Syringe rigid needle shield with RFID tag and foldable antenna
The rigid needle shield assembly with an RFID tag and antenna legs addresses the issue of damage and readability in medical devices, ensuring reliable tracking from production to disposal.
Patent Information
- Application Number
- JP2024543281
- Authority / Receiving Office
- JP · JP
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2022-01-21
- Filing Date
- 2023-01-20
- Publication Date
- 2025-02-04
AI Technical Summary
Existing medical injection devices lack effective and tamper-proof tracking solutions, particularly for RFID tags, which are often damaged or unreadable during manufacturing, use, and disposal processes.
A rigid needle shield assembly incorporating an RFID tag with antenna legs between internal and external walls, protecting the tag from damage and ensuring readability, using materials like polypropylene and elastomers to house the tag and maximize reading range.
The RFID tag within the rigid needle shield assembly provides robust tracking capabilities, maintaining readability and integrity from manufacturing to disposal, enhancing the reliability of medical device tracking.
Smart Images
Figure 2025503777000001_ABST
Abstract
Description
[Technical field]
[0001] The present disclosure relates to medical injection devices (e.g., syringes) that utilize a rigid needle shield (RNS) having a radio frequency identification (RFID) tag and a foldable antenna disposed therein, including methods of manufacturing such devices. [Background technology]
[0002] For example, a medical injection device, such as a prefillable or prefilled syringe, typically includes a hollow body or barrel that forms a container for the pharmaceutical product. The body includes a distal end, where a needle may optionally be provided, and a proximal end, where a flange is typically provided.
[0003] There is an increasing need for individual traceability of medical containers, such as medical injection devices, from the manufacturing process through to the final labeling, final use and / or disposal of the medical container.
[0004] For example, it is known to utilize machine-readable identifiers such as bar codes, QR codes, and / or RFID tags to provide traceability of products such as syringes, however, such identifiers are often accessible from the surface of the container or other device, and in some cases, are subject to being damaged or tampered with. Additionally, the location of many existing identifiers on the device is often not conducive to effective and efficient scanning / reading. Summary of the Invention
[0005] In view of the foregoing, a need exists for traceable identifiers, such as RFID tags, that may be resistant to damage and / or tampering and / or provide improved machine readability. There is also a need for tracking medical devices from the manufacturing step to the disposal step of the medical device.
[0006] An embodiment of the present disclosure is directed to a rigid needle shield assembly for covering a needle of a syringe. The rigid needle shield assembly includes a rigid shield having an open proximal end, a distal end, an exterior sidewall, and an interior sidewall. The rigid needle shield assembly also includes a flexible needle sheath having an open proximal end, a closed distal end, an exterior sidewall, and an interior sidewall. Additionally, the rigid needle shield assembly includes an RFID tag having at least a first antenna leg and a second antenna leg, the flexible needle sheath and the RFID tag are disposed within the rigid shield, the RFID tag being disposed between the interior sidewall of the rigid shield and the exterior sidewall of the flexible needle sheath. Furthermore, the first antenna leg and the second antenna leg extend along the length of the rigid shield between the interior sidewall of the rigid shield and the exterior sidewall of the flexible needle sheath.
[0007] In some embodiments, the RFID tag includes a dipole antenna.
[0008] In some embodiments, the RFID tag includes an integrated circuit coupled to a substrate.
[0009] In some embodiments, the first antenna leg and the second antenna leg are coupled to a substrate and are bendable relative to the substrate.
[0010] In some embodiments, the integrated circuit and the substrate are disposed between the closed distal end of the flexible needle sheath and the distal end of the rigid shield.
[0011] In some embodiments, the RFID tag includes a bendable elongated inlay formed of a flexible conductive material.
[0012] In some embodiments, the RFID tag is U-shaped and includes an integrated circuit and a pair of legs having two or more antennas.
[0013] In some embodiments, an RFID tag includes an integrated circuit, a substrate, and an antenna formed by a first antenna leg, a second antenna leg, a third antenna leg, and a fourth antenna leg.
[0014] In some embodiments, the flexible needle sheath is formed from an elastomeric material.
[0015] In some embodiments, the tag is at least one of an Ultra High Frequency (UHF) RFID tag, a High Frequency (HF) RFID tag, a High Frequency - Near Field Communication (HF-NFC) RFID tag, a Low Frequency (LF) RFID tag, a Bluetooth tag, an Ultra Wideband Real-Time Location System (RTLS), or a Wi-Fi RTLS.
[0016] In some embodiments, the tag is configured to store a unique device identifier.
[0017] In some embodiments, the unique device identifier includes at least one of a batch number, manufacturing line, test results, timestamp, expiration date, drug identification, process settings, and ingredient batch number for the contents of the syringe to which the rigid needle shield assembly is coupled.
[0018] In some embodiments, during assembly of the rigid needle shield assembly, a flexible needle sheath is used to press the RFID tag into place between the inner sidewall of the rigid shield and the outer sidewall of the flexible needle sheath.
[0019] In some embodiments, the first and second antenna legs are bent by forcing the RFID tag into place between the inner sidewall of the rigid shield and the outer sidewall of the flexible needle sheath.
[0020] In some embodiments, during assembly of the rigid needle shield assembly, the RFID tag is selected from an RFID tag packaging strip that includes a plurality of serially packaged RFID tags.
[0021] Further details and advantages of the present disclosure will be understood from the following detailed description read in conjunction with the accompanying drawings. [Brief description of the drawings]
[0022] [Figure 1] FIG. 1 is an isometric view of a syringe assembly incorporating a rigid needle shield (RNS) assembly according to an aspect of the present disclosure. [Diagram 2] FIG. 1 is a side cross-sectional view of an RNS assembly incorporating an RFID tag according to an embodiment of the present disclosure. [Figure 3A] FIG. 3 is an exploded cross-sectional view of the RNS assembly of FIG. 2 in a first configuration. [Figure 3B] FIG. 3 is an exploded cross-sectional view of the RNS assembly of FIG. 2 in a second configuration. [Figure 4] 1 is a partial top view of an RFID tag packaging assembly according to another aspect of the present disclosure. [Figure 5A] FIG. 2 is an isometric view of an RFID tag according to an embodiment of the present disclosure. [Figure 5B] FIG. 2 is an isometric view of an RFID tag according to another embodiment of the present disclosure. [Figure 5C] FIG. 2 is an isometric view of an RFID tag according to another embodiment of the present disclosure. [Figure 6A] FIG. 2 is a top view of an RFID tag according to another embodiment of the present disclosure. [Figure 6B] FIG. 6B is an isometric view of the RFID tag of FIG. 6A disposed on a flexible needle sheath according to another embodiment of the present disclosure. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0023] The following description is provided to enable a person skilled in the art to make and use the described aspects contemplated for carrying out the invention. However, various modifications, equivalents, variations, and alternatives will still 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.
[0024] For purposes of the following description, the terms "upper", "lower", "right", "left", "vertical", "horizontal", "top", "bottom", "lateral", "longitudinal", and derivatives thereof shall refer to the invention as oriented in the figures. It should be understood, however, that the invention may contemplate various alternative variations unless expressly stated otherwise. It should also be understood that the specific devices illustrated in the accompanying figures and described in the following specification are merely exemplary embodiments of the invention. Hence, specific dimensions and other physical characteristics relating to the embodiments disclosed herein are not to be considered as limiting.
[0025] In this disclosure, the distal end of a component or device means the end that is furthest from the user's hand when the component or device is in the position for use, i.e., when a user is holding the syringe assembly during preparation or use, and the proximal end means the end that is closest to the user's hand. Similarly, in this application, the terms "distal direction" and "distally" refer to the direction of injection, and the terms "proximal direction" and "proximal" refer to the direction opposite to the direction of injection.
[0026] 1, a syringe assembly 20 according to an embodiment of the present disclosure is shown. The syringe assembly 20 includes an elongated syringe barrel 21 having a proximal end 22 and a tip portion (not shown) extending from a distal end 27 of the syringe barrel 21. The tip portion may include a sharpened needle cannula (not shown) extending therefrom, which may be selectively covered by a rigid needle shield (RNS) assembly 40.
[0027] A stopper 34 may be slidably disposed in fluid-tight engagement inside the syringe barrel 21, and the stopper 34 is engaged with the plunger rod 35 to facilitate its movement. The stopper 34 may move fluid through the syringe barrel 21 when the stopper 34 moves toward the distal end 27, and may also draw fluid into the syringe barrel 21 when the stopper 34 moves away from the distal end 27. The plunger rod 35 may be provided with a plunger rod flange 37 to provide structure for applying a force to move the plunger rod 35 (and thus the stopper 34) relative to the syringe barrel 21.
[0028] 2, an RNS assembly 40 according to the present disclosure is shown in more detail. The RNS assembly 40 includes an outer rigid shield 42 and an inner flexible or flexible needle sheath 52 that is fixedly disposed within the rigid shield 42 after assembly. The rigid shield 42 includes an open proximal end 44 and a distal end 46 that is at least partially closed. The rigid shield 42 also includes an outer sidewall 47 and an inner sidewall 48. The rigid shield 42 may be formed of any suitable rigid material, such as a rigid plastic or polymeric material (e.g., polypropylene (PP), polyethylene (PE), polycarbonate (PC), etc.).
[0029] The flexible needle sheath 52 includes an open proximal end 54, a closed distal end 56, an exterior sidewall 57, and an interior sidewall 58. The open proximal end 54, the closed distal end 56, and the interior sidewall 58 define a receptacle 59 sized and configured to receive a needle of a syringe. The flexible needle sheath 52 is sized and configured to be disposed within the rigid shield 42, and in some embodiments may be configured such that the flexible needle sheath 52 cannot be easily removed after production of the RNS assembly 40. The flexible needle sheath 52 may be formed of any suitable resilient material, such as, for example, a thermoplastic elastomer (TPE), a rubber such as bromobutyl rubber, or an elastomeric material.
[0030] 2, the RNS assembly 40 further includes an RFID tag 60. The RFID tag 60 may be provided with unique device identifier (UDI) information, thereby allowing each RNS assembly 40 (and therefore each syringe) to incorporate a unique readable data readout relating to, for example, batch number, manufacturing line, test results, timestamp, expiration date, drug identification, process settings, ingredient batch number, etc. One or more RFID readers may then be available to access the UDI of each RFID tag 60, and software and / or database solutions may be provided to enable storage and access of data linked to the UDI of each RFID tag 60.
[0031] 2, RFID tag 60 is disposed within rigid shield 42, disposed between inner sidewall 48 of rigid shield 42 and outer sidewall 57 of flexible needle sheath 52. In this manner, RFID tag 60 is substantially protected within RNS assembly 40 to avoid damage, wear, tampering, etc., while still providing effective readability by one or more RFID readers.
[0032] In some embodiments, RFID tag 60 may include a surface mounted integrated circuit 62 attached to a substrate 64 (e.g., a printed circuit board (PCB), a paper substrate, a polymer substrate, etc.). Additionally, RFID tag 60 may include a dipole antenna having a first antenna leg 65A and a second antenna leg 65B, one end of each of first antenna leg 65A and second antenna leg 65B coupled to substrate 64 by any suitable connection method, such as, for example, welding.
[0033] 2, the integrated circuit 62 and substrate 64 may be disposed between the distal end 46 of the rigid shield 42 and the distal end 56 of the flexible needle sheath 52, while each first antenna leg 65A and second antenna leg 65B are bent or otherwise folded such that each antenna leg extends along the length of the RNS assembly 40 between the inner sidewall 48 of the rigid shield 42 and the outer sidewall 57 of the flexible needle sheath 52. With such a configuration of the first antenna leg 65A and second antenna leg 65B, the antenna length of the RFID tag 60 may be maximized relative to the size of the RNS assembly 40, thereby improving the read range of the RFID tag 60.
[0034] Although first antenna leg 65A and second antenna leg 65B are shown extending only along a portion of RNS assembly 40, it should be understood that each antenna leg may be longer or shorter than that shown in Figure 2. For example, first antenna leg 65A and second antenna leg 65B may be configured to each extend along substantially the entire length of interior sidewall 48 of rigid shield 42 to maximize the read range of RFID tag 60.
[0035] When RFID tag 60 is assembled within RNS assembly 40 in this manner, RFID tag 60 essentially remains at the distal tip portion of the syringe to which RNS assembly 40 is applied, thereby facilitating reading of RFID tag 60 when the syringe is nested in a tub (with or without multiple additional syringes also having RFID tags).
[0036] Additionally, it should be understood that the RFID tag 60 may be any suitable RFID tag, such as, for example, an ultra-high frequency (UHF) RFID tag, a high frequency (HF) RFID tag, a high frequency-near field communication (HF-NFC) RFID tag, and / or a low frequency (LF) RFID tag. Additionally and / or alternatively, the antenna of the RFID tag 60 may be a dipole as shown in FIG. 2, or may be made with one or more loops, folded, and / or wound to increase radio frequency coupling when the RFID tag 60 is installed in the RNS assembly 40. Furthermore, although an RFID tag 60 is shown and described herein, it should 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, ultra-wideband real-time location systems (RTLS), and / or Wi-Fi RTLS may be utilized instead of (or in addition to) an RFID tag.
[0037] 3A and 3B, a method of assembling the RNS assembly 40 according to aspects of the present disclosure is shown. As described above with respect to FIG. 2, the rigid shield 42, the flexible needle sheath 52, and the RFID tag 60 are each formed as separate elements, with both the flexible needle sheath 52 and the RFID tag 60 disposed within the rigid shield 42. In some embodiments, during production of the RNS assembly 40, the flexible needle sheath 52 may be utilized to press the RFID tag 60 into a desired location within the rigid shield 42. For example, as shown in FIG. 3A, the RFID tag 60 may be provided in a first configuration, with the first and second antenna legs 65A and 65B protruding substantially parallel to a plane formed by the substrate 64. During the manufacturing process, the RFID tag 60 may be introduced between the rigid shield 42 and the flexible needle sheath 52 such that the RFID tag 60 is pressed into the internal cavity 49 at the same time that the flexible needle sheath 52 is pressed into the internal cavity 49 of the rigid shield 42.
[0038] 3B, as substrate 64 of RFID tag 60 is forced further into interior cavity 49 by distal end 56 of flexible needle sheath 52, first antenna leg 65A and second antenna leg 65B may be bent or folded inwardly by contact with interior sidewall 48 of rigid shield 42, ultimately being retained within RNS assembly 40 in the second configuration as shown in FIG. 2. In this manner, the structure of RNS assembly 40 may remain streamlined, even including integrated RFID tag 60 disposed within the gap between rigid shield 42 and flexible needle sheath 52.
[0039] Although not shown in FIGS. 2-3B, it should be understood that in other embodiments, at least a portion of the RFID tag 60 may be affixed or otherwise secured to the rigid shield 42 and / or the flexible needle sheath 52, for example, by an adhesive. The adhesive may be formed of any suitable adhesive, such as, for example, a UV-curable adhesive, a rubber adhesive, a glue, a wet inlay, a silicone adhesive, a resin (e.g., an epoxy), and the like. In some embodiments, the RFID tag 60 may be affixed to the outer sidewall 57 of the flexible needle sheath 52 before the flexible needle sheath 52 is inserted into the interior cavity 49 of the rigid shield 42. In other embodiments, the RFID tag 60 may be affixed to the inner sidewall 48 of the rigid shield 42 before the flexible needle sheath 52 is inserted into the interior cavity 49 of the rigid shield.
[0040] 3A and 3B relate to the manner in which the first and second antenna legs 65A, 65B are bent during assembly of the overall RNS assembly, the RFID tag 60 is not limited to such a configuration, i.e., the RFID tag 60 may be, for example, pressed, folded, stamped, embossed, punched, drawn, bent, or formed by any other suitable method into a suitable shape to fit into the gap between the rigid shield 42 and the elastomeric needle shield 52.
[0041] 4, an RFID tag packaging assembly 70 according to another embodiment of the present disclosure is shown. As noted above, production of an RNS assembly 40 including an RFID tag 60 may be automated, such that the RFID tag 60 is disposed within the rigid shield 42 at the same time that the flexible needle sheath 52 is pressed into the rigid shield 42. To further simplify production of a plurality of RNS assemblies 40, a plurality of RFID tags 60 may be packaged in series with one another to form an RFID tag packaging strip 70, as shown in FIG. 4. In particular, the distal ends of each of the first and second antenna legs 65A, 65B of the plurality of RFID tags 60 may be secured to respective tape portions 72, 74 of the RFID tag packaging strip 70. The RFID tag packaging strip 70 may then be provided in an RNS assembly machine, where each RFID tag 60 may be individually decoupled from the tape portions 72, 74 for disposition within the RNS assembly 40.
[0042] 4 illustrates the RFID tag packaging strip 70 as having two separate tape portions 72, 74 securing the respective ends of the first antenna leg 65A and the second antenna leg 65B of the plurality of RFID tags 60, it should be understood that only a single tape portion may be sufficient. Furthermore, the securing of the plurality of RFID tags 60 is not limited to using tape portions, and any other form of securing the antenna legs, substrates, and / or integrated circuits of the plurality of RFID tags 60 may be utilized.
[0043] 5A-5C, various configurations of RFID tags according to embodiments of the present disclosure are shown. FIG. 5A shows the RFID tag 60 described above with respect to FIGS. 2-4, having a surface mount integrated circuit 62 mounted on a substrate 64 and a dipole antenna having a first antenna leg 65A and a second antenna leg 65B. However, other forms of RFID tags may be utilized according to the present disclosure. For example, with reference to FIG. 5B, an RFID tag 80 is shown, in which the RFID tag 80 is formed as an elongated and / or bendable inlay having flexible conductive materials. Such inlays are readily available, inexpensive, and simple to manufacture. Based on the flexibility of these materials, the RFID tag 60 may be bent or folded into a suitable shape to fit within an RNS assembly. More specifically, the RFID tag 80 may include respective leg portions 84A, 84B forming an antenna, which may be bendable relative to a central circuit portion 82. In another embodiment shown in Figure 5C, RFID tag 90 may be based on a substantially U-shaped tag having a pair of respective leg portions 94A, 94B providing two (or more) antennas and a central integrated circuit portion 82 formed between leg portions 94A, 94B. By having a U-shaped inlay, the assembly process of the inlay may be easier while improving radio frequency performance and thereby increasing read range. With these configurations, RFID tags 80, 90 may also be disposed in an RNS assembly using methods similar to those disclosed above with respect to RFID tag 60.
[0044] 6A and 6B, an RFID tag 100 according to another embodiment of the present disclosure is shown. The RFID tag 100 is similar to the RFID tag 60 described above, but includes two additional antennas, thereby providing improved readability of the RFID tag when housed within an RNS assembly. In particular, the RFID tag 100 is configured to include a surface mount integrated circuit 102 attached to a substrate 104 with an antenna configuration incorporating a first antenna leg 106A, a second antenna leg 106B, a third antenna leg 106C, and a fourth antenna leg 106D. Each of the antenna legs 106A-106D may be coupled to the substrate 104 by any suitable connection method, such as, for example, welding. Additionally, as shown in FIG. 6B, antenna legs 106A-106D may be bendable / foldable around at least a portion of flexible needle sheath 52, thereby allowing RFID tag 100 to be secured within an RNS assembly in a manner similar to RFID tag 60 described above with respect to FIGS. 2-3B.
[0045] Although several embodiments of RNS assemblies incorporating RFID tags are shown in the accompanying figures and described in detail herein above, other embodiments will be apparent to and readily made by those skilled in the art without departing from the spirit and scope of the present invention. For example, it should be understood that the present disclosure contemplates, to the extent possible, that one or more features of any embodiment can be combined with one or more features of any other embodiment. Thus, the foregoing description is intended to be illustrative rather than limiting.
Claims
1. A rigid needle shield assembly (40) for covering a needle of a syringe, comprising: a rigid shield (42) having an open proximal end (44), a distal end (46), an exterior sidewall (47), and an interior sidewall (48); a flexible needle sheath (52) having an open proximal end (54), a closed distal end (56), an exterior sidewall (57), and an interior sidewall (58); An RFID tag (60) having at least a first antenna leg (65A) and a second antenna leg (65B); A rigid needle shield assembly (40) comprising: the flexible needle sheath (52) and the RFID tag (60) are disposed within the rigid shield (42); the RFID tag (60) is disposed between the inner sidewall (48) of the rigid shield (42) and the outer sidewall (57) of the flexible needle sheath (52); The first antenna leg (65A) and the second antenna leg (65B) extend along the length of the rigid shield (42) between the inner sidewall (48) of the rigid shield (42) and the outer sidewall (57) of the flexible needle sheath (52). A rigid needle shield assembly (40).
2. The RFID tag (60) is equipped with a dipole antenna. The rigid needle shield assembly (40) of claim 1.
3. The RFID tag (60) comprises an integrated circuit (62) coupled to a substrate (64).
3. A rigid needle shield assembly (40) according to claim 1 or 2.
4. The first antenna leg (65A) and the second antenna leg (65B) are coupled to the substrate (64) and are bendable relative to the substrate (64). The rigid needle shield assembly (40) of claim 3.
5. The integrated circuit (62) and the substrate (64) are disposed between the closed distal end (56) of the flexible needle sheath (52) and the distal end (46) of the rigid shield (42).
5. A rigid needle shield assembly (40) according to claim 3 or 4.
6. The RFID tag (80) comprises a bendable elongated inlay formed of a flexible conductive material. The rigid needle shield assembly (40) of claim 1.
7. The RFID tag (90) is U-shaped and includes an integrated circuit (92) and a pair of legs (94A, 94B) having two or more antennas. The rigid needle shield assembly (40) of claim 1.
8. The RFID tag (100) comprises an integrated circuit (102), a substrate (104), and an antenna formed by a first antenna leg (106A), a second antenna leg (106B), a third antenna leg (106C), and a fourth antenna leg (106D). The rigid needle shield assembly (40) of claim 1.
9. The flexible needle sheath (52) is formed of an elastomeric material. A rigid needle shield assembly (40) according to any one of the preceding claims.
10. The tag (60, 80, 90, 100) is at least one of an ultra-high frequency (UHF) RFID tag, a high frequency (HF) RFID tag, a high frequency-near field communication (HF-NFC) RFID tag, a low frequency (LF) RFID tag, a Bluetooth tag, an ultra-wideband real-time location system (RTLS), or a Wi-Fi RTLS. A rigid needle shield assembly (40) according to any one of the preceding claims.
11. The tag (60, 80, 90, 100) is configured to store a unique device identifier. A rigid needle shield assembly (40) according to any one of the preceding claims.
12. The unique device identifier includes at least one of a batch number, manufacturing line, test results, timestamp, expiration date, drug identification, process settings, and ingredient batch number for the contents of the syringe to which the rigid needle shield assembly (40) is coupled. The rigid needle shield assembly (40) of claim 11.
13. During assembly of the rigid needle shield assembly (40), the flexible needle sheath (52) is used to press the RFID tag (60) into place between the inner sidewall (48) of the rigid shield (42) and the outer sidewall (57) of the flexible needle sheath (52). A rigid needle shield assembly (40) according to any one of the preceding claims.
14. By forcing the RFID tag (60) into place between the inner sidewall (48) of the rigid shield (42) and the outer sidewall (57) of the flexible needle sheath (52), the first antenna leg (65A) and the second antenna leg (65B) are bent. The rigid needle shield assembly (40) of claim 13.
15. During assembly of the rigid needle shield assembly (40), the RFID tag (60) is selected from an RFID tag packaging strip (70) comprising a plurality of serially packaged RFID tags (60). A rigid needle shield assembly (40) according to any one of the preceding claims.