Syringe assembly with in-mold RFID sleeve

Abstract

The syringe assembly includes a syringe having a reservoir and a distal tip, a cap component engaging the distal tip, and an identification sleeve engaging the cap component via one or more engagement features extending from at least one of the cap component and the identification sleeve, the identification sleeve including an RFID tag for enabling traceability of said syringe prior to final product labeling.

Description

Technical Field

[0001] The present disclosure relates to a medical infusion device that utilizes a data tag or inlay such as a radio frequency identification (RFID) tag or inlay.

Background Art

[0002] Cross - reference to related applications This application claims priority to European Patent Application No. 21306295.3, titled "Syringe Assembly with In - Molded RFID Sleeve", filed on September 20, 2021, the entire disclosure of which is hereby incorporated by reference in its entirety.

[0003] For example, medical syringes, such as fillable syringes or pre - filled syringes, typically include a hollow body, or barrel, that forms a container for a medical product. This body includes a distal end that can optionally be provided with a needle and a proximal end that typically includes a flange.

[0004] Traceability of medical containers such as medical syringes has increasingly become necessary to be carried out individually from the manufacturing process through to final labeling, final use, and disposal.

[0005] To ensure traceability of medical syringes and the like, it is known to utilize machine - readable identifiers such as barcodes, QR codes (registered trademark), RFID tags, etc. However, such identifiers are often accessible from the surface of the container and are subject to damage and tampering. Further, the positions of many existing identifiers on the device are often not advantageous for effective and efficient scanning / reading.

[0006] Furthermore, in many existing solutions, it is necessary to attach RFID tags to various components of the syringe in the latter half of the manufacturing process, such as during product labeling. As a result, it is not possible to track the syringe during important pre - labeling processes such as during the filling operation.

[0007] Furthermore, existing RFID tags are susceptible to damage and contamination during normal handling of the syringe, particularly during inspection and cleaning operations. For example, existing RFID tags can be damaged by electric shock in a high voltage leakage detection station or by steam during EtO (ethylene oxide) and other autoclave sterilization procedures. SUMMARY OF THE INVENTION

[0008] In view of the above, there is a need for a syringe assembly with improved traceability, as well as additional features indicative of tampering.

[0009] Embodiments of the present disclosure are directed to a syringe assembly including a syringe having a reservoir and a distal tip, a cap component engaging the distal tip, and an identification sleeve engaging the cap component via one or more engagement features extending from at least one of the cap component and the identification sleeve. The identification sleeve includes an RFID tag.

[0010] In some embodiments, the RFID tag is embedded in the identification sleeve.

[0011] In some embodiments, the identification sleeve is rotatably locked to the cap component.

[0012] In some embodiments, the one or more engagement features include longitudinally extending ribs or splines.

[0013] In some embodiments, the one or more engagement features are equally spaced around the inner circumference of the identification sleeve.

[0014] In some embodiments, the identification sleeve is press fit or adhered to the cap component.

[0015] In some embodiments, the identification sleeve includes a flange that engages a proximal surface of the cap component to prevent the identification sleeve from sliding relative to the cap component.

[0016] In some embodiments, the flange defines an opening through which the distal tip extends.

[0017] In some embodiments, the identification sleeve includes one or more tabs that engage a proximal surface of the cap component to prevent the identification sleeve from sliding relative to the cap component. Each of the one or more tabs is configured to flex radially outwardly so that the identification sleeve can slide over the cap component during installation of the identification sleeve onto the cap component.

[0018] In some embodiments, each of the one or more tabs engages a distal end of the cap component and includes an inclined surface configured to flex the one or more tabs radially outwardly during attachment of the identification sleeve to the cap component.

[0019] In some embodiments, the identification sleeve is substantially the same length as the cap component in the longitudinal direction.

[0020] In some embodiments, the identification sleeve is longer than the cap component in the longitudinal direction.

[0021] In some embodiments, the syringe assembly further includes a cap that seals the distal tip. The identification sleeve at least partially surrounds the cap.

[0022] In some embodiments, at least a portion of the outer diameter of the identification sleeve is substantially equal to the outer diameter of the reservoir.

[0023] In some embodiments, the syringe assembly further includes a label adhered to the reservoir and the identification sleeve.

[0024] Other embodiments of the present disclosure relate to an identification sleeve of a syringe assembly. The identification sleeve includes one or more engagement features that extend radially inwardly from an inner surface of the identification sleeve. The one or more engagement features are configured to engage with one or more corresponding engagement features on a cap component of the syringe assembly. The identification sleeve includes an RFID tag.

[0025] In some embodiments, the RFID tag is embedded in the identification sleeve.

[0026] In some embodiments, one or more engagement features of the identification sleeve rotatably lock the identification sleeve to the cap component.

[0027] In some embodiments, the one or more engagement features include longitudinally extending ribs or splines.

[0028] In some embodiments, the one or more engagement features are equally spaced around an inner circumference of the identification sleeve.

[0029] In some embodiments, the identification sleeve is configured to be press-fitted onto the cap component.

[0030] In some embodiments, the identification sleeve includes a flange that extends radially inwardly from a proximal end of the identification sleeve. The flange is configured to engage with a proximal surface of the cap component to prevent the identification sleeve from sliding relative to the cap component.

[0031] In some embodiments, the flange defines an opening through which a distal tip of the syringe assembly extends.

[0032] In some embodiments, the identification sleeve includes one or more tabs configured to engage a proximal surface of the cap component to prevent the identification sleeve from sliding relative to the cap component. Each of the one or more tabs is configured to flex radially outwardly so that the identification sleeve can slide over the cap component during installation of the identification sleeve onto the cap component.

[0033] In some embodiments, each of the one or more tabs includes an inclined surface configured to engage a distal end of the cap component and to flex the one or more tabs radially outwardly during attachment of the identification sleeve to the cap component.

[0034] Further details and advantages of the various examples detailed herein will become apparent upon consideration of the following detailed description of the various examples in conjunction with the accompanying drawings.

Brief Description of the Drawings

[0035] The foregoing and other features and advantages of the present disclosure, and the manner in which they are achieved, will become more apparent and the present disclosure itself will be better understood by reference to the following description of embodiments of the present disclosure taken in conjunction with the accompanying drawings.

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[0036] Corresponding reference numerals indicate corresponding parts throughout the several views. The examples presented herein illustrate exemplary embodiments of the present disclosure and such examples should not be construed as limiting the scope of the present disclosure in any way.

DETAILED DESCRIPTION OF THE INVENTION

[0037] The following description is provided to enable one of ordinary skill in the art to make and use the described embodiments contemplated for carrying out the present disclosure. However, various modifications, equivalents, variations, and alternatives will remain readily apparent to one of ordinary skill in the art. Any and all such modifications, variations, equivalents, and alternatives are intended to fall within the spirit and scope of the present disclosure.

[0038] For purposes of explanation hereinafter, the terms "upper", "lower", "right", "left", "vertical", "horizontal", "uppermost", "lowermost", "lateral", "longitudinal", and derivatives thereof shall pertain to the present invention as oriented in the drawings. However, it will be understood that the present invention may contemplate various alternative variations unless explicitly specified to the contrary. It should also be understood that the specific devices shown in the accompanying 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 aspects disclosed herein should not be considered limiting.

[0039] All numbers used in this specification and the claims are to be understood as being modified in all instances by the term "about". The terms "approximately", "about", and "substantially" mean within plus or minus 10 percent of the recited value. Further, the term "substantially equal" and similar terms mean that the values or dimensions being compared are within plus or minus 10 percent of each other.

[0040] The terms "first", "second", and the like are not intended to refer to any particular order or time sequence, but rather to different conditions, characteristics, or elements.

[0041] As used herein with respect to an injection device such as a syringe, the term "proximal" refers to the end of the device that is furthest from the outlet, or the direction towards the end of the device that is furthest from the outlet. As used herein with respect to an injection device such as a syringe, the term "distal" refers to the end of the device or component that is closest to the outlet, or the direction towards the end of the device that is closest to the outlet.

[0042] As used herein, "at least one of" is synonymous with "one or more of". For example, the phrase "at least one of A, B, and C" means any one of A, B, or C, or any combination of two or more of A, B, or C. For example, "at least one of A, B, and C" includes one or more of A alone, or one or more of B alone, or one or more of C alone, or one or more of A and one or more of B, or one or more of A and one or more of C, or one or more of B and one or more of C, or one or more of A, B, and C all together.

[0043] Referring initially to FIG. 1, a syringe assembly 100 according to an embodiment of the present disclosure includes a syringe 1, a luer lock adapter 8, and an identification sleeve 20. The syringe 1 may include a reservoir 2 integrally connected to a distal tip 3. The reservoir 2 may have a tubular shape and define a chamber for holding a product such as a medical fluid. The reservoir 2 and the distal tip 3 may be made of a suitable sterile material such as glass or polymer. The reservoir 2 may be sealed at its proximal end by a piston and / or plunger (not shown), and the piston and / or plunger may be actuated distally along the longitudinal axis A of the reservoir 2 to expel the product from the reservoir 2. The distal tip 3 defines a lumen 4 through which the product may be expelled from the reservoir 2. The distal tip 3 may be configured to fluidly connect to other components (not shown) such as an intravenous (IV) connector or a needle hub to facilitate aseptic transfer of the product from the reservoir 2.

[0044] Referring now to FIGS. 2 and 3, the syringe assembly 100 is shown with the sleeve 20 removed to more clearly illustrate the features of the luer lock adapter 8. The luer lock adapter 8 includes a generally tubular ring 9 that at least partially surrounds the distal tip 3 of the syringe 1. The annular projection 10 extends radially inwardly from the proximal end of the ring 9 and engages the coupling portion 7 of the distal tip 3 of the syringe 1. In some embodiments, as shown in FIG. 7, the annular projection 10 may include a lip 15 configured to engage the distal side 14 of the coupling portion 7 of the distal tip 3 to prevent removal of the luer lock adapter 8 from the distal tip 3. In some embodiments, the luer lock adapter 8 may be freely rotatable about the longitudinal axis A with respect to the distal tip 3. In some embodiments, the luer lock adapter 8 may be rotatably locked to the distal tip 3, for example, by an interference fit between the annular projection 10 and the coupling portion 7.

[0045] Continuing to refer to FIGS. 2 and 3, the outer surface of the ring 9 of the luer lock adapter 8 may include one or more engagement features 12, such as splines or ribs. In some embodiments, the one or more engagement features 12 may include eight splines or ribs. Each of the engagement features 12 may generally extend longitudinally along the ring 9 parallel to the longitudinal axis A. The engagement features 12 may be equally or asymmetrically spaced around the circumference of the ring 9. The inner surface of the ring 9 may include an internal thread 11 configured to engage a connector (not shown), such as an IV connector or a needle hub, to make a sterile connection with the syringe 1 and facilitate the transfer of product from the syringe 1 to the connector or vice versa. The connector may include an external thread configured to cooperate with the internal thread 11 of the luer lock adapter 8 to screw the luer lock adapter 8 onto the connector.

[0046] Referring again to FIG. 1 and additionally to FIGS. 4 - 6, sleeve 20 may include a radio frequency identification (RFID) tag 30 (shown in FIGS. 5 - 6). By bringing the syringe assembly close to an RFID scanner (not shown), it can be used to identify and trace syringe assembly 100. Sleeve 20 includes one or more engagement features 22, such as splines or ribs, and has an inner surface 21 that extends radially inwardly toward longitudinal axis A. Each of the engagement features 22 may generally extend longitudinally along the inner surface 21 of sleeve 20 parallel to longitudinal axis A. In some embodiments, one or more engagement features 12 may include eight splines or ribs. The engagement features 22 may be equally or asymmetrically spaced around the inner circumference of sleeve 20. One or more engagement features 22 of sleeve 20 may be arranged and configured to engage with one or more engagement features 12 of adapter 8 to prevent rotation of sleeve 20 relative to adapter 8. For example, one or more engagement features 22 of sleeve 20 may be arranged to fit between adjacent engagement features 12 of luer lock adapter 8. In some embodiments, as described herein in connection with FIG. 7, sleeve 20 may have a press fit or interference fit with luer lock adapter 8 to prevent longitudinal movement of sleeve 20 relative to luer lock adapter 8. In some embodiments, sleeve 20 may be adhered to luer lock adapter 8 to prevent longitudinal movement of sleeve 20 relative to luer lock adapter 8. In some embodiments, as described herein in connection with FIGS. 8 - 11, sleeve 20 may include one or more retention features to prevent longitudinal movement of sleeve 20 relative to luer lock adapter 8. In some embodiments, sleeve 20 and / or luer lock adapter 8 may lack their respective engagement features 12, 22, allowing relative rotation between sleeve 20 and luer lock adapter 8.

[0047] As shown in FIG. 5, the RFID tag 30 can be in the form of a rolled sheet forming a complete or partial circle, but this shape is merely illustrative and other shapes are possible. The RFID tag 30 can be in any form factor such as a laminated inlay or a hard tag encapsulated in resin. In some embodiments as shown in FIG. 6, the RFID tag 30 can be embedded in the sleeve 20 during the molding process. By molding the RFID tag 30 into the sleeve 20, the RFID tag can be protected from damage and contamination during normal handling of the syringe assembly 100, particularly during inspection and cleaning operations. For example, molding the RFID tag 30 into the sleeve 20 can protect the RFID tag 30 from electric shock at a high voltage leakage detection station and from steam during EtO (ethylene oxide) and other autoclave sterilization procedures. In some embodiments, the sleeve 20 can be formed of a thermoplastic polymer such as polypropylene or polyethylene, molded at a temperature and pressure low enough so that the RFID tag 30 is not damaged during the molding process. In some embodiments, the sleeve 20 can be extruded over the RFID tag 30. In some embodiments, the RFID tag 30 can be applied to the outer surface 28 or the inner surface 21 of the sleeve 20 after the sleeve 20 is molded.

[0048] The RFID tag 30 can use any available frequency band, such as ultra-high frequency (UHF), high frequency (HF), high frequency near field communication (HF-NFC), low frequency (LF), Bluetooth® low energy (BLE), and / or LoRaWan. Although the RFID tag 30 is shown and described herein, it should be understood that other forms of remotely writable and readable data tags and / or inlays can be utilized in accordance with the present disclosure. For example, data tags or inlays such as Bluetooth tags, ultra-wideband real-time location systems (RTLS), WiFi® RTLS, and / or infrared RTLS can be utilized instead of (or in addition to) the RFID tag 30.

[0049] Next, referring to FIGS. 7-11, various connection mechanisms between the sleeve 20 and the luer lock adapter 8 are shown. First, referring to FIG. 7, in some embodiments, the sleeve 20 can be fixed to the luer lock adapter 8 via an interference fit (which can also be referred to as a press fit or friction fit). That is, the inner diameter of the sleeve 20 may be smaller than the outer diameter of the luer lock adapter 8 such that friction holds the sleeve 20 in a predetermined position relative to the luer lock adapter 8. In some embodiments, one or more of the engagement features 22 of the sleeve 20 can have an interference fit between corresponding engagement features 12 of the luer lock adapter 8. In some embodiments, the interference fit between the sleeve 20 and the luer lock adapter 8 can be sufficient to prevent the sleeve 20 from slipping off the luer lock adapter 8 under normal forces associated with the handling and use of the syringe assembly 100. In some embodiments, the interference fit between the sleeve 20 and the luer lock adapter 8 can be complemented by other retention features as described herein in connection with FIGS. 8-11.

[0050] Next, referring to FIGS. 8-9, in some embodiments, the sleeve 20 can include a flange 23 that extends radially inwardly from the proximal end 24 of the sleeve 20. The flange 23 can define an opening 25 that is small enough such that the distal tip 3 of the syringe 1 can extend through the opening 25, but the luer lock adapter 8 cannot fit through the opening 25. As shown in FIG. 9, the flange 23 abuts against the proximal face of the luer lock adapter 8 when attached to prevent the sleeve 20 from sliding distally relative to the luer lock adapter 8. During assembly of the syringe assembly 100, the luer lock adapter 8 can be inserted into the sleeve 20, and the subassembly of the luer lock adapter 8 and the sleeve 20 can then be attached as a unit to the distal tip 3 of the syringe 1. Alternatively, the sleeve 20 can be positioned at a predetermined position on the distal tip 3, and the luer lock adapter 8 can then be attached on the distal tip 3 and within the sleeve 20.

[0051] Next, referring to FIGS. 10-11, in some embodiments, the proximal end 24 of the sleeve 20 may include one or more tabs 26 configured to engage the proximal surface of the luer lock adapter 8. Each of the tabs 26 may include an inclined surface 27 configured to enable attachment of the sleeve 20 over the luer lock adapter 8. In particular, the sleeve 20 may be attached by sliding the sleeve 20 proximally over the luer lock adapter 8 with the luer lock adapter 8 already attached to the distal tip 3. The inclined surface 27 of each tab 26 engages the distal end of the luer lock adapter 8 and deflects the tab 26 radially outward to clear the luer lock adapter 8 and enable the sleeve 20 to slide over the luer lock adapter 8. When the sleeve 20 reaches a predetermined position such that the tab 26 is proximal to the luer lock adapter 8, the tab 26 deflects inward to engage the proximal surface of the luer lock adapter 8. Thus, the tab 26 facilitates a snap-fit connection between the sleeve 20 and the luer lock adapter 8. Once the sleeve 20 is attached and the tab 26 engages the proximal surface of the luer lock adapter 8, the tab 26 prevents the sleeve 20 from sliding distally relative to the luer lock adapter 8.

[0052] In some embodiments, one or more of the various connection mechanisms shown in FIGS. 7-11 may be used in combination with each other to enhance the connection between the sleeve 2 and the luer lock adapter 8.

[0053] In the embodiments shown in FIGS. 1-11, the sleeve 20 is substantially the same length as the luer lock adapter 8 in a longitudinal direction parallel to the longitudinal axis A. In other embodiments, the sleeve 20 may be longer or shorter than the luer lock adapter 8. For example, as shown in the embodiments of FIGS. 12-13, the sleeve 20 may be longer than the luer lock adapter 8 such that the sleeve 20 extends distally beyond the luer lock adapter 8. The sleeve 20 may at least partially surround a sealing cap 32, e.g., a rigid tip cap (RC) including an elastomeric rigid tip cap (RITC) that seals the distal tip 3 of the syringe 1. Collectively, the luer lock adapter 8 and the sealing cap 32 (including the RC and the RITC) may be referred to as a plastic rigid tip cap (PRTC). Thus, the sleeve 20 prevents removal of the cap 32 unless the sleeve 20 itself is removed or tampered with. Such tampering is evident upon visual inspection of the syringe assembly 100, thereby warning the user not to use the syringe assembly 100.

[0054] Referring now to FIG. 14, in some embodiments, the sleeve 20 may extend proximally of the luer lock adapter 8. This configuration reduces the gap G between the sleeve 20 and the reservoir 2 and makes the syringe assembly 100 easier to handle. Further, reduction of the gap G may facilitate a more reliable placement of a label on the syringe assembly 100 as described herein in connection with FIGS. 15-16. In the embodiments shown in the accompanying drawings, the proximal end 24 of the sleeve 20 (e.g., as shown in FIGS. 9, 11, and 14) may terminate distally of the reservoir 2, which may be advantageous in that the sleeve 20 does not interfere with visual inspection (either manual or mechanical) of the syringe 1.

[0055] Note that FIGS. 12-14 show the sleeve 20 without the flange 23 of FIGS. 8-9 or the tab 26 of FIGS. 10-11. However, those skilled in the art should understand that in the embodiments shown in FIGS. 12-14, the flange 23 and / or the tab 26 can be easily implemented. Such modifications should be considered within the scope of the present disclosure.

[0056] Referring now to FIGS. 15-16, in some embodiments, the label 40 can be applied to the syringe assembly 100. The label 40 can be attached to the reservoir 2 and the sleeve 20 and can include an adhesive backing that extends across the gap G. To facilitate the placement of the label 40, at least a portion of the outer diameter of the sleeve 20 can be substantially equal to the outer diameter of the reservoir 2. Further, the outer surface 28 of the sleeve 20 can be substantially smooth to promote adhesion and be less susceptible to contamination. The label 40 can extend at least partially around the circumference of the reservoir 2 and the sleeve 20. With the label 40 fixed to both the sleeve 20 and the reservoir 2, the label 40 prevents the sleeve 20 from rotating relative to the reservoir 2. As a result, the luer lock adapter 8 is also prevented from rotating relative to the reservoir 2 due to the engagement between the luer lock adapter 8 and the sleeve 20. This has the advantage that the luer lock adapter 8 is firmly connected to the syringe 1, which enhances the user's confidence that the assembly 100 is safe and sterile. The label 40 can be configured to tear to indicate to the user that the syringe assembly 100 has been opened when sufficient rotational force is applied to the sleeve 20, i.e., when the user twists the sleeve 20 to open the syringe assembly 100. In some embodiments, the label 40 can also be adhered to the cap 32 (shown in FIG. 14). The label 40 can be configured to tear when the cap 32 is removed, indicating to the user that the syringe assembly 100 has been opened. In some embodiments, the label 40 can include an RFID tag (not shown) to enable additional monitoring and tracking of the syringe assembly 100.

[0057] The sleeve 20 can be attached to the luer lock adapter 8 at various stages of the life of the syringe assembly 100 to improve the traceability of the syringe assembly 100 compared to conventional methods. For example, the sleeve 20 can be connected to the luer lock adapter 8 during the assembly process of the cap 32. Alternatively, the sleeve 20 can be connected to the luer lock adapter 8 after the cap 32 is connected to the syringe 1. These options enable the traceability of the "naked" (i.e., unfilled) syringe assembly 100 using the RFID tag 30. Alternatively, the sleeve 20 can be connected to the luer lock adapter 8 before attaching the label 40.

[0058] The embodiments described and illustrated above show a sleeve 20 for use with an embodiment of a syringe assembly 100 that includes a luer lock adapter 8. However, it should be understood that the sleeve 20 can also be used with an embodiment of a syringe assembly 100 that includes a rigid needle shield (RNS). In particular, one or more engagement features 22 of the sleeve 20 can be configured to engage one or more engagement features of the RNS, which can be similar to one or more engagement features 12 of the luer lock adapter 8 described herein. As used herein, the term "cap component" means any form or component of a cap for the syringe assembly 100 that engages the distal tip 3 of the syringe 1, regardless of whether the cap is a PRTC or an RNS. In certain embodiments, the term "cap component" can refer to the outer component of the luer lock adapter 8 or the RNS.

[0059] The present invention has been described in detail for purposes of illustration based on what is currently considered to be the most practical and preferred embodiments or aspects, but such details are for that purpose only, and it is to be understood that the present invention is not limited to the disclosed embodiments or aspects, 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 invention 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.

[0060] The present invention includes the following embodiments: [Configuration 1] A syringe assembly comprising: A syringe having a reservoir and a distal tip; A cap component that engages with the distal tip; An identification sleeve that engages with the cap component via one or more engagement features extending from at least one of the cap component and the identification sleeve; And comprising: The identification sleeve comprises an RFID tag, the syringe assembly. [Configuration 2] The RFID tag is embedded in the identification sleeve, the syringe assembly according to Configuration 1. [Configuration 3] The syringe assembly according to Configuration 1 or 2, wherein the identification sleeve is rotatably locked to the cap component. [Configuration 4] The syringe assembly according to any one of Configurations 1 to 3, wherein the one or more engagement features comprise longitudinally extending ribs or splines. [Configuration 5] The syringe assembly according to any one of Configurations 1 to 4, wherein the one or more engagement features are equally spaced around the inner circumference of the identification sleeve. [Configuration 6] The syringe assembly according to any one of Configurations 1 to 5, wherein the identification sleeve is press-fitted or adhered to the cap component. [Configuration 7] The syringe assembly according to any one of Configurations 1 to 6, wherein the identification sleeve includes a flange that engages with the proximal surface of the cap component to prevent the identification sleeve from sliding relative to the cap component. [Configuration 8] The syringe assembly according to Configuration 7, wherein the flange defines an opening through which the distal tip extends. [Configuration 9] The identification sleeve includes one or more tabs that engage with the proximal surface of the cap component to prevent the identification sleeve from sliding relative to the cap component, Each of the one or more tabs is configured to flex radially outwardly to allow the identification sleeve to slide over the cap component during installation of the identification sleeve on the cap component, the syringe assembly according to any one of Configurations 1 to 8. [Configuration 10] Each of the one or more tabs is configured with an inclined surface that engages with the distal end of the cap component and deflects the one or more tabs radially outwardly during attachment of the identification sleeve to the cap component, the syringe assembly according to Configuration 9. [Configuration 11] The syringe assembly according to any one of Configurations 1 to 10, wherein the identification sleeve is substantially the same length as the cap component in the longitudinal direction. [Configuration 12] The syringe assembly according to any one of Configurations 1 to 10, wherein the identification sleeve is longer than the cap component in the longitudinal direction. [Configuration 13] Further comprising a cap for sealing the distal tip, The syringe assembly according to any one of Configurations 1 to 12, wherein the identification sleeve at least partially surrounds the cap. [Configuration 14] The syringe assembly according to any one of Configurations 1 to 13, wherein at least a portion of the outer diameter of the identification sleeve is substantially equal to the outer diameter of the reservoir. [Configuration 15] The syringe assembly according to any one of Configurations 1 to 14, further comprising a label adhered to the reservoir and the identification sleeve.

Claims

**Claim 1** A syringe assembly comprising a syringe having a reservoir and a distal tip, a cap component that engages with the distal tip, an identification sleeve that engages with the cap component via one or more engagement features extending from at least one of the cap component and the identification sleeve; wherein the identification sleeve comprises an RFID tag, the syringe assembly. **Claim 2** The syringe assembly according to claim 1, wherein the RFID tag is embedded in the identification sleeve. **Claim 3** The syringe assembly according to claim 1, wherein the identification sleeve is rotatably locked to the cap component. **Claim 4** The syringe assembly according to claim 1, wherein the one or more engagement features comprise longitudinally extending ribs or splines. **Claim 5** The syringe assembly according to claim 1, wherein the one or more engagement features are equally spaced around the inner circumference of the identification sleeve. **Claim 6** The syringe assembly according to claim 1, wherein the identification sleeve is press-fitted or adhered to the cap component. **Claim 7** The syringe assembly according to claim 1, wherein the identification sleeve includes a flange that engages with the proximal face of the cap component to prevent the identification sleeve from sliding relative to the cap component. **Claim 8** The syringe assembly according to claim 7, wherein the flange defines an opening through which the distal tip extends. **Claim 9** The identification sleeve includes one or more tabs that engage with the proximal face of the cap component to prevent the identification sleeve from sliding relative to the cap component, and each of the one or more tabs is configured to flex radially outwardly to allow the identification sleeve to slide over the cap component during installation of the identification sleeve onto the cap component, the syringe assembly according to claim 1. **Claim 10** The syringe assembly according to claim 9, wherein each of the one or more tabs engages with the distal end of the cap component and includes an inclined surface configured to flex the one or more tabs radially outwardly during attachment of the identification sleeve to the cap component.

11. The syringe assembly according to claim 1, wherein the identification sleeve is substantially the same length as the cap component in the longitudinal direction.

12. The syringe assembly according to claim 1, wherein the identification sleeve is longer than the cap component in the longitudinal direction.

13. Further comprising a cap for sealing the distal tip, The syringe assembly according to claim 1, wherein the identification sleeve at least partially surrounds the cap.

14. The syringe assembly according to claim 1, wherein at least a part of the outer diameter of the identification sleeve is substantially equal to the outer diameter of the reservoir.

15. The syringe assembly according to claim 1, further comprising a label adhered to the reservoir and the identification sleeve.

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