EP0070159A2 - Appareil centrifuge et méthodes pour la séparation de fluides en leurs composants - Google Patents

Appareil centrifuge et méthodes pour la séparation de fluides en leurs composants Download PDF

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Publication number
EP0070159A2
EP0070159A2 EP82303594A EP82303594A EP0070159A2 EP 0070159 A2 EP0070159 A2 EP 0070159A2 EP 82303594 A EP82303594 A EP 82303594A EP 82303594 A EP82303594 A EP 82303594A EP 0070159 A2 EP0070159 A2 EP 0070159A2
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EP
European Patent Office
Prior art keywords
bag
blood
component
container
flow
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.)
Granted
Application number
EP82303594A
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German (de)
English (en)
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EP0070159A3 (en
EP0070159B1 (fr
Inventor
Allen Latham, Jr.
Donald W. Schoendorfer
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Haemonetics Corp
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Haemonetics Corp
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Priority claimed from US06/281,649 external-priority patent/US4402680A/en
Priority claimed from US06/281,655 external-priority patent/US4421503A/en
Application filed by Haemonetics Corp filed Critical Haemonetics Corp
Priority to AT82303594T priority Critical patent/ATE31033T1/de
Publication of EP0070159A2 publication Critical patent/EP0070159A2/fr
Publication of EP0070159A3 publication Critical patent/EP0070159A3/en
Application granted granted Critical
Publication of EP0070159B1 publication Critical patent/EP0070159B1/fr
Expired legal-status Critical Current

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    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B04—CENTRIFUGAL APPARATUS OR MACHINES FOR CARRYING-OUT PHYSICAL OR CHEMICAL PROCESSES
    • B04B—CENTRIFUGES
    • B04B5/00—Other centrifuges
    • B04B5/04—Radial chamber apparatus for separating predominantly liquid mixtures, e.g. butyrometers
    • B04B5/0407—Radial chamber apparatus for separating predominantly liquid mixtures, e.g. butyrometers for liquids contained in receptacles
    • B04B5/0428—Radial chamber apparatus for separating predominantly liquid mixtures, e.g. butyrometers for liquids contained in receptacles with flexible receptacles
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B04—CENTRIFUGAL APPARATUS OR MACHINES FOR CARRYING-OUT PHYSICAL OR CHEMICAL PROCESSES
    • B04B—CENTRIFUGES
    • B04B13/00—Control arrangements specially designed for centrifuges; Programme control of centrifuges

Definitions

  • the present invention relates to centrifuging apparatus and methods for separating fluids into components thereof.
  • Applicants' Application No. 80300198.1 describes a centrifuge (hereinafter the Latham centrifuge) for separating one or more components of blood into precise fractions.
  • Such centrifuges operate under the principle that fluid components having different densities or sedimentary rates may be separated in accordance with such densities or sedimentary rates by subjecting the fluid to a centrifugal field.
  • a flexible, disposable blood processing bag is mounted within the rotor of a self-balancing centrifuge rotor in a contoured/pro- cessing chamber consisting of a pair of support shoes.
  • the contoured chamber is designed to support the blood bag in a position whereby separated blood components traverse a short distance in the process of separation.
  • a flexible displacer bag is employed as a movable diaphragm to apply pressure to the disposable blood bag in response to the introduction of displacement fluid into the displacer bag while the centrifuge rotor is either rotating or stationary. Such pressure tends to expel separated blood components from the disposable blood bag.
  • the flexible blood processing and displacer bags are located radially outward from a centrally located collection chamber.
  • a pressure of 7977.04 N/mm 2 must be generated by the displacer fluid to expel blood compoents from the processing bag into the collection chamber.
  • this force can amount to 14768 N and the generation of such large forces tends to move or push the contoured shoes apart.
  • the requirement for a contoured shoe limits the volume of the blood processing bag to a size that will fit into the contours of the shoe.
  • the cost of fabricating the bags should be kept to a minimum.
  • the bags must not rupture under the tremendous forces they are subjected to during the centrifuge process. If these forces are minimized, the bags can be constructed of low-cost materials.
  • a need therefore exists for a blood processing centrifuge apparatus which is capable of handling different volumes of whole blood, does not require a supply of displacer fluid, minimizes the pressure to which the blood processing bags are subjected and provides for automatic termination of flow once a desired quantity of components has been expelled.
  • the present invention provides, from one aspect, apparatus for use in the centrifugal separation of blood into at least a first blood component and a second blood component comprising: a flexible blood processing bag for containing anti-coagulated whole blood and having an outlet port; a receiver container for receiving a component of said whole blood and having an input port; and tubing means providing fluid communication between the output port of the bag and the input port of the receiver container; characterised by valve means for terminating flow of fluid component out the output port of the bag in response to the specific gravity of said component.
  • the present invention further provides apparatus for processing fluids in a centrifugal force field to separate constituent components of such fluids comprising in combination: a centrifuge having a rotor adapted to rotate at a sufficient speed to cause said components to separate; a flexible bag for containing a first fluid; and a receiver container for receiving at least one component of said first fluid; characterised by mass means disposed nearer the center of rotation of the rotor than the flexible bag and adapted to move and contact a surface of said bag, said mass being sufficient to at least initiate a flow from said bag to said container of component fluid separated in said bag.
  • the present invention still further provides a method in which blood is centrifugally separated into a first blood component and second blood component in a-blood processing chamber and first blood component is thereafter caused to flow through an outlet port of said chamber through a conduit and into a receiver container; characterised by causing said flow by a weight disposed adjacent said chamber.
  • the present invention is particularly useful for various pheresis processes such as plasma pheresis or platelet-pheresis.
  • the apparatus of the present invention may comprise a centrifuge of the type described in our concurrently filed Application No.
  • the flexible bag containing the whole blood is located on the rotor a suitable distance away from the center of rotation of the rotor.
  • the receiver container is disposed adjacent the bag and in fluid communication with the bag.
  • the receiver container is adapted to receive one or more of the centrifugally separated components of the whole blood.
  • the receiver container is shown as a flexible bag, however, it need not be. flexible.
  • a pressure plate in the form of a body of material, such as a metal plate, having a predetermined mass is slideably disposed in the radial direction between the flexible bag and the center of rotation of the rotor.
  • This pressure plate is suspended so that it is free to move radially against the flexible bag when subjected to the centrifugal forces generated by rotation of the centrifuge.
  • the pressure plate has a predetermined mass sufficient to-at least initiate a flow of separated fluid component from the flexible bag to the second bag as the pressure plate presses against the first bag during rotation of the centrifuge.
  • the pressure plate has a predetermined mass distribution and shape adapted to pool the separated first blood component in the area of the output of the fluid communication to the second bag.
  • the pressure plate is adapted to press against the first bag and cause the radius at the output of the first bag to be located at the minimum radius of the first bag in the centrifuge.
  • a suitable timing mechanism such as that described in Applicants' concurrently filed Application No. , is provided for controlling the flow of components from the first to the second bag until sufficient separation has been achieved.
  • the first bag and second bag are located adjacent each other on the rotor with the first bag positioned radially inward from the second bag.
  • a siphon effect is created when flow is initiated from the first bag to the second bag due to the difference in centrifugal forces to which the bags are subjected because one bag is located nearer the center of rotation than the other.
  • flow from the first bag to the second bag, once initiated will continue regardless of the specific gravity of the separated blood component.
  • a valve is provided.
  • Pheresis Valve may be in the form of a stopper having a specific gravity less than the component or components to be retained in the first bag, but greater than the component or components to be expressed into the second bag.
  • the stopper may be a free-floating ball, a ball contained within guide channels or a flap attached at one end to an interior surface of the blood processing bag adjacent to its outlet port, or other similar stoppers.
  • the stopper is provided in a disposable software set designed for use in a Self-Balancing Centrifuge.
  • the software consists of a flexible blood-processing bag having an inlet port and an outlet port and being suitable for mounting in the processing chamber of a Self-Balancing Centrifuge.
  • Blood compatible tubing extends between the inlet port of the blood-processing bag and a connector to a source of blood to be separated.
  • a source of blood might be a human donor, in which case the connection means might be a phlebotomy needle, or the source may be a bag containing whole blood, in which case the connection means might be a bag spike.
  • the disposable software also includes a receiver container for first blood component which is expelled from the processing bag.
  • the receiver container is connected to the outlet port of the flexible blood-processing bag so that expelled first blood component can be directed into the receiver container.
  • the flexible blood-processing bag also contains valve means for sealing its outlet port in response to the difference between the specific gravities of separated first and second blood components.
  • An example of a suitable means for sealing is a valve with a stopper which has a specific gravity which is higher than the specific gravity of first blood component but lower than the specific gravity of second blood component.
  • the stopper may be a free-floating ball, a ball contained within guide channels, a flap attached at one end to an interior surface of the blood-processing bag adjacent to its outlet port, or other similar stoppers.
  • the valve operates in a fully automatic way depending only on the difference in specific gravities between the separated components.
  • the valve is versatile in the sense that it can be adapted to provide a precise cut between any number of different blood components based upon their specific gravity difference.
  • the precise cut can also be adjusted by changing the.size of the stopper, e.g., providing a large or small diameter ball, or by changing its shape.
  • the use of such a stopper eliminates the extreme precision required in the geometry and weight of a pressure plate if a precise cut in blood components is to be made.
  • the stopper can be made an intergral part of the software supplied for use in any particular blood separation.
  • valve may be made intentionally leaky so that the stopper is unseated and additional separation may be made by re-cycling the valve.
  • first and second bags are disposed adjacent each other substantially equidistant from the center of rotation of the rotor.
  • the mass of the pressure plate positioned against the first bag is such that it is.of sufficient value to create just enough force against the first bag to express only the less dense component(s) from the first bag to the second bag.
  • the second bag is located closer to the center of rotation than the first bag and the mass of the weight plate is such that it produces sufficient pressure to express specific lighter components of blood in the second bag but lacks sufficient pressure to express specific heavier components from the first bag.
  • a low-cost aseptic, disposable apparatus in combination with a centrifuge system wherein blood components may be automatically separated from whole blood without the need for displacer fluid or contoured shoes.
  • An apparatus of the invention is able to accomodate various volumes of whole blood for processing and may be operated by unskilled personnel since human intervention is minimized.
  • the present invention includes an apparatus and method for separating blood into components thereof in a centrifuge.
  • the invention is particularly suitable for various pheresis processes, such as, (a) plasma-pheresis, where in whole blood is removed from a donor, separated into cell-free plasma and packed red blood cells followed by re- infusion of the autologous red cells or (b) platelet-pheresis, wherein whole blood is removed from a donor and separated into three components, platelet-rich plasma (PRP), platelet-poor plasma (PPP) and packed red blood cells (RBC) followed by reuniting the PPP and RBC which are returned to the donor, or similar component separation where the donor donates a unit of blood which is separated into plasma and packed red cells; plasma, platelets and packed red cells; or plasma, platelets, white cells and packed red cells.
  • PRP platelet-rich plasma
  • PPP platelet-poor plasma
  • RBC packed red blood cells
  • the invention will generally be described in connection with component separation of whole blood into plasma, platelets, and packed red cells by centrifugal separation in accordance with the specific gravity of the components but the invention is not intended to be limited thereby.
  • separation in accordance with the sedimentation rate of individual components is also contemplated by this invention.
  • FIG. 1 For simplicity, only a top view of the Self-balancing Centrifuge 2 is shown in Fig. 1.
  • the apparatus shown in Fig. 1 is adapted to conduct two pheresis processes simultaneously and therefore has duplicate process apparatus within each half of the rotor of centrifuge 2.
  • Rigid cassettes 17 are mounted on opposite sides of the rotor of centrifuge 2 within cylindrical housing 34.
  • Each cassette 17 consists of a stand, or rack, which is partitioned into three annular sections by two vertically positioned support members 22 and 24 each having a shape generally described by a segment of a hollow cylinder with a radius corresponding to the radius to the center of rotation of the centrifuge rotor (as shown in detail in Fig. 4).
  • a sufficient volume of anticoagulant may be initially stored in the whole blood bag 8 or the appropriate anticoagulant ratio may be pumped with the blood.
  • tube 50 is heat sealed close to bag 8 and the section of tube 50 containing the phlebotomy needle is disconnected and discarded.
  • a pressure plate 10 is suspended adjacent the whole blood bag 8 on two mounting bolts 91 and 93 (shown in Fig. 4)
  • Bag 8 is loaded in the cassette while pressure plate 10 is moved radially inward. This allows sealed bag 8 filled with anticoagulated whole blood to be inserted into the space between the plate 10 and the cassette wall 22.
  • the PRP bag 6 is inserted into the next section of the cassette and the PPP bag 4 in the last section, which is the section furthest removed from the center of rotation.
  • An additional pressure plate 11 may be provided adjacent the side of the PRP bag 6 nearest the center of rotation. As will be described in detail later, this pressure plate cooperates with a flexible elastomeric gasket to isolate platelets and prevent them from flowing out the PPP tube 54.
  • the PRP tubing 52 and PPP tubing 54 are initially clamped "off" by operation of the hydraulic timer mechanism 15.
  • the centrifuge 2 is then brought to a suitable speed, for example, 2000 r.p.m., . for a sufficient time to allow centrifugal separation of PRP and packed RBC's within bag 8, i.e. about one minute.
  • the hydraulic timer 15 then unclamps the PRP tubing 52 by rotating clamp 31.
  • the pressure exerted by the weight plate 10 on the whole blood bag 8 as the rotor continues to spin is sufficient to force the plasma separated in bag 8, which is of lower density, out the exit port of the bag and into PRP tubing 52, which is centrally located on the side of the whole blood bag nearest the center of rotation.
  • the weight plate is needed here as initially the PRP must be pushed toward the center of rotation of the rotor as it leaves the blood bag.
  • the difference in potential energy from the whole blood bag 8 to the PRP bag 6 favors flow in that direction and pressure from the pressure plate 10 is no longer required to maintain flow.
  • the plate still serves a useful function to prevent the buildup of excessive dynamic waves on the inner wall of the blood bag.
  • This siphon effect is advantageous in that the mass of the pressure plate 10 and the pressure that it generates in the centrifugal force field is minimized. Therefore, the pressure holding capacity of the blood bags is greatly reduced and lower cost disposable plastics bags may be utilized. On the other hand, once initiated, fluid flow will continue, therefore, means are required to automatically stop the flow of plasma before any RBC is lost.
  • this automatic flow control means (shown generally at 117) is provided by a Pheresis Valve with a ball stopper 112 having a specific gravity greater than PRP (about 1.03) but less than that of RBC
  • This ball stopper is located in the whole blood bag 8 so as to float on top of the
  • RBC layer 116 A separated first blood component, such as plasma layer 114, occupies the radially inner portion of the flexible blood-processing bag 8 whereas separated second blood component such as RBC layer 116, occupies the radially outward portion.
  • the pressure plate 10 applies a force in the radially outward direction (arrows A) which tends to collapse the flexible blood processing bag 8 and expel first blood component (plasma layer) 114 therefrom.
  • the stopper ball 112 is contained within a guide member 119 formed by a cylindrical wall member 118, an end wall member 120, and a stopper ball seat 122.
  • the cylindrical wall member 118 has one or more input ports 124 located relatively close to the stopper ball seat 122.
  • Separated first blood component (PRP) enters the input port(s) (as shown by arrows B) in the cylindrical wall member 118 and leavesthe flexible blood bag 8 and flows through output port 128 into tubing 52 in the direction of arrow C to PRP bag 6.
  • the inner diameter of the cylindrical wall member 118 is chosen such that the stopper ball is free to move axially within guide 119 in the direction C, but not radially of the wall member 118.
  • the end wall member contains one or more end wall ports 124. When the radial depth of the first blood component 114 is greater than the radial depth of the end wall member 120 within the flexible blood processing bag 8, the stopper ball 112 rides on is supported by, the end wall member.
  • the interface between said first and second components approaches the output port 128, of the flexible whole blood-bag 8.
  • the stopper ball 112 also approaches the output port 128.
  • the stopper ball 112 is carried into contact with the seat of guide 119 and forms a seal with the port. This is illustrated in Fig. 7 wherein substantially all of the first blood component 114 has been expelled from the flexible, whole blood bag 8 and all that remains is second blood component 116.
  • flow is thus immediately halted automatically.
  • the specific gravity of the stopper ball 112 is chosen so that it floats on the interface between the first and second blood components 114 and 116. That is, the stopper ball 112 has a specific gravity greater than the specific gravity of the second blood component 116.
  • the specific gravity of the stopper ball 112 is preferably chosen to be about midway between these values.
  • Typical materials for the.ball stopper is Dow Corning silicone which comes in specific gravities within this range and can be supplied with FDA Class VI certification, or conventional polystyrene.
  • the embodiments thus far described have operated on the principle that the blood component with the greater density, for example RBC, is retained in the container and the less dense component PRP is allowed to flow to another container, in some applications it may be desirable to reverse the process. For example, if the-outlet port and valve seat is located adjacent the more dense component, and a ball float with an intermediate density is disposed to float on the interface, as the more dense component is expressed out the port the interface and ball would move toward the valve seat and close in the manner previously described.
  • the blood component with the greater density for example RBC
  • a simple and inexpensive solution is illustrated.
  • the output port for tubing 52 on whole blood bag 8 is oriented by pressure-plate 10 to be at a minimum radius with respect to the radius of the bag 8 from the center of rotation.
  • any air in the bag 8 will collect in the area of the output port.
  • tubing 52 is unclamped by clamp 31 of mechanism 15, this air must flow out of the bag 8 and into the PRP bag 6 before any plasma will flow.
  • the section of tubing labelled 52B has an unusually small internal diameter, ID 2 as compared to a normal inner diameter ID 1 on the remaininq section 52A of tubing 52.
  • Section 52B is the section of tubing which extends radially outward from the clamp -15 and therefore fluid in this section is in effect forced to flow downhill with the centrifugal force. With the internal diameter reduced in this section, the velocity of flow increases and air bubbles which would otherwise be trapped in this section are forced to flow "down" the tube 52 to PRP bag 6.
  • a similar reduced diameter tubing is not required in tube 54 as there is no need for an umbilical fitment on PRP bag 6 as there was in the whole blood bag 8. Because of this, air in bag 6 is not localized in the area of the output port and therefore is not expressed from bag 6 with the PPP.
  • a barrier 802 is provided intermediate the PPP output port and the PRP input port.
  • This barrier may be conveniently made by conventional heat or R.F. sealing during the fabrication of the bag 6.
  • the barrier should preferably extend along the length of the bag from the input ports to about one inch from the bottom as shown by the vertically extending solid and dotted lines in Fig. 8.
  • Fig. 8 also shows a preferred embodiment of the apparatus for fixing the final volume of the platelet concentrate (PRP) left in PRP bag 6.
  • Pressure plate 11 is free to move radially against PRP bag 6 under the influence of centrifugal force.
  • the plate 11 is of sufficient size to eclipse one side of bag 6.
  • the other side of PRP Bag 6 abuts fixed support member 24.
  • a flexible elastomeric gasket 806 is affixed to support member 24 of cassette 17 in a radial plane.
  • the PRP/PPP separation apparatus functions as follows:
  • PPP tubing 54 is unclamped. As separated PPP flows from the PRP bag 6, the bag tends to collapse and pressure plate 11 approaches the elastomeric gasket 806 and eventually compresses the PRP bag against the gasket forming a transverse barrier along the length of gasket 806 thereby preventing further flow out the PPP tube thus isolating the remaining plasma, which, for the reasons previously given, will be rich in platelets.
  • the location of the elastomeric gasket in relation to the height of the PRP bag 6 and the thickness of the gasket is adapted to isolate a predetermined volume of plasma in the PRP bag 6.
  • a predetermined volume of plasma in the PRP bag 6 For example, in the embodi- . ment of Fig. 8, 50 milliliters can be retained with a 1/16" ID by 1/8" OD tube gasket located one-third down the height of a 6" x 10" bag.
  • pressure plate 11 also functions to prevent formation of dynamic waves on the inner surface of the PRP bag 6.
  • mass of the pressure plate may be varied by adding or subtracting mass and thereby controlling the flow of PRP from the whole blood bag. A more massive pressure plate on the PRP bag in relation to the mass of the pressure plate on the whole blood bag 8 will decrease the rate of PRP flow since it will increase the back pressure on PRP bag 6.
  • Pressure plate 11 may also be fashioned with a section 803 cut out on the side opposite the PPP and PRP tubes 52 and 54.
  • This cut out section 803 allows the PRP bag to bulge out within the cut out section. Since this bulge is pushed radially inward, any air 809 in PRP bag 6 will be pushed into the bulge and be isolated from the PPP output tube 54. This acts as a safety factor to prevent the vapor lock effect from occurring in tube 54.
  • clamps 31 and '35 of timer mechanism 15 clamp PRP tube 52 and PPP tube 54 and the centrifuge rotor is brought to rest.
  • the end result of this process is a bag of packed RBC, a bag of PRP in bag 6 and a bag of PPP in bag 4.
  • Figs. 9 and 10 the effect of the size of the stopper ball 112 on the precise blood cut achieved is illustrated.
  • the ball stopper 112 has a relatively large diameter and tends to contact and seal outlet port 128 prior to the expulsion of all the first blood component l14. If the first blood component 114 is plasma and the second blood component 116 is packed red cells, the effect of the larger diameter ball stopper 112 is to lower the hematocrit of the second blood component remaining in the blood processing bag 8. On the other hand, when a relatively smaller diameter ball stopper is employed, such as in Fig. 10, a much smaller amount of PRP 114 remains in the flexible blood processing bag 8. Thus, the hematocrit of the second blood component or packed red cells 116 is raised.
  • Fig. 11 shows a further embodiment of a Pheresis Valve for sealing the outlet port of a flexible blood processing bags.
  • a hinged flap 110 has one end joined to an interior surface of the flexible blood-processing bag 8 at a position adjacent to the outlet port 128.
  • the hinged flap 110 is of a density similar to that of the stopper ball 112 and operates in a manner . similar to the stopper ball 112 previously described in that it floats at the interface between first blood component 114 and second blood component 116.
  • the hinged flap is carried' into contact with the outlet port 128 thereby creating the required seal.
  • One way to make the valve re-open is to minimize the negative pressure force in the direction C of Fig. 6 and maximize the positive buoyancy force in the opposite direction created by the volume of fluid left in the bag 8. This could be accomplished by decreasing the cross-sectional area of the output tube 52 and increasing the size and therefore the buoyant volume of the valve float. The latter is undesirable since it increases the manufacturing cost of the bag and the former increases the disruptive shear stresses of blood components flowing through the valve, thereby increasing the probability of occlusions.
  • Fig. 12 is a cross-sectional view taken along the lines 12-12 of Fig. 7.
  • the valve seat 122 is made leaky by one or more tiny slots 212 on the valve seat 122 so that the negative downstream pressure is dissipated.
  • the slots leak about 1 millilitre per minute when the ball valve is seated.
  • FIG. 13 and 14 A further embodiment of the invention in which the PRP bag pressure plate 1-1 is eliminated is shown in Figs. 13 and 14.
  • the PRP input port for tubing 52 and output port for PPP tubing 54 are located at the top of PRP bag 6.
  • the timer clamp 15 is located as close to rotor housing 34 as possible.
  • the inner diameter of the PPP tubing 54 is large enough so that the capillary air bubble surface tension inside the tube is less than the centrifugal force'pressure on the fluid in the tube.
  • the PPP tube 54 and bag 4 are empty.
  • the air in the PPP tubing 54 is locked by the plasma.
  • the air surface in the tube 54 cannot withstand the outward pressure of the plasma and this air is displaced out of the PPP tubing 54 into bag 6.
  • a mass clamp 302 such as a 1.27 mm thick strip of plastics, may be disposed adjacent the inner wall of bag 6 opposite the ramp and near the outlet to PPP tubing 54. This mass clamp 302 will terminate PPP flow at a predetermined volume. Such volume may, for example, be at a ratio of 50 ml of plasma for each single unit platelet concentrate left in PRP bag 6 as presently specified by clinical standards.
  • first blood processing bag nearer to the center of rotation than the second bag (which as aforesaid may merely be a rigid receptacle for receiving separated components) as in the embodiments heretofore illustrated, it may be desirable to have a "side-hv-side" arrangement in which the first and second bags are located along the periphery or the rotor housing equidistant to the center of rotation as giagrammatically illustrated in Fig. 15
  • a centrifuge 140 of the type previously described rotates about a center of rotation labelled "CR".
  • the centrifuge rotor housing 142 supports two flexible bags 144 and 146 in a vertical position on the periphery of the rotor and equidistant from the center of rotation.
  • a contoured framework 150 with concave inwardly extending surfaces allows bag 144 to rest naturally against the housing inner surface with a minimum of stress on the bag wall material when subjected to centrifugation. Alignment pins (not shown) keep the bag 144 properly oriented.
  • Inner wall 152 of bag 144 is essen- .tially free-standing except for a light weight, stiff, curved pressure plate 148 disposed against the surface of inner wall 152 so as to produce a liquid pressure in the bag when subjected to the centrifugal field.
  • Interconnecting tubing 154 is provided between the exit port of first bag 144 and the second bag 146 (in this case the receiver container). This tubing passes over a curvilinear contour (or dam) 156 which may be incorporated into the framework 150.
  • This contour is sufficiently large to assure that the exit port of bag 144 is at a lesser distance from the center of rotation than any other portion of the bag 144.
  • the shape of the container is such that the fluid pathway in the first bag near the exit port is in the form of an approach ramp with gradually decreasing radius for locations progressively closer to the exit port.
  • the second bag 146 is merely a receiving container for the separated component from the first bag.
  • the volume of this container is pre-established to just accomodate the volume of separated component (supernatant) desired to be recovered from bag 144.
  • Suitable support means (not shown) hold bag 146 in place against rotor housing 142. Flow from bag 144 to bag 146 is terminated by setting the volume of the second bag 146 so that it is filled completely before all the supernatant has passed from the first bag 144.
  • the pressure in the first bag is proportional to the difference between the squares of the radii to the input and output of the fluid column, to the density of the fluid in the column, and to the square of the rotatinq speed.
  • the density of packed RBC is about 1.10, whereas the density of the supernatant plasma is about 1.03. Greater pressure is therefore required to force red cells radially inward to a given radial point than is required to force plasma at this point. Therefore, when the cut is being made, flow from bag 144 to bag 146 will automatically cease when RBC pass part of the way through the radial passage 154 to the second bag 146, provided the weight of prcs- sure plate 148 is suitably matched to the process.
  • the operating protocol must include a first period of centrifugation while the interconnecting tubing is clamped shut as by the previously described timer mechanism 15 or equivalent. Then the clamp may be opened and clear supernatant may be passed over into the bag in the second compartment 146 until packed RBC flow part way through the interconnecting pathway.
  • Fig. 16 is an improved version of the Fig. 15 apparatus wherein the pressure plate 148 is made large enough in surface area to cover the entire area of wall surface 152 of first blood processing bag 144, thus no bulging is possible. Additionally, the center of gravity of pressure plate 148 is off-centered slightly to a point labelled 164; thereby automatically providing a more optimal separation zone. The center of gravity may be off-set by contouring the shape of plate 148 or by adding or subtracting material from the plate as required. The dam or ramp 156 previously located on the rotor housing is now located on the pressure plate 152 and moves with the plate thereby providing a more constant ramp function.
  • Figs. 15-16 the separation process may be extended in a variety of ways as shown for example in Fig. 17 by adding a pressure plate 180 on bag 146 and interconnecting bag 146 over a second dam 184 to a third bag 182.
  • a process similar to the three bag pheresis process described in connection with Figs. 1-8 may then be carried out by clamping the interconnecting tubing with clamps 185 and 187 at appropriate intervals and centrifugally separating RBC and plasma from whole blood in bag 144.
  • the plasma is then expressed to bag 146 by means of a pressure plate 148 having a mass just sufficient to express the lighter weight plasma sideways over the dam 156 and into bag 146.
  • the plasma in bag 146 is centrifugally separated into PRP and PPP.
  • the PPP is expressed sideways over the second dam 184 by the force of pressure plate 180 which is preestablished so as to express all but a fixed volume of fluid, for example 50 ml, into the fhird bag 182.
  • the clamps 185 and 187 may be controlled by a hydraulic timer mechanism as described earlier.
  • FIG. 18 Another application of the invention' is shown in the embodiment of Fig. 18 which illustrates red blood cell washing apparatus.
  • Fig. 18 three flexible bags 190, 192, and 194 are disposed about the periphery of the rotor housing 142 of centrifuge 140 equidistant from the center of rotation CR.
  • Bag 190 contains a washing solution, such as a solution of sterile saline.
  • Bag 194 is interconnected with bag 190 by tubing 196 and with spent solution bag 192 by tubing 198 which extends over dam 195.
  • Clamp means 191 and 193 operated by a timer mechanism (not shown) control the flow of fluid through respective tubing 196 and 198. :
  • Bag 194 is substantially similar to the blood processing bags previously described. It contains the whole blood or thawed glyceralized blood to be washed.
  • the final product of this procedure is a unit of packed washed red cells.
  • the hematocrit of the packed cells can be made very high.
  • the clamps for this procedure may-be controlled by the hydraulic timer clamp mechanism previously mentioned.
  • Fig. 19 The apparatus described in Fig. 19 is illustrated in connection with the present apparatus, however, the invention described in this embodiment may be applied to a variety of blood processing apparatus and methods.
  • the interconnecting tubing 52 between whole blood bag 8 and PRP bag 6 is shown disposed between a light transmitter element 250 and photo-detector 252 of a well-known beam optical sensor 260.
  • Beam sensor 260 may alternatively comprise a simple reflective optical beam sensor.
  • Tubing 52 also passes between a solenoid activated flow clamp 254.
  • the component line 52 will be clamped. This will trap the RBC's in the whole blood bag 8 and the plasma in the PRP bag 6. Similar apparatus can be used to sense the color change between PPP and PRP to actuate an additional clamp on the tubing 54 between the PRP bag and PPP bag.

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  • External Artificial Organs (AREA)
  • Centrifugal Separators (AREA)
EP19820303594 1981-07-09 1982-07-08 Appareil centrifuge et méthodes pour la séparation de fluides en leurs composants Expired EP0070159B1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AT82303594T ATE31033T1 (de) 1981-07-09 1982-07-08 Zentrifugenapparat und verfahren zur teilung von fluessigkeiten in ihre komponenten.

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US281649 1981-07-09
US06/281,649 US4402680A (en) 1981-07-09 1981-07-09 Apparatus and method for separating fluid into components thereof
US06/281,655 US4421503A (en) 1981-07-09 1981-07-09 Fluid processing centrifuge and apparatus thereof
US281655 1988-12-09

Publications (3)

Publication Number Publication Date
EP0070159A2 true EP0070159A2 (fr) 1983-01-19
EP0070159A3 EP0070159A3 (en) 1984-07-04
EP0070159B1 EP0070159B1 (fr) 1987-11-25

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Application Number Title Priority Date Filing Date
EP19820303594 Expired EP0070159B1 (fr) 1981-07-09 1982-07-08 Appareil centrifuge et méthodes pour la séparation de fluides en leurs composants

Country Status (5)

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EP (1) EP0070159B1 (fr)
AU (1) AU8565682A (fr)
DE (1) DE3277722D1 (fr)
DK (1) DK306582A (fr)
ES (1) ES8401322A1 (fr)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0935998A1 (fr) * 1998-02-17 1999-08-18 Andreas Hettich GmbH & Co. KG Centrifugeuse et poche à sang avec chambre de pression et chambre de sang

Families Citing this family (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4900298A (en) * 1987-08-21 1990-02-13 Cobe Laboratories, Inc. Centrifuge drive and support assembly
AU587949B2 (en) * 1987-08-26 1989-08-31 Cobe Laboratories Inc. Sterile blood component collection
EP2883616A1 (fr) * 2013-12-11 2015-06-17 Alfa Laval Corporate AB Soupape pour évacuer le gaz à partir d'un séparateur centrifuge
CN109569900B (zh) * 2019-01-25 2023-12-22 中国工程物理研究院总体工程研究所 一种土工离心机自平衡装置

Citations (5)

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Publication number Priority date Publication date Assignee Title
US3648697A (en) * 1969-08-01 1972-03-14 Gardner Newell J Intravenous feeding container and method of preparing the same
FR2152741A1 (fr) * 1971-09-07 1973-04-27 Corning Glass Works
US4010894A (en) * 1975-11-21 1977-03-08 International Business Machines Corporation Centrifuge fluid container
EP0014093A1 (fr) * 1979-01-22 1980-08-06 Haemonetics Corporation Appareil, procédé et voie sanguine du type jetable, utilisés pour la séparation du sang en ses composants
EP0026417A2 (fr) * 1979-09-22 1981-04-08 Firma Andreas Hettich Centrifugeuse pour un ensemble de sachets de sang en vue de séparer des constituants du sang

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3648697A (en) * 1969-08-01 1972-03-14 Gardner Newell J Intravenous feeding container and method of preparing the same
FR2152741A1 (fr) * 1971-09-07 1973-04-27 Corning Glass Works
US4010894A (en) * 1975-11-21 1977-03-08 International Business Machines Corporation Centrifuge fluid container
EP0014093A1 (fr) * 1979-01-22 1980-08-06 Haemonetics Corporation Appareil, procédé et voie sanguine du type jetable, utilisés pour la séparation du sang en ses composants
EP0026417A2 (fr) * 1979-09-22 1981-04-08 Firma Andreas Hettich Centrifugeuse pour un ensemble de sachets de sang en vue de séparer des constituants du sang

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0935998A1 (fr) * 1998-02-17 1999-08-18 Andreas Hettich GmbH & Co. KG Centrifugeuse et poche à sang avec chambre de pression et chambre de sang

Also Published As

Publication number Publication date
ES513812A0 (es) 1983-12-01
EP0070159A3 (en) 1984-07-04
ES8401322A1 (es) 1983-12-01
AU8565682A (en) 1983-01-13
DE3277722D1 (en) 1988-01-07
DK306582A (da) 1983-02-08
EP0070159B1 (fr) 1987-11-25

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