WO2014188126A1

WO2014188126A1 - Base for a connector for an infusion bag

Info

Publication number: WO2014188126A1
Application number: PCT/FR2014/051192
Authority: WO
Inventors: Stéphane Chollet; Cédric GAUSIN; Claude Benoit-Gonin; Philippe Bardet
Original assignee: Maco Pharma; Obrist Closures Switzerland Gmbh
Priority date: 2013-05-22
Filing date: 2014-05-21
Publication date: 2014-11-27
Also published as: FR3005854A1; FR3005854B1; EP2999449A1

Abstract

The invention concerns a connector (3) for an infusion bag (1) comprising at least first and second tubular bodies (4, 5) each forming an access opening and a base (6) extending around said first and second tubular bodies (4, 5), said base (6) being formed from a plate (7) comprising a welding area (8) intended to be welded to the walls of an infusion bag, the plate (7) further comprising a gripping area (9) that extends outside said welding area (8) between the first and second tubular bodies (4, 5), said gripping area (9) having a sufficient size and rigidity to allow gripping.

Description

Connector socket for infusion bag

The invention relates to a connector for an infusion bag and an infusion bag provided with such a connector.

It typically applies to containers for the intravenous administration of medical fluids to a patient. In particular, the invention applies to the infusion bag connectors. The flexible bags are generally made by welding a film or a flexible sheath. To allow access to the inside of the pocket, they are provided with one or more connectors, generally in the form of tubes. One of the connectors forms the injection site allowing the introduction into the bag of an additive such as a drug, and the other forms the infusion site for removing the solute from the bag by connecting a perforator.

In the simplest embodiment, these tubes are welded directly between the walls of the infusion bag as in DE102 23 560 A1. To facilitate the handling and welding of the connectors, it has been envisaged to manufacture connectors in the form of injected parts comprising two tubular ports and a tapered elliptical base including said tubular accesses. The tapered shape of the base makes it easy to weld the connectors to the walls forming the pocket. Such connectors are for example described in DE 295 156 82 U1 or EP 2 386 285. However, the relatively large thickness of the bottom of the base of this type of two-port connector prevents the good collabage of the pocket of perfusion during its emptying and thus its complete emptying. In WO 2006/071781, two connectors of circular section are interconnected either by a body portion intended to be welded to the pocket or by a gripping element forming a space between the two connectors for a user to be able to slide your fingers. The document FR 2,689,863 describes a flexible pouch provided with a nozzle comprising tubular accesses interconnected by a lamella of sufficiently small thickness to be able to be melted during welding with the sheets of the pouch. A rigid strip may be located outside the pocket between the tubular ports, directly in the extension of the strip or at a distance therefrom.

The invention proposes a connector for infusion bag for obtaining a good emptying of the infusion bag while reducing the risk of deformation in particular sterilization steps and storage.

For this purpose, the invention proposes a connector for an infusion bag comprising at least a first and second tubular body each forming an access orifice and a base extending around said first and second tubular bodies, said base being formed of a wafer comprising a welding zone for being welded to the walls of an infusion bag, the wafer further comprising a gripping zone which extends outside said welding zone between the first and second tubular bodies, said gripping zone having a size and rigidity sufficient to allow gripping.

Other objects and advantages will become apparent from the following description. FIG. 1 represents a schematic view of an infusion bag equipped with a connector according to the invention.

FIG. 2 represents a schematic and perspective view of the connector of FIG. 1.

FIG. 3 represents a schematic and cross-sectional view of the connector of FIG. 2. FIG. 4 represents a schematic bottom view of the connector of FIG. 2.

FIG. 5 represents a diagrammatic view in section along the axis A-A identified in FIG.

Figure 6 shows a schematic perspective and exploded view of the connector of Figure 2 and the various parts equipping it. FIG. 7 represents a schematic and sectional view of the first tubular body of the connector of FIG. 2.

FIG. 8 represents a diagrammatic sectional view of the socket and the shutter of the connector of FIG. 2.

FIG. 9 represents a schematic and partially sectional view of the connector cap of FIG. 2.

Figure 10 shows a schematic cross-sectional view of the cap of the connector of Figure 2 locked in rotation on the tubular body.

Figure 1 1 is a schematic sectional view of another embodiment of said first tubular body, pierced by a perforator. In the following description, the terms "upstream" and "downstream" are defined relative to the flow direction of the fluid from the inside of the pocket to the outside.

The invention relates to a connector for an infusion bag and an infusion bag comprising such a connector.

Such a pocket is shown in FIG. In FIG. 1, the pocket 1 is formed of two flexible sheets associated with each other along a joint 2. Alternatively, the pocket is formed of a flexible sheet folded on itself or a flexible sheath.

The bag is made in particular of a flexible and sterilizable thermoplastic material such as polyvinyl chloride, a polyolefin, ethylene vinyl acetate.

To allow access to the inner volume of the bag, it is provided with a connector 3 disposed between the walls of the bag and comprising at least a first and second tubular body 4,5 each forming an access port to the inside volume of the pocket.

For example, the first tubular body 4 forms an infusion site adapted to receive the perforator of an infusion line for administering fluid contained in the bag to a patient. The second tubular body 5 forms an injection site adapted to allow the introduction of an additive, such as a drug solution, into the internal volume of the bag, via a syringe or a device transfer. In connection with FIG. 2, the connector of the invention comprises at least a first and a second tubular body 4, each forming an access orifice, and a base 6 extending around said first and second tubular bodies , said base 6 being formed of a plate 7. The base 6 serves to support the tubular bodies 4,5 so as to form a unitary piece easily manipulated.

The base 6 is formed of a plate 7, solid, thin and having a substantially flat surface. In particular, the plate 7 is arranged in a plane of symmetry of the tubular bodies 4,5. The thickness of the wafer 7 between the two tubular bodies 4,5 is in particular smaller than the external diameter of the tubular bodies 4,5, generally of the order of one millimeter, in particular less than one millimeter. The thickness of the wafer 7 is for example of the order of 0.8 mm.

In an alternative embodiment not shown, the thickness of the wafer increases in the direction of the tubular bodies to a thickness substantially equal to that of the outer diameter of the tubular bodies, thus having, in cross-section with respect to the axis tubular bodies, the general shape of a tapered ellipse around said tubular bodies. This base 6 formed of a plate 7 allows the good bonding of the walls of the pocket 1, that is to say the crushing of the walls of the pocket against each other, at the connector 3, when emptying the pocket. A good collabage thus optimizes the complete emptying of the bag during an infusion to a patient. Thicker or hollow bases prevent the walls from collapsing at the connector, thus creating a retention zone of the fluid contained in the pocket.

According to the invention and in connection with FIG. 3, the wafer 7 comprises a welding zone 8 intended to be welded to the walls of an infusion bag and a gripping zone 9 which extends outside said zone welding between the first and second tubular body 4,5, said gripping area 9 having a size and rigidity sufficient to allow gripping. The welding zone 8 is formed of a part of each of the faces of the wafer 7. The welding zone 8 corresponds to the area of the wafer 7 which will be placed between the walls of the infusion bag. As illustrated in FIG. 2, this welding zone is provided with welding ribs 10 in order to facilitate the welding of the walls of the pocket on the connector 3. The welding ribs 10 are arranged over the entire length of the wafer, perpendicular to the axis of the tubular bodies 4,5.

The thickness of the welding ribs 10 is of the order of 0.5 mm. The number of welding ribs depends on the size of the weld zone 8 and the size 10. In FIG. 2, four welding ribs 10 are shown.

Advantageously and as shown in FIG. 2, when the wafer 7 has a thickness that is substantially constant over its entire length, the thickness of the welding ribs 10 increases towards the tubular bodies 4,5, thus having a cross-sectional relation to the to the axis of the tubular bodies 4,5, the general shape of an ellipse tapered around said bodies (Figure 4).

As shown in Figures 2 and 3, each transverse end of the wafer 7 forming the base 6 is extended by a tongue January 1. These tongues January 1 have a reduced thickness relative to that of the wafer 7, for example of the order of 0.25 mm. These tongues 1 1 improve the welding of the walls of the infusion bag on the connector 3.

The gripping zone 9 of the wafer 7 extends the welding zone 8. This gripping zone 9 is in particular full, that is to say that it does not have an aperture. This gripping zone 9 allows a user to enter the pocket 1 between his fingers. During the manufacture of the pocket, this gripping zone 9 can also be grasped by a machine to automate the manufacture. In addition, this gripping zone 9 limits the fragility of the connector generated by the fineness of the base.

Advantageously and as shown in Figures 2 and 3, the gripping zone 9 is provided with gripping ribs 12. These gripping ribs 12 extend perpendicularly to the axis of the tubular bodies 4,5.

These gripping ribs 12, for example four in number, have a thickness less than that of the welding ribs 10. For example, the gripping ribs 12 have a thickness of the order of 0.25 mm. In a particular embodiment, a reinforcing element 13 is arranged in the gripping zone 9 away from the welding zone 8 of the wafer 7. This reinforcing element is positioned between the two tubular bodies 4, perpendicular to the axis of each of the tubular bodies 4,5. This positioning thus limits the deformation of the connector 3 in the plane defined by the axes of the tubular bodies. This reinforcing element 13, in cooperation with the gripping zone 9, prevents the deformation of the connector 3 and in particular the tubular bodies 4,5 during the transport, storage, welding and sterilization steps. Indeed, the base 6 being formed of a plate 7, and therefore being substantially thin, it is fragile and can break or easily deform. The presence of this reinforcing element 13 increases the strength of the connector 3.

In addition, during manufacture and in particular the welding of the pockets, this reinforcing element 13 allows a machine to correctly and reproducibly position the connector 3 for its welding to the walls of the infusion bag.

According to Figure 2, the reinforcing element 13 is in the form of a reinforcing rib. For example, the reinforcing rib has a thickness of the order of 1.8 mm.

As shown in FIGS. 4 and 5, each of the faces of the wafer 7 forming the base 6 comprises welding ribs 10, gripping ribs 12 and a reinforcing rib 13.

As shown in section in Figure 3, the connector comprises a first tubular body 4 and a second tubular body 5, each forming an access port to the interior volume of the pocket.

The first tubular body 4, in particular forming an infusion site, is equipped with a sleeve 14 having a perforable transverse partition 15 intended to seal the access orifice, with a perforable shutter 16 arranged in a sealed manner on said transverse partition 1 5, and a cap 1 7 intended to compress on the tubular body 4 said perforable shutter 1 6 mounted on said sleeve 14. In Figures 3 and 8, the sleeve comprises a flange 1 8 in particular on the edge of the first tubular body 4. In particular, the sleeve 14 is formed of a substantially cylindrical element having at its downstream end the ledge 8 directed towards the outside of the sleeve 14. The transverse partition 1 5 of the bushing 14 is located in particular in the downstream portion of said bushing 14, in particular at the downstream end. For example, the curved transverse partition extends outwardly of the bushing to form said flange 1 8. This bushing 14 is force-fitted inside the first tubular body 4, the flange 1 8 of the bushing resting on the downstream end of said first tubular body 4. Thus, the transverse partition 15 of the sleeve 14 hermetically closes the first tubular body 4 so as to prevent, before perforation, the passage of the fluid contained in the pocket towards the outside of said poached.

In order to increase the seal between the bushing 14 and said first tubular body 4, the upstream portion of the bushing 14, before assembly in the first tubular body 4, is flared, that is to say that the upstream outside diameter of the socket

14 is slightly greater than its downstream outside diameter.

The transverse partition 1 5 is perforable, in particular by a perforator 36 as shown in Figure 1 1, or by a cannula. The transverse partition

15 is in the form of a thin wall, of the order of 0.25 mm, made of the same material as the cylindrical element of the sleeve 14.

The perforable shutter 16 is sealingly disposed on the transverse wall 15 of the socket, that is to say on the downstream side of the partition. So, the transverse partition 15, before perforation, also prevents the direct contact of the fluid contained in the infusion bag with the perforable shutter 16.

The perforable shutter 16 comprises an elastomeric membrane, rubber or other similar material, which can be traversed by a perforator and close on its own once the perforator has been removed. The perforator is for example that of a perfusor.

In a particular embodiment, the sleeve 14 and the perforable shutter 16 form a unitary piece. In particular, the bushing 14 and the perforable shutter 16 are welded together in an inseparable manner. For example, the bushing 14 and the perforable shutter 16 are formed by bi-injection molding.

The first tubular body 4 is also equipped with a cap 17 for compressing said perforable shutter 16 and said sleeve 14 on the tubular body 4. As shown in FIG. 3, the cap 17 covers said first tubular body 4.

For this, the first tubular body 4 and the cap 17 have complementary latching projections 19,20, shown in particular in FIG. 3.

In one embodiment, the cap 17 is formed of a transverse wall 21 extending into a peripheral skirt 22, visible in FIG. 9. When the cap 17 is placed on the first tubular body 4, as in FIG. transverse 21 crushes the pierceable shutter 16 to keep it firmly clamped in said first tubular body 4.

In addition, the cap 17 has an opening 23 arranged to allow the introduction of a perforator into the shutter. The opening 23 is arranged in the transverse wall 21 of the cap 17 as shown in FIGS. 9 and 11. In order to guarantee the tightness of the connector 3 and thus the absence of contamination of the fluid contained in the infusion bag, the surface of the transverse partition 15 of the sleeve 14 in contact with the perforable shutter 16 is curved so as to increase locally compressing said perforable shutter 16 between said cap 17 and said tubular body 4, especially during perforation.

In particular, the curved shape increases the compression of the part of the perforable shutter 16 which is arranged between the transverse wall 21 of the cap 17 and the flange 18 of the sleeve 14.

In axial section, as in fig 3, the shape of the transverse partition 15 is not straight, but curved, that is to say that the central zone of the transverse partition 15 is not at the same level as the peripheral zone of said transverse partition 15.

This curved shape of the transverse partition 15 in close contact with the perforable shutter 16 will increase the vertical stress exerted by the cap 17 on the perforable shutter 16 during placement of the cap 17 on the first tubular body 4.

In particular, the surface of said transverse partition 15 is curved towards the inside of the bushing 14, that is to say upstream. In other words, the transverse partition 15 is convex upstream of the connector.

Alternatively shown in Figure 1 1, the surface of said transverse partition 15 is curved outwardly of the sleeve 14, that is to say downstream. In other words, the transverse partition 15 is concave upstream of the connector. As the perforable shutter 16 is sealingly disposed on the transverse partition 15 of the sleeve 14, the surface of the perforable shutter 16 in contact with the transverse partition 15 has a curved complementary shape. The surface of the perforable shutter 16 in contact with the cap 17 and in particular the transverse wall 21 of the cap 17 is flat. The perforable shutter 16 is thus substantially plano-convex or plane-concave.

The seal between the cap 17 and the perforable shutter 16 is further increased when the sleeve 14 has a flared shape as defined above.

According to an embodiment shown in Figures 3 and 9, the connector 3 further comprises a plug 24 having a weak zone 25 associated with the cap 17, said zone of weakness 25 being arranged to be broken by a manual action so as to separate the plug 24 from said cap 17 and allow access to the opening of the cap 17. The plug 24 protects the perforable shutter 16 until the user wants to perforate said shutter by a perforator. In particular, the zone of weakness 25 of the stopper 24 can be broken during a lateral or rotational load. The first tubular body 4 is advantageously rigid in order to avoid being deformed or twisted when opening the stopper 24.

Advantageously, the plug 24 comprises a pallet 26 of shape and size sufficient for a user to grasp it between his fingers. The zone of weakness 25 is broken by exerting a rotational movement or a lateral movement on this pallet 26, making accessible the opening 23 of the cap 17 and therefore the pierceable shutter 16.

The zone of weakness 25 is, for example, a zone of small thickness, for example of the order of 0.1 mm.

In relation with FIG. 3, in order to prevent tilting of the cap 17, in particular during the rupture of the zone of weakness 25 of the cap 24, the first tubular body 4 has on its outer surface a flange 27 in front of which the cap 17 is disposed.

Alternatively or in addition, the cap 17 is locked in rotation on the tubular body 4.

For this purpose, and according to FIGS. 6 and 7, the tubular body 4 has axial fins 28 distributed on its external surface which engage in corresponding ridges 29 arranged on the inner surface of the cap 17, so as to lock in rotating the cap 17 on the tubular body 4.

The fins 28 are in particular arranged between the flange 27 and the snap-fitting projection 19 of the first tubular body 4. In particular, but not necessarily, the fins 28 are in contact with said flange 27. For example, the number of fins 28 is between 1 and 10, especially 8.

These fins 28 engage in ridges 29 provided on the inner surface of the cap 17. The number of ridges 29 is equal to or greater than the number of fins 28. A greater number of ridges 29 facilitate the mounting of the cap 17 on the tubular body 4.

In relation with FIG. 3, the second tubular body 5, forming in particular an injection site, is equipped with a tip 30 and a perforable shutter 31 sealingly disposed in said tip 30.

The second tubular body 5 is advantageously flexible to allow manual or automatic clamping to control the introduction of an additive into the pocket.

Alternatively, the second tubular body is equipped with a shutter type "nail cap" (not shown). The tip 30 has an upstream cylindrical portion 32 and a downstream cylindrical portion 33, the upstream portion 32 being intended to be introduced in a sealed manner into the second tubular body 5 and the downstream portion 33, of outside diameter slightly greater than the outside diameter of the upstream portion 32 remains outside said second tubular body 5 while resting on the edge of said second tubular body 5.

The inside diameter of the upstream portion 32 is advantageously smaller than the inside diameter of the downstream portion 33 so as to create a bearing surface 34 on which the perforable shutter 31 rests.

The perforable shutter 31 of the second tubular body 5 comprises an elastomeric membrane, rubber or other similar material, which can be traversed by a needle and close on its own once the needle has been removed. The needle is for example that of a syringe containing a drug solution to be added to the fluid contained in the infusion bag or that of a transfer device for transferring the drug content of a vial into said infusion bag. According to one embodiment, the second tubular body 5 is provided with a transverse and perforable wall 35, intended to ensure the tight closure of the second tubular body 5, sealingly closing said tubular body 5 to the perforation of said partition 35. Advantageously, the partition 35 of the second tubular body 5 is located near the upstream end of said tip 30.

The assembly of such a connector 3 is particularly easy and requires only a few steps.

According to a particular mode of manufacture and assembly, the various parts constituting the connector are molded and mechanically assembled. In particular, it is produced by injection molding on the one hand a connector 3 comprising a first and second tubular body 4,5 and a base 6 extending around said first and second bodies 4,5 as described above and shown in Figure 6 and on the other hand, the cap 17 provided a plug 24. The sleeve 14 and the perforable shutter 16 are made in one piece by bi-injection molding.

To assemble the perfusion site, simply insert the sleeve 14 and the perforable shutter 16 in the first tubular body 4, then snap the cap 17. Similarly, the injection site is assembled by inserting the endpiece 30 provided with a perforable shutter 31 in the second tubular body 5.

Once the connector is assembled, it is sterilized, especially by heat. By choosing the appropriate materials, the various parts of the connector 3 are thermally welded during this sterilization step, thus providing a fully sealed connector and easy to weld.

Claims

1. Connector (3) for infusion bag (1) comprising at least first and second tubular bodies (4,5) each forming an access port and a base (6) extending around said first and second tubular bodies (4). , 5), said base (6) being formed of a wafer (7) comprising a welding zone (8) intended to be welded to the walls of an infusion bag, characterized in that the wafer (7) comprises in in addition to a gripping zone (9) which extends outside said welding zone (8) between the first and second tubular bodies (4,5), said gripping zone (9) having a size and rigidity sufficient to allow grasping.

2. Connector according to claim 1, characterized in that a reinforcing element (13) is arranged in said gripping zone (9) away from said welding zone (8).

3. Connector according to claim 2, characterized in that the reinforcing element (13) is in the form of a reinforcing rib.

4. Connector according to any one of claims 1 to 3, characterized in that the welding zone (8) is provided with welding ribs (10).

5. Connector according to any one of claims 1 to 4, characterized in that the gripping area (9) is provided with gripping ribs (12).

6. Connector according to any one of claims 1 to 5, characterized in that each transverse end of the wafer (7) is extended by a tongue (1 1).

7. Connector according to any one of claims 1 to 6, characterized in that said first tubular body (4) is equipped with a sleeve (14) having a perforable transverse wall (15) for sealing the l access port, a perforable shutter (16) sealingly disposed on said transverse partition (15), and a cap (17) for compressing on the tubular body (4) said perforable shutter (16) mounted on said sleeve (14), the surface of said transverse partition (15) in contact with the perforable shutter (16) being curved so as to locally increase the compression of said perforable shutter (16) between said cap (17) and said tubular body (4).

8. Infusion bag comprising a connector according to any one of claims 1 to 7.