Cap for medicament delivery device

Abstract

A cap (1) for a medicament delivery device comprising a delivery member shield wherein the cap (1) comprises: a body (3) having a proximal end portion (3a) and a distal end portion (3b) wherein the distal end portion (3b) has a smaller radial dimension than the proximal end portion (3a), the distal end portion (3b) has a central channel (3e) configured to receive the delivery member shield, where the distal end portion (3b) comprises a plurality of flexible first clips (5) and a plurality of second clips (7) extending radially inward into the central channel (3e), wherein each second clip (7) extends further in a proximal direction towards the proximal end portion (3a) than the first clip (5).

Description

Technical Field

[0001] The present disclosure relates generally to drug delivery devices. Background Art

[0002] A drug delivery device such as an automatic injector may include an injector including a needle covered by a needle shield prior to use. The needle shield may be covered by a front cover of the device. Prior to administration of the drug, the cover is removed from the drug delivery device. The cover may be designed to engage with the needle shield so that when the cover is removed from the drug delivery device, the cover captures the needle shield. Summary of the invention

[0003] A general object of the present disclosure is to provide a cap for a medication delivery device which solves or at least alleviates the problems of the prior art.

[0004] Therefore, according to a first aspect of the present disclosure, a cover for a drug delivery device is provided, the drug delivery device including a delivery member shield, wherein the cover comprises: a main body having a proximal end portion and a distal end portion, wherein the distal end portion has a smaller radial dimension than the proximal end portion, the distal end portion having a central channel configured to receive the delivery member shield, wherein the distal end portion comprises a plurality of flexible first clamps and a plurality of second clamps extending radially inwardly into the central channel, wherein each second clamp extends further than the first clamp in a proximal direction toward the proximal end portion.

[0005] This design enables efficient removal of the delivery member shield from a delivery member such as a needle. Specifically, the first clamp having a shorter extension in the proximal direction than the second clamp can engage with the distal end of the delivery member shield, and the second clamp extending further in the proximal direction can engage with the outer surface of the delivery member shield or any recess or window provided in the peripheral surface of the delivery member shield. Thus, when the cover is pulled off the drug delivery device, the first clamp and the second clamp provide engagement with different features of the delivery member shield.

[0006] 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 a medication delivery device. When the term "distal portion / distal end" is used, this refers to a portion / end of a medication delivery device or a portion / end of a component of a medication delivery device that is positioned furthest from a dose delivery site during use of the medication delivery device.

[0007] 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.

[0008] When the term "proximal portion / end" is used this refers to the portion / end of a medication delivery device or a portion / end of a component of a delivery device which during use of the delivery device is positioned closest to a dose delivery site.

[0009] Additionally, the terms "longitudinal," "longitudinally," "axially," and "axial" refer to a direction extending from a proximal end to a distal end, typically along a device or component thereof in the direction of longest extension of the device and / or component.

[0010] Similarly, the terms "lateral," "transverse," and "transversely" refer to a direction generally perpendicular to the longitudinal direction.

[0011] Furthermore, the terms "circumferential," "circumferential," or "circumferentially" refer to a circumferential or circumferential direction relative to an axis, which is typically a central axis extending in the direction of longest extension of a device and / or component.

[0012] Similarly, "radial" or "radially" refer to directions extending radially relative to an axis, and "rotational," "rotational," and "rotationally" refer to rotation relative to the axis.

[0013] According to one embodiment, each first clamp is semicircular in the circumferential direction of the cover.

[0014] According to one embodiment, the second clamp is pointed. This facilitates engagement with, for example, the outer surface or a recess or window provided in the outer surface of the delivery member shield.

[0015] According to one embodiment, the second clamp comprises two proximal-pointing tips. Each second clamp may thus comprise two proximal-pointing tips. This makes each tip more mechanically flexible, which may facilitate engagement of the second clamp with the delivery member shield.

[0016] According to one embodiment, the tips of each second clamp are separated by a notch.

[0017] According to one embodiment, the distal end portion comprises arms extending distally, wherein each first clamp is connected to two adjacent arms in the circumferential direction of the cover, and each second clamp is connected to two adjacent arms in the circumferential direction of the cover.

[0018] According to one embodiment, each arm is connected to a first clamp and a second clamp.

[0019] According to one embodiment, the cover is a single integral component. Thus, the cover including the first clamp and the second clamp can be a single integral component. This simplifies the assembly process of the drug delivery device because the cover itself does not need to be assembled from components.

[0020] According to one embodiment, the cover is made of plastic. Therefore, the first clamp and the second clamp may also be made of plastic.

[0021] According to one embodiment, each first clamp has a first clamp distal end and each second clamp has a second clamp distal end, wherein along the longitudinal axis direction of the cover, the first clamp distal end and the second clamp distal end are horizontal.

[0022] According to a second aspect of the present disclosure, a drug delivery device is provided, which includes: a shell; a drug container arranged in the shell, the drug container including a delivery member; a delivery member shield covering the delivery member; and a cover according to the first aspect, wherein the central channel of the distal end portion receives the delivery member shield.

[0023] According to one embodiment, the first clamp abuts the distal end of the delivery member shield.

[0024] According to one embodiment, the delivery member shroud comprises a plurality of radial shroud windows, wherein the second clamps each extend into a respective shroud window of the plurality of radial shroud windows.

[0025] The medicament delivery device may be an autoinjector.

[0026] According to a third aspect, a method for assembling a drug delivery device according to the second aspect is provided, the method comprising: a) attaching the cover to the proximal shell end of the shell, and b) arranging the drug container in the shell via the distal opening of the shell so that the delivery member shield is received by the distal end portion of the cover.

[0027] In general, unless explicitly defined otherwise herein, all terms used in the claims should be interpreted according to their ordinary meaning in the technical field. Unless explicitly stated otherwise, all references to an element, device, component, device, etc. should be openly interpreted as referring to at least one instance of an element, device, component, device, etc. BRIEF DESCRIPTION OF THE DRAWINGS

[0028] Certain embodiments of the present inventive concept will now be described, by way of example only, with reference to the accompanying drawings, in which:

[0029] Figure 1 is a perspective view of an example of a cover for a drug delivery device;

[0030] Figure 2 yes Figure 1 A longitudinal section of the cover;

[0031] Figure 3 Shows Figure 1 A perspective view of the cover and delivery member shield in FIG.

[0032] Figure 4 Shows Figure 3 a cover and a delivery member shield in the cover, wherein the delivery member shield is disposed in the cover;

[0033] Figure 5 is a perspective view of an example of a drug delivery device; and

[0034] Figure 6 Shows Figure 5 Exploded view of the drug delivery device in. DETAILED DESCRIPTION

[0035] The inventive concept will now be described more fully below with reference to the accompanying drawings, in which exemplary embodiments are shown. However, the inventive concept can be implemented in many different forms and should not be construed as being limited to the embodiments set forth herein. On the contrary, these embodiments are provided by way of example so that this disclosure will be thorough and complete, and will fully convey the scope of the inventive concept to those skilled in the art. Throughout the specification, similar reference numerals refer to similar elements.

[0036] Figure 1 An example of a cap 1 for a medication delivery device such as an autoinjector is shown.

[0037] The cap 1 comprises a main body 3. The main body 3 has a proximal end portion 3a and a distal end portion 3b.

[0038] The proximal end portion 3 a comprises an outer wall 3 c . The outer wall 3 c forms the outer surface of the cap 1 .

[0039] The body 3 includes an elongated structure 3d extending concentrically with the outer wall 3c. The elongated structure 3d can be cylindrical or substantially cylindrical. The elongated structure 3d has a proximal portion extending within the outer wall 3c. The elongated structure 3d has a distal portion defining a distal end portion 3b of the body 3. The distal end and thus the distal end portion 3b protrudes from the proximal end portion 3a and extends distally relative to the proximal end portion. The distal end portion 3b has a smaller radial dimension or radius than the proximal end portion 3a.

[0040] The distal end portion 3b is hollow. The distal end portion 3b includes a central channel 3e extending axially along the central longitudinal axis of the cap 1. The central channel 3e extends all the way to the distal end of the distal end portion 3e, which is also the distal end of the cap 1. The central channel 3e is open at the distal end of the distal end portion 3b. The central channel 3e is configured to receive a delivery member shield of a drug delivery device.

[0041] The distal end portion 3 b comprises a plurality of radially flexible first clips 5 and a plurality of radially flexible second clips 7 .

[0042] The first clamp 5 extends radially inwardly into the central channel 3e. The first clamp 5 extends in a direction towards the proximal end of the cap 1.

[0043] The first clamp 5 may be semicircular in the circumferential direction of the cover 1 .

[0044] The second clamp 7 extends radially inwardly into the central channel 3e. The second clamp 7 extends in a direction towards the proximal end of the cap 1.

[0045] The second clamps 7 may be pointed. Each second clamp 7 may include two pointed ends 7a separated by a notch 7b in the circumferential direction of the cover 1.

[0046] According to this example, each first clamp 5 faces another first clamp 5. Each second clamp 7 faces another second clamp 7.

[0047] According to this example, the first clamps 5 and the second clamps 7 are alternately arranged along the circumferential direction of the cover 1 .

[0048] The distal end portion 3b comprises a plurality of distally extending arms 9.

[0049] Each first clamp 5 is connected to two adjacent arms 9. The arms 9 connected to each first clamp 5 are arranged adjacent to each other in the circumferential direction of the cover 1.

[0050] Each second clamp 7 is connected to two adjacent arms 9. The arms 9 connected to each second clamp 7 are arranged adjacent to each other in the circumferential direction of the cover 1.

[0051] The first clamp 5 and the second clamp 7 form the distal end of the arm 9 and extend from this location in the proximal direction.

[0052] There is a radial cover window 11 between each pair of adjacent arms 9. Each radial cover window 11 may be arranged in axial alignment with a respective one of the first 5 and second 7 clamps.

[0053] Now go to Figure 2 , shows a longitudinal section of the cap 1. The first clamp 5 and the second clamp 7 define the distal ends of the distal end portion 3b of the body 3. Each first clamp 5 has a first clamp distal end 5a, and each second clamp 7 has a second clamp distal end 7c. The first clamp distal end 5a and the second clamp distal end 7c are horizontal in the axial direction along the longitudinal axis A of the cap 1.

[0054] The second clamps 7 extend further than the first clamps 5 in the distal direction towards the distal end portion 3a of the body 3. Each second clamp 7 thus has a longer axial extension than the axial extension of the first clamps 5.

[0055] Figure 3 The cap 1 and the delivery member shield 13 are shown. According to this example, the delivery member shield 13 is configured to receive a needle of an injector or a medicament container. Thus, according to this example, the delivery member shield 13 is a needle shield.

[0056] The delivery member shield 13 has a proximal end 14a and a distal end 14b.

[0057] The delivery member shield 13 includes a flexible delivery member shield 13a, a rigid delivery member shield 13b, and a rigid outer cover 13c. The flexible delivery member shield 13a is arranged at the innermost side, followed by the rigid delivery member shield 13b, followed by the rigid outer cover 13c arranged at the outermost side. For example, the flexible delivery member shield 13a can be made of an elastomeric material, and the rigid delivery member shield 13b and the rigid outer cover 13c can be made of a cross-linked polymer material.

[0058] The rigid outer cover 13 c has an outer surface provided with radial shroud windows 15 .

[0059] Figure 4 The situation is shown when the delivery member shield 13 is arranged in the central channel 3e of the cover 1 .

[0060] Each shield window 15 is axially aligned with the corresponding second clamp 7. Specifically, the tip 7a of each second clamp 7 extends into the shield window 15.

[0061] The first clamp 5 is axially distally arranged relative to the distal end 14b of the delivery member shield 13. The first clamp 5 may abut against the distal end 14b of the delivery member shield 13.

[0062] When the cap 1 is pulled off from the delivery member extending into the delivery member shield 13, the first clamp 5 engages with the distal end 14b of the delivery member shield 13, and the second clamp 7 engages with the proximal edge of a corresponding one of the shield windows 15. Thus, the delivery member shield 13 is efficiently removed from the delivery member with the cap 1.

[0063] Figure 5 An example of a medication delivery device 17 is shown.

[0064] The medicament delivery device 17 comprises a housing 19. The housing 19 has a proximal housing end 19a and a distal housing end 19b.

[0065] The medicament delivery device 17 comprises a cap 1. The cap 1 forms the forward or proximal end of the medicament delivery device 17 before it is removed. The proximal end portion 3a of the body 3 extends proximally from the proximal housing end 19a. The distal end portion 3b is received by the housing 19.

[0066] Figure 6 Shows Figure 5 It should be noted that the cap 1 can be used with a number of different drug delivery device designs, and Figures 5 and 6 The one design illustrated in FIG. 1 is described for illustrative purposes only.

[0067] The drug delivery device 17 includes a delivery member cover 21, which is arranged in the housing 19 and is configured to move between an extended position and a retracted position relative to the housing 19, in which the delivery member cover extends through an opening in the proximal housing end 19a; in the retracted position, the delivery member cover moves in a distal direction toward the distal housing end 19b.

[0068] The delivery member cover 21 is biased towards the extended position.Thus, the medicament delivery device 17 may comprise a first resilient member 23, such as a spring, configured to bias the delivery member cover 21 towards the extended position.

[0069] The delivery member cover 21 has proximally directed legs 21a, each provided with a radially inwardly extending protrusion 21b.

[0070] The medicament delivery device 17 comprises a medicament container 25 provided with a delivery member 25a. According to this example, the medicament container 25 is an injector and the delivery member 25a is a needle.

[0071] The medicament delivery device 17 further comprises a stopper 27 arranged in the medicament container 25 .

[0072] The drug delivery device 17 further includes a plunger rod 29, a second elastic member 31, a rod 33, a U-shaped bracket 35, a rotator 37 and a rear cover body 39. The components 29 to 39 form a power group that provides mechanical power for expelling the drug from the drug container 25.

[0073] The plunger rod 29 is hollow and includes a distal end opening in which a rod 33 is arranged and in which a second elastic member 31 is arranged around the rod 33. The second elastic member 31 biases the plunger rod 29 in the proximal direction.

[0074] The U-shaped bracket 35 has a proximally extending leg that is outside of and extends radially along the plunger rod 29. Its function is to provide an audible click when the dosing of the medicament has begun and / or has reached its end.

[0075] Furthermore, the plunger rod 29 has a radial recess 29 a in its outer surface.

[0076] The rear cover body 39 has a proximal opening configured to receive the plunger rod 29. The rear cover body 39 has a radially flexible arm 39a having a radially inwardly extending structure configured to engage with a corresponding one of the radial recesses 29a of the plunger rod 29. The rotator 37 is arranged around the proximal portion of the rear cover body 39 and is provided with the flexible arm 39a. The rotator 37 is initially in a first rotator position, wherein the inner surface of the rotator 37 prevents the flexible arm 39a from bending radially outward. The plunger rod 29 is therefore maintained in its initial axial position.

[0077] The rotator 37 is configured to rotate from a first rotator position to a second rotator position by cooperating with the delivery member cover 21. The rotator 37 has an outer cam surface 37a, which is configured to cooperate with a corresponding one of the radially inwardly extending protrusions 21b of the delivery member cover 21. When the delivery member cover 21 moves linearly from the extended position to the retracted position, the radially inwardly extending protrusions 21b cooperate with the corresponding cam surface 37a, which causes the rotator 37 to rotate from the first rotator position to the second rotator position. The flexible arm 39a is thereby allowed to bend radially outward into a recess or window in the inner surface of the rotator. The plunger rod 29 is thereby released from its initial axial position.

[0078] In use, the cap 1 is first removed from the housing 19, which removes the delivery member shield 13 from the delivery member 25a and exposes the delivery member. The medicament delivery device 17 is then placed on the injection site with the delivery member cover 21 facing the injection site. Next, the delivery member device 17 is pressed toward the injection site, forcing the delivery member cover 21 from the extended position to the retracted position, which triggers the delivery of the medicament as described above.

[0079] During assembly of the drug delivery device 17, the cap 1 may be attached to the proximal housing end 19a in step a). Next, in step b), the drug container 25 having the delivery member shield 13 disposed on the delivery member 25a is arranged or placed in the housing 19 via the distal opening of the housing 19. According to one example, the power pack may be arranged in the housing 19 together with the drug container 25 in step b), because the power pack may be assembled with the drug container 25. Alternatively, the power pack may be placed in the housing in step c) after step b).

[0080] The drug delivery device 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 2 diabetes), psoriasis, migraine, multiple sclerosis, anemia, lupus, atopic dermatitis, asthma, nasal polyps, acute hypoglycemia, obesity, anaphylaxis, and allergic reactions. Exemplary drug types that may be included in the drug delivery device 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 injection assemblies described herein include, but are not limited to (non-limiting examples of relevant diseases are in parentheses): etanercept (rheumatoid arthritis, inflammatory bowel disease (e.g., Crohn's disease and ulcerative colitis)), evolocumab (hypercholesterolemia), exenatide (type 2 diabetes), secukinumab (psoriasis), efrenizumab (migraine), alirocumab (rheumatoid arthritis), methotrexate (rheumatoid arthritis), tocilizumab (rheumatoid arthritis), interferon beta-1a (multiple sclerosis), and levofloxacin (drug therapy). ), sumatriptan (migraine), adalimumab (rheumatoid arthritis), darbepoetin alpha (anemia), belimumab (lupus), peginterferon beta-1a' (multiple sclerosis), salilumab (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 but not limited to any of the drugs described herein are also contemplated for use in the drug delivery devices described herein, such as pharmaceutical formulations comprising the drugs listed herein (or pharmaceutically acceptable salts of the drugs) and a pharmaceutically acceptable carrier. Pharmaceutical formulations comprising the drugs listed herein (or pharmaceutically acceptable salts of the drugs) may include one or more other active ingredients, or may be the only active ingredient present.

[0081] The inventive concept has mainly been described above with reference to a few examples. However, as is readily appreciated by a person skilled in the art, other embodiments than the ones disclosed above are equally possible within the scope of the inventive concept as defined by the appended claims.

Claims

1. A cover (1) for a drug delivery device (17), the drug delivery device comprising a delivery member shield (13), wherein the cover (1) comprises: a body (3) having a proximal end portion (3a) and a distal end portion (3b), wherein the distal end portion (3b) has a smaller radial dimension than the proximal end portion (3a), The distal end portion (3b) has a central passage (3e) configured to receive the delivery member shield (13), The distal end portion (3b) comprises a plurality of flexible first clamps (5) and a plurality of second clamps (7) extending radially inwardly into the central channel (3e), wherein each second clamp (7) extends further than the first clamp (5) in the proximal direction toward the proximal end portion (3a).

2. The cover (1) according to claim 1, wherein each first clamp (5) is semicircular in the circumferential direction of the cover (1).

3. Cap (1) according to claim 1 or 2, wherein the second clamp (7) is pointed.

4. Cap (1) according to claim 3, wherein the second clamp (7) comprises two proximally directed tips (7a).

5. Cap (1) according to claim 4, wherein the tip (7a) of each second clamp is separated by a notch (7b).

6. A cover (1) according to any one of the preceding claims, wherein the distal end portion (3b) comprises an arm (9) extending distally, wherein each first clamp (5) is connected to two adjacent arms (9) in the circumferential direction of the cover (1), and each second clamp (7) is connected to two adjacent arms (9) in the circumferential direction of the cover (1).

7. Cover (1) according to claim 6, wherein each arm (9) is connected to a first clamp (5) and to a second clamp (7).

8. Cover (1) according to any one of the preceding claims, wherein the cover (1) is a single integral part.

9. Cover (1) according to any one of the preceding claims, wherein the cover (1) is made of plastic.

10. A cover (1) according to any one of the preceding claims, wherein each first clamp (5) has a first clamp distal end (5a), and each second clamp (7) has a second clamp distal end (7c), wherein along the longitudinal axis direction of the cover (1), the first clamp distal end (5a) and the second clamp distal end (7c) are horizontal.

11. A drug delivery device (17), comprising: Housing (19), a medicament container (25) arranged in the housing (19), the medicament container comprising a delivery member (5a), a delivery member shield (13) covering the delivery member (25a), and Cap (1) according to any one of the preceding claims, wherein the central channel (3e) of the distal end portion (3b) receives the delivery member shield (13).

12. The drug delivery device (17) according to claim 11, wherein the first clamp (5) abuts against a distal end (14b) of the delivery member shield (13).

13. The drug delivery device (17) according to claim 11 or 12, wherein the delivery member shield (13) includes a plurality of radial shield windows (15), wherein the second clamps (7) each extend into a corresponding shield window (15) of the plurality of radial shield windows (15).

14. A method of assembling a drug delivery device (17) according to any one of claims 11 to 13, the method comprising: a) attaching the cover (1) to the proximal housing end (19a) of the housing (19), and b) arranging the medicament container (25) in the housing (19) via the distal opening of the housing (19) such that the delivery member shield (13) is received by the distal end portion (3b) of the cap (1).

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