EP0812158A1 - Poche de perfusion avec orifice d'injection - Google Patents

Poche de perfusion avec orifice d'injection

Info

Publication number
EP0812158A1
EP0812158A1 EP96910333A EP96910333A EP0812158A1 EP 0812158 A1 EP0812158 A1 EP 0812158A1 EP 96910333 A EP96910333 A EP 96910333A EP 96910333 A EP96910333 A EP 96910333A EP 0812158 A1 EP0812158 A1 EP 0812158A1
Authority
EP
European Patent Office
Prior art keywords
infusion
infusion bag
injection port
separator layer
plug
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Withdrawn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
EP96910333A
Other languages
German (de)
English (en)
Other versions
EP0812158A4 (fr
Inventor
Eli Shemesh
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.)
Migada Inc
Original Assignee
Migada Inc
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 Migada Inc filed Critical Migada Inc
Publication of EP0812158A1 publication Critical patent/EP0812158A1/fr
Publication of EP0812158A4 publication Critical patent/EP0812158A4/fr
Withdrawn legal-status Critical Current

Links

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
    • A61J1/05—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

Definitions

  • the present invention relates to infusion bags for administering infusion liquids to subjects, and paiticulaily to an infusion bag including a novel injection port construction for injecting a substance into the infusion bag.
  • Blunt cannulas are now coming into increasing use in place of hypodermic needles in order to reduce the danger of infection by accidental contact with a contaminated needle.
  • blunt cannula constructions the device to be penetrated is closed by an elastomeric plug which is preformed with a slit to accommodate the blunt cannula, but which reseals itself after the blunt cannula has been removed.
  • An object of the present invention is to provide a novel infusion bag having advantages in the above respects.
  • an infusion bag having an injection port for injecting a substance into an infusion liquid in the infusion bag, characterized in that: said injection port is closed by an elastomeric plug which is preformed with a slit for receiving a blunt cannula therethrough to inject said substance into said infusion bag, and which reseals itself after the blunt cannula has been removed: and in that said injection port further includes a separator layer on the inner face of the elastomeric plug, the separator layer being made of a material and of a thickness to be pierceable by a blunt cannula. but when not pierced, to prevent the infusion liquid from reaching and penetrating the slit during autoclaving of the infusion bag to sterilize the infusion liquid therein.
  • the separator layer is preferably of polyethylene, po-yvinyl chloride, nyion or polypropylene: and is preferably of a thickness of 0.05 to 0.30 mm.
  • the injection port is of a tubular configuration joined at its inner end to the infusion bag and formed at its outer end with an internal annular shoulder receiving the separator layer and the elastomeric plug thereover.
  • the injection port further includes a cap applied over the outer end of the infusion port to retain the elastomeric plug and separator layer.
  • the cap is formed with a central opening aligned with the slit to permit a blunt cannula to be inserted into the plug via the slit for injecting a substance into the infusion bag.
  • the central opening in the cap is bordered by inwardly tapering sides of the cap to guide the blunt cannula to the slit.
  • the outer end of the injection port is integrally formed with an intumed annular rim engaging the peripheral outer face of the elastomeric plug for retaining the plug and the separator layer.
  • the infusion bag further includes a removable, tamper-proof foil applied over the outer face of the plug.
  • an infusion bag constructed with the separator layer prevents the infusion liquid within the bag from reaching the elastomeric plug, and particularly from penetrating the slit, when the infusion bag is autoclaved to sterilize the infusion liquid.
  • Such a construction thereby maintains the sterility of the infusion liquid, and the integrity of the elastomeric plug and slit, for the long shelf life required for such infusion bags.
  • Fig. 1 illustrates one form of infusion bag constructed in accordance with the present invention
  • Fig. 2 is an enlarged sectional view illustrating the construction of the injection port in the infusion bag of Fig. 1;
  • Fig. 3 is an enlarged sectional view illustrating another construction of the injection port which may be used in the infusion bag of Fig. 1.
  • the infusion bag illustrated in Fig. 1, and therein generally designated 2 is made of a pliable, transparent plastic material for receiving an infusion liquid, such as saline water.
  • the bag is formed at one end with an opening 4 for suspending the bag at the time of administering the infusion liquid to a subject.
  • the opposite end of the bag includes a tube defining an infusion port 6 for connection to an infusion tubing assembly through which the infusion liquid within the bag is administered to the subject.
  • the infusion bag 2 further includes another tube 8 defining an injection port, generally designated 10, for injecting a substance into the infusion liquid within the bag, if so desired, before the infusion liquid is administered to the subject.
  • the injection port 10 In the conventional infusion bag constructions, the injection port 10, sometimes called the injection site, is closed by an elastomeric plug or membrane pierced by a hypodermic needle at the time of injecting the substance into the bag.
  • the injection port 10 In the construction illustrated in the drawings, the injection port 10 is closed by a pre-slitted elastomeric plug for receiving a blunt cannula to inject the substance into the infusion bag, to thereby reduce the danger of accidental infection by inadvertent contact with a contaminated hypodermic needle.
  • Figs. 2 and 3 illustrate two constructions of the injection port 10 to solve this problem.
  • the injection port 10 illustrated in Fig. 2 is applied to the outer end of tube 8 joined at its inner end to the infusion bag.
  • Injection port 10 is formed at its outer end with an internal annular shoulder 11.
  • Received on annular shoulder 11 are a separator layer 12, and thereover an elastomeric plug 13, such as of a rubber latex.
  • Plug 13 is preformed with a slit 1-1- for receiving a blunt cannula (not shown) used to inject a substance into the infusion bag prior to administering the infusion liquid.
  • Slit 14 may extend only partly through plug 13. e.g., terminating just short of its lower face, such that the slitted and unslitted parts are penetrated by the blunt cannula when inserted into the plug.
  • slit 14 is formed completely through plug 13 to facilitate the insertion of the blunt cannula through the plug.
  • Cap 15 is formed with a central opening 16 to permit a blunt cannula (not shown) to be inserted into and through plug 13 via its slit 14 for injecting a substance into the solution bag before the solution therein is administered to the subject. Opening 16 in the cap is bordered by inwardly tapering sides 17 of the cap to guide the blunt cannula to the slit 14.
  • An annular seal 18 is provided between the inner surface of cap 15 and the outer surface of the outer end of the injection port 10.
  • a removable tamper-proof foil 19 is applied over the outer face of cap 15.
  • Separator 12 is made of a material and of a thickness which prevent the infusion liquid from reaching and penetrating the preformed slit 14 when the infusion bag is autoclaved at a high temperature (e.g., about 130 C) to sterilize the infusion liquid, but which enable the separator to be easily pierced by a blunt cannula if and when a substance is to be injected into the bag via the injection port.
  • a particularly suitable material for this purpose is polyethylene of a thickness of 0.15 mm.
  • Other materials that may be used are polyvinyl chloride, nylon and polypropylene. Generally, it is preferred to have this separator of a thickness of 0.05 to 0.30 mm.
  • the separator layer 12 thus isolates the elastomeric plug 13 from the contents of the infusion bag, and therefore permits the infusion bag to be sterilized by autoclaving without danger that the steam produced during the process will reach the elastomeric plug, its preformed slit 14, or the infusion liquid within the bag.
  • the separator layer therefore also maintains the integrity of the elastomeric plug and the slit for a long period of time after sterilization, and thereby maintains the sterile condition of the contents of the infusion bag, for the long shelf life, usually about two years, required for such infusion bags.
  • the tamper-proof foil 19 further protects the plug and the contents of the infusion bag.
  • Fig. 3 illustrates an alternative construction that may be used for the injection port, therein generally designated 20.
  • the infusion port in Fig. 3 is also formed at its outer end with an internal annular shoulder 21 for receiving thereon the separator 22 and also the elastomeric plug 23, the latter being preformed with a slit 24 as described above with respect to Fig. 2.
  • the separator layer and elastomeric plug are retained by an inturned annular rim 25 integrally formed at the outer end of the tubular injection port 20 and engaging the outer peripheral face of the elastomeric plug 23.
  • Such a rim is
  • a removable, tamper-proof foil 29 is applied over the outer face of the retainer rim 25 of the elastomeric plug 23.
  • Fig. 3 The construction illustrated in Fig. 3 is otherwise the same, and provides the same advantages, as described above with respect to Fig. 2. While the invention has been described with respect to two preferred embodiments, it will be appreciated that these are set forth merely for purposes of example, and that many other variations, modifications and applications of the invention may be made.

Landscapes

  • Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Hematology (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)

Abstract

L'invention a pour objet une poche de perfusion. Ce sac comporte un orifice d'injection (10) pour injecter une substance dans un liquide contenu dans la poche. L'orifice d'injection est fermé par un bouchon en élastomère (13) qui est préformé avec une fente (14) pour recevoir une canule épointée afin d'injecter la substance dans la poche. L'orifice se referme de lui-même une fois la canule retirée. En outre, cet orifice comporte une couche de séparation (12) sur la face intérieure du bouchon d'élastomère, dont le matériau et l'épaisseur permettent son perçage par une canule. Toutefois, tant que la couche n'est pas percée, elle empêche le liquide d'atteindre et de pénétrer dans la fente lors du traitement en autoclave du sac de perfusion pour stériliser le liquide à injecter.
EP96910333A 1995-02-27 1996-02-26 Poche de perfusion avec orifice d'injection Withdrawn EP0812158A4 (fr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
IL11281695 1995-02-27
IL11281695A IL112816A0 (en) 1995-02-27 1995-02-27 Infusion bag with injection port
PCT/US1996/002580 WO1996026681A1 (fr) 1995-02-27 1996-02-26 Poche de perfusion avec orifice d'injection

Publications (2)

Publication Number Publication Date
EP0812158A1 true EP0812158A1 (fr) 1997-12-17
EP0812158A4 EP0812158A4 (fr) 1998-05-13

Family

ID=11067140

Family Applications (1)

Application Number Title Priority Date Filing Date
EP96910333A Withdrawn EP0812158A4 (fr) 1995-02-27 1996-02-26 Poche de perfusion avec orifice d'injection

Country Status (4)

Country Link
EP (1) EP0812158A4 (fr)
AU (1) AU5355896A (fr)
IL (1) IL112816A0 (fr)
WO (1) WO1996026681A1 (fr)

Families Citing this family (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6162206A (en) * 1997-12-23 2000-12-19 Baxter International Inc. Resealable access site
US6186997B1 (en) * 1998-01-20 2001-02-13 Bracco Research Usa Multiple use universal connector
CA2262477C (fr) * 1998-05-16 2008-02-12 Bracco International B.V. Fermeture polyvalente universelle
EP1384466A1 (fr) * 2002-07-23 2004-01-28 Fresenius Kabi Deutschland GmbH Bouteille de plastique destinée à recevoir un fluide, notamment une solution de nutrition entérale
KR200443795Y1 (ko) * 2007-07-13 2009-03-23 주식회사 메디펙 넌 피브이씨 재질의 수액백용 포트
US8864725B2 (en) 2009-03-17 2014-10-21 Baxter Corporation Englewood Hazardous drug handling system, apparatus and method
FR2945293B1 (fr) 2009-05-11 2011-06-17 Teoxane Procede de preparation d'un gel reticule.
CA3163336A1 (fr) * 2019-12-12 2021-06-17 Fresenius Medical Care Holdings, Inc. Orifice d'injection destine au raccordement a un recipient de fluide medical et ses procedes de production

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4119128A (en) * 1977-02-18 1978-10-10 Marilyn Bishop Tamperproof sterile port cover and method of making same
US4307766A (en) * 1979-05-18 1981-12-29 Terumo Corporation Plastic container for medical liquid
WO1994022524A2 (fr) * 1993-04-01 1994-10-13 Migada Inc. Dispositif de raccordement pour fluide et dispositif a canule mousse utilise notamment avec celui-ci
WO1995017873A1 (fr) * 1993-12-28 1995-07-06 Abbott Laboratories Element pour refermer d'une maniere etanche un orifice a fluide

Family Cites Families (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4592092A (en) * 1982-01-20 1986-05-27 American Hospital Supply Corporation Medical solution container and port construction therefor
GB8300475D0 (en) * 1983-01-08 1983-02-09 Boots Co Plc Container
US5211638A (en) * 1988-01-25 1993-05-18 Baxter International Inc. Pre-slit injection site
US5188628A (en) * 1990-11-06 1993-02-23 Sandoz Ltd. Closure device for enteral fluid containers

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4119128A (en) * 1977-02-18 1978-10-10 Marilyn Bishop Tamperproof sterile port cover and method of making same
US4307766A (en) * 1979-05-18 1981-12-29 Terumo Corporation Plastic container for medical liquid
WO1994022524A2 (fr) * 1993-04-01 1994-10-13 Migada Inc. Dispositif de raccordement pour fluide et dispositif a canule mousse utilise notamment avec celui-ci
WO1995017873A1 (fr) * 1993-12-28 1995-07-06 Abbott Laboratories Element pour refermer d'une maniere etanche un orifice a fluide

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See also references of WO9626681A1 *

Also Published As

Publication number Publication date
WO1996026681A1 (fr) 1996-09-06
AU5355896A (en) 1996-09-18
EP0812158A4 (fr) 1998-05-13
IL112816A0 (en) 1995-05-26

Similar Documents

Publication Publication Date Title
US5454805A (en) Medicine vial link for needleless syringes
JP3694317B2 (ja) ポートアダプター及びプロテクター並びにこれらを有する容器
US9108031B2 (en) Connector having a membrane, for connecting a syringe to a container or tubing
US5100394A (en) Pre-slit injection site
US5620434A (en) Medicine vial link for needleless syringes
US5211638A (en) Pre-slit injection site
JP3852672B2 (ja) 容器用キャップ及び液体連通用アダプタ
US5776125A (en) Needleless vial access device
US5135489A (en) Pre-slit injection site and tapered cannula
CA1099230A (fr) Traduction non-disponible
US20090270832A1 (en) Needleless port assembly for a container
CA2071280A1 (fr) Adaptateurs de transfert
KR980008252A (ko) 시린지 충전 및 운반 장치
EP0812158A1 (fr) Poche de perfusion avec orifice d'injection
EP0820779B1 (fr) Dispositif pour remplir et administrer le contenu de seringues
JP2006212084A (ja) コネクタ
JP2000126274A (ja) 薬剤混合システムおよび薬剤収納容器
JPH0626586B2 (ja) 混注部付き接続部品
JP3949125B2 (ja) マルチ針付きホルダー
JP2001178831A (ja) 薬液容器用接続器具及び接続用具
CA2094329A1 (fr) Adapteur de debit pour ampoule de medicaments

Legal Events

Date Code Title Description
PUAI Public reference made under article 153(3) epc to a published international application that has entered the european phase

Free format text: ORIGINAL CODE: 0009012

17P Request for examination filed

Effective date: 19970822

AK Designated contracting states

Kind code of ref document: A1

Designated state(s): DE FR GB IT NL

A4 Supplementary search report drawn up and despatched

Effective date: 19980326

AK Designated contracting states

Kind code of ref document: A4

Designated state(s): DE FR GB IT NL

STAA Information on the status of an ep patent application or granted ep patent

Free format text: STATUS: THE APPLICATION IS DEEMED TO BE WITHDRAWN

18D Application deemed to be withdrawn

Effective date: 19970828