WO2021099437A1 - Élément d'accouplement pour un système de transfert fluidique fermé, élément d'accouplement homologue pour un tel élément d'accouplement et système d'accouplement - Google Patents

Élément d'accouplement pour un système de transfert fluidique fermé, élément d'accouplement homologue pour un tel élément d'accouplement et système d'accouplement Download PDF

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Publication number
WO2021099437A1
WO2021099437A1 PCT/EP2020/082623 EP2020082623W WO2021099437A1 WO 2021099437 A1 WO2021099437 A1 WO 2021099437A1 EP 2020082623 W EP2020082623 W EP 2020082623W WO 2021099437 A1 WO2021099437 A1 WO 2021099437A1
Authority
WO
WIPO (PCT)
Prior art keywords
coupling element
coupling
mating
sealing element
housing
Prior art date
Application number
PCT/EP2020/082623
Other languages
German (de)
English (en)
Inventor
Karl Martin Berg
Nathanael Fischer
Florin Kopp
Gerrit Seidel
Original Assignee
B. Braun Melsungen Ag
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 B. Braun Melsungen Ag filed Critical B. Braun Melsungen Ag
Priority to EP20811983.4A priority Critical patent/EP4061469A1/fr
Publication of WO2021099437A1 publication Critical patent/WO2021099437A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/10—Tube connectors; Tube couplings
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/10—Tube connectors; Tube couplings
    • A61M39/1011—Locking means for securing connection; Additional tamper safeties
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/22—Valves or arrangement of valves
    • A61M39/26—Valves closing automatically on disconnecting the line and opening on reconnection thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/10—Tube connectors; Tube couplings
    • A61M2039/1027—Quick-acting type connectors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/10—Tube connectors; Tube couplings
    • A61M2039/1033—Swivel nut connectors, e.g. threaded connectors, bayonet-connectors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/10—Tube connectors; Tube couplings
    • A61M2039/1066—Tube connectors; Tube couplings having protection means, e.g. sliding sleeve to protect connector itself, shrouds to protect a needle present in the connector, protective housing, isolating sheath
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/10—Tube connectors; Tube couplings
    • A61M2039/1072—Tube connectors; Tube couplings with a septum present in the connector
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/22—Valves or arrangement of valves
    • A61M39/26—Valves closing automatically on disconnecting the line and opening on reconnection thereof
    • A61M2039/267—Valves closing automatically on disconnecting the line and opening on reconnection thereof having a sealing sleeve around a tubular or solid stem portion of the connector
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/02—General characteristics of the apparatus characterised by a particular materials
    • A61M2205/0216—Materials providing elastic properties, e.g. for facilitating deformation and avoid breaking
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/27—General characteristics of the apparatus preventing use
    • A61M2205/276—General characteristics of the apparatus preventing use preventing unwanted use

Definitions

  • Coupling element for a closed fluid transfer system mating coupling element for such a coupling element and coupling system
  • the invention relates to a coupling element for a closed fluid transfer system, a counter coupling element for such a coupling element and a coupling system with such a coupling element and counter coupling element.
  • CMR drugs Cancorogen Mutagen Reprotoxic Drugs
  • CSTD Closed System Transfer Devices
  • Coupling systems of this type are generally associated with the terms “Dry Connection”, “Automatic Self-Sealing Technology” or “Closed Connection” and are an essential part of the realization of closed fluid transfer systems, which are used for adjustment and administration tiger CMR drugs are becoming increasingly important.
  • the object of the present invention is to provide a coupling element, a mating coupling element and a coupling system for a closed fluid transfer system, which improve the safe transfer of a fluid in a closed fluid transfer system in a connected state and in the disconnected state Minimize or prevent contamination of the environment.
  • the object of the invention is achieved by a coupling element for a closed fluid transfer system according to claim 1, a mating coupling element according to claim 9 and a coupling system according to claim 15. Further advantageous refinements of the invention emerge from the subclaims.
  • the coupling element for a closed fluid transfer system comprises a coupling element housing with a fluid connection and a coupling side, wherein the coupling element housing has a longitudinal axis extending from the fluid connection in the direction of the coupling side, a mandrel with at least one fluid opening, which is located in one on the fluid connection Dornauf recording of the housing is held and extends in the direction of the longitudinal axis into the coupling element housing, wherein the at least one fluid opening is arranged in an end portion of the dome facing the coupling side, a sealing element arranged in the coupling element housing on the coupling side, a sealing element that is in the sealing element receptacle is arranged and together with the sealing element receptacle forms at least part of a coupling-side end face of the coupling element, the sealing element receptacle with the sealing element in the direction of the longitudinal ac
  • the hse is movable between a position with a maximum distance from the fluid connection and a position with a minimum
  • the position of the sealing element receptacle at the maximum distance from the fluid connection corresponds to a position of the sealing element receptacle in the disconnected state without a mating coupling element engaging the coupling element.
  • the position of the sealing element receptacle at a minimal distance from the fluid connection corresponds to a position of the sealing element receptacle in the connected state in which the mating coupling element is connected to the coupling element for secure fluid transfer.
  • the position of the sealing element receptacle with a minimal distance from the fluid connection can also be a position with a smaller distance from the fluid connection than the distance in the connected state. In terms of secure positioning of the fluid opening of the dome in a mating coupling element, however, the position of the sealing element receptacle with a minimal distance, which corresponds to the position of the sealing element receptacle in the connected state, is sufficient.
  • the sealing element receptacle By moving the sealing element receptacle, the sealing element is also moved relative to the mandrel in the direction of the longitudinal axis. It is thus also possible to differentiate between a position of the sealing element with the maximum distance from the fluid connection and a position of the sealing element with the minimum distance from the fluid connection.
  • the above statements on the sealing element receptacle are accordingly equally applicable to the sealing element.
  • the fluid opening of the dome is either arranged in the sealing element of the coupling element or is introduced into the mating coupling element housing through the counter coupling element sealing element. Consequently, no fluid enters the coupling element housing section between the sealing element and the fluid connection or the mandrel receptacle from the fluid opening of the mandrel.
  • the requirements for fluid tightness in this section can thus also be reduced without increasing the overall risk of contamination or disrupting the subsequent flow in the connected state.
  • the end of the dome facing the coupling side including the at least one fluid opening, is arranged in the sealing element when there is the sealing element holder with the sealing element is in the position with the maximum distance from the fluid connection.
  • the mandrel does not penetrate the coupling element sealing element on the coupling side either, so that the surface of the coupling element sealing element facing the coupling side securely seals the interior of the coupling element housing.
  • the sealing element receptacle has at least one holding arm pointing in the direction of the coupling side, which protrudes beyond the sealing element in the direction of the coupling side and is designed to be able to engage in a first holding structure of a mating coupling element.
  • the holding arm of the coupling element is designed to correspond to the first holding structure of the mating coupling element.
  • the coupling element and mating coupling element are preferably held in the connected state via the holding arm in cooperation with the first holding structure.
  • the at least one holding arm and the corresponding first holding structure are configured such that the mutually facing surfaces of the coupling element sealing element and the mating coupling element sealing element are pressed against one another with a predetermined compressive force in order to be able to ensure fluid tightness.
  • the holding arm of the coupling element protrudes beyond the sealing element in the direction of the coupling side, the holding arm can also be used to guide the mating coupling element in order to contact it with the coupling element.
  • the at least one holding arm can protrude in a ring shape beyond the sealing element or, however, also only be designed in sections. If the holding arm is only formed in sections, the surface of the sealing element facing the coupling side is not covered over the entire circumference of the holding arm. The surface of the sealing element facing the coupling side and the surfaces adjoining it are thus more easily accessible for disinfection.
  • the mating coupling element is circumferentially uniform via an annular holding arm held and thus also built up a uniform compressive force with which the mutually facing surfaces of the coupling element sealing element and the counter coupling element sealing element are pressed against each other
  • the at least one holding arm has at least one snap hook, in particular at its end facing the coupling side.
  • the holding arm of the sealing element receptacle can easily engage in the first holding structure of the mating coupling element via the snap hook. In addition, this results in a predetermined holding position in a connected state.
  • the holding arm can also comprise an internally threaded section pointing inwards with respect to the longitudinal axis of the coupling element, so that the coupling element can be screwed onto the counter coupling element via a corresponding external thread section of the counter coupling element. In this way, the surface pressure of the mutually facing surfaces of the coupling element sealing element and of the mating coupling element sealing element can be adapted.
  • At least two opposing holding arms are provided.
  • At least two holding arms enable uniform holding and, compared to a holding arm, which is only provided in sections, a more uniform surface pressure.
  • the mating coupling element cannot tilt away from the coupling element.
  • the use of more than two holding arms can further support the uniform holding, the uniform surface pressure and the guidance of the mating coupling element in a connected state.
  • several holding arms distributed in sections have the advantage that between them the surface of the sealing element facing the coupling side and the adjoining surfaces are more easily accessible for disinfection.
  • the at least one holding arm has a projection which points radially outward with respect to the longitudinal axis and which corresponds to a projection of the coupling element housing which points radially inward with respect to the longitudinal axis.
  • the protrusion of the holding arm pointing radially outward with respect to the longitudinal axis can only overcome the protrusion of the coupling element housing pointing radially inward relative to the longitudinal axis in a state in which the holding arm is moved radially inward relative to the longitudinal axis.
  • the insertion section of the mating coupling element is configured in such a way that the inward movement of the holding arm over the outer contour of the insertion section of the mating coupling element is prevented until the mutually facing surfaces of the coupling element sealing element and the mating coupling element sealing element meet, in particular have a predetermined surface pressure.
  • the holding arm of the sealing element receptacle can engage in the first holding structure of the mating coupling element and can thus be moved radially inward by the first holding structure, which is located radially further inward with respect to the longitudinal axis.
  • the first holding structure of the mating coupling element is to be designed in such a way that the holding arm engages in engagement with the first holding structure by at least the amount required to overcome the projection of the coupling element housing.
  • the projection of the coupling element housing forms an inner diameter of the coupling element housing which extends further in the direction of the fluid connection in order to maintain the state in which the at least holding arm engages in the first holding structure when the you telementability moves in the direction of the fluid connection.
  • the inner diameter accordingly extends at least over the axial movement path with respect to the longitudinal axis of the radially outwardly pointing projection of the at least one holding arm.
  • the inside diameter can also change over this movement distance as long as the at least one holding arm is held in the first holding structure.
  • the inner diameter can also only be configured in sections, even if the at least one holding arm is only configured in sections and not ringför mig.
  • the at least one sectionally formed Hal tearm by the sectionally inside diameter which in its relation to the Longitudinal axis tangential width corresponds to the tangential width of the partiallyaded Deten retaining arm, guided in a movement in the direction of the Fluidanschlus ses as in a groove and is thus secured against rotation.
  • the projection of the coupling element housing pointing radially inward with respect to the longitudinal axis is in particular in a position on the radially outward-pointing projection in which the sealing element receptacle is in the position at the maximum distance from the fluid connection.
  • only a section of the coupling element housing, which includes the projection preferably protrudes beyond the surface of the coupling element sealing element facing the coupling side. As explained for the holding arm, this can improve the accessibility for disinfection.
  • the sealing element receptacle has at an end facing the fluid connection at least one protrusion pointing radially outward with respect to the longitudinal axis, which corresponds to a protrusion of the coupling element housing pointing radially inward with respect to the longitudinal axis.
  • the projection of the coupling element housing pointing radially inward with respect to the longitudinal axis forms a stop for the sealing element recording, so that the sealing element recording is in the position at the maximum distance from the fluid connection when the projection of the coupling element housing is reached.
  • the sealing element receptacle is via the interaction of its end facing the fluid connection at least one projection radially outward in relation to the longitudinal axis with the projection in relation to the longitudinal axis point radially inward, the projection of the coupling element housing held in the coupling element housing.
  • the respective projections can each be designed in a ring shape or in sections.
  • the protruding stop for the sealing element receptacle with a radial outwardly pointing projection on one facing the fluid connection The end of the sealing element receptacle cooperates, the accessibility to you telement Structure in the area of the coupling-side end face is not restricted as a result.
  • relocating a corresponding stop in the area of the coupling-side end face would not only make access to the sealing element surface more difficult and thus, for example, disinfection, but would also increase the requirements for the assembly of the individual coupling element components.
  • a front stop or front protrusion i.e.
  • the rear stop or rear projection that is to say at the end facing the fluid connection, can enable easier assembly of the end of the coupling element housing facing away from a coupling side and thus overcome the above disadvantage.
  • the protruding rear stop or rear projection on the end of the sealing element receptacle facing the fluid connection can necessitate a shorter construction form of the coupling element housing.
  • the projection of the coupling element housing pointing radially outward with respect to the longitudinal axis on the end of the sealing element facing the fluid connection can also correspond to a projection of the coupling element housing pointing radially inward with respect to the longitudinal axis, so that the telement receiving in one connected State is maintained. In this way, an unintentional separation of the mating coupling element in the connected state from the coupling element can be prevented.
  • the coupling element housing can have at least two projections pointing radially inward with respect to the longitudinal axis axially one behind the other, in particular the inward projection of the coupling element housing facing the fluid connection of the at least two projections for engaging the radially outwardly pointing projection of the sealing element receptacle is provided in the connected state.
  • the radially outwardly pointing projection of the sealing element holder provided for holding in the connected state does not have to be formed by the radially outwardly pointing projection for holding the sealing element holder in the coupling element housing, but can be provided as a further radially outwardly pointing projection.
  • the coupling element housing has at least one coupling element housing holding arm which is designed to hold the sealing element receptacle in the position at a minimal distance from the fluid connection.
  • the coupling element housing holding arm engages in a corresponding holding structure of the counter coupling element, which is formed by the first holding structure of the counter coupling element or a second holding structure of the counter coupling element.
  • the coupling element housing holding arm can also engage in a third holding structure formed by the sealing element receptacle.
  • the coupling element housing holding arm engages the first, second or third holding structure when the sealing element receptacle is in the position with the minimum distance.
  • the fluid opening of the end of the dome facing the coupling side is at least partially arranged on a side of the mating coupling element sealing element facing the mating coupling element fluid connection.
  • This state corresponds to a connected state in which a fluid can be exchanged between the coupling element and the mating coupling element.
  • the coupling element can have at least two connection stages.
  • the first connection takes place via the engagement of the holding arm of the sealing element receptacle of the coupling element in the first holding structure of the mating coupling element in a position in which the facing surfaces of the sealing element and the mating coupling element sealing element are pressed against each other with a predetermined compressive force in order to ensure fluid tightness can.
  • This position essentially corresponds to the position of the sealing element receptacle with a minimal distance from the fluid connection.
  • the second connection is then made by moving the sealing element receptacle in Direction of the fluid connection up to a position in which the coupling element housing holding arm engages in the first, second or third holding structure.
  • This position corresponds to a connected state and is in particular the position of the telement receiving device with a minimal distance from the fluid connection.
  • the fluid opening of the dome in this state for fluid exchange is at least partially, preferably completely, on a side of the mating coupling element sealing element facing the mating coupling element fluid connection.
  • the invention is also directed to a mating coupling element for coupling with the coupling element according to the invention, comprising: a mating coupling element housing with a mating coupling element fluid connection and a mating coupling side, the mating coupling element housing having a coupling element extending from the coupling element fluid connection in the direction of the mating coupling side, and a mating coupling axis element ment sealing element, which is arranged in the mating coupling element housing and, together with the mating coupling element housing, forms at least part of a face of the mating coupling element on the opposite coupling side.
  • the surface of the mating coupling element sealing element facing the mating coupling side has, in particular with respect to the longitudinal axis of the mating coupling element, a radial extent that is greater than the diameter of the dome in the area where the dome of the coupling element is received by the mating coupling element, so that the mandrel, in particular the fluid opening of the dome is sealed radially during its penetration of the mating coupling element sealing element.
  • the mating coupling element housing has at least one first holding structure on an outer surface that is radial in relation to the mating coupling element longitudinal axis. Via the first holding structure, the mating coupling element can be held in a position in which the mutually facing surfaces of the sealing element and the mating coupling element sealing element are pressed against one another with a predetermined compressive force, and / or can be held in a connected state.
  • a first holding structure is preferably provided on a radial outer surface of the mating coupling element housing with respect to the mating coupling element longitudinal axis, which is located between the mating coupling element sealing element surface facing the mating coupling element and the mating coupling element fluid connection. Accordingly, disinfection of the surface of the mating coupling element sealing element facing the mating coupling side is not hindered by the holding structure.
  • the first holding structure is formed via at least one projection which points radially outward with respect to the longitudinal axis of the counter-coupling element and which in particular forms the counter-coupling-side insertion section of the counter-coupling element housing.
  • the section of the projection facing the counter-coupling element fluid connection thus forms a shoulder into which a corresponding holding unit of the coupling element, such as the holding arm listed below, can engage.
  • the first holding structure is designed such that the at least one holding arm of the sealing element receptacle and / or the at least one coupling element housing holding arm of the coupling element can engage in the first holding structure.
  • the mating coupling element is held via the engagement in a position in which the mutually facing surfaces of the sealing element and the mating coupling element sealing element are pressed against one another with a predetermined compressive force. If the at least one coupling element housing holding arm of the coupling element engages in the first holding structure, the mating coupling element is held in a connected state.
  • the first support structure can but also be designed in such a way that both the at least one holding arm of the sealing element receptacle and the at least one coupling element housing holding arm of the coupling element engage in the first holding structure.
  • the at least one holding arm of the sealing element receptacle first engages in the first holding structure and the at least one coupling element housing holding arm of the coupling element is in a position in which it also engages in the first holding structure when the sealing element receptacle with the mating coupling element is in the position of the connected state, in particular a position of the sealing element receptacle with a minimal distance from the fluid connection was moved.
  • the coupling element housing holding arm of the coupling element can also engage indirectly in the first holding structure via the holding arm of the sealing element receptacle.
  • the at least one holding arm of the sealing element receptacle and the at least one coupling element housing holding arm of the coupling element are tangentially essentially in the same position.
  • the first holding structure is designed in such a way that the at least one holding arm of the coupling element can engage in the first holding structure
  • the mating coupling element housing has at least one second holding structure on an outer surface that is radial in relation to the mating coupling element longitudinal axis, into which the at least a coupling element housing support arm can engage.
  • the first and second holding structure can have different tangential engagement sections with respect to the longitudinal axis of the coupling element in a substantially identical axial position, which engagement sections are provided for the respective one.
  • the different engagement sections have different contouring in the area of the different engagement sections.
  • the at least one holding arm of the sealing element receptacle and the at least one coupling element housing holding arm of the coupling element are arranged tangentially offset to one another.
  • the mating coupling element housing can accordingly have two holding structures, each of which is separated from one another in the tangential direction for different interventions.
  • corresponding coupling position alignments of the mating coupling element relative to the coupling element can be specified here by the section-wise formation of the first and / or second holding structure.
  • the at least one first holding structure and the at least one second holding structure are arranged at different axial positions in relation to the counter-coupling element longitudinal axis.
  • the first and second holding structures can each be provided in their respective axial position in sections or continuously around the respective circumference of the outer surface of the mating coupling element housing.
  • the coupling position alignments of the mating coupling element with respect to the coupling element can be predetermined or freely selectable.
  • the first holding structure is closer to the counter coupling side in its axial position than the second holding structure.
  • the second holding structure does not form an interfering contour when the mating coupling element moves into the coupling housing. It can accordingly be avoided that a component of the coupling element inadvertently engages prematurely in the second holding structure, although a connected state has not yet been reached and possibly also prevents the connected state from being reached.
  • the invention is also directed to a coupling system for a closed fluid transfer system which comprises at least one coupling element according to the invention and at least one mating coupling element according to the invention, the coupling system being configured in such a way that the fluid opening of the coupling element is in a state connected to the mating coupling element, in which you telementability in the position with minimal distance to the fluid connection of the Coupling element is located at least partially on a side of the mating coupling element sealing element of the mating coupling element facing the mating coupling element.
  • the advantages of the coupling system are analogous to the advantages listed for the coupling element and mating coupling element.
  • the mandrel or the fluid opening of the dome penetrates the upper surface of the sealing element of the coupling element facing the coupling side only when the counter coupling element is held in a position via the at least one holding arm of the coupling element in which the mutually facing surfaces of the sealing element and of the mating coupling element sealing element are pressed against one another with a predetermined compressive force. Fluid tightness can thus be guaranteed before the mandrel or the fluid opening of the mandrel for fluid exchange is no longer sealed by the sealing element.
  • FIG. 1 shows a schematic cross-sectional view of a coupling element in a plane parallel to the longitudinal axis of the coupling element according to an exemplary first embodiment of the coupling element in the disconnected state;
  • FIG. 2 shows a schematic cross-sectional view of a mating coupling element in a plane parallel to the mating coupling element longitudinal axis of the mating coupling element according to an exemplary first embodiment of the mating coupling element in the disconnected state;
  • FIG. 3 shows a schematic cross-sectional view of a coupling system in a plane parallel to the longitudinal axis or the counter-coupling element longitudinal axis according to FIG exemplary first embodiments of the coupling element and the mating coupling element in the connected state.
  • Fig. 4 shows an overview of all external views of the coupling system according to Fi gures 1 to 3 and the sectional views along the section lines A-A and B-B, a perspective view and an exploded view in the disconnected state;
  • Fig. 5 shows an overview of all external views of the coupling system according to Fi gures 1 to 3 and the sectional views along the section lines A-A and B-B in the connected state.
  • the coupling element 100 comprises a sealing element receptacle 20, in which a sealing element 21 is arranged on a side of the sealing element receptacle 20 facing the coupling side 13 and, together with the sealing element receptacle 20, forms at least part of a coupling-side end face of the coupling element 100, as well as an egg Mandrel 30 with at least one fluid opening 31, which is held in a mandrel receptacle 11 of the housing 10 arranged on the fluid connection 12 and extends in the direction of the longitudinal axis L1 into the coupling element housing 10, the at least one fluid opening in an end section of the mandrel 30 facing the coupling side is arranged.
  • the sealing element receptacle 20 in which a sealing element 21 is arranged on a side of the sealing element receptacle 20 facing the coupling side 13 and, together with the sealing element receptacle 20, forms at least part of a coupling-side end face of the coupling element 100, as well as an egg Mandrel 30
  • the sealing element receptacle 20 has a projection 25 which points radially outward with respect to the longitudinal axis L1 and which, on a radial inward direction with respect to the longitudinal axis L1, send projection 15 of the coupling element housing 10 rests.
  • This stop defines the position of the sealing element receptacle 20 at the maximum distance from the fluid connection, which here corresponds to the disconnected state.
  • the sealing element receptacle also has second holding arms 22 which protrude in the direction of the coupling side 13 beyond the sealing element 21 and are designed to be able to engage in a first holding structure 43 of a mating coupling element 200 (FIG. 2).
  • each holding arm 22 comprises at its end facing the coupling side 13 in each case a snap hook 22a pointing radially inward with respect to the longitudinal axis.
  • each end of the retaining arms 22 facing the coupling side 13 there is a projection pointing radially outward with respect to the longitudinal axis L1 22b is provided, which corresponds to a projection 14 of the coupling element housing 10 which points radially inward with respect to the longitudinal axis L1.
  • the respective half-tear-side projection 22b rests next to a side facing the fluid connection 12, that is, in the position of the sealing element receptacle 20 at a maximum distance from the fluid connection 12 on the projection 14 on the coupling element housing side.
  • FIG. 2 shows a schematic cross-sectional view of a mating coupling element 200 in a plane parallel to the mating coupling element longitudinal axis L2 of the mating coupling element 200, which extends from a mating coupling element fluid connection
  • the mating coupling element 200 comprises a mating coupling element sealing element 50, which is arranged in the counter coupling element housing 40 and, together with the mating coupling element housing 40, forms at least part of a counter coupling-side end face of the mating coupling element 200.
  • the end of the mating coupling element housing 40 facing the mating coupling side 42 adjoins the Counter-coupling-side end face in the direction of the counter-coupling element fluid connection 41 has an insertion section 44.
  • the insertion section 44 is formed by a section of the mating coupling element housing 40 pointing radially outward in relation to the mating coupling element longitudinal axis L2 and in relation to a section of the mating coupling element housing 40 which adjoins the insertion section 44 in the direction of the mating coupling element fluid connection 41.
  • the offset formed as a result embodies the holding structure 43, into which the holding arms 22 of the sealing element receptacle 20 of the coupling element 100 can engage.
  • the embodiment of the mating coupling element 200 shown and described is, for example, the mating coupling-side end face of the mating coupling element 200 freely accessible for disinfection.
  • FIG. 3 shows the coupling element 100 described above and the corresponding mating coupling element 200 in a coupling system 300 in the connected state in which the sealing element receptacle 20 of the coupling element 100 is in a position with a minimal distance from the fluid connection 12, and the fluid opening 31 of the Dome 30 is arranged on a side of the mating coupling element sealing element 50 of the mating coupling element 200 facing the mating coupling element fluid connection 41.
  • the procedure for inserting the mating coupling element 200 into the coupling element 100 is described below. It is irrelevant here whether the mating coupling element 200 is moved in the direction of the coupling element 100 or vice versa. Based on an assumed movement of the mating coupling element 200 in the direction of the fluid connection 12 of the coupling element 100 along the mating coupling element longitudinal axis L2 or the longitudinal axis L1, the insertion section 44 is inserted into the space formed between the holding arms 22 of the sealing element 21.
  • the diameter of the insertion section is dimensioned such that the holding arms 22, specifically the radially outwardly pointing projection 22b of the respective holding arms 22, cannot be moved radially inward in order to overcome the radially inwardly pointing projection 14 of the coupling element housing 10. the.
  • the insertion section 44 can also only have correspondingly dimensioned sections in the region of the holding arms 22.
  • the insertion section 44 with the above diameter extends axially in relation to the mating coupling element longitudinal axis L2 over a length which corresponds to the movement path starting at the snap hook 22a in the direction of the fluid connection 12 until reaching a position in which the mutually facing surfaces of the sealing element 21 and the counter coupling element sealing element 50 are pressed against one another with a predetermined compressive force in order to be able to ensure fluid tightness.
  • the snap hooks 22a can now be moved radially inward when the protruding fluid-tight position of the surfaces is reached, so that the radially outwardly pointing projections 22b the radially inwardly pointing protrusion 14 or, in the case of a sectional design, the radial projections 14 of the coupling element housing 10 can be overcome. This is done by further movement of the mating coupling element 200 and thus the sealing element receptacle 20 in the direction of the fluid connection 12.
  • the holding arms 22 are held in a position in which the snap hooks 22a engage in the holding structure 43 so that the insertion section 44 is held in the position in which the facing each other th surfaces of the sealing element 21 and the mating coupling element sealing element 50 are pressed against each other with a predetermined compressive force.
  • the mating coupling element 200 is now moved further into the coupling element 100 until the connected state of the coupling system 300 shown in FIG.
  • the sealing element receptacle 20 in the embodiment shown is in a position with a minimal distance from the fluid connection 12.
  • the minimum distance between the sealing element receptacle 20 and the fluid connection 12 in the connected state results from the engagement of the radially in relation to the longitudinal axis L1 outwardly pointing projection 25 at the end of the sealing element receptacle 20 facing the fluid connection into the radially inwardly pointing further projection 16 of the coupling element housing 10.
  • the connected state can be achieved by engaging at least one coupling element holding arm, not shown here, in a second holding structure, also not shown of the mating coupling element.
  • the at least one coupling element holding arm is tangentially offset to the holding arms 22 in relation to the longitudinal axis L1 and is only formed tangentially in sections, in order to always improve accessibility of the upper surface of the sealing element facing the coupling side when the configuration protrudes over the sealing element 21 in the direction of the coupling side 13 21 to enable disinfection or the like.
  • the at least one coupling element holding arm is first released from the second holding structure and the mating coupling element 200 is moved in the opposite direction to the insertion, that is, it is moved away from the fluid connection 12.
  • the A guide section 44 of the mating coupling element is pressed against each other with a predetermined compressive force in the position in the facing surfaces of the sealing element 21 and the mating coupling element sealing element 50 are held via the snap hooks 22a until the respective radially outwardly pointing projection 22b is moved out of the radially inwardly pointing projection 14, so that the respective radially outwardly pointing projection 22b is no longer in engagement with the corresponding first holding structure 43 .
  • the coupling element 100 is configured in such a way that in this position of the sealing element receptacle 20 the end of the dome 30 facing the coupling side and thus the fluid opening 31 is again arranged completely in the sealing element 21. Possible drops at this end of the dome are previously stripped off on the surface of the mating coupling element sealing element 50 facing the mating coupling element fluid connection 41. Since the mutually facing surfaces of the sealing element 21 and the mating coupling element sealing element 50 are pressed against each other with a predetermined compressive force before the engagement of the snap hook 22a with the first holding structure 43 is complete, i.e.
  • the fluid opening 31 is again arranged completely in the sealing element 21, the facing surfaces of the sealing element 21 and the mating coupling element sealing element 50 also have no traces of the fluid to be exchanged via the coupling system 300.
  • FIGS. 4 and 5 show the above-described embodiment for the coupling system again in an overview of all views in the disconnected state according to FIG. 4 and in the connected state according to FIG. 5. This results in further design features of the described embodiment.
  • the coupling element does not have to have a coupling element housing arm, for example, and the connected state may or may not be held by other additional elements, such as a clamping ring.
  • the holding arms described for the coupling element can also be formed by the mating coupling element, which in turn engages in holding structures of the coupling element.
  • the mandrel of the coupling element can also have more than one fluid opening.
  • a relative movement of the dome can also be provided as long as this does not impair the described fluid-tight states. List of reference signs

Abstract

L'invention concerne un élément d'accouplement (100) pour un système de transfert fluidique fermé qui comprend : un boîtier d'élément d'accouplement (10) muni d'un raccord de fluide (12) et d'une face accouplement (13), le boîtier d'élément d'accouplement (10) présentant un axe longitudinal (L1) s'étendant du raccord de fluide (12) dans la direction de la face accouplement (13), un mandrin (30) doté d'au moins une ouverture pour fluide (31), ladite au moins une ouverture pour fluide (31) étant ménagée dans une partie terminale du mandrin (30) tournée vers la face accouplement, une cavité de réception d'élément d'étanchéité (20) agencée dans le boîtier d'élément d'accouplement (10) sur la face accouplement, un élément d'étanchéité (21) qui est disposé dans la cavité de réception d'élément d'étanchéité (20) et forme conjointement avec la cavité de réception d'élément d'étanchéité (20) au moins une partie d'une face avant de l'élément d'accouplement (100) situé côté accouplement, la cavité de réception d'élément d'étanchéité (20) pouvant se déplacer conjointement avec l'élément d'étanchéité (21) en direction de l'axe longitudinal (L1), entre une position à distance maximale par rapport au raccord de fluide (12) et une position à distance minimale par rapport au raccord de fluide (12).
PCT/EP2020/082623 2019-11-21 2020-11-19 Élément d'accouplement pour un système de transfert fluidique fermé, élément d'accouplement homologue pour un tel élément d'accouplement et système d'accouplement WO2021099437A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
EP20811983.4A EP4061469A1 (fr) 2019-11-21 2020-11-19 Élément d'accouplement pour un système de transfert fluidique fermé, élément d'accouplement homologue pour un tel élément d'accouplement et système d'accouplement

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE102019217984.3A DE102019217984A1 (de) 2019-11-21 2019-11-21 Kupplungselement für ein geschlossenes Fluidtransfersystem, Gegenkupplungselement für ein solches Kupplungselement sowie Kupplungssystem
DE102019217984.3 2019-11-21

Publications (1)

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WO2021099437A1 true WO2021099437A1 (fr) 2021-05-27

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EP (1) EP4061469A1 (fr)
DE (1) DE102019217984A1 (fr)
WO (1) WO2021099437A1 (fr)

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE102021202578A1 (de) 2021-03-17 2022-09-22 B. Braun Melsungen Aktiengesellschaft Schlauchanschluss für einen Infusionsschlauch, Infusionsset und Verfahren zum Entlüften eines Infusionsschlauchs
EP4122524A1 (fr) * 2021-07-19 2023-01-25 Tada Medical AB Dispositif de couplage de transfert de fluide

Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20080197626A1 (en) * 2005-05-16 2008-08-21 David Coambs Coupling Device for Medical Lines
US20090069783A1 (en) * 2007-09-11 2009-03-12 Anna Ellstrom Piercing member protection device
WO2011029056A2 (fr) * 2009-09-04 2011-03-10 B. Braun Melsungen Ag Raccords sans aiguille mâles pouvant être scellés de façon étanche et sélective et procédés associés
DE202012101283U1 (de) * 2012-04-10 2013-07-15 Doris Kehl Steckverbindung
US20150126958A1 (en) * 2013-11-06 2015-05-07 Becton Dickinson and Company Limited Medical Connector Having Locking Engagement
US20190184152A1 (en) * 2016-09-26 2019-06-20 Terumo Kabushiki Kaisha Male connector, medical device, and connection method
EP3538201A1 (fr) * 2016-11-09 2019-09-18 Tada Medical AB Dispositif d'accouplement

Family Cites Families (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CA3050462A1 (fr) * 2017-01-17 2018-07-26 Becton Dickinson and Company Limited Connecteur pour systeme de transfert de fluides ferme

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20080197626A1 (en) * 2005-05-16 2008-08-21 David Coambs Coupling Device for Medical Lines
US20090069783A1 (en) * 2007-09-11 2009-03-12 Anna Ellstrom Piercing member protection device
WO2011029056A2 (fr) * 2009-09-04 2011-03-10 B. Braun Melsungen Ag Raccords sans aiguille mâles pouvant être scellés de façon étanche et sélective et procédés associés
DE202012101283U1 (de) * 2012-04-10 2013-07-15 Doris Kehl Steckverbindung
US20150126958A1 (en) * 2013-11-06 2015-05-07 Becton Dickinson and Company Limited Medical Connector Having Locking Engagement
US20190184152A1 (en) * 2016-09-26 2019-06-20 Terumo Kabushiki Kaisha Male connector, medical device, and connection method
EP3538201A1 (fr) * 2016-11-09 2019-09-18 Tada Medical AB Dispositif d'accouplement

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