Co-molded rigid cap with integrated rfid and cap end torque transfer features

Abstract

A rigid cap is provided that includes an in-mold portion having a proximal end and a distal end, where the proximal end has an open end and includes a female connector formed on the proximal end, the distal end having a closed end. The rigid cap further includes an RFID element positioned on the inner molded portion at the distal end so as to extend around at least a portion of the distal end; and an outer molded portion formed on the RFID element at the inner molded portion and the distal end so as to enclose the RFID element between the inner molded portion and the outer molded portion, where the outer molded portion has a proximal end and a distal end. The inner molded portion and / or the outer molded portion includes a plurality of circumferentially spaced teeth extending axially from a distal end of the inner molded portion and / or a distal end of the outer molded portion.

Description

Cross-references to related applications

[0001] This application claims priority to European Application No. 23305855.1, filed on May 30, 2023, entitled “Co-Molded Rigid Cap with Integrated RFID and Cap End Torque Transmission Feature,” the entire disclosure of which is incorporated herein by reference.

[0002] Background of the Invention Field of the Invention This disclosure generally relates to rigid caps, such as rigid caps for syringes, and more specifically, to rigid caps having integrated RFID tags and torque transmission features formed thereon.

[0003] Description of related technologies Syringes are used in various settings to administer fluids (e.g., agents or medications) to patients. Many syringes are designed as pre-filled syringes, which offer the convenience of rapidly delivering the fluid to a patient without first drawing the agent from another container and measuring its volume. For dispensing fluid, a pre-filled syringe typically includes a syringe barrel and a plunger assembly. The syringe barrel has an opening at its distal end for fluid communication with the patient (e.g., a Luer-type fitting (needle-free access device) mounted at the distal end of the syringe barrel and connected to the patient's fluid line), and the plunger assembly is inserted through the opposite proximal end of the barrel. The plunger assembly typically includes an elongated plunger rod extending from the barrel and a plunger head or stop at the distal end of the plunger rod. The stop or plunger stop is typically made of a resilient material and includes a body having a tail at the proximal end of the body for attachment to the distal end of the plunger rod and a head at the distal end of the body. Multiple annular outward-protruding ribs are defined on the cylindrical outer wall of the body. When the stop is inserted into the syringe, these ribs are adapted to ensure the integrity of the syringe container closure.

[0004] When using pre-filled syringes, it is desirable to label the syringes to include data about the syringe and / or the contents contained within it (i.e., the medication), and in some embodiments, to enable syringe tracking. That is, it is desirable to have the ability to track the history of a single syringe or a batch of syringes from early in their manufacturing life to the final use of the device. Syringe identification and / or tracking can be provided using electronic components containing data thereon that can be routinely read in and out in a non-contact manner. As an example, electronic components (e.g., RFID tags) can be incorporated into the syringe to provide syringe identification and tracking. In some known syringes, an RFID tag is incorporated into a rigid cap positioned on an opening at the distal end of the syringe barrel, for example, a cap that mates with a Luer-type fitting at the distal end of the syringe barrel. The RFID tag can be embedded within the rigid cap to provide protection for the RFID tag, wherein this embedding of the cap is achieved through a co-molding process used to form the rigid cap.

[0005] While integrating RFID tags into rigid caps to provide syringe identification and / or tracking is known, existing rigid caps with integrated RFID tags may suffer from problems associated with the rigid cap's functionality. As an example, it is known that syringes are typically packaged, stored, and transported in batches within storage containers known as "nests," and the size / diameter of the rigid cap may need to be controlled to allow for automated, machine-automated placement and / or removal of syringes from the nest without interference. However, integrating RFID tags into the rigid cap via a co-molding process may present challenges in achieving the cap's desired functionality while controlling its diameter. Specifically, it is desirable to include splines ("spline teeth") on the outer surface of the rigid cap, extending radially outward, through which the cap can be gripped and twisted via an associated twisting tool to secure it to the syringe; however, including an RFID tag may reduce the available space for forming such spline teeth on the rigid cap. Therefore, the radial height of the spline teeth is reduced in order to keep the rigid cap below the required dimensional limits, and this reduction in spline height and the amount by which it protrudes radially outward from the outer surface of the adjacent cap may negatively affect the external torque transmission from the torsion tool to the cap when the rigid cap is attached to the syringe.

[0006] Therefore, there is a need in the art for a rigid cap that incorporates an RFID tag, but which includes features that provide effective external torque transmission. Summary of the Invention

[0007] This document provides a rigid cap for use with a syringe. The rigid cap includes: a cap housing having a proximal end and a distal end and defining an internal cavity; and an RFID element integrated with the cap housing at the distal end. The cap housing includes a plurality of circumferentially spaced teeth extending axially from the distal end of the cap housing.

[0008] In some configurations, the cap housing includes a first molded portion in which the RFID element is integrated on the inner surface of the first molded portion.

[0009] In some configurations, the RFID element is a hard tag, which includes an RFID chip and an antenna encapsulated in a rigid sleeve, gasket, or disc.

[0010] In some configurations, the cap housing includes a first molded portion in which the RFID element is integrated on the outer surface of the first molded portion.

[0011] In some configurations, the RFID element includes an overmolded tag with in-mold electronics.

[0012] In some configurations, the cap housing includes a first molded portion and a second molded portion, the second molded portion being integrated onto the first molded portion and the RFID element at the distal end, so as to enclose the RFID element between the first molded portion and the second molded portion.

[0013] In some configurations, the RFID element includes a flat RFID inlay that conforms to the cylindrical outer surface of the first molded portion.

[0014] In some configurations, the RFID inlay includes a first edge and an opposing second edge, wherein the RFID inlay extends partially around the distal end of the first molded portion such that a gap exists between the first edge and the second edge, and wherein the second molded portion is in direct contact with the first molded portion at the location of the gap.

[0015] In some configurations, the plurality of circumferentially spaced teeth are provided on each of the first molded portion and the second outer portion.

[0016] In some configurations, a plurality of teeth on the first molded portion are circumferentially aligned with and engaged with a plurality of teeth on the second molded portion.

[0017] In some configurations, the first radial thickness of the distal end of the first molded portion is between 0.2 mm and 1.0 mm, preferably between 0.5 mm and 0.8 mm, and the second radial thickness of the second molded portion is between 0.2 mm and 1.0 mm, preferably between 0.5 mm and 0.8 mm.

[0018] In some configurations, the height of each of the multiple teeth is between 0.5 mm and 3.0 mm.

[0019] In some configurations, each of the multiple teeth includes a rectangular tooth, a triangular tooth, a curved tooth, or a wavy tooth with a flat distal end.

[0020] In some configurations, the plurality of teeth includes two to sixteen teeth, preferably four to eight teeth.

[0021] This document also provides a syringe comprising: a syringe barrel including a proximal end and a distal end and defining a chamber, wherein the syringe barrel has an opening at the proximal end. The syringe further comprises a plunger assembly inserted through the opening and axially movable within the chamber of the syringe barrel, wherein the plunger assembly includes: a plunger rod including an elongated body and extending between the proximal and distal ends; and a stop attached to the distal end of the plunger rod and positioned within the chamber of the syringe barrel. The syringe further comprises a rigid cap having: a cap housing having a proximal end and a distal end and defining an internal cavity; and an RFID element integrated with the cap housing at the distal end. The cap housing includes a plurality of circumferentially spaced teeth extending axially from the distal end of the cap housing. The rigid cap is coupled to an adapter at the distal end of the syringe barrel. Attached Figure Description

[0022] Figure 1 This is a perspective view of a syringe, which is used to implement various embodiments of the present disclosure; Figure 2 for Figure 1 An exploded view of the syringe; Figure 3 To include, according to the non-limiting embodiments described herein, Figure 1 A three-dimensional view of the rigid cap in a syringe; Figure 4 for Figure 3 A side cross-sectional view of a rigid cap, shown as a male connector attached to a syringe; Figure 5 for Figure 3 A perspective view of the inner molded portion of a rigid cap, wherein an RFID tag is positioned on the inner molded portion; Figure 6 To include, according to another non-limiting embodiment described herein, Figure 1 A three-dimensional view of the rigid cap in a syringe; Figure 7 for Figure 6A perspective view of the inner molded portion of a rigid cap, wherein an RFID tag is positioned on the inner molded portion; Figure 8 To include, according to another non-limiting embodiment described herein, Figure 1 A three-dimensional view of the rigid cap in a syringe; Figure 9 for Figure 8 A perspective view of the inner molded portion of a rigid cap, wherein an RFID tag is positioned on the inner molded portion; Figure 10 To include, according to another non-limiting embodiment described herein, Figure 1 A three-dimensional view of the rigid cap in a syringe; Figure 11 for Figure 10 A perspective view of the inner molded portion of a rigid cap, wherein an RFID tag is positioned on the inner molded portion; Figure 12 To include, according to another non-limiting embodiment described herein, Figure 1 An exploded perspective view of the rigid cap in a syringe; Figure 13 To include, according to another non-limiting embodiment described herein, Figure 1 A side cross-sectional view of the rigid cap in the syringe; Figure 14 To include, according to another non-limiting embodiment described herein, Figure 1 A side cross-sectional view of the rigid cap in the syringe; and Figure 15 To include, according to another non-limiting embodiment described herein, Figure 1 A three-dimensional view of the rigid cap in a syringe. Detailed Implementation

[0023] The following description is provided to enable those skilled in the art to make and use the described embodiments intended for carrying out the invention. However, various modifications, equivalents, variations, and substitutions will still be apparent to those skilled in the art. Any and all such modifications, variations, equivalents, and substitutions are intended to fall within the spirit and scope of the invention.

[0024] In the following text, for descriptive purposes, the terms “upper,” “lower,” “right,” “left,” “vertical,” “horizontal,” “top,” “bottom,” “lateral,” “longitudinal,” and their derivatives shall be used in connection with the invention as oriented as shown in the accompanying drawings. However, it should be understood that the invention may take various alternative variations unless explicitly stated to the contrary. It should also be understood that the specific devices shown in the drawings and described in the following specification are merely exemplary embodiments of the invention. Therefore, the specific dimensions and other physical characteristics associated with the embodiments disclosed herein should not be considered limiting.

[0025] In this disclosure, the distal end of a component or device refers to the end furthest from the user's hand when the component or device is in the use position, i.e., when the user holds the syringe in preparation for or during use. The proximal end of a component or device refers to the end closest to the user's hand when the component or device is in the use position, i.e., when the user holds the syringe in preparation for or during use. Similarly, in this application, the terms "in the distal direction" and "towards the distal end" refer to the direction toward the distal tip of the syringe, while the terms "in the proximal direction" and "towards the proximal end" refer to the direction opposite to the direction of the distal tip of the syringe.

[0026] Various aspects and embodiments of this disclosure relate to a rigid cap having an integrated RFID tag and torque transmission features formed thereon. The rigid cap is formed as a co-molded cap, with the RFID tag embedded within the cap and between different molded portions or layers of the cap. The rigid cap includes a front end feature or distal end feature formed thereon that allows external torque applied to the cap (e.g., by a process twisting or tightening tool that engages with the cap) to be transmitted through the cap to torsionally engage the cap with an associated connector on a syringe barrel.

[0027] refer to Figure 1 and Figure 2 The illustration shows a non-limiting embodiment of syringe 10, such as a pre-filled syringe, which can be used to implement aspects or embodiments of the present disclosure. Syringe 10 typically includes a syringe barrel 12 and a plunger assembly 14. For example, plunger assembly 14 may be axially movable within syringe barrel 12 to a forward position to facilitate the administration of injectable fluid (e.g., a pharmaceutical agent) to a patient.

[0028] The syringe barrel 12 is formed by a generally cylindrical outer wall 16 and an end wall 18, which define a chamber 20 for retaining fluid therein. The syringe barrel 12 includes an open proximal end 22 and a distal end 24, the open proximal end 22 being configured to receive a plunger assembly 14 therein, and the end wall 18 being positioned at the distal end 24. The proximal end 22 of the syringe barrel 12 may include a flange 26 to facilitate manipulation and positioning of the syringe 10 and to maintain the relative position of the syringe barrel 12 with respect to the plunger assembly 14 during drug administration. At the distal end 24, a tip 28 extends distally and laterally from the end wall 18 and defines an inner cavity 30 in fluid communication with the chamber 20. A Luer lock adapter 29 is mounted on the outer surface of the tip 28, which is connectable to a rigid cap 60 covering the tip 28 and / or to a corresponding needle hub (not shown), to which the syringe 10 engages for drug administration to the patient. The adapter 29 includes a cylindrical body having a threaded inner surface 33 configured to engage the outer surface of the threaded portion of the rigid cap 60, as explained in further detail below. While a particular adapter 29 is shown and described herein, it should be appreciated that adapters of various constructions known in the art can be provided on the syringe 10 for connecting the syringe 10 to a corresponding needle hub to expel injectable material to a target location.

[0029] The plunger assembly 14 of the syringe 10 comprises an elongated plunger rod 32 (more generally referred to below as "plunger 32") and a plunger head or stop 34. The plunger 32 may include a body 36 extending between a proximal plunger end 38 and a distal plunger end 40. In some embodiments, the body 36 may include a plurality of elongated blades or walls 42 extending along the length axis of the body between the proximal plunger end 38 and the distal plunger end 40. A thumb press 44 is positioned at the proximal plunger end 38, which can be engaged by a user's thumb (or other finger) to apply a distal force to the plunger assembly 14, thereby moving the plunger 32 relative to the syringe barrel 12. In some embodiments, a flanged extension 46 (e.g., a disc flange) is positioned at the distal plunger end 40, the flanged extension being configured to engage with the stop 34.

[0030] A stop 34 of the plunger assembly 14 is positioned at the distal end 40 of the plunger to allow movement with the plunger 32 within the chamber 20 of the syringe barrel 12. The stop 34 may be made of a material different from that of the plunger 32 and capable of forming a tight seal with the syringe barrel 12 as the stop advances through it. In some embodiments, the stop 34 includes a receiving portion (not shown) formed therein, which is sized and configured to receive a flanged extension 46 of the plunger 32, wherein the flanged extension 46 is engaged with the receiving portion, for example, by a press-fit connection, to secure the stop 34 to the plunger 32. However, it is understood that the attachment member 48 and the distal end 40 of the plunger can be secured by other techniques known in the art. The attachment member 48 may also include a pair of spaced-apart annular flanges 58 (i.e., O-rings) formed thereon, which form a tight seal with the cylindrical outer wall 16 of the syringe barrel 12.

[0031] like Figure 1 and Figure 2 As shown, the syringe 10 also includes a rigid cap 60, which can be coupled to the adapter 29 of the syringe barrel 12 to protect the tip 28 from contamination and / or maintain the chamber 20 in a sealed condition or state before use of the syringe 10. The rigid cap 60 can be configured as a rigid cap that mates with the adapter 29 to provide a leak-proof seal on the tip 28, wherein the proximal end 61 of the rigid cap 60 is configured to engage the adapter 29, while the distal end 63 (i.e., the “front end”) is configured to be closed with a resilient inner cap 65 (“RiTC”) to form a closed rigid cap 60 covering the tip 28.

[0032] Based on various aspects and embodiments of this disclosure, and as follows, based on various aspects of this disclosure... Figures 3 to 15 As further shown and described, the rigid cap 60 includes an RFID element or tag 62 integrated therein that allows for the identification and / or tracking of the syringe 10. That is, the RFID element 62 may include or store information thereon about the contents of the syringe 10 (i.e., the agent or drug included in the syringe, if it is a pre-filled syringe) and the manufacturing history of the syringe, and / or may provide location information to an associated reader to enable tracking of the syringe 10. According to embodiments, the RFID element 62 may be disposed on an inner or outer surface of a portion of the rigid cap 60, or may be embedded within the rigid cap 60, as will be explained in further detail below.

[0033] According to embodiments, the RFID element 62 can be provided in any of a variety of forms that allow it to be integrated with the rigid cap 60. In some embodiments, the RFID element 62 can be an inlay including a chip or integrated circuit (IC), an antenna, and a substrate (i.e., a membrane surface) (see [link]). Figures 3 to 11 In other embodiments, the RFID element 62 may be a hard tag comprising a chip and an antenna encapsulated in a rigid sleeve, gasket, or disc (see [link to relevant documentation]). Figures 12 to 14 In other embodiments, the RFID element 62 may be a printed tag comprising an antenna directly printed on a 3D component having a bonding chip, or the RFID element 62 may be an overmolded tag with in-mold electronics (see [link to documentation]). Figure 15 ).

[0034] According to the embodiments, it should be understood that the RFID element 62 can be any type of tag available to a technician. That is, those skilled in the art will clearly understand that other tags besides RFID can also be used. For example, the tag can be a Low Frequency Radio Frequency Identification (LF-RFID) tag (i.e., a frequency from 30 kHz to 300 kHz). The RFID tag can also be a High Frequency Radio Frequency Identification (HF-RFID) tag (i.e., a frequency from 1 MHz to 15 MHz), an Ultra High Frequency Radio Frequency Identification (UHF-RFID) tag (i.e., a frequency from 400 MHz to 1000 MHz), or a dual-frequency tag that includes both HF-NFC and UHF RFID. Alternatively, the RFID tag can be a High-Frequency Near Field Communication (HF-NFC) tag (i.e., a frequency from 1 MHz to 15 MHz).

[0035] According to one aspect or embodiment of this disclosure Figures 3 to 5The rigid cap 60 is shown in further detail. The rigid cap 60 is formed as a rigid cap by a molding process (e.g., injection molding). When the rigid cap 60 includes a first molding portion 64 (“inner molding portion”) and a second molding portion 66 (“outer molding portion”), the rigid cap 60 is formed as a co-molded cap, which is formed by two separate molding processes, wherein the inner molding portion 64 is formed during a first molding shot or process, and the outer molding portion 66 is formed during a second molding shot or process. Thus, each of the inner molding portion 64 and the outer molding portion 66 is formed of a molding-suitable material (e.g., polypropylene, polyethylene, polyvinyl chloride, polystyrene, polycarbonate, acrylonitrile-butadiene-styrene copolymer, styrene-acrylonitrile copolymer, or similar polymers, or combinations thereof). The inner molding portion 64 and the outer molding portion 66 may together define a cap shell 67 of the rigid cap 60. As further explained below, when manufacturing the rigid cap 60, the second molding portion 66 may be formed on a portion of the inner molding portion 64, and the RFID element 62 is integrated between the inner molding portion 64 and the outer molding portion 66.

[0036] like Figure 4 and Figure 5 As best shown, the inner molded portion 64 of the rigid cap 60 can generally be defined to include a proximal end 68 and a distal end 70. The proximal end 68 is configured as an open end and includes a connecting portion 72 formed thereon, which is adapted to be coupled to the adapter 29 or the syringe 10. As previously described, in some embodiments, the distal end 24 of the syringe barrel 12 includes an end 28 thereon on which the adapter 29 is secured / mounted, and in these embodiments, the connecting portion 72 is configured to mate with the adapter 29. The connecting portion 72 may include a cylindrical portion 76 having a threaded outer surface 78 configured to engage the threaded inner surface 33 of the adapter 29, wherein the cylindrical portion 76 defines an opening 82 into which a portion of the resilient inner cap 65 can be inserted.

[0037] In some embodiments, an annular flange 84 may be formed on the inner molded portion 64 adjacent to the cylindrical portion 76 of the connecting portion 72. The annular flange 84 is positioned distal to the proximal end 68 of the inner molded portion 64 (and between the proximal end 68 and the distal end 70) such that when the threaded outer surface 78 of the connecting portion 72 engages with the threaded inner surface 33 of the adapter 29, the annular flange 84 will abut the distal end of the adapter 29, thereby providing a sealing engagement between the rigid cap 60 and the syringe barrel 12.

[0038] The distal end 70 of the inner molding portion 64 is configured as an open end, which is configured to receive an elastic inner cap 65 therein, the elastic inner cap sealing the distal end 70 of the rigid cap 60. That is, the inner molding portion 64 may be formed to include a cylindrical wall 90 that defines a circular opening 86 at the distal end 70 of the inner molding portion, wherein the inner cap 65 is fitted into the opening 86 and extends into a cavity 87 defined by the inner molding portion 64.

[0039] The inner cap 65 may be made of a rubber material (such as a styrene-butadiene rubber or isoprene-bromobutyl rubber blend, or a thermoplastic elastomer). The (rubber) formulation of the inner cap 65 is selected to be inert to the medical solution to be filled into the syringe 10, to have sufficient heat resistance to withstand the necessary sterilization process, and to have suitable gripping and release properties to slide the inner cap 65 onto the tip 28 of the syringe 10 and to release the inner cap after use. The inner cap 65 may be manufactured by molding processes such as injection molding.

[0040] The inner cap 65 includes a proximal skirt 88 and a distal sealing base 89. The proximal skirt 88 has a hollow cylindrical shape, which may be slightly tapered to mate with the tapered shape of the tip 28 of the syringe 10. The distal sealing base 89 may have a central protrusion or connector 91 surrounded by the skirt 88, thereby forming an internal cavity with a generally circular shape suitable for engaging the tip 28 of the syringe 10. The central protrusion 91 extends proximally from the distal sealing base 89 and is centered relative to the distal sealing base. The central protrusion 91 may extend slightly into the distal end of the tip 28 of the syringe 10 (i.e., into the inner cavity 30). The inner diameter of the skirt 88 is selected such that the skirt stretches slightly radially when mounted on the tip 28 of the syringe 10. In other words, the inner diameter of the skirt 88 is slightly smaller than the outer diameter of the tip 28 of the syringe 10. In this way, the inner wall of the skirt 88 tightly surrounds the outer surface of the tip 28 of the syringe 10. The tight geometry and elastomeric material enable the inner cap 65 to provide a liquid-tight seal for the tip 28 of the syringe 10, thereby preventing any leakage and / or contamination of the medical solution.

[0041] exist Figures 3 to 5In the embodiment of the rigid cap 60 shown, the RFID element 62 of the rigid cap 60 is applied to or disposed on the outer surface 92 of the sidewall 90 at the distal end 70 of the inner molded portion 64. According to an embodiment, the RFID element 62 conforms to the cylindrical outer surface 92 of the sidewall 90 and may at least substantially surround the cylindrical outer surface. In some embodiments, the RFID element 62 is configured to surround a large portion of the sidewall 90, but not completely surround it, such that a gap 94 exists between a first edge 95a and an opposing second edge 95b of the RFID element 62. According to an embodiment, the RFID element 62 may be glued to the cylindrical outer surface 92 of the sidewall 90, or bonded to the outer surface 92 by adhesion to molten plastic, to help hold the RFID element 62 in place.

[0042] like Figure 3 and Figure 4 As shown, after molding the inner molding portion 64 and applying the RFID element 62 to the distal end 70 of the inner molding portion 64, an outer molding portion 66 can be formed (i.e., molded) on the inner molding portion 64 and the RFID element 62 to complete the manufacture of the rigid cap 60. The outer molding portion 66 is formed on the inner molding portion 64 and on the RFID element 62 at the distal end 70 of the inner molding portion 64 to enclose the RFID element 62 between the inner molding portion 64 and the outer molding portion 66. The outer molding portion 66 is formed as a generally tubular member surrounding the distal end 70 of the inner molding portion 64, wherein the outer molding portion 66 has a generally cylindrical outer surface 96 thereon. The outer molding portion 66 includes a proximal end 98 and a distal end 100, wherein in some embodiments, the proximal end 98 is positioned adjacent to an annular flange 84, and the distal end 100 is adjacent to and / or generally aligned with the distal end 70 of the inner molding portion 64. According to embodiments, the outer molded portion 66 and the inner molded portion 64 may each have a radial thickness between 0.2 mm and 1.0 mm, and preferably between 0.5 mm and 0.8 mm. In some embodiments, the outer molded portion 66 is formed to have a radial thickness greater than the radial thickness of the distal end 70 of the inner molded portion 64. Furthermore, in embodiments where the RFID element 62 only partially surrounds the sidewall 90, the outer molded portion 66 will directly contact the inner molded portion 64 at the location of the gap 94, thereby forming a bond between the inner molded portion 64 and the outer molded portion 66.

[0043] Based on all aspects of this disclosure, it should be recognized that the outer diameter (outer diameter OD) of the rigid cap 60 SCThis can be limited by the packaging requirements of the syringe 10. That is, it is known that batches of syringes 10 are typically packaged, filled, stored, and / or transported in nests having multiple cavities formed therein to accommodate the syringes. Removal of the syringe 10 from the nest is achieved by sliding the syringe 10 relative to the nest's axial direction, and if the rigid cap 60 exceeds a predetermined diameter, the syringe 10 may become stuck within the cavity during removal from the nest. Therefore, it may be necessary to stop automated processing lines associated with the syringe 10, such as those for automatically filling the syringe 10 with medication / pharmaceuticals, until one or more syringes 10 can be removed from the nest, resulting in undesirable downtime and maintenance costs, as well as potential damage to one or more syringes 10. The RFID element 62, embedded in the rigid cap 60, increases the outer diameter OD between the inner molded portion 64 and the outer molded portion 66. SC .

[0044] When using the rigid cap 60, it should be recognized that features are desirable to include on the rigid cap to facilitate threaded engagement of the rigid cap 60 with the adapter 29 (i.e., to mate the threaded outer surface 78 of the connecting portion 72 with the threaded inner surface 33 of the adapter 29). While these features are typically set as splines (which are circumferentially spaced around and extend radially from the outer surface 96 of the outer molded portion 66, and allow for the application of tightening torque to the rigid cap 60 using a torsion tool (i.e., a process tightening tool) engaged with the splines), the inclusion of such splines may be prohibited due to the diameter limitations of the rigid cap 60, especially for embedding the RFID element 62 between the inner molded portion 64 and the outer molded portion 66 in the rigid cap 60 and the resulting increase in cap diameter. In some cases, the outer diameter OD SC The maximum size can be approximately 10.9 mm.

[0045] In response to the foregoing, various aspects and embodiments of this disclosure relate to including a plurality of end teeth 102 on a rigid cap 60, which extend axially from the distal end 63 of the cap 60 (from the distal end 63 of the housing 67), i.e., extending along the longitudinal direction L of the rigid cap 60. Similar to the splines described above, the teeth 102 allow a torsion tool to engage with the rigid cap 60 and allow the torsion tool to apply a tightening torque to the cap 60. However, the teeth 102 are formed on the rigid cap 60 such that they do not extend radially beyond the outer surface 96 of the outer molded portion 66, but instead allow the torsion tool to engage with the rigid cap 60 at the distal end 63 (front end) of the rigid cap.

[0046] like Figure 3 and Figure 4As shown, according to one aspect or embodiment of this disclosure, each of the inner molding portion 64 and the outer molding portion 66 includes a plurality of teeth 102 formed at its distal ends 70, 100, the plurality of teeth extending axially from the distal ends 70, 100. The plurality of teeth 102 are circumferentially spaced around the inner molding portion 64 and the outer molding portion 66, and in some embodiments, the plurality of teeth 102 are equidistant from each other. The teeth 102 on the inner molding portion 64 are circumferentially aligned with the teeth 102 on the outer molding portion 66 such that the teeth 102 on the inner molding portion 64 and the teeth 102 on the outer molding portion 66 overlap and engage with each other when formed as part of the molding process.

[0047] According to various aspects of this disclosure, the number of teeth 102 on the rigid cap 60 can vary, and the number of teeth 102 provided (at least partially) is determined by the configuration of the torsion tool used to secure the rigid cap 60 to the syringe barrel 12. Figures 3 to 5 In the embodiments, eight (8) teeth 102 are formed on the inner molding portion 64 and the outer molding portion 66, but it should be understood that more or fewer teeth 102 may be formed. For example, in Figure 6 and Figure 7 In one embodiment, four (4) teeth 102 are formed on the inner molded portion 64 and the outer molded portion 66. In other embodiments, the number of teeth 102 included on the rigid cap 60 can be any number from two (2) to sixteen (16) teeth 102.

[0048] In the use of the rigid cap 60, the teeth 102 are configured to provide a front engagement feature or surface that, when the cap is secured to the syringe barrel 12, i.e., when the threaded outer surface 78 of the connecting portion 72 on the inner molded portion 64 engages with the threaded inner surface of the adapter 29 on the syringe barrel 12, a torsion tool (i.e., a process tightening tool) can engage with the front engagement feature or surface to apply a tightening torque to the rigid cap 60. In some embodiments, the teeth 102 provide a crenellated front end surface that can engage with the torsion tool, wherein each tooth 102 has a generally rectangular shape, wherein the side edges 104 of the teeth 102 extend orthogonally from the distal end 70 of the inner molded portion 64 and the distal end 100 of the outer molded portion 66, and a flat distal edge 106 is arranged orthogonally to the side edges 104. Each tooth 102 may have a height (i.e., length) H between 0.5 mm and 3.0 mm. T The teeth 102 extend from the second ends 70, 100 at this height to provide proper engagement between the torsion tool and the teeth 102, and to enable the desired transmission of tightening torque from the torsion tool to the teeth 102 and the rigid cap 60. In other embodiments, each tooth 102 may have a triangular shape, a curved shape, or a wavy shape, and have a flat distal edge 106.

[0049] Although Figures 3 to 7 The embodiment of the rigid cap 60 shown illustrates that a plurality of teeth 102 are formed on each of the inner molding portion 64 and the outer molding portion 66; however, it should be understood that, according to an additional embodiment, only one of the inner molding portion 64 and the outer molding portion 66 may have teeth 102 formed thereon. In one example, as... Figure 8 and Figure 9 As shown, the teeth 102 are formed only on the inner molding portion 64, that is, formed as part of the first injection molding of the inner molding portion 64. In another example, as... Figure 10 and Figure 11 As shown, the teeth 102 are formed only on the outer molding portion 66, that is, formed as part of the second injection molding of the outer molding portion 66. In each of these embodiments, the thickness of the teeth 102 may be increased compared to the remainder of the inner molding portion 64 (i.e., the second end 70 of the inner molding portion) or the outer molding portion 66 (to which the teeth 102 form a part). The thickness of the teeth 102 should enable them to resist breakage when engaged by a torsion tool and when a tightening torque is applied via the torsion tool.

[0050] Furthermore, despite Figures 3 to 11 The embodiment of the rigid cap 60 shown is illustrated and described as being formed by a co-molding process and including an inner molded portion 64 and an outer molded portion 66; however, it should be understood that the rigid cap 60 (i.e., the housing 67 of the rigid cap 60) can be formed as a single integral part (i.e., formed by a single molding process). As described above, in embodiments where the housing 67 of the rigid cap 60 is formed as a single molded part, the RFID element 62 can be integrated on the inner or outer surface of the housing 67.

[0051] Now for reference Figures 12 to 14 An embodiment of a rigid cap 60 is provided, wherein an RFID element 62 is located on the inner surface of an integrally formed / molded housing 67, and the RFID element 62 is configured as a hard tag (“hard tag 62”) including a rigid housing member 110 and an encapsulated RFID tag 112. Figure 12 In one embodiment, the rigid housing member 110 of the hard label 62 is configured as a rigid sleeve, which is positioned within the cavity 87 of the housing 67 and fixed to the inner surface 114 of the housing 67 surrounding the cavity 87, for example, by gluing to the inner surface 114, fixing to the inner surface 114 via a snap-fit ​​feature, or forcibly mounted (i.e., press-fit or interference fit) onto the inner surface 114 to fix it to the inner surface of the housing. Although the hard label 62 is in Figure 12 The diagram shows a rigid shell member 110 with teeth formed thereon; however, it should be understood that the rigid shell member 110 can be replaced by a cylindrical member (with teeth 102 only on the shell 67). Figure 13In one embodiment, the rigid housing member 110 of the hard tag 62 is configured as a washer-shaped member (with the RFID tag 112 embedded therein), the washer-shaped member being positioned at the bottom of the cavity 87 and around the inner cap 65, wherein the inner cap 65 secures the hard tag 62 in place relative to the rigid cap 60. Figure 14 In some embodiments, the rigid housing member 110 of the hard tag 62 is configured as a disc-shaped member (in which the RFID tag 112 is embedded), which is positioned at the top of the cavity 87 and at the distal end of the inner cap 65. In some embodiments, a protective cover 116 is fitted into an opening 86 at the distal end of the housing 67 to protect the hard tag 62 and hold it in place relative to the rigid cap 60.

[0052] Now for reference Figure 15 An embodiment of a rigid cap 60 is provided, wherein an RFID element 62 is located on the outer surface of an integrally formed / molded housing 67. In one embodiment, such as Figure 15 As shown, the RFID element 62 can be configured as a directly printed antenna and a combined chip 118 disposed directly on the outer surface of the housing 67. In other embodiments, the RFID element 62 is configured as an overmolded tag 118 having in-mold electronics disposed on the outer surface of the housing 67.

[0053] Advantageously, embodiments of the invention thus provide a rigid cap having an integrated RFID tag and external torque transmission features formed thereon. The rigid cap is formed as a co-molded cap, with the RFID tag embedded within it, between different inner molded portions or layers and outer molded portions or layers. The rigid cap includes a plurality of axially extending front teeth formed thereon, which enable a torsion tool to engage with the cap, thereby providing the transmission of external torque through the cap for performing a torsional engagement of the cap with an associated connector on the syringe barrel. Because the teeth extend axially from the front / distal end of the rigid cap, rather than radially from the outer surface, the external dimensions of the rigid cap can be controlled while still allowing the RFID tag to be embedded within it.

[0054] While this disclosure has been described in detail for illustrative purposes based on embodiments or aspects currently considered most practical and preferred, it should be understood that such detailed description is for that purpose only, and that this disclosure is not limited to the disclosed embodiments or aspects. Rather, this disclosure is intended to cover modifications and equivalent arrangements within the spirit and scope of the appended claims. For example, it should be understood that this disclosure contemplates that, to the extent possible, one or more features of any embodiment may be combined with one or more features of any other embodiment.

Claims

1. A rigid cap for use with a syringe, said rigid cap comprising: A cap housing, the cap housing including a proximal end and a distal end and defining an internal cavity; as well as A radio frequency identification (RFID) element, said RFID element being integrated with the cap housing at the distal end; The cap housing includes a plurality of circumferentially spaced teeth extending axially from the distal end of the cap housing, wherein the teeth extend in the longitudinal direction of the cap and allow engagement with a torsion tool to apply torque to the teeth.

2. The rigid cap according to claim 1, wherein, The cap housing includes a first molded portion, wherein the RFID element is integrated on the inner surface of the first molded portion.

3. The rigid cap according to claim 1, wherein, The RFID element includes a hard tag comprising an RFID chip and an antenna encapsulated in a rigid sleeve, gasket, or disc, wherein the hard tag is positioned within the internal cavity of the cap housing and fixed to the inner surface of the cap housing.

4. The rigid cap according to claim 1, wherein, The cap housing includes a first molded portion, wherein the RFID element is integrated on the outer surface of the first molded portion.

5. The rigid cap according to claim 4, wherein, The RFID element includes an overmolded tag with in-mold electronics.

6. The rigid cap according to claim 1, wherein, The cap shell includes a first molded portion and a second molded portion, the second molded portion being integrated on the first molded portion and the RFID element at the distal end, so as to enclose the RFID element between the first molded portion and the second molded portion.

7. The rigid cap according to claim 6, wherein, The RFID element includes a flat RFID inlay that conforms to the cylindrical outer surface of the first molded portion.

8. The rigid cap according to claim 7, wherein, The RFID inlay includes a first edge and an opposing second edge, wherein the RFID inlay extends partially around the distal end of the first molded portion such that a gap exists between the first edge and the second edge, and wherein the second molded portion is in direct contact with the first molded portion at the location of the gap.

9. The rigid cap according to any one of claims 6 to 8, wherein, The plurality of circumferentially spaced teeth are provided on each of the first molded portion and the second outer portion.

10. The rigid cap according to claim 9, wherein, The plurality of teeth on the first molded portion are circumferentially aligned with and engaged with the plurality of teeth on the second molded portion.

11. The rigid cap according to any one of claims 6 to 10, wherein, The first radial thickness of the distal end of the first molded portion is between 0.2 mm and 1.0 mm, preferably between 0.5 mm and 0.8 mm, and the second radial thickness of the second molded portion is between 0.2 mm and 1.0 mm, preferably between 0.5 mm and 0.8 mm.

12. The rigid cap according to any one of claims 1 to 11, wherein, The height of each of the plurality of teeth is between 0.5 mm and 3.0 mm.

13. The rigid cap according to any one of claims 1 to 12, wherein, Each of the plurality of teeth includes a rectangular tooth, a triangular tooth, a curved tooth, or a wavy tooth with a flat distal end.

14. The rigid cap according to any one of claims 1 to 13, wherein, The plurality of teeth includes two to sixteen teeth, preferably four to eight teeth.

15. A syringe, the syringe comprising: A syringe barrel comprising a proximal end and a distal end and defining a chamber, the syringe barrel having an opening at the proximal end; A plunger assembly, inserted through the opening and axially movable within the chamber of the syringe barrel, the plunger assembly comprising: A plunger rod, the plunger rod comprising an elongated body and extending between a proximal end and a distal end; and A stop member, the stop member being attached to the distal end of the plunger rod and positioned within the cavity of the barrel; and The rigid cap according to any one of claims 1 to 14, wherein the rigid cap is coupled to the adapter at the distal end of the syringe barrel.

Images