System and method for leak detection of a medical injection device with an RFID tagged needle guard

Abstract

A system for detecting needle shield penetration in medical injection devices tagged with RFID is provided herein. The system includes a transport system configured to transport injection devices along a transport path, an RFID coupling element positioned at a read location along the transport path, an RFID reader configured to perform a singulated read of an RFID tag of each injection device as each injection device passes the RFID coupling element, and a processor coupled to a memory and configured to, for each RFID tag read by the RFID reader, record a carrier power required to send a signal from the RFID coupling element to the RFID tag that produces a backscatter signal response from the RFID tag, compare the recorded carrier power to a specified reference carrier power threshold, and identify the corresponding injection device as having a penetrated needle shield if the recorded carrier power is greater than the reference carrier power threshold.

Description

Cross-reference to related applications

[0001] This application claims priority to European Patent Application No. 23209174.4, filed on November 10, 2023, entitled “System and Method for LeakDetection in a Medical Injection Device having a RFID-Tagged Needle Shield,” the disclosure of which is incorporated herein by reference in its entirety. #imgpt0# Technical Field

[0002] This disclosure generally relates to medical injection devices including RFID tags on needle shields, and more particularly to systems and methods for detecting needle shield leakage by reading RFID tags on medical injection devices.

[0003] Description of related technologies Syringes are used in various settings for administering fluids to patients, such as medications or other drugs. Syringes can be supplied as pre-filled or pre-fillable syringes, which offer the convenience of rapidly delivering the liquid to a patient without first aspirating the medication from another container and measuring its volume. Syringes typically include a syringe barrel with a distal and a proximal end. A needle is attached to the distal end for injecting the fluid into the patient, and a plunger assembly is inserted through the proximal end. This plunger assembly is movable within the barrel to force fluid out of the syringe through the needle.

[0004] It should be recognized that the syringe must be handled with care before and after use due to the presence of the needle. To minimize the risk of accidental injury due to needle prick, syringes typically include a needle guard that covers the sharp tip of the needle. Before use, the needle guard is removed to expose the sharp tip of the needle. This guard also serves to protect the sharp tip of the needle and maintain the sterility of the syringe contents and syringe parts that come into contact with the patient's skin. The needle guard is typically formed to include a rigid component and a flexible component, or "jupe." The flexible component is typically formed of elastic rubber (e.g., isoprene rubber, butyl rubber, latex rubber, or silicone rubber), which provides a strong, sealed connection to the syringe at least along the sealing line, while the rigid component provides protection against accidental needle pricks and provides an easy-grip surface for the user to remove the needle guard from the syringe.

[0005] During the syringe manufacturing process described above, quality control checks / tests can be performed to ensure that the syringe meets the established specifications. For example, quality control tests can be performed on the syringe to check whether the needle shield is punctured by the needle during placement onto the syringe needle. It can be recognized that such puncture of the needle shield may lead to leakage, which compromises the integrity of the syringe container seal. Existing systems and methods for detecting needle shield punctures (and associated leaks) typically employ high-voltage leak detection (HVLD) techniques or visual inspection techniques; however, it should be recognized that each of these detection / inspection techniques has its associated limitations or drawbacks.

[0006] HVLD is a method for detecting package leaks by applying a high voltage. The HVLD detection method works based on the principles of resistance and capacitance. For HVLD to be used to test packages such as syringe needle shields, the needle shield must be made of a non-conductive material (e.g., plastics and elastomers), and the internal product (e.g., the drug within the syringe barrel to which the shield is attached) must be conductive. The needle shield will be exposed to a high voltage between at least two probes, one of which applies the high voltage to the needle shield, while the second probe is a ground source. If there is a leak in the needle shield, the resistance of the needle shield wall decreases, and the voltage will be conducted through the needle shield—the leak is identified by detecting / measuring this voltage. However, it should be recognized that for HVLD to be used to test syringe needle shields, the drug must already be loaded / filled into the syringe at the time of testing, which may limit the time / location of testing during the manufacturing process.

[0007] Using visual inspection to detect leaks in syringe needle sheaths is an inspection technique that involves inspecting needle sheaths using a visual inspection system (e.g., an image capture device and an associated image processor). However, detecting leaks in needle sheaths using a visual inspection system requires a clear line of sight to both the needle sheath and the needle contained within it (the transparent sheath) in order to determine the needle's position relative to the sheath. It should be recognized that some next-generation needle sheaths may incorporate RFID tags that provide individual identification and traceability of the syringe during / after manufacturing; however, these RFID tags may at least partially surround the needle sheath, thus obstructing the line of sight between the visual inspection system and a portion of the needle sheath and / or the line of sight to the needle inside the sheath. In other words, the antenna of an RFID tag made of a conductive material such as aluminum or copper can surround a portion of the needle sheath, thus obstructing the line of sight to the needle and hindering the use of a visual inspection system for leak detection.

[0008] Therefore, there is a need in the art for a system and method that can inspect needle guards to detect leaks caused by syringe needles puncturing them. Ideally, this system and method would employ a leak detection technique other than HVLD or visual inspection, capable of detecting leaks at different points / times during the manufacturing cycle (e.g., before filling the syringe with medication) and / or on various types of syringe needle guards—and specifically for RFID-tagged needle guards. This system and method can be advantageously used to detect punctured needle guard defects, in addition to conventional HVLD or visual inspection systems, when the puncture needle is completely concealed by the RFID tag antenna. Summary of the Invention

[0009] This invention provides a system for detecting needle piercing in a medical injection device with multiple RFID tags, each of which has an integrated RFID tag in the needle shroud. The system includes: a delivery system configured to deliver a plurality of RFID-tagged medical injection devices along a delivery path; an RFID coupling element positioned at a read position along the delivery path; an RFID reader operatively connected to the RFID coupling element and configured to selectively read the RFID tag of each RFID-tagged medical injection device as it passes the RFID coupling element at the read position; and at least one processor coupled to a memory and configured to: for each RFID tag read by the RFID reader, record the carrier power required to generate a backscattered signal response from the RFID tag in the signal transmitted from the RFID coupling element to the RFID tag; compare the carrier power provided to each RFID tag with a specified reference carrier power threshold; and if the carrier power provided to the RFID tag read by the RFID reader is greater than the reference carrier power threshold, identify the RFID-tagged medical injection device as having a punctured needle sheath.

[0010] According to some aspects of this disclosure, the reference carrier power threshold includes the minimum carrier power required to generate a backscattered signal from an RFID tag for a medical injection device with an RFID tag having a full needle shield.

[0011] According to some aspects of this disclosure, the reference carrier power threshold includes a carrier power curve against frequency.

[0012] According to some aspects of this disclosure, the reference carrier power threshold is -1.5 dBm for 865 MHz, -5.5 dBm for 915 MHz, and -1.5 dBm for 960 MHz.

[0013] According to some aspects of this disclosure, the at least one processor is further configured to determine a reference carrier power threshold based on multiple reference readings obtained from a medical injection device with multiple RFID tags having a complete needle shield, the reference readings being the carrier power required to generate a backscatter signal response from the RFID tag of the RFID-tagged medical injection device.

[0014] According to some aspects of this disclosure, the system further includes at least one trigger sensor configured to detect when an individual RFID-tagged medical injection device is in a reading position, wherein, for each of a plurality of RFID-tagged medical injection devices on the delivery system, the at least one sensor is configured to send a trigger signal to an RFID reader in response to detecting that the corresponding RFID-tagged medical injection device is in a reading position, so that the RFID reader reads the RFID tag of the RFID-tagged medical injection device, and wherein the RFID reader is configured to read the RFID tag on the corresponding RFID-tagged medical injection device in response to receiving the trigger signal from the at least one sensor.

[0015] According to some aspects of this disclosure, at least one processor is further configured to: in response to identification of a medical injection device with a corresponding RFID tag having a punctured needle guard, control the delivery system to eject the RFID-tagged medical injection device from the delivery system.

[0016] According to some aspects of this disclosure, a medical injection device with multiple RFID tags includes multiple syringes.

[0017] According to some aspects of this disclosure, the RFID coupling element includes a near-field coupling element that is placed at a distance of 1 mm to 20 mm from the RFID tag when the medical injection device with the corresponding RFID tag passes the reading position.

[0018] According to some aspects of this disclosure, the delivery system is configured to deliver multiple RFID-tagged medical devices past the read location at a rate of up to 1000 pieces / minute.

[0019] This document also provides a method for detecting needle shield puncture in each of a plurality of RFID-tagged medical injection devices having a needle shield in which an RFID tag is integrated. 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 RFID tag integrated with its needle shield. The method further includes setting an RFID reading system at a location along the conveying path, the RFID reading system including: an RFID coupling element positioned at a reading location along the conveying path; and an RFID reader operatively connected to the RFID coupling element. The method further includes: performing a single reading of the respective RFID-tagged medical device via the RFID reading system as each of the plurality of RFID-tagged medical devices passes the reading location; and identifying a potential needle shield puncture in each of the respective RFID-tagged medical devices by at least one processor based on the reading of each of the plurality of RFID-tagged medical devices. When identifying potential needle shield punctures, the method includes: for each RFID tag, recording the carrier power required to generate a backscattered signal response from the RFID tag for a signal transmitted from an RFID coupling element to the RFID tag; comparing the carrier power provided to each corresponding RFID tag with a specified reference carrier power threshold; and if the carrier power provided to the corresponding RFID tag read by an RFID reader is greater than the reference carrier power threshold, identifying the medical injection device of the corresponding RFID tag as having a punctured needle shield.

[0020] According to some aspects of this disclosure, the reference carrier power threshold includes the minimum carrier power required to generate a backscattered signal from an RFID tag for a medical injection device with an RFID tag having a full needle shield.

[0021] According to some aspects of this disclosure, the method further includes: in response to a medical injection device with a corresponding RFID tag being identified as having a punctured needle guard, controlling the delivery system to eject the RFID-tagged medical injection device from the delivery system.

[0022] According to some aspects of this disclosure, the method further includes: using at least one trigger sensor to detect when a medical injection device with an individual RFID tag is in a reading position; and in response to detecting that the medical injection device with the RFID tag is in a reading position, sending a trigger signal from the at least one trigger sensor to an RFID reader to cause the RFID reader to read the RFID tag of the medical injection device with the corresponding RFID tag.

[0023] According to some aspects of this disclosure, the method further includes positioning an RFID coupling element at a reading position such that when a medical injection device with a corresponding RFID tag passes the reading position, the RFID coupling element is placed at a distance of 1 mm to 20 mm from the RFID tag.

[0024] This article also provides a system for detecting needle piercing in a medical injection device with multiple RFID tags, each of which has an RFID tag integrated into the needle piercing. The system includes: a delivery system configured to deliver a plurality of RFID-tagged medical injection devices along a delivery path; an RFID coupling element positioned at a read position along the delivery path; an RFID reader operatively connected to the RFID coupling element and configured to selectively read the RFID tags of the RFID-tagged medical injection devices as each corresponding RFID-tagged medical injection device passes the RFID coupling element at the read position; and at least one processor coupled to a memory and configured to: determine the tag sensitivity of the RFID tag of each of the plurality of RFID-tagged medical injection devices read by the RFID reader, compare the tag sensitivity of each RFID tag with a predetermined normal tag sensitivity range, and identify the corresponding RFID-tagged medical injection device as having a punctured needle shield if the tag sensitivity of the corresponding RFID tag is outside the normal tag sensitivity range.

[0025] According to some aspects of this disclosure, the at least one processor is also configured to determine a normal tag sensitivity range based on multiple reference readings obtained from a medical injection device with multiple RFID tags having a full needle shield.

[0026] According to some aspects of this disclosure, when determining tag sensitivity, the at least one processor is configured to: for each RFID tag read by the RFID reader, record the carrier power required to generate a backscattered signal response from the RFID tag, which is transmitted from the RFID coupling element to the RFID tag; and wherein, when comparing the tag sensitivity of each RFID tag with a predetermined normal tag sensitivity range, the at least one processor is configured to: compare the carrier power with a specified reference carrier power threshold, wherein when the recorded carrier power of the corresponding RFID tag read by the RFID reader is greater than the reference carrier power threshold, the medical injection device of the corresponding RFID tag is identified as having a punctured needle sheath.

[0027] According to some aspects of this disclosure, at least one processor is further configured to: in response to identification of a medical injection device with a corresponding RFID tag having a punctured needle guard, control the delivery system to eject the RFID-tagged medical injection device from the delivery system.

[0028] According to some aspects of this disclosure, the RFID coupling element includes a near-field coupling element that is placed at a distance of 1 mm to 20 mm from the RFID tag when the medical injection device with the corresponding RFID tag passes the reading position. Attached Figure Description

[0029] Figure 1A This is a perspective view of an RFID-tagged syringe, which can be used to implement embodiments of the present disclosure. Figure 1B yes Figure 1A An exploded view of the syringe; Figure 1C Is included Figure 1A A side view of the needle guard in a syringe; Figure 2 An environment according to a non-limiting embodiment described herein is illustrated, in which a medical injection device (e.g., for multiple RFID tags) can be used. Figure 1A A method for reading and testing using a syringe; Figure 3 yes Figure 4 A schematic diagram of a non-limiting embodiment or aspect of a component of one or more devices and / or one or more systems; and Figure 4 This is a flowchart illustrating the process of needle piercing in a medical injection device for detecting RFID tags according to a non-limiting embodiment described herein. Detailed Implementation

[0030] The following description is provided to enable those skilled in the art to make and use the described embodiments intended for carrying out the invention. However, various modifications, equivalents, variations, and substitutions will still be apparent to those skilled in the art. Any and all of these modifications, variations, equivalents, and substitutions are intended to fall within the spirit and scope of the invention.

[0031] 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 employ various alternative variations unless explicitly stated otherwise. It should also be understood that the specific devices shown in the accompanying drawings and described in the following specification are merely exemplary embodiments of the invention. Therefore, specific dimensions and other physical features associated with the embodiments disclosed herein should not be considered limiting.

[0032] 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 is holding the syringe during preparation or use), and the proximal end 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 is holding the syringe during preparation or use). Similarly, in this application, the terms "in the distal direction" and "towards the distal end" refer to a direction toward the distal end of the syringe, while the terms "in the proximal direction" and "towards the proximal end" refer to a direction opposite to the direction of the distal end of the syringe.

[0033] As used herein, the terms "communication" and "transmission" can refer to the receipt, transmission, transfer, and / or provision of information (e.g., data, signals, messages, instructions, and / or commands). For a unit (e.g., an apparatus, system, component of an apparatus or system, and / or a combination thereof), communicating with another unit means that the first unit is able to receive information directly or indirectly from and / or send information to the other unit. This can refer to a direct or indirect connection of a wired and / or wireless nature. Furthermore, the two units can communicate with each other even if the information transmitted between the first and second units can be modified, processed, relayed, and / or routed. For example, the first unit can communicate with the second unit even if it passively receives information and does not actively send information to the second unit. As another example, the first unit can communicate with the second unit if at least one intermediate unit (e.g., a third unit located between the first and second units) processes information received from the first unit and transmits the processed information to the second unit. In some non-limiting embodiments or aspects, a message can refer to a network packet (e.g., a data packet, etc.) that includes data. It will be recognized that many other settings are possible.

[0034] As used herein, the term "computing device" can refer to one or more electronic devices configured to communicate directly or indirectly with or through one or more networks. A computing device can be a mobile or portable computing device, a desktop computer, a server, and / or similar devices specifically configured to provide one or more of the features and / or functions described herein. Furthermore, the term "computer" can refer to a specially configured computing device that includes the necessary components for receiving, processing, and outputting data according to the aspects described herein, and typically includes a display, processor, memory, input devices, and network interfaces. A "computing system" can include one or more computing devices or computers. "Application" or "application program interface (API)" refers to computer code or other data stored on a computer-readable medium that can be executed by a processor to facilitate interaction between software components, such as a client-side front-end and / or a server-side back-end for receiving data from a client. "Interface" refers to a generated display, such as one or more graphical user interfaces (GUIs) with which a user can interact directly or indirectly (e.g., via a keyboard, mouse, touchscreen, etc.). Furthermore, multiple computers (e.g., servers or other computerized devices) that communicate directly or indirectly in a network environment can constitute a "system" or a "computing system".

[0035] As used herein, the term "communication network" can refer to one or more wired and / or wireless networks. For example, a communication network can include cellular networks (e.g., long-term evolution (LTE) networks, third-generation (3G) networks, fourth-generation (4G) networks, fifth-generation (5G) networks, code division multiple access (CDMA) networks, etc.), public land mobile networks (PLMNs), local area networks (LANs), wide area networks (WANs), metropolitan area networks (MANs), telephone networks (e.g., public switched telephone networks (PSTNs)), private networks, ad hoc networks, intranets, the Internet, fiber-optic networks and / or cloud computing networks, etc., and / or combinations of these or other types of networks.

[0036] Clearly, the systems and / or methods described herein can be implemented in various forms, such as hardware, firmware, or a combination of hardware and software. The actual dedicated control hardware or software code used to implement these systems and / or methods is not limited to these implementations. Therefore, while the operation and behavior of the systems and / or methods are described herein without mentioning specific software code, it will be understood that software and hardware can be designed to implement the systems and / or methods based on the descriptions herein.

[0037] This document describes some non-limiting embodiments or aspects in conjunction with thresholds. As used herein, satisfying a threshold can mean a value that is greater than a threshold, more than a threshold, higher than a threshold, greater than or equal to a threshold, less than a threshold, lower than a threshold, less than or equal to a threshold, equal to a threshold, or within a range specified by a threshold.

[0038] Unless explicitly stated otherwise, aspects, parts, elements, structures, actions, steps, functions, and / or instructions used herein should not be construed as critical or necessary. Furthermore, as used herein, the article “a (a, an)” is intended to include one or more items and may be used interchangeably with “one or more” and “at least one.” Additionally, as used herein, the term “set” / kit is intended to include one or more items (e.g., related items, unrelated items, combinations of related and unrelated items, etc.) and may be used interchangeably with “one or more” or “at least one.” The term “a” or similar language is used where only one item is referred to. Furthermore, as used herein, the terms “having,” “possessing,” or “with” are intended to be open-ended terms. Additionally, unless explicitly stated otherwise, the phrase “based on” is intended to mean “at least partially based on.”

[0039] refer to Figure 1A and Figure 1B This illustration shows a non-limiting embodiment of an RFID-tagged medical injection device 10, which can be used to implement aspects or embodiments of this disclosure. Although the medical device is shown and described below as a syringe (“syringe 10”), it should be understood that other RFID-tagged medical devices, including other medical injection devices (e.g., autoinjectors), can be used in conjunction with the systems and methods of this disclosure described in detail below.

[0040] like Figure 1A and Figure 1BAs shown, syringe 100 typically includes a syringe barrel 102 and a plunger assembly 104. For example, plunger assembly 104 can be moved along a longitudinal axis within syringe barrel 102 to an advanced position to facilitate administration of an injectable fluid (e.g., a drug) to a patient. Syringe barrel 102 is formed by a generally cylindrical outer wall 106 and a distal member 108, which together define a chamber 110 for retaining fluid therein. Syringe barrel 102 includes an open proximal end 112 and a distal end 114, the proximal end 112 being configured to receive plunger assembly 104 therein, and the distal member 108 being positioned at the distal end 114. The proximal end 112 of syringe barrel 102 may include a flange 116 to facilitate manipulation and positioning of syringe 100 and to maintain the relative position of syringe barrel 102 with respect to plunger assembly 104 during drug administration. At the distal end 114, the end member 108 may include a shoulder 118 that narrows relative to a cylindrical outer wall 106, and a needle seat portion 120 extending distally from the shoulder 118. The needle seat portion 120 is formed as a partially hollow member defining a channel 122 from one end to the other, which is in fluid communication with the chamber 110. A needle 124 is attached to the needle seat portion 120 within the channel 122, for example by gluing or otherwise securing it to the needle seat portion 120, and extends distally from the needle seat 120 to a distal needle tip 125.

[0041] The plunger assembly 104 of the syringe 100 is formed by an elongated plunger rod 126 (hereinafter more generally referred to as "plunger 126") and a plunger head or stopper 128. The plunger 126 may include a body 130 extending between a proximal plunger end 132 and a distal plunger end 134. In some embodiments, the body 130 may include a plurality of elongated blades or walls 136 extending axially along the length of the body 130 between the proximal plunger end 132 and the distal plunger end 134. A thumb press 138 is positioned at the proximal plunger end 132, which can be engaged by a user's thumb (or other finger) to apply a distally directed force to the plunger assembly 104, thereby moving the plunger rod 126 relative to the syringe barrel 102. In some embodiments, a flange extension 140 (e.g., a disc-shaped flange) is positioned at the distal plunger end 134, the flange extension 140 being configured to engage with the stopper 128. In other embodiments, the distal end 134 of the plunger may include a female receptacle formed therein, which is configured to receive and connect a protrusion (e.g., a pin) extending proximally from the plunger, for example, the protrusion and the receiving groove being threaded together.

[0042] like Figure 1A and Figure 1BAs shown, the needle guard 150 of the syringe assembly 102 can be coupled to the syringe barrel 102 to protect the needle 124. According to various aspects of this disclosure, the needle guard 150 can consist of a rigid outer shell 152 and a compliant inner shell or "inner sleeve" 154, the rigid outer shell 152 providing structure for the needle guard 150 when the needle guard 150 is coupled to the syringe barrel 102, the compliant inner shell or "inner sleeve" 154 surrounding the needle 124. In various embodiments, the outer shell 152 may be made of a rigid material, such as polypropylene (PP), polyethylene (PE), polyethylene terephthalate (PET), polystyrene (PS), or polycarbonate (PC), while the inner shell 154 may be made of a deformable material, such as rubber (e.g., butyl rubber, isoprene rubber, latex rubber, silicone rubber) or thermoplastic elastomer (TPE) as a non-limiting example. The outer shell 152 and inner shell 154 of the needle guard 150 are formed as separate components, which may be fixed together to form the needle guard 150, wherein each shell 152, 154 is formed by a separate manufacturing process—for example, the outer shell 152 is formed by injection molding, and the inner shell 154 is formed by injection molding (if it is TPE) or compression molding (if it is rubber). When the needle guard 150 is secured to the syringe barrel 102 (i.e., to the needle hub 120), the needle 124 extends through a cavity defined in the inner housing 154, such that the needle tip 125 protrudes from the cavity to reach the compliant material of the inner housing 154—that is, the needle tip 125 pierces and extends into the compliant material, thereby sealing the needle tip 125 within the compliant material of the inner housing 154. With the needle tip 125 properly sealed within the compliant material of the inner housing 154, fluid leakage from the needle 124 is prevented.

[0043] According to aspects and embodiments of this disclosure, the needle shield 150 may include an RFID tag 156 integrated therein, which allows identification and / or tracking of the syringe 100. That is, the RFID tag 156 may include or store information thereon regarding the contents of the syringe 100 (i.e., if it is a pre-filled syringe, the contents are the drug or pharmaceutical product included in the syringe 100) and the manufacturing history of the syringe, and / or may provide location information to an associated reader to enable tracking of the syringe 100. Therefore, the RFID tag 156 is considered to typically include a unique identifier (UID) specific to the syringe 100. According to aspects or embodiments of this disclosure, the RFID tag 156 may be integrated into the needle shield 150, for example, by embedding or otherwise disposed between the outer housing 152 and the inner housing 154 of the needle shield 150. According to other embodiments, the RFID tag 156 may be applied to the outer surface of the needle shield 150. In each of these embodiments, the RFID tag 156 conforms to one or more surfaces or walls on which it is disposed or disposed therein, such that when the RFID tag 156 is integrated with a cylindrical component (e.g., a needle guard 150) or when the RFID tag 156 is integrated onto the cylindrical component, the RFID tag 156 will have a curvature that matches the curvature of the needle guard 150.

[0044] According to various embodiments, such as Figure 1C As shown, the RFID tag 156 includes an RFID chip 158 connected to an RFID dipole coupling element or antenna 160. The antenna 160 of the RFID tag 156 may include two legs or two dipole elements D2, D1, wherein the RFID chip 158 is disposed between the ends of legs D2 and D1, for example, centrally disposed between the two poles. In some embodiments, the RFID tag 156 may be positioned and oriented within the needle sheath 150 such that the dipole axis A of the RFID tag 156 is... D With the longitudinal axis A of the needle guard 150 C (and the longitudinal axis A of syringe 100) S The syringe 100 and its cap 150 are roughly aligned, which allows for more stringent quality control during the manufacturing / assembly of the syringe 100 and its cap 150.

[0045] Now for reference Figure 2 It illustrates a manufacturing and reading environment or system 200 according to one aspect of this disclosure, in which or through which RFID tags of medical injection devices (e.g., [missing information]) can be read. Figures 1A to 1C(The RFID-tagged syringe 100). According to aspects of this disclosure, reading of the RFID-tagged medical injection device can therefore be implemented as part of a quality control process, including detecting whether the needle guard of each injection device has been punctured by the needle during its placement on the needle, wherein it should be recognized that such puncture of the needle guard may lead to leakage that compromises the container closure integrity of the syringe.

[0046] like Figure 2 As shown, system 200 may include: a plurality of medical injection devices 201a (hereinafter referred to as "syringes 201a"), the medical injection device 201a including a plurality of RFID tags 201b integrated on its needle sheath 201c; a controller system 202; an RFID reader 204 including an RFID coupling element 205 (collectively referred to as "RFID reading system"); a trigger sensor 206; a delivery system 208 including a conveyor 209 and / or an ejector mechanism 210; and a database system 211.

[0047] Multiple RFID tags 201b on multiple syringes 201a may include passive RFID tags, active RFID tags, or any combination thereof. The multiple RFID tags 201b may store identifiers associated with the multiple syringes 201a. For example, each RFID tag 201b may store a unique identifier of the syringe 201a to which that RFID tag 201b is located. As an example, the identifier may include an electronic product code (EPC).

[0048] The controller system 202 may include one or more devices capable of receiving information and / or data from the RFID reader 204, trigger sensor 206, conveying system 208, and / or database system 211 (e.g., via a communication network, via a direct wired connection, and / or a wireless connection), and / or transmitting information and / or data to the RFID reader 204, trigger sensor 206, conveying system 208, and / or database system 211 (e.g., via a communication network, via a direct wired connection, and / or a wireless connection). For example, the controller system 202 may include computing devices, such as a server, a group of servers, and / or other similar devices. In some non-limiting embodiments or aspects, the controller system 202 may include middleware (e.g., based on the Message Queuing Telemetry Transport (MQTT) protocol and / or the like) configured to manage communication with and / or control of RFID readers 204, trigger sensors 206, conveying systems 208 (e.g., a programmable logic controller (PLC) of the conveying system 208), and / or database systems 211.

[0049] The RFID reader 204 may include one or more devices that are capable of receiving information and / or data from the controller system 202, the trigger sensor 206, the conveying system 208, and / or the database system 211 (e.g., via a communication network, via a direct wired connection, and / or a wireless connection), and / or transmitting information and / or data to the controller system 202, the trigger sensor 206, the conveying system 208, and / or the database system 211 (e.g., via a communication network, via a direct wired connection, and / or a wireless connection).

[0050] RFID reader 204 may include a passive RFID reader, an active RFID reader, or any combination thereof. RFID reader 204 may be configured to read identifiers associated with syringes 201a from multiple RFID tags 201b on needle guards 201c of multiple syringes 201a in a production line. For example, RFID reader 204 may be configured to attempt to read RFID tags 201b on syringes 201a in response to receiving a trigger signal from trigger sensor 206.

[0051] The RFID coupling element 205 of the RFID reader 204 (which may be configured as a near-field antenna or other near-field coupling element, but is generally referred to as "antenna 205" below) may be located near the conveyor 209 such that as the conveyor 209 moves multiple syringes 201a in the production line, multiple medical devices are moved one after another to the vicinity of the antenna 205 of the RFID reader 204 at the "reading position" (and / or paused nearby for a predetermined period of time), and then moved past the antenna 205 of the RFID reader 204. For example, the spacing between the multiple syringes 201a in the production line on the conveyor 209 and / or the magnitude of the magnetic field or electromagnetic field generated by the RFID reader 204 from the antenna 205 may be configured such that at any given time, only a single syringe among the multiple syringes 201a is located in the magnetic field or electromagnetic field generated by the RFID reader 204 from the antenna 205 (e.g., such that at any given time, only a single syringe among the multiple syringes 201a can be read by the RFID reader 204—i.e., "single read"). In some embodiments, when the corresponding syringe 201a passes the reading position, the antenna 205 can be placed at a distance of 1 mm to 20 mm from the RFID tag 201b.

[0052] The trigger sensor 206 may include one or more devices that are capable of receiving information and / or data from the controller system 202, RFID reader 204, conveying system 208 and / or database system 211 (e.g., via a communication network, via a direct wired connection and / or a wireless connection), and / or transmitting information and / or data to the controller system 202, RFID reader 204, conveying system 208 and / or database system 211 (e.g., via a communication network, via a direct wired connection and / or a wireless connection).

[0053] Trigger sensor 206 may include at least one sensor (e.g., an optical sensor, a laser sensor, etc.) configured to detect or be triggered when an individual syringe is located at a predetermined position relative to the antenna 205 of RFID reader 204 (e.g., when the syringe is located at a reading position adjacent to the antenna 205). Trigger sensor 206 may be located near or adjacent to the antenna 205 and / or conveyor 209 of RFID reader 204, and / or at a position relative to the antenna 205 and / or conveyor 209 of RFID reader 204 such that, at this position, when the syringe is located at the predetermined position relative to the antenna 205 of RFID reader 204, the syringe is within the detection field or field of view of trigger sensor 206, causing trigger sensor 206 to be triggered or to detect the syringe. Trigger sensor 206 may be configured to transmit or send a trigger signal to RFID reader 204 in response to being triggered or detecting the syringe at the predetermined position relative to the antenna 205 of RFID reader 204, to trigger or cause RFID reader 204 to attempt to read the RFID tag on the syringe.

[0054] The conveying system 208 may include one or more devices that are capable of receiving information and / or data from the controller system 202, RFID reader 204, trigger sensor 206 and / or database system 211 (e.g., via a communication network, via a direct wired connection and / or wireless connection), and / or transmitting information and / or data to the controller system 202, RFID reader 204, trigger sensor 206 and / or database system 211 (e.g., via a communication network, via a direct wired connection and / or wireless connection).

[0055] The conveying system 208 may include a conveyor 209 (e.g., an electric belt conveyor, electric chute conveyor, electric roller conveyor, electric overhead conveyor, electric bucket conveyor, electric chain conveyor, electric trolley conveyor, etc.) that conveys the syringes 201a along a linear or circular path. Each of the plurality of syringes 201a may be held by a holding or clamping device of the conveyor 209, wherein the syringe 201a is held in place by mechanical force, suction, or other suitable means. The conveyor 209 may be configured to move the syringes 201a individually in the production line (e.g., one after another, etc.), bringing them close to and past the antenna 205 of the RFID reader 204. For example, syringes 201a may be arranged on conveyor 209, and / or conveyor 209 may be configured to move multiple syringes 201a together in the same direction, such that syringes 201a are moved one after another to the vicinity of antenna 205 of RFID reader 204 (and / or paused nearby for a predetermined period of time), and then moved past antenna 205. As an example, conveyor 209 may include one or more high-throughput production machines and / or components thereof for the pharmaceutical industry, such as machines for filling and finishing processes, machines for automated visual inspection processes, machines for labeling processes, and / or machines for device assembly processes, etc. In some embodiments, the conveyor 209 can be operated to provide a high throughput for reading / testing the syringes 201a, wherein the conveyor 209 operates at a certain speed and wherein the syringes have a certain pitch / gap such that the syringes are conveyed through the antenna 205 at a reading rate between 100 pieces / second and 6000 pieces / minute (e.g., 1000 pieces / minute as a non-limiting example)—this reading rate can be achieved by the conveyor 209 pushing the syringes 201a with a pitch of about 19 mm at a speed of about 1 m / s.

[0056] Conveyor 209 may include ejection mechanism 210 configured to remove (e.g., eject from) individual syringes 201a from conveyor 209 and / or production line. For example, ejection mechanism 210 may include a blower, pneumatic actuator, overhead cleaner, pneumatic traction device and / or down / up pivoting and linearly actuated ejector, etc.

[0057] In some non-limiting embodiments or aspects, the conveying system 208 includes a programmable logic controller (PLC) configured to control one or more operations of the conveyor 209. The PLC may be configured to track the sequential order of a plurality of syringes 201a on the production line and / or conveyor 209 using one or more shift registers and / or sensors, according to existing manufacturing techniques. The PLC may be configured to remove or eject individual syringes from the production line using the tracked sequence order in response to a ejection signal received from the controller system 202, as described in more detail below.

[0058] Database system 211 may include one or more devices capable of receiving information and / or data from controller system 202, RFID reader 204, trigger sensor 206, and / or delivery system 208 (e.g., via a communication network, via a direct wired connection, and / or a wireless connection), and / or transmitting information and / or data to controller system 202, RFID reader 204, trigger sensor 206, and / or delivery system 208 (e.g., via a communication network, via a direct wired connection, and / or a wireless connection). In some non-limiting embodiments or aspects, database system 211 includes one or more local databases (e.g., locally deployed and / or implemented by controller system 202). In other non-limiting embodiments or aspects, database system 211 includes one or more external databases (e.g., external to controller system 202 and / or not implemented by controller system 202). Database system 211 can be configured to store data about the interaction between RFID reader 204 (and antenna 205) and RFID tag 201b of syringe 201a—including the minimum power required for RFID tag 201b to provide a backscattered signal, i.e., the minimum transmit power or carrier signal strength from RFID reader 204 (and antenna 205) required to read RFID tag 201b, as explained in further detail below.

[0059] Figure 2 The number and arrangement of the devices shown are provided as an example. Figure 2 Compared to the illustrated device, there can be more devices, fewer devices, different devices, or devices with different arrangements. Furthermore, Figure 2 The two or more devices shown can be implemented in a single device, or Figure 2 The single device shown can be implemented as multiple distributed devices. Additionally or alternatively, a group of devices in system 200 (e.g., one or more devices, etc.) can perform one or more functions described as being performed by another group of devices in system 200.

[0060] Now for reference Figure 3 , Figure 3 This is a schematic diagram of example components of device 300. Device 300 may correspond to one or more devices of controller system 202, RFID reader 204 (e.g., one or more devices of RFID reader 204 system, etc.), trigger sensor 206 (e.g., one or more devices of trigger sensor 206 system, etc.), conveying system 208, and / or database system 211, etc. In some non-limiting embodiments or aspects, one or more devices of controller system 202, RFID reader 204 (e.g., one or more devices of RFID reader 204 system, etc.), trigger sensor 206 (e.g., one or more devices of trigger sensor 206 system, etc.), conveying system 208, and / or database system 211, etc., may include at least one device 300 and / or at least one component of device 300. Figure 3 As shown, the device 300 may include a bus 302, a processor 304, a memory 306, a storage component 308, an input component 310, an output component 312, and a communication interface 314.

[0061] Bus 302 may include components that allow communication between the various components of device 300. In some non-limiting embodiments or aspects, processor 304 may be specifically configured to perform one or more of the described hybrid aspects in hardware, software, or a combination of hardware and software. For example, processor 304 may include a processor (e.g., a central processing unit (CPU), graphics processing unit (GPU), accelerated processing unit (APU), etc.), a microprocessor, a digital signal processor (DSP), and / or similar processing components that can be programmed to perform functions (e.g., a field-programmable gate array (FPGA), application-specific integrated circuit (ASIC), etc.). Memory 306 may include random access memory (RAM), read-only memory (ROM), and / or another type of dynamic or static storage device (e.g., flash memory, magnetic storage, optical storage, etc.) that stores information and / or instructions for use by processor 304.

[0062] Storage component 308 may store information and / or software related to the operation and use of device 300. For example, storage component 308 may include hard disk (e.g., magnetic disk, optical disk, magneto-optical disk, solid-state disk, etc.), compact disc (CD), digital versatile disc (DVD), floppy disk, cartridge, magnetic tape and / or another type of computer-readable medium, and corresponding drives.

[0063] Input component 310 may include components that allow device 300 to receive information, for example, via a user input terminal (e.g., a touchscreen display, keyboard, keypad, mouse, button, switch, microphone, etc.). Additionally or alternatively, input component 310 may include sensors for sensing information (e.g., a global positioning system (GPS) component, accelerometer, gyroscope, actuator, etc.). Output component 312 may include components that provide output information from device 300 (e.g., a display, speaker, one or more light-emitting diodes (LEDs), etc.).

[0064] Communication interface 314 may include transceiver-like components (e.g., a transceiver, a separate receiver, and a transmitter), which enable device 300 to communicate with other devices, for example, via a wired connection, a wireless connection, or a combination of wired and wireless connections. Communication interface 314 may allow device 300 to receive information from another device and / or provide information to another device. For example, communication interface 314 may include an Ethernet interface, an optical interface, a coaxial interface, an infrared interface, a radio frequency (RF) interface, a universal serial bus (USB) interface, a Wi-Fi® interface, and / or a cellular network interface.

[0065] Apparatus 300 can perform one or more processes described herein. Apparatus 300 can execute these processes based on software instructions stored in a computer-readable medium such as memory 306 and / or storage unit 308, executed by a processor 304 (e.g., a central processing unit (CPU), graphics processing unit (GPU), etc.). Computer-readable media (e.g., non-transitory computer-readable media) are defined herein as non-transitory storage devices. Non-transitory storage devices include storage space located within a single physical storage device or storage space distributed across multiple physical storage devices.

[0066] Software instructions may be read into memory 306 and / or storage unit 308 from another computer-readable medium or another device via communication interface 314. When the software instructions stored in memory 306 and / or storage unit 308 are executed, they may cause processor 304 to perform one or more processes described herein. Additionally or alternatively, hard-wired circuitry may be used in place of or in conjunction with software instructions to perform one or more processes described herein.

[0067] The memory 306 and / or storage component 308 may include a data storage device or one or more data structures (e.g., a database). The device 300 is capable of receiving information from the data storage device or one or more data structures in the memory 306 and / or storage component 308, storing information therein, transmitting information thereto, or searching for information stored therein.

[0068] Figure 3 The number and arrangement of components shown are provided as examples. In some non-limiting embodiments or aspects, with Figure 3 Compared to the components shown, device 300 may include more components, fewer components, different components, or components arranged differently. Additionally or alternatively, a group of components of device 300 (e.g., one or more components) may perform one or more functions described as being performed by another group of components of device 300.

[0069] According to aspects of this disclosure, it should be recognized that reading the RFID tag 201b of the syringe 201a via the RFID reader 204 can be used as part of a quality control inspection of the syringe 201a. Specifically, reading the RFID tag 201b of the syringe 201a can be used to detect leakage in the syringe 201a due to puncture of its needle guard 201c, which may occur, for example, due to puncture of the needle guard 201c relative to the needle (e.g., Figure 1B Misalignment of the needle 124 in the syringe causes the needle to puncture the needle guard 201c (i.e., puncture the inner sleeve of the needle guard), and thus, when the needle is not properly held within the needle guard 201c (i.e., not properly inserted / contained within the inner sleeve of the needle guard), fluid from the tip of the needle can leak out. The sensitivity of the RFID tag 201b in each syringe 201a can be determined in order to indirectly detect whether the syringe 201a may have a punctured needle guard condition—since it has been determined that the sensitivity of the RFID tag is affected by the condition of the needle guard 201c, where such effect depends on the RFID tag that may be damaged due to needle misalignment / puncture.

[0070] Now for reference Figure 4The document provides a flowchart of a non-limiting embodiment or aspect of a method 400 for performing a single reading and testing of syringes on a high-throughput conveyor (e.g., 1000 syringes / minute). Specifically, method 400 reads the RFID tag of each syringe as part of a quality control check that detects leakage in the syringe due to puncture of its needle sheath.

[0071] In some non-limiting embodiments or aspects, one or more steps of process 400 may be performed by controller system 202 (e.g., one or more devices of controller system 202, etc.) (e.g., entirely, partially, etc.). In some non-limiting embodiments or aspects, one or more steps of process 400 may be performed by another device or another set of devices separate from or including controller system 202 (e.g., entirely, partially, etc.), such as RFID reader 204 (e.g., one or more devices of RFID reader 204, etc.), trigger sensor 206 (e.g., one or more devices of trigger sensor 206, etc.), conveying system 208 (e.g., one or more devices of conveying system 208, etc.) and / or database system 211 (one or more devices of database system 211, etc.).

[0072] like Figure 4 As shown, in step 402, process 400 includes: determining acceptance criteria regarding what constitutes a qualified syringe 201a and a non-qualified syringe 201a in terms of the condition of the needle guard 201c of the syringe—that is, an intact (unpunctured) needle guard 201c versus a punctured needle guard 201c. As described above, the sensitivity of the RFID tag 201b in each syringe 201a can be used to detect whether the syringe may have a punctured needle guard condition. Therefore, according to embodiments of this disclosure, acceptance criteria constituting a qualified syringe 201a conforming to product specifications can be determined by identifying the sensitivity (or sensitivity range) (i.e., normal tag sensitivity range) of the RFID tag 201b known to be included in a qualified syringe 201a—where such RFID tag sensitivity is related to the minimum power required for the RFID tag 201b to provide a backscattered signal (i.e., the minimum transmit power or carrier signal strength from the RFID reader 204 (and antenna 205) required to read the RFID tag 201b).

[0073] According to one aspect of this disclosure, determining the acceptance criteria in step 402 can be performed by accessing stored data regarding established acceptance criteria (e.g., stored in the memory of database system 211 or controller 202). The stored data regarding the acceptance criteria may include readings of the minimum transmit power or carrier signal strength generated from RFID reader 204 (and antenna 205) required to read the RFID tag 201b of a known qualified syringe 201a (with a complete / unpierced needle sheath 201c). The data stored in database system 211 may have been obtained from previous runs of the syringe 201a on delivery system 208, and / or from separate, independent tests of the syringe 201a when analyzing RFID tag sensitivity. According to another aspect of this disclosure, determining the acceptance criteria in step 402 can be performed by performing an initial test run of the syringe 201a on delivery system 208 using a syringe 201a known to meet product specifications (i.e., with a complete / unpierced needle sheath 201c). Data can be obtained from tests performed on the minimum transmit power or carrier signal strength required from the RFID reader 204 (and antenna 205) to read the RFID tag 201b of the syringe 201a in order to establish acceptance criteria, and then the data is stored in the database system 211.

[0074] According to embodiments of this disclosure, for a known qualified syringe 201a (with a complete / unpierced needle sheath 201c), the minimum carrier signal strength required to read its RFID tag 201b (i.e., to generate a backscattered signal from the RFID tag) can be set as a reference carrier power threshold. Multiple different RFID reader settings or frequencies can be derived for the reference carrier power threshold, thereby defining a carrier power versus frequency curve for the reference carrier power threshold. As a non-limiting example of a reference carrier power threshold that can be defined for a known qualified syringe 201a, the reference carrier power threshold could be -1.5 dBm for 865 MHz, -5.5 dBm for 915 MHz, and -1.5 dBm for 960 MHz. It should be appreciated that other reference carrier power thresholds can be set, such as those determined based on test results from known qualified syringes 201a.

[0075] like Figure 4As shown, when the acceptance criteria (i.e., the reference carrier power threshold) are defined in step 402, process 400 continues in step 404, where the conveyor is controlled to start the syringe production line. For example, controller system 202 can control conveyor system 208 to start a production line including multiple syringes 201a, for example, to cause conveyor system 209 to begin conveying motion to move the multiple syringes 201a in the production line near and past the antenna 205 of RFID reader 204, i.e., to the reading position. As an example, controller system 202 (e.g., middleware of controller system 202, etc.) can send a signal to conveyor system 208 (e.g., PLC of conveyor system 208, etc.) to cause conveyor system 208 to control conveyor 209 to begin conveying motion. In such an example, controller system 202 (e.g., middleware of controller system 202, etc.) can send a signal to the RFID reader to cause RFID reader 204 to enter a standby state.

[0076] like Figure 4 As shown, in step 406, process 400 includes detecting the syringe at a predetermined position relative to the antenna of the RFID reader. For example, for each of a plurality of syringes 201a in a production line, trigger sensor 206 can detect when the syringe is at a predetermined position relative to the antenna 205 of the RFID reader 204 (i.e., at the reading position).

[0077] like Figure 4 As shown, in step 408, process 400 includes sending a trigger signal to an RFID reader. For example, for each of a plurality of syringes 201a in a production line, trigger sensor 206 may send a trigger signal to the RFID reader in response to detecting that the syringe is located at a predetermined position relative to the antenna 205 of the RFID reader 204 in the production line (i.e., at the reading position) to trigger or cause the RFID reader 204 to read the RFID tags among the plurality of RFID tags 201b on the syringe 201a.

[0078] like Figure 4As shown, in step 410, process 400 includes reading RFID tags on syringes. For example, for each of a plurality of syringes 201a in a production line, RFID reader 204 may read RFID tag 201b on syringe 201a in response to receiving a trigger signal from trigger sensor 206 (e.g., corresponding to the syringe, etc.). As an example, RFID reader 204 may transmit radio waves to RFID tag 201b via antenna 205, wherein the radio waves have a carrier power sufficient to activate the RFID tag. RFID tag 201b may, in response to receiving the radio waves, send a signal including an identifier associated with the syringe back to antenna 205 for reading by RFID reader 204. As an example, (e.g., when a plurality of syringes 201a in a production line are individually moved to the vicinity of antenna 205 of RFID reader 204 by conveyor 209, etc.) RFID reader 204 may read multiple identifiers (e.g., multiple EPCs, etc.) associated with the plurality of syringes 201a from multiple RFID tags 201b on the plurality of syringes 201a in the production line. In such an example, for each of the multiple syringes 201a in the production line, the RFID reader 204 can send or stream information or data (e.g., identifiers, etc.) read from the RFID tag to the controller system 202 (e.g., middleware of the controller system 202).

[0079] In addition to sending information or data (e.g., identifiers, etc.) read from the RFID tags to the controller system 202, the RFID reader 204 also records information or data about the sensitivity of each RFID tag 201b among those being read and sends this information or data to the controller system 202. As previously mentioned, the RFID tag sensitivity can be measured / determined by the minimum carrier power (radio waves / signals emitted from antenna 205 to each RFID tag 201b) required to generate a backscattered signal response from each RFID tag 201b. Therefore, for each of the multiple syringes 201a in the production line, the RFID reader 204 can send or stream the minimum carrier power required to read the RFID tag 201b of that syringe to the controller system 202 (e.g., to middleware of the controller system 202, etc.).

[0080] like Figure 4As shown, in step 412, process 400 includes determining whether the sensitivity of the RFID tag on each syringe being read falls within a normal or acceptable tag sensitivity range. For example, for the RFID tag 201b read by the RFID reader 204 for each of the multiple syringes 201a in the production line, the controller 202 may determine whether the sensitivity of the RFID tag 201b falls within a normal tag sensitivity range. In making this determination, the controller 202 may compare the carrier power required to read the RFID tag 201b for each RFID tag 201b with a predefined reference carrier power threshold, which indicates the minimum carrier power required to read the RFID tag in a qualified syringe 201a (i.e., with an intact / unpierced needle sheath 201c), for example, as determined / retrieved in step 402. In some non-limiting embodiments or aspects, for each RFID tag 201b read by RFID reader 204, controller system 202 (e.g., middleware of controller system 202, etc.) can immediately query database system 211, which includes stored predefined reference carrier power thresholds, to compare the carrier power required to read each RFID tag 201b with the reference carrier power thresholds.

[0081] If the carrier power required to read the corresponding RFID tag 201b is determined to be greater than a reference carrier power threshold (or outside an acceptable standard), process 400 continues in step 414, whereby the corresponding syringe 201a containing the RFID tag 201b is identified as having a pierced needle guard 201c. That is, if the carrier power required to read the corresponding RFID tag is determined to be greater than the reference carrier power threshold, the sensitivity of the RFID tag is considered to be outside the normal RFID tag sensitivity range, indicating that the needle of the syringe 201a has pierced the needle guard 201c, thereby affecting the sensitivity of the RFID tag 201b attached to the needle guard 201c.

[0082] like Figure 4As shown, after syringe 201a is identified as having a punctured needle guard in step 414, process 400 continues in step 416. In step 416, in response to identifying the syringe as having a punctured needle guard, the control conveyor removes the syringe from the production line. For example, controller system 202 (e.g., middleware of controller system 202, etc.) may control conveyor 209 to remove at least one syringe 201a from the production line in response to identifying syringe 201a as having a punctured needle guard (e.g., via conveyor system 208, via the PLC of conveyor system 208, etc.). As an example, for each of the multiple syringes 201a in the production line, the controller system 202 (e.g., middleware of the controller system 202, etc.) may, in response to receiving an indication that the syringe 201a has a punctured needle guard and is considered unqualified, send a signal to the conveyor system 208 (e.g., the PLC of the conveyor system 208, etc.) causing the conveyor system 208 to control the conveyor 209 to remove the syringe from the production line (e.g., the PLC of the conveyor system 208 may control the ejector mechanism 210 to remove / eject the syringe from the production line).

[0083] Returning to step 412, if the carrier power required to read the corresponding RFID tag is determined to be equal to or less than the reference carrier power threshold (or within an acceptable range), then process 400 continues in step 418, whereby the corresponding syringe 201a, including the RFID tag 201b, is identified as having a complete (unpierced) needle shield.

[0084] like Figure 4 As shown, after syringe 201a is identified as having a complete (unpierced) needle sheath in step 418, process 400 continues in step 420. In step 420, in response to identifying the syringe as having a complete (unpierced) needle sheath, the control conveyor holds the syringe on the production line. For example, in response to identifying syringe 201a as having a complete (unpierced) needle sheath 201c, controller system 202 (e.g., middleware of controller system 202, etc.) may, in response to determining that syringe 201a meets acceptance criteria and product specifications, control conveyor 209 to hold syringe 201a on the production line.

[0085] Advantageously, embodiments of the present invention therefore provide a system and method for RFID-tagged needle sheath puncture and leakage detection in RFID-tagged medical injection devices. The method for detecting punctured needle sheath leakage can be performed on a high-speed throughput system (i.e., a delivery system). The sensitivity of the RFID tag in each injection device, read by an RFID reader, can be determined to indirectly detect whether the injection device may have a punctured needle sheath condition, based on the change in RFID tag sensitivity caused by needle sheath puncture. This system and method can be used as a supplement to conventional control systems for leakage detection (e.g., HVLD or visual inspection systems) to improve the accuracy of punctured needle sheath detection, or as an alternative to HVLD or visual inspection systems in environments / situations where their use is not feasible.

[0086] Although this disclosure has been described in detail based on embodiments or aspects currently considered most practical and preferred for illustrative purposes, it should be understood that such details are for that purpose only, and that this disclosure is not limited to the disclosed embodiments or aspects, but rather that such details are intended to cover modifications and equivalent arrangements thereof 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 system for detecting puncture of a needle guard in a medical injection device with multiple RFID tags, each of the RFID-tagged medical injection devices having a needle guard in which an RFID tag is integrated, the system comprising: A delivery system configured to deliver the plurality of RFID-tagged medical injection devices along a delivery path; An RFID coupling element, the RFID coupling element being positioned at a reading location along the transport path; An RFID reader, operably connected to the RFID coupling element, and configured to selectively perform a single read of the RFID tag of the RFID-tagged medical injection device as each corresponding RFID-tagged medical injection device passes the RFID coupling element at the reading location; as well as At least one processor, said at least one processor being coupled to memory, and configured to: For each RFID tag read by the RFID reader, record the carrier power required to generate a backscattered signal response from the RFID tag in the signal sent from the RFID coupling element to the RFID tag; The carrier power provided to each corresponding RFID tag is compared with a specified reference carrier power threshold; and If the carrier power supplied to the corresponding RFID tag read by the RFID reader is greater than the reference carrier power threshold, the medical injection device with the corresponding RFID tag is identified as having a punctured needle shield.

2. The system according to claim 1, wherein, The reference carrier power threshold includes the minimum carrier power required to generate a backscattered signal from the RFID tag for a medical injection device with an RFID tag having a full needle shield.

3. The system according to claim 1, wherein, The reference carrier power threshold includes a carrier power curve against frequency.

4. The system according to claim 1, wherein, The reference carrier power threshold is -1.5 dBm for 865 MHz, -5.5 dBm for 915 MHz, and -1.5 dBm for 960 MHz.

5. The system according to claim 1, wherein, The at least one processor is further configured to determine the reference carrier power threshold based on multiple reference readings obtained from a medical injection device with multiple RFID tags having a full needle shield, the reference readings being the carrier power required to generate a backscatter signal response from the RFID tag of the RFID-tagged medical injection device.

6. The system of claim 1, further comprising at least one trigger sensor configured to detect when a medical injection device with an individual RFID tag is located at the reading position; in, For each of the plurality of RFID-tagged medical injection devices on the delivery system, the at least one sensor is configured to send a trigger signal to the RFID reader in response to detecting that the corresponding RFID-tagged medical injection device is located at the reading position, so that the RFID reader reads the RFID tag of the RFID-tagged medical injection device. and The RFID reader is configured to read the RFID tag on a medical injection device in response to receiving the trigger signal from the at least one sensor.

7. The system according to claim 1, wherein, The at least one processor is further configured to: in response to identifying a medical injection device with a corresponding RFID tag having a punctured needle guard, control the delivery system to eject the RFID-tagged medical injection device from the delivery system.

8. The system according to claim 1, wherein, The medical injection device with multiple RFID tags includes multiple syringes.

9. The system according to claim 1, wherein, The RFID coupling element includes a near-field coupling element, which is placed 1 mm to 20 mm away from the RFID tag when the medical injection device with the corresponding RFID tag passes the reading position.

10. The system according to claim 1, wherein, The conveying system is configured to transport the multiple RFID-tagged medical devices past the reading location at a rate of up to 1000 pieces / minute.

11. A method for detecting puncture of a needle guard in a medical injection device with multiple RFID tags, each of the RFID-tagged needle guards having an integrated RFID tag in the needle guard, the method comprising: Each of a plurality of RFID-tagged medical devices is transported along a transport path by a transport system, the plurality of RFID-tagged medical devices comprising an RFID tag integrated with its needle sheath. An RFID reading system is installed at a location along the conveying path, the RFID reading system comprising: An RFID coupling element, the RFID coupling element being positioned at a reading location along the transport path; and An RFID reader, which is operatively connected to the RFID coupling element; When each of the multiple RFID-tagged medical devices passes the reading location, the RFID reading system performs a single reading of the corresponding RFID-tagged medical device; and Based on the reading of each RFID-tagged medical device among the plurality of RFID-tagged medical devices, a potential needle shield puncture in each corresponding RFID-tagged medical injection device is identified by at least one processor. The method for identifying potential needle shield puncture includes: For each RFID tag, record the carrier power required to generate a backscattered signal response from the RFID tag in relation to the signal transmitted from the RFID coupling element to the RFID tag; The carrier power provided to each corresponding RFID tag is compared with a specified reference carrier power threshold; and If the carrier power supplied to the corresponding RFID tag read by the RFID reader is greater than the reference carrier power threshold, the medical injection device with the corresponding RFID tag is identified as having a punctured needle shield.

12. The method according to claim 11, wherein, The reference carrier power threshold includes the minimum carrier power required to generate a backscattered signal from the RFID tag for a medical injection device with an RFID tag having a full needle shield.

13. The method of claim 11, further comprising: In response to the identification of a medical injection device with a corresponding RFID tag as having a punctured needle guard, the delivery system is controlled to eject the RFID-tagged medical injection device from the delivery system.

14. The method of claim 11, further comprising: A medical injection device with an individual RFID tag is used to detect when it is located at the reading position; as well as In response to the detection that a medical injection device with the RFID tag is located at the reading position, a trigger signal is sent from the at least one trigger sensor to the RFID reader, so that the RFID reader reads the RFID tag of the medical injection device with the corresponding RFID tag.

15. The method of claim 11, further comprising: The RFID coupling element is positioned at the reading position such that when a medical injection device with a corresponding RFID tag passes the reading position, the RFID coupling element is placed at a distance of 1 mm to 20 mm from the RFID tag.

16. A system for detecting puncture of a needle guard in a medical injection device with multiple RFID tags, each of the RFID-tagged medical injection devices having a needle guard in which an RFID tag is integrated, the system comprising: A delivery system configured to deliver the plurality of RFID-tagged medical injection devices along a delivery path; An RFID coupling element, the RFID coupling element being positioned at a reading location along the transport path; An RFID reader, operably connected to the RFID coupling element, and configured to selectively perform a single read of the RFID tag of the RFID-tagged medical injection device as each corresponding RFID-tagged medical injection device passes the RFID coupling element at the reading location; as well as At least one processor, said at least one processor being coupled to memory, and configured to: Determine the tag sensitivity of the RFID tag of the medical injection device for each of the multiple RFID tags read by the RFID reader; The tag sensitivity of each RFID tag is compared with a predetermined normal tag sensitivity range; and If the tag sensitivity of the corresponding RFID tag is outside the normal tag sensitivity range, then the medical injection device with the corresponding RFID tag is identified as having a punctured needle shield.

17. The system according to claim 16, wherein, The at least one processor is further configured to determine the normal tag sensitivity range based on multiple reference readings obtained from a medical injection device with multiple RFID tags having a full needle shield.

18. The system according to claim 16, wherein, When determining the tag sensitivity, the at least one processor is configured to: for each RFID tag read by the RFID reader, record the carrier power required to generate a backscatter signal response from the RFID tag, which is transmitted from the RFID coupling element to the RFID tag; and wherein, when comparing the tag sensitivity of each RFID tag with a predetermined normal tag sensitivity range, the at least one processor is configured to: compare the carrier power with a specified reference carrier power threshold, wherein when the recorded carrier power of the corresponding RFID tag read by the RFID reader is greater than the reference carrier power threshold, the medical injection device of the corresponding RFID tag is identified as having a punctured needle sheath.

19. The system according to claim 16, wherein, The at least one processor is further configured to: in response to identifying a medical injection device with a corresponding RFID tag having a punctured needle guard, control the delivery system to eject the RFID-tagged medical injection device from the delivery system.

20. The system of claim 16, wherein, The RFID coupling element includes a near-field coupling element, which is placed 1 mm to 20 mm away from the RFID tag when the medical injection device with the corresponding RFID tag passes the reading position.

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