EP0508251B1 - Admixture container for connecting a syringe and method - Google Patents

Admixture container for connecting a syringe and method Download PDF

Info

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
German (de)
English (en)
French (fr)
Other versions
EP0508251A1 (en
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.)
Filing date
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/en
Application granted granted Critical
Publication of EP0508251B1 publication Critical patent/EP0508251B1/en
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

Links

Images

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)
EP19920105411 1991-04-11 1992-03-28 Admixture container for connecting a syringe and method Expired - Lifetime EP0508251B1 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US68506991A 1991-04-11 1991-04-11
US685069 1996-07-23

Publications (2)

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

Family

ID=24750659

Family Applications (1)

Application Number Title Priority Date Filing Date
EP19920105411 Expired - Lifetime EP0508251B1 (en) 1991-04-11 1992-03-28 Admixture container for connecting a syringe and method

Country Status (4)

Country Link
EP (1) EP0508251B1 (ja)
JP (1) JP3319777B2 (ja)
DE (1) DE69203774T2 (ja)
ES (1) ES2075513T3 (ja)

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

Similar Documents

Publication Publication Date Title
US5368586A (en) Closure for a drug-vial
EP0416454B1 (en) Method of and apparatus for administering medicament to a patient
EP0519240B1 (en) Syringe with a closed sealable tube
EP1685864B1 (en) Method and connector for maintaining sterility of a medical fluid
AU676753B2 (en) Drug delivery system
EP0684857B1 (en) In-line drug delivery device and method
US5547471A (en) In-line drug delivery device for use with a standard IV administration set and a method for delivery
US4898209A (en) Sliding reconstitution device with seal
US6468261B1 (en) Medical fluid delivery system
EP0623033B1 (en) Adaptor for drug delivery
AU2018316283B2 (en) Reconstitution device, system, and method to administer a drug in a moderate bolus
WO1981001241A1 (en) System for the sterile mixing of materials
WO2011011048A2 (en) Vial transfer convenience iv kits and methods
US20120127824A1 (en) Device/system for mixing liquids, drugs and solutions before administration into the human body
EP0522107B1 (en) Method and system for creating on site, remote from a sterile environment, parenteral solutions
EP0508251B1 (en) Admixture container for connecting a syringe and method
KR20210021029A (ko) 고진공 병을 통해서 약물을 투약하기 위한 재구성 시스템
JP4658570B2 (ja) 輸液チューブ、薬液投与セット及び連結用アダプタ
US12121496B2 (en) Reconstitution device, system, and method to administer a drug in a moderate bolus

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

AK Designated contracting states

Kind code of ref document: A1

Designated state(s): DE ES FR GB IT NL

17P Request for examination filed

Effective date: 19920827

17Q First examination report despatched

Effective date: 19940704

GRAA (expected) grant

Free format text: ORIGINAL CODE: 0009210

AK Designated contracting states

Kind code of ref document: B1

Designated state(s): DE ES FR GB IT NL

ITF It: translation for a ep patent filed
REF Corresponds to:

Ref document number: 69203774

Country of ref document: DE

Date of ref document: 19950907

ET Fr: translation filed
REG Reference to a national code

Ref country code: ES

Ref legal event code: FG2A

Ref document number: 2075513

Country of ref document: ES

Kind code of ref document: T3

PLBE No opposition filed within time limit

Free format text: ORIGINAL CODE: 0009261

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

Free format text: STATUS: NO OPPOSITION FILED WITHIN TIME LIMIT

26N No opposition filed
NLT1 Nl: modifications of names registered in virtue of documents presented to the patent office pursuant to art. 16 a, paragraph 1

Owner name: NPBI INTERNATIONAL B.V.

REG Reference to a national code

Ref country code: FR

Ref legal event code: CD

REG Reference to a national code

Ref country code: GB

Ref legal event code: IF02

PGFP Annual fee paid to national office [announced via postgrant information from national office to epo]

Ref country code: DE

Payment date: 20110331

Year of fee payment: 20

Ref country code: FR

Payment date: 20110408

Year of fee payment: 20

Ref country code: ES

Payment date: 20110427

Year of fee payment: 20

Ref country code: GB

Payment date: 20110328

Year of fee payment: 20

PGFP Annual fee paid to national office [announced via postgrant information from national office to epo]

Ref country code: NL

Payment date: 20110404

Year of fee payment: 20

PGFP Annual fee paid to national office [announced via postgrant information from national office to epo]

Ref country code: IT

Payment date: 20110329

Year of fee payment: 20

REG Reference to a national code

Ref country code: DE

Ref legal event code: R071

Ref document number: 69203774

Country of ref document: DE

REG Reference to a national code

Ref country code: DE

Ref legal event code: R071

Ref document number: 69203774

Country of ref document: DE

REG Reference to a national code

Ref country code: NL

Ref legal event code: V4

Effective date: 20120328

REG Reference to a national code

Ref country code: GB

Ref legal event code: PE20

Expiry date: 20120327

PG25 Lapsed in a contracting state [announced via postgrant information from national office to epo]

Ref country code: DE

Free format text: LAPSE BECAUSE OF EXPIRATION OF PROTECTION

Effective date: 20120329

PG25 Lapsed in a contracting state [announced via postgrant information from national office to epo]

Ref country code: GB

Free format text: LAPSE BECAUSE OF EXPIRATION OF PROTECTION

Effective date: 20120327

REG Reference to a national code

Ref country code: ES

Ref legal event code: FD2A

Effective date: 20130719

PG25 Lapsed in a contracting state [announced via postgrant information from national office to epo]

Ref country code: ES

Free format text: LAPSE BECAUSE OF EXPIRATION OF PROTECTION

Effective date: 20120329