Patent Description:
A large number of medicament delivery devices on the market and developed during the last <NUM> years are arranged with a protective safety 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 protective 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 protective safety cap and at the same time the medicament delivery member shield.

<CIT> discloses a medicament delivery device with a delivery member shield remover comprising a generally plate-shaped lid.

Even if the protective safety cap is necessary for the medicament delivery device, it is a component that can cause dangerous situations. This can for example be the case if for example a child gets hold of a removed protective safety cap and puts it in the mouth. The safety cap is too large to be swallowed but may cause the risk of sufFocation if it is stuck in the mouth.

There is thus a need for minimizing the risk of sufFocation if the safety cap is accidentally put in the mouth.

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 according to claim <NUM>, comprising at least one opening or a plurality of the openings in the proximal area of the protective cap for forming an air passage through the protective cap.

The preferred embodiments of the present application form the subjects of the dependent claims.

According to one aspect, a protective cap releasably connected to a medicament delivery device, comprises one or a plurality of openings in the proximal area of the protective cap for forming air passage or passages through the protective cap. With this solution, the risk of sufFocation if for example a child puts the protective safety cap in the mouth is greatly reduced, because the air passages will ascertain that it is still possible to breath even with the safety cap in the mouth.

The protective cap comprises a generally tubular body and a lid attached to the proximal end, and spacers arranged between the body and the lid for creating the air passages. This is an easy way to create the desired air passages. Further, the diameter of the lid may be chosen such in relation to a proximal edge of the body that gaps are created around the circumference of the lid.

In order to attach the lid to the body, the lid is 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. This provides a fast and uncomplicated assembly process. In this regard, the arms may be arc-shaped and provided with radially outwardly directed ledges, and that the openings are arc-shaped. Further, the body may be arranged with an end wall in which the openings are arranged.

As a further feature, the protective cap may comprise a medicament delivery member shield remover, attached to the body and held in position by the lid. In this regard, the lid may further be arranged with a number of distally directed protrusions or ledges which are to be in contact with a ledge of the medicament delivery member shield remover, holding it in place.

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 coaxial. 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> 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 (<NUM>) 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>, <FIG> 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 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> and <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 is further arranged with a safety cap <NUM>, <FIG>, <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> and <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 safety cap <NUM> when mounted onto the medicament delivery device.

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>. 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 <NUM> is arranged to be seated in a recess <NUM> in the end wall <NUM> of the body <NUM>. The medicament delivery member shield remover <NUM> is held in place in this position by an end lid <NUM>. The end lid <NUM> is arranged with distally directed arc-shaped arms <NUM>, 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>. The end lid <NUM> is further arranged with 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>, acting as spacers for 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 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 injection needle <NUM>.

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 (<NUM>) 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 accidental impact forces, which might premature 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>.

When the safety cap <NUM> is removed, the medicament delivery member shield remover <NUM> grips the medicament delivery member shield <NUM> with its tongues <NUM>, whereby also the medicament delivery member shield <NUM> is removed. 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>), wherein the protective cap (<NUM>) comprises an opening (<NUM>) in the proximal area of the protective cap (<NUM>) for forming an air passage through the protective cap (<NUM>);
the protective cap (<NUM>) comprising a generally tubular body (<NUM>) and a lid (<NUM>) attached to the proximal end, and spacers (<NUM>) arranged between the tubular body (<NUM>) and the lid (<NUM>) for creating the air passage;
wherein the lid (<NUM>) is arranged with distally directed at least two arms (<NUM>), which arms (<NUM>) are arranged with ledges (<NUM>), wherein the arms (<NUM>) are designed to fit into at least two openings (<NUM>) of the tubular body (<NUM>) and the ledges (<NUM>) will snap around edges of the openings (<NUM>).