Case 1:22-cv-00023-JPB Document 2-4 Filed 03/18/22 Page 1 of 14 PageID #: 195
`
`
`
`
`
`Exhibit D
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`
`
`
`
`

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`Case 1:22-cv-00023-JPB Document 2-4 Filed 03/18/22 Page 2 of 14 PageID #: 196
`I 1111111111111111 11111 1111111111 1111111111 1111111111 111111111111111 IIII IIII
`US008684969B2
`
`c12) United States Patent
`Moller et al.
`
`(IO) Patent No.:
`(45) Date of Patent:
`
`US 8,684,969 B2
`* Apr. 1, 2014
`
`(54)
`
`INJECTION DEVICE WITH TORSION
`SPRING AND ROTATABLE DISPLAY
`
`(71) Applicant: Novo NordiskA/S, Bagsvaerd (DK)
`
`(72)
`
`Inventors: Claus Schmidt Moller, Fredensborg
`(DK); Tom Hede Markussen,
`Bagsvaerd (DK); Christian Peter
`Enggaard, Vejby (DK)
`
`(73) Assignee: Novo NordiskA/S, Bagsvaerd (DK)
`
`( *) Notice:
`
`Subject to any disclaimer, the term ofthis
`patent is extended or adjusted under 35
`U.S.C. 154(b) by O days.
`
`This patent is subject to a terminal dis(cid:173)
`claimer.
`
`AU
`CA
`
`(58)
`
`Field of Classification Search
`USPC ......... 604/131, 134,135,181, 207-211, 218,
`604/224, 189
`See application file for complete search history.
`
`(56)
`
`References Cited
`
`U.S. PATENT DOCUMENTS
`
`4,393,723 A
`4,865,591 A
`5,104,380 A
`
`7/1983 Brand
`9/1989 Sams
`4/1992 Holman et al.
`(Continued)
`
`(21) Appl. No.: 13/626,541
`
`(22) Filed:
`
`Sep.25,2012
`
`(65)
`
`Prior Publication Data
`
`US 2013/0035641 Al
`
`Feb. 7, 2013
`
`Related U.S. Application Data
`
`(63) Continuation of application No. 11/665,571, filed as
`application No. PCT/EP2005/011287 on Oct. 20,
`2005, now Pat. No. 8,357,120.
`
`(60) Provisional application No. 60/626,271, filed on Nov.
`9, 2004.
`
`(30)
`
`Foreign Application Priority Data
`
`Oct. 21, 2004
`
`(EP) ..................................... 04077899
`
`(51)
`
`Int. Cl.
`A61M5/20
`(52) U.S. Cl.
`USPC ........................................... 604/135; 604/207
`
`(2006.01)
`
`FOREIGN PATENT DOCUMENTS
`
`1/2004
`2003232576 Al
`7/2000
`2359375 Al
`(Continued)
`
`OTHER PUBLICATIONS
`
`Owen Mumford Product Range.
`
`Primary Examiner - Laura Bouchelle
`(74) Attorney, Agent, or Firm - Marc A. Began
`
`ABSTRACT
`(57)
`The present invention relates to an injection device compris(cid:173)
`ing a torsion spring operatively connected to a dose 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 accordance 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 alternatively, as a
`counting device having two or more display wheels having
`numerals arranged on an outer surface thereof.
`
`26 Claims, 5 Drawing Sheets
`
`

`

`Case 1:22-cv-00023-JPB Document 2-4 Filed 03/18/22 Page 3 of 14 PageID #: 197
`
`US 8,684,969 B2
`Page 2
`
`(56)
`
`References Cited
`
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`
`FOREIGN PATENT DOCUMENTS
`
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`
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`
`DE
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`DE
`EP
`EP
`EP
`EP
`EP
`EP
`EP
`EP
`EP
`EP
`EP
`EP
`GB
`JP
`JP
`JP
`JP
`JP
`JP
`JP
`RU
`RU
`WO
`WO
`WO
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`WO
`WO
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`WO
`WO
`WO
`WO
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`WO
`WO
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`WO
`WO
`
`10103287 Al
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`0007071.4
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`2007/509662 A
`2091087
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`02/053214
`02/092152 Al
`2002/092153 A2
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`2004/078240
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`2006/045528
`
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`2/2004
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`10/1989
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`5/2005
`5/2006
`
`* cited by examiner
`
`

`

`Case 1:22-cv-00023-JPB Document 2-4 Filed 03/18/22 Page 4 of 14 PageID #: 198
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`U.S. Patent
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`Apr.1, 2014
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`Sheet 1 of 5
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`US 8,684,969 B2
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`J2
`2
`
`10
`
`'
`
`3
`1/
`
`I I~
`Ii !
`I'
`I 11/!
`
`I
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`i
`
`f/11
`,if/
`'1/'
`!I I ./
`1·
`
`'
`
`7-
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`l:3,
`
`:Fig.1
`
`Fig. 2
`
`

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`Case 1:22-cv-00023-JPB Document 2-4 Filed 03/18/22 Page 5 of 14 PageID #: 199
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`U.S. Patent
`
`Apr.1, 2014
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`Sheet 2 of 5
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`US 8,684,969 B2
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`Fig. 3
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`

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`Case 1:22-cv-00023-JPB Document 2-4 Filed 03/18/22 Page 6 of 14 PageID #: 200
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`U.S. Patent
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`Apr.1, 2014
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`Sheet 3 of 5
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`US 8,684,969 B2
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`0
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`:Fig. 4
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`

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`Case 1:22-cv-00023-JPB Document 2-4 Filed 03/18/22 Page 7 of 14 PageID #: 201
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`U.S. Patent
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`Apr.1, 2014
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`Sheet 4 of 5
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`US 8,684,969 B2
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`[fil
`
`:Fig. 5
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`

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`Case 1:22-cv-00023-JPB Document 2-4 Filed 03/18/22 Page 8 of 14 PageID #: 202
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`U.S. Patent
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`Apr.1, 2014
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`Sheet 5 of 5
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`US 8,684,969 B2
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`Figo 6
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`

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`Case 1:22-cv-00023-JPB Document 2-4 Filed 03/18/22 Page 9 of 14 PageID #: 203
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`US 8,684,969 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. 11/665,571, filed Dec. 5, 2007, which is a 35 U.S.C. §371
`national stage application oflntemational Patent Application
`PCT/EP2005/011287 (published as WO 2006/045528), filed
`Oct. 20, 2005, which 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. Provi(cid:173)
`sional Application 60/626,271, filed Nov. 9, 2004, all of
`which are hereby incorporated by reference.
`
`FIELD OF THE INVENTION
`
`5
`
`2
`terns 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
`devices are many, the greatest of these probably being that
`torsion springs respond in a linear manner over a large work(cid:173)
`ing range.
`Thus, there is a need for a torsion spring-based injection
`device providing an improved and more user friendly dose
`setting procedure. It is an object of the present invention to
`10 provide such torsion spring-based injection device having an
`expanded dose scale with a high resolution.
`
`SUMMARY OF THE INVENTION
`
`15
`
`The present invention relates to an injection device, such as
`a wind-up pen, wherein numerals indicating the dose to be 20
`ejected from the injection device are displayed over an angle
`of rotation exceeding one revolution. In particular, the numer-
`als indicating the dose to be ejected are arranged along a
`helical path, or alternatively, numerals indicating the dose to
`be ejected are displayed on a counting device. The present 25
`invention ensures that an increased accuracy in dose setting
`may be obtained.
`
`BACKGROUND OF THE INVENTION
`
`Various types of automatic injection devices have been
`described in the literature. A majority of these automatic
`injection devices apply dose indicator barrels, dose indicator
`wheels or the like which, during dose setting, are only
`allowed to rotate less than one single revolution. The fact that
`the dose indicator barrel is only allowed to rotate less than one
`revolution during dose setting puts a limit to the obtainable
`angular resolution. This limited angular resolution also limits
`the accuracy of the dose setting procedure.
`In prior art injection devices the dose setting scale arranged 40
`on the outer surface of the barrels or wheels contains only up
`to 4 2 scale units with an incremental of 2. Thus, the accuracy
`when setting a dose is limited by this rather rough incremen(cid:173)
`tal.
`Examples of "one revolution" barrels or wheel may for 45
`example be found in U.S. Pat. No. 5,725,508, EP0338 806 or
`U.S. Pat. No. 5,104,380.
`WO 02/053214 discloses an automatic injection device
`having a dose indicator barrel capable of rotating more than
`one revolution. However, the injection device according to 50
`WO 02/053214 applies a linear spring to move a piston rod in
`the distal direction of the injection device. Evidently, an injec(cid:173)
`tion device applying a linear spring has a built-in axial dis(cid:173)
`placement due to compressions and extensions of the linear
`spring along the axial direction of the injection device. This
`linear movement may easily be utilized to provide axial
`movements of the dose indicator barrel. However, it is a
`disadvantage that linear springs are highly non-linear in terms
`of force vs. compression. In addition, a linear spring exhibits
`relative high mechanical looses. Thus, due to the problems
`relating to the non-linear properties and relatively high looses
`there is a need for injection devices having linear and more
`efficient injection assisting systems.
`The above-mentioned problems may be solved by applying
`a torsion spring instead of the linear spring. An injection
`device applying a torsion spring is conceptually different
`from linear spring-based devices in that torsion-based sys-
`
`The above-mentioned object is complied with by provid(cid:173)
`ing, in a first aspect, an injection device comprising
`a torsion spring operatively connected to a dose setting
`member, the dose setting member being adapted to set a
`dose to be ejected from the injection device, and
`a rotatably mounted display member adapted to display the
`dose to be ejected from the injection device in accor(cid:173)
`dance 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.
`The display member may be adapted to be moved 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 associated
`30 with a substantially linear working range of the torsion
`spring. The working range of the torsion spring utilized to
`move the display member between the two end positions may
`constitute only a fraction of the available working range pro(cid:173)
`vided by the torsion spring. Thus, by applying a torsion spring
`35 only a small and linear working range of the available work(cid:173)
`ing range is utilized.
`The display member may comprise a dose indicator barrel
`having numerals arranged along a helical path on an outer
`surface thereof.
`According to a first embodiment of the present invention,
`the injection device may further comprise
`a housing,
`a piston rod having a threaded outer surface with a drive
`track arranged in a longitudinal direction of the outer
`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
`55 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 barrel
`undergoes a combined translational and rotational movement
`60 in relation to the housing upon rotation of the dose setting
`member, and
`wherein the injection device has a threaded portion cooper(cid:173)
`ating with the threaded outer surface of the piston rod so that
`rotation of the piston rod relative to the housing results in a
`65 longitudinal movement of the piston rod.
`It is to be understood that the drive track dose not neces(cid:173)
`sarily extend over the full length of the piston rod. For
`
`

`

`Case 1:22-cv-00023-JPB Document 2-4 Filed 03/18/22 Page 10 of 14 PageID #: 204
`
`US 8,684,969 B2
`
`4
`button adapted to release the locking member from its locking
`position. Preferably, the release button is positioned in the
`distal half of the length of the injection device.
`The injection device may further comprise a first stopping
`5 member for defining an outer position of the dose indicator
`barrel. This outer position of the dose indicator barrel may
`correspond to a maximum obtainable dose. Another outer
`position of the dose indicator barrel, given by a second stop(cid:173)
`ping member, may define a stop for providing further doses.
`10 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
`numerals arranged on an outer surface thereof. In this second
`15 embodiment the counting device may have a first and a sec(cid:173)
`ond wheel. When the dose setting member is rotated, the first
`wheel is rotated via an optional gear mechanism, 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
`20 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 wheel,
`or alternatively, it "counts" the tens of the first wheel with an
`incremental of one.
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`
`3
`example, the drive track may in some cases only extend over
`a part of the full length of the piston rod. Also, the drive track
`arranged in the piston rod may be an indentation or groove in
`the longitudinal direction of the piston rod. Alternatively, it
`may also be a planar surface or two opposing planar surfaces.
`Similarly, it is to be understood that other arrangements in
`terms of the positioning of the threaded portion of for
`example the dose indicator barrel may be arranged differ(cid:173)
`ently.
`According to a second embodiment of the present inven(cid:173)
`tion, the injection device further comprises
`a housing,
`a piston rod having a threaded outer surface with a track
`arranged in a longitudinal direction of the outer 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 having a threaded portion coop(cid:173)
`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 25
`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 barrel
`undergoes a combined translational and rotational movement
`in relation to the housing upon rotation of the dose setting 30
`member, and
`wherein the injection device has a portion at least partly
`engaging the track of piston rod so that rotation of the drive
`member relative to the housing results in a longitudinal move(cid:173)
`ment 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
`dose setting member to be rotated in both directions so that a
`given dose may be either increased or reduced. Due to the
`force provided by the torsion spring onto the ratchet, the dose
`setting member will remain in any position-i.e. dose
`value-to which it has been brought.
`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 45
`retraction of the dose setting member in the axial direction of
`the injection device. The retraction of the dose setting mem(cid:173)
`ber 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 pushing the 50
`dose setting member or twisting the dose setting member are
`also applicable.
`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 55
`spring is strained. The torsion spring may be a helical spring
`which extends coaxially with the piston rod, and which inter(cid:173)
`connects the housing and the dose setting member in such a
`way that rotation of the dose setting member, in order to set
`the dose, strains the torsion spring.
`The injection device may further comprise a locking mem(cid:173)
`ber adapted to fixate the piston rod in such a way that no
`relative rotation of the piston rod and the housing is possible
`when the locking member is in its locking position. This
`fixation may be provided by a direct engagement of the lock- 65
`ing member into the track of the piston rod, or via the drive
`member. The injection device may further comprise a release
`
`35
`
`The present invention will now be described in further
`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 view of a first
`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 view of a third
`40 embodiment of the present invention.
`FIG. 6 shows a cross-section of a key in a housing compo-
`nent.
`FIG. 7 shows a cross-section view of a piston rod with a
`track.
`While the invention is susceptible to various modifications
`and alternative forms, specific embodiments have been
`shown by way of example in the drawings and will be
`described in detail herein. It should be understood, however,
`that the invention is not intended to be limited to the particular
`forms disclosed. Rather, the invention is to cover all modifi(cid:173)
`cations, equivalents, and alternatives falling within the spirit
`and scope of the invention as defined by the appended claims.
`
`DETAILED DESCRIPTION OF THE INVENTION
`
`In its most general aspect the present invention relates to an
`injection device comprising a torsion spring in combination
`with a rotatable dose indicator mechanism capable of being
`rotated at least one revolution-i.e. over an angle larger than
`60 3 60 degrees. For example, the dose indicator mechanism may
`be implemented as a barrel (see FIGS. 1-4) or as intercon(cid:173)
`nected wheels (see FIG. 5), the latter being operated as a
`counting device. In order to increase the angular resolution
`compared to known dose indicator mechanisms the dose indi(cid:173)
`cator mechanism of the present invention is rotatable over an
`angle of rotation corresponding to at least one revolution. The
`fact that the dose to be ejected is displayed over at least one
`
`

`

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`US 8,684,969 B2
`
`6
`erably, the self-tightening ratchet 13 has saw-toothed teeth
`with approximately vertical oriented flanks as the self-tight(cid:173)
`ening flanks.
`In order to reset or reduce an already set dose, the dose
`5 setting member 1 is arranged to be axially retractable over a
`distance corresponding to the height of the teeth of the one(cid:173)
`way ratchet 13. Thus, by pulling the dose setting member 1
`back, and thereby disengage the dose setting member 1 from
`the drive member 6, an already set dose can be reduced or
`10 even reset. The amount ofreduction obviously depends on the
`angle of rotation (in the opposite rotation direction as when a
`dose is set) of the dose setting member 1.
`The self-tightening ratchet may be formed as a separate
`component having first and second engaging parts. Alterna-
`15 tively, one of these parts may form an integral part of the dose
`setting member 1, or alternatively, an integral part the drive
`member 6.
`FIG. 4 shows a second embodiment of the present inven(cid:173)
`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 difference compared to
`the first embodiment is that the piston rod 2 is no longer
`rotatable relative to the housing 5. This non-rotatable rela(cid:173)
`tionship is ensured in that the housing of the injection device
`has a key 14 which at least partly engages the track 7 of piston
`rod 2. Thus, when the drive member 6 is free to rotate relative
`to the housing 5 the piston rod 2 will undergo a translational
`movement along the axial direction of the injection device.
`FIG. 5 shows a third embodiment of the present invention.
`In this embodiment the dose indicator barrel of the first and
`second embodiment has been replaced by a counting device
`having two wheels 15, 16. In principle the number of wheels
`may be chosen arbitrary, but for simplicity, a counting device
`having only two wheels is illustrated in FIG. 5. The counting
`35 device is operated as follows: When the dose 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 distributed over a scale from Oto
`9, or alternatively, the total scale may contain for example 20
`units distributed over two scales each having a scale from Oto
`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 wheel,
`or alternatively, it "counts" the tens of the first wheel 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.
`
`5
`revolution allows that the dose 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
`device according to a first embodiment of the present inven(cid:173)
`tion. 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 movement of the
`piston rod 2 is caused by a rotational movement of the piston
`rod 2 itselfin that the piston rod 2 has a threaded outer surface.
`The threads of the piston rod 2 engage and co-operate with a
`threaded portion 3 of the 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 20
`provided with threads 10. These threads are adapted to engage
`and co-operate with outer threads 8 of a dose 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 indi(cid:173)
`cator barrel 9 is able to slide in said sliding track 11 in an axial 25
`direction of the injection device.
`When the dose setting member 1 is rotated in order to set a
`dose, the dose indicator barrel 9 rotates with the dose setting
`member 1 causing the dose indicator barrel 9 to be axially
`displaced relative to the housing 5. A window is provided in 30
`the housing 5 of the injection device. Through this window,
`the user of the injection device may view the actual dose
`setting level from numerals (not shown) provided on an exte(cid:173)
`rior surface of the dose indicator barrel 9. The numerals are
`arranged along a helical path.
`An advantage of having the numerals arranged along a
`helical-like path is that a higher angular resolution is obtain(cid:173)
`able when a dose is to be set. Due to this higher angular
`resolution a dose can be set with a significantly higher accu(cid:173)
`racy. This greater accuracy is obtained since the helical-like 40
`path allows for more numerals to be arranged 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 45
`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.
`As already mentioned, the piston rod 2 has a threaded outer
`surface. This threaded outer surface engages and co-operates 50
`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 position, drive member 6 is prevented from
`rotating. In order to release the drive member 6, the user of the
`injection device may activate a spring-loaded push button 15
`whereby drive member 6 causes the piston rod 2 to rotate in 60
`threaded part 3 of the housing whereby the piston rod 2 rotates
`and travels in the distal direction of the injection device. Thus,
`when the drive member 6 is released, the injection device
`ejects automatically. During ejection, the dose indicator bar(cid:173)
`rel returns to zero dose.
`The dose setting member 1 and the drive member 6 are
`mechanically connected via a self-tightening ratchet 13. Pref-
`
`The invention claimed is:
`1. An injection device comprising -pl a torsion spring (12)
`operatively connected to a dose setting member (1), the dose
`setting member (1) being adapted to set a dose to be ejected
`55 from the injection device, and
`a rotatably mounted display member adapted to display the
`dose to be ejected from the injection device in accor(cid:173)
`dance with a setting of the dose setting member (1), the
`rotatably mounted display member being rotatable over
`an angle corresponding to at least one revolution of the
`display member, wherein the rotatably mounted display
`comprises a dose indicator barrel;
`wherein the display member is adapted to be moved between
`two end positions, said two end positions defining an opera-
`65 tion range of the display member, said operation range being
`associated with a substantially linear working range of the
`torsion spring;
`
`

`

`Case 1:22-cv-00023-JPB Document 2-4 Filed 03/18/22 Page 12 of 14 PageID #: 206
`
`US 8,684,969 B2
`
`7
`wherein the injection device further comprises:
`a housing (5),
`a piston rod (2) having a threaded outer surface with a drive
`track (7) arranged in a longitudinal direction of said
`outer surface,
`wherein the dose setting member (1) is rotatably mounted and
`defines a passage for the piston rod (2), the dose setting
`member (1) further having a guiding track (11) arranged on an
`inner surface thereof,
`a rotatable drive member ( 6) being adapted to at least partly 10
`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 member
`(1 ), the dose setting member (1) and the dose indicator barrel
`(9) being movable in relation to each other, the dose indicator
`barrel (9) further having a threaded outer surface (8) cooper(cid:173)
`ating with a threaded inner portion (10) of the housing (5)
`whereby the dose indicator barrel (9) undergoes a combined 20
`translational and rotational movement in relation to the hous(cid:173)
`ing (5) upon rotation of the dose setting member (1), and
`wherein the injection device has a threaded portion (3) coop(cid:173)
`erating with the threaded outer surface of the piston rod (2) so
`that rotation of the piston rod (2) relative to the housing (5)
`results in a longitudinal movement of the piston rod (2).
`2. An injection device according to claim 1, wherein the
`drive member (6) is adapted to be connected to the dose
`setting member (1) via a ratchet (13).
`3. An injection device according to claim 1, 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
`setting member (1) is rotated around the piston rod (2), the
`torsion spring (12) is strained.
`4. An injection device according to claim 3, wherein the
`torsion spring (12) is a helical spring which extends coaxially
`with the piston rod (2).
`5. An injection device according to claim 1, further com(cid:173)
`prising a locking member ( 4) adapted to fixate the piston rod
`(2) in such a way that no relative rotation between of the
`piston rod (2) and the housing (5) is possible when the locking
`member ( 4) is in its locking position.
`6. An injection device according to claim 5, further com(cid:173)
`prising a release button adapted to release the locking mem(cid:173)
`ber ( 4) from its locking position.
`7. An injection device according to claim 6, wherein the
`release button is positioned in the distal half of the length of
`the injection device.
`8. An injection device according to claim 1, further com(cid:173)
`prising a stopping member for defining an outer position of
`the dose indicator barrel (9), the outer position of the dose
`indicator barrel (9) corresponding to a maximum obtainable
`dose.
`9. An injection device according to claim 1, wherein the
`dose the dose indicator barrel rotates to a zero position during 55
`ejection of a dose.
`10. An injection device according to claim 1, further com(cid:173)
`prising a release button located on the device that when
`pressed causes the spring to drive a dose from the injection
`device while simultaneously the dose indicator barrel rotates 60
`towards a zero position and wherein upon completion of the
`dose the indicator barrel is at the zero position and the device
`can then be reset to inject a new dose and where if the new
`dose can be reduced by dialing down the dose setting mecha(cid:173)
`nism without expelling medication from the ejection device 65
`and wherein the new reduced dose can be ejected by pressing
`the release button.
`
`8
`11. An injection device comprising
`a torsion spring (12) operatively connected to a dose setting
`member (1), the dose setting member (1) being adapted
`to set a dose to be ejected from the injection device, and
`a rotatably mounted display member adapted to display the
`dose to be ejected from the injection device in accor(cid:173)
`dance with a setting of the dose setting member (1),