AUTO INJECTOR WITH SYRINGE HOLDER WITH SPRING-CONTROLLED SHOULDER

Description

[0001] 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 an improved syringe holder according to claim 1. Advantageous further developments will become apparent from the dependent claims, the description, and the figures.

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

[0003] Furthermore, injection devices, in particular autoinjectors, are known from DE 10359694 A1 and WO 2004 / 047892 A1, which have a needle guard sleeve supported by an untensioned needle guard spring. During the automatic insertion of the needle, the needle guard spring is tensioned. After the injection device is removed from the insertion site, the now tensioned spring can push the needle guard sleeve distally over the needle tip. In addition, autoinjectors with syringe holders are known from WO 2007 / 083115 A1 and WO 2013 / 016832 A1.

[0004] The autoinjector according to the invention comprises a housing and a product container arranged within the housing. The product container can, in particular, be a syringe having a syringe body at the distal end of which an injection 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 to dispense the product, thereby dispensing the liquid product, in particular medication, located between the piston and the injection needle, 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 the end opposite the injection needle.A syringe designed in this way is available as a standard syringe, so it is not absolutely necessary to develop a specially adapted syringe for the autoinjector. The plunger seals tightly against the inner diameter of the syringe barrel.

[0005] 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. The product container is arranged within the housing. For example, the container can be slidably arranged within the housing, i.e., it can be displaceable relative to the housing in a distal direction 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 relative to the housing in a proximal direction.

[0006] According to the invention, the product container is immovably held in the housing along its longitudinal axis by means of a product container holder or syringe holder, which axially secures the product container and is axially fixed to the housing, in particular 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 injection needle, through which the needle can pass. In its initial position relative to the needle tip, the needle guard can be arranged 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 in the distal direction by one needle guard stroke into a needle guard position in which the distal end of the needle guard sleeve extends distally beyond the needle tip, thus reducing the risk of injury from an exposed needle tip after use of the device or after product dispensing. The needle guard sleeve can, for example, be displaced in the proximal direction against the force of a spring, which can be referred to as a needle guard spring, wherein the spring, which, for example,The second spring described below, or a separate spring, is capable of moving the needle guard sleeve from the actuated position distally, i.e., into the needle guard position. The autoinjector may have a locking element, e.g., a spring-loaded one, which locks the needle guard sleeve in its needle guard position, particularly with respect to the housing, and prevents the needle guard sleeve from being moved back proximally or into the housing. The locking element 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 proximally to the point where the needle tip does not protrude from the distal end of the needle guard sleeve.

[0007] The autoinjector further comprises a propulsion element that acts on the piston, at least during product dispensing, and in particular bears against the piston, and a first spring that acts on the propulsion element, for example, by bearing against the propulsion element with its distal end. The propulsion element can, for example, be sleeve-shaped and form a shoulder, which is arranged, for example, in the region of the distal end of the propulsion element, against which the distal end of the first spring can bear. The first spring is preferably arranged inside the sleeve-shaped propulsion element. The 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 a high degree, particularly in the delivery state of the autoinjector, that it...The energy stored in the actuator is sufficient to essentially empty the product completely from the product container by moving the actuator by one discharge stroke. Moving the actuator by this discharge stroke also moves the piston. If there is a gap between the piston and the actuator in the delivery state, the piston's discharge stroke is smaller than the discharge stroke of the actuator, which 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 delivery state and not only during product discharge. If the actuator is already in contact with the piston in the delivery state, the piston's discharge stroke corresponds to the discharge stroke of the actuator.The proximal end of the first spring, which can also be called a disengagement spring due to its function, can be supported on the housing or a housing-fixed element, in particular also an element that is only temporarily axially fixed to the housing.

[0008] Preferably, the autoinjector comprises a signal element, a signal stop, and a second spring. The second spring can exert a spring force on the signal element acting against the discharge direction or in the proximal direction. In particular, the second spring can, for example, be supported at its proximal end against the signal element.

[0009] The second spring can be, for example, a helical spring acting as a compression spring, with its proximal end supported against the signal element. The spring can be supported at its distal end, for example, against the housing or a housing-mounted element. Particularly preferably, the second spring is supported at its distal end against the needle guard sleeve or 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 switching module or a switching sleeve, as described below. The element can be arranged, in particular kinematically and / or geometrically, between the needle guard sleeve and the distal end of the second spring. The advantage here is that the needle guard sleeve can be displaced from its actuated position to the needle guard position by means of the second spring.The spring can therefore preferably fulfill a dual function, as it also exerts the aforementioned force on the signal element.

[0010] Particularly in the delivery state or during the first partial stroke of the discharge stroke of the drive element, the signal element can be axially fixed to the drive element, so that the signal element is displaceable with the drive element along its longitudinal axis and, in particular, relative to the housing, especially in the distal direction. This axially fixed coupling to the drive element causes the signal element to be carried along during the movement of the drive element in the discharge direction, particularly during the execution of the first partial stroke of the discharge stroke, and thus tensions the second spring. During a second partial stroke of the discharge stroke, it is preferred that the axially fixed coupling between the signal element and the drive element is released. The axially fixed coupling between the signal element and the drive element is therefore releasable.When the axially fixed coupling between the signal element and the drive element is released—and, in particular, when no further couplings exist between the signal element and any other element, as described below—the signal element can be accelerated by means of the second, pre-tensioned spring in the opposite direction of discharge and relative to the drive element and / or the housing. Due to the drive element carrying the signal element along by the first partial stroke, a gap is formed between the signal stop and the signal element, extending, for example, along the longitudinal axis, and corresponding in particular to the first partial stroke. The second spring can accelerate the signal element over this distance, causing the signal element to strike the signal stop at a velocity sufficient to impart an impulse to the signal element, generating an acoustic (audible) and / or tactile (perceptible) signal.

[0011] 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 cap at the proximal end of the housing and / or form the proximal end of the autoinjector. The cap can preferably be positively connected to the housing, or alternatively, force-fit or material-fit. Preferably, the element is snapped into the housing. A separate cap has the advantage of simplifying the assembly of the device, whereby, for assembly, at least some of the components are inserted 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 located on the cap, whereby the perceived sound of the acoustic signal can be modified within certain limits by adjusting the material thickness and shape of the cap.

[0012] In preferred embodiments, the signal element comprises a first engagement element, in particular a resilient one, and / or one arranged on a resilient arm, which engages releasably in the thrust element, in particular in a recess of the thrust element. This axially couples the thrust element to the signal element. The axially fixed coupling between the thrust element and the signal element is released when the signal element, in particular the first engagement element, is disengaged from the thrust element, in particular from the recess of the thrust element. Specifically, the first engagement element is released from engagement with the thrust element at the end of the first partial stroke of the thrust element.

[0013] Preferably, the signal stop is arranged along the longitudinal axis of the autoinjector such that it is in line with the signal element. This ensures that the signal element strikes the signal stop when moving along the longitudinal axis of the autoinjector.

[0014] In embodiments with a needle guard sleeve, it is preferred that the needle guard sleeve acts on the second spring, wherein the needle guard sleeve 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, to trigger the product dispensing. This tensions the second spring and preferably also triggers the product dispensing, in particular the movement of the propulsion element 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 has been dispensed, particularly after a short waiting period, such as 3 to 10 seconds, following the generation of the signal by the signaling element, 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 second spring. Removing the autoinjector from the injection site also withdraws the needle.

[0015] In certain embodiments, a switching module can be kinematically arranged between the second spring and the needle guard sleeve. The switching module 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, and the needle guard sleeve is moved in the distal direction when the spring acting on the switching module moves the switching module in the distal direction. The switching module, or a part thereof, such as a switching sleeve, can be integral with the needle guard sleeve, or be positively connected to it, for example, by snapping, or simply rest against the needle guard sleeve. The switching module can be a single part or comprise several parts, with a multi-part switching module comprising at least the switching sleeve and a locking sleeve. The locking sleeve can be, for example, positioned relative to the needle guard sleeve and / or switching sleeve by means of a locking mechanism.The components may be displaceable along the longitudinal axis. For example, the spring may be supported on the switching sleeve and the switching sleeve on the needle guard sleeve. A locking element, preferably the aforementioned locking element that locks the needle guard sleeve in its needle guard position, may be provided between the locking sleeve and the switching sleeve. This locking element may be formed, for example, by the locking sleeve and engage in the switching sleeve, particularly in a recess.The locking element is preferably designed such that, during its movement relative to the housing in the proximal direction, the switching sleeve carries the locking sleeve along with it, particularly during the movement of the needle guard sleeve from its initial position to the actuated position, and is moved into a locking position relative to the locking sleeve during its movement relative to the housing in the proximal direction, particularly during the movement of the needle guard sleeve from its actuated position to the needle guard position. In the locking position, the locking element, or another locking element such as the one mentioned above, prevents movement of the switching sleeve relative to the locking sleeve in the proximal direction. This advantageously prevents the needle guard sleeve from being pushed back into the housing from its needle guard position to allow the needle tip to be released again.

[0016] For example, the switching sleeve can have a first recess into which the locking element of the locking sleeve releasably engages when the needle guard sleeve is moved from its initial position to its actuated position. For example, the switching sleeve can have a second recess into which the locking element, or optionally the other locking element, engages when the needle guard sleeve is in its needle guard position. The first and second recesses can preferably be arranged along the longitudinal axis at a distance from each other approximately corresponding to the needle guard stroke. Of course, a reversal of the arrangement of the recesses and the locking element(s) is also possible, i.e., that the at least one locking element can be located on the switching sleeve and the at least one recess, i.e., the first recess and optionally the second recess, can be located on the locking sleeve.

[0017] The locking element and, if applicable, the other locking element can be resiliently arranged, in particular each on a resilient arm. Preferably, the switching sleeve can surround and / or guide the locking sleeve.

[0018] In preferred embodiments, the signal element can have a second engagement element which, by the disengagement movement of the first engagement element (with which the first engagement element disengages from the drive element), can be moved into an engagement, particularly axially fixed, with the needle guard sleeve or the switching module, especially the locking sleeve. The first engagement element and the second engagement element are preferably coordinated such that the second engagement element is already engaged, preferably axially fixed, in the needle guard sleeve or the switching module when the first engagement element has not yet completely disengaged from the drive element. This advantageously and reliably prevents the first engagement element from already being disengaged from the drive element when the second engagement element is not yet engaged with the needle guard sleeve or the switching module.The needle guard sleeve or the switching module, in particular the locking sleeve, may have, for example, a further recess into which the second engagement element of the signal element engages, e.g., for the axially fixed coupling between the signal element and the switching module, in particular the locking sleeve, or the needle guard sleeve. The drive element may have a recess into which the first engagement element engages for the axially fixed coupling between the drive element and the signal element. Preferably, the first engagement element and the second engagement element are formed on a common elastic arm, wherein the first engagement element points, e.g., radially towards the longitudinal axis and the second engagement element points, e.g., radially away from the longitudinal axis. The first and second engagement elements can be arranged, preferably radially, between the drive element and the needle guard sleeve or the switching module, in particular the locking sleeve.

[0019] In particular, during the discharge stroke of the thrust member, especially at the end of the first partial stroke, the first engagement member is released from engagement with the thrust member and, preferably simultaneously, the second engagement member is brought into engagement with the switching module or the needle guard sleeve, especially with a movement transverse to the longitudinal axis. In particular, the thrust member, by its movement in the discharge direction, can push the first engagement member out of the recess of the thrust member and the second engagement member into the recess of the needle guard sleeve or the switching module, especially the locking sleeve.

[0020] In particularly preferred embodiments, the needle guard sleeve or the switching module, especially the locking sleeve, can hold the first engagement element in engagement with the recess of the drive element, wherein the recess for the second engagement element is moved from its initial position to its actuated position relative to the longitudinal axis towards the second engagement element by moving the needle guard sleeve from its initial position to its actuated position, wherein the recess in the actuated position of the needle guard sleeve, especially at the moment when the discharge stroke is released, is arranged at a distance along the longitudinal axis from the second engagement element that corresponds approximately to the first partial stroke of the signal element. The drive element, released for the discharge stroke by actuating the needle guard sleeve, is then movable by the first partial stroke in the discharge direction.Preferably, the first engagement element is held in engagement with the drive element by the inner circumference of the needle guard sleeve or the switching module, in particular the locking sleeve, against which the second engagement element rests. At the end of the first partial stroke, the second engagement element is in the same position relative to the longitudinal axis as the recess, allowing the second engagement element to engage in its recess and the first engagement element to disengage from its recess.

[0021] The discharge stroke of the thrust member can, in particular, comprise two phases: the first partial stroke and the second partial stroke. During the first partial stroke, the first engagement member is in axially fixed engagement with the thrust member, and the second engagement member is disengaged from axially fixed engagement with the needle guard sleeve or the switching module, in particular the locking sleeve. During the second partial stroke of the discharge stroke, the second engagement member is in axially fixed engagement with the needle guard sleeve or the switching module, in particular the locking sleeve, with the first engagement member disengaged from the thrust member. This advantageously ensures that the thrust member is movable in the distal direction relative to the signal member by means of the first spring and / or that the signal member is not yet released for signal triggering.

[0022] It is generally preferred that the drive element can be moved in the distal direction relative to the signal element, in particular by the second partial stroke, by means of the first spring when the first engagement element is out of engagement with the drive element and the second engagement element is in engagement with the needle guard sleeve or the switching module.

[0023] In preferred embodiments, the second engagement element and the recess for the second engagement element can be arranged along the longitudinal axis of the autoinjector at a distance from each other approximately equal to the sum of the actuating stroke of the needle guard sleeve and the first partial stroke of the drive element, which corresponds approximately to the stroke of the signal element from the signal stop.

[0024] Preferably, the drive element can prevent the second engagement element from disengaging from the axially fixed engagement with the needle guard sleeve or the switching module when the drive element moves distally relative to the signal element, particularly during the second partial stroke of the drive element. The drive element allows the second engagement element to disengage from the engagement with the needle guard sleeve or the switching module at the end of the discharge stroke or the second partial stroke. Once the second engagement element has disengaged from the engagement with the needle guard sleeve or the switching module at the end of the second partial stroke, the signal element is accelerated by the second spring in the opposite direction of discharge and strikes the signal stop. Preferably, the second engagement element is held in engagement with the needle guard sleeve or the switching module by the outer circumference of the drive element against which the first engagement element rests.

[0025] In preferred embodiments, the autoinjector can have a retaining element against 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 against the housing or a housing-fixed element. The retaining element itself can be fixed to the housing or displaceable relative to the housing. The retaining element can have a first engagement element which engages the propulsion element before the product discharge is triggered, thereby preventing the propulsion element from moving in the discharge direction relative to the retaining element and / or the housing. The engagement of the first engagement element in the propulsion element can be released for product discharge. When the engagement is released, the propulsion element is free to move in the discharge direction.The first spring can displace the drive element relative to the retaining element and / or the housing by the discharge stroke in the discharge direction. The drive element can have a recess for the first engagement element of the retaining element, wherein this coupling between the drive element and the retaining element is released when the retaining element, in particular the first engagement element, is disengaged from the drive element, in particular from the recess of the drive element. In particular, the first engagement element can be released from engagement with the drive element by displacing the needle guard sleeve from its initial position by the actuating stroke into the actuated position. For example, the first engagement element can be held in axially fixed engagement with the drive element by the needle guard sleeve or the switching module, in particular 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 the switching module, in particular the locking sleeve, can hold the first engagement element in engagement with the drive element, whereby, for example, a second engagement element, which is described further below, can rest against the inner circumference.

[0026] By moving the needle guard sleeve into its actuated position, the needle guard sleeve or the switching module, in particular the locking sleeve, can allow the first engagement element to disengage from the drive element, especially with a movement transverse to the longitudinal axis of the autoinjector. For example, a recess, in particular for the second engagement element, which is formed on the needle guard sleeve or the switching module, in particular the locking sleeve, can be arranged in the same position relative to the longitudinal axis as the first and / or second engagement element, so that the first engagement element can disengage from the drive element. For example, the drive element can push the first engagement element out of engagement with the drive element when the needle guard sleeve is in its actuated position.

[0027] The first engagement element can, for example, point radially towards the longitudinal axis and / or be arranged on a spring-loaded arm of the retaining element.

[0028] As mentioned, the retaining element can have a second engagement element, which, by the disengagement movement of the first engagement element from the drive member, can be moved into an axially fixed engagement with the needle guard sleeve or the switching module, in particular the locking sleeve. The second engagement element can, for example, be arranged on the arm on which the first engagement element is located and / or, for example, point radially away from the longitudinal axis. The first engagement element and the second engagement element can be coordinated such that the second engagement element already engages axially fixedly in its recess, which is formed by the needle guard sleeve or the switching module, in particular the locking sleeve, when the first engagement element has not yet completely disengaged from the drive member.This advantageously ensures that the axially fixed connection between the retaining element and the needle guard sleeve or the switching module is established first, before the axially fixed connection between the retaining element and the drive element is released, thus preventing the needle guard sleeve from being pushed back again or further.

[0029] Particularly when the second engagement element is in its recess, the drive element can move distally relative to the retaining element, especially due to the energy stored in the pre-tensioned spring. The drive element can prevent the second engagement element from disengaging from the axially fixed engagement with the needle guard sleeve or the switching module, particularly the locking sleeve, if the drive element moves distally relative to the signal element. This preferably also applies at the end of the discharge stroke, especially when the second engagement element of the signal element is released from its recess to be accelerated by the second spring against the discharge direction.

[0030] Particularly in embodiments where the recess for the second engagement element of the retaining element is formed by the needle guard 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 move the needle guard sleeve from the actuated position to the needle guard position after the product has been dispensed. For this purpose, the drive element 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 release the movement of the needle guard sleeve in the distal direction.

[0031] In embodiments with a switching module comprising a switching sleeve and a locking sleeve, it is preferred that the second engagement element remains in position at the end of the discharge stroke such that it prevents the locking sleeve from moving distally relative to the housing and / or the second engagement element. The switching sleeve and / or the needle guard sleeve are displaceable distally relative to the locking sleeve, particularly due to the energy stored in the second spring, thereby moving the needle guard sleeve into its needle guard position. As already described, and noted only for the sake of completeness, the locking element between the locking sleeve and the switching sleeve can engage in a way that prevents the switching sleeve from being displaceable proximally relative to the locking sleeve.Preferably, movement of the locking sleeve in the proximal direction is prevented by the locking sleeve abutting either the housing or a housing-fixed element, such as a mechanical holder, or the signal element.

[0032] The invention relates to the design of a tip holder for an autoinjector in which the product container is immovable with respect to the housing, or for an autoinjector of the type described above.

[0033] The disclosure relates to a syringe module, which is intended in particular for use in an autoinjector. In particular, an autoinjector may be provided which includes 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 slidably arranged in a cylindrical section of the syringe body, wherein the syringe body has a tapered section or area located between the needle-holding section and the cylindrical section. The syringe further has a needle shield, which may, 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, while a rigid needle shield consists of a hard plastic sleeve containing a rubber-elastic plastic sleeve. The rubber-elastic plastic sleeve and the hard plastic sleeve together form the rigid needle shield. The needle guard, which covers the needle and is attached to the needle holder section, which extends conically towards the needle tip, preferably protects the needle from dirt and keeps it sterile. A gap is formed between the tapered section and the needle guard, particularly the hard plastic sleeve.

[0034] The syringe holder has at least one engagement element, in particular a shoulder, against which the tapered section of the syringe is supported 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 against the at least one shoulder prevents the syringe from moving distally relative to the syringe holder.

[0035] It is preferred that there is a gap between the shoulder and the needle shield, so that the needle shield remains free from stress on the shoulder. This advantageously prevents the sterility of the needle from being compromised by unintentional displacement of the needle shield by the shoulder.

[0036] In preferred embodiments, the syringe body can have a finger flange at its proximal end, with a gap formed between the finger flange and the syringe body when the tapered section rests against the shoulder, thus leaving the finger flange essentially unloaded. This advantageously prevents the finger flange from being overloaded and breaking the syringe body.

[0037] It is further preferred that the syringe holder has at least one retaining element, in particular an outwardly directed projection, with which the syringe holder can be axially fixedly connected or connected to a housing of the autoinjector, in particular snapped or snappable.

[0038] In particular, the syringe holder can have at least one cam that is spring-loaded, especially on an arm, and is located, for example, distal to the holding element. The at least one cam can inhibit or prevent a needle guard sleeve from moving from its initial position to its actuated position in such a way that, when a limit force exerted on the needle guard sleeve along the longitudinal axis L of the autoinjector is exceeded, the at least one cam is forced out of engagement with the needle guard sleeve, thereby allowing the needle guard sleeve to be abruptly displaced into its actuated position relative to the housing.

[0039] The housing of the autoinjector can, for example, have a retaining section that rests against the syringe holder, in particular against an outer surface or circumference of the syringe holder, and prevents the at least one engagement element from moving away from the longitudinal axis transversely. In particular, the retaining section can be annular and surround the at least one engagement element, preferably two, three, or four engagement elements, so that the at least one engagement element is arranged within the retaining section. For mounting or inserting the syringe into the syringe holder, the syringe holder is out of engagement with the retaining section of the housing. When the syringe is fully inserted into the syringe holder, in particular when the at least one engagement element engages in the gap between the tapered section and the needle guard, the syringe module or...The syringe holder is brought into engagement with the holding section, so that the at least one engagement element 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.

[0040] In a first embodiment, the at least one engagement element can be resiliently formed, in particular on an arm on the syringe holder, wherein 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 at least one engagement element outwards transversely to the longitudinal axis, i.e., away from the longitudinal axis. When the needle guard has moved completely past the at least one engagement element, the at least one 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 autoinjector housing, thereby holding the at least one engagement element in engagement with the gap between the needle guard and the tapered section and preventing it from springing out of this engagement.

[0041] In further variations, the syringe holder can comprise at least two shell bodies, in particular two half-shells, each preferably having such an engagement element, wherein the engagement element can be rigidly, i.e., essentially immovably, arranged on the shell body. By joining the at least two shell bodies, the at least one engagement element can be inserted into the gap between the needle guard cap and the tapered section of the syringe arranged between the shell bodies, thereby blocking the syringe against movement in the distal direction.

[0042] In particular, two shell bodies can be connected via a pivot joint, wherein the shell bodies can pivot relative to each other from an insertion position, in which the syringe can be inserted into the syringe holder, to a closed position, in which the at least one engagement element engages in the gap between the needle guard cap and the tapered area. The shell bodies can be locked together in the closed position, or alternatively, they can rest loosely against each other, with the retaining section holding the shell bodies together.

[0043] Since the shell bodies are preferably made of plastic, such as transparent plastic, the swivel joint can be a film hinge, so that the first and second shell bodies are connected in one piece via the film hinge.

[0044] Alternatively, the pivot joint can be a hinge having at least one hinge pin and at least one hinge pin receptacle in which the hinge pin is arranged, in particular locked in place, and relative to which the hinge pin is pivotable and / or on which the hinge pin slides when pivoting. For example, the first shell body can have two hinge pins and the second shell body can have two hinge pin receptacles for the two hinge pins. Preferably, the first shell body has one hinge pin and one hinge pin receptacle, and the second shell body also has one hinge pin and one hinge pin receptacle, wherein the hinge pin of one shell body is or can be inserted into the hinge pin receptacle of the other shell body.The advantage here is that the first shell body and the second shell body can be formed identically and joined together by flipping, thus reducing the tooling costs for production.

[0045] The pivot axis of the swivel joint can be parallel or transverse, in particular perpendicular or oblique to, the longitudinal axis of the syringe, especially the injection needle of the syringe. If the pivot axis is parallel to the longitudinal axis, it is preferred that the pivot axis be arranged laterally to the syringe body. If the pivot axis is arranged transversely to the longitudinal axis, it is preferred that the hinge or pivot axis be arranged at the proximal end of the syringe holder.

[0046] In preferred embodiments, the first and second shell bodies can be joined together by a linear movement transverse to the longitudinal axis, and the at least one engagement element can be moved into the gaps between the needle guard cap and the tapered section of the syringe body during assembly, particularly by means of the linear joining movement. The first and second shell bodies can be latched or snapped together on opposite sides with respect to the syringe diameter, or alternatively, they can rest loosely against each other, with the retaining section of the autoinjector housing holding the shell bodies together.

[0047] Preferably, the first shell body and the second shell body are connected in an insertion position, in which the syringe can be inserted into the syringe body, by means of at least one, preferably several, predetermined breaking points, wherein the at least one predetermined breaking point is broken by pressing the first and second shell bodies against each other, whereby the first and second shell bodies are brought into their closing position, in which the at least one engagement element engages in the gap between the needle guard and the tapered area. Before the at least one predetermined breaking point is broken, the first and second shell bodies can be integrally connected to each other, forming a sleeve-shaped body through whose proximal end the syringe, in particular with the needle or needle guard leading, can be inserted.

[0048] Preferably, the first shell body and the second shell body each have at least one projection for connection with the housing and / or the cam for the stop when pushing back the needle guard sleeve.

[0049] In further embodiments, the first shell body can have at least one engagement element and a lateral opening through which the syringe can be inserted laterally into the first shell body, wherein, upon lateral insertion of the syringe into the syringe body, the at least one engagement element is inserted into the gap between the needle guard cap and the tapered section. For example, the first shell body can have at least one projection and / or at least one cam.

[0050] Preferably, the syringe holder has a second, in particular sleeve-shaped, shell body into which the first shell body, together with the syringe, can be inserted with a movement along the longitudinal axis, particularly via the proximal end of the second shell body and preferably with the needle tip or needle guard leading the way. In the embodiment with the second shell body, the second shell body can optionally have at least one projection and / or at least one cam.

[0051] Preferably, the second shell body can have a translation stop against which a translation counter-stop of the first shell body abuts, thus preventing displacement of the first shell body, which is received in the second shell body, relative to the second shell body in the distal direction, i.e., particularly when the first shell body is inserted into the second shell body. The retaining section of the housing can preferably be designed such that the at least one engagement element of the first shell body engages with the tapered region and preferably also abuts the region of the second shell body where the translation stop is formed.

[0052] In further preferred embodiments, the syringe holder can have at least one first sleeve-shaped shell body, in particular a sleeve-shaped base body, and at least one, preferably two, pivot levers, wherein the pivot lever is pivotably arranged on the first shell body by means of a hinge about a pivot axis. The pivot axis can preferably extend transversely to the longitudinal direction of the syringe, and preferably be skewed with respect to the longitudinal axis of the syringe. The engagement element can be arranged on the pivot lever, or, in the case of several pivot levers, preferably on each of the several pivot levers, in particular at the end of the pivot lever furthest from the pivot axis. Preferably, the engagement element is arranged distal to the pivot joint. The pivot joint can be a film hinge connecting the pivot lever and the first sleeve-shaped shell body.Alternatively, the pivot joint can be a hinge having at least one hinge pin and at least one hinge pin receptacle in which the hinge pin is arranged, in particular locked in place, and relative to which the hinge pin is pivotable and / or on which the hinge pin slides when pivoting. Preferably, the pivot lever can have two hinge pins and the sleeve body can have two hinge pin receptacles for the hinge pins of the pivot lever, or vice versa. If several pivot levers are present, several such hinge pin receptacles can be provided accordingly.

[0053] Preferably, the retaining section of the housing can act on the at least one pivot lever, in particular bear against the at least one pivot lever, such that the engagement element is held in engagement with the tapered area of ​​the syringe body. When the syringe is inserted over the proximal end of the sleeve body with the needle or needle cap leading, the at least one engagement element is pivoted outwards, allowing the needle cap to move past the at least one engagement element so that the at least one engagement element can engage in the gap when the gap is in the position of the at least one engagement element with respect to the longitudinal axis.

[0054] Preferably, the cam for the needle guard sleeve can be formed on the pivot lever. In particular, the pivot lever can be a two-armed pivot lever, with the cam formed on one arm, which preferably projects proximally from the pivot joint, and the at least one engagement element formed on the other arm, which preferably projects distally from the pivot joint. If the retaining section of the housing holds the pivot lever in engagement with the tapered area, the pivot arm on which the cam is located can be elastically deformed when the needle guard sleeve is pushed back.

[0055] The disclosure content has 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 within the scope of protection of the claims of the invention, both individually and in any combination thereof. The figures show: Figure 1 shows an exploded view of an autoinjector according to a particularly preferred embodiment; Figures 2a-2c show the autoinjector made of Figure 1 in a delivery condition, whereby the Figures 2a to 2c Sectional views passing through the longitudinal axis of the device, wherein the sectional views are angularly offset about the longitudinal axis, Figures 3a-3c show the device and the views from the Figures 2a-2c , wherein a needle guard sleeve is in its actuated position, Figures 4a-4c the device and the views from the Figures 2a-2c, wherein the thrust 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 thrust member at the end of its discharge stroke, Figures 6a-6c the device and the views from the Figures 2a-2c , wherein a signal indicating the end of product dispensing is generated, Figures 7a-7c the device and the views from the Figures 2a-2c, with the needle guard sleeve in its needle guard position, Figures 8a-8d perspective views of a multi-part syringe holder according to a first variant, Figures 9a-9c perspective views of a syringe holder according to a second variant, Figures 10a-10d perspective views of a syringe holder according to a third variant, and Figures 11a-11c perspective views of a syringe holder according to a fourth variant. Figures 12a-12c perspective views of a syringe holder according to a fifth variant. Figures 8e, 9d, 10e, 11d, 12d longitudinal sections of the five embodiments in the delivered state and for embodiments two to five in one position each with a partially and fully inserted syringe.

[0056] Referring to the Figures 1-7c The structural features and function of the preferred autoinjector will now be described.

[0057] The autoinjector has a sleeve-shaped, elongated housing 2 with a longitudinal axis L, which has a cap 12 at its proximal end. The cap 12 is positively connected to the housing 2 in a rotationally and axially fixed manner and forms the proximal end of the autoinjector. The cap 12 snaps onto the housing 2. For this purpose, the cap 12 has a locking element 12a which engages in a recess 2a on the housing 2, preferably such that the cap 12 cannot be removed from the housing 2, or not easily.

[0058] At the distal end of the autoinjector, in its delivered 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.

[0059] A product container 13 in the form of a syringe is held immovably within the housing 2 along its longitudinal axis L, except for the mounting of the autoinjector. The product container 13 has a sleeve-shaped syringe body that surrounds a piston 13b, which seals against the inner circumference of the syringe body. At its distal end, the syringe body has an injection needle 13a, 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 injection needle 13a and the piston 13b. By moving the piston 13b in a discharge direction, i.e., distally or towards the injection needle 13a, the liquid product is discharged from the product container 13 through the hollow injection needle 13a.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.

[0060] The product container 13 is held in a product container holder, referred to as syringe holder 1, such that it is secured at least against movement along the longitudinal axis L in a distal direction relative to the syringe holder 1. The syringe holder 1 is, as best seen from Figure 2a As can be seen, the housing 2 is positively connected, in particular by a locking mechanism. The housing 2 has recesses for this purpose, into which locking elements, formed here at the proximal end of the syringe holder 1, engage. The syringe holder 1 has at least one inwardly projecting shoulder 1b, against which a tapered section of the product container 13, distal to the cylindrical syringe body section that guides the plunger 13b, is supported.

[0061] To prevent the product container 13 from being displaceable 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 retainer acting on the syringe body. The retainer is formed by a retaining spring section 5c of a mechanical retainer 5. The mechanical retainer 5 is arranged, in particular, so that it is immovably and / or rotationally fixed to the housing 2 along the longitudinal axis L. The sleeve-shaped mechanical retainer 5 may be snapped to the housing 2. The retaining spring section 5c compensates for length differences in the product container 13 that may arise due to manufacturing tolerances, thereby ensuring that the product container 13 is firmly seated against the shoulder 1b.

[0062] The product container 13 is positioned relative to the housing 2 such that the needle tip protrudes distally beyond the distal end of the housing 2. In the initial or delivery state of the autoinjector, i.e., when the pull-off cap 4 is attached to the autoinjector, the needle 13a is covered by a needle shield 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, 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, with the tapered section of the syringe body located between the needle-holding section and the cylindrical section of the syringe body.The shoulder 1b is positioned 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 to prevent the shoulder 1b from exerting a force on the rigid needle shield 14, which could, for example, compromise the sterility of the needle 13a or the liquid product. The pull-off cap 4 is detachably snapped to the housing 2 or a needle guard sleeve 3, with this snap being released when the pull-off cap 4 is removed from the housing 2 or the needle guard sleeve 3. In the example shown, the snap is formed by a snap geometry 3b of the needle guard sleeve 3 and a snap hook 4a of the pull-off cap 4. Figure 2bThese snap hooks 4a further secure the pull-off cap 4 against proximal movement relative to the housing 2 by providing a housing-fixed support on the housing 2 or on a distal end face of the syringe holder 1. The pull-off cap 4 also has, in particular on each snap hook 4a, at least one catch 4b which engages in a gap between the syringe body, especially its tapered region, and the proximal end of the rigid needle shield 14. When the pull-off cap 4 is removed from the autoinjector, the catch 4b engages in the proximal end of the rigid needle shield 14, thereby releasing the rigid needle shield 14 from the product container 13 and removing it from the autoinjector together with the pull-off cap 4.

[0063] The autoinjector has a needle guard sleeve 3 which, relative to the housing 2 and along the longitudinal axis L, can be displaced by an actuation stroke HB in the proximal direction into an actuated position to trigger product discharge. In the initial position of the needle guard sleeve 3, as shown in the Figures 2a-2cAs shown, with the pull-off cap 4 removed, the distal end of the needle guard sleeve 3 projects distally beyond the needle tip of the needle 13a, thus initially preventing access to the needle tip. By moving the needle guard sleeve 3 by the actuation stroke HB, the needle guard sleeve 3 is shifted in the proximal direction to such an extent that the needle 13a emerges from the distal end of the needle guard sleeve 3, in particular with a length corresponding to the injection depth of the needle into the puncture site. Preferably, the needle 13a should project sufficiently beyond the distal end of the needle guard sleeve 3 to allow for subcutaneous injection. In particular, the housing 2 can form a stop 2c against which the needle guard sleeve 3 rests in the actuated position.

[0064] After the injection has taken place, 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 HN in the distal direction into a needle guard position ( Figures 7a-7c ) can be moved. 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 pushed back out of the needle guard position, as described below.

[0065] The tip holder 1 has a projection 1a that extends radially outwards, the projection 1a engaging in a slot-shaped recess of the needle guard sleeve 3, which is arranged between the housing 2 and the syringe holder 1. In the initial position of the needle guard sleeve 3 ( Figures 2a-2c ) and / or in the needle guard position of the needle guard sleeve 3 ( Figures 7a-7cThe needle guard 3, in particular the proximal end of the slotted recess, rests against the projection 1a, thus preventing movement of the needle guard 3 in the distal direction. A cam 1c, which is resiliently mounted on and formed by the syringe holder 1, can engage in this slotted recess, or alternatively in another recess of the needle guard 3. The cam 1c is designed such that when an attempt is made to move the needle guard 3 from its initial position to the actuated position, the cam 1c initially prevents movement of the needle guard 3. The cam 1c is then pushed out when the force applied to the needle guard 3 for retraction exceeds a certain threshold, thereby abruptly pushing the needle guard 3 back into the actuated position. This allows the needle 13a to be inserted abruptly into the injection site.To insert the needle 13a or to move the needle guard sleeve 3 into the actuated position, the distal end of the needle guard sleeve 3 is placed in the insertion point, whereby the housing 2 is then pressed towards the insertion point, whereby if the pressing force exceeds the threshold value mentioned above, the housing 2 is abruptly moved towards the insertion point and the needle guard sleeve 3 is moved relative to the housing 2 into the actuated position.

[0066] The housing 2 has an annular retaining section or ring section 2b, which in particular surrounds and abuts the distal end of the syringe holder 1, thereby holding the at least one shoulder 1b in engagement with the tapered region of the syringe body. Furthermore, the housing 2 has a translational stop in the region of the retaining section 2b in the form of a retaining shoulder 2e, which prevents the syringe holder 1 from being displaced distally relative to the housing 2 when the syringe holder 1 abuts the retaining shoulder 2e. This also applies advantageously to the described variants.

[0067] The autoinjector further comprises a sleeve-shaped drive element 7, which forms an inwardly projecting shoulder at its distal end. A first spring 9, which can also be referred to as a discharge spring, is supported against this shoulder. The first spring 9 is arranged within the sleeve-shaped drive element 7. The second spring 9 is a helical spring acting as a compression spring. In the initial or delivery state of the autoinjector, it is pre-tensioned with sufficient energy to discharge the product contained in the product container 13, particularly by completely displacing the drive element 7 through a discharge stroke HA. In the delivery state of the device, there is a gap between the piston 13b and the distal end of the drive element 7, so that the drive element 7 only comes into contact with the piston 13b during the execution of the discharge stroke HA and moves it in the discharge direction.

[0068] The first spring 9 is supported at its proximal end by a retaining element 6, which in this example has two arms 6c, each arm 6c having a first engagement element 6a and a second engagement element 6b. The first engagement element 6a points radially towards the longitudinal axis L, while the second engagement element 6b points 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 element 7 relative to the retaining element 6 in the distal direction or in the discharge direction. This holds the first spring 9 in its tensioned state. The retaining element 6 has a guide pin 6d that is inserted through the proximal end of the first spring 9 into the core of the spring 9. The guide pin 6d prevents the first spring 9 from buckling laterally during and at the end of the discharge stroke HA of the drive element 7.

[0069] The autoinjector has a switching module 8, 15, which includes a switching sleeve 15 and a locking sleeve 8 surrounded by the switching sleeve 15. In the delivered 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.

[0070] The switching sleeve 15 is connected to, or at least abuts, the proximal end 3a of the needle guard 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, is supported at its distal end against the switching sleeve 15. A portion of the switching sleeve 15 is thus located between the needle guard sleeve 3 and the distal end of the second spring 10. The second spring 10 is a compression spring and a helical spring made of metal. The second spring 10 is supported at its proximal end against a signal element 11, in particular against a projection 11c, which engages axially displaceably and rotationally fixedly in the housing 2 and which extends through a slot-shaped groove 5b of the mechanical holder 5. The second spring 10 thus also surrounds the mechanism holder 4 at least partially, preferably completely.

[0071] 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 projects radially away from the longitudinal axis L. The locking element 8a is resiliently mounted on an arm formed by the locking sleeve 8. By moving the switching sleeve 15 in the proximal direction, the locking sleeve 8 is moved along in the proximal direction via the engagement of the locking element 8a.

[0072] By moving the needle guard sleeve 3 into the actuated position, the switching sleeve 15 is also moved along by the actuating stroke HB, thereby tensioning the second spring 10. If the needle guard sleeve 3 is not fully moved into the actuated position, the second spring 10 can move the switching sleeve 15 and the needle guard sleeve 3 back to their initial positions, whereby the locking sleeve 8 is also moved along with the switching sleeve 15 via the engagement of the locking element 8a.

[0073] The signal element 11, which is particularly sleeve-shaped, is in an axially fixed engagement with the drive element 7 in the delivery state or before the product discharge is triggered. The signal element 11 has a first engagement element 11a, which engages in a recess 7b of the drive element 7, and a second engagement element 11b. The first engagement element 11a and the second engagement element 11b are resiliently arranged at the end of an arm 11d. The signal element 11 has two such arms 11d, each with a first engagement element 11a and a second engagement element 11b. The first engagement element 11a points radially towards the longitudinal axis L, while the second engagement element 11b points radially away from the longitudinal axis L. In the delivery state, the first engagement element 11a is held in the axially fixed engagement with the drive element 7 by the inner circumference of the locking sleeve 8. The second engagement element 11b rests against the inner circumference of the switching sleeve 8.The closure cap 12 has a signal stop 12b, against which the signal element 11 can strike to generate a signal and preferably against which the signal element 11 rests in the delivery state of the device.

[0074] To administer the product from the product container 13, the pull-off cap 4 is removed from the autoinjector along with the rigid needle shield 14. The distal end of the needle shield 3 is placed at the injection site of a patient, with the housing 2 being moved towards the injection site. This causes the needle shield 3 to move 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, which moves the switching sleeve 15 along with 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 moving the locking sleeve 8 by the actuation stroke HB along the longitudinal axis L, as shown in the Figures 3a-3cThis is illustrated. The first engagement element 6a is thereby moved out of engagement with the drive member 7 in 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 drive member 7 for movement by the discharge stroke HA in the discharge direction.

[0075] Since the axially fixed coupling between the drive element 7 and the retaining element 6 is now released, the retaining 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, whereby the retaining 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) carries the locking sleeve 8 along, causing it to strike a start signal stop 5a formed by the mechanical holder 5, thereby emitting an acoustic and / or tactile signal that indicates to the user of the device that the product dispensing has started. The displacement of the locking sleeve 8 by the actuating stroke HB releases the locking element 8a for movement transversely and along the longitudinal axis L, since the mechanical holder 5 has a recess 5d that permits such movement of the locking element 8a when the locking sleeve 8 has been displaced by the actuating stroke HB or when the needle guard sleeve 3 is in its actuated position.

[0076] Since the signal element 11 is still axially fixed to the drive element 7, it is carried along by a first partial stroke HS of the discharge stroke HA in the discharge direction, whereby the signal element 11 is moved approximately by the first partial stroke HS away from the signal stop 12b, as is best seen from Figure 4c This is evident. At the end of the first partial stroke HS, during which the first and second engagement elements 11a, 11b are moved relative to the locking sleeve 8, the first engagement element 11a is disengaged from the drive element 7, while simultaneously the second engagement element 11b is moved into the second recess 8c of the locking sleeve 8 in a movement transverse to the longitudinal axis L and radially away from the longitudinal axis L. This prevents the signal element 11 from moving in the proximal direction relative to the housing 2 or the locking sleeve 8. The second engagement element 11b is held in engagement with the recess 8c by the outer circumference of the drive element 7 ( Figure 4a ), when the thrust member 7 is moved by its second partial stroke of the discharge stroke HA. The outer circumferential surface of the thrust member 7 holds the second engagement element 6b in engagement with the first recess 8b of the locking sleeve 8, as best as possible from Figure 4b This is recognizable. At the end of the discharge stroke HA, the drive element 7 releases the second engagement element 11b from engagement with the locking sleeve 8, thereby moving the second engagement element 11b from engagement with the recess 8c, in particular towards the longitudinal axis L, so that the second spring 10 accelerates the signal element 11 against the discharge direction, i.e. in the proximal direction, so that when the signal element 11 hits the signal stop 12b an acoustic and / or tactile signal is generated.

[0077] How best to Figure 5bAs can be seen, the engagement of the second engagement element 6b in the first recess 8b remains in place, thereby preventing movement of the locking sleeve 8 in the distal direction relative to the housing 2.

[0078] By removing the autoinjector from the injection site, the second spring 10 can move the switching sleeve 15 and the needle guard sleeve 3 from the actuated position to the needle guard position by the needle guard stroke HN, thereby disengaging the locking element 8a from the recess 15a and causing the switching sleeve 15 to move distally relative to the locking sleeve 8. When the needle guard sleeve 3 is in its needle guard position, the locking element 8a snaps into the switching sleeve 15, preventing the needle guard sleeve 3 from being pushed back into its actuated position. Any attempt to push the needle guard sleeve 3 back from the needle guard position to the actuated position causes the switching element 15 to abut the locking element 8a, which prevents movement of the needle guard sleeve 3 into the actuated position. The locking sleeve 8 is axially supported against the start signal stop 5a of the mechanical holder 5 for this purpose.

[0079] The following shows various designs of a syringe holder that can be used with an autoinjector, preferably but not necessarily an autoinjector of the type described above.

[0080] The syringe module from the Figures 8a to 8d The first shell body or sleeve body 103 has a lateral opening and at least one, i.e., in the example shown, two shoulder-shaped engagement elements 1b, which project inwards, i.e., towards the longitudinal axis of the sleeve body 103. Furthermore, the sleeve body 103 has a distally directed translational counter-stop 1k. For the assembly of the syringe 13 ( Figure 8b ) this is inserted laterally, i.e. with a movement transverse to the longitudinal axis into the sleeve body 103, whereby the at least one engagement element 1b is inserted into the gap between the needle guard cap 14 and the tapered section of the syringe body of the syringe 13.

[0081] The syringe module further comprises a second shell body, in particular sleeve body 104 ( Figure 8c ), which is open at its proximal end and has at least one, i.e., in the example shown, two translation stops 1 m at its distal end, projecting radially inwards. As in the embodiment from the Figures 1 to 7c The sleeve body 104 has at least one cam 1c, namely two cams 1c, and at least one projection 1a, namely two projections 1a. The cam 1c is resiliently arranged on the sleeve body 104 via an arm.

[0082] The unit consisting of syringe 13, needle guard 14 and the first sleeve body 103 is advanced along the longitudinal axis with the needle guard 14 leading the way via the proximal end ( Figure 8b ) into the second shell body 104 ( Figure 8c) inserted, wherein the translation counter-stop 1k abuts the translation stop 1m when the unit 13, 14, 103 is fully inserted into the sleeve body 104 ( Figure 8d ). The in Figure 8d The unit shown is then moved within the housing 2 of the autoinjector for assembly such that the retaining section 2b, in particular the annular retaining section or ring section, bears against at least the first sleeve body 103, at least in the region of the engagement element 1b, so that the engagement element 1b is held in engagement with the tapered section of the syringe body. Furthermore, the retaining section 2b can also bear against the second sleeve body 104, in particular in the region where the at least one translational stop 1m is formed, in order to hold the translational stop 1m in engagement with the translational counter-stop 1k.

[0083] In the Figures 9a-9cIn the embodiment shown, the syringe module, in particular the syringe holder, has a first shell body 101 and a second

[0084] Shell bodies 102, each formed as a half-shell. Each of the shell bodies 101, 102 has a cam 1c and a projection 1a in the manner described herein.

[0085] The first shell body 101 and the second shell body 102 are in the in Figure 9a The view shown shows several predetermined breaking points connected in one piece, with the first and second shell bodies 101, 102 occupying an insertion position relative to each other. The proximal end of the Figure 9a The syringe 13, with the needle guard 14 leading, is inserted distally into the body 101, 102 shown ( Figure 9b) until the gap between the tapered section and the needle guard cap 14 is positioned along the longitudinal axis L in the same position as the at least one engagement element 1b. In the example shown, each of the first and second shell bodies 101, 102 has an engagement element 1b. By pressing the first and second shell bodies 101, 102 against each other transversely to the longitudinal axis L, the predetermined breaking points are broken, whereby the first and second shell bodies 101, 102 snap together positively and the engagement elements 1b are moved into the gap. As already described, the area of ​​the first and second shell bodies 101, 102 on which the engagement element 1b is formed can be enclosed by the retaining section 2b of the housing 2, thereby holding the engagement elements 1b in engagement with the tapered area of ​​the syringe body.Particularly preferentially, the shell bodies 101, 102 can move into the insertion position transversely to the longitudinal axis against the elastic force of the arms which carry the projection 1a and / or the cam 1c when the syringe 13 is inserted. As described, the engagement elements 1b can then be brought into engagement with the tapered section of the syringe body 13 by the retaining section 2b of the housing 2 and held there. Alternatively or additionally, the first shell body 101 and the second shell body 102 can be in the closed position ( Figure 9c ), in which the intervention elements 1b engage in the gap and lock together.

[0086] In the Figures 10a-10d In the embodiment shown, the syringe holder 1 has a first shell body 101 and a second shell body 102, each formed as a half-shell and in particular designed identically so that tooling costs can be saved.

[0087] Each of the first and second shell bodies 101, 102 has a cam 1c and a projection 1a as described. Furthermore, each of the first and second shell bodies 101, 102 has an engagement element 1b at its distal end.

[0088] Each of the shell bodies 101, 102 has a hinge pin 1e and a hinge pin receptacle 1f ( Figure 10a ), wherein the hinge pin 1e of one shell body 101, 102 is inserted into the hinge pin receptacle 1f of the other shell body 102, 101 ( Figure 10b ), so that the first and second half-shells 101, 102 are pivotable relative to each other about the pivot axis of the pivot joint 1e, 1f, which is formed from the hinge pins 1e and the hinge pin receptacles 1f, namely between an insertion position ( Figure 10c ) and a closing position ( Figure 10dThe syringe 13, together with the needle guard 14, is inserted via the proximal end of the syringe body 1. The needle guard 14 is moved past the engagement element 1b, pivoting the first cup body 101 and the second cup body 102 relative to each other when the gap between the needle guard 14 and the tapered section of the syringe body is in the same position as the engagement elements 1b with respect to the longitudinal axis L. This causes the engagement elements 1b to engage in the aforementioned gap. As described, the engagement elements 1b can be held in engagement with the tapered section of the syringe body by the retaining section 2b of the housing 2. Alternatively or additionally, the first cup body 101 and the second cup body 102 can be held in the closed position ( Figure 10d ), in which the intervention elements 1b engage in the gap and lock together.

[0089] In the Figures 11a to 11cAn embodiment of the syringe holder 1 is shown, comprising a first sleeve body 103 and two pivot arms 1h. The projection 1a is formed on the sleeve body 103. The sleeve body 103 forms two hinge pin receptacles 1g for each of the pivot arms 1h, in each of which a hinge pin 1i of the pivot lever 1h is arranged. Each pivot lever 1h forms two hinge pins 1i that are latched to the hinge pin receptacle. The pivot pin 1i is rotatable relative to the pivot pin receptacle 1g and can slide on the hinge pin receptacle 1g. The pivot lever 1h has a lever section that points distally, with the engagement element 1b formed by the pivot lever 1h at the distal end of this lever section for engaging the gap between the needle guard cap 14 and the tapered section of the syringe body.

[0090] The pivot lever 1h shown in the example is two-armed, with the lever section that projects from the pivot joint 1g, 1i in the opposite direction to the arm that forms the engagement member 1b forming the cam 1c.

[0091] The syringe 13, with the needle guard 14 leading, is inserted into the sleeve body 103 via the proximal end of the sleeve body 103, whereby the needle guard 14 is moved past the engagement elements 1b until the gap between the tapered section of the syringe body and the needle guard 14 is in the same position as the engagement elements 1b with respect to the longitudinal axis. By pivoting the pivot lever 1h, the engagement elements 1b are pivoted into the gap or towards the longitudinal axis. The in Figure 11cThe unit shown is then arranged in the housing 2 of the autoinjector such that the retaining section 2b fixes the pivot lever 1h in such a way that the engagement elements 1b are held in engagement with the tapered section of the syringe body. The arm on which the cam 1c is formed is elastically deformable with respect to the arm on which the engagement element 1b is formed, thereby enabling the cam 1c to perform its function with respect to the needle guard sleeve 3. In particular, the cam 1a serves as a stop for the needle guard sleeve 3, with the needle guard sleeve 3 bearing against the cam 1a when the needle guard sleeve is in its initial position and / or in its needle guard position.

[0092] In the Figures 12a-12dIn the fifth embodiment shown, the syringe module, in particular the syringe holder 1, has a sleeve body 103. The sleeve body 103 has, in particular, two cams 1c and, in particular, two projections 1a as shown herein.

[0093] In this variant, the at least one engagement element can be resiliently formed as a shoulder 1b, in particular on an elastic arm 1h on the syringe holder, wherein the syringe 13 is inserted into the syringe holder, which is preferably sleeve-shaped, via its proximal end with the needle first, wherein the needle guard 14 deflects the at least one engagement element 1b outwards transversely to the longitudinal axis, i.e. away from the longitudinal axis, wherein, when the needle guard 14 has been completely moved past the at least one engagement element 1b, the at least one engagement element 1b snaps into the gap between the tapered region of the syringe 13 and the proximal end of the needle guard 14. Figure 12c The unit shown is then arranged in the housing 2 of the autoinjector such that the retaining section 2b fixes the arm 1h in such a way that the engagement elements 1b are held in force- or form-locking engagement with the tapered section of the syringe body 13 and can no longer spring out of this engagement.

[0094] In the Figures 8e, 9d , 10e, 11d , 12d Longitudinal sections of the five embodiments in their delivered state are shown, and for embodiments two to five, sections are shown in a position with the syringe partially and fully inserted, corresponding to each assembly step of the syringe assembly in the autoinjector. When the syringe is fully inserted, the at least one snap 4b, which has the pull-off cap 4, engages in the gap between the syringe body 13, in particular its tapered region, and the proximal end of the rigid needle shield 14 ( Figure 2a, 2b ).

[0095] The at least one engagement element 1b, together with the syringe holder 1, is axially pushed into the area of ​​the holding section 2b by an assembly stroke HM, which is performed particularly as the final assembly step, so that a force-fit or form-fit connection is created. This prevents the at least one engagement element 1b from moving out of engagement with the tapered section of the syringe body 13 transversely to the longitudinal axis, in particular away from or outwards from the longitudinal axis L. Furthermore, this assembly stroke moves the pull-off cap 4 into its distal position, which it occupies in the delivered state of the autoinjector. The pull-off cap 4 is moved through the syringe holder 1 by means of at least one snap hook 4a, which is supported on the syringe holder 1. Reference symbol list 1 syringe holder 8 Locking sleeve 1a Recess / retaining element 8a locking element 1b Shoulder / articular limb 8b first extraction 1c cam 8c second recess 1e hinge pin 1f hinge pin receptacle 9 first spring / discharge spring 10 second spring / needle guard spring 1g hinge pin receptacle 1i hinge pin 1h Swivel lever / arm 11 Signal element 1k Translation counter-offset 11a first intervention element 1m Translation attack 11b second intervention element 11c Removal 2 Housing 11d arm 2a Exclusion 2b Ring section / Stop section 12 Cap 2c Actuation stop 12a Locking element 2e Holding shoulder 12b Signal attack 3 Needle guard sleeve 13 Product container / syringe 3a proximal end 13a needle 3b Snap geometry 13b Pistons 4 Pull-off cap 14 rigid needle shield / 4a Snap hook Needle guard cap 4b Bargain 15 Switching sleeve 5 Mechanism holder 15a Exclusion 5a Starting signal stop 5b Nut 101 first shell body / half-shell 5c Retaining spring section 102 second shell body / half-shell 5d in-depth 103 first shell body / sleeve body 6 retaining element 104 second shell body / sleeve body 6a first intervention element 6b second intervention element HA Excavation 6c arm HB Actuating stroke 6d guide pen HS Signal stroke / first partial stroke HK Start signal hub 7 drive element HN Needle guard lift 7a first extraction HM Assembly hub 7b second recess L Longitudinal axis

Claims

1. Autoinjector having a longitudinal axis (L), for dispensing a liquid product, comprising: a) a housing (2) and a product container (13) of a syringe arranged in the housing (2), at the distal end of which product container an injection needle (13a) is fixedly arranged and covered by a needle shield (14), and which product container has a movable plunger (13b), the plunger (13b) being movable in a dispensing direction for dispensing the product contained in the product container (13), b) a propulsion element (7) which acts on the plunger (13b) when the product is being dispensed, and a first spring (9) which acts on the propulsion element (7), the first spring (9) being pre-tensioned to such an extent that it can dispense the product out of the product container (13b) by moving the propulsion element (7) by one dispensing stroke (HA) and by moving the plunger (13b), c) a syringe holder (1) for receiving the product container (13) and for securing the product container (13) against a movement along the longitudinal axis (L) in a distal direction, the syringe holder having an inwardly projecting shoulder (1b) formed on the syringe holder (1), d) a holder which presses the product container (13) at its proximal end into an engagement with the shoulder (1b), and e) a holding portion (2b) of the housing (2), which holding portion surrounds a distal end of the syringe holder (1) in an annular manner, as a result of which the shoulder (1b) is held in engagement with a tapered portion of the product container (13) distal to a cylindrical syringe body portion, f) the syringe holder (1) being axially fixed to the housing (2) and the autoinjector having a needle protection sheath (3) which is movable 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 dispensing of the product, characterized in that g) the shoulder (1b) is a shoulder (1b) resiliently formed on the syringe holder (1), which shoulder, when the product container (13) is inserted into the syringe holder (1), can be deflected by the needle shield (14), and can snap into a gap between the tapered region of the product container (13) and a proximal end of the needle shield (14).

2. Autoinjector according to claim 1, characterized in that the holder is formed by a holding spring portion (5c) of a mechanism holder (5) which is arranged immovably along the longitudinal axis (L) in the housing (2).

3. Autoinjector according to either of the preceding claims, characterized in that the shoulder (1b) can be deflected outward by the needle shield (14) transversely to the longitudinal axis (L) when the product container (13) is inserted into the syringe holder (1).

4. Autoinjector according to any of the preceding claims, characterized in that the holding portion (2b) rests against an outer surface of the syringe holder (1) and prevents the shoulder (1b) from moving away from the longitudinal axis transversely to the longitudinal axis (L).

5. Autoinjector according to claim 2, characterized in that the mechanism holder (5) is snap-fit with the housing (2).

6. Autoinjector according to any of the preceding claims, characterized by a pull-off cap (4) for removing the needle shield (14) from the product container (13).

7. Autoinjector according to any of the preceding claims, characterized in that the housing (2), in the region of the holding portion (2b), has a translation stop in the form of a holding shoulder (2e), which prevents the syringe holder (1) from being movable relative to the housing (2) in the distal direction when the syringe holder (1) rests against the holding shoulder (2e).

8. Method for assembling an autoinjector having a longitudinal axis (L) for dispensing a liquid product, comprising: a) a housing (2) and a product container (13) of a syringe arranged in the housing (2), at the distal end of which product container an injection needle (13a) is fixedly arranged and covered by a needle shield (14), and which product container has a movable plunger (13b), the plunger (13b) being movable in a dispensing direction for dispensing the product contained in the product container (13), b) a propulsion element (7) which acts on the plunger (13b) when the product is being dispensed, and a first spring (9) which acts on the propulsion element (7), the first spring (9) being pre-tensioned to such an extent that it can dispense the product out of the product container (13b) by moving the propulsion element (7) by one dispensing stroke (HA) and by moving the plunger (13b), c) a syringe holder (1) for receiving the product container (13) and for securing the product container (13) against a movement along the longitudinal axis (L) in a distal direction, the syringe holder having an inwardly projecting shoulder (1b) formed on the syringe holder (1), d) a holder which presses the product container (13) at its proximal end into an engagement with the shoulder (1b), and e) a holding portion (2b) of the housing (2), which holding portion surrounds a distal end of the syringe holder (1) in an annular manner, as a result of which the shoulder (1b) is held in engagement with a tapered portion of the product container (13) distal to a cylindrical syringe body portion, f) the syringe holder (1) being axially fixed to the housing (2) and the autoinjector having a needle protection sheath (3) which is movable 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 dispensing of the product, characterized by the steps of g) deflecting the shoulder (1b) resiliently formed on the syringe holder (1) by the needle shield (14) when the product container (13) is inserted into the syringe holder (1), and snapping the shoulder (1b) resiliently formed on the syringe holder (1) into a gap between the tapered region of the product container (13) and a proximal end of the needle shield (14).