Case 1:22-cv-00023-JPB Document 2-5 Filed 03/18/22 Page 1 of 15 PageID #: 209
`
`Exhibit E
`
`

`

`Case 1:22-cv-00023-JPB Document 2-5 Filed 03/18/22 Page 2 of 15 PageID #: 210
`IIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIII
`US008920383B2
`
`&12~ United States Patent
`Enggaard et al.
`
`(Io) Patent No. :
`(45) Date of Patent:
`
`US 8,920,383 B2
`*Dec. 30, 2014
`
`(75)
`
`(54) DOSE MECHANISM FOR AN INJECTION
`DEVICE FOR LIMITING A DOSE SETTING
`CORRESPONDING TO THE AMOUNT OF
`MEDICAMENT LEFT
`Inventors: Christian Peter Enggaard, Hillerod
`(DK); Claus Schmidt Moiler,
`Fredensborg (DK); Tom Hede
`Markussen, Bagsvaerd (DK)
`(73) Assignee: Novo Nordisk A/S, Bagsvaerd (DK)
`( * ) 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. :
`(22) PCT Filed:
`(86) PCT No. :
`) 371 (c)(I),
`Jun. 2, 2008
`(2), (4) Date:
`(87) PCT Pub. No. : WO2007/017052
`PCT Pub. Date: Feb. 15, 2007
`Prior Publication Data
`
`(65)
`
`US 2008/0243087 Al
`
`Oct. 2, 2008
`
`Related U.S.Application Data
`application No. 60/708, 618, filed on Aug.
`
`Provisional
`16, 2005.
`Foreign Application Priority Data
`
`(60)
`
`(30)
`
`(EP) .....................................
`
`JUI. 27, 2005
`Int. Cl.
`(51)
`2 61/If 5/00
`36/M 5/3/5
`36/M 5/20
`(52) U.S. Cl.
`CPC ....... 261/If 5/31583 (2013.01);36/M 5/3/57/
`(2013.01);261/If 5/31586 (2013.01);261/If
`
`(2006.01)
`(2006.01)
`(2006.01)
`
`5/31553 (2013.01);36/M 2005/202 (2013.01);
`36/M 5/20 (2013.01);36/M 5/3/593
`(2013.01);36/M 5/3/54/
`(2013.01);36/M
`5/3/56 (2013.01)
`604/207
`
`USPC
`(58) Field of ClassiTication Search
`USPC .................. 604/181, 187, 207—211, 218—231
`See application file for complete search history.
`References Cited
`
`(56)
`
`U.S. PATENT DOCUMENTS
`
`4,865,591 A
`5, 104,380 A
`
`9/1989 Sams
`4/1992 Holman et al.
`
`(Continued)
`
`FOREIGN PATENT DOCUMENTS
`
`DE
`DE
`
`20209051 Ul
`69810860
`(Continued)
`
`4/2003
`11/2003
`
`OTHER PUBLICATIONS
`
`Non-Final Office Action issued by the PTO for U.S. Appl. No.
`11/996,397 dated Dec. 31, 2008.
`
`(Continued)
`Kevin C Sirmons
`Primary Examiner
`Deanna K Hall
`Assistant Examiner
`(74) Attorney, Agent, or Firm
`Wesley A. Nicolas; Reza
`Green; Richard W. Bork
`ABSTRACT
`(57)
`setting of a dose, which exceeds
`A mechanism for preventing
`the amount of a medicament
`in an injection
`in a reservoir
`device. The device comprises a threaded piston rod, a limiter
`and a driver. The three elements are arranged such that during
`is moved towards an end-of-contend
`dose setting,
`the limiter
`position, wherein dose setting is limited. The invention com-
`and a non-accumulative
`embodiment.
`prises an accumulative
`relates to a mechanism for prevention
`The invention further
`ejection of a dose exceeding the set dose.
`
`13 Claims, 7 Drawing Sheets
`
`20-.
`10
`E6
`
`52~
`
`46
`4T
`
`4S—49
`
`

`

`Case 1:22-cv-00023-JPB Document 2-5 Filed 03/18/22 Page 3 of 15 PageID #: 211
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`US 8,920,383 B2
`Page 2
`
`References Cited
`
`U.S. PATENT DOCUMENTS
`
`5,938,642 A
`6,221,046 Bl
`6,569, 123 B2
`6,582,404 Bl *
`6,585,69g Bl
`6,663,602 B2
`2002/0120235 Al *
`2002/0165500 Al
`2005/0033244 Al
`
`g/1999
`4/2001
`5/2003
`6/2003
`7/2003
`12/2003
`g/2002
`11/2002
`2/2005
`
`Burroughs et al.
`Burroughs et al.
`Alchas et al.
`Klitgaard et al.
`Packman et al.
`Moiler
`Enggaard
`. ... ... ... .
`Bechtold et al.
`Veasey et al.
`
`FOREIGN PATENT DOCUMENTS
`
`604/20g
`
`604/I g I
`
`604/135
`
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`
`0195959 Al
`02/053214
`02/092153 A2
`03/011374 Al
`2004/007003 Al
`2004/02859g Al
`2004/030730 A2
`2004/078240 A2
`2005018721
`2006045526 Al
`2006/05ggg3
`2006076921
`2006/08976g Al
`2006/114395 Al
`2006/12532g Al
`2006/125329 Al
`
`12/2001
`7/2002
`11/2002
`2/2003
`I/2004
`4/2004
`4/2004
`9/2004
`3/2005
`5/2006
`6/2006
`7/2006
`g/2006
`11/2006
`11/2006
`11/2006
`
`DE
`DE
`EP
`EP
`EP
`EP
`EP
`JP
`JP
`RU
`RU
`SU
`WO
`WO
`WO
`WO
`WO
`
`10229122 Al
`10351596 Al
`089772g
`0937471
`937476 A2
`5016291.6
`1909870 Al
`2002-503116 A
`2005-508205 A
`20910gi Cl
`2212254 C2
`1528330 A3
`g702895 Al
`WO g7/02895
`96/27400 Al
`9938554
`01/19434 Al
`
`2/2004
`6/2005
`2/1999
`g/1999
`g/1999
`7/2005
`4/200 g
`I/2002
`3/2005
`9/1997
`9/2003
`12/1989
`5/1987
`5/1987
`9/1996
`g/1999
`3/2001
`
`OTHER PUBLICATIONS
`
`Non-Final Office Action issued by the PTO for U.S. Appl. No.
`11/996,397 dated Aug. 25, 2009.
`Final Rejection in U.S. Appl. No. 11/996,397, filed Jan. I, 200g by
`Eiland et al. Mailed Apr. 20, 2010.
`Statement by Dr. Nils Basso printed May g, 2010.
`Description of the Mechanical Components of the OPTICLIK Pen
`printed May g, 2010.
`YPSOMED AG Press Release Jan. 16, 2005 iGerman and English
`versions).
`Notice of Opposition in EP1909870 dated Dec. 12, 2011.
`Google translations of Depositions
`in Opposition of EP 1909870
`dated Dec. 12, 2011.
`* cited by examiner
`
`

`

`Case 1:22-cv-00023-JPB Document 2-5 Filed 03/18/22 Page 4 of 15 PageID #: 212
`
`U.S. Patent
`
`Dec. 30, 2014
`
`Sheet 1 of 7
`
`US 8,920,383 B2
`
`8 1
`
`2
`
`40
`58
`50
`56
`
`103P
`
`28
`
`[i
`
`

`

`Case 1:22-cv-00023-JPB Document 2-5 Filed 03/18/22 Page 5 of 15 PageID #: 213
`
`U.S. Patent
`
`Dec. 30, 2014
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`Sheet 2 of 7
`
`US 8,920,383 B2
`
`22~21
`
`25
`
`26
`
`21
`
`10
`
`FIG. 2
`
`8
`16
`
`12
`
`41
`
`

`

`Case 1:22-cv-00023-JPB Document 2-5 Filed 03/18/22 Page 6 of 15 PageID #: 214
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`U.S. Patent
`
`Dec. 30, 2014
`
`Sheet 3 of 7
`
`US 8,920,383 B2
`
`50
`
`42
`44
`46
`47
`48
`——-49
`
`36
`
`00 0 0 0
`
`s
`
`4
`
`4
`
`4
`
`~ '
`
`&4.
`
`FIG. 4
`
`20-
`10
`
`0
`
`0
`
`52~ 0
`
`

`

`Case 1:22-cv-00023-JPB Document 2-5 Filed 03/18/22 Page 7 of 15 PageID #: 215
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`U.S. Patent
`
`Dec. 30, 2014
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`Sheet 4 of 7
`
`US 8,920,383 B2
`
`8 1
`
`2
`
`(i
`
`66
`64
`68
`10
`59
`
`60
`62
`58
`
`28
`
`

`

`Case 1:22-cv-00023-JPB Document 2-5 Filed 03/18/22 Page 8 of 15 PageID #: 216
`
`U.S. Patent
`
`Dec. 30, 2014
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`Sheet 5 of 7
`
`US 8,920,383 B2
`
`10
`
`12
`
`FIG. 6
`
`

`

`Case 1:22-cv-00023-JPB Document 2-5 Filed 03/18/22 Page 9 of 15 PageID #: 217
`
`U.S. Patent
`
`Dec. 30, 2014
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`Sheet 6 of 7
`
`US 8,920,383 B2
`
`50
`
`86
`
`4
`42
`44
`62
`46
`47
`48
`---49
`
`00 00
`
`4
`
`4
`
`&4
`
`FIG. 7
`
`0000000 0
`
`66
`68
`10
`59
`
`58
`
`52~ 0
`
`18
`
`56
`
`

`

`Case 1:22-cv-00023-JPB Document 2-5 Filed 03/18/22 Page 10 of 15 PageID #: 218
`
`U.S. Patent
`
`Dec. 30, 2014
`
`Sheet 7 of 7
`
`US 8,920,383 B2
`
`96
`42
`44
`94
`
`78
`
`66
`60
`80
`84
`82
`100
`59
`10
`
`74
`
`70
`52
`
`12
`58
`68
`62
`61
`102
`
`88
`104
`90
`65
`-----98
`
`FIG. 8
`
`

`

`Case 1:22-cv-00023-JPB Document 2-5 Filed 03/18/22 Page 11 of 15 PageID #: 219
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`US 8,920,383 B2
`
`1
`DOSE MECHANISM FOR AN INJECTION
`DEVICE FOR LIMITING A DOSE SETTING
`CORRESPONDING TO THE AMOUNT OF
`MEDICAMENT LEFT
`
`CROSS-REFERENCE TO RELATED
`APPLICATIONS
`
`This application is a 35 U.S.C. )371 national
`stage appli-
`cation of International
`PCT/EP2006/
`Patent Application
`007004 (published as WO 2007/017052), filed Jul. 17, 2006,
`priority of European
`claimed
`which
`Patent Application
`05016291.6, filed Jul. 27, 2005; this
`further
`application
`claims priority under 35 U.S.C. )119 of U.S. Provisional
`Application 60/708, 618, filed Aug. 16, 2005.
`
`FIELD OF THE INVENTION
`
`invention relates to a mechanism for prevent-
`The present
`ing setting of a dose which exceeds the amount of a medica-
`in an injection device. In particular,
`in a reservoir
`the
`ment
`invention relates to a mechanism wherein the piston
`present
`rod forms part of said mechanism, whereby a compact struc-
`ture may be provided.
`
`BACKGROUND OF THE INVENTION
`
`When drugs are to be injected into the human body,
`it is
`is the actual dose
`the dose set by the user
`essential
`that
`injected. Ifthis is not the case, the medicating of the patient
`is
`not correct, which in some cases can have serious or even fatal
`In order to ensure that
`the dose selected by a
`consequences.
`dose setting member does not exceed the remaining
`amount
`of medication in a reservoir
`in a syringe device, an end-of-
`content mechanism may be provided.
`End-of content mechanisms
`are known in the art. One such
`example may be seen in WO 01/19434 Al which discloses a
`limiting mechanism for an inj ection device. A dose is injected
`by rotating a dose setting member which during this rotation
`carries a driver with it to rotate this driver which moves a
`is provided with a track having a
`piston forward. The driver
`length which is engaged by a track follower coupled to the
`dose setting mechanism.
`Another example may be seen in WO 2004/007003 A 1.
`It is an object of a preferred embodiment
`of the present
`to the above solution.
`to provide
`an alternative
`invention
`it is an object of the present
`invention to provide a
`Especially,
`surface of a driver
`to be
`an outer
`solution which allows
`directly coupled to the inner surface of a drum scale, and thus
`it is an object of the present
`invention to provide an end-of-
`content mechanism which may be positioned in the space
`defined by the inner walls of a driver.
`
`SUMMARY OF THE INVENTION
`
`and a non-
`
`The present
`invention provides an accumulative
`solution to the above problems.
`accumulative
`solution which is described below
`In the accumulative
`under a first general embodiment of the invention a limiter is
`moved stepwise closer to a stopping position wherein the
`limiter acts together with other elements of the preventing
`mechanism to ensure
`it is not possible to set a dose
`that
`exceeding the amount of medicament
`left in a reservoir.
`In the non-accumulative
`solution which is described under
`the second general embodiment of the invention the limiter is
`positioned in the same position prior to dose setting and after
`dose ejection.
`
`10
`
`15
`
`20
`
`25
`
`30
`
`35
`
`40
`
`45
`
`50
`
`55
`
`60
`
`65
`
`invention relates to a mechanism for prevent-
`The present
`ing setting of a dose which exceeds the amount of a medica-
`in an inj ection device, wherein a dose is set
`in a reservoir
`ment
`by rotating a dose setting member of a dose setting mecha-
`the mechanism comprising:
`nism,
`a piston rod having a threaded outer surface;
`a limiter defining a passage for the piston rod;
`a driver defining a passage for the limiter,
`the driver being
`such that rotation of
`coupled to the dose setting member
`the dose setting member during dose setting causes the
`driver to rotate; and
`wherein the limiter is coupled to the driver and the piston rod
`such that relative rotation between the driver and the piston
`rod during dose setting causes the limiter
`to move towards a
`setting of a
`stopping position wherein the limiter prevents
`dose which exceeds the amount of a medicament
`in a reser-
`voir in the injection device.
`The mechanism may further comprise a housing defining a
`passage for the piston rod, the passage may have a threaded
`inner surface for engagement with the threaded outer surface
`ofthe piston rod, the housing may be arranged with respect to
`the piston rod such that rotation of the piston rod,
`in relation
`to the housing, causes the piston rod to be displaced relative to
`direction. The housing may form
`the housing in a longitudinal
`part of the housing of a syringe device into which the mecha-
`nism is integrated.
`The mechanism may comprise a locking means for locking
`the piston rod against rotation in at least one direction,
`relative
`to the housing. Such a locking means may be a screw which
`may engage or disengage the piston rod. Advantageously,
`the
`screw may be arranged such that it engages a root part of the
`piston rod, whereby the walls ofthe thread and especially not
`the crest are not damaged. Alternatively,
`the locking means
`may be provided as a pivotable arm, which is operable from
`an outer surface of the device. The pivotable
`arm may be
`movable between an engaging and a non-engaging
`position,
`by means of an arm or button accessible from the outer
`surface of the syringe device.
`The mechanism may comprise a ratchet mechanism inter-
`connecting the driver and the housing. The ratchet mecha-
`nism may comprise a first and a second part. The first part may
`be coupled to the driver while the second part may be coupled
`to the housing e.g. via the locking means. The ratchet mecha-
`nism may be adapted to move in one or two rotational direc-
`tions.
`In order to assist patients with poor dexterity an ejection
`assisting system for providing an ejection force for assisting
`an operator during ejection may be provided. Such a system
`may comprise a spring which is strained when the dose setting
`is rotated during dose setting. The spring may inter-
`member
`connect the housing and the first part ofthe ratchet e.g. in such
`it co-extend the piston rod. Accordingly, when the
`a way that
`is rotated by means of the dose setting member,
`driver
`whereby the first part of the ratchet
`the spring is
`is rotated,
`strained. The potential
`stored in the
`rotationally
`energy
`strained spring is released by disengaging
`the locking means
`whereby the ratchet mechanism is free to move, whereby the
`strained spring forces the ratchet mechanism to rotate. As the
`second part of the ratchet mechanism may be locked for
`rotation in relation to the piston rod,
`the rotating ratchet
`mechanism carries the piston rod with it.
`In one embodiment
`such as one
`the spring is pre-strained,
`such as three revolutions,
`such as two revolutions,
`revolution,
`such as four revolutions,
`such as five revolutions.
`In the context of the present
`invention the term "stopping
`as engaging threads of two ele-
`thread" shall be understood
`ments, at least one of which threads prevents a first of the two
`
`

`

`Case 1:22-cv-00023-JPB Document 2-5 Filed 03/18/22 Page 12 of 15 PageID #: 220
`
`US 8,920,383 B2
`
`elements from being rotated beyond a predetermined
`position
`relative to a second of the two elements. Normally,
`said pre-
`vention of rotation is caused by engagement of surfaces of
`each of the two elements.
`In the following a first general embodiment of the invention
`is described.
`In a FIRST general
`the present
`embodiment
`invention
`setting of a dose which
`relates to a mechanism for preventing
`exceeds the amount of a medicament
`in a reservoir
`in an
`injection device, wherein
`a dose is set by rotating a dose
`setting member of a dose setting mechanism,
`the mechanism
`comprising:
`a piston rod having a threaded outer surface;
`a limiter defining a passage for the piston rod and being
`retained in relation to the piston rod,
`rotationally
`the
`limiter having a threaded outer surface;
`a passage for the limiter,
`the passage
`a driver defining
`having a threaded inner surface for engagement with the
`threaded outer surface of the limiter,
`the driver being
`coupled to the dose setting member such that rotation of
`the dose setting member during dose setting causes the
`driver to rotate; and
`wherein relative rotation between the driver and the piston rod
`to move towards
`during dose setting causes
`a
`the limiter
`setting of a
`stopping position wherein the limiter prevents
`dose which exceeds the amount of a medicament
`in a reser-
`voir in the injection device.
`Rotation of the dose setting member during dose setting
`to rotate. If the direction of rotation of the
`causes the driver
`dose setting member and the driver is the same, the driver and
`the dose setting member may be made as one single unit.
`the two elements may be made be two separate
`Alternatively,
`elements attached or coupled to each other.
`The direction of the thread of the piston rod and the driver
`i.e. if the piston rod has a right-handed
`may be opposite
`the driver has a left-handed thread and vice versa. This
`thread,
`is rotated back to the
`the dose setting member
`ensures
`that
`same position such that the user may set a dose starting from
`an initial dose of 0 IU.
`The limiter may comprise a first engaging surface adapted
`surface of the
`second engaging
`to engage a corresponding
`the limiter comprises a plurality of
`driver. In one embodiment
`surfaces which are adapted to engage corre-
`first engaging
`surfaces of the driver.
`second engaging
`In some
`sponding
`the number of first and second engaging sur-
`embodiments,
`faces is not identical. As an example there may be provided
`two first engaging surfaces while there is provided ten second
`the limiter may be locked in
`engaging surfaces. Accordingly,
`relation to each other
`in ten different positions, but at each
`position only two first and two second engaging
`surfaces
`engage each other.
`The threaded outer surface of the piston rod may comprise
`the first surface and the threaded inner surface of the driver
`the second surface. The piston rod and the driver
`comprises
`may be arranged such that relative rotational movement may
`cause the first and the second surface to be brought
`into
`relative rotational movement
`engagement, whereby further
`is
`not possible.
`the limiter may comprise a plurality of teeth
`Alternatively,
`teeth of the housing and/or
`adapted to engage corresponding
`is in the stopping position.
`the driver when the limiter
`the teeth of the limiter comprise first engag-
`Accordingly,
`ing surfaces, while the teeth of the housing and/or driver may
`comprise the second stopping surfaces.
`both teeth and a
`In one embodiment
`there is provided
`stopping thread. An advantage of this is that a larger torque
`may be transferred from the driver to the limiter, whereby it
`
`6
`
`10
`
`16
`
`20
`
`26
`
`30
`
`36
`
`40
`
`46
`
`60
`
`66
`
`60
`
`66
`
`may be ensured that even when applying a large torque to the
`a dose which exceeding the actual
`dose setting mechanism,
`left in the reservoir cannot be set. Such a larger torque
`amount
`may be between 100 and 1000Nmm, such as 250 Nmm, such
`such as 750 Nmm.
`as 500 Nmm,
`In the following a second general embodiment ofthe inven-
`tion is described.
`In a SECOND general embodiment
`the present
`invention
`setting of a dose which
`relates to a mechanism for preventing
`exceeds the amount of a medicament
`in a reservoir
`in an
`injection device, wherein a dose is set by rotating a dose
`setting member of a dose setting mechanism,
`the mechanism
`comprising:
`a piston rod having a threaded outer surface;
`a limiter defining a passage for the piston rod, the passage
`having a threaded inner surface for engagement with the
`threaded outer surface of the piston rod;
`a driver defining a passage for the limiter,
`the driver being
`rotationally retained in relation to the limiter,
`the driver
`being coupled to the dose setting mechanism such that
`rotation of the dose setting member during dose setting
`causes the driver to rotate; and
`wherein relative rotation between the driver and the piston rod
`to move towards
`during dose setting causes
`a
`the limiter
`setting of a
`stopping position wherein the limiter prevents
`dose which exceed the amount of a medicament
`in a reservoir
`in the injection device
`As described above the invention according to the second
`general embodiment of the invention is a non-accumulative
`is positioned in the same posi-
`solution, wherein the limiter
`tion (the reference position) prior to dose setting and after
`dose ejection. The limiter may comprise
`a first engaging
`surface adapted to engage a corresponding
`second engaging
`surface of the piston rod. The engaging surface of the limiter
`may be an end surface extending in a radial direction of the
`surface of a
`and facing a corresponding
`limiter
`radial
`T-shaped piston rod. Accordingly, when the piston rod is
`the two surfaces will abut each
`rotated relative to the limiter,
`the user is prevented
`from setting a higher
`other such that
`dose. In the alternative the threaded outer surface ofthe piston
`rod comprises the first surface and the threaded inner surface
`of the driver comprises
`the second surface. The two latter
`surfaces may each define a plane parallel with the axis of the
`piston rod and the limiter.
`
`DESCRIPTION OF THE DRAWINGS
`
`and the housing
`
`The invention will now be described in further detail with
`reference to the drawings,
`in which:
`FIG. 1 illustrates
`a mechanism according to the first gen-
`eral embodiment of the invention,
`teeth of the limiter
`FIG. 2 illustrates
`according to the first general embodiment,
`a cross-section through of the piston rod,
`FIG. 3 illustrates
`the limiter and the driver of FIG. 1,
`FIG. 4 illustrates
`a syringe device with injection assisting
`and a mechanism according
`to the first general
`means
`embodiment of the invention,
`FIG. 5 illustrates
`a mechanism according to the second
`general embodiment of the invention,
`FIG. 6 illustrates a cross-section through the piston rod, the
`limiter and the driver of FIG. 2,
`FIG. 7 illustrates
`a syringe device with injection assisting
`and a mechanism according to the second general
`means
`embodiment of the invention,
`and
`
`

`

`Case 1:22-cv-00023-JPB Document 2-5 Filed 03/18/22 Page 13 of 15 PageID #: 221
`
`US 8,920,383 B2
`
`FIG. S illustrates
`a syringe device according to the second
`general embodiment of the invention wherein the limiter
`is
`used both as an end-of-content
`and as a safety mechanism.
`FIG. 1 discloses syringe device 2 comprising a mechanism
`4 for preventing setting ofa dose which exceeds the amount of
`in a reservoir 6. The mechanism 4 comprises a
`a medicament
`piston rod S, a limiter 10 and a driver 12.The driver is coupled
`(not shown) such that rotation of the
`to a dose setting member
`dose setting member during dose setting, causes the driver to
`rotate in the same direction
`both when dialling
`up and
`down. The inner surface 14 of the driver 12 has a threaded
`thread of
`surface which is adapted to engage a corresponding
`the outer surface 16 ofthe limiter 10.Moreover,
`the limiter 10
`is locked for rotation in relation to the piston rod S by means
`of groove 1S in the piston rod S and a tongue 20 in the limiter
`10 (in the figure the tongue is indicated by a dotted line). Due
`the limiter 10 and the piston
`to the grove-tongue
`arrangement
`(ke. up and down in the figure)
`rod S may move translationally
`in relation to each other.
`a first set of teeth 22 adapted to
`The limiter comprises
`engage a second set of teeth 24 of the housing 26. The func-
`tion of the teeth is to ensure that the dose set does not exceed
`the amount of a medicament
`left in the reservoir 6. Further-
`more, the threads of the inner surface 14 and the outer surface
`16 comprises a stopping thread which are also used to ensure
`that that the user cannot set a dose which exceed the amount
`of a medicament
`in the reservoir. The two systems are redun-
`dant and designed to stop dose setting simultaneously.
`The syringe device further comprises a locking means 2S in
`the form of a screw, which is used to lock the piston rod S for
`rotation in relation to the housing 26. Due the threaded
`engagement 30 between the housing 26 and the piston rod S,
`locking of said two elements,
`in a transla-
`rotational
`results
`tional lock. When the locking means is in the form of a screw,
`it is desirable that the tip of the screw engages the piston rod
`such that the crest of the thread is not
`in a root of the thread,
`damaged.
`In the initial state i.e. when the pen is delivered to the user,
`the limiter 10 is located in proximal end 32 of the piston rod
`(ke. the end opposite the needle of the syringe device).
`locks the piston rod for
`to set a dose the user
`In order
`rotation by means of the locking means 2S. The dose is then
`set by rotating the driver as indicated by the arrow 34. Due to
`the relative rotational movement between the piston rod S and
`the driver 12 the limiter 10moves towards in a distal end 36 of
`the piston rod.
`When the desired dose has been set, the driver,
`the limiter
`in relation to each
`and the piston rod are locked rotationally
`other such that when a dose is ejected, they all rotate together.
`Due to the threaded engagement 30 between the housing and
`the piston rod S, the rotation ofthe piston rod causes the piston
`rod to move in the distal direction. However,
`due to the
`between the piston rod and the limiter,
`grove-tongue
`the
`translational movement of the piston rod is not transmitted to
`the limiter
`the limiter and the driver. Accordingly,
`(and the
`position.
`in the same longitudinal
`remains
`driver)
`It will be appreciated,
`each dose setting the
`that during
`limiter moves closer to the stopping position in which the first
`and second set of teeth engage and wherein the stopping
`In this position the driver cannot be rotated
`thread engage.
`further, and any torque applied to the dose setting member by
`from the dose setting member
`the user is transferred
`to the
`driver and via two torque paths. When the torque is trans-
`ferred through the first torque path 3S, it is transferred from
`to the limiter,
`through the grove-tongue
`the driver
`further
`connection to the piston rod and finally from the piston rod to
`locking means 2S. When the
`the housing, due to the rotational
`
`6
`
`10
`
`16
`
`20
`
`26
`
`30
`
`36
`
`40
`
`46
`
`60
`
`66
`
`60
`
`66
`
`torque is transferred through the second torque path 40 it is
`trans ferred from the driver to the limiter,
`from the first
`further
`set of teeth 22 to the second set of teeth 24 of the housing. By
`torque path and a second torque path it is
`a first
`providing
`possible to apply a larger torque without breaking the parts of
`the risk of user causing
`the device e.g. the teeth, and,
`thus,
`damage to the device is reduced.
`FIG. 2 shows the housing 26 comprising the second set of
`teeth 24 which are adapted to engage the first set ofteeth 22 of
`the housing. Each tooth may have a one surface 21 which is
`parallel with the axial direction of the limiter
`substantially
`and another surface 23 which is transverse to said axial direc-
`tion.
`FIG. 3 discloses
`to the grove-tongue
`an alternative
`described in connection with FIG. 1. In the alternative
`the
`piston rod S has two flat surfaces 39 and due to corresponding
`flat surfaces 41 ofthe limiter 10, the limiter and the piston rod
`are locked for relative rotational movement.
`FIG. 4 discloses a syringe device 2 comprising the mecha-
`nism 4 described in relation to FIG. 1. However,
`the syringe
`device of FIG. 4 further
`an injection assisting
`comprises
`mechanism 42 comprising
`a spring 44 interconnecting
`the
`housing 26 and a first part 46 of a ratchet mechanism 47,
`a second part 4S. When the dose
`which further comprises
`setting member 50 is rotated,
`the rotation is transferred
`to the
`driver 12 and the first part 46 of the ratchet mechanism.
`During the rotation of the dose setting member,
`the spring 44
`energy is stored. The stored
`potential
`is strained whereby
`the pawl 52 which
`energy may be released by disengaging
`during dose setting engages the second part 4S of the ratchet
`mechanism. The pawl 52 is pivotally connected to the hous-
`ing and comprises an engaging part 54 and a button part 56.
`is disengaged the strained spring 44 causes the
`When the pawl
`first part 46 to rotate. Due to the engagement between the first
`part 46 and the second part 4S, and due to the grove-tongue
`connection 49 between the second part 4S and the piston rod
`S, the rotation of the first part 46 causes the piston rod to
`rotate. As described under FIG. 1 the rotation ofthe piston rod
`causes the piston rod to move forward.
`FIG. 5 discloses the mechanism according to the second
`of the invention.
`reference
`Identical
`embodiment
`general
`In FIG. 5 the driver 12 is
`refer to identical elements.
`numbers
`coupled to a dose setting member
`such that
`(not shown)
`rotation of the dose setting member
`dose setting,
`during
`causes the driver to rotate in the same direction
`both when
`surface of the driver 12
`dialling up and down. The inner
`comprises a groove 5S which is adapted to engage a corre-
`spline 60 of the limiter 10.
`extending
`radially
`sponding
`the driver 12 and the limiter 10 are locked for
`Accordingly,
`rotational movement, while
`relative
`relative
`translational
`the limiter 10 has a
`is possible. Furthermore,
`movement
`surface 62 which engages
`a corresponding
`threaded
`inner
`threaded outer surface 64 of the piston rod S. Accordingly,
`relative rotation between the piston rod and the driver results
`between the limiter and
`in relative translational movement
`each of the piston rod and the driver.
`Unlike FIG. 1 the device of FIG. 5 does not comprise first
`and second sets of teeth. However,
`it will be appreciated that
`such sets of teeth could have been provided
`in the same
`manner as in FIG. 1. The only difference is that such sets of
`teeth should have been provided on the surface 66 and on the
`side of the limiter as the limiter moves in the
`other, upper
`direction of the proximal end 32 when a dose is set, as will be
`described in the following.
`In the initial state i.e. when the pen is delivered to the user,
`the limiter is located in a reference position wherein a surface
`61 of the limiter engages a surface 63 of the housing 26. In
`
`

`

`Case 1:22-cv-00023-JPB Document 2-5 Filed 03/18/22 Page 14 of 15 PageID #: 222
`
`US 8,920,383 B2
`
`the surfaces 61,63 are spaced apart when
`some embodiments
`is positioned in the reference position.
`the limiter
`locks the piston rod for
`to set a dose the user
`In order
`rotation by means of the locking means 2S. The dose is then
`set by rotating the driver as indicated by arrow 34. Due to the
`relative rotational movement between the piston rod S and the
`driver 12 the limiter moves towards a proximal end 32 of the
`piston rod.
`When the desired dose has been set, the driver,
`the limiter
`in relation to each
`and the piston rod are locked rotationally
`other such that, when a dose is ejected, they all rotate together.
`Due to the threaded engagement 30 between the housing and
`the piston rod S, the rotation ofthe piston rod causes the piston
`rod to move in the distal direction. Due to the grove-spline
`connection 59 between the driver and the limiter,
`the transla-
`tional movement of the piston rod is not
`to the
`transmitted
`driver. However, due to the threaded connection between the
`piston rod and the limiter,
`the limiter will move with the
`i.e. the position
`piston rod and arrive at the reference position,
`it had prior to setting the dose. Accordingly,
`as described in
`according to the second
`the aforementioned,
`the invention
`effect
`does not have the accumulative
`general embodiment
`which is seen in connection with the invention according to
`(FIG. 1-4). On the contrary the
`embodiment
`first general
`limiter returns to the reference position during ejecting of the
`set dose. This may be used to provide a safety mechanism
`adapted to prevent ejection of a dose exceeding the set dose,
`in connection with FIG. S.
`this is described in further detail
`the piston rod arrives
`At a point
`in the stopping position
`wherein a first stopping thread 66 of the thread 64 of the
`piston rod engages a second stopping thread 6S ofthe limiter.
`is that a set dose may not be increased and any
`The result
`torque applied to the driver is transferred
`to the limiter due to
`to the piston rod due
`the grove-spline-connection
`and further
`to the stopping thread and finally from the piston rod to the
`this is indicated by arrow 3S. As the piston rod is
`housing
`locked in relation to the housing by means of the locking
`rotation of the driver
`is not possible.
`means 2S, further
`FIG. 6 discloses a cross-section through the piston rod S,
`the limiter 10 and the driver 12. The limiter 10 is locked for
`relative to the driver 12 due to engage-
`rotational movement
`ment between the groove 5S and the radially extending spline
`60 of the limiter 10.
`FIG. 7 discloses a syringe device 2 comprising the mecha-
`nism 4 described in relation to FIG. 5. However,
`the syringe
`device of FIG. 6 further
`an injection assisting
`comprises
`mechanism 42 comprising
`a spring 44 interconnecting
`the
`housing 26 and a first part 46 of a ratchet mechanism 47,
`a second part 4S. When the dose
`which further comprises
`setting member 50 is rotated,
`to the
`the rotation is transferred
`driver 12 and the first part 46 of the ratchet mechanism.
`During the rotation of the dose setting member 50, the pre-
`spring 44 is strained even more whereby
`strained
`further
`potential energy is stored. The stored energy may be released
`the pawl 52 which
`dose setting
`by disengaging
`during
`the second part 4S of the ratchet mechanism. The
`engages
`pawl 52 is pivotally connected to the housing and comprises
`an engaging part 54 and a button part 56. When the pawl
`is
`disengaged the strained spring 44 causes the first part 46 to
`rotate. Due to the engagement between the first part 46 and the
`connection 49
`second part 4S, and due to the grove-tongue
`between the first part 46 and the piston rod S, the rotation of
`the first part 46 causes the piston rod to rotate. As described
`under FIG. 1 the rotation of the piston rod causes the piston
`rod to move forward.
`disclosed in FIG. S the syringe device
`In the embodiment
`ejection of a dose exceeding
`comprises means for preventing
`
`6
`
`10
`
`16
`
`20
`
`26
`
`30
`
`36
`
`40
`
`46
`
`60
`
`66
`
`60
`
`66
`
`the set dose. Said means comprises a dose limiting mecha-
`nism and a safety mechanism as will be described in detail
`below. An advantage ofthe two redundant mechanisms
`is that
`ejection of a dose
`if one fails the other may still prevent
`exceeding the set dose. The embodiment of FIG. S further
`comprises an end-of-content mechanism.
`FIG. S discloses a syringe device 2 comprising a housing 4
`and a piston rod S. The syringe device 2 further comprises a
`dose setting member 50 and a driver 12, which in the figure
`are combined into one