NZ614081B2

NZ614081B2 - Auto-injector

Info

Publication number: NZ614081B2
Application number: NZ614081A
Authority: NZ
Inventors: Simon Francis Brereton; Rosie Burnell; Matthew Ekman; Thomas Kemp
Original assignee: Sanofiaventis Deutschland GMBH
Priority date: 2011-02-18
Filing date: 2012-02-16
Publication date: 2015-03-03

Abstract

auto-injector (1) for administering a dose of a liquid medicament (M) is disclosed. After the liquid medicament has been injected the injection needle is automatically retracted. The auto-injector has a tubular chassis (2) telescopable in a tubular case (12) and a carrier subassembly comprising a tubular carrier (7) slidably arranged relative to the chassis (2) inside the case (12). The carrier (7) is adapted to contain a syringe (3) with a hollow injection needle (4), a drive spring (8) and a plunger (9) for forwarding load of the drive spring (8) to a stopper (6) of the syringe (3). The syringe (3) is lockable for joint axial translation with the carrier (7). A trigger button (13) is arranged distally or laterally in or on the case (12). A control spring (19) is arranged around the carrier (7) with a needle extension control mechanism (24) for coupling a proximal end of the control spring (19) to either the carrier (7) for advancing it for needle extension or to the chassis (2) for needle retraction depending on the relative axial position of the carrier (7) and the chassis (2). A plunger release mechanism (27) is arranged for releasing the plunger (9) for injection when the carrier (7) has at least almost reached an extended proximal position. Adetent mechanism (18) is arranged for coupling the chassis (2) to the carrier (7) for joint axial translation relative to the case (12), wherein the detent mechanism (18) decouples the chassis (2) from the carrier (7) upon actuation of the trigger button (13) thus allowing the carrier (7) to move relative to the chassis (2) so as to cause the needle extension control mechanism (24) to switch the proximal end of the control spring (19) to the carrier (7) for needle extension. A syringe retraction control mechanism (25) is arranged for coupling a distal end of the control spring (19) to either the carrier (7) for needle retraction or to the case (12) otherwise. tubular carrier (7) slidably arranged relative to the chassis (2) inside the case (12). The carrier (7) is adapted to contain a syringe (3) with a hollow injection needle (4), a drive spring (8) and a plunger (9) for forwarding load of the drive spring (8) to a stopper (6) of the syringe (3). The syringe (3) is lockable for joint axial translation with the carrier (7). A trigger button (13) is arranged distally or laterally in or on the case (12). A control spring (19) is arranged around the carrier (7) with a needle extension control mechanism (24) for coupling a proximal end of the control spring (19) to either the carrier (7) for advancing it for needle extension or to the chassis (2) for needle retraction depending on the relative axial position of the carrier (7) and the chassis (2). A plunger release mechanism (27) is arranged for releasing the plunger (9) for injection when the carrier (7) has at least almost reached an extended proximal position. Adetent mechanism (18) is arranged for coupling the chassis (2) to the carrier (7) for joint axial translation relative to the case (12), wherein the detent mechanism (18) decouples the chassis (2) from the carrier (7) upon actuation of the trigger button (13) thus allowing the carrier (7) to move relative to the chassis (2) so as to cause the needle extension control mechanism (24) to switch the proximal end of the control spring (19) to the carrier (7) for needle extension. A syringe retraction control mechanism (25) is arranged for coupling a distal end of the control spring (19) to either the carrier (7) for needle retraction or to the case (12) otherwise.

Description

Auto-injector Technical Field The invention relates to an auto-injector for administering a dose of a liquid medicament according to the preamble of claim 1.

Background of the ion Administering an ion is a process which presents a number of risks and nges for users and healthcare professionals, both mental and physical.

Injection devices (Le. devices capable of delivering medicaments from a medication container) typically fali into two categories —— manual devices and njectors. in a manual device — the user must provide the mechanical energy to drive the fluid through the . This is typically done by some form of button / plunger that has to be continuously pressed by the user during the injection. There are numerous disadvantages to the user from this approach. If the user stops pressing the button / plunger then the injection will also stop. This means that the user can deliver an ose if the device is not used properly (Le. the plunger is not fully pressed to its end on). Injection forces may be too high for the user, in particular if the patient is elderly or has dexterity problems.

The extension of the button/plunger may be too great. Thus it can be inconvenient for the user to reach a fully extended button. The combination of injection force and button extension can cause trembling / shaking of the hand which in turn increases discomfort as the inserted needle moves.

Auto—injector devices aim to make dministration of injected therapies easier for patients. Current therapies delivered by means of self-administered injections include drugs for diabetes (both insulin and newer GLP-1 class drugs), migraine, hormone therapies, anticoagulants etc.

Auto-injectors are devices which completely or partially replace activities involved in parenteral drug delivery from standard syringes. These activities may include removal of a protective syringe cap, insertion of a needle into a patient’s skin, injection of the medicament, removal of the needle, shielding of the needle and preventing reuse of the . This overcomes many of the disadvantages of manual devices. injection forces I button extension, hand-shaking and the likelihood of ring an incomplete dose are reduced. Triggering may be performed by numerous means. for example a trigger button or the action of the needle reaching its injection depth. In some devices the energy to deliver the fluid is provided by a spring.

US 2002/0095iZO A1 discloses an automatic injection device which automatically s a pre-measured quantity of fluid medicine when a tension spring is released. The tension spring moves an ampoule and the injection needle from a storage position to a deployed position when it is released. The content of the ampoule is thereafter expelled by the tension spring forcing a piston forward inside the e. After the fluid medicine has been ed, torsion stored in the tension spring is released and the ion needle is automatically retracted back to its al storage on.

High viscosity ments require high forces for expelling them through the relatively thin injection needle. To achieve these forces strong drive springs are needed. This can lead to a high impact felt by the user when inserting the needle into the skin and to high forces felt by the user when triggering the ion.

Summary of the Invention 3O It is an object of the t invention to provide an improved auto-injector and an improved method for operating an auto-injector, or to at least provide the public with a useful choice.

The object is ed by an auto—injector according to claim 1 and by a method according to claim 13.

Preferred embodiments of the ion are given in the dependent claims. in the context of this specification the term proximal refers to the direction pointing s the t during an injection while the term distal refers to the opposite direction pointing away from the patient. The term s refers to a radial ion pointing towards a longitudinal axis of the auto-injector whereas the term outwards refers to the opposite direction iy pointing away from the longitudinal axis.

According to the invention an njector for administering a dose of a liquid medicament comprises: - a tubular chassis telescopable in a tubular case, - a carrier subassembly comprising a tubular carrier slidably arranged relative to the chassis inside the case, the carrier adapted to contain a syringe with a hollow injection needle, a drive spring and a plunger for forwarding load of the drive spring to a stopper of the syringe, wherein the syringe is iockabie nt axial translation with the carrier, - a trigger button arranged distally or laterally in or on the case, - a control spring arranged around the carrier, - a needle extension control mechanism for coupling a proximal end of the l spring to either the carrier for advancing it for needie extension or to the chassis for needle retraction depending on the relative axial position of the carrier and the chassis, ~ a plunger release mechanism arranged for releasing the plunger for expelling the medicament when the carrier has at least almost reached 3 extended proximal on, — a detent mechanism arranged for coupling the chassis to the carrier for joint axial translation relative to the case, wherein the detent ism is arranged to le the chassis from the carrier upon actuation of the trigger button thus allowing the carrier to move relative to the chassis so as to cause the needle extension control mechanism to switch the proximal end of the control spring to the r for needle extension, ~ a syringe retraction l mechanism arranged for coupling a distal end of the 3O control spring to either the carrier for needle retraction or to the case otherwise.

According to the invention, there is also provided a method of operating an auto~injector, the auto-injector comprising: a tubular chassis teiescopable in a tubular case, a carrier subassembly comprising a tubular carrier slidably arranged relative to the chassis inside the case, the carrier adapted to contain a syringe with a hollow injection needle, a drive spring and a plunger for forwarding load of the drive spring to a r of the syringe. wherein the syringe is lockable forjoint axial ation with the r, a trigger button arranged distally or laterally in or on the case, a control spring ed around the r, a needle extension control mechanism for ng a proximal end of the control spring to either the carrier or to the chassis, a r release mechanism arranged for locking the drive spring, a detent mechanism ed for ng the chassis to the carrier, a syringe retraction control mechanism arranged for coupling a distal end of the control spring to either the carrier or to the case, the method sing the steps of: coupling the proximai end of the control spring to the carrier by the needle extension control mechanism, preventing release of the drive spring by the plunger release “IO mechanism, preventing decoupling of the chassis from the carrier by the detent ism and coupling the distal end of the control spring to the case by the syringe retraction control mechanism in an initial state, translating the case in the proximal ion relative to the chassis against the force of the control spring unlocking the detent mechanism when the case is translated into an advanced position thereby allowing translation of the carrier relative to the chassis translating the carrier in the proximal direction thereby switching the needle extension control mechanism so as to decouple the proximal end of the control spring from the chassis and couple it to the r, thereby releasing the control spring for advancing the carrier for needle extension, releasing the drive spring by the plunger release mechanism when the needle at least almost reaches an extended proximal position thereby allowing the drive spring to advance the plunger and the stopper for at least partially expelling the medicament, translating the case in the distal ion under load of the control spring relative to the carrier ling the proximal end of the control spring from the carrier and coupling it to the chassis by the needle extension control mechanism and decoupling the distal end of the l spring from the case and coupling it to the carrier by the syringe retraction control mechanism when the case reaches a defined on relative to the carrier during translation in the distal direction, retracting the carrier subassembly into the chassis into a needle safe position under load of the control spring. 3O Comprises/comprising and grammatical variations f when used in this specification are to be taken to specify the presence of stated features, integers, steps or components or groups thereof, but do not preclude the presence or addition of one or more other features, integers, steps, components or groups thereof.

The carrier subassembly with the integrated drive spring allows for employing a strong drive spring without any impact on the user when triggering the auto—injector or during needle extension since these actions are achieved or opposed by the control spring which can be specified considerably weaker than the drive spring. This allows for delivering highly viscous medicaments.

There are a number of significant benefits of ting the ons between the drive spring and the control spring in this way. The auto—injector is always needle safe, i.e. the needle can be retracted before the injection is complete. The reliability of the auto- injector is improved as the ents for needle advance and retraction are not loaded by the high impact of a freely expanding high force drive spring. The auto~injector is well suited to serve as a platform as the drive spring can be swapped to deliver different viscosity drugs without affecting the ion or retraction functions. This is particularly advantageous for high viscosity fluids.

Releasing the drive spring upon the needle reaching an advanced proximal position, eg. when the needle is advanced to a corresponding ion depth, avoids a so called wet injection, i.e. medicament leaking out of the needle which is a problem in conventional art auto-injectors, where both needle extension and injection are achieved by pushing on the r. The njector according to the invention solves the wet injection problem by the separate springs for translation of the carrier and for drug delivery.

The auto~injector according to the invention has a particularly low part count compared to most conventional auto-injectors thus reducing manufacturing costs. The arrangement with te control spring and drive spring for fluid injection allows for using one design for different viscosity liquids byjust changing the drive spring, and for different volumes just by changing the length of the plunger. This is an advantage over conventional art s where the main spring also powers needle extension and/or retraction. in the context of this specification the chassis is generally considered as being fixed in position so motion of other ents is described relative to the s. in an initial as delivered state of the auto-injector the proximal end of the control spring is coupled to the chassis by the needle extension control mechanism while the distal end is coupled to the case by the syringe retraction control mechanism, release of the drive spring is prevented by the plunger release mechanism, decoupling of the chassis from the r is prevented by the detent mechanism.

In order to trigger the njector the case has to be translated in the proximal direction relative to the chassis against the force of the control spring. When the case has at least almost reached an advanced proximal position the detent mechanism is unlocked thereby allowing translation of the carrier relative to the chassis. Preferably this position has been reached, when the case has moved 85%-98% of its total proximal extension. The relative translation of the case and the chassis could be achieved, eg. by fixing the chassis and moving the case. For the purpose of injection, e.g., the chassis may be fixed by ng against an injection site, eg. a t's skin. Hence a user, eg. the patient or a caregiver, could grab the case with their whole hand and push the chassis protruding from the proximal end against the injection site, thereby translating the case relative to the chassis in proximal direction and triggering the auto-injector in a way described above.

The carrier now is unlocked to be translated in the proximal direction. As the carrier translates in the proximal direction relative to the case and to the chassis it thereby switches the needle extension l mechanism depending on the relative position of the carrier in the chassis so as to decouple the al end of the control spring from the chassis and couple it to the carrier, thereby releasing the control spring for advancing the r for needle extension. For the purpose of injection, e.g., the user could ly depress a r button coupled to the carrier forcing the carrier in the proximal direction. This would cause the needle to be extended according to the needle extension control mechanism described before. Again, for purpose of injection, the user pushing the or against an injection site could press the trigger button thereby translating the carrier in the proximal ion relative to the case and the chassis thereby switching the needle extension control mechanism as described before.

Advancing the carrier under the force of the control spring would then result in advancing the needle into the skin.

Alternatively the control spring could lly be coupled to the carrier by the needle 1O extension control mechanism so that the r would be immediately advanced when the detent ism is unlocked by translation of the case into the advanced position.

As the needle translates with the r subassembiy to an extended proximal position, where it is no longer needle safe, the drive spring is released by the plunger release mechanism thereby allowing the drive spring to advance the plunger and the stopper for at least partially expelling the ment. This release of the drive spring is preferably triggered by the carrier reaching a predefined relative position within the case. This position is reached, when the carrier has at least almost reached the ed proximal position. Preferably, this position is at 85% to 98% proximal extension. if, for example, the extension length is ‘1 cm the position would fall into the range of 8,5mm — 9,8mm proximal extension length For the e of injection the extended proximal position may correspond to an intended injection depth. Hence the drive spring could be released by the plunger release mechanism once the injection depth is substantially d thereby allowing the drive spring to advance the plunger and the stopper for at least partially delivering the medicament.

If the auto-injector is removed from the injection site after the stopper has bottomed out in the syringe or at any point during injection, the case is translated in the distal direction 3O under load of the l spring relative to the carrier subassembiy.

The needle retraction is triggered by moving the case in distal direction relative to the chassis and the carrier under the force of the control spring. As the case s a defined position relative to the carrier the proximal end of the control spring is decoupled from the carrier and d to the s by the needle extension control mechanism. Furthermore the distal end of the control spring is decoupled from the r sleeve and coupled to the carrier by the syringe retraction control mechanism.

The sequencing of this switching is critical as tion will fail if both collars are attached to the carrier at the same time. This is overcome by separating the switching of the collars by a significant displacement of the case, which es for first switching the needle extension control mechanism and then the syringe tion control mechanism, e.g.

As the control spring now pushes against the chassis in the proximal direction and against the carrier in the distal direction the r subassembly is retracted into the chassis into a needle safe position by the control spring, where the proximai end of the needle is covered. As this retraction is triggered by the relative position between case, chassis, and carrier, it is particularly independent from ing the medicament. For the purpose of injection this position of the case relative to the carrier could be reached, eg. if the auto-injector is removed from the injection site. When,e.g., the user still grabbing the case with their whole hand and g the chassis protruding from the proximal end against the injection site move their hand in distal direction, the case will be moved in distal direction relative to the carrier and the chassis and the mechanism will be triggered as described before. The needle will thus be retracted from the injection site under the force of the control spring. ing to one embodiment the needle extension control ism may comprise a first collar biased by the control spring in the proximal direction, wherein at ieast one resilient beam is proximally arranged on the first collar, wherein respective recesses are arranged in the carrier and case, wherein a transversal extension of a head of the resilient beam is wider than a gap n the carrier and the chassis causing the head of the resilient beam to abut a distal face on the recess in the chassis while being ted from deflecting in an inward direction by the carrier or to abut a distal face on the recess in the r while being prevented from deflecting in an outward direction by the chassis thereby ding load from the control spring to the carrier for needle extension, wherein the resilient beam is ed to be switched between the chassis and the carrier by ramped engagement of the head to the distal faces under load of the control spring ing on the relative longitudinal position between the chassis and the carrier. As the head of the resilient beam may be inwardly and outwardly ramped it may be referred to as an arrowhead.

The plunger release mechanism may comprise at least one resilient arm on the carrier 1O arranged to be in a ramped engagement to the plunger so as to disengage them under load of the drive spring, n a peg protrudes from a distal end face of the trigger button in the proximal direction in a manner to support the resilient arm ting disengagement of the carrier from the plunger and thus e of the drive spring when the r is in a distal on. The trigger button is arranged to remain in position relative to the case when the carrier is translated for advancing the needle. That means, the trigger button, initially coupled to the carrier, pushes the carrier in the proximal direction when sed. As soon as the control spring takes over further ing the carrier the trigger button may abut the case and decouple from the carrier, staying in position as the carrier moves on. Hence the resilient arm is pulled away from the peg thus ailowing tion otthe resilient arm due to the ramped engagement under load of the drive spring for disengaging the plunger from the carrier and releasing the drive spring for drug delivery when the carrier has reached a predefined position during needle advancement.

The detent ism may be arranged to provide a resistive force which has to be overcome to advance the carrier in the proximal direction for needle extension. The carrier may be coupled to a trigger button and the force pushing the trigger button has to exceed the resistive force of the detent mechanism. E.g., once the user applies a force on the trigger button which exceeds a pre—determined value the detent mechanism releases, initiating the injection cycle. if the pre—determined value is not overcome the detent mechanism pushes the carrier and trigger button back into their prior position.

This ensures that the auto-injector is always in a defined state, either triggered or not triggered, not half triggered by the user hesitating.

The detent ism may also be ed to provide a resistive force resisting translation of the carrier in the distal direction ve to the chassis for keeping the carrier in a defined position in a transitional state with both ends of the control spring decoupled from the carrier. This transitional state may be required for retracting the needle on removal from the injection site. As the carrier is biased against the injection site by the control spring before removal from the injection site it has to be led from the al end ofthe l spring and coupled to the distal end for retraction.

The sequencing of this ing is critical as tion will fail if both ends of the control spring are attached to the carrier at the same time. This is overcome by separating the switching of the ends by a significant displacement of the case, which moves in the distal direction ve to the chassis on removal of the injection site under ’15 load of the control spring. As the switching of the distal end of the control spring to the carrier depends on the relative position of the case to the carrier the carrier has to be fixed in the transitional state which is achieved by the detent mechanism.

In one embodiment the detent mechanism comprises a resilient beam on the chassis and a rhomboid ramp member on the carrier, the resilient beam being essentially straight when d and having a first beam head arranged to interact in a ramped engagement with a proximal fourth ramp or a distal fifth ramp on the rhomboid ramp member in such a manner that application of a translative force on the carrier relative to the chassis in the al direction with the first beam head engaged to the fourth ramp deflects the resilient beam in one transversal direction, e.g. outwards when a predetermined value of the translative force, at least ing on the resilience of the resiiient beam, is overcome so as to allow the first beam head to travel along one transversal side of the rhomboid ramp member on continued relative translation of the components. The beam head may protrude transversally from the resilient beam in a mannerto distort the resilient beam by lever action when pushed against the rhomboid ramp memberthereby also defining the predetermined value of the translative force to be overcome by the carrier. Furthermore, the contacting faces of the first beam head and the rhomboid ramp member may have their friction adapted to define the required force by appropriately choosing their shape and material properties. The resilient beam is d to relax when the first beam head has reached the fifth ramp thereby engaging it in a manner that application of a translative force on the carrier in the distal direction deflects the resilient beam in the other transversal direction, e.g. inwards when a predetermined value of the translative force, at least depending on the resilience of the ent beam, is overcome so as to allow the first beam head to travel along the other transversal side of the rhomboid ramp member on continued ation of the carrier. The first beam head may also be allowed to relax behind the fourth ramp at the end of this motion for preventing the carrier from being advanced again, e.g. when the auto-injector is being heavily shaken after use. it goes without saying that the positions of the ent beam on the s and the rhomboid ramp member on the carrier may be switched without altering the function of the detent mechanism.

When the auto-injector or the syringe is assembled a protective needle sheath may be ed to the needle for keeping the needle sterile and preventing both, damage to the needle during assembly and handling and access of a user to the needle for avoiding finger stick es. l of the protective needle sheath prior to an injection usually requires a vely high force for pulling the protective needle sheath off the needle and needle hub in the proximal direction. in order to maintain pre injection needle safety and prevent exposure of the needle translation of the syringe in the proximal direction due to this force has to be avoided. For this e the case may be arranged to lock the detent mechanism prior to being translated in the proximal direction ve to the chassis when the chassis is being pressed against the injection site so as to avoid translation of the carrier. This may be achieved by a rib in the case preventing deflection of the resilient beam of the detent mechanism by supporting it outwardly.

Translation of the case is translated into the advanced position in the proximal direction 3O on contact to the injection site is arranged to unlock the detent mechanism rendering it operable. This may be achieved by the rib being moved with the case so as to no longer outwardly supporting the resilient beam of the detent mechanism. In order to ensure that the case is not moved in the al direction unlocking the detent mechanism before the tive needle sheath is removed a cap may be attached to the proximal end of the case so as to make the chassis inaccessible before the cap is removed. The cap preferably engages the protective needle sheath by means of a barb in a manner to remove the protective needle sheath when the cap is being pulled off the auto—injector.

In order to facilitate removal of the cap it may have a profiled surface mating with a surface on the case so that the cap is pulled off when rotated. The barb may be ted to the cap in a manner ng them to rotate independently so as to avoid torque on the protective needle sheath when the cap is rotated in order not to distort the 1O needle inside the tive needle sheath.

The distally arranged trigger button may be at least initially coupled to the carrier, wherein the case is arranged to abut the trigger button in the initial state ting sion of the trigger button. On translation of the case into the advanced position when the chassis is being pressed against the injection site the trigger button remains coupled to the carrier thus emerging from the case which has been moved relative to the chassis, carrier and trigger button so as to allow sion of the r button for starting an injection cycle. Thus a sequence of operation is defined for the auto-injector to be actuated, first pressing it against the injection site and then to push the trigger button. This reduces the risk of finger stick injuries particularly if the user were to be confused which end of the auto-injector to apply against their skin. Without a sequence the user would risk inserting the needle into their thumb which is icantly less probable with the forced sequence.

The syringe retraction control mechanism may comprise a second collar g against the distal end of the control spring and having a resilient proximal beam with a second beam head having an inward boss. The second beam head is arranged to be in a ramped engagement with a second case detent in the case in a manner ramping the second beam head in the inward direction under load of the control spring in the distal direction. The inward boss is arranged to inwardly abut the carrier for preventing inward deflection of the second beam head and keep the second collar locked to the case. A third recess is arranged in the carrier for allowing the inward boss to be inwardly deflected on translation of the case in the distal direction relative to the carrier on removal of the auto-injector from the injection site.

In an ative embodiment the first collar and/or the second collar may also be threaded to one of the components which they are intended to couple to the control spring wherein the case would be arranged to prevent the threads from decoupling in some relative longitudinal positions while ng the collar to rotate out of the ed engagement in other relative longitudinal positions so as to allow the collars to switch to the respective other ent to be coupled to the control spring. in an alternative embodiment the trigger button may be arranged distally, wherein the case is arranged as a wrap-over sleeve trigger having a closed distal end face covering the trigger button. In an initial state a clearance is provided between the distal end face of the sleeve trigger and the trigger button allowing for some travel of the sleeve trigger ’15 against the bias of the control spring in the proximal direction in a first phase before abutting the trigger button. As soon as the sleeve r has contacted the trigger button the trigger button is pushed by the sleeve trigger on further translation in a second phase. This embodiment allows for keeping the majority of the components of the auto-injector while oniy the bed es need mod ification aliowing to customize a platform device to particular requirements. An auto—injector with a sleeve trigger is particularly well suited for people with dexterity problems since, as d to conventional art auto-injectors, triggering does not require operation of small buttons by single fingers. Instead, the whole hand is used.

Retraction of the needle requires the user to lift the njector far enough from the injection site to allow the case or sleeve trigger to translate back in the distal direction to switch the l spring. As it may be difficult for the user to know if the injection is finished or not a able feedback component may be provided, capable of, upon release, generating an audible and/or tactile feedback to the user, wherein the feedback component is arranged to be ed when the plunger reaches a position relative to the syringe in which the stopper is located in proximity of a proximat end of the syringe, is. when the injection is at least almost ed. The released feedback , e.g., component then s on a housing component, such as the case, sleeve trigger or r button indicating the end of the injection. Impacting a directiy accessibie component ailows for high perceptibility of the noise and direct access to the user’s hand or finger for generating the tactile feedback. Preferably the feedback component may impact the trigger button which may be shaped as a drum for providing a loud noise.

The needle extension length or depth is ably defined by the carrier ve to the s not relative to the case, so if the user flinches or fails to hold the auto-injector hard against the ion site, only the case will move in the distai direction while the injection depth remains constant. As long as this case motion does not exceed a set distance the case does not yet switch the control spring for needle retraction.

The auto-injector may be operated by a number of key mechanical operations: — The case is advanced relative to the chassis compressing the l spring giving the user the impression of depressing a skin interlock sleeve. All other components remain in the same place during case advance resulting in the trigger button appearing from the distal end of the case.

- The user pushes the trigger button which can now be operated. Button depression directly moves the carrier and hence the drive sub—assembly in the proximal direction a set distance until the control spring takes over via the first collar and fully extends the needle, e.g. inserts the needle into the injection site.

- The trigger button stops on the distal end of the case as the carrier continues translating in the proximal direction. The motion of the carrier relative to the trigger button is used to release the drive spring just before full insertion depth is reached, eg. by pulling a peg on the r button out of the r thus allowing the plunger to move. The drive spring drives the plunger down the syringe barrel expeliing the medicament.

~ A feedback mechanism is released when the piunger is near the end of travel shortly before the stopper bottoms out in the syringe, providing audible and/or e indicator of the end of injection to the user.

The needle remains fuliy extended until the user moves the case back a set distance relative to the chassis at which point the second collar decouples from the case and couples to the carrier while the first collar decouples from the carrier and couples to the chassis thus allowing the control spring to retract the carrier and hence the needle.

The auto—injector may ably be used for subcutaneous or intra-muscular injection, particularly for delivering one of an analgetic, an anticoagulant, insulin, an insulin derivate, heparin, Lovenox, a vaccine, a growth hormone, a peptide hormone, a 1O proteine, antibodies and complex carbohydrates. The auto-injector may preferably be adapted to be used for ing a liquid medicament with high viscosity, e.g. liquid solutions of antibody medicaments.

The term medicament", as used herein, means a pharmaceutical formulation containing at least one ceutically active compound, n 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, a antibody, an enzyme, an antibody, a hormone or an oiigonucieotide, or a mixture of the above-mentioned pharmaceuticaliy active nd, wherein in a further embodiment the pharmaceutically active compound is useful for the treatment and/or laxis of diabetes meliitus or complications associated with es mellitus such as diabetic retinopathy, thromboembolism disorders such as deep vein or pulmonary thromboembolism, acute coronary syndrome (ACS), , myocardial infarction, cancer, macuiar degeneration, inflammation, hay fever, atherosclerosis and/or rheumatoid arthritis, wherein in a further embodiment the ceutically active compound comprises at least one peptide for the treatment and/or prophylaxis of diabetes us or complications ated with diabetes mellitus such as diabetic retinopathy, wherein in a r embodiment the pharmaceutically active compound comprises at least one human insulin or a human insulin analogue or derivative, glucagon-like peptide (GLP-i) or an analogue or derivative thereof, or exedin~3 or exedin—4 or an analogue or derivative of exedin-S or exedin-4.

Insulin analogues are for example Gly(A21), Arg(BB1), Arg(B32) human insulin; Lys(BS), 9) human insulin; 28), Pro(829) human insulin; 8) human insulin; human insulin, wherein proline in position 828 is ed by Asp, Lys, Leu, Val or Ala and wherein in position 829 Lys may be replaced by Pro; Ala(826) human insulin; 1O Des(828-B30) human n; Des(BZ7) human insulin and Des(l330) human insulin.

Insulin derivates are for example BZQ—N-myristoyl-des(830) human insulin; BZQ-N- palmitoyl-des(l330) human insulin; BZQ-N-myristoyl human insulin; palmitoyl human insulin; B28-N~myristoyl LysBZBProBZQ human insulin; 828~N~palmitoyl~ LysBZSProBZQ human insulin; BBO-N-myristoyl-ThrBZQLysBBO human insulin; B30-N- palmitoyl— ThrBZQLysBSO human n; BZQ-N-(N—palmitoyl-Y—glutamyl)-des(830) human insulin; (N~lithocho|yI-Y-glutamyl)«des(BSO) human insulin; BZQ~N—(w- carboxyheptadecanoyl)~des(830) human insulin and BZQ-N-(w-carboxyheptadecanoyl) human insulin.

Exendin-4 for e means Exendin—4(1-39), a peptide of the ce H-His-Gly~ GIu-GIy—Thr—Phe-Thr—Ser—Asp-Leu-Ser—Lys-Gln—Met—Glu—GIu—G|u~Ala~Va|~Arg~Leu~Phe- lle-Glu—Trp-Leu~Lys~Asn—Gly-Gly-Pro-Ser—Ser—GIy—AIa-Pro-Pro-Pro-Ser-NH2.

Exendin-4 derivatives are for example selected from the following list of compounds: H~(l_ys)4-des Pr036, des Pr037 Exendin~4(1-39)-NH2, H~(Lys)5-des Pr036, des Pr037 Exendin-4(1-39)—NH2, des Pr036 [A5928] Exendin-4(1-39), des Pr036 [IsoAsp28] Exendin~4(1~39), des Pr036 [Met(O)14, Asp28] Exendin~4(1~39), des Pr036 [Met(O)14, lsoAsp28] Exendin-4(1-39), des Pro36 [Trp(02)25, Asp28] Exendin-4(1~39), des Pro36 [Trp(02)25, lsoAsp28] Exendin-4(1-39), des Pr036 )14 )25, Asp28] Exendin-4(’i—39), des Pr036 [Met(O)14 Trp(02)25, lsoAspZS] Exendin-4(1-39); or des Pro36 [Asp28] Exendin-4(1-39), des Pr036 [IsoAsp28] Exendin-4(1-39), des Pr036 [Met(O)14, Asp28] n—4(1~39), des Pro36 [Met(0)14, lsoAsp28] n~4(1~39), 1O des Pro36 [Trp(02)25, Asp28] ExendEn-4(’i-39), des Pro36 [Trp(02)25, isoAsp28] n—4(1—39), des Pr036 [Met(O)14 Trp(02)25, Asp28} Exendin-4(1-39), des Pr036 [Met(O)14 Trp(02)25, lsoAsp28] Exendin-4(1-39), wherein the group -Ly36-NH2 may be bound to the C-terminus of the Exendin-4 tive; or an Exendin~4 derivative of the sequence H-(Lys)6-des Pr036 [Asp28] Exendin-4(1~39)—Lys6-NH2, des Asp28 Pro36, Pr037, Pr038Exendin-4(1-39)—NH2, H~(Lys)6-des Pr036, Pr038 [Asp28] Exendin~4(1~39)—NH2, H-Asn-(Glu)5des Pr036, Pr037, Pr038 [Asp28] Exendin-4(1-39)-NH2, des Pro36, Pro37, Pr038 [Asp28] Exendin-4(1-39)-(Lys)6—NH2, )6-des Pro36, Pr037, Pr038 [Asp28] Exendin-4(1-39)—(Lys)6-NH2, H-Asn-(Giu)5-des Pro36, Pr037, Pr038 [Asp28] Exendin-4(‘i~39)-(Lys)6-NH2, H-(Lys)6—des Pro36 [Trp(02)25, Asp28] Exendin-4(1-39)-Lys6-NH2, H—des Asp28 Pr036, Pr037, Pr038 [Trp(02)25] Exendin-4(1—39)~NH2, H-(Lys)6—des Pr036, Pr037, Pr038 [Trp(02)25, Asp28] Exendin-4(1~39)~NH2, H~Asn-(G|u)5-des Pr036, Pr037, Pr038 [Trp(02)25, Asp28] n-4(1-39)—NH2, des Pr036, Pr037, Pr038 [Trp(02)25, Asp28] Exendin-4(1-39)-(Lys)6—NH2, H-(Lys)6-des Pr036, Pr037, Pr038 [Trp(02)25, Asp28] Exendin~4(1-39)—(Lys)6-NH2, H—Asn-(Glu)5-des Pr036, Pr037, Pr038 [Trp(O2)25, Asp28] Exendin~4(‘i~39)—(Lys)6—NH2, H-(Lys)6-des Pr036 [Met(O)14, Asp28] Exendin-4(‘i—39)—LysG-NH2, des Met(O)14 Asp28 Pr036, Pr037, Pr038 Exendin-4(1-39)—NH2, H—(Lys)6—desPr036, Pr037, Pro38 [Met(O)14, Asp28] Exendin—4(1-39)-NH2, H-Asn-(Glu)5-des Pr036, Pr037, Pr038 [Met(O)14, Asp28] Exendin-4(t-39)—NH2, des Pr036, Pro37, Pro38 [Met(O)14, Asp28] Exendin~4(1~39)-(Lys)6~NH2, )6-des Pr036, Pro37, Pr038 [Met(O)14, Asp28] Exendin-4(1-39)—(Lys)6—NH2, H—Asn-(Glu)5 des Pr036, Pr037, Pr038 [Met(O)14, Asp28] Exendin~4(1~39)—(Lys)6—NH2, H-LysS-des Pro36 )14, Trp(02)25, Asp28] Exendin-4(1-39)—Ly36-NH2, H-des Asp28 Pro36, Pr037, Pr038 [Met(O)14, )25] Exendin-4(1-39)—NH2, H~(Lys)6-des Pr036, Pr037, Pr038 [Met(O)l 4, Asp28] Exendin-4(1-39)—NH2, ‘10 H-Asn-(Glu)5-des Pr036, Pr037, Pro38 )14, Trp(02)25, Asp28] Exendin-4(1-39)- NH2, des Pr036, Pr037, Pr038 [Met(O)14, Trp(02)25, Asp28] Exendin-4(1~39)-(Lys)6-NH2, H-(Lys)6~des Pr036, Pr037, Pr038 )14, Trp(02)25, Asp28] Exendin~4(S1-39)- (Lys)6-NH2, ‘15 H-Asn-(Glu)5~des Pr036, Pr037, Pro38 [Met(0)14, Trp(02)25, Asp28] Exendin-4(1-39)— (Lys)6-NH2; or a pharmaceutically acceptable salt or solvate of any one of the afore-mentioned Exedin~4 derivative. es are for example hypophysis hormones or hypothalamus hormones or regulatory active peptides and their antagonists as listed in Rote Liste, ed. 2008, Chapter 50, such as Gonadotropine (Follitropin, Lutropin, ngonadotropin, Menotropin), Somatropine (Somatropin), Desmopressin, Terlipressin, relin, Triptorelin, Leuprorelin, Buserelin, Nafarelin, Goserelin.

A polysaccharide is for example a aminoglycane, a hyaluronlc acid, a heparin, a low molecular weight heparin or an ultra low molecular weight heparin or a derivative thereof, or a ted, eg. a poly-sulphated form of the above-mentioned polysaccharides, and/or a pharmaceutically acceptable salt thereof. An example of a pharmaceutically acceptable salt of a poly-sulphated low molecular weight heparin is enoxaparin sodium.

Pharmaceutically acceptable salts are for example acid addition salts and basic salts.

Acid addition salts are e.g. HCI or HBr salts. Basic salts are e.g. salts having a cation selected from alkali or alkaline, e.g. Na+, or K+, or 032+, or an ammonium ion N+(R‘i)(R2)(R3)(R4), wherein R1 to R4 independently of each other mean: hydrogen, an ally substituted Ct-C6-alkyl group, an optionally substituted C2—C6~alkenyl group, an optionally substituted CG-C10-aryl group, or an optionally substituted 06 heteroaryl group. Further examples of pharmaceutically acceptable salts are described in "Remington's Pharmaceutical Sciences" 17. ed. Alfonso R. o (Ed), Mark Publishing Company, , Pa., U.S.A., 1985 and in Encyclopedia of Pharmaceutical Tech nology.

Pharmaceutically acceptable solvates are for example hydrates.

The drive spring and control spring may be compression springs. However, they may likewise be any kind of stored energy means such as torsion s, gas springs etc.

Further scope of applicability of the present invention will become apparent from the detailed ption given hereinafter. However, it should be tood that the detailed description and ic examples, while indicating red 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 3O illustration only, and thus, are not limitive of the present invention, and wherein: Figure 1 shows two longitudinal sections of an auto-injector in different section planes in a state priorto use, Figure 2 shows two longitudinal sections of the auto~injector after removal of a cap and a tive needle sheath, Figure 3 shows two longitudinal sections of the auto-injector with the case moved in al direction relative to the chassis, 1O Figure 4 shows two longitudinal sections of the auto—injector with a r button depressed, Figure 5 shows two longitudinal sections of the auto-injector during needle extension, Figure 6 shows two longitudinal sections of the auto—injector with the needle in extended proximal on, Figure 7 shows two longitudinal sections of the auto-injector during ing the medicament, Figure 8 shows two longitudinal sections of the auto—injector where the stopper is located in proximity of a proximal end of the syringe, Figure 9 shows two longitudinal sections of the auto-injector where the case is moved in distal direction relative to the chassis, Figure 10 shows two longitudinal sections of the auto~injector with the needle retracted into a needle safe position, Figure 11 shows schematic views of a detent mechanism for controlling movement of a carrier relative to a chassis of the auto-injector in four different states, Figure 12 shows schematic views of a needle extension control mechanism for controlling movement of a first collar in six different states, Figure 13 shows schematic views of a syringe retraction control mechanism in three different states Figure 14 shows schematic views of a feedback release mechanism for audibly and/or tactily indicating the end of injection in three ent states, Figure 15 shows schematic views of a r release mechanism in three different states, Figure 16 shows tic views of a button e ism in three ent states, Figure 17 is an isometric view of an alternative embodiment of the plunger release mechanism, Figure 18 is a longitudinal section of an alternative embodiment of the button reiease mechanism, Figure 19 shows longitudinal sections of an alternative embodiment of the detent mechanism, Figure 20 is a longitudinal section of a third embodiment of the detent mechanism, Figure 21 is a longitudinal section of an alternative embodiment of the feedback release mechanism, Figure 22 shows longitudinal sections of an ative ment of the needle extension control mechanism, also arranged to perform the function of the detent ism on needle retraction and needle extension, Figure 23 is an isometric View of the needle extension control mechanism of figure 22, Figure 24 shows udinal sections of a third embodiment of the needle extension control mechanism, also arranged to perform the functions of the detent ism, Figure 25 is an isometric view of the needle extension control mechanism of figure 24, Figure 26 shows longitudinal sections of a third embodiment of the feedback release mechanism, and Figure 27 is another embodiment of the auto-injector having a wrap-over sleeve trigger instead of a trigger button.

Corresponding parts are marked with the same reference symbols in all figures.

Detailed Description of red Embodiments A ramped engagement in the terminology of this specification is an engagement between two components with at least one of them having a ramp for engaging the other component in such a manner that one of the components is flexed aside when the ents are axially pushed t each other provided this component is not prevented from flexing aside.

Figures 1a and 1b show two longitudinal sections of an auto-injector 1 in different section planes, the ent section planes approximately 90° rotated to each other, wherein the auto~injector 1 is in an initial state prior to ng an injection. The auto- lnjector 1 comprises a chassis 2. In the following the chassis 2 is generally considered as being fixed in position so motion of other components is described relative to the chassis 2. A syringe 3, eg. a Hypak e, with a hollow injection needle 4 is arranged in a proximal part of the auto—injector 1. When the auto-injector 1 or the e 3 is led a protective needle sheath 5 is attached to the needle 4. A stepper 6 is arranged for sealing the e 3 distally and for displacing a liquid medicament M through the hollow needle 4. The syringe 3 is held in a tubular carrier 7 and supported at its proximal end therein. The carrier 7 is slidably arranged in the chassis 2.

A drive spring 8 in the shape of a compression spring is arranged in a distal part of the carrier 7. A plunger 9 serves for forwarding the force of the drive spring 8 to the stopper 6.

The drive spring 8 is loaded between a distal r end face 10 of the carrier 7 and a thrust face 11 arranged distally on the plunger 9.

The carrier 7 is a key element housing the syringe 3, the drive spring 8 and the plunger 9, which are the components required to expel the medicament M from the syringe 3.

These components can therefore be referred to as a drive sub—assembly.

The chassis 2 and the carrier 7 are arranged within a tubular case 12. A trigger button 13 is ed at a distal end of the case 12. in a plunger release mechanism 27 a peg 14 protrudes from a distal end face of the trigger button 13 in the proximal direction P between two resilient arms 15 originating from the distal carrier end face 10 thus preventing them from flexing s each other in an initial state A illustrated in figure 15A. ln figure 15A only one of the resilient arms 15 is shown to illustrate the principle.

Outwardly the resilient arms 15 are caught in respective first recesses 16 in a distal plunger sleeve 17 attached ly to the thrust face 11 and arranged inside the drive spring 8. The engagement of the resilient arms 15 in the first recesses 16 prevents axial translation of the plunger 9 relative to the carrier 7. The resilient arms 15 are ramped in a manner to flex them inwards on reiative motion between the plunger 9 and the r 7 under load ofthe drive spring 8, which is ted by the peg 14 in the initial state A.

The r 7 is locked to the chassis 2 for preventing relative translation by a detent mechanism 18 illustrated in more detail in figures 11A to 11D.

The trigger button 13 is initially engaged to the case 12 by a button release mechanism 26 and cannot be depressed. The button release mechanism 26 is illustrated in detail in figures 16A to 16C. Referring now to figure 16A the button release mechanism 26 comprises a resilient proximal beam 13.1 on the trigger button 13, the proximal beam 13.1 having an outward first ramp 13.2 and an inward second ramp 13.3. in an initial state A illustrated in figure 16A the outward first ramp 13.2 is engaged in a ramped first case detent 12.1 preventing the trigger button 13 from moving out of the distal and D.

The trigger button 13 aliy abuts both the case 12 and the carrier 7 hence being prevented from being depressed in the proximal direction P.

Referring again to figures 1A and 18 a control spring 19 in the shape of r compression spring is arranged around the carrier 7 and acts between a al first collar 20 and a distal second collar 21. The l spring 19 is used to move the carrier 7 and hence the drive sub-assembly in the proximal direction P for needle extension or in the distal direction D for needie tion.

In the state as delivered as shown in figures 1a and 1b a cap 22 is attached to the proximai end ofthe case 12 and the protective needle sheath 5 is still in piace over the needle 4 and the needie hub. An inner sleeve 22.1 of the cap 22 is arranged inside the chassis 2 and over the protective needle sheath 5. In the inner sleeve 22.1 a barb 23 is attached. The barb 23 is engaged to the protective needle sheath 5 for joint axial ation.

A sequence of operation of the auto-injector 1 is as follows: A user pulls the cap 22 from the proximal end of the case 12. The barb 23 joins the protective needle sheath 5 to the cap 22. Hence, the protective needle sheath 5 is also removed on removal of the cap 22. s 2a and 2b show the njector 1 with the cap 22 and needle sheath 5 removed. The carrier 7 and syringe 3 are prevented from moving in the proximal direction P by the detent mechanism 18 being in a state A as in figure 11A. Referring now to figure 11A, the detent mechanism 18 comprises a resilient beam 2.1 on the chassis 2 with an inwardly ding first beam head 2.2. The first beam head 2.2 has a proximal third ramp 2.3. The detent mechanism 18 further ses a rhomboid ramp member 7.1 on the carrier 7 having a proximal fourth ramp 7.2 and a distal fifth ramp 7.3. In state A a rounded off distal side of the first beam head 2.2 abuts the ramp member 7.1 in the distal direction D resisting movement of the carrier 7 in the proximal direction P relative to the chassis 2. A rib on the case 12 is provided for preventing outward deflection of the resilient beam 2.1 y also preventing motion of the r 7 relative to the chassis 2.

Referring again to figures 2A and 2B the user grabs the case 12 and places the chassis 2 protruding from the case 12 at the proximal end P against an injection site, eg. a patient’s skin. As the auto-injector 1 is pressed against the injection site the case 12 translates in the proximal direction P relative to the chassis 2 into an advanced position as illustrated in figures 3A and 3B. The second collar 21 is locked to the case 12 and is moved with the case 12 relative to the chassis 2 and relative to nearly all other components of the njector 1 thus slightly compressing the control spring 19 against the first collar 20 which is prevented from moving in the proximal direction P by the chassis 2 due to a needle extension control mechanism 24 being in a state A illustrated in detail in figure 12A. Referring now to figure 12A, a resiiient member in the shape of an arrowhead 20.1 is proximally arranged on the first collar 20. The first collar with the arrowhead 20.1 is being forced in the proximal direction P under load of the compressed control spring 19. An d sixth ramp 20.2 on the arrowhead 20.1 interacts with a second distal seventh ramp 2.4 on the chassis 2 ramping the arrowhead .1 in an inward ion [which is prevented by the arrowhead 20.1 inwardly abutting the carrier 7. Hence. the first collar 20 cannot translate in the proximal ion P.

Referring again to figures 3A and 3B the second collar 21 is locked to the case due to a syringe retraction control mechanism 25 being in a state A illustrated in detail in figure 13A. Referring now to figure 13A, the syringe retraction control mechanism 25 comprises a resilient proximal beam 21 .t on the second collar 21, the proximal beam 1O 21.1 having a second beam head 21.2 having an inward boss 21.3 and a distal outward eighth ramp 21.4. The distal outward eighth ramp 21.4 is engaged in a ramped second case detent 12.2 in a manner ramping the second beam head 21.1 in the inward direction I with the second collar 21 under load of the control spring 19 in the distal direction D which is ted by the inward boss 21.3 inwardly abutting the carrier 7.

Referring again to figures 3A and BB, if the user was to move the case 12 away from the injection site, the control spring 19 s returning the auto-injector 1 to the initial ion after removal of the cap 22 as illustrated in figures 2A and 28.

In the state as in figures 3A and 3B the carrier 7 continues to be prevented from moving in the proximal direction P by the detent mechanism 18, however with the case 12 in its advanced on the detent mechanism 18 is unlocked as the rib on the case 12 has also moved and no longer prevents outward deflection of the resilient beam 2.1.

Movement of the case 12 relative to the carrier 7, which is locked to the chassis 2 by the detent mechanism 18, causes the button release mechanism 26 to switch to a state B illustrated in figure 16B. The trigger button 13 cannot translate with the case 12 in the proximal direction P as it is abutted against the carrier 7. The ramp on the first case detent 12.1 interacts with the outward first ramp 13.2 on the proximal beam 13.1 on the r button 13 deflecting the proximal beam 13.1 in the inward direction I thus engaging the inward second ramp 13.3 on the proximal beam 13.1 in a ramped r detent 7.4 arranged in the carrier 7. As the case 12 is translated further in the proximal direction P it ts the proximal beam 13.1 outwardly thus locking the trigger button 13 to the carrier 7. The trigger button 13 now protrudes from the distal end D of the chassis 12 and is ready to be pressed.

In the state as in figures 3A and SB the user depresses the r button 13 in the proximal direction P. As the trigger button 13 abuts against the carrier 7 the carrier 7 is pushing in the proximal direction P against the chassis 2, the carrier 7 and the chassis 2 interacting in the detent mechanism 18. The force exerted by the user ng the trigger button 13 is ed through the chassis 2 onto the injection site, not between the trigger button 13 and the case 12. The detent mechanism 18 provides a resistive 1O force when the user pushes the trigger button 13. Once the user applies a force which exceeds a pre-determined value the detent mechanism 18 releases, initiating the injection cycle. Referring now to figure 11B showing the detent mechanism 18 in a state B, the resilient beam 2.1 on the chassis 2 begins to bow under load from the rhomboid ramp member 71 on the carrier 7, g elastic . Despite the proximal fourth ramp 7.2 on the ramp member 7.1 friction between the contacting faces of the first beam head 2.2 and the proximal fourth ramp 7.2 prevents movement of the first beam head 2.2 in the outward direction 0 until the htening force in the resiliently deformed beam 2.1 is sufficiently large to overcome it. At this point the resilient beam 2.1 is deflected in the outward direction 0 moving out of the way of the carrier 7 thus allowing the carrier 7 to translate in the proximal direction P. When the carrier 7 travels sufficiently far in the ai direction P the id ramp member 7.1 on the carrier 7 passes under the first beam head 2.2 thus allowing it to relax and move back in the inward direction 1 distally behind the rhomboid ramp member 7.1 in a state C iliustrated in figure 110 at the same time constraining transiation of the carrier 7 in the distal direction D ve to the chassis 2.

Once the carrier 7 siides far enough in the proximal direction P relative to the first collar the needle extension control mechanism 24 is switched to a state B as illustrated in figure 128. in figure 128 the carrier 7 has been translated in the proximai direction P in such a mannerthat the arrowhead 20.1 on the first collar 20 is no longer inwardly supported. This may be achieved by a second recess 7.5 in the carrier 7. The arrowhead 20.1 is now deflected in the inward direction I into the second recess 7.5 under load of the control spring 19 arriving at a state C as illustrated in figure 120. The first collar 20 is now led from the chassis 2. d, the arrowhead 20.1 couples the first collar 20 to the carrier 7 by an inward ninth ramp 20.3 engaging a distal tenth ramp 7.6 on the carrier 7 at the proximal end of the second recess 7.5. Hence, the l spring 19 continues moving the carrier 7 in the proximal direction P from this point. Whilst the user advances the needle 4 by a proportion of its travel, the control spring 19 takes over insertion before the needle 4 protrudes from the proximal end P.

Therefore the user experience is that of pressing a button, ratherthan manually inserting a needle.

The detent mechanism 18 relies on the user applying a force rather than a displacement.

Once the force applied exceeds the force ed to switch the detent the user will push the trigger button 13 fully, ensuring that the first collar 20 will always switch. if the user fails to pass the detent, the trigger button 13 returns to its unused state ready for use as illustrated in s 3A and BB. This feature avoids the auto-injector 1 arriving in an undefined state.

Figures 4A and 4B show the autowinjector1 with the trigger button 13 depressed sufficiently for the l spring 19 to couple on to the carrier 7 and continue moving the carrier 7 forwards, but not yet abutting the case 12.

The carrier 7 d to the first collar 20 is ated in the proximal direction P driven by the control spring 19. As the syringe 3 is arranged for joint axial translation with the carrier 3 the syringe 3 and needle 4 are also translated resulting in the needle 4 protruding from the proximal end P and being inserted into the injection site. The trigger button 13 returns to its initial position relative to the case 12 and latches back to the case 12 from the carrier 7 as in state A in figure 16 A. The carrier 7 translates further in the proximal direction P preventing inward deflection of the proximal beam 13.1 so the outward first ramp 13.2 cannot disengage from the first case detent 12.1. immediately prior to the needle 4 reaching full ion depth as illustrated in figures 5A and SB the peg 14 on the trigger button 13 is completely pulled out from between the resilient arms 15 on the carrier 7. Hence, the plunger release mechanism 27 arrives in a state 8 shown in figure 158 with the resilient arms 15 no longer inwardly supported by the peg 14. Due to the ramped engagement of the ent arms 15 in the first recess 16 they are deflected in the inward direction I under load of the drive spring 8 arriving in a state B illustrated in figure 15C. Hence, the plunger 9 is ed from the carrier 7 and driven in the proximal direction P by the drive spring 8, ready to expel the ment M. The force to pull the peg 14 out from between the resilient arms 15 is provided by the control spring 19 while the force required to deflect the resilient arms 15 out of engagement to the piunger 9 is provided by the drive spring 8.

White the plunger 9 moves and closes a gap to the stopper 6 the movement of the carrier 7 in the al direction P is completed by the control spring 19 pushing the first collar 20. As the carrier 7 moves with respect to the chassis 2 during needle extension the needie extension mechanism 24 arrives in a state D iilustrated in figure 12D. The ead 20.1 has moved with the carrier 7 and is still kept inwardly deflected by the chassis 2 thus preventing the first collar 20 from disengaging the carrier 7. The arrowhead 20.1 must be able to t in the outward direction 0 to allow retraction which will be discussed below. In order to allow outward deflection the arrowhead 20.1 travels proximally beyond the part of the chassis 2 shown in figures 12A to 12i= next to an aperture 2.5 in the s 2. However, as long as the case 12 is being kept pressed t the injection site and not allowed to return in the distal direction D beyond a predefined distance under load of the control spring 19 the arrowhead 20.1 will be kept from deflecting in the outward direction 0 by a first rib 12.3 on the case 12 (not illustrated in s 12A to F, see figures 5A to 8A) during about the second half of its motion for needle extension.

The needle 4 is now fully inserted into the injection site as illustrated in figures 6A and GB. The time between the trigger button 13 pressed and the needle 4 being fully inserted is very short, however several mechanical operations take place in this time. 3O The needle extension depth is defined by the carrier 7 relative to the chassis 2 not relative to the case 12, so if the user flinches or fails to hold the auto—injector 1 hard against the skin, only the case 12 will move in the distal direction D while the ion depth s constant.

As soon as the plunger 9 has closed the gap to the stopper 6 under force of the drive spring 8 the stopper 6 is pushed in the proximal direction P within the syringe 3 displacing the medicament M through the needle 4. immediately prior to the end of expelling the medicament with the stopper 6 having almost bottomed out in the syringe 3 as illustrated in figures 7A and 78 a feedback 1O ent 28 is released. The stack up of tolerances, most notably due to the syringe 3 requires that the feedback must always be ed prior to fuliy expelling the medicament. ise, with certain combinations of parts, the feedback would not always release. The feedback component 28 comprises an elongate portion 28.1 arranged within the distal plunger sleeve 17 and a distal end plate 28.2 arranged between the carrier end face 10 and an end face of the trigger button 13. Two second ent arms 30 originate from the distal carrier end face 10 and extend in the proximal direction P. A feedback spring 29 is ed to bias the feedback component 28 in the distal direction D relative to the carrier 7 by proximaily bearing against a rib on the second resilient arms 30 and distally against the feedback component 28 (not iilustrated).

Note: the feedback ent 28 is not illustrated in figures 16A, B and C for clarity since it does not affect the function of the button release ism 26. A feedback release mechanism 31 for releasing the feedback component 28 is schematically illustrated in figures 14A, 14B and 14C. Referring now to figure 14A, the feedback release mechanism 31 ses the second resilient arms 30. A ramped inward boss .1 is ed on each second resilient arm 30 which is engaged to a respective outward eleventh ramp 28.3 on the elongate portion 281 of the ck component 28 in such a manner that the second resilient arm 30 is deflected in the outward direction 0 3O under load of the feedback spring 29. in an initial state A of the feedback release mechanism 31 the second resilient arms 30 are prevented from being outwardly deflected by outward support of the distal plunger sleeve 17 thus preventing translation of the feedback component 28 relative to the carrier 7. The feedback release mechanism 31 remains in state A until immediately priorto fully expelling the medicament with the stopper 6 having almost bottomed out in the syringe 3 as illustrated in figures 7A and 78. At this point the plunger 9 has been translated in the al ion P relative to the carrier 7 to such an extent that the second resilient arms 30 are no longer supported by the distal plunger sleeve 17. The ck release mechanism 31 has thus arrived in a state B illustrated in figure 14B. Due to the ramped engagement between the ramped inward boss 30.1 and the outward th ramp 28.3 the second resilient arm 30 is outwardly deflected under load of the feedback 1O spring 29 thus disengaging the feedback component 28 from the carrier 7 and allowing the feedback component 28 to move in the distai direction D driven by the feedback spring 29 in a state C illustrated in figure 140. Hence, the feedback component 28 is rated in the distal direction D and the distal end plate 28.2 impacts on the inside of the trigger button 13 producing audible and tactile feedback to the user that expelling the medicament is about finished.

Figures 8A and BB show the auto-injector1 with the stopper 6 having entirely bottomed out in the syringe 3.

As ned above the user is able to let the case 12 move by a few millimetres in the distal direction D under the force of the control spring 19 t affecting the position of the needle 4 as long as that motion is below a predefined distance. lfthe user wishes to end the injection, at any time, they must allow the case 12 to move in the distal direction D beyond that ce. Figures 9A and 9B show the auto-injector 1 with the chassis extended, eg. when lifted from the injection site with the case 12 moved all the way in the distal ion D so that the chassis 2 protrudes from the proximal end of the case 12. As the case 12 is moved the first collar 20 releases the carrier 7 and then the second collar 21 releases from the case 12 and pulls the carrier 7 in the distal direction D. The sequencing of this switching is critical as retraction will fail if both collars 20, 21 are attached to the carrier 7 at the same time. This is overcome by ting the switching of the collars 20, 21 by a significant dispiacement of the case 12.

The switching ofthe first collar 20 is illustrated in figures 12E and F. In figure 12E the case 12 has been allowed to move in the distal direction D under load of the l spring 19, e.g. during removal of the auto-injector1 from the injection site. The first rib 12.3 (not illustrated, see figure 9A) is removed from outwardly behind the arrowhead .1. The first collar 20 is still being pushed in the proximal direction P by the control spring 19. Due to the engagement of the inward ninth ramp 20.3 on the arrowhead 20.1 with the distal tenth ramp 7.6 on the carrier 7 the arrowhead 20.1 is deflected in the outward ion 0 into the aperture 2.5 of the chassis 2 (illustrated in figures 12A to 12F), the needle extension control mechanism 24 arriving in a state E as illustrated in figure 12E, decoupling the first collar 20 from the carrier 7 and latching it to the chassis As the case 12 is moving further in the distal ion D relative to the chassis, e.g. on removal from the ion site, the syringe retraction control mechanism 25 switches from its state A (cf. figure 13A) into a state B illustrated in figure 138. The case 12 and the second collar 21 locked to the case 12 move together in the distal direction D while the carrier 7 is held in place by the detent mechanism 18 in its state C as described above (of. figure 110). Due to this motion the inward boss 21.3 on the second beam head 21.2 of the proximal beam 21.1 on the second collar 21 no longer inwardly abuts the carrier 7. d the inward boss 21.3 is deflected in the inward direction I into a third recess 7.7 in the carrier 7 due to the ramped ment of the second beam head 21.1 to the ramped second case detent 12.2 under load of the l spring 19.

The syringe retraction l mechanism 25 thus arrives in a state C as illustrated in figure 130 with the second collar 21 decoupled from the case 12 and coupled to the carrier 7. The detent mechanism 18 applies a small retarding force to the movement of the carrier 7 before the syringe retraction control mechanism 25 switches to state C as there is a small sliding force, applied by the second collar 21, pulling the carrier 7 in the distal direction D on translation of the case 12 in the distal direction D when the needle extension control mechanism 24 has already been switched into state E. If the carrier 7 moves too far in the distal direction D before the second collar 21 switches, the case 12 runs out of travel before the inward boss 21.3 can t into the third recess 7.7 preventing retraction.

Starting from the position C of the detent ism 18 (cf. fig. 11C) the carrier 7 and hence the rhomboid ramp member 7.1 are translated in the distal direction D under load of the control spring 19. Hence, the distal fifth ramp 7.3 of the rhomboid ramp member 7.1 engages the proximal third ramp 2.3 on the first beam head 2.2 of the resilient beam 2.1 in a manner deflecting the resilient beam 2.1 in the inward direction I. This s the small retarding force to the movement of the carrier 7 required for ensuring the switching ofthe second collar 21 to the r 7. The resilient beam 2.1 and the rhomboid ramp member 7.1 are offset sideways to allow the ent beam 2.1 to pass without contacting the rhomboid ramp member 7.1 as soon as the first beam head 2.2 is entirely inwardly from the ramp member 7.1 in a state D illustrated in figure 11D.

The control spring 19 is grounded at its proximal end in the case by the first collar 20 being abutted against the chassis 2. The distal end of the control spring 19 moves the second collar 21 in the distal direction D taking with it the carrier 7 and hence the syringe 3 with the needle 4 overcoming the detent mechanism 18 as illustrated in figure 11D. Note that the needle 4 is retracted by the auto-injector 1 as soon as the user allows the case 12 to translate sufficiently far as opposed to auto-injectors with needle shields which require the user to remove the auto~injector from the injection site thereby themselves pulling the needle out of the skin for allowing the needle shield to e.

As the movement allowed of the ck component 28 is limited ve to the carrier 7 it is no longer in contact with the trigger button 13 which has moved in the distal direction D with the case 12 on removal from the ion site.

When the retraction begins the feedback spring 29 does not provide any retarding force.

Once the feedback component 28 hits the trigger button 13 again on retraction of the carrier 7 the feedback spring 29 must be recompressed, reducing the force driving the final part of retraction. In order to ensure a reliable retraction e this reducing force the control spring 19 must be appropriately dimensioned.

The retraction ends when the distal collar 21 meets a first back stop 12.4 on the case 12 as in figures 10A and 10B. The arrowhead 20.1 on the first collar 20 is inwardly ted by the carrier 7 in a state F rated in figure 12F and thus prevented from deflecting in the inward direction 1. The outward sixth ramp 20.2 of the arrowhead 20.1 is engaged behind the first rib 12.3 on the case 12 preventing the case 12 from being pushed in the proximal direction P again. A clearance may be provided between the arrowhead 20.1 and the first rib 12.3 to allow fortolerances.

The detent ism 18 returns to state A as in figure 11A locking the carrier 7 in on relative to the chassis 2 as it did initially, however it cannot be unlocked now as the case 12 cannot move relative to the chassis 2.

A tab 20.4 on the first collar 20 is now visible through an indicator window 32 in the case 12 -— indicating the njector 1 has been used.

Figure 17 is an isometric View of an alternative embodiment of the r reiease mechanism 27. The plunger release mechanism 27 prevents movement of the plunger 9 in the proximal direction P relative to the carrier 7 until the carrier 7 is moved in the proximai direction P for needle extension. As d to the plunger release 2O mechanism 27 of figure 15, where relative movement of the carrier 7 and r button 13 are used to r the release of the plunger 9, the alternative embodiment of figure 17 releases the plunger 9 by movement of the carrier 7 ve to the second collar 21. Figure 17 illustrates the plunger release mechanism 27 prior to plunger release. The second collar 21 is shown transparent to improve clarity. The plunger 9 is being pushed in the proximal direction P by the drive spring 8. In order for the plunger 9 to advance, it must rotate around a twelfth ramp 7.8 on the carrier 7. A ramp member 9.1 on the plunger 9 is arranged to engage this twelfth ramp 7.8. Rotation of the ramp member 9.1 is blocked by an inward longitudinai rib 21.5 on the second collar 21 splined in a longitudinal aperture 7.9 in the carrier 7. The case 12 and the second collar 3O 21 remain in the same position, is coupled to each otherforjoint axial translation. On depression of the r button 13 the carrier 13 and the plunger 9 being part of the drive sub-assembiy are moved in the proximal direction P, first by the user pressing the trigger button 13 and then by the controi spring 19 taking over via the first collar 20 as described above. Once the carrier 7 moves sufficiently far in the proximal direction P relative to the second collar 21 the ramp member 9.1 on the collar 9 comes clear of the longitudinal rib 21.5 on the second collar 21 and can rotate past the proximal end of the longitudinal rib 21.5 due to its ramped engagement to the twelfth ramp 7.8 under load of the drive spring 8. Hence, the drive spring 8 advances the plunger 9 in the proximal ion P for expelling the medicament M.

Figure 18 is a longitudinal section of an alternative embodiment of the button release ism 26. Other than the button release mechanism 26 of figure 16 which gives the appearance of a revealing trigger button 13 on skin contact by ing the ground of the trigger button 13 between the carrier 7 and the case 12, the button release ism 26 of figure 18 starts with the trigger button 13 locked but protruding from the distal end of the case 12. Once the carrier 7 has moved in the distal direction D on skin t of the chassis 2, it is possible to s the trigger button 13 and activate the auto-injector 1. This ensures a sequenced operation.

In the embodiment of figure 18 the trigger button 13 has two proximal beams 13.1, each of them having a ramped outward boss 13.4. In the initial state shown in figure 18 the ramped outward bosses 13.4 are engaged in respective fourth recesses 12.5 in the case 12. Disengaging the ramped outward bosses 13.4 from the fourth es 12.5 is ted by the carrier 7 inwardly supporting the proximal beams 13.1 in a manner to keep the proximal beams 13.1 from deflecting ly. inward protrusions 13.5 on the proximal beams 13.1 abut against a second rib 7.10 on the carrier 7 in a manner preventing the carrier 7 from moving further in the al direction P in the initial state.

Once the carrier 7 has moved in the distal direction D on skin contact of the chassis 2 a first window 7.11 in the carrier 7 is moved behind the inward protrusion 13.5 so as to allow the proximal beams 13.1 to be inwardly deflected due to their ramped engagement in the fourth recesses 12.5 on depression of the trigger button 13. The proximal beams 13.1 are now outwardly supported by the case 12 and remain engaged to the carrier 7 even on retraction of the needle 4. The trigger button 13 does therefore not return to its initial position, indicating that the auto~injector 1 has been used.

The button release mechanism 26 illustrated in figure 18 may preferably be combined with the plunger release mechanism 27 illustrated in figure 17.

Figures 19A and 198 show two longitudinal sections of an ative embodiment of the detent ism 18. The detent mechanism 18 of figures 11A to 11D, which may be referred to as a "race track” mechanism because of the first beam head 2.2 travelling around the rhomboid ramp member 7.1 has multiple functions which control the movement of the r 7 ve to the chassis 2. The alternative detent mechanism 1O 18 of figures 19A and 19B uses three clips 7.12, 7.13, 2.6 to produce the same effect.

The first clip 7.12 is arranged as an outwardly biased resilient beam on the carrier 7 ing from the carrier 7 in the proximal direction P. the first clip 7.12 is arranged to prevent the carrier 7 from being moved in the proximal direction P prior to the chassis 2 being sed or rather the case 12 being translated on skin contact. The first clip 7.12 is composed of two sections side by side. A first section 7.14 prevents nt of the carrier 7 in the proximal direction P by abutting the chassis 2 in a recess. A second section 7.15 is arranged as an outwardly ding clip head ed to be ramped inwards by a ramp feature 12.6 on the chassis 12 for releasing the first clip 7.12 thereby ing the carrier 7 from the chassis 2 when the case 12 is being translated in the proximal direction P on skin contact. A longitudinal slot 2.7 in the chassis 2 is arranged for allowing the second section 7.15 to slide in the proximal direction P once the lock has been released. A slight friction force between the first clip 7.12 and the chassis 2 provides the retarding force required to ensure retraction.

The second clip 7.13 is ed as a resilient beam on the carrier 7 extending in the distal direction D having an outwardly protruding third beam head 7.16 with a proximal ramp. The third beam head 7.16 serves as a back stop against a third rib 2.9 on the chassis 2 for preventing the carrier 7 moving in the distal direction D from its initial position. The carrier 7 and chassis 2 are assembled with the second clip 7.13 in this position prior to inserting the syringe 3 into the carrier 7 which is facilitated by the proximal ramp on the third beam head 7.16. The syringe 3 locks the clip in place by preventing inward deflection thus creating a fixed stop.

The third clip 2.6 is a resilient beam on the chassis 2 extending in the distal direction D.

A ramped fourth beam head 2.8 on the third clip 2.6 is ed to ly engage in a fifth recess 7.17 in the carrier 7. Once the first clip 7.12 is unlocked, the user can load the third clip 2.6 by ng the carrier 7 in the proximal ion P on depression of the trigger button 13. The third clip 2.6 is loaded in compression, i.e. it will bend outwards and release suddenly due to its ramped engagement to the carrier 7 ing the detent onality similar to that illustrated in figure 11B.

Figure 20 is a udinal section of a third embodiment of the detent mechanism 18 which is a variation on the embodiment of figures 19A and 19B. In this embodiment the detent function of the third clip 2.6 has been added into the first ciip 7.12. The iock between the case 12 and the carrier 7 is released in the same way, but the detent is provided by deflecting the first clip 7.12 inwards a second level which is achieved by the chassis 2 not having a slot 2.7 for the second section 7.15. Instead the second section 7.15, once ramped inwards by the ramp feature 12.6 on the case 12 has to be further ramped inwards inside the chassis 2 on axial load between the chassis 2 and the carrier 7, suddenly releasing their engagement.

Figure 21 is a longitudinal section of an alternative ment of the feedback reiease mechanism 31. As opposed to the ck release mechanism 31 of figure 14 where the feedback spring 29 acts between the carrier 7 and the feedback component 28, in the embodiment illustrated in figure 21 the feedback spring 29 acts between the case 12 and the feedback component 28. During needle extension the ck spring 29 is compressed as the feedback component 28 moves with the carrier 7 relative to the case 12. When the feedback component 28 is released by the piunger 9 shortly before the end of dose, the feedback component 28 moves in the distal direction D and impacts the trigger button 13. Other than in figure 14 the feedback spring 29 is not being recompressed during needle retraction since it is grounded in the case 12 not in the carrier 7.

Figures 22A and 228 show longitudinal sections of an ative embodiment of the needle extension control mechanism 24 which is also arranged to perform the detent function ofthe detent mechanism 18 on needle retraction and needle extension. Figure 23 shows a corresponding isometric view. A fourth clip 20.5 on the first collar 20 is arranged as a resilient beam with a beam head having an inward al thirteenth ramp 20.6 for engaging a fourth rib 7.18 on the carrier 7 and outwardly ted by the case 12 so as to keep the first collar 20 engaged to the carrier 7 prior to use, during needle extension and during expelling the ment. When the case 12 moves in distal direction relative to the carrier, e.g. when the user lifts the case 12 away from the injection site at the end of injection, a sixth recess 12.7 in the case 12 is moved outwardly behind the fourth clip 20.5 allowing the fourth clip 20.5 to release when the carrier 7 is pulled in the distal direction D by the second collar 21. Since the fourth clip .5 has to be ramped ds a small force is required to release the fourth clip 20.5, providing the retraction detent.

A fifth clip 2.10 on the chassis 2 abuts a block 20.7 on the first collar 20 prior to use preventing the first collar 20 and hence the r 7 engaged to the ﬁrst collar 20 from moving in the proximal direction P. In orderto release, the fifth clip 2.10 must be deflected outwards and over the block 20.7. Outward deflection of the fifth clip 2.10 is lly prevented by the case 12. Once the case 12 has moved on skin contact a second window 12.8 in the case 12 appears outwardly from the fifth clip 2.10 allowing outward deflection. The fifth clip 2.10 is then ted by a fourteenth ramp 7.19 on the carrier 7 when the carrier 7 is pushed in the proximal direction P on button depression as the fourth clip 20.5 does allow ation of the carrier 7 in the proximal direction P relative to the first collar 20 but not the other way round. The detent for needle extension is provided by having to deflect the fifth clip 2.10 when it is loaded by the control spring 19.

Figures 24A and 248 show longitudinal sections of a third embodiment of the needle extension control mechanism 24, also arranged to perform the functions of the detent mechanism 18. Figure 25 is an isometric view of the needle extension control mechanism 24 of figure 24.The embodiment is similar to that illustrated in figures 22A, 228 and 23. The difference is that the fifth clip 2.10 is ed on the first collar 20 and the block 20.7 is arranged on the chassis 2, i.e. their position has been switched, so there are two clips 2.10 and 20.5 on the first collar 20.

The fourth clip 20.5 is identical to that in figure 228. it keeps the first collar 20 connected to the carrier 7 until the needle retraction is triggered, ensuring full needle extension length or depth is reached and maintained until the retraction cycle is initiated by displacing the case backwards in distal ion relative to the chassis, eg. when removing the njector 1 from the skin.

The fifth clip 2.10 provides the detent for needle extension and releases the first collar from the chassis 2, ting needle extension. The fifth clip 2.1 O prevents the first collar 20 and hence the carrier 7 engaged to the first collar 20 from moving in the proximal direction P priorto use by abutting the block 20.7 on the chassis 2. In order to e, the fifth clip 2.10 must be deflected outwards and overthe block 20.7. Outward deflection of the fifth clip 2.10 is initially prevented by the case 12. Once the case 12 has moved on skin contact the second window 12.8 in the case 12 appears outwardly from the fifth clip 2.10 allowing outward deflection. The fifth clip 2.10 is then deflected by the fourteenth ramp 7.19 on the carrier 7 when the carrier 7 is pushed in the proximal direction P on button depression as the fourth clip 20.5 does allow translation of the carrier 7 in the proximal direction P ve to the first collar 20 but not the other way round. The detent for needle extension is provided by having to deflect the fifth clip 2.10 when it is loaded by the control spring 19.

Figures 26A and 268 show a udinal section of a third ment of the feedback release mechanism 31. This embodiment works without the need for a dedicated feedback spring. The plunger 9 comprises a proximally ramped rib 9.2 arranged to splay two seventh clips 7.21 on the carrier 7 immediately prior to the end of dose. When the proximally ramped rib 9.2 has travelled past the seventh clips 7.21 they snap back and impact the plunger 9 ting a sound. The tubular shape of the carrier 7 helps to transmit the sound. Figure 26A shows the ck release mechanism 31 before release. Figure 268 shows the feedback release mechanism 31 after release. Proximal faces of the h clips 7.21 on the r 7 are y offset to facilitate assembly by lifting the seventh clips 7.21 over the distal side of the proximally ramped rib 9.2 one by one.

Figures 27A and 278 show longitudinal ns of another embodiment of the auto— injector 1 in different section planes, the ent section planes approximately 90° rotated to each other, wherein the auto-injector 1 is in an initial state prior to use. The auto—injector 1 is essentially identical to the one described in figures 1 to 16. However, other than the auto—injector of figures 1 to 16 the auto-injector1 of this embodiment has a wrap-over sleeve trigger instead of a trigger button.

The wrap-over sleeve trigger 12 is the same component as the case 12 which has a closed distal end face 12.10 other than the one in figures 1 to 16. An internal trigger button 13 is arranged at the distal end inside the sleeve trigger 12. Otherthan in figures 1 to 16 the trigger button 13 is not visible nor does it protrude from the case 12 in any state. In the initial state a clearance 33 is provided between the distal end face 12.10 of the sleeve trigger 12 and the internal trigger button 13 allowing for some travel of the sleeve trigger 12 without interfering with the trigger button 13.

As the auto-injector1 does not differfrom the auto—injector of figures 1 to 16 in other ts it is essentially operated in the same way with the following exceptions: As the chassis 2 is placed against the injection site the sleeve r 12 translates in the proximal ion P relative to the chassis 2 into the advanced position in a first phase of sleeve travel removing the clearance 33 between the distal end face 12.10 of the sleeve trigger 12 and the internal trigger button 13. As in the embodiment of figures 1 to 16 this motion unlocks the detent mechanism 18 and the trigger button 13. As the user continues to depress the sleeve trigger 12 in a second phase of sleeve travel 3O y further ing it in the proximal direction P the distal end face 12.10 hits the ai trigger button 13 thereby depressing it until the first coliar 20 is released from the chassis 2 and the control spring force is coupled on to the carrier 7. The carrier 7 then advances until the internal trigger button 13 stops on another rib in the case 12 and the plunger release mechanism 27 is released (note the peg 14 is shorter in this embodiment.

From a user perspective, the detent mechanism 18 is arranged to provide a resistive force when the user reaches the second phase of sleeve travel. internally, there is no difference to the embodiment of figures 1 to 16 at this point.

Needle extension is triggered by the user fully advancing the sleeve trigger 12 in the 1O second phase of sleeve travel thereby fully sing the internai trigger button 13 and overcoming the detent mechanism as in the embodiment of figures 1 to 16.

As the control spring 19 takes over on button depression fully advancing the carrier 7 for needle extension the internal trigger button 13 s out on an internal fifth rib 12.11 in the sleeve trigger 12 and the internal trigger button 13 switches back to being locked to the sleeve trigger 12 as in figure 160.

The embodiment of figures 27A and 278 may also be combined with the alternative features illustrated in figures 17 to 26.

It goes without saying that in all ramped engagements between two components bed in the above embodiments there may be just one ramp on one or the other ent or there may be ramps on both components t icantly influencing the effect of the ramped engagement.

List of References 1 auto-injector 2 chassis 2.1 resilient beam 2.2 first beam head 2.3 proximal third ramp 1O 2.4 distal h ramp 2.5 aperture 2.6 third clip 2.7 slot 2.8 fourth beam head 2.9 third rib 2.10 fifth ciip 2.11 sixth clip 3 synnge 4 hollow injection needle 5 protective needle sheath 6 stopper 7 carrier 7.1 ramp member 7.2 proximal fourth ramp 7.3 distal fifth ramp 7.4 carrier detent 7.5 second recess 7.6 distal tenth ramp 7.7 third recess 7.8 twelfth ramp 7.9 longitudinal aperture 7.10 second rib 7.11 first window 7.12 first clip 7.13 second clip 7.14 first section 7.15 second n 7.16 third beam head 7.17 fifth recess 7.18 fourth rib 7.19 fourteenth ramp 1O 7.20 fifteenth ramp 7.21 seventh clips drive spring plunger 9.1 ramp member 9.2 proximaliy ramped rib carrier end face 11 thrust face 12 case 12.1 first case detent 12.2 second case detent 12.3 first rib 12.4 first back stop 12.5 fourth recess 12.6 ramp feature 12.7 sixth recess 12.8 second window 12.9 third window 12.10 distal end face 12.11 fifth rib 13 trigger button 13.1 proximal beam 13.2 outward first ramp 13.3 inward second ramp 13.4 ramped outward boss 13.5 inward protrusion 13.6 second back stop 14 peg resilient arm 16 first recess 17 distal plunger sleeve 18 detent ism 1O 19 control spring first collar .1 arrowhead .2 outward sixth ramp .3 inward ninth ramp 20.4 tab .5 fourth clip .6 inward proximal thirteenth ramp .7 block .8 fifth clip 21 second collar 21.1 proximal beam 21.2 second beam head 21.3 inward boss 21.4 distal outward eighth ramp 21.5 longitudinal rib 22 cap 22.1 inner sleeve 23 barb 24 needle extension control ism 25 syringe retraction control mechanism 26 button release mechanism 27 plunger release mechanism 28 feedback component 28.1 elongate portion 28.2 distal end plate 28.3 outward eleventh ramp 29 feedback spring second resilient arm .1 ramped inward boss 31 feedback release mechanism 32 tor window ’10 33 clearance distal end, distal direction inward direction medicament TOE outward direction al end, proximal direction

Claims

THE CLAIMS DEFINING THE INVENTION ARE AS FOLLOWS:

1. Auto-injector for administering a dose of a liquid medicament. comprising: — a tubular chassis telescopable in a r case, — a carrier subassembly comprising a tubular r slidably arranged relative to the chassis inside the case, the carrier adapted to contain a syringe with a hollow injection needle, a drive spring and a plunger for forwarding load of the drive spring to a stopper of the syringe, wherein the syringe is lockable for joint axial translation with the carrier, - a trigger button arranged distally or laterally in or on the case, - a control spring arranged around the carrier, 10 - a needle extension control mechanism for coupling a proximal end of the control spring to either the carrier for advancing it for needle extension or to the s for needle retraction ing on the relative axial position of the carrier and the chassis. - a plunger release mechanism arranged for releasing the plunger for expelling the medicament when the carrier has at least almost reached an extended proximal position, 15 - a detent mechanism arranged for coupling the chassis to the r for joint axial translation relative to the case, wherein the detent mechanism is arranged to decouple the s from the carrier upon actuation of the r button thus allowing the carrier to move relative to the chassis so as to cause the needle extension control ism to switch the proximal end of the control spring to the r for needle extension, 20 - a syringe retraction control mechanism arranged for coupling a distal end of the control spring to either the carrier for needle retraction or to the case othenivise.

2. Auto—injector according to claim 1, characterized in that the needle extension control mechanism comprises a first collar biased by the control spring in a proximal direction, wherein at least one resilient beam is proximally ed on the first collar, 25 wherein respective es are arranged in the carrier and case, wherein a ersal extension of a head of the resilient beam is wider than a gap between the carrier and the chassis causing the head of the resilient beam to abut a distal face on the recess in the chassis while being prevented from deflecting in an inward direction by the carrier or to abut a distal face on the recess in the carrier while being prevented from deflecting in an 30 outward direction by the chassis thereby fonlvarding load from the control spring to the r for needle ion. wherein the resilient beam is arranged to be switched between the s and the r by ramped engagement of the head to the distal faces under load of the control spring depending on the ve longitudinal position between the chassis and the carrier.

3. Auto-injector according to claim 1 or 2, characterized in that the plunger release mechanism comprises at least one resiiient arm on the carrier arranged to be in a ramped engagement to the plunger so as to age them under load of the drive spring, wherein a peg protrudes from a distal end face of the trigger button in the proximal direction in a manner to support the resilient arm preventing disengagement of the carrier from the plunger and thus release of the drive spring when the carrier is in a distal position, wherein the r button is arranged to remain in position ve to the 10 case when the carrier is translated for advancing the needle so as to pull the resilient arm away from the peg thus allowing deflection of the ent arm due to the ramped engagement under load of the drive spring for disengaging the plunger from the r and releasing the drive spring for movement of the plunger when the carrier has reached a predefined position relative to the case. 15

4. Auto-injector according to any one of the preceding claims, characterized in that the detent mechanism is arranged to e a resistive force which has to be overcome to advance the carrier in the proximal direction for needle extension.

5. Auto-injector according to any one of the preceding claims, characterized in that the detent mechanism is arranged to provide a resistive force resisting translation of the 20 carrier in the distal direction relative to the chassis for keeping the carrier in a defined position in a transitional state with both ends of the control spring decoupled from the carrier.

6. njector according to claim 4 or 5. characterized in that the detent mechanism comprises a resilient beam on the chassis and a id ramp member on 25 the r, the resilient beam being essentially straight when relaxed and having a first beam head arranged to interact in a ramped engagement with a al fourth ramp or a distal fifth ramp on the rhomboid ramp member in such a manner that application of a translative force on the carrier relative to the chassis in the proximal direction with the first beam head engaged to the fourth ramp deflects the resilient beam in one transversal 30 direction when a predetermined value of the translative force, at least depending on the resilience of the resilient beam, is overcome so as to allow the first beam head to travel along one transversal side of the rhomboid ramp member on continued relative translation of the components, n the resilient beam is allowed to relax when the first beam head has reached the fifth ramp thereby engaging it in a manner that application of a translative force on the carrier in the distal direction deflects the resilient beam in the other transversal direction when a predetermined value of the translative force, at least depending on the resilience of the resilient beam, is overcome so as to allow the first beam head to travel along the other transversal side of the rhomboid ramp member on continued translation of the carrier.

7. Auto-injector ing to any one of the preceding Claims, characterized in that 10 the case is arranged to lock the detent mechanism prior to being translated in the ai direction relative to the chassis when the chassis is being pressed against an injection site, wherein the case when translated into an advanced position in the proximal direction is ed to unlock the detent mechanism rendering it operable.

8. Auto-injector according to any one of the preceding claims, characterized in that 15 the ly arranged trigger button is at least initially d to the carrier, wherein the case is arranged to abut the trigger button in the initial state preventing depression of the trigger button, n on translation of the case into the advanced position when the chassis is being pressed against the injection site the trigger button remains coupled to the carrier thus emerging from the case so as to allow depression for starting an injection 20 cycle.

9. Auto-injector according to any one of the ing claims, characterized in that the syringe retraction control mechanism comprises a second collar bearing against the distal end of the control spring and having a resilient proximal beam with a second beam head having an inward boss, wherein the second beam head is arranged to be in a 25 ramped engagement with a second case detent in the case in a manner ramping the second beam head in the inward direction under load of the control spring in the distal direction, wherein the inward boss is arranged to inwardly abut the carrier for preventing inward deflection of the second beam head and keep the second coliar locked to the case, wherein a third recess is ed in the carrier for ng the inward boss to be 30 ly deflected on translation of the case in the distal ion relative to the carrier on removal of the auto-injector from the injection site.

10. Auto—injector ing to any one of the preceding claims, characterized in that the trigger button is arranged distally, wherein the case is arranged as a wrap-over sleeve trigger having a closed distal end face covering the trigger button, wherein in an initial state a clearance is provided between the distal end face of the sleeve trigger and the trigger button allowing for some travel of the sleeve trigger against the bias of the control spring in the proximal direction in a first phase before abutting the trigger button.

11. Auto-injector according to any one of the preceding claims, characterized in that a releasable feedback component is provided, capable of, upon release, generating an audible and/or tactile feedback to a user, n the feedback component is arranged to 10 be released when the plunger reaches a position relative to the syringe in which the stopper is located in proximity of a proximal end of the syringe, and n the released feedback component impacts on a housing component indicating the end of the injection.

12. Auto—injector according to any one of the claims 2 to 11, characterized in that a visual use indicator is provided, comprising at least one indicator window in the case, 15 wherein a part of the chassis is arranged to be located behind the indicator window when the case is in its distal position biased by the control , wherein a tab on the first collar is located outwardly from the part of the chassis after the collar has been translated in the proximal direction during needie extension, wherein the tab and the part of the chassis exhibit a visually distinctive feature. 20

13. Method of operating an auto—injector, the auto—injector comprising: - a tubular s opable in a r case, ~ a r subassembly comprising a tubular carrier slidably arranged relative to the s inside the case, the r adapted to contain a syringe with a hollow ion needle, a drive spring and a plunger for forwarding load of the drive spring to a stopper of 25 the syringe, wherein the syringe is lockable for joint axial translation with the carrier, - a trigger button arranged distally or laterally in or on the case, - a control spring arranged around the carrier, - a needle ion control mechanism for coupling a proximal end of the control spring to either the carrier or to the chassis, 30 - a plunger e mechanism arranged for locking the drive spring, - a detent mechanism arranged for ng the chassis to the carrier, ~ a syringe tion control mechanism arranged for coupling a distal end of the control spring to either the carrier or to the case, the method comprising the steps of: — coupling the proximal end of the control spring to the carrier by the needle extension control mechanism, preventing release of the drive spring by the plunger release mechanism, preventing decoupling of the chassis from the carrier by the detent mechanism and coupling the distal end of the control spring to the case by the syringe retraction control mechanism in an initial state, - ating the case in the proximal direction relative to the chassis t the force of the control spring 1O ~ unlocking the detent mechanism when the case is translated into an advanced position y allowing translation of the carrier relative to the chassis - translating the carrier in the proximal direction thereby switching the needle extension control mechanism so as to decouple the proximal end of the control spring from the chassis and couple it to the carrier, thereby releasing the control spring for ing the 15 carrier for needle extension, - releasing the drive spring by the plunger release mechanism when the needle at least almost reaches an extended proximal position thereby allowing the drive spring to advance the plunger and the stopper for at least partially expeliing the medicament. - ating the case in the distai direction under load of the control spring relative to the 20 carrier - decoupiing the al end of the control spring from the carrier and coupling it to the s by the needle extension l mechanism and decoupling the distal end of the control spring from the case and coupling it to the carrier by the syringe retraction control mechanism when the case reaches a defined position relative to the carrier during 25 translation in the distal direction, - retracting the carrier subassembly into the s into a needle safe position under load of the control .

14. Method according to claim 13, characterized in that a resistive force is provided by the detent mechanism which has to be overcome to advance the carrier in the 30 proximal direction for needle extension.

15. Method according to claim 13 or 14, characterized in that a resistive force is provided by the detent mechanism resisting ation of the carrier in the distal direction relative to the chassis for keeping the r in a defined on after decoupling the proximal end of the controi spring from the carrier and coupling it to the chassis by the needle extension control mechanism and before decoupling the distal end of the control spring from the case and coupling it to the carrier by the syringe retraction controi mechanism.

16. Method according to any one of claims 13 to 15, wherein the auto—injector is the auto-injector ing to any one of the claims 1 to 12.

17. njector for administering a dose of a liquid medicament, the auto-injector substantially as herein described with reference to any embodiment shown in the accompanying drawings; 1O

18. Method of operating an auto-injector, the method ntially as herein described with reference to any embodiment shown in the accompanying drawings.