FR2698613A1 - Sterile cap for bottle with inner rubber stopper - has detachable seal disc in top which allows stopper to be pierced and removable ring which allows stopper to be extracted - Google Patents

Abstract

The cap (1), designed to fit over the end of a bottle (8) which has an elastic stopper (12) that can be pierced in the centre by a hollow needle, has an annular skirt (11) of a semi-rigid material, with an inner ridge (10) to engage with the bottle neck lip, and a removable seal disc (2) in the top. The cap is moulded in one piece from a plastic material, e.g. polyethylene or polypropylene, with the seal disc (2) surrounded by a line (3) of reduced resistance and equipped with a projection (4) by which it can be gripped and pulled off. Above the line of the inner ridge (10) the cap is equipped with a detachable strip (16) between two lines (14,15) of reduced resistance which do not extend all the way round the cap but leave a small portion which can act as a hinge. USE/ADVANTAGE - For use in medicine, e.g. for transfusions or draining wounds. Provides sterile cover for inner elastic stopper, which can be either pierced or removed.

Description

STERILE CAPPING DEVICE
INVIOLABLE FOR SINGLE USE
The present invention relates to a sterile tamper-evident closure device for single use, for locking a vial provided with a stopper made of elastic material pierceable in its central cap by a hollow needle.

 Such bottles are intended in particular for medical uses such as infusion or aspiration and drainage of wounds. Such bottles are sterilized by usual methods such as steam, or by radiation. The closure of such bottles is carried out by a rubber or polymer stopper, having a perforable zone in the central part. This plug is usually covered by a sand or screw-crimped device, ensuring the locking of the rubber plug, and having a removable cap to allow access to the central cap of the rubber plug.

 When the device is of the crimpable type, it has an annular skirt of semi-rigid material for crimping the closure device on the neck of the bottle.

 There is known in the prior art a closure capsule described in French patent No. 2,645,123 consisting of a metal capsule having a pre-rupture line delimiting a central part to be eliminated.

 This device is not entirely satisfactory because it prohibits the removal of the rubber stopper, for example to empty the contents of a drainage bottle. In addition, it requires a special tool for the lateral crimping of the annular skirt, after filling the bottle, or after placing under vacuum for the production of a drainage bottle.

 Another closure means, described in French patent No. 2516480 or French patent No. 2529531, comprises an annular plastic ring crimpable on the neck of a bottle, and has a central cap closed by a tear-off lid, for example a washer self-adhesive.

 This device implements several parts and requires a particular assembly operation of these parts leading to an increase in manufacturing costs.

 The object of the present invention is to remedy these drawbacks by proposing a clip-on closure device constituted by a single piece produced by molding of plastic material, and allowing removal of the rubber stopper after tearing off a tamper-evident band.

 To this end, the invention relates to a device constituted by a single piece molded in plastic material comprising a tear-off lid delimited by a continuous sealed rupture line, provided with a gripping protuberance, said device further comprising above the clipping shoulder an annular band delimited by two rupture lines extending over a length less than the perimeter of the annular skirt, between two rupture segments of a length corresponding substantially to the height of the annular band, said annular band having at one of its ends a gripping protuberance for tearing off the tamper-evident band.

 The device is produced in the form of a single-piece, tunic piece, without perforation of the surface situated above the clipping shoulder, in order to prevent any contamination of the rubber stopper or of the surfaces of the bottle liable to come into contact. with the content. The device according to the invention guarantees the impossibility of unclipping and removing the cap without destroying the tamper-evident band, and consequently guarantees the sterility of the percussible area. Furthermore, the device according to the invention allows the closure and the locking of the bottle without recourse to specific tools, the device being put in place by a simple axial force.

 The tightness of the device, implying in particular the continuity of the material including at the level of the rupture lines, makes it possible to guarantee the sterility of the rubber stopper.

 According to a preferred embodiment, the closure device according to the invention has a rod extending to the interior surface of the device, said rod being provided between the central cap and the annular skirt.

 This rod comes to rest on the upper surface of the rubber stopper and prevents contamination of the surface of the central zone of the stopper delimited by the rod.

 Advantageously, the rod consists of an annular edge with a diameter greater than the diameter of the rupture line delimiting the central cap.

 Preferably, the device according to the invention is produced by injection of polyethylene or polypropylene allowing the entire bottle and closure means to be sterilized by water vapor or radiation.

The invention will be better understood on reading the description which follows, referring to the appended drawings relating to a nonlimiting exemplary embodiment, where:
- Figure 1 shows a top view of the closure device;
- Figure 2 shows a view along a section plane AA ';
- Figure 3 shows a developed view of the device.

 Figure 1 shows a top view of the device according to the invention. This device consists of a single-piece piece of generally cylindrical shape, produced by molding in a single mold a plastic material such as polyethylene. It has at its upper surface (1) a central cap (2) in the form of a disc delimited by a circular breaking line (3).

 A protuberance (4) makes it possible to exert traction on the central cap (2) to tear off said central cap (2) and allow access to the perforable zone of the rubber stopper.

 For example, the outside diameter of the device is 34.6 millimeters, and the diameter of the central cap (2) is 12 millimeters.

 A side tab (6) having a central perforation (7) allows the connection of a cord, for example for the suspension of the bottle to a bracket.

 FIG. 2 represents a view of the device according to a median section plane AA '.

 The neck (8) of the bottle has an annular shoulder (9) cooperating with an annular shoulder (10) provided on the inner surface of the side skirt (11) of the device for clipping the device onto the bottle.

 The skirt extends below the shoulder (10) and has a beveled lower edge (11 ') to facilitate the positioning of the device on the bottle and guarantee the impossibility of unclipping.

 A rubber stopper (12) of known type ensures the watertight closure of the bottle.

 The central cap (2) is delimited by a breaking line (3) with a depth of between 5% and 30%, preferably of the order of 15% of the thickness of the central part (2). For example, the thickness of the upper surface (1) of the device is 1 millimeter, the thickness of the central part of 0.5 millimeters, the plane of the upper surface of the central part being raised by 0 , 2 millimeters.

 The device has an annular ring (13) between the rupture line (3) and the skirt (11). This annular ring has two edges inclined at an angle of about 60 degrees relative to normal to the upper surface (1) of the device, and comes to rest on the rubber stopper (12) to ensure partitioning between the volume inside said ring (13) and in the volume outside said ring. In the example described, the height of the rod (13) is 0.5 millimeters.

 The skirt (1 & of the device has two parallel breaking lines (14, 15) delimiting a tear strip (16) with a height of about 2 millimeters. The thickness of the skirt is reduced, at the level of the lines breaking (14, 15) to about 15% of the normal thickness.

 Figure 3 shows a view of the developed skirt. The tear strip (16) does not extend over the entire periphery, but is interrupted at a hinge (17) forming a hinge when the tear strip (16) is removed. To this end, the hinge (17) forming a hinge is delimited laterally by two breaking segments (18, 19).

 Near one end of the tear strip (16) extends a tongue (20) allowing to exert a traction for the removal of the tear strip.

For a use for closing a drainage bottle, the preparation process is as follows:
A vacuum is produced in the bottle under a vacuum bell. Then close the bottle with the rubber stopper, then clip the device to lock the rubber stopper by exerting an axial force on the device so that it automatically locks on the neck of the bottle.

 The entire bottle and its sealing means are then sterilized with water vapor or by subjecting it to radiation of known type.

 During use, the operator tears off the central cap (2) gripping the protuberance (4) and exerting traction. It thus frees the sterile perforable surface of the rubber stopper (12), the rod (13) having prohibited contamination inside the central zone delimited by said rod.

 When the operator wishes to remove the rubber stopper (12), he grasps the tongue (20) and provides traction in order to cause the tear strip (16) to rupture along the rupture lines (14, 15) . The upper part of the closure device remains connected to the skirt (11) by the hinge (17). The upper part of the device can be tilted to allow the plug to be removed, and replaced to hold the rubber plug.

 The present invention is described in the foregoing by way of nonlimiting example. It is understood that the person skilled in the art will be able to carry out different variants of execution without departing from the scope of the invention.

Claims (5)

 1 - Sterile tamper-evident closure device for single use, for locking a bottle provided with a stopper (12) made of elastic material percutable in its central zone by a hollow needle, having an annular skirt made of semi-rigid material and having an internal shoulder (10) for clipping the closure device onto the neck of the bottle, the closure device further having a central cap closed by a removable cover, characterized in that said device consists of a single piece, molded in plastic material, the tear-off cover being constituted by a central cap (2) delimited by a continuous watertight rupture line (3), provided with a gripping protuberance (4), said device further comprising above the shoulder (10) for clipping an annular strip (16) delimited by two rupture lines (14, 15) extending over a length less than the perimeter of the annular skirt (11), between d them breaking segments (18, 19) delimiting a hinge (17) of a height corresponding substantially to the height of the annular strip (16), said annular strip (16) having at one of its ends a gripping protuberance (20), the surface of the device located above the clip shoulder (10) having no breakage or perforation.  2 - sterile tamper evident closure device for single use according to claim 1 characterized in that it has a rod (13) extending to the inner surface of the device, said rod (13) being provided between the central cap (2) and the annular skirt (11).  3 - sterile tamper evident closure device for single use according to claim 2 characterized in that the rod (13) is constituted by an annular ridge with a diameter greater than the diameter of the rupture line (3) delimiting the central cap (2 ).  4 - sterile tamper-evident closure device for single use according to any one of the preceding claims, characterized in that it is produced by injection of polyethylene or polypropylene or any other material capable of ensuring the conditions of use.  5 - sterile tamper-evident closure device for single use according to any one of the preceding claims, characterized in that there is a side tab (6) provided with an orifice (7) for the passage of a suspension means.