Case 1:22-cv-00023-JPB Document 2-15 Filed 03/18/22 Page 1 of 24 PageID #: 384
`
`
`
`
`
`Exhibit O
`
`
`
`
`

`

`Case 1:22-cv-00023-JPB Document 2-15 Filed 03/18/22 Page 2 of 24 PageID #: 385
`IIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIII
`US010357616B2
`
`(12) United States Patent
`Moiler et al.
`
`(10) Patent No.:
`(4s) Date of Patent:
`
`US 1053575616 B2
`Jnl. 23, 2019
`
`(54)
`
`INJECTION DEVICE WITH AN END OF
`DOSE FEEDBACK MECHAsHSM
`
`(71) Applicant. Novo Nordisk A/S, Bagsvacrd (DK)
`
`(72)
`
`Inventors Claus Schmidt kloaer„ ltredensborg
`(DK), Bo Radmer. Iiilleroed (DK):
`Lars Ulrik Nielsen, Virum (DK);
`('hristian Peter Enggaard, Vejby (DK)
`
`(73) Assignee
`
`ssovo ssordisk A/S, iiagsvaerd (l)K)
`
`"
`
`(
`
`) Notice
`
`Subject to any disclaimer. the term of tlus
`patent is extended or adjusted under 35
`U S C 154(b) by 0 days
`
`(21) Appl. No: 15/815,976
`
`(22)
`
`Filed:
`
`Nov. 17, 2017
`
`(65)
`
`Prior Publication Data
`US 2018/0071459 Ai
`Mar. 15, 2018
`Related U.S. Application Data
`(63) Continuation of application No. 15/241.566. filed on
`Aug 19, 2016. nov Pat. No. 9,861,757. which is a
`(Continued)
`
`(30)
`
`Foreign Application Priority Data
`
`.Ian 25, 2005
`
`(I:P)
`
`05075187
`
`(51)
`
`Int. CL
`A61M 5/20
`(200(i 01)
`A61M 5/24
`(200(i 01)
`(2006.01)
`AG1M 5/315
`(52) U.S. CI.
`('P('.... AGIM5/3157 (2013 01); AG/M5/Za
`(2013.01): riGlM st24 (2013.01); /161M
`5/3155 (2013.01),
`
`(Couiuiucd)
`(58) Field of Classification Search
`CPC ....... A61M S/31S7: A61M 5/20, A61M S/24,
`A6IM st3155; A61M 5/3153S,
`(Continued)
`
`(s()
`
`Refcrcnces Cited
`
`IJ 8 PAI'IIN1 IX)('IJMIINT)
`
`4,592,745 4
`5,114,406 A
`
`6 i9fi6 kcx ct sl
`5 1992 Gab+el et al
`(Continued)
`
`I'Okltl(iN PAI I:N'I D(X'I )MIJN IS
`
`l)E
`EP
`
`ii i999
`I9tiiui4ii9 Ai
`5943S7 Al
`4t 1994
`(Continued)
`
`OTHER PUBLICATIONS
`
`English Abstract of kt.ZZIZZ54 I rcm Espaccnct
`English Absiract of St.15283 io From Fspacenet
`
`Primtiri Extii«incr
`Laurcn P Farrar
`(74) Att«racy, Agent, «r I'irm Wesley Nicolas
`
`ABSTRACT
`(5 /)
`An uiiiwtion device with a ilosc delivcnug mechanism bcuig
`adapted to provide a non-visual, e.g. audible and/or tactile,
`fi:cdback signal when a sct ilosc has been at least substan-
`tially injected A first and a second part of the injection
`device arc adapted to perfonu a rclauvc rotatioiml move-
`I'he relative mtational
`ment with respect
`to each other.
`movement causes at least uvo parts of the injection device to
`abut or engage, and this abutment or engagentent causes the
`non-visual feedback signal to be enemted. A very distinct
`and prccisc fi:ixlback is provided as comparix! to prior art
`axial solutions because the generation of the feedback signal
`is uutiatcd by thc rclativc rotational movmncnt.
`Iteedback signal may be generated by a change in a rota-
`tional velocity of ai least one part, c g. by changing the pitch
`of a threaded portion or by en aging a non-rotating part and
`a rotatut part. thereby causing the non-mtating part to start
`rotating May alternatively be generated by building up and
`releasing a tension.
`'I'he injection device is suitable for «sleeting insulin
`
`9 Claims, 14 Drawing Sheets
`
`

`

`Case 1:22-cv-00023-JPB Document 2-15 Filed 03/18/22 Page 3 of 24 PageID #: 386
`
`US 10,357,616 B2
`Page 2
`
`Related U.S..Application 1)ata
`I I/813289, filed as
`continuation of application No.
`PCT/EPZOOG/00048&i on Jan 20,
`application No
`2006, ness Pat. No 9,457,154.
`
`(60)
`
`Provistorml applica(ion No. 60(647,491. Iilm! on Jan.
`27. 2005
`
`(52) U.S. CI.&'P('. A6/I 5/3/535 (2013 01): A 6 I M 5/3/55/
`(2013 01): AG/M 5/3/56/ (2013 01); AG/rV
`5/3/585 (2013.01); rI6/r)f 2205/58/ (2013.01),
`AG/r)f 2205/582 (2013.01)
`(58) Field of Classification Search
`CPC ........ A/ilM 5/31551; A61M 5/31561; A61M
`5/31585; A61 M 2205/581; A61M
`2205/582
`Sum applicanon Iilc for compic(e search lnsiory.
`
`(56)
`
`References Cited
`
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`6,004,29i
`6,221,046 Bl
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`9.861,757 D2 s
`2004/0210199 Al
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`12 199'I
`4 2001
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`7 2007
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`9 iOI I
`I I(2012
`102016
`li2018
`10(2004
`
`Poulscn ct al
`Stecnfr:Idt-.lenten ct sl
`Bill coughs ct sl
`Jensen et al
`Klitmose et al
`Weber
`M oil ei
`Ku ch ho fei e ( el
`Klitmosc et sl
`Mlollcr
`Mlollcr
`h(oil ei
`h(oil ei
`hf oil ei
`Mlollcr
`Moiler
`Atteibury et al
`
`A61 M ir20
`AGIM 5(20
`
`I 'Oltl (I(IN PA I I:N'I D(X'I )MEN IS
`
`BP
`JP
`JP
`RL
`SI I
`WO
`WO
`9/30
`
`688571 Al
`2002-403116 A
`2002-513647 A
`2212254
`1528330 A"
`9847688
`99(46805 Al
`2004007002 A I
`
`12 I'i9i
`Ii2002
`i,200 I
`9 2003
`12i(989
`12,r(998
`ll 1999
`I 2004
`
`cited by examiner
`
`U.S. PATENT DOCUMENTS
`1995 Hmns.... A6IM 5 31511
`3 1996 Ssk
`12i1996 Chmoch
`
`i.391,157 A "'
`
`i.i01,670 A
`S.s82,598 A
`
`&r04 208
`
`

`

`Case 1:22-cv-00023-JPB Document 2-15 Filed 03/18/22 Page 4 of 24 PageID #: 387
`
`U.S. Patent
`
`Jul. 23,2019
`
`Sheet 1 of 14
`
`US 10,357,616 B2
`
`FIG. 1
`
`

`

`Case 1:22-cv-00023-JPB Document 2-15 Filed 03/18/22 Page 5 of 24 PageID #: 388
`
`U.S. Patent
`
`Jul. 23,2019
`
`Sheet 2 of 14
`
`US 10,357,616 B2
`
`FIG. 2
`
`

`

`Case 1:22-cv-00023-JPB Document 2-15 Filed 03/18/22 Page 6 of 24 PageID #: 389
`
`U.S. Patent
`
`Jul. 23,2019
`
`Sheet 3 of 14
`
`US 10,357,616 B2
`
`FIG. 3
`
`FIG. 5
`
`

`

`Case 1:22-cv-00023-JPB Document 2-15 Filed 03/18/22 Page 7 of 24 PageID #: 390
`
`U.S. Patent
`
`Jul. 23,2019
`
`Sheet 4 of 14
`
`US 10,357,616 B2
`
`FIG. 4
`
`

`

`Case 1:22-cv-00023-JPB Document 2-15 Filed 03/18/22 Page 8 of 24 PageID #: 391
`
`U.S. Patent
`
`Jul. 23,2019
`
`Sheet 5 of 14
`
`US 10,357,616 B2
`
`15
`
`FIG. 6
`
`

`

`Case 1:22-cv-00023-JPB Document 2-15 Filed 03/18/22 Page 9 of 24 PageID #: 392
`
`U.S... Patent
`
`Jul. 23,2019
`
`Sheet 6 of 14
`
`US 10,357,616 B2
`
`10
`
`FIG. 7
`
`

`

`Case 1:22-cv-00023-JPB Document 2-15 Filed 03/18/22 Page 10 of 24 PageID #: 393
`
`U.S. Patent
`
`Jul. 23,2019
`
`Sheet 7 of 14
`
`US 10,357,616 B2
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`10
`
`FIG. 8
`
`14
`
`

`

`Case 1:22-cv-00023-JPB Document 2-15 Filed 03/18/22 Page 11 of 24 PageID #: 394
`
`U.S. Patent
`
`Jul. 23, 2019
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`Sheet 8 of 14
`
`US 10,357,616 B2
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`24
`
`FIG. 9
`
`

`

`Case 1:22-cv-00023-JPB Document 2-15 Filed 03/18/22 Page 12 of 24 PageID #: 395
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`U.S. Patent
`
`Sheet 9 of 14
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`US 10,357,616 B2
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`17
`
`FIG. 10
`
`

`

`Case 1:22-cv-00023-JPB Document 2-15 Filed 03/18/22 Page 13 of 24 PageID #: 396
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`U.S. Patent
`
`Jul. 23,2019
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`Sheet 10 of 14
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`US 10,357,616 B2
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`14
`
`FIG. 11
`
`

`

`Case 1:22-cv-00023-JPB Document 2-15 Filed 03/18/22 Page 14 of 24 PageID #: 397
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`U.S. Patent
`
`Jul. 23,2019
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`Sheet 11 of 14
`
`US 10,357,616 B2
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`27
`
`FIG. 12
`
`

`

`Case 1:22-cv-00023-JPB Document 2-15 Filed 03/18/22 Page 15 of 24 PageID #: 398
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`U.S. Patent
`
`Jul. 23,2019
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`Sheet 12 of 14
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`US 10,357,616 B2
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`18
`
`FIG. 13
`
`

`

`Case 1:22-cv-00023-JPB Document 2-15 Filed 03/18/22 Page 16 of 24 PageID #: 399
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`U.S. Patent
`
`Jul. 23,2019
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`Sheet 13 of 14
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`US 10,357,616 B2
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`18
`
`FIG. 14
`
`

`

`Case 1:22-cv-00023-JPB Document 2-15 Filed 03/18/22 Page 17 of 24 PageID #: 400
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`U.S. Patent
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`Jul. 23,2019
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`Sheet 14 of 14
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`US 10,357,616 B2
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`18
`
`FIG. 15
`
`

`

`Case 1:22-cv-00023-JPB Document 2-15 Filed 03/18/22 Page 18 of 24 PageID #: 401
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`US 10,357
`
`,616 B2
`
`1
`INJECTION DEVICE WITH AN END OF
`DOSE FEEDBACK MECHANISM
`
`('RO)S-Rl ilil igi IN( E I'0 Rl!I,AI I ]I )
`APPLICATIONS
`
`line applicauon is a continuation of application Scr. No.
`15,'241.566. filed Aug 19, 201(i, which is a contimiation of
`application Ser No 11/813S89, filed.jul 9, 2008 (issued as
`U.S. Pat. No. 9,457,154), which is a 35 U.S.C,
`ss 371
`national stage application of International Patent Applica-
`tion PCT/EP2006/000486 /pubhshcd as WO 2006/079481),
`Iiled Jsn. 20, 2006. wluch clmmed puonty of European
`]i]cd Jsn. 25, 2005.
`Patent Apphcauon 05075187.4,
`tlus
`application further claims priority under 35 IJ S C. S5 119 of is
`U.S. Provisional Applicatiim (20/(247,491,
`tiled Jan. 27,
`the contents of which are incorporated herein by
`2005:
`reference.
`
`11EI,I) Oli '111ii iNVEN'I'ION
`
`2C
`
`The present invention relates to an apparatus for dehver-
`ing liquid drugs to a manunal. preferably a lnunan being,
`prcfi:rably ui a subcutaneous manner. Morc particularly, thc
`invmition re]a]ca to an uijcction device whwh is
`prcscnt
`capable of providing a non-visual feedback signal to a user
`indicating that a set dose has been injected by the injection
`device.
`
`BACK(rROUNI) Oli Jl II I INVI',N'I'ION
`
`11)
`
`In the present disclosure reference is mainly made to the
`treatment of diabetes by injection of insulin. However, tlus
`is merely an exemplary use of the present invention. Thus,
`thc prcscnt uivcntion may bc used liir uifccuon of any other is
`suitable kind oi'rug. c g. growth hormone.
`Injection devices. e g. in the form of uijcction pens, are
`themselves
`niainly nmde for users who have to inject
`frequently, e.g people having insulin-dependent diabetes or
`needing treatment by grov th horn]ones. A number of sc
`requirements are set to such injection devices. The setting of
`dose must bc easy and unambi uous and it nuist be misy
`to rend the sct dose Furthcrmorc, it must be possible, with
`miiumum of trouble, to cancel or clmngc a wrongly sct
`dose. I'inally. when the dose is injected the dose setting
`mechanisni must return to zero. This is very important since
`thereby
`the set dose is actually injected.
`it ensures that
`allowing the user to keep tracl of which dose is injected
`Many uijcction devices work with a tlueadcd piston rod
`winch coopcratcs with a nut, thc nut and jhc piston being
`capable oi'rotaung rclativcly to each other. Thc dose settuig
`niay be obtained by dialing the nut away from a stop to
`which it is returned during injection by pressing the piston
`rod forward. either manually or by means of a mechanically
`biased mechanism, such as a spring. until the nut member s.
`sbum the stop. In other in]ection devices one of the elemmits,
`jhe nut or thc piston rod, is kept inru1atablc wlule thc other
`onc is allow tx] to rotate a sct an Ic depcnduig on the sct
`dose, whereby the piston rod is dialed a distance in a ti&rsvard
`direction thniugh the nut nieniber
`In such prior art in]ection devices a dose is normally set
`by dialing a dose setting member. Snd the set dose is injected
`by puslung an us]ection button. In elongates] pcn shaped
`iii]cctloii
`devices ihe dose ac]ting member and the uijection button ss
`normally form a single member. When the injection button
`is pushed the set dose is expelled. I lowever„ the anxiunt of
`
`sc
`
`o
`
`drug expel]cd is olllv ixplsl to tile scj dose lf tile ill]cctioii
`button has been pushed as far as possible, the dose setting
`member thereby havuig burnt brought back to zero. In order
`to ensure that the correct dose has actually been injected, the
`user there]ore has to visually uispect thc position of thc dose
`settiag member during the injection 'I'lus is disadvantageous
`because the injection in some cases i]ill take place in a part
`of the body ivhere visual inspection during the injection is
`very ditficult or even impossible. Furthermore. in case the
`user is visually impaired it may bc ihilicult for thc user to
`visually inspect the dose settin member during or after the
`in]ec1ion. regardless oi where on 1hc body the injection is
`is not uncommon for people having
`performed Since it
`duibctcs to bc visually impmrcd, this is an unportant aspect.
`It is therefore desirable to provide a feedback signal to the
`user indicating that the set dose has been injected,
`the
`feedback signal being of a kind ivhich niakes it unnecessary
`for the user to visually inspect whether or not the set dose is
`iiiJcc1cd.
`Some prior art injection devices have a mechanism wlfich
`infiirms thc user that a duse is being uijcctcd by producuig
`an audible 'click* for each dose unit heing injected I low-
`cvcr, suicc thcsc clmks appear duung thc entire in]ection
`they do not provide a feedback signal indicating that the set
`dose has bema injectixj, mid the problem indicated above is
`therefore not solved by these mjection devices. Prior art
`in]ection devices of this type are„e.g.„described in U.S. Pat.
`No 4 592 745 EP 0 688 571 and I JS 2004/0210199
`In WO 98/57688 an injection device is disclosed which
`thc aboi c menuoned problem. Thus, WO
`addrcsscs
`98/57688 discloses an injection device having a dose setting
`dcvicc A dose is ac]by dmling a dose scuing mmnbcr Apart
`from setting a dose the dialing action causes an injection
`button to bc moves] from a position w herc it abuts a hmisuig
`of the injection device to a position where it pnitrudes from
`the housing. The set dose is subsequently delivered by
`pushin the injection button back into abutnient with the
`housii1
`In onc cmbodimcnt a lock is acuvated when thc in]ection
`button reaches the housing„and the activation of the lock
`produces an midiblc chck uidicating that tlm ui]ection bution
`is in abutment with thc housing and 1hcreby that 1hc set dose
`has been delivered I)urinn the injection, including the final
`part v hen the lock is activated. the injection button is llliivcd
`linearly. The linear distance travelled by the injection button
`dunng the last few doses is relatively short It may therefore
`bc dillicult to dctcrnnnc accurately from thc midiblc click
`produced by 1he lock w bc]her or not and when tlm sei duse
`has bccn dclivcrcd.
`EP 0 594 357 discloses another injection device which
`addresses the above mentioned problem. 'I hus. I SP 0 594 357
`discloses an injection device having a top section with
`resilient legs depending perpendicularly from the top sec-
`tion. The outcr surface of thc rcsilimit legs has a ridge wluch
`rests on a lcdgc uisidc of thc dose knob. Thc dose knob may
`have an elongated section which Iits into a cyluiducal shwvc
`such that v;hen the dose knob is pushed into the sleeve. at the
`end of mjection. the top portion of the sleeve touches end of
`the le of the resilient legs displacing the ndge from the
`ledge and causing a snapping noise. As it is the case with the
`injection device dcscfibcd ui WO 98/57688, the dose knob
`is moved linearly dunng in]em]ion. also during the Iinal part
`of thc uijection when jhc rcsihcnt legs are displaced from the
`ridge causing the snapping noise I'herefore the shortcom-
`ings described above are also applicable here
`
`

`

`Case 1:22-cv-00023-JPB Document 2-15 Filed 03/18/22 Page 19 of 24 PageID #: 402
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`US 10,357
`
`,616 B2
`
`3
`SUMISLARY OF THE INVENTION
`
`completely injcclcd. In;my elcnt Ihc user can regard thc
`perception of the feedback si nal as an indication that the set
`dose has been delivered, and the user nlay therefore react
`correspondingly, e g. by removing a pressure applied manu-
`ally to an injection button.
`Since the non-visual feedback signal is provided only at
`lhc cnd of 111]ection ol s scl dose Ihc usi 1 vvlll kllow disnncdv
`that when Ihc fi:edback signal is received thc sel dose has
`been fully injected I'his is an advantage conlpared to prior
`art mjection devices ivhere a click for each injected dose unit
`is produced. In this case the user would have to count the
`number of clicks produced and compare this to the number
`of set dose units in order to tell exactly when the set dose has
`bixu fully in]ox]ed.
`A lira] part and a sixond part ol'hc in]ection device arc
`adapted to perform a relative rotational movenient
`ivith
`respect to each other during injection of a dose 'Ibis may,
`e g, be the housing and the piston rod. or it may be a
`separate member and any other part of the injection device,
`e g. the housing and/or the piston rod, the sole purpose of the
`separate member bcmg Io gencratc thc nou-vwual fixdback
`signal Tlucc or morc parts of the in]ection device may
`perform nnitual rotational movements during injection of a
`dose.
`liurtherinore, the relative rotational movenlent may be
`perfomled all tluough the injection of a dose or it may be
`perfomled during only part of the Injection. Tints,
`the
`rclalivc rotational moi amen] may bc slarnxl or stopped al
`thc cnd of in]ox]ion ol'a scl dose as dclined above, ul wluch
`case tins starting or stopping may advantageously cmise the
`non-visual feedback sigttal to be generated
`'I'he relative rotational movement causes at least Iwo parts
`of the uljection device to abut or engage, and tlds abutment
`or engagement causes the non-visual feedback signal to be
`gcneratcd. One or both of lhc parts which abut or engage
`may bc Ihc first imd.'or second parts, i.c. the parts perfonnulg
`the rclalivc rotational movcmcnt. Alternatively, one or bo]h
`of the parts which abut or enga e may be other parts of the
`in]ection device This will be described in further details
`below.
`that the relative rotational movement
`Due to the fact
`initiates thc generation of lhc non-wsual fi:cdback signal it
`the movemmll gmlcrating llm uon-visual
`is ensured thol
`fccdback signal is much longer than a correspoudulg move-
`ment in an injection device where the feedback signal is
`generated by a linear movement of one or more parts
`Thereby the generated signal will be nuich more precise and
`distinct. and a far more accurate feedback si nal has thereby
`bixu provided. Tlus is very advantageous because lt makes
`tl much caster lor lhe person lo asccrtaul tlrst lhe cxpccled
`and dcslrcd dose has actually been in]ixlcd
`I'he non-visual feedback sianal nlay comprise an audible
`and/or a tactile signal
`In this case the person using the
`in]ection device v, ill be able to hear and/or feel that the set
`dose has been injected. Alternatively or additionally. the
`nou-visual fccdback signal may comprise any other suitable
`kuid of signal wluch csn be perceived by ollmr senses thun
`sigh]. Furthermore, lhc non-visual fi:cdback signal may bc
`followed by a visual sig/ta], e.g a scale dnuu showing a
`'semk a lamp or a diode which is turned on or off or starts
`simultaneously with the generation of the non-
`ilashln
`visual feedback signal. Thereby the user may. in addition to
`the non-visual fcix]back signal, use this visual fixdback
`signal to further cnsurc that the sct dose has actually beml
`hl]CCICd.
`In one embodiment of the present invention the abutmeot
`or engagement is caused by a change in a rotational velocity
`
`Io
`
`I
`
`It is, tlnis. an object of the present invention to provide an
`injection device being capable of precisely and in a non-
`visual nunmer indicatin to a user when a set dose has been
`injected.
`Ii is a further ob]ccl of Ihe prcscnl ulvcnlion lo provide an
`in]ixuon dci ice being capable ol'non-visually indicating to
`a user ivhen a set dose has been injected. the indication being
`delivered to the user in a very distinct manner.
`It is an even further object of the present invention to
`provide a dose dehverin mechanism for an injecrion
`the dose delivering mechanism beiltg capable of
`device,
`precisely and in a uon-visual manner indicating Io a user
`when a sel dose bas bccn in]ected.
`Accordin to the present invention the above and other
`objects are fidtilled by pmvidulg an injection device conl-
`PI1alng,'
`hollsulg.
`a dose setting member being opemsble to set a desired dose lo
`Io bi: 111]CCli:il,
`a plsion rod bmug adapted to coopcmtc v,ilh a piston so
`as to cause a set dose to be injected from an ampoule,
`and
`a dose delivering nlechanism beino adapted to operate the
`piston rod in such a way that a set dose is injected. the
`dose delivering mechanism further being adapted to
`provide a non-visual fi:cdback signal lo a user only al
`thc end of uljcctiou of a set dose, v;hcrem Iirsl and
`second parts of the injection device are adapted to Io
`perform a relative mtational movement with respect to
`each other dunng injection of a dose, and wherein said
`reLstive rotational movement causes at least two parts
`of the injection device to abut or engage, said abuunent
`or cngagcment causing thc non-visual feedback sigilal ]i
`Io bc gcnerstcd.
`lite uljeclion device of Ihe present ulvenlion is very
`suitable for use by persons which have to frequently inject
`themselves. e.g persons having insulin-dependent diabetes
`or needing treatment by growth hormones. The desired dose so
`being set by means of the dose setting member is. ]luis, a
`duse of a spccilic drug wluch Ihc person ul question needs
`lo in] ix I st thai specilic poult ul tune. 111e dcsircd dose may
`bc s lixed dose which the person needs to mject c mh time
`an injection is performed, or it may be a varying amount. e g.
`varyina according to the time of day andior one or nmre
`parameters wluch may be measured or chosen prior to
`setting the dose ie.g. blood glucose (BO) level. contenrs of
`a meal, clc ).
`Thc piston rod is preferably adaplcx] to push a piston uilo
`an mnpoulc. Ihcrcby causing the sci dose lo bc ul]cclcd. Tlus
`nlay be obtained in various ways and is well knov n and well
`described in the art.
`The dose delivering mechanism is adopted to provide a
`to a user only ar the end of ss
`non-visual feedback s]gnai
`in]ox]ion ol'
`sct dose. Thus, thc feedback signal may bc
`gcncraled when thc set dose has been ulfcclcd, c.g. exactly
`when or immediately aficr thc last uiul has been ulfcclixk
`Alternatively, the feedback signal may be generated before
`the complete dose has been delivered. e g when a few units io
`remain to be injected, the remaining units being injected
`while the feedback si nal is sensed by the user. Thus. v.ben
`thc user perceives the fi:edback si nal thc scl dose will have
`bixn dcliverol, and thc user will therefore not bc able to tell
`thc dillercnce bctwccn a fi:edback si nial bourg gmleratcd si
`affer the dose has been completely injected and a feedback
`signal bein generated imnlediately befiire the dose has been
`
`o
`
`

`

`Case 1:22-cv-00023-JPB Document 2-15 Filed 03/18/22 Page 20 of 24 PageID #: 403
`
`US 10,357,616 B2
`
`i
`of al least onc parI of Ihc dose delivcruig mcchiuusm. Tlus
`may, e.g.. be accomplished by allowing a separate member
`to st dri rot el&ng at Ihc end of in] cc l&on of a set duse. Iyp&cally
`in such a way that this men&her mtates during injection of the
`last few units of the scl dose. The rotauon of tins separate
`niember will m turn generate a non-visual feedback signal to
`in th&s case the rotational velocity of tlus
`the user. Thus.
`member relatively to, e g, the housing„chanaes from zero to
`a certain velocity, and this change causes the non-v&sual
`Iimdback s&goal to be gcucratixi, c.. in thc form of a clicking
`sound generated by protruding parts present on the separate
`member moi &ng aganwt au Outcr part of the housuig or an
`outer part of the p&stun rod
`Alu:matiicly or add&tionally,
`Ihc el&ange ui rolalio»al
`velocity niay cause a tact&le feedback signal to be generated.
`It may, e.g.. be possible to feel the rotational movement
`itself, and thereby &t may be possible for the user to detect
`a substantial change (decrease or increase) in the rotatiorml
`I clue&lv&
`the injection device may further
`In one embodiment
`comprise a ratchet opcral&ng Ihc p&alon rod mid ha& ui
`a
`threaded portion being adapted to engage with a part of the
`dose delivenng niechanisni, in which case the change &n a
`
`rotational velocity is generated by a change in the pitch of'hethreaded port&on of the ratchet, said chan e in the pitch
`
`1&1
`
`20
`
`so
`
`Altcmatively, Ihc p&lch mdy either u&crease or decrcasc
`from one non-zero value to another. This has the advantage
`thai lhc migag&ng part is read&ly &noses] back into engage-
`&&lent v'1th fllc fllrcaclcd portion Ivhcn B oc&v close Is to bc sct
`In another embod&ment the dose del&vcnng mcclm&usm
`may con&prise a first dose part and a second dose perl, the
`adapted to rotate relatively to the
`first dose part bein
`housin during injection of a dose and the first dose part
`comprising means for engaging the second dose part at the
`cnd of uijcction of a scx dose, thereby cmisu&g thc a&mond
`dose part to rotate along &vith the first dose pa&t, in which
`case flm non-visual fimdback s&gnal &s generated by thc
`resultmg rotational movenient of the second dose part.
`In flus emboduncnl Ihc rolaiional movcmcnl of thc a&mond
`dose part increases from zero Io a non-zero value at the end
`of in)ection of the set dose. The second dose parr may be
`pmvided ivith teeth, prolmsions. flexible arnis or similar
`means being adapted to be nu&ved a ainst another part of the
`dcv&ce dunng mlanon of Ihc second dose part.
`Ihcrcby
`a soiuid which at
`least partly constitutes the
`produc&n
`nou-v&sual fccdbacl signal.
`I'he second dose part may be positioned between the first
`dose part and the housing In case the second dose part is
`pmvided v;ith teeth, protrusions. flex&ble arms or the like as
`these may advantageously be moved
`described above.
`against a part of the housing when the second dose parr is
`rolaled along w&lh Uie Iirst dose park
`Ihc non-visual
`Altcmatively,
`fcixlbuck ~ &goal may bc
`generated as a result of an abutment between two parts of the
`dose delivering mechmiism performing a relative mtational
`'I'he feedback si nal niay. e.g . be obtained by
`movement
`releasing a tension &vhich has previously been introduced in
`a part of the injection device, the release of the tension bein
`em&sad by Ihc abulmcnt bclwccn the Iwo parts
`Thc lensed part mdy compose a spnug means. such as a
`separate spnng member or al least oue rcs&1&ent portion of al
`least one of the first and second parts perfi&nning the relative
`Iotational lriovcnlcnt. Io c'isc thc spilog nlc;uls Is In thc foiln
`of at least one resilient portion of the part(s) the non-visual
`feedback signal may be generated in the following mmmer.
`First the rcs&bent pomon(s) &s/are bent into a tensed pos&nun.
`At a later lime flus tension is rclcascd. c.g. by rolal&n
`thc
`rcsil&enl porl&on(s) away Irom a part wh&ch holds Ihc rcs&1-
`ient portion(s) in the tensed position. Thereby the resilient
`portion(s) will restore its,'their relaxed position(s), aod this
`movement v,ill generate a clicking sound„ i e. a non-visual
`feedback signal. The resilient portion(s) may be in the fomi
`of spring arm(s). in wluch case a sound may bc gcncralcx]
`duc lo moving air caused by sudden rclcasc of thc Icnscx]
`spruig ann(s). Alternatively, abulmm&1 bclwccn a movuig
`part and a release mechanisni may release the tension of the
`res&lient portion(s)
`The tension may be introduced during dose setting. e.g. by
`a spring member or moving a resilient portion
`tighten&n
`into a tensed posiuon as dcscr&bcx] above. Tlus nmy bc
`obtained by lcltuig Ihe dose scuing mimhanism be conncctod
`to a spruig member. C.g. &n such a way that a spnng is
`tightened when a dose setting member is turned. or in such
`a way that a part being pmvided with a resihent portion is
`mtated along with a dose setting member„ thereby causin
`the resilient part to be moved into a tensed position.
`Altcmativcly, thc Icos&on may be &ntroduccd duruig uijcc-
`t&on of a dose. Tlus may bc obis&ncd in a maruwr very similar
`to what is desvnbed above. However. &n th&s case thc Icnscx]
`part should be operatively connected to the dose delivering
`olcchanisiu
`
`in retuni em&sing a change in a tmsnslational velocity of said
`pari ol'he dose dcl&vcring &ucchanis&u, smd chmigc &n
`lwc1 piirls of thc
`lrdnsldnonill vcloc& IV causulg Bl
`lcdsl
`thereby causing the non-v&sual
`injection device to abut,
`feedback signal to be generated.
`In Ibis embodiment the non-visual feedback signal pref-
`erably comprises a tactile feedbacl signal. Thus. the part of
`the dose delivenng mechanism which is adapted to en age
`with Ihc flucdded port&ou ol
`the ratchet &s prcfi:rably &n 31
`d&rcclly or uid&rimfly contact w &Ih Ihc user dunng &n&ccl&on
`ol'
`thc part may bc, Iorm perl of or be
`dose. Thus,
`operatively connected to an injection button which the user
`presses during in]ect&on 'I'hereby the user v ill be able to feel
`the change in translational velocity.
`The pitch may be changed from a certain value used
`ilu nag lhc n&d&n pBit of lhc h&] cc non I cl zcu&, I.c. flu: fllrciidi'.d
`portion sunply stops at a pos&lion corrcsponduig 10 thc cnd
`of in] ection ol'a sel dose. Iu th&s case ihc user will fi cl a kind
`of 'axial resistance'uring the injection until the ratchet/
`dose delivery part reaches the position where the tlireaded
`portion stops. Then the part will stop rotating and instead
`increase the veloc&ty of a translational (axial) movement
`which is disc pcrfonncd while lhc ralchcl/dc1sc di 1&vc&y pBf1
`travels ihe tlucadcd portion, duc lo thc pilch ol Ihc threaded
`portion. Thc user w&11 bc able to I'ccl
`this increase &n
`translational velocity I 'urlhermore, the translational nlove-
`nient is preferably eventually stopped, e a. due to part of the
`dose delivery mechanism abuttin a stop member. Tlfis stop
`&vill also be very dist&nctly felt by the user, thereby produc-
`ing a non-v&sual fimdback s&gnal, and &I may further produce
`fi:cdback signal
`sound. ui wh&ch case Ihe non-v&sirdl
`conlp&1siv II
`tactile as weil as an audible signal
`In this embodiment the
`two parts of the injection device ivhich are caused to abut
`may advanta eously be a scale drum and a part of the
`housing. the scale dnnn performing a rotational nnd ax&al
`moi ament dclincd by thc tlucadcd port&on.
`A]ternati& cly, thc two parts may bc d dose knub and a
`proximal part ol'lm housuig, the dose knob pcrfomung an ss
`axial movement &vhich follows the axial part of the nlove-
`nient of the scale dnun as described above
`
`10
`
`0
`
`ss
`
`co
`
`

`

`Case 1:22-cv-00023-JPB Document 2-15 Filed 03/18/22 Page 21 of 24 PageID #: 404
`
`US 10,357,616 B2
`
`lhc dose dcltvcring mechanism may bc adapted to bc
`manually operated. e.g. by means of an injection buuon
`winch the user must press mmtually during lhe uttcclton.
`the dose delivering mechanism ntay be
`Alternatively.
`adapted 10 bc operated by means of d mimhatucally biased
`mecharusm, e.. compnsutg at
`least onc spring. Thc
`mecharucally biased nuxhanism may, in tlus case, be biased
`during settin of a dose When the injection i ~ subsequently
`performed this is done by releasing the tension previously
`built up in the mechanically biaced mechanism, and the
`stored energy will then cause the cet dose to be injected. Tlus
`kind of uttccttou dcvtcc docs nol rcquirc d force appitcxf by
`thc user tn order lo tniccl a scl dose.
`
`BRIEF DESCRIPTION OF THE DRAWINCiS
`
`lhc tm cotton will now be further dcscribcd with refer-
`cttct: 10 lhc Bccotllpattvtttg dtttwttlgs Itt witlcil:
`Fl(i
`I shows a cross section thmugh an injection device
`accorditm to a first embodiment of the invention and beiag 20
`in a position cvhere a dose has been set.
`FI(i. 2 shocvs a cross section tlu ough the injection device
`of FI(i. I in a position where a dose has been injected,
`FIG. 3 shows a click Item adapted lo be postnoncd ut thc
`inlcclton dcvicc ol'IGS. 1 and 2,
`lqCi 4 shows a threaded inner part heing adapted to be
`positioned in an injection device according to a second
`embodiment of the invention.
`FIG. 5 shows a top view of an outer part being adapted to
`engage with the inner part nf FICi. 4.
`FIG. 6 ts a cross section along lute A-A in FIG. 5,
`FIGS. 7-10 show parts ol'utlimtton dcvwes accordutg to
`a third. fourth, fifth and sixth embodiment nf the invention,
`respectively. all having a spnng ann and a ivedge structure,
`11 shows part of an injection device according to a tc
`FI(i
`seventh embodiment of the invention having a spring amt
`and a release mechanism.
`FIG. 12 shows mt outer part ol'thc utlcctton device of FIG.
`11 from a dilli:rmtt ungle, tmd
`I 1CSS 13-15 show part of an injection device accordmg to do
`an eiahth embodiment of the Im ention having, a spring arnl,
`,'Il vatlons pitlttts ill tune
`The Figures are schemattc and simplified for charity. and
`they only show details which are essential to the understand-
`Ittg Of lht: IIIVCtutott VVIIIIC OlhCI IICIIBIS ill 0 ICf1 out. Through-
`the description of thc drawutgs Ihe same reference
`out
`munerals v ill be used for identical or corresponding parts.
`
`Clt
`
`DETAILED DESCRIPTION OF THE DRAWIN(iS
`
`0
`
`When in Ihe following terms as 'upper* and 'lower','left'nd'rightk 'horizontal'nd 'vertical'.
`
`'clockwise'nd
`'counter clockwise'r similar reLstive expressinns are used,
`these only refer to the accompanying drawings and not to the
`actual situation of use The chown Fi urea are schematic s.
`It:ptcsctudltotts fot'hich n:dsott lite cotlftgttrBIIOII 01 thc
`dtfli:rmu slruclurcs as well as Ihctr relaltvc dimensions arc
`intcndcxl lo serve illustrative purposes only. In thai conlcxl
`it ntay be convenient to define that the term 'distal end'n
`the accompanying drawings is meant to refer tn the end of to
`the injection device carryin an injection needle. whereas
`the teml 'proximal end's meant to refer to the opposite end
`poutlutg ttway from Ihe utlimnon nemllc.
`FIG. 1 shows a cross section tluuugh an mjeclion device
`1 according to u first mnbodtmcnl of thc utvenlion. At tts sc
`distal end the injection device I is pntvided with a portion
`2 being atkcpted to carry atl injection needle (not showtlb At
`
`its proximal end thc uticcuon device 1 compnscs a com-
`bined dose setting and injection button 3 During dose
`setting the dose settin and injection b