`
`Europilsches
`Patentamt
`Europe: n
`Patent Office
`Office eu ropéen
`des brevets
`
`Bescheinigung
`
`Certificate
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`Attestation
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`Die angehefteten
`Unterlagen stimmen mit der
`als ursprtinglich eingereicht
`geltenden Fassung der auf
`dem nachsten Blatt
`bezeichneten europaischen
`Patentanmeldung Uberein.
`
`The attached documents are
`
`exact copies of the text in
`which the European patent
`application described on the
`following page is deemed to
`have been filed.
`
`Les documents joints a la
`présente attestation sont
`conformes au texte,
`considéré comme
`
`initialement déposé, de la
`demande de brevet
`
`européen qui est spécifiée a
`la page suivante.
`
`
`
`Patentanmeldung Nr.
`
`Patent application No.
`
`Demande de brevet n°
`
`131756595 / EP13175659
`
`The organization code and number of your priority application, to be used for filing abroad under the Paris
`Convention, is EP13175659.
`
`Der Prasident des Europaischen Patentamts;
`lm Auftrag
`For the President of the European Patent Office
`Le President de I‘Office européen des brevets
`p.o.
`
`file
`
`U. lngmann
`
`gawk
`
`EPA/EPO/OEB Form 1014
`
`05.12
`
`

`

`
`
`Anmeldung Nr:
`Application no.:
`Demande no :
`
`131756595
`
`Anmelder / Applicant(s) / Demandeur(s):
`
`Sanofi-Aventis Deutschland GmbH
`
`BriiningstraBe 50
`65929 Frankfurt am Main/DE
`
`Anmeldetag:
`Date of filing:
`Date de depot :
`
`09.07.13
`
`Bezeichnung der Erfindung [Title of the invention / Titre de l‘invention:
`(Falls die Bezeichnung der Erfindung nicht angegeben ist, oder falls die Anmeldung in einer Nicht-Amtssprache des EPA eingereicht
`wurde, siehe Beschreibung bezt'iglich ursprl'inglicher Bezeichnung.
`If no title is shown, or if the application has been filed in a non-EPO language, please refer to the description for the original title.
`Si aucun titre n'est indiqué, ou si la demande a été déposée dans une langue autre qu'une langue officielle de l'OEB, se référer a la
`description pour le titre original.)
`
`Autoinjector
`
`ln Anspruch genommene Prioritat(en) / Priority(Priorities) claimed / Priorité(s) revendiquée(s)
`Staat/Tag/Aktenzeichen / State/Date/File no. / Pays/Date/Numéro de dépét:
`
`Am Anmeldetag benannte Vertragstaaten / Contracting States designated at date of filing / Etats contractants désignées lors
`du dépét:
`
`AL AT BE BG CH CY CZ DE DK EE ES FI FR GB GR HR HU IE IS IT LI LT LU LV MG MK MT NL NO PL
`PT RO RS SE SI SK SM TR
`
`EPA/EPO/OEB Form 1014
`
`05.12
`
`2
`
`

`

`Sanofi—Aventis Deutschland GmbH
`
`DE2012/138
`
`TS
`
`Autoinjector
`
`Technical Field
`
`The invention relates to an autoinjector.
`
`Background ofthe Invention
`
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`Administering an injection is a process which presents a number of risks and challenges
`
`for users and healthcare professionals, both mental and physical.
`
`Injection devices
`
`typically fall into two categories — manual devices and autoinjectors.
`
`In a conventional
`
`manual device, manual force is required to drive a medicament through a needle. This
`
`is typically done by some form of button / plunger that has to be continuously pressed
`
`during the injection. There are numerous disadvantages associated with this approach.
`
`For example, if the button / plunger is released prematurely, the injection will stop and
`
`may not deliver an intended dose. Further, the force required to push the button /
`
`plunger may be too high (e.g., if the user is elderly or a child). And, aligning the
`
`injection device, administering the injection and keeping the injection device still during
`
`the injection may require dexterity which some patients (e.g., elderly patients, children,
`
`arthritic patients, etc.) may not have.
`
`Autoinjector devices aim to make self-injection easier for patients. A conventional
`
`autoinjector may provide the force for administering the injection by a spring, and trigger
`
`button or other mechanism may be used to activate the injection. Autoinjectors may be
`
`single—use or reusable devices.
`
`There remains a need for an improved autoinjector.
`
`30
`
`Summary of the Invention
`
`It is an object of the present invention to provide an improved autoinjector.
`
`

`

`In an exemplary embodiment, an autoinjector according to the present invention
`
`comprises a case including a rib, a needle shroud telescopically coupled to the case
`
`and movable between a first extended position, a retracted position and a locked
`
`second extended position, a carrier slidably arranged in the case, adapted to hold a
`
`medicament container, and movable from a first axial position to a second axial position
`
`relative to the case, a collar rotatably and slidably disposed in the case and coupled to
`
`the needle shroud and the carrier, and a trigger button operably coupled to the carrier.
`
`The carrier abuts the rib in the first axial position and the needle shroud is in the first
`
`extended position and disengages the rib when the needle shroud is in the retracted
`
`position and the trigger button is pressed to advance the carrier to the second axial
`
`position.
`
`In an exemplary embodiment, the autoinjector further comprises a plunger slidably
`
`coupled to the carrier, and a drive spring biasing the plunger relative to the carrier. The
`
`carrier includes a compliant beam having a boss adapted to engage an opening in the
`
`plunger when the carrier is in the first axial position. The boss is adapted to engage the
`
`case when the carrier is in the second axial position.
`
`In an exemplary embodiment, the collar includes a shroud boss adapted to engage a
`
`shroud slot in the needle shroud and a carrier boss adapted to engage a carrier slot in
`
`the carrier.
`
`In an exemplary embodiment, the collar is in a first angular position relative to the case
`
`when the needle shroud is in the first extended position and the carrier is in the first
`
`axial position. The collar rotates to a second angular position relative to the case and
`
`translates proximally relative to the case when the needle shroud moves from the first
`
`extended position to the retracted position. The collar translates distally relative to the
`
`case when the needle shroud is in the retracted position and the carrier moves from the
`
`first axial position to the second axial position. The boss disengages the opening and
`
`abuts the case when the carrier is in the second axial position, and the plunger
`
`translates axially relative to the carrier under the force of the drive spring advancing the
`
`carrier from the second axial position to a third axial position relative to the case. The
`
`collar rotates to a third angular position relative to the case and translates with the
`
`needle shroud distally relative to the case when the carrier is in the third axial position.
`
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`The collar rotates to a fourth angular position relative to the case when the needle
`
`shroud is in the locked second extended position. The carrier boss is adapted to abut a
`
`surface in the carrier slot when the collar is in the fourth angular position and the needle
`
`shroud is in the locked second extended position. The engagement of the carrier boss
`
`and the carrier slot notch and the engagement of the carrier to the case substantially
`
`fixes the collar in an axial position relative to the case.
`
`In an exemplary embodiment, the autoinjector further comprises a control spring biasing
`
`the collar relative to the case.
`
`In an exemplary embodiment, the carrier includes a compliant beam adapted to engage
`
`the rib when the carrier is in the first and second axial positions. The needle shroud
`
`includes a ramp adapted to engage and deflect the compliant beam as the needle
`
`shroud translates from the first extended position to the retracted position.
`
`Further scope of applicability of the present invention will become apparent from the
`
`detailed description given hereinafter. However, it should be understood that the
`
`detailed description and specific examples, while indicating preferred embodiments of
`
`the invention, are given by way of illustration only, since various changes and
`
`modifications within the spirit and scope of the invention will become apparent to those
`
`skilled in the art from this detailed description.
`
`Brief Description of the Drawings
`
`The present invention will become more fully understood from the detailed description
`
`given hereinbelow and the accompanying drawings which are given by way of
`
`illustration only, and thus, are not limitive of the present invention, and wherein:
`
`Figure 1A
`
`is a side view of an exemplary embodiment of an autoinjector according
`
`to the present invention prior to use,
`
`Figure 1B
`
`is a side view of an exemplary embodiment of an autoinjector according
`
`to the present invention prior to use,
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`Figure 10
`
`is a longitudinal section of an exemplary embodiment of an autoinjector
`
`according to the present invention prior to use,
`
`Figure 1D
`
`is a longitudinal section of an exemplary embodiment of an autoinjector
`
`according to the present invention prior to use,
`
`Figure 1E
`
`is a longitudinal section of an exemplary embodiment of an autoinjector
`
`according to the present invention prior to use,
`
`Figure 1F
`
`is longitudinal section of an exemplary embodiment of an autoinjector
`
`according to the present invention prior to use,
`
`Figures 2A to 2H
`
`are schematic views of an exemplary embodiment of a control
`
`mechanism for an autoinjector according to the present invention in
`
`various states of operation of the autoinjector,
`
`Figure 3A
`
`is a side view of an exemplary embodiment of an autoinjector according
`
`to the present invention during use,
`
`Figure BB
`
`is a side view of an exemplary embodiment of an autoinjector according
`
`to the present invention during use,
`
`Figure SC
`
`is a longitudinal section of an exemplary embodiment of an autoinjector
`
`according to the present invention during use,
`
`Figure 3D
`
`is a longitudinal section of an exemplary embodiment of an autoinjector
`
`according to the present invention during use,
`
`Figure 3E
`
`is a longitudinal section of an exemplary embodiment of an autoinjector
`
`according to the present invention during use,
`
`Figure 3F
`
`is another longitudinal section of an exemplary embodiment of an
`
`autoinjector according to the present invention during use,
`
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`Figure 4A
`
`is a side view of an exemplary embodiment of an autoinjector according
`
`to the present invention during use,
`
`Figure 4B
`
`is a side view of an exemplary embodiment of an autoinjector according
`
`to the present invention during use,
`
`Figure 4C
`
`is a longitudinal section of an exemplary embodiment of an autoinjector
`
`according to the present invention during use,
`
`Figure 4D
`
`is a longitudinal section of an exemplary embodiment of an autoinjector
`
`according to the present invention during use,
`
`Figure 4E
`
`is a longitudinal section of an exemplary embodiment of an autoinjector
`
`according to the present invention during use,
`
`Figure 4F
`
`is another longitudinal section of an exemplary embodiment of an
`
`autoinjector according to the present invention during use,
`
`Figure 5A
`
`is a side view of an exemplary embodiment of an autoinjector according
`
`to the present invention during use,
`
`Figure 5B
`
`is a side view of an exemplary embodiment of an autoinjector according
`
`to the present invention during use,
`
`Figure 5C
`
`is a longitudinal section of an exemplary embodiment of an autoinjector
`
`according to the present invention during use,
`
`Figure 5D
`
`is a longitudinal section of an exemplary embodiment of an autoinjector
`
`according to the present invention during use,
`
`Figure 5E
`
`is a longitudinal section of an exemplary embodiment of an autoinjector
`
`according to the present invention during use,
`
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`Figure 5F
`
`is another longitudinal section of an exemplary embodiment of an
`
`autoinjector according to the present invention during use,
`
`Figure 6A
`
`is a side view of an exemplary embodiment of an autoinjector according
`
`to the present invention after use,
`
`Figure 6B
`
`is a side view of an exemplary embodiment of an autoinjector according
`
`to the present invention after use,
`
`Figure 60
`
`is a longitudinal section of an exemplary embodiment of an autoinjector
`
`according to the present invention after use,
`
`Figure 6D
`
`is a longitudinal section of an exemplary embodiment of an autoinjector
`
`according to the present invention after use,
`
`Figure 6E
`
`is a longitudinal section of an exemplary embodiment of an autoinjector
`
`according to the present invention after use,
`
`Figure 6F
`
`is another longitudinal section of an exemplary embodiment of an
`
`autoinjector according to the present invention after use,
`
`Figure 7A
`
`is a side view of an exemplary embodiment of an autoinjector according
`
`to the present invention after use,
`
`Figure 7B
`
`is a side view of an exemplary embodiment of an autoinjector according
`
`to the present invention after use,
`
`Figure 70
`
`is a longitudinal section of an exemplary embodiment of an autoinjector
`
`according to the present invention after use,
`
`Figure 7D
`
`is a longitudinal section of an exemplary embodiment of an autoinjector
`
`according to the present invention after use,
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`Figure 7E
`
`is a longitudinal section of an exemplary embodiment of an autoinjector
`
`according to the present invention after use, and
`
`Figure 7F
`
`is another longitudinal section of an exemplary embodiment of an
`
`autoinjector according to the present invention after use.
`
`Corresponding parts are marked with the same reference symbols in all figures.
`
`Detailed Description
`
`Figures 1A and 1B are different side views of an exemplary embodiment of an
`
`autoinjector 1 according to the present invention. The autoinjector 1 comprises a case
`
`2 including a front case 2.1 and a rear case 2.2, and a needle shroud 7 telescoped
`
`within the case 2. A removable cap 11 is attached at a distal end of the case 2. The
`
`case 2 may comprise a viewing window 2.7, which may be a cut-out or transparent
`
`portion of the front case 2.1. Figure 1C is a related longitudinal section of the
`
`autoinjector 1 with the case 2 and the needle shroud 7 removed for clarity. Figure 1D is
`
`a related longitudinal section of the autoinjector 1 with the case 2 removed for clarity.
`
`Figure 1E is a related longitudinal section of the autoinjector 1. Figure 1F is another
`
`related longitudinal section of the autoinjector 1.
`
`As shown in Figures 1E and 1F, the case 2 is adapted to slidably retain carrier which
`
`holds a medicament container, such as a syringe 3. The carrier, shown in a first axial
`
`position relative to the case 2, may include a syringe carrier (8) which is adapted to hold
`
`the syringe 3 (e.g., a pre-filled syringe having a needle 4 arranged at a distal end).
`
`When the autoinjector 1 and/or the syringe 3 are assembled, a protective needle sheath
`
`5 may be removably coupled to the needle 4. The cap 11 may include an element (e.g.,
`
`a barb, a hook, a narrowed section, etc.) arranged to engage the protective needle
`
`sheath 5 such that the protective needle sheath 5 is removed as the cap 11 is removed
`
`from the case 2. A stopper 6 is arranged for sealing the syringe 3 proximally and for
`
`displacing a medicament M contained in the syringe 3 through the needle 4.
`
`In other
`
`exemplary embodiments, the medicament container may be a cartridge which includes
`
`the medicament M and engages a removable needle.
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`In an exemplary embodiment, the needle shroud 7 is telescoped in the distal end of the
`
`case 2. A control spring 9 is arranged to bias the needle shroud 7 in a distal direction D
`
`relative to the case 2.
`
`In an exemplary embodiment, a drive spring 10 (which may be a compression spring) is
`
`arranged within a proximal part 8.1 of the syringe carrier 8. A plunger 12 serves for
`
`forwarding a force of the drive spring 10 to the stopper 6.
`
`In an exemplary embodiment,
`
`the plunger 12 is hollow and telescoped within the proximal part 8.1 ofthe syringe
`
`carrier 8 wherein the drive spring 10 is arranged within the plunger 12 biasing the
`
`plunger 12 in the distal direction D relative to the syringe carrier 8.
`
`In an exemplary
`
`embodiment, the proximal part 8.1 of the syringe carrier 8 protrudes through an opening
`
`in a proximal end of the case 2 and serves as a trigger button 13.
`
`In other exemplary
`
`embodiments, a button overmold may be coupled to or integrally formed with the trigger
`
`button 13.
`
`In an exemplary embodiment, a button lock mechanism 14 is arranged for locking the
`
`trigger button 13 such that it cannot be operated prior to depression of the needle
`
`shroud 7 and for unlocking the trigger button 13 on depression of the needle shroud 7
`
`thus allowing operation of the trigger button 13. The button lock mechanism 14
`
`comprises one or more compliant first beams 8.2 on the syringe carrier 8 adapted to
`
`abut ribs 2.3 within the case 2. This abutment prevents travel of the syringe carrier 8 in
`
`the distal direction D relative to the case 2. Furthermore, the button lock mechanism 14
`
`comprises one or more ramp features 7.1 on a proximal end of the needle shroud 7
`
`adapted to abut and radially inwardly deflect the compliant first beams 8.2 when the
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`needle shroud 7 is depressed.
`
`In an exemplary embodiment, a plunger release mechanism 15 is arranged for
`
`preventing release of the plunger 12 prior to the needle 4 reaching an insertion depth
`
`and for releasing the plunger 12 once the needle 4 reaches its insertion depth. The
`
`30
`
`plunger release mechanism 15 comprises: one or more compliant second beams 8.3
`
`with a respective first boss 8.4 arranged on the syringe carrier 8, a respective first
`
`opening 12.1 (best seen in figure 6F) radially arranged in the plunger 12 for engaging
`
`the first boss 8.4, a proximal narrow section 2.4 of the case 2 adapted to radially
`
`outwardly support the first boss 8.4 such that it cannot disengage the first opening 12.1
`
`

`

`when the syringe carrier 8 is in a proximal position relative to the case 2, a wide section
`
`2.5 distal of the narrow section 2.4 in the case 2 adapted to accommodate the first boss
`
`8.4 upon radial outward deflection of the second beams 8.3 once the wide section 2.5 is
`
`axially aligned with the first boss 8.4 when the trigger button 13 has been pressed. At
`
`least one of the first boss 8.4 and the first opening 12.1 may be ramped to reduce the
`
`force necessary to deflect the second beam 8.3 under the load of the drive spring 10.
`
`In an exemplary embodiment, a control mechanism 21 (illustratively shown in figures 2A
`
`to 2H) is arranged for selectively applying the force of the control spring 9 to the syringe
`
`carrier 8 or to the needle shroud 7. The control mechanism 21 comprises a collar 16
`
`having a shroud boss 18 adapted to engage a shroud slot 17 in the needle shroud 17
`
`and a carrier boss 20 adapted to engage a carrier slot 19 in the syringe carrier 8.
`
`In an
`
`exemplary embodiment, the shroud boss 18 is disposed on an outer surface of the
`
`collar 16 and in a first plane angled with respect to a transverse axis of the collar 16,
`
`and the carrier boss 20 is disposed on an inner surface of the collar 16 in an axial plane,
`
`perpendicular to the transverse axis of the collar 16.
`
`The control spring 9 is proximally grounded in the case 2 and distally bearing against
`
`the collar 16 which is movable axially and rotationally with respect to the case 2.
`
`In an
`
`exemplary embodiment, the collar 16 is arranged within the needle shroud 7 and over
`
`the syringe carrier 8. Prior to use, the control spring 9 may be compressed between the
`
`case 2 and the collar 16.
`
`Figures 2A to 2H are schematic views of an exemplary embodiment of the control
`
`mechanism 21 different states corresponding to operation of the autoinjector 1.
`
`In an
`
`exemplary embodiment, the shroud slot 17 comprises an angled first surface 17.1, a
`
`transversal second surface 17.2, a longitudinal third surface 17.3, a transversal fourth
`
`surface 17.4, an angled fifth surface 17.5 and a transversal sixth surface 17.6.
`
`In an
`
`exemplary embodiment, the carrier slot 19 comprises a transversal first surface 19.1, a
`
`longitudinal second surface 19.2, an angled third surface 19.3, a longitudinal fourth
`
`surface 19.4, a transversal fifth surface 19.5 and a transversal sixth surface 19.6.
`
`A sequence of operation of the autoinjector 1 is as follows:
`
`10
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`30
`
`

`

`10
`
`Prior to use, the autoinjector 1
`
`is in the state as illustrated in figures 1A to 1F.
`
`If
`
`applicable, the autoinjector 1 may be removed from a packaging. The medicament M
`
`may be examined visually through the viewing window 2.7. The cap 11 can be removed
`
`by pulling it in the distal direction D away from the case 2 thereby also removing the
`
`protective needle sheath 5. The needle shroud 7 is in a first extended position FEP
`
`protruding distally beyond a distal end of the case 2.
`
`Prior to use, the syringe carrier 8 is axially locked to the case 2, because the compliant
`
`first beams 8.2 on the syringe carrier 8 abut the ribs 2.3 within the case 2. The carrier
`
`boss 20 abuts the transversal first surface 19.1 of the carrier slot 19, preventing axial
`
`movement of the collar 16 in the distal direction D, and abuts the longitudinal second
`
`surface 19.2, preventing the collar 16 from rotating in a first rotational direction R
`
`relative to the case 2 (cf. fig. 2A). The shroud boss 18 is located between the angled
`
`first surface 17.1 and the transversal second surface 17.2. The first extended position
`
`FEP is defined by the shroud boss 18 abutting the angled first surface 17.1 of the
`
`shroud slot 17.
`
`Figures 3A—F show an exemplary embodiment of the autoinjector1 during use. Figures
`
`3A and 3B are different side views of an exemplary embodiment of the autoinjector 1
`
`after removal of the cap 11 and protective needle sheath 5, and after the needle shroud
`
`7 has been moved into a retracted position RP relative to the case 2. Figure 30 is a
`
`related longitudinal section of the autoinjector 1 with the case 2 and needle shroud 7
`
`removed for clarity. Figure 3D is a related longitudinal section of the autoinjector 1 with
`
`the case 2 removed for clarity. Figure 3E is a related longitudinal section of the
`
`autoinjector 1. Figure 3F is another related longitudinal section of the autoinjector 1.
`
`When the autoinjector 1
`
`is placed on and pressed against an injection site, the needle
`
`shroud 7 translates from the first extended position FEP to a retracted position RP
`
`relative to the case 2 against the biasing force of the control spring 9. As the needle
`
`shroud 7 translates from the first extended position FEP to the retracted position RP,
`
`the engagement of the shroud boss 18 and the angled first surface 17.1 pushes the
`
`collar 16 in the proximal direction P. As the first surface 17.1 is angled, a rotational
`
`force in the first rotational direction R is applied to the collar 16 as it translates in the
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`10
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`

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`11
`
`proximal direction P, but the abutment of the carrier boss 20 on the longitudinal second
`
`surface 19.2 prevents the collar 16 from rotating relative to the case 2 (cf. fig. 28).
`
`Also, as the needle shroud 7 translates from the first extended position FEP to the
`
`retracted position RP, the ramp features 7.1 of the needle shroud 7 engage the
`
`compliant first beams 8.2, causing them to deflect radially inward. When the needle
`
`shroud 7 is in the retracted position RP, the compliant first beams 8.2 are deflected
`
`radially due to the presence of the ramp features 7.1 on the needle shroud 7, but the
`
`compliant first beams 8.2 maintain engagement with the ribs 2.3. This prevents the
`
`10
`
`syringe carrier 8 from translating relative to the case 2 until the trigger button 13 is
`
`pressed.
`
`If the autoinjector 1 were removed from the injection site, the collar 16 and the needle
`
`shroud 7 would return to the positions shown in figures 1A to 1F under the biasing force
`
`15
`
`of the control spring 9.
`
`20
`
`25
`
`30
`
`Figures 4A—F show an exemplary embodiment of the autoinjector 1 during use.
`
`Figures 4A and 4B are different side views of the autoinjector 1 after depression of
`
`the trigger button 13. Figure 4C is a related longitudinal section of the autoinjector 1
`
`with the case 2 and the needle shroud 7 removed for clarity. Figure 4D is a related
`
`longitudinal section of the autoinjector 1 with the case 2 removed for clarity. Figure
`
`4E is a related longitudinal section of the autoinjector 1. Figure 4F is another related
`
`longitudinal section of the autoinjector 1.
`
`When the trigger button 13 is pressed, the compliant first beams 8.2 disengage the
`
`ribs 2.3, and the syringe carrier 8 moves in the distal direction D relative to the case
`
`2. The carrier boss 20 disengages the longitudinal second surface 19.2 of the carrier
`
`slot 19 (cf. fig. 20) such that the rotational force on the shroud boss 18 by the angled
`
`first surface 17.1 causes the collar 16 to rotate in the first rotational direction R until it
`
`abuts the longitudinal third surface 17.3. When the shroud boss 18 abuts the
`
`longitudinal third surface 17.3, the carrier boss 20 has rotated into engagement with
`
`the angled third surface 19.3 of the carrier slot 19 (cf. fig. 2D). The force of the
`
`control spring 9 is now applied to the syringe carrier 8.
`
`

`

`12
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`Figures 5A—F show an exemplary embodiment of the autoinjector1 during use.
`
`Figures 5A and 5B are different side views of the autoinjector 1 with the needle 4
`
`extending from the case 2. Figure SC is a related longitudinal section of the
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`autoinjector 1 with the case 2 and needle shroud removed for clarity. Figure 5D is a
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`related longitudinal section of the autoinjector 1 with the case 2 removed for clarity.
`
`Figure 5E is a related longitudinal section of the autoinjector 1. Figure 5F is another
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`related longitudinal section of the autoinjector 1.
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`When the shroud boss 18 abuts the longitudinal third surface 17.3 and the carrier
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`boss 20 abuts the angled third surface 19.3, the force of the control spring 9 pushes
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`the syringe carrier 8 in the distal direction D relative to the case 2 until the syringe
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`carrier 8 abuts a front stop 2.8 on the case 2. The shroud boss 18 abuts transversal
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`fourth surface 17.4 of the shroud slot 17 (cf. fig. 2E). This axial translation of the
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`syringe carrier 8 results in insertion of the needle 4 into the injection site.
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`As the syringe carrier 8 translates under the force of the control spring 9, the
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`compliant second beams 8.3 reach the wide section 2.5 of the case 2, such that the
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`plunger 12, under load from the drive spring 10, deflects the first boss 8.4 on the
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`compliant beam 8.3 radially outwards. The first boss 8.4 disengages the first opening
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`12.1 in the plunger 12, and the plunger 12 is released from the syringe carrier 8,
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`advancing the stopper 6 within the syringe 3 and ejecting the medicament M through
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`the needle 4.
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`In an exemplary embodiment, release of the plunger 12 from the
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`syringe carrier 8 may provide an audible and/or tactile feedback to indicate that the
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`injection has started. Progress of the medicament delivery can be observed through
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`the viewing window 2.7 by examining movement of the plunger 12. Visibility of the
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`plunger 12 in the viewing window 2.7 may also help differentiate between a used
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`autoinjector and an unused autoinjector.
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`After the syringe carrier 8 has abutted the front stop 2.8 and ceased axial translation
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`relative to the case 2, the force of the control spring 9 pushes the collar 16 in the
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`distal direction D, and a rotational force is applied to the carrier boss 20 by the angled
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`third surface 19.3 (cf. fig. 2F) of the carrier slot 19. Because the shroud boss 18
`
`abuts the transversal fourth surface 17.4, it is no longer rotationally supported by the
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`longitudinal third surface 17.3, allowing the collar 16 to rotate in the first rotational
`
`10
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`15
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`20
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`25
`
`3O
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`

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`13
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`direction R. The collar 16 rotates in the first rotational direction R until the carrier
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`boss 20 abuts the longitudinal fourth surface 19.4, and the shroud boss 18 abuts the
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`angled fifth surface 17.5. Because the autoinjector1 is being held in place on the
`
`injection site, the collar 16 remains in the position shown in figure 2F.
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`Figures 6A-F show an exemplary embodiment of the autoinjector 1 after use. Figures
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`6A and 6B are different side views of the autoinjector 1 with the syringe 3 emptied.
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`Figure 6C is a related longitudinal section of the autoinjector 1 with the case 2 and
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`needle shroud removed for clarity. Figure 6D is a related longitudinal section of the
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`autoinjector 1 with the case 2 removed for clarity. Figure 6E is a related longitudinal
`
`section of the autoinjector 1. Figure 6F is another related longitudinal section of the
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`autoinjector 1.
`
`As shown in Figures 6A-F, when the autoinjector 1
`
`is removed from the injection site,
`
`the needle shroud 7 translates relative to the case 2 from the retracted position RP
`
`toward a second extended position SEP.
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`Figures 7A—F show an exemplary embodiment of the autoinjector after use. Figures
`
`7A and 7B are different side views of the autoinjector 1 removed from the injection
`
`site with the needle shroud 7 in the second extended position. Figure 7C is a related
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`longitudinal section of the autoinjector 1 with the case 2 and needle shroud removed
`
`for clarity. Figure 7D is a related longitudinal section of the autoinjector 1 with the
`
`case 2 removed for clarity. Figure 7E is a related longitudinal section of the
`
`autoinjector 1. Figure 7F is another related longitudinal section of the autoinjector 1.
`
`10
`
`15
`
`20
`
`25
`
`When the autoinjector 1
`
`is removed from the injection site, the force of the control
`
`spring 9 pushes the collar 16 in the distal direction D. Because the carrier boss 20 is
`
`abutting the longitudinal fourth surface 19.4 (and prevents the collar 16 from rotating),
`
`the force of the control spring 9 is applied by the shroud boss 18 on the angled fifth
`
`3O
`
`surface 17.5 to advance the needle shroud 7 in the distal direction D relative to the
`
`case 2 until the carrier boss 20 disengages the longitudinal fourth surface 19.4 (cf.
`
`fig. 2G). A rotational force applied on the shroud boss 18 by the angled fifth surface
`
`17.5 causes the collar 16 to rotate in the first rotational direction R, until the shroud
`
`boss 18 abuts the transversal sixth surface 17.6. The needle shroud 7 is now in a
`
`

`

`14
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`second extended position SEP (distal of the first extended position FEP) relative to
`
`the case 2. The needle shroud 7 is locked in the second extended position SEP,
`
`because if there is an attempt to move the needle shroud 7 proximally, the
`
`transversal sixth surface 17.6 will push the collar 16 in the proximal direction, but the
`
`carrier boss 20 will abut the transversal sixth surface 19.6 of the carrier slot 19 (cf.
`
`fig. 2H). Because the syringe carrier 8 cannot move in the proximal direction P
`
`relative to the case 2 (because the first boss 8.4 abuts the narrow section 2.4 of the
`
`case 2), the collar 16 prevents the needle shroud 7 from retracting.
`
`10
`
`In another exemplary embodiment, the shroud boss 18 could be arranged on the
`
`needle shroud 7 and engaged in the shroud slot 17, which would be arranged in the
`
`collar 16. Likewise the carrier boss 20 could be arranged on the syringe carrier 8 and
`
`engaged in the carrier slot 19, which would be arranged in the collar 16.
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`

`

`15
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`The term “drug” or “medicament“, as used herein, means a pharmaceutical
`
`formulation containing at least one pharmaceutically active compound,
`
`wherein in one embodiment the pharmaceutically active compound has a molecular
`
`weight up to 1500 Da and/or is a peptide, a proteine, a polysaccharide, a vaccine, a
`
`DNA, a RNA, an enzyme, an antibody or a fragment thereof, a hormone or an
`
`oligonucleotide, or a mixture of the above-mentioned pharmaceutically active compound,
`
`wherein in a further embodiment the pharmaceutically active compound is useful for the
`
`treatment and/or prophylaxis of diabetes mellitus or complications associated with
`
`diabetes mellitus such as diabetic retinopathy, thromboembolism disorders such as
`
`deep vein or pulmonary thromboembolism, acute coronary syndrome (ACS), angina,
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`myocardial infarction, cancer, macular degeneration, inflammation, hay fever,
`
`atherosclerosis and/or rheumatoid arthritis,
`
`wherein in a further embodiment the pharmaceutically active compound comprises at
`
`least one peptide for the treatment and/or prophylaxis of diabetes mellitus or
`
`complications associated with diabetes mellitus such as diabetic retinopathy,
`
`wherein in a further embodiment the pharmaceutically active compound comprises at
`
`least one human insulin or a human insulin analogue or derivative, glucagon-like
`
`peptide (GLP-1) or an analogue or derivative thereof, or exendin-3 or exendin-4 or an
`
`analogue or derivative of exendin-3 or exendin-4.
`
`Insulin analogues are for example Gly(A21), Arg(831), Arg(832) human insulin; Lys(BS),
`
`Glu(829) hu