AN INJECTION DEVICE WITH AN IMMOBILIZATION MECHANISM

Abstract

The invention relates to an injection device for injecting doses of a liquid drug, which comprises an immobilization mechanism such that the further use of the injection device is immobilized in response to the needle cannula (20) being exposed to an axial force above a predetermined value: the immobilization mechanism comprises a flexible arm (50) which apply a radial force onto the needle cannula at least during injection.

Claims

1. An injection device for injecting doses of a liquid drug, comprising: a housing structure holding a container containing the liquid drug to be injected, a needle cannula connected to the housing structure and having a distal end with a distal tip for penetrating the skin (S) of a user and a proximal end for connecting to the container and a lumen there between, a movable needle shield movable relatively to the housing structure between a first position and a second position; the first position being a position in which the needle shield covers at least the distal tip of the needle cannula, the second position being a position in which the needle shield is retracted such that the distal tip of the needle cannula is exposed, and wherein the injection device further comprises an immobilization mechanism which immobilizes the injection device in response to the needle cannula being exposed to an axial force above a predetermined value and which immobilization mechanism comprises a flexible arm which apply a radial force onto the needle cannula.

2. An injection device according to claim 1, wherein the predetermined value is the axial force needed to bend the needle cannula.

3. An injection device according to claim 1, wherein the flexible arm is movable from a first radial position to a second radial position in response to bending of the needle cannula.

4. An injection device according to claim 3, wherein the flexible arm when in the second radial position prevents axial movement of the needle shield.

5. An injection device according to claim 3, wherein the flexible arm is provided with a distally pointing end surface which engages the needle shield when the flexible arm is in the second radial position.

6. An injection device according to claim 1, wherein the flexible arm is connected to a needle hub securing the needle cannula.

7. An injection device according to claim 1, wherein a radial force urges the flexible arm radially against the needle cannula.

8. An injection device according to claim 1, wherein the flexible arm is provided with an outwardly pointing protrusion.

9. An injection device according to claim 1, wherein the needle shield is rotatable relatively to the housing structure from a locked to an unlocked position.

10. An injection device according to claim 9, wherein the protrusion abuts the needle shield when the needle shield is rotated to the unlocked position.

11. An injection device according to claim 1, wherein the needle shield is provided with a raised locking area on an inner surface thereof.

12. An injection device according to claim 11, wherein the abutment of the raised locking area with the protrusion generates the radial force urging the flexible arm radially against the needle cannula.

13. An injection device according to claim 11, wherein the raised locking area is provided with at least one sloped surface.

14. An injection device according to claim 1, wherein the flexible arm has a radial extension abutting the needle cannula.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0049] The invention will be explained more fully below in connection with a preferred embodiment and with reference to the drawings in which:

[0050] FIG. 1 show a cross-sectional view of the front end of the injection device with the needle shield in the locked mode.

[0051] FIG. 2 show a cross-sectional view of the front end of the injection device with the needle shield in the un-locked mode.

[0052] FIG. 3 show a cross-sectional view of the front end of the injection device during injection.

[0053] FIG. 4 show a cross-sectional view of the front end of the injection device with the needle cannula bended.

[0054] FIG. 5 show a perspective view of the needle hub and the flexible arm.

[0055] FIG. 6 show a perspective view of the needle hub and an example of a flexible arm dismounted from the needle hub.

[0056] FIG. 7 show a perspective view of the needle hub and an example of a flexible arm mounted on the needle hub.

[0057] The figures are schematic and simplified for clarity, and they just show details, which are essential to the understanding of the invention, while other details are left out. Throughout, the same reference numerals are used for identical or corresponding parts.

DETAILED DESCRIPTION OF EMBODIMENT

[0058] When in the following terms as “upper” and “lower”, “right” and “left”, “horizontal” and “vertical”, “clockwise” and “counter clockwise” or similar relative expressions are used, these only refer to the appended figures and not to an actual situation of use. The shown figures are schematic representations for which reason the configuration of the different structures as well as there relative dimensions are intended to serve illustrative purposes only.

[0059] In that context it may be convenient to define that the term “distal end” in the appended figures is meant to refer to the end of the injection device carrying the needle cannula and the tip of the needle cannula doing the actual penetration of the skin of a user, whereas the term “proximal end” is meant to refer to the opposite end. Distal and proximal is meant to be along an axial orientation extending along the central axis (X) of the injection device as also disclosed in FIG. 3.

[0060] The FIGS. 1 to 4 disclose the front part of the injection device. The dose setting and injection mechanism often referred to as the dose engine is not shown in the figures but could in one example be a torsion spring dose engine as disclosed in WO 2019/002020.

[0061] FIG. 1, FIG. 2 and FIG. 3 all disclose the injection device during ordinary use. In FIG. 1 the needle shield 40 is locked in the initial first position. In FIG. 2 the needle shield is still in the first position but has been rotated to the unlocked NPR position and in FIG. 3 the needle shield (40) is pushed in proximal direction into the second position and an injection is being performed.

[0062] The liquid drug to be injected is contained in a cartridge 10 which is secured in a housing structure 1. The liquid drug preferably contains a preservative and a volume of the preservative containing liquid drug is also present in a cleaning chamber 46 to clean the distal tip 21 of the needle cannula 20 between injections as will be explained.

[0063] The housing structure 1 can be made from several components which a connected to form one housing or alternative the housing structure 1 can be moulded as one unitary part. Usually such housing structure 1 comprises a cartridge holder part which secures the cartridge 10.

[0064] During initiation of the injection device a volume of the preservative containing drug which operates as the cleaning agent is pumped from the cartridge 10 and into the cleaning chamber 46 through the lumen 23 of the needle cannula 20. The needle cannula 20 further has a distal end with a distal tip 21 for penetrating the skin (S) of the user during injection and a proximal end 22 which is inserted into the cartridge 10.

[0065] The cartridge 10 is sealed at the distal end by a pierceable septum 11 whereas the proximal end of the cartridge 10 is provided with a non-shown plunger which can be moved in the distal direction by the dose engine to thereby pressurize the cartridge 10 such that a quantum of the preservative containing liquid drug inside the cartridge 10 is pressed through the lumen 23 of the needle cannula 20 and into the body of the user.

[0066] The needle cannula 20 is secured in a needle hub 30 which in the initiated state is clicked onto the housing structure 1 by a click-arm 31 which engages the housing structure 1. The needle cannula 20 is preferably glued to the needle hub 30 but could be secured in alternative ways.

[0067] Further, a needle shield 40 is provided which needle shield 40 is able to slide telescopically after being unlocked. As explained in WO 2017/032599, the needle shield 40 is prevented form axial movement in the initial state (FIG. 1) but can be unlocked by a rotation of the needle shield 40 into the NPR state. In the NPR state which is disclosed in FIG. 2 the needle shield 40 is able to slide axially in the proximal direction and an injection can be performed.

[0068] The injection is preferably done by the user pressing the distal end of the needle shield 40 against the skin “S” as indicated in FIG. 3. The axial movement of the needle shield 40 triggers the dose engine to release the torque in the torsion spring which thus moves the piston rod and the plunger inside the cartridge 10 forward to thereby pressurize the cartridge 10.

[0069] Distally the needle shield 40 carries a cleaning assembly 45 which comprises a cleaning chamber 46. The cleaning chamber 46 contains an amount of the same liquid drug as present in the cartridge 10 and is distally sealed by a pierceable septum 47. Proximally, the cleaning chamber 46 is closed by a movable plunger 48 which is able to move proximally as the cleaning chamber 46 is being filled with preservative containing liquid drug from the cartridge 10.

[0070] The cleaning chamber 46 also, in one example, comprises a narrow channel 49. Should the needle cannula 20 be accidentally bended during use then the needle cannula 20 will be straightened when the cleaning assembly 45 is moved distally after the injection has been performed. It is in that respect important that the channel 49 is narrow to fit the outer diameter of the needle cannula 20. However, the channel 49 can have a larger diameter if not functioning as a straightener. The movable plunger 48 which comprises a soft distal part doing the actually sealing of the cleaning chamber 46 and a more hard proximal part which is also provided with a narrow channel to assist in straightened the needle cannula 20 if bended.

[0071] Further, a needle cannula 20 which is especially suitable for use in the described cleaning assembly 45 is the needle cannula 20 described in International patent application No.: PCT/EP2019/061830 filed by Novo Nordisk NS, which is hereby included by reference. Especially, the grind on this needle cannula 20 hinders that the distal tip 21 of the needle cannula slices of fragments from the walls of the narrow channel 49 both during manufacturing of the injection device and in later use of the injection device. The distal tip 21 of the needle cannula 20 can further be glass blasted or electro polished to further prevent fragmentation of the walls of the channel 49.

[0072] The cleaning assembly 45 is both rotational and axial connected to the needle shield 40 such that the cleaning assembly 45 follow both axial and rotational movement of the needle shield 40.

[0073] In the NPR state disclosed in FIG. 2 the needle shield 40 has been rotated helically in the proximal direction such that the distal tip 21 of the needle cannula 20 is positioned outside the cleaning chamber 46. When the distal tip 21 of the needle cannula 20 is positioned outside the cleaning chamber 46, the pressure in the lumen 23 of the needle cannula 20 and inside the cartridge 10 can equalized with the atmospheric pressure surrounding the liquid system. The NPR state henceforth has the purpose of venting the liquid system before performing an injection. If a pressure is allowed in the interior of the cartridge 10 when the needle cannula 20 is inserted into the skin (S) of the user, such overpressure would pump out liquid drug and a wrongful amount of liquid drug would be injected. It is thus important to vent the liquid system prior to performing an injection. As seen in FIG. 2, the distal tip 21 of the needle cannula 20 is maintained protected by the needle shield 40 in this NPR position.

[0074] Connected to the hub 30 is a flexible arm 50 which has an inwardly protruding extension 51 which points towards the needle cannula 20 as depicted in FIG. 1. On the outer surface of the flexible arm 50, opposite the inwardly protruding extension 51, an outwardly pointing protrusion 52 is provided. Further, the flexible arm 50 has a distally pointing end surface 53.

[0075] In the initial state disclosed in FIG. 1, the flexible arm 50 is at rest and no radial force is applied onto the needle cannula 20.

[0076] The needle shield 40 is further provided with a raised locking area 41 on the inner surface. This raised locking area 41 is shaped as lump or protrusion and is provided with a sloped surface 42 pointing in the proximal direction when seen from the highest point.

[0077] When the user rotate the needle shield 40 from the initiated state of FIG. 1 and into the NPR state of FIG. 2, this raised locking area 41 follows the helical movement of the needle shield 40 and is thus moved helically. During this helical movement the sloped surface 42 engages with the outwardly pointing protrusion 52 on the flexible arm 50 and pushes the outwardly pointing protrusion 52 inwardly towards the centre line (X) as best seen in FIG. 2.

[0078] This engagement provides a radial force on the flexible arm 50 which thus bends inwardly and applies a radial force on the needle cannula 20. The radial force on the needle cannula (20) is preferably made by the inwardly protruding extension 51 and is indicated with the arrow (F) in FIG. 2. In this position, the end surface 53 of the flexible arm 50 is forced outwardly as best seen in FIG. 2 thus allowing the needle shield 40 to move axially.

[0079] During injection, the user pushes the needle shield 40 against the skin (S) as previously explained and further indicated in FIG. 3. The axial movement of the needle shield 40 activates the injection device to expel the set dose through the lumen 23 of the needle cannula 20.

[0080] During injection as disclosed in FIG. 3, the needle shield 40 is moved proximally and the raised locking area 41 follow this axial movement and thus releases the radial force on the protrusion 52 on the flexible arm 50. The result being that no radial force is applied onto the needle cannula 20 during injection. When the proper amount of preservative containing liquid drug has been injected into the body of the user, the user removes the distal end of the needle shield 40 from the skin and a non-shown spring automatically moves the needle shield 40 distally into the NPR position disclosed in FIG. 2.

[0081] In the NPR state of FIG. 2, the needle shield 40 is unlocked and free to move in the proximal direction. If the user, when the injection device is in the NPR state, accidentally drops the injection device onto a hard surface this could potentially damage the needle cannula 20. The distal tip 21 of the needle cannula 20 would thus together with the distal end of the needle shield 40 be forced in the proximal direction by the impact with the hard surface. This would course the needle cannula 20 to bend if the force of the impact is above the force usually required to bend the needle cannula. Such bending of the needle cannula 20 could potential obstruct the passage through the lumen 2. It is henceforth desired to somehow inform the user that the needle cannula 20 is inoperable.

[0082] The flexible arm 50 urging a radial force onto the needle cannula 20 will whenever the needle cannula 20 is bended encourage and amplify the needle cannula 20 to bend in a controlled manner in the radial direction following the radial force F applied onto the needle cannula 20. This is indicated by the arrow B in FIG. 4.

[0083] When the needle cannula 20 accidentally impacts the hard surface and starts to bend, the flexible arm 50 will not only amplify the bending but will also move further in the radial direction as disclosed in FIG. 4 such that the distal end 53 of the flexible arm 50 moves radially into a position in which the flexible arm 50 prevents axial movement of the cleaning assembly 45 and thus of the needle shield 40.

[0084] When the force applied onto the needle cannula 20 by the flexible arm 50 amplifies the bending of the needle cannula 20, the distal tip 21 also move in the proximal direction as the proximal end 22 of the needle cannula is anchored in the needle hub 30 and is unable to move. The distal tip 21 of the needle cannula 20 is thus moved into the needle shield 40 and cannot be used if the user should try to perform a new injection. At the same time the distal end 53 of the flexible arm 50 prevents the needle shield 40 from moving in the proximal direction. It is thus not possible for the user to perform an injection if the needle cannula 20 has been damaged.

[0085] FIG. 5 discloses the flexible arm 50 attached to the needle hub 30. The flexible arm 50 can either be an integral part of the needle hub 30 or it can be a separate part connected to the needle hub 30. The proximal part of the flexible arm 50 is in one example be provided with a knob 54 engaging the housing structure 1 such that proximal end of the flexible arm 50 is secured between the housing structure 1 and the needle hub 30. In one example the flexible arm 50 is moulded from a suitable polymer.

[0086] Further, the needle hub 30 is preferably provided with an opening 32 through which opening 32 the flexible arm 50 operates when it is flexed radially.

[0087] A slightly different example of a flexible arm 50 is disclosed in FIG. 6 and in FIG. 7. Since the working principle of this second example is as in the first example; similar parts have been numbered with the same numbering.

[0088] The flexible arm 50 herein disclosed is formed from a metallic tape which proximally has two radial bands 55 which can be clicked onto the needle hub 30 such that the radial extension 51 extend through the opening 32 in the needle hub 30 as best seen in FIG. 7.

[0089] Some preferred embodiments have been shown in the foregoing, but it should be stressed that the invention is not limited to these, but may be embodied in other ways within the subject matter defined in the following claims.