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EP2629837A2 - Capuchon protecteur pour raccord - Google Patents

Capuchon protecteur pour raccord

Info

Publication number
EP2629837A2
EP2629837A2 EP11771143.2A EP11771143A EP2629837A2 EP 2629837 A2 EP2629837 A2 EP 2629837A2 EP 11771143 A EP11771143 A EP 11771143A EP 2629837 A2 EP2629837 A2 EP 2629837A2
Authority
EP
European Patent Office
Prior art keywords
connector
cap
protective cap
swab
protective
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.)
Withdrawn
Application number
EP11771143.2A
Other languages
German (de)
English (en)
Inventor
Ismael Rahimy
Torsten Brandenburger
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Fresenius Kabi Deutschland GmbH
Original Assignee
Fresenius Kabi Deutschland GmbH
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Fresenius Kabi Deutschland GmbH filed Critical Fresenius Kabi Deutschland GmbH
Priority to EP11771143.2A priority Critical patent/EP2629837A2/fr
Publication of EP2629837A2 publication Critical patent/EP2629837A2/fr
Withdrawn legal-status Critical Current

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
    • A61M39/20—Closure caps or plugs for connectors or open ends of tubes
    • 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
    • A61M39/162—Tube connectors; Tube couplings having provision for disinfection or sterilisation with antiseptic agent incorporated within the connector

Definitions

  • the invention relates to a protective cap for closing a connector for medical drug or nutrient solution containing container, a connector system and a method for cleaning and / or disinfecting a surface of a recessed membrane of a connector with a protective cap.
  • US7763006B2 discloses a protective cap which can be placed on a syringe-shaped port cleaner. Inside the protective cap, an annular sponge is provided at the bottom of the protective cap, which may have disinfectant,
  • the publication WO2009123709 A2 discloses a cleaning device which has a cap-shaped housing and a sponge arranged in the housing.
  • the sponge is soaked with disinfectants.
  • the cleaning device comprises a lid which closes the housing with the sponge to keep the sponge in the sterile state.
  • the protective cap for closing a connector for medical drug-containing container comprises an outer cap portion and an inner Kappan, wherein outer cap portion and inner cap portion between them form a substantially annular cavity for engagement of an annular connector of a connector, wherein the inner cap portion a swab for cleaning and / or disinfecting a recessed to the edge of the connector membrane of the connector.
  • annular is intended to include in particular also substantially conical, cylindrical or mixed forms.
  • connectors such as in WO2010 / 034470A1 and WO
  • Membrane is favored a nucleation, which restricts a further or repeated removal of content from the container or a multiple supply of liquid, such as a drug, after a certain time or makes it completely impossible.
  • the protective cap By means of the protective cap according to the invention, it is possible to effectively clean and / or disinfect recessed membrane connectors. Likewise, the cap allows a safe closing of the opening of the connector. The cap can be easily put on the connector, which is ensured by the formation of the inner cap area with swabs that the swab the
  • a swab is a soft or flexible body.
  • the swab is capable of deforming under pressure, in particular by a manual untwisting of the cap on a connector, and for example, to invest in a surface to be cleaned. He is squeezable, so to speak.
  • the swab is provided by an absorbent material, in particular to be able to receive a liquid detergent.
  • the swab is designed such that the entire surface exposed to the outside area can be cleaned and / or disinfected.
  • the swab can be designed such that it additionally cleans and / or disinfects the inner surface of the connecting piece adjoining the membrane.
  • the swab for example, a disc-shaped, the membrane
  • the inner cap portion includes a retaining projection to which the swab is attached.
  • a retaining projection allows a secure and permanent attachment of the swab.
  • the inner cap portion is formed with an outer surface, which corresponds to the inner surface of the connector of the connector at least partially, so that come to rest with the placement of the connector, these two surfaces at least in a section on each other. In this way it is possible to create a seal between the cap and the connector which can reduce the risk of unwanted leakage of contents from the container.
  • the outer surface of the retaining projection corresponds to the inner surface of the connecting piece, so that with the placement of the connector, these two surfaces come to rest on each other, at least in one section.
  • the cap made of a rigid material which is preferred, can on This way, with a likewise made of a rigid material fitting a simple to manufacture and to be achieved sealing can be achieved.
  • the protective cap or the material chosen for protective cap is impermeable to air and liquids. Thereby, a secure sealing can be achieved and a possible evaporation of a cleaning agent can be prevented or at least reduced.
  • the protective cap according to the invention is particularly suitable for cleaning needle-free connectors. It is particularly preferred that the protective cap is designed as a male part of a Luer connector or a Luer-Lock connector (ISO 594-1: 1986 / EN 20594-1: 1993 or ISO 594-2: 1998 / EN 1707: 1996).
  • the swab comprises a cleaning agent, for example
  • the swab can be formed, for example, liquid-absorbent and soaked with such a detergent.
  • FIG. 1 shows a perspective view of a first embodiment of a protective cap according to the invention
  • Fig. 2 is a view of the protective cap shown in Fig. 1, wherein the
  • FIG. 3 is a view of the protective cap shown in Fig. 1 with swab
  • Fig. 5 shows a section through the protective cap with a second
  • FIG. 6 shows a section through the protective cap with a third swab
  • FIG. 7 shows a section through the protective cap with the second swab and a barrier film
  • FIG. 8 is a perspective view of a connector system with a
  • Fig. 9 is a longitudinal section through that shown in Fig. 8
  • Connector system 10 is a perspective view of a second embodiment of a protective cap
  • FIG. 10 is a further perspective view of the protective cap shown in Fig. 10,
  • FIG. 12 is a perspective view of a connector system with a
  • Fig. 13 is a longitudinal section through that shown in Fig. 12
  • FIGS. 8 and 9 show a connector system which has such a protective cap 1 and a connector 20.
  • the protective cap 1 is for the safe closing of a connector 20 for medical drug or nutrient solution containing containers, for example of
  • the protective cap includes an outer
  • Cap portion 2 an inner cap portion 3 and a cap bottom 7.
  • the outer cap portion 2 and the inner cap portion 3 are connected to each other via the cap bottom 7.
  • the outer cap portion 2, the inner cap portion 3 and the cap bottom 7 are preferably formed in one piece.
  • the outer cap portion 2 and the inner cap portion 3 form between them, that is, between the inner surface of the outer cap portion 2 and the outer surface of the inner cap portion 3, a substantially annular cavity 4 for engaging an annular
  • Connector 21 of the connector 20 from.
  • Cap portion has a plurality of ribs 13, which facilitate handling of the protective cap 1.
  • the inner cap portion 3 includes a holder protrusion 6 and a swab 5.
  • the holding protrusion 6 is disposed in the center of the cap bottom 7.
  • Outer diameter of the retaining projection 6 here has the dimensions of a Luer cone.
  • the retaining projection 6 comprises a recess 12 into which the swab 5 is inserted.
  • the swab 5 has, in particular at least in sections, a substantially T-shaped cross-section.
  • the swab 5 is located with a portion of its back on the front side of the holder projection 6.
  • the recess 12 allows a secure
  • the recess 12 is formed in the longitudinal direction step-shaped, see for example Fig. 4- 7.
  • the swab 5 is exclusively part of the inner cap area 3.
  • Outer cap portion 2, cap bottom 7 and retaining projection 6 are made as a one-piece injection molded part of a hard plastic, for example, PP, PE, PA, PS or mixture of PP and SEBS.
  • a hard plastic for example, PP, PE, PA, PS or mixture of PP and SEBS.
  • the swab 5 is designed to clean and / or disinfect a membrane 23 of the connector 20 which is set back to the edge 22 of the connection piece 21, see FIG. 9.
  • the swab 5 extends, in particular laterally, beyond the holder projection 6 of the inner cap area 3. This ensures that the swab 5, the membrane 23 as large as possible, preferably the entire exposed surface, touch, clean and / or disinfect.
  • the swab 5 is disc-shaped with its end facing the membrane 23 end portion. The swab 5 does not protrude out of the protective cap 1.
  • the top of the swab 5 is lower than the top or front side of the protective cap 1.
  • the position or height of the swab 5 in the cap 1 and the thickness of the swab 5 are particularly chosen or matched to one another that a valve function of the connector 20th with screwed cap 1 is not or not significantly impaired.
  • the top side of the swab 5 is at least 2 mm lower than the end face of the protective cap 1.
  • FIGS. 4-6 show different variants of the swab.
  • the swab 5 is integrally formed.
  • the swab 5 is preferably by filling the retaining projection 6 with a
  • liquid-absorbent material for example of polyurethanes, ABS, nylon, polyester or polyolefins.
  • the swab 5 ' is formed in two parts with a holding part 10 and a swab part 1 1.
  • the dab part 1 1 is preferably made of synthetic, foam, paper or cotton, which is fixed via an undercut in the cavity of the holding part 10, in the retaining projection 6 by pressing, gluing or jamming
  • the swab 5 is likewise designed in two parts with a holding part 10 and a swab part 1.
  • the holding part 10 is formed as a rod which is fastened in the holding protrusion 6 via a positive connection.
  • the one-piece swab 5 and the swab part 1 1 are made of a soft or flexible, more preferably made of an elastic material to contact the To be able to adapt the surface of the membrane 23 and to be able to touch them in particular over the entire surface.
  • the swab 5 is provided by an absorbent material.
  • the swab 5, 5 ', 5 " is in these embodiments with a
  • Soaked disinfectant for example with isopropanol, ethanol, Polyvidon-iodine or another disinfectant.
  • Other cleaning agents are also possible.
  • the outer cap portion 2 has a fastening means 8, which makes it possible to permanently connect the protective cap 1 with a connector 20.
  • the fastening means 8 is formed as an internal thread that can cooperate with an external thread of the connector 20 (not visible).
  • the protective cap 1 is permanently but detachably attachable to the connector 20.
  • the protective cap 1 further comprises a barrier film 9.
  • the barrier film 9 hermetically seals the swab 5, 5 ', 5 "comprising the inner area of the protective cap 1.
  • the barrier film 9 thus prevents contamination of the inner area and also the evaporation of the cleaning agent in this embodiment circumferentially attached to the outer edge 14 of the outer cap portion 2,
  • the barrier film 9 is formed with a protruding tab, which allows easy manual detachment of the barrier film 9.
  • the barrier film 9 can be, for example, an aluminum composite film or a plastic mono or composite film.
  • the outer surface of the inner cap portion 3 is conical here.
  • the protective cap 1 is designed as a male part of a Luer lock connector.
  • FIGS. 8 and 9 show an embodiment of a connector system according to the invention comprising a protective cap 1 and a connector 20.
  • Such connectors 20 are known, for example, from WO2010 / 034470 A1 and WO 2005/037362 A1. As far as the construction of such connectors 20 is referred to the cited documents.
  • the connector 20 is in the range of
  • Connector 21 formed as a female part of a Luer connector.
  • the inner cap portion 3 of the protective cap 1 is formed with such a length that the surface of the diaphragm touches 23, but the diaphragm 23 is not opened. This maintains a sealing effect of the membrane 23, for example in the case of a self-sealing membrane 23.
  • the edge region 24 forms a stop for the edge 14 of the outer cap portion 2. In this way, an end position of the protective cap 1 is defined.
  • FIGS. 10-13 show a second embodiment of a device according to the invention
  • Fastening means 8 ' are here designed as four resiliently yielding hooks, which are integrally formed on the outer surface of the outer cap portion 2. When placing the protective cap 1 on the connector 20 and reaching the end position hook the hook 8 'resiliently behind the edge region 24 of the connector 20 a.
  • the hooks 8 ' can with the outer cap portion 2, inner
  • Cap area 3 and cap base 7 integrally or in several parts be formed as an injection molded plastic.
  • the protective cap V with the snap hooks can also be made detachable.
  • the protective cap V with the snap hooks can also be dispensed with the internal thread of the cap. The attachment of the cap with the connector via
  • Attachment are formed.
  • the protective cap in the form be formed so that the hooks yield with a sufficiently high train on the cap and from its position in which you engage behind the edge portion 24 of the connector 20, independently (for example, in which the hook instead of a rectangular formed with an oblique or rounded rear handle are).

Landscapes

  • Health & Medical Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Public Health (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Hematology (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Pulmonology (AREA)
  • Epidemiology (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Apparatus For Disinfection Or Sterilisation (AREA)
  • External Artificial Organs (AREA)
  • Packages (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
  • Media Introduction/Drainage Providing Device (AREA)

Abstract

L'invention concerne un capuchon protecteur destiné à obturer un raccord pour récipients contenant une substance active médicinale, un système de raccord et un procédé de nettoyage et/ou de désinfection d'une surface d'une membrane d'un raccord placée en retrait. Ce capuchon protecteur (1, 1') comprend une partie capuchon externe (2) et une partie capuchon interne (3), un espace creux (4) sensiblement annulaire, pour l'insertion d'une pièce de raccordement annulaire (21) d'un raccord (20), étant formé entre la partie capuchon externe (2) et la partie capuchon interne (3), et la partie capuchon interne (2) comportant un tampon (5, 5', 5'') pour le nettoyage ou la désinfection d'une membrane (23) du raccord (20), placée en retrait du bord (22) de la pièce de raccordement (21).
EP11771143.2A 2010-10-20 2011-10-19 Capuchon protecteur pour raccord Withdrawn EP2629837A2 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
EP11771143.2A EP2629837A2 (fr) 2010-10-20 2011-10-19 Capuchon protecteur pour raccord

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US39477710P 2010-10-20 2010-10-20
EP10188134A EP2444117A1 (fr) 2010-10-20 2010-10-20 Cape de protection pour un connecteur
PCT/EP2011/068236 WO2012052467A2 (fr) 2010-10-20 2011-10-19 Capuchon protecteur pour raccord
EP11771143.2A EP2629837A2 (fr) 2010-10-20 2011-10-19 Capuchon protecteur pour raccord

Publications (1)

Publication Number Publication Date
EP2629837A2 true EP2629837A2 (fr) 2013-08-28

Family

ID=43618876

Family Applications (2)

Application Number Title Priority Date Filing Date
EP10188134A Withdrawn EP2444117A1 (fr) 2010-10-20 2010-10-20 Cape de protection pour un connecteur
EP11771143.2A Withdrawn EP2629837A2 (fr) 2010-10-20 2011-10-19 Capuchon protecteur pour raccord

Family Applications Before (1)

Application Number Title Priority Date Filing Date
EP10188134A Withdrawn EP2444117A1 (fr) 2010-10-20 2010-10-20 Cape de protection pour un connecteur

Country Status (7)

Country Link
US (1) US20120111368A1 (fr)
EP (2) EP2444117A1 (fr)
CN (1) CN103260696B (fr)
AU (1) AU2011317631B2 (fr)
CA (1) CA2814971A1 (fr)
WO (1) WO2012052467A2 (fr)
ZA (1) ZA201302809B (fr)

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AU2011317631A1 (en) 2013-05-02
ZA201302809B (en) 2014-06-25
WO2012052467A3 (fr) 2012-11-01
AU2011317631B2 (en) 2015-06-11
CN103260696A (zh) 2013-08-21
US20120111368A1 (en) 2012-05-10
CA2814971A1 (fr) 2012-04-26
EP2444117A1 (fr) 2012-04-25
WO2012052467A2 (fr) 2012-04-26
CN103260696B (zh) 2016-01-13

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