US-12623024-B2 - Syringe with Luer-lock connector provided with a tamper-proof cap

US12623024B2US 12623024 B2US12623024 B2US 12623024B2US-12623024-B2

Abstract

A syringe including a hollow cylindrical body containing a product to be injected and from which there extend a hollow tip equipped with a Luer-lock connector and a plunger, sliding inside the hollow cylindrical body; and a tamper-proof cap including a closure cap and a tamper-proof insert, where the closure cap includes a portion for coupling with the Luer-lock connector and a handle portion. An external seat for housing the tamper-proof insert is formed in the handle portion of the main body of the closure cap. The tamper-proof insert includes at least one longitudinal section, a transverse section and a terminal element, which is connected to a free end of the longitudinal section by a frangible connection, the terminal element configured to be immovably housed in a corresponding groove formed on an external surface of the Luer-lock connector. The tamper-proof insert is immovably coupled to the closure cap.

Inventors

Alfredo Ricci

Assignees

Platinum Pharma Service S.r.l.s.

Dates

Publication Date: 20260512
Application Date: 20220502
Priority Date: 20210505

Claims (19)

1 . A syringe, comprising: a hollow cylindrical body containing a product to be injected and from which a hollow tip equipped with a Luer-lock connector extends, and a plunger configured to slide inside the hollow cylindrical body; and a tamper-proof cap comprising a closure cap and a tamper-proof insert, wherein the closure cap includes a portion for coupling with the Luer-lock connector and a handle portion; wherein an external seat for housing the tamper-proof insert is formed in the handle portion of the closure cap, wherein the tamper-proof insert comprises at least one longitudinal section, a transverse section and a terminal element which is connected to a free end of the longitudinal section by a frangible connection, the terminal element configured to be immovably housed in a corresponding groove formed on an external surface of the Luer-lock connector, and wherein the tamper-proof cap further comprises means for the unmovable coupling of the tamper-proof insert and the closure cap.
2 . The syringe according to claim 1 , wherein the unmovable coupling means comprises at least one element for the unmovable coupling to the handle portion of the closure cap, wherein the at least one coupling element extends from the transverse section of the tamper-proof insert towards the inside of the tamper-proof insert, in order to be coupled by interference with a corresponding cavity of the closure cap, which extends towards the inside of the handle portion of the closure cap.
3 . The syringe according to claim 2 , wherein at least the at least one unmovable coupling element is wedge-shaped or the corresponding cavity of the closure cap has slightly inclined walls.
4 . The syringe according to claim 2 , wherein the unmovable coupling means comprise at least one hooking element which extends from the transverse section of the tamper-proof insert towards the inside of the tamper-proof insert, in order to be snap-fittingly housed in a corresponding cavity of the closure cap, which extends towards the inside of the handle portion of the closure cap.
5 . The syringe according to claim 4 , wherein the hooking element has a terminal tooth configured to be snap-fittingly housed in a corresponding transversely projecting section of the cavity, thereby providing an unmovable coupling between the tamper-proof insert and the closure cap.
6 . The syringe according to claim 1 , wherein the tamper-proof insert comprises two longitudinal sections which are connected therebetween by the transverse section and a pair of terminal elements, each connected to a free end of a respective longitudinal section by a frangible connection, wherein the terminal elements are configured to be housed in corresponding grooves formed on the external surface of the Luer-lock connector.
7 . The syringe according to claim 1 , wherein the at least one unmovable coupling element comprises a pair of unmovable coupling elements, suitably spaced therebetween and each immovably housable in a corresponding cavity of the closure cap.
8 . The syringe according to claim 1 , wherein the at least one unmovable coupling element comprises two pairs of unmovable coupling elements, wherein the unmovable coupling elements of each pair are opposed and suitably spaced therebetween, each pair of unmovable coupling elements immovably housable in a corresponding cavity of the closure cap.
9 . The syringe according to claim 1 , wherein the unmovable coupling means comprises a layer of glue applied between the tamper-proof insert and the closure cap.
10 . The syringe according to claim 1 , wherein the unmovable coupling means comprises welding points or continuous welding applied between the tamper-proof insert and the closure cap.
11 . The syringe according to claim 1 , wherein the frangible connection between the free end of each longitudinal section and the respective terminal element of the tamper-proof insert comprises a narrowing having a smaller section than that of the transverse section and the terminal element of the tamper-proof insert.
12 . The syringe according to claim 1 , wherein each groove of the Luer-lock connector has side and bottom walls, each of which are inclined towards the inside of the groove and a chamfered inlet open end, opposite to the bottom wall.
13 . The syringe according to claim 6 , wherein each terminal element of the tamper-proof insert has tapered edges which, when the terminal elements are inserted into the grooves of the Luer-lock connector, cooperate with the corresponding inclined side and bottom walls of the grooves.
14 . The syringe according to claim 1 , wherein an annular surface, which is designed to come into abutment against a corresponding annular surface of the Luer-lock connector, is delimited between the handle portion and the coupling portion of the closure cap.
15 . The syringe according to claim 1 , wherein the tamper-proof cap further comprises a rubber housed in an axial cylindrical cavity of the closure cap, wherein the rubber has a first surface, a second surface opposite to the first surface and facing an opening of the axial cylindrical cavity so as to abut, in use, against a free end of the hollow tip of the syringe, and a side surface.
16 . The syringe according to claim 15 , wherein at least one longitudinal groove is formed at the side surface of the rubber.
17 . The syringe according to claim 15 , wherein the first surface of the rubber is plane or convex with convexity facing the hollow tip of the syringe.
18 . The syringe according to claim 1 , wherein two recesses are further formed in the handle portion, and the recesses extend substantially for the entire length of the handle portion and are arranged on opposite sides with respect to the external seat for housing the tamper-proof insert.
19 . The syringe according to claim 1 , wherein the tamper-proof insert has a different colour from that of the closure cap.

Description

TECHNICAL FIELD The present invention relates, in general, to the technical field of the syringes with Luer-lock connector. More particularly, the present invention relates to a syringe, preferably of the pre-filled type, with Luer-lock connector equipped with a tamper-proof cap. BACKGROUND Syringes, in particular those pre-filled, are widely used to inject, in a person, medicinal products such as, among others, anticoagulants, for example heparin and the like, vaccines, small sized molecules, and cosmetic products, for example hyaluronic acid. They represent a growing market, as they make it possible to effectively reduce errors in the dosage of a product to be injected and contribute to reduce packaging costs. A syringe typically comprises a transparent cylindrical body, on which measurement marks are shown, a plunger sliding inside the transparent cylindrical body and a hollow and frusto-conical tip, extending from the transparent cylindrical body and onto which a needle, it also being hollow, is then fitted through which the product to be injected contained in the hollow cylindrical body passes. The plunger is provided, at one of the ends thereof, with a rubber ring or capsule to ensure the controlled and constant sliding of the plunger inside the transparent cylindrical body. The tip of the syringe can be provided with a Luer-lock connector, i.e. a screwing system that locks the needle connection to prevent the unintentional removal thereof. Finally, the syringe is provided with a closure cap, the main function of which is to prevent the product contained in the syringe from leaking. The closure caps of the syringes with Luer-lock connector, in addition to having sealing properties, i.e. ensuring air tightness, and anti-screwing properties, i.e. being configured so that they do not accidentally and undesirably separate from the syringe when the syringe is not in use, typically during syringe storage, must also ensure that the product contained in the syringe is not tampered with, either accidentally or intentionally, prior to use. In fact, it is essential that the closure cap is only removed from the syringe when it is being used by a healthcare professional to inject a person with the product contained in the syringe. This is done in order to preserve the product, avoiding the introduction or removal of substances other than those with which the syringe is e.g. pre-filled during production, into/from the syringe during transport and storage thereof. A syringe provided with a tamper-proof cap is disclosed in the patent document no. U.S. Pat. No. 5,135,496. The syringe comprises a hollow body having a neck centred on an axis, an elastomeric cap, which is inserted into the neck and having an end projecting axially from the neck, and a stiffening sleeve, which is mounted on the cap and on the neck and having a collar mounted around the projecting end of the cap and itself projecting axially forward with respect to the cap. The syringe also comprises an elastomeric cap, which is inserted into the collar, a protective cap, which is mounted on the sleeve and on the cap and having a rear terminal edge, and a ring, which is snap-fittingly fixed on the sleeve and having a front terminal edge facing the rear terminal edge of the protective cap. The rear terminal edge of the protective cap and the front terminal edge of the ring fixed to the sleeve are connected therebetween by a frangible connection, so that the cap is held in place on the syringe body. The cap is thus only removable from the syringe body after the frangible connection has been broken. However, the tamper-proof syringe system described above has some drawbacks. In particular, this known system is not able to guarantee to the healthcare professional the total absence of tampering with the cap, and therefore the integrity of the product contained in the syringe. In fact, due to the presence of the snap-fitting coupling between the ring, to which the protective cap is connected by the frangible connection, and the sleeve which is mounted on the hollow body of the syringe, it is sufficient to elastically deform the ring to release the latter, and with it the protective cap, from the syringe, and this without breaking the frangible connection between the sleeve and the protective cap. Therefore, when using the syringe, the healthcare professional may not notice that the tamper-proof system has been violated. Other syringes with tamper-proof cap of the known type include the presence of micro-welds between the cap and external portions of the hollow cylindrical body, or of the Luer-lock connector, of the syringe. Even these known tamper-proof caps, although structurally and functionally simple, do not guarantee to the healthcare professional the total absence of tampering, and therefore the integrity of the product contained in the syringe. In fact, a third party, by using special tools, could remove the micro-welds between the tamper-proof cap and th