WO2026017289A1 - Autoinjector comprising a locking sleeve - Google Patents

Abstract

The invention relates to an autoinjector for dispensing a liquid product, comprising a housing (2) and a blocking sleeve (7), with a locking device being provided on the blocking sleeve (7) and on a mechanism holder (5; 5'; 5'') fixed to the housing. The locking device is used to lock a needle-protection sleeve (3) in a needle-protection position, wherein, in the needle-protection position, the needle-protection sleeve (3) is locked relative to the mechanism holder (5; 5'; 5'') against being pushed back in the proximal direction in such a way that a needle tip of a needle (11a) cannot protrude out of the distal end of the needle-protection sleeve (3).

Description

Auto-injector with a locking sleeve

The invention relates to an autoinjector, often also referred to as an autoinjection device, with which a product contained in a product container can be automatically dispensed after triggering. The liquid product is, in particular, a pharmaceutical drug. Specifically, the invention relates to an autoinjector with a locking sleeve, wherein the autoinjector cannot be triggered again after a first triggering.

The term "medicinal product" here encompasses any flowable medical formulation suitable for controlled administration through a means such as a cannula or needle, in particular a hollow needle, comprising, for example, a liquid, a solution, a gel, or a fine suspension containing one or more medicinal active ingredients. A medicinal product may be a composition with a single active ingredient or a premixed or co-formulated composition with multiple active ingredients from a single container. The term "medicine" encompasses drugs such as peptides (e.g., insulins, insulin-containing drugs, GLP-1-containing and derived or analogous preparations), proteins and hormones, biologically derived or active substances, hormone- or gene-based drugs, nutritional formulations, enzymes (e.g., hydrolases, lyases) and other substances in both solid (suspended) or liquid form, as well as polysaccharides (e.g., glycosaminoglycans), vaccines, DNA or RNA or oligonucleotides, antibodies or parts of antibodies, and suitable base, excipient, and carrier substances.

Autoinjectors are known from the prior art, as from EP2742962B2, to deliver an injection simply and safely using a pre-tensioned spring, whereby no further injection can be delivered after the injection has been delivered.

It is an object of the invention to provide an alternative autoinjector which, after delivering an injection, does not allow any further delivery.

The problem is solved with the autoinjector according to claim 1. Advantageous further developments result from the dependent claims, the description and the figures.

The autoinjector according to the invention comprises a housing and a product container arranged in the housing. The product container can, in particular, be a syringe having a syringe body at the distal end of which a needle is fixedly arranged. The preferably cylindrical syringe body surrounds a piston that is displaceable relative to the syringe body and is moved towards the distal end for product dispensing, thereby creating space between the piston and the syringe body. and the liquid product, especially medication, is dispensed from the product container through the needle. The syringe body may have a flange at its proximal end, i.e., the rear end or the end opposite the needle, which can also be called a finger flange. Syringes designed in this way are available as standard syringes, so it is not absolutely necessary to develop a specially adapted syringe for the autoinjector. The plunger seals against the inner diameter of the syringe body.

The housing is preferably elongated and forms the longitudinal axis of the autoinjector. The housing is preferably sleeve-shaped and/or cylindrical, in particular circular cylindrical or oval. The product container is arranged within the housing. For example, the container can be slidably arranged within the housing, i.e., it can be moved distally relative to the housing for automatic insertion, so that the needle tip emerges from an opening at the distal end of the autoinjector and can be automatically inserted into the patient. Optionally, in such a device, the needle tip can be moved into the distal end of the device after product dispensing, and in particular, the product container can be moved proximally relative to the housing.

In preferred embodiments, the product container is fixedly mounted in the housing along its longitudinal axis, particularly by means of a product container holder or syringe holder that axially secures the product container or syringe and is axially fixed to the housing, especially by a locking mechanism. Preferably, the needle tip extends distally beyond the distal end of the housing. This allows the needle to be inserted into the injection site by moving the housing towards the patient. Preferably, a needle guard is provided, which forms the distal end of the autoinjector and has an opening for the needle, through which the needle can pass. The needle guard is preferably arranged so that it is rotationally fixed relative to the housing and axially movable. In its initial position relative to the needle tip, the needle guard can be positioned such that the needle guard extends distally beyond the needle tip or that the needle tip extends distally beyond the distal end of the needle guard. The needle guard sleeve is displaceable relative to the housing from its initial position in the proximal direction by one actuation stroke into an actuated position, in particular into the housing, so that the needle protrudes or protrudes further from the distal end or through the opening of the needle guard sleeve. Preferably, the needle guard sleeve can be displaced from the actuated position relative to the housing by one needle guard stroke in the distal direction into a needle guard position in which the distal end of the needle guard sleeve extends distally beyond the needle tip, in order to prevent any risk of injury from an exposed needle tip after use of the device or after product dispensing. The needle guard sleeve is held in place, for example, against the force of a needle guard spring. The needle guard spring can move the needle guard sleeve from the actuated position into the distal position, i.e., into the needle guard position. The actuating stroke and the needle guard stroke of the needle guard sleeve can be the same length or different lengths.

The needle guard spring acts on the needle guard sleeve, which, for triggering product dispensing, is displaceable from its initial position relative to the housing and along the longitudinal axis of the autoinjector in the proximal direction, i.e., opposite to the dispensing direction, particularly by the actuation stroke. This tensions the needle guard spring and preferably also triggers product dispensing, in particular the movement of the propellant in the dispensing direction. The needle guard sleeve is preferably moved from its initial position by the actuation stroke into its actuated position by pressing its distal end against the patient's injection site, whereby the housing is displaced relative to the needle guard sleeve in the direction of the injection site, so that the needle guard sleeve executes the actuation stroke relative to the housing. In this process, the needle protruding from the distal end of the needle guard sleeve is also inserted into the injection site. After the product dispensing has occurred, particularly after, for example, a short waiting period, such as... For example, 3 to 10 seconds after a dispensing signal has been generated, or alternatively, after no dispensing signal has been generated or the dispensing signal has ceased, the autoinjector is removed from the injection site. This causes the needle guard sleeve to move relative to the housing from its actuated position by the needle guard stroke into the needle guard position, primarily by means of the spring energy stored in the needle guard spring. Removing the autoinjector from the injection site also pulls the needle out of the injection site.

The needle guard spring can, for example, be a torsion spring acting as a compression spring. The needle guard spring is preferably made of metal. The needle guard spring can be supported at its proximal end, for example, on the housing or on a housing-fixed element, in particular on a housing-fixed end cap. The end cap is arranged, in particular, at the proximal end of the housing. The end cap can close the proximal end of the sleeve-shaped housing. The end cap is axially fixed, in particular axially and rotationally fixed, to the housing. Particularly preferably, the needle guard spring is supported at its distal end on the needle guard sleeve or on an element that is displaced with the needle guard sleeve, especially when the needle guard sleeve is displaced relative to the housing. For example, the element can be a locking sleeve, as described below. The element can be arranged, in particular, kinematically and/or geometrically between the needle guard sleeve and the needle guard spring, especially at the distal end of the needle guard spring. The advantage here is that the needle guard sleeve can be moved from its actuated position to the needle guard position by means of the needle guard spring. The needle guard spring can therefore preferably fulfill a dual function, as it also exerts the aforementioned force on the locking sleeve.

The autoinjector may have a locking device that locks the needle guard sleeve in its needle guard position, particularly relative to the housing, and prevents the needle guard sleeve from being pushed back in the proximal direction or into the housing. The locking device ensures that, in the needle guard position, the needle guard sleeve is locked relative to the housing against being pushed back in the proximal direction, preventing the needle tip from protruding from the distal end of the needle guard sleeve. The locking device preferably comprises a spring-loaded or elastically arranged locking element and a corresponding locking stop. The locking device locks the needle guard sleeve at least to such an extent that the needle cannot protrude from the distal end of the needle guard sleeve. For example, the needle guard sleeve can only be moved from the needle guard position in the proximal direction to the extent that the needle tip does not protrude from the distal end of the needle guard sleeve.

The autoinjector further comprises a drive element that acts on the piston, particularly bearing against the piston, at least during product dispensing, and a discharge spring that acts on the drive element, for example, by bearing against it at its distal end. The drive element can, for example, be sleeve-shaped. The discharge spring is preferably arranged inside the sleeve-shaped drive element. Alternatively, the discharge spring can be arranged outside the sleeve-shaped drive element. The discharge spring is preferably a torsional spring acting as a compression spring, preferably made of metal. The discharge spring is pre-tensioned to such a high degree, particularly in the delivery state or in the initial position of the autoinjector, that it, or the energy stored in it, is sufficient to dispense the product from the product container essentially completely by moving the drive element by one discharge stroke. The displacement of the drive element by the discharge stroke also moves the piston. If a gap exists between the piston and the actuator in the as-delivered or initial position, the piston's discharge stroke is smaller than the actuator's discharge stroke. This is preferred because the piston remains unloaded until use, thus preventing unwanted premature product discharge. However, it is also possible for the actuator to be in contact with the piston in the as-delivered or initial position, rather than only during product discharge. If the actuator is already in contact with the piston in the as-delivered or initial position, the piston's discharge stroke corresponds to the actuator's discharge stroke. The discharge stroke of the actuator and the piston can be the same length or different lengths. The proximal end of the discharge spring can be supported by the housing or by a housing-mounted element, particularly the autoinjector's end cap. The housing or the housing-mounted element, in particular the end cap, can have a guide so that the discharge spring is pre-tensioned and/or relaxed, guided or supported, preventing the discharge spring from buckling. This guide projects through the interior of the discharge spring.

In preferred embodiments, the autoinjector can have an adapter which is arranged inside, and in particular axially movable within, the drive element. The adapter can serve, on the one hand, to adjust the distance between the drive element and the piston during assembly of the autoinjector, in particular to reduce it, since the piston is located at different positions within the syringe due to the different filling volumes. For this purpose, the adapter can have teeth that engage with mating teeth arranged on the drive element, whereby the distance between the piston in the syringe and the adapter can be adjusted by an axial relative movement between the adapter and the drive element. Alternatively, instead of using an additional adapter, the distance between the piston in the syringe and the drive element can be achieved by axial positioning between the drive element and the housing or a housing-mounted element, in particular a housing-mounted mechanical holder. The drive element and the housing or mechanical holder can have teeth and corresponding mating teeth to adjust the distance between the syringe piston and the drive element. Furthermore, the energy of the axially movable drive element can be absorbed or reduced by the adapter when the dispensing process begins. The adapter reduces the risk of glass breakage, which occurs when the drive element impacts the piston with a sudden force at the start of the dispensing process. This energy is at least partially absorbed by the friction between the adapter and the syringe body when the adapter strikes the piston inside the syringe. For this purpose, the adapter can have a thread and the drive element a mating thread, with the thread and mating thread engaging and designed such that the adapter and drive element are axially movable relative to each other until they lock. Alternatively, the adapter and/or the drive element can have one or more pinch elements or counter-pinch elements, or be designed as a pinch element or counter-pinch element. Preferably, the pinch element is designed such that the impact energy of the drive element on the piston is at least partially absorbed by the pinch of the pinch element being compressed by the counter-pinch element. Alternatively, the adapter and the drive element can have teeth and counter-teeth to at least partially absorb the kinetic energy of the drive element. This creates a damping effect between the piston and the drive element.

In the delivered state or in the starting position, there may be a gap between the piston and the adapter, so that the piston's discharge stroke is smaller than the discharge stroke of the drive element. Alternatively, the adapter can be in contact with the piston in the delivery state or in the starting position, and not only during product dispensing, so that the dispensing stroke of the piston and the dispensing stroke of the drive element are the same.

The mechanical holder is axially fixed relative to the housing, in particular axially and rotationally fixed. The mechanical holder is preferably sleeve-shaped. Particularly preferably, the distal end of the mechanical holder is designed as a retaining spring and serves to pre-tension the product container, in particular the syringe, in the product container holder, especially the syringe holder, in the distal direction in order to compensate for possible length tolerances of the product container, in particular the syringe.

The product container is preferably designed as a syringe and is held in the product container holder, particularly preferably in the syringe holder. The syringe comprises the syringe body, the plunger, and the needle, wherein the needle is, for example, permanently attached to a needle retaining section of the syringe, and the plunger is slidably arranged in the cylindrical section of the syringe body. The syringe body further comprises a tapered section located between the needle retaining section and the cylindrical section. The syringe also includes a needle shield, which can be, for example, a so-called soft needle shield or, preferably, a rigid needle shield. A soft needle shield is preferably made of a rubber-elastic plastic, while a rigid needle shield consists of a sleeve made of rigid plastic in which a sleeve made of a rubber-elastic plastic is arranged. The sleeve made of rubber-elastic plastic and the sleeve made of rigid plastic together form the rigid needle shield. The needle guard, which covers the needle, is detachably attached to the needle holder section and preferably keeps the needle protected from dirt and sterile. A gap is also formed between the syringe body, particularly the tapered section of the syringe body, and the needle guard.

The syringe holder has at least one engagement element, in particular a shoulder, against which the tapered section of the syringe rests in the distal direction and which engages in the gap between the needle guard and the tapered section. Advantageously, the contact of the tapered section with the engagement element prevents the syringe from moving distally relative to the syringe holder. Furthermore, the pre-tensioning of the mechanical holder, in particular its retaining spring, in the distal direction ensures a secure fit of the syringe against the engagement element.

The housing or needle guard sleeve of the autoinjector may preferably have a retaining section that rests against the syringe holder, in particular against an outer surface or outer circumference of the syringe holder, and prevents the engagement element of the syringe holder from moving transversely to the longitudinal axis. to move away from the longitudinal axis. In particular, the retaining section can be cylindrical and preferably surrounds the engagement element. For mounting or inserting the syringe into the syringe holder, the syringe holder is outside the engagement with the retaining section of the housing or the needle guard sleeve. When the syringe is fully inserted into the syringe holder, and in particular when the engagement element engages in the gap between the tapered section and the needle guard cap, the syringe holder, which holds the syringe, is brought into engagement with the retaining section, thus preventing the engagement element from moving out of engagement with the tapered section transversely to the longitudinal axis, in particular away from the longitudinal axis or outwards.

The engagement element can be resilient or elastic, in particular formed on an arm of the syringe holder. The syringe is inserted into the syringe holder, which is preferably sleeve-shaped, via its proximal end with the needle first. The needle guard deflects the engagement element outwards, i.e., away from the longitudinal axis, and when the needle guard has moved completely past the engagement element, the engagement element snaps into the gap between the tapered section and the needle guard. Subsequently, the syringe holder with the syringe is moved into engagement with the retaining section of the housing or needle guard sleeve of the autoinjector, thereby holding the engagement element in the gap between the needle guard and the tapered section and preventing it from springing out of this engagement.

In order for the user to use the autoinjector, the user must remove a pull-off cap provided at the distal end of the autoinjector from the housing or needle guard sleeve when the autoinjector is in its original delivery state.

In its delivered state, the needle is covered by a needle shield to protect it from contamination and to maintain the sterility of both the needle and the medication. The needle shield is positioned on the needle-holding section of the syringe barrel, with the tapered section of the syringe barrel located between the needle-holding section and the cylindrical section of the syringe barrel. The engagement element is positioned between the syringe barrel, particularly the tapered section of the syringe holder, and the needle shield, specifically such that a small gap exists between the needle shield and the engagement element to prevent the engagement element from exerting force on the needle shield, which could compromise the sterility of the needle or the medication. The pull-off cap is detachably snapped onto the housing or the needle shield sleeve, and this snap-off is released when the pull-off cap is removed from the housing or the needle shield sleeve. The pull-off cap includes a snap hook that engages in the gap between the syringe body, specifically its tapered section, and the proximal end of the needle shield. When the pull-off cap is removed from the autoinjector... When the snap hook is released, it engages the proximal end of the needle guard cap, thereby detaching the needle guard cap from the syringe and removing it, along with the cover cap, from the autoinjector. Alternatively, the snap hook can engage a lateral surface of the needle guard cap. In preferred embodiments, a small gap is also provided between the needle guard cap and the snap hook in the delivered state to prevent the snap hook from exerting force on the needle guard cap, which could, for example, compromise the sterility of the needle or the medication.

In alternative embodiments, the pull-off cap may have an elastic, snap-on or clampable element instead of a snap hook, which can grip around, on or into the needle guard cap in order to pull or twist off the needle guard cap from the syringe.

To initiate product dispensing, the needle guard sleeve is moved relative to the housing and along the longitudinal axis of the autoinjector in the proximal direction. Since the locking sleeve is positioned between the needle guard spring and the needle guard sleeve, the locking sleeve is carried along by the needle guard sleeve in the proximal direction when the needle guard sleeve is moved from its initial position in the proximal direction or into the actuated position. Additionally, the needle guard sleeve is moved distally when the needle guard spring acting on the locking sleeve moves it distally. The locking sleeve and the needle guard sleeve can preferably be designed as separate elements. The locking sleeve can be axially fixed and rotatable to the needle guard sleeve, for example, by being rotatably snapped in place, or the locking sleeve and the needle guard sleeve can be loosely connected.

The housing or mechanical holder may have an engagement cam which engages the drive element before the product discharge is triggered, thereby preventing the drive element from moving relative to the housing or mechanical holder in the discharge direction. The discharge spring is held under preload in the drive element when the engagement cam of the housing or mechanical holder is engaged or coupled with the drive element. The engagement cam may be provided on a spring-loaded or elastic arm of the housing or mechanical holder. Alternatively, the engagement cam may be spring-loaded or elastic. The engagement or coupling of the engagement cam with the drive element can be released for product discharge. When the engagement or coupling is released, the drive element is free to move in the discharge direction. The discharge spring can displace the drive element relative to the housing or mechanical holder by the discharge stroke in the discharge direction. The discharge spring can relax. The drive element can have a recess for the engagement cam of the housing or the mechanical holder, with this coupling between the drive element and the housing or the mechanical holder. The engagement cam is released when the housing or mechanical holder, in particular the engagement cam, is disengaged from the engagement or coupling with the drive element, especially from the recess of the drive element. In particular, the engagement cam can be released from engagement or coupling with the drive element by moving the needle guard sleeve from its initial position by the actuating stroke into the actuated position. For example, the engagement cam can be held in axially fixed engagement or coupling with the drive element by the needle guard sleeve or the locking sleeve when the needle guard sleeve is not in its actuated position or in its initial position. For example, an inner circumference of the needle guard sleeve or an inner circumference of the locking sleeve can hold the engagement cam in engagement or coupling with the drive element, whereby the engagement cam can bear against the inner circumference of the needle guard sleeve or the inner circumference of the locking sleeve.

By moving the needle guard sleeve into its actuated position, the needle guard sleeve or the locking sleeve can allow the engagement cam of the housing or the mechanical holder to disengage from engagement or coupling with the drive element, particularly with a movement transverse to the longitudinal axis of the autoinjector. For example, a recess can be provided on the needle guard sleeve or on the locking sleeve, which is positioned axially on the needle guard sleeve or on the locking sleeve such that, in the actuated position of the needle guard sleeve, the engagement cam can disengage from engagement or coupling with the drive element and/or transversely to the longitudinal axis into the recess.

To prevent the needle guard sleeve from being pushed back after the product has been poured, so that at least the needle tip does not protrude from the distal end of the needle guard sleeve, the locking device of the autoinjector can preferably be provided on the locking sleeve and on a housing-fixed element, in particular the mechanical holder, the housing or the end cap.

The locking device of the autoinjector is preferably provided on the locking sleeve and the mechanical holder. For this purpose, the locking sleeve can comprise the spring-loaded or elastically arranged locking element, and the mechanical holder can have the corresponding locking stop. Alternatively, the spring-loaded or elastically arranged locking element can be provided on the mechanical holder, and the corresponding locking stop can be arranged on the locking sleeve.

In its initial position or as delivered, the locking sleeve is arranged to be rotationally fixed relative to the mechanical holder. In preferred embodiments, a releasable anti-rotation device can be provided on the locking sleeve and on the mechanical holder. Alternatively, the anti-rotation device can be The anti-rotation device can be provided on the housing or on the end cap and the locking sleeve. It can be designed as an engagement or as a coupling between a rib and a first groove. In its initial position or as delivered, the anti-rotation device prevents rotation between the locking sleeve and the mechanism holder. The mechanism holder can have the rib, and the locking sleeve the first groove. Alternatively, the rib can be on the locking sleeve, and the first groove on the mechanism holder.

Since the locking sleeve and the needle guard sleeve are axially fixed or loosely connected, moving the needle guard sleeve into its actuated position can also move the locking sleeve in the proximal direction. This releases the anti-rotation device between the locking sleeve and the mechanism holder, as the first groove of the locking sleeve and the rib disengage from their engagement or coupling. When the anti-rotation device between the locking sleeve and the mechanism holder is released, the locking sleeve can rotate relative to the mechanism holder. The anti-rotation device is released, at least in the actuated position of the needle guard sleeve. Furthermore, moving the needle guard sleeve into its actuated position can disengage the engagement cam of the mechanism holder or the housing from its engagement or coupling with the recess of the drive element. This allows the drive element to be moved distally by the pre-tensioned force of the discharge spring, dispensing the product from the product container, particularly the syringe. Preferably, the locking sleeve can have a recess so that the engagement cam is radially movable outwards to disengage from or disengage from the drive element. Particularly preferably, the engagement cam is arranged on the resilient or elastic arm, or is resiliently or elastically designed, to be movable transversely to the longitudinal axis of the autoinjector and/or radially outwards.

In preferred embodiments, the locking sleeve and the mechanism holder can engage or couple, wherein this engagement or coupling is designed such that the locking sleeve rotates relative to the mechanism holder when the needle guard sleeve is moved relative to the mechanism holder into the needle guard position, wherein in the needle guard position a locking mechanism between the locking sleeve and the mechanism holder locks the needle guard sleeve relative to the mechanism holder against being pushed back in the proximal direction, preventing the needle tip from protruding from the distal end of the needle guard sleeve. Alternatively, this engagement or coupling can be provided between the housing or end cap and the locking sleeve.

The spring-loaded or elastic arm or the spring-loaded or elastic engagement cam can have a guide cam. The engagement cam or the arm of the engagement cam can have the guide cam, which is engaged by the disengagement movement of the engagement cam from the drive element into engagement. or can engage with a guide cam on the locking sleeve. The guide cam can be arranged transversely to the longitudinal axis of the autoinjector and/or radially outwardly movable. The guide cam can be located, for example, on the spring-loaded or elastic arm on which the engagement cam is arranged. The engagement or coupling between the guide cam and the guide cam can form a cam control, in particular a rotary guide. The engagement cam and the guide cam can be coordinated such that the cam control, in particular the rotary guide between the locking sleeve and the mechanical holder or the housing, is already engaged or coupled when the engagement cam has not yet completely disengaged from the drive element. The engagement cam and the guide cam can be coordinated such that the guide cam already engages or couples with the guide cam of the locking sleeve when the engagement cam has not yet completely disengaged from the drive element. This advantageously ensures that the engagement or coupling between the locking sleeve and the housing or the mechanical holder is established before the axially fixed connection between the housing or the mechanical holder and the drive element is released, thus preventing the needle guard sleeve from being pushed back again or further. Particularly when the guide cam is in its guide groove, the drive element can move distally relative to the housing or the mechanical holder, especially due to the energy stored in the discharge spring. The drive element can prevent the guide cam from disengaging from the engagement or coupling with the locking sleeve when the drive element moves distally relative to the housing or the mechanical holder. This preferably also applies at the end of the discharge stroke. The drive element holds or presses the guide cam, especially the guide cam of the housing or the mechanical holder, into the guide groove, particularly into the guide groove of the locking sleeve, during and at the end of the discharge stroke.

Preferably, the engagement cam and the guide cam are formed on a common resilient or elastic arm, with the engagement cam pointing, e.g., radially towards the longitudinal axis and the guide cam pointing, e.g., radially away from the longitudinal axis. The engagement cam and the guide cam can be arranged, preferably radially, between the drive element and the needle guard sleeve or the locking sleeve.

The guide cam can engage or couple with a guide cam provided on the locking sleeve by means of a radial deflection of the engagement cam outwards. The engagement or coupling between the guide cam and the guide cam is designed as a cam control, in particular as a rotational guide. At the end of the product dispensing, the patient can remove the autoinjector from the injection site. During this process, the needle guard sleeve and the locking sleeve move distally. Due to the engagement between the guide cam of the housing or the mechanical holder and the guide cam of the locking sleeve, the locking sleeve can move into the In the distal direction, the locking sleeve rotates relative to the housing or the mechanism holder. The engagement cam is held in engagement or coupling with the guide cam by the drive element. During or after the rotation of the locking sleeve relative to the housing or the mechanism holder, the guide cam can align axially with the first groove. Additionally, during or after the rotation of the locking sleeve relative to the housing or the mechanism holder, the rib can align axially with a second groove. The second groove can be provided on the locking sleeve, the housing, or the mechanism holder. By engaging the rib in the second groove, the needle guard sleeve can be moved relative to the housing from its actuated position by the needle guard stroke into the needle guard position, particularly by means of the spring energy stored in the needle guard spring. Furthermore, the relative rotation between the locking sleeve and the mechanism holder or the housing brings the spring-loaded or elastically arranged locking element and the corresponding locking stop into axial alignment. During the movement of the needle guard sleeve and the locking sleeve in the distal direction, particularly into the needle guard position, the spring-loaded or elastically arranged locking element and the corresponding locking stop enter a locking position. Upon subsequent movement of the needle guard sleeve and the locking sleeve in the proximal direction, the spring-loaded or elastically arranged locking element and the corresponding locking stop reach a stop contact, particularly an axial stop contact, thus preventing further movement of the needle guard sleeve and the locking sleeve relative to the housing in the proximal direction.

Alternatively, the guide cam can be located on the locking sleeve and the guide cam on the mechanical holder.

In preferred embodiments, the thrust member can have one or more signal elements. The signal element can be provided on a resilient or elastic arm of the thrust member or be resilient or elastic itself. The signal element can be designed as a radially outwardly projecting projection. The mechanical holder, the end cap, or the housing can have several openings along the longitudinal axis of the autoinjector. These openings are arranged at even or uneven intervals along the longitudinal axis of the autoinjector. The signal element is preferably provided at a proximal end or in a proximal region of the thrust member. If several signal elements are provided, the signal elements can be arranged at even or uneven intervals along the longitudinal axis of the thrust member or in the direction of travel of the thrust member. The positioning of the signal element and the positioning of the openings along the longitudinal axis of the autoinjector are coordinated in such a way that the signal element is in contact with the openings of the mechanical holder during the entire and at least partial discharge stroke of the piston or the actuator element. The cap or housing interacts in such a way as to generate a dispensing signal, in particular an acoustic, haptic, and/or visual signal. This ensures that the patient is notified that the dispensing process is underway or in progress during the entire or at least partial dispensing stroke of the piston or propulsion element. The dispensing signal can be generated continuously, with acceleration, or with a delay during the dispensing process. The dispensing signal can be a rattle or click, in particular a repeated rattle or click. Alternatively or additionally, the housing and/or the mechanical holder can have a viewing window to detect the movement or position, in particular the continuous movement or position, of the signaling element. Alternatively or additionally, the autoinjector can vibrate during product dispensing. Furthermore, the autoinjector can include an amplification device, for example, a resonator, an eccentric, or a magnifying lens, to amplify the dispensing signal. The use of multiple signaling elements can also amplify the dispensing signal.

In alternative embodiments, the propulsion element can have multiple openings. These openings can be evenly or unevenly spaced along the longitudinal axis of the propulsion element. The housing, end cap, or mechanical holder can have one or more signal elements. The signal element can be arranged on a spring-loaded or elastic arm of the housing, end cap, or mechanical holder. The signal element can be designed as a radially inwardly projecting projection. The design, arrangement, and function of the openings and the signal element otherwise correspond to the embodiments already mentioned above. This ensures that the patient is notified that the dispensing process is taking place during the entire or at least partial extension stroke of the piston or propulsion element.

The multiple openings of the mechanical holder, the end cap, or the housing according to the aforementioned alternative embodiments, or the multiple openings of the propulsion element according to the aforementioned alternative embodiments, can preferably be arranged at uniform intervals along the longitudinal axis of the autoinjector, with a first and a second row of multiple openings being provided along the longitudinal axis of the autoinjector. The first and second rows of multiple openings arranged along the longitudinal axis are preferably arranged circumferentially offset from each other by 180° on the mechanical holder, the end cap, the housing, or the propulsion element. Furthermore, the openings of the first and second rows can preferably be arranged axially offset from each other along the longitudinal axis. Preferably, two corresponding signal elements, in particular a first and a second signal element, can be provided on the propulsion element, the housing, the end cap, or the mechanical holder, which The first and second signal elements interact with the openings of the first and second rows in such a way that a dispensing signal, in particular an acoustic, haptic, and/or visual signal, is generated. The first and second signal elements interact with the openings of the first and second rows in such a way that they can engage the openings of the first and second rows alternately, and in particular not simultaneously. This ensures that, at any given time, for example, only a single acoustic signal, in particular a rattling or clicking sound, is audible from the interaction of the first signal element with the first row of openings, or a rattling or clicking sound from the interaction of the second signal element with the second row of openings. Furthermore, the alternating arrangement of the openings of the first and second rows increases the number of clicking or rattling sounds, thus providing the patient with a clearer indication that the dispensing process is underway. In alternative embodiments, instead of the openings of the first and second rows, the first and second signal elements can be arranged axially offset from each other along the longitudinal axis. Furthermore, in alternative embodiments, a plurality of rows of openings can be provided, which can interact with corresponding signal elements. The rows of openings and the signal elements can be arranged regularly or irregularly offset from each other in the circumferential direction. In alternative embodiments, instead of rows of openings, rows of ribs, teeth, or webs, or rows of recesses, can be provided. In alternative embodiments, the depths of the openings or...

Recesses or the height of ribs, teeth, or bridges may be designed differently to produce different loud acoustic signals.

In alternative embodiments, the housing, cap, or mechanism holder may have one or more signal elements. The signal element may be arranged on a spring-loaded or elastic arm of the housing, cap, or mechanism holder. The signal element may be designed as a radially inwardly projecting projection. If several signal elements are provided, they may be arranged along the longitudinal axis or, alternatively, circumferentially spaced evenly or unevenly spaced from one another on the housing, cap, or mechanism holder. During the dispensing process, the signal element may slide over the dispensing spring, particularly over the coils of the dispensing spring, to generate an acoustic, haptic, and/or visual signal. This ensures that the patient is notified that the dispensing process is taking place during the entire or at least partial dispensing stroke of the piston or drive element. For this purpose, the thrust member can have an opening, in particular a longitudinal opening, along its longitudinal axis, wherein the signal member(s) can project through the opening, in particular the longitudinal opening of the thrust member, in order to communicate with the discharge spring, in particular with the The coils of the discharge spring interact in such a way as to generate a discharge signal. The discharge spring can therefore be arranged inside the drive element. In alternative embodiments, the discharge spring can be arranged outside the drive element. If the discharge spring is arranged outside the drive element, the drive element can serve as a guide for the discharge spring, so that the discharge spring is guided or supported in a pre-tensioned and/or relaxed state. Thus, a guide located on the housing, the housing-mounted element, in particular the end cap, can be omitted. Furthermore, the autoinjector can include an amplification device, for example, a resonator, eccentric, or magnifying lens, to amplify the discharge signal. The use of multiple signal elements can also amplify the discharge signal.

The invention and further aspects of the invention have been described with reference to several preferred embodiments. Particularly preferred embodiments are described below with reference to figures. The features disclosed therein advantageously further develop the subject matter of the invention, both individually and in any combination thereof. The figures show:

Figure 1 Exploded view of an autoinjector according to a particularly preferred embodiment,

Figures 2a, 2b show the device from Figure 1 in a delivery state, wherein Figures 2a and 2b are sectional views passing through the longitudinal axis of the device, the sectional views being offset by 90° about the longitudinal axis.

Figures 3a, 3b show the device and the views from Figures 2a and 2b, wherein a needle guard sleeve (3) is in its actuated position and an axially fixed engagement or an axially fixed coupling between a drive element (6) and the mechanical holder (5) is releasable.

Figures 4a, 4b show the device and the views from Figures 2a and 2b, wherein a discharge signal is generated during product discharge.

Figures 5a, 5b show the device and the views from Figures 2a and 2b, wherein the device is in the discharged position, with no discharge signal being generated or the discharge signal being silent.

Figures 6a, 6b show the device and the views from Figures 2a and 2b, with the needle guard sleeve in its needle guard position.

Figures 7a and 7b show an alternative device with an alternative signaling device, wherein Figures 7a and 7b are sectional views passing through the longitudinal axis of the device and wherein a discharge signal is generated during product discharge. Figures 8a and 8b show a further alternative device with a further alternative signaling device, wherein Figures 8a and 8b are sectional views passing through the longitudinal axis of the device and wherein a discharge signal is generated during product discharge.

Figures 9a and 9b show another alternative device with an adapter to adjust the distance between a drive element (6”) and a piston, the device shown in Figure 9a before adjustment and the device shown in Figure 9b after adjustment.

Figures 10a and 10b show another alternative device with an adapter to absorb at least part of the kinetic energy of a propulsion element (6'”) at the start of product discharge, wherein the device in Figure 10a is shown before absorption and the device in Figure 10b is shown after absorption.

Figures 11a and 11b show another alternative device with an adapter to absorb at least part of the kinetic energy of a propulsion element (6'”) at the start of product discharge, wherein the device in Figure 11a is shown before absorption and the device in Figure 11b is shown after absorption.

Referring to Figures 1 to 11b, the structural features and functions of preferred embodiments will now be described.

The autoinjector has a sleeve-shaped, elongated housing (2) with a longitudinal axis L, which has a sealing cap (10) at its proximal end that is positively connected to the housing (2) in a rotationally and axially fixed manner. The sealing cap (10) is connected to the housing (2), for example, via a snap-fit connection.

In the delivery state (Figures 2a and 2b) a pull-off cap (4) is arranged at the distal end of the autoinjector, which is pulled off or twisted off and removed before the autoinjector is used.

A product container (11) in the form of a syringe (11) is mounted immovably in the housing (2) along the longitudinal axis L with respect to the housing (2), except for the mounting of the autoinjector. The product container (11) has a sleeve-shaped syringe body that surrounds a piston (11b) which seals against the inner circumference of the syringe body. The syringe body has a needle (11a) at its distal end, which is in particular permanently connected to the syringe body, and whose distal end is formed by the needle tip. A liquid product, in particular a drug, is arranged within the syringe body between the needle (11a) and the piston (11b), wherein the The liquid product is dispensed from the syringe (11) through the hollow needle (11a) by moving the piston (11b) in a discharge direction, i.e., distally or towards the needle (11a). The syringe body has a so-called finger flange at its proximal end, which projects radially outwards beyond the outer circumference of the cylindrical syringe body.

The product container (11) is received in a product container holder (1), which is referred to as a syringe holder (1), such that it is secured at least against movement along the longitudinal axis L in the distal direction relative to the syringe holder (1). The syringe holder is particularly preferably axially and rotationally fixed to the housing (2). The syringe holder (1) has at least one inwardly projecting shoulder (1a) against which a tapered section of the syringe (11), distal to the cylindrical syringe body section that guides the plunger (11b), is supported.

To prevent the syringe (11) from being displaceable in the proximal direction relative to the syringe holder (1), the syringe (11) is pressed at its proximal end into engagement with the shoulder (1a) by a retainer acting on the syringe body. The retainer is designed as a retaining spring (5d), which is provided on a mechanical holder (5). The mechanical holder (5) is axially and rotationally fixed to the housing (2) along the longitudinal axis L. The sleeve-shaped mechanical holder (5) can be snapped or locked to the housing (2). The retaining spring (5d) compensates for length differences in the syringe (11) that may arise due to manufacturing tolerances, thus ensuring a secure fit of the syringe (11) on the shoulder (1a).

The syringe (11) is positioned relative to the housing (2) such that the needle tip extends distally beyond the distal end of the housing (2). In the autoinjector's as-delivered state (Figures 2a and 2b), i.e., when the pull-off cap (4) is attached to the autoinjector, the needle (11a) is covered by a needle shield (12) to protect the needle (11a) from contamination and to maintain the sterility of the needle (11a) and the medication. The needle shield (12) is positioned on a needle-holding section of the syringe body, with the tapered section of the syringe body located between the needle-holding section and the cylindrical section of the syringe body. The shoulder (1a) is positioned between the syringe body, specifically the tapered section, and the proximal end of the needle shield (12). The puller cap (4) is detachably snapped to the housing (2) or a needle guard sleeve (3), and this snap is released when the puller cap (4) is removed from the housing (2) or the needle guard sleeve (3). The puller cap (4) has a snap hook (4a) that can engage the proximal end of the needle guard cap (12). When the puller cap (4) is removed from the auto-injector, the snap hook (4a) engages the proximal end of the needle guard cap (12), which releases the needle guard cap (12) from the syringe (11) and removes it together with the cover cap (4) from the autoinjector.

The autoinjector has a needle guard sleeve (3) that can be displaced relative to the housing (2) and along the longitudinal axis L by one actuation stroke in the proximal direction into an actuated position to trigger product dispensing. In the initial position of the needle guard sleeve (3), the distal end of the needle guard sleeve (3) extends distally beyond the needle tip of the needle (11a), thus initially preventing access to the needle tip. By displacing the needle guard sleeve (3) by the actuation stroke, the needle guard sleeve (3) is moved sufficiently in the proximal direction to expose the needle.

(11a) protrudes from the distal end of the needle sheath (3), in particular with a length corresponding to the injection depth of the needle into the injection site. Preferably, the needle (11a) should protrude beyond the distal end of the needle sheath (3) to such an extent that a subcutaneous injection can be performed.

After injection, the needle guard sleeve (3) can be moved relative to the housing (2) from the actuated position along the longitudinal axis L by one needle guard stroke in the distal direction into a needle guard position (Figures 6a and 6b). In the needle guard position, the distal end of the needle guard sleeve (3) extends distally beyond the needle tip, thus preventing access to the needle tip and reducing the risk of injury. The needle guard sleeve (3) can be locked against being moved back out of the needle guard position, particularly by means of a locking device, as described below.

The autoinjector further comprises a sleeve-shaped propulsion element (6). A discharge spring (8) is arranged within the sleeve-shaped propulsion element (6). The discharge spring (8) is pre-tensioned in the initial state within the propulsion element (6) and is pre-tensioned with sufficient energy to discharge the product contained in the syringe (11), in particular completely, from the syringe (11) by moving the propulsion element (6) by one discharge stroke.

In the delivered state or in the starting position of the autoinjector, there is a gap between the piston

(1 l b) and the distal end of the drive element (6) a distance, so that the drive element (6) only strikes the piston (11b) during the execution of the discharge stroke and carries it along in the discharge direction.

In preferred embodiments, as shown in Figures 9a and 9b, the distance between the drive element (6”) and the piston can be adjusted, in particular reduced, during the assembly of the autoinjector by using an adapter (13). For this purpose, the adapter (13) can have teeth (13a) which engage with mating teeth (6c) arranged on the drive element (6”). The distance between the piston provided in the syringe and the adapter (13) can be adjusted by an axial relative movement between the adapter (13) and the drive element (6”), since the piston is located at different positions within the syringe due to the different filling volumes of the syringes.

As shown in Figures 10a, 10b, 11a, and 11b, the use of an adapter (13'; 13") in an autoinjector can also, or alternatively, prevent the risk of glass breakage during the start of the dispensing process. This risk arises particularly when, at the start of the dispensing process, the propellant (6'"; 6'"") impacts the piston with a sudden force. This energy is at least partially absorbed by the friction between the adapter (13'; 13") and the syringe body when the adapter (13'; 13") impacts the piston located inside the syringe. For this purpose (Figures 10a and 10b), the adapter (13') can have a pinch element (13b) which can interact with a counter-pinch element (6d) provided on the propellant (6'"), so that the impact energy is at least partially absorbed due to the pinch of the pinch element (13b). is absorbed. Alternatively (Figures 11 a and 11 b) the damping effect can be achieved by a threaded connection (13c, 6e) between an adapter (13') and a drive member (6'”'), in particular between a thread (13c) on the adapter (13') and a mating thread (6e) on the drive member (6'”').

The mechanical holder (5) comprises an engagement cam (5a) and a guide cam (5b). In this example, the mechanical holder (5) includes a spring-loaded or elastic arm that encompasses the engagement cam (5a) and the guide cam (5b). The engagement cam (5a) points radially to the longitudinal axis L, while the guide cam (5b) points radially away from the longitudinal axis L. The engagement cam (5a) engages in a recess (6a) provided on the drive element (6), thereby preventing movement of the drive element (6) relative to the mechanical holder (5) in the distal direction or in the discharge direction. This keeps the discharge spring (8) in its tensioned state. The end cap (10) has a guide (10a) that is inserted into the core of the discharge spring (8) through its proximal end. The guide (10a) prevents the discharge spring (9) from buckling laterally during and at the end of the discharge stroke of the drive element (6).

The autoinjector has a locking sleeve (7). In the delivery state or in the initial position of the autoinjector, the engagement cam (5a) is held in engagement or coupling with the recess (6a) of the drive element (6) by an inner circumference of the locking sleeve (7), which bears against the guide cam (5b).

The locking sleeve (7) is connected to the needle guard sleeve (3), in particular to a proximal end of the

needle guard sleeve (3) rotatably connected, or is located on the needle guard sleeve (3), in particular on the proximal end of the needle guard sleeve (3). A discharge spring (9) is supported with its distal end on the locking sleeve (7) and with its proximal end on the closure cap (10).

The locking sleeve (7) and the mechanism holder (5) have a releasable anti-rotation device. The mechanism holder (5) comprises a rib (5f) which can engage and disengage with a first groove (7b) provided on the locking sleeve (7). In the initial position of the needle guard sleeve (3), the rib (5f) of the mechanism holder (5) is engaged with or engaged with the first groove (7b) of the locking sleeve (7). By moving the needle guard sleeve into the actuated position (Figures 3a and 3b), the rib (5f) disengages from the engagement with or engagement with the first groove (7b) of the locking sleeve (7). The anti-rotation device between the locking sleeve (7) and the mechanism holder (5) is released, at least in the actuated position of the needle guard sleeve (3).

The locking sleeve (7) has a guide cam (7e) which can be engaged or disengaged with the guide cam (5b) of the mechanism holder (5). By moving the needle guard sleeve into the actuated position of the needle guard sleeve (3) (Figures 3a and 3b), the guide cam (5b) of the mechanism holder (5) engages or engages with the guide cam (7e) of the locking sleeve (7).

The locking sleeve (7) further comprises a spring-loaded or elastically arranged locking element (7d), which, together with a locking stop (5c) provided on the mechanical holder (5), forms a locking device. The locking device serves to lock the needle guard sleeve (3) in its needle guard position, as shown in Figures 6a and 6b.

To administer the product from the syringe (11), the pull-off cap (4) is removed from the autoinjector along with the needle guard cap (12). The distal end of the needle guard sleeve (3) is placed against the patient's injection site, and the housing (2) is moved towards the injection site. This causes the needle guard sleeve (3) to move from its initial position by the actuation stroke in the proximal direction relative to the housing (2) into the actuated position. This tensions the needle guard spring (9), which in turn moves the locking sleeve (7) along the needle guard sleeve (3) by the actuation stroke. The locking sleeve (7) has a recess (7a) which is moved into the position of the guide cam (5b) by sliding the locking sleeve (7) along the longitudinal axis L by the actuation stroke. This disengages the engagement cam (5a) from the engagement with the drive element (6), in particular from the engagement with the recess (6a) of the drive element (6), with a movement transverse to and away from the longitudinal axis L, while simultaneously the guide cam (5b) engages with the guide cam (7e) of the locking sleeve (7). This releases the drive element (6) for movement by the discharge stroke in the discharge direction (Figures 3a and 3b). Furthermore, the first groove (7b) of the Locking sleeve (7) disengages from the engagement with the rib (5f) of the mechanics holder (5), whereby the rotation lock between the locking sleeve (7) and the mechanics holder (5) is released.

The drive element (6) moves distally due to the relaxation of the spring force of the discharge spring (8) in order to discharge the product from the syringe (11). During product discharge, a discharge signal, in particular an acoustic discharge signal, is generated, as shown in Figures 4a, 4b, 7a, 7b, 8a and 8b.

In preferred embodiments according to Figures 4a and 4b, the propulsion element (6) comprises a signal element (6b). In this example, the propulsion element (6) includes a resilient or elastic arm which encompasses the signal element (6b). The signal element (6b) is a radially outwardly projecting projection which interacts with openings (5e) provided along the longitudinal axis in the mechanical holder (5) such that a discharge signal, in particular an acoustic signal, is generated during the entire or at least partial discharge process. In this example, the openings (5e) in the mechanical holder (5) are spaced uniformly apart from one another. Furthermore, in this example, a first and second row of openings (5e) are provided on the mechanical holder (5), wherein the first and the second row of openings (5e) are arranged circumferentially offset from one another by 180° on the mechanical holder (5). The openings (5e) of the first and second rows are arranged axially offset from each other along the longitudinal axis on the mechanical holder (5). This ensures that the patient is notified that the dispensing process is in progress or underway during the entire or at least partial dispensing stroke of the piston or drive element. In this example, a first and a second signal element (6b) are provided, which can interact with the openings (5e) of the first and second rows. This allows an alternating clicking or rattling sound to be generated during the dispensing process. The end of the product dispensing (Figures 5a and 5b) is indicated by the cessation of the dispensing signal, as there is no longer any axial relative movement between the signal element (6b) and the openings (5e).

In alternative embodiments according to Figures 7a and 7b, the thrust member (6'””) has several openings (6f). In this example, the openings (6f) are evenly spaced from one another. Furthermore, in this example, a first and second row of openings (6f) are provided on the thrust member (6'””), wherein the first and second rows of openings are arranged circumferentially offset from each other by 180°. The openings of the first and second rows are also axially offset from each other along the longitudinal axis of the thrust member (6'””). The mechanical holder (5”) has the signal element (5g), wherein the signal element (5g) in this example is provided on a resilient or elastic arm of the mechanical holder (5”). The signal element (5g) is a radially outwardly projecting projection which has openings (6f) provided along the longitudinal axis. the drive element (6'") interacts in such a way that a discharge signal, in particular an acoustic signal, is generated during the entire or at least partial discharge process. In this example, a first and a second signal element (5g) are provided, which can interact with the openings (6f) of the first and second rows. Thus, an alternating clicking or rattling sound can be generated during the discharge process.

In alternative embodiments according to Figures 8a and 8b, the mechanical holder (5') has a signal element (5g'). In this example, the signal element (5g') is arranged on a spring-loaded or elastic arm of the mechanical holder (5'). The signal element (5g') is designed as a radially inwardly projecting projection which can slide over the discharge spring (8'), in particular over the coils (8a) of the discharge spring (8'), to generate an acoustic signal. Alternatively, the discharge spring can be arranged within the drive element, wherein the drive element has an opening arranged along its longitudinal axis, in particular a longitudinal opening, and wherein the signal element can project through the opening, in particular through the longitudinal opening of the drive element, to interact with the discharge spring, in particular the coils of the discharge spring, in such a way that a discharge signal is generated.

By removing the autoinjector from the injection site, the needle guard spring (9), the locking sleeve (7), and the needle guard sleeve (3) can move from the actuated position to the needle guard position (Figures 6a and 6b) by the needle guard stroke, whereby the locking sleeve (7) rotates relative to the mechanical holder (5). This relative rotation between the guide cam (7e) and the guide cam (5b) causes the locking element (7d) of the locking sleeve (7) to align axially with the locking stop (5c) of the mechanical holder (5). Additionally, a second groove (7c) of the locking sleeve aligns axially with the rib (5f) of the mechanical holder (5) to guide the needle guard sleeve (3) into the needle guard position (Figures 6a and 6b). In the needle guard position (Figures 6a and 6b), the locking mechanism prevents the needle guard sleeve (3) from being pushed back into its actuated position. When attempting to push the needle guard sleeve (3) back from the needle guard position into the actuated position, the locking element (7d) of the locking sleeve (7) abuts the locking stop (5c) of the mechanical holder (5), thereby preventing the movement of the needle guard sleeve 3 into the actuated position.

Reference symbol list

1 product container holder, syringe holder

1 a limb, shoulder

2 cases

3 Needle guard sleeve 4 Pull cap

4a Snap hook

5; 5’; 5” Mechanism holder

5a Engagement cam

5b Guide cam

5c Locking stop

5d retaining spring

5 openings

5f rib

5g; 5g’ Signal element

6; 6’; 6”; 6’”; 6””; 6’”” Drive member

6a Exclusion

6b Signal element

6c Counter toothing

6d Counter-squeeze element

6e Counter thread

6f openings

7 Locking sleeve

7a Recess

7b first groove

7c second groove

7d Locking element

7e Leadership backdrop

8;8’ Discharge spring

8a turns

9 Needle guard spring

10 Cap

10a Guided Tour

11 product containers, syringe

11a Needle

11b Piston

12 Needle guard cap

13; 13’; 13” Adapter

13a Toothing

13b Squeeze element

13c thread L Longitudinal axis

Claims

Claims 1. Autoinjector for dispensing a liquid product, in particular a pharmaceutical product, comprising: a) a housing (2) or a mechanical holder (5; 5'; 5”) axially and rotationally fixed to the housing (2) and a product container (11), in particular a syringe, arranged in the housing (2) or in the mechanical holder (5; 5'; 5”), which has a movable piston (11b), wherein the piston (11b) is movable in a dispensing direction for dispensing the product contained in the product container (11), b) a propulsion element (6; 6';6”;6'”;6'”’; 6’””) which acts on the piston (11b) during product dispensing, and a dispensing spring (8) which acts on the propulsion element (6; 6';6”;6’”;6’”’; 6’””), c) a needle guard sleeve (3) and a needle guard spring (9) which is displaceable from its initial position relative to the housing (2) or relative to the mechanical holder (5; 5'; 5”) and along the longitudinal axis (L) of the autoinjector in a proximal direction by one actuation stroke, thereby tensioning the needle guard spring (9) and triggering the product discharge, d) a locking sleeve (7) which is arranged geometrically or kinematically between the needle guard spring (9) and the needle guard sleeve (3), wherein the locking sleeve (7) is carried along by the needle guard sleeve (3) in the proximal direction when the needle guard sleeve (3) is displaced from its initial position in the proximal direction, wherein e) the needle guard sleeve (3) is displaced after the product discharge when the actuator (6; 6';6”;6’”;6’”’; 6’””) or the piston (11 b) is displaced by the discharge stroke in the distal direction The needle guard sleeve (3) is displaceable by the needle guard spring (9) relative to the housing (2) or relative to the mechanical holder (5; 5'; 5”) into a needle guard position in which the needle guard sleeve (3) is distal to the needle tip of a needle (11a) of the product container (11), characterized in that the locking sleeve (7) and the housing (2) or the mechanical holder (5; 5'; 5”) can engage or couple, the engagement or couple being designed such that the locking sleeve (7) rotates relative to the housing (2) or relative to the mechanical holder (5; 5'; 5”) when the needle guard sleeve (3) is displaced relative to the housing (2) or relative to the mechanical holder (5; 5'; 5”) into the needle guard position, wherein a locking device is provided on the locking sleeve (7) and on the housing (2) or the mechanical holder (5; 5'; 5”), which is located in the In the needle guard position, the needle guard sleeve (3) is locked relative to the housing (2) or relative to the mechanical holder (5; 5'; 5”) against being pushed back in the proximal direction in such a way that the needle tip cannot protrude from the distal end of the needle guard sleeve (3). 2. Autoinjector according to claim 1, characterized in that the locking sleeve (7) has a spring-loaded or elastic locking element (7d) and the housing (2) or the mechanical holder (5; 5'; 5”) has a locking stop (5c) or alternatively, that the housing (2) or the mechanical holder (5; 5'; 5”) has a spring-loaded or elastic locking element and the locking sleeve (7) has a locking stop to lock the needle guard sleeve (3) in the needle guard position. 3. Autoinjector according to claim 1 or 2, characterized in that the housing (2) or the mechanical holder (5; 5'; 5”) has an engagement cam (5a) which detachably engages the drive element (6; 6'; 6”; 6'”; 6'”'; 6'””), whereby the drive element is axially fixedly coupled to the housing (2) or the mechanical holder (5; 5'; 5”), wherein the axially fixed coupling or the axially fixed engagement between the drive element (6; 6'; 6”; 6'”; 6'”'; 6'””) and the housing (2) or the mechanical holder (5; 5'; 5”) is released when the engagement cam (5a) is disengaged from the engagement or from the coupling with the drive element (6; 6'; 6”; 6'”; 6'”'; 6'””). to empty the product from the product container (11). 4. Autoinjector according to one of the preceding claims, characterized in that the housing (2) or the mechanical holder (5; 5'; 5”) has a guide cam (5b) which can engage or couple with a guide cam (7b) on the locking sleeve (7) in order to rotate the locking sleeve (7) relative to the housing (2) or relative to the mechanical holder (5; 5'; 5”) or alternatively, that the housing (2) or the mechanical holder (5; 5'; 5”) has a guide cam which can engage or couple with a guide cam on the locking sleeve (7) in order to rotate the locking sleeve (7) relative to the housing (2) or relative to the mechanical holder (5; 5'; 5”). 5. Autoinjector according to claims 3 and 4, characterized in that the engagement cam (5a) and the guide cam (5b) are aligned such that the cam control, in particular the rotational guide between the locking sleeve (7) and the housing (2) or the mechanical holder (5), is already engaged or coupled when the engagement cam (5a) is not yet completely disengaged from engagement or coupling with the drive element (6; 6'; 6”; 6'”; 6'”'; 6'””). 6. Autoinjector according to one of the preceding claims, characterized in that in the initial position of the needle guard sleeve (3) a releasable rotation lock is provided between the locking sleeve (7) and the housing (2) or the mechanical holder (5; 5'; 5”) to prevent rotation of the locking sleeve (7) relative to the housing (2) or the mechanical holder (5; 5'; 5”). 7. Autoinjector according to claim 6, characterized in that the rotation lock between the locking sleeve (7) and the housing (2) or the mechanical holder (5; 5'; 5”) is released when the needle guard sleeve (2) is in its actuated position, wherein in the actuated position the drive element (6; 6';6”;6'”;6'”';6'””) is movable in the proximal direction for product discharge and the locking sleeve (7) is rotatable relative to the housing (2) and the mechanical holder (5; 5'; 5”) to lock the needle guard sleeve (3) in the needle guard position. 8. Autoinjector according to one of the preceding claims, characterized in that the needle guard sleeve (3) is arranged to rotate relative to the housing (2) or to the mechanical holder (5; 5'; 5”) and to be axially movable. 9. Autoinjector according to one of the preceding claims, characterized in that the propulsion member (6) has a spring-loaded or elastic signal member (6b) which interacts with openings (5e) arranged on the housing (2) or on the mechanical holder (5) along the longitudinal axis (L) in such a way that a discharge signal is generated during the entire or at least partial discharge stroke of the propulsion member (6) or the piston (11b). 10. Autoinjector according to claim 9, characterized in that the openings (5e) are arranged uniformly or non-uniformly along the longitudinal axis (L) of the housing (2) or the mechanical holder (5). 11. Autoinjector according to claim 9 or 10, characterized in that the signal element (6b) is provided at a proximal end or at a proximal region of the thrust element (6). 12. Autoinjector according to one of claims 9 to 11, characterized in that the signal element (6b) is designed as a radially outwardly projecting projection. 13. Autoinjector according to one of claims 9 to 12, characterized in that the autoinjector has an amplification device to amplify the discharge signal. 14. Autoinjector according to one of the preceding claims, characterized in that an adapter (13, 13', 13”) is arranged between the propulsion element (6; 6'; 6”; 6'”; 6'”'; 6'””) and the piston (11 b) of the product container (11) in order to adjust the distance between the propulsion element (6; 6'; 6”; 6'”; 6'”'; 6'””) and the piston (11 b) in the initial state and/or to at least partially absorb the kinetic energy of the propulsion element (; 6'; 6”; 6'”; 6'”'; 6'””) when the product discharge starts. 15. Autoinjector according to claim 14, characterized in that the adapter (13', 13”) is arranged to be axially movable within the drive element (6; 6'; 6”; 6”'; 6'”'; 6’””).