WO2017056103A1 - Système d'administration contrôlée de la nicotine qui restreint et atténue progressivement le dosage - Google Patents

Système d'administration contrôlée de la nicotine qui restreint et atténue progressivement le dosage Download PDF

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Publication number
WO2017056103A1
WO2017056103A1 PCT/IN2016/000236 IN2016000236W WO2017056103A1 WO 2017056103 A1 WO2017056103 A1 WO 2017056103A1 IN 2016000236 W IN2016000236 W IN 2016000236W WO 2017056103 A1 WO2017056103 A1 WO 2017056103A1
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Prior art keywords
nicotine
user
delivery system
cessation
allowance
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PCT/IN2016/000236
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English (en)
Inventor
Anuraag Reddy Kuchukulla
Original Assignee
Anuraag Reddy Kuchukulla
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Publication of WO2017056103A1 publication Critical patent/WO2017056103A1/fr

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/496—Non-condensed piperazines containing further heterocyclic rings, e.g. rifampin, thiothixene
    • A—HUMAN NECESSITIES
    • A24—TOBACCO; CIGARS; CIGARETTES; SIMULATED SMOKING DEVICES; SMOKERS' REQUISITES
    • A24F—SMOKERS' REQUISITES; MATCH BOXES; SIMULATED SMOKING DEVICES
    • A24F40/00—Electrically operated smoking devices; Component parts thereof; Manufacture thereof; Maintenance or testing thereof; Charging means specially adapted therefor
    • A24F40/50—Control or monitoring
    • A—HUMAN NECESSITIES
    • A24—TOBACCO; CIGARS; CIGARETTES; SIMULATED SMOKING DEVICES; SMOKERS' REQUISITES
    • A24F—SMOKERS' REQUISITES; MATCH BOXES; SIMULATED SMOKING DEVICES
    • A24F40/00—Electrically operated smoking devices; Component parts thereof; Manufacture thereof; Maintenance or testing thereof; Charging means specially adapted therefor
    • A24F40/60—Devices with integrated user interfaces
    • A—HUMAN NECESSITIES
    • A24—TOBACCO; CIGARS; CIGARETTES; SIMULATED SMOKING DEVICES; SMOKERS' REQUISITES
    • A24F—SMOKERS' REQUISITES; MATCH BOXES; SIMULATED SMOKING DEVICES
    • A24F40/00—Electrically operated smoking devices; Component parts thereof; Manufacture thereof; Maintenance or testing thereof; Charging means specially adapted therefor
    • A24F40/65—Devices with integrated communication means, e.g. Wi-Fi
    • A—HUMAN NECESSITIES
    • A24—TOBACCO; CIGARS; CIGARETTES; SIMULATED SMOKING DEVICES; SMOKERS' REQUISITES
    • A24F—SMOKERS' REQUISITES; MATCH BOXES; SIMULATED SMOKING DEVICES
    • A24F47/00—Smokers' requisites not otherwise provided for
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M11/00—Sprayers or atomisers specially adapted for therapeutic purposes
    • A61M11/04—Sprayers or atomisers specially adapted for therapeutic purposes operated by the vapour pressure of the liquid to be sprayed or atomised
    • A61M11/041—Sprayers or atomisers specially adapted for therapeutic purposes operated by the vapour pressure of the liquid to be sprayed or atomised using heaters
    • A61M11/042—Sprayers or atomisers specially adapted for therapeutic purposes operated by the vapour pressure of the liquid to be sprayed or atomised using heaters electrical
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M15/00—Inhalators
    • A61M15/0065—Inhalators with dosage or measuring devices
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M15/00—Inhalators
    • A61M15/0065—Inhalators with dosage or measuring devices
    • A61M15/0068—Indicating or counting the number of dispensed doses or of remaining doses
    • A61M15/0081—Locking means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M15/00—Inhalators
    • A61M15/0065—Inhalators with dosage or measuring devices
    • A61M15/0068—Indicating or counting the number of dispensed doses or of remaining doses
    • A61M15/0083—Timers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M15/00—Inhalators
    • A61M15/06—Inhaling appliances shaped like cigars, cigarettes or pipes
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H20/00—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance
    • G16H20/10—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to drugs or medications, e.g. for ensuring correct administration to patients
    • G16H20/13—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to drugs or medications, e.g. for ensuring correct administration to patients delivered from dispensers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/0003—Accessories therefor, e.g. sensors, vibrators, negative pressure
    • A61M2016/0015—Accessories therefor, e.g. sensors, vibrators, negative pressure inhalation detectors
    • A61M2016/0018—Accessories therefor, e.g. sensors, vibrators, negative pressure inhalation detectors electrical
    • A61M2016/0021—Accessories therefor, e.g. sensors, vibrators, negative pressure inhalation detectors electrical with a proportional output signal, e.g. from a thermistor
    • A—HUMAN NECESSITIES
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    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/13—General characteristics of the apparatus with means for the detection of operative contact with patient, e.g. lip sensor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/35—Communication
    • A61M2205/3546—Range
    • A61M2205/3553—Range remote, e.g. between patient's home and doctor's office
    • A—HUMAN NECESSITIES
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    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/35—Communication
    • A61M2205/3546—Range
    • A61M2205/3569—Range sublocal, e.g. between console and disposable
    • A—HUMAN NECESSITIES
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    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/35—Communication
    • A61M2205/3576—Communication with non implanted data transmission devices, e.g. using external transmitter or receiver
    • A61M2205/3584—Communication with non implanted data transmission devices, e.g. using external transmitter or receiver using modem, internet or bluetooth
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/35—Communication
    • A61M2205/3576—Communication with non implanted data transmission devices, e.g. using external transmitter or receiver
    • A61M2205/3592—Communication with non implanted data transmission devices, e.g. using external transmitter or receiver using telemetric means, e.g. radio or optical transmission
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/50—General characteristics of the apparatus with microprocessors or computers
    • A61M2205/502—User interfaces, e.g. screens or keyboards
    • A61M2205/505—Touch-screens; Virtual keyboard or keypads; Virtual buttons; Soft keys; Mouse touches
    • A—HUMAN NECESSITIES
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    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/50—General characteristics of the apparatus with microprocessors or computers
    • A61M2205/52—General characteristics of the apparatus with microprocessors or computers with memories providing a history of measured variating parameters of apparatus or patient
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/58—Means for facilitating use, e.g. by people with impaired vision
    • A61M2205/582—Means for facilitating use, e.g. by people with impaired vision by tactile feedback
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    • A61M2205/00—General characteristics of the apparatus
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    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/82—Internal energy supply devices
    • A61M2205/8206—Internal energy supply devices battery-operated
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    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/82—Internal energy supply devices
    • A61M2205/8237—Charging means

Definitions

  • the invention relates to a system for delivering nicotine and managing the user's nicotine dependence, and more specifically relates to a controlled nicotine delivery system which restricts, and gradually attenuates the dosage.
  • Tobacco smoking is the most common method of consuming tobacco and is widely practiced globally. Tobacco smoking is associated with a variety of health risks including Lung Cancer. Various scientific and medical studies have confirmed that Tar and Carbon mono-oxide (CO) which form a major component of the smoke inhaled are the root cause of the aforementioned health risks. Tobacco smoking claims millions of lives worldwide and has become a major cause of concern globally. Its ill-effects are found to affect not just those who actively engage in smoking but also those who inhale the smoke passively.
  • CO Carbon mono-oxide
  • Nicotine is a highly addictive substance found in tobacco and variety of alternatives such as chewing tobacco and nicotine based chewing gums are available for addicts who seek an alternative to smoking but such alternatives have not been found to be successful as they take a longer time to take effect. They must first be absorbed through the digestive tract before the nicotine reaches the bloodstream. Despite the dangers, smoking still finds favour as the smoke is directly inhaled and the nicotine is directly absorbed into the bloodstream and affects the brain with a relatively shorter time lag. [5] To overcome the shortcomings of traditional tobacco smoking practices which involve a controlled combustion of processed tobacco, electronic cigarettes were developed which eliminate the harmful carcinogenic by-products of combustion including tar and carbon monoxide and deliver nicotine, the addictive substance within tobacco directly upon inhaling.
  • a further objective of the invention is to provide a nicotine delivery system which accepts parameters including but not limited to the nicotine dosage, the number of doses over a specified time interval, the time interval between two consequent doses and the time period over which the de-addiction is sought to be achieved, from the user.
  • a further objective of the invention is to provide the various components necessary to deliver and restrict the said dosage into the user's body without the ill- effects and risks associated with traditional tobacco smoking.
  • Yet another objective of the invention is to generate a de-addiction programme from the inputs received from the user, and ensure that once operational, the de- addiction programme cannot be tempered with by the user until such time as the entire programme is successfully completed.
  • the present invention provides a controlled nicotine delivery system comprising an electronic vaporizing apparatus; a nicotine fluid tank; a primary processing device being programmed with a nicotine cessation plan which accepts a target smoking cessation duration, number of cigarettes consumed in a day and nicotine per cigarette as inputs and outputs a refill rate, a refill limit and an attenuation factor and operates the electronic vaporizing apparatus in an Allowance Session releases a predetermined maximum dosage of nicotine followed by a Prohibition Interval; the Prohibition Interval being inversely proportional of an attenuating refill rate. The allowance time being proportional to the refill limit. The attenuation factor being proportional to the cessation duration.
  • the nicotine cessation plan is programmed in the nicotine delivery system's primary processing device.
  • the nicotine cessation plan is designed to be an extrinsic management system to which the user can delegate control over his consumption of nicotine and thus bypass the addict's inadequate intrinsic self-control faculties to overcome the addiction.
  • Addiction is the accumulation of self-destructive habits that seek sources of reward. All habit patterns involve cues which trigger a certain behaviour which rewards the pleasure centres of the brain. It is the objective of the program to decouple the existing social, intrinsic neurochemical cues from the pleasure seeking behaviour while reducing the physical dependence on the substance over a reasonable period of time to avoid severe withdrawal and discouragement.
  • the nicotine cessation plan takes into account all of these factors in addition to many others, to create and administer a personalised plan which addresses each of the causes of a relapse. Expecting the smoker to quit overnight is impractical given the fact that nicotine addiction is a neurochemical dependency and a sudden decrease of nicotine levels in the blood leads to withdrawal symptoms. To ensure that the withdrawal symptoms are avoided, the nicotine cessation plan as per the present invention aims at reducing the nicotine dosage over the user's target cessation duration. Further, the nicotine cessation plan delivers nicotine to the user in timed intervals called “Allowance Sessions" which are spaced out by intervals during which the user is not allowed to consumer nicotine, called “Prohibition Intervals". These timed intervals are administered in the form of two phases, an unlocked phase when the user may avail an Allowance session and a locked phase where the user is administered a Prohibition Interval, respectively.
  • the plan is configured to take into account the users smoking practices at the time when the user intends to commence the nicotine cessation plan administered by the nicotine delivery system. This helps establish a baseline of the levels of nicotine consumed by the user and the intended date of cessation, accordingly a customised program is calculated and administered to the user by the system. This also helps monitor the user's progress over time and to suggest actionable intelligence to the user through analysis of data generated and collected over the target cessation duration.
  • the user may only avail a predetermined nicotine dosage during an Allowance Session when the electronic nicotine vaporiser .is unlocked.
  • the quantity of nicotine delivered to the user during this Allowance Session which is available after the electronic vaporising apparatus is unlocked is equal to the quantity of nicotine from smoking a single cigarette.
  • the device is locked.
  • the duration of the locked phase is designed to administer a Prohibition Interval between two Allowance Sessions. This is done by creating a dynamic variable called "Allowance Time".
  • An Allowance Time is the cumulative of the time period for which the heating coil will be allowed to be turned ON during the administration of the nicotine cessation plan by the nicotine delivery system.
  • the Allowance Time is configured to increase with time up to a limit called "Refill Limit".
  • the electronic vaporising apparatus unlocks and an Allowance Session becomes available to the user.
  • the rate at which the Allowance Time increases is called a "Refill Rate".
  • a lower Refill Rate will increase the Allowance Time at a lower rate therefore locking the electronic vaporising apparatus for longer. The longer it is locked, the longer the user has to wait for it to unlock and as a consequence the user is administered a longer Prohibition Interval.
  • the electronic vaporising apparatus unlocks with an Allowance Time equal to the Refill Limit. Once the user exhausts the present Allowance Time, the Allowance Session is terminated and the electronic vaporising apparatus locks up again, thereby initiating another Prohibition interval.
  • Refill Rate is readjusted in an attenuating manner. This is done by multiplying the Refill Rate by an "Attenuating Factor.”
  • the Attenuating Factor is an integer less than 1 and is a function of the target cessation duration. It approaches 1 when the target cessation duration is longer and vice-versa.
  • an application running on a secondary processing and communication device with a graphical user interface and radio link accepts the user's smoking details including, the number of cigarettes smoked, the quantity of nicotine present in each of those cigarettes and the target cessation duration. This information is the basis for the nicotine cessation plan to administer an attenuating nicotine dosage over the target duration to the user.
  • the application computes a "Refill Rate", an "Attenuation Factor” and a "Refill Limit”. These values are used to compute the time duration of an Allowance Session and calculate the allowance time and the duration of the Prohibition Interval, during which the electrdnic vaporing device is locked, as per the nicotine cessation plan configured by the user, also described above.
  • the nicotine cessation plan may also advantageously be configured on a plurality of processing devices, for example a part of the nicotine cessation plan may be configured on a processing device of a secondary processing and communication device, such as a smart phone, in the form of an application installed in it. At least a part of the computations necessary for the execution of the nicotine cessation plan may be executed by the processing device of the secondary processing and communication device, for example a smart phone. Further for example, the smart phone may be configured to accept the inputs necessary for configuring the nicotine cessation plan administered by the nicotine delivery system and the computations including that of Refill Rate, Attenuation Factor, Allowance Time and Refill Limit etc. may be advantageously performed on the secondary processing and communication device such as a smart phone.
  • the secondary processing and communication device may be paired with the nicotine delivery system through a communication device provided in the nicotine delivery system. The system and the secondary processing and communication device may communicate with each other, preferably over a radio link using a Bluetooth low energy radio.
  • the input information may either directly be accepted by the primary processing device of the system or may be accepted through a graphical user interface created for the secondary processing and communication device, for example a smart phone.
  • the user may conveniently set and monitor the nicotine cessation plan administered by the nicotine delivery system through his smart phone.
  • the nicotine delivery system in addition to being capable of communicating with a plurality of devices is further capable of connecting to the internet so the user may create personal accounts ⁇ share progress with social connections. Save progress on the cloud.
  • the nicotine cessation plan administered by the nicotine delivery system is provided with a "Training mode".
  • Training mode a user may simply use the nicotine delivery system as a normal cigarette.
  • the nicotine delivery system is not restricted in terms of the Allowance Sessions and Prohibition Intervals and is not locked on to a fixed plan.
  • the nicotine cessation plan over the time during which the user uses the nicotine delivery system in the training mode, monitors and trains itself to analyse the user's nicotine addiction levels and smoking patters. Based on such analysis, the nicotine cessation plan populates the inputs which otherwise would have been accepted from the user. These inputs are then. configured into the plan and a personalised nicotine cessation plan is then administered to the user.
  • the user may feel sudden and severe cravings when following the nicotine cessation plan administered by the nicotine delivery system. In such a condition, there is a non-trivial chance that the user may bypass the nicotine delivery system to satisfy his cravings by lighting a cigarette. Such a condition is undesirable as it may further lead to a relapse into smoking cigarettes.
  • the nicotine cessation plan as administered by the nicotine delivery system has a special provision whereby the user may manually unlock without having to wait for the device to unlock on its own.
  • the application running on the secondary processing and communication device is provided with an "Unlock Cigarette" feature.
  • This "Unlock Cigarette" feature allows the user to manually unlock. However, the duration of the allowance would be shorter and be limited to the Allowance Time computed at that time. For example, if the allowance time is 2 minutes short of the Refill Limit, and the user demands a special Allowance Session, such a session will last only for as long as the Allowance Time accumulated until that point by the Refill process, which will be less than the Refill Limit.
  • the interface may be configured to seek confirmation, delay or distract the user from impulsively unlocking the electronic vaporising apparatus.
  • a further feature of this invention is the "Quit Faster” and “Quit Slower” settings available to the user. Having initiated a custom nicotine cessation plan, if the user is oft the opinion that the pace of progress needs readjustment, the same may be given effect by selecting a "Quit Faster” or “Quit Slower” option. These options recalibrate the Attenuation Factor. After the readjustment, the target cessation duration either increases or decreases, depending on the option selected. [28] It is further noticed that users after having abstained from smoking for an extended period of time, for after a night's sleep, have a sharp fall in their blood nicotine level.
  • the nicotine cessation plan administered by the nicotine delivery system has a "Sleep Compensation" feature which ensures that the user is given a marginally higher dosage when the user has abstained from smoking for a considerably longer period of time such as when asleep.
  • the time period after which the system releases a compensatory higher dosage is 6 hours.
  • the nicotine delivery system comprises of a primary processing device, a memory storage unit a communications device, a power source, an electronic vaporizing apparatus, a nicotine storage tank, a charging circuit, a vibrating motor, a physical button and a multi-colour light source and a secondary processing and communications device configured to interact with the primary processing device of the system.
  • the system may also conveniently be configured to dispense a dosage as per the plan being administered to the user simply by the act of inhalation from the electronic vaporising apparatus.
  • the electronic vaporising apparatus may employ suitable sensors including touch sensors placed on the outlet of the electronic vaporising apparatus to sense the user's mouth or a barometric pressure sensor to sense the pressure difference caused in the outlet of the electronic vaporising apparatus caused due to the inhaling of the user or a combination thereof.
  • Other components may also conveniently be used in addition to the aforesaid.
  • the nicotine cessation plan programmed in the primary processing device of the nicotine delivery system controls the nicotine vaporizing apparatus to heat the coil in order to release nicotine vapours at a standardised nicotine flow rate. These vapours are then inhaled by the user during an unlocked phase.
  • Notifications are generated as extrinsic cues and may be communicated to the user through the secondary processing and communication device or through a vibrating motor.
  • the vibrating motor may be configured to vibrate in distinct patterns with a specific meaning assigned to each pattern, and cue the user. This also helps create a competing cue for seeking nicotine and overcome or replace the conventional cues that trigger nicotine or cigarette seeking behaviours.
  • SHORT DESCRIPTION OF DRAWINGS [31] Figure 1 illustrates a controlled nicotine delivery system as per one embodiment of the present invention.
  • Figure 2 illustrates a block diagram of an embodiment of the present invention.
  • Figure 3A illustrates a user interface created as per one embodiment of the present invention to accept the user's current daily cigarette consumption as an input for the system from a secondary processing and communication device.
  • Figure 3B illustrates a user interface created as per one embodiment of the present invention to accept the nicotine content of each cigarette as an input for the system from a secondary processing and communication device.
  • Figure 3C illustrates a user interface created as per one embodiment of the present invention to accept a target date by which the user intends to quit smoking, as an input for the system from a secondary processing and communication device.
  • Figure 3D illustrates various aspects of a user interface created as per one embodiment of the present invention to communicate information regarding the Allowance Session and Prohibition Interval as per the configured nicotine cessation plan.
  • Figure 3E illustrate a user interface created as per one embodiment of the present invention to communicate and display an overview of the nicotine cessation plan.
  • Figure 3F illustrate various aspects of a user interface created as per one embodiment of the present invention to communicate various notifications to the user from a secondary processing and communication device.
  • Figure 3G illustrate a user interface created as per one embodiment of the present invention to make changes to the nicotine cessation plan program.
  • Figure 3H illustrate a user interface created as per one embodiment of the present invention to communicate the systems hardware details including battery related to the user.
  • Figure 4 illustrates a flowchart for the initialisation of the system when the device is turned on according to one embodiment of the present invention.
  • Figure 5 flowchart for accepting inputs from the user and configuring a nicotine cessation plan based on accepted inputs as per one embodiment of the present invention.
  • Figure 6 illustrates a flowchart for implementing the nicotine cessation plan through the controlled nicotine delivery system according to an embodiment of the present invention.
  • FIG. 1 shows a controlled nicotine delivery system 5 which has an electronic vaporizing apparatus 85 and a power and control unit 90.
  • the electronic vaporising apparatus 85 comprises of a heating coil 10 which draws the fluid stored in the fluid tank 20 through wicks 15.
  • the electronic vaporizing apparatus 85 has an outlet 7 from which the user may inhale the vapours.
  • the outlet 7 is conveniently tapered such as to suitably fit inside the user's mouth.
  • the outlet may also conveniently be provided with sensors including a pressure sensor to sense the pressure differential caused due to the user inhaling from it and a touch sensor to sense the user's application of the outlet 7 to the mouth or a combination thereof. Both these serve to automate the process of nicotine delivery without the user having to switch ON/OFF the button 35.
  • the fluid tank 20 contains nicotine fluid of a preferably standardised concentration inside it.
  • the wicks 15 are immersed in the nicotine fluid and are ' operationally connected to the heating coil 10 and supply nicotine fluid to the heating coil at a steady rate.
  • the heating coil 10 vaporises the nicotine fluid, at a preferably constant rate of nicotine flow, for example 0.02 mg per second.
  • the rate of vaporisation depends on the electrical resistance of the heating coil material, the current drawn by the heating coil 10 and the duration for which the coil is operated. A desired constant nicotine flow rate can be attained by adjusting the parameters suit the requirements.
  • the fluid tank 20 itself is detachably connected to the heating coil 10. It may be replaced with another fluid tank when the nicotine fluid is consumed or may be conveniently refilled.
  • the power and control unit 90 has a housing 60 which accommodates the power and control circuitry.
  • the housing 60 encloses a printed circuit board hereinafter referred to as PCB 80.
  • the PCB 80 has a processing device 45, a communication device 40, a light source in the form of a light emitting diode hereinafter referred to as LED 30, a vibrating motor 37, and an ON/OFF button 35.
  • the electronic components are all powered by a rechargeable battery 55.
  • Battery terminals 65 and 70 are provided on the PCB 80 and the battery 55 is disposed between these terminals. This arrangement provides power to the nicotine delivery system whilst at the same time allowing for the battery pack to be replaced by simply disconnecting it from the terminals 65 and 70.
  • the PCB 80 has a charging circuit 50 which draws external power to charge the rechargeable battery 55.
  • the charging circuit 50 advantageously also has a protection circuit which protects the vaporising apparatus 85 and power and control unit 90 from accidentally shorting, voltage fluctuations during operation in addition to protecting the battery from overcharging and being discharged completely.
  • the housing 60 is conveniently designed with suitable openings (not shown) to allow for the switch 35 and the LED 30 to be accessible to the user from the outside and also to ensure that the battery 55 is replaceable.
  • the housing 60 is preferably provided with suitable attaching arrangement so that it may be detachably connected to the electronic vaporising apparatus 85 via a connector 25.
  • the connector also has suitable wiring (not shown) to connect the vaporising apparatus to the power and control unit 90 so that the heating coil 10 may conveniently draw power and be controlled by the processing device 45.
  • the electronic vaporising apparatus 85 may be detached from the power and control unit 90 from the connector 25. Additionally the vaporising apparatus 85 may also be integrated along with the power and control unit 90 into a unibody arrangement.
  • the processing device 45 is preferably a programmable microcontroller with an EEPROM/Flash/Static memory and the communication device 40 is preferably a Bluetooth low energy radio circuit, but other suitable components may also be conveniently employed.
  • FIG. 2 a block diagram of the controlled nicotine delivery system as per one embodiment of the invention is illustrated.
  • the diagram represents information flow and decision making between the electronic vaporising apparatus, the power and control unit and the user.
  • the system accepts inputs from the user throug a secondary processing and communication device as an input medium.
  • a smart phone is one such example of the secondary processing and communication device.
  • the smart phone has a part of the nicotine cessation plan installed on it in the form of an application.
  • the primary processing device preferably a microcontroller
  • the microcontroller is preferably with an EEPROM/Flash/Static memory which is used to store information requisite for the operation of the nicotine delivery system.
  • the microcontroller locks or unlocks the electronic vaporising apparatus comprising the heating coil and the fluid tank by operation through a transistor based coil driver. Such operation is subject to the nicotine cessation plan being administered by the nicotine delivery system.
  • the microcontroller also notifies the user of such locking or unlocking as the case may be, through a vibration produced by the vibrating motor. For example, in case where the device is unlocked for the user, the user is notified about the unlock event either through a notification over the smart phone or through a vibration pattern, or through the indicator LED or a combination thereof.
  • the vibrating motor may also be configured to communicate notifications to the user in various forms and patterns and a specific meaning can be attributed to each of the plurality of patterns in which it can be made to vibrate.
  • the user may now inhale the nicotine vapour by activating the heating coil by turning on the manual switch or through a plurality of activation sensors for example a barometric sensor.
  • the micro-controller controls the LED to communicate basic information about the status of the system including battery status lock/unlock status etc. and may be further configured to communicate such information as the user may choose.
  • the indicator LED can be configured to be lit up in various colors and patterns with a specific meaning can be attributed to each of the plurality of patterns in which the light may be made to light up.
  • the system is powered by a power block as illustrated by the block diagram.
  • the power block has a power source in the form of a rechargeable battery. It is also provided with a battery charging and protection circuit in addition to a low dropout voltage regulator which the former ensures the safe charge and discharge of the battery and the later drops the voltage to operating voltage of the processing circuit.
  • the status of the battery in addition to details such as battery health etc.
  • the aging of the coil can be measured and be communicated to the user.
  • Figures 3A to 3H illustrate the graphical user interface provided on the secondary processing and communication device which facilitates the ease of operation of the device by the user.
  • the user may use a variety of devices as an input medium by simply running the application bundled with the system 5 on the device of choice, such as a smart phone. Once the graphical user interface is in place, the user is prompted to enter details about the nicotine cessation plan.
  • the nicotine cessation plan administered by the nicotine delivery system 5 through the graphical user interface on the smart phone accepts information including the number of cigarettes smoked by the user in a day and the quantity of nicotine in each of those cigarettes to ascertain a daily nicotine consumption of the user.
  • the interface as illustrated in Figure 3B has a drop down menu which hosts a plurality of cigarette brands available in the market. The user may simply enter the number of cigarettes smoked per day and choose his brand from the drop down menu and the system ascertains the user's daily nicotine consumption.
  • the system then accepts a target duration within which the user intends to quit smoking as illustrated in Figure 3C.
  • This target date can be any future date on the calendar and the system uses the daily nicotine consumption value and the target date by which the user intends to cease smoking, to compute, set and display, the quantity of nicotine the user is allowed to consume in a single session hereinafter referred to as an "Allowance Session".
  • the system also computes sets and displays the time duration for which the user is not allowed to smoke after having completed the Allowance Session. This time duration is hereinafter referred to as the "Prohibition Interval".
  • the Prohibition Interval is displayed in the form of a countdown timer which the user may track to know when the system will allow for another Allowance Session.
  • the user interface for the same is illustrated in Figure 3D.
  • the nicotine delivery system 5 also gathers and generates intelligence.
  • This intelligence is organised and displayed in a user friendly manner in the form of simple charts and notifications as illustrated in Figure 3E. Based on the intelligence provided, if the user is unsatisfied with the pace of the progress, he may recalibrate the pace through the interface itself by using either of the "Quit faster” or “Quit slower” options on the user interface. Selecting the "Quit faster” option increases the attenuation factor as a consequence of which the nicotine dosage is progressively decreased more rapidly. The user therefore quits in a time span shorter than the previously configured target smoking cessation duration.
  • the system recalibrates the attenuation factor to reduce the rate of attenuation of the nicotine in each successive Allowance Session.
  • the Attenuating Factor is an integer less than 1 and is a function of the target cessation duration. It approaches 1 when the target cessation duration is longer and vice-versa. As a consequence the user's target smoking cessation duration is extended further and to such effect, the nicotine cessation plan is recalibrated.
  • the present invention also generates interactive notification and communicated them to the user via the smartphone user interface or the vibrating motor 37 which may be conveniently made to vibrate in a plurality of patterns and each of the patterns may be attributed to a specific information being communicated. For example when the Prohibition Interval has elapsed, the system may notify the user of the event either through a notification on the smart phone or through a certain pattern of vibration or lighting of the LED or a combination thereof. This interface is illustrated in figure 3F. [61] Further, referring to Figures 3G and 3H, the system offers a simple and interactive graphical user interface for the user to make changes to the settings of the controlled nicotine delivery system 5.
  • the user may set Training Sessions so that the system records and recognises smoking patterns of the user and further insights may be uncovered by running further data analysis. This is especially advantageous when the user desirous of undertaking the nicotine cessation plan administered by the nicotine delivery system 5 is unaware of his extent of addiction and smoking patterns. In such a case the user may find it hard to configure the optimum plan for him. So being the case, when the user activates the Training mode, the nicotine cessation plan administered by the nicotine delivery system allows the user to smoke from the system as though he would from an ordinary cigarette. There nicotine cessation is not administered to the user and instead the system 5 tracks and analyses the users smoking habits to ascertain details including a daily nicotine consumption. This information is then used to configure a personalised nicotine cessation plan for the user and the same is administered to the user over target cessation duration as chosen by the user.
  • the system also allows the user to restart the nicotine cessation plan if he so desires and the user will be taken back to the configuration process as discussed above.
  • Battery status may be checked and when the battery is running low on charge a charging reminders may also be set through the user interface. Further the system allows the user to pair a plurality of devices such as smartphones or tablets with the system and the user may synchronise the data and progress of the nicotine cessation plan over a plurality of devices and remain connected seamlessly.
  • the habit of smoking has many triggers including social, psychological and neurochemical cues.
  • the use of the vibrating motor 37 is done to create a competing habit cue. This helps create a new cue of a unique vibrating pattern for the same routine of seeking and consuming nicotine. This pattern may be attributed to the electronic vaporising apparatus 85 being unlocked and an Allowance Session becoming available to the user.
  • the user's brain will overtime associate the pattern of vibration with the availability of nicotine and over the course of the program the cues will be spread apart farther in time and the user will have fewer urges with fewer and rarer unlocking events.
  • FIG. 4 illustrates the flowchart of system initialisation which occurs when the system is turned on by the user by pressing the activation button 35 which also acts as an ON button if the device wasn't already ON.
  • the button 35 When the button 35 is turned on, the system draws power from the battery 55 and the primary processing device 45 loads program variables from its static memory. Having concluded this operation, the system initialises the communication device 40, for example the Bluetooth radio. Upon both the primary processing device 45 and communication device 40 being initiated, the system enters a Sleep mode to conserve energy and returns to its operating state subject to user command to such effect.
  • FIG. 5 is a flowchart which depicts the process by which the system when turned on by the user, checks if the system is connected to the users smart phone. If the smartphone is not found to be connected to the system 5 via the radio link, the primary processing device 45 pairs with the smartphone through the Bluetooth low energy radio communication device 40. Upon successful pairing of the system 5 with the user's smartphone the primary processing device 45 checks to find if the nicotine cessation plan is configured in the program.
  • the primary processing device 45 considers two possible scenarios. Firstly when the user is configuring the plan for the first time, wherein the system accepts users daily cigarette consumption and nicotine per cigarettes to ascertain the user's daily nicotine consumption.
  • the processor 45 executes the request by aborting the previous plan and accepting new values of the user's daily nicotine consumption and a new target smoking cessation duration within which the user intends to cease smoking.
  • the system uses a pre-programmed nicotine flow rate of the heating coil 10 using techniques to ascertain flow rates well known in the art and stores the value as "Nicotine Flow Rate" in its memory.
  • the secondary processing device then computes a "Refill Limit” which is directly proportional to the nicotine per cigarette smoked by the user and inversely proportional to the "Nicotine Flow Rate" of the heating coil 10.
  • the value is stored as “Refill Limit” for further use in computation.
  • the Refill Limit is expressed by the following mathematical equation.
  • Refill Limit nicotine per cigarette / nicotine flow rate.
  • the secondary processing device then computes a refill rate which is directly proportional to the product of the number of cigarettes per day and nicotine per cigarette value and is inversely proportional to the nicotine flow rate.
  • This refill rate is refill quantity per unit time (in seconds).
  • the system 5 adjusts the rate of nicotine delivery by compensating for the period the user doesn't consume, for example while sleeping.
  • the duration of the compensation is adjustable. Sleep compensation is the computed by changing the number of seconds in a day by the hours of sleep compensation to get a "Refill Rate". This value is stored as "Refill Rate" for further use in computation
  • the Refill Rate is expressed mathematically as follows:
  • Refill Rate ((Cigarettes per day * Nicotine per cigarette)/nicotine flow rate)/ (seconds in a day - sleep compensation time in seconds)
  • the processing device 45 computes a factor by which the refill rate is to be reduced so as to attenuate the nicotine dosage delivered to the user by the system over the duration of the cessation plan.
  • T is the total duration of the plan (in days).
  • N is the attenuations performed per day.
  • ATL is addiction threshold limit, the dosage limit below which the user has overcome his addiction.
  • TDNC is the total daily nicotine consumption of the user at the time of configuring the system. Which is the product of Nicotine per cigarette, and cigarettes per day.
  • Attenuation per day is the number of times the dosage is attenuated over the course of 24 hours. If the number is set to be lower, the consequence is that the user has a noticeable drop of nicotine after each consecutive Allowance Session. A drastic drop in the nicotine dosage is undesirable since it increases the chances of a craving. Therefore it is attenuated a fixed number of times over a day, so as to give the user a smooth and unnoticeable transition in each successive nicotine dosage for an Allowance Session.
  • secondary processing device communicates the values of "Refill Limit”, "Refill Rate” and "Attenuation Factor” to the processing device 45 via a radio link through the Bluetooth low radio communication device 40.
  • the computation is advantageously performed by the smartphone so that the computational load on the processing device 45 is reduced. This allows the use of a processing device of a lower capacity, thereby reducing cost of the system. It may be noted that the computations performed by the smartphone can also conveniently be performed by the processing device 45.
  • the smartphone is advantageous for it Graphical User Interface/ and its ability to communicate complex information of the user's progress, devices operation and functions to the user through such an interface. It also can connect to the internet so the user may create a personal account, share progress with social connections. Save progress on the cloud and transfer information to another such device. [75] Now the execution of the nicotine cessation plan, configured as per the user's requirements through the process as explained above, is described. The functioning of the nicotine cessation plan may further be understood with reference to the flowchart illustrated in Figure 6.
  • the nicotine cessation plan is desirably programmed into the processing device 45.
  • the processing device 45 accepts all the information necessary for the execution of the plan.
  • the processing device 45 executes the plan in the form of a loop of decision making. Between any two cycles of the loop being run by the processing device 45, the system is put into a state of sleep in order to conserve energy when the system 5 is not in use. After every predetermined interval of time, the processing device 45 wakes to perform a series of evaluations to check if an attenuation to the nicotine dosage is due. If attenuation is found to be due, the processing device 45 performs the attenuation by readjusting the refill rate of the system.
  • step S1 the processing device 45 wakes and performs step S2 where the device 45 checks if the time since the last instance of performing attenuation has passed beyond a predetermined threshold period. If step S2 is found to be true, the processing device 45 performs step S3 in which the refill rate is attenuated by multiplying the refill rate by an attenuation factor and stores this value as the new refill rate,
  • step S4 the device 45 performs step S4 to check if the time since last interaction of the user with the system 5 has exceeded a predetermined threshold, called the interaction timeout. If the time since last interaction of the user with the system 5 is found to be exceeding the interaction time out value, in step S5 the system 5 ends the Allowance Session and initiates a Prohibition Interval thereby essentially locking the electronic vaporising device 85.
  • the threshold interaction timeout may be a suitable time frame for example, if the user does not reactivate within 10 minutes after being deliberately activated after unlocking, the system 5 terminates the session and initiates a Prohibition Interval so that the allowance session don't extend indefinitely.
  • step S6 the processing device 45 stores the event or consumption details in its memory and updates the program to indicate the end of an Allowance Session.
  • step S7 the processing device 45 computes the allowance by multiplying the time since a previous refill with the refill rate. The allowance increases as time passes but will become available to the user in the form of an Allowance Session only when the allowance reaches the refill limit.
  • step S8 the processing device 45 checks if the allowance has exceeded the refill limit and when the condition is reached, the processing device 45 performs step S9 wherein the allowance is assigned the value equal to the refill limit. This is a condition sufficient for the user to be able to avail a fresh Allowance Session and the device 45 performs step S10 to notify the user of the availability of a fresh Allowance Session by turning on the vibrating motor 37 for a pre-set duration, for example for 1 second.
  • the processing device 45 in step S11 unlocks the electronic vaporising apparatus 85 so that the user may avail the fresh Allowance Session.
  • step SI 2 The processing device 45 checks for this condition in step SI 2. If in this step the condition is found to be satisfied, the processing device 45 proceeds to step S15 to check if the button 35 is still pressed and that the electronic vaporising device 85 is not in a locked state. This indicates that the user has an Allowance Session at his disposal and wishes to avail it by pressing the button 35. When the condition in step S15 is found to be satisfied, the processing device 45 in step 16 switches ON the heating coil 10 and vaporised nicotine is delivered to the user.
  • the device 45 performs steps S13 and S14 to terminate the Allowance Session and initiates a Prohibition Interval, thereby locking the electronic vaporising device 85 and stores the event as an end of the Allowance Session in its memory for future computation.
  • the device 45 then performs S15 as described above and oh finding that the electronic vaporising device 85 is locked, i.e. in a Prohibition Interval, the processing device 45 performs step S17 to check the ON/OFF state of the button 35.
  • step S17 Subject to the status of the button 35 as ascertained in step S17, if the button 35 is found to be in an OFF state, the processing device 45 switches off the heating coil 10 which was turned on in step S 16 and in step S19 and S20 updates the new allowance after the Allowance Session by subtracting the time duration for which the user availed the Allowance Session from the total allowance available at the start of the fresh Allowance Session and stored the value in the memory for further computation. To conclude the operation the device 45 then performs step S21 and puts the system to sleep.
  • step S17 is the button 35 is found to be in an ON state, the device 45 jumps back to step S2 and performs the loop all over again as the case may be.
  • a barometric pressure sensor may be conveniently employed instead of the button 35 such that ON/OFF may be detected based on inhalation by the user.
  • Allowance Session is designed to reduce the ease with which a manual dosage may be availed, thereby preventing an abuse of the provision. Even when the user has availed the above provision, the Allowance Session is restricted to the allowance time accumulated through the refill process since the previous Allowance Session.

Abstract

Cette invention concerne système d'administration contrôlée de la nicotine, comprenant un appareil de vaporisation électronique présentant un débit de nicotine normalisé ; un réservoir de nicotine fluide ; un dispositif de communication ; et un dispositif de traitement principal programmé avec un plan le désaccoutumance à nicotine, le plan le désaccoutumance à la nicotine programmé sur le dispositif de traitement principal acceptant une durée cible de désaccoutumance au tabac, le nombre de cigarettes consommées par jour et la nicotine par cigarette en tant qu'entrées et délivrant en sortie une vitesse de recharge, une limite de recharge et un facteur d'atténuation et commandant l'appareil de vaporisation électronique dans une session d'autorisation pour libérer une dose de nicotine, la dose étant proportionnelle à la limite de recharge, chaque session d'autorisation étant suivie d'un intervalle d'interdiction, l'intervalle d'interdiction étant inversement proportionnel à la vitesse de recharge qui se réduit proportionnellement au facteur d'atténuation sur la durée cible de désaccoutumance au tabac. Le système est en outre capable d'exécuter diverses opérations, telles que l'analyse des habitudes en matière de tabagisme de l'utilisateur et de fournir des données statistiques et des notifications sur la base de l'analyse. Ledit système peut être synchronisé avec une pluralité de dispositifs pour fournit une expérience utilisateur instantanée continue.
PCT/IN2016/000236 2015-10-01 2016-09-30 Système d'administration contrôlée de la nicotine qui restreint et atténue progressivement le dosage WO2017056103A1 (fr)

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