HK1161851A - Drug delivery device - Google Patents

Description

Drug delivery device

Technical Field

The present invention relates to a drug delivery device. In addition, the present invention relates to covering the distal end of the drug delivery device with a cap (cap).

Background

Drug delivery devices are generally known for administering medical products such as insulin, growth hormone or other drugs suitable for self-administration. Some drug delivery devices are configured to deliver multiple doses. In addition, some drug delivery devices are configured to allow different dose sizes to be set for delivery.

EP-a1-1923084 discloses a drug delivery device wherein the drug delivery device is actuatable by a user. The drug delivery device comprises a drive mechanism adapted for a pen injector, wherein a plurality of pre-set doses of a medical product may be administered. A needle assembly may be connected with the drug delivery device to dispense a medical product into the skin of a patient. After use of the drug delivery device, the distal end of the device may be covered with a cap.

It is often appropriate that after use of the drug delivery device, the needle assembly is removed and the drug delivery device is covered with a cap after use, thereby preventing contact with the needle and/or contamination of the device.

US 2003/0191438 a1 discloses a medical needle shield comprising a shield extendible from a retracted position to an extended position, wherein the shield comprises a first segment mounted on a medical needle device having a needle extending therefrom, whereby a further segment substantially surrounds the distal end of the needle.

US 4,935,012 discloses a safety device for protecting medical personnel and the like from needle stick injuries and/or from exposure to infectious diseases or other harmful substances. The safety device comprises an elongated protective sleeve supported by a front bearing element and a rear bearing element for sliding movement around a medical needle and a support structure associated therewith.

Other safety shield systems for pen needles are described in US 2002/0133122 a1 and US2007/0293818 a 1.

Disclosure of Invention

It is an object of the present invention to provide an improved drug delivery device. In particular, the present invention provides a drug delivery device that prompts the user to remove the needle after operating the device.

For this purpose, the drug delivery device comprises a housing having a needle holder adapted to connect a needle assembly with the housing at a distal end; and a cap capable of covering a distal end of the drug delivery device and including a securing element (retaining member) capable of securing the cap by engaging with the housing, the securing element not being engaged with the housing when the needle assembly is connected with the needle holder.

In particular, the cap may be arranged to be able to cover the distal end of the drug delivery device. The cap may be an integral part. The cap may be a single injection molded part. The fixing member may be configured to fix the cap by engaging with the housing. The securing element may be arranged to secure the cap to the housing.

In said drug delivery device, the fixing element of the cap does not engage with the housing when the needle assembly is connected with the drug delivery device. Thus, the user gets feedback when trying to place the cap on the drug delivery device. This is achieved as follows: the retaining element is not engaged with the housing as long as the needle assembly is connected to the needle holder.

In addition, the risk of needle stick injuries is reduced because the cap has a configuration that abuts the needle assembly before the risk of the needle cannula piercing the distal end of the cap occurs.

In a first embodiment, the cap includes at least one protruding element on an inner surface of the cap, wherein the protruding element abuts or is disposed to abut the needle assembly, thereby preventing the securing element from engaging the housing.

The at least one protruding element on the inner surface may abut the needle assembly when the cap is attempted to be placed on the drug delivery device. The arrangement of the protruding elements is chosen such that the securing elements of the cap do not engage with the housing as the cap cannot reach its final position. At least one protruding element on the inner surface is effective to prevent further engagement of the cap with the housing by abutting the needle assembly. In addition, the cap may be designed such that a relatively short cap fits into both a long and short needle cannula. This can be achieved, for example, as follows: at least one protruding element on the inner surface is positioned near the end of the cap facing the proximal end.

In another embodiment, the at least one projecting element is shaped as a step along the inner sidewall of the cap.

According to this embodiment, the protruding element can be easily implemented in the cap. Thus, the design of the cap is simplified and conventional techniques can be used to manufacture the cap. For example, a cap in the form of a single injection molded part may be provided which is manufactured from a thermoplastic material, such as polypropylene, polystyrene, polyamide, polyethylene, and the like. The cap may be a unitary or one-piece cap.

In one embodiment, the at least one protruding element is shaped as at least one rib or bar on the inner side wall of the cap. At least one rib or rod-like member may be disposed along a longitudinal axis between the distal and proximal ends of the cap.

In this embodiment, the protruding element provides reinforcement to the cap by strengthening the cap on the inner surface. Thus, manufacturability of the drug delivery device is facilitated by the use of a relatively thin cap sidewall. In addition, the cap according to this embodiment can be implemented as a single injection molded part without significant design changes to conventional caps.

According to another embodiment, at least one rib on the inner side wall of the cap can provide a guiding action when attempting to engage the cap with the housing.

The ribs of the cap may be arranged to enter into corresponding grooves on the housing or needle retainer when an attempt is made to engage the cap with the housing. Thus, the ribs provide an orientation configuration that prevents a user from placing the cap in the wrong orientation relative to the housing. Rotation of the cap relative to the housing may be prevented by the mechanical interaction of the ribs and corresponding grooves. It should be understood that it is within the scope of the present invention to provide a plurality of ribs. Additionally, a plurality of ribs on the inner surface of the cap can be implemented to allow the cap to assume a single orientation or multiple orientations relative to the shell.

Another embodiment provides a needle attachment means that allows the needle assembly and the needle holder to be connected by rotation relative to each other.

The needle holder may comprise external threads which are engageable with corresponding internal threads of the needle assembly.

According to another embodiment, the needle connection means comprises a bayonet connection (bayonet connection).

Such needle holder and needle assembly can be easily implemented in a drug delivery device. In addition, the attachment of the needle assembly is simplified since the corresponding threads provide a simple mechanical connection. Due to the threaded connection, the outer diameter of the needle assembly (outer diameter) is significantly larger than the outer diameter of the needle holder. Thus, the one or more protruding elements may be adapted in a radial direction to the space occupied by the needle assembly surrounding the needle holder. Thus, the design of the cap can be adapted to different types of needle assemblies.

In one embodiment, the protruding element is arranged such that it is in contact with the needle assembly in a region between the outer diameter of the needle holder and the outer diameter of the needle assembly.

The actual design of the cap is not dependent on the exact dimensions of the needle assembly as long as the protruding elements are able to contact the needle assembly in the area between the outer diameter of the needle holder and the outer diameter of the needle assembly. Thus, different types of needle assemblies may be used, which may also be adapted to accommodate long needles or short needles.

In one embodiment, the protruding element abuts a front side of the needle assembly towards the distal end of the drug delivery device when the needle assembly is connected with the needle holder.

According to this embodiment, the design of the cap is independent of the outer diameter of the needle holder and the outer diameter of the needle assembly. Thus, a wide variety of different needle assemblies may be used for the drug delivery device. In order to accommodate a long needle cannula, a correspondingly long cap should be used.

When the cap is placed on the housing, the risk of needle stick injuries is reduced by providing a chamber in which the needle is located. When an attempt is made to engage the cap with the housing, the chamber is able to surround the needle assembly without its interior surface abutting the needle cannula of the needle assembly. The chamber may be disposed around the needle assembly without abutting the needle cannula.

In one embodiment, the securing element of the cap is disposed at an end of the cap facing the proximal end of the housing.

In this embodiment, the securing element may be provided in an area of the cap that may be manufactured from a relatively flexible material. This allows engagement of the cap with the housing with only a relatively small force applied by the user. Thus, the operation of the drug delivery device is improved.

According to another embodiment, the fixing elements are engageable with corresponding counterpart fixing elements on the housing.

In this embodiment, the securing element can be manufactured as a pair of counter devices which can be easily implemented, in particular when the cap is provided in the form of a single injection-moulded part. Thus, the manufacture of the drug delivery device is simplified.

According to another embodiment, the fixing element and the corresponding counter-fixing element comprise a snap feature or a clip element (clip) capable of engaging with the corresponding groove.

This allows a simple fixing of the cap to the housing.

According to another embodiment, the cap includes at least one projection disposed on an end face of the cap.

In this embodiment, the cap may be implemented such that the projections enter into corresponding portions of the housing. Thus, the orientation of the cap relative to the housing may be defined by the projection. This prevents rotation of the cap relative to the housing.

According to another embodiment, the cap comprises two projections located at symmetrical positions around a longitudinal axis disposed between the distal end and the proximal end of the cap.

In this embodiment, the number of possible orientations of the cap relative to the housing is reduced, which facilitates engagement of the cap with the housing. In addition, the user is only allowed to place the cap in two possible orientations. Thus, the user is prevented from engaging the cap in an arbitrary position relative to the housing.

According to another embodiment, the housing comprises a cartridge holder capable of enclosing a drug-containing cartridge, wherein the cap is attachable such that the cap covers at least a portion of the cartridge holder.

In this embodiment, the housing comprises a cartridge holder which may be manufactured as a separate component together with the body in which the drive mechanism may be provided. Thus, the manufacture of the drug delivery device is improved.

For the above purpose, a cap is used for covering the distal end of a drug delivery device having a housing with a needle holder adapted for connection of a needle assembly at the distal end of the housing, the cap comprising a fixation element capable of fixing the cap by engagement with the housing, the fixation element not being engaged with the housing when the needle is connected with the needle holder.

Drawings

Other features will become apparent from the following detailed description and the accompanying drawings.

In the drawings:

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

fig. 2 schematically shows a simplified cross-sectional side view of a drug delivery device according to an embodiment;

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

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

fig. 5 schematically shows a cross-sectional view of a part of a drug delivery device according to an embodiment; and

fig. 6 schematically shows a simplified side view of a drug delivery device according to an embodiment.

Detailed Description

Fig. 1 shows an embodiment of a drug delivery device 5, which is a syringe for liquid drugs. The drug delivery device 5 may be arranged to deliver a plurality of fixed drug doses or a plurality of user settable drug doses. The drug delivery device 5 may be a pen-type device. The drug delivery device 5 comprises a housing 10, which may be formed from a single or multiple components.

In the embodiment shown in fig. 1, the housing 10 includes a body 12 and a cartridge holder 14, in which cartridge holder 14 a cartridge 16 containing a pharmaceutical product or drug may be located. The cartridge holder 14 may be fixed against movement relative to the body 12. The needle assembly 20 is located at the distal end 22 of the drug delivery device 5. The needle assembly 20 may be fixed against movement relative to the cartridge holder 14. As will be shown below, the needle assembly 20 may be secured to a needle holder 24, the needle holder 24 being formed as part of the cartridge holder 14 by threaded engagement. The medical product may be injected into a patient through the needle assembly 20.

The delivery of the medical product may be performed by a piston rod or the like (not explicitly shown) which is movable in a distal direction with respect to the cartridge 16. A piston (not explicitly shown) which is held in the cartridge 16 and closes the cartridge 16 on the proximal side can be moved by the piston rod in the distal direction with respect to the cartridge 16. The cartridge holder 14 may be made of a transparent or translucent material, allowing the position of the piston in the cartridge 16 to be viewed.

It should be understood that the description of the drug delivery device 5 shown in fig. 1 is merely exemplary. Other elements may be necessary to achieve full functionality. For example, there may be a dispensing button and a drive mechanism arranged to administer a set dose value and to move the piston in a distal direction to dispense the set amount of medical product when the dispensing button is pressed.

After a particular dose has been administered to a patient, it is often necessary to remove the needle assembly 20 from the drug delivery device 5 in order to prepare the drug delivery device 5 for the next administration. During preparation, a new sterile needle assembly 20 may be connected to needle holder 24. To prevent contamination of the drug delivery device 5, a cap 30 is connected to the drug delivery device 5, said cap 30 covering the distal end of the drug delivery device 5. The cap 30 may be a single injection molded part. The cap 30 includes a fixing member 32, and the fixing member 32 can fix the cap 30 by engaging with the housing 10, i.e., the body 12 or the cartridge holder 14. The cap 30 is securable against axial and rotational movement relative to the housing 10 by a securing element 32.

Referring now to fig. 2, the cap 30 and the distal portion of the drug delivery device 5 are shown in more detail.

In the embodiment shown in fig. 2, the cap 30 includes a protruding element 34 on an inner surface 36 of the cap 30. The projecting element 34 abuts the needle assembly 20 thereby preventing the securing element from engaging the housing. Therefore, since the cap 30 cannot reach its final position with respect to the housing 10, the fixing member 32 of the cap 30 is not engaged with the housing 10. In this embodiment, the projecting element 34 is shaped as an annular step along the inner sidewall of the cap 30. However, other embodiments are also conceivable, comprising a plurality of protruding elements.

As shown in FIG. 2, needle holder 24 includes external threads 26, which external threads 26 are engageable with corresponding internal threads 28 of needle assembly 20. Due to the threaded connection, the outer diameter of the needle assembly 20 is significantly larger than the outer diameter of the needle holder 24. Thus, in the radial direction, the projecting element 34 abuts the needle assembly 20 in the region between the needle assembly 20 and the above-mentioned needle holder 24.

In the embodiment shown in fig. 2, the projecting element 34 is in a position close to the thread of the needle holder 24, in case the needle assembly 20 is not connected to the needle holder 24. When the needle assembly 20 is connected to the housing, the cap 30 encloses a chamber 38 along an inner surface 36 of the cap 30. When attempting to engage the cap 30 on the cartridge holder 14 with the needle assembly 20 connected to the needle holder 24, the chamber 38 can surround the needle assembly 20 without abutting the needle 40 of the needle assembly. Therefore, when an attempt is made to engage the cap 30 with the housing 10, the cap 30 is not pierced.

Referring now to fig. 3, the cap 30 and the distal portion of the drug delivery device 5 are shown in more detail according to another embodiment. As shown in fig. 3, the cap 30 includes a protruding element shaped as a rib 50 on the inner sidewall 36 of the cap 30. Ribs 50 are disposed along a longitudinal axis 52 between distal end 22 and proximal end 54. It should be understood that multiple ribs 50 are also contemplated.

The ribs 50 of the cap 30 may be arranged such that when an attempt is made to engage the cap with the housing (not shown in fig. 3), said ribs 50 enter into corresponding grooves on the housing or the needle holder. Thus, the ribs 50 provide an orientation configuration that prevents a user from placing the cap 30 in a random orientation relative to the housing 10. The mechanical interaction of the ribs 50 and corresponding grooves prevent the cap 30 from rotating relative to the housing 10.

It should be understood that the protruding elements 34 or ribs 50 shown in fig. 2 and 3 are exemplary only. Other embodiments are also within the scope of the present invention, including protruding elements that abut the front side of the needle assembly 20 towards the distal end 22 of the drug delivery device 5 when the needle assembly 20 is connected with the needle holder 24.

Reference is now made to fig. 4, which shows, in a sectional view, a cap 30 according to an embodiment similar to that shown in fig. 2. The cross-sectional view is along the line a-a' shown in fig. 2. In the embodiment shown in fig. 4, the protruding element 34 is shaped as an annular step around the inner sidewall 36 of the cap 30.

Reference is now made to fig. 5, which shows, in a sectional view, a cap 30 according to an embodiment similar to that shown in fig. 3. The cross-sectional view is along the line B-B' shown in fig. 3. In the embodiment shown in fig. 5, the protruding elements are shaped as three ribs 50 disposed along a longitudinal axis 52 between the proximal and distal ends of the cap 30.

In fig. 6, another embodiment of the cap 30 includes two projections 60, the two projections 60 being located at symmetrical positions about the longitudinal axis 52. The projections can enter corresponding recesses on the housing. Thus, the number of possible orientations of the cap 30 relative to the housing is reduced. The securing element may be disposed near the proximal end of the cap 30, particularly on the inner surface of the protrusion 60. The fixing elements are capable of engaging with corresponding counterpart fixing elements on the housing 10. As shown in fig. 6, the mating securing element includes a snap feature 62 or jaw that can engage a corresponding groove on the cap. However, other embodiments are also conceivable, including snap-on features or jaws on the cap 30 and corresponding grooves on the housing.

Other implementations are within the scope of the following claims. Elements of different embodiments may be combined to form embodiments not specifically described herein.

Reference symbols of the drawings

Drug delivery device 5

Housing 10

Main body 12

Cartridge holder 14

Cartridge 16

Needle assembly 20

Distal end 22

Needle retainer 24

External thread 26

Internal thread 28

Cap 30

Fastening element 32

Projecting element 34

Inner surface 36

Chamber 38

Rib 50

Longitudinal axis 52

Proximal end 54

Projections 60

Fastener part 62

Claims (20)

1. A drug delivery device, comprising:

a housing (10), said housing (10) having a needle holder (24) adapted to connect a needle assembly (20) with the housing (10) at a distal end (22); and

a cap (30), the cap (30) being capable of covering the distal end (22) of the drug delivery device (5) and comprising a fixation element (32) capable of fixing the cap (30) by engagement with the housing (10), the fixation element (32) being prevented from engaging with the housing (10) when the needle assembly (20) is connected with the needle holder (24).

2. The drug delivery device of claim 1, wherein the cap (30) comprises at least one protruding element (34) on an inner surface, the protruding element (34) abutting the needle assembly, thereby preventing the securing element (32) from engaging the housing (10).

3. The drug delivery device of claim 2, wherein the at least one protruding element (34) is shaped as a step along an inner side wall (36) of the cap (30).

4. The drug delivery device of claim 2, wherein the at least one protruding element (34) is shaped as at least one rib (50) on an inner sidewall (36) of the cap (30), the at least one rib (50) being disposed along a longitudinal axis (52) disposed between the distal end (22) and the proximal end (54).

5. The drug delivery device of claim 4, wherein the at least one rib (50) on the inner side wall (36) of the cap (30) is capable of providing a guiding action when attempting to engage the cap (30) with the housing.

6. The drug delivery device according to any of claims 1 to 5, wherein a needle connection means is provided which allows the needle assembly (20) and the needle holder (24) to be connected by rotation relative to each other.

7. The drug delivery device of claim 6, wherein the needle holder (24) comprises an external thread (28), the external thread (28) being engageable with a corresponding internal thread (26) of the needle assembly (20).

8. A drug delivery device according to claim 6 or 7, wherein the needle connection means comprises a bayonet connection.

9. The drug delivery device of any of claims 1 to 8, wherein the protruding element (34) is arranged to contact the needle assembly (20) in a region between an outer diameter of the needle holder (24) and an outer diameter of the needle assembly (20).

10. The drug delivery device according to any of claims 1 to 9, wherein the protruding element (34) abuts a front side of the needle assembly (20) towards the distal end (22) of the drug delivery device when the needle assembly (20) is connected with the needle holder (24).

11. The drug delivery device of any of claims 1 to 10, wherein the cap (30) encloses a chamber (38) along an inner surface (36) of the cap (30).

12. The drug delivery device of claim 11, wherein the chamber (38) is capable of surrounding the needle assembly (24) without abutting the needle (40) of the needle assembly (20) when attempting to engage the cap (30) with a housing having the needle assembly connected to the needle holder (24).

13. The drug delivery device of claim 12, wherein the securing element (32) is arranged at an end of the cap (30) facing the proximal end of the housing.

14. The drug delivery device of claim 12 or 13, wherein the securing element (32) is engageable with a corresponding counterpart securing element on the housing.

15. The drug delivery device of claim 14, wherein the securing element (32) and the corresponding counter-securing element (62) comprise snap-in parts which are engageable with the corresponding grooves (62).

16. The drug delivery device of any of claims 1 to 15, wherein the cap (30) comprises at least one protrusion (60) provided on an end face of the cap (30).

17. The drug delivery device of claim 16, wherein the cap (30) comprises two projections (60), the two projections (60) being located at symmetrical positions around a longitudinal axis (54), the longitudinal axis (54) being disposed between the distal end and the proximal end.

18. The drug delivery device of any of claims 1 to 17, wherein the housing comprises a cartridge holder (14) adapted to enclose a drug-containing cartridge (16), wherein a cap (30) is attachable such that the cap (30) covers at least a portion of the cartridge holder.

19. The drug delivery device of any of claims 1 to 18, wherein the cap (30) is a single injection molded part.

20. Use of a cap for covering a distal end of a drug delivery device having a housing with a needle holder adapted for connection of a needle assembly at the distal end of the housing, the cap (30) comprising a fixation element capable of fixing the cap (30) by engagement with the housing, the fixation element being prevented from engaging with the housing when the needle is connected with the needle holder.