Patent Description:
In order to protect the needle of an injection device such as an autoinjector, needle shields are known from the state of the art. It is also known to cover such needle shields with caps that mechanically protect the needle shield and the needle and that ease the removal of the needle shield from the needle in preparation of an injection.

Document <CIT> describes an apparatus for removal of a boot that provides a sterile cover for a prefilled syringe. The apparatus comprises a housing with an opening for receiving a boot attached to a pre-filled syringe, a plurality of fingers arranged within the housing and being deflectable in a radial direction by the boot when the boot is inserted into the hosing. The fingers provide at their ends formations for snapping into a channel formed at the junction of the boot and a shoulder of the syringe. A collar is arranged to slide over the fingers between a first and a second position. In the first position are free to deflect, whereas in the second position a deflection of the fingers is prevented.

Document <CIT> discloses a cap connectable with a boot covering a needle of a syringe housed in an injection device. The cap has grip means formed as a pair of arms with a hook means. The syringe boot may be received between the arms and the hook means grip at the open end of the boot. A ring shaped retention means has a groove on its inner surface. The arms of the grip means have a corresponding ridge. The ridge and the groove interlock to clamp the arms together and thereby clamp the cap into the syringe boot. The ring shaped retention means may have feet that extend through the closed end of the cap and that can be depressed to disengage the ring from the arms and allow them to splay out releasing the boot.

<CIT> discloses a manual drive unit for use with a cassette unit comprising a cassette unit housing containing there within a syringe comprising a barrel; a hollow needle at a front end of said barrel; and a plunger that is axially movable within the barrel.

An object of the present disclosure is to provide an improved assembly of a cap on a needle shield and an improved method of mounting a cap on a needle shield, in particularity as to reduce the amount of force required to exert on a needle shield when mounting the cap. A further object of the present disclosure is to provide an assembly of a cap on a needle shield and a method of mounting a cap on a needle shield with an improved platform flexibility,
wherein one cap can fit a multitude of needle shields.

The object of the invention is achieved by a cap assembly according to independent claim <NUM> and by a method for assembling a cap assembly according to independent claim <NUM>.

Exemplary embodiments are provided in the dependent claims.

In the context of this specification, the terms distal and proximal are defined from the point of view of a person performing an injection. Consequently, a distal direction refers to a direction pointing towards the site of an injection and a distal end defines an end of an element that is directed towards the site of the injection. Respectively, the proximal end of an element or the proximal direction is directed away from the site of the injection and opposite to the distal end or distal direction.

According to the invention, a cap assembly for covering a needle shield of an injection device comprises at least a collar and a cap with a sheath and a bottom. The sheath substantially extends along a central longitudinal axis directed in a longitudinal direction from the proximal towards the distal end of the cap. On its proximal end, the cap has an opening aligned with the sheath. The distal end of the cap is at least partially closed by a bottom. The collar is movable relative to the sheath along the longitudinal direction. When moving the sheath relative to the collar, the collar is moved from an unlocked position into a locked position. In its unlocked position, the collar does not engage the needle shield or the sheath. In its locked position, the collar force-lockingly engages the sheath and thereby locks the sheath to the needle shield.

As an advantage, the needle shield is locked to the cap by moving the collar instead of moving the needle shield relative to the cap. In other words, the cap may be mounted onto the needle shield with substantially reduced or no force exerted on the needle shield while the needle shield is moved relative to the cap, thereby reducing the risk of damaging the needle or impacting sterility. Further, the needle shield is being removable upon removal of the cap.

In an embodiment of the cap assembly useful for understanding the invention, the sheath is formed by radially deflectable arms proximally extending from the bottom. On the proximal ends of the radially deflectable arms, clips protrude radially inwardly towards the central longitudinal axis. The clips are adapted to be received by corresponding recesses in the outer surface of the needle shield. The collar circumferentially encloses the radially deflectable arms. In its unlocked position, the collar is sled towards the bottom of the cap. In its locked position, the collar is sled towards the proximal end of the cap such that the clips are form-fittingly held in the corresponding recesses. The collar may be held force-lockingly by friction, e.g. by an interference rib or a press fit, in its locked position.

By forcing apart the radially deflectable arms, the distal end of the needle shield can be introduced into the sheath formed by the radially deflectable arms without force. Once the clips face their corresponding recesses, the radially deflectable arms are released such that the clips form-fittingly engage the recesses. By sliding the collar proximally into its locked position, the collar engages the radially deflectable arms, thereby pressing the clips on the distal ends into the recesses. No force is exerted upon the needle shield along the longitudinal direction, thereby minimising the risk of damaging the needle or loosening the needle shield or compromising sterility.

In an embodiment of the cap assembly useful for understanding the invention, the clips are formed as catches pointing towards the proximal ends of the radially deflectable arms. In this embodiment, it is particularly easy to bring the clips into engagement with the recesses, as the catches snap into the recesses when the needle shield is introduced into the cap.

In an embodiment of the cap assembly useful for understanding the invention, the sheath is formed as a rigid tube circumferentially enclosing the collar. The rigid tube is adapted to receive the needle shield with a tubular, proximally narrowing clearance. In its unlocked position at the distal end of the rigid tube, the collar engages neither the rigid tube nor the needle shield. When moved proximally within the proximally narrowing clearance the collar reaches its locked position, where it force-lockingly engages the needle shield and the sheath, thereby locking the needle shield to the cap. As the needle shield needs not be moved relative to the cap when locked to the cap, the needle is protected during the assembling.

According to the invention, the sheath is formed as a rigid tube. The rigid tube is adapted to receive the collar loosely enclosing the needle shield in its unlocked position, wherein the collar is radially compressible. The collar is formed as a conical neck narrowing towards its distal end such that the collar is compressed by the sheath and force-lockingly engages the needle shield in its locked position when the sheath is moved proximally.

As an advantage, no force is exerted upon the needle shield along the longitudinal direction when locking the cap to the needle shield. As a further advantage, the collar may be pre-assembled to a case encasing the injection device with the needle protected by the needle shield. It is, however, also possible to pre-assemble the collar to the cap according to this embodiment. Thereby, the flexibility in manufacturing is improved.

In an embodiment of the cap assembly, the needle shield is formed as a rigid needle shield being made of a substantially rigid material. In another embodiment of the cap assembly, the needle shield is formed as a flexible needle shield being made of a flexible material such as rubber.

According to an embodiment useful for understanding the invention, a method for assembling a cap assembly with a cap with a sheath formed by radially deflectable arms comprises the steps of.

As an advantage, according to this method, a cap assembly can be assembled without exerting force in the longitudinal direction upon the needle shield, thereby protecting the needle and improving sterility.

According to an embodiment useful for understanding the invention, a method for assembling a cap assembly with a cap with a sheath formed as a rigid tube circumferentially enclosing the collar and adapted to receive the needle shield with a tubular, proximally narrowing clearance comprises the steps of.

As an advantage, according to this method, the needle shield is held by the cap when being locked to the cap, thereby protecting the needle and improving sterility. Further, the friction force will cause the collar to grip harder as the needle shield is removed from the needle during cap removal. As a further advantage, the one cap can fit a multitude of needle shields by adjustment of the collar, resulting in an improved platform flexibility.

According to the invention, a method for assembling a cap assembly with a cap with a sheath formed as a rigid tube adapted to receive the collar circumferentially enclosing the needle shield, wherein the collar is formed as a conical neck narrowing towards its distal end, comprises the steps of.

As an advantage, according to this method, a cap assembly can be assembled without exerting force in the longitudinal direction upon the needle shield, thereby protecting the needle. As a further advantage, such a method is applicable to collars that are pre-assembled to a case encasing the injection device with the needle protected by the needle shield as well as to collars that are pre-assembled to a cap that is to be mounted onto such a needle shield. Thereby, the flexibility in manufacturing such cap assemblies is improved.

Further scope of applicability of the present invention will become apparent from the detailed description given hereinafter. However, it should be understood that the detailed description and specific examples, while indicating exemplary embodiments of the invention, are given by way of illustration only, since various changes and modifications within the scope of the invention will become apparent to those skilled in the art from this detailed description.

The present disclosure will become more fully understood from the detailed description given below and the accompanying drawings, which are given by way of illustration only, and do not limit the present disclosure, and wherein:.

<FIG> show an embodiment of an exemplary cap assembly with a collar <NUM> assembled to a cap <NUM>. The cap <NUM> has an inner sheath that is formed by at least two radially deflectable arms <NUM>. The cap <NUM> may be moulded, wherein the radially deflectable arms <NUM> are moulded such that the inner sheath narrows towards a proximal end P of the cap <NUM>, as shown in <FIG>.

On their proximal ends, the radially deflectable arms <NUM> provide clips <NUM>. <NUM> that radially inwardly protrude towards a central longitudinal axis A of the cap assembly. The clips <NUM>. <NUM> may be formed as catches pointing towards the proximal end P, but other profiles adapted to form-fittingly lock with corresponding recesses are possible for the clips <NUM>. <NUM> as well.

The cap <NUM> has a bottom <NUM> on a distal end D. The collar <NUM> is assembled to the cap <NUM> such that it circumferentially encloses the radially deflectable arms <NUM>. The collar <NUM> is assembled in an unlocked position U at the bottom <NUM> of the cap <NUM>. It is also possible that the collar <NUM> is slid over the radially deflectable arms <NUM> towards its unlocked position U at the bottom <NUM> in a preparatory step of the assembling of the cap assembly.

<FIG> shows the cap <NUM> with the radially deflectable arms <NUM> forced apart radially outwardly in a subsequent step of assembling, thereby opening a circular clearance around the central longitudinal axis A. The circular clearance is adapted to receive the distal end of a rigid needle shield <NUM> covering a needle <NUM> of an injection device such as an autoinjector.

As shown in <FIG>, such a rigid needle shield <NUM> is introduced into the opening enclosed by the radially outwardly forced apart radially deflectable arms <NUM>. The needle shield <NUM> is substantially conically narrowing towards its distal end such that it can be introduced into the cap <NUM> without application of force. The needle shield <NUM> provides recesses <NUM> in its mantle surface that are formed such that they can form-fittingly receive the clips <NUM>. <NUM> of the radially deflectable arms <NUM>.

Once the recesses <NUM> face the corresponding clips <NUM>. <NUM>, the radially deflectable arms <NUM> are released, such that the clips <NUM>. <NUM> form-fittingly engage the corresponding recesses <NUM>. The recesses <NUM> are formed into the mantle surface of the needle shield <NUM> such that the radially deflectable arms <NUM> are slightly spread radially outwardly on their proximal ends. Therefore, when the collar <NUM> is moved towards the proximal end P of the cap <NUM> into a locked position L, it force-lockingly engages the radially deflectable arms <NUM> by friction. The collar <NUM> is thereby prevented from sliding back towards the bottom <NUM> of the cap <NUM> and the clips <NUM>. <NUM> are locked into the corresponding recesses <NUM>, thereby locking the needle shield <NUM> to the cap <NUM>. Thus, upon pulling the cap <NUM> in a distal direction, the needle shield <NUM> is removed from the needle <NUM>.

<FIG> show a further example of a cap assembly with a collar <NUM> assembled to a cap <NUM>. The cap <NUM> has an inner sheath formed as a cylindrical rigid tube <NUM> with a radially inwardly protruding stop <NUM>. <NUM> on its proximal end P. The radially inwardly protruding stop <NUM>. <NUM> may be formed as a circumferential flange, yet other embodiments such as inwardly protruding ribs are possible as well. The collar <NUM> is led inside the rigid tube <NUM> along the central longitudinal axis A, wherein the stop <NUM>. <NUM> prevents the collar <NUM> to leave the tube <NUM> on the proximal end P. Upon assembling the cap assembly, the collar <NUM> is in its unlocked position U on the distal end D of the rigid tube <NUM>.

The stop <NUM>. <NUM> is formed as to receive a conically narrowing distal end of the needle shield <NUM>, as shown in <FIG>. In a first assembling step, the needle shield <NUM> is introduced into the rigid tube <NUM> in a distal direction, until the stop <NUM>. <NUM> engages the needle shield <NUM>. A gap opens between the conical mantle surface of the needle shield <NUM> and the cylindrical inner surface of the rigid tube <NUM>, wherein the clearance of this gap is sufficient to receive the collar <NUM> on the distal end, yet tighter than the collar <NUM> on the proximal end. In a second assembling step, the collar <NUM> is sled in a proximal direction along the central longitudinal axis A until it force-lockingly engages the needle shield <NUM> and the inner surface of the rigid tube <NUM> in a locked position L, thereby locking the needle shield <NUM> to the cap <NUM>. Thus, upon pulling the cap <NUM> in a distal direction, the needle shield <NUM> is removed from the needle <NUM>.

<FIG> show an embodiment of a cap assembly according to the invention with a collar <NUM> assembled to a case <NUM> of an injection device such as an auto-injector. The collar <NUM> encloses a needle shield <NUM>. The collar <NUM> is assembled to the distal end of the case <NUM> by means of a releasable holding <NUM>. The collar <NUM> is formed as a conical neck with a wedge-shaped cross-section that narrows in the distal direction. The collar <NUM> is formed such that it can be compressed radially. For example, the collar <NUM> may be made from an elastic material such as rubber, wherein the compression is achieved using a tool inserted from the open end of the cap <NUM>. The cap <NUM> may, for example, provide a small undercut and/or a rough surface finish in its side wall that, together with radial pressure caused by an axial compression, effects to hold the collar <NUM> in its position. In its unlocked position U, the collar <NUM> in its uncompressed state does not engage the needle shield <NUM>.

The cap <NUM> has an inner sheath formed as a cylindrical rigid tube <NUM> and a bottom <NUM> on its distal end D. The bottom <NUM> may have a central opening aligned with the rigid tube <NUM>, such that the rigid tube <NUM> is open on its distal end. The bottom <NUM> may also be formed as a continuous surface closing the cap <NUM> and the rigid tube <NUM> on the distal end D of the cap <NUM>. The clearance of the rigid tube <NUM> is sufficient to receive the distal end of the collar <NUM> circumferentially enclosing the needle shield <NUM>, as shown in <FIG>. By sliding the cap <NUM> over the collar <NUM> in a proximal direction, the collar <NUM> is radially inwardly compressed due to its wedge-shaped profile, causing the releasable holding <NUM> to release the collar <NUM> from the case <NUM> such that it moves into its locked position L. In its locked position L, the compressed collar <NUM> force-lockingly engages the needle shield <NUM> and the inner surface of the rigid tube <NUM>, thereby locking the needle shield <NUM> to the cap <NUM>. Thus, upon pulling the cap <NUM> in a distal direction, the needle shield <NUM> is removed from the needle <NUM>.

Exemplary insulin derivatives are, for example, B29-N-myristoyl-des(B30) human insulin; B29-N-palmitoyl-des(B30) human insulin; B29-N-myristoyl human insulin; B29-N-palmitoyl human insulin; B28-N-myristoyl LysB28ProB29 human insulin; B28-N-palmitoyl-LysB28ProB29 human insulin; B30-N-myristoyl-ThrB29LysB30 human insulin; B30-N-palmitoyl- ThrB29LysB30 human insulin; B29-N-(N-palmitoyl-gamma-glutamyl)-des(B30) human insulin; B29-N-(N-lithocholyl-gamma-glutamyl)-des(B30) human insulin; B29-N-(ω-carboxyheptadecanoyl)-des(B30) human insulin and B29-N-(ω-carboxyheptadecanoyl) human insulin. Exemplary GLP-<NUM>, GLP-<NUM> analogues and GLP-<NUM> receptor agonists are, for example: Lixisenatide / AVE0010 / ZP10 / Lyxumia, Exenatide / Exendin-<NUM> / Byetta / Bydureon / ITCA <NUM> / AC-<NUM> (a <NUM> amino acid peptide which is produced by the salivary glands of the Gila monster), Liraglutide / Victoza, Semaglutide, Taspoglutide, Syncria / Albiglutide, Dulaglutide, rExendin-<NUM>, CJC-<NUM>-PC, PB-<NUM>, TTP-<NUM>, Langlenatide / HM-11260C, CM-<NUM>, GLP-<NUM> Eligen, ORMD-<NUM>, NN-<NUM>, NN-<NUM>, NN-<NUM>, Nodexen, Viador-GLP-<NUM>, CVX-<NUM>, ZYOG-<NUM>, ZYD-<NUM>, GSK-<NUM>, DA-<NUM>, MAR-<NUM>, MAR709, ZP-<NUM>, ZP-<NUM>, TT-<NUM>, BHM-<NUM>. MOD-<NUM>, CAM-<NUM>, DA-<NUM>, ARI-<NUM>, ARI-<NUM>, Exenatide-XTEN and Glucagon-Xten.

Basic salts are e.g. salts having a cation selected from an alkali or alkaline earth metal, e.g. Na+, or K+, or Ca2+, or an ammonium ion N+(R1)(R2)(R3)(R4), wherein R1 to R4 independently of each other mean: hydrogen, an optionally substituted C1-C6-alkyl group, an optionally substituted C2-C6-alkenyl group, an optionally substituted C6-C10-aryl group, or an optionally substituted C6-C10-heteroaryl group.

Claim 1:
A cap assembly for covering a needle shield (<NUM>) of an injection device, the cap assembly comprising:
- a collar (<NUM>),
- a cap (<NUM>) with a sheath (<NUM>) and a bottom (<NUM>),
wherein the collar (<NUM>) is movable along a longitudinal direction relative to the sheath (<NUM>) from an unlocked position (U) not engaging the sheath (<NUM>) towards a locked position (L),
wherein in the locked position (L) the sheath (<NUM>) is force-lockingly engaged with the collar (<NUM>), thereby locking the sheath (<NUM>) to the needle shield (<NUM>),
wherein the sheath (<NUM>) is formed as a rigid tube (<NUM>) adapted to receive the collar (<NUM>) not engaging the needle shield (<NUM>) in its unlocked position (U), wherein the cap assembly further includes the needle shield (<NUM>), and wherein the collar (<NUM>) is radially compressible and formed as a conical neck narrowing towards its distal end such that the collar (<NUM>) is radially compressed by the sheath (<NUM>) and force-lockingly engages the needle shield (<NUM>) in its locked position (L) when the sheath (<NUM>) is moved proximally.