Patent Description:
A large number of medicament delivery devices on the market and developed during the last <NUM> years are arranged with a protective cap at the proximal end thereof that on the one hand protect the proximal end of the medicament delivery device, which proximal end is arranged with a dose delivery member such as an injection needle. The injection needle for instance has to be kept sterile before use, whereby it is surrounded by a covering material such as a sheath of e.g. rubber, creating a so called flexible needle shield or FNS. Further developments in that regard are the so called rigid needle shields or RNS's that have an outer shell of a more rigid material surrounding the flexible inner sheath. The main purpose in any event is to keep the injection needle protected and sterile.

The safety cap on the other hand usually has two functions, to protect the medicament delivery member and other elements at the proximal end of the medicament delivery device and on the other hand provide an aid for removing the medicament delivery member shield when the medicament delivery device is to be used. It is designed to facilitate for a user to pull off the safety cap and at the same time the medicament delivery member shield.

A common design of a safety cap comprises a generally tubular outer body releasably attached to an end of the medicament delivery device and often provided with grip means for facilitating the removal. Inside the body, a generally tubular medicament delivery member guard remover is attached. The remover often comprises inclined tongues that grip into the material of the medicament delivery member guard or needle shield so that the needle shield is pulled off when the safety cap is pulled off.

The body of the safety cap and the remover are arranged with attachment elements. Often the remover is attached to the body of the safety cap by tongues or ledges on an inner surface of a proximal end wall of the safety cap interacting with grooves or cut-outs or the like on one end of the remover or vice versa. From an assembly perspective, this is not optimal since the remover has to be inserted into body of the safety cap from a distal end and the attachment elements have to inter-connect, where the whole process requires rather tight tolerances and precise alignment of the components in order to properly attach the remover to the body.

<CIT> discloses a protective cap according to the preamble of claim <NUM>. J There is thus room for improvements regarding manufacture and assembly of safety caps.

In the present disclosure, when the term "distal" is used, this refers to the direction pointing away from the dose delivery site. When the term "distal part/end" is used, this refers to the part/end of the delivery device, or the parts/ends of the members thereof, which under use of the medicament delivery device is/are located furthest away from the dose delivery site. Correspondingly, when the term "proximal" is used, this refers to the direction pointing to the dose delivery site. When the term "proximal part/end" is used, this refers to the part/end of the delivery device, or the parts/ends of the members thereof, which under use of the medicament delivery device is/are located closest to the dose delivery site.

The aim of the present application is to remedy the drawbacks of the state of the art devices. This aim is solved by a protective cap arrangement comprising the features of the independent claim. Preferably embodiments of the present application form the subject of the dependent claims.

According to one aspect, a protective cap to be releasably connected to a medicament delivery device having a medicament delivery member shield. The cap comprises a generally tubular body, a generally tubular medicament delivery member shield remover for removing the medicament delivery member shield. The medicament delivery member shield remover comprises an attachment element. The protective cap comprises a lid attached to the tubular body so that the medicament delivery member shield remover is held in place in this position by the end lid been in contact with the attachment element of the medicament delivery member shield remover. The attachment elements are for holding the generally tubular medicament delivery member shield remover. The lid is attached to said body for holding said medicament delivery member shield remover in fixed position. This provides an easy and effective assembly setup of a safety cap.

Moreover, the protective cap tubular body comprises an end wall provided with a passage through which said medicament delivery member shield remover protrudes. In this regard, an attachment element comprises radially outwardly extending a circumferential flange with two support surfaces on said medicament delivery member -shield remover proximal end, which support surfaces are positioned between and facing the end wall and the lid. Thus, from an assembly point of view, it is easy to enter or insert the medicament delivery member guard into the passage from the proximal end of the cap and then attach the lid, providing a protective safety cap with an integrated medicament delivery member shield remover with fewer assembly steps.

According to a further aspect, the end wall is arranged with a seat or a recess for support surfaces, and the support surfaces may comprise a single circumferential flange as an attachment element or a number of circumferential extensions (not shown) as a plurality of the attachment elements. Also, the lid may be arranged with distally directed arms, which arms are arranged with ledges wherein the arms are designed to fit into openings of the body and the ledges will snap around edges of the openings. In this regard, the arms may be arc-shaped and provided with radially outwardly directed ledges, and that the openings are arc-shaped. Preferably, the openings may be arranged in the end wall. Additionally, the lid may further be arranged with a number of distally directed protrusions or ledges which are to be in contact with the flange or the attachment elements of the medicament delivery member shield remover.

These and other aspects of, and advantages with, the present invention will become apparent from the following detailed description of the invention and from the accompanying drawings.

The medicament delivery device <NUM> shown in the drawings comprises a generally tubular housing <NUM> having a proximal end <NUM> and a distal end <NUM>. Inside the housing a generally transversal wall <NUM> is arranged, <FIG>, which wall <NUM> is provided with a central passage <NUM>. Cut-outs <NUM> are further arranged on opposite sides of the passage <NUM>. A seat <NUM> is surrounding the passage <NUM>. Further generally rectangular windows <NUM> are arranged in the housing, which windows <NUM> are arranged with inwardly directed wall sections <NUM>. The proximal parts of the wall sections <NUM> are attached to or form part of the transversal wall <NUM>. Further, a number of longitudinally extending ribs <NUM> are arranged on the inner surface of the housing, having inwardly directed protrusions <NUM> at the proximal end thereof, the function of which will be described below. Moreover, at the distal area of the housing generally radially flexing tongues <NUM> are arranged, which tongues <NUM> are arranged with inwardly extending ledges <NUM> at their free ends.

Inside the housing, a medicament container holder <NUM> is arranged coaxially. The medicament container holder <NUM> comprises a generally elongated tubular body <NUM> having a distal passage <NUM> and a proximal passage <NUM>. The proximal passage <NUM> is arranged with an inwardly directed ledge <NUM> stretching around the circumference. The body <NUM> is arranged with two elongated slits <NUM> on opposite sides of the body. One of the slits <NUM> extends all the way to the proximal end, connecting the slit with the proximal passage, creating a C-shaped appearance when viewing in the distal direction. The circumferential ledge is further arranged with a number of cut-outs <NUM>, three in the embodiment shown, for providing flexibility of the proximal part of the medicament container holder as will be described. The longitudinal sides of the slits <NUM> are arranged with outwardly directed ledges <NUM>, which ledges <NUM> are designed to be in contact with inwardly surfaces <NUM> surrounding the windows <NUM> of the housing, for providing orientation and rotational fixation in relation to the housing. The medicament container holder <NUM> is arranged to accommodate a medicament container <NUM> that in the embodiment shown is a syringe, having an injection needle <NUM> as a medicament delivery member attached to a proximal end thereof and a stopper <NUM> of resilient material that is movable inside the tubular body of the medicament container <NUM>.

The medicament delivery device further comprises a medicament delivery member guard <NUM>, <FIG> and <FIG>. The medicament delivery member guard <NUM> comprises a proximal generally tubular body <NUM> provided with a central passage <NUM> in a transversal end wall <NUM>. Two oppositely positioned arms <NUM> are arranged to the distal area of the body <NUM> and extending in the distal direction. The arms <NUM> are arranged with longitudinal slits <NUM> which are to cooperate with the longitudinal ribs <NUM> of the interior of the housing. At the distal end of the arms <NUM>, outwardly directed ledges <NUM> are provided. Further on the inner surface of the arms <NUM>, inwardly directed protrusions <NUM> are arranged, the function of which will be described. A medicament delivery member guard spring <NUM> is further arranged between a distally directed surface of the transversal end wall <NUM> of the medicament delivery member guard <NUM> and a proximally directed surface of the wall <NUM>. In this regards, proximally directed support protrusions <NUM>, Figs. 3b and <FIG>, are provided on the wall <NUM> for supporting the medicament delivery member guard spring <NUM> and preventing it from accidentally interacting with the arms <NUM> of the medicament delivery member guard <NUM>.

The medicament delivery device <NUM> shown also comprises a power pack or drive unit <NUM>. The power pack <NUM> comprises an actuator <NUM> provided with a distal portion forming an end cap <NUM> of the medicament delivery device when the actuator is connected to the housing. The proximal part of the actuator <NUM> comprising a generally elongated tubular body <NUM>. A transversal support surface <NUM> is arranged in the area between the end cap <NUM> and the body <NUM>, which support surface <NUM> is designed to cooperate with the ledges <NUM> of the tongues <NUM> on the housing <NUM> for locking the actuator <NUM> to the housing <NUM> as seen in <FIG>. The body <NUM> is further arranged with proximally directed arms <NUM> that are flexible in a generally radial direction. The free ends of the arms <NUM> are provided with inwardly directed protrusions <NUM>. These inwardly directed protrusions <NUM> are arranged to fit into and cooperate with recesses <NUM> in an elongated plunger rod <NUM>, which plunger rod <NUM> is intended to fit into and be coaxial with the body <NUM> of the actuator <NUM>.

Further, a drive spring <NUM> is arranged inside the plunger rod <NUM> as well as a bracket <NUM> having a transversal distal part <NUM> and two proximally extending arms <NUM> on either side of, and outside, the drive spring <NUM>. The ends of the arms <NUM> are arranged with outwardly extending ledges <NUM>, which ledges <NUM> are to be in contact with proximally directed edge surfaces <NUM> of the body <NUM> of the actuator <NUM>. Inside the drive spring <NUM> a guide rod <NUM> is arranged, provided with a disk <NUM> at its distal end. The drive spring <NUM> is thus arranged between a proximal end wall <NUM> of the plunger rod <NUM> and the transversal distal part <NUM> of the bracket <NUM> via the disk <NUM> of the guide rod <NUM>, <FIG>. Further, at the proximal end of the body <NUM>, arc-shaped support elements <NUM> are arranged, which are flexible in the generally longitudinal direction and are intended to be in contact and support the medicament container <NUM> in the distal direction.

Moreover, the free ends of the arms <NUM> of the body <NUM> are arranged with outwardly directed protrusions <NUM> that are intended to cooperate with inner surfaces <NUM> of a generally tubular rotator <NUM> that is arranged outside and coaxial with the body <NUM> of the actuator <NUM>. The inner surface <NUM> of the rotator <NUM> is arranged with longitudinally extending grooves <NUM>, <FIG>, the function of which will be described below. The outer surface of the rotator <NUM> is arranged with guide ledges or ribs <NUM>, where some are extending in the longitudinal direction <NUM> and some are inclined 126i in relation to the longitudinal direction as will be explained. Adjacent one longitudinal guide rib <NUM>, a proximally directed tongue <NUM> is arranged, which tongue <NUM> is flexible in the generally radial direction, and where the free end of the tongue <NUM> is arranged with an outwardly directed, wedge-shaped, protrusion <NUM>.

The medicament delivery device <NUM> is further arranged with a safety cap <NUM>, <FIG> and <FIG>, comprising a generally tubular body <NUM> having a distal passage <NUM>. In order to provide a good fit between the safety cap <NUM> and the medicament delivery device <NUM>, the inner surface of the body <NUM> of the safety cap <NUM> may be arranged with a circumferential ledge <NUM>, which ledge <NUM> is arranged to interact with protrusions <NUM>, <FIG>, on the outer surface of the body <NUM> of the medicament delivery member guard <NUM> as seen in <FIG>. The body <NUM> of the safety cap <NUM> is further arranged with a distally directed end surface <NUM>, <FIG> and <FIG>, that acts as an abutment surface against a proximally directed end surface <NUM>, <FIG> and <FIG>, of the housing <NUM>, which end surface <NUM> also acts as an abutment surface such that the surfaces <NUM>, <NUM> provide a specific position of the protection safety cap <NUM> when mounted onto the medicament delivery device <NUM>.

Moreover, the body <NUM> of the safety cap <NUM> is arranged with a proximal end wall <NUM>, which end wall <NUM> is arranged with a central circular passage <NUM>. Radially outside the central passage <NUM> are two oppositely positioned arc-shaped openings <NUM>. Alternatively, only one opening of a suitable shape can be provided (not shown here). A generally tubular medicament delivery member shield remover <NUM> is to be positioned in the central passage <NUM> of the end wall <NUM>, wherein the medicament delivery member shield remover <NUM> will extend into the body <NUM> of the safety cap <NUM>. The proximal end of the medicament delivery member shield remover <NUM> is arranged with an outwardly extending ledge <NUM>, which ledge or flange <NUM> is arranged to be seated in a seat or a recess <NUM> in the end wall <NUM> of the body <NUM>. The medicament delivery member shield remover <NUM> is held fixed in place in this position by an end lid <NUM>. The end lid <NUM> is arranged with a couple of distally directed arc-shaped arms <NUM> as illustrated in <FIG>, provided with radially outwardly directed ledges <NUM>, wherein the arms <NUM> are designed to fit into the arc-shaped openings <NUM> of the body <NUM> and the ledges <NUM> will snap around edges of the arc-shaped openings <NUM>, locking the end lid <NUM> to the body <NUM> of the safety cap <NUM>. Alternatively, only one distally directed arm of a suitable shape or an arm comprising a couple of flexible fingers (now shown) can be arranged. The end lid <NUM> is further arranged with one or a number of distally directed protrusions or ledges <NUM> which are to be in contact with the ledge <NUM> of the medicament delivery member shield remover <NUM>, holding it in place in the recess <NUM>, see <FIG>.

The end lid <NUM> is arranged with further protrusions <NUM> at the edge of the end lid <NUM> that are in contact with the end wall <NUM> of the body <NUM>, creating a space <NUM> between the body <NUM> and the end lid <NUM>, <FIG>. The diameter of the end lid <NUM> is further chosen such in relation to the proximal edge of the body <NUM> such that gaps <NUM> are created around the circumference. The design provides an air passage through the protective safety cap <NUM>, as seen by the arrow in <FIG>, preventing possible sufFocation should a child for example put the safety cap <NUM> in the mouth. Moreover, the distal end of the medicament delivery member shield remover <NUM> is arranged with generally proximally and inwardly inclined tongues <NUM> that are designed to be in contact with and engage a medicament delivery member shield <NUM> such as a rigid needle shield or a flexible needle shield, covering the medicament delivery member such as the injection needle <NUM>.

Also, the protective safety cap has a facilitated assembly procedure in that the medicament delivery member shield remover <NUM> is simply entered into the central passage <NUM> of the end wall <NUM> of the body <NUM> from the proximal side until the ledge <NUM> is seated in the recess <NUM> in the end wall <NUM>. Then the end lid <NUM> is simply pushed onto the proximal end of the body <NUM> such that the arms <NUM> fit into the openings and the ledges <NUM> snap around the edges of the openings <NUM> of the body <NUM>. A very simple, fast and effective assembly way of the protective safety cap is obtained by the solution.

The medicament delivery device according to the drawings is intended to function as follows. The medicament delivery device is delivered to a user with the safety cap <NUM> attached to the proximal end of the medicament delivery device. The medicament delivery member guard <NUM> is in an extended position in relation to the housing <NUM> such that when the abutment surface <NUM> of the safety cap <NUM> is in contact with the abutment surface <NUM> of the housing, the circumferential ledge <NUM> is distally of, and in contact with, the protrusions <NUM> of the medicament delivery member guard <NUM> as seen in <FIG>. This provides a very secure fit, reducing the risk for premature release of the safety cap <NUM>.

The medicament delivery device is generally activated by the medicament delivery member guard <NUM> being pushed into the housing <NUM> when the proximal end of the medicament delivery device is pressed against a dose delivery site, as will be described. This may happen accidentally if the medicament delivery device is dropped against a hard surface such as a floor. Now there is a risk that the medicament delivery device <NUM> is activated in that the medicament delivery member guard <NUM> may be moved in relation to the housing <NUM> due to the impact forces, which might trigger the medicament delivery device. This risk is reduced and minimized in that the medicament delivery member guard <NUM> is held by the engagement with the safety cap <NUM> by the protrusions <NUM> interacting with the ledge <NUM>.

The user may now press the proximal end of the medicament delivery device <NUM> against the dose delivery site, whereby the medicament delivery member guard <NUM> is pushed into the housing <NUM>, causing a penetration by the injection needle <NUM>. The movement of the medicament delivery member guard <NUM> will cause its protrusions <NUM> at the distal end to slide in relation to the rotator <NUM>. When the protrusions <NUM> reach the inclined guide ribs 126i of the rotator <NUM>, the rotator <NUM> will rotate in relation to the actuator <NUM>, which in turn causes the outwardly protrusions <NUM> of the arms <NUM> of the actuator <NUM> to be moved in position with the longitudinal grooves <NUM> on the inner surface <NUM> of the rotator <NUM>. The arms <NUM> are thereby free to move radially outwards, whereby the engagement between the inwardly directed protrusions <NUM> and the recesses <NUM> of the plunger rod <NUM> is removed, releasing the plunger rod <NUM>. The plunger rod <NUM> is then urged in the proximal direction by the force of the drive spring <NUM>. The plunger rod <NUM> will now act on and move the stopper <NUM> of the medicament container <NUM> in the proximal direction, expelling a dose of medicament through the injection needle <NUM>. At the end of the injection sequence, the distal end of the plunger rod <NUM> will pass the bracket <NUM> whereby the arms <NUM> of the bracket <NUM> are free to move radially inwards, wherein the ledges <NUM> are moved out of contact with the surfaces <NUM> of the actuator <NUM>. Because the distal end of the drive spring <NUM> is in contact with the transversal distal part <NUM> of the bracket <NUM> via the disk <NUM> of the guide rod <NUM> and since the drive spring <NUM> has a residual force, the bracket <NUM> will be forced suddenly in the distal direction until the distal end of the bracket <NUM> hits an end wall of the actuator <NUM>, causing a tactile and audible signal to the user that the injection sequence is completed and that it is safe to remove the medicament delivery device from the dose delivery site.

The user can now remove the medicament delivery device <NUM> whereby the medicament delivery member guard <NUM> is pushed in the proximal direction by the medicament delivery guard spring <NUM>. This will cause the protrusions <NUM> of the medicament delivery member guard <NUM> to move such that they come in contact with and pass the wedge-shaped protrusions <NUM> of the tongues <NUM> of the rotator <NUM>. The passing of the protrusions <NUM> will cause a locking of the medicament delivery member guard <NUM> in the extended position, covering the injection needle <NUM>, in turn preventing accidental injuries on the injection needle <NUM>. The medicament delivery device can now be discarded.

Regarding the securing of the medicament delivery member guard <NUM> it is to be understood that several other alternatives are feasible. Instead of discrete protrusions on the outer surface of the medicament delivery member guard <NUM>, there could for example be a continuous protrusion <NUM> running along the circumference as seen in <FIG>. As an alternative, there could be a recess in the medicament delivery member guard <NUM> and protrusions on the inner surface of the body of the safety cap <NUM>. It is to be understood that the recesses in the medicament delivery member guard <NUM> could either be continuous <NUM> as seen in <FIG> or discrete <NUM> as seen in <FIG>. As a further alternative, the protrusion on the inner surface of the safety cap <NUM> may be discrete <NUM> instead of continuous, <FIG>. As yet an alternative there may be recesses on the inner surface of the safety cap <NUM>, either continuous <NUM>, <FIG> or discrete <NUM>, <FIG>. As understood there are many variants that may be combined in order to obtain the desired function of enhanced safety against accidental activation.

Claim 1:
A protective cap (<NUM>) to be releasably connected to a medicament delivery device (<NUM>) having a medicament delivery member shield (<NUM>), the cap (<NUM>) comprising a generally tubular body (<NUM>) and a generally tubular medicament delivery member shield remover (<NUM>) for removing the medicament delivery member shield (<NUM>), the medicament delivery member shield remover (<NUM>) comprises an attachment element (<NUM>) on the proximal end and the protective cap (<NUM>) comprises a lid (<NUM>) attached to the protective cap tubular body (<NUM>) proximal end so that the medicament delivery member shield remover (<NUM>) is held in place in this position by the end lid (<NUM>) being in contact with the attachment element (<NUM>) of the medicament delivery member shield remover (<NUM>),
wherein the tubular body (<NUM>) comprises an end wall (<NUM>) provided with a passage (<NUM>) through which the medicament delivery member shield remover (<NUM>) protrudes and at least one opening (<NUM>),
wherein the attachment element (<NUM>) comprises radially outwardly extending support surfaces on the medicament delivery member shield remover (<NUM>), which support surfaces are positioned between the end wall (<NUM>) and the lid (<NUM>),
wherein the end wall (<NUM>) is arranged with a seat, namely a recess (<NUM>), for said support surfaces;characterized in that
the end lid (<NUM>) is further arranged with one or more distally directed protrusions (<NUM>), wherein the one or more protrusions (<NUM>) are in contact with the ledge (<NUM>) of the medicament delivery member shield remover (<NUM>) so as to hold the medicament delivery member shield remover (<NUM>) in place in the recess (<NUM>).