US 2014O144429A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2014/0144429 A1 Wensley et al. (43) Pub. Date: May 29, 2014 (54) METHODS AND DEVICES FOR COMPOUND (60) Provisional application No. 61/887,045, filed on Oct. DELIVERY 4, 2013, provisional application No. 61/831,992, filed on Jun. 6, 2013, provisional application No. 61/794, (71) Applicant: E-NICOTINE TECHNOLOGY, INC., 601, filed on Mar. 15, 2013, provisional application Draper, UT (US) No. 61/730,738, filed on Nov. 28, 2012. (72) Inventors: Martin Wensley, Los Gatos, CA (US); Publication Classification Michael Hufford, Chapel Hill, NC (US); Jeffrey Williams, Draper, UT (51) Int. Cl. (US); Peter Lloyd, Walnut Creek, CA A6M II/04 (2006.01) (US) (52) U.S. Cl. CPC ................................... A6M II/04 (2013.O1 (73) Assignee: E-NICOTINE TECHNOLOGY, INC., ( ) Draper, UT (US) USPC ..................................................... 128/200.14 (21) Appl. No.: 14/168,338 (57) ABSTRACT 1-1. Provided herein are methods, devices, systems, and computer (22) Filed: Jan. 30, 2014 readable medium for delivering one or more compounds to a O O Subject. Also described herein are methods, devices, systems, Related U.S. Application Data and computer readable medium for transitioning a Smoker to (63) Continuation of application No. PCT/US 13/72426, an electronic nicotine delivery device and for Smoking or filed on Nov. 27, 2013. nicotine cessation. Patent Application Publication May 29, 2014 Sheet 1 of 26 US 2014/O144429 A1 FIG. 2A 204 -1 2O6 Patent Application Publication May 29, 2014 Sheet 2 of 26 US 2014/O144429 A1 Area liquid is vaporized Electrical Connection Agent O s 2. (e.g., nicotine e ejected) aii Thin wall tubing (0.0005-0.003 inches) Narrower and higher resistance Section Area liquid is vaporized Thick Walled tubing Agent (e.g., nicotine ejected) Battery FIG. 3B Patent Application Publication May 29, 2014 Sheet 3 of 26 US 2014/O144429 A1 502 504 L. FIG. 5 602 Patent Application Publication May 29, 2014 Sheet 4 of 26 US 2014/O144429 A1 Agent (e.g., nicotine) 712 706 702 704 FIG. 7 806 ... : u-N 804 808 802 FIG. 8 904 Patent Application Publication May 29, 2014 Sheet 5 of 26 US 2014/O144429 A1 1002a FIG. 10A Flow rate FIG 11 Patent Application Publication May 29, 2014 Sheet 6 of 26 US 2014/O144429 A1 12O2 1304 FIG. 12 1402 1508 Patent Application Publication May 29, 2014 Sheet 7 of 26 US 2014/O144429 A1 1604b. Heater surface rotated to apply mixture FIG. 16B 1606 FIG. 1.6A Air Flow y - 1 --1706a 1704a fx 1702a1 1708a FIG. 17A Air Flow 1708b-----, -----1710b FIG. 17B Patent Application Publication May 29, 2014 Sheet 8 of 26 US 2014/O144429 A1 Air routing upon valve Opening Piston 1806 Air routing after initial part of inhalation ——Mean Craving Over Time Time FIG. 19 Patent Application Publication May 29, 2014 Sheet 9 of 26 US 2014/O144429 A1 Actual Nicotine Intake Time FIG. 20 2100- 2118 FIG 21 2204 2204 OOOOOOOOOEE To Reservoir 2208 2200 FIG. 22 Patent Application Publication May 29, 2014 Sheet 10 of 26 US 2014/O144429 A1 2304 FIG. 24 2504a 2502a —Al- 2506a -b FIG. 25A 2504b. 2506b FIG. 25B Patent Application Publication May 29, 2014 Sheet 11 of 26 US 2014/O144429 A1 s Patent Application Publication May 29, 2014 Sheet 12 of 26 US 2014/O144429 A1 FIG. 27B 2712C FIG. 27C FIG. 27D Patent Application Publication May 29, 2014 Sheet 13 of 26 US 2014/O144429 A1 ` §N 0||89†7/"ZZ9"|Z"6'0"OG'OºL’O80°090°0#70'OZO"O +07 09 9€. SSeW ---------------------------------------------------------------------------------------------------·+OZ Lae9|, *0|| ---------`--------9 `Sae0 Patent Application Publication May 29, 2014 Sheet 14 of 26 US 2014/O144429 A1 3/4 inch radius Flow to flow meter VaC u-291 Oa F.G. 29B FIG. 29A ? 3000a 3002b 3/8 inch D radius L FIG. 30A FIG. 30B Patent Application Publication May 29, 2014 Sheet 15 of 26 US 2014/0144429 A1 FIG. 31A FIG. 31B Patent Application Publication May 29, 2014 Sheet 16 of 26 US 2014/O144429 A1 31 O2C 31 O2C 3106C (-) (+) 3112C 3112d FIG. 31C FIG. 31D FIG. 31E Patent Application Publication May 29, 2014 Sheet 17 of 26 US 2014/O144429 A1 FIG. 32A Mixing ratio (28x) Mixing ratio (7x) 3204b. -U \ 3204C N. V 3202b FIG. 32B FIG. 32C Patent Application Publication May 29, 2014 Sheet 18 of 26 US 2014/O144429 A1 FIG. 32D FIG. 32E Patent Application Publication May 29, 2014 Sheet 19 of 26 US 2014/O144429 A1 FIG. 33 3702 A - 3704 - (- 37O6 FIG. 34 Patent Application Publication May 29, 2014 Sheet 20 of 26 US 2014/O144429 A1 3504 % 3610 Air flow Brass contact (+) Brass contact (-) 3602a 36O2b FIG. 36 Patent Application Publication May 29, 2014 Sheet 21 of 26 US 2014/O144429 A1 3704a 3704b. FIG. 37A FIG. 37B 3804 Patent Application Publication May 29, 2014 Sheet 22 of 26 US 2014/O144429 A1 User Devices 3902 Electronic Agent Delivery Device FIG. 39 User Devices 4002 Data Collector Electronic Agent Delivery Device Engine FIG. 40 Patent Application Publication May 29, 2014 Sheet 23 of 26 US 2014/O144429 A1 Optional 4108 Display Processing 4104 Unit Computer readable storage medium Operating System 41 12 Agent Delivery Routine 41 14 4106 FIG. 41 Patent Application Publication May 29, 2014 Sheet 24 of 26 US 2014/O144429 A1 ?ouenbesesoC]fiu?pueosy Œ?s??]+|aopela: firi000!:&#dnouÐ Patent Application Publication May 29, 2014 Sheet 25 of 26 US 2014/O144429 A1 -?ud Patent Application Publication May 29, 2014 Sheet 26 of 26 US 2014/O144429 A1 US 2014/0144429 A1 May 29, 2014 METHODS AND DEVICES FOR COMPOUND um can be too large to reach the deep lung because the DELIVERY particles can impact in the mouth and upper airway, resulting in a slow PK. Conversely, aerosol particles with a median CROSS-REFERENCE aerodynamic diameter of less than 1 um can be small enough to reach the deep lung but can be too light to gravitationally 0001. This application is a continuation of PCT Applica settle and can be exhaled, which can result in low dose deliv tion No. PCT/US 13/72426, filed Nov. 27, 2013, which claims ery. Additionally, aerosols with Small aerosol particle size can the benefit of U.S. Provisional Application No. 61/730,738, contain a larger percentage of the mass in the gas phase, filed on Nov. 28, 2012, 61/794,601, filed on Mar. 15, 2013, which rapidly diffuses to the mouth and upper airway. Aero 61/831,992, filed on Jun. 6, 2013, and 61/887,045, filed on Sol particles with an aerodynamic diameter of about 1 um to Oct. 4, 2013, which applications are incorporated herein by about 5 um can be small enough to reach the deep lung but reference in their entirety. large enough to gravitationally settle in alveoli, which can result in a rapid PK. A need exists for electronic nicotine BACKGROUND delivery devices that produce Such particles. In addition, a 0002. There is a need for new methods and devices for need exists for producing nicotine aerosols that produce Such administering compounds, such as pharmaceutical agents, to particles using the liquid drug. Moreover, a need exists for a Subject. In particular, there is a need for methods and methods of using Such devices to help users achieve a par devices for delivery of compounds to a subject where the ticular health goal or goals. compounds are aerosolized to fall within a specified particle 0006. Also, a need exists for considering behavioral fac size range. In some cases, particles within a specified size tors in Smoking relapse and for integrating Smoking cessation range can be efficiently delivered to the deep lung. For programs with Social media to facilitate and maintain behav example, there is an urgent need for improved methods and ior change. devices to deliver nicotine to a Subject in specified doses and 0007. There is also a need for a drug delivery platform that in a specified particle range size without the carcinogens and is capable of dispensing a variety of drugs to a Subject in a other chemicals associated with combustible tobacco prod specified dose or in a specified particle size range. uctS. 0003. In 2011, an estimated 19% of U.S. adults were cur SUMMARY rent smokers (43.8 million people), and an estimated 950 0008. In one aspect, a condensation aerosol generating children become addicted to Smoking daily. Smokers spend device for generating a condensation aerosol from a liquid approximately $83 billion to support their habit, and half of formulation is provided, the device comprising: a) a reservoir smokers will die from their habit. Studies indicate that about comprising a liquid formulation; and b) a passageway com 85% of smokers want to quit; however, only about 5% suc prising a heater element, an inlet, and an outlet, wherein the ceed. heater element is disposed in the passageway between the 0004 Current nicotine replacement therapies (NRTs) are inlet and the outlet, wherein the reservoir is in fluid commu not effective for approximately 85% of users. In some cases, nication with the heater element, and wherein the passageway existing NRTs and electronic cigarettes (eCigs) fail to provide is configured to produce a condensation aerosol in the device, sufficient doses of nicotine. Many smokers using NRTs wherein the condensation aerosol has a mass median aerody under-dose, resulting in break-through cravings, which can namic diameter (MMAD) of from about 1 um to about 5um. lead to Smoking lapses and eventual relapse.