JP2004033721A - Device, system, and method for separating fluid using fluid pressure driving/balancing structure - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide a centrifugal fluid separating system used for centrifugally separating a composite fluid into components. <P>SOLUTION: The centrifugal fluid separating system includes at least one centrifugal rotor having a composite housing area, a plurality of fluid flow passages, and two or more separated recovering areas 43 and 44 demarcated in the flow passages. The composite fluid to be separated is sent to a fluid housing area 42, reaches a substantially annular peripheral fluid separating flow passage 50 from the area 42 through a flowing-in passage, and is separated into components by a centrifugal force. The separated components respectively enter into the separated component recovering areas 43 and 44 respectively through first and second separated fluid flowing-out passages 53 and 54. The passages 53 and 54 respectively have first and second heights and the heights are set to have such a correlation that substantially balances the fluid pressures of the separated components flowing through the passages 53 and 54. This pressure balance controls the boundary face between the fluid components separated from each other in the peripheral fluid separating flow passage 50. <P>COPYRIGHT: (C)2004,JPO

Description

[0001]
TECHNICAL FIELD OF THE INVENTION
This application claims priority from US Patent Application No. 60 / 245,282, filed November 2, 2000.
The present invention is generally directed to a centrifugal fluid separator, and more particularly to a pressure driven / balanced separator having a simple disposable tube and bag set for use with a rotor that preferably does not have a loop and does not seal by rotation. .
[0002]
[Prior art]
Many fluid separation devices are known, and various schemes are currently available for separating blood and other complex fluids into various components. For example, various centrifuges can be used to separate blood into constituent components such as red blood cells, platelets, plasma, and the like.
[0003]
The centrifugation used for such purposes is diversified in both the continuous type and the batch type. For example, in a widely used method known as continuous centrifugation, which is generally the opposite of batch processing centrifugation, a continuously injected composite fluid flows into a separation device or chamber while at the same time the components of the composite fluid are substantially continuous. And the separated components are usually subsequently removed from the apparatus or chamber almost continuously. Many types of such continuous fluid separation devices currently in wide use include multiple loops of inflow and outflow tubing lines connected to a separation centrifuge chamber, each loop preventing the tubing lines from rotating themselves. In addition, it rotates with respect to the centrifugal chamber in a relation of 1 omega-2 omega (1ω-2ω).
Alternatively, the tube line connection to the continuous centrifuge may have one or more rotary seals in connecting the tube line to the centrifuge chamber, so that the tube line does not rotate itself, instead of having such a loop. It can be used when needed.
[0004]
On the other hand, batch centrifugation is typically used to separate complex fluids such as whole blood in a closed chamber, or sometimes a deformable bag, and is usually used automatically and / or manually for one or more A complicated process of extruding the separated components from a separation container or a bag is required. Such prior art batch processing methods require a great deal of control, either automatically, such as by optical interface detection, or by human effort to monitor moving interfaces. In fact, prior art centrifugal separators, whether continuous or batch, are designed to drive the fluid flow to control the interface between the component elements separated by said device to a desired position. Various means and methods have been used. For example, as described above, various optical feedback methods and devices have been used in the prior art. Various pump and valve configurations are also used throughout. Alternatively, relatively automated flow-density interface control is also used, such as in a continuous system, by placing a control outlet at a strategic location relative to the outlet of the separated components. .
[0005]
Nevertheless, while these prior art separation devices have acceptable productivity, they also exhibit inefficiencies in achieving the desired optimum productivity. For example, centrifuges that use a loop of tube lines that rotate in the 1ω-2ω relationship described above with respect to the centrifuge chamber require a large, usually substantial, large drive mechanism, thereby providing such an overall device. Each one is necessarily relatively large. On the other hand, rotary sealing devices require a rotary sealing structure that is complicated and sometimes poses operational problems. Further, fluid drive and / or interface control systems according to the prior art are generally overly complex, as are most of the optical control types, and / or automatic flow / density control is typically inherent. However, due to the re-mixing of a part of the centrifuged components, they do not function completely efficiently during the separation.
[0006]
Therefore, there is still a need to provide a more efficient centrifuge in terms of efficient fluid drive and separation interface control. In particular, it is desirable to reduce the rotor drive mechanism, volume and / or scale, and / or reduce the need and / or complexity of the seal. Other objects of the present invention will be clarified later in this specification.
[0007]
[Problems to be solved by the invention]
The present invention is generally directed to a centrifugal fluid separation device and / or system for separating a composite fluid into component components contained therein by centrifugal force. Such centrifugation systems include a unique centrifugal rotor and a combination of rotor and fluid container, wherein each rotor preferably has a plurality of containers therein and rotates relative to a rotary drive. It is possible to arrange them together in free positions. The term “free rotation” indicates that the rotor does not have a loop and is not sealed by rotation, and that it is preferable that the rotor can be driven magnetically or non-invasively. Thus, a fully enclosed system may also preferably include a simple disinfection and fluid container / tube combination and / or rotor.
[0008]
[Means for Solving the Problems]
Each rotor has a centrally located area for receiving / containing the composite fluid, at least one component recovery area, and at least one fluid passage defined therein. In a preferred embodiment, the composite fluid to be separated component by component flows into a fluid receiving / receiving area, preferably a composite fluid container or bag. Thereafter, under centrifugal conditions, the composite fluid flows from the composite fluid container through a radial fluid inlet to an annular fluid separation passage where it is separated into components by centrifugal force. These components then flow through each annular passage section to a respective collection area, and can preferably be collected in a collection container or bag. These separated fluids can then be removed from the separation device or collection bag for storage or further processing, or returned to the donor. The composite fluid is preferably whole blood, each component being plasma and red blood cells (RBC), but other recoverable components may include, in particular, buffy coat and / or platelets.
[0009]
Each annular passage portion preferably includes or is connected to first and second fluid outflow passage portions for separated components to flow into each collection area. The first and second outlets preferably have first and second outlets, respectively, which outlets are preferably arranged at relatively radial positions, and the mutual location of the two outlets is The hydraulic or hydrostatic pressure is selected to be substantially balanced between the outlets through which the separated components flow. Such fluid pressure balancing preferably controls the interface between the separated fluid components in the annular separation passage to a desired location. The preferred outflow channel height relationship that enables this water pressure equilibrium is given by the general static equation ρ₂g₂h₂= Ρ₃g₃h₃Where the first height or radius of the first outflow channel is h₂, The second height or radius of the second outflow channel is h₃And Correlated h₂And h₃Is selected so as to provide a suitable and suitable pressure balance to the separable composite fluid that is separated therethrough into each fluid component. Another variable in the above equation is, for example, ρ representing the density of each of the separated fluids in the first and second outlet channels.₂And ρ₃Or a value that depends on the fluid, such as g₂And g₃Are relatively unselectable and / or generally less important, and are relatively influential values in the equation. g₂And g₃Is a gravitational acceleration value representing an average g value on each side, and is not a substantially equal value in normal operation but is an approximate value (even if there is a difference, usually g₂And g₃Is relatively small). Thus, the drive is dominant and the selectable difference is the correlated height h₂And h₃And these are simply chosen to absorb the difference of the other variables ρ or g.
[0010]
Thus, for complex fluids such as whole blood, if the respective densities of the separable components such as plasma and RBC are known (within a sufficiently controllable range), the respective height h₂And h₃Can be selected such that the position of the interface between the separated components is properly set. Thus, this interface is maintained at a desired location (preferably in the separation passage) even though the composite fluid continues to flow in and out substantially continuously and the separated components continue to flow out in a substantially continuous manner. Dripping. It should be noted that these "heights" are preferably measured radially inward from the reference circle toward the central axis, but the inflow and outflow channels need not be arranged on a radial path That is. Non-radial and circuitous flow paths are also effective and can achieve the pressure drive and balancing relationships described herein. Further, although there is no particular limitation on the reference line or circle serving as a starting point when measuring the “height”, it is preferably in the fluid path, where a separation component having a heavy phase (eg, RBC) The exit from the peripheral channel will be described.
[0011]
Other relationships derived in the same way, in particular with regard to the dynamic forces of the fluid flow in the present invention, are also used in the system according to the invention. For example, a further preferred feature of the present invention relates to a favorable relationship between the fluid pressure at the outlet and the pressure at the inlet, especially when they are at the height or length (h₁) As well as the height or length (h₂And h₃) Is affected by the selection. Where the fluid pressure ρ at the inlet₁g₁h₁Is at least the fluid pressure ρ at the outlet₂g₂h₂Or ρ₃g₃h₃If either is greater, the fluid will continuously flow forward. The following equation illustrates this relationship:
ρ₁g₁h₁> Ρ₂g₂h₂Or ρ₁g₁h₁> Ρ₃g₃h₃
This relationship determines the general force of the fluid flow in one direction from the initial receiving / receiving area to the separation passage and to each component recovery area.
[0012]
Both the foregoing general description and the following detailed description are exemplary, and are merely illustrative of the preferred embodiments of the present invention, and are intended to limit the scope of the invention, which is defined by the claims. wide. These and further described features of the invention will be more clearly disclosed by the detailed description with reference to the accompanying drawings. Although the accompanying drawings are plural, similar components are denoted by the same reference numerals.
[0013]
BEST MODE FOR CARRYING OUT THE INVENTION
A pressure-balancing separation device according to the invention, having no loop and not sealing by rotation, is disclosed in the accompanying drawings and is designated by the reference numeral 10. Although processing of other complex fluids is possible, these preferred embodiments process whole blood as a preferred example of decoding fluid. Although red blood cells (RBC) and plasma are mainly described as components suitable for separating from whole blood, buffy coat, platelets or white blood cells, etc., can also be treated as targets for separation and recovery.
[0014]
As illustrated in FIG. 1, which includes a donor 11, a separation system 10 typically includes a tube system that includes one or more tubes 18, 19, 20, and 21 and reservoirs or bags 22, 23, and 24 connected thereto. A centrifugal separator 14 provided with a motor base 16 and a motor base 12 are provided. Separation conduit 26 is also shown as part of tube system 16. One set of suitable tube systems consisting of tubes 18-21, bags 22-24 and conduits 26 is shown in more detail in FIG. 5 (see discussion below). These major components, and optional tubes and associated components, are described further below. Optionally, an anticoagulant (A / C) is preferably used, and the A / C may be added at the time of collection (see A / C assembly 99 shown in dashed lines in FIG. 1). The coagulant may be pre-packed in the whole blood collection bag 22 (not directly shown) and / or added later (after removal from the donor) and / or directly donated blood as shown in FIG. It may be unnecessary when pumping from a person.
[0015]
In the preferred embodiment, the motor base 12, also referred to as the drive of the separation device 10, is preferably of a tabletop size and is a readily movable magnet (or another drive) that produces a rotating magnetic field in a magnetized embodiment. Formula) device. The motor base 12 can generate this rotating magnetic field, for example, by one or more magnets that physically rotate or rotate about a vertical axis of rotation. Alternatively, the magnetic field can be generated by charging one or more magnets or electromagnetic coils in a controlled rotation sequence, as is generally known in the art. Further, other drive mechanisms may be employed. As a non-limiting example, the motor base 12 may have a spindle or notch-shaped protrusion housing (both not shown) extending therefrom, which are located at the bottom of the rotor 40 of the centrifuge 14. It is designed to engage a corresponding spindle housing (FIG. 15 shows an example of a spindle housing; described below) or a notch-shaped protrusion (not shown). Then, the motor base 12 rotates the corresponding member, and the rotor 40 may be rotated by the mechanical agreement.
[0016]
In any event, the centrifuge 14, which may also be referred to as the centrifuge portion of the separation device 10, is desirably (but not necessarily) self-contained and removable to easily couple with the motor base 12. . Preferred forms for easy bonding are as follows. The motor base 12 is preferably a flat-topped device, which produces a rotating magnetic field extending from its flat surface 13. Next, the centrifuge 14 preferably has a flat bottom so that it can be easily arranged in cooperation with the top plane 13 of the motor base 12 or simply on top plane 13 thereof. In this way, the preferably flat bottom surface 15 of the centrifuge 14 can be arranged in such a way that the whole surface is in contact with the upper flat surface 13 of the motor base 12. In the preferred embodiment, the two surfaces in full contact are substantially horizontal. The axis of rotation (see the description with respect to FIGS. 3 and 4 below) is preferably substantially perpendicular to the top plane 13 of the base 12 and the bottom plane 15 of the centrifuge 14 and thus substantially in the illustrated embodiment. Perpendicular to the horizontal plane.
[0017]
As shown in FIG. 1, the centrifuge 14 may have an outer housing 30 and an inner rotor 40. In a broad sense, the outer housing 30 preferably includes a bottom wall 32 (the outer surface of which is the bottom plane 15 described above), a peripheral wall 34, and a top wall or lid 36. The bottom wall 32 and the peripheral wall 34 are preferably continuous and are preferably at least partially integrated or integrally formed, although separately formed elements may be subsequently combined. In each case, these walls can (but need not) form a fluid-tight structure. The lid 36 simply covers the rotor 40 to cover the peripheral wall 34, preferably in a fluid-tight configuration, or not necessarily in a fluid-tight configuration, to keep the tube and bag system 16 therein during rotation. It is arranged as follows. Although preferred in one embodiment, the invention does not require the housing 30 to be fluid-tight, and furthermore, in operation, the tube and bag system 16 is fluid-tight, and this system 16 is described below. This is not necessary as long as it is sufficiently held in the rotor 40 during rotation.
[0018]
As shown in FIGS. 1-3, a suitable rotor 40 is generally divided into four parts; a separation area 41 to complete the separation, a whole blood storage area 42, and an RBC (red blood cell) preferably. An RBC area 43 collected in a storage container (see below) and a plasma area 44 for collecting plasma. The separation or separation area 41 of a suitable internal rotor 40 of the centrifuge 14 is illustrated in more detail in FIGS. 2 and 3 (see also FIGS. 7 and 8 below). In the present embodiment (FIG. 2), the separation part 41 is a part or all of the peripheral separation flow path 50 of the rotor 40 or includes the same. As shown here, the separation 41 is preferably formed by a rotor 40 that drives the flow forward by fluid pressure and controls the component interface by pressure balancing, as shown in FIG. One. Thus, the rotor configuration includes a compound fluid containing pocket / area 42, substantially in its center, that communicates fluid to the radial transport channel 46 via the intervening radial inlet port 48. The radial transport channel 46 preferably branches at an inlet 49 and extends radially outwardly toward a substantially annular peripheral separation channel 50. The term annular and peripheral is used herein to describe a flow path that is at or near the annular outer periphery of the rotor 40 and that revolves around a somewhat annular path, with the exception described below. The transport flow path 46 (or the inflow path 46) opens to the peripheral separation flow path 50, and the fluid flows in in communication therewith. The peripheral flow path 50 runs from the fluid intersection with the radial transport flow path 46 at the inlet 49 toward each of the outlet areas 51 and 52 of the flow path 50 so as to substantially surround the outer periphery of the rotor 40. The outlet areas 51 and 52 will be described in detail later, but it should be noted that first, fluid flows into these areas by the peripheral flow path 50, and thus the RBC and plasma collection pockets / areas 43 from the respective outlet areas 51 and 52 respectively. , 44, the fluid flows into each of the two independent outflow channels 53, 54. That is, the outflow channel 53 communicates with the RBC collection area 43 via the outlet 55. Similarly, the channel 54 communicates with the plasma collection area 44 via the outlet 56. In addition, the cross-sectional view of FIG. 4 shows a radial transport channel 46 extending from the composite fluid storage area 42 to the peripheral channel 50. FIG. 4 also shows a cross section of the first outflow channel 53 extending inward from the peripheral flow path 50 toward the first outlet 55 and a cross section of the second outflow channel 54 extending inward toward the second outlet 56. ing.
[0019]
The channel 50 has a preferred helical shape, with the outlet region for the heavy separation component (region 51 in the figure) located radially outside the outlet region (52) for the lighter phase. Separation and flow dynamics according to this configuration are further described below.
[0020]
As previously shown in the cross-sectional views of FIGS. 1-3 and 4, each of the whole blood / combined fluid containing area 42 and each of the channels 46, 50, 53 and 54 are preferably provided by substantially vertical walls. Is defined. That is, the peripheral wall 62 defines the containment area 42, the radial walls 64, 65 define the radial transport channel 46, the substantially circular inner and outer respective walls 66, 67 define the peripheral channel 50, One outflow channel walls 72, 73 define a first outflow channel 53, and second outflow channel walls 74, 75 define a second outflow channel 54. In general, adjacent walls are preferably contiguous with each other, and thus between the adjacent walls 64 and 66 and 65 and 66 at the corner edges, ie, at the intersection of the radial flow path 46 and the peripheral flow path 50. At the diversion areas, such as areas 76, 77 or corner edges located at Although several edges are shown in the figure, adjacent walls may be integral with each other, or the inner circular wall 66 and the inlet channels 64, 65 may join, ultimately defining the inlet / inlet area 49. More preferably, they are merged in stages, as shown by the chamfered walls 76, 77 (see FIGS. 2 and 3) at the point where they join together.
[0021]
Preferably, the protruding lips or shelves 60 and 70 (not shown in FIGS. 1-4; see FIGS. 6A, 6B and 6C) are connected to the inflow fluid receiving area 42 and its surroundings (FIGS. 6A, 6B and 6C). Shelf 60) and / or around the outer walls of collection areas 43, 44 (shelf 70 in FIG. 6C) can also be used to retain fluid in areas 42, 43 and / or 44. This will be further described below. Although not shown here, such protruding lips can be disposed on other fluid passages or channels as needed, such as peripheral channel 50. These options are described in more detail below. As an alternative, a ceiling over the top can be provided by a lid 36 (shown open in FIG. 1; shown in dashed lines above the rotor 40 in FIG. 4), which can be used to hold fluid inside. , Areas 42 and / or 43, 44 and / or channels 46, 50, 53 and 54 respectively. Other examples of such ceilings are shown in the alternative embodiments shown in FIGS. 9, 10, and 11A-11D and are described below.
[0022]
As shown in FIG. 4, it is preferable that a metal material 80 is disposed inside the bottom portion 81 of the rotor 40. Preferably, at least one piece of such metal material 80 is disposed therein to cooperate with the magnetic driving force of the rotating magnetic field generated by base 12, preferably in substantially stationary housing 30, The rotor 40 is rotated around a rotation axis 45 (see below).
[0023]
The rotor 40 shown in FIGS. 1-4 can be formed in a variety of ways using a wide variety of materials. Nevertheless, molded plastic is an example of a material that can be easily shaped. Lightweight but resistant members are preferred. This allows the simple design of the pockets 42, 43, 44 and the channels 46, 50, 53 and 54 to be easily arranged in the rotor 40, which is stable in weight, especially with respect to the quasi-spiral channel 50, Here, the outlet 51 is provided radially outward from the outlet 52. The rotor 40 can also be made disposable (e.g., if the rotor 40 is used for blood separation without using the bag set 16), a fluid-tight structure disposed above the rotor 40 in FIG. The lid 36 is used for such a purpose), or, in this case more often, the individual bag set 16 can be used many times and used again and again. Since the bag set completely seals the blood and the blood components contained therein, the rotor 40 does not come into direct contact with the blood. In this case, the rotor 40 may or may not need to be sterilized or discarded at each use.
[0024]
As shown at the top of FIG. 1, the preferred system 10 uses a tube and bag system 16, which is shown in detail in FIG. As shown here, the bag system 16 includes three bags 22, 23 and 24 that connect to a centrifuge conduit 26 via respective tube lines 19, 20 and 21, respectively. The fourth tube line 18 connects the system 16, and in particular the bag 22, to a needle / connection device 17, which can be used to connect the donor / patient 11, as shown in FIG. Of course, after the initial withdrawal, the majority of the tubing line 18 is sealed from the bag 22 with the needle / connector 17 using, for example, a radio frequency (RF) heating sealer (not shown); Disconnect and / or remove. This removal is performed at a portion of the tube line 18 close to the bag 22, as shown by a portion 25 surrounded by a broken line, for example. 6A, 11B and 16 illustrate the sealed end 25a of the tube line 18 after such a cut has been made. As described below, it is desirable that bags 23 and 24 be similarly cut at each tube line, and that bags 22 and 24 be cut from the conduit 26. However, these cuttings are performed after the completion of the centrifugation. In a preferred embodiment, air is introduced into the bag (to allow air to enter bag 22 when whole blood flows out of the bag during use), or (as described below) each separated component is centrifuged during centrifugation. Each of the bags 22, 23 and 24 further has an air vent structure 27 so that air can be evacuated from the bags (as air is evacuated from the bags 23 and / or 24 when entering the bags). A microbial filter (such as 0.2 microns) can be used for the air port 27 to maintain sterility. Furthermore, each bag may be provided with a port structure 28 (see bags 23 and 24 in FIG. 5; not shown in bag 22), in particular, for later use of the recovered separated components. Each bag can be provided with other structures known and / or desired and their use (such as the fragile closed path shown at the bottom of FIG. 16).
[0025]
The configuration of the bag and tube line sections of system 16 can take many known forms and use many known materials. Flexible materials are preferred. For example, RF or heat welded sheet plastics (such as plasticized PVC bags and extruded flexible tubing lines) are desirable (although blow molded or other types of containers (such as glass) and lines may also be used). Can be used). The conduit 26 may be a stretch of deformable plastic sheet welded by RF or heat (see FIG. 16). However, if desired, the conduit 26 may be molded (or formed) into a somewhat rigid device and / or include separate portions, such as a top 26a, a bottom 26b, an inner wall 26c and an outer wall 26d. . Conversely, conduit 26 may be an integrally formed unit (by molding, extrusion, etc.) having no separate parts. For example, the conduit 26 may be a simple tube line that is substantially the same as other tube lines except that the inner diameter may be large. The flexibility of the conduit 26 may be very large, in which case it will be in the shape of the flow path 50 because it is disposed within the flow path 50 during use. Alternatively, its flexibility may be moderate so that it has a particular shape memory or restoring force but can be deformed before, during or after use. The conduit 26 may also be a substantially rigid portion formed into a desired implementation for centrifuging the component elements contained therein.
[0026]
Referring back to FIGS. 1-3 and also with reference to FIGS. 5, 6A, 6B and 6C, the preferred routes of blood and blood component flow when the device 10 is used to separate blood component by component are outlined. First, the flow path preferably passes through the bag and tube set 16 disposed within the rotor 40 (see FIGS. 1 and 6A-6C). However, in some embodiments, a bag set may not be used and the flow simply passes through the flow path and pockets of the rotor 40. In any case, as shown in particular in FIGS. 1 and 5, as a flow path through the tube line, the blood of the donor 11 flows through the needle 17 and the tube line 18 to the bag 22. At this time, the bag 22 may be in the centrifuge 14, but preferably, blood is collected in the bag 22 before disposing the bag 22 in the centrifuge 14. Prior to placement on the rotor 40, the bag 22 may be placed in a separate container (not shown) or hung on a hook (not shown), according to known methods for collecting whole blood from the donor 11. Can be kept. Preferably, as shown in FIG. 1, the tubing line 18 is connected to the bag 22 so that gravity does allow the blood to flow naturally to the bag without a pump. While collecting blood in the bag 22, a temporary outflow stopper or roller clamp (not shown in FIG. 5) by simple connection or slide is used in the line 19. Briefly describing the other tube lines 19, 20 and 21 of the tube system 16 shown in FIGS. 1 and 5, they are disposed in the centrifugal rotor 40 during subsequent centrifugation operations, Used for inflow into and out of conduit 26. Thus, during centrifugation (and preferably after removal from the donor 11 and after cutting from the tube 18 and the needle 17 at the cutting point 25, as described above), After the blood flows from the bag 22 into the conduit 26 and is separated in the conduit 26, the separated blood components, that is, red blood cells (RBC) and plasma are transferred to the containers 23 and 24 via the tube lines 21 and 20, respectively. to recover. RBCs are collected in container 23 through line 21 and plasma is collected in container 24 through tube line 20.
[0027]
Also, as illustrated in FIG. 3, optional clamps or valves 153, 154 may be provided in or adjacent to the flow paths 53, 54, and the flow paths 53, 54 may be turned on until needed, for example, until the rotation speed is sufficient. And the flow in 54 can be stopped. Therefore, these can function as a centrifugal clamp and can be disposed on the rotor 40, and can be automatically operated by setting the minimum rotation speed of the rotor 40 to a predetermined value. Alternatively, the clamps can be manual (typical pre-swing operation) or automated to open and close during (or before or after) rotation by other mechanisms and / or electrical means. it can. A further optional valve 146 may be provided in the inflow channel 46, as further shown in FIG.
[0028]
Prior to or during centrifugation, the tube lines 19, 20 and 21 are preferably located in corresponding flow paths formed in the rotor 40. Accordingly, the flow into the centrifuge 14 of the separation device 10 and the flow through the centrifuge are as follows (whether or not the tube line is introduced as described above). The whole blood of the donor 11, preferably stored in the bag 22 (or collected in another way, such as directly in the rotor 40), is first placed in the composite fluid storage area 42 of the rotor 40. Preferably, empty collection bags 23, 24 are located in collection pockets 43, 44, respectively, and tube lines 19, 20 and 21 are located in flow paths 46, 53, 54, respectively. Also preferably, conduit 26 is located in channel 50. Please refer to FIG. 6A. In the receiving / receiving area 42, the blood is subjected to centrifugal force by rotation of the rotor 40. (Preferably, rotor 40 rotates after whole blood (preferably in bag 22) is placed in or injected into centrifuge 14.) The initial centrifugal force on the blood is It has a rotation axis 45 (FIG. 3 shows a top when the axis is viewed from directly above, and is shown by a chain line in FIG. 4). Due to the centrifugal force of the rotating rotor 40, the blood moves around the storage area 42 (see FIG. 6B) and thus generally transitions into a relationship adjacent to the wall 62 defining the storage area 42. As can be seen in FIG. 6B, the whole blood (denoted by reference numeral 90) is preferably received by either the protruding lip 60 (see FIGS. 6A, 6B and 6C) or the lid 36 (denoted by dashed lines in FIG. 4). It is held substantially vertically within. When a centrifugal force is applied by the rotation of the rotor 40, the blood 90 assumes a quasi-radial shape below the lip 60 as shown in FIG. 6B. In the preferred embodiment, air can flow into the bag 22 as whole blood travels toward the outer wall 62 of the storage area 42, and can flow further as whole blood flows out of the storage area 42 during work. Although not required, air may be allowed to exit the bags as the separated components enter the bags 23,24. Such entry and exit of air is preferably through respective air ports 27 (FIGS. 5, 6A and 6B). By using a microbial filter (e.g., 0.2 microns) for the air port 27, the sterility of the sealed bag system 16 can be maintained.
[0029]
Next, the continuous flow of whole blood 90 exits fluid containment area 42 and proceeds through tube line 19 to radial flow path 46. The blood radially flows outward and flows into the peripheral channel 50. This is shown schematically in FIG. 7, where the arrows indicate the direction of flow through the preferred centrifuge structure. Here, the first radial flow is indicated by an arrow 85, which flows into the peripheral channel 50 and branches in both directions (arrows 87 and 88), exits the separation area 41 and exits 51, 52, The outgoing passages 53 and 54 and the outlets 55 and 56 enter the final route (see FIGS. 2 and 3). The first important point is that when the centrifugal rotor 40 is rotating (it is desirable that the centrifugal rotor is always operating when blood is placed in the rotor), centrifugal force acts on the blood, and as a result, the blood It is separated into two major components, red blood cells (RBC) and plasma. Under such a centrifugal force, the heavy RBCs move outward, and thus gather on the outer wall 67 side of the flow path 50 while continuously flowing around. Such movement is illustrated in detail in FIG. 7, with radial and peripheral flows indicated by arrows in flow paths 46 and 50, respectively. The RBC is indicated by reference numeral 91 in FIG. 7, and the crystal is similarly indicated by reference numeral 92. Also, as shown partially in FIG. 7, component separation is typically performed throughout the time the blood travels around the separation area 41 in the peripheral flow path 50. For this reason, the peripheral flow path 50 can also be called a separation flow path.
[0030]
Further, FIG. 7 shows an arrow 95 indicating that the centrifugal rotation of the rotor 40 is clockwise, and an arrow 87 indicating that the flow of the RBC in the flow path 50 is generally counterclockwise. Although shown, this is not limiting and the direction of centrifugal rotation 95 may be counterclockwise. It is of course possible to make the RBC flow clockwise whether the rotor rotation 95 is clockwise or counterclockwise. Similarly, FIG. 7 shows the rotation of the rotor 40 in a clockwise direction and the plasma flow 88 in a clockwise direction, but in the opposite direction and / or in any combination of these flows. It is possible.
[0031]
Although the flow enters the peripheral flow path 50 and circulates around the flow path, and the RBCs are washed away in the direction of the outer wall 67, most of the flow is separated (see FIG. 7). ) Is preferably continuous throughout. That is, preferably, whole blood continuously flows into the flow channel 50, and similarly, plasma and RBC continuously flow from the flow channel 50. This flow continuity is preferably driven by the relative offset “height” of the inlet and outlet 48, 55 and 56. This will be described in detail below. Here, the term "height" is used in terms of fluid dynamics and fluid pressure balance, such as the rotor of the centrifugal separation area 41 or the annular outer circumference of the fluid flow or similar annular baseline (see outer rotor surface 97). Refers to various fluid distances measured radially inward from a common baseline toward a central axis 45. As an example, reference is made to FIG. 8 in which the flow path portion is broadly shown so that each "height" can be easily understood. More specifically, the height of the radial transport inlet port 48 of the flow path 46 is a "height" equal to the radial length of the radial flow path 46, and in FIG. Distance h to₁It is represented by It is contemplated that the rotor reference circle 97 may be determined substantially arbitrarily (no particular radius is required), the main concept of which is h₁, H₂And h₃Is to provide a substantially common baseline for measuring Nevertheless, one preferred measurement point or reference (among the various possibilities) is the flow path of the fluid, for example the heavy phase / red blood cell outlet from the peripheral channel 50 (indicated by outlet 51). (See a reference circle 97 shown by a broken line in FIG. 8).
[0032]
Next, the height of the inlet port is determined by the specific height (h₁), The height of the outlet port is also the specific height of the outlet channels 53, 54 with respect to the outlet ports 55, 56 (h in FIG. 8).₂And h₃). Next, in order for the fluid to flow / flow from the inlet 48 to the outlets 55, 56, the inlet fluid static pressure ρ₁g₁h₁Is the two static fluid pressures ρ₂g₂h₂And ρ₃g₃h₃Must be greater than either or both (ρ_{(1, 2 or 3)}Is the fluid density, g_{(1, 2 or 3)}Is the acceleration due to gravity or centrifugal force, h_{(1, 2 or 3)}Represents the fluid specific height of each of the above-mentioned flow path inlet ports or outlet ports). Thus, the preferred flow in the direction of the arrows in FIGS. 7 and 8 is:
ρ₁g₁h₁> Ρ₂g₂h₂Or ρ₁g₁h₁> Ρ₃g₃h₃(Equation 1)
[0033]
Furthermore, while generally accurate, this summary has been simplified, and / or, in some respects, somewhat severely. The drive values that can be selected mainly in the present invention are the values of each h as described above. However, although each g, the acceleration value due to gravity or centrifugal force, is a purely indefinite variable (indicated by subscripts 1, 2 and 3), particularly large centrifugal forces are used in the system and From the standpoint that the radial lengths of are different, they are considered to take substantially the same value, at least when considering which values are more important for driving the entire equation. Furthermore, considering the relationship of the driving variables, especially under the practical consequences here (the fluctuation range of h and ρ is larger than the fluctuation range of the value g), the value g in the term indicating the fluid pressure in the above equation becomes , (At least when operating in a substantially common centrifugal range and at RPM) can be considered substantially all uniform. In other words, the difference between the values g is so small that in a suitable centrifugation structure it is meaningless to selectively determine the value h. Similarly, the value ρ is likely to produce significant large differences in the terms in the equation compared to the value g, and the associated value of h is chosen to offset these differences in the design. However, these ρ values are dependent on the fluid flowing through the device and cannot be modified to select or establish the desired configuration. For blood separation, ρ₁g₁h₁Is the density of the composite fluid in the transport channel 46, and in the first embodiment is the density of whole blood before separation, while₂g₂h₂And ρ₃g₃h₃Represent the density of the fluid in the two outlet channels 53, 54, respectively. The blood components separated here are RBC and plasma.
[0034]
Furthermore, the term ρgh indicating the fluid pressure is more accurately calculated when the length is divided into unit parts (for example, when the density of a continuous fluid changes according to the length or the height) or when a plurality of fluids are further divided. When accurately determining the pressure on an arbitrary side, the sum of the factors that cause the factors (eg, Σ (ρgh)_n)it is conceivable that. As a first example, ρ₁g₁h₁The first ρ value at includes both whole blood and the component RBC, and represents the pressure term ρ₁g₁h₁Is actually ρ_RBCg_RBCh_iValue and ρ_{Whole blood}g_{Whole blood}(H₁-H_i) Value (Σ (ρgh)₁). h_iThe value of is shown in FIG. 8 as the height of the interface of the separated RBCs 91 to the separated plasma 92 in or near the intersection 49 of the inflow channel 46 and the peripheral channel 50. The interface between RBC and plasma is indicated by reference numeral 96 in FIGS. Thus, the term indicating the water pressure in the inflow channel 46 is the sum of the values associated with the interface, as shown in the following equation:
ρ₁g₁h₁= Ρ_RBCg_RBCh_i+ Ρ_{Whole blood}g_{Whole blood}(H₁-H_i)
[0035]
The terms used to select each height to produce a suitable forward flow according to Equation 1 are thus more completely determined. For example, Equation 1 can be expressed as:
Σ (ρgh)₁> Σ (ρgh)₂Or Σ (ρgh)₁> Σ (ρgh)₃
[0036]
Similarly, ρ₂g₂h₂The second value of ρ at least includes the plasma and usually also the RBC component, and the pressure term ρ₂g₂h₂Is actually ρ_RBCg_RBCh_iValue and ρ_{Whole blood}g_{Whole blood}(H₂-H_i) Value (Σ (ρgh)₂). Thus, the term indicating the water pressure in the outflow channel 54 is the sum of the values associated with the interface, as shown in the following equation:
ρ₂g₂h₂= Ρ_RBCg_RBCh_i+ Ρ_plasmag_plasma(H₂-H_i)
[0037]
Further, when the boundary surface 96 comes into contact with each of the walls 67, 67 of the peripheral flow path 50, its height h_iIt is the location of the interface 96 between RBC and plasma that is controlled by the present invention so that is maintained within a preferred predetermined range. Therefore, the height h of this boundary surface 96_iIs the fluid pressure ρ₂g₂h₂And ρ₃g₃h₃H such that₂And h₃Are preferably maintained by pre-selecting each of the two heights (generally determined by equation 1 above) to produce a correlation of That is:
ρ₂g₂h₂= Ρ₃g₃h₃(Equation 2)
[0038]
The above creates a hydraulic or hydrostatic pressure such that the interface is maintained at a substantially fixed height regardless of the flow continuously into and out of the flow path 50. But just as important here is that ρ₂g₂h₂Is ρ_RBCg_RBCh_iAnd ρ_{blood Sera}g_plasma(H₂-H_i) (H_iIs again the height of the interface, as shown in FIGS. 7 and 8).₃g₃h₃Is that it is possible to have both RBC and plasma components. Also, Equation 2 becomes more detailed as follows:
ρ₂g₂h₂= Ρ_RBCg_RBCh_i+ Ρ_plasmag_plasma(H₂-H_i) = Ρ₃g₃h₃(Equation 3)
[0039]
Where the pressure term ρ₃g₃h₃Can be thought of as a synthesis of several components, but as described so far, usually consists of a fluid of one component (a component with a heavy phase separated) and thus can be considered more generally (Ρ for isolated RBCs_RBCg_RBCFor example, a single ρg value can be obtained using the average value of g and the average value of ρ).
[0040]
ρ₁g₁h₁> Ρ₂g₂h₂Or ρ₃g₃h₃And ρ₂g₂h₂= Ρ₃g₃h₃In a preferred situation, the flow dynamics is such that, in any case where any part of any of the terms changes, the selected relationship will cause the entire pressure relationship to return to an equational equivalent or to automatically readjust. It is like. Therefore, during operation, ρ₃Changes (decreases or increases), the interface h_iThe flow changes so that moves to offset this change. For example, ρ₂g₂h₂Ρ so that the value of the term increases₃Is increased, ρ₃g₃h₃Increases, possibly due to an increase in flow velocity (or at least due to a change in the previous velocity), at the interface, for example, the term h in a previously established relationship._iAmplify by raising:
ρ₂g₂h₂= Ρ_RBCg_RBCh_i+ Ρ_plasmag_plasma(H₂-H_i)
[0041]
In another embodiment, less dense components (eg, plasma) flow out of one port (plasma port) preferentially at any time, while heavier components (eg, RBCs) have a reduced flow rate or h_iRises sufficiently and the term ρ₂g₂h₂Does not flow until it increases as described above. Furthermore, with the flow stopped, all three sides fluctuate towards equalization (h₁Is ρ (particularly when no fluid is supplied to the inflow passage 46).₁g₁h₁= Ρ₂g₂h₂= Ρ₃g₃h₃, At which point the flow stops, etc.). Thus, when the supply of the composite fluid to the storage area 42 is stopped, the flow is automatically stopped or cut off (the height relationship is generally h.₂> H₁> H₃Is estimated). In any case, even if the flow stops on one or more sides for a period of time, these relationships are adjusted to satisfy the equations. Each term is not always uniform, but is made uniform.
[0042]
In all these embodiments, the configurationally selectable value is preferably the value of h. The fluid to be separated determines the value of ρ, and the value of g is mainly determined by the relevant substances and the centrifugal force applied to the system. Thus, the values that can be selected in determining the relative configuration and size of the desired centrifugation system are:₂And h₃Height or length h of the inflow channel with respect to₁And, similarly, the height h relative to each other₂And h₃It is. Also, the height h of the outlet channel₄And h₅Are also shown in FIG.₄H represents the outlet 51 of the RBC from the channel 50₅It is preferable to select so that it is located radially inward. Furthermore, h₄And h₅And h_iRelative to h so that the boundary surface is maintained within the flow path 50 (although shown as being located with respect to two different reference circles)._iIs h₅And h₄Is preferably located below the The above is the preferred definition of the quasi-spiral configuration of the flow path 50 about the axis 45 (see FIG. 8).
[0043]
Controlling interface 96 according to equations 2 and 3 provides distinct advantages. First, if the interface 96 is not so controlled, it will sink radially outward along the wall 67, whereby the separated plasma will eventually enter the RBC outflow channel 53 and the outlet 55 Undesirably, it flows into the collection area 43 and dilutes the RBC product. Alternatively, the interface 96 may extend radially inward along the wall 66 and become too high. In that case, the buffy coat component and / or the RBC enter the plasma outlet 56 and further to the plasma collection area 44. Blood components, called "buffy coats", generally collect at the interface, as is known. Buffy coat usually contains platelets and white blood cells. Also, if the interface 96 is not controlled and maintained a sufficient distance from either of the outlets 55 and 56, these buffy coat components can penetrate and contaminate either the RBC or the plasma product. Since leukocytes (WBC) may be contaminated with certain pathogens, including contamination with HIV virus, leukocytes are not particularly required to be contaminated with both RBC and plasma products. However, centrifugation is not very effective at separating WBCs from RBCs, so WBCs are often separated separately from RBCs by filtering after (or before) centrifugation. In other words, the present invention, like other centrifugation systems, is not as effective in reducing the white blood cells of red blood cells. Rather, the buffy coat containing WBCs will preferably collect in the RBC layer, but will not be sufficiently separated from the RBCs to produce an RBC product with reduced white blood cells. However, the interface h_iAs long as the height of the buffy coat is well controlled as described herein, the buffy coat containing WBC is well separated from the plasma product by centrifugation according to the present invention. Since the buffy coat is sufficiently retained in the conduit 26 (especially by the automatic shut-off function described above), it is not possible to collect the buffy coat and further separate it into components (such as platelets) for future use such as blood transfusion. It is possible.
[0044]
In any case, when whole blood 90 is separated into its components, particularly RBCs 91 and plasma 92, through separation channel 50, these components 91 and 92 are passed through their respective outlets, outlets 55 and 56. It flows out to the collection areas 43 and 44. Here again, although this is usually a batch process, the flow during separation is continuous, and the whole blood 90 during processing is continuously connected to the centrifugal separation structure, particularly to the separation section 41 of the flow path 50 of the centrifugal rotor 40. , Where it is continuously separated into blood components 91 and 92, and from the separation part 41 of the centrifugal flow path 50 which is a centrifugal separation structure, flows out of the rotor 40 through outflow paths 53 and 54 and outflow ports 55 and 56. It continuously flows out to the respective collection areas 43 and 44.
[0045]
Specifically, FIGS. 6B and 6C, which show the above-described embodiment, show that the flows through the outlets 55 and 56 (also referred to as inlets 55 and 56 to the containers) and the tube lines 21 and 20 of the RBC and the plasma respectively are final Specifically, a state where the storage bags 23 and 24 are connected to each other is shown. In the embodiment shown here, the fluid is still in the centrifuge zone, and the driving force of the fluid pressure and its equilibrium create a flow from the storage area 42 to each of the recovery areas 43,44. Therefore, the driving force by the pressure causes the fluid from the flow path 50 and the conduit 26 to flow into the tube lines 21 and 22, which are the outlets of the RBC and the plasma, and to flow therethrough to the storage bags 23 and 24. The fluid flow pressure that exerts the force, and can also be countercurrent (if necessary or optional) against gravity.
[0046]
Some important advantages provided by the device are: First, the numerous control elements often required in conventional centrifugation systems can be eliminated. For example, the above-described hydraulically balanced interface control described herein eliminates the need for optical or other feedback-based loop interface control elements (including pumps and the like). Control of the pressure balance according to the present invention is substantially independent of blood hematocrit (as long as the donor's hematocrit is in the normal range), and is independent of the relative flow rates of the inlet and outlet. This eliminates the need for complex flow rate calculations and pump and pump-specific control of the flow rate (i.e., computational calculations and multiple flow control pumps can be eliminated; conventional embodiments provide better control of the interface). In order to achieve this, it was necessary to maintain a plurality of pumps, an inlet channel and an outlet channel in a relatively dynamic control relationship by a computer at all times). Therefore, no pump is required at least in the inflow path, and instead, the blood is imbalanced between the centrifugal force of the rotating rotor 40 and the fluid pressure ρ.₁g₁h₁> Ρ₂g₂h₂Or ρ₃g₃h₃According to (Equation 1), the blood is supplied from the whole blood container 22 to the separation channel 50 and the conduit 26. The elimination of the inflow pump and the preferably closed but batch / continuous process and the reduced complexity of the rotational drive structure further eliminates the rotating tube loop. This allows the volume and size of the mechanical components to be reduced (the tube loop of a rotary loop system often determines the minimum requirements and size of the mechanical components), and thus the overall size of the separation device Can be reduced. The closed batch system (without inflow pump) also eliminates the need to provide a rotary seal at the inlet connection of the inflow line to the separator. This greatly reduces complexity and reduces the potential for operational errors. Also, a completely closed system allows for easy assembling of the rotor and the housing, so that it can be easily sterilized and completely removed, or especially in the case of the rotor 40, especially when it is completely closed. If the tube bag system 16 according to the present specification which has been subjected to aseptic treatment is used, it can be reused without sterilization.
[0047]
Another advantage is the quality of the finished product. In particular, the separation device described herein can operate in a range of revolutions (RPM) where the hematocrit product does not substantially vary, so that substantially all of the resulting red blood cell product has a substantially constant maximum hematocrit. Is obtained. For example, the present invention can be operated at such high RPMs that are normally unreachable for a variety of reasons (such as problems with drive structures or tube loops or rotating seals occurring at such high speeds). At such a high speed, substantially all of the RBC is separated from the influent whole blood, thus producing the highest possible hematocrit RBC product. The highest hematocrit is a number greater than 80% and less than 100%, approaching a substantially constant asymptote in the range of about 90 or 95%. At speeds in such a high RPM range, the resulting hematocrit will be substantially equal to the asymptotic maximum over the entire range. At lower speeds (eg, 3000 RPM or less), the resulting hematocrit deviates significantly from the asymptotic maximum. FIG. 6C shows the end of the process or just before the end, where the whole blood bag 22 is substantially empty and the bags 23 and 24 are filled with RBC and plasma products, respectively, preferably and preferably available. This shows a state in which there is almost no remaining amount in the conduit 26 other than the buffy coat product.
[0048]
Here, returning to FIG. 1, some basic modifications will be described. First, it is important to note that in the illustrated embodiment, the collection and centrifugation from the donor / patient or other combined fluid source 11 is not simultaneous. Rather, in the embodiment of FIG. 1, the container of the storage bag 22 containing the complex fluid is first collected, separated from the donor 11, and then centrifuged. If not, use the preferred anticoagulant (A / C), as shown as an option, especially if the complex fluid to be separated using the device 10 is blood. In a preferred variation, during collection, blood from the donor 11 flows through the tube 18 to the bag 22, where it mixes with the A / C to form an anticoagulated blood mixture. A / C is mixed into bag 22 prior to collection. Thus, a direct connection to the donor is possible, as indicated by the solid line in FIG. As will be emphasized here, the present invention can be used in a process (not shown) for separating a complex fluid such as previously collected blood without mixing an anticoagulant. (When blood is collected in advance, such blood is often already subjected to anticoagulation treatment by various methods, and there is no need to add an anticoagulant.) The example uses an anticoagulant system 99 having an A / C container 99a as shown in dashed lines in FIG. 1 that can be integrated into the entire system. In particular, the anticoagulant container 99a can be connected to a tube line 99b, which can be connected to a manifold 99c disposed in fluid communication with the blood infusion line 18. Such manifold connections are known and are frequently used in the art. The anticoagulant is then drawn up by gravity into the tube line 18 or flows in a free flow. The free flow is controlled by careful selection of the inside diameter of the A / C tube line 99b. However, it is preferred to use an anticoagulant pump (not shown) to control the flow of A / C into the infusion line 18. Peristaltic pumps used for this purpose are widely known in the art (others, in particular, linear piston plunger pumps, etc.).
[0049]
As another possible variant of the invention, the separated blood components can optionally be returned to the donor without being held in the collection reservoirs 23,24. An embodiment of returning a certain amount of the separated RBC and / or the separated plasma (or both) to the donor is not shown, but is preferably performed after the completion of the centrifugation process. In this way, the bag 23 containing the separated RBCs and / or the bag 24 containing the plasma can be removed from the rotor 40 and processed, stored or treated in the usual way. Next, when reinfusion of the donor or infusion of the patient is required, an infusion line (not shown) is connected to port structure 28 in a conventional manner (eg, by a spike, needle or other sterile coupling means). Or can be passed. Next, when it is necessary to return a certain amount of the separated component (RBC or plasma) to the blood donor 11 (or to infuse the blood into another patient), the desired component is discharged from each of the containers 23 or 24 and the like. It can be returned to the donor / patient 11 via a return / infusion line (not shown). These special flows are due to the natural flow of the desired blood components from their collection / storage bags 23, 24 by gravity, and / or preferably using a peristaltic pump. In this manner, each return / infusion line (not shown) may be fitted with a pump, respectively, to deliver the desired separated blood components from its reservoir to the donor or patient 11 via each tube. Can be operated in position.
[0050]
As described throughout this specification, the inlets and outlets of the whole blood collection bag 22, like the inlets of the bags 23, 24, preferably do not require internal or external pumps. The flow through tube line 18 is preferably driven spontaneously by gravity, and the incoming flow through tube lines 19, 20 and 21 is preferably driven by the fluid pressure of equation 1 and the centrifugal force acting on rotor 40 by centrifugal drive 12. Is driven by the energy of the centrifugal force acting on the fluid. However, it is also possible to use other driving means for any of these flows. As a first example, peristaltic or other fluid pumps (not shown) can be used to draw blood from donor / patient 11 and supply it to whole blood bag 22. However, this should preferably be done prior to centrifugation, especially if it generates a suction force that exceeds gravity, such as an additional clamping device (not shown) in the outflow line 19 from the bag 22. It is preferred (but not necessary) to use assistive devices. Examples of such fasteners are found in many of the prior art.
[0051]
Similarly, it is preferable to use centrifugal force to cause the separated components to flow into and out of the separation channel 50, but other driving means may be used in combination. . As a first example performed after centrifugation (not shown but described above), the collection bags 23, 24 are arranged at a position lower than the separation part 41 and / or the storage area 42, and then flow by gravity is assisted. Can be moved from the separation channel 50 to the collection bags 23 and 24. In another variation, also preferably after centrifugation, preferably using a peristaltic or other type of external pump (not shown), the separated components are removed from the separation channel 50 through each tube line 20. , 21 can be moved. Such a pump (not shown) serves as a further aid to the other variants described above. A forward force is desired and / or essential to move the remaining fluid from the flow path 50 to the bags 23, 24 after the centrifugation process. Thus, such an optional pump is a desirable aid in centrifugal pressure balanced flow. Alternatively, such a pump can be provided as a sole driving force, and the separated fluid can flow from the separation channel 50 into the bags 23 and 24 via the respective tube lines 20 and 21.
[0052]
Here, a slightly different modification will be described. First, refer to the isometric view of FIG. For example, as compared with those shown in FIGS. 1 to 4, this centrifuge 14a is characterized in that the distinctive separation area 41 of the rotor 40a has a unique function of functioning as recovery areas 43a and 44a as shown in FIG. Is to include a pocket. The aforementioned RBC and plasma collection areas 43, 44 (see FIGS. 1-4) have been changed to substantially rectangular pockets 43a and 44a in the embodiment shown in FIG. 9, and the pockets 43a and 44a are also preferably 9 are obliquely opposed as shown in FIG. 9 (and FIG. 11A, etc., described below) so that the bag can be held during centrifugation. Nevertheless, the function of this embodiment is kept the same as in the embodiment of FIGS. Again, the composite fluid flows from the central storage area 42a to the separation channel 50a and is separated, and the separated components flow into the recovery areas 43a and 44a through the outlet areas 51a and 52a. In FIG. 9, broken lines 53a and 54a represent outflow paths or outflow tube lines connected to the pockets 43a and 44a, respectively. In FIG. 10, the flow path / tube lines 53a and 54a are shown by solid lines.
[0053]
This embodiment shown in FIGS. 9 and 10 is substantially identical in operation to the embodiment shown in FIGS. Rather, the major difference is in the manufacturing stage. While the rotor 40 of the embodiment previously shown in FIGS. 1 to 8 is mainly formed by plastic molding, the deformed rotor 40a of FIGS. 9 and 10 does not require molding, and instead has the form of a sheet such as a plastic sheet. Is manufactured by incision and bonding into a shape such as a pocket 43a, 44a, or by thermoforming, rolling and / or bending to form a circular or substantially circular shape such as a storage area 42a and a peripheral flow path 50a. Formed by forming a circular wall member.
[0054]
Thus, each of the pockets 43a and 44a has a plurality of walls, as shown, including top and bottom walls 43b, 43c and 44b, 44c. Each side wall 43d, 43e and 44d, 44e is also shown in this embodiment (FIG. 9). Notched outlets 55a and 56a, preferably formed in each side wall 43e and 44e, are also shown. The outlets 55a and 56a cooperate with the flow path / tube lines 53a, 54a to form an inflow into each pocket 43a, 44a.
[0055]
Similarly, as shown in FIG. 9, each main portion of the rotor 40a can be easily formed by each wall portion. The cylindrical wall 62a can form the blood storage area 42a, each radial wall 64a, 65a can form a radial inflow channel 46a, and similarly the inner and outer circular walls 66a, 67a The channel 50a is formed. A substantially common floor 47a is illustrated in particular in FIGS. 11A-11D.
[0056]
In operation, the embodiment of FIGS. 9 and 10 operates as described above and rotates about a central axis 45 shown in FIGS. 10 and 11A-D. When a composite fluid 90 such as whole blood is placed in the storage area 42a (see FIG. 11B) and the rotor 40a is rotated, the composite fluid flows from the storage area 42a into the surrounding 50a through the flow path 46a. The composite fluid is separated into components such as the RBC 91 and the plasma 92 in the separation section 41a of the flow path 50a (see FIG. 10) (see FIGS. 11C and 11D). The separated components then flow through each portion of the flow path 50a to respective collection areas 43a and 44a in the manner described for FIGS. 7 and 8 above (arrows indicating the direction of flow in FIG. 10). 85, 87 and 88).
[0057]
Again, a forward flow is created and maintained by each fluid pressure value such that the flow pressure in the inflow passage 46a is greater than the outflow pressure in the flow passages 53a and 54a. The pressure at the inlet is ρ₁g₁h₁Where ρ₁Is the density of whole blood as described above, h₁Is the relative height of the inlet port 48a of the flow path 46a from the external reference circle 97. The outlet pressure for this is ρ (as described above)₂g₂h₂And ρ₃g₃h₃Where ρ₂Is the density of the plasma, h₂Is the height of the plasma outlet port 56a, ρ₃Is the concentration of RBC, h₃Represents the height of the RBC outlet port 55a, respectively. Where h₂Is also ρ_RBCg_RBCh_iWith a variation term for_iIs the height between the boundaries of the separated components in the separation area 41a (not directly shown in FIG. 10, but similar boundaries are shown in FIGS. 7 and 8 above). In any case, ρ₁g₁h₁Is (h_iPreferably with or without changing the outlet pressure value ρ₂g₂h₂And ρ₃g₃h₃It is preferably larger than. This is Equation 1 above. Furthermore, here again, the boundary surface is the fluid pressure uniformity ρ₂g₂h₂= Ρ₃g₃h₃It is maintained at the desired position by (Equation 2).
[0058]
Further processing flow can be seen in the cross-sectional views of FIGS. 11B to 11D. Tube and bag sets, such as set 16 of FIG. 5, are also used for rotor 40a and are disposed within rotor 40a as shown in FIG. 11B. As shown here, a substantially full bag 22 is disposed in the receiving area 42a, and an empty conduit 26 and bags 23, 24 are placed in their respective receiving areas, i. 23 is arranged in the pocket 43a and the bag 24 is arranged in the pocket 44a. A radial tube line 19 is provided in the channel 46a (not shown directly) and the tube lines 20, 21 are passed from the peripheral channel 50a to the respective pockets 43a, 44a, as shown in particular in FIGS. 11B to 11D. As shown in FIGS. 9 and 11B to 11D, the actual receiving channels (dashed lines 53a and 54a in FIG. 9) are not required to hold the tube lines 20, 21. Similarly, although not so shown in FIG. 9, the physical receiving channel 46a defined by the walls 64a and 65a also includes a radial tube line 19 extending from the storage area 42a to the channel 50a. Not required. Thus, it is contemplated that other internal walls (eg, internal flow path walls 66a and / or, in some cases, bottom walls 43c, 44c) may also be omitted. All you need is the relative height h₁, H₂And h₃There is only some structure that keeps the fluid flowing in an annulus in the direction shown in FIG.
[0059]
Nevertheless, FIG. 11B shows the relationship between the rotor 40a and the bag set 16 before centrifugation. Next, FIG. 11C shows the same combination of the centrifugation start word as in FIG. 11B. The whole blood that has entered the bag 22 is pushed by centrifugal force to the outside of the wall 62a that defines the storage area 42a. The lid 36a (FIGS. 11B-11D) may be used to place a vertical restriction on the movement of whole blood within the containment area 42a. Although not shown here, the fluid in the storage area 42a may take a quasi-parabolic shape, for example, as shown in FIG. 6B. As shown in FIGS. 11B-11D, a passageway or structure 27a is provided in and / or through lid 36a to communicate with air port 27 of bag 22 so that, in particular, whole blood can be applied to wall 62a. The air is fed into the bag 22 in the case of moving in the direction of and flowing out therefrom. Here, a microbial filter (e.g., 0.2 microns) may be used to maintain the sterility of bag 22 and system 16. Returning to FIG. 10, blood flowing out of the bag 22 and the storage area 42a flows to the flow path 50a through the tube line 19 and / or the flow path 46a (not shown in FIGS. 11A to 11D). See arrow 85 indicating the direction of flow in FIG. In channel 50a, whole blood (or other complex fluid) is separated into its components (see separation area 41a in FIGS. 7 and 8 above), which then flow through channel 50 in each direction. See arrow 87 indicating the flow of RBC flowing counterclockwise and arrow 88 indicating the flow of plasma flowing clockwise. These directions (or vice versa) can be such that the rotor 40a rotates clockwise (arrow 95) or counterclockwise (not shown). FIG. 11C illustrates a state where the separated RBCs 91 flow into the conduit 26 in the flow path 50a. The separated plasma 92 is also shown in FIG. 11C (not colored). Here, the separated components, ie, RBC 91 and plasma 92, pass through respective tube lines 21, 20 (optionally arranged flow paths 53a, 54a are also shown by dashed lines) in pockets 43a, 44a. The state of flowing into each bag 23, 24 is also illustrated. First, it can be seen from the outside by the centrifugal force that the RBC 91 fills the bag 23 (the plasma 92 also fills the bag 24). Typical h₃And h₂The respective heights are shown in FIG. 11C.
[0060]
FIG. 11D shows the completion of the centrifugation process, in which substantially (if not completely) whole blood (or a similar complex fluid) flows out through tube line 19 and is removed from bag 22. It shows the state where it was turned on. Preferably, air enters through the air port 27 and the outlet structure 27a to substantially fill the bag 22. Bags 23 and 24 are substantially filled with respective components RBC 91 and plasma 92, and preferably have very little fluid (or buffy coat product) remaining in conduit 26 and tubing lines 19, 20 and 21. is there. At this point, the rotation of the rotor 40a is stopped, and the bag set 16 can be removed therefrom. The tubing lines 20, 21 are thermally sealed and / or the collection bags 23, 24 are cut off and separated therefrom, before being subjected to storage (according to the prior art) and / or used for blood transfusion.
[0061]
The inflow of air from the air port 27 formed in the bag 22 causes the bag 22 to have a cylindrical shape, allowing a simple structure in which the composite fluid moves toward the wall 62 of the area 42 and flows out therefrom. become. However, the gas is not exhausted from the bags 23 and 24, and may be exhausted during the processing as described above. In this case, it is needless to say that the air is provided in the bags 23 and 24 after centrifugation. All the air ports 27 need to be sealed to improve storage conditions. Prior to storage or use of the separated components, it is desirable to carry out post-treatments (such as leukocyte reduction, filtering, virus inactivation or addition of preservatives), and such post-treatment is preferably performed after centrifugation is completed. Done.
[0062]
Another variation of the rotor / separation channel structure is shown in FIGS. The implementation of the RBC / plasma separation device described above aimed at processing one unit of whole blood product and the accompanying production and mechanization. According to a preferred embodiment, the rotor is designed to contain approximately one whole blood volume unit or bag 22 and a corresponding collection bag 23,24. A correspondingly sized motor base rotates one such rotor 40 (or 40a in FIGS. 9a and 10) at a time. Such an arrangement provides a preferred simple structure, sometimes referred to as separation next to the patient (ie, separation at or near where the whole blood is donated). However, in some cases, it may be preferable and / or necessary to process larger volumes of whole blood than one whole blood unit at a time. An embodiment in such a case is shown in FIGS.
[0063]
First, FIG. 12 exemplarily shows a state where two independent processing areas 200a and 200b are incorporated in one rotor 240. FIG. 13 and others show that there are four such processing areas (400a, 400b, 400c and 400d) on rotor 440. The letters a, b and FIG. 13 and the other letters a, b, c, and d in the reference numbers of FIG. 12 are generally referred to herein as a plurality of identical elements (for example, 200a and 200b in FIG. 12, and FIG. It is used to distinguish individual processing areas such as 400a, 400b, 400c and 400d). Thus, and also compared to the elements in the above-described embodiments, there was one blood separation channel 50 (and one in the first-described embodiment of the centrifugation structure (see FIGS. 1-4 and 9 and 10 etc.). 50a) is divided into a plurality of opposing flow paths in series on the circumference, for example, 250a and 250b shown on rotor 240 in FIG. 12, and 450a, 450b, 450c and 450d on rotor 440 in FIG. Is done. The two flow paths 250a and 250b of FIG. 12 are preferably opposed so that the material flowing through the flow paths, whether air, blood or other fluid, is independent of the weight at the centrifugal rotor 240. The distribution balances each other (similarly, 450a, 450b, 450c and 450d in rotor 440). Similarly, a similar balance is given to the configuration of the other processing areas (not shown).
[0064]
Further, examples of the configurations of these modifications will be described in more detail. The rotor 240 in FIG. 12 has two independent whole blood storage areas 242a and 242b, into which whole blood to be separated is first injected. Also included are two red blood cell (RBC) collection areas 243a, 243b and two plasma collection areas 244a, 244b. Two independent radial inflow channels 246a, 246b connect the whole blood areas 242a, 242b with the respective semicircular channels 250a, 250b. One end of each of the channels 250a and 250b is connected to each channel for supplying the separated components to the component recovery areas 243a and 243b and 244a and 244b. These channels are more specifically RBC outflow channels 253a, 253b and plasma outflow channels 254a, 254b. As described above, the outflow paths 253a and 253b are supply paths from the RBC outlet areas 251a and 251b of the flow paths 250a and 250b to the respective RBC recovery areas 243a and 243b. Similarly, the two plasma outlet channels 254a and 254b are supply channels that connect the plasma outlet areas 252a and 252b to the plasma collection areas 244a and 244b. Similar structural features are included in other multi-unit processors, as described further below (see FIGS. 13-18 and 19A-19D, etc.).
[0065]
In any case, the basically preferred feature here is, for example, that the RBC outlet regions 251a, 251b connecting to each of the two separation channels are located further radially outward than the respective plasma outlet regions 252a, 252b. Is provided with separation channels 250a and 250b. This feature is more clearly illustrated by reference circle 297, which represents the preferred circular periphery of rotor 240. This also means that the flow passages 250a, 250b extend over the arc of the flow passages 250a, 250b (when viewed from the RBC outlet ports 251a, 251b and the plasma outlet ports 252a, 252b). Spirally inward (as a center) or at least from the inlets to the separation channels from the channels 246a, 246b and inwardly toward the plasma outlet ports 252a, 252b. You can think that it is. Thus, the channels 250a, 250b may spiral outwardly (when viewed from the plasma outlet port to the RBC outlet port) over their entire arc, or at least to the inlet (radial channel 246a) to the channels 250a, 250b. From the intersections 249a and 249b) with the RBC outlet ports 251a and 251b. For the base circle 297, this is h₄> H₅The relationship can be seen. Here, the height h of the boundary surface (not shown)_iAlso preferably h₄And h₅Located between. For example, h_iIs preferably h₄H below the exit indicated by₅(See FIG. 8 and its description). In addition, the relationship between the fluid pressures related to the “height” of the inlet and the outlet (such as the inlet ports 248a, 248b and the outlet ports 255a, 255b, 256a, 256b, etc.) is described in the present embodiment and other plural units described later. The examples are still preferred. In particular, the forward drive relationship is again the same, and the fluid pressure at the inlet must be greater than the combination of fluid pressures at the outlet, especially by a suitable choice of height. Ie;
ρ₁g₁h₁> Ρ₂g₂h₂Or ρ₁g₁h₁> Ρ₃g₃h₃(Equation 1)
[0066]
Again, any or all terms in the pressure ρgh adjust for changes in density and / or differences in the interface of the separated components of one or more fluid components (fluids of the combined or separated components) and the associated density. (See FIGS. 7 and 8 and accompanying description). Similarly, the features of boundary surface control described above apply to these multiple unit embodiments. That is, by keeping the flow pressures at the outlets substantially equal, the boundary surface can be maintained at a desired position in the separation flow paths 250a and 250b. In particular, this is achieved by choosing the height of each outlet port to satisfy the following equation:
ρ₂g₂h₂= Ρ₃g₃h₃(Equation 2)
[0067]
This allows control of the interface. The respective value of h, representing the height of each flow path, is preferably (but not necessarily) uniform to maintain balance throughout the rotor. For example, the height h of each inlet port 248a, 248b₁Are preferably (but not necessarily) the same value. Similarly, the height h of the plasma outlet ports 256a, 256b₂Are preferably the same, the height h of each RBC outlet port 255a, 255b₃The same is true for
[0068]
As mentioned above, FIG. 13 shows an embodiment for a similar multiple unit, having a rotor 440 that includes four processing areas, generally designated 400a, 400b, 400c and 400d. This will be described in detail below. Each reference number of an element for each of the four independent processing areas 400a-d is followed by a lower case alphabetic letter a, b, c, and d so that the same element of the independent processing area 400a-d Shows the identity of distinct but independent elements and distinguishes them.
[0069]
Thus, there are four substantially centrally disposed whole blood receiving / receiving areas or pockets 442a-d, respectively, which are connected to inlet channels 446a-d at inlet ports 448a-d. Channels 446a-d are connected to peripheral channels 450a-d at inlet ports 449a-d. Channels 450a-d are connected to RBC and plasma outflow channels 453a-d and 444a-d via outlet ports 451a-d and 452a-d, respectively. Outflow channels 453a-d and 454a-d are connected to the RBC and plasma collection areas or pockets 443a-d and 444a-d, respectively. Exit ports 455a-d and 456a-d are the final communication sections. FIGS. 14 and 15 show the height of the device for clarity of the preferred independent elements in this embodiment.
[0070]
Here, the relative distance or "height" between the inlet and outlet ports, particularly the inlet ports 448a-d and the RBC and plasma outlet ports 455a-d and 456a-d, is the driving force of the separation process performed here. And functions as a control force. More specifically, the height h of the inlet port₁Is the fluid pressure ρ₁g₁h₁Is the outlet line fluid pressure ρ₂g₂h₂And / or ρ₃g₃h₃(See equation 1 above). Again, the desired modification can be made to the interface (if it occurs at this height) to determine the fluid pressure in or near the inlet line (eg, in or near 446a-d). In order to do more accurately, the height h_iCan use a high density RBC.
[0071]
Therefore, the height that controls the boundary surface (also referred to as the height of the exit port) h₂And h₃Are similarly selected such that the respective fluid pressures exiting are substantially equal. Equation 2; ρ₂g₂h₂= Ρ₃g₃h₃See Also preferably, the height h of each outlet port from a baseline (eg, 497 around rotor 440).₄And h₅Is h₄> H₅Is determined to be. Also, the height h of the boundary surface_iLies between them, ie h_iIs h₄H below the port means by₅Preferably above the port means.
[0072]
As mentioned above, rotors according to these embodiments can be manufactured using any of a variety of methods, including, for example, plastic molding and the like. The mold consists of one or more parts that achieve the configuration as shown above. The use of alternative processing methods and materials, including the use of the formable sheet material shown in the embodiments of FIGS. 9, 10 and 11A-11D, for the manufacture of a multi-unit embodiment (not shown) by unmolding You can also.
[0073]
Further, as the scale increases, for example, as the number of processing areas (400a-d) increases, and / or as the central axis (axis 445 in FIG. 13) increases toward the periphery (peripheral portion 499 in FIG. 13). It may be necessary to use a higher force centrifugal motor base (not shown). However, multi-unit rotors (or other mass rotors, such as rotor 440 of FIGS. 13-15) (or other large numbers, from 2 to about 6, 8, 12, or more units) are typically used in blood banks. It can replace the existing bucket-type or cup-type centrifuge rotors that have been used for blood component separation. Thus, using existing drives to generate forces suitable for separation and flow (e.g., high rotational speed (RPM) and / or large G forces such as 5000 G (5000 x gravity)). Is possible.
[0074]
As an illustration of one means of providing an existing rotor spindle or drive shaft at the effective interface of the rotor 440, a spindle housing 500 is illustrated schematically in FIG.
[0075]
One of the various advantages of these embodiments is found in the tube and bag set 16a of FIG. 16 used herein. The tube and bag set 16a is almost the same as the bag set 16 shown in FIG. For example, both bag sets include three major bags, consisting of a combined fluid / whole blood bag 22 and two separate component bags 23, 24 (RBC is collected in bag 23 and plasma is collected in bag 24); Consisting of associated tube lines 19, 20 and 21 extending from the bags. The difference between the two sets mainly lies in the separation conduits 226/426 to which the tube lines 19, 20 and 21 connect. Preferably, conduit 226 is made in the same manner from the same type of material as the other bags 22, 23, and 24. (As noted above, bags can also be used in the conduit 26 of the embodiment of FIG. 5). However, the conduits 226/426 are primarily composed of selected rotor configurations (separation channels 50, 50a, 250). Or shorter (or longer) and / or wider (or thinner) and / or smaller in volume than any other bag (depending on the length and width of 450 or other portions as desired). (Or bigger). For example, if the width of the edges 26e, 26f (FIG. 16) is further increased (see the arrows shown in dashed lines), the bag / conduit 226/426 will be the rotor 40 or 40a (FIGS. 2-4 and 9-11A etc.), etc. May be further extended so that it can be applied to cover a rotor of the same type.
[0076]
In addition, the buffy coat (leukocytes and platelets) that collects at the RBC-plasma interface, which is normally and continuously separated, is collected and subsequently processed and / or used for conduit 226 (or 26 or FIG. 17). 426) is desirably fixed. An optional connection / connection structure 28a provided to allow optional removal of the contents of the conduit 226/426 after the centrifugation process is shown in dashed lines in FIG. The air vent 27 and / or the connection structure 28 can also be provided in the bags 22, 23, 24 as required. Although not shown in FIG. 16, the air port 27 is preferably connected to the bag 22. Also, as shown in FIG. 16, the tube line 18 connected to the donor is preferably sealed and cut after the completion of one unit of whole blood donation as described above (therefore, the bag 22). Is filled with whole blood). The sealing and cutting line 25a is illustrated. Furthermore, the sealing and cutting areas 25b, 25c and 25d, indicated by dashed lines, indicate the preferred sealing and / or cutting of the lines 19, 20 and 21 after centrifugation. Cutting and / or sealing is also performed on a plurality of other tube lines. The bag 22 of FIG. 16 further shows a severable connector 29. By using the connector 29, the bag 22 is first closed so that the fluid does not flow into the tube line 19, and then the fluid can flow from the bag 22 into the tube line 19 by cutting the connector 29. Here (or in other tube lines 20,21, etc.) other anti-flow members (not shown) may be used, such as slides, roller clamps or hemostats.
[0077]
FIG. 17 shows a state in which the set 16a according to the embodiment is disposed in the processing area 400c according to the embodiment. Specifically, the composite fluid bag 22 is disposed in the storage / reception area 442c, and the tube line 19 connected thereto is disposed in the transport channel 446c. Similarly, the collection bags 23 and 24 are disposed in the respective collection areas 443c and 444c, and the tube lines 21 and 20 connected thereto are disposed in the respective flow paths 453c and 454c. As shown here, the separation conduit 426 is disposed in a corresponding peripheral separation channel 450c.
[0078]
As shown in more detail in FIG. 18, an extension member 554 (shown in dashed lines in FIG. 18) can optionally be used to secure the extension to the inside of the flow path 454c, thereby providing a corresponding fluid pressure It can be ensured that the length or height of the term has an appropriate value. Therefore, the height h measured from the base line 497 indicated by the broken line₂Is secured by the extension member 554. The value of the inlet fluid pressure of the flow path 446c, that is, h₁And / or h₃Similar extension members 556 and 553 can be used to fix each of the fluid pressures at the RBC outlet of the flow path 453c, as indicated by. Although not shown in FIGS. 12-15, 17 or 18, lips or shelves (such as shelves 60, 70 of FIGS. 6A, 6B and 6C) may be used in these multiple unit embodiments to transfer fluid. It can also be held in each area and / or channel. In these multiple unit embodiments, the lid (see lid 36 in FIGS. 1-4) can be used for similar purposes.
[0079]
In any case, a suitable processing method using the processing area 400 is shown in FIGS. 19A to 19D. For example, FIG. 19A shows a state in which the composite fluid 90 is disposed in a general storage area 442. As discussed above, a bag set is preferred but not required and is not shown in FIGS. 19A-19D (but FIG. 19A illustrates a bag set 16 or 16a (FIG. 17) including a bag 22 filled with whole blood. (Refer to FIG. 7) immediately after being attached to the separation area 400 or to the other related areas 442, 443, 444 and 450). A detent member or valve (such as severable connector 29 of FIG. 16) is used in port portion 448 between containment area 442 and flow path 446 to open (or cut in the case of severable member 29). This allows the fluid to flow into the flow path 446. As shown by the dashed lines in FIG. 19A, optional clamps or valves 653 and 654 may be disposed within or near the flow paths 453, 454 to allow flow path 453, Prevents fluid from flowing into 454. These can therefore be referred to as centrifugal clamps and can be arranged on the rotor 440 and set to operate automatically when the rotor 440 reaches a predetermined minimum rotational speed. Alternatively, these clamps can be actuated manually (typical pre-swiveling operation) or automated by other mechanical and / or electrical means to open and close during (or before or after) rotation. . FIG. 19A shows the system before the start of rotation in which preparation is completed.
[0080]
FIG. 19B shows a situation where the rotor 440 has begun to rotate about the axis 445 and the first inflow has occurred. Fluid flow begins at area 442 and continues through port 448 to channel 446. This flow then passes through flow path 446 and continues through port area 449 to peripheral separation flow path 450. The separation of the heavy phase component and the light phase component from the composite fluid is illustrated in flow path 450. Height h_iIndicate separation. The separated components then flow through the flow paths 453 and 454, although they may be stopped by optional clamp members 453 and 454 until a desired rotation speed set in advance is achieved. Thus, FIG. 19B illustrates an initial flow, the onset of separation, and / or a fluid stagnation condition during which the rotational speed (RPM) rises from zero or a low value to a finally desired high value.
[0081]
On the other hand, FIG. 19C shows a state where the RPM is further increased, in which the separated components 91 and 92 continuously flow from the flow path 450 through the outflow paths 453 and 454 to the collection areas 443 and 444, respectively. (If centrifugal clamps 653, 654 are used, then they are open). Similarly, continuously, the composite fluid 90 flows from the storage area 442 through the flow path 446 to the separation flow path 450. ρ₁g₁h₁> Ρ₂g₂h₂And / or ρ₁g₁h₁> Ρ₃g₃h₃Due to the relationship of (Equation 1), a continuously advancing flow is generated here as well. Thus, h of the inlet port 448₁, Port 455 h₃And h of port 456₂Is the variable chosen to create the forward flow. Separation into heavy and light phases, respectively, also occurs continuously in flow path 450. However, the interface has the same height h_iAnd the buffy coat (white blood cells and platelets) remains at the interface in the separation channel 450 as is generally the case. Again, ρ₂g₂h₂= Ρ₃g₃h₃The relationship of (Equation 2) is expressed by_iUsed to maintain the level. Where h₂And h₃The value is a selectable value. Similarly, and as described above, the flow path 450 may include h₄Is h₅(H₄> H₅) Designed quasi-spirally.
[0082]
Next, when all of the composite fluid 90 flows out of the storage area 442, the rotation of the rotor 440 is stopped, and the flow in the flow paths 446, 453, and 454 is also stopped. This state is shown in FIG. 19D. In fact, if centrifugal clamps 653, 654 are used, they can be automatically closed when the RPM of rotor 440 drops. This prevents the fluid from flowing back into the flow paths 453 and 454, thereby preventing the product from being lost from the collection 443 and 444. Also, a clamping element (not shown) can optionally be used in the flow path 446. Next, when the rotor 440 stops, the separated components 91 and 92 are taken out from the respective recovery areas 443 and 444, respectively. Bags 23, 24 (not shown in FIGS. 19A to 19D) can be used for this removal operation, and tube lines 21, 20 (not shown in FIGS. 19A to 19D) connected thereto can be cut off. (See cutting areas 25c, 25d in FIG. 16), preserving the component products 91, 92, or passing them on to subsequent processing (such as pathogen inactivation, leukocyte reduction, filtering and / or preservative addition), or blood transfusion, etc. Can be used for A buffy coat conduit 426 (not shown in FIGS. 19A-19D; see FIG. 16) is also removed from the separation channel 450 and the content 94 is post-processed, if necessary, for further use, and the content is removed. Platelets or other components of the buffy coat are extracted therefrom. The removal of the contents of such a conduit 426 (or 226 of FIG. 16) is shown in FIG. 16 as optional and can be used in other bags 22, 23 and / or 24 as well. This can be done through structure 28. When using the bag and tube set 16a, the bag / tube lines that are not stored or are not further processed (such as bags 22, tube lines 19, 20, and 21) are removed from the rotor 440, and these are preferably Since it can be discarded after use, discard it. The use of such a disposable set that has been previously sterilized allows the rotor to be used over and over again without having to sterilize again after each use. It also reduces the additional need to manufacture disposable rotors.
[0083]
Here again, simultaneous processing of a plurality of units is carried out according to the method of the present invention, for example, preferably using a rotor 440 which is preferably arranged in an existing centrifuge, in particular in which the rotor can be removed, replaced / substituted. Multiple unit bag sets can be processed in the same or similar manner as described using FIGS. 19A-19D.
[0084]
Other options include, but are not limited to, a number of options such as, but not limited to, the number of processing units and / or the relative placement of various storage and / or collection areas and / or channels on each rotor. Can be executed. The methodology is also diverse. It is therefore evident that these and various further modifications, adaptations and variations of the structure and method of the present invention do not depart from the scope and spirit of the present invention. Rather, the invention is to cover all modifications, adaptations, and variations, which are limited only by the claims herein and their equivalents.
[Brief description of the drawings]
FIG. 1 is an isometric view, partially exploded, of a separation system according to the present invention with each fluid container and a donor in an operable position.
FIG. 2 is an isometric view of the rotor / centrifuge section of the separation device according to the invention, which is part of the embodiment shown in FIG.
FIG. 3 is a plan view of the rotor shown in FIGS. 1 and 2;
FIG. 4 is a cross-sectional view of the rotor shown in FIG. 3 taken along line 4-4.
FIG. 5 is a diagram of the tube and bag system of the embodiment shown in FIG.
6A, 6B and 6C are cross-sectional views of the rotor of FIG. 3 taken along line 6-6, including the tube and bag system shown in FIG.
FIG. 7 is a plan view of a part of the rotor shown in FIGS. 1 to 3;
FIG. 8 is another plan view of the rotor shown in FIGS. 1-4 in a state of use.
FIG. 9 is an isometric view of a rotor / centrifuge that is a variation of the separation system of FIG. 1 and the rotor of FIG. 3;
FIG. 10 is a plan view of a modification of the rotor / centrifuge shown in FIG. 9;
11A, 11B, 11C, and 11D are cross-sectional views of the device shown as a variation in FIGS. 9, 10 taken along line 11-11 in FIG.
FIG. 12 is a plan view of another rotor according to the present invention.
FIG. 13 is a plan view of another rotor according to the present invention.
FIG. 14 is an isometric view of the embodiment of the rotor / centrifuge shown in FIG.
FIG. 15 is a cross-sectional view of the rotor / centrifuge shown as an alternative in FIGS. 13 and 14 taken along line 15-15.
FIG. 16 is a plan view of the tube and bag system used in the alternative embodiment of the present invention shown in FIGS. 12-15.
FIG. 17 is an isometric view, partially in exploded view, of a variation of the rotor / centrifuge shown in FIGS. 13 to 15 having the tube and bag system of FIG. 16;
FIG. 18 is a partial isometric view of a variation of the rotor used in the embodiment shown in FIG.
19A, 19B, 19C and 19D are partial plan views of another embodiment of the rotor / centrifuge shown in FIG. 13 in use.

Claims (64)

A centrifugal separator for separating a complex fluid into components contained therein by centrifugal force,
A composite fluid storage area;
A fluid inflow channel;
A peripheral fluid separation channel,
First and second separated component outflow paths;
A rotor including first and second separated component recovery areas,
The inflow path is disposed so that fluid communicates with the fluid storage area, and the peripheral separation flow path is disposed so that fluid communicates with the fluid inflow path and the first and second separated fluid outflow paths. Wherein the first and second separated fluid outflow paths are disposed in fluid communication with the first and second separated component recovery areas;
The first and second separation fluid outflow passages also have first and second heights such that the heights provide a substantial fluid pressure balance to each separation fluid passing therethrough. Centrifugal configuration, interrelated ,. The first and second height correlations of the first and second separated component outlet channels, respectively, substantially balance the fluid pressure of each separated component flowing through the first and second outlet channels, respectively. The centrifugation arrangement of claim 1, wherein the centrifugation arrangement is determined to control a boundary surface of a separation component in a peripheral separation flow path. The first and second height correlations of the first and second separated component outlets, respectively, substantially balance the fluid pressure of each separated component flowing through the first and second outlets, respectively. ,
ρ ₂ g ₂ h ₂ = ρ ₃ g ₃ h ₃
Is defined as
Here, the first height of the first outlet channel is h _2, the second height of the second outlet channel is h _3, g ₂ and g ₃ represents a centrifugal force acceleration value, [rho ₂ represents the density of the fluid that is separated in the first outlet channel, [rho ₃ represents the density of the fluid that is separated in the second outlet channel, centrifugation arrangement according to claim 1. outlet [rho value of [rho ₂ g ₂ h ₂ is, [rho ₂ g ₂ h ₂ such that the sum of [rho _{first component} g _{first component (h} 2 -h) and [rho _{second component} g _{second component} h _i , A first component and a second component from the first and second components, wherein _hi is the height of the interface between the first and second separated fluid components. The described centrifugation configuration. The centrifugation configuration of claim 4, wherein the second separation component is a heavier phase component. The complex fluid to be separated is blood and the ρ value of the first separated component at ρ ₂ g ₂ h ₂ and the ρ value of the second separated component at ρ ₃ g ₃ h ₃ include plasma and red blood cells (RBC) 4. The centrifugation configuration according to claim 3, wherein the ρ value has a different relationship depending on each term so as to represent each density of the separated components of blood. The second [rho values in [rho ₂ g ₂ h _2, as [rho ₂ g ₂ h ₂ is the sum of [rho _RBC g _RBC h _i and [rho _plasma g _{plasma (h} 1 -h _i), plasma and RBC components It includes, where h _i is the height of the interface between the RBC and plasma, centrifuge arrangement according to claim 6. The first and second separated component outflow paths, which drive the composite fluid in the separation flow path and supply each other with a fluid pressure driving force for flowing each separated component in each of the first and second outflow paths. The centrifuge of claim 1, wherein the correlation between the first and second heights and the height of the inflow path, respectively, is determined to control the driving force of the composite fluid and the separation component in the peripheral separation flow path. Constitution. The height of the inlet channel is h _1, the first height of the first outlet channel is h _2, the second height of the second outlet channel is h _3, g _1, g ₂ and g ₃ represents the value of the centrifugal force, ρ ₁ represents the density of the fluid in the fluid inlet, ρ ₂ represents the density of the separated fluid in the first outlet, and ρ ₃ is the density of the separated fluid in the second outlet. It represents the density of the fluid, these values being mutually dependent on the dynamic pressure ρ ₁ g ₁ h _{1 of} the rotor input fluid and the dynamic pressure ρ ₂ g ₂ h ₂ and ρ ₃ g ₃ h ₃ of the _two output fluids. Kayori increases, i.e. _{ρ 1 g 1 h 1> 1} ρ 2 g 2 h 2 or _{ρ g 1 h 1> ρ 3} g 3 h 3
The centrifuge arrangement of claim 1, wherein the fluid flows from the inlet to the outlet of the rotor. The inflow ρ value at ρ ₁ g ₁ h ₁ is the density of the inflow composite fluid to be separated, while the outflow ρ value at ρ ₂ g ₂ h ₂ and ρ ₃ g ₃ h ₃ is the density of each of the separated fluid components. 10. The centrifugation configuration according to claim 9, wherein the ρ value has a different relationship depending on each term. outlet [rho value of [rho ₁ g ₁ h _1, as [rho ₁ g ₁ h ₁ is the sum of [rho _{composite fluid} g _{1 (h} 1 -h) and [rho _{first component} g _{first component} h _i, complex fluid And a first and second element from the first separated component, wherein _hi is the height of the interface between the first and second separated fluid components. Separate configuration. The centrifuge arrangement of claim 11, wherein the first separated component is a heavier phase component. The complex fluid to be separated is blood and the first ρ value at ρ ₁ g ₁ h ₁ is the density of whole blood, while the _second and the _{second at} ρ ₂ g ₂ h ₂ and ρ ₃ g ₃ h ₃ . 10. The centrifugation configuration according to claim 9, wherein the ρ value has a different relationship depending on each term so that the ρ value of 3 represents the density of the separated components, plasma and red blood cells (RBC). first [rho values in [rho ₁ g ₁ h _1, as [rho ₁ g ₁ h ₁ is the sum of ρ _RBC g _RBC h _i and [rho _{whole blood} g _{whole blood (h} 1 -h _i), whole blood and it includes a RBC components, where h _i is the height of the interface between the RBC and plasma, centrifuge arrangement according to claim 13. [rho ₁ value in [rho ₁ g ₁ h ₁ term, [rho ₁ g ₁ h ₁ such that the sum of the _{first component} g _{first component} h _i and [rho _{composite fluid g 1 ρ (h 1 -h i} ), Having two distinct components derived from a combination of independent fluid pressure terms, where _hi is the height of the interface between the first and second separated components;
[rho ₁ g ₁ h ₁ = [rho _{first component} g _{first component} h _i + [rho _{composite fluid g 1 (h 1 -h i)} > ρ _{first component g 3 h 3 = ρ 3 g} 3 h 3
The centrifugation configuration of claim 9, wherein A composite fluid to be separated is the blood, the separated components are red blood cells (RBC) and plasma, where [rho [rho ₁ value in ₁ g ₁ h ₁ term, ρ ₁ g ₁ h ₁ is [rho _RBC g ₃ h _i and ρ _{whole blood} g ₁ (h ₁ −h _i ) have two separate components derived from a combination of independent fluid pressure terms, and thus have RBC and whole blood components. and a wherein the height of the interface between the h _i RBC and plasma,
_{ρ 1 g 1 h 1 = ρ} RBC g 3 h i + ρ _{whole blood g 1 (h 1 -h i)} > ρ RBC g 3 h 3 = ρ 3 g 3 h 3
The centrifugation configuration of claim 9, wherein A centrifugal separator for separating a complex fluid into components contained therein by centrifugal force,
A composite fluid storage area;
A fluid inflow channel;
A peripheral fluid separation channel,
First and second separated fluid outflow paths;
A rotor including first and second separated component recovery areas,
The inflow path is disposed so that the fluid is communicated with the fluid storage area, and the peripheral separation flow path is disposed so as to be in fluid communication with the fluid inflow path and the first and second separated fluid outflow paths. The first and second separated fluid outflow passages are disposed so that the fluid communicates with the first and second separated component recovery areas,
The first and second separated fluid outflow passages and the fluid inflow passage also have first, second, and third heights, wherein the height is such that the respective separated and composite fluids passing therethrough can be fluidized. A centrifugal configuration, interrelated, such that a forward flow drive of pressure is provided. Each of the first and second separated component outflow paths for driving a composite fluid in the separation flow path and providing a fluid pressure driving force to flow each separated component in each of the first and second outflow paths; 18. The centrifuge arrangement of claim 17, wherein the correlation between the first and second heights and the height of the inflow path is determined to control the driving force of the composite fluid and the separation component through the separation flow path. Each of the first and second separated component outflow paths for driving a composite fluid in the separation flow path and providing a fluid pressure driving force to flow each separated component in each of the first and second outflow paths; The centrifuge arrangement of claim 17, wherein the correlation between the first and second heights and the height of the inflow path is determined to control the driving force of the composite fluid and the separation component in the peripheral separation flow path. . The height of the inlet channel is h _1, the first height of the first outlet channel is h _2, the second height of the second outlet channel is h _3, g _1, g ₂ and g ₃ represents the value of the centrifugal force, ρ ₁ represents the density of the fluid in the fluid inlet, ρ ₂ represents the density of the separated fluid in the first outlet, and ρ ₃ is the density of the separated fluid in the second outlet. It represents the density of the fluid, these values being mutually dependent on the dynamic pressure ρ ₁ g ₁ h _{1 of} the rotor input fluid and the dynamic pressure ρ ₂ g ₂ h ₂ and ρ ₃ g ₃ h ₃ of the _two output fluids. Kayori increases, i.e. _{ρ 1 g 1 h 1> ρ} 2 g 2 h 2 or ρ ₃ g ₃ h ₃
18. The centrifuge arrangement of claim 17, wherein the relationship is such that fluid flows from the inlet to the outlet of the rotor. [rho ₁ g ₁ flowing [rho value of h ₁ is the density of the flowing composite fluid to be separated, whereas, ρ ₂ g ₂ h ₂ and [rho ₃ g ₃ h fluid components each density outflow [rho values are separated in ₃ 21. The centrifugation configuration according to claim 20, wherein the ρ value has a different relationship for each term to represent: outlet [rho value of [rho ₁ g ₁ h _1, as [rho ₁ g ₁ h ₁ is the sum of [rho _{composite fluid} g _{1 (h} 1 -h) and [rho _{first component} g _{first component} h _i, complex fluid 22. The centrifuge of claim 21, wherein the first and second components from the first and second separated fluid components, wherein _hi is the height of the interface between the first and second separated fluid components. Separate configuration. The complex fluid to be separated is blood and the first ρ value at ρ ₁ g ₁ h ₁ is the density of whole blood, while the _second and the _{second at} ρ ₂ g ₂ h ₂ and ρ ₃ g ₃ h ₃ . 21. The centrifugation configuration according to claim 20, wherein the ρ value is different in each term so that the ρ value of 3 represents the density of the separated components, plasma and red blood cells (RBC). The second [rho values in [rho ₂ g ₂ h _2, as [rho ₂ g ₂ h ₂ is the sum of [rho _RBC g _RBC h _i and [rho _plasma g _{plasma (h} 1 -h _i), plasma and RBC components It includes, where h _i is the height of the interface between the RBC and plasma, centrifuge arrangement according to claim 23. [rho ₁ value in [rho ₁ g ₁ h ₁ term, [rho ₁ g ₁ h ₁ such that the sum of the _{first component} g _{first component} h _i and [rho _{composite fluid g 1 ρ (h 1 -h i} ), Having two distinct components derived from a combination of independent fluid pressure terms, where _hi is the height of the interface between the first and second separated components;
[rho ₁ g ₁ h ₁ = _{first component} g _{first component} ρ h _i + ρ _{composite fluid g 1 (h 1 -h i)} > ρ _{first component} g _{first component h 2 = ρ 2 g 2 h} 2
21. The centrifugation configuration of claim 20, wherein A composite fluid to be separated is the blood, the separated components are red blood cells (RBC) and plasma, where [rho [rho ₁ value in ₁ g ₁ h ₁ term, ρ ₁ g ₁ h ₁ is [rho _RBC g _RBC has two distinct components derived from a combination of independent fluid pressure terms, such that the sum of h _i and ρ _{whole blood} g _{whole blood} (h ₁ −h _i ), thus eliminating the RBC and whole blood components has a where the height of the interface between the h _i RBC and plasma,
_{ρ 1 g 1 h 1 = ρ} RBC g RBC h i + ρ _{whole blood} g _{whole blood (h 1 -h i)> ρ} RBC g RBC h 3 = ρ 3 g 3 h 3
21. The centrifugation configuration of claim 20, wherein 18. The method of claim 17, wherein the first and second heights of the first and second separated fluid outflow channels, respectively, are correlated to substantially balance the fluid pressure of each separated component flowing therethrough. The described centrifugation configuration. The first and second height correlations of the first and second separated component outlet channels, respectively, substantially balance the fluid pressure of each separated component flowing through the first and second outlet channels, respectively. 28. The centrifugation arrangement of claim 27, wherein the centrifugation arrangement is determined to control an interface of separation components in the peripheral separation flow path. The first and second height correlations of the first and second separated component outlets, respectively, substantially balance the fluid pressure of each separated component flowing through the first and second outlets, respectively. ,
ρ ₂ g ₂ h ₂ = ρ ₃ g ₃ h ₃
Is defined as
Here, the first height of the first outlet channel is h _2, the second height of the second outlet channel is h _3, g ₂ and g ₃ represents a centrifugal force acceleration value, [rho ₂ represents the density of the fluid that is separated in the first outlet channel, [rho ₃ represents the density of the fluid that is separated in the second outlet channel, centrifugation arrangement according to claim 27. The complex fluid to be separated is blood, and the ρ value of the first separated component at ρ ₂ g ₂ h ₂ and the ρ value of the second separated component at ρ ₃ g ₃ h ₃ are the separation of plasma and red blood cells (RBC). 28. The centrifuge configuration of claim 27, wherein the ρ value has a different relationship between terms to represent the density of the components. A centrifugal separator used in a fluid separation system to separate a composite fluid into components contained therein by centrifugal force,
A centrifugal drive motor base,
A drive centrifugal rotor housing designed to be located in an operable rotor drive position of the centrifugal drive motor base;
A rotor arranged at a freely rotatable position in the housing,
A composite fluid storage area and at least one component fluid recovery area within the rotor;
A fluid inflow passage also in the rotor,
A peripheral fluid separation flow path and first and second separation fluid outflow paths;
The inflow path is disposed so that the fluid is communicated with the fluid storage area,
The peripheral separation flow path is disposed such that fluid communicates with the fluid inflow path and the first and second separation fluid outflow paths,
At least one of the first and second separated fluid outflow passages is also disposed in fluid communication with the at least one component fluid recovery area;
The first and second fluid outflow passages also have first and second heights, wherein the heights provide a substantial balance of fluid pressure to the respective component fluids passing therethrough. Centrifugal separators related to each other. The centrifugal drive motor base generates a rotating magnetic field, and the rotor includes a magnetically responsive material that rotates with the rotating magnetic field generated by the motor base, so that the rotor cooperates with the magnetically responsive material and the rotating magnetic field The centrifugal separator according to claim 31, wherein the centrifugal separator rotates. The top surface of the centrifugal drive motor base is flat, the bottom surface of the rotor housing is flat, and the flat top surface of the drive motor base and the flat bottom surface of the rotor housing cooperate to enable the rotor housing to operate the centrifugal drive motor base. 32. The centrifuge of claim 31, wherein the centrifuge is designed to be located at a different rotor drive position. A composite fluid separation device comprising a rotor having an axial direction, a radial direction, and an annular direction,
The rotor has an annular outer circumference, and is rotatable around the axial direction;
The rotor also
A substantially centrally located storage pocket,
An inflow passage communicating with the storage pocket,
A peripheral flow path communicating with the inflow path,
An outflow passage communicating with the peripheral flow passage,
Comprising a collection pocket communicating with the outflow channel,
The inflow channel has a typical height h _c , the outflow channel has a typical height h ₁ ,
The heights h _c and h ₁ are
_{h c>} h ₁
A composite fluid separation device having a correlation such that The rotor further comprises:
A second outflow passage communicating with the peripheral flow passage;
A second collection pocket communicating with the second outflow channel;
It said second outlet channel has a typical height h _2,
The height _{h c,} the height _{h 1} and _{h 2} are
_{h c>} h ₁ or h ₂
35. The composite fluid separation device of claim 34, wherein the correlation is such that The rotor further comprises:
A second outflow passage communicating with the peripheral flow passage;
A second collection pocket communicating with the second outflow channel;
It said second outlet channel has a typical height h _2,
The height _{h 1} and _{h 2} are
h ₁ = h ₂
35. The composite fluid separation device of claim 34, wherein the correlation is such that A disposable container system for use in separating a composite fluid into separated components using a separable rotor designed to receive the disposable container system, comprising:
A composite fluid container;
A first separated component container;
With a separation conduit,
A disposable container system, wherein the composite fluid container is connected to the separation conduit by an injection line, and the first separated component container is connected to the separation conduit by a first outlet line. 39. The disposable container system of claim 37, wherein the composite fluid container connects to a line that may be used to connect the system to a donor / patient. Further, a second separation component container is provided,
38. The disposable container system according to claim 37, wherein the second separated component container is connected to the separation conduit by a second outlet line. 38. The disposable container system according to claim 37, wherein at least one of the containers includes a connection port structure. 38. The disposable container system according to claim 37, wherein at least one of the containers includes an air vent structure. 38. The disposable container system according to claim 37, wherein at least one of the containers includes a severable baffle structure. 38. The disposable container system according to claim 37, wherein at least one of said connection lines includes a detent device. 38. The disposable container system according to claim 37, wherein at least one of the containers is a bag of a deformable material. The disposable container system according to claim 44, wherein at least one of the containers is a bag made of a deformable plastic sheet. 38. The disposable container system according to claim 37, wherein at least one of the connection lines is a tube line made of a deformable material. 47. The disposable container system of claim 46, wherein at least one of the connection lines is a tube line made of extruded flexible material. 38. The disposable container system according to claim 37, wherein the conduit is made of a deformable material. 49. The disposable container system according to claim 48, wherein the conduit is a bag made of a deformable plastic sheet. 38. The disposable container system according to claim 37, wherein the conduit is comprised of a resilient material. 51. The disposable container system according to claim 50, wherein the conduit comprises injection molded plastic. 51. The disposable container system according to claim 50, wherein the conduit comprises blow molded plastic. 38. The disposable container system according to claim 37, wherein the conduit is a tube line of a deformable material. 54. The disposable container system of claim 53, wherein the conduit is a tube line of extruded flexible material. A method for separating a composite fluid into component parts, comprising:
A composite fluid storage area;
A fluid inflow channel;
A peripheral fluid separation channel,
First and second separated fluid outflow paths;
A rotor structure comprising a rotor including first and second separated component recovery areas;
The inflow path is disposed so that fluid communicates with the fluid storage area, and the peripheral separation flow path is disposed so that fluid communicates with the fluid inflow path and the first and second separated fluid outflow paths. Wherein the first and second separated fluid outflow paths are disposed in fluid communication with the first and second separated component recovery areas;
The inflow passage and the first and second separation fluid outflow passages also have respective inlet heights and first and second heights, the heights being the respective separation components and composite components passing therethrough. Are associated with each other such that they are provided with substantial fluid pressure flow control;
Filling a composite fluid containing area of the rotor structure with a composite fluid,
Rotating the rotor structure to separate the composite fluid into component parts. 56. The method of claim 55, further comprising recovering the separated component. 56. The method of claim 55, further comprising automatically driving a flow in the separation channel. 56. The method of claim 55, further comprising automatically stopping flow in the separation channel. 56. The method of claim 55, further comprising automatically re-adjusting the flow in the separation flow path by automatically equalizing fluid pressures in the first and second separation fluid outflow paths. 56. The method of claim 55, further comprising recovering the separated component and clamping a flow from the separation channel prior to the separating component recovery step. 61. The method of claim 60, further comprising automatically clamping flow from the separation channel by centrifugal force until a preselected rotational speed is achieved. 61. The method of claim 60, further comprising automatically clamping flow from the separation channel by centrifugal force after recovery of the separated component if a preselected rotational speed is not achieved. Further, when the preselected rotation speed is not achieved, the intermediate phase component of the separation channel is automatically recovered by automatically clamping the flow from the separation channel by centrifugal force after the recovery of the separation component. 61. The method of claim 60, comprising: 56. The method of claim 55, further comprising using a disposable bag and tube set within the rotor structure.