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EP3233016B1 - Système de connecteur ayant au moins deux ports de prélèvement - Google Patents

Système de connecteur ayant au moins deux ports de prélèvement Download PDF

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Publication number
EP3233016B1
EP3233016B1 EP15813445.2A EP15813445A EP3233016B1 EP 3233016 B1 EP3233016 B1 EP 3233016B1 EP 15813445 A EP15813445 A EP 15813445A EP 3233016 B1 EP3233016 B1 EP 3233016B1
Authority
EP
European Patent Office
Prior art keywords
withdrawal port
port
connector system
withdrawal
membrane
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.)
Active
Application number
EP15813445.2A
Other languages
German (de)
English (en)
Other versions
EP3233016A1 (fr
Inventor
Torsten Brandenburger
Ismael Rahimy
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
Priority to PL15813445T priority Critical patent/PL3233016T3/pl
Publication of EP3233016A1 publication Critical patent/EP3233016A1/fr
Application granted granted Critical
Publication of EP3233016B1 publication Critical patent/EP3233016B1/fr
Active legal-status Critical Current
Anticipated expiration legal-status Critical

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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
    • A61J1/1475—Inlet or outlet ports
    • A61J1/1487—Inlet or outlet ports with friction fit, e.g. connecting tubes directly to a protruding port
    • 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
    • A61J1/1412—Containers with closing means, e.g. caps
    • 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
    • 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
    • A61J2205/00—General identification or selection means
    • A61J2205/50—General identification or selection means using icons or symbolic figures, e.g. by a graphical representation symbolising the type of pathology or the organ by an image

Definitions

  • the invention relates to a connector system for connecting a removal device to a container for a medical fluid according to the preamble of claim 1 and a container for a medical fluid with such a connector system according to the preamble of claim 14.
  • the invention is based on the problem to provide a connector system of the type mentioned above and a container for a medical fluid, which are versatile.
  • the connector system for connecting one or at least a removal device, preferably of two removal devices, to a container for a medical liquid, in particular for a medical rinse solution.
  • the connector system comprises a first removal port and a second removal port, which are respectively designed for a removal of the medical fluid from the container:
  • the first removal port and the second removal port are each closed with a resealable membrane and a breakable cap as tamper-evident.
  • the first removal port and the second removal port are formed differently. This has the advantage that the user no longer needs to retrofit the removal port in order to use it with the disposal devices available to him. It is also no longer necessary to keep rinsing solution containers available with different removal ports.
  • the ports can be provided in a sterile condition.
  • a connector system of the aforementioned type when used as intended, includes a container containing a medical fluid, in particular a sterile container, and makes it possible to establish a fluid connection between the container containing the medical fluid and a removal device.
  • a medical connector system for the preparation of the fluid connection, that is to be able to remove medical liquid from the container, the first removal port and the second removal port are provided according to the invention.
  • the connector system can be suitable as a medical connector system, in particular for the sterile connection of an infusion and dialysis bag or a rinsing solution bag as a container on the one hand and a transfer device or other medical assemblies as a removal device on the other.
  • first removal port and the second removal port can be designed differently in such a way that they can receive a removal device with respectively different flow rates and / or different connections.
  • the first removal port and / or the first removal device are preferably designed such that a larger flow rate than the second removal port and / or the second removal device can be provided.
  • the first removal device and the second removal device can also be connected to the container at the same time.
  • the first removal port is designed to receive a first removal device with a cylinder connection and / or the second removal port is designed to receive a second removal device a spike connection.
  • the first and / or the second removal device may comprise a drip chamber and / or a hose of a transfer system.
  • the cylinder connection of the first removal device can also be referred to as a pipe connection.
  • the cylinder attachment system is preferably threaded to prevent inadvertent release from the connector system.
  • the cylinder connection comprises at least one substantially cylindrical pipe section, which can be inserted into the first removal port.
  • the cylinder port opens the diaphragm.
  • the cylinder port has no tip.
  • the end faces of the cylinder connection, which press against the membrane, are arranged substantially transversely, preferably perpendicular to the longitudinal axis of the cylinder connection. The faces may have a finish to aid in opening the membrane.
  • the front portion of the cylinder connection in particular in addition, be at least partially conical.
  • the cylinder connection as such does not have an oblique cut.
  • the cylinder port is a Care-Lock type port.
  • the first removal port has an external thread. By screwing on the cylinder connection of the first removal device, it can be connected to the first removal port and a fluid connection can be established by opening the membrane.
  • the second removal port can be connected to the membrane of the second removal port by piercing the spike connection of the second removal device and a fluid connection can be established by opening the membrane.
  • the first removal port and the second removal port of the connector system usually each have a channel for establishing a fluid connection between the container and the removal device.
  • the channel of the second sampling port may have a larger inner diameter in sections than the channel of the first sampling port in order to provide a different flow rate compared to the first sampling port can.
  • the channel of the first sampling port may be longer than the channel of the second sampling port.
  • the channel of the second sampling port has a cross-section tapering in the direction of the container.
  • the channel of the second sampling port is dimensioned in its length so that the piercing spike of the second sampling device in the fully inserted state at least over half of Length of the channel extends. As a result, the second removal device can be securely held in the second removal port.
  • a, preferably transparent, protective cap is arranged on the first removal port.
  • the protective cap has an internal thread and is releasably secured to the external thread of the first removal port, in particular in the original state, screwed or screwed.
  • the breakaway cap is effectively protected against inadvertent breakage, dust and contamination. If the protective cap is transparent, the originality of this port can be checked visually through the protective cap.
  • the break-off caps of the first and / or the second removal port are each formed in a variant as flat handles. You can only cover the flat handles.
  • the rupturable caps are mounted without touching the puncture sites.
  • the breakable caps of the first and second sampling ports each have an arrow identifying the first and second sampling ports as a sampling port for removing a liquid.
  • the breakaway cap of the first extraction port is higher than the breakaway cap of the second extraction port and / or the breakaway cap of the second extraction port is wider than the breakaway cap of the first extraction port.
  • the first removal port and the second removal port each have a membrane, which is also referred to below as a sealing element on. This extends over the entire cross section of the respective channel to seal the container.
  • the first removal port and the second removal port each have a lower part and an upper part seated on the lower part, wherein the upper part and the lower part are formed as snap-on juxtaposed connecting pieces, whereby the assembly of the connector system can be simplified.
  • a snap connection is reproducible. In particular, by the snap connection and a possible, for example in the ultrasonic welding process occurring, particle formation can be avoided or at least reduced.
  • the sealing element can be clamped between the upper part and the lower part.
  • the sealing element is elastic and resealable.
  • the sealing element of the first sampling port may preferably be made of a thermoplastic elastomer. But it can also be made of polyisoprene, silicone or chlorobuthyl.
  • the sealing element of the second removal port may preferably be made of polyisoprene.
  • the sealing element of the first sampling port may comprise a, preferably continuous, slit valve.
  • the membrane of the second sampling port may include a slit valve, preferably punched or continuous.
  • a region of the upper part and a region of the lower part may be provided, which for preventing rotation of the upper part and of the lower part to cooperate.
  • the sealing element of the second extraction port which is designed in particular for smaller flow rates, may have a central reinforcement region with a material thickness which is higher than the material thickness of a region directly surrounding the central reinforcement region.
  • the second removal device can be kept stable with the mandrel connection by the sealing element itself when the mandrel connection of the second removal device penetrates the sealing element.
  • the sealing element of the first extraction port is formed in the region which lies in the channel of the first extraction port, as a substantially flat disc.
  • a double holding device may be provided on the upper part of the second removal port.
  • a ring and a ring concentrically surrounding the projection may be formed on the upper part, which extend from the upper part in the direction of the lower part and thereby at the intended Arrangement of the sealing element abut the sealing element to prevent slipping of the sealing element in the removal port.
  • the first removal port can have, for example on the upper part, an external thread via which the removal device can be detachably connected to the first removal port.
  • the material of the first sampling port and / or the second sampling port may be or include polypropylene.
  • the protective cap of the first sampling port may be made of polypropylene or include this.
  • the connector system has more than two sampling ports, which are each formed differently.
  • the medical fluid is preferably a rinsing fluid.
  • the medical fluid is preferably a rinsing fluid.
  • This can be used, for example, in the diagnosis and / or in surgical interventions, for example in urology, cystoscopy and / or arthroscopy.
  • the first extraction port is used in arthroscopy.
  • the second withdrawal port is preferably used in urology.
  • the container is preferably a bag, which in particular has a capacity of greater than 1000 ml.
  • a system comprising an embodiment of the connector system according to the invention, in particular comprising a bag with a connector system according to the invention attached to the bag, and a first removal device with a cylinder connection and / or a second removal device with a mandrel connection.
  • a first removal port 2 and a second removal port 4 are shown, which together form a connector system.
  • the first removal port 2 and the second removal port 4 each comprise a carrier 6, which is designed in the form of a shuttle and serves to fasten the removal ports 2, 4 to the container.
  • the Schiffchen 6 comprises, viewed in the flow direction S, two convex outer walls, which converge at their ends in each case at an acute angle.
  • the convex outer walls may have a groove-like surface structure, whereby the strength of the connection of the shuttle 6 with the container by increasing the surface of the outer walls is increased (see also the Figures 4.a, 4.b and 5.a ).
  • the container is for example a bag made of a plastic with a material layer or two, three or more layers of material.
  • the shuttles 6 can be welded to the container in an edge region between the material layers for fastening the first removal port 2 and the second removal port 4.
  • a first removal device 60 with a cylinder port 61 sealingly connected (see the Figures 5.a to 5.c Left).
  • a second removal device 70 with a mandrel connection 71 is sealingly connectable (see the Figures 5.a to 5.c right).
  • the first removal port 2 comprises an upper part 8, which sits on a lower part 10.
  • the upper part 8 has an upper, the lower part 10 facing away, section 8a and a lower, the lower part 10 facing portion 8b.
  • the upper section 8a serves to receive a removal device 60, for example a hose line, with a cylinder connection 61.
  • the lower part 10 has an upper section 8a facing the upper part 8 and a lower section 10b facing away from the upper part 8b.
  • the lower portion 8b of the upper part 8 and the upper portion 10a of the lower part 10 are formed as snap-on juxtaposed connecting pieces, which connect the upper part 8 and the lower part 10 in the intended arranged state.
  • the lower portion 10b of the lower part 10 carries the boat 6, via which the first removal port 2 is connectable to the container.
  • the lower part 10 has a in a plane transverse to the flow direction S, the lower part 10 in the circumferential direction on the outside of the lower part 10 circumferential projection 12 and the upper part 8 a corresponding, on the inside of the upper part 8 provided groove 14 for receiving the projection 12.
  • the protrusion 12 may be formed on the inside of the top 8 and the groove 14 on the outside of the bottom 10.
  • the upper part 8 surrounds the lower part 10 in sections, so that the upper part 8 forms a female connector element and the lower part 10 forms a male connector element.
  • the connecting pieces may be formed so that the lower part 10 in sections the Upper part 8 surrounds (the upper part 8 is thus a male connector element and the lower part 10 is a female connector element).
  • the upper part 8 is thus a male connector element and the lower part 10 is a female connector element.
  • a projection or a groove and on the inside of the lower part 10 complementary a groove or a projection is formed.
  • Another embodiment would be a connection by means of welding.
  • the lower part 10 In order to avoid that at very high force when connecting the upper part 8 with the lower part 10, the groove 14 is moved beyond the projection 12, the lower part 10 has a stop 16 which blocks the movement of the upper part 8 as soon as the Lower part 10 facing the end of the upper part 8 rests against the stop 16 in the intended condition.
  • This also has the advantage that a sealing element 20 described below, which is intended to be arranged between the upper part 8 and the lower part 10, can not be damaged during assembly of the upper part 8 and the lower part 10.
  • the upper part 8 and the lower part 10 are each formed as a hollow body with a channel 18 a, 18 b.
  • the channel 18a of the upper part 8 and the channel 18b of the lower part 10 form a channel 18 which extends along the flow direction S.
  • a sealing element 20 is arranged, which can be opened, for example, for the purpose of establishing a fluid connection between a container on which the first removal port 2 can be fastened, and of the cylinder port 61 of the second removal device 60.
  • the sealing element 20 rests on the upper part 8 facing the lower part 10.
  • the sealing element 20 is designed as an elastic, resealable membrane 20.
  • the membrane 20 is made of a thermoplastic elastomer. But it can also be made of polyisoprene, silicone or chlorobuthyl.
  • the membrane 20 extends over the entire cross section of the lower part 10 at its end facing the upper part to seal the first removal port 2 and thus the container.
  • the membrane 20 comprises a preferably continuous, slit valve 22 to facilitate or at least facilitate the insertion of the cylinder port 61 of the sampling device 60 and the establishment of a fluid connection.
  • the membrane 20 is particularly suitable for the use of Care-Lock type removal devices.
  • the membrane 20 In order to allow a precise positioning of the membrane 20 on the lower part 10 and thus to achieve the desired sealing effect of the membrane 20, the membrane 20 on its side facing the lower part 10 along its peripheral edge on a counter to the flow direction S outstanding collar 24b.
  • the lower part 10 For placing this collar 24b on the lower part 10, the lower part 10 has a corresponding receiving region 26b for the collar 24b.
  • the receiving region 26b is concretely formed by a section-wise reduction of the outer diameter of the lower part 10 at its end facing the upper part 8.
  • the membrane 20 has a collar 24a projecting along the flow direction S along its peripheral edge.
  • the upper part 8 has a receiving region 26a for the membrane 20.
  • the inner diameter of the upper part 8 is smaller compared to the inner diameter of the receiving portion 26a of the upper part 8, whereby a stop 28 on the lower part 10 facing away from the end of the receiving region 26a is formed, on which the collar 24a of the membrane 20 rests in the intended arranged state.
  • annular projection 30 projects axially from the stop 28 in the direction of the lower part 10 into the receiving region 26a, wherein the projection 30 is arranged at a distance from the peripheral wall of the upper part 8 delimiting the receiving region 26a.
  • the collar 24a is arranged radially between the projection 30 and the peripheral wall.
  • the annular projection 30 and the collar 24a are dimensioned such that the collar 24a bears against the projection 30 and against the peripheral wall of the upper part 8 delimiting the receiving region 26a.
  • the membrane 20 In the connected state, the membrane 20 is held radially by their placement in the receiving areas 26a, 26b, so that, for example, when inserting a cylinder connection in or against the membrane 20 slipping of the membrane is avoided.
  • the upper part 8 is closed at its end facing away from the lower part 10 for the protection of the membrane 20 with a breakable cap 32. Furthermore, the breakable cap 32 as a tamper evident closure. In order to facilitate the breaking off of the cap 32, a circumferential predetermined breaking point 34 is formed between the cap 32 and the end of the upper part 8 facing away from the lower part 10. Further, a handle 36 is provided on the cap 32 to grip the cap 32 for breaking.
  • the break-off cap 32 In order to prevent the break-off cap 32 accidentally breaks off, for example, during transport of the first removal port 2, the break-off cap 32 is surrounded by a protective cap 38 which is secured via a screw connection to the upper portion 8a of the upper part 8.
  • a thread 40a is provided on the outside of the upper section 8a of the upper part 8, and a thread 40b is provided on the inside of the protective cap 38.
  • the thread 40a of the upper part 8 also serves to additionally secure a removal device 60, which comprises a union nut with an internal thread 61-3, to the upper part 8, in order to prevent accidental slipping out of the removal device 60 from the membrane 20 (see in this regard FIG Figures 5.a to 5.c ).
  • an anti-twist device is provided.
  • the rotation is formed by elements that are different from the elements for producing the snap connection between the upper part 8 and the lower part 10.
  • a tooth profile 42a and formed on the outside of the lower part 10 a tooth profile 42b, wherein the teeth of the tooth profiles 42a, 42b extend axially along the flow direction S.
  • the tooth profile 42b of the lower part 10 below the receiving portion 26b for the collar 24b of the membrane 20 is arranged.
  • the teeth of the two tooth profiles 42a, 42b engage each other. Accordingly, the tooth profile 42a of the upper part 8 is provided at a height corresponding to the height of the tooth profile 42b of the lower part 10 in the connected state.
  • other means for preventing rotation such as a pin and a corresponding receptacle or an axial web or a plurality of axial webs on the lower part 10 and, accordingly, a groove or a plurality of grooves in the upper part 8, which extend along the flow direction S, conceivable.
  • the channel 18 has a length l of 5 to 8 cm, preferably 6 to 7 cm, particularly preferably 6.5 cm.
  • the specified length l corresponds to the length Removing the breakaway cap 32.
  • the portion of the top 8, which is located between the bottom of the upper part 8 facing away from the upper part 8 (after removing the breakable cap 32) and the receiving portion 26 a, has a length l 1 of 0.8 to 1.6 cm, preferably from 1.0 to 1.4 cm, more preferably from 1.2 cm. This section substantially corresponds to the upper portion 8a of the upper part 8, which serves to receive a removal device.
  • the channel 18b of the lower part 10 is slightly conical, so that the inner diameter of the channel 18b of the lower part 10 varies over the length of the channel 18b.
  • the inner diameter of the channel 18b at its end facing the upper part 8 is 5 to 8 mm, preferably 6 to 7 mm, particularly preferably 6.5 mm.
  • the inner diameter of the channel 18b at its end facing away from the upper part 8 is 2 to 6 mm, preferably 3 to 5 mm, particularly preferably 4 mm.
  • the inner diameter of the channel 18a of the upper part 8 at its end facing away from the lower part 10 is 4 to 8 mm, preferably 5 to 7 mm, particularly preferably 6 mm.
  • the second removal port 4 ( FIG. 2 ) is similar in structure to the first withdrawal port 2. Therefore, like reference numerals are used in the figures for the same elements. In the description of the second sampling port 4, particular attention is paid to the differences with respect to the first sampling port 2. It is understood that the description of the first sampling port 2, with the exception of the differences explained below, also applies to the second sampling port 4.
  • the second removal port 4 differs from the first removal port 2 in that a second removal device 70 can be connected to a mandrel connection 71. It therefore differs in particular also by its dimensions.
  • the channel 18 of the second sampling port 4 has a length I of 3.5 to 6.5 cm, preferably 4.5 to 5.5 cm, particularly preferably 5 cm.
  • the specified length I corresponds to the lengthwise removal of the breakaway cap 33.
  • the breakable cap 33 of the second removal port 4 has here a greater width and a smaller height than the breakable cap 32 of the first removal port 2.
  • the breakable cap 33 here comprises a flat handle 37.
  • the portion of the upper part 8, which is located between the lower part 10 opposite end of the upper part 8 (after removal of the breakable cap 33) and the receiving portion 26 a, has a length l 1 of 2 to 5 mm, preferably from 3 to 4 mm , This section corresponds to Essentially the upper portion 8a of the upper part 8, which serves to receive a removal device.
  • the channel 18 b of the lower part 10 is slightly conical, so that the inner diameter of the channel 18 b varies over the length of the lower part 10.
  • the inner diameter of the channel 18b at the end facing away from the upper part 8 is 2 to 6 mm, preferably 3 to 5 mm, particularly preferably 4 mm.
  • the inner diameter of the channel 18a of the upper part 8 at the end remote from the lower part 10 is 4 to 8 mm, preferably 5 to 7 mm, particularly preferably 6 mm.
  • the membrane 21 of the second removal port 4 is made of polyisoprene.
  • the membrane 21 of the second sampling port 4 preferably no slit valve is formed. This membrane 21 can be pierced by the pointed mandrel connection and opened with it. In order to simplify the opening, but also here, preferably continuous or punched, slit valve may be formed.
  • the membrane 21 of the second removal port 4 has, in addition to the upper part 8 facing collar 24a and the lower part 10 facing collar 24b a central reinforcement region 44 which is provided in the intended condition on the upper part 8 facing side of the membrane 21.
  • the central reinforcement portion 44 is located in a region bounded by the collar 24a, the collar 24a being spaced from the central reinforcement portion 44 by an annular gap 46.
  • the central reinforcement region 44 has a height (material thickness along the flow direction S, starting from the side of the membrane 21 facing the upper part 8) which essentially corresponds to the height of the collar 24a.
  • reclosing of the membrane 21 after the removal of the mandrel connection 71 can also be supported.
  • a receiving area 26a in the upper part 8 and a receiving area 26b in the lower part 10 are provided as in the first removal port 2.
  • a ring 48 extending concentrically with the projection 30 protrudes into the receiving region 26a in addition to the projection 30.
  • the ring 48 extends from the end remote from the lower part 10 of the upper part 8 within a limited area of the projection 30 and ends substantially at the same height as the lower part 10 facing the end of the projection 30.
  • the ring 48 is provided with a axial end fixed to the lower part 10 facing away from the end of the upper part 8 and thus formed to spring in the radial direction.
  • Both the projection 30 and the ring 48 are in the intended condition of the membrane 21 in the annular gap 46 of the membrane 20 on the upper part 8 facing side of the membrane 20 at.
  • the second removal port 4 has no additional protective cap to protect the break-off cap 33.
  • FIG 3.a a further embodiment of the connector system is shown, in which the first extraction port 2 off FIG. 1 and the second removal port 4 off FIG. 2 are formed on a common boat 6.
  • the connector system is welded or welded to a container to seal the container.
  • Figure 3.b is such a container 50 in the form of a foil bag with the connector system Figure 3.a shown.
  • the foil bag 50 is formed, for example, from a plurality of material layers 52, which are connected to each other at their edges by a peripheral weld 54.
  • the connector system in particular the shuttle 6 of the connector system, is arranged between the material layers 52 in the region of the weld seam 54 and sealingly welded to the two material layers 52.
  • the weld 54 and the connector system thus close an interior space of the container, in which, for example, a medical fluid is stored, from the environment.
  • a removal device 60 or 70 can be inserted into one of the two removal ports 2, 4.
  • the first and second removal devices 60 and 70 can also be introduced simultaneously or together into the respective removal port 2, 4.
  • Figure 4.a shows a side view of the connector system of the Figures 3.a and 3.b
  • the Figure 4.b shows the (reversed) representation Figure 4.a , In contrast to Figure 4.a
  • the first removal port 2 already the protective cap 38 is removed.
  • the second removal port 4 not yet the upper part 8 on the lower part 10th assembled.
  • the arrows 55, 56 on or in the breakaway caps 32 and 33 which identify the two sampling ports 2 and 4 as sampling ports.
  • the two arrows are here exemplified as openings in the two caps 32 and 33 introduced.
  • FIGs 5.a to 5.c illustrate the interaction of the connector system according to the invention with the removal devices 60 and 70.
  • the break off caps 32 and 33 are already removed.
  • the two removal devices here are the first removal device 60 with a cylinder connection 61 and the second removal device 70 with a mandrel connection 71
  • Figures 5.a and 5.b show the two removal devices 60 and 70 in the unconnected state.
  • the Figure 5.c shows the two sampling devices 60 and 70, however, in the intended connective state, here the fully connected state.
  • Figure 5.a shows the presentation Figure 4.b with the first removal device 60 and the second removal device 70.
  • the first removal device 60 is assigned to the first removal port 2.
  • the second removal device 70 is assigned to the second removal port 4.
  • the first removal device 60 here comprises an optional drip chamber 62 and a hose, not shown here.
  • it includes a cylinder port 61 for connection to the first removal port 2.
  • the second removal device 70 here also includes an optional drip chamber 72 and a hose, not shown here.
  • the break-off caps 32 and 33 are already removed from the two ports 2 and 4.
  • the mandrel connection 71 of the second removal device 70 may also be referred to as a piercing spike or spike. This is introduced into the second removal port 4, pierces the membrane 21 with its tip and thereby establishes a fluid connection.
  • the mandrel connection 71 is held in the inserted state, in particular by means of clamping through the membrane 21 and / or the channel 18 and / or through the channel section above the membrane in its position.
  • the channel 18 of the second sampling port 4 is here dimensioned in its length so that the piercing spike 71 extends in the fully inserted state at least over half the length of the channel 18. As a result, the second removal device 4 can be securely held in the second removal port 4.
  • the cylinder port 61 comprises the inner, substantially cylindrical pipe section 61-1, which is insertable into the first removal port 2. At the latest in the fully inserted state, the pipe section 61-1 opens the membrane 20.
  • the end faces of the pipe section 61-1, which press against the membrane 20, are here arranged essentially perpendicular to the longitudinal axis of the cylinder connection 61.
  • the end surfaces or the front portion of the pipe section 61-1 may have a finish and / or a cone as illustrated herein to assist in opening the membrane 20.
  • the cylinder port 61 is a Care-Lock type port.
  • the cylinder port 61 is formed in particular by two concentric pipe sections 61-1 and 61-2 of different lengths.
  • the outer tube portion 61-2 has a larger diameter and extends beyond the inner tube portion 61-1.
  • Both pipe sections 61-1 and 61-2 are made substantially cylindrical.
  • a thread 61-3 is arranged in the lower region which lies in the direction of the drip chamber.

Landscapes

  • Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Hematology (AREA)
  • Physics & Mathematics (AREA)
  • Fluid Mechanics (AREA)
  • Closures For Containers (AREA)
  • External Artificial Organs (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)

Claims (14)

  1. Système de connecteurs pour le raccordement d'un dispositif de prélèvement à un réservoir (50) pour un liquide médical, qui comprend un premier orifice de prélèvement (2) et un second orifice de prélèvement (4), qui sont respectivement configurés pour un prélèvement du liquide médical hors du réservoir (50), dans lequel le premier orifice de prélèvement (2) et le second orifice de prélèvement (4) sont configurés différemment et sont fermés respectivement avec une membrane refermable (20, 21) et un capuchon frangible (32, 33), dans lequel le premier orifice de prélèvement (2) est configuré pour accueillir un premier dispositif de prélèvement (60) avec un raccord cylindrique (61) et dans lequel le second orifice de prélèvement (4) est configuré pour accueillir un deuxième dispositif de prélèvement (70) avec un raccord à broche (71).
  2. Système de connecteurs selon la revendication 1, caractérisé en ce que le premier orifice de prélèvement (2) et le second orifice de prélèvement (4) sont configurés pour accueillir un dispositif de prélèvement (60, 70) avec des débits chaque fois différents et/ou des raccords (61, 71) chaque fois différents.
  3. Système de connecteurs selon l'une quelconque des revendications précédentes, caractérisé en ce que le premier orifice de prélèvement (2) présente un filet extérieur (40a) et peut être raccordé au premier dispositif de prélèvement (60) par un vissage du raccord cylindrique (61) de celui-ci et un raccordement fluidique peut être réalisé par une ouverture de la membrane (20) et/ou en ce que le second orifice de prélèvement (4) peut être raccordé au deuxième dispositif de prélèvement (70) par un enfoncement du raccord à broche (71) de celui-ci dans la membrane (21) du second orifice de prélèvement (4) et un raccordement fluidique peut être réalisé par une ouverture de la membrane (21).
  4. Système de connecteurs selon l'une quelconque des revendications précédentes, caractérisé en ce que le premier orifice de prélèvement (2) et le second orifice de prélèvement (4) présentent respectivement un canal (18) permettant de réaliser un raccordement fluidique entre le réservoir (50) et le dispositif de prélèvement respectif (60, 70), dans lequel le canal (18) du second orifice de prélèvement (4) présente sur certaines portions un plus grand diamètre intérieur que le canal (18) du premier orifice de prélèvement (2) et/ou en ce que le canal (18) du second orifice de prélèvement (4) est dimensionné en longueur de telle façon que la broche à enfoncer (71) s'étende, à l'état entièrement enfoncé, au moins sur la moitié de la longueur du canal (18) .
  5. Système de connecteurs selon l'une quelconque des revendications précédentes, caractérisé en ce que le canal (18) du premier orifice de prélèvement (2) est plus long que le canal (18) du second orifice de prélèvement (4) et/ou en ce que le canal (18) du second orifice de prélèvement (4) possède une section transversale s'amenuisant en direction du réservoir (52) .
  6. Système de connecteurs selon l'une quelconque des revendications précédentes, caractérisé en ce qu'un capuchon de protection (38), de préférence transparent, est disposé sur le premier orifice de prélèvement (2), lequel présente un filet intérieur (40b) et est vissé de façon fixe séparable sur le filet extérieur (40a) du premier orifice de prélèvement (2).
  7. Système de connecteurs selon l'une quelconque des revendications précédentes, caractérisé en ce que les capuchons frangibles (32, 33) du premier et/ou du second orifice de prélèvement (2, 4) sont chacun réalisés sous forme de poignée plate (36, 37).
  8. Système de connecteurs selon l'une quelconque des revendications précédentes, caractérisé en ce que les capuchons frangibles (32, 33) du premier et du second orifice de prélèvement (2, 4) présentent respectivement une flèche (55, 56), qui identifie le premier et le second orifice de prélèvement (2, 4) comme étant un orifice de prélèvement (2, 4) .
  9. Système de connecteurs selon l'une quelconque des revendications précédentes, caractérisé en ce que le capuchon frangible (32) du premier orifice de prélèvement (2) est plus haut que le capuchon frangible (33) du second orifice de prélèvement (4) et/ou en ce que le capuchon frangible (33) du second orifice de prélèvement (4) est plus large que le capuchon frangible (32) du premier orifice de prélèvement (2).
  10. Système de connecteurs selon l'une quelconque des revendications précédentes, caractérisé en ce que la membrane (20) du premier orifice de prélèvement (2) est réalisée, dans la région qui est située dans le canal (18) du premier orifice de prélèvement (2), sous forme de disque essentiellement plat et/ou en ce que la membrane (21) du second orifice de prélèvement (4) présente une zone de renforcement centrale (44) avec une épaisseur de matière, qui est plus grande que l'épaisseur de matière d'une zone (46) entourant directement la zone de renforcement centrale (44).
  11. Système de connecteurs selon l'une quelconque des revendications précédentes, caractérisé en ce que le premier orifice de prélèvement (2) et le second orifice de prélèvement (4) présentent respectivement une partie inférieure (10) et une partie supérieure (8) posée sur la partie inférieure (10), dans lequel la partie supérieure (8) et la partie inférieur (10) sont réalisées sous forme de pièces de connexion à déclic engagées l'une sur l'autre, en particulier dans lequel la membrane (20) du premier orifice de prélèvement (2) et la membrane (21) du second orifice de prélèvement (4) sont bloquées par serrage entre la partie inférieure respective (10) et la partie supérieure respective (8).
  12. Système de connecteurs selon l'une quelconque des revendications précédentes, caractérisé en ce qu'un anneau (48) et une saillie (30) entourant concentriquement l'anneau (48) sont formés sur la partie supérieure (8) du second orifice de prélèvement (4), lesquels s'étendent depuis la partie supérieure (8) en direction de la partie inférieure (10) et sont prévus pour le support d'un élément d'étanchéité (20).
  13. Réservoir (50) pour un liquide médical avec un système de connecteurs, caractérisé en ce que le système de connecteurs est un système de connecteurs selon l'une quelconque des revendications précédentes.
  14. Système comprenant un système de connecteurs selon l'une quelconque des revendications précédentes 1 à 12 ou comprenant un réservoir (50) pour un liquide médical selon la revendication 13 et un premier dispositif de prélèvement (60) avec un raccord cylindrique (61) et/ou un deuxième dispositif de prélèvement (70) avec un raccord à broche (71).
EP15813445.2A 2014-12-19 2015-12-18 Système de connecteur ayant au moins deux ports de prélèvement Active EP3233016B1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
PL15813445T PL3233016T3 (pl) 2014-12-19 2015-12-18 System konektorów z co najmniej dwoma portami wyjściowymi

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP14199473.1A EP3034062B1 (fr) 2014-12-19 2014-12-19 Système de connecteur ayant au moins deux ports de prélèvement
PCT/EP2015/080601 WO2016097346A1 (fr) 2014-12-19 2015-12-18 Système de connecteurs comprenant au moins deux ports de prélèvement

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EP3233016A1 EP3233016A1 (fr) 2017-10-25
EP3233016B1 true EP3233016B1 (fr) 2019-11-13

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EP (2) EP3034062B1 (fr)
CN (1) CN107106410B (fr)
AU (1) AU2015366189B2 (fr)
ES (1) ES2762671T3 (fr)
HK (2) HK1243313A1 (fr)
PL (1) PL3233016T3 (fr)
PT (1) PT3233016T (fr)
WO (1) WO2016097346A1 (fr)

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DE102018103937A1 (de) * 2018-02-21 2019-08-22 Fresenius Medical Care Deutschland Gmbh Vorrichtung enthaltend Dialyselösung oder Dialyselösungskonzentrat
US10970614B2 (en) * 2018-06-21 2021-04-06 Rosemount Inc. Single-use pressure transducer disposable interface
JP7101900B2 (ja) * 2019-01-31 2022-07-15 ウェスト・ファーマ・サービシーズ・アイエル・リミテッド 液体移送装置
CN115916952A (zh) 2020-06-16 2023-04-04 美国圣戈班性能塑料公司 采样系统及其使用方法

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Also Published As

Publication number Publication date
EP3034062B1 (fr) 2017-03-22
CN107106410B (zh) 2020-10-27
HK1243312A1 (zh) 2018-07-13
EP3034062A1 (fr) 2016-06-22
EP3233016A1 (fr) 2017-10-25
US20180049947A1 (en) 2018-02-22
US11013662B2 (en) 2021-05-25
ES2762671T3 (es) 2020-05-25
HK1243313A1 (zh) 2018-07-13
PT3233016T (pt) 2020-02-05
PL3233016T3 (pl) 2020-05-18
WO2016097346A1 (fr) 2016-06-23
AU2015366189A1 (en) 2017-06-29
AU2015366189B2 (en) 2019-11-21
CN107106410A (zh) 2017-08-29

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