WO2014188128A1 - Stopper of a connector for an infusion bag - Google Patents

Stopper of a connector for an infusion bag Download PDF

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Publication number
WO2014188128A1
WO2014188128A1 PCT/FR2014/051194 FR2014051194W WO2014188128A1 WO 2014188128 A1 WO2014188128 A1 WO 2014188128A1 FR 2014051194 W FR2014051194 W FR 2014051194W WO 2014188128 A1 WO2014188128 A1 WO 2014188128A1
Authority
WO
WIPO (PCT)
Prior art keywords
tubular body
cap
connector
connector according
perforable
Prior art date
Application number
PCT/FR2014/051194
Other languages
French (fr)
Inventor
Claude Benoit-Gonin
Philippe Bardet
Stéphane Chollet
Original Assignee
Maco Pharma
Obrist Closures Switzerland Gmbh
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Maco Pharma, Obrist Closures Switzerland Gmbh filed Critical Maco Pharma
Priority to EP14731699.6A priority Critical patent/EP2999450B1/en
Publication of WO2014188128A1 publication Critical patent/WO2014188128A1/en

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/1406—Septums, pierceable membranes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/1475—Inlet or outlet ports
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/05—Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • A61J1/10—Bag-type containers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/1475—Inlet or outlet ports
    • A61J1/1481—Inlet or outlet ports with connection retaining means, e.g. thread or snap-fit
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2006—Piercing means
    • A61J1/201—Piercing means having one piercing end

Definitions

  • the invention relates to a connector for an infusion bag and an infusion bag provided with such a connector.
  • the invention typically applies to containers for the intravenous administration of medical fluids to a patient.
  • 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.
  • the perfusion site is adapted to receive the perforator of an infusion line and advantageously comprises a first perforable membrane and, at a distance from this first membrane, a second perforable membrane - said auto -rescient - which closes after removal of the perforator.
  • This infusion site is also provided with a cap protecting the access to the self-resealing membrane until it is used.
  • the injection site for the introduction of an additive into the bag is also provided with a self-resealing membrane which can be pierced by the needle of a syringe or a transfer device.
  • EP 0 01 1 144 discloses a connector for infusion bag comprising a tube, a bowl placed in the tube, whose bottom forms a flat diaphragm and in which is arranged a membrane, and a breakable stopper.
  • WO 2006/071781 discloses a connector system for an infusion bag, consisting of two types of ports: an addition port for connecting a needle and an administration port for connecting a perforator.
  • the port of addition is formed of an assembly which comprises: (a) a closure body comprising an open cylinder in which is placed a flat diaphragm open to the flow of fluid once pierced by a needle, (b) a plug assembly comprising a shell surmounted by a removable plug, and (c) a self-resealing membrane placed between the closure body and the plug assembly which is mechanically held in the assembly.
  • the administration port is formed of an assembly which comprises: (a) a second closure body comprising a sleeve whose upper portion is tapered so as to be able to connect different sizes of connectors, and (b) a second similar cap assembly to the plug assembly of the port of addition.
  • US-4,632,673 discloses an injection or infusion site either directly welded to a wall of the pouch, or placed on the inlet or outlet tube of the pouch.
  • the injection site is formed of a connector in the form of a tube on which or in which is disposed a pierceable rubber pellet.
  • a flexible protective film is arranged under the pellet.
  • Another flexible film forming a cap and provided with a tearable tab covers the pellet.
  • the various elements of this connector are assembled by adhesion. These flexible films conform to the shape of the pellet but do not compress it, so that if adhesion is defective, tightness and sterility are no longer assured.
  • the connector of the invention has a particular structure enabling it to ensure a good seal, especially during sterilization by steam.
  • the invention proposes a connector for an infusion bag comprising at least a first tubular body forming an access orifice, said tubular body being equipped with a sleeve having a perforable transverse partition intended to ensure the tight closure of the access port, a perforable shutter sealingly disposed on said transverse partition, and a cap for compressing on the tubular body said perforable shutter mounted on said sleeve, the surface of said transverse partition in contact with the perforable shutter being curved so as to locally increase the compression of said perforable shutter between said cap and said tubular body.
  • 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 diagrammatic 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 AA 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 a connector, pierced by a perforator.
  • FIG. 12 represents a diagrammatic sectional view of the socket and the shutter of the connector of FIG.
  • 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.
  • the bag 1 is formed of two flexible sheets associated with each other along a peripheral seal 2.
  • the bag 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.
  • 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.
  • 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.
  • 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.
  • 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 outer 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.
  • 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.
  • 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 welding zone between the first and second and second tubular body 4,5, said gripping area 9 having sufficient size and stiffness to allow gripping.
  • 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 welding zone 8 and the size of said ribs 10.
  • FIG. 2 four welding ribs 10 are shown.
  • 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).
  • 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.
  • 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.
  • gripping ribs 12 for example four in number, have a thickness less than that of the welding ribs 10.
  • the gripping ribs 12 have a thickness of the order of 0.25 mm.
  • 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.
  • the base 6 being formed of a plate 7, and therefore being substantially thin, it is fragile and can break or easily deform.
  • This reinforcing element 13 increases the strength of the connector 3.
  • this reinforcing element 13 allows a machine to correctly and reproducibly position the connector 3 in position. view of its welding to the walls of the infusion bag.
  • the reinforcing element 13 is in the form of a reinforcing rib.
  • the reinforcing rib has a thickness of the order of 1.8 mm.
  • each of the faces of the wafer 7 forming the base 6 comprises welding ribs 10, gripping ribs 12 and a reinforcing rib 13.
  • 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, a perforable shutter 16 arranged in a sealed manner 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 bushing comprises a flange 18 compressed on the edge of the first tubular body 4.
  • the bushing 14 is formed of a substantially cylindrical element having at its downstream end the flange 18 directed towards the outside of the socket 14.
  • the transverse wall 15 of the bushing 14 is located in particular in the downstream portion of said bushing 14, in particular at the downstream end.
  • the curved transverse partition extends outwardly of the bushing to form said flange 18.
  • This bushing 14 is mounted in force inside the first tubular body 4, the flange 18 of the bushing resting on the downstream end of said first tubular body 4.
  • the transverse partition 15 of the bushing 14 hermetically closes the first body tubular 4 so as to prevent, before perforation, the passage of the fluid contained in the pocket to the outside of said pocket.
  • 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 bushing 14 is slightly greater than its downstream outside diameter.
  • the transverse partition 15 is perforable, in particular by a perforator 36 as shown in FIG. 11, 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.
  • 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 a membrane of elastomer, rubber or other similar material, which can be traversed by a perforator and close by itself once the perforator has been removed.
  • the perforator is for example that of a perfusor.
  • the perforable shutter 16 has a substantially cylindrical body of relatively small height relative to the diameter.
  • the body has a shoulder bearing on the flange 18 of the sleeve 14 when the perforable shutter 16 is mounted in said sleeve.
  • the transverse wall 21 of the cap 17 compresses the pierceable shutter
  • the central portion of the downstream surface of said body has a disk-shaped scar slightly curved towards the inside of the sleeve 14. And, according to the invention, the upstream surface of said body is substantially curved.
  • the sleeve 14 and the perforable shutter 16 form a unitary piece.
  • the bushing 14 and the perforable shutter 16 are welded together in an inseparable manner.
  • 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.
  • first tubular body 4 and the cap 17 have complementary latching projections 19,20, shown in particular in FIG. 3.
  • the cap 17 is formed of a transverse wall 21 extending into a peripheral skirt 22, visible in FIG.
  • the transverse wall 21 crushes the perforable shutter 16 in order to keep it firmly clamped in said first tubular body 4.
  • 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.
  • the surface of the transverse partition 15 of the sleeve 14 in contact with the perforable shutter 16 is curve so as to locally increase the compression of said perforable shutter 16 between said cap 17 and said tubular body 4, especially during the perforation.
  • 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.
  • 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.
  • the surface of said transverse partition 15 is curved towards the inside of the bushing 14, that is to say upstream.
  • the transverse septum 15 is convex when the infusion bag is used, i.e., when the bag is disposed so that the fluid in the bag flows from the inside of the outside.
  • the surface of said transverse partition 15 is curved outwardly of the sleeve 14, that is to say downstream.
  • the transverse septum is concave when the infusion bag is used, i.e., when the bag is disposed for the fluid in the bag to flow from the inside of the outside.
  • 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.
  • 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 wishes to perforate said shutter by a perforator.
  • 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.
  • 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.
  • the first tubular body 4 has on its outer surface a collar 27 with respect to which the cap 17 is arranged.
  • the cap 17 is locked in rotation on the tubular body 4.
  • 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 rotation 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 body
  • the fins 28 are in contact with said flange 27.
  • the number of fins 28 is between 1 and 10, in particular 8. These fins 28 engage in streaks 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • the various parts constituting the connector are molded and mechanically assembled.
  • injection molding is carried out on the one hand by 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 represented on Figure 6 and secondly, the cap 17 provided with a plug 24.
  • the sleeve 14 and the perforable shutter 16 are made in one piece by bi-injection molding.
  • the injection site is assembled by inserting the tip 30 provided with a perforable shutter 31 in the second tubular body 5.
  • the connector is sterilized, especially by heat.
  • the various parts of the connector 3 are thermally welded during this sterilization step, thus providing a fully sealed connector and easy to weld.

Abstract

The invention relates to a connector (3) for an infusion bag comprising at least a first tubular body (4) forming an access opening, said tubular body (4) being provided with a bushing (14) having a perforable transverse wall (15) for ensuring the tight closure of the access opening, a perforable stopper (16) arranged hermetically on said transverse wall (15), and a cap (17) for compressing said perforable stopper (16) mounted on said bushing (14) onto the tubular body (4), the surface of said transverse wall (15) which is in contact with the stopper (16) being curved so as to locally increase the compression of said perforable stopper (16) between said cap (17) and said tubular body (4).

Description

Obturateur d'un connecteur pour poche de perfusion  Shutter of a connector for an infusion bag
L'invention concerne un connecteur pour poche de perfusion ainsi qu'une poche de perfusion munie d'un tel connecteur. The invention relates to a connector for an infusion bag and an infusion bag provided with such a connector.
Elle s'applique typiquement aux récipients pour l'administration par voie intraveineuse de fluides médicaux à un patient. Notamment, l'invention s'applique aux connecteurs de poches de perfusion. 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.
Les poches souples sont généralement réalisées par soudage d'un film ou d'une gaine souple. Pour permettre l'accès à l'intérieur de la poche, celles-ci sont munies d'un ou plusieurs connecteurs, généralement sous forme de tubes. L'un des connecteurs forme le site d'injection permettant l'introduction dans la poche d'un additif tel qu'un médicament, et l'autre forme le site de perfusion permettant le retrait du soluté de la poche en connectant un perforateur. 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.
De nombreux documents ont déjà décrits différentes réalisations de connecteurs. Par exemple, dans le document DE102 23 560 A1 , le site de perfusion est adapté pour recevoir le perforateur d'une ligne de perfusion et comporte avantageusement une première membrane perforable et, à distance de cette première membrane, une deuxième membrane perforable - dite auto-rescellante - qui se referme après retrait du perforateur. Ce site de perfusion est également pourvu d'un capuchon protégeant l'accès à la membrane auto-rescellante jusqu'à son utilisation. Many documents have already described different embodiments of connectors. For example, in DE102 23 560 A1, the perfusion site is adapted to receive the perforator of an infusion line and advantageously comprises a first perforable membrane and, at a distance from this first membrane, a second perforable membrane - said auto -rescient - which closes after removal of the perforator. This infusion site is also provided with a cap protecting the access to the self-resealing membrane until it is used.
Dans ce document, le site d'injection pour l'introduction d'un additif dans la poche est muni lui aussi d'une membrane auto-rescellante pouvant être percée par l'aiguille d'une seringue ou d'un dispositif de transfert. In this document, the injection site for the introduction of an additive into the bag is also provided with a self-resealing membrane which can be pierced by the needle of a syringe or a transfer device.
Le document EP 0 01 1 144 décrit un connecteur pour poche de perfusion comprenant un tube, une cuvette placée dans le tube, dont le fond forme un diaphragme plat et dans laquelle est arrangée une membrane, et un bouchon cassable. EP 0 01 1 144 discloses a connector for infusion bag comprising a tube, a bowl placed in the tube, whose bottom forms a flat diaphragm and in which is arranged a membrane, and a breakable stopper.
Le document WO 2006/071781 décrit un système de connecteur pour poche de perfusion, composé de deux types de ports : un port d'addition pour connecter une aiguille et un port d'administration pour connecter un perforateur. Le port d'addition est formé d'un assemblage qui comprend : (a) un corps de fermeture comprenant un cylindre ouvert dans lequel est placé un diaphragme plat ouvert à l'écoulement de fluide une fois percé par une aiguille, (b) un ensemble bouchon comprenant une coque surmontée d'un bouchon amovible, et (c) une membrane auto-rescellante placée entre le corps de fermeture et l'ensemble bouchon qui est maintenue de façon mécanique dans l'assemblage. Le port d'administration est formé d'un assemblage qui comprend : (a) un second corps de fermeture comprenant un manchon dont la partie supérieure est conique de sorte à pouvoir connecter différentes tailles de connecteurs, et (b) un second ensemble bouchon similaire à l'ensemble bouchon du port d'addition. WO 2006/071781 discloses a connector system for an infusion bag, consisting of two types of ports: an addition port for connecting a needle and an administration port for connecting a perforator. The port of addition is formed of an assembly which comprises: (a) a closure body comprising an open cylinder in which is placed a flat diaphragm open to the flow of fluid once pierced by a needle, (b) a plug assembly comprising a shell surmounted by a removable plug, and (c) a self-resealing membrane placed between the closure body and the plug assembly which is mechanically held in the assembly. The administration port is formed of an assembly which comprises: (a) a second closure body comprising a sleeve whose upper portion is tapered so as to be able to connect different sizes of connectors, and (b) a second similar cap assembly to the plug assembly of the port of addition.
Le document US-4 632 673 décrit une site d'injection ou de perfusion soit directement soudé à une paroi de la poche, soit placé sur le tube d'entrée ou de sortie de la poche. Dans ce dernier cas, le site d'injection est formé d'un connecteur sous forme de tube sur lequel ou dans lequel est disposée une pastille perforable en caoutchouc. Pour éviter le contact direct du fluide contenu dans la poche avec la pastille, un film souple protecteur est arrangé sous la pastille. Un autre film souple formant coiffe et muni d'une languette déchirable recouvre la pastille. Les différents éléments de ce connecteur sont assemblés par adhésion. Ces films souples se conforment à la forme de la pastille mais ne la compressent pas, de sorte que si une adhésion est défectueuse, l'étanchéité et la stérilité ne sont plus assurées. US-4,632,673 discloses an injection or infusion site either directly welded to a wall of the pouch, or placed on the inlet or outlet tube of the pouch. In the latter case, the injection site is formed of a connector in the form of a tube on which or in which is disposed a pierceable rubber pellet. To avoid direct contact of the fluid contained in the bag with the pellet, a flexible protective film is arranged under the pellet. Another flexible film forming a cap and provided with a tearable tab covers the pellet. The various elements of this connector are assembled by adhesion. These flexible films conform to the shape of the pellet but do not compress it, so that if adhesion is defective, tightness and sterility are no longer assured.
Plusieurs propriétés sont attendues de ces connecteurs. D'abords, ils doivent être faciles à monter sur les poches de perfusion. Ensuite, ils doivent être étanches pour éviter de contaminer le contenu de la poche. Notamment, cette étanchéité doit être maintenue lors de l'étape de stérilisation, en particulier lors d'une stérilisation par vapeur qui fait subir de fortes contraintes de déformation aux connecteurs. Enfin, les connecteurs doivent être faciles à manipuler pour le personnel soignant. Le connecteur de l'invention possède une structure particulière lui permettant d'assurer une bonne étanchéité, notamment lors de la stérilisation par vapeur. Several properties are expected from these connectors. In the first place, they must be easy to mount on the infusion bags. Then they must be waterproof to avoid contaminating the contents of the pocket. In particular, this seal must be maintained during the sterilization step, in particular when steam sterilization which makes the connectors suffer from high deformation stresses. Finally, the connectors must be easy to handle for the nursing staff. The connector of the invention has a particular structure enabling it to ensure a good seal, especially during sterilization by steam.
A cet effet, l'invention propose un connecteur pour poche de perfusion comprenant au moins un premier corps tubulaire formant un orifice d'accès, ledit corps tubulaire étant équipé d'une douille présentant une cloison transversale perforable destinée à assurer la fermeture étanche de l'orifice d'accès, d'un obturateur perforable disposé de façon étanche sur ladite cloison transversale, et d'une coiffe destinée à compresser sur le corps tubulaire ledit obturateur perforable monté sur ladite douille, la surface de ladite cloison transversale en contact avec l'obturateur perforable étant courbe de sorte à augmenter localement la compression dudit obturateur perforable entre ladite coiffe et ledit corps tubulaire. For this purpose, the invention proposes a connector for an infusion bag comprising at least a first tubular body forming an access orifice, said tubular body being equipped with a sleeve having a perforable transverse partition intended to ensure the tight closure of the access port, a perforable shutter sealingly disposed on said transverse partition, and a cap for compressing on the tubular body said perforable shutter mounted on said sleeve, the surface of said transverse partition in contact with the perforable shutter being curved so as to locally increase the compression of said perforable shutter between said cap and said tubular body.
D'autres objets et avantages apparaîtront au cours de la description qui suit. Other objects and advantages will become apparent from the following description.
La figure 1 représente une vue schématique d'une poche de perfusion équipée d'un connecteur selon l'invention. FIG. 1 represents a schematic view of an infusion bag equipped with a connector according to the invention.
La figure 2 représente une vue schématique et en perspective du connecteur de la figure 1 . FIG. 2 represents a schematic and perspective view of the connector of FIG. 1.
La figure 3 représente une vue schématique et en coupe transversale du connecteur de la figure 2. La figure 4 représente une vue schématique de dessous du connecteur de la figure 2. FIG. 3 represents a diagrammatic cross-sectional view of the connector of FIG. 2. FIG. 4 represents a schematic bottom view of the connector of FIG. 2.
La figure 5 représente une vue schématique et en coupe selon l'axe A-A identifié sur la figure 3. La figure 6 représente une vue schématique, en perspective et en éclaté du connecteur de la figure 2 et des différentes pièces l'équipant. La figure 7 représente une vue schématique et en coupe du premier corps tubulaire du connecteur de la figure 2. FIG. 5 represents a diagrammatic view in section along the axis AA 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.
La figure 8 représente une vue schématique et en coupe de la douille et de l'obturateur du connecteur de la figure 2. FIG. 8 represents a diagrammatic sectional view of the socket and the shutter of the connector of FIG. 2.
La figure 9 représente une vue schématique et partiellement en coupe de la coiffe du connecteur de la figure 2. FIG. 9 represents a schematic and partially sectional view of the connector cap of FIG. 2.
La figure 10 représente une vue schématique et en coupe transversale de la coiffe du connecteur de la figure 2 bloquée en rotation sur le corps tubulaire. Figure 10 shows a schematic cross-sectional view of the cap of the connector of Figure 2 locked in rotation on the tubular body.
La figure 1 1 représente une vue schématique et en coupe d'une autre réalisation d'un connecteur, transpercé par un perforateur. La figure 12 représente une vue schématique et en coupe de la douille et de l'obturateur du connecteur de la figure 1 1 . Figure 1 1 is a schematic sectional view of another embodiment of a connector, pierced by a perforator. FIG. 12 represents a diagrammatic sectional view of the socket and the shutter of the connector of FIG.
Dans la description qui suit, les termes "amont" et "aval" sont définis par rapport au sens d'écoulement du fluide de l'intérieur de la poche vers l'extérieur. 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.
L'invention concerne un connecteur pour poche de perfusion ainsi qu'une poche de perfusion comprenant un tel connecteur. The invention relates to a connector for an infusion bag and an infusion bag comprising such a connector.
Une telle poche est représentée sur la figure 1 . Sur la figure 1 , la poche 1 est formée de deux feuilles souples associées entre elles le long d'un joint périphérique 2. En variante, la poche est formée d'une feuille souple repliée sur elle-même ou d'une gaine souple. La poche est notamment réalisée dans un matériau thermoplastique souple et stérilisable tel que le polychlorure de vinyle, une polyoléfine, l'éthylène-acétate de vinyle. Pour permettre l'accès au volume intérieur de la poche, celle-ci est pourvue d'un connecteur 3 disposé entre les parois de la poche et comprenant au moins un premier et deuxième corps tubulaire 4,5 formant chacun un orifice d'accès au volume intérieur de la poche. Par exemple, le premier corps tubulaire 4 forme un site de perfusion adapté pour recevoir le perforateur d'une ligne de perfusion en vue d'administrer le fluide contenu dans la poche à un patient. Le deuxième corps tubulaire 5 forme un site d'injection adapté pour permettre l'introduction d'un additif, tel qu'une solution médicamenteuse, dans le volume intérieur de la poche, par l'intermédiaire d'une seringue ou d'un dispositif de transfert. Such a pocket is shown in FIG. In Figure 1, the bag 1 is formed of two flexible sheets associated with each other along a peripheral seal 2. Alternatively, the bag 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.
En relation avec la figure 2, le connecteur de l'invention comprend au moins un premier et deuxième corps tubulaire 4,5 formant chacun un orifice d'accès, et une embase 6 s'étendant autour dudit premier et deuxième corps tubulaire 4,5, ladite embase 6 étant formée d'une plaquette 7. 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.
L'embase 6 sert de support aux corps tubulaires 4,5 de façon à former une pièce unitaire facilement manipulable. L'embase 6 est formée d'une plaquette 7, pleine, peu épaisse et présentant une surface substantiellement plane. Notamment, la plaquette 7 est arrangée dans un plan de symétrie des corps tubulaires 4,5. L'épaisseur de la plaquette 7 entre les deux corps tubulaires 4,5 est en particulier inférieure au diamètre extérieur des corps tubulaires 4,5, généralement de l'ordre du millimètre, notamment inférieure à un millimètre. L'épaisseur de la plaquette 7 est par exemple de l'ordre de 0,8 mm. Dans une variante de réalisation non représentée, l'épaisseur de la plaquette s'accroît en direction des corps tubulaires jusqu'à une épaisseur substantiellement égale à celle du diamètre extérieur des corps tubulaires, présentant ainsi, en coupe transversale par rapport à l'axe des corps tubulaires, la forme générale d'une ellipse effilée autour desdits corps tubulaires. 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 outer 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.
Cette embase 6 formée d'une plaquette 7 permet le bon collabage des parois de la poche 1 , c'est-à-dire l'écrasement des parois de la poche l'une contre l'autre, au niveau du connecteur 3, lors de la vidange de la poche. Un bon collabage optimise ainsi la vidange complète de la poche lors d'une perfusion à un patient. Des embases plus épaisses voire creuses, empêchent les parois de collaber au niveau du connecteur, créant ainsi une zone de rétention du fluide contenu dans la poche. En relation avec la figure 3, la plaquette 7 comprend une zone de soudage 8 destinée à être soudée aux parois d'une poche de perfusion et une zone de préhension 9 qui s'étend à l'extérieur de ladite zone de soudage entre le premier et deuxième corps tubulaire 4,5, ladite zone de préhension 9 ayant une taille et une rigidité suffisante pour permettre la préhension. 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. 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 welding zone between the first and second and second tubular body 4,5, said gripping area 9 having sufficient size and stiffness to allow gripping.
La zone de soudage 8 correspond à la zone de la plaquette 7 qui sera placée entre les parois de la poche de perfusion. Comme illustrée sur la figure 2, cette zone de soudage est pourvue de nervures de soudage 10 afin de faciliter le soudage des parois de la poche sur le connecteur 3. Les nervures de soudage 10 sont disposées sur toute la longueur de la plaquette, perpendiculairement à l'axe des corps tubulaires 4,5. 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.
L'épaisseur des nervures de soudage 1 0 est de l'ordre de 0,5 mm. Le nombre de nervures de soudage dépend de la taille de la zone de soudage 8 et de la taille desdites nervures 1 0. Sur la figure 2, quatre nervures de soudage 1 0 sont représentées. Avantageusement et comme représenté sur la figure 2, lorsque la plaquette 7 possède une épaisseur substantiellement constante sur toute sa longueur, l'épaisseur des nervures de soudage 10 s'accroît en direction des corps tubulaires 4,5 présentant ainsi, en coupe transversale par rapport à l'axe des corps tubulaires 4,5, la forme générale d'une ellipse effilée autour desdits corps (figure 4). 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 welding zone 8 and the size of said ribs 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).
Comme représenté sur les figures 2 et 3, chaque extrémité transversale de la plaquette 7 formant l'embase 6 se prolonge par une languette 1 1 . Ces languettes 1 1 possèdent une épaisseur réduite par rapport à celle de la plaquette 7, par exemple de l'ordre de 0,25 mm. Ces languettes 1 1 améliorent le soudage des parois de la poche de perfusion sur le connecteur 3. 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.
La zone de préhension 9 de la plaquette 7 prolonge la zone de soudage 8. Cette zone de préhension 9 est notamment pleine, c'est-à-dire qu'elle ne possède pas d'ouverture. Cette zone de préhension 9 permet à un utilisateur de saisir la poche 1 entre ses doigts. Lors de la fabrication de la poche, cette zone de préhension 9 peut également être saisie par une machine pour automatiser la fabrication. En outre, cette zone de préhension 9 limite la fragilité du connecteur engendrée par la finesse de l'embase. 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.
Avantageusement et comme représenté sur les figures 2 et 3, la zone de préhension 9 est pourvue de nervures de préhension 12. Ces nervures de préhension 12 s'étendent perpendiculairement à l'axe des corps tubulaires 4,5. 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.
Ces nervures de préhension 12, par exemple au nombre de quatre, possèdent une épaisseur inférieure à celle des nervures de soudage 10. Par exemple, les nervures de préhension 12 ont une épaisseur de l'ordre de 0,25 mm. Dans une réalisation particulière, un élément de renforcement 13 est arrangé dans la zone de préhension 9 à distance de la zone de soudage 8 de la plaquette 7. Cet élément de renforcement est positionné entre les deux corps tubulaires 4,5, perpendiculairement à l'axe de chacun des corps tubulaires 4,5. Ce positionnement limite ainsi la déformation du connecteur 3 dans le plan défini par les axes des corps tubulaires. Cet élément de renforcement 13, en coopération avec la zone de préhension 9, prévient la déformation du connecteur 3 et notamment des corps tubulaires 4,5 lors des étapes de transport, stockage, soudage et stérilisation. En effet, l'embase 6 étant formée d'une plaquette 7, et donc étant substantiellement fine, celle-ci est fragile et peut se casser ou se déformer facilement. La présence de cet élément de renforcement 13 augmente la solidité du connecteur 3. De plus, lors de la fabrication et notamment le soudage des poches, cet élément de renforcement 13 permet à une machine de positionner correctement et de manière reproductible, le connecteur 3 en vue de son soudage aux parois de la poche de perfusion. Selon la figure 2, l'élément de renforcement 13 se présente sous forme d'une nervure de renforcement. Par exemple, la nervure de renforcement présente une épaisseur de l'ordre de 1 ,8 mm. 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 in position. view of 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.
Comme représenté sur les figures 4 et 5, chacune des faces de la plaquette 7 formant l'embase 6 comprend des nervures de soudage 10, des nervures de préhension 12 et une nervure de renforcement 13. 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.
Comme représenté en coupe sur la figure 3, le connecteur comprend un premier corps tubulaire 4 et un deuxième corps tubulaire 5, formant chacun un orifice d'accès au volume intérieur de la poche. 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.
Le premier corps tubulaire 4, formant notamment un site de perfusion, est équipé d'une douille 14 présentant une cloison transversale perforable 15 destinée à assurer la fermeture étanche de l'orifice d'accès, d'un obturateur perforable 16 disposé de façon étanche sur ladite cloison transversale 15, et d'une coiffe 17 destinée à compresser sur le corps tubulaire 4 ledit obturateur perforable 16 monté sur ladite douille 14. Sur les figures 3 et 8, la douille comprend un rebord 18 comprimé sur le bord du premier corps tubulaire 4. En particulier, la douille 14 est formée d'un élément substantiellement cylindrique présentant à son extrémité aval le rebord 18 dirigé vers l'extérieur de la douille 14. 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, a perforable shutter 16 arranged in a sealed manner 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. In FIGS. 3 and 8, the bushing comprises a flange 18 compressed on the edge of the first tubular body 4. In particular, the bushing 14 is formed of a substantially cylindrical element having at its downstream end the flange 18 directed towards the outside of the socket 14.
La cloison transversale 15 de la douille 14 se situe notamment dans la partie aval de ladite douille 14, en particulier à l'extrémité aval. Par exemple, la cloison transversale 15 courbe se prolonge vers l'extérieur de la douille pour former ledit rebord 18. The transverse wall 15 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 18.
Cette douille 14 est montée en force à l'intérieur du premier corps tubulaire 4, le rebord 18 de la douille reposant sur l'extrémité aval dudit premier corps tubulaire 4. Ainsi, la cloison transversale 15 de la douille 14 ferme hermétiquement le premier corps tubulaire 4 de sorte à empêcher, avant perforation, le passage du fluide contenu dans la poche vers l'extérieur de ladite poche. This bushing 14 is mounted in force inside the first tubular body 4, the flange 18 of the bushing resting on the downstream end of said first tubular body 4. Thus, the transverse partition 15 of the bushing 14 hermetically closes the first body tubular 4 so as to prevent, before perforation, the passage of the fluid contained in the pocket to the outside of said pocket.
Afin d'augmenter l'étanchéité entre la douille 14 et ledit premier corps tubulaire 4, la partie amont de la douille 14, avant assemblage dans le premier corps tubulaire 4, est évasée, c'est-à-dire que le diamètre extérieur amont de la douille 14 est légèrement supérieur à son diamètre extérieur aval. 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 bushing 14 is slightly greater than its downstream outside diameter.
La cloison transversale 15 est perforable, notamment par un perforateur 36 comme représenté sur la figure 1 1 , ou par une canule. La cloison transversale 15 se présente sous la forme d'une paroi mince, de l'ordre de 0,25 mm, réalisée dans le même matériau que l'élément cylindrique de la douille 14. The transverse partition 15 is perforable, in particular by a perforator 36 as shown in FIG. 11, 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.
L'obturateur perforable 16 est disposé de façon étanche sur la cloison transversale 15 de la douille, c'est-à-dire du côté aval de la cloison. Ainsi, la cloison transversale 15, avant perforation, empêche également le contact direct du fluide contenu dans la poche de perfusion avec l'obturateur perforable 16. 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. Thus, the transverse partition 15, before perforation, also prevents the direct contact of the fluid contained in the infusion bag with the perforable shutter 16.
L'obturateur perforable 16 comprend une membrane en élastomère, caoutchouc ou autre matériau analogue, pouvant être traversée par un perforateur et se refermer d'elle-même une fois le perforateur enlevé. Le perforateur est par exemple celui d'un perfuseur. The perforable shutter 16 comprises a membrane of elastomer, rubber or other similar material, which can be traversed by a perforator and close by itself once the perforator has been removed. The perforator is for example that of a perfusor.
En particulier, comme représenté sur les figures 8 et 12, l'obturateur perforable 16 possède un corps substantiellement cylindrique de hauteur relativement faible par rapport au diamètre. Le corps présente un épaulement prenant appui sur le rebord 18 de la douille 14 lorsque l'obturateur perforable 16 est monté dans ladite douille. La paroi transversale 21 de la coiffe 17 compresse l'obturateur perforableIn particular, as shown in FIGS. 8 and 12, the perforable shutter 16 has a substantially cylindrical body of relatively small height relative to the diameter. The body has a shoulder bearing on the flange 18 of the sleeve 14 when the perforable shutter 16 is mounted in said sleeve. The transverse wall 21 of the cap 17 compresses the pierceable shutter
16 au niveau de cet épaulement. La partie centrale de la surface aval dudit corps présente une saille en forme de disque légèrement courbe vers l'intérieur de la douille 14. Et, selon l'invention, la surface amont dudit corps est substantiellement courbe. 16 at that shoulder. The central portion of the downstream surface of said body has a disk-shaped scar slightly curved towards the inside of the sleeve 14. And, according to the invention, the upstream surface of said body is substantially curved.
Dans une réalisation particulière, la douille 14 et l'obturateur perforable 16 forment une pièce unitaire. Notamment, la douille 14 et l'obturateur perforable 16 sont soudés ensemble de façon inséparable. Par exemple, la douille 14 et l'obturateur perforable 16 sont formés par moulage par bi-injection. 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.
Le premier corps tubulaire 4 est également équipé d'une coiffe 17 destinée à compresser ledit obturateur perforable 16 et ladite douille 14 sur le corps tubulaire 4. Comme le montre la figure 3, la coiffe 17 recouvre ledit premier corps tubulaire 4. 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.
Pour cela, le premier corps tubulaire 4 et la coiffe 17 présentent des saillies d'encliquetage complémentaires 19,20, représentées en particulier sur la figure 3. For this, the first tubular body 4 and the cap 17 have complementary latching projections 19,20, shown in particular in FIG. 3.
Selon une réalisation, la coiffe 17 est formée d'une paroi transversale 21 se prolongeant en une jupe périphérique 22, visibles sur la figure 9. Lorsque la coiffeAccording to one embodiment, the cap 17 is formed of a transverse wall 21 extending into a peripheral skirt 22, visible in FIG.
17 est placée sur le premier corps tubulaire 4, comme sur la figure 3, la paroi transversale 21 vient écraser l'obturateur perforable 16 afin de le maintenir fermement serré dans ledit premier corps tubulaire 4. En outre, la coiffe 17 présente une ouverture 23 agencée pour permettre l'introduction d'un perforateur dans l'obturateur. L'ouverture 23 est agencée dans la paroi transversale 21 de la coiffe 17 comme montré sur les figures 9 et 1 1 . Selon l'invention, afin de garantir l'étanchéité du connecteur 3 et donc l'absence de contamination du fluide contenu dans la poche de perfusion, la surface de la cloison transversale 15 de la douille 14 en contact avec l'obturateur perforable 16 est courbe de sorte à augmenter localement la compression dudit obturateur perforable 16 entre ladite coiffe 17 et ledit corps tubulaire 4, notamment pendant la perforation. 17 is placed on the first tubular body 4, as in FIG. 3, the transverse wall 21 crushes the perforable shutter 16 in order 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. According to the invention, in order to guarantee the sealing of the connector 3 and therefore 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 curve so as to locally increase the compression of said perforable shutter 16 between said cap 17 and said tubular body 4, especially during the perforation.
Notamment, la forme courbe augmente la compression de la partie de l'obturateur perforable 16 qui est disposée entre la paroi transversale 21 de la coiffe 17 et le rebord 18 de la douille 14. 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.
En coupe axiale, comme sur les figures 3, 8 et 12, la forme de la cloison transversale 15 n'est pas droite, mais courbe, c'est-à-dire que la zone centrale de la cloison transversale 15 n'est pas au même niveau que la zone périphérique de ladite cloison transversale 15. In axial section, as in Figures 3, 8 and 12, 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.
Cette forme bombée de la cloison transversale 15 en contact étroit avec l'obturateur perforable 16 va augmenter la contrainte verticale exercée par la coiffe 17 sur l'obturateur perforable 16 lors du placement de la coiffe 17 sur le premier corps tubulaire 4. 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.
En particulier, la surface de ladite cloison transversale 15 est courbe vers l'intérieur de la douille 14, c'est-à-dire vers l'amont. Autrement dit, la cloison transversale 15 est convexe lorsque la poche de perfusion est utilisée, c'est-à- dire lorsque la poche est disposée pour que le fluide dans la poche s'écoule de l'intérieur de l'extérieur. 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 septum 15 is convex when the infusion bag is used, i.e., when the bag is disposed so that the fluid in the bag flows from the inside of the outside.
En variante représentée sur les figures 1 1 et 12, la surface de ladite cloison transversale 15 est courbe vers l'extérieur de la douille 14, c'est-à-dire vers l'aval. Autrement dit, la cloison transversale 15 est concave lorsque la poche de perfusion est utilisée, c'est-à-dire lorsque la poche est disposée pour que le fluide dans la poche s'écoule de l'intérieur de l'extérieur. Comme l'obturateur perforable 16 est disposé de façon étanche sur la cloison transversale 15 de la douille 14, la surface de l'obturateur perforable 16 en contact avec la cloison transversale 15 présente une forme complémentaire courbe. La surface de l'obturateur perforable 16 en contact avec la coiffe 17 et notamment la paroi transversale 21 de la coiffe 17 est plane. L'obturateur perforable 16 est ainsi substantiellement plan-convexe ou plan-concave. Alternatively shown in Figures 1 1 and 12, the surface of said transverse partition 15 is curved outwardly of the sleeve 14, that is to say downstream. In other words, the transverse septum is concave when the infusion bag is used, i.e., when the bag is disposed for the fluid in the bag to flow from the inside of the outside. 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.
L'étanchéité entre la coiffe 17 et l'obturateur perforable 16 est encore accrue lorsque la douille 14 présente une forme évasée comme définie ci-dessus. 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.
Selon une réalisation représentée sur les figures 3 et 9, le connecteur 3 comprend en outre un bouchon 24 présentant une zone de faiblesse 25 associée à la coiffe 17, ladite zone de faiblesse 25 étant agencée pour pouvoir être rompue par une action manuelle de sorte à séparer le bouchon 24 de ladite coiffe 17 et permettre l'accès à l'ouverture de la coiffe 17. 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.
Le bouchon 24 protège l'obturateur perforable 16 jusqu'au moment où l'utilisateur souhaite perforer ledit obturateur par un perforateur. Notamment, la zone de faiblesse 25 du bouchon 24 est susceptible d'être rompue lors d'une sollicitation latérale ou rotationnelle. The plug 24 protects the perforable shutter 16 until the user wishes 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.
Le premier corps tubulaire 4 est avantageusement rigide afin d'éviter d'être déformé ou tordu lors de l'ouverture du bouchon 24. The first tubular body 4 is advantageously rigid in order to avoid being deformed or twisted when opening the stopper 24.
Avantageusement, le bouchon 24 comprend une palette 26 de forme et de taille suffisante pour qu'un utilisateur puisse la saisir entre ses doigts. La zone de faiblesse 25 est rompue en exerçant un mouvement de rotation ou un mouvement latéral sur cette palette 26, rendant accessible l'ouverture 23 de la coiffe 17 et donc l'obturateur perforable 16. 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.
La zone de faiblesse 25 est par exemple une zone de faible épaisseur, par exemple de l'ordre de 0,1 mm. The zone of weakness 25 is, for example, a zone of small thickness, for example of the order of 0.1 mm.
En relation avec la figure 3, afin d'éviter le basculement de la coiffe 17, notamment lors de la rupture de la zone de faiblesse 25 du bouchon 24, le premier corps tubulaire 4 présente sur sa surface externe une collerette 27 au regard de laquelle la coiffe 17 est disposée. 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 stopper 24, the first tubular body 4 has on its outer surface a collar 27 with respect to which the cap 17 is arranged.
En alternative ou en complément, la coiffe 17 est bloquée en rotation sur le corps tubulaire 4. A cet effet, et selon les figures 6 et 7, le corps tubulaire 4 présente des ailettes axiales 28 réparties sur sa surface externe qui s'engagent dans des stries 29 correspondantes arrangées sur la surface interne de la coiffe 17, de sorte à bloquer en rotation la coiffe 17 sur le corps tubulaire 4. Les ailettes 28 sont en particulier disposées entre la collerette 27 et la saillie d'encliquetage 19 du premier corps tubulaire 4. En particulier mais pas nécessairement, les ailettes 28 sont en contact avec ladite collerette 27. Par exemple, le nombre d'ailettes 28 est compris entre 1 et 10, notamment 8. Ces ailettes 28 s'engagent dans des stries 29 pourvues sur la surface interne de la coiffe 17. Le nombre de stries 29 est égal ou supérieur au nombre d'ailettes 28. Un plus grand nombre de stries 29 facilitent le montage de la coiffe 17 sur le corps tubulaire 4. En relation avec la figure 3, le deuxième corps tubulaire 5, formant notamment un site d'injection, est équipé d'un embout 30 et d'un obturateur perforable 31 disposé de façon étanche dans ledit embout 30. Le deuxième corps tubulaire 5 est avantageusement souple pour permettre un clampage manuel ou automatique afin de contrôler l'introduction d'un additif dans la poche. En variante, le deuxième corps tubulaire est équipé d'un obturateur de type "bouchon clou" (non représenté). In alternative 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 rotation 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 body 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, in particular 8. These fins 28 engage in streaks 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 connection with the figure e 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).
L'embout 30 présente une partie cylindrique amont 32 et une partie cylindrique aval 33, la partie amont 32 étant destinée à être introduite de façon étanche dans le deuxième corps tubulaire 5 et la partie aval 33, de diamètre extérieur légèrement supérieur au diamètre extérieur de la partie amont 32, reste à l'extérieur dudit deuxième corps tubulaire 5 en prenant appui sur le bord dudit deuxième corps tubulaire 5. Le diamètre intérieur de la partie amont 32 est avantageusement inférieur au diamètre intérieur de la partie aval 33 de sorte à créer une portée 34 sur laquelle repose l'obturateur perforable 31 . 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.
L'obturateur perforable 31 du deuxième corps tubulaire 5 comprend une membrane en élastomère, caoutchouc ou autre matériau analogue, pouvant être traversée par une aiguille et se refermer d'elle-même une fois l'aiguille enlevée. L'aiguille est par exemple celle d'une seringue contenant une solution médicamenteuse à additionner au fluide contenu dans la poche de perfusion ou celle d'un dispositif de transfert permettant de transférer le contenu médicamenteux d'un flacon dans ladite poche de perfusion. 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.
Selon une réalisation, le deuxième corps tubulaire 5 est pourvu d'une cloison transversale et perforable 35, destinée à assurer la fermeture étanche du deuxième corps tubulaire 5, fermant de façon étanche ledit corps tubulaire 5 jusqu'à la perforation de ladite cloison 35. 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.
Avantageusement, la cloison 35 du deuxième corps tubulaire 5 est située à proximité de l'extrémité amont dudit embout 30. L'assemblage d'un tel connecteur 3 est particulièrement aisée et ne nécessite que peu d'étapes. Selon un mode particulier de fabrication et d'assemblage, on réalise par moulage les différentes pièces constituant le connecteur et on les assemble mécaniquement. Notamment, on réalise par moulage par injection d'une part un connecteur 3 comprenant un premier et deuxième corps tubulaires 4,5 et une embase 6 s'étendant autour desdits premier et deuxième corps 4,5 tels que décrits ci-dessus et représentés sur la figure 6 et d'autre part, la coiffe 17 pourvue d'un bouchon 24. La douille 14 et l'obturateur perforable 16 sont réalisés d'une seule pièce par moulage par bi-injection. 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, injection molding is carried out on the one hand by 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 represented on Figure 6 and secondly, the cap 17 provided with a plug 24. The sleeve 14 and the perforable shutter 16 are made in one piece by bi-injection molding.
Pour assembler le site de perfusion, il suffit d'insérer la douille 14 et l'obturateur perforable 16 dans le premier corps tubulaire 4, puis d'encliqueter la coiffe 17. To assemble the perfusion site, it is sufficient to insert the sleeve 14 and the perforable shutter 16 in the first tubular body 4, then to snap the cap 17.
De même, le site d'injection est assemblé en insérant l'embout 30 pourvu d'un obturateur perforable 31 dans le deuxième corps tubulaire 5. Une fois le connecteur assemblé, il est stérilisé, notamment par chaleur. En choisissant les matériaux appropriés, les différentes pièces du connecteur 3 sont soudées thermiquement lors de cette étape de stérilisation, fournissant ainsi un connecteur totalement étanche et facile à souder. Similarly, the injection site is assembled by inserting the tip 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

REVENDICATIONS
1 . Connecteur (3) pour poche de perfusion comprenant au moins un premier corps tubulaire (4) formant un orifice d'accès, ledit corps tubulaire (4) étant équipé d'une douille (14) présentant une cloison transversale perforable (15) destinée à assurer la fermeture étanche de l'orifice d'accès, d'un obturateur perforable (16) disposé de façon étanche sur ladite cloison transversale (15), et d'une coiffe (17) destinée à compresser sur le corps tubulaire (4) ledit obturateur perforable (16) monté sur ladite douille (14), caractérisé en ce que la surface de ladite cloison transversale (15) en contact avec l'obturateur perforable (16) est courbe de sorte à augmenter localement la compression dudit obturateur perforable (16) entre ladite coiffe (17) et ledit corps tubulaire (4). 1. Connector (3) for infusion bag comprising at least a first tubular body (4) forming an access port, said tubular body (4) being equipped with a socket (14) having a perforable transverse partition (15) for sealing the access opening, 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 bushing (14), characterized in that the surface of said transverse partition (15) in contact with the perforable shutter (16) is curved so as to locally increase the compression of said perforable shutter ( 16) between said cap (17) and said tubular body (4).
2. Connecteur selon la revendication 1 , caractérisé en ce que la coiffe (17) présente une ouverture (23) agencée pour permettre l'introduction d'une canule dans l'obturateur perforable (16). 2. Connector according to claim 1, characterized in that the cap (17) has an opening (23) arranged to allow the introduction of a cannula into the perforable shutter (16).
3. Connecteur selon la revendication 2, caractérisé en ce qu'il comprend en outre un bouchon (24) présentant une zone de faiblesse (25) associée à la coiffe (17), ladite zone de faiblesse (25) étant agencée pour pouvoir être rompue par une action manuelle de sorte à séparer le bouchon (24) de ladite coiffe (17) et permettre l'accès à l'ouverture (23) de la coiffe (17). 3. Connector according to claim 2, characterized in that it further comprises a plug (24) having a zone of weakness (25) associated with the cap (17), said zone of weakness (25) being arranged to be able to be broken by a manual action so as to separate the plug (24) of said cap (17) and allow access to the opening (23) of the cap (17).
4. Connecteur selon l'une quelconque des revendications 1 à 3, caractérisé en ce que la douille (14) présente un rebord (18) comprimé sur le bord du premier corps tubulaire (4). 4. Connector according to any one of claims 1 to 3, characterized in that the sleeve (14) has a flange (18) compressed on the edge of the first tubular body (4).
5. Connecteur selon l'une quelconque des revendications 1 à 4, caractérisé en ce que la surface de ladite cloison transversale (15) est courbe vers l'intérieur de la douille (14). 5. Connector according to any one of claims 1 to 4, characterized in that the surface of said transverse partition (15) is curved towards the inside of the sleeve (14).
6. Connecteur selon l'une quelconque des revendications 1 à 5, caractérisé en ce que la douille (14) et l'obturateur perforable (16) forment une pièce unitaire. 6. Connector according to any one of claims 1 to 5, characterized in that the sleeve (14) and the perforable shutter (16) form a unitary piece.
7. Connecteur selon l'une quelconque des revendications 1 à 6, caractérisé en ce que le corps tubulaire (4) et la coiffe (17) présentent des saillies d'encliquetage (19,20) complémentaires. 7. Connector according to any one of claims 1 to 6, characterized in that the tubular body (4) and the cap (17) have complementary latching projections (19,20).
8. Connecteur selon l'une quelconque des revendications 1 à 7, caractérisé en ce que le corps tubulaire (4) présente sur sa surface externe une collerette (27) au regard de laquelle la coiffe (17) est disposée. 8. Connector according to any one of claims 1 to 7, characterized in that the tubular body (4) has on its outer surface a collar (27) with respect to which the cap (17) is disposed.
9. Connecteur selon l'une quelconque des revendications 1 à 8, caractérisé en ce que la coiffe (17) est bloquée en rotation sur le corps tubulaire (4). 9. Connector according to any one of claims 1 to 8, characterized in that the cap (17) is locked in rotation on the tubular body (4).
10. Connecteur selon la revendication 9, caractérisé en ce que le corps tubulaire (4) présente des ailettes axiales (28) réparties sur sa surface externe qui s'engagent dans des stries (29) correspondantes arrangées sur la surface interne de la coiffe (17), de sorte à bloquer en rotation la coiffe (17) sur le corps tubulaire (4). 10. Connector according to claim 9, characterized in that the tubular body (4) has axial fins (28) distributed on its outer surface which engage in grooves (29) corresponding arranged on the inner surface of the cap ( 17), so as to lock in rotation the cap (17) on the tubular body (4).
1 1 . Connecteur selon l'une quelconque des revendications 1 à 10, caractérisé en ce qu'il comprend en outre une embase (6) s'étendant autour dudit corps tubulaire (4), ladite embase comprenant une zone de soudage (8) destinée à être soudée aux parois d'une poche de perfusion. 1 1. Connector according to any one of claims 1 to 10, characterized in that it further comprises a base (6) extending around said tubular body (4), said base comprising a welding zone (8) intended to be welded to the walls of an infusion bag.
12. Connecteur selon la revendication 1 1 , caractérisé en ce qu'il comprend un deuxième corps tubulaire (5), ladite embase s'étendant autour dudit premier et deuxième corps tubulaire (4,5), ladite embase (6) étant formée d'une plaquette (7) comprenant une zone de soudage (8) destinée à être soudée aux parois d'une poche de perfusion et d'une zone de préhension (9) s'étendant à l'extérieur de ladite zone de soudage (8) entre le premier et deuxième corps tubulaire (4,5), ladite zone de préhension (9) ayant une taille et une rigidité suffisante pour permettre la préhension. 12. Connector according to claim 1 1, characterized in that it comprises a second tubular body (5), said base extending around said first and second tubular body (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 and a gripping zone (9) extending outside said welding zone (8); ) between the first and second tubular body (4,5), said gripping area (9) having a size and rigidity sufficient to allow gripping.
13. Poche de perfusion comprenant un connecteur (3) selon l'une quelconque des revendications 1 à 12. 13. Infusion bag comprising a connector (3) according to any one of claims 1 to 12.
PCT/FR2014/051194 2013-05-22 2014-05-21 Stopper of a connector for an infusion bag WO2014188128A1 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
EP14731699.6A EP2999450B1 (en) 2013-05-22 2014-05-21 Stopper of a connector for an infusion bag

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
FR1354584A FR3005855B1 (en) 2013-05-22 2013-05-22 SHUTTER OF CONNECTOR FOR INFUSION POUCH
FR1354584 2013-05-22

Publications (1)

Publication Number Publication Date
WO2014188128A1 true WO2014188128A1 (en) 2014-11-27

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EP (1) EP2999450B1 (en)
FR (1) FR3005855B1 (en)
WO (1) WO2014188128A1 (en)

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Publication number Priority date Publication date Assignee Title
JP7277381B2 (en) 2017-12-07 2023-05-18 藤森工業株式会社 Bag with port and bag with cap

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WO2023148320A1 (en) * 2022-02-04 2023-08-10 Fresenius Kabi Deutschland Gmbh Infusion bag, and method for producing same

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Publication number Priority date Publication date Assignee Title
FR1202997A (en) * 1958-04-22 1960-01-14 Self-closing closure for all bottles or bags, mainly medical, in plastic
EP0011144A1 (en) 1978-10-27 1980-05-28 Biotest-Serum-Institut GmbH Closure for a plastic bag containing an infusion solution
US4632673A (en) 1983-06-15 1986-12-30 Hantaaki Oy Pierceable port for containers
US6022339A (en) * 1998-09-15 2000-02-08 Baxter International Inc. Sliding reconstitution device for a diluent container
DE10223560A1 (en) 2002-05-27 2003-12-18 Fresenius Kabi De Gmbh Connector for packaging containing medical liquids and packaging for medical liquids
WO2006071781A2 (en) 2004-12-23 2006-07-06 Hospira, Inc. Port closure system for intravenous fluid container

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR1202997A (en) * 1958-04-22 1960-01-14 Self-closing closure for all bottles or bags, mainly medical, in plastic
EP0011144A1 (en) 1978-10-27 1980-05-28 Biotest-Serum-Institut GmbH Closure for a plastic bag containing an infusion solution
US4632673A (en) 1983-06-15 1986-12-30 Hantaaki Oy Pierceable port for containers
US6022339A (en) * 1998-09-15 2000-02-08 Baxter International Inc. Sliding reconstitution device for a diluent container
DE10223560A1 (en) 2002-05-27 2003-12-18 Fresenius Kabi De Gmbh Connector for packaging containing medical liquids and packaging for medical liquids
WO2006071781A2 (en) 2004-12-23 2006-07-06 Hospira, Inc. Port closure system for intravenous fluid container

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP7277381B2 (en) 2017-12-07 2023-05-18 藤森工業株式会社 Bag with port and bag with cap

Also Published As

Publication number Publication date
EP2999450A1 (en) 2016-03-30
FR3005855B1 (en) 2015-06-26
FR3005855A1 (en) 2014-11-28
EP2999450B1 (en) 2018-10-31

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