RU2828348C1 - Cartridge assembly for drug delivery device and drug delivery device - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: invention relates to a cartridge assembly, particularly a cartridge assembly for a drug delivery device, preferably an injection device and/or a pen-type device, such as a pen-type injection device. Present invention also relates to a drug delivery device comprising a cartridge assembly. Cartridge assembly (300) for a drug delivery device comprises cartridge (301), cartridge holder (302), fastening element (322) and a region with reduced mechanical rigidity (350). Cartridge (301) contains drug (307). Cartridge holder (302) forms inner section (303) holding the cartridge, wherein the cartridge is located inside the cartridge holding section. Cartridge holder (302) comprises distal region (317) with needle connector (319) placed at the distal end of distal region (317), and body region (318). Fastening element (322) is placed in distal area (317). Area with reduced mechanical rigidity (350) compared to rigidity of area (318) of the main part is built into distal area (317) and is located between needle connector (319) and fastener (322), so that when cartridge (301) is moved in the proximal direction, the resulting load is transferred from cartridge (301) to fastener (322) and then to the main part area (318) in the proximal direction proximal direction. Fastening element (322) comprises a permanent mechanical connection with distal area (317) of cartridge holder (302) in circumferential direction. Drug delivery device (1) comprises body (10) and cartridge assembly (300) described above, which is detachably attached to the body, wherein drug (307) contained in the cartridge is a drug.

EFFECT: purpose of the present invention is to increase the stability of the cartridge fixed in the cartridge holder against attempts to remove the cartridge from the holder.

16 cl, 13 dwg

Description

The present invention relates to a cartridge assembly, in particular to a cartridge assembly for a drug delivery device, preferably an injection device and/or a pen-type device, such as a pen-type injection device. Furthermore, the present invention relates to a drug delivery device comprising the cartridge assembly.

In conventional drug delivery devices where a single actuator, which may be housed in a drug delivery device housing, is used in conjunction with multiple cartridges or ampoules to dispense a drug contained in a cartridge or ampoule from the device, typically a cartridge holder of the device is removably connected to the housing and can be removed from the housing to replace a used cartridge. To do this, the cartridge holder is disconnected from the housing, the used cartridge is removed from the holder and replaced with a new cartridge, which is inserted into the cartridge holder, wherein the cartridge holder is again attached to the housing and the device is ready for reuse to dispense a drug from a new cartridge.

However, there are several disadvantages to this type of device. For example, a cartridge containing a drug for which the specific mechanism of the drug delivery device is not intended, i.e. the wrong drug, may be inserted into the cartridge holder without the user realizing that he/she has inserted the wrong cartridge of drug into the cartridge holder. This error can be fatal to the user and is also likely to occur because cartridges with different drugs look almost identical. In addition, if the cartridge is sold as a separate item, this entails a certain risk of damage, particularly because standard cartridges are usually glass cartridges.

The present invention relates to a design of a cartridge retention system that is used within a drug delivery device.

The object of the present invention is to provide an improved cartridge assembly for a drug delivery device and/or further improvements or configurations related to the cartridge assembly. These objects and potentially other objects are achieved by the present invention and in particular by the subject matter of the independent claims. Advantageous embodiments and improvements are the subject matter of the dependent claims. One particular object of the present invention is to increase the stability of a cartridge secured in a cartridge holder against attempts to remove the cartridge from the holder. As will be apparent from the following description, this can be achieved by increasing the magnitude of the load moving along one or more load paths, especially within the cartridge holder, and/or by reducing the magnitude of the load moving along load paths that tend to cause radial deflection of the fastener, in particular when attempting to remove the cartridge from the cartridge holder.

One aspect of the present invention relates to a cartridge assembly, in particular to an assembly for a drug delivery device, such as a pen-type device and/or an injection device. Another aspect relates to a drug delivery device. The drug delivery device suitably comprises a cartridge assembly as described above and below in this document, and a housing.

The cartridge unit may be detachably attached to the housing. Inside the housing, a drive mechanism may be located, preferably configured to perform a dispensing action for dispensing a medicinal product from the cartridge, or at least one or more of its elements, such as a piston rod.

The cartridge unit comprises a cartridge. The cartridge unit comprises a cartridge holder. The cartridge holder may form an internal section that holds the cartridge. The section that holds the cartridge may be circumferentially limited by the cartridge holder, in particular by one or more parts thereof. The cartridge is expediently arranged inside the section that holds the cartridge. The cartridge unit further comprises a fastening element. The fastening element is expediently arranged so as to abut, or abuts, against a surface of the cartridge, in particular against a surface oriented in the radial direction. The fastening element may be arranged so as to prevent the cartridge from being removed from the cartridge holder. In this way, the cartridge may be permanently secured in the cartridge holder. The fastening element may be arranged so as to prevent the cartridge from being removed from the cartridge holder through an opening in the cartridge holder, preferably a proximal opening. This opening may be an opening through which the cartridge is inserted into the cartridge holder, for example during the assembly of the cartridge unit. The surface of the cartridge may be a proximal surface facing away from the dispensing end of the cartridge.

The cartridge holder comprises at least two outer regions. The outer regions may comprise or represent a distal region and a main part region. The distal region may be located closer to the dispensing end of the cartridge than the main part region. The distal end wall of the cartridge holder may limit the distal region in the distal direction. A needle connector is located at the distal end of the distal region. The main part region may retain the main part of the cartridge. The distal region may retain the head part of the cartridge within itself.

The fastening element is located in the distal region. The cartridge holder comprises a region with reduced mechanical rigidity compared to the rigidity of the region of the main part. This region is built into the distal region and is located between the needle connector and the fastening element, so that when the cartridge is moved in the proximal direction, the resulting load is transferred from the cartridge to the fastening element and then to the region of the main part in the proximal direction. The region can be aligned along the circumference of the distal region, the region of the main part or the shoulder region, which is aligned between the distal region and the region of the main part. In contrast to the known technical solution shown in Fig. 3A and 3B, the region with reduced mechanical rigidity according to the present invention can be positionally fixed. The region with reduced mechanical rigidity can be located in a certain position relative to the shoulder region and/or the distal region. By positional fixation it is meant that the region with reduced mechanical rigidity remains in a certain position relative to the shoulder region and/or the distal region where it was located. Conversely, the flexible arm shown in Fig. 3A and 3B can bend in the radial direction.

Preferably, the load transfer to the distal region is kept as small as possible or is avoided completely. By integrating a region with reduced mechanical rigidity into the distal region, a permanent mechanical connection of the fastening element and the distal region of the cartridge holder in the circumferential direction can be achieved, and access to the fastening element, for example for opening the fastening element, can be difficult.

During assembly, the fastener can bend outward more easily due to the area of reduced rigidity and allows the cartridge membrane retainer to move into the assembled position. The load path of the fastener is modified in the proximal direction for a situation where the cartridge is forced to move proximally relative to the cartridge holder, as may occur if the subassembly is dropped or if the user attempts to remove the cartridge from the cartridge holder. The fastener has a profile such that the cartridge can be assembled easily and simply by applying an axial load to the cartridge.

The cartridge contains the drug or medicinal product. The cartridge contains the dispensing end. The dispensing end can dispense the drug or medicinal product from the cartridge. The dispensing end of the cartridge may be called the distal end.

The modified load path increases the tendency of the fastener to bend inward and decreases the tendency of the fastener to bend outward in these scenarios. This increases the holding strength provided by the fastener.

In addition, the present invention provides for a repeatable and reliable assembly of the cartridge with passage into the cartridge holder by inserting the cartridge in the distal direction and applying force to the cartridge only in the distal direction, as provided by the standard equipment of the cartridge assembly. This reliably retains the cartridge within the cartridge holder in use and intended misuse scenarios.

The area with reduced mechanical rigidity may comprise a groove or a cutout. Providing a groove has the advantage that the cartridge holder is closed in the direction of the external environment. The shape and depth of the groove determines the rigidity of the material in this area. A larger and deeper groove provides reduced rigidity compared to a smaller and shallower groove. An even further reduced rigidity may be achieved by a cutout, which provides for the complete removal of the material through its thickness, which comprises the cutout. The groove or cutout may have a rectangular or rounded rectangular shape. The groove or cutout may be aligned near the main part. The cartridge holder may comprise a shoulder area, which is located between the distal area and the area of the main part. In this case, the groove or cutout may be located near the shoulder area in the distal direction.

The fastening element comprises a fastening surface, in particular a radially oriented surface. The fastening surface is expediently arranged in such a way as to rest against, or rests against, the surface of the cartridge, in particular the radially oriented surface. The fastening surface can be arranged in such a way as to prevent the cartridge from being removed from the cartridge holder. In this way, the cartridge can be permanently fastened in the cartridge holder.

The fastening surface may be arranged in such a way as to prevent the cartridge from being removed from the cartridge holder through an opening in the cartridge holder, preferably a proximal opening. This opening may be an opening through which the cartridge is inserted into the cartridge holder, for example when assembling the cartridge unit. The surface of the cartridge may be a proximal surface facing away from the dispensing end of the cartridge. The fastening surface may face the surface of the cartridge.

The fastening element and, in particular, the fastening surface may abut or may be arranged in such a way as to abut or mechanically interact with the cartridge, in particular with the surface of the cartridge, for fixing the cartridge in the cartridge holder. The surface of the cartridge may be located between the dispensing end of the cartridge and the end opposite to the dispensing end. In particular, the surface of the cartridge may be a surface different from the end surface of the cartridge, where two end surfaces, for example a distal end surface and a proximal end surface, limit the extension of the cartridge in the main longitudinal direction. The fastening element may be integrated into the cartridge holder. The fastening element may be, for example, a latch or a bracket.

In one embodiment, the fastening element fixes the cartridge in the axial direction inside the cartridge holder. In particular, the fastening element can prevent the cartridge from moving in the proximal direction relative to the cartridge holder. The fastening surface can constantly abut against the surface of the cartridge. In particular, the cartridge can be fixed in the axial direction in the cartridge holder by means of the fastening element. The cartridge can move in the distal direction relative to the cartridge holder by the proximal surface of the cartridge holder, for example by the inner surface of the distal end wall. The proximal surface can be offset in the distal direction relative to the fastening surface. The proximal surface and the fastening surface can be adjusted in such a way that a part of the cartridge, such as the head part, is preferably tightly located between the fastening surface and the proximal surface. In the case where a part of the cartridge is tightly placed between the surfaces, an additional elastic deflection element can be omitted, such as a spring for deflecting the cartridge, which deflects the cartridge in the distal direction relative to the cartridge holder in order to compensate for the mechanical play between the components. As an alternative, the cartridge is movable in the axial direction relative to the cartridge holder, for example by separating the proximal surface and the fastening surface by a distance exceeding the axial extension of the part of the cartridge located between them. In this case, an elastic deflection element can be preferably provided, for example in a drug delivery device, which deflects the cartridge in the distal direction relative to the cartridge holder, i.e. it maintains a state of abutment between the distal surface of the cartridge and the cartridge holder, for example the proximal surface of the cartridge holder. In this case, the surface of the cartridge can be located at a certain distance relative to the fastening surface. The deflection element can be a spring washer or another elastically deformable element. The deflecting element may rest against the cartridge, i.e. direct contact is possible, or transmit the force to the cartridge indirectly, for example, via a separator. The deflecting element may maintain the distance between the fastening surface and the cartridge surface.

The cartridge may be a glass cartridge.

In one embodiment, the fastening element projects from the inner wall of the cartridge holder, in particular in the radial direction. In this way, the diameter of the inner part of the cartridge holder can be reduced to a size that is smaller than the outer diameter of the cartridge and, in particular, the head part of the cartridge. The fastening element can be oriented in the radial direction or at an angle relative to the radial and axial direction.

In one embodiment, the fastening surface comprises a prominence facing the surface of the cartridge. The prominence may be on the edge of the fastening element or in the center. The surface of the cartridge may have a convex shape, preferably with a maximum in the center. The contact of the fastening surface with the surface of the cartridge is made in the center of the fastening surface.

In one embodiment, the fastening surface may be sloping and/or inclined relative to the axial and radial directions. The fastening surface may be oriented relative to the surface of the cartridge such that the surfaces face each other and are not parallel to each other. The fastening surface may contact the cartridge along the radially inner edge of the fastening element.

In one embodiment, the fastening element comprises a region with a reduced thickness compared to the thickness of the region of the main part. This can be achieved by removing material from its most radially distant part. This results in reduced rigidity in this region and greater flexibility of the fastening element.

In one embodiment, the region of reduced mechanical rigidity overlaps the fastener at an angle, coaxially or radially.

In one embodiment, the region of reduced mechanical rigidity is limited to a region distal to the fastener.

In one embodiment, a (sub)section of the region with reduced mechanical rigidity or the entire region is radially offset outward from the fastening element. This (sub)section can be connected to another (sub)section of the region with reduced mechanical rigidity, for example by an opening offset in the distal direction from the fastening element.

In one embodiment, the cartridge holding section comprises at least three internal regions, i.e. a first region, a region of the fastening element and a second region. The fastening element is expediently arranged in the region of the fastening element. The region of the fastening element may be located between the first region and the second region, in particular as seen in the soybean direction. The internal diameter, preferably the minimum internal diameter, or the clearance of the cartridge holder in the region of the fastening element is preferably smaller than the internal diameter, preferably the minimum internal diameter, or clearance in the first region and the internal diameter, preferably the minimum internal diameter, or clearance in the second region. The first region and the second region may have different and/or constant internal diameters or clearances. Accordingly, the fastening element may form a region with a reduced internal diameter. As described above, this internal diameter is preferably smaller than the outer diameter of the head portion of the cartridge. The first region may be a region of the cartridge holder in which the head portion is to be arranged, and the second region may be a region in which the main part of the cartridge is to be arranged. The extension in the axial direction of the first and second regions may be different. The extension in the axial direction of the second region may be greater than the extension in the axial direction of the first region. The fastening surface may limit the first region in the proximal direction. If the fastening element is located in a region where the internal diameter of the inner part of the cartridge holder changes in some way, the fastening element can be realized particularly easily by means of injection molding. The molding pins used in injection molding and defining the corresponding internal region of the cartridge holder in the molding tool may only need a small adjustment, so that the fastening element can be built into the cartridge holder in a region where pins of different diameters meet. Injection molding is particularly well suited for large volumes.

In one embodiment, the cartridge holding section of the cartridge holder comprises a distal inner region. The distal inner region may be located distally relative to the fastening surface of the fastening element. In other words, the distal inner region may be that region of the inner part of the cartridge holder where the head portion of the cartridge is to be located in the cartridge assembly when the cartridge is directed into the cartridge holder. A cartridge guide element may be provided in the distal inner region. The cartridge guide element may project radially from the inner wall of the cartridge holder, wherein the inner wall is located in the distal inner region. The cartridge guide element may be provided for interaction with the cartridge, for example with the membrane retainer, in order to move the cartridge, in particular its head portion, in the radial direction relative to the fastening surface. The cartridge guide element may be offset at an angle relative to the fastening element and/or the fastening surface. The cartridge guide element may be located opposite the fastening element. If a plurality of fastening elements are provided, the number of cartridge guide elements may be less than or equal to the number of fastening elements. However, one cartridge guide element may be sufficient, regardless of the number of fastening elements. The cartridge guide element may be distally offset relative to the fastening element. In other words, there may be an axial gap between the cartridge guide element and the fastening surface. The distal inner region is expediently designed to accommodate the head portion of the cartridge therein. Thus, it may correspond to the first region of the cartridge holder described above. The distance by which the cartridge guide element is distally offset relative to the fastening surface and/or the fastening element may be greater than or equal to the size or extent in the axial direction, for example the thickness, of the cartridge membrane. Alternatively or additionally, the distance by which the cartridge guide element is distally offset relative to the fastening surface and/or the fastening element may be less than the size or extent in the axial direction of the head portion of the cartridge. The head portion may comprise a head portion of the cartridge body, a membrane and a membrane retainer, such as a metal sleeve, by means of which the membrane is permanently attached to the cartridge body. By providing a guide element with such an offset in the distal direction, it is possible to ensure that the cartridge membrane passes the fastening element of the fastening surface before the cartridge interacts with the guide element, which is arranged so as to move the cartridge in the radial direction relative to the fastening surface so as to increase the overlap area between the fastening surface and the surface of the cartridge provided for interaction with the fastening surface for holding the cartridge in the cartridge holder.

The outer distal region may correspond to the first inner region, and the region of the main part may correspond to the second inner region with respect to the axial positions along the extension of the cartridge holder from the proximal opening to the distal end. The outer diameter of the cartridge holder may be smaller in the distal region than in the region of the main part. The fastening surface and/or the fastening element may be located in an axial position, in particular when viewed along the cartridge holder. The axial position may be in the distal region of the cartridge holder. Accordingly, the fastening surface may be located in the inner part of the cartridge holder in a position that overlaps the distal region, which may have a reduced outer diameter. Accordingly, the region of the fastening element may at least partially overlap the distal region in the axial direction.

In one embodiment, one of the first region or the second region comprises a distal inner region located in the distal direction relative to the fastening element, wherein the distal inner region comprises two regions with two different inner diameters, wherein the region with the smaller diameter of the two different diameters is located in the distal direction relative to the region with the larger inner diameter. The cartridge can be inserted into the cartridge holder along the distal direction through the opening at the proximal end of the cartridge. When moving in the distal direction, the cartridge creates contact with the fastening element. The fastening element is located in the region of the cartridge holder with the larger inner diameter. When the cartridge is moved further in the distal direction, it reaches the region with the smaller inner radius, so that the outer surface of the cartridge has a tighter contact with the inner wall of the cartridge holder compared to the region with the larger diameter.

The cartridge may have a main part and a head part connected by means of a narrow part, which may have a reduced diameter compared to the main part and/or the narrow part. The main part may be cylindrical. The dispensing end or opening of the cartridge may be located in the head part. The dispensing end or opening may be closed, for example, preferably by a pierceable and/or elastic membrane. The membrane may be pierced by a needle to provide fluid communication between the inside of the cartridge and the outside environment. The membrane may be attached to a cartridge body, for example made of glass. For example, the membrane may be attached to the cartridge body using a membrane retainer, for example a sleeve and/or using metal, for example a metal sleeve. The cartridge holder may comprise an opening limiting the cartridge holder in the proximal direction. The cartridge holder may be limited in the distal direction by a distal end wall. The distal end surface of the cartridge may be arranged so as to abut against the inner proximal surface of the cartridge holder. The proximal surface may be an inner surface formed by the distal end wall. In other words, the cartridge cannot move in the distal direction relative to the cartridge holder. The cartridge may be permanently fixed in the cartridge holder by a fastening element. Preferably, without the fastening element, the cartridge can be removed from the cartridge holder, for example through the proximal opening. The fastening surface may be a distal surface of the fastening element, i.e. a surface facing in the distal direction, for example in the opposite direction from the proximal opening of the cartridge holder.

Since the fastening element is integrated into the cartridge holder, for example formed as a single unit with the main part of the cartridge holder, the formation of the fastening element can be integrated into the normal manufacturing process of the cartridge holder, for example by injection molding, without the need to manufacture a separate fastening element and perform separate assembly steps for the appropriate placement of the fastening element relative to the cartridge and the cartridge holder in order to secure the cartridge within the cartridge holder.

In one embodiment, the outer surface or the outer wall of the cartridge holder, for example the side wall of the cartridge holder, extends along the entire fastening element and/or closes it, for example in the axial direction and/or at an angle or azimuthally. In other words, the cartridge holder can be closed in the radial direction, for example by the side wall, along preferably the entire angular or azimuthal extension of the fastening element and/or along preferably the entire extension in the axial direction of the fastening element. In contrast to the fastening element, which closes at an angle or in the axial direction an opening in the cartridge holder, such a configuration is easier to manufacture, for example by injection molding. Since the fastening element can be provided in a region where the cartridge holder does not have a radially extending opening, the fastening element is not as easily accessible from the outside as in the case when it is covered by such an opening or when it is formed by such an opening. This helps to prevent manipulation of the cartridge assembly.

The cartridge holder comprises, alternatively or in addition to the region with reduced rigidity, a region with increased mechanical rigidity, which can be located near the fastening surface in the proximal direction and which reduces the radial flexibility of the cartridge holder in such a region so that the movement of the cartridge in the proximal direction is difficult. The region with increased mechanical rigidity can be located on the inner or outer side wall of the cartridge holder.

In one embodiment, the cartridge holder is a single piece. In particular, the cartridge holder may be an injection molded piece. The cartridge holder comprising a distal region and a main portion region may then be made as a single piece. Although the cartridge holder is made as a single piece, it may nevertheless comprise an integrated fastening element that interacts with the proximal surface of the cartridge.

In one embodiment, the mounting surface is a flat surface.

In one embodiment, the cartridge holder has a distal end wall or a distal end surface. The distal end wall can be arranged to abut the distal surface of the cartridge. In particular, the proximal surface of the distal end wall can be arranged to abut the distal surface of the cartridge. The distal end wall can extend in an angular direction, in particular around the main longitudinal axis. The end wall can have or form at least one opening, such as a single opening or more than one opening. The opening can be limited by angular surfaces of the distal end wall facing each other. The opening can be in a position that overlaps the fastening surface or the fastening element in the radial and angular directions. In particular, the fastening surface and the opening can be provided in corresponding radial and angular positions, but in different axial positions in the cartridge holder. It is advisable that the fastening surface is offset in the proximal direction relative to the opening, in particular by a distance corresponding to the length in the axial direction of the head part or determined by this length.

In one embodiment, the angular and/or radial size of at least one opening may determine the angular and/or radial size of the fastening surface. Preferably, the angular and/or radial size of the opening is greater than or equal to the angular and/or radial size of the fastening surface. Thus, the fastening element may be formed by a molding tool that is guided through a region of the mold designed to form the distal end of the cartridge holder until the position where the fastening element is to be placed is reached.

The advantage of the opening in the distal end wall of the cartridge holder is that in the area of the opening and the area extending from it in the axial direction to the fastening element and/or close to it, the radial flexibility of the cartridge holder can be increased. This facilitates the radial expansion of the cartridge holder, while the cartridge interacts with the rigid fastening element, when the cartridge is inserted into the cartridge holder. When the head of the cartridge, for example, has passed the fastening element, the cartridge holder, due to its inherent elasticity, can return to its original undeformed shape and the fastening surface can be positioned so as to abut against the surface of the cartridge for fastening the cartridge inside the section holding the cartridge.

In one embodiment, the fastening element is formed as a single unit with a section or region of the cartridge holder. The section or region may form or shape at least one section of the outer surface or outer contour of the cartridge holder. Thus, the fastening element may be integrated into a region or section of the cartridge holder that defines the appearance of the cartridge holder.

Since the cartridge is conveniently permanently fixed in the cartridge holder, the cartridge assembly may form a single unit or a single unit of consumable material. In other words, the entire cartridge assembly may be a disposable part that is discarded after the drug or medicinal product contained in the cartridge has been dispensed and replaced with a new cartridge assembly.

If the cartridge is permanently fixed in the cartridge holder by a fastener, this leads to several advantages. For example, the cartridge is always protected by the cartridge holder when the user manipulates the cartridge assembly. In this case, the risk of damage to the cartridge is significantly reduced compared to systems where the user has to replace the cartridge in the holder. Instead, in the proposed system, the entire cartridge assembly is replaced with a new cartridge assembly.

Moreover, since the cartridge assembly contains not only the cartridge but also other elements such as the cartridge holder, the cartridge can more easily be assigned a designation or code for use with a specific drive mechanism or housing for a drug delivery device, particularly without changing the design of the cartridge.

The assignment of a symbol or code may be carried out by means of elements provided on the outside of the cartridge holder, which may interact with elements provided in the housing in order to allow the attachment of the cartridge unit to the housing if the drive mechanism located in the housing corresponds to the cartridge unit or the medicinal product or medicinal preparation contained therein, or to prohibit the attachment if the wrong cartridge unit is used. Alternatively or in addition, additional information about the contents of the cartridge, such as the name of the active pharmaceutical ingredient, trade mark, etc., may be present on the cartridge holder.

Since the surface of the cartridge is located between two opposite ends of the cartridge, the disclosed idea can be easily applied to cartridges with different lengths. Accordingly, a group of cartridge assemblies containing at least two cartridge assemblies can contain two different cartridges with different lengths at the assemblies.

In one embodiment, the surface of the cartridge is located closer to the dispensing end than to the end opposite the dispensing end, i.e. to the proximal end. This facilitates the fixation of cartridges of different lengths in the cartridge holder and/or provides a fastening element in an area that is difficult to access from the outside, i.e. an area located further from the proximal opening or end of the cartridge holder than from the distal end of the cartridge holder. The surface of the cartridge can be located further from the proximal end than 2/3*L, 3/4*L, 4/5*L, where L is the total length of the cartridge. The length of the cartridge can be determined or formed by the distance between the proximal end of the cartridge and the distal end or dispensing end.

In one embodiment, the surface of the cartridge is a surface that limits the head portion in the axial direction, in particular in the proximal direction. The surface of the cartridge can extend along a circumference, for example in the form of a flange, along the entire circumference of the cartridge.

In one embodiment, the end of the cartridge opposite the dispensing end is closed by a movable stopper or plug. If the stopper or plug is displaced inside the cartridge toward the dispensing end, the drug or medicinal product can be dispensed from the cartridge, provided that there is a fluid communication between the inside of the cartridge and the outside environment, for example by means of a needle piercing a membrane. The stopper or plug can be retained inside the main part of the cartridge. Accordingly, since the surface of the cartridge with which the fastening element is to interact can be located in the head part, the main part of the cartridge can be designed freely, for example with regard to its length and/or diameter. This facilitates the fastening or fixation of cartridges of different volumes in the cartridge holder. The stopper or plug suitably hermetically closes the cartridge in the proximal direction. The movement of the stopper inside the main part can be limited. In other words, it cannot enter the narrow part and/or the head part.

In one embodiment, the fastening element projects from the inner wall of the cartridge holder, in particular in the radial direction. In this way, the diameter of the inner part of the cartridge holder can be reduced to a size that is smaller than the outer diameter of the cartridge and, in particular, the head part of the cartridge. The fastening element can be oriented in the radial direction or at an angle relative to the radial and axial direction.

In one embodiment, the cartridge holder is designed in such a way that the fastening element can be, preferably elastically, biased in the radial direction, for example relative to the rest of the cartridge holder. In this way, a section of the cartridge, in particular the head portion, can be reliably guided past the fastening element, thereby deflecting or biasing the fastening element in the radial direction, for example outward. After the head portion has passed the fastening surface, the fastening element can be biased back into its initial unbiased position, expediently due to its elasticity, and/or inward, and can then fasten or lock the cartridge inside the cartridge holder.

In one embodiment, the cartridge holder comprises a plurality of fastening elements with corresponding fastening surfaces arranged so as to abut against the surface of the cartridge, preferably against the same surface. The fastening elements may be distributed along the circumference, preferably uniformly.

In one embodiment, the fastening element has a proximal surface. The proximal surface may face away from the fastening surface. The proximal surface may be sloping and/or inclined relative to the axial and radial direction. The fastening surface may be oriented in the radial direction. The sloping proximal surface of the fastening element facilitates the directed movement of the cartridge along the fastening element and the displacement of the fastening element when the cartridge moves along the fastening element. The fastening surface preferably has a greater inclination relative to the main axis of the cartridge holder than the proximal surface and may extend perpendicularly relative to this axis.

In one embodiment, the fastening element is located in an area of the cartridge holder where the cartridge holder does not have an opening.

In one embodiment, the cartridge holder is closed in the transverse direction, circumferentially and/or radially in the region with the fastening element. Preferably, the cartridge holder is closed transversely and/or radially in the circumferential direction in the region of the fastening element, for example along the entire length of its circumference.

In one embodiment, the cartridge holder comprises a needle connector, preferably in the distal region, wherein the needle connector comprises a connecting element, such as a thread or other connecting means, wherein the connecting element is suitable for connecting the needle assembly to the cartridge holder or is configured to connect. The needle assembly may comprise a cannula and a needle that is held by the cannula. The needle may be attached to the cannula and protrude distally from the cannula. The proximal end of the needle may be designed to penetrate the membrane of the cartridge. The needle may be made of metal or steel and the cannula may be made of plastic. When the needle assembly is attached to the needle connector, the needle may pass through the distal opening of the cartridge holder to the membrane of the cartridge and penetrate the membrane to create a fluid communication with the interior of the cartridge. Then, a dose of the drug or the drug may be dispensed from the interior of the cartridge through the needle.

In one embodiment, the distal end wall forms a central opening or a hole for a needle. The distal end wall can extend along a circle or at an angle around this opening. The opening for the needle can be connected to the opening of the distal end wall or in the distal end wall. Accordingly, it is easier to manufacture the cartridge holder by injection molding, since one continuous element can be used that forms both openings, i.e., the opening for the needle and the opening of the distal end wall corresponding to the position of the fastening surface.

In one embodiment, the cartridge holder is an injection molded part and the sprue mark is located on the distal end of the cartridge holder, in particular on the distal surface of the distal end wall.

The membrane is usually deformable, for example elastically deformable. Accordingly, if radial forces are transmitted to the cartridge while the membrane overlaps the fastening element in the axial direction, these forces may deform the membrane and/or the membrane retainer, which may be located between the membrane and the fastening element. Such forces may occur when the cartridge is moved in a direction past the fastening element and displaces the fastening element in the radial direction. Thus, if these forces act on the membrane, there is a risk of damage to the cartridge, for example due to deformation of the membrane retainer or removal of the membrane from the cartridge housing. Of course, this is undesirable, since the cartridge may be severely damaged if the forces act on the membrane or the membrane retainer. Accordingly, the cartridge and the cartridge holder are designed and adjusted relative to each other so that the fastening element is displaced only by a radial force applied by means of the cartridge if this element is in a certain position relative to the cartridge, which is displaced in the proximal direction relative to the membrane, i.e. when it overlaps a section of the cartridge body. Since the cartridge body is more rigid than the membrane, the entire cartridge is more rigid in that area and the risk of damage to the cartridge is significantly reduced.

In one embodiment, the cartridge holder comprises only one fastening element or a plurality of fastening elements. If there are a plurality of fastening elements, they are expediently uniformly distributed in the angular direction and/or located on one axis. Each of the fastening elements expediently has one fastening surface associated with it, which can abut against the surface of the cartridge. The angular extent of the corresponding fastening element or the fastening surface associated with it can be less than or equal to one of the following values: 20°, 15°, 10°.

In one embodiment, in the cartridge assembly, the distance between the cartridge surface and the mounting surface may be zero, i.e. the surfaces may abut each other, or may be greater than zero, such as less than or equal to one of the following values: 2 mm, 1 mm, 0.9 mm, 0.8 mm, 0.7 mm, 0.6 mm, 0.5 mm, 0.4 mm, 0.3 mm. This distance may determine the amount of movement in the axial direction that is possible in the cartridge assembly. In the case where the distance is not zero, this distance may be maintained by a deflecting element when the assembly is used in a drug delivery device.

In one embodiment, the cartridge assembly comprises at least one connecting element configured to be connected to a housing that can retain a drive mechanism, such as a threaded connection element or a bayonet connection element.

In one embodiment, the cartridge assembly comprises at least one coupling or coding element configured to interact with a corresponding coupling or coding element on the housing. The connecting element and the coupling or coding element may be formed by the same element or by different elements. Using the coupling or coding elements, it is possible to provide coding, so that the cartridge assembly can only be connected to the housing with the corresponding coding element. This increases safety for the user and ensures compliance of the drive mechanism designed to dispense a specific drug or medicinal product or specific amounts of drug or medicinal product, and the contents of the cartridge in the cartridge assembly. If the cartridge assembly and the drive mechanism do not match each other, the coupling or coding elements on the housing and the cartridge assembly are incompatible and the cartridge assembly cannot be connected to the housing to form a drug delivery device.

The terms "distal" and "proximal" as used herein may refer to opposite axial directions or ends. "Distal" may refer to the direction toward the dispensing end or the end of a component of a drug delivery device that is located or intended to be located closest to the dispensing end of a cartridge, cartridge assembly, or drug delivery device. "Proximal" may refer to the direction away from the dispensing end or the end that is located or intended to be located farthest from the dispensing end of a cartridge, cartridge assembly, or drug delivery device.

The terms "axial", "radial", "angular" or "azimuthal" as used herein may refer to the major longitudinal axis of a device, cartridge or cartridge assembly, such as the axis passing through the proximal and distal ends of a cartridge assembly, cartridge or drug delivery device.

The characteristic features disclosed above in combination with the cartridge assembly or the drug delivery device should not be regarded as relating only to the mentioned aspect or embodiment. Instead, the characteristic features are also applicable to other embodiments or aspects. The characteristic features disclosed in combination with the assembly are also applicable to the device and vice versa. Of course, the characteristic features disclosed in the specific embodiments described above or below can also be used in combination with each other and/or with other characteristic features of other embodiments.

Additional features, advantages and preferred embodiments of the present invention will become apparent from the following description of illustrative embodiments taken in conjunction with the accompanying drawings.

Fig. 1A-1F illustrate an embodiment of the cartridge assembly based on the schematic perspective view in Fig. 1A and the schematic sectional view of the assembly in Fig. 1B, and different views of the cartridge holder without the cartridge housed therein in Fig. 1C-1F. Fig. 1A-1F and their descriptions are disclosed in European Patent Application No. 18305975.7.

Fig. 2A-2D show schematic cross-sectional views of the cartridge assembly for the purpose of illustrating the technical problem on which the present invention is based and the various load paths that may occur on the cartridge holder.

Fig. 3A and 3B show a schematic 3D view and a schematic sectional view of a section of the flexible lever cartridge assembly.

Fig. 4A-4C show schematic 3D views and a schematic sectional view of a section of a distal portion of a cartridge assembly according to a first embodiment of the present invention.

Fig. 5A and 5B show a schematic sectional view and a schematic 3D view of a distal portion of a cartridge assembly according to a second embodiment of the present invention.

Fig. 6A-6C are schematic views of a distal portion of a cartridge assembly according to a first or second embodiment of the present invention.

Fig. 7A and 7B show schematic views of preferred embodiments of the contact surface of the fastener.

Fig. 8A and 8B show schematic 3D views of the distal region and the fastener.

Fig. 9A-9C show schematic cross-sectional views of embodiments that maintain seal integrity.

Fig. 10 shows a schematic view of an embodiment of a preferred form of fastener.

Fig. 11A and 11B show schematic views of the distal portion of the cartridge and the cartridge holder with a portion with increased rigidity.

Fig. 12 shows an embodiment of a drug delivery device with a cap that closes the distal end of the device prior to the dose setting operation.

Fig. 13 shows the device of Fig. 5 where the cap has been removed to expose the distal end of the cartridge assembly.

Identical elements, elements of the same type and elements of the same action may be designated by the same reference numbers in all figures.

Next, in combination with the drawings, several embodiments of cartridge assemblies with fasteners integrated into the cartridge holder of the assembly are disclosed. Before specific details of the embodiments are disclosed, features applicable to all embodiments are described. Each of Figs. 1A-1F shows one embodiment of the cartridge assembly 300.

The cartridge unit 300 comprises a cartridge 301 and a cartridge holder 302. The cartridge 301 is located inside a cartridge retaining or holding section 303 of the cartridge holder. The cartridge retaining section is expediently limited by an inner wall 304 of the cartridge holder 302, preferably along the circumference. The cartridge holder 302 comprises an opening 305. The opening 305 is expediently a proximal opening. The proximal opening can provide access to the interior of the cartridge holder from the proximal end of the holder. By means of the opening 305, the cartridge 301 can be inserted into the cartridge holder. The dispensing end 306 of the cartridge can be inserted or introduced into the cartridge holder through the opening 305. The opposite end of the cartridge holder is the distal end of the cartridge holder 302, which can be the end located closest to the dispensing end 306 of the cartridge 301. The distal end of the cartridge holder is preferably designed in such a way as to retain the cartridge in the holder, for example by means of a stop, so that the cartridge can exit the cartridge holder only through the opening 305. The extension in the axial direction of the cartridge holder is expediently selected in such a way as to cover at least 50%, preferably more than 60% or more than 70%, for example more than 80% or more than 90% of the total length of the cartridge. The entire cartridge can be covered by the cartridge holder 302, as shown in the embodiments.

The end of the cartridge opposite the dispensing end 306, i.e. the proximal end, is not explicitly shown in the figures. This end may be closed by a movable stopper or plug, which is also not explicitly shown. The stopper or plug may hermetically close the proximal opening of the cartridge. The drug 307 or the drug preparation is contained in the region of the cartridge located between the dispensing end and the stopper. The drug can be dispensed through the dispensing end 306 from the cartridge if a fluid communication is provided between the interior of the cartridge and the surrounding space and the stopper is moved to the dispensing end. The amount of drug 307 in the cartridge is preferably sufficient for a plurality of doses, wherein the dose size can be set by the user or can be fixed, for example by means of the design of the drive mechanism used to deliver the drug from the drug delivery device that contains the cartridge.

On the side of the dispensing end 306, the interior of the cartridge, which holds the medicament or medicament 307, is hermetically sealed by a membrane 308. The membrane 308 can be held in the cartridge housing 340 or can be fixed relative to it by means of a membrane retainer 309. The membrane 308 can be expediently pierced, for example by a needle, which can provide a fluid communication between the interior of the cartridge and the external environment. The membrane retainer 309 can be formed by a cap, for example a metal cap, such as an aluminum cap. The metal cap can be attached to the cartridge housing 340 by means of a clamp or crimping. The cartridge housing can be made of glass. The housing 340 can define an external contour of the cartridge. In the region of the dispensing end 306, where the needle must pierce the membrane, an opening is provided in the membrane retainer 308 in order to allow the needle to pass through the region of the membrane retainer. The cartridge 301 comprises a head portion 310 and a main portion 311. The head portion 310 is located on the side of the dispensing end 306. The main portion 311 can be located closer to the proximal end of the cartridge than the head portion 310. Between the head portion 310 and the main portion 311, a narrow portion 312 can be located. The main portion 311 can be an area where a stopper or plug can move. The main portion has a tubular configuration. The narrow part 312 can have a reduced diameter, with respect to the outer and/or inner diameter, compared to the main part 311. The head part 310 has a reduced diameter, with respect to the outer and/or inner diameter, compared to the main part 311. The narrow part 312 has a reduced diameter compared to the main part, and also compared to the head part 310. The diameter can be the extension of the cartridge 301 in the direction perpendicular to the main longitudinal axis of the cartridge or cartridge assembly, passing between the proximal end and the distal end. The narrow part can extend along the circumference. The entire cartridge 301 can have rotational symmetry about the main longitudinal axis. The transition between the head portion 310 and the narrow portion 312 can be formed by a comparatively steep surface, which is preferably less inclined relative to the radial direction than the surface located between the narrow portion 312 and the main portion 311. Accordingly, the transition between the narrow portion 312 and the main portion 311 can be less steep than the transition between the head portion 310 and the narrow portion 312. In particular, the surface 313 of the cartridge, which can limit the head portion 310 in the proximal direction, can have an inclination relative to the radial direction, which is less than the inclination of the surface 314 of the shoulder, which limits the main portion in the distal direction. The surface of the cartridge can be formed by the membrane retainer 309 or, alternatively, by the cartridge body 340. The membrane retainer 309 can attach the membrane to the cartridge body by means of a clamping action. Thus, the membrane retainer can extend from the distal end along the cartridge to the surface of the narrow part of the cartridge body facing away from the distal end of the cartridge and extending in the radial direction, in order to attach the membrane 308 to the cartridge body by means of a clamping action. The cartridge can contain or consist of a cartridge body 340, a membrane 308, a membrane retainer 309, a drug or a drug preparation 307 and/or a plug (not explicitly shown).

The cartridge holder 302 comprises a distal end wall 315 at the end opposite the opening 305 and/or closest to the cartridge dispensing end 306, i.e. at its distal end. The distal end wall can extend along a circumference, like a ring. The proximal surface of the distal end wall 315 is arranged so as to abut the distal end surface of the cartridge 301. Thus, the cartridge 301 can be retained in the cartridge holder without moving in the distal direction relative to the cartridge holder 302. The distal end wall 315 can form an opening 316 in the cartridge holder. The end wall can extend around the opening, as a result of which the opening is a central opening in the end wall. The opening may extend axially through the end wall 315. The opening 316 may be designed in such a way that the needle can be guided through the opening toward the cartridge, in particular toward the membrane 308.

The cartridge holder 302 may comprise a distal region 317 and a region 318 of the main part. The distal region 317 is located closest to the end of the cartridge dispensing and/or to the distal end wall 315 of the cartridge holder. The region 318 of the main part is located further from the distal end or the distal end wall 315 and/or closer to the opening 305 than the distal region. Compared to the region of the main part, the distal region may have a reduced outer diameter. This reduction may be determined by a reduced diameter of the head compared to the diameter of the main part of the cartridge. The region 318 of the main part and the distal region may be connected by an inwardly directed shoulder region 331. A needle connector 319, such as a thread, may be located in the distal region. A needle assembly, such as a cannula of the needle assembly, may be attached to the cartridge holder 302 by the needle connector. A needle held in a cannula may be directed through an opening 316, pierce a membrane 308 and provide fluid communication with the interior of the cartridge for dispensing a drug 307 or a drug from a cartridge 301. A distal region 317 may be configured to receive a head portion 310 of a cartridge 301 within it. A region 318 of the main part may be configured to receive a main part 311 of a cartridge therein. On the proximal end side, the cartridge holder may have a connecting or mating region 320. In this region, connecting or mating elements may be provided that are configured to interact with corresponding elements on the housing 10 in order to attach the cartridge assembly 300 to the housing to form the drug delivery device 1 (see Figs. 12 and 13). The connecting elements may be designed for a threaded or bayonet connection between the cartridge holder and the housing. Preferably, the connecting or coupling elements have a coding corresponding to a housing containing an actuating mechanism designed for a drug or a medicinal product contained in a cartridge of the cartridge assembly. The coding ensures that only the correct cartridge assembly can be connected to the housing to form a drug delivery device. In this way, it is possible to ensure that the drug contained in the cartridge assembly is dispensed by an actuating mechanism that is specifically designed to dispense the contents of the cartridge. The actuating mechanism may comprise a piston rod arranged so as to drive a plug or stopper in a distal direction relative to the cartridge, thereby dispensing the drug or medicinal product from the cartridge.

A step 321 or flange projecting in the radial direction outward can be provided between the proximal end and the distal end of the cartridge holder 302, preferably closer to the proximal end than to the distal end. The step or flange 321 can extend along the entire circumference of the cartridge holder 302. The proximal surface of the step 321 can be positioned so as to contact the distal surface of the housing when the cartridge assembly is connected to the housing. The connecting region 320 can be closed by the housing when the assembly is connected to the housing. However, the region 318 of the main part and the distal region 317 can protrude from the housing.

In addition, the cartridge holder 301 comprises at least one fastening element 322. As seen along the axial direction, the fastening element 322 is provided between two inner regions of the cartridge holder, where one is adapted to accommodate and hold the head portion 310 and the other is adapted to accommodate and hold the main portion 311 of the cartridge. The fastening element 322 can extend in the region of the narrow part of the cartridge 301. The fastening element 322 projects in the radial direction from the inner wall of the cartridge holder 301. Preferably, the fastening element 322 reduces the inner diameter of the cartridge holder so that in that region the inner diameter is smaller than the outer diameter of the head portion of the cartridge.

Therefore, if the head part of the cartridge is to be directed along the axis past the fastening element from the proximal opening, the fastening element must be deflected outward in the radial direction, for example displaced only in the radial direction. If the fastening element is deflected, the head part can pass the fastening element. Preferably, the fastening element is deflected by means of the head part interacting with the proximal surface of the fastening element, which can be inclined, i.e. not perpendicular and not parallel, relative to the main axis of the cartridge holder. After the head part has passed the fastening element, the fastening element can again move inward in the radial direction, for example elastically. The inner region of the cartridge holder, designed to accommodate the head part 310, can have a reduced diameter compared to the region in which the main part 311 is accommodated.

The fastening element 322 is formed as a single unit, for example by injection molding, with a section of the cartridge holder, which forms an outer surface or at least an outer contour of the cartridge holder. In other words, if applicable, the outer surface of the cartridge holder can be provided with a coating, while the outer contour can still be formed by a section of the cartridge holder, in which the fastening element is integrated. In Fig. 1A-4A, a sprue mark 323 is shown, which denotes a position in which a flowable plastic composition is injected into a mold cavity defining the geometric shape of the cartridge holder. The sprue mark 323 can be located in the region of the distal end wall 315 of the cartridge holder, in particular on the distal surface of the distal end wall.

The fastening element 322 comprises a fastening surface 324. The fastening surface 324 may be a distal surface of the fastening element. Preferably, the fastening surface is oriented in the radial direction, i.e. it extends in the radial direction and/or plane. The fastening surface 324 is arranged so as to abut, or abuts, a surface of the cartridge facing in the proximal direction, such as the surface 313 of the cartridge. Thus, the surface 313 of the cartridge and the fastening surface 324 are arranged so as to prevent the removal of the cartridge in the proximal direction from the cartridge holder through the opening 305 by means of mechanical interaction with each other. Accordingly, the removal of the cartridge from the holder through the opening 305 is prevented by means of the fastening element 322. The fastening element 322 can be made in the form of a latch and/or a bracket. The angular extent of the fastener or fastening surface may be less than or equal to one of the following values: 20°, 15°, 10°, in alternative embodiments, equal to or greater than 20°, such as 30°, 35°, 40°, 45°, 50°, 55° or 60°. For example, the angular extent may be from 10° to 60°.

In addition, the outer wall of the cartridge holder is provided in the axial position of the fastening element. Thus, the cartridge holder is closed at least in the area of the fastening element. Accordingly, the fastening surface and/or the fastening element cannot be accessed from the outside. This reduces the chances of unauthorized actions with the cartridge unit.

An embodiment of a cartridge holder with a fastening element integrated in the cartridge holder is described in more detail below. The embodiment shown in Figs. 1A and 1B comprises one fastening element 322, in particular a single fastening element. Of course, a plurality of fastening elements can also be provided.

The fastening element 322 projects in the radial direction from the inner wall 304 of the cartridge holder 302. The fastening element 322 is located inside the distal region 317 of the cartridge holder 302 and, in particular, in the inner region of the cartridge holder, where the needle connector 319 is provided on the outside. As can be seen in Fig. 1A, as well as in Fig. 1B, the distal end wall 315, which has a generally annular configuration, contains an opening 325. The opening 325 is oriented in the radial direction and interrupts the ring formed by the distal end wall 315. The opening 325 extends in the radial direction outward from the opening 316. The angular and radial position of the opening 325 can correspond to the fastening element 322 or to the fastening surface 324, where the opening is offset in the axial direction from the fastening element, for example in the distal direction. In particular, as seen from the distal end along the axis, the fastening surface can be visible from the distal end. The fastening surface can be framed in the radial and angular directions by side walls that define the opening 325. In the figures, the head part 310 of the cartridge 301 is located between the opening 325 and the fastening surface 324. The angular size and/or the radial size of the opening 325 can form the angular size and/or the radial size of the fastening surface and/or the fastening element, and can also correspond to them or can exceed them. Providing an opening in the region of the distal end facilitates molding a cartridge holder with an integrated fastening element using only minor modifications to the mold or molding tool compared to a cartridge holder without fastening elements. In a cartridge holder without a fastening element, two design pins with different diameters can be used to manufacture the cartridge holder by injection molding, wherein one design pin forms the inner part of the distal region and one design pin forms the inner part of the region 318 of the main part of the cartridge holder. The short design pin can form the inner part in the distal region and the long design pin can form the region of the inner part in the region of the main part. The fastening element 322 can be built directly at the intersection or border of two different design pins of the injection molding tool. The opening 325 can be formed during the casting process and facilitates casting of the cartridge holder with the fastening elements 322 built into it. The opening 325 can be formed by a projection, for example made of metal, on the short design pin.

In the region where the fastening element 322 is provided, for example in the distal region 317, the cartridge holder 301 may have the ability to deform in the radial direction. Thus, the inner diameter may be increased when the cartridge holder 302 is subjected to a force directed outward in the axial or radial direction. The ability of the cartridge holder 302 to deform in the radial direction when subjected to a radially directed force may be increased in that angular section of the distal region 317 that overlaps the opening 325 at an angle. The fastening element 322 is located in this region since it overlaps the opening at an angle. The fastening element is expediently not flexible and/or rigid, for example more rigid than the distal region 317 or the inner wall of the first region where the head part of the cartridge is to be located. Thus, when an axial and/or radial force acts on the fastening element 322, for example when the head portion is guided along the fastening element 322 and comes into contact with it, the cartridge holder 302 expands due to the rigidity of the fastening element 322. The fastening element 322 itself does not deform or bend, or at least deforms only slightly compared to that part of the cartridge holder that is deformed, for example the distal region 317 or the shoulder region 331. Since the cartridge holder 302 is expediently made of plastic, a very limited deformation of the fastening element itself cannot be avoided. However, in the proposed concept, it is the expansion of the cartridge holder in the circumferentially closed region of the cartridge holder 302 that facilitates the insertion of the cartridge into the cartridge holder. The cartridge holder is deformed when the cartridge is inserted into the cartridge holder. The deformable region expediently represents a region that does not contain flexible levers, projections or tongues. The fastening element 322 is used to transmit the force of inserting the cartridge to the cartridge holder in order to expand the cartridge holder in the transverse direction. The inner part of the cartridge holder expands in the area of mechanical contact between the cartridge and the cartridge holder, i.e. in the area in which the fastening element is located, and preferably in the areas located adjacent to it in the axial direction and/or along the circumference. In contrast to the deflection of individual flexible levers, projections or tongues, the expansion of the inner part of the cartridge holder can provide a more stable fixation of the cartridge in the cartridge holder after the cartridge is inserted into the cartridge holder. After the head part 310 has passed the fastening element 322, the fastening element is again displaced inward, for example due to the fact that the deformation is an elastic deformation, and the surface 313 of the cartridge and the fastening surface 324 are located as shown in Fig. 1B. The fastening element is preferably not deformed or at least deformed slightly during this process and, in particular, is not deflected or rotated in the axial direction.

As shown in Fig. 1B, the inclined surface 326, which radially increases along its extension in the distal direction, is arranged with an offset in the distal direction relative to the fastening surface 324. Thanks to this surface, which is preferably arranged on the opposite side of the fastening surface or at least with an angular offset relative to the fastening surface, it is possible to ensure a movement in the radial direction of the head part 310 of the cartridge 301 to the region radially overlapping the fastening surface 324. In this way, the inclined surface plays the role of a cartridge guide element during the assembly of the cartridge unit 300. Therefore, references to the inclined surface 326 can be considered as references to the cartridge guide element, and vice versa. In this way, it is possible to increase the radial overlap of the fastening surface 324 and the surface 313 of the cartridge 301 when the cartridge has reached its final position. The sloping surface 326 can increase the stability of fixing the cartridge in the cartridge holder, for example in the case where only one fastening element is provided.

The offset in the distal direction (indicated by the letter "B" in Fig. 1B) of the element 326, the guide of the cartridge, from the fastening element, from the fastening surface 324 and/or the radial free end of the fastening element 322 can be greater than the thickness (indicated by the letter "A" in Fig. 1B) of the membrane 308 of the cartridge. This ensures that the membrane retainer 309 rests on the more rigid body 340 of the cartridge and preferably not on the membrane, when the cartridge interacts with the fastening element 322 to radially displace the element outward in order to temporarily expand the interior of the cartridge holder. In this way, the force required to displace the element 322 is not transmitted to the membrane. If the force were transmitted to the membrane, the risk of deformation of the membrane retainer 309, which can be a thin metal component, or the risk of damage to the membrane would be significantly increased. This can be prevented by a displacement in the distal direction between the cartridge guide element 326 and the fastening surface 324 by a distance exceeding the membrane thickness 308. The displacement in the distal direction B is expediently less than the extension in the axial direction of the head part 310 of the cartridge. In this way, the cartridge guide element can correctly guide the cartridge 301 radially inward by interacting with the head part 310.

In the region of the inner part of the cartridge holder 302 between the cartridge guide element 326 and the fastening surface 324, the inner diameter of the inner part of the cartridge holder may be larger than in the region of the cartridge guide element and/or in the region offset in the distal direction relative to the cartridge guide element, if such a region is present, although it may be both present and absent. In the region of the inner part of the cartridge holder between the cartridge guide element and the fastening surface, the inner diameter may be larger than the inner diameter in the region of the fastening element. In the region of the cartridge guide element 326 and/or in the distal direction relative to the cartridge guide element, the inner diameter of the cartridge holder may be larger than the inner diameter in the region of the fastening element, for example larger than or equal to the outer diameter of the head part 310.

In other words, the membrane retainer or metal sleeve 309 comprises a distal section surrounding the soft membrane 308 and a proximal section surrounding the narrow portion of the cartridge body or glass ampoule 340. It is advantageous if the distal section of the membrane retainer moves past the fastening surface 324 before the distal section contacts the cartridge guide element or the sloped surface 326. Thus, the radial overlap of the metal sleeve 309 and the fastening surface is minimal during the assembly period when the fastening surface can damage the metal sleeve 309, and this overlap only increases after the fastening surface moves past the distal section of the metal sleeve 309 and applies radial pressure to the proximal section. Since the proximal section rests on a harder material, such as glass, than the distal section, it will not be damaged or chipped. The final overlap between the mounting surface and the cartridge surface at the end of the assembly process is still high. The final overlap can be formed by a smaller inner diameter of the cartridge holder in the region of the sloped surface, which marks the end of the sloped surface 326.

When testing the cartridge holder 302 with the integral fastener 322, it was found that the distal section of the membrane retainer 309 is highly susceptible to denting unless the diameter in front of the sloped surface 326 is substantially larger than the diameter after the sloped surface 326, so that the cartridge 301 can move away from the fastener with minimal or no interference in the distal section of the membrane retainer, and that this interference increases only after the fastener exerts pressure in the region of the membrane retainer 309, where the head of the cartridge body, for example made of glass, supports/supports the membrane retainer, which may be a thin and easily deformed metal component.

When the cartridge 301 is installed in the cartridge holder 302, the fastening element 322 can block the movement in the proximal direction of the cartridge 301 relative to the holder 302. However, the fastening element expediently does not apply a locking force, for example in the distal direction or a radially directed force, to the cartridge in a regular manner, but only prevents the cartridge from being removed from the cartridge holder. Thus, the force load on the cartridge can be advantageously low.

In Fig. 1C-1F additional views of the cartridge holder 302 are shown. In Fig. 1C a view from the distal end is shown. As can be seen immediately, the angular dimension of the fastening element 322 is smaller than the angular dimension of the opening 325. The radial dimension of the fastening element 322 or the fastening surface is also smaller than the radial dimension of the opening 325. In Fig. 1D, also showing the distal end, but in perspective, it is shown that the cartridge holder, in particular the distal region 317, is reinforced, i.e. has an increased strength or wall thickness, in the region located adjacent to the fastening element 322 at an angle to it. The reinforcing section 341 extends along the circumference in the inner part of the cartridge holder. The reinforcing section can overlap the fastening element in the axial direction. Alternatively or additionally, the reinforcing section 341 may be positioned with an offset in the distal direction relative to the fastening element 322. In the region of the inner part of the cartridge holder, which overlaps the fastening element in the angular direction, the reinforcing section is preferably interrupted in order to facilitate the radial deformability of the cartridge holder when the head portion offsets the fastening element 322 in the radial direction.

As can be seen from the opening 325 in the axial direction to the fastening surface 324, the wall thickness of the holder 302 can be less than the wall thickness in the reinforcing section 341. The wall thickness of the cartridge holder 301 in the region of the fastening element 322 and formed by the fastening element can be greater than the wall thickness in the reinforcing section 341. The fastening element 322 can protrude in the radial direction over the reinforcing section 341. The reinforcing section 341 is also shown in Fig. 1F, which shows a perspective view in section of the cartridge holder 302. In this figure, as well as in Fig. 1E, which shows a view from the proximal end of the cartridge holder 302, it is shown that the inner part of the cartridge holder comprises a plurality of separating elements or elements 342 for supporting the cartridge, such as ribs, arranged along the circumference, preferably at regular intervals. These elements 342 are oriented in the axial direction. These elements 342 can be provided to support the cartridge in the radial direction, for example to support its main part 311, if the cartridge is held in a cartridge holder. These elements can be the only difference between a cartridge holder that accommodates cartridges with a smaller diameter and a cartridge holder that accommodates a cartridge with a larger diameter. A cartridge holder for a cartridge with a larger diameter may expediently not contain elements 342 for supporting the cartridge. Thus, the external dimensions of the cartridge holder can be unchanged, although the external diameters of the cartridges held in the cartridge holders are different.

As can be seen in the figures, for example in Fig. 1B, the needle connector 319, for example the thread, is offset in the distal direction relative to the fastening element 322. In particular, the region between the fastening element and the cartridge guide element or the sloped surface 326 may not contain the needle connector 319. The needle connector may overlap in the axial direction the cartridge guide element 326, or may be offset in the distal direction relative to this element 326. Thus, the extension in the axial direction of the needle connector 319 may be smaller than in other designs of the cartridge holder. For example, the needle connector 319 may be limited to the distal section of the distal region 317 of the cartridge holder, where between the needle connector 319 and the region of the main part there is a region without a connector. The extension in the axial direction of the region without a connector may exceed 50% of the extension in the axial direction of the distal section with the needle connector. The axial extension of the distal section with the needle connector may be greater than the axial extension of the region without the connector. Since the cartridge holder in the region between the fastening element 322 and the guide element 326 has a reduced wall thickness to increase the inner diameter of the cartridge holder 302, for example to maintain a given outer contour or size of the cartridge holder 302, providing an additional radial recess on the outer side of this region, which may be required by the connector 319, will increase the risk of damaging the cartridge holder in this region or even make it impossible to mold it. Thus, a shortened needle connector is advantageous.

Although only one fastener is shown in the illustrated embodiment, the sloping surface can also be provided in the case of using a plurality of fasteners. However, in the following embodiment, the sloping surface is not shown.

Fig. 2A-2D show cross-sections of cartridge 301 and cartridge holder 302 and various load paths that may occur within cartridge holder 302 as cartridge 301 is moved in a distal or proximal direction.

As described above, in the region where the fastening element 322 is provided, for example in the distal region 317, the cartridge holder 301 may be able to deform in the radial direction. In this way, the inner diameter may be increased when the cartridge holder 302 is subjected to a force directed radially outward. When an axial and/or radial force acts on the fastening element 322, for example when the head portion is guided along the fastening element 322 and contacts it, the cartridge holder 302 expands due to the rigidity of the fastening element 322. After the head portion 310 has passed the fastening element 322, the fastening element is again displaced inward, for example due to the fact that the deformation is an elastic deformation, and the surface 313 of the cartridge and the fastening surface 324 are located as shown in Fig. 1B.

Disassembly of the cartridge 301 due to opening or impact is likely to result in movement of the cartridge 301 in the proximal direction relative to the cartridge holder 302. In this situation, the surface of the membrane retainer 309 facing in the proximal direction may contact the fastening element 322 and apply a load to the cartridge 301, generally directed in the proximal direction. This load may result in deformation of the cartridge holder 302. The fastening element 322 may bend in the proximal direction.

However, the fastening element 322 may also bend in a radial direction either inward or outward, approximately in the direction of the Y-axis oriented perpendicular to the distal and proximal direction, see the dashed line with an arrow in Fig. 2A. The bending of the fastening element 322 may not exactly follow the specified direction of the Y-axis, but is generally directed inward or outward relative to the longitudinal axis of the device.

This deviation in the radial direction of the Y-axis affects the strength of the fixation. In the situation with radial outward bending along the Y-axis, as the load increases, the radial engagement of the fastener 322 with the membrane retainer 309 will decrease. If the load is high enough, the engagement will decrease to the point at which the membrane retainer 309 passes behind the fastener 322 and/or the fastener 322 deforms plastically to provide the ability to disassemble the cartridge 301. In addition, the membrane retainer 309 will likely have a rim on its outer edge that will come into contact with the fastener 322 at some point as the engagement decreases, which will facilitate the disassembly process. The result will likely be low strength of the fixation. In the situation with radial inward bending, as the load increases, the radial engagement of the fastener 322 with the membrane retainer 309 will increase. The behavior will therefore be "self-locking" and this will tend to provide a greater locking force. In addition, the locking strength is likely to be less sensitive to the size of the initial engagement and, as a result, will be less likely to vary due to tolerances of the cartridge 301 or the cartridge holder 302.

The radial inward or outward deflection of the fastening element 322 in the Y-axis direction depends on the load path passed by the load applied to the fastening element 322 by the cartridge membrane retainer 309. As an example, in Fig. 2B, three possible load paths are indicated: the distal load path DLP, the circumferential load path CLP and the proximal load path PLP inside the cartridge holder 302. The magnitude of the load passed along each load path DLP, CLP, PLP will depend on the stiffness of the corresponding load path DLP, CLP, PLP, whereby a load path with a higher stiffness absorbs more load than a load path with a low stiffness.

When the cartridge 301 is inserted into the opening 325 of the cartridge holder 302 in the distal direction, at some point the most distal surface of the cartridge 301 passes beyond the fastening element 322.

By means of the opening 305 the cartridge 301 can be inserted into the cartridge holder. The dispensing end 306 of the cartridge can be inserted or introduced into the cartridge through the opening 305. The opposite end of the cartridge holder is the distal end of the cartridge holder 302, which can be the end located closest to the dispensing end 306 of the cartridge 301. The distal end of the cartridge holder is preferably designed in such a way as to retain the cartridge in the holder, for example by means of a stop, so that the cartridge can exit the cartridge holder only through the opening 305.

If the cartridge 301 is inserted completely into the cartridge holder, so that the distal end of the cartridge holder 302 is closest to the cartridge dispensing end 306, the distal end of the fastening element 322 holds the cartridge 301 in the holder. During insertion, the cartridge 301 passes the fastening element 322 and applies a distal load to the fastening element 322. This results in a distal load path DLP and a circumferential load path CLP, which also acts in the distal region 317. When moving the cartridge 301 from the holding position in the proximal direction, the cartridge 301 applies a force to the fastening element through the membrane retainer 309, which results in a proximal load path PLP. The membrane retainer 309 then acts in a proximal direction toward the fastener 322, which results in a load and a proximal loading path PLP, as indicated in Fig. 2B.

Each DLP, CLP, PLP loading path will tend to produce a different deflection mode. Two key DLP, PLP loading paths with very different deflection modes are shown separately in Fig. 2C and 2D.

As shown in Fig. 2C, the distal DLP load path is prone to result in radial outward bending of the fastener 322, as indicated by the dashed arrow.

As shown in Fig. 2D, the proximal PLP load path tends to result in radial inward bending of the fastener, as indicated by the dashed arrow.

Distal DLP, CLP loading paths will tend to create radial outward deflection, whereas proximal PLP loading paths will tend to create radial inward deflection.

Fig. 3A and 3B show a schematic 3D view and a sectional view of a cartridge and a cartridge holder with a flexible lever as known in the art.

The flexible arm 345, which extends into the distal region 317 of the cartridge holder 302, can be used to create a self-locking. The flexible arm 345 extends in the proximal direction into the shoulder region 331. The flexible arm 345 is fixed in the shoulder region 331 and is flexible in the radial inward and outward direction. The flexible arm 345 is bordered by a u-shaped hole 347. However, this approach has certain disadvantages. Firstly, its function as a fastening element of the cartridge is obvious to an observer looking at the outer surfaces of the part. Secondly, it is accessible for manipulation with a tool with a narrow profile, such as a screwdriver. Thirdly, it has limited radial rigidity due to the inherent flexibility of the flexible arm 345. This makes it easier to manipulate the flexible arm 345, so that it no longer holds the cartridge 301 effectively.

Fig. 4A-4C are schematic 3D views and a sectional view of a distal portion of a cartridge holder according to a first embodiment of the present invention.

Fig. 4A shows a schematic sectional view of the distal region 317 and a portion of the region 318 of the main part of the cartridge holder 302, as well as a cartridge 301 received in the cartridge holder 302. Between the distal region 317 of the cartridge holder 302 and the region of the main part 318, a shoulder region 331 is located.

Adjacent to this shoulder region 331, there is a region with reduced mechanical rigidity 350, which is positionally fixed and contains a cutout. The purpose of the region with reduced mechanical rigidity 350 is to reduce or eliminate the load arising from the cartridge 301 in the direction to the fastening element 322 through the distal path DLP, CLP of loading when moving the cartridge 301 in the proximal direction, and as a consequence, its tendency to bend radially outward. This, as a consequence, increases the magnitude of the load passing through the proximal path PLP of loading with the associated radial deviation inward. The region with reduced mechanical rigidity 350 in this embodiment contains a cutout. Adding the cutout provides self-locking and significantly increases the strength of the fixation.

Additionally, by reducing or eliminating the distal DLP, CLP loading paths, the rigidity of the cartridge holder 302 in response to proximal loading from the cartridge 301 is reduced. This means that during an impact loading scenario, the forces generated will also be reduced by absorbing the impact energy over a longer deflection distance. This also tends to increase the strength of the fixation.

The cutout can extend radially through the side wall of the cartridge holder, in particular through the entire side wall, from the outer part of the cartridge holder to the inner part of the cartridge holder. The cutout can be located in the distal region of the cartridge holder and/or limited by this region. The cutout can extend and/or be oriented in the circumferential direction, for example in the form of a slot. The cutout can be arranged parallel to the connecting element, which can be a thread. The cutout in the side wall of the cartridge holder can be formed by a molding tool, which during production can abut, in particular radially, against the outer surface of a molding pin of the molding tool, wherein the molding pin forms the inner part of the cartridge holder in the region in which the opening is located, for example in the distal region. In this way, without replacing the molding pins, a fastening element can be formed for the inner part of the cartridge holder.

The present invention thus represents an improvement over what is known in the art in terms of tamper resistance to prevent unauthorized disassembly of the cartridge 301, since the fastening element is less visually noticeable and less accessible to manipulation with tools.

Fig. 4B shows a schematic 3D view of the distal region 317 of the cartridge holder 302, the shoulder region 331 and a small section of the main part region 318. Also shown is a region 350 with reduced rigidity adjacent to the shoulder region 331 in the distal direction.

Fig. 4C shows a schematic 3D longitudinal sectional view of the cartridge holder 302.

Fig. 5A shows a schematic cross-sectional view of a section of each of the distal region 317, a portion of the region 318 of the main portion of the cartridge holder 302, and a cartridge 301 housed in the cartridge holder 302.

The magnitude of the load passing through each loading path DLP1, DLP2, PLP depends on the stiffness of the loading path. A loading path with a higher stiffness absorbs more load than a loading path with a low stiffness. Adjustment of the stiffness value can be achieved by changing the size and depth of the cutout, located similarly to the cutout in the previous embodiment. This area with reduced stiffness can take various forms and involve profiling of both the inner and outer surfaces, equally with the cutout or instead of it. A simple example uses a reduced wall thickness, which can have the form of a groove.

An additional advantage of this design is that the resistance to opening according to this method of fixation is further increased, since manipulation of the fastening element from the outside is made even more difficult due to the lack of a cutout.

Fig. 5B shows a schematic 3D view of the distal region 317, the shoulder region 331 and a section of the region 318 of the main part of the cartridge holder 302. In the distal region 317, a region with reduced rigidity 350 in the form of a rectangular groove is shown. The groove is located near the shoulder region 331. The longer side of the rectangle runs parallel to the shoulder region.

Fig. 6A-6C show schematic sectional views of the distal region 317 of the cartridge holder 302 according to the first or second embodiment of the present invention. Several examples of possible shapes of the cutout are shown, which can be rectangular with or without rounded edges. These examples are not exclusive, other shapes are also possible, such as a circular or triangular shape, which form a region of reduced rigidity, which leads to the desired load path.

In Fig. 7A-7B schematic views of preferred embodiments of the contact surface of the fastening element are shown.

This concept also includes several additional elements that serve to improve

self-locking.

The fastening surface 324 of the fastening element 322 may be a convex curve so that the contact with the retainer 309 of the cartridge membrane will preferably be made in the center of the fastening surface 324. This is shown in the schematic sectional view in Fig. 7A. This may provide improved self-locking.

Alternatively, as shown in the sectional view of the fastening element 322 and the section of the membrane retainer 309 in Fig. 7B, the fastening surface 324 can be inclined so that the contact of the cartridge membrane retainer 309 occurs predominantly on the radially inner edge of the fastening element 322. This can provide improved self-locking. Additionally, the geometric properties of the membrane retainer 309 tend to be more uniform with a smaller radius, providing improved consistency of behavior.

Fig. 8A and 8B show schematic 3D views of the distal region 317 and the fastener 322 where a pocket of material has been removed in the region radially outside the fastener 322.

This can provide improved self-locking. An additional advantage of the cutout is that the force required to assemble the cartridge into the cartridge holder 302 is reduced due to the increased flexibility of the fastener provided with the cutout.

Fig. 9A-9C show schematic cross-sectional views of embodiments that maintain seal integrity.

In the 1.5 ml and 3 ml cartridges 301, the membrane retainer 309 is supported over a portion of its length by the membrane 308 and over a portion of its length by the cartridge glass. High radial contact pressures applied to the area supported only by the membrane 308 are more likely to result in a seal integrity failure than contact pressures applied to the area supported by the cartridge glass, since the membrane 308 is softer and also represents a component that provides a seal interface.

To eliminate this risk, the internal channel of the needle connector of the cartridge holder provides a first 328 and a second 329 internal diameter with a conical surface connecting them together. The first internal diameter 328 can be larger than the second internal diameter 329, while the second internal diameter 329 can be located distally from the point of view of the first internal diameter 328.

This geometry is designed to reduce the interference between the membrane retainer 309 and the fastener 322 when the fastener 322 contacts the area of the membrane retainer 309 supported by the membrane 308, reducing the likelihood of damage to the integrity of the seal.

Since the membrane retainer 309 is supported by the glass, the membrane retainer 309 moves to create contact with the conical surface, now increasing the interference, when the membrane retainer 309 can better resist deformation. Towards the end of the assembly stroke and in the completed assembled state, the membrane retainer 309 contacts the area with a smaller diameter 329, thereby providing greater interference and, as a result, the strength of the fixation. This design, as a result, provides greater interference during assembly, which is likely to improve the strength of the fixation, while minimizing the risk of compromising the integrity of the seal.

Fig. 9A shows step 1 of the assembly process. When the cartridge 301 is inserted into the cartridge holder 302 through the opening 305 in the distal direction, at some point the distal portion of the cartridge 301 contacts the fastening element 322. The fastening element 322 is deflected outward, on the opposite side of the fastening element 322 inside the cartridge holder 302, the cartridge 301 slides along the inner side wall of the cartridge holder 302 and contacts the surface with a larger diameter 328, while the fastening element contacts the surface of the membrane retainer, which is supported by the membrane, which provides reduced tension and, as a result, contact pressure on the weaker part of the membrane retainer. Thus, on the opposite side of the fastening element 322 inside the cartridge holder 302, the cartridge 301 slides along the inner side wall of the cartridge holder 302.

Fig. 9B shows step 2 of the assembly process. As the cartridge moves further distally, the inner diameter of the cartridge holder 302 decreases, so that the cartridge 301 is forced into a press-fit type contact with the inner wall of the cartridge holder 302. The contact moves to a surface with a successively smaller diameter as the fastener contacts the surface of the membrane retainer supported by the cartridge glass, which gives a greater tension.

Fig. 9C shows step 3 of the assembly process. When the cartridge is moved further in the distal direction, the membrane retainer 309 passes completely behind the fastening element 322. The fastening element 322 is then deflected radially inward so that it abuts the cartridge 301 from moving in the proximal direction. The distal part of the membrane retainer 309 is covered from the cartridge holder 302 in the region with the inner smaller diameter 329.

Fig. 10 shows a schematic view of an embodiment of a preferred form of fastener 322.

As an additional element to reduce the peak localized contact pressure on the membrane retainer and the risk to the integrity of the seal, the fastening element is also profiled such that the tension peaks in the center of the element and decreases towards the edges.

Fig. 11A-11B show a schematic sectional view and a schematic 3D sectional view of the distal portion of the cartridge holder. Alternatively, the aim is to further increase the resistance to opening according to this method of fixation, since the manipulation of the fastening element from the outside is further complicated due to the absence of an opening. This can be achieved by including a region with increased stiffness 355 in the proximal loading path (instead of with reduced stiffness in the distal loading path). For example, the fastening element 322 can be thickened or contain an additional layer for locally increasing the stiffness.

Fig. 12 and 13 schematically illustrate embodiments of a drug delivery device suitable for use with the disclosed cartridge assembly. Fig. 12 illustrates the device 1 in a state in which the cap 120 is attached and covers the cartridge assembly 300. In Fig. 13 the cap has been removed. The cartridge assembly 300 is connected, expediently in a detachable manner, to a main part or housing 10 of the drug delivery device 1, as shown in Fig. 13. The housing expediently forms the outer contour of the device and may be in the form of a sleeve. The needle assembly may be connected to the needle connector 319 for dispensing a drug or a medicament from the device 1. The dose setting member 70 is movably retained in the housing 10 and may be manipulated by the user to set the dose. For example, it may be rotated relative to the housing to set the dose. The device may be a variable dose device, where the dose size is not predetermined by the design of the drive mechanism retained in the housing, but can be changed by the user. Fig. 13 shows a dose setting state of the drug delivery device, in which a number (not shown) shown in window 230 has changed compared to Fig. 12 so that it represents the dose size currently set. The device may be designed in such a way that during dose setting, the dose setting element 70 is displaced in the proximal direction relative to the housing 10. Alternatively, the dose setting element may remain in an unchanged axial position, regardless of the set dose. From the position shown in Fig. 13, a dispensing action can be initiated, expediently by moving or applying a force in the distal direction to the dose setting element 70 or the dose dispensing element provided in the near end section of the drug delivery device 1. To dispense a dose, the plug is displaced in the distal direction relative to the cartridge, for example by means of a piston rod of the device (not explicitly shown). A cartridge deflection element (not explicitly shown) such as a spring washer or an elastic cushion, for example made of rubber, may be located inside the housing. The deflection element may deflect the cartridge in the distal direction into contact with a proximal surface of the cartridge holder, for example the inner surface of the distal end wall 315. The deflection element may abut against the cartridge, for example against the cartridge housing, directly, for example against its proximal end to transfer its load to the cartridge, or indirectly via a rigid separating component.

The present design is intended for use in holding 1.5ml and 3ml cartridges in their cartridge holders. However, it can be easily adapted to hold any cartridge, ampoule or container within the housing where the advantages of easy assembly, high holding strength and increased tamper resistance are required.

The scope of protection is not limited to the examples discussed earlier in this document. Any invention disclosed in this document is realized in each new feature and each combination of features, which, in particular, includes each combination of any features that are listed in the claims, even if this feature or combination of features is not explicitly indicated in the claims or in the examples.

The terms "drug" or "medicinal product" are used synonymously herein to mean a pharmaceutical composition comprising one or more active pharmaceutical ingredients or pharmaceutically acceptable salts or solvates thereof and, optionally, a pharmaceutically acceptable carrier. An active pharmaceutical ingredient ("API"), in its broadest sense, is a chemical entity that has a biological effect in humans or animals. In pharmacology, a drug or medicinal product is used in the treatment, care, prevention, or diagnosis of disease, or is used to otherwise improve physical or psychological well-being. A drug or medicinal product may be used for a limited period of time or on a regular basis for chronic disorders.

As described below, the drug or medicament may include at least one API, or combinations thereof, in various types of formulations for the treatment of one or more diseases. Examples of APIs may include small molecules with a molecular weight of 500 Da or less; polypeptides, peptides, and proteins (e.g., hormones, growth factors, antibodies, antibody fragments, and enzymes); carbohydrates and polysaccharides; and nucleic acids, double-stranded or single-stranded DNA (including naked and cDNA), RNA, antisense nucleic acids such as antisense DNA and RNA, small interfering RNA (siRNA), ribozymes, genes, and oligonucleotides. Nucleic acids may be included in molecular delivery systems such as vectors, plasmids, or liposomes. Mixtures of one or more drugs are also contemplated.

The drug or medicinal product may be contained in a primary packaging or "drug container" adapted for use with a drug delivery device. The drug container may be, for example, a cartridge, syringe, reservoir, or other rigid or flexible vessel configured to provide an appropriate storage chamber (e.g., short-term or long-term storage) of one or more drugs. For example, in some cases, the chamber may be designed to store the drug for at least one day (e.g., from 1 to at least 30 days). In some cases, the chamber may be designed to store the drug for from about 1 month to about 2 years. Storage may occur at room temperature (e.g., about 20°C) or at refrigerated temperatures (e.g., from about -4°C to about 4°C). In some cases, the container for the drug may be or may include a two-chamber cartridge configured to separately store, one in each chamber, two or more components of the pharmaceutical composition to be administered (e.g., an API and a diluent, or two different drugs). In such cases, the two chambers of the two-chamber cartridge may be configured to provide mixing of the two or more components before and/or during the dosed administration to the human or animal body. For example, the two chambers may be configured to communicate with each other via a fluid medium (e.g., via a pipeline between the two chambers) and allow mixing of the two components at the user's discretion before dispensing a dose. Alternatively or additionally, the two chambers may be configured to mix during dispensing of the components to the human or animal body.

The drugs or drug products contained in drug delivery devices as described herein may be used to treat and/or prevent many different types of medical disorders. Examples of disorders include, for example, diabetes mellitus or complications associated with diabetes mellitus such as diabetic retinopathy, thromboembolic disorders such as deep vein thromboembolism or pulmonary embolism. Additional examples of disorders include acute coronary syndrome (ACS), angina pectoris, myocardial infarction, cancer, macular degeneration, inflammation, hay fever, atherosclerosis, and/or rheumatoid arthritis. Examples of APIs and drugs are those described in reference books such as the Rote Liste 2014, such as, but not limited to, major groups 12 (antidiabetic drugs) or 86 (antineoplastic drugs), and the Merck Index 15th edition.

Examples of APIs for the treatment and/or prevention of type 1 or type 2 diabetes mellitus or complications associated with type 1 or type 2 diabetes mellitus include insulin, such as human insulin or an analog or derivative of human insulin, glucagon-like peptide (GLP-1), GLP-1 analogs or GLP-1 receptor agonists, or an analog or derivative thereof, a dipeptidyl peptidase-4 (DPP4) inhibitor or a pharmaceutically acceptable salt or solvate thereof, or any mixture thereof. As used herein, the terms "analog" and "derivative" refer to a polypeptide that has a molecular structure that can formally be derived from the structure of a naturally occurring peptide, such as human insulin, by deleting and/or substituting at least one amino acid residue contained in the naturally occurring peptide and/or by adding at least one amino acid residue. The added and/or replaced amino acid residue may be either encoded amino acid residues, or other naturally occurring residues, or amino acid residues produced solely by synthetic means. Insulin analogs are also referred to as "insulin receptor ligands". In particular, the term "derivative" refers to a polypeptide that is characterized by a molecular structure that can formally be derived from the structure of a naturally occurring peptide, such as that of human insulin, in which one or more organic substituents (e.g., a fatty acid) are linked to one or more amino acids. Optionally, one or more amino acids that are present in the naturally occurring peptide may be deleted and/or replaced by other amino acids, including non-encoded amino acids, or amino acids, including non-encoded amino acids, may be added to the naturally occurring peptide.

Examples of insulin analogues are Gly(A21), Arg(B31), Arg(B32) human insulin (insulin glargine); Lys(B3), Glu(B29) human insulin (insulin glulisine); Lys(B28), Pro(B29) human insulin (insulin lispro); Asp(B28) human insulin (insulin aspart); human insulin in which proline at position B28 is replaced by Asp, Lys, Leu, Val or Ala and in which Lys at position B29 may be replaced by Pro; Ala(B26) human insulin; des(B28-B30) human insulin; des(B27) human insulin and des(B30) human insulin.

Examples of insulin derivatives are, for example, B29-N-myristoyl-des (B30) human insulin, Lys (B29) (N-tetradecanoyl)-des (B30) human insulin (insulin detemir, Levemir®); 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-omega-carboxypentadecanoyl-gamma-L-glutamyl-des(B30) human insulin (insulin degludec, Tresiba®); 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.

Examples of GLP-1, GLP-1 analogues and GLP-1 receptor agonists include, for example, lixisenatide (Lyxumia®), exenatide (Exendin-4, Byetta®, Bydureon®), a 39-amino acid peptide produced by the salivary glands of the Gila monster), liraglutide (Victoza®), semaglutide, taspoglutide, albiglutide (Syncria®), dulaglutide (Trulicity®), rExendin-4, CJC-1134-PC, PB-1023, TTP-054, Langlenatide/HM-11260C, CM-3, GLP-1 Eligen, ORMD-0901, NN-9924, NN-9926, NN-9927, nodexen, Viador-GLP-1, CVX-096, ZYOG-1, ZYD-1, GSK-2374697, DA-3091, MAR-701, MAR709, ZP-2929, ZP-3022, TT-401, BHM-034. MOD-6030, CAM-2036, DA-15864, ARI-2651, ARI-2255, exenatide-XTEN and glucagon-Xten.

An example of an oligonucleotide is mipomersen sodium (Kynamro®), a cholesterol-lowering antisense therapeutic agent for the treatment of familial hypercholesterolemia.

Examples of DPP4 inhibitors include vildagliptin, sitagliptin, denagliptin, saxagliptin, berberine.

Examples of hormones include pituitary hormones or hypothalamic hormones or regulatory active peptides and their antagonists such as gonadotropin (follitropin, lutropin, choriongonadotropin, menotropin), somatropin (Somatropin), desmopressin, terlipressin, gonadorelin, triptorelin, leuprorelin, buserelin, nafarelin, and goserelin.

Examples of polysaccharides include glycosaminoglycan, hyaluronic acid, heparin, low molecular weight heparin or ultra low molecular weight heparin or a derivative thereof, or a sulfated polysaccharide, such as a polysulfated form of the above-mentioned polysaccharides, and/or a pharmaceutically acceptable salt thereof. An example of a pharmaceutically acceptable salt of a polysulfated low molecular weight heparin is enoxaparin sodium. An example of a hyaluronic acid derivative is Hylan G-F 20 (Synvisc®), sodium hyaluronate.

The term "antibody" as used herein refers to an immunoglobulin molecule or an antigen-binding portion thereof. Examples of antigen-binding portions of immunoglobulin molecules include F(ab) and F(ab')2 fragments that retain the ability to bind antigen. The antibody may be polyclonal, monoclonal, recombinant, chimeric, deimmunized or humanized, fully human, non-human (e.g., murine), or a single-chain antibody. In some embodiments, the antibody has effector function and can bind complement. In some embodiments, the antibody lacks or has a reduced ability to bind an Fc receptor. For example, the antibody may be an isotype or subtype, fragment, or mutant of an antibody that does not maintain binding to an Fc receptor, such as having a mutagenized or deleted Fc receptor binding region. The term "antibody" also includes an antigen-binding molecule based on tetravalent bispecific tandem immunoglobulins (TBTI) and/or a cross-orientated dual variable region antibody-like binding protein (CODV).

The terms "fragment" or "antibody fragment" refer to a polypeptide derived from an antibody polypeptide molecule (e.g., a light and/or heavy chain antibody polypeptide) that does not contain a full-length antibody polypeptide, but still contains at least a portion of a full-length antibody polypeptide that is capable of binding to an antigen. Antibody fragments may contain a cleaved portion of a full-length antibody polypeptide, although the term is not limited to such cleaved fragments. Antibody fragments that are useful in the present invention include, for example, Fab fragments, F(ab')2 fragments, scFv (single chain Fv) fragments, linear antibodies, monospecific or multispecific antibody fragments such as bispecific, trispecific, tetraspecific and multispecific antibodies (e.g., diabodies, tribodies, tetrabodies), monovalent or multivalent antibody fragments such as bivalent, trivalent, tetravalent and multivalent antibodies, minibodies, chelating recombinant antibodies, tribodies or bitbodies, intrabodies, nanobodies, small modular immunopharmaceuticals (SMIPs), immunoglobulin domain binding fusion proteins, camelid antibodies and VHH containing antibodies. Additional examples of antigen-binding antibody fragments are known in the art.

The terms "complementarity determining region" or "CDR" refer to short polypeptide sequences in the variable region of both heavy chain and light chain polypeptides that are primarily responsible for mediating recognition of specific antigens. The term "framework region" refers to amino acid sequences in the variable region of both heavy chain and light chain polypeptides that are not CDR sequences and are primarily responsible for maintaining the precise arrangement of the CDR sequences to allow antigen binding. Although framework regions themselves are not typically directly involved in antigen binding, as is known in the art, certain residues in the framework regions of certain antibodies may be directly involved in antigen binding or may influence the ability of one or more amino acids in the CDR to interact with an antigen.

Examples of antibodies include anti-PCSK-9 mAbs (eg, alirocumab), anti-IL-6 mAbs (eg, sarilumab), and anti-IL-4 mAbs (eg, dupilumab).

Pharmaceutically acceptable salts of any API described herein are also contemplated for use in a drug or drug product in a drug delivery device. Pharmaceutically acceptable salts include, for example, acid addition salts and base salts.

Those skilled in the art will appreciate that modifications (additions and/or deletions) of the various API components, compositions, devices, methods, systems and embodiments described herein can be made without departing from the full scope and spirit of the present invention, which embraces such modifications and any and all equivalents thereof.

Link positions

300 cartridge unit

301 cartridge

302 cartridge holder

303 cartridge holding section

304 inner wall

305 hole

306 end of issue

307 medicinal product/drug

308 membrane

309 membrane retainer

310 warhead

311 main part

312 narrow part

313 cartridge surface

314 shoulder surface

315 distal end wall

316 hole

317 distal region

318 area of the main part

319 needle connector

320 connecting area

321 steps

322 fastener

323 sprue mark

324 mounting surface

325 hole

326 surface

327 hole

328 area with the first internal diameter

329 area of the second inner diameter

331 Shoulder area

340 cartridge body

341 amplifying section

342 cartridge support element

1 drug delivery device

120 cap

70 dose setting element

10th building

230 window

A thickness

B distance

PLP proximal loading path

DLP distal loading path

CLP circumferential load path

Y axis perpendicular to the distal or proximal direction

345 flexible lever

347 U-shaped cavity

350 area with reduced mechanical rigidity

355 area with increased mechanical rigidity

Claims (32)

1. A cartridge assembly (300) for a drug delivery device comprising: - a cartridge (301) containing a medicinal product (307), - a cartridge holder (302), the cartridge holder forms an internal section (303) holding the cartridge, wherein the cartridge is located inside the section holding the cartridge, wherein - the cartridge holder (302) comprises a distal region (317) with a needle connector (319) located at the distal end of the distal region (317), and a region (318) of the main part, - a fastening element (322) located in the distal region (317), - a region with reduced mechanical rigidity (350) compared to the rigidity of region (318) of the main part, wherein the region with reduced mechanical rigidity (350) is built into the distal region (317) and is located between the connector (319) of the needle and the fastening element (322), so that when the cartridge (301) is moved in the proximal direction, the resulting load is transferred from the cartridge (301) to the fastening element (322) and further to region (318) of the main part in the proximal direction, wherein the fastening element (322) comprises a permanent mechanical connection with the distal region (317) of the cartridge holder (302) in the circumferential direction. 2. The cartridge unit according to item 1, characterized in that the area with reduced mechanical rigidity (350) contains a groove or cutout. 3. The cartridge unit according to item 2, characterized in that the groove or cutout has a rectangular or rounded rectangular shape. 4. A cartridge assembly according to any of the preceding claims, characterized in that the fastening element (322) comprises a fastening surface (324), in particular a radially oriented surface, which is positioned so as to abut against a surface (313) of the cartridge, in particular a radially oriented surface, to prevent the cartridge from being removed from the cartridge holder, so that the cartridge is permanently fixed in the cartridge holder, wherein the surface of the cartridge is the proximal surface facing away from the end of the cartridge dispensing, wherein the surface of the cartridge is located between the dispensing end of the cartridge and the end opposite the dispensing end, and The fastening element is built into the cartridge holder. 5. The cartridge unit according to item 4, characterized in that the fastening element (322) protrudes from the inner wall of the cartridge holder (301) in the radial direction and, at the same time, the cartridge holder is designed in such a way that the fastening element can be elastically displaced in the radial direction. 6. A cartridge assembly according to claim 4 or 5, characterized in that the mounting surface (324) comprises a protrusion facing the surface of the cartridge. 7. The cartridge assembly according to paragraphs 4-6, characterized in that the fastening surface (324) is oriented relative to the surface of the cartridge (313) so that the surfaces face each other and are not parallel. 8. A cartridge assembly according to any of the preceding paragraphs, characterized in that the fastening element (322) comprises a region of reduced thickness. 9. A cartridge assembly according to any of the preceding paragraphs, characterized in that the section (303) holding the cartridge comprises at least three internal regions, i.e. a first region, a region of the fastening element and a second region, wherein the fastening element (322) is located in the region of the fastening element, and the region of the fastening element is located between the first region and the second region when viewed in the axial direction, wherein the internal diameter or clearance of the cartridge holder in the region of the fastening element is smaller than the internal diameter or clearance in the first region and in the second region, wherein the first region and the second region have different internal diameters or clearances. 10. The cartridge unit according to item 9, characterized in that one of the first region or the second region comprises a distal inner region located in the distal direction relative to the fastening element, wherein the distal inner region comprises two regions with two different inner diameters, wherein the region with the smaller diameter of the two different diameters is located in the distal direction relative to the region with the larger inner diameter. 11. A cartridge assembly according to any of the preceding paragraphs, characterized in that the cartridge (301) comprises a head part (310) with an end (306) for dispensing and a main part (311), wherein a narrow part (312) with a reduced diameter is provided between the head part and the main part, wherein the surface (313) of the cartridge is a surface that limits the head part in the axial direction. 12. A cartridge assembly according to any of the preceding paragraphs, characterized in that the cartridge holder (302) is closed in the radial direction along the entire angular or azimuthal extent of the fastening element and along the entire extent in the axial direction of the fastening element (322). 13. The cartridge unit according to claim 1, characterized in that the cartridge holder (302) comprises, alternatively or in addition to the region with reduced mechanical rigidity (350), a region with increased mechanical rigidity (350), which is located near the fastening surface (324) in the proximal direction and which reduces the radial flexibility of the cartridge holder (302) in such a region so that movement of the cartridge (301) in the proximal direction is difficult. 14. A cartridge assembly according to any of the preceding paragraphs, characterized in that the fastening element (322) is formed as a single unit with a section of the cartridge holder (302), wherein the section defines or forms an outer surface or an outer contour of the cartridge holder in at least one region of the cartridge holder. 15. A cartridge assembly according to any of the preceding paragraphs, characterized in that the region with reduced mechanical rigidity (350) is limited to a region distal relative to the fastening element (322). 16. A device (1) for delivering a medicinal product, comprising a housing (10) and a cartridge assembly (300) according to any of the preceding claims, which is removably attached to the housing, wherein the medicinal product (307) contained in the cartridge is a medicinal preparation.

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