CH712891A2 - Injection device with a cap for removing a needle cap from a product container and method for mounting an injection device. - Google Patents

Abstract

The invention relates to an injection device with a cap (2, 2 ', 2 ", 2'") for removing a needle protection cap (5, 5 ', 5 ", 5'") from a product container (3, 3 '). , 3'', 3''') and a method for mounting an injection device, wherein the cap (2, 2 ', 2 ", 2'") has an engagement element (2c, 2c ', 2c ", 2c' '') To remove the needle cap (5, 5 ', 5 ", 5'") from the product container when removing the cap (2, 2 ', 2 ", 2' '') from the injection device (3, 3 ', 3 ", 3' ''), and wherein, the engagement element (2c, 2c ', 2c", 2c' ") is deformable such that the engagement element (2c, 2c ' 2c ", 2c" ") from a spaced apart position in which the engagement element (2c, 2c ', 2c", 2c' ") is separated from the needle shield (5, 5 ', 5", 5 ") ') Is radially spaced, in an engaged position, in which the engagement element (2c, 2c', 2c ", 2c '") is engaged with the needle guard cap (5, 5 ', 5 ", 5' '') is, is feasible, wherein the engagement element (2c, 2c ', 2c' ', 2c' '') upon removal of the cap (2, 2 ', 2 '', 2''') is deformed.

Description

Description: The invention relates to an injection device for administering a liquid product, in particular a medicament. The invention further relates to a method for assembling and / or preparing an injection device for the administration of a product.

The term "medicament" here encompasses any flowable medical formulation which is suitable for controlled administration through an agent such as a cannula or hollow needle, for example comprising a liquid, a solution, a gel, or a fine suspension, which one or contains several medicinal substances. Medicament can be a composition with a single active substance or a premixed or co-formulated composition with several active substances from a single container, medicament comprises medicaments such as peptides (eg insulins, medicines containing insulin, GLP-1 containing and derived or analogous preparations), proteins and hormones, biologically obtained or active substances, active substances based on hormones or genes, nutritional formulations, enzymes and other substances both in solid (suspended) or liquid form but also polysaccharides, vaccines, DNA or RNA or oligonucleotides, antibodies or parts of antibodies and suitable base, auxiliary and carrier substances.

Injection devices are known from the prior art, in which a pre-filled syringe is arranged. The pre-filled syringe has an injection needle which is permanently connected to the pre-filled syringe and via which a medicament contained in the pre-filled syringe can be dispensed. In order to keep the injection needle and the medication of the pre-filled syringe sterile, the injection needle is enclosed by a needle protection cap attached to the pre-filled syringe and sealed sterile with respect to the environment. Such needle caps can e.g. be designed as a so-called soft needle shield (SNS) or as a rigid needle shield (RNS). A soft needle shield (SNS) consists of an elastomeric part that surrounds the injection needle. A rigid needle shield (RNS) has several parts, in particular an elastomeric cap-shaped part and one made of a solid, i.e. Non-elastomeric plastic manufactured sleeve-shaped part, which receives the elastomeric part and is essentially inextricably linked.

When handling the pre-filled syringe, there is a risk that the sterility of the injection needle and the medication is endangered by the force acting on the needle protection cap. This can occur in particular during the assembly process of the injection device, in particular when the pre-filled syringe is inserted into the syringe holder of the injection device provided for this purpose. The insertion of the pre-filled syringe into the injection device is therefore a step from the point of view of the sterility of the injection needle and the medicament, which requires special attention. From WO 2010/136 076 A1, US 9 339 610 B2, WO 2015/144 871 A1 and US 2016/0243 315 A1 it is known that when a cap-shaped pull-off element, which is also referred to as a cap, is removed at the distal end End of the injection device is attached and the distal end of the injection device closes, the needle protection cap attached to the pre-filled syringe also removed, ie when removing the cap from the pre-filled syringe. The needle protection cap remains in the cap. For this purpose, the cap has engaging members which are brought into engagement with the needle protection cap when the cap is removed. When the pull-off movement of the pull-off element continues, the engagement members take the needle protection cap with them, as a result of which it is pulled off the pre-filled syringe. In order to ensure a safe removal of the needle protection cap by removing the cap, it is known from the prior art that the engagement members connected to the cap come into engagement with the needle protection cap.

It is an object of the invention to provide an injection device and a method for assembling and / or preparing an injection device for the administration of a product, or the simple insertion of the product container into the injection device and / or a safe removal of the needle cap allowed by the product container without inadvertently endangering the sterility of the injection needle and the medication.

The object is achieved with the injection device according to claim 1 and the method according to claim 9. Advantageous further developments result from the dependent claims, the description and the figures.

The invention relates to a device for administering a product, namely an injection device. The injection device can be designed as a so-called auto-injector, which has a mechanism that automatically dispenses the product, e.g. caused by an energy store, in particular a spring, and optionally an automatic insertion and / or withdrawal of the injection needle. In the case of an auto injector, the force for dispensing the product through the energy store, e.g. the spring provided. The injection device can alternatively be designed as a manual injection device, i.e. the force for the release of the product by muscle power, e.g. done by the user himself. The injection device - regardless of whether it is an auto-injector or a manual injection device - can have a needle protection sleeve which, after the injection has been made, stands distally over the distal end of the injection needle or is displaced into this position relative to the housing in order to inadvertently access the Prevent injection needle and thereby reduce the risk of injury. In the case of an auto-injector, the needle protection sleeve can also serve, for example, as a trigger element for triggering the product distribution, the needle protection sleeve being displaced in the proximal direction relative to the housing for this purpose. Alternatively, the triggering of the auto-injector can be achieved by actuating a trigger button on the auto-injector, the needle protection sleeve serving as a privacy screen before the auto-injector is used.

CH 712 891 A2 The injection device has a product container with an injection needle, e.g. a pre-filled syringe known from the prior art or a syringe in general. The product container can e.g. have hollow cylindrical product container section which slidably supports a piston. The piston can form a sealing gap with the inner circumference of the product container section and thus form a sterile barrier. The piston can e.g. are displaced in the distal direction by means of a piston rod of the injection device in order to deliver product from the product container via the injection needle. The injection needle can preferably be non-detachably formed on the product container. For example, the product container can have a holding section, in particular a needle holding section, which is arranged distally of the product container section and is non-detachably connected to the injection needle and thus surrounds, for example, a proximal part of the injection needle. The injection needle can thus protrude from the holding section in the distal direction. The holding section can, for example, have a smaller outside diameter than the product container section. The product container section can taper at its distal end towards the holding section.

The term "distal" as used herein refers to the direction in which the tip of the hypodermic needle is pointing. The term "proximal" as used herein refers to the direction opposite to the distal direction.

On the product container, for example on the holding section, there is a needle protection cap, e.g. a known from the prior art soft needle shield (SNS) or rigid needle shield (RNS), attached, in particular releasably attached. The needle protection cap can e.g. be frictionally or positively or combined frictionally and positively on the holding portion. The needle protection cap encloses the injection needle and seals it sterile in relation to the environment. A soft needle shield (SNS) comprises or consists of an elastomeric part, for example formed on a rubber or rubber base, which surrounds the needle. The soft needle shield (SNS) has a soft, e.g. surface formed from a rubber or rubber-like material. A rigid needle shield (RNS) usually has several parts, in particular an elastomeric cap-shaped inner part and one made of a solid, i.e. Non-elastomeric plastic made sleeve-shaped or cap-shaped outer part, which receives the elastomeric part and is essentially non-detachably connected. The outer sleeve-shaped or cap-shaped part surrounds the inner cap-shaped part and is permanently connected to the inner cap, for example, so that the outer and inner cap form a unit. The inner part can be made of a harder plastic than the inner part. The outer part can be made of polyethylene, polystyrene, polypropylene or another suitable plastic, for example. The inner part can for example be made of rubber or caoutchouc or another suitable material.

At the distal end of the injection device or housing, such as e.g. of a receiving housing of the injection device, a cap, which can also be referred to as a closure cap or pull-off cap or can be designed, can be attached and close the distal end of the housing or of the receiving housing. The injection device can be a housing, e.g. comprise a receiving housing of the injection device for receiving the product container, the product container having a firmly connected injection needle and the needle protective cap being detachably arranged on the product container. The needle protection cap encloses the injection needle and seals the injection needle sterile from the environment. The cap can e.g. be frictionally and / or positively connected to the housing or receiving housing, e.g. be snapped. The cap can e.g. during removal from the injection device or housing with an axial movement or a combined axial-rotary movement from the injection device, such as. B, the housing or receiving housing, be removable.

The injection device can further comprise a product container holder, which is firmly connected to the housing of the injection device, in particular axially and rotationally. The product container holder can serve to hold the product container, it being possible for the product container to be held firmly, in particular axially and preferably in a rotational test, in the product container holder. Alternatively, the housing and the product container holder can be formed in one piece. Alternatively, the product container holder can be arranged to be axially movable and / or rotatable relative to the housing.

The cap, which is releasably provided on the distal end of the housing of the injection device, comprises one or more engagement elements in order to effect the removal of the needle protection cap from the product container when the cap is removed from the injection device. The cap, which is coupled to the engagement element, can be connectable to the needle protection cap via the engagement element in such a way that the removal of the cap from the injection device brings about the removal of the needle protection cap from the product container. In particular, at least some or all of the movement of the cap in the distal direction can be transmitted to the engaging element, i.e. the engaging element is carried along by the cap, so that the engaging element pulls the needle protection cap off the product container, in particular the holding section.

The engagement element is deformable in such a way that the engagement element can be reached from a spaced position, in which the engagement element is radially spaced from the needle protection cap, into an engagement position, in which the engagement element is engaged with the needle protection cap, the engagement element during Removing the cap is deformed. Furthermore, the engaging element is designed such that when the injection device is assembled, in particular when the product container is inserted into the housing or into the product container holder, no or very few forces, in particular no or very few forces exerted by the engaging element act on the needle protection cap. This prevents the needle protection cap from being moved relative to the product container while the product container is being inserted. This reduces the risk that the sterility of the injection needle and the

CH 712 891 A2

Drug suffers. With this arrangement it can further be achieved that no or very few forces exerted by the engagement element act on the needle protection cap during storage of the injection device.

The engaging element can e.g. in the delivery state of the injection device with respect to the needle cap in the spaced-apart position. In the engagement position, the engagement element is arranged with respect to the needle protection cap in such a way that movement of the cap in the distal direction causes the needle protection cap to be carried along and the needle protection cap is thus removed from the product container. In the engagement position of the engagement element, the engagement element engages on or in the needle protection cap. The engagement element can engage on or in a lateral surface or on or in an edge or on or in a distal end surface or on or in a proximal end surface of the needle protection cap. The engagement element can particularly preferably be hook-shaped. The hook-shaped engagement element can have a short and a long leg. Alternatively, the engagement element can have a different configuration, the engagement element being radially spaced from the needle protection cap in the spaced-apart position of the engagement element and the engagement element being in engagement with the needle protection cap in the engagement position of the engagement element, the engagement element being deformed when the cap is removed.

In the spaced position of the engagement element, the engagement element can be undeformed, deformed or deformed radially outwards. In the engagement position of the engagement element, the engagement element can be undeformed, deformed or deformed radially inwards. The engagement element is plastically and / or elastically deformable.

[0017] An irreversible deformation is referred to as a plastic deformation. The deformation of a material is plastic if the material does not return to its original shape on its own. The material retains its shape after being subjected to a force or load. A reversible deformation is referred to as an elastic deformation. A material can then return to its original state after the force or load has been exerted on it.

The engaging element is preferably made of metal, in particular steel, particularly preferably of stainless steel, in particular of stainless spring steel. The engagement element is formed from a material which has a flexural strength which permits plastic and / or elastic deformation. The engaging element is particularly preferably designed such that it is plastically and / or elastically deformed in the spaced-apart position of the engaging element and is plastically and / or elastically undeformed in the engaged position or that it is plastically and / or elastically undeformed in the spaced-apart position of the engaging element and is plastically and / or elastically deformed in the engagement position.

Particularly preferably, the engaging element can be plastically and / or elastically deformed radially outward in the spaced position of the engaging element or alternatively formed plastically and / or elastically undeformed. Particularly preferably, the engaging element in the engaging position of the engaging element can be plastically and / or elastically undeformed or, alternatively, plastically and / or elastically deformed radially inward. In the spaced-apart position of the engaging element, the long leg of the hook-shaped engaging element can particularly preferably be plastically and / or elastically deformed radially outwards or alternatively plastically and / or elastically undeformed and the short leg of the hook-shaped engaging element protrudes radially inwards. In the engaging position of the engaging element, the long leg of the hook-shaped engaging element can particularly preferably be plastically and / or elastically deformed or alternatively plastically and / or elastically deformed, in particular deformed radially inward, and the short leg of the hook-shaped engaging element protrudes radially inward, whereby the short leg of the engagement element engages with the outer surface of the needle cap, in particular is always engaged. The outer surface of the needle protection cap can have one or more openings or one or more fastening means into which the engagement element can engage or drill into the engagement position of the engagement element. Alternatively, the needle protection cap has no opening or no fastening means, the engagement element being able to engage or drill into the outer surface of the needle protection cap in the engagement position of the engagement element.

Alternatively or additionally, the engagement element can have a fastening element which, in the engagement position of the engagement element, can have a fixed, in particular an axially and radially fixed connection with the needle protection cap. The fastening element of the engagement element can form a firm connection with the lateral surface or with an edge of the needle protection cap. One or more openings or one or more fastening means can be provided on the lateral surface or on the edge of the needle protection cap, wherein the fastening element of the engagement element can establish a firm connection with the opening or the fastening means of the needle protection cap. Alternatively, the needle protection cap has no opening or no fastening means, the fastening element of the engagement element being able to engage or drill into the lateral surface or into the edge of the needle protection cap.

Furthermore, the cap can have a sleeve, wherein the sleeve can at least partially include the engagement element. The sleeve can preferably have an inner sleeve and an outer sleeve. The engaging element can be axially movable with the sleeve or preferably axially fixed. The engaging element can preferably be axially movable with the inner sleeve or preferably axially fixed. The sleeve can preferably be made of plastic. Alternatively, the sleeve can be made of metal. The sleeve can e.g. be frictionally and / or positively connected to the housing of the injection device, e.g. be snapped. For this, e.g. an engagement member can be provided on the outer sleeve of the sleeve, which can be releasably engaged in a counter-engagement member attached to the housing. The sleeve can e.g. during removal of the cap from the injection device or the housing

CH 712 891 A2 an axial movement or a combined axial-rotary movement from the injection device, such as e.g. be removable from the housing.

The cap may further comprise a sleeve-shaped remover element, wherein the engagement element can be provided on the remover element. The remover element can be sleeve-shaped, wherein the engagement element can be attached to a proximal end of the remover element. The remover element and the engagement element can be formed in one or two pieces. The remover element and the engagement element can preferably be formed from the same material. The remover element and the engagement element are particularly preferably formed from a stamped and bent part. The stamped and bent part is plastically and / or elastically deformable. The stamped and bent part is preferably formed from metal, in particular from steel, particularly preferably from stainless steel, in particular from stainless spring steel. The stamped and bent part is formed from a material which has a flexural strength which permits plastic and / or elastic deformation. The stamped and bent part can be bent into a sleeve shape. Alternatively, the remover element and the engagement element can be formed from different materials. The sleeve can surround the sleeve-shaped remover element, for example, preferably enclose it over its circumference. The remover element is preferably an element separate from the sleeve, but which is connected to the sleeve, e.g. can be connected displaceably or non-displaceably along the longitudinal axis L. The remover element can preferably have one or more projections which are latched into recesses provided on the sleeve in order to form an axially fixed connection between the sleeve and the remover element. The remover element can preferably be connected to the inner sleeve of the sleeve so as to be displaceable or non-displaceable, the recesses being provided on the inner sleeve.

Furthermore, one or more locking elements may be provided on the housing or on a housing firmly connected part, the locking element or locking elements holding or bringing the engagement element into engagement with the needle protection cap in the engagement position. The locking element can comprise a first and / or a second inclined surface, in particular a first and / or a second inwardly projecting inclined surface. The first and / or the second inclined surface of the locking element can have an inclination. The first and second inclined surfaces can be inclined to one another. The engagement element of the cap is coupled to the locking element of the housing in such a way that during the removal of the cap from the injection device, the engagement element is or can be moved relative to the needle protection cap and by means of this movement, in particular an axial movement or a combined axial-rotary movement the locking element of the housing is deformable or is deformed in such a way that the engaging element can or does come into engagement with the needle protection cap. In the engagement position of the engagement element, the engagement element is axially fixedly connected to the needle protection cap, the needle protection cap being carried along by the engagement element of the cap when the axial movement or the combined axial-rotational movement of the cap continues. In other words, the stroke that the cap performs in the distal direction when removed from the injection device relative to the housing along the longitudinal axis L includes a first partial stroke, during which the cap is movable or is moved relative to the needle protection cap, and a second partial stroke , during which the needle protection cap follows the movement of the cap or is carried along by the cap.

The invention also relates to a method for assembling an injection device and / or for preparing an injection device for the administration of a product. The injection device can e.g. is the injection device described herein.

The method comprises the step of providing a housing or a receiving housing, which e.g. Can be part of a housing of the injection device, for receiving a product container. The housing or the receiving housing can e.g. be sleeve-shaped and / or elongated.

The method further includes the step of providing a cap that can be releasably attached to a distal end of the housing. The cap can e.g. snapped with the housing. The cap includes one or more engaging elements to cause the needle cap to be removed from the product container when the cap is removed from the injection device.

The cap may further comprise a remover element, wherein the engagement element is arranged on the remover element. The remover element and the engagement element can be formed in one or two pieces. Furthermore, the cap can comprise a sleeve, the sleeve being able to surround the sleeve-shaped remover element, for example, preferably encompassing its circumference. The remover element is preferably an element separate from the sleeve, but which is connected to the sleeve, e.g. can be connected along the longitudinal axis L or preferably connected immovably. The engagement element and preferably the remover element are preferably formed from a different material than the sleeve. The sleeve is preferably made of plastic. The engagement element and the remover element are preferably formed from the same material.

The method further comprises providing the product container which has a firmly connected injection needle, a needle protection cap being releasably arranged on the product container, which cap encloses the injection needle and seals it sterile to the environment. The product container can e.g. a pre-filled syringe known from the prior art or in general a syringe. The product container can e.g. comprise hollow cylindrical product container section, wherein a piston is slidably arranged in the product container. The piston is used to e.g. by means of a piston rod of the injection device via the injection needle product from the product container

CH 712 891 A2. The injection needle can preferably be non-detachably formed on the product container. Furthermore, the product container can comprise a holding section, in particular a needle holding section, which is arranged distally of the product container section and is non-detachably connected to the injection needle. The needle holding portion of the product container can surround a proximal part of the injection needle. The injection needle can thus protrude from the holding section in the distal direction. The holding section can have a smaller outside diameter than the product container section. The product container section can taper at its distal end towards the holding section. The needle protection cap is arranged on the product container, in particular on the holding section of the product container, which cap encloses the injection needle and preferably seals it sterile from the environment.

The method further comprises moving or inserting the product container with the detachably connected needle cap into the housing along a longitudinal axis L in a distal direction, the engagement element being deformable or deformed such that when the product container is moved or inserted relative to the housing in the distal direction the needle cap is radially spaced from the engagement element. This ensures that no or very little force is exerted on the needle cap when the product container is inserted. This prevents the needle protection cap from being moved relative to the product container while the product container is being inserted. This reduces the risk that the sterility of the injection needle and the medication will suffer.

The engaging element is preferably deformable in such a way that the engaging element can be brought into engagement with the needle protection cap during the removal of the cap from the injection device.

In the spaced position of the engagement element, the engagement element can be undeformed, deformed or deformed radially outwards. In the engagement position of the engagement element, the engagement element can be undeformed, deformed or deformed radially inwards. The engagement element is plastically and / or elastically deformable. The engagement element is preferably formed from metal, in particular from steel, particularly preferably from stainless steel or from stainless spring steel. The engagement element is formed from a material which has a flexural strength which permits plastic and / or elastic deformation. The engagement element can particularly preferably be hook-shaped. The hook-shaped engagement element can comprise a short and a long leg. Alternatively, the engagement element can have a different configuration, the engagement element being radially spaced from the needle protection cap in the spaced-apart position of the engagement element and the engagement element being in engagement with the needle protection cap in the engagement position of the engagement element, the engagement element being deformed when the cap is removed.

Particularly preferably, the engaging element is designed such that it is plastically and / or elastically deformed in the spaced position of the engaging element and plastically and / or elastically undeformed in the engaged position or that it is plastically and / or in the spaced position of the engaging element is elastically undeformed and plastically and / or elastically deformed in the engagement position.

Particularly preferably, the engaging element in the spaced position of the engaging element can be plastically and / or elastically deformed radially outward or alternatively can be plastically and / or elastically undeformed. Particularly preferably, the engaging element in the engaging position of the engaging element can be plastically and / or elastically undeformed or, alternatively, plastically and / or elastically deformed radially inward. In the spaced-apart position of the engaging element, the long leg of the hook-shaped engaging element can particularly preferably be plastically and / or elastically deformed radially outwards or alternatively plastically and / or elastically undeformed and the short leg of the hook-shaped engaging element protrudes radially inwards. In the engaging position of the engaging element, the long leg of the hook-shaped engaging element can particularly preferably be plastically and / or elastically deformed or alternatively plastically and / or elastically deformed, in particular deformed radially inward, and the short leg of the hook-shaped engaging element protrudes radially inward, whereby the short leg of the engagement element engages with a jacket surface of the needle cap, in particular is always engaged.

Before moving or inserting the product container relative to the housing in the distal direction, in particular before moving or inserting the product container in the housing of the injection device, the engagement element is deformed, preferably radially outwardly deformed. For example, the long leg of the hook-shaped engaging element can be deformed, preferably deformed radially outward, in particular plastically and / or elastically deformed radially outward, the short leg projecting radially inward. An assembly tool can be used for this deformation in order to bring the engagement element into a spaced position in which the engagement element is radially spaced from the needle protection cap. The assembly tool can be designed as an assembly mandrel or as an expanding mandrel. The engaging element can be plastically and / or elastically deformed, the engaging element being formed from a plastic and / or elastic material.

The engagement element of the cap can be deformed before the detachable attachment of the cap to the housing of the injection device, preferably radially outwardly, in particular radially outwardly and plastically and / or elastically deformed. Alternatively, the engagement element of the cap can be deformed, preferably radially outward, in particular radially outward, plastically and / or elastically deformed after the cap has been detachably attached to the housing of the injection device. Alternatively, when the cap is attached to the housing, the engagement element can be deformed, preferably radially inwardly, in particular radially inwardly, plastically and / or elastically.

CH 712 891 A2 The engagement element can remain plastically and / or elastically deformed due to the material, in particular the flexural strength of the material, or alternatively by means of part of the injection device, in particular part of the housing or a product container holder, the product container being receivable in the product container holder , are kept in the plastic and / or elastic form.

On the housing or on a housing firmly connected part or on the product container holder, one or more locking elements are preferably provided which hold or bring the engagement element into engagement with the needle protection cap. The locking element has a first and / or a second inclined surface, in particular a first and / or a second inwardly projecting inclined surface. The first and / or the second inclined surface of the locking element can have an inclination. The first and second inclined surfaces can be inclined to one another. When the engaging member is engaged with the needle cap, the engaging member is in the engaged position. In the engaged position of the engaging element, the engaging element can form a firm, in particular axially and radially firm connection with the needle protection cap. The engagement element preferably connects to a lateral surface of the needle protection cap, the engagement element engaging or being drilled into the lateral surface of the needle protection cap. In the engagement position of the engagement element, the engagement element engages on or in the needle protection cap. The engagement element can engage on or in a lateral surface or on or in an edge or on or in a distal end surface or on or in a proximal end surface of the needle protection cap. Furthermore, the lateral surface of the needle protection cap can comprise one or more openings or one or more fastening means, wherein the engagement element can engage or drill into this opening or into this fastening means in the engagement position of the engagement element. Alternatively, the needle protection cap has no opening or no fastening means, the engagement element in the engagement position of the engagement element being able to engage or drill into the outer surface of the needle protection cap.

The engagement element may further comprise a fastening element. The fastening element can be firmly connected to the needle protection cap, in particular axially and / or radially, in the engagement position of the engagement element. The fastening element of the engagement element can be firmly connected to the outer surface or to an edge of the needle protection cap. One or more openings or one or more fastening means can be provided on the lateral surface or on the edge of the needle protection cap, wherein the fastening element of the engagement element can be firmly connected to the opening or the fastening means of the needle protection cap. Alternatively, the needle protection cap has no opening or no fastening means, wherein the fastening element of the engagement element can engage or drill into the lateral surface or into the edge of the needle protection cap.

The locking element can serve that the engaging element comes into the engaged position when the cap is removed. The engaging element, in particular the long leg of the hook-shaped engaging element, can slide along the first inclined surface of the locking element and deform, in particular plastically and / or elastically. During an axial movement or a combined axial-rotational movement of the cap relative to the housing of the injection device, the cap initially moves axially in the distal direction relative to the needle protection cap. When the pulling-off movement of the cap continues, the engagement element comes into engagement with the needle protection cap, the locking element, in particular the first inclined surface of the locking element, causing the engagement element to be brought into the undeformed configuration, deformed or deformed radially inward. For example, the long leg of the hook-shaped engaging element can be brought into the undeformed configuration, deformed or deformed radially inward, the short leg of the hook-shaped engaging element protruding radially inward and being in engagement with the needle protection cap, in particular always in engagement with the Needle cap is. After the engagement element is in the engagement position and the cap is pulled off further, the cap takes the needle protection cap with it. The injection device is available for an injection.

Alternatively, the locking element can be used to plastically and / or elastically deform the engagement element of the cap when mounting the injection device. When the cap is placed on the housing of the injection device, the locking element, in particular the second inclined surface of the locking element of the housing, can cause the engagement element of the cap to be deformed, in particular radially inwardly deformed. For example, the long leg of the hook-shaped engaging element can be deformed, in particular deformed radially inward, the short leg projecting radially inward. The engagement element of the cap slides over the inclined second surface of the locking element of the housing. At the end of the fitting movement of the cap, the engagement element can deform or can be brought or brought into the undeformed configuration or can be deformed radially outward. The engaging element of the cap moves transversely to the longitudinal axis L, the engaging element being positioned proximally offset from the locking element of the housing. When the cap is placed or attached to the housing of the injection device, the engagement element of the cap is preferably undeformed. For example, the long leg of the hook-shaped engagement element is undeformed, the short leg projecting radially inward.

Preferably, a needle protection sleeve, which is used to stand distally above or after the injection over the distal end of the injection needle, can at least partially be placed in the housing, the cap being placed on a distal end of the needle protection sleeve. The cap can e.g. be frictionally and / or positively connected to the needle protection sleeve, e.g. to be snapped.

[0042] In addition, reference is made to the features which are disclosed in connection with the device described here, which also advantageously further develop the device for the method.

CH 712 891 A2 The invention has been described with reference to several embodiments and examples. Particularly preferred embodiments of the invention are described below with reference to figures. The features disclosed thereby further develop the invention individually and in any combination of features. Show it:

Fig. 1 is a longitudinal sectional view of a first embodiment of an injection device according to the invention, wherein a cap (2) is detachably arranged on the injection device.

2a to 2g are longitudinal sectional views of the distal part of the injection devices from FIG. 1, the individual assembly steps for mounting the cap (2) on the injection device according to FIG. 1 being evident.

2h and 2i

Longitudinal sectional views of the distal part of the first embodiment of the injection device, wherein the removal of the cap (2) from the injection device can be seen.

3a to 3d are longitudinal sectional views of a distal part of a second embodiment of an injection device according to the invention, the individual assembly steps for mounting a cap (2) on this injection device being evident.

3e and 3f

Longitudinal sectional views of the distal part of the second embodiment of the injection device, wherein the removal of the cap (2) from the injection device can be seen.

4a to 4f are longitudinal sectional views of a distal part of a third embodiment of an injection device according to the invention, the individual assembly steps for mounting a cap (2) on this injection device being evident.

4g and 4h

Longitudinal sectional views of the distal part of the third embodiment of the injection device, wherein the removal of the cap (2) from the injection device can be seen.

5a to 5c are longitudinal sectional views of a distal part of a fourth embodiment of an injection device according to the invention, the individual assembly steps for mounting a cap (2) on this injection device being evident.

5d and 5e

Longitudinal sectional views of the distal part of the fourth embodiment of the injection device, wherein the removal of the cap (2) from the injection device can be seen.

1 shows a longitudinal sectional view of a first embodiment of an injection device according to the invention, a cap (2) being detachably arranged on the injection device. The injection device can, for example, have the cap (2) placed on the distal end in a delivery state. The injection device comprises a housing (1). The housing (1) can be designed as a sleeve-shaped, in particular cylindrical, receiving housing (1) with a distal and a proximal part. The cap (2) is detachably provided at the distal end of the housing (1). The cap (2) is detachably attached to the distal end of the housing (1) or alternatively to the distal end of the needle protection sleeve (7) via a positive connection, in particular via a snap connection. The cap (2) also has a sleeve (2b). The sleeve (2b) can preferably comprise an inner sleeve and an outer sleeve. The sleeve (2b) can preferably be made of plastic. In order to form the positive connection between the cap (2) and the housing (1), the cap (2) can have one or more engagement members (2a) which are arranged in counter-engagement members (1b) which are arranged on the housing (1) of the injection device. can intervene, in particular may be snapped. Like the housing (1), the sleeve (2b) extends along a longitudinal axis L of the injection device. By moving the cap (2) around and / or along the longitudinal axis L, the positive connection, in particular the snap connection between the cap (2) and the housing (1) or alternatively the needle protection sleeve (7) of the injection device can be released, the Cap (2) can be removed from the housing (1) of the injection device in the distal direction. The distal end of the sleeve (2b) is essentially closed, so that access from the outside into the interior of the cap (2) is not possible or only with difficulty.

The cap (2) comprises an engagement element (2c). The engagement element (2c) is plastically and / or elastically deformable. The engagement element (2c) is preferably formed from metal, in particular from steel, particularly preferably from stainless steel or from stainless spring steel. The engagement element (2c) is formed from a material which has a flexural strength which permits plastic and / or elastic deformation. The engagement element (2c) is deformable in such a way that it deforms, in particular deforms radially outwards or radially inwards, or assumes an undeformed configuration. The engagement element (2c) is deformable in such a way that it is deformed, in particular is or is deformed radially outwards or radially inwards or is not deformed. The engagement element (2c) is hook-shaped, the engagement element (2c) having a long and a short leg.

The cap (2) can also have a remover element (2d). The remover element (2d) is preferably sleeve-shaped, wherein the engagement element (2c) can be provided on the remover element (2d). The distance8

CH 712 891 A2 nerelement (2d) and the engagement element (2c) are preferably in one piece and preferably formed from the same material. The remover element (2d) and the engagement element (2c) are preferably formed from a stamped and bent part. The stamped and bent part is plastically and / or elastically deformable. The stamped and bent part is preferably formed from metal, in particular from steel, particularly preferably from stainless steel, in particular from stainless spring steel. The stamped and bent part is formed from a material which has a flexural strength which permits plastic and / or elastic deformation.

The sleeve (2b) can at least partially surround the engagement element (2c), in particular the remover element (2d) with the engagement element (2c). The sleeve (2b) and the remover element (2d) with the engagement element (2c) are axially fixed to one another. The sleeve (2b) and the remover element (2d) with the engagement element (2c) are formed in two parts. The remover element (2d) is axially fixedly connected to the sleeve (2b), in particular snapped in, glued, molded or snapped into place. For this purpose, the sleeve (2b), in particular the inner sleeve of the sleeve (2b), has a projection (2e) which is latched into a recess (2f) provided on the remover element (2d).

A product container (3) designed as a syringe is arranged in the housing (1) of the injection device. The product container (3) has a product container section (3a), which is in particular formed as a hollow cylinder and whose inner wall forms a sealing gap with a piston (3b) slidably received in the product container section (3a), so as to form a sterile barrier. A flange (3c), which is also referred to as a finger flange, can optionally be arranged at the proximal end of the product container section (3a). The product container section (3a) tapers at its distal end to a needle holding section (3d) which has a significantly smaller outside diameter than the product container section (3a). The needle holding section (3d) surrounds the proximal part of an injection needle (3e) and is preferably permanently connected to it. The product container (3) has a firmly connected injection needle (3e). The injection needle (3e) protrudes from the needle holding section (3d) in the distal direction. By moving the plunger (3b) in the distal direction, the product, preferably liquid product, arranged between the injection needle (3d) and the plunger (3b) in the product container section (3a) can be dispensed through the injection needle (3e).

In order to move the piston (3b) of the product container (3) in the distal direction, a drive unit can be provided in the housing (1) of the injection device. Alternatively, the drive unit can be non-positively and / or positively and / or cohesively connected to the housing (1) of the injection device. The drive unit can comprise a piston rod (4). By moving the piston rod (4) in the distal direction, a product can be poured out of the product container (3).

A needle protection cap (5) can be detached from the needle holding section (3d), e.g. positively and / or frictionally attached. The needle protection cap (5) can be a rigid needle shield (RNS) or alternatively a soft needle shield (SNS). The needle protection cap (5) surrounds the injection needle (3e) and seals the injection needle (3e) sterile to the environment. The needle protection cap (5) surrounds the injection needle (3e) in such a way that its sterility with respect to the environment is guaranteed.

The engagement element (2c) of the cap (2) is deformable in such a way that the engagement element (2c) from a spaced position, in which the engagement element (2c) is radially spaced from the needle protection cap (5), into an engagement position of the engagement element (2c), in which the engagement element (2c) is in engagement with the needle protection cap (5), can be reached, the engagement element (2c) being deformed when the cap is removed.

This ensures that when the product container (3) is inserted into the housing (1) of the injection device, no or very few forces, in particular no or very few forces exerted by the engagement element (2c), act on the needle protection cap (5).

On the housing (1) of the injection device or on a housing (1) firmly connected part of the injection device, a locking element (1a) is provided. The locking element (1a) has at least a first inclined surface. The first inclined surface of the locking element (1a) protrudes inwards. The first inclined surface of the locking element (1a) has an incline. Alternatively, the locking element (1a) can be provided on the product container holder (3). When pulling off the cap (2) from the housing (1), the engagement element (2c) of the cap (2) with the locking element (1 a), in particular with the first inclined surface of the locking element (1 a) of the housing (1) Interacting so that the engaging element (2c) of the cap (2) comes into the engaging position, the engaging element (2c) of the cap (2) coming into engagement with the needle protection cap (5). The locking element (1a) of the housing (1) holds or brings the engagement element (2c) of the cap (2) into the engagement position of the engagement element (2c).

The product container (3) can optionally in a e.g. sleeve-shaped product container holder (6) can be arranged. The tapering section of the product container section (3a) can be supported in the distal direction, for example, on an inwardly projecting shoulder of the product container holder (6). Alternatively, the flange (3c) of the product container (3) can be supported on the product container holder (6) in the distal direction. Still further alternatively, the product container holder (6) can hold the product container (3) by friction on its product container section (3a). The product container holder (6) can e.g. axially fixed or displaceable in the housing (1) of the injection device.

In the housing (1) of the injection device, a needle protection sleeve (7) can optionally be arranged, which in relation to the housing (1) of the injection device for triggering a product release in the proximal direction

CH 712 891 A2 and after the product has been dispensed can be moved in the distal direction in order to cover the tip of the injection needle (3e) in order to reduce the risk of injury. Furthermore or alternatively the sleeve (2) can e.g. be releasably connected to the needle protection sleeve (7) via a snap connection. Such needle protection sleeves (7) are known from the prior art and can be regarded as an advantageous development of the invention.

The injection device according to the invention can have any configuration, provided that the injection device comprises a product container (3) in a housing (1). The injection device can be designed as an auto-injector known from the prior art, in which the product is automatically poured out. However, other injection devices can also be provided.

2 a to 2 g are longitudinal sectional views of the distal part of the injection devices from FIG. 1, the individual assembly steps for mounting the cap (2) on the injection device according to FIG. 1 being shown. Furthermore, FIGS. 2h and 2i show longitudinal sectional views of the distal part of the injection device from FIG. 1, the removal of the cap (2) from the injection device being shown. The sleeve-shaped product container holder (6) is placed on an assembly tool (8), in particular on an assembly tool dome (8). The product container holder (6) is displaced from the distal end of the assembly tool (8) relative to the assembly tool (8). The product container holder (6) is moved on the assembly tool (8) in the proximal direction until the product container holder (6) assumes a proximal position. The product container holder (6) serves to hold the product container (3). The sleeve-shaped remover element (2d) of the cap (2), which comprises an engagement element (2c), is then placed on the assembly tool (8). The engagement element (2c) of the cap (2) is deformed radially outwards, in particular elastically and / or plastically radially outwards. The long leg of the hook-shaped engaging element (2c) is elastically and / or plastically deformed radially outward, the short leg of the hook-shaped engaging element (2c) protruding radially inward. The radially outwardly deformed engaging element (2c) slides in the proximal direction over the distal end of the product container holder (6) during displacement relative to the assembly tool (8), the remover element (2d) taking up a distal position. The outwardly deformed engaging element (2c), in particular the elastically and / or plastically radially outwardly deformed long leg and / or the short leg of the engaging element (2c) is supported on the distal end of the product container (6). This support serves to prevent premature engagement between the engagement element (2c) and the needle protection cap (5). Then the housing (1) is placed on the assembly tool (8). The housing (1) is displaced in the proximal direction relative to the assembly tool (8) until the locking element (1a) provided on the housing (1), in particular the first inclined surface of the locking element (1a), extends radially outward deformed engaging elements (2c), in particular in the region of the radially outwardly deformed long leg of the hook-shaped engaging element (2c), but preferably does not touch.

The radially outwardly deformed engagement element (2c) and the first inclined surface of the locking element (1a) are arranged approximately parallel to each other. Alternatively, the product container holder (6) and the housing (1) can be formed in one piece, wherein the step of putting the product container holder (6) on can be omitted. Furthermore, a needle protection sleeve (7) can be placed on the assembly tool (8), the needle protection sleeve (7) being displaced relative to the assembly tool (8) by the distal end of the assembly tool (8). The needle protection sleeve (7) is at least partially placed in the housing (1) of the injection device. Alternatively, the injection device can not comprise a needle protection sleeve (7), this step can be omitted. Then the sleeve (2b) of the cap (2) can be placed on the assembly tool (8). The sleeve (2b) of the cap (2) is attached to the distal end of the housing (1). The sleeve (2b) is releasably connected to the housing (1) or alternatively to the needle protection sleeve (7), in particular via a snap connection. The sleeve (2b), in particular the outer sleeve of the sleeve (2b), comprises one or more engagement members (2a) which can engage in counter-engagement members (1b) provided on the housing (1). The projection (2e) provided on the sleeve (2b), in particular on the inner sleeve of the sleeve (2b), snaps into the recess (2f) provided on the remover element (2d). The sleeve (2b) is axially fixed to the remover element (2d). The sleeve (2b), in particular the outer sleeve of the sleeve (2b), partially surrounds the needle protection sleeve (7). The sleeve (2b) is placed on the distal end of the needle protection sleeve (7). Then the assembly tool (8) is removed. The assembly consisting of at least the housing (1) and the cap (2), the cap (2) comprising the engaging element (2c), can optionally be delivered to another assembly location for further assembly. To produce the injection device, the product container (3) can be placed in the product container holder (6) or in the housing (1) of the injection device. No or very few forces are exerted by the engagement element (2c) of the cap (2) on the needle protection cap (5), which is detachably arranged on the product container (2). The injection needle (3e) of the product container (3) is sterile sealed from the environment by the needle protection cap (5). The product container (3) pre-filled with a product is inserted into the housing (1) from a proximal end of the housing (1). The product container (3) is displaced in the distal direction until a distal end position is reached relative to the product container holder (6) or to the housing (1). The engagement element (2c) of the cap (2) is in the spaced position in which the engagement element (2c) is radially spaced from the needle protection cap (5) which is arranged on the product container (3). A drive unit can then be placed in the housing (1) of the injection device. The drive unit can be inserted into the housing (1) from the proximal end of the housing (1). Alternatively, the drive unit can be non-positively and / or positively and / or cohesively connected to the housing (1) of the injection device. The injection device is installed. The injection device is in the delivery state. To use the injection device, the cap (2) of the

CH 712 891 A2 distal end of the housing (1) of the injection device removed. The positive connection between the sleeve (2b), in particular the outer sleeve of the sleeve (2b) of the cap (2), in particular the engagement member (2a) of the sleeve (2b) and the housing (1), in particular the counter-engagement member (1b) of the housing (1) released. Because of the axially fixed connection between the sleeve (2b) and the remover element (2d), the remover element (2d) being axially fixed to the engagement element (2c), the sleeve (2b) moves relative to the housing (1) in the distal direction. During this movement, the engaging element (2c), in particular the long leg of the hook-shaped engaging element (2c) of the cap (2), slides over the first inclined surface of the locking element (1a) of the housing (1) of the injection device, the engaging element (2c) deformed in such a way that the engagement element (2c) comes into engagement with the needle protection cap (5). The engagement element (2c) of the cap (2) comes into the engagement position in which the engagement element (2c) is in engagement with the needle protection cap (5), the engagement element (2c) deforming, in particular plastically and, when the cap (2) is removed / or is elastically deformed. The engaging element (2c), in particular the long leg of the hook-shaped engaging element (2c), preferably reaches an undeformed or a radially inwardly deformed configuration, the engaging element (2c), in particular the short leg of the hook-shaped engaging element (2c), having an axial shape firm connection with the needle protection cap (5). The engaging element (2c), in particular the short leg of the hook-shaped engaging element (2c), engages or drills itself into a lateral surface of the needle protection cap (5). When the pull-off movement is continued, the needle protection cap (5) is taken away from the cap (2), the needle protection cap (5) being removed from the product container (3) and being held in the cap (2). The needle protection cap (5) is received by the cap (2). The injection device can be used to administer the product.

3a to 3d are longitudinal sectional views of a distal part of a second embodiment of an injection device according to the invention, the individual assembly steps for mounting a cap (2) on this injection device being shown. 3e and 3f also show longitudinal sectional views of the distal part of the second embodiment of the injection device, the removal of the cap (2) from the injection device being shown. In several assembly steps, a product container holder (6 ') and a needle protection sleeve (7') are arranged in a housing (1 ') of the injection device. Alternatively, the housing (1 ') and the product container (6') can be formed in one piece, wherein the step of inserting the product container holder (6 ') into the housing (1') can be omitted. Alternatively, the injection device may not have a needle protection sleeve (7), and the step of inserting the needle protection sleeve (7) into the housing (1 ') can be omitted. A locking element (1a ') is provided on the housing (1') or on a part firmly connected to a housing (1 '). The locking element (1a1) has at least a first inclined surface. The first sloping surface protrudes inwards. The first sloping surface has an incline. A cap (2) is also arranged at a distal end of the housing (1). The cap (2) comprises a sleeve (2b '), a remover element (2d') and an engagement element (2c '). The sleeve (2b ') can comprise an outer sleeve and an inner sleeve. The sleeve (2b '), the remover element (2d') and the engagement element (2c ') are preferably axially fixed to one another. The sleeve (2b1) partially surrounds the engagement element (2c '), in particular the remover element (2d) and the engagement element (2c1). The remover element (2d) and the engagement element (2c1) are preferably formed in one piece, the sleeve (2b ') forming a separate part. The remover element (2d ') and the engagement element (2c') are preferably formed from a stamped and bent part. The remover element (2d) is preferably axially fixed to the sleeve (2b ') via a projection-recess connection (2e', 2f '). The engagement element (2c ') is preferably formed from metal, in particular from steel, particularly preferably from stainless steel or from stainless spring steel. The engaging element (2c1) or the stamped and bent part is formed from a material which has a bending strength which permits plastic and / or elastic deformation. The engagement element (2c1) is deformable in such a way that it deforms, in particular deforms radially outwards or radially inwards, or assumes an undeformed configuration. The engagement element (2c ') is deformable in such a way that it is deformed, in particular is or is deformed radially outwards or radially inwards or is not deformed. The engagement element (2c ') is hook-shaped. The hook-shaped engagement element (2c ') comprises a long and a short leg. The short leg of the hook-shaped engaging element (2c1) protrudes against the inside of the injection device in the direction of the longitudinal axis L of the injection device. When the cap (2) is placed on the distal end of the housing (1 '), the engaging element (2c'), in particular the long leg of the hook-shaped engaging element (2c '), is designed to be undeformed. When the cap (2) is placed on the injection device, the engagement element (2c ') moves axially relative to the locking element (1a1) of the housing (1') in the proximal direction, the engagement element (2c ') not deforming, in particular not plastically and / or is elastically deformed. An engagement member (2a ') provided on the sleeve (2b1) of the cap (2) engages in a mating engagement member (1b') arranged on the housing. In order to further assemble the injection device, an assembly tool (8 '), in particular an expanding mandrel (8'), is guided into the injection device from the proximal end of the housing (1 ') of the injection device. The expanding mandrel (8 ') comprises one or more bending elements (8a) which can deform the engagement element (2c'), in particular can deform radially outwards. The engaging element (2c ') of the cap (2) is deformed, in particular plastically and / or elastically, parallel to the first inclined surface of the locking element (1 a1) of the housing (1). The bending element (8a) of the expanding mandrel (8 ') is moved from a longitudinal axis L of the injection device transversely to the longitudinal axis L of the injection device and then again into the longitudinal axis L. The assembly tool (8 '), in particular the expansion dome (8'), is pulled out of the injection device. The assembly consisting of at least the housing (1 ') and the cap (2), the cap (2) comprising the engaging element (2c'), can optionally be delivered to another assembly location for further assembly. A product container (3 ') can be placed in the product container holder (6') or in the housing (1 ') of the injection device

CH 712 891 A2. Due to the radially outwardly deformed engagement element (2c ') of the cap (2), when the product container (3') is inserted with the needle protection cap (5 '), no or very few forces are exerted by the engagement element (2c1) of the cap (2) Needle protection cap (5 ') exercised. An injection needle (3e) arranged on the product container (3 ') is sterile sealed from the surroundings by the needle protection cap (5'). The product container (3 ') pre-filled with a product is inserted into the housing (1') from a proximal end of the housing (1 '). The product container (3 ') is displaced in the distal direction until a distal end position is reached relative to the product container holder (6') or to the housing (1 '). The engagement element (2c ') of the cap (2) is in the spaced position in which the engagement element (2c') is radially spaced from the needle protection cap (5 ') which is arranged on the product container (3'). A drive unit can then be placed in the housing (1 ') of the injection device. The drive unit can be inserted into the housing (1 ') from the proximal end of the housing (1'). Alternatively, the drive unit can be non-positively and / or positively and / or cohesively connected to the housing (1 ') of the injection device. The injection device is installed. The injection device is in the delivery state. To use the injection device, the cap (2) is removed from the distal end of the housing (1 ') of the injection device. The positive connection between the sleeve (2b1) of the cap (2 '), in particular the engagement member (2a') of the sleeve (2b ') and the housing (1), in particular the counter-engagement member (1b1) of the housing, is released. The cap (2) moves relative to the housing (1) in the distal direction. During this movement, the engagement element (2c '), in particular the long leg of the hook-shaped engagement element (2c') of the cap (2), slides over the first inclined surface of the locking element (1 a1) of the housing (1 ') of the injection device. The engaging element (2a1) is deformed in such a way that the engaging element (2c ') comes into engagement with the needle protection cap (5'). The engagement element (2c ') of the cap (2) reaches the engagement position in which the engagement element (2c') is in engagement with the needle protection cap (5 '), the engagement element (2c') deforming, in particular plastically, when the cap is removed and / or is elastically deformed. The engaging element (2c ') preferably has an undeformed or a radially inwardly deformed configuration. The engaging element (2c1) is in axially fixed connection with the needle protection cap (5 '). The engagement element (2c1), in particular the short leg of the hook-shaped engagement element (2c '), engages or drills itself into a lateral surface of the needle protection cap (5'). The needle protection cap (5 ') is carried along by the cap (2), the needle protection cap (5') being removed from the product container (3 ') and being held in the cap (2). The injection device can be used to administer the product.

4a to 4f show longitudinal sectional views of a distal part of a third embodiment of an injection device according to the invention, the individual assembly steps for mounting the cap (2) on this injection device being shown. Furthermore, FIGS. 4g and 4h show longitudinal sectional views of the distal part of the third embodiment of the injection device, the removal of the cap (2) from the injection device being shown. A product container holder (6) and a needle protection sleeve (7) are initially inserted into a housing (1) of the injection device. In another embodiment of the invention, the housing (1) and the product container (6) can alternatively be formed in one piece, wherein the step of inserting the product container holder (6) into the housing (1) can be omitted. In a further embodiment, the injection device can have no needle protection sleeve (7), the step of inserting the needle protection sleeve (7) into the housing (1 ') can be omitted. A locking element (1a) is arranged on the housing (1) or on a part which is firmly connected to a housing (1), the locking element (1a) comprising at least one first inclined surface. The first inclined surface of the locking element (1a) protrudes inwards. The first sloping surface has an incline. In a further step, a cap (2) is attached to a distal end of the housing (1). The cap (2) preferably has a sleeve (2b), a remover element (2d) and an engagement element (2c). The sleeve (2b), the remover element (2d) and the engagement element (2c) are preferably axially fixed to one another. Alternatively, the sleeve (2b), the remover element (2d) and the engagement element (2c) can be formed in one piece. The sleeve (2b) partially surrounds the engaging element (2c), in particular the remover element (2d) and the engaging element (2c). The remover element (2d) and the engagement element (2c) are preferably formed in one piece, the sleeve (2b) forming a separate part. The remover element (2d) and the engagement element (2c) are preferably formed from a stamped and bent part. The remover element (2d) is preferably axially fixed to the sleeve (2b) via a projection-recess connection (2e, 2f). The engagement element (2c) is preferably formed from metal, in particular from steel, particularly preferably from stainless steel or from stainless spring steel. The engagement element (2c) is formed from a material which has a flexural strength which permits plastic and / or elastic deformation. The engagement element (2c) is deformable in such a way that it deforms, in particular deforms radially outwards or radially inwards, or assumes an undeformed configuration. The engagement element (2c) is deformable in such a way that it is deformed, in particular is or is deformed radially outwards or radially inwards or is not deformed. The engagement element (2c) can be hook-shaped. The hook-shaped engagement element (2c) has a long and a short leg. When the cap (2) is attached to the distal end of the housing (1), the engagement element (2c), in particular the long leg of the hook-shaped engagement element (2c), is designed to be undeformed. When the cap (2) is placed on the distal end of the injection device, the engagement element (2c) moves relative to the locking element (1a) of the housing (1) in the proximal direction, the engagement element (2c) not being deformed, in particular not plastically and / or is elastically deformed. At the end of the fitting movement of the cap (2), an engagement member (2a) provided on the sleeve (2b) engages in a counter-engagement member (1b) arranged on the housing. In a further step, an assembly tool (8) is removed from the proximal end of the housing (1) of the injection device,

CH 712 891 A2, in particular an expanding mandrel (8) is inserted into the injection device. One or more bending elements of the expanding mandrel (8) deform the engaging element (2c) .The engaging element (2c) is deformed radially outward by the expanding mandrel (8) in such a way that the engaging element (2c) is approximately parallel to the first inclined surface of the locking element ( 1a) of the housing (V) is deformed, in particular plastically and / or elastically deformed. The bending element of the expansion dome (8) is moved from a longitudinal axis L of the injection device transversely to the longitudinal axis L of the injection device and then again into the longitudinal axis L. After the plastic and / or elastic deformation of the engagement element (2c) of the cap (2), the expanding mandrel (8) is guided out of the injection device. Particularly preferably, before or after removing the assembly tool (8), in particular the expanding mandrel (8), the product container holder (6) can be displaced in the distal direction relative to the housing (1) such that the deformed, in particular the plastic and / or elastically deformed engaging element (2c), in particular the long leg of the hook-shaped engaging element (2c) of the cap (2) comes to rest over a distal end of the product container holder (6). The outwardly deformed engaging element (2c), in particular the elastically and / or plastically radially outwardly deformed long leg and / or the short leg of the engaging element (2c) is supported on the distal end of the product container (6). This support serves to prevent premature engagement between the engagement element (2c) and the needle protection cap (5). The distal end of the product container holder (6) can hold the engagement element (2c) in the deformed configuration. The assembly, which comprises at least the housing (1) and the cap (2), can optionally be delivered to another assembly location for further assembly. A product container (3) pre-filled with a product can be placed in the product container holder (6) or in the housing (1) of the injection device. Due to the radially outwardly deformed engagement element (2c) of the cap (2), when the product container (3 ) with the needle protection cap (5) no or very few forces exerted by the engagement element (2c) of the cap (2) on the needle protection cap (5). An injection needle (3e) of the product container (3) is sterile sealed from the environment by the needle protection cap (5). The product container (3) is inserted into the housing (1) from a proximal end of the housing (1), the product container (3) being in relative to the product container holder (6) or to the housing (1) until it reaches a distal end position the distal direction is shifted. The engaging element (2c) of the cap (2) is in the spaced-apart position in which the engaging element (2c) is radially spaced from the needle protection cap (5). In a further step, a drive unit can be inserted into the housing (1) of the injection device. The drive unit can also be inserted into the housing (1) from the proximal end of the housing (1). In other embodiments, the drive unit can be connected to the housing (1) of the injection device in a force-fitting and / or form-fitting and / or material-locking manner. The injection device is in the delivery state. To use the injection device, the cap (2) is removed from the distal end of the housing (1) of the injection device. The positive connection between the sleeve (2b) of the cap (2) and the housing (1) is released. The cap (2) moves relative to the housing (1) in the distal direction. During this axial movement or combined axial-rotary movement, the engagement element (2c), in particular the long leg of the hook-shaped engagement element (2c) of the cap (2), slides over the first inclined surface of the locking element (1a) of the housing (1) of the injection device. The engaging element (2c) is deformed in such a way that the engaging element (2c) comes into engagement with the needle protection cap (5). Alternatively, the engagement element (2c) deforms without the action of the locking element (1a), in particular in the undeformed configuration. The engagement element (2c) of the cap (2) comes into the engagement position, in which the engagement element (2c) is in engagement with the needle protection cap (5), the engagement element (2c) being deformed when the cap (2) is removed. The engaging element (2c) preferably arrives in an undeformed or in a radially inwardly deformed configuration. The engagement element (2c) is in an axially fixed connection with the needle protection cap (5). The engagement element (2c), in particular the short leg of the hook-shaped engagement element (2c), engages or drills itself into a lateral surface of the needle protection cap (5). The needle protection cap (5) is taken away by the cap (2). The injection device can be used to administer the product.

5a to 5c are longitudinal sectional views of a distal part of a fourth embodiment of an injection device according to the invention, the individual assembly steps for mounting the cap on this injection device being shown. Furthermore, FIGS. 5d and 5e show longitudinal sectional views of the distal part of the fourth embodiment of the injection device, the removal of the cap (2) from the injection device being shown. In one step, a housing (1 ') is provided which has a product container holder (6') and a needle protection sleeve (6 '). Alternatively, the housing (1 ') and the product container holder (6') can be formed in one piece. In a further exemplary embodiment, the injection device can have no needle protection sleeve (7 '), at least one housing (1') of the injection device being provided. A locking element (1a ') is provided on the housing (1') or on a part firmly connected to a housing (1 '). The locking element (1a ') has at least a first and a second inclined surface. The first and second sloping surfaces protrude inwards. The first and the second inclined surfaces each have an inclination. The first and second inclined surfaces are inclined to each other. A cap (2 ') is also provided. The cap (2 ') comprises a sleeve (2b'), a remover element (2d) and an engagement element (2c '). The sleeve (2b '), the remover element (2d) and the engagement element (2c') are preferably axially fixed to one another. The sleeve (2b ') partially surrounds the engagement element (2c'), in particular the remover element (2d) with the engagement element (2c '). The remover element (2d ') and the engagement element (2c') are preferably formed in one piece, the sleeve (2b ') forming a separate part. The remover element (2d) and the engagement element (2c ') are preferably formed from a stamped and bent part. The sleeve-shaped remover element (2d) is preferably axially fixed to the sleeve (2b ') via a projection-recess connection (2e', 2f). The

CH 712 891 A2

The engagement element (2c ') or the stamped and bent part is preferably formed from metal, in particular from steel, particularly preferably from stainless steel or from stainless spring steel. The engaging element (2c ') or the stamped and bent part is formed from a material which has a flexural strength which permits plastic and / or elastic deformation. The engagement element (2c ') can be deformed in such a way that it deforms, in particular deforms radially outwards or radially inwards, or assumes an undeformed configuration. The engagement element (2c ') is deformable in such a way that it is deformed, in particular is or is deformed radially outwards or radially inwards or is not deformed. The engagement element (2c ') can be hook-shaped. The cap (2 ') is placed on a distal end of the housing (1'), the engagement element (2c '), in particular the long leg of the hook-shaped engagement element (2c'), being undeformed. When the cap (2 ') is placed on the distal end of the injection device, the engagement element (2c') is moved in the proximal direction relative to the locking element (1a ') of the housing (1'), the engagement element (2c '), in particular the long leg of the hook-shaped engaging element (2c ') is deformed radially inwards, in particular is elastically deformed radially inwards. When the engaging element (2c ') reaches a position which is proximally offset from the locking element (1a') of the housing (1 '), the engaging element (2c') returns to its undeformed configuration. At the same time or when the movement is continued, an engagement member (2a ') provided on the sleeve (2b') of the cap (2 ') engages in a counter-engagement member (1b') arranged on the housing and forms a detachable connection. The assembly consisting of at least the housing (1 ') and the cap (2), the cap (2') comprising the engaging element (2c ') can optionally be delivered to another assembly location for further assembly. A product container (3 ') pre-filled with a product can be placed in the product container holder (6') or in the housing (1 ') of the injection device. Due to the undeformed engagement element (2c ') of the cap (2'), when the product container (3 ') is inserted with the needle protection cap (5'), no or very few forces are exerted by the engagement element (2c1) of the cap (2 ') on the needle protection cap (5 ') exercised. An injection needle (3e ') provided on the product container (3') is sterile sealed from the surroundings by the needle protection cap (5 '). The product container (3 ') pre-filled with a product is inserted into the housing (1') from a proximal end of the housing (1 '). The product container (3 ') is displaced in the distal direction until a distal end position is reached relative to the product container holder (6') or to the housing (1 '). The engagement element (2c ') of the cap (2') is in the spaced position in which the engagement element (2c ') is radially spaced from the needle protection cap (5'). In a further step, a drive unit can be placed in the housing (1 ') of the injection device. The drive unit can be inserted into the housing (1 ') from the proximal end of the housing (1'). Alternatively, the drive unit can be connected to the housing (1 ') of the injection device in a force-fitting and / or form-fitting and / or integral manner. The injection device is installed. The injection device is in the delivery state. To use the injection device, the cap (2 ') is removed from the distal end of the housing (1') of the injection device. The positive connection between the sleeve (2b ') of the cap (2') and the housing (1 ') is released. The cap (2 ') moves relative to the housing (1') in the distal direction. During this movement, the engagement element (2c '), in particular the long leg of the hook-shaped engagement element (2c') of the cap (2 '), slides over the first inclined surface of the locking element (1a') of the housing (1 ') of the injection device. The engaging element (2a ') is deformed, in particular plastically and / or elastically deformed, such that the engaging element (2c') comes into engagement with the needle protection cap (5 '). The engagement element (2c ') of the cap (2') reaches the engagement position in which the engagement element (2c ') is in engagement with the needle protection cap (5'), the engagement element (2c ') being deformed when the cap is removed. The engagement element (2c ') deforms, in particular plastically and / or elastically, radially inwards. The engagement element (2c ') preferably further comprises one or more fastening elements, the fastening element being designed such that it has a fixed, in particular an axially and radially fixed connection with a needle protection cap (5'), in particular with a lateral surface of the needle protection cap (5 ' ) can enter. The needle protection cap (5 ') is consequently entrained by the cap (2') when the cap (2 ') is pulled off. The injection device can be used to administer the product.

Reference numerals:

[0063]

1, Γ, 1, 1

casing

1a, 1a ', 1a, 1a

1b, 1b ', 1b, 1b

blocking element

Against engaging member

2, 2 ', 2, 2

cap

2a, 2a ', 2a, 2a

engaging member

2b, 2b ', 2b, 2b

shell

2c, 2c ', 2c, 2c'

engaging member

2d, 2d ', 2d, 2d

remover element

CH 712 891 A2

2e, 2e ', 2e, 2e head Start 2f, 2f ', 2f, 2Γ recess 3, 3 ', 3, 3 product container 3a, 3a ', 3a, 3a' Product container section 3b piston 3c flange 3d, 3d ', 3d, 3d' Needle-holding section 3e, 3e ', 3e, 3e injection needle 4 piston rod 5, 5 ', 5, 5' Needle cap 6, 6 ', 6, 6 Product container holder 7, 7 ', 7, 7 Needle guard 8, 8 ', 8 assembly tool 8a flexure L longitudinal axis

Claims (15)

claims 1. Injection device with: - A housing (1, 1 1, 1 ') for receiving a product container (3, 3', 3, 3 '), the product container (3, 3', 3, 3 ') being a firmly connected injection needle (3e, 3e ', 3e, 3e'), wherein a needle protection cap (5, 5 ', 5, 5') is detachably arranged on the product container (3, 3 ', 3, 3'), which covers the injection needle (3e, 3e ', 3e, 3e ') and sterile sealing from the environment, - a cap (2, 2 ', 2, 2') which is detachably provided on a distal end of the housing (1, 1 ', 1, 1'), the cap (2,2 ', 2, 2) an engagement element (2c, 2c ', 2c, 2c') comprises, when removing the cap (2,2 ', 2, 2) from the injection device, the removal of the needle protection cap (5, 5', 5, 5 ') from the To effect product container (3, 3 ', 3, 3'), characterized in that the engagement element (2c, 2c ', 2c, 2c') is deformable such that the engagement element (2c, 2c ', 2c, 2c') from a spaced position, in which the engagement element (2c, 2c ', 2c, 2c') is radially spaced from the needle cap (5, 5 ', 5, 5'), to an engagement position in which the engagement element (2c, 2c ', 2c, 2c') in engagement with the needle protection cap (5, 5 ', 5, 5') can be reached, the engagement element (2c, 2c ', 2c, 2c') when the cap (2, 2 ', 2, 2) is deformed. 2. Injection device according to claim 1, characterized in that in the spaced position the engagement element (2c, 2c ', 2c, 2c') is undeformed, deformed or deformed radially outwards. 3. Injection device according to claim 1 or 2, characterized in that in the engagement position, the engagement element (2c, 2c ', 2c, 2c') is undeformed, deformed or deformed radially inwards. 4. Injection device according to one of the preceding claims, characterized in that the engagement element (2c, 2c ', 2c, 2c') is plastically and / or elastically deformable. 5. Injection device according to one of the preceding claims, characterized in that the engagement element (2c, 2c ', 2c, 2c') is hook-shaped. 6. Injection device according to one of the preceding claims, characterized in that the engagement element (2c, 2c ', 2c, 2c') with the cap (2, 2 ', 2, 2) is axially fixedly connected. 7. Injection device according to one of the preceding claims, characterized in that the cap (2, 2 ', 2, 2') further comprises a sleeve (2b, 2b ', 2b, 2b'), the sleeve (2b, 2b ' , 2b, 2b ') at least partially comprises the engaging element (2c, 2c', 2c, 2c ') and that the engaging element (2c, 2c', 2c, 2c ') with the sleeve (2, 2', 2, 2 ) is axially fixed. 8. Injection device according to one of the preceding claims, characterized in that on the housing (1, 1 ', 1, 1) or on a housing (1, 1', 1, 1) firmly connected part a locking element (1a, 1a ' , 1a, 1a ') CH 712 891 A2 is provided, wherein in the engaged position of the engaging element (2c, 2c ', 2c, 2c') the locking element (1a, 1a ', 1a, 1a') the engaging element (2c, 2c ', 2c, 2c') holds or brings into engagement with the needle protection cap (5, 5 ', 5, 5'). 9. A method, in particular for assembling an injection device and / or preparing an injection device for the administration of a product, comprising the following steps: - Providing a housing (1, 1 ', 1, 1) for receiving a product container (3, 3', 3, 3 '), - Providing a cap (2, 2 ', 2, 2) which is detachably attached to a distal end of the housing (1, 1', 1, 1), the cap (2, 2 ', 2, 2) Engagement element (2c, 2c ', 2c, 2c') comprises, when removing the cap (2, 2 ', 2, 2) from the injection device, the removal of the needle protection cap (5, 5', 5, 5 ') from the product container (3, 3 ', 3, 3'), - Providing a product container (3, 3 ', 3, 3') which has a firmly connected injection needle (3e, 3e ', 3e, 3e'), one on the product container (3, 3 ', 3, 3') Needle protection cap (5, 5 ', 5, 5') is detachably arranged, which surrounds the injection needle (3e, 3e ', 3e, 3e') and seals it sterile from the environment, characterized by - Moving or inserting the product container (3, 3 ', 3, 3') with the detachably connected needle cap (5, 5 ', 5, 5') into the housing (1, Γ, 1, 1) along a longitudinal axis L in a distal direction, the engagement element (2c, 2c ', 2c, 2c') being deformable in such a way that when the product container (3, 3 ', 3, 3') is moved relative to the housing (1, 1 ', 1, 1 ') in the distal direction, the needle protection cap (5, 5', 5, 5 ') is radially spaced from the engagement element (2c, 2c', 2c, 2c '). 10. The method according to claim 9, characterized in that the engagement element (2c, 2c ', 2c, 2c') is deformable in such a way that during the removal of the cap (2, 2 ', 2, 2) from the injection device, the engagement element ( 2c, 2c ', 2c, 2c') is brought into engagement with the needle protection cap (5, 5 ', 5, 5'). 11. The method according to claim 10, characterized in that on the housing (1, 1 ', 1, 1') or on a housing (1, 1 ', 1, 1') firmly connected part a locking element (1a, 1a ' , 1a, 1a ') is provided, which brings the engagement element (2c, 2c', 2c, 2c ') into engagement with the needle protection cap (5, 5', 5, 5 '). 12. The method according to any one of claims 10 to 11, characterized in that the engagement element (2c, 2c ', 2c, 2c') is plastically and / or elastically deformed. 13. The method according to any one of claims 10 to 12, characterized in that prior to moving the product container (3, 3 ', 3, 3') relative to the housing (1, 1 ', 1, 1'), the engagement element (2c, 2c ', 2c, 2c') is not deformed, deformed or deformed radially outwards. 14. The method according to claim 13, characterized in that an assembly tool (8, 8 ', 8, 8') is used to move the engagement element (2c, 2c ', 2c, 2c') into a spaced position, in which the engagement element (2c, 2c ', 2c, 2c') from the needle cap (5, 5 ', 5, 5') is radially spaced. 15. The method according to any one of claims 10 to 14, characterized in that a needle protection sleeve (7, 7 ', 7, 7') is at least partially placed in the housing (1,1 ', 1, 1), with a distal The cap (2, 2 ', 2, 2') is placed on the end of the needle protection sleeve (7, 7 ', 7, 7). CH 712 891 A2 CH 712 891 A2