stable, regulated voltage to the microcontroller 303, ensuring stable operation even if the voltage of the battery 250 fluctuates.

[0257] The driver device 202 constitutes a voltage regulator in the form of a DC-DC boost converter 305 powered by the battery 250. The boost converter 305 increases the voltage of the battery 250 to a programmable voltage VBOOST. The programmable voltage VBOOST is set by the boost converter 305 in response to a voltage control signal VCTL from the PMIC 300. As will be described in detail later, the boost converter 305 outputs the voltage VBOOST to the bridge IC 301. In other examples, the voltage regulator is a buck converter or other type of voltage regulator that outputs a selectable voltage.

[0258] The voltage control signal (VCTL) in this example is generated by a digital-to-analog converter (DAC) implemented within the PMIC300. Because the DAC is integrated into the PMIC300, it is not visible in Figure 43. The DAC and the technical advantages of integrating it into the PMIC300 are described in detail below.

[0259] In this example, the PMIC 300 is connected to a power connector in the form of a Universal Serial Bus (USB) connector 306 so that the PMIC 300 can receive the charging voltage VCHRG when the USB connector 306 is plugged into a USB charger.

[0260] In this example, the driver device 202 consists of a first pressure sensor 307, which is a static pressure sensor. The driver device 202 also includes a second pressure sensor 308, which is a dynamic pressure sensor. However, in other examples, the driver device 202 consists of only one of the two pressure sensors 307, 308. As described above, the pressure sensors 307, 308 sense changes in pressure within the aerosol chamber 262 to detect when the user is inhaling from the mist inhaler 200.

[0261] In this example, the driver device 202 consists of multiple LEDs 308 controlled by the PMIC 300.

[0262] The microcontroller 303 functions as a master device on the communication bus 302, with the PMIC 300 as the first slave device, the OTP IC 242 as the second slave device, the second pressure sensor 308 as the third slave device, and the first pressure sensor 307 as the first slave device. The communication bus 302 allows the microcontroller 303 to control the following functions within the driver device 202.

[0263] 1. All functions of the PMIC are highly configurable by the microcontroller 303. 2. The current flowing through the ultrasonic transducer 215 is sensed at a high common-mode voltage (high-side of the bridge) by a high-bandwidth sense-rectifier circuit. The sensed current is converted to a voltage proportional to the effective current and provided as a buffered voltage to the current-sensing output terminal 309 of the bridge IC 301. This voltage is supplied to the PMIC 300 for sampling and made available as a digital representation via I2C requests. Sensing the current flowing through the ultrasonic transducer 215 forms part of the resonant frequency tracking function. The ability of the device to enable this functionality within the bridge IC 301, as described herein, provides a significant technical advantage. 3. The DAC integrated within the PMIC300 (not shown in Figure 43) allows the DC-DC boost converter voltage VBOOST to be programmed to be between 10V and 20V. 4. The microcontroller 303 enables the charger subsystem of the device 202 to manage the charging of the battery 250, which in this example is a single-cell battery. 5. A light-emitting diode (LED) driver module (not shown) drives the LED 308 in either linear mode or gamma correction mode and is powered by the PMIC 300 for digital dimming. 6. The microcontroller 303 can read the Pressure#1 and Pressure#2 sensor values ​​from the pressure sensors 307 and 308.

[0264] Referring here to Figure 44 of the attached drawings, the PMIC300 in this example is a self-contained chip or integrated circuit consisting of an integrated subsystem and a number of pins that provide electrical input and output to the PMIC300. References to integrated circuits or chips in this disclosure are interchangeable, and either term encompasses a semiconductor device, which may be silicon, for example.

[0265] The PMIC300 includes an analog core 310 which consists of analog components including a reference block (BG) 311, an LDO 312, a current sensor 313, a temperature sensor 314, and an oscillator 315.

[0266] As will be described in more detail below, oscillator 315 is coupled to a delay-locked loop (DLL) that outputs pulse-width modulation (PWM) phases A and B, and oscillator 315 and the DLL generate a two-phase center-matched PWM output that drives the H bridge in bridge IC 301.

[0267] A DLL consists of multiple end-to-end delay lines, the total delay time of which is equal to the period of the main clock signal clk_m. In this example, the DLL is implemented in a digital processor subsystem called the digital core 316 in this document, which receives a clock signal from oscillator 315 and a regulated power supply voltage from LDO 312. The DLL is implemented in the digital core 316 with a large number of delay gates (e.g., on the order of millions) connected end to end.

[0268] Currently, there are no signal generator components in the integrated circuit market that constitute this implementation, making it unique to implement the oscillator 315 and DLL on the same integrated circuit as the PMIC300 to generate a two-phase center-aligned PWM signal.

[0269] As described herein, PWM is part of the functionality that allows the driver device 202 to accurately track the resonant frequency of the ultrasonic transducer 215 in order to maintain an efficient transfer from electrical energy to kinetic energy in order to optimize mist generation.

[0270] In this example, the PMIC 300 is configured to include a charger circuit 317 that controls the charging of the battery 250 using power from, for example, a USB power source.

[0271] The PMIC300 is configured to include an integrated power switch VSYS that configures the PMIC300 to supply power to the analog core 310 by power from the battery 250, or by power from an external power supply if the battery 250 is charging.

[0272] The PMIC300 constitutes the embedded analog-to-digital converter (ADC) subsystem 318. The integration of the ADC318 together with the oscillator 315 within the same integrated circuit is unique in itself, as no other integrated circuits in the integrated circuit market exist that consist of an oscillator and ADC integrated as subblocks within an integrated circuit. In conventional devices, the ADC is supplied as a separate discrete component from the oscillator, and the ADC and oscillator are typically mounted on the same PCB. The problem with this conventional arrangement is that the two independent components, the ADC and oscillator, unnecessarily occupy space on the PCB. Furthermore, conventional ADCs and oscillators are usually connected to each other via serial data communication buses such as the I2C bus, which have the limitation of a maximum communication speed of 400 kHz. In contrast to conventional devices, the PMIC300 integrates the ADC318 and oscillator 315 within the same integrated circuit. This means there is no lag in communication between the ADC318 and oscillator 315, and the ADC318 and oscillator 315 can communicate with each other at high speed, for example, at the speed of the oscillator 315 (e.g., 3MHz to 5MHz).

[0273] In this example of the PMIC300, the oscillator 315 operates at 5 MHz and generates a 5 MHz clock signal, SYS CLOCK. However, in other examples, the oscillator 315 generates clock signals at much higher frequencies, up to 105 MHz. All integrated circuits described herein are configured to operate at higher frequencies of the oscillator 315.

[0274] The ADC318 consists of multiple feedback input terminals or analog inputs 319 that constitute multiple GPIO inputs (IF_GPIO1~3). At least one of the feedback input terminals or analog inputs 319 receives a feedback signal from the H-bridge circuit in the bridge IC301, which indicates the parameters of the operation of the H-bridge circuit or the parameters of the AC drive signal when the H-bridge circuit is driving a resonant circuit such as the ultrasonic transducer 215 with the AC drive signal. As will be described later, the GPIO inputs are used to receive current sensing signals from the bridge IC301 that indicate the root mean square (rms) current reported by the bridge IC301. In this example, one of the GPIO inputs is a feedback input terminal that receives a feedback signal from the H-bridge in the bridge IC301.

[0275] The ADC subsystem 318 samples the analog signals received by the multiple ADC input terminals 319 at a sampling frequency proportional to the frequency of the main clock signal. Then, the ADC subsystem 318 generates an ADC digital signal using the sampled analog signals.

[0276] In this example, the ADC318 built into the PMIC300 samples not only the RMS current flowing through the H-bridge 334 and ultrasonic transducer 215, but also the voltages available in the system (e.g., VBAT, VCHRG, VBOOST), the temperature of the PMIC300, the temperature of the battery 250, and GPIO inputs (IF_GPIO1~3) to enable future expansion.

[0277] The digital core 316 receives the ADC-generated digital signal from the ADC subsystem, processes the ADC digital signal, and generates a driver control signal. The digital core 316 transmits the driver control signal to the PWM signal generator subsystem (DLL332) and controls the PWM signal generator subsystem.

[0278] Rectifier circuits currently available on the market have very limited bandwidth (typically less than 1 MHz). Since the oscillator 315 of the PMIC300 operates at up to 5 MHz, or up to 105 MHz, a high-bandwidth rectifier circuit is implemented in the PMIC300. As described later, sensing the RMS current in the H-bridge of the bridge IC301 forms part of a feedback loop that enables the driver device 202 to drive the ultrasonic transducer 215 with high precision. This feedback loop is a game-changer in the ultrasonic transducer driving industry because it accommodates all process variations (variations in resonant frequency) in the manufacturing of piezoelectric transducers and compensates for the temperature effect of the resonant frequency. This is partially achieved by the inventive realization of integrating the ADC318, oscillator 315, and DLL within the same integrated circuit of the PMIC300. This integration allows these subsystems to communicate with each other at high speed (e.g., at clock frequencies of 5 MHz or up to 105 MHz). Reducing the lag between these subsystems is a game-changer in the ultrasonic industry, particularly in the field of mist generators.

[0279] The ADC318 consists of battery voltage monitoring input VBAT, charger input voltage monitoring input VCHG, as well as voltage monitoring inputs VMON and VRTH, and temperature monitoring input TEMP.

[0280] The temperature monitoring input TEMP receives a temperature signal from the temperature sensor 314 built into the PMIC 300. This allows the PMIC 300 to accurately sense the actual temperature inside the PMIC 300 and detect malfunctions within the PMIC 300, as well as malfunctions in other components on the printed circuit board that affect the temperature of the PMIC 300. The PMIC 300 can then control the bridge IC 301 to prevent excitation of the ultrasonic transducer 215 in the event of a malfunction, in order to maintain the safety of the mist inhaler 200.

[0281] The additional temperature sensor input VRTH receives a temperature sensing signal from an external temperature sensor in the driver unit 202, which monitors the temperature of the battery 250. Therefore, the PMIC 300 can react by stopping charging the battery 250 in the event of a high battery temperature, or otherwise shutting down the driver unit 202, in order to reduce the risk of damage caused by excessively high battery temperatures.

[0282] In this example, the PMIC300 consists of an LED driver 320 that receives a digital drive signal from the digital core 316 and provides LED drive output signals to six LEDs 321-326, which are configured to be coupled to the output pins of the PMIC300. Thus, the LED driver 320 can drive and dim the LEDs 321-326 on up to six independent channels.

[0283] The PMIC300 includes a first digital-to-analog converter (DAC) 327 that converts the digital signals within the PMIC300 into analog voltage control signals and outputs them from the PMIC300 via the output terminal VDAC0. The first DAC327 converts the digital control signals generated by the digital core 316 into analog voltage control signals and outputs them via the output terminal VDAC0 to control voltage regulator circuits such as the boost converter 305. In this way, the voltage control signals control the voltage regulator circuits to generate a predetermined voltage for modulation by an H-bridge circuit to drive the resonant circuit (ultrasonic transducer 215) in response to a feedback signal indicating the operation of the resonant circuit (ultrasonic transducer 215).

[0284] In this example, the PMIC300 is configured to include a second DAC328 that converts the digital signals within the PMIC300 into analog signals output from the PMIC300 via a second analog output terminal VDAC1.

[0285] By embedding DAC327 and 328 within the same microchip as the other subsystems of the PMIC300, DAC327 and 328 can communicate with the digital core 316 and other components within the PMIC300 with little to no communication lag and at high speed. DAC327 and 328 provide analog outputs to control external feedback loops. For example, the first DAC327 supplies a control signal VCTL to the boost converter 305, controlling its operation. In another example, DAC327 and 328 are configured to supply a drive signal to a DC-DC buck converter, either instead of or in addition to the boost converter 305. By integrating two independent DAC channels into the PMIC300, the PMIC300 can manipulate the feedback loop of any regulator used by the driver device 202, allowing the driver device 202 to adjust the ultrasonic irradiation power of the ultrasonic transducer 215 or set analog thresholds for the absolute maximum current and temperature settings of the ultrasonic transducer 215.

[0286] The PMIC300 configures a serial communication interface, which in this example is an I2C interface with an internal external I2C address configured via a pin.

[0287] The PMIC300 also consists of various functional blocks, including a Digital Machine Module (FSM) for implementing the functions of the microchip. These blocks are described in more detail below.

[0288] Referring to Figure 45 in the attached diagram, the pulse width modulation (PWM) signal generator subsystem 329 is integrated into the PMIC 300. The PWM generator system 329 consists of an oscillator 315, a frequency divider 330, a multiplexer 331, and a delay-locked loop (DLL) 332. As will be described later, the PWM generator system 329 is a two-phase center-aligned PWM generator.

[0289] The frequency divider 330, multiplexer 331, and DLL 332 are implemented using digital logic components (e.g., transistors, logic gates, etc.) within the digital core 316.

[0290] In the examples of this disclosure, the frequency range covered by the oscillator 315 and the PWM generation system 329, respectively, is 50 kHz to 5 MHz or up to 105 MHz. The frequency accuracy of the PWM generation system 329 is ±1%, and its temperature overhang is ±1%. Currently, there are no ICs on the IC market that incorporate an oscillator and a two-phase center-matched PWM generator capable of providing a frequency range of 50 kHz to 5 MHz or 105 MHz.

[0291] Oscillator 315 generates a main clock signal (clk_m) with a frequency of 50kHz to 5MHz or up to 105MHz. The main clock clk_m is input to frequency divider 330, which divides the frequency of the main clock clk_m by one or more predetermined divisors. In this example, frequency divider 330 divides the frequency of the main clock clk_m by 2, 4, 8, and 16, and supplies the divided frequency clocks as outputs to multiplexer 331. Multiplexer 331 multiplexes the divided frequency clocks and supplies the divided frequency outputs to DLL332. The signal passed to DLL332 is a frequency reference signal that controls DLL332 to output signals at the desired frequency. In other examples, frequency divider 330 and multiplexer 331 are omitted.

[0292] Furthermore, oscillator 315 generates two phases: a first-phase clock signal (phase 1) and a second-phase clock signal (phase 2). The phases of the first-phase and second-phase clock signals are center-aligned, as shown in Figure 46: The first phase clock signal, phase 1, is high for a variable time corresponding to the positive half-period of clk_m, and low during the negative half-period of clk_m. The second phase clock signal, phase 2, is high for a variable time corresponding to the negative half-period of clk_m, and low for the positive half-period of clk_m.

[0293] The first-phase clock signal (phase 1) and the second-phase clock signal (phase 2) are then used to generate a double-frequency clock signal in DLL332. This double-frequency clock signal has twice the frequency of the main clock signal clk_m. In this example, an "OR" gate in DLL332 uses the first-phase clock signal (phase 1) and the second-phase clock signal (phase 2) to generate a double-frequency clock signal. This double-frequency clock, or the divided frequency coming from the frequency divider 330, is selected based on the chosen target frequency and then used as the reference for DLL332.

[0294] Within the DLL332, the signal referred to as "clock" represents twice the main clock clk_m, and the signal referred to as "clock_del" represents a replica of the clock delayed by one cycle. Both clock and clock_del pass through a phase frequency detector. Based on the polarity of the phase error, node Vc is charged and discharged by a charge pump. A control voltage is directly supplied to control the delay of each delay unit within the DLL332 until the total delay of the DLL332 is exactly one cycle.

[0295] The DLL332 controls the rising edges of the first phase clock signal (phase 1) and the second phase clock signal (phase 2) to synchronize with the rising edges of the double-frequency clock signal. The DLL332 adjusts the frequency and duty cycle of the first phase clock signal (phase 1) and the second phase clock signal (phase 2) according to their respective frequency reference and duty cycle control signals, generating the first phase output signal (phase A) and the second phase output signal (phase B) to drive the H-bridge or inverter and generate the AC drive signal to drive the ultrasonic transducer.

[0296] The PMIC300 consists of a first-phase output signal terminal PHASE_A, which outputs the first-phase output signal phase A to the H-bridge circuit, and a second-phase output signal terminal PHASE_B, which outputs the second-phase output signal phase B to the H-bridge circuit.

[0297] In this example, the DLL332 changes the delay time of each delay line in the DLL332 in response to the duty cycle control signal, thereby controlling the first phase clock signal phase Adjust the duty cycle of the Phase 2 clock signal for Phases 1 and 2.

[0298] The clock is used at twice its frequency to ensure better accuracy. As shown in Figure 47, if the frequency of the main clock clk_m is used for illustrative purposes (not used in the examples of this disclosure), Phase A is synchronized to the rising edge R of the clock and Phase B is synchronized to the falling edge F of the clock. The delay line of DLL332 controls the rising edge R, and therefore, for the falling edge F, the PWM generation system 329 would have to rely on a perfect match of the delay unit of DLL332, which could be imperfect. However, to eliminate this error, the PWM generation system 329 uses a double-frequency clock so that both Phase A and Phase B are synchronized to the rising edge R of the double-frequency clock.

[0299] To execute duty cycles from 20% to 50% in 2% step sizes, the DLL332 delay line consists of 25 delay units, with the output of each delay unit representing phase n. Ultimately, the phase of the output of the last delay unit corresponds to the input clock. Assuming all delays are approximately the same, a specific duty cycle can be obtained at the output of a specific delay unit using the simple logic of the digital core 316.

[0300] While DLL332 may not be able to lock onto a delay period, having two or more periods can lead DLL332 into a non-converging zone, so care must be taken when activating DLL332. To circumvent this problem, an activation circuit is implemented in the PWM generation system 329, which allows DLL332 to be activated from a known deterministic state. The activation circuit further enables DLL332 to be activated with minimal delay.

[0301] In the example of this disclosure, the frequency range covered by the PWM generator system 329 is extended so that the delay unit in DLL332 can provide delays of 4 ns (for an oscillator frequency of 5 MHz) to 400 ns (for an oscillator frequency of 50 kHz). To accommodate these different delays, a capacitor Cb is included in the PWM generator system 329, and the capacitor value is selected to provide the required delay.

[0302] Phases A and B are output from DLL332 and passed to bridge IC301 via digital I / O, making phases A and B available for operation control of bridge IC301.

[0303] Next, the battery charging function of the driver device 202 will be described in more detail. The battery charging subsystem consists of a charger circuit 317, which is built into the PMIC 300 and controlled by a digital charge controller hosted in the PMIC 300. The charger circuit 317 is controlled by a microcontroller 303 via a communication bus 302. The battery charging subsystem is capable of charging single-cell lithium polymer (LiPo) or lithium-ion (Li-ion) batteries, such as the battery 250 described above.

[0304] In this example, the battery charging subsystem can charge a battery or a battery with a maximum charging current of 1A from a 5V power supply (e.g., a USB power supply). The battery charging parameters can be adapted by programming one or more of the following parameters via the communication bus 302 (I2C interface).

[0305] The charging voltage can be set in 100mV steps between 3.9V and 4.3V.

[0306] The charging current can be set in 50mA increments from 150mA to 1000mA.

[0307] The pre-charge current is 1 / 10 of the charging current.

[0308] The timeouts for pre-charge and fast charge are 5-85 minutes and 20-340 minutes, respectively. It can be set between [values].

[0309] As an option, the battery temperature can be monitored using an external negative temperature coefficient (NTC) thermistor.

[0310] In some examples, the battery charging subsystem reports one or more of the following events by generating an interrupt to the host microcontroller 303: Battery detection Battery charging The battery is fully charged. No battery Charging timeout The charging power supply is below the insufficient voltage limit.

[0311] The main advantage of embedding the charger circuit 317 in the PMIC 300 is that all the programming options and event displays described can be implemented within the PMIC 300, ensuring the safe operation of the battery charging subsystem. Furthermore, it is possible to achieve significant savings in manufacturing costs and PCB space compared to conventional mist inhalers consisting of discrete components of the charging system that are separately implemented on the PCB. In addition, the charger circuit 317 allows for versatile settings of charging current and voltage, different fault timeouts, and numerous event flags for detailed state analysis.

[0312] Next, the analog-to-digital converter (ADC) 318 will be described in more detail. The inventors had to overcome significant technical challenges to integrate the ADC 318 into the PMIC 300, which has a high-speed oscillator 315. Furthermore, integrating the ADC 318 into the PMIC 300 goes against conventional approaches in the art that rely on using one of the many discrete ADC devices available on the IC market.

[0313] In this example, the ADC318 samples at least one parameter within the ultrasonic transducer driver chip (PMIC300) at a sampling rate equal to the frequency of the main clock signal clk_m. In this example, the ADC318 is a 10-bit analog-to-digital converter that can unload digital sampling from the microprocessor 303 to conserve resources on the microprocessor 303. Integrating the ADC318 within the PMIC300 also avoids the need to use an I2C bus, which would otherwise slow down the ADC's sampling capability (traditional devices rely on an I2C bus to transmit data between a dedicated discrete ADC and a microcontroller, typically at a limited clock speed of up to 400 kHz).

[0314] In the examples of this disclosure, one or more of the following parameters may be sequentially sampled by the ADC318.

[0315] i. The RMS current signal received by the ultrasonic transducer driver chip (PMIC300) from the external inverter circuit driving the ultrasonic transducer. In this example, this parameter is the root mean square (rms) current reported by the bridge IC301. Sensing the RMS current is crucial for implementing the feedback loop used to drive the ultrasonic transducer 215. The ADC318 does not rely on this information being transmitted over the I2C bus, so it is possible to sense the RMS current directly from the bridge IC301 via a signal with minimal or no delay. This provides significant speed and accuracy advantages compared to conventional devices, which are limited by the relatively low speed of the I2C bus. ii. The voltage of the battery connected to the PMIC300. iii. The voltage of the charger connected to the PMIC300. iv. Temperature signal indicating the chip temperature of the PMIC300, etc. As mentioned above, since the temperature sensor 314 is built into the same IC as the oscillator 315, this temperature can be measured with great accuracy. For example, if the temperature of the PMIC300 rises, the PMIC300 controls the current, frequency, and PWM, which in turn controls the oscillation of the transducer, thereby controlling the temperature. v. Two external terminals. vi. External NTC temperature sensor for monitoring the battery pack temperature.

[0316] In some examples, the ADC318 sequentially samples one or more of the above sources, for example, in a round-robin manner. The ADC318 samples the sources at a high speed, such as the speed of the oscillator 315, which may be up to 5 MHz or up to 105 MHz.

[0317] In some examples, device 202 is configured to allow the user or device manufacturer to specify how many samples to take from each source for averaging. For example, the user can configure the system to take 512 samples from the RMS current input, 64 samples from the battery voltage, 64 samples from the charger input voltage, 32 samples from the external pin, and 8 samples from the NTC pin. Furthermore, the user can also specify whether to skip one of the above sources.

[0318] In some examples, the user can specify two digital thresholds for each source, dividing the entire range into multiple zones (e.g., three zones). An interrupt can then be configured to occur when the sampled value changes from zone 2 to zone 3.

[0319] Conventional ICs currently available on the market cannot perform the functions described above for the PMIC300. Such flexibility and granularity in sampling are crucial when driving resonant circuits or components, such as ultrasonic transducers.

[0320] In this example, the PMIC300 consists of 8-bit general-purpose digital input / output ports (GPIO). Each port can be configured as a digital input and a digital output. Additionally, as shown in the table in Figure 48, some ports also have analog input capabilities.

[0321] The GPIO7-GPIO5 ports of the PMIC300 can be used to address devices on the I2C bus 302. Subsequently, eight identical devices can be used on the same I2C bus. This is a unique feature in the IC industry because it allows eight identical devices to be used on the same I2C bus without address conflicts. This is achieved by each device reading the state of GPIO7-GPIO5 during the first 100μs after the PMIC300 starts up, and storing the addresses of that portion internally in the PMIC300. After the PMIC300 starts up, the GPIOs can be used for other purposes.

[0322] As described above, the PMIC300 is configured to include a 6-channel LED driver 320. In this example, the LED driver 320 is composed of a 5V withstand voltage N-Channel Metal-Oxide Semiconductor (NMOS) current source. The LED driver 320 is configured to allow setting the LED current to four discrete levels: 5mA, 10mA, 15mA, and 20mA. The LED driver 320 is configured to dim each LED channel with a 12-bit PWM signal, with or without gamma correction. The LED driver 320 is configured to vary the PWM frequency between 300Hz and 1.5KHz. This feature is unique in the field of ultrasonic mist inhalers because it is integrated as a subsystem of the PMIC300.

[0323] In this example, the PMIC300 consists of two independent 6-bit digital-to-analog converters (DACs) 327 and 328 integrated into the PMIC300. The purpose of DACs 327 and 328 is to output analog voltages to manipulate the feedback path of an external regulator (e.g., DC-DC boost converter 305, buck converter, or LDO). Furthermore, in some examples, DACs 327 and 328 can also be used to dynamically adjust the overcurrent shutdown level of the bridge IC 301, as described later.

[0324] The output voltage of each DAC327 and 328 is programmable between 0V and 1.5V, or between 0V and V_battery (Vbat). In this example, the DAC output voltage is controlled via I2C commands. The incorporation of two DACs into the PMIC300 is unique, enabling dynamic monitoring and control of the current. If either the DAC327 or 328 were an external chip, it would be subject to the same limitations as the speed limit imposed by the I2C protocol. With all these built-in functions within the PMIC, the active power monitoring arrangement of device 202 functions with optimal efficiency. If these were external components, the active power monitoring arrangement would be completely inefficient.

[0325] Referring here to Figure 49 of the attached drawings, the bridge IC 301 is a microchip that constitutes the embedded power switching circuit 333. In this example, the power switching circuit 333 is the H-bridge 334 shown in Figure 50, which will be described in detail below. However, it will be understood that in other examples, the bridge IC 301 may incorporate a power switching circuit that performs an equivalent function for generating the AC drive signal to drive the ultrasonic transducer 215, instead of the H-bridge 334.

[0326] Bridge IC 301 constitutes the first phase terminal Phase A, which receives the first phase output signal Phase A from the PWM signal generation subsystem of PMIC 300. Bridge IC 301 also constitutes the second phase terminal Phase B, which receives the second phase output signal Phase B from the PWM signal generator subsystem of PMIC 300.

[0327] The bridge IC 301 consists of a current sensing circuit 335 that directly senses the current flow in the H-bridge 334 and provides an RMS current output signal via the RMS_CURR terminal of the bridge IC 301. The current sensing circuit 335 is configured for overcurrent monitoring, detecting when the current flowing through the H-bridge 334 exceeds a predetermined threshold. Integrating all of the power switching circuit 333 and current sensing circuit 335 that constitute the H-bridge 334 into the same embedded circuit of the bridge IC 301 is a unique combination in the IC market. Currently, there are no other integrated circuits in the IC market that constitute an H-bridge with an embedded circuit for sensing the RMS current flowing through the H-bridge.

[0328] The bridge IC 301 comprises a temperature sensor 336, which includes over-temperature monitoring. The temperature sensor 336 is configured to shut down the bridge IC 301 or disable at least a portion of the bridge IC 336 if it detects that the bridge IC 301 is operating at a temperature exceeding a predetermined threshold. Thus, the temperature sensor 336 provides an integrated safety function to prevent damage to the bridge IC 301 or other components in the driver device 202 if the bridge IC 301 operates at an excessively high temperature.

[0329] The bridge IC 301 comprises a digital state machine 337 integrally connected to the power switching circuit 333. The digital state machine 337 receives phase A and phase B signals from the PMIC 300 and, for example, an ENABLE signal from the microcontroller 303. The digital state machine 337 generates timing signals based on the first phase output signal phase A and the second phase output signal phase B.

[0330] The digital state machine 337 controls the power switching circuit 333 by receiving timing signals corresponding to the phase A signal and the phase B signal, as well as BRIDGE PR signal and BRIDGE The EN signal is output to the power switching circuit 333. As a result, the digital state machine 337 switches the H-bridge circuit 334. Timing signals are output to T1-T4, controlling switches T1-T4 to turn on / off sequentially so that the H-bridge circuit outputs AC drive signals to drive resonant circuits such as the ultrasonic transducer 215.

[0331] As will be explained in more detail later, the switching sequence consists of a free-float period in which the first switch T1 and the second switch T2 are turned off and the third switch T3 and the fourth switch T4 are turned on in order to dissipate the energy stored in the resonant circuit (ultrasonic transducer 215).

[0332] The bridge IC 301 is configured to include a test controller 338 that can test the bridge IC 301 to determine whether the embedded components within the bridge IC 301 are functioning correctly. DATA, TEST CLK, TEST It is connected to the LOAD terminal, allowing data to be sent to the bridge IC 301 and connected to an external control device to test the operation of the bridge IC 301. The bridge IC 301 also has a TST (Transmission Stability Test) function. A TEST BUS is configured that allows testing of the digital communication bus within the bridge IC301 via the PAD terminal.

[0333] The bridge IC 301 includes a power-on reset circuit (POR) 339 that controls the startup operation of the bridge IC 301. The POR 339 ensures that the bridge IC 301 starts up normally only when the power supply voltage is within a predetermined range. If the power supply voltage is outside the predetermined range, for example, if the power supply voltage is too high, the POR 339 delays the startup of the bridge IC 301 until the power supply voltage comes within the predetermined range.

[0334] The bridge IC 301 comprises a reference block (BG) 340 that provides a precise reference voltage for use by other subsystems of the bridge IC 301.

[0335] The bridge IC 301 constitutes a current reference 341 that provides accurate current to power switching circuits 333 and / or other subsystems within the bridge IC 301, such as the current sensor 335.

[0336] The temperature sensor 336 continuously monitors the silicon temperature of the bridge IC 301. If the temperature exceeds a predetermined temperature threshold, the power switching circuit 333 is automatically switched off. Furthermore, the overheating may be reported to an external host to notify the external host that an overheating event has occurred.

[0337] The digital state machine (FSM) 337 generates timing signals for the power switching circuit 333, which in this example are timing signals for controlling the H-bridge 334.

[0338] The bridge IC 301 consists of comparators 342 and 343 that compare signals from various subsystems of the bridge IC 301 with voltage and current references 340 and 341, and provide reference output signals via the pins of the bridge IC 301.

[0339] Referring again to Figure 50 of the attached drawings, the H-bridge 334 in this example consists of four switches in the form of NMOS field-effect transistor (FET) switches on both sides of the H-bridge 334. The H-bridge 334 is connected in an H-bridge configuration. It consists of four switches or transistors T1-T4, each of which is driven by its respective logic inputs A-D. Transistors T1-T4 are configured to be driven by an internally generated bootstrap voltage using two external capacitors Cb connected as shown in Figure 50.

[0340] The H-bridge 334 configures the input and output of various power supplies connected to each pin of the bridge IC 301. The H-bridge 334 receives the programmable voltage VBOOST output from the boost converter 305 via the first power supply terminal labeled VBOOST in Figure 50. The H-bridge 334 also constitutes the second power supply terminal labeled VSS_P in Figure 50.

[0341] The H-bridge 334 has outputs OUTP and OUTN configured to be connected to the respective terminals of the ultrasonic transducer 215 so that the AC drive signals output from the H-bridge 334 can drive the ultrasonic transducer 215.

[0342] The switching of the four switches or transistors T1-T4 is controlled by switching signals from the digital state machine 337 via logic inputs A-D. While Figure 50 shows the four transistors T1-T4, it should be understood that in other examples, the H-bridge 334 incorporates more transistors or other switching components to achieve the functions of an H-bridge.

[0343] In this example, the H-bridge 334 operates with switching power of 22W to 50W to supply an AC drive signal with sufficient power to drive the ultrasonic transducer 215 and generate optimal mist. The voltage that the H-bridge 334 switches in this example is ±15V, but in other examples it is ±20V.

[0344] In this example, the H-bridge 334 switches at frequencies from 3 MHz to 5 MHz, or up to 105 MHz. This represents a high switching speed compared to conventional integrated circuit H-bridges available on the IC market. For example, conventional integrated circuit H-bridges currently available on the IC market are configured to operate at a maximum frequency of only 2 MHz. Apart from the bridge IC 301 described herein, there are no conventional integrated circuit H-bridges available on the IC market that can operate at frequencies up to 5 MHz, let alone up to 105 MHz, at power levels of 22V to 50V.

[0345] Next, referring to Figure 51 of the attached drawings, the current sensor 335 is as shown in Figure 50. The H-bridge 334 consists of positive and negative current-sensing resistors RshuntP and RshuntN connected in series with the respective high and low sides. In this example, the current-sensing resistors RshuntP and RshuntN have low resistances of 0.1 Ω. The current sensor 335 consists of a first voltage sensor in the form of a first operational amplifier 344 that measures the voltage drop across the first current-sensing resistor RshuntP, and a second voltage sensor in the form of a second operational amplifier 345 that measures the voltage drop across the second current-sensing resistor RshuntN. In this example, the gain of each operational amplifier 344 and 345 is 2V / V. The output of each operational amplifier 344 and 345 is 1mA / V in this example. The current sensor 335 is connected to a pull-down resistor R cs It consists of a resistor, which in this example is 2kΩ. The outputs of op-amps 344 and 345 provide an output CSout that has passed through a low-pass filter 346 to remove transients of the signal CSout. The output Vout of the low-pass filter 346 is the output signal of the current sensor 335.

[0346] In this way, the current sensor 335 measures the alternating current flowing through the H-bridge 334 and, in each case, through the ultrasonic transducer 215. The current sensor 335 converts the alternating current into an equivalent RMS output voltage (Vout) relative to ground. Since the H-bridge 334 can be operated at frequencies up to 5 MHz, or up to 105 MHz in some examples, the current sensor 335 has high bandwidth capability. The output Vout of the current sensor 335 reports a positive voltage corresponding to the measured effective alternating current flowing through the ultrasonic transducer 215. In this example, the output voltage Vout of the current sensor 335 is fed back to the control circuit in the bridge IC 301, allowing the bridge IC 301 to shut down the H-bridge 334 if the current flowing through the H-bridge 334, and consequently the current flowing through the transducer 215, exceeds a predetermined threshold. Furthermore, an overcurrent threshold event causes the bridge IC 301 to shut down the OVC of the bridge IC 301. The overcurrent event is reported to the first comparator 342 of the bridge IC 301 via the TRIGG pin.

[0347] Next, referring to Figure 52 in the attached drawings, the control of the H-bridge 334 will be explained, with reference to the equivalent piezoelectric model of the ultrasonic transducer 215.

[0348] As shown in V_out in Figure 52, the switching sequence of transistors T1-T4 via inputs A-D to generate a positive voltage across the outputs OUTP and OUTN of the H-bridge 334 (note the direction of the arrows) is as follows: 1. Positive output voltage across ultrasonic transducer 215: A - On, B - Off, C - Off, D - On 2. Transition from positive output voltage to zero: A - off, B - off, C - off, D - on. During this transition, if there is a switching error or delay in A, C is switched off first to minimize or avoid power loss by minimizing or avoiding the current flowing through A and C. 3. Zero Output Voltage: A-OFF, B-OFF, C-ON, D-ON. In this zero output voltage phase, the OUTP and OUTN terminals of the H-bridge 334 are grounded by the C and D switches, which remain ON. This dissipates the energy stored in the capacitors of the ultrasonic transducer's equivalent circuit, minimizing the voltage overshoot of the switching waveform voltage applied to the ultrasonic transducer. 4. Transition from zero to negative output voltage: A-OFF, B-OFF, C-ON, D-OFF. 5. Negative output voltage across ultrasonic transducer 215: A-OFF, B-ON, C-ON, D-OFF.

[0349] At high frequencies of up to 5 MHz or even 105 MHz, it will be understood that the duration of each part of the switching sequence is extremely short, on the order of nanoseconds or picoseconds. For example, at a switching frequency of 6 MHz, each part of the switching sequence occurs in approximately 80 nanoseconds.

[0350] Figure 53 in the attached diagram shows graphs illustrating the output voltages OUTP and OUTN of the H-bridge 334 due to the switching sequence described above. The zero output voltage portion of the switching sequence is included to correspond to the energy stored by the ultrasonic transducer 215 (for example, the energy stored by the capacitor in the equivalent circuit of the ultrasonic transducer). As described above, this minimizes the voltage overshoot of the switching waveform voltage applied to the ultrasonic transducer, thereby minimizing unwanted power dissipation and heating in the ultrasonic transducer.

[0351] Furthermore, by minimizing or eliminating voltage overshoot, it is possible to prevent the transistors in the bridge IC 301 from receiving voltages exceeding their rated voltage, thereby reducing the risk of transistor damage. In addition, minimizing or eliminating voltage overshoot enables the bridge IC 301 to accurately drive the ultrasonic transducer in a manner that minimizes the breakdown of the current-sensing feedback loop described herein. As a result, the bridge IC 301 can drive the ultrasonic transducer at high power levels of 22W to 50W or 70W at high frequencies up to 5MHz or up to 105MHz.

[0352] The bridge IC301 in this example is controlled by the PMIC300 and is configured to operate in two different modes, referred to in this document as forced mode and native frequency mode. These two operating modes are novel compared to existing bridge ICs. In particular, native frequency mode is a major innovation that provides substantial advantages in the accuracy and efficiency of driving ultrasonic transducers compared to conventional equipment.

[0353] Forced Frequency Mode (FFM) In forced frequency mode, the H-bridge 334 is controlled in the order described above, but at a frequency selectable by the user. As a result, the H-bridge transistors T1-T4 are forcibly controlled independently of the intrinsic resonant frequency of the ultrasonic transducer 215, switching the output voltage across the ultrasonic transducer 215. Thus, in forced frequency mode, the H-bridge 334 can drive the ultrasonic transducer 215, which has a resonant frequency f1, at different frequencies f2.

[0354] Driving an ultrasonic transducer at a frequency different from its resonant frequency may be appropriate to adapt its operation to different applications. For example, it may be appropriate to drive an ultrasonic transducer at a frequency slightly deviated from its resonant frequency (for mechanical reasons to prevent mechanical damage to the transducer). Alternatively, it may be appropriate to drive an ultrasonic transducer at a lower frequency, but ultrasonic transducers have different inherent resonant frequencies due to their size.

[0355] The driver device 202 controls the bridge IC 301 to drive the ultrasonic transducer 215 in forced frequency mode, depending on the configuration of the driver device 202 for a specific application or a specific ultrasonic transducer. For example, the driver device 202 may be configured to operate in forced frequency mode if the mist inhaler 200 is used in a specific application such as generating a mist from a liquid of a certain viscosity containing a drug to be delivered to the user.

[0356] Native frequency mode (NFM) The following native frequency mode operation represents a significant development, offering advantages in terms of improved accuracy and efficiency compared to conventional ultrasonic drivers currently available on the IC market.

[0357] Native frequency mode operation follows the same switching sequence as described above, but the timing of the zero-output portion of the sequence is adjusted to minimize or avoid problems that may arise due to current spikes in forced frequency mode operation. These current spikes occur when the voltage across the ultrasonic transducer 215 switches to the opposite voltage polarity. An ultrasonic transducer made of a piezoelectric crystal has an electrical equivalent circuit incorporating a parallel-connected capacitor (see, for example, the piezo model in Figure 52). When the voltage across the ultrasonic transducer is hard-switched from a positive voltage to a negative voltage, a large current flow can occur as the energy stored in the capacitor dissipates due to the high dV / dt.

[0358] The native frequency mode avoids hard-switching the voltage across the ultrasonic transducer 215 from positive to negative (and vice versa). Instead, before applying the inverting voltage, the ultrasonic transducer 215 (piezoelectric crystal) is left in a free-float state with a zero voltage applied across its terminals for a free-float period. The PMIC 300 sets the drive frequency of the bridge IC 301 so that the bridge 334 causes the current flowing inside the ultrasonic transducer 215 during the free-float period (due to the energy stored in the piezoelectric crystal) to invert the voltage across the terminals of the ultrasonic transducer 215.

[0359] As a result, when the H-bridge 334 applies a negative voltage to the terminals of the ultrasonic transducer 215, the ultrasonic transducer 215 (the capacitor in the equivalent circuit) is already reverse-charged, and since there is no high dV / dt, no current spike occurs.

[0360] However, it should be understood that when the ultrasonic transducer 215 is first activated, it takes time for the charge within the ultrasonic transducer 215 (piezoelectric crystal) to accumulate. Therefore, the ideal situation in which the energy within the ultrasonic transducer 215 reverses the voltage during the free-float period only occurs after the oscillation within the ultrasonic transducer 215 has accumulated charge. To address this, when the bridge IC 301 first starts the ultrasonic transducer 215, the PMIC 300 controls the power supplied to the ultrasonic transducer 215 via the H-bridge 334 to a low value, a first value (e.g., 5V). Then, the PMIC 300 controls the power supplied to the ultrasonic transducer 215 via the H-bridge 334 to increase over a period of time to a second value (e.g., 15V) higher than the first value, in order to build up the energy accumulated within the ultrasonic transducer 215. Current spikes also occur during this ramp of oscillation until the current inside the ultrasonic transducer 215 is sufficiently developed. However, by using a low first voltage at startup, these current spikes can be kept sufficiently low, minimizing their impact on the operation of the ultrasonic transducer 215.

[0361] To achieve native frequency mode, the driver unit 202 precisely controls the frequency of the oscillator 315 and the duty cycle (ratio of turn-on time to free-float time) of the AC drive signal output from the H-bridge 334. In this example, the driver unit 202 implements three control loops to adjust the oscillator frequency and duty cycle to ensure the most accurate voltage inversion at the terminals of the ultrasonic transducer 215 and to minimize or avoid current spikes. Precise control of the oscillator and duty cycle using control loops represents a significant advance in the field of IC ultrasonic drivers.

[0362] During operation in native frequency mode, the current sensor 335 senses the current flowing through the ultrasonic transducer 215 (resonant circuit) during the free-float period. When the digital state machine 337 senses that the current flowing through the ultrasonic transducer 215 (resonant circuit) is zero during the free-float period, it adjusts the timing signal to turn on either the first switch T1 or the second switch T2.

[0363] Figure 54 in the attached drawing shows the oscillator voltage waveform 347 (V(osc)), the switching waveform 348 due to the turn-on and turn-off of the left high switch T1 of the H bridge 334, and the switching waveform 349 due to the turn-on and turn-off of the right high switch T2 of the H bridge 334. During the free float period 350, both high switches T1 and T2 of the H bridge 334 are turned off (free float phase). The duration of the free float period 350 is controlled by the magnitude of the free float control voltage 351 (Vphioff).

[0364] Figure 55 in the attached drawing shows the voltage waveform 352 at the first terminal of the ultrasonic transducer 215 (the voltage waveform is inverted at the second terminal of the ultrasonic transducer 215) and the piezoelectric current 353 flowing through the ultrasonic transducer 215. The piezoelectric current 353 represents a (nearly) ideal sinusoidal waveform (this is never possible with forced frequency modes or any bridge on the IC market).

[0365] Before the sine wave of the piezoelectric current 353 becomes zero, the left-side high switch T1 of the H-bridge 334 is turned off (here, switch T1 is turned off when the piezoelectric current 353 is approximately 6A). The remaining piezoelectric current 353 flowing through the ultrasonic transducer 215 (the capacitor in the piezoelectric equivalent circuit), due to the energy stored in the ultrasonic transducer 215, acts as a voltage inversion during the free-float period 350. The piezoelectric current 353 decays to zero during the free-float period 350 and thereafter transitions into the negative current flow region. The terminal voltage of the ultrasonic transducer 215 drops to less than 2V from the power supply voltage (19V in this case), and the decline stops when the piezoelectric current 353 becomes zero. This is the optimal timing to turn on the low-side switch T3 of the H-bridge 334 to minimize or avoid current spikes.

[0366] Compared to the forced frequency mode described above, the native frequency mode has at least three advantages. 1. Current spikes associated with hard switching of package capacitors are significantly reduced or completely avoided. 2. There is virtually no power loss due to hard switching. 3. Frequency control is performed using a control loop, which can bring the frequency closer to the resonant frequency of the piezoelectric transducer (the natural resonant frequency of the piezoelectric transducer).

[0367] In the case of frequency adjustment by a control loop (advantage 3 above), the PMIC300 starts by controlling the bridge IC301 to drive the ultrasonic transducer 215 at a frequency above the resonant frequency of the piezoelectric transducer. The PMIC300 then controls the bridge IC301 so that the frequency of the AC drive signal is attenuated / decreased during startup. As the frequency approaches the resonant frequency of the piezoelectric transducer, the piezoelectric current develops / increases rapidly. When the piezoelectric current becomes high enough to cause the desired voltage inversion, the PMIC300 stops attenuating / decreasing the frequency. The control loop of the PMIC300 then takes over the adjustment of the frequency and duty cycle of the AC drive signal.

[0368] In forced frequency mode, the power supplied to the ultrasonic transducer 215 is controlled through the duty cycle and / or frequency shift and / or by changing the supply voltage. However, in this example, in native frequency mode, the power supplied to the ultrasonic transducer 215 is controlled only through the supply voltage.

[0369] In this example, during the setup phase of the driver device, the bridge IC 301 is configured to measure the length of time until the current flowing through the ultrasonic transducer 215 (resonant circuit) becomes zero when the first switch T1 and the second switch T2 are turned off and the third switch T3 and the fourth switch T4 are turned on. The bridge IC 301 then sets the length of the free float period to be equal to the measured length of time.

[0370] Referring here to Figure 56 of the attached drawings, the PMIC300 and bridge IC301 in this example are designed to work together as a companion chipset. The PMIC300 and bridge IC301 are electrically connected to communicate with each other. In this example, there is an interconnection between the PMIC300 and bridge IC301 that enables the following two categories of communication:

[0371] 1. Control signals 2. Feedback signal The connection between the PHASE_A and PHASE_B terminals of the PMIC300 and the bridge IC301 transmits PWM-modulated control signals that drive the H-bridge 334. The connection between the EN_BR terminal of the PMIC300 and the bridge IC301 transmits the EN_BR control signal, which triggers the activation of the H-bridge 334. The timing between the PHASE_A, PHASE_B, and EN_BR control signals is critical and is handled by the digital bridge control of the PMIC300.

[0372] The connection between the CS, OC, and OT terminals of the PMIC300 and the bridge IC301 returns the CS (current sensing), OC (overcurrent), and OT (overheating) feedback signals from the bridge IC301 to the PMIC300. Most notably, the CS (current sensing) feedback signal consists of a voltage corresponding to the rms current flowing through the ultrasonic transducer 215, which is measured by the current sensor 335 of the bridge IC301.

[0373] The OC (overcurrent) and OT (overtemperature) feedback signals are digital signals indicating that either an overcurrent or overvoltage event has been detected by the bridge IC 301. In this example, the overcurrent and overtemperature thresholds are set by external resistors. Alternatively, the thresholds can be dynamically set in response to a signal passed from one of the two DAC channels VDAC0 or VDAC1 from the PMIC 300 to the OC_REF terminal of the bridge IC 301.

[0374] In this example, the design of the PMIC300 and bridge IC301 allows the pins of these two integrated circuits to be directly connected to each other (e.g., via copper tracks on the PCB), thus minimizing delay in signal communication between the PMIC300 and bridge IC301. This provides a significant speed advantage compared to conventional bridges in the IC market, which are typically controlled by signals over digital communication buses. For example, a standard I2C bus is clocked at only 400 kHz, which is too slow to communicate sampled data at the high clock speeds of up to 5 MHz in the example of this disclosure.

[0375] While the examples of this disclosure have been described in relation to microchip hardware, it will be understood that other examples of this disclosure consist of methods for operating the components and subsystems of each microchip to perform the functions described herein. For example, a method for operating the PMIC300 and bridge IC301 in either forced frequency mode or native frequency mode.

[0376] Next, referring to Figure 57 of the attached drawing, the OTP IC 242 consists of a power-on reset circuit (POR) 354, a bandgap reference (BG) 355, a capless low-dropout regulator (LDO) 356, a communication (e.g., I2C) interface 357, a one-time programmable memory bank (eFuse) 358, an oscillator 359, and a general-purpose input / output interface 360. The OTP IC 242 also consists of a digital core 361, which includes a cryptographic authenticator. In this example, the cryptographic authenticator uses ECDSA (Elliptic Curve Digital Signature Algorithm) to encrypt / decrypt data stored in the OTP IC 242 and data transmitted to and from the OTP IC 242.

[0377] The POR354 ensures that the OTP IC242 starts up correctly only when the power supply voltage is within a predetermined range. If the power supply voltage is outside the predetermined range, the POR354 resets the OTP IC242 and waits until the power supply voltage comes within the predetermined range.

[0378] The BG355 supplies precise reference voltage and current to the LDO356 and oscillator359. The LDO356 supplies power to the digital core361, communication interface357, and eFuse memory bank358.

[0379] The OTP IC 242 is configured to operate in at least the following modes: Fuse Programming: During fuse programming (programming of one-time programmable memory), a high current is required to burn the associated fuse in eFuse memory bank 358. In this mode, a higher bias current is supplied to maintain the gain and bandwidth of the regulating loop.

[0380] Fuse Reading: In this mode, a moderate current is required to maintain fuse readings in eFuse memory bank 358. This mode is executed when the OTP IC 242 is started, transferring the fuse contents to the shadow register. In this mode, the regulation loop gain and bandwidth are set to lower values ​​than in fuse mode.

[0381] Normal operation: In this mode, the LDO356 is driven with a very low bias current, allowing the OTP IC242 to operate at low power, thus minimizing the power consumption of the OTP IC242.

[0382] Oscillator 359 supplies the necessary clock to the digital core / engine 361 during testing (SCAN Test), fixing, and normal operation. Oscillator 359 is trimmed to meet the stringent timing requirements during fixing mode.

[0383] In this example, the communication interface 357 conforms to the FM+ specification of the I2C standard, but also conforms to slow mode and fast mode. The OTP IC 242 uses the communication interface 357 to communicate with the driver device 202 (host) for data and key exchange.

[0384] The digital core 361 implements the control and communication functions of the OTP IC 242. The cryptographic authenticator of the digital core 361 enables the OTP IC 242 to self-authenticate with the driver device 202 (for example, using ECDSA encrypted messages), ensuring that the OTP IC 242 is genuine and authorized to connect with the driver device 202 (or other products).

[0385] Referring to Figure 58 in the attached drawings, the OTP IC 242 performs the following PKI procedure to authenticate the OTP IC 242 for use with the host (e.g., driver device 202): 1. Verification of the signer's public key: The host requests the manufacturer's public key and certificate. The host verifies the certificate with the certificate authority's public key. 2. Device public key verification: If verification is successful, the host will request the device public key and certificate. The host will verify the certificate using the manufacturing public key. 3. Challenge-Response: If verification is successful, the host creates a random number challenge and sends it to the device. The final product signs the random number challenge with the device's private key. 4. The signature is sent back to the host for verification using the device's public key.

[0386] If all steps of the authentication procedure are completed successfully, the chain of trust is verified down to the root of trust, and the OTP IC 242 is properly authenticated for use with the host. However, if any step of the authentication procedure fails, the OTP IC 242 is not authenticated for use with the host, and the use of devices incorporating the OTP IC 242 will be restricted or blocked.

[0387] The driver device consists of an AC driver that converts the voltage from the battery into an AC drive signal of a predetermined frequency to drive the ultrasonic transducer.

[0388] The driver device comprises an active power monitoring configuration for monitoring the active power used by the ultrasonic transducer (described above) when the ultrasonic transducer is driven by an AC drive signal. The active power monitoring configuration provides a monitoring signal indicating the active power used by the ultrasonic transducer.

[0389] The processor within the driver device controls the AC driver and receives monitoring signals from the active power monitoring configuration.

[0390] The driver device's memory stores instructions that, when executed by the processor, cause the processor to perform the following actions: A. Control the AC driver to output an AC drive signal to the ultrasonic transducer at a predetermined sweep frequency. B. Calculate the active power used by the ultrasonic transducer based on the monitoring signal. C. Control the AC driver to modulate the AC drive signal and maximize the active power used by the ultrasonic transducer. D. Record and save in memory the maximum active power used by the ultrasonic transducer and the sweep frequency of the AC drive signal. E. After a predetermined number of iterations, steps A to D are repeated a predetermined number of times, with the sweep frequency increasing or decreasing in each iteration, so that after a predetermined number of iterations, the sweep frequency increases or decreases from the sweep start frequency to the sweep end frequency. F. From the records stored in memory, identify the optimal frequency of the AC drive signal, which is the sweep frequency of the AC drive signal at which the ultrasonic transducer uses the maximum active power. G. The AC driver is controlled to output an AC drive signal to the ultrasonic transducer at the optimal frequency, driving the ultrasonic transducer to atomize the liquid.

[0391] In some examples, the active power monitoring configuration includes a current sensing configuration for sensing the drive current of the AC drive signal that drives the ultrasonic transducer, and the active power monitoring configuration provides a monitoring signal indicating the sensed drive current.

[0392] In some examples, the current sensing configuration includes an analog-to-digital converter that converts the sensed drive current into a digital signal for processing by the processor.

[0393] In some examples, memory stores instructions, when executed by the processor, to repeat steps A through D above, where the sweep frequency increases from a sweep start frequency of 2900 kHz to a sweep end frequency of 2960 kHz.

[0394] In some examples, memory stores instructions, when executed by the processor, to repeat steps A through D above, where the sweep frequency increases from a sweep start frequency of 2900 kHz to a sweep end frequency of 3100 kHz.

[0395] In some examples, memory stores an instruction that, when executed by the processor, causes the processor to control an AC driver to output an AC drive signal to an ultrasonic transducer at a frequency shifted by a predetermined amount from the optimal frequency in step G.

[0396] In some examples, the given shift amount is between 1% and 10% of the optimal frequency.

[0397] 2. Control & Information (CI) Department The control and information unit consists of an external EEPROM for data storage, an LED for user indication, a pressure sensor for airflow detection, and a Bluetooth Low Energy (BLE) compatible microcontroller for continuous monitoring and management of the aerosolization unit.

[0398] The pressure sensor used in this device serves two purposes. The first purpose is to prevent unwanted accidental starting of the sonic engine (driving the ultrasonic transducer). This function is implemented in the device's processing layout, but it is optimized for low power consumption and constantly measures environmental parameters such as temperature and ambient pressure through internal correction and baseline settings to accurately detect and classify what is called true inhalation.

[0399] Unlike all other mist inhalers on the market, this solution leverages the strengths of a microcontroller, allowing it to use only one sensor.

[0400] The second purpose of the pressure sensor is not only to accurately monitor the user's inhalation time for precise inhalation volume measurement, but also to determine the strength of the user's inhalation, which is crucial information in a healthcare setting for appropriate prescription and monitoring of health status. Overall, we can fully capture the pressure profile of every inhalation and predict the end of the inhalation for both aerosolization optimization and understanding the behavior of medical data.

[0401] This is Bluetooth TM This was made possible by using a Low Energy (BLE) microcontroller. Unlike other products on the market, it is now possible to achieve, all at once, extremely precise inhalation time, optimized aerosolization, monitoring of numerous parameters to ensure safe mist, prevention of the use of non-genuine e-liquids and aerosol chambers, and protection of both the device from overheating risks and the user from over-mist.

[0402] By using a BLE microcontroller, wireless updates become possible, allowing for the continuous delivery of improved software to users based on anonymized data collection and trained AI for PZT modeling.

[0403] 3. Power Management (PM) Department The power management section consists of an LDO (Low Dropout Regulator) that supplies power to the control and information section from a 3.7V LiPo battery, and a BMS (Battery Management System) that provides high protection and charging to the built-in LiPo battery.

[0404] Despite being such a compact, integrated device, the components in this section have been carefully and thoroughly selected to ensure high power supply to the ultrasonic irradiation unit and stable power supply to the control and information unit.

[0405] In fact, when supplying high power to the aerosolization section from a 3.7V LiPo battery, the power supply voltage fluctuates significantly during operation. Without a low-dropout regulator, when the battery voltage drops to 0.3V below the minimum rating of the components in this section, it becomes impossible to supply the necessary stable power to the control and information sections, and therefore the LDO plays a crucial role here. Losses in the CI section can cause the entire device to cease functioning.

[0406] Therefore, by carefully selecting components, it is possible not only to ensure the high reliability of the device, but also to enable operation under harsh conditions and extended charging intervals.

[0407] Controlled aerosolization Since this device is an accurate, reliable, and safe aerosolization solution for medical prescriptions and routine customer use, it must provide controlled and reliable aerosolization. This is done by an internal method that can be divided into several sections, as follows:

[0408] 1. Ultrasonic treatment To achieve optimal aerosolization, the ultrasonic transducer (PZT) needs to be vibrated in the most efficient way.

[0409] frequency Due to the electromechanical properties of piezoelectric ceramics, the components are most efficient at their resonant frequency. However, if the PZT is kept resonating for an extended period, the components will inevitably break, rendering the aerosol chamber unusable.

[0410] Furthermore, important considerations when using piezoelectric materials include variations during manufacturing and variations due to temperature and lifespan.

[0411] To resonate a PZT at 3 MHz to generate droplets smaller than 1 μm, an adaptive method is required to find and target the specific PZT "sweet spot" within all aerosol chambers used by the device with each inhalation.

[0412] sweep Because the "sweet spot" needs to be identified with each inhalation, and also due to overuse, the PZT's temperature changes using an in-house double-sweep method.

[0413] The initial sweep is performed when the instrument has not been used for a sufficient amount of time in a particular aerosol chamber for all heat dissipation to occur and the PZT to cool to its "default temperature". This procedure is also called a cold start. During this procedure, the PZT needs a boost to generate the required aerosols. This is achieved by passing through only a small subset of frequencies between 2900 kHz and 2960 kHz, which cover the resonance point, considering extensive research and experimentation.

[0414] Each frequency within this range is controlled by the sound wave engine, the current passing through the PZT is actively monitored, stored by a microcontroller via an analog-to-digital converter (ADC), and converted into a current so that the power used by the PZT can be precisely subtracted.

[0415] This provides a cold profile of the PZT in terms of frequency, and the frequency used during inhalation is the one that uses the most current, i.e., the frequency with the lowest impedance.

[0416] The second sweep is performed during subsequent inhalation, and modifications to the PZT profile regarding temperature and deformation cover the entire frequency range between 2900kHz and 3100kHz. This hot profile is used to determine the shift to apply.

[0417] shift Because aerosolization must be optimal, the shift is not used during low-temperature inhalation, and the PZT will vibrate at its resonant frequency. This can only happen if repeated in short bursts, otherwise the PZT will inevitably break.

[0418] However, the shift is used in most intakes as a way to target low impedance frequencies, achieving near-optimal operation of the PZT while protecting it from failure.

[0419] Since hot and cold profiles are saved during suction, the microcontroller can select the appropriate shift frequency according to the measured current flowing through the PZT during the sweep, ensuring safe mechanical operation.

[0420] Because piezoelectric components behave differently inside and outside the dual resonance / anti-resonance frequency range, the choice of shift direction is crucial. Since PZTs are inductive and not capacitive, the chosen shift should always be within this range defined by the resonance and anti-resonance frequencies.

[0421] Finally, the shift rate is kept below 10% so that it is close to the lowest impedance but far enough away from resonance.

[0422] adjustment Due to the inherent nature of PZT, each inhalation is different. In addition to the piezoelectric element, numerous parameters such as the amount of e-liquid remaining in the aerosol chamber, the wicking condition of the gauze, and the device's battery level all affect the inhalation results.

[0423] Therefore, the current used by the PZT in the aerosol chamber is constantly monitored, and the microcontroller continuously adjusts parameters such as frequency and duty cycle to supply the aerosol chamber with the most stable power within a predetermined range, based on research and experimental results for optimal safe aerosolization.

[0424] Battery monitoring To supply a 15V AC voltage and maintain an internal current of approximately 2.5A in the PZT, the current from the battery reaches around 7-8A, causing a drop in battery voltage. A typical LiPo battery cannot sustain this demanding resource demand for an inhalation period exceeding 6 seconds.

[0425] Therefore, we developed a custom LiPo battery capable of handling approximately 11A, which is more than 50% of the PZT's maximum allowable current, making it a compact, all-in-one portable device that is easy to use.

[0426] When the ultrasonic generator is activated, the battery voltage drops and fluctuates significantly. Therefore, the microcontroller constantly monitors the power used by the PZT in the aerosol chamber to ensure proper and safe aerosol generation.

[0427] Furthermore, since control is key to aerosolization, this device first ensures that the device's control and information unit is always functioning and does not shut down in a way that would be detrimental to the ultrasonic processing unit.

[0428] Therefore, the adjustment method takes real-time battery level into significant consideration, and if necessary, modifies parameters such as the duty cycle to maintain the battery at a safe level. If the battery level becomes low before the sonic engine starts, the control and information section will prevent it from starting.

[0429] Power control As is often said, control is key to aerosolization, and the method used in this device is a real-time multidimensional function that constantly takes into account the PZT profile, the current inside the PZT, and the device's battery level.

[0430] All of this is only achievable through the use of a microcontroller that can monitor and control every element of the device to ensure optimal suction.

[0431] 1. Inhalation control This device is confirmed to be safe in the BNS (Broughton Nicotine Services) report, but each inhalation needs to be controlled to ensure the safety of the mist and the integrity of both the aerosol chamber and the device.

[0432] Inhalation time To reduce exposure to harmful components such as carbonyls that may be generated by heating the e-liquid, the maximum inhalation time is set to 6 seconds, completely eliminating exposure to these components.

[0433] interval Because it relies on piezoelectric components, the ultrasonic irradiation unit is designed to stop operating when inhalation stops. The safety delay between two inhalations is adapted by the duration of the previous inhalation. This ensures that the gauze is properly aspirated before the next operation.

[0434] This feature allows the device to operate safely and optimize aerosolization without damaging the PZT element or exposing the user to toxic components.

[0435] Connectivity (BLE) The device's control and information unit consists of a wireless communication system using a Bluetooth Low Energy-compatible microcontroller. This wireless communication system communicates with the device's processor and is configured to send and receive data between the driver unit and computing devices such as smartphones.

[0436] Bluetooth Low Energy connectivity with companion mobile applications requires less power for this communication, allowing devices to remain functional for extended periods even when not in use, compared to traditional wireless connectivity solutions such as Wi-Fi, conventional Bluetooth, GSM, and even LTE-M and NB-IoT.

[0437] Most importantly, this connectivity enables OTP functionality and ensures complete control and safety of inhalation.

[0438] All data, from the inhalation resonant frequency to the negative pressure and duration created by the user or the device used, is stored and transmitted via BLE for further analysis and improvement of the embedded software.

[0439] Furthermore, all of this information is crucial because it allows doctors and users to access all information about the inhalation process when the device is used in a medical program, enabling real-time tracking of prescriptions and usage.

[0440] Finally, this connectivity enables embedded firmware updates both internally and over-the-air (OTA), ensuring that the latest version can always be quickly deployed. This increases the device's scalability and ensures that the device is maintainable.

[0441] Data collection for clinical purposes By collecting user data such as the number of puffs and puff duration, it is possible to determine the total amount of treatment consumed by the user in a single session.

[0442] This data can be interpreted by an algorithm that sets time-based consumption limits based on a doctor's recommendations.

[0443] This will allow for the administration of therapeutic doses of medication to users, which will be managed by doctors and pharmacists and cannot be abused by end-users.

[0444] Physicians can gradually reduce the dosage over time in a controlled manner that is safe for the user.

[0445] The limits of the puff The ultrasonic cavitation process significantly affects the nicotine concentration in the generated mist.

[0446] The device's puff time limit of 7 seconds or less restricts the user's exposure to carbonyls, which are commonly produced by electronic nicotine delivery systems.

[0447] According to experimental results from Broughton Nicotine Services, after users took 10 consecutive puffs of less than 7 seconds each, the total amount of carbonyl was less than 2.67 μg / 10 puffs for formaldehyde (average: 1.43 μg / 10 puffs), less than 0.87 μg / 10 puffs for acetaldehyde (average: 0.50 μg / 10 puffs), and less than 0.40 μg / 10 puffs for propionaldehyde (average: 0.40 μg / 10 puffs). Crotonaldehyde was detected at <0.16 μg / 10 puffs (average: 0.16 μg / 10 puffs), butyraldehyde at <0.19 μg / 10 puffs (average: 0.17 μg / 10 puffs), and diacetyl at <0.42 μg / 10 puffs (average: 0.25 μg / 10 puffs). Acetylpropionyl was not detected at all in continuous <7-second puff efflux.

[0448] Because the aerosolization of e-cigarettes is achieved by the mechanical action of a piezoelectric disc rather than by directly heating the liquid, the individual components of e-cigarettes (propylene glycol, vegetable glycerin, flavorings, etc.) remain largely unchanged and are not broken down into small harmful components such as acrolein, acetaldehyde, and formaldehyde at the high rates seen in conventional e-cigarettes.

[0449] To limit the user's exposure to carbonyl while using the ultrasound device, the puff duration is limited to a maximum of 6 seconds, so that the above result represents the absolute worst-case scenario in terms of exposure.

[0450] Referring next to Figures 59 and 60, once the end cap 248 is attached to the driver device housing 246, the aluminum driver device housing 246 acts as a Faraday cage, preventing the device from emitting any electromagnetic waves. The device with the driver device housing 246 has undergone electromagnetic compatibility (EMC) testing, and the test results have shown that the emissions are less than half of the device's acceptable limits. The EMC test results are shown in the graph in Figure 61.

[0451] Other examples of mist inhalers of the present disclosure consist of most or preferably all of the elements of the mist generator 200 described above, but the memory of the driver device 202 stores instructions that, when executed by the processor, provide additional functionality to the mist inhaler.

[0452] In one example, the mist inhaler 200 is equipped with an active power monitor that incorporates a current sensor, such as the current sensor 335 described above, for sensing the RMS drive current of the AC drive signal that drives the ultrasonic transducer 215. The active power monitor provides a monitoring signal indicating the sensed drive current, as described above.

[0453] This additional functionality allows the mist inhaler 200 to monitor the operation of the ultrasonic transducer while it is active. The mist inhaler 200 calculates an effectiveness value or quality index indicating how effectively the ultrasonic transducer is working to atomize the liquid in the device. The device uses the effectiveness value to calculate the actual amount of mist generated over the duration of the ultrasonic transducer's activation.

[0454] Once the actual amount of mist is calculated, the device is configured to calculate the actual amount of therapeutic agent present in the mist, and therefore the actual amount of therapeutic agent inhaled by the user, based on the concentration of the therapeutic agent in the liquid. Knowing the exact amount of therapeutic agent delivered to the user is particularly important when the mist inhaler is used as part of a therapeutic treatment program. Knowing the exact amount of therapeutic agent delivered to the user between each inhalation or puff allows the therapeutic treatment program to operate more accurately and effectively compared to using conventional devices that simply count the number of inhalations or puffs, assuming that each inhalation or puff delivers the same amount of therapeutic agent to the user.

[0455] In reality, as described above, there are various factors that affect the operation of the ultrasonic transducer, which in turn affect the amount of mist generated by the ultrasonic transducer and, consequently, the actual amount of therapeutic agent delivered to the user.

[0456] For example, if a low battery charge reduces the current flowing through the ultrasonic transducer, causing the ultrasonic transducer in the mist inhaler to not operate optimally, less mist will be produced and less therapeutic agent delivered to the user compared to when the device is operating optimally. Therefore, the device can allow the user to take more puffs to deliver a set amount of therapeutic agent over a period of time, compared to the number of puffs allowed when the ultrasonic transducer is operating optimally. This allows therapeutic treatment programs to operate more effectively and accurately compared to conventional programs that rely on the use of a device that simply counts and limits the number of puffs the user inhales.

[0457] Next, the configurations of several examples of mist inhalers and methods for generating mist using these mist inhalers will be described in detail below.

[0458] In this example, the mist inhaler incorporates the components of the mist inhaler 200 described above, but the memory of the driver device 202 further stores an instruction that, when executed by the processor, causes the processor to activate the mist generator 200 for a first predetermined time. As described above, the mist generator is activated by driving the ultrasonic transducer 215 within the mist generator 200 with an AC drive signal, causing the ultrasonic transducer 215 to atomize the liquid carried by the capillary element 222.

[0459] The executed instruction causes the processor to use a current sensor to periodically sense the current of the AC drive signal flowing through the ultrasonic transducer 215 for a predetermined period of time, and to store the periodically measured current value in memory.

[0460] The executed instruction causes the processor to calculate the effectiveness value using the current value stored in memory. The effectiveness value indicates the effectiveness of the ultrasonic transducer's operation when atomizing the liquid.

[0461] In one example, the executed instruction causes the processor to use this equation to calculate the effectiveness value:

[0462]

number

[0463] In one example, the memory stores an instruction, when executed by the processor, to periodically measure the duty cycle of the AC drive signal that drives the ultrasonic transducer over a first predetermined time period, and to store the periodically measured duty cycle value in memory. The mist inhaler then stores the analog-to-digital converter side effect value Q based on the current value stored in memory. AThe following correction is made. As a result, the mist inhaler in this example takes into account the duty cycle fluctuations that may occur through the activation of the ultrasonic transducer 215 when the device calculates the effect value. Therefore, the mist inhaler can accurately calculate the actual amount of mist produced by taking into account the duty cycle fluctuations of the AC drive signal that may occur while the ultrasonic transducer is operating.

[0464] In one example, the memory stores an instruction, when executed by the processor, to periodically measure the voltage of the battery supplying power to the mist generator for a predetermined period of time, and to store the periodically measured battery voltage value in the memory. The mist inhaler then uses the battery voltage value stored in the memory to determine the side effect value Q of the analog-to-digital converter. A The following correction is made. As a result, the mist inhaler in this example takes into account the battery voltage fluctuations that may occur during the operation of the ultrasonic transducer 215 when the device calculates the effective value. Therefore, the mist inhaler can accurately calculate the amount of mist actually produced, taking into account the battery voltage fluctuations that may occur while the ultrasonic transducer is operating.

[0465] The effectiveness value is used as a weight to calculate the actual amount of mist produced by the mist inhaler by proportionally reducing the maximum amount of mist that would be produced if the device were operating optimally.

[0466] In one example, the memory stores an instruction, when executed by the processor, to periodically measure the frequency of the AC drive signal that drives the ultrasonic transducer 215 over a first predetermined time period, and to store the periodically measured frequency value in the memory. The device then calculates the effect value using the frequency value stored in the memory in addition to the current value, as described above.

[0467] In one example, memory stores an instruction, when executed by the processor, that causes the processor to calculate the maximum amount of mist that would be generated if the ultrasonic transducer 215 were operating optimally for a predetermined duration. In one example, the maximum amount of mist is calculated based on a model that determines the maximum amount of mist that would be generated when the ultrasonic transducer is operating optimally.

[0468] Once the maximum mist volume value is calculated, the mist inhaler can calculate the actual mist volume value by proportionally decreasing the maximum mist volume value based on the effectiveness value to determine the actual amount of mist generated over a duration of a first predetermined length of time.

[0469] Once the actual mist volume is calculated, the mist inhaler can calculate a therapeutic dose value indicating the amount of therapeutic agent in the actual mist volume generated over a predetermined duration. The mist inhaler then stores the therapeutic dose value in memory. In this way, the mist inhaler can accurately record the actual amount of therapeutic agent supplied to the user with each inhalation or puff.

[0470] In one example, memory stores an instruction, when executed by the processor, that causes the processor to select a second predetermined time length in response to an effectiveness value. In this case, the second predetermined length is the length of time during which the ultrasonic transducer 215 is activated by the user during a second inhalation or puff. In one example, the second predetermined length is equal to the first predetermined length but is proportionally decreased or increased according to the effectiveness value. For example, if the effectiveness value indicates that the ultrasonic transducer 215 is not operating effectively, the effectiveness value causes the second predetermined length to be extended so that a desired amount of mist is generated during the second predetermined length of time.

[0471] For the next inhalation, the mist inhaler operates the mist generator for a second predetermined time so that the mist generator generates a predetermined amount of mist during that second predetermined time. In this way, the mist inhaler precisely controls the amount of mist generated during the second predetermined time, taking into account various parameters reflected by the effectiveness value that affects the operation of the mist inhaler.

[0472] In one example, memory stores instructions, when executed by the processor, to operate a mist generator for a predetermined duration. For instance, the mist generator is operated between multiple consecutive inhalations or puffs by the user.

[0473] The mist inhaler stores multiple therapeutic dose values ​​in memory, each representing an indicator of the therapeutic amount in the mist generated over one duration of a predetermined length of time. In one example, the mist inhaler prevents further activation of the mist generator for a predetermined duration if the total amount of therapeutic agent in the mist generated over a predetermined duration exceeds a predetermined threshold. In one example, the predetermined duration is in the range of 1 to 24 hours. In other examples, the predetermined duration is 24 hours or 12 hours.

[0474] Some examples of mist inhalers in this disclosure transmit data indicating therapeutic dose values ​​from the mist generator to a computing device (e.g., via Bluetooth). TM The data is transmitted (via Low Energy communication) and configured to be stored in the memory of a computing device (e.g., a smartphone). An executable application running on the computing device can record the amount of medication delivered to the user. The executable application can also control the operation of the mist inhaler to limit the amount of medication delivered to the user over a certain period of time by restricting the operation of the mist inhaler.

[0475] Therefore, some examples of mist inhalers in this disclosure are configured to prevent further activation once the user has consumed a set amount of therapeutic agent within a set time frame, such as the amount of therapeutic agent consumed in a day.

[0476] All of the above applications, including ultrasonic technology, can benefit from optimizations achieved by a frequency controller that optimizes the ultrasonic processing frequency for optimal performance.

[0477] It should be understood that the disclosures in this book are not limited to use for nicotine delivery. In fact, in some examples, mist inhalers contain liquids containing nicotine-free therapeutic agents. Some examples are configured for use for various medical purposes (e.g., delivery of CBD for pain relief, supplements for performance enhancement, albuterol / salbutamol for asthma patients, etc.).

[0478] The devices disclosed herein are intended for use with any therapeutic agent, drug, or other compound, the drug or compound being supplied in liquid form within the liquid chamber of the device for aerosolization. In some examples, the devices disclosed herein are intended for use with therapeutic agents, drugs, and compounds, including but not limited to:

[0479] respiratory system Brocodirator Olodaterol Revalterol Velodual (Ipratropium bromide / fenoterol) Combivent (Ipratropium bromide / Salbutamol)

[0480] Anti-inflammatory drugs Betamethasone Dexamethasone Methylprednisolone Hydrocortisone Mucus dissolving agent N-acetylcysteine

[0481] Pulmonary hypertension Sildenafil Tadalafil Epoprostenol Treprostenil Iroprost

[0482] infectious disease Antibiotics Aminoglycosides (gentamicin, tobramycin, amikacin, colomycin, neomycin, liposomal amikacin) Quinolone antibacterial agents (ciprofloxacin, levofloxacin, moxifloxacin, ofloxacin) Macrolide antibiotics (azithromycin) Minocycline Beta-lactam antibiotics (piperacillin, tazobactam, ceftazidime, ticarcillin, etc.) Cephalosporins (Cefotaxime, Cefepime, Ceftriaxone, Cefotaxime) Glycopeptide (vancomycin) Meropenem Polymyxin (colistin, polymyxin B)

[0483] Antifungal agents Amphotericin Fluconazole Kaspofangan

[0484] Antiviral drugs Valganciclovir Favipiravir remdesivir Acyclovir antituberculosis isoniazid Pyrazinamide Rifampin Ethambutor

[0485] Oncology Biological drugs Girotliff Afatinib Caplacizumab dupilumab Isarilumab Allylcomab Volacellid Nintedanibu Imatinib Sirolimus

[0486] chemotherapy Azacitidine Decitabine docetaxel Gemcitabine Sysplatinum

[0487] Central nervous system / mind sodium valproate Teriflunomide Zomitriptan

[0488] Metabolism and hormones Insulin estrogen

[0489] immunology vaccine Monoclonal antibodies stem cells

[0490] vitamin zinc Ascorbic acid

[0491] others Niclosamide Hydroxychloroquine Ivermectin

[0492] Some examples of ultrasonic mist inhalers 100 are more powerful than current portable medical nebulizers.

[0493] Other examples of ultrasonic mist inhalers are readily conceivable, including drug delivery devices that do not have the appearance of a cigarette.

[0494] The foregoing outlines some examples or embodiments to help those skilled in the art better understand various aspects of this disclosure. Those skilled in the art should understand that this disclosure can be readily used as a basis for designing or modifying other processes and structures to accomplish the same objectives and / or achieve the same advantages as the various examples or embodiments introduced herein. Furthermore, those skilled in the art should recognize that such equivalent structures will not deviate from the spirit and scope of this disclosure, and that various changes, substitutions, and modifications can be made to this disclosure without departing from the spirit and scope of this disclosure.

[0495] While the subject matter has been described using language specific to structural features or methodological actions, it should be understood that the subject matter of the attached claims is not necessarily limited to the specific features or actions described above. Rather, the specific features and actions described above are disclosed as exemplary forms for carrying out at least part of the claims.

[0496] This book provides various operations of examples or embodiments. The order in which some or all operations are described should not be interpreted as meaning that these operations are necessarily order-dependent. It will be understood that alternative orders may be in the interest of this book. Furthermore, it will be understood that not all operations are necessarily present in every embodiment provided here. Also, it will be understood that not all operations are necessary in some examples or embodiments.

[0497] Furthermore, "exemplary" in this document means serving as an example, instance, illustration, etc., and does not necessarily imply advantage. The use of "or" in this application is intended to mean inclusive, not exclusive. Furthermore, "a" and "an" as used in this application and the attached claims are generally interpreted as meaning "one or more" unless otherwise specified or the context makes it clear that they are singular. Moreover, to the extent that "including," "having," "having," or variations thereof are used, such terms are intended to be inclusive in the same manner as the term "including." Also, unless specifically stated, "first," "second," etc., are not intended to suggest temporal, spatial, or sequential aspects. Rather, such terms are used merely as identifiers, names, etc., for features, elements, items, etc. For example, the first element and the second element generally correspond to element A and element B, or two different elements or two identical elements or identical elements.

[0498] Furthermore, although this disclosure has been shown and described in relation to one or more embodiments, equivalent changes and modifications will be made to others skilled in the art based on a reading and understanding of this document and the accompanying drawings. This disclosure includes all such changes and modifications and is limited only to the scope of the following claims. In particular, with respect to the various functions performed by the features described above (e.g., elements, resources, etc.), the terms used to describe such features are intended to correspond to any feature that performs a predetermined function of the described feature (e.g., functionally equivalent), even if it is not structurally equivalent to the disclosed structure, unless otherwise indicated. In addition, although certain features of this disclosure may have been disclosed in relation to only one of several embodiments, such features may be combined with one or more other features of other embodiments as desired and advantageous for any given or particular use.

[0499] Examples or embodiments of the subject matter and functional operations described herein may be implemented in digital electronic circuits, computer software, firmware, or hardware, or in one or more combinations thereof, including the structures disclosed herein and their structural equivalents.

[0500] Some examples or embodiments are implemented using one or more modules of computer program instructions encoded on a computer-readable medium to control the execution or operation of a data processing device. The computer-readable medium can be a manufactured product such as a hard drive in a computer system or embedded system. The computer-readable medium can be acquired separately, such as by distribution of one or more modules of computer program instructions over a wired or wireless network, and subsequently encoded with one or more modules of computer program instructions. The computer-readable medium can be a machine-readable storage device, a machine-readable storage board, a storage device, or a combination of one or more of these.

[0501] The terms "computing device" and "data processing device" encompass all devices, equipment, and machines for processing data, including, for example, programmable processors, computers, or multiple processors or computers. In addition to hardware, a device may include code that constitutes the execution environment of the computer program, such as processor firmware, protocol stacks, database management systems, operating systems, runtime environments, or one or more combinations thereof. Furthermore, such a device may employ various different computing models, such as web services, distributed computing, and grid computing infrastructure.

[0502] The processes and logical flows described in this book can be executed by one or more programmable processors running one or more computer programs, performing functions by acting on input data and producing outputs.

[0503] Processors suitable for executing computer programs include, as an example, general-purpose and special-purpose microprocessors, and any one or more processors of any kind of digital computer. Generally, a processor will receive instructions and data from read-only memory, random-access memory, or both. Essential elements of a computer are a processor for executing instructions and one or more memory devices for storing instructions and data. Generally, a computer will include one or more mass storage devices for storing data, such as magnetic disks, magneto-optical disks, or optical disks, which are operablely coupled to receive data from or transfer data to both, or both. However, a computer is not required to have such devices. Devices suitable for storing computer program instructions and data include all forms of non-volatile memory, media, and memory devices.

[0504] In this book, "compose" means "to include, to constitute," and "comprising" means "to include, to constitute."

[0505] The features disclosed in the preceding description, the following claims, or the accompanying drawings may be expressed as appropriate in their specific forms, or in terms of means for performing the disclosed functions, or methods or processes for achieving the disclosed results, and may be used separately or in any combination of those features to realize the invention in its various forms.

[0506] Typical features Typical features are described in the following clauses, which may be used individually or in any combination with one or more features disclosed in the text and / or drawings of this document.

[0507] 1. A mist inhaler for generating a mist containing a therapeutic agent for inhalation by a user, the device comprising:

[0508] A mist generator that includes the following: A long, slender mist generator housing equipped with an air inlet port and a mist outlet port. A liquid chamber provided within a mist generator housing, containing a liquid to be atomized, wherein the liquid contains a therapeutic agent. Ultrasonic processing chamber located inside the mist generator housing A capillary element extending between a liquid chamber and an ultrasonic treatment chamber, wherein a first portion of the capillary element is located in the liquid chamber and a second portion of the capillary element is located in the ultrasonic treatment chamber. An ultrasonic transducer having an atomizing surface, wherein a portion of a second part of a capillary element overlaps a portion of the atomizing surface, and when the ultrasonic transducer is driven by an AC drive signal, the atomizing surface vibrates to atomize the liquid carried by the second part of the capillary element, generating a mist containing the atomized liquid and air inside an ultrasonic processing chamber. An airflow configuration that provides an airflow path between the air inlet port, the ultrasonic processing chamber, and the air outlet port, such that the user who inhales at the mist outlet port draws air in from the inlet port, passes through the ultrasonic processing chamber, and exits from the mist outlet port, and the mist generated in the ultrasonic processing chamber is carried by air from the mist outlet port and inhaled by the user, includes the following apparatus:

[0509] Driver device containing the following: battery An H-bridge circuit connected to an ultrasonic transducer, the H-bridge circuit is configured to generate an AC drive signal for driving the ultrasonic transducer, and the H-bridge circuit

[0510] A microchip connected to an H-bridge circuit and controlling the H-bridge circuit to generate an AC drive signal, wherein the microchip is a single unit consisting of multiple interconnected embedded components and subsystems, and includes: An oscillator configured to produce the following: Main clock signal A first phase clock signal that is high for one period of time during the positive half-cycle of the main clock signal and low during the negative half-cycle. A second phase clock signal that is high for a second time during the negative half-cycle of the main clock signal and low during the positive half-cycle of the main clock signal, wherein the phases of the first phase clock signal and the second phase clock signal are center-aligned.

[0511] A pulse-width modulation (PWM) signal generator subsystem that includes the following: The ultrasonic transducer system according to claim 1, wherein the system is configured to generate a double-frequency clock signal using the first phase clock signal and the second phase clock signal, the double-frequency clock signal having twice the frequency of the main clock signal, and the delay-locked loop is configured to control the rising edges of the first phase clock signal and the second phase clock signal to synchronize with the rising edge of the double-frequency clock signal, and the delay-locked loop is configured to generate a first phase output signal and a second phase output signal by adjusting the frequency and duty cycle of the first phase clock signal and the second phase clock signal in response to the driver control signal, and the first phase output signal and the second phase output signal are configured to generate an AC drive signal that drives an H-bridge circuit to drive an ultrasonic transducer. A first phase output signal terminal configured to output the first phase output signal to the H-bridge circuit. A second-phase output signal terminal configured to output a second-phase output signal to the aforementioned H-bridge circuit. A feedback input terminal configured to receive a feedback signal from an H-bridge circuit, wherein when the H-bridge circuit is driving an ultrasonic transducer with an AC drive signal to atomize a liquid, the feedback signal indicates the operating parameters of the H-bridge circuit or the AC drive signal.

[0512] An analog-to-digital converter (ADC) subsystem that includes: An analog converter for multiple analog signals, comprising multiple ADC input terminals configured to receive multiple analog signals, one of which is connected to a feedback input terminal so that the ADC subsystem receives a feedback signal from an H-bridge circuit, the ADC subsystem is configured to sample the analog signals received by the multiple ADC input terminals at a sampling frequency proportional to the frequency of the main clock signal, and the ADC subsystem is configured to generate an ADC digital signal using the sampled analog signals. The digital processor subsystem is configured to receive ADC digital signals from the ADC subsystem, process the ADC digital signals to generate driver control signals, and transmit the driver control signals to the PWM signal generation subsystem to control the PWM signal generation subsystem.

[0513] A digital-to-analog converter (DAC) subsystem that includes: A digital-to-analog converter (DAC) configured to convert digital control signals generated by a digital processor subsystem into analog voltage control signals, and to control a voltage regulator circuit that generates a voltage for modulation by an H-bridge circuit. A DAC output terminal configured to output an analog voltage control signal for controlling the voltage adjustment circuit to generate a predetermined voltage for modulation by the H-bridge circuit for driving the ultrasonic transducer, in response to a feedback signal indicating the operation of the ultrasonic transducer.

[0514] 2. The device described in Clause 1, wherein the microchip includes the following: A frequency divider connected to the oscillator and receiving a main clock signal from the oscillator, configured to divide the main clock signal by a predetermined divisor and output a frequency reference signal to the delay-locked loop.

[0515] 3. The apparatus described in paragraph 1 or 2, wherein the delay-locked loop consists of a plurality of delay lines connected from end to end, and the total delay time of the delay lines is equal to the period of the main clock signal.

[0516] 4. The apparatus described in paragraph 3, wherein the delay-locked loop is configured to adjust the duty cycle of the first phase clock signal and the second phase clock signal in response to the driver control signal by changing the delay of each delay line within the delay-locked loop.

[0517] 5. The apparatus according to any one of the preceding clauses, wherein the feedback input terminal is configured to receive a feedback signal from an H-bridge circuit in the form of a voltage indicating the effective current of the AC drive signal driving the resonant circuit.

[0518] 6. The apparatus according to any one of the preceding clauses, wherein the ADC subsystem comprises a plurality of further ADC input terminals configured to receive a feedback signal indicating at least one of the voltage of a battery or the voltage of a battery charger connected to the device.

[0519] 7. A device as described in any one of the preceding clauses, wherein the microchip further comprises: A temperature sensor embedded within the microchip is configured to generate a temperature signal indicating the temperature of the microchip, the temperature signal is received by a further ADC input terminal of the ADC subsystem, and the temperature signal is sampled by the ADC.

[0520] 8. The apparatus according to any one of the preceding paragraphs, wherein the ADC subsystem is configured to sample each signal sampled by the ADC subsystem along with the signals received at the plurality of ADC input terminals a predetermined number of times.

[0521] 9. A device as described in any one of the preceding clauses, wherein the microchip further comprises: A battery charging subsystem configured to control battery charging.

[0522] 10. The apparatus described in any one of the preceding clauses, wherein the DAC subsystem further comprises: A further digital-to-analog converter (DAC) configured to convert further digital control signals generated by the digital processor subsystem into further analog voltage control signals for controlling a voltage regulator circuit.

[0523] 11. An apparatus as described in any one of the preceding clauses, wherein the apparatus further comprises: A further microchip, wherein the further microchip is a single unit comprising multiple interconnected embedded components and subsystems:

[0524] First power terminal Second power terminal An H-bridge circuit incorporating a first switch, a second switch, a third switch, and a fourth switch, wherein:

[0525] The first switch and the third switch are connected in series between the first power terminal and the second power terminal. The method according to claim 1, wherein a first output terminal is electrically connected between a first switch and a third switch, and the first output terminal is connected to a first terminal of an ultrasonic transducer. A second switch and a fourth switch are connected in series between the first power terminal and the second power terminal. The ultrasonic transducer according to claim 1, wherein a second output terminal is electrically connected between the second switch and the fourth switch, and the second output terminal is connected to the second terminal of the ultrasonic transducer.

[0526] A first phase terminal configured to receive a first phase output signal from a pulse width modulation (PWM) signal generator subsystem. Second phase terminal configured to receive the second phase output signal from the PWM signal generator subsystem.

[0527] A digital state machine configured to generate a timing signal based on the first phase output signal and the second phase output signal, output the timing signal to a switch in the H-bridge circuit, and sequentially control the switch to turn on and off so that the H-bridge circuit outputs an AC drive signal for driving the ultrasonic transducer, wherein the sequence consists of a free-float period in which the first and second switches are turned off and the third and fourth switches are turned on, and the switches are turned to dissipate the energy stored by the ultrasonic transducer.

[0528] The following are the built-in sidings: A first current-sensing resistor connected in series between the first switch and the first power terminal. A first voltage sensor configured to measure the voltage drop across a first current-sensing resistor and provide a first voltage output indicating the current flowing through the first current-sensing resistor. A second current-sensing resistor connected in series between the second switch and the first power terminal. A second voltage sensor, configured to measure the voltage drop across a second current sensor resistor and to provide a second voltage output indicating the current flowing through the second current sensing resistor. Current sensor output terminal configured to output an effective voltage to ground equal to the first voltage output and the second voltage output.

[0529] The ultrasonic transducer according to claim 1, wherein the effective output voltage represents the effective current flowing through the first switch or the second switch and the current flowing through the ultrasonic transducer connected between the first output terminal and the second output terminal.

[0530] 12. The apparatus according to Clause 11, wherein the H-bridge circuit is configured to output 22W to 50W of power to the ultrasonic transducer connected between the first output terminal and the second output terminal.

[0531] 13. The device described in paragraph 11 or 12, further comprising a microchip: A temperature sensor embedded in a further microchip, wherein the temperature sensor measures the temperature of the further microchip and is configured to disable at least a portion of the further microchip if the temperature sensor detects that the further microchip is above a predetermined threshold.

[0532] 14. An apparatus as described in any one of paragraphs 11 to 13, the apparatus further comprising: A boost converter circuit configured to raise the battery voltage to a boost voltage in response to an analog voltage output signal from a DAC output terminal, comprising a boost converter circuit configured to provide the boost voltage at a first power supply terminal such that the boost voltage is modulated by switching of a switch in an H-bridge circuit.

[0533] 15. The apparatus according to any one of clauses 11 to 14, wherein the current sensor is configured to sense the current flowing through the resonant circuit during the free-float period, and the digital state machine is configured to adapt a timing signal to switch on either the first switch or the second switch when the current sensor senses that the current flowing through the resonant circuit during the free-float period is zero.

[0534] 16. The apparatus described in any one of paragraphs 11 through 15, wherein during the setup phase of the device's operation, an additional microchip is configured as follows: When the first and second switches are turned off and the third and fourth switches are turned on, measure the length of time it takes for the current flowing through the resonant circuit to become zero. The length of the free float period is set to be equal to the length of the measured time.

[0535] 17. An apparatus as described in any one of the preceding clauses, wherein the apparatus further comprises: Processor for controlling the aforementioned driver device Memory that stores instructions that, when executed by the processor, cause the driver device to perform the following actions: A. Control the driver device to output an AC drive signal to the ultrasonic transducer at a sweep frequency. B. Calculate the active power used by the ultrasonic transducer based on the feedback signal. C. Control the driver device to modulate the AC drive signal in order to maximize the active power used by the ultrasonic transducer. D. Record and save in memory the maximum active power used by the ultrasonic transducer and the sweep frequency of the AC drive signal. E. After a predetermined number of iterations, steps A to D are repeated a predetermined number of times, with the sweep frequency increasing or decreasing in each iteration, so that after a predetermined number of iterations, the sweep frequency increases or decreases from the sweep start frequency to the sweep end frequency. F. From the records stored in memory, identify the optimal frequency of the AC drive signal, which is the sweep frequency of the AC drive signal at which the ultrasonic transducer uses the maximum active power. G. The driver device is controlled to output an AC drive signal to the ultrasonic transducer at the optimal frequency, driving the ultrasonic transducer to atomize the liquid.

[0536] 18. The apparatus described in Clause 17, wherein the starting sweep frequency is 2900 kHz and the ending sweep frequency is 3100 kHz.

[0537] 19. A device as described in any one of the preceding clauses, wherein the driver device is removably mounted to the mist generator such that the driver device is separable from the mist generator.

[0538] 20. A mist inhaler for generating mist for inhalation by a user, the device comprising:

[0539] A mist generator equipped with the following: Ultrasonic processing chamber Liquid chamber containing the liquid to be atomized Capillary elements extending between the liquid chamber and the ultrasonic treatment chamber An ultrasonic transducer configured to vibrate to atomize a liquid transported from a liquid chamber to an ultrasonic processing chamber by a capillary element, thereby generating a mist consisting of the atomized liquid and air within the ultrasonic processing chamber. The mist inhaler includes a mist outlet port that is in fluid communication with the ultrasonic treatment chamber, allowing the user to inhale mist from the ultrasonic treatment chamber, and further includes the following:

[0540] Driver device containing the following: battery An AC driver that converts the voltage from the battery into an AC drive signal to vibrate the ultrasonic transducer. An active power monitor for monitoring the active power used by an ultrasonic transducer when the ultrasonic transducer is driven by an AC drive signal, wherein the active power monitor includes a current sensor for sensing the drive current of the AC drive signal that drives the ultrasonic transducer, and the active power monitor arrangement provides a monitoring signal indicating the sensed drive current. A processor for controlling the AC driver and receiving monitoring signals from the active power monitor. Memory that stores instructions that, when executed by the processor, cause the processor to do the following:

[0541] Activating a mist generator for a first predetermined time, the operation of the mist generator includes driving an ultrasonic transducer in the mist generator with an AC drive signal so that the ultrasonic transducer atomizes a liquid carried by a capillary element. A current sensor is used to periodically sense the current of the AC drive signal flowing through the ultrasonic transducer over a predetermined period of time, and the periodically measured current values ​​are stored in memory. The effectiveness value is calculated using the current value stored in memory, and the effectiveness value indicates the effectiveness of the ultrasonic transducer's operation when atomizing liquid. In response to the effectiveness value, a second predetermined time length is selected. The method according to claim 1, wherein the mist generating device is operated for a second predetermined time such that the mist generating device generates a predetermined amount of mist during the second predetermined time.

[0542] 21. The device described in paragraph 20, which stores instructions that cause the processor to perform the following actions when the memory is executed by the processor: The frequency of the AC drive signal that drives the ultrasonic transducer is measured periodically over a predetermined period of time, and the periodically measured frequency values ​​are stored in memory. The effectiveness value is calculated using the frequency value stored in the memory.

[0543] 22. The device described in paragraph 21, which stores instructions that cause the processor to use this formula to calculate an effectiveness value when executed by the processor:

[0544]

number

[0545] 23. The device described in paragraph 22, which stores instructions that cause the processor to perform the following actions when the memory is executed by the processor: The duty cycle of the AC drive signal that drives the ultrasonic transducer is measured periodically over a first predetermined period of time, and the periodically measured duty cycle values ​​are stored in memory. Based on the current value stored in the memory, the analog-to-digital converter side effect value Q A Correct it.

[0546] 24. The device described in paragraph 22 or 23, which stores instructions that cause the processor to perform the following actions when the memory is executed by the processor: The voltage of the battery supplying power to the mist generator is measured periodically over a predetermined period of time, and the periodically measured battery voltage value is stored in memory. Based on the battery voltage value stored in memory, the side effect value Q of the analog-to-digital converter is calculated. A Correct it.

[0547] 25. Any one of the devices described in the preceding clauses, wherein the memory stores instructions that, when executed by the processor, cause the processor to do the following: The maximum amount of mist that would be generated if the ultrasonic transducer were operating optimally for the first predetermined length of time is calculated. Based on the aforementioned effect value, the value of the maximum amount of mist is proportionally reduced to calculate the actual amount of mist generated during the first predetermined time period.

[0548] 26. The device described in paragraph 25, which stores instructions that cause the processor to perform the following actions when the memory is executed by the processor: The therapeutic amount value is calculated to indicate the therapeutic amount contained in the actual amount of mist generated during the first predetermined time period. The value of the treatment dose is stored in memory.

[0549] 27. The device described in paragraph 26, which stores instructions that cause the processor to perform the following actions when the memory is executed by the processor: The mist generator is operated for a predetermined duration of time. Multiple treatment dose values ​​are stored in memory, and each treatment dose value indicates the amount of treatment in the mist generated over a predetermined period of time. If the total amount of therapeutic agent in the mist generated over a predetermined period of time exceeds a predetermined threshold, further activation of the mist generator is prevented for a predetermined period of time.

[0550] 28. The apparatus described in paragraph 27, wherein the specified duration is within the range of 1 to 24 hours.

[0551] 29. The device described in paragraph 27 or 28, which stores instructions that cause the processor to perform the following actions when the memory is executed by the processor: Data indicating the therapeutic dose is transmitted from the mist generator to the computing device and stored in the computing device's memory.

[0552] 30. A method for generating a mist for inhalation by a user, comprising: Operating a mist generator for a first predetermined time, the operation of the mist generator includes driving an ultrasonic transducer in the mist generator with an AC drive signal such that the ultrasonic transducer vibrates to atomize a liquid and generate a mist containing the atomized liquid and air. The current of the AC drive signal flowing through the ultrasonic transducer is measured periodically during the first predetermined time period, and the periodically measured current value is stored in memory. The effect value is calculated using the current value stored in memory, and this effect value indicates the effectiveness of the ultrasonic transducer's operation when atomizing liquid. In response to the effectiveness value, a second predetermined time length is selected. The mist generator is operated for the second predetermined time so that it generates a predetermined amount of mist during the second predetermined time.

[0553] 31. The method described in Article 30, comprising: The frequency of the AC drive signal that drives the ultrasonic transducer is measured periodically over a predetermined period of time, and the periodically measured frequency values ​​are stored in memory. The effectiveness value is calculated using the frequency value stored in the memory.

[0554] 32. Any method described in Clause 31, which includes calculating the effectiveness value using this formula:

[0555]

number

[0556] 33. The method described in Article 32, comprising: The duty cycle of the AC drive signal that drives the ultrasonic transducer is measured periodically over a first predetermined period of time, and the periodically measured duty cycle values ​​are stored in memory. Based on the current value stored in the memory, the side effect value Q of the analog-to-digital converter ("ADC")A Correct it.

[0557] 34. The method described in paragraph 32 or 33, comprising: The voltage of the battery supplying power to the mist generator is measured periodically over a predetermined period of time, and the periodically measured battery voltage value is stored in memory. Based on the battery voltage value stored in memory, the side effect value Q of the analog-to-digital converter ("ADC") A Correct it.

[0558] 35. A method according to any one of paragraphs 30 to 34, further comprising: The maximum amount of mist that would be generated if the ultrasonic transducer were operating optimally for the first predetermined length of time is calculated. Based on the aforementioned effect value, the value of the maximum amount of mist is proportionally reduced to calculate the actual amount of mist generated during the first predetermined time period.

[0559] 36. The method described in Article 35, comprising: The therapeutic amount value is calculated to indicate the therapeutic amount contained in the actual amount of mist generated during the first predetermined time period. The value of the treatment dose is stored in memory.

[0560] 37. A method described in Article 36, comprising: The mist generator is operated for a predetermined duration of time. Multiple treatment dose values ​​are stored in memory, and each treatment dose value indicates the amount of treatment in the mist generated over a predetermined period of time. If the total amount of therapeutic agent in the mist generated over a predetermined period of time exceeds a predetermined threshold, further activation of the mist generator is prevented for a predetermined period of time.

[0561] 38. The method described in paragraph 37, wherein the specified duration is within the range of 1 to 24 hours.

[0562] 39. The method described in paragraph 37 or 38, comprising: Data indicating the therapeutic dose is transmitted from the mist generator to the computing device and stored in the computing device's memory.

Claims

1. A mist generator used in conjunction with a driver device, wherein the mist generator is A long, slender mist generating housing equipped with an air inlet port and a mist outlet port. A liquid chamber provided within the mist generating housing, a liquid chamber for containing the liquid to be atomized, An ultrasonic processing chamber provided within the mist generating housing, A capillary element extending between the liquid chamber and the ultrasonic processing chamber, wherein a first portion of the capillary element is located in the liquid chamber and a second portion of the capillary element is located in the ultrasonic processing chamber. An ultrasonic transducer having a generally planar atomizing surface provided within the ultrasonic processing chamber, wherein the ultrasonic transducer is mounted within the mist generating housing such that the plane of the atomizing surface is substantially parallel to the longitudinal axis of the mist generating housing, a portion of the second portion of the capillary element overlaps with a portion of the atomizing surface, and the ultrasonic transducer is configured to vibrate the atomizing surface to atomize the liquid carried by the second portion of the capillary element, thereby generating a mist containing the atomized liquid and air within the ultrasonic processing chamber, and An airflow arrangement that provides an air passage between the air inlet port, the ultrasonic processing chamber, and the mist outlet port, wherein the airflow arrangement is configured to allow a user who inhales from the mist outlet port to inhale air through the air inlet port, through the ultrasonic processing chamber, and through the mist outlet port, and to change the direction of the airflow when the airflow enters the ultrasonic processing chamber, and the airflow arrangement is configured A first portion begins at the air inlet port substantially parallel to the longitudinal axis of the mist generating housing and extends to a second portion of the airflow arrangement communicating with the ultrasonic processing chamber, The second portion of the airflow arrangement has a central longitudinal axis that is substantially perpendicular to the longitudinal axis of the mist generating housing and substantially perpendicular to the atomizing surface of the ultrasonic transducer, such that the direction of the airflow is substantially perpendicular to the plane of the atomizing surface of the ultrasonic transducer. A third portion of the airflow arrangement is substantially parallel to the longitudinal axis of the mist generating housing and extends from the ultrasonic processing chamber toward the air outlet opening, and the mist generated in the ultrasonic processing chamber is carried out by the air through the mist outlet port for inhalation by the user, and The mist generating housing is provided with an identification arrangement for identifying the mist generating device, and the identification arrangement is: A one-time programmable integrated circuit (OTP IC) including a memory for storing a unique identifier of the mist generator, the OTP IC comprising a digital core including a cryptographic authenticator, and The OTP IC is provided with an electrical connection that provides an electronic interface for communication between the OTP IC and the driver device, the memory of the OTP IC stores instructions to be executed by the processor to perform the following public key infrastructure (PKI) procedure to authenticate the OTP IC when coupled to the driver device, and the OTP IC is programmed to do the following: (1) In response to a request from the driver device, the OTP IC transmits the manufacturing public key and the manufacturing certificate to the driver device, and the driver device verifies the manufacturing certificate using the certification authority public key. (2) If the verification is successful, the OTP IC transmits the device public key and device certificate to the driver device in response to a request from the driver device, and the driver device verifies the device certificate using the manufacturing public key. (3) Challenge-Response: If the verification is successful, the OTP IC receives a random number challenge from the driver device, the cryptographic authenticator of the OTP IC signs the random number challenge with the device secret key, and (4) The OTP IC transmits a signature to the driver device for verification using the device public key. If all steps (1) through (4) of the above procedure are completed successfully, the OTP IC will be authenticated for use with the driver device. If any of steps (1) through (4) of the above procedure fails, the OTP IC will not be certified for use with the driver device, and the use of the mist generator incorporating the OTP IC will be restricted or blocked. Mist generator.

2. The mist generator according to claim 1, wherein the OTP IC includes an anti-counterfeiting integrated circuit (IC) programmed to identify a genuine mist generator and to allow only the mist generator identified as genuine to be used with the driver device.

3. The mist generator according to claim 1, wherein the OTP IC controls the mist generator to generate mist only when permitted.

4. The mist generator according to claim 1, characterized in that when the mist generator is connected to the driver device, the OTP IC is electrically connected to the power management integrated circuit (PMIC) of the driver device, receives power from the PMIC so as to manage the voltage supplied to the OTP IC, and the OTP IC is connected to the communication bus of the driver device.

5. The mist generator according to claim 1, wherein the OTP IC stores unique information data that enables the traceability of the mist generator and monitoring of the amount consumed by the user of the mist generator.

6. The mist generator according to claim 1, wherein the OTP IC is read by the driver device which recognizes the mist generator and the user associated with the mist generator.

7. The mist generator according to claim 1, wherein the driver device cannot be used multiple times together with the mist generator, and cannot be used outside the period specified by the prescription for use of the mist generator.

8. The mist generator according to claim 1, wherein the memory of the OTP IC stores a record of the state of the mist generator, which indicates at least one of the usage history of the mist generator and the volume of liquid in the liquid chamber.

9. The mist generator according to claim 1, characterized in that the memory of the OTP IC stores a record of the time in seconds for aerosolization, such that the mist generator is deemed to have no liquid in the liquid chamber after a predetermined usage time of approximately 1000 seconds for aerosolization, and is unable to start up after the predetermined usage time.

10. The mist generator according to claim 1, characterized in that whenever the mist generator is deemed to be empty, the mist generator does not operate if it is connected to the driver device.

11. The mist generator according to claim 1, further combined with a mobile companion digital app which is a link between a user account on the manufacturer's digital platform and the mist generator.

12. The mist generator according to claim 11, wherein the mobile companion digital app ensures that a safe amount of liquid is used for a safe amount of time.

13. The mist generator according to claim 1, characterized in that the cryptographic authenticator uses an elliptic curve digital signature algorithm (ECDSA) for at least one of the encryption and decryption of data stored in the OTP IC and data transmitted and received to and from the OTP IC.

14. The mist generator according to claim 1, wherein the cryptographic authenticator of the digital core enables the OTP IC to authenticate itself using at least one ECDSA encrypted message with the driver device to ensure that the OTP IC is genuine and that the OTP IC is authorized to connect to the driver device.

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