EP1235540A2 - Systeme de prelevement et d'addition par injection pour solutions medicales et contenant pourvu d'un tel systeme de prelevement et d'addition par injection - Google Patents

Systeme de prelevement et d'addition par injection pour solutions medicales et contenant pourvu d'un tel systeme de prelevement et d'addition par injection

Info

Publication number
EP1235540A2
EP1235540A2 EP00991587A EP00991587A EP1235540A2 EP 1235540 A2 EP1235540 A2 EP 1235540A2 EP 00991587 A EP00991587 A EP 00991587A EP 00991587 A EP00991587 A EP 00991587A EP 1235540 A2 EP1235540 A2 EP 1235540A2
Authority
EP
European Patent Office
Prior art keywords
removal
injection
injection system
container
base part
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
EP00991587A
Other languages
German (de)
English (en)
Other versions
EP1235540B1 (fr
Inventor
Reinhold Herbert
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
Publication of EP1235540A2 publication Critical patent/EP1235540A2/fr
Application granted granted Critical
Publication of EP1235540B1 publication Critical patent/EP1235540B1/fr
Anticipated expiration legal-status Critical
Expired - Lifetime 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
    • A61J1/05—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 invention relates to a removal and injection system for medical solutions, in particular for infusion solution bags, which has a base part which can be welded into the bag and has a removal and injection part. Furthermore, the invention relates to a container, in particular an infusion solution bag with such a removal and injection system.
  • Medical solutions in particular infusion solutions, are generally provided in plastic bags.
  • Carrier systems for example injection molded parts, hoses or the like, are sealed into the bag film and in turn the actual connection systems, e.g. B. connectors, septa or the like, record.
  • Extraction and injection systems which have an extraction part closed with a membrane and an injection part. To remove the solution, the removal part is pierced by a spike to which a hose line is connected. The injection part allows another solution to be injected with an injection syringe.
  • EP 0 732 114 A 1 and DE 24 58 220 A 1 describe removal and injection systems for bags containing enteral nutrient solutions, which are relatively complex screw closures.
  • DE 33 05 365 C2 describes a removal and injection system for a film bag, which consists of a base part and a removal and injection part.
  • the base part is designed in the manner of a boat and, as a removal and injection part, takes up two short pieces of hose which protrude beyond the base part or can be flush with it.
  • the extraction and injection systems which are designed like a boat, have proven themselves in practice. However, their relatively complex manufacture is disadvantageous.
  • the invention has for its object to provide a removal and injection system for medical solutions that can be produced inexpensively in large quantities from as few parts as possible, simply inserted into the container and on the other hand easy to handle. Another object of the invention is to provide a container for medical solutions with such a removal and injection system.
  • the removal and injection part are connected to one another with a flat web.
  • the flat design of the base part with the integrated removal and injection point not only saves material, but also simplifies production.
  • the removal and injection system is particularly intended for installation in a foil bag.
  • the flat web is bulged to form a closable opening.
  • the opening in the web serves both to fill the container and to simplify its handling during the manufacturing process.
  • a fixing dome can be inserted into the opening for transport or for correct positioning and rotation.
  • the container can be filled through the opening by means of a filling dome.
  • the fixation and filling can also follow by means of a common dome, which is inserted into the opening, which makes handling even easier. After filling the container, the opening is simply closed by compressing and welding the web.
  • the system has both an extraction and an injection part. Several removal and / or injection parts are also possible.
  • the base part represents a connector part, which allows connection systems of different training to be built or installed. Since all connection systems are based on the same base part, the machine-side parts for transport and fixing can remain unchanged, so that a simple and quick change is possible. The filling and closing process is always the same regardless of the type of dispensing and injection system.
  • the opening in the web preferably has a cross section which tapers in the direction of the removal and injection part. Since the opening is not circular, the dome can be held clamped in the opening. In addition, the web in the area of the bulge-like expansion can be pressed together particularly easily due to this shape and welded to form a flat connecting piece.
  • the removal, injection part and web are preferably an integral part of the base part.
  • the base part is preferably an injection molded part made of polyolefin or thermoplastic elastomer (TPE).
  • the base part should consist of a material that cannot be sealed with the bag film
  • the base part is at least partially covered with a sealable layer, in particular a plastic layer that can be welded to the known polyolefin films of the bag, which is based on PP or PE .
  • a sealable layer in particular a plastic layer that can be welded to the known polyolefin films of the bag, which is based on PP or PE .
  • the base part is preferably provided on the outside with ribs with which the film is sealed.
  • the membrane closing the removal and / or injection part is preferably arranged in the base part.
  • it can consist of a plastic plate, which is also in one piece with the base part.
  • a pierceable septum is preferably arranged above the membrane, which permits permanent closure even after the membrane has been pierced with an injection cannula.
  • the membrane covering the septum can also be omitted, and the membrane itself can also represent the septum.
  • the removal and / or injection part are essentially flush with the outside of the base part. This means that there are no protruding connecting parts with the exception of tapping points, covers or the like. This results in a short overall length, which also further reduces the dimensions and the amount of material required for production.
  • the base part can be designed differently, so that the geometry can be optimized for the respective application.
  • the removal and / or injection part have an essentially hollow cylindrical section which is integral with the base part.
  • a tubular cover closes on the base part in the region of the removal and / or injection part that extends inwards.
  • the cover extending into the inside of the bag not only has a protective function, but also can also be used to guide the spike or cannula.
  • the cover does not have to enclose the extraction and / or injection channel on all sides. It is sufficient to cover the channel only on the sides where there is a risk of puncturing the bag film.
  • the cover of the removal part is a piece of pipe slotted in the longitudinal direction.
  • the slot or slots in the longitudinal direction allow the bag to be completely emptied.
  • bores or the like can also be provided in the cover.
  • the removal and / or injection part are closed with a tear-off film for sterile covering of the membrane and as tamper-evident device. Since the removal and / or injection part is preferably essentially flush with the base part, the tear-off film can be part of the bag film. However, additional tear-off films or twist-off covers can also be provided.
  • Fig. 1 shows an embodiment of the removal and injection system in a sectional view.
  • Fig. 2 shows the removal and injection system of Figure 1 from the view of
  • FIG. 3 shows a section through the removal and injection system of Figure 1 along the line III-III
  • Fig. 4 shows a side view of the removal and injection system
  • Fig. 5 shows a foil bag with a removal and injection system
  • Fig. 6a the base part of two further embodiments of the dispensing and 6b injection system in the top and side view
  • Fig. 7 shows an embodiment of the removal and injection system with the base part of Figures 6a and 6b in side view
  • FIGS. 6a and 6b shows a side view of a further exemplary embodiment of the removal and injection system with the base part from FIGS. 6a and 6b.
  • Figure 1 shows a longitudinal section through the removal and injection system, while in Figure 2, the removal and injection system is shown in plan view.
  • the removal and injection system 1 is a one-piece injection molded part, in particular made of a thermoplastic elastomer (TPE). It has a base part 2 designed in the manner of a boat, which is sealed with the film of a film bag.
  • the base part 2 comprises a removal part 3 and an injection part 4, which are connected to one another by a flat web 35.
  • the base part 2 welded into the bag has an outside 5 and an inside 6 and two longitudinal sides 7, 8 sealed with the bag film.
  • the base part 1 tapers at its ends, the base part 2 having a width in the region of the removal part 3 and the injection part 4 which corresponds to the diameter of the removal and injection part (FIG. 2).
  • the removal and injection part are essentially flush with the outside 5 of the base part. They are each formed by a channel 9, 10 in the base part 2.
  • the channel 9 of the removal part 3 has a diameter which corresponds to that of the spike of the transfer hose (not shown) for removing the liquid, while the diameter of the channel 10 of the injection part 4 is smaller.
  • the channels 9, 10 are sterile closed by a pierceable plastic membrane 11, 12, which is integral with the base part 2.
  • a permanent septum 13 is inserted in the channel 10 above the membrane 12 for permanent sealing of the injection part.
  • the base part 2 On its outside 5, the base part 2 has an annular extension 14 which surrounds the opening of the channel 9 and an annular extension 15 which surrounds the opening of the channel 10.
  • the annular projections 14, 15 serve to better guide the spike or the injection cannula.
  • a pipe section 16, 17 adjoins the channel 9 of the removal part 3 and the channel 10 of the injection part 4 on the inside 6 of the base part 2. At least the pipe section 16 of the removal part has two slots 18, 19 which lie in the plane of the base part 2 (FIG. 3). If the membrane 11 of the removal part 3 is pierced by the spike, the tube piece 16 serves on the one hand as a guide for the spike and on the other hand as a cover, which prevents the foil bag from being pierced. The bag can be completely emptied via the lateral slots 18, 19 in the pipe section 16 of the removal part.
  • the pipe section 17 of the injection part 4 also serves primarily to protect the bag film.
  • the flat web 35 is expanded like a bead, forming an opening 34.
  • the opening 34 has a cross section which tapers towards the removal and injection part, so that the two side edges 36, 37 of the web can be compressed slightly in the region of the opening.
  • the opening 34 serves on the one hand for filling and on the other hand for fixing the bag.
  • a fixing dome is inserted into the opening, which does not have a circular shape but tapers at the ends, and is held clampingly between the side edges 36, 37. This allows the bag to be transported and positioned in the correct position and secure against rotation.
  • the bag is filled via a filling dome, which is also inserted into the opening 35.
  • a filling dome which is also inserted into the opening 35.
  • the two outer walls 36, 37 which have a high degree of flexibility, are pressed tightly together welded together.
  • the base part can be fixed with the same dome as the filling of the bag.
  • the base part 2 has a plurality of transverse webs 38 on both outer sides, which are sealed with the bag film.
  • Fig. 4 shows a side view of the base part with the webs.
  • FIG. 5 shows a film bag with a removal and injection system which is welded into a film bag.
  • the base part 20 is designed as a flat web which tapers at its ends, while the removal part 21 and the injection part 22 each have a hollow cylindrical section 23, 24 of different diameters, which is integral with the base part.
  • the hollow cylindrical sections 23, 24 are flush with the outside 25 of the base part.
  • the hollow cylindrical sections 23, 24 merge into tubular covers 27, 28, with at least the cover of the removal part being slit laterally in the longitudinal direction. These are only shown in broken lines in FIG. 4.
  • the filling and fixing opening 34 has been closed by compressing the web connecting the removal and injection part in the region of the bulge-like expansion and welding of the two outer walls, so that the web is flat over its entire length between the removal and injection part.
  • the film bag 29, which can be filled with an infusion solution, consists of two superposed plastic films 30, 31 welded together at their edges, which are sealed to the long sides of the base part 20.
  • the lower pouch film 31 has on its upper edge protruding tabs 32, 33 which extend over the openings of the removal and injection part 21, 22 and are sealed to the outside 25 of the base part. To remove or inject liquids, the tabs 32, 33 are torn off, so that the filling or removal opening is exposed.
  • the removal and injection system consists of a material that cannot be sealed with the bag film
  • at least the base part is coated on its long sides with a layer, in particular a PP-based plastic layer, with which the bag film, for example a polyolefin film, can be sealed ,
  • FIGS. 7 and 8 show a side view of two further exemplary embodiments of the removal and injection system, which are based on the base part from FIGS. 6a and 6b.
  • the base part differs from the base part of the embodiment of the removal and injection system described with reference to FIGS. 1 to 4 essentially by the dimensions of the removal and injection opening 9, 10, which have the same diameter.
  • the corresponding parts are provided with the same reference numerals.
  • the exemplary embodiment according to FIG. 7 has two add-on parts which lie on the inside of the base part 2 lying on the container.
  • the removal and injection part 3, 4 each pass into a pipe section 39, 40, which have a different length.
  • Both pipe sections 39, 40 are each provided with a lateral opening 41, 42 in order to be able to completely empty the container.
  • FIG. 8 differs from the embodiment of FIG. 7 in that the attachments are on the outside of the base part 2 facing away from the container.
  • the removal part 3 merges into a connector 43 which is closed with a break-off part 44.
  • a short piece of pipe 45 adjoins the injection part 4 and is closed with a septum 46.

Landscapes

  • Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Hematology (AREA)
  • Veterinary Medicine (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
  • Bag Frames (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • External Artificial Organs (AREA)
  • Sampling And Sample Adjustment (AREA)

Abstract

L'invention concerne un système de prélèvement et d'addition par injection pour contenants à solutions médicales, en particulier des poches en film. Ledit système de prélèvement et d'addition par injection comporte une partie de base (2) pouvant être soudée dans la poche et pourvue d'une partie de prélèvement et d'addition par injection (3, 4), ces deux parties étant reliées par une pièce jointive (35) plate. Entre la partie de prélèvement et d'addition par injection, la partie jointive plate s'élargit en constituant un bourrelet et en formant une ouverture pouvant être fermée. L'ouverture formée par la pièce jointive sert aussi bien au remplissage du contenant au moyen d'une douille de remplissage qu'à son transport et à son positionnement au moyen d'une douille de fixation. L'invention concerne également un contenant, en particulier une poche, comprenant un tel système de prélèvement et d'addition par injection.
EP00991587A 1999-12-08 2000-12-07 Systeme de prelevement et d'addition par injection pour solutions medicales et contenant pourvu d'un tel systeme de prelevement et d'addition par injection Expired - Lifetime EP1235540B1 (fr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
DE19958952 1999-12-08
DE19958952A DE19958952B4 (de) 1999-12-08 1999-12-08 Entnahmesystem für medizinische Lösungen und Behälter mit einem derartigen Entnahmesystem
PCT/EP2000/012344 WO2001041698A2 (fr) 1999-12-08 2000-12-07 Systeme de prelevement et d'addition par injection pour solutions medicales et contenant pourvu d'un tel systeme de prelevement et d'addition par injection

Publications (2)

Publication Number Publication Date
EP1235540A2 true EP1235540A2 (fr) 2002-09-04
EP1235540B1 EP1235540B1 (fr) 2003-08-13

Family

ID=7931709

Family Applications (1)

Application Number Title Priority Date Filing Date
EP00991587A Expired - Lifetime EP1235540B1 (fr) 1999-12-08 2000-12-07 Systeme de prelevement et d'addition par injection pour solutions medicales et contenant pourvu d'un tel systeme de prelevement et d'addition par injection

Country Status (25)

Country Link
US (1) US20030075469A1 (fr)
EP (1) EP1235540B1 (fr)
JP (1) JP2003516186A (fr)
KR (1) KR100781448B1 (fr)
CN (1) CN1189146C (fr)
AT (1) ATE246913T1 (fr)
AU (1) AU781617B2 (fr)
BR (1) BR0016222A (fr)
CA (1) CA2393572C (fr)
CZ (1) CZ20021863A3 (fr)
DE (2) DE19958952B4 (fr)
DK (1) DK1235540T3 (fr)
ES (1) ES2199895T3 (fr)
HR (1) HRP20020504A2 (fr)
HU (1) HUP0204440A2 (fr)
IL (1) IL149900A0 (fr)
MX (1) MXPA02005674A (fr)
NO (1) NO20022677L (fr)
NZ (1) NZ519201A (fr)
PL (1) PL355527A1 (fr)
PT (1) PT1235540E (fr)
RS (1) RS49731B (fr)
SK (1) SK7722002A3 (fr)
WO (1) WO2001041698A2 (fr)
ZA (1) ZA200204583B (fr)

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DE102004051300C5 (de) * 2004-10-20 2013-01-24 Fresenius Kabi Deutschland Gmbh Verschlusskappe für mit medizinischen Flüssigkeiten befüllte Behältnisse
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DE102006004611B4 (de) * 2006-02-01 2009-06-18 Plümat Plate & Lübeck GmbH & Co. Vorrichtung und Verfahren zur Herstellung von Kunststoffbeuteln
CN2915107Y (zh) * 2006-04-19 2007-06-27 湖南千山制药机械股份有限公司 大输液软袋用带配药嘴的硬双口管
JP2008099778A (ja) * 2006-10-18 2008-05-01 Fuji Seal International Inc 医療用パウチ
DE102007005407A1 (de) * 2007-02-03 2008-08-07 Fresenius Kabi Deutschland Gmbh Verschlusskappe für ein Behältnis zur Aufnahme von medizinischen Flüssigkeiten und Behältnis zur Aufnahme von medizinischen Flüssigkeiten
DE102008007252A1 (de) * 2008-02-01 2009-08-13 Plümat Plate & Lübeck GmbH & Co. Verschlusskappe für Behälter
DE102011016767A1 (de) * 2011-04-12 2012-10-18 Sartorius Stedim Biotech Gmbh Verwendung einer Vorrichtung und eines Verfahrens zur Aufbereitung von pharmazeutischen Stoffgemischen
US9005181B2 (en) 2012-03-09 2015-04-14 Fenwal, Inc. Sterile openable access port and containers including the same
US20160051444A1 (en) * 2013-03-24 2016-02-25 Kiefel Gmbh Installation for manufacturing a bag for medical purposes, method for manufacturing such a bag, injection stopper and bag for medical purposes
DE102013012809A1 (de) * 2013-08-01 2015-02-05 Kocher-Plastik Maschinenbau Gmbh Kopfstück für einen mit einem Medium befüllbaren Behälter
PL3294255T3 (pl) * 2015-05-08 2020-07-27 Fresenius Kabi Ab Łącznik do pojemnika medycznego
DE102016012059A1 (de) * 2016-10-08 2018-04-12 Fresenius Kabi Deutschland Gmbh Konnektor für ein eine Flüssigkeit enthaltendes medizinisches Packmittel
EP3461469A1 (fr) * 2017-10-02 2019-04-03 Weibel CDS AG Emballage primaire
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Also Published As

Publication number Publication date
BR0016222A (pt) 2002-09-10
WO2001041698A3 (fr) 2001-12-27
PL355527A1 (en) 2004-05-04
US20030075469A1 (en) 2003-04-24
EP1235540B1 (fr) 2003-08-13
ZA200204583B (en) 2003-11-26
AU3363201A (en) 2001-06-18
DE19958952B4 (de) 2004-05-27
ATE246913T1 (de) 2003-08-15
MXPA02005674A (es) 2002-09-02
CZ20021863A3 (cs) 2003-03-12
HRP20020504A2 (en) 2005-06-30
SK7722002A3 (en) 2003-04-01
HUP0204440A2 (en) 2003-05-28
DK1235540T3 (da) 2003-10-20
DE19958952A1 (de) 2001-06-28
AU781617B2 (en) 2005-06-02
KR100781448B1 (ko) 2007-12-03
RS49731B (sr) 2008-04-04
IL149900A0 (en) 2002-11-10
YU38902A (sh) 2003-08-29
NO20022677D0 (no) 2002-06-06
CA2393572A1 (fr) 2001-06-14
PT1235540E (pt) 2003-11-28
NO20022677L (no) 2002-06-06
NZ519201A (en) 2003-10-31
DE50003318D1 (de) 2003-09-18
CA2393572C (fr) 2008-08-19
WO2001041698A2 (fr) 2001-06-14
CN1189146C (zh) 2005-02-16
KR20020075774A (ko) 2002-10-05
ES2199895T3 (es) 2004-03-01
JP2003516186A (ja) 2003-05-13
CN1407879A (zh) 2003-04-02

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