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
• • 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
  • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
  • A61M39/22—Valves or arrangement of valves
  • A61M39/221—Frangible or pierceable closures within tubing
  • A61M2039/222—Frangible or pierceable closures within tubing frangible within tubing or bags
• • 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
  • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
  • A61M39/22—Valves or arrangement of valves
  • A61M39/221—Frangible or pierceable closures within tubing

Definitions

• the present invention relates to a blood bag for use in separating blood components, said bag having at least two connections from which pipes or hoses extend to a container for the sterile transfer of separated blood components.
• Blood bags are used generally in clinical blood-activi ⁇ ties on a world-wide basis and comprise a flexible, collap ⁇ sible container made of a relatively thin plastic material. When empty, the blood bag has an essentially rectangular or square shape and a relatively small extension in depth.
• the blood bags are normally produced from a thin-walled hose which is first cut and then sealed along an upper and a lower edge, or from so-called double foil, which is sealed around the bag so as to form an upper, a lower edge and two side edges. Hose connections and valve connections of different kinds can be incorporated in said edges when sealing the bag.
• one edge as used in the following description, is meant one of these sealed edges.
• a system of this kind is described in Swedish Patent Specification No. 7902761-1, according to which the blood is drained into a bag which has outlet openings in both the upper and the lower edges of the bag.
• the layer that contains blood plasma is pressed out through the upper outlet opening of the bag, whereas the layer that contains red blood cells is pressed out through the lower outlet opening of said bag.
• the intermediate buf- fycoat layer thus remains in the blood bag.
• An object of the present invention is to provide a blood bag for the separation of blood components and from which plasma and red blood cells can be pressed into the side containers while leaving the buffycoat fraction in said bag, and in which bag the side-container connections are arranged in one edge of the bag.
• the inventive blood bag has at least two connec ⁇ tions from which pipes or hoses extend to side containers and in which connections are disposed in one edge of the bag.
• the first of these connections either communicates directly with the blood bag at said edge or is an openable connection, and the second of said connections communicates directly with the interior of said blood bag, or is an openable connection, at a given distance from said edge.
• a further advantage afforded by the inventive blood bag is that the lower fraction can be pressed from the bag while leaving the oldest and therapeutically least valuable red blood vessels in the bag, these cells settling at the ab- solute bottom of the bag.
• Figure 1 illustrates an embodiment of an inventive blood bag having two side containers connected thereto;
• Figure 2 illustrates another embodiment of an inventive blood bag having side containers connected thereto
• Figure 3 is a longitudinal section view of one embodi ⁇ ment of a bag connection which includes a rod that can be pressed into the bag;
• Figure 4 is a detailed view similar to Figure 3 and shows the rod pressed into the blood bag;
• Figure 5 is a detailed view in longitudinal section of another embodiment of a connection comprising a rod which can be pressed into the bag;
• Figure 6 is a view similar to Figure 5, showing the rod pressed into the bag.
• Figures 1 and 2 illustrate a set of mutually connected containers intended for use when dividing whole blood into plasma, buffycoat and erythrocyte cell fractions.
• the con ⁇ tainer set includes an inventive blood bag 1 which is pro- vided with two connections 7, 8 in one edge of the bag. Connected to these connections 7, 8 are two side containers 2, 3, by means of conduits or hoses 4, 5, through which fluid is transferred from the blood bag to the side containers.
• at least one further connection 9 ( Figure 3) is provided for the connection of a blood draining hose by means of which the bag is filled with the whole blood to be sepa ⁇ rated into its various components.
• the blood bag 1 may, for instance, be a standardized blood bag made of PVC-foil and intended to be filled with a standard blood unit of about 520 ml, including about 63 ml anticoagulant.
• the one side container 3 is intended for the collection of plasma and is connected to the top of the bag 1 by a conduit or hose 5, through the intermediary of a connector 7.
• the other side container 2 contains approximate- ly 100 ml erythrocyte nutrient solution 6 (for example SAG- MAN) and is intended for collecting the erythrocyte cell concentrate or fraction.
• This second container is connected to the blood bag by means of a hose or conduit 4, which similar to the hose or conduit 5 is attached to a connector at the top of the bag.
• a conduit 10 is connected to the connector 8 and extends within the bag and terminates at a given distance above the bottom thereof.
• the conduit 10 may be a direct continuation of the hose 4 or may comprise a more rigid conduit or hose connected to the hose 4.
• Normally included in the circuit is a so-called shear pin 4a, i.e. a closure means which can be opened by breaking the shear pin.
• the conduit 10 is relatively long and ter ⁇ minates at the bottom of the bag, or a given distance above said bottom, such that the bottom orifice of the conduit will be located in the layer of erythrocyte cells subsequent to centrifugation. This embodiment enables plasma and cell concentrate to be pressed from the bag while leaving the intermediate buffycoat layer therein.
• the embodiment illustrated in Figure 2 differs from the embodiment described with reference to Figure 1, primarily in that the conduit 19 extending within the bag is shorter than the conduit 10 of the Figure 1 embodiment, intended for a corresponding purpose.
• the length of the conduit 19 is such that said conduit will not reach the buffycoat layer formed in the centrifugation process, but opens into the plasma layer.
• the plasma is pressed out first.
• the buffycoat layer then rises in the bag so as to cover the orifice of the conduit 19 prior to opening the hose 4 and the erythrocyte cell concentration is pressed out into the side container 2.
• the advantage with this embodiment is that cell concentrate can be recovered free from contamination by the buffycoat fraction.
• the con- duit 19 is filled with blood at the same time as the bag is filled.
• Figure 3 is a longitudinal section view of one embodi ⁇ ment of a connector 8 provided in one edge of the blood bag.
• the remaining bag connectors are also gathered in the same edge, and include a connector 7 for a hose which leads to a side container for collecting plasma, and a connector 9 for the connection of a blood drainage hose, and two further connectors, not clearly shown in the Figure.
• One or both of these connectors are used in subsequent processing of the residual contents of the bag.
• the connector 8 includes a sleeve 11 whose one end is welded to the bag and whose other end is connected to a hose 4 which leads to a side container for collecting erythrocyte cells. Seated within the sleeve is an axially moveable hollow rod 12. The rod 12 can be forced down into the sleeve, so as to form a sleeve extension in the bag, such that the connec ⁇ ting conduit leading to the side container 2 will terminate at a desired distance from the bottom of the bag.
• the upper end 13 of the rod 12 may be rounded, so as to enable the sleeve to be readily pressed manually from the bag, while the bottom end may be pointed, as at 14, for the purpose of puncturing a sealing membrane 15 located in the sleeve at- tachment in the bag.
• the rod is also preferably provided with shoulders or fins 16, which prevent the rod from being press ⁇ ed free of the sleeve 11. The shoulders may also function to effect a seal against the wall of the lead-through or bushing in the top of the bag.
• Figure 4 illustrates the connector shown in Figure 5, subsequent to having pressed the rod 12 out of the sleeve.
• the length of the rod 12 is adapted so that the rod orifice is located in the layer of red blood cells present in the lower part of the bag subsequent to centrifugation, i.e. the rod has an insertable length which corresponds at least to half the length of the bag and which preferably corresponds to the full length of said bag.
• the rod can be given a length cor ⁇ responding to the short conduit 19 of the Figure 2 e bodi- ment.
• the sleeve 11 consists of a relatively soft hose which can be compressed elastically in its axial direction. This enables the rod to be moved axially in the sleeve, by repeated axial compression of the hose. I'Jhen the hose is compressed along the rod. the internal diameter of the hose is widened and the rod will move stepwise axially in the hose.
• Figures 5 and 6 are longitudinal sectional views of another embodiment of a connection comprising an axially displaceable hollow rod which is pressed into the blood bag.
• Figure 5 illustrates the connection prior to pressing the rod into the bag
• Figure 6 illustrates the connection subsequent to having pressed-in said rod.
• the hollow rod 12 of this embodiment is fixedly connected to a protective sleeve 17 and the upper end of the rod is connected to the hose 4, wherein the protective sleeve can also be used as a connecting element.
• the protective sleeve is so arranged that said sleeve will pleat or shirr around the rod 12 when said rod is pressed-in through a sealing lead-through or bushing 18 provided in the top of the bag.
• Pleating of the sleeve is either achieved by providing the sleeve with fold-lines, or by providing said sleeve with a wall of such thinness that the sleeve is pleated spontaneously when compressed.
• the inventive blood bag can be used in the following way:
• Blood is drained into the blood bag, for instance di- rectly from a blood donor, through a blood drainage hose leading to a connector 9 at the top of the bag.
• a blood drainage hose leading to a connector 9 at the top of the bag Normally, about 450 ml of blood is drained into the bag, said blood being admixed with about 63 ml anticoagulant (e.g. CPD-solu- tion) , which may have been introduced into the bag prior to its delivery or which is introduced during the blood draining process.
• anticoagulant e.g. CPD-solu- tion
• the blood draining hose When draining of the blood is completed, the blood draining hose is sealed-off, for instance with the aid of a hose clamp, and the blood bag with the side containers han- ging therefrom, is placed in the centrifuge. Centrifugation of the blood causes the blood to separate into the components plasma, buffycoat and red blood cells, which settle in layers in the aforesaid order, from the top to the bottom of the bag.
• the different component layers also have certain divi- sions within themselves.
• the upper layer in the cell sediment contains the youngest red blood cells, so-called neocytes, which have particular therapeutic value.
• the blood plates which have a still further lower specific weight, stratify on the layer of white blood cells.
• the uppermost layer in the blood bag contains the plasma, which is either essentially free of cells or rich in blood platelets, depen ⁇ ding on the centrifuging technique applied and also depending on the g-factor and centrifugation time, i.e. G-seconds.
• the erythrocyte cells which settle furthest down in the bag are the last to reach the mouth of the conduit 19. That portion which remains will contain the major part of the oldest and therapeutically least valuable erythrocytes.
• the erythrocyte cell concentrate isolated in the side container 2 will thus obtain an improved therapeutic quality, owing to a higher proportion of young cells present.
• the plasma located at the highest level in the bag will be pressed out through the connection 7 and the hose 5, into the plasma side-container 3, whereafter the hose 5 can be sealed-off and cut by means of a tube sealer for instance.
• the red blood cells are pressed from the bag through the conduit 19 or the conduit 10 (with the conduit 10 or the rod 12 at a selected distance from the bottom of the bag) and the hose 4 and into the side container 2 for erythrocyte cells. Remaining in the blood bag are the buffycoat fraction and minor quantities of plasma and erythrocyte cells. This remaining fraction can then be processed in a further purifying stage.
• the blood components can be pressed from the bag with the aid, for instance, of a device of the kind described in Swedish Patent Specification No. 7902760-3.
• the blood bag is placed between a fixed support plate and a moveable press plate, which is moved successively towards the support plate while monitoring the component layers with photocells.
• at least one of the plates may be provided with a pliable or yieldable layer of, e.g. rubber or foam plastic of suitable rigidity, so as to enable the rod to be pressed into said pliable layer when the extent to which the plates are brought together is great ⁇ er than the dimension of the rod.
• the blood components can be pressed from the bag il ⁇ lustrated in Figure 2 in essentially the same manner. In this case, however, it is necessary to remove the plasma fraction first, so that the buffycoat fraction will be moved to the top of the bag, above the mouth of the conduit 19, before opening the hose 4 leading to the side container 2.

Landscapes

• Health & Medical Sciences (AREA)
• Veterinary Medicine (AREA)
• Hematology (AREA)
• Life Sciences & Earth Sciences (AREA)
• Animal Behavior & Ethology (AREA)
• General Health & Medical Sciences (AREA)
• Public Health (AREA)
• Heart & Thoracic Surgery (AREA)
• Pharmacology & Pharmacy (AREA)
• Vascular Medicine (AREA)
• Engineering & Computer Science (AREA)
• Anesthesiology (AREA)
• Biomedical Technology (AREA)
• External Artificial Organs (AREA)
• Battery Mounting, Suspending (AREA)
• Connection Of Batteries Or Terminals (AREA)

Priority Applications (1)

Applications Claiming Priority (2)

Publications (1)

Family

ID=20379119

Family Applications (1)

Country Status (5)

Cited By (7)

Citations (1)

• 1990
  • 1990-04-06 SE SE9001271A patent/SE9001271D0/sv unknown
• 1991
  • 1991-04-05 JP JP50795991A patent/JP3220750B2/ja not_active Expired - Fee Related
  • 1991-04-05 EP EP91908314A patent/EP0523180B1/en not_active Expired - Lifetime
  • 1991-04-05 WO PCT/SE1991/000251 patent/WO1991015182A1/en not_active Ceased
  • 1991-04-05 DE DE91908314T patent/DE69100513T2/de not_active Expired - Fee Related

Patent Citations (1)

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