Modular embedded drug tracking and abuse prevention system

Abstract

A droplet delivery device includes an onboard or externally connected microprocessor-based control system that regulates and gradually reduces a user's drug intake over a specified period of time. A computer application, such as a mobile application of a smartphone or other computing device, monitors usage patterns and delivers controlled doses of the drug, such as nicotine, from the droplet delivery device and enables automated or user-configurable reduction strategies for the drug. The leveraging of real-time data processing and precision control provides an effective tool for managing and reducing drug dependence while maintaining user safety and promoting healthier consumption habits.

Description

MODULAR EMBEDDED DRUG TRACKING AND ABUSE PREVENTION SYSTEMCROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of priority of U.S. Provisional Pat. Application Nos. 63 / 633,521 filed April 12, 2024, 63 / 702,132 filed October 1, 2024, 63 / 735,782 filed December 18, 2024, 63 / 633,136 filed April 12, 2024, and 63 / 701,565 filed September 30, 2024, which are all incorporated herein by reference in their entireties.FIELD OF THE INVENTION

[0002] This disclosure relates to droplet delivery devices and more specifically to tracking and reduction of use of inhalable drugs, such as nicotine, from droplet delivery devices.BACKGROUND OF THE INVENTION

[0003] Industries such as nicotine, pharmaceuticals, and illicit drugs all pose significant risks of abuse and serious health consequences for users. Nicotine is a striking example, responsible for over 10 million premature deaths annually worldwide due to the misuse of cigarettes and other tobacco products. A major contributor to this issue is the lack of monitoring and control over drug delivery methods. Addiction, defined as the inability to regulate one's actions, is exacerbated by the absence of mechanisms to help users manage their consumption beyond sheer willpower. There is a need for a system to reduce the health risks associated with drug abuse and addiction, especially with inhalable drugs. To answer this need, mobile applications and microcontrollers, including a computer processor of a computing device, may be used with droplet delivery devices to track, control and provide reduced use and cessation of drugs administered from droplet delivery devices for inhalation by users.

[0004] U.S. Patent No. 11,793,945 entitled “DROPLET DELIVERY DEVICE WITH PUSH EJECTION,” is incorporated herein by reference in its entirety. In examples, systems and methods for reducing intake of a drug from a droplet delivery device as described herein may be provided with push ejection technology as described in U.S. Patent No. 11,793,945. This disclosure also incorporates herein by reference in its entirety PCT Application No. PCT / US2024 / 035647 entitled “DROPLET DELIVERY DEVICE IMPLEMENTING Al” filed on June 26, 2024. In examples, systems and methods for using artificial intelligence with droplet delivery devices to reduce inhalable drug use may be provided.SUMMARY OF THE INVENTION

[0005] Systems of the invention empower users by tracking their drug intake, providing data- driven recommendations based on patterns observed in other users, and implementingmeasures to restrict usage-such as locking the drug delivery system at predefined intervals. The primary objective of this technology is to help users limit their drug consumption to the minimum necessary to meet their needs. By offering tools to monitor and control intake, the system aims to mitigate the harmful effects of drug abuse and promote healthier, more controlled consumption habits.

[0006] A modular microcontroller system or custom ASIC integrated circuit is included in an electrical drug delivery system to ensure a user intakes the minimal amount of drug to satisfy their needs and ensure their intake does not surpass harmful or lethal levels. The system contains a data communication interface, low power real time clock, flash data to store drug consumption records, and a wireless data communication interface (Bluetooth, RFID, NFC, Zigbee, WIFI, etc.). A record of the time of day and a calculation of the amount of drug that was consumed is recorded to flash memory on every usage of the electronic drug delivery system. The data can then be sent to a mobile phone via a wireless data communication interface wherein a user can view their usage based on a time period (hourly, daily, monthly). The modular drug tracking system can also enable strict age verification and user authentication methods to prevent underage usage.

[0007] A plan to gradually reduce their drug intake over a time period is created to facilitate a minimal drug level to satisfy a user’s needs. The plan is made via a user interface on the phone then sent to the drug delivery system via the wireless interface. The plan is user-specific and can be dynamically adjusted. The drug delivery system can then give real time feedback based on the amount of drug consumed in a certain time period. The system shown in the image below is an example of a system meant to limit a user’s nicotine intake to a desired level which is as low as 0 if a user wanted to quit. In examples, 10 “Puffs” are the nicotine equivalent of one cigarette. Once a user saves the plan, the plan parameters are sent to the drug delivery system so it can give real time feedback. The system described uses green and red LEDs in one example to indicate when the consumer has reached 0-75% (green), 75-99% (yellow), and 100% (red) of their daily intake limit. Once a user has met their limit, a user can either be forced or opted into locking out their drug delivery system where it will not dispense until the limit resets.BRIEF DESCRIPTION OF THE DRAWINGS

[0008] FIG. 1 is a schematic view showing example user interfaces that allow a user to edit parameters pertaining to their drug reduction plan with a droplet delivery device and that show the resulting daily puff target over the course of the plan.

[0009] FIG. 2 is a schematic diagram showing an example of an eight LED user interface on a droplet delivery device using LEDs to notify a user of their daily limit and their current intake of a drug.

[0010] FIG. 3 is a schematic view showing an example user interface on a mobile application that notifies a user of their daily limit and their current intake of drug from a droplet delivery device.

[0011] FIG. 4 is a schematic view showing examples of user interfaces between a droplet delivery device and a mobile phone including a computer processor running a mobile application as a user approaches their daily limit of intake of an inhaled drug.

[0012] FIG. 5 is a schematic view showing an example user interface that increases security by requiring government ID to prevent underage usage of a drug of a droplet delivery device.

[0013] FIG. 6 is a schematic block diagram showing an example of electronic functions that implement a modular drug tracking system.

[0014] FIG. 7 is a schematic block diagram showing an example of a modular drug tracking system.

[0015] FIG. 8A is a schematic block diagram showing an example of structure of user setting data.

[0016] FIG. 8B is a schematic block diagram showing an example of structure of plan setting data.

[0017] FIG. 8C is a schematic block diagram showing an example of structure of last synced data.

[0018] FIG. 8D is a schematic block diagram showing an example of structure of puff history records.

[0019] FIG. 8E is a schematic block diagram showing an example of structure of puff record data.

[0020] FIG. 9 is a schematic block diagram showing an example algorithm to collect and initialize a plan on both the droplet delivery device and mobile application to reduce puffs over time.

[0021] FIG. 10 is a schematic block diagram showing an example algorithm to store and synchronize puff records when the droplet delivery device is connected to the mobile application.

[0022] FIG. 11 is a schematic block diagram showing an example algorithm to prevent underage usage of the droplet delivery device.DETAILED DESCRIPTION

[0023] A reduction plan shown in FIG. 1 gradually reduces a user’s drug intake over time and facilitates a minimal drug delivery to satisfy a user’s needs. The plan is made via a plan edit widget 100 on the phone that allows a user to input their initial drug limit 101, a reduced target drug limit 103, and a target date 105 to get to their reduced target limit drug limit 103. After setting the plan parameters the mobile device will send personalized plan settings 2200 (FIG. 8B) to the droplet delivery device via a communications interface 1400 (FIG. 6). Successful communication of the plan settings 2200 between the droplet delivery device and mobile application (such as running a computer processor of a computing device like a mobile phone or similar personal computing device) enables a user interface on both devices for a user to monitor and limit their drug intake. On the mobile application a user can view a mobile plan interface 102 and the limits for each individual day 104. The calendar interface 102 illustrates the plan in a monthly view where each day limit 104 gets closer to a user’s reduced target drug limit 103.

[0024] Droplet delivery device interface

[0025] Referring to FIG. 2, in one example, the droplet delivery device has an 8 LED interface to show battery life 201 and puff limit 202. Puff limit LEDs 202 illuminate according to the percentage remaining of a user’s limit for the day. The user can see immediate feedback of their limit after every use by monitoring the puff limit LEDs 202. With further reference to FIG. 4, the puff limit LED interface 202 will illuminate all 4 LEDs when a user has 100-75% of their limit unconsumed 402, 3 LEDs with 75-50% puff limit 404, 2 LEDs with 50-25% puff limit 406, 1 LED with 20-0% puff limit 408, then blinking red when a user passes their limit 410

[0026] In other examples, the droplet delivery device has 10 LEDs, 9 LEDs, 7 LEDs, 6 LEDs, 5 LEDs, 4 LEDs, 3 LEDs, 2 LEDs, or 1 LED. The LED interface to a user will change depending on the number of LEDs used on the droplet delivery device.

[0027] Mobile application interface

[0028] In one example, the droplet delivery device connects to a mobile application for a user to view their usage and limits. The mobile interface shows a progress widget 301 to represent a user’s puff limit. As shown in FIG. 3, a user’s current puff count 303 is shown with the daily limit 305 and the fraction is represented with a gas meter progress ring 307. The mobile interface gives a user more precision on their current puff count 303 than the droplet delivery device LEDs 202. With further reference to FIG. 4, each day a user starts with their full allottedpuffs for the day 401, then as a user consumes puffs, they can see as their limit depletes to 75 puffs 403, 50 puffs 405, 25 puffs 407, then 0 puffs 409. The colors of the app can resemble the colors of the devices so when the limit is close to being reached the app is yellow and device LEDs turn to yellow.

[0029] Consumers of many addictive substances have issues with overusing the drugs on an hourly basis as well as a daily basis. An hourly limit can prevent a user from taking too many consecutive dosages, or any consecutive dosages at all. Consecutive dosages of their device can lead to short term health problems such as headache, sore throat, or dizziness. This can be avoided by making the level below that which these health problems arise.

[0030] Overview of modular drug tracking computing device

[0031] Referring to FIG. 6, in one example, a computing system 1000 contains a modular drug tracking computing device (MDTR) 1100 designed to store and communicate user data. The MDTR 1100 is designed to have a processor 1200, memory 1300, communication interface 1400, and a low power timekeeping system 1500. Memory 1300 is split into instructions 1310 and data 1320. The communications interface 1400 consists of a variety of wired (UART, USART, I2C, etc) or wireless (Bluetooth, Zigbee, Wifi, etc.) communication protocols connecting to a variety of networks 1600 of one or more other computing systems. A low power timekeeping system 1500 is designed to keep track of the time with a small amount of power such that a computing system 1000 with low battery can maintain the appropriate time.

[0032] Data

[0033] Referring to FIG. 7 and FIGS. 8A-8E, data 1320 is provided to store user settings 2100, plan settings 2200, last synced data 2300, and puff history 2400. User settings 2100 consist of a variety of user personalized controls. Plan settings 2200 are used to calculate the daily limit 305 on both the droplet delivery device and mobile application. Plan settings 2200 includes an initial puff limit 2210, reduced puff limit 2220, plan length 2230, and a start date 2240. Last synced data 2300 is utilized to display a user’s current puff count 303 with a small amount of flash memory. Last synced data 2300 stores the current daily puff total 2310 and a timestamp 2320. The puff history 2400 section keeps track of data on each inhalation of the device in a puff record 2500 to algorithmically determine the puff equivalence of each inhalation. Puff record 2500 consists of a puff index 2510, puff duration 2520, drug strength 2530, flavor strength 2540, and a timestamp 2550.

[0034] In one example, a “puff’ is a standard measurement of drug usage so a user can view a standard amount of drug they have inhaled. Here the droplet delivery devices may be calibratedto dispense a metered flow of solution depending on the drug strength 2530 and / or flavor strength 2540. A puff equivalence from each individual puff record 2300 can then be calculated through the puff duration 2520, drug strength 2530, and / or flavor strength 2540.

[0035] In another example, a “puff’ is considered an actuation of the device independent of the puff duration 2520, drug strength 2530, and / or flavor strength 2540.

[0036] In another example, a different term than “puff’ is used to convey the drug intake equivalent.

[0037] In another example, a user manually inputs each use. Therefore, the app does not have to be connected to a device and users can use the app to keep track of their usage of any product.

[0038] In one example, the droplet delivery device has many controls to personalize their experience with their device. These settings may be controlled through a mobile application user interface. Daily limit lockout enable 2110 allows a user to lockout their device after the daily limit 305 has been reached. Drug strength 2120 can set the mass ejection rate on a drug solution ejection system. Flavor strength 2130 sets the mass ejection on a flavor solution ejection system. Hourly limit lockout enable 2140 enables a maximum number of puffs per hour to break continuous, habitual use. Hourly puff limit 2150 sets the number of puffs before an hourly lockout occurs which resets every hour.

[0039] Algorithms

[0040] Referring to FIG. 9, in one example, the droplet delivery device is programmed to save puff records to evaluate a user’s dependency on the drug 3100. The mobile application can suggest plan parameters 3200 by giving a recommended initial drug limit 101, reduced target drug limit 103, and time period 105, after receiving the droplet delivery device puff records 2500. The user can then confirm or edit the recommended plan parameters 3300. The mobile application then sends the plan parameters to the droplet delivery device 3400 and verifies the droplet device data 3500.

[0041] In one example, the droplet delivery device is handheld and battery operated. A low- memory, low-cost solution requires a methodical flash memory management system that creates and erases puff records 2500 on the droplet delivery device efficiently. With further reference to FIG. 10, the droplet delivery device is synchronized with the mobile application upon every connection. In this example, the device is programmed to receive a synchronize command 4100 from the mobile application. The droplet delivery device sends all puff records 2500 in the puff history 2400 to the mobile application 4200. The droplet delivery device verifies that the records sent successfully by reading them back from the mobile application’sresponse 4300. The puff total is sent from the mobile application to the droplet delivery device 4400. The device erases its puff history 2400 to conserve data for future puff records 2500.

[0042] With further reference to FIG. 11, in examples where the droplet delivery device is administering age restricted and / or regulated drugs, the droplet delivery device utilizes phone biometric authentication (Face ID, Touch ID, speech recognition, etc.) to ensure the person who bought the device is the person using the device. The process begins with a user buying the droplet delivery device deactivated 5100. The user then registers an account on the app 5200 where one of the steps in the onboarding processes requires a user to upload a picture of their government ID 401. After a user’s account is created, they can activate their device through biometric authentication 5300 which enables the device for a finite amount of time. Once the time has elapsed the droplet delivery device becomes inactive again 5400 and a user can activate the device again through biometric authentication 5300.

[0043] In another example, only one device can be used with one government issued ID and one profile on the app. This limits the number of devices that can be provided to minors. Additionally, the device can disconnect a device, thereby deactivating it. This allows a user to activate a new device. If a user had a new phone, a user’s profile can be switched to a new phone. However, a user’s profile can only be active on one phone at a time.

[0044] Importance of Viewing Standardized Drug Intake Levels

[0045] Consumers can view a standard measurement of their drug intake with a system such as the puff system. The current nicotine industry has many modes of consumption such as cigarettes, e-cigarette devices, non-combusted cigarette devices, patches, sprays, orally consumed nicotine, etc. With these different modes of consumption come different levels of drug efficacy, leading to consumers not having a full understanding of what they are consuming. By standardizing these modes of consumption, consumers will have a better understanding of the effects the drugs have on their body.

[0046] A deeper understanding of the harmful effects of the drugs is obtained through the standardized measurement of drug intake. Accurate records of how much drug was delivered to the consumer can help clinicians understand why the consumer may have developed problems such as heart attacks, strokes, COPD, Cancer, amongst many others. This data is used to discover new recommended limits based on height / weight or previous medical conditions. For example, there is a higher probability of heart attacks when a user consumes over 10 puffs an hour for a sustained period. This information would be impossible to detect using conventional, untracked methods of drug delivery but can be highlighted by an embeddedsystem as described in this document. This potentially vital health information can be easily conveyed to a user through notifications, alerts, etc.

[0047] Having a standardized method of measuring the hourly drug intake of a user may also lead to insights on what actions or times of day trigger a user towards using the drug. These insights are pointed out to a user via the mobile application through notifications. The notifications that describe a user’ s triggers can enable a user to be more aware of their addiction and lead to higher cessation rates.

[0048] A placebo-based system can provide a similar effect to systems that deliver active drugs for directly combating addiction. In this system, a placebo substance is delivered to the lungs, while data is collected on a user’s frequency of use. This approach replicates the sensation and behavioral patterns of prior habits, such as smoking or vaping, without introducing risks of physical addiction or adverse health effects. The placebo-based system may be particularly effective for users who are more challenged by the habitual motions and routines associated with cigarettes, vapes, and similar devices.

[0049] Methods to Facilitate Industry-Wide Adoption of the Technology

[0050] The proposed system leverages existing widely available technologies to enable efficient adoption for drug abuse prevention. For example, a microcontroller family such as the STM32WB series from STMicroelectronics can be integrated into a printed circuit board (PCB) with a compact RF antenna, allowing broad application across electronic drug delivery systems. The STM32WB series features UART / I2C / SPI communication protocols, a low- power real-time clock, flash memory, and a Bluetooth-compatible software stack. These capabilities make it ideal for creating modular, embedded systems designed to prevent drug abuse. Software can be preloaded onto the embedded system, enabling essential functionalities such as dosage record logging and real-time querying of drug intake levels to ensure compliance with predefined thresholds. By providing an off-the-shelf solution, this approach minimizes development time, accelerates industry-wide adoption, and establishes standardized, high-quality systems for electronic drug delivery devices.

[0051] In a market where millions of electronic drug delivery systems are bought and sold annually, developing a custom Application-Specific Integrated Circuit (ASIC) chip can offer a highly cost-effective solution. This custom chip can integrate essential features such as UART / I2C / SPI data communication, flash memory, a low power real-time clock, and Bluetooth peripherals, providing a streamlined and efficient implementation of the system.

[0052] The ASIC or embedded system described is programmed with a set of commands that can link it to a group of independent mobile applications. These mobile applications are differentiated by their targeted drug product and the functions they offer can reflect the risk associated with the different drugs. For example, an addictive substance that is historically available to consumers without a prescription can have an optional lockout feature whereas a prescriptive drug with a high risk of overdose can have a mandatory lockout feature. Another example can be to include a gradual step-down feature for addictive substances like nicotine, opioids, marijuana, or alcohol but not include it for drugs that are less likely to form an addiction like albuterol / ipratropium. This can also be implemented all in the same mobile application which can automatically differentiate the features of the app based on the drug being used. This can also be used for general tracking and information for prescriptive drugs, over the counter drugs, traditional Chinese medicine, etc.

[0053] In another example, a package is provided to attach to current devices on the market, such as a vape. This package attaches to the USB port of the device and is able to record information from the device, such as number and length of shots. Then, this information is trasmitted to the phone and app for tracking.

[0054] Additional Features

[0055] Additionally, using the mobile device’s location allows the use of geofencing. This can eliminate the use of the device on all school premises, child care centers, hospitals, etc. This can be put in place because the device must be in contact with the phone to use. If the location of the phone is within a restricted zone, the device will not administer any dosage.

[0056] Referencing U.S. Prov. Pat. App. Nos. 63 / 633,136, and 63 / 701,565, using RFID will ensure that only legitimate, proper cartridges are used in the device and cartridges cannot be refilled with other substances. Once the cartridge has been used, it will be electronically inactivated. This prevents the use of illicit substances or potentially harmful, uncontrolled e- liquids.

[0057] The rise of generative pre-trained transformers (GPTs) is useful for educating users on the harmful effects of drug abuse pertaining to each drug. For example, a GPT model can easily be trained on scientific research on nicotine abuse, stories from smokers who have had success quitting, and data collected from the embedded system to build convincing evidence that the drug is not something the consumer needs or wants in their life. This information can build to make a GPT that convinces a user to quit or reduce their drug intake by delivering facts based on generally accepted research.

[0058] Diagnostic features are made for the mobile application which can provide a convenient method for diagnosing diseases that are common with the associated drug. For example, people that consume inhaled nicotine commonly get diseases such as COPD. Including a pulmonary function test in the mobile application can encourage users to take the test years before they would have otherwise went to a clinic. Another example can be a carbon monoxide monitor so users can view their carbon monoxide levels go down as they quit nicotine. The embedded circuit may have different versions that are compatible with this diagnostic software. Versions of the embedded include the hardware and software necessary to implement the diagnostic software as well.

[0059] In another example, the app can incorporate artificial intelligence (Al) to tailor the features of the app and device to each user, such as by utilizing systems and methods disclosed in incorporated PCT Application No. PCT / US2024 / 035647 entitled “DROPLET DELIVERY DEVICE IMPLEMENTING AL”

[0060] Benefits of Data Collection

[0061] The combination of the embedded system and the mobile application can produce a standard method of combatting drug abuse for a large variety of commonly abused drugs. Features can be added to the mobile app to optimize reduction and cessation methods to levels that were not previously possible. The effectiveness of these features can be easily analyzed in production through an administrative portal. The analysis of the data can increase reduction / cessation rates, find health issues in various drug delivery devices, and add transparency to manufacturers supplying the drug delivery devices. The analyzation of the data collected from this system enables future improvements and additions to the mobile interface to optimize it towards reduction and cessation of commonly abused drugs. Statistical or Al analysis on the data collected from the mobile application can further improve reduction / cessation rates amongst users and guide towards making design improvements.

[0062] While described with reference to specific examples herein, the invention is intended to extend in scope to the full extent of the disclosure.

[0063] For convenient reference, the following element numbers and corresponding elements are described:

[0064] Table 1

Claims

What is Claimed:

1. An electronic droplet delivery device comprising a data communication connection between the droplet delivery device and a mobile application of a computing device, wherein the mobile application includes one or more interfaces configured for a user to interact with the one or more interfaces to reduce or stop the user’s intake of at least one of an addictive substance the user’s intake of a harmful substance and the user engaging in an addictive behavior.

2. The droplet delivery device of claim 1, wherein the one or more interfaces includes an interface for a user to set his or her initial intake, a reduced target intake, and a target date.

3. The droplet delivery device of claim 2, wherein the one or more interfaces includes an interface for a user to reduce or stop the intake of nicotine.

4. The droplet delivery device of claim 2, wherein the one or more interfaces includes an interface for a user to reduce or stop the intake of nicotine from a cigarette addiction.

5. The droplet delivery device of claim 2, wherein the one or more interfaces includes an interface for a user to reduce or stop the intake of nicotine from a smokeless tobacco addiction.

7. The droplet delivery device of claim 2, further comprising a dispensable placebo.

8. The droplet delivery device of claim 3, wherein the one or more interfaces includes an interface for a user to reduce hand to mouth action associated with using at least one of cigarettes and electronic nicotine devices.

9. The droplet delivery device of claim 2, further comprising a push mode ejector.

10. The droplet delivery device of claim 2, further comprising a ring mode ejector.

11. A droplet delivery device including a display configured to provide feedback to a user inhaling from the droplet delivery device to reduce or stop the user’s intake of one or more ofan addictive substance, the user’s intake of a harmful substance and the user engaging in an addictive behavior.

12. The droplet delivery device of claim 11, further comprising a communication connection to a computer processor, wherein a mobile application is programmed to operate from the computer processor and receive a user setting of his or her initial intake of a drug from the droplet delivery device, a reduced target intake for the drug of the droplet delivery device, and a target date to reach the reduced target intake.

13. The droplet delivery device of claim 12, wherein the drug is nicotine.

14. The droplet delivery device of claim 11, wherein the feedback is to reduce or stop the intake of nicotine from cigarettes.

15. The droplet delivery device of claim 11, wherein the feedback is to reduce or stop the use of smokeless tobacco.

16. The droplet delivery device of claim 11, further comprising a fluid container including a placebo substance.

17. The droplet delivery device of claim 11, wherein the feedback is to reduce or stop hand to mouth action associated with the user using at least one of cigarettes and electronic nicotine devices.

18. The droplet delivery device of claim 11, further comprising a push mode ejector.

19. The droplet delivery device of claim 11, further comprising a ring mode ejector.

20. A computing device with a mobile application running on a microcontroller communicatively connected to a droplet delivery device, wherein the mobile application displays a graphical user interface that receives inputs from a user to reduce or stop one or more of the user’s intake of an addictive substance, the user’s intake of a harmful substance and the user engaging in an addictive behavior and the mobile application at least one of tracks andcontrols the user’s use of the droplet delivery device in comparison to the inputs received from the user.

21. The computing device of claim 20, wherein the inputs received from the user include one or more of a user’s initial intake, a user’s reduced target intake, and a target date for reaching the user’s reduced target intake.

22. The computing device of claim 21, wherein the droplet delivery device includes nicotine.

23. The computing device of claim 20, wherein the mobile application at least one of tracks and controls the user’s use of the droplet delivery device to reduce or stop the use of cigarettes.

24. The computing device of claim 20, wherein the mobile application at least one of tracks and controls the user’s use of the droplet delivery device to reduce or stop the use of smokeless tobacco.

25. The computing device of any of claims 20, wherein the droplet delivery device includes a placebo substance.

26. The computing device of claim 20, wherein the mobile application at least one of tracks and controls the user’s use of the droplet delivery device to reduce or stop hand to mouth action of the user associated with using at least one of cigarettes and electronic nicotine devices.

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