INJECTION DEVICE WITH A CAP FOR REMOVING A NEEDLE GUARD CAP FROM A PRODUCT CONTAINER AND METHOD FOR PREPARING SUCH A DEVICE

Description

[0001] The invention relates to an injection device for administering a liquid product, in particular a drug.

[0002] The term "medicinal product" here encompasses any flowable medical formulation suitable for controlled administration through a means such as a cannula or injection needle, for example, comprising a liquid, solution, gel, or fine suspension containing one or more medicinal active ingredients. A medicinal product may be a composition with a single active ingredient or a premixed or co-formulated composition with multiple active ingredients from a single container. Medicinal products include drugs such as peptides (e.g.,Insulins, insulin-containing medications, GLP-1-containing and derived or analogous preparations), proteins and hormones, biologically derived or active substances, hormone- or gene-based active substances, nutritional formulations, enzymes and other substances in solid (suspended) or liquid form, as well as polysaccharides, vaccines, DNA or RNA or oligonucleotides, antibodies or parts of antibodies, and suitable base, excipient and carrier substances.

[0003] Injection devices are known in the prior art in which a pre-filled syringe is arranged. The pre-filled syringe has an injection needle that is permanently attached to it and through which a drug contained in the pre-filled syringe can be dispensed. To keep the injection needle and the drug in the pre-filled syringe sterile, the injection needle is enclosed by a needle shield attached to the pre-filled syringe and sealed sterilely from the environment. Such needle shields can be designed, for example, as so-called soft needle shields (SNS) or rigid needle shields (RNS). A rigid needle shield (RNS) has several parts, in particular an elastomeric cap-shaped part and a sleeve-shaped part made of a solid, i.e., non-elastomeric, plastic, which receives the elastomeric part and is thus essentially permanently connected to it.

[0004] To inject medication contained in a pre-filled syringe, the needle shield must be removed. From WO2010 / 136076 A1, US 9,339,610 B2, WO 2015 / 144871 A1, and US 2016 / 0243315 A1, it is known that when a cap-shaped puller, also referred to as a cap, is attached to the distal end of the injection device and closes the distal end of the injection device, the needle shield attached to the pre-filled syringe is pulled off along with the cap. The needle shield remains in the cap. For this purpose, the cap has engagement elements that engage with the needle shield when the cap is pulled off. As the puller continues its downward movement, the engagement elements pull the needle shield along with it, thus removing it from the pre-filled syringe.To ensure the needle guard can be safely removed, it is known from the prior art that the engagement elements connected to the cap engage with the needle guard. Furthermore, it is known from EP 2255842 B1 that the needle guard can be removed from the pre-filled syringe by rotating the cap. Further examples from the prior art are known from US 2019 / 001070, US 2015 / 051553, and US 2013 / 274655.

[0005] It is an object of the invention to provide an injection device and a method for preparing such an injection device for administering a product, which allows for easier removal of the needle guard cap from the product container.

[0006] The problem is solved with the injection device according to claim 1. Advantageous further developments result from the dependent claims, the description and the figures.

[0007] The invention relates to a device for administering a product, namely an injection device with a longitudinal axis (L). The injection device can be designed as a so-called autoinjector, which has a mechanism that causes automatic dispensing of the product, e.g., by means of a drive element, in particular a spring, and optionally automatic insertion and / or withdrawal of the injection needle. In an autoinjector, the force for dispensing the product is provided by the drive element, e.g., the spring. Alternatively, the injection device can be designed as a manual injection device, i.e., the force for dispensing the product is provided by muscular force, e.g., by the user.The injection device—whether an autoinjector or a manual injection device—may have a needle guard that, after injection, extends distally beyond the distal end of the injection needle or is moved into this position relative to the device housing to prevent accidental access to the injection needle and thus reduce the risk of injury. Optionally, the needle guard may also extend distally beyond the distal end of the injection needle before injection. In an autoinjector, for example, the needle guard may also serve as a trigger for product dispensing, in which case it is moved proximally relative to the device housing.Alternatively, the autoinjector can be triggered by pressing a trigger button on the autoinjector, with the needle guard sleeve serving as a visual shield before the autoinjector is used.

[0008] The injection device comprises a product container with an injection needle, such as a pre-filled syringe known from the prior art or, more generally, a syringe. The product container can have, for example, a hollow cylindrical section that slidably supports a piston. The piston can form a seal with the inner circumference of the product container section, thus creating a sterile barrier. The piston can be moved distally, for example, by means of a piston rod of the injection device, to dispense product from the product container via the injection needle. The injection needle is preferably permanently attached to the product container. For example, the product container can have a retaining section, in particular a needle retaining section, which is arranged distal to the product container section and is permanently connected to the injection needle, thus surrounding, for example, a proximal part of the injection needle.The injection needle can thus protrude distally from the holding section. The holding section may, for example, have a smaller outer diameter than the product container section. The product container section may taper towards the holding section at its distal end.

[0009] The term "distal" as used herein refers to the direction in which the tip of the injection needle points. The term "proximal" as used herein refers to the direction opposite to the distal direction.

[0010] A needle shield, such as a soft needle shield (SNS) or rigid needle shield (RNS) known from the prior art, is attached to the product container, for example, to the holding section, and is particularly detachably attached. The needle shield can be attached to the holding section, for example, by friction, form-fitting, or a combination of both. The needle shield encloses the injection needle and seals it sterilised from the environment. A soft needle shield (SNS) comprises or consists of an elastomer, for example, a rubber- or latex-based part, which surrounds the needle. The soft needle shield (SNS) has a soft surface on its outer circumference, such as one made of a rubber- or latex-like material. A rigid needle shield (RNS) usually has several parts, in particular an elastomeric cap-shaped inner part and a stiffer, i.e.,A sleeve- or cap-shaped outer part, typically made of non-elastomeric plastic, which receives the elastomeric part and is thus essentially permanently bonded to it. The outer sleeve- or cap-shaped part surrounds the inner cap-shaped part and is permanently bonded to it, for example, so that the outer and inner caps form a single unit. The outer part can be made of a harder plastic than the inner part. For example, the outer part can be made of polyethylene, polystyrene, polypropylene, or another suitable plastic. The inner part can be made of rubber or another suitable material.

[0011] A cap, also known as a closure cap or pull-off cap, may be attached to the distal end of the injection device or housing, such as a receiving housing for the injection device, and may be designed to close the distal end of the housing or receiving housing. The cap may be of one piece or of multiple parts. The injection device may include a housing, such as a receiving housing for the injection device, for receiving the product container, wherein the product container has a permanently attached injection needle and wherein the needle guard cap is detachably arranged on the product container. The needle guard cap encloses the injection needle and provides a sterile seal against the environment. The cap may be connected to the housing or receiving housing and / or to the needle guard sleeve by friction and / or positive locking, such as by snapping.The cap may preferably be made of plastic. Alternatively, the cap may be made of metal. The cap may be removable, for example, during removal from the injection device and / or the housing and / or the needle guard by a combined / serial axial rotational movement or an axial movement from the injection device, such as the housing or receiving housing and / or needle guard.

[0012] The injection device can further comprise a product container holder, which is rigidly connected to the housing of the injection device, in particular axially and rotationally fixed. The product container holder can serve to receive the product container, whereby the product container can be held rigidly, in particular axially and preferably rotationally fixed, within the product container holder. Alternatively, the housing and the product container holder can be formed as a single unit. Alternatively, the product container holder can be arranged to be axially movable and / or rotatable relative to the housing.

[0013] The cap, which is detachably provided at the distal end of the housing or at the distal end of the needle guard sleeve of the injection device, comprises one or more engagement elements to cause the needle guard cap to be removed from the product container when the cap is removed from the injection device. The cap, which is coupled to the engagement element, can be connected to the needle guard cap via the engagement element in such a way that removing the cap from the injection device causes the needle guard cap to be removed from the product container. In particular, at least part or all of the distal movement of the cap can be transmitted to the engagement element, i.e., the engagement element is carried along by the cap, so that the engagement element pulls the needle guard cap away from the product container, especially the retaining section.The cap and / or the engagement element can be rotatably arranged relative to the housing and / or relative to the needle guard sleeve. The engagement element is preferably axially and rotationally fixed to the cap. The cap and the engagement element can be formed in one piece or in multiple parts.

[0014] In one embodiment, the engagement element can be deformable such that it can be moved from a spaced position, in which it is radially spaced from the needle guard, to an engagement position in which it engages with the needle guard, with the engagement element being deformed when the cap is removed. For example, the engagement element can be in the spaced position relative to the needle guard in the delivery state of the injection device. In the engagement position, the engagement element is arranged relative to the needle guard such that a distal movement of the cap causes the needle guard to be carried along with it, thus removing the needle guard from the product container. In the engagement position, the engagement element engages with or into the needle guard.The engagement element can engage on or in a lateral surface, an edge, a distal end face, or a proximal end face of the needle guard cap. The engagement element can comprise one or more hooks. Particularly preferably, the engagement element can be at least partially hook-shaped. Particularly preferably, the engagement element can also be sleeve-shaped or cylindrical. The hook-shaped engagement element can have a short and a long leg. Preferably, the long leg can be deformable. Furthermore, the short leg can be tooth-shaped, triangular, or acute-angled.Alternatively, the engagement element can have a different configuration, wherein in the spaced position of the engagement element the engagement element is radially spaced from the needle guard cap and in the engagement position of the engagement element the engagement element is in engagement with the needle guard cap, wherein the engagement element is deformed during or before the removal of the cap.

[0015] In the spaced position of the engagement element, it can be undeformed, deformed, or radially outwardly deformed. In the engaged position, it can be undeformed, deformed, or radially inwardly deformed. The engagement element can preferably be plastically and / or elastically deformable.

[0016] Plastic deformation refers to permanent deformation. A material is considered plastic if it does not spontaneously return to its original shape. After a force or load is applied, the material retains its shape. Elastic deformation, on the other hand, is reversible. In this case, a material returns to its original shape after a force or load is applied.

[0017] The engagement element is preferably made of metal, in particular steel, and especially preferably stainless steel or spring steel. The engagement element is made of a material that has a flexural strength that allows for plastic and / or elastic deformation. Particularly preferably, the engagement element is designed such that it is plastically and / or elastically deformed in the spaced-away position and remains plastically and / or elastically undeformed in the engagement position, or that it is plastically and / or elastically undeformed in the spaced-away position and plastically and / or elastically deformed in the engagement position.

[0018] Furthermore, one or more locking elements may be provided on the housing or on a part rigidly connected to a housing, wherein, in the engagement position, the locking element(s) engage or engage the engagement element with the needle guard cap. The locking element may 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 may have an inclination. The first and the second inclined surface may be inclined relative to each other.The engagement element of the cap can be coupled to the locking element of the housing in such a way that, during removal of the cap from the injection device, the engagement element is movable relative to the needle guard cap and, during this movement, in particular a combined / serial axial rotation or an axial movement, is deformable by means of the locking element of the housing in such a way that the engagement element, in particular the short leg of the engagement element, can engage with the needle guard cap or engages with it. In the engagement position of the engagement element, the engagement element is axially fixed to the needle guard cap, with the needle guard cap being carried along by the engagement element of the cap during the continuation of the combined / serial axial rotation or the axial movement of the cap.In other words, the stroke that the cap makes when removed from the injection device relative to the housing along the longitudinal axis (L) in the distal direction comprises a first partial stroke during which the cap is movable or is moved relative to the needle guard cap, and a second partial stroke during which the needle guard cap follows the movement of the cap or is carried along by the cap.

[0019] In an alternative embodiment, one or more engagement elements can be provided, which are elastically and / or plastically deformable, wherein the engagement element(s) are always and / or already in contact with the needle guard cap during the assembly of an injection device for administering a product. This assembly method further comprises sliding or inserting a product container with the detachably connected needle guard cap into a housing along a longitudinal axis (L) in the distal direction, the housing having a cap at a distal end. An outer surface of the needle guard cap slides axially over the engagement element(s), in particular the short leg(s) of the engagement element. In the position in which the product container is inserted into the housing, the engagement element(s) of the cap are in an engagement position.In the delivered state of the injection device, the engagement element(s) of the cap can therefore be in an engagement position.

[0020] In an alternative embodiment, the cap can be moved in the proximal direction relative to a needle guard cap using one or more engagement elements in order to place the cap onto a housing that holds a product container.

[0021] The outer surface of the needle guard cap can have one or more openings or one or more fastening means into which the engagement element can engage or bore when in its engagement position. Alternatively, the needle guard cap may have no opening or fastening means, in which case the engagement element can engage or bore into the outer surface of the needle guard cap when in its engagement position.

[0022] Furthermore, the injection device can include an energy storage element. The energy storage element can be held in the cap by one or more retaining elements, so that the energy storage element does not fall out of the cap.

[0023] At least partial removal of the needle guard cap from the product container is defined as a combination of manual removal, i.e., where the force for removal is provided by muscle power, such as by the user, and automatic removal, i.e., where the force for removal is provided by an energy storage element, such as a spring or a magnet. The energy storage element can assist in the manual removal of the needle guard cap from the product container.

[0024] The energy storage element can be supported in the distal direction on the cap and in the proximal direction on the housing or on the needle guard sleeve.

[0025] The cap can be rotated relative to the housing and / or the needle guard sleeve. This relative rotation can be used to remove the cap from the injection device. The relative rotation can either remove the cap or allow it to be removed.

[0026] Furthermore, an element can be provided on the housing of the injection device or on the needle guard sleeve, which engages in a guiding manner with a counter element provided on the cap. The element and / or the counter element can be designed as a guide track / groove or a guide cam. Preferably, the guide track / groove can include a thread or be threaded. Alternatively, the guide track / groove can include a step or a staircase, or be stepped or L-shaped.

[0027] The guide track / groove can preferably include a step or a staircase. The step or staircase can serve to brake the element or counter-element during its guidance through the step or staircase. This prevents uncontrolled removal of the cap from the injection device.

[0028] The element is particularly preferably connected to the housing or needle guard sleeve in an axially and rotationally fixed manner. Furthermore, the mating element can be connected to the cap in an axially and rotationally fixed manner. The element and the housing or needle guard sleeve can also be formed in one or more parts. Finally, the mating element and the cap can also be formed in one or more parts.

[0029] The cap can be rotatable relative to the housing or relative to the needle guard sleeve to remove it from the injection device. Preferably, the element and the counter-element can be rotatable relative to each other. The element and the counter-element can be configured to prevent removal of the cap from the injection device in a first relative rotational position about the longitudinal axis (L) between the element and the counter-element, and to enable removal of the cap from the injection device in a second relative rotational position about the longitudinal axis (L) between the element and the counter-element. Thus, the cap can be removed from the injection device in a controlled manner, and not unintentionally, particularly with the assistance of the energy storage element, and especially with the assistance of the force provided by the energy storage element.

[0030] Particularly preferably, the element or the counter-element can serve as a support element for the energy storage element in the proximal direction. This allows the injection device to be designed compactly.

[0031] The element and / or the counter-element can preferably be made of plastic. Alternatively, the element and / or counter-element can be made of metal.

[0032] According to the invention, the element, housing, or needle guard sleeve has a back-rotation locking element, and the counter element or cap has a back-rotation locking counter element to allow rotation of the cap about the longitudinal axis (L) in one direction and to block rotation in the opposite direction. The back-rotation mechanism of the injection device ensures that the user can only rotate the cap in one direction relative to the engagement element, the housing, or the needle guard sleeve. Rotation of the cap about the longitudinal axis (L) is possible in one direction and blocked in the opposite direction.

[0033] Preferably, the anti-rotation element and / or the anti-rotation counter-element can have teeth or a detent, or be designed as teeth or a detent. For this purpose, the anti-rotation element can have one or more teeth which interact with one or more teeth of the anti-rotation counter-element such that rotation of the cap about the longitudinal axis (L) is possible in one direction and blocked in the opposite direction. The corresponding teeth or detent comprise corresponding sliding surfaces and stop surfaces to allow rotation of the cap about the longitudinal axis (L) in one direction and block it in the opposite direction.

[0034] In an alternative embodiment, the anti-rotation element and / or the anti-rotation counter element can have a spring arm or be designed as a spring arm. Furthermore, the anti-rotation element and / or the anti-rotation counter element can have a projection, shoulder, recess, groove, or notch that is open in one direction around the longitudinal axis (L) and locked in the opposite direction.

[0035] Alternative designs of the anti-rotation element and / or the anti-rotation counter element may be provided, insofar as rotation about the longitudinal axis (L) is possible in one direction and is blocked in the opposite direction.

[0036] Furthermore, the injection device, in particular the cap, the engagement element and / or the housing, may have visual markings, especially in the form of a symbol, particularly preferably in the form of an arrow, to indicate the direction in which the cap can be rotated relative to the housing or the needle guard sleeve about the longitudinal axis (L). These markings facilitate the operation of the injection device. In alternative embodiments, acoustic and / or tactile markings may be provided additionally or alternatively.

[0037] The needle guard is preferably provided on or in the injection device, with the cap being detachably connected to the housing via the needle guard. The needle guard is preferably arranged to be rotationally fixed relative to the housing. The needle guard serves to protrude distally beyond the distal end of the injection needle before or after injection. The needle guard is partially enclosed by the housing, and the cap can be placed on one distal end of the needle guard. The cap can be connected to the needle guard, for example, by friction and / or positive locking, such as by snapping. Alternatively, the cap can be detachably connected to the housing, and the injection device may or may not include a needle guard.

[0038] Reference is also made to the features disclosed in connection with the device described herein, which also advantageously further develop the method. Figure 1 shows an exploded view of a distal end of a first embodiment of an injection device according to the invention with a longitudinal axis (L). Figure 2 shows a longitudinal sectional view of the injection device according to the invention. Figure 1 , wherein the cap (1) is arranged in a first relative rotational position relative to the needle guard sleeve (3). Figure 3 is a perspective view of the Figure 2 , wherein part of the cap (1) is recessed. Figure 4 shows a perspective view of the injection device according to Figure 1 , wherein a part of the cap (1) is recessed and wherein the cap (1) is arranged in a second relative rotational position relative to the needle guard sleeve (3). Figure 5 shows a longitudinal sectional view of the cap (1) according to Figure 1, wherein the cap (1) is removed from the injection device and holds the needle guard cap (5a). Figure 6 is an exploded view of a distal end of a second embodiment of an injection device according to the invention with a longitudinal axis (L). Figure 7 is a longitudinal sectional view of the injection device according to Figure 6 , wherein the cap (1c, 1d) is arranged in a first relative rotational position relative to the housing (4'). Figure 8 shows a longitudinal sectional view of the cap (1c, 1d) according to Figure 6 , wherein the cap (1c, 1d) is removed from the injection device and holds the needle guard cap (5a). Figure 9 is a perspective view of the Figure 8 , where the needle guard (5a') and the spring are not shown. Figure 10 is a longitudinal sectional view of the injection device according to Figure 6 , wherein the cap (1c, 1d) has been removed from the injection device and is therefore not visible.

[0039] In the Figure 1An exploded view of a first embodiment of an injection device according to the invention is shown, wherein a cap (1) is detachably arranged on the injection device. For example, in its delivered state, the injection device may have the cap (1) attached to its distal end. The injection device comprises a housing (4). The housing (4) can be designed as a sleeve-shaped, in particular cylindrical, receiving housing with a distal and a proximal part. The housing (4) serves to receive a product container (5). The product container (5) has a permanently attached injection needle ( Figure 2 ; 5b) wherein a needle protection cap (5a) is detachably arranged on the product container (5), which protects the injection needle ( Figure 2; 5b) encloses and seals sterilely against the environment. The injection device further comprises a needle guard sleeve (3). The needle guard sleeve (3) can be displaceable in the proximal direction relative to the housing (4) of the injection device to trigger product dispensing. The needle guard sleeve (3) is preferably rotationally fixed to the housing (4). After product dispensing, the needle guard sleeve (3) can be displaced in the distal direction relative to the housing (4) to protect the tip of the injection needle ( Figure 2; 5b) to cover in order to reduce the risk of injury. The cap (1) comprises one or more engagement elements (1a). The engagement element (1a) serves to facilitate the removal of the needle guard cap (5a) from the product container (5) when the cap (1) is removed from the injection device. For this purpose, the engagement element (1a) is hook-shaped or has one or more hooks. The hook is designed such that it can engage with or on the needle guard cap (5a) in order to be in or reach an engagement position with the needle guard cap (5a). The engagement element (1a) is preferably made of metal, in particular steel, and more preferably stainless steel or spring steel. Alternatively, the engagement element (1a) can be made of plastic. The engagement element (1a) is preferably axially and rotationally fixed to the cap (1). The cap (1) is preferably made of plastic.Alternatively, the cap (1) and the engagement element (1a) can be formed in one piece and are preferably made of metal, in particular steel, and especially preferably of stainless steel or spring steel. The cap (1) is preferably detachably provided at the distal end of the housing (4) via the needle guard sleeve (3). Alternatively or additionally, the cap (1) can be detachably provided directly at the distal end of the housing (4). The injection device further comprises an energy storage element (2) in the form of a spring (2). The spring (2) is supported distally on the cap (1) and proximally on the needle guard sleeve (3). Alternatively, the spring (2) can be supported proximally on the housing (4). The spring (2) is pre-tensioned in the injection device such that the needle guard cap (5a) can be at least partially removed from the product container (5) by a force exerted by the spring (2).The spring (2) is at least partially attached to the cap (1). An element (3a) is provided on the needle guard sleeve (3) or alternatively on the housing (4) of the injection device, which engages in a guide engagement with a counter element provided on the cap (1). Figure 3 ; 1b). The element (3a) and / or the counterpart element ( Figure 3 ; 1b) can be designed as a guide track / guide groove or a guide cam. The cap (1) is rotatably arranged relative to the housing (4) or the needle guard sleeve (3) in order to remove the cap (1) from the injection device. The element (3a) and the counter element ( Figure 3 ; 1b) can be rotatable relative to each other. The element (3a) and the counter-element ( Figure 3 ; 1b) are designed to be in a first relative rotational position about the longitudinal axis (L) between the element (3a) and the counter element ( Figure 3; 1b) to prevent the cap (1) from being removed from the injection device and to position it in a second relative rotational position about the longitudinal axis (L) between the element (3a) and the counter element ( Figure 3 ; 1b) to allow the cap (1) to be removed or pulled off the injection device. Thus, the cap (1) can be removed from the injection device by means of the force of the spring (2).

[0040] In the Figure 2 is a longitudinal sectional view of the injection device according to Figure 1The cap (1) is arranged in a first relative rotational position relative to the needle guard (3). The engagement element (1a) of the cap is in the engagement position. The engagement element (1a), in particular a short leg of the engagement element (1a), engages the edge of the needle guard cap (5a). The spring (2) is pre-tensioned in the distal direction against the cap (1) and in the proximal direction against the needle guard (3). Furthermore, the cap (1) is connected to the housing (4) of the injection device via a detachable connection, in particular via the needle guard (3). Furthermore, the element (3a) of the needle guard (3) and the counter element (1b) of the cap (1) are in a guiding engagement. The element (3a) of the needle guard (3) and the counter element (1b) of the cap (1) are in the first relative rotational position, as shown in the Figure 3As can be seen, the element (3a) of the needle guard sleeve (3) and the counter element (1b) of the cap (1) are arranged relative to each other in the first relative rotational position such that removal of the cap (1) from the injection device is prevented. In this embodiment, the element (3a) of the needle guard sleeve (3) is designed as a guide track / guide groove, in particular L-shaped, and the counter element (1b) of the cap (1) is designed as a cam. Other configurations of the element (3a) and the counter element (1b) are possible. Furthermore, the guide track / guide groove can include a step or a staircase. The step or staircase can serve to brake the counter element (1a), designed as a cam, during its guidance in the element (3a), which is designed as a guide track / guide groove.

[0041] To remove the cap (1) from the injection device, the user rotates the cap (1) about its longitudinal axis (L) relative to the housing (4) and / or the needle guard sleeve (3). A visual marking, in particular a symbol, may be provided on the injection device to indicate the direction in which the cap (1) can be rotated relative to the housing (4) and / or the needle guard sleeve (3) about its longitudinal axis (L). During this rotation, the counter element (1b) of the cap (1) moves relative to the element (3a) of the needle guard sleeve (3) from its first relative rotation position to a second relative rotation position. In the second relative rotation position, the counter element (1b) of the cap (1) and the element (3a) of the needle guard sleeve are arranged relative to each other such that the cap (1) can be removed from the injection device, as shown in the diagram. Figure 4 is shown.

[0042] The cap (1) can be removed from the injection device by a combined / serial axial rotation or axial movement of the cap (1) relative to the housing (4) and / or the needle guard sleeve (3). During this movement, the engagement element (1a) of the cap (1) can be moved distally. The engagement element (1a) of the cap (1) can be moved distally simultaneously or subsequently. The engagement element (1a) of the cap (1) is or is brought into engagement with the needle guard cap (5a). Particularly preferably, the engagement element (1a), especially the short leg of the engagement element (1a), engages the edge of the needle guard cap (5a). The axial movement of the engagement element (1a) is assisted by the spring (2). During this movement, the spring (2) relaxes at least partially, and the force of the spring (2) assists at least partially in the manual removal of the needle guard cap (5a) from the product container (5).

[0043] Removing the cap (1) from the injection device causes the needle guard cap (5a) to be removed from the product container (5). After the cap (1) is removed from the injection device, the needle guard cap (5a) remains in the cap (1). The needle guard cap (5a) is held in the cap (1), in particular by the engagement element (1a), as shown in the Figure 5 This is shown. Afterwards, the user can administer an injection using the injection device.

[0044] In the Figure 6Figure 1 shows an exploded view of a second embodiment of an injection device according to the invention. This injection device differs from the injection device of the first embodiment essentially only in its design and in the interaction of the cap (1c, 1d), the needle guard sleeve (3'), the spring (2'), and the housing (4'). In this embodiment, the cap (1c, 1d) is designed in two parts for injection molding reasons, namely a first part (1c) and a second part (1d), although a one-piece cap (1c, 1d) is also possible.

[0045] In the Figure 7 is a longitudinal sectional view of the injection device according to Figure 6The embodiment is shown, wherein the cap (1c, 1d) is arranged in a first relative rotational position relative to the housing (4'). An engagement element (1a') is in the engagement position, with the engagement element (1a') engaging the edge of a needle guard cap (5a') arranged on a product container (5'). The needle guard cap (5a') surrounds an injection needle (5b') of the product container (5'). Furthermore, in this embodiment, the product container (5') is axially and rotationally fixed in a product container holder (5c), which is axially and rotationally fixed in the housing (5'). The spring (2') is supported with preload in the distal direction on the cap (1c, 1d) and in the proximal direction on the housing (4'). The spring (2') is held in the cap (1) by one or more retaining elements. The element designed as a cam ( Figure 10 ; 4a) of the housing (4') is in guide engagement with the counter element designed as a guide track / guide groove ( Figure 9 ; 1b') of the cap (1c, 1d). The element (4a) of the housing (4') and the counter element ( Figure 9 ; 1b') of the cap (1c, 1d) are arranged relative to each other in the first relative rotation position such that removal of the cap (1c, 1d) from the injection device is prevented. The guide track of the counter element ( Figure 9 ; 1b') of the cap (1c, 1d) is designed in a stepped form in this embodiment. The step can serve to ensure that the cam-shaped element (4a) of the housing is guided in the counter-element designed as a guide track / guide groove / step groove ( Figure 9 ; 1b') of the cap (1c, 1d) is braked. The element designed as a cam is particularly preferred ( Figure 10 ; 4a) of the housing (4) serve as a support element for the spring (2') in the proximal direction.

[0046] To remove the cap (1c, 1d) from the injection device, the user rotates the cap (1c, 1d) about its longitudinal axis (L) relative to the housing (4') and / or the needle guard sleeve (3'). As this happens, the counter element (1b') of the cap (1c, 1d) moves relative to the element ( Figure 10 ; 4a) of the housing (4') from the first relative rotational position to a second relative rotational position. During this movement, the cam-shaped element slides ( Figure 10 ; 4a) of the housing (4') along the counter element designed as a staircase ( Figure 9 ; 1b') of the cap (1c, 1d). The counter-element designed as a staircase ( Figure 9 ; 1b') of the cap (1c, 1d) slows down the movement of the cam-shaped element ( Figure 10; 4a) of the housing (4'). In the second relative rotation position, the counter element (1b') of the cap (1c, 1d) and the element (4a) of the housing (4') are arranged relative to each other in such a way that it is possible to remove the cap (1c, 1d) from the injection device.

[0047] By a combined axial-rotational movement or an axial movement of the cap (1c, 1d) relative to the housing (4') and / or the needle guard (3'), the cap (1c, 1d) can be removed from the injection device, whereby the engagement element (1a') of the cap (1c, 1d) engages the edge of the needle guard (5a') and takes the needle guard (5a') with it. After removing the needle guard (5a') from the product container (5'), the user can administer an injection using the injection device. Reference symbol:

[0048] 1 Cap 1a, 1a' Engagement element 1b, 1b' Counter element 1c first part of cap 1d second part of cap 2, 2' Energy storage element, spring 3, 3' Needle guard sleeve 3a Element of needle guard sleeve 4, 4' Housing 4a Element of housing 5, 5' Product container 5a, 5a' Needle guard cap 5b, 5b' Injection needle 5c Product container holder L Longitudinal axis

Claims

1. Injection device of my longitudinal axis (L), comprising: - a housing (4; 4') for receiving a product container (5; 5'), the product container (5; 5') having a fixedly connected injection needle (5b; 5b'), a needle protection cap (5a; 5a') being detachably arranged on the product container (5; 5'), which needle protection cap encloses the injection needle (5b; 5b') and seals the injection needle from the surroundings in a sterile manner, - a cap (1; 1c, 1d) detachably provided at a distal end of the housing (4; 4'), the cap (1; 1c, 1d) comprising an engagement element (1a; 1a') to remove the needle protection cap (5a; 5a') from the product container (5; 5') when the cap is removed from the injection device, - an energy storage element (2, 2') for at least partially removing the needle protection cap (5a, 5a') from the product container (5; 5'), which energy storage element is supported in the distal direction on the cap (1; 1c, 1d) and in the proximal direction on the housing (4; 4') or is supported on a needle protection sleeve (3; 3') axially movably arranged on the housing (4, 4') and projecting distally over the distal end of the injection needle (5b; 5b') after injection, - the cap (1; 1c, 1d) being rotatable relative to the housing (4; 4') and / or relative to the needle protection cap (5a; 5a'), - an element (3a; 4a) which is provided on the housing (4) or on the needle protection sleeve (3) and guidingly engages with a counter element (1b; 1b') provided on the cap (1; 1c, 1d), the element (3a; 4a) and the counter element (1b; 1b') being designed to prevent the cap (1; 1c, 1d) from being removed from the injection device in a first relative rotational position about the longitudinal axis (L) between the element (3a; 4a) and the counter element (1b; 1b') and to allow the cap (1; 1c, 1d) to be removed from the injection device in a second relative rotational position about the longitudinal axis (L) between the element (3a; 4a) and the counter element (1b; 1b'), characterized in that the element (3a; 4a) or the housing (4) has an anti-reverse-rotation element and the counter element (1b; 1b') or the cap (1; 1c, 1d) has an anti-reverse-rotation counter element, to allow rotation of the cap (1; 1c, 1d) about the longitudinal axis (L) in one direction and to block it in the opposite direction.

2. Injection device according to claim 1, characterized in that the element (3a; 4a) and / or the counter element (1b; 1b') is in the form of a guide slot / guide groove or a guide cam.

3. Injection device according to claim 2, characterized in that the guide slot / guide groove comprises a thread or is thread-shaped.

4. Injection device according to claim 2 or 3, characterized in that the guide slot / guide groove comprises a shoulder or a step or is stepped or L-shaped.

5. Injection device according to any of the preceding claims, characterized in that the energy storage element (2; 2') is in the form of a spring (2; 2') or a magnet.

6. Injection device according to any of the preceding claims, characterized in that the element (4a) or the counter element serves as a support element for the energy storage element (2') in the proximal direction.

7. Injection device according to any of the preceding claims, characterized in that the engagement element (1a; 1a') is connected to the cap (1; 1c, 1d) in an axially fixed manner for conjoint rotation.

8. Injection device according to any of the preceding claims, characterized in that the element (3a; 4a) is connected to the housing (4; 4') or the needle protection sleeve (3, 3') in an axially fixed manner for conjoint rotation and the counter element (1b; 1b') is connected to the cap (1; 1c, 1d) in an axially fixed manner for conjoint rotation.

9. Injection device according to any of the preceding claims, characterized in that the injection device has a visual marking, in particular in the form of a symbol, to indicate in which direction a relative rotation of the cap (1; 1c, 1d) with respect to the housing (4; 4') or to the needle protection sleeve (3; 3') about the longitudinal axis (L) is possible.

10. Injection device according to any of the preceding claims, characterized in that the engagement element (1b; 1b') has one or more hooks or is hook-shaped.

11. Injection device according to any of the preceding claims, characterized in that the engagement element (1b; 1b') is elastically or plastically deformable.

12. Injection device according to any of the preceding claims, characterized in that a needle protection sleeve (3; 3') is provided, the cap (1; 1c, 1d) being detachably provided with the housing (4; 4') via the needle protection sleeve (3; 3').