Sub-assembly of medicament delivery device and medicament delivery device

Abstract

The present disclosure relates generally to medicament delivery devices, such as autosyringes, and in particular to subassemblies for removing needle shields.

Description

Technical Field

[0001] The present disclosure relates generally to drug delivery devices such as autoinjectors, and particularly to needle covers and subassemblies for removing needle shields. Background Art

[0002] Many medical conditions require injections. Currently, there are many different injection devices, including various types of pen injectors, autoinjectors, and in vivo devices. Although many of these devices have achieved significant improvements in the management of many medical conditions, there are still various limitations in the current technology. In particular, patients who need frequent injections and patients who need to inject particularly viscous drugs face difficulties. In considering these issues, the applicant has realized that various developments can be made to help improve the drug delivery devices on the market today, such as the removal of the needle shield of the drug delivery device, which will be described in more detail below. Summary of the invention

[0003] It is an object of the present disclosure to provide a needle cover and a subassembly for a medicament delivery device which solves or at least alleviates the problems of the prior art.

[0004] According to a first aspect of the present invention, a subassembly of a drug delivery device is provided, the subassembly being used to remove a needle shield of the drug delivery device, the drug delivery device extending from a proximal end to a distal end along a longitudinal axis, the needle shield being configured to cover a needle attached to a proximal end of a drug container contained in a housing, the subassembly comprising: a cap-shaped member configured to cover the needle shield; a flexible clamp attached to the cap-shaped member, the flexible clamp extending distally toward the drug container, the clamp being configured to be radially arranged on the outside of the needle shield; and a syringe holder. , the syringe holder is adapted to be accommodated in the housing, the syringe holder includes a tubular proximal body, the tubular proximal body is configured to radially receive the medicament container inside the tubular proximal body, the tubular proximal body includes a first portion and a second portion, the second portion is proximally adjacent to the first portion, wherein the tubular proximal body includes the first portion and the second portion, the second portion is proximally adjacent to the first portion, wherein the first portion includes a first inner diameter or cutout that is larger than the outer diameter of the flexible holder; wherein the second portion includes a second inner diameter that is smaller than the outer diameter of the flexible holder,

[0005] Embodiments of the present disclosure advantageously provide for removal of a removable needle shield as the cap moves proximally, and also provide an efficient assembly process. The disclosed embodiments provide the flexible holder capable of radially outward bending when it is aligned with the first portion or the cutout of the tubular proximal body. Thus, during the assembly process, the needle shield can be easily moved past the flexible holder and into the cap. When the device is assembled, movement of the cap in the proximal direction typically prepares the drug delivery device for use. Advantageously, removal of the cap results in removal of the needle shield using the flexible holder, so that the user does not have to manually remove the needle shield, which could result in unnecessary risk of sharps injury.

[0006] The first portion and the second portion of the tubular proximal body may be coaxial or circumferentially offset.

[0007] 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 delivery device or a portion / end of a component of a delivery device that is positioned farthest from a dose delivery site during use of a medication delivery device. Accordingly, when the term "proximal direction" is used, this refers to a direction pointing towards a dose delivery site during use of a medication delivery device. When the term "proximal portion / proximal end" is used, this refers to a portion / end of a delivery device or a portion / end of a component of a delivery device that is positioned closest to a dose delivery site during use of a medication delivery device.

[0008] 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.

[0009] Similarly, the terms "lateral," "transverse," and "transversely" refer to a direction generally perpendicular to the longitudinal direction.

[0010] Additionally, the terms "circumferential," "circumferential," and "circumferentially" refer to a circumferential or circumferential direction 301 relative to an axis 102, which is typically a central axis extending in the direction of longest extension of the device and / or assembly. Similarly, "radial" or "radially" refer to a direction 302 extending radially relative to an axis, and "rotational," "rotational," and "rotationally" refer to rotation relative to an axis.

[0011] According to one embodiment, the flexible holder is housed inside the tubular proximal body of the syringe holder, for example, when the tubular proximal body of the syringe holder is substantially cylindrical.

[0012] Alternatively, in another embodiment, a cutout is disposed in the wall of the tubular proximal body of the syringe holder. The cutout may be used as a window for the user to view the contained medicament. In this example, the flexible holder may be aligned with the cutout before being moved to align with the second portion of the tubular proximal body of the syringe holder. In this example, the flexible holder may be positioned within the cutout or extend radially out of the cutout. In this embodiment, the cutout defines the first portion of the tubular proximal body.

[0013] According to one embodiment, the holder may include a protrusion extending radially outwards. The protrusion extending radially outwards provides an advantageous way to achieve engagement between the tubular proximal body and the flexible holder, in particular engagement with the second portion of the tubular proximal body, which causes the flexible holder to be pressed radially inwards.

[0014] According to one embodiment, the flexible holder may be annular in shape.

[0015] According to one embodiment, the flexible holder may comprise at least one distally extending flexible arm.The distally extending flexible arm provides a simple but robust way of providing radially inward flexing movement of the flexible holder.

[0016] According to one embodiment, each flexible arm comprises a protrusion extending radially outwardly.

[0017] According to one embodiment, the flexible retainer engages with the distal end portion of the needle shield.When the cap moves proximally, the engagement provides for removal of the needle shield.

[0018] According to one embodiment, wherein the retainer engages with a side surface of the needle shield, the engagement provides for removal of the needle shield when the cap moves proximally.

[0019] According to one embodiment, the flexible retainer may be configured to engage with the needle shield via a friction connection.

[0020] According to one embodiment, the flexible holder may include a radially inwardly extending protrusion configured to abut against the distal end of the needle shield when the holder moves from the first portion toward the second portion of the tubular proximal body. This form-fitting engagement provides a robust engagement between the flexible holder and the needle shield.

[0021] According to one embodiment, the flexible holder may include a tubular body for receiving the needle shield, the tubular body including at least one protrusion extending radially inwardly to engage with the needle shield by friction.

[0022] According to one embodiment, the at least one protrusion of the tubular body is at least one rib extending longitudinally along the cap.

[0023] According to one embodiment, the inner diameter of the tubular body of the flexible holder may be larger than the outer diameter of the needle shield.

[0024] According to one embodiment, the holder and the cap may be integrally made as a single component.

[0025] According to one embodiment, the holder may be made of a plastic material.

[0026] Also provided is a drug delivery device comprising a subassembly of any of the embodiments disclosed herein.

[0027] A method of assembling a drug delivery device is also provided. The method comprises the following steps in the following order:

[0028] - providing a subassembly, wherein the subassembly includes a cap-like member including a flexible holder extending distally; and a syringe holder including a tubular proximal body, wherein the tubular proximal body includes a first portion and a second portion, the second portion being proximally adjacent to the first portion, wherein the first portion includes at least one of the first inner diameters being larger than the outer diameter of the flexible holder; wherein the second portion includes a second inner diameter being smaller than the outer diameter of the flexible holder; and wherein the flexible holder is received within the first portion of the proximal tubular body;

[0029] - providing a medicament container assembly; wherein the medicament container assembly comprises a medicament container and a needle shield; wherein the medicament container comprises a needle attached at the proximal end of the medicament container; wherein the needle is covered by the needle shield;

[0030] - inserting the medicament container assembly into the tubular proximal body of the syringe holder from the distal end of the tubular end of the proximal tubular body of the syringe holder; and

[0031] - axially moving the medicament container assembly within the tubular proximal body until the flexible holder is radially aligned with the needle shield or positioned distally relative to the needle shield.

[0032] In general, unless otherwise expressly defined herein, all terms used in the claims should be interpreted according to their ordinary meaning in the technical field. Unless otherwise expressly stated, all references to "a / an / the member, device, component, part, etc." should be openly interpreted as referring to at least one instance of a member, device, component, part, etc. BRIEF DESCRIPTION OF THE DRAWINGS

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

[0034] Figure 1 is a perspective view of an autoinjector according to an embodiment of the present disclosure;

[0035] Figure 2 is an exploded view of an autoinjector according to an embodiment of the present disclosure;

[0036] Figure 3 is a perspective view of a cap according to an embodiment of the present disclosure;

[0037] Figure 4 is another perspective view of a cap according to an embodiment of the present disclosure;

[0038] Figure 5 is a perspective view of a syringe holder according to an embodiment of the present disclosure;

[0039] Figure 6 is a close-up perspective view of a syringe holder according to an embodiment of the present disclosure;

[0040] Figure 7 is a perspective view of a removable needle shield according to an embodiment of the present disclosure;

[0041] Figure 8 is a cross-sectional view of a subassembly in an initially assembled state according to an embodiment of the present disclosure;

[0042] Fig. 9 is a cross-sectional view of a subassembly with a cap partially removed according to an embodiment of the present disclosure; and

[0043] Fig.10 is a close-up cross-sectional view of a medication delivery device at the distal end of a syringe according to an embodiment of the present disclosure. DETAILED DESCRIPTION

[0044] 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 the 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 components.

[0045] Figure 1An example of a drug delivery device 1 such as an autoinjector according to an embodiment of the present disclosure is shown. The drug delivery device 1 is configured to expel a drug from a drug container to a user at a dose delivery site via a drug delivery member such as a needle. The drug delivery device 1 extends from a proximal end 1a to a distal end 1b relative to an axis 102.

[0046] The drug delivery device 1 comprises a housing 3 having a proximal end 3a and a distal end 3b.

[0047] The drug delivery device 1 further comprises a cap 10 releasably attached to the proximal end 3 a of the housing 3 .

[0048] Figure 2 is an exploded view of the drug delivery device 1 , which also includes a needle cover 5 , a needle cover spring 7 , a drug container 8 (ie, a syringe) accommodated in the housing 3 , and a needle shield 9 configured to cover the needle attached to the proximal end of the drug container 8 .

[0049] The drug delivery device 1 further includes a plunger rod 12, a plunger rod spring 14, a plunger rod spring guide 16, a U-shaped bracket 18, a rotating body 20, and a rear cover 22. Generally speaking, the plunger rod 12 is configured to move the stopper in the syringe 8 in the proximal direction when moved by the plunger rod spring 14, so that the drug contained in the drug container 8 is discharged.

[0050] Figure 3 is a perspective view of a cap 10 according to an embodiment of the present disclosure. A flexible holder 15 is attached to the cap 10 and faces Figure 2 The medicament container 8 is shown extending distally. Furthermore, the flexible holder 15 is configured to be arranged radially outside the needle shield 9.

[0051] The flexible holder 15 comprises a set of distally extending flexible arms 32. Each flexible arm 32 comprises a radially outwardly extending protrusion 30 on its respective distal end 31. The distal end 31 is a free end of the flexible arm 32 which is radially bendable relative to a fixed end 34 in the proximal end of the flexible arm 32. The fixed proximal end 34 is attached to or made in one piece with the tubular body 40 of the cap.

[0052] The flexible holder 15 is annular in shape and has a circular circumference. In this embodiment, the annular flexible holder 15 comprises four flexible arms 32, which are symmetrically arranged and extend in a distal direction away from the tubular body 40. In practice, it is possible that the flexible holder comprises at least two flexible arms.

[0053] The tubular body 40 has an outer diameter that is greater than the outer diameter of the flexible holder 15 at the fixed end 34 of the flexible arm 32 .

[0054] Radially outwardly extending projection 30 includes a proximally facing surface 36 that is inclined relative to axis 102 .

[0055] Figure 4 is another perspective view of the cap 10, more clearly illustrating the interior space of the tubular body 40. The tubular body is attached to a distally facing surface 41 at the proximal end of the cap 10. Furthermore, an outer annular wall 44 is coaxially arranged with the tubular body 40 and is adapted to be grasped by a user to remove the cap 10 from the drug delivery device 1.

[0056] The interior space of the tubular body 40 is adapted to receive the needle shield 9. Therefore, the inner diameter of the tubular body 40 is larger than the outer diameter of the needle shield 9. However, the tubular body 40 includes at least one protrusion 45 extending radially inwardly to engage with the needle shield by friction. Preferably, the tubular body includes a set of protrusions 45 symmetrically arranged on the side wall 43 of the tubular body 40 facing radially inwardly.

[0057] In this embodiment, the at least one protrusion 45 of the tubular body 40 is at least one rib or extruded rib extending longitudinally along the cap 10. The rib 45 may extend, for example, along about half of the longitudinal length of the tubular body 40, or along about 75% or more of the longitudinal length of the tubular body 40. In some embodiments, the rib extends along about 20% or more of the longitudinal length of the tubular body 40.

[0058] Preferably, the flexible holder 15 and the cap 10 are made integrally as a single component.The flexible holder 15 may be made of a plastic material, for example.

[0059] Figure 5 is a cross-sectional view of the syringe holder 50. The syringe holder 50 is accommodated in the housing 3, and may or may not be made integrally with the housing 3, depending on the specific implementation of the vicinity.

[0060] The flexible tab 80 is configured to abut against a flange 84 of the syringe 8, as will be described with reference to Fig.10 discussed in more detail.

[0061] As in Figure 6 As better seen in , the syringe holder 50 includes a tubular proximal body 52. ​​The tubular proximal body 52 is configured to receive the medicament container 8 radially inside the tubular proximal body 52. ​​In other words, the medicament container 8 is assembled within the tubular proximal body 52 so that the needle passes through the tubular proximal body 52.

[0062] The tubular proximal body 52 includes a first portion 55 and a second portion 57 that is proximally adjacent to the first portion 55. In the depicted embodiment, the first portion 55 of the tubular proximal body 52 has a first inner diameter that is larger than the outer diameter of the flexible holder 15. However, in other possible embodiments, the first portion 55 may alternatively include a cutout through which the protrusion 30 of the flexible arm 32 is disposed.

[0063] The second portion 57 of the tubular proximal body 50 has a second inner diameter that is smaller than the outer diameter of the flexible holder 15. The tubular body 50 also includes a distally facing surface 59 that is inclined relative to the longitudinal axis 102. The inclined surface is located at the interface between the first portion 55 and the second portion 57.

[0064] Figure 7 is a perspective view of a needle shield 9. The needle shield 9 may be a rigid needle shield (RNS) or a flexible needle shield (FNS). The needle shield 9 includes a distal end portion 65 positioned proximally relative to the distal end of the flexible clamp 31. The flexible clamp 15 is configured to engage with the distal end portion 65 of the needle shield and / or a side surface 67 of the needle shield. For example, the flexible clamp 15 may include a radially inwardly extending protrusion that is configured to abut against the distal end 65 of the needle shield when the flexible clamp moves from the first portion of the tubular proximal body toward the second portion.

[0065] Figure 8 is a cross-sectional view of the subassembly 2 including the cap 10 and the syringe support 50. Figure 8 , the subassembly 2 is in an initially assembled state. In this embodiment, the flexible retainer 15 or more precisely the protrusion 30 is located at the first portion 55 of the tubular proximal body 52. ​​In this state, the flexible arms 32 are in a neutral position, i.e. not bent inwardly, and therefore not engaged with the needle shield 9.

[0066] Steering Fig. 9 , which shows a subassembly in a state where the cap 10 is moved in the proximal direction for removal. The flexible holder 15 (here the flexible arm 32 and the protrusion 30) has moved from the first portion 55 of the tubular proximal body 52 to the second portion 57. When the flexible arm reaches the second portion 57, the flexible arm 32 is pressed radially inwardly to engage with the needle shield 9, the second portion having an inner diameter smaller than the outer diameter of the flexible holder 15 at the protrusion 30. Here, the radially inwardly facing surface 70 of the flexible arm 32 engages with the side surface 67 of the needle shield by friction.

[0067] about Figure 4The ribs 45 of the cap 10 in question strengthen the connection between the cap 10 and the needle shield 9 and further prevent the needle shield 9 from falling off the cap after the cap is removed from the drug delivery device 1 .

[0068] Fig.10 is a cross-sectional view of a drug delivery device 1. Here, the distal end of the syringe 8 is shown as having a distal annular flange 84. To provide support for the syringe 8 (which holds the syringe 8 in place when the cap 10 pulls the needle shield 8 away from the syringe 8), the flange is supported on a radially inwardly extending flexible tab 80 so that the distal end of the flexible tab contacts a proximally facing surface 86.

[0069] A drug delivery device, such as an autoinjector, may typically include various other components. For example, a sensor unit that can identify injection events, such as an autoinjector inserted into, for example, an attachment portion of a pad, the start of an injection, and the end of an injection; a memory unit that is configured to store recorded data during an injection; a connection unit that is configured to send the stored data directly to a smart device or network; a processing unit that is configured to control the entire system and process the data before sending it; and / or a user interface unit that is configured to provide feedback to the patient, such as a status LED, tactile feedback, and / or audio feedback.

[0070] When a drug delivery device is placed into the attachment portion, sensors inside the pad are configured to recognize the event and give feedback to the patient via tactile / visual or audio elements.

[0071] When the injection is complete, the sensor is configured to recognize the event and give feedback to the patient again. In addition, the collected data is stored in the memory unit and can be sent to the smart device / network via the connection unit after the injection event is over.

[0072] The sensor can be one or a combination of the following: mechanical switch, Hall effect sensor, accelerometer.

[0073] A mechanical switch, Hall effect sensor, or accelerometer may be used to detect insertion of the autoinjector into the injection port.

[0074] An accelerometer can be used to detect injection events.

[0075] Possible wireless communication methods include Bluetooth and cellular networks.

[0076] Bluetooth connection requires the smart device to send stored data to the network, and in case of a two-way connection, it requires a pairing action between the pad and the smart device before the supporting pad can be used. But it is a cheaper alternative and it requires less space on the PCB. Bluetooth connection does not require pairing.

[0077] Cellular network does not require any pairing process, it can be used as a plug and play device, no previous setup is required, but it is more expensive and it requires more space on the PCB.

[0078] Depending on the requirements of the product, either of these two techniques can be used.

[0079] Such a processing unit may include a logic circuit or control unit, including a microprocessor, a microcontroller, a programmable digital signal processor, or another programmable device. The processing circuits may also or alternatively each include an application specific integrated circuit, a programmable gate array or programmable array logic, a programmable logic device, or a digital signal processor. Where the processing circuit includes a programmable device such as a microprocessor, a microcontroller, or a programmable digital signal processor as described above, the processor may also include computer executable code that controls the operation of the programmable device.

[0080] Drug delivery devices as described herein can be used to treat and / or prevent one or more diseases in 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 drug delivery devices as 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 agents that may be included in the drug delivery devices 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), amethopterin (rheumatoid arthritis), tocilizumab (rheumatoid arthritis), interferon beta-ia ( Multiple sclerosis), sumatriptan (migraine), adalimumab (rheumatoid arthritis), darbepoetin alfa (anemia), belimumab (lupus), peginterferon beta-ia' (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 subassembly (2) of a drug delivery device (1), the subassembly being used to remove a needle shield (9) of the drug delivery device (1), the drug delivery device extending along a longitudinal axis (102) from a proximal end (1a) to a distal end (1b), the needle shield being configured to cover a needle attached to a proximal end of a drug container (8) contained in a housing (3), the subassembly comprising: a cap-shaped member (10) configured to cover the needle shield, a flexible holder (15) attached to the cap-shaped member, the flexible holder extending distally toward the medicament container, the flexible holder being configured to be arranged radially outside the needle shield, a syringe holder (50) adapted to be received in the housing, the syringe holder comprising a tubular proximal body (52) configured to radially receive the medicament container inside the tubular proximal body, wherein the tubular proximal body comprises a first portion (55) and a second portion (57), the second portion being proximally adjacent to the first portion, wherein the first portion comprises a first inner diameter or cutout that is larger than the outer diameter of the flexible holder; wherein the second portion (57) comprises a second inner diameter that is smaller than the outer diameter of the flexible holder, Wherein when the cap is moved proximally to be removed from the drug delivery device, the flexible holder is moved from the first portion toward the second portion of the tubular proximal body, whereby the flexible holder is pressed radially inwardly to engage with the needle shield.

2. The subassembly of claim 1, wherein the flexible holder comprises a protrusion (30) extending radially outwardly.

3. The subassembly according to any one of claims 1 and 2, wherein the flexible holder is annular in shape.

4. The subassembly according to any of the preceding claims, wherein the flexible holder comprises at least one flexible arm (32) extending distally.

5. The subassembly of claim 4, wherein each flexible arm comprises a protrusion (30) extending radially outwardly.

6. A subassembly according to any one of the preceding claims, wherein the flexible retainer engages with a distal end portion (65) of the needle shield.

7. A subassembly according to any one of claims 1 to 5, wherein the flexible retainer engages a side surface (67) of the needle shield.

8. A subassembly according to any one of the preceding claims, wherein the flexible retainer is configured to engage with the needle shield via a friction connection.

9. A subassembly according to any one of claims 1 to 7, wherein the flexible clamp includes a radially inwardly extending protrusion, and the radially inwardly extending protrusion is constructed to abut the distal end of the needle shield when the flexible clamp moves from the first portion of the tubular proximal body toward the second portion.

10. A subassembly according to any of the preceding claims, wherein the flexible holder comprises a tubular body (40) for receiving the needle shield, the tubular body comprising at least one protrusion (45) extending radially inwardly to engage with the needle shield by friction.

11. The subassembly according to claim 10, wherein the at least one protrusion (45) of the tubular body is at least one rib extending longitudinally along the cap.

12. The subassembly of any one of claims 10 and 11, wherein the inner diameter of the tubular body of the flexible holder is greater than the outer diameter of the needle shield.

13. The subassembly according to any one of the preceding claims, wherein the flexible holder and the cap are integrally made as a single component.

14. A subassembly according to any one of the preceding claims, wherein the flexible holder is made of a plastic material.

15. A drug delivery device comprising a subassembly according to any one of the preceding claims.

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