EP2191807A2 - Raccord pour emballages contenant des liquides médicinaux et emballage pour liquides médicinaux - Google Patents

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

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Publication number
EP2191807A2
EP2191807A2 EP20100002916 EP10002916A EP2191807A2 EP 2191807 A2 EP2191807 A2 EP 2191807A2 EP 20100002916 EP20100002916 EP 20100002916 EP 10002916 A EP10002916 A EP 10002916A EP 2191807 A2 EP2191807 A2 EP 2191807A2
Authority
EP
European Patent Office
Prior art keywords
membrane
connector
plate
spike
shaped
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.)
Granted
Application number
EP20100002916
Other languages
German (de)
English (en)
Other versions
EP2191807B1 (fr
EP2191807A3 (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
Publication of EP2191807A2 publication Critical patent/EP2191807A2/fr
Publication of EP2191807A3 publication Critical patent/EP2191807A3/fr
Application granted granted Critical
Publication of EP2191807B1 publication Critical patent/EP2191807B1/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 self-sealing membrane for a connector for medicinal liquids containing packaging, in particular infusion or transfusion bag, which serves to remove a liquid from the bag.
  • 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 tubular connection part of the known removal part is closed by a flat membrane, which is integral with the connection part.
  • 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 self-sealing membrane for a connector for medicinal liquids containing packaging, in particular infusion or transfusion bag, which seals the packaging safely after pulling out the spike.
  • the membrane of the invention is arranged in a connector 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 . 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 not due to the material volume, but the special geometry of the membrane.
  • the material of the plate-shaped section of the membrane is preferably weakened, so that the membrane can be pierced particularly easily with the spike.
  • 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.
  • the tubular connection part of the connector is composed of a lower and an upper portion, wherein the portions are set snapping.
  • the self-sealing membrane is preferably clamped with elastic deformation thereof between the lower and upper portions. Consequently, the assembly of the connector can be done easily by pressing the items. But it is also possible that the items are welded together and / or glued together.
  • Another particularly preferred embodiment provides that adjoins the annular portion of the membrane, an outer portion which is clamped between the two sections.
  • a second pierceable membrane is preferably disposed to form a space below the self-sealing membrane.
  • the second diaphragm is expediently an integral part of the tubular connecting piece.
  • the spike is held in the eingochenenen position by the arched membrane clamped. As a result, the holding force of the spike is increased in the removal position, whereby accidental slipping is prevented.
  • 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 part, 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 consequently 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 nozzle 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 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 depression 13 on the upper side of the membrane 10.
  • In the center 15 of the plate-shaped portion 14 is pre-slit crosswise or star-shaped, so that although the elastic material is weakened, but not severed.
  • a cap-shaped closure member 16 which closes the upper opening 1 a of the connection part 1.
  • 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 connecting pieces of the tamper-evident closures can, however, also be formed on an insert piece designed in the manner of a shuttle or round, which is welded between the two foil 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 will be with the sealed annular portion 12 of the membrane 10. Due to the special design of the injected membrane 6, the spike is held firmly in the tubular connection part 1.
  • 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.

Landscapes

  • Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Hematology (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Packages (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
  • Bag Frames (AREA)
  • Closures For Containers (AREA)
EP10002916.4A 2002-05-27 2003-02-24 Raccord pour emballages contenant des liquides médicinaux et emballage pour liquides médicinaux Expired - Lifetime EP2191807B1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE2002123560 DE10223560B4 (de) 2002-05-27 2002-05-27 Konnektor für medizinische Flüssigkeiten enthaltende Verpackungen und Verpackung für medizinische Flüssigkeiten
EP20030706563 EP1507502B1 (fr) 2002-05-27 2003-02-24 Raccord pour emballages contenant des liquides medicinaux et emballage pour liquides medicinaux

Related Parent Applications (2)

Application Number Title Priority Date Filing Date
EP20030706563 Division EP1507502B1 (fr) 2002-05-27 2003-02-24 Raccord pour emballages contenant des liquides medicinaux et emballage pour liquides medicinaux
EP03706563.8 Division 2003-02-24

Publications (3)

Publication Number Publication Date
EP2191807A2 true EP2191807A2 (fr) 2010-06-02
EP2191807A3 EP2191807A3 (fr) 2011-06-01
EP2191807B1 EP2191807B1 (fr) 2016-09-07

Family

ID=29557331

Family Applications (2)

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

Family Applications Before (1)

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

Country Status (20)

Country Link
US (2) US7828787B2 (fr)
EP (2) EP1507502B1 (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)
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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FR3005854B1 (fr) 2013-05-22 2015-06-26 Maco Pharma Sa Embase d'un connecteur pour poche de perfusion
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US20160242998A1 (en) * 2013-09-25 2016-08-25 Fresenius Kabi Deutschland Gmbh Food arrangement
SG11201704851TA (en) * 2014-12-18 2017-07-28 Otsuka Pharma Factory Inc Port, and Medical Liquid Bag
PL3294255T3 (pl) * 2015-05-08 2020-07-27 Fresenius Kabi Ab Łącznik do pojemnika medycznego
ES2762926T3 (es) * 2015-05-13 2020-05-26 Fresenius Kabi Deutschland Gmbh Recipiente para un líquido médico
JP2019508326A (ja) * 2016-01-19 2019-03-28 ドクター ピー インスティチュート エルエルシー 取付け具を備えたパウチおよびパウチを作製する方法
ITUA20161560A1 (it) * 2016-03-11 2017-09-11 Luc & Bel S R L Raccordo per un dispositivo medico d'infusione e trasfusione parentale o enterale.
DE102016116098A1 (de) 2016-08-30 2018-03-01 B. Braun Avitum Ag Verschlusskappe für einen kartuschenförmigen Behälter
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KR101875518B1 (ko) * 2017-05-08 2018-07-10 (주)에이디켐테크 개방이 용이한 플라스틱 백
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US20250082622A1 (en) 2023-09-12 2025-03-13 Fresenius Kabi Austria Gmbh Bupivacaine liquid formulations
US12539283B1 (en) 2024-12-06 2026-02-03 Fresenius Kabi Usa, Llc Epinephrine liquid formulations

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NO328168B1 (no) 2009-12-21
DE50312773D1 (de) 2010-07-15
KR100944420B1 (ko) 2010-02-26
PT1507502E (pt) 2010-06-28
ZA200409019B (en) 2007-08-29
HK1081430A1 (zh) 2006-05-19
US8118802B2 (en) 2012-02-21
AU2003208752A1 (en) 2003-12-12
US7828787B2 (en) 2010-11-09
SI1507502T1 (sl) 2010-10-29
JP2005527301A (ja) 2005-09-15
AU2003208752B8 (en) 2008-07-31
BRPI0311342B8 (pt) 2021-06-22
CN1655750A (zh) 2005-08-17
CN100398084C (zh) 2008-07-02
DE10223560B4 (de) 2006-01-19
BR0311342B1 (pt) 2013-12-31
PL373496A1 (en) 2005-09-05
ES2343456T3 (es) 2010-08-02
NO20045169L (no) 2005-02-17
PL212919B1 (pl) 2012-12-31
MXPA04011784A (es) 2005-03-31
AU2003208752B2 (en) 2008-07-10
US20050215943A1 (en) 2005-09-29
BR0311342A (pt) 2005-03-22
IN2012DN01252A (fr) 2015-05-15
CA2487551C (fr) 2014-05-20
US20110022024A1 (en) 2011-01-27
KR20050012753A (ko) 2005-02-02
WO2003099191A1 (fr) 2003-12-04
EP2191807B1 (fr) 2016-09-07
EP1507502A1 (fr) 2005-02-23
CA2487551A1 (fr) 2003-12-04
DE10223560A1 (de) 2003-12-18
ATE469630T1 (de) 2010-06-15
EP1507502B1 (fr) 2010-06-02
EP2191807A3 (fr) 2011-06-01
DK1507502T3 (da) 2010-09-20
JP4526382B2 (ja) 2010-08-18

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