Case 1:22-cv-00023-JPB Document 2-10 Filed 03/18/22 Page 1 of 13 PageID #: 299
`
`
`
`
`
`Exhibit J
`
`
`
`
`
`

`

`Case 1:22-cv-00023-JPB Document 2-10 Filed 03/18/22 Page 2 of 13 PageID #: 300
`IIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIII
`US009687611B2
`
`112~ United StateS Patent
`Moeller et al.
`
`110) Patent No. :
`145) Date of Patent:
`
`US 9,687,611 B2
`*Jun. 27, 2017
`
`154)
`
`INJECTION DEVICE WITH TORSION
`SPRING AND ROTATABLE DISPLAY
`
`171) Applicant: Novo Nordisk A/S, Bagsvaerd 1DK)
`
`172)
`
`Inventors: Claus Schmidt Moeller, Fredensborg
`1DK); Tom Hede Markussen,
`Bagsvaerd 1DK); Christian Peter
`Enggaard, Vejby 1DK)
`
`173) Assignee: Novo Nordisk A/S, Bagsvaerd 1DK)
`* ) Notice:
`
`1
`
`the term of this
`Subject to any disclaimer,
`is extended or adjusted under 35
`patent
`U.S.C. 1541b) by 670 days.
`to a terminal
`is subject
`This patent
`claimer.
`
`dis-
`
`121) Appl. No. : 14/167, 558
`
`122) Filed:
`
`Jan. 29, 2014
`
`165)
`
`Prior Publication Data
`US 2014/0303563 Al
`Oct. 9, 2014
`
`Related U.S. Application Data
`163) Continuation of application No. 13/626, 541, filed on
`Sep. 25, 2012, now Pat. No. 8,684,969, which is a
`1Continued)
`
`130)
`
`Foreign Application Priority Data
`
`Oct. 21, 2004
`
`1EP) ...
`
`04077899
`
`151)
`
`Int. Cl.
`261/If 5/20
`261/If 5/315
`
`12006.01)
`12006.01)
`1Continued)
`
`152) U.S. Cl.
`CPC .... 261/If 5/31535 12013.01); 261/If 5/14566
`12013.01); 261/If 5/20 12013.01);
`1Continued)
`
`158) Field of Classification Search
`CPC .... A61M 2205/202; A61M 2205/3125; A61M
`5/20; A61M 5/3155; A61M 5/31583
`See application file for complete search history.
`
`156)
`
`References Cited
`
`U.S. PATENT DOCUMENTS
`
`4,393,723 A
`4,865,591 A
`
`7/1983 Brand
`9/1989 Sams
`1Continued)
`
`FOREIGN PATENT DOCUMENTS
`
`AU
`CA
`
`2003232576 A1
`1/2004
`2359375 A1
`7/2000
`1Continued)
`
`OTHER PUBLICATIONS
`
`Owen Mumford Product Range.
`Definition of Torsion Spring from wikipedia. org.
`
`Pri mary Examiner
`Laura Bouchelle
`174) Attorney, Agent, or Firm
`Wesley Nicolas
`
`ABSTRACT
`157)
`to an injection device com-
`The present
`relates
`invention
`connected to a dose
`a torsion spring
`operatively
`prising
`setting member being adapted to set a dose to be ejected
`from the injection device. A rotatably mounted
`display
`member adapted to display the dose to be ejected in accor-
`dance with a setting of the dose setting member
`is also
`provided. The rotatably mounted display member
`is adapted
`to be rotated over an angle corresponding
`to at
`least one
`revolution of the display member. The display member may
`be implemented
`as a dose indicator barrel having numerals
`arranged along a helical path on an outer surface thereof, or
`two or more
`device having
`as a counting
`alternatively,
`arranged on an outer
`sur-
`display wheels having numerals
`face thereof.
`
`15 Claims, 5 Drawing Sheets
`
`

`

`Case 1:22-cv-00023-JPB Document 2-10 Filed 03/18/22 Page 3 of 13 PageID #: 301
`
`US 9,687,611 B2
`Page 2
`
`Related U.S. Application Data
`continuation of application No. 11/665, 571, filed as
`on Oct. 20,
`application No. PCT/EP2005/011287
`2005, now Pat. No. 8,357,120.
`application No. 60/626, 271, filed on Nov.
`
`Provisional
`9, 2004.
`
`(60)
`
`2005/0137571 Al
`2005/0197625 Al
`2006/0258988 Al
`2009/0054839 Al
`2013/0035641 Al
`2014/0303563 Al
`2015/0025471 Al
`
`6/2005
`9/2005
`11/2006
`2/2009
`2/2013
`10/2014
`1/2015
`
`Hommann
`Haueter et al.
`Keitel et al.
`Moiler et al.
`Moiler et al.
`Moeller et al.
`Enggaard
`
`(51)
`
`(2006.01)
`(2006.01)
`
`Int. Cl.
`zf 61M 5/145
`z161M 5/31
`(52) U.S. Cl.
`zf 61M 5/3155 (2013.01); zf 61M 5/31553
`CPC ......
`(2013.01); z161M 5/31556 (2013.01); z161M
`5/31583 (2013.01); z161M 5/31593 (2013.01);
`z161M 2005/202 (2013.01); z161M 2005/3125
`(2013.01)
`
`(56)
`
`References Cited
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`U.S. PATENT DOCUMENTS
`
`5, 104,380
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`5,320,609
`5,383,856
`5,383,865
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`5,591,136
`5,599,314
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`6,666,849
`6,699,224
`6,899,699
`7,500,966
`8,357, 120
`
`A
`A
`A
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`A
`A
`A
`A
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`A
`A
`A
`A
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`A
`A
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`A
`B1
`B1
`B2
`B2
`B2
`B2 *
`
`4/1992
`4/1992
`5/1992
`7/1993
`7/1993
`3/1994
`3/1994
`5/1994
`6/1994
`1/1995
`1/1995
`1/1996
`1/1997
`2/1997
`5/1997
`3/1998
`4/1998
`10/1998
`10/1998
`7/1999
`12/1999
`4/2000
`7/2002
`12/2003
`3/2004
`5/2005
`3/2009
`1/2013
`
`Holman et al.
`Quackenbush
`Gabriel et al.
`Harris
`Gross
`Dessau et al.
`Harris
`Harris
`Haber et al.
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`Michel
`Gabriel et al.
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`Neill
`Petersen et al.
`Chanoch et al.
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`Kovelman et al.
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`Gabriel
`Kuhr et al.
`et al.
`Marshall
`Kirchhofer et al.
`Enggaard
`Hommann
`. .... ... ... ... A61M 5/14566
`Moiler
`604/135
`
`et al.
`
`8,672,898 B2
`3/2014 Enggaard
`8,684,969 B2* 4/2014 Moiler
`. .... ..
`
`2001/0053893 Al
`2002/0016571 Al
`2002/0165500 Al
`2002/0173752 Al
`
`12/2001 Larsen
`2/2002 Kirchhofer et al.
`11/2002 Bechtold et al.
`11/2002 Polzin
`
`A61M 5/14566
`604/135
`
`FOREIGN PATENT DOCUMENTS
`
`2496587 Al
`CA
`3638984 Al
`DE
`4223958 Al
`DE
`29513214 Ul
`DE
`19723647 Cl
`DE
`19838760 Al
`DE
`29907880 Ul
`DE
`10103287 Al
`DE
`10229122 Al
`DE
`20317377 Ul
`DE
`327910 A2
`EP
`338806 A2
`EP
`608343
`EP
`554996 Al
`EP
`897728
`EP
`937472 A2
`EP
`937476 A2
`EP
`1003581
`EP
`1000631
`EP
`1351732 Al
`EP
`1610848 Al
`EP
`1819382
`EP
`0007071.4
`GB
`4-224764 A
`JP
`H07-500039
`JP
`2002501790 A
`JP
`2004503303 A
`JP
`2004-516895
`JP
`2007-509662
`JP
`JP
`2007/509662 A
`2091087
`RU
`2212254
`RU
`9307922 Al
`WO
`96/32973
`WO
`9938554 Al
`WO
`01/10484
`WO
`01/19434 Al
`WO
`01/30425
`WO
`0172361 Al
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`0195959 Al
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`02/053214
`WO
`02/092152 Al
`WO
`02/092153 A2
`WO
`2004/002556 Al
`WO
`2004/024218
`WO
`2004/028598 Al
`WO
`2004/078240
`WO
`2005/046770
`WO
`2006/045528
`WO
`* cited by examiner
`
`3/2004
`5/1988
`1/1993
`1/1997
`12/1998
`4/2000
`9/2000
`8/2001
`2/2004
`4/2005
`8/1989
`10/1989
`4/1993
`8/1993
`2/1999
`8/1999
`8/1999
`8/1999
`7/2002
`10/2003
`1/2006
`8/2007
`3/2000
`8/1992
`1/1995
`1/2002
`2/2004
`6/2004
`4/2007
`4/2007
`9/1997
`9/2003
`4/1993
`10/1996
`8/1999
`2/2001
`3/2001
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`10/2001
`12/2001
`7/2002
`11/2002
`11/2002
`1/2004
`3/2004
`4/2004
`9/2004
`5/2005
`5/2006
`
`

`

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`

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`Case 1:22-cv-00023-JPB Document 2-10 Filed 03/18/22 Page 5 of 13 PageID #: 303
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`U.S. Patent
`
`Jun. 27, 2017
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`Sheet 2 of 5
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`US 9,687,611 B2
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`

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`Case 1:22-cv-00023-JPB Document 2-10 Filed 03/18/22 Page 6 of 13 PageID #: 304
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`U.S. Patent
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`Jun. 27, 2017
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`Sheet 3 of 5
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`US 9,687,611 B2
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`

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`Case 1:22-cv-00023-JPB Document 2-10 Filed 03/18/22 Page 7 of 13 PageID #: 305
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`Jun. 27, 2017
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`Sheet 4 of 5
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`US 9,687,611 B2
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`

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`Case 1:22-cv-00023-JPB Document 2-10 Filed 03/18/22 Page 8 of 13 PageID #: 306
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`U.S. Patent
`
`Jun. 27, 2017
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`Sheet 5 of 5
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`US 9,687,611 B2
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`

`

`Case 1:22-cv-00023-JPB Document 2-10 Filed 03/18/22 Page 9 of 13 PageID #: 307
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`US 9,687,611 B2
`
`1
`INJECTION DEVICE WITH TORSION
`SPRING AND ROTATABLE DISPLAY
`
`CROSS-REFERENCE TO RELATED
`APPLICATIONS
`
`This application is a continuation of U.S. application Ser.
`No. 13/626, 541, filed Sep. 25, 2012, which is a continuation
`of U.S. application Ser. No. 11/665, 571, filed Dec. 5, 2007,
`stage application of
`which is a 35 U.S.C. )371 national
`Patent Application PCT/EP2005/011287 (pub-
`International
`filed Oct. 20, 2005, which
`lished as WO 2006/045528),
`claims priority of European Patent Application 04077899.5,
`filed Oct. 21, 2004; this application
`further claims priority
`under 35 U.S.C. )119 of U.S. Provisional Application
`60/626, 271, filed Nov. 9, 2004, all of which are hereby
`by reference.
`incorporated
`
`FIELD OF THE INVENTION
`
`invention relates to an injection device, such
`The present
`indicating the dose to
`as a wind-up pen, wherein numerals
`be ejected from the injection device are displayed over an
`angle of rotation exceeding one revolution.
`In particular,
`the
`the dose to be ejected are arranged
`indicating
`numerals
`along a helical path, or alternatively,
`indicating the
`numerals
`dose to be ejected are displayed on a counting device. The
`that an increased accuracy in dose
`invention ensures
`present
`setting may be obtained.
`
`BACKGROUND OF THE INVENTION
`
`types of automatic
`injection devices have been
`Various
`described in the literature. A majority of these automatic
`injection devices apply dose indicator barrels, dose indicator
`wheels or the like which,
`dose setting,
`are only
`during
`allowed to rotate less than one single revolution. The fact
`is only allowed to rotate less
`the dose indicator barrel
`that
`during dose setting puts a limit
`to the
`than one revolution
`resolu-
`resolution. This limited angular
`obtainable
`angular
`the accuracy of the dose setting procedure.
`tion also limits
`injection
`scale
`the dose
`devices
`In prior
`art
`setting
`surface of the barrels
`or wheels
`on the outer
`arranged
`contains only up to 42 scale units with an incremental of 2.
`the accuracy when setting a dose is limited by this
`Thus,
`rough incremental.
`rather
`Examples of "one revolution"
`barrels or wheel may for
`example be found in U.S. Pat. No. 5,725,508, EP 0 338 806
`or U.S. Pat. No. 5, 104,380.
`WO 02/053214 discloses
`injection device
`an automatic
`having a dose indicator barrel capable of rotating more than
`the injection device according to
`one revolution. However,
`WO 02/053214 applies a linear spring to move a piston rod
`in the distal direction of the injection device. Evidently,
`an
`injection device applying a linear spring has a built-in axial
`and extensions of the
`due to compressions
`displacement
`linear spring along the axial direction of the injection device.
`This linear movement may easily be utilized to provide axial
`of the dose indicator barrel. However,
`it is a
`movements
`non-linear
`are highly
`in
`linear
`disadvantage
`that
`springs
`terms of force vs. compression.
`In addition,
`a linear
`spring
`looses. Thus, due to the
`relative high mechanical
`exhibits
`relating to the non-linear properties
`and relatively
`problems
`high looses there is a need for injection devices having linear
`injection assisting systems.
`and more efficient
`problems may be solved by apply-
`The above-mentioned
`ing a torsion spring instead of the linear spring. An injection
`
`device applying
`a torsion spring is conceptually
`difierent
`torsion-based
`devices in that
`from linear
`sys-
`spring-based
`tems do not have a built-in axial movement of the spring
`assisting the user in injecting a dose of medicament
`from the
`injection device. The advantages of torsion-based
`injection
`the greatest of these probably being that
`devices are many,
`over a large
`torsion springs
`in a linear manner
`respond
`working range.
`there is a need for a torsion spring-based
`injection
`Thus,
`device providing
`an improved and more user friendly dose
`It is an object of the present
`setting procedure.
`invention to
`provide such torsion spring-based injection device having an
`expanded dose scale with a high resolution.
`
`SUMMARY OF THE INVENTION
`
`object is complied with by provid-
`The above-mentioned
`in a first aspect, an injection device comprising
`ing,
`connected to a dose setting
`a torsion spring operatively
`the dose setting member being adapted to set
`member,
`a dose to be ejected from the injection device, and
`adapted to display
`a rotatably mounted
`display member
`the dose to be ejected from the injection device in
`accordance with a setting of the dose setting member,
`the rotatably mounted display member being rotatable
`over an angle corresponding
`to at least one revolution
`of the display member.
`to be moved
`The display member may be adapted
`between two end positions. These two end positions may
`define or set an axial operation range of the display member.
`The axial operation range of the display member may be
`linear working range of the
`associated with a substantially
`range of the torsion spring
`torsion spring. The working
`utilized to move the display member between the two end
`only a fraction of the available
`positions may constitute
`by the torsion spring. Thus, by
`range provided
`working
`a torsion spring only a small and linear working
`applying
`range of the available working range is utilized.
`The display member may comprise a dose indicator barrel
`arranged along a helical path on an outer
`having numerals
`surface thereof.
`According to a first embodiment of the present
`the injection device may further comprise
`a housing,
`a piston rod having a threaded outer surface with a drive
`direction of the outer
`track arranged in a longitudinal
`surface of the piston rod,
`wherein the dose setting member
`is rotatably mounted and
`defines a passage for the piston rod, the dose setting member
`further having a guiding track arranged on an inner surface
`thereof,
`a rotatable drive member being adapted to at least partly
`engage with at least part of the drive track of the piston
`rod so as to drive the piston rod,
`wherein the dose indicator barrel has a part engaging at least
`part of the guiding track of the dose setting member,
`the dose
`setting member and the dose indicator barrel being movable
`in relation to each other,
`the dose indicator barrel
`further
`having a threaded outer surface cooperating with a threaded
`inner portion of the housing whereby
`the dose indicator
`a combined
`and rotational
`barrel undergoes
`translational
`upon rotation of the
`in relation to the housing
`movement
`dose setting member,
`and
`wherein the injection device has a threaded portion cooper-
`ating with the threaded outer surface of the piston rod so that
`rotation of the piston rod relative to the housing results
`in a
`longitudinal movement of the piston rod.
`
`invention,
`
`5
`
`10
`
`20
`
`25
`
`30
`
`35
`
`40
`
`45
`
`50
`
`55
`
`60
`
`65
`
`

`

`Case 1:22-cv-00023-JPB Document 2-10 Filed 03/18/22 Page 10 of 13 PageID #: 308
`
`US 9,687,611 B2
`
`inven-
`
`is to be understood
`track dose not
`It
`the drive
`that
`length of the piston rod. For
`necessarily extend over the full
`the drive track may in some cases only extend over
`example,
`a part ofthe full length of the piston rod. Also, the drive track
`or groove
`arranged in the piston rod may be an indentation
`direction of the piston rod. Alternatively,
`in the longitudinal
`surface or two opposing
`it may also be a planar
`planar
`surfaces.
`it is to be understood that other arrangements
`in
`Similarly,
`terms of the positioning
`of the threaded
`portion of for
`example the dose indicator barrel may be arranged
`difi'er-
`ently.
`According to a second embodiment of the present
`the injection device further comprises
`tion,
`a housing,
`a piston rod having a threaded outer surface with a track
`direction of the outer surface
`arranged in a longitudinal
`of the piston rod,
`wherein the dose setting member
`is rotatably mounted and
`defines a passage for the piston rod, the dose setting member
`further having a guiding track arranged on an inner surface
`thereof,
`a rotatable drive member having a threaded portion coop-
`erating with at least part of the threaded outer surface
`of the piston rod,
`wherein the dose indicator barrel has a part engaging at least
`part of the guiding track of the dose setting member,
`the dose
`setting member and the dose indicator barrel being movable
`in relation to each other,
`the dose indicator barrel
`further
`having a threaded outer surface cooperating with a threaded
`inner portion of the housing whereby
`the dose indicator
`a combined
`and rotational
`barrel undergoes
`translational
`in relation to the housing upon rotation of the
`movement
`dose setting member,
`and
`the injection device has a portion at
`least partly
`wherein
`engaging the track of piston rod so that rotation of the drive
`to the housing
`relative
`in a longitudinal
`member
`results
`movement of the piston rod.
`The drive member may be adapted to be connected to the
`dose setting member via a ratchet. This ratchet allows
`the
`to be rotated in both directions
`dose setting member
`so that
`a given dose may be either increased or reduced. Due to the
`force provided by the torsion spring onto the ratchet,
`the
`i.e. dose
`dose setting member will remain in any position
`to which it has been brought.
`value
`The dose setting member may be adapted to be separated
`from the driving member. This separation may be achieved
`in several ways. In one way the separation may be obtained
`by a retraction of the dose setting member
`in the axial
`direction of the injection device. The retraction of the dose
`setting member must be over a distance sufficient
`to detach
`the dose setting member or the drive member
`from the teeth
`of the ratchet. Other separation mechanisms,
`such as push-
`ing the dose setting member or twisting
`the dose setting
`are also applicable.
`member
`The torsion spring may be arranged between the housing
`and the dose setting member
`in such a way that when the
`dose setting member
`is rotated around the piston rod,
`the
`torsion spring is strained. The torsion spring may be a helical
`coaxially with the piston rod, and
`spring which extends
`the housing and the dose setting mem-
`which interconnects
`ber in such a way that rotation of the dose setting member,
`the torsion spring.
`in order to set the dose, strains
`The injection device may further
`a locking
`comprise
`member adapted to fixate the piston rod in such a way that
`rotation of the piston rod and the housing
`is
`no relative
`is in its locking position.
`possible when the locking member
`
`6
`
`10
`
`16
`
`20
`
`26
`
`30
`
`36
`
`40
`
`46
`
`60
`
`66
`
`60
`
`66
`
`This fixation may be provided by a direct engagement of the
`into the track of the piston rod, or via the
`locking member
`drive member. The injection device may further comprise a
`release button adapted to release the locking member
`from
`the release button is posi-
`its locking position. Preferably,
`tioned in the distal half of the length of the injection device.
`The injection device may further comprise a first stopping
`for defining an outer position of the dose indicator
`member
`barrel. This outer position of the dose indicator barrel may
`to a maximum obtainable dose. Another outer
`correspond
`position of the dose indicator
`barrel, given by a second
`stopping member, may define a stop for providing
`further
`doses. The stopping members may form integral parts of the
`inner surface of the housing.
`In a third embodiment,
`the display member may comprise
`a counting device having two or more display wheels having
`arranged on an outer surface thereo f. In this second
`numerals
`device may have a first and a
`the counting
`embodiment
`second wheel. When the dose setting member
`is rotated,
`the
`is rotated via an optional gear mechanism,
`first wheel
`such
`as a planet gear. This first wheel may contain numerals with
`an incremental of one. The total scale on this wheel may be
`from 0 to 9. The second wheel next
`to the first wheel also
`contains numerals with an incremental of 1. However,
`this
`second wheel "counts" the number of revolutions of the first
`it "counts" the tens of the first wheel
`wheel, or alternatively,
`with an incremental of one.
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`
`view of a first
`
`invention will now be described in further
`The present
`details with reference to the accompanying
`figures, wherein
`FIG. 1 shows a cross-sectional view of a first embodiment
`of the injection device according to the present
`invention,
`FIG. 2 shows a cross-sectional
`view (rotated 90 degrees
`compared to FIG. 1) of a first embodiment of the injection
`device according to the present
`invention,
`FIG. 3 shows
`a detailed cross-sectional
`embodiment of the present
`invention,
`FIG. 4 shows a detailed cross-sectional view of a second
`embodiment of the present
`invention,
`and
`FIG. 5 shows a detailed cross-sectional
`embodiment of the present
`invention.
`a cross-section of a key in a housing
`FIG. 6 shows
`component.
`FIG. 7 shows a cross-section view of a piston rod with a
`track.
`to various modifica-
`is susceptible
`While the invention
`have been
`tions and alternative
`forms, specific embodiments
`shown by way of example
`and will be
`in the drawings
`described in detail herein. It should be understood, however,
`to the
`to be limited
`is not
`the invention
`that
`intended
`the invention is to cover
`forms disclosed. Rather,
`particular
`all modifications,
`and alternatives
`falling within
`equivalents,
`and scope of the invention
`as defined by the
`the spirit
`claims.
`appended
`
`view of a third
`
`DETAILED DESCRIPTION OF THE
`INVENTION
`
`In its most general aspect
`invention relates to
`the present
`a torsion spring in combi-
`an injection device comprising
`nation with a rotatable dose indicator mechanism capable of
`being rotated at least one revolution i.e. over an angle larger
`than 360 degrees. For example,
`the dose indicator mecha-
`(see FIGS. 1-4) or as
`nism may be implemented
`as a barrel
`interconnected wheels (see FIG. 5), the latter being operated
`
`

`

`Case 1:22-cv-00023-JPB Document 2-10 Filed 03/18/22 Page 11 of 13 PageID #: 309
`
`US 9,687,611 B2
`
`device.
`to increase
`In order
`as a counting
`the angular
`compared to known dose indicator mechanisms
`resolution
`the dose indicator mechanism of the present
`is
`invention
`rotatable over an angle of rotation corresponding
`to at least
`one revolution. The fact
`the dose to be ejected is
`that
`displayed over at least one revolution
`the dose
`allows
`that
`setting scale may contain at least 50, 60, 70, 80, 90, 100 units
`with an incremental of one.
`FIGS. 1-3 show a cross-sectional
`view of the injection
`of the present
`device
`according
`to a first
`embodiment
`invention. The dose of medicament
`to be ejected from the
`injection device is set by rotating dose setting member 1.
`The dose setting member 1 is attached to the housing 5 of the
`injection device via torsion spring 12. When the dose setting
`member 1 is rotated in order to set a dose to be ejected from
`the injection device, energy is accumulated
`in torsion spring
`12. This
`energy may be released
`by releasing
`locking
`member 4 whereby the piston rod 2 will rotate and move in
`the distal direction of the injection device. The distal move-
`ment of the piston rod 2 is caused by a rotational movement
`of the piston rod 2 itself in that
`the piston rod 2 has a
`surface. The threads of the piston rod 2
`outer
`threaded
`portion 3 of the
`and co-operate with a threaded
`engage
`injection device causing the piston rod 2 to perform the
`distal and axial movement.
`The inner surface of housing 5 of the injection device is
`provided with threads 10. These threads
`to
`are adapted
`S of a dose
`and co-operate with
`outer
`threads
`engage
`indicator barrel 9. The dose indicator barrel 9 engages with
`sliding track 11 of the dose setting member 1 in such a way
`that the dose indicator barrel 9 is able to slide in said sliding
`track 11 in an axial direction of the injection device.
`When the dose setting member 1 is rotated in order to set
`the dose indicator barrel 9 rotates with the dose
`a dose,
`setting member 1 causing the dose indicator barrel 9 to be
`to the housing 5. A window is
`axially displaced relative
`provided in the housing 5 of the injection device. Through
`the user of the injection device may view the
`this window,
`actual dose setting level
`(not shown) pro-
`from numerals
`vided on an exterior surface of the dose indicator barrel 9.
`The numerals
`are arranged along a helical path.
`An advantage of having the numerals
`along a
`arranged
`helical-like path is that a higher angular
`resolution is obtain-
`able when a dose is to be set. Due to this higher
`angular
`a dose can be set with a significantly
`resolution
`higher
`accuracy. This greater accuracy is obtained since the helical-
`for more numerals
`to be arranged
`like path allows
`on the
`dose indicator barrel 9 compared to numerals
`arranged at the
`same height on the surface of the dose indicator barrel 9.
`When a dose has been ejected from the injection device,
`the dose indicator barrel 9 is adapted to be rotated back to
`its initial position and it is thereby ready to be set to a new
`dose. The same applies
`for an injection device applying
`a
`counting device as a dose meter.
`the piston rod 2 has a threaded
`As already mentioned,
`surface. This
`outer
`surface
`outer
`threaded
`and
`engages
`co-operates with a threaded portion 3 of the injection device.
`The piston rod 2 is driven by the drive member
`6 that
`engages a track in piston rod 2. The axial movement of the
`piston rod 2 is provided
`by rotating piston rod 2 in the
`threaded portion 3 of the injection device. Drive member 6
`may be locked by the locking member 4. In its locked
`In order
`position, drive member 6 is prevented from rotating.
`the user of the injection
`to release the drive member
`6,
`push button 15 whereby
`device may activate a spring-loaded
`drive member 6 causes the piston rod 2 to rotate in threaded
`part 3 of the housing whereby the piston rod 2 rotates and
`
`5
`
`10
`
`15
`
`20
`
`25
`
`30
`
`35
`
`40
`
`45
`
`50
`
`55
`
`60
`
`65
`
`in the distal direction of the injection device. Thus,
`travels
`the injection device
`when the drive member 6 is released,
`ejects automatically.
`the dose indicator
`ejection,
`During
`to zero dose.
`barrel
`returns
`The dose setting member 1 and the drive member 6 are
`ratchet 13.
`connected
`via a self-tightening
`mechanically
`ratchet 13 has
`saw-toothed
`the self-tightening
`Preferably,
`teeth with approximately
`vertical
`as the
`oriented
`flanks
`flanks.
`sel f-tightening
`In order to reset or reduce an already set dose,
`the dose
`setting member 1 is arranged to be axially retractable over
`to the height of the teeth of the
`a distance corresponding
`one-way ratchet 13.Thus, by pulling the dose setting mem-
`ber 1 back, and thereby disengage the dose setting member
`1 from the drive member
`set dose can be
`6, an already
`reduced or even reset. The amount of reduction obviously
`depends on the angle of rotation (in the opposite rotation
`direction as when a dose is set) of the dose setting member
`1.
`
`ratchet may be formed as a separate
`The self-tightening
`component having first and second engaging parts. Alterna-
`tively, one of these parts may form an integral part of the
`dose setting member 1, or alternatively,
`the
`an integral part
`drive member 6.
`FIG. 4 shows a second embodiment of the present
`inven-
`tion. Compared to the first embodiment,
`the drive member 6
`has a threaded portion cooperating with the threaded outer
`surface of the piston rod 2. The main difl'erence compared to
`the piston rod 2 is no longer
`is that
`the first embodiment
`rotatable relative to the housing 5. This non-rotatable
`rela-
`tionship is ensured in that the housing of the injection device
`the track 7 of
`has a key 14 which at
`least partly engages
`piston rod 2. Thus, when the drive member 6 is free to rotate
`to the housing 5 the piston rod 2 will undergo
`relative
`a
`along the axial direction of the
`translational movement
`injection device.
`FIG. 5 shows a third embodiment of the present
`invention.
`the dose indicator barrel of the first and
`In this embodiment
`has been replaced by a counting device
`second embodiment
`having two wheels 15, 16. In principle the number of wheels
`for
`may be chosen arbitrary,
`a counting
`but
`simplicity,
`in FIG. 5. The
`device having only two wheels
`is illustrated
`follows: When the dose
`device is operated
`as
`counting
`setting member 1 is rotated,
`the wheel closest
`to the dose
`setting member 15 is rotated via an optional planet gear 17.
`This wheel contains numerals with an incremental of one.
`The total scale on this wheel may contain 10 units distrib-
`uted over a scale from 0 to 9, or alternatively,
`the total scale
`may contain for example 20 units distributed over two scales
`each having a scale from 0 to 9.
`The second wheel 16 next
`to the first wheel 15 also
`contains numerals with an incremental of 1. However,
`this
`second wheel "counts" the number of revolutions of the first
`it "counts" the tens of the first wheel
`wheel, or alternatively,
`with an incremental of one. Alternatively,
`the second wheel
`"counts" the number of half resolutions of the first wheel
`in
`case the first wheel contains a scale having 20 units.
`
`claimed is:
`The invention
`1. An injection device comprising:
`connected to a dose
`(12) operatively
`a torsion spring
`(1) being
`(1), the dose setting member
`setting member
`adapted to set a dose to be ejected from the injection
`the torsion spring storing energy necessary to
`device,
`drive a dose of medication from the injection device,
`in the spring during a
`wherein energy is accumulated
`dose setting operation,
`and
`
`

`

`Case 1:22-cv-00023-JPB Document 2-10 Filed 03/18/22 Page 12 of 13 PageID #: 310
`
`US 9,687,611 B2
`
`to claim 2,
`
`further
`
`device
`
`according
`
`adapted to display
`a rotatably mounted
`display member
`the dose to be ejected from the injection device in
`accordance with a setting of the dose setting member
`(1), the rotatably mounted display member being rotat-
`to at least one revo-
`able over an angle corresponding
`lution of the display member, wherein
`the display
`is a barrel
`engaged with a
`member
`that
`is threadedly
`device housing
`and wherein the barrel moves axially
`and in a proximal direction during the setting of a dose
`injection of a dose and
`and moves
`distally
`during
`wherein the barrel rotates toward a zero position during
`injection.
`2. An injection device according to claim 1, wherein the
`is adapted to be moved between two end
`display member
`said two end positions defining an operation range
`positions,
`of the display member,
`said operation range being associated
`range of the torsion
`with a substantially
`linear working
`spring.
`3. An injection device according to claim 1, wherein the
`display member comprises a dose indicator barrel (9) having
`arranged along a helical path on an outer surface
`numerals
`thereof.
`4. An injection device according to claim 1, wherein the
`display member comprises a counting device having two or
`arranged on an outer
`more display wheels having numerals
`surface thereof.
`5. An injection
`comprising:
`a housing
`(5),
`a piston rod (2) having a threaded outer surface with a
`direction of
`drive track (7) arranged in a longitudinal
`said outer surface,
`(1) is rotatably mounted
`wherein the dose setting member
`and defines a passage for the piston rod (2), the dose setting
`(1) further having a guiding track (11) arranged on
`member
`an inner surface thereof,
`(6) being adapted to at
`a rotatable drive member
`least
`partly engage with at least part of the drive track (7) of
`the piston rod (2) so as to drive the piston rod,
`wherein the dose indicator barrel
`(9) has a part engaging at
`least part of the guiding
`track (11) of the dose setting
`(1) and the dose
`(1), the dose setting member
`member
`indicator barrel (9) being movable in relation to each other,
`the dose indicator barrel (9) further having a threaded outer
`surface (S) cooperating with a threaded inner portion (10) of
`the housing (5) whereby the dose indicator barrel (9) under-
`goes a combined translational
`in
`and rotational movement
`relation to the housing (5) upon rotation of the dose setting
`(1), and
`member
`wherein the injection device has a threaded portion (3)
`surface of the
`outer
`cooperating with the threaded
`rotation of the piston rod (2)
`piston rod (2) so that
`to the housing
`relative
`in a longitudinal
`(5) results
`movement of the piston rod (2).
`6. An injection
`to claim 1, further
`device
`according
`comprising a threaded piston rod that moves distally during
`injection of a dose and a release that releases energy from the
`the energy from the spring driving a dose from the
`spring,
`injection device.
`7. An injection device according to claim 5, wherein the
`(6) is adapted to be connected to the dose
`drive member
`(1) via a ratchet (13).
`setting member
`S. An injection device according to claim 5, wherein the
`torsion spring (12) is arranged between the housing (5) and
`the dose setting member (1) in such a way that when the dose
`(1) is rotated around the piston rod (2), the
`setting member
`torsion spring (12) is strained.
`
`9. An injection device according to claim S, wherein the
`spring which extends coaxi-
`torsion spring (12) is a helical
`ally with the piston rod (2).
`10. An injection device according
`to claim 5, further
`(4) adapted to fixate the piston
`comprising a locking member
`rod (2) in such a way that no relative rotation between of the
`piston rod (2) and the housing
`(5) is possible when the
`(4) is in its locking position.
`locking member
`11. An injection device according to claim 10, further
`a release button adapted to release the locking
`comprising
`(4) from its locking position.
`member
`12.An injection device according to claim 11,wherein the
`release button is positioned in the distal half of the length of
`the injection device.
`13. An injection device according
`to claim 5, further
`for defining an outer position
`comprising a stopping member
`of the dose indicator barrel (9), the outer position of the dose
`to a maximum obtainable
`indicator barrel (9) corresponding
`dose.
`14. An injection pen comprising:
`a housing;
`for setting a dose, the dose setting
`a dose setting member
`member mounted to the housing so that
`it may rotate
`the dose setting member being
`relative to the housing,
`capable of rotated in two directions,
`one direction to
`increase the size of a dose and another
`to decrease the
`size of the dose;
`a dose indicator barrel having a helical scale, wherein the
`dos