Case 1:22-cv-00023-JPB Document 2-8 Filed 03/18/22 Page 1 of 25 PageID #: 253
`
`
`
`
`
`Exhibit H
`
`
`
`
`
`

`

`Case 1:22-cv-00023-JPB Document 2-8 Filed 03/18/22 Page 2 of 25 PageID #: 254
`I 1111111111111111 11111 1111111111 111111111111111 11111 111111111111111 IIII IIII
`US009457154B2
`
`c12) United States Patent
`Moller et al.
`
`(IO) Patent No.:
`(45) Date of Patent:
`
`US 9,457,154 B2
`Oct. 4, 2016
`
`(54)
`
`INJECTION DEVICE WITH AN END OF
`DOSE FEEDBACK MECHANISM
`
`(75)
`
`Inventors: Claus Schmidt Moller, Fredensborg
`(DK); Bo Radmer, Hillerod (DK);
`Lars Ulrik Nielsen, Virum (DK);
`Christian Peter Engaard, Vejby (DK)
`
`(73) Assignee: Novo Nordisk A/S, Bagsvaerd (DK)
`
`( *) Notice:
`
`Subject to any disclaimer, the term ofthis
`patent is extended or adjusted under 35
`U.S.C. 154(b) by 615 days.
`
`5/31593; A61M 5/31535; A61M 2205/582;
`A61M 2205/583; A61M 5/3157; A61M 5/20;
`A61M 5/31561; A61M 5/31585; A51M
`2205/581
`USPC ........ 604/118, 186, 189, 207-211, 232, 246,
`604/260
`See application file for complete search history.
`References Cited
`
`(56)
`
`U.S. PATENT DOCUMENTS
`
`6/1986 Rex et al.
`4,592,745 A
`5,114,406 A * 5/1992 Gabriel .
`
`A61M 5/2033
`604/134
`
`(21) Appl. No.:
`
`11/813,389
`
`(22) PCT Filed:
`
`Jan.20, 2006
`
`(86) PCT No.:
`
`PCT /EP2006/000486
`
`§ 371 (c)(l),
`(2), ( 4) Date:
`
`Jul. 9, 2008
`
`(87) PCT Pub. No.: WO2006/079481
`
`PCT Pub. Date: Aug. 3, 2006
`
`(65)
`
`Prior Publication Data
`
`US 2009/0012479 Al
`
`Jan. 8, 2009
`
`Related U.S. Application Data
`
`(60) Provisional application No. 60/647,491, filed on Jan.
`27, 2005.
`
`(30)
`
`Foreign Application Priority Data
`
`Jan. 25, 2005
`
`(EP) ..................................... 05075187
`
`(51)
`
`Int. Cl.
`A61M 51315
`A61M 5124
`A61M 5120
`(52) U.S. Cl.
`CPC ......... A61M 513157 (2013.01); A61M 513155
`(2013.01); A61M 5/20 (2013.01);
`
`(2006.01)
`(2006.01)
`(2006.01)
`
`(Continued)
`( 58) Field of Classification Search
`CPC .. A61M 5/24; A61M 5/31551; A61M 5/315;
`A61M 5/31541; A61M 5/3155; A61M
`
`(Continued)
`
`FOREIGN PATENT DOCUMENTS
`
`DE
`EP
`
`11/1999
`19819409
`4/1994
`0594357
`(Continued)
`
`OTHER PUBLICATIONS
`
`English Abstract of RU2212254 From Espacenet.
`(Continued)
`
`Primary Examiner - Emily Schmidt
`Assistant Examiner - Lauren M Peng
`(74) Attorney, Agent, or Firm - Wesley Nicholas
`ABSTRACT
`(57)
`An injection device with a dose delivering mechanism being
`adapted to provide a non-visual, e.g. audible and/or tactile,
`feedback signal when a set dose has been at least substan(cid:173)
`tially injected. A first and a second part of the injection
`device are adapted to perform a relative rotational move(cid:173)
`ment with respect to each other. The relative rotational
`movement causes at least two parts of the injection device to
`abut or engage, and this abutment or engagement causes the
`non-visual feedback signal to be generated. A very distinct
`and precise feedback is provided as compared to prior art
`axial solutions because the generation of the feedback signal
`is initiated by the relative rotational movement. Feedback
`signal may be generated by a change in a rotational velocity
`of at least one part, e.g. by changing the pitch of a threaded
`portion or by engaging a non-rotating part and a rotating
`part, thereby causing the non-rotating part to start rotating.
`May alternatively be generated by building up and releasing
`a tension. The injection device is suitable for injecting
`insulin.
`
`17 Claims, 14 Drawing Sheets
`
`\
`
`

`

`Case 1:22-cv-00023-JPB Document 2-8 Filed 03/18/22 Page 3 of 25 PageID #: 255
`
`US 9,457,154 B2
`Page 2
`
`(52) U.S. Cl.
`CPC ........... A61M 5/24 (2013.01); A61M 5/31535
`(2013.01); A61M 5/31551 (2013.01); A61M
`5/31561 (2013.01); A61M 5/31585 (2013.01);
`A61M 2205/581 (2013.01); A61M 2205/582
`(2013.01)
`
`6,796,970 Bl
`7,241,278 B2
`8,202,256 B2
`8,206,361 B2
`8,267,899 B2
`8,333,739 B2
`2004/0210199 Al
`
`9/2004 Klitmose et al.
`7/2007 Moller
`6/2012 Moller
`6/2012 Moller
`9/2012 Moller
`12/2012 Moller
`10/2004 Atterbury et al.
`
`(56)
`
`References Cited
`
`FOREIGN PATENT DOCUMENTS
`
`U.S. PATENT DOCUMENTS
`
`5,391,157 A * 2/1995 Harris ................ A61M 5/31511
`604/208
`5,501,670 A * 3/1996 Sak .................... A61M 5/31511
`604/110
`5,582,598 A * 12/1996 Chanoch ....................... 604/208
`5,957,889 A
`9/1999 Poulsen et al.
`6,004,297 A
`12/1999 Steenfeldt-Jensen
`4/2001 Burroughs et al.
`6,221,046 Bl
`6,248,090 Bl
`6/2001 Jensen et al.
`6,277,098 Bl
`8/2001 Klitrnose et al.
`6,454,743 Bl
`9/2002 Weber
`6,663,602 B2
`12/2003 M0ller
`6,699,224 B2
`3/2004 Kirchhofer et al.
`
`EP
`JP
`JP
`RU
`SU
`WO
`WO
`WO
`
`0688571
`2002-503116 A
`2002-513647
`2212254
`1528330
`WO 98/57688
`WO 99/56805
`WO 2004/007002
`
`12/1995
`1/2002
`5/2002
`9/2003
`12/1989
`12/1998
`11/1999
`1/2004
`
`OTHER PUBLICATIONS
`
`English Abstract of SU1528330 From Espacenet.
`
`* cited by examiner
`
`

`

`Case 1:22-cv-00023-JPB Document 2-8 Filed 03/18/22 Page 4 of 25 PageID #: 256
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`U.S. Patent
`
`Oct. 4, 2016
`
`Sheet 1 of 14
`
`US 9,457,154 B2
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`5
`
`7
`
`6
`
`----------- 1
`
`2
`
`Fig. 1
`
`

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`U.S. Patent
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`Oct. 4, 2016
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`Sheet 2 of 14
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`US 9,457,154 B2
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`5
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`3
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`-------1
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`6
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`4
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`2
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`Fig. 2
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`

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`U.S. Patent
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`Oct. 4, 2016
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`Sheet 3 of 14
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`US 9,457,154 B2
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`9
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`-----5
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`6
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`Fig. 3
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`15
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`Af
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`15
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`14
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`Fig. 5
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`U.S. Patent
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`Oct. 4, 2016
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`Sheet 4 of 14
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`US 9,457,154 B2
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`11
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`10
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`Fig. 4
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`U.S. Patent
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`Sheet 5 of 14
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`US 9,457,154 B2
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`1
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`15
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`Fig. 6
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`Sheet 6 of 14
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`VS 9,457,154 B2
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`10
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`14
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`18
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`Fig. 7
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`Sheet 7 of 14
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`US 9,457,154 B2
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`10
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`23
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`17
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`21-----\--\--t:=-~,..Jf"
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`19
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`14
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`Fig. 8
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`Sheet 8 of 14
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`10
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`24
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`Fig. 9
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`Sheet 9 of 14
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`US 9,457,154 B2
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`Fig. 10
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`Sheet 10 of 14
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`US 9,457,154 B2
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`10
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`Fig. 11
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`Fig. 12
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`Fig. 13
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`Fig. 14
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`1
`INJECTION DEVICE WITH AN END OF
`DOSE FEEDBACK MECHANISM
`
`CROSS-REFERENCE TO RELATED
`APPLICATIONS
`
`This application is a 35 U.S.C. §371 national stage
`application of International Patent Application PCT/
`EP2006/000486 (published as WO 2006/079481), filed Jan.
`20, 2006, which claimed priority of European Patent Appli(cid:173)
`cation 05075187.4, filed Jan. 25, 2005; this application
`further claims priority under 35 U.S.C. §119 of U.S. Provi(cid:173)
`sional Application 60/647,491, filed Jan. 27, 2005.
`
`FIELD OF THE INVENTION
`
`The present invention relates to an apparatus for deliver(cid:173)
`ing liquid drugs to a mammal, preferably a human being,
`preferably in a subcutaneous manner. More particularly, the
`present invention relates to an injection device which is
`capable of providing a non-visual feedback signal to a user
`indicating that a set dose has been injected by the injection
`device.
`
`BACKGROUND OF THE INVENTION
`
`In the present disclosure reference is mainly made to the
`treatment of diabetes by injection of insulin. However, this
`is merely an exemplary use of the present invention. Thus,
`the present invention may be used for injection of any other
`suitable kind of drug, e.g. growth hormone.
`Injection devices, e.g. in the form of injection pens, are
`mainly made for users who have to inject themselves
`frequently, e.g. people having insulin-dependent diabetes or
`needing treatment by growth hormones. A number of
`requirements are set to such injection devices. The setting of
`a dose must be easy and unambiguous and it must be easy
`to read the set dose. Furthermore, it must be possible, with
`a minimum of trouble, to cancel or change a wrongly set
`dose. Finally, when the dose is injected the dose setting
`mechanism must return to zero. This is very important since
`it ensures that the set dose is actually injected, thereby
`allowing the user to keep track of which dose is injected.
`Many injection devices work with a threaded piston rod
`which cooperates with a nut, the nut and the piston being 45
`capable of rotating relatively to each other. The dose setting
`may 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
`abuts the stop. In other injection devices one of the elements,
`the nut or the piston rod, is kept inrotatable while the other
`one is allowed to rotate a set angle depending on the set
`dose, whereby the piston rod is dialed a distance in a forward
`direction through the nut member.
`In such prior art injection devices a dose is normally set
`by dialing a dose setting member, and the set dose is injected
`by pushing an injection button. In elongated pen shaped
`injection devices the dose setting member and the injection
`button normally form a single member. When the injection
`button is pushed the set dose is expelled. However, the
`amount of drug expelled is only equal to the set dose if the
`injection button has been pushed as far as possible, the dose
`setting member thereby having been brought back to zero. In
`order to ensure that the correct dose has actually been 65
`injected, the user therefore has to visually inspect the
`position of the dose setting member during the injection.
`
`SUMMARY OF THE INVENTION
`
`It is, thus, an object of the present invention to provide an
`injection device being capable of precisely and in a non(cid:173)
`visual manner indicating to a user when a set dose has been
`injected.
`
`10
`
`25
`
`2
`This is disadvantageous because the injection in some cases
`will take place in a part of the body where visual inspection
`during the injection is very difficult or even impossible.
`Furthermore, in case the user is visually impaired it may be
`5 difficult for the user to visually inspect the dose setting
`member during or after the injection, regardless of where on
`the body the injection is performed. Since it is not uncom(cid:173)
`mon for people having diabetes to be visually impaired, this
`is an important 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 which makes it unnecessary
`for the user to visually inspect whether or not the set dose is
`15 injected.
`Some prior art injection devices have a mechanism which
`informs the user that a dose is being injected by producing
`an audible 'click' for each dose unit being injected. How(cid:173)
`ever, since these clicks appear during the entire injection
`20 they do not provide a feedback signal indicating that the set
`dose has been injected, and the problem indicated above is
`therefore not solved by these injection devices. Prior art
`injection devices of this type are, e.g., described in U.S. Pat.
`No. 4,592,745, EP O 688 571 and US 2004/0210199.
`In WO 98/57688 an injection device is disclosed which
`addresses
`the above mentioned problem. Thus, WO
`98/57688 discloses an injection device having a dose setting
`device. A dose is set by dialing a dose setting member. Apart
`from setting a dose the dialing action causes an injection
`30 button to be moved from a position where it abuts a housing
`of the injection device to a position where it protrudes from
`the housing. The set dose is subsequently delivered by
`pushing the injection button back into abutment with the
`housing. In one embodiment a lock is activated when the
`35 injection button reaches the housing, and the activation of
`the lock produces an audible click indicating that the injec(cid:173)
`tion button is in abutment with the housing and thereby that
`the set dose has been delivered. During the injection, includ(cid:173)
`ing the final part when the lock is activated, the injection
`40 button is moved linearly. The linear distance traveled by the
`injection button during the last few doses is relatively short.
`It may therefore be difficult to determine accurately from the
`audible click produced by the lock whether or not and when
`the set dose has been delivered.
`EP O 594 357 discloses another injection device which
`addresses the above mentioned problem. Thus, EP O 594 357
`discloses an injection device having a top section with
`resilient legs depending perpendicularly from the top sec(cid:173)
`tion. The outer surface of the resilient legs has a ridge which
`50 rests on a ledge inside of the dose knob. The dose knob may
`have an elongated section which fits into a cylindrical sleeve
`such that when the dose knob is pushed into the sleeve, at the
`end of injection, the top portion of the sleeve touches end of
`the leg of the resilient legs displacing the ridge from the
`55 ledge and causing a snapping noise. As it is the case with the
`injection device described in WO 98/57688, the dose knob
`is moved linearly during injection, also during the final part
`of the injection when the resilient legs are displaced from the
`ridge causing the snapping noise. Therefore the shortcom-
`60 ings described above are also applicable here.
`
`

`

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`3
`It is a further object of the present invention to provide an
`injection device being capable of non-visually indicating to
`a user when 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 5
`provide a dose delivering mechanism for an injection
`device, the dose delivering mechanism being capable of
`precisely and in a non-visual manner indicating to a user
`when a set dose has been injected.
`According to the present invention the above and other 10
`objects are fulfilled by providing an injection device com-
`prising:
`a housing,
`a dose setting member being operable to set a desired dose
`to be injected,
`a piston rod being adapted to cooperate with a piston so
`as to cause a set dose to be injected from an ampoule,
`and
`a dose delivering mechanism being 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 feedback signal to a user only at
`the end of injection of a set dose,
`wherein first and second parts of the injection device are
`adapted to perform a relative rotational movement with
`respect to each other during injection of a dose, and wherein
`said relative rotational movement causes at least two parts of
`the injection device to abut or engage, said abutment or
`engagement causing the non-visual feedback signal to be
`generated.
`The injection device of the present invention 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 35
`being set by means of the dose setting member is, thus, a
`dose of a specific drug which the person in question needs
`to inject at that specific point in time. The desired dose may
`be a fixed dose which the person needs to inject each time
`an injection is performed, or it may be a varying amount, e.g. 40
`varying according to the time of day and/or one or more
`parameters which may be measured or chosen prior to
`setting the dose (e.g. blood glucose (BG) level, contents of
`a meal, etc.).
`The piston rod is preferably adapted to push a piston into 45
`an ampoule, thereby causing the set dose to be injected. This
`may be obtained in various ways and is well known and well
`described in the art.
`The dose delivering mechanism is adapted to provide a
`non-visual feedback signal to a user only at the end of
`injection of a set dose. Thus, the feedback signal may be
`generated when the set dose has been injected, e.g. exactly
`when or immediately after the last unit has been injected.
`Alternatively, the feedback signal may be generated before
`the complete dose has been delivered, e.g. when a few units
`remain to be injected, the remaining units being injected
`while the feedback signal is sensed by the user. Thus, when
`the user perceives the feedback signal the set dose will have
`been delivered, and the user will therefore not be able to tell
`the difference between a feedback signal being generated 60
`after the dose has been completely injected and a feedback
`signal being generated immediately before the dose has been
`completely injected. In any event the user can regard the
`perception of the feedback signal as an indication that the set
`dose has been delivered, and the user may therefore react
`correspondingly, e.g. by removing a pressure applied manu(cid:173)
`ally to an injection button.
`
`4
`Since the non-visual feedback signal is provided only at
`the end of injection of a set dose the user will know distinctly
`that when the feedback signal is received the set dose has
`been fully injected. This is an advantage compared to prior
`art injection devices where 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
`been fully injected.
`A first part and a second part of the injection device are
`adapted to perform a relative rotational movement with
`respect to each other during injection of a dose. This 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,
`15 e.g. the housing and/or the piston rod, the sole purpose of the
`separate member being to generate the non-visual feedback
`signal. Three or more parts of the injection device may
`perform mutual rotational movements during injection of a
`dose. Furthermore, the relative rotational movement may be
`20 performed all through the injection of a dose or it may be
`performed during only part of the injection. Thus, the
`relative rotational movement may be started or stopped at
`the end of injection of a set dose as defined above, in which
`case this starting or stopping may advantageously cause the
`25 non-visual feedback signal to be generated.
`The relative rotational movement causes at least two parts
`of the injection device to abut or engage, and this abutment
`or engagement causes the non-visual feedback signal to be
`generated. One or both of the parts which abut or engage
`30 may be the first and/or second parts, i.e. the parts performing
`the relative rotational movement. Alternatively, one or both
`of the parts which abut or engage may be other parts of the
`injection device. This will be described in further details
`below.
`Due to the fact that the relative rotational movement
`initiates the generation of the non-visual feedback signal it
`is ensured that the movement generating the non-visual
`feedback signal is much longer than a corresponding move(cid:173)
`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 much more precise and
`distinct, and a far more accurate feedback signal has thereby
`been provided. This is very advantageous because it makes
`it much easier for the person to ascertain that the expected
`and desired dose has actually been injected.
`The non-visual feedback signal may comprise an audible
`and/or a tactile signal. In this case the person using the
`injection device will be able to hear and/or feel that the set
`dose has been injected. Alternatively or additionally, the
`50 non-visual feedback signal may comprise any other suitable
`kind of signal which can be perceived by other senses than
`sight. Furthermore, the non-visual feedback signal may be
`followed by a visual signal, e.g. a scale drum showing a
`'zero', a lamp or a diode which is turned on or off or starts
`55 flashing simultaneously with the generation of the non(cid:173)
`visual feedback signal. Thereby the user may, in addition to
`the non-visual feedback signal, use this visual feedback
`signal to further ensure that the set dose has actually been
`injected.
`In one embodiment of the present invention the abutment
`or engagement is caused by a change in a rotational velocity
`of at least one part of the dose delivering mechanism. This
`may, e.g., be accomplished by allowing a separate member
`to start rotating at the end of injection of a set dose, typically
`65 in such a way that this member rotates during injection of the
`last few units of the set dose. The rotation of this separate
`member will in turn generate a non-visual feedback signal to
`
`

`

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`5
`the user. Thus, in this case the rotational velocity of this
`member relatively to, e.g., the housing, changes from zero to
`a certain velocity, and this change causes the non-visual
`feedback signal to be generated, e.g. in the form of a clicking
`sound generated by protruding parts present on the separate 5
`member moving against an inner part of the housing or an
`outer part of the piston rod.
`Alternatively or additionally, the change in rotational
`velocity may cause a tactile feedback signal to be generated.
`It may, e.g., be possible to feel the rotational movement 10
`itself, and thereby it may be possible for the user to detect
`a substantial change ( decrease or increase) in the rotational
`velocity.
`In one embodiment the injection device may further
`comprise a ratchet operating the piston rod and having a 15
`threaded portion being adapted to engage with a part of the
`dose delivering mechanism, in which case the change in a
`rotational velocity is generated by a change in the pitch of
`the threaded portion of the ratchet, said change in the pitch
`in return causing a change in a translational velocity of said 20
`part of the dose delivering mechanism, said change in
`translational velocity causing at least two parts of the
`injection device to abut, thereby causing the non-visual
`feedback signal to be generated.
`In this embodiment the non-visual feedback signal pref- 25
`erably comprises a tactile feedback signal. Thus, the part of
`the dose delivering mechanism which is adapted to engage
`with the threaded portion of the ratchet is preferably in
`directly or indirectly contact with the user during injection
`of a dose. Thus, the part may be, form part of or be 30
`operatively connected to an injection button which the user
`presses during injection. Thereby the user will be able to feel
`the change in translational velocity.
`The pitch may be changed from a certain value used
`during the main part of the injection to zero, i.e. the threaded 35
`portion simply stops at a position corresponding to the end
`of injection of a set dose. In this case the user will feel a kind
`of 'axial resistance' during the injection until the ratchet/
`dose delivery part reaches the position where the threaded
`portion stops. Then the part will stop rotating and instead 40
`increase the velocity of a translational (axial) movement
`which is also performed while the ratchet/dose delivery part
`travels the threaded portion, due to the pitch of the threaded
`portion. The user will be able to feel this increase in
`translational velocity. Furthermore, the translational move- 45
`ment is preferably eventually stopped, e.g. due to part of the
`dose delivery mechanism abutting a stop member. This stop
`will also be very distinctly felt by the user, thereby produc(cid:173)
`ing a non-visual feedback signal, and it may further produce
`a sound, in which case the non-visual feedback signal 50
`comprises a tactile as well as an audible signal. In this
`embodiment the two parts of the injection device which are
`caused to abut may advantageously be a scale drum and a
`part of the housing, the scale drum performing a rotational
`and axial movement defined by the threaded portion. Alter- 55
`natively, the two parts may be a dose knob and a proximal
`part of the housing, the dose knob performing an axial
`movement which follows the axial part of the movement of
`the scale drum as described above.
`Alternatively, the pitch may either increase or decrease
`from one non-zero value to another. This has the advantage
`that the engaging part is readily moved back into engage(cid:173)
`ment with the threaded portion when a new dose is to be set.
`In another embodiment the dose delivering mechanism
`may comprise a first dose part and a second dose part, the
`first dose part being adapted to rotate relatively to the
`housing during injection of a dose and the first dose part
`
`6
`comprising means for engaging the second dose part at the
`end of injection of a set dose, thereby causing the second
`dose part to rotate along with the first dose part, in which
`case the non-visual feedback signal is generated by the
`resulting rotational movement of the second dose part.
`In this embodiment the rotational movement of the second
`dose part increases from zero to a non-zero value at the end
`of injection of the set dose. The second dose part may be
`provided with teeth, protrusions, flexible arms or similar
`means being adapted to be moved against another part of the
`device during rotation of the second dose part, thereby
`producing a sound which at least partly constitutes the
`non-visual feedback signal.
`The second dose part may be positioned between the first
`dose part and the housing. In case the second dose part is
`provided with teeth, protrusions, flexible arms or the like as
`described above, these may advantageously be moved
`against a part of the housing when the second dose part is
`rotated along with the first dose part.
`Alternatively, the non-visual feedback signal may be
`generated as a result of an abutment between two parts of the
`dose delivering mechanism performing a relative rotational
`movement. The feedback signal may, e.g., be obtained by
`releasing a tension which has previously been introduced in
`a part of the injection device, the release of the tension being
`caused by the abutment between the two parts.
`The tensed part may comprise a spring means, such as a
`separate spring member or at least one resilient portion of at
`least one of the first and second parts performing the relative
`rotational movement. In case the spring means is in the form
`of at least one resilient portion of the part(s) the non-visual
`feedback signal may be generated in the following marmer.
`First the resilient portion(s) is/are bent into a tensed position.
`At a later time this tension is released, e.g. by rotating the
`resilient portion(s) away from a part which holds the resil(cid:173)
`ient portion(s) in the tensed position. Thereby the resilient
`portion(s) will restore its/their relaxed position(s), and this
`movement will generate a clicking sound, i.e. a non-visual
`feedback signal. The resilient portion(s) may be in the form
`of spring arm(s), in which case a sound may be generated
`due to moving air caused by sudden release of the tensed
`spring arm(s). Alternatively, abutment between a moving
`part and a release mechanism may release the tension of the
`resilient portion(s).
`The tension may be introduced during dose setting, e.g. by
`tightening a spring member or moving a resilient portion
`into a tensed position as described above. This may be
`obtained by letting the dose setting mechanism be connected
`to a spring member, e.g. in such a way that a spring is
`tightened when a dose setting member is turned, or in such
`a way that a part being provided with a resilient portion is
`rotated along with a dose setting member, thereby causing
`the resilient part to be moved into a tensed position.
`Alternatively, the tension may be introduced during injec(cid:173)
`tion of a dose. This may be obtained in a manner very similar
`to what is described above. However, in this case the tensed
`part should be operatively connected to the dose delivering
`mechanism.
`The dose delivering mechanism may be adapted to be
`60 manually operated, e.g. by means of an injection button
`which the user must press manually during the injection.
`Alternatively, the dose delivering mechanism may be
`adapted to be operated by means of a mechanically biased
`mechanism, e.g. comprising at least one spring. The
`65 mechanically biased mechanism may, in this case, be biased
`during setting of a dose. When the injection is subsequently
`performed this is done by releasing the tension previously
`
`

`

`Case 1:22-cv-00023-JPB Document 2-8 Filed 03/18/22 Page 21 of 25 PageID #: 273
`
`US 9,457,154 B2
`
`7
`built up in the mechanically biased mechanism, and the
`stored energy will then cause the set dose to be injected. This
`kind of injection device does not require a force applied by
`the user in order to inject a set dose.
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`
`The invention will now be further described with refer(cid:173)
`ence to the accompanying drawings in which:
`FIG. 1 shows a cross section through an injection device
`according to a first embodiment of the invention and being
`in a position where a dose has been set,
`FIG. 2 shows a cross section through the injection device
`of FIG. 1 in a position where a dose has been injected,
`FIG. 3 shows a click item adapted to be positioned in the 15
`injection device of FIGS. 1 and 2,
`FIG. 4 shows a threaded inner part being 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 20
`engage with the inner part of FIG. 4,
`FIG. 6 is a cross section along line A-A in FIG. 5,
`FIGS. 7-10 show parts of injection devices according to
`a third, fourth, fifth and sixth embodiment of the invention,
`respectively, all having a spring arm and a wedge structure, 25
`FIG. 11 shows part of an injection device according to a
`seventh embodiment of the invention having a spring arm
`and a release mechanism,
`FIG.12 shows an outer part of the injection device of FIG.
`11 from a different angle, and
`FIGS. 13-15 show part of an injection device according to
`an eighth embodiment of the invention having a spring arm,
`at various points in time.
`The Figures are schematic and simplified for clarity, and
`they only show details which are essential to the understand- 35
`ing of the invention while other details are left out. Through(cid:173)
`out the description of the drawings the same reference
`numerals will be used for identical or corresponding parts.
`
`8
`button 3 there is positioned a click item 5 which is provided
`with a set of teeth 6 being adapted to engage with a
`corresponding tooth 7 positioned on a ratchet 8. During
`injection the ratchet 8 will rotate relatively to the housing 4
`5 while the click item 5 will not rotate.
`FIG. 2 shows a cross section of the injection device 1 of
`FIG. 1. However, in FIG. 2 a dose has just been injected, i.e.
`the dose setting and injection button 3 has been pushed to a
`position inside the housing 4. Thereby the set of teeth 6 on
`1