Co-molded rigid cap with integrated RFID and cap end torque transmission function.

Abstract

Provided herein is a rigid cap comprising an inner molded portion having a proximal end and a distal end, the proximal end having an open end and including a female connector formed thereon, and the distal end having a closed end. The rigid cap also comprises an RFID element positioned on the inner molded portion of the distal end so as to extend around at least a portion of the distal end, and an outer molded portion formed on the inner molded portion of the distal end and on the RFID element, enclosing the RFID element between the inner and outer molded portions, the outer molded portion having a proximal end and a distal end. The inner and / or outer molded portions include a plurality of circumferentially spaced teeth extending axially outward from their distal end.

Description

Technical Field

[0001] The present disclosure generally relates to rigid caps such as syringes, and more specifically to rigid caps having an integrated RFID tag and a torque transmission function formed thereon.

Background Art

[0002] This application claims priority to European Application No. 23305855.1, filed May 30, 2023, entitled "Co-molded Rigid Cap with Integrated RFID and Cap End Torque Transmission Function", the entire disclosure of which is incorporated herein by reference.

[0003] Syringes are used in a variety of environments for administering liquids such as drugs or medications to patients. Many syringes are provided as prefilled syringes, which provides the convenience of being able to quickly administer a liquid to a patient without having to aspirate the drug from another container and measure its volume. To distribute the fluid, a prefilled syringe typically includes a syringe barrel having an opening at a distal end suitable for fluid communication with the patient (e.g., a luer-type fitting (needleless access device) attached to the distal end of the syringe barrel and connected to the patient's fluid line), and a plunger assembly inserted through the proximal end on the opposite side of the barrel. The plunger assembly typically includes an elongated plunger rod extending out of the barrel and a plunger head or stopper disposed at the distal end of the plunger rod. The stopper or plunger stopper typically includes a body having a tail disposed at its proximal end adapted to be attached to the distal end of the plunger rod and a head disposed at its distal end. The outer cylindrical wall of the body defines a plurality of annular outwardly projecting ribs adapted to ensure the integrity of the container closure of the syringe when the stopper is inserted into the syringe.

[0004] When using pre-filled syringes, it is desirable to label the pre-filled syringes to include data about the syringe and / or the contents contained within the syringe (in other words, the drug), and in some embodiments, to enable tracking of the syringe. In other words, it is desirable to have the ability to track the history of individual syringes or many syringes from early in the manufacturing cycle to the final use of the device. Syringe identification and / or tracking may be provided through the use of an electronic element on which data is included and which can conventionally be read and read in a non-contact manner. For example, syringe identification and tracking can be enabled by incorporating an electronic component such as an RFID tag into the syringe. In some known syringes, the RFID tag is incorporated into a rigid cap located above the opening of the syringe barrel at the distal end, such as a cap that connects to a Luer fitting at the distal end of the syringe barrel. The RFID tag may be embedded within the rigid cap for protection, and this embedding into the cap is achieved by a co-forming process for forming the rigid cap. [Overview of the project] [Problems that the invention aims to solve]

[0005] While integrating RFID tags into rigid caps for syringe identification and / or tracking is known, existing rigid caps with integrated RFID tags may have issues related to the functionality of the rigid cap. For example, batches of syringes are typically packaged, stored, and shipped in storage containers known as “nests,” and it may be necessary to control the size / diameter of the rigid cap to allow machines to automatically position and / or withdraw the syringes in and / or out of the nest without interference. However, while co-molding RFID tags into rigid caps may achieve the desired functionality of the cap, it may present challenges in controlling the diameter of the cap. Specifically, it is desirable to include splines ("spline teeth") on the outer surface of the rigid cap that extend radially outward and can be gripped and twisted via an associated twisting tool in order to secure the cap to the syringe, but including an RFID tag may reduce the space available on the rigid cap for forming such spline teeth. Therefore, the radial height of the spline teeth is reduced to keep the rigid cap below the required dimensional limits, and the reduction in spline height and the amount by which it protrudes radially outward from the adjacent cap outer surface may adversely affect the transmission of external torque from the torsion tool to the rigid cap when securing the cap to the syringe.

[0006] Therefore, in this field, there is a technical need for a rigid cap that incorporates an RFID tag while also enabling efficient transmission of external torque. [Means for solving the problem]

[0007] This specification provides a rigid cap for use with a syringe. The rigid cap includes a cap housing having a proximal and 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 outward from its distal end.

[0008] In a particular configuration, the cap housing includes a first molded portion, and the RFID element is integrated onto the inner surface of the first molded portion.

[0009] In a particular configuration, the RFID element is a hard tag that includes an RFID chip and an antenna enclosed in a rigid sleeve, washer, or disk.

[0010] In a particular configuration, the cap housing includes a first molded portion, and the RFID element is integrated onto the outer surface of the first molded portion.

[0011] In certain configurations, the RFID element is an over-molded tag with an in-mold electronic component.

[0012] In a particular configuration, the cap housing includes a first molded portion and a second molded portion, the second molded portion being integrated on the first molded portion and on the RFID element at its distal end, and housing the RFID element between the first molded portion and the second molded portion.

[0013] In a particular configuration, the RFID element is a flat RFID inlay that fits onto the outer surface of the cylinder of the first molded portion.

[0014] In a particular configuration, the RFID inlay includes a second end opposite to a first end, and the RFID inlay extends to partially surround the distal end of the first molded portion, thereby creating a gap between the first and second ends, where the second molded portion is in direct contact with the first molded portion.

[0015] In a particular configuration, multiple teeth, spaced apart in the circumferential direction, are provided on both the first molded portion and the second outer portion.

[0016] In a particular configuration, multiple teeth of the first molded portion are aligned circumferentially with and joined to multiple teeth of the second molded portion.

[0017] In a particular configuration, the distal end of the first molded portion has a first radial thickness of 0.2 mm to 1.0 mm, preferably 0.5 mm to 0.8 mm, and the second molded portion has a second radial thickness of 0.2 mm to 1.0 mm, preferably 0.5 mm to 0.8 mm.

[0018] In a particular configuration, each of the multiple teeth has a height of 0.5 mm to 3.0 mm.

[0019] In a particular configuration, each of the multiple teeth comprises a rectangular, triangular, curved, or wavy tooth with a flat distal end.

[0020] In a particular configuration, the multiple teeth consist of 2 to 16 teeth, preferably 4 to 8 teeth.

[0021] Furthermore, this specification provides a syringe comprising a syringe barrel having a proximal and distal end and defining a chamber, the syringe barrel having an opening at its proximal end. The syringe also includes a plunger assembly inserted through the opening and movable axially within the chamber of the syringe barrel, the plunger assembly comprising a plunger rod having an elongated body and extending between the proximal and distal ends, and a stopper attached to the distal end of the plunger rod and positioned within the barrel chamber. In addition, the syringe includes a rigid cap having a proximal and distal end and comprising a cap housing defining an internal cavity, and having an RFID element integrated with the cap housing at the distal end. The cap housing comprises a plurality of circumferentially spaced teeth extending axially outward from its distal end. The rigid cap is coupled to an adapter at the distal end of the syringe barrel. [Brief explanation of the drawing]

[0022] [Figure 1] Figure 1 is a perspective view of a syringe embodying an embodiment of the present disclosure. [Figure 2]Figure 2 is an exploded view of the syringe of Figure 1. [Figure 3] Figure 3 is a perspective view of the rigid cap included in the syringe of Figure 1 according to a non-limiting embodiment described herein. [Figure 4] Figure 4 is a side cross-sectional view of the rigid cap of Figure 3 showing the state of being coupled to the male connector of the syringe. [Figure 5] Figure 5 is a perspective view of the molded portion inside the rigid cap of Figure 3 where the RFID tag is disposed. [Figure 6] Figure 12 is an exploded perspective view of the rigid cap included in the syringe of Figure 1 according to another non-limiting embodiment described herein. [Figure 7] Figure 15 is a perspective view of the molded portion inside the rigid cap of Figure 12 where the RFID tag is disposed. [Figure 8] Figure 18 is a perspective view of the rigid cap included in the syringe of Figure 1 according to another non-limiting embodiment described herein. [Figure 9] Figure 21 is a perspective view of the molded portion inside the rigid cap of Figure 18 where the RFID tag is disposed. [Figure 10] Figure 24 is a perspective view of the rigid cap included in the syringe of Figure 1 according to another non-limiting embodiment described herein. [Figure 11] Figure 27 is a perspective view of the molded portion inside the rigid cap of Figure 24 where the RFID tag is disposed. [Figure 12] Figure 30 is an exploded perspective view of the rigid cap included in the syringe of Figure 1 according to another non-limiting embodiment described herein. [Figure 13] Figure 33 is a side cross-sectional view of the rigid cap included in the syringe of Figure 1 according to another non-limiting embodiment described herein. [Figure 14] Figure 36 is a side cross-sectional view of the rigid cap included in the syringe of Figure 1 according to another non-limiting embodiment described herein. [Figure 15]Figure 15 is a perspective view of the rigid cap included in the syringe of Figure 1, according to another non-limiting embodiment described herein. [Modes for carrying out the invention]

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

[0024] Hereinafter, for illustrative purposes, “top,” “bottom,” “right,” “left,” “vertical,” “horizontal,” “upper surface,” “lower surface,” “lateral direction,” “vertical direction,” and their derivatives shall be used in reference to the orientation of the invention as described herein in the drawings. However, it should be understood that the invention may be based on various alternative modifications unless expressly specified otherwise. It should also be understood that the specific devices shown in the accompanying drawings and described herein are merely exemplary embodiments of the invention. Therefore, specific dimensions and other physical characteristics relating to the embodiments disclosed herein should not be construed as limiting.

[0025] In this specification, the distal end of a component or device means the end furthest from the user's hand when the component or device is in the use position, in other words, when the user is holding the syringe and preparing or using it, and the proximal end means the end closest to the user's hand. Similarly, in this specification, the terms “distal direction” and “distal” mean the direction toward the distal tip of the syringe, and the terms “proximal direction” and “proximal” mean the direction opposite to the direction toward the distal tip of the syringe.

[0026] Aspects and embodiments of the present disclosure relate to an integrated RFID tag and a rigid cap having a torque transmission function formed thereon. The rigid cap is formed as a co-molded cap with the RFID tag embedded between different molded portions or layers of the cap. The rigid cap includes a front or distal end feature formed on the cap that allows an external torque applied to the cap, such as through a process of twisting or torsion of a tool that can engage with the cap, to be transmitted through the cap for torsional engagement between the cap and the associated connection on a syringe barrel.

[0027] Referring to Figures 1 and 2, non-limiting embodiments of syringe 10, such as a pre-filled syringe, are shown, on which aspects or embodiments of the present disclosure can be implemented. Syringe 10 generally includes a syringe barrel 12 and a plunger assembly 14. The plunger assembly 14 is axially movable within the syringe barrel 12 and moves to an advanced position, for example, to facilitate the administration of an injectable fluid (e.g., a drug) to a patient.

[0028] The syringe barrel 12 is formed from a generally cylindrical outer wall 16 and end wall 18, which together define a chamber 20 for holding fluid inside. The syringe barrel 12 includes an open proximal end 22 configured to receive a plunger assembly 14 therein, and a distal end 24 where the end wall 18 is located. The proximal end 22 of the syringe barrel 12 may be provided with a flange 26 to facilitate handling and positioning of the syringe 10 and to maintain the relative position of the syringe barrel 12 and the plunger assembly 14 during drug administration. At the distal end 24, the tip 28 extends distally outward from the end wall 18 and defines a lumen 30 that is in fluid communication with the chamber 20. A Luer lock adapter 29 is attached to the outer surface of the tip 28 and can be coupled to a rigid cap 60 covering the tip 28 and / or a corresponding needle hub (not shown) into which the syringe 10 is engaged for drug administration to a patient. The adapter 29 has a cylindrical body and a threaded inner surface 33, which is configured to engage with the threaded portion of the rigid cap 60, as described later. Although a specific adapter 29 is shown and described herein, it is recognized that the syringe 10 can be provided with adapters of various structures known in the art to connect the syringe 10 to a corresponding needle hub and to discharge the injectable material to a target position.

[0029] The plunger assembly 14 of the syringe 10 consists of an elongated plunger rod 32 (hereinafter more commonly referred to as "plunger 32") and a plunger head or stopper 34. The plunger 32 may include a body 36 extending between the proximal end 38 and the distal end 40 of the plunger. In some embodiments, the body 36 may include a plurality of elongated vanes or walls 42 extending axially along the length between the proximal end 38 and the distal end 40 of the plunger. A thumb press 44 is positioned on the proximal end 38 of the plunger, and the user's thumb (or other fingers) can engage with it to apply distal force to the plunger assembly 14, moving the plunger 32 relative to the syringe barrel 12. In some embodiments, a flanged extension member 46 (e.g., a disc-shaped flange) is positioned on the distal end 40 of the plunger, configured to connect with the stopper 34.

[0030] The stopper 34 of the plunger assembly 14 is positioned at the distal end 40 of the plunger and is movable with the plunger 32 within the chamber 20 of the syringe barrel 12. The stopper 34 is formed of a material different from that of the plunger 32 and is capable of forming a tight seal with the syringe barrel 12 when pushed into the syringe barrel 12. In some embodiments, the stopper 34 has an internal receiving portion (not shown) sized and configured to receive a flanged extension member 46 of the plunger 32, the flanged extension member 46 being coupled to the receiving portion, for example, via a press-fit connection to secure the stopper 34 to the plunger 32. However, it can be understood that the mounting member 48 and the distal end 40 of the plunger may also be secured by other techniques well known to those skilled in the art. The mounting member 48 may further include a pair of spaced annular flanges 58 (in other words, O-rings) formed thereon, which form a tight seal with the cylindrical outer wall 16 of the syringe barrel 12.

[0031] As shown in Figures 1 and 2, the syringe 10 further includes a rigid cap 60 that is coupled to an adapter 29 of the syringe barrel 12, thereby protecting the tip 28 from contamination and / or keeping the chamber 20 sealed before use of the syringe 10. The rigid cap 60 is configured as a rigid cap that couples with the adapter 29 and is capable of providing a fluid-tight seal over the tip 28, with the proximal end 61 of the rigid cap 60 configured to engage with the adapter 29, and the distal end 63 (in other words, the “front end”) configured to be closed by an inner cap 65 (“RiTC”) made of elastomer, forming a closed rigid cap 60 that covers the tip 28.

[0032] According to aspects and embodiments of the present disclosure, and as further illustrated below in detail in Figures 3 to 15 based on various aspects of the present disclosure, the rigid cap 60 incorporates an RFID element or tag 62 that enables the identification and / or tracking of the syringe 10. In other words, the RFID element 62 enables tracking of the syringe 10 by holding or recording information about the contents of the syringe 10 (in other words, the drug or medicine contained therein in the case of a pre-filled syringe) and the manufacturing history of the syringe, and / or providing location information to an associated reader. According to embodiments, the RFID element 62 may be provided on a portion of the inner or outer surface of the rigid cap 60, or embedded within the rigid cap 60, as will be further described below.

[0033] According to the embodiments, the RFID element 62 may be provided in any of the various forms that enable integration with the rigid cap 60. In some embodiments, the RFID element 62 may be an inlay including a chip or integrated circuit (IC), an antenna, and a substrate (in other words, a film surface) (see Figures 3 to 11). In other embodiments, the RFID element 62 may be a hard tag including an RFID chip and an antenna encapsulated in a rigid sleeve, washer, or disk (see Figures 12 to 14). In other embodiments, the RFID element 62 may be a printed tag including an antenna directly printed on a 3D component having an adhesive chip, or an overmolded tag using in-mold electronics technology (see Figure 15).

[0034] According to the embodiment, it is recognized that the RFID element 62 can be any type of tag available to those skilled in the art. In other words, those skilled in the art will clearly understand that other tags other than RFID may also be used. For example, the tag may be a low-frequency radio frequency identification (LF-RFID) tag (in other words, a frequency between 30 kHz and 300 kHz). The RFID tag may also be a high-frequency radio frequency identification (HF-RFID) tag (in other words, a frequency between 1 MHz and 15 MHz), a very high-frequency radio frequency identification (UHF-RFID) tag (in other words, a frequency between 400 MHz and 1,000 MHz), or a dual-frequency tag that includes both HF-NFC and UHF RFID simultaneously. Alternatively, the RFID tag may be a high-frequency near-field communication (HF-NFC) tag (in other words, a frequency between 1 MHz and 15 MHz).

[0035] A rigid cap 60 according to one aspect or embodiment of the present disclosure is shown in more detail in Figures 3 to 5. The rigid cap 60 is formed as a rigid cap formed by a molding process such as an injection molding process. When the rigid cap 60 includes a first molded portion 64 ("inner molded portion") and a second molded portion 66 ("outer molded portion"), the rigid cap 60 is formed as a co-molded cap formed through two separate molding processes, where the inner molded portion 64 is formed during the first molding shot or process, and the outer molded portion 66 is formed during the second molding shot or process. The inner molded portion 64 and the outer molded portion 66 are each formed from a material suitable for molding, such as polypropylene, polyethylene, polyvinyl chloride, polystyrene, polycarbonate, acrylonitrile-butadiene-styrene, styrene-acrylonitrile, or similar polymers, or combinations thereof. The inner molded portion 64 and the outer molded portion 66 may collectively define the cap housing 67 of the rigid cap 60. The inner molded portion 64 and the outer molded portion 66 together can define the cap housing 67 of the rigid cap 60. As will be further described below, in the manufacture of the rigid cap 60, the second molded portion 66 is formed on a part of the inner molded portion 64, and the RFID element 62 is integrated between the inner molded portion 64 and the outer molded portion 66.

[0036] As best shown in Figures 4 and 5, 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 suitable for coupling with the adapter 29 or syringe 10. As previously stated, in some embodiments, the distal end 24 of the syringe barrel 12 includes a tip 28 on which the adapter 29 is fixed / mounted, and in such embodiments, the connecting portion 72 is configured to couple with the adapter 29. The connecting portion 72 may include a cylindrical portion 76 having a threaded outer surface 78 configured to engage with the threaded inner surface 33 of the adapter 29, the cylindrical portion 76 defining an opening 82 into which a portion of the elastomer inner cap 65 can be inserted.

[0037] In some embodiments, the annular flange 84 may be formed on an 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 (and between the proximal end 68 and the distal end 70) of the inner molded portion 64 so 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 abuts against the distal end of the adapter 29, thereby providing a sealed engagement between the rigid cap 60 and the syringe barrel 12.

[0038] The distal end 70 of the inner molded portion 64 is configured as an open end that receives an elastomer inner cap 65 therein, which seals the distal end 70 of the rigid cap 60. In other words, the inner molded portion 64 may be formed to include a cylindrical wall 90 defining a circular opening 86 at its distal end 70, and the inner cap 65 is fitted into the opening 86 and extends into a cavity 87 defined by the inner molded portion 64.

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

[0040] The inner cap 65 comprises a proximal skirt 88 having a hollow cylindrical shape that may be slightly tapered to conform to the tapered shape of the tip 28 of the syringe 10, and a distal seal base 89 that forms an inner cavity having a substantially circular shape adapted to engage with the tip 28 of the syringe 10 and which may present a central projection or nipple 91 surrounded by the skirt 88. The central projection 91 extends proximal from the distal seal base 89 and is centrally located relative to the distal seal base. The central projection 91 can slightly penetrate the distal end of the tip 28 of the syringe 10 (in other words, into the lumen 30). The inner diameter of the skirt 88 is selected so that it stretches slightly radially when the skirt is attached to 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 inner cap 65, with its precise shape and elastomer material, provides a liquid-tight seal to the tip 28 of the syringe 10, preventing leakage and / or contamination of the medical solution.

[0041] In embodiments of the rigid cap 60 shown in Figures 3 to 5, the RFID element 62 of the rigid cap 60 is applied to or installed on the outer surface 92 of the side wall 90 at the distal end 70 of the inner molded portion 64. According to the embodiments, the RFID element 62 can conform to the cylindrical outer surface 92 of the side wall 90 and at least substantially wrap around it. In some embodiments, the RFID element 62 is configured to surround most of the side wall 90 but not completely cover it, and a gap 94 exists between the first end 95a of the RFID element 62 and the opposing second end 95b. According to the embodiments, the RFID element 62 may be bonded to the cylindrical outer surface 92 of the side wall 90 or bonded to the outer surface 92 via bonding with molten plastic in order to help hold the RFID element 62 in place.

[0042] As shown in Figures 3 and 4, after molding the inner molded portion 64, the RFID element 62 is attached to the distal end 70 of the inner molded portion 64, and then the outer molded portion 66 is formed (in other words, molded) on top of the inner molded portion 64 and the RFID element 62 to complete the manufacture of the rigid cap 60. The outer molded portion 66 is formed to cover the inner molded portion 64 and the RFID element 62 at the distal end 70 of the inner molded portion 64, thereby sealing the RFID element 62 between the inner molded portion 64 and the outer molded portion 66. The outer molded portion 66 is formed as a generally tubular member surrounding the distal end 70 of the inner molded portion 64 and has a generally cylindrical outer surface 96. In some embodiments, the outer molded portion 66 includes a proximal end 98 positioned adjacent to the annular flange 84 and a distal end 100 positioned adjacent to and / or substantially coaxial with the distal end 70 of the inner molded portion 64. According to embodiments, the outer molded portion 66 and the inner molded portion 64 may each have a radial thickness of 0.2 mm to 1.0 mm, preferably 0.5 mm to 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. Also, in embodiments in which the RFID element 62 is only partially wrapped around the side wall 90, the outer molded portion 66 is in direct contact with the inner molded portion 64 at the location of the gap 94, so that a bond is formed between the inner molded portion 64 and the outer molded portion 66.

[0043] According to aspects of this disclosure, the outer diameter of the rigid cap 60, outer diameter OD SCIt is recognized that this may be constrained based on the packaging requirements of the syringe 10. In other words, batches of syringes 10 are typically packaged, filled, stored, and / or shipped in nests having a number of chimneys, which are known to hold the syringes. Removal of the syringes 10 from this nest is performed by sliding the syringes 10 axially relative to the nest, and if the rigid cap 60 exceeds a certain diameter, the syringes 10 may get stuck in the chimneys during withdrawal from the nest. Therefore, an automated processing line associated with the syringes 10, such as for automatically filling the syringes 10 with drugs / medicines, would need to be stopped until the syringes 10 can be removed from the nest, which could result in undesirable downtime and maintenance costs, as well as potential damage to the syringes 10. Embedding the RFID element 62 between the inner molded portion 64 and the outer molded portion 66 within the rigid cap 60 is possible due to the outer diameter OD SC Increase.

[0044] In the use of the rigid cap 60, it is recognized that it is desirable to include features in the rigid cap 60 that facilitate torsion engagement of the rigid cap 60 with the adapter 29 (in other words, coupling the threaded outer surface 78 of the connecting portion 72 with the threaded inner surface 33 of the adapter 29). Such features are generally provided as splines spaced circumferentially around the outer surface 96 of the outer molded portion 66 and extending radially from there, allowing the use of a torsion tool (in other words, a process threading tool) to engage the splines and apply threading torque to the rigid cap 60. However, the incorporation of such splines may be hindered based on the diameter constraints of the rigid cap 60, particularly the embedding of RFID elements 62 between the inner molded portion 64 and the outer molded portion 66, and the resulting increase in the diameter of the cap. In some cases, the outer diameter OD SC The maximum dimension can be approximately 10.9 mm.

[0045] In response to the above, aspects and embodiments of the present disclosure relate to providing a plurality of end teeth 102 on the rigid cap 60 that extend axially outward from the distal end 63 of the cap 60 (the distal end 63 of the housing 67) (in other words, outward in 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 transmit screwing torque to the cap 60. However, the teeth 102 are formed on the rigid cap 60 such that they do not extend radially outward beyond the outer surface 96 of the outer molded portion 66, but rather at their distal end 63 (front end) to provide engagement of the torsion tool with the rigid cap 60.

[0046] As shown in Figures 3 and 4, according to one aspect or embodiment of the present disclosure, each of the inner molded portion 64 and the outer molded portion 66 is provided with a plurality of teeth 102 formed at their distal ends 70, 100 and extending axially outward from there. The teeth 102 are spaced apart around the circumference of the inner molded portion 64 and the outer molded portion 66, and in some embodiments, the teeth 102 are arranged to be equally spaced from one another. The teeth 102 on the inner molded portion 64 are circumferentially aligned with the teeth 102 on the outer molded portion 66, and as they are formed as part of the molding process, the teeth 102 on the inner molded portion 64 and the outer molded portion 66 overlap and join with each other.

[0047] According to embodiments of this disclosure, the number of teeth 102 provided on the rigid cap 60 may vary, and the number of teeth 102 provided is determined (at least partially) by the configuration of the torsion tool used to secure the rigid cap 60 to the syringe barrel 12. In the embodiments of Figures 3 to 5, eight teeth 102 are formed on the inner molded portion 64 and the outer molded portion 66, but it is recognized that the number of teeth 102 may be more or less than this. For example, in the embodiments of Figures 6 and 7, four 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 in the rigid cap 60 may be any from 2 to 16.

[0048] In the use of the rigid cap 60, the teeth 102 are configured to provide a front-end engagement feature or surface for a torsion tool (in other words, a threading tool) to engage with and apply threading torque to the rigid cap 60 when securing the cap to the syringe barrel 12, in other words, when engaging the threaded inner surface of the adapter 29 on the syringe barrel 12 with the threaded outer surface 78 of the connecting portion 72 on the inner molded portion 64. In some embodiments, the teeth 102 provide a forked front surface into which a torsion tool can engage. The teeth 102 have a generally rectangular shape, and the side ends 104 of the teeth 102 extend orthogonally from the distal ends 70, 100 of the inner molded portion 64 and the outer molded portion 66, with a flat distal end 106 positioned orthogonally to the side ends 104. The teeth 102 have a height (in other words, length), H T The teeth have a height of 0.5 mm to 3.0 mm. This allows the teeth 102 to protrude from the second ends 70, 100, ensuring proper engagement between the torsion tool and the teeth 102, and enabling the transmission of the desired screwing torque from the torsion tool to the teeth 102 and the rigid cap 60. In other embodiments, each of the teeth 102 may have a triangular, curved, or wavy shape with a flat distal end 106.

[0049] In the embodiments of the rigid cap 60 shown in Figures 3 to 7, multiple teeth 102 are formed on both the inner molded portion 64 and the outer molded portion 66. However, according to additional embodiments, it is recognized that the teeth 102 may be formed on only one of the inner molded portion 64 or the outer molded portion 66. As an example, as shown in Figures 8 and 9, the teeth 102 are formed only on the inner molded portion 64, in other words, as part of the primary molding of the inner molded portion 64. As another example, as shown in Figures 10 and 11, the teeth 102 are formed only on the outer molded portion 66, in other words, as part of the secondary molding of the outer molded portion 66. In each of these embodiments, the thickness of the teeth 102 can be increased compared to the rest of the inner molded portion 64 (in other words, its second end 70) or the outer molded portion 66 to which the teeth 102 constitute. The thickness of tooth 102 must be such that it can withstand breakage when engaged with a torsion tool and when screwing torque is applied through the torsion tool.

[0050] Furthermore, while embodiments of the rigid cap 60 shown in Figures 3 to 11 are shown and described as being formed via a co-molding process and including an inner molded portion 64 and an outer molded portion 66, it is recognized that the rigid cap 60 (in other words, the housing 67 of the rigid cap 60) is formed as a single, integrated structure (in other words, formed by a single molding process). As shown above, in embodiments in which the housing 67 of the rigid cap 60 is formed as a single molded part, the RFID element 62 may be integrated into the inner or outer surface of the housing 67.

[0051] Referring here to Figures 12 to 14, an embodiment is provided in which the RFID element 62 is disposed on the inner surface of a rigid cap 60 integrally formed / molded housing 67, and the RFID element 62 is provided as a hard tag ("hard tag 62") including a rigid housing member 110 and an encapsulated RFID tag 112. In the embodiment of Figure 12, the rigid housing member 110 of the hard tag 62 is disposed within a cavity 87 of the housing 67 and constitutes a rigid sleeve fixed to the inner surface 114 of the housing 67 surrounding the cavity 87, and is fixed by bonding to the inner surface 114, fixing to the inner surface 114 via a snap-fit ​​function, or press-fitting into the inner surface 114 (in other words, press-fit or interferential coupling). The hard tag 62 shown in Figure 12 is shown to include a rigid housing member 110 with teeth formed thereon, but the rigid housing member 110 may instead be formed as a cylindrical member (with only the housing 67 having teeth 102). In the embodiment shown in Figure 13, the rigid housing member 110 of the hard tag 62 is configured as a washer-shaped member (with the RFID tag 112 embedded) positioned at the bottom of the cavity 87 and around the inner cap 65, with the inner cap 65 fixing the hard tag 62 in a predetermined position relative to the rigid cap 60. In the embodiment shown in Figure 14, the rigid housing member 110 of the hard tag 62 is configured as a disc-shaped member (with the RFID tag 112 embedded) located at the upper part of the cavity 87 and the distal end of the inner cap 65. In some embodiments, a protective cover 116 is coupled to an opening 86 at the distal end of the housing 67 to protect the hard tag 62 and fix it in a predetermined position relative to the rigid cap 60.

[0052] Referring here to Figure 15, an embodiment is provided in which the RFID element 62 is disposed on the outer surface of a rigid cap 60 integrally formed / molded housing 67. In one embodiment, as shown in Figure 15, the RFID element 62 may consist of a directly printed antenna and a bonded chip 118 directly provided on the outer surface of the housing 67. In another embodiment, the RFID element 62 is provided as an over-molded tag 118 with in-mold electronic components on the outer surface of the housing 67.

[0053] Advantageously, embodiments of the present invention provide a rigid cap that integrates an RFID tag and forms an external torque transmission feature. The rigid cap is formed as a co-molded cap with the RFID tag embedded, the tag positioned between clearly distinguished inner and outer molded portions or layers of the cap. The rigid cap has a plurality of axially extending front-end teeth, which allow a torsion tool to be coupled to the cap, enabling the transmission of external torque through the cap and performing a torsional engagement between the cap and the associated connection on the syringe barrel. Because the teeth extend axially outward from the front / distal end of the rigid cap and not radially outward from the outer surface, it is possible to control the external dimensions of the rigid cap while allowing the RFID tag to be embedded inside.

[0054] While this disclosure is described in detail based on the most practical and preferred embodiments or aspects currently available, such details are for illustrative purposes only and should be understood as being intended to include modifications and equivalent configurations within the spirit and scope of the appended claims, rather than limiting this disclosure to the disclosed embodiments or aspects. For example, it should be understood that, to the extent possible, this disclosure is intended to allow for the combination of one or more features of any embodiment with one or more features of other embodiments.

Claims

1. A rigid cap for a syringe, wherein the rigid cap is A cap housing having a proximal end and a distal end, defining an internal cavity, A radio frequency identification (RFID) element comprising a radio frequency identification (RFID) element integrated into the cap housing at the distal end, The cap housing comprises a plurality of teeth spaced circumferentially, extending axially outward from its distal end, the teeth extending along the longitudinal direction of the cap and transmitting torque by engagement with a torsion tool, wherein the cap is a rigid cap for a syringe.

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

3. The rigid cap according to claim 1, wherein the RFID element is a hard tag comprising an RFID chip and an antenna enclosed in a rigid sleeve, washer, or disk, and the hard tag is disposed within the internal cavity of the cap housing and fixed to its inner surface.

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

5. The rigid cap according to claim 4, wherein the RFID element comprises an over-molded tag having an in-mold electronic component.

6. The rigid cap according to claim 1, wherein the cap housing includes a first molded portion and a second molded portion, the second molded portion being integrated with the first molded portion and the RFID element at the distal end, and the RFID element being housed between the first molded portion and the second molded portion.

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

8. The rigid cap according to claim 7, wherein the RFID inlay includes a second end opposite to the first end, and the RFID inlay extends to partially surround the distal end of the first molded portion, thereby creating a gap between the first end and the second end, and 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 teeth arranged at intervals in the circumferential direction are provided on the first molded portion and the second outer portion, respectively.

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

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

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

13. The rigid cap according to any one of claims 1 to 12, wherein each of the plurality of teeth comprises a rectangular, triangular, curved, or corrugated tooth having a flat distal end.

14. The rigid cap according to any one of claims 1 to 13, wherein the plurality of teeth have 2 to 16 teeth, preferably 4 to 8 teeth.

15. It is a syringe, A syringe barrel having a defined chamber and a proximal end and a distal end, wherein the syringe barrel has an opening at the proximal end, A plunger assembly inserted through the opening and movable axially within the chamber of the syringe barrel, wherein the plunger assembly is A plunger rod comprising a slender body and a plunger rod extending between a proximal end and a distal end, A syringe barrel comprising a plunger assembly including a stopper which is attached to the distal end of the plunger rod and disposed within the barrel chamber, A syringe comprising a rigid cap according to any one of claims 1 to 14, wherein the rigid cap is coupled to an adapter at the distal end of the syringe barrel.

Images