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
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
  • A61M1/02—Blood transfusion apparatus
  • A61M1/0209—Multiple bag systems for separating or storing blood components
  • A61M1/0236—Multiple bag systems for separating or storing blood components with sampling means, e.g. sample bag or sampling 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
  • A61J1/05—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
  • A61J1/12—Bag-type containers with means for holding samples of contents

Definitions

• the present invention relates to a bag or a bag system for collecting and storing blood and a method for collecting and storing blood.
• JP 10000224A discloses a bag system for isolating stem cells and precursor cells from umbilical cord blood by centrifugation.
• This system consisting of 6 bags equipped with connectors and tubes to lead the blood from bag to bag, comprises one bag wherein the obtained leucocyte component containing the above mentioned cells are fro ⁇ zen.
• the problem relating to this bag is, however, the same, as it is not possible to defrost part of the cells without destroying the rest.
• the invention relates to a bag or a bag system for col ⁇ lecting and storing blood as defined in claim 1, a bag or a bag system for collecting and storing blood in combination with a mixing bag as defined in claim 4, and a bag or a bag system for collecting, mixing, and storing blood as defined in claim 5.
• a bag or a bag system according to the present invention may contain a system of storage chambers alone, equipped only with an opening for receiving blood, or the opening for receiving blood may comprise an inlet channel.
• This inlet channel can be a small tube suitable to be con- nected to a mixing chamber adapted with e.g. a snap lock, a clamp or a similar easy operational closing device.
• Another aspect of the invention is a bag or a bag system for collecting and storing blood in combination with a mixing bag, where the mixing bag comprises at least one mixing chamber, an opening for receiving blood and an opening for discharging blood.
• the opening for receiving blood and the opening for discharging blood may be the same.
• the opening for discharging blood is adapted to be connected to the opening for receiving blood in the bag or the bag system for collecting and storing blood, e.g. by use of suitable connectors .
• a further aspect of the invention is a bag or a bag sys- tern for collecting and storing blood comprising a mixing chamber, where said mixing chamber can be sealed off from the storage chambers by closing e.g. a snap lock or by using a clamp or by welding.
• the mixing chamber is arranged in such a relation to the storage chambers so that it can be sealed off therefrom and removed before storage.
• a mixing chamber of a bag or a bag system according to the invention should have a volume which corresponds to or is bigger than the sum of the volumes of the primary and secondary storage chambers .
• the mixing bag should preferably have a volume at least twice as big as the sum of the volumes of the primary and secondary storage chambers.
• the mixing chamber may e.g. have a volume in the range of 100 to 500 ml, preferably 225 to 400 ml, more preferably 250 to 300 ml.
• the mixing chamber may e.g. have a volume in the range of 100 to 500 ml, preferably 125 to 400 ml, more preferably 150 to 250 ml.
• the mixing chamber may further comprise at least one port for injection of anticoagulation and/or preserving agents and/or at least one port for extracting blood in order to perform tests, e.g. to detect contamination by vira.
• the primary and secon- dary chambers are in liquid communication with each other.
• This liquid communication may preferably be provided by pipe connections with a length in the range of 10-20 mm, preferably 12-15 mm.
• the pipe connections has a length in the range of 10-300 mm, preferably about 100 mm.
• the inner diameter of said pipe connections may be in the range of 2-10 mm, preferably 3-8 mm, more preferably 4-6 mm when the pipes are in a non collapsed condition.
• each of the storage chambers e.g. by welding (heat welding, impulse welding or other) or by closing a snap lock or a clamp, preferably shortly after the filling is completed, it is i por- tant to ensure that only a minimal amount of the obtained blood is destroyed.
• the bag or the bag system according to the invention which is provided with the above mentioned pipe connections containing only a minimum of blood, ensures that only a very small percentage of the total amount of blood is damaged in connection with the closing of these channels by e.g. heat.
• a bag or a bag system for storing umbilical cord blood it is possible to obtain at least two, preferably at least 5 primary storage chambers, more preferably at least 8 primary storage chambers, and most preferably at least 10 primary storage chambers, all containing blood.
• the number of chambers filled with blood depends on how much blood it is possible to extract from the umbilical cord and the placenta as well as how the blood bag is de ⁇ signed.
• the volume of the primary storage chambers is usually in the range of 10 to 40 ml, preferably 25 to 35 ml, more preferably 25 to 30 ml.
• the vol ⁇ ume of the primary storage chambers is in the range of 10 to 80 ml, preferably 25 to 70 ml, more preferably 25 to 50 ml.
• the system of chambers also comprises a number of secondary storage chambers, preferably equal to at least the number of primary storage chambers, all of which may be sealed off and removed individually as the primary cham ⁇ bers.
• the object of these secondary chambers is to provide small amounts of blood for test purposes. Therefore the ratio between the volumes of the primary and secon- dary storage chambers is preferably between 40:1 and 60:1, more preferably about 50:1. In another embodiment the ratio between the volumes of the primary and secondary storage chamber is in between 40:1 and 150:1, preferably between 50:1 and 80:1.
• This particular feature is of great importance, since it is essential to determine the quality of the blood in order to find out the right amount of blood needed for the treatment, to check for contamination of the blood (e.g. bacteria) or to perform a gene test.
• all the primary storage chambers are marked or adapted to be marked individually, each with at least one corresponding secondary storage chamber.
• the bag or the bag system itself is preferably marked or adapted to be marked with a date and/or a number in order to be able to identify the bag.
• the primary storage chambers can have various shapes, preferred embodiments, however, are those where the shape is substantially rectangular or substantially round when the bag or the bag system is in a collapsed condition.
• the bag or the bag sys ⁇ tem is made of a suitable material, e.g. a material of medical or pharmaceutical grade.
• suitable materials are e.g. a polyethylen, an ethylene vinyl acetate copolymer, a fluorine resin, a polyimide, silicone, an ABS polymer (acrylonitrile/butadien/styrene polymer) or a polycarbonate .
• the bag or the bag system may consist of one or more fo- lio layers, e.g. joined by welding, and in cases regarding more than one folio layer, the material of the layers may be selected among the above-mentioned materials and may be identical or different.
• the bag system comprises primary and secondary storage chain- bers made of one of the above mentioned materials, said bag system being arranged or being able to be arranged in a second bag e.g. surrounding the bag system by the sec ⁇ ond bag made of a suitable material.
• the second bag may be divided into a number of compartments.
• the invention also relates to a method for collecting and storing umbilical cord blood and/or blood from a pla ⁇ centa, comprising the steps of:
• said primary and said secondary storage chambers are arranged in a bag or a bag system wherein the channels are linked to each other with intermediate seals, and the volume of the primary storage chambers is larger than the volume of the secondary storage chambers.
• step e)-i) may be carried out after storing the blood for no longer than 24 hours under conditions with no bacteria growth, e.g. in a refrigera ⁇ tor.
• the extracting of blood from an umbilical cord and leading it into a mixing chamber may be done in any conventional way.
• the extracting should be done in a way accepted by those skilled in the art.
• the anticoagulation agent and/or the preserving agent may be added after the blood has been led into the mixing chamber, however, it is preferred that they are already present in the chamber at the time the blood is led, which simplifies the method, since the mixing chambers can be prepared for use in advance.
• the mixing chamber is provided with at least one extra port to facilitate the addition of anticoagula- tion agent and/or preserving agent.
• the mixing chamber is brought into liquid communication with the storage chambers of the bag or the bag system according to the invention.
• the connection can be made by use of tubes and connectors, or in a preferred embodiment of the invention simply by opening a snap lock between the mixing chamber and the storage chambers.
• the mixing chamber Since there is no need to store the attached empty mixing chamber, it is preferred to remove the mixing chamber, e.g. by cutting it of or removing the tubes and connec ⁇ tors that have been used.
• the liquid communication between the chambers has to be sealed off. This may preferably be done by use of heat.
• the bag or the bag system is frozen to a temperature below about -70 °C to make sure that the blood can be stored until the need for use thereof arises.
• Fig. 1 illustrates a preferred embodiment of a bag according to the invention comprising a mixing chamber.
• Fig. 2 illustrates a bag according to the invention adapted to be connected with a mixing bag.
• Fig. 3 illustrates a bag in combination with a mixing bag according to the invention.
• Fig. 4 illustrates a bag system according to the inven ⁇ tion comprising a mixing chamber.
• Fig. 5 illustrates another embodiment of storage chambers as a part of a bag system according to the invention.
• Fig. 1 illustrates a bag according to the invention comprising a mixing chamber (1) with a double welding (5), and an inlet (11) equipped with a tube (3), which tube (3) at one end is equipped with a connector (4) to be connected with a needle for harvesting blood.
• Two snap locks (2) and (6) are placed at the inlet (11) and at the outlet (12) of the mixing chamber (1).
• the storage bag (13), which is connected with the mixing chamber (1) through a tube (14) equipped with a clamp (7), comprises ten primary storage chambers (8) and ten secondary storage chambers (9) in liquid communication with each other via pipe connections (10).
• the dotted lines show where the bag or the bag system is welded in order to seal off each chamber after the bag has been filled with blood.
• the blood is led into the mixing chamber (1), where the above mentioned necessary agents are preferably already present, then the snap lock (2) is closed, and the bag is turned upside down or shaken in order to mix the ingredients properly. Then the snap lock (6) is opened and the blood mixture flows into the storage bag (13) filling up as many primary (8) and secondary (9) storage chambers as possible. To make sure that the blood mixture flows properly into the chambers, the person handling the bag can preferably squeeze or shake the bag a little to ease the flow of the blood mixture.
• the clamp (7) is closed and the mixing chamber (1) is cut off. Then the pipe connections (10) are closed e.g. by welding, either shortly after the bag has been filled or at the latest just before the bag is frozen.
• the welding can be performed at the site, if the proper welding equipment is available or the bag can be placed at a temperature where substantially no bacteria can grow for up to 24 hours, and during that time be transported to a facility at which the welding can be performed.
• Fig. 1 illustrates a preferred embodiment of a bag according to the invention wherein the mixing chamber constitutes part of the bag.
• the mixing chamber is included as a part of the bag, the risk of infection has been minimised, since there are no unnecessary contact with the surroundings, such as transferring the blood from one bag to another, once the blood has been led into the bag.
• This bag also ensures that only a minimum of the blood is lost or destroyed during the process of collecting and storing the blood. In cases where the amount of blood obtained from the umbilical cord and the placenta is very small, this is particularly important.
• FIG. 1 shows a storage bag according to the invention with an opening for receiving blood (21) equipped with a snap lock (22) and a clamp (23) .
• the bag comprises 12 primary storage chambers (24) and 12 secondary storage chambers (25) in liquid communication with each other via pipe connections (26) .
• the dotted lines show where the bag is welded in order to seal off each chamber after the bag has been filled with blood.
• This bag is adapted to be connected with a mixing bag, wherein the extracted blood is mixed with agents mentioned above.
• Fig. 3 shows a mixing bag (31) and a storage bag (35) according to the invention.
• the mixing bag (31) consists of a mixing chamber (32) surrounded by a double welding (33) and is equipped with a connector (34) adapted to be connected with the storage bag (35) .
• the storage bag (35) which is provided with an opening for receiving blood (36) equipped with a snap lock (37) and a clamp (28), comprises ten primary storage chambers (39) and ten secondary storage chambers (40) in liquid communication with each other via pipe connections (41).
• the dotted lines show where the bag is welded in order to seal off each chamber after the bag has been filled with blood.
• Fig. 4 shows a bag system according to the invention comprising a mixing chamber (41) provided with means (51) for hanging the mixing chamber on a suitable stand or similar means, an opening for receiving and discharging blood (42) and a further port (43) for injection of additives and/or extraction of blood for tests.
• the bag system further comprises 4 primary storage chambers (48) in liquid communication with each other and the mixing chamber via pipe connections (46) and connectors (45,49) and for each primary storage chamber two secondary storage chambers (50) .
• Each primary storage chamber may be sealed off from each other and from the mixing bag by using clamps (47) .
• the blood is led into a mixing bag and treated as described above, the difference being that the mixing chamber does not constitute part of the storage bag, but is provided as a separate bag.
• the mixing chamber does not constitute part of the storage bag, but is provided as a separate bag.
• the blood flows into the primary and secondary storage chambers as already described.
• the mixing bag is disconnected from the storage bag, and the storage bag is handled as explained above.
• the primary and secondary storage chambers are preferably placed in a separate bag after being disconnected from the mixing chamber and optionally disconnected from the pipe connection by simply cutting them off.
• This bag may consist of one or more compartments each suitable for containing one ore more primary storage chambers and secondary storage chambers connected thereto. The compartments may be sepa- rated by weldings.
• the secondary storage chambers have a substantial rectangular shape. However, this is only one example, and other shapes may be just as appropriate.
• the mixing chamber is preferably provided with a double welding, but other embodiments may be just as appropriate, e.g. a triple welding, or a double folio and a single welding.
• FIG. 5 An alternative embodiment of the storage chambers is shown in fig. 5, where the primary storage chamber (61) via a connector (63) is connected to the secondary stor- age chambers (65) which are sealed off from each other and the primary storage chamber by talurites (62) after being filled with blood.
• the clamp (64) is for sealing off the storage chamber from the pipe connection.

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• Health & Medical Sciences (AREA)
• General Health & Medical Sciences (AREA)
• Veterinary Medicine (AREA)
• Public Health (AREA)
• Heart & Thoracic Surgery (AREA)
• Animal Behavior & Ethology (AREA)
• Hematology (AREA)
• Life Sciences & Earth Sciences (AREA)
• Biomedical Technology (AREA)
• Anesthesiology (AREA)
• Engineering & Computer Science (AREA)
• Vascular Medicine (AREA)
• Pharmacology & Pharmacy (AREA)
• Medical Preparation Storing Or Oral Administration Devices (AREA)
• External Artificial Organs (AREA)

Applications Claiming Priority (3)

Publications (1)

Family

ID=8099705

Family Applications (1)

Country Status (12)

Families Citing this family (5)

Family Cites Families (4)

• 1999
  • 1999-07-27 TW TW088112674A patent/TW477696B/zh active
  • 1999-07-28 PL PL99345797A patent/PL345797A1/xx unknown
  • 1999-07-28 ID IDW20010371A patent/ID30222A/id unknown
  • 1999-07-28 WO PCT/DK1999/000422 patent/WO2000006079A1/en not_active Application Discontinuation
  • 1999-07-28 HU HU0103416A patent/HUP0103416A3/hu unknown
  • 1999-07-28 BR BR9912546-3A patent/BR9912546A/pt not_active Application Discontinuation
  • 1999-07-28 AU AU50270/99A patent/AU5027099A/en not_active Abandoned
  • 1999-07-28 EP EP99934518A patent/EP1100428A1/en not_active Withdrawn
  • 1999-07-28 CA CA002338604A patent/CA2338604A1/en not_active Abandoned
  • 1999-07-28 CN CN99810655A patent/CN1316895A/zh active Pending
  • 1999-07-28 JP JP2000561936A patent/JP2002521138A/ja active Pending
• 2001
  • 2001-01-25 NO NO20010440A patent/NO20010440D0/no unknown

Non-Patent Citations (1)

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