IIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIII
`US008992486B2
`
`lI2~ United States Patent
`Veasey et al.
`
`(Io) Patent No. :
`(45) Date of Patent:
`
`US 8,992,486 B2
`Mar. 31, 2015
`
`(54) PEN-TYPE INJECTOR
`
`(71) Applicants: Robert Frederick Veasey, Warwickshire
`(GB); Robert Perkins, Oxfordshire
`(GB); David Aubrey Plumptre,
`(GB)
`Worcestershire
`
`(72)
`
`Inventors: Robert Frederick Veasey, Warwickshire
`(GB); Robert Perkins, Oxfordshire
`(GB); David Aubrey Plumptre,
`(GB)
`Worcestershire
`
`(73) Assignee:
`
`Sanofi-Aventis Deutschland GmbH,
`am Main (DE)
`Frankfurt
`
`( * ) Notice:
`
`the term of this
`Subject to any disclaimer,
`is extended or adjusted under 35
`patent
`U.S.C. 154(b) by 95 days.
`
`(21) Appl. No. : 13/909, 681
`
`(22)
`
`Filed:
`
`Jun. 4, 2013
`
`(65)
`
`Prior Publication Data
`
`US 2013/0267906 Al
`
`Oct. 10, 2013
`
`Related U.S.Application Data
`(63) Continuation of application No. 12/944, 544, filed on
`Nov. 11, 2010, now Pat. No. 8,679,069, which is a
`continuation of application No. 11/483, 546, filed on
`Jul. 11, 2006, now Pat. No. 7,918,833, which is a
`continuation of application No. 10/790, 225, filed on
`Mar. 2, 2004, now abandoned.
`
`(30)
`
`Foreign Application Priority Data
`
`Mar. 3, 2003
`
`(GB)
`
`0304822.0
`
`(51)
`
`Int. Cl.
`A 61/If 5/00
`A 61/If 5/315
`A6/M 5/24
`
`(2006.01)
`(2006.01)
`(2006.01)
`
`(52) U.S. Cl
`CPC ............. A61/If 5/31533 (2013.01);A6/M 5/24
`(2013.01);A61/If 5/31535 (2013.01);
`(Continued)
`(58) Field of ClassiTication Search
`CPC ..................... A61M5/31533; A61M 5/31536;
`A61M 5/31535; A61M 5/31551; A61M
`5/31541; A61M 5/31585
`USPC .......... 604/187, 207—211, 218, 221, 224, 232
`See application file for complete search history.
`
`(56)
`
`References Cited
`
`U.S. PATENT DOCUMENTS
`
`5,304, 152 A
`5,320,609 A
`
`4/1994 Sams
`6/1994 Haber et al.
`
`(Continued)
`
`FOREIGN PATENT DOCUMENTS
`
`EP
`EP
`
`0937471 A2
`0937476 A2
`(Continued)
`
`8/1999
`8/1999
`
`Primary Examiner
`(74) Attorney,
`Agent,
`Hulbert & Berghoff LLP
`
`Manuel Mendez
`or Firm
`
`McDonnell
`
`Boehnen
`
`ABSTRACT
`(57)
`A housing for a dispensing
`apparatus. The housing compris-
`ing a main housing and a dose dial sleeve. The dose dial sleeve
`comprising a helical groove configured to engage a threading
`provided by the housing. A dose knob is disposed near a
`end of the dose dial
`sleeve and a piston rod is
`proximal
`provided within the housing. The piston rod is non-rotatable
`a dose setting step. A driver comprises
`an internal
`during
`threading near a distal portion of the driver and is adapted to
`thread of the piston rod. A tubular clutch is
`engage an external
`located adjacent a distal end of the dose knob and operatively
`coupled to the dose knob. The dose dial sleeve may extend
`least a portion of the tubular
`around at
`circumferentially
`clutch.
`
`57 Claims, 7 Drawing Sheets
`
`75
`
`62
`64
`76
`
`50
`70
`4
`20
`50
`
`34
`36
`32
`18
`22
`
`39
`38
`48
`24
`
`37
`
`30
`108
`19
`40
`
`15
`
`10
`
`PFIZER, INC. v. SANOFI-AVENTIS DEUTSCHLAND GMBH
`
`Ex. 1003, p. 1 of 14
`
`

`

`US 8,992,486 B2
`Page 2
`
`(52) U.S. CI.
`CPC ...... 261M5/31541 (2013.01);261M5/31551
`(2013.01);36/M 5/3/56 (2013.01);36/M
`5/3/575 (2013.01);261M 5/31585 (2013.01);
`36/M 2005/2407 (2013.01);36/M 2205/58/
`(2013.01);36/M 2205/582 (2013.01);261M
`5/31536 (2013.01)
`. 604/209
`
`(56)
`
`References Cited
`
`U.S. PATENT DOCUMENTS
`
`5,480,387 A
`5,505,704 A
`5,626,566 A
`5,674,204 A
`
`1/1996 Gabriel et al.
`4/1996 Pawelka et al.
`5/1997 Petersen et al.
`10/1997 Chanoch
`
`5,6gg, 251 A
`6,083, 197 A
`6, 193,69g Bl
`6,221,046 Bl
`6,248,095 Bl
`6,899,69g B2
`7,241,27g B2
`g, 679,069 B2 *
`2002/005257g Al
`2004/0059299 Al
`
`11/1997
`7/2000
`2/2001
`4/2001
`6/2001
`5/2005
`7/2007
`3/2014
`5/2002
`3/2004
`
`Chanoch
`Umbaugh
`Kirchhofer et al.
`et al.
`Burroughs
`et al.
`Giambattista
`Sams
`Moiler
`Veasey et al.
`Moiler
`Moiler et al.
`
`FOREIGN PATENT DOCUMENTS
`
`91/14467 Al
`WO
`99/38554 Al
`WO
`9938554 Al
`WO
`* cited by examiner
`
`10/1991
`g/1999
`g/1999
`
`. .. 604/209
`
`PFIZER, INC. v. SANOFI-AVENTIS DEUTSCHLAND GMBH
`
`Ex. 1003, p. 2 of 14
`
`

`

`U.S. Patent
`
`Mar. 31, 2015
`
`Sheet 1 of 7
`
`US 8,992,486 B2
`
`20
`
`30
`108
`19
`40
`
`10
`
`PFIZER, INC. v. SANOFI-AVENTIS DEUTSCHLAND GMBH
`
`Ex. 1003, p. 3 of 14
`
`

`

`U.S. Patent
`
`Mar. 31, 2015
`
`Sheet 2 of 7
`
`US 8,992,486 B2
`
`70
`
`20
`
`70
`
`20
`
`10
`
`PFIZER, INC. v. SANOFI-AVENTIS DEUTSCHLAND GMBH
`
`Ex. 1003, p. 4 of 14
`
`

`

`U.S. Patent
`
`Mar. 31, 2015
`
`Sheet 3 of 7
`
`US 8,992,486 B2
`
`50
`
`40
`30
`
`10
`
`PFIZER, INC. v. SANOFI-AVENTIS DEUTSCHLAND GMBH
`
`Ex. 1003, p. 5 of 14
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`

`

`U.S. Patent
`
`Mar. 31, 2015
`
`Sheet 4 of 7
`
`US 8,992,486 B2
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`PFIZER, INC. v. SANOFI-AVENTIS DEUTSCHLAND GMBH
`
`Ex. 1003, p. 6 of 14
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`

`

`U.S. Patent
`
`Mar. 31, 2015
`
`Sheet 5 of 7
`
`US 8,992,486 B2
`
`A(82)
`
`G(40)
`36
`
`F(50) 20
`
`(
`
`)
`D(30)
`
`C(70)
`
`~(76)
`
`FIIG. 9
`
`F(50)
`
`G(40)
`
`E(60)
`D(30) B(76)
`C(70)
`FIIG. 10
`
`A(82)
`
`PFIZER, INC. v. SANOFI-AVENTIS DEUTSCHLAND GMBH
`
`Ex. 1003, p. 7 of 14
`
`

`

`U.S. Patent
`
`Mar. 31, 2015
`
`Sheet 6 of 7
`
`US 8,992,486 B2
`
`104
`
`106
`
`PFIZER, INC. v. SANOFI-AVENTIS DEUTSCHLAND GMBH
`
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`
`

`

`U.S. Patent
`
`Mar. 31, 2015
`
`Sheet 7 of 7
`
`US 8,992,486 B2
`
`100
`
`102
`
`PFIZER, INC. v. SANOFI-AVENTIS DEUTSCHLAND GMBH
`
`Ex. 1003, p. 9 of 14
`
`

`

`US 8,992,486 B2
`
`1
`PEN- TYPE IN JECTOR
`
`CROSS REFERENCE TO RELATED
`APPLICATIONS
`
`application of
`The present
`is a continuation
`application
`U.S. patent application Ser. No. 12/944, 544, filed Nov. 11,
`2010, entitled "Pen-Type Injector", which is a continuation
`application 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
`application of U.S. patent application Ser. No.
`continuation
`10/790, 225, filed Mar. 2, 2004, abandoned,
`and claims prior-
`ity to GB Patent Application No. 0304822.0, filed Mar. 3,
`2003, the entire contents of each of which are incorporated
`herein by reference.
`
`BACKGROUND
`
`in and Relating to a Pen-Type Injector
`Improvements
`The present
`invention relates to pen-type injectors,
`is
`that
`to injectors of the kind that provide
`for administration
`by
`injection ofmedicinal products from a multidose cartridge. In
`to such injectors
`relates
`the present
`invention
`particular,
`where a user may set the dose.
`Such injectors have application where regular
`injection by
`occurs. This
`is
`formal medical
`persons without
`training
`those having diabetes where
`common amongst
`increasingly
`enables such persons to conduct effective man-
`self-treatment
`agement of their diabetes.
`set a number of requirements
`These circumstances
`pen-type injectors of this kind. The injector must be robust
`construction, yet easy to use both in terms ofthe manipulation
`ofthe parts and understanding
`by a user ofits operation. In the
`case of those with diabetes, many users will be physically
`infirm and may also have impaired vision. Where the injector
`is to be disposable rather than reusable,
`the injector should be
`and easy to dispose of(preferably being
`cheap to manufacture
`suitable for recycling).
`
`for
`in
`
`Overview
`
`invention that an improved
`
`It is an advantage ofthe present
`pen-type injector is provided.
`According to a first aspect of the present
`type injector comprises a housing;
`a piston rod adapted to operate through the 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
`the drive sleeve having a helical groove of
`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;
`the drive sleeve being releasably connected to the dose dial
`sleeve and connected to the piston rod for rotation with
`respect thereto along the second threaded portion of the
`piston rod;
`a button is located on the dose dial sleeve and rotatable with
`to the dose dial sleeve; and
`respect
`
`invention,
`
`a pen-
`
`to the
`
`clutch means are provided which upon depression of the
`rotation between the dose dial sleeve and
`button permit
`the drive sleeve.
`the injector further comprises
`a nut which is
`Preferably,
`rotatable with respect to the drive sleeve and axially displace-
`to the housing.
`able but not rotatable with respect
`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
`between the first and second flanges and keyed to the housing
`stop may be
`by spline means. Additionally,
`a first
`radial
`provided on a second face of the nut and a second radial stop
`may be provided on a first face of the second 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.
`clicker
`injector
`the pen-type
`includes
`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
`saw teeth
`directed
`with a plurality
`plurality of circumferen-
`adapted to engage a corresponding
`tially 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 cor-
`circumferentially
`plurality of circumferentially
`directed saw teeth
`responding
`provided on the clutch means.
`the main housing is provided with a plurality of
`Preferably,
`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 ofthe housing. Alternatively,
`at least one ofthe maximum
`dose stops comprises a part of a raised window portion pro-
`vided at a second end of the housing.
`the dose dial sleeve is provided with a plurality
`Preferably,
`of radially extending members adapted to abut a correspond-
`ing plurality of radial stops provided at a second end of the
`housing.
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`
`The invention will now be described with reference to the
`in which:
`drawings,
`accompanying
`FIG. 1 shows a sectional view of a pen-type
`injector
`in
`accordance with the present
`invention in a first, cartridge 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;
`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;
`FIG. 6 shows a cut-away view of a first detail of the pen-
`type injector of FIG. 1;
`FIG. 7 shows a partially cut-away view of a second detail of
`the pen-type injector of FIG. 1;
`
`6
`
`10
`
`16
`
`20
`
`26
`
`30
`
`36
`
`40
`
`46
`
`60
`
`66
`
`60
`
`66
`
`PFIZER, INC. v. SANOFI-AVENTIS DEUTSCHLAND GMBH
`
`Ex. 1003, p. 10 of 14
`
`

`

`US 8,992,486 B2
`
`FIG. S shows a partially cut-away view of a third detail of
`the pen-type injector of FIG. 1;
`FIG. 9 shows the relative movement of parts of the pen-
`type injector shown in FIG. 1 during dialing up of a dose;
`FIG. 10 shows the relative movement of parts of the pen-
`type injector shown in FIG. 1 during dialing down of a dose;
`FIG. 11 shows the relative movement of parts of the pen-
`type injector shown in FIG. 1 during dispensing of a dose;
`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 ofthe main
`housing of the pen-type injector of FIG. 1.
`
`DETAILED DESCRIPTION
`
`Referring first to FIGS. 1 to 5, there may be seen a 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 fea-
`tures 6. In the illustrated embodiment,
`the cartridge 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 retain-
`ing 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 (not
`cap 14 is used to cover the cartridge
`shown). A replacable
`retaining part 2 extending from the main housing 4. Prefer-
`ably, the outer dimensions of the replaceable cap 14 are simi-
`to the outer dimensions of the main housing 4
`lar or identical
`the impression of a unitary whole when the
`to provide
`replaceable cap 14 is in position covering the cartridge retain-
`ing part 2.
`an insert 16 is provided at a
`In the illustrated embodiment,
`first end of the main housing 4. The insert 16 is secured
`rotational or longitudinal motion. The insert 16 is
`against
`provided with a threaded circular opening 1S extending there-
`the insert may be formed integrally
`through. Alternatively,
`4 the form of a radially
`with the main housing
`inwardly
`directed flange having an internal
`thread.
`A first thread 19 extends from a first end of a piston rod 20.
`The piston rod 20 is ofgenerally circular section. The 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
`from a second end of the piston rod 20. In the illus-
`extends
`the second thread 24 comprises a series of
`trated embodiment
`than a complete thread. The illustrated
`rather
`threads
`part
`is easier to manufacture
`reduce the
`embodiment
`and helps
`overall force required for a user to cause medicinal product
`to
`be dispensed.
`
`5
`
`10
`
`15
`
`20
`
`25
`
`30
`
`35
`
`40
`
`45
`
`50
`
`55
`
`60
`
`65
`
`The first thread 19 and the second thread 24 are oppositely
`disposed. The second end ofthe 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
`sleeve 30 is
`cylindrical. The drive
`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.An
`thread 36 is provided on an outer part ofthe drive
`intermediate
`sleeve 30 extending between the first flange 32 and the second
`flange 34. A helical groove 3S extends
`along the internal
`surface of the drive sleeve 30. The second thread 24 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 embodiment
`the nut 40 is
`a half-nut. This assists in the assembly ofthe injector. The nut
`thread 36.
`40 has an internal
`thread matching the intermediate
`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 relative longitu-
`therebetween.
`dinal 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
`a radially outwardly directed flange 39.
`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 and
`is provided at a first end with a flexible helically 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
`directed saw teeth 56 (cf FIG. 7). Each saw
`circumferentially
`tooth comprises
`directed surface
`a longitudinally
`and an
`inclined surface.
`the clicker
`In an alternative
`embodiment
`(not
`shown)
`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
`the drive sleeve 30. The clutch means 60 is generally cylin-
`drical and is provided at a first end with a series of circum-
`ferentially directed saw teeth 66 (see FIG. 7). Each saw tooth
`directed surface and an inclined
`comprises a longitudinally
`the second end 64 of the clutch means 60
`surface. Towards
`directed flange 62. The
`there is located a radially inwardly
`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 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 (not shown) to prevent
`relative rotation between the
`clutch 60 and the drive sleeve 30.
`the clicker 50 and the clutch
`In the illustrated embodiment,
`half the length of the drive
`60 each extend approximately
`sleeve 30. However,
`it will be understood that other arrange-
`the relative lengths of these parts are pos-
`ments
`regarding
`sible.
`
`PFIZER, INC. v. SANOFI-AVENTIS DEUTSCHLAND GMBH
`
`Ex. 1003, p. 11 of 14
`
`

`

`US 8,992,486 B2
`
`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 ofthe
`dose dial sleeve 70.
`The main housing 4 is provided with a window 44 through
`which a part ofthe outer surface ofthe dose dial sleeve may be
`seen. The main housing 4 is further provided with a helical rib
`46, adapted to be seated in the helical groove 74 on the outer
`surface of the dose dial sleeve 70. The helical rib 46 extends
`for a single sweep of the inner surface of the main housing 4.
`A first stop 100 is provided between the splines 42 and the
`rib 46 (FIG. 15).A second stop 102, disposed at an
`helical
`angle of 180' to the first stop 100 is formed by a frame
`the window 44 in the main housing 4 (FIG. 16).
`surrounding
`indication of the dose that may be
`a visual
`Conveniently,
`for example reference numerals
`is pro-
`dialed,
`(not shown),
`vided 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 ofthe dose dial sleeve 70 is provided with an
`directed flange in the form of number of radially
`inwardly
`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 corre-
`sponds to the outer diameter of the main housing 4. The dose
`dial grip 76 is secured to the dose dial sleeve 70 to prevent
`The dose dial grip 76 is
`therebetween.
`relative movement
`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.
`A button S2 of generally 'T' section is provided at a second
`end of the pen-type injector. A stem S4 of the button S2 may
`the opening 7S in the dose dial grip 76,
`extend through
`through the inner diameter of the extension 3S of the drive
`sleeve 30 and into the receiving recess 26 ofthe piston rod 20.
`The stem S4 is retained for limited axial movement
`in the
`drive sleeve 30 and against
`thereto. A
`rotation with respect
`head S5 of the button S2 is generally
`circular. A skirt S6
`from a periphery of the head S5. The skirt S6 is
`depends
`recess SO of the dose dial
`adapted to be seated in the annular
`grip 76.
`Operation of the pen-type injector in accordance with the
`invention will now be described. In FIGS. 9, 10 and 11
`present
`arrows A, B, C, D, E, F and G represent
`the respective move-
`ments 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 is
`through the saw teeth 56,66 between the clicker
`transmitted
`50 and the clutch means 60. The flexible arm 52 deforms and
`drags the toothed member 54 over the splines 42 to produce a
`click. Preferably,
`the splines 42 are disposed 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 climb
`the piston rod 20 at the same rate. At the limit oftravel, a radial
`stop 104 on the dose dial sleeve 70 engages either the first stop
`100 or the second stop 102 provided on the main housing 4 to
`
`6
`
`10
`
`16
`
`20
`
`26
`
`30
`
`36
`
`40
`
`46
`
`60
`
`66
`
`60
`
`66
`
`further movement. Rotation of the piston rod 20 is
`prevent
`due to the opposing directions of the overhauled
`prevented
`and driven threads on the piston rod 20.
`The nut 40, keyed to the main housing 4, is advanced along
`thread 36 by the rotation of the drive sleeve
`the intermediate
`30 (arrow D). When the final dose dispensed position (FIGS.
`4, 5 and 13) is reached, a radial stop 106 formed on a second
`surface of the nut 40 abuts a radial stop 10S on a first surface
`ofthe second flange 34 ofthe drive sleeve 30, preventing both
`the nut 40 and the drive sleeve 30 from rotating further.
`(not shown) a first surface of
`In an alternative
`embodiment
`the nut 40 is provided with a radial stop for abutment with a
`radial stop provided on a second surface ofthe first flange 32.
`This aids location of the nut 40 at the cartridge full position
`during assembly of the pen-type injector.
`Should a user inadvertently
`dial beyond the desired dosage,
`the dosage to be dialed down
`injector allows
`the pen-type
`dispense of medicinal
`from the cartridge
`without
`product
`(FIG. 10).The dose dial grip 76 is counter rotated. This causes
`the system to act in reverse. The flexible arm 52 now acts as a
`ratchet preventing the clicker from rotating. The torque trans-
`mitted through the clutch means 60 causes the saw teeth 56,
`66 to ride over one another
`to create the clicks corresponding
`to dialed dose reduction. Preferable the saw teeth 56, 66 are so
`extent of each saw tooth
`the circumferential
`disposed that
`to a unit dose.
`corresponds
`When the desired dose has been dialed,
`the user may then
`dispense this dose by depressing the button S2 (FIG. 11).This
`displaces the clutch means 60 axially with respect to the dose
`dial sleeve 70 causing the dog teeth 65 to disengage. However
`the clutch means 60 remains keyed in rotation to 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 overhauled
`the drive sleeve 30 from rotat-
`during dispense. This prevents
`ing with respect to the main housing 4 though it is still free to
`is sub-
`thereto. This deformation
`move axially with respect
`sequently used to urge the clicker 50, and the clutch 60, back
`along the drive sleeve 30 to restore the connection between
`the clutch 60 and the dose dial sleeve 70 when pressure
`is
`removed from the button S2.
`axial movement of the drive sleeve 30
`The longitudinal
`causes the piston rod 20 to rotate though the opening 1S in the
`insert 16, thereby to advance the piston 10 in the cartridge S.
`Once the dialed dose has been dispensed,
`the dose dial sleeve
`70 is prevented from further rotation by contact of a plurality
`of members 110 (FIG. 14) extending from the dose dial grip
`plurality of stops 112 formed in the
`76 with a corresponding
`main housing 4 (FIGS. 15 and 16).In the illustrated embodi-
`the members 110extend axially from the dose dial grip
`ment,
`76 and have an inclined end surface. The zero dose position is
`by the abutment of one of the axially extending
`determined
`edges of the members 110 with a corresponding
`stop 112.
`
`apparatus,
`
`The invention claimed is:
`1.A housing part for a medication dispensing
`said housing part comprising:
`said main housing extending from a distal
`a main housing,
`end to a proximal end;
`said dose
`a dose dial sleeve positioned within said housing,
`a helical groove configured to
`dial sleeve comprising
`engage a threading provided by said main housing;
`a dose knob disposed near a proximal end of said dose dial
`sleeve;
`
`PFIZER, INC. v. SANOFI-AVENTIS DEUTSCHLAND GMBH
`
`Ex. 1003, p. 12 of 14
`
`

`

`said clicker
`
`at
`
`shape having
`
`a dose
`
`US 8,992,486 B2
`
`10
`
`said piston rod is
`a piston rod provided within said housing,
`non-rotatable
`during a dose setting step relative to said
`main housing;
`a driver extending along a portion of said piston rod, said
`near a distal
`threading
`driver comprising
`an internal
`portion of said driver, said internal
`threading adapted to
`thread of said piston rod; and,
`engage an external
`a tubular clutch located adjacent a distal end of said dose
`knob, said tubular clutch operatively coupled to said
`dose knob,
`said dose dial sleeve extends
`circumferentially
`wherein
`around at least a portion of said tubular clutch.
`2. The housing part of claim 1, wherein said tubular clutch
`is directly coupled to said dose knob.
`3. The housing part of claim 1, wherein said main housing
`comprises a window through which at least a portion of an
`outer surface of said dose dial sleeve may be viewable.
`4. The housing part of claim 3, wherein said window is
`located near a proximal end of said main housing and near a 2p
`helical rib provided on an inner surface of said outer housing.
`5. The housing part of claim 1, wherein said driver com-
`prises a cylindrical
`shape.
`6. The housing part of claim 1, wherein said dose knob
`around at least a portion of said 25
`circumferentially
`extends
`tubular clutch.
`7. The housing part of claim 1, wherein
`a dose
`during
`step, said dose knob is activated in a distal direc-
`dispensing
`tion and said tubular clutch disengages
`such that said dose
`end of said 30
`dial sleeve rotates back towards
`said proximal
`main housing.
`S. The housing part of claim 7, wherein during said dose
`step, said dose dial sleeve and said tubular clutch
`dispensing
`rotate together.
`9. The housing part of claim 1, further comprising
`a container housing operatively coupled to said main hous-
`ing, said container housing comprising a fluid container,
`wherein said fluid container defines a medicament
`filled
`reservoir with a movable plunger at a proximal end and 4p
`an outlet at a distal end,
`said plunger movable by said piston rod to be advanced
`toward an outlet of said fluid container when said piston
`rod is moved distally, wherein
`during a dose dispensing step, said driver advances axially
`in a distal direction relative to said main housing,
`and
`said piston rod in said distal direction
`said driver advances
`so as to dispense
`from said outlet at
`said medicament
`said distal end of said fluid container.
`10.The housing part of claim 1, wherein said dose setting
`knob is coupled in part by said clutch to said dose dial sleeve
`relative movement between said dose setting
`so as to prevent
`knob and said dose dial sleeve during a dose setting step.
`11.The housing part of claim 1, wherein said dose setting
`knob is partially secured to said dose dial sleeve so as to allow 55
`relative movement between said dose setting knob and said
`dose dial sleeve during a dose dispensing
`step.
`12. The housing part of claim 1, wherein said driver com-
`prises at least one flange.
`13.The housing part of claim 12, wherein said at least one 60
`flange is located near a distal portion of said driver.
`part of claim 1, further
`14. The housing
`a
`comprising
`clicker, said clicker providing at least an audible feedback to
`a user when said dose knob is rotated.
`part of claim 14, wherein
`15. The housing
`said clicker
`tactile feedback to a user when said dose knob is
`provides
`rotated.
`
`45
`
`50
`
`65
`
`during a dose
`
`16. The housing
`part of claim 14, wherein
`said clicker
`provides audible feedback when said dose knob is rotated in
`a dose increasing direction.
`17. The housing
`part of claim 14, wherein
`said clicker
`provides audible feedback when said dose knob is rotated in
`a dose decreasing direction.
`part of claim 14, wherein
`1S. The housing
`comprises,
`at least one flexible arm, said flexible arm comprising
`least one tooth member, and
`at least one spline,
`wherein when said dose knob is rotated,
`said at least one
`flexible arm deforms and drags said tooth member over
`said at least one spline so as to provide
`said audible
`feedback.
`19. The housing part of claim 14, wherein said clicker is
`end of said
`said clutch and a proximal
`disposed between
`piston rod.
`20. The housing part of claim 14, wherein
`said clicker generally comprises a cylindrical
`a first and a second end, and
`shape is provided at said first end with at
`said cylindrical
`least one flexible extending arm.
`21. The housing part of claim 1, wherein
`said tubular clutch comprises a plurality of teeth formed
`near an end of said tubular clutch,
`said plurality of teeth remaining meshed during
`setting step, and
`said plurality of teeth becoming unmeshed
`step.
`dispensing
`22. The housing part of claim 21, wherein said plurality of
`teeth comprise a plurality of dog teeth.
`23. The housing part of claim 1, wherein said piston rod
`comprises a generally circular cross section.
`part of claim 1 wherein
`24. The housing
`said external
`thread of said piston rod comprises a part thread.
`25. The housing part of claim 1,
`said piston rod comprises
`wherein
`second thread, and
`at least one of said first or said second thread
`wherein
`than a com-
`comprises
`at least one part
`rather
`threads
`plete thread.
`26. The housing part of claim 1, wherein said dose dial
`sleeve is provided outside
`clutch and radially
`said tubular
`inward of said main housing.
`27. The housing part of claim 1, wherein said main housing
`further comprises a helical rib, said helical rib adapted to be
`seated in said helical groove provided along an outer surface
`of said dose dial sleeve.
`2S. The housing part of claim 27, wherein said helical
`rib
`extends for at least a single sweep of said inner surface of said
`main housing.
`29. The housing part of claim 27, wherein said helical
`comprises a single start helical rib.
`30. The housing part of claim 1, wherein said dose dial
`least one radial
`sleeve comprises
`stop, said radial
`at
`stop
`positioned near an end of said helical groove.
`31.The housing part of claim 30, wherein when said dose
`dial sleeve is rotated to set a maximum dose of said medica-
`stop near said end of
`tion dispensing
`said radial
`apparatus,
`said helical groove abuts an end of said threading provided on
`said inner surface of said main housing and thereby prevents
`rotation of said dose dial sleeve.
`32. The housing part of claim 30, wherein said radial stop
`is positioned near a distal end of said helica