EP3297596A1 - Module de raccordement pour conduire un fluide médical - Google Patents

Module de raccordement pour conduire un fluide médical

Info

Publication number
EP3297596A1
EP3297596A1 EP16727339.0A EP16727339A EP3297596A1 EP 3297596 A1 EP3297596 A1 EP 3297596A1 EP 16727339 A EP16727339 A EP 16727339A EP 3297596 A1 EP3297596 A1 EP 3297596A1
Authority
EP
European Patent Office
Prior art keywords
ansetzteil
sealing element
connecting piece
opening
attached
Prior art date
Legal status (The legal status 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 status listed.)
Pending
Application number
EP16727339.0A
Other languages
German (de)
English (en)
Inventor
Torsten Brandenburger
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Fresenius Kabi Deutschland GmbH
Original Assignee
Fresenius Kabi Deutschland 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 Fresenius Kabi Deutschland GmbH filed Critical Fresenius Kabi Deutschland GmbH
Publication of EP3297596A1 publication Critical patent/EP3297596A1/fr
Pending legal-status Critical Current

Links

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
    • A61J1/20—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
    • 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
    • A61J1/2048—Connecting means
    • 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
    • A61J1/1406—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
    • A61J1/20—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
    • 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
    • A61J1/202—Separating means
    • A61J1/2027—Separating means having frangible parts
    • 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
    • A61J1/202—Separating means
    • A61J1/2044—Separating means having slits
    • 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
    • A61J1/2096—Combination of a vial and a syringe for transferring or mixing their contents

Definitions

  • Terminal assembly for conducting a medical fluid
  • the invention relates to a connection assembly for conducting a medical fluid according to the preamble of claim 1.
  • connection assembly can be used, for example, on a container for medical liquids, for example in the form of a flexible bag, an ampoule or another bottle container, for conducting a medical liquid into the container or removing it from the container.
  • a connection module can also be called a connector for short,
  • a self-sealing membrane is inserted into a channel-shaped recess of a connection part.
  • the channel-shaped recess is closed by a break-off part that can be broken off to release the channel-shaped recess of the connecting part, so that a syringe with a connection piece can be attached to the connection part.
  • the membrane By attaching the syringe to the connector part, the membrane can be opened so that a liquid can be conveyed into or out of the container.
  • a hollow body with a tip is arranged on one side of a membrane, which faces away from a syringe to be attached to the membrane.
  • the hollow body helps to open the membrane.
  • a valve unit having a hollow body which facilitates opening of the membrane is also shown in WO 93/11828 A1.
  • the document shows a needle-free valve assembly having a tubular body defining an internal cavity.
  • the valve unit also includes a hollow spike disposed in the cavity with a closed tip.
  • the valve unit further comprises an elastic
  • Silicone gasket which closes the valve unit and covers the tip of the spike.
  • the seal has a sealing head, a conical sidewall and a lower one
  • Such connectors serve, for example, to provide so-called needle-free access to a container containing a medical fluid, for example a bag or a bottle, in order to fill or remove fluid from the container via the access.
  • a needle-free access allows access to the container using a conveyor that has no injection needle.
  • a connecting piece of a conveyor in the form of a syringe is attached to a slot opening of a sealing element, in order to open the slot opening in this way and to allow a flow between the conveyor and the container.
  • US 2010/0298782 A1 describes an intravascular valve component which has a valve housing and a flexible, pressure-operable flow control valve.
  • the housing includes a near and a remote housing part, which are interconnected.
  • the valve comprises a slotted central valve wall and an annular flange surrounding the valve wall.
  • the flange has a radially extending flange wall and a projection extending axially from the flange wall. The projection engages a portion of the valve housing to restrict radial movement of the valve relative to the housing.
  • Object of the present invention is to provide a connector assembly for guiding a medical fluid available, which allows a reliable hold, but also a certain mobility of the sealing element. In particular, the flow should not be significantly affected.
  • a further object is to provide a terminal assembly in which a wiping or dabbing of a sealing element for the purpose of disinfection is made possible in a simple manner.
  • the attachment piece has an opening into which the connector engages when attached to the connector Anmineeil.
  • the terminal assembly also includes a sealing element for sealing a transition between the fitting and the attachment part.
  • the sealing element can be used in an insertion direction into the opening of the Anmineeils such that when attached to the connector Anmineeil the sealing element between the Anmineeil and the connector is held.
  • an interior of the sealing element is free of a body with a tip, which is to assist the opening of the sealing element.
  • the sealing element has a sealing head, which closes the opening of the Anmaneils against a liquid passage when attached to the fitting Anmaneils, and a subsequent to the sealing head body, which can be arranged or arranged with radial distance to Anmaneil in the opening.
  • the sealing element has
  • a flange which is spaced apart from the body of the sealing element and extends radially outwards along the direction of insertion to the shoulder, which is held between the attachment part and the connecting piece when the attachment part is attached to the connection piece, preferably by clamping
  • the sealing element is held at attached to the fitting Anmineeil so between the Andaneil and the connector so that the flange rests with its underside on a support surface of the connector and its upper side at least partially exposed.
  • the sealing element comprises a foot section which, viewed axially along the insertion direction (E), adjoins the body below the flange and engages in an associated recess in the connection piece when the attachment part is attached to the connection piece.
  • the sealing element is held in clamped manner when attached to the fitting Anmineeil between the Anmineeil and the connector, so that a transition between the Anmineeil and the connector is sealed in liquid-tight manner.
  • the sealing element in this case has a circumferential around the direction of insertion around the shoulder, which projects radially outwardly beyond the sealing head and - rests on an attached contact surface of the Anöneils - attached to the fitting Anöneil. Over the shoulder, the sealing element is thus supported in particular axially along the insertion direction relative to the Anmineeil, so that over the shoulder, the sealing element is fixed axially relative to Anmineeil.
  • the diameter of the sealing element in the region of the shoulder in a range of 4 mm to 10 mm, preferably from 6 mm to 8 mm. Characterized in that the sealing element is supported with the shoulder on the one hand on Anmineeil and on its flange and the foot portion on the other hand on the connector, a defined, secured position of the sealing element can be ensured within the opening of Anangeeils.
  • the sealing element has a total of preferably a rotationally symmetrical shape, wherein different portions of the sealing element may have different diameters.
  • the shoulder adjoining body is disposed in the opening of the attachment part with radial play, so that there is a space around the body within the opening of the attachment part into which the sealing element can deform when a delivery device is attached to the attachment part.
  • the body is adjoined by the radially outwardly projecting flange. This protrudes outward over the body.
  • the flange When attached to the connector Anmineeil the flange is clamped or clamped between the Anmineeil and the connector so that the flange itself is not clamped.
  • This indirect clamping holder of the flange is achieved in that the sealing element is supported with the shoulder on the one hand on Anangeeil and on its flange and / or the foot portion on the other hand on the connector.
  • the flange lies with its underside on a support surface of the connector only on and its top is, preferably in sections or completely, free.
  • the flange is thus used to fix the sealing element between the attachment part and the connection piece, wherein the flange is preferably arranged on an end of the body facing away from the shoulder and thus the sealing element with the shoulder on one side of the body and with the flange on the other Side of the body relative to the Animieil and the connection piece is supported.
  • the diameter of the sealing element is greater at the flange than at the shoulder.
  • the Diameter of the flange in a range of 5 mm to 1 1 mm, preferably from 7 mm to 9 mm.
  • the sealing element has the fact that the flange itself is not held by clamping yet a certain mobility.
  • the sealing head when connecting the syringe, the sealing head can first be pushed downwards into the housing from the connection nozzle of the syringe.
  • the side wall of the sealing element can dodge radially.
  • the sealing element can be opened by the connection piece of the syringe penetrates into a slot opening in the sealing head.
  • the radial compensation movement of the side wall can be supported by the movable arrangement of the flange.
  • a radially outer portion of the flange may be held clamped between an abutment surface of the fitting and a protrusion of the attachment part projecting radially inwardly when the attachment part is attached to the attachment piece, for example initially.
  • the projection is an annular projection.
  • the annular projection may extend completely or only in sections over the circumference of the sealing element.
  • the annular projection can thus effect, on the one hand, a section-wise clamping fixing of the sealing element between the attachment part and the connecting piece.
  • the annular projection can support the (centered) position of the sealing element within the opening with a radial spacing of the wall of the attachment part surrounding the sealing element.
  • the connection between the connection piece and the attachment part can also be provided via the annular projection.
  • the sealing element is convex on an outer side, which faces away from the connection piece when the attachment part is attached to the connection piece. It is also conceivable and possible, however, that the sealing element is curved on the outside substantially flat or concave inwards.
  • the outer side can in particular in a state in which a conveyor is connectable to the Anmineeil beyond the Anmineeil outwardly projecting or be flush with a surface of Anangeeils, so that before applying the conveyor readily on the outside of the sealing element from the outside accessed and wiped or blotted for sterilization purposes can.
  • the attachment part may in this case have a Abbrech Georgia, which is connected in an initial state integral with another, connected to the connector portion of Anöneils and removed from this section, in particular can be canceled to connect a conveyor with the Anmineeil.
  • the sealing element When removed from the Anöneil Abbrech Supplement the sealing element may protrude with its outside to the outside, so that the outside can be wiped or dabbed from the outside.
  • the connection assembly, and in particular also the outside of the sealing element can already be provided in a sterile state in the initial state, ie, if the break-off piece has not yet been broken off.
  • the outside is formed on the sealing head of the sealing element. If, for example, a break-off piece is removed from the attachment part, essentially only the outside of the sealing element is exposed to the outside, which, e.g. protrudes outward in a convexly curved manner and can be wiped off or dabbed in a simple, reliable manner.
  • the upper or outer side of the sealing head has a diameter in a range of 3 mm to 7 mm, preferably 4 mm to 6 mm.
  • the shoulder is preferably arranged on a side facing away from the outside end of the sealing head.
  • no hollow body is provided with a tip to assist the opening of the membrane.
  • the sealing head is adjoined by a preferably cylindrical portion which merges into the shoulder projecting radially outwards over the portion. Preferably, this section has a larger diameter than the sealing head.
  • the body may be joined to the shoulder, preferably cylindrically shaped, with the shoulder projecting radially outwardly beyond the body.
  • the body may have a recess in its outside, preferably provided by or as a step. In particular, there is only a single step in the body.
  • the recess may have a substantially straight bottom.
  • the recess of a cuboid cross-section exhibit. The bottom and the radial opening of the recess may in this case have substantially the same dimensions.
  • the flange may be adjoined by a foot portion projecting from the flange along the direction of insertion and engaging an associated recess of the fitting with an attachment portion attached to the fitting. It is thus created an advantageous connection between the sealing element and the connecting piece with a defined position of the sealing element within the opening of the Anangeeils.
  • the sealing element can thus be supported with the shoulder on one side of the body and with the flange and / or with the foot portion on the other side of the body relative to the Anöneil and the fitting.
  • the sealing element has an overall height in a range of 6 mm to 15 mm, preferably 9 mm to 12 mm.
  • the sealing element preferably has at its sealing head a slot opening, which closed when attached to the fitting Anmineeil against a liquid passage and to open by connecting the conveyor to the Ankaneil is such that a medical fluid can be conveyed through the slot opening.
  • a slot opening By means of such a slot opening thus a needle-free access is provided, by means of which, using a conveyor which has no injection needle, for example, can be accessed on a connected to the connector container.
  • the delivery device can be attached to the sealing element, for example with a connection piece, the connection piece preferably first pushing down the upper side of the sealing element by pressure on the sealing element and then penetrating into the slot opening and thus opening the sealing element to create a throughflow.
  • the conveyor extends at the latest when it is completely attached, for example, screwed, is, preferably with the connection piece, through the slot opening of the sealing element, so that a flow between the conveyor and the container can be done freely by the sealing element.
  • at least 80%, preferably at least 90%, of the opening cross-section in the conveying device through which the liquid transport takes place is released and thus not covered by the seal.
  • the attachment part is preferably integrally formed as a plastic molded part, preferably as a plastic injection molded part.
  • the Anmaneil here has a first portion and a Abbrech Gi.
  • the opening is formed, in which engages when attached to the fitting Anmineeil the connector.
  • the Abbrech consortium is connected in an initial state with the first portion and can be for connecting a conveyor to the Anmineeil of the first section removed, in particular broken off.
  • the sealing element is held on the first portion and closes when broken Abbrech congress the opening of the first section to the outside.
  • the outside of the sealing element faces outward and is preferably projecting outwardly beyond the first section or is flush with the first section.
  • the attachment portion provides a, preferably female, luer fitting.
  • the first section is formed in a concrete embodiment by a connecting portion attachable to the connecting portion and a subsequent to the connecting portion threaded portion.
  • the threaded portion has at least half a thread for making a threaded connection with the conveyor.
  • the threaded connection is provided by a double-threaded.
  • connection element in the form of a union nut of a conveyor such as a Luer-lock syringe
  • the Abbrech Texas Instruments can be connected to produce a Luer-lock connection.
  • the Abbrech Texas Instruments In its initial state, the Abbrech Texas Instruments is connected to the threaded portion and thus closes off the Anmineeil outwards.
  • the Abbrech Georgia can be removed from the threaded portion, in particular be canceled, so that the conveyor can be brought in a screwing manner with its connection element with the threaded portion in connection.
  • the threaded portion and the Abbrech farms are in the initial state advantageously integrally and integrally connected.
  • a Sollbrechstelle for example in the form of a circumferential notch-shaped depression, be provided which allows a defined removal of the Abbrechrios of the threaded portion along a predetermined line by the predetermined breaking point.
  • the sealing element is preferably located with its sealing head in an engagement opening of the threaded portion in such a way that substantially only the outside of the sealing head is accessible from the outside.
  • the sealing element can advantageously be wiped or dabbed on its outside with broken Abbrech mixes on the outside to attach a conveyor under sterile conditions to the attachment part and to connect with the fitting.
  • connection piece preferably engages with a head attached to the attachment part with a head in the opening of the Anmaneils.
  • the connecting piece can advantageously be positively connected to the Anmaneil by, for example, a rotating around the insertion direction positive locking element, for example, a circumferential annular projection at the head of the connector with an associated positive locking element on the side of the Ansetz Anlagens engaged and in this way the Anangeeil relative to the connector axially sets.
  • one or more positive locking elements can be provided on the head, which effect a rotationally fixed fixing of the attachment part on the head.
  • connection assembly and / or the sealing element may be part of a container for medical fluids.
  • the connector is connected to the container and provides access to the container.
  • the connector assembly may be part of a connector to which medical leads may be connected.
  • the terminal assembly may be part of a so-called Y-connector, to the two lines and on the Anöneil also a conveyor can be connected.
  • a sealing element for an embodiment of the above-described connection assembly and / or the connector described above.
  • the sealing element comprises a sealing head and a body adjoining the sealing head, wherein the sealing element at a transition between the sealing head and the body a radially projecting to a direction of insertion via the sealing head shoulder along the insertion in abutment with an associated contact surface within an opening of a Connector can be brought, and a along the direction of insertion to the shoulder spaced, with respect to the body of the sealing element radially outwardly projecting flange, which preferably can be clamped, held in the connector comprises.
  • the flange can rest with its underside on a head of the connector and its top can at least partially exposed.
  • a foot portion which, viewed axially along the insertion direction (E), below the flange adjoins the body, engage with an attachment attached to the fitting in an associated recess in a head of the fitting.
  • connection assembly or an embodiment of the sealing element described above and a conveyor having a connecting piece for attachment to the Anmineeil, wherein attached to the Anmineeil conveyor, the connecting piece, the slot opening of Sealing element penetrates.
  • Figure 1 is a view of a container in the form of a bag with connectors arranged thereon, are attached to the Anangeeile.
  • FIG. 2 shows an exploded view of the connecting pieces and the attachment parts with sealing elements to be arranged therebetween;
  • Fig. 3 is a separate view of a connector with an attached thereto
  • FIG. 4 is a front view of the arrangement of FIG. 3;
  • Fig. 5 is a sectional view in a cross-sectional plane corresponding to
  • Fig. 6 is a separate view of a Anangeeils
  • Fig. 7 is a separate view of a sealing element
  • Fig. 8A is a front view of the fitting
  • Fig. 8B is a side view of the fitting
  • Fig. 9 is a view of the attachment part on the connector, in aborted
  • Fig. 1 1 is the sectional view of Figure 5, broken off Abbrech Division.
  • Fig. 12A is a schematic view of a conveyor in the form of a syringe on the fitting;
  • Fig. 13 is a view of a terminal assembly in the form of a Y-connector.
  • FIG. 14 is an exploded view of the arrangement of FIG. 13th
  • Fig. 1 shows a container 1 in the form of a flexible bag having a bag body 10 for receiving a medical liquid, for example a medicament, a saline or a nutrient solution or the like.
  • the medical fluid can be stored, which can be filled via connectors 1 1, 12 liquid in the container 1 or removed from the container 1.
  • the connecting pieces 1 1, 12 provide access to the container.
  • a first connector 1 1 is hereby designed to allow together with a Anmaneil 2 connecting a conveyor 5 in the form of a syringe (see FIGS. 12A and 12B) to connect via the connector 1 1 a liquid component in the container 1 in to promote.
  • the second connector 12, however, together with a Anangeeil 3 provides access through which, for example, an infusion set to the container 1 can be connected to supply a liquid from the container 1 out of a patient.
  • Fig. 2 shows an exploded view of the terminal assemblies, which are formed by the connecting pieces 1 1, 12, the attachment parts 2, 3 and between the connecting pieces 1 1, 12 and the Ansetz tone 2, 3 sealing elements 4, 6.
  • the connecting pieces 1 1, 12 are to place the container 1 between films and are welded to the films, so that the connecting pieces 1 1, 12 are materially connected to the films.
  • the Anöneile 2, 3 are to complete the container 1 to the fittings 1 1, 12 set so that the sealing elements 4, 6 between the Ansetz tone 2, 3 and the fittings 1 1, 12 come to rest and in this way a transition between the Ansetz tone 2, 3 and the fittings 1 1, 12 is sealed liquid-tight.
  • Each Anöneil 2, 3 has a Abbrech Gran 20, 30, which can be canceled to provide access to the container 1.
  • the Abbrech Glan 20 can be canceled by the Anmaneil 2 to connect a conveyor 5 in the form of a syringe to the Anangeeil 2 and to promote liquid in the container 1 into it.
  • the break-off piece 30 can be broken off from the attachment part 3, in order, e.g. pierce an infusion set with a piercing spike through the sealing element 6 and to take over liquid from the container 1, for example, to supply the liquid to a patient.
  • Each Anmaneil 2, 3 also has a connecting portion 21, 31, which can be brought into engagement with the associated connector 1 1, 12, in this way the respective Ansetz Division 2, 3 form-fitting manner with the associated connector 2, 3 to connect.
  • connection piece 1 1 An embodiment of a connector 1 1 and a Anmmeil 2 comprehensive connector show Fig. 3 to 1 1st
  • the connector 1 1 is here, as described above, to be connected with films of the container 1 and is thus absorbed in a material-locking manner between the films.
  • the Anmmeil 2 can be recognized, so that in the attached position, the Anmmeil 2 is held positively on the connecting piece 1 1.
  • the attachment piece 2 has a first portion, consisting of a connecting portion 21 and an adjoining threaded portion 22, and a Abbrech mosaic 20.
  • the Ansetz beautifully 2 is integrally molded as a plastic molding and is in an initial state with the associated with the threaded portion 22 Abbrech Gla 20 before.
  • the connector 1 1 has a flow opening 1 1 1, which is closed at attached to the connector 1 1 Anmaneil 2 by the Anmaneil 2 to the outside, so that no liquid from the container 1 out or into the container 1 can get into it. When attached Anmaneil 2 engages here, as can be seen from the sectional view of FIG.
  • the connector 1 1 with a head 1 10 in an opening 210 of the connecting portion 21 is about a circumferential positive locking element in the form of an annular projection 1 15 axially and via positive locking elements 1 16, 1 17 in the form of axially extending webs and grooves rotatably connected to the Anmineeil 2.
  • the sealing element 4 When attached to the connector 1 1 Anmineeil 2, the sealing element 4 comes to rest between the Anmineeil 2 and the connector 1 1 and is clamped between the Anöneil 2 and the connector 1 1 held.
  • the sealing element 4 can be inserted in an insertion direction E into the opening 210 within the attachment part 2 (see FIG. 6).
  • the sealing element 4 is, as shown in Fig. 7, formed as a rotationally symmetrical body and has a sealing head 40, which comes to rest in an engagement opening 221 of the threaded portion 22 and with a convex or planar side 400 on the threaded portion 22 also in the direction of Abrag Glas 20 protrudes.
  • the side 400 may also be substantially flush with the top of the threaded portion 22.
  • the sealing head 40 is adjoined by a cylindrical section 41, which merges into a shoulder 410 which, when the sealing element 4 is inserted into the opening 210, bears against a circumferential, conical contact surface 212 at the inner transition between the connecting section 21 and the threaded section 22 of the attachment part 2.
  • the cylindrical portion 41 here has a larger diameter than the sealing head 40.
  • At the shoulder 410 which projects radially beyond the portion 41 to the outside and rotates about the sealing element 4, includes a cylindrical body 42, with play in the opening 210th of the connecting portion 21 rests.
  • the cylindrical body 42 here has a smaller diameter than the shoulder 410.
  • this body 42 rests in the opening 210 at a radial distance from the circumferential wall of the connecting section 21, the sealing element 4 can be advantageously deformed when a conveyor 5 is attached, to create a flow through the sealing element 4 between the conveyor 5 and the container 1.
  • end of the body 42 carries a circumferential flange 420.
  • the flange 420 is located with its bottom 422 on a support surface 1 14 of the connector 1 1 on. Its top 421 can be completely exposed.
  • the top 421 is not covered in this case. It is not in abutment or in engagement with a corresponding component.
  • the top 421 is not covered with a clamping surface of the fitting 2.
  • the upper side 421 of the flange 420 can also be exposed only in sections.
  • the flange 420 may come in this configuration when attached to the connector 1 1
  • Anesthesia 2 sections between an annular projection 21 1 of the connecting portion 21 and a support surface 1 14 on the head 1 10 of the connector 1 1 come to rest and thus partially clamping between the annular projection 21 first and the support surface 1 14 are held.
  • the cylindrical body 42 has a recess 423 in its outside.
  • the recess 423 is provided by a step in the outside. In cross-section, the recess 423 has a substantially straight Ground.
  • the recess 423 has a cuboid cross-section.
  • the bottom and the radial opening of the recess 423 can hereby (seen in the insertion direction E) have substantially the same dimensions.
  • To the flange 420 includes a foot portion 43, which engages in a recess 1 13 on the head 1 10 of the connector 1 1.
  • the Anmaneil 2 is the front side on an outer flange 1 12 of the connector 1 1.
  • the sealing element 4 is supported with the shoulder 410 on the one hand on Anmaneil 2 and its flange 420 and the foot portion 1 13 on the other hand on the connector 1 1, a defined, secured position of the sealing element 4 is ensured within the opening 210 of the Anmaneils 2.
  • a cylindrical inner opening 44 which extends through the body 42 and the cylindrical portion 41 of the sealing element 4 from the foot portion 43 to the sealing head 40 and is in fluid communication with a tapered flow portion 1 18 of the connector 1 1 1, can at At the Anöneil 2 attached conveyor 5, a high flow between the conveyor 5 and the container 1 can be achieved.
  • the inner opening 44 has a diameter in a range of 1 mm to 5 mm, preferably 2 mm to 4 mm.
  • the Abbrech Industries 20 is connected via a predetermined breaking point 200 in the form of a notched, circumferential recess with the threaded portion 22.
  • a user can break off the break-off piece 20 from the threaded portion 22 by providing a grip element 201 of the Abbrech matterss 20 engages with his fingers and the Abbrech Sea 20 of the threaded portion 22 dissolves, as shown in Fig. 9. With removed Abbrech Sea 20 is the Anmaneil 2 thus without Abbrech fabrics 20 before, as shown in Fig. 10.
  • the sealing element 4 After canceling the Abbrech Partnerss 20, the sealing element 4 is exposed with its outwardly facing, for example, convex or planar side 400 on the sealing head 40 so that this outwardly facing side 400 can be accessed from the outside.
  • the sealing element 4 can be wiped or dabbed on this side 400 in a favorable manner to the sealing element 4 - accordingly any existing legal requirements - to clean and disinfect. Even a flat side 400 can be wiped off or dabbed accordingly.
  • a conveyor 5 in the form of a syringe can be attached to the threaded portion 22 by screwing a connecting element 50 in the form of a nut or nut of the conveyor 5 via threads 500 with threads 220 on the threaded portion 22 in Intervention is brought.
  • a connecting piece 51 of the conveyor 5 is inserted into the engagement opening 221 on the threaded portion 22, so that the connecting piece 51 presses on the sealing head 40 of the sealing element 4, this first presses down and then at the slot opening 45 (see Fig.
  • the connecting piece 51 thus penetrates the sealing head 40 at the slot opening 45 and comes into fluid communication with the cylindrical opening 44, so that a flow between the conveyor 5 and the flow opening 1 1 1 of the connecting piece 1 1 is provided.
  • the connecting piece 51 engages positively in the engagement opening 221 and passes through the sealing head 40, wherein a favorable flow connection between the connecting piece 51 and the flow opening 1 18 at the head 1 10 of the connector 1 1 is created, not or only insignificantly is impaired by the sealing element 4.
  • the conveyor 5 extends at the latest in fully scheduled, here, for example screwed, state with its connection piece 51 through the slot opening 45 of the sealing element 4, so that a flow between the conveyor 5 and the container 1 without hindrance or substantially unhindered by the sealing element 4 can.
  • the conveying device 5 has a syringe body 52 and a plunger 53 which can be pushed into the syringe body 52 in order in this way to convey a liquid from the syringe body 52 into the container 1.
  • the sealing head 40 of the sealing element 4 a for example, cross-shaped or straight, slot opening 45 is provided, a needle-free access is provided, which can be accessed using a conveyor 5 without injection needle.
  • the connecting piece 51 engages with the slot opening 45 and opens in this way the sealing element 4, so that a flow between the conveyor 5 and the container 1 is created.
  • the sealing element 4 closes automatically and self-sealing again, so that no liquid can get out of the container 1.
  • FIGS. 13 and 14 show a further embodiment in which a connection assembly consisting of a connection piece 1 1, an attachment part 2 arranged thereon and a sealing element 4 is used.
  • connection module is part of a connector 7 in the form of a so-called Y-connector.
  • the connector 7 has two line connections 70, 71, to each of which a medical line in the form of an infusion tube or the like can be connected.
  • the line connections 70, 71 are in flow connection with the connection piece 1 1 at a connection point 72, so that via the connection piece 1 1 a medical fluid can be introduced into a line system connected to the line connections 70, 71 or removed from the line system ,
  • a Anmaneil 2 is arranged in this embodiment. Between the Anmaneil 2 and the connecting piece 1 1, a sealing element 4 is clamped.
  • a break-off piece 20 is connected to the threaded portion 22 of the attachment part 2, which can be broken off to connect a conveyor 5 (see FIG. 12) to the threaded portion 22 and the conveyor 5 above the Connection piece 1 1 to connect.
  • the sealing element 4 with a convex side 400 on the top 222 of the threaded portion 22 can protrude outwardly and thus easily accessible from the outside, the sealing element 4 can be wiped at its side 400 before connecting the conveyor 5 in a comfortable manner to disinfect the sealing element 4 on its outwardly facing side 400. Even a flat side 400 can be wiped off or dabbed accordingly.

Landscapes

  • Health & Medical Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Fluid Mechanics (AREA)
  • Physics & Mathematics (AREA)
  • Hematology (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Quick-Acting Or Multi-Walled Pipe Joints (AREA)

Abstract

La présente invention concerne un module de raccordement pour conduire un fluide médical comprenant une pièce de raccordement (11) permettant de transporter un fluide médical, une partie accessoire (2) pouvant être placée sur la pièce de raccordement (11), raccordée à un système de transport (5) pour le transport d'un fluide médical à travers la pièce de raccordement et présentant une ouverture (210) dans laquelle vient en prise la pièce de raccordement (11) lorsque la partie accessoire (2) est placée sur la pièce de raccordement (11), et un élément d'étanchéité (4) pour rendre étanche une transition entre la pièce de raccordement (11, 12) et la partie accessoire (2), l'élément d'étanchéité (4) pouvant être inséré dans un sens d'insertion (E) dans l'ouverture (210) de la partie accessoire (2) de telle sorte que, lorsque la partie accessoire (2) est placée sur la pièce de raccordement (11), l'élément d'étanchéité (4) soit maintenu entre la pièce accessoire (2) et la pièce de raccordement (11). L'élément d'étanchéité (4) présente une tête d'étanchéité (40) qui ferme l'ouverture (210) de la partie accessoire (2) vis-à-vis de la pénétration du fluide lorsque la partie accessoire (2) est placée sur la pièce de raccordement (11), et un corps (42) rattaché à la tête d'étanchéité (40) et pouvant être disposé dans l'ouverture (210) à une certaine distance radiale de la partie accessoire (2). Une chambre intérieure de l'élément d'étanchéité (4) est dépourvu d'un corps ayant une pointe, qui doit favoriser l'ouverture de la tête d'étanchéité (40). Selon l'invention, l'élément d'étanchéité (4) placé au niveau de la transition entre la tête d'étanchéité (40) et le corps (42) présente un épaulement (410) faisant saillie de la tête d'étanchéité (40) radialement par rapport au sens d'insertion (E), qui peut venir en appui avec une surface d'appui (212) associée le long du sens d'insertion (E) à l'intérieur de l'ouverture (210) de la partie accessoire (2), et une bride (420) faisant saillie radialement vers l'extérieur, située à une certaine distance de l'épaulement (410) le long du sens d'insertion (E) par rapport au corps (42) de l'élément d'étanchéité (4), qui est maintenue entre la partie accessoire (2) et la pièce de raccordement (11) lorsque la partie accessoire (2) est placée sur la pièce de raccordement (11) de telle sorte que la bride (420) repose avec sa face inférieure (422) sur une surface d'appui (114) de la pièce de raccordement (11) et que sa face supérieure (421) soit au moins partiellement libre, et une section de pied (43) qui vient en prise dans une cavité associée (113) dans la pièce de raccordement (11) lorsque la partie accessoire (2) est placée sur la pièce de raccordement (11). L'invention permet ainsi de mettre à disposition un module de raccordement pour la conduite d'un fluide médical qui permet un maintien fiable de l'élément d'étanchéité entre la pièce de raccordement et la partie accessoire.
EP16727339.0A 2015-05-22 2016-05-23 Module de raccordement pour conduire un fluide médical Pending EP3297596A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP15168952 2015-05-22
PCT/EP2016/061582 WO2016188957A1 (fr) 2015-05-22 2016-05-23 Module de raccordement pour conduire un fluide médical

Publications (1)

Publication Number Publication Date
EP3297596A1 true EP3297596A1 (fr) 2018-03-28

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US (3) US11234898B2 (fr)
EP (1) EP3297596A1 (fr)
JP (3) JP2018515266A (fr)
KR (1) KR102593070B1 (fr)
CN (1) CN107645948B (fr)
AU (1) AU2016266694B2 (fr)
BR (1) BR112017022203B1 (fr)
CA (1) CA2986496C (fr)
CL (1) CL2017002968A1 (fr)
HK (1) HK1247551A1 (fr)
MX (1) MX2017014876A (fr)
WO (1) WO2016188957A1 (fr)
ZA (1) ZA201707390B (fr)

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WO2016188957A1 (fr) 2015-05-22 2016-12-01 Fresenius Kabi Deutschland Gmbh Module de raccordement pour conduire un fluide médical
US11883364B2 (en) 2015-05-22 2024-01-30 Fresenius Kabi Deutschland Gmbh Connection assembly for directing a medical liquid
EP3810254B1 (fr) * 2018-06-20 2024-02-21 Fresenius Kabi Deutschland GmbH Ensemble raccord destiné à raccorder des tuyaux médicaux comprenant un élément de recouvrement
CA3128837A1 (fr) * 2019-03-08 2020-09-17 Torsten Brandenburger Ensemble de raccordement pour diriger un liquide medical
EP4076334A1 (fr) 2019-12-17 2022-10-26 Fresenius Kabi Deutschland GmbH Raccord et système de raccordement pour un emballage médical et procédé de fourniture d'un liquide pour un emballage médical
USD983407S1 (en) * 2020-10-20 2023-04-11 Verrica Pharmaceuticals Inc. Ampule crush tool

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KR20180011098A (ko) 2018-01-31
US11291608B2 (en) 2022-04-05
US20180092807A1 (en) 2018-04-05
WO2016188957A1 (fr) 2016-12-01
US20180271748A1 (en) 2018-09-27
US10576019B2 (en) 2020-03-03
CN107645948A (zh) 2018-01-30
CA2986496A1 (fr) 2016-12-01
BR112017022203B1 (pt) 2022-04-05
ZA201707390B (en) 2019-01-30
KR102593070B1 (ko) 2023-10-23
AU2016266694B2 (en) 2020-07-09
MX2017014876A (es) 2018-04-20
JP2018515266A (ja) 2018-06-14
HK1247551A1 (zh) 2018-09-28
AU2016266694A1 (en) 2017-11-02
CN107645948B (zh) 2021-10-29
JP7504037B2 (ja) 2024-06-21
JP2023156446A (ja) 2023-10-24
US11234898B2 (en) 2022-02-01
CL2017002968A1 (es) 2018-06-08
JP2021072934A (ja) 2021-05-13
BR112017022203A2 (pt) 2018-07-03
CA2986496C (fr) 2024-06-11
US20180153770A1 (en) 2018-06-07

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