EP0096215B1 - Système d'atténuation pour l'atténuation des solutions visqueuses élevées des composants du sang - Google Patents

Système d'atténuation pour l'atténuation des solutions visqueuses élevées des composants du sang Download PDF

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Publication number
EP0096215B1
EP0096215B1 EP83104267A EP83104267A EP0096215B1 EP 0096215 B1 EP0096215 B1 EP 0096215B1 EP 83104267 A EP83104267 A EP 83104267A EP 83104267 A EP83104267 A EP 83104267A EP 0096215 B1 EP0096215 B1 EP 0096215B1
Authority
EP
European Patent Office
Prior art keywords
container
blood
highly viscous
diluent
viscous solutions
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
Application number
EP83104267A
Other languages
German (de)
English (en)
Other versions
EP0096215A1 (fr
Inventor
Volker Dr. Enzmann
Klaus Peter Dr. Steinhoff
Willi Korte
Dieter Brueggemann
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.)
Schiwa GmbH
Original Assignee
Schiwa 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 Schiwa GmbH filed Critical Schiwa GmbH
Priority to AT83104267T priority Critical patent/ATE25000T1/de
Publication of EP0096215A1 publication Critical patent/EP0096215A1/fr
Application granted granted Critical
Publication of EP0096215B1 publication Critical patent/EP0096215B1/fr
Expired 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
    • A61J1/1412—Containers with closing means, e.g. caps
    • 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
    • A61J1/1487—Inlet or outlet ports with friction fit, e.g. connecting tubes directly to a protruding port
    • 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
    • A61J1/18—Arrangements for indicating condition of container contents, e.g. sterile condition
    • 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
    • A61J1/1468—Containers characterised by specific material properties

Definitions

  • the invention relates to a dilution system for the dilution of highly viscous solutions from blood components, consisting of a container which is filled with a dilution liquid sterilized therein, and a connecting element which is connected to it and is provided with a puncture pin for transporting the dilution liquid to a blood preserve, the highly viscous solutions made from blood components has, as well as an interposed closure part, which is kept sterile with respect to the environment and can be opened from outside.
  • blood component therapy is a well-known method as a targeted substitution of cellular blood elements and plasma components.
  • whole blood transfusion has been replaced to a limited extent by the transfusion of red blood cell concentrate, although various scientists have described it as obsolete.
  • the proponents of whole blood transfusion always cite an essential disadvantage against the transfusion of erythrocyte concentrate that the high viscosity of erythrocyte concentrate - and the necessary dilution of the same - entail technical problems.
  • the procedures for diluting erythrocyte concentrate that are common in clinics are still time-consuming, cumbersome and hygienically not always optimal, so that the need to dilute the erythrocyte concentrate is - although at first glance irrelevant - a decisive disadvantage.
  • connection of the container for receiving the dilution liquid with the blood reservoir by means of a tube provided with puncture spikes on both sides should be mentioned here as an example.
  • connection device is known from US-A-2 954 769.
  • a flexible, compressible pipe section is provided at both ends with a hollow puncture mandrel, which is connected to the interior of the pipe section, a ball valve being provided at the transition from the pipe section to the puncture mandrel.
  • DE-A-2 531 058 describes a device which is easier to operate and is intended for blood component separation. It essentially consists of two transparent blood vessels made of soft material, which are connected to each other by a hose line.
  • the hose line serves to transfer a blood component from the first receiving container in which the blood is subjected to centrifugation; in the second container.
  • a sealed insert tube inserted into the end of the hose line initially forms a closure of the line, which can then be opened by a break at a predetermined breaking point for transferring the component.
  • a disadvantage of this device is that both containers are firmly and non-detachably connected from the outset by the hose line, both the hose line in the mouthpiece of the first container and the insert tube having to be glued or melted into the line end.
  • This is complex in terms of production technology and not very suitable for a dilution system, since in such a system the container with the dilution liquid would not be connectable to any blood product. A simple and quick application in emergencies would not be possible.
  • a container for the supplementary material is provided with an outlet pipe which is inserted into a closure member of the container and has an insertion end.
  • the opening of the closure member is closed by a flap which, when the outlet pipe is pressed into the rubber closure of the bottle containing the stock solution, lifts from its seat into the opening. After opening the flap, the stock solution can flow back into the container for the supplementary material.
  • the object on which the present invention is based was accordingly to take technical measures in a system for diluting highly viscous solutions from blood components of the type described at the outset, by means of which backflow of the solutions of the stored blood into the container with the dilution liquid is prevented while this container is on the blood bank is connected. This task arises above all if the container with the dilution liquid is to remain connected to the stored blood for reasons of sterility until the blood is consumed.
  • the solution to the problem of the invention is that in a dilution system of the type described above, the container filled with the dilution liquid is deformable and the connecting element is equipped with a check valve.
  • a transparent tube 2 preferably made of plastic, is inserted into a cylindrical container 1 made of deformable plastic material and is welded to the container 1.
  • the connecting element described in detail below - see FIG. 2 - is pressed into the hose 2.
  • the connecting element consists of two parts, preferably made of plastic, the piercing mandrel 5 and the closure part 6 and a ball 7 located inside the closure part 6, preferably made of steel.
  • the piercing mandrel 5 consists of an externally slightly conical part 8 on one side and a cylindrical part 9 with a short thickening 10 on the other side. Both parts are divided by a collar 11 which is slightly turned on the side of the cylindrical part 9.
  • the conical part 8 has its largest diameter on the adjoining collar 11.
  • the thickening 10 also adjoins the collar 11.
  • the piercing mandrel 5 is drilled hollow along its entire length.
  • the cylindrical part 9 is chamfered at the front from two sides in a wedge shape, while at the end of the conical part 8 there are four equally shaped bumps 12 distributed evenly around the circumference.
  • the closure part 6 consists of three merging cylinders 13, 14, 15, each with a larger diameter, with a subsequent collar 16.
  • the two larger cylinders 14, 15 are hollow-drilled until the transition from the middle cylinder 14 to the smallest cylinder 13, namely the cylinder 14 with the same inside diameter as the piercing mandrel 5 and the cylinder 15 with a conical bore, the pitch of which corresponds exactly to the pitch of the conical outside diameter of the piercing mandrel 5.
  • the cylindrical bore is provided with a spherical countersink. Closure part 6 and piercing mandrel 5 are pressed together to form the connecting element 3 via the conical inner bore of the closure part 6 and the conical outer shape of the piercing mandrel 5.
  • the ball 7 is inserted into the conically drilled part of the closure part 6, the diameter of which is on the one hand larger than the cylindrical bore and on the other hand smaller than the small diameter of the conical bore and whose diameter corresponds to the countersink mentioned above. With this type of construction, the ball 7 is movably supported in the conically drilled part of the closure part 6.
  • the cylinder 15 of the closure part 6 forms an airtight connection with the hose 2 - the container 1 and the connecting element 3 are combined into one unit, the dilution system.
  • the hose 2 is just long enough that in the assembled state the cylinder 13, which is not pierced and is easily broken off, lies in the hose 2 and not in the container 1.
  • the type of application of the dilution system according to the invention is briefly described below.
  • the container 1 filled with dilution liquid for example 0.9% saline solution, Ringer's solution or Ringer's lactate, is connected to the stored blood by means of the piercing mandrel 5.
  • the recipient organism is also connected to the blood bank by means of a transfusion device.
  • the cylinder 13 of the connecting element 3 lying under the hose 2 is broken off and the dilution liquid lying in container 1 is transferred into the blood reservoir by compressing the container 1; this dilutes the erythrocyte concentrate and the diluted erythrocyte concentrate is supplied to the recipient organism via the transfusion device.
  • the ball 7 stored in the connecting element 3 acts as a check valve.
  • the ball 7 is pressed against the bumps 12 and the dilution liquid is pressed through between the bumps 7; a backflow into the container 1 is prevented by the ball 7 immediately lying in the above-mentioned spherical countersink in the event of a backflow.
  • the advantages achieved by the invention consist in particular in creating a dilution system for diluting highly viscous solutions from blood components, which can be used quickly and easily, especially in emergencies. Sterilization of the dilution system in the outer bag ensures hygienic safety.

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)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)

Claims (2)

1. Système de dilution pour diluer des solutions fortement visqueuses de constituants du sang, qui comporte un récipient (1) rempli d'un liquide diluant qui y est stérilisé et un élément de liaison (3) s'y raccordant et muni d'un poinçon d'introduction (5) pour transporter le liquide diluant à la réserve de sang qui présente les solutions à haute viscosité de constituants du sang, ainsi qu'une pièce d'obturation (6, 13) s'ouvrant vers l'extérieur, maintenue stérile par rapport à l'environnement et interposée entre le récipient (1) et l'élément de liaison (3), caractérisé par le fait que le récipient (1) rempli de liquide de dilution est déformable et l'élément de liaison (3) est muni d'un clapet de retenue (7).
2. Système de dilution selon la revendication 1, caractérisé par le fait que le système de dilution est logé stérile dans une poche (4) enveloppante.
EP83104267A 1982-05-08 1983-04-30 Système d'atténuation pour l'atténuation des solutions visqueuses élevées des composants du sang Expired EP0096215B1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AT83104267T ATE25000T1 (de) 1982-05-08 1983-04-30 Verduennungssystem zur verduennung hochviskoser loesungen aus blutbestandteilen.

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE3217450 1982-05-08
DE19823217450 DE3217450A1 (de) 1982-05-08 1982-05-08 Verduennungssystem zur verduennung hochviskoser loesungen aus blutbestandteilen

Publications (2)

Publication Number Publication Date
EP0096215A1 EP0096215A1 (fr) 1983-12-21
EP0096215B1 true EP0096215B1 (fr) 1987-01-21

Family

ID=6163156

Family Applications (1)

Application Number Title Priority Date Filing Date
EP83104267A Expired EP0096215B1 (fr) 1982-05-08 1983-04-30 Système d'atténuation pour l'atténuation des solutions visqueuses élevées des composants du sang

Country Status (3)

Country Link
EP (1) EP0096215B1 (fr)
AT (1) ATE25000T1 (fr)
DE (2) DE3217450A1 (fr)

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
SE8505875L (sv) * 1985-12-12 1987-06-13 Mediplast Ab Anordning for overforing av en substans mellan tva kerl
DE19702402A1 (de) 1997-01-24 1998-07-30 Beyersdorf Friedhelm Univ Prof Verfahren und Reperfusionsvorrichtung

Family Cites Families (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
BE548456A (fr) * 1955-09-23 1956-06-30
US2954769A (en) * 1958-08-20 1960-10-04 American Cyanamid Co Aseptic liquid transfer apparatus
DE1616489A1 (de) * 1968-03-08 1971-04-29 Hoechst Ag Kombiniertes UEberleitungs- und Infusionsgeraet

Also Published As

Publication number Publication date
DE3217450A1 (de) 1983-11-10
ATE25000T1 (de) 1987-02-15
EP0096215A1 (fr) 1983-12-21
DE3369249D1 (en) 1987-02-26

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