(12) United States Patent
`Cox et al.
`
`(10) Patent No.:
`(45) Date of Patent:
`
`US 7,117,867 B2
`*Oct. 10, 2006
`
`US0071 17867B2
`
`(54) AEROSOL GENERATOR AND METHODS OF
`MAKING AND USING AN AEROSOL
`GENERATOR
`
`(75) Inventors: Kenneth A. Cox, Midlothian, VA (US);
`Timothy Paul Beane, Richmond, VA
`(US); William R. Sweeney, Richmond,
`VA (US); Walter A. Nichols,
`Chesterfield, VA (US); F. Murphy
`Sprinkel, Jr., Richmond, VA (US)
`
`(73) Assignee: Philip Morris USA, Richmond, VA
`(US)
`
`(*) Notice:
`
`Subject to any disclaimer, the term of this
`patent is extended or adjusted under 35
`U.S.C. 154(b) by 9 days.
`
`This patent is Subject to a terminal dis-
`claimer.
`
`(21) Appl. No.: 10/438,329
`
`(22) Filed:
`
`May 15, 2003
`
`(65)
`
`Prior Publication Data
`
`US 2004/0050383 A1
`
`Mar. 18, 2004
`
`Related U.S. Application Data
`(63) Continuation of application No. 10/247,776, filed on
`Sep. 20, 2002, now abandoned, which is a continu-
`ation of application No. 09/479,597, filed on Jan. 7,
`2000, now Pat. No. 6,516,796, which is a continua-
`tion of application No. PCT/US99/24080, which is a
`continuation of application No. 09/172,023, filed on
`Oct. 14, 1998, now Pat. No. 6,234,167.
`
`(51) Int. Cl.
`A6M II/00
`A6M I5/00
`A6M 16/00
`FI6K II/00
`
`(2006.01)
`(2006.01)
`(2006.01)
`(2006.01)
`
`
`
`(52) U.S. Cl. ........................... 128/200.14; 128/200.18:
`128/200.21; 128/203.12; 128/203.21; 128/203.25;
`128/2O3.26
`(58) Field of Classification Search ........... 128/200.14,
`128/200.18, 200.21, 203.12, 203.21, 203.25,
`128/2O3.26
`See application file for complete search history.
`References Cited
`U.S. PATENT DOCUMENTS
`
`(56)
`
`7, 1959 Kravits
`2,896,856 A
`4, 1963 Smith
`3,084,698 A
`3,157,179 A 11/1964 Paullus et al.
`3,162,324. A 12/1964 Houser
`3.431,393 A
`3, 1969 Katsuda
`3,486,663 A 12/1969 Humphrey
`3,658,059 A
`4, 1972 Steil
`3,716,416 A
`2f1973 Adlhart et al.
`3,750,961 A
`8, 1973 Franz
`3,847.304 A 11/1974 Cohen
`3,859,398 A
`1/1975 Havstad
`3,902,635 A
`9, 1975 Jinotti
`3,903,883 A
`9, 1975 Pecina et al.
`3,904,083. A
`9, 1975 Little
`3,967,001 A
`6, 1976 Almaula et al.
`3,987,941 A 10/1976 Blessing
`3,993,246 A 11/1976 Erb et al.
`3,995,371 A 12, 1976 O’Keefe
`4,042,153 A
`8, 1977 Callahan et al.
`4,060,082 A 11/1977 Lindberg et al.
`4,077.542 A
`3, 1978 Petterson
`4,161.282 A
`7, 1979 Erb et all
`4.162.50. A
`7, 1979 Micheletal
`4.25.70s. A
`8, 1980 Bron
`4,231.49 A 11/1980 Rios
`4,258,073. A
`3/1981 Payne
`4,259,409 A
`3, 1981 Arnold
`4,261,356 A
`4, 1981 Turner et al.
`4.289,003 A
`9/1981 Yang
`4,291,838 A
`9/1981 Williams
`4,303,083. A 12/1981 Burruss, Jr.
`4,383,171 A
`5/1983 Sinha et al.
`4,391.308 A
`7/1983 Steiner
`
`25
`
`Philip Morris Products, S.A.
`Exhibit 1026
`Page 001
`
`

`

`US 7,117,867 B2
`Page 2
`
`7, 1983 Weir
`4,395,303 A
`2f1984 Galia
`4.433,797 A
`9, 1984 Coleman
`4,471,892 A
`4, 1985 Lester
`4,512,341 A
`3, 1986 Fassel et al.
`4.575,609 A
`4,627,432 A 12/1986 Newell et al.
`4,649,911 A
`3/1987 Knight et al.
`4,682,010 A
`7/1987 Drapeau et al.
`4,695,625 A
`9, 1987 Macdonald
`4,700,657 A 10, 1987 Butland
`4,730, 111 A
`3, 1988 Vestal et al. ................ 250/288
`4,735,217 A
`4, 1988 Gerth et al. ................ 131,273
`4,744.932 A
`5, 1988 Browne
`4,749,778 A
`6, 1988 Fukuzawa et al.
`4,762.995 A
`8, 1988 Browner et al.
`4,776,515 A * 10/1988 Michalchik .................... 239,3
`4,790,305 A 12/1988 Zoltan et al.
`4,811,731 A
`3, 1989 Newell et al.
`4,819,374. A
`4, 1989 Gemgnani
`4,819,834 A
`4, 1989 Thiel
`4,829,996 A
`5, 1989 Noakes et al.
`4,837,260 A
`6, 1989 Sato et al.
`4,848,374. A
`7, 1989 Chard et al.
`4,871,115 A 10/1989 Hessey
`4,871,623 A 10/1989 Hoopman et al.
`4,877,989 A * 10/1989 Drews et al. .......... 310,323.01
`4,911,157 A
`3, 1990 Miller
`4,922.901 A
`5, 1990 Brooks et al.
`4,926,852 A
`5, 1990 Zoltan et al.
`4,935,624. A * 6/1990 Henion et al. .............. 250/288
`4.941,483. A
`7/1990 Ridings et al.
`4,947,875 A
`8, 1990 Brooks et al.
`4,974,754 A 12, 1990 Wirz
`4,982,097 A
`1, 1991 Siwon et al.
`4,992,206 A
`2f1991 Waldron
`5,021,802 A
`6, 1991 Allred
`5,044,565 A
`9, 1991 Alexander
`5,056,511 A 10/1991 Ronge
`... 131,329
`5,060.671 A 10, 1991 Counts et al. .
`5,063,921 A 11/1991 Howe .................... 128.200.14
`5,096,092 A
`3, 1992 Devine
`5,125,441 A
`6, 1992 Mette
`5,133,343 A
`7, 1992 Johnson et al.
`5,134,993 A * 8, 1992 van der Linden
`et al. ..................... 128.200.14
`8, 1992 Miller et al.
`5,135,009 A
`9, 1992 Counts et al.
`5,144.962 A
`9, 1992 Venet al.
`5,151,827 A
`1/1993 Keller
`5,178,305 A
`2f1993 Minier
`5,184,776 A
`5,217,004 A * 6/1993 Blasnik et al. ......... 128.200.23
`5,226,441 A
`7, 1993 Dunmire et al.
`5,228,444. A
`7, 1993 Burch ........................ 600,431
`5,230,445 A
`7, 1993 RuSnak
`5,231983 A
`8, 1993 Matson et al.
`5,259,370 A 11/1993 Howe .................... 128.200.14
`5,284,133 A
`2, 1994 Burns et al. ........... 128.200.23
`5,290,540 A
`3, 1994 Prince et al.
`5,298,744 A
`3, 1994 Mimura et al.
`5,299,565 A
`4, 1994 Brown
`5,322,057 A
`6, 1994 Raabe et al.
`5,327,915 A
`7, 1994 Porenski et al.
`5,342,180 A
`8, 1994 Daoud
`5,342,645 A
`8, 1994 Eisele et al.
`5,349,946 A * 9, 1994 McComb ............... 128,20317
`5,395,445 A
`3, 1995 Bohanan
`5,421,489 A
`6/1995 Holzner, Sr. et al.
`5,462,597 A 10, 1995 Jubran
`5,474,059 A 12/1995 Cooper .................. 128.200.22
`5,487.378 A *
`1/1996 Robertson et al. ..... 128.200.16
`5,509,557 A
`4, 1996 Jimarez et al.
`5,515,842 A
`5/1996 Ramseyer et al.
`5,522,385 A * 6/1996 Lloyd et al. ........... 128,203.26
`
`
`
`9, 1996 Hofstraat et al.
`5,556,964 A
`5,564,442 A 10, 1996 MacDonald et al.
`5,565,677 A 10, 1996 Wexler
`5,575,929 A 11/1996 Yu et al.
`5,585,045 A 12/1996 Heinonen et al. .......... 261 72.1
`5,617,844 A
`4/1997 King
`5,642,728 A
`7/1997 Andersson et al.
`5,674,860 A 10/1997 Carling et al.
`5,682,874 A 11/1997 Grabenkort et al.
`5,730,158 A
`3, 1998 Collins et al.
`5,743,251 A
`4/1998 Howell et al. ......... 128.200.14
`5,755,218 A
`5/1998 Johansson et al.
`5,756,995 A
`5/1998 Maswadeh et al.
`5,765,724. A
`6/1998 Amberg et al.
`5,813,397 A
`9, 1998 Goodman et al.
`5,823, 178 A 10/1998 Lloyd et al.
`5,839,430 A 11/1998 Cama
`5,855,202 A
`1/1999 Andrade
`5,856,671 A
`1/1999 Henion et al.
`5,863,652 A
`1/1999 Matsumura et al.
`5,869,133 A
`2/1999 Anthony et al.
`5,872,010 A
`2/1999 Karger et al.
`5,878,752 A
`3, 1999 Adams et al.
`5,881,714 A
`3, 1999 Yokoi et al.
`5,906,202 A
`5/1999 Schuster et al.
`5,914,122 A
`6/1999 Otterbeck et al.
`5,932.249 A
`8, 1999 Gruber et al.
`5,932,315 A
`8, 1999 Lum et al.
`5,934,272 A
`8/1999 Lloyd et al.
`5,934,273 A
`8/1999 Andersson et al.
`5,944,025 A
`8, 1999 Cook et al.
`5,954,979 A
`9, 1999 Counts et al.
`5,957,124. A
`9/1999 Lloyd et al.
`5,970,973 A 10/1999 Gonda et al.
`5,970,974 A 10, 1999 Van Der Linden et al.
`5,978,548 A 11/1999 Holmstrand et al.
`5,993,633. A 11/1999 Smith et al.
`6,014,970 A
`1/2000 Ivri et al.
`6,053,176 A
`4/2000 Adams et al.
`6,054,032 A
`4/2000 Haddad et al.
`6,069,214. A
`5, 2000 McCormick et al.
`6,069,219 A
`5, 2000 McCormick et al.
`6,070,575 A
`6/2000 Gonda et al.
`6,071,428 A
`6/2000 Franks et al.
`6,071,554 A
`6/2000 Isomura et al.
`6,076,522 A
`6/2000 Dwivedi et al.
`6,077,543 A
`6/2000 Gordon et al.
`6,080,721 A
`6/2000 Patton
`6,085,740 A
`7/2000 Ivri et al.
`6,085,753. A
`7/2000 Gonda et al.
`6,089,228 A
`7/2000 Smith et al.
`6,095,153 A
`8, 2000 Kessler et al.
`6,098,615 A
`8/2000 Lloyd et al.
`6,098.620 A
`8/2000 Lloyd et al.
`6,103,270 A
`8/2000 Johnson et al.
`6,116,516 A
`9/2000 Ganan-Calvo
`6,116,893 A
`9, 2000 Peach
`6,119,953. A
`9/2000 Ganan-Calvo
`6,123,068 A
`9/2000 Lloyd et al.
`6,123,936 A
`9, 2000 Platz et al.
`6,131,567 A 10/2000 Gonda et al.
`6,131,570 A 10/2000 Schuster et al.
`6,136,346 A 10/2000 Eljamal et al.
`6,138,668 A 10/2000 Patton et al.
`6,155,268 A 12/2000 Takeuchi
`6,158,431 A 12, 2000 Poole
`6,158,676 A 12/2000 Hughes
`6,159,188 A 12/2000 Laibovitz et al.
`6,164,630 A 12/2000 Birdsell et al.
`6,165,463 A 12/2000 Platz et al.
`6,167,880 B1
`1/2001 Gonda et al.
`6,174,469 B1
`1/2001 Ganán-Calvo
`6,182,712 B1
`2/2001 Stout et al.
`
`Philip Morris Products, S.A.
`Exhibit 1026
`Page 002
`
`

`

`US 7,117,867 B2
`Page 3
`
`2/2001 Ganan-Calvo
`6,187,214 B1
`2/2001 Eljamal et al.
`6,187,344 B1
`2/2001 Ganan-Calvo
`6,189,803 B1
`2/2001 Gonda
`6, 192,882 B1
`3/2001 Ganan-Calvo
`6, 197,835 B1
`6,205,999 B1* 3/2001 Ivri et al. .............. 128.200.22
`6,206.242 B1
`3/2001 Amberg et al.
`6,207,135 B1
`3/2001 Rössling et al.
`6,223,746 B1
`5, 2001 Jewett et al.
`6,230,706 B1* 5/2001 Gonda et al. .......... 128.20312
`6,231,851 B1
`5, 2001 Platz et al.
`6,234,167 B1 * 5/2001 Cox et al. .............. 128.200.14
`6,234.402 B1
`5/2001 Ganan-Calvo
`6,235,177 B1
`5, 2001 Borland et al.
`6,250,298 B1
`6/2001 Gonda et al.
`6,257,233 B1
`7/2001 Burr et al.
`6,258,341 B1
`7/2001 Foster et al.
`6,263,872 B1
`7/2001 Schuster et al.
`6,267,155 B1
`7/2001 Parks et al.
`6,275,650 B1
`8, 2001 Lambert
`6,276,347 B1
`8, 2001 Hunt
`6,284.525 B1
`9, 2001 Mathies et al.
`6,288,360 B1
`9, 2001 Beste
`6,290,685 B1
`9/2001 Insley et al.
`6,294,204 B1
`9/2001 Rössling et al.
`6,295,986 B1 10/2001 Patel et al.
`6,318,361 B1
`1 1/2001 Sosiak
`6,491,233 B1
`12/2002 Nichols ...................... 239,128
`6,501,052 B1* 12/2002 Cox et al. ...
`... 219,486
`6,516,796 B1* 2/2003 Cox et al. .............. 128.200.23
`6,557.552 B1* 5/2003 Cox et al. ......
`... 128, 20327
`6,766,220 B1* 7/2004 McRae et al. .............. TOO.266
`6,772,757 B1 * 8/2004 Sprinkel, Jr. ........... 128,203.26
`6,923,179 B1* 8/2005 Gupta et al. ........... 128.20317
`2001 OO32647 A1
`10, 2001 Schuster et al.
`
`
`
`FOREIGN PATENT DOCUMENTS
`
`BE
`BE
`DE
`EP
`EP
`FR
`HU
`HU
`HU
`HU
`HU
`WO
`WO
`WO
`WO
`
`9, 1928
`354004 A
`9, 1928
`354094
`4f1958
`103.6470
`3, 1990
`358114
`3, 1995
`6428O2
`10, 1929
`667979
`2, 1976
`168128
`4f1993
`168128
`4f1993
`2O7457
`6, 1994
`P95034-0
`4f1999
`216121
`5, 1994
`WO 94,09842
`WO 97/49441 A 12/1997
`98.17131
`4f1998
`WO 98,17131 A
`4f1998
`
`OTHER PUBLICATIONS
`Supplementary Partial European Search Report for Applin. No.
`999520.0034-2310/US9924080 dated Jun. 22, 2004.
`Barry, P.W. et al., “In Vitro Comparison of the Amount of
`Salbutamol Availiable for Inhalation From Different Formulations
`Used with Different Spacer Devices” Eur Respir J 1997: 10:
`1345-1348.
`Hindle, Michael et al. “High Efficiency Aerosol Production Using
`the Capillary Aerosol Generator' PharmSci 1998; 1: (1: Suppl)
`S211.
`Hindle, Michael et al., “High Efficiency Fine Particle Generation
`Using Novel Condensation Technology”. Respiratory Drug Deliv
`
`ery VI (eds Dalby, R.N., Byron, P.R. & Farr, S.J.) Interpharm Press,
`Buffalo Grove, IL 1998 pp. 97-102.
`Hou, Shuguang et al. Solution Stability of Budendonide in Novel
`Aerosol Formations Abstract No. 2582, Solid State Physical Phar
`macy, Nov. 17, 1998, p. S-307.
`Morén, Folke “Drug Deposition of Pressurized Inhalation Aerosols
`I. Influence of Actuator Tube Design' AB Draco (Subsidiary of AB
`Astra, Sweden) Research and Development Laboratories Pack,
`S-221 01 Lund (Sweden), International Journal of Pharmaceutrics,
`1 (1978) 205-212.
`Newman, Stephen P. et al. “Deposition of Pressurized Suspension
`Aerosols Inhaled Through Extension Devices.” Am Rev. Respir
`Dis 1981; 124:317-320
`Roth, G. et al. High Performance Liquid Chromatographic Deter
`mination of Epimers, Impurties, and Content of the Glucocorticoid
`Budesonide and Preparation of Primary Standard, Journal of Phar
`maceutical Sciences, vol. 69, No. 7, pp. 766-770, Jul. 1980.
`Kousaka et al., Generation of Aerosol Particles by Boiling of
`Suspensions, Aerosol Science & Technology, 1994, pp. 236-240.
`Stimuli to the Revision process, Pharmocopeial Forum, May-Jun.
`1994, pp. 7477-7505, vol. 20, No. 3.
`European Communication Pursuant to Article 96(2) EPC dated Dec.
`1, 2004 for Application No. 99 952 003.4-2310.
`European Communication Pursuant to Article 96(2) EPC dated Sep.
`15, 2005 for Application No. 99 952 0034-2310.
`* cited by examiner
`Primary Examiner Henry Bennett
`Assistant Examiner Nihir Patel
`(74) Attorney, Agent, or Firm—Buchanan Ingersoll &
`Rooney PC
`
`(57)
`
`ABSTRACT
`
`An aerosol generator includes a flow passage having an inlet
`and an outlet, a heater arranged relative to the flow passage
`for heating the flow passage, a source of material to be
`volatilized in communication with the inlet of the flow
`passage, a valve to open and close communication between
`the Source of material and the inlet of the flow passage, and
`a pressurization arrangement for causing material in the
`Source of material to be introduced into the flow passage
`when the valve is in an open position. The aerosol generator
`further includes a source of power for operating the heater
`and the valve, and a control device for controlling Supply of
`power from the source of power to the heater and the valve.
`A metering device in an inhaler includes a pressurized
`Source of medicated fluid and a metering chamber config
`ured to deliver a predetermined volume of fluid to a heated
`flow passage in the inhaler. The metering chamber can be
`part of a rotary valve having a bore and a displacement
`member moveable within the bore from a first position
`where the fluid is loaded into the bore to a second position
`where the predetermined volume is ejected out of the bore.
`Another metering chamber has an elastic portion of a
`delivery passage in fluid communication with the pressur
`ized source of liquid and the elastic portion of the delivery
`passage is deformed to eject the predetermined Volume.
`
`11 Claims, 15 Drawing Sheets
`
`Philip Morris Products, S.A.
`Exhibit 1026
`Page 003
`
`

`

`U.S. Patent
`
`Oct. 10, 2006
`
`Sheet 1 of 15
`
`US 7,117,867 B2
`
`
`
`Philip Morris Products, S.A.
`Exhibit 1026
`Page 004
`
`

`

`Philip Morris Products, S.A.
`Exhibit 1026
`Page 005
`
`

`

`U.S. Patent
`
`Oct. 10, 2006
`
`Sheet 3 of 15
`
`US 7,117,867 B2
`
`
`
`S
`
`S
`R
`
`s
`
`Philip Morris Products, S.A.
`Exhibit 1026
`Page 006
`
`

`

`U.S. Patent
`
`Oct. 10, 2006
`
`Sheet 4 of 15
`
`US 7,117,867 B2
`
`
`
`Philip Morris Products, S.A.
`Exhibit 1026
`Page 007
`
`

`

`U.S. Patent
`
`Oct. 10, 2006
`
`Sheet 5 Of 15
`
`US 7,117,867 B2
`
`97
`
`
`
`
`
`
`
`
`
`
`
`LEOEKSGOED,
`
`979
`
`Philip Morris Products, S.A.
`Exhibit 1026
`Page 008
`
`

`

`U.S. Patent
`
`US 7,117,867 B2
`
`
`
`
`
`•
`
`
`
`345b
`FIG. 6A
`
`FG, 6C
`
`Philip Morris Products, S.A.
`Exhibit 1026
`Page 009
`
`

`

`U.S. Patent
`
`Oct. 10, 2006
`
`Sheet 7 Of 15
`
`US 7,117,867 B2
`
`429 s N 451
`
`
`
`408
`
`403
`
`401 N-N
`
`
`
`
`
`
`
`
`
`
`
`
`
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`N
`405
`N
`&SNE
`E.R. 2). 419, 2.
`
`
`
`06
`4.
`
`Philip Morris Products, S.A.
`Exhibit 1026
`Page 010
`
`

`

`Philip Morris Products, S.A.
`Exhibit 1026
`Page 011
`
`

`

`U.S. Patent
`
`Oct. 10, 2006
`
`Sheet 9 Of 15
`
`US 7,117,867 B2
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`
`
`FIG.9
`
`Philip Morris Products, S.A.
`Exhibit 1026
`Page 012
`
`

`

`U.S. Patent
`
`Oct. 10, 2006
`
`Sheet 10 of 15
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`US 7,117,867 B2
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`
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`Philip Morris Products, S.A.
`Exhibit 1026
`Page 013
`
`

`

`U.S. Patent
`
`Oct. 10, 2006
`
`Sheet 11 of 15
`
`US 7,117,867 B2
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`(
`
`S
`
`(a)
`
`s
`
`Philip Morris Products, S.A.
`Exhibit 1026
`Page 014
`
`

`

`U.S. Patent
`
`Oct. 10, 2006
`
`Sheet 12 of 15
`
`US 7,117,867 B2
`
`
`
`O)
`CO
`qr
`
`Philip Morris Products, S.A.
`Exhibit 1026
`Page 015
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`

`

`U.S. Patent
`
`Oct. 10, 2006
`
`Sheet 13 of 15
`
`US 7,117,867 B2
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`3.
`
`(
`
`S
`
`N
`
`S.
`
`Philip Morris Products, S.A.
`Exhibit 1026
`Page 016
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`

`

`U.S. Patent
`
`Oct. 10, 2006
`
`Sheet 14 of 15
`
`US 7,117,867 B2
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`
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`Philip Morris Products, S.A.
`Exhibit 1026
`Page 017
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`

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`U.S. Patent
`
`Oct. 10, 2006
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`Sheet 15 Of 15
`
`US 7,117,867 B2
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`
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`Philip Morris Products, S.A.
`Exhibit 1026
`Page 018
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`

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`US 7,117,867 B2
`
`1.
`AEROSOL GENERATOR AND METHODS OF
`MAKING AND USING AN AEROSOL
`GENERATOR
`
`2
`cament so that the propellant and the medicament can be
`inhaled by the user. Since the medicament is propelled by
`the propellant, such propellant-based arrangements are well
`suited for those who might have difficulty inhaling. None
`theless, aerosols generated by propellant-based arrange
`ments have particles that are too large to ensure deep lung
`penetration.
`In propellant-based arrangements, however, a medica
`ment may not be properly delivered to the patient’s lungs
`when it is necessary for the user to time the depression of an
`actuator Such as a button with inhalation. Moreover, Such
`arrangements tend to be poorly Suited for delivery of mate
`rials in large quantities. Although propellant-based aerosol
`generators have wide application for uses such as antiper
`spirant and deodorant sprays and spray paint, their use is
`often limited because of the well-known adverse environ
`mental effects of CFCs and methylchloroform, which are
`among the most popular propellants used in aerosol genera
`tors of this type.
`In drug delivery applications, it is typically desirable to
`provide an aerosol having average mass median particle
`diameters of less than 2 microns to facilitate deep lung
`penetration. Most known aerosol generators are incapable of
`generating aerosols having average mass median particle
`diameters less than 2 to 4 microns. It is also desirable, in
`certain drug delivery applications, to deliver medicaments at
`high flow rates, e.g., above 1 milligram per second. Most
`known aerosol generators Suited for drug delivery are inca
`pable of delivering such high flow rates in the 0.2 to 2.0
`micron size range.
`U.S. Pat. No. 5,743,251, which is hereby incorporated by
`reference in its entirety, discloses an aerosol generator, along
`with certain principles of operation and materials used in an
`aerosol generator, as well as a method of producing an
`aerosol, and an aerosol. The aerosol generator disclosed
`according to the 251 patent is a significant improvement
`over earlier aerosol generators, such as those used as inhaler
`devices. It is desirable to produce an aerosol generator that
`is portable and easy to use.
`According to one aspect of the present invention, an
`aerosol generator includes a flow passage such as a tube
`having an inlet and an outlet, a heater arranged relative to the
`flow passage for heating at least a portion of the flow
`passage, a source of material to be volatilized, the inlet of the
`flow passage being in communication with the source of
`material, and a valve operatively located between the source
`of material and the flow passage, the valve being openable
`and closeable to open and close communication between the
`Source and the outlet of the flow passage. A pressurization
`arrangement is provided for causing material in the source of
`material to be introduced into the flow passage from the
`Source of material when the valve is in an open position. A
`source of power is provided for operating the heater and for
`the valve, and a control device is provided for controlling
`supply of power from the source of power to the heater and
`the valve.
`According to a further aspect of the present invention, a
`method of making an aerosol generator is disclosed. Accord
`ing to the method, a heater is arranged relative to a flow
`passage for heating of the flow passage, the flow passage
`having an inlet and an outlet. The inlet of the flow passage
`is connected to a source of material to be volatilized. An
`openable and closeable valve is provided between the source
`of material and the flow passage. A pressurization arrange
`ment is provided for causing material in the source of
`material to be introduced into the flow passage from the
`Source of material when the valve is in an open position. The
`
`This application is a continuation of application Ser. No.
`10/247,776, filed on Sep. 20, 2002 ABN, which is a con
`tinuation of application Ser. No. 0/479.597, filed on Jan. 7,
`2000 now U.S. Pat. No. 6,516,796, which is a continuation
`of PCT/US99/24080, filed Oct. 14, 1999, which is a con
`tinuation of application Ser. No. 09/172,023, filed Oct. 14,
`1998 now U.S. Pat. No. 6,234,167.
`
`5
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`BACKGROUND AND SUMMARY OF THE
`INVENTION
`
`15
`
`The present invention relates generally to aerosol genera
`tors and, more particularly, to aerosol generators able to
`generate aerosols without compressed gas propellants and
`methods of making and using Such aerosol generators. The
`present invention also relates generally to metering valves in
`inhalers and, more particularly, to metering valves which
`deliver a predetermined volume in inhalers including aerosol
`generators able to generate aerosols without compressed gas
`propellants.
`Aerosols are useful in a wide variety of applications. For
`example, it is often desirable to treat respiratory ailments
`with, or deliver drugs by means of aerosol sprays of finely
`divided particles of liquid and/or Solid, e.g., powder, medi
`caments, etc., which are inhaled into a patient’s lungs.
`Aerosols are also used for purposes Such as providing
`desired scents to rooms, applying scents on the skin, and
`delivering paint and lubricant.
`Various techniques are known for generating aerosols. For
`example, U.S. Pat. Nos. 4,811,731 and 4,627,432 both
`disclose devices for administering medicaments to patients
`in which a capsule is pierced by a pin to release a medica
`ment in powder form. A user then inhales the released
`medicament through an opening in the device. While Such
`devices may be acceptable for use in delivering medica
`ments in powder form, they are not suited to delivering
`medicaments in liquid form. The devices are also, of course,
`not well-suited to delivery of medicaments to persons who
`might have difficulty in generating a Sufficient flow of air
`through the device to properly inhale the medicaments. Such
`as asthma sufferers. The devices are also not suited for
`delivery of materials in applications other than medicament
`delivery.
`Another well-known technique for generating an aerosol
`involves the use of a manually operated pump which draws
`liquid from a reservoir and forces it through a small nozzle
`opening to form a fine spray. A disadvantage of Such aerosol
`generators, at least in medicament delivery applications, is
`the difficulty of properly synchronizing inhalation with
`pumping. More importantly, however, because such aerosol
`generators tend to produce particles of large size, their use
`as inhalers is compromised because large particles tend to
`not penetrate deep into the lungs.
`One of the more popular techniques for generating an
`aerosol including liquid or powderparticles involves the use
`of a compressed propellant, often containing a chloro
`fluoro-carbon (CFC) or methylchloroform, to entrain a
`material, usually by the Venturi principle. For example,
`inhalers containing compressed propellants such as com
`pressed gas for entraining a medicament are often operated
`by depressing a button to release a short charge of the
`compressed propellant. The propellant entrains the medica
`ment as the propellant flows over a reservoir of the medi
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`Philip Morris Products, S.A.
`Exhibit 1026
`Page 019
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`

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`US 7,117,867 B2
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`3
`valve is connected to a source of power for opening and
`closing the valve. The heater is connected to the source of
`power. The source of power is connected to a control device
`for controlling a Supply of power from the source of power
`to the heater and the valve.
`According to yet another aspect of the present invention,
`a method of generating an aerosol is disclosed. According to
`the method, a first signal indicative of a users intention to
`generate an aerosol, is generated and sent to a control device.
`With the control device and responsive to the first signal, a
`second signal is sent to a source of power to cause the Source
`of power to open an openable and closeable valve, the valve
`being disposed between a source of material to be volatilized
`and a flow passage, opening of the valve permitting material
`from the source of material to flow from the source of
`material and into the flow passage. Material from the Source
`of material is thus caused to flow from the source of material
`and into the flow passage. With the control device and
`responsive to the first signal, a third signal is sent to the
`Source of power to Supply power to a heater disposed
`relative to the flow passage to heat the flow passage.
`Material from the source of material is heated in the flow
`passage with the heater to a vaporization temperature Such
`that the material volatilizes and expands out of an outlet of
`the flow passage.
`25
`The present invention also provides a metering device in
`an inhaler having a pressurized source of medicated fluid
`and a metering chamber in fluid communication with the
`pressurized source of fluid. The metering chamber is con
`figured to deliver a predetermined volume of fluid to a
`heated flow passage in an inhaler.
`In accordance with one embodiment of the metering
`device, the metering chamber is a rotary valve including a
`bore and a displacement member located within the bore.
`The displacement member is movable from a first position
`where the fluid is loaded into a load portion of the bore to
`a second position where the predetermined volume of fluid
`is ejected out of the bore.
`In accordance with another embodiment of the metering
`device, the metering device includes a delivery passage
`including an elastic portion. The metering chamber is
`located in the elastic portion of the delivery passage. The
`elastic portion of the delivery passage is compressed to eject
`a predetermined Volume of liquid.
`In accordance with another aspect of the invention, the
`inhaler preferably includes an aerosol generator wherein a
`flow passage has an inlet and an outlet and a pressurized
`source of fluid, a heater is arranged relative to the flow
`passage for heating at least a portion of the flow passage; and
`a metering chamber is in fluid communication with the
`pressurized source of fluid and is configured to deliver a
`predetermined Volume to the flow passage.
`In accordance with another aspect of the invention, a
`method of dispensing a predetermined Volume of medicated
`fluid in an inhaler is provided wherein the inhaler includes
`a metering device having a pressurized source of fluid which
`is in fluid communication with a metering chamber. Accord
`ing to the method, the metering chamber is filled with fluid
`from the pressurized source and a predetermined Volume of
`the fluid is ejected from the metering chamber into a heated
`flow passage.
`
`4
`tion in conjunction with the drawings in which like numerals
`indicate similar elements and in which:
`FIG. 1 is a schematic, partially broken, side view of an
`aerosol generator according to an embodiment of the present
`invention;
`FIG. 2 is a logic diagram of powered components of an
`aerosol generator according to an embodiment of the present
`invention;
`FIG. 3 is a schematic, partially broken, side view of an
`aerosol generator according to a second embodiment of the
`present invention;
`FIG. 4 is a schematic, partially broken, side view of an
`aerosol generator according to a third embodiment of the
`present invention;
`FIG. 5 is a schematic, partially broken, side view of an
`aerosol generator according to a fourth embodiment of the
`present invention;
`FIGS. 6A-6C show steps according to a method, accord
`ing to a further aspect of the present invention, of manu
`facturing an aerosol generator according to the fifth embodi
`ment of the present invention.
`FIG. 7 is a schematic cut-away view of a metering device
`according to the present invention;
`FIG. 8 is a schematic view of a metering device according
`to the present invention;
`FIG. 9 is a front schematic cut-away view of the metering
`device shown in FIG. 7:
`FIG. 10 is a side schematic cut-away view of the metering
`device shown in FIG. 8:
`FIGS. 11A-11C are schematic cut-away views of another
`metering device according to the present invention;
`FIG. 12 is a front schematic cut-away view of a modified
`metering device according to the present invention;
`FIG. 13 is a side schematic cut-away view of a portion of
`the delivery passage shown in FIG. 12.
`
`DETAILED DESCRIPTION
`
`An aerosol generator 21 according to the present inven
`tion is shown in FIG. 1. The principles of operation of the
`aerosol generator 21 and, where applicable, materials used
`in the aerosol generator are preferably similar to the prin
`ciples of operation and materials used in the aerosol gen
`erator disclosed in U.S. Pat. No. 5,743,251, which is hereby
`incorporated by reference in its entirety.
`A preferred application for the aerosol generator 21 is as
`an inhaler device. Such as an inhaler for medicaments. Such
`as asthma medication and pain killers or any other thera
`peutic agents for treatment of a bodily condition. The
`aerosol generator 21 preferably includes a first component
`23, which preferably includes, for example, the material to
`be turned into an aerosol and which is preferably disposable
`after one or a predetermined plurality of uses, removably
`attached to a second component 25, which preferably
`includes, for example, power source and logic circuitry
`structures and which is preferably permanent in the sense
`that it is reusable with successive ones of the first compo
`nents. The first and second components 23 and 25 can be,
`attachable to one another in end to end or side by side
`relationships. If desired or necessary, however, the aerosol
`generator can be a one-piece device.
`The first component 23 preferably includes a flow passage
`in the form of a tube 27 having a first and a second end 29.
`31, and a heater 33 arranged relative to the tube for heating
`the tube. A valve 35 is provided either on the tube 27 or
`between the second end 31 of the tube and a source 37 of
`material, the valve preferably being openable and closeable
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`BRIEF DESCRIPTION OF THE DRAWINGS
`
`The features and advantages of the present invention are
`well understood by reading the following detailed descrip
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`Philip Morris Products, S.A.
`Exhibit 1026
`Page 020
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`

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`US 7,117,867 B2
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`to open and close communication between the first end 29 of
`the tube and the source of material. The valve 35 may define
`the second end 31 of the tube. The valve 35 is preferably
`electronically openable and closeable, preferably a solenoid
`type valve. The first component 23 preferably further
`includes the source 37 of material to be volatilized. The first
`component 23 preferably also includes a pressurization
`arrangement 39 for causing material in the source 37 of
`material to be introduced into the tube 27 from the source of
`material when the valve 35 is in an open position.
`The second component 25 is preferably attachable and
`detachable to the first component 23 and includes a source
`41 of power for the heater 33 and for the valve 35, and a
`control device 43, Such as a microchip, for controlling
`supply of power from the source of power to the heater and
`the valve. The source 41 of power is preferably a battery,
`more preferably a rechargeable battery, however, the source
`of power may, if desired or necessary, be a non-depleting
`Source of power. Such as a conventional power line. Inter
`national Publication No. WO 98/17131 discloses a power
`controller and a method of operating an electrical Smoking
`system that discloses a power source and a control device,
`particularly for heaters, the principles of operation and
`features of which are transferrable to the present invention,
`and is hereby incorporated by reference.
`In WO 98/17 131 power is applied to a heater element in
`accordance with a predetermined series of phases with each
`phase assigned different target total energies per phase and
`predetermined time periods for each phase Such that a heat
`treatment event is achieved. In WO 98/17 131 the controller
`is configured to modulate power in each phase so that the
`target energies are maintained irrespective of externalities
`such as battery voltage or the like. Preferably all liquid
`entering the flow passage formed by the tube 27 is volatil
`ized before being discharged from the tube 27. Power
`modulation within one or more phases of a power cycle as
`described above can optionally be used to assure that such
`Volatilization occurs consistently over a broad range of
`battery Voltages such as those encountered along a battery
`40
`discharge cycle.
`General operation of the aerosol generator 21 involves a
`user providing a signal. Such as by compressing a button or
`performing some other action Such as inhaling near the first
`end 29 of the tube 27 to actuate a flow