IIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIII
`US009526844B2
`
`lI2j United States Patent
`Veasey et al.
`
`(Io) Patent No. :
`(45) Date of Patent:
`
`US 9,526,844 B2
`*Dec. 27, 2016
`
`(54) PEN-TYPE INJECTOR
`
`(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, Frankfurt
`am Main (DE)
`
`( * ) Notice:
`
`the term of this
`Subject to any disclaimer,
`is extended or adjusted under 35
`patent
`U.S.C. 154(b) by 0 days.
`to a terminal
`is subject
`This patent
`claimer.
`
`dis-
`
`(21) Appl. No. : 15/156, 616
`
`(22)
`
`Filed:
`
`May 17, 2016
`
`(65)
`
`US 2016/0256633 Al
`
`Prior Publication Data
`Sep. 8, 2016
`
`Related U.S. Application Data
`(60) Continuation of application No. 14/946, 203, filed on
`Nov. 19, 2015, now Pat. No. 9,408,979, 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)
`
`(58) Field of Classification Search
`CPC ..................... A61M 5/31551; A61M 5/31533;
`A61M 5/31535; A61M 5/31536; A61M
`5/31541; A61M 5/31546; A61M
`5/31585; A61M 2005/2407; A61M
`2205/581; A61M 2205/582
`(Continued)
`
`(56)
`
`References Cited
`
`U.S. PATENT DOCUMENTS
`
`533,575 A
`2,717,597 A
`
`2/1895 Wilkens
`9/1955 Hein, Jr.
`(Continued)
`
`FOREIGN PATENT DOCUMENTS
`
`DE
`EP
`
`3609555
`0673482
`
`9/1987
`4/1998
`(Continued)
`
`OTHER PUBLICATIONS
`
`Reissue U.S. Appl. No. 10/442, 855, "Injection Syringe",
`21, 2003.
`
`filed May
`
`(Continued)
`
`Pri mary Examiner
`Manuel Mendez
`(74) Attorney, Agent, or Firm
`McDonnell Boehnen
`Hulbert & Berghofi' LLP
`
`ABSTRACT
`(57)
`The present
`invention relates to injectors,
`such as pen-type
`that provide for administration of medicinal prod-
`injectors,
`and permit a user to set the
`ucts from a multidose-cartridge
`delivery dose. The injector may include a housing,
`a piston
`a dose dial
`rod adapted
`to operate through
`the housing,
`sleeve located between the housing and the piston rod, and
`a drive sleeve located between the dose dial sleeve and the
`thread of
`piston rod. The dose dial sleeve may have a helical
`first lead and the drive sleeve may have a helical groove of
`lead of the helical
`second lead. The first
`thread and the
`second lead of the helical groove may be the same.
`
`30 Claims, 7 Drawing Sheets
`
`75
`
`62
`64
`7644~
`60
`70
`4
`20
`50
`
`34
`36
`32
`18
`22
`
`39
`38
`
`37
`
`20
`
`24
`
`30
`108
`19
`40
`
`16
`
`10
`
`PFIZER, INC. v. SANOFI-AVENTIS DEUTSCHLAND GMBH
`
`Ex. 1004, p. 1 of 15
`
`

`

`et al.
`
`Bacon
`Bitdinger et al.
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`
`US 9,526,844 B2
`Page 2
`
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`4/2003
`4/2003
`5/2003
`5/2003
`6/2003
`8/2003
`9/2003
`12/2003
`2/2004
`
`AAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAB
`
`l
`Bl
`Bl
`Bl
`Bl
`Bl
`Bl
`Bl
`Bl
`Bl
`Bl
`Bl
`Bl
`Bl
`Bl
`Bl
`Bl
`Bl
`Bl
`B2
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`B2
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`B2
`
`5,447, 150
`5,478,316
`5,480,387
`5,492,534
`5,505,704
`5,546,932
`5,547, 131
`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
`5,681,285
`5,688,251
`5,709,662
`5,716,990
`5,728,075
`5,743,889
`5,755,692
`5,823,998
`5,843,036
`5,882,718
`5,898,028
`5,921,966
`5,928,201
`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
`6,059,755
`6,074,372
`6,083, 197
`6, 110,149
`6, 129,080
`6, 146,361
`6, 193,698
`6,221,046
`6,221,053
`6,231,540
`6,235,004
`6,248,090
`6,248,095
`6,258,062
`6,269,340
`6,277,097
`6,277,098
`6,277,099
`6,277, 101
`6,281,225
`6,283,941
`6,287,283
`6,302,869
`6,312,413
`6,340,357
`6,383,167
`6,514,230
`6,547,763
`6,547,764
`6,562,011
`6,569, 126
`6,582,404
`6,605,067
`6,613,019
`6,663,602
`6,692,472
`
`Related U.S. Application Data
`continuation of application No. 14/635, 573, filed on
`Mar. 2, 2015, now Pat. No. 9,233,211, which is a
`continuation of application No. 13/919,251, filed on
`Jun. 17, 2013, now Pat. No. 9,011,391, which is a
`division of application No. 13/040, 198, filed on Mar.
`3, 2011, now Pat. No. 8,512,297, which is a contin-
`uation of application No. 11/483, 546, filed on Jul. 11,
`2006, now Pat. No. 7,918,833, which is a continu-
`ation of application No. 10/790, 225, filed on Mar. 2,
`2004, now abandoned.
`
`(51)
`
`(2006.01)
`(2006.01)
`
`Int. Cl.
`261M 5/32
`361M 5/31
`(52) U.S. CI.
`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
`USPC ...... 604/208 —211, 68; 128/DIG. 12, DIG. 13
`See application file for complete search history.
`
`(56)
`
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`PFIZER, INC. v. SANOFI-AVENTIS DEUTSCHLAND GMBH
`
`Ex. 1004, p. 2 of 15
`
`

`

`US 9,526,844 B2
`Page 3
`
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`
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`
`PFIZER, INC. v. SANOFI-AVENTIS DEUTSCHLAND GMBH
`
`Ex. 1004, p. 3 of 15
`
`

`

`U.S. Patent
`
`Dec. 27, 2016
`
`Sheet 1 of 7
`
`US 9,526,844 B2
`
`78
`
`20
`
`108
`19
`40
`
`10
`
`PFIZER, INC. v. SANOFI-AVENTIS DEUTSCHLAND GMBH
`
`Ex. 1004, p. 4 of 15
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`

`

`U.S. Patent
`
`Dec. 27, 2016
`
`Sheet 2 of 7
`
`US 9,526,844 B2
`
`70
`
`30
`
`20
`
`70
`
`30
`
`20
`
`10
`
`PFIZER, INC. v. SANOFI-AVENTIS DEUTSCHLAND GMBH
`
`Ex. 1004, p. 5 of 15
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`

`

`U.S. Patent
`
`Dec. 27, 2016
`
`Sheet 3 of 7
`
`US 9,526,844 B2
`
`50
`
`40
`30
`
`10
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`PFIZER, INC. v. SANOFI-AVENTIS DEUTSCHLAND GMBH
`
`Ex. 1004, p. 6 of 15
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`

`

`U.S. Patent
`
`Dec. 27, 2016
`
`Sheet 4 of 7
`
`US 9,526,844 B2
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`PFIZER, INC. v. SANOFI-AVENTIS DEUTSCHLAND GMBH
`
`Ex. 1004, p. 7 of 15
`
`

`

`U.S. Patent
`
`Dec. 27, 2016
`
`Sheet 5 of 7
`
`US 9,526,844 B2
`
`A(82)
`
`G(40)
`36
`
`F(50) 20
`
`C(70)
`
`B(76)
`
`D(30)
`
`FIIG. 9
`
`F(50)
`
`G(40)
`
`E(60)
`D(30) B(76)
`C(70)
`FIIG. 30
`
`A(82)
`
`PFIZER, INC. v. SANOFI-AVENTIS DEUTSCHLAND GMBH
`
`Ex. 1004, p. 8 of 15
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`

`

`U.S. Patent
`
`Dec. 27, 2016
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`Sheet 6 of 7
`
`US 9,526,844 B2
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`104
`
`&08
`
`FIIG. 32
`
`106
`
`FIIG. 13
`
`70
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`PFIZER, INC. v. SANOFI-AVENTIS DEUTSCHLAND GMBH
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`Ex. 1004, p. 9 of 15
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`

`

`U.S. Patent
`
`Dec. 27, 2016
`
`Sheet 7 of 7
`
`US 9,526,844 B2
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`'t 00
`
`PFIZER, INC. v. SANOFI-AVENTIS DEUTSCHLAND GMBH
`
`Ex. 1004, p. 10 of 15
`
`

`

`US 9,526,844 B2
`
`1
`PEN-TYPE INJECTOR
`
`CROSS REFERENCE TO RELATED
`APPLICATIONS
`
`is a continuation of U.S. patent
`The present application
`application Ser. No. 14/946, 203, filed Nov. 19, 2015, now
`of U.S.
`U.S. Pat. No. 9,408,979, which is a continuation
`patent application Ser. No. 14/635, 573, filed Mar. 2, 2015,
`now U.S. Pat. No. 9,233,211, which is a continuation of U.S.
`patent application Ser. No. 13/919,251, filed Jun. 17, 2013,
`now U.S. Pat. No. 9,011,391, which is a divisional of U.S.
`patent application Ser. No. 13/040, 198, filed Mar. 3, 2011,
`now U.S. Pat. No. 8,512,297, which is a continuation of U.S.
`patent application Ser. No. 11/483, 546, filed Jul. 11, 2006,
`now U.S. Pat. No. 7,918,833, which is a continuation of U.S.
`patent application Ser. No. 10/790, 225, filed Mar. 2, 2004,
`which claims priority to GB 0304822.0 filed Mar. 3, 2003,
`contents of which are incorporated
`herein by
`the entire
`reference.
`
`BACKGROUND
`
`invention relates to pen-type injectors,
`The present
`that is,
`to injectors of the kind that provide
`for administration
`by
`injection of medicinal products
`cartridge.
`from a multidose
`In particular,
`invention relates to such injectors
`the present
`where a user may set the dose.
`Such inj ectors have application where regular
`injection by
`occurs. This
`is
`formal medical
`persons without
`training
`common amongst
`those having diabetes where
`increasingly
`self-treatment
`effective
`to conduct
`such persons
`enables
`of their diabetes.
`management
`set a number of requirements
`for
`These circumstances
`injectors of this kind. The injector must be robust
`pen-type
`in construction, yet easy to use both in terms of the manipu-
`by a user of its
`lation of the parts
`and understanding
`In the case of those with diabetes, many users will
`operation.
`be physically
`infirm and may also have impaired vision.
`Where the injector is to be disposable
`than reusable,
`rather
`should be cheap to manufacture
`and easy to
`the injector
`dispose of (preferably being suitable
`for recycling).
`
`SUMMARY
`
`invention
`
`that
`
`an
`
`of the present
`It
`is an advantage
`injector is provided.
`improved pen-type
`According to a first aspect of the present
`injector comprises
`pen-type
`a housing;
`a piston rod adapted to operate through housing;
`a dose dial sleeve located between the housing
`and the
`piston rod, the dose dial sleeve having a helical thread of first
`lead;
`a drive sleeve located between the dose dial sleeve and the
`a helical groove of
`sleeve having
`the drive
`piston rod,
`second lead;
`characterized in that the first lead of the helical
`thread and
`the second lead of the helical groove are the same.
`the piston rod has a first threaded portion at a
`Preferably,
`first end and a second threaded portion at a second end;
`an insert or radially inwardly
`extending flange is located
`in the housing and through which the first threaded portion
`of the piston rod may rotate;
`the dose dial sleeve being rotatable with respect
`housing and the insert;
`
`invention,
`
`a
`
`to the
`
`connected to the dose
`the drive sleeve being releasably
`dial sleeve and connected to the piston rod for rotation with
`portion of the
`thereto along the second threaded
`respect
`piston rod;
`a button is located on the dose dial sleeve and rotatable
`to the does dial sleeve; and
`with respect
`clutch means are provided which upon depression of the
`rotation between the dose dial sleeve and the
`button permit
`drive sleeve.
`the injector further comprises
`a nut which is
`Preferably,
`to the drive sleeve and axially dis-
`rotatable with respect
`placeable but not rotatable with respect
`to the housing.
`More preferably,
`the drive sleeve is provided at a first end
`with first and second flanges with an intermediate
`thread
`between the first and second flanges,
`the nut being disposed
`and keyed to the
`the first and second flanges
`between
`by spline means. Additionally,
`a first
`radial
`housing
`stop
`may be provided on a second face of the nut and a second
`stop may be provided on a first face of the second
`radial
`flange.
`the first thread of the piston rod is oppositely
`Preferably,
`disposed to the second thread of the piston rod.
`a second end of the clutch is provided with a
`Preferably,
`plurality of dog teeth adapted to engage with a second end
`of the dose dial sleeve.
`includes clicker
`injector
`the pen-type
`further
`Preferably,
`means disposed between the clutch means and spline means
`provided on the housing.
`the clicker means
`More preferably,
`comprises
`a sleeve
`provided at a first end with a helically extending arm, a free
`end of the arm having a toothed member, and at a second end
`of circumferentially
`directed
`saw teeth
`with a plurality
`plurality of circumfer-
`adapted to engage a corresponding
`entially saw teeth provided on the clutch means.
`the clicker means comprises
`a sleeve pro-
`Alternatively,
`vided at a first end with at least one helically extending arm
`and at least one spring member, a free end of the arm having
`and at a second end with a plurality of
`a toothed member,
`directed saw teeth adapted to engage
`a
`circumferentially
`of circumferentially
`directed saw
`corresponding
`plurality
`teeth provided on the clutch means.
`the main housing is provided with a plurality
`Preferably,
`of maximum dose stops adapted to be abutted by a radial
`stop provided on the dose dial sleeve. More preferably,
`at
`least one of the maximum dose stops comprises a radial stop
`located between a helical
`rib and spline means provided at
`a second end of the housing. Alternatively,
`at least one of the
`a part of a raised window
`maximum dose stops comprises
`portion provided at a second end of the housing.
`the dose dial sleeve is provided with a plural-
`Preferably,
`ity of radially extending members
`adapted to abut a corre-
`sponding plurality of radial
`stops provided at a second end
`of the housing.
`
`BRIEF DESCRIPTION OF THE FIGURES
`
`The invention will now be described with reference to the
`in which:
`accompanying
`drawings
`FIG. 1 shows a sectional view of a pen-type
`injector
`in
`accordance with the present
`in a first, cartridge
`invention
`full, position;
`FIG. 2 shows a sectional view of the pen-type injector of
`FIG. 1 in a second, maximum first dose dialed, position;
`FIG. 3 shows a sectional view of the pen-type injector of
`FIG. 1 in a third,
`first maximum first dose dispensed,
`position;
`
`5
`
`10
`
`15
`
`20
`
`25
`
`30
`
`35
`
`40
`
`45
`
`50
`
`55
`
`60
`
`65
`
`PFIZER, INC. v. SANOFI-AVENTIS DEUTSCHLAND GMBH
`
`Ex. 1004, p. 11 of 15
`
`

`

`US 9,526,844 B2
`
`of parts of the
`dialing up of a
`
`FIG. 4 shows a sectional view of the pen-type injector of
`FIG. 1 in a fourth,
`final dose dialed, position;
`FIG. 5 shows a sectional view of the pen-type injector of
`FIG. 1 in a fifth,
`final dose dispensed, position;
`view of a first detail of the
`FIG. 6 shows
`a cut-away
`injector of FIG. 1;
`pen-type
`FIG. 7 shows a partially cut-away view of a second detail
`of the pen-type
`injector of FIG. 1;
`FIG. S shows a partially cut-away view of a third detail of
`injector of FIG. 1;
`the pen-type
`FIG. 9 shows
`the relative movement
`shown in FIG. 1 during
`injector
`pen-type
`dosej
`of parts of the
`FIG. 10 shows
`the relative movement
`injector shown in FIG. 1 during dialing down of a
`pen-type
`dosej
`FIG. 11 shows
`injector
`pen-type
`dosej
`FIG. 12 shows a partially cut-away view of the pen-type
`injector of FIG. 1 in the second, maximum first dose dialed,
`position;
`FIG. 13 shows a partially cut-away view of the pen-type
`injector of FIG. 1 in the fourth,
`final dose dialed, position;
`FIG. 14 shows a partially cut-away view of the pen-type
`injector of FIG. 1 in one of the first,
`third or fifth positions;
`FIG. 15 shows a cut-away view of a first part of a main
`housing of the pen-type
`injector of FIG. 1; and
`FIG. 16 shows a cut-away view of a second part of the
`injector of FIG. 1.
`main housing of the pen-type
`
`the relative movement of parts of the
`shown in FIG. 1 during dispensing of a
`
`DETAILED DESCRIPTION
`
`to FIGS. 1 to 5,
`there may be seen a
`Referring
`first
`pen-type injector in accordance with the present
`invention in
`a number of positions.
`The pen-type
`injector comprises
`a housing having a first
`cartridge retaining part 2, and second main housing part 4.
`A first end of the cartridge retaining means 2 and a second
`end of the main housing 4 are secured together by retaining
`features 6. In the illustrated
`the cartridge
`embodiment,
`retaining means 2 is secured within the second end of the
`main housing 4.
`A cartridge S from which a number of doses of medicinal
`product may be dispensed
`is provided
`in the cartridge
`retaining part 2. A piston 10 is retained in a first end of the
`cartridge S.
`cap 12 is releasably retained over a second
`A removable
`end of the cartridge retaining
`part 2. In use the removable
`cap 12 can be replaced by a user with a suitable needle unit
`cap 14 is used to cover
`shown). A replaceable
`the
`(not
`cartridge retaining part 2 extending from the main housing
`the outer dimensions of the replaceable cap 14
`4. Preferably,
`to the outer dimensions of the main
`are similar or identical
`housing 4 to provide the impression of a unitary whole when
`cap 14 is in position covering the cartridge
`the replaceable
`part 2.
`retaining
`an insert 16 is provided at
`In the illustrated embodiment,
`a first end of the main housing 4. The insert 16 is secured
`rotational or longitudinal motion. The insert 16 is
`against
`circular opening 1S extending
`provided with a threaded
`the insert may be formed inte-
`therethrough. Alternatively,
`4 the form of a radially
`grally with the main housing
`directed flange having an internal
`thread.
`inwardly
`from a first end of a piston rod
`A first thread 19 extends
`20. The piston rod 20 is of generally
`section. The
`circular
`first end of the piston rod 20 extends
`through the threaded
`
`opening 1S in the insert 16.A pressure foot 22 is located at
`the first end of the piston rod 20. The pressure
`foot 22 is
`disposed to abut a second end of the cartridge piston 10. A
`second thread 24 extends from a second end of the piston rod
`20. In the illustrated
`24
`the second thread
`embodiment
`a series of part
`comprises
`than a complete
`rather
`threads
`is easier to manufacture
`thread. The illustrated embodiment
`force required
`for a user
`reduce the overall
`to
`and helps
`to be dispensed.
`cause medicinal product
`The first thread 19 and the second thread 24 are oppositely
`disposed. The second end of the piston rod 20 is provided
`with a receiving recess 26.
`A drive sleeve 30 extends about
`the piston rod 20. The
`drive sleeve 30 is generally cylindrical. The drive sleeve 30
`is provided at a first end with a first radially extending flange
`32. A second radially extending flange 34 is provided spaced
`a distance along the drive sleeve 30 from the first flange 32.
`thread 36 is provided on an outer part of the
`An intermediate
`drive sleeve 30 extending between the first flange 32 and the
`second flange 34. A helical groove 3S extends
`along the
`surface of the drive sleeve 30. The second thread 24
`internal
`of the piston rod 20 is adapted to work within the helical
`groove 3S.
`A first end of the first flange 32 is adapted to conform to
`a second side of the insert 16.
`A nut 40 is located between the drive sleeve 30 and the
`main housing 2, disposed between the first flange 32 and the
`second flange 34. In the illustrated
`the nut 40
`embodiment
`is a half-nut. This assists in the assembly of the injector. The
`nut 40 has an internal
`thread matching
`the intermediate
`thread 36. The outer surface of the nut 40 and an internal
`surface of the main housing 4 are keyed together by splines
`42 (see FIGS. 10, 11, 15 and 16) to prevent
`relative rotation
`between the nut 40 and the main housing 4, while allowing
`therebetween.
`relative longitudinal movement
`A shoulder 37 is formed between a second end of the drive
`sleeve 30 and an extension 3S provided at the second end of
`the drive sleeve 30. The extension 3S has reduced inner and
`in comparison to the remainder of the drive
`outer diameters
`sleeve 30.A second end of the extension 3S is provided with
`directed flange 39.
`a radially outwardly
`A clicker 50 and a clutch 60 are disposed about
`the drive
`sleeve 30, between the drive sleeve 30 and a dose dial sleeve
`70 (to be described below).
`the second flange 34 of
`The clicker 50 is located adjacent
`the drive sleeve 30. The clicker 50 is generally
`cylindrical
`at a first end with a flexible helically
`and is provided
`extending arm 52 (shown most clearly in FIG. 6).A free end
`of the arm 52 is provided with a radially directed toothed
`member 54. A second end of the clicker 50 is provided with
`a series of circumferentially
`directed saw teeth 56 (of FIG.
`7). Each saw tooth comprises
`directed
`a longitudinally
`surface and an inclined surface.
`the clicker
`In an alternative
`embodiment
`shown)
`(not
`at least one spring member. The at
`includes
`means
`further
`least one spring member assists in the resetting of the clutch
`means 60 following dispense.
`the second end of
`The clutch means 60 is located adjacent
`sleeve 30. The clutch means
`60 is generally
`the drive
`at a first end with a series of
`cylindrical
`and is provided
`directed saw teeth 66 (see FIG. 7). Each
`circumferentially
`saw tooth comprises a longitudinally
`directed surface and an
`the second end 64 of the clutch
`inclined surface. Towards
`means 60 there is located a radially inwardly directed flange
`62. The flange 62 of the clutch means 60 is disposed between
`the shoulder 37 of the drive
`sleeve 30 and the radially
`outwardly directed flange 39 of the extension 3S.The second
`
`5
`
`10
`
`15
`
`20
`
`25
`
`30
`
`35
`
`40
`
`45
`
`50
`
`55
`
`60
`
`65
`
`PFIZER, INC. v. SANOFI-AVENTIS DEUTSCHLAND GMBH
`
`Ex. 1004, p. 12 of 15
`
`

`

`US 9,526,844 B2
`
`end of the clutch means 60 is provided with a plurality of
`dog teeth 65 (FIG. S). The clutch 60 is keyed to the drive
`sleeve 30 by way of splines
`to prevent
`relative
`(not shown)
`rotation between the clutch 60 and the drive sleeve 30.
`the clicker 50 and the
`In the illustrated
`embodiment,
`half the length of the
`clutch 60 each extend approximately
`drive sleeve 30. However,
`it will be understood
`that other
`regarding the relative lengths of these parts are
`arrangements
`possible.
`The clicker 50 and the clutch means 60 are normally
`is as shown in FIG. 7.
`that
`engaged,
`A dose dial sleeve 70 is provided outside of the clicker 50
`and clutch means 60 and radially inward of the main housing
`4. A helical groove 74 is provided about an outer surface of
`the dose dial sleeve 70.
`The main housing 4 is provided with a window 44 through
`which a part of the outer surface of the dose dial sleeve may
`be seen. The main housing
`4 is further provided with a
`rib 46, adapted to be seated in the helical groove 74
`helical
`on the outer surface of the dose dial sleeve 70. The helical
`for a single sweep of the inner surface of the
`rib 46 extends
`main housing 4. A first stop 100 is provided between the
`rib 46 (FIG. 15). A second stop
`splines 42 and the helical
`102, disposed at an angle of 180' to the first stop 100 is
`the window 44 in the main
`formed by a frame surrounding
`housing 4 (FIG. 16).
`indication of the dose that may be
`a visual
`Conveniently,
`for example
`reference
`is
`dialed,
`shown).
`numerals
`(not
`provided on the outer surface of the dose dial sleeve 70. The
`Window 44 conveniently
`only allows to be viewed a visual
`indication of the dose currently
`dialed.
`A second end of the dose dial sleeve 70 is provided with
`an inwardly directed flange in the form of number of radially
`extending members 75.A dose dial grip 76 is disposed about
`an outer surface of the second end of the dose dial sleeve 70.
`An outer diameter of the dose dial grip 76 preferably
`to the outer diameter of the main housing 4. The
`corresponds
`dose dial grip 76 is secured to the dose dial sleeve 70 to
`therebetween. The dose dial grip
`relative movement
`prevent
`76 is provided with a central opening 7S. An annular
`recess
`SO located in the second end of the dose dial grip 76 extends
`around the opening 7S.
`'T' section is provided
`A button S2 of generally
`at a
`second end of the pen-type injector. A stem S4 of the button
`S2 may extend through the opening 7S in the dose dial grip
`the inner diameter of the extension 3S of the
`76, through
`drive sleeve 30 and into the receiving recess 26 of the piston
`rod 20. The stem S4 is retained for limited axial movement
`sleeve 30 and against
`rotation with respect
`in the drive
`thereto. A head S5 of the button S2 is generally
`circular. A
`from a periphery of the head S5. The skirt
`skirt S6 depends
`recess SO of the dose
`S6 is adapted to be seated in the annular
`dial grip 76.
`Operation of the pen-type injector in accordance with the
`In FIGS. 9, 10 and
`invention will now be described.
`present
`11 arrows A, B, C, D, E, F and G represent
`the respective
`movements of the button S2, the dose dial grip 76, the dose
`dial sleeve 70, the drive sleeve 30, the clutch means 60, the
`clicker 50 and the nut 40.
`To dial a dose (FIG. 9) a user rotates the dose dial grip 76
`(arrow A). With the clicker 50 and clutch means 60 engaged,
`the drive sleeve 30, the clicker 50, the clutch means 60 and
`the dose dial sleeve 70 rotate with the dose dial grip 76.
`and tactile feedback of the dose being dialed is
`Audible
`provided by the clicker 50 and the clutch means 60. Torque
`the saw teeth 56, 66 between
`the
`is transmitted
`through
`clicker 50 and the clutch means 60. The flexible arm 52
`
`5
`
`10
`
`15
`
`20
`
`25
`
`30
`
`35
`
`40
`
`45
`
`50
`
`55
`
`60
`
`65
`
`deforms and drags the toothed member 54 over the splines
`42 to produce a click. Preferably,
`the splines 42 are dispose
`such that each click corresponds
`to a unit dose.
`The helical groove 74 on the dose dial sleeve 70 and the
`helical groove 3S in the drive sleeve 30 have the same lead.
`This allows the dose dial sleeve 70 (arrow C) to extend from
`the main housing 4 and the drive sleeve 30 (arrow D) to
`the limit of
`climb the piston rod 20 at
`the same rate. At
`stop 104 on the dose dial sleeve 70 engages
`travel, a radial
`either the first stop 100 or the second stop 102 provided on
`further movement. Rotation of
`the main housing 4 to prevent
`the piston rod 20 is prevented due to the opposing directions
`of the overhauled
`and driven threads on the piston rod 20.
`The nut 40, keyed to the main housing 4, is advanced
`thread 36 by the rotation of the drive
`along the intermediate
`sleeve 30 (arrow D). When the final dose dispensed position
`stop 106 formed on
`(FIGS. 4, 5 and 13) is reached, a radial
`a second surface of the nut 40 abuts a radial
`stop 10S on a
`first surface of the second flange 34 of the drive sleeve 30
`both the nut 40 and the drive sleeve 30 from
`preventing
`rotating further.
`In an alternative
`(not shown) a first surface
`embodiment
`of the nut 40 is provided with a radial stop for abutment with
`a radial stop provided on a second surface of the first flange
`location of the nut 40 at
`32. This aids
`the cartridge
`full
`position during assembly of the pen-type
`injector.
`dial beyond the desired dos-
`Should a user inadvertently
`the dosage to be dialed
`injector allows
`the pen-type
`age,
`down without dispense of medicinal product
`from the car-
`tridge (FIG. 10). The dose dial grip 76 is counter
`rotated.
`This causes the system to act in reverse. The flexible arm 52
`the clicker from rotating.
`now acts as a ratchet preventing
`through the clutch means 60 causes
`The torque transmitted
`the saw teeth 56,66 to ride over one another
`to create the
`clicks corresponding
`to dialed dose reduction. Preferably the
`saw teeth 56,66 are so disposed that
`the circumferential
`extent of each saw tooth corresponds
`to a unit dose.
`When the desired dose has been dialed,
`the user may then
`the button S2 (FIG. 11).
`this dose by depressing
`dispense
`This displaces the clutch means 60 axially with respect to the
`dose dial sleeve 70 causing the dog teeth 65 to disengage.
`the clutch means 60 remains keyed in rotation to
`However
`the drive sleeve 30. The dose dial sleeve 70 and associated
`dose dial grip 76 are now free to rotate (guided by the helical
`rib 46 located in helical groove 74).
`the flexible arm 52 of the
`The axial movement
`deforms
`clicker 50 to ensure
`the saw teeth 56,66 cannot be over-
`the drive sleeve 30
`hauled during dispense. This prevents
`to the main housing 4 though it is
`from rotating with respect
`thereto. This defor-
`still free to move axially with respect
`used to urge the clicker 50, and the
`mation is subsequently
`sleeve 30 to restore the
`clutch 60, back along the drive
`connection between the clutch 60 and the dose dial sleeve 70
`is removed from the button S2.
`when pressure
`axial movement of the drive sleeve 30
`The longitudinal
`causes the piston rod 20 to rotate though the opening 1S in
`the piston 10 in the
`the insert 16, thereby
`to advance
`cartridge S. Once the dialed dose has been dispensed,
`the
`dose dial sleeve 70 is prevented
`rotation by
`from further
`contact of a plurality of members 110 (FIG. 14) extending
`plurality of
`from the dose dial grip 76 with a corresponding
`stops 112 formed in the main housing 4 (FIGS. 15 and 16).
`110 extend
`In the illustrated
`the members
`embodiment,
`axially from the dose