Injection device with needle hiding element

Abstract

The injection device includes a needle, a needle sleeve surrounding the needle, the needle sleeve having an aperture and positioned so that the needle extends through the aperture during an injection process, and a needle hiding element movable relative to the needle sleeve between a first position and a second position. The needle hiding element is coupled to the needle sleeve when in the first position and when in the second position. The needle hiding element is positioned to cover a larger portion of the aperture when in the second position than when in the first position.

Description

[Technical field]

[0001] The present invention relates to an injection device having a needle hiding element for hiding the needle. [Background technology]

[0002] Injection devices, such as auto-injectors, that dispense medication to an injection site on a patient are known in the art. Such injection devices often include a body and a cap, with a needle syringe located within the body, and the cap removably attached to the body to shield the needle of the needle syringe. To dispense the medication, the cap is first removed from the body to expose the needle. The needle is then inserted into the patient's body at the injection site to dispense the medication.

[0003] Some patients may experience anxiety about the injection process. For example, some patients may have a fear of needles and may find the injection process unpleasant. There is a desire to reduce patient anxiety surrounding the injection process. Summary of the Invention [Problem to be solved by the invention]

[0004] It is an object of the present invention to provide an injection device having a needle hiding element. [Means for solving the problem]

[0005] According to the invention there is provided an injection device comprising: a needle; a needle sleeve surrounding the needle, the needle sleeve having an aperture and arranged such that the needle extends through the aperture during the injection process; and a needle hiding element movable between a first position and a second position relative to the needle sleeve, the needle hiding element being connected to the needle sleeve when in the first position and when in the second position and arranged such that the needle hiding element covers a larger portion of the aperture when in the second position than when in the first position.

[0006] The needle hiding element may be biased towards the second position, which may ensure that the needle is automatically hidden by default, reducing patient anxiety.

[0007] The needle hiding element can be arranged to move from a first position to a second position in response to the cap being removed from the needle sleeve of the injection device, thereby providing a simple mechanism for ensuring that the needle remains hidden prior to an injection.

[0008] The injection device may further include a housing, the needle being fixed relative to the housing and the needle sleeve being configured to move within the housing, which may provide a simple mechanism for exposing the needle through an aperture in the needle sleeve during injection.

[0009] The injection device may further include a housing, the needle sleeve being fixed relative to the housing and the needle being configured to move relative to the housing sleeve, which may provide a simple mechanism for exposing the needle through an aperture in the needle sleeve during injection.

[0010] The needle hiding element can include at least one flap disposed within the needle sleeve, the at least one flap pivotally coupled to the needle sleeve such that the at least one flap can pivot between a first position and a second position, thereby providing an embodiment of the needle hiding element that is simple to manufacture and easy to operate.

[0011] At least one flap can be configured to pivot between a first position and a second position about an axis of rotation substantially parallel to the aperture, which can provide a compact implementation of the needle hiding element.

[0012] The at least one flap can be connected to the needle sleeve by a living hinge, and the at least one flap can be biased toward the second position by the living hinge, thereby providing a simple implementation of the needle hiding element with a minimum of parts.

[0013] The needle hiding element may include an iris diaphragm or a resilient diaphragm. The use of an iris diaphragm or a resilient diaphragm may provide a compact and simple implementation of the needle hiding element.

[0014] The needle hiding element can be arranged to have an opening when in the second position, and the needle can extend through the opening during the injection process, thereby allowing the needle hiding element to remain in place before, during, and after the injection process, reducing patient anxiety.

[0015] The hiding element can be integrally formed with the needle sleeve, which provides a simple implementation of the needle hiding element that is simple to manufacture, for example the needle hiding element and the needle sleeve can be integrally formed using an injection molding process.

[0016] The needle hiding element can be configured to lock in the second position in response to moving from the first position to the second position, which can improve safety of the injection device by limiting access to the needle inside the needle sleeve, which can also reduce patient anxiety by ensuring that the needle hiding element remains in the second position, hiding the needle.

[0017] The injection device may further include a cap having a needle shield, the needle shield being at least partially located within the needle sleeve, and the needle hiding element being held in the first position by the needle shield when the needle shield is at least partially located within the needle sleeve, which may provide a simple way of enabling the needle hiding element to move from the first position to the second position.

[0018] The injection device can be an auto-injector, a pen injector, a safety syringe, or a large volume injection device.

[0019] The injection device may further include a container for containing the medicament.

[0020] The needle hiding element can reduce the visibility of the needle to the user, thereby reducing patient anxiety. The needle hiding element can also improve the safety of the injection device by limiting the user's access to the needle. The needle hiding element can also maintain the sterility of the injection device by helping to prevent the ingress of foreign matter, such as dirt, into the needle shield and in the immediate vicinity of the needle.

[0021] Embodiments of the present invention will now be described, by way of example only, with reference to the accompanying drawings, in which: [Brief description of the drawings]

[0022] [Figure 1A] 1 is a schematic side view of an injection device and removable cap embodying the present invention; [Figure 1B] FIG. 1B is a schematic side view of the injection device of FIG. 1A with the cap removed from the housing. [Diagram 2] FIG. 2 is an enlarged cross-sectional side view of a distal end of an injection device according to an embodiment of the present invention, with a needle hiding element in a first position. [Diagram 3] 3 is an enlarged cross-sectional side view of the distal end of the injection device of FIG. 2, with the needle hiding element in a second position. FIG. [Figure 4]FIG. 3 is an enlarged three-dimensional view of the distal end of the injection device of FIG. 2. [Diagram 5] FIG. 4 is an enlarged three-dimensional view of the distal end of the injection device of FIG. [Figure 6] FIG. 5 is a three-dimensional partial view of the flap shown in FIG. 4 connected to a needle sleeve. [Figure 7] FIG. 3 is a view of the injection device of FIG. 2, taken along the longitudinal axis of the injection device from the distal end towards the proximal end. [Figure 8] FIG. 4 is a view of the injection device of FIG. 3, taken along the longitudinal axis of the injection device from the distal end towards the proximal end. [Figure 9] 1 is an enlarged cross-sectional side view of a distal end of an injection device according to another embodiment of the present invention, with a needle hiding element in a first position. [Figure 10] 10 is an enlarged cross-sectional side view of the distal end of the injection device of FIG. 9, with the needle hiding element in a second position. [Figure 11] FIG. 10 is a view of the injection device of FIG. 9, taken along the longitudinal axis of the injection device from the distal end towards the proximal end. [Figure 12] FIG. 11 is a view of the injection device of FIG. 10, taken along the longitudinal axis of the injection device from the distal end towards the proximal end. [Figure 13] FIG. 13 is an enlarged cross-sectional side view of a distal end of an injection device according to yet another embodiment of the invention, with a needle hiding element in a first position. [Figure 14] 14 is an enlarged cross-sectional side view of the distal end of the injection device of FIG. 13, with the needle hiding element in a second position. FIG. [Figure 15] FIG. 14 is a view of the injection device of FIG. 13, taken along the longitudinal axis of the injection device from the distal end towards the proximal end. [Figure 16] FIG. 15 is a view of the injection device of FIG. 14, taken along the longitudinal axis of the injection device from the distal end towards the proximal end. [Figure 17] FIG. 13 is an enlarged cross-sectional side view of a distal end of an injection device according to yet another embodiment of the invention, with a needle hiding element in a first position. [Figure 18]18 is an enlarged cross-sectional side view of the distal end of the injection device of FIG. 17, with the needle hiding element in a second position. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0023] Drug delivery devices as described herein can be configured to inject a patient with a medication. For example, delivery can be subcutaneous, intramuscular, or intravenous. Such devices can be operated by the patient or a caregiver, such as a nurse or doctor, and can include various types of safety syringes, pen injectors, or auto-injectors. The devices may include cartridge-based systems in which a sealed ampoule must be pierced prior to use. The volume of medication delivered with these various devices can range from about 0.5 ml to about 3 ml. Another device may include a large volume device ("LVD") or patch pump configured to adhere to the patient's skin for a period of time (e.g., about 5, 15, 30, 60, or 120 minutes) to deliver a "large" amount of medication (typically about 2 ml to about 10 ml). Yet another device may include a pre-filled syringe within the housing of the device. The syringe may be fixed within the housing or may be movable within the housing, for example, from a retracted position to an operational extended position.

[0024] The devices described herein can also be customized to work within the required specifications in combination with a particular drug. For example, the device can be customized to inject the drug within a certain time period (e.g., about 3 seconds to about 20 seconds for an auto-injector, about 10 minutes to about 60 minutes for an LVD). Other specifications can include shelf life, expiration date, biocompatibility, environmental considerations, etc., versus low or minimal levels of discomfort, or some conditions related to human factors. Such differences can be due to a variety of factors, such as, for example, drugs with viscosities ranging from about 3 cP to about 50 cP. As a result, drug delivery devices often include hollow needles ranging in size from about 25 to about 31 gauge. Common sizes are 17 and 29 gauge.

[0025] The delivery device described herein may also include one or more automated features. For example, one or more of the following may be automated: coupling of the needle to the cartridge, needle insertion, drug injection, and needle retraction. Energy for one or more automated steps may be provided by one or more energy sources. The energy sources may include, for example, mechanical energy, pneumatic energy, chemical energy, or electrical energy. For example, the mechanical energy sources may include springs, levers, elastomers, or other mechanical mechanisms that store or release energy. One or more energy sources may be combined into a single device. The device may further include gears, valves, or other mechanisms that convert energy into the movement of one or more components of the device.

[0026] One or more automated features of the auto-injector can each be activated via an activation mechanism. Such an activation mechanism can include one or more of an actuator, such as a button, a lever, a needle sleeve, or other activation components. Activation of an automated feature can be a one-step or multi-step process. That is, a user may need to activate one or more activation components to trigger an automated feature. For example, in a one-step process, a user may press a needle sleeve against their body to trigger an injection of a medication. Other devices may require multi-step activation of an automated feature. For example, a user may need to depress a button and retract a needle shield to trigger an injection.

[0027] Additionally, activation of one automated function may activate one or more subsequent automated functions, thereby forming an activation sequence. For example, activation of a first automated function may activate at least two of: coupling the needle to the cartridge, inserting the needle, injecting the medication, and retracting the needle. Some devices may require a particular sequence of steps for one or more automated functions to occur. Other devices may operate with a sequence of independent steps.

[0028] Some delivery devices can include one or more features of a safety syringe, a pen injector, or an auto-injector. For example, a delivery device can include a mechanical energy source configured to automatically inject a medication (as typically found in an auto-injector) and a dose setting mechanism (as typically found in a pen injector).

[0029] 1A and 1B show an exemplary drug delivery device 10, also known as an injection device, in accordance with some embodiments of the present disclosure. The device 10 is configured to inject a medication into a patient's body, as described above. The device 10 typically includes a housing 11 that houses a cartridge or pre-filled syringe that defines a reservoir that contains the medication to be injected, and components necessary to facilitate one or more steps of the delivery process.

[0030] The device 10 may also include a cap 12 that may be removably attached to the housing 11. Typically, a user must remove the cap 12 from the housing 11 before the device 10 can be operated.

[0031] As shown, the housing 11 is substantially cylindrical and has a substantially constant diameter along a longitudinal axis AA. The housing 11 has a distal region D and a proximal region P. The term "distal" refers to a location relatively closer to the injection site and the term "proximal" refers to a location relatively further from the injection site.

[0032] The device 10 can also include a needle sleeve 19 coupled to the housing 11 to allow movement of the sleeve 19 relative to the housing 11. For example, the sleeve 19 can move in a longitudinal direction parallel to the longitudinal axis AA. Specifically, movement of the sleeve 19 in a proximal direction can cause the needle 17 to extend from a distal region D of the housing 11.

[0033] Insertion of needle 17 can occur via a number of mechanisms. For example, needle 17 can be fixedly positioned relative to housing 11 and initially positioned within an extended needle sleeve 19. The distal end of sleeve 19 is placed against the patient's body and housing 11 is moved distally, exposing the distal end of needle 17 by moving sleeve 19 proximally. This relative movement allows the distal end of needle 17 to extend into the patient's body. This insertion is referred to as a "manual" insertion because needle 17 is manually inserted via the patient manually moving housing 11 relative to sleeve 19.

[0034] Another form of insertion is "automated," whereby needle 17 moves relative to housing 11. Such insertion can be triggered by movement of sleeve 19 or by another form of activation, such as, for example, button 13. As shown in FIGS. 1A and 1B, button 13 is located at the proximal end of housing 11. However, in other embodiments, button 13 can be located on the side of housing 11.

[0035] Other manual or automated functions can include drug injection or needle retraction, or both. Injection is a process in which the bung or piston 14 is moved from a proximal location to a more distal location within the reservoir of the drug container 18 to force the drug from the container 18 through the needle 17. In some embodiments, before the device 10 is activated, a drive spring (not shown) is in a compressed state. A proximal end of the drive spring can be secured within the proximal region P of the housing 11, and a distal end of the drive spring can be configured to apply a compressive force to a proximal surface of the piston 14. Following activation, at least a portion of the energy stored in the drive spring can be applied to the proximal surface of the piston 14. This compressive force can act on the piston 14 to move it in a distal direction. Such distal movement acts to compress the liquid drug within the container 18 and force it out of the needle 17.

[0036] Following injection, needle 17 may be retracted into sleeve 19 or housing 11. Retraction may occur when sleeve 19 moves distally as the user removes device 10 from the patient's body. This may occur because needle 17 remains in a fixed position relative to housing 11. Once the distal end of sleeve 19 moves past the distal end of needle 17 and needle 17 is covered, sleeve 19 may be locked. Such locking may include locking any proximal movement of sleeve 19 relative to housing 11.

[0037] Another form of needle retraction can occur when the needle 17 is moved relative to the housing 11. Such movement can occur when the cartridge 18 within the housing 11 is moved proximally relative to the housing 11. This proximal movement can be accomplished by using a retraction spring (not shown) located in the distal region D. The compressed retraction spring, when activated, can provide sufficient force to the cartridge 18 to move it proximally. After sufficient retraction, any relative movement between the needle 17 and the housing 11 can be locked with a locking mechanism. Additionally, the button 13 or other components of the device 10 can be locked as desired.

[0038] Referring now to Figure 2, there is shown a portion of an injection device 20 according to an example embodiment of the present invention. The injection device 20 is in the form of an automatic injector having similar features to the device 10 described above in relation to Figures 1A and 1B, and similar features retain the same reference numerals. However, it will be appreciated that the present invention may be applied to other types of injection devices 20.

[0039] A drug container 18 is provided within the housing 11 of the injection device 20. The container 18 contains a liquid drug that is sealed by a piston 14 located within a reservoir of the container 18. The container 18 can be, for example, a cartridge or a syringe. In an initial state, the piston 14 is located closest to a proximal end P of the housing 11. A drive mechanism is provided at the proximal end P of the housing 11 and is arranged to push the piston 14 towards a distal end D of the housing 11 when activated and actuated. A hollow injection needle 17 is coupled to the container 18 so as to be in fluid communication with the reservoir of the container 18. The needle 17 may not initially be in fluid communication with the reservoir of the container 18, but can instead be moved to be in fluid communication. For example, the needle 17 can be actuated to pierce a septum of the container 18. When the needle 17 is in fluid communication with the reservoir of the container 18 , movement of the piston 14 towards the distal end D of the housing 11 displaces the medicament through the needle 17 .

[0040] A cylindrical needle sleeve 19 extends from the distal end D of the housing 11 in a direction parallel to the longitudinal axis of the injection device 20. The needle sleeve 19 circumferentially surrounds the needle 17 and has at its distal end an aperture 21 formed by an inner surface 19a of the needle sleeve 19. The needle 17 protrudes through the aperture 21 during the injection process.

[0041] Before an injection is made, in an initial state, the needle sleeve 19 extends along the longitudinal axis of the injection device 20 beyond the tip of the needle 17, thereby shielding the needle 17. The needle sleeve 19 shields the exposed end of the needle 17, thus preventing unintentional damage during handling of the needle 17, as well as preventing user access to the needle 17 to avoid stick injuries.

[0042] During an injection state, however, the tip of the needle 17 extends beyond the needle sleeve 19 so that the needle 17 can be inserted into the patient. This is accomplished by allowing the needle sleeve 19 to move relative to the needle 17 in a direction parallel to the longitudinal axis. In some examples, the needle 17 remains in a constant longitudinal position relative to the housing 11 while the needle sleeve 19 can move relative to the housing 11 along the longitudinal axis AA. Prior to an injection, the needle sleeve 19 extends beyond the tip of the needle 17. To perform an injection, the needle sleeve 19 is moved proximally along the longitudinal axis AA relative to the housing 11. For example, the needle sleeve 19 can be translated into the housing 11. The movement of the needle sleeve 19 relative to the housing 11 can be in response to a user placing a distal end of the needle sleeve 19 at an injection site and applying a force in a distal direction, thereby moving the housing 11 and the needle 17 towards the injection site while the needle sleeve 19 translates into the housing 11.

[0043] In another example, needle 17 is movable relative to housing 11 and needle sleeve 19 along longitudinal axis AA, while needle sleeve 19 is fixed relative to housing 11. Prior to an injection, needle sleeve 19 extends beyond the tip of needle 17. To perform an injection, needle 17 is moved distally along longitudinal axis AA relative to needle sleeve 19 and housing 11 such that at least the tip of needle 17 protrudes beyond needle sleeve 19.

[0044] A removable cap 12 is coupled to the distal end of the injection device 20. The cap 12 is inserted into the needle sleeve 19 through an aperture 21. The cap 12, like the needle sleeve 19, prevents unintentional damage to the needle 17 during handling of the injection device 20 and can prevent user access to the needle 17 to avoid stick injuries.

[0045] The removable cap 12 may include a needle shield 25. The needle shield 25 has a recess 26 configured to receive a portion 18A of the container 18 housed in the housing 11 of the injection device 20. Friction between the needle shield 25 and the end 18A of the container 18 is sufficient to hold the needle shield 25 and the cap 12 in place over the needle 17. Alternatively or in addition, the cap 12 may be coupled to one or more other members of the injection device 20, such as the needle sleeve 19 or the housing 11. Furthermore, the cap 12 may be coupled to the injection device 20 by a friction fit, by engagement features such as cooperating ridges, grooves, pips or protrusions on the cap 12 and the injection device 20, by adhesive, or by another suitable coupling means.

[0046] The needle shield 25 provides additional protection to the needle 17 by further shielding the needle 17, for example to prevent physical damage to the needle 17 during handling of the injection device 20 or to maintain the sterility of the needle 17.

[0047] Before an injection is made, the cap 12 is removed from the injection device 20 by pulling it in direction F along the longitudinal axis of the injection device 20, thereby removing the needle shield 25 from around the needle 17 and exposing the needle 17 inside the needle sleeve 19. The needle 17 may then be visible to a user when looking inside the needle sleeve 19 through the aperture 21.

[0048] FIG. 2 shows that the injection device 20 also has a needle hiding element 30. The needle hiding element 30 is configured to hide (i.e., make invisible or invisible) the needle 17 from the user. When we say hiding the needle 17, we mean making the needle less visible to the user or making the needle 17 less visible to the user. Hiding the needle 17 does not necessarily mean that the needle 17 is completely invisible to the user, although that may be the case. The needle hiding element 30 makes the needle 17 less visible to the user than it would be if the needle hiding element 30 were not present. In particular, the needle hiding element 30 obscures the visibility of the needle 17 when viewed through the aperture 21 from the distal end D of the injection device 20. At least a part of the needle hiding element 30 may be opaque or translucent to reduce the visibility of the needle 17.

[0049] The needle hiding element 30 is disposed at the distal end D of the injection device 20. Figure 2 shows the needle hiding element 30 located at the distal end of the needle sleeve 19 proximate the aperture 21. The needle hiding element 30 may be coupled to the needle sleeve 19, such as to an inner surface 19a of the needle sleeve 19.

[0050] The needle hiding element 30 is movable between a first position and a second position relative to the needle sleeve 19. The needle hiding element 30 is positioned to cover a larger portion (i.e., area) of the aperture 21 when in the second position than when in the first position. Thus, visibility of the needle 17 through the aperture 21 is less obscured when the needle hiding element 30 is in the second position than when the needle hiding element 30 is in the first position. A biasing element can bias the needle hiding element 30 toward the second position. Thus, the needle 17 can be more obscured by default with little or no input from the user.

[0051] Figure 2 shows the needle hiding element 30 in a first position. Figure 3 shows the same injection device 30 as in Figure 2, but in a second position. The needle hiding element 30 may be coupled to the needle sleeve 19 when in the first position and remain coupled to the needle sleeve 19 when in the second position.

[0052] The needle hiding element 30 can assume several forms, as will be described below.

[0053] Figure 2 shows a needle hiding element 30 including multiple flaps 31. In the cross section of Figure 2, only a first flap 31a and a second flap 31b are visible, but as shown more clearly in Figures 4, 5, 7 and 8, there are actually six flaps 31 in the needle hiding element 30. However, it should be understood that the number of flaps 31 is not limited to six and can be more or less than six. For example, one flap 31 or two or more flaps 31 can be used.

[0054] Each flap 31 a,b is connected to the needle sleeve 19. Figure 2 shows that each flap 31 a,b is connected to the inner surface 19a of the needle sleeve 19. However, the flap 31 can be connected to another part of the needle sleeve 19, for example to the outer surface 19b of the needle sleeve 19 or to the end surface 19c of the needle sleeve 19. The flap 31 is arranged circumferentially around the aperture 21 proximate to the distal end of the needle sleeve 19. The flap 31 is located between the needle 17 and the distal end of the injection device 20 when the injection device 20 is in an initial state before injection.

[0055] The flaps 31 are connected to the needle sleeve 19 by any suitable connection means, such as a hinge, a ball joint, or the like. Figure 2 shows a first flap 31a connected to the inner surface 19a of the needle shield 19 by a first hinge 34a and a second flap 31b connected to the inner surface 19a of the needle shield 19 by a second hinge 34b. The flaps 31 are connected so as to be movable between a first position and a second position. Figure 6, described below, shows one example of how the flaps 31 are connected to the needle sleeve 19.

[0056] Each flap 31 a,b has a respective resilient member 32a,b that acts as a biasing element to bias the respective flap 31 a,b towards the second position. Figure 2 shows that each resilient member 32a,b is formed from an elastic material and includes a protrusion extending from the respective flap 31 a,b. The resilient members 32a,b may be integrally formed with the respective flap 31 a,b.

[0057] Each resilient member 32a,b contacts the inner surface 19a of the needle sleeve 19. When the flap 31 is in the first position, the resilient members 32 are in a stressed state (e.g., compressed or elongated) and exert a force on the inner surface 19a of the needle sleeve 19 attempting to urge the flap 31 into the second position.

[0058] In some examples, each elastic member 32 is coupled to the needle sleeve 19 rather than to the flap 31, but contacts the respective flap 31 when the flap 31 is in the first position. In this case, the elastic members 32 are in a stressed state when the flap 31 is in the first position and exert a force on the respective flap 31 attempting to urge the flap 31 into the second position.

[0059] Any type of elastic member 32 suitable for biasing the flaps 31 from the first position to the second position can be used. For example, the elastic member 32 can include one or more springs, etc. Although FIGS. 2 and 3 show that each flap 31 has its own elastic member 32, the present disclosure is not limited to such examples. For example, one elastic member 32 may act as a biasing element for multiple flaps 31. In some cases, one elastic member 32 may act as a biasing element for all of the flaps 31.

[0060] In some examples, the elastic member 32 may include a living hinge, one side of which may be coupled to the needle sleeve 19 and the other side of which may be coupled to the flap 31. In this case, the flap 31 and the elastic member 32 may be integrally formed with the needle sleeve 19, for example, in an injection molding process. The living hinge may act as both a coupling means that couples the flap 31 to the needle sleeve 19 and a biasing element that biases the flap 31 from the first position toward the second position.

[0061] 2 shows the flaps 31 in a first position relative to the needle sleeve 19. In this case, each flap 31a,b extends in a direction perpendicular to the aperture 21 and substantially parallel to the longitudinal axis of the injection device 20.

[0062] Before an injection is made, the cap 12 is removed from the injection device 20 by pulling the cap 12 in the direction "F" along the longitudinal axis of the injection device 20. When the cap 12 is removed from the injection device 20, the needle shield 25 exposes the needle 17.

[0063] Figure 3 shows the injection device 20 of Figure 2 after the cap 12 has been removed. The needle 17 is now exposed within the needle sleeve 19. However, the flaps 31 have now moved from their first position to their second position, hiding the needle 17 when viewed through the aperture 21 from the distal end of the injection device 20. The flaps 31 have each pivoted from the first position to the second position about a respective axis that is substantially perpendicular to the longitudinal axis of the injection device 20.

[0064] The needle hiding element 30 has been moved from a first position to a second position in response to the removal of the needle cap 12 from the needle sleeve 19. In FIG. 2, the flap 31 was in the first position but was biased toward the second position by the resilient member 32. The flap 31 was against the outer surface 25a of the needle shield 25, which held the flap 31 in the first position. However, when the cap 12 and the needle shield 25 are removed, as shown in FIG. 3, the flap 31 is no longer held in the first position by the needle shield 25 and therefore automatically moves to the second position due to the force exerted by the resilient member 32.

[0065] When in the second position, the needle hiding element 30 still has an opening 35, which allows the needle 17 to pass through the needle hiding element 30 during an injection. However, the size of the opening 35 is smaller than the size of the aperture 21, which means that when the needle hiding element 30 is in the second position, the user is less able to see the needle 17 than when it is in the first position.

[0066] Although FIG. 2 shows that the flap 31 is held in the first position by the needle shield 25 of the cap 12, in other examples, the flap 31 may be held in the first position by another portion of the cap 12 other than the needle shield 25.

[0067] In some examples, the needle hiding element 30 includes a locking member configured to lock the needle hiding element 30 in the second position after the needle hiding element 30 moves from the first position to the second position. Locking the needle hiding element 30 in the second position can improve the safety of the device by limiting a user's access to the needle 17.

[0068] 2 and 3 are described as having a biasing element (e.g., elastic member 32) that biases the needle hiding element 30 toward the second position, in other examples such a biasing element may not be present. For example, the needle hiding element 30 may not be biased toward the second position and the needle hiding element 30 may still be movable between the first and second positions, for example by the action of the user.

[0069] Figure 4 is a three-dimensional view of a portion of the injection device 20 of Figure 2, as seen from the distal end of the injection device 20. As can be seen in Figure 4, the cap 12 is inserted into the needle sleeve 19. For illustrative purposes, in Figure 4, the needle sleeve 19 and the cap 12 are depicted as transparent to better show the arrangement of the flap 31 in the needle sleeve 19.

[0070] The cap 12 holds the flaps 31 in a first position such that the flaps 31 extend along a direction substantially parallel to the longitudinal axis of the injection device 20. As previously mentioned, although six flaps 31a-f are shown in Figures 4 and 5, there may be more or fewer flaps 31.

[0071] Figure 5 shows the injection device 20 of Figure 4 after the cap 12 has been removed. The flap 31 is now in the second position covering a substantial portion of the aperture 21 of the needle sleeve 19, as previously described with reference to Figure 3. The flap 31 remains connected to the needle sleeve 19 between the first and second positions, but the flap 31 now covers a larger portion of the aperture 21 when in the second position compared to the first position, as can be seen by comparing Figure 5 with Figure 4. The needle 17 is therefore hidden by the flap 31 in the second position.

[0072] When in the second position, the flap 31 still forms an opening 35 through which the needle 17 can protrude during injection, however, it can be seen from Figure 5 that the presence of the flap 31 in the second position reduces the visibility of the needle 17.

[0073] FIG. 6 shows an example of how the flap 31 can be connected to the needle sleeve 19, for example as shown in the injection device 20 of FIGS.

[0074] FIG. 6 shows that each flap 31 has a first protrusion 54a and a second protrusion 54b disposed on opposite sides of the flap 31a and extending along the same axis of rotation. Coupling members 57a, b, c protrude from the needle sleeve 19, and each coupling member 57 is circumferentially spaced apart from one another on the inner peripheral surface 19a of the needle sleeve 19. Each flap 31 is located between a respective pair of coupling members 57. The first protrusion 54a and the second protrusion 54b of each flap 31 are received in respective first receiving portions 55a and second receiving portions 55b of the coupling member 57, such that the flap 31 is rotatably coupled to the needle sleeve 19 and can pivot between a first position and a second position. In some examples, one or more of the protrusions 54 may be formed on the coupling member 57, while one or more of the corresponding receiving portions 55 may be formed on the flap 31.

[0075] Figure 7 shows the injection device 20 of Figures 2 and 4 as viewed end-on, from the distal end towards the proximal end along the longitudinal axis of the injection device 20. For purposes of illustration, the cap 12 is not shown in Figure 7. However, Figure 7 shows the flap 31 as it would be visible in a first position, for example when the cap 12 is coupled to the injection device 20, or immediately after removing the cap 12 before the flap 31 moves to a second position.

[0076] As can be seen from Fig. 7, the six flaps 31a-f are in their first position, and therefore cover only a relatively small portion of the aperture 21, when compared to the second position shown in Fig. 8. As a result, the needle 17 may be visible to the user when viewed from the distal end of the injection device 20 through the aperture. The elastic members 32a-f are in a stressed state between the inner surface 19a of the needle sleeve 19 and their respective flaps 31a-f, thereby biasing the flaps 31a-f towards the second position. However, it should be noted that in some examples, the elastic members 32 are not present, and therefore the flaps 31 are not biased towards the second position.

[0077] Figure 8 shows the same view of the injection device 20 of Figure 7, but with the flaps 31a-f now in the second position. This may occur after removal of the cap 12 from the injection device 20, for example after a non-zero period of time after removal, when the flaps 31 are allowed to move from the first position to the second position. The flaps 31a-f may have been moved to the second position by the elastic members 32a-f. It can be seen that a larger portion of the aperture 21 is covered by the flaps 31 when in the second position of Figure 8, compared to the first position of Figure 7.

[0078] When in the second position, the flaps 31 still form an opening 35 through which the needle 17 can protrude during an injection. However, it can be seen from Figure 7 that in the second position, the presence of the flaps 31a-f reduces the visibility of the needle 17. The presence of the flaps 31a-f in the second position reduces the amount of light entering the needle sleeve 19 through the aperture 21, making the needle 17 less visible.

[0079] Although needle hiding element 30 has been discussed with reference to FIGS. 2-8 as including a plurality of flaps 31, the present disclosure is not limited to such examples.

[0080] 9-12 show another embodiment according to an aspect of the present disclosure.

[0081] 9 and 10 show an injection device 20 similar to that of FIGS. 2 and 3, but in which the needle hiding element 30 includes an iris diaphragm 37 instead.

[0082] An iris diaphragm 37 is connected to the needle sleeve 19 so as to extend across the aperture 21 .

[0083] The iris diaphragm 37 includes leaves 38, also known as vanes, arranged in a circular arrangement to form a central iris aperture 39. Each leaf 38 can pivot about an axis extending parallel to the longitudinal axis of the injection device 20. By pivoting the leaves 38, the size of the iris aperture 39 can be changed. A smaller iris aperture 39 can make it less likely that the needle 17 will be visible through the aperture 21 compared to a larger iris aperture 38.

[0084] Figures 9 and 10 show the iris diaphragm 37 in a first position and a second position, respectively. In the first position, shown in Figure 9, the iris opening 39 is larger than in the second position, shown in Figure 10. Thus, the needle 17 is only partially hidden by the iris diaphragm 37 when viewed from the distal end of the injection device 20 through the aperture 21.

[0085] In the second position shown in Figure 10, the iris opening 39 is smaller than in the second position shown in Figure 9. Thus, when viewed through the aperture 21 from the distal end of the injection device 20, the needle 17 is obscured by the iris diaphragm 37 to a greater extent than when it is in the first position. It can be seen in Figure 10 that when the iris diaphragm 37 is in the second position, the iris opening 39 acts as an opening 35, thereby allowing the needle 17 to protrude through the iris diaphragm 37 during injection.

[0086] The iris diaphragm 37 can be biased towards the second position by a biasing element in a similar manner as discussed for the other embodiments. This can be achieved, for example, by a resilient member 32 coupled to one or more leaves 38 of the iris diaphragm 37. When the cap 12 is coupled to the injection device 20, the iris diaphragm 37 can be held in the first position in a similar manner as described in relation to FIG. 2. That is, the leaves 38 can be biased against the outer surface 25a of the needle shield 25 by the resilient member 32. When the cap 12 is removed, the leaves 38 are no longer held in place by the needle shield 25, and so the iris diaphragm 37 moves to the second position due to the force exerted by the resilient member 32.

[0087] Figure 11 shows the injection device 20 of Figure 9 as viewed end-on, from the distal end towards the proximal end along the longitudinal axis of the injection device 30. For purposes of illustration, the cap 12 is not shown in Figure 11. However, Figure 11 shows the iris diaphragm 37 as it would be visible in a first position, for example when the cap 12 is coupled to the injection device 20, or immediately after removing the cap 12 before the iris diaphragm 37 moves to a second position.

[0088] As can be seen from FIG. 11, the leaves 38 of the iris diaphragm 37 are in their first position, forming a relatively large iris opening 39. Thus, the iris diaphragm 37 covers only a relatively small portion of the aperture 21 of the needle sleeve 19, when compared to the iris diaphragm 37 in the second position shown in FIG. 12. As a result, the needle 17 may be visible to the user when viewed from the distal end of the injection device 20 through the aperture. The iris diaphragm 37 may be biased toward the second position by a biasing element. However, it should be noted that in some examples, a biasing element is not present, and therefore the iris diaphragm 37 is not biased toward the second position. Instead, the iris diaphragm 37 may be moved between the first and second positions by the user.

[0089] FIG. 12 shows the same view of the injection device 20 of FIG. 11, but this time with the iris diaphragm 37 in the second position. This may occur after removal of the cap 12 from the injection device 20, for example after a non-zero period after removal, when the iris diaphragm 37 is allowed to move from the first position to the second position. The iris diaphragm 37 may have been moved to the second position by a biasing element. The leaves 38 of the iris diaphragm 37 have moved to form a smaller diaphragm opening 39 than when in the first position. It can thus be seen that a larger portion of the aperture 21 is covered by the iris diaphragm 37 when in the second position of FIG. 12, compared to the first position of FIG. 11.

[0090] The iris aperture 39 still acts as the opening 35 when the iris diaphragm 37 is in the second position, through which the injection needle 17 can protrude during an injection. However, it can be seen from Figure 12 that the presence of the iris diaphragm 37 in the second position reduces the visibility of the needle 17. The presence of the iris diaphragm 37 in the second position reduces the amount of light entering the needle sleeve 19 through the aperture 21, making the needle 17 less visible.

[0091] 13-16 show another embodiment according to aspects of the present disclosure. The injection device 20 is similar to the injection device of FIGS. 2-12, but in this embodiment the needle hiding element 30 includes an elastic diaphragm 41. The elastic diaphragm 41 is coupled to the needle sleeve 19 and extends across at least a portion of the aperture 21. The elastic diaphragm 41 is shown coupled to the inner surface 19a of the needle sleeve 19, but may alternatively be coupled to the outer surface 19b or end surface 19c of the needle sleeve 19. The elastic diaphragm 41 may be formed from an elastic or viscoelastic material. The elastic diaphragm 41 is a flexible piece of material that can change its shape.

[0092] Figure 13 shows the elastic diaphragm 41 in its first position, for example when the cap 12 is attached to the injection device 20. The elasticity of the elastic diaphragm 41 biases it towards its second position shown in Figure 14, but the presence of the cap 12 (i.e. the needle shield 25) holds the elastic diaphragm 41 in the first position.

[0093] Figure 14 shows the elastic diaphragm 41 of Figure 13 when in the second position, for example some time after the cap 12 has been removed from the injection device 20. The elasticity of the elastic member 41 causes it to return to the second position and expand, increasing its surface area to cover a larger portion of the aperture than when it was in the first position. Thus, the visibility of the needle 17 is less clear than when the elastic diaphragm 41 is in the first position. The elastic diaphragm 41 still has an opening 35 through which the needle 17 can protrude during injection.

[0094] Figures 15 and 16 show the injection device 20 of Figures 13 and 14, respectively, as viewed along the longitudinal axis of the injection device 20 from the distal end of the injection device 20 towards the proximal end of the injection device 20.

[0095] When the elastic diaphragm 41 is in the first position, as shown in Figure 15, it covers a relatively smaller area of ​​the aperture 21 compared to when it is in the second position as shown in Figure 16. Thus, the visibility of the needle 17 is less apparent when the elastic diaphragm 41 is in the second position than when it is in the first position. The elasticity of the material of the elastic diaphragm 41 biases the elastic diaphragm 41 towards the second position.

[0096] In the examples of Figures 13-16, the elastic diaphragm 41 is shown as a sheet of flexible material coupled to the needle sleeve 19 that extends across the aperture 21. However, in other examples, the elastic diaphragm 41 may have a more three-dimensional structure. For example, Figures 17 and 18 show an injection device 20 similar to Figures 13 and 14, respectively, but in Figures 17 and 18, the elastic diaphragm 41 comprises a tube of elastic material that extends a more substantial distance down the length of the needle sleeve 19. In such examples, the elastic diaphragm 41 may be formed from a tube of elastic foam, such as polyurethane foam.

[0097] FIG. 17 shows the elastic diaphragm 41 in a first position and FIG. 18 shows the elastic diaphragm 41 in a second position. In the first position, the elastic foam tube is in a compressed state and the elastic diaphragm 41 is held in a compressed state by the needle shield 25 of the cap 12. FIG. 18 shows the injection device 20 after the cap 12 has been removed. The needle shield 25 is no longer located within the needle sleeve 19. The elastic foam tube moves from a compressed state to an expanded state, occupying a larger area inside the needle sleeve 19 and covering a larger portion of the aperture 21. The elastic diaphragm 41 moves from the first state to the second state due to the elasticity of the elastic diaphragm 41.

[0098] When the elastic diaphragm 41 is in the second position, as shown in FIG. 18, it has an opening 35 which allows the needle 17 to extend therethrough during an injection.

[0099] In each of the examples discussed herein, the needle hiding element 30 has been described as forming an opening 35 when in the second position to allow the needle 17 to extend through the needle hiding element 30 during the injection process. However, in some examples, the opening 35 may not be present when the needle hiding element 30 is in the second position. For example, if the needle hiding element 30 includes an elastic diaphragm 41, the elastic diaphragm 41 may expand to the second position such that any opening 35 is completely sealed. This may not only further hide the needle 17, but may also improve the safety of the injection device 20 and further reduce the possibility of ingress of foreign objects into the needle sleeve 19. However, in such a scenario, the needle hiding element 30 is configured such that the needle 17 can still extend through the needle hiding element 30 during the injection process. This may be achieved by the needle hiding element 30 being formed from a material that the needle 17 can pierce or that the needle 17 can deform through during the injection process.

[0100] In the various embodiments described above, it will be appreciated that the needle hiding element 30 is generally movable between a first position and a second position, and may be movable in a number of ways within the various embodiments described above, for example, by pivoting, bending, elastically deflecting, rotating, expanding, etc. In some examples, the needle hiding element 30 is movable from the first position to the second position. Additionally or alternatively, in some examples, the needle hiding element 30 is movable from the second position to the first position.

[0101] It will be appreciated that in the various embodiments described above, the needle hiding element 30 may be biased toward the second position. However, in some examples according to the invention, the needle hiding element 30 may not be biased toward the second position. For example, a user may manually move the needle hiding element 30 from the first position to the second position.

[0102] It will be appreciated that in the various embodiments described above, the needle hiding element 30 is generally held in a first position by the cap 12, and that removal of the cap 12 allows the needle hiding element to move from the first position to the second position. However, in some examples according to the invention, the cap 12 is not present. For example, the needle hiding element 30 may be held in the first position by another member. In still other examples, the needle hiding element 30 is not held in the first position, but is movable between the second position and the first position.

[0103] In the various embodiments described above, the needle hiding element 30 has been described as comprising an iris diaphragm 37 or an elastic diaphragm 41. However, it will be appreciated that other suitable types of diaphragms may be used as the needle hiding element 30, so long as the diaphragm is movable between a first position and a second position, and the diaphragm covers a greater portion of the aperture 21 when in the second position compared to when in the first position. For example, the diaphragm may have a variable aperture.

[0104] Providing a needle hiding element 30 that is movable between a first position and a second position is advantageous in that when in the first position it allows access to the needle 17 and the interior of the needle sleeve 19, but when in the second position it can obscure the visibility of the needle 17. For example, the first position can cause the cap 12, and in particular the needle shield 25, to be positioned within the needle sleeve 19 and around the needle 17. However, after the cap 12 is removed, the needle hiding element 30 moves to the second position to obscure the needle 17 from view by the user.

[0105] A needle hiding element 30 that is movable between a first position and a second position may be advantageous when the components of the injection device 20 are assembled through the aperture 21 and the needle shield 19. For example, one or more of the medicament container 18 or the needle 17 may need to be inserted into the housing 11 of the injection device 20 through the aperture 21 and the needle shield 19 prior to injection. The needle hiding element 30 may be in the first position to allow the medicament container 18 and / or the needle 17 to be loaded into the injection device 20 through the aperture 21 and the needle shield 19, but may move to the second position after loading is complete.

[0106] The embodiments of the injection devices described herein are configured to receive either a drug cartridge or a drug pre-filled syringe. As used herein, the term "drug container" is intended to encompass both drug cartridges and pre-filled syringes.

[0107] The term "drug" or "medicament" is used herein to describe one or more pharma- ceutical active compounds. As described below, a drug or medicament may include at least one small molecule or macromolecule or combinations thereof in various types of formulations for the treatment of one or more diseases. Exemplary pharma- ceutical active compounds may include small molecules, polypeptides, peptides, and proteins (e.g., hormones, growth factors, antibodies, antibody fragments, and enzymes), carbohydrates and polysaccharides, as well as nucleic acids, double-stranded or single-stranded DNA (including naked and cDNA), RNA, antisense nucleic acids such as antisense DNA and RNA, small interfering RNA (siRNA), ribozymes, genes, and oligonucleotides. Nucleic acids may be incorporated into vectors, plasmids, or molecular delivery systems such as liposomes. Mixtures of one or more of these drugs are also contemplated.

[0108] The term "drug delivery device" is intended to encompass any type of device or system configured to administer a drug to a human or animal body. Without limitation, the drug delivery device may be an injector device (e.g., a syringe, pen injector, autoinjector, large volume device, pump, perfusion system, or other device configured for intraocular, subcutaneous, intramuscular, or intravascular delivery), a skin patch (e.g., osmotic, chemical, microneedle), an inhaler (e.g., nasal or pulmonary), an implant (e.g., coated stent, capsule), or a delivery system for the gastrointestinal tract. The drugs described herein may be particularly useful in an injector device that includes a needle, e.g., a small gauge needle.

[0109] The drug or agent can be contained in a primary package or "drug container" adapted for use in a drug delivery device. The drug container can be, for example, a cartridge, syringe, reservoir, or other vessel configured to provide a chamber suitable for storage (e.g., short-term or long-term storage) of one or more pharma- ceutically active compounds. For example, in some cases, the chamber can be designed to store the drug for at least one day (e.g., from one day to at least 30 days). In some cases, the chamber can be designed to store the drug for about one month to about two years. Storage can be at room temperature (e.g., about 20° C.) or at refrigerated temperatures (e.g., from about −4° C. to about 4° C.). In some cases, the drug container can be or include a dual-chamber cartridge configured to separately store two or more components of a drug formulation (e.g., a drug and a diluent, or two different types of drugs), one in each chamber. In such cases, the two chambers of the dual-chamber cartridge can be configured to allow mixing between two or more components of a drug or agent prior to and / or during administration to the human or animal body. For example, the two chambers can be configured to be in fluid communication with each other (e.g., via a conduit between the two chambers) and to allow mixing of the two components by a user, if desired, prior to administration. Alternatively or additionally, the two chambers can be configured to allow mixing upon administration of the components to the human or animal body.

[0110] The drug delivery devices and drugs according to the present invention can be used for the treatment and / or prevention of many different types of disorders. Exemplary disorders include, for example, diabetes or complications associated with diabetes, such as diabetic retinopathy, thromboembolic disorders, such as deep vein thromboembolism or pulmonary thromboembolism. Further exemplary disorders are acute coronary syndrome (ACS), angina, myocardial infarction, cancer, macular degeneration, inflammation, hay fever, atherosclerosis and / or rheumatoid arthritis.

[0111] Exemplary drugs for the treatment and / or prevention of diabetes or complications associated with diabetes include insulin, e.g., human insulin, or a human insulin analog or derivative, glucagon-like peptide (GLP-1), a GLP-1 analog or GLP-1 receptor agonist, or an analog or derivative thereof, a dipeptidyl peptidase-4 (DPP4) inhibitor, or a pharma- ceutically acceptable salt or solvate thereof, or any mixture thereof. As used herein, the term "derivative" refers to any substance that is sufficiently structurally similar to the original substance so as to have substantially the same functionality or activity (e.g., therapeutic effect).

[0112] Exemplary insulin analogs are Gly(A21), Arg(B31), Arg(B32) human insulin (insulin glargine); Lys(B3), Glu(B29) human insulin; Lys(B28), Pro(B29) human insulin; Asp(B28) human insulin; human insulin in which the proline at position B28 is replaced by Asp, Lys, Leu, Val or Ala and Lys at position B29 may be replaced by Pro; Ala(B26) human insulin; Des(B28-B30) human insulin; Des(B27) human insulin and Des(B30) human insulin.

[0113] Exemplary insulin derivatives include, for example, B29-N-myristoyl-des(B30) human insulin; 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-ThrB29Lys B30 human insulin; B30-N-palmitoyl-ThrB29LysB30 human insulin; B29-N-(N-palmitoyl-gamma-glutamyl)-des(B30) human insulin; 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. Exemplary GLP-1, GLP-1 analogs and GLP-1 receptor agonists include, for example, lixisenatide / AVE0010 / ZP10 / Lyxumia, exenatide / exendin-4 / Byetta / Bydureon / ITCA650 / AC-2993 (a 39 amino acid peptide produced by the salivary glands of the flathead monster), liraglutide / Victoza, semaglutide, taspoglutide, synclear / albiglutide, dulaglutide, rExendin-4, CJC-1134-PC, PB-1023, TTP-054, Langrena These include: cefotide / HM-11260C, CM-3, GLP-1 Erigen, ORMD-0901, NN-9924, NN-9926, NN-9927, nodexene, Viadol-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.

[0114] An exemplary oligonucleotide is, for example, the cholesterol-lowering antisense therapeutic mipomersen / quinamro for the treatment of familial hypercholesterolemia.

[0115] Exemplary DPP4 inhibitors are vidagliptin, sitagliptin, denagliptin, saxagliptin, berberine.

[0116] Exemplary hormones include pituitary or hypothalamic hormones or regulatory active peptides and their antagonists, such as gonadotropins (follitropin, lutropin, chorion gonadotropin, menotropin), somatropine (somatropin), desmopressin, terlipressin, gonadorelin, triptorelin, leuprorelin, buserelin, nafarelin, and goserelin.

[0117] Exemplary polysaccharides include glycosaminoglycans, hyaluronic acid, heparin, low molecular weight heparin or very low molecular weight heparin or derivatives thereof, or sulfated polysaccharides, such as the above-mentioned polysaccharides in polysulfated form, and / or their pharmaceutically acceptable salts.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-F20 / Synvisc, sodium hyaluronate.

[0118] The term "antibody" as used herein refers to an immunoglobulin molecule or an antigen-binding portion thereof. Examples of antigen-binding portions of an immunoglobulin molecule include F(ab) and F(ab')2 fragments that retain the ability to bind to an antigen. The antibody can be a polyclonal antibody, a monoclonal antibody, a recombinant antibody, a chimeric antibody, a deimmunized or humanized antibody, a fully human antibody, a non-human (e.g., murine) antibody, or a single chain antibody. In some embodiments, the antibody has effector function and is capable of fixing complement. In some embodiments, the antibody has reduced or no binding ability to Fc receptors. For example, the antibody can be an isotype or subtype, an antibody fragment, or a mutant that does not support binding to Fc receptors, e.g., has a mutation or deletion of the Fc receptor binding region.

[0119] The term "fragment" or "antibody fragment" refers to a polypeptide (e.g., antibody heavy and / or light chain polypeptide) derived from an antibody polypeptide molecule that does not include the full-length antibody polypeptide but comprises at least a portion of the full-length antibody polypeptide that is still capable of binding to an antigen. An antibody fragment can include truncated portions of a full-length antibody polypeptide, but the term is not limited to such truncated fragments. Antibody fragments 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, and multispecific antibodies (e.g., diabodies, triabodies, tetrabodies), minibodies, chelating recombinant antibodies, tribodies or bibodies, intrabodies, nanobodies, small modular immunopharmaceuticals (SMIPs), binding domain immunoglobulin fusion proteins, camelized antibodies, and VHH-containing antibodies. Additional examples of antigen-binding antibody fragments are known in the art.

[0120] The term "complementarity determining region" or "CDR" refers to short polypeptide sequences in the variable regions of both heavy and light chain polypeptides that are primarily responsible for mediating specific antigen recognition. The term "framework region" refers to amino acid sequences in the variable regions of both heavy and light chain polypeptides that are not CDR sequences and are primarily responsible for maintaining the proper arrangement of the CDR sequences to allow antigen binding. Although the framework region itself typically does not directly participate in antigen binding, as is known in the art, certain residues in the framework region of a particular antibody 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.

[0121] Exemplary antibodies are anti-PCSK-9 mAbs (e.g., alirocumab), anti-IL-6 mAbs (e.g., sarilumab), and anti-IL-4 mAbs (e.g., dupilumab).

[0122] The compounds described herein can be used in pharmaceutical preparations that include (a) the compounds or their pharmaceutically acceptable salts, and (b) pharmaceutically acceptable carriers.The compounds can also be used in pharmaceutical preparations that include one or more other active pharmaceutical ingredients, or in pharmaceutical preparations in which the compounds or their pharmaceutically acceptable salts are the only active ingredient.Thus, the pharmaceutical preparations of the present disclosure encompass any preparation made by mixing the compounds described herein with a pharmaceutically acceptable carrier.

[0123] Pharmaceutically acceptable salts of any of the drugs described herein are contemplated for use in the drug delivery device. Pharmaceutically acceptable salts are, for example, acid addition salts and base salts. Acid addition salts are, for example, HCl or HBr salts. Base salts are, for example, salts with a cation selected from an alkali or alkaline earth metal, for example, Na+, or K+, or Ca2+, or an ammonium ion N+(R1)(R2)(R3)(R4), where R1 to R4 are each independently: hydrogen, an optionally substituted C1-C6-alkyl group, an optionally substituted C2-C6-alkenyl group, an optionally substituted C6-C10-aryl group, or an optionally substituted C6-C10-heteroaryl group. Further examples of pharma-ceutically acceptable salts are known to those skilled in the art.

[0124] Pharmaceutically acceptable solvates are, for example, hydrates or alkanolates, such as methanolates or ethanolates.

[0125] Those skilled in the art will understand that modifications (addition and / or removal) of the various components of the materials, formulations, devices, methods, systems, and embodiments described herein can be made without departing from the full scope and spirit of the invention, which encompasses such modifications and any and all equivalents thereof.

Claims

1. 1. An injection device comprising: Needle and; a needle sleeve surrounding the needle, the needle sleeve having an aperture and positioned such that the needle extends through the aperture during an injection process; a needle hiding element reversibly movable between a first position and a second position relative to the needle sleeve; the needle hiding element is coupled to the needle sleeve when in the first position and when in the second position, the needle hiding element being positioned to cover a larger portion of the aperture when in the second position than when in the first position; Here, the needle hiding element is biased toward the second position; The needle hiding element includes a plurality of flaps within the needle sleeve, the plurality of flaps pivotally coupled to the needle sleeve such that the plurality of flaps can pivot between a first position and a second position about an axis of rotation substantially parallel to the aperture; the needle hiding element is arranged to move from a first position to a second position in response to removal of the cap from the needle sleeve of the injection device; The injection device, wherein the needle hiding element is arranged to move from the second position to the first position in response to at least a portion of the cap being inserted into the needle sleeve of the injection device.

2. 10. The injection device of claim 1, further comprising a housing, wherein the needle is fixed relative to the housing and the needle sleeve is configured to move into the housing to expose the needle.

3. 10. The injection device of claim 1, further comprising a housing, wherein the needle sleeve is fixed relative to the housing and the needle is configured to move relative to the housing sleeve to expose the needle.

4. The at least one flap is connected to the needle sleeve by a living hinge, and the at least one flap is biased toward the second position by the living hinge. An injection device according to any one of claims 1 to 3,

5. An injection device according to any one of claims 1 to 4, wherein the needle hiding element is arranged to have an opening when in the second position, through which the needle can extend during the injection process.

6. An injection device according to any one of claims 1 to 5, wherein the needle hiding element is integrally formed with the needle sleeve.

7. An injection device according to any one of claims 1 to 6, wherein the needle hiding element is configured to lock in the second position in response to movement from the first position to the second position.

8. Further comprising a cap, the cap having a needle shield, wherein the needle shield is at least partially located within the needle sleeve; An injection device according to any one of claims 1 to 7, wherein the needle hiding element is held in a first position by the needle shield when the needle shield is at least partially located within the needle sleeve.

9. An injection device according to any one of claims 1 to 8 which is an auto-injector, a pen-injector, a safety syringe or a large volume injection device.

10. An injection device according to any one of claims 1 to 9, further comprising a container for containing a medicament.

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