Case 1:22-cv-00023-JPB Document 2-6 Filed 03/18/22 Page 1 of 20 PageID #: 224
`
`
`
`
`
`Exhibit F
`
`
`
`
`
`

`

`Case 1:22-cv-00023-JPB Document 2-6 Filed 03/18/22 Page 2 of 20 PageID #: 225
`IIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIII
`US009108002B2
`
`lI2~ United States Patent
`Markussen
`
`(10) Patent No. :
`(45) Date of Patent:
`
`US 9,108,002 B2
`Aug. 18, 2015
`
`(54) AUTOMATIC INJECTION DEVICE WITH A
`TOP RELEASE MECHANISM
`
`(75)
`
`Inventor:
`
`Tom Hede Markussen, Bagsva:rd(DK)
`
`(73) Assignee: Novo Nordisk A/S, Bagsvaerd (DK)
`( * ) Notice:
`
`the term of this
`Subject to any disclaimer,
`is extended or adjusted under 35
`patent
`U.S.C. 154(b) by 0 days.
`
`(21) Appl. No. : 13/326, 738
`
`(22)
`
`Filed:
`
`Dec. 15, 2011
`
`(65)
`
`Prior Publication Data
`US 2012/0083746 Al
`Apr. 5, 2012
`Related U.S.Application Data
`(63) Continuation of application No. 11/813,435, filed as
`application No. PCT/DK2006/000032
`on Jan. 20,
`2006, now Pat. No. 8,096,978.
`application No. 60/647, 320, filed on Jan.
`
`(60)
`
`Provisional
`26, 2005.
`
`(30)
`
`Foreign Application Priority Data
`
`Jan. 21, 2005
`
`(DK) ...
`
`... 2005 00113
`
`(51)
`
`(2006.01)
`(2006.01)
`(2006.01)
`(2006.01)
`
`Int. Cl.
`A 61/If 5/31
`A 61/If 5/315
`A 61/If 5/20
`A61M 5/24
`(52) U.S. Cl.
`............. A 61/If 5/31525 (2013.01);A 61/If 5/20
`CPC
`(2013.01);A61/If 5/31553 (2013.01);A61M
`5/24 (2013.01);A61M 5/3156 (2013.01);A61M
`5/31583 (2013.01);A61M 5/31593 (2013.01);
`A61M 2005/202 (2013.01)
`
`(58) Field of ClassiTication Search
`CPC .......... A61M5/20; A61M2005/2026; A61M
`2005/2073
`USPC .......... 604/134 —139, 151—153, 187, 207—211
`See application file for complete search history.
`
`. .. 604/117
`
`(56)
`
`References Cited
`
`U.S. PATENT DOCUMENTS
`
`5, 104,380 A
`5,308,340 A
`5,383,865 A
`5,496,293 A
`5,658,259 A
`5,665,071 A
`5,728,074 A
`5,820,602 A
`6,221,046 Bl
`
`4/1992 Holman et al.
`5/1994 Harris
`1/1995 Michel
`3/1996 Huggenberger
`8/1997 Pearson et al.
`9/1997 Wyrick
`3/1998 Castellano et al.
`10/1998 Kovelman et al.
`et al.
`4/2001 Burroughs
`
`(Continued)
`
`FOREIGN PATENT DOCUMENTS
`
`EP
`EP
`
`0293958 Al
`0293958 B
`(Continued)
`
`12/198 8
`12/198 8
`
`Primary Examiner
`Laura Bouchelle
`(74) Attorney, Agent, or Firm
`Wesley Nicolas
`
`ABSTRACT
`
`(57)
`inj ec-
`invention relates to a handheld mechanical
`The present
`tion device by which set doses of a liquid medicament
`can be
`reservoir. The medicament
`is
`from a medical
`injected
`expelled through an injection needle by release of a power
`reservoir being fully or
`in the device,
`reservoir
`the power
`released by actuation of a user operable
`release
`partially
`end of the
`at or near an upper
`member being positioned
`injection device, the upper end being that end of the injection
`device which is opposite the injection needle.
`
`2 Claims, 13 Drawing Sheets
`
`

`

`Case 1:22-cv-00023-JPB Document 2-6 Filed 03/18/22 Page 3 of 20 PageID #: 226
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`US 9,108,002 B2
`Page 2
`
`(56)
`
`References Cited
`
`FOREIGN PATENT DOCUMENTS
`
`U.S. PATENT DOCUMENTS
`
`6,277, 101
`6,364,lt60
`6,3 lt7, 07it
`6,620, 137
`6,663,602
`6,673,049
`6,699,224
`6,743,203
`7,241,27lt
`7,445,613
`7,500,966
`lt, 357, 120
`lt, 6lt4, 969
`2002/0095120
`2004/0019326
`
`BI
`BI
`BI
`B2
`B2
`B2
`B2
`BI
`B2
`B2
`B2
`B2
`B2
`Al
`Al
`
`lt/2001
`4/2002
`5/2002
`9/2003
`12/2003
`I/2004
`3/2004
`6/2004
`7/2007
`I I/200lt
`3/2009
`I/2013
`4/2014
`7/2002
`I/2004
`
`Kirchhofer et al.
`Steck et al.
`Gillespie, HI
`Kirchhofer et al.
`Moiler
`et al.
`Hommann
`Kirchhofer et al.
`Pickhard
`Moiler
`Hommann
`Hommann
`Moiler et al.
`Moiler et al.
`Larsen et al.
`Gilbert et al.
`
`0554996 Al
`EP
`0554996 B
`EP
`0516473 Al
`EP
`EP
`12944Ilt
`JP
`207175lt
`2002-502296 A
`JP
`20910lti
`RU
`2212254
`RU
`152lt330 A3
`SU
`ltlt/Olt725 Al
`WO
`94/13343 Al
`WO
`OI/4Ilt3lt Al
`WO
`0195959
`WO
`03/097133 Al
`WO
`2006/04552lt Al
`WO
`* cited by examiner
`
`lt/1993
`lt/1993
`2/1996
`9/2005
`3/1990
`I/2002
`9/1997
`9/2003
`12/19lt9
`I I/19ltlt
`6/1994
`6/2001
`12/2001
`11/2003
`5/2006
`
`

`

`Case 1:22-cv-00023-JPB Document 2-6 Filed 03/18/22 Page 4 of 20 PageID #: 227
`
`U.S. Patent
`
`Aug. 18, 2015
`
`Sheet 1 of 13
`
`IJS 9,108,002 B2
`
`FIG. 1
`
`

`

`Case 1:22-cv-00023-JPB Document 2-6 Filed 03/18/22 Page 5 of 20 PageID #: 228
`
`U.S. Patent
`
`Aug. 18, 2015
`
`Sheet 2 of 13
`
`US 9,108,002 B2
`
`FIG. 2
`
`

`

`Case 1:22-cv-00023-JPB Document 2-6 Filed 03/18/22 Page 6 of 20 PageID #: 229
`
`U.S. Patent
`
`Aug. 18, 2015
`
`Sheet 3 of 13
`
`US 9,108,002 B2
`
`13
`
`10
`
`14
`6
`
`12
`
`000 000000000
`
`0000000000000
`
`~
`
`D
`
`. ~
`
`j ~
`
`FIG. 3
`
`

`

`Case 1:22-cv-00023-JPB Document 2-6 Filed 03/18/22 Page 7 of 20 PageID #: 230
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`U.S. Patent
`
`Aug. 18, 2015
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`Sheet 4 of 13
`
`US 9,108,002 B2
`
`13
`
`10
`
`16
`17
`
`12
`
`000 000000000
`
`0000000000000
`
`18
`
`FIG. 4
`
`

`

`Case 1:22-cv-00023-JPB Document 2-6 Filed 03/18/22 Page 8 of 20 PageID #: 231
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`U.S. Patent
`
`Aug. 18, 2015
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`Sheet 5 of 13
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`US 9,108,002 B2
`
`17
`
`FIG. 5
`
`

`

`Case 1:22-cv-00023-JPB Document 2-6 Filed 03/18/22 Page 9 of 20 PageID #: 232
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`U.S. Patent
`
`Aug. 18, 2015
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`Sheet 6 of 13
`
`US 9,108,002 B2
`
`20
`
`22
`21
`
`24
`23
`
`19
`
`000 0 00000000000
`
`000 0000000000000
`
`FIG. 6
`
`

`

`Case 1:22-cv-00023-JPB Document 2-6 Filed 03/18/22 Page 10 of 20 PageID #: 233
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`U.S. Patent
`
`Aug. 18, 2015
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`Sheet 7 of 13
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`US 9,108,002 B2
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`20
`
`21
`
`0000000000000
`
`0000000000000
`
`FIG. 7
`
`

`

`Case 1:22-cv-00023-JPB Document 2-6 Filed 03/18/22 Page 11 of 20 PageID #: 234
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`U.S. Patent
`
`Aug. 18, 2015
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`Sheet 8 of 13
`
`US 9,108,002 B2
`
`20
`
`21
`
`00000000000
`
`27
`
`0000000000000
`
`

`

`Case 1:22-cv-00023-JPB Document 2-6 Filed 03/18/22 Page 12 of 20 PageID #: 235
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`U.S. Patent
`
`Aug. 18, 2015
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`Sheet 9 of 13
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`US 9,108,002 B2
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`28
`
`34
`
`Oc
`
`32
`
`33
`
`31
`
`0
`
`FIG. 9
`
`

`

`Case 1:22-cv-00023-JPB Document 2-6 Filed 03/18/22 Page 13 of 20 PageID #: 236
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`U.S. Patent
`
`Aug. 18, 2015
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`Sheet 10 of 13
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`US 9,108,002 B2
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`20
`
`10
`
`39
`
`37
`
`40
`
`38
`
`FIG. 10
`
`

`

`Case 1:22-cv-00023-JPB Document 2-6 Filed 03/18/22 Page 14 of 20 PageID #: 237
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`U.S. Patent
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`Aug. 18, 2015
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`Sheet 11 of 13
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`US 9,108,002 B2
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`40
`
`FIG. 11
`
`

`

`Case 1:22-cv-00023-JPB Document 2-6 Filed 03/18/22 Page 15 of 20 PageID #: 238
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`U.S. Patent
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`Aug. 18, 2015
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`Sheet 12 of 13
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`US 9,108,002 B2
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`40
`
`FIG. 12
`
`

`

`Case 1:22-cv-00023-JPB Document 2-6 Filed 03/18/22 Page 16 of 20 PageID #: 239
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`U.S. Patent
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`Aug. 18, 2015
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`Sheet 13 of 13
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`US 9,108,002 B2
`
`40
`
`

`

`Case 1:22-cv-00023-JPB Document 2-6 Filed 03/18/22 Page 17 of 20 PageID #: 240
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`US 9, 108,002 B2
`
`1
`AUTOMATIC INJECTION DEVICE WITH A
`TOP RELEASE MECHANISM
`
`CROSS-REFERENCE TO RELATED
`APPLICATIONS
`
`This application is a continuation of U.S. patent applica-
`tion Ser. No. 11/813,435 filed Jun. 2, 2008 (U.S. Pat. No.
`8,096,978, issued Jan. 17, 2012) which is a 35 U.S.C. )371
`stage application of International Patent Application
`national
`PCT/DK2006/000032 (published as WO 2006/076921), filed
`Jan. 20, 2006, which claimed priority of Danish Patent Appli-
`cation PA 2005 00113, filed Jan. 21, 2005; this application
`further claims priority under 35 U.S.C. )119of U.S. Provi-
`sional Application 60/647, 320, filed Jan. 26, 2005.
`The present
`invention relates to an automatic and handheld
`injection device where an injection of a set dose
`mechanical
`of medicament
`a release member
`is initiated by actuating
`being arranged at or near the top of the injection device.
`
`BACKGROUND OF THE INVENTION
`
`been dis-
`injection devices have previously
`Automatic
`closed in the patent
`injection devices
`literature. Automatic
`contain some sort of power
`electrical or
`reservoir where
`energy can be accumulated. The accumulated
`mechanical
`energy is easily released by actuating a release mechanism
`energy assists the user in injecting
`whereby the accumulated
`a set dose of medicine and/or assisting needle insertion.
`For example, EP 0 516 473 AI discloses an injection device
`having a needle which, when the device is operated,
`is first
`then liquid is forced out
`caused to project,
`through it, and
`retracted. The needle
`the needle
`is automatically
`finally
`extends forwardly from a capsule that can slide longitudinally
`within a barrel-like body, a relatively weak spring normally
`the capsule and needle retracted. A more power-
`maintaining
`ful spring acts oppositely on a plunger which, when released,
`shoots the capsule forward by acting on the liquid therein, and
`then forces the liquid out through the proj ecting needle. At the
`end of the forward
`are
`stroke
`the plunger
`and capsule
`decoupled and the weak spring returns the exhausted capsule
`and its needle to the retracted position. The spring acting on
`the plunger can be released by a release button positioned on
`the outer surface of the injection device.
`In WO 01/41838 discloses a handheld injection device by
`which set doses of a liquid medicament
`can be injected from
`such as cylinder ampoule, by release of a
`a medical
`reservoir,
`in the device. The power reservoir can either
`power reservoir
`be an electric battery by which a motor can be energized to
`press out a set dose of medicine, or a strained spring main-
`tained in its strained position by a detent which spring when
`released can press out a set dose ofmedicine. When the power
`the liquid medicine will be pressed out
`is released,
`reservoir
`an injection needle
`from the cylinder
`ampoule
`through
`mounted on the cylinder ampoule or on the injection device
`ampoule. The power
`reservoir
`is
`the
`cylinder
`carrying
`released fully or partially by activating a release button,
`such
`located on the housing of the injection
`as an electric switch,
`device and in the distal half of the length of the injection
`third of the
`device. By making at least a part of the distal
`injection device of an ergonomic
`shaped cross section,
`the
`user can grip the injection device as a pencil
`is gripped by a
`thumb, an index finger and a long finger.
`In both EP 0 516 473 Al and WO 01/41838 the release
`are positioned on an outer surface of the injection
`buttons
`devices. In EP 0 516 473 Al the release button is position on
`side of the cylindrical
`in WO
`the outer
`body, whereas
`
`01/41838 the release button is positioned close to the injec-
`tion needle ofthe injection device. However,
`it may be advan-
`tageous to position the release button or mechanism so that
`the injection device can be activated by providing a force to
`region of the injection device
`to a
`the upper
`preferably
`release button or mechanism arranged axially with the injec-
`tion device.
`It is an object of the present
`invention to provide an auto-
`injection device having
`matic and handheld mechanical
`a
`combined release member and dose setting member.
`It is a further object of the present
`invention to provide an
`injection device where
`and handheld mechanical
`automatic
`an injection of a set dose can be initiated using the thumb or
`the index finger of the hand handling the injection device by
`region of the injection
`an axial force to an upper
`providing
`device.
`It is a still further object of the present
`invention to provide
`injection device hav-
`an automatic and handheld mechanical
`to conventional manual
`ing an exterior design very similar
`injection devices.
`
`SUMMARY OF THE INVENTION
`
`The above-mentioned
`objects are complied with by pro-
`in a first aspect, a handheld injection device by which
`viding,
`set doses of a liquid medicament
`can be injected from a
`through an injection needle by release of a
`reservoir
`medical
`in the device,
`reservoir
`reservoir being
`the power
`power
`adapted to be fully or partially released by actuation of a user
`operable release member positioned at or near an upper end of
`end being that end of the
`the injection device,
`the upper
`injection device which is opposite the injection needle,
`the
`power reservoir being adapted to be powered by rotation of a
`rotatably mounted dose setting member.
`The amount of power provided to the power reservoir may
`depend on the angle of rotation of the dose setting member.
`limited rotation of the dose setting member
`Thus, a rather
`small amount energy to the power res-
`provides a relatively
`ervoir, whereas a large rotation of the dose setting member
`large amount of energy to the power
`a relatively
`provides
`reservoir.
`The release member may be positioned less than one fifth
`or one sixth of the length of the injection device from the
`the release member may be axially
`upper end. Alternatively,
`arranged relative to the injection device so that
`the release
`forms a push button like release member on the top
`member
`of the injection device.
`The release member may be operatively
`connected to a
`dose setting member ofthe injection device in that the release
`member may engage the dose setting member via a key/
`keyway connection when the dose setting member
`is in a dose
`setting position. The release member may be released from
`connection with the dose setting member
`the key/keyway
`is in a dose injecting position.
`when the dose setting member
`the handheld injection device has no
`With this arrangement,
`rotating exterior parts or elements.
`The power reservoir may be a resilient member,
`such as a
`torsion spring or a linear spring,
`the resilient member being,
`when released, adapted to press out a set dose of medicine
`through the injection needle. The
`from the medical
`reservoir
`release member may be operatively
`connected to a release
`mechanism adapted to release the resilient member when said
`release member
`is actuated. The release member may have a
`shape which is ergonomic shaped to be activated by a thumb
`or an index finger of the user.
`ampoule com-
`reservoir may be a cylindrical
`The medical
`prising a first and a second end of which the first end is closed
`
`5
`
`10
`
`15
`
`20
`
`25
`
`30
`
`35
`
`40
`
`45
`
`50
`
`55
`
`60
`
`65
`
`

`

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`US 9, 108,002 B2
`
`by a pierceable membrane which may be pierced by a first end
`of the injection needle when this needle is mounted on the
`device. The other end of the injection needle may be sharp so
`as to be able to pierce the skin at
`the position where
`an
`injection is to be made. The second end of the ampoule may
`be closed by a piston which may be forced into the ampoule
`so as to expel medicament
`through the needle.
`injection device may further
`The handheld
`a
`comprise
`drive member being adapted to at least
`rotatably
`arranged
`partly engage with at least part of a drive track of an associ-
`ated piston rod, the drive member being adapted to be posi-
`tioned in a first axial position when the dose setting member
`is in a dose setting position,
`the drive member
`further being
`adapted to be positioned in a second axial position when the
`is in a dose injection position,
`dose setting member
`the drive
`member being adapted to release energy accumulated
`in the
`is in its second axial
`power reservoir when the drive member
`position.
`The drive member may be adapted to rotate the associated
`piston rod upon releasing
`the accumulated
`energy in the
`power reservoir. However,
`in its first axial position,
`the drive
`is prevented from rotating because the drive member
`member
`engages at least part of a housing of the injection device. The
`injection device may further
`a resilient member,
`comprise
`for biasing the drive member
`such as a linear
`in a
`spring,
`direction towards the dose setting member. The linear spring
`operatively connects the drive member and the housing.
`The dose setting member may be adapted to be moved a
`distance along an axial direction of the injection device so as
`to move the drive member between the first and second axial
`positions. The drive member may be adapted to be moved
`from the first to the second axial position by applying a force
`the force being applied along the
`to the dose setting member,
`axial direction of the injection device.
`The injection device may, as already mentioned,
`further
`comprise a push button axially arranged with the dose setting
`the push button being adapted to engage with the
`member,
`dose setting member when the dose setting member
`is in its
`from the dose setting
`dose setting position,
`and disengage
`is in its dose injection
`member when the dose setting member
`position. By disengage is meant
`the push button and the
`that
`dose setting member are mutually rotatable when this disen-
`gaged state is reached. The injection device may further com-
`for axially
`prise a resilient member,
`such as a linear spring,
`biasing the push button in a direction away from the drive
`member.
`injection device may further
`The handheld
`a
`comprise
`adapted to display the
`display member
`rotatably mounted
`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 cor-
`responding to at least one revolution of the display member.
`The display member may comprise a dose indicator barrel
`helical path
`arranged along a substantially
`having numerals
`or in addition,
`on an outer surface thereof. Alternatively
`the
`display member may comprise a counting device having two
`or more display wheels having numerals
`arranged on an outer
`surface thereof.
`injection device may further comprise the
`The handheld
`associated the piston rod,
`the piston rod having a threaded
`outer surface with the drive track arranged in a longitudinal
`direction of the outer surface of the piston rod. The drive
`connected to the dose setting
`member may be operatively
`member via a ratchet.
`The power reservoir may be arranged between the housing
`in such a way that when the dose
`and the dose setting member
`is rotated, energy is accumulated in the power
`setting member
`
`6
`
`10
`
`16
`
`20
`
`26
`
`30
`
`36
`
`40
`
`46
`
`60
`
`66
`
`60
`
`66
`
`reservoir. The power reservoir may comprise a torsion spring
`formed as a helical spring extending coaxially with the asso-
`ciated piston rod.
`It is to be noted that
`the interaction
`between the drive
`the piston rod and the housing may be implemented
`member,
`the piston rod has a threaded outer
`in various ways. Above,
`direc-
`surface and a drive track arranged in the longitudinal
`tion of the rod. A key arranged on the drive member engages
`the drive track ofthe rod and the forward movement ofthe rod
`relative to the housing is caused by the threaded outer portion
`of the rod which meshes with a corresponding
`threaded por-
`tion of the housing. Alternatively,
`the threaded outer surface
`ofthe rod may mesh with a corresponding threaded portion of
`the drive track arranged
`in the
`the drive member whereas
`direction of the rod engages with a key fixedly
`longitudinal
`arranged relative to the housing.
`
`BRIEF DESCRIPTION OF THE INVENTION
`
`in its
`
`invention will now be explained
`The present
`in further
`details with reference to the accompanying
`figures wherein
`FIG. 1 shows an injection device according to the present
`invention where the release button arranged at the top of the
`device is activated by the thumb of the user,
`FIG. 2 shows an injection device according to the present
`invention where the release button arranged at the top of the
`device is activated by the index finger of the user,
`FIG. 3 shows an injection device according to the present
`invention where the release button is arranged
`on the top
`surface of the dose setting member,
`the drive
`and where
`is in its locked position (dial position of dose setting
`member
`member),
`FIG. 4 shows an injection device according to the present
`invention where the release button is arranged
`on the top
`surface of the dose setting member,
`the drive
`and where
`is in its released position (dosing position of dose
`member
`setting member),
`FIG. 5 shows an expanded view of the drive member
`released position,
`FIG. 6 shows an expanded view ofthe release member
`locked position with the dose setting member,
`FIG. 7 shows an expanded view ofthe release member
`released position with the dose setting member,
`FIG. S shows an expanded view of the release member
`released position where the dose setting member
`further
`allowed to rotate,
`FIG. 9 shows one way of implementing
`the release mecha-
`nism for releasing the energized power reservoir,
`FIG. 10 shows another way of implementing
`the release
`mechanism for releasing the energized power reservoir,
`FIG. 11 shows a third way of implementing
`the release
`mechanism for releasing the energized power reservoir,
`FIG. 12 shows a fourth way of implementing
`the release
`mechanism for releasing the energized power reservoir, and
`FIG. 13 shows a fifth way of implementing
`the release
`mechanism for releasing the energized power reservoir.
`While the invention is susceptible to various modifications
`have been
`embodiments
`specific
`and alternative
`forms,
`shown by way of example
`and will be
`in the drawings
`described in detail herein. It should be understood,
`however,
`that the invention is not intended to be limited to the particular
`the invention is to cover all modifi-
`forms disclosed. Rather,
`cations, equivalents,
`falling within the spirit
`and alternatives
`and scope of the invention as defined by the appended claims.
`
`in its
`
`in its
`
`in a
`is
`
`DETAILED DESCRIPTION OF THE INVENTION
`
`FIGS. 1 and 2 show the present
`invention in its most gen-
`eral aspect. In FIG. 1 a handheld injection device 1 is shown.
`
`

`

`Case 1:22-cv-00023-JPB Document 2-6 Filed 03/18/22 Page 19 of 20 PageID #: 242
`
`US 9, 108,002 B2
`
`The injection device has an injection needle 2 fastened to one
`of its ends, whereas
`a release button 3 is arranged
`at
`the
`opposite end of the injection device. When the release button
`3 is actuated by provided a force to it along the axial direction
`of the device energy is released from an internal power res-
`ervoir whereby a set dose of medicine is injected from the
`inj ection device. In FIG. 1 the release button is actuated by the
`thumb 4 of the user, whereas
`in FIG. 2 the release button is
`actuated by the index finger 5 of the user.
`to be injected is contained
`The medicine
`in a medical
`reservoir
`typically formed as a cylindrical
`ampoule.
`The energy released when the release button 3 is mechani-
`cal energy. The power reservoir can be a resilient member,
`such as a torsion spring,
`the resilient member being, when
`released, adapted to press out a set dose of medicine from the
`through the injection needle. The release
`reservoir
`medical
`button is operatively connected to some sort of release mecha-
`nism adapted to release the resilient member when the release
`button is actuated.
`FIG. 3 shows a cross-sectional view of one embodiment of
`invention. The injection device shown in FIG. 3
`the present
`6, a dose setting member 7, a drive
`comprises
`a housing
`member S, a piston rod 9, a torsion spring 10, a biasing spring
`11,a cylindrical ampoule 12 and a release member 13.FIG. 3
`shows the injection device in a state where the dose setting
`member 7 is in its dose setting position.
`A dose is set by rotating the dose setting member 7 a certain
`angle or a certain number ofturns. By rotating the dose setting
`member 7 the torsion spring 10 is strained because the two
`ends of the torsion spring 10 are fixed to the housing 6 and to
`the dose setting member 7, respectively. The dose setting
`member 7 is operatively connected to the drive member 8 via
`the dose
`(not shown). This ratchet prevents
`a ratchet
`that
`setting member 7 returns to its initial position upon straining
`the torsion spring 10. Since the drive member S engages the
`connection or a gear wheel,
`housing 6 via a key/keyway
`the
`drive member S is not allowed to rotate relative to the housing
`6 as long as the dose setting member 7 is in its dose setting
`in FIG. 3. In order to keep the dose
`position as illustrated
`setting member 7 and the drive member S in the dose setting
`the drive member S and the dose setting member 7 is
`position,
`the top end of the injection
`biased in a direction towards
`device. This biasing is provided by a spring element,
`such as
`a linear spring 11, arranged between the drive member S and
`part of the housing 6. Thus,
`to release the drive
`in order
`member S from its engagement with the housing 6, a force
`needs to be provided in order move the dose setting member
`the medicine ampoule 12.
`7 and the drive member S towards
`A miner cavity 14 ensures that this forward movement of the
`dose setting member 7 and the drive member S can be per-
`since the drive member 7 and the piston
`formed. Similarly,
`rod 9 engage via a key connection the drive member S is
`allowed to move axially relative to the piston rod 9.
`The drive member S has been released from its engagement
`with the housing 6 in FIG. 4. In order to achieve this releasing
`indicated by arrow 15, has been provided to the
`a force,
`release member 13 whereby the release member 13, the dose
`member 7 and the drive member S have all been moved a
`the medicine ampoule 12. The force indi-
`distance towards
`cated by arrow 15 would normally be provided by the thumb
`or the index finger of the user.
`As seen in FIG. 4 the engaging region 16 of the housing is
`now separated from the engaging region 17ofthe drive mem-
`ber S. This disengagement
`the strained torsion
`that
`allows
`spring 10 can release its energy to the dose setting member 7.
`The dose setting member 7 and the drive member S are fixedly
`related via the intermediate
`ratchet
`(not shown). Thus, when
`
`5
`
`10
`
`15
`
`20
`
`25
`
`30
`
`35
`
`40
`
`45
`
`50
`
`55
`
`60
`
`65
`
`between engaging regions 16 and 17 has
`a disengagement
`the dose setting member 7 and the drive
`been established,
`the torsion spring 10 reaches an
`member 9 will rotate until
`state. Since the drive member S and the piston rod
`unstrained
`9 is connected via a key connection the rotation of the dose
`setting member 7 and the drive member S will cause the piston
`rod 9 to rotate as well. The piston rod 9 has an outer threaded
`surface which engages with a corresponding threaded portion
`1S of the housing whereby the piston rod 9, upon rotation
`thereof, will perform a translational movement
`along the
`axial direction of the injection device in the direction of the
`ampoule 12.
`the force provided to the release member 13 will
`Thus,
`release accumulated energy in the torsion spring. This energy
`is converted to a translational movement of the piston rod
`the ampoule whereby a set dose of medicine can be
`towards
`injected from the injection device.
`FIG. 5 shows a cut half illustration of the housing 6 of the
`injection device. As seen,
`the drive member S comprises
`an
`region/part 17 formed as gear wheel. Similarly,
`engagement
`the housing 6 comprises a corresponding
`engagement
`region/
`part 16 adapted to receive and engage with the teeth of the
`gear wheel 17.
`FIG. 6 shows another embodiment ofthe present
`invention.
`in FIGS. 3-5 the
`to the embodiment
`In contrast
`shown
`shown in FIG. 6 contains no rotating exterior
`embodiment
`parts or elements. All rotating parts or elements are positioned
`inside the housing 19. FIG. 6 shows a release member 20
`biased
`(formed as a push button) which is mechanically
`towards the end of the injection device by spring element 22.
`The release member 20 and dose setting member 21 are
`as long as the dose setting member 21
`forced into engagement
`is in its dose setting position. The dose setting member 21 is
`the same end of the injection
`biased towards
`mechanically
`device as the release member 20 due to a spring element
`(shown as spring element 11 in FIG. 3) acting on the drive
`(shown as drive member S in FIG. 3) which again
`member
`acts on dose setting member 21. As seen in FIG. 6 the dose
`setting member 21 is biased against a mechanical
`stop 24
`formed in the dose setting member 21 abuts
`where a shoulder
`a part of the housing 19.
`In FIG. 7 an intermediate
`stage is illustrated. Here the
`release member 20 has been pushed an axial distance suK-
`cient to release the release member 20 from the dose setting
`member 21. Note that
`region 25 and 26 are
`the engagement
`disengaged, but since the shoulder ofthe dose setting member
`still abuts the housing part no axial movement of the dose
`setting member 21 has been achieved at this stage. Thus,
`the
`dose setting member 21 is prevented from rotating since the
`drive member
`is still engaging the housing.
`(not shown)
`In FIG. S the dose setting member 21 has been moved an
`axial distance towards the ampoule (not shown) whereby the
`dose setting member
`is allowed to rotate freely causing the
`piston rod 27 push a set dose of medicine out of the ampoule
`the release member 20 and the dose
`(not shown). Note that
`setting member 21 are disengaged in FIG. S. This means that
`the release member 20 is not rotating relative to the housing
`during injection of a set dose. Then the set dose has been
`injected the user removes his thumb or index finger from the
`and the dose
`release member whereby the release member
`return to their respective positions as illus-
`setting member
`trated in FIG. 6, but now with the spring element 23 being in
`a relaxed state.
`In case the user wants to set a new dose, the user rotates the
`the dose setting member
`release member which engages
`whereby the new dose can be set. Injecting the set dose is
`achieved by following the steps illustrated in FIGS. 7 and S.
`
`

`

`Case 1:22-cv-00023-JPB Document 2-6 Filed 03/18/22 Page 20 of 20 PageID #: 243
`
`US 9, 108,002 B2
`
`FIGS. 9-13 show various embodiments of release mecha-
`nisms for releasing the energized power reservoir.
`In FIG. 9 a torsion spring (not shown)
`is energized by
`rotating a ratchet 2S which is operatively
`connected to the
`housing 30 of the injection device when the dose to be
`injected is being set. In the dose setting position the ratchet 2S
`is operatively connected with housing part 31 via ratchet arm
`32. Energy accumulated
`in the torsion spring is released by
`displacing the ratchet 2S axially whereby it is released from
`its connection with housing part 31 in that the ratchet arm 32
`is moved into housing part 33 whereby the piston rod 34 is
`allowed to rotate thereby expelling a set dose of medicament.
`depicted in FIG. 9 a dose indicator
`In the embodiment
`in the direction away from the
`(not shown) moves
`barrel
`(not shown) during setting of a dose. Obviously,
`push-button
`the dose indicator barrel may be adapted to move in the
`opposite direction during setting of a dose, i.e. towards
`the
`push-button.
`depicted in FIG. 10 the ratchet 35 is
`In the embodiment
`only in indirect operation with the housing 39. The drive
`member ofthe embodiment depicted in FIG. 10 is constituted
`one part 36 being adapted to corporate with the
`by three part
`housing 39, another part 3S being adapted to drive the piston
`rod 40 and a flexible member 37 connecting parts 36 and 3S.
`The flexible member 37 is flexible in the axial direction but
`stiff connection between parts 36
`a substantially
`establishes
`and 3S when these parts are rotated relative to each other.
`Thus, the flexible member 37 ensures that parts 36 and 3S are
`not rotatably arranged relative to each other. Thus, when the
`the needle end of the injection
`ratchet 35 is moved towards
`from the housing 39
`device the part 36 is disconnected
`whereby parts 36, 37 and 3S are allowed to rotate thereby
`rotating the piston rod 40. The rotating piston rod 40 causes a
`set dose of medicament
`to be expelled from the injection
`device.
`depicted in FIG. 11 is similar
`The embodiment
`to the
`in FIG. 9 except
`the piston rod is moved
`embodiment
`that
`forward by having guiding tracks arranged
`in the housing
`(instead of in the drive member) and a threaded engagement
`
`10
`
`15
`
`20
`
`25
`
`30
`
`35
`
`(instead of a
`piston rod and the drive member
`between
`between piston rod and housing).
`threaded engagement
`FIGS. 12 and 13 show other release mechanisms
`between
`ratchet, drive member and housing.
`The invention claimed is
`1.A handheld injection device, comprising:
`a rotatable dose setting member
`is rotatable about a
`that
`axis of a housing of the injection device;
`longitudinal
`a power reservoir, comprising a torsion spring for storing
`energy to expel a dose from the injection device;
`a piston rod;
`located at the most proximal portion of
`a release member,
`an end of the device wherein
`the device, opposite
`a
`needle may be mounted;
`injection
`device,
`a rotatably
`the
`further
`comprising
`driver (36, 37, 3S) having at
`arranged multi-component
`least a part (3S) that at least partly engages with at least
`part of a drive track of an associated piston rod, and a
`further part (36) being axially movable into a position
`disconnected
`releasing
`from the housing
`thus
`energy
`the further part (36)
`accumulated in the power reservoir,
`being axially movable by the user applying a force onto
`surface of the release member,
`a generally
`planar
`surface is generally per-
`wherein the generally
`planar
`direction ofthe piston rod in
`to a longitudinal
`pendicular
`the device.
`2. An injection device comprising:
`a housing;
`a drive member;
`a piston rod having a longitudinal
`direction;
`a torsion spring for storing energy to drive a dose from the
`injection device;
`relative rotational motion
`a drive mechanism converting
`into axial movement of the piston rod;
`end of the
`a release button located at the most proximal
`device, opposite an end of the device wherein a needle
`may be mounted,
`the release button having a generally
`to the lon-
`planar surface