WO2000007642A1 - Systeme de traitement de fluides biologiques - Google Patents

Systeme de traitement de fluides biologiques Download PDF

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Publication number
WO2000007642A1
WO2000007642A1 PCT/US1999/017174 US9917174W WO0007642A1 WO 2000007642 A1 WO2000007642 A1 WO 2000007642A1 US 9917174 W US9917174 W US 9917174W WO 0007642 A1 WO0007642 A1 WO 0007642A1
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WIPO (PCT)
Prior art keywords
biological fluid
blood
collection device
fluid
receiving
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.)
Ceased
Application number
PCT/US1999/017174
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English (en)
Inventor
Raleigh Carmen
Richard Spielberg
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Pall Corp
Original Assignee
Pall Corp
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Publication of WO2000007642A1 publication Critical patent/WO2000007642A1/fr
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Classifications

    • 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
    • A61M1/0218—Multiple bag systems for separating or storing blood components with filters
    • 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

  • This invention relates to the processing biological fluids such as blood and blood components, and particularly relates to minimizing contamination of the biological fluid with undesirable material such as bacteria, while allowing portions of biological fluid (e.g., for sampling) to be obtained in a closed system.
  • Blood consists of a number of components having different characteristics and uses. Accordingly, blood is typically processed to separate the components to yield a variety of valuable blood products. For example, a unit of donated whole blood can be processed to separate red cells, usually concentrated as packed red cells (PRC), platelets, usually concentrated as platelet concentrate (PC), and plasma. In accordance with some processing protocols, blood can be treated to form platelet-rich-plasma (PRP) or buffy coat, before forming PC and/or separating plasma.
  • PRC packed red cells
  • PC platelet concentrate
  • plasma plasma
  • PRP platelet-rich-plasma
  • buffy coat buffy coat
  • the separated components can be stored before being used as a blood product, particularly before being used as a transfusion product.
  • PC can be stored for several days or more
  • PRC can be stored for several weeks or more, before transfusion into a patient.
  • multiple units of some components e.g., PC, buffy coat, and/or plasma, can be pooled before producing the final blood product.
  • Stored and/or non-stored components typically include undesirable material such as bacteria.
  • Bacteria can contaminate the blood or blood component during blood collection and/or storage.
  • One source of bacterial contamination may be the blood donor's skin, which may contain one or more varieties of bacteria, e.g., gram positive bacteria such as Staphylococcus epidermidis, and SL aureus, and/or gram negative bacteria.
  • Other bacterial contaminants include, for example, coagulase negative staphylococci.
  • the bacteria may pass into the blood collection container, and the bacteria may reproduce while the blood or blood component is stored. Additionally, some phlebotomy needles may cut a disc of skin when the phlebotomy needle is inserted into the donor, allowing the bacteria-containing skin plug to pass with the blood into the blood collection container. The preparation of blood samples at the time of blood donation provides another potential route for contamination.
  • the seal of a sampling device such as an evacuated blood collection tube is punctured by a needle or spike, and a portion of blood is passed from the donor (or from the collection container), through the needle, and into the sampling device.
  • a plurality of sampling devices can be filled sequentially as desired.
  • the use of a needle or spike can compromise the integrity of the blood processing system, as it provides an opening that creates the potential for contaminants (e.g., bacteria) to enter the system.
  • contaminants e.g., bacteria
  • Some protocols for obtaining samples provide a potential route for contamination of the sample.
  • some protocols include cutting a conduit containing blood therein, and allowing the blood to "drip" into the sampling device. This opening can allow bacteria to contaminate the sample. Samples, as well as blood components prepared in open systems are not stored, and must be utilized (e.g. , analyzed or transfused), or discarded, within 24 hours.
  • the present invention provides for ameliorating at least some of the disadvantages of the prior art.
  • a first portion of a biological fluid such as blood drawn from a donor (that may include bacteria passed from the donor's skin and/or include the donor's bacteria-containing skin plug) is collected in at least one sealable biological fluid collecting device, and a second portion of the biological fluid (that is less likely to present a significant risk of bacterial contamination) is separately received, while maintaining the closed system, in a receiving container such as a blood bag.
  • at least one sealable biological fluid collecting device further comprises a cannula or needle, e.g., for penetrating the seal of a sampling device such as an evacuated blood collection tube after receiving biological fluid in the sealable collecting device.
  • Methods and systems according to embodiments of the invention provide for passing a first portion of biological fluid into a first collection device, and passing at least some volume of the first portion of the biological fluid from the first collection device into at least one additional (e.g. , a second) collection device, wherein at least the first and second collection devices can be sealed while maintaining a closed system.
  • a biological fluid collection arrangement comprising at least two biological fluid collection devices, communicating in series or in parallel, wherein the devices are capable of being sealed while maintaining a closed system.
  • the arrangement can include additional biological fluid collection devices, communicating in series and/or in parallel, and the additional devices are typically capable of being sealed while maintaining a closed system.
  • the second portion of the biological fluid e.g., donated whole blood
  • one or more components of interest e.g., plasma, platelets, and/or red blood cells
  • one or more components is depleted of leukocytes.
  • FIG. 1 illustrates an embodiment of a system according to the present invention, including a collection device for collecting a first portion of a biological fluid, and a receiving container such as a blood bag for receiving a second portion of the biological fluid.
  • Figure 2 illustrates another embodiment of a system according to the present invention, including a biological fluid collection arrangement comprising first and second collection devices in series for collecting a first portion of a biological fluid (the second collection device having a resilient wall), the system also including a receiving container such as a blood bag for receiving a second portion of the biological fluid.
  • a biological fluid collection arrangement comprising first and second collection devices in series for collecting a first portion of a biological fluid (the second collection device having a resilient wall), the system also including a receiving container such as a blood bag for receiving a second portion of the biological fluid.
  • a method for processing a biological fluid comprises passing a first portion of a biological fluid into at least one collection device capable of being sealed while maintaining a closed system, and, while maintaining the closed system, passing a second portion of the biological fluid into a first container, e.g., a receiving container such as a blood bag.
  • a first container e.g., a receiving container such as a blood bag.
  • the collection device containing the first portion of biological fluid is sealed and separated from the rest of the biological fluid processing system, and the first portion of biological fluid is sampled and/or analyzed.
  • embodiments of the method can include passing at least a part of the first portion of biological fluid from the collection device into a sampling device.
  • a biological fluid processing system comprises at least one biological fluid collection device for receiving a first portion of a biological fluid from a source of the biological fluid, the device(s) being capable of being sealed while maintaining a closed system, and at least one container (e.g. , a receiving container such as a first blood bag) for receiving a second portion of a biological fluid from the source of the biological fluid, while maintaining the closed system, wherein the biological fluid collection device and the first blood bag are in fluid communication with the source of the biological fluid.
  • a biological fluid collection device for receiving a first portion of a biological fluid from a source of the biological fluid, the device(s) being capable of being sealed while maintaining a closed system
  • at least one container e.g. , a receiving container such as a first blood bag
  • a biological fluid collecting device further comprises a needle or cannula, e.g., for use with a stoppered evacuated blood collection tube such as a vacutainer.
  • the system also includes at least one flow control device, more preferably, at least one in-line valve.
  • the system includes at least one, and preferably, at least two, additional containers such as blood bags, e.g., for blood components and/or additives.
  • An embodiment of a device for processing a biological fluid comprises at least one reservoir for collecting biological fluid, and a conduit in fluid communication with the reservoir, wherein the device is arranged to receive a first portion of a biological fluid in a closed system.
  • the device is capable of being sealed while maintaining a closed system after receiving the first portion of biological fluid.
  • An embodiment of a biological fluid collection arrangement comprises at least a first collection device for receiving a first portion of biological fluid, and at least one additional collection device in fluid communication with the first collection device, wherein the first and additional collection devices can be sealed, after receiving biological fluid, while maintaining a closed system.
  • a biological fluid includes any treated or untreated fluid associated with living organisms, particularly blood, including whole blood, warm or cold blood, and stored or fresh blood; treated blood, such as blood diluted with at least one physiological solution, including but not limited to saline, nutrient, additive and/or anticoagulant solutions; blood components, such as platelet concentrate (PC), platelet-rich plasma (PRP), platelet-poor plasma (PPP), platelet-free plasma, plasma, components obtained from plasma, packed red cells (PRC), transition zone material or buffy coat (BC); blood products derived from blood or a blood component or derived from bone marrow; red cells separated from plasma and resuspended in a physiological fluid or a cryoprotective fluid; and platelets separated from plasma and resuspended in a physiological fluid or a cryoprotective fluid.
  • the biological fluid may have been treated to remove some of the leukocytes before being processed according to the invention.
  • blood product or biological fluid refers to the components described above, and to similar
  • a “unit” is the quantity of biological fluid from a donor or derived from one unit of whole blood. It may also refer to the quantity drawn during a single donation.
  • the volume of a unit varies, the amount differing from donation to donation.
  • the Figures illustrate embodiments of a closed biological fluid processing system 100 in accordance with the present invention.
  • the exemplary illustrated embodiments of the system 100 include a needle or cannula 1 (shown with a removable needle cover), a first biological fluid collection device 200 for receiving a first portion of a biological fluid, a container 30 such as a blood bag for receiving a second portion of a biological fluid, wherein a plurality of conduits 2, 4, 5 and 8, and at least one connector 3, allow fluid communication between the components of the system.
  • the illustrated embodiments of the system 100 include at least four flow control devices 6, 66, 66 A, and 666.
  • the biological fluid collection device 200 comprises at least one reservoir 20, at least two conduits 5, and 8, and also includes a needle or cannula 21, e.g., for penetrating the seal of a sampling device such as a vacutainer.
  • the needle or cannula 21 is shown with a removable cover.
  • the needle or cannula 21 is inserted into a sampling device, and at least some volume of the first portion of biological fluid is passed into the sampling device.
  • the system includes a biological fluid collection arrangement comprising first and second biological fluid collection devices 200, 200A in series, the first collection device 200 comprising at least one reservoir 20, and at least one conduit 5, and the second collection device 200A comprising at least one reservoir 20 A, having side walls 23, a reservoir cover or cap 22 (e.g., a removable cover for allowing access to the portion of biological fluid collected in the collection device), wherein the device 200 A also includes at least one conduit 8.
  • a biological fluid collection arrangement comprising first and second biological fluid collection devices 200, 200A in series, the first collection device 200 comprising at least one reservoir 20, and at least one conduit 5, and the second collection device 200A comprising at least one reservoir 20 A, having side walls 23, a reservoir cover or cap 22 (e.g., a removable cover for allowing access to the portion of biological fluid collected in the collection device), wherein the device 200 A also includes at least one conduit 8.
  • first collection device 200 containing the first portion of biological fluid is sealed (e.g., conduit 5 is clamped and/or heat sealed)
  • at least some of the volume of the biological fluid is passed from first collection device 200 (e.g., from reservoir 20) into second collection device 200A, and conduit 8 is sealed while maintaining a closed system.
  • cover 22 is removed, and at least some volume of the biological fluid is withdrawn from second collection device 200A for analysis. If desired, at least some volume of the biological fluid is withdrawn from first collection device 200 for analysis.
  • the system can include additional elements such as, but not limited to, additional containers, conduits, and connectors.
  • the system includes at least one additional container and conduit.
  • the system can be included as part of any suitable biological fluid processing set.
  • the illustrated embodiments of system 100 show optional additional elements (connected to container 30 via partially dotted lines), e.g. , conduits 9-13, containers 31-33, and connectors 34 and 35.
  • the first and second portions of the biological fluid are collected while maintaining a closed system.
  • the term "closed” refers to a system that allows the collection and processing (and, if desired, the manipulation, e.g., separation of portions, separation into components, filtration, storage, and preservation) of biological fluid, e.g., donor blood, blood samples, and/or blood components, without the need to compromise the integrity of the system.
  • a closed system can be as originally made, or result from the connection of system components using what are known as "sterile docking" devices. Illustrative sterile docking devices are disclosed in U.S. Patent Nos. 4,507,119, 4,737,214, and 4,913,756.
  • the components of the system may be constructed of any suitable material, and a wide variety of suitable materials are known in the art. Typically, the components are constructed from materials that are compatible with biological fluids and sterilization protocols. In a preferred embodiment, at least one of the components is compatible with heat-sealing protocols.
  • the collection device reservoirs 20, 20A, the containers 30-33, the conduits 2, 4, 5, and 8-13, and the cap 22, are made from plasticized materials, e.g., plasticized poly vinyl chloride (PVC).
  • PVC plasticized poly vinyl chloride
  • Exemplary plasticized PVC materials include, but are not limited to, PVC plasticized with dioctylphthalate (DOP), diethylhelxylphthalate (DEHP), or trioctyltrimelliate (TOTM).
  • DOP dioctylphthalate
  • DEHP diethylhelxylphthalate
  • TOTM trioctyltrimelliate
  • at least one collection device reservoir can be substantially flexible, e.g., it can collapse or deform when the reservoir is empty and is unsupported by external means.
  • the reservoir 20 shown in Figures 1 and 2 can be substantially flexible.
  • at least one reservoir can have sufficient rigidity that it does not collapse or deform when the reservoir is empty and is unsupported by external means.
  • at least a portion of the reservoir, e.g., a side wall
  • the side walls 23 of reservoir 20A shown in Figure 2 can be resilient, and the reservoir can have sufficient rigidity that it does not collapse when empty.
  • the term "resilient" refers to the property of springing back, e.g., to regain, either fully, or approximately, an original position or shape after having been deformed, e.g., bent, stretched, or compressed.
  • the reservoir comprises a container having a plurality of side walls, or a continuous side wall, at least one wall (or a portion thereof) "springs back" to its previous position or shape after compression.
  • the reservoir comprises a container including a resilient end wall such as the bottom wall (or a portion thereof) that "springs back" to its previous position or shape after compression.
  • the process of the wall springing back to its previous position creates a negative differential pressure in the reservoir, and this causes fluid to enter the reservoir.
  • the reservoirs 20, 20A, as well as the containers 30-33, can be of any suitable size and shape.
  • the reservoirs 20 and 20A are suitable for containing at least about 3 ml of biological fluid, e.g. , in the range of from about 5 ml to about 50 ml, or more. In one preferred embodiment, at least one reservoir is suitable for containing about 20 ml to about 40 ml of biological fluid. In some embodiments including a plurality of reservoirs, at least one of the more upstream reservoirs (e.g., the reservoir(s) receiving biological fluid before the downstream reservoir(s) receive the fluid), has a larger volume than the more downstream reservoir. In some embodiments, containers 30-33 are commercially available flexible blood bags.
  • the system can include at least one connector, and typically includes a plurality of connectors.
  • the system 100 includes at least three connectors, 3, 34, and 35, that each have at least three branches, e.g., the connectors can be in the form of Y- or T-connectors. Suitable connectors are known in the art.
  • the system can include one or more flow control devices such as a clamp, seal, valve, transfer leg closure, or the like.
  • the system includes a plurality of flow control devices, and they can be located within or on the conduits, the containers and/or the needles or the cannulas.
  • the Figures illustrate embodiments having showing a plurality of flow control devices wherein flow control device 6 comprises an in-line valve in conduit 4, and flow control devices 66 and 66 A comprise clamps on conduits 5 and 8 respectively.
  • the Figures also illustrate flow control device 666 comprising an in-line valve in a port in container 30.
  • Other arrangements and types of flow control devices are also suitable.
  • flow control device 66 comprises an in-line valve in conduit 5 and/or a flow control device is interposed between connector 3 and needle 1.
  • flow control devices preferably a plurality of flow control devices, can be especially desirable for those embodiments where it is preferred that the first portion of biological fluid be prevented from contacting another fluid such as, for example, an anticoagulant, wherein the other (e.g., non-biological) fluid is contained in the system (e.g., in conduit 4 and/or container 30).
  • conduit 4 can prevent anticoagulant in conduit 4 or container 30 from passing into the portion of the conduit between the control device (e.g., device 6) and connector 3 , thus preventing anticoagulant from reaching conduits 2 and 5 while the system is being transported or otherwise handled. Accordingly, when biological fluid is subsequently introduced into the system, there is no residual anticoagulant (or essentially no residual anticoagulant) in conduit 2 and/or 5 that could contact the first portion of biological fluid.
  • needle 1 comprises a phlebotomy needle.
  • needle 21 can also comprise a phlebotomy needle.
  • the needles 1 and/or 21 can be attached to the system as is known in the art.
  • the needles can be integrally attached, or attached via connectors, such as, for example, luer connectors.
  • the needle can be attached to a conduit 8 interposed between the needle 21 and reservoir 20 as shown in Figure 1.
  • the device 200, 200A can include a connector directly attached to a reservoir 20 and/or 20A.
  • At least one collection device does not include needle or cannula.
  • the collection device as manufactured can be closed at the distal end (i.e., the end not connected to a conduit that allows biological fluid to enter the device), and the filled reservoir can be accessed, (e.g. , via puncture, cutting, or removing a cap) before removing at least some volume of the first portion of the biological fluid from the device.
  • the second collection device 200A can include a removable cap or cover 22, for allowing access to the collected biological fluid.
  • At least one collection device can include one or more connectors, access ports, conduits, containers, and/or chambers, e.g., for ease of access to samples or subsets of the first portion of biological fluid in the device.
  • At least one collection device 200, 200 A can be arranged to provide multiple samples or subsets of the first portion of the biological fluid.
  • the system can include a biological fluid collection arrangement, comprising a plurality of collection devices, arranged in series and/or in parallel fluid communication.
  • the arrangement can include a plurality of collection devices to provide multiple samples or subsets of the first portion of the biological fluid.
  • the arrangement can include additional elements such as conduits (preferably sealable conduits) and/or connectors.
  • a first subset (e.g., the first 10 ml collected from the donor) of the first portion of biological fluid is passed into the first collection device, and a second subset of the first portion (e.g. , the next 10 ml collected from the donor) is passed into the second collection device, wherein the second subset does not pass into the first collection device.
  • a first portion of biological fluid is passed into the first device, and some volume of the first portion is passed from the first device into the second device.
  • the collection arrangement can include three or more collection devices, the arrangement can include two or more collection devices in series fluid communication and/or two or more collection devices in parallel fluid communication.
  • the collection arrangement includes a plurality of collection devices, at least two collection devices are capable of receiving biological fluid and being subsequently sealed while maintaining a closed sterile system. If desired, some or each of the additional collection devices (e.g., at least the third collection device), can be so sealed after receiving biological fluid.
  • the conduit 5 and/or the reservoir 20 can be segmented, e.g., with clamps, rings, and/or seals, to isolate samples or subsets of the biological fluid in each segment.
  • Device 200A, conduit 8 and/or reservoir 20A can be similarly segmented after receiving biological fluid.
  • the collection device 200, 200 A can include a plurality of reservoirs.
  • individual segments, collection devices, compartments and/or reservoirs can be accessed (e.g. , for testing), without compromising the sterility of the biological fluid in the other segments, devices, compartments and/or reservoirs.
  • the system 100 (as well as the collection device(s) 200, 200A) can, of course, include additional components such as, but not limited to, at least one additional conduit, container, connector, and flow control device.
  • the system includes at least one filter (including, for example, at least blood filter, for example, at least one leukocyte depletion filter and/or an inactivating agent removal filter).
  • the system includes at least one leukocyte depletion filter, e.g., for filtering red blood cells, platelet-rich-plasma, or platelet concentrate.
  • embodiments of the system include at least one of a vent (including a gas inlet and/or a gas outlet), a gas collection and displacement loop, and a drip chamber.
  • Other suitable components include, for example, a phlebotomist needle protection device.
  • FIG. 1 An exemplary embodiment of a method according to the invention can be described with reference to Figure 1, that illustrates a closed biological fluid processing system 100.
  • the system contains fluid such as anticoagulant in conduit 4 and/or in container 30.
  • needles 1 and 21 are initially capped, and flow control devices are closed before biological fluid (e.g., blood) is passed into the system 100.
  • biological fluid e.g., blood
  • a blood donor's arm is prepared for venipuncture in the usual manner, and needle 1 is uncapped and inserted into the donor's vein.
  • Flow control device 66 (if present) is opened, and the first portion of the donor's blood (likely containing bacteria from the donor's skin) is passed into collection device reservoir 20 of first collection device 200. Since flow control device 6 is closed, blood is prevented from passing into receiving container 30.
  • a fluid such as an anticoagulant is contained in the conduit 4
  • the use of flow control device 6 prevents this other fluid from contacting the first portion of biological fluid. Accordingly, the collected first portion of biological fluid in first collection device 200 is free of, or essentially free of, the other fluid.
  • the collected blood is essentially free of anticoagulant.
  • flow control device 6 is an in-line valve, or wherein the system is shipped with another type of flow control device associated with conduit 4 (e.g., near connector 3) that is closed during shipment and/or handling of the system before use
  • the first portion of blood can be collected free of anticoagulant.
  • the conduit 5 is closed (e.g., clamped, for example, using flow control device 66), and typically sealed, e.g., at location 7.
  • the conduit 5 is closed and sealed essentially simultaneously.
  • the conduit can be closed and/or sealed as is known in the art.
  • the conduit is sealed via a heat seal.
  • the second portion of biological fluid is passed into container 30, while maintaining the closed system, before further processing the first portion of biological fluid in reservoir 20.
  • flow control device 6 is opened, and a second portion of biological fluid, e.g., a unit of blood, is passed into container 30.
  • a second portion of biological fluid e.g., a unit of blood
  • This portion of blood is less likely to present a risk of significant bacterial contamination, since the greater number or increased level of bacteria associated with the donor's skin is likely to be passed with the first portion of blood into the first collection device 200.
  • the needle 1 is removed from the donor's vein, and the needle is handled as is known in the art.
  • the needle is capped and/or placed in a phlebotomist protector device.
  • the first and second portions of biological fluid are typically further processed, as will be described in more detail below after describing another embodiment of the method with reference to Figure 2.
  • Figure 2 also illustrates a closed biological fluid processing system 100, including a biological fluid collection arrangement comprising first collection device 200 and second collection device 200A (e.g., wherein second collection device 200A, connected to the system 100, is hermetically closed before use).
  • the system can contain fluid such as anticoagulant in conduit 4 and/or in container 30.
  • needle 1 is initially capped, and flow control devices 6 and 66 are closed (flow control device 66 A is also typically closed) before biological fluid, e.g., blood, is passed into the system 100.
  • the donor's arm can be prepared, needle 1 uncapped and inserted, and a first portion of biological fluid can be passed into first collection device 200, as described above.
  • conduit 5 After conduit 5 is closed, and typically sealed, as described above, at least some of the volume of the first portion of biological fluid is passed from first collection device 200 into second collection device 200A.
  • flow control device 66 A (associated with conduit 8) is opened, the opposing portions of walls 23 of reservoir 20A are compressed and released at least once (causing sterile air to pass from the reservoir 20A into reservoir 20), and some volume of the first portion of blood is passed into collection device reservoir 20A of collection device 200A. Since conduit 5 is closed, air (if present) is prevented from passing into conduit 2 (e.g., toward the donor). Additionally, since flow control device 6 is closed, blood from the donor is prevented from passing into receiving container 30.
  • the conduit 8 between the first and second devices 200 and 200 A is closed (e.g. , using flow control device 66 A), and typically sealed.
  • the second portion of biological fluid is passed into container 30, while maintaining the closed system, before further processing the first portion of biological fluid in reservoir 20A.
  • the first portion of biological fluid is further processed, e.g. , passed from the reservoir 20
  • the collection device(s) 200, 200A can be separated from the rest of the system 100, preferably without compromising the sterility and integrity of the collection devices or the rest of the system 100.
  • the closed (e.g., sealed) conduits 5 and 8 can be cut, without compromising the sterility and integrity of the collection device(s) 200 and/or 200 A or the rest of the system 100.
  • the collection devices can be separated from the rest of the system 100 before or after passing the second portion of biological fluid into the container 30. Since the collection devices can be separated from the rest of the system without compromising sterility and integrity, the collected biological fluid remains in a closed system, and the collected portion can be stored (e.g., for 2 days or more) if desired, before analysis and testing.
  • the collection devices 200 and/or 200 A can be arranged to provide multiple samples or subsets of the first portion of biological fluid.
  • at least one conduit (5 and/or 8) and/or at least one reservoir (20 and/or 20A) can be segmented, e.g., with clamps, rings, and/or heat seals, to isolate samples or subsets of the biological fluid in each segment. If desired, individual segments can be accessed (e.g., for testing), without compromising the sterility of the biological fluid in the other segments.
  • At least some volume of the first portion of the biological fluid is passed from the collection device(s) 200 and/or 200A and analyzed and/or tested.
  • the biological fluid can be stored until further use, e.g., analysis and/or testing.
  • the analysis and/or testing of the first portion of biological fluid is carried out in an open system, e.g., after passing a volume of fluid through needle 21 ( Figure 1) or after removing cap 22 ( Figure 2).
  • the first collection device 200 also includes at least one needle 21, preferably a needle suitable for penetrating the seal of a sampling device such as a vacutainer, and at least some of the volume of the first portion of biological fluid can be passed through the needle 21 into the sampling device.
  • a sampling device such as a vacutainer
  • the collection device 200 can be separated from the rest of the system 100 as described above (e.g., after heat-sealing and cutting conduit 5), and the cover over needle 21 can be removed.
  • the needle is then inserted into the sampling device as is known in the art, and at least some of the volume of the first portion of biological fluid is passed into the device.
  • the needle is disengaged after the desired volume of fluid is passed into the sampling device, and additional aliquots can be passed from the collection device (e.g., additional sampling devices can be filled) as desired.
  • At least one collection device e.g., second collection device 200 A
  • second collection device 200A lacks a needle.
  • cap 22 that can be a break off cap or a threaded cap
  • conduit 5 can be cut, and, in those embodiments wherein the wall 22 of reservoir 20 is resilient, portions of the wall can be compressed, causing fluid to be passed from the reservoir through the conduit into a container such as a test tube or cuvette.
  • a needle can be inserted into the collection device and at least one sample can be withdrawn.
  • Other protocols for obtaining volumes of the first portion of biological fluid from the collection device are also encompassed by the present invention.
  • the separated volume of the first portion of biological fluid can be analyzed and/or tested as is known in the art.
  • Illustrative analyses and tests include for example, but are not limited to, blood typing, blood component viability tests, blood component counts, serology tests, drug tests, diagnostic tests, tests for infectious diseases and/or viruses, liver enzymes.
  • Other suitable analyses and tests are known to one of ordinary skill in the art.
  • the second portion of biological fluid (in receiving container 30), that is obtained while maintaining the closed system is further processed, e.g., separated into components, stored, and/or filtered, as is known in the art.
  • the blood can be separated into components such as packed red blood cells, platelet-rich-plasma, platelet concentrate, and plasma, and any of the components can be passed through a suitable leukocyte depletion filter.
  • the biological fluid collected in container 30 can be centrifuged, flow control device 666 can be opened, and blood components of different densities can be sequentially passed along conduit 9 into one or more different containers.
  • flow control devices associated with the appropriate conduits can be operated as is known in the art, and platelet-rich-plasma (PRP) can be passed along conduits 9, 11 and 12 into container 32, leaving concentrated red cells in container 30.
  • PRP platelet-rich-plasma
  • the PRP can be further processed to form platelet concentrate (remaining in container 32) and platelet-poor-plasma, that is passed from container 32 along conduits 12 and 13 into container 33.
  • Additive solution e.g., red cell additive solution
  • the components can be leukocyte-depleted, for example, by passing them through leukocyte depletion filters interposed between the various containers, or by subsequently passing the separated components through filters.
  • embodiments of the present invention are particularly suitable for storing and pooling blood components, particularly components such as platelets, that are stored under conditions that are conducive to reproduction of bacteria.
  • a plurality of units of biological fluid can be obtained as described above, e.g., wherein the first portion of each donation is passed into a collection device, and wherein the second portion of each donation is passed into a first container.
  • the second portions can be further processed to separate one or more components of interest, e.g., platelets and/or red blood cells, and the separated components can be stored for a suitable storage period.
  • the separated components e.g., units of platelets such as platelet concentrate
  • the separated components can be pooled before or after storage.
  • EXAMPLE describes one embodiment of a method according to the invention, wherein first portions of blood are obtained in a closed system, while minimizing bacterial contamination of the remaining collected blood.
  • the system 100 which is a closed sterile system, includes a phlebotomy needle 1 with a needle cover, conduits 2, 4, 5, and 8, Y-connector 3, blood receiving bag 30, collection device 200, collection device reservoir
  • a conduit is interposed between needle 21 and reservoir 20, and provides fluid communication between the needle and the reservoir.
  • the system also includes a frangible in-line valve 6, and optional clamps 66 and 66A. Collection device reservoir 20 and blood receiving bag 30 are produced from flexible plastic films.
  • the system that contains some amount of anticoagulant in conduit 4 and blood receiving bag 30, is sterilized.
  • the valve 6, as well as clamps 66 and 66A are closed before blood is passed into the system.
  • a blood donor's arm is prepared for venipuncture as is known in the art, and the phlebotomy needle is inserted into the donor's vein.
  • Clamp 66 is opened, and clamp 66A and in-line valve 6 remain closed. Since valve 6 is closed, anticoagulant is prevented from passing into conduit 2.
  • the first portion of the donor's blood, that contains bacteria from the donor's skin (and possibly the donor's bacteria-containing skin plug) passes into collection device 200. Since valve 6 remains closed, blood does not pass into the blood receiving bag 30, and anticoagulant in the tubing 4 neither contacts the blood nor passes into the collection device 200.
  • first portion of blood i.e., about 15 ml of blood
  • clamp 66 is closed, and the tubing 5 is heat-sealed, while maintaining a closed system.
  • Valve 6 is opened, and a second portion of blood, e.g., a unit of blood, is collected into blood receiving device 30.
  • This portion of blood is less likely to present a risk of significant bacterial contamination, since the greater number of bacteria associated with the donor's skin are likely to be passed with the first portion of blood into the collection device 20.
  • the sealed collection device 200 is separated from the rest of the system 100 while maintaining the closed nature of both the device 200 and the remaining part of the system. After tubing 5 is heat sealed, the tubing is cut without compromising the seal at the ends of the tubing.
  • the needle cover over needle 21 is removed and the tip of the needle is inserted into a stoppered evacuated blood collection tube, clamp 66A is opened, and at least some volume of the first portion of the blood is passed into the tube for analysis of bacterial contamination. Additionally, at essentially the same time, a volume of the second portion of blood is analyzed for bacterial contamination.
  • the first portion of blood (from the initially collected 15 ml) is found to be contaminated with Staphylococcus epidermidis, and the second portion is not found to be contaminated with Staphylococcus epidermidis.
  • This example shows that contamination of collected blood with Staphylococcus epidermidis can be reduced by separately collecting a first portion of blood.

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  • Health & Medical Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
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Abstract

L'invention porte sur des systèmes et des procédés visant à minimiser la contamination bactérienne d'un fluide biologique, notamment en préparant une partie du fluide biologique (par exemple, pour le tester) dans un système fermé. Le système de traitement d'un fluide (100) biologique comprend un dispositif (200) de récupération du fluide permettant de recevoir une première partie d'un fluide biologique venant d'une source de fluide biologique, le dispositif pouvant être fermé hermétiquement tout en conservant un système fermé; au moins un premier réceptacle (30) recevant une seconde partie d'un fluide biologique venant de la source de fluide biologique, le dispositif de récupération de fluide biologique et le premier réceptacle étant en communication fluidique avec la source du fluide biologique.
PCT/US1999/017174 1998-08-07 1999-07-29 Systeme de traitement de fluides biologiques Ceased WO2000007642A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US9592498P 1998-08-07 1998-08-07
US60/095,924 1998-08-07

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WO2000007642A1 true WO2000007642A1 (fr) 2000-02-17

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Cited By (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2003092573A3 (fr) * 2002-05-03 2004-04-01 Gambro Inc Appareil et procede de detection de bacteries dans des produits sanguins
WO2004058067A1 (fr) * 2002-12-18 2004-07-15 Lydall, Inc. Dispositif de prelevement sanguin a systeme ferme
US7044941B2 (en) 1999-07-29 2006-05-16 Baxter International Inc. Method and apparatus for collecting blood samples prior to a blood collection procedure
US7479131B2 (en) 1999-07-29 2009-01-20 Fenwal, Inc. Biological fluid sampling apparatus, assembly and method
WO2010028638A1 (fr) * 2008-09-12 2010-03-18 Walter Pobitschka Procédé et dispositif de séparation de sang au moyen d'une centrifugeuse
FR2943532A1 (fr) * 2009-03-30 2010-10-01 Maco Pharma Sa Systemes a poches comprenant un recipient d'echantillonnage muni d'un dispositif d'ouverture
US8777921B2 (en) 2003-11-19 2014-07-15 Noble House Group Pty Ltd. Sterile sampling methods and apparatus
US9247902B2 (en) 2003-11-19 2016-02-02 Noble House Group Pty Ltd. Sterile sampling methods and apparatus
CN113260395A (zh) * 2019-01-10 2021-08-13 元细胞技术公司 用于生物流体的离体处理的容器
JP2022011541A (ja) * 2020-06-30 2022-01-17 テルモ株式会社 医療用バッグシステム及び遠心分離システム

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US2950716A (en) * 1956-01-23 1960-08-30 Fenwal Lab Inc Fluid handling method and apparatus
WO1983001573A1 (fr) * 1981-10-30 1983-05-11 Baxter Travenol Lab Systemes et procedes de prise de sang a rendement ameliore
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WO1992012684A1 (fr) * 1991-01-22 1992-08-06 Baxter International Inc. Recipient collecteur de sang comportant un reservoir d'echantillon aplati
EP0930079A1 (fr) * 1998-01-16 1999-07-21 Terumo Kabushiki Kaisha Dispositif de collection de sang

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Publication number Priority date Publication date Assignee Title
US2950716A (en) * 1956-01-23 1960-08-30 Fenwal Lab Inc Fluid handling method and apparatus
WO1983001573A1 (fr) * 1981-10-30 1983-05-11 Baxter Travenol Lab Systemes et procedes de prise de sang a rendement ameliore
US4507119A (en) 1982-07-06 1985-03-26 E. I. Du Pont De Nemours And Company Sterile docking process, apparatus and system
GB2142240A (en) * 1983-06-27 1985-01-16 Terumo Corp Blood bag apparatus
US4737214A (en) 1985-07-05 1988-04-12 NPBI Nederlands Produktielaboratorium voor Bloedtransfusieapparatuur en Infusievloeistoffen B. V. Method for providing sterile connection of plastic tubes or the like
US4913756A (en) 1987-09-22 1990-04-03 Denco, Inc. Techniques for welding thermoplastic tubes
WO1992012684A1 (fr) * 1991-01-22 1992-08-06 Baxter International Inc. Recipient collecteur de sang comportant un reservoir d'echantillon aplati
EP0930079A1 (fr) * 1998-01-16 1999-07-21 Terumo Kabushiki Kaisha Dispositif de collection de sang

Cited By (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7044941B2 (en) 1999-07-29 2006-05-16 Baxter International Inc. Method and apparatus for collecting blood samples prior to a blood collection procedure
US7479131B2 (en) 1999-07-29 2009-01-20 Fenwal, Inc. Biological fluid sampling apparatus, assembly and method
WO2003092573A3 (fr) * 2002-05-03 2004-04-01 Gambro Inc Appareil et procede de detection de bacteries dans des produits sanguins
WO2004058067A1 (fr) * 2002-12-18 2004-07-15 Lydall, Inc. Dispositif de prelevement sanguin a systeme ferme
US9247902B2 (en) 2003-11-19 2016-02-02 Noble House Group Pty Ltd. Sterile sampling methods and apparatus
US8777921B2 (en) 2003-11-19 2014-07-15 Noble House Group Pty Ltd. Sterile sampling methods and apparatus
US9238096B2 (en) 2008-09-12 2016-01-19 Walter Pobitschka Method and device for separating blood using a centrifuge
WO2010028638A1 (fr) * 2008-09-12 2010-03-18 Walter Pobitschka Procédé et dispositif de séparation de sang au moyen d'une centrifugeuse
US10391231B2 (en) 2008-09-12 2019-08-27 Walter Pobitschka Method and device for separating blood using a centrifuge
FR2943532A1 (fr) * 2009-03-30 2010-10-01 Maco Pharma Sa Systemes a poches comprenant un recipient d'echantillonnage muni d'un dispositif d'ouverture
WO2010112693A1 (fr) 2009-03-30 2010-10-07 Maco Pharma Systèmes à poches comprenant un récipient d'échantillonnage muni d'un dispositif d'ouverture
CN113260395A (zh) * 2019-01-10 2021-08-13 元细胞技术公司 用于生物流体的离体处理的容器
JP2022011541A (ja) * 2020-06-30 2022-01-17 テルモ株式会社 医療用バッグシステム及び遠心分離システム
CN115697432A (zh) * 2020-06-30 2023-02-03 泰尔茂株式会社 医用袋系统和离心分离系统

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