US 2014O190496A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2014/0190496 A1 Wensley et al. (43) Pub. Date: Jul. 10, 2014 (54) METHODS AND DEVICES FOR COMPOUND filed on Mar. 15, 2013, provisional application No. DELIVERY 61/831,992, filed on Jun. 6, 2013, provisional applica tion No. 61/887,045, filed on Oct. 4, 2013. (71) Applicant: E-NICOTINE TECHNOLOGY, INC., Draper, UT (US) Publication Classification (72) Inventors: Martin Wensley, Los Gatos, CA (US); (51) Int. Cl Michael Hufford, Chapel Hill, NC we (US); Jeffrey Williams, Draper, UT A24F 47/00 (2006.01) (US); Peter Lloyd, Walnut Creek, CA (52) U.S. Cl. (US) CPC .................................... A24F 47/008 (2013.01) USPC ........................................... 131/273; 131/328 (73) Assignee: E-NICOTINE TECHNOLOGY, INC., Draper, UT (US) (57) ABSTRACT (21) Appl. No.: 14/092,405 Provided herein are methods, devices, systems, and computer (22) Filed: Nov. 27, 2013 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 (60) Provisional application No. 61/730,738, filed on Nov. an electronic nicotine delivery device and for Smoking or 28, 2012, provisional application No. 61/794,601, nicotine cessation. A O A-Cl Patent Application Publication Jul. 10, 2014 Sheet 1 of 26 US 2014/O190496 A1 102 sts ss : X:X.8 : 8 8: X. y 2O2 KXXXXXXXXXXXXX: XXXXXXXXX& FIG. 2A XXXXXXXXXXX 204 - X8XXXXXXXXXX xxxxxxxx 2O6 ''''7-210 2 FIG. 2B 212 Patent Application Publication Jul. 10, 2014 Sheet 2 of 26 US 2014/O190496 A1 Area liquid is vaporized Electrical COnnection Thin wall tubing (0.0005-0.003 inches) Narrower and higher Area liquid is vaporized ? resistance Section Thick Walled 2x M2 tubing Battery FIG. 3B Patent Application Publication Jul. 10, 2014 Sheet 3 of 26 US 2014/O190496 A1 408 400 53.5 S to sis 6% xx EXx: -N4 RNA x XXX: : 406 xxxx: : ser. E. E. E. E. E. E. R. R. 4 is 6& % X. 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X 8.: 8& 3 :: 88:: X** 8. x 802 906 xxxxxxxxxxxx 8XXXXXX:XXXXXXXXXXX: 910 OX8. 904 XxxxxXXXXXXX: 908 Patent Application Publication Jul. 10, 2014 Sheet 6 of 26 US 2014/O190496 A1 Airflow Airflow ! 12O2 1304 1402 1508 XXXXXXxxxxxx xxxxxxxx XXX:XXX x2%8XXXXXXXXXX: % Patent Application Publication Jul. 10, 2014 Sheet 7 of 26 US 2014/O190496 A1 : : 8:: 3 : x3. & 8 X83 3 8X 3. 3 3 83 ::3 s : u1 Heater Surface & x8. rotated to apply mixture 3.X: 3. 1602 FIG. 16B 1606 1702a 1708a FIG. 17A Air EtFOW 1708b-----, --- 1710b FIG. 17B Patent Application Publication Jul. 10, 2014 Sheet 8 of 26 US 2014/O190496 A1 Air routing upon valve opening V PiSton 1806 Air routing after initial part of inhalation 1808 xx 1802 : Air Flow FIG. 18 Mean NiCOtine Intake - - - - - - - - - - - - - - - - - ------------------------------ Reduced Challenge Dose-e- ——-Mean Craving Over Time Time FIG. 19 Patent Application Publication Jul. 10, 2014 Sheet 9 of 26 US 2014/O190496 A1 Actual Nicotine Intake Time FIG. 20 2204 % X. 2204 2. al Y Ty" To Evoir 22O2 22O6 2200 FIG. 22 Patent Application Publication Jul. 10, 2014 Sheet 10 of 26 US 2014/O190496 A1 23O2 xxxxxxxxxxxx X xxxx&Xxxxxxxxxxxx C27AXxxxxxxx 2304 8xxxxxxxxxX& XXXXXXXX FIG. 23 X. &XXXXXXXX: 3 3. X X& XXXXXXXXXXXX:&S 2404 &(XXXXXXXXXXXXX r KXXXXXXXXXXXX)& :: 3.3. & K xxxX X X : : : : 38& us :xx X X X X X X X X 8: 8 8: FIG. 25A FIG. 25B Patent Application Publication Jul. 10, 2014 Sheet 11 of 26 US 2014/O190496 A1 s i. Patent Application Publication Jul. 10, 2014 Sheet 12 of 26 US 2014/O190496 A1 - - - 27.12b FIG. 27B FIG. 27C FIG. 27D Patent Application Publication Jul. 10, 2014 Sheet 13 of 26 US 2014/O190496 A1 & 3. : 09 SSeW Patent Application Publication Jul. 10, 2014 Sheet 14 of 26 US 2014/O190496 A1 2902b -4Cy M 9 3/4 inch radiuS Flow to flow meter VaC - 291 Oa FIG. 29A FIG. 29B ? 3OOOa - 30O2b 3/8 inch s D radius L FIG. 30A FIG. 30B Patent Application Publication Jul. 10, 2014 Sheet 15 of 26 US 2014/O190496 A1 31 O2a 3104a SSS. NS. S. S & S 2% & -- 31.12a 3112b FIG. 31A FIG. 31B Patent Application Publication Jul. 10, 2014 Sheet 16 of 26 US 2014/O190496 A1 31 O2C 31 O2C - 31 O6C A. -- 31 O6C (+) (-) S. & (+) N N (-) 3112C 3112d FIG. 31C FIG. 31D & -3114e % % -3116e z FIG. 31E Patent Application Publication Jul. 10, 2014 Sheet 17 of 26 US 2014/O190496 A1 s XS. E L 3206a S FIG. 32A Mixing ratio (28X) Mixing ratio (7x) 3202b 32O2C 3204b. -U \ 3204C N 32O2C FIG. 32B FIG. 32C Patent Application Publication Jul. 10, 2014 Sheet 18 of 26 US 2014/O190496 A1 3206e ==N 3204e 5-5-5-5-5-5-5-5-5-5-5-5-4 No. FIG. 32D FIG. 32E Patent Application Publication Jul. 10, 2014 Sheet 19 of 26 US 2014/O190496 A1 2% Y------------ / 3304 -CH 33O8 SS, ?AN N FIG. 33 or) N) O CN FIG. 34 Patent Application Publication Jul. 10, 2014 Sheet 20 of 26 US 2014/O190496 A1 3504 3528 YXYYYYYYYYYYYYYYYY -o- 1N 13506 2A. Z 2 352O 2Zzz% 3512 3526 2 -b 3516 Z. a 3530 PN 3508 FIG. 35 3610 3606 Air flow s 3608 CE 3E 36O4a 36O4b Brasslet (+) 3 3 Brassic (-) FIG. 36 Patent Application Publication Jul. 10, 2014 Sheet 21 of 26 US 2014/O190496 A1 3702b 3704a 3704b. FIG. 37A FIG. 37B 38O6 3804 3810 38O2 FIG. 38 Patent Application Publication Jul. 10, 2014 Sheet 22 of 26 US 2014/O190496 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 Jul. 10, 2014 Sheet 23 of 26 US 2014/O190496 A1 NetWork 41 O2 Interface Optional 4108 Display Processing 41 O4 Unit Computer readable storage medium Operating System 41 12 Agent Delivery Routine 41 14 4106 FIG. 41 Patent Application Publication Jul. 10, 2014 Sheet 24 of 26 US 2014/O190496 A1 Patent Application Publication Jul. 10, 2014 Sheet 25 of 26 US 2014/O190496 A1 6riCIAL Patent Application Publication Jul. 10, 2014 Sheet 26 of 26 US 2014/O190496 A1 (WriGS) FSLISSZS 9077 US 2014/O 190496 A1 Jul. 10, 2014 METHODS AND DEVICES FOR COMPOUND in a slow PK. Conversely, aerosol particles with a median DELIVERY aerodynamic diameter of less than 1 um can be small enough to reach the deep lung but can be too light to gravitationally CROSS-REFERENCE settle and can be exhaled, which can result in low dose deliv ery. Additionally, aerosols with Small aerosol particle size can 0001. This application claims the benefit of U.S. Provi contain a larger percentage of the mass in the gas phase, sional Application Nos. 61/730,738, filed on Nov. 28, 2012, which rapidly diffuses to the mouth and upper airway. Aero 61/794,601, filed on Mar. 15, 2013, 61/831,992, filed on Jun. Sol particles with an aerodynamic diameter of about 1 um to 6, 2013, and 61/887,045, filed on Oct. 4, 2013, which appli about 5 um can be small enough to reach the deep lung but cations are incorporated herein by 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.