HK1050131A - Device for connection between a vessel and a container and ready-to-use assembly comprising same - Google Patents

Description

Device for connecting a receptacle to a container and ready-to-use assembly comprising such a device

The invention relates to a device for connecting a closed receptacle to a container. It also relates to a ready-to-use assembly comprising a closed receptacle and a connecting device of the aforementioned type.

In the field of pharmaceutical packaging, it is known to store a component of a pharmaceutical preparation, for example its active ingredient, in a receptacle closed by a plug made of a relatively soft material, such as synthetic rubber. When the stopper is pierced, liquid is injected into the receptacle to dissolve the components contained in the receptacle or to place them in suspension, so that the preparation, in particular a medicament or vaccine, is obtained in liquid form and is ready for administration to a patient.

WO-A-97/10156 discloses A coupling device comprising A base adapted to cover the neck of A receiver and to extend A flange or sleeve to form an internal bore in which A piston is mounted for sliding movement. The piston is provided with a needle for piercing the stopper of the receptacle at a so-called transfer position. This device is satisfactory, in particular, if equipped with a luer connector, it allows the use of syringes.

However, certain products, such as those used in cancer chemotherapy and formulations containing cytotoxic molecules, are packaged in a receptacle and do not necessarily correspond to a single dose administered to a patient. Therefore, the nursing staff must perform a divided dosing operation of the product in question, that is to say, a plurality of administrations. Because of their toxicological properties, these products must be handled with great care and without exposure to the care giver.

Care must be taken to install A one-way valve in the known WO-A-97/10156 device to prevent liquid in the receptacle from flowing to the outside. However, such a device may result in additional handling by the caregiver, with the risk of malfunction in order to secure the valve on the device when the medicament is prepared. In addition, there may be a risk of premature disconnection of such a valve on the device, which proves to be dangerous when the piston of the syringe is pulled in order to suck up the liquid in the receptacle, in the case of a receptacle above the syringe. In fact, in that case, possible leaks at the interface between the piston and the valve could lead to a toxic flow onto the hands of the nursing staff. In addition, the space required for mounting such a valve on the piston of the known device prevents the cap of the device from protecting the piston and the internal bore in the base between the two samples of product, which also increases the risk of contamination, in particular in the hospital environment.

The object of the present invention is to solve these problems by providing a novel coupling device which, when the piston is pushed into a position to pierce the stopper of the receptacle, effectively seals the interior of the receptacle from the surrounding atmosphere and does not require the use of additional valves which may cause leakage and/or interfere with the operation of the device.

To this end, the invention relates to a device of the aforementioned type, the piston of which is provided with a valve for controlling the flow of liquid into or out of the interior of the receptacle, this valve being integrated as part of the piston for providing a connection between the needle on the piston and the container.

With this invention, the valve forming the one-way valve is permanently placed on the piston without the risk of premature disconnection, and therefore the risk of leakage is limited. Since it is integrated as part of the piston providing the connection to the container, this valve does not directly modify the dimensions of the piston, the advantage of which is crucial in terms of the total space required for the device.

According to an advantage of the invention, the device comprises one or more of the following features:

a valve comprises a valve body integral with a piston and a flap valve controlled by the valve body. In that case, the valve body conveniently forms an internal shoulder adapted to abut a bearing surface or portion of the flap valve. This internal shoulder serves to limit the movement of the flap valve and to close the liquid flow passage or the passage in the valve. According to a preferred embodiment, the inner shoulder may penetrate superficially into a support portion provided on the flap valve.

The valve comprises a flap valve which is resiliently deformable at least in a direction parallel to the displacement of the piston within the bore.

The flap valve is provided with a longitudinal groove coordinated with the inner surface of the valve body, i.e. a circulation channel for the liquid to flow in or out inside the receptacle. In this case, the flap valve advantageously comprises a circumferential groove, so that it is divided into two pieces in which the longitudinal groove is made.

The flap valve comprises two end sections having a diameter greater than the nominal diameter of the intermediate section located between the two end sections.

The groove or the intermediate section can be deformed under the influence of the pressure to which the flap valve is subjected.

The flap valve is symmetrical about its median cross-section.

The valve comprises a valve body provided with means for connecting the container, the valve body being adapted to receive a portion of the container which is to interact with the flap valve of the valve. In this case, the valve body is adapted to receive a male luer connector attached to the container which allows the flap valve to be operated by applying a force directly on the piston.

-a cap for protecting and isolating the piston from the ambient air is mounted on the base, protecting and isolating the valve, independently of the position of the piston. Due to this feature of the invention, the cap can be placed before and after the first use of the device, especially in view of protecting the device in case of multiple use of a divided dose with a view to subsequent use.

The invention also relates to a ready-to-use assembly comprising a closed receptacle containing a product, in particular a pharmaceutical preparation, the receptacle being provided with a neck, the opening of which is blocked by a plug, and a connecting device such as the one described above mounted on the receptacle. Such an assembly makes it possible to preserve the components of a medicament or vaccine, in particular its active ingredients, in a sterile manner and to prepare them by mixing them with a liquid when required, in divided doses, possibly without the risk of leakage.

The invention may be more readily understood and other advantages will become more apparent and more readily appreciated after reading the following description of two embodiments of the coupling device made in accordance with the principles thereof, given by way of example only and with reference to the accompanying drawings, in which:

fig. 1 is an exploded side view of a ready-to-use assembly according to the invention, and a syringe intended to cooperate with this assembly.

Fig. 2 is an axial section of the device mounted on the assembly shown in fig. 1, in a stored state.

Fig. 3 is a view similar to fig. 2, in a state in which a syringe is used to inject liquid into the receptacle.

Fig. 4 is a view similar to fig. 3, with the receiver inverted and the syringe removed.

Fig. 5 is a perspective view with the piston of the device shown in fig. 1-4 partially broken away.

Fig. 6 is a longitudinal section of a piston of a device according to a second embodiment of the invention, the valve integrated therein being in the blocking condition.

Fig. 7 is a view similar to fig. 6 with the valve open.

Fig. 8 is a view similar to fig. 5 of the piston of fig. 6 and 7.

The device 1 according to the invention has a dual function. On the one hand, it allows the tamper-proof nature of the receptacle 2 to be ensured, for example containing a product (not shown) and a glass bottle previously closed or blocked. The product may be a powder comprising an active ingredient of a medicament, for example a cytotoxic molecule for use in the treatment of cancer in chemotherapy. It may also be any other type of pharmaceutical preparation.

On the other hand, the device 1 makes it possible to ensure or establish a sealed connection between the interior of the receptacle 2 and the interior of another container, such as a syringe 3, containing a liquid for dissolving or bringing into suspension the product contained in the receptacle 2. Instead of a syringe, the container may be formed as a flexible bag or other glass vial.

The glass bottle 2 comprises a neck 4, the opening 4a of which is blocked by a stopper 5 made of a relatively soft material, such as an elastomer, preferably rubber. According to a variant of the invention (not illustrated), a capsule may be arranged around the stopper 5 and the outer annular portion 4b of the neck 4. The stopper 5 comprises a solid cylindrical core 5a adapted to fit flexibly and sealingly within the opening 4a, and a flattened portion 5b overlying the portion 4b and which may be covered by a cap.

The device 1 comprises a base made of injection-moulded plastic material, for example polyethylene and/or polypropylene, mounted around the parts 4 and 5. The base 10 comprises a substantially cylindrical sleeve 11 centred on the axis of symmetry X-X' of the parts 2, 4 and 5. The sleeve 11 is attached to an annular portion 12, which annular portion 12 is provided with a ring 13 of pointed profile intended to superficially penetrate the upper or exposed surface 5c of the stopper 5. In the opposite direction to the sleeve 11, the portion 12 extends with a plurality of elastic retaining rings 14, each having a beak 15 suitable for cooperating with the outer surface of the neck 4 in order to elastically clamp the substrate 10 on said neck.

The internal volume of the sleeve defines a bore a within which a piston 20 is slidable, the piston being formed from two sheets of injection moulded plastics material. The first plate 21 forms a hollow needle 22, which is formed by two channels 22a and 22b, which can pierce the stopper 5, passing through the central opening 12a of the annular portion 12, when the piston 20 is moved upwards in contact with the stopper 5. Channel 22a is connected to a cylindrical central chamber 23 and channel 22b is connected to an annular chamber 24 in which a hydrophobic filter 25 is placed. The chamber 24 is located between the sheet 21 and the second sheet 26 and forms part of the piston 20, fixed to the sheet 21 by any suitable means, in particular by welding and gluing.

The tab 26 comprises an annular edge 26a which surrounds the tab 21, this edge 26a being adapted to slide along the inner surface 11a of the sleeve 11. The inner surface of the sleeve 11 and the outer surface of the edge 26a may be shaped so that they constitute a groove for guiding the movement of the piston 20 inside the hole a.

The sheet 26 also comprises a central portion 26b which delimits the chamber 24 in cooperation with the sheet 21 and has a pierced hole 26c in its upper side for venting the chamber 24.

The opposite portion 26b is opposite the edge 26a and the sheet 26 also comprises a sleeve 26d integral with the body of the sheet 26 and centred on the axis X-X'.

A substantially cylindrical flap valve 27 is disposed inside the sleeve 26 b. The flap valve 27 is made of a relatively flexible material such as synthetic rubber, for example rubber. The sleeve 27 comprises two pieces 27a and 27b separated by a portion 27c having a smaller diameter than the pieces 27a and 27 b. In other words, between the blocks 27a and 27b, at the level of the portion 27c, a circumferential groove 27d is provided. The groove 27d may be deformed in the event of axial compression of the flap valve 27.

The flap valve 27 is symmetrical about its median cross section P, which is perpendicular to the axis X-X' and passes through the centre of the recess 27d, with the result that the flap valve can be mounted in the sleeve 26d in both directions. This simplifies assembly of the flap valve 27 in the piston 20, since there is no special position before the flap valve is placed in the sleeve.

On the outer surface of the blocks 27a and 27b there are provided longitudinal grooves 27e, which are substantially parallel to the axis X-X'. At the end of the flap valve 27 there are also two spikes 27f and 27g, the spike 27g resting on the flap 21 at the level of the bin 23. The diameter of the cusps 27f and 27g is smaller than the diameter of the blocks 27a and 27b, with the result that shoulders 27h and 27i are formed between these blocks and these cusps.

The inner surface of the sleeve 26e also presents a shoulder 26f against which a shoulder 27h of the flap valve 27 can abut.

The dimensions of the sleeve 26d and the flap valve 27 are chosen such that, in the absence of external stress, the shoulder 27h of the valve 27 abuts the shoulder 26f of the sleeve 26d, as shown in figures 2, 4 and 5. In this case, the groove 27e of the block 27 is closed by the shoulder 26f and the valve V formed by the parts 26f and 27 is not opened.

An outer sleeve 30 is provided to fit over the base 10 and piston 20 of the receiver 2. The sleeve 30 comprises A ring 31 for securing the ring 14 in position around the neck 4, in accordance with the teachings of the specification of WO-A-97/10156.

The ring 31 is connected to a cap 33 by a frangible element 32, the cap 33 isolating the base 10 and the piston 20 from the surrounding atmosphere as long as the frangible element is not broken. It should be noted that the height h of the cap 33 is sufficient to also cover the valve V without interfering therewith.

The operation is as follows:

to inject liquid into the interior of receptacle 2, cap 33 is removed by reducing member 32 and piston 20 is moved to its transfer position, fig. 3, where needle 22 pierces stopper 5. Next, the luer connector 3a of the syringe 3 is inserted into the sleeve 26d of the valve V, while a screw cap 3b is screwed onto the outer edge 26g of the sleeve 26 d. The sleeve 26d constitutes the female luer connector of the connector 3 a. By tightening the nut 3d, the connector 3a is pushed in the direction of the plate 21 of the piston 20, which is pushed by the pressure F1 exerted on the plate valve 27, as a result of which its shoulder 27h moves away from the shoulder 26F. Thus, liquid can flow through one central recess 27j of the cusp 27f and then through the grooves 27e of the block 27a in the direction of the grooves 27d, the liquid being distributed between the grooves 27e of the block 27b before it is distributed again around the cusp 27g and then through the central recess 27k of this cusp in the cartridge 23. The valve V is then opened. Liquid can be injected into the receptacle 2 from the silo 25.

In the position of fig. 3, in order to fix the piston in the delivery position, the retaining ring 21A of the flap 21, provided with the beak 21b, engages the edge 12b of the opening 12A, as described in reference to WO-A-97/10156.

When a sufficient amount of liquid is injected into the receptacle 2, it is possible to shake in order to mix the product contained in the receptacle 2 with the liquid to obtain the desired solution or suspension. The mixture can then be aspirated from the receptacle 2 using the syringe 3.

When a sufficient amount of product has been sucked out, although the receptacle 2 may not be completely emptied, it is possible to release the nut 3b and withdraw the connector 3a from the sleeve 3 to access the product contained in the syringe. By withdrawing the connector 3a from the sleeve 26d, as shown in fig. 3, the force F1 acting on the flap valve 27 is relaxed. Due to the relaxation of this force and the effect of its own elasticity, the flap valve 27 returns to the condition shown in fig. 2, in which its shoulder 27h abuts against the shoulder 26f of the sleeve 26d, which results in the closure of the valve V. The inner space of the receptacle 2 is thus isolated from the surrounding air and the receptacle 2 can be inverted, as shown in fig. 4, without the risk of leakage of potentially toxic compounds.

In this position, there is no risk of liquid escaping through the passage 22b of the needle 22, since the hydrophobic filter 25 only allows air to pass.

During the injection of the liquid into the receptacle 2, the channel 22b, the bin 24 and the hole 26c allow the evacuation of air without the risk of creating too much pressure inside the receptacle 2. The risk of spillage, particularly when the connector 3a exits the sleeve 26d, is thus limited.

In the second embodiment shown in fig. 6-8, like parts from the first embodiment have been given the same reference numerals increased by 100.

The device 101 of this embodiment comprises a piston 120 formed by two rigid, hermetically sealed assembled pieces 121 and 126, between which an annular chamber 124 is formed, in which a hydrophobic water filter 125 is placed. Sheet 121 also defines a hollow needle 122 having a first passage 122a connected to central chamber 123 and a second passage 122b connected to chamber 124.

As in the first embodiment, the cartridge 124 is provided with an aperture 126c in the sheet 126, similar to a sleeve 126d integral with the body of the sheet 126.

The sleeve 126d is centered on the X-X' axis, which is also the central axis of the plates 121 and 122 and the central axis of the piston 120 sliding in a bore in a base (not shown) of the type described for the base 10 in the first embodiment.

Inside the sleeve 126, a flap valve 127 made of elastomer is mounted, with two spikes 127f and 127g, like the spikes 27f and 27g of the first embodiment. Between the two cusps 127f and 127g, the flap valve 127 has two sections 1271 and 127m, the diameter d1 of which is greater than the diameter d2 of the median section 127n between the sections 1271 and 127 m.

The sleeve 126d is provided with an inner shoulder 126f of angular cross-section, and the inner diameter d3 of the sleeve 126d is smaller than the diameter d1 at the height of the shoulder 126f, with the result that the shoulder 126f can abut and superficially pierce the cross-section 1271 of the flap valve 127, which ensures that the flap valve 127 rests sealingly on the shoulder 126 f. In practice, the internal dimensions of the sleeve 126d and the dimensions of the flap valve 127 are chosen so that in the absence of stress, the flap valve assumes the state shown in fig. 6.

When liquid is injected into a receptacle of the type such as the receptacle 2 of the first embodiment, on which the device 101 containing the piston 120 is mounted, the male luer connector 103a of the container 103 is inserted into the sleeve 126d and exerts a pressure F1 on the valve 127 which moves the section 1271 away from the shoulder 126F, the effect of which is to allow the liquid to flow through a central recess 127j of the spike 127F, then around the sections 1271, 127n and 127m, then around the spike 127g and through a recess 127k of this spike in the direction of the chamber 123 and then into the passage 122a of the needle 122.

The situation in this case is illustrated in fig. 7, since the creep flap valve 127 of material is compressed at the height of the section 127n under the influence of the force F1, the local deformation of the flap valve does not impede the flow of liquid, since the diameter d2 of the stationary section 127n is at all smaller than the inner diameter d4 of the sleeve 126d at the height of the flap valve 127.

When the male luer connector 103a is withdrawn from the sleeve 126d, the valve returns to the state shown in fig. 6 and 8, and the valve V formed by the components 126d and 127 is closed again.

The pointed shoulder 126f, which is a tapered annular rim, ensures good tightness between the sleeve 126d and the flap valve 127, including after a number of operations of the valve V.

As previously described, the sleeve 126d is provided with a flange 126g allowing a nut 103b to be screwed on to ensure the progressiveness and continuity of the force F1.

The flap valve 127 is symmetrical about its median transverse plane P, which makes it possible to fit it in the sleeve 126d without particular care, each section 1271 or 127m being able to cooperate with a shoulder or rim 126 f.

The present invention shows a container shaped as a syringe 3. However, it is applicable to other containers, such as a flexible bag, so long as the containers are adapted to exert a force on the flap valve 27 similar to the force F1.

Claims (14)

1. Apparatus for effecting a connection between a sealed receptacle and a container, said sealed receptacle comprising a neck portion, the opening of which is blocked by a stopper, said connection comprising:

a base adapted to be mounted on said receptacle and comprising a sleeve defining a bore;

a piston adapted to slide in said bore between a first position disconnected from said stopper and a so-called delivery position in which a hollow needle carried by or forming said piston extends through said stopper, characterised in that said piston (20; 120) is provided with a valve (V) for controlling the flow of liquid from or into said receptacle (2), said valve being integrated as part (26; 126) of said piston for providing a connection between said container (3) and said needle (22; 122).

2. Device according to claim 1, characterized in that said valve (V) comprises a valve body (26 d; 126d) integral with said piston (20, 21, 26; 120, 121, 126) and a flap valve (27; 127) controlled by said valve body.

3. Device according to claim 2, characterized in that said valve body (26 d; 126d) constitutes an internal shoulder (26 f; 126f) adapted to snugly receive a bearing surface (27h) or portion (1271) of said flap valve (27).

4. The device of claim 3, wherein said shoulder (126a) is adapted to superficially pierce said carrier portion (1271).

5. Device according to any one of the preceding claims, characterized in that said valve (V) comprises a flap valve (27; 127) elastically deformable in said hole (A) along at least one direction (X-X') parallel to the displacement of said piston (20; 120).

6. Device according to any one of the preceding claims, characterized in that said valve (V) comprises a flap valve (27) provided with longitudinal grooves (27e) cooperating with the inner surface of said valve body (26d), these longitudinal grooves (27e) being flow channels for the inflow or outflow of the liquid inside the receptacle (2).

7. Device according to claim 6, characterized in that said flap (27) comprises a circumferential groove (27d) dividing the flap into two pieces (27a, 27b) in which said longitudinal groove (27c) is made.

8. Device according to any one of claims 1-5, characterized in that said valve comprises a flap valve comprising two end sections (1271, 127m) having a diameter (d1) greater than the nominal diameter (d2) of an intermediate section (127n) located between said end sections.

9. Device according to claim 7 or 8, characterized in that said recess (27d) or said intermediate section (127n) is adapted to deform under the effect of the pressure (F1) to which said flap valve (27; 127) is subjected.

10. Device according to any one of claims 5-9, characterized in that the flap valve (27; 127) is symmetrical about its median transverse plane (P).

11. Device according to any one of the preceding claims, characterized in that said valve (V) comprises a valve body (26 d; 126d) provided with means (26 g; 126g) for connecting said container (3; 103), said valve body being suitable for receiving a portion (3 a; 103a) of said container and interacting (Fa) with a flap valve (27; 127) of said valve.

12. Device according to claim 11, characterized in that said valve body (26 d; 126d) is suitable for housing a male luer connector (3 a; 103a) belonging to said container (3; 103) and enabling said flap valve (27; 127) to be operated by directly applying a force (F1) to said piston (20; 120).

13. Device according to any one of the preceding claims, characterized in that it comprises a cap (30) for protecting and isolating said piston (20; 120) with respect to the ambient air, said cap being suitable (h) for being mounted on said base (10) for protecting and isolating said valve (V) independently of the position of said piston.

14. Ready-to-use assembly comprising a closed receptacle (2) containing a product, in particular a pharmaceutical preparation, said receptacle being provided with a neck (4) whose opening is blocked by a stopper (5), and a connecting device (1, 101) according to any one of the preceding claims, mounted on said receptacle (2).