Drug delivery systems, devices and methods

Abstract

The electronic drug delivery system and method for use in a treatment program includes a mobile platform, a handheld inhalation delivery device having a controller circuit coupled to a power source, a sensor, an aerosolizer driver, and a rescue button, and a pod removably coupled to the delivery device, which generates an aerosol mixture from substances in the pod in accordance with the treatment program and delivers the aerosol mixture for inhalation by a user. The controller circuit individually and dynamically controls the aerosolizer drivers to generate signals that drive multiple thermal or non-thermal aerosolizers of the pod to generate individually tailored aerosol mixtures from multiple substances in the aerosolizer pod. The generated aerosol mixtures can have various percentages of substances and can have different aerosol droplet sizes during different portions of the treatment program.

Description

[Technical field]

[0001] (Incorporation by reference to priority application)

[0001] This application is a continuation-in-part of U.S. Patent Application No. 17 / 650,783, filed February 11, 2022. This application claims the benefit of U.S. Provisional Patent Application No. 63 / 263,863, filed November 10, 2021, No. 63 / 261,638, filed September 24, 2021, and No. 63 / 203,324, filed July 16, 2021. Each of the above applications is incorporated herein by reference in its entirety. All applications in which a foreign or domestic priority claim is identified in the Application Data Sheet filed with this application are incorporated herein by reference under 37 CFR 1.57.

[0002] FIELD OF THEINVENTION

[0002] The present disclosure relates to systems, devices, and methods for delivering a substance or combination of substances for medical or therapeutic purposes in accordance with a treatment program. More particularly, the present invention relates to systems, devices, and methods for delivering substances in a monitored and controlled treatment program that is individually tailored for a user and can be dynamically changed based on daily sensed characteristics of the user's activity and progress in the treatment program. [Background technology]

[0003] Description of Related Art

[0003] One or more drugs are often provided to a user for medical or therapeutic purposes. The drugs are typically administered by the user through the user's mouth (e.g., as tablets, chewables, lozenges, etc.), the skin (e.g., via gels, creams, sprays, and patches), or the user's nose (e.g., via an inhaler). In all of these administration programs, the user is often responsible for properly following the drug management program and tracking compliance with the program to ensure that the treatment is effective and safe, and thus proper administration of drugs using such methods can be highly unreliable. Some treatments do not require strict adherence to the program, while other programs require strict adherence for effective and safe treatment.

[0004]

[0004] Some addictions can be helped by certain treatment programs. Addiction can cause physical and mental harm. As an example, smoking causes many diseases, including cancer, heart disease, stroke, lung disease, diabetes, emphysema, and chronic bronchitis. Smoking is also known to increase the risk of immune system problems, such as tuberculosis, certain eye diseases, and rheumatoid arthritis. Smoking is one of the most common causes of preventable deaths worldwide. Non-smokers who are in close proximity to those who are can contract these diseases through second-hand smoke. Smoking and vaping (both of which will be generically referred to as "smoking" in this specification for ease of reference, unless the context or specific language indicates otherwise) are highly addictive and make quitting difficult. Many aids have been developed to help people quit smoking. For example, nicotine patches and nicotine gums can help people quit smoking. Certain devices (such as electronic cigarettes) have been developed as aids to quitting smoking, or at least to reduce some of the health risks, by providing a less harmful source of inhaled nicotine.

[0005]

[0005] Current devices used in smoking cessation, other addiction treatment programs, and other treatment programs are generally used in the same way for everyone, despite the individual's unique biological and psychological factors (e.g., smoking-related). For example, aerosol-producing devices are generally unable to dynamically provide tailored aerosol mixtures as required by highly individualized treatment programs. Moreover, such devices are unable to adequately monitor the use of the device and provide feedback to the system controlling the treatment program to ensure that medication is delivered accurately and that its use is tracked. Moreover, in smoking and other addiction treatment programs, such devices, while automatically monitoring and dynamically modifying the treatment program, do not allow the user to address overwhelming addictive urges. Thus, there is a need for improved processes for administering medication in a controlled, trackable treatment program, for example, to help users quit smoking or to stop other addictions. Summary of the Invention

[0006]

[0006] The systems, methods, and devices described herein each have several aspects, no single one of which is solely responsible for its desirable attributes. Without limiting the scope of the disclosure, some non-limiting features will now be briefly described. The methods and techniques described herein relate to systems, devices, and methods for the controlled delivery of a drug, agent, or active pharmaceutical ingredient (API) to a user as part of a treatment program. In some embodiments, the methods and techniques described herein relate to systems, devices, and methods for the controlled delivery of an aerosol mixture to a user during a treatment program.

[0007]

[0007] In one innovation, a delivery system for providing an aerosol mixture in a treatment program for smoking cessation includes a delivery device having a housing, a channel within the housing structured to receive air from an opening in the housing and transmit the air to an aerosolizer pod coupled to the delivery device, a flow sensor positioned to sense air flowing through the channel, first, second, and third aerosolizer drivers each having an electrical connection configured to electrically couple to a first, second, and third aerosolizer, respectively, of the aerosolizer pod coupled to the delivery device, a rescue button configured to provide a signal when actuated by a user to provide an additional dose of the aerosol mixture in accordance with the treatment program, a power source, and a controller circuit coupled to the power source, the controller circuit configured to control the controller to generate a signal for the aerosol mixture in accordance with the treatment program, the rescue button configured to generate a signal for the aerosolizer pod when actuated by a user, the rescue button configured ... mixture in accordance with the treatment program, and a controller circuit coupled to the power source. The controller circuit includes a hardware controller electrically coupled to the first, second, and third aerosolizer drivers, the flow sensor, and the rescue button, the hardware controller including a hardware processor and a non-transitory computer-readable medium in communication with the hardware controller, the non-transitory computer-readable medium storing treatment program information and configured to store executable instructions that, when executed, configure the hardware controller to individually control the three aerosolizer drivers to provide aerosol generating signals, respectively, to the first, second, and third aerosolizers of a pod coupled to the delivery device to generate an aerosol mixture based at least in part on the stored treatment program and information received from the flow sensor and the rescue button.

[0008] Various embodiments may include one or more additional aspects. In some embodiments, the housing includes an opening for receiving the aerosolizer pod therein, the housing configured to at least partially enclose the aerosolizer pod when the aerosolizer pod is disposed within the opening and coupled to the delivery device. In some embodiments, the housing includes a distal end and a proximal end, the opening for receiving the aerosolizer pod being at the proximal end of the housing. In some embodiments, the housing further includes the aerosolizer pod, the aerosolizer pod having a structure that is removably coupleable to the delivery device. In some embodiments, the aerosolizer pod further includes an ID chip, the delivery device further includes an aerosolizer pod interface configured to sense the ID chip and communicate the ID chip to a hardware controller to identify the aerosolizer pod and the substance contained therein. In some embodiments, the aerosolizer pod includes an aerosolizer system including a first, a second, and a third aerosolizer. In some embodiments, each of the first, second, and third aerosolizers includes an electrical connection configured to electrically couple to one of the first aerosolizer driver, the second aerosolizer driver, and the third aerosolizer driver of the delivery device. In some embodiments, the first, second, and third aerosolizers are thermal aerosolizers. In some embodiments, the first, second, and third aerosolizers are mechanical aerosolizers. In some embodiments, the aerosolizer pod includes a first container for holding a first substance, a second container for holding a second substance, and a third container for holding a third substance, and the first, second, and third containers are structured to supply the first, second, and third substances to the first, second, and third aerosolizers, respectively. In some embodiments, the first substance comprises free radical nicotine, the second substance comprises monoprotonated nicotine, and the third substance comprises a flavoring agent.

[0009] In some embodiments, the system further includes an aerosolizer pod having a structure that is removably coupleable to the delivery device, the aerosolizer pod including a distal end and a proximal end, an inlet at the distal end for receiving air flowing through the channel, a mixing chamber, an outlet at the proximal end for exhausting the aerosol mixture from the mixing chamber from the aerosolizer pod, and an aerosolizer system including first, second, and third aerosolizers, each having an electrical connection that electrically couples to a first, second, and third aerosolizer driver, respectively, when the aerosolizer pod is coupled to the delivery device. In some embodiments, the mixing chamber includes an intake opening in fluid communication with the first, second and third aerosolizers and an exhaust opening in fluid communication with the exhaust outlet, such that aerosols generated by the first, second and third aerosolizers can enter the mixing chamber through the intake openings, mix together and be transmitted out of the pod through the pod exhaust outlet.In some embodiments, the first aerosolizer includes a first container for holding a first substance, a first thermal aerosolizer configured to generate an aerosol from the first substance based on a signal received from the first aerosolizer driver, and a first passageway in fluid communication with the thermal aerosolizer and the mixing chamber for transferring an aerosol generated by the first thermal aerosolizer to the mixing chamber, and the second aerosolizer includes a second container for holding a second substance and configured to generate an aerosol from the second substance based on a signal received from the second aerosolizer driver. The third aerosolizer includes a third container for holding a third substance, a third thermal aerosolizer configured to generate an aerosol from the third substance based on a signal received from the third aerosolizer driver, and a third passageway in fluid communication with the third thermal aerosolizer and the mixing chamber for transmitting the aerosol generated by the third thermal aerosolizer to the mixing chamber. In some embodiments, the first substance includes a nicotine-based substance therein, and the second substance includes a nicotine-based substance therein. In some embodiments, the third substance includes a flavoring agent. In some embodiments, the controller circuit further comprises a transceiver, the controller circuit configured to receive treatment program information using the transceiver, and the controller circuit configured to provide a signal to generate an aerosol mixture including a portion of the first substance, the second substance, and the third substance contained in the aerosolizer pod based on the received treatment program information. In some embodiments, the controller circuit is further configured to provide a signal to generate an aerosol mixture having an aerosol droplet size from each of the first, second, and third aerosolizers based on the received treatment program information.

[0010] In some embodiments, the controller circuit is further configured to provide, based on the received treatment program information, a signal to generate an aerosol mixture from each of the first, second, and third aerosolizers for a first portion of the treatment program having droplets less than or equal to the first diameter, and to provide a signal to generate an aerosol mixture from each of the first, second, and third aerosolizers for a second portion of the treatment program having droplets less than or equal to the second diameter. In some embodiments, the controller circuit is further configured, based on the received treatment program information, to provide a signal to generate an aerosol mixture from each of the first, second, and third aerosolizers for a first portion of the treatment program having a majority of droplets less than or equal to the first diameter, and to provide a signal to generate an aerosol mixture from each of the first, second, and third aerosolizers for a first portion of the treatment program having a majority of droplets less than or equal to the second diameter. In some embodiments, the second portion of the treatment program follows the first portion of the treatment program, and the first diameter is smaller than the second diameter. In some embodiments, the first diameter is less than or equal to 1 μm, and the second diameter is greater than or equal to 10 μm. In some embodiments, the system further includes a button in electrical communication with the controller circuit, the controller circuit configured to activate the delivery device to provide the aerosol mixture when the button is activated, hi some embodiments, the button includes a fingerprint sensor, the controller circuit configured to activate the delivery device to provide the aerosol mixture when fingerprint information sensed by the fingerprint sensor matches the fingerprint sensor of a particular user.

[0011] Another innovation includes a delivery device including a housing, a channel within the housing structured to receive air from an opening within the housing and transmit the air to an aerosolizer pod coupled to the delivery device, a flow sensor positioned to sense air flowing through the channel, first, second, and third aerosolizer drivers each having an electrical connection configured to electrically couple to a first, second, and third aerosolizer, respectively, of the aerosolizer pod coupled to the delivery device, and a controller circuit coupled to a power source. and a user computing device including an application that communicates with the delivery system via the transceiver, the controller circuit including a transceiver electrically coupled to the first, second, and third aerosolizer drivers and the flow sensor, and a hardware controller, the controller circuit configured to individually control the first, second, and third aerosolizer drivers to provide aerosol generating signals to the first, second, and third aerosolizers to generate an aerosol mixture based at least in part on the treatment program received using the transceiver. In some embodiments, the system further includes a server system configured with a hardware processor and a non-transitory computer readable storage medium encoding a treatment program including instructions executable by an operating system for controlling generation of the aerosol mixture over time in accordance with the treatment program and providing treatment program information to the delivery system to control generation of the aerosol mixture by the delivery system. In some embodiments, the treatment program information provided to the delivery system includes information for individually controlling the first, second, and third aerosolizer drivers to provide signals to the first, second, and third aerosolizers coupled to the first, second, and third aerosolizer drivers, respectively, to generate a desired aerosol mixture of a first aerosol generated from a first substance, a second aerosol generated from a second substance, and a third aerosol generated from a third substance.In some embodiments, the treatment program information provided to the delivery system includes information for individually controlling the first, second, and third aerosolizer drivers to provide signals to the first, second, and third aerosolizers coupled to the first, second, and third aerosolizer drivers to generate first, second, and third aerosols having aerosol droplets of a diameter. In some embodiments, the treatment program information provided to the delivery system includes information for individually controlling the first, second, and third aerosolizer drivers to provide signals to the first, second, and third aerosolizers coupled to the first, second, and third aerosol drivers to generate first, second, and third aerosols having aerosol droplets of a first diameter for a first portion of time and having aerosol droplets of a second diameter for a second portion of time.

[0012]

[0012] Another innovation includes a method for smoking cessation comprising the steps of providing a delivery system including a delivery device, the delivery device including a housing, a channel within the housing, the channel structured to receive air from an opening within the housing and transmit the air to an aerosolizer pod coupled to the delivery device, a flow sensor positioned to sense air flowing through the channel, first, second, and third aerosolizer drivers configured to electrically couple to first, second, and third aerosolizers, respectively, of the aerosolizer pod coupled to the delivery device, a rescue button configured, when actuated by a user, to provide a signal indicating the user's need for an additional dose of the aerosol mixture, a power source, and a controller circuit coupled to the power source, the controller circuit including a hardware controller electrically coupled to the first, second, and third aerosolizer drivers, the flow sensor, and the rescue button, the hardware controller including a hardware processor and a non-transitory controller in communication with the hardware controller. and a computer readable medium, the non-transitory computer readable medium configured to store treatment program information and to store executable instructions that, when executed, cause the hardware controller to individually control three aerosolizer drivers to provide aerosol generating signals to first, second, and third aerosolizers, respectively, of a pod coupled to the delivery device to generate an aerosol mixture based at least in part on the stored smoking cessation treatment program and information received from the flow sensor and the rescue button. an aerosolizer pod including an aerosolizer system including first, second, and third aerosolizers, the pod being configured to be removably coupleable to a delivery device, each of the first, second, and third aerosolizers including an electrical connection configured to electrically couple to one of a first aerosolizer driver, a second aerosolizer driver, and a third aerosolizer driver of the delivery device; and a first container for holding a first substance;providing a delivery system including a second container holding a second substance and a third container holding a third substance, the first, second, and third containers being structured to deliver the first, second, and third substances to the first, second, and third aerosolizers, respectively, the first substance being free radical nicotine and the second substance being monoprotonated nicotine; and generating an aerosol mixture according to a smoking cessation treatment program, generating an aerosol mixture that is dynamically altered over a period of time to have different aerosol droplet sizes and different concentrations of the first, second, and third substances based at least in part on received signals from the flow sensor and the rescue button, and smoking cessation treatment program information stored in a non-transitory computer readable medium.

[0013]

[0013] Another innovation includes a method for smoking cessation comprising providing signals from a hardware controller in a handheld delivery device to first, second and third aerosolizer drivers in the delivery device to dynamically control first, second and third aerosolizers in a pod coupled to the delivery device to generate an aerosol mixture that is dynamically modified over a period of time to have different aerosol droplet sizes and different concentrations of the first, second and third substances in a container of the pod based at least in part on received signals from one or more flow sensors and a rescue button, and smoking cessation treatment program information stored in a non-transitory computer readable medium coupled to the hardware controller, the method being performed by the controller executing computer executable instructions stored on the non-transitory computer readable medium that, when executed, cause the hardware controller to provide signals to the first, second and third aerosolizer drivers in accordance with the smoking cessation program.

[0014]

[0014] Another innovation includes a delivery system for providing an aerosol mixture in a treatment program for smoking cessation, the delivery system including a pod including first, second, and third aerosolizers and first, second, and third containers in communication with the first, second, and third aerosolizers, respectively, each container holding a substance used to generate the aerosol mixture in accordance with the treatment program, and a delivery device, the pod being removably coupleable to the delivery device, the delivery device including a housing, a channel structured to receive air from an opening in the housing and communicate the air to an aerosolizer pod coupled to the delivery device, a flow sensor positioned to sense air flowing through the channel, first, second, and third aerosolizer drivers configured to electrically couple to the first, second, and third aerosolizers, respectively, of the pod when the pod is coupled to the delivery device, and a flow sensor configured to electrically couple to the first, second, and third aerosolizer drivers configured to electrically couple to the first, second, and third aerosolizers of the pod, respectively, when the pod is coupled to the delivery device, and a flow sensor configured to electrically couple to the first, second, and third aerosolizer drivers configured to electrically couple to the first, second, and third aerosolizer drivers of the pod when the pod is coupled to the delivery device, the ... configured to electrically couple to the first, second, and third aerosolizer drivers configured to electrically couple to the first, second, and third aerosolizer drivers configured to electrically couple to the first, second, and third aerosolizer a rescue button configured to provide a signal indicating a user's need for an additional dose of the aerosol mixture when activated by the power source, a power source, and a controller circuit coupled to the power source, the controller circuit including a hardware controller electrically coupled to the first, second, and third aerosolizer drivers, the flow sensor, and the rescue button, the hardware controller including a hardware processor and a non-transitory computer-readable medium in communication with the hardware controller, the computer-readable medium configured to store treatment program information and to store executable instructions, which, when executed, configure the hardware controller to individually control the three aerosolizer drivers to provide aerosol generating signals to the first, second, and third aerosolizers, respectively, to generate an aerosol mixture based at least in part on the stored treatment program and the information received from the flow sensor and the rescue button. In some embodiments, the three aerosolizers are thermal aerosolizers. In some embodiments, the three aerosolizers are mechanical aerosolizers.In some embodiments, the first container contains free radical nicotine and the second container contains monoprotonated nicotine.

[0015] Another innovation includes a computer-implemented method for providing a treatment program for smoking cessation, the method including the steps of generating a smoking cessation treatment program including a plurality of treatment periods based on received patient information including a nicotine metabolic rate; and communicating aerosol mixture information to a handheld delivery system that includes three substances used to generate an aerosol mixture provided to the patient based on the treatment program, the aerosol mixture information indicating the amount of each of the three substances to be included in the aerosol mixture and the droplet size of the aerosol droplets in the aerosol mixture for each of a plurality of treatment periods, the method being performed by one or more computer hardware processors that execute a plurality of computer-readable instructions stored on a non-transitory computer memory. In some embodiments, the method further includes generating an aerosol mixture on the delivery system based on the aerosol mixture information. In some embodiments, the method further includes receiving usage information from the delivery system and communicating updated aerosol mixture information to the delivery system based at least in part on the usage information.

[0016]

[0017] Another innovation is a method of operating a smoking cessation system or a vape smoking cessation system, the method including providing a smoking cessation system (e.g., having any of the embodiments and features described herein) and controlling aerosols generated by each of three aerosolizers based on a smoking cessation program and based on information received from one or more sensors to form an aerosol mixture in an aerosol mixing chamber.

[0017]

[0018] Another innovation includes a method of operating a handheld or vape smoking cessation system, the method including controlling aerosols generated by each of three or more aerosolizers of the aerosolizer system to form an aerosol mixture in an aerosol mixing chamber, the aerosol mixing chamber in fluid communication with an exhaust opening for providing the aerosol mixture to a user.

[0018]

[0019] Another innovation is a non-transitory computer-readable medium having instructions stored thereon that, when executed by a computer hardware processor, cause the computer hardware processor to perform some or all of the methods described herein.

[0019]

[0020] In one example, a technological innovation includes a non-transitory computer-readable medium for operating a smoking cessation system, the computer-readable medium having program instructions for causing a hardware processor to execute a method for providing signals from a hardware controller in a handheld smoking cessation device to first, second and third aerosolizer drivers in the handheld smoking cessation device to dynamically and individually control first, second and third aerosolizers in an aerosolizer pod coupled to the handheld smoking cessation device to generate an aerosol mixture that changes dynamically over a period of time. In another example, a technological innovation includes a non-transitory computer readable medium for operating a smoking cessation system, the non-transitory computer readable medium having program instructions for causing a hardware processor to execute a method for generating an aerosol mixture that is dynamically changed over a period of time, the method including providing signals from a hardware controller in a handheld smoking cessation device to first, second and third aerosolizer drivers in the handheld smoking cessation device to dynamically and individually control first, second and third aerosolizers in an aerosolizer pod coupled to the handheld smoking cessation device to control an aerosol mixture having one or more different droplet sizes and different concentrations of the first, second and third substances contained in the first, second and third aerosolizers, respectively, based at least in part on a smoking cessation program, input signals received from one or more sensors, and smoking cessation program information stored in the non-transitory computer readable medium coupled to the hardware controller.

[0020]

[0021] Additional embodiments of the present disclosure are described below with reference to the appended claims, which may serve as additional summary of the present disclosure.

[0021]

[0022] In various embodiments, a system is disclosed having a computer-readable storage medium having program instructions embodied therein and one or more processors configured to execute the program instructions to cause the one or more processors to perform operations including one or more aspects of the embodiments described above and / or below (including one or more aspects of the appended claims). The smoking cessation program may be included on a server system, or may be included on an application specific integrated circuit (ASIC) or other integrated circuit chip customized to include data flow processing and classification, and such an ASIC or other integrated circuit chip may be included in a network or network element.

[0022]

[0023] In various embodiments, computer-implemented methods are disclosed in which one or more aspects of the embodiments described above and / or below (including one or more aspects of the appended claims) are performed and / or carried out by one or more processors executing program instructions.

[0023]

[0024] In various embodiments, a computer program product is disclosed that includes a non-transitory computer-readable storage medium having program instructions embodied therein, the program instructions being executable by one or more processors to cause the one or more processors to perform operations including one or more aspects of the embodiments described above and / or below (including one or more aspects of the appended claims). [Brief description of the drawings]

[0024]

[0025] Features and advantages of the systems and methods described herein will become more fully apparent from the following description and appended claims considered in conjunction with the accompanying drawings. These drawings depict only some embodiments according to the present disclosure and are not to be considered as limiting its scope. In the drawings, like reference numbers or symbols typically identify like components unless the context dictates otherwise. The drawings are not intended to depict all features, structures, and / or components of the actual embodiments of the illustrated systems and components, nor are they intended to depict the relative dimensions of the illustrated elements, and the drawings may not be drawn to scale. [Figure 1] FIG. 1 shows an overview of an addiction treatment system, such as a smoking or vaping smoking cessation system ("Smoking Cessation System"). [Diagram 2] FIG. 2 is a schematic diagram of an example of a smoke-free system that includes a housing and an aerosolizer system (or "aerosolizer pod") that is removably coupleable to the housing. [Figure 3A] FIG. 3A is a schematic diagram of an example of a smoking cessation system showing an aerosolizer system coupled to a housing. [Figure 3B] FIG. 3B is a schematic diagram of the housing of the smoke-free system shown in FIG. 3A. [Figure 3C] FIG. 3C is a schematic diagram of the aerosolizer system of the smoking cessation system shown in FIG. 3A. [Figure 3D] FIG. 3D is a schematic diagram of a case and smoking cessation device including the components shown in FIG. 3A. [Figure 4] FIG. 4 is a schematic diagram of an example of a controller that may be used in a smoke-free system, showing communication lines between a hardware processor and other components of the smoke-free system. [Diagram 5] FIG. 5 is an example of a computer system that can be used to implement the functionality described herein. [Figure 6A] FIG. 6A is a diagram of a system for developing and implementing a smoking cessation program, according to one embodiment. [Figure 6B] FIG. 6B is a flow chart illustrating an example of a smoking cessation process, according to one embodiment. [Figure 6C] FIG. 6C is a flow chart illustrating another example of a smoking cessation process, according to one embodiment. [Figure 7A] FIG. 7A is a diagram illustrating an example of intersecting personalization areas utilized by a smoke-free system. [Figure 7B-1] FIG. 7B-1 is a table showing personalization parameters that affect how the body processes nicotine. [Figure 7B-2] FIG. 7B-2 is a table showing personalization parameters that affect how the body processes nicotine. [Figure 7C] FIG. 7C illustrates examples of primary, secondary, and other focus personalization areas utilized by a smoking cessation system. [Figure 7D] FIG. 7D illustrates an example of how nicotine is deposited in the body, according to one embodiment. [Figure 7E] FIG. 7E illustrates an example of how nicotine input and output are measured, according to one embodiment. [Figure 7F] FIG. 7F illustrates an example of the four main personalization parameters and their effect on nicotine deposited in the body. [Figure 7G] FIG. 7G is a diagram illustrating how the four main personalization parameters determine the three key variables. [Figure 7H] FIG. 7H shows the cascade D-2 ADME personalization model. [Figure 7I] FIG. 7I illustrates personalization parameters and device control variables used in the smoke-free system. [Figure 7J] FIG. 7J illustrates psychosocial co-factors when a user is pressured to begin a smoking experience. [Figure 7K]FIG. 7K is a diagram illustrating how personalization parameters and clustered persona characteristics are used to map smoking cessation fluid parameters. [Figure 7L] FIG. 7L shows nicotine concentration levels mapped to persona profiles and metabolic rates. [Figure 7M] FIG. 7M depicts bioavailability mapped to persona and metabolic rate. [Figure 7N] FIG. 7N shows aerosol droplet size mapped to persona profile and metabolic rate. [Figure 7O] FIG. 7O illustrates a starting combination of smoking cessation fluid variables defined for a unique user. [Figure 7P] FIG. 7P illustrates variables that can be applied to custom tailor a smoking cessation program. [Figure 7Q] FIG. 7Q illustrates a five-step process that can be implemented in a smoking cessation program. [Figure 8A] FIG. 8A is a block diagram showing an aspect of an onboarding process for a smoking cessation system, which may be the first part of a process to assist a user in quitting smoking, and examples of other subsequent parts of such a process are shown in FIGS. 10A-10L. [Figure 8B] FIG. 8B is a diagram illustrating aspects of data communication between a server system, a user device (mobile platform), and a delivery system, such as the server system, user device, and delivery system shown in FIG. [Figure 8C] FIG. 8C shows an example of a user interface displayed on a user device during an onboarding process according to some embodiments, in which questions are presented to the user and input related to smoking habits and personal information is received from the user, and the input is used to tailor a treatment program (in this example, a smoking cessation program). [Figure 8D]FIG. 8D shows an example of a user interface displayed on a user device during an onboarding process according to some embodiments, where questions are presented to the user and input related to smoking habits and personal information is received from the user, and the input is used to tailor a treatment program (in this example, a smoking cessation program). [Figure 8E] FIG. 8E illustrates an example of a user interface that is displayed on a user device during a device personalization process (calibration process), according to some embodiments. [Figure 8F] FIG. 8F shows an example of a user interface displayed on a user device during a treatment program, according to some embodiments. [Figure 9A] FIG. 9A shows an example of a delivery device having a pod that can be coupled to the delivery device. [Figure 9B] FIG. 9B shows a delivery device coupled to the pod shown in FIG. 9A. [Figure 9C] FIG. 9C further illustrates the device shown in FIG. 9B without the pod. [Figure 9D] FIG. 9D shows a pod that utilizes a non-thermal aerosolizer in a drug delivery device. [Figure 9E] FIG. 9E is a schematic diagram of an exemplary non-thermal circuit that may be used in a drug delivery system similar to the smoking cessation device shown in FIG. 3A. [Figure 9F] FIG. 9F is a flow chart illustrating an example of a drug dosage and delivery process, according to one embodiment. [Figure 10A] FIG. 10A is a graph showing smoking cessation journey duration and tapering parameters implemented in a smoking cessation program. [Figure 10B] FIG. 10B shows a dose graph, and FIG. 10B-1, 10B-2, and 10B-3 show a portion of FIG. 10B. FIG. 10B-1 shows a dose map specification for monoprotonated nicotine. FIG. 10B-2 shows a dose map specification for free base nicotine. FIG. 10B-3 shows a dose map specification for dimensionless values ​​of free base nicotine ratio and enantiomer ratio. [Figure 10C]FIG. 10C is a graph showing a hypothetical dose map specification for a monoprotonated nicotine dose. [Figure 10D] FIG. 10D is a graph showing a hypothetical dose map specification of free base nicotine dose (FND). [Figure 10E] FIG. 10E is a graph showing a hypothetical dose map specification of total nicotine dose (TND) (the sum of monoprotonated base and free base). [Figure 10F] FIG. 10F is a graph showing a hypothetical dose map specification of the free base nicotine ratio (FNR) (ratio of (free dose) / (total dose)). [Figure 10G] FIG. 10G is a graph showing a hypothetical dose map specification of the enantiomer ratio (ratio of (S-nicotine) / (R-nicotine)). [Figure 10H] FIG. 10H is a graph showing a hypothetical dose map specification for variable aerosol droplet size (ADS). [Figure 10I] FIG. 10I is a graph showing hypothetical dose map specifications of the previous six tapering variables combined, shown as a function of smoking cessation journey duration, based on initial values ​​of TND, FND, and FNR, and tapering TND reduction targets. [Figure 10J] FIG. 10J is a graph showing an example of a representative dose map specification for a patient who smokes tobacco (Patient 1 - Marlboro Red @ 2.6 mg / cigarette, FNR = 0.11, tapering regime TFND (constant FNR)). [Figure 10K] FIG. 10K is a graph showing an example of a representative dose map specification for a vaping patient (Patient 2 - Vapors' XROS & Zen-Haus e-liquid @ 17 mg / mL, FNR=0.84, tapering regime TFNDTFND (FNR constant)). [Figure 10L] FIG. 10L is a graph showing an example of a representative dose map specification for a patient who smokes tobacco (Patient 3 - Winston Blue @ 1.7 mg / cigarette, FNR = 0.05, tapering regime TFND early (FNR constant) TFNR (FND constant)). DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0025]

[0079] The following detailed description of various exemplary embodiments in conjunction with the drawings is intended as a description of various aspects of various exemplary embodiments, components, and methods implemented with a system for delivering a substance to a user according to an individually tailored treatment program, and is not intended to represent the only manner in which the various exemplary embodiments described herein may be implemented. The detailed description includes specific details for the purpose of providing a thorough understanding of the various exemplary embodiments of the present invention. However, it will be apparent to one of ordinary skill in the art that some aspects of the various exemplary embodiments of the present invention may be implemented without these specific details. In some cases, well-known structures and components are shown in block diagram form to avoid obscuring various examples of the various embodiments. It will be understood that unless a term is expressly defined in this disclosure to have an explained meaning, there is no intention, explicitly or indirectly, to limit the meaning of such a term beyond its plain or ordinary meaning. An element in a claim that does not explicitly recite a "means for performing" a particular function, or a "step for performing" a particular function, is not to be construed as a "means" or "step" clause as defined in 35 U.S.C. § 112.

[0026]

[0080] The present disclosure relates to a system and method for delivering a substance to a user according to an individually tailored treatment program. For ease of reference, unless otherwise indicated, the terms substance, drug, agent, or active pharmaceutical ingredient (API) are used interchangeably herein, and all may be referred to as "substance", unless otherwise indicated expressly or by context. As a specific example, a system and method for delivering a substance to a user for a smoking cessation treatment program is described. The disclosed system, device, and process can also be used in many other treatment programs, such as, but not limited to, hormone replacement programs, programs for other addiction treatments, etc., where it is desirable to educate the patient, control the administration of multiple drugs (e.g., substances, drugs, APIs, etc.) to the patient, and automatically monitor the drugs provided for accurate tracking of the patient in the treatment program.

[0027]

[0081] Thus, by way of example, in some embodiments, the system, device, and method are employed to assist a user to quit smoking or vaping. For ease of reference, "smoking" as used herein is used in reference to smoking and / or vaping. Reference to a "smoking cessation device," "smoking cessation system," or "smoking cessation method," or similar expressions, refers to either or both of a device, system, or method that can be used to facilitate a user to quit smoking or to quit vaping. For example, a device, system, or method that can be implemented in a cloud-based (or server-based) system for assisting a user to quit smoking or vaping, as illustrated in FIG. 1 and described in further detail in subsequent figures. As mentioned above, the smoking cessation system, device, and process can be implemented in a smoking cessation program, or a vaping smoking cessation program, and the present system, device, and process can also be used to address and quit many other types of addictions. For example, the present systems, devices, and processes can be used in many types of addiction cessation programs that benefit from having an individually tailored program based on the physiological and psychological characteristics of the user, administering a mixture of multiple substances to the user via an inhalation device, automatically monitoring the user's progress in the smoking cessation program daily, and providing near-instantaneous feedback to the user throughout each day of the smoking cessation program, if desired. Thus, while many of the examples herein relate to smoking cessation programs or vaping smoking cessation programs, the applications of the disclosed systems, devices, and processes are not limited to these applications. For ease of reference, "smoking" is used herein to refer to either or both smoking and vaping, unless otherwise indicated explicitly or by the context of the present disclosure, and "smoking cessation programs" refer to smoking and / or vaping cessation programs. In addition, smoking is not limited to tobacco products, but instead applies to any substance or material that can be smoked, atomized, aerosolized, or sprayed and inhaled by a user.

[0028]

[0082] The difficulty of quitting smoking is well known. A smoker's chances of success in their quit attempt are greatly increased if both the physiological and psychological aspects of smoking are addressed. To date, the physiological and psychological aspects of smoking cessation have generally been addressed at least somewhat separately. As a result, many smokers attempt to quit smoking or vape using one or the other. Also, the lack of integration of physiological and psychological aids reduces the effectiveness of smoking cessation. Furthermore, in many, if not all, smoking cessation programs, monitoring of users' smoking behavior is based on information provided by the user, not collected objectively. User-provided information may be inconsistent and inaccurate, at least because it is unreliable to collect and may even be false information.

[0029]

[0083] The systems, devices, and methods disclosed herein address these and other problems. Advantageously, a user's activity can be objectively monitored to collect accurate and detailed information about the user's use of the smoking cessation device as the user progresses through the smoking cessation program, the collected information relating to smoking cessation device usage characteristics that the user would not be able to collect themselves. In embodiments of the disclosed smoking cessation program, there is "onboarding" that personalizes the smoking cessation program based on the user's personal characteristics, which may be determined from genetic, user interviews and / or testing. For example, for smoking, these may include one or more of nicotine dependence, urge strength, perceived sensation of smoking, gender, race / ethnicity, nicotine metabolic rate (NMR), environment (e.g., air quality, pollution index, work environment), age, comorbidities, body mass index (BMI), fat tissue percentage, nicotine consumption, puff topology, medications, oral contraceptive use, menopausal status, sleep patterns, exercise profile, and special diets, nutritional, and eating patterns. These and other factors are illustrated in Figures 7A-7P, which disclose aspects of the individualization of smoking cessation treatment programs, behavior change goals, and treatment program steps. For example, an exemplary smoking cessation process is disclosed that includes onboarding a user to a smoking cessation program, tobacco tapering, nicotine tapering, placebo use, and relapse prevention (see, e.g., FIG. 7Q). Information related to onboarding is also described with reference to at least FIG. 8A.

[0030]

[0084] Thus, in one embodiment, the treatment system can provide an individually tailored, dynamically controlled smoking cessation program to assist a user in quitting smoking. The system can be a server-based system (e.g., a cloud-based system) that executes at least a portion of the treatment program. The system can also include a user device (a computer) that communicates with the server-based system. The user device includes a display that can provide information related to the treatment program to the user. The system can also include a delivery device (e.g., an inhalation device) that administers the aerosol mixture to the user based on the treatment program. The delivery device can include components for providing the aerosol mixture to the user and monitoring the user of the delivery device, a (computer) hardware controller, and one or more sensors. Signals from the sensors are used to monitor the user's use of the delivery device, which can be used to determine the user's progress through the treatment program and dynamically adjust the treatment program, if necessary. For example, the hardware controller of the delivery device can monitor and record the number of "puffs" the user takes from the delivery device, determine the flow rate of air provided to the user during a puff, determine the duration of each puff (e.g., the length of time of a given amount of airflow), determine the total inhalation time (e.g., cumulative), and / or determine the amount of substance taken by the user based on control of the individual aerosolizers of the delivery device. Information indicative of changes in the rate of airflow during a puff can also be determined and used to determine when to generate the aerosol mixture for the most effective inhalation of the aerosol mixture. Information sensed by sensors of the delivery device (e.g., flow rate sensors, ambient temperature, and / or ambient pressure, etc.) can also be communicated to the user device and server system and used to modify (e.g., optimize) the treatment program. Information generated from the delivery device can be communicated to the user device (e.g., via a Bluetooth link), and certain information related to the user's use of the delivery system can be displayed on the user device. Information received by the user device can also be communicated to the server system for use in the treatment application.

[0031]

[0085] The systems described herein may include a delivery device configured to control an aerosolizer system that may have multiple aerosolizers. The aerosolizer system may be incorporated into a pod (sometimes referred to herein as an "aerosolizer pod"). In some examples, the pod includes an aerosolizer system with two aerosolizers, each with a corresponding container that holds a substance (e.g., a fluid) that is provided to the aerosolizer for use in generating an aerosol. In some implementations, the aerosolizer system has two or more containers that correspond to each aerosolizer, such that fluids held in the two or more containers are provided to a single aerosolizer. Each container may hold a substance (e.g., a drug, a medication, etc.) that needs to be provided to a user according to a treatment program. In some examples, the containers hold the same substance, but typically hold different substances so that an aerosol mixture of different substances can be administered to a user. In one example of a delivery device used in a smoking cessation treatment program, the delivery device includes two aerosolizers and two containers (one for each aerosolizer). The first container may hold a first fluid that includes monoprotonated nicotine. The first fluid may also include a flavoring agent (e.g., any substance that provides a flavor that is perceived by a user when inhaled as an aerosol). The second container may hold a second fluid that includes free radical nicotine. The second fluid may also include a flavoring agent (e.g., any substance that provides a flavor that is perceived by a user when inhaled as an aerosol). In some examples, including the examples shown in Figures 3A, 3B, 3C, and 4, the aerosolizer system includes three aerosolizers. In some examples, the aerosolizer system may include four or more aerosolizers. Each aerosolizer is associated with a substance and generates an aerosol from the associated substance. The delivery device is configured to individually control each aerosolizer to generate an aerosol mixture based on a treatment program (e.g., a smoking cessation treatment program) that is individually tailored by the multiple aerosolizers.That is, the delivery device is configured to control the aerosolizers according to a treatment program to generate an aerosol mixture containing an amount of two or more substances. The delivery device is configured to individually control each aerosolizer according to a treatment program to generate an aerosol mixture containing an amount of two or more substances. In addition, in some embodiments (e.g., when the aerosolizers are thermal-based aerosolizers), the delivery device can individually control each aerosolizer according to a treatment program to generate an aerosol having a desired droplet size such that the resulting aerosol mixture contains droplets of a desired size, which affects where the aerosol is deposited in the user's mouth, throat, and / or lungs. Additional details and specific exemplary embodiments of the treatment system, delivery system, user device, and associated methods are described below.

[0032]

[0086] Although various exemplary embodiments of certain aspects are described herein, numerous variations, combinations, and permutations of these aspects are within the scope of the disclosure. Although certain benefits and advantages of certain aspects are mentioned, the scope of the disclosure is not intended to be limited to any particular benefit, use, or purpose.

[0033] (Example of a smoking cessation treatment system)

[0088] FIG. 1 illustrates an example of a system 10 that can be used to accurately and dynamically administer a substance according to a treatment program, monitor a patient's substance use throughout the treatment program, and provide feedback to the patient or others regarding the patient's progress in the treatment program. For ease of reference, the term "substance" provided or administered as used herein is a broad term that refers to a drug, medication, API, or another substance provided to a user by a delivery device as part of a treatment program. Exemplary embodiments are described that include systems, delivery devices, and methods for smoking cessation treatment programs. The smoking cessation treatment programs include cessation of smoking of any kind, including vaping using an electronic device, or inhalation of any kind of tobacco or non-tobacco product. Although the exemplary embodiments are for smoking cessation treatment programs, the described systems, devices, and methods are not limited to smoking cessation, but instead can be used for other types of treatment programs in which a substance is administered to a patient over a period of time. In particular, treatment programs in which a combination of substances is administered to a patient over a period of time, with the amount of substance being dynamically altered over time based on the treatment program. Examples of other treatment programs can include treatment programs for hormones or hormone replacement, drug addiction, allergies, pain relief, and the like.

[0034]

[0089] 1 illustrates example components of a treatment system ("system") 10 and communication links that may exist between the components. In this example, system 10 includes a server system 25, a delivery system 100 used by a user 30, and a user device 15. One or more advisors or physicians 35 can also receive information related to the treatment program and the user's progress in the smoking cessation program and provide input to the smoking cessation program or user 30. In some embodiments, system 10 can also include sensors 17 capable of communicating with delivery system 100 and / or user device 15.

[0035]

[0090] The components of the system 10 may communicate via a network 20 and one or more communication links. Examples include a communication link 40 between the delivery system 100 and the user device 15, a communication link 41 between the user device 15 and the network 20, a communication link 43 between the advisor 35 and the network 20, and a communication link 44 between the server 25 and the network 20. In an embodiment having a sensor 17, a communication link 46 may exist between the sensor 17 and the user device 15, and / or a communication link 47 may exist between the sensor 17 and the delivery system 100. One or more portions of the network 20 and the communication links 40-44, 46, 47 may be wired or wireless communication links, and may include Wi-Fi, Bluetooth, cellular, or any suitable communication link. The network 20 may be, for example, the Internet, another local area network (LAN), or a wide area network (WAN). In some examples, the delivery system 100 may be included directly in the network 20 via a communication link 42 (e.g., a wireless communication link).

[0036]

[0091] In this embodiment, the server 25 is configured with a smoking cessation treatment program tailored to the individual user. As described below (see, e.g., Figures 7A-7Q, 8), at the start of the treatment program, the user is "on-boarded" and an individually tailored program is generated using factors specific to the user (see, e.g., one or more of the factors as shown in Figures 7A, 7B-1, and 7B-2). The server 25 provides information to the user device 15 for operating the treatment program, and the user device 15 provides information to the delivery system 100, which may include software updates, revised treatment program information and control parameters, etc. During the treatment program, use of the delivery system 100 is monitored by the delivery system 100 using one or more sensors incorporated into the delivery system 100. Figures 3A, 3B, and 4 show examples of sensors that may be included in the delivery system 100. Information related to the treatment program may be communicated from the delivery system 100 to the user device 15 and then to the server 25. Information received by the server 25 may be used by the server 25 to monitor and / or modify the smoking cessation program. The information received by server 25 may also be used to provide reports to advisor 35. Additionally, the information received by server 25 for each user may be used as information to modify the overall parameters of the treatment program for other users. For example, information from hundreds, thousands, tens of thousands or more users may be used to increase the efficiency and effectiveness of the treatment program for current and / or new users. In some examples, machine learning processes may be used with a data set of information for multiple users to determine the parameters of the treatment program.

[0037]

[0092] The user device 15 can be a smartphone, tablet computer, laptop computer, or other mobile computing device. The user device 15 can also be a desktop computer, a dedicated computer in the physician's facility, or other suitable computing resource. In some preferred embodiments, the user device is a mobile computing device that the user can have handy with them at all times, or most of the time (e.g., a smartphone). The user device 15 can provide treatment program information to the smoking cessation (or "delivery") device 100, including information used to control the production of an aerosol mixture from multiple aerosolizers, which the delivery system 100 controls to produce. The aerosolizers can be dynamically controlled to provide the desired aerosol mixture required by the smoking cessation program. In some embodiments, the user device 15 can execute at least a portion of the smoking cessation program, for example, through an app running on the user device 15. The user device 15 includes a display and, based on the received information, provides the user 30 with specific smoking cessation program information on various graphical user displays (GUIs) on the display, for example, information related to the user's progress or information encouraging the user to adhere to the smoking cessation program. The user device 15 may also receive information from the delivery system 100 relating to the user's use of the device (including information from sensors on the delivery system 100) and communicate some or all of the received information to the server 25. As noted above, the user device 15 may communicate changes / revisions to the smoking cessation program and related information, including software revisions or new software, to the smoking cessation system 100, including information the user device 15 receives from the server 25.

[0038]

[0093] In this embodiment, the delivery system 100 is an aerosol generating inhalation type device used by the user 30 to assist the user 30 in quitting smoking or vaping. The delivery system 100 may include a delivery device 109 and an aerosolizer pod 150 (e.g., as shown in FIG. 2). In some embodiments, the delivery device includes multiple aerosolizers, and the pod includes a container that holds a substance (e.g., a fluid) that is provided to the aerosolizers. In the embodiment shown in FIGS. 2, 3A-3C, the delivery device 109 includes a controller, one or more sensors, and other components used to control the generation of the aerosol mixture, and the pod 150 includes multiple aerosolizers and multiple containers that each house a substance that is provided to the aerosolizers.

[0039]

[0094] The delivery device 109 and the pod 150 are configured to be coupled together such that the delivery device 109 can provide control signals to the pod 150 to control the aerosolizers in the pod 150 to generate the aerosol mixture according to the treatment program. An example of the delivery device 109 and an aerosolizer pod 150 having three aerosolizers is shown in FIGS. 3A-3C. The delivery device 109 can include structures and various sensors and components used to monitor the use of the smoking cessation device and implement the treatment program, including modifications to the smoking cessation program, if necessary. In one example, the delivery device 109 can include a housing having a distal end and a proximal end, and a channel having an opening in a portion of the housing (e.g., the distal end of the housing or a central portion of the housing) to receive air.

[0040]

[0095] The delivery device 109 may also include an opening (e.g., on a proximal end of the housing) configured to receive an aerosolizer pod (e.g., pod 150 of FIG. 2). The housing may be configured to at least partially surround the pod when the pod is disposed within the housing. The smoking cessation device may include a plurality of sensors. The sensors may include, for example, one or more of a flow sensor disposed to sense air flowing through the channel, one or more density sensors for sensing a density of the aerosol generated by the one or more aerosolizers, one or more temperature sensors configured to sense a temperature of the aerosol generated by the one or more aerosolizers (respectively), an ambient temperature sensor, an ambient pressure sensor, a fingerprint sensor, a carbon dioxide sensor, and / or an oxygen sensor.

[0041]

[0096] The delivery system 100 may also include multiple aerosolizer drivers ("drivers") configured to electrically couple to and drive the aerosolizers in the pod. In some embodiments, the delivery system 100 includes two or more drivers to control two or more aerosolizers in the pod. In some embodiments, the delivery system 100 includes three drivers to control three aerosolizers in the pod. In some embodiments, the delivery device 100 includes four or more drivers to control four or more aerosolizers in the pod. The controller circuitry of the delivery device 100 may include a hardware controller coupled to flow sensors, other sensors, aerosolizer drivers, a rescue button, and a fingerprint sensor. The hardware controller may include a hardware processor and a non-transitory computer-readable medium in communication with the hardware controller, the computer-readable medium configured to store smoking cessation program information and executable instructions that, when executed, cause the hardware controller to execute a smoking cessation program including receiving input signals from the flow sensor, other sensors, and rescue button, and individually controlling the aerosolizer drivers to provide aerosolizer generating signals for controlling the multiple aerosolizers of the aerosolizer pod to generate an aerosol mixture based on at least the received input signals and the smoking cessation program information. These and other components are described in more detail below, e.g., in Figures 2-5. Figure 1 shows a simplified diagram of a treatment system 10 including only one delivery system 100 associated with one user 30. In operation, the system 10 may include multiple delivery systems 100, each associated with a different user, and the server 25 may include a treatment program configured to control each of the multiple delivery systems according to the associated user's individual treatment program.

[0042]

[0097] Sensor(s) 17 may optionally be included in the system. Sensor 17 may include one or more sensors that sense a characteristic of the user and communicate information of the sensed characteristic to delivery system 100 and / or user device 15. In various embodiments, sensor 17 may include a patch, wearable, or any other sensor capable of sensing a characteristic of the user. As non-limiting examples, the sensor may be configured to sense a characteristic (e.g., sugar level, nicotine level, pH, drug / medication / hormone level, etc.) in the user's blood, sweat, urine, or saliva.

[0043]

[0098] FIG. 2 is a schematic diagram of an example of a delivery device 109 and an aerosolizer system (or "pod") 150 that may be used in the smoking cessation system 10. As described in more detail with reference to FIG. 3A, the delivery device 109 includes components for implementing a treatment program, including components for controlling a plurality of aerosolizers in the pod 150 to generate an aerosol mixture according to the treatment program and then inhaled by the user. The pod 150 is configured to be removably coupled to the delivery device 109. The pod 150 may be a consumable item. During a treatment program, a series of pods may be provided to the user in the delivery device. Each of the pods may include one substance or multiple substances. As dictated by the treatment program, the substances in the series of pods provided to the user may be the same in each pod, or the same in some pods, or none of the pods may be the same.

[0044]

[0099] In this example, the pod 150 is at least partially inserted into and coupled to the delivery device 109. Also in this example, when the pod 150 is coupled to the delivery device 109, an aerosolizer driver in the delivery device electrically connects to a corresponding aerosolizer in the pod 109. The aerosolizer driver 110 (FIG. 3A) can independently and separately provide signals to each aerosolizer 152 in the pod 109, thus generating a desired aerosol mixture of different substances in the multiple aerosolizers of the pod 150 in accordance with a smoking cessation program. For example, the aerosolizers 110 can be independently controlled to generate an aerosol mixture having different portions (e.g., percentages) of the various substances in the three receptacles 159 (FIG. 3A) of the pod 150. Also, each aerosolizer 152 can be independently controlled to generate an aerosol having different droplet sizes. Other configurations are possible. For example, in some embodiments, an aerosolizer can be part of the delivery system 100, where the pods contain containers of substance and when the pods are inserted into a delivery device, the substance in each pod is delivered to a corresponding aerosolizer in the delivery device.

[0045]

[0100] The delivery device 109 includes a distal end 105 having an opening 106 for receiving ambient air into the delivery device 109. The delivery device 109 is configured to have one or more air transmission channels such that air received through the opening 106 is supplied to the pod 150. The pod 150 may also include one or more air transmission channels for supplying air to each aerosolizer in the pod 150. The delivery device 109 includes a second opening 105 in the housing 102 configured to receive the pod 150 such that at least a portion of the pod 150 is disposed within the housing 102 with the pod 150 coupled to the housing 109. The pod 150 includes an opening 154 at the distal end 151 for receiving air passing through the delivery device 109. The pod 150 further includes an opening 164 at its distal end 153 for providing an aerosol mixture to a user. Examples of certain components that may be included in the delivery device 109 and pod 150 are shown in FIGS.

[0046]

[0101] An example of a delivery device 109 and a pod 150 coupled to the delivery device 109 and used as the delivery system 100 of the smoking cessation system 10 is illustrated in FIGS. 3A-3D. Specifically, FIG. 3A illustrates an example of a delivery device 109 with the pod 150 inserted into and coupled to the delivery device 109. FIG. 3B further illustrates the delivery device 109 illustrated in FIG. 3A. FIG. 3C further illustrates the pod 150 illustrated in FIG. 3A. FIG. 3D illustrates a case 165 that may be used to house the delivery device 109 and the pod 150. In various embodiments, the case 165 may include one or more additional components to facilitate use of the delivery device 109. Referring to FIG. 3A, in this example, when the pod 150 is coupled to the delivery device 109, the entire pod 150 is disposed within the housing 102. In other examples, when the pod 150 is coupled to the delivery device 109, a portion of the pod 150 may extend from the proximal end 103 of the delivery device 109. In this example, the pod 150 is coupled to the delivery device 109 such that it is in electrical communication with the delivery device 109 and in fluid communication with the airflow into and through the housing 102 (e.g., through opening 106, through channel 104, and through opening 108).

[0047]

[0102] Many components and structures may be disposed within the housing 102 of the delivery device 109, including but not limited to those shown in, for example, FIGS. 3A and 4. In this example, the delivery device 109 includes a channel 104 for supplying ambient air to the pod 150, the channel having a distal end 122 at the distal end 101 of the housing 102. The channel extends from an opening 106 toward a proximal end 107 of the channel to an opening 108. When the pod 150 is within the housing 102, the air intake 154 of the pod 150 is aligned with the opening 108 such that air is transferred through the channel 104 to the pod 150. In other examples, instead of a single opening 106, the delivery device 109 may include one or more openings 106 and / or one or more channels 104 for receiving air into the housing 102 and transferring the air to the pod 150. In some embodiments, the opening 106 may be disposed in a different portion of the housing, rather than at the distal end 101. In one example, the housing may include one or more openings 106 in a side of the housing 102 instead of or in addition to the distal end 101. In some embodiments, the one or more openings 106 are located at or near a gap between the housing 102 and the pod 150. The delivery device 109 also includes an opening 105 in the housing 102 on the proximal end 103 of the delivery device 109 that is structured to allow the pod 150 to be placed into the housing 102 through the opening 105. In this example, the delivery device 109 includes a cavity 140 that extends into the housing 102 from the proximal end 103 of the housing 102. The cavity 140 and the walls of the housing 102 surrounding the cavity are structured to receive and retain the pod 150.

[0048]

[0103] The delivery device 109 also includes a controller circuit 130 connected to the power source 114. The controller circuit 130 can include one or more hardware processors and non-transitory computer-readable media, for example, as described with reference to FIG. 5. The power source 114 can include, for example, a battery, a capacitor, a supercapacitor, or another energy storage medium, or a combination thereof. The power source 114 can be configured to provide power to the pod 150 when the pod 150 is coupled to the delivery device 109. In some examples, the pod 150 also includes a power source. The controller circuit 130 is in communication with one or more sensors and receives information (e.g., signals) from the sensors that the controller circuit 130 can use (at least in part) to operate the treatment program. For example, the delivery device 109 can include a flow sensor 112 positioned and configured to sense airflow into the delivery device 109 through the channel 104. The controller circuit 130 is connected to the flow sensor 112 and receives information indicative of the amount of air passing through the channel 104 from the flow sensor 112. Based on the information from the flow sensor 112, the controller circuit 130 can determine information indicative of a user's use of the smoking cessation system. For example, a "puff" (inhalation by a user of air / aerosol from the smoking cessation system), a puff duration, and / or a puff volume may be determined by the controller circuit 130 based on the information from the flow sensor 112. A puff profile may also be determined by the controller circuit 130 based on the information from the flow sensor 112. A "puff profile" refers, at least in part, to how the airflow changes during the duration of a puff. For example, whether the puff profile (e.g., airflow as a function of time) is a square wave, trapezoidal shape, sinusoidal shape, etc. The determined puff frequency, puff duration, puff volume, and / or puff profile may be used by a smoking cessation program to dynamically tailor the smoking cessation program to the needs of a particular user.Any signals / information received by the controller circuit 130 may be communicated to one or more of the user device 15 and the server 25 and used to monitor the user's progress in the smoking cessation program and may be used to make changes to the smoking cessation program.

[0049]

[0104] In this example, the delivery device 109 is configured for use with a pod 150 having three aerosolizer units ("aerosolizers") 161 (as shown in the example of FIG. 3C). Each aerosolizer 161a-c is capable of generating an aerosol from a substance contained in the pod 150. In this example, each aerosolizer 161a-c includes a heating element 152a-c (e.g., a resistive heating element) that is controlled by the controller circuit 130 via the aerosolizer drivers 110a-c and can generate an aerosol in accordance with a smoking cessation program. The aerosol communicates through the passages 156a-c and enters the mixing chamber 162 via the mixing chamber inhalation openings 170a-c (FIG. 3C), where it forms an aerosol mixture that can be inhaled by a user. Each aerosolizer driver 110a-c can interact with a corresponding aerosolizer 161a-c to generate some or all of the aerosol mixture such that the aerosol mixture can include any proportion of the multiple substances in the aerosolizer. In some embodiments, the temperature value is determined by the controller circuit 130 for each aerosolizer 161 by using the heating elements 152 as temperature sensors. For example, by sensing the change in resistance (or impedance) value of the heating elements 152 as the temperature of the heating elements 152 increases and correlating the resistance value to temperature. Other embodiments may sense the temperature of the aerosolizers in different ways. For example, in some embodiments, the delivery device 109 may include temperature sensors 158a-c (shown in dashed lines) configured to sense the temperature of the aerosol generated by the three aerosolizers 161a-c of the pod 150. The temperature sensors 158a-c may be positioned on the delivery device 109 such that, when the pod 150 is coupled to the delivery device 109, each temperature sensor 158a-c is adjacent to one of the passages 156a-c that convey the aerosol from the heating elements 152a-c to the mixing chamber 162 of the pod 150. The delivery device 109 may also include density sensors 160 a - c configured to sense the density of the aerosols generated by the three aerosolizers 161 of the pod 150 .The density sensors 160a-c may be positioned on the delivery device 109 such that, when the pod 150 is coupled to the delivery device 109, each density sensor 160a-c is positioned adjacent to one of the passageways 156a-c that convey aerosol from the heating elements 152a-c of the pod 150 to the mixing chamber 162 of the pod 150. In some embodiments, the density sensors 160a-c may be optical sensors.

[0050]

[0105] The delivery device 109 may also include a fingerprint sensor 118 connected to the controller circuit 130 and used to sense a user's fingerprint to unlock the delivery device 109. Additionally, the delivery device 109 may include an ambient temperature sensor 405 within the ambient pressure sensor 407, and the controller circuit 130 may be configured to use information from the ambient temperature sensor 405 within the ambient pressure sensor 407 to control the smoking cessation program provided to the user. For example, the controller circuit 130 controls the aerosol mixture generated by the pod 150 based at least in part on the ambient temperature and / or the ambient pressure.

[0051]

[0106] In some examples, the delivery device 109 also optionally includes a carbon dioxide sensor 121 coupled to the controller circuit 130 and providing a signal to the controller circuit 130 indicative of the amount of carbon dioxide. The delivery device 109 may also include a control (e.g., a button, or a fingerprint sensor 116) for activating the carbon dioxide sensor 121. In operation, after activating the sensor, the user exhales into the opening 106 to provide a flow of air to the carbon dioxide sensor 121, which provides a signal to the controller circuit 130. Information from the carbon dioxide sensor 121 may be used in a smoking cessation program to determine the user's carbon dioxide levels and may be used, for example, to modify the smoking cessation program.

[0052]

[0107] In some examples, the delivery device 109 also optionally includes a blood oxygen sensor 119 coupled to the controller circuit 130 and providing a signal to the controller circuit 130 indicative of the amount of oxygen in the blood. In one example, the blood oxygen sensor 119 can be a pulse oximetry sensor. In some examples, the blood oxygen sensor 119 can be incorporated into the fingerprint sensor 116. In some embodiments, the blood oxygen sensor 119 can be separate from the fingerprint sensor 116.

[0053]

[0108] The delivery device 109 may also include a pod ID chip interface 465, which may be located near the cavity 140 that receives the pod 150. The pod 150 configured for use with the delivery device 109 may include a pod ID chip 163. In some embodiments, the pod ID chip 163 may be located in a portion of the pod 150 such that when the pod 150 is placed in the delivery device 109, the pod ID chip interface 465 physically and / or electronically aligns with the pod ID chip 163 and information may be communicated from the pod ID chip 163 to the pod ID chip interface 465. The information may relate to one or more aspects of the configuration of the pod 150. In one example, the information may relate to one or more substances (e.g., type of substance, amount of substance remaining) in the aerosolizer of the pod 150. In another example, the information may be related to a pod ID that the delivery device 109 can compare to stored data to determine information related to the pod 150 (e.g., information related to the aerosolizer 152) that can be used to appropriately provide the desired aerosol mixture to the user.

[0054]

[0109] In this example, the delivery device 109 also includes a "rescue" button 116 that can be activated to provide the user with an additional (or "rescue") dose of one or more substances in the pod 150, such as, for example, an additional nicotine dose in a smoking cessation program. When the rescue button 116 is used, the controller circuit 130 stores information related to its use (e.g., date / time information for each use). The rescue button usage information can be used by the delivery system to modify the smoking cessation program. In some examples, the rescue button usage information is communicated by the delivery device 109 to the user device 15 and / or the server 25 and used to track the user's progress in the smoking cessation program and / or to dynamically modify the smoking cessation program as a result of the user needing a rescue dose. Based on the activation of the rescue button 116, the changes made to the smoking cessation program can be communicated from the server system 25 to the user device 15 and then from the user device 15 to the delivery device 109. The delivery device 109 may include one or more other functions, including an antenna 120, and communication circuitry implemented within the controller 130 or in a separate hardware component in communication with the controller 130, thereby enabling the delivery device 109 to communicate directly or indirectly over a network with a user device 15 or another computing device. Certain functions of the controller circuitry 130, or components of the delivery device 109 in communication with the controller circuitry 130, are further illustrated in Figures 4 and 5.

[0055]

[0110] 5, the controller circuit 130 includes one or more hardware processors 504 in communication with at least one non-transitory memory component 506, 508 that includes executable instructions that configure the one or more hardware processors 504 to execute a treatment program. The delivery device 109 includes aerosolizer drivers 110a-c that correspond to each of the aerosolizers 161 in the pod 150. The controller circuit 130 is connected to the aerosolizer drivers 110a-c and controls the aerosolizer drivers 110a-c to operate the respective aerosolizers 161a-c to generate aerosol such that a desired aerosol mixture reduced by the aerosolizer system is provided to the user as prescribed by the smoking cessation program. For example, the controller circuit 130 can control the aerosolizers 161a-c via the aerosolizer drivers 110a-c to generate a fixed amount of aerosol from the substance (a fluid mixture of nicotine) to be provided to the user in each aerosolizer 161a-c, such that the aerosol from each aerosolizer 161a-c is mixed in the aerosol mixing chamber 162 of the pod 150 to form a desired aerosol mixture.

[0056]

[0111] The controller circuit 130 can also independently control the aerosolizers 161a-c via the aerosolizer drivers 110a-c to affect the aerosol droplet size (ADS) in the aerosol generated by each of the aerosolizers 161a-c. The ADS of the aerosolized substance can determine where it is absorbed in the user. Smaller ADSs generally travel to and are absorbed in the lungs, while larger ADSs generally travel to and are absorbed in the mouth or throat. The controller circuit 130 can independently control the aerosolizers 161a-c via the aerosolizer drivers 110a-c to generate different sized ADSs based on the treatment program. For example, depending on what portion or stage of the treatment program the user is in (e.g., as shown in FIG. 10H). In some embodiments, the aerosol droplet diameter is 20 μm or less. In some embodiments, the aerosol droplet diameter is 10 μm or less. In some embodiments, the aerosol droplet diameter is 1 μm or less, or equal to 1 μm, 2 μm, 3 μm, 4 μm, 5 μm, 6 μm, 7 μm, 8 μm, 9 μm, 10 μm, 11 μm, 12 μm, 13 μm, 14 μm, 15 μm, 16 μm, 17 μm, 18 μm, 19 μm, or 20 μm, ±0.5 μm. In some embodiments, the aerosol droplet diameter is 1 μm or less (for at least a portion of the treatment program). In some embodiments, the aerosol droplet diameter is 10 μm or more (for at least a portion of the treatment program). In some embodiments, the aerosol droplet diameter for a portion of the treatment program can be 3 μm or less and for another portion of the treatment program, 8 μm or more. In some embodiments, the aerosol droplet diameter for a portion of the treatment program can be 1 μm or less and for another portion of the treatment program, 10 μm or more. In practical terms, when an aerosolizer is controlled to produce a particular aerosol droplet diameter, the aerosol droplet diameter can have a range of diameters, but will mostly be of a target diameter such that the deposition site of the aerosol is substantially the target deposition site (e.g., mouth, lungs, etc.).Thus, when referring to a particular aerosol diameter, this is understood to indicate that an effective amount of aerosol droplets of a particular diameter is generated. In one example, more than 30%, more than 40%, more than 50%, more than 60%, more than 70%, more than 80%, more than 90%, or more than 95% of the aerosol has a particular diameter. In another example, more than 50%, more than 60%, more than 70%, more than 80%, more than 90%, or more than 95% of the aerosol has a particular diameter. In one example, more than 70%, more than 80%, more than 90%, or more than 95% of the aerosol has a particular diameter.

[0057]

[0112] As shown in the example of FIG. 3C, the pod 150 includes three aerosolizers 161a-c. The electrical connections 111a-c are respectively connected to one of the aerosolizers 161a-c and can provide power and / or control information to the aerosolizers 161a-c. When the pod 150 is coupled to the delivery device 109, the electrical connections 111a-c are respectively coupled to the aerosolizer drivers 110a-c. In some embodiments including a thermal aerosolizer 161, control of the operation of the aerosolizers is achieved by varying the power provided to each heating element 152 of each aerosolizer 161 by the aerosolizer driver 110 via the electrical connections 111. The controller circuit 130 can individually control and power the multiple aerosolizer drivers 110 and correspondingly individually control each aerosolizer to generate a constant volume of aerosol and generate aerosol of a desired droplet size in accordance with a smoking cessation treatment program. Each thermal aerosolizer 161 can include a heating element 152, a container 159 configured to hold a substance (e.g., a fluid containing nicotine for a smoking cessation example), and a passageway 156. In one example of a fluid placed in the containers 159, a first container 159a illustratively contains a fluid containing monoprotonated nicotine. A second container 159b illustratively contains a fluid containing free radical nicotine. A third container illustratively contains a fluid containing another drug, a flavorant, or a non-nicotine placebo.

[0058]

[0113] In one example, the three containers 159a-c contain 2.5 mL of 5% flavor-based liquid and a mixture of propylene glycol (PG) and glycerin (G) in a PG:G ratio of 60:40. Additionally, container 159a contains 60 mg / mL synthetic nicotine and a pH adjuster to bring the pH to 4.0, thus ensuring that the species in this container 159a is monoprotonated nicotine. Container 159b contains 60 mg / mL synthetic nicotine at a pH of 10.0, thus ensuring that the nicotine species in this container 159b is free radical nicotine. 5% of the volume of container 159c is flavor-based and the remainder is a PG:G ratio of 60:40. Container 159c does not contain nicotine. In various embodiments, the exact ratio of PG:G, the amount of flavor system, the amount of pH adjuster, the final dose algorithm settings, and the aerosolization power settings can vary and can be based on the characteristics of the actual aerosolizer components used in the embodiments. Many factors can affect the aerosol delivered to the user, including but not limited to the micro-aerodynamics of droplet collision and condensation that change the aerosol exiting the mouthpiece. Information related to these factors can be determined during bench testing and used to calibrate the delivery device 109 based on the aerosolizer and pod design. Correspondingly, the algorithm can be adjusted to ensure that the aerosol mixture delivered to the user complies with the treatment program over the entire aerosol parameter range in a smoking cessation journey treatment program, such as the smoking cessation journey program shown in FIG. 7Q.

[0059]

[0114] Different aerosol droplet sizes are achieved by varying the power supplied to the surface electrodes. In principle, any porous material can be used with conductive electrodes, and previous generations have used cotton wicks surrounded by electrode coils. In the example of a thermal aerosolizer, each aerosolizer can use a ceramic wick and surface electrodes to allow for more precise aerosolization. As an example, the amount of aerosol generated by each aerosolizer 161 can be controlled by the amount of time that the aerosolizer is powered, causing the thermal component of the aerosolizer to reach a temperature sufficient to generate aerosols from the liquid in the aerosolizer's respective container. As an example, the size of the aerosol generated by each aerosolizer 161 can be controlled by the amount of power supplied to the aerosolizer, changing the temperature of the thermal component to correspondingly cause the generation of aerosols of different droplet sizes.

[0060]

[0115] Each passageway 156 includes a distal end 155 closest to the aerosolizer 159 and a proximal end 157 adjacent to the mixing chamber 162. The passageways 156 provide a flow path for the aerosols generated by the heating elements 152 to flow to the mixing chamber 162. The mixing chamber 162 includes a wall 166 that encloses a mixing space 167. In the mixing chamber 162, the individual aerosols generated by each of the aerosolizers 161a-c mix together to form an aerosol mixture that can be inhaled (ingested) by a user through an opening 164. In this example, power for the heating elements 152 is provided by the delivery device 109 via a connection 111. In some embodiments, the pod 150 includes one or more power sources that may provide power to the heating elements 152 or to other electrical components of the pod 150. The controller circuit 130 can control the aerosolizers 161 to produce an aerosol mixture of a certain total nicotine concentration by controlling the aerosol produced by each of the aerosolizers 161 according to a treatment program.

[0061]

[0116] The controller circuit 130 may be configured by treatment program information (e.g., algorithms) that the delivery device 109 has coded into its firmware and / or receives to drive the aerosolizers to generate the desired aerosol volume and droplet diameter size from each of the aerosolizers (e.g., three aerosolizers). The process begins with target delivery parameters for a puff on day n of the smoking cessation journey. These parameters inform a dose algorithm that determines how much liquid is needed from each of the three containers 159a-c. A mass conversion algorithm then determines how much energy must be delivered to each aerosolization electrode to achieve this, given the known microfluidic performance of the aerosolizer wick system implemented in the delivery device 109. One or more sensors (e.g., flow sensor 112) of the delivery device 109 determine the topography of the patient's puff, and from this data, an algorithm ensures that energy is provided to the electrodes during the puff to aerosolize the correct proportion of liquid in the containers 159a, 159b, and 159c and achieve the desired aerosol mixture. The aerosolization "driver" can incorporate data to adjust parameters (e.g., based on previously determined test data and / or based on one or more sensors in the delivery device, e.g., ambient temperature sensors) to account for condensation losses in the aerodynamic channel before the mouthpiece outlet, and aerosol droplet aggregation in this channel, thus ensuring that the aerosol droplet size at the mouthpiece outlet is what is expected. The pod 150 can optionally include a sensor 172 located on or near the exhaust port 164 that can sense characteristics of the user when the user is using the delivery system 100. Specifically, when the sensor 172 is in contact with, adjacent to, or near the user's mouth. In some examples, the sensor 172 is configured to sense characteristics of a user's saliva or a user's breath.The sensor 172 may include a hardware processor and other hardware components (e.g., sensors, transceivers, antennas, etc.) for sensing a characteristic and communicating information about the sensed characteristic to the delivery device 109 (for subsequent communication to the user device 15) or to the user device 15.

[0062]

[0117] The control of the aerosolizer 161 can be based on a smoking treatment program and on inputs received from one or more sensors (e.g., flow rate sensors). Nicotine in e-liquid can exist in two forms: free radical (meaning it does not contain a proton) and monoprotonated (meaning it has one proton, also called a "salt"). There is a correlation between the pH value of the liquid and the ratio of the two forms. A common way to control the pH level (and the ratio of free radicals) of the liquid is to use a certain amount of organic acid to adjust the pH. In some embodiments, the total nicotine concentration delivered in the aerosol can range from 0 to 58 mg / mL. This total concentration is determined by the monoprotonated nicotine concentration [NicH + ] and the free radical nicotine "concentration" [Nic]. Nicotine can also exist in a diprotonated state, but this state is never reached in tobacco aerosols because the conditions within the aerosol droplets are not sufficiently acidic.

[0063]

[0118] The free nicotine "ratio" ("FNR") can be calculated as follows: FNR = [Nic] / ([Nic]+[NicH + ]) FNR = 1 / (1+10 -pH / K a ) Here, K a isNicH +is the acidity constant of nicotine, which is 8.01. Thus, given a target FNR, the controller circuit 130 (e.g., firmware in the hardware processor of the controller circuit 130) can determine the required pH, and the microfluidics will mix a high pH solution with a low pH solution (containing the exact same total nicotine concentration) to achieve the target pH, thereby causing the FNR to be the value required by the treatment program.

[0064]

[0119] One embodiment of a portable charging case 165 is shown in FIG. 3D. The delivery device 109 can be stored and charged within the portable charging case 165. In this embodiment, the case 165 includes a display 166 for the user to observe both statistics and settings to which the system has been configured. The case 165 can house and be powered by a rechargeable power source, e.g., a battery 168, accessible via a charging port 169 disposed on the case 165, which is configured to receive a mating plug connector for charging the battery 168. The delivery device 109 can be stored in a cavity within the case 165 when not in use. In some implementations, the delivery device's power source 114 can be charged from the battery 168 via a wired or wireless connection.

[0065]

[0120] FIG. 4 is a schematic diagram of an example of a circuit 113 that may be used in a delivery device, such as the delivery device 109 shown in FIG. 1 and FIG. 3A. As shown in FIG. 4, communication lines may connect the controller circuit 130 and other components of the delivery device to form the circuit 113. The controller circuit 130 may include one or more hardware processors (e.g., multiple hardware processors 504 in FIG. 5). Airflow occurs when a user inhales air through the delivery device. In this schematic, the airflow is generally from left to right such that the inhalation of air is sensed by the flow sensor 112 and received by the aerosolizer 161. The aerosolizer 161 creates an aerosol in the airflow, which (in some embodiments) then passes through sensors (e.g., temperature sensor 158 and / or density sensor 160), enters a mixing chamber, and exits the pod to the user's mouth. FIG. 4 shows many of the components shown in FIGS. 3A-3C, as well as some additional components. For example, in this embodiment, the flash memory 410 is in communication with the controller circuit 130. The controller circuit 130 may include a transceiver or other communication circuit coupled to the antenna 120 that allows the delivery device 109 to communicate with a smartphone, another device, or a network. As shown in FIG. 4, the circuit 113 may also include a pod ID chip interface 465. In such an embodiment, when the pod 150 is coupled to the delivery device 109, the pod ID chip interface 465 communicates with the pod ID chip 163 of the pod 150 to communicate information between the pod and the delivery device. The circuit 113 may also include a case data interface 425 that communicates with the controller circuit 130, and a case charging interface 430 that communicates with a battery manager 420 that manages power provided to the controller circuit 130 from the power source (e.g., battery) 114, for example, to manage charging of the battery 114 by the case or another power source.

[0066]

[0121] 5 is an example of a computer system 500 that may be used to perform the functions described herein for a treatment system, e.g., a delivery device, a user device, and / or a server system. In some embodiments, the computer system 500 may be characterized as including all electrical and electronic components of a treatment system. In some embodiments, the computer system 500 may be characterized as being the system illustrated in FIG. 1. In this particular example, the computer system 500 is broadly described as including a controller circuit 130 within the delivery device 109, with other components in communication with the controller circuit 130. However, this description is not intended to limit the computer system 500 to be construed as referring only to the controller circuit 130 and its components.

[0067]

[0122] The controller circuit 130 may include a bus 502 or other communication mechanism for communicating information between components of the smoke-free system, and a hardware processor or processors 504 coupled with the bus 502 for processing information. The hardware processor 504 may be, for example, one or more general-purpose microprocessors. The hardware processor 504 includes non-transitory memory 505. In some examples, the functionality of the components illustrated in the controller circuit 130 may be implemented in a single chip (e.g., an ASIC), and the classification policy is stored in a memory and / or circuit, for example, the memory 505.

[0068]

[0123] The computer system 500 also includes a main memory 506, such as a random access memory (RAM), cache, and / or other dynamic storage device, coupled to the bus 502 for storing information and instructions executed by the processor 504. The main memory 506 may also be used to store temporary variables or other intermediate information during execution of instructions executed by the processor 504. Such instructions, when stored on a storage medium accessible to the processor 504, including on memory 505 integrated on the processor chip, make the computer system 500 a special-purpose machine customized to perform the operations specified in the instructions of the smoking or smoking cessation program. The computer system 500 further includes a read-only memory (ROM) 508 or other static storage device coupled to the bus 502 for storing static information and instructions for the processor 504. A storage device 510, such as a magnetic disk, optical disk, or USB thumb drive (flash drive), is provided and coupled to the bus 502 for storing information and instructions.

[0069]

[0124] Computer system 500 may be coupled via bus 502 to a display 512, which may include a touch screen, such as an LCD or liquid crystal display, for displaying information to a network operator. An input device 514, including alphanumeric and other keys, is coupled to bus 502 for communicating information and command selections to processor 504. Another type of user input device is a cursor control 516, such as a mouse, trackball, or cursor direction keys, which the network operator uses to communicate directional information and command selections to processor 504 as well as to control cursor movement on display 512.

[0070]

[0125] Computer system 500 may include a user interface module for implementing a GUI, which may be stored in a mass storage device as computer executable program instructions executed by a computing device. Computer system 500 may implement the techniques described herein using customized hardwired logic, one or more ASICs or FPGAs, firmware and / or program logic that combine with the computer system to make or program computer system 500 into a special purpose machine, as described below. According to one embodiment, the techniques herein are performed by computer system 500 in response to processor 504 executing one or more sequences of one or more computer readable program instructions contained in main memory 506. Such instructions may be read into main memory 506 from another storage medium, such as storage device 510. Execution of the sequences of instructions contained in main memory 506 causes processor 504 to perform the process steps described herein. In alternative embodiments, hardwired circuitry may be used in place of or in combination with software instructions.

[0071]

[0126] Various forms of computer readable storage media may be involved in carrying one or more sequences of one or more computer readable program instructions to the processor 504 for execution. The instructions may be for operating a smoking cessation program using the user device 15 and / or the delivery system 100. For example, the instructions may initially be carried on a magnetic disk or solid state drive of a remote computer (e.g., server 25). The remote computer may load the instructions into its dynamic memory and transmit the instructions over a network. The transceiver of the computer system 500 places the data on the bus 502. The bus 502 carries the data to the main memory 506, from which the processor 504 retrieves and executes the instructions. The instructions received by the main memory 506 may optionally be stored on storage device 510 either before or after execution by the processor 504.

[0072]

[0127] Computer system 500 also includes a communications interface 518 coupled to bus 502. Communications interface 518 provides a two-way data communication coupling to a network link 520 that is connected to network 20. For example, communications interface 518 may be an integrated services digital network (ISDN) card, a cable modem, a satellite modem, or a modem to provide a data communication connection to a corresponding type of telephone line. As another example, communications interface 518 may be a local area network (LAN) card to provide a data communication connection to a corresponding LAN (or a WAN component in communication with the WAN). A wireless link may also be implemented. In any such implementation, communications interface 518 sends and receives electrical, electromagnetic or optical signals that carry digital data streams representing various types of information.

[0073]

[0128] A network link typically provides data communication through one or more networks to other data devices. For example, a network link may provide a connection by smartphone 15 to server 25 through network 20. Computer system 500 may send messages and receive data, including program code, through the network(s), network link and communication interface 518. In the Internet example, server 25 might send requested code for an application program through network 20 and communication interface 518. The received code may be executed by processor 504 upon receipt and / or stored in storage device 510, or other non-volatile storage, for later execution.

[0074]

[0129] In various embodiments, certain functionality may be accessible by the user through a web-based viewer (such as a web browser) or other suitable software program on the user device 15 or other computer. In such embodiments, the user interface may be generated by the server system 25 and transmitted to the user device 15. Alternatively, the data necessary to generate the user interface (e.g., user interface data) may be downloaded to the user device 15 as a separate app. The user may then interact with the user interface on the user device 15 through the app to view information related to the treatment program and interact with the treatment program.

[0075]

[0130] FIG. 6A illustrates an example of high-level data flow logic for a smoking cessation system. A new user 30 seeking to quit smoking can use a smoking cessation application 608 to perform at least a portion of the onboarding. The smoking cessation application 608 can be implemented on a user device (e.g., a smartphone, a mobile computer, a desktop computer, a dedicated computer at a physician's facility, or other suitable computer resource), such as the user device 15 (FIG. 1). The smoking cessation application 608 can include functionality that executes partially on the portable computer and partially on a server system. As part of the onboarding, the user 30 can be prompted to enter a profile 603 into the smoking cessation application 608. The profile 603 can include characteristics related to nicotine withdrawal. This can include age, sex, height, weight, smoking history including number of cigarettes smoked per day, time of day of use, biological cofactors, psychosocial cofactors, clinical cofactors, and other relevant characteristics. For example, the application 608 can request the number of cigarettes smoked per day, the brand of cigarettes, and whether the user 30 smokes electronic cigarettes (e-cigarettes). If the user 30 indicates via the interface that they will be smoking an electronic cigarette (e-cigarette), the application 608 may further request the user to provide the time of use of each cartridge and the nicotine dose per cartridge.

[0076]

[0131] Other information may also be input, including objective medical information determined from one or more tests of the user, such as the user's nicotine metabolic rate (NMR). Once the data is input, the application 608 may determine a treatment program / quit schedule 607 based on the user's individual profile 603 and other provided information. The schedule may then be output 606 to the user 30 on an app on the user device 15. The output 606 may be in the form of one or more charts, tables, and / or other information related to the treatment program. The information may include an indication of the amount of cigarettes or puffs recommended to the user 30 at a particular time period during the program. This may include a recommended number of cigarettes per day, week, or month with the option to display different time periods. Additionally, the user 30 may be given different options to select a pace of withdrawal from different recommended paces, including a pace that will result in a faster withdrawal from nicotine use.

[0077]

[0132] The user 30 may seek the help of an external advisor 35, such as a doctor, to measure or calculate the information required for the profile 603. The advisor 35 may also play a role in monitoring the progress 605 of the smoking cessation application 608, which may lead to changes in the program being used.

[0078]

[0133] The smoking cessation system 100 receives data from the smoking cessation application 608 to deliver the intended dose to the user 30. The smoking cessation system 100 also stores puff data 601 in memory 506, which may include puff duration, puff interval, and / or puff volume, for transmission back to the smoking cessation application 608 and the treatment program on the server system 25 via the controller circuit 130. This puff data 601 can be monitored by the user 30 or advisor 35, and the treatment program itself, to determine adjustments to the smoking cessation schedule 607.

[0079]

[0134] FIG. 6B is a flow chart illustrating an example of a smoking cessation process 600 according to one embodiment. In one example, the smoking cessation process 600 is for assisting a user to quit smoking. In another example, the smoking cessation process 600 is for assisting a user to quit vaping. In another example, the smoking cessation process 600 is for assisting a user to quit addictive behavior. In block 605, the process 600 operates at least a portion of a treatment program on a handheld delivery system. In one example, the handheld delivery system is the delivery system 100 shown in FIG. 3A. In block 610, the process 600 independently controls the aerosols generated by each of three or more aerosolizers in the delivery system based on the treatment program to form an aerosol mixture. In another example, the process 600 can independently control the aerosols generated by each of two aerosolizers in the delivery system based on the treatment program to form an aerosol mixture. The aerosol mixture can then be inhaled by a user.

[0080]

[0135] 6C is a flow chart illustrating another example of a treatment process 700, for example, for treating smoking or vaping addiction. In block 705, the process 700 provides a handheld drug delivery system, the delivery system having an aerosolizer system with three aerosolizers, each containing a different substance. In one example, the aerosolizer system is similar to the aerosolizer system of the pod 150 shown in FIG. 3C, which has three aerosolizers. While this disclosure generally refers to pods having three aerosolizers, or more than two aerosolizers, in other embodiments, the pod can have two aerosolizers and provide an aerosol mixture from substances contained in the two aerosolizers, similar to those described herein for the three aerosolizer embodiment.

[0081]

[0136] In block 710, process 700 controls the aerosol generated by each of the three or more aerosolizers to form an aerosol mixture in an aerosol mixing chamber of the smoke-free system, the aerosol mixture being formed based on the treatment program and based on information from one or more sensors on the handheld delivery system, such as one or more of the sensors illustrated in FIG.

[0082]

[0137] When the delivery system operates to provide a smoking cessation program to a user, the controller circuit executes smoking cessation program instructions that cause the multiple aerosolizer drivers to provide signals. The signals provided to the multiple aerosolizer drivers can be based on the treatment program instructions and, optionally, information that the controller circuit receives from one or more sensors of the delivery system, such as, but not limited to, any one or more of a flow rate sensor, an aerosol density sensor, and an aerosol temperature sensor, an ambient temperature sensor, an ambient pressure sensor, a blood oxygen sensor, and / or a carbon dioxide sensor. The treatment program instructions can include instructions and information stored in the delivery system when the delivery system is manufactured or configured, and / or instructions and information received by the delivery system from a user device 15, a server system, and / or another computer system.

[0083]

[0138] In embodiments disclosed herein, the aerosolizer system can include one, two, three, or more aerosolizers. In some embodiments, pods with different numbers of aerosolizers may be used for different parts of a smoking cessation program, and the (same) delivery device (e.g., delivery device 109) can be configured to work with pods with one, two, three, or more aerosolizers.

[0084]

[0139] For a delivery device used with a pod having multiple aerosolizers, in embodiments disclosed herein, the controller circuitry can provide signals to multiple aerosolizer drivers 110 to cause the multiple aerosolizers in the pod to generate an aerosol mixture having various amounts (e.g., percentages) of the substance in the pod based on a treatment program. For example, for a pod having three aerosolizers for three substances in the pod (one aerosolizer for each substance), the delivery device may provide signals to the three aerosolizer drivers such that the first driver drives the first aerosolizer, and ... Generate 0, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, 60, 61, 62, 63, 64, 65, 66, 67, 68, 69, 70, 71, 72, 73, 74, 75, 76, 77, 78, 79, 80, 81, 82, 83, 84, 85, 86, 87, 88, 89, 90, 91, 92, 93, 94, 95, 96, 97, 98, 99, or 100% (± 0.5%) aerosol mixture (the "resulting" aerosol mixture).The delivery device 109 (e.g., the controller circuit 130) provides signals to the three aerosolizer drivers such that the second driver drives the second aerosolizer to: 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, Generate 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, 60, 61, 62, 63, 64, 65, 66, 67, 68, 69, 70, 71, 72, 73, 74, 75, 76, 77, 78, 79, 80, 81, 82, 83, 84, 85, 86, 87, 88, 89, 90, 91, 92, 93, 94, 95, 96, 97, 98, 99, or 100% (± 0.5%) aerosol mixture (the "resulting" aerosol mixture). The delivery device 109 provides signals to the three aerosolizer drivers such that the third driver drives the third aerosolizer to provide the following: 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, 60, 61, 62, 63, 64, 65, 66, 67, 68, 69, 70, 71, 72, 73, 74, 75, 76, 77, 78, 79, 80, 81, 82, 83, 84, 85, 86, 87, 88, 89, 90, 91, 92, 93, 94, 95, 96, 97, 98, 99, or 100% (±0.5%) of the aerosol mixture (the "resulting" aerosol mixture). Similarly, in other embodiments having two aerosolizers or four or more aerosolizers, the delivery device can provide a signal to each aerosolizer driver, and each aerosolizer will correspondingly generate a resulting aerosol mixture between 0 and 100%.

[0085]

[0140] Additionally, the delivery device 109 (e.g., the controller circuit 130) can provide signals to the aerosolizer driver 110 to generate aerosols from different substances with different droplet sizes according to a treatment program. For example, the controller circuit 130 can provide signals to three aerosolizer drivers such that the signals drive three corresponding aerosolizers in a pod to generate aerosols having the same droplet size, or two or more different droplet sizes. In some embodiments, the aerosol droplet diameter is less than 1 μm or equal to ±0.5 μm of 1 μm, 2 μm, 3 μm, 4 μm, 5 μm, 6 μm, 7 μm, 8 μm, 9 μm, 10 μm, 11 μm, 12 μm, 13 μm, 14 μm, 15 μm, 16 μm, 17 μm, 18 μm, 19 μm, or 20 μm.

[0086]

[0141] Referring to examples of smoking cessation treatment programs developed to wean individuals off smoking or vaping, certain co-factors can be evaluated to create a smoking cessation program or treatment plan for a particular user, for example similar to the program shown in FIG. 7Q. FIG. 7A, FIG. 7B-1, FIG. 7B-2, and FIG. 7C show how behavioral change and precision medicine can affect the personalization domain that influences how the body processes nicotine. FIG. 7D, 7E, 7F, 7G, 7H, and 7I show the D-ADME that can determine how biological influences factor into the smoking persona. 2 The model shows how psychosocial co-factors can result in a user being forced to start smoking. Finally, Figures 7K, 7L, 7M, 7N, 7O, and 7P show how personas and personalization parameters can be used to map cessation solution variables.

[0087]

[0142] Treatment programs or smoking cessation can be created by a combination of biological, psychosocial, and clinical cofactors, which can be called smoking personas. This information can be input as parameters used to control the delivery device to change the concentration of the substance contained in the aerosolizer system at different times during the program schedule for a particular person. Biological cofactors are the individual's unique adaptation to nicotine, which is related to the individual's neurobiological phenotype. Psychosocial cofactors can be the individual's unique conditioned inducement to smoking, in terms of personal and environmental conditions. Clinical cofactors are severe psychological or cognitive challenges.

[0088]

[0143] Additional parameter considerations may include smoking facilitators and smoking cessation inhibitors. The management of smoking facilitators and smoking cessation inhibitors to wean an individual from smoking or vaping may be a combination of using delivery / device systems, using behavioral software, and medical consultation. The following table shows possible smoking facilitators or smoking cessation inhibitors, a description of each, and how smoking cessation systems, software, or advisors / medical consultations can assist. In this embodiment and generally herein, smoking cessation delivery devices and smoking cessation treatment programs may be referred to as "no more" devices / programs. JPEG2024528647000002.jpg199156JPEG2024528647000003.jpg233154JPEG2024528647000004.jpg23415 5JPEG2024528647000005.jpg231155JPEG2024528647000006.jpg233155JPEG2024528647000007.jpg52152

[0089]

[0144] In the above table, "PHQ" refers to the common mental disorder diagnostic instrument of the PRIM-MD, a self-report version of the commonly known Patient Health Questionnaire. PHQ-9 is the depression module. PHQ-2 asks about the frequency of depressed mood and anhedonia over a period of time (e.g., 2 weeks) and includes the first two items of PHQ-9. "GAD" refers to the commonly known score for generalized anxiety disorder.

[0090]

[0145] FIG. 7A illustrates pharmacological dose-related personalization data and behavior change as two intersecting areas of smoking cessation program personalization.

[0091]

[0146] Figures 7B-1 and 7B-2 are two-part tables showing the personalization parameters that affect how the body processes nicotine and how each may be quantified. Based on priority, the personalization parameters can be divided into primary, secondary, and tertiary / quaternary parameters.

[0092]

[0147] FIG. 7C is a diagram illustrating examples of primary, secondary, and other focused personalization areas utilized by the smoking cessation system previously illustrated in FIGS. 7A, 7B-1, and 7B-2.

[0093]

[0148] Figure 7D shows the D-ADME 2 Figure 7D illustrates the basic model components of nicotine and how nicotine is deposited in the body. As this diagram shows, nicotine can be absorbed, distributed, and metabolized based on an individual's genomics, personal, and environmental factors. The by-products resulting from this processing are removed and excreted from the body. Figure 7D illustrates that biological co-factors help define smoking personas.

[0094]

[0149] Figure 7E is an example of how to determine how an individual metabolizes nicotine by calculating nicotine input and measuring nicotine output, often referred to as the Nicotine Metabolic Rate (NMR). In some embodiments, the NMR can be calculated for an individual to reveal how quickly the individual processes nicotine biochemically. This information can be applied to form an individual's persona and as input parameters for smoking cessation programs.

[0095]

[0150] Figure 7F is the same diagram as Figure 7D, showing how nicotine is deposited in the body. In addition, this diagram identifies four main personalization parameters that can be configured for use in a smoking cessation program. In some embodiments, the four parameters include the dose of nicotine that a user receives when using a smoking cessation device, where the nicotine is deposited, how quickly the nicotine is absorbed, and how quickly the nicotine is metabolized.

[0096]

[0151] Figure 7G includes the four main personalization parameters as shown in Figure 7F, but in this embodiment, shows three important variables of the smoking cessation liquid and aerosol that may affect the personalization parameters. In some embodiments, the three important variables include nicotine concentration, aerosol droplet size, and free nicotine ratio.

[0097]

[0152] FIG. 7H is an exemplary embodiment of a detailed cascade D-2 ADME personalization model showing the central and peripheral compartments.

[0098]

[0153] Figure 7I uses the same cascaded personalization model as Figure 7H to show how adding personalized user persona information and smoking cessation device settings affect NMR.

[0099]

[0154] Figure 7J illustrates how psychosocial co-factors affect nicotine deposition in the body when a user is compelled to smoke. As mentioned above, psychosocial factors include incentives, attachments, substances, and pathology.

[0100]

[0155] 7K illustrates how personalization parameters and clustered persona characteristics are used to map the magnitude and range of associated smoking cessation solution parameters. Biological and psychosocial persona parameters can be crossed to generate different levels of smoking cessation solution required for a smoking cessation program.

[0101]

[0156] Figure 7L shows the diagram of Figure 7K with low, medium, or high nicotine strength depending on the persona level. In one embodiment, weak biological persona parameters and mild psychosocial persona parameters result in a low concentrated nicotine strength for the smoking cessation program. In another embodiment, a combination of strong biological persona parameters and strong psychosocial persona parameters results in a high recommended nicotine strength.

[0102]

[0157] FIG. 7M adds to FIG. 7L by showing the bioavailability of nicotine between personas.

[0103]

[0158] Figure 7N adds to Figure 7M by showing how aerosol droplet size maps to persona profiles and metabolic rates. In one embodiment, larger aerosol droplets may result in higher concentrations upon lung deposition. In another embodiment, smaller aerosol droplets may result in lower concentrations upon oral deposition.

[0104]

[0159] Figure 7O adds to Figure 7N how smoking frequency and puff topology can add variables unique to the smoking cessation liquid for the user. In one embodiment, higher nicotine concentrations may be provided to users who are middle-aged, heavy smokers, typically metabolized, have severe withdrawal symptoms, increased smoking urges, increased sensory enjoyment, heavy alcohol use, and increased smoking addiction.

[0105]

[0160] Figure 7P illustrates how the users of Figure 7O can benefit from a personalized smoking cessation program based on their quitting initiation time, age, behavioral information regarding triggers, stress, anxiety, depression, alcohol consumption, and social cue responses. In one embodiment, the smoking cessation program can create personalized tapering paths, tapering rates, and program durations for different users.

[0106]

[0161] 7Q illustrates an example five-step process that can be implemented for a treatment program designed for smoking cessation. In this example, the program includes onboarding 801, tobacco tapering 802, nicotine tapering 803, placebo use 804, and software support 805 stages.

[0107]

[0162] The purpose of the onboarding phase 801 is to register and enroll the user and to pre-configure the device. This onboarding phase 801 may begin with an appointment with the prescribing physician and end with the NMR analysis results. Some steps for dose calculation include obtaining a saliva sample for analytical NMR determination, identifying likely consumable categories based on persona, creating a preliminary definition of initial values ​​for smoking cessation liquids based on persona, verifying age, interviewing with a physician to assess menopausal status, creating a preliminary definition of a tapering path and tapering deceleration based on co-morbidities, medications, lifestyle factors, age and persona, and configuring NMR inputs upon receipt of test results.

[0108]

[0163] Some psychosocial and clinical activities included in the onboarding phase 801 include: defining an aspirational definition of the quitting period, qualitative determination of persona elements (e.g., name, gender, age, occupation, location, etc.), an outline of the behavioral program for subsequent phases (education, trigger identification, urge management, stress management, quitting tapering, quitting treatment), an outline of social support, an outline of professional support, and a physician interview to identify the presence / susceptibility of additional behavioral elements (uncontrollable severe stress, generalized anxiety disorder, depression, bipolar disorder, post-traumatic stress disorder, existing traumatic brain injury, schizophrenia) and set a date for profiling.

[0109]

[0164] Other activities in the onboarding phase 801 may include various registration activities, joining a consumable delivery service, user specification of flavor systems (tobacco, non-menthol), or enlisting motivated onboarded smoking cessation system users, once they have successfully quit smoking, to help two other people quit smoking under the auspices of a "pay it forward" strategy. The duration of onboarding varies depending on various factors, but typically takes about 5-10 business days.

[0110]

[0165] In this example, the second phase of the treatment program is a tobacco tapering phase 802, which may include profiling and product familiarization. The purpose of this tobacco tapering phase 802 is to finalize personalization, define starting delivery parameters, and / or set a quit date. This phase can begin immediately after the NMR results are configured and end with a successful quit date.

[0111]

[0166] Some steps for dose calculation may include setting initial delivery parameters to match tobacco experience based on persona data. In one example, for light smokers with low NMR and less than 1 pack / day, the initial nicotine concentration r=3 wt% and the initial release fraction αfb=0.03. In another example, for heavy smokers with higher NMR and more than 1 pack / day, the initial nicotine concentration r=5 wt% and the initial release fraction αfb=0.07. In yet another example, the initial aerosol droplet size δ≦1.0 μm.

[0112]

[0167] Another dose calculation activity could be to set the initial PRN / rescue concentrations higher than the standard but with the same αfb and δ according to the persona, e.g., nicotine concentration r=5 wt% for light smokers and nicotine concentration r=7 wt% for heavy smokers.

[0113]

[0168] Other dose calculation activities may include 5-day and 10-day parameter range assessments (including global ramping around the initial settings and settings of PRN doses of nicotine concentration r and initial release rate α with constant δ to establish final parameter values ​​for the purpose of a satisfactory and comfortable daily dose or a maximum satisfactory and acceptable PRN dose), recording of user puff topology to enable dose calculation and finalize delivery parameters and update program configuration, or confirmation or adjustment of smoking cessation tapering periods for subsequent steps.

[0114]

[0169] Psychosocial and clinical activities in the tobacco tapering phase 802 may include defining the quit date (QSD) (estimated 2-4 weeks from the start of the dual use phase), including a learning / adaptation period (5-10 days) to the smoking cessation program using the initial delivery parameter values ​​from the onboarding phase 801, or a dual use period (14-21 days) with tobacco tapering (steps below). ·Tobacco Reduction: Techniques for tapering: 1) ad lib; 2) reduction in frequency (hourly to 16 times / day, then every 2 hours to 8 times / day); 3) schedule smoking (upon waking, after meals, and in the evening, 1 to 5 times / day). Using the technique of your choice, halve the number of cigarettes you smoke to 10 cigarettes / day for the first 50% of your time to the QSD, then halve it again to 5 cigarettes / day for 75% of your time to the QSD, and then reduce to zero cigarettes once you have reached the QSD. ·Replace reduced tobacco use with "No More" use.

[0115]

[0170] Other psychosocial activities could include progressive behavioral training (education about health risks such as lung cancer, chronic obstructive pulmonary disease (COPD), and heart disease; identification and recording of temporal, associative, emotional, spatial, and alcohol triggers; and awareness training for stress management), a telephone call with a professional counselor 2 to 3 days before the quit date to increase the likelihood of behavioral change, or a telephone call with a former smoking cessation program user as a smoking cessation advisor.

[0116]

[0171] Other activities in the tobacco tapering phase 802 may include smoking cessation program training videos to cover changes in slowing down and increasing depth of inhalation, how the smoking cessation program differs from smoking, light and button functions, battery recharging, replacement of consumables, or general use recommendations for the learning period. Other activities may include setting up a schedule for refilling consumables. One activity may cover steps to take if the quit attempt is unsuccessful, i.e., does not proceed to the nicotine tapering phase 803, reassess and determine what went wrong and develop a new strategy based on what went wrong (based on stress management behavioral therapy if stress, strengthening social support elements if motivational / social causes, or reviewing product information / videos if technical causes), engaging medical support if they simply are not engaged, setting a new quit date in 2-4 weeks and making plans to prepare for it, or resetting the tapering and starting the tobacco tapering phase 802 again. The duration of the tobacco tapering phase 802 may vary based on many factors, but it may typically be in the range of about 7-15 weeks.

[0117]

[0172] In this example, the third phase of the treatment program for smoking cessation may be a nicotine tapering phase 803. This phase may include the goal of ceasing nicotine use. This phase may begin after the successful quit date and end when the quit tapering reaches the final dose level of nicotine.

[0118]

[0173] In some embodiments, steps for dose calculation may include not changing previously established PRN / rescue settings, beginning abstinence tapering from previously defined starting conditions for nicotine concentration, release fraction, and aerosol droplet size, beginning tapering two weeks after beginning the nicotine tapering phase 803, applying tapering variables and rates according to previously defined tapering parameters, monitoring PRN / rescue usage and adjusting tapering variables if tapering is determined to be too rapid or of insufficient duration. Regular use of high PRN >10x for consecutive days (3-4 days): Indicates that standard dose is insufficient. Reassess tapering and consider adjustment. - Consult with the user regarding an increase. Retest to determine regular dose threshold and reset tapering to this new dose to slow down the rate of tapering. The nicotine concentration of the final dose is likely to be ρ<1% by weight: Increase the aerosol to δ≧2.0μm, decreasing the absorption rate and peak. · The free rate is increased to 0.01≦αfb≦0.03 to give it a smooth taste.

[0119]

[0174] In some embodiments, psychosocial activities may include defining a taper date to reach the final dose of nicotine and an end date for the nicotine taper phase 803 (a clearly defined date such that the total duration of use in the smoking cessation program does not exceed 26 weeks). Other psychosocial activities may include recording clearly defined dates and times, monitoring the use of PRN / rescue doses, assisting with recognition of stressful events and smoking cessation management, etc. Deviations (use of 1-2 cigarettes / day in addition to smoking cessation program): · Counseling, evaluation and encouragement for restarting. -Consider tapering adjustments. If you relapse (return to full smoking at the level at which you began tapering phase 802): -Restart from the beginning of the tobacco tapering phase 802. -Consider tapering adjustments. Repeated taper resets, relapses, and failures during the nicotine taper phase 803: · Reassure them that smoking cessation programs are not to be viewed as a recreational product that can be used forever. Allow for 2-3 decay resets in highly dependent users. Allow for an extension of the total time for quitting treatment, provided medical consultation is provided. During the tapering "tail" phase, where the final dose is very low, this phase is expected to last 2-6 weeks: No more support at this stage. · PRN / rescue doses are still available. At final dose, evaluate user and consider long-term use unless total duration of use exceeds 26 weeks.

[0120]

[0175] Other activities during the nicotine tapering phase may include preparations to transition out of use of a smoking cessation program and to provide potential support to others in an online community.

[0121]

[0176] In this example, the fourth phase of the treatment program may be a placebo use phase 804, which includes the goal of no nicotine intake and no relapse for the user. This phase may begin after the successful quit date or 26 weeks, whichever comes first. This phase may end in the absence of grief or withdrawal symptoms. Psychosocial and clinical activities may include defining the post-quit period, monitoring to ensure the absence of physical withdrawal symptoms, supporting potential grief management, ongoing behavioral change support (active recognition of stressful events or stress management without relying on smoking), or recording of triggers and cues (uploading for monitoring and behavioral support).

[0122]

[0177] Other activities in the placebo use phase 804 may include video training for a possible role as a coach and support resource in the online smoking cessation program community.

[0123]

[0178] In this example, the fifth phase of the smoking cessation program is the support phase 805, which may include the goal of ceasing use of the smoking cessation program. This phase may end at the user's discretion. Dosage activities for this phase may include disabling use of the smoking cessation system device unless the intended use transitions from "quit smoking" to "exposure reduction & risk reduction." One of the psychosocial activities may include community strengthening support. Other activities may include active participation in an online support "pay it forward" community, or transitioning the intended use to exposure reduction and risk reduction in certain extreme cases.

[0124]

[0179] FIG. 8A is a block diagram further illustrating certain aspects of an onboarding process for a treatment program for smoking cessation. The onboarding process for a treatment program can be performed by the user device 15 and the server system 25 to register the user, including providing questions to the user and receiving user-specific information / answers to the questions. One or more tests can be administered to the user, and information from the laboratory administering the tests (e.g., NMR determination) can be received by the treatment program, for example, on the server system 25. Based on the information provided by the user and any test information, the treatment program can determine a smoking persona profile, a personal profile, and a smoking cessation treatment program for the user. The treatment program can include various aspects including determining one or more of the number of steps required to control the delivery device, the planned duration of each of the steps, initial parameters, and the expected nicotine consumption of the program and portions of the program.

[0125]

[0180] FIG. 8B illustrates aspects of data communication between a server system, a user device (mobile platform), and a delivery system that execute processes for medical treatment. For example, the server system 25, the user device 15, and the delivery system 100 shown in FIG. 1 execute processes for a smoking cessation program. The server system 25, the user device 15, the delivery system 100, and the sensor 17(s) may all include hardware processors and non-transitory computer-readable media, which, when executed, include instructions that configure the respective hardware processors to execute processes for a health treatment program. These processes include hardware components (e.g., transceivers, antennas, etc.) that communicate one-way or two-way between the sensor 17(s), the delivery system 100, the user device 15, and the server system 25 to control the delivery system 100 to provide a substance to the user according to the treatment program executed on the server system 25 and the user device 15.

[0126]

[0181] As described with reference to Figure 8A, during onboarding 801, user-specific registration information can be communicated from the user device 15 to the server system 25, and according to some embodiments, the treatment program can be based on that information. Figures 8C and 8D show examples of user interfaces 861-872 that can be displayed on the user device during the onboarding process. In this process, questions are presented to the user and inputs related to smoking habits and personal information are received from the user, and the inputs can be used by the user device and server system to tailor the treatment program (in this example, a smoking cessation program).

[0127]

[0182] Calibration and configuration information is also communicated from the server system 25 to the user device 15 and then to the delivery system 100 as part of the process of onboarding the user to the treatment program. FIG. 8E shows an example of a user interface displayed on the user device during the device calibration process, according to some embodiments. The user interface (U / I) 873 prompts the user to unlock the delivery device using a fingerprint sensor. If fingerprint information has not yet been received from the user, it can also be done at this stage. The U / I 874-877 personalize the user's puff information to calibrate the device for the particular user. Using the U / I, the process prompts the user to take multiple puffs using the delivery system, which monitors the puffs using a flow sensor. The U / I 876 receives input from the user regarding the strength of the aerosol mixture received during multiple puffs (e.g., 3 puffs). Multiple puffs can be used and the data averaged. This input can be used to change how the aerosolizer is driven to adjust the strength of the "dose" perceived by the user.

[0128]

[0183] As an example, the treatment program can be a smoking cessation treatment program as shown in FIG. 7Q. After onboarding, during phase 1 of the treatment program 850, program data is communicated from the server system 25 to the user device 15 and from the user device 15 to the delivery system 100. In one example, the program data can include information that the controller circuit 130 uses to drive the aerosolizers 161a-c to generate an aerosol mixture containing monoprotonated nicotine, free radical nicotine, and flavors and having a particular droplet size, e.g., droplets having a diameter of 1.0 μm or less, according to the treatment program. During phase 1 of the treatment program 850, usage data generated by the delivery system is communicated from the delivery device 100 to the user device 15 and then to the server system 25. The usage data can also include any information sensed by the delivery system 109 based on the user's use of the delivery system 100 during the treatment program. In one example, the usage data may include data related to the number of puffs, the duration of each puff, sensed data from the delivery system 109 (e.g., air flow in / through the delivery system (e.g., from a flow sensor), ambient temperature, ambient pressure, fingerprint matching data, pod information (e.g., from a pod ID chip), blood oxygen sensing information, and / or carbon dioxide sensing information, information sensed from the user's saliva, etc.). In some embodiments, the usage data may include information related to the amount of substance (e.g., liquid) in one or more containers of the pod 150. Also, in some embodiments, user data sensed by the sensor(s) 17 may be communicated from the sensor(s) 17 to the delivery system 100 or user device 15 and then to the server system 25 where it may be used to dynamically adjust a treatment program or monitor a patient's progress in a treatment program. The user data sensed by the sensor 17 may include information related to sensed user characteristics. For example, temperature, pH, sweat, blood sugar levels, blood nicotine levels, other characteristics of the user's blood, information from a pacemaker, and / or information associated with sensors implanted in the user.Information related to the use of the delivery system and the user's progress in the treatment program may be illustrated on the U / I of the user device. Figure 8F shows examples of user interfaces 878, 879, 880 that may be displayed on the user device during a treatment program, according to some embodiments.

[0129]

[0184] As shown in FIG. 8B, subsequent stages of the treatment program 851, 852,..., indicate additional stages of the treatment program, such as the tobacco taper 802, nicotine taper 803, and placebo taper 804 stages shown in FIG. 7Q. During the subsequent stages 851, 852,..., of the treatment program, additional program data associated with the particular stage is communicated from the server system 25 to the user device 15 and from the user device 15 to the delivery system 100, and usage data generated by the delivery system is communicated from the delivery device 100 to the user device 15 and then to the server system 25. During the subsequent stages of the treatment program 851, 852,..., the program data may include information that the controller circuit 130 uses to drive the aerosolizer 161a-c to generate an aerosol mixture comprising monoprotonated nicotine, free radical nicotine, and flavors and having droplets having a particular droplet diameter, e.g., between 1.0 μm or less and 10 μm or more, in accordance with the treatment program.

[0130]

[0185] Also, during these subsequent stages of the treatment program 851, 852, ..., usage data generated by the delivery system is communicated from the delivery device 100 to the user device 15 and then to the server system 25. The usage data may include any information sensed by the delivery system 109. In one example, the usage data may include data related to the number of puffs, the duration of each puff, sensed data from the delivery system 109 (e.g., air flow in / through the delivery system (e.g., from a flow sensor), ambient temperature, ambient pressure, fingerprint matching data, pod information (e.g., from a pod ID chip), blood oxygen sensing information, and / or carbon dioxide sensing information, information sensed from the user's saliva, etc.). Also, in some embodiments, user data sensed by the sensor(s) 17 in subsequent stages 851, 852, ... may be communicated from the sensor(s) 17 to the delivery system 100 or user device 15 and then to the server system 25 where it may be used to dynamically adjust the treatment program or monitor the patient's progress in the treatment program. The user data sensed by the sensor 17 may include information related to a sensed characteristic of the user, such as temperature, pH, sweat, sugar levels in the blood, nicotine levels in the blood, another characteristic of the user's blood, information from a pacemaker, and / or information related to sensors implanted in the user.

[0131]

[0186] After all the stages for the treatment program including dynamically providing the substance in the aerosol mixture to the user, in the final stage 853, the user device 15 provides app-based user support. In one example, the app-based user support can include positive reinforcement and motivational information to assist the user in maintaining abstinence from nicotine products. In the final stage 853, the user can be provided with questions on the user device 15 to help determine how the user feels / copes with not having nicotine, and the information provided by the user is communicated to the server system 25 and used to evaluate the user's progress in the treatment program. In some examples, information related to the final stage 853 from multiple users is collected by the server system, and this data is used to make changes to the treatment program for future users. Also, in some embodiments, user data sensed by the sensor(s) 17 in stages subsequent to the final stage 853 can be communicated from the sensor(s) 17 to the delivery system 100 or the user device 15 and then to the server system 25, where it can be used to monitor the patient's adherence to the treatment program. The user data sensed by the sensor 17 can include information related to the sensed characteristics of the user. For example, temperature, pH, sweat, blood sugar levels, blood nicotine levels, other characteristics of the user's blood, information from a pacemaker, and / or information associated with sensors implanted in the user.

[0132] (Non-thermal aerosolizer)

[0187] Drug delivery devices can include various types of aerosolizers. For example, they can be thermal or non-thermal. Examples of non-thermal aerosolizers include mechanical (e.g., using a vibrating mesh) and jet nebulizers (e.g., using compressed air). Mesh nebulizers may use electricity to vibrate a piezo element (approximately 128 KHz) that moves the liquid formulation through a fine mesh to generate an aerosol. The diameter of the mesh or opening determines the size of the particles generated. Mesh nebulizers are highly efficient and have minimal residual volumes (0.1-0.5 mL). Mesh nebulizers can utilize two basic mechanisms of action: active vibrating mesh and passive mesh. Active vibrating mesh nebulizers have an aperture plate with 1,000-4,000 funnel-shaped holes that are vibrated by a piezo ceramic element that surrounds the aperture plate. Passive mesh nebulizers (aerosolizers) utilize an ultrasonic horn to push the liquid through the mesh. Adaptive aerosol delivery (AAD) systems, such as I-neb®, are small, battery-powered, lightweight, and quiet drug delivery devices designed to deliver precise and reproducible drug doses. The aerosol is formed by a passive mesh that ejects the aerosol into the breath at the start of inhalation. The dose of drug is controlled by a specific metering chamber. The metering chamber can deliver preset volumes ranging from 0.25 to 1.7 mL, with a residual volume of approximately 0.1 mL. Some systems use an AAD algorithm that delivers the drug in a pulsed manner in 50-80% of each inspiration, based on a rolling average of the last three breaths.

[0133]

[0188] Another type of non-thermal aerosolizer is the ultrasonic nebulizer, which uses ultrasound to generate aerosols. Ultrasonic nebulizers use a transducer to convert electrical energy into high-frequency vibrations. These vibrations are transmitted to the surface of the solution, creating standing waves that generate aerosols (Figure 10). Ultrasonic nebulizers were initially introduced as large-volume nebulizers, most commonly used to deliver hypertonic saline for sputum induction. Small-volume ultrasonic nebulizers are now commercially available for the delivery of inhaled bronchodilators, but should not be used for suspensions such as budesonide. Ultrasonic nebulizers tend to heat the medication. This raises concerns about protein destruction, but does not affect commonly inhaled medications.

[0134]

[0189] The embodiments of the drug delivery system described herein (e.g., for smoking cessation or for delivery of other aerosolized drugs) may use a non-thermal aerosolizer. Figures 9A-9F show some examples of drug delivery systems that use a non-thermal aerosolizer. These drug delivery systems can be used as handheld delivery systems of the system shown in Figure 1, or other systems. These systems, devices, and methods are employed to properly deliver a metered, uncontaminated dose of aerosolized drug or active pharmaceutical ingredient (API) to the respiratory system of a user. Such systems deliver the drug directly to the respiratory system of a user by aerosolizing a desired dose of the drug in liquid form. The user can inhale the aerosolized drug directly into the respiratory system, allowing for more rapid treatment of various medical conditions. It is very important to deliver an accurate and consistent metered dose of aerosolized drug to the user. Furthermore, there is a need for real-time monitoring of drug delivery to a user that can be tracked and adjusted even outside of a doctor's office or medical environment.

[0135]

[0190] The systems, devices, and methods disclosed herein address many of the same issues discussed above for smoking cessation devices, but not others, for drug (medication, active pharmaceutical ingredient ("API") delivery. Current drug delivery systems often provide inconsistent doses by allowing some of the drug to remain in the reservoir in liquid form after the aerosolization process is complete. Aerosolized medications may be delivered with too much or too little force to adequately enter substantially all of the metered dose into the user's respiratory system. Contamination is also a pressing issue for many aerosolized drug delivery systems. Finally, users may receive more personalized, immediate care if medical advisors are able to monitor drug delivery and adjust doses and schedules in real time.

[0136]

[0191] Due to the nature of many APIs and liquid drugs, heat can have destructive effects on the chemical composition. Therefore, aerosolizing the liquid drug with a non-thermal aerosol generator may be necessary to maintain the efficacy of the API. Similar to the smoking cessation system discussed in the previous embodiment, the handheld system can make the aerosolized API available to the user anywhere, anytime. The system can be linked to an application or server to allow medical professionals to monitor or control the user's API intake.

[0137]

[0192] In one embodiment, a liquid drug containing an API may be stored in a container that is coupled to the mesh or membrane. A vibratable element vibrates the mesh for a measured time to cause aerosolization of the liquid drug from the container and then the aerosol travels down a passageway to a mixing chamber. The time the mesh is vibrated may vary the amount of liquid drug that is aerosolized. When multiple aerosol generators are used in the device, they may be operated individually or in combination to create an aerosol mixture of multiple drugs.

[0138]

[0193] In another embodiment, a liquid reservoir between the container containing the drug and the mesh receives a metered amount of drug from the container, and the mesh is then activated to vibrate and convert the dose of liquid containing the API into an aerosol for the user to inhale.

[0139]

[0194] Similar to a smoking cessation program, the drug dosage program can monitor the user's activities and collect accurate and detailed information about the user's use of the drug delivery device as the user progresses through the dosage program. The collected information includes information related to the use characteristics of the delivery device and that the user is unable to collect on his / her own. In one embodiment, the user is "on-boarded" so that a dosage program is individually generated based on the user's individual characteristics, genetic, determined from user interviews and / or testing. The generated program can include an individually tailored dynamic dosage program for the user that is administered using a delivery system that includes a server-based system running a dosage application. The dosage system can also include a mobile device that communicates with the server-based system and provides the user with information related to the dosage program and the user's progress, similar to a smoking cessation system. The drug delivery system can also include a delivery device, or inhalation device, that administers an aerosol mixture including the API to the user based on the dosage program. The delivery device includes multiple sensors associated with its use, and signals from the sensors are used to monitor the user's progress through the delivery program, with the program being dynamically adjusted as needed.

[0140]

[0195] The delivery device and pharmaceutical container can hold multiple medications to be delivered to the patient. For example, liquid APIs can include insulin, asthma medications, COPD medications, hormone therapy, vaccines, pain medications, or other protein formulations. Additionally, the delivery device can include one, two, three, or more aerosol generators and containers, each of which can hold its own drug or aerosol component.

[0141]

[0196] Returning to FIG. 1, similar to that described above with respect to the thermal aerosolizer, the delivery system 10 may be used to program drug doses for a user, if present, with the server system 25, the delivery system 100 used by the user 30, and the computer / user device 15. One or more advisors or physicians 35 may receive information related to the drug dose program and use of the device. This system allows both the user 30 and the physician 35 real-time feedback and control over the delivery of the API in the device. The physician 35 may make changes depending on the user's response to the delivered medication or in response to changes in the user's medical condition.

[0142]

[0197] FIG. 9A illustrates an example of a delivery system 900 having a mechanical aerosolizer. In various embodiments, the delivery system 900 can include many or all of the same components as the previously described delivery system 100 having a thermal aerosolizer. The delivery system 900 includes a delivery device 909 and a pod 950 configured to be removably coupled to the delivery device 909. The delivery device 909 includes components for executing a treatment program that includes delivering a plurality of substances from the pod 950 according to the treatment program. Specifically, the delivery device 909 controls a plurality of aerosolizers in the pod 950 to generate a desired aerosol mixture to be inhaled by a user, similar to the previously disclosed smoking cessation system. When the pod 950 is coupled to the delivery device 909, an aerosolizer driver in the delivery device electrically connects to a corresponding aerosolizer in the pod 950. The aerosolizer driver can independently and separately provide signals to each aerosolizer of the pod 950 to cause the multiple aerosolizers of the pod 950 to generate a desired aerosol mixture of different substances according to a treatment program. When the pod 950 is coupled to the delivery device 909, all or a portion of the pod 950 is disposed within the housing 902. In some examples, a portion of the pod 950 can be coupled to the delivery device 909 and extend from the proximal end 903 of the smoking cessation device 909. In this example, the pod 950 is coupled to the smoking cessation device 909 such that it is in electrical communication with the smoking cessation device 909 as well as in fluid communication with the airflow into and through the housing 902 (e.g., through the opening 906, through the channel 904, and through the opening 908).

[0143]

[0198] FIG. 9B shows a delivery device 909 coupled to a pod 950. FIG. 9C further shows the delivery device 909 (without the pod 950). These embodiments may be similar to those of the delivery device 109 and pod 150, including many of the same or similar components. However, to accommodate a non-thermal aerosol generator, the pod 950 does not have a heating element that turns a liquid into a vapor. Instead, a non-thermal aerosolizer is in place of the previous heating element. The non-thermal aerosolizer may include a vibrating mesh or other non-thermal aerosolizer components. In some embodiments, the pod 950 includes most of the modifications to accommodate the non-thermal aerosolizer. The pod 950 is discussed in more detail in FIG. 9D.

[0144]

[0199] FIG. 9D illustrates a pod 950 utilizing a non-thermal aerosolizer in a drug delivery device. The pod 950 may be used in a device as shown in FIG. 9C. As FIG. 9C illustrates, the pod 950 includes non-thermal aerosolizers 961a-c. The electrical connections 911a-c may each be connected to one of the aerosolizers 961a-c and provide power and / or control information to the aerosolizers 961a-c. When the pod 950 is coupled to the delivery device 909, the electrical connections 111a-c are each coupled to an aerosolizer driver 910a-c. Each aerosolizer 961 includes an aerosol generating component 952, such as a mesh, a membrane, a mechanism for vibrating a mesh or membrane, or a wave generating component. The containers 959a-c are configured to hold a substance (e.g., a fluid or powder containing an API) and are adjacent to passageways 956a-c having a distal end 955 and a proximal end 957. The passageways provide a flow path for the aerosol generated by the aerosol generating component 952 to flow to the mixing chamber 962. The mixing chamber 962 includes a wall 966 that encloses a mixing space 967. In the mixing chamber 962, the aerosol generated by the aerosolizer is readily available for inhalation by a user through an opening 964. In some embodiments, the pod 950 includes one or more power sources that can provide power to the electrical components of the pod 950. The controller circuit 930 can control the aerosolizer system to generate the aerosol formulated by the drug delivery system.

[0145]

[0200] FIG. 9E is a schematic diagram of a non-thermal example circuit 913 that can be used in a drug delivery system for a treatment program, similar to the controller circuit of the device 109 illustrated in FIG. 4. This circuit 913 shows communication lines between the controller circuit 930 and other components of the delivery system. The controller circuit 930 can include one or more hardware processors, which may be the hardware processor 504 illustrated in FIG. 5. In this schematic diagram, the airflow is from left to right such that the intake of air is sensed by the flow sensor 912 and received by the non-thermal aerosolizer 961. The aerosolizer 961 creates an aerosol in the airflow, which then passes through the pressure sensor 958. FIG. 9E shows many of the components shown in FIG. 4, but with a non-thermal aerosolizer instead of a thermal aerosolizer. There may be multiple non-thermal aerosolizers in the device. FIG. 9E also shows some additional components. For example, a flash memory 910 is in communication with the controller circuit 930. The controller circuitry 930 of this example includes a transceiver or other communication circuitry coupled to an antenna 920 that allows the drug dosage circuitry 913 to communicate with a smartphone, another device, or a network. As shown in FIG. 9E, the circuitry 913 can also include a pod ID chip interface 465 (or an aerosolizer chip interface) that communicates with a pod ID chip 963 of the pod 950 to provide signals (e.g., control signals) to the aerosolizer system and / or receive information from the pod 950 when the pod 950 is coupled to the delivery device 909. The circuitry 913 also includes a case data interface 425 that communicates with the controller circuitry 930, a battery manager 420 that manages the power provided to the power source (e.g., battery) 914 of the controller circuitry 930, and a case charging interface 430 that communicates with the controller circuitry 930, for example, to manage the charging of the battery 914.

[0146]

[0201] FIG. 9F is a flow chart illustrating a process 990 for providing an aerosol mixture of doses of a drug during a treatment program. In block 991, the process implements the treatment program on a handheld delivery system having multiple mechanical aerosolizers. In one example, the delivery system is the delivery system 900 shown in FIG. 9B, including a handheld delivery device 909 and a pod 950. In block 992, the process 900 controls the multiple mechanical aerosolizers to generate the aerosol mixture according to the treatment program and based on signals received from one or more sensors of the delivery system, such as a rescue button and / or a flow sensor. The treatment program typically occurs over a period of time, which may include a time portion during which a particular drug is provided to the user in an aerosol mixture. Different pods may be used during each time portion of the treatment program to provide the user with aerosol mixtures of different drugs.

[0147]

[0202] 10A-10L show further details of an example of a smoking cessation treatment program, such as the treatment program shown in FIG. 7Q. Specifically, FIG. 10A-10L illustrate doses that may be provided by the delivery system described herein (e.g., as shown in FIG. 1) according to a treatment program, where the doses of monoprotonated nicotine and free radical nicotine may be varied during different periods of the treatment program, and illustrate varying aerosol droplet diameters during the treatment program such that the aerosol mixture is absorbed into the mouth, throat, or lungs. Using information provided from the user device and / or server system, the delivery system controls multiple aerosolizers to generate aerosol mixtures according to doses for different portions of the treatment program. For example, generating an aerosol mixture having a fixed amount of each of two or three substances and generating an aerosol mixture having a fixed diameter of aerosol droplets in different portions of the treatment program. The term "dosage" or "dose" refers to the mass of active nicotine component per dose. The term "dose-map" refers to a precision medicine-based treatment program (e.g., predictable human therapeutic treatment) that defines the variation of aerosol parameters during the treatment program in an individualized manner that maximizes smoking cessation efficacy. The variation of aerosol parameters allows for an initial replication of the nicotine plasma pharmacokinetic (PK) response that represents the patient's habituated nicotine source (cigarette or vape device), and then gradually reduces the nicotine dose in a manner that minimizes the induction of withdrawal symptoms and cravings in the patient through precise management of nicotine plasma pharmacokinetics that are uniquely related to the patient's phenotype and metabolic response to nicotine.

[0148]

[0203] The term "dose" refers to the amount of use in one "experience" (cigarette) or one "session" (vape device). In this context, the dose is the sum of all nicotine doses "per puff" over the total number of puffs taken by the patient during the experience / session. Specifically, in these examples, the dose discussed in this application refers to the "maximum" possible mass of total nicotine, including monoprotonated nicotine and free radical nicotine species, that can be delivered during one experience / session, defined as consisting of up to 20 puffs from the device, with a certain conversion of liquid mass to aerosol. This concept of dose is, by definition, the upper limit of the amount "actually" delivered to the patient.

[0149]

[0204] The dose actually delivered to the patient will be less than, but not equal to, the maximum value due to a) aerosol losses that occur within the device due to condensation on device surfaces that shape the hydrodynamic path for the aerosol, b) aerosol losses that occur at the device mouthpiece due to asynchronous withdrawal of the device from the patient's mouth upon completion of the puff, and c) aerosol losses that may occur if the patient does not completely inhale the orally delivered aerosol.

[0150]

[0205] The device delivers aerosol to patients during seven periods of their smoking cessation journey: a) switch, b) vigilance, c) start of taper, d) continued taper, e) end of taper, f) low nicotine, and g) device-based relapse prevention.

[0151]

[0206] There are six aerosol variables: 1. Total Nicotine Dose per Experience / Session - TND E (mg) = sum of all doses of nicotine species across the number of puffs taken by the patient; 2. Monoprotonated nicotine dose rate per experience / session - MND E (mg) = percentage of total nicotine dose that is monoprotonated nicotine, 3. Free radical nicotine dose rate per experience / session - FND E(mg) = percentage of total nicotine dose due to free radical nicotine, 4. Aerosol Droplet Size per Experience / Session - ADS E (μm) = mass mean aerodynamic diameter of the aerosol droplets, 5. Free radical nicotine ratio per experience / session - FNR E (dimensionless) = ratio of free radical nicotine dose to total nicotine dose, 6. Enantiomer ratio per experience / session - ENM E (dimensionless) = relative proportion of S fraction to R fraction of nicotine enantiomers in the total nicotine dose.

[0152]

[0207] FIG. 10A is a graph showing an example of the smoking cessation journey duration and tapering parameters implemented in a smoking cessation program. The graph has a vertical axis and a horizontal axis. The vertical axis shows the total nicotine dose (mg) per experience. The horizontal axis shows an example of the duration of a smoking cessation treatment program. In this example, there are seven periods: switching period, caution period, start period, continuation period, end period, nicotine abstinence period, and relapse prevention period, which are briefly described below: Switching Period: The switching period is the start of the smoking cessation journey and is the period during which a patient switches from their source of intake (smoking cigarettes and vaping devices) to the delivery system used in the treatment program (e.g., a delivery system described herein). Warning Period: The warning period is the period during which the patient stops using the intake source and continues to use the delivery system in the normal course of life. Initiation Period: The initiation period is the time to begin tapering using the delivery system. Duration: Duration is the period during which the patient undergoes continued tapering using the delivery device. Termination Period: The termination period is the period during which tapering using the delivery system is stopped. Nicotine abstinence period: A nicotine abstinence period is a period during which a patient maintains low levels of nicotine using a delivery system. Relapse Prevention Period: The relapse prevention period is the period during which the delivery system is no longer used.

[0153]

[0208] Continuing to refer to FIG. 10A, this graph shows the total nicotine dose at the start of the quit journey versus TND START From the end of the waiting period to the end of the onset period, the total nicotine dose decreases at a constant rate from RND E1 #1. From the end of the initiation period to the end of the continuation period, the total nicotine dose decreases at a further constant rate to RND E2 #2. From the end of the continuation period to the end of the termination period, the total nicotine dose is tapered to the targeted low nicotine dose ε. From the start to the end of the nicotine abstinence period, the total nicotine dose is maintained at the target level ε, at which point nicotine use is completely abstained. Then, at the end of the relapse prevention period, use of the delivery system is discontinued. This is followed by a software-based relapse prevention period. Calibrations of the delivery system are performed at different times: once at the start of the switching period, once during the switching period, once at the end of the watch period, once at the end of the initiation period, once at the end of the continuation period, and once at the end of the termination period.

[0154]

[0209] FIG. 10B is a diagram showing the axes of a graph illustrating an example of a dose map specification. Each graph has three vertical axes and one horizontal axis. The horizontal axis shows all smoking cessation treatment periods 2-8 involving a delivery system. The smoking cessation treatment periods 2-8 involving a delivery system are divided into seven periods: a switching period, a warning period, a T-start period, a T-continuation period, a T-end period, a low nicotine period, and a relapse prevention period. The switching period is the period during which the patient begins to switch from smoking cigarettes or vaping devices to a delivery system. The warning period is the period during which the patient uses only the delivery system in normal life. The T-start period is the period during which tapering using the delivery system begins. The T-continuation period is the period during which the patient undergoes a continuation of tapering using the delivery system. The T-end period is the period during which tapering using the delivery system stops. The low nicotine period is the period during which the patient maintains a low level of nicotine using the delivery system. The relapse prevention period is the period during which nicotine is not provided. The first axis on the top left of the graph in FIG. 10B-1 shows the monoprotonated nicotine dose (mg). The axis ranges from 3.0 to 0.0 mg. The second axis on the bottom left side of the graph in FIG. 10B-2 shows the free base nicotine dose (mg). The axis ranges from 0.0 to 3.0 mg. The third axis on the right side of the graph in FIG. 10B-3 shows a dimensionless ratio. This axis reads the dimensionless values ​​of the free base nicotine ratio (FNR) and the enantiomer ratio. This axis ranges from a maximum value of 1.0 to a minimum value of 0.0.

[0155]

[0210] FIG. 10C is a graph showing a hypothetical dose map specification for monoprotonated nicotine dose. Both the vertical and horizontal axes are the same as those described in FIG. 10B. In this hypothetical example, line 1001 shows how the monoprotonated nicotine dose changes from 2.0 mg to 0.0 mg over the entire smoking cessation treatment period 2-8 using the delivery system. From the start of the switch to using the delivery system to the end of T-Start, the amount of monoprotonated nicotine was a constant amount of 2.0 mg. Then, from the end of T-Start to the end of T-Continuation, the monoprotonated nicotine dose decreased at a constant rate from 2.0 mg to 0.5 mg. From the end of T-Continuation to the end of T-End, the amount of monoprotonated nicotine was a constant amount of 0.5 mg. Then, from the end of T-End to the end of the low nicotine period, the monoprotonated nicotine dose decreased at a constant rate from 0.5 mg to 0.0 mg. During the relapse prevention period, the monoprotonated nicotine dose remained at 0.0 mg.

[0156]

[0211] FIG 10D is a graph showing a hypothetical dose map specification for free radical nicotine dose (FND). Both the vertical and horizontal axes are the same as those described in FIG 10B. In this hypothetical example, dashed line 1002 shows the free radical nicotine dose. In this graph, the free radical nicotine dose remained constant at 0.8 mg for all smoking cessation treatment periods 2-8 using the delivery system.

[0157]

[0212] FIG. 10E is a graph showing an example of a hypothetical dose map specification of total nicotine dose (TND) (i.e., the sum of monoprotonated nicotine and free radical nicotine). Both the vertical and horizontal axes are the same as those described in FIG. 10B. In this hypothetical example, dotted line 1001 shows how monoprotonated nicotine dose varies from 2.0 mg to 0.0 mg over the entire smoking cessation treatment using the delivery system, and dashed line 1002 shows that free radical nicotine dose was constant at 0.8 mg. From the start of the switch to using the delivery system to the end of T-Start, the TND was a constant dose of 2.8 mg. Then, from the end of T-Start to the end of T-Continuation, the TND decreased at a constant rate from 2.8 mg to 1.3 mg. From the end of T-Continuation to the end of T-End, the TND was a constant amount of 1.3 mg. Thereafter, the TND steadily decreased from 1.3 mg to 0.8 mg from the end of the T-termination period to the end of the low-nicotine period. During the relapse prevention period, the TND remained at 0.8 mg.

[0158]

[0213] FIG. 10F is a graph showing a hypothetical dose map specification of the free radical nicotine ratio (FNR) (ratio of (free radical nicotine dose) / (total nicotine dose)). This graph can be used to calculate the FNR of a patient over the smoking cessation treatment period using a delivery system. Both the vertical and horizontal axes are the same as described in FIG. 10B. The FNR value can be read off the right vertical axis, which gives a dimensionless ratio. In this hypothetical example, the thin dotted line 1001 shows how the dose of monoprotonated nicotine changes from 2.0 mg to 0.0 mg. The thin dashed line 1002 shows that the dose of free radical nicotine remained constant at 0.8 mg, and the large dashed line 1003 shows how the FNR changes from 0.29 to 1.0 over the entire smoking cessation treatment period using a delivery system. From the start of the switch to using the delivery system to the end of T-start, the FNR is equal to 0.29. Thereafter, from the end of T-Initiation to the end of T-Continuation, the FNR increased at a steady rate to 0.62. From the end of T-Continuation to the end of T-End, the FNR remained constant at 0.62. Thereafter, from the end of T-End to the end of the low-nicotine period, the FNR increased at a steady rate to 1.0. During the relapse prevention period, the FNR remained constant at 1.0.

[0159]

[0214] FIG. 10G is a graph showing a hypothetical dose map specification of the enantiomer ratio (ratio of (S-nicotine) / (R-nicotine)). This graph can be used to show the enantiomer ratio, i.e. the ratio of different enantiomers of nicotine used by a patient over the entire smoking cessation treatment period using the delivery system. Both the vertical and horizontal axes are the same as described in FIG. 10B. The value of the enantiomer ratio can be read off the right vertical axis, which gives a dimensionless ratio. In this hypothetical example, the light dots and dashed line 1004 show that the enantiomer ratio remained constant at 0.99 over the entire smoking cessation treatment period using the delivery system.

[0160]

[0215] FIG. 10H is a graph showing a hypothetical dose map specification of variable aerosol droplet size (ADS). Both the vertical and horizontal axes are the same as those described in FIG. 10B. In this hypothetical example, dotted line 1001 shows how the monoprotonated nicotine dose varies from 2.0 mg to 0.0 mg, and dashed line 1002 shows that the free radical nicotine dose was kept constant at 0.8 mg throughout the entire smoking cessation treatment period using the delivery system. From the start of the switch to using the delivery system to the end of the T-continuation, the ADS is 1.0 μm or less, as shown in the clear area between the monoprotonated line 1001 and the free radical nicotine dose line 1002. Then, from the end of the T-continuation period to the end of the relapse prevention period, the size of the ADS increases to 10.0 μm or more, as shown in the yellow area between the monoprotonated nicotine dose line 1001 and the free radical nicotine dose line 1002.

[0161]

[0216] FIG. 10I is a graph showing an example of a hypothetical dose map specification of the previous six combined tapering variables based on initial values ​​of TND, FND, and FNR, as well as a tapered TND reduction goal, and plotted as a function of smoking cessation journey duration. This is a graph showing all variables collected and calculated to reach a reduced TND goal. Both the vertical and horizontal axes are the same as those described in FIG. 10B. In this hypothetical example, line 1001 shows a monoprotonated nicotine dose varying from 2.0 mg to 0.0 mg, line 1002 shows a constant free-base nicotine dose of 0.8 mg, line 1003 shows an FNR varying from 0.29 to 1.0, and line 1004 shows a constant enantiomer ratio of 0.99 remaining over the entire smoking cessation treatment period 2-8 using the delivery system. This graph shows that at a constant FND, as the monoprotonated nicotine dose decreases, the TND also decreases, but the FNR increases and the enantiomer ratio remains constant throughout the entire smoking cessation treatment period using the delivery system.

[0162]

[0217] Figure 10J shows a patient who smokes tobacco (Patient 1 - Marlboro Red @ 2.6 mg / cigarette, FNR = 0.11, tapering regime T FND10B ) (FNR constant). The vertical and horizontal axes are the same as those described in FIG. 10B. In this example, patient 1 first receives a monoprotonated nicotine dose MPD E Higher nicotine dose of 1.78mg, FND E Relatively low at 0.22mg, ADS E Patient 1 had an FNR of 1.0 μm or less and smoked a full-flavored regular cigarette with the end lit. E The enantiomeric ratio ENM is a constant value of 0.99, as shown by line 1004. The TND is the area under lines 1001 and 1002. The TND is the area under lines 1001 and 1002 from the start of the switch to using the delivery system to the end of the warning period. E is 2.0 mg. From the start of T-initiation to the end of the low nicotine period, the TND decreases from 2.0 mg, and during the relapse prevention period the TND is 0.0 mg. Towards the end of the smoking cessation process, patient 1 reduces the nicotine dose to a very low level, maintaining the free radical ratio for sensory response and increasing the ADS to reduce absorption.

[0163]

[0218] Figure 10K shows the results of a vaping patient (Patient 2 - Vaporesso XROS & Zen-Haus e-liquid @ 17mg / mL, FNR=0.84, tapering regime T FND 10B. In this example, patient 2 was initially administered a monoprotonated nicotine dose MPD E 0.25mg, free radical nicotine dose FND E 0.99mg, ADS E For patient 2, the FNR was ≥10.0 μm and the patient was using a regular vaping device. E The enantiomeric ratio ENM is a constant value of 0.99, as shown by line 1004. The TND is the area under lines 1001 and 1002. The TND is the area under lines 1001 and 1002 from the start of the switch to using the delivery system to the end of the warning period. Eis 1.24 mg. From the start of T-initiation to the end of the low nicotine period, the TND decreases from 1.24 mg, and during the relapse prevention period the TND is 0.0 mg. Towards the end of the smoking cessation treatment, patient 2 reduces the nicotine dose to a very low level to maintain the free radical ratio for sensory response and to keep the ADS constant throughout the treatment.

[0164]

[0219] Figure 10L shows a patient who smokes tobacco (Patient 3 - Winston Blue @ 1.7 mg / cigarette, FNR = 0.05, tapering regime T FND Initial (constant FNR) T FNR 10B. The vertical and horizontal axes are the same as those described in FIG. 10B. In this example, the FNR is constant at first, and then the FND is constant. Patient 3 had an MPD of monoprotonated nicotine. E A moderate amount of 1.78mg of free radical nicotine FND E Relatively low at 0.22mg, ADS E ≤1.0 μm and smokes mild, end-lit, conventional cigarettes. For patient 3, the enantiomer ratio ENM remained constant at 0.99 from the start of the switch to use of the delivery system to the end of the low-nicotine period using the delivery system. The TND is the area under lines 1001 and 1002. From the start of the switch to use of the delivery system to the end of the caution period, the TND E The TND is 2.0 mg. From the start of T-initiation to the end of the low-nicotine period, both the monoprotonated nicotine dose and the free radical nicotine dose are decreased, and the TND is decreased from 2.0 mg, and during the relapse prevention period, the TND is 0.0 mg. FNR E remains constant at 0.11 from the start of the switch to use of the delivery system to the end of the T-Continuation period. Thereafter, the FNR increases steadily from 0.11 to 1.0 from the start to the end of the T-End period, and remains constant from the start to the end of the low nicotine period. Towards the end of the smoking cessation process, patient 3 uses a very low nicotine dose, maintains the free radical ratio for sensory response and maximum bioavailability, and reduces the ADS to slow absorption.

[0165] (More examples)

[0220] The present disclosure includes numerous examples of drug delivery systems. Such systems can be implemented in thermal or non-thermal aerosolizer systems. In one embodiment, the drug delivery system includes a housing having a distal end and a proximal end, a channel in the housing for receiving air, an opening for communicating the air to an aerosolizer pod coupled to the housing, and an opening on the proximal end of the housing configured to receive the aerosolizer pod therein. In some implementations, the housing is configured to at least partially surround the aerosolizer pod when the aerosolizer pod is disposed within the housing. The system may include a flow sensor positioned to sense air flowing through the channel, a power source, and a controller circuit coupled to the power source, the controller circuit including a hardware controller coupled to the flow sensor, the aerosolizer system, and the rescue button, the hardware controller including a hardware processor and a non-transitory computer-readable medium in communication with the hardware controller, the computer-readable medium configured to store dose program information and executable instructions, and when the executable instructions are executed, the hardware controller is configured to execute a dose program including receiving input signals from the flow sensor and the rescue button, and individually controlling the aerosolizer system to provide an aerosolizer generation signal for controlling the aerosolizer of the aerosolizer pod to generate an aerosol mixture based on at least the received input signals and the dose program information.The delivery system may further include an aerosolizer pod having a distal end and a proximal end, an inlet on the distal end for receiving air flowing through the channel, an outlet on the proximal end for transmitting the aerosol mixture from the aerosolizer pod, and an aerosolizer system including a first, a second, and a third aerosolizer, the first, the second, and the third aerosolizer including electrical connections that electrically couple to the first, the second, and the third aerosol drivers, respectively, when the aerosolizer pod is received in the housing. The first, the second, and the third aerosolizer may also include a mechanical aerosolizer. The mechanical aerosolizer may include a membrane. The mechanical aerosolizer may be configured to vibrate the membrane. In some examples, the mechanical aerosolizer may include a piezoelectric mechanism that vibrates the membrane. The membrane may be disposed between the medicament in the container and the channel in the housing. When activated, a mechanical aerosolizer can use a membrane to convert a dose of medication into an aerosol that can be inhaled by the user.

[0166] (System Implementation)

[0221] Various embodiments of the present disclosure may be integrated systems, methods, and / or computer program products at any possible level of technical detail. The computer program product may include a computer-readable storage medium(s) having computer-readable program instructions thereon for causing a processor to execute aspects of the present disclosure. For example, the functions described herein may be accomplished because software instructions are executed by and / or in response to software instructions executed by one or more hardware processors and / or any other suitable computing devices. The software instructions and / or other executable code may be read from the computer-readable storage medium(s). The computer-readable storage medium may also be referred to herein as a computer-readable storage device.

[0167]

[0222] A non-transitory computer-readable storage medium may be a tangible device that can hold and store data and / or instructions used by an instruction execution device. A computer-readable storage medium may be, for example, but not limited to, an electronic storage device, a magnetic storage device, an optical storage device, an electromagnetic storage device, a semiconductor storage device, or any suitable combination of the above. More specific examples of computer-readable storage media include the following non-exhaustive list: portable computer diskettes, hard disks, solid-state drives, random access memories (RAMs), read-only memories (ROMs), erasable programmable read-only memories (EPROMs or flash memories), static random access memories (SRAMs), portable compact disk read-only memories (CD-ROMs), digital versatile disks (DVDs), memory sticks, floptical disks, punch cards or mechanically encoded devices such as raised structures in grooves with instructions recorded therein, and any suitable combination of the above. As used herein, computer-readable storage media is not to be construed as being "per se" ephemeral signals such as radio waves or other freely propagating electromagnetic waves, electromagnetic waves propagating through waveguides or other transmission media (e.g., light pulses passing through fiber optic cables), or electrical signals transmitted over electrical wires.

[0168]

[0223] The computer-readable program instructions described herein can be downloaded from a computer-readable storage medium to each computer / processor device, or to an external computer or external storage device, over a network, such as the Internet, a local area network, a wide area network, and / or a wireless network. The network can include copper transmission cables, optical transmission fiber, wireless transmission, routers, firewalls, switches, gateway computers, and / or edge servers. A network adapter card or network interface in each computer / processor device receives the computer-readable program instructions from the network and forwards the computer-readable program instructions for storage in a computer-readable storage medium in each computer / processor device.

[0169]

[0224] Computer readable program instructions (also referred to herein, e.g., as "code," "instructions," "modules," "applications," "software applications," etc.) for performing the operations of the present disclosure may include either assembler instructions, instruction set architecture (ISA) instructions, machine instructions, machine-dependent instructions, microcode, firmware instructions, state setting data, integrated circuit configuration data, or source or object code written in any combination of one or more programming languages, including object-oriented programming languages ​​such as Java, C++, and procedural programming languages ​​such as the "C" programming language. The computer readable program instructions may be callable from other instructions or from themselves, and / or may be launched in response to a detected event or interrupt. Computer readable program instructions configured to execute on a computing device may be provided on a computer readable storage medium and / or provided as a digital download (and may originally be stored in a compressed or installable format that requires installation, decompression, or decryption before execution) that may later be stored on the computer readable storage medium. Such computer readable program instructions may be stored, in part or in whole, on a memory device (e.g., a computer readable storage medium) of the executing computing device for execution by the computing device. The computer readable program instructions may execute entirely on the user's computer (e.g., execution computing device) as a stand-alone software package, partially on the user's computer, partially on the user's computer and partially on a remote computer, or entirely on a remote computer or server. In the latter scenario, the remote computer may be connected to the user's computer via any type of network, including a local area network (LAN) or a wide area network (WAN), or may be connected to an external computer (e.g., via the Internet using an Internet Service Provider).In some embodiments, electronic circuitry including, for example, a programmable logic circuit, a field programmable gate array (FPGA), or a programmable logic array (PLA) can utilize state information of computer readable program instructions to execute computer readable program instructions and personalize the electronic circuitry to perform aspects of the present disclosure.

[0170]

[0225] Aspects of the present disclosure are described herein with reference to flowchart illustrations and / or block diagrams of methods, apparatus (systems), and computer program products according to embodiments of the present disclosure. It will be understood that each block of the flowchart illustrations and / or block diagrams, and combinations of blocks in the flowchart illustrations and / or block diagrams, can be implemented by computer readable program instructions.

[0171]

[0226] These computer-readable program instructions may be provided to a processor of a general purpose computer, special purpose computer, or other programmable data processor device, such that the instructions, executed via the processor of the computer or other programmable data processor device, create a machine that creates means for performing the function / operation identified in the block(s) of the flowcharts and / or block diagrams. These computer-readable program instructions may be stored on a computer-readable storage medium and may direct a computer, programmable data processor device, and / or other device to function in a particular manner, such that a computer-readable storage medium having instructions stored therein includes an article of manufacture that includes instructions that implement aspects of the function / operation identified in the block(s) of the flowcharts and / or block diagrams.

[0172]

[0227] The computer readable program instructions may be loaded into a computer, other programmable data processor device, or other device such that the instructions, executed on the computer, other programmable device, or other device, generate a sequence of operational steps executed on the computer, other programmable device, or other device to generate a computer-implemented process to perform the functions / operations identified in the block(s) of the flowcharts and / or block diagrams. For example, the instructions may initially be borne on a magnetic disk or solid-state drive of a remote computer. The remote computer may load the instructions and / or modules into its dynamic memory and transmit the instructions using a modem over a telephone, cable, or optical line. A modem locally connected to the server computer system may receive the data over the telephone / cable / optical line and place the data on a bus using a converter device including appropriate circuitry. The bus conveys the data to the memory from which the processor retrieves and executes the instructions. The instructions received by the memory may optionally be stored on a storage device (e.g., a solid-state drive) before or after execution by the computer processor.

[0173]

[0228] The diagrams in the drawings illustrate the architecture, functionality, and operation of possible implementations of systems, methods, and computer program products according to various embodiments of the present disclosure. In this regard, each block in a flowchart or block diagram may represent a module, segment, or portion of instructions, including one or more executable instructions for implementing a specified logical function(s). In some alternative implementations, the functions described in the blocks may differ from the order described in the figures. For example, two blocks shown in succession may in fact be executed substantially simultaneously, and depending on the functionality involved, the blocks may sometimes be executed in the reverse order. Furthermore, in some embodiments, certain blocks may be omitted. Also, the methods and processes described herein are not limited to a specific order, and the blocks or states associated therewith may be executed in other orders as appropriate.

[0174]

[0229] It should also be noted that each block illustrated in the block diagrams, and combinations of blocks illustrated in the block diagrams and / or flowchart diagrams, may be implemented by special-purpose hardware-based systems performing the specified functions or operations or executing a combination of special-purpose hardware and computer instructions. For example, any of the processes, methods, algorithms, elements, blocks, applications, or other functions (or portions of functions) described in the previous sections may be implemented via electronic hardware in the form of application-specific processors (e.g., application-specific integrated circuits (ASICs)), programmable processors (field programmable gate arrays (FPGAs)), application-specific circuitry, etc. (any of which may be combined with custom hardwired logic, logic circuits, ASICs, FPGAs, etc., with custom programming / execution of software instructions to accomplish the techniques), and / or automated in whole or in part.

[0175]

[0230] Any of the above-mentioned processors and / or devices incorporating any of the above-mentioned processors may be referred to herein as, for example, a "computer," a "computing device," a "computing device," a "hardware computing device," a "hardware processor," a "processing unit," etc. The computing devices of the above embodiments may generally (but not necessarily) be controlled and / or regulated by operating system software, such as, for example, Mac® OS, iOS®, Android®, Chrome® OS, Windows® OS (e.g., Windows® XP, Windows® Vista, Windows® 7, Windows® 8, Windows® 10, Windows® Server, etc.), Windows® CE, Unix®, Linux®, SunOS®, Solaris®, Blackberry® OS, VxWorks®, or other suitable operating systems. In other embodiments, the computing device may be controlled by its own operating system. A traditional operating system, among other things, controls and schedules computer processes for execution, performs memory management, provides file system, networking, and I / O services, and provides user interface facilities such as a graphical user interface ("GUI"), among other things.

[0176]

[0231] As mentioned above, in various embodiments, certain functions may be accessible by a user via a web-based viewer (such as a web browser) or other suitable software program. In such an embodiment, the user interface may be generated by a server computer system and sent to the user's web browser (e.g., running on the user's computer system). Alternatively, data necessary to generate the user interface (e.g., user interface data) may be provided by the server computer system to the browser, where the user interface may be generated (e.g., the user interface data may be executed by the browser accessing a web service and configured to render the user interface based on the user interface data). The user may then interact with the user interface via the web browser. The user interface of certain embodiments may be accessed through one or more dedicated software applications. In certain embodiments, one or more of the computer devices and / or systems of the present disclosure may include a mobile computing device, and the user interface may be accessed via such a mobile computing device (e.g., a smartphone and / or tablet). Many variations and modifications may be made to the embodiments described above, and it is understood that the elements are one of other possible examples. All such variations and modifications are intended to be included within the scope of the present disclosure herein. The above description describes certain embodiments in detail. However, no matter how detailed the above is, it will be understood that the systems and methods can be implemented in many ways. Also, as noted above, the use of a particular term in describing a particular feature or aspect of the systems and methods does not imply that the term is redefined herein to be limited to include any particular feature of the feature or aspect of the systems and methods with which the term is associated.

[0177]

[0232] In particular, conditional language such as "can," "may," "might," or "could" is intended to generally convey that certain embodiments include certain features, elements, and / or steps and other embodiments do not, unless specifically stated otherwise or understood otherwise within the context in which it is used. Thus, such conditional language does not generally imply that features, elements, and / or steps are in any way required by one or more embodiments, or that one or more embodiments necessarily include logic for determining, with or without user input or prompting, whether those features, elements, and / or steps are included or performed in any particular embodiment.

[0178]

[0233] The term "substantially" when used in combination with the term "real time" forms a phrase that is readily understood by those of ordinary skill in the art, including, for example, speeds that have little or no delay or latency, or where such delay is sufficiently short so as not to confuse, annoy, or otherwise annoy the user.

[0179]

[0234] Conjunctions such as "at least one of X, Y, Z" or "at least one of X, Y, or Z" are to be understood in conjunction with the context as commonly used to convey that an item, term, etc. may be either X, Y, or Z, or any combination thereof, unless otherwise noted. For example, the term "or" is used in an inclusive (rather than exclusive) sense, so that, for example, when used to connect a list of elements, the term "or" may mean one, some, or all of the elements in the list. Thus, such conjunctive words are not generally intended to imply that a particular embodiment requires that at least one of X, at least one of Y, and at least one of Z, respectively, be present.

[0180]

[0235] The term "a" as used herein should be given an inclusive, not an exclusive, interpretation. For example, unless otherwise specified, the term "a" should not be understood to mean "exactly one" or "only one," but instead means "one or more" or "at least one," regardless of whether the term "a" is used in the claims or elsewhere in the specification, and regardless of the use of quantifiers such as "at least one," "one or more," or "plurality" in the claims or elsewhere in the specification.

[0181]

[0236] The terms "including" and "consisting of" as used herein should be given an inclusive interpretation rather than an exclusive one. For example, a general purpose computer consisting of one or more processors should not be interpreted as excluding other computer components, but may include components such as memory, input / output devices, and / or network interfaces, among others.

[0182] (Example of embodiment)

[0237] Embodiment 1: A system includes a delivery device, the delivery device having a housing, a channel in the housing, the channel structured to receive air from an opening in the housing and transmit the air to an aerosolizer pod coupled to the delivery device, a flow sensor positioned to sense air flowing through the channel, first, second, and third aerosolizer drivers each having an electrical connection configured to electrically couple to a first, second, and third aerosolizer, respectively, of the aerosolizer pod coupled to the delivery device, and a controller circuit coupled to a power source. The controller circuit includes a transceiver electrically coupled to the first, second, and third aerosolizer drivers and the flow sensor, and a hardware controller, the controller circuit configured to individually control the first, second, and third aerosolizer drivers to provide aerosol generating signals to the first, second, and third aerosolizers to generate an aerosol mixture based at least in part on the treatment program received utilizing the transceiver, and a user computing device including an application that communicates with the delivery system via the transceiver.

[0183]

[0238] Embodiment 2: The treatment program system of embodiment 1, further comprising a server system configured with a hardware processor and a non-transitory computer readable storage medium encoding a treatment program including instructions executable by an operating system for controlling generation of an aerosol mixture over time in accordance with the treatment program and providing treatment program information to a delivery system to control generation of the aerosol mixture by the delivery system.

[0184]

[0239] Embodiment 3: The system described in embodiment 2, wherein the treatment program information provided to the delivery system includes information for individually controlling the first, second, and third aerosolizer drivers to provide signals to first, second, and third aerosolizers coupled to the first, second, and third aerosolizer drivers, respectively, to generate a desired aerosol mixture of a first aerosol generated from a first substance, a second aerosol generated by a second substance, and a third aerosol generated by a third substance.

[0185]

[0240] Embodiment 4: A system described in any one of embodiments 1 to 3, wherein the treatment program information provided to the delivery system includes information for individually controlling the first, second, and third aerosolizer drivers to provide signals to the first, second, and third aerosolizers coupled to the first, second, and third aerosolizer drivers to generate first, second, and third aerosols having aerosol droplets of a certain diameter.

[0186]

[0241] Embodiment 5: A system described in any one of embodiments 1 to 4, wherein the treatment program information provided to the delivery system includes information for individually controlling the first, second, and third aerosolizer drivers to provide signals to first, second, and third aerosolizers coupled to the first, second, and third aerosolizer drivers to generate first, second, and third aerosols having aerosol droplets of a first diameter for a first portion of time and having aerosol droplets of a second diameter for a second portion of time.

[0187]

[0242] Embodiment 6: A method for smoking cessation includes providing a delivery system including a delivery device, the delivery device comprising: a housing; a channel in the housing, the channel structured to receive air from an opening in the housing and transmit the air to an aerosolizer pod coupled to the delivery device; a flow sensor disposed to sense air flowing through the channel; first, second, and third aerosolizer drivers configured to electrically couple to first, second, and third aerosolizers, respectively, of the aerosolizer pod coupled to the delivery device; a rescue button configured, when actuated by a user, to provide a signal indicating a user's need for an additional dose of an aerosol mixture; a power source; and a controller circuit coupled to the power source, the controller circuit including a hardware controller electrically coupled to the first, second, and third aerosolizer drivers, the flow sensor, and the rescue button, the hardware controller comprising a hardware processor and a non-transitory computer readable medium in communication with the hardware controller. and a computer readable medium configured to store treatment program information and to store executable instructions that, when executed, configure the hardware controller to individually control three aerosolizer drivers to provide aerosol generating signals to first, second and third aerosolizers of a pod coupled to the delivery device, respectively, to generate an aerosol mixture based at least in part on the stored smoking cessation treatment program and information received from the flow sensor and the rescue button. a controller circuit; and an aerosolizer pod, the aerosolizer pod including an aerosolizer system including first, second, and third aerosolizers, the pod being configured to be removably coupled to a delivery device, each of the first, second, and third aerosolizers having an electrical connection to electrically couple to one of the first aerosolizer driver, the second aerosolizer driver, and the third aerosolizer driver of the delivery device; a first container for holding a first substance, a second container for holding a second substance,and a third container holding a third substance, the first, second, and third containers being structured to deliver the first, second, and third substances to the first, second, and third aerosolizers, respectively, where the first substance is free radical nicotine and the second substance is monoprotonated nicotine; and generating an aerosol mixture in accordance with a smoking cessation treatment program, the aerosol mixture being dynamically altered over a period of time to have different aerosol droplet sizes and different concentrations of the first, second, and third substances based at least in part on received signals from the flow sensor and the rescue button, and smoking cessation treatment program information stored in a non-transitory computer readable medium.

[0188]

[0243] Embodiment 7: A method for smoking cessation, the method comprising: providing signals from a hardware controller in a handheld delivery device to first, second and third aerosolizer drivers in the delivery device to dynamically control first, second and third aerosolizers in a pod coupled to the delivery device to generate an aerosol mixture that is dynamically modified over a period of time to have different aerosol droplet sizes and different concentrations of a first substance based at least in part on received input signals from one or more flow sensors and smoking cessation treatment program information stored in a non-transitory computer readable medium coupled to the hardware controller, the method being performed by the controller executing computer executable instructions stored in the non-transitory computer readable medium that, when executed, cause the hardware controller to provide signals to the first, second and third aerosolizer drivers in accordance with the smoking cessation program.

[0189]

[0244] Embodiment 8: A delivery system for providing an aerosol mixture in a treatment program for smoking cessation comprises an aerosolizer system including a first, second, and third aerosolizer, and a pod including first, second, and third containers in communication with the first, second, and third aerosolizers, respectively, each container holding a substance used to generate an aerosol mixture according to the treatment program, the pod and a delivery device to which the pod is removably coupleable, the delivery device including a housing and a channel structured to receive air from an opening in the housing and transmit the air to an aerosolizer pod coupled to the delivery device, a flow sensor positioned to sense air flowing through the channel, and first, second, and third aerosolizer drivers configured to electrically couple to the first, second, and third aerosolizers of the pod, respectively, when the pod is coupled to the delivery device, and a first, second, and third aerosolizer driver configured to electrically couple to the first, second, and third aerosolizers of the pod, respectively, when actuated by a user, to inform the user of an additional dose of the aerosol mixture. a rescue button configured to provide a signal indicating the need for a treatment program; a power source; and a controller circuit coupled to the power source, the controller circuit including a hardware controller electrically coupled to first, second, and third aerosolizer drivers, a flow sensor, and the rescue button, the hardware controller including a hardware processor and a non-transitory computer-readable medium in communication with the hardware controller, the computer-readable medium storing treatment program information and configured to store executable instructions that, when executed, configure the hardware controller to individually control the three aerosolizer drivers to provide aerosol generating signals to the first, second, and third aerosolizers, respectively, to generate an aerosol mixture based at least in part on the stored treatment program and information received from the flow sensor and the rescue button.

[0190]

[0245] Embodiment 9: A delivery system according to embodiment 8, wherein the three aerosolizers are thermal aerosolizers.

[0191]

[0246] Embodiment 10: A delivery system as described in embodiment 8, wherein the three aerosolizers are mechanical aerosolizers.

[0192]

[0247] Embodiment 11: A delivery system according to embodiment 8, wherein the first container contains free radical nicotine and the second container contains monoprotonated nicotine.

[0193]

[0248] Embodiment 12: A computer-implemented method for providing a treatment program for smoking cessation includes generating a smoking cessation treatment program including a plurality of treatment periods based on received patient information including a nicotine metabolic rate, and communicating aerosol mixture information to a handheld delivery system including three substances used to generate an aerosol mixture provided to the patient based on the treatment program, the aerosol mixture information indicating, for each of the plurality of treatment periods, an amount of each of the three substances to be included in the aerosol mixture and a droplet size of the aerosol droplets in the aerosol mixture, the method being executed by one or more computer hardware processors executing a plurality of computer readable instructions stored on a non-transitory computer memory.

[0194]

[0249] Embodiment 13: The method of embodiment 12, further comprising generating, on the delivery system, the aerosol mixture based on the aerosol mixture information.

[0195]

[0250] Embodiment 14: The method of any one of embodiments 12 or 13, further comprising the steps of receiving usage information from the delivery system and communicating updated aerosol mixture information to the delivery system based at least in part on the usage information.

[0196]

[0251] Embodiment 15: A computer-implemented method for providing a substance to a user includes providing aerosol generation information based on a treatment program generated based on user input and test data of the user's nicotine metabolic rate (NMR) to a handheld delivery device including three aerosolizer drivers, and generating different aerosol mixtures for inhalation by the user over a period of time by providing drive signals from the three aerosolizer drivers to control the three aerosolizers to generate an aerosol mixture having a composition of the three substances and to control the three aerosolizers to generate an aerosol having a certain aerosol droplet diameter in accordance with the treatment program.

[0197]

[0252] Embodiment 16: The method of embodiment 15, wherein the aerosol generation information is provided from a user device to a handheld delivery device.

[0198]

[0253]

[0046] Embodiment 17: The method of embodiment 16, wherein the user device is a mobile computing device.

[0199]

[0254] Embodiment 18: The method of embodiment 16, wherein the user device is a smartphone, a tablet computer, or a laptop computer.

[0200]

[0255] Although the above detailed description shows, describes, and points out novel features applied to various embodiments, it can be understood that various omissions, substitutions, and changes in the form and details of the illustrated devices or processes can be made without departing from the spirit of the present disclosure. As can be recognized, certain embodiments of the invention described herein can be implemented in forms that do not provide all of the features and advantages set forth herein, since some features can be used or implemented separately from other features. The scope of the specific invention disclosed herein is indicated by the attached embodiments, not by the foregoing description. All changes that come within the meaning and equivalence of the embodiments are embraced within their scope. [Explanation of symbols]

[0201] (List of specific parts) For ease of reference, the following is a list of specific components described and enumerated in this disclosure with reference to the above-enumerated figures of the smoking cessation system. Other components not listed below may also be included in the drug delivery treatment system. Any aspect of the items in the following list, or items illustrated and / or described in the figures and description, whether or not separately named herein, may form part of various embodiments of the invention and may provide a basis for claim limitations relating to such aspects, with or without additional description. Particular enumerated items in the figures include: 10 Treatment systems (such as smoking cessation systems) 15 User Devices (Mobile Devices / Smartphones / Computers, etc.) 17 Sensors (wearables, patches, etc.) 20 Network 25 Server systems (e.g. cloud-based server systems) 30 users 35 Advisor / Doctor(s) 40 Communication link between delivery device and user device 41 Communications link between mobile device and network 42 Optional communication links between smoking cessation devices and networks 43 Network and Advisor / Physician Communication Links 44 Communication link between server system and network 46 Communication link between sensor and user device 47 Communication link between sensor and delivery device 100 Delivery system (such as delivery device 109 and pod 150) 101 housing distal end 102 Housing 103 Housing proximal end 104 Channels 105 Housing opening for receiving aerosolizer system 106 Air intake opening 107 Channel proximal end 108 Proximal end opening of channel for supplying air to the aerosolizer system 109 Delivery Device (Pen) 110 Aerosolizer Driver 111 Electrical Connection 112 Flow Sensor 113 Circuit 114 Power source (battery, etc.) 116 Rescue Button 118 Fingerprint Sensor 119 Carbon Dioxide Sensor / Oxygen Sensor 120 Antenna 121 Carbon Dioxide Sensor 122 Channel Distal End 130 Controller 140 Cavity for accepting an aerosolizer system 141 Smoking cessation device exhaust vent 145 Substances (in aerosol containers) 150 Aerosolizer System (Pod) 151 Distal Aerosolizer System 152 Heating Element 153 Proximal Aerosolizer System 154 Aerosolizer intake (opening) 155 Proximal end passage Aisle 156 157 Distal end of passage 158 Temperature Sensor 159 Aerosol containers 160 Density Sensor 161 Aerosolizer (unit) 162 Aerosol Mixing Chamber 163 Pod ID Chip 164 Mixing chamber outlet (opening) for supplying the aerosol mixture 165 cases 166 Mixing chamber wall 167 Mixing space in mixing chamber (volume) 167 Charging connection to the pen 168 Case Battery 169 Charging port 170 Mixing chamber inlet 171 Sensor port 172 Exhaust port sensor 405 Ambient Temperature Sensor 407 Ambient Pressure Sensor 410 Flash Memory 415 LED 420 Battery Manager 425 Case Data Interface 430 Case / Charging Interface 465 Pod ID Chip Interface 500 Computer Systems 502 Communication Bus 504 Hardware Processor 506 Non-transient memory (components) 510 Storage device (e.g. solid-state memory) 512 Display 514 Input Control 518 Communication Interface 601 Puff Data 602 How to use 603 Profile 604 Data Entry 605 Progress 606 Output 607 Smoking Cessation Schedule 608 Smoking Cessation Application 801 Onboarding Phase 802 Tobacco tapering phase 803 Nicotine Tapering Phase 804 Placebo Use Phase 805 Software Support Phase 850 Treatment Program Phase 1 (Post-Onboarding) 851 Treatment Program Phase 2 852 Treatment Program Phase (N-1) 853 Treatment Program Phase N 900 Drug Delivery Systems 901 Distal end 902 Housing 903 Proximal end 904 Channel Housing opening to accept 905 pod 906 Air Intake 907 Ambient Temperature Sensor 908 Opening 909 Drug delivery devices 910 Aerosolizer Driver 911 Electrical Connection 912 Flow Sensor 913 Ambient Pressure Sensor 914 Power supplies (batteries, capacitors, etc.) 916 Rescue Button 918 Fingerprint Sensor 920 Antenna 930 Controller Circuit Cavity to accept 940 pods 950 pod 951 Pod Distal End 952 Non-thermal aerosol generating components 953 Pod Proximal End 954 Containers (for holding drugs) 955 Distal end passage Aisle 956 957 Proximal end passage 959 Drug containers 960 Sensors (Density, Temperature, etc.) 961 Non-thermal aerosolizer assembly 962 Mixing Chamber 963 Pod ID Chip 964 Opening, exhaust port through which aerosols leave the pod 966 Wall 967 Mixing space (cavity)

Claims

1. A delivery system for providing an aerosol mixture in a treatment program for smoking cessation, comprising a delivery device, the delivery device comprising: a channel structured to convey air to two or more aerosolizers; a flow sensor disposed to sense air flowing through the channel; two or more aerosolizer drivers; a controller circuit, the controller circuit comprising a hardware controller electrically coupled to the two or more aerosolizer drivers and the flow sensor, the hardware controller comprising a hardware processor and a non-transitory computer-readable medium communicating with the hardware controller, the non-transitory computer-readable medium storing treatment program information and configured to store executable instructions, the executable instructions, when executed, cause the hardware controller to individually control the two or more aerosolizer drivers to provide aerosol generation signals for two or more aerosolizers and to generate an aerosol mixture based at least in part on the stored treatment program and information received from the flow sensor; a controller circuit; A delivery system for providing an aerosol mixture in a treatment program for smoking cessation.

2. Further comprising a pod including the two or more aerosolizers, the delivery device further comprising a housing structured to couple to the pod, the two or more aerosolizers being coupled to the two or more aerosolizer drivers when the pod is coupled to the housing. The delivery system according to claim 1.

3. Further comprising a pod removably attachable to the delivery device, the pod including two or more containers each holding a substance used to generate the aerosol mixture. The delivery system according to claim 1.

4. The pod includes an ID chip, and the delivery device further includes an aerosolizer pod interface configured to sense the ID chip and communicate the ID chip to the hardware controller to identify the pod and the substances contained therein. The delivery system according to claim 3. **Claim 5**: The delivery device further includes a rescue button, and the rescue button is configured to provide a signal that provides an additional dose of the aerosol mixture according to the treatment program when actuated. When the executable instructions are executed, for the hardware controller, the two or more aerosolizer drivers are individually controlled to provide aerosol generation signals for two or more aerosolizers, and are configured to generate an aerosol mixture based at least in part on information received from the rescue button. The delivery system according to claim 1. **Claim 6** The pod includes the two or more aerosolizers. The delivery system according to claim 1. **Claim 7** The two or more aerosolizers are mechanical aerosolizers. The delivery system according to claim 1. **Claim 8**: The two or more aerosolizers include a first aerosolizer and a second aerosolizer. The pod includes a first container holding a first substance and a second container holding a second substance. The first and second containers are structured to supply the first substance to the first aerosolizer and the second substance to the second aerosolizer. The delivery system according to claim 2. **Claim 9** The first substance includes free-base nicotine, and the second substance includes protonated nicotine. The delivery system according to claim 8. **Claim 10**: The two or more aerosolizers further include a third aerosolizer. The pod further includes a third container holding a third substance. The third container is structured to supply the third substance to the third aerosolizer when the pod is coupled to the delivery device. The delivery system according to claim 8. **Claim 11**: The third substance is a flavoring agent. The delivery system according to claim 10. **Claim 12** The pod has a distal end and a proximal end, an air inlet provided at the distal end and configured to receive air flowing through the channel, a mixing chamber, and an exhaust port at the proximal end for discharging the aerosol mixture from the pod. The delivery system according to claim 2. **Claim 13** The mixing chamber includes an intake opening in fluid communication with the two or more aerosolizers, and the pod is structured such that aerosol generated by the two or more aerosolizers can enter the mixing chamber through the intake opening, mix together, and be delivered from the pod through the exhaust port. The delivery system according to claim 2.

14. The controller circuit further comprises a transceiver, and the controller circuit is configured to receive treatment program information using the transceiver, and the controller circuit is configured to provide a signal for generating an aerosol mixture based on the received treatment program information. The delivery system according to claim 1.

15. The controller circuit is further configured to provide a signal for generating an aerosol mixture having a certain aerosol droplet size from each of the two or more aerosolizers based on the received treatment program information. The delivery system according to claim 14.

16. The controller circuit is configured to provide a signal for generating an aerosol mixture having droplets with a diameter of 1st diameter or less from each of the two or more aerosolizers for the first part of the treatment program based on the received treatment program information, and for the second part of the treatment program, to provide a signal for generating an aerosol mixture having droplets with a diameter of 2nd diameter or more from each of the two or more aerosolizers. The delivery system according to claim 15.

17. The delivery system according to claim 16, wherein the first droplet size is about 1 μm or less.

18. The delivery system according to claim 17, wherein the second droplet size is about 5 μm or more.

19. The delivery system according to claim 17, wherein the second droplet size is about 10 μm or less.

20. The delivery system according to claim 16, wherein the droplet size is at least partially based on a persona profile.

21. The delivery system according to claim 16, wherein the droplet size is at least partially based on a desired deposition location.

22. The delivery system according to claim 16, wherein the hardware controller is further configured to dynamically vary the aerosol generation signal over a period of time. **Claim 23**: The delivery system according to claim 16, wherein the delivery device further comprises a sensor, and the droplet size is at least partially based on sensor information. **Claim 24**: A method for providing an aerosol mixture for a treatment program, comprising: operating and controlling a controller circuit to: provide, to a first aerosolizer driver, an aerosol generation signal for a first aerosolizer to generate an aerosol from a first substance having a first droplet size at a first time and to generate an aerosol from the first substance having a second droplet size different from the first droplet size at a second time, based at least in part on the treatment program stored therein; provide, to a second aerosolizer driver, an aerosol generation signal for a second aerosolizer to generate an aerosol from a second substance having the first droplet size at the first time and to generate an aerosol from the second substance having the second droplet size at the second time, based at least in part on the treatment program stored therein. **Claim 25**: The method according to claim 24, wherein the first droplet size is about 1 μm or less. **Claim 26**: The method according to claim 24, wherein the second droplet size is about 5 μm or more. **Claim 27**: The method according to claim 24, wherein the second droplet size is about 10 μm or less. **Claim 28**: The method according to claim 24, wherein the droplet size is at least partially based on a persona profile. **Claim 29**: The method according to claim 24, wherein the droplet size is at least partially based on a desired deposition location. **Claim 30**: The method according to claim 24, further comprising dynamically changing the aerosol generation signal over a period of time based on the stored treatment program in the controller circuit. **Claim 31**: The method according to claim 24, further comprising causing the controller circuit to generate an aerosol having the first and second droplet sizes based at least in part on sensor information.

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