Castle-style 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 and extending from an inner surface, the barrel having an adapter attached to the distal tip and including a ring having a plurality of alternating grooves and ribs extending from an outer surface, the adapter being rotatable relative to the barrel, the film including one or more tabs extending from a surface of the film along an edge of the film, the film being configured to correspond and be received in one or more of the plurality of grooves, the film being applied to the barrel and the adapter such 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.

Description

[Technical field]

[0001] This application claims priority to European Patent Application No. 22172374.5, entitled "Castellated Syringe Product Label," filed May 9, 2022, the entire disclosure of which is incorporated herein by reference in its entirety.

[0002] The present invention is directed to a drug delivery device assembly having an adapter element mounted thereon and a film that engages the adapter to prevent rotation of the adapter relative to the remainder of the drug delivery device. [Background technology]

[0003] Once connected to a syringe, it may be desirable to prevent the luer lock adapter from rotating relative to the syringe. This can be accomplished, for example, by heat shrinking a label or other film onto both the adapter and the syringe, as described in U.S. Patent No. 10,661,018, the disclosure of which is incorporated herein by reference in its entirety. However, such a solution may require a heat tunnel apparatus, which can increase capital costs and take up space on the manufacturing floor.

[0004] Furthermore, applying such a label or film to a pre-filled syringe after filling of the device may be undesirable since the heat sensitive composition should not be exposed to unnecessarily heated conditions. Thus, there is a need for a film or label to be applied to the adapter and syringe to prevent relative rotation of the adapter which would eliminate or reduce the need for heat shrinking. There is also a need to provide a more secure, anti-rotation connection between the adapter and the syringe, regardless of the method of application. Summary of the Invention

[0005] Provided herein is a drug delivery device having a barrel defining an interior configured to receive a composition, the barrel having a distal tip and extending from an inner surface, the barrel having an adapter attached to the distal tip and including a ring having a plurality of alternating grooves and ribs extending from an outer surface, the adapter being rotatable relative to the barrel, the film including one or more tabs extending from a surface of the film along an edge of the film, the film being configured to correspond and be received in one or more of the plurality of grooves, the film being applied to the barrel and the adapter such 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.

[0006] In one configuration, the drug delivery device further includes a strip extending from a surface of the film, with one or more tabs extending from the strip. Optionally, the one or more tabs are rounded. In a particular configuration, the one or more tabs include 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.

[0007] In a particular configuration, the one or more tabs and the film are molded together. Optionally, the one or more tabs are molded separately from the film and secured along an edge of the film after molding. The one or more tabs may be co-molded with the film. In a particular configuration, the syringe has a diameter of 10.85 mm.

[0008] In other configurations, the one or more tabs include a plurality of tabs, each of the plurality of tabs being received within a groove of the plurality of grooves in the adapter. The barrel may include glass, and the elastomeric stopper may be received within the interior of the barrel. The drug delivery device may further include a plug removably connected to the adapter. [Brief description of the drawings]

[0009] [Figure 1] FIG. 1 is a perspective view of a drug delivery device assembled with an adapter intended to be attached to the distal tip of the drug delivery device according to a non-limiting embodiment described herein. [Diagram 2] FIG. 2 is a perspective view of a drug delivery device and an adapter once the adapter is attached to the distal tip of the drug delivery device according to a non-limiting embodiment described herein. [Diagram 3] FIG. 3 is a partial cross-sectional view of a syringe assembly according to a non-limiting embodiment described herein. [Figure 4] FIG. 4 is a cross-sectional view of a syringe assembly with a plug attached to an adapter according to non-limiting embodiments described herein. [Diagram 5] FIG. 5 is a side view of a syringe assembly where the heat shrinkable film has dotted lines as a tamper evident measure, with the film also covering a portion of the plug attached to the adapter, according to non-limiting embodiments described herein. [Figure 6] FIG. 6 is a cross-sectional view of a syringe assembly with a connector partially threaded according to non-limiting embodiments described herein. [Figure 7] FIG. 7 is a perspective view of a label of an assembly according to non-limiting embodiments described herein. [Figure 8] FIG. 8 is a perspective view of the label of FIG. 7, showing the label rolled up as it would be applied to an assembly of the present disclosure. [Figure 9] FIG. 9 is another perspective view of a label of an assembly according to non-limiting embodiments described herein. [Figure 10] FIG. 10 is another perspective view of a label of an assembly according to non-limiting embodiments described herein. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0010] The following description is provided to enable a person skilled in the art to make and use the described embodiments contemplated for practicing the invention. However, various modifications, equivalents, variations, and alternatives will be readily apparent to those skilled in the art. Any and all such modifications, variations, equivalents, and alternatives are intended to be within the spirit and scope of the present invention.

[0011] Hereinafter, for purposes of description, the terms "upper," "lower," "right," "left," "vertical," "horizontal," "top," "bottom," "lateral," "longitudinal," and their derivatives shall refer to the invention as oriented in the drawings. It will be understood, however, that the invention may be subject to various alternative modifications unless expressly specified to the contrary. It will also be understood that the specific devices illustrated in the accompanying drawings and described in the following specification are merely exemplary embodiments of the invention. As such, specific dimensions and other physical characteristics relating to the embodiments disclosed herein are not to be considered as limiting.

[0012] It should be understood that any numerical range recited herein is intended to include all subranges subsumed therein. For example, a range "1 to 10" is intended to have all subranges between (and including) the recited minimum value of 1 and the recited maximum value of 10, i.e., minimum values ​​of 1 or more and maximum values ​​of 10 or less.

[0013] Disclosed herein are labels having one or more castellations, and syringe assemblies including such labels, as well as methods of applying such labels to a syringe assembly to prevent or limit rotation of a luer lock adapter present on the syringe.

[0014] Referring to FIG. 1, a drug delivery device 1 of the assembly of the present disclosure is shown. The drug delivery device 1 may include a barrel 2 configured to hold a composition and defining an interior having a distal tip 3. The drug delivery device 1 has a longitudinal axis A. The drug delivery device 1 may be a manual syringe or, optionally, a pre-filled syringe. As shown in this figure, the barrel 2 and the distal tip 3 may be formed of one single element (e.g., plastic, glass, or other known material). The barrel 2 and the distal tip 3 are preferably made of a glass material. The barrel 2 may be sealed at its proximal end by a piston (not shown). The distal tip 3 includes a channel 4 aligned with the longitudinal axis A and provides a passage for the transfer of the composition either from the barrel 2 to a connector such as an IV connector or a syringe needle, or from a vial to the barrel 2. In the example shown, the outer surface 3a of the distal tip 3 has a slightly tapered shape.

[0015] With continued reference to FIG. 1, an adapter 5 is also shown, said adapter 5 including a ring 6. In the illustrated embodiment, the ring 6 is provided at its proximal region with an internal protrusion below in the form of a discontinuous annular bulge 7 extending radially inwards. The discontinuous annular bulge 7 may be made of a material that is sufficiently flexible to allow the discontinuous annular bulge 7 to expand slightly radially outwards under pressure exerted on the inner wall of the bulge 7. Alternatively, the discontinuous annular bulge may be replaced by a continuous annular bulge that can expand radially outwards. The inner wall of the ring 6 is provided with an internal thread 8 spaced distally from the discontinuous annular bulge 7. The adapter 5 is preferably made of a flexible material such as plastic.

[0016] With reference to FIG. 2, the adapter 5 may be attached to the distal tip 3 by a friction fit, adhesive, a threaded connection, or other connection known to those skilled in the art.

[0017] Referring to FIG. 3, a partial view of an assembly 101 is shown in which a drug delivery device 1 is shown with an adapter 5 attached to a distal tip 3. FIG. 3 further shows a film 9, optionally a label including one or more indicia, attached to at least a portion of the barrel 2 and a portion of the adapter 5. Optionally, the film 9 may then be heat shrunk to cover and tightly encase at least a portion of said barrel 2, the distal region 2a of said barrel 2 in the example shown, and at least a portion of the proximal region 5a of the adapter 5 in the example shown. The film 9 may be continuous from the distal region 2a of the barrel 2 to the proximal portion 5a of the adapter 5, and may be disposed to cover an equal amount of the barrel 2 and the adapter 5. The film 9 may be made of a thermoplastic material. In one embodiment, the film 9 is made of a polyvinyl chloride-containing material. In one embodiment, the film 9 may be transparent and / or may include writing, such as, for example, graduations, brand name, lot number, expiration date, drug code, or other useful information.

[0018] As will be explained in more detail below, and as can be seen from FIG. 3 , the adapter 5 is limited and / or prevented from rotating about the longitudinal axis A relative to the barrel 2 and distal tip 3 by the presence of the film 9. The film 9 may also prevent the adapter 5 from translating relative to the barrel 2. As a result, when a user attaches the drug delivery device 1 including the adapter 5 to another device or connector, operation becomes easy and safe.

[0019] 4, an assembly 101 is shown with a plug 10 attached to an adapter 5. The plug 10 may be removably attached to the adapter 5 to protect the adapter 5 and / or maintain sterility of the adapter 5 and may limit access to the adapter 5 prior to use.

[0020] Figure 6 shows the assembly of Figure 3 during the step of screwing the connector 11 onto the adapter 5. The connector 11 is provided with an external thread 12 intended to match the internal thread 8 of the ring 6 of the adapter 5.

[0021] 4 and 6, when a user with an assembly 101 having a closed adapter 5 as shown in FIG. 4 begins the process of connecting the adapter 5 to another device having a luer connection such as a connector 11 (e.g., an IV connector), the user may first grasp the assembly 101 with one hand through the film 9 to remove the plug 10. The user may then attach the connector 11 to the internal threads 8 of the adapter 5 without worrying about rotation of the adapter 5 or axial translation of the adapter 5 relative to the barrel 2, as shown in FIG. 6. When the external threads 12 of the connector 11 are securely received by the internal threads 8 of the adapter 5, the user may be confident that the drug delivery device 1 and the connector 11 are securely connected without risk of leakage.

[0022] 5, another embodiment is shown in which the film 9 is long and covers at least a portion of the plug 10. Thus, the film 9 may cover, optionally continuously, a portion of the barrel 2, the adapter (not shown), and a portion of the plug 10. In such a case, the film 9 may include an annular frangible line 13 that must be broken to remove the plug 10 and open the adapter 5. Thus, the frangible line 13 may function as a tamper indicator.

[0023] With reference to Figures 7-10, the inner surface of the film 9 is shown. As described above, the film 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. The film 9 may also include a label having indicia, providing information related to the contents or use of the drug delivery device 1, as described above. As shown in Figures 1 and 2, the adapter 5 includes alternating grooves 14 and ribs 16 along its outer surface. The film 9 includes one or more cooperating castellations (e.g., tabs) 20 extending from a surface 18 that contacts the adapter 5 and the barrel 2 (e.g., the inner surface of the film 9). The tabs 20 may be located along the edges of the film 9 and may be positioned such that when the film 9 is applied to both the barrel 2 and the adapter 5, they fit within one or more grooves 14 on the adapter 5. When applied to the adapter 5, the tabs 20 engage and interlock with the ribs 16, similar to the locking of a gear on a shaft. This engagement limits and / or prevents relative rotation of the adapter 5 when the film is connected to both the barrel 2 and the adapter 5. The width of the tab 20 may substantially correspond to the width of the groove 14 to establish a strong interlocking effect. As shown, the length of the tab 20 generally corresponds to the length of the groove 14, but different lengths may be used as long as the interlocking effect is maintained and relative rotation of the adapter 5 is prevented. For example, a label 9 having a short length may be used where the label extends only partially along the adapter 5. In this example, the length of the tab 20 does not necessarily correspond to the length of the groove 14, but extends only partially along the adapter 5. Although six tabs 20 are shown in the accompanying figures, 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 tabs 20 and the adapter 5. In some examples, only one tab 20 may be required.

[0024] As shown in FIG. 7, the tabs 20 extend from the surface 18 and are molded directly onto the film 9, spaced apart from each other by a distance corresponding to the size of the ribs 16. FIG. 8 shows the film 9 applied to the drug delivery device 1, but without the barrel 2 or adapter 5 in place. The tabs 20 may also be co-molded with the film 9, or later applied to it after the film 9 has been cut to size. FIG. 9 shows another embodiment of the film 9 having a strip 24 extending from the surface 18 along the edge of the film 9. The tabs 20 are spaced apart along the strip 24 and extend therefrom in a direction away from the film 9. The strip 24 may be molded directly onto the film 9, or may be co-molded and applied to the film 9. FIG. 10 shows a rounded tab 26. The rounded tab 26 allows for greater clearance with the groove 14, allowing the rounded tab 26 to be positioned slightly offset from the groove 14 and still function as described above. The rounded tabs 26 may also be molded directly into the film 9, or they may be co-molded and later affixed thereto. It is contemplated that the tabs 20 may take other shapes, so long as the interlocking effect between the tabs 20 and the grooves 14 is maintained.

[0025] The film 9 may be affixed to the barrel 2 and adapter 5 in the same manner as described above. The film 9 may be heat shrunk onto the barrel 2 and adapter 5, or the film 9 may be provided with an adhesive or other adhesive along surface 18 to adhere to the barrel 2 and lock the adapter 5. The film 9 may also be used in conjunction with the plug 10 in the manner described above. Taking into account the diameter of the adapter 5, the film may be used on a syringe having a diameter of approximately 10.85 millimeters.

[0026] The assembly may be manufactured according to the following, whereby a drug delivery device 1 is provided that includes a barrel 2 for a composition, such as a pharmaceutical composition. The barrel 2 may include a distal tip 3 that contains a channel that provides a passage for the transfer of the composition, and a suitable adapter 5. In a second step, the adapter 5 is connected to the distal tip 3 of the barrel 2, for example, by friction fit. The barrel 2 may optionally be filled with the composition before or after this second step. In a further step, a film 9 is attached to at least a portion of the barrel 2, for example by heat shrink, adhesive, or other similar methods, locking the adapter 5 to the barrel 2 with alignment between one or more tabs 20 and one or more grooves 14 in the adapter 5.

[0027] In non-limiting embodiments in which the film 9 also covers a portion of the plug 10 attached to the adapter 5, the plug 10 may be attached to the adapter 5 prior to adhering the film 9, and a length of the shrinkable film is selected to cover at least a portion of the adapter 5 and the plug 10, optionally in a continuous manner as described above (with or without the optional frangible line as described above). In such embodiments, the one or more tabs 20 are positioned longitudinally on the label 9 such that they still align with and are received by the one or more grooves 14 in the adapter 5.

[0028] While the present disclosure has been described in detail for purposes of illustration based on what are currently considered to be the most practical and preferred embodiments, it is to be understood that such detail is for this purpose only, and that the present disclosure is not limited to the disclosed embodiments, but on the contrary, is intended to cover modifications and equivalent arrangements within the spirit and scope of the appended claims. For example, it is to 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 barrel defining an interior configured to receive a composition, the barrel comprising a distal tip defining a channel for providing a passage for the transfer of the composition, and a barrel; An adapter comprising a ring extending from an inner surface, attached to the distal tip, and including a plurality of alternating grooves and ribs extending from an outer surface, the adapter being rotatable relative to the barrel; A film comprising one or more tabs extending from a surface of the film along an edge of the film, the one or more tabs corresponding to one or more of the plurality of grooves and being configured to be received within the one or more grooves; The drug delivery device, 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, thereby preventing relative rotation between the adapter and the barrel.

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

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

4. The drug delivery device according to claim 1, wherein the one or more tabs have 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 the width of one or more of the plurality of grooves.

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

7. The drug delivery device according to claim 1, wherein the one or more tabs and the film are integrally formed.

8. The drug delivery device according to claim 1, wherein the one or more tabs are formed separately from the film and fixed along the edge of the film after being formed.

9. The drug delivery device according to claim 1, wherein the one or more tabs are co-molded with the film.

10. The drug delivery device according to claim 1, wherein the film is used for a syringe having a diameter of 10.85 mm.

11. The drug delivery device according to claim 1, wherein the one or more tabs include a plurality of tabs, each of the plurality of tabs being received within a groove of the plurality of grooves within the adapter. Claim 12 The drug delivery device according to claim 1, wherein the barrel contains glass. Claim 13 The drug delivery device according to claim 1, further comprising an elastomeric stopper received within the barrel. Claim 14 The drug delivery device according to claim 1, further comprising a plug removably connected to the adapter.

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