(19) 0
`
`)
`
`E"*°"““s°“°s"a‘°"‘am‘
`
`European Patent Office
`Office européen des brevets
`
`llllllllllllllllllllllllllllllllIllllllllllllllllllllllllllllllllllllllllll
`
`(11)
`
`EP 0 608 343 B1
`
`(12)
`
`EUROPEAN PATENT SPECIFICATION
`
`(45) Dale of publication and mention
`of the grant of the patent:
`10.12.1997 Bulletin 1997/50
`
`(21) Application number: 929223220
`..
`(22) Date offlllngr 07-09-1992
`
`(51) Int. C|.6: A61 M 5/315, A61 M 5/24
`
`(86) International application number:
`PCT/DK92/00267
`
`(87) International publication number:
`wo 93/07922 (29.04.1993 Gazette 1993/11)
`
`(54) LARGE DOSE PEN
`
`STIFI'ARTIGE SPRITZE FUR GROSSE DOSIERUNGEN
`
`SERINGUE SOUS FORME DE STYLO SERVANT A DES INJECTIONS DE DOSES REPETITIVES
`
`(84) Designated Contracting States:
`AT BE CH DE DK ES FR GB GR IE IT LI LU NL SE
`
`- HANSEN, Niels-Aage, B.
`DK-4622 Havdrup (DK)
`
`(30) Priority: 18.10.1991 DK1754/91
`
`(43) Date of publication of application:
`03.08.1994 Bulletin 1994/31
`
`(73) Proprietor: NOVO NORDISK NS
`2880 Bagsvaerd (DK)
`
`(72) Inventors:
`- PETERSEN, Lars, Peder, Klitmose
`DK-2820 Gentofte (DK)
`
`(74) Representative:
`Hansen, Einar Tronier et al
`c/o Novo Nordisk A/S,
`Patent Department,
`Novo Allé
`2880 Bagsvaerd (DK)
`
`(56) References cited:
`EP-A- 0 293 572
`EP-A- 0 450 905
`
`EP-A- 0 327 910
`
`
`
`Note: Within nine months from the publication of the mention of the grant of the European patent, any person may give
`notice to the European Patent Office of opposition to the European patent granted. Notice of opposition shall be filed in
`a written reasoned statement.
`It shall not be deemed to have been filed until the opposition fee has been paid. (Art.
`99(1) European Patent Convention).
`
`Primed by Xerox (UK) Business Services
`2.15.394
`
`Mylan Exhibit - 1032
`
`Mylan V. Sanofi
`
`EP0608343B1
`
`Mylan Exhibit - 1032
`Mylan v. Sanofi
`
`

`

`1
`
`EP 0 608 343 B1
`
`2
`
`Description
`
`The invention relates to a pen shaped syringe for
`repetitive injection oi individually set doses of a medi-
`cine from a reservoir in the syringe.
`Such pen syringes are especially used by diabetics
`who have to inject themselves frequently with an insulin
`preparation to keep their blood glucose level within tol-
`erable limits.
`
`With the appearance of insulin preparations having
`a retarded action and of mixed preparations which make
`it possible to inject at the same time a preparation meet-
`ing an immediate need for insulin and a preparation cov-
`ering the basic need for a long time, the time between
`injections is increased and so are the doses adminis-
`tered at each injection.
`The doses are mainly set by rotating part of the pen
`syringe relatively to the rest of the syringe and numbers
`forming a scale along an edge of the one rotatable part
`of the syringe are moved in relation to an indicating
`mark on the rest of the syringe to indicate the set dose.
`Hereby the dose is limited by the fact that only a limited
`number of numbers can be placed along the edge oi the
`rotatable part if they shall be readable at all. This prob-
`lem is overcome by imparting the rotatable part an axial
`displacement concurrently with its rotation whereby
`instead oi a circle a helical line becomes available for
`
`dose indicating numbers and even a scale covering
`rotation in excess of one turn.
`
`The pen syringe should be as simple as possible to
`use, i.e. the normal use should only imply setting a dose
`and injecting the set dose, and both these steps should
`be simple to perform and this condition is met by most
`pen syringes. However, not all pen syringes offer the
`opportunity to cancel a set dose, so if a dose once set is
`not wanted for injection the only way to bring the syringe
`back in its neutral position is to spill the dose. With
`syringes by which large doses may be set this is not
`acceptable.
`By a known type of syringe the scale is arranged
`along a helix having just one turn. A helical recess in a
`cylinder surface of a dose setting member is engaged
`by a pin on the syringe housing so that the dose setting
`member when rotated is axially displaced along its axis.
`After having been axially displaced by the setting of a
`dose, the dose setting member is pressed home to
`inject the dose. The engagement between the pin and
`the helical recess will cause a rotation of the dose set-
`
`ting member when it is axially pressed home, this rota-
`tion being in the opposite direction of the rotation for
`setting the dose. The rotation of the dose setting mem-
`ber is transferred to a screw/nut mechanism driving a
`piston in the syringe forward a distance proportional to
`the rotation.
`The ends oi the one turn helical recess are con-
`
`nected by an axial recess. This enables the setting
`member to be pressed axially back without imparting a
`rotary movement to this member if the rotary position of
`the member is so that the pin on the syringe housing
`
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`engages the axial recess instead of the helical part of
`the recess. In this way a set dose may be cancelled by
`turning the dose setting member further until the pin
`engages the axial recess. However, this canceling fea-
`ture limits the effective dose setting rotation of the dose
`setting member to a little less than one turn, and iurther,
`as the demands for precision of the injected dose set a
`limit to the size of the dose per turning of the screw/nut
`mechanism, the size of the possible set dose is heavily
`restricted.
`
`Consequently, it is the object oi the invention to pro-
`vide a pen syringe by which large doses may be set, a
`set dose may be cancelled, and the possibility of can-
`cellation does not influence the possible size of a set
`dose or the simplicity of the normal use of the syringe.
`This is obtained by a pen shaped syringe for repet-
`itive injection of individually set doses of a medicine
`from a cylinder ampoule reservoir, comprising a dose
`setting member which may be rotated to cause a rota-
`tive movement of a dosing member and a combined
`rotative and axial movement of an indicator member
`
`indicating the set dose, a piston drive member which
`when rotated in one direction moves the piston into the
`cylinder ampoule, a unidirectional coupling between the
`dosing member and the piston drive member, the cou-
`pling being so directed that a dose setting rotation oi the
`dosing member is not transferred to the piston drive
`whereas a rotation in the opposite direction is,
`this
`syringe being characterized in, that a nut/screw connec-
`tion is established between a syringe housing and the
`dose setting member, and that means are provided to
`release the unidirectional coupling between the piston
`drive member and the dosing member.
`The nut/screw connection provides by mutual
`engaging threads a more stable guidance of the dose
`setting member than does a pin engaging a recess. As
`the canceling mechanism is not based on an axial
`recess as a return path, the dosing rotation of the dose
`setting member may be performed for more than one
`turn, and thereby it is permitted to set a larger dose than
`the one which can be provided by rotating the piston
`drive one turn. The cancelling mechanism is realized as
`a coupling which may disconnect the dosing member
`from the piston drive, so that the dose setting member
`and the dosing member may be rotated back without the
`rotation being transmitted to the piston drive.
`The thread of the screw/nut connection of the dos-
`
`ing member and the housing may have a pitch angle
`exceeding the iriction angle of the nut and screw.
`Thereby the dosing rotation of the dose setting member
`may be obtained by simply pressing this member axially
`back, whereby the screw will automatically screw itself
`through the nut and provide a rotative movement of the
`dose setting member in the dosing direction. This auto-
`matic dosing screw function may more easily be
`obtained if the outer end oi the dosing member is termi-
`nated by a knob wherein a press button is journaled, the
`button and the knob having mutually abutting surfaces
`made of materials having a friction angle lower than the
`
`Mylan Exhibit - 1032
`
`Mylan V. Sanofi
`
`Mylan Exhibit - 1032
`Mylan v. Sanofi
`
`

`

`3
`
`EP 0 608 343 B1
`
`4
`
`friction angle of the nut/screw connection.
`
`a unidirectional coupling.
`
`According to an embodiment of the invention, the
`dose setting member may comprise a threaded spindle,
`the dosing member may be tubular and fit over this spin-
`dle, and the spindle may have axial recesses engaged
`by corresponding axial beams on the inner side of the
`bore of the dosing member. Thereby a dosing member
`is provided which will follow rotary but not axial move-
`ments of the dose setting member.
`The unidirectional coupling between the dosing
`member and the piston drive may be provided by cou-
`pling parts having circular surfaces provided with sector
`shaped teeth having an abrupt and a ramp shaped
`edge, the surfaces by a spring being forced against
`each other with the ramp shaped edge of the teeth on
`one surface abutting the ramp shaped edge of the teeth
`on the other surface. When the dose setting member is
`rotated in the dose setting direction, the teeth on the
`coupling parts will slide with their ramp shaped parts
`over each other, whereby the dosing member is axially
`displaced against the force of the spring and will jump
`back each time an abrupt edge of the teeth is reached.
`Each jump back may be heard and sensed by the oper-
`ator, and the pitch of the toothing may be chosen so that
`a jump back takes place each time the dose setting is
`increased by say one unit.
`The coupling mechanism may be provided by the
`syringe having a tubular basic element, a tubular ele-
`ment surrounding the basic element coaxially with it and
`axially displaceable in relation thereto against the force
`of a spring forcing the tubular element to a fixed position
`on the basic element, and a lifting fork carried by the
`tubular element and engaging an outer annual projec-
`tion on the dosing member to lift the coupling part
`thereof out of engagement with the coupling part of the
`piston drive when the tubular member is axially dis-
`placed on the basic element against the force of the
`spring away form its fixed position.
`In the following the invention will be further
`described with references to the drawings, wherein
`
`Figure 1
`
`Figure 2
`
`Figure 3
`
`Figure 4
`
`Figure 5
`Figure 6
`
`Figure 7
`
`is a sectional side view of a pen shaped
`syringe according to the invention,
`is an enlarged view of the part of the
`syringe in Figure 1 containing the dosing
`mechanism,
`shows a cross section along the line lll-lll
`in Figure 2,
`shows a side view of the pen syringe in Fig-
`ure 1 separated into a part comprising the
`dosing mechanism, a cartridge holder, and
`a cap,
`shows the syringe in Figure 4 put together,
`shows a side view of the syringe with the
`cap removed and the dosing mechanism
`part and the cartridge holder drawn away
`from each other to allow a canceling of a
`set dose, and
`shows schematically the coupling discs of
`
`The pen syringe shown in Figs. 1-6 is built up
`around a tubular basic member 1 having at its one end
`a part 42 with enlarged diameter, this part by an annular
`projection being divided into two, a first part being pro-
`vided with a thread onto which a cartridge holder 2 may
`be screwed and a second part receiving a tubular mem-
`ber 8. The cartridge holder 2 comprises a tubular ele-
`ment designed to accommodate a cartridge and having
`in its side walls axially extending openings through
`which the contents of the cartridge may be inspected.
`Along one of the openings a recessed part 4 of the side
`wall
`is provided with a scale showing the available
`amount of medicine, here as the number of international
`units of insulin. At its distal end the cartridge holder 2 is
`provided with not seen protrusions protruding inwardly
`from the cartridge holder wall to hold back the cartridge
`in the holder and cooperating with an adapter top 5 on
`the neck part of the cartridge. This adaptor top 5 pro-
`trudes from the end of the cartridge holder 2 and is pro-
`vided with an outer thread onto which a needle hub 6 is
`
`screwed to secure the cartridge in the holder 2. A tubu-
`lar protective cap 3 may be passed over the cartridge
`holder 2 when the syringe is not in use.
`The tubular member 8 fits with its one end over the
`
`second part of the enlarged diameter part 42 of the one
`end of the basic member 1 and abuts with its edge
`against the annular projection 7. The other end of the
`tubular member 8 has a reduced diameter and fits over
`the basic member 1 and is at its outer end surmounted
`
`by a part 9 having a further reduced diameter and car-
`rying an internal thread in engagement with an outer
`thread on a tubular spindle 10.
`A spring 11 is provided abutting at its one end an
`annular internal projection 12 in the bore of the basic
`member 1 and pressing at its other end against a bush-
`ing 41 transferring the pressure to a set of lifting forks
`13, the function of which will be described below, and
`which forks 13 carried guidingly in openings spaced
`along the perimeter of the member 8 transfer the pres-
`sure to the member 8 keeping the edge thereof in abut-
`ment with the projection 7 on the basic member 1.
`Through slots 43 in the wall of the tubular basic member
`1 the lifting forks 13 project into the bore of the basic
`member and may be displaced axially in these slots.
`The spindle 10 is at its end extending beyond the
`part 9 secured to a dose setting knob 14 and may be
`rotated by rotating this knob 14. When rotated in one
`direction the spindle 10 and consequently the knob 14
`are displaced axially away from the tubular member 8.
`An indicating sleeve 15 is secured to the knob 14
`and forms a skirt dependent from the knob 14 and being
`accommodated in the space between the member 8
`and a tubular housing 16 mounted on the large diameter
`part of this member 8. A window in the tubular housing
`16 is provided with a magnifying glass 17,
`through
`which the sleeve 15 may be inspected along a helical
`line, when it is rotated and simultaneously axially dis-
`
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`30
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`
`Mylan Exhibit - 1032
`
`Mylan V. Sanofi
`
`Mylan Exhibit - 1032
`Mylan v. Sanofi
`
`

`

`5
`
`EP 0 608 343 B1
`
`6
`
`placed along with the knob 14. Numbers indicating a set
`dose are printed along the helical line to show the actual
`dose through the magnifying glass 17.
`
`Rotation of the spindle 10 is transferred to a tubular
`dosing member 18 fitting over the thread of the spindle
`10. The transmission is accomplished by the spindle 10
`having one or more axial recesses in its thread engaged
`by axial beams 19 on the inner surface of the dosing
`member 18. Thereby rotative motion is transferred
`whereas axial motion is not.
`
`At its end opposite the knob 14 the dosing member
`18 forms a part 20 of a unidirectional coupling through
`which the member 18 is coupled to a piston drive com-
`prising a coupling part 21 and a drive nut 22 having an
`internal thread engaging an external thread on a piston
`rod 23 which is in its retracted position accommodated
`in the bore of the tubular spindle 10 and which is made
`unrotatable relatively to the basic member 1 by locking
`projections 24, which are mounted unrotatably in rela-
`tion to the basic member 1 and engage axial slots in the
`thread of the piston rod 23.
`The unidirectional coupling is provided by the dos-
`ing member 18 and the piston drive nut 22 having disc
`shaped coupling parts 20 and 21, respectively, having at
`the surfaces facing each other teeth each forming a part
`of a sector and each having a ramp shaped and an
`abrupt edge. These discs are shown schematically in
`Figure 7. The toothed surfaces are urged against each
`other by a spring 25 compressed between a shoulder
`26 at the upper end of the tubular member 8 and an out-
`ward flange 27 atone end of a bushing 28 having at its
`other end an inward flange 29 abutting the upper edge
`of the dosing member. When the dosing member is
`rotated in the direction by which the knob is screwed
`outwardly, the ramp shaped edges slide along each
`other displacing the coupling members away from each
`other against the force of the spring 25 until the abrupt
`edge is reached and the coupling part is displaced
`home by the force of the spring ready to start a new slid-
`ing along the ramp shaped parts. This overriding pre-
`vents the rotation from being transmitted to the piston
`drive nut 22 when the knob is rotated in the dose setting
`direction but is transmitted when the knob is rotated in
`
`the opposite direction, as the abrupt edges on the cou-
`pling parts will then engage each other. This rotation
`may be provided by pressing the knob home axially, the
`thread of the spindle having a pitch allowing it to trans-
`form the axial pressure to a rotation. To ease this mech-
`anism the knob 14 is provided with a press button 30
`journaled in the knob 14 with a lower surface of the but-
`ton abutting an upper surface of the knob, the abutting
`surfaces being made of materials which ensure low fric-
`tion.
`
`The rotation is transmitted to the piston drive part
`21 of the coupling and consequently to the piston drive
`nut 22. When the nut 22 is rotated by the transmitted
`rotation it will drive the unrotatable piston rod 23 in an
`axial direction towards the cylinder ampoule 31, and by
`a piston foot 32 the piston rod will press a piston 33 into
`
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`the cylinder ampoule 31.
`
`The piston drive part 21 of the coupling is at its
`periphery provided with resilient teeth 34 which collabo-
`rate with internal teeth 35 in a tubular member 36 rigidly
`mounted in the basic member 1
`to provide a detent
`allowing rotation of the piston drive nut 22 in an injecting
`direction but preventing rotation of the nut 22 in the
`opposite direction.
`The piston rod 23 is made unrotatable by having an
`axial recess engaged by locking projections 24 on a pis-
`ton rod lock member 37. Against the force of a spring 38
`this member is by the upper edge of the cylinder
`ampoule 31 pressed into the end of the basic member 1
`in an unrotatable engagement. When cartridge holder 2
`containing the cylinder ampoule 31 is dismounted by
`unscrewing it from the basic member 1, the spring 38
`will press the piston rod lock member 37 free of the
`basic member 1, and the piston rod may now be rotated
`as the lock member 37 may now rotate with it. Thereby
`the piston rod may be screwed back through the piston
`drive nut 22 to its retracted position. When the cartridge
`holder with a new ampoule is screwed onto the basic
`member 1, the lock member 37 is pressed back into its
`unrotatable engagement with the basic member and the
`piston rod is again made unrotatable.
`From the functions described it is seen that a dose
`
`may be set by rotating the knob 14 in the direction caus-
`ing a disengaging relative movement of the coupling
`parts 20 and 21. The parts 20 and 21 are appropriately
`toothed in a way making each of the hearable sudden
`displacements at the end of the ramps of a pair of teeth
`sliding along each other correspond to e.g. one unit.
`When the knob 14 is screwed home, which may be
`done by pressing the button 30, the rotation is transmit-
`ted to the piston drive nut 22 causing a forward move-
`ment of the piston corresponding to the set dose.
`If a set dose should be cancelled it is obtained by
`gripping the cartridge holder 2, which is secured to the
`basic element 1, and the tubular housing 16, which is
`secured to the tubular member 8, and by drawing the
`cartridge holder 2 and the tubular housing 16 axially
`away from each other. Thereby the tubular member 8 is
`axially displaced in relation to the basic member 1, and
`the spring 11 maintaining the tubular member 8 in posi-
`tion on the basic member 1
`is further compressed. By
`this displacement the lifting forks 13 inserted in open-
`ings in the tubular member 8 are displaced until the
`lower one of their prongs 39 extending inwardly through
`slots in the basic member 1 abuts an annular projection
`40 on the dosing member 18. A further displacement
`against the force of the spring 11 will displace the dos-
`ing member 18 against the force of the spring 25 and
`bring the coupling parts 20 and 21 out of their mutual
`engagement. Now the dosing part can freely be rotated
`without the rotation being transmitted to the piston drive
`nut, and consequently a set dose may be cancelled by
`turning the dose setting knob 14 back to its initial posi-
`tion, possibly by pressing it home.
`When released the member 8 will by the spring 11
`
`Mylan Exhibit - 1032
`
`Mylan V. Sanofi
`
`Mylan Exhibit - 1032
`Mylan v. Sanofi
`
`

`

`7
`
`EP 0 608 343 B1
`
`8
`
`be pressed back into its original position, and the dosing
`member 18 will be moved back by the spring 25 to its
`nut driving position.
`
`Claims
`
`1. A pen shaped syringe for repetitive injection of indi-
`vidually set doses of a medicine from a cylinder
`ampoule reservoir, comprising tubular member (8),
`a dosing member (18), a dose setting member
`(10,14) which may be rotated to cause a rotative
`movement of the dosing member (18) and a com-
`bined rotative and axial movement of an indicator
`
`member (15) indicating the set dose, a piston drive
`member (22) which when rotated in one direction
`moves the piston into the cylinder ampoule, a unidi-
`rectional coupling between the dosing member (18)
`and the piston drive member (22), the coupling
`being so directed that a dose setting rotation of the
`dosing member (18) is not transferred to the piston
`drive, whereas a rotation in the opposite direction
`is, characterized in, that a nut/screw connection
`(9)
`is established between the syringe tubular
`member (8) and the dose setting member (10,14),
`and that means (13,40) are provided to release the
`unidirectional coupling (20,21) between the piston
`drive member (22) and the dosing member (18).
`
`A syringe according to claim 1, characterized in,
`that the thread of the nut/screw connection (9) has
`a pitch angle exceeding the friction angle of the nut
`and screw.
`
`A syringe according to claim 2, characterized in,
`that the outer end of the dose setting member
`(10,14) is terminated by a knob (14) wherein a
`press button (30) is journaled, the button (30) and
`the knob (14) having mutually abutting surfaces
`made of materials having a friction angle lower than
`the friction angle of the nut/screw connection (9).
`
`A syringe according to claim 1, 2 or 3, character-
`ized in, that the dose setting member (10,14) com-
`prises a threaded spindle (10),
`that the dosing
`member (18) is tubular and fits over this spindle
`(10),
`that
`the spindle (10) has axial
`recesses
`engaged by corresponding axial beams (19) on the
`inner side of the bore of the dosing member (18).
`
`A syringe according to claim 4, characterized in,
`that the unidirectional coupling between the dosing
`member (18) and the piston drive (22) is provided
`by coupling parts (20,21) having circular surfaces
`provided with sector shaped teeth having an abrupt
`and a ramp shaped edge, the surfaces being by a
`spring (25) forced against each other with the ramp
`shaped edge of the teeth on one surface abutting
`the ramp shaped edge of the teeth on the other sur-
`face.
`
`6. A syringe according to claim 5, characterized in,
`that it comprises a tubular basic element (1), the
`tubular member (8) surrounding the basic element
`(1) coaxially and being axially displaceable in rela-
`tion thereto against the force of a spring (1 1) forcing
`the tubular member (8) to a fixed position on the
`basic element (1), and a lifting fork (13) carried by
`the tubular member (8) and engaging an outer
`annular projection (40) on the dosing member (18)
`to lift the coupling part (20) thereof out of engage-
`ment with the coupling part (21) of the piston drive
`(22) when the tubular member (8) is axially dis-
`placed on the basic element 1 against the force of
`the spring (11) away from its fixed position.
`
`Patentanspriiche
`
`1.
`
`Stiftformige Spritze fUr die wiederholte lnjektion von
`individuell eingestellten Dosen eines Arzneimittels
`aus einem zylinderformigen Ampullenreservoir,
`umfassend ein rohrenformiges Element
`(8), ein
`Dosierelement (18), ein Dosiseinstellelement (10,
`14), das unter Herbeifiihrung einer Drehbewegung
`des Dosierelements (18) und einer kombinierten
`Drehbewegung und axialen Bewegung eines
`Anzeigeelements (15), das die eingestellte Dosis
`anzeigt, gedreht werden kann, ein Kolbenantriebs-
`element (22), das bei Drehung in einer Richtung
`den Kolben in die Zylinderampulle bewegt, eine uni-
`direktionale Kupplung zwischen dem Dosierele-
`ment (18) und dem Kolbenantriebselement (22),
`wobei die Kupplung so ausgerichtet ist, dal3 eine
`Dosiereinstelldrehung des Dosierelements
`(18)
`nicht auf den Kolbenantrieb [ibertragen wird, wah-
`rend dies bei einer Drehung in der entgegengesetz-
`ten Richtung der Fall ist, dadurch gekennzeichnet,
`daB eine Mutter/Schrauben-Verbindung (9) zwi-
`schen dem rohrenformigen Spritzenelement
`(8)
`und dem Dosiseinstellelement (10, 14) angeordnet
`ist und daB eine Einrichtung (13, 40) vorgesehen
`ist, um die unidirektionale Kupplung (20, 21) zwi-
`schen dem Kolbenantriebselement (22) und dem
`Dosierelement (18) zu losen.
`
`Spritze nach Anspruch 1, dadurch gekennzeichnet,
`daB das Gewinde der Mutter/Schrauben-Verbin-
`
`dung (9) einen Gewindewinkel aufweist, der den
`Reibungswinkel von Mutter und Schraube fiber-
`steigt.
`
`Spritze nach Anspruch 2, dadurch gekennzeichnet,
`daB das auBere Ende des Dosiseinstellelements
`
`(10, 14) in einem Knopf (14) auslauft, in dem eine
`Drucktaste (30) gelagert ist, wobei die Taste (30)
`und der Knopf (14) aneinander anstoBende Ober-
`flachen aufweisen, die aus einem Material gefertigt
`sind, deren Reibungswinkel
`langer als der Rei-
`bungswinkel der Mutter/Schrauben-Verbindung (9)
`ist.
`
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`45
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`50
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`
`Mylan Exhibit - 1032
`
`Mylan V. Sanofi
`
`Mylan Exhibit - 1032
`Mylan v. Sanofi
`
`

`

`9
`
`EP 0 608 343 B1
`
`10
`
`4. Spritze nach Anspruch 1, 2 oder 3, dadurch
`gekennzeichnet, daB das Dosiseinstellelement (10,
`14) einen mit einem Gewinde versehenen Born
`(10) aufweist, daB das Dosierelement (18) rohren-
`formig ist und [iber den Born (10) paBt und daB der
`Born (10) axiale Ausnehmungen aufweist,
`in die
`entsprechend die axialen Strahlen (19) an der
`Innenseite der Bohrung des Dosierelements (18)
`eingreifen.
`
`Spritze nach Anspruch 4, dadurch gekennzeichnet,
`daB die unidirektionale Kupplung zwischen dem
`Dosierelement (18) und dem Kolbenantrieb (22)
`durch Kupplungsteile (20, 21) mit kreisformigen
`Oberflachen bereitgestellt wird, die mit sektorformi-
`gen zahnen versehen sind, die jeweils eine abrupte
`Kante und eine rampenfc'irmige Kante aufweisen,
`wobei die Oberflachen durch eine Feder
`(25)
`gegeneinander gedrtickt werden, wobei die ram-
`penformige Kante der zahne an einer Oberflache
`an die rampenformige Kante der zahne an der
`anderen Oberflache anstht.
`
`Spritze nach Anspruch 5, dadurch gekennzeichnet,
`daB sie folgendes aufweist: ein rohrenformiges
`Grundelement (1), wobei das rohrenformige Ele-
`ment (8) das Grundelement (1) koaxial umgibt und
`axial relativ dazu gegen die Kraft einer Feder (11)
`verschiebbar ist, die das rc'ihrenformige Element (8)
`in eine fixierte Position am Grundelement
`(1)
`er'ickt, und eine Hebegabel (13), die vom rohren-
`formigen Element (8) getragen wird und in einen
`auBeren ringformigen Vorsprung (40) am Dosier-
`element (18) eingreift, um dessen Kupplungsteil
`(20) aus dem Eingriff mit dem Kupplungsteil (21)
`des Kolbenantriebs (22) zu heben, wenn das rc")h-
`renformige Element
`(8)
`in axialer Richtung am
`Grundelement (1) gegen die Kraft der Feder (11)
`weg von seiner fixierten Stellung verschoben wird.
`
`Revendications
`
`Seringue en forme de stylo destinée a une injection
`répétitive de doses individuellement réglées d'un
`médicament en provenance d‘un réservoir sous la
`forme d'une ampoule cylindrique, cette seringue
`comprenant un élément tubulaire (8), un élément
`de dosage (18), un élément de réglage de dose
`(10, 14), qui peut étre tourné pour provoquer un
`mouvement rotatif de l'élément de dosage (18) et
`un mouvement combiné rotatif et axial d'un élément
`
`indicateur (15) indiquant |a dose réglée, un élément
`d‘entrainement de piston (22) qui,
`lorsqu'il est
`entrainé en rotation dans un sens, déplace le piston
`pour qu‘il pénetre dans l'ampoule cylindrique, un
`accouplement unidirectionnel entre l‘élément de
`dosage (18) et l‘élément d'entrainement de piston
`(22), l'accouplement étant dirigé de telle maniere
`qu‘une rotation de réglage de dose de l'élément de
`
`10
`
`15
`
`20
`
`25
`
`30
`
`35
`
`40
`
`45
`
`50
`
`55
`
`dosage (18) ne soit pas transmise a l'élément
`d‘entrainement du piston,
`tandis qu'une rotation
`dans le sens contraire l'est, cette seringue étant
`caractérisée en ce qu'une connexion par écrou et
`vis (9) est établie entre l'élément tubulaire (8) de la
`seringue et l'élément de réglage de dose (10, 14) et
`en ce que des moyens (13, 40) sont prévus pour
`débloquer l'accouplement unidirectionnel (20, 21)
`entre l'élément d‘entrainement de piston (22) et
`l'élément de dosage (18).
`
`Seringue selon la revendication 1, caractérisée en
`ce que le filetage de la connexion par écrou et vis
`(9) a un angle de pas dépassant I'angle de frotte-
`ment de l'écrou et de la vis.
`
`Seringue selon la revendication 2, caractérisée en
`ce que l'extrémité extérieure de l'élément de
`réglage de dose (10, 14) se termine par un bouton
`de réglage (14), dans lequel un bouton-poussoir
`(30) est monté par un tourillon, le bouton-poussoir
`(30) et le bouton de réglage (14) ayant des surfaces
`mutuelles de butée faites en des matériaux ayant
`un angle de frottement inférieur a I'angle de frotte-
`ment de la connexion par écrou et vis (9).
`
`Seringue selon la revendication 1, 2 cu 3, caracté-
`risée en ce que l'élément de réglage de dose (10,
`14) comprend une tige filetée (10), en ce que l'élé-
`ment de dosage (18) est tubulaire et s'adapte sur
`cette tige filetée (10), en ce que la tige (10) pré-
`sente des évidements axiaux dans lesquels péne-
`trent des barrettes axiales (19) correspondantes
`situées sur le cote interne de l'alésage de l'élément
`de dosage (18).
`
`Seringue selon la revendication 4, caractérisée en
`ce que l'accouplement unidirectionnel entre l'élé-
`ment de dosage (18) et l'élément d'entrainement de
`piston (22) est constitué, par des parties d'accou-
`plement (20, 21) ayant des surfaces circulaires
`pourvues de secteurs dentés dont les dents ont un
`flanc abrupt et un flanc en rampe, les surfaces étant
`poussées l‘une contre l'autre par un ressort (25) et
`le flanc en rampe des dents d'une surface venant
`en butée contre le flanc en rampe des dents de
`l'autre surface.
`
`Seringue selon la revendication 5, caractérisée en
`ce qu'elle comprend un élément tubulaire de base
`(1),
`l'élément tubulaire (8) entourant l'élément de
`base (1) de facon coaxiale et étant axialement
`mobile par rapport a celui-ci, de maniere antago-
`niste a la force d'un ressort (11) tendant a ramener
`l'élément tubulaire (8) dans une position fixe sur
`l'élément de base (1), et une fourchetle de levage
`(13), portée par l'élément tubulaire (8) et venant en
`contact avec une protubérance annulaire extérieure
`(40) située sur l'élément de dosage (18) afin de
`
`Mylan Exhibit - 1032
`
`Mylan V. Sanofi
`
`Mylan Exhibit - 1032
`Mylan v. Sanofi
`
`

`

`11
`
`EP 0 608 343 B1
`
`12
`
`soulever Ia partie d'accouplement (20) de celui-ci
`pour la dégager de la partie d'accouplement (21)
`de I'élément d‘entrainement de piston (22) Iorsque
`I'élémeni iubulaire (8) est déplacé axialement sur
`I'élémeni de base (1), de maniére antagoniste a la
`force du ressori (11) pour I'éloigner de sa position
`fixe.
`
`10
`
`15
`
`20
`
`25
`
`30
`
`35
`
`4o
`
`45
`
`50
`
`55
`
`Mylan Exhibit - 1032
`
`Mylan V. Sanofi
`
`Mylan Exhibit - 1032
`Mylan v. Sanofi
`
`

`

`
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