Systems and methods for single reading of medical devices with RFID tags

Abstract

A system and method for performing a singulated read on each of a plurality of RFID tagged medical devices is provided herein. A transfer system (72) transfers a plurality of RFID-tagged medical devices (10) along a transfer path, wherein each of the RFID-tagged medical devices includes an RFID tag (62) integrated therewith. An RFID reading system (76) is disposed at a location along the transfer path, where the RFID reading system comprises: an RFID coupling element (80) positioned at a reading location along the transfer path, the RFID coupling element comprising a dipole coupling element; and an RFID reader (78) operably connected with the RFID coupling element. The RFID reading system performs a singulation reading on each of the respective RFID-tagged medical devices as the RFID-tagged medical devices pass through the reading location, and retrieves a unique identifier (UID) for each of the RFID-tagged medical devices based on the singulation reading of the RFID-tagged medical devices.

Description

Cross-reference to related applications

[0001] This application claims priority to U.S. Provisional Application No. 63 / 583,667, filed on September 19, 2023, entitled “System and Method for Singulated Reading of RFID-Tagged Medical Devices,” the disclosure of which is hereby incorporated by reference in its entirety.

[0002] Background of the Invention Field of the Invention This disclosure relates generally to medical devices, and more particularly to systems and methods for the individual reading of RFID-tagged medical devices during the manufacture of such devices.

[0003] Description of related technologies In the design, manufacture, assembly, and use of medical devices, there is a growing need for individual traceability of such devices from the manufacturing process to their final labeling, use, or disposal. For example, traceability and connectivity of injection devices, as well as data logging and retrieval, are becoming standard practice for injection devices such as syringes or autoinjectors.

[0004] Previous attempts to address this need for traceability during manufacturing and / or along the supply chain have involved implementing RFID tags (including RFID chips and RFID antennas) on medical devices for remote identification. However, existing solutions for quality control processing of RFID-tagged products during manufacturing have shortcomings that can affect the ability to provide reliable manufacturing standards for RFID-tagged products. For example, most off-the-shelf RFID reader and antenna solutions support bulk reading of inventory (i.e., reading several RFID-tagged items simultaneously), but this bulk reading is unsuitable when it is desirable to perform a single read of each of multiple RFID-tagged products (as is often desired when quality control processing of RFID-tagged products is performed during manufacturing). While near-field antennas coupled to RFID readers can be used for the single-reading of products with RFID tags, the characteristics of these RFID near-field antennas (due to their beam patterns, coupling types, etc.) may not meet the manufacturing requirements of medical devices (such as RFID-tagged injection devices), including requirements regarding the spacing (e.g., 60 mm, 30 mm, or less) and transport speed (e.g., >1 m / s) of these RFID-tagged injection devices when processing multiple RFID-tagged injection devices along a transport system or system. Therefore, attempts to read multiple RFID-tagged injection devices in a single-reading manner using existing RFID reading systems during manufacturing often result in cross-reading defects, where a cross-reading defect refers to a situation where multiple RFID-tagged injection devices are not read in the correct transport sequence (i.e., a second position device is read before a first position device).

[0005] Therefore, there is a need in the art for a system and method that addresses the aforementioned drawbacks by providing an effective and reliable means for the individual reading of multiple RFID-tagged medical devices during the manufacture of such devices, wherein the system and method are capable of providing accurate individual reading of such devices based on the required spacing and transmission speed associated with the manufacturing environment. Summary of the Invention

[0006] This document provides a method for reading each of a plurality of RFID-tagged medical devices. The method includes: conveying each of the plurality of RFID-tagged medical devices along a conveying path via a conveying system, each of the plurality of RFID-tagged medical devices including an integrated RFID tag. The method further includes: providing an RFID reading system at a location along the conveying path, the RFID reading system including: an RFID coupling element positioned at the reading location along the conveying path, the RFID coupling element including a dipole coupling element; and an RFID reader operatively connected to the RFID coupling element. The method further includes: performing a unique read on each of the respective RFID-tagged medical devices via the RFID reading system as the plurality of RFID-tagged medical devices pass the reading location; and retrieving a unique identifier (UID) for each of the plurality of RFID-tagged medical devices based on the unique read of the plurality of RFID-tagged medical devices.

[0007] In some configurations, when retrieving the UID of each of the plurality of medical devices with RFID tags, the method further includes operating the RFID reader to: determine whether the RFID tag of the corresponding medical device with RFID tags has been successfully read; if the RFID tag has not been successfully read, generate a failure signal for the medical device with the corresponding RFID tag; and transmit the failure signal to a controller operatively connected to the RFID reader.

[0008] In some configurations, when transmitting the failure signal to the controller, the RFID reader transmits the failure signal to the computer responsible for communicating with the controller, and then the computer sends the failure signal to the controller.

[0009] In some configurations, the method further includes: receiving the failure signal at the controller; and outputting a command from the controller to cause the delivery system to remove the failed RFID-tagged medical device from the delivery path.

[0010] In some configurations, these RFID-tagged medical devices include one of a syringe, an auto-injector, or a safety device.

[0011] In some configurations, these RFID-tagged medical devices include syringes, wherein the RFID tag for each syringe is embedded in or applied to one of the syringe's end cap, barrel, flange, or plunger rod.

[0012] In some configurations, the curvature of the RFID tag matches the curvature of the syringe tip cap or barrel.

[0013] In some configurations, when performing a single read on the corresponding RFID-tagged medical device, the RFID reader performs the read on the RFID-tagged medical device over a period of 6 ms or longer.

[0014] In some configurations, the method further includes positioning the RFID coupling element relative to the RFID tag in each of the plurality of medical devices with RFID tags, such that the polarization axis or dipole axis of the RFID coupling element is substantially parallel to the polarization axis or dipole axis of the RFID tag.

[0015] In some configurations, the parallelism between the polarization axis or dipole axis of the RFID coupling element and the polarization axis or dipole axis of the RFID tag is within + / -30 degrees.

[0016] In some configurations, when the plurality of RFID-tagged medical devices are transported, the spacing between the center lines of the RFID tags of adjacent RFID-tagged medical devices being transported is 19 mm or greater, and wherein, through the RFID coupling element and the RFID reader, the individual reading of each of the plurality of RFID-tagged medical devices prevents cross-reading of one RFID-tagged medical device with other adjacent RFID-tagged medical devices.

[0017] In some configurations, when transporting the multiple medical devices with RFID tags, the spacing between adjacent medical devices with RFID tags is 3 mm or greater.

[0018] In some configurations, the method further includes positioning the RFID coupling element such that it is 1 mm to 50 mm away from the RFID-tagged medical device when the corresponding medical device with the RFID tag is located at the reading position.

[0019] In some configurations, the method further includes setting the output power from the RFID reader to the RFID coupling element based on the separation distance between the RFID coupling element and the medical device with the RFID tag.

[0020] In some configurations, the method further includes positioning the RFID coupling element at the reading position such that when the corresponding medical device with an RFID tag is located at the reading position, the dipole coupling element of the RFID coupling element is vertically centered relative to the RFID tag in the medical device with an RFID tag.

[0021] In some configurations, the transport path includes a linear transport path or a circular transport path, and wherein the transport system transports the multiple RFID-tagged medical devices along the transport path at a transport speed and at intervals that allow for a single read of up to 6,000 parts per minute (part / min).

[0022] In some configurations, when performing a single read on each of the plurality of RFID-tagged medical devices, the method further includes operating the RFID reader to: receive a trigger input signal from a controller or sensor associated with the RFID reader; electromagnetically couple the RFID coupling element to the corresponding RFID-tagged medical device in response to receiving the trigger signal; and perform a single read on the RFID-tagged medical device once the RFID coupling element is electromagnetically coupled to the corresponding RFID-tagged medical device.

[0023] In some configurations, the method further includes: sensing via the sensor when a corresponding RFID-tagged medical device is located at the reading position, where the RFID-tagged medical device passes in front of and near the RFID coupling element; and generating the trigger signal from the controller once the RFID-tagged medical device is sensed to be located at the reading position.

[0024] This document also provides an RFID reading system for performing a single read of each of a plurality of RFID-tagged medical devices being transported along a transport path at a transport speed by a transport system, wherein each of the plurality of RFID-tagged medical devices includes an integrated RFID tag. The RFID reading system includes: an RFID coupling element positioned at a read position along the transport path, the RFID coupling element including a dipole coupling element; and an RFID reader operatively connected to the RFID coupling element to selectively provide reads of the RFID tags of each of the plurality of RFID-tagged medical devices. The RFID reader is configured to: perform a single read of the RFID tag of the corresponding RFID-tagged medical device as soon as it passes in front of and near the RFID coupling element at the read position; and output a pass / fail signal to the RFID-tagged medical device based on a read or read failure of the RFID tag of the RFID-tagged medical device.

[0025] In some configurations, the polarization axis or dipole axis of the RFID coupling element is substantially parallel to the polarization axis or dipole axis of the RFID tag in each of the plurality of medical devices with RFID tags.

[0026] In some configurations, these RFID-tagged medical devices include one of a syringe, an auto-injector, or a safety device.

[0027] In some configurations, these RFID-tagged medical devices include syringes, wherein the RFID tag for each syringe is embedded in or applied to one of the syringe's end cap, barrel, flange, or plunger rod.

[0028] In some configurations, when outputting the pass / fail signal for each of the plurality of RFID-tagged medical devices, the RFID reader is also configured to: determine whether the RFID tag of the corresponding RFID-tagged medical device has been successfully read; and if the RFID tag has not been successfully read, generate a failure signal for the corresponding RFID-tagged medical device.

[0029] In some configurations, the RFID reading system also includes a programmable logic controller configured to: receive a pass / fail signal for each corresponding medical device with an RFID tag; and, when the pass / fail signal for the corresponding medical device with an RFID tag is a failure signal, cause the conveying system to remove the failed medical device with an RFID tag from the transport path.

[0030] In some configurations, the RFID reading system is configured to: receive a trigger input signal from the controller or sensor associated with the RFID reader, the trigger input signal indicating that a corresponding medical device with an RFID tag is passing in front of and near the RFID coupling element at the reading location; in response to receiving the trigger signal, electromagnetically couple the RFID coupling element to the RFID tag of the corresponding medical device with an RFID tag; and once the RFID coupling element is electromagnetically coupled to the corresponding medical device with an RFID tag, perform a single reading of the medical device with an RFID tag. Attached Figure Description

[0031] Figure 1 This is a perspective view of a syringe with an RFID tag, and embodiments of this disclosure can be implemented using this syringe with an RFID tag. Figure 2 for Figure 1 An exploded view of the syringe; Figure 3 To include, according to the non-limiting embodiments described herein, Figure 1 A side view of the end cap in the syringe, showing the orientation of the RFID tag attached to the end cap; Figure 4 A manufacturing environment according to a non-limiting embodiment described herein, for manufacturing and reading multiple syringes (e.g. Figure 1 The method (using a syringe) can be performed in this manufacturing environment; Figure 5 This is based on the non-limiting embodiments described herein. Figure 4 A schematic block diagram of the conveying system and RFID reading system included in the manufacturing environment; Figure 6 For use according to the non-limiting embodiments described herein Figure 5 A three-dimensional diagram of the RFID coupling element of an RFID reading system; Figure 7 for Figure 6 Detailed perspective view of the housing of the RFID coupling element; Figure 8A for Figure 6 Front view of the housing of the RFID coupling element; Figure 8B for Figure 6 Front view of the housing of the RFID coupling element; Figure 8C for Figure 6 Side view of the housing of the RFID coupling element; Figure 8D for Figure 6 Rear view of the housing of the RFID coupling element; Figure 9 Positioning of a syringe with an RFID tag relative to a transport along a conveying system, according to a non-limiting embodiment described herein. Figure 6 A front-view perspective view of the RFID coupling element; and Figure 10 For positioning of a syringe with an RFID tag relative to a conveying system according to a non-limiting embodiment described herein. Figure 6 A side-view perspective of the RFID coupling element; Figure 11 This is an illustration of a non-limiting embodiment described herein. Figure 5 A schematic block diagram illustrating the RFID reading system performing a single reading of a syringe with an RFID tag; and Figure 12This is a schematic block diagram illustrating the alignment of an RFID coupling element and an RFID tag incorporated in a syringe with an RFID tag, according to a non-limiting embodiment described herein. Detailed Implementation

[0032] The following description is provided to enable those skilled in the art to make and use the described embodiments for carrying out the invention. However, various modifications, equivalents, variations, and substitutions will still be apparent to those skilled in the art. Any and all such modifications, variations, equivalents, and substitutions are intended to fall within the spirit and scope of the invention.

[0033] In the following text, for descriptive purposes, the terms “upper,” “lower,” “right,” “left,” “vertical,” “horizontal,” “top,” “bottom,” “lateral,” “longitudinal,” and their derivatives shall be used in connection with the present invention as oriented as shown in the accompanying drawings. However, it should be understood that the invention may take various alternative variations unless explicitly stated to the contrary. It should also be understood that the specific devices shown in the drawings and described in the following specification are merely exemplary embodiments of the invention. Therefore, the specific dimensions and other physical characteristics associated with the embodiments disclosed herein should not be considered limiting.

[0034] In this disclosure, the distal end of a component or device refers to the end furthest from the user's hand when the component or device is in the use position, i.e., when the user holds the syringe in preparation for or during use. The proximal end of a component or device refers to the end closest to the user's hand when the component or device is in the use position, i.e., when the user holds the syringe in preparation for or during use. Similarly, in this application, the terms "in the distal direction" and "towards the distal end" refer to the direction toward the distal tip of the syringe, while the terms "in the proximal direction" and "towards the proximal end" refer to the direction opposite to the direction of the distal tip of the syringe.

[0035] Various aspects and embodiments of this disclosure relate to systems and methods for performing individual readings of multiple RFID-tagged medical devices during the manufacturing process for quality control.

[0036] refer to Figure 1 and Figure 2This illustration shows a non-limiting embodiment of a medical device with an RFID tag, and aspects or embodiments of this disclosure can be implemented using this RFID-tagged medical device. Although the medical device is shown and described below as a syringe (“syringe 10”), it should be recognized that other RFID-tagged medical devices, including other medical injection devices (e.g., auto-injectors) or safety devices, can be used in conjunction with the systems and methods of this disclosure described in detail below.

[0037] like Figure 1 and Figure 2 As shown, syringe 10 typically includes a syringe barrel 12 and a plunger assembly 14. For example, the plunger assembly 14 can be moved within syringe barrel 12 along a longitudinal axis to an advanced position to facilitate the administration of an injectable fluid (e.g., a drug) to a patient. Syringe barrel 12 is formed by a generally cylindrical outer wall 16 and an end member 18, which together define a chamber 20 for retaining fluid therein. Syringe barrel 12 includes an open proximal end 22 and a distal end 24, the open proximal end being configured to receive the plunger assembly 14 therein, with the end member 18 positioned at the distal end. The proximal end 22 of syringe barrel 12 may include a flange 26 to facilitate manipulation and positioning of syringe 10 and to maintain the relative position of syringe barrel 12 with respect to plunger assembly 14 during drug administration. At the distal end 24, end member 18 may include a shoulder 28 that narrows relative to the cylindrical outer wall 16, and a hub portion 30 extending distally from the shoulder 28. The hub portion 30 is formed as a partially hollow member that defines a channel 32 through which it passes and is in fluid communication with the chamber 20. In some embodiments, the needle 34 is attached to the hub portion 30 within the channel 32, for example by gluing or otherwise securing it to the hub portion 30. In other embodiments, it should be appreciated that the syringe 10 may alternatively include a Luer connector formed at the distal end 24 of the syringe barrel 12, instead of the needle 34, which allows the syringe 10 to be directly coupled to the Luer connector of an associated medical device or component to provide direct fluid transfer between them.

[0038] The plunger assembly 14 of the syringe 10 is formed by an elongated plunger rod 36 (more generally referred to below as "plunger 36") and a plunger head or stop 38. The plunger 36 may include a body 40 extending between a proximal plunger end 42 and a distal plunger end 44. In some embodiments, the body 40 may include a plurality of elongated blades or walls 46 extending along the length axis of the body between the proximal plunger end 42 and the distal plunger end 44. A thumb press 48 is positioned at the proximal plunger end 42, which can be engaged by a user's thumb (or other finger) to apply a distally directed force to the plunger assembly 14, thereby moving the plunger 36 relative to the syringe barrel 12. In some embodiments, a flanged extension 50 (e.g., a disc flange) is positioned at the distal plunger end 44, the flanged extension being configured to engage with the stop 38. In other embodiments, the distal end 44 of the plunger may include a female receiving portion formed therein, which is configured to receive and engage a protrusion (e.g., a pin) extending proximally from the stop, for example, the protrusion and the receiving portion being engaged by a threaded connection.

[0039] A stop 38 of the plunger assembly 14 is positioned at the distal end 44 of the plunger so as to move with the plunger 36 within the chamber 20 of the syringe barrel 12. The stop 38 may be made of a material different from that of the plunger 36 and capable of forming a tight seal with the syringe barrel 12 as the stop advances through it. In some embodiments, the stop 38 includes a receiving portion (not shown) formed therein, which is sized and configured to receive a flanged extension 50 of the plunger 36, wherein the flanged extension 50 is engaged with the receiving portion, for example, by a press-fit connection, to secure the stop 38 to the plunger 36. However, it is understood that the stop 38 and the distal end 44 of the plunger can be secured using other techniques known in the art.

[0040] like Figure 1 and Figure 2 As shown, and now as Figure 3 As shown, the syringe 10 also includes an end cap 60 that can be coupled to the hub portion 30 of the syringe barrel 12. Although in Figure 1 and Figure 2The diagram shows a needle shield for protecting the needle 34, but the end cap 60 may alternatively be configured as a cap covering the Luer connector. According to various aspects and embodiments of this disclosure, the end cap 60 may include an RFID tag 62 integrated therein, which allows identification and / or tracking of the syringe 10. That is, the RFID tag 62 may include or store information thereon about the contents of the syringe 10 (i.e., the medication or agent included, if it is a pre-filled syringe) and the manufacturing history of the syringe, and / or may provide location information to an associated reader to enable tracking of the syringe 10. Therefore, the RFID tag 62 is considered to typically include a unique identifier (UID) specific to the syringe 10. According to various aspects or embodiments of this disclosure, the RFID tag 62 may be integrated into the end cap 60, for example, by embedding or otherwise disposed between the inner and outer shells of the end cap. According to other embodiments, the RFID tag 62 may be applied to the outer surface of the end cap 60. According to other embodiments, it should be recognized that the RFID tag 62 may alternatively be applied to another component of the syringe 10, such as to the syringe barrel 12 (i.e., to the cylindrical outer wall 16 or flange 26 of the syringe barrel) or to the plunger rod 36, rather than integrated into / on the end cap 60. In each of these embodiments, the RFID tag 62 is abutted against one or more surfaces or walls such that, or within one or more surfaces or walls, the RFID tag 62 will have a curvature that matches the curvature of the end cap 60 or barrel 12 when integrated / integrated with a cylindrical component such as the end cap 60 or barrel 12.

[0041] According to various embodiments, and as Figure 3 As shown, the RFID tag 62 includes an RFID chip 64 connected to an RFID dipole coupling element 66. The RFID dipole coupling element 66 of the RFID tag 62 may include two legs or dipole elements D1, D2, wherein the RFID chip 64 is disposed between the ends of each pole D1, D2, for example, centered between the ends of each pole. In some embodiments, the RFID tag 62 may be positioned and oriented within an end cap 60 such that the dipole axis A of the RFID tag 62... D With the longitudinal axis A of the end cap 60 C (and the longitudinal axis A of syringe 10) SThe approximate alignment allows for more stringent quality control during the manufacture / assembly of the syringe 10 and its cap 60, as explained in further detail below. In other embodiments, the RFID tag 62 may be positioned and oriented within the end cap 60 such that the dipole axis A of the RFID tag 62 is... D Relative to the longitudinal axis A of the end cap 60 C Oriented at a specific angle, for example, as a non-limiting example, along the longitudinal axis A of the end cap 60. C within + / - 20 degrees.

[0042] According to various aspects of this disclosure, a system and method are provided for testing or querying (hereinafter referred to as "reading") a medical device with an RFID tag. In some embodiments, such as Figures 1 to 3 As shown and described, the medical device with RFID tag can be provided as syringe 10, but it should be recognized that these devices can alternatively be other medical injection devices (e.g., auto-injectors) or other medical devices (e.g., safety devices) with RFID tags integrated thereon or therein.

[0043] Now for reference Figure 4 According to one aspect of this disclosure, a manufacturing and reading environment in which a medical device 10 with an RFID tag (hereinafter referred to as "injector 10 with an RFID tag") can be read is shown. According to some aspects of this disclosure, reading of the injector 10 with the RFID tag can be implemented as part of a quality control process for the injector. However, it should be recognized that reading of the injector 10 with the RFID tag can be implemented for other processes associated with the manufacture and / or subsequent tracking of the injector.

[0044] like Figure 4 As shown, the provided system 70 includes a conveying system 72 on which a plurality of RFID-tagged syringes 10 can be dynamically conveyed / translated as part of an assembly and quality control process. According to various embodiments, the RFID-tagged syringes 10 can be conveyed by the conveying system 72 along a linear or circular path. Each of these RFID-tagged syringes 10 can be held by a holding or clamping device 74 of the conveying system 72, wherein the RFID-tagged syringes 10 are held in place by mechanical force, suction, or other suitable means. As the RFID-tagged syringes 10 advance along the conveying system 72, they pass through an RFID reading system 76 of the system 70, a portion of which... Figure 4As shown below, the RFID reading system 76 is configured to read or query the RFID tag 62 in each of the RFID-tagged syringes 10 in a unified manner to determine the appropriate operability of each tag as part of a quality control process. According to various embodiments of this disclosure, the conveying system 72 can be operated / constructed as a “high-throughput” conveyor line that conveys the RFID-tagged syringes 10 along a conveying path at a high rate and with close spacing between them to achieve a reading rate for the RFID-tagged syringes 10. As a non-limiting example, the RFID reading system 76 and the conveying system 72 can work together to achieve a reading rate of 100 parts / second or 6000 parts / minute, wherein such a reading rate can be achieved with the conveying system 72 advancing the RFID-tagged syringes 10 at a speed of approximately 1 m / s and a spacing of approximately 19 mm.

[0045] According to one embodiment of this disclosure, Figure 5The schematic diagram shows the components of the RFID reading system 76 in more detail. The RFID reading system 76 may include an RFID reader 78 and an accompanying RFID coupling element 80 (with a dipole coupling element 96), which is capable of reading the RFID tags 62 of each syringe 10 carrying an RFID tag, transported along the delivery system 72. A control system 82 may also be provided with the RFID reading system 76 (as part of the RFID reading system 76, or separately but operationally associated with the RFID reading system 76), through which the operation of the RFID reader 78 may be selectively controlled (and optionally, the operation of the delivery system 72 may be controlled), and / or through which the reading results obtained by the RFID reader 78 may be processed and analyzed. In the non-limiting embodiment shown, the control system 82 includes a programmable logic controller (PLC) 84, a server / database and associated application programming interface (API) 86, an optional supervisory control and data acquisition (SCADA) system 88, and a sensor / sensing system 90, wherein these control system components collectively enable the operation of the delivery system 72 and control various aspects of the RFID reading system 76 to enable the reading of the RFID tag of the syringe 10 and the retrieval of the UID therefrom, which may be desired, for example, for quality control and / or other manufacturing-related controls or parameters.

[0046] The RFID reader 78 can be of a known architecture, enabling the reading of the RFID tag 62 in the syringe 10 to retrieve the UID of that RFID tag. Therefore, although in Figure 5 Not shown, but it should be understood that, as a non-limiting example, the RFID reader 78 may include some or all of the following circuits, modules, or controllers: a clocking device for transmitting a clock signal used to time the modulation and demodulation operations of transmitted and received electromagnetic signals; a modulation circuit for generating appropriate modulation of the electromagnetic field; an amplification and control circuit for driving the RFID coupling element 80; a demodulation circuit for demodulating the modulation response transmitted by the RFID tag 62 and picked up by the RFID coupling element 80; an amplification and filtering circuit for the signal generated at the output of the demodulation circuit; and / or a decoding circuit for the demodulated, amplified, and filtered signal.

[0047] Command signals for controlling the operation of RFID reader 78 can be provided by PLC 84, wherein PLC 84 and RFID reader 78 operatively communicate with each other. In some embodiments, PLC 84 and RFID reader 78 can communicate directly with each other, for example, directly along an input / output cable or communication line. In other embodiments, PLC 84 and RFID reader 78 can communicate indirectly with each other via a communication network, for example, via a computer controlling the operation of PLC 84 via a network connection (e.g., the RFID reader can transmit signals to a computer responsible for communicating with the controller).

[0048] According to various aspects of this disclosure, PLC 84 can provide a trigger signal to RFID reader 78 to control the operation of the RFID reader in reading RFID tags 62 integrated in syringes 10 with RFID tags. According to various embodiments, the transmission of the trigger signal to RFID reader 78 can be determined based on the positioning of the syringe 10 with RFID tags relative to the RFID coupling element 80; however, it should be appreciated that in other embodiments, a continuous reading scheme can be employed to operate the RFID reader 78. As an example, PLC 84 can determine when to transmit the trigger signal to RFID reader 78 based on signals received by PLC 84 from one or more sensors 90 that identify / detect the positioning of the syringe 10 with RFID tags on the delivery system 72 relative to the RFID coupling element 80, wherein this positional information determines the appropriate time to trigger RFID reader 78 and RFID coupling element 80 to enable individual reading of each syringe 10 with RFID tags. In other embodiments, one or more sensors 90 may be directly connected to the RFID reader 78, wherein the one or more sensors 90 transmit trigger signals directly to the RFID reader 78 to trigger the RFID reader 78 and the RFID coupling element 80, thereby enabling individual reading of each syringe 10 with an RFID tag, thus eliminating the need for the PLC 84 in the triggering process.

[0049] According to various aspects of this disclosure, PLC 84 can communicate bidirectionally with RFID reader 78 via an input / output cable or communication line, wherein PLC 84 receives output signals from RFID reader 78. As explained in further detail below, PLC 84 can receive output signals from RFID reader 78 regarding whether a reading of syringe 10 with RFID tag was successfully performed (i.e., "pass / fail" signals).

[0050] Furthermore, according to various aspects of this disclosure, the PLC 84 can operatively communicate with the conveyor system 72. In some embodiments, the operation of the conveyor system 72 can be controlled by the PLC 84, including controlling the conveying speed and starting / stopping the conveyor system 72. The PLC 84 can also control the operation of the conveyor system 72 in conjunction with performing quality control of the syringes 10 with RFID tags. That is, as explained in further detail below, the PLC 84 can control the conveyor system 72 (i.e., the clamping device 74) to selectively eject defective syringes 10 with RFID tags from the conveyor system, which can be determined by the RFID reading system 76 through a single reading of each of these syringes 10 with RFID tags.

[0051] As described above, the control system 82 may optionally include a server / database 86 that operatively communicates with the RFID reader 78 to receive output from the RFID reader. According to various aspects of this disclosure, the server / database 86 may receive read data from the RFID reader 78, generated by reading the syringe 10 with an RFID tag, i.e., the UID of the syringe 10 with the RFID tag. The server / database 86 may include a memory module that stores the UID data of the syringe 10 with the RFID tag.

[0052] According to various aspects of this disclosure, the RFID coupling element 80 included in the RFID reading system 76 is specifically configured to enable a single reading of the RFID-tagged syringes 10 to retrieve their UIDs as they move along the conveyor system 72 during their manufacture. As described above, the conveyor system 72 can operate as a high-throughput conveyor line that transports the RFID-tagged syringes 10 along the conveyor path at a speed and at intervals that enable a single reading of up to 6000 syringes / minute, wherein the RFID coupling element 80 is accordingly configured to enable such a single reading of the RFID-tagged syringes 10 as they move along the conveyor system 72, while minimizing / eliminating the possibility of cross-reading defects during the reading of the RFID-tagged syringes 10.

[0053] Now for reference Figures 6 to 10 And continue to refer to Figures 1 to 5The RFID coupling element 80 is shown as typically comprising a housing 92, a mounting element 94, and a dipole coupling element 96. The housing 92 may be a generally rectangular structure defining an internal volume, having a front surface 98 and a rear surface 100. The housing 92 may be sized to allow the RFID coupling element 80 to be positioned close to the delivery system 72 and the syringe 10 with an RFID tag being transported along the delivery system. In some embodiments, the housing 92 may have dimensions of 77 mm wide × 50 mm high × 21 mm deep to position the RFID coupling element 80 in a narrow / confined space near the delivery system 72. A coaxial connector 102 may be provided on the rear surface 100 of the housing 92, to which an RF cable 104 can be connected, operatively connecting an RFID reader 78 to the RFID coupling element 80. In some embodiments, the RF cable 104 may be of sufficient length to position the RFID coupling element 80 near the delivery system 72, while the RFID reader 78 is positioned at a more distant location where space constraints are not an issue. Therefore, in some embodiments, as a non-limiting example, the RF cable 104 may have a length of 1.5 meters to 2 meters.

[0054] According to various aspects of this disclosure, the housing 92 can be formed of a cleanroom-compatible material, which may be necessary for manufacturing the syringe 10 with an RFID tag. Therefore, as a non-limiting example, the housing 92 can be formed of stainless steel, polyether-ether-ketone (PEEK), or aluminum. Furthermore, at least a portion of the housing 92 can be formed of a non-metallic material that does not affect the RF characteristics of the RFID coupling element 80, i.e., the RF characteristics of the RF signal transmission / reception of the dipole coupling element 96 during the reading of the RFID tag 62. For example, at least a portion (denoted as 105) of the front surface 98 of the housing 92 adjacent to or immediately adjacent to the dipole coupling element 96 is formed of a non-metallic material, such as a suitable polymeric material. The dimensions of the housing portion 105 formed of such a material can vary based on the configuration of the ends of the dipole coupling element 96; however, as a non-limiting example, the housing portion 105 can be a 20 mm × 20 mm square portion. In other embodiments, the entire front surface 98 may be configured as a cover made of a non-metallic material that does not affect the RF characteristics of the RFID coupling element 80.

[0055] According to some aspects of this disclosure, a plurality of mounting features 106 may be provided on the housing 92, for example, a plurality of mounting features may be provided at each of the opposite ends of the housing 92, wherein these mounting features 106 are used for securing the housing 92 to the mounting member 94 and / or adjusting the housing on the mounting member. According to some embodiments, the mounting features 106 may include an arrangement of openings or holes that can be aligned with corresponding openings or holes on the mounting member 94, such that fasteners can be inserted into these openings or holes to secure the housing 92 to the mounting member 94.

[0056] According to some aspects of this disclosure, the engagement between the mounting member 94 and / or the mounting member 94 and the housing 92 (via mounting feature 106) can provide three-dimensional positional adjustment of the RFID coupling element 80. That is, the positional adjustment of the RFID coupling element 80 can be achieved in the following ways: (at the reading position 108, where the syringe 10 with the RFID tag is read by the RFID reading system 76) in the x-axis parallel to the direction of travel of the delivery path of the syringe 10 with the RFID tag; in the z-axis away from and towards the corresponding syringe 10 with the RFID tag when at the reading position 108; and in the y-axis perpendicularly upward and downward relative to the corresponding syringe 10 with the RFID tag when at the reading position 108, thereby enabling the RFID coupling element 80 to be vertically centered relative to the RFID tag 62 in the corresponding syringe 10 with the RFID tag, such as... Figures 9 to 12 As best shown in the diagram. According to various embodiments of this disclosure, the three-dimensional position adjustment of the RFID coupling element 80 can be achieved by manual adjustment of the mounting member 94 and / or between the mounting member 94 and the housing 92 (e.g., by adjusting the fasteners), or by electronically controlled adjustment of the mounting member 94 and / or between the mounting member 94 and the housing 92 (e.g., by a servo motor mounted on the mounting member 94). As a non-limiting example, position adjustment of 1 mm to 50 mm (in increments of 0.1 mm) can be provided in the z-axis, and position adjustment of 2 mm (in increments of 0.1 mm or less) can be provided in the y-axis.

[0057] According to some embodiments of this disclosure, the three-dimensional position adjustment of the RFID coupling element 80 can be achieved by manually adjusting the mounting member 94 and / or between the mounting member 94 and the housing 92. As an example, an opening or hole forming a mounting feature 106 on the housing 92 can be realigned with a corresponding opening or hole on the mounting member 94, and then fasteners subsequently secure the housing 92 and the mounting member 94 to adjust the positioning of the housing 92 (and the dipole coupling element 96 therein) in at least one dimension. As another example, an actuator or adjustment feature (e.g., a rotator, telescopic rod, etc.) on the mounting member 94 can be manually actuated by an operator to adjust the positioning of the housing 92 (and the dipole coupling element 96 therein) in at least one dimension. According to other embodiments of this disclosure, the three-dimensional position adjustment of the RFID coupling element 80 can be achieved by electronically controlled adjustment of the mounting member 94 and / or between the mounting member 94 and the housing 92. As an example, a servo motor on the mounting member 94 can be selectively operated to adjust the positioning of the housing 92 (and the dipole coupling element 96 therein) in at least one dimension.

[0058] like Figures 8A to 8D As best shown, the dipole coupling element 96 of the RFID coupling element 80 is at least partially contained within the housing 92 and may be formed by a pair of fine wires 110 (e.g., 1.6 mm in diameter). The dipole coupling element 96 includes ends 112 that provide a first dipole element D3 and a second dipole element D4. As a non-limiting example, each of these ends 112 may be arranged parallel to the front surface 98 of the housing 92 and may extend slightly outward (in the z-axis) from the front surface 98 of the housing 92 by a corresponding slot formed in the front surface 98 of the housing 92 to be exposed from the housing 92. In some embodiments, the ends 112 of the dipole coupling element 96 are configured as chamfered ends that present a smooth, outward-facing surface on the dipole coupling element 96. Therefore, when the syringe with the RFID tag (i.e., its end cap 60) comes into contact with the end 112 as it moves along the delivery system 72 and passes through the reading position 108, the chamfered end 112 can prevent the generation of particles during RFID reading.

[0059] Based on all aspects of this disclosure, and as follows Figure 9 As shown in the optimal configuration, the dipole coupling element 96 of the RFID coupling element 80 is configured such that the end 112 of the dipole coupling element is coupled to the dipole element of the RFID tag 62 integrated in the syringe 10 with the RFID tag. Figure 3Alignment of the ends 112 of the dipole coupling element 96 (D1, D2) is possible. The alignment of the ends 112 of the dipole coupling element 96 can be spatial (in the y-axis) or angular. According to one aspect of this disclosure, the ends 112 of the dipole coupling element 96 can be spaced apart (in the y-axis) to optimally align with the dipoles of the RFID tag 62 in the syringe 10 with the RFID tag. Thus, as a non-limiting example, the ends 112 of the dipole coupling element 96 can be spaced apart by 10 mm, but it should be understood that the exact spacing will depend on the design / configuration of the RFID tag 62. According to another aspect of this disclosure, the polarization axis or dipole axis of the dipole coupling element 96 is angularly aligned with the polarization axis or dipole axis of the RFID tag 62. In some embodiments, the polarization axis or dipole axis of the dipole coupling element 96 is aligned to be parallel to the polarization axis or dipole axis of the RFID tag 62. In other embodiments, the polarization axis or dipole axis of the dipole coupling element 96 is aligned so as to be considered "substantially parallel" to the polarization axis or dipole axis of the RFID tag 62, wherein the parallelism between the polarization axis or dipole axis of the dipole coupling element 96 and the polarization axis or dipole axis of the RFID tag 62 is within + / -30 degrees.

[0060] With the end 112 of the dipole coupling element 96 aligned with the RFID tag 62 as described above, the dipole coupling element 96 can effectively focus the electromagnetic field toward the RFID tag 62 of the RFID-tagged syringe 10 passing through the dipole coupling element (i.e., via read position 108). By employing the RFID coupling element 80 with the near-field electromagnetic dipole coupling element 96 (which can better focus the electromagnetic field onto a single RFID-tagged syringe 10 (and the RFID tag 62 therein)), each individual RFID-tagged syringe 10 can be dynamically read by the RFID reading system 76 without the potential for cross-reading defects, where a cross-reading defect refers to a situation where multiple RFID-tagged syringes 10 are not read in the correct delivery sequence (i.e., the second position syringe is read before the first position syringe).

[0061] According to various aspects of this disclosure, the end 112 of the dipole coupling element 96 has a length such that it enables a single reading of each corresponding RFID-tagged syringe 10 as it passes the RFID coupling element 80, i.e., at the "reading position 108" (where the RFID-tagged syringe 10 passes near and in front of the RFID coupling element 80). In other words, when the RFID-tagged syringes 10 pass the RFID coupling element 80 at a high transport speed (e.g., about 1 m / s), and when the RFID-tagged syringes 10 on the transport system 72 are closely spaced (e.g., about 19 mm), the dipole coupling element 96 and the RFID reader 78 must be configured to adequately read the RFID tags 62 of the syringes 10, while such reading should not be affected by cross-reading defects. According to various embodiments, the length of the end portion 112 of the dipole coupling element 96 can be between 1 mm and 100 mm, preferably between 10 mm and 20 mm, wherein this length of the end portion 112 is determined to enable the reading of the RFID-tagged syringe 10 as it passes the reading position 108 along the transport path. That is, the RFID-tagged syringe 10 should be "close enough for a sufficiently long time" to the dipole coupling element 96 of the RFID coupling element 80 to enable the reading of the RFID-tagged syringe 10, wherein the aforementioned length of the end portion 112 of the dipole coupling element 96 (parallel to the travel path of the RFID-tagged syringe 10 in the x-dimension as the RFID-tagged syringe passes the dipole coupling element 96) is long enough to provide this reading without being too long to cause potential cross-reading defects. In some embodiments, for a “sufficiently long and sufficiently close” read of an RFID-tagged syringe 10, the following parameters should be met: (1) when each RFID-tagged syringe 10 passes the read position 108, the positioning of the RFID tag 62 of each RFID-tagged syringe 10 relative to the dipole coupling element 96 should be such that the interval between the RFID coupling element 80 and the RFID-tagged syringe 10 in the z-dimensional should be controlled between 1 mm and 50 mm, and (2) the RFID tag 62 of each RFID-tagged syringe 10 should pass the read position 108 (i.e., aligned with the dipole coupling element 96 in the x-dimensional) within a minimum read time period of approximately 6 ms, wherein it should be recognized that the width of the end 112 and the speed of the delivery system 72 affect the read time period.

[0062] In addition to the description of the transmission system 72 and the RFID reading system 76 presented above, the following is a description of the operation method of the transmission system 72 and the RFID reading system 76, by which a UID can be retrieved from each of a plurality of medical devices with RFID tags.

[0063] This method begins with the manufacture or otherwise provision of multiple RFID-tagged medical devices 10, each containing an RFID tag 62. The RFID tag 62 may include information identifying the medical device (e.g., syringe size / volume, drug information, manufacturing date, etc.) and provide traceability / trackability of the RFID-tagged medical device 10 from the manufacturing process to its final labeling, final use, or disposal. As described above, by non-limiting example, the RFID-tagged medical device 10 can be any of a variety of different medical devices, including medical injection devices (e.g., (pre-filled) syringes or auto-injectors) or safety devices. In other embodiments, the RFID-tagged medical device 10 may be a specific component of such a medical injection device or safety device that has not yet been fully assembled with other components.

[0064] The RFID-tagged medical device 10 includes an RFID tag 62, which is contained within the device, for example, embedded within it or applied to its outer surface. For example, in the case where the RFID-tagged medical device 10 includes an RFID-tagged syringe (hereinafter referred to as "RFID-tagged syringe 10"), the RFID tag 62 can be integrated into the syringe tip cap 60 or applied to another component of the syringe 10, such as the syringe barrel 12 (i.e., the cylindrical outer wall 16 or flange 26 of the syringe barrel) or the plunger rod 36. In each of these embodiments, the RFID tag 62 is abutted against one or more surfaces or walls such that when integrated / integrated with a cylindrical component such as the tip cap 60 or the barrel 12, the RFID tag 62 will have a curvature matching the curvature of the tip cap 60 or the barrel 12. It should be recognized that this curvature of the RFID tag 62 in / on the syringe 10 with the RFID tag can make reading the RFID tag 62 (as part of quality control analysis) more challenging.

[0065] The syringe 10 with an RFID tag can be conveyed along the conveying system 72 as part of the manufacturing process. For example, in the case of pre-filled syringes, filling the syringe 10 with a drug and / or plugging the syringe 10 with an RFID tag can occur as the syringe 10 with an RFID tag is conveyed by the conveying system 72, which translates the syringe 10 with an RFID tag along a predefined conveying path and at a predefined conveying speed, and the syringes 10 with an RFID tag are arranged at a specific spacing determined by manufacturing requirements and specifications.

[0066] In order to retrieve the UID of each of these RFID-tagged syringes 10, the RFID-tagged syringes 10 are advanced along the conveyor system 72 to the position where they are read by the RFID reading system 76. Specifically, the RFID reading system 76 can perform a single read of the RFID tag 62 in each RFID-tagged syringe 10 to determine whether the RFID tag 62 is operable and / or meets specified quality control parameters. As previously described, the conveyor system 72 can operate as a high-throughput conveyor line that conveys the RFID-tagged syringes 10 along the conveyor path at a speed and at intervals achieving single reads of up to 6000 parts / minute. The RFID coupling element 80 is accordingly configured to enable such single reads of the RFID-tagged syringes 10 as they move along the conveyor system 72, while minimizing / eliminating the possibility of cross-reading defects during the reading of these RFID-tagged syringes 10.

[0067] To enable the RFID-tagged syringe 10 to be read by the RFID reading system 76, the RFID-tagged syringe 10 advances along the transport path to the reading position 108, where it passes in front of and near the RFID coupling element 80 of the RFID reading system 76. Figure 9 and Figure 10 As shown, now as Figure 11 and Figure 12As shown, as a non-limiting example, the RFID coupling element 80 can be positioned relative to the syringe 10 with the RFID tag (when they pass the read position 108) to ensure the correct reading of the RFID tag 62 therein, wherein the dipole coupling element 96 of the RFID coupling element 80 is vertically centered relative to the RFID tag 62 of the syringe (in the y-axis) and separated from it by a gap between 1 mm and 50 mm (in the z-axis). As previously described, the positioning of the RFID coupling element 80 (and its dipole coupling element 96) in the desired position can be provided by mounting and adjustment mechanisms provided on the structure of the RFID coupling element 80, wherein these mechanisms provide three-dimensional position adjustment.

[0068] When each syringe 10 with an RFID tag passes through the reading position 108 of the adjacent RFID coupling element 80, the RFID reading system 76 operates to perform a single read of each syringe 10 with an RFID tag. The process of performing this single read of each RFID tag 62 of each syringe 10 with an RFID tag by the RFID reading system 76 will now be explained in more detail.

[0069] According to some aspects of this disclosure, as an initial step in the reading process, a trigger signal is generated by PLC 84 and transmitted to RFID reader 78. As a non-limiting example, the trigger signal can be provided as a "high" trigger signal causing RFID reader 78 to initiate the reading process, or it can be provided as a "low" trigger signal, in which the RFID reader stops the reading process in response to the "low" trigger signal. The trigger signal can have an amplitude from 5 Vdc to 24 Vdc, depending on whether the trigger signal is high or low. According to one embodiment, the high and low trigger signals can be generated by PLC 84 based on signals received by PLC 84 from one or more sensors 90 that identify the position of the syringe 10 with an RFID tag on the delivery system 72 relative to the RFID coupling element 80, wherein this position information determines the appropriate time to trigger RFID reader 78 and RFID coupling element 80 to enable individual reading of each syringe 10 with an RFID tag. In other words, once one or more sensors 90 determine that the syringe 10 with the RFID tag is in front of or about to pass in front of the RFID coupling element 80 (i.e., the dipole coupling element 96 of the RFID coupling element), the trigger signal can be set high to cause the RFID reader 78 to initiate the reading process, and when one or more sensors 90 determine that the syringe 10 with the RFID tag is no longer in front of the RFID coupling element 80, the trigger signal can be set low to cause the RFID reader 78 to stop the reading process of the syringe 10 with the RFID tag. When performing the reading of the RFID tag 62, it should be understood, by way of non-limiting example, that the trigger position for the start / end of the reading of each syringe 10 with the RFID tag must therefore be consistent, wherein a tolerance of + / - 1.0 mm in the x-axis (the direction of travel of the syringe 10 with the RFID tag) is acceptable.

[0070] Although the operation of control system 82 is described above as one or more sensors 90 providing position information to PLC 84, and then PLC 84 transmitting a trigger signal to RFID reader 78, control system 82 can be modified to allow one or more sensors 90 to communicate directly with RFID reader 78 (e.g., ...). Figure 5(As shown by the dashed line in the middle), one or more sensors 90 are also configured to send trigger signals directly to the RFID reader 78. In such an embodiment, one or more sensors 90 can generate high and low trigger signals based on the positioning of the RFID-tagged syringe 10 on the delivery system 72 relative to the RFID coupling element 80, and provide these signals to the RFID reader 78 to control the timing of triggering the RFID reader 78 and the RFID coupling element 80, thereby enabling individual reading of each RFID-tagged syringe 10.

[0071] When the RFID reader 78 initiates the reading procedure (in response to a trigger signal), the RFID reader 78 sets up power and outputs power to the RFID coupling element 80 (i.e., to the dipole coupling element 96) to read the RFID-tagged syringe 10 currently located at the reading position 108. In some embodiments, the output power provided from the RFID reader 78 to the RFID coupling element 80 may be based on the separation distance (in the z-axis) between the RFID coupling element 80 and the RFID tag 62 of the RFID-tagged syringe 10, as a larger separation distance may require more power. The output power provided by the RFID reader 78 to the RFID coupling element 80 electromagnetically couples the dipole coupling element 96 of the RFID coupling element 80 to the RFID tag 62 of the corresponding RFID-tagged syringe 10 at the reading position 108. In some embodiments, the electromagnetic field generated by the dipole coupling element 96 of the RFID coupling element 80 may be configured as a conical electromagnetic field of finite size / coverage, focused toward the single RFID-tagged syringe 10 passing through the reading position 108.

[0072] Based on all aspects of this disclosure, and as follows Figure 11 As best shown, the reading of the RFID tag 62 (in response to a high trigger signal) of the syringe 10 with the RFID tag can occur when the syringe with the RFID tag passes through the reading position 108, and when the RFID tag 62 is aligned with the dipole coupling element 96. In some embodiments, as a non-limiting example, the RFID tag 62 of each syringe 10 with the RFID tag can be aligned with the dipole coupling element 96 (in the x-axis) within a minimum reading time period of approximately 6 ms in order to enable correct reading of the RFID tag 62. It should be recognized that the width of the end 112 of the dipole coupling element 96 (in the x-axis) and the speed of the delivery system 72 affect the reading time period, and therefore the reading time period can be different.

[0073] According to various aspects of this disclosure, the electromagnetic coupling of the RFID coupling element 80 at the read position 108 with the corresponding RFID tag 62 of the syringe 10 bearing the RFID tag can generate a response from the RFID tag 62 of 800 MHz to 1000 MHz (i.e., across the entire RFID UHF bandwidth) with an accuracy of + / - 10 dB. The response from the RFID tag 62 can be detected by the RFID reader 78, which retrieves a unique UID from the RFID tag 62. According to some aspects of this disclosure, the RFID reader 78 can optionally be programmed or configured to output the UID to a server / database 86, which receives the UID generated by reading the syringe 10 bearing the RFID tag from the RFID reader 78 and stores the reading result / UID in a storage module.

[0074] Regarding the reading of each RFID-tagged syringe 10 as described above, it should be recognized that a certain number of RFID-tagged syringes 10 transported along the conveying system 72 may fail to pass the reading operation performed by the RFID reading system 76. For example, the RFID tag 62 of a corresponding RFID-tagged syringe 10 may be inoperable / defective, such that when the RFID reading system 76 attempts to read the RFID tag, no response is received from that RFID tag 62 (i.e., no UID is retrieved). According to aspects of this disclosure, the RFID reader 78 or controller 86 is configured to determine / identify when the RFID tag 62 of each corresponding RFID-tagged syringe 10 is successfully or unsuccessfully read, wherein the RFID reader 78 generates an appropriate "pass" or "fail" signal in response.

[0075] If the RFID reader 78 successfully reads the RFID tag 62 of each corresponding syringe 10 with an RFID tag and retrieves the UID from it, the RFID reader 78 can generate a pass signal and transmit the pass signal to the PLC 84. Alternatively, the RFID reader 78 can output the successfully read UID to the server / database 86 for storage.

[0076] If the RFID reader 78 cannot read the RFID tag 62 of each corresponding syringe 10 with an RFID tag (and cannot retrieve the UID), the RFID reader 78 can generate a failure signal and send the failure signal to the PLC 84. In some embodiments, receiving the failure signal causes the PLC 84 to generate / output a command that causes the conveying system 72 to remove the failed syringe 10 with an RFID tag from the conveying path. For example, a holding or clamping device 74 that holds the failed syringe 10 with an RFID tag can receive the command signal and, in response, release / remove the failed syringe 10 with an RFID tag from the conveying system 72.

[0077] As described above, the RFID reading system 76 operates to provide a single, individual read for each of the RFID-tagged syringes 10 conveyed by the delivery system 72. Therefore, it should be understood that the operating method of the RFID reading system 76 described in detail above is repeatedly used to read each RFID-tagged syringe 10. This single, individual read of each of the RFID-tagged syringes 10 can be used as part of a quality control check to ensure the operability of the RFID tag 62 in each RFID-tagged syringe 10.

[0078] Therefore, embodiments of the present invention advantageously relate to a system and method for reading RFID-tagged medical devices during the manufacture of such devices. The system and method provide accurate, individualized readings of RFID tags incorporated into such RFID-tagged medical devices, based on the required spacing and transport speed associated with the manufacturing environment of the RFID-tagged medical devices, and achieve high read throughput (up to 6000 parts / minute). An RFID coupling element is provided that is capable of individualized readings of RFID tags in each RFID-tagged medical device as it moves along a transport system at high speed and with minimal spacing, wherein the possibility of cross-read defects is minimized while providing such readings. The ability to individualize the RFID tags in each RFID-tagged medical device allows the RFID reading system to retrieve a unique identifier from each RFID-tagged medical device. In some embodiments, during manufacturing, the individualized reading of RFID tags in each RFID-tagged medical device can be performed as a quality control check of the RFID-tagged medical devices, wherein defective RFID-tagged medical devices are identified and removed from the transport system. Therefore, more stringent quality control can be implemented during the high-throughput manufacturing / assembly of medical devices with RFID tags.

[0079] While this disclosure has been described in detail for illustrative purposes based on embodiments or aspects currently considered most practical and preferred, it should be understood that such detailed description is for that purpose only, and that this disclosure is not limited to the disclosed embodiments or aspects. Rather, this disclosure is intended to cover modifications and equivalent arrangements within the spirit and scope of the appended claims. For example, it should be understood that this disclosure contemplates that, to the extent possible, one or more features of any embodiment may be combined with one or more features of any other embodiment.

Claims

1. A method for performing a reading on each of a plurality of medical devices bearing radio frequency identification (RFID) tags, the method comprising: Each of a plurality of RFID-tagged medical devices is transported along a transport path via a transport system, each of the plurality of RFID-tagged medical devices including an integrated RFID tag. An RFID reading system is provided at a location along the transport path, the RFID reading system comprising: An RFID coupling element, positioned at a reading location along the transmission path, the RFID coupling element comprising a dipole coupling element; and An RFID reader, which is operatively connected to the RFID coupling element; When the plurality of medical devices with RFID tags pass the reading location, the RFID reading system performs a single reading on each of the plurality of medical devices with RFID tags; and The unique identifier (UID) of each of the plurality of medical devices with RFID tags is retrieved based on a single read of the RFID tags.

2. The method of claim 1, wherein, When retrieving the UID of each of the plurality of medical devices with RFID tags, the method includes operating the RFID reader to: Determine whether the RFID tag of the corresponding medical device with the RFID tag has been successfully read; If the RFID tag is not successfully read, a failure signal is generated for the medical device corresponding to the RFID tag. as well as The failure signal is transmitted to a controller operatively connected to the RFID reader.

3. The method of claim 2, wherein, When transmitting the failure signal to the controller, the RFID reader transmits the failure signal to the computer responsible for communicating with the controller, and then the computer sends the failure signal to the controller.

4. The method according to claim 1, further comprising: The failure signal is received at the controller. as well as The controller outputs a command to cause the delivery system to remove the failed RFID-tagged medical device from the delivery path.

5. The method of claim 1, wherein, The medical device with an RFID tag includes one of a syringe, an auto-injector, or a safety device.

6. The method of claim 5, wherein, The medical device with an RFID tag includes a syringe, wherein the RFID tag of each syringe is embedded in or applied to one of the syringe's end cap, barrel, flange, or plunger rod.

7. The method of claim 6, wherein, The curvature of the RFID tag matches the curvature of the syringe tip cap or barrel.

8. The method according to claim 1, wherein, When performing a single read on a medical device with an RFID tag, the RFID reader reads the medical device with the RFID tag over a period of 6 ms or longer.

9. The method of claim 1, further comprising: The RFID coupling element is positioned relative to the RFID tag in each of the plurality of medical devices with RFID tags, such that the polarization axis or dipole axis of the RFID coupling element is substantially parallel to the polarization axis or dipole axis of the RFID tag.

10. The method of claim 9, wherein, The parallelism between the polarization axis or dipole axis of the RFID coupling element and the polarization axis or dipole axis of the RFID tag is within + / -30 degrees.

11. The method of claim 1, wherein, When transporting the plurality of RFID-tagged medical devices, the spacing between the center lines of the RFID tags of adjacent RFID-tagged medical devices being transported is 19 mm or greater, and wherein, the individual reading of each of the plurality of RFID-tagged medical devices via the RFID coupling element and the RFID reader prevents cross-reading of one RFID-tagged medical device with other adjacent RFID-tagged medical devices.

12. The method of claim 1, wherein, When transporting the plurality of medical devices with RFID tags, the spacing between adjacent medical devices with RFID tags is 3 mm or greater.

13. The method of claim 1, further comprising: Position the RFID coupling element such that when the corresponding medical device with the RFID tag is located at the reading position, it is separated from the medical device with the RFID tag by 1 mm to 50 mm.

14. The method of claim 13, further comprising: The output power from the RFID reader to the RFID coupling element is set based on the separation distance between the RFID coupling element and the medical device with the RFID tag.

15. The method of claim 1, further comprising: The RFID coupling element is positioned at the reading position such that when the corresponding medical device with an RFID tag is located at the reading position, the dipole coupling element of the RFID coupling element is vertically centered relative to the RFID tag in the medical device with the RFID tag.

16. The method of claim 1, wherein, The transmission path includes a linear transmission path or a circular transmission path, and wherein the transmission system transmits the plurality of RFID-tagged medical devices along the transmission path at a transmission speed and at intervals that allow for individual readings of up to 6,000 parts per minute.

17. The method according to claim 1, wherein, When performing a single read on each of the plurality of medical devices with RFID tags, the method includes operating the RFID reader to: Receive trigger input signals from the controller or sensor associated with the RFID reader; In response to receiving the trigger signal, the RFID coupling element is electromagnetically coupled to the corresponding medical device with an RFID tag; as well as Once the RFID coupling element is electromagnetically coupled to the corresponding medical device with an RFID tag, a single reading is performed on the medical device with the RFID tag.

18. The method of claim 17, further comprising: The sensor senses when a corresponding medical device with an RFID tag is located at the reading position, where the medical device with an RFID tag passes in front of and near the RFID coupling element; as well as Once the RFID-tagged medical device is detected to be located at the reading position, the trigger signal is generated from the controller.

19. An RFID reading system for performing a single read of each of a plurality of medical devices bearing radio frequency identification (RFID) tags, which are transported along a transport path by a transport system at a transport speed, wherein, Each of the plurality of RFID-tagged medical devices includes an integrated RFID tag, and the RFID reading system includes: An RFID coupling element, positioned at a reading location along the transmission path, the RFID coupling element comprising a dipole coupling element; and An RFID reader, operably connected to the RFID coupling element, is configured to selectively provide reading of the RFID tags of each of the plurality of medical devices with RFID tags, the RFID reader being configured to: At the reading location, once a medical device with an RFID tag passes in front of and near the RFID coupling element, a single RFID tag reading is performed on the medical device's RFID tag; and Based on the reading or failure of the RFID tag of the medical device with the RFID tag, a pass / fail signal is output for the medical device with the RFID tag.

20. The RFID reading system according to claim 19, wherein, The polarization axis or dipole axis of the RFID coupling element is substantially parallel to the polarization axis or dipole axis of the RFID tag in each of the plurality of medical devices with RFID tags.

21. The RFID reading system of claim 20, wherein, The medical device with an RFID tag includes one of a syringe, an auto-injector, or a safety device.

22. The RFID reading system of claim 21, wherein, The medical device with an RFID tag includes a syringe, wherein the RFID tag of each syringe is embedded in or applied to one of the syringe's end cap, barrel, flange, or plunger rod.

23. The RFID reading system of claim 19, wherein, When outputting the pass / fail signal for each of the plurality of medical devices with RFID tags, the RFID reader is further configured to: Determine whether the RFID tag of the corresponding medical device with an RFID tag has been successfully read; and If the RFID tag is not successfully read, a failure signal is generated for the corresponding medical device with the RFID tag.

24. The RFID reading system of claim 23, wherein, The RFID reading system further includes a programmable logic controller, which is configured to: Receive pass / fail signals for each corresponding medical device with an RFID tag; as well as When the pass / fail signal for the corresponding RFID-tagged medical device is a failure signal, the conveying system removes the failed RFID-tagged medical device from the transport path.

25. The RFID reading system of claim 24, wherein, The RFID reading system is configured to: The controller or sensor associated with the RFID reader receives a trigger input signal indicating that a medical device with a corresponding RFID tag is passing in front of and near the RFID coupling element at the reading location; In response to receiving the trigger signal, the RFID coupling element is electromagnetically coupled to the RFID tag of the corresponding medical device with an RFID tag; as well as Once the RFID coupling element is electromagnetically coupled to the corresponding medical device with an RFID tag, a single reading is performed on the medical device with the RFID tag.

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