Syringe Assembly with In-Molded RFID Sleeve

A syringe assembly includes a syringe having a reservoir and a distal tip, a cap component engaged with the distal tip, and an identification sleeve engaged with 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 comprises an RFID tag to allow the traceability of said syringe before final product labelling.

CROSS-REFERENCE TO RELATED APPLICATION

The present application claims priority to European Patent Application No. 21306295.3, entitled “Syringe Assembly with In-Molded RFID Sleeve”, filed Sep. 20, 2021, the entire disclosure of which is hereby incorporated by reference in its' entirety.

BACKGROUND OF THE INVENTION

Field of the Invention

The present disclosure relates to medical injection devices utilizing data tags or inlays, such as radio frequency identification (RFID) tags or inlays

Description of Related Art

Medical injection devices such as, e.g., pre-fillable or prefilled syringes usually include a hollow body or barrel forming a container for a medical product. This body includes a distal end which optionally may be provided with a needle, and a proximal end, usually provided with a flange.

There is an increasing need for individual traceability of medical containers such as medical injection devices, with such traceability extending from the manufacturing process until the final labeling, final use, and/or disposal of the medical containers.

While it has been known to utilize machine-readable identifiers such as bar codes, QR codes, and/or RFID tags in order to provide traceability of products such as, e.g., medical injection devices, such identifiers are often accessible from the surface of the containers or other devices, making the identifiers potentially subject to damage or tampering. Additionally, the location of many existing identifiers on the devices is often not conducive to effective and efficient scanning/reading.

Furthermore, many existing solutions call for the RFID tags to be attached to various components of the syringes late in the manufacturing process, such as during product labelling. This does not allow for the syringes to be traced during important pre-labelling processes, such as during filling operations.

Still further, existing RFID tags are susceptible to damage and contamination during normal handling of the syringes, and particularly during inspection and cleaning operations. For example, existing RFID tags can be damaged by electric shock at high voltage leak detection stations, or by steam during EtO (ethylene oxide) and other autoclave sterilization procedures.

SUMMARY

In view of the foregoing, there exists a need for syringe assemblies having improved traceability, as well as additional features to indicate tampering.

Embodiments of the present disclosure are directed to a syringe assembly including a syringe having a reservoir and a distal tip, a cap component engaged with the distal tip, and an identification sleeve engaged with 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.

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

In some embodiments, the identification sleeve is rotationally locked to the cap component.

In some embodiments, the one or more engagement features includes a rib or spline extending in a longitudinal direction.

In some embodiments, the one or more engagement features are equally spaced about an inside circumference of the identification sleeve.

In some embodiments, the identification sleeve is press fit or glued onto the cap component.

In some embodiments, the identification sleeve includes a flange engaging a proximal face of the cap component to prevent the identification sleeve from sliding relative to the cap component.

In some embodiments, the flange defines an aperture through which the distal tip extends.

In some embodiments, the identification sleeve includes one or more tabs engaging a proximal face 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 deflect radially outward to allow the identification sleeve to slide over the cap component during installation of the identification sleeve onto the cap component.

In some embodiments, each of the one or more tabs includes a ramped surface configured to engage a distal end of the cap component and cause the one or more tabs to deflect radially outward during installation of the identification sleeve onto the cap component.

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

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

In some embodiments, the syringe assembly further includes a cap sealing the distal tip. The identification sleeve at least partially surrounds the cap.

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

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

Other embodiments of the present disclosure are directed to an identification sleeve for a syringe assembly. The identification sleeve includes one or more engagement features extending radially inward from an inner surface of the identification sleeve. The one or more engagement features are configured to engage one or more corresponding engagement features on a cap component of the syringe assembly. The identification sleeve includes an RFID tag.

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

In some embodiments, the one or more engagement features of the identification sleeve rotationally lock the identification sleeve to the cap component.

In some embodiments, the one or more engagement features includes a rib or spline extending in a longitudinal direction.

In some embodiments, the one or more engagement features are equally spaced about an inside circumference of the identification sleeve.

In some embodiments, the identification sleeve is configured to be press fit onto the cap component.

In some embodiments, the identification sleeve includes a flange extending radially inward from a proximal end of the identification sleeve. The flange is configured to engage a proximal face of the cap component to prevent the identification sleeve from sliding relative to the cap component.

In some embodiments, the flange defines an aperture through which a distal tip of the syringe assembly extends.

In some embodiments, the identification sleeve includes one or more tabs configured to engage a proximal face 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 deflect radially outward to allow the identification sleeve to slide over the cap component during installation of the identification sleeve onto the cap component.

In some embodiments, each of the one or more tabs includes a ramped surface configured to engage a distal end of the cap component and cause the one or more tabs to deflect radially outward during installation of the identification sleeve onto the cap component.

Further details and advantages of the various examples described in detail herein will become clear upon reviewing the following detailed description of the various examples in conjunction with the accompanying drawing figures.

DETAILED DESCRIPTION

All numbers used in the specification and claims are to be understood as being modified in all instances by the term “about”. The terms “approximately”, “about”, and “substantially” mean a range of plus or minus ten percent of the stated value. Further, the term “substantially equal” and like terms mean that the compared values or dimensions are within a range of plus or minus ten percent of one another.

The terms “first”, “second”, and the like are not intended to refer to any particular order or chronology, but refer to different conditions, properties, or elements.

As used herein with reference to an injection apparatus such as a syringe, the term “proximal” refers to an end of the apparatus farthest from the outlet, or to a direction toward the end of the apparatus farthest from the outlet. As used herein with reference to an injection apparatus such as a syringe, the term “distal” refers to an end of the device or apparatus closest to the outlet, or to a direction toward the end of the apparatus closest to the outlet.

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 any 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 all of A, B, and C.

Referring first toFIG.1, a syringe assembly100according to embodiments of the present disclosure includes a syringe1, a luer lock adapter8, and an identification sleeve20. The syringe1may include a reservoir2integrally connected to a distal tip3. The reservoir2may have a tubular shape and defines a chamber for holding a product, such as a medical fluid. The reservoir2and the distal tip3may be made a suitable, sterile material, such as a glass or polymer. The reservoir2may be sealed at its proximal end by a piston and/or plunger (not shown), that can be actuated distally along a longitudinal axis A of the reservoir2to expel the product from the reservoir2. The distal tip3defines a lumen4through which the product can be expelled from the reservoir2. The distal tip3may be configured for fluid connection to other components (not shown), such as an intravenous (IV) connector or needle hub, to facilitate sterile transfer of the product from the reservoir2.

Referring now toFIGS.2and3, the syringe assembly100is illustrated with the sleeve20removed to more clearly illustrate the features of the luer lock adapter8. The luer lock adapter8includes a generally tubular ring9that at least partially surrounds the distal tip3of the syringe1. An annular projection10extends radially inward from a proximal end of the ring9to engage a coupling portion7of the distal tip3of the syringe1. In some embodiments, as shown inFIG.7, the annular projection10may include a lip15configured to engage a distal side14of the coupling portion7of the distal tip3to prevent removal of the luer lock adapter8from the distal tip3. In some embodiments, the luer lock adapter8may be free to rotate about the longitudinal axis A relative to the distal tip3. In some embodiments, the luer lock adapter8may be rotationally locked to the distal tip3by, for example, an interference fit between the annular projection10and the coupling portion7.

With continued reference toFIGS.2and3, an external surface of the ring9of the luer lock adapter8may include one or more engagement features12, such a splines or ribs. In some embodiments, the one or more engagement features12may include eight splines or ribs. Each of the engagement features12may extend generally longitudinally along the ring9parallel to the longitudinal axis A. The engagement feature12may be equally or asymmetrically spaced about the circumference of the ring9. An internal surface of the ring9may include an internal thread11configured to engage a connector (not shown), such as an IV connector or a needle hub, in order to make a sterile connection with the syringe1and facilitate transfer of the product from the syringe1to the connector or vice-versa. The connector may be provided with an external thread configured to cooperate with the internal thread11of the luer lock adapter8in order to screw the luer lock adapter8onto the connector.

Referring again toFIG.1and additionally toFIGS.4-6, the sleeve20may include a radiofrequency identification (RFID) tag30(shown inFIGS.5-6) that can be used to identify and trace the syringe assembly100by bringing the syringe assembly into proximity to an RFID scanner (not shown). The sleeve20has an internal surface21including one or more engagement features22, such as splines or ribs, extending radially inward toward the longitudinal axis A. Each of the engagement features22may extend generally longitudinally along the inner surface21of the sleeve20parallel to the longitudinal axis A. In some embodiments, the one or more engagement features12may include eight splines or ribs. The engagement feature22may be equally or asymmetrically spaced about the inside circumference of the sleeve20. The one or more engagement features22of the sleeve20may be arranged and configured to engage the one or more engagement features12of the adapter8to prevent rotation of the sleeve20relative to the adapter8. For example, the one or more engagement features22of the sleeve20may be arranged to fit between adjacent engagement features12of the luer lock adapter8. In some embodiments, as will be described herein in connection withFIG.7, the sleeve20may have a press fit or interference fit with the luer lock adapter8to prevent longitudinal movement of the sleeve20relative to the luer lock adapter8. In some embodiments, the sleeve20may be glued to the luer lock adapter8to prevent longitudinal movement of the sleeve20relative to the luer lock adapter8. In some embodiments, as will be described herein in connection withFIGS.8-11, the sleeve20may include one or more retaining features to prevent longitudinal movement of the sleeve20relative to the luer lock adapter8. In some embodiments, the sleeve20and/or the luer lock adapter8may lack their respective engagement features12,22, allowing relative rotation between the sleeve20and the luer lock adapter8.

As shown inFIG.5, the RFID tag30may be in the form of a rolled sheet forming a complete or partial circle, though this shaped is only illustrative and other shapes are possible. The RFID tag30may be in any form factor such as a laminated inlay or a hard tag encased in resin. In some embodiments as shown inFIG.6, the RFID tag30may be embedded in the sleeve20during a molding process. By molding the RFID tag30into the sleeve20, the RFID tag may be protected from damage and contamination during normal handling of the syringe assembly100, and particularly during inspection and cleaning operations. For example, molding the RFID tag30into the sleeve20may protect the RFID tag30from electric shock at high voltage leak detection stations, and from steam during EtO (ethylene oxide) and other autoclave sterilization procedures. In some embodiments, the sleeve20may be formed of a thermoplastic polymer, such as polypropylene or polyethylene, molded at a temperature and pressure sufficiently low so that the RFID tag30is not damaged during the molding process. In some embodiments, the sleeve20may be extrusion molded over the RFID tag30. In some embodiments, the RFID tag30may be applied to an outer surface28or to the inner surface21of the sleeve20after the sleeve20has be molded.

The RFID tag30may use any available frequency band, e.g., ultra-high frequency (UHF), high frequency (HF), high frequency-near-field communication (HF-NFC), low frequency (LF), Bluetooth low energy (BLE), and/or a low range wireless (LoRaWan). While RFID tag30is shown and described herein, it is to be understood that other forms of remotely writable and readable data tags and/or inlays may be utilized in accordance with the present disclosure. For example, data tags or inlays such as Bluetooth tags, an ultra-wide-band real-time location system (RTLS), a WiFi RTLS, and/or an infrared RTLS may be utilized in lieu of (or in addition to) the RFID tag30.

Referring now toFIGS.7-11, various connection mechanisms between the sleeve20and the luer lock adapter8are illustrated. Referring first toFIG.7, in some embodiments, the sleeve20may be secured to the luer lock adapter8via an interference fit (which may also be referred to as a press fit or a friction fit). That is, an inner diameter of the sleeve20may be less than an outer diameter of the luer lock adapter8, such that friction holds the sleeve20in place relative to the luer lock adapter8. In some embodiments, the one or more of the engagement features22of the sleeve20may have an interference fit between corresponding engagement features12of the luer lock adapter8. In some embodiments, the interference fit between the sleeve20and luer lock adapter8may be sufficient to prevent the sleeve20from sliding off of the luer lock adapter8under normal forces associated with handling and use of the syringe assembly100. In some embodiments, the interference fit between the sleeve20and the luer lock adapter8may be supplemented by other retaining features, such as described herein in connection withFIGS.8-11.

Referring now toFIGS.8-9, in some embodiments, the sleeve20may include a flange23extending radially inward from a proximal end24of the sleeve20. The flange23may define an aperture25large enough that the distal tip3of the syringe1may extend through the aperture25, but small enough that the luer lock adapter8cannot fit through the aperture25. As shown, inFIG.9, the flange23abuts a proximal face of the luer lock adapter8when installed to prevent the sleeve20from sliding distally relative to the luer lock adapter8. During assembly of the syringe assembly100, the luer lock adapter8may be inserted into the sleeve20, and the subassembly of the luer lock adapter8and the sleeve20may then be installed as a unit onto the distal tip3of the syringe1. Alternatively, the sleeve20may be positioned in place on the distal tip3, the luer lock adapter8may then be installed onto the distal tip3and into the sleeve20.

Referring now toFIGS.10-11, in some embodiments, the proximal end24of the sleeve20may include one or more tabs26configured to engage the proximal face of the luer lock adapter8. Each of the tabs26may include a ramped surface27configured to allow installation of the sleeve20over the luer lock adapter8. In particular, the sleeve20may be installed with the luer lock adapter8already installed on the distal tip3by sliding the sleeve20in a proximal direction over the luer lock adapter8. The ramped surface27of each tab26engages the distal end of the luer lock adapter8, causing the tabs26to deflect radially outward to clear the luer lock adapter8and allow the sleeve20to slide over the luer lock adapter8. Once the sleeve20is in position such that the tabs26are proximal of the luer lock adapter8, the tabs26deflect back inward to engage the proximal face of the luer lock adapter8. Thus, the tabs26facilitate a snap-fit connection between the sleeve20and the luer lock adapter8. With the sleeve20installed and the tabs26engaging the proximal face of the luer lock adapter8, the tabs26prevent the sleeve20from sliding distally relative to the luer lock adapter8.

In some embodiments, one or more of the various connection mechanisms shown inFIGS.7-11may be used in combination with one another to enhance the connection between the sleeve20and the luer lock adapter8.

In the embodiments shown inFIGS.1-11, the sleeve20is substantially the same length as the luer lock adapter8in a longitudinal direction parallel to the longitudinal axis A. In other embodiments, the sleeve20may be longer or shorter than the luer lock adapter8. For example, as shown in the embodiments ofFIGS.12-13, the sleeve20may be longer than the luer lock adapter8such that the sleeve20extends distally beyond the luer lock adapter8. The sleeve20may at least partially surround a sealing cap32, e.g. a rigid tip cap (RC) containing an elastomer rigid tip cap (RITC), sealing the distal tip3of the syringe1. Collectively, the luer lock adapter8and the sealing cap32(including the RC and the RITC) may be referred to as plastic rigid tip cap (PRTC). The sleeve20thus prevents removal of the cap32unless the sleeve20itself is removed or tampered with. Such tampering will be apparent upon visual inspection of the syringe assembly100, thereby alerting a user to not use the syringe assembly100.

Referring now toFIG.14, in some embodiments, the sleeve20may extend proximally of the luer lock adapter8. This arrangement reduces a gap G between the sleeve20and the reservoir2, making the syringe assembly100easier to handle. Additionally, reduction of the gap G may facilitate more reliable placement of a label over the syringe assembly100, as will be described herein in connection withFIGS.15-16. In the embodiments depicted in the accompanying drawings, the proximal end24(as shown, for example, inFIGS.9,11, and14) of the sleeve20may terminate distally of the reservoir2, which may be advantageous in that the sleeve20does not interfere with visual inspection (either manual or machine) of the syringe1.

It is noted that the illustrations ofFIGS.12-14show the sleeve20without the flange23ofFIGS.8-9or the tabs26ofFIGS.10-11. It is to be understood, however, that one skilled in the art could readily implement the flange23and/or tabs26in the embodiments shown inFIGS.12-14, and such variations are to be considered within the scope of the present disclosure.

Referring now toFIGS.15-16, in some embodiments, a label40may be applied to the syringe assembly100. The label40may include an adhesive backing that is attached to the reservoir2and the sleeve20, and extends across the gap G. To facilitate placement of the label40, at least a portion of an outer diameter of the sleeve20may be substantially equal to an outer diameter of the reservoir2. Additionally, the outer surface28of the sleeve20may be substantially smooth to promote adhesion and be less susceptible to contamination. The label40may extend at least partially around the circumference of the reservoir2and the sleeve20. With the label40secured to both the sleeve20and the reservoir2, the label40prevents the sleeve20from rotating relative to the reservoir2. Consequently, the luer lock adapter8is also prevented from rotating relative to the reservoir2due to the engagement between the luer lock adapter8and the sleeve20. This has the advantage that the luer lock adapter8is firmly connected to the syringe1, which increases user confidence that the assembly100is secure and sterile. The label40may be configured to tear when sufficient rotational force is exerted on the sleeve20, i.e. when the user twists the sleeve20to open the syringe assembly100, indicating to the user that the syringe assembly100has been opened. In some embodiments, the label40may also be adhered to the cap32(shown inFIG.14). The label40may be configured to tear when the cap32is removed, indicating to the user that the syringe assembly100has been opened. In some embodiments, the label40may include an RFID tag (not shown) to allow for additional monitoring and tracking of the syringe assembly100.

The sleeve20may be installed to the luer lock adapter8at various stages in the life of the syringe assembly100to enhance traceability of the syringe assembly100compared to traditional methods. For example, the sleeve20may be connected to the luer lock adapter8during an assembly process of the cap32. Alternatively, the sleeve20may be connected to the luer lock adapter8after the cap32is connected to the syringe1. These options allow for traceability of the “naked” (i.e. unfilled) syringe assembly100using the RFID tag30. Alternatively, the sleeve20may be connected to the luer lock adapter8prior to installation of the label40.

The above-described and illustrated embodiments illustrate the sleeve20being used with embodiments of the syringe assembly100that include a luer lock adapter8. However, it is to be understood that the sleeve20could also be used with embodiments of the syringe assembly100that include a rigid needle shield (RNS). In particular, the one or more engagement features22of the sleeve20could be configured to engage with one or more engagement features of the RNS, which could be similar to the one or engagement features12of the luer lock adapter8described herein. As used herein, the term “cap component” means a component of any form or cap for the syringe assembly100engaged with the distal tip3of the syringe1, regardless of whether the cap is a PRTC or RNS. In particular embodiments, the term “cap component” may refer to the luer lock adapter8or an outer component of an RNS.