IIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIII
`US009604008B2
`
`(12' United States Patent
`Veasey et al.
`
`(Io) Patent No. :
`(45) Date of Patent:
`
`US 9,604,008 B2
`*Mar. 28, 2017
`
`(54) DRIVE MECHANISMS SUITABLE FOR USE
`IN DRUG DELIVERY DEVICES
`
`(71) Applicant: SANOFI-AVENTIS DEUTSCHLAND
`GMBH, Frankfurt
`am Main (DE)
`
`(72)
`
`Inventors: Robert Frederick Veasey,
`(GB); Robert Perkins,
`Warwickshire
`(GB); David Aubrey
`Warwickshire
`Plumptre, Worcestershire
`(GB)
`
`(73) Assignee:
`
`Sanofi-Aventis Deutschland GmbH,
`am Main (DE)
`Frankfurt
`
`(58) Field of Classification Search
`CPC ................ A61M 5/24; A61M 5/31533; A61M
`5/31535; A61M 5/31536; A61M 5/31541;
`(Continued)
`
`(56)
`
`References Cited
`
`U.S. PATENT DOCUMENTS
`
`533,575 A
`2,444, 570 A
`
`2/1895 Wilkens
`7/1948 Lawrence et al.
`(Continued)
`
`( * ) Notice:
`
`the term of this
`Subject to any disclaimer,
`is extended or adjusted under 35
`patent
`U.S.C. 154(b) by 164 days.
`to a terminal
`is subject
`This patent
`claimer.
`
`dis-
`
`DE
`EP
`
`FOREIGN PATENT DOCUMENTS
`
`3609555
`295075
`
`9/1987
`12/19gg
`(Continued)
`
`OTHER PUBLICATIONS
`
`(21) Appl. No. : 14/319,3SS
`
`(22)
`
`Filed:
`
`Jun. 30, 2014
`
`(65)
`
`Prior Publication Data
`US 2014/0316348 Al
`Oct. 23, 2014
`Related U.S. Application Data
`(63) Continuation of application No. 12/941, 702, filed on
`Nov. 8, 2010, now Pat. No. 9,028,454, which is a
`(Continued)
`
`(30)
`
`Foreign Application Priority Data
`
`Mar. 3, 2003
`
`(GB)
`
`0304822.0
`
`(51)
`
`Int. Cl.
`A 61/If 5/315
`A 61/If 5/24
`
`(2006.01)
`(2006.01)
`(Continued)
`
`(52) U.S. Cl.
`CPC .......... A61/If 5/31551 (2013.01); A61/If 5/24
`(2013.01); A61/If 5/3157 (2013.01);
`(Continued)
`
`Reissue U.S. Appl. No. 10/442, 855, "Injection Syringe",
`filed May
`21, 2003, including
`as-filed specification,
`abstract,
`and
`drawings,
`claims, as well as the reissue declaration.
`(Continued)
`
`Primary Examiner
`Andrew Gilbert
`(74) Attorney, Agent, or Firm
`McDonnell Boehnen
`Hulbert & Berghofi' LLP
`
`ABSTRACT
`(57)
`A drive mechanism suitable for use in drug delivery devices
`is disclosed. The drive mechanism may be used with injec-
`such as those permitting
`tor-type drug delivery devices,
`a
`the delivery dose. The drive mechanism may
`user
`to set
`a dose dial sleeve, and a drive sleeve. A
`include a housing,
`clutch is configured to permit rotation of the drive sleeve and
`to the housing when the
`the dose dial sleeve with respect
`dose dial sleeve and drive sleeve are coupled through
`the
`clutch. Conversely, when the dose dial
`sleeve and drive
`rotation of the dose dial
`sleeve are in a de-coupled
`state,
`to the housing is permitted and rotation
`sleeve with respect
`of the drive sleeve with respect
`to the housing is prevented.
`In the de-coupled state, axial movement of the drive sleeve
`(Continued)
`
`83
`84
`
`85
`-39
`47
`
`37
`
`~ 24
`-35
`—30
`
`105
`19
`40
`
`16
`
`10
`
`7562—64—
`
`76
`44
`60
`70
`4
`20
`50
`
`34
`36
`
`3218~
`
`22
`
`14
`
`1
`
`12
`
`PFIZER, INC. v. SANOFI-AVENTIS DEUTSCHLAND GMBH
`
`Ex. 1005, p. 1 of 26
`
`

`

`6/1994
`6/1994
`7/1994
`7/1994
`12/1994
`1/1995
`1/1995
`8/1995
`8/1995
`9/1995
`12/1995
`1/1996
`2/1996
`4/1996
`8/1996
`
`8/1996
`8/1996
`8/1996
`8/1996
`12/1996
`
`12/1996
`1/1997
`2/1997
`3/1997
`5/1997
`
`et al.
`Athayde
`Haber et al.
`Woo drutf
`Rex et al.
`Michel et al.
`Wadman et al.
`Michel
`Guiliano et al.
`Haak et al.
`Bacon
`Bitdinger et al.
`Gabriel et al.
`et al.
`Athayde
`Pawelka et al.
`... ... ... ... ... A61M 5/31551
`Harris
`604/208
`
`Galli
`Brace
`Townsend
`Giambattista
`.. ... ... ... A61M 5/31551
`Chanoch
`222/309
`
`Pawelka
`Gabriel
`Neill
`Mikkelson
`Petersen
`
`.. ... ... ... A61M 5/31551
`222/309
`
`A61M 5/20
`604/135
`
`7/1997 Kersey
`10/1997 Chanoch
`10/1997 Hjertman
`
`10/1997
`11/1997
`11/1997
`12/1997
`1/1998
`2/1998
`3/1998
`3/1998
`3/1998
`4/1998
`5/1998
`10/1998
`10/1998
`12/1998
`3/1999
`4/1999
`7/1999
`7/1999
`8/1999
`9/1999
`9/1999
`9/1999
`9/1999
`10/1999
`10/1999
`11/1999
`11/1999
`12/1999
`12/1999
`12/1999
`
`Ford et al.
`Shanely et al.
`Chanoch
`Hansen et al.
`Olive et al.
`Bagshawe et al.
`Chanoch et al.
`Castellano et al.
`Levander
`Sams
`Manic om
`Yamagata
`Chanoch
`Olive et al.
`Pommer et al.
`Jensen et al.
`Bendek et al.
`Poulsen et al.
`et al.
`Burroughs
`Hansen et al.
`Steengaard et al.
`Poulsen
`Bendek et al.
`Walters et al.
`Nielsen et al.
`Hansen
`Mikkelsen
`Burroughs
`Ljunggren
`Steenfeldt-Jensen
`
`et al.
`
`A61M 5/31551
`604/207
`
`et al.
`
`et al.
`
`1/2000
`3/2000
`3/2000
`4/2000
`5/2000
`6/2000
`7/2000
`7/2000
`8/2000
`8/2000
`10/2000
`11/2000
`2/2001
`4/2001
`4/2001
`
`Buch-Rasmussen
`Rockley
`Rasmussen
`Gabriel
`Michel
`Hansen
`Umbaugh
`Kirchhofer et al.
`Walters
`Klitgaard et al.
`Pitcher et al.
`DiBiasi et al.
`Kirchhofer et al.
`et al.
`Burroughs
`. ... ... ... ... A61M 5/31551
`Walters
`604/208
`
`US 9,604,008 B2
`Page 2
`
`AAAAAAAAAAAAAAA AAAAA AAAAA AAA AAAAAAAAAAAAAAAAAAAAAAAAAAAAAA AAAAAAAAAAAAB
`
`l
`Bl
`Bl *
`
`5,318,540
`5,320,609
`5,328,486
`5,331,954
`5,370,629
`5,380,297
`5,383,865
`5,440,976
`5,445,606
`5,447, 150
`5,478,316
`5,480,387
`5,492,534
`5,505,704
`5,545, 147
`
`5,546,932
`5,547, 131
`5,549,574
`5,549,575
`5,582,598
`
`5,584,815
`5,591,136
`5,599,314
`5,611,783
`5,626,566
`
`5,645,052
`5,674,204
`5,679, 111
`
`5,681,285
`5,685,864
`5,688,251
`5,693,027
`5,709,662
`5,716,990
`5,725,508
`5,728,074
`5,728,075
`5,743,889
`5,755,692
`5,823,998
`5,827,232
`5,843,036
`5,882,718
`5,898,028
`5,921,966
`5,928,201
`5,938,642
`5,947,934
`5,951,530
`5,954,689
`5,957,896
`5,961,495
`5,961,496
`5,980,491
`5,984,900
`6,001,089
`6,003,736
`6,004,297
`
`6,010,485
`6,033,376
`6,033,377
`6,048,336
`6,059,755
`6,074,372
`6,083, 197
`6,086,567
`6,096,010
`6, 110,149
`6, 129,080
`6, 146,361
`6, 193,698
`6,221,046
`6,221,053
`
`force in a longitudinal
`transfers
`drug delivery device.
`
`direction for actuation of a
`
`19 Claims, 13 Drawing Sheets
`
`Related U.S. Application Data
`continuation of application No. 12/320, 189, filed on
`Jan. 21, 2009, now Pat. No. 7,850,662, which is a
`continuation of application No. 11/520, 598, filed on
`Sep. 14, 2006, now Pat. No. 7,935,088, which is a
`continuation of application No. 10/790, 866, filed on
`Mar. 3, 2004, now abandoned.
`
`(51)
`
`(2006.01)
`(2006.01)
`
`Int. Cl.
`261M 5/32
`361M 5/31
`(52) U.S. Cl.
`CPC .... 261M 5/31528 (2013.01); 261M 5/31533
`(2013.01); 261M 5/31535 (2013.01); 261M
`5/31536 (2013.01); 261M 5/31541 (2013.01);
`261M 5/31546 (2013.01); 261M 5/31563
`(2013.01); 261M 5/31568 (2013.01); 261M
`5/31585 (2013.01); 261M 5/31593 (2013.01);
`261M 5/32 (2013.01); 361M 5/3156
`(2013.01); 361M 5/31565 (2013.01); 361M
`5/31575 (2013.01); 361M 5/31578 (2013.01);
`361M 2005/2407 (2013.01); 361M 2005/3126
`(2013.01); 361M 2205/581 (2013.01); 361M
`2205/582 (2013.01)
`
`(58) Field of Classification Search
`CPC .......... A61M 5/31551; A61M 5/31565; A61M
`5/31578
`See application file for complete search history.
`
`(56)
`
`References Cited
`
`U.S. PATENT DOCUMENTS
`
`2,717,597 A
`2,722,931 A
`3,815,785 A
`4,470,317 A
`4,498,904 A
`4,568,335 A
`4,585,439 A
`4,592,745 A
`4,833,379 A
`4,863,072 A
`4,865,591 A
`4,883,472 A
`4,919,596 A
`4,936,833 A
`4,973,318 A
`4,994,033 A
`5,017,190 A
`5,030,209 A
`5, 112,317 A
`5,207,752 A
`5,226, 895 A
`5,246,417 A
`5,257,987 A
`5,271,527 A
`5,279,585 A
`5,279,586 A
`5,281,198 A
`5,284,480 A
`5,304, 152 A
`5,308,340 A
`5,314,412 A
`
`9/1955
`11/1955
`6/1974
`9/1984
`2/1985
`2/1986
`4/1986
`6/1986
`5/1989
`9/1989
`9/1989
`11/1989
`4/1990
`6/1990
`11/1990
`2/1991
`5/1991
`7/1991
`5/1992
`5/1993
`7/1993
`9/1993
`11/1993
`12/1993
`1/1994
`1/1994
`1/1994
`2/1994
`4/1994
`5/1994
`5/1994
`
`Hein, Jr.
`May
`Gilmont
`et al.
`Sabloewski
`Turner et al.
`Updike et al.
`Michel
`Rex et al.
`Kaibel et al.
`Perler
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`Michel
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`et al.
`Athayde
`Haber et al.
`Balkwill
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`Haber et al.
`Porter et al.
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`Harris
`Rex
`
`PFIZER, INC. v. SANOFI-AVENTIS DEUTSCHLAND GMBH
`
`Ex. 1005, p. 2 of 26
`
`

`

`US 9,604,008 B2
`Page 3
`
`(56)
`
`References Cited
`
`U.S. PATENT DOCUMENTS
`
`Smedegaard
`Steenfeldt-Jensen
`Jensen et al.
`Giambattista
`
`et al.
`
`.. ... A61M 5/31551
`604/207
`
`Thielen et al.
`Ford et al.
`Mikkelsen et al.
`Klitmose et al.
`Strowe et al.
`Kirchhofer et al.
`Hearst et al.
`Schoenfeld et al.
`et al.
`Ljunggreen
`Klitgaard
`Jensen et al.
`Poulsen et al.
`Klitgaard et al.
`Kirchhofer et al.
`Munk et al.
`Steenfeldt-Jensen
`Larsen et al.
`Buch Rasmussen
`Poulsen et al.
`. ... ... ... A61M 5/31525
`Klitgaard
`604/1 g1
`
`et al.
`
`et al.
`
`Larsen
`Munk
`Moiler
`Hansen et al.
`Larsen
`Munk et al.
`Duirs
`Klitmose et al.
`Madsen et al.
`Sams
`Enggaard
`et al.
`Giambattista
`.. ... ... ... A61M 5/31551
`Bush, Jr.
`604/187
`
`Miller et al.
`Larsen et al.
`et al.
`Wimpenny
`Veasey et al.
`Moiler et al.
`et al
`Skyggebiera
`Bendek et al.
`Hansen et al.
`Diller
`... .... ... ...
`
`A61M 5/31566
`604/207
`A61M 5/24
`604/211
`
`6,231,540
`6,235,004
`6,248,090
`6,248,095
`
`6,258,062
`6,269,340
`6,277,097
`6,277,09g
`6,277,099
`6,277, 101
`6,281,225
`6,283,941
`6,287,283
`6,302,869
`6,312,413
`6,340,357
`6,379,339
`6,383,167
`6,514,230
`6,547,763
`6,547,764
`6,562,011
`6,569, 126
`6,5 g2,404
`
`6,605,067
`6,613,019
`6,663,602
`6,692,472
`6,716,19g
`6,726,661
`6,770,2gg
`6,796,970
`6,893,415
`6,899,69g
`6,899,699
`6,932,794
`6,936,032
`
`6,945,961
`7,008,399
`7,090,662
`7,094,221
`7, 104,972
`7, 133,329
`7, 169,132
`7, 175,055
`7, 195,616
`
`7,241,27g
`
`Bl
`Bl
`Bl
`Bl *
`
`Bl
`Bl
`Bl
`Bl
`Bl
`Bl
`Bl
`Bl
`Bl
`Bl
`Bl
`Bl
`Bl
`B2
`Bl
`B2
`B2
`Bl
`Bl
`Bl *
`
`Bl
`B2
`B2
`B2
`B2
`B2
`B2
`Bl
`B2
`B2
`B2
`B2
`Bl *
`
`B2
`B2
`B2
`B2
`B2
`B2
`B2
`B2
`B2*
`
`B2*
`
`5/2001
`5/2001
`6/2001
`6/2001
`
`7/2001
`7/2001
`g/2001
`g/2001
`g/2001
`g/2001
`g/2001
`9/2001
`9/2001
`10/2001
`11/2001
`1/2002
`4/2002
`5/2002
`2/2003
`4/2003
`4/2003
`5/2003
`5/2003
`6/2003
`
`g/2003
`9/2003
`12/2003
`2/2004
`4/2004
`4/2004
`g/2004
`9/2004
`5/2005
`5/2005
`5/2005
`g/2005
`g/2005
`
`9/2005
`3/2006
`g/2006
`g/2006
`9/2006
`11/2006
`1/2007
`2/2007
`3/2007
`
`7,291,132
`7,316,670
`7,361,161
`
`B2
`B2
`B2*
`
`11/2007
`1/200 g
`4/200 g
`
`7,553,299
`7,736,343
`
`B2
`B2*
`
`6/2009
`6/2010
`
`7/2007
`
`Moiler
`
`DeRuntz et al.
`Graf et al.
`... ... ... ... A61M 5/31551
`Bainton
`604/207
`
`Veasey et al.
`.. ... ... ... A61M 5/31525
`Marshall
`604/207
`
`7,771,400
`7,850,662
`
`B2
`B2*
`
`7,905,867
`
`7,91g,g33
`7,935,0gg
`
`g,021,345
`
`B2*
`
`B2
`B2*
`
`B2*
`
`g/2010
`12/2010
`
`Nielsen
`Veasey . ..
`
`3/2011
`
`Veasey
`
`4/2011
`5/2011
`
`Veasey et al
`Veasey . .... ..
`
`9/2011
`
`Veasey
`
`g, 512,297
`g, 556,864
`
`B2
`B2*
`
`g/2013
`10/2013
`
`Veasey et al.
`Veasey . .... ... ...
`
`g, 608,709
`g, 679,069
`
`B2
`B2
`
`12/2013
`3/2014
`
`Moiler et al.
`Veasey et al.
`
`A61M 5/31546
`604/207
`A61M 5/24
`604/207
`
`A61M 5/31546
`604/207
`A61M 5/24
`604/207
`
`A61M 5/31546
`604/207
`
`g, ggg, 750
`
`B2 * 11/2014
`B2 *
`9,028,454
`9,233,211 B2 *
`2001/0034507 Al
`2002/0007154 Al
`2002/005257g Al
`2002/0077852 Al
`2002/0120235 Al *
`
`5/2015
`
`1/2016
`10/2001
`1/2002
`5/2002
`6/2002
`g/2002
`
`2002/0165499 Al
`2003/0039679 Al
`2003/0050609 Al
`2003/0172924 Al
`2004/0059299 Al
`2004/012785g Al
`2004/0186431 Al
`2004/0210199 Al
`2004/0236282 Al
`2004/024934g Al
`2004/0260247 Al
`2004/0267207 Al
`2004/026720g Al
`2005/0004529 Al
`2005/0019400 Al
`2005/0033244 Al
`2005/0055011 Al
`2005/0113765 Al
`2005/0205083 Al
`2005/0209570 Al
`2005/0268915 Al
`2006/0206057 Al
`2006/0264839 Al
`2007/0093761 Al
`2007/0123829 Al
`2009/0275916 Al
`2010/0042054 Al
`2012/005352g Al
`
`11/2002
`2/2003
`3/2003
`9/2003
`3/2004
`7/2004
`9/2004
`10/2004
`11/2004
`12/2004
`12/2004
`12/2004
`12/2004
`1/2005
`1/2005
`2/2005
`3/2005
`5/2005
`9/2005
`9/2005
`12/2005
`9/2006
`11/2006
`4/2007
`5/2007
`11/2009
`2/2010
`3/2012
`
`A61M 5/24
`604/207
`A61M 5/31546
`604/211
`A61M 5/31535
`
`A61M 5/20
`604/135
`
`Veasey
`
`Veasey
`
`Veasey .. ... ... ... .
`Kirchhofer et al.
`Hansen et al.
`Moiler
`Ford et al.
`Enggaard
`
`et al.
`
`Slate et al.
`Duirs
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`Bendek et al.
`Graf et al.
`Atterbury
`Braithwaite
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`Veasey et al.
`Veasey et al.
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`Veasey et al.
`Enggaanrd
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`Veasey
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`
`FOREIGN PATENT DOCUMENTS
`
`EP
`EP
`EP
`EP
`EP
`EP
`EP
`EP
`EP
`EP
`EP
`EP
`EP
`EP
`EP
`EP
`EP
`FR
`FR
`GB
`GB
`GB
`JP
`JP
`RU
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`
`327910
`359070 Bl
`450905
`498737
`554996
`594349
`608343 Bl
`702970
`0673482
`g79610
`0937471
`0937476
`0937477 A2
`1250167 Bl
`129441g
`1570876 A2
`1855743 Bl
`2583291
`2767479
`735443
`1232899
`2141799
`05337179
`06296691
`2111019
`g907463
`9009202
`9110460
`9114467
`9307922
`9419034
`9625965 Al
`9626754
`9638190
`9736626
`9810813
`9856436
`
`g/1989
`3/1990
`10/1991
`g/1992
`g/1993
`4/1994
`g/1994
`3/1996
`4/199 g
`11/199g
`g/1999
`g/1999
`g/1999
`7/2005
`7/2005
`7/2005
`12/200 g
`12/1986
`2/1999
`g/1955
`5/1971
`1/1985
`12/1993
`10/1994
`5/199 g
`g/1989
`g/1990
`7/1991
`10/1991
`4/1993
`9/1994
`g/1996
`9/1996
`12/1996
`10/1997
`3/199 g
`12/199 g
`
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`US 9,604,008 B2
`Page 4
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`(56)
`
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`
`References Cited
`
`FOREIGN PATENT DOCUMENTS
`
`98576gg
`99164gi
`99/38554
`9938554
`0110484 Al
`0119434
`02053214 Al
`02092153 A2
`03080160 Al
`2011051366 A2
`
`12/199 g
`4/1999
`g/1999
`g/1999
`2/2001
`3/2001
`7/2002
`11/2002
`10/2003
`5/2011
`
`OTHER PUBLICATIONS
`
`Ig, 200g in U. S. Appl. No.
`
`Reissue U.S. Appl. No. 10/960, 900, "Injection Syringe",
`filed Oct.
`7, 2004,
`as-filed specification,
`abstract,
`and
`including
`drawings,
`claims, as well as the reissue declaration.
`Reissue U.S. Appl. No. 11/121,331, "Injection Syringe",
`filed Dec.
`as-filed specification,
`lg, 2006,
`abstract,
`and
`including
`drawings,
`claims, as well as the reissue declaration.
`Reissue U.S. Appl. No. 11/640, 610, "Injection Syringe",
`filed May
`3, 2005,
`as-filed specification,
`abstract,
`and
`including
`drawings,
`claims, as well as the reissue declaration.
`14, 2006 in U. S. Appl. No.
`US Office Action mailed Mar.
`10/790, 866.
`US Office Action mailed Dec.
`10/960, 600.
`US Office Action mailed Apr.
`11/121,331.
`US Office Action mailed Apr.
`11/640, 610.
`* cited by examiner
`
`17, 2009 in U. S. Appl. No.
`
`17, 2009 in U. S. Appl. No.
`
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`FIG. 12
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`US 9,604,008 B2
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`1
`DRIVE MECHANISMS SUITABLE FOR USE
`IN DRUG DELIVERY DEVICES
`
`CROSS REFERENCE TO RELATED
`APPLICATIONS
`
`application of
`The present
`is a continuation
`application
`U.S. patent application Ser. No. 12/941, 702, filed Nov. 8,
`2010, now U.S. Pat. No. 9,028,454, which is a continuation
`application of U.S. patent application Ser. No. 12/320, 189,
`filed Jan. 21, 2009, now U.S. Pat. No. 7,850,662, which is
`a continuation application of U.S. patent application Ser. No.
`11/520, 598, filed Sep. 14, 2006, now U.S. Pat. No. 7,935,
`of U.S. patent
`088, which is a continuation
`application
`application Ser. No. 10/790, 866, filed Mar. 3, 2004, aban-
`and claims priority to GB Patent Application No.
`doned,
`0304822.0, filed Mar. 3, 2003, the entire contents of each of
`herein by reference.
`which are incorporated
`
`TECHNICAL FIELD
`
`suit-
`The present
`to drive mechanisms
`relates
`invention
`able for use in drug delivery devices,
`in particular pen-type
`injectors, having dosage setting means, enabling the admin-
`istration of medicinal products
`from a multi-dose
`cartridge.
`In particular,
`to such drug
`relates
`the present
`invention
`delivery devices where a user may set the dose.
`
`BACKGROUND
`
`Such drug delivery devices have application where regu-
`injection by persons without
`formal medical
`lar
`training
`occurs, i.e., patients. This is increasingly
`common amongst
`self-treatment
`those having
`diabetes where
`enables
`such
`to conduct efl'ective management of their diabetes.
`persons
`set a number of requirements
`for
`These circumstances
`drug delivery devices of this kind. The device must be robust
`in construction, yet easy to use in terms of the manipulation
`of the parts, understanding
`by a user of its operation and the
`delivery of the required dose of medicament. Dose setting
`In the case of those with
`must be easy and unambiguous.
`diabetes, many users will be physically infirm and may also
`have impaired vision requiring the drive mechanism to have
`force and an easy to read dose setting
`low dispensing
`display. Where the device is to be disposable
`rather
`than
`the device should be cheap to manufacture
`reusable,
`and
`easy to dispose of (preferably being suitable for recycling).
`the number of parts required to
`these requirements
`To meet
`assemble the device and the number of material
`the
`types
`device is made from need to be kept
`to a minimum.
`User operated
`devices
`are well known
`delivery
`drug
`field.
`within the medical
`In U.S. Pat. No. 5,304, 152 a dispensing
`device is dis-
`length ratio of
`closed which has a body length to plunger
`about I:I in order to allow the dispensing of relatively large
`doses. Whilst
`this device provides many improvements
`over
`the easy correction of a set overdose remains
`the prior art
`unresolved without either dispensing the set amount of fluid
`or dismantling
`the cartridge.
`WO 9938554 A2 teaches an injection syringe for appor-
`tioning set doses of a medicine from a cartridge wherein a
`coupling (i.e.,
`drive mechanism comprising a unidirectional
`correction of a set
`is disclosed which allows
`a ratchet)
`the set amount of fluid or
`overdose without
`dispensing
`the dismantling of the cartridge.
`requiring
`it was
`the drive mechanism
`found
`that
`Surprisingly
`a unidirec-
`according to instant
`invention without
`having
`
`10
`
`15
`
`20
`
`25
`
`30
`
`35
`
`40
`
`45
`
`50
`
`55
`
`60
`
`65
`
`for
`tional coupling provides a valuable technical alternative
`force is needed
`reduced
`to
`drive mechanisms,
`wherein
`actuate the mechanism. This is achieved by the introduction
`of a clutch means as defined by instant
`invention. The drive
`mechanism according to instant
`further provides
`invention
`the advantage of intuitive
`and easy to use correction of a set
`dose.
`
`SUMMARY
`
`thread engaged with the
`
`located between the dose dial sleeve
`
`According to a first aspect of the present
`a drive
`invention,
`mechanism for use in a drug delivery device is provided
`comprising:
`a housing having a helical
`thread;
`a dose dial sleeve having a helical
`thread of the said housing;
`helical
`a drive sleeve releasibly connected to the said dose dial
`sleeve;
`and a clutch means
`and the drive sleeve;
`characterized
`in that,
`a) when the dose dial
`sleeve are
`sleeve and the drive
`the dose dial
`are
`sleeve
`sleeve
`and the drive
`coupled,
`to the housing;
`allowed to rotate with respect
`and
`b) when the dose dial
`sleeve and the drive sleeve are
`rotation of the dose dial sleeve with respect
`to
`de-coupled,
`rotation of the drive sleeve
`is allowed, whilst
`the housing
`to the housing
`axial
`is not allowed, whereby
`with respect
`movement of the drive sleeve is allowed so that a force is
`direction to the proximal end
`transferred in the longitudinal
`of the drug delivery device.
`of the drive mechanism of
`In a preferred
`embodiment
`com-
`the said drive mechanism further
`invention
`instant
`prises a piston rod adapted to operate through the housing
`the said force in the said longitudinal
`direction
`and transfer
`end of the drug delivery device.
`to the proximal
`In another preferred embodiment of the drive mechanism
`of instant
`the said dose dial sleeve further com-
`invention
`thread, which has the same lead as the lead
`prises a helical
`of the helical
`thread of the said drive sleeve.
`of instant
`In a more specific embodiment
`the
`invention,
`drive mechanism further comprises a nut, which is rotatable
`to the drive sleeve and axially displaceable but
`with respect
`not rotatable with respect
`to the housing.
`device" according
`The term "drug delivery
`to instant
`or re-
`or multi-dose,
`shall mean a single-dose
`invention
`a selected dose of a
`useable device designed to dispense
`selected doses, e.g.
`medicinal
`product, preferably multiple
`low molecular weight heparins,
`growth hormones,
`insulin,
`etc. Said device may
`and their analogues
`and/or derivatives
`be of any shape, e.g. compact or pen-type. Dose delivery
`may be provided through a mechanical
`(optionally manual)
`or electrical drive mechanism or stored energy drive mecha-
`nism, such as a spring, etc. Dose selection may be provided
`a manual mechanism or electronic mechanism.
`through
`said device may contain components
`designed
`Additionally,
`such as blood glucose
`to monitor physiological
`properties
`levels, etc. Furthermore,
`the said device may comprise
`a
`the term "drug
`needle or may be needle-free.
`In particular,
`delivery device" shall mean a disposable multi-dose
`pen-
`dose delivery
`type device having mechanical
`and manual
`for
`and dose
`selection mechanisms,
`is designed
`which
`formal medical
`regular use by persons without
`training such
`the drug delivery device is of the
`as patients. Preferably,
`injector-type.
`The term "housing" according to instant
`invention
`shall
`("main housing",
`any exterior housing
`preferably mean
`
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`

`US 9,604,008 B2
`
`"body", "shell") or interior housing ("insert", "inner body")
`thread. The housing may be designed to
`a helical
`having
`handling of the
`enable the safe, correct, and comfortable
`drug delivery device or any of its mechanism. Usually,
`it is
`designed to house,
`fix, protect, guide,
`engage with
`and/or
`any of the inner components
`of the drug delivery
`device
`(e.g. , the drive mechanism,
`cartridge, plunger, piston rod) by
`limiting the exposure to contaminants,
`such as liquid, dust,
`dirt etc. In general,
`the housing may be unitary or a multipart
`component of tubular or non-tubular
`the
`shape. Usually,
`serves to house a cartridge
`exterior housing
`from which a
`number of doses of a medicinal product may by dispensed.
`of instant
`In a more specific embodiment
`the
`invention,
`is provided with a plurality of maximum
`exterior housing
`dose stops adapted to be abutted by a radial stop provided on
`the dose dial sleeve. Preferably, at least one of the maximum
`dose stops comprises a radial stop located between a helical
`at a second end of the
`thread and spline means provided
`least one of the maximum dose
`at
`housing. Alternatively;
`stops comprises a part of a raised window portion provided
`at a second end of the housing.
`The term "engaged" according to instant
`invention
`shall
`particularly mean the interlocking of two or more compo-
`nents of the drive mechanism/drug
`delivery device, e.g. a
`thread; or meshed teeth connection,
`the
`preferably
`spline,
`interlocking of helical
`threads of components
`("threadedly
`engaged").
`thread" according to instant
`The term "helical
`invention
`thread, e.g., a cylindrical
`shall preferably mean a full or part
`located on the internal
`external
`rib/groove,
`and/or
`spiral
`surface of a component of the drug delivery device, having
`or
`section
`or
`an essentially
`rounded
`triangular
`square
`free rotational
`to allow continuous
`axial
`designed
`and/or
`between components. Optionally,
`a thread may
`movement
`rotational or axial movement
`be further designed to prevent
`of certain components
`in one direction.
`The term "dose dial sleeve" according to instant
`invention
`component of essentially
`shall mean an essentially
`tubular
`circular cross-section having either:
`thread, or
`a) both an internal
`and external
`thread, or
`b) an internal
`c) an external
`thread.
`the dose dial sleeve according to instant
`inven-
`Preferably,
`tion comprises
`a lead, which is
`a helical
`thread having
`the same as the lead of the helical
`similar
`to, (preferably
`thread of the drive sleeve. In yet another preferred embodi-
`the dose dial sleeve is designed to indicate a selected
`ment
`dose of a dispensable product. This may be achieved by use
`of markings,
`etc., e.g. , printed on the
`numerals,
`symbols,
`surface of the dose dial sleeve or an odometer, or
`external
`the like.
`of instant
`In a more specific embodiment
`the
`invention,
`sleeve is provided with a plurality of radially
`dose dial
`adapted to abut a corresponding
`extending members
`plural-
`ity of radial
`stops provided at a second end of the housing.
`The term "lead" according
`to instant
`invention
`shall
`preferably mean the axial distance a nut would advance in
`"lead" shall mean the
`one complete revolution;
`preferably
`having a helical
`axial distance through which a component
`i.e. dose dial sleeve, drive sleeve, piston rod, etc., of
`thread,
`the drive mechanism travels during one rotation. Therefore
`lead is a function of the pitch of the thread of the relevant
`component.
`The term "pitch" according
`to instant
`invention
`shall
`preferably mean the distance between consecutive contours
`to the axis of the
`on a helical
`thread, measured
`parallel
`helical
`thread.
`
`5
`
`10
`
`15
`
`20
`
`25
`
`30
`
`35
`
`40
`
`45
`
`50
`
`55
`
`60
`
`65
`
`The term "drive sleeve" according to instant
`invention
`shall mean any essentially tubular component of essentially
`con-
`circular cross-section and which is further
`releasibly
`nected to the dose dial sleeve. In a preferred embodiment
`the
`drive sleeve is further engaged with the piston rod.
`embodiment of instant
`In a more particular
`the
`invention,
`drive sleeve is provided at a first end with first and second
`thread between the first
`helical
`flanges with an intermediate
`and second flanges, having a nut disposed between the first
`and second flanges
`and keyed to the housing
`by spline
`stop may be provided on a
`means. Optionally,
`a first radial
`second face of the nut and a second radial
`stop may be
`provided on a first face of the second flange.
`connected"
`The term "releasibly
`according
`to instant
`of
`shall preferably mean that
`two components
`invention
`instant mechanism or device are reversibly joined to each
`e.g. by means
`other, which allows coupling and decoupling,
`of a clutch.
`The term "piston rod" according to instant
`invention shall
`adapted to operate through/within
`mean a component
`the
`to translate
`axial movement
`designed
`housing,
`through/
`within the drug delivery device, preferably
`from the drive
`for the purpose of discharging/dispens-
`sleeve to the piston,
`ing an injectable product. Said piston rod may be flexible or
`a rack and pinion
`not. It may be a simple rod, a lead-screw,
`system, a worm gear system, or the like. The "piston rod"
`having a circular or non-
`further mean a component
`shall
`It may be made of any
`cross-section.
`circular
`suitable
`material known by a person skilled in the art.
`In a preferred embodiment,
`the piston rod comprises
`at
`least one, more preferably
`two, external
`internal
`and/or
`of the
`In another
`helical
`threads.
`preferred
`embodiment
`piston rod according
`a first helical
`to instant
`invention,
`thread is located at a first end and a second helical
`thread is
`located at a second end of the said piston rod, whereby the
`said threads may have the same or, preferably,
`opposite
`the piston rod
`dispositions.
`In another preferred embodiment
`of instant
`invention comprises threads having the same leads
`at the first and the second end.
`In yet another preferred embodiment of instant
`invention
`the lead of the first helical
`thread of the piston rod shall be
`than the lead of the second helical
`thread. More
`greater
`the ratio of the leads of the helical
`threads of the
`preferred,
`is I:I, 01 to I:20,
`said first and the second helical
`threads
`I:I, I to I:10. Preferably,
`one of the
`even more preferred
`is designed to engage with the drive sleeve.
`said threads
`of the
`in another preferred
`embodiment
`Alternatively,
`piston rod of instant
`the piston rod is designed to
`invention,
`have attached, optionally by means of a journal bearing,
`a
`toothed gear, and wherein said toothed gear is designed to
`mesh with the threads of the drive sleeve and the teeth of a
`said toothed rack is fixed to the
`toothed rack, whereby
`housing.
`The term "first end" according to instant
`invention
`shall
`end of the device or
`end. The proximal
`mean the proximal
`a component of the device shall mean the end, which is
`end of the device.
`to the dispensing
`closest
`The term "second end" according to instant
`invention
`shall mean the distal end. The distal end of the device or a
`of the device
`is
`shall mean the end, which
`component
`end of the device.
`away from the dispensing
`furthest
`The term "clutch means" according to instant
`invention
`the dose
`shall mean any means, which releasibly connects
`dial sleeve and the drive sleeve and which is designed to
`allow rotation of the dose dial sleeve and the drive sleeve
`with respect to the housing when the dose dial sleeve and the
`sleeve are coupled and, when both are de-coupled,
`drive
`
`PFIZER, INC. v. SANOFI-AVENTIS DEUTSCHLAND GMBH
`
`Ex. 1005, p. 19 of 26
`
`

`

`US 9,604,008 B2
`
`a
`
`rotation of the dose dial sleeve with respect
`to the
`allows
`housing, but does not allow rotation of the drive sleeve with
`and allows axial movement of the
`to the housing
`respect
`con-
`sleeve. Preferably,
`the clutch means
`releasibly
`drive
`nects the drive sleeve to the housing. Accordingly,
`the term
`for the purpose of
`clutch means
`is any clutch engaging
`in rotation, e.g., by use
`reversibly locking two components
`of axial forces to engage a set of face teeth (saw teeth, dog
`faces.
`teeth, crown teeth) or any other suitable
`frictional
`of instant
`In a more specific embodiment
`invention,
`second end of the clutch means
`is provided with a plurality
`of dog teeth adapted to engage with a second end of the dose
`dial sleeve.
`the clutch means of instant
`In an alternative
`embodiment,
`invention is a locking spring, operable, e.g., by means of a
`dose dial button, between a first, relaxed position,
`in which
`to rotation with
`the dose dial sleeve is locked with respect
`the drive sleeve and a second, deformed position,
`in which
`to rotation with
`the dose dial sleeve is locked with respect
`the housing.
`In still another embodiment of instant
`the drive
`invention,
`a clicker means, optionally
`comprises
`mechanism further
`disposed between the clutch means and spline means pro-
`vided on the housing.
`the clicker means comprises a sleeve provided
`Optionally,
`at a first end with a helically extending arm, a free end of the
`and at a second end with a
`arm having a toothed member;
`plurality of circumferentially
`directed saw teeth adapted to
`plurality of circumferentially
`engage a corresponding
`saw
`the clicker
`teeth provided on the clutch means. Alternatively,
`means comprises a sleeve provided at a first end with at least
`one helically extending arm and at least one spring member,
`a free end of the arm having a toothed member,
`and at a
`second end with a plurality of circumferentially
`directed saw
`plurality of circum-
`teeth adapted to engage corresponding
`ferentially directed saw teeth provided on the clutch means.
`In still another embodiment of the drive mechanism of the
`the drive mechanism is provided with a first stop
`invention,
`in the form of an external
`flange on the
`means, preferably
`dose dial sleeve, adapted to engage limiting means associ-
`ated with the housing, preferably in the form of an internal
`the maximum dose which can
`to limit
`flange in the housing,
`of the drive mecha-
`be dialed.
`In yet another
`embodiment
`nism of the
`the drive mechanism is
`invention,
`further
`provided with a second stop means, preferably in the form
`of an external
`flange on the drive sleeve, adapted to engage
`in the form of a limiting
`limiting means, preferably
`nut
`keyed to the housing and mounted for rotation on an external
`threaded section of the drive sleeve,
`to provide an end of life
`stop.
`A second aspect of instant
`invention provides an assembly
`for use in a drug delivery
`device comprising
`the drive
`mechanism according to instant
`invention.
`A third aspect of the present
`a drug
`invention
`provides
`the drive mechanism or the
`device comprising
`delivery
`assembly according to instant
`invention.
`aspect of the present
`A fourth
`a
`invention
`provides
`method of assembling a drug delivery device compr