EP1507502B1 - Raccord pour emballages contenant des liquides medicinaux et emballage pour liquides medicinaux - Google Patents

Raccord pour emballages contenant des liquides medicinaux et emballage pour liquides medicinaux Download PDF

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Publication number
EP1507502B1
EP1507502B1 EP20030706563 EP03706563A EP1507502B1 EP 1507502 B1 EP1507502 B1 EP 1507502B1 EP 20030706563 EP20030706563 EP 20030706563 EP 03706563 A EP03706563 A EP 03706563A EP 1507502 B1 EP1507502 B1 EP 1507502B1
Authority
EP
European Patent Office
Prior art keywords
membrane
self
connector according
connecting portion
connector
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.)
Expired - Lifetime
Application number
EP20030706563
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German (de)
English (en)
Other versions
EP1507502A1 (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
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Application filed by Fresenius Kabi Deutschland GmbH filed Critical Fresenius Kabi Deutschland GmbH
Priority to EP10002916.4A priority Critical patent/EP2191807B1/fr
Priority to SI200331857T priority patent/SI1507502T1/sl
Publication of EP1507502A1 publication Critical patent/EP1507502A1/fr
Application granted granted Critical
Publication of EP1507502B1 publication Critical patent/EP1507502B1/fr
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

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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
    • A61J1/1406—Septums, pierceable membranes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • 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
    • 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
    • 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
    • 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
    • A61J1/20—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

Definitions

  • the invention relates to a connector for medical fluid containing packaging, in particular infusion or transfusion bag, which serves for the removal of a liquid from the bag. Moreover, the invention relates to a packaging for medical fluids, in particular an infusion or transfusion bag, with such a connector.
  • the WO 96/23545 describes an infusion bag with an injection part and a removal part.
  • the injection part serves to supply a medicament by means of a syringe. It comprises a tubular connection part which is closed by a protective cap designed as a break-off part.
  • a self-sealing septum is seated in the opening portion of the connector while a pierceable membrane is disposed in the connector so that the septum will not contact the solution prior to use of the infusion bag.
  • the removal part is used to remove the solution by means of a spike.
  • a self-sealing septum does not have the removal part, otherwise the structure is similar to that of the injection part.
  • a connector for taking an infusion solution is also in the DE 197 28 775 C2 described.
  • the rohrformige connection part of the known removal part is closed by a flat membrane, which is integral with the connecting part.
  • the DE 100 30 474 C1 also shows a connector for medical fluid containing packaging.
  • connection between spike and removal part is not secured against slipping out. If the bag hangs on the tripod, there is a risk that the connection between the spike and the removal part will come off due to an unintentional pull on the hose line.
  • the invention has for its object to provide a connector for medical fluids containing packaging, in particular infusion or transfusion bag, which seals the packaging safely after pulling out the spike.
  • the inventive connector has a self-sealing membrane, which is arranged in the connection part for receiving the spike for the removal of the liquid.
  • the self-sealing membrane prevents leakage of liquid from the package after pulling out the spike.
  • the self-sealing membrane has an annular portion which merges into a dish-shaped portion, wherein the annular portion of the membrane sealingly surrounds the spike during piercing of the plate-shaped portion.
  • the special design of the membrane with the annular and plate-shaped section ensures on the one hand that the spike is securely guided when piercing the membrane and on the other ensures that the membrane after pulling out of the spike seals securely even at relatively high internal pressure in the package again . It has been shown in experiments that the special design of the membrane for the immediate reclosure is crucial, with increasing internal pressure in the packaging, the sealing of the membrane is still increased. The secure seal is not due to the material volume, but the special geometry of the membrane.
  • the tubular connection part of the connector is composed of a lower and an upper part, wherein the parts are snap-locked.
  • the self-sealing membrane is preferably clamped with elastic deformation thereof between the lower and upper parts. Consequently, the assembly of the connector can be done easily by pressing the items.
  • the annular portion of the membrane is followed by an outer portion which is clamped between the two sections.
  • the material of the plate-shaped portion of the membrane is weakened, so that the membrane with the spike can be particularly easily pierced.
  • the membrane is pre-slit crosswise. But it can also be star-shaped or the like. Pre-slit or provided only with a simple slot.
  • a second pierceable membrane is preferably disposed to form a space below the self-sealing membrane.
  • the second membrane is expediently an integral part of the tubular connecting piece.
  • both parts may have a toothing or the like, which also ensures an exact alignment of the parts during compression. Moreover, the risk of damage to the two membranes is particularly low when compressing the items.
  • the breakable closure part of the connector which serves as a tamper-evident closure, is preferably connected to the attachment part via a ring-break zone.
  • the break-off closure part preferably has a grip part which is designed in the manner of an arrow pointing upwards, it can immediately be recognized that the connector is a removal part but not an injection part.
  • the arrow is a recess in the Handle, which is immediately recognizable, without labels or the like are required. Thus, confusion of withdrawal and Zusufitzteil a packaging containing medical fluids can be avoided.
  • the lower part of the connector preferably has an upwardly pointing arrow, which is formed as a raised structure, preferably in a recessed grip.
  • the upward pointing arrow of the lower connector part allows even after canceling the closure part a unique assignment of the connector as a removal part.
  • the designed as a removal part connector 20 for medical liquid containing packaging, in particular infusion or transfusion bag has a tubular connection part 1, which is composed of a packaging side, lower portion 2 and a connection-side, upper portion 3.
  • the tubular connection part 1 thus has an upper and a lower opening 1a, 1b.
  • the connector 20 is an injection molded part made of polypropylene.
  • the lower portion 2 of the tubular connection part 1 has a lower cylindrical portion 4, which merges into an upper sleeve-shaped portion 5.
  • the cylindrical portion 4 of the lower portion 2 can be inserted into a connecting piece of a film bag and welded or glued to the neck or welded directly into the foil bag without nozzle.
  • the cylindrical portion 4 is closed at its upper end with a pierceable membrane 6, which is an integral part of the lower portion 2.
  • the injected membrane is curved downwards. Alternatively, the membrane can also be curved upwards.
  • the upper portion 3 of the tubular connection part 1 is set in snapping on the lower portion 2, wherein the upper portion 3 has a cylindrical portion 7 which surrounds the lower portion 2.
  • the inner wall of the cylindrical portion 7 of the upper portion 3 has a circumferential groove 8, in which a circumferential projection 9 on the outer wall of the sleeve-shaped portion 5 of the lower portion 2 during compression of the two sections 2, 3 snaps.
  • the self-sealing membrane 10 has an outer portion 11 which is clamped between the lower and upper portion 2, 3 of the tubular connection part 1.
  • the outer section 11 is adjoined by an upper, annular section 12, which merges into a lower dish-shaped section 14, forming a trough-shaped recess 13 on the upper side of the membrane 10.
  • In the center 15 is the plate-shaped Section 14 pre-slit crosswise or star-shaped, so that the elastic material is indeed weakened, but not severed.
  • a cap-shaped closure part 16 which closes the upper opening 1a of the connection part 1, adjoins the upper part 3 of the tubular connection part 1 via a ring breaking zone 31.
  • the closure part 16 merges into a flat grip part 17, which is provided with a recess 18 in the form of an arrow 19 pointing upwards. In the direction of the arrow 19 it can immediately be recognized that the connector 20 is not the injection part 40 but the removal part.
  • FIG. 2 shows an infusion bag filled with an infusion solution 21, which has the connector 20 for taking the infusion solution and another connector 40 for injecting a solution into the infusion bag 21.
  • the infusion bag 21 consists of two film layers 24, which are welded together at the lower and upper edges 25, 26 and the longitudinal edges 27, 28. In the upper edge 25 of the infusion bag, two connecting pieces 29, 30 are welded.
  • the tubular connecting pieces of the injection and removal part 40, 20 are inserted into the connecting pieces 29, 30 and connected to the nozzle during sterilization.
  • the tubular But fittings of the tamper-evident closures can also be formed on a trained or a kind of boat or round insert piece, which is welded between the two film layers.
  • FIG. 3 shows the Zuspritzteil 40 of the film bag 21 in a sectional view.
  • the injection part 40 has a similar structure as the extraction part 20. The corresponding parts are therefore provided with the same reference numerals.
  • the injection part 40 has a tubular connection part 1 ', which is composed of a lower and an upper portion 2', 3 '.
  • the two sections 2 ', 3' are defined with the interposition of a self-sealing membrane 10 'snapping, in which a projecting lug 8' of the lower portion 2 'in a groove 9' of the upper portion 3 'engages.
  • a flat membrane 6' is injected, which may also be curved.
  • the break-off part 16 of the removal part 20 is stopped by turning or breaking it, so that the self-sealing membrane 10 is exposed.
  • the spike of a known transfer system is now inserted, whereby the pre-slit membrane 10 is pierced and the downwardly curved membrane 6 is pierced.
  • the trough-shaped recess 13 serves as a guide for the spike.
  • the spike is sealed with the annular portion 12 of the membrane 10. Due to the special design of the injected membrane 6 of the spike is fixed in the tubular Connection part 1 held.
  • the infusion solution can be removed.
  • the self-sealing membrane 10 seals the dispensing part 20 securely even at a relatively high internal pressure. Moreover, with the special design of the injected membrane 6, the mechanical strength of the removal part 20 is increased.
  • the injection part 40 serves to inject an active substance into the infusion solution.
  • the self-sealing membrane 10' and the injected membrane 6 ' are pierced again with the injection needle of a syringe. After pulling out the needle, the injection part seals again.

Claims (10)

  1. Raccord pour emballages contenant des liquides médicaux, en particulier des poches de perfusion ou de transfusion, comportant
    - un élément de raccord (1) tubulaire destiné à recevoir une pointe pour le prélèvement du liquide, ledit élément de raccord comportant une ouverture (la) supérieure du côté raccord et une ouverture (1b) inférieure du côté emballage, et l'élément de raccord (1) tubulaire étant formé par une partie inférieure (2) et une partie supérieure (3), lesdites parties étant fixées en s'encliquetant l'une dans l'autre,
    - un élément obturateur (16) apte à être rompu, qui obture l'ouverture du côté raccord de l'élément de raccord,
    - une membrane (10) auto-étanche, disposée dans l'élément de raccord (1), laquelle peut être transpercée par la pointe pour le prélèvement du liquide, et la membrane auto-étanche comporte une partie supérieure (12) annulaire qui, en formant un creux (13) en forme de cuvette, se prolonge par une partie inférieure (14) en forme de fond, ladite partie annulaire de la membrane entourant de manière étanche la pointe lors du transpercement de la partie en forme de fond, et
    - une partie extérieure (11) étant adjacente à la partie annulaire (12) de la membrane (10) auto-étanche, et étant bloquée entre la partie inférieure et la partie supérieure de l'élément de raccord (1).
  2. Raccord selon la revendication 1, caractérisé en ce que le matériau de la partie (14) en forme de fond de la membrane (10) auto-étanche est fragilisé, de préférence par une fente réalisée au préalable.
  3. Raccord selon la revendication 1 ou 2, caractérisé en ce que la membrane (10) auto-étanche est maintenue bloquée entre la partie inférieure (2) et la partie supérieure (3) moyennant la déformation élastique de celles-ci.
  4. Raccord selon l'une quelconque des revendications 1 à 3, caractérisé en ce que dans l'élément de raccord (1) est disposée une deuxième membrane (6) propre à être transpercée, positionnée en dessous de la membrane (10) auto-étanche moyennant la formation d'un espace intermédiaire.
  5. Raccord selon la revendication 4, caractérisé en ce que la deuxième membrane (6) propre à être transpercée est une partie intégrante d'un seul tenant de l'élément de raccord (1).
  6. Raccord selon la revendication 4 ou 5, caractérisé en ce que la deuxième membrane (6) est courbée vers le haut ou le bas.
  7. Raccord selon l'une quelconque des revendications 1 à 6, caractérisé en ce que l'élément obturateur (16) est attaché à l'élément de raccord (1) par l'intermédiaire d'une zone de rupture annulaire (31).
  8. Raccord selon l'une quelconque des revendications 1 à 7, caractérisé en ce que l'élément obturateur (16) comporte un élément de préhension (17) qui est réalisé sous la forme d'une flèche (19) pointant vers le haut, ladite flèche étant un évidement (18) dans l'élément de préhension.
  9. Raccord selon l'une quelconque des revendications 1 à 8, caractérisé en ce que la partie inférieure (2) de l'élément de raccord (1) comporte une flèche (23) pointant vers le haut, qui est réalisée sous la forme d'une structure en relief, de préférence dans une cavité formant poignée (21).
  10. Emballage pour liquides médicaux, en particulier poches de perfusion ou de transfusion, comportant un raccord selon l'une quelconque des revendications 1 à 9.
EP20030706563 2002-05-27 2003-02-24 Raccord pour emballages contenant des liquides medicinaux et emballage pour liquides medicinaux Expired - Lifetime EP1507502B1 (fr)

Priority Applications (2)

Application Number Priority Date Filing Date Title
EP10002916.4A EP2191807B1 (fr) 2002-05-27 2003-02-24 Raccord pour emballages contenant des liquides médicinaux et emballage pour liquides médicinaux
SI200331857T SI1507502T1 (sl) 2002-05-27 2003-02-24 Priključek za embalaže, ki vsebujejo medicinske tekočine in embalaža za medicinske tekočine

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
DE10223560 2002-05-27
DE2002123560 DE10223560B4 (de) 2002-05-27 2002-05-27 Konnektor für medizinische Flüssigkeiten enthaltende Verpackungen und Verpackung für medizinische Flüssigkeiten
PCT/EP2003/001847 WO2003099191A1 (fr) 2002-05-27 2003-02-24 Raccord pour emballages contenant des liquides medicinaux et emballage pour liquides medicinaux

Related Child Applications (2)

Application Number Title Priority Date Filing Date
EP10002916.4A Division EP2191807B1 (fr) 2002-05-27 2003-02-24 Raccord pour emballages contenant des liquides médicinaux et emballage pour liquides médicinaux
EP10002916.4 Division-Into 2010-03-19

Publications (2)

Publication Number Publication Date
EP1507502A1 EP1507502A1 (fr) 2005-02-23
EP1507502B1 true EP1507502B1 (fr) 2010-06-02

Family

ID=29557331

Family Applications (2)

Application Number Title Priority Date Filing Date
EP10002916.4A Expired - Lifetime EP2191807B1 (fr) 2002-05-27 2003-02-24 Raccord pour emballages contenant des liquides médicinaux et emballage pour liquides médicinaux
EP20030706563 Expired - Lifetime EP1507502B1 (fr) 2002-05-27 2003-02-24 Raccord pour emballages contenant des liquides medicinaux et emballage pour liquides medicinaux

Family Applications Before (1)

Application Number Title Priority Date Filing Date
EP10002916.4A Expired - Lifetime EP2191807B1 (fr) 2002-05-27 2003-02-24 Raccord pour emballages contenant des liquides médicinaux et emballage pour liquides médicinaux

Country Status (21)

Country Link
US (2) US7828787B2 (fr)
EP (2) EP2191807B1 (fr)
JP (1) JP4526382B2 (fr)
KR (1) KR100944420B1 (fr)
CN (1) CN100398084C (fr)
AT (1) ATE469630T1 (fr)
AU (1) AU2003208752B8 (fr)
BR (1) BRPI0311342B8 (fr)
CA (1) CA2487551C (fr)
DE (2) DE10223560B4 (fr)
DK (1) DK1507502T3 (fr)
ES (1) ES2343456T3 (fr)
HK (1) HK1081430A1 (fr)
IN (1) IN2012DN01252A (fr)
MX (1) MXPA04011784A (fr)
NO (1) NO328168B1 (fr)
PL (1) PL212919B1 (fr)
PT (1) PT1507502E (fr)
SI (1) SI1507502T1 (fr)
WO (1) WO2003099191A1 (fr)
ZA (1) ZA200409019B (fr)

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BR0311342A (pt) 2005-03-22
JP4526382B2 (ja) 2010-08-18
US20050215943A1 (en) 2005-09-29
MXPA04011784A (es) 2005-03-31
DE50312773D1 (de) 2010-07-15
EP2191807B1 (fr) 2016-09-07
NO20045169L (no) 2005-02-17
DE10223560A1 (de) 2003-12-18
CN1655750A (zh) 2005-08-17
JP2005527301A (ja) 2005-09-15
CA2487551A1 (fr) 2003-12-04
NO328168B1 (no) 2009-12-21
SI1507502T1 (sl) 2010-10-29
ZA200409019B (en) 2007-08-29
AU2003208752B8 (en) 2008-07-31
DE10223560B4 (de) 2006-01-19
EP2191807A3 (fr) 2011-06-01
KR100944420B1 (ko) 2010-02-26
PL212919B1 (pl) 2012-12-31
EP2191807A2 (fr) 2010-06-02
EP1507502A1 (fr) 2005-02-23
BR0311342B1 (pt) 2013-12-31
ES2343456T3 (es) 2010-08-02
KR20050012753A (ko) 2005-02-02
AU2003208752B2 (en) 2008-07-10
US8118802B2 (en) 2012-02-21
ATE469630T1 (de) 2010-06-15
PT1507502E (pt) 2010-06-28
WO2003099191A1 (fr) 2003-12-04
DK1507502T3 (da) 2010-09-20
US20110022024A1 (en) 2011-01-27
IN2012DN01252A (fr) 2015-05-15
CA2487551C (fr) 2014-05-20
AU2003208752A1 (en) 2003-12-12
HK1081430A1 (en) 2006-05-19
BRPI0311342B8 (pt) 2021-06-22
CN100398084C (zh) 2008-07-02
PL373496A1 (en) 2005-09-05
US7828787B2 (en) 2010-11-09

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