EP0508251B1 - Mischbehälter zum Verbinden einer Spritze und Verfahren - Google Patents

Mischbehälter zum Verbinden einer Spritze und Verfahren Download PDF

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Publication number
EP0508251B1
EP0508251B1 EP19920105411 EP92105411A EP0508251B1 EP 0508251 B1 EP0508251 B1 EP 0508251B1 EP 19920105411 EP19920105411 EP 19920105411 EP 92105411 A EP92105411 A EP 92105411A EP 0508251 B1 EP0508251 B1 EP 0508251B1
Authority
EP
European Patent Office
Prior art keywords
container
tube
solution
connector
luer
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
EP19920105411
Other languages
English (en)
French (fr)
Other versions
EP0508251A1 (de
Inventor
Johannes Von Der Heiden
Hubertus Eduard Hilbrink
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.)
NPBI International BV
Original Assignee
NPBI Nederlands Produktielaboratorium voor Bloedtransfusieapparatuur en Infusievloeistoffen BV
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.)
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Publication date
Application filed by NPBI Nederlands Produktielaboratorium voor Bloedtransfusieapparatuur en Infusievloeistoffen BV filed Critical NPBI Nederlands Produktielaboratorium voor Bloedtransfusieapparatuur en Infusievloeistoffen BV
Publication of EP0508251A1 publication Critical patent/EP0508251A1/de
Application granted granted Critical
Publication of EP0508251B1 publication Critical patent/EP0508251B1/de
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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
    • A61J1/05—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
    • A61J1/05—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

  • Our present invention relates to a method of diluting a drug-containing intravenous solution or for aseptically forming a solution of a drug for intravenous administration and to an apparatus utilizing this method. More particularly, the invention relates to the preparation of intravenous administration solutions without the need for needles for injecting a drug into the liquid vehicle or diluent solution.
  • drugs require reconstitution and/or dilution in an IV (intravenous) solution before they can be administered to patients.
  • IV intravenous
  • These drugs are generally life-saving medicaments that need to be injected directly into the vein of the patient to get the desired pharmacological effect.
  • Dilution in an infusion solution can for instance be necessary to acquire the needed pharmacokinetic profile (i.e. a constant steady state plasma level) or to reduce the potential toxic effect of the drug. This is specially true for cytotoxic drugs, most of which would cause serious damage to the vein if they would be injected without prior dilution.
  • the state of the art in preparing a powdered drug in an intravenous form is to first inject a portion of the diluent into the drug vial. Since the powdered form of the medicament may be in lyophilized form, this step is referred to as a reconstitution.
  • the syringe is filled with the diluent. Then, the needle of the syringe is pierced through the rubber stopper of the drug vial and the diluent is introduced into the vial through the syringe.
  • the solution is drawn back into the syringe and may be injected by the syringe through an additive port in the container in which the intravenous medium has been packaged.
  • reconstitution is generally not required as these drugs are delivered in a solution.
  • the solution can be drawn directly into the syringe and can subsequently be introduced into the intravenous solution via the additive port in the container.
  • the container After reconstitution or dilution, the container is inspected for particulate matter and leakage. If the container leaks, it will be discarded. After labelling and packaging, it is transported to the ward. There, after inspection and after introduction of an administration set, the reconstituted solution is administered to the patient.
  • Spillage, leakage and aerosols may occur during reconstitution, during transport to the ward, during administration to the patient and through waste.
  • the addition of the drug to the infusion solution as this is performed with a needle.
  • This needle cuts through the rubber and PVC membranes of the port of the container.
  • there is generally some leakage This is due to the fact that closure of the rubber membrane is not based on a chemical process, but is purely a physical process. Therefore, upon removal of the needle, small capillaries will remain in the membrane at the place where the needle has cut through the material.
  • capillaries usually contain some fluid, which may contain the drug solution, originating from the outside of the needle.
  • the small capillaries may leak some of this fluid, especially when the pressure in the container is increased due to the volume of drug solution that was added to the IV container. This increased pressure may also lead to the production of aerosols.
  • Another disadvantage associated with the use of needles is the small diameter of the lumen and subsequently the force needed during reconstitution of the drugs. Especially when large volumes of fluid have to be injected, the use of needles is very tiresome for the operator.
  • US-A-4 336 802 (STONE) describes a standard container that is fitted with a tube containing an administration port with a puncturable diaphragm.
  • the container typically contains a concentrated parenteral solution. Solutions are added so that container via a piercing spike that is connected to a second container from which the solution is dispensed. The piercing spike ruptures the membrane and after addition of the solution, the tubing is sealed.
  • the piercing spike on the medicament container is therefore an essential element of the Stone invention.
  • an object of this invention is to provide a method and apparatus for this reconstitution procedure without the use of needles and rubber administration ports.
  • the sealing of the tube involves cutting the seal into two parts, thereby sealing off the tube and disconnecting the syringe from the container.
  • a break-away connector can be provided in a path of the solution between the syringe and the container by integrating it into the female luer connector, providing it along the tube between the female luer connector and the container or providing it at a junction of the tube with the container.
  • a clamp can be provided on the tube to shut-off flow therethrough.
  • a one way check valve can be fitted into the tube to permit flow only toward the container.
  • a cap on the female luer connector can prevent accidental touch contamination thereof.
  • FIG. 1 shows an IV bag fitted with three ports.
  • One port is provided with a filling tube 2, used by the manufacturer to fill the bag with the IV solution 9. This filling tube is sealed after filling.
  • a second port is provided with an administration port 3.
  • the port in this specific drawing is a 'twist-off' administration port. This port can, however, be of any known configuration and is not limited to this special construction.
  • the plug of this port in the drawing can be removed by turning the upper set of side-wings and taking the plug out.
  • the third port is provided with a piece of tubing 4, fitted with a female luer connector 5 with a cap 6 and a break-away connector 7.
  • the tube 4 is made from a sealable plastic material, for example PVC or polyethylene.
  • the length of the tubing should allow for sealing, being at least 2 cm but preferably being as short as possible to keep the dead volume in the tube as small as possible and to prevent packaging problems.
  • a one-way check valve 8 in the tube between the container 1 and the liner connector 5 may be desirable.
  • This valve 8 should block leakage from the container, while allowing the addition of fluids to the container.
  • the valve can, for example, prevent leakage from the tubing when the syringe is disconnected from the IV bag. This could be necessary if the contents of more than one syringe must be added to the IV container.
  • a slide clamp 10 (FIG. 8) could be used to shut off the tube temporarily.
  • FIG. 2 shows an IV bag fitted with two ports.
  • One port is provided with an administration port as in FIG. 1 while the second port is provided with the tubing with the female luer and break-away connector.
  • the bag can be filled with IV fluid either through the first port and be closed with the twist-off or through the second port and be closed with the luer connector during production.
  • Fig. 3 shows an intravenous container with only one port.
  • the bag is filled with IV fluid through the tube.
  • the tube is fitted with the liner connector.
  • Administration of the reconstituted drug solution to the patient can be accomplished by connecting an administration set to the tube of the bag by means of sterile docking, after the drug has been reconstituted and the tube has been sealed.
  • Methods for making sterile connections have been described in several patents. An apparatus for sterile connections is marketed in the United States by the Haemonetics Company.
  • any combination of ports on the bag is permissible as long as the necessary functions of filling, reconstitution, and administration of the fluid can be carried out.
  • the medicament is a dry powder, first it is dissolved as described above by introducing a volume of diluent into the drug container or drug vial with the aid of a syringe and a needle.
  • This diluent can be taken from any IV container or from an ampoule. Also, the diluent can be taken from the container of this invention by connecting a syringe to the liner connector, breaking the break-away connector and taking the fluid from the container. Before disconnecting the syringe, the tube can be shut off temporarily with a clamp.
  • the drug solution is drawn into the syringe, if necessary with the aid of a needle. Then, the syringe is coupled directly with its male luer connector to the female luer connector of the IV container. The needle is discarded. After breaking of the break-away connector the solution of the drug is introduced into the infusion solution and thoroughly mixed.
  • the tube After mixing, the tube is sealed. Depending on the material of the tube, one of several techniques can be chosen for sealing the tube, for example heat sealing or RF welding. This sealing can be done with a standard apparatus such as marketed by the Sebra Company in the United States.
  • the seal can then be cut in the middle. Part of the original tube remains attached to the infusion container with the reconstituted solution, while the other part stays attached to the female luer and the syringe. After cutting the seal in two halves, both ends are closed. The part with the syringe can be discarded.
  • the tubing is not sealed.
  • the syringe remains firmly attached to the infusion container during transport to the ward and during administration of the IV solution to the patient.
  • this tube can also be used for the administration of the fluid to the patient by connecting an administration set to that tube via a sterile connection technique, as already mentioned before.
  • the administration set can be a standard set and may contain a drip-chamber etc., or may be a simple tube for piggy-backing the solution on a standard IV administration set.
  • the method allows for direct coupling of the syringe and the IV container, it is fast and convenient and safe. As no needles are used, less pressure is needed to inject the soluted drug in the IV container which allows for faster and easier reconstitution. Also, the containers can not be punctured accidentally, which happens frequently with flexible containers during reconstitution with needles. Needle pricks of personnel are eliminated.
  • the IV solution cannot be contaminated with rubber particles due to coring of the membrane.
  • FIG. 9 I have shown the assembly with the syringe as attached by its luer connector 11, namely, a male luer connector, to the female luer connector 5 of any of the bags of FIGS. 1 - 3.
  • the solution from the syringe has, however, been injected into the bag in this illustration so that the body 12 of the syringe and its plunger 13 are also visible.

Landscapes

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

Claims (9)

  1. Methode zur aseptischen Herstellung einer Lösung eines Medikaments zur intravenösen Verabreichung mit Hilfe eines flexiblen Kunststoffbeutels (1), der eine sterile, intravenös zu verabreichende Flüssigkeit enthält, wobei eine Lösung eines intravenös zu verabreichenden Medikaments in diese besagte Flüssigkeit gegeben wird;
    gekennzeichnet durch einen flexiblen Kunststoffbeutel (1) mit einem weiblichen Luer-Anschluß oder Luer-Lock-Anschluß (5), der mit Hilfe eines siegelfähigen Schlauchs (4) mit dem Beutel verbunden wird;
    gekennzeichnet durch eine Spritze mit einer Lösung eines intravenös zu verabreichenden Medikaments, die mit dem besagten Schlauch (4) dadurch verbunden wird, daß der männliche Teil des Luer-Anschlusses in den weiblichen Teil des Luer- oder Luer-Lock-Anschlusses (5) gesteckt wird;
    dadurch gekennzeichnet, daß die besagte Lösung durch Einspritzen mit Hilfe der besagten Spritze in die besagte Flüssigkeit injiziert wird, während der männliche und der weibliche (5) Teil des Luer-Anschlusses fest miteinander verbunden sind; und
    dadurch gekennzeichnet, daß besagter Schlauch zwischen besagter Spritze und besagtem Behälter (1) mit einer Siegelnaht (4a) ausgestattet wird und diese Siegelnaht in zwei Hälften geschnitten wird, wobei der besagte Schlauch (4) versiegelt und die besagte Spritze vom Behälter (1) getrennt wird.
  2. Vorrichtung entsprechend der in Anspruch 1 beschriebenen Methode zur Verabreichung einer aseptischen intravenösen Lösung eines Medikaments, bestehend aus einem flexiblen Kunststoffbehälter (1) mit einer sterilen, intravenös zu verabreichenden Flüssigkeit, gekennzeichnet durch:
    einen siegelfähigen Schlauch (4), der an den besagten Behälter (1) angeschlossen ist; und
    einen weiblichen Luer-Anschluß (5) im besagten Schlauch (4), der direkt auf eine Spritze mit einer intravenös zu verabreichenden Medikamentenlösung gesteckt wird, in dem der männliche, auf der besagten Spritze befindliche Teil des Luer-Anschlusses mit dem besagten weiblichen Luer-Anschluß bzw. Luer-Lock-Anschluß (5) verbunden wird.
  3. Vorrichtung nach Anspruch 2, gekennzeichnet durch einen Abbrech-Konnektor (7) im Strömungsweg der besagten Lösung, positioniert zwischen besagter Spritze und besagtem Behälter (1).
  4. Vorrichtung nach Anspruch 3, dadurch gekennzeichnet, daß der besagte Abbrech-Konnektor (7) und der besagte weibliche Luer-Anschluß bzw. Luer-Lock-Anschluß (5) eine Einheit bilden.
  5. Vorrichtung nach Anspruch 3, dadurch gekennzeichnet, daß der besagte Abbrech-Konnektor (7) innerhalb des besagten Schlauchs (4) zwischen dem besagten weiblichen Luer-Anschluß bzw. Luer-Lock-Anschluß (5) und dem besagten Beutel (1) positioniert ist.
  6. Vorrichtung nach Anspruch 3, dadurch gekennzeichnet, daß der besagte Abbrech-Konnektor (7) an der Übergangsstelle zwischen dem besagten Schlauch (4) und dem besagten Beutel (1) positioniert ist.
  7. Vorrichtung nach Anspruch 2, gekennzeichnet durch eine Klemme (10) am besagten Schlauch (4) zum Sperren des Volumenstroms durch den Schlauch.
  8. Vorrichtung nach Anspruch 2, gekennzeichnet durch ein Rückschlagventil (8) im besagten Schlauch (4), das dafür sorgt, daß durch den Schlauch (4) nur in Richtung des Beutels (1) Flüssigkeit fließen kann.
  9. Vorrichtung nach einem beliebigen der vorgenannten Ansprüche, gekennzeichnet durch eine Verschlußkappe (6) auf besagtem weiblichen Luer-Anschluß bzw. Luer-Lock-Anschluß (5) zur Vermeidung von Kontaminationen durch unbeabsichtigtes Berühren des Anschlusses.
EP19920105411 1991-04-11 1992-03-28 Mischbehälter zum Verbinden einer Spritze und Verfahren Expired - Lifetime EP0508251B1 (de)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US68506991A 1991-04-11 1991-04-11
US685069 1991-04-11

Publications (2)

Publication Number Publication Date
EP0508251A1 EP0508251A1 (de) 1992-10-14
EP0508251B1 true EP0508251B1 (de) 1995-08-02

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ID=24750659

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EP19920105411 Expired - Lifetime EP0508251B1 (de) 1991-04-11 1992-03-28 Mischbehälter zum Verbinden einer Spritze und Verfahren

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EP (1) EP0508251B1 (de)
JP (1) JP3319777B2 (de)
DE (1) DE69203774T2 (de)
ES (1) ES2075513T3 (de)

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7722733B2 (en) 2004-03-29 2010-05-25 Baxter International Inc. Method for sterile connection of tubing
US8146642B2 (en) 2002-01-31 2012-04-03 Baxter International Inc. Apparatus and method for connecting and disconnecting flexible tubing

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20030187421A1 (en) * 2002-03-28 2003-10-02 Keith Manica Container and method of sealing
BR102017008203B1 (pt) * 2017-04-20 2020-05-05 Caetano Norival câmara de diluição e gotejamento

Family Cites Families (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR659395A (fr) 1928-08-22 1929-06-27 Bougie d'allumage pour moteur à explosions
GB1428373A (en) * 1972-06-12 1976-03-17 Smith & Nephew Res Containers
US4336802A (en) * 1980-07-28 1982-06-29 Baxter Travenol Laboratories, Inc. Parenteral solution container for aseptic mixing
US4326526A (en) * 1980-09-18 1982-04-27 Becton, Dickinson And Company Dialysate bag assembly for continuous ambulatory peritoneal dialysis
CH659395A5 (en) * 1982-05-11 1987-01-30 Solco Basel Ag Flexible bag for the reception and transfer of blood or infusion solutions
JPS6171064A (ja) * 1984-09-13 1986-04-11 日本赤十字社 血液成分の分離用器具
JP2894458B2 (ja) * 1990-08-02 1999-05-24 川澄化学工業 株式会社 検査用血液保存容器

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8146642B2 (en) 2002-01-31 2012-04-03 Baxter International Inc. Apparatus and method for connecting and disconnecting flexible tubing
US7722733B2 (en) 2004-03-29 2010-05-25 Baxter International Inc. Method for sterile connection of tubing
US8162021B2 (en) 2004-03-29 2012-04-24 Baxter International Apparatus for sterile connection of tubing

Also Published As

Publication number Publication date
DE69203774D1 (de) 1995-09-07
JP3319777B2 (ja) 2002-09-03
JPH05245185A (ja) 1993-09-24
EP0508251A1 (de) 1992-10-14
ES2075513T3 (es) 1995-10-01
DE69203774T2 (de) 1995-12-07

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