RU2779516C2 - Drug delivery device and method for modification of drug delivery device - Google Patents

Abstract

FIELD: medical equipment.

SUBSTANCE: invention relates to medical equipment, namely to drug delivery devices (1). The device contains: case (10, 350); drive mechanism (5); cartridge (301) containing drug (307), while the cartridge is retained in a set position relatively to the case, and the drive mechanism is made with the possibility of dosing of the drug from the cartridge; cartridge preload system (400) containing at least one elastic element (402, 403) and at least one force-transferring rigid part (401), in which the force-transferring rigid part is retained in the case with the possibility of movement, the cartridge preload system is located and made with the possibility of application of a force to the cartridge for maintenance of the cartridge in the set position, the specified force is created by at least one elastic element, and the force-transferring rigid part is functionally connected to at least one elastic element so that the force-transferring rigid part perceives this force. A method for modification of a drug delivery device is additionally described.

EFFECT: obtaining a drug delivery device.

3 cl, 16 dwg

Description

The invention relates to a drug delivery device, in particular to an injection device such as a pen-type drug delivery device and/or a pen-type syringe. In addition, the present invention relates to a design containing two drug delivery devices. In addition, the present invention relates to a method for modifying a drug delivery device.

Often, a drug delivery device includes a cartridge preload element, such as a spring, that compresses the cartridge to maintain the cartridge in position relative to other elements of the device. Because the cartridge can be fixed and not move during dose insertion and/or delivery, it can deliver accurate doses from the drug delivery device. The cartridge preload element can be provided with manufacturing tolerances, which results in small variations in the length of the cartridges within the manufacturing tolerances, despite the fact that the cartridges should nominally be of the same length.

It is an object of the present invention to provide benefits associated with a cartridge preload system or design used to preload cartridges in drug delivery devices. These objectives are achieved by the subject matter of the independent claims, but may be achieved by other subject matter described herein. Preferred embodiments and specifications are the subject of the dependent claims and may also appear throughout the remainder of this specification.

One aspect of the present invention relates to a drug delivery device. The drug delivery device includes a housing. The housing may, for example, be tubular in shape. The housing may be a sleeve. The drug delivery device further comprises a drive mechanism. The drive mechanism can be held in the housing with the possibility of movement. The drive mechanism may include, for example, a piston rod. The plunger rod may be movable in a distal direction relative to the housing for the purpose of dispensing a drug. The drug delivery device further comprises a cartridge containing a drug or drug, in particular in an amount sufficient for a plurality, preferably set by the user, of doses. The cartridge may include a plug that can be moved distally from the cartridge body to dispense from the cartridge the drug or drug, such as a liquid drug or drug, held in the cartridge. The cartridge is suitably held in position relative to the housing. The drive mechanism may be configured to dispense medication from the cartridge. For example, distal movement of the piston rod may be transmitted to the plug such that the plug moves relative to the body in a distal direction. The drug delivery device further comprises a cartridge preload system. The cartridge compression system comprises at least one elastic element, such as only one elastic element or a plurality of elastic elements, such as two elastic elements, and at least one force-transmitting rigid part, such as, for example, only one force-transmitting rigid part or a plurality of force-transmitting rigid parts. The force-transmitting rigid member is preferably rigid, at least with respect to deformations in the axial direction. Accordingly, the force-transmitting rigid member can be used to transmit axial forces to the drug delivery device. The force-transmitting rigid piece is movably held in the housing. The rotation of the force-transmitting part may be locked relative to the housing, but it may be movable in an axial direction relative to the housing. Alternatively, the force-transmitting member may be rotatable and movable in an axial direction relative to the body. The axial movement of the force transmitting part relative to the housing is preferably limited, for example, by a distal stop limiting the distal movement of the force transmitting part relative to the housing and/or a proximal stop limiting the proximal movement of the force transmitting part relative to the housing. When the part abuts against an appropriate abutment, further movement in the distal or proximal direction can be prevented.

The cartridge compression system of the drug delivery device is positioned and configured to apply force to the cartridge to maintain the cartridge in a predetermined position. This force is preferably provided by an elastic element. The force may be a force directed distally. The force-transmitting rigid member may be operatively connected to the resilient member and/or the cartridge such that the force-transmitting member receives the force and/or is transmitted to the cartridge via the force-transmitting member. In other words, the force-transmitting rigid member may be located in the load transmission path between the resilient member and the cartridge. For example, a force-transmitting rigid piece may be located between the resilient element and the cartridge. The resilient element may be located proximal to the force-transmitting part. The force-transmitting rigid member may be positioned proximal to the cartridge. The cartridge compression system may be retained in the housing.

Providing a force-transmitting rigid piece in addition to the elastic element has many advantages. For example, by providing a force-transmitting rigid piece, the resilient element can be adapted to its primary function, i. application during deformation of the elastic restoring force, which seeks to restore the undeformed shape of the elastic element. This force may be an axial force, preferably without an angled component. In particular, there is no need to take into account the dimensions of the cartridge in the design of the elastic element. In this way, the dimensions of the resilient element can be adapted to the free space available in the housing without having to take into account the size of the cartridge. The force-transmitting rigid member may provide a bridge or spacer that provides a functional connection between the resilient element and the cartridge. In addition, a force-transmitting rigid member can be used to adapt an existing drug delivery device for use with a cartridge of a different size, such as a reduced length and/or diameter, such as as further explained below. Thus, the force-transmitting rigid member may provide improvements in resilient design and/or device variability that can be more easily used with different cartridges by adding a force-transmitting rigid member to an existing device. In addition, since the force transmitting part is rigid, it is not necessary to adapt the elastic elements in the systems to another axially flexible element in the system. More precisely, it is possible to use standard resilient elements which only adapt to a cartridge of a new size or length by means of a force-transmitting rigid piece.

In an embodiment, the force transmitting rigid member comprises a first load transfer surface facing the cartridge and a second load transfer surface facing away from the cartridge. The first load transfer surface may be the distal surface, i. e. the distally facing surface and the second load transfer surface may be a proximal surface, i. e. surface facing proximally.

In an embodiment, the resilient element is a spring washer, such as a metal spring washer. Spring washers provide high forces with relatively little deformation in the axial direction.

In an embodiment, the resilient element is located on that side of the force-transmitting rigid piece that faces away from the cartridge. That is, the resilient member may be located on the proximal side of the force-transmitting rigid member. This resilient element can cooperate with the second load transmission surface of the force-transmitting part, preferably abut against this surface. The force-transmitting member may cover the resilient element upon separation of the cartridge and/or protect the resilient element from user access.

In an embodiment, it is provided that the elastic element abuts against the abutment surface of the housing, which prevents the elastic element from relative movement relative to the housing in the proximal direction. Thus, a given surface or anvil can counteract a force transmitted through the force-transmitting rigid piece to the given surface via one or more resilient members. Therefore, this surface assists in maintaining the cartridge in position.

In an embodiment, the cartridge preload system comprises a plurality of resilient members, such as two or more than two resilient members. A suitable elastic element may be a spring washer, such as, for example, a metal spring washer. A plurality of elastic elements can be functionally connected in series. By means of a plurality of resilient elements, it is possible to increase the force transmitted to the cartridge by the cartridge pressing system and/or the deformability of the cartridge pressing system in the axial direction.

In an embodiment, the force-transmitting rigid piece is made of plastic. This facilitates the economic manufacture of the part, for example by molding, for example injection molding.

In an embodiment, at least one of the resilient elements is a metal spring element, for example, only one or both of the two resilient elements is a metal spring element. Metal spring elements can be all elastic elements.

In an embodiment, the force-transmitting rigid member is located between two resilient members and/or in a load transfer path between two resilient members. Accordingly, one elastic element may be located proximal to the second load transfer surface, preferably in contact with this surface, and one elastic element may be provided distal to the first load transfer surface, preferably in contact with this surface.

In an embodiment, the force transmitting rigid member is located in the load transmission path between the two elastic elements and/or in the load transmission path between the two elastic elements and the cartridge. That is, two resilient members may be provided proximal to the second load transmission surface of the force-transmitting rigid member. One elastic element may be in contact with the second load transfer surface, and the other elastic element may be in contact with the first elastic element.

In an embodiment, the force-transmitting rigid member is located distal to the resilient element, preferably distally to at least one metal spring element or all resilient elements. Preferably, the distal surface of the force-transmitting rigid member, such as the first load-transmitting surface, may cover resilient member(s) proximal to that surface in axial and angular directions.

This design has the advantage that, in the case of detaching the cartridge from the housing, preferably only the distal surface of the force-transmitting rigid part can be seen, and the resilient element(s) can be hidden. In particular, the force-transmitting rigid member is configured to prevent a user from reaching one or more resilient members and damaging those members as a result of mishandling. Accordingly, security is increased. The metal spring element often contains sharp edges that can injure the user when touched. The force-transmitting member may prevent the resilient member(s) from being touched.

In an embodiment, the resilient element, eg one of the resilient elements, such as, for example, only one of the resilient elements, is formed in a one-piece structure with a force-transmitting rigid element. The other resilient element is suitably a metal spring element, preferably positioned proximal to the force-transmitting part. Thus, the integral part structure may comprise a rigid section for the force transmitting part and an elastically deformable section for the resilient element. The elastically deformable section may be located at the distal end of the integral part structure. By forming the resilient members integrally with the force-transmitting rigid part, which may be made of plastic, a plastic surface may be provided at the distal end of the cartridge pressing system. Accordingly, at the distal end, sharp metal edges, which are particularly easy to reach for the user when the cartridge is removed, can be avoided.

In an embodiment, a resilient element, such as one of the resilient elements, is rigidly attached to the force-transmitting rigid member. Thus, one of the resilient members, such as a metal spring member, may be provided on the distal surface, but the other resilient member is still provided proximal to the force-transmitting rigid member. Therefore, for a particular cartridge, it may be necessary to individually adapt only one elastic element of a system containing two elastic elements.

In one embodiment, one of the elastic elements, for example, only one, is rigidly attached to the force-transmitting rigid part, and/or at least one of the elastic elements is loosely attached to the force-transmitting part. "Rigidly fastened" in this context may mean that the resilient element and the force-transmitting part can be assembled with each other so that they can be handled as a single object. For example, the resilient element may be rotatably and/or axially movable with the force-transmitting member.

In one embodiment, the elastic element, for example, only one of the elastic elements or two of the elastic elements, or all of the elastic elements contain an opening, preferably a central one. The inner diameter of this hole may be larger than the outer diameter of the cartridge. Thus, the cartridge may be sized to be guided through the opening. Accordingly, although the resilient element is not sized to compress the cartridge, a force-transmitting rigid member can be used to transfer a load or force between the cartridge and the resilient element. Larger diameter resilient elements can be more easily produced, providing greater forces, for example, since more material such as metal can be used. If there are a plurality of elastic elements, a hole of a particular diameter may contain all of the elastic elements or only a part of the elastic elements. For example, the first of the elastic elements may include an opening with an inner diameter greater than the outer diameter of the cartridge, and the second elastic element, preferably provided distally to the first elastic element, may have an inner diameter less than or equal to the outer diameter of the cartridge. The last resilient element with a smaller hole diameter can be used for a mechanical stop in the cartridge, for example, in the proximal end or edge of the cartridge body.

In one embodiment, the two elastic elements contain holes of different diameters. One hole may have a diameter greater than the diameter of the cartridge and the other may have a diameter less than the (outer) diameter of the cartridge.

In one embodiment, the force-transmitting rigid member comprises one or more member connectors. By means of the part connectors, the force-transmitting rigid part can be connected to the housing, preferably in a movable manner, for example rotatably and axially movable and/or axially movable only. By means of the connecting elements, it is possible to prevent or limit the movement of the force-transmitting rigid part relative to the body in the distal direction.

In one embodiment, the cartridge preload system includes a housing contact zone in which the cartridge preload system is in contact with the housing. In the zone of contact with the housing, the cartridge pressing system may abut against the housing. The area of contact with the housing is suitably formed by an elastic element, preferably a metal spring element. The zone of contact with the housing is made with the ability to perceive the force transmitted through the cartridge compression system.

In one embodiment, the cartridge preload system includes a cartridge contact area. In the cartridge contact area, the cartridge pressing system is suitably in contact with the cartridge. In particular, in the zone of contact with the cartridge, the cartridge pressing system may abut against the proximal end of the cartridge. The contact zone with the cartridge can be formed by a force-transmitting rigid part or an elastic element of the preload system, such as one that is integrated with the force-transmitting rigid part into a one-piece structure of the part, or a separate elastic element that can be fastened with force-transmitting rigid part. Accordingly, the area of the distal surface of the force-transmitting rigid piece or elastic element can serve as the contact zone with the cartridge. The cartridge contact area and the body contact area respectively face opposite axial directions. The body contact area may face proximally and the cartridge contact area may face distal direction.

In one embodiment, the second load transfer surface and the first load transfer surface and/or the body contact area and the cartridge contact area are radially and/or axially offset.

In one embodiment, the distance in the radial direction between the cartridge contact area and the housing contact area and/or between the first and second load transfer surfaces is greater than or equal to one of the following values: 0.5 mm, 0.75 mm, 1.0 mm , 1.25mm, 1.3mm, 1.35mm, 1.375mm.

In one embodiment, the distance in the radial direction between the cartridge contact area and the housing contact area and/or between the first and second load transfer surfaces is less than or equal to one of the following values: 4 mm, 3 mm, 2.5 mm, 2.0 mm, 1.75 mm, 1.5 mm, 1.4 mm, 1.375 mm. Ranges can be formed by combining arbitrary upper limits from the previous sentence with arbitrary lower limits from the previous paragraph. For example, said distance in the radial direction may be between 0.5 mm and 4 mm.

In one embodiment, the radial distance between the cartridge contact area and the body contact area and/or between the first and second load transfer surfaces is determined by the difference in diameters, in particular outside diameters, between a standard 3.0 ml cartridge and a standard volume cartridge. 1.5 ml. In particular, this distance may be half the difference in diameters, provided the arrangement is symmetrical about the main axis of the device or cartridge. The diameter difference between the 3.0 ml cartridges and the 1.5 ml cartridges is approximately 2.75 mm (11.4-8.65 mm), where 2.75 mm/2=1.375 mm.

In one embodiment, the distance in the axial direction between the cartridge contact zone and the housing contact zone and/or between the first and second load transfer surfaces is greater than and equal to one of the following values: 1 mm, 2 mm, 3 mm, 4 mm, 5 mm , 6 mm. Alternatively or in addition, the distance in the axial direction between the cartridge contact area and the housing contact area may be less than or equal to 10 mm, 8 mm, 7 mm, 6 mm. Ranges can be formed by combining arbitrary upper limits with arbitrary lower limits from the two previous sentences.

In one embodiment, the overall length of the force-transmitting rigid member in the axial direction is suitably greater than or equal to the difference in length between the 3.0 ml cartridge and the 1.5 ml cartridge and/or one of the values defined above.

Thus, the axial extent of the force-transmitting rigid member may be greater than or equal to the difference between the length of the 3.0 ml cartridge and the length of the 1.5 ml cartridge. The length difference between these cartridges is approximately 6 mm. Accordingly, differences in the ranges defined by the above values are suitable for adapting a drug delivery device with a cartridge preload system to another cartridge, for example, from a 3.0 ml cartridge to a 1.5 ml cartridge, by means of a transfer the force of a rigid part by reusing a generally unchanged preload system. The axial displacement between the load transfer surfaces is a value significant for designing the length of the force transferring rigid piece, whereby the actual length may be greater than the length difference between the two cartridges.

Standard 3.0 ml cartridges are 11.4 mm in diameter and 64 mm long, while standard 1.5 ml cartridges are 8.65 mm in diameter and 57.8 mm long, or approximately 58 mm.

By choosing the radial and axial distances between the load transfer surfaces of the force-transmitting rigid piece according to differences in length and/or diameter, e.g. outside diameter, between two different cartridges, this facilitates the use of the same drive mechanism in combination with cartridges of different sizes without the need to remake the elastic element (elements) used in the cartridge preload system of the existing drive mechanism. A force-transmitting rigid piece can be used as a spacer to accommodate differences in length and diameter, and is applied as needed for a particular cartridge. Alternatively, one resilient element or all of the resilient mechanisms of an existing preload system can be redesigned for a different cartridge size, and the rest of the mechanism or most of its components can be unchanged.

In one embodiment, the force transmitting rigid member is a coupling. The actuator piston rod may be movably positioned through this sleeve. The piston rod can pass or move through the entire cartridge preload system.

In one embodiment, the housing includes a piston rod guide section. The piston rod guide section may be provided with a piston rod guide arranged to co-operate with the piston rod to guide movement of the piston rod relative to the housing. The guide section of the piston rod can be displaced in the radial direction relative to the inner surface of the body. The cartridge compression system or one or more of its elements, for example, a force-transmitting rigid part or at least a section thereof, one elastic element or two elastic elements, can be located between the inner surface of the housing and the outer surface of the guide section of the piston rod. A cavity may be formed between the outer surface of the piston rod guide section and the inner surface of the housing. Thus, a force-transmitting rigid member and/or a cartridge preload system can be provided in a certain area of the device without additional or significant space consumption. Accordingly, the free space between the guide section of the piston rod and the inner wall of the housing, which can be provided in any case, for example, to hold the existing elastic elements in the drug delivery device, can be used to accommodate a force-transmitting rigid part, for example, in order to accommodate a drug delivery device to a cartridge of reduced length and/or diameter.

In one embodiment, the cartridge is located in the cartridge holder. The cartridge holder may be connected to the housing, for example, to its distal end. Using the cartridge holder, the cartridge can be fixed relative to the housing. The cartridge may preferably be permanently fixed in the cartridge holder. That is, a cartridge assembly may be provided, comprising a cartridge and a cartridge holder, where the cartridge is fixed in the cartridge holder. The cartridge assembly may be provided as a single disposable item. The cartridge assembly may be a consumable item for a drug delivery device. This element can be sold separately, for example, in a pharmacy. Thus, the cartridge, since it is always located in the cartridge holder, is a properly protected cartridge holder at any time after sale in a pharmacy, and it is not necessary for the user to insert it into the cartridge holder.

In one embodiment, the proximal end of the cartridge body is distally offset from the proximal end of the cartridge holder. The cartridge holder may house a section of the cartridge compression system, such as a force-transmitting rigid piece, or a one-piece piece structure, or section thereof. The cartridge pressing system may extend from the outside of the cartridge holder into the cartridge holder where the cartridge holder connects to the housing. At least one resilient element of the cartridge pressing system is preferably located outside the cartridge holder.

In one embodiment, the cartridge holder is releasably connected to the housing. Accordingly, if the last dose of drug or drug has been dispensed from the cartridge and the cartridge has been emptied, the cartridge can be replaced and the drug delivery device drive mechanism reused in combination with another cartridge. The drug delivery device may be a reusable drug delivery device.

Another aspect relates to a structure comprising two drug delivery devices, a first drug delivery device and a second drug delivery device. The first drug delivery device is the above-described drug delivery device, where the cartridge is the first cartridge, the drive mechanism is the first drive mechanism, the cartridge preload system is the first cartridge preload system. Accordingly, the first cartridge pressing system comprises a force-transmitting rigid member. The second drug delivery device includes a second cartridge, a second cartridge preload system, and a second drive mechanism. The second cartridge pressing system may not include a force-transmitting rigid member. Specifically, except for the force-transmitting rigid part, the second cartridge pressing system may be formed in accordance with the first cartridge pressing system. The second drug delivery device may also include a drive mechanism. The first cartridge and the second cartridge may have different lengths and/or diameters. The force-transmitting rigid member of the first cartridge pressing system suitably compensates or is suitable for compensating for differences in length and/or diameter between the first cartridge and the second cartridge. The second cartridge may have a greater length and/or diameter than the first cartridge.

The first cartridge and the second cartridge may contain the same drug or drugs, or different drugs or drugs, or a drug or drug of the same formulation, or different drug formulations or drug formulations. The first cartridge and the second cartridge may contain different volumes of liquid. 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 cartridges contain a liquid, for example, with different concentrations of that active pharmaceutical ingredient.

The first device and the second device may have equal internal and/or external diameters of the housing and/or cartridge holder, in particular equal maximum internal and/or maximum external diameters of the housing and/or cartridge holder. In particular, the external dimensions and internal appearance of the two devices may be the same, although the volume of liquid contained in the cartridges and/or the dimensions of the cartridges may differ.

In addition, actuators and/or dose setting mechanisms of drug delivery devices may operate in a similar manner. Thus, the user, who may already be familiar with one device, can use the second device without any negative feelings that he might have if he had to adapt to a new device having a new external shape and a new way of operating. .

Yet another aspect relates to a method for modifying a drug delivery device for use with a different cartridge. It may result in the drug delivery device discussed above. The drug delivery device to be modified includes a housing and a drive mechanism, while the drive mechanism is held in the housing. The drug delivery device comprises a second cartridge containing a drug or a drug and a cartridge pressing system configured to apply force to the second cartridge. This device can be modified for use with the first cartridge. The first cartridge may have a smaller diameter and/or length than the second cartridge. The method may include the following steps. First, the difference in length and/or diameter between the first and second cartridges is determined. A force-transmitting rigid piece can then be provided, for example manufactured, for example by injection molding. The force-transmitting part is appropriately sized to compensate for the previously determined difference in length and/or diameter between the first and second cartridges. The force-transmitting rigid part is also suitably sized to fit into the body of the device to be modified. The force-transmitting rigid member can then be incorporated into the cartridge preload system to provide a modified drug delivery device. Incorporating a force-transmitting rigid member into the cartridge preload system may include mounting the force-transmitting rigid member into the housing and/or operatively associating the force-transmitting rigid member with one or more resilient members of the cartridge preload system of the drug delivery device to be modified. Once the force-transmitting rigid member has been incorporated into the cartridge preload system, a cartridge preload system is obtained that is cooperating with the first cartridge and which can reuse the resilient element(s) of the existing cartridge preload system. Alternatively, one or more resilient members may be provided in addition to the force-transmitting member to replace one or more members of an existing cartridge preload system.

Thus, by providing a force-transmitting rigid piece in the cartridge preload system, size differences between two cartridges can be accommodated, and the drive mechanism and/or dose setting mechanism can be used in combination with different cartridges without significant or significant adaptation of the details or mechanism operation. dose setting and/or drive mechanism. In particular, the resilient members for the cartridge compression system may not require redesign since all spatial adjustment is achieved by the force transmitting part.

In a particularly advantageous embodiment, the drug delivery device comprises:

- frame;

- drive mechanism;

- a cartridge containing a medicinal product or a medicinal product, while the cartridge is held in a predetermined position relative to the housing, while the drive mechanism is configured to dispense the medicinal product from the cartridge;

- a cartridge compression system comprising at least one resilient element and at least one force-transmitting rigid part, wherein

the force-transmitting rigid part is held in the housing with the possibility of movement, while the cartridge compression system is located and configured to apply force to the cartridge to maintain the cartridge in a given position, while the specified force is created by at least one elastic element, and at the same time, the force-transmitting rigid the part is operatively connected to at least one elastic element so that the force-transmitting rigid part receives this force.

As used herein, the terms "distal" and "proximal" may refer to opposite axial directions or ends. "Distal" may refer to the direction towards the dispensing end or the end of the drug delivery device component that is or should be closest to the dispensing end of the cartridge, cartridge holder or drug delivery device. "Proximal" may refer to away from the distal or dispensing end or an end that is or should be further away from the distal or dispensing end of a cartridge, cartridge holder, or drug delivery device.

The terms "axial", "radial", and "angular" or "azimuth", as used herein, may be used to refer to the major longitudinal axis of a device, cartridge, housing, or cartridge holder, such as an axis through the proximal and distal ends. cartridge, cartridge holder, housing or drug delivery device.

The above elements, in combination with various aspects or embodiments, should not be considered as referring only to the listed aspect or embodiment. Rather, these elements are also applicable to other embodiments or aspects. For example, elements described in conjunction with said device are also applicable to said construction and/or said method, and vice versa. Of course, the elements described in specific embodiments both above and below can also be used in combination with other and/or other elements from other embodiments or aspects.

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

In FIG. 1 shows a schematic sectional view of a section or area of an embodiment of a drug delivery device.

In FIG. 2, based on a schematic perspective view, shows an embodiment of the cartridge preload system used in the device.

In FIG. 3 is a perspective view of a component of the cartridge preload system, a force-transmitting rigid member.

In FIG. 4 shows part of the section shown in FIG. 1 with highlighted areas.

In FIG. 5 is a perspective view of the body or body of the device.

In FIG. 6 is a sectional view of a body or body part.

In FIG. 7A and 7B show an assembly method in which the force-transmitting rigid piece is assembled with a body portion or body, where in FIG. 7A shows an exploded state, and FIG. 7B shows the assembled state.

In FIG. 8 shows a schematic sectional view of an embodiment of the body portion.

In FIG. 9 is a perspective view of an embodiment of a force transmitting rigid member.

In FIG. 10 and 11 show different perspective views of the housing shown in FIG. eight.

In FIG. 12A shows the force transmitting part before it is installed in the body part, and FIG. 12B shows the situation after the part has been installed.

In FIG. 13 is a perspective view of the force transmitting part with which the resilient element is assembled.

In FIG. 14 is a schematic sectional view of a section or area of an embodiment of a drug delivery device.

In FIG. 15A and 15B show the structure of the part in a deformed state based on a perspective view - FIG. 15B and in the undeformed state in FIG. 15A.

In FIG. 16 is a schematic sectional view of an embodiment of a drug delivery device.

Like elements, elements of the same type, and elements of the same effect may be referred to in the drawings by the same reference numerals.

Below in combination with FIG. 1-7B describe an embodiment of a drug delivery device and, in particular, an embodiment of a cartridge preload system or design. As seen in the area of the drug delivery device 1 shown in FIG. 1, the drug delivery device 1 includes a cartridge 301, a cartridge holder 302, and a body portion 350. The cartridge 301 is held and positioned in the cartridge holder 302. The cartridge holder 302 may contain the entire cartridge 301. The length of the inside of the cartridge holder may be greater than the length of the cartridge. The cartridge 301 may be permanently attached to the cartridge holder 302 such that the cartridge assembly comprising the cartridge 301 and the cartridge holder 302 may form a consumable item. This consumable item can be sold at a pharmacy. The cartridge holder 302 is preferably releasably connected to the body 350, for example by a threaded or bayonet type connection. The body part 350 may be an outer body of the drug delivery device or an additional part which is preferably locked in the axial direction and rotation in the body 10 of the drug delivery device, preferably an outer body. The housing 10 holds the components of the dose setting mechanism and/or the drive mechanism of the drug delivery device 1. The cartridge 301 holds the drug or drug 307, preferably a liquid drug formulation. At the proximal end, i.e., the end of the cartridge 301 opposite the distal end through which medicament 307 can be dispensed from the cartridge, the interior of the cartridge 301 is closed by a movable plug or plug 360. The plug seals the cartridge proximally appropriately. Provided that fluid communication is provided between the inside and outside of the cartridge, for example, by means of a needle piercing the membrane of the cartridge at the distal end (not shown), the plug 360 is moved distally relative to the cartridge body 340 to dispense drug 307 from the cartridge . The drug delivery device 1 is preferably a variable dose device in which the dose of drug to be dispensed from the device can be set by the user rather than pre-set by device design as in the case of a fixed dose device. The proximal direction in FIG. 1 is the right direction and the distal direction is the left direction.

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 drug 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 vessel 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. 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 mellitus, 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 added and/or substituted amino acid residue 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, wherein the proline at position B28 is replaced by Asp, Lys, Leu, Val or Ala and at the same time at position B29 Lys 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-(ω-carboxyheptadecanoyl)-des(B30) human insulin; and B29-N-(ω-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 gonadotropins (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.

The drive mechanism held in the housing 10 or housing 350 includes a piston rod 5, such as a lead screw. It is also possible to use other types of piston rods, such as a toothed rod, etc. The piston rod 5 may be positioned to drive the plug 360 distally relative to the cartridge body 340. During drug delivery, the piston rod 5 can rotate relative to the housing. Accordingly, at its interface with the plug 360, the piston rod 5 may be provided with a bearing 6, the piston rod 5 being rotatable with respect to the bearing 6, which may be connected or axially fixed on the piston rod 5. Thus, when the bearing 6 is in contact with the plug 360, rotational movement of the piston rod 5 relative to the plug can still be possible without the need to consider friction between the piston rod and the plug. Of course, alternatively, a piston rod with a different design can be provided. For example, during dose delivery, the piston rod can only move in the axial direction.

The drive mechanism may further comprise a mechanism that transmits a user-applied force from a device drive button or handle (not shown), which forms a user interface, to the piston rod 5. The drive mechanism may further comprise a drive element or a drive sleeve 7. The drive element 7 can be configured to rotate and/or move in the axial direction relative to the piston rod 5 in the proximal direction during dose setting and/or transfer to the piston rod of the force necessary to causing distal movement of the piston rod during dose delivery. The drive element 7 can be connected to the nut 9 of the last dose. The outer surface of the drive element 7 may be provided with a thread 8 which can engage with the nut 9 of the last dose. The last dose nut can act as a follower to keep track of how much medicament has already been dispensed from the device and, when the end position relative to the actuator is reached, prevent a dose from being set in excess of the amount of medicament 305 still remaining in the cartridge 301. Thus , the last dose nut can move relative to the actuator during dose setting, but remains in place relative to the actuator during dose delivery. This causes the last dose nut to move towards its end position relative to the drive element as the cartridge is emptied. In the final position, the dose increase may be blocked. This indicates that the cartridge is empty. Thus, after the available drug has been dispensed, the cartridge holder can be separated from the housing and a new cartridge assembly or cartridge can be connected to the housing.

The piston rod 5 is, for example, threadedly engaged with the piston rod guide section 361 of the body part 350 or the body 10. The piston rod 5 can be threadedly engaged with the body 10, 350 by means of one or more threaded elements provided on the inner surface of the guide section 361 piston rod. Accordingly, the relative rotation between the piston rod and the housing causes the piston rod to move in the axial direction. Thus, the drive element can transmit force to the piston rod, which causes the piston rod to rotate relative to the body during dose delivery.

A cavity or space 362 may be formed between the piston rod guide section 361 and the inner surface of the housing. The cavity 362 may provide an area in which components of the cartridge compression system can be located without significantly obstructing the drive mechanism.

An embodiment of the cartridge compression system 400 is described below. The cartridge pressing system 400 includes a force-transmitting rigid piece 401, for example, made of a plastic material. The cartridge compression system 400 further comprises at least one suitably separate resilient member 402 in addition to the force-transmitting rigid member. The elastic element 402 may be a spring element, such as a metal spring element. For example, the elastic element 402 is a spring washer. The force transmitting rigid member 401 may be located between the at least one resilient element and the cartridge. In the embodiment discussed in conjunction with FIG. 1-7B, the cartridge preload system includes a second separate resilient member 403. The second resilient member may be a spring member such as a metal spring member such as a spring washer. The spring washers 402, 403 may be positioned such that portions of the concave shaped surfaces such as the spring washer of the spring washers face each other, maximizing axial deformability and/or force transmitted by the cartridge preload system.

In the embodiment depicted in FIG. 1 and 2, first and second resilient members 402, 403 are positioned proximal to the force transmitting rigid member 401. Thus, the force transmitting member 401 is positioned between the first resilient member and the cartridge, and between the second resilient member and the cartridge. Through the force-transmitting rigid member, an axially directed force can be transmitted from the resilient members to the cartridge to force the cartridge 301 distally at a predetermined position relative to the cartridge holder. This makes it possible to maintain the cartridge in a given relative position and improves the accuracy of the dose.

The cartridge pressing system 400 includes a cartridge contact area 404 . The contact area with the cartridge is formed by the area of the distal surface, that is, the surface facing in the distal direction of the cartridge preload system. The cartridge preload system 400 further comprises a body contact area 405 in which the cartridge preload system is in contact with the body. The body contact area 405 may be formed by the proximally facing surface of the cartridge preload system. The contact zones 404, 405 allow the cartridge compression system to be in mechanical contact with the cartridge, for example, through the proximal edge of the cartridge body, and the elastic element or elastic elements can be elastically urged, moving the cartridge in an axial direction relative to the body, during cartridge attachment, for example, by attaching cartridge holder 302 to body 350 or body 10. In the embodiment shown in FIG. 1 and 2, the cartridge contact area 404 is formed by the force-transmitting rigid member 401 and the body contact area 405 is formed by one of the resilient members 402, 403, such as the more proximal one if there are two resilient members, or by one resilient member if there is only one. , which is also possible. The force-transmitting rigid member 400 may be wholly or only partially accommodated in the cartridge holder 302. Accordingly, the outer diameter of the force-transmitting rigid piece may be smaller than the inner diameter of the cartridge holder 302. The holes of the elastic elements may have equal inner diameters. The hole of the corresponding elastic element may have a diameter greater than the outer diameter of the cartridge at the proximal end.

The force-transmitting rigid part is movable in the axial direction relative to the body, while the elastic element (elements) is elastically deformed (deformed) when it is moved proximally and can return to its original state when the part is moved distally, for example, when replacing the cartridge. The movement of the force-transmitting rigid part in the axial direction relative to the body can be limited, in particular in the distal direction and/or proximal direction. In the distal direction, this can be done by a stop surface provided on the body or body portion, which prevents the force-transmitting rigid part from falling out of the body or body portion when the cartridge holder 302 is detached.

The first elastic element 402 may come into mechanical contact with the force-transmitting rigid part 401, the second elastic element 403 may come into mechanical contact with the first elastic element and be located with the possibility of contact with the housing in the zone 405 of contact with the housing. The force generated by the deformation of the elastic elements, when the cartridge pushes the force-transmitting part proximally, while this force acts in the distal direction, is transmitted to the cartridge through the force-transmitting rigid part and to the housing through one of the elastic elements. This maintains the resilient element(s) under pressure when the cartridge is connected to the body, with the resilient force being received by the body and cartridge.

The piston rod 5 can extend and be guided through the resilient element(s) and the force-transmitting rigid piece 401. Thus, the force-transmitting piece and/or elastic elements can be positioned radially outwardly relative to the piston rod. The force-transmitting member and/or resilient element(s) are also preferably disposed in a radially outward direction relative to the piston rod guide section 361 of the body portion 350. They may suitably be located in a cavity 362 defined between the piston rod guide section and the inner surface of the body. Thus, although a force-transmitting rigid member 401 is provided, significant additional sealing space may not be required.

The force-transmitting rigid member is preferably not or is not substantially compressible under the axially directed normal force that occurs when the cartridge is connected to the housing by the latch or holder 302.

The cartridge contact zone 404 and the housing contact zone 405 may be axially and radially offset. The offset in the radial direction may correspond to a difference in radius or diameter between a 3.0 ml cartridge and a 1.5 ml cartridge.

A standard 3.0 ml cartridge has an outer diameter of 11.4 mm and a length of 64 mm, and a standard 1.5 ml cartridge has an outer diameter of 8.65 mm and a length of 57.8 mm, or approximately 58 mm. Accordingly, the offset in the radial direction between cartridge contact area 404 and body contact area 405 may be approximately 1.375 mm.

If in doubt, the centers of the respective contact zones can be taken as the reference for determining the distance when viewed in a sectional view perpendicular to the main axis of the device. Alternatively, the radial inner end of the housing contact zone and the radial outer end of the cartridge contact zone can be used to determine the distance.

The force-transmitting rigid member may form a spacer used to adapt an existing drug delivery device mechanism to a cartridge having a reduced length and/or diameter, such as when a mechanism designed for a 3.0 ml cartridge is to be used in combination with a cartridge. 1.5 ml. The cartridges may contain the same drugs or drug formulations or different drugs or drug formulations. For example, a 1.5 ml cartridge may contain the same drug but at a different concentration, such as insulin at a higher concentration than the 3.0 ml drug. Thus, in the depicted embodiment, the cartridge may be a 1.5 ml cartridge. If a 3.0 ml cartridge is used, the rigid part can be omitted or a shorter part can be used.

Due to the dimensions of the force transmitting rigid part 401, the difference between the length and diameter of the 1.5 ml cartridge and the 3.0 ml cartridges can be compensated. In FIG. 1, the difference in radius (half the diameter) is depicted with ∆ _R , and the difference in length is depicted with ∆ _L . The length of the force-transmitting piece can be determined from the difference in length between the 3.0 ml cartridge and the 1.5 ml cartridge, or may be longer. However, the axial distance between the load transfer or interface surfaces of the part where the part mates with another element, such as a resilient element on the proximal side, and the cartridge on the distal side is appropriately equal to the length difference, even if the part itself is longer.

Therefore, with the exception of the force-transmitting part, the cartridge preloading system can remain unchanged, and in particular, there is no need to change the dimensions of the springs. The inside diameter of the opening in the resilient element(s) can match the diameter of the 3.0 ml cartridge, so the corresponding element can be used to abut against the proximal end of the cartridge body in the 3.0 ml cartridge. Thus, components that have been tested for functionality in a device with a 3.0 ml cartridge can also be used in combination with a device with a 1.5 ml cartridge. The appearance of devices can remain the same regardless of the cartridge held inside them. The inner diameter of the hole in the elastic element(s) can match the diameter of the 3.0 ml cartridge, so the corresponding element can be used to abut against the proximal end of the 3.0 ml cartridge.

The requirement to provide sufficient clamping force for a range of strain values, for example as a result of changes in manufacturing tolerances, means that a minimum amount of energy must be stored in the elastic elements of the clamping structure or system. This requirement for energy storage is easier to satisfy with larger diameter springs - due to the larger volume of metal contained in them - than with smaller diameter springs. The additional available diameter also potentially reduces the axial space required for the compressing structure. In a conventional pen, sealing space will be deficient near the axis of the device due to the presence of a dispensing or actuating mechanism (eg, bearing, piston rod, piston rod guide section, actuator, and/or last dose nut). The use of a spacer or force-transmitting rigid piece to "exit" to a larger diameter allows the use of metal preload springs having a larger diameter than the aforementioned components. This allows the cartridge clamping structure to wrap around the aforementioned components rather than requiring an axial gap between them. This advantage does not depend on whether the device is adapted to a cartridge of a different shape or size or not.

In FIG. 4 shows that the cartridge preload system may be limited to an area outside the area in which the drive mechanism elements or guide elements associated with the drive mechanism elements are located. In particular, the shaded area "A" is the area in which the preload system is located, and the area "B" is the area in which the drive mechanism is located. For simplicity, in FIG. 4 shows only the upper half of the device 1, whereby the device may be symmetrical with respect to the main longitudinal axis X of the device.

In order to compensate for the difference in length between different cartridges, the axial distance between the load transfer surfaces of the force transmitting rigid part must be determined from the difference in length or must be equal to this difference. In the embodiment shown in FIG. 3, the distal load transmission surface 407 of the force transmitting part 401 is formed in the region of the cartridge contact area 404 . However, as will be shown below, the force-transmitting member does not necessarily abut against the cartridge, so the cartridge contact zone and the distal load-transmitting surface do not necessarily coincide. The proximal load transfer surface 406 may be formed by the proximal end of the force transmitting part, which may be an end mechanically abutting the first resilient member 402. As shown in FIG. 3, the force transmitting part 401 is in the form of a clutch. The inwardly directed flange at the distal end may provide a load transfer surface 407 and/or a support zone 404 for the cartridge.

As previously discussed, the force-transmitting piece 401 is suitably assembled with the body or body piece 350. One or more connecting members 408 are provided for this purpose. FIG. 3 shows only one connecting element 408, although preferably a plurality of them are provided. For example, another connecting element 408 may be provided in a diametrically opposite position relative to the depicted connecting element. In addition, more than two connectors 408 may be provided that are evenly distributed in the angular or azimuth direction.

The corresponding connecting element 408 may be a snap or clamp element. To provide flexibility in the radial direction, the flange may have a reduced extent in the radial direction in the area overlapping the connecting element 408 in the angular direction, but separated from it in the axial direction. Alternatively or additionally, to increase flexibility, the thickness of the side wall of the piece 401 may be reduced where the wall is angularly aligned with the connector. Thus, recess 409 can extend proximally and/or distally away from the connector. FIG. 3 shows only the distally extending recess 409.

The connecting member may extend radially inwardly from the force-transmitting part into a hole in the part through which the piston rod can pass. The force transmitting part further comprises guiding or stabilizing elements 410, such as ribs, extending in the axial direction. A radially inward facing surface of a suitable guide or stabilizing member may fit against a radially outward facing surface of the body portion 350, such as the outer surface of the piston rod guide section 361, to radially stabilize the position of the force transmitting member 401 assembly. Accordingly, the guide members 410 properly abut against the housing when the cartridge cartridge holder has been detached from the housing and/or when the cartridge holder is connected to the housing. In particular, the guide elements can act in conjunction with the body at any axial position of the force-transmitting part relative to the body after the part has been assembled with the body. By means of a connecting element 408 or a plurality of connecting elements, the force-transmitting rigid piece 401 can be installed in the housing, for example, with limited movement in the axial direction and/or with a blocked possibility of rotation.

In FIG. 5 shows the body part 350, while in FIG. 6 is a sectional view of the body portion 350 shown in FIG. 5 with a piston rod guide section 361 and a cavity 362. The body portion 350 is seen to include an opening 363 extending radially from the outer surface of the body towards the interior, for example, into the cavity 362. The opening 363 is configured to engage with connecting or guide elements 415 of one or both of the elastic elements 402 and 403. For example, these guide elements 415 may be located or may be held in the specified hole to limit movement in the axial direction and/or rotation of the corresponding elastic element relative to the housing. In FIG. 6 also shows that the body portion 350 is provided with a connecting element 364 or a plurality of connecting elements 364. The location of the connecting elements 364 is preferably consistent with one of the connecting elements 408 of the force-transmitting part. In the exemplary embodiment depicted in FIG. 6, the corresponding connecting element 364 may be a notch. The proximally directed surface defining the boundaries of the notch distally may form a distal stop for moving the force transmitting member 401 relative to the body portion 350. so that the angular position of the connecting elements 408 and 364 coincide before assembling the force-transmitting part and the body part using relative movement in the axial direction. This is shown in FIG. 7A, which shows the situation just before assembly of the force transmitting part 401 with the body part 350, with the arrow indicating movement in the axial direction. In FIG. 7B shows part 401 in an assembled state. For illustrative purposes, additional components such as elastic element(s) are not shown. During assembly, connector 408 may flex radially outward, which is acceptable, and upon reaching connector 364, flex back, radially inward, such that the distally facing surface of connector 408 may abut against the proximally facing surface of body portion 350, which defines the cutout boundaries. as a connecting element 364 distally. Snap-in elements or clamping elements for connection between the part 401 and the body part 350 can be built into the part using injection molding, preferably low cost injection molding, such as open mold injection molding without the use of complex injection molds, for example, injection molds, containing shutters or sliders, which significantly increase the cost of injection molds.

The connector 364 may overlap in the axial and/or azimuth or angular direction with the opening 363. The connector 364 may be radially offset relative to the opening 363. part 350. Since the body is complicated anyway, and tooling already involves significant overhead, the additional slider is not as costly. The connecting elements can also be made in another way. This modification of the embodiment discussed above is discussed below in conjunction with FIG. 8-12V.

Since, in this embodiment, the force-transmitting part is located distally to all elastic elements of the preload system, these elements are not visible to the user and/or cannot be independently changed after removal of the cartridge.

The force-transmitting rigid member may also be connected to the housing in other ways. One possibility is illustrated in conjunction with FIG. 8-12B, with only differences from the previous embodiment being considered. Here, the connectors 364 on the body portion 350 are formed by one or more snap-on elements rather than notches. The proximal surface of the corresponding connecting element 364 defines the boundaries of the hole 365 protruding in the radial direction through the outer wall of the guide section 361 of the piston rod in the distal direction. Connecting members 364 of this kind may be formed by ribs on an injection mold stud used to define the interior of the piston rod guide section 361. These ribs may protrude radially from the shaping pin. The force-transmitting part 401 in this case comprises a circumferentially extending flange as connecting element 408 . Thus, unlike the previously described embodiment, when the part 401 is assembled with the body part 350, the proper rotational alignment of the part 401 and the body part is not important. It is clear that after assembly, as shown in FIG. 12B, the distally facing surface of the connector 408 is adapted to abut against the proximally facing surface of the (corresponding) connector 364. The flexibility required for attachment can be at least partially provided by reducing the axial thickness of the latch nose of the connector 408, which can flex. in the axial direction during the assembly process. The necessary force can be applied by means of an inclined proximally facing surface of the connecting element 408 in contact with the housing during the assembly process. Two resilient element springs may be located on the proximal side of the force-transmitting rigid member, or only one spring or resilient element may be used. In general, the elements described in conjunction with various embodiments may be combined with or substituted for each other, as the case may be.

Another embodiment of the cartridge preload system is shown in FIG. 13 and 14. Only the differences from the previously described embodiments are discussed below. In FIG. 13 is a perspective view of the force transmitting rigid member 401. FIG. 14 is a cross-sectional view of a drug delivery device 1 most closely related to the device discussed in conjunction with FIG. 1. As seen in FIG. 13, the cartridge pressing system includes a subassembly comprising or consisting of a force transmitting part 401 and a spring member as a second resilient member 403 assembled with the housing. The diameter of the resilient member 403 can be adapted to the diameter of the cartridge so that the spring can abut the cartridge on the proximal side, as shown in FIG. 14. The distal load transmission surface 407 of the force-transmitting part in this case may be formed by the distal surface of the mounting member by which the resilient member 403 is mounted on the force-transmitting part 401. Thus, a spring member such as a spring washer can be used to pressurize the cartridge. distally. The resilient member 403 may be clamped into the force transmitting part so that the resilient member 403 can be positioned in the interior of the force transmitting member. Thus, the area 404 of contact with the cartridge can be formed by the distal surface of the elastic element 403, as shown. The remaining functionality may be the same as previously described in conjunction with other embodiments.

The location of one of the resilient elements at the distal end or distal side of the force-transmitting part means that the movement in the axial direction required for the force-transmitting part will be reduced. The force-transmitting part only needs to move a distance sufficient to generate the deformation required for one of the elastic elements, and not the sum of the axial deformations required for both elastic elements, as in the case when both elements were located on the proximal side, as in the embodiment shown in FIG. 1. This may provide an advantage in the design of the connection of the force transmitting part with the body part 350.

Alternatively, as will be discussed in conjunction with the following embodiment, the force transmitting part may be combined into one integral part structure along with one resilient element. This embodiment is discussed below in conjunction with FIG. 15A-16, while also considering only the differences from the previous embodiments. In this case, a one-piece structure 411 of a part, for example, made of plastic, integrates a force-transmitting rigid part 401, as well as an elastic element 403. The elastic element 403 is located at the distal end of the force-transmitting rigid part 401. Thus, the distal surface 407 of the load transmission can be formed by a transition the area of the part structure 411 between the elastic element 403 and the part 401. The diameter of the elastic element 403 may correspond to the diameter of the cartridge body at the proximal end. The inner diameter of the force transmitting member 401 may be larger than the outer diameter of the second resilient member 403. The resilient member may be connected to the force transmitting member, but may include an intermediate space relative to the force transmitting member to provide resiliency. The elastic element 403 may be formed as an annular with two different connections 412 in the form of bridges with force transmitting part 401. At the distal end of the elastic element 403 may be provided with one or more rigid elements 413 for contact with the cartridge. They may protrude axially from the annular structure of the resilient member 403 and, when the cartridge holder 302 is connected to the body portion 350, abut against the proximal end or edge of the cartridge 301.

As shown in FIG. 16, a resilient element 402 is present, such as a metal spring element such as a washer, as previously discussed. Combining one of the resilient members into a part design along with a force-transmitting rigid part reduces the number of components needed and can also simplify the assembly process when assembling the cartridge preload system. In the corner region(s) between joints 412, one or more flexible regions 414, such as arcuate regions, of elastic member 403 may be formed. These flexible regions may also be referred to as flexible arms 414. In FIG. 15A shows the flexible arms 414 in an unbent state, and FIG. 15B they are shown in a bent state in which, for example, the proximally facing surface of the flexible arms may be in contact with the distal surface of the force transmitting member. Once the cartridge holder has been connected to the body, the flexible arms may deform, as can the resilient member 402, as shown in FIG. 15V.

The scope of protection is not limited to the examples discussed earlier in this document. Any invention described 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 the examples.

Reference positions

1 drug delivery device

5 piston rod

6 bearing

7 drive clutch

8 thread

9 nut last dose

10 building

301 cartridge

302 cartridge holder

307 medicine/drug

340 cartridge body

350 body part

360 cork

361 piston rod guide section

362 cavity

363 hole

364 connector

365 hole

400 cartridge preload system

401 force transmitting rigid part

402 first spring

403 second spring

404 cartridge contact area

405 body contact area

406 load transfer surface

407 load transfer surface

408 connector

409 recess

410 guide element

411 part design

412 connection

413 cartridge contact element

414 flexible arm

415 connecting/guiding element

Region A

Region B

X axis

Claims (32)

1. A drug delivery device (1), comprising: - housing (10, 350); - drive mechanism (5); - a cartridge (301) containing a drug (307), while the cartridge is held in a predetermined position relative to the housing, and the drive mechanism is configured to dispense the drug from the cartridge; - a system (400) for preloading the cartridge, containing at least one elastic element (402, 403) and at least one force-transmitting rigid part (401), while the force-transmitting rigid part is held in the housing with the possibility of movement, while the cartridge compression system is located and configured to apply force to the cartridge to maintain the cartridge in a given position, while the specified force is created by at least one elastic element, and the force-transmitting rigid part is functionally connected with at least one elastic element so that the force-transmitting rigid part perceives this force, and the cartridge (301) is located in the cartridge holder (302) connected to the housing, while the cartridge compression system (400) extends into the cartridge holder. 2. The drug delivery device according to claim 1, characterized in that at least one elastic element (402, 403) contains a central hole, while the inner diameter of the said hole is larger than the outer diameter of the cartridge (301). 3. The drug delivery device according to claim 1 or 2, characterized in that the cartridge compression system (400) comprises two resilient elements (402, 403). 4. The drug delivery device according to claim 3, characterized in that the force-transmitting rigid part is located in the load transmission path between the two elastic elements. 5. The drug delivery device according to claim 3, characterized in that the force-transmitting rigid piece (401) is located in the load transmission path between the two resilient members (402, 403) and the cartridge. 6. The drug delivery device according to any one of paragraphs. 3-5, characterized in that one of the elastic elements (403) is formed in a one-piece structure (411) of a part with a force-transmitting rigid part (401). 7. The drug delivery device according to any one of paragraphs. 3-5, characterized in that one of the elastic elements (403) is rigidly fastened to the force-transmitting rigid part (401). 8. The drug delivery device according to any one of the preceding claims, characterized in that the cartridge preload system (400) comprises a housing contact zone (405), in which the cartridge preload system is in contact with the housing (10, 350), and a zone ( 404) contact with the cartridge, in which the cartridge preload system is in contact with the cartridge (301), while the contact area with the housing and the contact area with the cartridge are offset in the radial and axial directions. 9. The drug delivery device according to claim 8, characterized in that the distal surface (407) of the force-transmitting rigid part (401) contains a zone (404) of contact with the cartridge. 10. The drug delivery device according to claim 8, characterized in that the distal surface of the elastic element (403) or one of the elastic elements contains a zone (404) of contact with the cartridge. 11. The drug delivery device according to any one of paragraphs. 8-10, characterized in that the distance in the radial direction between the cartridge contact zone (404) and the housing contact zone (405) is greater than or equal to 0.5 mm and less than or equal to 3.0 mm. 12. The drug delivery device according to any one of paragraphs. 8-11, characterized in that the distance in the radial direction between the zone (404) of contact with the cartridge and the zone (405) of contact with the body is determined by the difference between the diameter of the cartridge with a volume of 3.0 ml and the diameter of the cartridge with a volume of 1.5 ml, and at the same time axial the length of the force transmitting rigid part (401) is greater than or equal to the difference between the length of the 3.0 ml cartridge and the length of the 1.5 ml cartridge. 13. The drug delivery device according to any of the preceding claims, characterized in that the rod (5) of the piston of the drive mechanism is adapted to move through the force-transmitting rigid part (401), while the housing contains a guide section (361) of the piston rod, which is provided with a guide a piston rod member acting in conjunction with the piston rod to guide movement of the piston rod relative to the housing (10, 350), wherein the piston rod guide section is radially displaced relative to the inner surface of the housing, and at least one section of the force-transmitting rigid piece is located between the outer surface of the piston rod guide section and the inner surface of the housing. 14. The drug delivery device according to any one of the preceding claims, characterized in that the drug (307) in the cartridge is a drug. 15. A set of drug delivery devices, comprising two drug delivery devices, a first drug delivery device (1) and a second drug delivery device (1), wherein the first drug delivery device is the drug delivery device according to any one of the preceding claims, wherein the cartridge is a first cartridge, the drive mechanism is a first drive mechanism, and the cartridge preload system is the first cartridge preload system, wherein the second drug delivery device comprises a second cartridge, a second cartridge preload system and a second drive mechanism, wherein the first cartridge and the second cartridge have different lengths and/or diameters, wherein the force-transmitting rigid member (401) of the first cartridge preload system compensates or is suitable for compensating for differences in length and/or diameter between the first cartridge and the second cartridge. 16. A method for modifying a drug delivery device (1) containing: body (10, 350); a drive mechanism, wherein the drive mechanism is held in the housing; a second cartridge containing a drug (307); and a cartridge pressing system configured to apply force to the second cartridge, wherein the drug delivery device is modified for use with a first cartridge (301) of smaller diameter and/or length compared to the second cartridge, and the method for modifying the drug delivery device includes the following steps: - determining the difference in length and/or diameter between the first and second cartridges; providing a force-transmitting rigid piece (401) sized to compensate for said difference; and - embedding a force-transmitting rigid part in the cartridge compression system (400) to obtain a modified drug delivery device (1).

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