Needle shield assembly for a syringe

Abstract

This invention relates to a needle shielding assembly (10) for a medical injection device (1) such as a syringe, the distal end of which includes a longitudinal hub portion (3) fitted with a needle (5), the needle shielding assembly (10) being removably engaged with the needle, the needle shielding assembly (10) comprising: a rigid shielding member (20) formed of a first material and elongated in the longitudinal direction, the rigid shielding member (20) having a wall (21) including an inner surface (22) and an outer surface (23); and a flexible shielding member (30) formed of a second material different from the first material. The shield (30) includes an outer layer (31) and an inner layer (32), the inner surface (31') of the outer layer covering at least a portion of the outer surface (23) of the rigid shield, and the inner layer sealing at least a portion of the hub portion (3) of the medical injection device (1) and at least partially covering the inner surface (22) of the rigid shield (20); a diaphragm (40) formed of a third material different from the first and second materials, the diaphragm (40) contacting at least partially the inner surface (22) of the rigid shield (20) and ensuring a tight seal of fluid at the distal end of the medical injection device (1).

Description

Technical Field

[0001] This invention relates to a needle shielding assembly for use in a medical injection device to cover a needle attached to the medical injection device; a medical injection device including said needle shielding assembly; and a method for manufacturing said needle shielding assembly. This invention is particularly applicable to the healthcare industry. Background Technology

[0002] In this application, the distal end of a component or device should be understood as the end furthest from the user's hand, and the proximal end should be understood as the end closest to the user's hand. Similarly, in this application, regarding the medical container of the present invention, "distal direction" should be understood as the injection direction, and "proximal direction" should be understood as the direction opposite to the injection direction, that is, the direction toward the hand of the user holding the container to perform the injection operation.

[0003] Medical injection devices, such as pre-fillable or pre-filled syringes, typically include a hollow body or barrel that forms a container for a medical product or composition. The body includes a distal end optionally provided with a needle and a proximal end typically provided with a flange. The distal end of the body is typically in the form of a longitudinal end defining a fluid path through which a medical solution is expelled from the hollow body.

[0004] When a medical injection device contains a needle, and to prevent any injury before final use, a needle shielding assembly is attached to the end to enclose the needle. This prevents people around the device from physically accessing the needle. A needle shielding assembly typically includes an inner needle shield made of an elastomeric material, and may also include an outer needle shield made of rigid plastic that surrounds the inner needle shield.

[0005] The internal needle shield ensures a tight seal for the medical injection device. To this end, the internal needle shield includes a sealing portion that seals against the outer surface of the syringe tip to provide a tight seal. The internal needle shield prevents any contamination of the medical composition by the external environment, thereby ensuring the integrity of the container closure. The internal needle shield further prevents any leakage of the composition from the needle outlet to the external environment. For this purpose, the needle is preferably punctured within the internal needle shield.

[0006] The outer needle shield typically surrounds the inner needle shield and provides rigid protection for the needle, helping to maintain its integrity during transport and / or storage.

[0007] One known drawback of needle shielding assemblies is that removing them from the end can be difficult. To do this, the user must grasp both the injection device and the needle shielding assembly and pull the shielding assembly by applying what may be considerable force.

[0008] The force required to remove a needle shield assembly is measured by a physical parameter known as "pull force". The pull force required to remove a known needle cover from an injection device such as a syringe can be quite high.

[0009] Therefore, users with diminished physical strength, such as those weakened by illness, may be unable to remove the needle shield and use the injection device on them. According to the medical composition stored in the medical injection device, it is known to adapt the composition of the inner needle shield to a material with elastomeric properties. In fact, depending on the composition of the inner needle shield, the medical composition can react differently. Therefore, the aim is to select an inner needle shield composition that does not react with the medical composition. Additionally, it is also necessary to adapt the material of the outer needle shield to the composition of the inner needle shield. In fact, all materials are incompatible, leading to the production of large quantities of needle shield assemblies, each range including a specific inner needle shield composition and a specific outer needle shield composition, both of which are compatible. Furthermore, different inner needle shield compositions, and therefore ranges of needle shield assemblies, do not have the same pull-out force. Therefore, the pull-out force is not repeatable, and this is unsettling for the user.

[0010] Therefore, there is a need for a needle shielding assembly that exhibits a constant pull-out force regardless of the formulation of the medical product contained within the tube, thereby reducing the need to produce a wide range of needle shielding assemblies and ensuring constant needle shielding properties, such as shielding properties regarding leakage. Summary of the Invention

[0011] A first aspect of the invention is a needle shielding assembly for a medical injection device, such as a syringe, the medical injection device including a longitudinal hub portion at its distal end, the longitudinal hub portion being equipped with a needle, the needle shielding assembly being designed to be removably engaged with the needle, the needle shielding assembly comprising:

[0012] - A rigid shielding element, formed of a first material, elongated in the longitudinal direction, the rigid shielding element having a wall comprising an inner surface and an outer surface.

[0013] - A flexible shielding element, formed of a second material different from the first material, comprising an outer layer and an inner layer, the inner surface of the outer layer covering at least a portion of the outer surface of the rigid shielding element, the inner layer capable of sealingly receiving at least a portion of the hub portion of a medical injection device, and at least partially covering the inner surface of the rigid shielding element.

[0014] A diaphragm, formed of a third material different from the first and second materials, is at least partially in contact with the inner surface of a rigid shield and is capable of ensuring a fluid-impermeable seal at the distal end of the medical injection device.

[0015] Unwilling to be bound by theory, the needle shield according to the invention is believed to allow a constant pull-out force without requiring adjustment of the flexible shield according to the medical composition stored in the medical injection device. In fact, in the needle shield assembly according to the invention, only the diaphragm composition is adjusted according to the medical composition. Therefore, the pull-out force is repeatable. Furthermore, the needle shield assembly is sealed, preventing the risk of leakage. There is no risk of the medical composition escaping from the needle. Additionally, the integrity of the medical injection device's barrel is maintained. There is no risk of impurities contaminating the medical composition present within the barrel of the medical injection device. Moreover, in the prior art, it is known that the outer portion of the needle shield assembly is made of a rigid material and optionally has a gripping portion, which may irritate the user's fingers after repeated injections, i.e., repeated removal of the needle shield assembly. In contrast, in the present invention, the outer portion of the needle shield assembly is made of a flexible material, providing a soft tactile experience for the user. The rigidity of the needle shield assembly of the present invention facilitates its grip. The needle shield assembly can be easily removed without any risk of bending the needle.

[0016] In one embodiment, the needle shielding assembly further includes an annular bridge that links the inner and outer layers of the flexible shield at the proximal open end. In this embodiment, the seal between the flexible and rigid shields is optimized.

[0017] In another embodiment, the inner and outer layers of the flexible shield are separated by the wall of the rigid shield. In one embodiment, the wall of the rigid shield includes a first portion at the distal end of the needle shield assembly and a second portion at the proximal end of the needle shield assembly, the first portion including a first cavity capable of receiving a diaphragm, and the second portion including a second cavity capable of receiving the inner layer of the flexible shield.

[0018] In one embodiment, the inner surface of the outer layer of the flexible shield surrounds a first portion of the wall of the rigid shield, and optionally surrounds a second portion of the wall of the rigid shield.

[0019] In one embodiment, the rigid shielding member includes a circular groove at the proximal end of the needle shielding assembly.

[0020] Additionally, the annular seal may be located on the flexible shield and configured to fit within a circular groove in the rigid shield. Preferably, the annular seal is made of rubber or thermoplastic elastomer (TPE). In this embodiment, there is no risk of the syringe being accidentally removed from the needle shield assembly.

[0021] In one embodiment, the flexible shield includes a rib at the proximal end of the needle shield, the rib being configured to receive a recess on the outer surface of the hub portion of the medical injection device. In this embodiment, the syringe is well engaged in the needle shield assembly.

[0022] Preferably, the first material is a thermoplastic. The first material can be polypropylene (PP), polyethylene (PE), polyethylene terephthalate (PET), polystyrene (PS), or polycarbonate (PC). Preferably, the second material is a deformable material made of a material with elastomeric properties, such as thermoplastic elastomer (TPE).

[0023] Advantageously, the first material is PP and the second material is TPE. In this embodiment, a specific chemical bond is believed to be achieved between the two materials. Therefore, the flexible shielding is firmly attached to the rigid shielding.

[0024] Preferably, the third material is rubber, such as butyl rubber.

[0025] In one embodiment, the wireless transmitter is located between a rigid shield and a flexible shield. The wireless transmitter can be a radio frequency identification tag, an ultra-wideband real-time location system (RTLS), a Wi-Fi real-time load prediction system (RTLF), or an infrared RTLS.

[0026] Preferably, the wireless transmitter is a radio frequency identification (RFID) tag located between the rigid and flexible shielding components, the RFID tag including at least one RFID antenna. In this embodiment, the needle shielding assembly of the present invention is believed to allow individual tracking of each medical injection device from the manufacturing process to its final use. Furthermore, the RFID tag is well protected against removal or external damage that may occur during the packaging, storage, and distribution of the medical injection device. Moreover, the RFID tag is concealed between the rigid and flexible shielding components of the needle shielding assembly, with no visual impact. Additionally, the insertion of the RFID tag has only a limited impact on the manufacturing process.

[0027] In one embodiment, the RFID tag does not include a chip. This chipless RFID tag does not require a chip to be read by a reader.

[0028] In one embodiment, the chip is connected to at least one RFID antenna.

[0029] In one embodiment, the RFID tag is a low-frequency radio frequency identification (LF-RFID) tag. Low frequency is typically from about 30 kHz to 300 kHz. In this embodiment, the RFID reader can read the LF-RFID tag, for example, at a distance of at most about ten centimeters.

[0030] In one embodiment, the RFID tag is a high-frequency radio frequency identification (HF-RFID) tag. The high frequency is typically around 1-15 MHz. In this embodiment, an RFID reader can read the HF-RFID tag, for example, at a distance of approximately one meter.

[0031] In one embodiment, the RFID tag is a high-frequency near-field communication (HF-NFC) tag. The frequency is typically around 13.56 MHz. In this embodiment, an NFC reader can read the HF-NFC tag, for example, at a distance of at most a few centimeters. The difference between HF-NFC and HF-RFID is that HF-NFC can be read by an NFC-enabled smartphone. In one embodiment, the RFID tag is a dual-frequency tag that incorporates both HF-NFC and UHF RFID. For example, it can be read by either an NFC-enabled smartphone or a UHF reader.

[0032] Preferably, the RFID tag is an ultra-high frequency radio frequency identification (UHF-RFID) tag. Ultra-high frequency is typically around 400-1000 MHz. In this embodiment, the RFID reader can read the UHF-RFID tag, for example, at a distance of approximately 15 meters.

[0033] In one embodiment, the wireless transmitter contacts the outer surface of the wall of the rigid shield and is surrounded by the inner surface of the outer layer of the flexible shield.

[0034] Preferably, the wireless transmitter contacts the outer surface of the wall of the rigid shield and is surrounded by the inner surface of the outer layer of the flexible shield.

[0035] Preferably, the width of the RFID tag extends between 10% and 100% of the circumference of the outer surface of the rigid shield, excluding 100%, and advantageously between 40% and 100%, more preferably between 50% and 100%, or between 50% and 100%, and advantageously between 50% and 90%. In this embodiment, the data transmission level to the RFID reader is believed to be improved.

[0036] Advantageously, the extended length of the RFID tag is strictly less than 100% of the length of the pin shielding assembly. Preferably, the length of the RFID tag extends at least 15%, more preferably 25%, of the length of the pin shielding assembly. It is believed that the length of the tag will affect the data transmission level from the RFID tag to the RFID reader.

[0037] In one embodiment, the rigid shield includes a recess configured to receive a portion of the wireless transmitter, particularly a portion of an RFID tag. In this embodiment, the recess is believed to increase the seal on the wireless transmitter (particularly a portion of the RFID tag), thereby eliminating the risk of the wireless transmitter (particularly a portion of the RFID tag) falling out during the manufacturing process.

[0038] A second aspect of the invention is a medical device comprising: a longitudinal hub portion at its distal end, the longitudinal hub portion being equipped with a needle; and a needle shielding assembly according to the invention sealingly engaging the needle. Preferably, the medical injection device is a syringe.

[0039] A third aspect of the present invention is a method for manufacturing a needle shielding assembly according to any one of the preceding claims, comprising:

[0040] A. A rigid shielding element is provided, the rigid shielding element being formed of a first material and being elongated in the longitudinal direction, the rigid shielding element having a wall including an inner surface and an outer surface.

[0041] B. Applying a flexible shielding member formed of a second material different from the first material to a rigid shielding member, the flexible shielding member comprising an outer layer and an inner layer, the outer layer being configured to cover at least a portion of the outer surface of the rigid shielding member, and the inner layer being configured to at least partially cover the inner surface of the rigid shielding member.

[0042] C. Inserting a diaphragm into a rigid shield, the diaphragm being formed of a third material different from the first and second materials, the diaphragm being configured to at least partially contact the inner surface of the rigid shield.

[0043] In one embodiment, in step A), the rigid shield is injection molded, and the method includes step D), performed prior to step A), wherein the wireless transmitter is placed in the mold before the rigid shield is injection molded. In another embodiment, in step A), the rigid shield is injection molded, and the method includes step D), performed after step A), wherein the wireless transmitter is overmolded onto the outer surface of the wall of the rigid shield before being surrounded by the outer layer of the flexible shield.

[0044] In one embodiment, in step B), the flexible shield is applied to the rigid shield by overmolding. In another embodiment, steps A) and B) are performed simultaneously, for example by injection molding, particularly by a dual injection molding process.

[0045] In step C), the diaphragm is snapped into place within the rigid shield.

[0046] In one embodiment, the method further includes step E), performed after step A), wherein the annular seal is overmolded or clamped onto the rigid shield. Attached Figure Description

[0047] The invention and the advantages therefrom will become apparent from the following detailed description given with reference to the accompanying drawings:

[0048] Figure 1 This is a side view of a needle shielding assembly according to an embodiment of the present invention;

[0049] Figure 2 It is assembled with a basis Figure 1 The illustrated embodiment is a longitudinal sectional view of a portion of a medical injection device containing a needle shielding assembly.

[0050] Figure 3 It is based on Figure 1 and 2 A cross-sectional view of the needle shielding assembly of the embodiment illustrated herein;

[0051] Figure 4 It is based on Figure 1 and Figure 2 A cross-sectional view of the needle shielding assembly of the embodiment illustrated herein;

[0052] Figure 5 This is a horizontal view of a needle shielding assembly according to an embodiment of the present invention. Detailed Implementation

[0053] Figure 1 The needle shielding assembly 10 is shown, which has a longitudinal axis A. L and transverse axis A T Designed for use in covering medical injection devices 1 ( Figure 2 ).

[0054] Figure 2 A medical injection device 1, such as a syringe, is shown. The medical injection device 1 includes a barrel 2 having a longitudinal axis A. L and transverse axis A T The cylinder 2 includes sidewalls 8, thus forming a reservoir suitable for containing a medical composition to be injected.

[0055] The medical injection device or syringe 1 also includes a longitudinal hub portion 3, which is disposed at its distal end 4 and extends from the distal end of the barrel 2 along axis A. L Extension. Hub portion 3 is partially hollow to form a channel for fluid communication with cylinder 2.

[0056] The needle 5 can be attached to the hub portion 3 of the medical injection device. For example, the needle can be glued to the hub portion 3. In particular, the needle shielding assembly 10 is designed to cover the hub portion 3 of the medical injection device 1 in order to protect the needle. The medical injection device 1 may also include a distal shoulder 6 at its distal end, which narrows relative to the barrel 2.

[0057] The medical injection device or syringe 1 also includes a plunger rod (not shown) having a plunger (not shown) and a cartridge stopper (not shown) disposed at its end. The plunger is slidably moved within the cartridge 2 along the inner surface of the sidewall 8, thereby discharging the medical composition from the cartridge 2 through the needle 5. The medical composition contained in the medical injection device 1 can be, for example, a liquid agent, a drug, or a pharmaceutical composition (such as a vaccine).

[0058] like Figures 1 to 2 As shown in the figure, the needle shielding assembly 10 includes components along the longitudinal axis A. L A rigid shield 20, elongated in the longitudinal direction, has a wall 21 comprising an inner surface 22 and an outer surface 23. The rigid shield is typically made of a rigid material. Preferably, the rigid shield 20 is made of polypropylene (PP), polyethylene (PE), polyethylene terephthalate (PET), polystyrene (PS), or polycarbonate (PC), more preferably of polypropylene. The rigid shield 20 can be manufactured by injection molding.

[0059] The needle shielding assembly 10 also includes a flexible shielding element 30, which comprises an outer layer 31 and an inner layer 32. The outer layer 31 covers at least a portion of the outer surface 23 of the rigid shielding element, and the inner layer 32 is capable of sealingly receiving at least a portion of the hub portion 3 of the medical injection device 1 and at least partially covers the inner surface 22 of the rigid shielding element 20. Preferably, the flexible shielding element 30 is made of a deformable material such as TPE (thermoplastic elastomer). The flexible shielding element 30 can be disposed on the rigid shielding element 20 by overmolding.

[0060] The needle shielding assembly 10 also includes a diaphragm 40 that at least partially contacts the inner surface 22 of the rigid shield 20 and ensures a fluid-impermeable seal at the distal end of the medical injection device 1. Preferably, the diaphragm 40 is made of rubber (such as butyl rubber). The diaphragm 40 can be inserted into the rigid shield 20.

[0061] According to one embodiment, the rigid shield 20 includes an open distal end and an open proximal end. The flexible shield 30 may also include an open distal end and an open proximal end. Typically, the diaphragm 50 includes a closed distal end and an open proximal end.

[0062] like Figures 1 to 2As illustrated, the needle shielding assembly 1 also includes an annular bridge 33, which links the inner layer 32 and the outer layer 31 of the flexible shielding member 30 at the proximal open end.

[0063] The wall 21 of the rigid shield 20 may include a first portion P1 located at the distal end of the needle shield assembly 10 and a second portion P2 located at the proximal end of the needle shield assembly 10. The first portion P1 may include a first cavity C1 capable of receiving the diaphragm 40, and the second portion P2 includes a second cavity C2 capable of receiving the inner layer 32 of the flexible shield 30.

[0064] For example, the outer layer 31 of the flexible shield 30 has an inner surface 31' that surrounds the first part P1 and the second part P2 of the wall 21 of the rigid shield 20.

[0065] The flexible shield 30 may include a rib 34 at the proximal end of the needle shield assembly 10, the rib 34 being configured to abut against a recess (not shown) located on the outer surface of the hub portion 3 of the syringe 1.

[0066] The pin shielding assembly may include a wireless transmitter, preferably an RFID tag 50, located between a rigid shield 20 and a flexible shield 30, the RFID tag 50 including at least one RFID antenna (not shown). The RFID tag 50 may also include a chip connected to the antenna. The RFID tag 50 may be a chipless RFID tag, an LF-RFID tag, an HF-RFID tag, a UHF-RFIF tag, or an HF-NFC RFID tag.

[0067] Preferably, the RFID tag 50 contacts the outer surface 23 of the wall 21 of the rigid shield 20 and is surrounded by the inner surface 31' of the outer layer 31. Advantageously, the rigid shield 20 includes a groove 35 configured to receive part of the RFID tag 50.

[0068] Preferably, the width (not shown) of the RFID tag 50 extends between 10% and 100% of the circumference of the outer surface of the rigid shield 20, excluding 100%, and advantageously between 40% and 100%, more preferably between 50% and 100%, or between 50% and 100%, and advantageously between 50% and 90% of the circumference of the outer surface of the rigid shield 20. Advantageously, the length L of the RFID tag 50... T Strictly less than 100% of the length L of the needle shielding assembly 10. Preferably, the length L of the RFID tag 50 is... T The antenna extends over at least 15%, more preferably 25%, of the length L of the pin shielding assembly 10. This maximizes the antenna's exposure to the reader's electromagnetic waves.

[0069] For example, the RFID tag 50 can be placed in the mold before the rigid shield 20 is injection molded. Alternatively, the RFID tag 50 can be overmolded onto the outer surface 23 of the wall 21 of the rigid shield 20 before being surrounded by the outer layer 31 of the flexible shield 30.

[0070] Figure 3 The diagram shows the cross-section AA of the needle shielding assembly 1. Figure 2 ) sectional view, and Figure 4 The cross-section BB of the needle shielding assembly 1 is shown. Figure 4 ) sectional view.

[0071] Figure 5 A needle shielding assembly 10 according to another embodiment is shown, which includes a needle shielding assembly along a longitudinal axis A. L A rigid shield 20, elongated in the longitudinal direction, has a wall 21 including an inner surface 22 and an outer surface 23. The rigid shield is typically made of a rigid material. Preferably, the rigid shield 20 is made of polypropylene (PP), polyethylene (PE), polyethylene terephthalate (PET), polystyrene (PS), or polycarbonate (PC), more preferably of polypropylene. The rigid shield 20 can be manufactured by injection molding.

[0072] The needle shielding assembly 10 also includes a flexible shielding element 30, which comprises an outer layer 31 and an inner layer 32. The outer layer 31 covers at least a portion of the outer surface 23 of the rigid shielding element, and the inner layer 32 is capable of sealingly receiving at least a portion of the hub portion 3 of the medical injection device 1 and at least partially covering the inner surface 22 of the rigid shielding element 20. Preferably, the flexible shielding element 30 is made of a deformable material such as TPE (thermoplastic elastomer). The flexible shielding element 30 can be disposed on the rigid shielding element 20 by overmolding.

[0073] The needle shielding assembly 10 also includes a diaphragm 40 that at least partially contacts the inner surface 22 of the rigid shield 20 and ensures a fluid-impermeable seal at the distal end of the medical injection device 1. Preferably, the diaphragm 40 is made of rubber (such as butyl rubber). The diaphragm 40 can be inserted into the rigid shield 20.

[0074] In this embodiment, the rigid shield 20 includes an open distal end and an open proximal end, the flexible shield 30 includes an open distal end and an open proximal end, and the diaphragm 50 includes a closed distal end and an open proximal end.

[0075] In this example, the inner layer 32 and the outer layer 31 are separated by the wall 21 of the rigid shield.

[0076] The wall 21 of the rigid shield 20 may include a first portion P1 located at the distal end of the needle shield assembly 10 and a second portion P2 located at the proximal end of the needle shield assembly 10. The first portion P1 may include a first cavity C1 capable of receiving the diaphragm 40, and the second portion P2 includes a second cavity C2 capable of receiving the inner layer 32 of the flexible shield 30.

[0077] For example, the outer layer 31 of the flexible shield 30 has an inner surface 31' that surrounds the first portion P1.

[0078] The flexible shield 30 may include a rib (not shown) at the proximal end of the needle shield assembly 10, the rib being configured to abut against a recess (not shown) located on the outer surface of the hub portion 3 of the syringe 1.

[0079] Preferably, the rigid shield 20 includes a circular groove 24 at the proximal end of the needle shield assembly 10, the circular groove 24 being configured to receive an annular seal 60 surrounding a rib of the flexible shield 30. The annular seal 60 may be overmolded onto the rigid shield. For example, the annular seal is made of rubber or TPE.

[0080] The pin shielding assembly may include an RFID tag 50 located between a rigid shield 20 and a flexible shield 30, the RFID tag 50 including at least one RFID antenna (not shown). The RFID tag 50 may also include a chip connected to the antenna. The RFID tag 50 may be a chipless RFID tag, an LF-RFID tag, an HF-RFID tag, a UHF-RFIF tag, or an HF-NFC RFID tag.

[0081] Preferably, the RFID tag 50 that contacts the outer surface 23 of the wall 21 of the rigid shield 20 is surrounded by the inner surface 31' of the outer layer 31. Advantageously, the rigid shield 20 includes a groove 35 configured to receive part of the RFID tag 50.

[0082] Preferably, the width (not shown) of the RFID tag 50 extends between 10% and 100% of the circumference of the outer surface of the rigid shield, excluding 100%, and advantageously between 40% and 100%, more preferably between 50% and 100%, or between 50% and 100%, and advantageously between 50% and 90% of the circumference of the outer surface of the rigid shield 20. Advantageously, the length L of the RFID tag 50... T Strictly less than 100% of the length L of the needle shielding assembly 10. Preferably, the length L of the RFID tag 50 is... T The antenna extends over at least 15%, more preferably 25%, of the length L of the pin shielding assembly 10. This maximizes the antenna's exposure to the reader's electromagnetic waves.

[0083] For example, the RFID tag 50 can be placed in the mold before the rigid shield 20 is injection molded. Alternatively, the RFID tag 50 can be overmolded onto the outer surface 23 of the wall 21 of the rigid shield 20 before being surrounded by the outer layer 31 of the flexible shield 30.

[0084] The needle shielding according to the invention provides the user with a soft touch and a constant pull force.

Claims

1. A needle shielding assembly (10) for a medical injection device (1), the medical injection device including a longitudinal hub portion (3) at its distal end, the longitudinal hub portion being equipped with a needle (5), the needle shielding assembly (10) being intended to be removably engaged with the needle, the needle shielding assembly (10) comprising: - A rigid shield (20), the rigid shield (20) being formed of a first material and being elongated in the longitudinal direction, the rigid shield (20) having a wall (21) including an inner surface (22) and an outer surface (23), - A flexible shield (30) formed of a second material different from the first material, the flexible shield (30) comprising an outer layer (31) and an inner layer (32), the inner surface (31') of the outer layer (31) covering at least a portion of the outer surface (23) of the rigid shield, the inner layer (32) capable of receiving at least a portion of the hub portion (3) of the medical injection device (1) in a sealing manner, and at least partially covering the inner surface (22) of the rigid shield (20); and a diaphragm (40) formed of a third material different from the first and second materials, the diaphragm (40) at least partially contacting the inner surface (22) of the rigid shield (20), and capable of ensuring a fluid-impermeable seal at the distal end of the medical injection device (1).

2. The needle shielding assembly (10) according to claim 1, wherein, The needle shielding assembly (10) further includes an annular bridge (33) that links the inner layer (32) and outer layer (31) of the flexible shield (30) at the proximal open end of the needle shielding assembly (10).

3. The needle shielding assembly (10) according to claim 1, wherein the inner layer (32) and the outer layer (31) are separated by the wall (21) of the rigid shield.

4. The needle shielding assembly (10) according to any one of the preceding claims, wherein, The wall (21) of the rigid shield (20) includes a first portion (P1) at the distal end of the needle shield assembly (10) and a second portion (P2) at the proximal end of the needle shield assembly (10). The first portion (P1) includes a first cavity (C1) capable of receiving the diaphragm (40), and the second portion (P2) includes a second cavity (C2) capable of receiving the inner layer (32) of the flexible shield (30).

5. The needle shielding assembly (10) according to claim 4, wherein, The inner surface (31') of the outer layer (31) of the flexible shield (30) surrounds a first portion (P1) of the wall (21) of the rigid shield (20) and optionally surrounds a second portion (P2) of the wall (21) of the rigid shield (20).

6. The needle shielding assembly (10) according to any one of the preceding claims, wherein, The rigid shield (20) includes a circular groove (24) at the proximal end of the needle shield assembly (10).

7. The pin shielding assembly (10) according to claim 6, wherein, The annular seal (60) can be placed on the flexible shield (30) and can be configured to fit into the circular groove (24) of the rigid shield (20).

8. The needle shielding assembly (10) according to any one of the preceding claims, wherein, A wireless transmitter is provided between the rigid shield (20) and the flexible shield (30).

9. The pin shielding assembly (10) according to claim 8, wherein, The wireless transmitter is in contact with the outer surface (23) of the wall (21) of the rigid shield (20) and is surrounded by the inner surface (31') of the outer layer (31) of the flexible shield (30).

10. The pin shielding assembly (10) according to claim 9, wherein, The rigid shield (20) includes a groove (35) configured to receive part of the wireless transmitter.

11. The needle shielding assembly (10) according to claim 1, wherein, The medical injection device (1) includes a syringe.

12. A medical injection device (1), the medical injection device comprising: The longitudinal hub portion (3) at its distal end is equipped with a needle (5) and a needle shielding assembly (10) according to any one of the preceding claims, the needle shielding assembly (10) sealingly engaging the needle (5).

13. A method for manufacturing a needle shielding assembly (10) according to any one of claims 1 to 11, comprising: A. A rigid shield (20) is provided, the rigid shield being formed of a first material and being elongated in the longitudinal direction, the rigid shield having a wall (21) including an inner surface (22) and an outer surface (23). B. A flexible shield (30) formed of a second material different from the first material is applied to the rigid shield (20), the flexible shield (30) comprising an outer layer (31) and an inner layer (32), the outer layer being configured to cover at least a portion of the outer surface (23) of the rigid shield, and the inner layer being configured to at least partially cover the inner surface (22) of the rigid shield (20), and C. Insert a diaphragm (40) into the rigid shield, the diaphragm (40) being formed of a third material different from the first and second materials, the diaphragm (40) being configured to at least partially contact the inner surface (22) of the rigid shield (20).

14. The method according to claim 13, wherein, In step A), the rigid shield (20) is injection molded, and the method includes step D) performed prior to step A), wherein the wireless transmitter is placed in the mold prior to the injection molding of the rigid shield (20).

15. The method of claim 13, wherein in step A), the rigid shield (20) is injection molded, and wherein the method includes step D) performed after step A), wherein the wireless transmitter is overmolded on the outer surface (23) of the wall (21) of the rigid shield (20) before being surrounded by the outer layer (31) of the flexible shield (30).

16. The method according to any one of claims 13 to 15, wherein, In step B), the flexible shield (30) is applied to the rigid shield (20) by overmolding.

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