AUTOINJECTOR WITH ONE NEEDLE GUARD

Description

[0001] The invention relates to an auto-injector, often also referred to as an auto-injection device, with which a product contained in a product container can be automatically dispensed after activation. The liquid product is, in particular, a medicament. In particular, the invention relates to a signaling device that emits an acoustic and / or tactile signal at the beginning and / or end of the product dispensing to inform the user of the beginning and / or end of the product dispensing, and / or in particular, the invention relates to an auto-injector with a needle protection sleeve.

[0002] Auto-injectors are known in the art. Devices that signal product dispensing are also known. DE 102008037310 A1 and WO 2010 / 017650 A1 disclose an injection device that has a spring element on the piston rod. At the end of the automatic dispensing, this spring element snaps radially over ribs on the housing, causing the so-called "end click."

[0003] Furthermore, EP2742962 discloses an injection device, in particular an auto-injector, which has a so-called start click, which is supported on the piston rod and, when the auto-injector is triggered, separates from the piston rod and is displaced in the proximal direction by means of a drive spring in order to generate a start click.

[0004] It is an object of the invention to provide an alternative auto-injector, wherein the auto-injector is to be designed to be cost-effective and reliable in operation.

[0005] The problem is solved with the autoinjector according to claim 1. Advantageous further developments emerge from the dependent claims, the description and the figures.

[0006] The auto-injector according to the invention has a housing and a product container arranged in the housing. The product container can in particular be a syringe which has a syringe body at the distal end of which an injection needle is fixedly arranged. The preferably cylindrical syringe body surrounds a piston which is displaceable with respect to the syringe body and is displaced towards the distal end for product dispensing, whereby the liquid product, in particular medication, arranged between the piston and the injection needle is dispensed from the product container through the injection needle. The syringe body can have a flange, which can also be referred to as a finger flange, at its proximal end, i.e. the rear end or end opposite the injection needle.A syringe designed in this way is available as a standard syringe, eliminating the need to develop a specially adapted syringe for the auto-injector. The plunger forms a seal against the inner diameter of the syringe body.

[0007] The housing is preferably elongated and forms the longitudinal axis of the auto-injector. The housing is preferably sleeve-shaped and / or cylindrical, in particular circular-cylindrical. The product container is arranged in the housing. For example, the container can be arranged displaceably in the housing, i.e. displaceable in the distal direction relative to the housing for automatic piercing, so that the needle tip protrudes from an opening at the distal end of the auto-injector 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 the product has been dispensed, in particular the product container can be moved in the proximal direction relative to the housing.

[0008] In preferred embodiments, the product container is accommodated in the housing so as to be non-displaceable along its longitudinal axis, in particular by means of a product container holder or syringe holder which holds the product container axially fixed and is connected, in particular locked, to the housing in an axially fixed manner. The needle tip preferably projects beyond the distal end of the housing in the distal direction. This allows the needle to be inserted into the puncture site by moving the housing towards the patient. A needle protection sleeve is preferably provided which forms the distal end of the auto-injector and has an opening for the injection needle, wherein the needle can pass through the opening. In its initial position with respect to the needle tip, the needle protection sleeve can be arranged such that the needle protection sleeve projects distally beyond the needle tip or such that the needle tip projects distally beyond the distal end of the needle protection sleeve.The needle protection sleeve can be displaced relative to the housing from its initial position in the proximal direction by one actuating stroke into an actuated position, in particular displaced into the housing, so that the needle protrudes or protrudes further from the distal end or through the opening of the needle protection sleeve. Preferably, the needle protection sleeve can be displaced by one needle protection stroke from the actuated position relative to the housing in the distal direction into a needle protection position in which the distal end of the needle protection sleeve projects distally beyond the needle tip in order to prevent a risk of injury from an exposed needle tip after use of the device or after dispensing of the product. The needle protection sleeve can be displaced in the proximal direction, for example against the force of a spring, which can be referred to as a needle protection spring, wherein the spring, which can be referred to as a needle protection spring, for example,the second spring described below or a spring separate therefrom can move the needle protection sleeve from the actuated position in the distal direction, i.e. into the needle protection position. The auto-injector can have a locking member, e.g. spring-mounted, which locks the needle protection sleeve in its needle protection position, in particular with respect to the housing and blocks the needle protection sleeve from being pushed back in the proximal direction or into the housing. The locking member locks the needle protection sleeve at least in such a way that the needle cannot protrude from the distal end of the needle protection sleeve. The needle protection sleeve can, e.g. be moved from the needle protection position in the proximal direction only far enough that the needle tip does not protrude from the distal end of the needle protection sleeve.

[0009] The auto-injector further comprises a propulsion member that acts on the piston, in particular rests against the piston, at least during product dispensing, and a first spring that acts on the propulsion member, such as being supported, in particular, with its distal end on the propulsion member. The propulsion member can, for example, be sleeve-shaped. Furthermore, the propulsion member can comprise one or more ribs, which are arranged, for example, in the region of the distal end of the propulsion member. The distal end of the first spring can be supported on the rib. The rib can extend in the proximal direction. The rib can be provided inside the propulsion member. The rib of the propulsion member can, for example, be provided on an inner side of the propulsion member. The first spring is preferably arranged inside the sleeve-shaped propulsion member. The rib of the propulsion member can serve to adjust the spring tension of the first spring. For example,a longer rib can produce a higher spring preload. The rib can be designed such that the spring tension of the first spring is or is preloaded such that the liquid product, in particular the entire medication in the product container, can be poured out. The length of the rib or the rib can determine a preload of the first spring such that it can pour the product out of the product container by moving the propulsion member by a dispensing stroke (HA). The rib can also serve to reinforce the propulsion member, in particular that part of the propulsion member on which the first spring is supported. This can prevent the propulsion member from being damaged, in particular broken, by the spring force of the first spring. In an alternative embodiment, different springs with different spring tensions can be or are used inside the propulsion member as required.By selecting an appropriate spring, the spring tension can be selected such that the liquid product, in particular the entire medication in the product container, can be poured out. There can be at least two auto-injectors, wherein the corresponding length of the ribs differs in order to have a desired spring force. Alternatively, there can be at least two auto-injectors, each with different springs with correspondingly different spring tensions in order to have a desired spring force. In particular, a first and a second auto-injector can be provided, wherein the length of the ribs of the first auto-injector is different from the length of the ribs of the second auto-injector, and the auto-injectors are otherwise identical. The first spring is preferably a helical spring acting as a compression spring, which is preferably made of metal.The first spring is pre-tensioned to such an extent, particularly in the as-delivered state of the auto-injector, that it, or rather the energy stored in it, is sufficient to essentially completely dispense the product from the product container by moving the propulsion element by one dispensing stroke. Displacing the propulsion element by the dispensing stroke also displaces the piston. If there is a gap between the piston and the propulsion element in the as-delivered state, the dispensing stroke of the piston is shorter than the dispensing stroke of the propulsion element. This is preferred because the piston remains unloaded until use, thus preventing unwanted premature product dispensing. In principle, however, it is also possible for the propulsion element to rest against the piston in the as-delivered state and not only during product dispensing.If the propulsion element is already in contact with the piston in the delivery state, the piston's discharge stroke corresponds to the discharge stroke of the propulsion element. The proximal end of the first spring, which can also be referred to as a discharge spring due to its function, can be supported on the housing or a housing-fixed element, in particular an element that is only temporarily axially fixed to the housing.

[0010] According to the invention, the auto-injector comprises a signal element, a signal stop, and a second spring. The second spring can exert a spring force on the signal element acting counter to the dispensing direction or in the proximal direction. In particular, the second spring can be supported, for example, with its proximal end on the signal element.

[0011] The second spring can, for example, be a helical spring acting as a compression spring, the proximal end of which is supported on the signaling element. The second spring is preferably made of metal. The distal end of the second spring can, for example, be supported on the housing or an element fixed to the housing. The distal end of the second spring is particularly preferably supported on the needle protection sleeve or an element which is displaced with the needle protection sleeve, in particular when the needle protection sleeve is displaced relative to the housing. For example, the element can be a switching module or a switching sleeve, as described further below. The element can, in particular, be arranged kinematically and / or geometrically between the needle protection sleeve and the distal end of the second spring. The advantage here is that the needle protection sleeve can be displaced from its actuated position into the needle protection position by means of the second spring.The spring can therefore preferably fulfil a dual function, as it also exerts the above-mentioned force on the signal element.

[0012] In particular, in the delivery state or during a first partial stroke of the dispensing stroke of the propulsion member, the signaling member can be axially fixedly coupled to the propulsion member, such that the signaling member can be displaced with the propulsion member along the longitudinal axis and in particular relative to the housing, in particular in the distal direction. The axially fixed coupling with the propulsion member has the effect that the signaling member is entrained during the displacement of the propulsion member in the dispensing direction, in particular during the execution of the first partial stroke of the dispensing stroke, and the second spring is tensioned. During a second partial stroke of the dispensing stroke, it is preferred that the axially fixed coupling between the signaling member and the propulsion member is released. The axially fixed coupling between the signaling member and the propulsion member is thus releasable.When the axially fixed coupling between the signaling element and the propulsion element is released - and in particular when there are no further couplings between the signaling element and another element, as described below - the signaling element can be accelerated by means of the second, preloaded spring against the dispensing direction and relative to the propulsion element and / or the housing. Due to the propulsion element driving the signaling element along the first partial stroke, a distance is formed between the signal stop and the signaling element, for example extending along the longitudinal axis and corresponding in particular to the first partial stroke. The second spring can accelerate the signaling element over this distance, whereby the signaling element hits the signal stop at a speed such that an impulse is emitted to the signaling element, which generates an acoustic (audible) and / or tactile (tangible) signal.

[0013] The signal stop can be formed by the housing or by an element that is at least axially fixed and preferably also rotationally fixed to the housing. For example, this element can be a closure cap at the proximal end of the housing and / or form the proximal end of the auto-injector. The closure cap can be connected to the housing particularly preferably in a form-fitting manner, or alternatively in a force-fitting or material-fitting manner. Preferably, the element is latched to the housing. A separate cap has the advantage of facilitating assembly of the device, with at least some of the components being introduced into the housing via the proximal end, which is then closed with the cap. The cap can form a resonating body if the signal stop is arranged on the cap, with the auditory impression of the acoustic signal being able to be modified within certain limits by designing the material thickness and shape of the cap.

[0014] In preferred embodiments, the signaling member has a first engagement member, in particular a resilient engagement member or / and arranged on a resilient arm, which engages releasably in the propulsion member, in particular in a recess of the propulsion member. As a result, the propulsion member is axially fixedly coupled to the signaling member, wherein the axially fixed coupling between the propulsion member and the signaling member is released when the signaling member, in particular the first engagement member, is disengaged or pushed out of engagement with the propulsion member, in particular the recess of the propulsion member. In particular, the first engagement member is disengaged from engagement with the propulsion member at the end of the first partial stroke of the propulsion member.

[0015] Preferably, the signal stop is arranged along the longitudinal axis of the auto-injector such that it is aligned with the signal element. This ensures that the signal element strikes the signal stop with a movement along the longitudinal axis of the auto-injector.

[0016] In embodiments with a needle protection sleeve, it is preferred that the needle protection sleeve acts on the second spring, wherein the needle protection sleeve is displaceable from its initial position relative to the housing and along the longitudinal axis of the auto-injector in the proximal direction, i.e. opposite to the dispensing direction, in particular by the actuating stroke, to trigger the product dispensing. This tensions the second spring and preferably also triggers the product dispensing, in particular the movement of the advancing member in the dispensing direction. The needle protection sleeve is preferably moved from its initial position by the actuating stroke into its actuated position by pressing its distal end against the puncture site of the patient, wherein the housing is displaced relative to the needle protection sleeve in the direction of the puncture site, such that the needle protection sleeve executes the actuating stroke relative to the housing.In this case, the needle protruding from the distal end of the needle protection sleeve is also inserted into the puncture site. After the product has been dispensed, in particular after a short waiting period, such as 3 to 10 seconds, after the signal has been generated by the signal element, the auto-injector is removed from the puncture site, whereby the needle protection sleeve is displaced relative to the housing from its actuated position by the needle protection stroke into the needle protection position, in particular by means of the spring energy stored in the second spring. By removing the auto-injector from the puncture site, the needle is also withdrawn from the puncture site.

[0017] In certain embodiments, a switching module can be kinematically arranged between the second spring and the needle protection sleeve, wherein the switching module is carried along by the needle protection sleeve in the proximal direction when the needle protection sleeve is displaced from its initial position into the proximal direction or into the actuated position, and displaces the needle protection sleeve in the distal direction when the spring acting on the switching module displaces the switching module in the distal direction. The switching module or a part thereof, such as a switching sleeve, can be one-piece with the needle protection sleeve or, for example, be positively connected, such as, for example, snapped, or rest loosely against the needle protection sleeve. The switching module can be a single part or comprise several parts, wherein a multi-part switching module can have at least the switching sleeve and a locking sleeve. The locking sleeve can, for example, bebe movable along the longitudinal axis.

[0018] For example, the second spring can be supported on the switching sleeve and the switching sleeve can be supported on the needle protection sleeve. In alternative embodiments, the switching sleeve and needle protection sleeve can be connected in an axially fixed and preferably rotationally fixed manner, wherein the second spring can be supported on the switching sleeve. In further alternative embodiments, the switching sleeve and needle protection sleeve can be formed as one piece, wherein the second spring can be supported on the switching sleeve. Between the blocking sleeve and the switching sleeve, a locking member can be provided, for example, which acts unidirectionally and is preferably the above-mentioned locking member which locks the needle protection sleeve in its needle protection position. This locking member is formed, for example, by the blocking sleeve and engages in the switching sleeve, in particular in a recess.The locking member is preferably designed such that the switching sleeve, during its movement relative to the housing in the proximal direction, entrains the locking sleeve via the locking member, in particular during the movement of the needle protection sleeve from its initial position into the actuated position, and during its movement relative to the housing in the distal direction, is displaced relative to the locking sleeve into a locking position, in particular during the displacement of the needle protection sleeve from its actuated position into the needle protection position, wherein in the locking position the or another locking member, such as the one mentioned above, blocks movement of the switching sleeve relative to the locking sleeve in the proximal direction. This advantageously prevents the needle protection sleeve from being pushed back into the housing from its needle protection position for a renewed release of the needle tip.

[0019] For example, the switching sleeve can have a first recess into which the locking member of the blocking sleeve releasably engages when the needle protection sleeve is moved from its initial position into its actuated position. For example, the switching sleeve can have a second recess into which the locking member or optionally the other locking member engages when the needle protection sleeve is in its needle protection position. The first and second recesses can preferably be arranged along the longitudinal axis at a distance from one another that approximately corresponds to the needle protection stroke. Of course, a reversal of the arrangement of the recesses and the locking member or locking members is also possible, ie that the at least one locking member can be formed on the switching sleeve and the at least one recess, ie the first recess and optionally the second recess, can be formed on the blocking sleeve.

[0020] In alternative embodiments, the switching sleeve can have a first recess into which the locking member or locking members of the locking sleeve releasably engage when the needle shield is moved from its initial position to its actuated position. The locking member of the locking sleeve can abut the proximal end of the switching sleeve when the needle shield is in its needle protection position. Of course, a reversal of the arrangement of the recess and the locking member is also possible.

[0021] The locking member and, if applicable, the other locking member can be arranged resiliently, in particular each on a resilient arm. Preferably, the switching sleeve can surround and / or guide the locking sleeve.

[0022] In preferred embodiments, the signaling member can have a second engagement member which can be moved into engagement, in particular an axially fixed engagement, with the needle protection sleeve or the switching module, in particular the locking sleeve, by the disengagement movement of the first engagement member, with which the first engagement member disengages from the advancing member. The first engagement member and the second engagement member of the signaling member are preferably coordinated with one another such that the second engagement member already engages, preferably axially fixed, in the needle protection sleeve or the switching module when the first engagement member has not yet been completely disengaged from the engagement with the advancing member. This advantageously and reliably prevents the first engagement member from already being disengaged from the engagement with the advancing member when the second engagement member is not yet in engagement with the needle protection sleeve or the switching module, in particular the locking sleeve.The needle protection sleeve or the switching module, in particular the locking sleeve, can have, for example, a further recess into which the second engagement element of the signaling element engages, for example for the axially fixed coupling between the signaling element and the switching module, in particular the locking sleeve, or the needle protection sleeve. The advancing element can have a recess into which the first engagement element engages for the axially fixed coupling between the advancing element and the signaling element. Preferably, the first engagement element and the second engagement element are formed on a common elastic arm, wherein the first engagement element points, for example radially, towards the longitudinal axis and the second engagement element points, for example radially, away from the longitudinal axis. The first and second engagement elements can be arranged, preferably radially, between the advancing element and the needle protection sleeve or the switching module, in particular the locking sleeve.

[0023] In particular, during the dispensing stroke of the propulsion member, particularly at the end of the first partial stroke, the first engagement member of the signaling member is released from engagement with the propulsion member and, preferably simultaneously, the second engagement member of the signaling member is brought into engagement with the switching module or the needle protection sleeve, particularly with a movement transverse to the longitudinal axis. In particular, the propulsion member, through its movement in the dispensing direction, can press the first engagement member out of the recess of the propulsion member and the second engagement member into the recess of the needle protection sleeve or the switching module, particularly the locking sleeve.

[0024] In particularly preferred embodiments, the needle protection sleeve or the switching module, in particular the locking sleeve, can hold the first engagement member of the signaling member in engagement with the recess of the advancing member, wherein the recess for the second engagement member of the signaling member is displaced towards the second engagement member by displacing the needle protection sleeve from its initial position into its actuated position relative to the longitudinal axis, wherein the recess, in the actuated position of the needle protection sleeve, in particular at the moment at which the dispensing stroke is released, is arranged at a distance from the second engagement member along the longitudinal axis that approximately corresponds to the first partial stroke of the signaling member. The advancing member released for the dispensing stroke by actuating the needle protection sleeve can then be moved by the first partial stroke in the dispensing direction.Preferably, the first engagement member is held in engagement with the propulsion member by the inner circumference of the needle protection sleeve or the switching module, in particular the locking sleeve, against which the second engagement member rests. At the end of the first partial stroke, the second engagement member is located at the same position as the recess relative to the longitudinal axis, allowing the second engagement member to engage its recess and the first engagement member to disengage from its recess.

[0025] The dispensing stroke of the propulsion member can in particular comprise two phases, namely the first partial stroke and the second partial stroke. During the first partial stroke, the first engagement member of the signaling member is in axially fixed engagement with the propulsion member and the second engagement member of the signaling member is out of axially fixed engagement with the needle protection sleeve or the switching module, in particular the locking sleeve. During the second partial stroke of the dispensing stroke, the second engagement member is in axially fixed engagement with the needle protection sleeve or the switching module, in particular the locking sleeve, wherein the first engagement member is out of engagement with the propulsion member, thereby advantageously causing the propulsion member to be movable in the distal direction relative to the signaling member by means of the first spring and / or the signaling member for signal triggering to not yet be released.

[0026] In alternative embodiments, the dispensing stroke can comprise three phases, in particular a further partial stroke. During the first partial stroke, the propulsion member moves axially relative to the signaling member. During the first partial stroke, the signaling member is not loaded. During the second partial stroke, the first engagement member of the signaling member is in axially fixed engagement with the propulsion member and the second engagement member of the signaling member is out of axially fixed engagement with the needle protection sleeve or the switching module, in particular the locking sleeve. During the second partial stroke, the signaling member is loaded.During the third partial stroke of the dispensing stroke, the second engagement member is in axially fixed engagement with the needle protection sleeve or the switching module, in particular the locking sleeve, wherein the first engagement member is out of engagement with the propulsion member, which advantageously causes the propulsion member to be movable in the distal direction relative to the signaling member by means of the first spring and / or the signaling member for signal triggering is not yet released.

[0027] It is generally preferred that the propulsion member is movable relative to the signaling member, in particular by the second partial stroke, in the distal direction by means of the first spring when the first engagement member of the signaling member is out of engagement with the propulsion member and the second engagement member of the signaling member is in engagement with the needle protection sleeve or the switching module.

[0028] In preferred embodiments, the second engagement member of the signaling member and the recess for the second engagement member can be arranged in the delivery state of the auto-injector along the longitudinal axis at a distance from one another which is approximately the sum of the actuating stroke of the needle protection sleeve and the first partial stroke of the propulsion member, which corresponds approximately to the stroke of the signaling member away from the signal stop.

[0029] Preferably, the advance member can prevent the second engagement member of the signaling member from disengaging from the axially fixed engagement with the needle protection sleeve or the switching module when the advance member moves in the distal direction relative to the signaling member, in particular during the second partial stroke of the advance member. The advance member allows the second engagement member to disengage from the needle protection sleeve or the switching module at the end of the dispensing stroke or the second partial stroke. When the second engagement member has disengaged from the needle protection sleeve or the switching module at the end of the second partial stroke, the signaling member is accelerated by the second spring against the dispensing direction and strikes the signal stop. Preferably, the second engagement member is held in engagement with the needle protection sleeve or the switching module by the outer circumference of the advance member, against which the first engagement member bears.

[0030] In preferred embodiments, the auto-injector can have a holding element on which, for example, one end of the first spring, in particular the proximal end of the first spring, is supported. Alternatively, the spring can be supported with its proximal end on the housing or an element fixed to the housing. The holding element itself can be fixed to the housing or arranged so as to be displaceable with respect to the housing. The holding element can have a first engagement element which engages in the propulsion member before the product dispensing is triggered, thereby preventing the propulsion member from moving in the dispensing direction relative to the holding element and / or the housing. The engagement of the first engagement element in the propulsion member is releasable for the product dispensing. When the engagement is released, the propulsion member is released for movement in the dispensing direction.The first spring can displace the propulsion member relative to the holding element and / or the housing by the discharge stroke in the discharge direction.

[0031] The drive member can have a recess for the first engagement element of the holding element, wherein this coupling between the drive member and the holding element is released when the holding element, in particular the first engagement element, is disengaged from the engagement with the drive member, in particular the recess of the drive member. In particular, the first engagement element can be disengaged from the engagement with the drive member by displacing the needle protection sleeve from the initial position into the actuated position by the actuating stroke. For example, the first engagement element can be held in axially fixed engagement with the drive member by the needle protection sleeve or the switching module, in particular the locking sleeve, when the needle protection sleeve is not in its actuated position or in its initial position. For example,an inner circumference of the needle protection sleeve or the switching module, in particular the locking sleeve, can hold the first engagement element in engagement with the drive member, wherein, for example, a second engagement element, which is described further below, can bear against the inner circumference.

[0032] By moving the needle protection sleeve into its actuated position, the needle protection sleeve or the switching module, in particular the locking sleeve, can allow the first engagement element of the holding element to disengage from the propulsion member, in particular with a movement transverse to the longitudinal axis of the auto-injector. For example, a recess, in particular for the second engagement element of the holding element, which is formed on the needle protection sleeve or the switching module, in particular the locking sleeve, can be arranged in the same position with respect to the longitudinal axis as the first and / or second engagement element, so that the first engagement element can disengage from the propulsion member. For example, the propulsion member can press the first engagement element out of engagement with the propulsion member when the needle protection sleeve is in its actuated position.

[0033] The first engagement element of the holding element can, for example, point radially to the longitudinal axis and / or be arranged on a resilient arm of the holding element.

[0034] The holding element can - as mentioned - have a second engagement element which can be moved into axially fixed engagement with the needle protection sleeve or the switching module, in particular the locking sleeve, by the disengagement movement of the first engagement element from the drive member. The second engagement element can be arranged, for example, on the arm on which the first engagement element is arranged and / or can point radially away from the longitudinal axis, for example. The first engagement element and the second engagement element can be coordinated with one another in such a way that the second engagement element already engages axially fixedly in its recess, which is formed by the needle protection sleeve or the switching module, in particular the locking sleeve, when the first engagement element has not yet been completely released from engagement with the drive member.This advantageously ensures that the axially fixed connection between the holding element and the needle protection sleeve or the switching module is established first, before the axially fixed connection between the holding element and the drive member is released, thus preventing the needle protection sleeve from being pushed back again or further.

[0035] In particular, when the second engagement element of the holding element is in its recess, the propulsion member can move in the distal direction relative to the holding element, in particular due to the energy stored in the preloaded spring. The propulsion member can prevent the second engagement element from disengaging from the axially fixed engagement with the needle protection sleeve or the switching module, in particular the locking sleeve, when the propulsion member moves in the distal direction relative to the signaling member. This preferably also applies at the end of the dispensing stroke, in particular when the second engagement element of the signaling member is released from its recess in order to be accelerated by the second spring against the dispensing direction.

[0036] Particularly in embodiments in which the recess for the second engagement element of the holding element is formed by the needle protection sleeve or the switching sleeve, it is preferred that the second engagement element disengages from its recess at the end of the dispensing stroke in order to be able to move the needle protection sleeve from the actuated position into the needle protection position after the product has been administered. For this purpose, the drive member can have a recess into which the first engagement element can engage, with the second engagement element simultaneously disengaging from its recess, in particular to enable the movement of the needle protection sleeve in the distal direction.

[0037] In embodiments with a switching module having a switching sleeve and a locking sleeve, it is preferred that the second engagement element remains even at the end of the dispensing stroke such that the second engagement element prevents the locking sleeve from being moved in the distal direction relative to the housing and / or the second engagement element, wherein the switching sleeve and / or the needle protection sleeve are displaceable in the distal direction relative to the locking sleeve, in particular due to the energy stored in the second spring, whereby the needle protection sleeve is moved in particular into its needle protection position. As already described and noted only for the sake of completeness, the locking member between the locking sleeve and the switching sleeve can engage, which prevents the switching sleeve from being displaced in the proximal direction relative to the locking sleeve.Preferably, a movement of the locking sleeve in the proximal direction is prevented by the locking sleeve abutting either the housing or an element fixed to the housing, such as a mechanism holder, or the signal element.

[0038] A further aspect of the invention relates to the design of a product container holder, in particular a tip holder for an auto-injector, in particular for an auto-injector in which the product container is immovable with respect to the housing or for an auto-injector of the type described above.

[0039] The invention is based on a syringe module which is particularly intended for use in an auto-injector. In particular, an auto-injector can be provided which has such a syringe module. The syringe module comprises a syringe and a syringe holder. The syringe has a syringe body, a plunger and a needle, wherein the needle is, for example, permanently attached to a needle-holding section of the syringe and the plunger is displaceably arranged in a cylindrical section of the syringe body, wherein the syringe body has a tapered section or region which is arranged between the needle-holding section and the cylindrical section. The syringe further has a needle protection cap which can, for example, be a so-called soft needle shield or, preferably, a rigid needle shield.A soft needle shield is preferably made of a rubber-elastic plastic, whereas a rigid needle shield is made of a hard plastic sleeve in which a rubber-elastic plastic sleeve is arranged. The rubber-elastic plastic sleeve and the hard plastic sleeve together form the rigid needle shield. The needle protection cap, which covers the needle and is attached to the needle holding section, which in particular extends conically towards the needle tip, keeps the needle preferably protected from dirt and sterile. A gap is formed between the tapered section and the needle protection cap, in particular the hard plastic sleeve.

[0040] The syringe holder has at least one engagement member, in particular a shoulder, against which the tapered portion of the syringe rests in the distal direction and which engages in the gap between the needle protection cap and the tapered portion. Advantageously, the engagement of the tapered portion against the at least one shoulder prevents the syringe from moving in the distal direction relative to the syringe holder.

[0041] It is preferred that there is or exists a gap between the shoulder and the needle protection cap so that the needle protection cap remains unloaded by the shoulder. This advantageously prevents the sterility of the needle from being compromised by inadvertent displacement of the needle protection cap by the shoulder.

[0042] In preferred embodiments, the syringe body may have a finger flange at its proximal end, wherein a gap is formed between the finger flange and the syringe body when the tapered portion abuts the shoulder, thereby leaving the finger flange substantially unstressed. This advantageously prevents the finger flange from being overloaded and causing the syringe body to break.

[0043] It is further preferred that the syringe holder has at least one holding member, in particular an outwardly directed projection, with which the syringe holder can be or is connected in an axially fixed manner to a housing of the auto-injector, in particular snapped or snappable.

[0044] In particular, the syringe holder can have at least one cam that is resiliently mounted, in particular on an arm, and is arranged, for example, distally of the holding member. The at least one cam can inhibit or prevent a needle guard from moving from its initial position to its actuated position such that, upon exceeding a limit force exerted on the needle guard along the longitudinal axis L of the auto-injector, the at least one cam is forced out of engagement with the needle guard, whereby the needle guard can be abruptly displaced into its actuated position relative to the housing.

[0045] The housing of the auto-injector can, for example, have a holding section which rests against the syringe holder, in particular against an outer surface or an outer circumference of the syringe holder, and prevents the at least one engagement member of the syringe holder from moving transversely to the longitudinal axis away from the longitudinal axis. In particular, the holding section can be cylindrical and surround the at least one engagement member, preferably two or three or four engagement members, such that the at least one engagement member is arranged within the holding section. For the assembly or insertion of the syringe into the syringe holder, the syringe holder is out of engagement with the holding section of the housing. When the syringe is fully inserted into the syringe holder, in particular the at least one engagement member engages in the gap between the tapered section and the needle protection cap, the syringe module orthe syringe holder is brought into engagement with the holding section, so that the at least one engagement member is prevented from moving out of engagement with the tapered section transversely to the longitudinal axis, in particular away from the longitudinal axis or outwards.

[0046] In a first variant, the at least one engagement member can be resilient, in particular formed on an arm on the syringe holder, wherein the syringe is inserted via the proximal end with the needle first into the syringe holder, which is preferably sleeve-shaped, wherein the needle protection cap deflects the at least one engagement member transversely to the longitudinal axis outwards, i.e. away from the longitudinal axis, wherein, when the needle protection cap has been moved completely past the at least one engagement member, the at least one engagement member snaps into the gap between the tapered region and the needle protection cap. The syringe holder with the syringe is then moved into engagement with the holding section of the housing of the auto-injector, whereby the at least one engagement member is held in engagement with the gap between the needle protection cap and the tapered section and can no longer spring out of this engagement.

[0047] The housing comprises a holding section. The holding section of the housing can be sleeve-shaped and arranged inside the housing. A stop for limiting the axial movement of the needle protection sleeve in the proximal direction can be provided between the sleeve-shaped holding section of the housing and the sleeve-shaped housing. The holding section of the housing preferably projects beyond the distal end of the housing in the distal direction. Furthermore, the holding section can have one or more grooves which, in conjunction with a rail or rails provided on the needle protection sleeve, form an anti-twist device between the housing and the needle protection sleeve. The rail of the needle protection sleeve is preferably provided on an inner surface of the needle protection sleeve. The groove of the holding section is preferably arranged on an outer surface of the holding section.The needle guard can preferably be moved axially in a rotationally fixed manner between the holding portion of the housing and the housing. In alternative embodiments, the one or more grooves can be provided on the needle guard and the one or more rails can be provided on the holding portion of the housing to form a barrier between the housing and the needle guard. The groove of the needle guard is preferably provided on an inner surface of the needle guard. The rail of the holding portion is preferably arranged on an outer surface of the holding portion.

[0048] The invention and the further aspect 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 individually and in any combination of features. They show: Figure 1a-1b exploded views of an autoinjector according to a particularly preferred embodiment, Figures 2a-2c the autoinjector from Figure 1 in a delivery state, whereby the Figures 2a to 2c are sectional views through the longitudinal axis of the device, the sectional views being angularly offset about the longitudinal axis, Figures 3a-3c show the device and the views from the Figures 2a-2c , with a needle protection sleeve in its actuated position, Figures 4a-4c the device and the views from the Figures 2a-2c , wherein the propulsion member is shown at the end of a first partial stroke of its discharge stroke, Figures 5a-5c the device and the views from the Figures 2a-2c , showing a propulsion member at the end of its discharge stroke, Figures 6a-6c the device and the views from the Figures 2a-2c , whereby a signal signaling the end of the product discharge is generated, Figures 7a-7c the device and the views from the Figures 2a-2c , wherein the needle protection sleeve is in its needle protection position, Figure 8perspective views and longitudinal sections of the propulsion member Figure 9an alternative embodiment of the propulsion member according to Figure 8 , whereby the rib 7c' has a different length.

[0049] Referring to the Figures 1-8 The structural features and function of the preferred autoinjector are now described.

[0050] The auto-injector comprises a sleeve-shaped, elongated housing 2 with a longitudinal axis L, which has a closure cap 12 at its proximal end, which is positively connected to the housing 2 in a rotationally and axially fixed manner and forms the proximal end of the auto-injector. The closure cap 12 is snapped onto the housing 2. For this purpose, the closure cap 12 has a locking member 12a, which is engaged in a recess 2a on the housing 2, preferably in such a way that the closure cap 12 cannot be detached from the housing 2 or cannot be easily detached.

[0051] At the distal end of the auto-injector in its delivery state ( Figures 2a-2c ) a pull-off cap 4 is arranged, which is pulled off or twisted off and removed before using the auto-injector.

[0052] A product container 13 in the shape of a syringe is accommodated in the housing 2 so as to be immovable along the longitudinal axis L with respect to the housing 2 - apart from the assembly of the auto-injector. The product container 13 has a sleeve-shaped syringe body surrounding a piston 13b that bears sealingly against the inner circumference of the syringe body. The syringe body has, at its distal end, an injection needle 13a that 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 medication, is arranged within the syringe body between the injection needle 13a and the piston 13b, wherein the liquid product is dispensed from the product container 13 through the hollow injection needle 13a by displacing the piston 13b in a dispensing direction, i.e., in the distal direction or towards the injection needle 13a.The syringe body has a so-called finger flange at its proximal end, which projects radially outwards over the outer circumference of the cylindrical syringe body.

[0053] The product container 13 is received in a product container holder, which is referred to as 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 1 is, as best seen from Figure 2a As can be seen, it is positively connected, in particular latched, to the housing 2. For this purpose, the housing 2 has recesses into which latching elements engage, which are formed here at the proximal end of the syringe holder 1. The syringe holder 1 has at least one inwardly projecting shoulder 1b, against which a tapered section of the product container 13, which is distal to the cylindrical syringe body section that guides the piston 13b, is supported.

[0054] To prevent the product container 13 from being displaced in the proximal direction relative to the syringe holder 1, the product container 13 is pressed at its proximal end into engagement with the shoulder 1b by a holder acting on the syringe body. The holder is formed by a retaining spring section 5c of a mechanical holder 5. The mechanical holder 5 is arranged in particular immovably and / or rotationally fixed with respect to the housing 2 along the longitudinal axis L. The sleeve-shaped mechanical holder 5 can be snapped onto the housing 2. The retaining spring section 5c can compensate for differences in the length of the product container 13 that may arise due to manufacturing tolerances, whereby the firm fit of the product container 13 on the shoulder 1b is ensured.

[0055] The product container 13 is arranged with respect to the housing 2 such that the needle tip projects distally beyond the distal end of the housing 2. In the initial or delivered state of the auto-injector, i.e., when the pull-off cap 4 is arranged on the auto-injector, the needle 13a is covered by a needle protection cap 14, which in the example shown is designed as a so-called rigid needle shield known to those skilled in the art, or alternatively as a soft needle shield, in order to protect the needle 13a from contamination and to keep the needle 13a and the medication sterile. The rigid needle shield 14 is arranged on a needle holding section of the syringe body, wherein the tapered section of the syringe body is located between the needle holding section and the cylindrical section of the syringe body.The shoulder 1b is arranged between the syringe body and the proximal end of the rigid needle shield 14, in particular such that a gap - albeit a small one - is created between the rigid needle shield 14 and the shoulder 1b in order to prevent the shoulder 1b from exerting a force on the rigid needle shield 14, which could, for example, endanger the sterility of the needle 13a or the liquid product. The pull-off cap 4 is releasably snapped to the housing 2 or a needle protection sleeve 3, wherein this snap connection is released when the pull-off cap 4 is removed from the housing 2 or the needle protection sleeve 3. In the example shown, the snap connection is formed by a snap geometry 3b of the needle protection sleeve 3 and a snap hook 4a of the pull-off cap 4 (. Figure 2b). These snap hooks 4a further secure the pull-off cap 4 against proximal movement relative to the housing 2 by finding support fixed to the housing on the housing 2 or on a distal end face on the syringe holder 1. The pull-off cap 4 further has, in particular on a snap hook 4a, at least one snapper 4b which engages in a gap between the syringe body, in particular its tapered region, and the proximal end of the rigid needle shield 14. When the pull-off cap 4 is removed from the auto-injector, the snapper 4b hooks into the proximal end of the rigid needle shield 14, whereby the rigid needle shield 14 is detached from the product container 13 and removed from the auto-injector together with the cover cap 4. Alternatively, the snapper 4b can hook into a lateral surface of the rigid needle shield 14 or into a lateral surface of the soft needle shield.

[0056] The auto-injector has a needle protection sleeve 3, which is displaceable relative to the housing 2 and along the longitudinal axis L by an actuation stroke HB in the proximal direction into an actuated position in order to trigger a product dispensing. In the initial position of the needle protection sleeve 3, as shown in the Figures 2a-2cis shown, with the pull-off cap 4 removed, the distal end of the needle protection sleeve 3 projects distally beyond the needle tip of the needle 13a, so that access to the needle tip is initially prevented. By moving the needle protection sleeve 3 by the actuating stroke HB, the needle protection sleeve 3 is moved far enough in the proximal direction that the needle 13a protrudes from the distal end of the needle protection sleeve 3, in particular protrudes to a length which corresponds to the injection depth of the needle into the puncture site. Preferably, the needle 13a should protrude far enough beyond the distal end of the needle protection sleeve 3 to allow a subcutaneous injection. In particular, the housing 2 can form a stop 2c against which the needle protection sleeve 3 rests in the actuated position.

[0057] After the injection has been completed, the needle protection sleeve 3 can be moved relative to the housing 2 from the actuated position along the longitudinal axis L by a needle protection stroke HN in the distal direction into a needle protection position ( Figures 7a-7c ). In the needle protection position, the distal end of the needle protection sleeve 3 protrudes distally beyond the needle tip, preventing access to the needle tip and reducing the risk of injury. The needle protection sleeve 3 can be blocked from being pushed back out of the needle protection position, as described below.

[0058] The syringe holder 1 has a projection 1a which points radially outwards, wherein the projection 1a engages in a slot-shaped recess of the needle protection sleeve 3 which is arranged between the housing 2 and the syringe holder 1. In the initial position of the needle protection sleeve 3 ( Figures 2a-2c ) and / or in the needle protection position of the needle protection sleeve 3 ( Figures 7a-7c), the needle protection sleeve 3, in particular the proximal end of the slot-shaped recess, rests against the projection 1a, thereby preventing movement of the needle protection sleeve 3 in the distal direction. A cam 1c, which is resiliently arranged on the syringe holder 1 and is formed by the syringe holder 1, can engage in this slot-shaped recess, or alternatively in another recess of the needle protection sleeve 3. The cam 1c is designed such that when an attempt is made to move the needle protection sleeve 3 from the starting position into the actuated position, the cam 1c initially prevents the needle protection sleeve 3 from being moved, wherein the cam 1c is pushed out when the force applied to the needle protection sleeve 3 for pushing it back exceeds a certain threshold value, whereby the needle protection sleeve 3 is suddenly pushed back into the actuated position. The needle 13a can thus be suddenly inserted into the puncture site.To insert the needle 13a or to move the needle protection sleeve 3 into the actuated position, the distal end of the needle protection sleeve 3 is placed into the puncture site, wherein the housing 2 is then pressed towards the puncture site, wherein when the pressing force exceeds the above-mentioned threshold value, the housing 2 is suddenly moved towards the puncture site and the needle protection sleeve 3 is moved relative to the housing 2 into the actuated position.

[0059] The housing 2 has a cylindrical holding section or cylinder section 2b, which in particular surrounds the distal end of the syringe holder 1 in a particularly cylindrical manner and bears against it, whereby the at least one shoulder 1b is held in engagement with the tapered region of the syringe body. Furthermore, the housing 2 has, in the region of the holding section 2b, a translation stop in the form of a holding shoulder 2e, which prevents the syringe holder 1 from being displaced in the distal direction relative to the housing 2 when the syringe holder 1 bears against the holding shoulder 2e. This also advantageously applies to the variants described. Furthermore, the cylindrical holding section 2b can have grooves 2d, which, in conjunction with rails 3c attached to the inside of the needle protection sleeve 3, form an anti-twist device for the needle protection sleeve 3.

[0060] The auto-injector further comprises a sleeve-shaped propulsion member 7; 7' ( Fig.8 ; Fig.9), which at its distal end forms ribs 7c, 7c' projecting inwards and in the longitudinal direction, on which a first spring 9, which can also be referred to as a dispensing spring, is supported. The first spring 9 is arranged within the sleeve-shaped propulsion member 7; 7'. The length of the ribs 7c; 7c' is designed such that the installation space for the first spring 9, which is a helical spring acting as a compression spring, is reduced and thus the spring 9 is pretensioned with so much energy in the initial or delivered state of the auto-injector that it can dispense the product contained in the product container 13, in particular completely by moving the propulsion member 7; 7' by a dispensing stroke HA from the product container 13. In addition, the ribs 7c, 7c' form a reinforcement of the base of the propulsion member 7; 7', so that the distal region of the propulsion member 7; 7' does not break through due to the high forces of the discharge spring 9.The length of the ribs 7c; 7c' can vary in different auto-injectors, whereby the corresponding length of the ribs of the propulsion element 7; 7' can be used to adjust the spring tension of the first spring, which is identical in the various auto-injectors. For example, longer ribs can generate a higher spring preload to dispense a more viscous fluid. Thus, two auto-injectors can be formed that are identical except for the rib length but with different spring preload. Only one rib 7c; 7c' can also be provided in the corresponding propulsion element 7; 7'. In the delivered state of the device, there is a distance between the piston 13b and the distal end of the propulsion element 7, so that the propulsion element 7 only strikes the piston 13b during the execution of the dispensing stroke HA and carries it along in the dispensing direction.

[0061] The first spring 9 is supported with its proximal end on a holding element 6, which in this example has two arms 6c, with a first engagement element 6a and a second engagement element 6b arranged on each arm 6c. The first engagement element 6a points radially towards the longitudinal axis L, with the second engagement element 6b pointing radially away from the longitudinal axis L. The first engagement element 6a engages in a first recess 7a formed by the propulsion element 7, thereby preventing movement of the propulsion member 7 relative to the holding element 6 in the distal direction or in the dispensing direction. This holds the first spring 9 in its tensioned state. The holding element 6 has a guide pin 6d, which is inserted through the proximal end of the first spring 9 into the core of the spring 9. The guide pin 6d prevents lateral buckling of the first spring 9 during and at the end of the discharge stroke HA of the propulsion link 7.

[0062] The auto-injector has a switching module 8, 15, which has a switching sleeve 15 and a locking sleeve 8 surrounded by the switching sleeve 15. In the delivery state of the device, the first engagement element 6a is held in engagement with the first recess 7a by the inner circumference of the locking sleeve 8, which bears against the second engagement element 6b.

[0063] The switching sleeve 15 is connected to the proximal end 3a of the needle protection sleeve 3 or at least rests against the proximal end 3a of the needle protection sleeve 3. A second spring 10, within which the first spring 9 is arranged and which preferably at least partially surrounds the switching sleeve 15 and the locking sleeve 8, rests with its distal end on the switching sleeve 15. A part of the switching sleeve 15 is thus arranged between the needle protection sleeve 3 and the distal end of the second spring 10. The second spring 10 is a metal spring acting as a compression spring and designed as a helical spring. The second spring 10 rests with its proximal end on a signaling element 11, in particular on a projection 11c, which engages the housing 2 in an axially displaceable and rotationally fixed manner and which extends through a slot-shaped groove 5b of the mechanism holder 5. The second spring 10 thus also surrounds the mechanism holder 4 at least partially, preferably completely.

[0064] The switching element 15 has a recess 15a into which a locking element 8a of the locking sleeve 8 engages. The locking element 8a is sawtooth-shaped and protrudes radially from the longitudinal axis L. The locking element 8a is resiliently arranged on an arm formed by the locking sleeve 8. By displacing the switching sleeve 15 in the proximal direction, the locking sleeve 8 is driven in the proximal direction via the engagement of the locking element 8a.

[0065] By moving the needle protection sleeve 3 into the actuated position, the switching sleeve 15 is also moved along by the actuation stroke HB, thereby tensioning the second spring 10. If the needle protection sleeve 3 is not fully moved into the actuated position, the second spring 10 can move the switching sleeve 15 and the needle protection sleeve 3 back to the starting position, whereby the locking sleeve 8 is also moved along by the switching sleeve 15 via the engagement of the locking member 8a.

[0066] The particularly sleeve-shaped signaling member 11 is in axially fixed engagement with the propulsion member 7 in the delivery state or before the product dispensing is triggered. The signaling member 11 has a first engagement member 11a, which engages in a recess 7b of the propulsion member 7, and a second engagement member 11b. The first engagement member 11a and the second engagement member 11b are resiliently arranged at the end of an arm 11d. The signaling member 11 has two such arms 11d with a first engagement member 11a and a second engagement member 11b. The first engagement member 11a points radially toward the longitudinal axis L, with the second engagement member 11b pointing radially away from the longitudinal axis L. In the delivery state, the first engagement member 11a is held in axially fixed engagement with the propulsion member 7 by the inner circumference of the locking sleeve 8.In alternative embodiments, the recess 7b can be designed in such a way, in particular a recess 7b extending in the longitudinal direction, that during a first partial stroke of the dispensing stroke, an axial relative movement takes place between the propulsion member 7 and the signaling member 11, and during a second partial stroke of the dispensing stroke, the first engagement member 11a is held in axially fixed engagement with the propulsion member 7, at least in the distal direction. The second engagement member 11b bears against the inner circumference of the switching sleeve 8. The closure cap 12 has a signal stop 12b, against which the signaling member 11 can strike to generate a signal and preferably against which the signaling member 11 bears in the as-delivered state of the device.

[0067] To administer the product from the product container 13, the pull-off cap 4 is removed from the auto-injector together with the rigid needle shield 14. The distal end of the needle shield 3 is placed against the puncture site of a patient, whereby the housing 2 is displaced towards the puncture site, whereby the needle shield 3 moves from its initial position by the actuation stroke HB in the proximal direction relative to the housing 2 into the actuated position. This tensions the second spring 10, whereby the switching sleeve 15 is driven by the needle shield 3 by the actuation stroke HB. The locking sleeve 8 has a first recess 8b, which is brought into the position of the second engagement element 6b by displacing the locking sleeve 8 by the actuation stroke HB along the longitudinal axis L, as shown in the Figures 3a-3cAs a result, the first engagement element 6a is moved out of engagement with the propulsion member 7 with a movement transverse to and away from the longitudinal axis L, while simultaneously the second engagement element 6b is moved into engagement with the locking sleeve 8, in particular its first recess 8b. This releases the propulsion member 7 for movement by the discharge stroke HA in the discharge direction.

[0068] Since the axially fixed coupling between the propulsion member 7 and the holding element 6 is now removed, the holding element 6, which is movable at least a short distance relative to the housing 2 and along the longitudinal axis L, can be moved by the first spring 9 in the proximal direction, wherein the holding element 6, via the engagement of the second engagement element 6b in the recess 8b, moves the locking sleeve 8 by a start signal stroke HK ( Figure 3c), whereby the locking sleeve 8 strikes a start signal stop 5a formed by the mechanism holder 5, and thereby emits an acoustic and / or tactile signal which signals to the user of the device that the product dispensing has started. By displacing the locking sleeve 8 by the actuating stroke HB, the locking member 8a is released for movement transversely and towards the longitudinal axis L, since the mechanism holder 5 has a recess 5d which permits such a movement of the locking member 8a when the locking sleeve 8 has been displaced by the actuating stroke HB or when the needle protection sleeve 3 is in its actuated position.

[0069] Since the signal element 11 is still axially fixed to the propulsion element 7, it is driven by a first partial stroke HS of the discharge stroke HA in the discharge direction, whereby the signal element 11 is moved away from the signal stop 12b by approximately the first partial stroke HS, as best seen from Figure 4c can be seen. At the end of the first partial stroke HS, during which the first and second engagement members 11a, 11b are moved relative to the locking sleeve 8, the first engagement member 11a is pressed out of engagement with the propulsion member 7, while at the same time the second engagement member 11b is moved into the second recess 8c of the locking sleeve 8 with a movement transverse to the longitudinal axis L and radially away from the longitudinal axis L. This prevents the signal member 11 from moving in the proximal direction relative to the housing 2 or the locking sleeve 8. The second engagement member 11b is held in engagement with the recess 8c by the outer circumference of the propulsion member 7 ( Figure 4a ) when the propulsion member 7 is moved by its second partial stroke of the discharge stroke HA. The outer peripheral surface of the propulsion member 7 holds the second engagement element 6b in engagement with the first recess 8b of the locking sleeve 8, as best seen from Figure 4b can be seen. At the end of the dispensing stroke HA, the propulsion member 7 releases the second engagement member 11b from engagement with the locking sleeve 8, whereby the second engagement member 11b is moved out of engagement with the recess 8c, in particular towards the longitudinal axis L, so that the second spring 10 accelerates the signaling member 11 against the dispensing direction, ie in the proximal direction, so that when the signaling member 11 hits the signal stop 12b, an acoustic and / or tactile signal is generated.

[0070] How best to Figure 5bAs can be seen, the engagement of the second engagement element 6b in the first recess 8b remains, whereby a movement of the locking sleeve 8 in the distal direction relative to the housing 2 is prevented.

[0071] By removing the auto-injector from the injection site, the second spring 10 can move the switching sleeve 15 and the needle protection sleeve 3 from the actuated position to the needle protection position by the needle protection stroke HN, whereby the locking member 8a is pressed out of engagement with the recess 15a, whereby the switching sleeve 15 moves in the distal direction relative to the locking sleeve 8. When the needle protection sleeve 3 is in its needle protection position, the locking member 8a snaps into the switching sleeve 15, whereby the locking member 8a prevents the needle protection sleeve 3 from being pushed back into its actuated position. When attempting to push the needle protection sleeve 3 back from the needle protection position to the actuated position, the switching member 15 abuts the locking member 8a, which prevents the needle protection sleeve 3 from moving into the actuated position. For this purpose, the locking sleeve 8 is supported axially on the start signal stop 5a of the mechanism holder 5. List of reference symbols

[0072] 1 syringe holder 8 locking sleeve 1a Ablation / holding member 8a locking link 1b Shoulder / intervening limb 8b first recess 1c cam 8c second recess 2 Housing 2a recess 9 first spring / discharge spring 2b Cylinder section / holding section 10 second spring / needle protection spring 2c Actuating stop 2e Holding shoulder 11 signal element 2d grooves 11a first engaging element 11b second engagement element 3 Needle protection sleeve 11c excavation 3a proximal end 11d arm 3b Snap geometry 3c rails 12 cap 12a locking element 4 pull-off cap 12b Signal stop 4a snap hook 4b Snapper 13 Product container / syringe 13a needle 5 Mechanism holder 13b Pistons 5a Start signal stop 5b Groove 14 rigid needle shield / needle protection cap 5c Retaining spring section 5d Deepening 15 Switch sleeve 15a recess 6 Holding element 6a first engagement element HA Discharge stroke 6b second engagement element HB Actuating stroke 6c arm HS Signal stroke / first partial stroke 6d guide pin HK Start signal stroke HN Needle protection stroke 7; 7' Propulsion link HM Assembly stroke 7a first recess 7b second recess L Longitudinal axis 7c; 7c' ribs

Claims

1. Autoinjector for dispensing a liquid product, in particular a drug, comprising: a) a housing (2) and a product container (13) arranged in the housing (2), in particular a syringe, which has a movable plunger (13b), the plunger (13b) being movable in a dispensing direction in order to dispense the product contained in the product container (13), b) a propulsion element (7; 7') which acts on the plunger (13b) during product dispensing, and a first spring (9) which acts on the propulsion element (7; 7'), c) a needle protection sleeve (3) which, in order to trigger the product dispensing, is movable from its starting position relative to the housing (2) and along a longitudinal axis (L) of the autoinjector in the proximal direction, in particular by an actuating stroke (Hs), as a result of which a second spring (10) is tensioned and in particular the product dispensing is triggered, the needle protection sleeve (3) acting on the second spring (10), characterized in that d) the housing (2) comprises a retaining portion, the retaining portion of the housing projecting in the distal direction beyond a distal end of the housing, and the retaining portion of the housing (2) having one or more grooves (2d) or alternatively one or more rails which, in conjunction with a rail or rails (3c) provided on the needle protection sleeve (3) or alternatively in conjunction with a groove or grooves provided on the needle protection sleeve (3), form an anti-rotation element between the housing (2) and the needle protection sleeve (3), and e) the propulsion element (7; 7') has, on an inner side, an inwardly projecting rib (7c; 7c') or inwardly projecting ribs (7c; 7c') for adjusting a spring tension of the first spring (9), the length of the rib (7c; 7c') or the ribs (7c; 7c') determining a pretensioning of the first spring (9) such that it can dispense the product from the product container (13b) by moving the propulsion element (9) by a dispensing stroke (HA).

2. Autoinjector according to claim 1, characterized in that the retaining portion of the housing (2) is sleeve-shaped and is arranged in the interior of the housing (2).

3. Autoinjector according to claim 1 or 2, characterized in that the groove (2d) or the rail of the retaining portion of the housing (2) is arranged on an outer lateral surface of the retaining portion of the housing (2).

4. Autoinjector according to any of the preceding claims, characterized in that the groove or the rail (3c) of the needle protection sleeve (3) is provided on an inner lateral surface of the needle protection sleeve (3).

5. Autoinjector according to any of the preceding claims, characterized in that a stop for limiting the axial movement of the needle protection sleeve (3) in the proximal direction is provided between the sleeve-shaped retaining portion of the housing (2) and the sleeve-shaped housing (2).

6. Autoinjector according to any of the preceding claims, characterized by a switching module (8, 15) which is arranged kinematically and / or geometrically between the second spring (10) and the needle protection sleeve (3), the switching module (8, 15) being entrained by the needle protection sleeve (3) in the proximal direction when the needle protection sleeve (3) is moved from its starting position in the proximal direction.

7. Autoinjector according to claim 6, characterized in that the switching module (8, 15) has a switching sleeve (15) and a blocking sleeve (8), the blocking sleeve (8) having a unidirectionally acting locking element (8a) which engages in the switching sleeve (15), and the switching sleeve (15), during its movement relative to the housing (2) in the proximal direction, entraining the blocking sleeve (8) via the locking element (8a) and, during its movement relative to the housing (2) in the proximal direction, being moved relative to the blocking sleeve (8) into a further blocking position in which the locking element (8a) blocks a movement of the switching sleeve (15) relative to the blocking sleeve (8) in the proximal direction.

8. Autoinjector according to any of the preceding claims, characterized in that, after the product has been dispensed, in particular when the propulsion element (7; 7') has been moved by the dispensing stroke (HA) in the distal direction, the needle protection sleeve (3) can be moved by the second spring (10) relative to the housing (2) in the distal direction, in particular by a needle protection stroke (Hs), into a needle protection position in which the needle protection sleeve (3) is positioned distally above the needle tip of an injection needle (13a) of the product container (13).

9. Autoinjector according to claim 8, characterized by a locking element (12a) which locks the needle protection sleeve (3) in its needle protection position relative to the housing (2) against being pushed back in the proximal direction, in particular locks it at least in such a way that the needle tip cannot protrude from the distal end of the needle protection sleeve (3).

10. Autoinjector according to any of the preceding claims, characterized by a signal element (11), a signal stop (12b) and the second spring (10), which exerts a spring force acting counter to the dispensing direction on the signal element (11), the signal element (11) being axially fixedly coupled to the propulsion element (7; 7'), so that the signal element (11) is entrained during the movement of the propulsion element (7; 7') in the dispensing direction and the second spring (10) is tensioned, wherein the axially fixed coupling between the signal element (11) and the propulsion element (7; 7') can be released and the signal element (11) can be accelerated counter to the dispensing direction and relative to the propulsion element (7; 7') and / or the housing (2) by means of the second spring (10), wherein the signal element (11) which is decoupled from the axially fixed coupling with the propulsion element (7; 7') and is accelerated by the second spring (10) strikes against the signal stop (12b), as a result of which an acoustic and / or tactile signal is generated.

11. Autoinjector according to claim 10, characterized in that the signal element (11) has a first engagement element (11a) which releasably engages in the propulsion element (7; 7'), as a result of which the propulsion element (7; 7') is axially fixedly coupled to the signal element (11), the axially fixed coupling between the propulsion element (7; 7') and the signal element (11) being released when the signal element (11) is out of engagement with the propulsion element (7; 7').

12. Autoinjector according to claim 10 or 11, characterized in that the signal stop (12b) is formed by the housing (2) or an element (12) connected to the housing (2) in an at least axially fixed, preferably also rotationally fixed manner, such as a sealing cap (12) which closes the proximal end of the housing (2).

13. Autoinjector according to any of claims 10 to 12, characterized in that the signal stop (12b) is arranged along the longitudinal axis (L) of the autoinjector, in particular of the housing (2), in alignment with the signal element (11).

14. A first and a second autoinjector according to any of the preceding claims, characterized in that the length of the rib or ribs (7c) of the first autoinjector is different from the length of the rib or ribs (7c') of the second autoinjector, and in that the autoinjectors are otherwise identical.