Radio Frequency Identification (RFID) Embeds for Use with Medical Injection Devices

Abstract

A tip cap assembly for coupling with a syringe body includes a luer lock adapter, a rigid cap coupled to the luer lock adapter, a rigid tip cap having a distal end and proximal ends, the rigid tip cap being disposed at least partially within the rigid cap, an RFID tag positioned over the distal end of the tip cap, and an adhesive layer formed over the RFID tag. An RFID inlay is also provided for use with medical devices, including a mesh substrate, an RFID antenna, and an integrated circuit assembly bonded to the mesh substrate.A syringe and label assembly is disclosed, including a body having distal and proximal ends, a tip cap assembly having a distal end and proximal ends, and a label surrounding at least partially the distal end of the syringe body and the proximal end of the tip cap, the label comprising an integrated RFID tag.

Description

Radio Frequency Identification (RFID) Embeddings for Use with Medical Injection Devices CROSS REFERENCE TO RELATED APPLICATIONS This application claims priority over the United States provisional application serial numbers 63 / 108.497, filed November 2, 2020, entitled Radio Frequency Identification (RFID) Inlays for Use with Injection Medical Devices, and 63 / 124.126, filed December 11, 2020, entitled Radio Frequency Identification (RFID) Inlays for Use with Injection Medical Devices, the full disclosures of each of which are incorporated herein by reference in their entirety. BACKGROUND Field of dissemination This disclosure relates to injection medical devices that use data tags or inlays, such as radio frequency identification (RFID) tags or inlays, including methods of manufacturing such devices. Description of the related technique Medical injection devices, such as pre-filled or pre-charged syringes, typically include a hollow body or cylinder that forms a container for a medical product. This body includes a distal end, which may optionally be fitted with a needle, and a proximal end, usually fitted with a flange. There is an increasing need for individual traceability of medical containers, such as injection medical devices, extending with such traceability from the manufacturing process to final labeling, end use and / or disposal of the medical containers. While it is common to use machine-readable identifiers, such as barcodes, QR codes, and / or RFID tags, to provide traceability for products like injectable medical devices, these identifiers are often accessible from the surface of containers or other devices, making them potentially susceptible to damage or tampering. Furthermore, the placement of many existing identifiers on devices often hinders effective and efficient scanning / reading. BRIEF DESCRIPTION In light of the above, there is a need for traceable identifiers, such as RFID tags or inlays, that are resistant to damage and / or tampering, provide stronger evidence of tampering, and / or offer improved machine readability. There is also a need to track a medical device from the manufacturing stage to its disposal stage. Furthermore, there is a need to provide medical evidence that serves as proof of tampering. The embodiments described herein pertain to a tip-cap assembly for attachment to a medical device such as a vial or syringe, typically a pre-filled syringe. The tip-cap assembly is configured to attach to a syringe body and includes a luer-lock adapter, a rigid cap attached to the luer-lock adapter, and a rigid tip cap having a distal and a proximal end, the rigid tip cap being disposed at least partially within the rigid cap. The tip-cap assembly further includes an RFID tag positioned on the distal end of the rigid tip cap. An adhesive layer may be formed over the RFID tag. The tip-cap assembly can be attached to a syringe via a luer-lock adapter that screws onto a distal end of the syringe body. In some embodiments, the RFID tag is formed as a circular RFID inlay. In some embodiments, the RFID tag extends across the entire distal end of the rigid tip cap. In some embodiments, the RFID tag is 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, or a low-frequency (LF) RFID tag. In some embodiments, the adhesive layer is one of a UV-cured adhesive, a rubber adhesive, a wet inlay, a silicone adhesive, or a resin. Other embodiments of this disclosure relate to an RFID inlay for use with medical devices. The RFID inlay includes a mesh substrate, an RFID antenna, and an integrated circuit chip assembly bonded to the mesh substrate. In some embodiments, the mesh substrate is porous and permeable to gas. In some embodiments, the mesh substrate is made of high-density spun polyethylene fibers. Further embodiments of this disclosure relate to a syringe and label assembly. The syringe and label assembly includes a syringe body having a distal end and a proximal end, as well as a tip cap assembly having a distal end and a proximal end. The syringe and label assembly further includes a label that at least partially surrounds the distal end of the syringe body and the proximal end of the tip cap, wherein the label comprises an integrated RFID tag. In some embodiments, the label is made of a heat-shrinkable tubular material. In some embodiments, the tip cap assembly is a rigid needle protector. In some embodiments, the tip cap assembly comprises a rigid outer protector made of plastic material and a flexible inner protector made of rubber material. In some embodiments, the inner rubber protector is at least partially arranged inside the rigid plastic protector. In some versions, the label also includes a tear-off engraving line. In some embodiments, the tear engraving line passes through a portion of the integrated RFID tag. Additional realizations of this disclosure pertain to a tag for use with syringe and tip cap assemblies. The tag includes a tubular body, an RFID tag attached to or formed as part of the tubular body, and a tear-etched line configured to break the tubular body. In some embodiments, the tubular body is made of a heat-shrinkable material. In some embodiments, the tear-etching line passes through a portion of the RFID tag. Other embodiments of this disclosure relate to a tip cap assembly for attachment to a syringe body, comprising a luer lock adapter, a rigid cap attached to the luer lock adapter, and a rigid tip cap having a distal and a proximal end, the rigid tip cap being disposed at least partially within the rigid cap. The tip cap assembly further includes an RFID tag positioned within the rigid cap and on the distal end of the rigid tip cap. In some embodiments, the RFID tag is formed as a circular RFID inlay. In some embodiments, the RFID tag is held inside the hard cover by an adhesive. In some embodiments, the adhesive is applied to an outer circumferential edge of the RFID inlay. Other embodiments of this disclosure relate to a tip cap assembly for coupling with a syringe body that includes a luer lock adapter, wherein the luer lock adapter comprises at least one annular groove, a rigid cap coupled to the luer lock adapter, and a rigid tip cap, wherein the rigid tip cap is disposed at least partially within the rigid cap. The tip cap assembly further includes an RFID tag positioned within at least one annular groove of the luer lock adapter. In some embodiments, at least one annular groove is located in a distal end portion of the luer lock adapter. In some embodiments, the RFID tag is overmolded into at least one annular slot. In some embodiments, the RFID tag is attached to at least one ring slot. In some embodiments, the RFID tag is ring-shaped. Other embodiments of this disclosure relate to a tip cap assembly for coupling with a syringe body, comprising a luer lock adapter, a rigid cap coupled to the luer lock adapter, and a rigid tip cap, wherein the rigid tip cap is disposed at least partially within the rigid cap. The tip cap assembly further comprises an RFID tag positioned around at least a portion of the luer lock adapter. Other embodiments of this disclosure relate to a tip cap assembly for attachment to a syringe body, comprising a luer lock adapter, a rigid cap attached to the luer lock adapter, and a rigid tip cap, wherein the rigid tip cap is disposed at least partially within the rigid cap. The tip cap assembly further includes an RFID tag positioned around at least a distal portion of the luer lock adapter and a proximal portion of the rigid cap. In some embodiments, the RFID tag also includes a tear-engraving line. In some embodiments, the tear etching line is located at a separation point between the distal portion of the luer lock adapter and the proximal portion of the rigid cap. Other details and advantages of this disclosure will be understood from the following detailed description read together with the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS Figure 1 is a partial cross-sectional side view of a syringe body and tip cap assembly incorporating an RFID inlay according to an aspect of this disclosure; Figure 2 is an isometric view of the syringe body and tip cap assembly incorporating an RFID inlay from Figure 1; Figure 3 is another partial cross-sectional side view of the syringe body and tip cap assembly incorporating an RFID inlay from Figure 1; Figure 4 is a top view of a mesh substrate for a label according to an aspect of this disclosure; Figure 5 is a top view of a mesh substrate for an RFID inlay of IVIA / a / ZUZZ / UI Ο4ΟΊ in accordance with an aspect of this disclosure; Figure 6A is a cross-sectional side view of a syringe body and tip cap assembly incorporating an RFID tag in accordance with an aspect of this disclosure; Figure 6B is a cross-sectional side view of a syringe body and tip cap assembly according to another aspect of this disclosure; Figure 7A is a side isometric view of a tubular label incorporating an RFID tag in accordance with an aspect of this disclosure; Figure 7B is a side view of a syringe body and tip cap assembly incorporating the tubular label of Figure 7A; Figure 7C is a side view of another syringe body and top cap assembly incorporating the tubular label of Figure 7A; Figure 8A is an isometric view of a syringe body and tip cap assembly incorporating an RFID tag in accordance with another aspect of this disclosure; Figure 8B is a cross-sectional side view of the syringe body and tip cap assembly incorporating an RFID tag from Figure 8A; Figure 9A is an isometric view of a syringe body and tip cap assembly incorporating an RFID tag in accordance with another aspect of this disclosure; Figure 9B is a cross-sectional side view of the syringe body and tip cap assembly incorporating an RFID tag from Figure 9A; Figure 10A is an isometric view of a syringe body and tip cap assembly incorporating an RFID tag in accordance with another aspect of this disclosure; and Figure 10B is a cross-sectional side view of the syringe body and tip cap assembly incorporating an RFID tag from Figure 10A. DESCRIPTION OF THE INVENTION The following description is provided to enable those skilled in the art to perform and utilize the described aspects contemplated in carrying out the invention. Various modifications, equivalents, variations, and alternatives, however, will remain readily apparent to those skilled in the art. Each and every one of these modifications, variations, equivalents, and alternatives is intended to fall within the spirit and scope of the present invention. For the purposes of the description below, the terms upper, lower, right, left, vertical, horizontal, top, bottom, side, longitudinal, and their derivatives shall relate to the invention as oriented in the drawings. However, it should be understood that the invention may assume various alternative variations, unless expressly specified otherwise. It should also be understood that the specific devices illustrated in the accompanying drawings and described in the following specification are merely illustrative aspects of the invention. Therefore, the specific dimensions and other physical characteristics related to the aspects disclosed herein should not be considered limiting. With reference to Figures 1-3, several views of a syringe body and tip cap assembly 10 are shown in accordance with one aspect of this disclosure. The syringe body and tip cap assembly 10 includes a syringe body 12 having a tip portion 14, as well as a plastic rigid tip cap (PRTC) assembly 16. The plastic rigid tip cap assembly 16 may consist of several parts, including a luer lock adapter 18, a rigid cap 20, and a rigid tip cap 22 disposed within the rigid cap 20 and configured to at least partially surround the tip portion 14 of the syringe body 12. The luer lock adapter 18 may also be separate from the tip cap assembly 10. Typically, the rigid tip cap 22 is made of rubber or other material known to the trade that permits sterilization gas to pass through the distal end of the rigid tip cap 22.Preferably, the hard cover 20 is made of plastic material. As shown in Figure 2, the luer lock adapter 18 may include a plurality of ribs 19, while the hard cap 20 may also include a plurality of ribs 21. The respective ribs 19, 21 may provide an improved grip with an assembly tool and / or a user's hand when placing and / or removing the hard cap 20, the luer lock adapter 18, or both. Additionally, an RFID tag 24 may be provided at a distal end of the rigid plastic tip cap assembly 16. In some embodiments, the RFID tag 24 is formed as a substantially circular RFID inlay. However, it should be understood that the RFID tag 24 is not limited to a substantially circular inlay shape and may be any suitable RFID tag. The RFID tag 24 may be formed as, for example, an ultra-high frequency (UHF) RFID tag, a high-frequency (HF) RFID tag, a high-frequency near-field communication (HFNFC) RFID tag, and / or a low-frequency (LF) RFID tag. Additionally and / or alternatively, the antenna of the RFID tag 24 may be a dipole or may consist of one or more loops.Furthermore, although the RFID 24 tag is shown and described in this document, it should be understood that other forms of tags and / or readable data inlays may be used and that... IVIA / a / ZUZZ / UI Ο4ΟΊ may be written remotely in accordance with this disclosure. For example, data tags or embeds such as Bluetooth tags, an ultra-wideband real-time location system (RTLS), a WiFi RTLS and / or an infrared RTLS may be used instead of (or in addition to) an RFID tag. As shown in Figures 1-3, the RFID tag 24 can be applied to a circular distal end of the rigid plastic tip cap assembly 16 and secured or held in position at that end by means of an adhesive 26. The adhesive 26 can be formed from any suitable adhesive, such as, for example, a UV-cured adhesive, a rubber adhesive, a glue, a wet inlay, a silicone adhesive, a resin (for example, an epoxy), etc. As shown in Figure 2, the adhesive 26 can be arranged as an annular bead around the outer circumferential edge of the RFID tag 24, thereby adhering the RFID tag 24 at least to the rigid cap 20. In other embodiments, the adhesive 26 can be formed as a layer partially or entirely on the RFID tag 24.In this way, not only does the adhesive 26 retain the RFID tag 24 within the distal end of the rigid plastic tip cap assembly 16, but it also acts to form a protective layer over the RFID tag 24, thereby reducing the likelihood of damage or tampering. In some embodiments, the RFID tag 24 may be sized to extend substantially across the entire surface of the distal end of the rigid plastic tip cap assembly 16, thereby maximizing the antenna length and thus the read range. However, in other embodiments, the RFID tag 24 may be sized to extend only partially across the distal end of the rigid plastic tip cap assembly 16. In some embodiments, the RFID tag 24 may be configured to be positioned on an external, distal surface of the rigid cap 20. Furthermore, the rigid cap 20 may be made of a rubber material. To manufacture the plastic rigid tip cap assembly 16 that has an RFID tag 24, the rigid cap 20 and rigid tip cap 22 can first be supplied and assembled together by, for example, a snap-fit ​​connection. The assembled rigid cap 20 and rigid tip cap 22 can then be attached to the luer lock adapter 18 by, for example, a threaded connection. Attachment to the luer lock can also be made once the luer lock adapter 18 is secured to the distal tip 14 of the syringe by, for example, a snap fit or gluing. The RFID tag 24 can then be placed on the distal end of the rigid tip cap 22, and adhesive 26 can be formed around or on the RFID tag 24 to retain it on the rigid tip cap 22 in relation to the rigid cap 20. In the embodiment shown in Figures 1-3, the RFID tag 24 is held in the XY plane relative to the syringe body 12 and the rigid plastic tip cap assembly 16. With this orientation, the read distance of the RFID tag 24 can be maximized. Additionally, this orientation makes the RFID tag 24 easier to read from the bottom of a medical injection device tube, since multiple medical injection devices are typically held within the tube in a vertical orientation. Another advantage of the configuration shown in Figures 1-3 is that many suppliers use similar rigid plastic tip cap assemblies, allowing for the outsourcing of the device's construction. Furthermore, a circular RFID inlay like the one shown can be less expensive than other RFID technologies (such as, for example, solid RFID tags). Also, because the RFID tag 24 is simply added to the rigid plastic tip cap assembly 16 and secured by, for example, adhesive 26, there is no impact on or required changes to the molding of the rigid plastic tip cap assembly 16 and / or syringe 12 components. The following, with reference to Figures 4 and 5, shows a mesh substrate for use with RFID tags and / or inlays in accordance with other aspects of the disclosure. Most conventional labels used with medical devices, such as injection devices, utilize a solid film made of materials like polyethylene terephthalate (PET), polyimide (PL), or paper. However, these labels are generally non-porous and are applied after the device has been formed, thus limiting their transparency to the gases used for sterilization and / or their adhesion to the device. Furthermore, such solid film labels can trap gases and / or moisture. In contrast, Figure 4 illustrates a label 30 having a mesh substrate 32 according to one aspect of this disclosure. The mesh substrate 32 may be made of a fine mesh material such as, for example, a porous perforated layer of PET, PL, or paper. Examples of such material include, for example, Tyvek® films, Gore-Tex®, bandage material, etc. When using a Label 30 with a 32 mesh substrate, an adhesive such as a UV-cured resin (e.g., polypropylene) can penetrate the 32 mesh substrate during processing, allowing the Label 30 to be attached to various parts of the device during processes such as in-mold labeling, gluing, molding, etc. Furthermore, the 32 mesh substrate allows gases to pass through, enabling processes such as sterilization (EtO, steam, etc.), degassing, desorption, exudation, etc. The 32 mesh substrate also prevents the trapping of gases or moisture within the Label 30. To manufacture label 30, one or more layers of a porous substrate material, such as Tyvek®, may be used, along with an adhesive if more than one layer is required. Alternatively, a solid film material (or layers of solid film material) may initially be used, with small holes or micro-perforations perforating the material spread across the entire surface to form the mesh substrate 32. With reference to Figure 5, an RFID inlay 40 using a similar mesh substrate is shown. Specifically, the RFID inlay 40 includes a mesh substrate 42, along with an RFID antenna 44 and an integrated circuit (IC) chip 46. As with the 32-mesh substrate described above, the 42-mesh substrate can be made of a fine-mesh material such as, for example, a porous perforated layer of PET, PI, or paper. Examples of such material include, for example, Tyvek® films, Gore-Tex®, bandage material, etc. By using the 42-mesh substrate, an adhesive such as a UV-cured resin (e.g., polypropylene) can penetrate the RFID 40 inlay during processing, enabling the RFID 40 inlay to be attached to various parts of the device during processes such as in-mold labeling, gluing, molding, etc. Furthermore, the 42-mesh substrate allows gases to pass through, enabling processes such as sterilization (EtO, steam, etc.), degassing, desorption, and exudation. The 42-mesh substrate also prevents the trapping of gases or moisture within the RFID 40 inlay. To manufacture the RFID inlay 40, one or more layers of a porous substrate material (i.e., a high-density spun polyethylene fiber such as, for example, Tyvek®) can be used, along with an adhesive if more than one layer is present. Additionally, the RFID antenna 44 and IC chip 46 can be printed / assembled and adhered to the mesh substrate 42. Alternatively, a solid film material (or layers of solid film material) can initially be used, with small holes or micro-perforations perforated across the material to form the mesh substrate 42, with the RFID antenna 44 and IC chip 46 then printed / assembled and adhered to the mesh substrate 42. The following, with reference to Figures 6A and 6B, shows syringe and label configurations in accordance with another aspect of this disclosure. Specifically, with reference to Figure 6A, a syringe and label assembly 50 is shown. The syringe and label assembly 50 includes a syringe body 52 having a needle 54 positioned at its distal end, along with a tip cap 56 configured to be removably attachable to the syringe body 52 to selectively cover the needle 54. In the embodiment shown in Figure 6A, the tip cap 56 is formed as a rigid needle shield (RNS) and an inner rubber shield and can thus simply be snapped onto the tip portion of the syringe body 52. ​​The inner rubber shield is at least partially inserted within the rigid needle shield, which can be made of any plastic material known to the person skilled in the art, and then the tip cap assembly is snapped onto the tip portion of the syringe body 52. Additionally, the syringe and label assembly 50 may further include a label 60 having an RFID tag 62 integrated into or embedded therein, for example, as an inlay. In one embodiment, the label 60 is formed from a heat-shrinkable tubular material. The tube-shaped label 60 can therefore be inserted around the syringe body 52 such that the label 60 overlaps a distal portion of the syringe body 52 and a proximal portion of the tip cap 56. Heat (for example, approximately 90°C) can then be applied to the label 60 to shrink it around a connection region between the syringe body 52 and the tip cap 56. Alternatively, in another embodiment, the label 60 may be formed from a conventional label material (e.g., PET, PI, paper, etc.) and placed, via an adhesive, such that the label 60 overlaps with a distal portion of the syringe body 52 and a proximal portion of the tip cap 56. Although not shown in Figure 6A, tag 60 includes breakable bridges that open when tip cap 56 is removed. Consequently, tag 60 not only provides traceability via RFID tag 62, but also gives a visual indication to a user as to whether or not tip cap 56 has been removed from syringe body 52. ​​In this way, tag 60 provides visual evidence of whether the medical device has been tampered with or opened, enabling traceability up the container lever (from syringe manufacturing to syringe use and disposal), and also helps ensure that tip cap 56 is not accidentally removed from syringe body 52. With reference to Figure 6B, a syringe and label assembly 70 is shown. Similar to the syringe and label assembly 50 described above with respect to Figure 6A, the syringe and label assembly 70 uses label 60, although in conjunction with a plastic rigid tip cap (PRTC) assembly 74 attached to a syringe body 72, as opposed to an RNS tip cap. Thus, with the syringe and label assembly 70, label 60 provides the same advantages as those described above (i.e., visual evidence of whether the medical device was tampered with or otherwise opened, allowing traceability up to the container lever (from syringe manufacture to syringe use and disposal), etc.).Likewise, label 60 can also act to prevent unwanted rotation of the luer lock adapter of the plastic rigid tip cap assembly 74, as well as inadvertent removal of the plastic rigid tip cap assembly 74 from the syringe body 72. The following, with reference to Figures 7A-7C, illustrate syringe and tag configurations in accordance with another aspect of this disclosure. Similar to the tag 60 described above, Figure 7A shows a tag 80 having an RFID tag 86 integrated into or on it, for example, as an inlay. In one embodiment, the tag 80 is formed from a heat-shrinkable tubular material. Accordingly, with reference to the syringe and tag assembly 90 shown in Figure 7B, the tag 80, in the form of a tube 82, can be inserted around a syringe body 92 such that the tag 80 overlaps a distal portion of the syringe body 92 and a proximal portion of a plastic rigid tip cap (PRTC) assembly 94 coupled to a syringe body 92.Next, heat (for example, about 90°C) can be applied to label 80 to shrink label 80 around a connection region of the syringe body 92 and the rigid plastic tip cap assembly 94. Figure 7C shows a similar syringe assembly and label 100 configuration, although belonging to a syringe body 102 and a tip cap 104 (i.e., an RNS), wherein the tip cap 104 is configured to be removably attached to the syringe body 102 to selectively cover a needle (not shown). The label 80 can be configured to slide over portions of the syringe body 102 and the tip cap 104 around a connection region thereof. Alternatively, in another embodiment, the label 80 may be formed from a conventional label material (e.g., PET, Pl, paper, etc.), wherein the inner side 84 of the label 80 receives an adhesive (e.g., a rubber adhesive, an acrylic adhesive, etc.) so that the label 80 adheres to and overlaps with a distal portion of the syringe body 92 and a proximal portion of the rigid plastic tip cap assembly 94 (in the case of the syringe and label assembly 90 shown in Figure 7B), or a distal portion of the syringe body 102 and a proximal portion of the tip cap 104 (in the case of the syringe and label assembly 100 shown in Figure 7C). With reference again to Figures 7A-7C, tag 80 also includes a tear-off line 88, which is a perforated line configured to allow easier separation of the rigid plastic tip cap assembly 94 and the tip cap 104 from the syringe body 92 and the syringe body 102, respectively. Also, as shown in Figures 7A-7C, the tear-off line 88 is positioned along tag 80 such that it passes through a portion of the RFID tag 86. In this way, when tag 80 is torn along IVIA / a / ZUZZ / UI 0401 The tear-engraved line 88 not only provides a visual indication that the seal has been broken, but also alters the machine-readable RFID signal provided by RFID tag 86. Thus, tag 80 provides two forms of evidence if the syringe tip cap has been removed (whether through tampering or authorized use). As shown in Figures 7B and 7C, a majority of the RFID tag 86 on label 80 is located on the syringe barrel side of the tear-off etching line 88. Therefore, even if the syringe tip cap is removed, the RFID tag 86 (and its unique identification data) remains attached to the syringe body and is located on the same side as the syringe's medication label. Thus, while tampering or other use of the syringe can be identified by RFID signal changes due to the tag 80 tearing along the tear-off etching line 88, the unique identification data associated with the syringe is not destroyed. With reference to Figures 8A and 8B, a syringe body and tip cap assembly 200 is shown in accordance with another aspect of this disclosure. The syringe body and tip cap assembly 200 includes a syringe body 202 having a tip portion 204, as well as a plastic rigid tip cap (PRTC) assembly 206. The plastic rigid tip cap assembly 206 consists of multiple parts, including a luer lock adapter 208, a rigid cap 210, and a rigid tip cap 212 disposed within the rigid cap 210 and configured to at least partially surround the tip portion 204 of the syringe body 202. As shown in Figure 8A, the luer lock adapter 208 may include a plurality of ribs 209, while the rigid cap 210 may also include a plurality of ribs 211.The respective ribs 209, 211 can provide an improved grip with an assembly tool and / or a user's hand when attaching and / or removing the hard cover 210, the luer lock adapter 208, or both. Additionally, a substantially ring-shaped RFID tag 214 can be provided at or near a parting line between the luer lock adapter 208 and the rigid cap 210. Specifically, as shown in Figure 8B, the RFID tag 214 can be inserted into an annular groove 216 formed at a distal end of the luer lock adapter 208. In this way, the formation of the luer lock adapter 208, whether by molding, for example, is not substantially altered, but a secure, inserted location within the plastic rigid cap assembly 206 is still provided for the RFID tag 214. Furthermore, by placing the RFID tag 214 in the annular groove 216, the respective ribs 209 and 211 remain unobstructed, which is particularly advantageous when using assembly tools to secure the luer lock adapter 208 and / or the rigid cap 211.Although Figures 8A and 8B show the annular groove 216 located at the distal end of the luer lock adapter 208, it should be understood that the annular groove 216 may be located anywhere else along the external surface of the luer lock adapter 208, such as at the proximal end or proximal portion of the luer lock adapter 208. Although not shown in Figures 8A and 8B, in another embodiment, it should be understood that the rigid cap 210 may include a slot to accommodate the RFID tag 214. Similarly, the slot need not be limited to placement on or near the parting line between the luer lock adapter 208 and the rigid cap 210, and may be located anywhere along the plastic rigid tip cap assembly 206. In some embodiments, the RFID tag 214 can be overmolded onto the luer lock adapter 208 at the location of slot 216. However, it should be understood that the RFID tag 214 is not limited to this shape. For example, in some embodiments, the RFID tag 214 can be configured to clip onto the luer lock adapter 208. Likewise, although the RFID tag 214 is shown substantially in the form of a ring, it should be understood that the RFID tag 214 is not limited to this shape and can have any suitable form capable of emitting an RFID signal. The RFID tag 214 can be configured 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 214 can be a dipole, or it can be formed from one or more loops. Furthermore, although the RFID tag 214 is shown and described herein, it should be understood that other forms of tags and / or data inlays that are remotely readable and writable in accordance with this disclosure may be used. For example, data tags or inlays such as Bluetooth tags, an ultra-wideband real-time location system (RTLS), a Wi-Fi RTLS, and / or an infrared RTLS may be used instead of (or in addition to) an RFID tag. The following, with reference to Figures 9A and 9B, shows a syringe body and tip cap assembly 300 in accordance with another aspect of this disclosure. The syringe body and tip cap assembly 300 includes a syringe body 302 having a tip portion 304, as well as a plastic rigid tip cap (PRTC) assembly 306. The plastic rigid tip cap assembly 306 consists of multiple parts, including a luer lock adapter 308, a rigid cap 310, and a rigid tip cap 312 disposed within the rigid cap 310 and configured to at least partially surround the tip portion 304 of the syringe body 302. As shown in Figure 9A, the luer lock adapter 308 may include a plurality of ribs 309, while the rigid cap 310 may also include a plurality of ribs 311. The respective ribs 309, 311 can provide an improved grip with an assembly tool and / or a user's hand when attaching and / or removing the hard cap 310, luer lock adapter 308, or both. As shown in Figure 9B, the luer lock adapter 308 includes a distal portion 316, with ribs 309 that do not extend into the distal portion 316. In some embodiments, the distal portion 316 is inset. Substantially surrounding the distal portion 316 is an RFID tag 314. In this way, the formation of the luer lock adapter 308 by, for example, molding, is not substantially changed, but a secure, inset location for housing the RFID tag 314 is still provided. Furthermore, by placing the RFID tag 314 in the distal portion 316 of the luer lock adapter 308, the respective ribs 309 and 311 remain clear, which is particularly advantageous when using assembly tools to secure the luer lock adapter 308 and / or the hard cap 311. In some embodiments, the RFID tag 314 can be formed as an overmolded inlay to enable in-mold labeling on the distal portion 316 of the luer lock adapter 308. However, it should be understood that the RFID tag 314 is not limited to this. The RFID tag 314 can be formed 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 314 can be a dipole, or it can be formed from one or more loops. Furthermore, although the RFID tag 314 is shown and described herein, it should be understood that other forms of remotely writable and readable data tags and / or inlays may be used in accordance with this disclosure.For example, data tags or inlays such as Bluetooth tags, an ultra-wideband real-time location system (RTLS), can use a WiFi RTLS and / or an infrared RTLS instead of (or in addition to) an RFID tag. With reference now to Figures 10A and 10B, a syringe body and tip cap assembly 400 is shown in accordance with another aspect of this disclosure. Unlike the syringe body and tip cap assembly 300 described above with respect to Figures 9A and 9B, which uses an RFID tag 314 covering only the distal portion 316 of the luer lock adapter 308, the syringe body and tip cap assembly 400 is configured to provide evidence of tampering through relative rotation between the luer lock adapter and the rigid cap portions. Specifically, the syringe body and tip cap assembly 400 includes a syringe body 402 having a tip portion 404, as well as a plastic rigid tip cap (PRTC) assembly 406. The plastic rigid tip cap assembly 406 consists of multiple parts, including a luer lock adapter 408, a rigid cap 410, and a rigid tip cap 412 disposed within the rigid cap 410 and configured to at least partially surround the tip portion 404 of the syringe body 402. As shown in Figure 10A, the luer lock adapter 408 may include a plurality of ribs 409, while the rigid cap 410 may also include a plurality of ribs 411. The respective ribs 409 and 411 can provide improved grip with an assembly tool and / or a user's hand when attaching and / or removing the rigid cap 410 and the adapter. luer lock 408, or both. As shown in Figure 10A and Figure 10B, the syringe body and tip cap assembly 400 further includes an RFID tag 414 substantially surrounding both a distal portion of the luer lock adapter 408 and a proximal portion of the rigid cap 410. In this way, the RFID tag 414 overlaps the separation location of the luer lock adapter 408 and a proximal portion of the rigid cap 410. At or near this separation location, the RFID tag 414 may further include a tear-etched line 416. Thus, if and when the luer lock 408 and / or the rigid cap 410 are rotated relative to each other, the tear-etched line 416 provides at least a visual indication that the seal has been broken, thereby providing effective evidence of tampering.Additionally and / or alternatively, if and when the 416 tear-etched line is broken, the machine-readable RFID signal provided by the 416 RFID tag may also be altered or destroyed, thus providing a machine-readable tamper indication. In this way, in some embodiments, the 416 RFID tag can provide two forms of evidence if the components of the 406 plastic rigid tip cap assembly (PRTC) have been separated (either by tampering or authorized use). As shown in Figure 10B, the RFID tag 414 can substantially surround both the distal portion of the luer lock adapter 408 and the proximal portion of the rigid cap 410 in a manner that does not require alteration of the luer lock adapter 408 and / or the rigid cap 410 to accommodate the RFID tag 414. However, although not shown, it should be understood that one or both of the luer lock adapter 408 and the rigid cap 410 can be modified to improve the connection between the RFID tag 414 and the plastic rigid tip cap (PRTC) assembly 406. Furthermore, by placing the RFID tag 414 on the distal portion of the luer lock adapter 408 and on the proximal portion of the rigid cap 410, at least a portion of the respective nerves 409, 411 remains clear, which is particularly advantageous when using assembly tools to secure the luer lock adapter 408 and / or the rigid cap 411. In some embodiments, the RFID tag 414 can be formed as a wet inlay to allow it to extend over portions of both the luer lock adapter 408 and the hard cap 411. However, it should be understood that the RFID tag 414 is not limited to this. The RFID tag 414 can be formed 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 414 can be a dipole, or it can be formed from one or more loops. Furthermore, although the RFID tag 414 is shown and described herein, it should be understood that other forms of remotely writable and readable data tags and / or inlays may be used in accordance with this disclosure.For example, data tags or inlays such as Bluetooth tags, an ultra-wideband real-time location system (RTLS), can use a WiFi RTLS and / or an infrared RTLS instead of (or in addition to) an RFID tag. Although the accompanying figures show various embodiments of different syringe and label assemblies incorporating RFID tags and are described in detail above, other embodiments will be obvious to, and readily made by, those skilled in the art without departing from the scope and spirit of the invention. For example, it should be understood that this disclosure contemplates, to the extent possible, that one or more features of any embodiment may be combined with one or more features of any other embodiment. Accordingly, the foregoing description is intended to be illustrative rather than restrictive.

Claims

1. A tip cap assembly for coupling with a syringe body, comprising: a luer lock adapter; a rigid cap coupled to the luer lock adapter; a rigid tip cap having a distal end and a proximal end, the rigid tip cap being disposed at least partially within the rigid cap; an RFID tag positioned over the distal end of the rigid tip cap; and an adhesive layer formed over the RFID tag.

2. The tip cap assembly of claim 1, wherein the RFID tag is formed as a circular RFID inlay.

3. The tip cap assembly of claim 2, wherein the RFID tag extends over the entire distal end of the rigid tip cap.

4. The tip cap assembly of claim 1, wherein the RFID tag is 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, or a low-frequency (LF) RFID tag.

5. The tip cap assembly of claim 1, wherein the adhesive layer is one of a UV-cured adhesive, a rubber adhesive, a wet inlay, a silicone adhesive, or a resin.

6. An RFID inlay for use with medical devices, comprising: a mesh substrate; and an RFID antenna and an integrated circuit chip set bonded to the mesh substrate.

7. The RFID inlay of claim 6, wherein the mesh substrate is porous and permeable to gases.

8. The RFID inlay of claim 6, wherein the mesh substrate is formed from high-density spun polyethylene fibers.

9. A syringe and tag assembly, comprising: a syringe body having a distal end and a proximal end; a tip cap assembly having a distal end and a proximal end; and a tag at least partially surrounding the distal end of the syringe body and the proximal end of the tip cap assembly, wherein the tag comprises an integrated RFID tag. MOI 10. The syringe and label assembly of claim 9, wherein the label is formed from a heat-shrinkable tubular material.

11. The syringe and label assembly of claim 9, wherein the tip cap assembly is a needle guard assembly comprising a flexible inner guard and a rigid outer guard.

12. The syringe and label assembly of claim 11, wherein the rigid outer protector is a rigid plastic protector, and the flexible inner protector is made of a rubber material.

13. The syringe and label assembly of claim 9, wherein the label further comprises a tear-engraved line.

14. The syringe and label assembly of claim 13, wherein the tear-engraving line passes through a portion of the integrated RFID label.

15. A label for use with syringe and tip cap assemblies, the label comprising: a tubular body; an RFID tag attached to or formed as part of the tubular body; and a tear-etched line configured to break the tubular body.

16. The label of claim 15, wherein the tubular body is formed from a heat-shrinkable material.

17. The label of claim 15, wherein the tear engraving line passes through a portion of the RFID label.

18. A tip cap assembly for coupling with a syringe body, comprising: a luer lock adapter; a rigid cap coupled to the luer lock adapter; a rigid tip cap having a distal end and a proximal end, the rigid tip cap being disposed at least partially within the rigid cap; and an RFID tag positioned within the rigid cap and over the distal end of the rigid tip cap.

19. The tip cap assembly of claim 18, wherein the RFID tag is formed as a circular RFID inlay.

20. The tip cap assembly of claim 18, wherein the RFID tag is retained within the rigid cap by means of an adhesive.

21. The tip cap assembly of claim 20, wherein the adhesive is applied to an outer circumferential edge of the RFID inlay.

22. The tip cap assembly of claim 18, wherein the RFID tag is 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, or a low-frequency (LF) RFID tag.

23. A tip cap assembly for coupling with a syringe body, comprising: a luer lock adapter, wherein the luer lock adapter comprises at least one annular groove; a rigid cap coupled to the luer lock adapter; a rigid tip cap, wherein the rigid tip cap is disposed at least partially within the rigid cap; and an RFID tag positioned within at least one annular groove of the luer lock adapter.

24. The tip cap assembly of claim 23, wherein the at least one annular groove is located in a distal end portion of the luer lock adapter.

25. The tip cap assembly of claim 23, wherein the RFID tag is overmolded into at least one annular groove.

26. The tip cap assembly of claim 23, wherein the RFID tag is engaged in the at least one annular slot.

27. The tip cap assembly of claim 23, wherein the RFID tag is ring-shaped.

28. A tip cap assembly for coupling with a syringe body, comprising: a luer lock adapter; a rigid cap coupled to the luer lock adapter; a rigid tip cap, wherein the rigid tip cap is disposed at least partially within the rigid cap; and an RFID tag positioned around at least a portion of the luer lock adapter.

29. A tip cap assembly for coupling with a syringe body, comprising: a luer lock adapter; a rigid cap coupled to the luer lock adapter; a rigid tip cap, wherein the rigid tip cap is disposed at least partially within the rigid cap; and an RFID tag positioned around at least a distal portion of the luer lock adapter and a proximal portion of the rigid cap.

30. The tip cap assembly of claim 29, wherein the RFID tag further comprises a tear-etched line.

31. The tip cap assembly of claim 30, wherein the tear-etched line is located at a parting point between the distal portion of the luer lock adapter and the proximal portion of the rigid cap.

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