RU2776138C1 - System for drug delivery device - Google Patents

Abstract

FIELD: medical technology.

SUBSTANCE: invention relates to medical technology, namely systems for drug delivery devices. The system contains a housing, a cartridge unit, which is designed to be attached to the housing or is removably attached to the housing. In this case, the cartridge unit contains a guide element of the cartridge unit, and the guide element of the cartridge unit is provided for establishing a guide interface with the housing in order to direct the relative movement of the cartridge unit and the housing relative to each other when attaching the cartridge unit to the housing. In this case, the cartridge unit contains an interfacing element of the cartridge unit, and the interfacing element of the cartridge unit is provided to form an additional interface in addition to the guide interface with the housing. In this case, an additional interface is installed when attaching the cartridge unit to the housing, and the guide interface is a bayonet-type interface that defines at least two different stages of movement between the cartridge unit and the housing when attaching the cartridge unit to the housing, the first stage with at least axial movement by the axial distance of the first stage in the axial direction of the first stage and the second stage at least with a rotary movement at the angle of the second stage in the direction of rotation of the second stage. In this case, the additional interface is or includes an interface with an inclined surface.

EFFECT: expansion of the range of drug delivery solutions.

13 cl, 15 dwg

Description

The present invention relates to a system for a drug delivery device, preferably an injection device and/or a pen-type device, such as a pen-type injection device.

In conventional drug delivery devices where a single drive mechanism, which may be housed in the body of the drug delivery device, is used in conjunction with multiple cartridges or ampoules to dispense the drug contained in the cartridge or ampule from the device, typically the cartridge holder of the device is releasably connected. with or attached to the housing and can be removed from or detached 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, the cartridge holder is reattached to the housing and the device is ready for reuse for dispensing medicine from a new cartridge.

However, devices of this type have several disadvantages. For example, a cartridge containing a drug for which the specific mechanism of the drug delivery device is not designed, i.e. the wrong drug, may be inserted into the cartridge holder without the user realizing that he has inserted the wrong drug cartridge into the cartridge holder. This error can be fatal to the user and is also very likely due to the fact that different drug cartridges look almost the same. In addition, if the cartridge is sold as a separate item, it is usually easily damaged, in particular because standard cartridges are usually glass cartridges.

The purpose of the present invention is to provide improvements related to drug delivery devices. This objective and potentially other objectives are achieved by the present invention and in particular by the subject matter of the independent claim. Preferred embodiments and improvements are the subject of the dependent claims.

One aspect of the present invention relates to a system for a drug delivery device. Another aspect relates to a drug delivery device that contains the system. The drug delivery device preferably contains a drug. Another aspect relates to the arrangement that contains the system or device.

In one embodiment, the system includes a housing. The housing may include one or more components of the dose setting mechanism and/or drive mechanism, such as a piston rod and/or a dose setting element, which, for example, is movable relative to the housing to set the dose and/or deliver the set dose. The piston rod can move distally relative to the body during dose delivery, suitably a distance that corresponds to the dose volume that has been previously set by the dose setting element.

In addition, the system contains a cartridge unit. The cartridge assembly may be attached to the body, or preferably releasably attached to the body. If it is releasably attached, the cartridge assembly can be attached to the body and, once attached, detached. The cartridge assembly may contain or hold a drug or drug to be delivered from a drug delivery device. By attaching the cartridge assembly to the housing, the system may form a drug delivery device. The cartridge block further comprises a cartridge block guide. The cartridge assembly guide is expediently provided to establish a guiding mate with the housing, for example, by interacting with a housing guide provided in or on the housing to direct relative movement of the cartridge assembly and the housing relative to each other, for example, when attaching the cartridge assembly to case or when detaching the cartridge unit from the case. The cartridge block may include one or a plurality of cartridge block rails. The body may contain one or more guide elements of the body. The corresponding guide element of the housing may be configured to cooperate with one guide element of the cartridge block. The cartridge block also contains a cartridge block interface. The cartridge block interface may be provided to form an additional interface, for example in addition to the guide interface, with the housing. The element(s) of the interface of the cartridge block may differ from the guide element(s) of the cartridge block. The guide element(s) of the cartridge block and the element(s) of the interface of the cartridge block can be displaced in the axial and/or angular direction relative to each other. The cartridge block may comprise one or more cartridge block interfaces. The housing may contain one or more housing interface elements. The housing interface element(s) can interact with the cartridge block interface element(s) to form an additional interface. Additional pairing can be established while attaching the cartridge assembly to the housing. Additional pairing is immediately established when the cartridge assembly is attached to the body. An additional mate can be set in the direction of the relative movement by means of a directional mate. Thus, when the cartridge assembly is attached to the body, the guide mate may already be established and may guide relative movement before an additional mate is established.

In one embodiment, the guide interface defines at least two different steps, a first step and a second step, of movement between the cartridge assembly and the housing when the cartridge assembly is attached to the housing. When attaching the cartridge assembly to the body, the first step may precede the second step. When the cartridge is detached, the second step may precede the first step. The first stage may be a stage with at least axial movement, for example only axial movement or axial and rotational movement, i.e. helical movement of the cartridge block relative to the body. The cartridge block may be moved during the first step by the axial distance of the first step in the axial direction of the first step. The axial direction of the first stage may be the direction towards the body. In the second step, the relative movement of the cartridge assembly relative to the housing includes at least a rotational movement by a second stage angle in the direction of rotation of the second stage. The second stage may include only rotary movement or rotary and axial, for example helical, movement. The helix along which the helical movement occurs in the second stage and the helix along which the helical movement occurs in the first stage may be in opposite directions. In the first step, the movement of the cartridge assembly relative to the housing may be predominantly axial. That is, the axial distance that is covered during this movement may be greater than the angular distance that the guide member of the cartridge block is rotated. In the second step, if this step includes rotational and axial movement, the movement may be predominantly rotational. Therefore, the angular distance traveled by the guide element of the cartridge block may be greater than the axial distance. The axial distance of the first stage may be greater than the axial distance of the second stage. The angular distance of the second stage may be greater than the angular distance of the first stage. The axis along which the cartridge assembly moves or about which it rotates may be the main longitudinal axis of the housing and/or cartridge assembly. The guide mate may be a bayonet mate or a bayonet type mate.

In one embodiment, the system is configured such that the cartridge assembly is moved relative to the housing in the second stage by a second stage axial distance in the axial direction of the second stage when the cartridge assembly is attached to the housing. The axial direction of the second stage may be opposite to the axial direction of the first stage. Thus, the cartridge block can be moved away from the housing during the second step, for example in a helix. The axial distance of the second stage may be less than the axial distance of the first stage. Axial movement in the second stage can have several advantages. First, movement in the opposite axial direction during the second step may occur just before the end of the procedure for attaching the cartridge assembly to the body. Accordingly, since this movement is noticeable to the user, the user can be sure that he has correctly attached the cartridge. In addition, axial movement in the opposite axial direction can help to provide such a specific starting position for drug delivery that even the first dose of drug that is dispensed from the device can be accurately dispensed and the prime filling operation can be avoided. In addition, movement in the opposite axial direction can be used to re-establish a working connection between two or more dose setting elements and/or the drive mechanism of the drug delivery device. Such a connection may be required for accurate delivery of the first dose already.

In one embodiment, the additional mate is an inclined surface mate or includes an inclined surface mate. Inclined surface mates have several advantages, which are detailed below.

In one embodiment, an additional pairing is established after the completion of the first stage, such as during or at the beginning of the second stage.

In one embodiment, the housing interface and/or the cartridge assembly interface comprises an inclined surface. In other words, the corresponding interface element may be an element with an inclined surface. The inclined surface may extend at an angle, preferably preferably at an angle. The sloped surface may face distally, for example if it is provided on the body. The sloped surface may face proximally, such as when provided on the cartridge block. The distally facing inclined surface may rise in the direction of rotation of the second stage. The proximally facing inclined surface may rise in a direction opposite to the direction of rotation of the second step.

In one embodiment, the movement of the axial distance of the second stage is determined or controlled by mating with an inclined surface. In other words, the connection to the sloped surface can be established in the second step. The slope of the ramp contacted by the interface, housing, or interface of the cartridge unit, in combination with the angle of rotation of the second stage, can be adjusted so that the cartridge assembly moves away from the housing by the axial distance of the second stage.

In one embodiment, the ramp is part of a ramp structure that includes a plurality of ramps that are preferably axially aligned and/or all rise in the same direction of rotation. The inclined surfaces can be arranged with rotational symmetry. The inclined surfaces may be circumferentially arranged around the main longitudinal axis of the housing or cartridge block, respectively.

In one embodiment, the slope or pitch of the ramp is less than or equal to the slope or pitch of the helical movement during the second stage, which may correspond to a helix angle that corresponds to the helical movement and/or a slope or pitch determined by the second stage axial distance and the second stage angle. stage. If the slope of the ramp is equal to the slope during the second step, the ramp can be used to provide axial movement in the axial direction of the second step. If the slope of the ramp is less than the slope during the second step, the ramp does not prevent movement in the axial direction of the second step. In the latter case, the movement in the axial direction of the second stage can be provided, for example, by a guide interface. However, for coding purposes, an inclined structure containing an inclined surface may still be used, as discussed in more detail below.

In one embodiment, the angular extent of the ramp is greater than or equal to the angular extension defined by the angle of the second stage, such as the angular extent defined by the angle of the second stage at the radial position of the ramp. Thus, the inclined surface can be adjusted to provide axial movement during the second step.

In one embodiment, the difference in height between opposite ends of the ramp, in particular between opposite corner ends that define the angle of the ramp, is greater than or equal to the axial distance of the second step.

In one embodiment, the sloped surface mate is not established until the first stage of movement is completed when attaching the cartridge assembly to the body.

In one embodiment, the corresponding ramp has a constant slope in the angular or rotational direction.

In one embodiment, the cartridge block comprises at least one cartridge block encoding construct. The cartridge block coding structure may be formed by one or more cartridge block coding elements.

In one embodiment, the package contains at least one package encoding design. The body coding structure may be formed by one or more body coding elements.

The coding design of the cartridge unit may be provided to mate the coding with the body coding design. The encoding pairing may be established before the second step of the move, for example during the first step, or even before the first step. By interfacing with the coding, the housing and/or actuator held in the housing can be matched to the drug, drug formulation, fill volume, and/or size of the cartridge or drug contained in the cartridge unit. If the cartridge block coding design and the body coding design do not match, the cartridge block is prevented from being attached to the body. To this end, the coding elements can interact mechanically and block further movement of the cartridge block relative to the housing. The coding ensures that only matching pairs of cartridge bodies and assemblies can be connected. Therefore, it is possible to avoid associating incorrect drugs or drug formulations or cartridges of incorrect sizes with a certain mechanism. The corresponding cartridge block coding element can be separated in the axial direction and/or at an angle from the cartridge block interface element, for example, in the distal or proximal direction. Thus, the encoding pairing and the additional pairing may be separate pairings. Alternatively, or additionally, the coded mate and the guide mate may be separate mates. Thus, standard guides and/or additional interfaces can be used, while distinction between different cartridge blocks, for example in terms of drug, drug composition and/or the size of the cartridge held in the cartridge block, can be achieved using specially designed coding elements. . For example, the coding features may be axially aligned, with the angular width and/or pitch and/or number of coding features varying to encode different cartridge assemblies with respect to different housings holding different actuators. The coding mate, in particular, differs from the slanted surface mate. If applicable, the guides may be used for coding purposes, for example by changing the angular width and/or distribution of the guides.

In one embodiment, an encoding element is provided in addition to the cartridge block guide and/or ramp(s).

In one embodiment, the corresponding housing coding element may be axially separated from the housing interface or from all of the housing interfaces. In particular, the encoding element can be separated in the axial direction from the elements involved in mating with the inclined surface.

In one embodiment, the coding element of the cartridge block is an axially extending element. The axially extending element can be limited in an angular direction, preferably in a direction opposite to the direction of rotation of the second stage, by a surface, i.e. an angular surface, which has a length or axial extent greater than or equal to the axial distance of the first stage. This ensures that the axial movement of the cartridge block relative to the body is allowed for the axial distance of the first stage, while the surface can move on the surface of the coding element of the body, which faces the surface of the coding element of the cartridge block. The surface of the body coding element may be an angled or angled surface that delimits the body coding element in an angular direction. This occurs if the coding designs of the body and the cartridge block match, and therefore the cartridge block can be attached to the body. During the second step, the angled surfaces may be separated by an angular distance determined by the angle of the second step. When the cartridge assembly is attached to the body, the angled surfaces of the body coding element and one of the cartridge coding elements may still face each other. If the housing coding and cartridge block designs do not match, the cartridge block coding element, eg its proximal facing surface, may abut against the housing coding element, eg its distal facing surface. This stop can block further axial movement of the cartridge block towards the body, in particular during the first step. The distally facing surface of the body coding element may be located in the vicinity of the angular surface of the body coding element. Thus, during or before the first stage of movement, inappropriate coding designs may prevent further axial movement due to the abutment of the coding element of the cartridge unit and the coding element of the body, in particular their axially facing surfaces.

In one embodiment, the corresponding housing coding element is an axially extending element. The corresponding body coding element can be limited in the angular direction, preferably in the direction of rotation in the second step, by an angular surface which can have an axial extent, in particular along the inclined surface, which is less than or equal to the axial distance of the first step. Thus, it can be ensured that the sloping surface can be reached by the interface element of the cartridge unit to mate with the sloping surface after the completion of the axial movement during the first step. .

In one embodiment, the sloped surface at an angle, for example in a direction opposite to the direction of rotation of the second stage, adjoins the corner surface, which extends along the sloped surface in the axial direction. Thus, it can be achieved that after the cartridge block has passed the axial distance of the first stage, the interface with the inclined surface is set so that during the second stage of movement the cartridge block is distally displaced by the axial distance of the second stage relative to the housing.

In one embodiment, the body coding element and the ramp and/or the cartridge block coding element are combined into a common ramp design. In particular, a surface area that defines the inclined surface of the inclined structure, for example, in the rotation direction of the second stage or in the opposite direction of rotation or the angular direction, may be provided as an encoding surface against which the encoding element of the non-corresponding cartridge block abuts during the first stage. If the cartridge block is a cartridge block matching the corresponding encoding design, the encoding element of the cartridge block passes through the sloped surface, and the cartridge block interaction element or the sloped surface of the cartridge block can interact with the sloped surface during the second step.

In one embodiment, the corresponding housing coding element and/or the corresponding cartridge block coding element is formed by an element that is part of the same sloped structure as the sloped surface, but is offset at an angle from the sloped surface, for example, in a direction opposite to the direction of rotation of the second stage, or in the turning direction of the second stage. The corresponding coding element may be a protrusion, preferably axially oriented.

In one embodiment, the cartridge assembly comprises a cartridge holder and/or cartridge. The cartridge may fit or be placed in the cartridge holder. The cartridge may contain a drug, or a drug formulation or drug. The proximal end of the cartridge may be closed with a movable plug or plunger. Provided that fluid communication between the inside of the cartridge and the outside is established, for example, with a needle piercing the membrane at the distal end of the cartridge, and the plug is displaced distally from the cartridge towards the cartridge outlet, the contents of the cartridge can be dispensed. from the cartridge. The cartridge block guide may be provided on an outer surface of the cartridge holder, such as on a side wall of the cartridge holder. A cartridge block guide may be provided in the proximal section of the cartridge holder. The middle section can be placed in the housing when the cartridge holder and the housing are connected.

In one embodiment, the cartridge assembly is a cartridge assembly. The assembly may include a cartridge and a cartridge holder. The cartridge may be permanently and/or permanently attached to the cartridge holder. Thus, the cartridge unit can be a disposable item. Alternatively, the cartridge may be releasably fixed in the cartridge holder. The cartridge holder may be that part of the cartridge assembly which is provided with a guide element, interface element and/or coding element. Thus, there is no need to change the standard cartridge design for encoding, guiding and/or interfacing purposes. The cartridge holder can provide additional protection for the cartridge. In addition, standard cartridges, such as 1.5 ml or 3.0 ml, can be used, for example, for various drugs or drug formulations. Cartridge assemblies may be assembled by the manufacturer and distributed. Different housings, actuators, matings and/or codings can be adjusted using different cartridge holders.

In one embodiment, the cartridge assembly interface element(s) and/or the cartridge block coding element(s) are axially offset from the guide element(s) of the cartridge block. The cartridge block interface element(s) and/or the cartridge block coding element(s) may be offset proximally or distally from the guide element(s) of the cartridge block. The cartridge assembly interface element(s) and/or the cartridge block coding element(s) may be incorporated into the proximal rim or end wall of the cartridge holder. In this case, there will be a displacement in the proximal direction.

In one embodiment, the cartridge holder includes a protrusion on its outer side. The projection may extend circumferentially around the cartridge holder, for example in the form of a flange. The cartridge unit interface element(s) and/or the cartridge block coding element(s) may be provided on the projecting part, for example, on its proximal surface. The guide member(s) of the cartridge assembly may be positioned in a proximal direction relative to the projection.

In one embodiment, the guide mate is a standard mate. Accordingly, the guide elements can be formed in the same way in different cartridge blocks. Differences may be present in the interface elements and/or encoding elements. Thus, the common coupling or guiding mechanisms can operate in the same way across all drug delivery devices in a set of devices, with the body of each device only connected to a cartridge assembly with the appropriate coding design or coding elements. Within a set or arrangement, the corresponding cartridge body and unit pair coding designs may be unique.

In one embodiment, the arrangement contains the system described above. The cartridge assembly of the system may be the first cartridge assembly, and the arrangement may comprise the second cartridge assembly. The second cartridge assembly may have the same configuration as the first cartridge assembly. In particular, it may have a guide element (elements) of the cartridge block and/or an element (elements) of the interface of the cartridge block, preferably of the same configuration and relative location. Preferably, the coding designs of the first and second cartridge units are different. This is particularly advantageous if the second cartridge assembly and the first cartridge assembly contain different drugs or drug formulations and/or contain cartridges of different sizes. Cartridges of different sizes may include cartridges of different lengths and/or diameters, such as inside or outside diameter.

In the context of this document, "different drugs" may mean that the unit cartridges contain drugs based on different active pharmaceutical ingredients. "Different drug formulations" may mean that the formulations may be based on the same active pharmaceutical ingredient, but the cartridge units contain a liquid, for example, with different concentrations of that active pharmaceutical ingredient.

The first cartridge block guide and the second cartridge block guide may be arranged and configured in the same way, and/or the cartridge block coding designs of the first and second cartridge block may be different. The coding structure of the cartridge block of the first cartridge block and the coding structure of the body are matched or compatible with each other. Thus, the first cartridge can be attached to the housing. The cartridge block coding structure of the second cartridge block and the body coding structure suitably do not match, so that the second cartridge block cannot be attached to the body. Thus, although the guide elements of the second cartridge assembly and the body can potentially be compatible with each other, inconsistent coding designs prevent the second cartridge assembly from being attached to the (first) body. The second cartridge block may have an encoding design that matches the second body, wherein the first cartridge block's encoding design prevents the first cartridge block from being attached to the second body. However, the first and second cartridge units, when connected to the first body or the second body, respectively, can perform the same sequence of movements, preferably with the same angular and/or axial distances. Thus, although the cartridge assemblies differ, the sequence of movements for attachment may already be familiar to the user, as well as the layout of the guide elements and/or their dimensions.

Preferably, the second cartridge block can be attached to the second body, but the first cartridge block cannot, due to different cartridge block coding designs. Like the first body and the first cartridge assembly, the second cartridge assembly and the second body may have cartridge assembly mates and body mates that cooperate to form an additional mate in addition to the guide mate during attachment. Optional mate includes sloping surface mate. The first ramp that controls, defines, or participates in the ramp interface between the first body and the first cartridge block and the second ramp, which controls, defines, or participates in the ramp interface between the second housing and the second cartridge block, may have the same slope. . The angular extent of the corresponding inclined surface may be greater than or equal to the angular extent determined by the rotation by the rotation angle of the second stage.

In other words, the first cartridge assembly and the second cartridge assembly and/or the first housing and the second housing may comprise inclined surfaces with the same slope and/or angular extent that is at least equal to that determined by the angle of rotation of the second stage. Thus, by providing a sloped design with integrated sloped surface(s) and encoding element(s), an encoding geometry or encoding system is used that can be installed in drug delivery devices without the need to adjust many parts or molds for parts.

In one embodiment, the cartridge and/or body assembly guides may be used for coding purposes, for example, by varying the width and angular positions between the guides for the first cartridge and body assembly and the guides for the second cartridge and body assembly. However, the first and second housings and/or the first and second cartridge assemblies may be provided with sloped surfaces having the same slope. However, the corresponding oblique construction does not contain encoding elements.

In other words, the first ramp may be part of a first ramp that includes a plurality of ramps, and the second ramp may be part of a second ramp that includes a plurality of ramps, the first ramp and the second ramp having a similar or identical configuration.

In one embodiment, the first coding element - the coding element of the body or cartridge block of the first body or the first cartridge block - is axially offset from the first oblique structure, and the second coding element - the coding element of the body or cartridge block of the second body or second cartridge block - is offset in axially from the second inclined structure.

In one embodiment, the sloped structures of the two cartridge assemblies have the same configuration, but the angular pitch of the cartridge assembly coding feature and/or the angular width of the cartridge assembly coding features vary between the first and second cartridge assembly. In this way, the attachment of the second cartridge unit to the body can be prevented. In this case, one or more guide elements of the cartridge block or body may form the coding elements of the cartridge block or body.

In one embodiment, the cartridge block encoding element of both cartridge blocks may be limited in the angular direction by a surface whose length is greater than or equal to the axial distance of the first stage.

In one embodiment of a kit or arrangement with two drug delivery devices, in which the drug delivery devices contain different drugs or drug formulations in cartridge units and/or cartridges of different sizes, the cartridge unit of the first device cannot be attached to the housing of the second device and preferably vice versa. Thus, cross-connection of cartridge assemblies with different actuators that are held in housings having the same general appearance can be avoided by different cartridge block coding designs of the corresponding cartridge block that are incompatible with the body coding design of another drug delivery device. Both devices may have respective ramp interfaces that may be set up and/or active during the second stage of movement.

In one embodiment of a kit or arrangement with two different drug delivery devices, each device being one of those described above, the cartridge units of either device may be detached from the device body and connected to the body of the other drug delivery device. These two cartridge units preferably contain the same drug or drug formulation and/or cartridges with the same dimensions, such as length, diameter and/or volume. The two devices preferably also comprise identical, for example in shape and/or arrangement, cartridge block interfaces and/or housing interfaces and/or cartridge block coding elements and housing coding elements.

In a particularly preferred embodiment, a system for a drug delivery device is provided, comprising:

- frame,

a cartridge block that is attachable to or releasably attached to the body, the cartridge block comprising a cartridge block guide, the cartridge block guide being provided to establish a guiding mate with the body to direct relative movement of the cartridge block and the body with respect to each other to each other when attaching the cartridge block to the body, and at the same time, the cartridge block contains an interface element of the cartridge block, and the interface element of the cartridge block is provided to form an additional interface in addition to the guide interface with the body, while the additional interface is established when the cartridge block is attached to the body, wherein the guide mate is a bayonet-type mate that defines at least two different stages movement between the cartridge block and the body when the cartridge block is attached to the body, the first stage with at least axial movement by an axial distance of the first stage in the axial direction of the first stage, and the second stage with at least a rotational movement by an angle of the second stage in the direction of rotation of the second stage, and wherein the additional mate is or includes an inclined surface mate.

As explained above, axial movement of the cartridge block away from the housing can be achieved by engaging with the inclined surface, preferably during the second step. This movement can be useful to achieve a certain initial position between the actuator, in particular the distal end of the piston rod and the plug in the cartridge. Alternatively or additionally, the coding elements may be incorporated into an overall sloped surface structure that provides the sloped structure.

The terms "distal" and "proximal" in the context of this document may refer to opposite axial directions or ends. The term "distal" may refer to the direction towards the dispensing end or the end of the drug delivery device component that is or should be located closest to the cartridge dispensing end, cartridge holder, cartridge assembly or drug delivery device. The term "proximal" may refer to a direction away from the dispensing end, or from an end that is, or should be, further from the dispensing end of a cartridge, cartridge holder, cartridge assembly, or drug delivery device.

The terms "axial", "radial", "angular" or "azimuth" in the context of this document may be used to refer to the main longitudinal axis of a device, cartridge assembly, cartridge, housing, or cartridge holder, such as an axis that passes through the proximal and distal ends of the assembly cartridge, cartridge, cartridge holder, or drug delivery device.

The features disclosed above in conjunction with a system, arrangement, drug delivery device, or set of drug delivery devices should not be construed as pertaining solely to the recited aspect or embodiment. Instead, the features also apply to other embodiments or aspects. Of course, the features disclosed in the specific embodiments described above or below can also be used in combination with each other and/or with other features of other embodiments.

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

In FIG. 1A-1F depict an embodiment of the cartridge assembly based on the schematic perspective view of FIG. 1A and a schematic sectional view of the assembly of FIG. 1B and different types of cartridge holder without the cartridge placed therein, in FIG. 1C-1F.

In FIG. 2A and 2B depict one embodiment of the cartridge assembly as a cartridge block based on the oblique view of FIG. 2A and the schematic sectional view of FIG. 2b.

In FIG. 3-13 show embodiments of drug delivery devices or systems for these devices based on schematic representations.

In FIG. 14 and 15 show an embodiment of a drug delivery device in two different situations.

Identical elements, elements of the same type, and elements of the same effect may be designated by the same reference numerals throughout the figures.

Further, in combination with FIG. 1A-2B, embodiments of cartridge assemblies are disclosed as cartridge blocks. In each case, the fasteners are built into the unit's cartridge holder. Before the details of the respective embodiments are disclosed, characteristic features that can be applied to all embodiments are described. In FIG. 1A-1F, as well as in FIG. 2A and 2B depict one embodiment of the cartridge assembly. The figure labeled "A" in each case shows a schematic perspective view of the cartridge assembly, while the figure labeled "B" shows only the distal region, i.e., the part of the assembly located near its distal end.

The cartridge assembly 300 includes a cartridge 301 and a cartridge holder 302. The cartridge 301 is located within the cartridge fixing or holding section 303 of the cartridge holder. The cartridge holding section is suitably delimited by the inner wall 304 of the cartridge holder 302, preferably along the circumference. The cartridge holder 302 includes an opening 305. The opening 305 is suitably a proximal opening. The proximal opening may provide access to the inside of the cartridge holder from the proximal end of the holder. Through the opening 305, the cartridge 301 can be inserted into the cartridge holder. The dispensing end 306 of the cartridge may 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 may be the end closest to the dispensing end 306 of the cartridge 301. The distal end of the cartridge holder is preferably designed in this manner to hold the cartridge in the holder, for example by means of an abutment, so that the cartridge can only exit the cartridge holder through opening 305. %, such as more than 80% or more than 90% of the total length of the cartridge. The entire cartridge may be covered by the cartridge holder 302 as depicted in the embodiments.

The end of the cartridge opposite the dispensing end 306, ie, the proximal end, is not shown explicitly in the figures. This end may be closed by a movable plug or plug, which is similarly not shown explicitly. A plug or plug may seal the proximal opening of the cartridge. The medicament 307 or medicament is contained in the region of the cartridge located between the dispensing end and the stopper. The drug or drug can be dispensed through the dispensing end 306 of the cartridge if fluid communication is provided between the interior of the cartridge and the surroundings and the plug is moved towards the dispensing end. The amount of drug 307 or drug in the cartridge is preferably sufficient for a plurality of doses, and the size of the dose may be set by the user or may be fixed, such as through the design of the drive mechanism used to deliver the drug from the drug delivery device that contains the cartridge. .

The terms "drug" or "drug" are used synonymously herein and refer to a pharmaceutical formulation containing 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 structure that has a biological effect on 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. The drug or drug product can be used for a limited period or on a regular basis for chronic disorders.

As described below, the drug or drug 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 (eg, 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 RNAs (siRNAs), ribozymes, genes, and oligonucleotides. Nucleic acids can be incorporated into molecular delivery systems such as vectors, plasmids, or liposomes. Mixtures of one or more drugs are also contemplated.

The drug or drug product may be contained in a primary package 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 container configured to provide an appropriate storage compartment (eg, short or long term storage) for one or more drugs. For example, in some cases, the chamber may be designed to store the drug for at least one day (for example, from 1 to at least 30 days). In some cases, the chamber may be designed to store the drug for a period of from about 1 month to about 2 years. Storage can take place at room temperature (eg, about 20°C) or at refrigeration temperatures (eg, from about -4°C to about 4°C). In some cases, the drug container may be, or may include, a dual-chamber cartridge configured to separately store, one in each chamber, two or more components of the pharmaceutical formulation to be administered (e.g., API and diluent, or two different drugs) . In such cases, the two chambers of the dual chamber cartridge may be configured to allow mixing of the two or more components prior to and/or during dosed administration to the human or animal body. For example, the two chambers may be configured to be in fluid communication with each other (eg, via a conduit between the two chambers) and allow the two components to be mixed as desired by the user prior to dispensing a dose. Alternatively, or additionally, the two chambers may be configured to mix while dispensing the components into the human or animal body.

Drugs or drugs contained in drug delivery devices as described herein can 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 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 (anti-diabetic 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 include insulin, e.g., human insulin or a human insulin analog or derivative, 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 "analogue" and "derivative" refer to a polypeptide that has a molecular structure that can be formally derived from the structure of a naturally occurring peptide, such as human insulin, by deletion and/or substitution of at least one amino acid residue. contained in a naturally occurring peptide, and/or by adding at least one amino acid residue. The amino acid residue added and/or substituted may be either encoded amino acid residues or other naturally occurring residues or exclusively synthetically obtained amino acid residues. 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 (for example, a fatty acid) bind to one or more amino acids. Optionally, one or more amino acids that are present in the naturally occurring peptide may be removed and/or replaced with other amino acids, including non-coding amino acids, or amino acids, including non-coding ones, may be added to the naturally occurring peptide.

Examples of insulin analogs are Gly(A21), Arg(B31), Arg(B32) human insulin (insulin glargine); Lys(B3), Glu(B29) human insulin (insulin glulisin); Lys(B28), Pro(B29) human insulin (insulin lispro); Asp(B28) human insulin (insulin aspart); human insulin, in which the proline at position B28 is replaced by Asp, Lys, Leu, Val or Ala, and in which Lys at position B29 can 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-(u-carboxyheptadecanoyl)-des(B30) human insulin; and B29-N-(u-carboxyheptadecanoyl) human insulin.

Examples of GLP-1, GLP-1 analogs, and GLP-1 receptor agonists are, for example, lixisenatide (Lyxumia®), exenatide (Exendin-4, Byetta®, Bydureon®), a 39 amino acid peptide that is produced by the salivary glands of the Arizona gilatooth) , 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, for example, mipomersen sodium (Kynamro®), a cholesterol lowering antisense therapeutic agent for the treatment of familial hypercholesterolemia.

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

Examples of hormones include pituitary 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, for example, the polysulfated form of the aforementioned polysaccharides, and/or a pharmaceutically acceptable salt thereof. An example of a pharmaceutically acceptable salt of 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" in the context of this document refers to an immunoglobulin molecule or its antigen-binding portion. Examples of antigen-binding portions of immunoglobulin molecules include F(ab) and F(ab')2 fragments, which retain the ability to bind antigen. The antibody can be a polyclonal, monoclonal, recombinant, chimeric, deimmunized or humanized, fully human, non-human (eg, murine) or single chain antibody. In some embodiments, the antibody has an effector function and can bind complement. In some embodiments, the antibody has no or reduced ability to bind the Fc receptor. For example, an antibody may be an isotype or subtype, fragment, or mutant of an antibody that does not support binding to an Fc receptor, eg, has a mutated or deleted Fc receptor binding region. The term "antibody" also includes an antigen-binding molecule based on tetravalent bispecific tandem immunoglobulins (TBTI) and/or an antibody-like binding protein with a dual variable region, characterized by cross-binding region orientation (CODV).

The terms "fragment" or "antibody fragment" refer to a polypeptide derived from an antibody polypeptide molecule (e.g., an antibody light and/or heavy chain polypeptide) that does not contain a full-length antibody polypeptide, but still contains at least a portion of a full-length antibody polypeptide, 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 polyvalent antibody fragments such as bivalent, trivalent, tetravalent and polyvalent antibodies, minibodies, chelating recombinant antibodies, tribodies or bitbodies, intrabodies, nanobodies, small modular immunopharmaceuticals (SMIPs) , immunoglobulin domain binding fusion proteins, camelid antibodies, and antibodies containing VHH. 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 polypeptides and light chain polypeptides that are predominantly responsible for mediating the recognition of specific antigens. The term "framework region" refers to amino acid sequences in the variable region of both heavy chain polypeptides and light chain polypeptides that are not CDR sequences and are primarily responsible for maintaining the precise arrangement of CDR sequences to allow antigen binding. Although the framework regions themselves are not usually 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 affect the ability of one or more amino acids in the CDR to interact with the antigen.

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

Pharmaceutically acceptable salts of any of the APIs described herein are also contemplated for use in a drug or drug delivery device. Pharmaceutically acceptable salts are, for example, acid addition salts and basic salts.

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

On the dispensing end 306 side, the interior of the cartridge that holds the medicament or medicament 307 is sealed by the membrane 308. The membrane 308 may be held in the cartridge body 340 or may be fixed relative to it by the membrane retainer 309. Membrane 308 may suitably be pierced, for example with a needle, which may provide fluid communication between the inside of the cartridge and the outside environment. The membrane retainer 309 may be formed by a cap, for example a metal cap such as an aluminum cap. The metal cap may be attached to the cartridge body 340 by a clip or crimp. The cartridge body may be made of glass. Housing 340 may define the outer contour of the cartridge. In the region of the dispensing end 306 where the needle is to pierce the membrane, an opening is provided in the membrane retainer 308 to allow the needle to pass through the membrane retainer region. The cartridge 301 includes a head portion 310 and a main body 311. The head portion 310 is located on the dispensing end 306 side. Body 311 may be located closer to the proximal end of the cartridge than head 310. Between head 310 and body 311, a narrow body 312 may be located. Body 311 may be an area where a plug or plug can move. The main part has a tubular configuration. Narrow portion 312 may have a reduced diameter, in terms of outer and/or inner diameter, compared to body 311. Head portion 310 has a reduced diameter, in terms of outer and/or inner diameter, compared to body 311. Narrow portion 312 has a reduced diameter compared to the main body, and also compared to the head part 310. The diameter may be the extension of the cartridge in a 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 may extend along the circumference. The entire cartridge 301 may be rotationally symmetrical about a major longitudinal axis. The transition between the head portion 310 and the narrow portion 312 may be formed by a relatively 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 may 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 may define the head portion 310 in the proximal direction, may have a slope relative to the radial direction, which is less than the slope of the shoulder surface 314, which limits the main body in the proximal direction. distal direction. The surface of the cartridge may 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 with a clamping action. Thus, the membrane retainer may extend from the distal end along the cartridge to the surface of the narrow portion of the cartridge body facing away from the distal end of the cartridge and extending in the radial direction to attach the membrane 308 to the cartridge body with a clamping action. The cartridge may comprise or consist of a cartridge body 340, a membrane 308, a membrane retainer 309, a medicament or medicament 307, and/or a stopper (not shown explicitly).

The cartridge holder 302 includes 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 may extend along a circumference, like a ring. The proximal surface of the distal end wall 315 is positioned to abut against the distal end surface of the cartridge 301. Thus, the cartridge 301 can be held in the cartridge holder without moving distally with respect to the cartridge holder 302. The distal end wall 315 may define an opening 316 in the cartridge holder. The end wall may extend around the opening, whereby 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 configured such that a needle may be guided through the opening towards the cartridge, particularly the membrane 308.

The cartridge holder 302 may include a distal region 317 and a body region 318. The distal region 317 is located closest to the dispensing end of the cartridge and/or to the distal end wall 315 of the cartridge holder. The body region 318 is located farther from the distal end or distal end wall 315 and/or closer to the opening 305 than the distal region. Compared to the main body region, the distal region may have a reduced outer diameter. This reduction can be determined by the reduced diameter of the head compared to the diameter of the main body of the cartridge. The body region 318 and the distal region may be connected by an inwardly directed shoulder region 331 . In the distal region, a needle connector 319, such as a thread, may be located. A needle assembly, such as a needle assembly cannula, may be attached to the cartridge holder 302 with a needle connector. A needle held in the cannula may be directed through opening 316, pierce membrane 308, and provide fluid communication with the interior of the cartridge to dispense medication or medication 307 from cartridge 301. Distal region 317 may be configured to accommodate a head part 310 of the cartridge 301. The area 318 of the main part can be configured to accommodate the main part 311 of the cartridge. On the side of the proximal end, the cartridge holder may have a connecting or mating region 320. In this region, connecting or mating elements can be provided that are configured to interact with corresponding elements on the body 10 in order to attach the cartridge assembly 300 to the body to form a device 1 drug delivery (see FIGS. 4 and 5). The connectors can be designed for threaded or bayonet connection between the cartridge holder and the housing. Preferably, the connecting or mating members are coded to match the housing housing the drive mechanism designed for the medicament contained in the cartridge of the cartridge assembly. The coding ensures that only the correct cartridge assembly can be attached 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 with a drive mechanism that is specifically designed to dispense the contents of the cartridge. The drive mechanism may include a piston rod located so as to drive the plug or plug in the distal direction relative to the cartridge, if it is necessary to dispense drug or drug from the cartridge. An embodiment of a potential encoding that can be applied to the cartridge holder is discussed in more detail below.

A radially outwardly extending step 321 or flange may 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 may extend around the entire circumference of the cartridge holder 302. The proximal surface of the step 321 may be positioned to contact the distal surface of the housing when the cartridge assembly is connected to the housing. The connection region 320 may be covered by the housing when the assembly is attached to the housing. However, the main body region 318 and the distal region 317 may protrude from the housing.

In addition, the cartridge holder 301 includes at least one fastener 322. As seen along the axial direction, the fastener 322 is provided between two interior regions of the cartridge holder, where one is adapted to receive and hold the head portion 310 and the other is adapted to receive and hold the main body. parts 311 of the cartridge. The fastener 322 may extend in the region of the narrow portion of the cartridge 301. The fastener 322 protrudes radially from the inner wall of the cartridge holder 301. Preferably, the fastener 322 reduces the inside diameter of the cartridge holder so that in that area the inside diameter is smaller than the outside diameter of the cartridge head.

Therefore, if the cartridge head is to be axially directed past the fastener from the proximal opening, the fastener must be deflected outward in the radial direction, eg displaced only in the radial direction. If the fastener is deflected, the head may miss the fastener. Preferably, the fastener is deflected by a head cooperating with a proximal surface of the fastener, which may be inclined, i.e. neither perpendicular nor parallel, with respect to the major axis of the cartridge holder. After the head has passed the fastener, the fastener can again move inward in the radial direction, for example resiliently. The inner region of the cartridge holder designed to receive the head portion 310 may have a reduced diameter compared to the area in which the body 311 is received.

The fastener 322 is integrally formed, such as by injection molding, with the cartridge holder section defining the outer surface or at least the outer contour of the cartridge holder. In other words, if applicable, the outer surface of the cartridge holder may be provided with a coating, while the outer contour may still be formed by the section of the cartridge holder into which the fastener is embedded. In FIG. 1A-4A depict a gate track 323 indicating the position where the fluid plastic composition is injected into the mold forming the cartridge holder geometry. The sprue track 323 is located in the area of the distal end wall 315 of the cartridge holder, in particular on the distal surface of the distal end wall.

The fastener 322 includes a fastening surface 324. The fastening surface 324 may be the distal surface of the fastener. Preferably, the fastening surface is oriented in the radial direction, i.e. it extends in the radial direction and/or plane. Mounting surface 324 is positioned to abut, or abut, against a proximal surface of the cartridge, such as cartridge surface 313. Thus, the cartridge surface 313 and the attachment surface 324 are positioned to prevent proximal removal of the cartridge from the cartridge holder through the opening 305 through mechanical engagement with each other. Accordingly, removal of the cartridge from the holder through the opening 305 is prevented by the fastening element 322. The fastening element 322 may be in the form of a latch and/or a bracket. The angular extent of the fastener or fastener surface may be less than or equal to one of the following values: 20°, 15°, 10°.

In addition, the outer wall of the cartridge holder is provided in the axial position of the fastener. 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 tampering with the cartridge assembly.

The following describes in more detail some embodiments of cartridge holders with fasteners built into the cartridge holder. The embodiment shown in FIG. 1A and 1B includes a single fastener 322, in particular a single fastener. Of course, a plurality of fastening elements can also be provided. Such an embodiment is shown in FIG. 2A and 2B and is very similar to the embodiment depicted in FIG. 1A and 1B.

The fastener 322 protrudes in the radial direction from the inner wall 304 of the holder 302 of the cartridge. The fastener 322 is located within the distal region 317 of the cartridge holder 302, and in particular in the internal region of the cartridge holder where the needle connector 319 is provided externally. As seen in FIG. 1A and also in FIG. 1B, the distal end wall 315, having a generally annular configuration, includes a hole 325. The hole 325 is oriented in the radial direction and interrupts the annulus formed by the distal end wall 315. The hole 325 extends radially outward from the hole 316. The angular and radial position of the hole 325 may correspond to the angular and radial position of the fastener 322 or the fastener surface 324 where the opening is axially offset from the fastener, such as distally. In particular, as seen from the distal end along the axis, the fastening surface can be seen from the distal end. The mounting surface may be framed in the radial and angular directions by side walls defining the opening 325. In the figures, the head portion 310 of the cartridge 301 is located between the opening 325 and the mounting surface 324. The angular dimension and/or the radial dimension of the opening 325 may form an angular dimension and/or a radial the size of the mounting surface and/or the fastening element, and may also correspond to them or may exceed them. The provision of an opening in the distal end region facilitates the molding of a cartridge holder with an integral fastener using only minor modifications to the mold or molding tool compared to a cartridge holder without fasteners. In a cartridge holder without a fastener, two mold pins of different diameters can be used to form an injection molded cartridge holder, with one mold pin defining the interior of the distal region and one mold pin defining the interior of the cartridge holder body region 318. The short shaping pin may define the interior in the distal region and the long shaping pin may define the interior region in the body region. The fastener 322 may be embedded directly at the intersection or boundary of two different molding tool studs. Hole 325 may be formed during the molding process and facilitates molding of the cartridge holder with fasteners 322 incorporated therein. Hole 325 may be formed by a protrusion, such as metal, on a short molding pin.

In the area where the fastener is located, such as in the distal area 317, the cartridge holder may be able to deform in the radial direction. Thus, the inner diameter can be increased when the cartridge holder is subjected to a radially outward force. The ability of the cartridge holder to deform in the radial direction when subjected to a radially directed force can be increased in that angular section of the distal region 317 that overlaps the opening 325 at an angle. The fastener 322 is located in this region because it overlaps the opening at an angle. The fastening element is suitably inflexible and/or rigid, for example more rigid than the distal region 317 or the inner wall of the first region where the cartridge head is to be located. Thus, when an axial and/or radial force is applied to the fastener, such as when the head is guided along and in contact with the fastener, the cartridge holder expands due to the rigidity of the fastener 322. The fastener itself does not deform or bend. After the head portion 310 has passed the fastener 322, the fastener moves inward again, and the cartridge surface 313 and the fastening surface 324 are positioned as shown in FIG. 1b. The fastening element preferably does not deform during this process and in particular does not deflect or rotate in the axial direction.

As shown in FIG. 1B, the sloping surface 326, which rises radially along its extent in the distal direction, is disposed distally with respect to the attachment surface 324. Due to this surface, which is preferably located on the opposite side of the attachment surface, or at least angularly offset from the attachment surface, the head portion 310 of the cartridge 301 can be provided to move in the radial direction towards the area radially overlapping the mounting surface 324. Thus, the sloping surface acts as a cartridge guiding member during assembly of the cartridge assembly 300. Therefore, references to the sloped surface 326 may be considered to be references to the element that guides the cartridge, and vice versa. Thus, it is possible to increase the radial overlap of the mounting surface 324 and the surface 313 of the cartridge 301 when the cartridge has reached its final position. The sloping surface 326 can improve the stability of the fixation of the cartridge in the cartridge holder, for example in the case where only one fastener is provided.

The distal offset (labeled "B" in FIG. 1B) of the cartridge guide element 326 away from the fastener, from the fastener surface 324, and/or the radial free end of the fastener 322 may be greater than the thickness (labeled "A" in FIG. .1B) cartridge membranes 308. This ensures that the membrane latch 309 rests on the more rigid cartridge body 340 and preferably not on the membrane when the cartridge engages the fastener 322 to radially outwardly move the element to temporarily expand the interior of the cartridge holder. Thus, the force required to move the element 322 is not transferred to the membrane. If the force were transmitted to the membrane, the risk of deformation of the membrane retainer 309, which may be a thin metal component, or the risk of damage to the membrane would greatly increase. This can be prevented by displacement in the distal direction between the element 326, guiding the cartridge, and the mounting surface 324 by a distance greater than the thickness 308 of the membrane. The displacement in the distal direction B is desirably less than the axial extension of the cartridge head 310 . Thus, the element guiding the cartridge can correctly guide the cartridge 301 radially inward by interacting with the head portion 310.

In the region of the interior of the cartridge holder 302 between the cartridge guide member 326 and the mounting surface 324, the internal diameter of the cartridge carrier interior may be larger than in the area of the cartridge guide member and/or in the area distal to the member, guide cartridge, if such an area is present, although it may or may not be present. In the area of the inner part of the cartridge holder between the element guiding the cartridge and the fastening surface, the inner diameter may be larger than the inner diameter in the area of the fastening element. In the region of the cartridge guide 326 and/or distal to the cartridge guide element, the inner diameter of the cartridge holder may be greater than the inner diameter in the region of the fastener, such as greater than or equal to the outer diameter of the head portion 310.

In other words, the membrane retainer or metal sleeve 309 includes 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 is moved past the mounting surface 324 before the distal the section will come into contact with the cartridge guiding element or with the sloping surface 326. Thus, the radial overlap of the metal sleeve 309 and the mounting surface is minimal during the assembly period when the mounting surface can damage the metal sleeve 309, and this overlap only increases after the mounting surface the surface moves past the distal section of the metal sleeve 309 and applies radial pressure to the proximal section. Because the proximal section rests on a harder material, such as glass, than the distal section, it will not be damaged or gouged. The final overlap between the mounting surface and the cartridge surface at the end of the assembly process is still high. The final overlap may be formed by the smaller internal diameter of the cartridge holder in the region of the sloping surface that marks the end of the sloping surface 326.

When testing the cartridge holder 302 with an integrated retainer 322, it was found that the distal section of the membrane retainer 309 is highly prone to pitting if the diameter before the sloping surface 326 is not significantly larger than the diameter after the sloping 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 only increases as the fastener presses on the area of the membrane retainer 309 where the head of the cartridge body, e.g. made of glass, supports/supports the membrane retainer, which may be thin and easily deformable metal component.

When the cartridge 301 is installed in the cartridge holder 302, the fastener 322 may block movement in the proximal direction of the cartridge 301 relative to the holder 302. However, the fastener does not expediently apply a locking force, such as a distal or 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 show further views of the cartridge holder 302. In FIG. 1C shows a view from the distal end. As is immediately apparent, the angular dimension of the fastener 322 is smaller than the angular dimension of the hole 325. The radial dimension of the fastener 322 or the fastening surface is also smaller than the radial dimension of the hole 325. FIG. 1D, also showing the distal end but in a perspective view, shows that the cartridge holder, in particular the distal region 317, is reinforced, i.e., has increased strength or wall thickness, in the region adjacent to the fastener 322 at an angle to him. The reinforcing section 341 extends circumferentially in the interior of the cartridge holder. The reinforcing section may axially overlap the fastening element. Alternatively or in addition, the reinforcing section 341 may be positioned distally with respect to the fastener 322. In a region of the interior of the cartridge holder that overlaps the fastener in the angular direction, the reinforcing section is preferably interrupted in order to promote radial deformability of the cartridge holder, when the head part displaces the fastener 322 in the radial direction.

As seen from the opening 325 axially to the mounting surface 324, the wall thickness of the holder 302 may be less than the wall thickness in the reinforcement section 341. The wall thickness of the cartridge holder 301 in the area of the fastener 322 and formed by the fastener may be greater than the wall thickness in the reinforcement section 341 The fastener 322 may extend radially over the reinforcing section 341. The reinforcing section 341 is also shown in FIG. 1F, which shows a perspective sectional view of the cartridge holder 302. In this figure, as well as in Fig. 1E, which is a view from the proximal end of the cartridge holder 302, shows that the interior of the cartridge holder includes a plurality of circumferentially, preferably evenly spaced, spacer or cartridge support elements 342, such as ribs. These elements 342 are oriented in the axial direction. These elements 342 may be provided to support the cartridge in the radial direction, such as to support its body 311 if the cartridge is held in a cartridge holder. These elements may be the only difference between a cartridge holder that accommodates smaller diameter cartridges and a cartridge holder that accommodates a larger diameter cartridge. The cartridge holder for a larger diameter cartridge may suitably not include cartridge support elements 342. Thus, the external dimensions of the cartridge holder may be unchanged, although the external diameters of the cartridges held in the cartridge holders are different.

As seen in the figures, for example in FIG. 1B, a needle connector 319, such as a thread, is distal to the fastener 322. In particular, the region between the fastener and the cartridge guide or sloped surface 326 may not include a needle connector 319. The needle connector may axially overlap the cartridge guide member 326 or may be offset distally from that member 326. Thus, the axial extension of the needle connector 319 may be less than other cartridge holder designs. For example, the needle connector 319 may be defined by a distal section of the distal cartridge holder region 317, where a connectorless region is located between the needle connector 319 and the body region. The axial extension of the region without the connector may exceed 50% of the axial extension 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 area between the fastener 322 and the guide 326 has a reduced wall thickness to increase the internal diameter of the cartridge holder 302, for example, to maintain a given external contour or size of the cartridge holder 302, providing an additional radial recess on the outside of this area, which may be required connector 319 will increase the risk of damage to the cartridge holder in this area or even make it impossible to mold it. Thus, a shortened needle connector is advantageous.

Although only one fastener is shown in the depicted embodiment, a sloping surface can also be provided if multiple fasteners are used. However, in the following embodiment, the sloping surface is not shown.

In FIG. 2A and 2B show a cartridge holder 302 with two integral fasteners 322. The fasteners 322 are opposed to each other, with each fastener having a fastening surface 324 positioned to abut a cartridge surface 313, which may be in the form of a flange. Two holes 325 are provided in the distal end wall 315 of the cartridge holder which interrupts the annular shape of the cartridge holder at positions corresponding in the angular and/or radial direction to the position of the mounting surface 324 of the respective fastener. A suitable hole 325 can be connected to the center hole 316. As previously described, this facilitates the integration of the fastener into the cartridge holder by injection molding, which is a particularly easy and cheap process suitable for high volumes. Therefore, the above description regarding the hole also applies to this embodiment. In addition, more than two fastening elements can also be provided. In FIG. 2B shows that the needle connector axially overlaps the fastener(s) 322.

Because the fastener 322 cooperates with the head in the depicted embodiments, cartridges with different body shapes can be easily fixed in the cartridge holder, such as cartridges with different volumes such as 1.5 ml and 3 ml, different diameters and/or lengths. The cartridge heads may have the same shape.

It should be understood that the present invention is particularly advantageous for cartridge assemblies with cartridges that are permanently affixed therein as cartridge units. However, cartridge holders with replaceable cartridges, in which the cartridge can be replaced in the cartridge holder, can also be used as cartridge units in the concepts described herein.

Cartridges of different sizes may have different lengths and/or different inner and/or outer diameters. The cartridge assembly may be a disposable item, such as those sold in pharmacies. Different cartridges of the same or different volume may contain different drugs or formulations of drugs. Smaller volume cartridges may have a higher drug concentration. If the drug is insulin or an insulin derivative, for example, the smaller volume cartridge may contain a concentration that is more than 2 times, for example 3 times, the concentration of the drug or drug in the larger volume cartridge. The drug or drug in the larger volume cartridge may be formed from the same active pharmaceutical ingredient. Differences in the content in different cartridges may be in the concentrations of the drug in the liquid, ie, in a particular formulation of the drug, and preferably only in this. For example, a 3 ml cartridge may contain 300 IU (IU: International Unit) of e.g. 3 ml cartridge.

In reusable drug delivery devices where the same drive mechanism may be used in combination with multiple cartridges, it is critical to ensure that only cartridges with a particular drug or drug formulation can be operatively attached to the drive mechanism, e.g. housing inside which the drive mechanism or its elements are held. This is sometimes achieved through so-called encoding or assignment systems or mechanisms. These systems or mechanisms may contain elements that are adjustable in such a way that in a set of two drug delivery devices, each of which contains a housing with a dose setting mechanism and / or a drive mechanism, as well as a cartridge unit detachably connected to the housing, where two cartridge units have different drugs, drug formulations and/or sizes, the corresponding cartridge unit can only be attached to the body of one device and not to the body of another device.

The following text describes embodiments of systems that are suitable for uniquely encoding cartridge units or assemblies with specific drugs, drug formulations, and/or cartridge sizes or volumes relative to housings or dose setting mechanisms and/or actuators held therein. This avoids using the wrong mechanism in conjunction with a particular cartridge assembly, such as one of the assemblies described above. The disclosed embodiments are particularly suitable for use in drug delivery devices that use a bayonet or bayonet-type connection between the cartridge assembly and the housing, which includes an initial at least axial movement (first step) and a subsequent at least an angular or rotational movement ( second step) when attaching the cartridge unit to the body. In addition, the disclosed concepts are intended to achieve axial movement of the cartridge block away from the body after the first step and before reaching the final position of the cartridge block with respect to the body.

One embodiment is described below in conjunction with FIG. 3. In FIG. 3 schematically depicts various situations (A-C) during connection of the cartridge assembly 300 to the housing or housing portion 350 of the drug delivery device. Situation A occurs shortly after the start of connection or attachment, that is, during the first stage of movement, situation B occurs after the completion of the first stage of movement and before the start of the second stage of movement, and situation C occurs when the final position of the cartridge block 300 relative to the housing is reached after the completion of the second stage movement. The lower part of the figure shows side views in situations A-C, and the upper part shows sectional views in the corresponding situation.

The cartridge assembly 300 is represented by a cartridge holder 302, such as one of the holders previously described. Of course, although not shown, the cartridge may be present in the cartridge holder. In FIG. 3 shows the connection area or mating area 320 of the cartridge holder. Within this region are one or more elements that are adjusted to interact with elements in the housing when the cartridge holder 302, cartridge assembly or assembly 300 is connected to the housing to form a drug delivery device. In particular, one guide element 327 or a plurality of guide elements 327 is placed in the area 320 of connection or mating. Different guide elements 327 can be aligned along the axis and separated from each other at an angle. The guide elements may have different angular or azimuth widths, as shown, or the same angular or azimuth width. Guide members 327 are provided to guide the movement of the cartridge holder 302 relative to the housing during assembly or attachment of the cartridge holder 302 to the housing. Cartridge holder 302 may, in particular in connection or mating region 320, comprise a locking or locking element 328. A plurality of locking elements 328, where only one of them is shown, may be provided, which are preferably arranged evenly in the angular direction, for example, diametrically opposed to each other. friend. The corresponding guide element 327 may be implemented as a protrusion protruding from the cartridge holder 302. The locking element 328 may have a helical shape or an extension. The locking member 328 may be designed to releasably lock the cartridge holder in its final position to prevent rotation relative to the housing in the direction required to disengage the cartridge holder 302 from the housing. This prevents accidental detachment of the cartridge holder from the housing.

The housing portion 350 may be integral with the (outer) housing 10 of the drug delivery device, as explained below, or as an additional component fixed in or on the housing. Part 350 of the body contains at least one, preferably a plurality of guide elements 351 of the body. The housing guide 351 may be a guide or a channel. The body guide 351 comprises two different sections, a first section 351a and a second section 351b. The first section 351a extends at least predominantly in the axial direction, for example only in the axial direction or along a helix. In the depicted embodiment, it runs along a helix. The angle of inclination of the helix along which the first section 351a extends may be the same as the angle defined by the helical extent of the locking member 328. The axial distance between two opposite ends of the section 351a may be greater than the angular extent of the first section. For example, the midpoints of the corresponding end can be taken as reference points for measuring the distances separating the ends.

The housing portion 350 has a distal end 352. Before assembling the cartridge holder 302 with the housing portion 350, the distal end 352 may face the cartridge assembly 300. The housing portion 350 may be hollow, such as a sleeve, to allow components of the drive mechanism and/or cartridge assembly to be housed within the opening of the sleeve member, or to be moved through the opening. Section 351a is expediently located closer to the distal end of the device or housing than the second section 351b of the guide element 351 of the housing. The second section 351b of the guide element 351 may extend at least predominantly at an angle, for example only at an angle or along a helix. In particular, the axial distance between opposite ends of the second section may be less than the angular extent of the second section. The axial distance the cartridge holder moves in the first section may be greater than the axial distance it moves in the second section. Alternatively or additionally, the angular distance that the cartridge holder moves in the first section may be less than the angular distance it moves in the second section. The axial distance that the cartridge holder moves in the second section or during the second step may be less than or equal to 1 mm, such as less than or equal to 0.5 mm. The guide mate may be a bayonet type mate. The directions of rotation in the first stage and in the second stage may be the same.

In the depicted embodiment, the first section 351a extends along a helix or is configured to define a helical interface. The second section 351b may only extend at an angle or helix and/or be configured to preferably have limited axial movement. Thus, there may be some axial play in the second section. This is preferably done if the second section only extends at an angle (see section 351b in Fig. 3C). The play may allow the cartridge holder 302 to move away from the body 350 during the second step, as will be explained below. If the second section runs in a helix (see leftmost section labeled 351b in FIG. 3A), there may be no end play. In particular, as shown in the figures, different body guides 351 may have second sections 351b with different configurations, for example, the second section of one body guide may extend in a helix, while the second section of another may only extend at an angle. The first sections of the various guide elements of the body can be made in the same way. The first section 351a of the guide element 351 of the housing may guide movement during the first step, for example, in axial and/or angular directions, while the second section 351b of the guide element may preferably direct only the angular or rotational movement of the cartridge holder relative to the housing. However, during the second stage of movement, there may still be an axial component to the movement of the cartridge assembly away from the housing. An additional pairing is established for this purpose, which will be explained in more detail below. Thus, since axial and angular or rotational movements are involved when the cartridge block guide 327 engages with the second section 351b of the body guide 351, the movement in that section can still be helical. The angle of inclination of the helix associated with movement during the second stage or in the second section may be less than the angle associated with the first section or the first stage. Alternatively or additionally, the helixes that define the helical extent of the respective sections 351a and 351b or the helical movement during the two stages may be oriented in opposite directions, for example they may be in opposite directions. Thus, while the guide 327 is in the second section, the cartridge holder can move in a distal direction relative to the housing, i.e., opposite to the axial direction in which it moves when movement is directed in the first section. Thus, when the guide element 327 interacts with or moves in the first and second sections of the guide element 351, different steps of movement occur. The mechanism, which has an initial movement in the proximal direction of the cartridge holder towards the body, followed by a movement in the distal direction from the body, is described in WO 2012/130704 A1, the entire content of which is incorporated herein by reference. However, the proposed concepts are applicable to other, preferably reusable, drug delivery devices, such as injection devices such as pen-type injection devices.

As mentioned above, the axial movement away from the housing during the second stage of movement may be caused by an additional mate, i.e. a mate different from the guide mate established by the cooperating guide elements 327 and 351. This mate may be an inclined surface mate. For this purpose, the cartridge holder, for example, at its proximal end, comprises at least one inclined surface 329 or a plurality of inclined surfaces. The housing contains at least one corresponding inclined surface 353 or a plurality of surfaces. The ramps 353 and 329 do not interact during the first stage of movement (situation A), they interact with each other at the end of the first stage (situation B), that is, after the cartridge holder has been moved the axial distance of the first stage towards the body , and interact with each other during the second stage (situation C). The slope of the ramps 353 and 329 may be the same.

However, it should be readily understood that one ramp is sufficient and the element sliding on the ramp may have a different, ie not necessarily ramp-like, geometry. The slope of the inclined surface is preferably constant. The slope of the ramp may be chosen such that during the rotational movement during the second step, the ramp causes an axial movement a distance d from the body (which occurs from situation B to situation C). As can be seen, in situation B, the axial gap between the guide element 327 and the wall delimiting the guide element section 351b in the distal direction may be equal to the distance d. At the end of the attachment process in situation C, the distal-facing surface of the guiding member 327 and the proximal-facing surface of the housing may be adjacent to each other. In situation C, the distance between the proximal-facing surface of the guide member 327 and the distal-facing surface of the body may be greater than or equal to d. In situation C, when the cartridge holder is attached to the housing, the locking member 328 engages with a mating locking member in the housing (not shown). The angle of rotation during the second step may be greater than 10° and/or less than 90°, such as less than 45°, such as approximately 20°.

The angular extent of the ramp 253 and/or 329 may be greater than the angle of rotation during the second step. This allows a section of sloped surface, such as sloped surface 253, to be used to abut an encoding element, such as a cartridge holder, if a cartridge holder with a mismatched encoding design is attempted to be attached to the housing. This will be explained below.

The cartridge holder 302 contains one or more encoding elements 330 . The coding element may be oriented in the axial direction. The coding element can be combined with the inclined surface into a common inclined structure. The coding element includes a surface 332 which delimits the coding element in an angular direction, for example in an angular direction opposite to the direction of rotation during the first step and/or during the second step. The rotation of the cartridge holder 302 relative to the housing portion 350 during the first step and the second step is clockwise when viewed from the distal end to the proximal end in FIG. 3. Surface 332 may extend axially and/or, when viewed axially, overlap sloped surface 329. Surface 332 may have an axial extent that is greater than d, greater than the axial distance during the first step and/or during the second step, and/or greater than the axial extent of the ramp 329 and/or 353. The angular extent of the ramp 332, if any, is expediently less than the angular span of the ramp 329 or 353. By selecting an axial extension greater than the axial distance traveled during during the first step and/or during the second step, the proximally facing surface 333 of the coding element 330, which abuts the surface 332 at an angle, such as in the direction of rotation during the first step and/or the second step, can be used to abut against an inclined surface 353 or other distal-facing surface in the body provided by the element body coding, in case of attempting to attach the cartridge holder to the wrong body. This stop prevents further axial movement of the cartridge holder towards the housing, and accordingly the second step cannot be performed and the cartridge holder cannot be attached to the housing. Thus, the coding is in effect during the first stage of the move, i.e. as early as possible, to alert the user if he or she tries to attach the wrong cartridge to the housing. When the length of the surface 332 is significantly greater than the axial distance during the second step or the "d" dimension, for example, at least twice the axial distance, it can be ensured that the coding element 330 can block the attachment of the cartridge holder at the beginning of the first step if the cartridge holder and body do not match. Alternatively, or additionally, it may be beneficial if the length of the surface 332 is greater than the axial distance during the first step.

The use of sloped structures in the housing or on the cartridge holder allows for a robust and easy to implement coding structure with a plurality of differently shaped and/or arranged encoding elements that form unique encoding designs together with sloped surfaces or sloped elements into an overall sloped structure. In other words, the coding elements and sloped surfaces can be axially aligned and separated at an angle. Such designs can be easily integrated into existing holders without significant modification of expensive forming tools.

The inclined structures used in the present invention can be made with rotational symmetry around a 180° rotation. Thus, the cartridge holder can be connected to the housing in two different rotational orientations. In a similar way, the guide elements can be arranged with rotational symmetry, in particular with respect to the 180° rotation.

The inclined surfaces of the inclined structures used in the present invention may be separated by coding elements located between them. The transition between the coding element and the subsequent inclined surface may be formed by a steep axially oriented surface or an inclined surface. The (angular) slope in the transition region between the two slopes may be greater than the slope of the slope.

In FIG. 4 shows an embodiment of a cartridge and body assembly with matching ramps or coding structures using a ramp or coding design that is different from the previous embodiment. Again, the cartridge assembly 300 and housing are shown in different situations A-C, but only in sectional views, since the guiding functional elements may be the same. In the following, only the differences from the previously described embodiment are discussed.

The key difference is that the cartridge holder 302 does not have an inclined surface, or at least no significant angular extension that interacts with the inclined surface of the housing during the second stage of movement. On the contrary, for engagement with the inclined surface 353 in the housing, the cartridge holder includes an element 334 for engaging with the inclined surface. The proximally facing surface 335 of this element 334 contacts the inclined surface 353, expediently before the second step, for example at the end of the first step (situation B). The element 334 may slide on the sloped surface 353 during the second step (situation C). At the end of the attachment procedure, the surface that delimits the element 334 in the angular direction, expediently in the direction of rotation during the second step, may abut at an angle against the element that delimits the inclined surface 353 in the angular direction. This may provide a reliable pivoting end stop in addition to or as an alternative to the end stop provided by the guide interface formed by the guide elements 327, 351. The angular extent of the sloped surface 353 may be greater than or, as shown, equal to the sum of the angular extent of the surface 335 and the angular extent, determined by the angle of rotation during the second stage along the inclined surface. It should be understood that the interaction element may also be located on the housing and on the inclined surface of the cartridge holder. The slopes of the inclined surfaces in the embodiments of FIG. 4 and FIG. 3 are equal so that they can provide axial movement of the second stage by a distance d. As is immediately apparent, the slanted structure in the housing is adjusted relative to the cartridge holder to provide a proper pairing of the cartridge assembly and housing. However, the cartridge holder 302 may include an inclined surface 329 that may abut against the housing member during the second step. The sloped surfaces 329 and 353 may have the same slope as shown. In appropriate cases, the sloped surface 329 may be sufficient and the sloped surface 353 may be omitted.

Thus, with the same guide mate but with different coding designs and/or slope designs, attachment of mismatched cartridge holders to the housing can be prevented, while the sloped surfaces of the slope structures can influence or provide axial movement during the second step.

In FIG. 5 shows that the cartridge holder of FIG. 4 cannot be attached to the body of FIG. 3. While still in the first stage of movement, the surface 333 of the encoding element 330 abuts against the inclined surface 353, for example, its end section, as seen in the rotational direction during the first stage. Therefore, further axial and/or rotational movement is prevented and the cartridge holder cannot be attached to the housing. Thus, due to different inclined structures, which comprise inclined surfaces with the same slope, as well as different designs and arrangements of the coding element (elements), the attachment of the cartridge holder to the housing is prevented, preferably already during the first stage of movement. This is true, although the same guide elements 327 and 351 for moving the bayonet type connection are present in the embodiments of FIG. 3 and FIG. four.

In FIG. 6 shows a row of seven different cartridge holders, each of which has an inclined plane or inclined design geometry. All of these are shown together with the housing or housing portion 350 in FIG. 3, that is, the inclined structure in the body is always the same. It can be seen that only one of the holders (the same embodiment shown in Fig. 3 and indicated by a hook (tick) under the image of the cartridge holder and housing) has a coding that is compatible with the housing, which means that it can only be attached to this housing . In another view, i.e. those marked with an "X", the cartridge holder coding elements come into contact with the body coding elements, such as ramp 353, before the completion of the first stage movement, such as screw. For each of the six incompatible cartridge holders, a compatible housing component can be created, which in turn is incompatible with all other cartridge holders. Thus, a set of multiple, eg up to seven or up to ten, coded cartridge holders can be provided; each is only compatible with a specific housing or drive mechanism. All systems shown have inclined surfaces with the same slope.

In FIG. 7 shows another embodiment of a cartridge assembly 300 (denoted A) and a body or body part (denoted B). The housing or housing portion 350 is shown in section, and the cartridge assembly is shown in plan view. In contrast to the previous embodiments, the slant structure that provides for the functionality of encoding and/or moving the axial distance of the second stage is not located at the proximal end or rim of the cartridge holder. On the contrary, it is provided on or in the proximally facing surface of the step 321. The step is located between the area 318 of the main part of the cartridge holder 302 and the area 320 of the interface where the guide elements 327 and the locking element 328 are located. Thus, unlike the previous embodiment implementation where it has been displaced in the proximal direction, in particular built into the proximal rim or edge of the cartridge holder, the slanted structure may be displaced in the distal direction from the guide elements 327 and/or the locking element 328. in the distal direction from the guide elements 351. Otherwise, the functionality is the same. Since the step can be provided in an already existing device, the sloped structure can be easily implemented on the proximal surface of the step 321.

In FIG. 8 shows the sequence of attaching the cartridge holder 302 and the housing or housing portion 350 shown in FIG. 7 in three different situations (labeled A-C) that correspond to those discussed above. Because the sloped structures match each other, the cartridge holder can be attached to the housing. The ramps or surfaces of the shoulder or step 321 function in the same manner as previously described. By changing the geometry of the inclined surfaces of the cartridge holder in the same or similar manner as described above with reference to FIG. 3-7, you can create a set of coded cartridge holders and housings.

In FIG. 9 shows three pairs of housings or housing portions 350 and cartridge holders 302, with the housing always having the same slant design, but the cartridge holder slant designs being different. The pair on the left have corresponding slanted designs (indicated by a hook or check mark), while the others do not (indicated by an "X"). As can be seen from the two pairs on the right, axial movement towards the hull is stopped due to inappropriate slope structures before the second stage of movement can occur, i.e. the guide is still in the first section 351a when further movement is blocked.

In FIG. 10 and 11 show another coding design that can be used in conjunction with a bayonet type connection between cartridge holder and housing. In FIG. 10 shows the cartridge holder 302 when connected to the housing or housing portion 350. The housing guide 351 also has two sections 351a and 351b, where, unlike the previously described embodiments, the first section extends only in the axial direction and the second section only at an angle. The guide does not have a section that runs along a helix. Thus, in the first step, only axial movement occurs, and in the second step, only angular movement occurs, as in the illustrated embodiment, where the guide element 327 has the same axial dimension as the second section 351b, or angular and axial movement, preferably helical movement, as will be described below. The latter allows for axial movement of the cartridge holder 302 in the distal direction during the second step. After completion of the second step, as previously described, rotation of the cartridge holder 302 relative to the housing or housing portion 350 is prevented.

The coding functionality of the cartridge block is implemented by guide elements 327 or projections that simultaneously act as coding elements. Coding can be implemented by changing the angular width - wide elements 327a and narrow elements 327b - and/or relative angular positions of preferably axially aligned guide elements 327 together with appropriately designed guide elements 351 in the housing for the respective housing. Guide elements of the same type - wide or narrow - can remain in the same angular position, while the position of narrow guide elements can change. In FIG. 11 shows possible protrusion locations for a number of five different cartridge holders 302, viewed in each case from the open end of the cartridge holder. It can be seen that each holder 302 has two sets of protrusions or guides, a first set of opposite "wide" protrusions and a second set of opposite "narrow" protrusions. It can also be seen that the wide lugs are located at the same angular position in each case, while the narrow lugs are rotated to a different angular position relative to the wide lugs in each case. This arrangement of the protrusions provides a set of codes, which means that each different cartridge holder variant can only engage with a housing that has channels or guides 351 located at the same angular position as the guides or protrusions of the corresponding cartridge block.

In contrast to the tilted designs with built-in coding elements, which are described further above, this coding design, which uses the angular width and/or position of the guide elements, does not allow the cartridge holder to axially move away from the housing during the second step. A potential solution to this problem could be the introduction of helical channels for the second area of movement, ie helical second sections 351b. However, they can be difficult to cast in the main component. An alternative solution, which is probably easier to manufacture, is shown in FIG. 12. Image A in FIG. 12 shows a side view when the cartridge holder 302 is assembled with the body, and image B shows a sectional view. As can be seen, the second section is axially wider than the axial extent of the guide member to allow distal displacement of the cartridge holder relative to the housing, for example by a distance d, during the second stage of movement. The housing or housing portion has one or more inclined surfaces 353. These surfaces can engage with the cartridge holder 302 and lift the cartridge holder 302 axially away from the housing during the second stage of movement. In the end position, there may be an angular gap 336 between the axially overlapping angular surfaces of the cartridge holder 302 and the housing or ramp facing each other. Angular clearance 336 may be greater than or equal to the angle of rotation during the second stage of movement. The cartridge holder 302 may have an inclined surface 329 as shown or an interaction element 334 as previously described.

The coding elements, in particular the housing elements, i.e. the guide elements 351, are offset in the axial direction from the inclined surfaces 353.

Another concept for creating a set of, for example, two incompatible cartridge holders is shown in FIG. 13. In this embodiment, one of the cartridge holders (shown on the left in FIG. 13, image A) has bayonet protrusions formed in the usual way on its outer cylindrical surface. Another holder (shown in the right image, image B) has bayonet channels formed on its outer cylindrical surface; wherein the protrusions are formed for this variant on the inner wall of the respective body.

It should be noted that this concept, i.e. changing the type of guide elements - channels or guides to ledges or vice versa - can be applied to any of the other embodiments, since the overall functionality of the interfaces formed by the guide elements on the body and on the cartridge holder, does not change when the protrusions are replaced by channels and vice versa. This can be used for encoding, but is not required. Thus, when a protrusion is described as guides 327 on cartridge holder 302, they may alternatively be on the body or body portion 350, and when channels or guides are shown as guides 351 on the body or body portion 350, alternatively they may be on the cartridge holder.

In FIG. 14 and 15 schematically depict embodiments of a drug delivery device suitable for use in conjunction with the disclosed cartridge assemblies or systems and mechanisms. In FIG. 14 shows the device 1 in a state where the cap 120 is attached and covers the cartridge assembly 300 or block. In FIG. 15 cap removed. The cartridge assembly 300 is connected, expediently in a releasable manner, to the body or body 10 of the drug delivery device 1 as shown in FIG. 6. The housing expediently forms the outer contour of the device and may be in the form of a sleeve. The housing portion 350 may be held within the housing 10. The needle assembly may be attached to the needle connector 319 to dispense medication or medicament from the device 1. The dose setting member 70 is movably held within the housing 10 and can be manipulated by the user to set the dose. For example, it can be rotated relative to the body 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 held in the housing, but can be changed by the user. In FIG. 15 shows the dose setting state of the drug delivery device, with the number displayed in window 230 changed compared to FIG. 14 so that it represents the dose size currently set. The device can be designed such that during dose setting, the dose setting element 70 is displaced proximally relative to the body 10. Alternatively, the dose setting element can remain in the same axial position, regardless of the set dose. From the position shown in Fig. 15, it is possible to initiate the dispensing action, expediently by moving or applying force in a distal direction to the dose setting element 70 or the dose dispensing element provided in the proximal end section of the drug delivery device 1. To dispense a dose, the stopper is displaced distally relative to the cartridge body 340, for example by means of a piston rod of a device (not shown explicitly).

With the coding systems described above, it can be ensured that only the type of cartridge block 300 containing a particular drug or drug, drug formulation, or drug formulation and/or volume for which the drive mechanism in housing 10 is intended can be attached to body 10.

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

Reference positions

300 cartridge assembly

301 cartridge

302 cartridge holder

303 cartridge holding section

304 inner wall

305 hole

306 end of issuance

307 medicine

308 membrane

309 membrane retainer

310 head

311 main body

312 narrow

313 cartridge surface

314 shoulder surface

315 distal end wall

316 hole

317 distal region

318 main body area

319 needle connector

320 connecting area

321 steps

322 fastener

323 trace from the sprue

324 mounting surface

325 hole

326 surface

327 guide element

328 locking element

329 inclined surface

330 encoding element

331 shoulder area

332 surface

333 surface

334 inclined surface interaction element

335 surface

336 corner clearance

340 cartridge body

341 amplifying section

342 element for cartridge support

350 body part

351 guide element

351a,b section

352 distal end

353 inclined surface

1 drug delivery device

120 cap

70 dose setting item

10 building

230 window

A thickness

B distance

Claims (31)

1. A system for attaching the cartridge unit to the body of the drug delivery device (1), comprising: - body (10, 350), - a cartridge unit (300) which is configured to be attached to the body or releasably attached to the body, wherein cartridge block contains a guide element (327) of the cartridge block, wherein the guide element of the cartridge block is provided to establish a guide interface (327, 351) with the body to direct the relative movement of the cartridge block and the body relative to each other when attaching the cartridge block to the body, and the cartridge block comprises a cartridge block interface (329, 334), wherein the cartridge block interface is provided to form an additional interface in addition to the guide interface with the body, the additional interface being established when the cartridge block is attached to the body, wherein the guide mate is a bayonet-type mate that defines at least two different stages of movement between the cartridge block and the body when the cartridge block is attached to the body, the first step (351a) with at least axial movement by the axial distance of the first step in the axial direction of the first step and a second stage (351b) with at least a pivotal movement by a second stage angle in the rotational direction of the second stage, wherein the additional mate is or includes a slanted surface mate, wherein the cartridge block comprises at least one cartridge block coding structure (330), wherein the cartridge block coding structure is provided to establish an encoding mate with at least one structure body coding element (353) body coding before the second stage of movement, and at the same time the cartridge block coding structure comprises one or more cartridge block coding elements (330), wherein the corresponding cartridge block coding element is an axially extending element that is limited in the angular direction by a surface (332) that has an axial extent greater than or equal to axial distance of the first stage. 2. The system according to claim 1, characterized in that it is made in such a way that the cartridge block (300) moves relative to the housing (10, 350) in the second stage by the axial distance (d) of the second stage in the axial direction of the second stage, opposite to the axial direction of the first stage, when attaching the cartridge block to body, and the movement of the axial distance of the second stage is determined or controlled by pairing with an inclined surface. 3. The system according to any of the previous paragraphs, characterized in that the body (10, 350) contains a body interface element (353), which is configured to interact with the cartridge block interface element (329) to establish an additional interface, wherein at least one of the body interface element and the block interface element cartridge contains an inclined surface (329, 353). 4. The system according to paragraphs. 2 and 3 characterized in that the slope of the inclined surface (329, 353) is equal to the slope determined by the axial distance (d) of the second stage and the angle of the second stage. 5. The system according to paragraphs. 2 and 3 or according to item 4, characterized in that the height difference between opposite ends of the inclined surface is greater than or equal to the axial distance (d) of the second stage. 6. The system according to any one of the preceding claims, characterized in that the cartridge block coding structure comprises one or more cartridge block coding elements (327a, 327b), wherein the corresponding cartridge block coding element is axially separated from the cartridge block interface element (329, 334). 7. The system according to any one of the preceding claims, characterized in that the corresponding housing coding element or the corresponding cartridge block coding element is formed by an element that is part of the same inclined structure as the inclined surface, but is offset at an angle relative to the inclined surface. 8. The system according to any of the previous paragraphs, characterized in that the cartridge assembly (300) is a cartridge assembly that includes a cartridge holder (302) and a cartridge (301), the cartridge containing a medicament (307) with the cartridge permanently fixed in the cartridge holder. 9. An arrangement comprising a system according to at least one of the preceding claims, wherein the cartridge assembly (300) of the system is the first cartridge assembly, and the arrangement comprises a second cartridge assembly (300), the second cartridge assembly having a guide member (327) of the second cartridge block and element (329, 334) interface of the second cartridge block, wherein the first cartridge block and the second cartridge block contain different drugs or drug formulations and/or contain cartridges of different sizes, wherein the cartridge block coding structures of the first and second cartridge blocks are so different that the cartridge block coding structure of the first cartridge block and the body coding structure correspond to each other, whereby the first cartridge block can be attached to the body (10, 350) and the second cartridge block coding structure the cartridge block and the body coding design do not match, so that the second cartridge block cannot be attached to the body. 10. Arrangement according to claim 9, characterized in that the housing (10, 350) is a first housing and the arrangement comprises a second housing, wherein the second cartridge unit can be attached to the second housing, but the first cartridge unit cannot due to different cartridge unit coding designs, and when In this case, the second cartridge block and the second body have elements (329, 334) of the interface of the cartridge block and elements (353) of the interface of the body, which interact to form an additional interface in addition to the guide interface, and the additional interface includes an interface with an inclined surface, while the first inclined the surface that controls the ramp engagement between the first body and the first cartridge unit and the second ramp that controls the ramp engagement between the second body and the second cartridge unit have the same slope. 11. Arrangement according to claim 10, characterized in that the first inclined surface is part of the first inclined structure, which contains a plurality of inclined surfaces, and the second inclined surface is part of the second inclined structure, which contains a plurality of inclined surfaces, and the first inclined structure and the second structure have the same configuration. 12. The drug delivery device containing the system according to any one of paragraphs. 1-8, wherein the drug delivery device contains a drug. 13 A set of drug delivery devices, containing the layout according to any one of paragraphs. 9-11, wherein the respective drug delivery device contains the drug.

Images