Medicament delivery member module

Abstract

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

Description

[0001] Related application citation

[0002] The disclosure of U.S. Provisional Patent Application No. 63 / 193133, filed by SHL Medical AG on May 26, 2021, is incorporated herein by reference. Technical Field

[0003] This disclosure relates to a pharmaceutical delivery component module for a pharmaceutical delivery device. Background Technology

[0004] In cartridge-based drug delivery devices such as autoinjectors, it is important to keep the drug delivery component (e.g., the needle) secure before use to avoid needlestick injuries and maintain sterility. Furthermore, cartridge-based drug delivery devices typically have a separate drug delivery component from the drug container, meaning the user must usually attach the delivery component to the container in some way before injection. This adds an extra step and thus increases the complexity of using the device, which is undesirable in terms of ease of use. With this in mind, the applicant recognized that improvements could be made compared to existing designs. Summary of the Invention

[0005] The appended claims should now be referred to.

[0006] One aspect relates to a drug delivery component module for a drug delivery device, the drug delivery component module including a proximal shield, a distal shield, and a drug delivery component interface, the drug delivery component module extending axially from a proximal end to a distal end along a longitudinal axis, wherein the proximal shield includes a first surface facing the longitudinal axis and a second surface opposing the longitudinal axis, wherein the drug delivery component interface includes a third surface opposing the longitudinal axis, and the distal shield includes a fourth surface facing the longitudinal axis, wherein the proximal shield is axially movable from a proximal position to a distal position relative to the distal shield, wherein the drug delivery component module is arranged such that in a 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 in a second 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 in a third ... The second and fourth surfaces are in contact with each other, and the friction between the first and third surfaces is greater than the friction between the second and fourth surfaces. This causes the drug delivery component interface to move with the proximal shield during the first portion of its movement from the proximal to the distal position. The drug delivery component module is arranged such that, in the subsequent portion of the proximal shield's movement from the proximal to the distal position (after the first portion), the first and third surfaces are in contact with each other, and the second and fourth surfaces are spaced apart (generally in the axial direction), limiting further distal movement of the drug delivery component interface. Thus, during the subsequent portion of the proximal shield's movement from the proximal to the distal position, the proximal shield moves distally relative to the distal shield and the drug delivery component interface. In use, this allows the drug delivery component to first pierce the cartridge and then penetrate the injection site.

[0007] Optionally, both the first and second surfaces are on the protrusion. Optionally, the protrusion is compressible. Optionally, the protrusion is located on a tab of the proximal shield. Optionally, the tab is located at the distal end of the proximal shield. Optionally, the third surface includes a protrusion. This can increase friction between the first and third surfaces. Optionally, the protrusion is a rib extending circumferentially around a longitudinal axis. Optionally, the third surface includes a plurality of protrusions spaced apart from each other in the axial direction. Optionally, the plurality of protrusions are ribs extending circumferentially around a longitudinal axis.

[0008] Optionally, the proximal shield is at least partially located within the distal shield. Optionally, the drug delivery component interface is at least partially located within the proximal shield. Optionally, the proximal shield, the distal shield, and the drug delivery component interface are coaxial. Optionally, the proximal shield is telescopically arranged within the distal shield.

[0009] Optionally, one or more of the proximal shield and the distal shield include a seal that is punctured 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 interface is cylindrical. Optionally, the proximal shield is closer to the proximal end of the needle module than the distal shield.

[0011] Optionally, the needle interface includes a drug delivery component. Optionally, the drug delivery component is a needle.

[0012] Optionally, the proximal shield is axially movable from an initial position to a proximal position relative to the distal shield, wherein in the initial position, the first and third surfaces are in contact with each other, and the second and fourth surfaces are spaced apart from each other, and wherein the drug delivery component module is arranged such that when the drug delivery component module moves from the initial position to the proximal position, the proximal shield and the drug delivery component interface move in a distal direction relative to the distal shield.

[0013] Optionally, the distal shield includes a fifth surface facing the proximal direction, and the drug delivery member interface includes a sixth surface facing the distal direction, and the fifth surface is arranged to contact the sixth surface during a subsequent portion of the travel, thereby limiting further movement of the drug delivery member interface in the distal direction during the subsequent portion of the travel.

[0014] One aspect relates to a sub-assembly of a drug delivery device, the sub-assembly including a cartridge and any drug delivery member module as described above. Optionally, the cartridge includes a fifth surface facing a proximal direction, and the drug delivery member interface includes a sixth surface facing a distal direction, and the fifth surface is arranged to contact the sixth surface during a subsequent portion of the travel, thereby limiting further distal movement of the drug delivery member interface during the subsequent portion of the travel.

[0015] One aspect relates to a cartridge assembly for attachment to a power unit of a pharmaceutical delivery device, the cartridge assembly comprising any of the pharmaceutical delivery component modules or any of the sub-components described above.

[0016] One aspect relates to a drug delivery device comprising any of the drug delivery component modules, sub-assemblies, or cartridge assemblies described above. Optionally, the drug delivery device is an autoinjector.

[0017] One aspect relates to a method of driving a needle module of a drug delivery device such that the distal end of the needle pierces a cartridge and the proximal end of the needle penetrates an injection site, the method comprising the following steps performed in the following order: pushing a proximal shield and a needle interface including the needle in a distal direction relative to a distal shield, the proximal shield and the needle interface being held together by friction between the proximal shield and the needle interface; and pushing the proximal shield in a distal direction relative to the distal shield and the needle interface, the friction between the proximal shield and the needle interface being overcome by engagement of the needle interface with the distal shield or engagement of the needle interface with another drug delivery device component. Attached Figure Description

[0018] Embodiments of this disclosure will now be described by way of example with reference to the following accompanying drawings.

[0019] Figure 1 A perspective view of the needle module is shown, with portions of the module shown as transparent (dashed lines).

[0020] Figure 2 It shows Figure 1 A perspective cross-sectional view of the proximal shield.

[0021] Figure 3 It shows Figure 1 A perspective view of the needle interface.

[0022] Figure 4 It shows Figure 1 A perspective cross-sectional view of a portion of the distal shield.

[0023] Figures 5 to 7 It shows Figure 1 Cross-sectional views of the needle module before and during use.

[0024] Figures 8 to 13 Another needle module is shown. Detailed Implementation

[0025] As a built-in needle module for cartridge-based pillboxes, the concepts described herein detail how the needle cap compression stroke is converted into two distinct sub-steps performed sequentially: attaching the needle to the cartridge and then inserting the needle into the injection site.

[0026] Typically, a needle cap is used to trigger the device and sequentially control the needle's penetration of the cartridge diaphragm and into the injection site. This sequential control is achieved by the arrangement of tabs on the front shield (proximal shield), raised features on the needle interface, and inwardly projecting tabs on the rear shield (distal shield). One possible advantage of this arrangement is that only sterilization steps need to be performed on the front shield, rear shield, and needle interface.

[0027] The first instance of the drug delivery component module is as follows: Figure 1 The needle module 10 is shown. The needle module 10 includes a proximal shield (or front shield or first shield) 30, a distal shield (or rear shield or second shield) 50, and a needle interface 70. The needle interface 70 includes a needle 72. A portion of a cartridge 90 is also shown for reference. The needle interface 70 extends from a proximal end 14 to a distal end 15 in an axial direction 13 along a longitudinal axis 12. For contextual reference, a circumferential direction 16 and a radial direction 17 relative to axis 12 are also shown.

[0028] like Figure 2 As shown, the proximal shield 30 includes a first surface 31 facing the axis and a second surface 32 facing away from the axis. Figure 3 As shown, the needle interface 70 includes a third surface 73 opposite to the axis. (As...) Figure 4 As shown, the distal shield 50 includes a fourth surface 54 facing the axis.

[0029] The proximal shield 30 can be moved from a proximal position to a distal position relative to the distal shield 50 in the axial direction 13, as will be referred to below. Figure 5-7 To explain in more detail.

[0030] The needle module is arranged such that, during the 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 are in contact with each other, the second surface 32 and the fourth surface 54 are in contact with 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. As a result, during the first portion of the movement from the proximal position to the distal position, the needle interface 70 moves together with the proximal shield 30.

[0031] The needle module is further arranged such that, in a subsequent portion of the movement of the proximal shield from the first position to the second 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 spaced apart from each other in the axial direction 13, and further movement of the needle interface 70 in the distal direction is restricted. As a result, in a subsequent portion of the movement from the proximal position to the distal position, the proximal shield 30 moves distally relative to the distal shield 50 and the needle interface 70.

[0032] Now refer to Figures 2 to 4 The structure of the proximal shield 30, the distal shield 50, and the needle interface 70 will be described in more detail. Figure 2A proximal shield 30 is shown. Specifically, the proximal shield 30 includes a first surface 31 facing 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 includes an optional seal 34; this seal can be pierced by a needle 72. Alternatively, the hole in the proximal end can be aligned with the hole 56 of the distal shield (see...). Figure 4 A similar arrangement is made at the location of the seal 34, although providing a seal helps with sterility.

[0033] At the distal end of the proximal shield, a plurality of tabs 36 (four in this case, though one, two, or more may be provided) are circumferentially spaced around the distal end of the opening. Each tab 36 includes a protrusion comprising a first surface 31 and a second surface 32. Each tab is at least partially made of a compressible material, such as rubber or thermoplastic elastomer (TPE). In this example, due to the protrusion, the first surface 31 is further away from the axis than the outer surface of the rest of the proximal shield 30. In this example, due to the protrusion, the second surface 32 is closer to the axis than the inner surface of the rest of the proximal shield 30 (and therefore closer to the surface than the cylindrical portion of the proximal shield 30). On the inner surface of the proximal shield, optional recesses 38 are also provided adjacent to the tabs 36; these recesses facilitate allowing the tabs to bend. Allowing the tabs to bend is optional, but can help the proximal shield 30 slide over the needle interface 70 in subsequent portions of the movement of the proximal shield from the first position to the second position. Alternatively, the tab may be a flexible arm.

[0034] Figure 3 A needle interface 70 is shown. Specifically, the needle interface 70 includes a third surface 73 opposite to the axis. The third surface includes a plurality of protrusions 74. The needle interface 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 drug. The distal portion is designed to pierce a cartridge to access the drug within the cartridge.

[0035] Figure 4 The distal shield 50 is shown. Specifically, the distal shield 50 includes a fourth surface 54 facing the axis. The distal shield is tubular (more specifically cylindrical) with a partially closed distal end and an open proximal end. A wall including a fifth surface 55 partially closes the distal end, separating it from the aperture 56. The aperture may optionally be sealed with a seal that is pierced by the distal end of the needle during use. A plurality of protrusions 58 are provided (four in this case, although one, two, or more may be provided, depending, for example, on the number of tabs 36), each protrusion 58 including the fourth surface 54.

[0036] The distal shield 50 also includes a recess 59 located at the distal end of the distal shield 50. This recess is formed by a portion of the cylindrical wall of the distal shield 50 and the wall constituting the fifth surface 55. This recess is optional but may be advantageous because it guides the placement and / or supports the cartridge during assembly of the drug delivery device, and / or supports the cartridge in the completed drug delivery device.

[0037] Now will be used Figures 5 to 7 This illustrates the relative movement of the components of the needle module 10 during use of the drug delivery device, including the needle module 10. The proximal shield can move from an optional initial position ( Figure 5 Move to the proximal position, then to the distal position, and finally to the final position. Figure 6 It shows the position between the proximal and distal positions. Figure 7 The position between the distal position and the final position is shown.

[0038] Figure 5 An optional initial position is shown, in which 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 can increase the shelf life by providing the storage product in an uncompressed (or less compressed) state. This initial position is optional, and the needle module 10 can be positioned directly in a proximal position, especially in instances where compressible material is not used (as described below).

[0039] When the drug delivery device is ready for use, various steps can be performed, including rotating one part, removing the cap and / or another part, and / or pressing a button. It is conceivable that the ideas described herein may be particularly useful in devices equipped with a needle guard that is pushed distally relative to the device housing to expose the needle, allowing the needle to penetrate the injection site and also activating drug delivery. The distally moved needle guard can then provide the force required to push the proximal guard distally relative to the distal guard (the movement of the distal guard relative to the device housing is axially restricted), although this force can, of course, also be provided in another manner, for example, by the user before using the device.

[0040] As the proximal shield is pushed distally relative to the distal shield, the proximal shield moves distally together with the needle interface because the friction between the first surface 31 and the third surface 73 causes the needle interface 70 and the proximal shield 30 to move together. This movement causes the second surface 32 and the fourth surface 54 to come into contact. This point is the proximal position, which can 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 interface 70 and the proximal shield 30 will (continue to) move distally together relative to the distal shield 50, thereby reaching... Figure 6 The location shown.

[0041] As the needle interface 70 and the proximal shield 30 continue to move together in the distal direction relative to the distal shield 50, the proximal shield reaches a point where the second surface 32 and the fourth surface 54 no longer contact (i.e., are separated). Due to the contact between the first surface 31 and the third surface 73 and the resulting friction, the needle interface 70 and the proximal shield 30 continue to move together in the distal direction relative to the distal shield 50.

[0042] Next, the fifth surface 55 and the sixth surface 76 come into contact with each other, providing greater resistance than the friction between the first surface 31 and the third surface 73, thereby preventing the needle interface from moving further distally relative to the distal shield. When the fifth surface 55 and the sixth surface 76 come into contact with each other, the needle 72 has already pierced the cartridge.

[0043] Optionally, the fifth surface 55 and the sixth surface 76 are in contact with each other, while the second surface 32 and the fourth surface 54 remain in contact. Although this may increase the resistance to the movement of the proximal shield relative to the distal shield in the distal direction, which may be disadvantageous in some cases.

[0044] Due to the resistance provided by the contacting fifth surface 55 and sixth surface 76, the proximal shield 30 continues to move distally relative to the distal shield 50, causing the proximal shield 30 to move distally relative to the distal shield 50 and the needle interface 70. This causes the needle 72 to pierce the seal 34, as... Figure 7 As shown.

[0045] In the final position, the needle extends from the proximal end of the proximal shield and from the distal end of the distal shield. As a result, the needle can penetrate the injection site proximally and pierce the cartridge distally. In the final position, the proximal shield 30 is at its furthest point relative to the distal shield 50, and the needle interface is also at its furthest point relative to the distal shield 50. The needle module is also typically at its shortest length in the axial direction (while in an assembled drug delivery device, the needle module is typically at its longest length in the axial direction).

[0046] It is conceivable that the needle modules described herein are primarily used with medication delivery devices having needle-free containers (e.g., cartridges). These devices can be single-use or multi-use. Medication delivery devices can be provided as a single integrated unit that cannot be disassembled by the user, or they can be two or more parts that must be assembled together before use. The needle modules used herein can be used in medication delivery devices or in cartridge assemblies for attachment to a power unit of a medication delivery device. For example, the medication delivery device can be an autoinjector. An example of a device that can use the needle modules described herein is provided in PCT / EP2021 / 084082, which is incorporated herein by reference.

[0047] Although the ideas described herein focus primarily on needle-based injection, these ideas can also be applied to drug delivery components other than needles, such as jet injectors.

[0048] From a technical point of view, it is also feasible to rotate the entire needle module 180 degrees within the drug delivery device, so that the proximal shield is located at the distal end, causing the needle to initially pierce the injection site and then penetrate the cartridge, rather than in the reverse order.

[0049] Typically, the proximal shield, distal shield, and drug delivery component interfaces are coaxial. Various adjustments can be made to the specific shapes and features of the needle module components; some exemplary adjustments will now be described. The proximal shield 30 is shown as tubular (and cylindrical), but the shape can vary, especially when sterility of the needle module is not required. Similarly, the distal shield 50 is shown as tubular (and cylindrical), but the shape can vary, especially when sterility of the needle module is not required.

[0050] The proximal shield 30 is shown retractably arranged within the distal shield 50. Optionally, rotation of the proximal shield 30 and the distal shield 50 relative to each other is restricted, for example, by providing a groove on one of the proximal and distal shields and a rib on the other. Similarly, rotation of the proximal shield and the needle interface relative to each other is optionally restricted, for example, by providing a groove on one of the proximal shield and the needle interface and a rib on the other. The proximal and distal shields can be two nested cylinders without rotational restrictions because, in some embodiments, the contact surfaces (e.g., the second surface 32 and the fourth surface 54) extend the entire length of the axis, meaning that the rotational position of the components relative to each other is not important. Similarly, the proximal shield and the needle interface can be two nested cylinders without rotational restrictions because, in some embodiments, the contact surfaces (e.g., the first surface 31 and the third surface 73) extend the entire length of the axis, meaning that the rotational position of the components relative to each other is not important.

[0051] The second surface 32 and the fourth surface 54 are shown both protruding beyond the surfaces of their respective shields 30, 50, with the second surface 32 protruding from the outer surface of the proximal shield 30 in a direction away from the axis, and the fourth surface 54 protruding from the inner surface of the distal shield 50 toward 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; this can be achieved, for example, by providing a material with greater friction on the second surface 32 and / or the fourth surface 54 than the adjacent regions of the outer / inner surfaces. Similarly, a first surface 31 may optionally be provided on the protrusion.

[0052] The various features of the needle module have fourfold symmetry about the axis; that is, the number of each feature (e.g., the first surface 31, the tab 36 of the proximal shield 30, and the protrusion 58 of the distal shield 50) is four. Conversely, the number of each feature can also be one, two, or more.

[0053] The tab 36 is described as compressible. This is optional, as an incompressible tab can provide the same effect, but compressibility helps to alter friction and can help allow the tab 36 to pass through the protrusion 74 (this can also be achieved by bending the incompressible form of the tab 36, for example by setting the tab 36 on the flexible arm or by providing an optional recess 38 near the tab 36, thereby making the tab itself more flexible relative to the rest of the proximal shield 30).

[0054] The fifth surface 55 and the wall including the fifth surface 55 are optional, and the sixth surface 76 may also abut against another drug delivery device component (e.g., a protrusion of the cartridge or housing) to limit the distal movement of the needle interface 70 relative to the distal shield 50. The recess 59 is also optional, as other drug delivery device components can be used to align the cartridge.

[0055] The needle interface 70 includes a base 71, which is shown as cylindrical, though this can vary, for example, depending on the shape of the proximal shield 30. In the illustrated example, the protrusion 74 is a circumferentially extending rib, but other shapes can also be used. The needle 72 can be a single tube extending through the base, or it can include proximal and distal portions connected by a hole through the base. The needle can be replaced by a jet injector. The tip of the needle is shown as pointed, but this is also optional.

[0056] Figure 8 Another needle module is shown, which includes a front shield 30 (proximal shield), a needle interface 70, and a rear shield 50 (distal shield).

[0057] For the front shield and needle interface: the internal ribs of the front shield are located inside the slot of the needle interface to synchronize the axial rotational movement between the two components during the first stroke.

[0058] For the front and rear guards: the outward protrusions of the front guard slide along the inner surface of the rear guard. During the first rotational stroke, they pass through the external threads of the rear guard, and then directly through the slot during the second stroke.

[0059] For the needle interface and rear shield: the thread of the needle interface slides through the internal thread of the rear shield, so that when the needle interface is rotated by the front shield in the first stroke, it also moves backward into the cartridge.

[0060] Figures 9 to 11 Seven specific aspects of the needle module are shown:

[0061] 1. The internal rib 101 engages with the slot of the needle interface to synchronize the rotational movement between the front shield and the needle interface.

[0062] 2. The outward protrusion 102 of the front cover is coupled to the external thread of the rear cover, so that the front cover can rotate when it is pushed backward.

[0063] 3. The slot 103 of the needle interface engages with the internal rib of the front shield, so that the needle interface can rotate together with the front shield.

[0064] 4. The needle interface thread 104 is coupled to the internal thread of the rear guard, so that the needle interface can move toward the cartridge when the front guard is rotated.

[0065] 5. When the rear guard is pushed during the first stroke, the external thread 105 of the rear guard causes the front guard to rotate.

[0066] 6. Insert the 106 threaded guide needle interface of the rear protective cover into the cartridge.

[0067] 7. The straight slot 107 of the rear shield is used to allow the front shield to move linearly during the second stroke and to insert the needle into the skin.

[0068] Now refer to Figure 12 and 13 This sequence is described below. In the first stroke (“first part of the stroke”), as the front shield is pushed backward, it rotates through the external threads of the rear shield. This rotational movement of the front shield also rotates the needle interface, thus moving it backward through the internal threads of the rear shield. In the second stroke (“second part of the stroke”), the front shield is pushed directly through the flat slot of the rear shield. Its internal ribs still engage with the needle interface, but merely slide past it.

[0069] More specifically: In the first stroke, as the user presses the needle cap, the front shield is also pushed backward, and these outward protrusions of the front shield rotate the front shield as they slide over the external threads of the rear shield. This rotation of the front shield is also transmitted to the needle interface via its internal ribs, and the needle interface moves backward due to the connection between the internal threads of the rear shield and the threads of the needle interface. The first stroke ends and the second stroke begins when the distal end of the needle is attached to the cartridge and the outward protrusions of the front shield reach the end of the external threads of the rear shield. In the second stroke, the outward protrusions of the front shield can slide through the straight slot of the rear shield, thus without involving rotation. Simultaneously, the internal ribs of the front shield also slide through the slot of the needle interface, so their coupling characteristics are ineffective in this part of the stroke. The second stroke ends when the front shield is fully pushed into the rear shield, and the needle penetrates the skin at the injection site. The injection procedure can then begin.

[0070] In this disclosure, the term "distal direction" refers to the direction away from the dose delivery site during use of the drug delivery device. The term "distal portion / distal end" refers to the portion / end of the delivery device or its components that is furthest from the drug delivery site when the drug delivery device is in use. Correspondingly, the term "proximal direction" refers to the direction towards the dose delivery site during use of the drug delivery device. The term "proximal portion / proximal end" refers to the portion / end of the delivery device or its components that is closest to the drug delivery site when the drug delivery device is in use.

[0071] In addition, the terms “longitudinal,” “axial,” or their grammatical variations refer to the direction in which the device or its components extend from the proximal end to the distal end, typically along the longest extension direction of the device and / or component.

[0072] Similarly, the term "horizontal" or its grammatical variations refer to a direction roughly perpendicular to the longitudinal direction.

[0073] Generally, unless otherwise expressly defined herein, all terms used should be interpreted in accordance with their common meaning in the art. Unless otherwise expressly stated, all references to “a / the element, device, component, part, apparatus, etc.” should be interpreted in an open-ended manner as referring to at least one instance of the element, device, component, part, apparatus, etc.

[0074] The delivery devices described herein can be used to treat and / or prevent 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 II diabetes), psoriasis, migraine, multiple sclerosis, anemia, lupus, atopic dermatitis, asthma, nasal polyps, acute hypoglycemia, obesity, allergic reactions, and anaphylaxis. Exemplary types of drugs that may be included in the drug delivery devices described herein include, but are not limited to, antibodies, proteins, fusion proteins, peptides, 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, but are not limited to (non-limiting examples of related conditions in parentheses): etanercept (rheumatoid arthritis, inflammatory bowel disease (e.g., Crohn's disease and ulcerative colitis)), evolocumab (hypercholesterolemia), exenatide (type II diabetes), secukinumab (psoriasis), eleneumab (migraine), amorombumab (rheumatoid arthritis), methotrexate (rheumatoid arthritis), tocilizumab (rheumatoid arthritis), interferon beta-1a (multiple sclerosis). Sumatriptan (migraine), Adalimumab (rheumatoid arthritis), Alfadabepoetin (anemia), Belimumab (lupus), Pegylated interferon beta-1a' (multiple sclerosis), Salimycin (rheumatoid arthritis), Semagraglutide (type II diabetes, obesity), Dupilumab (atopic dermatitis, asthma, nasal polyps, allergies), Glucagon (acute hypoglycemia), Epinephrine (allergic reactions), Insulin (diabetes), Atropine and Vedolizumab (inflammatory bowel disease (e.g., Crohn's disease and ulcerative colitis)). Pharmaceutical formulations containing, but not limited to, any of the drugs described herein may also be used in the delivery devices described herein, such as pharmaceutical formulations containing the drugs listed herein (or pharmaceutically acceptable salts of such drugs) and pharmaceutically acceptable carriers. Pharmaceutical formulations containing the drugs listed herein (or pharmaceutically acceptable salts of such drugs) may contain one or more other active ingredients, or the drug may be the only active ingredient present.

[0075] Various modifications are possible to the embodiments described, and those skilled in the art will be able to conceive of such modifications without departing from the invention as defined by the appended claims.

[0076] Some aspects can be summarized by the following items.

[0077] 1. A drug delivery component module for a drug delivery device, the drug delivery component module comprising a proximal shield, a distal shield, and a drug delivery component interface, the drug delivery component module extending axially from a proximal end to a distal end along a longitudinal axis.

[0078] The proximal shield includes a first surface facing the longitudinal axis and a second surface facing away from the longitudinal axis.

[0079] The drug delivery component interface includes a third surface facing away from the longitudinal axis, while the distal shield includes a fourth surface facing the longitudinal axis.

[0080] The proximal shield is axially movable from a proximal position to a distal position relative to the distal shield.

[0081] The drug delivery component module is arranged such that in the first portion of the movement of the proximal shield from the proximal position to the distal position,

[0082] The first and third surfaces are in contact with each other, and the second and fourth surfaces are in contact with each other.

[0083] The frictional force between the first and third surfaces is greater than the frictional force between the second and fourth surfaces.

[0084] Thus, during the first portion of the movement of the proximal shield from its proximal position to its distal position, the agent delivery component interface moves together with the proximal shield.

[0085] The drug delivery component module is arranged such that in the subsequent portion (after the first portion) of the movement of the proximal shield from the proximal position to the distal position,

[0086] The first and third surfaces are in contact with each other, and the second and fourth surfaces are spaced apart from each other (typically in the axial direction).

[0087] The interface of the drug delivery component is restricted from further movement in the distal direction.

[0088] Thus, during the subsequent portion of the movement of the proximal shield from the proximal position to the distal position, the proximal shield moves distally relative to the interface between the distal shield and the agent delivery component.

[0089] 2. The drug delivery component module as described in Article 1, wherein both the first surface and the second surface are on a protrusion.

[0090] 3. The drug delivery component module as described in Section 2, wherein the protrusion is compressible.

[0091] 4. The drug delivery component module as described in Section 2 or 3, wherein the protrusion is located on the tab of the proximal shield.

[0092] 5. The drug delivery component module as described in any one of Clauses 1 to 4, wherein the tab is located at the distal end of the proximal shield.

[0093] 6. The drug delivery component module as described in any one of Articles 1 to 5, wherein the third surface includes protrusions.

[0094] 7. The drug delivery component module as described in Section 6, wherein the protrusion is a rib extending circumferentially around a longitudinal axis.

[0095] 8. The drug delivery component module as described in any one of Articles 1 to 5, wherein the third surface includes a plurality of protrusions spaced apart from each other in the axial direction.

[0096] 9. The drug delivery component module as described in Section 8, wherein the plurality of protrusions are ribs extending circumferentially around a longitudinal axis.

[0097] 10. The drug delivery component module as described in any one of Articles 1 to 9, wherein the proximal shield is at least partially located within the distal shield.

[0098] 11. The drug delivery component module as described in any one of Articles 1 to 10, wherein the drug delivery component interface is at least partially located within the proximal shield.

[0099] 12. The drug delivery component module as described in any one of Clauses 1 to 11, wherein the proximal shield, the distal shield, and the drug delivery component interface are coaxial.

[0100] 13. The drug delivery component module as described in any one of Articles 1 to 12, wherein the proximal shield is retractably arranged within the distal shield.

[0101] 14. A drug delivery component module as described in any one of Articles 1 to 13, wherein one or more of the proximal shield and the distal shield include a seal that is punctured by the drug delivery component during movement of the proximal shield relative to the distal shield.

[0102] 15. The drug delivery component module as described in any one of Articles 1 to 14, wherein the proximal shield is tubular.

[0103] 16. The drug delivery component module as described in any one of Articles 1 to 15, wherein the proximal shield is cylindrical.

[0104] 17. The drug delivery component module as described in any one of Articles 1 to 16, wherein the distal shroud is tubular.

[0105] 18. The drug delivery component module as described in any one of Articles 1 to 17, wherein the distal shroud is cylindrical.

[0106] 19. The drug delivery component module as described in any one of Articles 1 to 18, wherein the needle interface is cylindrical.

[0107] 20. The drug delivery component module as described in any one of Articles 1 to 19, wherein the proximal shield is closer to the proximal end of the needle module than the distal shield.

[0108] 21. The drug delivery component module as described in any one of Articles 1 to 20, wherein the needle interface includes a drug delivery component.

[0109] 22. The drug delivery component module as described in Section 21, wherein the drug delivery component is a needle.

[0110] 23. The drug delivery component module as described in any one of Clauses 1 to 22, wherein the proximal shield is axially movable from an initial position to a proximal position relative to the distal shield.

[0111] In the initial position, the first and third surfaces are in contact with each other, while the second and fourth surfaces are spaced apart from each other.

[0112] The drug delivery component module is arranged such that when the drug delivery component module moves from the initial position to the proximal position, the proximal shield and the drug delivery component interface move in a distal direction relative to the distal shield.

[0113] 24. A drug delivery component module as described in any one of Articles 1 to 23, wherein the distal shield includes a fifth surface facing the proximal direction, and wherein the drug delivery component interface includes a sixth surface facing the distal direction.

[0114] The fifth surface is arranged to contact the sixth surface during a subsequent portion of the travel, thereby limiting further distal movement of the agent delivery member interface during the subsequent portion of the travel.

[0115] 25. A sub-assembly of a pharmaceutical delivery device, comprising a cartridge and a pharmaceutical delivery component module as described in any one of Articles 1 to 24.

[0116] 26. A sub-assembly as described in Article 25, depending on any one of Articles 1 through 23, wherein the cartridge includes a fifth surface facing proximal, and wherein the drug delivery member interface includes a sixth surface facing distal.

[0117] The fifth surface is arranged to contact the sixth surface during a subsequent portion of the travel, thereby limiting further distal movement of the agent delivery member interface during the subsequent portion of the travel.

[0118] 27. A cartridge assembly for attachment to a power unit of a pharmaceutical delivery device, the cartridge assembly comprising a pharmaceutical delivery component module as described in any one of Articles 1 to 24 or a sub-assembly as described in Article 25 or 26.

[0119] 28. A pharmaceutical delivery device comprising a pharmaceutical delivery component module as described in any one of Articles 1 to 24, a sub-assembly as described in Article 25 or 26, or a cartridge assembly as described in Article 27.

[0120] 29. The drug delivery device as described in Section 28, wherein the drug delivery device is an autoinjector.

Claims

1. A drug delivery component module (10) for a drug delivery device, the drug delivery component module (10) comprising a proximal shield (30), a distal shield (50), and a drug delivery component interface (70), the drug delivery component module (10) extending from a proximal end (14) to a distal end (15) in an axial direction (13) along a longitudinal axis (12). The proximal shield (30) includes a first surface (31) facing the longitudinal axis (12) and a second surface (32) facing away from the longitudinal axis (12). The drug delivery component interface (70) includes a third surface (73) facing away from the longitudinal axis (12), while the distal shield (50) includes a fourth surface (54) facing the longitudinal axis. The proximal shield (30) is axially (13) movable from a proximal position to a distal position relative to the distal shield (50). The drug delivery component module (10) is arranged such that in the first part 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 in contact with each other, and The frictional force between the first surface (31) and the third surface (73) is greater than the frictional force between the second surface (32) and the fourth surface (54). Thus, during the first portion of the movement of the proximal shield (30) from the proximal position to the distal position, the agent delivery component interface (70) moves together with the proximal shield (30). The drug delivery component module (10) is arranged such that in the 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, while the second surface (32) and the fourth surface (54) are spaced apart from each other, and The interface (70) of the drug delivery component is restricted from further movement in the distal direction. Thus, during the subsequent portion of the movement of the proximal shield (30) from the proximal position to the distal position, the proximal shield (30) moves in the distal direction relative to the distal shield (50) and the agent delivery component interface (70).

2. The drug delivery component module (10) as claimed in claim 1, wherein the first surface and the second surface are both on the protrusion (36).

3. The drug delivery component module as claimed in claim 2, wherein the protrusion (36) is compressible.

4. The drug delivery component module (10) as claimed in claim 2 or 3, wherein the protrusion (36) is located on the tab of the proximal shield (30).

5. The drug delivery component module (10) according to any one of claims 1 to 3, wherein the third surface (73) includes a protrusion (74).

6. The drug delivery component module of claim 5, wherein the protrusion (74) of the third surface (73) is a rib extending circumferentially around the longitudinal axis (12).

7. The drug delivery component module (10) according to any one of claims 1 to 3, wherein the third surface includes a plurality of protrusions (74) spaced apart from each other in the axial direction.

8. The drug delivery component module (10) as claimed in claim 7, wherein the plurality of protrusions (74) are ribs extending circumferentially around a longitudinal axis (12).

9. The drug delivery component module (10) according to any one of claims 1 to 3, wherein the proximal shield (30) is retractably arranged within the distal shield (50).

10. The drug delivery component module (10) as claimed in any one of claims 1 to 3, wherein the proximal shield (30) is movable relative to the distal shield (50) in the axial direction (13) from an initial position to a proximal position. In the initial position, the first surface (31) and the third surface (73) are in contact with each other, while the second surface (32) and the fourth surface (54) are spaced apart from each other. The drug delivery component module (10) is arranged such that when the drug delivery component module (10) moves from the initial position to the proximal position, the proximal shield (30) and the drug delivery component interface (70) move in a distal direction relative to the distal shield (50).

11. The drug delivery component module (10) as claimed in any one of claims 1 to 3, wherein the distal shield (50) includes a fifth surface (55) facing the proximal direction, and wherein the drug delivery component interface (70) includes a sixth surface (76) facing the distal direction, and The fifth surface (55) is arranged to contact the sixth surface (76) during a subsequent portion of the travel, thereby limiting further distal movement of the agent delivery component interface (70) during the subsequent portion of the travel.

12. A sub-assembly of a pharmaceutical delivery device, comprising a cartridge and a pharmaceutical delivery component module (10) as claimed in any one of claims 1 to 11.

13. The sub-assembly of claim 12 as dependent on any one of claims 1 to 10, wherein the cartridge includes a fifth surface facing proximal, and wherein the drug delivery member interface (70) includes a sixth surface (76) facing distal. The fifth surface is arranged to contact the sixth surface (76) during a subsequent portion of the travel, thereby limiting further distal movement of the agent delivery component interface (70) during the subsequent portion of the travel.

14. A cartridge assembly for attachment to a power unit of a pharmaceutical delivery device, the cartridge assembly comprising a pharmaceutical delivery component module (10) as claimed in any one of claims 1 to 11 or a sub-assembly as claimed in claim 12 or 13.

15. A drug delivery device comprising a drug delivery component module (10) as claimed in any one of claims 1 to 11, a sub-assembly as claimed in claim 12 or 13, or a cartridge assembly as claimed in claim 14.

Images