Case 1:22-cv-00023-JPB Document 2-9 Filed 03/18/22 Page 1 of 21 PageID #: 278
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`
`Exhibit I
`
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`
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`

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`Case 1:22-cv-00023-JPB Document 2-9 Filed 03/18/22 Page 2 of 21 PageID #: 279
`IIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIII
`US009616180B2
`
`112~ United States Patent
`Markussen
`
`110) Patent No. :
`145) Date of Patent:
`
`US 9,616,180 B2
`*Apr. 11,2017
`
`154) AUTOMATIC INJECTION DEVICE WITH A
`TOP RELEASE MECHANISM
`
`171) Applicant: Novo Nordisk A/S, Bagsva:rd 1DK)
`
`172)
`
`Inventor:
`
`Tom Hede Markussen, Bagsvaerd
`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 0 days.
`to a terminal
`is subject
`This patent
`claimer.
`
`dis-
`
`121) Appl. No. : 14/797, 350
`
`122) Filed:
`
`Jul. 13, 2015
`
`A61/If 5/31553 12013.01); A61/If 5/31585
`12013.01); A6/M 5/24 12013.01); A6/M
`5/3/583 12013.01); A6/M 5/3/593 12013.01);
`A6/M 2005/202 12013.01); A6/M 2005/3/26
`12013.01)
`
`158) Field of Classification Search
`CPC .......... A61M 5/31525; A61M 5/31553; A61M
`5/3156; A61M 5/20; A61M 5/24
`See application file for complete search history.
`
`156)
`
`References Cited
`
`U.S. PATENT DOCUMENTS
`
`5, 104,380 A
`5,308,340 A
`
`4/1992 Holman et al.
`5/1994 Harris
`1Continued)
`
`FOREIGN PATENT DOCUMENTS
`
`165)
`
`Prior Publication Data
`US 2015/0314076 Al
`Nov. 5, 2015
`
`EP
`EP
`
`0293958 Al
`12/1988
`0293958 B
`12/1988
`1Continued)
`
`Related U.S. Application Data
`163) Continuation of application No. 13/326, 738, filed on
`Dec. 15, 2011, now Pat. No. 9, 108,002, which is a
`(Continued)
`
`130)
`
`Foreign Application Priority Data
`
`Jan. 21, 2005
`
`1DK) ...
`
`... 2005 00113
`
`151)
`
`Int. Cl.
`A 61/If 5/31
`A 61/If 5/315
`
`12006.01)
`12006.01)
`1Continued)
`
`152) U.S. Cl.
`CPC .......... A61/If 5/31551 12013.01); A61/If 5/20
`12013.01); A61/If 5/3156 12013.01); A61/If
`5/31525 12013.01); A61/If 5/31528 12013.01);
`
`Pri mary Examiner
`Laura Bouchelle
`174) Attorney, Agent, or Firm
`Wesley Nicolas
`
`(57)
`
`ABSTRACT
`
`The present
`relates
`to a handheld mechanical
`invention
`injection device by which set doses of a liquid medicament
`can be injected from a medical
`reservoir. The medicament
`is
`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
`the upper end being that end of the injec-
`injection device,
`tion device which is opposite the injection needle.
`
`14 Claims, 13 Drawing Sheets
`
`

`

`Case 1:22-cv-00023-JPB Document 2-9 Filed 03/18/22 Page 3 of 21 PageID #: 280
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`US 9,616,180 B2
`Page 2
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`(60)
`
`(51)
`
`(56)
`
`Related U.S. Application Data
`continuation of application No. 11/813,435, filed as
`application No. PCT/DK2006/000032
`on Jan. 20,
`2006, now Pat. No. 8,096,978.
`
`Provisional
`26, 2005.
`
`Int. Cl.
`261M 5/20
`361M 5/24
`
`application No. 60/647, 320, filed on Jan.
`
`(2006.01)
`(2006.01)
`
`References Cited
`
`U.S. PATENT DOCUMENTS
`
`5,383,865
`5,496,293
`5,658,259
`5,665,071
`5,728,074
`5,820,602
`6,221,046
`6,277, 101
`6,364,860
`6,387,078
`6,620, 137
`
`A
`A
`A
`A
`A
`A
`BI
`BI
`BI
`BI
`B2
`
`I/1995
`3/1996
`8/1997
`9/1997
`3/1998
`10/1998
`4/2001
`8/2001
`4/2002
`5/2002
`9/2003
`
`Michel
`Huggenberger
`Pearson et al.
`Wyrick
`Castellano et al.
`Kovelman et al.
`et al.
`Burroughs
`Kirchhofer et al.
`Steck et al.
`Gillespie, HI
`Kirchhofer et al.
`
`6,663,602 B2
`6,673,049 B2
`6,699,224 B2
`6,743,203 Bl
`7,241,278 B2
`7,445,613 B2
`7,500,966 B2
`8,357, 120 B2
`8,684,969 B2
`2002/0095120 Al
`2004/0019326 Al
`
`12/2003
`I/2004
`3/2004
`6/2004
`7/2007
`11/2008
`3/2009
`I/2013
`4/2014
`7/2002
`I/2004
`
`Muller
`et al.
`Hommann
`Kirchhofer et al.
`Pickhard
`Moiler
`Hommann
`Hommann
`Moiler et al.
`Moiler et al.
`Larsen et al.
`Gilbert et al.
`
`FOREIGN PATENT DOCUMENTS
`
`EP
`EP
`EP
`JP
`JP
`RU
`RU
`SU
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`
`0554996 Al
`0554996 B
`0516473 Al
`2071758
`2002-502296 A
`2091087
`2212254
`1528330 A3
`gg/08725 Al
`94/13343 Al
`01/41838 Al
`0195959 Al
`03/097133 Al
`1294418
`2006/045528 Al
`
`8/1993
`8/1993
`2/1996
`3/1990
`I/2002
`9/1997
`9/2003
`12/1989
`11/1988
`6/1994
`6/2001
`12/2001
`11/2003
`9/2005
`5/2006
`
`

`

`Case 1:22-cv-00023-JPB Document 2-9 Filed 03/18/22 Page 4 of 21 PageID #: 281
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`U.S. Patent
`
`Apr. 11,2017
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`Sheet 1 of 13
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`US 9,616,180 B2
`
`FIG. 1
`
`

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`U.S. Patent
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`Apr. 11,2017
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`Sheet 2 of 13
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`US 9,616,180 B2
`
`FIG. 2
`
`

`

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`U.S. Patent
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`Apr. 11,2017
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`Sheet 3 of 13
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`US 9,616,180 B2
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`13
`
`10
`
`14
`6
`
`12
`
`000 000000000
`
`0000000000000
`
`~ D
`
`. ~
`
`FIG. 3
`
`

`

`Case 1:22-cv-00023-JPB Document 2-9 Filed 03/18/22 Page 7 of 21 PageID #: 284
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`U.S. Patent
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`Sheet 4 of 13
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`US 9,616,180 B2
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`13
`
`10
`
`16
`17
`
`12
`
`000 000000000
`
`0000000000000
`
`18
`
`FIG. 4
`
`

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`Case 1:22-cv-00023-JPB Document 2-9 Filed 03/18/22 Page 8 of 21 PageID #: 285
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`U.S. Patent
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`Sheet 5 of 13
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`US 9,616,180 B2
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`17
`
`FIG. 5
`
`

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`Case 1:22-cv-00023-JPB Document 2-9 Filed 03/18/22 Page 9 of 21 PageID #: 286
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`Sheet 6 of 13
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`US 9,616,180 B2
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`20
`
`22
`21
`
`24
`23
`
`19
`
`000 0 00000000000
`
`000 0000000000000
`
`FIG. 6
`
`

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`Case 1:22-cv-00023-JPB Document 2-9 Filed 03/18/22 Page 10 of 21 PageID #: 287
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`Sheet 7 of 13
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`US 9,616,180 B2
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`20
`
`21
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`0000000000000
`
`0000000000000
`
`FIG. 7
`
`

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`Apr. 11,2017
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`Sheet 8 of 13
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`US 9,616,180 B2
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`20
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`21
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`00000000000
`
`27
`
`0000000000000
`
`

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`Case 1:22-cv-00023-JPB Document 2-9 Filed 03/18/22 Page 12 of 21 PageID #: 289
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`Sheet 9 of 13
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`US 9,616,180 B2
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`28
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`34
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`0
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`32
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`31
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`0
`
`FIG. 9
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`

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`Case 1:22-cv-00023-JPB Document 2-9 Filed 03/18/22 Page 13 of 21 PageID #: 290
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`Sheet 10 of 13
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`US 9,616,180 B2
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`10
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`39
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`37
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`40
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`38
`
`FIG. 10
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`

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`Case 1:22-cv-00023-JPB Document 2-9 Filed 03/18/22 Page 14 of 21 PageID #: 291
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`U.S. Patent
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`Sheet 11 of 13
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`US 9,616,180 B2
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`40
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`

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`Sheet 12 of 13
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`US 9,616,180 B2
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`40
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`FIG. 12
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`

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`Sheet 13 of 13
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`US 9,616,180 B2
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`jQ4
`
`40
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`

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`Case 1:22-cv-00023-JPB Document 2-9 Filed 03/18/22 Page 17 of 21 PageID #: 294
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`US 9,616,180 B2
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`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. 13/326, 738, filed Dec. 15, 2011 (Issue Fee
`paid) which is a continuation of U.S. patent application Ser.
`No. 11/813,435 filed Jun. 2, 2008 (Issued) which is a 35
`stage application of International
`U.S.C. )371 national
`Pat-
`PCT/DK2006/000032
`as WO
`ent Application
`(published
`2006/076921), filed Jan. 20, 2006, which claimed priority of
`PA 2005 00113, filed Jan. 21,
`Danish Patent Application
`under 35
`2005;
`claims
`application
`further
`this
`priority
`U.S.C. )119 of U.S. Provisional Application
`60/647, 320,
`filed Jan. 26, 2005.
`and hand-
`The present
`relates to an automatic
`invention
`injection device where an injection of a set
`held mechanical
`dose of medicament
`a release
`initiated
`by actuating
`is
`member 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
`reservoir where electrical or
`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 Al discloses
`an injection
`device having a needle which, when the device is operated,
`then liquid is forced out through it,
`is first caused to project,
`retracted. The needle
`and finally the needle is automatically
`from a capsule that can slide longitudi-
`extends
`forwardly
`a barrel-like
`body, a relatively weak spring
`nally within
`and needle retracted. A
`the capsule
`normally maintaining
`spring acts oppositely on a plunger which,
`more powerful
`shoots the capsule forward by acting on the
`when released,
`and then forces the liquid out
`the
`liquid therein,
`through
`the end of the forward
`needle. At
`stroke the
`projecting
`and the weak spring
`are decoupled
`and capsule
`plunger
`the exhausted capsule and its needle to the retracted
`returns
`position. The spring acting on the plunger can be released by
`surface of the
`a release button
`positioned
`on the outer
`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 medical
`reservoir,
`reservoir can
`in the device. The power
`reservoir
`a power
`either be an electric battery
`can be
`a motor
`by which
`energized to press out a set dose of medicine, or a strained
`in its strained position by a detent which
`spring maintained
`spring when released can press out a set dose of medicine.
`is released,
`the liquid medicine
`reservoir
`When the power
`will be pressed out from the cylinder
`through an
`ampoule
`injection needle mounted on the cylinder ampoule or on the
`injection device carrying the cylinder ampoule. The power
`is released fully or partially by activating a release
`reservoir
`located on the housing of
`such as an electric switch,
`button,
`the injection device and in the distal half of the length of the
`injection device. By making at least a part of the distal
`third
`of the injection device of an ergonomic shaped cross section,
`the user can grip the injection device as a pencil
`is gripped
`an index finger and a long finger.
`by a thumb,
`
`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
`close to the
`is positioned
`button
`injection needle of the injection device. However,
`it may be
`to position the release button or mechanism so
`advantageous
`the injection device can be activated by providing
`a
`that
`force to the upper region of the injection device
`preferably
`to a release button or mechanism arranged axially with the
`injection device.
`It is an object of the present
`to provide
`invention
`an
`injection device having
`automatic 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.
`further object of the present
`It
`to
`is a still
`invention
`injection
`and handheld mechanical
`an automatic
`provide
`to conven-
`an exterior design very similar
`device having
`injection devices.
`tional manual
`
`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
`reservoir
`medical
`in the device,
`reservoir
`reservoir being
`the power
`a power
`adapted to be fully or partially released by actuation of a user
`operable release member positioned at or near an upper end
`of the injection device,
`the upper end being that end of the
`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
`reservoir
`to the power
`may depend on the angle of rotation of the dose setting
`limited rotation of the dose setting
`member. Thus, a rather
`energy to the
`a relatively
`member provides
`small amount
`power reservoir, whereas a large rotation of the dose setting
`a relatively large amount of energy to the
`member provides
`reservoir.
`power
`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,
`the release
`arranged relative to the injection device so that
`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 of the injection device in that
`the
`release member may engage the dose setting member via a
`connection when the dose setting member
`is in
`key/keyway
`a dose setting position. The release member may be released
`connection with the dose setting
`from the key/keyway
`member when the dose setting member
`is in a dose injecting
`position. With this
`injection
`the handheld
`arrangement,
`device has no rotating exterior parts or elements.
`The power reservoir may be a resilient member,
`such as
`a torsion spring or a linear
`the resilient member
`spring,
`adapted to press out a set dose of
`being, when released,
`through the injection
`reservoir
`medicine
`from the medical
`needle. The release member may be operatively
`connected
`to release
`to a release mechanism adapted
`the resilient
`is actuated. The release
`member when said release member
`
`5
`
`10
`
`15
`
`20
`
`25
`
`30
`
`35
`
`40
`
`45
`
`50
`
`55
`
`60
`
`65
`
`

`

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`US 9,616,180 B2
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`shaped to be
`member may have a shape which is ergonomic
`activated by a thumb or an index finger of the user.
`reservoir may be a cylindrical
`The medical
`ampoule
`comprising a first and a second end of which the first end is
`closed by a pierceable membrane which may be pierced by
`a first end of the injection needle when
`is
`this needle
`mounted on the device. The other end of the injection needle
`so as to be able to pierce the skin at
`may be sharp
`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
`so as to expel medicament
`the
`into the ampoule
`through
`needle.
`injection device may further
`The handheld
`a
`comprise
`drive member being adapted to at least
`rotatably
`arranged
`track of an
`least part of a drive
`engage with at
`partly
`associated piston rod, the drive member being adapted to be
`in a first axial position when the dose setting
`positioned
`is in a dose setting position,
`member
`the drive member
`further being adapted to be positioned
`in a second axial
`is in a dose injection
`position when the dose setting member
`the drive member being adapted to release energy
`position,
`in the power reservoir when the drive member
`accumulated
`is in its second axial position.
`The drive member may be adapted to rotate the associated
`piston rod upon releasing
`the accumulated
`energy in the
`in its first axial position,
`power reservoir. However,
`the drive
`is prevented from rotating because the drive mem-
`member
`ber engages at least part of a housing of the injection device.
`The injection device may further comprise a resilient mem-
`for biasing the drive member
`ber, such as a linear spring,
`in
`the dose setting member. The linear
`a direction towards
`spring operatively connects the drive member and the hous-
`ing.
`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
`arranged with the dose
`a push button
`comprise
`axially
`the push button being adapted to engage
`setting member,
`with the dose setting member when the dose setting member
`from the dose
`is in its dose setting position,
`and disengage
`setting member when the dose setting member
`is in its dose
`injection position. By disengage
`the push
`is meant
`that
`button and the dose setting member
`rotatable
`are mutually
`state is reached. The injection device
`when this disengaged
`may further comprise a resilient member,
`such as a linear
`for axially biasing the push button in a direction
`spring,
`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
`over an angle
`being rotatable
`display member
`mounted
`of the display
`least one revolution
`to at
`corresponding
`member. The display member may comprise a dose indicator
`helical
`arranged along a substantially
`barrel having numerals
`path on an outer surface thereof. Alternatively
`or in addition,
`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
`
`6
`
`10
`
`16
`
`20
`
`26
`
`30
`
`36
`
`40
`
`46
`
`60
`
`66
`
`60
`
`66
`
`direction of the outer surface of the piston rod. The drive
`member may be operatively
`connected to the dose setting
`member via a ratchet.
`The power reservoir may be arranged between the hous-
`ing and the dose setting member
`in such a way that when the
`dose setting member
`is rotated, energy is accumulated
`in the
`a tor-
`reservoir. The power
`reservoir may comprise
`power
`coaxially
`sion spring formed as a helical
`spring extending
`with the associated piston rod.
`It is to be noted that
`between the drive
`the interaction
`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 of the rod and the forward movement of the
`rod relative to the housing is caused by the threaded outer
`portion of the rod which meshes with a corresponding
`threaded portion of the housing. Alternatively,
`the threaded
`surface of the rod may mesh with a corresponding
`outer
`portion of the drive member whereas
`threaded
`the drive
`direction of the rod
`track arranged
`in the
`longitudinal
`engages with a key fixedly arranged relative to the housing.
`
`BRIEF DESCRIPTION OF THE INVENTION
`
`in
`
`in
`
`invention will now be explained in further
`The present
`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
`its released position,
`FIG. 6 shows an expanded view of the release member
`its locked position with the dose setting member,
`FIG. 7 shows an expanded view of the release member
`its released position with the dose setting member,
`FIG. S shows an expanded view of the release member
`released position where the dose setting member
`a further
`allowed to rotate,
`one way of implementing
`FIG. 9 shows
`the release
`mechanism 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.
`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
`
`in
`
`in
`is
`
`

`

`Case 1:22-cv-00023-JPB Document 2-9 Filed 03/18/22 Page 19 of 21 PageID #: 296
`
`US 9,616,180 B2
`
`the invention is to cover
`forms disclosed. Rather,
`particular
`all modifications,
`and alternatives
`falling within
`equivalents,
`and scope of the invention
`the spirit
`as defined by the
`claims.
`appended
`
`DETAILED DESCRIPTION OF THE
`INVENTION
`
`FIGS. 1 and 2 show the present
`in its most
`invention
`In FIG. 1 a handheld
`injection device 1 is
`general aspect.
`shown. The injection
`an injection needle
`device has
`2
`fastened to one of its ends, whereas
`a release button 3 is
`arranged at the opposite end of the injection device. When
`a force to it
`the release button 3 is actuated by provided
`along the axial direction of the device energy is released
`a set dose of
`reservoir whereby
`from an internal
`power
`medicine is injected from the injection device. In FIG. 1 the
`4 of the user,
`release button
`is actuated
`by the thumb
`in FIG. 2 the release button is actuated by the index
`whereas
`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
`sort of release
`connected
`to some
`button
`is operatively
`mechanism adapted to release the resilient member when the
`release button is actuated.
`view of one embodiment
`FIG. 3 shows a cross-sectional
`of the present
`invention. The injection device shown in FIG.
`3 comprises
`a housing 6, a dose setting member 7, a drive
`member S, a piston rod 9, a torsion spring 10, a biasing
`ampoule 12 and a release member
`spring 11, a cylindrical
`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 of turns. 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
`6 and to the dose setting member 7, respectively.
`housing
`The dose setting member 7 is operatively
`connected to the
`drive member S via a ratchet
`shown). This ratchet
`(not
`the dose setting member 7 returns
`to its initial
`that
`prevents
`position upon straining the torsion spring 10. Since the drive
`connec-
`member S engages the housing 6 via a key/keyway
`tion or a gear wheel,
`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 position as illustrated in FIG.
`3. In order to keep the dose setting member 7 and the drive
`member S in the dose setting position,
`the drive member S
`and the dose setting member 7 is biased in a direction
`the top end of the injection device. This biasing is
`towards
`spring 11,
`provided by a spring element,
`such as a linear
`S and part of the
`between
`the drive member
`arranged
`housing 6. Thus,
`in order to release the drive member S from
`to be
`6, a force needs
`its engagement with the housing
`provided in order move the dose setting member 7 and the
`the medicine ampoule 12. A miner
`drive member S towards
`this forward movement of the dose
`cavity 14 ensures
`that
`setting member 7 and the drive member S can be performed.
`since the drive member 7 and the piston rod 9
`Similarly,
`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 engage-
`ment with the housing 6 in FIG. 4. In order to achieve this
`
`10
`
`16
`
`20
`
`26
`
`30
`
`36
`
`40
`
`46
`
`60
`
`66
`
`60
`
`66
`
`indicated by arrow 15, has been provided
`releasing a force,
`to the release member 13 whereby the release member 13,
`the dose member 7 and the drive member S have all been
`ampoule 12. The
`moved a distance towards
`the medicine
`force indicated 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 17 of the drive
`member S. This disengagement
`the strained
`allows
`that
`torsion 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).
`between engaging regions 16
`Thus, when a disengagement
`and 17 has been established,
`the dose setting member 7 and
`the torsion spring 10
`the drive member 9 will
`rotate until
`state. Since the drive member S and
`reaches an unstrained
`the piston rod 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
`surface which
`engages with a
`an outer
`threaded
`threaded portion 1S of the housing whereby
`corresponding
`the piston rod 9, upon rotation
`thereof, will perform a
`along the axial direction of the
`translational movement
`injection device in the direction of the ampoule 12.
`the force provided to the release member 13 will
`Thus,
`release
`in the torsion
`spring. This
`accumulated
`energy
`energy is converted to a translational movement of the piston
`rod towards the ampoule whereby a set dose of medicine can
`be 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
`6 comprises
`a corresponding
`the housing
`engagement
`16 adapted to receive and engage with the teeth
`region/part
`of the gear wheel 17.
`FIG. 6 shows another embodiment of the present
`inven-
`shown in FIGS. 3-5 the
`tion. In contrast
`to the embodiment
`shown in FIG. 6 contains no rotating exterior
`embodiment
`parts or elements. All rotating parts or elements
`are posi-
`tioned inside the housing 19.FIG. 6 shows a release member
`20 (formed as a push button) which is mechanically
`biased
`towards the end of the injection device by spring element 22.
`The release member 20 and dose setting member 21 are
`forced into engagement
`as long as the dose setting member
`21 is in its dose setting position. The dose setting member 21
`is mechanically biased towards the same end of the injection
`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
`a shoulder
`where
`abuts a part of the housing 19.
`In FIG. 7 an intermediate
`stage is illustrated. Here the
`20 has been pushed
`release member
`an axial distance
`to release the release member 20 from the dose
`sufficient
`setting member 21. Note that
`region 25 and
`the engagement
`but since the shoulder of the dose setting
`26 are disengaged,
`still abuts the housing part no axial movement of
`member
`the dose setting member 21 has been achieved at this stage.
`the dose setting member 21 is prevented from rotating
`Thus,
`since the drive member
`the
`is still engaging
`(not shown)
`housing.
`In FIG. S the dose setting member 21 has been moved an
`axial distance towards the ampoule (not shown) whereby the
`is allowed to rotate freely causing the
`dose setting member
`piston rod 27 push a set dose of medicine out of the ampoule
`
`

`

`Case 1:22-cv-00023-JPB Document 2-9 Filed 03/18/22 Page 20 of 21 PageID #: 297
`
`US 9,616,180 B2
`
`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
`release member whereby the release member
`and the dose
`as illus-
`return to their respective positions
`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 release member which engages the dose setting member
`whereby the new dose can be set. Injecting the set dose is
`achieved by following the steps illustrated in FIGS. 7 and S.
`FIGS. 9-13 show various embodiments of release mecha-
`for releasing the energized power
`reservoir.
`nisms
`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
`the ratchet 2S axially whereby
`it is released
`by displacing
`from its connection with housing part 31 in that
`the ratchet
`arm 32 is moved into housing part 33 whereby the piston rod
`a set dose of
`34 is allowed
`to rotate thereby
`expelling
`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 of the embodiment
`depicted in FIG. 10 is consti-
`one part 36 being adapted to corporate
`tuted by three part
`with the 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
`stifl' connection
`direction
`a substantially
`but establishes
`between parts 36 and 3S when these parts are rotated relative
`the flexible member 37 ensures
`to each other. Thus,
`that
`parts 36 and 3S are not rotatably arranged relative to each
`other. Thus, when the ratchet 35 is moved towards the needle
`end of the injection device the part 36 is disconnected from
`the housing 39 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
`(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.
`claimed is:
`The invention
`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 torsion spring for storing
`a power reservoir comprising
`energy to expel a dose of medication from the injection
`device,
`a release member axially arranged relative to the injection
`device, wherein
`the release member
`a push
`forms
`button like release member,
`
`10
`
`15
`
`20
`
`25
`
`30
`
`35
`
`40
`
`45
`
`50
`
`55
`
`60
`
`65
`
`device
`injection
`a rotatably
`the
`further
`comprising
`driver (36, 37, 38) having at
`arranged multi-component
`least a part (38) adapted to drive a piston rod, and a
`(36) being axial movable
`into a position
`further part
`disconnected
`from the housing
`releasing
`the energy
`reservoir,
`accumulated
`in the power
`the further part
`(36) being axially movable by the user applying a force
`onto the push button like release member, wherein the
`is located at the most proximal portion
`release member
`of the proximal end of the injection device, opposite an
`end of the device wherein a needle may be mounted.
`2. A handheld
`to claim 1,
`injection device according
`wherein the amount of power provided to the power
`reser-
`voir (10) depends on the angle of rotation of t