Needle cover for medical injection devices

Abstract

1. A needle cover for protecting a needle attached to a tip of a medical injection device, the tip extending from a distal end of the medical injection device, the needle cover comprising an inner shield extending along a longitudinal axis and an outer shield at least partially surrounding the inner shield and operably coupled to the inner shield, wherein when the needle cover is positioned on the tip of the medical injection device, a proximal surface of the inner shield contacts the distal end of the tip of the medical injection device.

Description

Technical Field

[0001] Cross-Reference to Related Applications This application claims the priority of European Application No. 21305525.4 entitled "Needle Cover for Medical Injection Device" filed on April 21, 2021, the entire disclosure of which is incorporated herein by reference. The present disclosure relates generally to medical injection devices for delivering fluids or liquid medicaments. More specifically, the present disclosure relates to a needle cover adapted to be attached to the distal end of a medical injection device for covering a needle mounted on the medical injection device. The present disclosure also relates to a medical assembly comprising a medical injection device and a needle cover enclosing the needle of the medical injection device. Background Art

[0002] Medical injection devices such as syringes are well known in the art. These devices typically comprise a container for containing a medical composition such as a liquid medicament. The container usually includes a distal end portion in the form of a longitudinally directed tip that defines a fluid path through which the medical solution is discharged. A needle may be attached to the tip to pierce the patient's skin and perform the injection of the medical composition.

[0003] To maintain sterility before use and reduce the risk of accidental needle stick injuries, needle protection is crucial. Therefore, a needle cover may be attached to the tip of the barrel so as to surround the needle. This prevents physical access to the needle by anyone near the device. The needle cover may comprise an inner shield made of an elastomerous material, and an outer shield made of rigid plastic surrounding the inner shield. In some examples, the inner shield may be made of rubber. The inner shield ensures the sealing of the medical injection device. Therefore, the inner shield provides a sealing portion that makes airtight contact with the outer surface of the syringe tip. The inner shield prevents contamination of the medical composition from the external environment, thereby ensuring complete airtightness of the container. Furthermore, the inner shield prevents the composition from leaking into the external environment through the needle exit. Therefore, it is preferable that the needle is inserted into the inner shield. The rigid outer shield may consist of a rigid or semi-rigid material surrounding the inner shield.

[0004] The inner shield creates an interfering force with the tip of the medical syringe, ensuring a complete seal of the fluid inside. In some cases, the complete seal of the opening of the medical syringe is achieved by radial compression of the inner shield at the tip of the medical syringe. This radial compression at the tip of the medical syringe is increased below the tip by the use of a rigid outer shield, preventing the needle cover from unintentionally detaching from the medical syringe. Many of these features of the needle cover also affect the amount of force required to remove the needle cover from the medical syringe.

[0005] When designing a needle cover, several characteristics that affect its performance level must be considered. In particular, these characteristics include the complete sealing of the container at the tip of the medical syringe, the prevention of unintended detachment of the needle cover from the medical syringe, and the ability to remove the needle cover from the medical syringe with moderate force. Because these characteristics of a needle cover often influence three different properties, it is often difficult to adjust the performance level of each individual characteristic without affecting the performance level of the remaining characteristics. [Overview of the project]

[0006] In light of the above problems, there is a need for needle covers that improve the complete sealing of the container at the tip of a medical injection device, reduce the possibility of the needle cover unintentionally coming off the medical injection device, and reduce the amount of force required to remove the needle cover from the medical injection device. There is also a need for needle covers that enable tracking of medical devices fitted with the needle cover from the manufacturing or assembly stage to final use. Furthermore, there is a need to provide devices and needle covers that enable individual identification of medical injection devices. In addition, it is necessary to confirm that a medical injection device contains the desired pharmaceutical composition and that it is not filled with a pharmaceutical composition other than the intended one. It is also necessary to confirm that a medical injection device has not been opened before use. Therefore, it is desirable to provide such medical injection devices with means to detect tampering.

[0007] One example of the present disclosure is a needle cover for protecting a needle attached to the tip of a medical injection device, wherein the tip extends from the distal end of the medical injection device, and the needle cover comprises an inner shield extending along a longitudinal axis and an outer shield at least partially surrounding the inner shield and operably coupled to the inner shield, wherein when the needle cover is positioned on the tip of the medical injection device, the proximal surface of the inner shield contacts the distal end of the tip of the medical injection device, and can cause longitudinal axial compression at the distal end of the tip of the medical injection device.

[0008] In one example of this disclosure, the proximal surface of the inner shield may contact the most distal surface of the distal end of the tip of the medical injector. The inner shield may cause axial compression at the distal end of the tip of the medical injector and reduce radial compression at the distal end of the tip of the medical injector. The proximal surface of the inner shield may contact the most distal surface of the distal end of the tip of the medical injector. The inner shield may be made of a deformable material. The inner shield may be configured to receive at least a portion of the needle. The outer shield may include at least one hook to assist in removing the inner shield from the tip of the medical injector when the needle cover is removed from the medical injector. The at least one hook may include three or four hooks formed on the outer shield. The at least one hook may be made of a flexible material that allows the at least one hook to bend under pressure. The at least one hook may be inclined inward with respect to the longitudinal axis of the inner shield and distally with respect to the proximal portion of the tip of the medical injection device. The at least one hook may be configured to contact a shoulder defined on the tip of the medical injection device when the needle cover is positioned on the tip of the medical injection device. The at least one hook may be positioned at the distal end of the outer shield. The at least one hook may be configured to slide along the outer surface of the tip when the needle cover is removed from the tip of the medical injection device, thereby assisting in the removal of the inner shield from the tip.

[0009] One example of the present disclosure is a needle cover for protecting a needle attached to the tip of a medical injection device, wherein the tip extends from the distal end of the medical injection device, and the needle cover comprises an inner shield extending along a longitudinal axis and an outer shield at least partially surrounding the inner shield and operably coupled to the inner shield, and further comprises a tamper-evident ring for identifying whether the needle cover has been removed from the tip of the medical injection device.

[0010] In one example of the present disclosure, the tampering ring may include at least one of a Bluetooth tag, a radio frequency identification (RFID) tag, an ultra-wideband real-time location system (RTLS), a Wi-Fi RTLS, and an infrared RTLS. The RFID tag may be overmolded onto the tampering ring. The tampering ring includes a lower and an upper section, each of which may include an antenna section. A conductive bridge may be provided between the antenna sections of the lower and upper sections of the tampering ring. The tampering ring may include a bridge that establishes a breakable bond between the tampering ring and the medical injection device.

[0011] One example of the present disclosure is a medical injection device having a barrel extending from a proximal surface to a distal surface, wherein the tip is provided on the distal surface of the barrel, the medical injection device includes a needle cover for protecting a needle attached to the tip of the medical injection device, the needle cover comprising an inner shield extending along a longitudinal axis and an outer shield at least partially surrounding the inner shield and operably coupled to the inner shield, wherein when the needle cover is positioned on the tip of the medical injection device, the proximal surface of the inner shield contacts the distal end of the tip of the medical injection device, causing axial compression at the distal end of the tip of the medical injection device.

[0012] One example of the present disclosure is a medical injection device having a barrel extending from a proximal to a distal surface, the tip of which is provided on the distal surface of the barrel, the medical injection device comprising a needle cover for protecting a needle attached to the tip of the medical injection device, the needle cover comprising an inner shield extending along a longitudinal axis and an outer shield at least partially surrounding the inner shield and operably coupled to the inner shield, the outer shield comprising at least one hook for assisting in removing the inner shield from the tip of the medical injection device when the needle cover is removed from the medical injection device. One example of the present disclosure is a medical injection device having a barrel extending from a proximal to a distal surface, the tip of which is provided on the distal surface of the barrel, the medical injection device comprising a needle cover for protecting a needle attached to the tip of the medical injection device, the needle cover comprising an inner shield extending along a longitudinal axis and an outer shield at least partially surrounding the inner shield and operably coupled to the inner shield, the needle cover further comprising a tampering ring for identifying whether the needle cover has been removed from the tip of the medical injection device. [Brief explanation of the drawing]

[0013] Figure 1 is a perspective view of a medical injection device relating to an example of this disclosure.

[0014] Figure 2 is a cross-sectional view of the medical injection device shown in Figure 1.

[0015] Figure 3 is another cross-sectional view of the medical injection device shown in Figure 1.

[0016] Figure 4 is a cross-sectional view of a needle cover according to an example of this disclosure.

[0017] Figure 5 is a perspective view of a medical injection device relating to an example of this disclosure.

[0018] Figure 6 is a side view of the needle cover and the foul-marking ring shown in Figure 5, when the foul-marking ring is not broken.

[0019] Figure 7 is a side view of the needle cover and the foul-marking ring shown in Figure 5 when the foul-marking ring has fractured.

[0020] Figure 8 is a cross-sectional view of Figure 6 when the fraudulent ring is not fractured.

[0021] Figure 9 is a cross-sectional view of Figure 7 when the tampering ring is fractured. Detailed description of the invention

[0022] The following description will enable those skilled in the art to construct and use the embodiments described below, which have been designed for carrying out the present invention. However, various modifications, equivalents, variations, and substitutions will be readily apparent to those skilled in the art. All such modifications, variations, equivalents, and substitutions are considered to fall within the technical spirit and scope of the present invention.

[0023] In the following description, “up,” “down,” “right,” “left,” “vertical,” “horizontal,” “up,” “down,” “side,” “vertical,” and their derivatives refer to the present invention as oriented in the drawings. However, it should be understood that the present invention may be subject to various alternative modifications unless expressly otherwise specified. Furthermore, it should be understood that the specific devices illustrated in the accompanying drawings and described herein below are exemplary embodiments of the present invention. Accordingly, specific dimensions and other physical characteristics relating to the embodiments disclosed herein should not be considered limiting.

[0024] In the following description, “distal” generally refers to the direction toward the end of a medical injection device adapted to contact the patient’s skin, and “proximal” refers to the direction opposite to distal, i.e., away from the aforementioned end of the medical injection device. In other words, “distal direction” is understood to mean the direction of injection. The distal direction corresponds to the direction of movement of the plunger during injection and the direction in which the medical composition initially contained in the barrel is discharged from the barrel. “Proximal direction” is understood to mean the direction opposite to said injection direction. For the purposes of this disclosure, the above references are used in the description of the components of the medical injection device relating to this disclosure.

[0025] Referring to Figures 1-3, the medical injection device 10 may include a barrel 12 that extends along the longitudinal axis X from a proximal surface 14 to a distal surface 16 and defines a reservoir 18 for a medical composition such as a liquid drug. The medical injection device 10 may also include a stopper (not shown) and a plunger rod (not shown) that is capable of translationally moving from a proximal to a distal position within the barrel 12 for injecting the composition.

[0026] The medical injection device 10 further includes a distal tip portion 20 extending along the longitudinal axis X from the distal surface 16 of the barrel 12. The distal tip portion 20 may be at least partially hollow so as to form a fluid path in fluid communication with the barrel 12. The needle 22 may be attached to the distal tip portion 20 of the medical injection device 10 and placed in fluid communication with the fluid path. It should be noted herein that the distal surface 16 of the barrel 12 is proximate to the shoulder of the medical injection device 10.

[0027] The medical injection device 10 is preferably made of glass, and more preferably is a glass syringe. Such a glass syringe is mainly used in hospital environments and can be easily sterilized. In other examples of the present disclosure, the medical injection device 10 may be made of medical-grade plastic. The medical injection device 10 is preferably a prefilled syringe or a prefillable syringe. The medical injection device 10 is more preferably a syringe provided with a needle 22.

[0028] With continued reference to Figures 1 to 3, the medical injection device 10 may further include a needle cover 100. The needle cover 100 may shield and cover the needle 22. The needle cover 100 may include an outer shield 102 and an inner shield 104 that covers the needle 22. In one embodiment, the outer shield 102 covers at least a portion of the inner shield 104. In another embodiment, the outer shield 102 covers the entire inner shield 104.

[0029] With reference to Figures 2 and 3, the outer shield 102 according to an example of the present disclosure will be described in more detail. The outer shield 102 is preferably made of a rigid material such as rigid plastic. The outer shield 102 may be made of medical-grade plastic. The rigid material imparts rigidity to the outer shield 102, which can better protect the needle cover 100 from impacts. This improves the structural integrity of the needle cover 100.

[0030] The outer shield 102 includes a body 106 having a proximal end 108 and a distal end 110. The body 106 extends along the longitudinal axis Y. The longitudinal axis Y coincides with the longitudinal axis X when the needle cover 100 is attached to the tip 20 of the medical injection device 10.

[0031] In one example, the body 106 may be substantially cylindrical in shape. The body 106 may define an internal cavity 112 that at least partially receives the inner shield 104 of the needle cover 100. A collar 114 may be formed on the proximal end 108 of the outer shield 102. The collar 114 may have a larger diameter than the rest of the body 106. In one example, a plurality of ribs and grooves 116 may be defined on the body 106 of the outer shield 102. The ribs and grooves 116 may be provided adjacent to the distal end 110 of the outer shield 102. The ribs and grooves 116 provide a gripping surface used by the user when pulling the outer shield 102 away from the medical injection device 10. In one embodiment, the distal end 110 of the outer shield 102 may include at least one opening for sterilizing the needle cover 100.

[0032] Referring to Figures 2 and 3, an example of an inner shield 104 according to the present disclosure will be described. The inner shield 104 may extend along the longitudinal axis Z. The longitudinal axis Z may coincide with the longitudinal axis Y when the inner shield 104 is at least partially enclosed within the outer shield 102. The inner shield 104 preferably has a cylindrical shape and a circular cross-section.

[0033] The inner shield 104 is preferably made of a material having elastomer properties. This allows at least a portion of the inner shield 104 to deform slightly to conform to the shape of the tip 20 when it is attached to the medical injection device 10. Meanwhile, the tip 20, or the distal portion of the needle 22, can pass through the inner shield 104. This further reduces the risk of the medical composition leaking into the external environment through the needle 22. The material having elastomer properties is preferably a thermoplastic elastomer, elastomer, or rubber. The material having elastomer properties is preferably sterilizable.

[0034] In one embodiment, the outer shield 102 surrounds the inner shield 104 at least partially. The outer shield 102 is fixed to the inner shield 104. The inner shield 104 and the outer shield 102 can be fixed together by various coupling methods, such as snap-fit ​​coupling or friction fitting. When the needle cover 100 is attached to the medical injection device 10, the inner shield 104 surrounds at least a portion of the tip 20 of the barrel 12. This tightly seals the needle cover 100 to the tip 20. In one embodiment, the inner shield 104 ensures a sterile and fluid-tight seal between the tip 20 of the medical injection device 10 and the inner shield 104 by forming a well-sealed seal with the tip 20 of the medical injection device 10.

[0035] To attach the needle cover 100 to the medical injection device 10, first the outer shield 102 is placed on top of the inner shield 104, and then the entire needle cover 100 is attached to the medical injection device 10. After the needle cover 100 is placed on the medical injection device 10, the needle cover 100 can be removed from the medical injection device 10 by moving it distally. When a pulling force is applied to the outer shield 102 by the user, the outer shield 102 moves distally together with the inner shield 104. As the outer shield 102 moves distally, the proximal end 108 of the outer shield 102 begins to contact and abut against the proximal portion 120 of the inner shield 104. When the proximal end 108 of the outer shield 102 contacts the proximal portion 120 of the inner shield 104, the proximal end 108 begins to push the proximal portion 120 distally. When the proximal portion 120 is pushed distally, the inner shield 104 is pulled radially away from the medical injection device 10.

[0036] Continuing to refer to Figures 2 and 3, according to one example of the present disclosure, the inner shield 104 may be positioned to reduce the radial compressive force applied to the tip 20 of the medical injection device 10. In one example of the present disclosure, instead of gripping the side of the tip 20 of the medical injection device 10, the inner shield 104 is positioned to engage with the most distal surface of the tip 20 of the medical injection device 10. In this configuration, when the needle cover 100 is positioned on the medical injection device 10, the proximal end of the inner shield 104 engages with the most distal surface of the tip 20 of the medical injection device 10 to form a fluid-tight seal to prevent fluid from leaking from the medical injection device 10. In one example of the present disclosure, the inner shield 104 causes longitudinal axial compression at the tip 20 of the medical injection device 10. The inner shield 104 may deform under axial compression to form a seal. In one example of this disclosure, the shoulder extending radially from the tip portion 20 is formed to receive the inner shield 104, thereby causing axial compression in the tip portion 20.

[0037] The inner shield 104 does not engage with the sides of the tip 20 by forming a seal with the distal end of the medical injection device 10, thus preventing variation in the magnitude of the force required to pull the needle cover 100 away from the medical injection device 10. If the inner shield 104 grips the sides of the tip 20, the magnitude of the force required to pull the inner shield 104 away from the tip 20 may vary based on the radial compressive force vector generated on the sides of the tip 20. Therefore, by reducing or eliminating the radial compressive force caused by the inner shield 104 gripping the sides of the tip 20, the magnitude of the force required to pull the needle cover 100 away from the tip 20 becomes more consistent and easier to predict. Alternatively, the magnitude of the force required to pull the needle cover 100 away from the medical injection device 10 is maintained more consistently by creating a secure engagement between the proximal end 108 of the outer shield 102 and the tip 20 of the medical injection device 10. In one example of this disclosure, the proximal end 108 of the outer shield 102 defines at least two openings 122. When the needle cover 100 is positioned on the tip 20, the shoulder 124 formed on the tip 20 can engage with the walls of the openings 122 to form a secure locking engagement. To remove the needle cover 100 from the tip 20, sufficient pulling force is required to pull the openings 122 over the shoulder 124 of the tip 20, thereby separating the needle cover 100 from the tip 20.

[0038] Referring to Figure 4, in one example of this disclosure, the needle cover 100 may also include at least one hook 126 on the rigid outer shield 102 to help more reliably remove the inner shield 104 from the tip 20 of the medical injection device 10. In one example of this disclosure, the rigid outer shield 102 may include two hooks 126. In one example of this disclosure, the rigid outer shield 102 may include four hooks 126. It is also intended that the number of hooks 126 may be increased or decreased and provided on the rigid outer shield 102. The hooks 126 may be inclined inward toward the tip 20 of the medical injection device 10 with respect to the longitudinal axis X of the medical injection device 10. In one example of this disclosure, the hooks 126 may be made of a material that allows the hooks 126 to bend outward as the needle cover 100 slides on the tip 20. In one embodiment, the hooks 126 may be made of the same material as the outer shield 102. The shoulder 124 of the tip 20 can push the hook 126 outward as the needle cover 100 slides on the tip 20. If the hook 126 moves beyond the shoulder 124, it will spring back inward and engage with the cut-off portion of the shoulder 124, preventing the needle cover 100 from detaching from the tip 20. To remove the needle cover 100 from the tip 20, sufficient force is required to pull the hook 126 beyond the shoulder 124 of the tip 20 and to pull the needle cover 100 away from the tip 20. The hook 126 also assists in separating the inner shield 104 from the tip 20 when removing the needle cover 100. If the hook 126 moves distally away from the tip 20, it will be oriented distally along the outer surface of the tip 20. The hook 126 contacts the inner shield 104 held by the tip 20, causing the inner shield 104 to begin to detach from the tip 20, thereby reducing the amount of force required to pull the inner shield 104 away from the tip 20 of the medical injection device 10.

[0039] Referring to Figures 5-9, in one example of this disclosure, the needle cover 200 may also include tamper-evident and device identification features. In one example of this disclosure, if the needle cover 200 is removed from the tip 20 of the medical injection device 10, an indicator of the current state of the medical injection device 10 may be provided indicating whether or not the needle cover 200 has been removed. The indicator of the state of the medical injection device 10 may be a visual indicator, an auditory indicator, or any other method of indicating the current state to a person. As long as the needle cover 200 is not removed from the tip 20 of the medical injection device 10, the needle cover 200 includes a detectable unique device identifier, thereby enabling the tracking of the needle cover 200 from the time the medical injection device 10 is manufactured at the manufacturer's facility until the medical injection device 10 is delivered to a secondary packaging facility and then to its final destination, such as a pharmaceutical research laboratory, hospital, treatment center, or other place where the medical injection device 10 may be used.

[0040] In one example of this disclosure, the needle cover 200 may include a rigid outer shield 202, a deformable inner shield 204, and a tamper-evident ring 206 provided thereon. The tamper-evident ring 206 may include an RFID (radio frequency identification) tag 208. In some examples of this disclosure, the RFID tag 208 may be an ultra-high frequency (UHF) RFID tag. In some embodiments, the tamper-evident ring 206 may include an ultra-wideband real-time location system (RTLS), Wi-Fi RTLS, and / or infrared RTLS. In some examples, the RFID tag may be in the form of a wet-insert, dry-insert, or pressure-sensitive label. The RFID wet-insert and RFID dry-insert may include a substrate made of, for example, paper or polyethylene terephthalate (PET). The RFID tag may be placed on one side of the substrate. Furthermore, the RFID wet-insert and RFID dry-insert may include at least one protective layer on top of the RFID tag. The protective layer may be silicone-treated paper. RFID wet inlay is described as “wet” because it includes an adhesive layer on the opposite side of the substrate and, for example, the backing paper with a silicone liner. RFID dry inlay is described as “dry” because there is no adhesive on the back. Pressure-sensitive labels are similar to high-tech stickers. In one embodiment, the RFID tag is a shortwave radio identification (HF-RFID) tag. The frequency is typically about 1 to 15 MHz. In this embodiment, the RFID reader can read the HF-RFID tag at a distance of, for example, about 1 meter. Preferably, the RFID tag is an ultra-high frequency radio identification (UHF-RFID) tag. The frequency is typically about 400 to 1000 MHz. In this embodiment, the RFID reader can read the UHF-RFID tag at a distance of, for example, about 15 meters.

[0041] The RFID antenna preferably has at least one leg. The RFID antenna may have, for example, two or four legs. More preferably, the RFID antenna has two legs, each having a tip. For example, the RFID antenna has two legs having a plurality of fixing steps. According to the present invention, fixing steps mean that the two legs of the RFID antenna may have a plurality of equal steps. For example, the fixing steps form a square, rectangle, triangle, or waveform. It is preferable that the plurality of fixing steps have the same width. For example, the RFID antenna has two sinusoidal legs, a linear leg, or a coiled leg. If the RFID antenna has two sinusoidal legs, it is preferable that both legs of the RFID antenna are composed of a plurality of sine waves. For example, if the RFID tag is a UHF-RFID tag, the two legs have a sinusoidal shape. For example, if the RFID tag is an HF-RFID tag, the two legs have a coiled shape. In practice, in these embodiments, the shape of the legs is thought to further improve communication between the chip, the RFID tag antenna, and the RFID reader.

[0042] Preferably, the RFID antenna forms a loop between its legs, and the RFID chip is positioned between the loop and legs of the RFID antenna. In one embodiment, the RFID tag is asymmetric, meaning the RFID chip is not positioned equidistant from both ends of the RFID antenna. Preferably, the RFID chip is positioned equidistant from both ends of the RFID antenna.

[0043] In some examples of this disclosure, the tampering ring 206 may consist of polyethylene terephthalate or any other material that allows adhesion to the tampering ring 206. The tampering ring 206 may include, for example, an RFID tag 208 and a first part 210 of an antenna at its lower end. At the top of the tampering ring 206, for example, a second part 212 of an antenna may be positioned within the tampering ring 206. In the middle portion of the tampering ring 206, for example, an electrical bridge 214 may be positioned to connect the first part 210 and the second part 212 of the antenna. In some examples of this disclosure, the RFID tag 208 and antennas 210, 212 may be overmolded or bonded to the tampering ring 206 during its manufacture. In some examples of this disclosure, to avoid damage to the RFID tag 208, the RFID tag 208 may be maintained by a vacuum within the tampering ring 206 instead of an electrostatic mechanism. To improve the readability of the RFID tag 208 from multiple angles, the RFID tag 208 may extend around the tampering ring 206, along at least half of the surface of the tampering ring 206, for example, 180 degrees.

[0044] In one example of this disclosure, the tamper-evident ring 206 may include a storage space for writing a unique device identification (UDI) tag for the needle cover 200. The storage space is password-protected so that only authorized persons can set the UDI tag. In one example of this disclosure, the upper part of the tamper-evident ring 206 may be connected to the lower part of the tamper-evident ring 206 via a bridge 216 extending around the tamper-evident ring 206. The tamper-evident ring 206 is configured such that, when sufficient force is applied, the bridge 216 breaks, separating the upper and lower parts of the tamper-evident ring 206. In one example of this disclosure, the lower part of the tamper-evident ring 206 may be operably coupled to a medical injection device 10, while the upper part of the tamper-evident ring 206 may be operably coupled to the needle cover 200. Each portion of the tampering ring 206 can be operably attached to the medical injection device 10 and the needle cover 200 via welding, adhesive, clips, or any other bonding method that secures the tampering ring 206 to these devices. The tampering ring 206 is configured to indicate that the needle cover 200 has been removed from the medical injection device 10 by the rupture of the bridge 216 under pressure. When the needle cover 200 is pulled out of the medical injection device 10, the bridge 216 is configured to rupture, thereby severing the antennas 210, 212 and deactivating the RFID tag 208. Thus, an indication that the needle cover 200 has been removed from the medical injection device 10 is communicated to a person, and a user who wishes to detect the medical injection device 10 may be unable to detect it. Then, the proximal end 218 of the outer shield 202 comes into contact with the shoulder 220 extending inward from the distal end 222 of the tampering ring 206, and the upper part 210 of the tampering ring 206 is pulled away from the tip 20 of the medical injection device 10 together with the needle cover 200. A tensile force is generated between the proximal end 218 of the outer shield 202 and the shoulder 220 of the tampering ring 206, and the tampering ring 206 is removed together with the needle cover 200.

[0045] In one example of this disclosure, the RFID tag 208 remains intact before the needle cover 200 is first removed from the medical injection device 10, and can be read by an RFID reader to identify unique device identification information from the time of manufacture of the needle cover 200 until it is removed from the medical injection device 10. After the needle cover 200 is removed from the medical injection device 10, the RFID tag 208 stops transmitting signals. Therefore, if a person uses an RFID reader and picks up a signal from the RFID tag 208, this indicates to the person that the needle cover 200 has not yet been removed from the medical injection device 10. If a person uses an RFID reader and does not pick up a signal from the RFID tag 208, this indicates to the person that the needle cover 200 has been removed from the medical injection device 10. By using an RFID reader, a person can quickly determine whether the needle cover 200 has been removed from multiple medical injection devices 10. Furthermore, this configuration allows a person to verify that the needle cover 200 is intact on the medical injection device 10 without opening the product packaging. Visual inspection is not required to determine the connection between the needle cover 200 and the medical injection device 10.

[0046] All components of the medical injection device 10 can be made of any known material, but it is preferable that they be made of medical-grade polymers.

[0047] While this disclosure has been described as having exemplary designs, it can be further modified within the technical idea and scope of the disclosure. Accordingly, this application is intended to encompass any variation, use, or adaptation of the disclosure using its general principles. Furthermore, this application is intended to encompass deviations from the disclosure such that the disclosure falls within the scope of known or customary practices in the relevant art and within the limitations of the appended claims.

Claims

1. A needle cover for protecting a needle attached to the tip of a medical injection device, wherein the tip extends from the distal end of the medical injection device, and the needle cover is An inner shield extending along the longitudinal axis, An outer shield that at least partially surrounds the inner shield and is operably coupled to the inner shield. Equipped with, The needle cover further comprises a tampering ring for identifying whether the needle cover has been removed from the tip of the medical injection device. The needle cover is characterized in that the tampering trace ring includes a lower and an upper part, each of which includes an antenna portion, the antenna portions of the lower and upper parts are connected in the circumferential direction, and a breakable conductive bridge is installed between the antenna portions of the lower and upper parts.

2. The tamper-evident ring includes at least one of a wireless communication tag, a radio frequency identification (RFID) tag, an ultra-wideband real-time location system (RTLS), a wireless RTLS, and an infrared RTLS, according to claim 1.

3. The needle cover according to claim 2, wherein the RFID tag is overmolded onto the tamper-evident ring.

4. The needle cover according to claim 1, wherein the tampering ring includes the bridge that establishes a breakable bond between the tampering ring and the medical injection device.

5. A medical injection device having a barrel extending from the proximal surface to the distal surface, wherein the tip is provided on the distal surface of the barrel, The medical injection device is equipped with a needle cover for protecting the needle attached to the tip of the medical injection device, and the needle cover is An inner shield extending along the longitudinal axis, An outer shield that at least partially surrounds the inner shield and is operably coupled to the inner shield. Equipped with, The needle cover further comprises a tampering ring for identifying whether the needle cover has been removed from the tip of the medical injection device. A medical injection device characterized in that the tampering ring includes a lower and an upper part, each of the lower and upper parts including an antenna portion, the antenna portions of the lower and upper parts being connected in the circumferential direction, and a breakable conductive bridge being installed between the antenna portions of the lower and upper parts.

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