WO2010142385A1 - Dispositif pour l'assemblage stérile d'articles médicaux à usage unique - Google Patents

Dispositif pour l'assemblage stérile d'articles médicaux à usage unique Download PDF

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Publication number
WO2010142385A1
WO2010142385A1 PCT/EP2010/003240 EP2010003240W WO2010142385A1 WO 2010142385 A1 WO2010142385 A1 WO 2010142385A1 EP 2010003240 W EP2010003240 W EP 2010003240W WO 2010142385 A1 WO2010142385 A1 WO 2010142385A1
Authority
WO
WIPO (PCT)
Prior art keywords
guide element
pipe section
sleeve
connector
connection
Prior art date
Application number
PCT/EP2010/003240
Other languages
German (de)
English (en)
Inventor
Heinz Meise
Original Assignee
Heinz Meise 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 Heinz Meise Gmbh filed Critical Heinz Meise Gmbh
Priority to EP10723525A priority Critical patent/EP2440280A1/fr
Publication of WO2010142385A1 publication Critical patent/WO2010142385A1/fr

Links

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
    • A61M39/16—Tube connectors; Tube couplings having provision for disinfection or sterilisation
    • A61M39/18—Methods or apparatus for making the connection under sterile conditions, i.e. sterile docking
    • 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
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/168—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body
    • A61M5/16877—Adjusting flow; Devices for setting a flow rate
    • A61M5/16881—Regulating valves
    • 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
    • A61M39/16—Tube connectors; Tube couplings having provision for disinfection or sterilisation
    • A61M39/165—Shrouds or protectors for aseptically enclosing the connector

Definitions

  • the invention relates to a device for the sterile connection of medical disposable articles, consisting of an outlet connector having a tube piece, which is provided with a seal and adjacent thereto with exit windows and is closed at its one end with a closure, and an inlet connector, which has a receptacle in which a guide element is arranged.
  • Devices of the type considered here are used in a variety of ways in the medical field, for example in the field of blood donations, blood transfusions, dialysis and the like for connecting hoses, centrifuge bells, etc.
  • a reliable connection of the respective disposable articles is an essential criterion of such devices in the sterile - unit of connection.
  • the device must in any case ensure that when connecting the disposable items no bacteria or foreign substances enter the compound, which may then enter with the liquid in the body of the patient and trigger infections there.
  • the invention aims to remedy this situation.
  • the invention has for its object to provide a device for the sterile connection of medical disposable articles, can be dispensed with in the sterilization of the articles to be joined and yet a sterile connection is ensured.
  • the tube piece is arranged with its exit windows in the guide element movable.
  • the invention provides a device for the sterile connection of medical disposable articles, which provides sterility of the connection without sterilizing the respective articles, so that all hygiene requirements are met. This is ensured by the fact that the outlet connector partially enters with its sterile area in the sterile area of the inlet connector. At the same time, the handling of the connection is considerably simplified, as can be dispensed with the hitherto customary use of equipment for disinfection and the like.
  • a sleeve is slidably mounted on the pipe piece, on which a union nut is provided.
  • the sleeve serves to guide the pipe section and at the same time, in conjunction with the union nut, to reliably fasten the outlet and inlet connectors.
  • the guide element is penetrated by a longitudinal bore in which a plug is located.
  • the plug closes off the sterile area of the inlet connector against ambient air so that sterility is ensured until the device is opened.
  • passage openings are formed in the guide element. The openings allow after opening the device, the flow of liquid through the inlet connector in the direction of the hose.
  • the plug is displaceable along the longitudinal bore to behind the passage openings.
  • the passage openings are in the sterile area until a flow through the device is released.
  • this design ensures that the flow is not obstructed by the plug.
  • a stop is provided on the pipe section. The stop limits the insertion depth of the pipe section in the direction of the inlet connector.
  • the stop is provided with securing clips.
  • the securing clips grip in the inserted position of the pipe section in the inlet connector, the free end of the sleeve, whereby the pipe section is secured against unintentional withdrawal from the inlet connector.
  • FIG. 2 shows the illustration of the inlet and outlet connectors forming the device in the unconnected state
  • FIG 3 shows the device in connected condition of inlet and outlet connectors.
  • 4 shows the section through an inlet connector.
  • 5 shows the section through an outlet connector
  • 6 shows the section through the inlet and outlet connector in the connected and closed state.
  • Fig. 7 shows the section through inlet and outlet connector in connected and open state.
  • the device selected as an exemplary embodiment for the sterile connection of disposable medical articles consists of an outlet connector 1 and an inlet connector 2, which engage in one another in a displaceable manner. Outflow connector 1 and inlet connector 2 are each fired with a cap 3 before their connection.
  • the outlet connector 1 has a pipe section 4 which is closed at its one end with a closure 5.
  • the closure 5 is preferably coated with silver ions. Adjacent to the closure 5, the pipe section 4 is provided with exit windows 41, wherein in the exemplary embodiment two opposing outlet windows 41, which have the shape of an oblong hole, are provided. Immediately adjacent to the exit windows 41, an annular groove 42 is formed in the pipe section 4, which serves to receive a seal 6.
  • a stop 43 is provided which is provided with securing clips 44.
  • the securing clips 44 are aligned parallel to the longitudinal center line of the pipe section 4 in the embodiment.
  • There are two securing brackets 44 are provided.
  • a connecting piece 45 is formed adjacent to the stop 43, which serves for connection to the respective hose.
  • the outlet connector 1 further comprises a sleeve 7 which is slidably mounted on the pipe section 4.
  • the sleeve 7 is of rotationally symmetrical design and has at its one end a conical surface 71 which serves to receive the closure cap 3.
  • a shoulder 72 is formed, which forms the free end of the sleeve 7.
  • the inner diameter of the sleeve 7 substantially corresponds to the outer diameter of the closure 5.
  • the sleeve 7 is surrounded by a union nut 8, which is internally provided with a cylindrical surface 81, whose diameter substantially corresponds to the outer diameter of the sleeve 7. Subsequent to the cylindrical surface 81, the union nut 8 is provided with an internal thread 82 whose diameter is greater than that of the cylindrical surface 81. At the transition between cylindrical surface 81 and internal thread 82, the union nut 8 is supported on the conical surface 71. Outside, the union nut is provided with a polygon 83, which serves as Einschraub Anlagen.
  • the inlet connector 2 has a receptacle 9, which is essentially formed by a hollow cylinder 91. The hollow cylinder 91 is followed by a taper 92, which extends into an inlet pipe 93, which serves for connection to the hose.
  • a guide element 10 is arranged, which is penetrated by a longitudinal bore 101.
  • a plug 102 which is preferably coated with silver ions.
  • a disc 103 is arranged, which has a contact surface 104 on its side facing the receiving 9, with which the guide member 10 is sealed against the receptacle 9. Adjacent to the disc 103 through openings 105 are formed in the guide member 10, which have a rectangular shape.
  • an external thread 106 is formed on the guide element 10, which corresponds in the assembled state of the device with the internal thread 82 of the union nut 8.
  • the connection between the union nut 8 and guide element 10 instead of the thread combination 82/106 may also be formed by a snap connection.
  • the guide element 10 is provided in the region of the external thread 106 with a conical inner surface 107, which corresponds in the assembled state with the conical surface 71 of the sleeve 7.
  • the outlet connector 1 and the inlet connector 2 are each closed with a closure cap 3. Since the cap 3 has a conical shape overall, it is plugged on the side of the outlet connector 1 on the conical surface 71 of the sleeve 7, inserted on the side of the inlet connector 2 in the conical inner surface 107 of the guide element 10.
  • the provided in the middle of the cap 3 ring 31 serves on the one hand as a stop, on the other hand as a removal aid.
  • the closure caps 3 are first removed. Then, the union nut 8 is screwed with its internal thread 82 on the external thread 106 of the guide element.
  • the pipe section 4 is moved in the direction of the intake connec- tor 2.
  • the pipe section 4 moves within the sleeve 7, wherein the seal 6 is moved along the sleeve.
  • the closure 5 presses the stopper 102 along the guide element 10 in the direction of the inlet tube 93.
  • the device has reached its final flow position when the stopper 102 has reached the end of the guide element 10, ie is displaced beyond the passage openings 105, respectively When the stop 43 comes to rest with the sleeve 7 ( Figure 7).
  • the exit windows 41 are arranged in this position in the region of the passage openings 105, so that the liquid can flow from the pipe section 4 through the guide element 10 into the receptacle 9 in order to reach the hose connected thereto.
  • the flow can also take place in the reverse direction, ie from the receptacle 9 through the guide member 10 in the pipe section 4, to get into the hose connected there.
  • the device according to the invention provides a sterile connection possibility of medical disposable articles. This is guaranteed by not being in Connected state of the respective medical disposable article on the one hand, the outlet connector 1 is closed in its end facing away from the hose by the closure 5 and at the same time the exit window 41 are surrounded by the sleeve 7, wherein the transition from sleeve 7 to pipe section 4 by means of the seal 6 is sealed , As a result, provided for the flow of the respective liquid inner region of the pipe section 4 is sealed from the environment.
  • the flow through the device is released only by the displacement of the pipe section 4 in the direction of the receptacle 9 and the entry of the closure 5 in the guide element 10 after passing through the openings 105.
  • the union nut 8 is screwed to the guide member 10, so far as a contact with the environment is excluded. Consequently, by moving the sterile area within the pipe section 4 into the sterile area of the guide element 10, a sterile connection is created. Neither the sterile area in the outlet connector 1 nor the sterile area in the inlet connector 2 thus come into contact with the ambient air, so that the highest degree of sterility is ensured.

Landscapes

  • Health & Medical Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pulmonology (AREA)
  • Vascular Medicine (AREA)
  • Physics & Mathematics (AREA)
  • Fluid Mechanics (AREA)
  • Epidemiology (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

La présente invention concerne un dispositif pour l'assemblage stérile d'articles médicaux à usage unique, constitué d'un raccord de sortie (1) comprenant une pièce tubulaire (4) qui est munie d'un joint (6) et de fenêtres de sortie (41) contiguës à celui-ci et est fermée à sa première extrémité par un dispositif de fermeture (5). Le dispositif d'assemblage est également constitué d'un raccord d'entrée (2) comprenant un logement (9) dans lequel est agencé un élément de guidage (10). La pièce tubulaire (4) est conçue de manière à pouvoir se déplacer avec ses fenêtres de sortie (41) dans l'élément de guidage (10).
PCT/EP2010/003240 2009-06-10 2010-05-27 Dispositif pour l'assemblage stérile d'articles médicaux à usage unique WO2010142385A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
EP10723525A EP2440280A1 (fr) 2009-06-10 2010-05-27 Dispositif pour l'assemblage stérile d'articles médicaux à usage unique

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE202009008274.1 2009-06-10
DE200920008274 DE202009008274U1 (de) 2009-06-10 2009-06-10 Vorrichtung zum sterilen Verbinden von medizinischen Einwegartikeln

Publications (1)

Publication Number Publication Date
WO2010142385A1 true WO2010142385A1 (fr) 2010-12-16

Family

ID=41060980

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/EP2010/003240 WO2010142385A1 (fr) 2009-06-10 2010-05-27 Dispositif pour l'assemblage stérile d'articles médicaux à usage unique

Country Status (3)

Country Link
EP (1) EP2440280A1 (fr)
DE (1) DE202009008274U1 (fr)
WO (1) WO2010142385A1 (fr)

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9901729B2 (en) 2013-03-29 2018-02-27 Emd Millipore Corporation Sterile connection/disconnection coupling and method
US11590333B2 (en) 2018-01-22 2023-02-28 Saint-Gobain Performance Plastics Corporation Tubular coupling

Families Citing this family (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE202014100585U1 (de) 2014-02-11 2014-04-22 Heinz Meise Gmbh Vorrichtung zum sterilen Verbinden von medizinischen Einwegartikeln
DE102019123806A1 (de) * 2019-09-05 2021-03-11 Fresenius Medical Care Deutschland Gmbh Medizinischer Konnektor mit automatischer Abdichtung bei der Dekonnektion
DE202023104370U1 (de) 2023-08-02 2023-10-12 Heinz Meise GmbH Vorrichtung zur Abfüllung von Blutprodukten

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4810241A (en) * 1980-06-09 1989-03-07 Rogers Phillip P Ambulatory dialysis system and connector
EP0639389A1 (fr) * 1993-08-17 1995-02-22 Franz A. Dieringer Raccord de conduits tubulaires
WO2004011077A1 (fr) * 2002-07-26 2004-02-05 Millipore Corporation Connecteur sterile
WO2008017727A1 (fr) * 2006-08-11 2008-02-14 Iperboreal Pharma S.R.L. Dispositif de couplage et son utilisation

Family Cites Families (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE102005030319B4 (de) * 2005-06-29 2015-11-12 Sartorius Stedim Biotech Gmbh Verbinder, Verbindersystem und Verwendung
FR2934337B1 (fr) * 2008-07-23 2010-09-17 Millipore Corp Dispositifs de raccordement et systeme de raccordement male-femelle les comportant

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4810241A (en) * 1980-06-09 1989-03-07 Rogers Phillip P Ambulatory dialysis system and connector
EP0639389A1 (fr) * 1993-08-17 1995-02-22 Franz A. Dieringer Raccord de conduits tubulaires
WO2004011077A1 (fr) * 2002-07-26 2004-02-05 Millipore Corporation Connecteur sterile
WO2008017727A1 (fr) * 2006-08-11 2008-02-14 Iperboreal Pharma S.R.L. Dispositif de couplage et son utilisation

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9901729B2 (en) 2013-03-29 2018-02-27 Emd Millipore Corporation Sterile connection/disconnection coupling and method
US10675454B2 (en) 2013-03-29 2020-06-09 Emd Millipore Corporation Sterile connection/disconnection coupling and method
US10940307B2 (en) 2013-03-29 2021-03-09 Emd Millipore Corporation Sterile connection/disconnection coupling and method
US11590333B2 (en) 2018-01-22 2023-02-28 Saint-Gobain Performance Plastics Corporation Tubular coupling

Also Published As

Publication number Publication date
DE202009008274U1 (de) 2009-09-10
EP2440280A1 (fr) 2012-04-18

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