Needle Shield Assembly for a Syringe

Abstract

The present invention relates to a needle shield assembly for a medical injection device such as a syringe including at its distal end a longitudinal hub portion equipped with a needle on which said needle shield assembly is intended to be removably engaged, the said needle shield assembly including a rigid shield elongated in an longitudinal direction formed of a first material, said rigid shield having a wall including an inner surface and an outer surface, a flexible shield formed of a second material different from the first material, said flexible shield including an outer layer having an inner surface covering at least part of the rigid shield outer surface and an inner layer, being capable of receiving in a sealing way at least part of the hub portion of the medical injection device, and covering at least partly the inner surface of the rigid shield and a septum formed of a third material different from the said first and second materials, said septum being at least partly in contact with the inner surface of the rigid shield and being capable of ensuring a fluid and tight seal of the distal end of the medical injection device.

Claims

1. A needle is shield assembly for a medical injection device, such as a syringe, comprising at its distal end a longitudinal hub portion equipped with a needle on which said needle shield assembly is intended to be removably engaged, the said needle shield assembly comprising: a rigid shield elongated in a longitudinal direction formed of a first material, said rigid shield having a wall including an inner surface and an outer surface, a flexible shield formed of a second material different from the first material, said flexible shield comprising an outer layer having an inner surface covering at least part of the rigid shield outer surface and an inner layer, being capable of receiving in a sealing way at least part of the hub portion of the medical injection device, and covering at least partly the inner surface of the rigid shield and a septum formed of a third material different from the said first and second materials, said septum being at least partly in contact with the inner surface of the rigid shield and being capable of ensuring a fluid and tight seal of the distal end of the medical injection device.

2. The needle shield assembly according to claim 1, wherein the needle shield assembly further comprises an annular bridge linking the inner layer and the outer layer of the flexible shield at a proximal open end of the needle shield assembly.

3. The needle shield assembly according to claim 1, wherein the inner and the outer layers are separated by the rigid shield wall.

4. The needle shield assembly according to claim 1, wherein the wall of the rigid shield comprises a first portion located at a distal end of the needle shield assembly and a second portion being located at a proximal end of the needle shield assembly, said first portion comprising a first cavity capable of receiving the septum and said second portion comprising a second cavity capable of receiving the inner layer of the flexible shield.

5. The needle shield assembly according to claim 4, wherein the inner surface of the outer layer of the flexible shield surrounds the first portion of the wall of the rigid shield and optionally the second portion of the wall of the rigid shield.

6. The needle shield assembly according to claim 1, wherein the rigid shield comprises at a proximal end of the needle shield assembly a circular groove.

7. The needle shield assembly according to claim 6, wherein a ring seal may be located on the flexible shield and may be configured to fit in the circular groove of the rigid shield.

8. The needle shield assembly according to claim 1, wherein a wireless transmitter is located between the rigid shield and the flexible shield.

9. The needle shield assembly according to claim 8, wherein the wireless transmitter is in contact with 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.

10. The needle shield assembly according to claim 9, wherein the rigid shield comprises grooves configured to receive a part of the wireless transmitter.

11. A medical injection device comprising at its distal end a longitudinal hub portion equipped with a needle and a needle shield assembly according to claim 1 sealingly engaging the needle.

12. A method for manufacturing a needle shield assembly, comprising: A. providing a rigid shield elongated in a longitudinal direction formed of a first material, said rigid shield having a wall including an inner surface and an outer surface, B. implementing a flexible shield formed of a second material different from the first material onto the rigid shield, said flexible shield comprising an outer layer configured to cover at least part of the rigid shield outer surface and an inner layer, and configured to cover at least partly the inner surface of the rigid shield, and C. inserting a septum within the rigid shield, said septum being formed of a third material different from the said first and second materials, said septum being configured to be at least partly in contact with the inner surface of the rigid shield.

13. The method according to claim 12, wherein in step A), the rigid shield is injection molded, and wherein the method comprises a step D) performed before step A) wherein a wireless transmitter is disposed in a mold before the injection molding of the rigid shield.

14. The method according to claim 12, wherein in step A), the rigid shield is injection molded, and wherein the method comprises a step D) performed after step A) wherein a wireless transmitter is overmolded on the outer surface of the wall of the rigid shield before being surrounded by the outer layer of the flexible shield.

15. The method according to claim 12, wherein in step B), the flexible shield is implemented on the rigid shield by overmolding.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0048] The terms Fig., Figs., Figure, and Figures are used interchangeably in the specification to refer to the corresponding figures in the drawings.

[0049] The invention and advantages arising therefrom will clearly emerge from the detailed description that is given below with reference to the appended drawings as follows:

[0050] FIG. 1 is a transversal view of a needle shield assembly according to one embodiment of the invention;

[0051] FIG. 2 is a longitudinal cross sectional view of a part of the medical injection device furnished with the needle shield assembly according to the embodiment illustrated in FIG. 1;

[0052] FIG. 3 is a transversal cross sectional view of the needle shield assembly according to the embodiment illustrated in FIGS. 1 and 2;

[0053] FIG. 4 is a transversal cross sectional view of the needle shield assembly according to the embodiment illustrated in FIGS. 1 and 2 and

[0054] FIG. 5 is a transversal view of a needle shield assembly according to one embodiment of the invention.

DESCRIPTION OF THE INVENTION

[0055] FIG. 1 shows a needle shield assembly 10 having a longitudinal axis A.sub.L and a transversal axis A.sub.T intended to cover a medical injection device 1 (FIG. 2).

[0056] FIG. 2 shows the medical injection device 1 such as a syringe comprising a barrel 2 having a longitudinal axis A.sub.L and a transversal axis A.sub.T. Said barrel 2 comprises a side wall 8 and thus forms a reservoir, adapted to contain a medical composition to be injected.

[0057] The medical injection device or syringe 1 further comprises a longitudinal hub portion 3 provided at its distal end 4 and extending along the axis A.sub.L from the distal end of the barrel 2. The hub portion 3 is partially hollow so as to form a channel in fluidic communication with the barrel 2.

[0058] A needle 5 may be attached to the hub portion 3 of the medical injection device. For example, the needle may be glued to the hub portion 3. In particular, the needle shield assembly 10 is intended to cover the hub portion 3 of the medical injection device 1, so as to protect the needle. The medical injection device 1 can also include, at its distal end, a distal shoulder 6 which narrows with respect to the barrel 2.

[0059] The medical injection device or syringe 1 also includes a plunger rod (not shown) having a plunger (not shown) and a barrel stopper (not shown) provided at an end thereof. The plunger is caused to slidably move in the barrel 2 along an inner surface of the side wall 8 to cause the medical composition to be expelled from the barrel 2 through the needle 5. The medical composition comprised in the medical injection device 1 may be for example, a liquid medicament, a drug or a pharmaceutical composition such as a vaccine.

[0060] As illustrated in FIGS. 1-2, the needle shield assembly 10 comprises a rigid shield 20 elongated in an longitudinal direction along longitudinal axis A.sub.L, said rigid shield 20 having a wall 21 including an inner surface 22 and an outer surface 23. The rigid shield is typically made of rigid material. Preferably, the rigid shield 20 is made of polypropylene (PP), polyethylene (PE), polyethylene terephthalate (PET), polystyrene (PS) or polycarbonate (PC), much preferably of polypropylene. The rigid shield 20 can be manufactured by injection molding.

[0061] The needle shield assembly 10 further comprises a flexible shield 30, said flexible shield 30 comprising an outer layer 31 covering at least part of the rigid shield outer surface 23 and an inner layer 32, being capable of receiving in a sealing way at least part of the hub portion 3 of the medical injection device 1, and covering at least partly the inner surface 22 of the rigid shield 20. Preferably, the flexible shield 30 is made of a deformable material such as TPE (Thermo Plastic Elastomer). The flexible shield 30 may be provided on the rigid shield 20 by overmolding.

[0062] The needle shield assembly 10 further comprises a septum 40 being at least partly in contact with the inner surface 22 of the rigid shield 20 and being capable of ensuring a fluid and tight seal of the distal end of the medical injection device 1. Preferably, the septum 40 is made of rubber, such as butyl rubber. The septum 40 may be inserted within the rigid shield 20.

[0063] According to an embodiment, the rigid shield 20 comprises an opened distal end and an opened proximal end. The flexible shield 30 may also comprise an opened distal end and an opened proximal end. Typically, the septum 50 comprises a closed distal end and an opened proximal end.

[0064] As illustrated in FIGS. 1-2, the needle shield assembly 1 further comprises an annular bridge 33 linking the inner layer 32 and the outer layer 31 of the flexible shield 30 at the proximal open end.

[0065] The wall 21 of the rigid shield 20 may comprise a first portion P1 located at the distal end of the needle shield assembly 10 and a second portion P2 being located at the proximal end of the needle shield assembly 10. The first portion P1 may comprise a first cavity C1 capable of receiving the septum 40 and said second portion P2 comprises a second cavity C2 capable of receiving the inner layer 32 of the flexible shield 30.

[0066] For example, the outer layer 31 of the flexible shield 30 has an inner surface 31 surrounding the first portion P1 and the second portion P2 of the wall 21 of the rigid shield 20.

[0067] The flexible shield 30 may comprise at the proximal end of the needle shield assembly 10 ribs 34 configured to receive recesses (not shown) located on an outer surface of the hub portion 3 of the syringe 1.

[0068] The needle shield assembly may comprise a wireless transmitter, preferably a RFID tag 50 located between the rigid shield 20 and the flexible shield 30, said RFID tag 50 comprising at least one RFID antenna (not shown). The RFID tag 50 may further comprise a chip connected to the antenna. The RFID tag 50 may be a chipless RFID tag, a LF-RFID tag, a HF-RFID tag or an UHF-RFIF tag, or a HF-NFC RFID tag.

[0069] Preferably, the RFID tag 50 is in contact with the outer surface 23 of the wall 21 of the rigid shield 20 and is surrounded by an inner surface 31 of the outer layer 31. Advantageously, the rigid shield 20 comprises grooves 35 configured to receive a part of the RFID tag 50.

[0070] Preferably, the RFID tag 50 has a width (not shown) extending between 10% and 100% of the circumference of the outer surface of the rigid shield, 100% being excluded, and advantageously between 40% and 100%, more preferably between 50 and 100%, or between 50 to 100% and advantageously between 50% and 90% of the circumference of the outer surface of the rigid shield 20. Advantageously, the RFID tag 50 has a length LT extending strictly less than 100% of a length L of the needle shield assembly 10. Preferably, the RFID tag 50 has a length Lr extending over at least 15%, more preferably 25% of a length L of the needle shield assembly 10. This enables maximizing the exposition of the antenna to electromagnetic waves of a reader.

[0071] For example, the RFID tag 50 may be disposed in a mold before the injection molding of the rigid shield 20. Alternatively, the RFID tag 50 may be 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.

[0072] FIG. 3 illustrated a cross view of the section A-A (FIG. 2) of the needle shield assembly 1 and FIG. 4 illustrated a cross view of the section B-B (FIG. 4) of the needle shield assembly 1.

[0073] FIG. 5 shows a needle shield assembly 10 according another embodiment comprising a rigid shield 20 elongated in an longitudinal direction along longitudinal axis A.sub.L, said rigid shield 20 having a wall 21 including an inner surface 22 and an outer surface 23. The rigid shield is typically made of rigid material. Preferably, the rigid shield 20 is made of polypropylene (PP), polyethylene (PE), polyethylene terephthalate (PET), polystyrene (PS) or polycarbonate (PC), much preferably of polypropylene. The rigid shield 20 can be manufactured by injection molding.

[0074] The needle shield assembly 10 further comprises a flexible shield 30, said flexible shield 30 comprising an outer layer 31 covering at least part of the rigid shield outer surface 23 and an inner layer 32, being capable of receiving in a sealing way at least part of the hub portion 3 of the medical injection device 1, and covering at least partly the inner surface 22 of the rigid shield 20. Preferably, the flexible shield 30 is made of a deformable material such as TPE (Thermo Plastic Elastomer). The flexible shield 30 may be provided on the rigid shield 20 by overmolding.

[0075] The needle shield assembly 10 further comprises a septum 40 being at least partly in contact with the inner surface 22 of the rigid shield 20 and being capable of ensuring a fluid and tight seal of the distal end of the medical injection device 1. Preferably, the septum 40 is made of rubber, such as butyl rubber. The septum 40 may be inserted within the rigid shield 20.

[0076] In this embodiment, the rigid shield 20 comprises an opened distal end and an opened proximal end, the flexible shield 30 comprises an opened distal end and an opened proximal end, and the septum 50 comprises a closed distal end and an opened proximal end.

[0077] In this example, the inner 32 and the outer 31 layers are separated by the rigid shield wall 21.

[0078] The wall 21 of the rigid shield 20 may comprise a first portion P1 located at the distal end of the needle shield assembly 10 and a second portion P2 being located at the proximal end of the needle shield assembly 10. The first portion P1 may comprise a first cavity C1 capable of receiving the septum 40 and said second portion P2 comprises a second cavity C2 capable of receiving the inner layer 32 of the flexible shield 30.

[0079] For example, the outer layer 31 of the flexible shield 30 has an inner surface 31 surrounding the first portion P1.

[0080] The flexible shield 30 may comprise at the proximal end of the needle shield assembly 10 ribs (not shown) configured to receive recesses (not shown) located on an outer surface of the hub portion 3 of the syringe 1.

[0081] Preferably, the rigid shield 20 comprises at the proximal end of the needle shield assembly 10 a circular groove 24 configured to receive a ring seal 60 surrounding the ribs of the flexible shield 30. The ring seal 60 may be overmpolder over the rigid shield. For example, the ring seal is made of rubber or TPE.

[0082] The needle shield assembly may comprise a RFID tag 50 located between the rigid shield 20 and the flexible shield 30, said RFID tag 50 comprising at least one RFID antenna (not shown). The RFID tag 50 may further comprise a chip connected to the antenna. The RFID tag 50 may be a chipless RFID tag, a LF-RFID tag, a HF-RFID tag or an UHF-RFIF tag, or a HF-NFC RFID tag.

[0083] Preferably, the RFID tag 50 in contact with the outer surface 23 of the wall 21 of the rigid shield 20 is surrounded by an inner surface 31 of the outer layer 31. Advantageously, the rigid shield 20 comprises grooves 35 configured to receive a part of the RFID tag 50.

[0084] Preferably, the RFID tag 50 has a width (not shown) extending between 10% and 100% of the circumference of the outer surface of the rigid shield, 100% being excluded, and advantageously between 40% and 100%, more preferably between 50 and 100%, or between 50 to 100% and advantageously between 50% and 90% of the circumference of the outer surface of the rigid shield 20. Advantageously, the RFID tag 50 has a length LT extending strictly less than 100% of a length L of the needle shield assembly 10. Preferably, the RFID tag 50 has a length LT extending over at least 15%, more preferably 25% of a length L of the needle shield assembly 10. This enables maximizing the exposition of the antenna to electromagnetic waves of a reader.

[0085] For example, the RFID tag 50 may be disposed in a mold before the injection molding of the rigid shield 20. Alternatively, the RFID tag 50 may be 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.

[0086] The needle shield according to the present invention provides a soft touch to the user and offers a constant pull-out force.