Castellated syringe product label

Abstract

Provided herein is a drug delivery device having a barrel defining an interior configured to receive a composition, the barrel having a distal tip, an adapter comprising a ring extending from an interior surface and mounted to the distal tip, and a membrane disposed within the barrel, and a membrane disposed within the barrel and having an alternating plurality of grooves and ribs extending from an outer surface, the adapter rotatable relative to the barrel, the membrane including one or more tabs extending from a surface of the membrane along an edge of the membrane, the one or more tabs correspond to one or more of the plurality of grooves and are configured to be received within the one or more grooves, and the membrane is applied to the barrel and the adapter such that the one or more tabs interlock with one or more of the plurality of grooves, therefore, relative rotation between the adapter and the cylinder is prevented.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims priority to European patent application number 22172374.5, filed on May 9, 2022, and entitled “Castellated Syringe Product Label”, the entire contents of which are hereby incorporated by reference into this document.

[0003] Background of the Invention

[0004] Field of the Invention

[0005] The present invention relates to a drug delivery device assembly having an adapter element mounted thereon and a membrane engaging with the adapter to prevent the adapter from rotating relative to the remainder of the drug delivery device.

[0006] Description of Related Technology

[0007] When connected to a syringe, it may be desirable to prevent the Luer lock adapter from rotating relative to the syringe. This can be accomplished by heat shrinking a label or other film to both the adapter and the syringe, for example, as described in U.S. Pat. No. 10,661,018, the disclosure of which is incorporated herein by reference in its entirety. However, such a solution may require hot channel equipment, which may increase capital costs and take up space on the manufacturing floor.

[0008] Furthermore, it may be undesirable to apply such a label or film to a prefilled syringe after the device is filled, since heat-sensitive compositions should not be unnecessarily exposed to heated conditions. Therefore, there is a need in the art to apply a film or label to an adapter and syringe to prevent relative rotation of the adapters, thereby eliminating or reducing the need for heat shrinking. There is also a need to provide a more secure, anti-rotation connection between an adapter and a syringe, regardless of the method of application. Summary of the invention

[0009] The present invention provides a drug delivery device, which has a barrel, an adapter and a membrane, the barrel defining an interior configured to receive a composition, the barrel having a distal tip, the adapter including a ring extending from an inner surface and mounted on the distal tip, and having a plurality of alternating grooves and a plurality of ribs extending from an outer surface, the adapter being rotatable relative to the barrel, the membrane including one or more tabs extending from a surface of the membrane along an edge of the membrane, the one or more tabs corresponding to one or more of the plurality of grooves and configured to be received in the one or more grooves, the membrane being applied to the barrel and the adapter so that the one or more tabs interlock with one or more of the plurality of grooves, thereby preventing relative rotation between the adapter and the barrel.

[0010] In one configuration, the drug delivery device further comprises a strip extending from the surface of the film, and wherein the one or more tabs extend from the strip. Optionally, the one or more tabs are rounded. In certain configurations, the one or more tabs comprise a width and a length, and the width of the one or more tabs may correspond to the width of one or more of the plurality of grooves. Optionally, the length of the one or more tabs is at least half the length of one or more of the plurality of grooves.

[0011] In some configurations, the one or more tabs are molded with the film. Alternatively, the one or more tabs are molded separately from the film and fixed along the edge of the film after molding. The one or more tabs can be co-molded with the film. In some configurations, the syringe has a diameter of 10.85 mm.

[0012] In other configurations, the one or more tabs include a plurality of tabs, each of the plurality of tabs being received within one of the plurality of grooves in the adapter. The barrel may include glass, and the resilient stop may be received within the interior of the barrel. The drug delivery device may also include a stopper removably connected to the adapter. BRIEF DESCRIPTION OF THE DRAWINGS

[0013] Figure 1 is a perspective view of a drug delivery device and an adapter intended to be mounted on a distal tip of the device according to an assembly of a non-limiting embodiment described herein;

[0014] Figure 2 is a perspective view of a drug delivery device and an adapter according to a non-limiting embodiment described herein, wherein the adapter is mounted on a distal tip of the device;

[0015] Figure 3is a partial cross-sectional view of a syringe assembly according to a non-limiting embodiment described herein;

[0016] Figure 4 is a cross-sectional view of a syringe assembly according to a non-limiting embodiment described herein, wherein a stopper has been installed on an adapter;

[0017] Figure 5 is a side view of a syringe assembly according to a non-limiting embodiment described herein, wherein the film also covers a portion of a stopper mounted on an adapter, the heat shrinkable film having dotted lines as a tamper evident means;

[0018] Figure 6 is a cross-sectional view of a syringe assembly according to a non-limiting embodiment described herein to which a connector has been partially threadedly coupled;

[0019] Figure 7 is a perspective view of a label for an assembly according to a non-limiting embodiment described herein;

[0020] Figure 8 yes Figure 7 A perspective view of a label showing the rolled label as it is applied to an assembly of the present disclosure;

[0021] Fig. 9 is another perspective view of a label for an assembly according to a non-limiting embodiment described herein;

[0022] Fig.10 is another perspective view of a label for an assembly according to a non-limiting embodiment described herein. DETAILED DESCRIPTION

[0023] The following description is provided to enable those skilled in the art to make and use the described embodiments intended for implementing the present invention. However, various modifications, equivalents, variations and substitutes will still be apparent to those skilled in the art. Any and all such modifications, variations, equivalents and substitutes are intended to fall within the spirit and scope of the present invention.

[0024] For the purposes of the description below, the terms "upper", "lower", "right", "left", "vertical", "horizontal", "top", "bottom", "lateral", "longitudinal" and their derivatives will refer to the present invention as oriented in the accompanying drawings. However, it should be understood that the present invention can present various alternative variations, unless expressly stated to the contrary. It should also be understood that the specific devices shown in the drawings and described in the following specification are merely exemplary embodiments of the present invention. Therefore, the specific dimensions and other physical characteristics related to the embodiments disclosed herein should not be considered limiting.

[0025] It should be understood that any numerical range described herein is intended to include all values ​​and subranges contained therein. For example, a range of "1 to 10" is intended to include all subranges between the stated minimum value 1 and the stated maximum value 10 (including 1 and 10), i.e., having a minimum value equal to or greater than 1 and a maximum value equal to or less than 10.

[0026] Disclosed herein are a label having one or more castellations and a syringe assembly including such a label, as well as a method of applying such a label to a syringe assembly to prevent or limit rotation of a Luer lock adapter present on the syringe.

[0027] refer to Figure 1 , Figure 1 A drug delivery device 1 of an assembly of the present disclosure is shown. The drug delivery device 1 may include a barrel 2, which defines an interior configured to hold a composition, and the barrel has a distal end 3. The drug delivery device 1 has a longitudinal axis A. The drug delivery device 1 may be a manual syringe, optionally a prefilled syringe. As shown in the figure, the barrel 2 and the distal end 3 may be formed by a single element (e.g., plastic, glass or other known materials). The barrel 2 and the distal end 3 are preferably made of glass material. The barrel 2 may be sealed at its proximal end by a piston (not shown). The distal end 3 includes a channel 4, which is aligned with the longitudinal axis A and provides a path for the transmission of the composition from the barrel 2 to a connector (e.g., an IV connector) or an injection needle or from a vial to the barrel 2. In the example shown, the outer surface 3a of the distal end 3 has a slightly tapered shape.

[0028] Continue to refer Figure 1 , Figure 1 An adapter 5 is also shown, which includes a ring 6. In the embodiment shown, the ring 6 is provided with an inner protrusion extending radially inwards in its proximal region, which is in the form of a discontinuous annular protrusion 7. The discontinuous annular protrusion 7 can be made of a material that is soft enough to allow the discontinuous annular protrusion 7 to expand slightly radially in an outward direction under pressure applied to the inner wall of the protrusion 7. Alternatively, the discontinuous annular protrusion can be replaced by a continuous annular protrusion that can expand radially outwards. The inner wall of the ring 6 is provided with an internal thread 8 that is spaced distally from the discontinuous annular protrusion 7. The adapter 5 is preferably made of a flexible material, such as plastic.

[0029] Go to Figure 2 , the adapter 5 can be mounted on the distal tip 3 by friction fit, adhesive, threaded connection or other connection known to those skilled in the art.

[0030] refer to Figure 3 , Figure 3 A partial view of an assembly 101 is shown, wherein the drug delivery device 1 is shown with the adapter 5 mounted on the distal tip 3 . Figure 3 Also shown is a film 9, which is optionally a label including one or more marks, which has been attached to at least a portion of the barrel 2 and at least a portion of the adapter 5. Optionally, the film 9 can be heat-shrunk to cover and tightly wrap at least a portion of the barrel 2 (in the example shown, the distal region 2a of the barrel 2) and at least a portion of the adapter 5 (in the example shown, the proximal region 5a of the adapter 5). The film 9 can be continuous from the distal region 2a of the barrel 2 to the proximal portion 5a of the adapter 5, and can be arranged to cover equal amounts of the barrel 2 and the adapter 5. The film 9 can be made of a thermoplastic material. In an embodiment, the film 9 is made of a material containing polyvinyl chloride. In an embodiment, the film 9 can be transparent and / or can include text, such as graduations, brand names, batch numbers, expiration dates, drug codes or other useful information.

[0031] As will be explained in more detail below, Figure 3 It is understood that due to the presence of the membrane 9, the rotation of the adapter 5 relative to the barrel 2 and the distal tip 3 about the longitudinal axis A is limited and / or prevented. The membrane 9 can also prevent the translation of the adapter 5 relative to the barrel 2. Therefore, when the user continues to attach the drug delivery device 1 including the adapter 5 to another device or connector, the operation becomes convenient and safe.

[0032] Go to Figure 4 , Figure 4 An assembly 101 is shown having a plug 10 mounted on an adapter 5. The plug 10 may be removably mounted on the adapter 5 and may restrict access to the adapter 5 prior to use to protect the adapter 5 and / or maintain the sterility of the adapter 5.

[0033] Figure 6 The diagram shows the process of threading the connector 11 onto the adapter 5 during the step of threading the connector 11 onto the adapter 5. Figure 3 The connector 11 is provided with an external thread 12 which is intended to match the internal thread 8 of the ring 6 of the adapter 5 .

[0034] Go to Figure 4 and Figure 6 , when the user is provided with a component 101 (the adapter 5 of the component 101 is as Figure 4 When beginning the process of connecting the adapter 5 to another device (e.g., connector 11) having a Luer connection (e.g., an IV connector) with the adapter 5 shown closed, the user can first grasp the assembly 101 with one hand through the membrane 9 to remove the plug 10. The user can then attach the connector 11 to the internal threads 8 of the adapter 5 (e.g., Figure 6 ), regardless of the rotation of the adapter 5 relative to the barrel 2 or the axial translation of the adapter 5 relative to the barrel 2. When the external thread 12 of the connector 11 is securely received by the internal thread 8 of the adapter 5, the user can be sure that the drug delivery device 1 and the connector 11 are tightly connected without the risk of leakage.

[0035] Go to Figure 5 , Figure 5 Another embodiment is shown, in which the membrane 9 is longer and covers at least a portion of the stopper 10. Thus, the membrane 9 may cover a portion of the barrel 2, an adapter (not shown) and a portion of the stopper 10, optionally in a continuous manner. In this case, the membrane 9 may be provided with an annular breakable line 13, which must be broken in order to remove the stopper 10 and open the adapter 5. Thus, the breakable line 13 may serve as a tamper indicator.

[0036] Go to Figures 7 to 10 , Figures 7 to 10 The inner surface of the membrane 9 is shown. As described above, the membrane 9 can be attached to both the adapter 5 and the barrel 2 to limit or prevent relative rotation between the adapter 5 and the barrel 2. As described above, the membrane 9 can also include a label with indicia to provide information related to the contents or use of the drug delivery device 1. Figure 1 and Figure 2As shown, the adapter 5 includes alternating grooves 14 and ribs 16 along its outer surface. The membrane 9 includes one or more cooperating castellated structures (e.g., tabs) 20 extending from a surface 18 (e.g., an inner surface of the membrane 9) that contacts the adapter 5 and the barrel 2. One or more tabs 20 can be provided along the edge of the membrane 9, and the one or more tabs 20 can be arranged so that when the membrane 9 is applied to both the barrel 2 and the adapter 5, the one or more tabs fit into one or more of the grooves 14 on the adapter 5. When applied to the adapter 5, the one or more tabs 20 engage and interlock with the ribs 16, similar to a locking gear on a shaft. Considering the connection of the membrane to both the barrel 2 and the adapter 5, this engagement limits and / or prevents relative rotation of the adapter 5. The width of the one or more tabs 20 can generally correspond to the width of the grooves 14 to establish a strong interlocking effect. As shown, the length of the one or more tabs 20 generally corresponds to the length of the grooves 14, but different lengths can be used as long as the interlocking effect is maintained and the relative rotation of the adapter 5 is prevented. For example, a label 9 having a short length may be used that extends only partially along the adapter 5. In this case, the length of the one or more tabs 20 does not necessarily correspond to the length of the groove 14, but only extends partially along the adapter 5. Although six tabs 20 are shown in the drawings, it is contemplated that any number of tabs 20 may be used to engage any number of grooves 14, depending on the design and desired strength of the interlock between the tab 20 and the adapter 5. In some cases, only one tab 20 may be required.

[0037] like Figure 7 As shown, one or more tabs 20 are molded directly into the membrane 9 , extending from the surface 18 and spaced apart from each other by a distance corresponding to the size of the ribs 16 . Figure 8 The film 9 is shown as it is applied to the drug delivery device 1, but without the cartridge 2 or the adapter 5 in place. The tabs 20 may also be co-moulded with the film 9 and subsequently fixed to the film after it has been cut to size. Fig. 9 Another embodiment of a membrane 9 is shown having a strip 24 extending from the surface 18 along the edge of the membrane 9. The tabs 20 are spaced along the strip 24 and extend from the strip 24 in a direction away from the membrane 9. The strip 24 may be molded directly into the membrane 9, or the strip 24 may be co-molded with the membrane 9 and secured thereto. Fig.10A rounded tab 26 is shown. The rounded tab 26 allows for greater clearance with the groove 14 and allows the rounded tab 26 to be placed slightly offset from the groove 14 and still function as previously described. The rounded tab 26 may also be molded directly into the membrane 9, or the rounded tab 26 may be co-molded with the membrane 9 and subsequently secured thereto. It is contemplated that the tab 20 may take other shapes as long as the interlocking effect between the tab 20 and the groove 14 is maintained.

[0038] The membrane 9 can be applied to the barrel 2 and adapter 5 in the same manner as described above. The membrane 9 can be heat shrunk to the barrel 2 and adapter 5, or the membrane 9 can be provided with glue or other adhesive along the surface 18 so as to adhere to the barrel 2 and lock the adapter 5. The membrane 9 can also be used in combination with the stopper 10 in the manner described above. Taking into account the diameter of the adapter 5, the membrane can be used on a syringe with a diameter of about 10.85 mm.

[0039] The assembly can be manufactured according to the following: a drug delivery device 1 comprising a barrel 2 for a composition (e.g., a pharmaceutical composition) can be provided. The barrel 2 can include a distal tip 3 and a suitable adapter 5, the distal tip including a channel that provides a passage for the delivery of the composition. In a second step, the adapter 5 is connected to the distal tip 3 of the barrel 2, for example by friction fit. Optionally, the barrel 2 can be filled with the composition before or after the second step. In another step, a film 9 is attached to at least a portion of the barrel 2, for example by heat shrinking, adhesive or other similar methods, so as to lock the adapter 5 relative to the barrel 2, wherein one or more tabs 20 are aligned with one or more grooves 14 in the adapter 5.

[0040] In non-limiting embodiments where the film 9 also covers a portion of the plug 10 mounted on the adapter 5, the plug 10 can be mounted on the adapter 5 prior to bonding the film 9, and the length of the shrinkable film can be selected to cover the adapter 5 and at least a portion of the plug 10, optionally in a continuous manner as described above (with or without the optional break line as described above). In such an embodiment, the one or more tabs 20 are arranged longitudinally on the label 9 so as to remain aligned with and received by the one or more grooves 14 in the adapter 5.

[0041] Although the present disclosure has been described in detail based on what are currently considered to be the most practical and preferred embodiments for the purpose of illustration, it should be understood that such detail is for that purpose only and that the present disclosure is not limited to the disclosed embodiments, but rather, the present disclosure is intended to cover modifications and equivalent arrangements that fall within the spirit and scope of the appended claims. For example, it should be understood that the present disclosure contemplates that, to the extent possible, one or more features of any embodiment may be combined with one or more features of any other embodiment.

Claims

1. A drug delivery device, comprising: a barrel defining an interior configured to receive a composition, the barrel including a distal tip defining a passageway for providing a pathway for delivery of the composition; an adapter including a ring extending from the inner surface and mounted to the distal tip and including a plurality of alternating grooves and a plurality of ribs extending from the outer surface, the adapter being rotatable relative to the barrel; as well as a membrane comprising one or more tabs extending from a surface of the membrane along an edge of the membrane, the one or more tabs corresponding to one or more grooves of the plurality of grooves and configured to be received within the one or more grooves, Wherein the film is configured to be applied to the barrel and the adapter such that the one or more tabs interlock with one or more of the plurality of grooves to prevent relative rotation between the adapter and the barrel.

2. The drug delivery device of claim 1 further comprising a strip extending from the surface of the membrane, and wherein: The one or more tabs extend from the strip.

3. The drug delivery device according to claim 1 or 2, wherein: The one or more tabs are rounded.

4. The drug delivery device according to any one of claims 1 to 3, wherein: The one or more tabs include a width and a length.

5. The drug delivery device according to claim 4, wherein: The width of the one or more tabs corresponds to a width of one or more grooves of the plurality of grooves.

6. The assembly according to claim 4, wherein: The length of the one or more tabs is at least half the length of one or more grooves of the plurality of grooves.

7. The drug delivery device according to any one of claims 1 to 6, wherein: The one or more tabs are molded together with the membrane.

8. The drug delivery device according to any one of claims 1 to 7, wherein: The one or more tabs are molded separately from the membrane and are secured along the edge of the membrane after molding.

9. The drug delivery device according to any one of claims 1 to 7, wherein: The one or more tabs are co-molded with the membrane.

10. The drug delivery device according to any one of claims 1 to 9, wherein: The syringe had a diameter of 10.85 mm.

11. The drug delivery device according to any one of claims 1 to 10, wherein: The one or more tabs include a plurality of tabs, each tab of the plurality of tabs being received within one of the plurality of grooves in the adapter.

12. The drug delivery device according to any one of claims 1 to 11, wherein: The barrel comprises glass.

13. A drug delivery device according to any one of claims 1 to 12, further comprising a resilient stopper received within the interior of the barrel.

14. The drug delivery device according to any one of claims 1 to 13, further comprising a bung detachably connected to the adapter.

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