EP0118473A1 - Systemes et procedes de recuperation de composants du sang a rendement accru - Google Patents

Systemes et procedes de recuperation de composants du sang a rendement accru

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Publication number
EP0118473A1
EP0118473A1 EP83902661A EP83902661A EP0118473A1 EP 0118473 A1 EP0118473 A1 EP 0118473A1 EP 83902661 A EP83902661 A EP 83902661A EP 83902661 A EP83902661 A EP 83902661A EP 0118473 A1 EP0118473 A1 EP 0118473A1
Authority
EP
European Patent Office
Prior art keywords
plasma
whole blood
blood
collection
container
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.)
Withdrawn
Application number
EP83902661A
Other languages
German (de)
English (en)
Other versions
EP0118473A4 (fr
Inventor
Peter A. Bloom
Ronald A. Williams
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.)
Baxter International Inc
Original Assignee
Baxter Travenol Laboratories Inc
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 Baxter Travenol Laboratories Inc filed Critical Baxter Travenol Laboratories Inc
Publication of EP0118473A1 publication Critical patent/EP0118473A1/fr
Publication of EP0118473A4 publication Critical patent/EP0118473A4/fr
Withdrawn legal-status Critical Current

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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
    • A61M1/34—Filtering material out of the blood by passing it through a membrane, i.e. hemofiltration or diafiltration
    • A61M1/3496—Plasmapheresis; Leucopheresis; Lymphopheresis
    • 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
    • A61M1/36—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
    • A61M1/3693—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits using separation based on different densities of components, e.g. centrifuging

Definitions

  • This invention generally relates to systems and methods which enable the collection and separation of whole blood into its therapeutic components.
  • This invention also generally relates to whole blood collection and separation systems and methods which enable the storage of whole blood and its various therapeutic components for the maximum allowable periods.
  • This invention also generally relates to ⁇ emiperrrieable membrane systems and methods.
  • red blood cells which can be used to treat chronic anemia
  • cryoprecipitate which is rich 5 in Clotting Factor VIII (also known as AHF) and can be used to treat hemophilia
  • plasma which can be used to restore all of the clotting factors to patients
  • platelets which can be used to treat thrombocy openia
  • numerous other 0 plasma-based fractions such as albumin, protein fraction, gamma globulin, and various other specific coagulation protein concentrates.
  • OMP One desirable feature for a blood collection and separation system and method is the capability to maximize, to the greatest extent possible, the yield of clinically proven blood components during a single collection procedure.
  • the importance of this feature stems in large part from the traditionally limited number of individuals who volunteer to donate whole blood- on a regular basis.
  • the importance of this feature also stems from the periodic nature of blood collection procedures themselves. In the United States, for example, a collection of one unit of whole blood (approximately 450 milliliters) from an individual volunteer donor for separation into its various components can be undertaken only once every 8 weeks if the red cells are retained for storage.
  • CTitle 21 C.F.R. ⁇ 640.16(b)J define a "closed” bloo collection system as one in which the initially sterile'blood collection and transfer containers are integrally attached to each other and not open to communication with the atmosphere. Furthermore, to remain a "closed” blood collection system in the United States, the blood collection container of the system cannot be “entered” in a non-sterile fashion after blood collection. By present United States standards, an entry into a blood collection system which presents the probability of non-sterility which exceeds one in a million (i.e., greater than 10- ) constitutes a "non-sterile" entry. A non-sterile entry "opens" a heretofore "closed” system and dictates the significantly shortened storage periods for the blood and components collected and processed within the system.
  • all of the above-identified blood collection assemblies rely upon non-automated batch centrifugation to separate the collected unit of whole blood into various components.
  • the collected unit of whole blood is first centrifugally separated within the original collection container into platelet-rich plasma and red blood cells.
  • the 5 platelet-rich plasma is then transferred into another container which is integrally attached to the original collection container for further centrifugal separation into platelet-poor plasma and platelets.
  • Batch centrifugation is normally done at
  • CS-3000® Blood Cell Separator which is manufactured and sold by Fenwal Laboratories.
  • Continuous flow processing systems typically require the use of relatively expensive, large, and sophisticated centrifugation machines. These machines are not suited for easy transport from one collection site to another, and are usually installed only at central blood processing facilities- They are simply not available to boost the yields of mobile blood collection units.
  • the donor In both non-automated batch processing and automated "continuous flow" processing, the donor is required to be present virtually throughout the entire collection and separation procedure. The period of time a person must spend in order to donate blood cannot help but bear upon that person's willingness to regularly donate blood in the first place.
  • one of the principal objects of this invention is to provide blood collection systems and methods which maximize, to the greatest extent possible, the yield of blood components obtained during a single collection procedure in a manner which also assures the maximum available storage period for each of the components collected, as measured by applicable United States standards.
  • Another principal object of this invention is to provide blood collection systems and methods which are compact and easily handled and which can be efficiently manufactured, stored, and utilized by the operator, particularly at remote collection sites away from the central processing facility.
  • Yet another one of the principal objects of this invention is to provide blood collection systems and methods which, in addition to the just described attributes, do not depend entirely upon costly, relatively large, and sophisticated processing devices which cannot be easily transported to a remote collection site.
  • Still another of the principal ojects of this invention is to provide blood collection systems and methods which seek to minimize, to the greatest possible extent, donor time during a given procedure.
  • the invention provides increased yield blood collection systems and methods which maximize, to the greatest extent possible, the yield of blood components obtained during a single collection procedure in a manner which also assures the maximum permissible storage period for each of the components collected.
  • a system which embodies the features of the invention includes first means for establishing a flow of whole blood from a donor and second means for separating the whole blood into essentially plasma and plasma—poor components without using a centrifugation device.
  • the system also includes third means for collecting a volume of the separated plasma and fourth means for returning the plasma-poor components associated with this collected volume of separated plasma to the donor.
  • the system further includes means for collecting a volume of whole blood.
  • the second means includes microporous membrane means which is operative for filtering the plasma from the other components of whole blood.
  • the fifth means includes means for collecting the components of the whole blood in response to subsequent centrifugal separation.
  • the total volume of components which can be collected using the system during a given procedure will depend upon the physiology of the donor and the maximum allowable total volumes permitted by governing regulations. However, using the system, a blood collection facility is able to significantly
  • OMPI increase its plasma yields during each collection procedure over the plasma yields obtained using conventional non-automated batch centrifugation techniques. Furthermore, and significantly, the system achieves its increased component yields without reliance upon relatively complicated and sophisticated "continuous flow" centrifugal devices. For example, only a conventional peristaltic pump is necessary to initially separate the plasma from the red cells and return the plasma-poor comonents to the donor, and only non-automated batch centrifugation equipment is required to later separate the collected volume of whole blood into additional components.
  • the elements of the system are integrally connected together and offer interconnecting fluid paths which are closed from communication with the atmosphere. The system , thus constitutes a "closed" system, as judged by applicable standards in the United States. Thus, all of the components which are collected are suited for maximum allowable storage periods.
  • each of the collection means is imparted with a predetermined physical characteristic which is beneficial to the long-term storage of the particular blood component collected.
  • a method which embodies the features of the invention includes the steps of establishing a flow of whole blood from the donor and noncentrifugally separating the whole blood into essentially plasma
  • the method further includes the steps of collecting a volume of the separated plasma, while continuously returning the associated plasma-poor components to the donor.
  • the ⁇ method further includes the step of collecting a volume of whole blood.
  • the unit of whole blood is subsequently separated into its components using batch centrifugation methods.
  • the step of collecting the unit of whole blood occurs after the step of collecting the filtered plasma.
  • the donor is required to be present only during the collection of the volume of plasma and the unit of whole blood.
  • the subsequent separation of the whole blood into its various components can occur without the presence of the donor. Donor time during this extended yield procedure is thus minimized to the greatest extent possible.
  • Another system and associated method which embody the features of the invention employ, like the system and method heretofore described, first means for establishing a flow of whole blood from a donor and second means for noncentrifugally separating the whole blood into essentially plasma and plasma-poor components.
  • this embodiment of the system' and method employ third means for collecting a volume of the separated plasma.
  • this system and method employ means for collecting a volume of the
  • OMPI plasma-poor components associated with the collected volume of plasma.
  • the system and method further employ fourth means for returning the remaining volume of the plasma-poor components to the donor.
  • the just-described system and method enables the collection, during a single procedure, of upwards to 320 milliliters of the plasma-poor components (notably, packed red blood cells having approximately a 60 hematocrit), and upwards to 555 milliliters of plasma.
  • the total volume of components collected will depend upon the physiology of the donor as well as applicable maximum allowable volumes dictated by governing regulations. Nevertheless, the system and method provides increased overall plasma yields, compared to conventional non-automated batch centrifugation techniques.
  • the system and method requires only a peristaltic pump to perform the entire collection procedure.
  • the system and method are thus extremely mobile and suited for use at remote collection facilities.
  • the foregoing system preferably constitutes a closed system, and all of the components which are collected are suited for maximum allowable storage periods. Also as before, each of the collection means is preferably imparted with a predetermined physical characteristic which is beneficial to the long-term storage of the particular blood component collected.
  • all or some of the collection means comprise physically separate entities which can be separately manufactured, stored, and transported, and which can be selectively joined to form the required system at the collection site, all without compromising the sterile integrity of any of the collection means or the formed system as a whole.
  • Fig. 1 is a functional diagrammatic view of an increased yield blood component collection system which embodies the features of the invention
  • Fig. 2 is a functional block diagrammatic view of a method which utilizes the increased yield blood component collection system shown in Fig. 1 and which embodies the features of the invention;
  • Fig. 3 is a functional diagrammatic view of another increased yield blood component collection system which embodies the features of the invention.
  • Fig. 4 is an enlarged side view, with portions broken away and in section, of the microporous membrane device which is associated with the system shown in Figs. 1 and 3;
  • Fig. 5 is an end section view, with a portion broken away and in section, of the microporous membrane device taken generally along line 5-5 in Fig. 4;
  • Fig. 6 is a functional block diagrammatic view of a method which utilizes the increased yield blood component collection system shown in Fig. 3 and which embodies the features of the invention;
  • PI Fig. 7 is a plan view of yet another increased yield blood component collection system which embodies the features of the invention.
  • Fig. 8 is an enlarged view of a portion of the increased yield collection system shown in Fig. 7;
  • Fig. 9 is a further enlarged' view, with portions broken away and in section, of a portion of the system shown in Fig. 7, showing the connector means associated with the system in an uncoupled relationship;
  • Fig. 10 is an enlarged view, with portions broken away and in section, of the connector means shown in Fig. 9 in a coupled relationship and being exposed to a radiant energy-induced melting apparatus to open a fluid path therethrough;
  • Fig. 11 is an enlarged view, with portions broken away and in section, of the connector means shown in Fig. 10 after the fluid path has been opened therethroug .
  • FIG. 1 An increased yield blood component collection system 10 is shown in Fig. 1.
  • the system 10 includes first means 12 for establishing a flow of whole blood from a donor and second means 14 for separating the whole blood into essentially plasma and plasma-poor components (which can include red blood cells, leucocytes, and platelets).
  • the system 10 further includes third means 16 for collecting a volume of the separated plasma and fourth means 18 for returning the plasma-poor components which are associated with the collected volume of separated plasma to the donor.
  • the system 10 further includes fifth means 20 for collecting a volume of whole blood.
  • the second means 14 is operative for separating the whole blood without using centrifugal separation techniques.
  • Noncentrifugal separation techniques include membrane filtration, glass filtration, and depth filtration, as well as the use of absorption columns, chemical separation, and electrical separation.
  • the second means 14 includes microporous membrane means 22 which is operative for separating the plasma from the other components of whole blood (i.e., the plasma-poor components heretofore identifie ).
  • the microporous membrane means 22 may be variously constructed. In the illustrated embodiment, and as best shown in Figs. 4 and 5, the
  • membrane means 22 includes a tubular housing 24 in which a bundle of microporous hollow fiber membranes
  • the membranes 26 are mounted.
  • the membranes 26 are preferably mounted within the housing 24 utilizing conventional potting techniques, such as the one disclosed in Mahon, U.S. Patent 3,228,876.
  • a liquid potting compound 28, typically polyurethane, is introduced into opposite ends of the housing 24 to impregnate the exterior areas of the membranes 26 about and between the ends
  • end caps 30 and 32 may be sealed to the potted ends of the housing 24.
  • An inlet port 31 is formed on the end cap 30, and an outlet port 33 is formed on the other end cap 32.
  • Circumferentially surrounding the bundle of hollow fiber membranes 26 is an open volume 34 (see Fig. 4) which is sealed at each end by the cured potting compound 28.
  • An outlet port 36 communicates with the volume 34.
  • thermoplastic polymers such as polypropylene.
  • These materials can be formed into hollow fibers by known processes such as solution spinning or melt spinning.
  • a polypropylene hollow fiber can be manufactured which has a wall thickness of approximately 150 microns, an interior diameter of approximately 320 microns, a maximum pore size of approximately .55 microns, and an average pore size of approximately .30 microns.
  • Such a hollow fiber is commercially available from Enka AG, the Federal Republic of Germany, and is well-suited for the purposes herein described.
  • the membrane means 22 can take the form of a device having spaced-apart, generally planar membranes made of the.-same or comparable microporous material.
  • An example of such a device is disclosed in ⁇ delman et al, U.S. Patent 4,313,813.
  • the system 10 includes conduit means 38 which establishes a plurality of interconnected fluid paths, each of which is preferably integrally connected with its associated element of the system 10 and is thereby closed from communication with the atmosphere.
  • the "closed" embodiment of the system 10 is preferred, because it permits the storage of the collected components for the maximum allowable time. However, it should be appreciated that the system 10 could be "open” and operate in the same fashion, except that the plasma collected could be used only for fractionation purposes (which includes a subsequent sterilization step), and the collected unit of whole blood and its components would have to be reinfused within twenty-four (24) hours.
  • the portion of the conduit means 38 associated with the first means 12 includes first branch means 40.
  • the first branch means 40 takes the form of a length of flexible tubing made of hemocompatible material, such as plasticized polyvinyl chloride, which communicates, at one end, with the inlet port 31 of the membrane means 22 and, at the other end, with a phlebotomy needle 42.
  • the first branch means 40 includes a portion 41 which is capable of being operatively connected with external pump means 44 to introduce whole blood from the donor into the membrane means 22.
  • the pump means 44 may be variously constructed. However, in order to meet all of the collection objectives of the system 10 (which includes extended storage times), operative contact . between the tubing portion 41 and the pump means 44 must not compromise the sterile integrity of, or otherwise "open", the system 10, as judged by applicable standards in the United States.
  • the pump means 44 takes the form of a conventional peristaltic pump, such as one manufactured and sold by Renal
  • the pump 44 serves to repeatedly compress and expand the tubing portion 41 and causes whole blood to flow from the donor through the first branch means 40 and into the hollow fibers 26.
  • the pressure at the inlet port 31 of the membrane means 22 can be maintained to provide the proper flow characteristics within the hollow fiber membranes 26 to cause effective separation of the plasma from the rest of the components of the whole blood without hemolysis.
  • the desired flow conditions are disclosed, for example, in Blatt et al, U.S. Patent 3,705,100.
  • the plasma-poor components essentially consisting of red blood cells, leucocytes, and platelets exit the outlet port 3.3.
  • the conduit means 38 further includes second branch means 46 which takes the form of a length of flexible hemocompatible tubing communicating with the plasma filtrate volume 34 and the plasma collection means 16.
  • the plasma collection means 16 includes one or more flexible containers or bags 48, hereafter referred to as the first collection container.
  • the second branch means 46 is integrally connected with the first collection container or containers 48. The second branch means 46 is thus operative for- transferring the plasma filtrate from the volume 24 into the first container 48.
  • the conduit means 38 which is associated with the return means 18 includes third branch means 50 for returning the plasma-poor components exiting the membrane means 22 to the donor.
  • the third conduit means 50 takes the form of a length of flexible hemocompatible tubing which communicates, at one end, with the outlet port 33 of the membrane means 22 and, at the other end, with another phlebotomy needle 52.
  • Each phlebotomy needle 42 and 52 may be integrally connected to the respective branch conduit means 40 and 50 and be normally closed from communication with the atmosphere by a conventional needle cover 54 or sheath (not shown in Fig. 1, but shown in the embodiment shown in Fig. 4).
  • each branch conduit means 40 and 50 can include a conventional needle adaptor (not shown) to receiye the needles 42 and 52 at the time - venipuncture is desired.
  • a needle adaptor is one utilized in FENWAL® Blood Recipient Sets sold by Fenwal Laboratories.
  • first and third branch means 40 and 50 could communicate in common with a single, multiple lumen needle of conventional construction (not shown) .
  • the conduit means 38 associated with the whole blood collection means 20 includes fourth branch means 56 which takes the form of a length of flexible hemocompatible tubing communicating"with the first branch means 40 upstream of the membrane means 22.
  • the fourth branch means 56 is thus operative for diverting whole blood away from the membrane means 22 and into the whole blood collection means 20 of the system 10.
  • the remainder of the whole blood collection means 20 may be variously constructed.
  • the collection means 20 includes a primary container 58 (hereafter referred to as the second collection container) integrally attached to the fourth branch means 56.
  • the collection means 20 also preferably includes at least one transfer container 60 which is integrally attached in fluid communication with the second collection container 58.
  • the transfer container 60 or containers enable the whole blood collected in the second collection container 58 to be sequentially processed using conventional batch centrifugation methods into its various components, such as red blood cells, platelets, and platelet-poor plasma.
  • the number of transfer containers 60 associated with the second collection container 58 can vary according to the collection objectives of the system 10. In the illustrated embodiment, two transfer containers 60 are shown, one (designated 60a) to store platelets, and the other (designated 60b) to store platelet-poor plasma. The remaining red cells are retained in the second collection container 58 for storage.
  • the system 10 also includes an integrally attached source 62 of a sterile anticoagulant solution and an integrally attached source 64 of a sterile saline solution.
  • the conduit means 38 includes fifth branch means 66 which takes the form of a length of flexible hemocompatible flexible
  • the fifth branch means 66 is thus operative for introducing the anticoagulant solution * into the system 10 to prevent the donor • s blood from clotting during the course of the procedure.
  • a peristaltic pump (not shown) may be used to meter the introduction of the anticoagulant solution. Also in this arrangement, the conduit means
  • the 38 includes sixth branch means 68 which takes the form of a length of flexible hemocompatible tubing integrally connected with the saline source 64 and the first branch means 40 upstream of the pump means 44.
  • the sixth branch means 68 is operative for introducing saline into the system 10 to purge air from the system 10 prior to the procedure and to wash components from the system 10 after the procedure.
  • the source 62 of anticoagulant solution includes a bag 70 made of a plasticized polyvinyl chloride material or the like which contains the sterile anticoagulant.
  • a suitable overwrap 72 is provided to prevent evaporation of the saline from the bag 70 during storage.
  • the fifth branch means 66 is integrally connected with the bag 70 and extends (via a drip chamber 74) to integrally join the first branch means 40 upstream of the pump means 44.
  • the source 64 of sterile saline likewise includes a bag 76 having a suitable overwrap 78.
  • the sixth branch means 68 is also integrally connected with the bag 56 and proceeds (via another drip chamber 80) to join the first branch means 34 upstream of the pump means 44.
  • the sixth branch means 68 can include a vent passage 69 communicating with the third branch means 50.
  • the vent passage 69 is also integrally connected with the saline bag 76. This passage 69 recirculates the saline used to prime the system 10 back into the saline bag 76.
  • the system 10 can optionally include a third collection container 84 (shown in phantom lines in Fig. 1) communicating with the third conduit means 42 via an integrally connected vent passage 85 (also shown in phantom lines).
  • the third collection container 84 collects the volume of saline used to prime the system 10.
  • valve means 86a, b, c, d, e, f, and g is provided inline with, respectively, the first; second; third; fourth; fifth; and sixth branch means (respectively 40; 46; 50; 56; 66; and 68), and each of the Optional vent passages 69 or 85.
  • Each of the valve means 86 is preferably a manually operable clamping mechanism, such as a roller clamp or a hemostat. Attention is now directed to Fig. 2, in which a method hich embodies the features of the invention and which can utilize the system 10 as heretofore described is shown.
  • the method includes the step of drawing whole blood from the donor for separation by filtration or other noncentrifugal technique into essentially plasma and plasma-poor components (notably, red blood cells).
  • the platelet-poor components C n also include platelets and leucocytes.
  • a volume of plasma is collected, and the red blood cells (and any associated platelets and leucocytes) which were associated with the collected volume of separated plasma, are returned to the donor.
  • the method also includes the step of collecting a volume of whole blood from the donor. Preferably, in the interest of minimizing the donor's time, this unit of whole blood is collected after the volume of plasma. After this whole blood collection step, the donor's presence is no longer required. The collection procedure, per se, can thus be terminated as is shown in Fig. 2.
  • the method further includes the step, after the collection procedures have been terminated, of separating the collected volume of whole blood into other blood components such as red *. blood cells, platelet-poor plasma, and platelets.
  • the whole blood components are separated utilizing conventional batch centrifugal separation.
  • all of the steps are performed in a manner which does not expose the whole blood, the returned red cells, and the collected volumes of components of whole blood to communication with the atmosphere. Maximum permissible storage times for . the collected components can thus be achieved.
  • the blood collection system 10 shown in
  • Fig. 1 can perform the just described method (shown in Fig. 2) as follows.
  • the system 10 can be suitable primed with saline. The venipunctures can then be made.
  • the valve means 86d (associated with the whole blood collection means 20) is preferably closed at this point in the procedure.
  • the plasma is separated from the whole blood.
  • the plasma collects in the volume 34.
  • the valve means 86b associated with the second branch means 46 is opened, the plasma can be collected'into the first collection container 48 or container.
  • the plasma-poor components exit the membrane means 22 and proceed, via the third branch means 50, back to the donor.
  • the portion of the system 10 and method just-described constitute a "continuous flow" blood processing system and method. This is because whole blood from the donor is continuously being circulated into and through the membrane means 22. The plasma is continously being collected in the first container 48 up to a desired volume, and the remaining plasma-poor components are continuously being returned to the donor.
  • valve means 86b and 86c associated, respectively, with the second and third branch means 46 and 50 can be closed and the valve means 86d associated with the fourth branch means 56 can be opened to divert a volume of whole blood into the second collection container 58.
  • the collection procedure can be terminated.
  • the second collection container 58 and integrally attached transfer containers- 60 can then be next separated from the system 10, using a spaced apart pair of hand seal clips (not shown), or by the ⁇ formation of a hermetic, snap-apart seal using a
  • HEMATRON® dielectric sealer (also not shown) sold by Fenwal Laboratories.
  • the separated unit can then undergo batch centrifugation as heretofore described.
  • the total volume of components which can be collected utilizing the system shown in Fig. 1 or the method illustrated in Fig. 2 will depend upon the physiology of the donor as well as the maximum allowable volume limits prescribed by applicable governing regulations. For example, in the United States, the maximum allowable volume limit is approximately 770 milliliters of plasma (which includes approximately 50 milliliters of a sodium citrate anticoagulant) for donors weighing less than 175 pounds, and approximately 925 milliliters of plasma (again including approximately 50 milliliters of sodium citrate anticoagulant) for donors weighing 175 pounds or more.
  • the system and method are capable of collecting from a healthy donor weighing less than 175 pounds approximately 270 milliliters of plasma (including anticoagulant volume) and approximately 500 milliliters of whole blood (including anticoagulant volume) .
  • the system and method are capable of collecting approximately 425 milliliters of plasma (including anticoagulant volume) and approximately 500 milliliters of whole blood (including anticoagulant volume) during a given procedure.
  • the whole blood collected can be further sequentially processed into an additional volume of platelet-poor plasma, a volume of platelets, and a unit of packed red blood cells.
  • system 10 requires only a single peristaltic pump 44 and 'conventional batch centrifugation techniques to achieve its increased yield objectives.
  • the system 10 thus is not dependent upon large and technologically sophisticated continuous flow centrifugal blood processing devices.
  • the system 10 as a whole constitutes, after sterilization, a closed system, as judged by applicable standards in the United States. This allows the maximum, permissible storage times for each of the components collected. o further enhance the storage of the components collected by system 10, at least a portion of the first and second collection containers 48 and 58, as well as the transfer containers 60, is purposely imparted with a predetermined physical characteristic which is beneficial to the intended storage function of the containers 48, 58, 60. More particularly, to maximize the storage times of components collected by the system 10, the plasma collection container 48 and the plasma transfer container 60b are each is preferably made of a material having a relatively high low-temperature strength to withstand freezing of the • plasma for prolonged storage.
  • Candidate materials for this purpose includes various polyolefin materials, such as low density polyethylene and copo ' lymers of polyethylene and polypropylene, including those containing a major amount of polypropylene.
  • the second collection container 58 is preferably made of a material which is known to suppress hemolysis in red cells during storage.
  • Candidate materials for this purpose include polyvinyl chloride plasticized with . di-2-ethylhexylphthalate (DEHP) .
  • DEHP di-2-ethylhexylphthalate
  • an additional transfer container 60c can communicate with the second collection container 58.
  • This transfer container 6oc includes an isotonic red cell storage solution (designated "S" n Fig. 1) which is suited for suppressing hemolysis during storage.
  • the solution S could include ingredients such as saline, adenine, mannitol, and glucose, such as the solution disclosed in Grode et al, U.S. Patent 4,267,269, or in copending Grode et al, U.S. Patent Application No. 377,110, filed May 11, 1982, and entitled RED CELL STORAGE SOLUTION AND METHOD.
  • the transfer container 60a in which platelet concentrate will ultimately be stored preferably has a gas transfer characteristic beneficial to prolonged platelet storage. More particularly, the transfer container 60a would preferably have a gas transfer characteristic which exceeds that of polvinyl chloride plasticized with di-2-ethylhexylphthalate (DEHP).
  • the transfer container 60a can include a polyolefin-type container which is disclosed in Gajewski et al, U.S. Patent 4,140,162, or a polyvinyl chloride container which has been plasticized with tri-2-ethylhexyl trimellitate
  • TSHTM Time Warner et al, U.S. Patent 4,280,497.
  • the platelet • transfer container 60a can include a platelet storage media (not shown) which is suited for maintaining platelet viability during storage.
  • the system 11 shares many common features of the system 10 shown in Fig. 1 and heretofore described. Common components are assigned the same reference numerals as in the system 10 shown in Fig. 1.
  • the system 11 includes microporous membrane.means 22 as heretofore described.
  • the system 11 also includes the associated branch conduit means 40; 46; 50; 66; and 68.
  • the first branch conduit means 40 includes the portion 41 which can be operatively connected with the appropriate pump means 44.
  • the system 11 be "closed” to obtain the maximum permissible storage periods.
  • the counterpart of the second collection container (which is identified with the numeral 59 in Fig. 3) is situated downstream of the microporous membrane means 22 in fluid communication with the third branch means 50 via branch conduit means 57.
  • the branch conduit means 57 diverts the plasma-poor components tnotably, the red blood cells) away from the donor and into the second collection container 59.
  • Fig. 6 a method which embodies the features of the invention and which can utilize the system 11 shown in Fig. 3 is illustrated.
  • the method includes the steps of establishing a flow of whole blood from the donor for noncentrifugal separation (using the membrane means 22) into essentially plasma and plasma-poor components (which include red blood cells, platelets, and leucocytes), as heretofore described. Also as heretofore described, a volume of separated plasma is collected (in the first collection container 48) .
  • Fig. 2 in the method shown in Fig.
  • a volume of the plasma-poor components (notably, the red blood cells) associated with the collected volume of separated plasma is also collected (in the second collection container 59), with the remaining volume of the. ; plasma—poor components being returned to the donor.
  • a transfer container 61a (shown in phantom lines in Fig. 3) can be integrally attached to the second collection, container 59 to additionally collect by various means (such as by washing) the platelets associated with the red blood cells collected in the container 58.
  • the system 11 shown in Fig. 3 can be utilized to perform this method following generally the same sequence as described with the collection procedure associated with the system 10 shown in Fig. 1.
  • utilizing the system 11 to perform the method shown in Fig. 6 can result in increased yields the total volume of which ultimately depends upon the physiology of the donor as well as the maximum allowable limits prescribed by governing regulations.
  • the system 11 is capable of collecting, from donors weighing less than 175 pounds, approximately 450 milliliters of plasma in the first collection container 48 and approximately 320 milliliters of packed red cells, having a hematocrit of about 60, in the second collection container 59; and, from donors weighing 175 pounds or more, approximately 600 milliliters of plasma and aproximately 320 milliliters of packed red cells (also having a hematocrit of about 60).
  • first and second collection containers 48 and 59, and the optional transfer container 61a may each be purposely imparted with a physical characteristic which is beneficial to its intended storage function.
  • the system 88- shares many common features of the systems 10 and 11 heretofore described, and is capable of being selectively configured either as system 10 or system 11. Common components are assigned the same reference numerals.
  • the system 88 includes microporous membrane means 22 as heretofore described.
  • the system 88 also includes the same associated branch conduit means 40; 46; 50; 56? 57; 66; and 68.
  • the first branch means 40 includes the portion 41 which can operatively connected with the appropriate pump 44 (not shown in Fig. 7). '
  • the first and second collection containers 48 and 58 (in the Fig. 1 system 10) or 59 (in the Fig. 3 system 11), as well as the anticoagulant and saline bags 70 and 76 are also provided.
  • the containers 48, 58, and 59 as well as any associated transfer containers 60 or 61 may each'be purposely imparted with a physical characteristic which is beneficial to its intended storage function in the manners heretofore described.
  • the priming volume of saline can be vented from the system 88 in any manner heretofore described. However, in the system 88 shown in Fig. 7, venting conduit 69 is utilized.
  • the needles 4.2 and 52 are each integrally connected to the associated branch means 40 and 50. Each is normally sealed from communication with the atmosphere by a needle cover 54, which is removed at time of venipuncture. Alternately, a needle adaptor as heretofore described ca n be used.
  • one or, as desired, some of the collection containers 48, 58, and 59, the transfer containers 60a and b or 61a, as well as one or both of the saline and anticoagulant bags 70 and 76 constitute entities which are normally separate from the rest of the system 88.
  • each of the separated containers 48, 58, 59, 60, 61, 70, and 76 is preferably carried in a tear-away protective overwrap 90.
  • the overwrap 90 associated with the saline and anticoagulant bags 70 and 76 also preferably serves as a vapor barrier to prevent evaporation of anticoagulant or saline from the bags.
  • the system 88 further includes means 92 for establishing a fluid path between each of the containers 48, 58, 59, 60, 61, 70, and 76 and the associated part of the system 88 in a manner which does not compromise the sterile closed integrity of any of the containers or of the formed system as a whole.
  • the formed system may be configured as system 10 (in Fig. 1) or as system 11 (in Fig. 3).
  • the means 92 includes normally closed first and second connector means, respectively 94 and 96.
  • the first connector means 94 communicates with each of the normally separate containers.
  • the second connector means 96 communicates with each of the corresponding branch conduits through which fluid communication with the system 88 is made.
  • FIGs. 8 through 11 only the connector means 94 and 96 used to interconnect the first collection container 48 and the branch conduit 46 are shown in detail. However, the connector means 94 and 96 associated with the remaining portions of the system 88 are identical to those shown in Figs. 8 through 11.
  • each connector means 94 and 96 includes means 98 for selectively mechanically coupling the associated pairs of first and second connector means 94 and 96 together with a portion 100 of each in facing contact (see Figs. 10 and 11).
  • the facing portions 100 include means 102 operative for melting to form a fluid path through the joined pairs of the connector ⁇ means 94 and 96, thereby opening fluid communication between the associated container and the branch conduit, but only in response to exposure to an energy source efficient in itself to effectively sterilize the means 102 as they melt. This constitutes an active sterilization step which occurs simultaneously with the formation of the fluid path.
  • the means .102 are preferably operative for fusing together to form a hermetic seal about the periphery of the fluid path. The resulting connection is thus internally sterile and closed from communication with the atmosphere.
  • the connector means 94 and 96 may be variously constructed and employ different means of operation. However, to meet the desired increased-yield objectives of the system 88, the connector means 94 and 96 each must meet certain operative requirements.
  • each connector means 94 and 96 must (1) normally close the associated portion of the system 88 from communication with the atmosphere; (2) be opened only in conjunction with an active sterilization step which serves to sterilize the regions adjacent to the fluid path as the fluid path is formed; and (3) be capable of hermetically sealing the fluid path at the time it is formed. It has been determined that the sterile connector generally described in Granzow et al U.S. Patents 4,157,723 and 4,265,280 meets all of the above criteria and, for this reason, such a connector is shown in the illustrated embodiment.
  • each connector means 94 and 96 includes a housing 104 which defines ' a hollow interior 106 (see Figs. 9 through 11) which communicates with its associated part of the system 88 as heretofore described.
  • the heretofore described meltable means 102 associated with the facing portions 100 of the connector means 94 and 96 takes the form of meltable wall means, each of which normally seals or closes the associated interior 106 from communication with the atmosphere (see, in particular. Fig. 9).
  • the housing 104 further ⁇ includes a tubular conduit portion 108 which communicates with the interior 106 and which serves to interconnect the first connector means 94 with a length of a tubing 110 integrall connected with the associated container (which is the container 48 in Figs. 8 through 11), as well as the second connector means 96 with the associated branch conduit (which is the conduit 46 in Figs. 8 through 11).
  • connector means 94 and 96 may be variously attached to the end of the tubing 110 or with the branch conduits, in the illustrated embodiment, a hermetic, friction fit between the tubular conduit portion 108 is envisioned.
  • tubing 110 associated with each of the first connector means 94 is integrally connected with each of the associated containers (see Fig. 8).
  • an inline valve member 114 (shown in phantom lines in Fig. 8) is preferably provided. Use of the valve member 114 is particularly preferred in conjunction with the initially fluid-filled bags 70 and 76.
  • valve member 114 may be variously constructed, in the illustrated embodiment, it takes the form of an inline frangible valve member such aa one disclosed in Bayham et al, U.S. Patents No. 4,181,140 and 4,294,247.
  • the frangible valve member 114 can form an integral part of the connector housing, as is shown in Granzow et al, U.S. Patent 4,265,280.
  • the wall means 102 is fabricated from a radiant energy absorbing material. It is thus operative for melting in response to exposure to a source of radiant energy. Furthermore, the material from which the wall means 102 is constructed is purposefully preselected so that it melts only at temperatures which result in the rapid destruction of any bacterial contaminant on the surface of the material
  • the housing 104 is made of a material which does not absorb the particular type of radiant energy selected.
  • the wall means 102 is made of a material fabricated from poly(4-methyl-l-pentene), which is sold under the trademark TPX by Mitsui Chemical Company. This material has a crystalline melting point of approximately 235 ⁇ C and is further discussed in Boggs et al U.S. Patent 4,325,417.
  • the material of the wall means 102 includes a carbon filler so as to absorb infrared radiation.
  • the housing 104 is made of a clear TPX material which is generally transparent to the passage of radiation.
  • the connecting means 98 takes the form of mating bayonet-type coupling mechanisms, which serve to interlock the connector means 94 and 96 together with their radiant energy absorbing wall means 102 in facing contact (see, in particular. Fig. 10).
  • the radiant energy absorbing wall means 102 melt-and fuse together, as can be seen in Fig. 11.
  • the wall means 102 form a hermetically sealed opening 118 which establishes through the joined connector means 94 and 96 a fluid path which is at once sterile and hermetically closed to communication with the atmosphere.
  • Bacillus subtilis var niger (globiguii) spores per milliliter was prepared. This organism was chosen because of its high resistance to dry heat (see Angelotti, et al, "Influence of Spore Masture Content on the Dry Heat Resistance of Bacillus subtilis var niger'!, ' Appl. Microbiol., v 16 (5): 735-745, 1968).
  • test Connectors Forty (40) of the inoculated uncoupled connectors were each attached to empty, sterile containers. The other forty (40) were each attached to containers containing a sterile microbiological growth medium (soybean casien digest (SCD) broth). These inoculated pairs of connector members will hereafter be referred to as the Test Connectors.
  • SCD microbiological growth medium
  • OMPI 37"C The subcultures were examined for the presence of orange colonies, which is characteristic of the indicator organism.
  • the system 88 shown in Fig. 7 comprises a series of initially separate subassemblies which can be easily manufactured, packaged, sterilized, shipped, and stored.
  • the system 88 gives the operator the flexibility to conveniently tailor the configuration of the system 88 to meet the collection objectives of the particular procedure. For example, beginning with the system 88 shown in Fig. 7, the operator can selectively configure a system 10 as shown in Fig. 1 (to carry out the method shown in
  • the systems 10, 11, and 88 each of which embodies the features of the invention, permit the maximum yields and the maximum storage times permissible for the collected components. None of the systems 10, 11, and 88 is dependent upon

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  • Health & Medical Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Hematology (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Engineering & Computer Science (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Cardiology (AREA)
  • External Artificial Organs (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)

Abstract

Un système (10) réunissant les caractéristiques de cette invention comprend un premier mécanisme (12) servant à créer un écoulement de sang entier d'un donneur et un deuxième mécanisme (14) destiné à séparer le sang entier en composants essentiellement de plasma et en composants pauvres en plasma sans recourir à un dispositif de centrifugation. Ce système (10) comprend également un troisième mécanisme (16) conçu pour récupérer un certain volume du plasma séparé et un quatrième mécanisme (18) pour retourner au donneur les composants pauvres en plasma ainsi que le volume récupéré de plasma séparé. Ce système comprend en outre un cinquième mécanisme (20) qui sert à récupérer un certain volume de sang entier. Dans le mode préférentiel de réalisation, le deuxième mécanisme (14) possède un dispositif à membrane microporeuse (22) destiné à séparer le plasma des autres composants du sang entier. Dans ce même mode préférentiel de réalisation, le cinquième mécanisme (20) possède un dispositif (60) conçu pour récupérer les composants du sang entier en réponse à la séparation ultérieure par centrifugation.
EP19830902661 1982-08-24 1983-07-21 Systemes et procedes de recuperation de composants du sang a rendement accru. Withdrawn EP0118473A4 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US41105682A 1982-08-24 1982-08-24
US411056 2003-04-10

Publications (2)

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EP0118473A1 true EP0118473A1 (fr) 1984-09-19
EP0118473A4 EP0118473A4 (fr) 1985-09-16

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EP19830902661 Withdrawn EP0118473A4 (fr) 1982-08-24 1983-07-21 Systemes et procedes de recuperation de composants du sang a rendement accru.

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EP (1) EP0118473A4 (fr)
DK (1) DK139984A (fr)
ES (1) ES8405622A1 (fr)
IT (1) IT1163928B (fr)
WO (1) WO1984000892A1 (fr)
ZA (1) ZA835771B (fr)

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JPH06104118B2 (ja) * 1985-03-13 1994-12-21 バクスタ−、インターナショナル、インコ−ポレイテッド 血小板採取システム
SE453360B (sv) * 1985-11-18 1988-02-01 Gambro Lundia Ab Autotransfusionssystem for uppsamling, behandling och aterforing av en patients blod
AU578554B2 (en) * 1986-01-24 1988-10-27 Japanese Red Cross Society Centrifugal method of separating blood components
AU617265B2 (en) * 1988-06-23 1991-11-21 Asahi Medical Co. Ltd. Method for separating blood into blood components, and blood components separator unit
GB9111028D0 (en) * 1991-05-22 1991-07-17 Bio Flo Ltd Fluid treatment system
US5496265A (en) * 1992-03-04 1996-03-05 Cobe Laboratories, Inc. Blood component collection system with optimizer
JPH06261938A (ja) * 1992-07-07 1994-09-20 Senko Ika Kogyo Kk 透析装置及び返血方法
JPH11508813A (ja) 1995-06-06 1999-08-03 クウォンティック バイオメディカル パートナーズ 血漿を濃縮するための装置及び方法
US8409125B2 (en) 2006-11-08 2013-04-02 Haemonetics Corporation Adaptable perioperative cell-salvage system and methods and disposable units for same
WO2012093322A1 (fr) * 2011-01-03 2012-07-12 Desai Nainesh Sumanbhai Système de récupération de sang portatif
JP7004569B2 (ja) 2014-10-07 2022-01-21 ヘモネティクス・コーポレーション 流出血液の洗浄システムおよび方法
US11541161B2 (en) 2016-06-24 2023-01-03 Haemonetics Corporation System and method for continuous flow red blood cell washing
RU189169U1 (ru) * 2018-12-10 2019-05-15 Общество С Ограниченной Ответственностью "Направленный Транспорт" Аппарат для поточной сепарации жизнеспособных лейкоцитов из цельной крови

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DE3006455A1 (de) * 1980-02-05 1981-08-13 Takeda Chemical Industries, Ltd., Osaka Verfahren und vorrichtung zur niederdruck-filtration von plasma aus blut
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EP0082872A1 (fr) * 1981-06-25 1983-07-06 BAXTER INTERNATIONAL INC. (a Delaware corporation) Dispositif de commande de l'ecoulement d'un fluide

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Also Published As

Publication number Publication date
ES525118A0 (es) 1984-06-16
DK139984D0 (da) 1984-02-29
IT1163928B (it) 1987-04-08
ES8405622A1 (es) 1984-06-16
EP0118473A4 (fr) 1985-09-16
WO1984000892A1 (fr) 1984-03-15
IT8322618A0 (it) 1983-08-23
ZA835771B (en) 1984-05-30
DK139984A (da) 1984-03-15

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