Systems and methods for delivering aerosols in a compact mobile configuration

Abstract

The present disclosure provides aerosol delivery systems, including systems implemented in a compact mobile configuration. Embodiments disclosed herein also generally relate to software and methods for aerosol delivery, including dynamically adjustable aerosol delivery, and further including broad spectrum delivery, e.g., of therapeutic formulations of drugs, drug mixtures, emulsions, and combinations thereof, that can be implemented over a range of adjustable and variable concentrations, relying on precise real-time control of variables monitoring.

Description

Technical Field

[0001] The embodiments disclosed herein generally relate to aerosol delivery systems, including systems implemented in a compact, mobile configuration. The embodiments disclosed herein also generally relate to software and methods for aerosol delivery, including dynamically adjustable aerosol delivery and broad-spectrum delivery relying on precise real-time monitoring of control variables. Background Technology

[0002] Currently, existing drug delivery devices are limited in their ability to deliver a wide range of drugs, drug mixtures, emulsions, and combinations thereof in a non-destructive (non-thermal) manner within a compact, mobile form factor and at adjustable and variable concentration ranges. Nebulizers that non-destructively generate drug solution aerosols using vibrating meshes, ultrasonic transducers, or jets, with particle size distributions optimized for effective pulmonary absorption, are currently limited in their ability to achieve this under varying drug compositions, viscosity ranges, and environmental conditions. Furthermore, different patient populations have different dosage requirements and inhalation behaviors, further complicating the achievement of optimized aerosol delivery and thus limiting the applicability of nebulization technology to the vast majority of available drugs and indications, making it effective only for a small subset.

[0003] This necessitates a specific control system and software framework housed within a compact mobile form factor to generate a wide range of aerosols with target particle size distributions tailored to patient behavior and treatment requirements. However, for such a control system to be deployed within a mobile device, it must be able to utilize / access specific aerosol mixing geometries and manifold volumes to enable broader pulmonary delivery of therapeutic drugs and their mixtures. Specifically, various drug aerosols exist that require minimum bolus volumes per respiratory volume and not only specific aerosol particle size distributions but also specific aerosol droplet concentrations in the air-diluent excipient fluid. Generating these specific volumes, droplet concentrations, and particle size distributions for optimized pulmonary delivery requires minimal mixing volumes and enabling flow channel geometries. Currently, no bolus aerosol delivery capability has been developed or deployed. Such manifold designs require satisfactory mixing volume and geometry for air mixing and can be integrated into a mobile form factor. Integrating this manifold design into a mobile form factor is a major limitation of existing technologies because existing devices require a larger size to achieve the same effect. Current device designs limit suppliers' ability to practically deploy such devices in environments outside of hospitals or homes.

[0004] Beyond the physical volume and geometric requirements of the nebulizer manifold mixing, achieving dynamic actuation control of the nebulizer necessitates real-time and accurate monitoring of environmental conditions, patient inhalation behavior, and the aerosol particle size distribution and concentration within the manifold mixing chamber. This real-time, precise monitoring of these "control variables" forms the basis of the intelligent control system's inputs. Combined with a pre-coded model, these inputs allow for dynamic fine-tuning of particle size distribution, aerosol actuation rate, particle concentration, drug concentration per particle, and injection volume via the control system, applicable to a wide range of patient populations and conditions. Accurate real-time monitoring of these control variables requires measuring real-time dynamic events and aerosol characteristics using specific hardware sensing elements. These events and characteristics can be converted into control variables to adjust and tune aerosol characteristics to a set of target optimal values ​​within a closed loop. The key to achieving this functionality lies in real-time measurement of aerosol characteristics and how the coded model-based control system framework dynamically adjusts these characteristics as the actuation waveform of the drug actuator / nebulizer element is adjusted.

[0005] Therefore, there is a need for a system that is compact, mobile, dynamically tunable, and controllable / monitorable in real time for aerosol delivery. Attached Figure Description

[0006] Figure 1 This is a schematic diagram of a computer-implemented system according to various embodiments of the present disclosure.

[0007] Figure 2 This is a schematic diagram of a computer-implemented system for delivering and monitoring treatment protocols and its associated software modules according to various embodiments of the present disclosure.

[0008] Figure 3 This is a schematic diagram of the hardware device of a computer-implemented system for delivering and monitoring treatment protocols according to various embodiments of the present disclosure.

[0009] Figure 4 This is a perspective view of a hardware device (e.g., a nebulizer) according to various embodiments of the present disclosure, which is configured to work in conjunction with a computer-implemented system for delivering and monitoring treatment protocols.

[0010] Figure 5 For the various embodiments according to this disclosure Figure 4 An exploded perspective view of the hardware device (e.g., an atomizer).

[0011] Figure 6 According to the various embodiments of this disclosure Figure 4 An exploded perspective view of opposite sides of a hardware device (e.g., an atomizer).

[0012] Figure 7AThe image shows a perspective cross-sectional view of a hardware device (e.g., a nebulizer) according to various embodiments of the present disclosure, the hardware device being configured to work in conjunction with a computer-implemented system for delivering and monitoring treatment protocols.

[0013] Figure 7B According to the various embodiments of this disclosure Figure 7A Bottom perspective view of the hardware device (e.g., atomizer).

[0014] Figure 8 This is a perspective view of a manifold configured for incorporation into a hardware device (e.g., a nebulizer) according to various embodiments of the present disclosure, the hardware device being configured to cooperate with a computer-implemented system for delivering and monitoring treatment protocols.

[0015] Figure 9 This is a perspective view of a cartridge configured for use with a hardware device (e.g., a nebulizer) according to various embodiments of the present disclosure, the hardware device being configured for use with a computer-implemented system for delivering and monitoring treatment protocols.

[0016] Figure 10 According to the various embodiments of this disclosure Figure 7A A transparent perspective view of the medicine cartridge.

[0017] Figure 11 This is a perspective view of a cartridge configured for use with a hardware device (e.g., a nebulizer) according to various embodiments of the present disclosure, the hardware device being configured for use with a computer-implemented system for delivering and monitoring treatment protocols.

[0018] Figure 12 According to the various embodiments of this disclosure Figure 7A A perspective cross-sectional view of a hardware device (e.g., an atomizer) including a manifold and cartridge.

[0019] Figure 13 The following are perspective views, cross-sectional views, and fluid diagrams of hardware devices (e.g., nebulizers) according to various embodiments of the present disclosure, the hardware devices having scalability and being configured to work in conjunction with computer-implemented systems for delivering and monitoring treatment protocols.

[0020] Figure 14 This is a perspective view of a hardware device (e.g., a nebulizer) according to various embodiments of the present disclosure, which is configured to work in conjunction with a computer-implemented system for delivering and monitoring treatment protocols.

[0021] Figure 15This is a perspective view of a hardware device (e.g., a nebulizer) according to various embodiments of the present disclosure, the hardware device having scalability and being configured to work in conjunction with a computer-implemented system for delivering and monitoring treatment protocols.

[0022] Figure 16 The image shows a perspective cross-sectional view of a hardware device (e.g., a nebulizer) according to various embodiments of the present disclosure, the hardware device having scalability and being configured to work in conjunction with a computer-implemented system for delivering and monitoring treatment protocols. Detailed Implementation

[0023] This specification and appendices describe various exemplary aerosol delivery systems, including systems implemented in a compact mobile configuration; software and methods for aerosol delivery, including dynamically adjustable aerosol delivery; and software and methods for achieving broad-spectrum delivery based on precise real-time monitoring of control variables. However, this disclosure is not limited to these exemplary embodiments and applications, nor is it limited to the manner in which the exemplary embodiments and applications are operated or described herein.

[0024] Unless otherwise defined, the scientific and technical terms used herein in connection with this disclosure shall have the meanings commonly understood by one of ordinary skill in the art. Furthermore, unless the context otherwise requires, singular terms shall include plural concepts, and plural terms shall include singular concepts.

[0025] For further details, please see the appendix. Aerosol delivery systems are also discussed in PCT / US2022 / 022378, the entire contents of which are incorporated herein by reference.

[0026] While nebulization for cardiopulmonary drug delivery offers significant therapeutic advantages, it is constrained by key limitations of existing technologies. Traditional vaporization methods suffer from drug thermal degradation, which can affect efficacy and potentially generate harmful byproducts. Although nebulization is a preferred alternative, its high sensitivity to drug viscosity limits the range of compatible drug formulations and poses a significant challenge to achieving accurate dosing titration. Furthermore, substantial condensate loss during aerosol delivery, coupled with the lack of precise real-time particle size and mass flow measurements, hinders reliable delivery of specific doses, particularly for drugs requiring stringent dosing control. This limitation prevents the effective nebulization of many drugs that would otherwise benefit cardiopulmonary administration. Alternative delivery methods, such as dry powder inhalers (DPIs) and propellant-based metered inhalers, address some of these limitations by pre-dosing and mitigating viscosity issues. However, even these methods lack the broad applicability required to fully realize the potential of cardiopulmonary drug delivery. Therefore, there is an urgent need for a nebulization system that overcomes these limitations, enabling accurate, efficient, and reliable delivery of a wider range of drugs, including those requiring precise dosing control and high specific doses. This disclosure addresses this need by providing a novel hardware device (e.g., a nebulizer) that integrates advanced Venturi hydrodynamics to minimize condensate loss, a dynamic light-scattering turbidimeter for real-time particle size and mass flow measurements, and a processing unit that dynamically adjusts the PWM signal delivered to the drug actuator or nebulizing element (e.g., a nebulizer mesh element) for precise dose titration and particle size control. By mitigating the challenges associated with condensate loss and inaccurate dose measurement, this invention extends the applicability of nebulized drug delivery to a wider range of medications, including those sensitive to dose variations. This advancement enables the safe and efficient delivery of medications previously unsuitable for nebulization, thereby improving patient outcomes and broadening the therapeutic scope of cardiopulmonary drug delivery.

[0027] the term Please note that the discussion in this section refers to any and all information provided in this application, whether it is located in the specification, appendices, drawings, or applications incorporated by reference. The discussion herein is not intended to limit the use or meaning of these terms in any way, but merely to provide further detail to aid understanding.

[0028] The atomizing chamber can also be referred to as, for example, a telescopic inhalation funnel, an inhalation funnel, a telescopic aerosol mixing chamber, and / or an internal droplet delivery zone.

[0029] Vapors, droplets, or atomized aerosols should be understood to include any air (or gas) diluting fluidized particles containing a drug, a combination of drugs, a formulation component, an admixture, or a combination thereof.

[0030] A drug actuator can refer to a mesh atomizing element. It can also refer to any type of atomizing element hardware capable of generating suspended particulate aerosols in a non-thermal (non-destructive) manner. Such methods can include, for example, jetting, ultrasonic, mesh, etc.

[0031] The mixing chamber and / or manifold may be referred to as a fluid mixing block. The fluid mixing block may employ a manifold design that allows two components to be mixed at the source end along a flow path into a chamber directly connected to the mesh atomizing element (as an example of one of many drug actuator implementations), thereby enabling the drug to be actuated into a fluidized aerosol. Additional optional components that can facilitate precise treatment protocols, based on accurate injection generation and real-time delivery, include, for example: (1) a low-flow-capacity manifold design; (2) a small-volume mesh element supply container (which can directly contact the atomizing element); and (3) a dynamically adjustable drug component flow valve that allows fine-tuning of dynamic viscosity and component mixing ratios (e.g., drug concentration). Since the adjustment of key aerosol particle properties may also include fine-tuning of drug supply mixing, which takes effect with a delay until the existing material volume within the manifold is depleted, small-volume manifolds and supply containers help to reduce adjustment lag times during dynamic operation.

[0032] The cartridge module can also be called a pharmaceutical container. Pharmaceutical containers can be configured to maintain a constant back pressure while maintaining a compact size and low manufacturing cost. Using a spring or similar mechanism as a near-constant back pressure energy source reduces the complexity and power requirements of the flow control valve, thereby enabling fine-tuning of the component mixing ratio.

[0033] A specific vapor density flow rate analyzer (also known as a specific vapor density flow rate control module) provides a means of measuring and automatically analyzing the dynamic characteristics of vapor generated (at the source) and exiting (at the sink) the "inhalation funnel" / "nebulizer chamber" (see the preceding discussion of the nebulizer chamber). This hardware component and workflow can assist mobile nebulizer devices in accurately delivering and measuring the target drug injection within a series of treatment regimens. This can be achieved via photon-based transmission, emission, and / or scattering readouts, which are associated with a basic set of coded models and coded setpoints that the system can use to estimate the specific vapor density flow rate, particle size distribution, drug concentration per particle, the difference between the vapor generation rate and the vapor output rate (vapor yield), and droplet decay rate. In some cases, this method may resemble the operation of a dynamic light scattering system or a turbidimeter, but is optimized for accurate measurement of the fluidized particle flow within the inhalation funnel volume and transport path. Larger sample volumes (effective sample volume), longer particle flow paths, and larger funnel volumes can improve the accuracy of readout measurements. When dynamically measuring vapor characteristics during a treatment regimen, the software can translate a modified set of control instructions into control instructions that adjust the drug cartridge flow rate, drug concentrate-diluent mixing ratio, and / or drug actuator (mesh element) signal waveforms via a base set model, control values, and setpoints to achieve a target specific vapor density with a corresponding flow rate. In this example, it is possible to implement and verify target drug bolus, pulmonary delivery efficiency, and overall treatment regimen accuracy in a mobile device—something that was never possible before. Therefore, a specific vapor density flow analyzer may include, for example, at least one sensor operatively communicating with a logic module and configured to detect at least one characteristic associated with the user dispensing medication from the nebulizer.

[0034] discuss Current solutions for providing compact mobile form factors for aerosol delivery suffer from various problems. One limitation is the limited range of drugs that can be applied to nebulizers with compact mobile form factors, for reasons such as: (1) Mixing limitations of “droplet aerosol” and “air mixing volume”. The minimum internal mixing volume required to achieve adequate mixing of droplet aerosol with air diluent within a compact mobile form factor makes it impossible to deploy multiple available drugs outside of hospital or home environments.

[0035] (2) Limitations of the nebulizer element’s ability to generate high-concentration, stable aerosols with optimized pulmonary absorption properties, where stability may refer to the droplet half-life during delivery and / or the emulsion stability within the aerosolized droplets (in cases where the droplets can contain an emulsified oil-soluble drug mixture). Preferably, the aerosol particle size distribution and droplet drug concentration can be dynamically fine-tuned to optimally follow specific vapor density targets and corresponding drug bolus mass flow rate targets, depending on, for example, measured control variables, patient behavior, droplet delivery stability half-life, and coded models. Because the drug concentration mixture of the incoming fluid is also dynamically adjusted, the drug actuator (e.g., the nebulizer element) should also optimize its signal waveform driver to match the variable viscosity characteristics of the incoming drug mixture.

[0036] (3) Limitations of existing compact mobile hardware in storing one or more drug solutions or concentrates and diluents. To enable the application of a wide range of different drugs in portable aerosol form, a method for storing and quantitatively dispensing drug sources and diluent input fluids is needed.

[0037] (4) Due to the current lack of hardware capable of dynamically changing the drug and diluent input actuation feed ratio, there are limitations in generating specific aerosol densities, particle size distributions, droplet drug concentrations, drug mass flow rates corresponding to each inhalation bolus, and overall lung delivery efficiency. To maintain a consistent drug concentration in each aerosol droplet, the drive waveform of the drug actuator or nebulizer element needs to be dynamically adjusted according to different drug-to-diluent mixing ratios to adapt to the viscosity of the input fluid.

[0038] (5) There are limitations to the ability to dynamically fine-tune aerosol droplet size and density based on measured control variables, thereby achieving and maintaining specific aerosol density targets, total bolus volume per breath, and overall net cumulative dose per drug delivery cycle.

[0039] (6) Drug actuators (e.g., atomizing elements) have limitations in their ability to nondestructively atomize drugs, complex drug mixtures, adducts and functional molecular motifs / structures by controlling shear forces, droplet size, drug and diluent mixing balance and other physical constants (e.g., temperature, pressure) associated with droplet formation.

[0040] This disclosure discusses various features that can be used alone or in combination to address these limitations.

[0041] (A) Telescopic Atomizing Chamber. The telescopic vapor mixing manifold provides a pathway sufficient to achieve both droplet aerosol and air mixing volume. This manifold enables precise optical measurements of specific vapor density concentrations (number of droplets per unit volume), particle size distribution, aerosol flow rate, drug concentration, and droplet stability half-life. Optimized flow field geometry and air diluent injection enable Venturi-enhanced droplet aerosol mixing within a compact flow channel and volume.

[0042] (B) Dynamic atomizer actuator signal waveform fine-tuning control algorithm and variable input model.

[0043] (C) A multi-chamber pharmaceutical storage tank with level and flow sensing functions. The multi-chamber storage tank may incorporate one or more optical, inductive, capacitive, Hall effect, mechanical, or magnetic level detection methods. The chamber output flow rate of the storage tank can be measured using mechanical (typically MEMS), thermal, Hall effect, optical, ultrasonic, or inductive methods. The sensor output model can be fine-tuned using flow-geometric parameters.

[0044] (D) Fluid Mixing Block. The mixing block includes a compact multi-compartment output mixing manifold with variable compartment output volumetric flow rate mixing control. It may also include a dynamic control variable mixing ratio fine-tuning algorithm that adjusts the drug concentration mixture composition based on, for example, the output of a specific vapor density flow analyzer / sensor, thereby achieving a target drug concentration within each droplet at a specific droplet aerosol concentration and a corresponding mass flow rate per breath.

[0045] (E) Specific vapor density flow analyzer / sensor. This may include, for example, optical measurements of specific vapor density concentration (number of droplets per unit volume), particle size distribution, aerosol flow rate, drug concentration, and / or droplet stability half-life using methods such as photon transmission, dynamic photon scattering, and / or photon absorbance. This feature also enables Venturi-enhanced optical readout for detecting droplet size distribution, concentration, decay rate (e.g., droplet condensate loss rate typically caused by droplet maturation), and velocity, due to the larger vertical component of the flow streamlines within the manifold relative to the optical sensing element.

[0046] Now for reference Figures 2-12This disclosure provides a hardware device (e.g., a portable nebulizer) 16. The portable nebulizer 16 includes a housing 169 defining a storage / mixing chamber 1691 and an atomizing chamber 1692. A power source (e.g., a battery) may be disposed between or parallel to the storage / mixing chamber 1691 and the atomizing chamber 1692 (e.g., in a row). The storage / mixing chamber 1691 houses a cartridge 163 and a storage portion (e.g., a cavity) 1810 of a manifold 180. An outlet 170 is disposed in the housing 169, in fluid communication with the atomizing chamber 1692, and generally opposite the storage / mixing chamber 1691.

[0047] In various embodiments, a portion of the atomizing chamber 1692 serves as an integrated storage / mixing chamber 1691 and is configured to mix (e.g., dilute) the concentrated vapor generated at the drug actuator 1832 with air or another diluent, causing the diluted vapor to exit from the outlet 170. In various embodiments, a single chamber in the device 16 can simultaneously serve as both the atomizing chamber 1692 and the storage / mixing chamber 1691. In various embodiments, a single chamber in the device 16 can simultaneously serve as both the atomizing chamber 1692 and the storage / mixing chamber 1691, such that the functions of both the atomizing chamber and the storage / mixing chamber are achieved by the same chamber.

[0048] The cartridge 163 may include one or more medicine containers (illustrated by features 1631a-c). The at least one container (e.g., 1631a, b, and / or c) contains a medicine. In various embodiments, the cartridge 163 includes more than one medicine container, each configured to store a medicine. If the medicine is concentrated, at least one other container 1631b-c may include a medicine carrier for diluting the concentrated medicine before administration to a user. In various embodiments, the cartridge 163 is replaceable. In various embodiments, the cartridge 163 is not easily removed from the housing 169.

[0049] The atomizing chamber 1692 may be in fluid communication with at least one drug container (e.g., 1631a-c) and may include a manifold 1830 with an embedded drug actuator (e.g., an embedded atomizing mesh), the manifold being configured to mix a portion of the drug with a drug carrier and / or other drugs or diluents before reaching the drug actuator 1832 in the surface of the embedded (e.g., embedded atomizing mesh) manifold 1830. The drug actuator(s) 1832 of the atomizing chamber 1692 may also include one or more atomizing mesh elements (e.g., one or more piezoelectric elements) or in the form thereof, electrically connected to a power source 162 via electrical contacts (not shown for clarity), and may be configured to evaporate (e.g., atomize) the drug to form drug vapor flowing out from the top 1835 of the manifold 180. In various embodiments, one or more drug actuators 1832 (e.g., nebulizer mesh elements or evaporator heating / ultrasonic elements) are orthogonal or substantially orthogonal to the direction of travel 1840 of one or more drugs from the storage chamber 1810 to the drug actuator 1832 and then to the outlet port 1835 of the manifold 180 (e.g., such that the face of the actuator is antiparallel, orthogonal or substantially orthogonal to the direction of travel 1840).

[0050] The logic / computation module 166 within the atomizer 16 is configured to enable the atomizer 16 to receive data from and send data to the remote software environment 12. The remote software environment 12 may include instructions that, when queried by the logic / computation module 166, restrict the use of the atomizer if one or more usage conditions are not met (e.g., preventing power to the drug actuator(s) 1832, such as the atomizer mesh or vaporizer heating element / ultrasonic plate).

[0051] In various embodiments, the atomizer 16 further includes a hardware network module 161 that is operatively communicative with the logic / computing module 166 and configured to enable bidirectional data communication between the atomizer 16 and the remote software module 12.

[0052] In various embodiments, the atomizer 16 also includes a hardware security module 164 that is operatively communicateable with the logic / computing module 166 and configured to prevent unauthorized dispensing of medication from the atomizer 16.

[0053] In various embodiments, the nebulizer 16 further includes at least one sensor 168 operatively communicating with the logic / computing module 166 and configured to detect at least one characteristic associated with the user dispensing medication from the nebulizer 16. In various embodiments, the sensor 168 is one or more of the following: a sensor (e.g., a laser particle sensor or an ionization sensor) for assessing the density of vapor flowing from the medication actuator (e.g., an atomizing mesh) 1832; a flow sensor (e.g., a pressure sensor or a volumetric flow sensor) for assessing the amount of vapor inhaled by the user through the outlet; a flow sensor (e.g., a fluid flow sensor) for assessing the amount of medication drawn from the cartridge; a position sensor for assessing changes in the position of a float or plunger associated with the volume of medication; and a pH sensor for assessing the pH level of vapor flowing from the medication actuator (e.g., an atomizing mesh).

[0054] In various embodiments, the logic / computing module 166 is configured to control the power supplied from the power source to the dosing actuator (e.g., atomizing mesh) or evaporator heating element / ultrasonic plate 1820 in response to calibration data received from the remote software environment 12.

[0055] In various embodiments, the logic / computing module 166 is configured to control the power supplied from the power source to the drug actuator (e.g., atomizing mesh) or evaporator heating element / ultrasonic plate 1820 in response to calibration data received from the remote software environment 12 and information obtained from one or more sensors 168.

[0056] In various embodiments, the logic / computing module 166 is configured to, in response to security information received from the remote software environment 12, cause the hardware security module 164 to prevent power from flowing from the power source to the drug actuator (e.g., atomizing mesh) or the vaporizer ultrasonic plate 1820. In various embodiments, the security information includes information associated with the authorized drug dispensing frequency.

[0057] In various embodiments, the logic / computing module 166 is configured to receive information acquired from at least one sensor 168. In various embodiments, the logic / computing module 166 is also configured to transmit the information acquired from the at least one sensor 168 to a remote software environment 12.

[0058] Now for reference Figure 13 The figures illustrate a perspective view (A), a perspective sectional view (B), and a fluid schematic diagram (C) of a hardware device (e.g., a nebulizer) according to various embodiments of the present disclosure, the hardware device having scalability and being configured to cooperate with a computer-implemented system for delivering and monitoring treatment protocols. In an extended (e.g., scalable) configuration, such as... Figure 13As shown in the figure, the hardware device 16 (e.g., an atomizer) is configured to extend (around the static portion or housing 1340) to provide a larger internal volume inside the housing 169, such that an air inlet 1639 located at a specific optimized position along the sidewall of the housing 169 allows microdroplet aerosol diluent (e.g., air) to flow into the storage / mixing chamber 1691 in a laminar flow 1322 with a vector direction substantially perpendicular to the net flow direction of the vapor flow. This maintains a laminar separation gap between the microdroplet-containing aerosol and the inner sidewall of the housing 169, which helps reduce condensate loss of the agent along the flow path and further confines the aerosol to the center of the flow path away from the sidewall by enhancing the central column aerosol vortex within the Venturi region, thereby further reducing condensate loss.

[0059] In various embodiments, the housing portion serves to protect certain components from damage when not in use and can be retracted from its initial position to allow access to specific interface components or features (e.g., buttons, mouthpiece openings (170), etc.). In various embodiments, the housing portion can be retracted from its initial position to reduce the internal flow path and internal volume of the housing 169 according to the specific characteristics of the aerosol (e.g., size distribution, concentration, decay rate, etc.).

[0060] Regarding the air inlet 1639, in various embodiments, the air inlet gap 1639 may be disposed between the housing 1630 of the cartridge module 163 and the housing 169 of the hardware device 16. If the air inlet gap 1639 is present, air is drawn into the interior of the hardware device 16 through this gap (e.g., into the storage / mixing chamber 1691). In various embodiments, the aperture of the air inlet gap 1639 is approximately 50 μm to approximately 500 μm, approximately 100 μm to approximately 400 μm, or approximately 200 μm to approximately 300 μm, for example, approximately 50 μm, approximately 60 μm, approximately 70 μm, approximately 80 μm, approximately 90 μm, approximately 100 μm, approximately 110 μm, approximately 120 μm, approximately 130 μm, approximately 140 μm, approximately 150 μm, approximately 160 μm, approximately 170 μm, approximately 180 μm, approximately 190 μm, approximately 200 μm, approximately 210 μm, approximately 220 μm, approximately 230 μm. μm, approximately 240 μm, approximately 250 μm, approximately 260 μm, approximately 270 μm, approximately 280 μm, approximately 290 μm, approximately 300 μm, approximately 310 μm, approximately 320 μm, approximately 330 μm, approximately 340 μm, approximately 350 μm, approximately 360 μm, approximately 370 μm, approximately 380 μm, approximately 390 μm, approximately 400 μm, approximately 410 μm, approximately 420 μm, approximately 430 μm, approximately 440 μm, approximately 450 μm, approximately 460 μm, approximately 470 μm, approximately 480 μm, approximately 490 μm, or approximately 500 μm. In various embodiments, the air inlet gap 1639 is provided on the sidewall of the housing 169 (e.g., see...). Figure 13 and Figure 15 In various embodiments, the air inlet gap 1639 is located on the bottom surface of the housing 169 (for example, see...). Figures 7A-7B , Figure 12 ).

[0061] Figure 13Cross-sectional view (B) shows hardware device 16, which includes control surfaces 1636 (e.g., fins), flow guides 1320, and turbulent Venturi mixing (within the turbulent Venturi mixing zone 1637) along an extended flow path volume formed by the expansion and contraction characteristics of device 16. Specifically, the flow guides 1320, initiated by control surfaces 1636, impart a tangential velocity component to the incoming aerosol flow, thereby generating a circular vortex guide for the aerosol flow. This annular guide occurs in the lower laminar region, where the flow is initially ordered and predictable. As the aerosol flow advances upward within the extended flow path volume, it enters a turbulent transition zone. In this region, the kinetic energy of the rotating flow is converted into turbulent kinetic energy. Finally, the flow transitions to the upper turbulent Venturi mixing zone 1637, where the vortices formed evolve into a Venturi effect. This Venturi effect is enhanced by a net pressure drop along the extended flow path volume (from the inlet to the user's suction point), which sustains and reinforces the vortices. Therefore, the flow guide 1320 at the bottom of the cavity induces annular guidance, which, combined with the macroscopic pressure drop generated along the entire length of the extended flow path volume, can form and enhance Venturi mixing at the top. Also refer to the fluid schematic diagram (C) for separate illustration of the flow guide, laminar region, turbulent transition region, and turbulent Venturi mixing region.

[0062] Now for reference Figure 14 The illustration shows a perspective view of a hardware device 16 (e.g., a nebulizer) according to various embodiments of the present disclosure, configured to cooperate with a computer-implemented system for delivering and monitoring treatment protocols. As described above, in various embodiments, the nebulizer 16 may include at least one sensor 168 operatively communicating with a logic / computing module 166 and configured to detect at least one characteristic associated with medication dispensed by a user from the nebulizer 16. In various embodiments, the sensor 168 is one or more of the following: a sensor (e.g., a laser particle sensor or an ionization sensor) for assessing the density of vapor flowing from a medication actuator (e.g., an atomizing mesh) 1832; a flow sensor (e.g., a pressure sensor or a volumetric flow sensor) for assessing the amount of vapor inhaled by the user through outlet 170; a flow sensor (e.g., a fluid flow sensor) for assessing the amount of medication drawn from a cartridge; a position sensor for assessing changes in the position of a float or plunger associated with the volume of medication; and a pH sensor for assessing the pH level of vapor flowing from a medication actuator (e.g., an atomizing mesh). Figure 14 In particular, an optical particle sensor (e.g., a laser particle sensor) or an ionization sensor 168 is shown, which functions within the turbidimeter's range of functions to assess the particle size distribution and concentration of aerosols or vapors flowing from a pharmaceutical actuator (e.g., a nebulizer), wherein the ionization sensor 168 can also be used to sense the concentration of active pharmaceutical components within aerosol droplets.

[0063] Now for reference Figure 15 The figure illustrates a perspective view of a hardware device (e.g., a nebulizer) according to various embodiments of the present disclosure, the hardware device having scalability and configured for use with a computer-implemented system for delivering and monitoring treatment protocols. Specifically, A shows the device 16 in a closed configuration. In various embodiments, the closed configuration is an inactive configuration. B shows the device 16 in an open configuration. In various embodiments, the open configuration is an active configuration.

[0064] Now for reference Figure 16 It shows a perspective cross-sectional view of a hardware device (e.g., a nebulizer) according to various embodiments of the present disclosure, the hardware device having scalability and being configured for use with a computer-implemented system for delivering and monitoring treatment protocols. Specifically, Figure 16 One or more control surfaces 1636 are shown near the drug actuator or atomizing actuator element 1832 (e.g., atomizing mesh). In various embodiments, the control surface 1636 is adjacent to the drug actuator or atomizing actuator element 1832. In various embodiments, the control surface 1636 and the drug actuator or atomizing actuator element 1832 are located below the storage / mixing chamber 1691. In various embodiments, the control surface 1636 and the drug actuator or atomizing actuator element are provided with sufficient geometry to generate a turbulent Venturi mixing zone 1637.

[0065] Computer-implemented systems In the various embodiments disclosed herein, systems, software, and methods for aerosol delivery are also generally related, including dynamically adjustable aerosol delivery and broad-spectrum delivery relying on precise real-time monitoring of control variables, which can be implemented via computer software or hardware. For more information on the systems, apparatus, and methods provided herein according to the various embodiments, please refer to the appendix.

[0066] Figure 1(See Appendix) A block diagram illustrating a computer system 100 on which embodiments of the present disclosure may be implemented. In various embodiments of the present disclosure, the computer system 100 may include a bus 102 or other communication mechanism for transmitting information, and a processor 104 coupled to the bus 102 to process information. In various embodiments, the computer system 100 may also include memory coupled to the bus 102, which may be random access memory (RAM) 106 or other dynamic storage device, for determining instructions to be executed by the processor 104. The memory may also be used to store temporary variables or other intermediate information during the execution of instructions to be executed by the processor 104. In various embodiments, the computer system 100 may also include a read-only memory (ROM) 108 or other static storage device coupled to the bus 102 for storing static information and instructions for the processor 104. A storage device 110, such as a magnetic disk or optical disk, may be provided and coupled to the bus 102 to store information and instructions.

[0067] In various embodiments, the computer system 100 may be coupled via bus 102 to a display 112, such as a cathode ray tube (CRT) or liquid crystal display (LCD), to display information to the computer user. An input device 114, including alphanumeric keys and other keys, may be coupled to bus 102 to transmit information and command selections to processor 104. Another type of user input device is a cursor control 116, such as a mouse, trackball, or cursor arrow keys, used to transmit directional information and command selections to processor 104 and to control cursor movement on display 112. The input device 114 typically has two degrees of freedom on two axes (a first axis (i.e., the x-axis) and a second axis (i.e., the y-axis)), allowing the device to determine its position in a plane. However, it should be understood that an input device 114 that allows for three-dimensional (x, y, and z) cursor movement is also contemplated herein.

[0068] According to certain embodiments of this disclosure, computer system 100 may provide a result in response to processor 104 executing one or more sequences of one or more instructions contained in memory 106. Such instructions may be read into memory 106 from another computer-readable medium or computer-readable storage medium (e.g., storage device 110). Executing the sequence of instructions contained in memory 106 may cause processor 104 to perform the processes described herein. Alternatively, hard-wired circuitry may be used in place of, or in combination with, software instructions to implement this disclosure. Therefore, embodiments of this disclosure are not limited to any particular combination of hardware circuitry and software.

[0069] As used herein, the terms "computer-readable medium" (e.g., data repository, data storage, etc.) or "computer-readable storage medium" refer to any medium that participates in providing instructions to processor 104 for its execution. Such media can take many forms, including, but not limited to, non-volatile media, volatile media, and transmission media. Examples of non-volatile media may include, but are not limited to, dynamic memory, such as memory 106. Examples of transmission media may include, but are not limited to, coaxial cables, copper wires, and optical fibers, including conductors constituting bus 102.

[0070] Common forms of computer-readable media include, for example, floppy disks, flexible disks, hard disks, magnetic tapes or any other magnetic media, CD-ROMs, any other optical media, punched cards, paper tapes, any other physical media with a perforated pattern, RAM, PROMs and EPROMs, flash memory EPROMs, other memory chips or memory cartridges, or any other tangible media from which a computer can read.

[0071] In addition to computer-readable media, instructions or data may be carried as signals on a transmission medium included in a communication device or system to provide a sequence of one or more instructions for execution to a processor 104 of computer system 100. For example, a communication device may include a transceiver having signals characterizing instructions and data. The instructions and data are configured to cause one or more processors to perform the functions outlined in this disclosure. Representative examples of data communication transmission connections may include, but are not limited to, telephone modem connections, wide area networks (WANs), local area networks (LANs), infrared data connections, NFC connections, etc.

[0072] It should be understood that the methods, flowcharts, diagrams and contents described herein can be implemented using a computer system 100 as a stand-alone device, or on a distributed network or shared computer processing resources (e.g., cloud computing network).

[0073] The methods described herein can be implemented in various ways depending on the application scenario. For example, these methods can be implemented in hardware, firmware, software, or any combination thereof. For hardware implementation, the processing unit can be implemented in one or more application-specific integrated circuits (ASICs), digital signal processors (DSPs), digital signal processing devices (DSPDs), programmable logic devices (PLDs), field-programmable gate arrays (FPGAs), processors, controllers, microcontrollers, microprocessors, electronic devices, other electronic units designed to perform the functions described herein, or combinations thereof.

[0074] In various embodiments, the methods of this disclosure can be implemented as firmware and / or software programs and applications written in common programming languages ​​such as C, C++, and Python. If implemented as firmware and / or software, the embodiments described herein can be implemented on a non-transitory computer-readable medium storing programs for causing a computer to perform the methods described above. It should be understood that the various engines described herein can be deployed on a computer system (e.g., computer system 100), whereby processor 104 will perform the analysis and determination provided by these engines based on instructions provided by any one or a combination of memory components 106 / 108 / 110 and user input provided via input device 114.

[0075] In describing the various embodiments, the specification may have presented methods and / or processes as a specific sequence of steps. However, a method or process should not be limited to the specific sequence of steps described herein, provided that it does not depend on the specific order of steps recorded herein. Other sequences of steps may exist, as will be understood by those skilled in the art. Therefore, the specific order of steps recorded herein should not be construed as a limitation of the claims. Furthermore, claims for methods and / or processes should not be limited to performing the steps in the order they are recorded, and it will be readily understood by those skilled in the art that the sequence of steps may be modified while still falling within the spirit and scope of the various embodiments. Similarly, any of the various system embodiments may be presented as a specific set of components. However, these systems are neither limited to a specific set of components nor to a specific configuration, communication, and physical orientation between them. It will be readily understood by those skilled in the art that these components may have various configurations and physical orientations (e.g., completely independent components, units and subunits of component groups, different communication modes between components).

[0076] Although specific embodiments and applications of this disclosure have been described in this specification, these embodiments and applications are merely exemplary and various variations may exist.

[0077] Exemplary embodiments Example 1: A hardware device for therapeutic drug delivery, comprising: a housing having an internal volume.

[0078] Example 2: According to the hardware device described in Example 1, the housing further includes a static part and a movable part; wherein, when in an inactive position, the static part and the movable part form a first internal volume; wherein, when in an active position, the static part and the movable part form a second internal volume, wherein the movable part is configured to move around the static part when in an active position to form the second internal volume.

[0079] Example 3: According to the hardware device described in Example 2, the second internal volume is larger than the first internal volume.

[0080] Example 4: According to the hardware device described in Example 2, the second internal volume is smaller than the first internal volume.

[0081] Example 5: According to the hardware device described in Examples 1-4, the housing further includes an air intake area, allowing air to be drawn into the interior of the hardware device.

[0082] Example 6: According to the hardware device described in Example 5, the air intake area enables laminar flow of air diluent to be generated in the internal volume of the housing.

[0083] Example 7: According to the hardware device described in Examples 5-6, the air intake area extends laterally along the housing and optionally enables laminar flow of air diluent to be generated in the internal volume.

[0084] Example 8: According to the hardware device described in Examples 5-7, the air intake area extends longitudinally along the housing and optionally enables laminar flow of air diluent to be generated in the internal volume.

[0085] Example 9: The hardware device according to Examples 1-2 further includes a storage / mixing chamber.

[0086] Example 10: According to the hardware device described in Example 9, the storage / mixing chamber is configured and set to mix an air volume per unit volume containing a concentrated group of drug droplets with air used to dilute the droplets in the volumetric flow, thereby reducing the droplet density per unit air volume.

[0087] Example 11: According to the hardware device described in Examples 9-10, the storage / mixing chamber further includes one or more fluid control surfaces, which are geometrically configured and set as turbulent Venturi mixing zones for generating drug droplets and air diluents.

[0088] Example 12: According to the hardware device described in Examples 9-11, the storage / mixing chamber further includes one or more fluid control surfaces and a drug actuator, the fluid control surfaces and the drug actuator being geometrically configured and set to generate a turbulent Venturi mixing zone for drug droplets and air diluent.

[0089] Example 13: The hardware device according to Examples 1-2 further includes an optical sensor.

[0090] Example 14: According to the hardware device described in Example 13, the optical sensor is configured and set to measure at least one of the following: droplet size distribution, droplet concentration per unit volume, dynamic droplet flow rate, and reagent concentration in each droplet.

[0091] Example 15: According to the hardware device described in Examples 13-14, the housing further includes a Venturi mixing region configured and set to provide a controlled sampling volume to the optical sensor.

[0092] Example 16: The hardware device according to Examples 1-2 further includes a logic / computing module.

[0093] Example 17: The hardware device according to Examples 1-2 further includes a logic / computation module configured to calculate the condensate loss rate based on measurement results from the optical sensor and one or more additional sensors.

[0094] Example 18: According to the hardware device described in Examples 16-17, the logic / computation module controls the power supply module to adjust the pulse period signal power applied to the pharmaceutical actuator, thereby compensating for the calculated condensate loss rate.

[0095] Example 19: The hardware device according to Examples 1-2 further includes at least one container.

[0096] Example 20: The hardware device according to Example 19 further includes: a cartridge module, including a drug carrier module component, the component including at least one container for mixing the drug with a suitable liquid drug carrier or diluent.

[0097] Example 21: The hardware device according to Examples 19-20 further includes multiple containers.

[0098] Example 22: The hardware device according to Example 21 further includes: a cartridge module, including a drug carrier module component, the component including a plurality of containers for mixing the drug with a suitable liquid drug carrier or diluent.

[0099] Example 23: A hardware device for therapeutic drug delivery, comprising: a storage / mixing chamber configured to mix an air volume per unit volume containing a concentrated cluster of drug droplets with air for diluting the droplets within the volume stream, thereby reducing the droplet density per unit air volume.

[0100] Example 24: According to the hardware device described in Example 23, the storage / mixing chamber (1691) includes a plurality of radially arranged fluid control surfaces (1636) having sufficient geometry to generate a turbulent Venturi mixing zone (1637) for pharmaceutical droplets and air diluent.

[0101] Example 25: A hardware device for therapeutic drug delivery, comprising: a power module configured to control the drug actuation rate and the corresponding drug dispensing rate per unit dose by adjusting the power of a pulse period signal supplied to a drug actuator according to instructions from a logic / computation module.

[0102] Example 26: A hardware device for therapeutic drug delivery, comprising: a multi-compartment storage container for a variety of different drugs and / or diluents / excipients or placebos.

[0103] Example 27: The hardware device according to Examples 23-24 further includes an air inlet of a specific size disposed at a specific optimized position along the side wall and / or bottom surface of the housing, allowing the microdroplet aerosol diluent (air) to flow into the storage / mixing chamber in a laminar flow form, thereby maintaining the laminar separation gap between the microdroplet aerosol and the inner side wall of the housing during use.

[0104] Example 28: The hardware device according to Example 25 further includes: one or more drug actuators, wherein the power module is configured to be communicatively connected to each drug actuator, thereby realizing proportional microdroplet mixing control of different drug aerosol flows.

[0105] Example 29: The hardware device according to Examples 23-26 further includes a cartridge module, including a drug carrier module component, said component including at least one container for mixing the drug with a suitable liquid drug carrier or diluent.

[0106] Example 30: A hardware device for therapeutic drug delivery, comprising: a vapor flow sensor capable of measuring the outflow rate and / or aerosol droplet concentration from an outlet.

[0107] Example 31: A hardware device for therapeutic drug delivery, comprising: a pressure sensor configured to measure the pressure difference and pressure change between the internal and external environments of the device.

[0108] Example 32: A hardware device for therapeutic drug delivery, comprising: a logic / computation module configured to determine / calculate a specific dose and / or total dose of a drug to be delivered to a patient based on input measurements of vapor density, vapor velocity, and liquid level in a drug storage tank.

[0109] Example 33: The hardware device according to Examples 23-32 further includes one or more sensors disposed near the drug actuator located on the inner surface of the housing, configured to evaluate the concentration of the drug formed by one or more actuating elements.

[0110] Example 34: A hardware device for therapeutic drug delivery, comprising: at least one sensor; said at least one sensor being operatively communicative to a logic / computing module; said at least one sensor being configured to detect at least one characteristic related to a user dispensing medication from said nebulizer; wherein the sensor is one or more of the following: a sensor for assessing the density of vapor flowing from the nebulizer mesh (e.g., a laser particle sensor or an ionization sensor); a flow sensor for assessing the amount of vapor inhaled by the user through the outlet (e.g., a pressure sensor or a volumetric flow sensor); a flow sensor for assessing the amount of medication drawn from the cartridge (e.g., a fluid flow sensor); a position sensor for assessing the positional change of a float or plunger associated with the volume of medication; and a pH sensor for assessing the pH level of vapor flowing from the nebulizer mesh.

[0111] Example 35: According to the hardware device of Example 35, the logic / computation module is configured to control the power supplied from the power source to the atomizer mesh or evaporator heating element / ultrasonic plate in response to calibration data received from a remote software environment. And / or, the logic / computation module is configured to control the power supplied from the power source to the atomizer mesh or evaporator heating element / ultrasonic plate in response to calibration data received from a remote software environment and in response to information acquired from one or more sensors.

Claims

1. A hardware device for therapeutic drug delivery, comprising: The shell has an internal volume.

2. The hardware device according to claim 1, wherein, The housing also includes a static part and a movable part; When in an inactive position, the static part and the moving part form a first internal volume; when in an active position, the static part and the moving part form a second internal volume, wherein the moving part is configured to move around the static part when in an active position to form the second internal volume.

3. The hardware device according to claim 2, wherein, The second internal volume is larger than the first internal volume.

4. The hardware device according to claim 2, wherein, The second internal volume is smaller than the first internal volume.

5. The hardware device according to claim 2, wherein, The housing also includes an air intake area, allowing air to be drawn into the hardware device.

6. The hardware device according to claim 5, wherein, The air intake area enables laminar flow of air diluent to be generated within the internal volume of the housing.

7. The hardware device according to claim 5, wherein, The air intake area extends laterally along the housing and optionally enables laminar flow of air diluent to be generated in the internal volume.

8. The hardware device according to claim 5, wherein, The air intake area extends longitudinally along the housing and optionally enables laminar flow of air diluent to be generated in the internal volume.

9. The hardware device according to claim 2, further comprising: Storage / mixing chamber.

10. The hardware device according to claim 9, wherein, The storage / mixing chamber is configured to mix an air volume per unit volume containing a concentrated cluster of drug droplets with air used to dilute the droplets within the volumetric flow, thereby reducing the droplet density per unit air volume.

11. The hardware device according to claim 9, wherein, The storage / mixing chamber also includes one or more fluid control surfaces, which are geometrically configured and set to generate turbulent Venturi mixing zones for pharmaceutical droplets and air diluents.

12. The hardware device according to claim 9, wherein, The storage / mixing chamber also includes one or more fluid control surfaces and a pharmaceutical actuator, which are geometrically configured and set to generate a turbulent Venturi mixing zone for pharmaceutical droplets and air diluent.

13. The hardware device according to claim 2, further comprising: Optical sensor.

14. The hardware device according to claim 13, wherein, The optical sensor is configured to measure at least one of the following: droplet size distribution, droplet concentration per unit volume, dynamic droplet flow rate, and reagent concentration within each droplet.

15. The hardware device according to claim 14, wherein, The housing also includes a Venturi mixing region configured to provide a controlled sampling volume to the optical sensor.

16. The hardware device according to claim 2, further comprising: Logic / Computation Module.

17. The hardware device according to claim 2, further comprising: A logic / computation module is configured and set to calculate the condensate loss rate based on measurements from the optical sensor and one or more additional sensors.

18. The hardware device according to claim 16, wherein, The logic / computation module controls the power supply module to adjust the pulse period signal power applied to the pharmaceutical actuator, thereby compensating for the calculated condensate loss rate.

19. The hardware device according to claim 2, further comprising: At least one container.

20. The hardware device according to claim 19, further comprising: A cartridge module, including a drug carrier module component, said component including at least one container for mixing a drug with a suitable liquid drug carrier or diluent.

21. The hardware device according to claim 19, further comprising: Multiple containers.

22. The hardware device according to claim 21, further comprising: The cartridge module includes a drug carrier module component, which includes multiple containers for mixing a drug with a suitable liquid drug carrier or diluent.

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