A medicament delivery device

Abstract

A medicament delivery device (100; 200) comprising a needle (17), a needle cover (102; 202) moveable between a covered position in which the needle cover covers the needle and an uncovered position in which the needle is exposed from the needle cover, a needle cover bias configured to provide a needle cover biasing force to bias the needle cover (102; 202) into the covered position and a needle cover retainer (106; 206) configured to hold the needle cover in the uncovered position against the needle cover biasing force.

Description

[0001] A MEDICAMENT DELIVERY DEVICE

[0002] FIELD OF INVENTION

[0003] The present invention relates to a medicament delivery device, such as an auto-injector, and to a method of using a medicament delivery device such as an auto-injector.

[0004] BACKGROUND

[0005] Medicament delivery devices, such as auto-injectors, are known in the art for dispensing medicament to an injection site of a patient. Such medicament delivery devices typically comprise a retractable needle cover which is configured to move, when pressed against the skin of a user, between a first position in which the needle is covered by the needle cover to a second, or uncovered, position in which the needle is exposed from the needle cover for injection.

[0006] Typically such needle covers are biased, e.g. by a needle cover bias such as a spring, into a covered position in which the needle cover entirely covers a needle of the medicament delivery device. The needle cover bias provides that, after the injection is complete and the user stops pressing the needle cover against the skin of the patient, the needle cover is moved by the biasing force from the uncovered position back into the covered position. Thus, as the needle remains covered at all times apart from during the injection itself, the risk of stick injuries is reduced. In some devices, the needle cover is locked into the covered position after use.

[0007] There therefore exists a need for an improved medicament delivery device.

[0008] SUMMARY

[0009] The present invention aims to alleviate, at least to a certain extent, the problems and / or address at least to a certain extent the difficulties associated with the prior art. According to a first aspect of the present invention, there is provided a medicament delivery device comprising: a needle; a needle cover moveable between a covered position in which the needle cover covers the needle and an uncovered position in which the needle is exposed from the needle cover; a needle cover bias configured to provide a needle cover biasing force to bias the needle cover into the covered position; and a needle cover retainer configured to hold the needle cover in the uncovered position against the needle cover biasing force.

[0010] Thus, the present invention advantageously provides a medicament delivery device in which the “holding force", that is the force required to be applied by the user to press the device against their skin to keep the needle cover in the uncovered position against the biasing force provided by the needle cover bias, is reduced or even eliminated. Optionally, the needle is fixed, or is moveable to a fixed position, relative to a housing of the device. Optionally, the needle is locked in the fixed position by a lock.

[0011] Optionally, the needle cover retainer is configured to engage the needle cover so as to hold the needle cover in the uncovered position. Optionally, the needle cover is configured to move in a proximal direction of the medicament delivery device when moving from the covered position to the uncovered position. Optionally, the uncovered position may be a fully uncovered, or fully retracted position, of the needle cover in which the needle cover is restricted from moving further proximally. Optionally, the needle cover retainer is configured to resist or oppose the needle cover biasing force when the needle cover is held in the uncovered position. Optionally, the needle cover retainer is configured to hold the needle cover in the uncovered position in opposition to the needle cover biasing force. Thus, the risk of stick injuries before and after the dispensing of medicament from the medicament delivery device may be reduced.

[0012] Optionally, the medicament delivery device further comprises a plunger. Optionally, the plunger is configured to deliver medicament from the medicament delivery device.

[0013] Optionally, the needle cover retainer is configured such that axial displacement of the plunger causes the needle cover retainer to release the needle cover so as to allow the needle cover to move from the uncovered position to the covered position under the action of the needle cover biasing force.

[0014] Optionally, the medicament delivery device comprises a plunger release mechanism configured to release the plunger for dispensing medicament from the medicament delivery device, wherein the needle cover retainer is configured to release the needle cover from the uncovered position subsequent to the release of the plunger by the plunger release mechanism. Optionally, the plunger release mechanism is configured to release the plunger upon movement of the needle cover from the covered position e.g. to the uncovered position. Optionally, the needle cover retainer is configured to release the needle cover from the uncovered position at a predetermined position, or stroke distance, of the plunger. Optionally, the plunger release mechanism causes the needle cover retainer to release the needle cover from the uncovered position. Optionally, the medicament delivery device comprises a plunger drive, or a plunger bias, configured to drive the plunger in a distal direction of the medicament delivery device, for example to a dispensed position of the plunger or, for example, to deliver medicament from the medicament delivery device, for example through a needle thereof.

[0015] Optionally, the needle cover retainer comprises a latching member and a catch, and wherein the latching member is movable from a latched position in which the latching member is configured to engage the catch when the needle cover is in the uncovered position so as to hold the needle cover in the uncovered position against the needle cover biasing force, to a unlatched position in which the latching member is disengaged from the catch to release the needle cover so as to allow the needle cover to move from the uncovered position to the covered position under the action of the needle cover biasing force. Optionally, the latching member is configured to be biased out of engagement with the catch, for example by the needle cover bias or by a biasing force provided thereby acting upon the latching member. Optionally, the latching member is configured to engage the catch when the needle cover is in a fully uncovered or fully retracted position of the needle cover.

[0016] Optionally, the needle cover retainer is configured such that axial displacement of the plunger causes the latching member to move from the latched position to the unlatched position. Optionally, the needle cover retainer is configured such that axial displacement of the plunger causes the latching member to move from the latched position to the unlatched position so as to allow the needle cover to move to the covered position under the action of the needle cover biasing force provided by the needle cover bias.

[0017] Optionally, the needle cover retainer further comprises a blocking member, the blocking member being moveable from a blocking position in which the blocking member prevents the latching member from moving to the unlatched position, to a non-blocking position in which the blocking member does not prevent the latching member from moving from the latched position to the unlatched position. Thus, in the non-blocking position, the latching member is free to disengage from the catch under the action of the needle cover biasing force. Optionally, the blocking member is configured to engage, for example abuttingly engage, the latching member in the blocking position so as to prevent movement of the latching member to the unlatched position. Optionally, the blocking member is configured to resist the latching member from being biased out of engagement with the catch by the biasing force provided by the needle cover bias.

[0018] Optionally, the needle cover retainer comprises a collar rotatable about a longitudinal axis of the device, wherein the blocking member is rotationally coupled to the collar such that such that rotation of the collar about the longitudinal axis of the device causes the blocking member to move from the blocking position to the non-blocking position.

[0019] Optionally, the needle cover retainer is configured such that axial displacement of the plunger causes the blocking member to move from the blocking position to the nonblocking position, for example by causing a collar comprising the blocking member to rotate about a longitudinal axis of the device. Optionally, the blocking member is rotationally coupled to the collar. Optionally, the blocking member is integrally formed with the collar.

[0020] Optionally, the collar is configured to convert axial displacement of the plunger into rotational movement of the collar about the longitudinal axis so as to cause the blocking member to move from the blocking position to the non-blocking position upon axial displacement of the plunger. Optionally, the collar is configured to convert axial displacement of the plunger into rotational movement of the collar at a predetermined axial displacement of the plunger.

[0021] Optionally, the plunger comprises a plunger cam surface, and wherein the collar comprises a collar cam surface configured for camming engagement with the plunger cam surface such that axial displacement of the plunger causes the collar to rotate about the longitudinal axis of the device so as to cause the blocking member to move from the blocking position to the non-blocking position via camming engagement of the collar cam surface with the plunger cam surface. Optionally, at least one or both of the collar cam surface and the plunger cam surface comprises a ramped or inclined cam surface. Optionally, the plunger cam surface and the collar cam surface are configured to engage with each other at a predetermined axial displacement of the plunger.

[0022] Optionally, the medicament delivery device further comprises a housing and wherein the latching member is provided as a clip and wherein the catch is provided as a corresponding recess operatively coupled to the housing, and wherein the needle cover is held in the uncovered position by the needle cover retainer when the clip is in engagement with the recess. Optionally, the clip comprises a ramped surface configured to cam against an edge or surface of the recess so as to cause the clip to disengage from the recess under the action of the needle cover biasing force and thereby to cause the latching member to move from the latched position to the unlatched position to allow the needle cover to move to the covered position, for example under the action of the needle cover biasing force. Optionally, an axially extending projection of the needle cover comprises the clip at or towards an end thereof.

[0023] Optionally, the medicament delivery device further comprises a collar rotatable about a longitudinal axis of the device, wherein the latching member is rotationally coupled to the collar such that such that rotation of the collar about the longitudinal axis of the device causes the latching member to move from the latched position to the unlatched position. Optionally, the collar is rotatable additionally or alternatively about a longitudinal axis of the plunger, or about a displacement direction of the plunger.

[0024] Optionally, the collar is configured to convert axial displacement of the plunger into rotational movement of the collar about the longitudinal axis so as to move the latching member from the latched position to the unlatched position.

[0025] Optionally, the plunger comprises a plunger cam surface, and wherein the collar comprises a collar cam surface configured for camming engagement with the plunger cam surface such that axial displacement of the plunger causes the collar to rotate about the longitudinal axis so as to cause the latching member to move from the latched position to the unlatched position via camming engagement of the collar cam surface with the plunger cam surface. Optionally, one or both of the collar cam surface and the plunger cam surface comprises a ramped or inclined cam surface. Optionally, the latching member to is configured to rotate about the longitudinal axis of the device from the latched position to the unlatched position. Optionally, the latching member to is configured to rotate about the displacement direction of the plunger or about the longitudinal axis of the plunger from the latched position to the unlatched position. Optionally, the plunger cam surface and the collar cam surface are configured to engage with each other at a predetermined axial displacement of the plunger.

[0026] Optionally, the medicament delivery device further comprises a cartridge and a medicament in the cartridge.

[0027] Optionally, the catch comprises a projection biased to project radially inwardly from the needle cover. Optionally, the projection is configured such that movement of the needle cover towards the uncovered position causes the latching member to slidingly engage with the projection so as to push the projection radially outwardly, against the bias, to thereby allow movement of the projection past the latching member and into the latched position. Optionally, the latching member is a radially extending projection provided on the collar. Alternatively, the projection may be biased to project radially inwardly from the housing.

[0028] Optionally, the latching member is rotatable about a longitudinal axis of the device and / or of the plunger. Optionally, the collar, and optionally also the latching member, is rotatable with respect to the needle cover and / or the plunger.

[0029] Optionally, the device further comprises a plunger guide configured to resist rotation of the plunger during axial movement thereof, for example relative to the housing or to the collar.

[0030] According to a second aspect of the present invention, there is provided a method of using a medicament delivery device, the method comprising: moving a needle cover of the medicament delivery device from a covered position in which the needle cover covers a needle of the medicament delivery device, against a needle cover biasing force provided by a needle cover bias of the medicament delivery device, to an uncovered position in which the needle is exposed from the needle cover; and holding the needle cover against the needle cover biasing force in the uncovered position by a needle cover retainer of the medicament delivery device. Optionally, the method further comprises the step of releasing the needle cover from the uncovered position upon a predetermined axial displacement of a plunger.

[0031] Optionally, the method further comprises the step of releasing the plunger via a plunger release mechanism of the medicament delivery device when the needle cover is moved to the uncovered position.

[0032] These and other aspects of the invention will be apparent from and elucidated with reference to the embodiments described hereinafter.

[0033] BRIEF DESCRIPTION OF THE DRAWINGS

[0034] Embodiments of the invention will now be described, by way of example only, with reference to the accompanying drawings, in which:

[0035] FIG. 1 A is a schematic side view of a medicament delivery device that embodies the invention, and a removable cap.

[0036] FIG. 1 B is a schematic side view of the medicament delivery device of Fig. 1 A, with the cap removed from the housing, showing a needle and needle cover thereof.

[0037] Fig. 2 is a perspective view showing, in a disassembled state, a housing, a needle cover, a collar, a plunger and a needle cover retainer of a medicament delivery device according to a first embodiment of the present invention.

[0038] Fig. 3A a side cross section view of the medicament delivery device of Fig. 2, showing the needle cover retainer of the first embodiment in closer detail, and in particular showing a blocking member holding a latching member in engagement with a recess so as to hold the needle cover in the uncovered position.

[0039] Fig. 3B is a perspective view of the medicament delivery device of Fig. 2 with the housing removed for ease of illustration and with the plunger having not yet been released for axial displacement by a plunger release mechanism. Fig. 4 is another perspective view of the medicament delivery device of Fig. 2 with the housing removed for ease of illustration, and with the plunger having been released for dispensing medication and being located at the end of the plunger’s dispensing stroke length such that the medicament delivery device is in a fully dispensed configuration.

[0040] Fig. 5 shows a cross section detail end view showing the collar when the plunger is at the end of its stroke length and so showing that the axial displacement of the plunger has caused, by the engagement of corresponding camming surface provided on the plunger and collar respectively, rotation of the collar so as to move a blocking member out of engagement with a latching member so as to allow the latching member to disengage from a catch provided in the housing.

[0041] Fig. 6 shows perspective views of the movement of the needle cover into the uncovered position and the engagement of the latching member, in this embodiment provided as a clip, with a corresponding recess so as to hold the needle cover in the uncovered position, against a biasing force provided by a needle cover bias.

[0042] Fig. 7 is a perspective view showing, in a disassembled state, a needle cover, a collar, a plunger and a needle cover retainer of a medicament delivery device according to a second embodiment of the present invention.

[0043] Figs 8A and 8B are perspective cross section views of the showing the needle cover retainer of the second embodiment of Fig 7 in closer detail, and in particular showing the way the latching member engages the catch when the needle cover is moved from the covered position to the uncovered position.

[0044] Figs 9A and 9B show cross section detail end views, showing the movement of the collar when the plunger is at the end of its dispensing stroke length and the way in which the collar is rotated by the plunger such that the latching member of the collar has been moved out of engagement with the catch such that the needle cover is free to move to the uncovered position under the action of a needle cover biasing force.

[0045] DETAILED DESCRIPTION

[0046] A medicament delivery device, as described herein, may be configured to inject a medicament into a patient. For example, delivery could be sub-cutaneous, intra-muscular, or intravenous. Such a device could be operated by a patient or care-giver, such as a nurse or physician, and can include various types of safety syringe, pen-injector, or autoinjector. The device can include a cartridge-based system that requires piercing a sealed ampule before use. Volumes of medicament delivered with these various devices can range from about 0.5 ml to about 2 ml. Yet another device can include a large volume device ("LVD") or patch pump, configured to adhere to a patient's skin for a period of time (e.g., about 5, 15, 30, 60, or 120 minutes) to deliver a "large" volume of medicament (typically about 2 ml to about 10 ml).

[0047] In combination with a specific medicament, the presently described devices may also be customized in order to operate within required specifications. For example, the device may be customized to inject a medicament within a certain time period (e.g., about 3 to about 20 seconds for auto-injectors, and about 10 minutes to about 60 minutes for an LVD). Other specifications can include a low or minimal level of discomfort, or to certain conditions related to human factors, shelf-life, expiry, biocompatibility, environmental considerations, etc. Such variations can arise due to various factors, such as, for example, a drug ranging in viscosity from about 3 cP to about 50 cP. Consequently, a drug delivery device will often include a hollow needle ranging from about 25 to about 31 Gauge in size. Common sizes are 17 and 29 Gauge.

[0048] The medicament delivery devices described herein can also include one or more automated functions. For example, one or more of needle insertion, medicament injection, and needle retraction can be automated. Energy for one or more automation steps can be provided by one or more energy sources. Energy sources can include, for example, mechanical, pneumatic, chemical, or electrical energy. For example, mechanical energy sources can include springs, levers, elastomers, or other mechanical mechanisms to store or release energy. One or more energy sources can be combined into a single device. Devices can further include gears, valves, or other mechanisms to convert energy into movement of one or more components of a device.

[0049] The one or more automated functions of an auto-injector may each be activated via an activation mechanism. Such an activation mechanism can include an actuator, for example, one or more of a button, a lever, a needle cover, or other activation component. Activation of an automated function may be a one-step or multi-step process. That is, a user may need to activate one or more activation components in order to cause the automated function. For example, in a one-step process, a user may depress a needle cover against their body in order to cause injection of a medicament. Other devices may require a multi-step activation of an automated function. For example, a user may be required to depress a button and retract a needle cover in order to cause injection.

[0050] In addition, 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 needle insertion, medicament injection, and needle retraction. Some devices may also require a specific sequence of steps to cause the one or more automated functions to occur. Other devices may operate with a sequence of independent steps.

[0051] Some medicament delivery devices can include one or more functions of a safety syringe, pen-injector, or auto-injector. For example, a delivery device could include a mechanical energy source configured to automatically inject a medicament (as typically found in an auto-injector) and a dose setting mechanism (as typically found in a pen-injector). According to some embodiments of the present disclosure, an exemplary medicament delivery device 10 is shown in Figs. 1A & 1 B. Device 10, as described above, is configured to inject a medicament into a patient's body. Device 10 includes a housing 11 which typically contains a reservoir containing the medicament to be injected (e.g., a syringe) and the components required to facilitate one or more steps of the delivery process. Device 10 can also include a cap assembly 12 that can be detachably mounted to the housing 11. Typically a user must remove cap 12 from housing 1 1 before device 10 can be operated.

[0052] As shown, housing 1 1 is substantially cylindrical and has a substantially constant diameter along the longitudinal axis A-A. The housing 1 1 has a distal region D and a proximal region P. The term "distal" refers to a location that is relatively closer to a site of injection, and the term "proximal" refers to a location that is relatively further away from the injection site.

[0053] Device 10 also includes a needle cover 19 coupled to housing 1 1 to permit movement of cover 19 relative to housing 11 . For example, cover 19 can move in a longitudinal direction parallel to longitudinal axis A-A. Specifically, movement of cover 19 in a proximal direction can permit a needle 17 to extend from distal region D of housing 1 1 , or can permit the needle 17 to be exposed from the cover 19. Insertion of needle 17 can occur via several mechanisms. For example, needle 17 may be fixedly located relative to housing 11 and initially be located within an extended needle cover 19. Proximal movement of cover 19 by placing a distal end of cover 19 against a patient's body and moving housing 1 1 in a distal direction will uncover the distal end of needle 17. Such relative movement allows the distal end of needle 17 to extend into the patient's body. Such insertion is termed "manual" insertion as needle 17 is manually inserted via the patient's manual movement of housing 1 1 relative to cover 19.

[0054] Another form of insertion is "automated", whereby needle 17 moves relative to housing 1 1 . Such insertion can be triggered by movement of cover 19 or by another form of activation, such as, for example, a button 13. As shown in Figs. 1A & B, button 13 is located at a proximal end of housing 11 . However, in other embodiments, button 13 could be located on a side of housing 11 .

[0055] Other manual or automated features can include drug injection or needle retraction, or both. Injection is the process by which a bung or piston 14 is moved from a proximal location within a syringe 18 to a more distal location within the syringe 18 in order to force a medicament from the syringe 18 through needle 17. In some embodiments, a drive spring (not shown) is under compression before device 10 is activated. A proximal end of the drive spring can be fixed within proximal region P of housing 1 1 , and a distal end of the drive spring can be configured to apply a compressive force to a proximal surface of piston 14. Following activation, at least part of the energy stored in the drive spring can be applied to the proximal surface of piston 14. This compressive force can act on piston 14 to move it in a distal direction. Such distal movement acts to compress the liquid medicament within the syringe 18, forcing it out of needle 17.

[0056] Following injection, needle 17 can be retracted within cover 19 or housing 1 1. Retraction can occur when cover 19 moves distally as a user removes device 10 from a patient's body. This can occur as needle 17 remains fixedly located relative to housing 11 . Once a distal end of cover 19 has moved past a distal end of needle 17, and needle 17 is covered, cover 19 can be locked. Such locking can include locking any proximal movement of cover 19 relative to housing 11 .

[0057] Another form of needle retraction can occur if needle 17 is moved relative to housing 11 . Such movement can occur if the syringe 18 within housing 11 is moved in a proximal direction relative to housing 1 1. This proximal movement can be achieved by using a retraction spring (not shown), located in distal region D. A compressed retraction spring, when activated, can supply sufficient force to the syringe 18 to move it in a proximal direction. Following sufficient retraction, any relative movement between needle 17 and housing 11 can be locked with a locking mechanism. In addition, button 13 or other components of device 10 can be locked as required.

[0058] Turning now to Fig. 2, and with particular reference to Figs. 3A, 3B and 4, a housing 101 , needle cover 102, collar 103 and plunger 104 of a medicament delivery device 100 according to one embodiment of the present invention are shown in a disassembled state. The medicament delivery device of the first embodiment is an auto-injector. The needle cover 102 is moveable between a covered position, in which the needle cover entirely covers a needle 17 (see Fig. 1), for example the end of a needle 17, and an uncovered position in which the needle 17 is exposed from the needle cover 102, so as to allow medicament provided within a cartridge 18, when such a cartridge is provided, to be dispensed from the medicament delivery device 100 through needle 17. In the uncovered position, the needle cover 102 has moved axially in a proximal direction and may in some embodiments be received in the uncovered position at least partially within the housing 101. The needle cover 102 may be moved manually from the covered to the uncovered position, for example by a user pressing the distal end of the needle cover 102 against their skin. In this embodiment, the needle cover 102 is slidably received within the housing 101 and in some embodiments both are rotationally fixed with respect to each other.

[0059] The medicament delivery device 101 comprises a plunger bias 114, or plunger drive, which may for example comprise a drive spring 114 (see Fig. 4). Plunger bias 1 14 is configured to drive a plunger 104 in a distal direction of the medicament delivery device 100 so as to drive a bung 14 (see Fig. 1) of a medicament cartridge 18 also in a distal direction of the device 100, so as to deliver medicament from the needle 17. The plunger 104 in some embodiments has a predetermined axial stroke length. The predetermined axial stroke length is the axial distance through which the plunger 104 is moved by the plunger bias 114 during dispensing, for example from an initial first position of the plunger 104 to a fully dispensed position of the plunger 104. The predetermined axial stroke length may be determined by the axial distance the bung 14 (Fig. 1) is able to move within an internal volume of the cartridge 18 (Fig. 1). In some embodiments, the axial distance the bung 14 is able to move is limited by an internal wall of distal end of the cartridge 18 which serves as a bung stop or plunger stop. The medicament delivery device 100 also comprises a needle cover bias (not shown) which is configured to bias the needle cover 102 into the covered position. Such needle cover biases are well known in the art and so will be readily understood by a skilled person. When a user removes the device 100 from their skin, the needle cover 102 is caused to move under the biasing force provided by the needle cover bias into the covered position. In this way, the time the needle 17 is exposed from the needle cover 102 is reduced and thereby the potential for stick injuries is reduced. In some embodiments, the needle cover bias is provided as a spring, for example a compression spring, configured such that one end thereof reacts off the housing 101 , or any other suitable part of the device, while the other end provides the biasing force by pressing against the needle cover 102.

[0060] The medicament delivery device 100 comprises a needle cover retainer 106, which may also be referred to as a needle cover lock, which is configured to hold, or lock, the needle cover 102 in the uncovered position. Thus, the needle cover retainer 106 is configured to resist or oppose the biasing force provided by the needle cover bias so as to hold the needle cover 102 in the uncovered position and to prevent the needle cover 102 from moving under the action of the needle cover biasing force to the covered position. In the locked / held uncovered position, the needle cover retainer 106 may also prevent the needle cover 102 from further uncovering the needle, i.e. from moving further proximally. Thus, the needle cover retainer 106 may be configured to hold the needle cover 102 in a proximal-most position of the needle cover 102. By the needle cover retainer 106 holding the needle cover 102 in this way, the needle cover retainer 106 fully resists and supports the biasing force applied to the needle cover 102 such that none of the biasing force is transferred to the user as a “holding force” in use, thus the needle cover retainer 102 eliminates the holding force of the device 100 that the user must apply to the needle cover 102 during the injection, thereby providing an easier to use medicament delivery device 100.

[0061] The needle cover retainer 106 comprises a latching member 107 and a catch 108. The latching member 107 has a latched position in which the latching member 107 engages, e.g. is received within a recess 109 of, the catch 108 when the needle cover 102 is in the uncovered position so as to hold the needle cover 102 in the uncovered position. The latching member 107 is moveable from the latched position to an unlatched position in which the latching member 107 is disengaged from the catch 108 such that the needle cover 102 is no longer held in the uncovered position. The latching member 107 may also be referred to as a lock or lock member and the recess may be referred to as a locking recess or locking formation.

[0062] In this embodiment, the latching member 107 comprises a clip 110 provided in the needle cover 102 which is configured to be received by catch 108 which in this embodiment is provided as a corresponding recess 109 in the housing 101. Thus, when the clip 110 is received within the recess 109, the needle cover 102 is axially locked to, or held with respect to, the housing 101 in at least one axial direction of the device 100, but in some embodiments the clip 110 may lock / hold the needle cover 102 with respect to the housing 101 in both axial directions of the device 100. Thus, when a user presses against the needle cover 102, against the biasing force provided by the needle cover bias, the needle cover 102 is caused to move, e.g. slide, axially in a proximal direction within the housing 101 from the covered position to the uncovered position until clip 110 engages recess 109 and therefore the latching member, i.e. clip 1 10, moves from an unlatched position to a latched position and so the needle cover is held in the uncovered position. A clip stop 111 , which in this embodiment is provided as a ramped or inclined surface on the clip 110, prevents further movement of the needle cover 102 in the proximal direction. Upon engagement of the clip 110 with the recess 109, the holding force is eliminated, or at least substantially reduced, as the needle cover 102 held in the uncovered position and is prevented from moving distally under the action of the needle cover bias to the covered position by the engagement of the clip 110 with the recess 109.

[0063] In this specific embodiment, the clip 1 10 comprises a cam, or ramped, surface 112 which, under the action of the needle cover bias, cams against an edge or surface of the recess 109 causing the clip 1 10 to disengage from the recess 109. In this way, the clip 110 of latching member 107 is biased into the unlatched position, i.e. is biased out of engagement with the recess 1 10, in this embodiment by the needle cover bias although the clip 110 could be biased in other ways, for example by providing a living hinge.

[0064] As the ramped surface 112 engages the edge or surface of the recess 109, the clip 110 is caused to move radially inwardly from the latched position to the unlatched position. Thus, the ramped surface 112 can be seen to be configured to convert the axial force provided by the needle cover bias into a radially inward movement of the clip 1 10 so as to cause / bias the clip 110 to disengage from the recess 109 and thereby move from the latched position to the unlatched position. Thus, the needle cover bias is configured to overcome the engagement of the clip 110 with the recess 109. Because in this embodiment the latching member 107, in this embodiment clip 110, is biased out of engagement with its corresponding catch 108, in this embodiment recess

[0065] 109, a blocking member 1 13 is provided which prevents, or blocks or resists, the disengagement of the latching member 107 from the catch 108 in the uncovered position so as to hold the needle cover 102 in the uncovered position. Thus, the blocking member 113 blocks movement of the latching member 107 from the latched position to the unlatched position.

[0066] In this embodiment the blocking member 113 is moveable between, or from, a blocking position in which the blocking member 113 prevents the latching member from moving from the latched position to the unlatched position to a non-blocking position in which the blocking member does not prevent the latching member 113 from moving from the latched position to the unlatched position. In other words, the latching member 107 is movable from a latched position to a release position in which the latching member is released for movement from the latched position to the unlatched position so as to cause the latching member 107, or more generally the needle cover retainer 106, to release the needle cover 102 for movement to the covered position.

[0067] As can be seen from for example Figs. 3A and 3B, the blocking member 1 13 is configured to abuttingly engage the latching member 107 in the blocking position so as to prevent the latching member 107 moving to the unlatched position. In this embodiment and, as shown in these figures, the blocking member 107 is arranged in the blocking position so as to be adjacent to the clip 1 10 so as to prevent the clip from moving radially inwardly under the camming force provided by the needle cover bias and thereby disengaging from the recess 109. Specifically, the blocking member 107 is arranged radially inwardly of the clip

[0068] 110.

[0069] The way in which the blocking member 1 13 is moved from the blocking position to the non-blocking position can be best seen in Fig. 4. A plunger release mechanism (not shown) is configured to release the plunger 104 for dispensing medicament from the medicament delivery device 100 under the action of the plunger driver or plunger bias which may comprise, for example, a compression spring 114, for driving the movement of the plunger 104 in an axial, e.g. distal, direction so as to drive medicament from a cartridge of the device 100. Thus, when the plunger release mechanism releases the plunger 104, the plunger 104 is released for movement in an axial direction towards the distal end of the device. The collar 103, which is configured to rotate about the longitudinal axis of the device 100, for example circumferentially about the plunger 104 or about an axis which is colinear with the longitudinal axis of the plunger 104, is engaged by the plunger 104 at a predetermined stroke length of the plunger 104 or at a predetermined position of the plunger 104 relative to the housing 101 and / or cartridge, and in some embodiments the collar 103 is arranged generally at or towards a location corresponding with the end of the axial movement of the plunger 104. Thus, in some embodiments, the plunger 104 is configured to engage the collar 103 at, or towards or substantially at, a fully dispensed position of the plunger 104. The engagement of the plunger 104 with the collar 103 after the plunger 104 is released by the plunger release mechanism causes the collar 103 to rotate, thereby moving the blocking member 113 out of the blocking position and into the non-blocking position so as to release the latch member 107 for movement to the unlatched position, and thereby to allow the needle cover to move under the action of the needle cover biasing force to the covered position.

[0070] As can be seen in Fig. 4 but also in Fig. 3B and Fig. 5, the plunger 104 comprises two diametrically opposed ramped plunger surfaces 115 which each engage with correspondingly diametrically opposed ramped collar surface 1 16 of the collar 103. In some embodiments only one such ramped plunger surface 1 15 and ramped collar surface 116 is provided, and in other embodiments only one of the collar 103 and the plunger 104 comprises such a ramped surface 115. These ramped surfaces may in some embodiments be inclined surfaces. In some embodiments the ramped surface 116 of the collar 103 is provided on an axially extending projection or protrusion of the collar 103. Camming engagement of the ramped surface 115 of the plunger 104 with the corresponding ramped surface 1 16 of the collar 103 upon engagement of the plunger 104 with the collar 103 converts the axial movement of the plunger 104 to rotational movement of the collar 103 so as to move the blocking member 1 13 from the blocking position into the non-blocking position. In this embodiment, the blocking member 113 and the collar 103 are rotationally coupled to each other such that they rotate together and so the blocking position and the non-blocking positions can therefore be seen to correspond to rotational positions of the collar 103.

[0071] Turning now to Fig. 6, with the blocking member 1 13 having been moved to the nonblocking position as a result of the plunger 104 having moved to the end of its stroke length corresponding to a fully dispensed position of the plunger 104, ramped surface 112 of clip 110 is caused to engage an edge or surface of the recess 109 under the action of the biasing force provided by the needle cover bias so as to cause the clip 110 to become radially inwardly depressed so as to disengage from the recess 109 and therefore to cause the clip 1 10 to move into the unlatched position. Thus, the needle cover 102 is now free to move under action of the needle cover biasing force to the covered position.

[0072] In this way, the axial displacement of the plunger 104 causes the latching member 107, in this embodiment the clip 1 10, to move from the latched position to the unlatched position.

[0073] It can therefore be seen that the axial displacement the plunger 104, having been released by the plunger release mechanism, causes the latching member 107 to move from the latched position to the unlatched position. Specifically, the axial movement, or axial position or axial displacement, of the plunger 104 causes the latching member 107 to move from the latched position to the unlatched position at a predetermined axial displacement or position of the plunger 104, which may in some embodiments correspond to an end position, or a fully dispensed position, of the plunger 104.

[0074] In this way, the needle cover retainer 106 is configured to release the needle cover 102 from being held in the uncovered position subsequent to the release of the plunger 104 by the plunger release mechanism. Similarly, the plunger release mechanism is configured to release the plunger 104 upon movement of the needle cover 102 from the covered position, e.g. into the uncovered position.

[0075] In some embodiments, although not shown in the figures, the medicament delivery device 100 may comprise a plunger guide for restricting rotation of the plunger 104, for example with respect to the collar 103 or to the housing 101. Such a guide may for example comprise one or more axially extending guide rails provided, for example, in the housing. The guide may guide axial movement of the plunger 104 while preventing, or substantially preventing or limiting, rotation of the plunger with respect to the collar 103, for example.

[0076] Turning now to Fig. 7, certain parts of a medicament delivery device 200 showing the needle cover retainer according to a second embodiment of present invention is shown. Similar to the first embodiment above, the medicament delivery device 200 of the second embodiment is also an auto-injector. The medicament delivery device 200 comprises also a needle (not shown), needle cover 202 and needle cover bias (not shown), plunger 204, plunger bias / drive 217, plunger release mechanism (not shown), catch 208, latching member 207, collar 203 and a needle cover retainer 206, and so on. This second embodiment however differs from the first embodiment in the way the needle cover retainer 206 is configured in that the catch 208 of the second embodiment is provided as an inwardly biased finger or projection 218 provided on the needle cover 202 which is configured to engage with a latching member 107 provided on the rotatable collar 203.

[0077] A detailed view of the second embodiment can be seen in for example in Figs. 8A and 8B. Fig. 8A shows the medicament delivery device in a configuration in which the needle cover 202 is in its covered position and prior to the medicament delivery device 200 being used by a user, that is prior to the release of the plunger 204. In the same way as in the first embodiment, a collar 203 is arranged circumferentially around plunger 204 and the collar 203 is rotatable with respect to the plunger 204 about the longitudinal axis of the plunger 204. The longitudinal axis of the plunger 204 is the axis defined by the direction of travel of the plunger and which extends from a proximal end of the device to a distal end of the device. A plunger bias, or plunger drive 217, is provided within a longitudinally extending bore of the plunger 204 and the plunger bias 217 is configured to bias, or drive, the plunger 204 from a non-dispensed position to a dispensed position for dispensing medicament from the medicament delivery device 200 when a cartridge 18 (Fig. 1) of medicament is provided therein. In this embodiment, as well as in the first embodiment, the plunger bias 217 comprises a compression spring 217, although any other suitable means for providing a plunger biasing force could instead be used. Finally, each of these components is arranged within the needle cover 202, for example within a longitudinally extending hollow of the needle cover 202.

[0078] The collar 203 comprises a latching member 207 which in this embodiment comprises a radially outwardly projecting protrusion or member 218. The latching member 207 has a latch engagement surface 220 configured for abutting engagement with the catch 208 so as to axially retain the latching member 207 with respect to the catch 208 and thereby hold the needle cover in the uncovered position. The latching member 207 also comprises a latch slide surface 221 configured to slidingly engage with a corresponding slide surface 222 of the catch 222. The latch slide surface 221 and the latch engagement surface 220 are axially spaced apart such that the latch slide surface 221 slidingly engages with the catch slide surface 222, as the needle cover is moved to the uncovered position, before the latch engagement surface 220 engages the catch 208 for holding the needle cover 202 in the uncovered position.

[0079] In this embodiment the catch 208 is provided as a radially inwardly projecting projection or finger 218 provided on the needle cover 202. The latching member 207 is moveable between, e.g. from, a first position in which the finger 218 of the catch 208 is positioned for engagement with the latching member 207, and therefore in which the needle cover 202 is held in the uncovered position, to a second position in which the finger 218 of the catch 208 is disengaged from the latching member 207 and so in which the needle cover 202 is released from being held in the uncovered position for movement to the covered position.

[0080] The finger 218 is moveably coupled to the needle cover 202 and specifically, in this embodiment, the finger 218 is pivotably coupled to the needle cover 202 by a pivot 223 defining a pivot axis about which the finger 218 is pivotable. The pivot in this embodiment is provided as a living hinge 224 provided at the base of the finger 218, adjoining the finger 218 and the needle cover 202. The living hinge 224 advantageously additionally serves as a bias, although the pivot and bias could be provided separately, which biases the finger 218 inwardly into the first position, as shown in Fig 8A. An optional neck 225 may be provided in the living hinge 224 and may be appropriately sized so as to provide a desired biasing force for biasing the finger 218 into the first position.

[0081] In use, as shown by arrow A in Fig. 8A, when the user moves or pushes, e g. against a needle cover biasing force provided by a needle cover bias (not shown) configured to bias the needle cover 202 into the covered position, the needle cover 202 from the covered position to the uncovered position, for example when a user presses the medicament delivery device 200 against their skin, the needle cover 202 is caused to move in a proximal direction from the covered position to the uncovered position so as to expose the needle from the needle cover 202. As the needle cover 202 so moves, the latch slide surface 221 slidingly engages with the catch slide surface 222 provided on an underside, i.e. radially innermost, surface of the finger 218 of catch 208. A tip of the finger 218, comprising a catch formation 226 configured for engagement with the latching member 207, extends inwardly past the latch slide surface 221 such that, as the needle cover 202 moves proximally (as indicated by arrow A), the catch slide surface 222 slidingly engages with the latch slide surface 221 , against the biasing force provided by the living hinge 224, and causes the finger 218 to pivot outwardly (as indicated by arrow B) such that the finger 218 slides against and past the latching member 207 as the needle cover 202 is moved to the uncovered position.

[0082] Once the needle cover 202 has been moved a pre-determined distance in the proximal direction until it has reached the uncovered position, the finger 218 moves past the latching member 207 and so, under the action of the biasing force provided by the living hinge 224, the finger 218 now moves radially inwardly to define a stop 226 provided in the tip of the finger 218 and which engages with the latching member 207 to prevent the needle cover 202 moving distally under the action of the needle cover bias back to the covered position. Thus, the engagement of the stop 226 of the catch 208 with the latching member 207 holds the needle cover 202 in the uncovered position and therefore forms part of a needle cover retainer 206. The uncovered position is shown in Fig. 8B in which the latching member 207 is in the latched position and is in engagement with the catch 208, forming part of the needle cover retainer 206 and holding the needle cover 202 in the uncovered position, against the biasing force provided by the needle cover bias (not shown) biasing the needle cover 202 in the opposite direction to that shown by Arrow A.

[0083] Turning now to Figs. 9A and 9B, the plunger release mechanism and the way in which the plunger, after having been released by the plunger release mechanism, releases the needle cover 202 from being held in the uncovered position by the needle cover retainer 206 can be seen. When, or in some embodiments after, the needle cover 202 is moved into the uncovered position, a plunger release mechanism (not shown) is triggered and, as such, a plunger drive 217, in this example comprising a plunger drive spring 217, drives the plunger 204 in a distal direction for the dispensing of medicament from the medicament delivery device 200 towards a fully dispensed position. The fully dispensed position may be defined by the plunger 204, or by a catridge bung, engaging a stop for example provided in a medicament cartridge 18 and in some embodiments the stop may be defined by an end surface of a bore provided in the cartridge 18.

[0084] Upon reaching a predetermined displacement, or stroke length, of the plunger 204, for example when the plunger 204 reaches the fully dispensed position, or just before, a collar cam surface 216, or ramped surface 216, is caused to engage with a plunger cam surface 215, or ramped surface 215, so as to convert the axial movement of the plunger 204 to rotational movement of the collar 203 about the plunger 204. The needle cover 202 is rotational decoupled from the collar 203 such that the collar 203 rotates with respect to the needle cover 202. As the collar 203 rotates, so does the latching member 207 with it and so the latching member 207 is thereby moved out of engagement with the catch 208, thereby causing the latching member 207 to move from a latched position in which the needle cover 202 is held in the uncovered position to an unlatched position in which the needle cover 202 is released from being held in the uncovered position. Having been released from the uncovered position, the needle cover 202 is caused to move under the biasing force provided by the needle cover bias back to the covered position, in this way, the needle cover retainer 206 releases the needle cover 202 from being held in the uncovered position subsequent to the release of the plunger 204 by the plunger release mechanism and furthermore, in this way axial displacement of the plunger 204, having been released by the plunger release mechanism, causes the needle cover retainer 206 to release the needle cover 202, by moving the latching member from the latched position to the unlatched position, for movement of the needle cover 202 to the covered position.

[0085] It can therefore be seen that, in both the first and second embodiments, movement of the needle cover to the uncovered position causes both the plunger to be released for axial movement and the needle cover retainer to hold the needle cover in the uncovered position. The needle cover is then released for movement back to the covered position upon a predetermined axial displacement of the plunger and, once released, the needle cover is moved back to the covered position under the action of a needle cover biasing force.

[0086] The terms “drug” or “medicament” are used synonymously herein and describe a pharmaceutical formulation containing one or more active pharmaceutical ingredients or pharmaceutically acceptable salts or solvates thereof, and optionally a pharmaceutically acceptable carrier. An active pharmaceutical ingredient (“API”), in the broadest terms, is a chemical structure that has a biological effect on humans or animals. In pharmacology, a drug or medicament is used in the treatment, cure, prevention, or diagnosis of disease or used to otherwise enhance physical or mental well-being. A drug or medicament may be used for a limited duration, or on a regular basis for chronic disorders.

[0087] As described below, a drug or medicament can include at least one API, or combinations thereof, in various types of formulations, for the treatment of one or more diseases. Examples of API may include small molecules having a molecular weight of 500 Da or less; polypeptides, peptides and proteins (e.g., hormones, growth factors, antibodies, antibody fragments, and enzymes); carbohydrates and polysaccharides; and nucleic acids, double 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 molecular delivery systems such as vectors, plasmids, or liposomes. Mixtures of one or more drugs are also contemplated.

[0088] The drug or medicament may be contained in a primary package or “drug container” adapted for use with a drug delivery device. The drug container may be, e.g., a cartridge, syringe, reservoir, or other solid or flexible vessel configured to provide a suitable chamber for storage (e.g., short- or long-term storage) of one or more drugs. For example, in some instances, the chamber may be designed to store a drug for at least one day (e.g., 1 to at least 30 days). In some instances, the chamber may be designed to store a drug for about 1 month to about 2 years. Storage may occur at room temperature (e.g., about 20°C), or refrigerated temperatures (e.g., from about - 4°C to about 4°C). In some instances, the drug container may be or may include a dual-chamber cartridge configured to store two or more components of the pharmaceutical formulation to-be- administered (e.g., an API and a diluent, or two different drugs) separately, one in each chamber. In such instances, the two chambers of the dual-chamber cartridge may be configured to allow mixing between the two or more components prior to and / or during dispensing into the human or animal body. For example, the two chambers may be configured such that they are in fluid communication with each other (e.g., by way of a conduit between the two chambers) and allow mixing of the two components when desired by a user prior to dispensing. Alternatively or in addition, the two chambers may be configured to allow mixing as the components are being dispensed into the human or animal body.

[0089] The drugs or medicaments contained in the drug delivery devices as described herein can be used for the treatment and / or prophylaxis of many different types of medical disorders. Examples of disorders include, e.g., diabetes mellitus or complications associated with diabetes mellitus such as diabetic retinopathy, thromboembolism disorders such as deep vein or pulmonary thromboembolism. Further examples of disorders are acute coronary syndrome (ACS), angina, myocardial infarction, cancer, macular degeneration, inflammation, hay fever, atherosclerosis and / or rheumatoid arthritis. Examples of APIs and drugs are those as described in handbooks such as Rote Liste 2014, for example, without limitation, main groups 12 (anti-diabetic drugs) or 86 (oncology drugs), and Merck Index, 15th -edition.

[0090] Examples of APIs for the treatment and / or prophylaxis of type 1 or type 2 diabetes mellitus or complications associated with type 1 or type 2 diabetes mellitus include an insulin, e.g., human insulin, or a human insulin analogue or derivative, a glucagon-like peptide (GLP-1), GLP-1 analogues or GLP-1 receptor agonists, or an analogue or derivative thereof, a dipeptidyl peptidase-4 (DPP4) inhibitor, or a pharmaceutically acceptable salt or solvate thereof, or any mixture thereof. As used herein, the terms “analogue” and “derivative” refers to a polypeptide which has a molecular structure which formally can be derived from the structure of a naturally occurring peptide, for example that of human insulin, by deleting and / or exchanging at least one amino acid residue occurring in the naturally occurring peptide and / or by adding at least one amino acid residue. The added and / or exchanged amino acid residue can either be codable amino acid residues or other naturally occurring residues or purely synthetic amino acid residues. Insulin analogues are also referred to as "insulin receptor ligands". In particular, the term ..derivative” refers to a polypeptide which has a molecular structure which formally can be derived from the structure of a naturally occurring peptide, for example that of human insulin, in which one or more organic substituent (e.g., a fatty acid) is bound to one or more of the amino acids. Optionally, one or more amino acids occurring in the naturally occurring peptide may have been deleted and / or replaced by other amino acids, including non-codeable amino acids, or amino acids, including non-codeable, have been added to the naturally occurring peptide.

[0091] Examples of insulin analogues are Gly(A21), Arg(B31), Arg(B32) human insulin (insulin glargine); Lys(B3), Glu(B29) human insulin (insulin glulisine); Lys(B28), Pro(B29) human insulin (insulin lispro); Asp(B28) human insulin (insulin aspart); human insulin, wherein proline in position B28 is replaced by Asp, Lys, Leu, Vai or Ala and wherein in position B29 Lys may be replaced by Pro; Ala(B26) human insulin; Des(B28-B30) human insulin; Des(B27) human insulin and Des(B30) human insulin.

[0092] Examples of insulin derivatives are, for example, B29-N-myristoyl-des(B30) human insulin, Lys(B29) (N- tetradecanoyl)-des(B30) human insulin (insulin detemir, Levemir®); B29-N-palmitoyl-des(B30) human insulin; B29-N-myristoyl human insulin; B29-N-palmitoyl human insulin; B28-N-myristoyl LysB28ProB29 human insulin; B28-N-palmitoyl- LysB28ProB29 human insulin; B30-N-myristoyl-ThrB29LysB30 human insulin; B30-N- palmitoyl- ThrB29LysB30 human insulin; B29-N-(N-palmitoyl-gamma-glutamyl)-des(B30) human insulin, B29-N-omega-carboxypentadecanoyl-gamma-L-glutamyl-des(B30) human insulin (insulin degludec, Tresiba®); B29-N-(N-lithocholyl-gamma-glutamyl)-des(B30) human insulin; B29-N-(w-carboxyheptadecanoyl)-des(B30) human insulin and B29-N-(w- carboxyheptadecanoyl) human insulin. Examples of GLP-1 , GLP-1 analogues and GLP-1 receptor agonists are, for example, Lixisenatide (Lyxumia®), Exenatide (Exendin-4, Byetta®, Bydureon®, a 39 amino acid peptide which is produced by the salivary glands of the Gila monster), Liraglutide (Victoza®), Semaglutide, Taspoglutide, Albiglutide (Syncria®), Dulaglutide (Trulicity®), rExendin-4, CJC-1134-PC, PB-1023, TTP-054, Langlenatide / HM-1 1260C (Efpeglenatide), HM-15211 , CM-3, GLP-1 Eligen, ORMD-0901 , NN-9423, NN-9709, NN- 9924, NN-9926, NN-9927, Nodexen, Viador-GLP-1 , CVX-096, ZYOG-1 , ZYD-1 , GSK- 2374697, DA-3091 , MAR-701 , MAR709, ZP-2929, ZP-3022, ZP-DI-70, TT-401 (Pegapamodtide), BHM-034. MOD-6030, CAM-2036, DA-15864, ARI-2651 , ARI-2255, Tirzepatide (LY3298176), Bamadutide (SAR425899), Exenatide-XTEN and Glucagon- Xten.

[0093] An example of an oligonucleotide is, for example: mipomersen sodium (Kynamro®), a cholesterol-reducing antisense therapeutic for the treatment of familial hypercholesterolemia or RG012 for the treatment of Alport syndrom.

[0094] Examples of DPP4 inhibitors are Linagliptin, Vildagliptin, Sitagliptin, Denagliptin, Saxagliptin, Berberine.

[0095] Examples of hormones include hypophysis hormones or hypothalamus hormones or regulatory active peptides and their antagonists, such as Gonadotropine (Follitropin, Lutropin, Choriongonadotropin, Menotropin), Somatropine (Somatropin), Desmopressin, Terlipressin, Gonadorelin, Triptorelin, Leuprorelin, Buserelin, Nafarelin, and Goserelin.

[0096] Examples of polysaccharides include a glucosaminoglycane, a hyaluronic acid, a heparin, a low molecular weight heparin or an ultra-low molecular weight heparin or a derivative thereof, or a sulphated polysaccharide, e.g. a poly-sulphated form of the above-mentioned polysaccharides, and / or a pharmaceutically acceptable salt thereof. An example of a pharmaceutically acceptable salt of a poly-sulphated low molecular weight heparin is enoxaparin sodium. An example of a hyaluronic acid derivative is Hylan G-F 20 (Synvisc®), a sodium hyaluronate.

[0097] The term “antibody”, as used herein, refers to an immunoglobulin molecule or an antigenbinding portion thereof. Examples of antigen-binding portions of immunoglobulin molecules include F(ab) and F(ab')2 fragments, which retain the ability to bind antigen. The antibody can be polyclonal, monoclonal, recombinant, chimeric, de-immunized or humanized, fully human, non-human, (e.g., murine), or single chain antibody. In some embodiments, the antibody has effector function and can fix complement. In some embodiments, the antibody has reduced or no ability to bind an Fc receptor. For example, the antibody can be an isotype or subtype, an antibody fragment or mutant, which does not support binding to an Fc receptor, e.g., it has a mutagenized or deleted Fc receptor binding region. The term antibody also includes an antigen-binding molecule based on tetravalent bispecific tandem immunoglobulins (TBTI) and / or a dual variable region antibody-like binding protein having cross-over binding region orientation (CODV).

[0098] The terms “fragment” or “antibody fragment” refer to a polypeptide derived from an antibody polypeptide molecule (e.g., an antibody heavy and / or light chain polypeptide) that does not comprise a full-length antibody polypeptide, but that still comprises at least a portion of a full-length antibody polypeptide that is capable of binding to an antigen. Antibody fragments can comprise a cleaved portion of a full length antibody polypeptide, although the term is not limited to such cleaved fragments. Antibody fragments that are useful in the present invention include, for example, Fab fragments, F(ab')2 fragments, scFv (single-chain Fv) fragments, linear antibodies, monospecific or multispecific antibody fragments such as bispecific, trispecific, tetraspecific and multispecific antibodies (e.g., diabodies, triabodies, tetrabodies), monovalent or multivalent antibody fragments such as bivalent, trivalent, tetravalent and multivalent antibodies, minibodies, chelating recombinant antibodies, tribodies or bibodies, intrabodies, nanobodies, small modular immunopharmaceuticals (SMIP), binding-domain immunoglobulin fusion proteins, camelized antibodies, and VHH containing antibodies. Additional examples of antigenbinding antibody fragments are known in the art.

[0099] The terms “Complementarity-determining region” or “CDR” refer to short polypeptide sequences within the variable region 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 within the variable region of both heavy and light chain polypeptides that are not CDR sequences, and are primarily responsible for maintaining correct positioning of the CDR sequences to permit antigen binding. Although the framework regions themselves typically do not directly participate in antigen binding, as is known in the art, certain residues within the framework regions of certain antibodies can directly participate in antigen binding or can affect the ability of one or more amino acids in CDRs to interact with antigen. Examples of antibodies are anti PCSK-9 mAb (e.g., Alirocumab), anti IL-6 mAb (e.g., Sarilumab), and anti IL-4 mAb (e.g., Dupilumab).

[0100] Pharmaceutically acceptable salts of any API described herein are also contemplated for use in a drug or medicament in a drug delivery device. Pharmaceutically acceptable salts are for example acid addition salts and basic salts.

[0101] Those of skill in the art will understand that modifications (additions and / or removals) of various components of the APIs, formulations, apparatuses, methods, systems and embodiments described herein may be made without departing from the full scope and spirit of the present invention, which encompass such modifications and any and all equivalents thereof.

[0102] An example drug delivery device may involve a needle-based injection system as described in Table 1 of section 5.2 of ISO 11608-1 :2014(E). As described in ISO 11608- 1 :2014(E), needle-based injection systems may be broadly distinguished into multi-dose container systems and single-dose (with partial or full evacuation) container systems. The container may be a replaceable container or an integrated non-replaceable container.

[0103] As further described in ISO 11608-1 :2014(E), a multi-dose container system may involve a needle-based medicament delivery device with a replaceable container. In such a system, each container holds multiple doses, the size of which may be fixed or variable (pre-set by the user). Another multi-dose container system may involve a needle-based medicament delivery device with an integrated non-replaceable container. In such a system, each container holds multiple doses, the size of which may be fixed or variable (pre-set by the user).

[0104] As further described in ISO 11608-1 :2014(E), a single-dose container system may involve a needle-based medicament delivery device with a replaceable container. In one example for such a system, each container holds a single dose, whereby the entire deliverable volume is expelled (full evacuation). In a further example, each container holds a single dose, whereby a portion of the deliverable volume is expelled (partial evacuation). As also described in ISO 11608-1 :2014(E), a single-dose container system may involve a needlebased medicament delivery device with an integrated non-replaceable container. In one example for such a system, each container holds a single dose, whereby the entire deliverable volume is expelled (full evacuation). In a further example, each container holds a single dose, whereby a portion of the deliverable volume is expelled (partial evacuation).

Claims

CLAIMS1 . A medicament delivery device (100; 200) comprising: a needle (17); a needle cover (102; 202) moveable between a covered position in which the needle cover covers the needle and an uncovered position in which the needle is exposed from the needle cover; a needle cover bias configured to provide a needle cover biasing force to bias the needle cover (102; 202) into the covered position; and a needle cover retainer (106; 206) configured to hold the needle cover in the uncovered position against the needle cover biasing force.

2. The medicament delivery device (100; 200) of Claim 1 , wherein the medicament delivery device comprises a plunger (104; 204).

3. The medicament delivery device (100; 200) of Claim 2, wherein the needle cover retainer is configured such that axial displacement of the plunger (104; 204) causes the needle cover retainer to release the needle cover so as to allow the needle cover to move from the uncovered position to the covered position under the action of the needle cover biasing force.

4. The medicament delivery device (100; 200) of Claim 2 or 3, wherein the medicament delivery device comprises a plunger release mechanism configured to release the plunger (104; 204) for dispensing medicament from the medicament delivery device, wherein the needle cover retainer (106; 206) is configured to release the needle cover (202; 206) from the uncovered position subsequent to the release of the plunger by the plunger release mechanism.

5. The medicament delivery device (100; 200) of any preceding claim, wherein the needle cover retainer (106; 206) comprises a latching member (107; 207) and a catch (108; 208), and wherein the latching member is movable from a latched position in which the latching member is configured to engage the catch when the needle cover (102; 202) is in the uncovered position so as to hold the needle cover in the uncovered position against the needle cover biasing force, to a unlatched position in which the latchingmember is disengaged from the catch to release the needle cover so as to allow the needle cover to move from the uncovered position to the covered position under the action of the needle cover biasing force.

6. The medicament delivery device (100; 200) of Claim 5 when dependent on Claim 2, wherein the needle cover retainer (106; 206) is configured such that axial displacement of the plunger (104; 204) causes the latching member (107; 207) to move from the latched position to the unlatched position.

7. The medicament delivery device (100) of Claim 5 or 6, wherein the needle cover retainer (106; 206) further comprises a blocking member (113), the blocking member being moveable from a blocking position in which the blocking member prevents the latching member (107; 207) from moving to the unlatched position, to a non-blocking position in which the blocking member does not prevent the latching member from moving from the latched position to the unlatched position.

8. The medicament delivery device (100) of Claim 7, wherein the needle cover retainer (106; 206) comprises a collar (103) rotatable about a longitudinal axis of the device, wherein the blocking member (113) is rotationally coupled to the collar such that such that rotation of the collar about the longitudinal axis of the device causes the blocking member to move from the blocking position to the non-blocking position.

9. The medicament delivery device (100; 200) of Claim 8, wherein the collar (103) is configured to convert axial displacement of the plunger (104) into rotational movement of the collar about the longitudinal axis so as to cause the blocking member (113) to move from the blocking position to the non-blocking position upon axial displacement of the plunger.

10. The medicament delivery device (100; 200) of Claim 9 when dependent on Claim 2, wherein the plunger (104; 204) comprises a plunger cam surface (1 15), and wherein the collar (103) comprises a collar cam surface (116) configured for camming engagement with the plunger cam surface (116) such that axial displacement of the plunger (104) causes the collar (103) to rotate about the longitudinal axis of the device (100; 200) so as to cause the blocking member (113) to move from the blocking position to the nonblocking position via camming engagement of the collar cam surface (1 16) with the plunger cam surface (1 15).11 . The medicament delivery device (200) of Claim 5 or 6, wherein the medicament delivery device further comprises a collar (203) rotatable about a longitudinal axis of the device, wherein the latching member (207) is rotationally coupled to the collar such that such that rotation of the collar about the longitudinal axis of the device causes the latching member to move from the latched position to the unlatched position.

12. The medicament delivery device (200) of Claim 1 1 when dependent on Claim 2, wherein the collar (203) is configured to convert axial displacement of the plunger (204) into rotational movement of the collar about the longitudinal axis so as to move the latching member (207) from the latched position to the unlatched position.

13. The medicament delivery device (200) of either Claim 1 1 or 12 when dependent on Claim 2, wherein the plunger (204) comprises a plunger cam surface (215), and wherein the collar (203) comprises a collar cam surface (216) configured for camming engagement with the plunger cam surface such that axial displacement of the plunger causes the collar to rotate about the longitudinal axis so as to cause the latching member to move from the latched position to the unlatched position via camming engagement of the collar cam surface with the plunger cam surface.

14. The medicament delivery device (200) of any preceding claim, further comprising a cartridge and a medicament in the cartridge.

15. A method of using a medicament delivery device (100; 200), the method comprising: moving a needle cover (102; 202) of the medicament delivery device from a covered position in which the needle cover covers a needle (17) of the medicament delivery device, against a needle cover biasing force provided by a needle cover bias of the medicament delivery device, to an uncovered position in which the needle is exposed from the needle cover; and holding the needle cover against the needle cover biasing force in the uncovered position by a needle cover retainer (106; 206) of the medicament delivery device.

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