FR2828803A1 - SAFETY PACKAGING FOR MEDICAL BOTTLE - Google Patents

Abstract

The invention relates to an economical packaging device that is intended for a bottle for medical use. The inventive packaging device is easy to produce and meets objectives both in terms of safety of personnel and protection against breakage. Said device comprises a one-piece cylindrical plastic body consisting of two parts which are separated by a partition (12), said partition being disposed perpendicularly to the axis of the tubular body. The lower part (B), which is intended to cover the glass bottle (1) completely, may comprise means (9) on the base thereof for stabilising the device in the vertical position. The second upper part is provided with a smaller diameter and consists of a cylindrical chamber (A) containing means, e.g. a double-pointed needle (10, 11), for transferring the contents of the bottle (1) into a container, such as an infusion bag (6).

Description

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SAFETY PACKAGING FOR MEDICAL BOTTLE
The present invention relates to a safety packaging for a vial for medical use, in particular for a vial containing substances potentially dangerous for users or the environment (anticancer, antibiotics, etc.).

 These medicinal substances are generally packaged in glass bottles sealed with a perforable elastomer stopper, itself fixed in a tamper-proof manner on the bottle by crimping an aluminum cap. These drugs can be in the form of a liquid, a powder or a lyophilisate.

They are intended to be transferred to an infusion bag containing an infusion liquid (NaCl, glucose, etc.) and then to be injected into the patient. The drugs stored in the vial in the form of a liquid can be directly transferred to the infusion bag, those in the form of a powder or a lyophilisate must first be reconstituted by dissolving in a solvent.

 The risks associated with the daily handling of these drugs in glass vial are of three orders for the nursing staff: - risk of accidental injection during transfer or reconstitution operations using a syringe fitted with a non-needle protected, - risk of glass bottles breaking during handling or transport.

 - Risk of drug leakage during reconstitution.

 In the case of accidental breakage of a vial containing an anticancer drug, or leakage of the drug, the decontamination procedure put in place is extremely cumbersome and costly, especially in the case where a pregnant woman has been in contact with the

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 widespread drug (impact on fetal growth).

 For a certain number of active substances, it is not possible to use plastic bottles and the risk of breakage of the bottle is a major problem.

 The object of the present invention is therefore to provide a device offering the best guarantees of security with regard to both the risk of breakage of the bottle, the risk of accidental puncture and the risk of leakage.

 Devices are already known which reduce the risk of accidental injection.

 Patent FR1380706 describes a device for transferring a container into another consisting of a plate crossed by two hollow pointed needles at their two ends.

 The patent FR1545963 describes a transfer device constituted by a hollow cylinder provided with a stop diaphragm traversed by a perforated needle comprising two points.

 Patent FR2302134 describes a device for transferring the liquid content of a container through the stopper or the lid thereof into a second container comprising a tubular body covering the necks of the two containers, a hollow needle having two pointed ends d 'a sufficient length to pass through the plugs or lids of the containers and another hollow needle, one end of which passes through the plug or lidding of one of the containers and the other end remains in communication with the atmosphere.

 The patents EP0192661 and EP0195018 describe devices for the reconstitution of drugs making it possible to connect a vial of powder and an infusion bag using a twin-pointed needle and

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 having means for preventing accidental separation of the elements.

 Patent FR2780878 describes a transfer cap for the passage of a medicament between a vial and a solution bag comprising a one-piece tubular body and a needle, characterized by particular latching means.

 The documents EP0850178, EP1006981, WO0016730 and FR2789369 describe connection devices between a closed container and a container in the form in particular of ready-to-use assemblies.

 These various devices are either pre-mounted by clipping on the neck of the bottle, or are delivered separately, preferably in a sterile blister, and clipped on the bottle by the nursing staff.

 The ready-to-use systems are simpler to handle and they avoid the risk of contamination when clipping onto the bottle; however, they are expensive and do not solve the problem of breaking glass bottles.

 The present invention makes it possible to obtain a cheap transfer device, easy to manufacture and meeting both the objectives of personnel safety and protection against breakage.

 The device which is the subject of the present invention is a cylindrical monobloc body made of plastic material consisting of two parts: a lower part intended to completely cover the glass vial and possibly comprising at its base means for stabilizing the device in a vertical position and an upper part of smaller diameter constituted by a cylindrical chamber containing means, for example a twin-point needle, allowing the transfer of the contents of the bottle into a container, such as an infusion bag.

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 The accompanying drawings will illustrate the present invention in more detail.

 Figure 1 is a sectional view of a standard vial containing a powdered drug.

 Figure 2 is a view of a standard infusion bag filled with solution for injection.

 Figure 3 is an axial sectional view of the packaging device according to the present invention with a bottle in the "storage" position.

 Figure 4 is an axial sectional view of the packaging device according to the present invention with a bottle in the "use" position.

 Figure 5 is a partial sectional view of a particular embodiment of the stop means preventing inadvertent drilling of the plug.

 Figure 6 is a view of a particular embodiment of the base of the device.

 FIG. 1 represents a standard glass bottle (1) closed by an elastomer stopper (2) fixed to the bottle by an aluminum cap (3). The vial contains a medicine in the form of a powder or a lyophilisate (4). But it can be a sterile liquid.

 FIG. 2 represents a standard infusion bag (6) provided with an injection site (5), intended for the transfer of the drug.

 FIG. 3 represents a device constituted by a one-piece tubular body comprising a partition (12), perpendicular to the axis of the tubular body, which delimits two open chambers (A) and (B).

 The partition (12) which constitutes the base of the chamber (A) is provided with means for holding in place a twin-pointed needle (10,11). The height of the cylindrical chamber (A) is chosen so as to completely protect the point (10) of the needle. The internal diameter of the chamber (A) is less than

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 that of the chamber (B) but sufficient to accept the passage of the injection sites (5) equipping the infusion bags.

 The twin-point needle (10, 11) can be held in the partition (12) by any suitable means, such as gluing, welding, overmolding.

 The chamber (B) into which the other end (11) of the twin-point needle opens out consists of a tube (13). This chamber (B) is intended to cover the bottle (1). The diameter of the tube (13) is therefore chosen so as to be able to insert the bottle (1) into the tube. Thus, the diameter of the tube (13) is slightly greater than the diameter of the body of the bottle (1).

Preferably, the tube (13) is narrowed at its upper end to form a tube (13a) with a diameter less than that of the tube (13), the diameter of the tube (13a) being slightly greater than the diameter of the cover (3 ) from the bottle. The diameters are chosen so as to allow the insertion of bottles of slightly different dimensions. The height of the tube (13a) is chosen as a function of the height h stopper (2) cover (3) of the bottle (1).

 This embodiment comprising a tube (13) and a tube (13a) allows to conform to the shape of the bottle (1) by improving the connection between the bottle (1) and the tip (11).

 This better connection ensures optimal positioning of the device on the bottle, thus allowing the needle to perforate the stopper (2) of the bottle in the best conditions, which prevents leaks at this level. This leakage problem is quite common with devices sold separately. Indeed, when the nurse connects the bag-dispositifflacon assembly, she shakes the assembly strongly in order to accelerate the dissolution of the drug, so if the vial is not perfectly secured to the device, it

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 a shearing phenomenon occurs which promotes the occurrence of leakage.

 The wall of the tube (13) covering the bottle can be full or have recesses over part or all of the height.

 In FIG. 3, the bottle is kept in the storage position using retaining means (8) intended to prevent the bottle from leaving the chamber (B) and retaining means (7) intended to prevent piercing. untimely cap.

 The retaining means (8) are sufficiently elastic to allow the force to be introduced into the device. One can use for example a continuous annular bead or not. In an embodiment which is not exemplified, these retaining means consist of axial ribs formed inside the tube (13) which provide a friction force on the body of the bottle. In addition, by varying the thickness of these ribs, the device can be used for bottles having slightly different diameters. As a variant, the retaining means (8) can be replaced by a thumb-perforable cover (film or welded paper) or by a captive plug.

 The retaining means (7) can be formed by any means capable of ensuring an elastic stop function, for example a continuous annular bead or not.

 Preferably, the tube (13) has at its base means intended to increase the stability of the device in the vertical position. This is for example a flange (9), possibly comprising additional means, for example flats, to prevent the device from rolling when it is in a horizontal position.

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 The tubular monobloc body is made of an impact-resistant plastic material, to avoid the risks of breakage, and preferably transparent to allow the reading of the information mentioned on the body of the bottle and the monitoring of its content. Any plastic material having such properties can be used, such as polypropylene, polycarbonate or K resin.

 In FIG. 4, the content of the bottle (1) is placed in communication with the content of the infusion bag (6) after puncturing of the stopper (2) by the tip (11) and of the injection site (5) by the tip (10).

 The bottle (1) slides in the chamber (B) under the action of a thrust exerted on the bottom (14) of the bottle. The bottle moves until it comes up against the partition (12), which allows the tip (11) to pierce the stopper (2). Preferably, a push is exerted on the bottom (14) of the bottle using the thumb.

 The retaining means (7) make it possible to keep the bottle in the use position and to avoid the axial movement of the bottle down.

 The injection site (5) of the infusion bag (6) is pierced in a conventional manner by forcefully introducing the site into the chamber (A).

 FIG. 5 represents a particular embodiment of the stop means (7) preventing untimely drilling of the plug. In this embodiment, the elastic retaining means consist of tongues (15, 16) whose free ends are oriented towards the inside of the tube (13a). Thus, the thrust exerted on the bottom of the bottle spreads the tabs (15, 16) which, after piercing the stopper (2), prevent the bottle from falling back towards the bottom of the device.

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 The elastic means (8) can also consist of tongues such as the tongues (15, 16).

 FIG. 6 represents a particular embodiment of the base of the device. In this embodiment, the base of the tube (13) has one or more openings (17) intended to facilitate the pushing on the bottom of the bottle. We prefer systems with only one opening to avoid the risk of pulling out of the bottle.

 The figures illustrate an embodiment in which a bottle (1) and an infusion bag (6) are placed in communication. However, the system can be used to port a vial to another type of container.

 The exemplified embodiments relate to a device with a twin-pointed needle, but it is also possible to use a device with a needle on the bottle side and a Luer site on the pocket side.

 The device according to the invention is a one-piece plastic body. It is therefore easy to produce by implementing the conventional processes of the plastics industry.

 In addition, in order to ensure a sterile mode of implementation, the device is sterilized with ethylene oxide, by steam or by radiation.

 Preferably, the device is placed in advance on the bottle (1). The device / bottle assembly is preassembled, placed in a blister and sterilized as above.

 In variant 1, the device can be provided with a removable stopper sealingly sealing chamber A, then after mounting the bottle in chamber B the bottom of chamber B can be sealed with a "heat-sealable" paper, allowing sterilization of the whole with ethylene oxide or steam. This

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 variant avoids blistering the device-bottle assembly. During use, the nurse removes the cap, then pushes the bottle through the paper, which will tear effortlessly.

 According to another variant, the device is placed on the bottle (1) at the time of its use. Just remove the cap (3) and forcefully insert the bottle into the tube (13).

 The description and the figures are an illustration of various embodiments of the present invention. The invention is not however limited to the embodiments described and shown, but on the contrary covers all variants.

Claims (11)

1-Device for packaging a vial for medical use (1) comprising: - a cylindrical tubular body, - a partition (12) perpendicular to the axis of the tubular body

 defining two open chambers (A) and (B), provided with means for holding in place means for transferring the contents of the bottle (1) into a container, such as an infusion bag (6), characterized in that the cylindrical tubular body completely covers the bottle (1).  2-A device for packaging a vial for medical use according to claim 1, characterized in that the chamber (B) is constituted by a tube (13) comprising means (7,8) intended to prevent the axial movement of the vial (1) during storage or handling, but sufficiently elastic to allow the introduction of the bottle into the device (means 8) and the axial movement of the bottle (means 7) towards the transfer means under the action of a push exerted on the bottom (14) of the bottle (1).  3-Device for packaging a vial for medical use according to one of claims 1 to 2, characterized in that the means for transferring the contents of the vial into an infusion bag (6) consist of a twin needle tip (10,11).  4-Device for packaging a vial for medical use according to one of claims 1 to 2, characterized in that the means for transferring the contents of the vial into an infusion bag (6) <Desc / Clms Page number 11>  consist of a needle on the side of the bottle (1) and a male or female Luer site on the side of the pocket (6).  5-Device for packaging a vial for medical use according to one of claims 2 to 4, characterized in that the tube (13) is narrowed at its upper end by forming a tube (13a) of diameter slightly smaller than that of the tube (13).  6-A device for packaging a vial for medical use according to one of claims 1 to 5, characterized in that the elastic means (7,8) consist of a continuous annular bead or not.  7-A device for packaging a vial for medical use according to one of claims 1 to 5, characterized in that the elastic means (7,8) consist of tabs (15,16) whose free ends are oriented towards the inside of the tube (13).  8-Device for packaging a vial for medical use according to one of claims 1 to 7, characterized in that the base of the tube (13) is equipped with a collar (9), optionally provided with means intended to prevent the device to roll in a horizontal position.  9-A device for packaging a vial for medical use according to one of claims 1 to 8, characterized in that the base of the tube has one or more openings (17) intended to facilitate the pushing on the bottom of the vial.  10-Device for packaging a vial for medical use according to one of claims 1 to 9, <Desc / Clms Page number 12>  characterized in that the tubular body is made of shockproof and transparent plastic.  11-Device for packaging a vial for medical use according to one of claims 1 to 10, characterized in that the device is sterilized in its packaging with ethylene oxide, steam or by radiation.