Case 1:22-cv-00023-JPB Document 2-11 Filed 03/18/22 Page 1 of 16 PageID #: 312
`
`
`
`
`
`Exhibit K
`
`
`
`
`
`

`

`Case 1:22-cv-00023-JPB Document 2-11 Filed 03/18/22 Page 2 of 16 PageID #: 313
`IIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIII
`US009775953B2
`
`&12~ United States Patent
`Enggaard et al.
`
`(10) Patent No. :
`(45) Date of Patent:
`
`US 9,775,953 B2
`*Oct. 3, 2017
`
`(54) DOSE MECHANISM FOR AN INJECTION
`DEVICE FOR LIMITING A DOSE SETTING
`CORRESPONDING TO THE AMOUNT OF
`MEDICAMENT LEFT
`
`(71) Applicant: Novo Nordisk A/S, Bagsvaerd (DK)
`
`(72)
`
`Inventors: Christian Peter Enggaard, Vejby
`(DK); Claus Schmidt Moiler,
`(DK); Tom Hede
`Fredensborg
`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 92 days.
`to a terminal
`
`This patent
`claimer.
`
`is subject
`
`dis-
`
`(52) U.S. Cl.
`CPC .... A61/If 5/31551 (2013.01); A61/If 5/31505
`(2013.01); A61/If 5/31526 (2013.01);
`(Continued)
`(58) Field of Classification Search
`CPC .......... A61M 5/31526; A61M 5/31528; A61M
`5/31541; A61M 5/31551; A61M 5/3156;
`(Continued)
`
`(56)
`
`References Cited
`
`U.S. PATENT DOCUMENTS
`
`4,498,904 A
`4,865,591 A
`
`2/1985 Turner et al.
`9/1989 Sams
`(Continued)
`
`FOREIGN PATENT DOCUMENTS
`
`DE
`
`20209051 Ul
`4/2003
`69810860 T2
`11/2003
`(Continued)
`
`OTHER PUBLICATIONS
`
`Non-Final Otfrce 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 Nicolas
`ABSTRACT
`(57)
`setting of a dose, which
`A mechanism for preventing
`exceeds the amount of a medicament
`in a reservoir
`in an
`injection device. The device can contain a threaded piston
`can be
`and a driver. The three
`rod, a limiter
`elements
`arranged such that during dose setting,
`is moved
`the limiter
`towards an end-of-content
`position, wherein dose setting is
`limited. The invention
`and a
`an accumulative
`contains
`The
`non-accumulative
`embodiment.
`further
`invention
`ejection of a dose
`to a mechanism for preventing
`relates
`exceeding the set dose.
`
`25 Claims, 7 Drawing Sheets
`
`(21) Appl. No. : 14/550, 085
`
`(22)
`
`Filed:
`
`Nov. 21, 2014
`
`(65)
`
`Prior Publication Data
`
`US 2015/0080812 Al
`
`Mar. 19, 2015
`
`Related U.S. Application Data
`(63) Continuation of application No. 11/996,409, filed as
`application No. PCT/EP2006/007004
`on Jul. 17,
`2006, now Pat. No. 8,920,383.
`(Continued)
`
`(30)
`
`Foreign Application Priority Data
`
`JUI. 27, 2005
`
`(EP)
`
`05016291
`
`(51)
`
`Int. Cl.
`A 61/If 5/00
`A 61/If 5/315
`A6/M 5/20
`
`(2006.01)
`(2006.01)
`(2006.01)
`
`20.
`10
`16
`
`52~
`
`46
`42
`48
`—49
`
`

`

`Case 1:22-cv-00023-JPB Document 2-11 Filed 03/18/22 Page 3 of 16 PageID #: 314
`
`US 9,775,953 B2
`Page 2
`
`(60)
`
`Related U.S. Application Data
`application No. 60/708, 618, filed on Ang.
`Provisional
`16, 2005.
`
`(52) U.S. Cl.
`zf 61M 5/31528 (2013.01); zf 61M 5/31553
`CPC ....
`(2013.01); zf 61M 5/31583 (2013.01); zf 61M
`5/31586 (2013.01); zI61M 5/20 (2013.01);
`zI61M 5/3156 (2013.01); zI61M 5/31541
`(2013.01); zI61M 5/31571 (2013.01); zI61M
`5/31593 (2013.01); zI61M 2005/202 (2013.01);
`zI 61M 2005/3151 (2013.01)
`(58) Field of Classification Search
`CPC .......... A61M 5/31583; A61M 5/31586; A61M
`5/31593
`. 604/207 —211
`USPC
`See application file for complete search history.
`
`(56)
`
`References Cited
`
`U.S. PATENT DOCUMENTS
`
`4,883,472 A
`5, 104,380 A
`5,921,966 A
`5,938,642 A *
`
`11/1989
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`6,221,046
`6,221,053
`6,235,004
`6,248,095
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`6,585,698
`6,663,602
`6,699,224
`6,899,699
`7, 104,972
`7, 169,132
`7, 195,616
`7,309,327
`7,500,966
`7,553,299
`7,686,786
`7,811,263
`7,828,779
`8,096,978
`8,444, 606
`8,721,601
`8,920,383
`
`BI
`4/2001
`BI
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`BI
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`BI
`6/2001
`B2
`5/2003
`BI
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`BI
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`B2
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`B2
`5/2013
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`5/2014
`B2 * 12/2014
`
`Michel
`Holman et al.
`Bendek et al.
`.. ... ... A61M 5/31551
`Burroughs
`604/208
`
`et al.
`
`et al.
`Burroughs
`Walters et al.
`Steenfeldt-Jensen
`et al.
`Giambattista
`Alchas et al.
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`Packman et al.
`Muller
`Kirchhofer et al.
`Enggaard
`Moiler et al.
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`Diller et al.
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`Veasey et al.
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`Burren et al.
`Kirchhofer et al.
`Markussen
`Radmer
`Burren et al.
`. ... ... ... A61M 5/31553
`Enggaard
`604/207
`
`2002/0120235
`2002/0165500
`2005/0033244
`2005/0261634
`2006/0270985
`2008/0208142
`2008/0221530
`
`Al
`A I
`Al
`Al
`A I
`Al
`Al
`
`8/2002
`11/2002
`2/2005
`11/2005
`11/2006
`8/2008
`9/2008
`
`Enggaard
`Bechtold et al.
`Veasey et al.
`Karlsson
`Hommann
`Moiler
`Glejbol et al.
`
`et al.
`
`FOREIGN PATENT DOCUMENTS
`
`DE
`DE
`EP
`EP
`EP
`EP
`EP
`EP
`JP
`JP
`RU
`RU
`SU
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`
`10229122 Al
`10351596 Al
`897728
`897729 A2
`0937471
`937476 A2
`5016291.6
`1909870 Al
`2002-503116 A
`2005-508205 A
`2091087 Cl
`2212254 C2
`1528330 A3
`8702895 Al
`96/27400 Al
`2006/114395 Al
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`01/19434 Al
`0195959 Al
`02/053214
`02/092153 A2
`03/011374 Al
`2004/007003 Al
`2004/028598 Al
`2004/030730 A2
`2004/078240 A2
`2005018721
`2006045526 Al
`2006/058883
`2006076921
`2006/089768 Al
`2006/125328 Al
`2006/125329 Al
`
`2/2004
`6/2005
`2/1999
`2/1999
`8/1999
`8/1999
`7/2005
`4/2008
`I/2002
`3/2005
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`9/2003
`12/1989
`5/1987
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`8/1999
`8/1999
`3/2001
`12/2001
`7/2002
`11/2002
`2/2003
`I/2004
`4/2004
`4/2004
`9/2004
`3/2005
`5/2006
`6/2006
`7/2006
`8/2006
`11/2006
`11/2006
`
`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, 2008 by
`Eiland et al, mailed Apr. 20, 2010.
`Statement by Dr. Nils Basso printed May 8, 2010.
`Description of the Mechanical Components of the OPTICLIK Pen
`printed May 8, 2010.
`Ypsomed AG Press Release Jan. 16, 2005 iGerman and English
`versions).
`Anlage E23 Eidesstattliche Versichemng Herr Peter Ryser.
`Anlage E24 Eidesstattliche Versicherung Herr Nicolas Binggeli.
`Anlage E25 Eidesstattliche Versichemng
`Frau Daniela Moser.
`Durch Die
`Injektionsvorrichtung
`Ofienkundige
`Vorbenutzung
`"Flexpen" E20a-c.
`Anlage E26 iFig. 101.
`Notice of Opposition in EP1909870 dated Dec. 12, 2011.
`English Abstract of DE202009051 Published Apr. 24, 2003.
`Google Translation of Affidavit by Dr. Nils Basso.
`* cited by examiner
`
`

`

`Case 1:22-cv-00023-JPB Document 2-11 Filed 03/18/22 Page 4 of 16 PageID #: 315
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`U.S. Patent
`
`Oct. 3, 2017
`
`Sheet 1 of 7
`
`US 9,775,953 B2
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`8 1
`
`2
`
`40
`58
`50
`56
`
`103P
`
`28
`
`(i
`
`

`

`Case 1:22-cv-00023-JPB Document 2-11 Filed 03/18/22 Page 5 of 16 PageID #: 316
`
`U.S. Patent
`
`Oct. 3, 2017
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`Sheet 2 of 7
`
`US 9,775,953 B2
`
`22Q
`
`21
`
`10
`
`8
`16
`
`FIG. 2
`
`41
`FIG. 3
`
`

`

`Case 1:22-cv-00023-JPB Document 2-11 Filed 03/18/22 Page 6 of 16 PageID #: 317
`
`U.S. Patent
`
`Oct. 3, 2017
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`Sheet 3 of 7
`
`US 9,775,953 B2
`
`50
`
`12
`
`42
`44
`
`47
`48
`---49
`
`00 0000
`
`0
`
`0
`
`20-
`10
`16
`
`22
`
`52~ 0
`
`18
`
`56
`
`26
`
`4 ' 4
`
`e
`
`4:
`
`4
`
`e
`
`4
`
`4
`
`

`

`Case 1:22-cv-00023-JPB Document 2-11 Filed 03/18/22 Page 7 of 16 PageID #: 318
`
`U.S. Patent
`
`Oct. 3, 2017
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`Sheet 4 of 7
`
`US 9,775,953 B2
`
`8 1
`
`2
`
`(i
`
`66
`64
`68
`10
`59
`
`60
`62
`58
`
`28
`
`

`

`Case 1:22-cv-00023-JPB Document 2-11 Filed 03/18/22 Page 8 of 16 PageID #: 319
`
`U.S. Patent
`
`Oct. 3, 2017
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`Sheet 5 of 7
`
`US 9,775,953 B2
`
`10
`
`12
`
`FIG. 6
`
`

`

`Case 1:22-cv-00023-JPB Document 2-11 Filed 03/18/22 Page 9 of 16 PageID #: 320
`
`U.S. Patent
`
`Oct. 3, 2017
`
`Sheet 6 of 7
`
`US 9,775,953 B2
`
`50
`
`12
`
`86
`
`4
`42
`44
`62
`46
`47
`48
`
`30
`
`00 00000 0
`
`0000000
`
`66
`68
`10
`59
`
`52~
`
`26
`
`4
`
`4
`
`4
`
`FIG. 7
`
`

`

`Case 1:22-cv-00023-JPB Document 2-11 Filed 03/18/22 Page 10 of 16 PageID #: 321
`
`U.S. Patent
`
`Oct. 3, 2017
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`Sheet 7 of 7
`
`US 9,775,953 B2
`
`96
`42
`44
`94
`72
`78
`
`66
`60
`80
`84
`82
`100
`59
`10
`
`50
`
`74
`
`70
`32
`
`12
`58
`68
`62
`61
`102
`
`88
`104
`90
`63
`--——-98
`
`64
`
`FIG. 8
`
`

`

`Case 1:22-cv-00023-JPB Document 2-11 Filed 03/18/22 Page 11 of 16 PageID #: 322
`
`US 9,775,953 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 continuation of U.S. application Ser.
`No. 11/996,409 filed Jan. 22, 2008, which is a 35 U.S.C.
`of International
`)371 national
`Patent
`application
`stage
`Application PCT/EP2006/007004
`as WO 2007/
`(published
`017052), filed Jul. 17, 2006, which claimed priority of
`05016291.6,
`filed Jul. 27,
`Patent Application
`European
`under 35
`2005;
`claims
`application
`further
`this
`priority
`U.S.C. )119 of U.S. Provisional Application
`60/708, 618,
`filed Aug. 16, 2005, the contents of which are incorporated
`herein by reference.
`
`FIELD OF THE INVENTION
`
`invention relates to a mechanism for prevent-
`The present
`ing setting of a dose which
`of a
`exceeds
`the amount
`in an injection device. In particu-
`in a reservoir
`medicament
`invention relates to a mechanism wherein the
`lar, the present
`piston rod forms part of said mechanism, whereby a compact
`structure 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. If this is not the case, the medicating of the patient
`is not correct, which in some cases can have serious or even
`In order to ensure that
`the dose selected
`fatal consequences.
`by a 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
`in the art. One
`are known
`such example may be seen in WO 01/19434 Al which
`discloses a limiting mechanism for an injection device. A
`dose is injected by rotating a dose setting member which
`rotation carries a driver with it to rotate this
`this
`during
`driver which moves a piston forward. The driver
`is provided
`with a track having a length which is engaged by a track
`follower coupled to the dose setting mechanism.
`example may be seen in WO 2004/007003 Al.
`Another
`U.S. Pat. No. 5,938,642 disclose
`an injection
`device
`comprising a driver, a nut and a threaded piston rod. During
`dose setting the nut
`screwed up the threaded
`is rotational
`piston rod and during dosing the nut and the piston rod is
`the same distance. Once the nut
`axial
`forward
`brought
`reaches the end of the thread of the threaded piston rod no
`further dose can be set.
`It is an object of a preferred embodiment
`of the present
`to provide
`to the above solution.
`an alternative
`invention
`it is an object of the present
`invention to provide
`Especially,
`a solution which allows an outer surface of a driver
`to be
`surface of a drum scale, and
`directly coupled to the inner
`it is an object of the present
`to provide
`an
`invention
`thus
`end-of-content mechanism which may be positioned in the
`space defined by the inner walls of a driver.
`
`SUMMARY OF THE INVENTION
`
`invention provides a non-accumulative
`The present
`tion to the above problems.
`
`solu-
`
`In an accumulative
`solution which is described below
`is moved stepwise closer
`under a first example,
`the limiter
`to a stopping position wherein the limiter acts together with
`other elements of the preventing mechanism to ensure that
`to set a dose exceeding the amount of
`is not possible
`it
`left in a reservoir.
`medicament
`In the non-accumulative
`is described
`solution which
`the second example,
`is positioned in the
`the limiter
`under
`same position prior to dose setting and after dose ejection.
`invention relates to a mechanism for prevent-
`The present
`ing setting of a dose which
`the amount of a
`exceeds
`in an injection device, wherein a
`in a reservoir
`medicament
`a dose setting member of a dose
`dose is set by rotating
`the mechanism comprising:
`setting mechanism,
`a piston rod having a threaded outer surface;
`for the piston rod,
`the
`a housing
`a passage
`defining
`surface for engage-
`a threaded
`inner
`passage having
`ment with the threaded outer surface of the piston rod,
`to the piston
`the housing being arranged with respect
`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 in a longitudinal
`a limiter defining a passage for the piston rod;
`a driver defining a passage for the limiter,
`the driver being
`coupled to the dose setting member
`such that rotation
`of the dose setting member during dose setting causes
`to rotate; and
`the driver
`is coupled to the driver and the piston
`wherein the limiter
`rod such that
`rotation between the driver and the
`relative
`piston rod during dose setting causes the limiter
`to move
`a stopping
`the limiter prevents
`towards
`position wherein
`setting of a dose which exceeds the amount of a medicament
`in the injection device.
`in a reservoir
`The housing may form part of the housing of a syringe
`device into which the mechanism is integrated.
`for lock-
`The mechanism may comprise a locking means
`ing the piston rod against
`rotation in at least one direction,
`to the housing. Such a locking means may be a
`relative
`screw which may engage or disengage
`the piston rod.
`the screw may be arranged
`it
`such that
`Advantageously,
`engages a root part of the piston rod, whereby the walls of
`the crest are not damaged.
`not
`the thread and especially
`the locking means may be provided
`as a
`Alternatively,
`pivotable arm, which is operable from an outer surface of the
`device. The pivotable
`arm may be movable
`between
`an
`position, by means of an arm
`engaging and a non-engaging
`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
`e.g. via the locking means. The
`coupled to the housing
`ratchet mechanism may be adapted to move in one or two
`rotational directions.
`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
`a spring which is strained when the dose
`may comprise
`is rotated during dose setting. The spring
`setting member
`the housing and the first part of the ratchet
`may interconnect
`e.g. in such a way that
`it co-extend the piston rod. Accord-
`ingly, when the driver is rotated by means of the dose setting
`member, whereby the first part of the ratchet
`is rotated,
`the
`strained. The potential energy stored in
`spring is rotationally
`the strained spring is released by disengaging
`the locking
`the ratchet mechanism is free to move,
`means whereby
`
`5
`
`10
`
`15
`
`20
`
`30
`
`35
`
`40
`
`45
`
`50
`
`55
`
`60
`
`65
`
`

`

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`US 9,775,953 B2
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`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.
`such as one
`In one example
`the spring is pre-strained,
`such as three revolu-
`such as two revolutions,
`revolution,
`tions, such as four revolutions,
`such as five revolutions.
`In the context of the present
`invention the term "stopping
`threads of two
`thread"
`shall be understood
`as engaging
`elements, at least one of which threads prevents a first of the
`from being rotated beyond a predetermined
`two elements
`position relative to a second of the two elements. Normally,
`of rotation
`of
`is caused by engagement
`said prevention
`surfaces of each of the two elements.
`In the following a first general example is described.
`The FIRST general
`example relates to a mechanism for
`setting of a dose which exceeds the amount of a
`preventing
`in an injection device, wherein a
`in a reservoir
`medicament
`a dose setting member of a dose
`dose is set by rotating
`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,
`a driver defining
`the passage
`surface for engagement with
`having a threaded
`inner
`surface of the limiter,
`outer
`the threaded
`the driver
`being coupled to the dose setting member
`such that
`rotation of the dose setting member during dose setting
`to rotate; and
`causes the driver
`wherein relative rotation between the driver and the piston
`to move towards
`rod during dose setting causes the limiter
`setting of a
`a stopping position wherein the limiter prevents
`the amount of a medicament
`exceeds
`dose which
`in a
`in the injection device.
`reservoir
`Rotation of the dose setting member during dose setting
`to rotate. If the direction of rotation of the
`causes the driver
`dose setting member
`is the same,
`and the driver
`the driver
`and the dose setting member may be made as one single unit.
`the two elements may be made be two sepa-
`Alternatively,
`attached or coupled to each other.
`rate elements
`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
`thread and vice versa.
`the driver has a left-handed
`thread,
`is rotated back to
`the dose setting member
`This ensures that
`the user may set a dose starting
`the same position such that
`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
`a plurality of
`In one example the limiter comprises
`driver.
`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 surfaces
`examples,
`is not identical. As an example there may be provided two
`surfaces while there is provided ten second
`first engaging
`the limiter may be locked in
`engaging surfaces. Accordingly,
`relation to each other in ten difi'erent 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
`further
`engagement, whereby
`is not possible.
`
`5
`
`10
`
`15
`
`20
`
`25
`
`30
`
`35
`
`40
`
`45
`
`50
`
`55
`
`60
`
`65
`
`the limiter may comprise a plurality of teeth
`Alternatively,
`teeth of the housing and/or
`adapted to engage corresponding
`position.
`is in the stopping
`the driver when the limiter
`the teeth of the limiter comprise first engaging
`Accordingly,
`surfaces, while the teeth of the housing and/or driver may
`comprise the second stopping surfaces.
`In one example there is provided both teeth and a stopping
`thread. An advantage of this is that a larger
`torque may be
`transferred from the driver to the limiter, whereby it may be
`a large torque to the dose
`ensured that even when applying
`a dose which
`exceeding
`actual
`setting mechanism,
`the
`cannot be set. Such a larger
`in the reservoir
`left
`amount
`torque may be between 100 and 1000 Nmm,
`such as 250
`such as 750 Nmm.
`such as 500 Nmm,
`Nmm,
`In the following a second general example is described.
`The SECOND general
`to a mechanism
`relates
`example
`setting of a dose which exceeds the amount
`for preventing
`of a medicament
`in an injection device,
`in a reservoir
`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
`surface for engagement with
`having a threaded
`inner
`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
`to rotate; and
`causes the driver
`wherein relative rotation between the driver and the piston
`to move towards
`rod during dose setting causes the limiter
`setting of a
`a stopping position wherein the limiter prevents
`exceed the amount of a medicament
`dose which
`in a
`in the injection device
`reservoir
`As described above the invention according to the second
`example of the invention
`is a non-accumulative
`general
`is positioned
`same
`solution, wherein
`the limiter
`in the
`position (the reference position) prior
`to dose setting and
`after dose ejection.
`The limiter may comprise a first engaging surface adapted
`surface of the
`second engaging
`to engage a corresponding
`surface of the limiter may be an
`piston rod. The engaging
`end surface extending in a radial direction of the limiter and
`surface of a T-shaped piston
`facing a corresponding
`radial
`rod. Accordingly, when the piston rod is rotated relative to
`the two surfaces will abut each other such that
`the limiter,
`a higher dose.
`In the
`the user
`from setting
`is prevented
`surface of the piston rod
`outer
`the threaded
`alternative
`the first surface and the threaded inner surface of
`comprises
`the second surface. The two latter
`comprises
`the driver
`surfaces may each define a plane parallel with the axis of the
`piston rod and the limiter.
`
`DESCRIPTION OF THE DRAWINGS
`
`to the first
`
`The invention will now be described in further detail with
`reference to the drawings,
`in which:
`FIG. 1 illustrates
`a mechanism according
`general example of the invention,
`teeth of the limiter
`FIG. 2 illustrates
`according to the first general example,
`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
`example of the invention,
`
`and the housing
`
`

`

`Case 1:22-cv-00023-JPB Document 2-11 Filed 03/18/22 Page 13 of 16 PageID #: 324
`
`US 9,775,953 B2
`
`FIG. 5 illustrates
`a mechanism according to the second
`general example 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
`example of the invention,
`and
`FIG. S illustrates
`a syringe device according to the second
`general example of the invention wherein the limiter
`is used
`both as an end-of-content
`and as a safety mechanism.
`FIG. 1 discloses
`a mecha-
`syringe device 2 comprising
`setting of a dose which exceeds the
`nism 4 for preventing
`amount of a medicament
`in a reservoir 6. The mechanism 4
`a piston rod S, a limiter 10 and a driver 12. The
`comprises
`driver is coupled to a dose setting member
`such
`(not shown)
`that rotation of the 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 surface which is adapted to engage a corre-
`thread of the outer surface 16 of the limiter 10.
`sponding
`the limiter 10 is locked for rotation in relation to
`Moreover,
`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 to the grove-tongue
`arrange-
`the limiter 10 and the piston rod S may move trans-
`ment
`in relation to each
`lationally (ke. up and down in the figure)
`other.
`a first set of teeth 22 adapted to
`The limiter comprises
`a second set of teeth 24 of the housing 26. The
`engage
`function of the teeth is to ensure that
`the dose set does not
`exceed the amount of a medicament
`left in the reservoir 6.
`the threads of the inner
`surface 14 and the
`Furthermore,
`outer surface 16 comprises a stopping thread which are also
`set a dose which
`the user cannot
`used to ensure that
`that
`exceed the amount of a medicament
`in the reservoir. The two
`to stop dose setting
`are redundant
`and designed
`systems
`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 trans-
`rotational
`results
`is in the form of a
`lock. When the locking means
`lational
`the tip of the screw engages
`it is desirable
`the
`that
`screw,
`piston rod in a root of the thread,
`the crest of the
`such that
`thread is not 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
`between the piston rod
`to the relative rotational movement
`S and the driver 12 the limiter 10 moves 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
`a dose is ejected,
`rotate
`other
`such that when
`they all
`30 between the
`together. Due to the threaded
`engagement
`housing and the piston rod S, the rotation of the piston rod
`causes the piston rod to move in the distal direction. How-
`ever, due to the grove-tongue between the piston rod and the
`the translational movement of the piston rod is not
`limiter,
`to the limiter
`the
`and the driver. Accordingly,
`transmitted
`(and the driver)
`in the same longitudinal
`limiter
`remains
`position.
`
`6
`
`10
`
`16
`
`20
`
`26
`
`30
`
`36
`
`40
`
`46
`
`60
`
`66
`
`60
`
`66
`
`It will be appreciated,
`that during each dose setting the
`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.
`and any torque applied to the dose setting member
`further,
`from the dose setting member
`to
`by the user is transferred
`is
`and via two torque paths. When the torque
`the driver
`transferred through the first torque path 3S, it is transferred
`to the limiter,
`the grove-
`from the driver
`further
`through
`connection to the piston rod and finally from the
`tongue
`piston rod to the housing,
`due to the rotational
`locking
`means 2S. When the torque is transferred through the second
`torque path 40 it is transferred from the driver to the limiter,
`from the first set of teeth 22 to the second set of teeth
`further
`24 of the housing. By providing
`a first
`torque path and a
`second torque path it is possible to apply a larger
`torque
`without breaking the parts of the device e.g. the teeth, and,
`the risk of user causing
`to the device
`is
`damage
`thus,
`reduced.
`FIG. 2 shows the housing 26 comprising the second set of
`teeth 24 which are adapted to engage the first set of teeth 22
`of the housing. Each tooth may have a one surface 21 which
`parallel with the axial direction of the limiter
`is substantially
`surface 23 which is transverse
`to said axial
`and another
`direction.
`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 correspond-
`ing flat surfaces 41 of the 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.
`the syringe device of FIG. 4 further comprises
`However,
`an injection assisting mechanism 42 comprising a spring 44
`the housing 26 and a first part 46 of a ratchet
`interconnecting
`a second part 4S.
`mechanism 47, which further
`comprises
`When the dose 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 is strained whereby potential
`energy is stored.
`The stored energy may be released by disengaging
`the
`pawl 52 which during dose setting engages
`the second part
`4S of the ratchet mechanism. The pawl 52 is pivotally
`connected to the housing and comprises an engaging part 54
`and a button part 56. When the pawl
`the
`is disengaged
`strained spring 44 causes the first part 46 to rotate. Due to
`the engagement between the first part 46 and the second part
`connection 49 between the
`4S, and due to the grove-tongue
`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 of the piston rod causes the piston rod to
`move forward.
`FIG. 5 discloses the mechanism according to the second
`general example of the invention.
`reference num-
`Identical
`In FIG. 5 the driver 12 is
`bers refer to identical
`elements.
`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,
`relative
`relative
`rotational movement, while
`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
`
`

`

`Case 1:22-cv-00023-JPB Document 2-11 Filed 03/18/22 Page 14 of 16 PageID #: 325
`
`US 9,775,953 B2
`
`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 difi'erence 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,
`is located in a reference position wherein
`a
`the limiter
`surface 61 of the limiter engages a surface 63 of the housing
`26. In some examples
`the surfaces 61,63 are spaced apart
`is positioned in the reference position.
`when 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
`between the piston rod S
`the relative rotational movement
`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
`such that, when a dose is ejected,
`rotate
`other
`they all
`30 between the
`together. Due to the threaded
`engagement
`housing and the piston rod S, the rotation of the piston rod
`causes the piston rod to move in the distal direction. Due to
`connection 59 between the driver and the
`the grove-spline
`the translational movement of the piston rod is not
`limiter,
`to the driver. However,
`due to the threaded
`transmitted
`connection between the piston rod and the limiter,
`the limiter
`will move with the piston rod and arrive at the reference
`i.e. the position it had prior
`to setting the dose.
`position,
`the inven-
`as described in the aforementioned,
`Accordingly,
`tion according to the second general example does not have
`efi'ect which is seen in connection with the
`the accumulative
`invention according to first general example (FIG. 1-4). On
`to the reference position
`the limiter
`the contrary
`returns
`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,
`this is described in further detail
`in
`connection with FIG. S.
`the piston rod arrives
`At a point
`in the stopping position
`wherein a first stopping thread 66 of the thread 64 of the
`thread 6S of the
`piston rod engages
`a second stopping
`is that a set dose may not be increased and
`limiter. The result
`is transferred to the limiter
`any torque applied to the driver
`to the piston
`due to the grove-spline-connection
`and further
`rod due to the stopping thread and finally from the piston rod
`this is indicated by arrow 3S. As the piston
`to the housing
`by means of the
`rod is locked in relation to the housing
`rotation of the driver
`is not
`locking means 2S,
`further
`possible.
`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
`the groove 5S and the radially
`ment between
`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. Howe