Drug Delivery Component Module

Abstract

A drug delivery member module (10) for a drug delivery device is disclosed, the drug delivery member module (10) comprising a proximal shield (30), a distal shield (50) and a drug delivery member hub (70), the drug delivery member module (10) extending in an axial direction (13) from a proximal end (14) to a distal end (15) along a longitudinal axis (12). The proximal shield (30) comprises a first surface (31) facing towards the longitudinal axis (12) and a second surface (32) facing away from the longitudinal axis (12). The drug delivery member hub (70) comprises a third surface (73) facing away from the longitudinal axis (12) and the distal shield (50) comprises a fourth surface (54) facing towards the longitudinal axis. The proximal shield (30) is movable in the axial direction (13) relative to the distal shield (50) from a proximal position to a distal position.

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS The disclosure of U.S. Provisional Patent Application No. 63 / 193133, filed May 26, 2021 by SHL Medical AG, is incorporated herein by reference.

[0002] A drug delivery member module for a drug delivery device. [Background technology]

[0003] In cartridge-based drug delivery devices, such as autoinjectors, it is important that the drug delivery member (e.g., needle) is secured prior to use to avoid needle stick injuries and to maintain sterility. Cartridge-based drug delivery devices are also typically provided with a drug delivery member that is separate from the drug container, which typically means that the user must somehow attach the drug delivery member to the drug container before performing an injection. This adds an extra step, and therefore extra complexity, to device use, which is undesirable in terms of ease of use. With this in mind, the applicant has realised that improvements can be made compared to existing designs. [Prior art documents] [Patent documents]

[0004] [Patent Document 1] PCT / EP2021 / 084082 Summary of the Invention [Means for solving the problem]

[0005] Reference should now be made to the appended claims.

[0006] An aspect is an agent delivery member module for an agent delivery device, the agent delivery member module comprising a proximal shield, a distal shield and an agent delivery member hub, the agent delivery member module extending axially along a longitudinal axis from a proximal end to a distal end, the proximal shield comprising a first surface facing towards the longitudinal axis and a second surface facing away from the longitudinal axis, the agent delivery member hub comprising a third surface facing away from the longitudinal axis, the distal shield comprising a fourth surface facing towards the longitudinal axis, the proximal shield being movable axially relative to the distal shield from a proximal position to a distal position, the agent delivery member module being configured such that during a first portion of movement of the proximal shield from the proximal position to the distal position, the first surface and the third surface contact each other, the second surface and the fourth surface contact each other, and the first surface and the third surface is greater than the friction between the second and fourth surfaces, and during a first portion of the movement of the proximal shield from the proximal position to the distal position, the drug delivery member module is arranged such that during a subsequent portion of the movement of the proximal shield from the proximal position to the distal position (after the first portion), the first and third surfaces contact each other and the second and fourth surfaces are spaced apart from each other (typically in the axial direction), the drug delivery member hub is restricted from further movement in the distal direction, and the proximal shield moves relative to both the distal shield and the drug delivery member hub in the distal direction during the subsequent portion of the movement of the proximal shield from the proximal position to the distal position. When used, this causes the drug delivery member to first pierce the cartridge and then subsequently pierce the injection site.

[0007] Optionally, the first surface and the second surface are both on a protrusion. Optionally, the protrusion is compressible. Optionally, the protrusion is on a tab of the proximal shield. Optionally, the tab is at a distal end of the proximal shield. Optionally, the third surface comprises a protrusion. This can increase friction between the first surface and the third surface. Optionally, the protrusion is a ridge extending circumferentially about the longitudinal axis. Optionally, the third surface comprises a plurality of protrusions spaced axially from one another. Optionally, the plurality of protrusions are ridges extending circumferentially about the longitudinal axis.

[0008] Optionally, the proximal shield is at least partially inside the distal shield. Optionally, the agent delivery member hub is at least partially inside the proximal shield. Optionally, the proximal shield, the distal shield, and the agent delivery member hub are coaxial. Optionally, the proximal shield is telescopically disposed inside the distal shield.

[0009] Optionally, one or more of the proximal and distal shields comprise a seal that is pierced by the agent delivery member during movement of the proximal shield relative to the distal shield.

[0010] Optionally, the proximal shield is tubular. Optionally, the proximal shield is cylindrical. Optionally, the distal shield is tubular. Optionally, the distal shield is cylindrical. Optionally, the needle hub is cylindrical. Optionally, the proximal shield is closer to the proximal end of the needle module than the distal shield.

[0011] Optionally, the needle hub comprises a drug delivery member. Optionally, the drug delivery member is a needle.

[0012] Optionally, the proximal shield is axially movable relative to the distal shield from an initial position to a proximal position, where in the initial position the first surface and the third surface contact each other and the second surface and the fourth surface are spaced apart from each other, and the drug delivery member module is positioned such that when the drug delivery member module moves from the initial position to the proximal position, the proximal shield and the drug delivery member hub move in the distal direction relative to the distal shield.

[0013] Optionally, the distal shield has a fifth surface, the fifth surface facing in a proximal direction, and the agent delivery member hub has a sixth surface, the sixth surface facing in a distal direction, the fifth surface positioned to contact the sixth surface during a subsequent portion of the movement stroke such that the agent delivery member hub is restricted from further movement in the distal direction during the subsequent portion of the movement stroke.

[0014] An embodiment relates to a subassembly of a medication delivery device comprising a cartridge and any medication delivery member module as previously described. Optionally, the cartridge comprises a fifth surface, the fifth surface facing a proximal direction, and the medication delivery member hub comprises a sixth surface, the sixth surface facing a distal direction, the fifth surface arranged to contact the sixth surface during a subsequent portion of the movement stroke such that the medication delivery member hub is restricted from further movement in the distal direction during the subsequent portion of the movement stroke.

[0015] An aspect relates to a cartridge assembly for attachment to a power pack of a drug delivery device, the cartridge assembly comprising any of the drug delivery member modules described above or any of the subassemblies described above.

[0016] An aspect relates to a drug delivery device comprising any drug delivery member module as described above, any subassembly as described above, or any cartridge assembly as described above. Optionally, the drug delivery device is an automatic injection device.

[0017] An aspect relates to a method of actuating a needle module of a medication delivery device such that a distal end of the needle pierces a cartridge and a proximal end of the needle pierces an injection site, the method comprising the following steps in the following order: pushing a proximal shield and a needle hub with a needle against the distal shield in a distal direction, where the proximal shield and the needle hub are held together by friction between the proximal shield and the needle hub; and pushing the proximal shield in a distal direction against the distal shield and the needle hub, with the friction between the proximal shield and the needle hub being overcome by engagement of the needle hub with the distal shield or by engagement of the needle hub with other medication delivery device components.

[0018] Embodiments of the present disclosure will now be described, by way of example only, with reference to the accompanying drawings in which: [Brief description of the drawings]

[0019] [Figure 1] FIG. 1 is a perspective view of a needle module with parts of the module shown in transparency (dotted lines). [Diagram 2] FIG. 2 is a perspective cross-sectional view of the proximal shield of FIG. 1. [Diagram 3] FIG. 2 is a perspective view of the needle hub of FIG. [Figure 4] FIG. 2 is a perspective cross-sectional view of a portion of the distal shield of FIG. 1. [Diagram 5] FIG. 2 is a cross-sectional view of the needle module of FIG. 1 prior to use. [Figure 6] FIG. 2 is a cross-sectional view of the needle module of FIG. 1 in use. [Figure 7] FIG. 2 is a cross-sectional view of the needle module of FIG. 1 in use. [Figure 8] FIG. 13 is a diagram of another needle module. [Figure 9] FIG. 13 is a diagram of another needle module. [Figure 10] FIG. 13 is a diagram of another needle module. [Figure 11] FIG. 13 is a diagram of another needle module. [Figure 12] FIG. 13 is a diagram of another needle module. [Figure 13] FIG. 13 is a diagram of another needle module. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0020] As an integrated needle module for a cartridge-based drug cassette, the concept described herein details how to switch the needle cover compression stroke into two different sub-steps in sequence, namely, attaching the needle to the cartridge and then subsequently inserting the needle into the injection site.

[0021] Generally, the needle cover can be used to activate the device and sequentially control the needle piercing the cartridge septum and injection site. Continuous control is provided by the arrangement of tabs on the front shield (proximal shield), embossed features on the needle hub, and inwardly projecting ridges on the rear shield (distal shield). A possible advantage of this is that only the front shield, rear shield, and needle hub require a sterilization step.

[0022] A first example of a drug delivery member module is a needle module 10 as shown in Fig. 1. The needle module 10 comprises a proximal shield (or front shield or first shield) 30, a distal shield (or back shield or second shield) 50, and a needle hub 70. The needle hub 70 comprises a needle 72. A portion of a cartridge 90 is also shown for reference. The needle hub 70 extends along a longitudinal axis 12 in an axial direction 13 from a proximal end 14 to a distal end 15. For this situation, a circumferential direction 16 with respect to the axis 12 and a radial direction 17 with respect to the axis 12 are also shown.

[0023] As shown in Figure 2, the proximal shield 30 includes a first surface 31 that faces toward the axis and a second surface 32 that faces away from the axis. As shown in Figure 3, the needle hub 70 includes a third surface 73 that faces away from the axis. As shown in Figure 4, the distal shield 50 includes a fourth surface 54 that faces toward the axis.

[0024] Proximal shield 30 is movable in axial direction 13 relative to distal shield 50 from a proximal position to a distal position, as will be described in more detail below with reference to FIGS.

[0025] The needle module is positioned such that during a first portion of the movement of the proximal shield from the proximal position to the distal position, the first surface 31 and the third surface 73 contact each other, the second surface 32 and the fourth surface 54 contact each other, and the friction between the first surface 31 and the third surface 73 is greater than the friction between the second surface 32 and the fourth surface 54. The result of this is that the needle hub 70 moves with the proximal shield 30 during the first portion of the movement from the proximal position to the distal position.

[0026] The needle module is also positioned such that during the subsequent portion of the proximal shield's movement from the first position to the second position, the first surface 31 and the third surface 73 contact each other and the second surface 32 and the fourth surface 54 are spaced apart from each other in the axial direction 13, and the needle hub 70 is restricted from further movement in the distal direction. The result of this is that the proximal shield 30 moves in the distal direction relative to both the distal shield 50 and the needle hub 70 during the subsequent portion of the movement from the proximal position to the distal position.

[0027] The structures of the proximal shield 30, the distal shield 50, and the needle hub 70 will now be described in more detail with reference to Figures 2-4. Figure 2 shows the proximal shield 30. Specifically, the proximal shield 30 comprises a first surface 31 facing towards the axis 12 and a second surface 32 facing away from the axis 12. The proximal shield is tubular (more specifically, cylindrical) with a closed proximal end and an open distal end. The proximal end comprises an optional seal 34, which may be pierced by a needle 72. Alternatively, a hole in the proximal end may be provided in the place of the seal 34 in a manner similar to the hole 56 in the distal shield (see Figure 4), which may aid in sterility through the provision of a seal.

[0028] At the distal end of the proximal shield, a number of tabs 36 (four in this case, but one, two, or more may be provided) are circumferentially spaced around the open distal end. Each tab 36 comprises a protrusion comprising a first surface 31 and a second surface 32. Each tab is at least partially made from a compressible material, such as rubber or thermoplastic elastomer (TPF). In this example, the first surface 31 is further away from the axial direction than the outer surface of the remainder of the proximal shield 30 due to the protrusion. In this example, the second surface 32 is closer to the axis than the inner surface of the remainder of the proximal shield 30 due to the protrusion (and thus closer to the surface than the cylindrical portion of the proximal shield 30). Optional recesses 38 are also provided on the inner surface of the proximal shield adjacent to the tabs 36, which may aid in bending the tabs. Bending the tab is optional, but can help the proximal shield 30 slide over the needle hub 70 during the subsequent portion of the proximal shield's movement from the first position to the second position. Alternatively, the tab may be a flexible arm.

[0029] 3 illustrates a needle hub 70. Specifically, the needle hub 70 includes a third surface 73 facing away from the axis. The third surface includes a plurality of protrusions 74. The needle hub 70 includes a base 71 and a needle 72. The needle 72 includes a proximal portion 78 and a distal portion 79. The proximal portion 78 is designed to pierce an injection site to deliver a medication. The distal portion is designed to pierce a cartridge to access a medication in the cartridge.

[0030] 4 shows the distal shield 50. In particular, the distal shield 50 comprises a fourth surface 54 facing towards the axis. The distal shield is tubular (more specifically, cylindrical) with a partially closed distal end and an open proximal end. A wall with a fifth surface 55 partially closes the distal end, away from a hole 56. The hole can optionally be closed by a seal, which will be pierced by the distal end of a needle during use. A number of projections 58 are provided (four in this case, but one, two or more may be provided, depending for example on the number of tabs 36), each projection 58 comprising the fourth surface 54.

[0031] The distal shield 50 also includes a recess 59 at the distal end of the distal shield 50. The recess is formed by a portion of the cylindrical wall of the distal shield 50 and the wall that includes the fifth surface 55. The recess is optional, but may be beneficial to guide placement of the cartridge and / or to support the cartridge during assembly of the drug delivery device and / or to support the cartridge in the completed drug delivery device.

[0032] The relative movement of the components of the needle module 10 during use of a drug delivery device comprising the module will now be described using Figures 5 to 7. The proximal shield is movable from an optional initial position (Figure 5) to a proximal position, a distal position and a final position. Figure 6 shows positions between the proximal and distal positions and Figure 7 shows positions between the distal and final positions.

[0033] An optional initial position is shown in Figure 5, where the first surface 31 and the third surface 73 are in contact with each other, the second surface 32 and the fourth surface 54 are spaced apart from each other, and the fifth surface 55 and the sixth surface 76 are spaced apart from each other. In this position, the compressible material of the tab is not compressed (or is partially compressed) between the third surface 73 and the fourth surface 54, which may provide the stored product in an uncompressed (or less compressed) state, thereby extending the shelf life. This initial position is optional, and the needle module 10 may be provided directly in the proximal position, particularly in examples that do not use a compressed material (as described below).

[0034] When a drug delivery device is prepared for use, various steps may be taken, including rotating parts, removing caps and / or other parts, and / or pressing a button. It is contemplated that the ideas described herein may be particularly useful in devices provided with a needle guard that is pushed distally relative to the housing of the device to expose the needle so that it can be inserted into the injection site and to actuate drug delivery. Thus, although the distally moving needle guard may provide the force required to push the proximal shield distally against the distal shield (with the movement of the distal shield being axially restricted relative to the housing of the device), the force may alternatively be provided in other ways, such as by a user prior to use of the device.

[0035] When the proximal shield is pushed distally relative to the distal shield, the friction between the first surface 31 and the third surface 73 causes the needle hub 70 and the proximal shield 30 to move together, so the proximal shield will move distally with the needle hub. This movement results in the second surface 32 and the fourth surface 54 coming into contact. This position is the proximal position, which may also be the position in the completed drug delivery device as described above, since the initial position is optional. Because the friction between the first surface 31 and the third surface 73 is greater than the friction between the second surface 32 and the fourth surface 54, the needle hub 70 and the proximal shield 30 will (continue to) move together in the distal direction relative to the distal shield 50, thereby reaching the position shown in FIG. 6.

[0036] As the needle hub 70 and proximal shield 30 continue to move together in the distal direction relative to the distal shield 50, the proximal shield reaches a position where the second surface 32 and the fourth surface 54 are no longer in contact (i.e., spaced apart). The needle hub 70 and proximal shield 30 continue to move together in the distal direction relative to the distal shield 50 due to the contact, creating friction between the first surface 31 and the third surface 73.

[0037] The fifth surface 55 and the sixth surface 76 then contact one another and provide greater resistance to continued distal movement of the needle hub relative to the distal shield than the friction between the first surface 31 and the third surface 73. By the time the fifth surface 55 and the sixth surface 76 contact one another, the needle 72 has pierced the cartridge.

[0038] Optionally, the fifth surface 55 and the sixth surface 76 contact each other while the second surface 32 and the fourth surface 54 are still in contact, which can increase the resistance of the proximal shield to moving relative to the distal shield in the distal direction, which may be disadvantageous in some cases.

[0039] Continued movement of the proximal shield 30 in the distal direction relative to the distal shield 50, due to the resistance provided by the contacting fifth surface 55 and sixth surface 76, results in movement of the proximal shield 30 in the distal direction relative to both the distal shield 50 and the needle hub 70. This results in the needle 72 piercing the seal 34, as shown in FIG.

[0040] In the final position, the needle extends out of the proximal end of the proximal shield and the needle extends out of the distal end of the distal shield. As a result, the needle can pierce the injection site at the proximal end of the needle and can pierce the cartridge at the distal end of the needle. In the final position, the proximal shield 30 is at its most distal position relative to the distal shield 50 and the needle hub is also at its most distal position relative to the distal shield 50. The needle module is also typically at its smallest axial length (and is typically at its greatest axial length in the assembled drug delivery device).

[0041] It is contemplated that the needle modules described herein are primarily used with drug delivery devices involving needle-free containers such as cartridges. These devices may be single use or multiple use. The drug delivery device may be provided as a single combined unit that cannot be disassembled by the user, or may be two or more parts that need to be assembled together before the user uses the drug delivery device. The needle modules used herein may be used in drug delivery devices or in cartridge assemblies for attachment to a power pack of the drug delivery device. The drug delivery device may be, for example, an autoinjector. Examples of devices in which the needle modules described herein may be used are provided in PCT / EP2021 / 084082, which is incorporated herein by reference.

[0042] Although the concepts described herein are primarily focused on needle-based injection, they can be used with drug delivery members other than needles, such as jet injectors.

[0043] From a technical standpoint, it is also feasible to rotate the entire needle module 180 degrees within the drug delivery device so that the proximal shield is at the distal end, so that the needle first penetrates the injection site and then subsequently penetrates the cartridge, instead of vice versa.

[0044] Typically, the proximal shield, the distal shield, and the drug delivery member hub are coaxial. Various adjustments can be made to the specific shapes and characteristics of the components of the needle module, and some example adjustments are described here. Although the proximal shield 30 is shown as tubular (and cylindrical), the shape can be varied, especially when sterility of the needle module is not required. Similarly, although the distal shield 50 is shown as tubular (and cylindrical), the shape can be varied, especially when sterility of the needle module is not required.

[0045] The proximal shield 30 is shown telescopically positioned inside the distal shield 50. Optionally, the proximal shield 30 and the distal shield 50 are rotationally constrained relative to one another, for example, by a groove on one of the proximal and distal shields and a ridge on the other of the proximal and distal shields. Similarly, the proximal shield and the needle hub are optionally rotationally constrained relative to one another, for example, by a groove on one of the proximal and distal shields and a ridge on the other of the proximal and distal shields. The proximal and distal shields can be two nested cylinders without rotational constraints, and in one embodiment, the contact surfaces, such as the second surface 32 and the fourth surface 54, extend entirely around the axis, meaning that the rotational position of the components relative to one another is not important. Similarly, the proximal shield and needle hub can be two nested cylinders with no rotational restrictions, and in one embodiment the contacting surfaces such as first surface 31 and third surface 73 extend entirely around the axis, meaning that the rotational position of the components relative to each other is not important.

[0046] Both the second surface 32 and the fourth surface 54 are shown as projecting beyond the surface of the respective shield 30, 50, with the second surface 32 projecting from the outer surface of the proximal shield 30 away from the axis and the fourth surface 54 projecting from the inner surface of the distal shield 50 towards the axis. Alternatively, only one of the second surface 32 and the fourth surface 54 is on the protrusion. Alternatively, neither the second surface 32 nor the fourth surface 54 is on the protrusion, which can be achieved, for example, by providing material at the second surface 32 and / or the fourth surface 54 with greater friction than at the adjacent regions of the outer / inner surfaces. Similarly, providing the first surface 31 on the protrusion is optional.

[0047] The various features of the needle module have four-fold symmetry about the axis, i.e., four individual features are provided (e.g., first surface 31, tab 36 of proximal shield 30, and protrusion 58 of distal shield 50). Alternatively, one, two, or more of each feature may be provided.

[0048] Tab 36 is described as compressible. This is optional as the same effect can be provided with a non-compressible tab, however compressibility can help vary friction and aid in allowing tab 36 to pass protrusion 74 (this can be accomplished instead by bending of tab 36 as opposed to being non-compressible, for example, by providing tab 36 with a flexible arm or by providing optional recess 38 adjacent tab 36 to make bending of the tab itself easier relative to the rest of the proximal shield 30).

[0049] The fifth surface 55 and the wall comprising the fifth surface 55 are optional, and the sixth surface 76 may alternatively abut other drug delivery device components (such as a cartridge, or a protrusion on a housing) to limit distal movement of the needle hub 70 relative to the distal shield 50. The recess 59 is also optional as the cartridge may be used to align with other drug delivery device components.

[0050] The needle hub 70 includes a base 71 shown as a cylinder, although this can vary depending, for example, on the shape of the proximal shield 30. In the depicted example, the projections 74 are circumferentially extending ridges, although other shapes may be used. The needle 72 can be a single tube extending through the base, or can include proximal and distal portions with a hole through the base connecting them. The needle may be replaced by a jet injector. The end of the needle is shown as being sharpened, although this is also optional.

[0051] FIG. 8 shows another needle module comprising a front shield 30 (proximal shield), a needle hub 70 and a rear shield 50 (distal shield).

[0052] With respect to the front shield and needle hub, the inner ridge of the front shield is positioned inside one of the slots in the needle hub to synchronize the axial rotational movement between these two components in the first stroke.

[0053] With respect to the front and rear shields, the outward projections of the front shield slide along the inner surface of the rear shield, the front and rear shields advance through the outer threads of the rear shield in a first stroke involving rotation, and pass straight through the slots in a second stroke.

[0054] With respect to the needle hub and rear shield, the threads of the needle hub slide through the inner threads of the rear shield such that when the needle hub is rotated by the front shield in the first stroke, it is also moved rearwardly into the cartridge.

[0055] Seven exemplary embodiments of the needle module are shown in FIGS. 1. The inner ridges 101 engage with slots in the needle hub to synchronize rotational movement between the front shield and the needle hub. 2. When the front shield is pushed in a rearward direction, the outward projections 102 of the front shield engage with the external threads of the rear shield so that the front shield can be rotated. 3. The slots 103 in the needle hub engage the inner ridges of the front shield so that the needle hub can be rotated with the front shield. 4. When the needle hub is rotated by the front shield, the threads 104 of the needle hub are engaged with the inner threads of the rear shield so that the needle hub can move towards the cartridge. 5. When the rear shield is pushed in the first stroke, the outer threads 105 of the rear shield rotate the front shield. 6. The internal threads 106 of the rear shield guide the insertion of the needle hub into the cartridge. 7. The straight slot 107 in the rear shield is for the front shield to move straight on the second stroke to insert the needle into the skin.

[0056] This sequence will now be described with reference to Figures 12 and 13. In the first stroke ("first part stroke"), the front shield rotates through the outer threads of the rear shield as it is pushed rearward. That rotational motion also rotates the needle hub, thus moving it rearward through the inner threads of the rear shield. In the second stroke ("second part stroke"), the front shield is pushed straight through the straight slot of the rear shield. Its inner ridge is still engaged with the needle hub, but only slides through it.

[0057] More specifically, in the first stroke, when the upper pushes the needle cover, the front shield is also pushed backwards, and its outward projection rotates the components as it slides through the outer thread of the rear shield. The rotation of the front shield is also transferred to the needle hub by its inner ridge, moving the needle hub backwards due to the connection between the inner thread of the rear shield and the thread of the needle hub. When the distal end of the needle is attached to the cartridge and the outward projection of the front shield reaches the end of the outer thread of the rear shield, this is the end of the first stroke and the beginning of the second stroke. In the second stroke, the outward projection of the front shield can slide through the straight slot of the rear shield, so no rotation is involved. Meanwhile, the inner ridge of the front shield also slides through the slot of the needle hub, so their combined features are not effective in this part of the stroke. The second stroke ends when the front shield is pushed all the way into the back shield and the needle is inserted into the skin at the injection site. The injection process can then begin.

[0058] In the present disclosure, when the term "distal direction" is used, this refers to a direction pointing away from a dose delivery site during use of the drug delivery device. When the term "distal part / end" is used, this refers to a part / end of the delivery device or a part / end of a member of the delivery device that is positioned furthest away from a dose delivery site under use of the drug delivery device. Correspondingly, when the term "proximal direction" is used, this refers to a direction pointing towards a dose delivery site during use of the drug delivery device. When the term "proximal part / end" is used, this refers to a part / end of the delivery device or a part / end of a member of the delivery device that is positioned closest to a dose delivery site under use of the drug delivery device.

[0059] Additionally, the terms "longitudinal," "longitudinally," "axially," and "axial" refer to a direction extending along a device, or a component of a device, from the proximal end to the distal end, typically in the direction of the device and / or component's longest extension.

[0060] Similarly, the terms "transverse," "transverse," and "transversely" refer to a direction generally perpendicular to the longitudinal direction.

[0061] In general, all terms used are to be interpreted according to their ordinary meaning in the art, unless expressly defined otherwise herein. All references to "elements, devices, members, components, means, etc." are to be openly interpreted as referring to at least one example of an element, device, member, component, means, etc., unless expressly stated otherwise.

[0062] The delivery devices described herein can be used for the treatment and / or prevention of one or more of many different types of diseases. Exemplary diseases include, but are not limited to, rheumatoid arthritis, inflammatory bowel disease (e.g., Crohn's disease and ulcerative colitis), hypercholesterolemia, diabetes (e.g., type 2 diabetes), psoriasis, migraine headaches, multiple sclerosis, anemia, lupus, atopic dermatitis, asthma, nasal polyps, acute hypoglycemia, obesity, anaphylaxis, and allergies. Exemplary types of drugs that can be included in the drug delivery devices described herein include, but are not limited to, antibodies, proteins, fusion proteins, peptibodies, polypeptides, pegylated proteins, protein fragments, protein analogs, protein variants, protein precursors, and / or protein derivatives. Exemplary drugs that may be included in the delivery devices described herein include etanercept (rheumatoid arthritis, inflammatory bowel disease (such as Crohn's disease and ulcerative colitis)), evolocumab (hypercholesterolemia), exenatide (type 2 diabetes), secukinumab (psoriasis), erenumab (migraine headaches), alirocumab (rheumatoid arthritis), methotrexate (amethopterin) (rheumatoid arthritis), tocilizumab (rheumatoid arthritis), interferon beta-1a (multiple sclerosis), sumatriptan (migraine headaches), adalimumab (rheumatoid arthritis), darbeposide (antimyelitis), and valproate (valproate). These include, but are not limited to (and are not limited to the examples of relevant diseases in parentheses), etin alpha (anemia), belimumab (lupus), peginterferon beta-1a' (multiple sclerosis), sarilumab (rheumatoid arthritis), semaglutide (type 2 diabetes, obesity), dupilumab (atopic dermatitis, asthma, nasal polyps, allergies), glucagon (acute hypoglycemia), epinephrine (anaphylaxis), insulin (diabetes), atropine, and vedolizumab (inflammatory bowel disease (e.g., Crohn's disease and ulcerative colitis)). Pharmaceutical formulations including any of the drugs described herein, including, but not limited to, a pharmaceutical formulation comprising a drug (or a pharma- ceutically acceptable salt of a drug) as listed herein and a pharma- ceutically acceptable carrier, are also contemplated for use in the delivery devices described herein.Pharmaceutical formulations comprising a drug (or a pharma- ceutically acceptable salt of a drug) as listed herein may contain one or more other active ingredients or may be the only active ingredient present.

[0063] Various modifications to the described embodiments are possible and will occur to those skilled in the art without departing from the invention, which is defined by the claims below.

[0064] Particular aspects are summarized by the following clauses.

[0065] 1. A drug delivery member module for a drug delivery device, the drug delivery member module comprising a proximal shield, a distal shield, and a drug delivery member hub, the drug delivery member module extending axially from a proximal end to a distal end along a longitudinal axis; the proximal shield comprises a first surface facing toward the longitudinal axis and a second surface facing away from the longitudinal axis; the medication delivery member hub has a third surface facing away from the longitudinal axis and the distal shield has a fourth surface facing toward the longitudinal axis; the proximal shield is axially movable relative to the distal shield from a proximal position to a distal position; The medication delivery member module may include, during a first portion of movement of the proximal shield from the proximal position to the distal position, the first surface and the third surface are in contact with each other, the second surface and the fourth surface are in contact with each other; The friction between the first surface and the third surface is greater than the friction between the second surface and the fourth surface; and such that during a first portion of movement of the proximal shield from the proximal position to the distal position, the medication delivery member hub moves with the proximal shield. Placed, The drug delivery member module may be configured to: during a subsequent portion (after the first portion) of the movement of the proximal shield from the proximal position to the distal position; the first surface and the third surface are in contact with each other, and the second surface and the fourth surface are spaced apart from each other (typically in an axial direction); such that the medication delivery member hub is restricted from further movement in a distal direction; and such that the proximal shield moves relative to both the distal shield and the medication delivery member hub in a distal direction during a subsequent portion of the movement of the proximal shield from the proximal position to the distal position. A drug delivery member module is disposed.

[0066] 2. The drug delivery member module of clause 1, wherein the first surface and the second surface are both on the protrusion.

[0067] 3. The drug delivery member module of clause 2, wherein the protrusions are compressible.

[0068] 4. A drug delivery member module according to clause 2 or 3, wherein the protrusion is on a tab of the proximal shield.

[0069] 5. The drug delivery member module of any of clauses 1 to 4, wherein the tab is at a distal end of the proximal shield.

[0070] 6. The drug delivery member module of any of clauses 1 to 5, wherein the third surface comprises a protrusion.

[0071] 7. The drug delivery member module of clause 6, wherein the protrusion is a ridge extending circumferentially about the longitudinal axis.

[0072] 8. The drug delivery member module of any of clauses 1 to 5, wherein the third surface comprises a plurality of protrusions spaced from one another in the axial direction.

[0073] 9. The drug delivery member module described in clause 8, wherein the plurality of protrusions are ridges extending circumferentially about the longitudinal axis.

[0074] 10. The drug delivery member module of any of clauses 1 to 9, wherein the proximal shield is at least partially inside the distal shield.

[0075] 11. The drug delivery member module of any of clauses 1 to 10, wherein the drug delivery member hub is at least partially inside the proximal shield.

[0076] 12. The drug delivery member module of any of clauses 1 to 11, wherein the proximal shield, the distal shield and the drug delivery member hub are coaxial.

[0077] 13. The drug delivery member module of any of clauses 1 to 12, wherein the proximal shield is telescopically positioned inside the distal shield.

[0078] 14. The drug delivery member module of any of clauses 1 to 13, wherein one or more of the proximal and distal shields are provided with a seal that is pierced by the drug delivery member during movement of the proximal shield relative to the distal shield.

[0079] 15. The drug delivery member module of any of clauses 1 to 14, wherein the proximal shield is tubular.

[0080] 16. The drug delivery member module of any of clauses 1 to 15, wherein the proximal shield is cylindrical.

[0081] 17. The drug delivery member module of any of clauses 1 to 16, wherein the distal shield is tubular.

[0082] 18. The drug delivery member module of any of clauses 1 to 17, wherein the distal shield is cylindrical.

[0083] 19. The drug delivery member module of any of clauses 1 to 18, wherein the needle hub is cylindrical.

[0084] 20. The drug delivery member module of any of clauses 1 to 19, wherein the proximal shield is closer to the proximal end of the needle module than the distal shield.

[0085] 21. The drug delivery member module of any of clauses 1 to 20, wherein the needle hub comprises a drug delivery member.

[0086] 22. The drug delivery member module of clause 21, wherein the drug delivery member is a needle.

[0087] 23. The proximal shield is axially movable relative to the distal shield from an initial position to a proximal position; In an initial position, the first surface and the third surface are in contact with each other and the second surface and the fourth surface are spaced apart from each other; The drug delivery member module of any of clauses 1 to 22, wherein the drug delivery member module is positioned such that the proximal shield and the drug delivery member hub move relative to the distal shield in the distal direction when the drug delivery member module moves from the initial position to the proximal position.

[0088] 24. The distal shield has a fifth surface, the fifth surface facing a proximal direction; the drug delivery member hub has a sixth surface, the sixth surface facing a distal direction; 24. The drug delivery member module of any of clauses 1 to 23, wherein the fifth surface is positioned to contact the sixth surface during a subsequent portion of the movement stroke such that the drug delivery member hub is restricted from further movement in the distal direction during the subsequent portion of the movement stroke.

[0089] 25. A subassembly of a drug delivery device comprising a cartridge and a drug delivery member module according to any of clauses 1 to 24.

[0090] 26. The cartridge has a fifth surface, the fifth surface facing a proximal direction; the medication delivery member hub has a sixth surface, the sixth surface facing a distal direction; The subassembly of clause 25 when dependent on any of clauses 1 to 23, wherein the fifth surface is arranged to contact the sixth surface during a subsequent portion of the movement stroke such that the drug delivery member hub is restricted from further movement in the distal direction during the subsequent portion of the movement stroke.

[0091] 27. A cartridge assembly for attachment to a power pack of a drug delivery device, the cartridge assembly comprising a drug delivery member module of any of clauses 1 to 24 or a subassembly of clause 25 or 26.

[0092] 28. A drug delivery device comprising a drug delivery member module of any of clauses 1 to 24, a subassembly of clause 25 or 26, or a cartridge assembly of clause 27.

[0093] 29. A drug delivery device as claimed in clause 28, wherein the drug delivery device is an automatic injection device. [Explanation of symbols]

[0094] 10 Needle Module 12 Longitudinal axis 13 Axial Direction 14 Proximal end 15 Distal end 16 Circumferential direction 17 Radial 30 Proximal shield, front shield, first shield 31 First Surface 32 Second Surface 34 Seal 36 Tabs 38 Recess 50 Distal shield, rear shield, second shield 54 The Fourth Surface 55 The Fifth Surface 56 holes 58 Protrusion 59 Recess 70 needle hub 71 Base 72 needles 73 The Third Surface 74 Protrusion 76 The Sixth Surface 78 Proximal 79 Distal 101 Medial ridge 102 Outward protrusion 103 Slots 104 Thread 105 Outer Thread 106 Internal Thread 107 Slots

Claims

1. A drug delivery member module (10) for a drug delivery device, the drug delivery member module (10) comprising a proximal shield (30), a distal shield (50) and a drug delivery member hub (70), the drug delivery member module (10) extending along a longitudinal axis (12) from a proximal end (14) to a distal end (15) in an axial direction (13); The proximal shield (30) comprises a first surface (31) facing toward the longitudinal axis (12) and a second surface (32) facing away from the longitudinal axis (12); the drug delivery member hub (70) having a third surface (73) facing away from the longitudinal axis (12), and the distal shield (50) having a fourth surface (54) facing toward the longitudinal axis; the proximal shield (30) is movable in the axial direction (13) relative to the distal shield (50) from a proximal position to a distal position; The drug delivery member module (10) is configured to, during a first portion of movement of the proximal shield (30) from the proximal position to the distal position, the first surface (31) and the third surface (73) are in contact with each other, the second surface (32) and the fourth surface (54) are in contact with each other, The friction between the first surface (31) and the third surface (73) is greater than the friction between the second surface (32) and the fourth surface (54); and such that the medication delivery member hub (70) moves with the proximal shield (30) during the first portion of the movement of the proximal shield (30) from the proximal position to the distal position. Placed, The medication delivery member module (10) during a subsequent portion of the movement of the proximal shield (30) from the proximal position to the distal position: the first surface (31) and the third surface (73) are in contact with each other, and the second surface (32) and the fourth surface (54) are spaced apart from each other; such that the medication delivery member hub (70) is restricted from further movement in a distal direction; and such that the proximal shield (30) moves relative to both the distal shield (50) and the medication delivery member hub (70) in the distal direction during the subsequent portion of the movement of the proximal shield (30) from the proximal position to the distal position. A drug delivery member module (10) is disposed.

2. 2. The drug delivery member module (10) of claim 1, wherein the first surface and the second surface are both on a protrusion (36).

3. 3. The drug delivery member module (10) of claim 2, wherein said projections (36) are compressible.

4. 4. The drug delivery member module (10) of claim 2 or 3, wherein the protrusion (36) is on a tab of the proximal shield (30).

5. 5. The drug delivery member module (10) according to any one of the preceding claims, wherein said third surface (73) is provided with a protrusion (74).

6. 6. The drug delivery member module (10) of claim 5, wherein the protrusion (74) is a ridge extending circumferentially about the longitudinal axis (12).

7. 5. The drug delivery member module (10) according to any one of claims 1 to 4, wherein the third surface comprises a plurality of protrusions (74) spaced apart from one another in the axial direction.

8. 8. The drug delivery member module (10) of claim 7, wherein the plurality of protrusions (74) are ridges extending circumferentially about the longitudinal axis (12).

9. The drug delivery member module (10) according to any one of claims 1 to 8, wherein the proximal shield (30) is arranged telescopically inside the distal shield (50).

10. the proximal shield (30) is movable in the axial direction (13) relative to the distal shield (50) from an initial position to the proximal position; In the initial position, the first surface (31) and the third surface (73) are in contact with each other, and the second surface (32) and the fourth surface (54) are spaced apart from each other; The drug delivery member module (10) of any one of claims 1 to 9, wherein the drug delivery member module (10) is arranged such that the proximal shield (30) and the drug delivery member hub (70) move in a distal direction relative to the distal shield (50) when the drug delivery member module (10) moves from the initial position to the proximal position.

11. the distal shield (50) having a fifth surface (55), the fifth surface (55) facing a proximal direction, the medication delivery member hub (70) having a sixth surface (76), the sixth surface (76) facing a distal direction; 11. The drug delivery member module (10) of claim 1, wherein the fifth surface (55) is positioned to contact the sixth surface (76) during the subsequent portion of the travel stroke such that the drug delivery member hub (70) is restricted from further movement in the distal direction during the subsequent portion of the travel stroke.

12. A subassembly of a drug delivery device comprising a cartridge and a drug delivery member module (10) according to any one of claims 1 to 11.

13. the cartridge having a fifth surface, the fifth surface facing a proximal direction, the medication delivery member hub (70) having a sixth surface (76), the sixth surface (76) facing a distal direction; A subassembly as described in claim 12 when dependent on any one of claims 1 to 10, wherein the fifth surface is arranged to contact the sixth surface (76) during the subsequent portion of the travel stroke such that the drug delivery member hub (70) is restricted from further movement in the distal direction during the subsequent portion of the travel stroke.

14. A cartridge assembly for attachment to a power pack of a drug delivery device, comprising a drug delivery member module (10) according to any one of claims 1 to 11 or a subassembly according to claim 12 or 13.

15. A drug delivery device comprising a drug delivery member module (10) according to any one of claims 1 to 11, a subassembly according to claim 12 or 13, or a cartridge assembly according to claim 14.

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