Mounting arrangement and coupling assembly for a drug-delivery device

A mounting arrangement for a drug-delivery device is proposed, the mounting arrangement comprising: a plug element with a longitudinal axis (L) and a housing part having a recess with a side wall which is adapted to receive the plug element. At least one of the plug element or the side wall of the recess are provided with a protrusion for fixing the plug element in a given position relative to the housing part by a force-fit engagement. Furthermore, a coupling assembly is proposed, the coupling assembly comprising the plug element and the housing part being mechanically coupled to each other.

FIELD OF INVENTION

The present disclosure relates to a mounting arrangement and a coupling assembly with a housing part and a plug element suitable for use in a drug-delivery device. The drug-delivery device is preferably designed as a pen-type injector by which a number of predetermined or user-settable doses of a medical or pharmaceutical product can be administered. In particular, the present disclosure relates to a drug-delivery device which can be used by a person without formal medical training, e.g. advanced medical education.

BACKGROUND

Drug-delivery devices are in widespread use. For example, they can be applied by persons who do not have a formal medical background. Medical devices can be used to administer accurate and predefined doses of a medical product such as heparin or insulin. In particular, such devices can be used for a healthcare therapy whenever there is demand for a medical or pharmaceutical product being administered on a regular or an irregular basis over a short term or a long term period.

These circumstances set a number of requirements for the drug-delivery device of this kind which should be met. The device should be robust in construction, yet easy to use in terms of the manipulations of the parts, easily to be understood by the operator concerning the handling, and/or be suitable for an accurate delivery of the required dose of the medical or pharmaceutical product. Dose setting should be easy and unambiguous. In cases when the device is to be disposable rather than reusable, the device should be cheap to manufacture and easy to dispose of.

SUMMARY

The object of the invention is to provide a mounting device and a coupling assembly which are reliable and cheap to manufacture. The object is obtained by the features of the independent claims. Advantageous embodiments are disclosed in the sub claims.

According to a first aspect, a mounting arrangement for a drug-delivery device is provided. The mounting arrangement may comprise a plug element. The plug element may comprise.a longitudinal axis. The mounting arrangement may comprise a housing part. The housing part may have a recess with a side wall which is adapted to receive the plug element. At least one of the plug element and the side wall of the recess may be provided with a protrusion. The protrusion may be adapted and arranged for releasably or permanently fixing the plug element in a given position relative to the housing part by a force-fit engagement.

This may enable a cheap manufacturing of the housing part and the plug element. Furthermore, by plugging the plug element into the recess of the housing part, a very reliable mechanical coupling may be established. In particular, the mechanical coupling may be suitable for use in a drug-delivery device requiring high precision with small tolerances for tiny mechanical components.

In a preferred embodiment, the longitudinal profile of the protrusion is inclined along a longitudinal end section of the protrusion for the purpose of facilitating the insertion of the plug element into the recess when establishing the force-fit engagement. This enables to reduce mechanical stress being exerted on the protrusion and the plug element and such may facilitate an accurate adjusting of the plug element relative to the housing part.

According to a further preferred embodiment, the longitudinal profile of the protrusion is inclined along the longitudinal end section such that the inclination is monotonous.

According to a further preferred embodiment, the inclination of the longitudinal profile is constant.

According to a further preferred embodiment, the longitudinal profile of the protrusion is arranged and designed such that the longitudinal angle between the longitudinal end section and the longitudinal axis is between 1° and 30°.

According to a further preferred embodiment, the longitudinal profile of the protrusion is designed such that it comprises the shape of a convex curve. This enables an easy plugging of the plug element into the recess of the housing part and increases a mechanical stability of the protrusion.

According to a further preferred embodiment, a longitudinal section of the protrusion is arranged adjacent to the longitudinal end section and has a constant radial distance relative to the longitudinal axis. This enables to increase a friction force of the force-fit engagement by increasing a contact surface between the protrusion and the plug element or the side wall of the recess and thus a reliable mechanical coupling.

According to a further preferred embodiment, a cross-section of the protrusion perpendicular to the longitudinal axis is designed such that the radial distance between the protrusion and the longitudinal axis decreases monotonously to a given minimum on a first side face. On a second side face which is adjacent to the first side face, the radial distance increases monotonously.

According to a further preferred embodiment, the cross-section is designed such that it has a triangular shape. This allows an easy manufacturing process of the protrusion. For example, the protrusion may be manufactured in a molding process.

According to a further preferred embodiment, the first side face and the second side face are arranged in an azimuth direction angle of about 60° relative to each other. This enables a high mechanical stability of the protrusion which still enables an easy and accurate mechanical coupling. A first edge between the first side face and the second side face may facilitate a guiding and fixing of the plug element into a predetermined position relative to the housing. In particular, the first edge may facilitate to guide and fix the plug element in a position such that the longitudinal axis of the plug element may be arranged congruently in regard to a longitudinal axis of the recess.

According to a second aspect, a coupling assembly for a drug-delivery device is provided. The coupling assembly may comprise a housing part having a recess with a side wall. The coupling assembly may further comprise a plug element with a longitudinal axis being arranged in the recess of the housing part at least partially. At least one of the plug element and the side wall of the recess may have a protrusion. The protrusion may be arranged at least partially in the recess of the housing part between the side wall of the recess and the plug element. The protrusion may be deformed in order to fix the plug element in a given position relative to the housing part in a force-fit engagement.

This may enable a very reliable mechanical coupling which may in particular be suitable for use in a drug-delivery device.

According to a further preferred embodiment, the coupling assembly comprises a plurality of protrusions. This enables a high mechanical stability by increasing friction forces with an increasing number of protrusions. This may further enable an accurate adjusting of the plug element relative to the housing part such that the plurality of protrusions facilitates a guidance of the plug element into a predetermined position relative to the housing part.

According to a further preferred embodiment, the plurality of protrusions is arranged such that any further axis running perpendicular to the longitudinal axis crosses at most one of the protrusions. This enables a reliable coupling assembly such that mechanical stress being exerted on the plug element and on the protrusions may be reduced. A precision of the adjustment may thus further be increased.

According to an embodiment, a drug-delivery device is provided. The device may comprise the previously described coupling assembly.

Preferably, at least two members of the drug-delivery device, e.g. a housing and a housing insert of the device, may be, releasably or permanently, coupled by means of the coupling assembly. The at least two members may be secured against translational and/or rotational movement with respect to each other by means of the coupling assembly.

According to an embodiment, the drug-delivery device is a pen-type device.

A pen-type device may comprise at least one, preferably two or more sleeves. These sleeves may be especially suited for being connected by means of the coupling assembly due to their essentially rotationally symmetrical shape.

According to a preferred embodiment, a mounting arrangement for a drug-delivery device comprises a plug element with a longitudinal axis and a housing part having a recess with a side wall which is adapted to receive the plug element, wherein at least one of the plug element and the side wall of the recess are provided with a protrusion for fixing the plug element in a given position relative to the housing part by a force-fit engagement.

According to a preferred embodiment, a coupling assembly for a drug-delivery device comprises

a housing part having a recess with a side wall,

a plug element with a longitudinal axis being arranged in the recess of the housing part at least partially,

wherein at least one of the plug element and the side wall of the recess have a protrusion being arranged at least partially in the recess of the housing part between the side wall of the recess and the plug element and being deformed in order to fix the plug element in a given position relative to the housing part in a force-fit engagement.

Elements of the same design or function are referenced by the same reference numerals in the figures.

DETAILED DESCRIPTION

FIG. 1shows a mounting arrangement comprising a plug element2with a front surface3and a lateral surface4. The plug element2further comprises a longitudinal axis L. A circumferential first chamfer6is arranged between the front surface3and the lateral surface4. The mounting arrangement further comprises a housing part8having a recess10with an opening11and a side wall12. A circumferential second chamfer14is arranged between the side wall12of the recess10and an upper side15of the housing part8. In a preferred embodiment, the front surface3of the plug element2has the shape of a cylinder and the recess10of the housing part8has the shape of a hollow cylinder. The housing part8may be a sleeve, for example. Alternatively, the plug element2may be a sleeve (not explicitly shown), e.g. a hollow cylinder. Preferably, the diameter of the plug element2being shown inFIG. 1is smaller than the diameter of the recess10inFIG. 1. The outer diameter of the plug element2is expediently smaller than the inner diameter of the recess10of the housing part8.

FIG. 2shows the mounting arrangement with the plug element2and the housing part8. Three protrusions16are arranged on the side wall12of the recess10. The protrusions16may also be arranged on the lateral surface4of the plug element2. It is also possible that the protrusions16are arranged on the side wall12of the recess10as well as on the lateral surface4of the plug element2. There may, for example, also be arranged five protrusions16on the side wall12of the recess. It is also possible that a different number of the protrusions16is arranged on the side wall12and/or the lateral surface4. In the following, it will only be referred to the protrusion16in singular knowing that there may be a plurality of protrusions16.

The mounting assembly is designed such that the plug element2and the housing part8can be mechanically coupled for establishing a coupling assembly. The coupling assembly can be such that the recess10receives the plug element2at least partially in order to fix it in a given position relative to the housing part8. In particular, the plug element2can be arranged in the recess10such that its longitudinal axis L is in parallel to a longitudinal axis of the recess10. The plug element2may for example be press fitted into the recess10of the housing part8. The protrusions16may take up slack or play between plug element2and housing part8, which may arise, for example, by the plug element2having an outer diameter which is less than the inner diameter of the recess of the housing part8, if the protrusions16are disregarded. A minimal distance between two protrusions16, which may face each other, is expediently less than the outer diameter of the plug element2.

The housing part8and the plug element2are preferably parts for a drug deliver device. A sleeve for the plug element has the advantage that an element of the drive mechanism, such as the piston rod, may be moved through the housing part and the plug element during operation of the device.

The coupling assembly is designed to fix the plug element2in the given position relative to the housing part8by a force-fit engagement. The force-fit engagement is established between the protrusion16being arranged between the lateral surface4of the plug element2and the side wall12of the recess. In the case that the protrusion16is arranged on the lateral surface4of the plug element2, the force-fit engagement is established between the protrusion16and the housing part8at the side wall12of the recess8. In a preferred embodiment however, the protrusion16is arranged on the side wall12as shown inFIG. 2. In this case, the force-fit engagement is established between the protrusion and the plug element2.

The plug element2and the recess10are designed such that with at least one protrusion16being arranged on the lateral surface4and/or the side wall12, the protrusion16and/or the plug element2is deformed during the assembly when the plug element2is plugged into the recess10. In a preferred embodiment, in the case that the protrusion16is arranged on the lateral surface4of the plug element2, when the plug element2is plugged into the recess10, the protrusion16and the plug element2are deformed and establish the force-fit engagement. In a further embodiment, the plug element2is made of a material having a smaller hardness in comparison to a hardness of the protrusion16such that the deformation rather concerns the plug element2. The plug element2may be, for example, made of plastic. The mounting assembly is designed such that the housing part8, except for the protrusion16, is effectively prevented from being deformed. In particular, the housing part8can effectively be prevented from breaking.

If the protrusion16is arranged on the side wall12of the recess10as shown inFIG. 2, the force-fit engagement is established between the protrusions16and the plug element2. However, it may also be possible that one or more protrusions16are arranged on the lateral surface4of the plug element2. In this case, a force-fit engagement is established between the protrusion16and the side wall12of the housing part8. There may, for example, protrusions16be arranged on the lateral surface4of the plug element2and on the side wall12of the housing part8.

The protrusion16is arranged and designed such that its longitudinal profile in regard to the longitudinal axis L inclines along a longitudinal section18. This may facilitate the insertion of the plug element2into the recess10during a manufacturing of the coupling assembly.

The protrusion16may, for example, be made in a molding process which is also known as die-casting. This may enable to manufacture the protrusion16integrally with the plug element2or the housing part8, depending on where it shall be arranged. The protrusion16may also be made in a different process. In a preferred embodiment, a plurality of protrusions16is arranged on the side wall12of the recess10and/or on the lateral surface4of the plug element2. In a further preferred embodiment, the plurality of protrusions16is arranged such that any further axis running perpendicular to the longitudinal axis L crosses at most one of the protrusions16. This enables a reliable coupling such that a friction force can be increased in order to strengthen the force-fit engagement. The deformation of the protrusion16and/or the plug element2may be plastically and/or elastically.

FIGS. 3A to 3Dshow a first embodiment of the protrusion16. In theFIGS. 3A to 3Dthe protrusion16is arranged on the side wall12of the recess10. However, the protrusion16may also be arranged on the lateral surface4of the plug element2.FIG. 3Ashows the first embodiment of the protrusion16in a front view. In the first embodiment, the protrusion16comprises a longitudinal end section18having a first side face20and a second side face22, the first side face20and the second side face22being separated from each other by a first edge24. In a longitudinal direction, the first edge24is arranged between a first corner26and a free corner28. In the case when the protrusion16is arranged on the lateral surface4of the plug element2, the first axial end26of the protrusion16is arranged in the direction towards the front surface3of the plug element2. In the case when the protrusion16is arranged on the side wall12of the recess10, the first axial end26of the protrusion is arranged in the direction towards the opening11of the recess10.

FIG. 3Bshows the longitudinal profile of the protrusion16in regard to the longitudinal axis L. A radial distance R between the side wall12of the recess10and the free corner28can also be named as the radius of the protrusion16. In a preferred embodiment, the protrusion16is designed such that the radial distance R increases with an increasing distance to the first axial end26. The radial distance R of the protrusion may be, for example, 0.25 Millimeter. In other words, the longitudinal profile of the protrusion16inclines along the longitudinal end section18. In a further preferred embodiment the longitudinal profile of the longitudinal end section18is designed such that the radial distance R increases at a constant rate with an increasing distance to the first axial end26, as it is shown in theFIGS. 3B and 3D. In other words, the longitudinal profile of the longitudinal end section18is designed such that its inclination is constant. In a preferred embodiment, the longitudinal profile of the protrusion16is arranged and designed such that a longitudinal angle A1between the longitudinal end section18and the longitudinal axis L is between 1° and 30°.

FIG. 3Cshows the first embodiment of the protrusion16from an above view. The free edge24being arranged between the first axial end26and the free corner28can serve for guiding the plug element2relative to the housing part8during the mechanical assembly of the plug element2and the housing part8. During the assembly, the first edge24may be cut into the plug element16. As such, the first edge24may be designed as a cutting-edge.

FIG. 3Dshows the first embodiment of the protrusion16in a perspective view. An azimuth direction angle A2between the first side face20and the second side face22may for example be between 15° and 90°. In a preferred embodiment, the azimuth direction angle A2between the first side face20and the second side face22is about 60°. This enables a reliable coupling assembly such that on the one hand the azimuth direction angle A2enables a high mechanical stability of the protrusion16preventing breakage and on the other hand, it is thin enough for enabling a deformation of the plug element2when being plugged into the recess10.

FIGS. 4A and 4Bshow a second embodiment of the protrusion16.FIG. 4Ashows the longitudinal profile of the protrusion16. In a preferred embodiment, the free edge24between the first axial end26and the free corner28comprises a convex bending. The free edge24between the first axial end26and the free corner28may, for example, comprise a first part with a convex bending and second part being designed in parallel to the longitudinal axis L.

FIG. 4Bshows the second embodiment of the protrusion16in a perspective view. InFIG. 4Bthe convex bending extends over the length of the free edge24.

FIGS. 5 and 6show a third embodiment of the protrusion16from a perspective view and in the longitudinal profile respectively. The third embodiment of the protrusion16as shown in theFIGS. 5 and 6comprises the longitudinal end section18as shown inFIGS. 3A to 3Dand a longitudinal section30being arranged on an opposite side relative to the first axial end26of the longitudinal end section18. However, the third embodiment of the protrusion16may also comprise the longitudinal end section18as shown in theFIG. 4A or 4Band the longitudinal section18.

In a preferred embodiment, the radial distance R of the longitudinal section30is constant. This enables a reliable coupling assembly such that the friction of the force-fit engagement between the protrusion16and the housing part8or the lateral surface4of the plug element2respectively can be increased. The cross-section32of the longitudinal section30may be, for example, shaped as a triangle. The cross-section32of the longitudinal section30may also be shaped differently. In a preferred embodiment, the cross-section32of the protrusion16is designed such that in a direction perpendicular to the longitudinal axis L the radial distance R decreases monotonously to a given minimum and afterwards increases monotonously.

FIG. 6shows the longitudinal profile of the third embodiment of the protrusion16comprising the longitudinal end section18and the longitudinal section30.

FIG. 7shows two protrusions16being arranged on the lateral surface such that the first side face20of a left-hand protrusion16ais in contact with the second side face22of a right-hand protrusion16b.

InFIG. 8an exemplary embodiment of a drug-delivery device40is shown. The drug-delivery device40comprises a housing41. The housing41comprises a tubular shape. The housing41may comprise or may be embodied as a sleeve. The housing41is configured to house members of the drug-delivery device40, e.g. a guide member, a drive member and/or a dosing member (not explicitly shown). Preferably, these members may comprise or may be embodied as a sleeve, respectively. Accordingly, these members may be rotationally symmetric. The drug-delivery device40comprises a cartridge holder42. The cartridge holder42is connectable, preferably releasably connectable, to the housing41of the device40.

The drug-delivery device40may be an injection device. The device40may be a pen-type device, in particular a pen-type injector.

The device40comprises the previously described coupling assembly (not explicitly shown). The coupling assembly may be adapted and arranged for providing a reliable mechanical coupling between members of the device40. Especially a pen-type device may comprise a plurality of sleeves. These sleeves may be especially suited for being coupled to each other by means of the coupling assembly due to their generally rotationally symmetric basic shape.

In particular, at least two members of the device40, e.g. the housing41and the guide sleeve, may be permanently or releasably coupled by means of the coupling assembly. In particular, axial and/or rotational movement of these members of the device40may be prevented by means of the coupling assembly.

The device40comprises a cartridge43. The cartridge43is retained in the cartridge holder42. The cartridge holder42stabilizes the cartridge43mechanically. The cartridge43may hold a plurality of doses of a drug.

The term “drug”, as used herein, preferably means a pharmaceutical formulation containing at least one pharmaceutically active compound, wherein in one embodiment the pharmaceutically active compound has a molecular weight up to 1500 Da and/or is a peptide, a proteine, a polysaccharide, a vaccine, a DNA, a RNA, a antibody, an enzyme, an antibody, a hormone or an oligonucleotide, or a mixture of the above-mentioned pharmaceutically active compound.

In a further embodiment the pharmaceutically active compound comprises at least one human insulin or a human insulin analogue or derivative, glucagon-like peptide (GLP-1) or an analogue or derivative thereof, or exedin-3 or exedin-4 or an analogue or derivative of exedin-3 or exedin-4.

wherein the group -Lys6-NH2 may be bound to the C-terminus of the Exendin-4 derivative; or an Exendin-4 derivative of the sequence

or a pharmaceutically acceptable salt or solvate of any one of the afore-mentioned Exedin-4 derivative.