A subassembly of a medicament delivery device for needle isolation

EP4757860A1Pending Publication Date: 2026-06-17SHL MEDICAL AG

Patent Information

Authority / Receiving Office
EP · EP
Patent Type
Applications
Current Assignee / Owner
SHL MEDICAL AG
Filing Date
2024-07-25
Publication Date
2026-06-17

AI Technical Summary

Technical Problem

Current medicament delivery devices face challenges with needle isolation, particularly in preventing the needle hub from bouncing back after penetration, which can lead to failed injections.

Method used

A subassembly for a medicament delivery device featuring a needle hub with a coupling element and a retainer with a receiving element, a sealing member, and a locking interface that includes a notch and a protrusion to prevent proximal motion of the needle hub once it is in its distal position.

Benefits of technology

The locking mechanism effectively prevents the needle hub from bouncing back, ensuring the needle remains in the medicament container for successful injection, thereby reducing the risk of failed injections.

✦ Generated by Eureka AI based on patent content.

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Abstract

The present disclosure generally relates to a subassembly (8, 68, 80, 140) of a medicament delivery device (1), which medicament delivery device (1) extends from a proximal end (1a) to a distal end (1b) along a longitudinal axis (102), the subassembly (8, 68, 80, 140) being for retaining a needle (2) of the medicament delivery device (1) and comprising: a needle hub (10, 30, 60, 82, 120), a retainer (14, 44, 86, 110) configured to receive the needle hub (10, 60, 120) in a receiving element (16), and a locking interface between the needle hub (10, 30, 60, 82, 120) and the retainer (14, 44, 86, 110) that prevents a proximal motion of the needle hub (10, 30, 60, 82, 120) in the retainer (14, 44, 86, 110) once the needle hub (10, 30, 60, 82, 120) is received in the retainer (14, 44, 86, 110) so that a needle (2) reaches into the space (20) of the retainer (14, 44, 86, 110) configured to accommodate a medicament container.
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Description

[0001] A SUBASSEMBLY OF A MEDICAMENT DELIVERY DEVICE FOR

[0002] NEEDLE ISOLATION

[0003] TECHNICAL FIELD

[0004] The present disclosure generally relates to medicament delivery devices, and particularly concerns a subassembly for needle isolation.

[0005] BACKGROUND

[0006] A number of medical conditions require injections. These days, a number of different injection devices exist, including various types of pen injectors, autoinjectors and infusion devices for large volume injections. Although many of these devices have enabled major improvements in the management of a number of medical conditions, various limitations do still exist in the current technology. In considering these problems, the applicant has appreciated that various developments could be made to help improve the medicament delivery devices on the market today, for example concerning needle isolation technology and its ability to couple a needle to a medicament container.

[0007] SUMMARY

[0008] An object of the present disclosure is to provide a subassembly for a medicament delivery device, which solves, or at least mitigates problems of the prior art.

[0009] According to a first aspect of the present disclosure, there is provided a subassembly of a medicament delivery device, which medicament delivery device extends from a proximal end to a distal end along a longitudinal axis, the subassembly being for retaining a needle of the medicament delivery device and comprising: a needle hub configured to support the needle and comprising a coupling element; a retainer configured to receive the needle hub in a receiving element located in an inner space of the retainer by cooperation of the receiving element and the coupling element, the retainer further comprising a space for accommodating a medicament container that is separated from the receiving element by a sealing member configured to be penetrated by the needle; and a locking interface between the needle hub and the retainer that prevents a proximal motion of the needle hub in the retainer once the needle hub is received in the retainer so that the needle reaches into the space of the retainer configured to accommodate the medicament container, the locking interface comprising a notch in one of the needle hub and the locking interface, and a protrusion on the other one of the needle hub and the locking interface, the notch and the protrusion engaging with one another to prevent the proximal motion of the needle hub with respect to the retainer.

[0010] Embodiments of the present disclosure advantageously provides a locking mechanism that prevent the needle hub from bouncing back once the needle hub is in its distal position and the needle has penetrated the medicament container inside the retainer. The bounce back may cause the needle coming out of the medicament container and thereby a failed injection may occur. With embodiments of the present disclosure, the needle hub is prevented from such proximal motion once the needle hub is in its distal position when the medicament delivery device is activated for injection.

[0011] In the present disclosure, when the term “distal direction” is used, this refers to the direction pointing away from the dose delivery site during use of the medicament delivery device. When the term “distal part / end” is used, this refers to the part / end of the delivery device, or the parts / ends of the components thereof, which under use of the medicament delivery device is / are located furthest away from the dose delivery site. Correspondingly, when the term “proximal direction” is used, this refers to the direction pointing towards the dose delivery site during use of the medicament delivery device. When the term “proximal part / end” is used, this refers to the part / end of the delivery device, or the parts / ends of the members thereof, which under use of the medicament delivery device is / are located closest to the dose delivery site.

[0012] Further, the term “longitudinal”, “longitudinally”, “axially” or “axial” refer to a direction extending from the proximal end to the distal end, typically along the device or components thereof in the direction of the longest extension of the device and / or component.

[0013] Similarly, the terms “transverse”, “transversal” and “transversally” refer to a direction generally perpendicular to the longitudinal direction.

[0014] Further, the terms “circumference”, “circumferential”, “circumferentially” refer to a circumference or a circumferential direction 301 relative to an axis 102, typically a central axis extending in the direction of the longest extension of the device and / or component. Similarly, “radial” or “radially” refer to a direction 302 extending radially relative to the axis, and “rotation”, “rotational” and “rotationally” refer to rotation relative to the axis.

[0015] According to one embodiment, the locking interface may be at the proximal end of the retainer. This is one advantageous arrangement where the locking interface may also provide proximal stability of the needle hub. The proximal end of the retainer may also have suitable available space for the locking interface.

[0016] According to one embodiment, the locking interface may be a protrusion of the needle hub and a notch in the retainer. A protrusion-notch configuration, where the protrusion sits in the notch when in a locked position provides a simple yet robust locking interface.

[0017] According to one embodiment, the notch maybe a notch at the proximal end of the retainer, and the protrusion maybe on the needle hub. Thereby, the protrusion of the needle hub sits in the notch of the retainer to prevent the needle hub from moving proximally.

[0018] According to one embodiment, the locking interface may be annular. Thereby, the annular orientation of the needle hub with respect to the retainer has less impact on the efficiency of the locking interface.

[0019] According to one embodiment, the needle hub may comprise multiple protrusions and optionally the retainer comprises multiple respective notches. In this way, the reliability of preventing the proximal motion of the needle hub is increased.

[0020] According to one embodiment, the protrusion may be a snapper arm angled towards a proximal end of the needle hub. A snapper arm is somewhat flexible so that it bends or flexes into the notch. The tilt of the snapper arm is towards the proximal end of the needle hub into the notch of the retainer which increases the strength and reliability of the locking interface.

[0021] According to one embodiment, the angle maybe in the range of 500- 8o°, preferably in the range 550- 750.

[0022] According to one embodiment, the protrusion may comprise a proximal slope and a distal slope, where the distal slope maybe steeper than the proximal slope. The less steep proximal slope facilitates the protrusion to get into the notch, whereas the steeper distal slope reduces the risk of the protrusions falling out of the notch in the proximal direction.

[0023] According to one embodiment, the notch may comprise a proximal slope and a distal slope, where the proximal slope may be steeper than the distal slope. The steeper distal slope reduces the risk of the protrusions falling out of the notch in the proximal direction.

[0024] According to one embodiment, the notch maybe integral with the sealing member. In other words, the notch may be part of a septum that is penetrated by the needle. Advantageously, this may require less redesigning of a mould for manufacturing the retainer.

[0025] According to one embodiment, the sealing member may provide a friction fit with a protrusion at a distal end of the needle hub.

[0026] According to one embodiment, the locking interface may be a protrusion of the retainer and a notch in the needle hub. That is, it is equally applicable to have the protrusion in the retainer and the notch in the needle hub as the other way around. According to one embodiment, the retainer may comprise at least one proximally extending arm comprising the protrusion, the protrusion may extend radially inwards and is configured to abut against a proximally facing surface of the notch of the needle hub for preventing the proximal motion of the needle hub. Thus, the proximally extending arm with the protrusion catches the needle hub at the notches to advantageously prevent the proximal motion of the needle hub.

[0027] According to one embodiment, the protrusion may comprise a proximally facing inclined surface. The inclined surface facilitates a radially outwards flexing motion of the proximally extending arm as the protrusions moves into the notch.

[0028] According to one embodiment, the protrusion may be a proximally extending snapper arm that extends from the proximal end of the retainer.

[0029] According to one embodiment, wherein the snapper arm may comprise a radially inwards facing surface that may be inclined with respect to the longitudinal axis, wherein the snapper arm is configured such that an interaction between the inclined surface and a surface of the needle hub flexes the snapper arm radially outwards until the snapper arm reaches the notch where it flexes back and into the notch to rotationally lock in place.

[0030] According to one embodiment, the coupling element and the receiving element may be cooperating threads.

[0031] There is further provided a medicament delivery device comprising the subassembly according to any one of the herein disclosed embodiments.

[0032] Generally, all terms used in the claims are to be interpreted according to their ordinary meaning in the technical field, unless explicitly defined otherwise herein. All references to "a / an / the member, apparatus, component, means, etc.” are to be interpreted openly as referring to at least one instance of the member, apparatus, component, means, etc., unless explicitly stated otherwise. BRIEF DESCRIPTION OF THE DRAWINGS

[0033] The specific embodiments of the inventive concept will now be described, by way of example, with reference to the accompanying drawings, in which:

[0034] Fig. 1 is a perspective view of a medicament delivery device according to embodiments of the present disclosure;

[0035] Fig. 2 is an exploded view of a subassembly according to embodiments of the present disclosure;

[0036] Fig. 3 is a perspective view of a needle hub according to embodiments of the present disclosure;

[0037] Fig. 4 is a perspective view of a needle hub according to embodiments of the present disclosure;

[0038] Fig. 5 is a perspective view of a retainer according to embodiments of the present disclosure;

[0039] Fig 6 is a perspective view of a proximal end of an alternative embodiment of a retainer;

[0040] Fig. 7 is a cross-section of a subassembly according to embodiments of the present disclosure;

[0041] Fig. 8 is a perspective view of a needle hub according to embodiments of the present disclosure;

[0042] Fig. 9 is a cross-section of a subassembly according to embodiments of the present disclosure;

[0043] Fig. io is a perspective view of a subassembly according to embodiments of the present disclosure;

[0044] Fig. n is another perspective view of the subassembly in fig. io; Fig. 12 is a perspective view of a retainer according to an embodiment of the present disclosure;

[0045] Fig. 13 is a perspective view of a needle hub according to an embodiment of the present disclosure;

[0046] Fig. 14 is a cross-section of a subassembly according to an embodiment of the present disclosure;

[0047] Fig. 15 is a perspective view of a sealing member according to embodiments of the present disclosure;

[0048] Fig. 16 is a partially cut view of a subassembly according to embodiments of the present disclosure; and

[0049] Fig. 17 is a cross-section of the subassembly in fig. 16.

[0050] DETAILED DESCRIPTION

[0051] The inventive concept will now be described more fully hereinafter with reference to the accompanying drawings, in which exemplifying embodiments are shown. The inventive concept may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein; rather, these embodiments are provided by way of example so that this disclosure will be thorough and complete, and will fully convey the scope of the inventive concept to those skilled in the art. Like numbers refer to like members throughout the description.

[0052] Fig. 1 shows an example of a medicament delivery device 1 such as an autoinjector according to embodiments of the present disclosure. The medicament delivery device 1 is configured to expel medicament from a medicament container via a medicament delivery member such as a needle, to a user at a dose delivery site. The medicament delivery device 1 extends from a proximal end la to a distal end ib relative to the axis 102.

[0053] The medicament delivery device 1 comprises a housing 3 with a window 4.

[0054] The housing 3 has a proximal end 3a and a distal end 3b. A needle shield 6 configured to cover a needle extends out from the proximal end 3a of the housing 3.

[0055] A medicament container is placed inside the housing 3 from which medicament is expelled under the action of a spring-loaded plunger.

[0056] Fig. 2 is an exploded view of a subassembly 8 according to embodiments of the present disclosure. The subassembly 8 comprises a needle hub 10 configured to support the needle 2. For mechanical support, the needle is mounted in a through-hole 12 of the needle hub 10. When mounted, the needle protrudes out at the proximal end 13 of the needle hub. The needle hub 10 comprises a coupling element 15.

[0057] The subassembly 8 further comprises a retainer 14 configured to receive the needle hub 10 in a receiving element 16 located in an inner space 18 of the retainer 14 by cooperation of the receiving element 16 and the coupling element 15. The retainer 14 further comprises a space 20 for accommodating a medicament container. A sealing member (not shown in fig. 2) separates the receiving element 16 and the space 20 for the medicament container. The seal is penetrated by the needle 2 when the device 1 is activated for injection. Preferably, the coupling element 15 and the receiving element 16 are cooperating threads.

[0058] As will be discussed in more detail herein a locking interface between the needle hub 10 and the retainer 14 prevents a proximal motion of the needle hub 10 in the retainer 1 once the needle hub 10 is received in the retainer 14 receiving element 16. The needle hub 10 is received in the retainer 14 so that the needle 2 reaches into the space 20 of the retainer 14 configured to accommodate the medicament container and the medicament container is penetrated by the needle 2. Embodiments of the subassembly 8 with different locking interfaces will now be described in more detail.

[0059] Fig. 3 is a perspective view of a needle hub 30 according to one embodiment. In this embodiment, the needle hub 30 comprises a protrusion 32 in the form of a snapper arm as part of the locking interface. The snapper arm 32 comprises a fixed end 32a and a free end 32b. The fixed end 32a is attached to the main body of the needle hub 30. The snapper arm 32 is relatively rigid but is allowed some flexing. The free end 32b maybe displaced as the snapper arm 32 flexes. The flexibility of the snapper arm maybe greater in some directions than others, with the result that the free end 32b maybe displaced more easily in some directions than others. In particular, the free end 32b maybe displaced in directions generally parallel to the axis 102 than circumferentially around the axis 102.

[0060] The snapper arm 32 is angled or tilted an angle a towards a proximal end 30a of the needle hub 30. Furthermore, in this embodiment, multiple protrusions, in this case two snapper arms 32 are included on opposite sides of the needle hub 30. That is, the two snapper arms 32 are symmetrically arranged about the longitudinal axis 102 (which is e.g. along the length of the needle 2).

[0061] The coupling element 15 is here shown as a thread around the outer face of the needle hub 30. In the illustrated embodiment, the thread is a channel or groove in the outer face, but it could be a ridge or protrusion in other embodiments.

[0062] Fig. 4 shows another preferred embodiment of the needle hub 30. In this embodiment, the angle a between the snapper arm 32 main extension and the longitudinal axis 102 is smaller than in the embodiment shown in fig. 3. Preferably, the angle a is in the range of 500- 8o°, preferably in the range 550- 750. The smaller angle facilitates moving the needle hub into the retainer 14 but is also makes the locking between them stronger.

[0063] Fig. 5 is a perspective view of a retainer 14 according to embodiments of the present disclosure. The retainer 14 comprises a notch 40 as part of the locking interface at the proximal end 14a of the retainer 14. In this embodiment, the retainer 14 comprises two oppositely arranged notches 40 in the inner surface 42 in the proximal inner space 18 of the retainer 14. The notches 40 are made as cut-outs or trenches in the material of the retainer 14. The retainer 14 comprises a receiving element 16 in the form of an inner trench 16 06 groove 16 for example in the form of an inner thread comprising a trench or groove.

[0064] Fig. 6 is a perspective view of a proximal end 14a of an alternative embodiment of a retainer 44. As in the embodiment shown in fig. 5, a receiving element in the form of an inner trench 16 or groove is shown in the inner space 18 of the retainer 44. The receiving element may be provided as an inner thread comprising an inner trench 16. Moreover, the notch is in this embodiment an annular notch 46 that extends around the entire inner circumference of the inner space 18 of the retainer 14 at the proximal end 14a.

[0065] Fig. 7 is a cross-section of a subassembly according to embodiments of the present disclosure. Here, the needle hub 10 comprises the snapper arms 32 with the somewhat smaller angle a, preferably in the range of 550- 750. The retainer 14 comprises the notches 40 or alternatively the annular notch 44. In this position, the needle hub 10 is fully received in the retainer inner space 18 so that the coupling element 15, the outer thread, of the needle hub 10 is engaged with the receiving element 16, the inner thread, of the retainer 14.

[0066] The snapper arm 32 is engaged in the notch 40. When the needle hub 10 is inserted into the space 18 of the retainer 14, the snapper arms 32 flex a little inwards to decrease the angle a (e.g. at least a measured at the free ends 32a of the snapper arms 32). Once the snapper arms reach the notch 40, they flex outwards and land in the notch 40. The angle a of the snapper arms 32 provides for a strong locking engagement in the notches 40 which prevent the needle hub 10 from moving proximally.

[0067] With the needle hub 10 fully inserted into the retainer 14, e.g. with the snapper arms 32 located in the notches 40, the needle 2 penetrates the sealing element 50, which maybe a septum, and reaches into the space 20 where a medicament container 51 may be located. In prior art devices, the needle hub may bounce back in the proximal direction after the septum and the medicament container are penetrated which risk the needle falling out from the medicament container. With embodiments of the present disclosure, the locking interface, here embodied as a snapper arm 32 and a notch 40, the bounce back is efficiently prevented.

[0068] The snapper arms 32 maybe designed with various dimensions. For example, the thickness of the snapper arms 32 maybe in the range of 0.2-0.5 mm, such as 0.35 mm. A length of the snapper arm 32 from the fixed end 32a to the free end 32b maybe in the range of 2-2.8 mm, such as for example 2.4 mm. A width of the snapper arms maybe in the range of 0.4-0.6mm such as 0.5 mm. The max deflection of the snapper arms maybe about 0.25 mm.

[0069] The depth of the notch 40 maybe about 0.1-0.2mm, such as 0.15 mm. The profile of the free end 32a maybe curved with a radius of curvature of about o.2-0.3mm> such as 0.25 mm.

[0070] There maybe an airgap 41 of less than 0.1 mm, such as 0.05 mm between the retainer proximal end 14a and the needle hub 10.

[0071] Fig. 8 is a perspective view of a needle hub 60 according to another embodiment. In this embodiment, the protrusion is formed as a bump 62 on a shoulder 64 of the needle hub 60. The bump 62 is formed in the same rigid material as the rest of the needle hub 60.

[0072] Fig. 9 is a cross-section of the subassembly 68 comprising the needle hub 60 and a retainer 14. The notch 72 is made as an undercut about 0.5 mm from the proximal end 14a in the material of the retainer 14 and as asymmetric. Furthermore, the bump 62 has a proximal slope 74 and a distal slope 76 that are different from each other. In one preferred embodiment, the proximal slope 74 is steeper than the distal slope 76. For example, the proximal slope 74 may have a radius of curvature of about 0.25-0.3 mm such as 0.28 mm. The distal slope 76 may have a radius of curvature of about 0.17-0.23 mm such as 0.2 mm. In this way, the distal slope 76 can allow the bump 62 to get into the notch 72 buy sliding on the less steep distal slope 76 whereas the steeper proximal slope 74 prevents the bump 62 from sliding out of the notch 72. There maybe an airgap 75 of less than 0.3 mm, such as 0.2 mm between the retainer proximal end 14a and the needle hub 60.

[0073] The depth of the notch 72 is about 0.1 to 0.2 mm, such as for example 0.15 mm.

[0074] The wall thickness of the retainer at the notch 72 is thin to allow some flexing when the bump 62 moves into the notch 72 from the proximal end 14a of the retainer 14.

[0075] In addition, the notch 72 comprises a proximal slope 71 and a distal slope 73, where the proximal slope 71 is steeper than the distal slope.

[0076] Fig. 10 and fig. 11 are perspective views of another embodiment of a subassembly 80 of the present disclosure. In this embodiment, the needle hub 82 comprises the notch 84 in the proximal end 82a of the needle hub 82.

[0077] The protrusion is comprised in the retainer 86 and is a proximally extending snapper arm 88 that extends from the proximal end 90 of the retainer 86.

[0078] The snapper arm 88 comprises a radially inwards facing surface 92 that is inclined with respect to the longitudinal axis 102. The inclined surface 92 faces towards the needle hub 82. The snapper arm is flexible such that an interaction between the inclined surface 92 and a surface 94 of the needle hub 82 flexes the snapper arm 88 radially outwards. That is, as the needle hub 82 rotates with respect to the retainer 8 due to the threaded interface of the receiving element of the retainer and the coupling element of the needle hub 82, the inclined surface 92 engages with the surface 94 of the needle hub 82. This causes the snapper arm 88 to flex radially outwards.

[0079] The needle hub 82 may comprise a distally facing inclined edge surface 96 that facilitates the initial flexing of the snapper arm 88. The rotation of the needle hub 82 continues until the snapper arm 88 reaches the notch 84 where it flexes back and into the notch 84 to rotationally lock the needle hub 82 in place. That is, once the snapper arm 88 and the notch 84 are aligned, the outwards flexed snapper arm 88 falls in the notch 84 of the needle hub 82. Due to the threaded interface between the needle hub 82 and retainer 86, the needle hub cannot move proximally since the needle hub 82 is rotationally locked with respect to the retainer 86 when the snapper arm 88 has reached into the notch 84.

[0080] Fig. 12 is a perspective view of a retainer no according to an embodiment. Here, the retainer no comprises at least one proximally extending arm 112. The arms 112 extend longitudinally from the proximal end 110a of the retainer 110.

[0081] The arms 112 each comprise a protrusion 114 on a proximal end 112a that extend radially inwards. The protrusions comprise a proximally facing inclined surface 116 that is configured to engage with a surface of a needle hub 110 to flex the arms 112 radially outwards. The protrusions 114 further comprises a distally facing surface 118.

[0082] Fig. 13 is a perspective view of a needle hub 120 that is adapted for the retainer 110. The needle hub comprises oppositely arranged notches 122 formed as cut-outs in the needle hub 120. The notches 122 comprises proximally facing surfaces 124. When the needle hub 120 is inserted into the retainer no, the interaction between the proximally facing inclined surface 116 of the protrusion 114 of the retainer and a distally facing surface 126 of the needle hub 120 so that the arms 112 flex radially outwards. As the needle hub is further moved into the retainer, the protrusions 114 reaches the notches 122 whereby the arms 112 flex back radially inwards so that the protrusions 114 land in the notches 122. Engagement between the distally facing surface 118 of the protrusions 114 and the proximally facing surfaces 124 of the notches 122 prevent the needle hub 120 from moving proximally.

[0083] Fig. 14 is a cross-section of a subassembly 140 according to another embodiment. The retainer 14 comprises a notch 40 as discussed with reference to other embodiments. The needle hub 142 comprises proximally extending flexible arms 144 each comprising radially outwards extending protrusions 146 that engage with the notches 40 to proximally lock the needle hub 142 in the retainer 14. The proximally extending flexible arms 144 extend from a proximally facing shoulder surface 148 of the needle hub 142.

[0084] Fig. 15 is a perspective view of a sealing member 150 and fig. 16 is a partially cut view of a subassembly 151 according to embodiments of the present disclosure. The sealing member 150 may be a septum made from a flexible material such as rubber or a plastic material. The septum 150 comprising a sealing portion 152 arranged in the centre of the septum 150 and which serves to separate the inner space 18 and the medicament container space 20 of the retainer 14. On one side 154 of the septum 150, an edge component 156 is arranged and comprises a radially inwards facing notch 158. That is, the notch 158 is integral with the sealing member 150.

[0085] Fig. 17 is a cross-section of the subassembly 151. The needle hub 160 comprises a radially outwards extending protrusion 162 on a distal end 164 that engages in the notch 158 when the needle hub 160 is inserted into the retainer sufficiently to penetrate the septum 150 and reach the medicament container in the space 20. The sealing member 150 provides a friction fit with the protrusion 160 at the distal end 164 of the needle hub 160.

[0086] Embodiments of the present disclosure maybe applied to various medicament delivery devices. In one possible implementation, the medicament delivery maybe an autoinjector.

[0087] A medicament delivery device (such as an autoinjector) may generally include various other components. For example, a sensor unit which may recognize medicament delivery events, such as the needle inserted into an attachment portion of e.g., a pad, injection started, and medicament delivery operation ends, a memory unit which is configured to store the recorded data during the medicament delivery operation, a connectivity unit configured to transmit the stored data to a smart device or the network directly, a processing unit configured to control the entire system and processes the data before transmitting it, and / or user interface units that are configured to provide feedback to the patient, such as status LEDs, haptic, and / or audio feedback.

[0088] When the medicament delivery device is placed into the attachment portion, the sensors inside of the pad are configured to recognize the event and give feedback to the patient via haptic / visual or audio elements.

[0089] When the medicament delivery finishes, the sensors are configured to recognize the event and give feedback to the patient again. Further, the collected data is stored in the memory unit and may be transmitted to the smart device / network via the connectivity unit after the medicament delivery event finishes.

[0090] The sensor can be one of or the combination of the following: a mechanical switch, a Hall-effect sensor, an accelerometer.

[0091] The mechanical switch, hall-effect sensor, or accelerometer can be used for detection of the insertion of a needle into an injection port.

[0092] The accelerometer can be used for detecting medicament delivery events.

[0093] Possible wireless communication methods include Bluetooth and Cellular Networks.

[0094] Bluetooth connectivity requires a smart device to transmit the stored data to the network and it requires a pairing action between the pad and the smart device before being able to use the supporting pad in case of 2-way connection. But it’s a cheaper alternative and it requires less space on PCB. A i-way connection does not require pairing.

[0095] The cellular network does not require any pairing process, it can be used as a plug-n-play device, no prior setup is needed, but it’s more expensive and it requires more space on PCB. Depending on the requirements of the product any of those two technologies can be used.

[0096] Such processing units or processing circuitry may comprise a logic circuit or control unit including a microprocessor, microcontroller, programmable digital signal processor or another programmable device. The processing circuitry may also, or instead, each include an application specific integrated circuit, a programmable gate array or programmable array logic, a programmable logic device, or a digital signal processor. Where the processing circuitry includes a programmable device such as the microprocessor, microcontroller or programmable digital signal processor mentioned above, the processor may further include computer executable code that controls operation of the programmable device.

[0097] The medicament delivery devices described herein can be used for the treatment and / or prophylaxis of one or more of many different types of disorders. Exemplary disorders include, but are not limited to: rheumatoid arthritis, inflammatory bowel diseases (e.g. Crohn’s disease and ulcerative colitis), hypercholesterolaemia, diabetes (e.g. type 2 diabetes), psoriasis, migraines, multiple sclerosis, anaemia, lupus, atopic dermatitis, asthma, nasal polyps, acute hypoglycaemia, obesity, anaphylaxis and allergies. Exemplary types of drugs that could be included in the medicament delivery devices described herein include, but are not limited to, antibodies, proteins, fusion proteins, peptibodies, polypeptides, pegylated proteins, protein fragments, protein analogues, protein variants, protein precursors, and / or protein derivatives. Exemplary drugs that could be included in the medicament delivery devices described herein include, but are not limited to (with non-limiting examples of relevant disorders in brackets): etanercept (rheumatoid arthritis, inflammatory bowel diseases (e.g. Crohn’s disease and ulcerative colitis)), evolocumab (hypercholesterolaemia), exenatide (type 2 diabetes), secukinumab (psoriasis), erenumab (migraines), alirocumab (rheumatoid arthritis), methotrexate (amethopterin) (rheumatoid arthritis), tocilizumab (rheumatoid arthritis), interferon beta-ia (multiple sclerosis), sumatriptan (migraines), adalimumab (rheumatoid arthritis), darbepoetin alfa (anaemia), belimumab (lupus), peginterferon beta-ia' (multiple sclerosis), sarilumab (rheumatoid arthritis), semaglutide (type 2 diabetes, obesity), dupilumab (atopic dermatitis, asthma, nasal polyps, allergies), glucagon (acute hypoglycaemia), epinephrine (anaphylaxis), insulin (diabetes), atropine and vedolizumab (inflammatory bowel diseases (e.g. Crohn’s disease and ulcerative colitis)). Pharmaceutical formulations including, but not limited to, any drug described herein are also contemplated for use in the medicament delivery devices described herein, for example pharmaceutical formulations comprising a drug as listed herein (or a pharmaceutically acceptable salt of the drug) and a pharmaceutically acceptable carrier. Pharmaceutical formulations comprising a drug as listed herein (or a pharmaceutically acceptable salt of the drug) may include one or more other active ingredients, or may be the only active ingredient present.

[0098] The inventive concept has mainly been described above with reference to a few examples. However, as is readily appreciated by a person skilled in the art, other embodiments than the ones disclosed above are equally possible within the scope of the inventive concept, as defined by the appended claims. In particular, whilst various distinct embodiments have been described with reference to the drawings, it will be appreciated that components of these distinct embodiments may be interchanged to provide further embodiments.

Claims

CLAIMS1. A subassembly (8, 68, 8o, 140) of a medicament delivery device (1), which medicament delivery device (1) extends from a proximal end (la) to a distal end (ib) along a longitudinal axis (102), the subassembly (8, 68, 80, 140) being for retaining a needle (2) of the medicament delivery device (1) and comprising: a needle hub (10, 30, 60, 82, 120) configured to support the needle (2) and comprising a coupling element (15); a retainer (14, 44, 86, no) configured to receive the needle hub (10, 60, 120) in a receiving element (16) located in an inner space (18) of the retainer (14, 44, 86, no) by cooperation of the receiving element (16) and the coupling element (15), the retainer (14, 44, 86, 110) further comprising a space (20) for accommodating a medicament container that is separated from the receiving element (16) by a sealing member (50, 150) configured to be penetrated by the needle (2); and a locking interface between the needle hub (10, 30, 60, 82, 120) and the retainer (14, 44, 86, 110) that prevents a proximal motion of the needle hub (10, 30, 60, 82, 120) in the retainer (14, 44, 86, no) once the needle hub (10, 30, 60, 82, 120) is received in the retainer (14, 44, 86, no) so that the needle (2) reaches into the space (20) of the retainer (14, 44, 86, 110) configured to accommodate the medicament container, the locking interface comprising a notch (40, 46, 122, 158) in one of the needle hub (10, 30, 60, 82, 120) and the locking interface, and a protrusion (32, 62, 88, 114, 146, 162) on the other one of the needle hub and the locking interface, the notch (40, 46, 122, 158) and the protrusion (32, 62, 88, 114, 146, 162) engaging with one another to prevent the proximal motion of the needle hub (10, 30, 60, 82, 120) with respect to the retainer (14, 44, 86, no).

2. The subassembly (8, 68, 80, 140) according to claim 1, wherein the locking interface is at the proximal end (14a) of the retainer (14, 44, 86, 110).

3. The subassembly (8, 68, 140) according to claim 1 or claim 2, wherein the locking interface is a protrusion (32, 62, 146) of the needle hub (10, 30, 60) and a notch (40, 46, 72) in the retainer (14, 44), preferably wherein the notch is a notch at the proximal end (14a) of the retainer (14, 44) and the protrusion (32, 62, 146) is on the needle hub (10, 30, 60).

4. The subassembly according to any one of the preceding claims, wherein the locking interface is annular.

5. The subassembly (8, 68, 140, 151) according to claims 3 or claim 4, wherein the needle hub (10, 30, 60) comprises multiple protrusions (32, 62, 146) and optionally the retainer (14, 44) comprises multiple respective notches (40, 46, 72).

6. The subassembly (8) according to any one of claims 3 to 5, wherein the protrusion is a snapper arm (32) angled towards a proximal end (30a) of the needle hub (30), preferably wherein the angle is in the range of 500- 8o°, and more preferably in the range 550- 750.

7. The subassembly (68) according to any one of claims 3 to 5, wherein the protrusion (62) comprises a proximal slope (74) and a distal slope (76), where the distal slope (76) is steeper than the proximal slope (74).

8. The subassembly (68) according to any one of claims 3 to 5, wherein the notch (72) comprises a proximal slope (71) and a distal slope (73), where the proximal slope (71) is steeper than the distal slope.

9. The subassembly (151) according to claim 1, wherein the notch (158) is integral with the sealing member (150), preferably wherein the sealing member (150) provides a friction fit with a protrusion (162) at a distal end (164) of the needle hub (160).

10. The subassembly (80) according to claim 1, wherein the locking interface is a protrusion (88, 114) of the retainer (86, no) and a notch (84, 122) in the needle hub (120).

11. The subassembly according to claim io, wherein the retainer (no) comprises at least one proximally extending arm (112) comprising the protrusion (114), the protrusion (114) extends radially inwards and is configured to abut against a proximally facing surface (124) of the notch (122) of the needle hub (120) for preventing the proximal motion of the needle hub (120), preferably wherein the protrusion (114) comprises a proximally facing inclined surface (116).

12. The subassembly (80) according to claim 11, wherein the protrusion is a proximally extending snapper arm (88) that extends from the proximal end (90) of the retainer (86).

13. The subassembly (80) according to claim 12, wherein the snapper arm (88) comprises a radially inwards facing surface (92) that is inclined with respect to the longitudinal axis (102), wherein the snapper arm (88) is configured such that an interaction between the inclined surface (92) and a surface (94) of the needle hub (82) flexes the snapper arm (88) radially outwards until the snapper arm (88) reaches the notch (84) where it flexes back and into the notch (84) to rotationally lock in place.

14. The subassembly (8, 68, 80, 140, 151) according to any one of the preceding claims, wherein the coupling element (15) and the receiving element (16) are cooperating threads.

15. A medicament delivery device (1) comprising the subassembly (8, 68, 80, 140, 151) according to any one of the preceding claims.