HK1160804B - Drug delivery device and method of manufacturing a drug delivery device - Google Patents

Description

Drug delivery device and method of manufacturing a drug delivery device

Technical Field

The present invention relates to a drug delivery device (drug delivery device) and a method of manufacturing a drug delivery device. Drug delivery devices are used for drug delivery, such as insulin, heparin or growth hormone, and the like. Some devices are designed to deliver multiple doses. Furthermore, some devices are designed to allow setting of different dose sizes of the drug being delivered. Here, it is important that the size of the dose can be accurately set and that the set dose can be reliably delivered.

Background

In US 2007/0021718a1, a syringe is shown in which a spring is provided between the housing insert and the drive element. The spring may act as a compensation for longitudinal tolerances (longitudinal tolerances) to support the medicament container within the injection device.

In US 3,742,948, a syringe with a pressure part manufactured as a disc spring (cup spring) is shown. The pressure member includes a recoverable flange (restitution projections) which is provided with a free end at the upper edge of the liquid container.

Further drug delivery devices are known from WO 2005/032449a1 and DE 102004053529 a 1.

Disclosure of Invention

It is an object of the present invention to provide an improved drug delivery device. In particular, a drug delivery device with improved operability for dose control and/or improved dose repeatability for different cartridges (cartridges) is provided.

For this purpose, the drug delivery device comprises a housing having a proximal end and a distal end, a cartridge adapted to contain a drug, a cartridge retaining member (cartridge retaining member) adapted to retain the cartridge, the cartridge retaining member being fastened to the housing, and a spring washer (spring washer) arranged within the housing to exert a force on the cartridge and to fasten the cartridge against displacement, preferably against displacement, relative to the housing.

In this type of drug delivery device, movement of the cartridge relative to the housing and/or cartridge retaining member is reduced or even eliminated due to the action of the spring washer exerting a force on the cartridge. The spring washer may reduce movement between the cartridge and the housing and/or between the cartridge and the cartridge retaining member. This is particularly advantageous, for example, when cartridges of different lengths are used in the drug delivery device. Thus, the drug delivery device may be a reusable device. Manufacturing tolerances (manufacturing tolerances) in the cartridge length can thus be compensated by the spring washer arrangement. Thus, during operation of the drug delivery device, axial movement of the cartridge within the cartridge retaining member may be reduced or even prevented and dose accuracy increased. The spring washer allows the cartridge to be secured in the cartridge retaining member without taking up much space. Thus, a very compact drug delivery device may be formed.

In another embodiment, the spring washer is arranged adjacent to the cartridge, preferably on the side of the cartridge facing the proximal end of the housing.

The spring washer may hold the cartridge fixed in the cartridge holding part by abutting the cartridge, preferably on a side of the cartridge facing the proximal end of the housing. Thus, axial movement of the cartridge relative to the cartridge retaining member is reduced or even prevented.

The spring washer may exert a force on the cartridge in a distal direction. The spring washer may be loaded or biased to exert a force on the cartridge.

In another embodiment, the spring washer is secured to the housing. In particular, the spring washer may be secured to the housing to prevent relative axial movement of the spring washer and the housing in the region where the spring washer is secured to the housing.

According to this embodiment, the reaction force of the force exerted by the spring washer on the cartridge acts on the housing, while the spring washer is held in its axial position.

In one embodiment, the drug delivery device comprises a piston rod for dispensing the drug from the device when the piston rod is driven in the distal direction, and the spring washer comprises an opening arranged to allow the piston rod to run through the opening.

In this embodiment, the spring washer may conveniently be implemented with conventional drug delivery mechanisms using a piston rod or the like. Thus, the manufacturability of the drug delivery device is facilitated, since no significant design changes need to be made.

According to another embodiment, the spring washer is curved in the axial and/or radial direction. The shaft may extend between the proximal and distal ends of the housing.

Shaping the spring washer in this way facilitates loading of the spring washer and application of force to the cartridge.

In another embodiment, the spring washer is a Belleville type (Belleville type) spring washer.

A spring washer of this type may be conveniently implemented in a drug delivery device.

In one embodiment, the spring washer is secured to a sleeve member (sleeve member) of the housing, which is preferably a threaded sleeve member of the housing.

According to this embodiment, the spring washer may be implemented in a conventional housing of a drug delivery device without requiring significant design changes to the housing. The (threaded) bushing member may simultaneously be used to fasten the cartridge retaining member to the housing by means such as an internal thread.

In one embodiment, the drug delivery device comprises a further washer, preferably arranged on the proximal side of the spring washer. The further washer may preferably be abutted by a spring washer.

In one embodiment, the further washer is arranged to limit a loading distance (loading distance) of the spring washer.

Upon insertion of the cartridge, a proximally directed force may be exerted on the spring washer, for example as occurs when (releasably) fastening the cartridge retaining member to the cartridge retained in the housing. In order to prevent the spring washer from being permanently plastically deformed, the further washer may be arranged on the proximal side of the spring washer. The further washer may limit the distance the spring washer may be deformed.

In one embodiment, the further washer is a disc washer (disk washer) or a spring washer. If the further washer is a spring washer, it preferably has a higher strength than the spring washer exerting a force on the cartridge. The risk of overloading a spring washer, for example in the area of plastic deformation, can be reduced by providing another spring washer with a higher spring strength if the spring washer is loaded with a certain force.

In one embodiment, the further washer is arranged to limit the deformation of the spring washer to an elastic deformation. In this embodiment, the spring properties of the spring washer may be retained without plastic deformation, i.e. without inelastic deformation.

According to another embodiment, the spring washer may be bent in the axial and/or radial direction. Preferably, the curvature (curvature) of the further washer corresponds or resembles the curvature of a spring washer.

In this example, the curvature of the further washer may be adapted to the curvature in the region where the further washer and the spring washer coincide when viewed in the axial direction. This allows a smooth abutment of the spring washer and the further washer.

To achieve the above mentioned object, a method of manufacturing a drug delivery device comprises the steps of: the method comprises the steps of providing a housing having a proximal end and a distal end, providing a cartridge adapted to contain a drug, providing a cartridge retaining member adapted to retain the cartridge, arranging a spring washer within the housing and fastening the cartridge retaining member to the housing, whereby the spring washer is loaded to exert a force on the cartridge and fasten the cartridge against displacement, in particular axial displacement, relative to the cartridge retaining member.

In order to achieve the above object, a spring washer is used to secure a drug-containing cartridge within a cartridge retaining member of a drug delivery device against displacement, preferably against axial displacement, relative to the cartridge retaining member.

Other features will become apparent from the following detailed description when considered in conjunction with the accompanying drawings.

Drawings

In the drawings:

fig. 1 schematically shows a simplified cross-sectional side view of a drug delivery device according to an embodiment;

fig. 2 schematically shows an exploded perspective view of a drug delivery device according to an embodiment;

fig. 3 schematically shows a detailed cross-sectional side view of a drug delivery device according to an embodiment;

fig. 4 schematically shows a detailed cross-sectional side view of a drug delivery device according to an embodiment;

fig. 5 schematically shows a side view of a spring washer according to an embodiment; and is

Fig. 6 schematically shows a side view of another gasket according to an embodiment.

Detailed description of the invention

In fig. 1 an embodiment of a drug delivery device 5 is shown, which is a syringe for liquid medicaments. The drug delivery device may be designed to deliver multiple doses of a drug, preferably user-set. The drug delivery device may be a pen-type device. The drug delivery device 5 comprises a housing 10 in which a cartridge 15 comprising a medical product (drug) is arranged. A needle unit 20 is located at the distal end 25 of the drug delivery device 5. The needle apparatus 20 may be secured against movement relative to the housing. Through the needle unit 20, the medical product can be injected into the patient.

It should be noted that the description of the drug delivery device 5 as shown in fig. 1 is merely illustrative.

The drug delivery device as shown in fig. 1 further comprises a cartridge retaining member 45 which is (releasably) fastened to the housing 10. The cartridge retaining member 45 is adapted to retain the cartridge 15 within the drug delivery device 5. The cartridge retaining member 45 may be designed so that the cartridge 15 may be replaced by a user after it has been depleted.

Delivery of the medical product may be performed by a piston rod 30 or similar device which is movable to a distal end relative to the cartridge 15. A piston is held in the cartridge and seals the cartridge on the proximal side, the piston (not explicitly shown) being movable in the distal direction relative to the cartridge 15. Due to the moving piston, the medical product can be delivered from the cartridge. The piston rod 30 may be threadedly engaged with a (lead screw) nut 35. During operation of the device, the nut 35 is secured against rotational movement relative to the housing 10 by a locking nut 36 (see fig. 2 and 4) which engages the nut 35. Thus, when driven distally, the piston rod may rotate and move parallel relative to the housing. The lock nut 36 and nut 35 may remain engaged when the cartridge retaining member 45 is secured to the housing 10. When the cartridge retaining member is released from the housing 10, the nut 35 and the lock nut 36 may be disengaged to allow the nut 35 to rotate relative to the housing 10. To reset the device, for example before fastening a new, unused cartridge to the housing, the piston rod 30 can then be screwed back to its initial position without this movement being hindered by the engagement of the nut 35 and the locking nut 36. Thus, resetting of the device is facilitated.

Furthermore, the piston rod 30 is conveniently connected to a drive mechanism (not explicitly shown) such as a mechanical or electronic drive mechanism and a dose setting mechanism (not explicitly shown). The drive mechanism and the dose setting mechanism are designed to set a dose of the medical product and to move the piston distally such that the set dose is dispensed from the cartridge when the dispense button 40 of the drug delivery device is pressed.

When the cartridge 15 is inserted into the cartridge holding member 45 and the cartridge holding member 45 is fastened to the housing, the distal movement of the cartridge 15 is prevented by the cartridge holding member 45. The cartridge 15 may abut the cartridge retaining member on the distal side.

On the proximal side of the cartridge 15, a spring washer 50 is arranged in the housing 10. The spring washer 50 applies a force to the cartridge 15 in the distal direction and secures the cartridge 15 against movement relative to the cartridge retaining member 45 and against movement relative to the housing 10. The loaded spring washer may keep the cartridge and cartridge retaining member permanently in abutment on the distal side of the cartridge 15. As shown in fig. 1, the spring washer 50 is arranged adjacent to the cartridge 15 on a side of the cartridge 15 facing the proximal end 65 of the housing 10. Further, the spring washer 50 includes an opening 55 to allow the piston rod 30 to pass through the spring washer 50 and drive the delivery of the medical product from the cartridge 15.

The spring washer 50 is fixed to the housing 10 to allow a force to be exerted on the cartridge 15. In order to allow for a facilitated manufacturing of the drug delivery device 5, a (threaded) bushing component 60 may be provided. The spring washer may be secured to the bushing component 60 by a securing element 52, such as on the spring washer. The securing element 52 may extend in an axial direction. The spring washer may be fixed to the bushing member 60 at an outer surface of the bushing member 60. The bushing component is fixed to the housing. The spring washer 50 may be secured to the bushing member 60 by means such as a press fit (snap-fit). The bushing component 60 and/or the spring washer 50 are conveniently secured against rotational and/or axial movement relative to the housing. It is understood that axial movements to load the spring washer or to take place in the relaxation of the spring washer are permitted. However, the spring washer is fixed to at least one region of the housing 10, e.g. the fixation element 52, preferably without rotational and/or axial movement during operation of the drug delivery device.

The spring washer 50 may be provided with one or more positioning elements. Each positioning element can be used to hold the spring washer 50 in a determined orientation, preferably a predetermined angular orientation relative to the housing 10. For example, the securing element 52 may serve as a positioning element. Each positioning element may cooperate with the housing or an element that is axially or rotationally locked to the housing to maintain the spring washer 50 in a predetermined orientation.

The respective positioning/fixing elements may be oriented in the axial direction. Each positioning/securing element may extend from the outer circumference of the spring washer. The two positioning/fixing elements may be oppositely arranged. For example, the positioning/fixing elements may be arranged in and/or guided in respective guide grooves (not explicitly shown). The guide slot may be defined axially, preferably distally and/or proximally, such that axial movement of the spring washer 50 relative to the housing 10 is limited. The guide groove cooperating with the positioning/fixing element moving in the groove may lock the spring washer 50 rotationally with respect to the housing 10.

In comparison with spring washers, it is much more difficult to rotationally lock the helical compression spring relative to the housing, since the helical compression spring is usually deformed to a greater extent under the action of external forces, in particular in the angular direction. The spring washer can maintain its shape in the angular direction even under a large force. The use of a spring washer provided with corresponding positioning/fixation elements facilitates the provision of a drug delivery device with accurately aligned components.

Cartridge retaining member 45 may be secured to housing 10 by a threaded connection provided between bushing member 60 and cartridge retaining member 45. The bushing component 60 is preferably provided with an internal thread.

Exerting a force on the cartridge 15 in the distal direction may be achieved by loading the spring washer 50 in the proximal direction when the cartridge retaining member 45 with the cartridge is mounted to the housing 10, such as by screwing the cartridge retaining member into the hub member. Thus, when the cartridge is moved into abutment with the spring washer 50 and the spring washer 50 is moved further in the proximal direction with the cartridge, the spring washer is loaded and exerts a force on the cartridge in the distal direction.

The drug delivery device 5 in the embodiment shown in fig. 1 eliminates axial movement of the cartridge 15 relative to the housing 10 and relative to the cartridge retaining member 45. This is advantageous, for example, when cartridges 15 having different lengths are used in a drug delivery device. For example, it is possible to compensate for length differences caused by manufacturing tolerances of different cartridges or the nature of different cartridge types, e.g. between 0.2 and 2mm, by using spring washers. Thus, during operation of the drug delivery device 5, axial movement of the cartridge 15 in the cartridge retaining member 45 is prevented, thus improving the accuracy of drug delivery.

It should be noted that different configurations of the spring washer 50 in different positions in the housing 10 may be used to prevent axial movement of the cartridge. For example, it is also possible to fasten the spring washer 50 to the cartridge retaining member 45 or directly to the housing 10.

To ensure that the spring washer is maintained within the range of elastic deformation, a further washer 70 may be provided on the proximal side of the spring washer 50. The further washer 70 may be a belleville washer or a spring washer having a higher strength than the spring washer 50.

The further washer 70 limits the movement of the spring washer 50 so that the spring washer 50 is not plastically deformed. Thus, the geometry of the relaxed, i.e. unloaded, spring washer 50, in particular its spring strength, remains unchanged. As shown in fig. 1, the further gasket may be shaped as a disc. It will be appreciated that the other washer may have a curvature corresponding to the curvature of the spring washer 50.

The spring washer may comprise or be made of metal. Each spring washer may be made of, for example, steel. Preferably, the spring constant D of the spring washer 50 is less than the spring constant D of the other spring washer 70.

Preferably, the further washer 70 is secured against rotation relative to the housing 10. The further washer need not be secured to the housing to prevent axial movement. Conversely, the spring washer 50 may limit distal movement of the other washer. An abutment member (not expressly shown) may limit proximal movement of the other washer relative to the housing. However, axial movement of the further washer 70 is conveniently restricted to allow the spring washer 50 to abut the further washer 70 and the further washer to abut the housing 10 before the spring washer is plastically deformed.

The embodiment of fig. 1 can now be further explained with reference to fig. 2. Fig. 2 is an exploded view of the drug delivery device 5 showing a side view of several components of the drug delivery device 5 before it is inserted into the housing 10. In fig. 2 is shown a (threaded) bushing component 60 with means 62 for clamping the spring washer 50. The spring washer 50 has two fixing elements 52, for example hook-shaped, to fix the spring washer 50 to the bushing component 60, for example by interaction of the respective fixing elements and corresponding clamping means 62.

Furthermore, a (lead screw) nut 35 and a locking nut 36 are shown in fig. 2. The further washer 70 also comprises a securing member 72 to secure the further washer against rotational and/or axial movement relative to the housing 10. The elements shown in fig. 2 are fitted to the housing 10. For example, the bushing member 60 may be laser welded to the housing 10. As can be seen immediately in fig. 2, the spring washer 50 allows the cartridge 15 to be fastened relative to the housing 10 and in the cartridge retaining portion without taking up too much space. In particular, the spring washer 50 provides a significant space savings over a helical coil spring having the same spring strength. Thus, a very compact drug delivery device 5 can be formed.

Referring to fig. 3, fig. 3 shows another embodiment of a drug delivery device 5. Fig. 3 shows a more detailed view of the spring washer and the further washer 70. As shown in fig. 3, the further gasket 70 may be designed as a disc-shaped gasket.

Referring now to fig. 4, fig. 4 shows yet another embodiment. According to this embodiment, the further washer 70 is also formed as a spring washer. The further washer 70 is curved axially and/or radially to correspond to or mimic the curvature of the spring washer 50.

Fig. 5 shows a more detailed view of the spring washer 50. The spring washer 50 is bent in the axial and/or radial direction and comprises a fixing element 52. The fixing elements 52 may be arranged opposite to each other. The spring washer may be a belleville type spring washer.

Referring now to fig. 6, fig. 5 shows another gasket 70. The further washer 70 is provided as a disc washer, wherein the securing members 72 are arranged on two opposite sides.

A method of manufacturing the drug delivery device 5 comprises providing a housing having a proximal end and a distal end, providing a cartridge adapted to contain a drug, providing a cartridge retaining member designed to retain the cartridge, arranging a spring washer within the housing, and securing the cartridge retaining member within the housing, whereby the spring washer is loaded to exert a force on the cartridge and secure the cartridge against displacement, in particular axial displacement, relative to the cartridge retaining member.

Other implementations are within the scope of the following claims. Elements of different implementations may be combined to form implementations not explicitly disclosed in this application.

Reference numerals

5 drug delivery device

10 casing

15 medicine box

20 needle unit

25 distal end

30 piston rod

35 nut

36 locking nut

40 dispensing button

45 medicine box holding member

50 spring washer

52 securing element

55 opening

60 bushing component

62 clamping device

65 proximal end

70 another gasket

72 fixing part

Claims (16)

1. A drug delivery device comprising:

a housing having a proximal end and a distal end,

a kit adapted to contain a medicament,

a cartridge retaining member adapted to retain the cartridge, the cartridge retaining member being secured to the housing, an

A spring washer disposed within the housing to apply a force to the cartridge and secure the cartridge against movement relative to the cartridge retaining member, wherein the spring washer is disposed to abut the cartridge on a side of the cartridge facing the proximal end of the housing.

2. The drug delivery device of claim 1, wherein the spring washer is biased to apply a force to the cartridge in a distal direction.

3. The drug delivery device of claim 1, wherein the spring washer is secured against axial movement relative to the housing.

4. The drug delivery device according to claim 1, wherein the drug delivery device comprises a piston rod for dispensing a drug from the device when the piston rod is driven in the distal direction, and wherein the spring washer comprises an opening arranged to allow the piston rod to run through the opening.

5. The drug delivery device of any one of claims 1 to 4, wherein the spring washer is bent in an axial and/or radial direction.

6. The drug delivery device of any one of claims 1 to 4, wherein the spring washer is a Belleville-type spring washer.

7. The drug delivery device of any one of claims 1 to 4, wherein the spring washer is secured to a threaded bushing component of the housing.

8. The drug delivery device of claim 1, comprising a further washer arranged on a proximal side of the spring washer.

9. The drug delivery device of claim 8, wherein the further washer is a belleville washer, or a further spring washer having a higher strength than the spring washer.

10. The drug delivery device of claim 8, wherein the further spring washer is arranged to limit a loading distance of the spring washer.

11. A drug delivery device as claimed in any one of claims 8 to 10, wherein the further washer is arranged to limit deformation of the spring washer to elastic deformation.

12. The drug delivery device of any one of claims 8 to 10, wherein the further washer is curved axially and/or radially to correspond with the curvature of the spring washer.

13. A drug delivery device as claimed in any one of claims 1 to 4, 8 to 10 for administration of a drug.

14. A drug delivery device according to any of claims 1-4, 8-10 for administration of insulin, heparin or growth hormone.

15. Use of a spring washer in a cartridge retaining member of a drug delivery device to secure a drug containing cartridge against displacement relative to the cartridge retaining member, wherein the spring washer is arranged to abut the cartridge on a side of the cartridge facing a proximal end of a housing of the drug delivery device.

16. A method of manufacturing a drug delivery device, comprising:

a housing is provided having a proximal end and a distal end,

a cartridge adapted to contain a medicament is provided,

providing a cartridge retaining member adapted to retain the cartridge,

arranging a spring washer in the housing, an

Securing the cartridge retaining member to the housing, thereby loading the spring washer to apply a force to the cartridge and secure the cartridge against displacement relative to the cartridge retaining member, wherein the spring washer is arranged to abut the cartridge on a side of the cartridge facing the proximal end of the housing.