Rigid syringe cap with integrated RFID and torque transmission features, molded in one piece.

Abstract

A syringe cap is provided, comprising an inner molded portion having a first end and a second end, the first end being an open end and having a female connector formed at the open end, and the second end being a closed end. The syringe cap further comprises an RFID element positioned at the second end of the inner molded portion. The syringe cap comprises an outer molded portion formed on the inner molded portion and the RFID element at the second end, thereby sealing the RFID element between the inner and outer molded portions. The outer molded portion has an outer surface having a plurality of spline teeth that are spaced apart in the circumferential direction and extend radially outward from the outer surface, the spline teeth having sufficient height to allow torque to be transmitted from a torsion tool to the syringe cap when tightening the cap.

Description

[Technical Field]

[0001] This disclosure relates in general to syringe caps, and more particularly to syringe caps having an integrated RFID tag and torque transmission feature.

[0002] This application claims priority under European Application No. 23305856.9, filed on 30 May 2023, entitled “Integrated Rigid Syringe Cap with Integrated RFID and Torque Transmission Features,” the entirety of which disclosure is incorporated herein by reference. [Background technology]

[0003] Syringes are used in a variety of environments to administer liquids, such as pharmaceuticals and other medications, to patients. Many syringes are supplied as pre-filled syringes, which offer the convenience of rapidly delivering the liquid inside to the patient without the need to draw the medication from another container and measure its volume. To dispense the fluid, a pre-filled syringe typically comprises a syringe barrel with a distal opening adapted for fluid communication with the patient (e.g., a Luer 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 outward from the barrel and a plunger head or stopper positioned at the distal end of the plunger rod. The stopper or plunger stopper is typically made of an elastomer material and comprises a body with a tail positioned at the proximal end of the stopper for attachment to the distal end of the plunger rod, and a head positioned at the distal end of the body. The outer cylindrical wall of the main body is defined with multiple annular outward projections that are adapted to ensure the integrity of the syringe container closure when the stopper is inserted into the syringe.

[0004] When using pre-filled syringes, it is desirable to include data about the syringe and / or the contents contained within the syringe (i.e., the drug), and, in some embodiments, to enable syringe tracking. That is, it is desirable to have the ability to track the history of individual syringes or syringe lots from the early stages of the manufacturing process to the final use of the device. Syringe identification and / or tracking is achieved by using electronic components that hold data and are normally readable and writable in a contactless manner. For example, syringe identification and tracking can be achieved by incorporating electronic components such as RFID tags into the syringe. In some known syringes, the RFID tag is incorporated into a rigid syringe cap located on the opening at the distal end of the syringe barrel, and the syringe cap is, for example, a cap that fits into a Luer fitting provided at the distal end of the syringe barrel. The RFID tag is embedded within the syringe cap for protection, and this embedding into the cap is achieved by an integral molding process for forming the syringe cap.

[0005] While it is well known that RFID tags can be integrated into syringe caps for syringe identification and / or tracking, existing syringe caps integrated with RFID tags may have functional challenges related to the functionality of the syringe cap. For example, syringes are typically packaged, stored, and transported in batches in storage containers called "nests," and the dimensions of the syringe cap, particularly its diameter, need to be controlled to allow for automatic insertion and / or removal of syringes into and out of the nests without interference. However, when incorporating RFID tags into syringe caps by a two-stage molding process, it can be difficult to control the diameter while providing the cap with the desired functionality. Specifically, it is desirable to provide splines ("spline teeth") on the outer surface of the syringe cap to securely fasten the cap to the syringe by gripping and twisting the cap with an associated twisting tool (i.e., it is desirable for the female Luer connector on the cap to engage with the male Luer connector on the syringe barrel). However, integrating RFID tags into the syringe cap reduces the available space for forming spline teeth on the syringe cap. Therefore, to keep the syringe cap within the required dimensional constraints, the spline tooth height is reduced. This reduction in spline tooth height and the amount of protrusion from adjacent cap surfaces can negatively affect the transmission of external torque from the torsion tool to the syringe cap when securing the cap to the syringe. For example, some existing caps have spline tooth heights of 0.30 mm, and such spline tooth heights can negatively impact the transmission of external torque from the torsion tool to the syringe cap when securing the cap to the syringe.

[0006] As another example, it is recognized that placing an RFID tag between the two molded parts of a syringe cap can cause adhesion problems in the cap. Specifically, because there is a difference in material between the first molded part and the first surface of the RFID tag, and between the second molded part and the second surface of the RFID tag, delamination occurs between the molded parts and the RFID tag when external torque is applied to the cap, impairing the integrity of the syringe cap. Such delamination may reduce the torque transmitted from the torsion tool through the syringe cap (i.e., internal torque transmission) to fit the cap onto the syringe barrel. [Overview of the project] [Problems that the invention aims to solve]

[0007] Therefore, a syringe cap with a structure that allows for efficient transmission of both external and internal torque while incorporating an RFID tag is required by those skilled in the art. [Means for solving the problem]

[0008] This specification provides a syringe cap for use with a syringe. The syringe cap has a first end and a second end, and comprises an inner molded portion defining an internal space, the first end being an open end and having a female connector formed thereon, and the second end being a closed end. The syringe cap comprises a radio frequency identification (RFID) element positioned on the second end of the inner molded portion and positioned to extend around at least a portion of the second end. Furthermore, the syringe cap comprises an outer molded portion formed on the second end of the inner molded portion and on the RFID element, the outer molded portion sealing the RFID element between the inner and outer molded portions. The outer molded portion has an outer surface including a plurality of spline teeth that are spaced circumferentially and extend radially outward from the outer surface, the plurality of spline teeth having a height of 0.400 mm or more radially outward from the outer surface.

[0009] In one configuration, each of the multiple spline teeth extends from the outer surface by a range of 0.400 mm to 0.750 mm.

[0010] In one configuration, the second end of the inner molded portion has a circumferential outer surface, and the outer diameter of the second end is approximately 9.75 mm.

[0011] In one configuration, the female connector has a threaded outer surface configured to engage with the male connector, and the height of multiple spline teeth allows the second end to engage with a screw tool to screw the threaded outer surface of the female connector into the male connector.

[0012] In one configuration, the inner molded portion includes an annular flange formed distal to the threaded outer surface between the first and second ends.

[0013] In one configuration, the RFID element includes a flat RFID inlay that fits the cylindrical outer surface of the first end of the inner molded portion.

[0014] In one configuration, the second end of the inner molded portion is provided with a rib formed on its cylindrical outer surface, the rib extending radially outward from the cylindrical outer surface.

[0015] In one configuration, the rib is equipped with an angle locator, the RFID element is positioned relative to the angle locator, and the RFID element is positioned on the cylindrical outer surface of the second end so as not to overlap with the rib.

[0016] In one configuration, the outer molded portion is formed on top of the inner molded portion which includes ribs, and the ribs create interference between the inner and outer molded portions.

[0017] In one configuration, the radially outward-facing surface of the rib has a concave shape.

[0018] In one configuration, the outer molded portion is formed on top of the inner molded portion, excluding the ribs, the ribs are not covered by the outer molded portion, and the radially outward-facing surface of the ribs is flush with the outer surface of the outer molded portion.

[0019] In one configuration, the outer molding part is formed on the inner molding part except for the rib, the rib is not covered by the outer molding part, and a part of the rib extends radially outward beyond the outer surface of the outer molding part and extends to a height equal to the height of the plurality of spline teeth.

[0020] Also provided herein is a syringe, the syringe having a proximal end and a distal end and having a syringe barrel defining a chamber, the syringe barrel having an opening at the proximal end. The syringe further includes a plunger assembly inserted into the opening and axially movable within the chamber of the syringe barrel, the plunger assembly including an elongated body, a plunger rod extending between the proximal end and the distal end, and a stopper attached to the distal end of the plunger rod and disposed within the chamber of the barrel. The syringe further includes a syringe cap having a first end and a second end and including an inner molding part defining an internal cavity, the first end being an open end and having a female connector formed thereon, the second end being a closed end. The syringe cap further includes a radio frequency identification (RFID) element disposed on the second end of the inner molding part and extending around at least a portion of the second end. The syringe cap further includes an outer molding part, the outer molding part being formed on the second end of the inner molding part and on the RFID element to enclose the RFID element between the inner molding part and the outer molding part, the outer molding part having an outer surface including a plurality of spline teeth, the plurality of spline teeth being circumferentially spaced apart and extending radially outward from the outer surface. The female connector of the inner molding part is coupled to a male connector provided at the distal end of the syringe barrel.

[0021] Also provided herein is a method of forming an integrally molded syringe cap. The method includes a step of molding an inner cap portion having a first end and a second end and defining an internal cavity, the first end being an open end and having a female connector formed thereon, the second end being a closed end. The method further includes a step of installing a radio frequency identification (RFID) element on the second end of the inner molded portion, the RFID element being installed to extend along at least a portion of the circumference of the second end. The method further includes a step of molding an outer cap portion over the second end of the inner molded portion and over the RFID element to encapsulate the RFID element between the inner cap portion and the outer cap portion, the outer cap portion having an outer surface, the outer surface being circumferentially spaced and having a plurality of spline teeth extending radially outward therefrom. The plurality of spline teeth have a height of 0.400 mm or more extending radially outward from the outer surface.

[0022] In one configuration, by molding the outer cap portion, each of the plurality of spline teeth extends from the outer surface in the range of 0.400 mm to 0.750 mm.

[0023] In one configuration, by molding the inner cap portion, the second end of the inner molded portion has a circumferential outer surface and an outer diameter of the second end is about 9.75 mm.

[0024] In one configuration, the inner cap portion is formed with ribs on the cylindrical outer surface of the inner cap portion, the ribs extending radially outward from the cylindrical outer surface.

[0025] In one configuration, the outer molded portion is molded over the inner molded portion including the ribs, and the ribs form an interference between the inner molded portion and the outer molded portion.

[0026] In one configuration, the outer molded portion is molded over the inner molded portion except for the ribs, the ribs are not covered by the outer molded portion, and the radially outward surface of the ribs is flush with the outer surface of the outer molded portion or extends radially outward beyond the outer surface of the outer molded portion to a height equal to the height of the plurality of spline teeth.

[0027] In one configuration, the RFID element is positioned on the cylindrical outer surface of the second end, so as not to overlap with the rib, the rib is an angle locator, and the RFID element is positioned relative to the angle locator.

[0028] Furthermore, a syringe cap for use with a syringe is also provided herein. The syringe cap comprises a first end and a second end, and includes an inner molded portion defining an internal cavity, the first end being an open end and including a female connector formed thereon, and the second end being a closed end. The syringe cap further comprises a radio frequency identification (RFID) element positioned on the second end of the inner molded portion and extending around at least a portion of the second end. The syringe cap further comprises an outer molded portion, which is formed on the second end of the inner molded portion and on the RFID element, encapsulating the RFID element between the inner and outer molded portions, and the outer molded portion has an outer surface including a plurality of spline teeth, the plurality of spline teeth being spaced circumferentially and extending radially outward from the outer surface. The second end of the inner molded portion has a rib formed on its cylindrical outer surface, the rib extending radially outward from the cylindrical outer surface to form an interference between the inner and outer molded portions.

[0029] In one configuration, the rib is equipped with an angle locator, the RFID element is positioned relative to the angle locator, and the RFID element is positioned on the cylindrical outer surface of the second end so as not to overlap with the rib.

[0030] In one configuration, the outer molded portion is formed on top of the inner molded portion, which includes ribs.

[0031] In one configuration, the outer molded portion is formed on top of the inner molded portion, excluding the ribs, the ribs are not covered by the outer molded portion, and the radially outward-facing surface of the ribs is flush with the outer surface of the outer molded portion.

[0032] In one configuration, the outer molded portion is formed on top of the inner molded portion, except for the ribs, the ribs are not covered by the outer molded portion, and a portion of the ribs extends radially outward beyond the outer surface of the outer molded portion to a height equal to the height of the multiple spline teeth. [Brief explanation of the drawing]

[0033] [Figure 1] This is a perspective view of a syringe used in implementing an embodiment of the present disclosure. [Figure 2] Figure 1 is an exploded view of the syringe. [Figure 3] This is a perspective view showing the syringe cap of Figure 1 with the end wall removed, according to a non-limiting embodiment described herein. [Figure 4] Figure 3 is a side cross-sectional view showing the syringe cap connected to the male connector of the syringe. [Figure 5] Figure 3 is a perspective view of the inner molded portion of the syringe cap where the RFID tag is placed. [Figure 6] This is a perspective view showing the syringe cap of the syringe in Figure 1 with the end wall removed, according to another non-limiting embodiment described herein. [Figure 7] Figure 6 is a perspective view showing the state in which an RFID tag is placed on the inner molded part of the syringe cap. [Figure 8] This is a perspective view showing the syringe cap of the syringe in Figure 1 with the end wall removed, according to another non-limiting embodiment described herein. [Figure 9] Figure 8 is a perspective view showing the state in which an RFID tag is placed on the inner molded part of the syringe cap. [Figure 10] This is a perspective view showing the syringe cap of the syringe in Figure 1 with the end wall removed, according to another non-limiting embodiment described herein. [Figure 11] Figure 10 is a perspective view showing the state in which an RFID tag is placed on the inner molded part of the syringe cap. [Figure 12]This is a perspective view showing the syringe cap with the end wall removed from the syringe shown in Figure 1, according to another non-limiting embodiment described herein. [Figure 13] Figure 12 is a perspective view showing the state in which an RFID tag is placed on the inner molded part of the syringe cap. [Modes for carrying out the invention]

[0034] The following description is provided so that embodiments intended to carry out the present invention may be made and used by those skilled in the art. However, various modifications, equivalents, variations, and substitutions may be readily conceived by those skilled in the art. All such modifications, variations, equivalents, and substitutions are intended to fall within the spirit and scope of the present invention.

[0035] In the following description, “up,” “down,” “right,” “left,” “vertical,” “horizontal,” “upper,” “lower,” “lateral,” “longitudinal,” and their derivatives refer to the relationship between the present invention and the orientation shown in the drawings. However, unless otherwise explicitly specified, it should be understood that the present invention may take various alternative forms. It should also be understood that the specific devices shown in the accompanying drawings and described in the following specification are merely illustrative embodiments of the present invention. Therefore, specific dimensions and other physical characteristics relating to the embodiments disclosed herein should not be constrained.

[0036] In this disclosure, the distal end of a component or device means the end of the component or device that is furthest from the user's hand when the user is holding the syringe before or during use, and the proximal end means the end that is closest to the user's hand. Similarly, in this application, the term “distal direction” means the direction toward the distal tip of the syringe, and the term “proximal direction” means the direction opposite to the direction of the distal tip of the syringe.

[0037] Aspects and embodiments of the present disclosure relate to syringe caps having integrated RFID tags and torque transmission features. The syringe cap is formed as a single-molded cap in which the RFID tag is embedded between different molded parts or layers of the cap. The syringe cap comprises internal and external features which apply torque to the cap (e.g., via a torsion or screw-in tool that can engage with the cap) and transmit torque through the cap, thereby enabling torsional engagement between the cap and the associated connection of the syringe barrel.

[0038] Referring to Figures 1 and 2, non-limiting embodiments of syringe 10, such as a pre-filled syringe, are shown that can carry out aspects or embodiments of the present disclosure. Syringe 10 generally comprises a syringe barrel 12 and a plunger assembly 14. The plunger assembly 14 is axially movable within the syringe barrel 12 and can be moved to an advanced position, for example, to facilitate the administration of an injectable fluid (e.g., a drug) to a patient.

[0039] The syringe barrel 12 is formed from a substantially cylindrical outer wall 16 and an end wall 18, which together define a chamber 20 for holding fluid inside. The syringe barrel 12 has an open proximal end 22 configured to accommodate a plunger assembly 14 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 with respect to the plunger assembly 14 during drug administration. At the distal end 24, a nozzle 28 extends distally outward from the end wall 18 and defines a lumen 30 that communicates fluid with the chamber 20. In some embodiments, the nozzle 28 forms part of a Luer connector (i.e., a male Luer connector) that can be connected to a corresponding needleless connector (not shown) into which the syringe 10 is engaged for administering drug to a patient. Those skilled in the art will understand that other types of connection configurations are provided for securing the distal end 24 of the syringe barrel 12 in order to discharge the injectable material to a desired location.

[0040] The plunger assembly 14 of the syringe 10 consists of an elongated plunger rod 32 (hereinafter also 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, which can be engaged by the user's thumb (or other fingers), is positioned at the proximal end 38 of the plunger, thereby applying a distal force to the plunger assembly 14 and 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 at the distal end 40 of the plunger, configured to engage with the stopper 34. In another embodiment, the distal end 40 of the plunger is formed with a female receiving portion configured to receive and connect to a projection (e.g., a pin) extending proximal from the stopper, and the projection and the receiving portion engage, for example, via a screw.

[0041] 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 may be formed from a different material than the plunger 32 and can form a tight seal with the syringe barrel 12 as the syringe barrel 12 advances. In some embodiments, the stopper 34 includes a receiving portion (not shown) sized and configured to receive a flanged extension member 46 of the plunger 32, the flanged extension member 46 which connects to the receiving portion, for example, via a press-fit connection, to secure the stopper 34 to the plunger 32. However, as will be understood by those skilled in the art, the mounting member 48 and the distal end 40 of the plunger may be secured by other known techniques. Furthermore, the mounting member 48 may comprise a pair of annular flanges 58 (i.e., O-rings) formed spaced apart from each other, which tightly seal with the cylindrical outer wall 16 of the syringe barrel 12.

[0042] As shown in Figures 1 and 2, and also in Figures 3 to 5, the syringe 10 further includes a syringe cap 60 that can be coupled to the nozzle 28 of the syringe barrel 12, the syringe cap 60 for protecting the nozzle 28 from contamination and / or for keeping the chamber 20 sealed before use of the syringe 10. The syringe cap 60 is configured as a rigid cap positioned around the nozzle 28 and configured to form a fluid-seal seal to the nozzle 28. According to aspects and embodiments of the present disclosure, as will be described in more detail below, the syringe cap 60 incorporates an RFID element 62 that enables identification and / or tracking of the syringe 10. That is, the RFID element 62 may include or store information about the contents of the syringe 10, i.e., (in the case of a pre-filled syringe) information about the drug or pharmaceutical contained in the syringe 10, and / or the RFID element 62 is configured to provide location information to an associated reader, thereby enabling tracking of the syringe 10.

[0043] Figures 3 to 5 further illustrate a syringe cap 60 according to one aspect or embodiment of the present disclosure. The syringe cap 60 is formed as a rigid, integrally molded cap formed by two separate molding processes. That is, an inner molded portion 64 ("inner cap portion") is formed during a first molding shot or molding process, and an outer molded portion 66 ("outer cap portion") is formed during a second molding shot or molding process. Thus, the inner molded portion 64 and the outer molded portion 66 are each formed from a moldable material, such as a polymer material, which can be manufactured by injection molding. According to some aspects or embodiments, the polymer material forming the inner molded portion 64 and / or the outer molded portion 66 may include a transparent or translucent material. As will be further described below, in the manufacture of the syringe cap 60, the outer molded portion 66 is formed on a portion of the inner molded portion 64, and the RFID element 62 is embedded between the inner molded portion 64 and the outer molded portion 66.

[0044] As best shown in Figures 4 and 5, the inner molded portion 64 of the syringe cap 60 can be defined as generally including a first end 68 and a second end 70. The first end 68 is configured as an open end, and a connector 72 suitable for connection to the syringe barrel 12 is formed on the first end 68. As previously mentioned, in some embodiments, the distal end of the syringe barrel 12 is provided with a nozzle 28 that forms part of a male (Luer) connector 74, and in such embodiments, the connector 72 provided on the first end 68 of the inner molded portion 64 can be configured as a female (Luer) connector (hereinafter, "female connector 72") configured to mate with the male connector 74, as shown in Figure 4. The female connector 72 may include a cylindrical portion 76 having a threaded outer surface 78 configured to engage with the inner surface of the threaded collar 80 of the male connector 74. The cylindrical portion 76 defines an opening 82 into which the tapered nozzle 28 of the male connector 74 is received.

[0045] An annular flange 84 may be formed on the inner molded portion 64 adjacent to the threaded outer surface 78 of the female connector 72. The annular flange 84 is positioned distal to the first end 68 of the inner molded portion 64 (between the first end 68 and the second end 70), and when the threaded outer surface 78 engages with the threaded collar 80 of the male connector 74, the annular flange 84 abuts against the end of the male connector 74, thereby providing a sealed engagement between the syringe cap 60 and the syringe barrel 12.

[0046] The second end 70 of the inner molded portion 64 is configured as a closed end and, together with the first end 68, defines a space 86 within the syringe cap 60. The second end 70 is formed from an end wall 88 and a continuous side wall 90 that jointly provide the closed end of the inner molded portion 64. The side wall 90 provides a substantially cylindrical outer surface 92 on the second end 70, while the inner circumferential surface 94 of the side wall 90 defines a portion of the space 86 within the inner molded portion 64.

[0047] The RFID element 62 of the syringe cap 60 is installed or positioned on the outer surface 92 of the side wall 90 at the second end 70 of the inner molded portion 64. The RFID element 62 is provided in the form of a generally flat, two-dimensional RFID tag or inlay (hereinafter, "RFID tag 62"). Although not shown, the RFID tag 62 includes an RFID antenna, which is positioned on an antenna foil and fixed to a chip module having a carrier foil, the chip module preferably positioned between two foils. According to the embodiment, the RFID tag 62 is formed along the cylindrical outer surface 92 of the side wall 90 and can wrap at least substantially around it.

[0048] As shown in Figures 3 and 4, the inner molded portion 64 is molded, and the RFID tag 62 is attached to the second end 70 of the inner molded portion 64. Then, the outer molded portion 66 is formed (i.e., molded) on the inner molded portion 64 and the RFID tag 62 to complete the manufacture of the syringe cap 60. The outer molded portion 66 is formed on the second end 70 of the inner molded portion 64 and on the RFID tag 62, enclosing the RFID tag 62 between the inner molded portion 64 and the outer molded portion 66. The outer molded portion 66 is formed as a substantially cylindrical tubular member surrounding the second end 70 of the inner molded portion 64. The outer molded portion 66 has an outer surface 96 on which a plurality of spline teeth 98 are formed. The spline teeth 98 are spaced apart along the perimeter of the outer surface 96 of the outer molded portion 66, and in some embodiments, the spline teeth 98 are spaced equally apart from each other. Each spline tooth 98 extends radially outward from the outer surface 96, and in some embodiments, at least some of the spline teeth 98 are configured such that at least one side wall 100 extending between the outer surface 96 and the top surface or radially outward-facing surface 102 of the spline tooth 98 is perpendicular to the outer surface 96. The side walls 100 of the spline teeth 98 thus oriented perpendicularly form a surface which engages with a screwing tool (e.g., a screwing tool) when fixing the syringe cap 60 to the syringe barrel 12 (i.e., when engaging the threaded outer surface 78 of the female connector 72 formed on the inner molding portion 64 with the threaded collar 80 of the male connector 74 provided on the syringe barrel 12), thereby applying screwing torque from the screwing tool to the syringe cap 60.

[0049] To ensure proper engagement between the torsion tool and the spline teeth 98 and to enable the transmission of the desired screwing torque from the torsion tool to the spline teeth 98, each spline tooth 98 is positioned above a height H that exceeds a minimum height that would adversely affect torque transmission. ST It is desirable to have the above. As mentioned above, some syringe caps in the prior art have spline teeth with a height of 0.300 mm, but this height is insufficient to enable the transmission of the desired screwing torque from the torsion tool to the spline teeth. According to an aspect of the present disclosure, the spline teeth 98 have a height H STis preferably 0.400 mm or more, and the maximum height H of the spline teeth 98 ST As will be described later, it is recognized that the maximum outer diameter of the syringe cap 60 (for example, 10.9 mm) limits the maximum height H of the spline teeth 98. Therefore, in some embodiments, the height H of the spline teeth 98 ST is in the range of 0.400 mm to 0.750 mm, and the height H ST of the spline teeth 98 having a height of 0.575 mm is a preferred example. In other words, as indicated by the above spline tooth dimensions, the spline teeth 98 have a height H corresponding to 133% to 250% of the spline tooth height in a known syringe cap ST and desirably have.

[0050] According to an aspect of the present disclosure, the outer diameter of the syringe cap 60, that is, the outer diameter OD SC is recognized to be restricted based on the packaging requirements of the syringe 10. That is, batches of syringes 10 are known to be packaged, stored, and / or shipped in a nest in which a number of chimneys for accommodating the syringes are formed. The removal of the syringe 10 from this nest is performed by sliding the syringe 10 axially with respect to the nest. If the syringe cap 60 exceeds a predetermined diameter, the syringe 10 may become stuck in the chimney when removed from the nest. As a result, an automated processing line associated with the syringe 10, such as automatically filling the syringe 10 with a drug / chemical, needs to be stopped until the syringe 10 is removed from the nest, which causes an undesirable increase in downtime and maintenance costs, and also risks damage to the syringe 10.

[0051] While satisfying the diameter constraints described above, in order to manufacture the syringe cap 60 while maintaining the desired spline tooth height H in the range of 0.400 mm to 0.750 mm ST in an aspect of the present disclosure, the inner molding portion 64 is molded such that its outer diameter, that is, the outer diameter of the outer surface 92 of the inner molding portion 64 (hereinafter referred to as the "inner molding portion outer diameter OD IMPIt is provided that this is done in a manner that controls the following. That is, it is recognized that the inner molded portion 64 and the outer molded portion 66 of the syringe cap 60 need to have an appropriate thickness in order to embed the RFID tag 62 between them and to maintain the structural integrity of the syringe cap 60. However, the outer diameter of the inner molded portion 64, i.e., the outer diameter OD, IMP If it is excessively large, then inevitably the outer diameter of the outer molded portion 66, i.e., the outer diameter OD of the outer surface 96 of the outer molded portion 66 will be affected. OMP This also increases. As a result, the overall outer diameter OD of the syringe cap 60 increases. SC To keep the spline teeth 98 below a predetermined maximum diameter, ST Therefore, it becomes necessary to reduce the desired height H while maintaining the desired thickness for the inner molded part 64 and the outer molded part 66. ST In order to enable the formation of spline teeth 98 having the outer diameter OD, in an embodiment of the present disclosure, the inner molding portion 64 is made of the outer diameter OD IMP and the thickness T of the inner molded portion 64 IMP The objective is to mold in a manner that reduces the inner diameter IDIMP of the inner molded portion 64 (i.e., the diameter of the inner surface 94 of the inner molded portion 64 at the second end 70) while maintaining the desired level. According to the embodiment, the desired thickness T is achieved by adding material to the inner surface 94 side during the molding process. IMP An inner molded portion 64 having the outer diameter OD of the inner molded portion 64 is obtained. IMP It is formed to a size of approximately 9.75 mm ± 0.25 mm. Outer diameter OD of the inner molded part 64 IMP By maintaining the outer diameter OD of the outer molded portion 66 below the desired value, IMP Similarly, it becomes possible to maintain this value below the desired value. As a result, a sufficient height H is maintained on the outer molded portion 66. ST It is possible to form spline teeth 98 having such spline teeth 98, and it is possible to efficiently transmit screwing torque to the syringe cap 60 via the spline teeth 98.

[0052] Referring to Figures 6 and 7, syringe caps 110 according to further aspects or embodiments of the present disclosure are shown. The features of cap 110 can be combined with the features of syringe caps 60 shown and described in Figures 3 to 5. Syringe caps 110 in Figures 6 and 7 have substantially the same structure as caps 60 in Figures 3 to 5, and similar components are therefore numbered the same. However, syringe cap 110 includes ribs 112 formed in the inner molded portion 64, which will be described in more detail below.

[0053] As best shown in Figure 7, the second end 70 of the inner molded portion 64 of the syringe cap 110 has a continuous side wall 90 that forms a substantially cylindrical outer surface 92 on the second end 70. However, a rib 112 extending radially outward is formed on the cylindrical outer surface 92. In some embodiments, the rib 112 extends longitudinally along the inner molded portion 64 from the edge 114 of the second end 70 to the annular flange 84. According to some aspects of the present disclosure, as shown in Figures 6 and 7, the rib 112 is formed such that its radially outward-facing surface 116 is substantially flat. According to other aspects of the present disclosure, as shown in Figures 8 and 9, the rib 112 is formed such that its radially outward-facing surface 116 has a concave shape.

[0054] According to some aspects of this disclosure, an angle locator is provided when applying / positioning the RFID tag 62 to the inner molded portion 64 by forming a rib 112 on the outer surface 92 of the second end 70 of the inner molded portion 64. That is, when applying the RFID tag 62 to the inner molded portion 64, the RFID tag 62 is positioned relative to the rib 112, so that the RFID tag 62 is wound around most of the cylindrical outer surface 92 of the second end 70, not positioned on the rib 112, and not overlapping with the rib 112. Thus, the rib 112 functions as a simple and efficient angle locator during the manufacture of the syringe cap 110, and the RFID tag 62 is positioned relative to that angle locator.

[0055] By providing the rib 112 in the configuration shown in Figures 6 and 7, and / or the configuration shown in Figures 8 and 9, the second molding step for forming the outer molded portion 66 can be carried out such that the outer molded portion 66 is formed on the inner molded portion 64 including the rib 112. By forming the outer molded portion 66 on the inner molded portion 64 and the rib 112 in this way, the rib 112 provides interference between the inner molded portion 64 and the outer molded portion 66, which helps to hold the outer molded portion 66 in the inner molded portion 64. That is, the rib 112 functions as a spline between the inner molded portion 64 and the outer molded portion 66, extending radially outward from the remaining portion of the outer surface 92 of the second end 70 of the inner molded portion 64 and extending into the gap 118 formed in the outer molded portion 66 around the rib 112. As a result, the ribs 112 resist the shear force between the outer molded portion 66 and the inner molded portion 64 that may occur when screwing torque is applied to the outer molded portion 66 (by a torsion tool). Furthermore, the molding polymer material constituting the ribs 112 of the inner molded portion 64 comes into direct contact with the molten polymer material supplied during the molding of the outer molded portion 66, thereby improving the internal adhesion between the inner molded portion 64 and the outer molded portion 66. Welding of the same material occurs at the contact surface (i.e., surface 116) between the ribs 112 and the outer molded portion 66. The adhesion between the ribs 112 of the inner molded portion 64 and the outer molded portion 66 is stronger than the adhesion that may occur between the inner and outer surfaces of the RFID tag 62 and the inner and outer molded portions 64 and 66, eliminating the need for expensive double-sided lamination (i.e., a process of adding a thin layer of molding material to the RFID tag 62 separately from the first and second molding processes) required to improve the wettability of the RFID tag 62. This improves the overall integrity of the syringe cap 110 and reduces its cost.

[0056] Referring next to Figures 10 and 11, a syringe cap 120 is shown that is a further aspect or embodiment of the present disclosure, and the syringe cap 120 includes ribs 122 with a different structure from the ribs 112 of the syringe cap 110 in Figures 6 and 7 and / or Figures 8 and 9. In the syringe cap 120 of Figures 10 and 11, the ribs 122 have a different structure from the ribs 112 of the syringe cap 110 in Figures 6 and 7 and / or Figures 8 and 9. As shown in Figures 10 and 11, the ribs 122 formed on the inner molded portion 64 have increased thickness / height compared to the ribs 112 of the syringe cap 110, and as a result, when the outer molded portion 66 is molded on the inner molded portion 64, the outer molded portion 66 is formed on the inner molded portion 64 excluding the ribs 122, and the ribs 122 are not covered by the outer molded portion 66. Instead, the thickness / height of the rib 122 is configured such that when the outer molded portion 66 is formed on the inner molded portion 64 (excluding the rib 122), the radially outward-facing surface 116 of the rib 122 becomes flush with the outer surface 96 of the outer molded portion 66.

[0057] As described above, the rib 122 helps to hold the outer molded portion 66 to the inner molded portion 64 by forming an interference between the inner molded portion 64 and the outer molded portion 66. That is, the rib 122 extends radially outward from the rest of the outer surface 92 of the second end 70 of the inner molded portion 64 and enters into the gap 118 formed in the outer molded portion 66 around the rib 122, thereby functioning as a spline between the inner molded portion 64 and the outer molded portion 66. Thus, the rib 122 resists the shear force between the outer molded portion 66 and the inner molded portion 64 that may occur due to the screwing torque applied to the outer molded portion 66 (by a torsion tool). Furthermore, the rib 122 improves the internal adhesion between the inner molded portion 64 and the outer molded portion 66 by direct contact between the molten polymer material applied during the molding of the outer molded portion 66 and the molding polymer material constituting the rib 122 of the inner molded portion 64, and a welded portion made of the same material is formed between the contact surface (i.e., side) of the rib 122 and the outer molded portion 66.

[0058] Referring next to Figures 12 and 13, a syringe cap 126 according to an additional aspect or embodiment of the present disclosure is shown, the syringe cap 126 comprising a rib 128 having a different structure from the rib 112 of the cap 110 in Figures 6 and 7 (or Figures 8 and 9), and the rib 122 of the cap 120 in Figures 10 and 11. In the syringe cap 126 of Figures 12 and 13, as shown in Figures 12 and 13, the rib 128 formed on the inner molded portion 64 has a greater thickness / height than the rib 122 of the syringe cap 120, and as a result, the rib 128 is not covered by the outer molded portion 66 when the outer molded portion 66 is molded on the inner molded portion 64, and at least a portion of the rib 128 extends radially outward beyond the outer surface 96 of the outer molded portion 66, with respect to the height H of the multiple spline teeth 98 on the outer molded portion 66. ST It has a thickness / height that extends to a height equal to [a certain value].

[0059] As described above, the rib 128 provides interference and adhesion between the inner molded portion 64 and the outer molded portion 66, and also functions as a spline tooth of the syringe cap 126. First, as described above, the rib 128 functions as a spline between the inner molded portion 64 and the outer molded portion 66, resisting the shear force between the outer molded portion 66 and the inner molded portion 64 caused by the screwing torque applied to the outer molded portion 66 (by a torsion tool). In addition, the molding polymer material of the rib 128 of the inner molded portion 64 comes into direct contact with the molten polymer material applied when the outer molded portion 66 is molded, thereby improving the internal adhesion between the inner molded portion 64 and the outer molded portion 66. Next, the rib 128 extends radially outward from its outer surface, and the height H of the multiple spline teeth 98 formed on the outer molded portion 66 ST Extending to a height equivalent to that of the rib, the rib 128 is configured to engage with a torsion tool and to transmit screwing torque from the tool to the syringe cap 126, thereby securing the syringe cap 126 to the syringe barrel 12 (i.e., enabling screw engagement between the female connector 72 of the cap and the male connector of the syringe barrel 12).

[0060] Advantageously, according to each embodiment of the present invention, a syringe cap is provided in which an RFID tag is integrated and a torque transmission feature is formed thereon. The syringe cap is formed as a single-piece molded cap with the RFID tag embedded between mutually distinct inner and outer molded parts, or layers. The syringe cap includes an internal feature and an external feature that allows torque applied to the cap via a torsion tool or the like that can engage with the cap to be transmitted to the entire cap, thereby screw-engaging the cap with a connector corresponding to the syringe barrel. The internal and external dimensions of the syringe cap are controlled to appropriately embed the RFID tag, and the syringe cap is provided with spline teeth of sufficient height to efficiently transmit external torque to the cap. The syringe cap may include a rib structure that improves the bonding between the mutually distinct inner and outer molded parts or layers of the cap and resists shear forces inside the cap, thereby enabling efficient torque transmission inside the cap.

[0061] This disclosure has been described in detail for illustrative purposes based on the most practical and preferred embodiments or aspects at present. However, such details are for illustrative purposes only, and this disclosure is not limited to the embodiments or aspects disclosed, but rather is intended to encompass modifications and equivalent configurations that fall within the spirit and scope of the appended claims. For example, this disclosure assumes, to the extent possible, that one or more features of any embodiment may be combined with one or more features of any other embodiment.

Claims

1. A syringe cap for use with syringes, The syringe cap is, An inner molded portion comprising a first end and a second end, defining an internal space, wherein the first end includes an open end and includes a female connector formed thereon, and the second end includes a closed end, A radio frequency identification (RFID) element is positioned on the second end of the inner molded portion and extends around at least a portion of the second end; An outer molded portion, the outer molded portion is formed on the second end of the inner molded portion and on the RFID element, enclosing the RFID element between the inner molded portion and the outer molded portion, the outer molded portion has an outer surface including a plurality of spline teeth, the plurality of spline teeth are spaced apart in the circumferential direction and extend radially outward from the outer surface, and Equipped with, The aforementioned plurality of spline teeth have a height of 0.400 mm or more that extends radially outward from the outer surface. The syringe cap includes an RFID element which is a flat RFID inlay that fits the cylindrical outer surface of the second end of the inner molded portion.

2. The syringe cap according to claim 1, characterized in that each of the plurality of spline teeth extends from the outer surface in a range of 0.400 mm to 0.750 mm.

3. The syringe cap according to claim 1 or 2, characterized in that the second end of the inner molded portion has a circumferential outer surface, and the outer diameter of the second end is approximately 9.75 mm.

4. The syringe cap according to any one of claims 1 to 3, wherein the female connector has a threaded outer surface configured to engage with a male connector, and the height of the plurality of spline teeth allows the second end to be engaged with a twisting tool to screw the threaded outer surface of the female connector to the male connector.

5. The syringe cap according to any one of claims 1 to 4, characterized in that the inner molded portion is provided with an annular flange formed distal to the threaded outer surface between the first end and the second end.

6. The syringe cap according to any one of claims 1 to 5, characterized in that the second end of the inner molded portion is provided with a rib formed on its cylindrical outer surface, and the rib extends radially outward from the cylindrical outer surface.

7. The syringe cap according to claim 6, characterized in that the rib is provided with an angle locator, the RFID element is positioned relative to the angle locator, and the RFID element is positioned on the cylindrical outer surface of the second end such that it does not overlap with the rib.

8. The syringe cap according to claim 6 or 7, characterized in that the outer molded portion is formed on the inner molded portion including the ribs, and the ribs form interference between the inner molded portion and the outer molded portion.

9. The syringe cap according to claim 8, characterized in that the radially outward-facing surface of the rib has a concave shape.

10. The syringe cap according to claim 6 or 7, characterized in that the outer molded portion is formed on the inner molded portion except for the ribs, the ribs are not covered by the outer molded portion, and the radially outward-facing surface of the ribs is flush with the outer surface of the outer molded portion.

11. The syringe cap according to claim 6 or 7, characterized in that the outer molded portion is formed on the inner molded portion except for the ribs, the ribs are not covered by the outer molded portion, and a portion of the ribs extends radially outward beyond the outer surface of the outer molded portion to a height equal to the height of the plurality of spline teeth.

12. A syringe barrel having a proximal end and a distal end, defining a chamber, wherein the syringe barrel has an opening at the proximal end, A plunger assembly inserted into the opening and movable axially within the chamber of the syringe barrel, the plunger assembly comprising an elongated body and a plunger rod extending between a proximal and distal end, and a stopper attached to the distal end of the plunger rod and positioned within the chamber of the barrel, Syringe cap and Equipped with, The syringe cap is, An inner molded portion comprising a first end and a second end, defining an internal space, wherein the first end includes an open end and includes a female connector formed on the first end, and the second end includes a closed end, A radio frequency identification (RFID) element is positioned on the second end of the inner molded portion and extends around at least a portion of the second end; An outer molded portion, the outer molded portion is formed on the second end of the inner molded portion and on the RFID element, enclosing the RFID element between the inner molded portion and the outer molded portion, the outer molded portion has an outer surface including a plurality of spline teeth, the plurality of spline teeth are spaced apart in the circumferential direction and extend radially outward from the outer surface, and Equipped with, The aforementioned plurality of spline teeth have a height of 0.400 mm or more that extends radially outward from the outer surface. The female connector of the inner molded portion is connected to the male connector provided at the distal end of the syringe barrel. The RFID element includes a syringe with a flat RFID inlay that fits the cylindrical outer surface of the second end of the inner molded portion.

13. A method for forming a syringe cap that is integrally molded, wherein the method is A step of forming an inner cap portion having a first end and a second end and defining an internal space, wherein the first end has an open end and is provided with a female connector formed at the open end, and the second end has a closed end, A step of installing a radio frequency identification (RFID) element on the second end of the inner molded portion, wherein the RFID element is installed so as to extend along the periphery of at least a portion of the second end; A step of molding the outer cap portion on the second end of the inner molded portion and on the RFID element in order to enclose the RFID element between the inner cap portion and the outer cap portion, wherein the outer cap portion has an outer surface, the outer surface has a plurality of spline teeth that are spaced apart in the circumferential direction and extend radially outward from the outer surface. Equipped with, The plurality of spline teeth have a height of 0.400 mm or more that extends radially outward from the outer surface. The method is characterized in that the RFID element comprises a flat RFID inlay that fits along the cylindrical outer surface of the second end of the inner molded portion.

14. The method according to 13, characterized in that, in the step of forming the outer cap portion, each of the plurality of spline teeth extends from the outer surface in a range of 0.400 mm to 0.750 mm.

15. The method according to claim 13 or 14, characterized in that, in the step of forming the inner cap portion, the second end of the inner molded portion has a circumferential outer surface, and the outer diameter of the second end is approximately 9.75 mm.

16. The method according to any one of claims 13 to 15, wherein the step of forming the inner cap portion includes forming ribs on the cylindrical outer surface of the inner cap portion, and the ribs extend radially outward from the cylindrical outer surface.

17. The method according to 16, wherein the step of forming the outer molded portion comprises forming the outer molded portion on the inner molded portion including the ribs, and the ribs form an interference between the inner molded portion and the outer molded portion.

18. The method according to 16, wherein the step of forming the outer molded portion comprises forming the outer molded portion on the inner molded portion except for the ribs, the ribs are not covered by the outer molded portion, and the radially outward-facing surface of the ribs is flush with the outer surface of the outer molded portion, or extends radially outward beyond the outer surface of the outer molded portion to a height equal to the height of the plurality of spline teeth.

19. The method according to any one of claims 16 to 18, wherein the step of installing the RFID element on the inner molded portion includes installing the RFID element on the cylindrical outer surface of the second end so as not to overlap with the rib, the rib is provided with an angle locator, and the RFID element is positioned relative to the angle locator.

20. A syringe cap for use with syringes, The syringe cap is, An inner molded portion comprising a first end and a second end, defining an internal space, wherein the first end includes an open end and includes a female connector formed thereon, and the second end includes a closed end, A radio frequency identification (RFID) element is positioned on the second end of the inner molded portion and extends around at least a portion of the second end; An outer molded portion, the outer molded portion is formed on the second end of the inner molded portion and on the RFID element, enclosing the RFID element between the inner molded portion and the outer molded portion, the outer molded portion has an outer surface including a plurality of spline teeth, the plurality of spline teeth are spaced apart in the circumferential direction and extend radially outward from the outer surface, and Equipped with, The second end of the inner molded portion is provided with a rib formed on its cylindrical outer surface, the rib extending radially outward from the cylindrical outer surface, and forming interference between the inner molded portion and the outer molded portion. The syringe cap is characterized in that the RFID element comprises a flat RFID inlay that fits the cylindrical outer surface of the second end of the inner molded portion.

21. The syringe cap according to claim 20, characterized in that the rib includes an angle locator, the RFID element is positioned relative to the angle locator, and the RFID element is positioned on the cylindrical outer surface of the second end such that it does not overlap with the rib.

22. The syringe cap according to claim 20 or 21, characterized in that the outer molded portion is formed on the inner molded portion including the ribs.

23. The syringe cap according to claim 20 or 21, characterized in that the outer molded portion is formed on the inner molded portion except for the ribs, the ribs are not covered by the outer molded portion, and the radially outward-facing surface of the ribs is flush with the outer surface of the outer molded portion.

24. The syringe cap according to claim 20 or 21, characterized in that the outer molded portion is formed on the inner molded portion except for the ribs, the ribs are not covered by the outer molded portion, and a portion of the ribs extends radially outward beyond the outer surface of the outer molded portion to a height equal to the height of the plurality of spline teeth.

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