Dual chamber electronic nicotine delivery system with puff duration control and timed lockout and just-in-time adaptive intervention to treat nicotine dependence in cigarette smokers

Abstract

A portable device body includes a puff opening from an inner passage. A vapor source deliver into an airflow through the inner passage a vaporized content according to a program. The program includes a first phase and a second phase. Delivery according to the first phase sets and changes, according to a first phase dosage change trajectory, a nicotine dosage from a starting nicotine dosage to an ending nicotine dosage. Delivery according to the second phase sets and changes a nicotine-to-placebo ratio according to a second phase dosage change trajectory, from a starting nicotine-to-placebo ratio to an effective zero nicotine-to-placebo ratio. The first phase dosage change trajectory is configured as statistically likely to result in user shift of nicotine intake, from smoking to electronic nicotine delivery. The second phase change trajectory is configured as statistically likely to result in user elimination of nicotine intake

We claim: 
     
         1 . A system for two-phase dosage control (TPDC) based electronic nicotine delivery treatment for cessation of smoking and nicotine intake, comprising:
 a portable device body, comprising structure forming a puff opening fluidically connected to an inner passage, in an arrangement wherein user puffs applied to the puff opening pull an airflow through the inner passage, and out from the puff opening; and   a program-based dynamically controlled vapor source, configured to deliver into the airflow a vaporized content according to a program, the program comprising a first phase program and a second phase program, wherein:
 delivery according to the first phase program comprises setting and controlling the vaporized content with a configuration that delivers into the airflow a nicotine dosage and that controls the delivered nicotine dosage according to a first phase dosage trajectory, from a starting nicotine dosage to an ending nicotine dosage, and 
 delivery according to the second phase program comprises setting and controlling the vaporized content as a nicotine-to-placebo ratio content and changing the ratio, according to a second phase dosage change trajectory, from a starting, non-zero nicotine-to-placebo ratio to an effective zero nicotine-to-placebo ratio, the second phase dosage change trajectory is configured as statistically likely to result in an elimination of nicotine intake. 
   
     
     
         2 . The system of  claim 1  for TPDC based electronic nicotine delivery treatment for cessation of smoking and nicotine intake, wherein the program-based dynamically controlled vapor source is further configured to:
 a) count first phase puffs by the subject, and to measure timing features of the first phase puffs and, based at least in part on the count of the first phase puffs or the timing features of the first phase puffs, or both, to detect occurrence of first phase puff sessions by the subject and to count the detected occurrences of first phase puff sessions by the subject, or 
 b) count second phase puffs by the subject, and to measure timing features of the second phase puffs and, based at least in part on the count of the second phase puffs or the timing features of the second phase puffs, or both, to detect second phase puff sessions by the subject and to count the detected second phase puff sessions by the subject, or both a) and b). 
 
     
     
         3 . The system of  claim 1  for TPDC based electronic nicotine delivery treatment for cessation of smoking and nicotine intake, wherein: the second phase dosage change trajectory is configured as statistically likely to result in an elimination of nicotine intake. 
     
     
         4 . The system of  claim 1  for TPDC based electronic nicotine delivery treatment for cessation of smoking and nicotine intake, wherein the second phase program is configured to change the nicotine-to-placebo ratio by controlling a nicotine-to-placebo statistical ratio of a random selecting, on a per-puff basis, between nicotine content and placebo content, wherein:
 the random selecting includes generating a random number according to a uniform probability density function, and comparing the generated number against a selection comparison threshold, and 
 changing the ratio comprises changing the stored selection comparison threshold to an updated selection comparison threshold. 
 
     
     
         5 . The system of  claim 1  for TPDC based electronic nicotine delivery treatment for cessation of smoking and nicotine intake, wherein the first phase program further comprises a programmable lock-out process, which comprises:
 enabling, for an enablement time interval, the programmable vapor source to deliver into the airflow the vaporized content, and 
 disabling, for a lock-out time interval, the programmable vapor source from delivering into the airflow the vaporized content. 
 
     
     
         6 . The system of  claim 1  for TPDC based electronic nicotine delivery treatment for cessation of smoking and nicotine intake, wherein the second phase program further comprises a programmable time-out process, which comprises:
 enabling, for an enablement time interval, the programmable vapor source to deliver into the airflow the nicotine-to-placebo ratio content, 
 limiting, for a time-out time interval, the programmable vapor source into the airflow a placebo-only content, 
 progressively increasing the time-out time interval, during at least a portion of the second phase change trajectory. 
 
     
     
         7 . The system of  claim 1  for TPDC based electronic nicotine delivery treatment for cessation of smoking and nicotine intake, wherein the programmable vapor source comprises:
 a two-phase dynamic vapor delivery control logic, configured to generate vapor delivery commands in accordance with the first phase program and the second phase program; and 
 a vapor content selection and delivery apparatus, supported by the portable structure and communicatively coupled to the vapor content control logic, comprising
 a first reservoir configured to hold an amount of nicotine-containing liquid, 
 a second reservoir configured to hold an amount of nicotine-free liquid, 
 a first atomizer, having a first atomization surface in or incident to the inner passage, 
 a first transfer element, configured to switch in accordance with the vapor delivery command between a first element OFF state and a first element ON state, the ON state providing transfer of content of the first reservoir to the first atomizer, 
 a second transfer element, configured to switch in accordance with the vapor delivery command between a second element OFF state and a second element ON state, the ON providing transfer of content of the second reservoir to the second atomizer. 
 
 
     
     
         8 . The system of  claim 7  for TPDC based electronic nicotine delivery treatment for cessation of smoking and nicotine intake, wherein:
 the inner passage includes an inner passage first segment that extends to a passage neck-down, and an inner passage second segment that extends from the passage neck-down toward the puff opening, 
 the first atomizer is positioned within the inner passage first segment, 
 the second atomizer is positioned within the inner passage second segment, 
 the inner passage first segment has a passage first diameter, and an atomizer surface of the first atomizer extends across the passage first diameter, and 
 the inner passage second segment has a passage second diameter, and an atomizer surface of the second atomizer extends across the passage second diameter. 
 
     
     
         9 . The system of  claim 1  for TPDC based electronic nicotine delivery treatment for cessation of smoking and nicotine intake, wherein:
 the mobile structure includes a case, the inner passage is within the case, and includes a mouthpiece structure, attached to or integral with the case, surrounds the puff opening, and 
 the vapor content control logic comprises a distributed programmable vapor control processor, including a combination of an external programmable processing resource external to the case, a local vapor control resource supported within the case, and a local protocol communication link between the external programmable processing resource and the local vapor control resource. 
 
     
     
         10 . A method for two-phase dosage control (TPDC) based electronic nicotine delivery treatment for cessation of smoking and nicotine intake, comprising:
 responsive to a first succession of instances of a subject's puff induced airflow through a passage toward a puff opening, delivering from the puff opening corresponding instances of a vaporized nicotine, at dosages in accordance with a first phase program, wherein the delivering includes receiving information indicative of puff characteristics of the subject that relate to actual received nicotine dosage by the subject relative to vaporized nicotine delivery operation by the system and, based on the information, performing adjustments of the delivery to conform the actual received dosage to the first phase program;   responsive to second first succession of instances of the subject's puff induced airflow, delivering from the puff opening corresponding instances of a vaporized nicotine-to-placebo ratio content and changing the ratio, according to a second phase content change trajectory, from a starting, non-zero nicotine-to-placebo ratio to an effective zero nicotine-to-placebo ratio.   
     
     
         11 . The method of  claim 10  for TPDC based electronic nicotine delivery treatment for cessation of smoking and nicotine intake, wherein the method further comprises:
 counting first phase puffs by the subject, and counting first phase puff sessions by the subject, each of the first phase puff sessions comprising a respective plurality of separate first phase puff actions by the subject, and 
 counting second phase puffs by the subject, and counting second phase puff sessions by the subject, each of the second phase puff sessions comprising a respective plurality of separate second phase puff actions by the subject. 
 
     
     
         12 . The method of  claim 11  for TPDC based electronic nicotine delivery treatment for of cessation of smoking and nicotine intake, wherein:
 changing, according to the second phase content change trajectory, from the starting, non-zero nicotine-to-placebo ratio to the effective zero nicotine-to-placebo ratio dosage includes effectuating at least of the ratio changes as a per-session ratio change, nicotine dosage change; and 
 the second phase program is further configured to effectuate at least one of the ratio changes as a per-session ratio change. 
 
     
     
         13 . The method of  claim 10  for TPDC based electronic nicotine delivery treatment for of cessation of smoking and nicotine intake, wherein the second phase dosage change trajectory is configured as statistically likely to result in an elimination of nicotine intake. 
     
     
         14 . The method of  claim 10  for TPDC based electronic nicotine delivery treatment for cessation of smoking and nicotine intake, wherein the second phase program is configured to change the nicotine-to-placebo ratio by controlling a nicotine-to-placebo statistical ratio of a random selecting, on a per-puff basis, between nicotine content and placebo content, wherein:
 the random selecting includes generating a random number according to a uniform probability density function, and comparing the generated number against a selection comparison threshold, and 
 changing the ratio comprises changing the stored selection comparison threshold to an updated selection comparison threshold. 
 
     
     
         15 . The method of  claim 10  for TPDC based electronic nicotine delivery treatment for cessation of smoking and nicotine intake, wherein the first phase program further comprises a programmable lock-out process, which comprises:
 enabling, for an enablement time interval, the programmable vapor source to deliver into the airflow the vaporized content, and 
 disabling, for a lock-out time interval, the programmable vapor source from delivering into the airflow the vaporized content. 
 
     
     
         16 . The method of  claim 10  for TPDC based electronic nicotine delivery treatment for cessation of smoking and nicotine intake, wherein the second phase program further comprises a programmable time-out process, which comprises:
 enabling, for an enablement time interval, the programmable vapor source to deliver into the airflow the nicotine-to-placebo ratio content, 
 limiting, for a time-out time interval, the programmable vapor source into the airflow a placebo-only content, 
 progressively increasing the time-out time interval, during at least a portion of the second phase change trajectory.