SYSTEM FOR MULTI-PROCESSING AND SEPARATION OF BIOLOGICAL FLUIDS
20180111132 ยท 2018-04-26
Assignee
Inventors
Cpc classification
B04B2005/0485
PERFORMING OPERATIONS; TRANSPORTING
B04B11/02
PERFORMING OPERATIONS; TRANSPORTING
B04B5/10
PERFORMING OPERATIONS; TRANSPORTING
A61M1/3696
HUMAN NECESSITIES
International classification
Abstract
A system for the processing and separation of biological fluids into components comprises an apparatus that cooperates with a disposable set, comprising a cabinet (100) for housing a hollow centrifugal processing chamber (20) of the disposable set. The cabinet comprises a plurality of side-by-side locations (110) for receiving a corresponding plurality of centrifugal processing chambers (20) in side-by-side spaced-apart relation. Each location comprises an individual drive means (52) for driving its centrifugal processing chamber. Remotely-actuable valves (124) associated with the disposable sets are located on the apparatus' cabinet in the proximity of said locations. Valve actuation provides a display of the state of actuation of the valves (124). Selection of this state of actuation is arranged to control connection of the centrifugal processing chamber (20) of each fitted disposable set with a flexible container (200) of the same disposable set or another container, and to contol connection of the centrifugal processing chambers (20) with flexible containers of the same or other fitted disposable sets in different combinations, in particular with series and/or parallel connections.
Claims
1. A system for the processing and separation of biological fluids into components, the system comprising an apparatus that cooperates with a disposable set, the apparatus comprising a cabinet (100) for housing a hollow centrifugal processing chamber (20) of the disposable set, the disposable set comprising: (a) a set of flexible containers (40,42-44) for receiving biological fluid to be separated and separated components, and optionally one or more additional flexible containers (41) for additive solutions, (b) the set of flexible containers being interconnected by tubing associated with valves for controlling the input and the extraction of fluids into or from the containers, and (c) a hollow centrifugal processing chamber (20) rotatable about an axis of rotation and having an axial inlet/outlet (7) for the biological fluid to be processed and for the processed components of the fluid, the processing chamber containing an axially movable member (21) which defines a separation space of variable size for receiving biological fluid, the member (21) being axially movable to intake a selected quantity of biological fluid to be processed into the separation space via said inlet and to express processed biological fluid components from the separation space via said outlet, the hollow centrifugal processing chamber of the disposable set being receivable in the apparatus' cabinet (100), each of said centrifugal processing chambers being rotatable about a central axis of rotation of the centrifugal processing chamber, the cabinet comprising drive means (152) for rotatably driving a hollow centrifugal processing chamber (20) received therein about the central axis of rotation of the centrifugal processing chamber, and means (60-69) for monitoring the position of the axially movable member (21) to control the amounts of intaken and extracted fluids, characterised in that the apparatus' cabinet comprises a plurality of side-by-side locations (110) for receiving in the cabinet (100) a corresponding plurality of centrifugal processing chambers (20) in side-by-side spaced-apart relation, each of said side-by-side locations comprising an individual drive means (52) for driving its centrifugal processing chamber about its centra axis of rotation; the valves associated with the disposable sets are remotely-actuable valves (124) located on the apparatus' cabinet in the proximity of the locations (110) for receiving the respective centrifugal processing chambers (20); and the apparatus further comprises means for actuating the remotely actuable valves (124) individually and by combinations of individual actuations, these valve-actuating means including a control panel (126) that provides a display of the state of actuation whether open or closed of individual remotely-actuable valves (124), the selection of the state of actuation of the individual actuable valves (124) being arranged to control connection of the centrifugal processing chamber (20) of each fitted disposable set with the flexible container of the same disposable set or to another container, and to contol connection of the centrifugal processing chambers (20) with the flexible containers (200) or other containers of several fitted disposable sets in different combinations, in particular with series and/or parallel connections.
2. The apparatus as claimed in claim 1, wherein said valve-actuating means is arranged to provide for: (d) the individual control of the valve(s) (124) associated with at least one disposable set, or all disposable sets whose centrifugal processing chambers (20) are received in the cabinet (100), to separately control the inlet and outlet of fluid from the flexible container(s) (200) of the or each disposable set; (e) the control of the valve(s) (124) associated with at least two disposable sets, or of all disposable sets whose centrifugal processing chambers (20) are received in the cabinet (200), to connect in series the outlet of at least one flexible container (200), or the outlet of all but one flexible container received in the cabinet (100), to the inlet of another flexible container, or vice versa; (f) the control of the valve(s) (124) associated with at least two disposable sets, or of all disposable sets whose centrifugal processing chambers (20) are received in the cabinet (100), to connect in parallel their inlets and outlets; and any combination of (d), (e) and (f).
3. The apparatus as claimed in claim 1 in combination with a plurality of disposable sets, each disposable set comprising a centrifugal processing chamber (20) connected to tubing, the tubing being in Y-configuration with the stem (212) of the Y connected to the centrifugal processing chamber (20), the extremity of one branch (202) of the Y tubing being connected to a flexible container (200) for biological fluids, the extremity of the other branch (208) of the Y tubing being connectable to a container (210) of biological fluid to be processed or to a container of additive, the two branches of the Y tubing having zones that pass though the remotely-actuable valves (124), said zones of the tubing being closable by actuation of the remotely actuable valves (124), said zones being located adjacent to where the two branches (202,208) of the tubing are branched to the stem (212) of the Y.
4. The system as claimed in claim 1, wherein at each location (110) is a specific module which is part of a chain processing where each module has a dedicated role in the processing of a biological fluid, said biological fluid being sequentially transferred from module to module.
5. The system as claimed in claim 1, wherein the valves are electro-magnetically actuable pinch valves located on a substantially flat top (106) of the cabinet (100) in the proximity of the locations (110) for receiving the respective centrifugal processing chambers (20).
6. The system as claimed in claim 5, wherein the top (106) of the cabinet (100) has on its outer surface at locations adjacent to those for receiving the processing chambers, an array of projections (122,124) provided with through-openings (123,125) for guiding the tubing of the flexible containers, and wherein the cabinet's top (106) optionally comprises, in-between and adjacent to the projections of each array of projections (122,124), a visible guide line (150) indicating a path for the tubing of the flexible container (200), which path passes through the projections (122,124).
7. The system as claimed in claim 6, wherein the top (106) of the cabinet adjacent to each location (110) for receiving a processing chamber (20) comprises three generally cylindrical projections, a first projection (122) incorporating an optical line sensor, the first projection (122) having in its top surface a diametral groove (123) for receiving the tubing, and two second projections (124) each incorporating an electromagnetically-actuable pinch valve, the second projections (124) each having a flat face with a lateral through-groove (125) for receiving a tubing, the first projection (122) and two second projections (124) being situated on a generally Y-shaped path for the tubing along the top (106) of the cabinet.
8. The system as claimed in claim 1, wherein the apparatus' cabinet (100) has a substantially flat top (106) and a generally upright outer wall (108) wherein the outer wall of the cabinet comprises, in its upper part, a series of recesses (115) in correspondence with the locations (110) where the processing chambers (20) are received, said recesses (115) each being shaped and configured to receive and support a flexible container (200) of a disposable set on the outer upper wall (108) of the cabinet (100).
9. The system as claimed in claim 1, wherein the apparatus' cabinet (100) has the approximate shape of a D in horizontal section, with a curved outer wall (108) along which and adjacent to which said locations (110) for the processing chambers (20) are distributed.
10. The system as claimed in claim 1, comprising adjacent a flat rear wall of the apparatus' cabinet (100) two upright poles (128) extending above and generally to the rear of the cabinet, said poles having hooks (130) or other attachments for suspending bags (210) of biological fluid to be treated or of additives.
11. The system of claim 10, comprising a touch-screen command (126) supported between the two poles (128) by a central post (129) extending up from the cabinet (100).
12. The system as claimed in claim 1, wherein the apparatus' cabinet (100) has a plurality of from four to fifteen locations (110) for the processing chambers (20), for example six or twelve such locations.
13. The system as claimed in claim 1, wherein the system is arranged to operate in a separation mode and in a non-separation transfer mode, wherein: in the separation mode fluids can be intaken into at least one processing chamber (20) while the chamber is rotating or stationary, fluid intaken into the chamber is centrifuged and separated into components, and the separated components expressed while the chamber is rotating or, optionally, for the last separated component, while the chamber is stationary; and in the transfer mode said at least one processing chamber (20) intakes fluid and expresses fluid with the chamber stationary, the valve-actuation arrangement (124) being actuable to transfer amounts of fluid from one container (200) to another via the processing chamber (20), by axially moving the member (21), without centrifugation or separation of the fluid into components, and said means (60-69) for monitoring the position of the axially movable member (21) controls the amounts of non-separated fluids transferred.
Description
BRIEF DESCRIPTION OF DRAWINGS
[0041] The invention, and a prior art arrangement, will be further described by way of example with reference to the accompanying drawings, in which:
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DETAILED DESCRIPTION
[0057] The processing chamber 20 employed with the apparatus according to the invention is in accordance with that described in EP-B-0 912 250 (C.FELL).
[0058] The piston 21 is made of a transparent material like polycarbonate and is equipped with two O-rings 24 and 25. These O-rings are made of low friction material like silicon. The processing chamber 20 is closed on its bottom side by a cap 22 carrying a bacterial filter 23. Air can pass through central opening 26 and filter 23 in cap 22. The position of the piston 21 can be accurately monitored by an optical sensor assembly 60 and 61 (
[0059] Signal 62 is fed to a low-pass filter 69 and the filtered signal fed to a comparator 67 which also receives from potentiometer 68 a threshold value for discriminating the filtered signal from ambient noise. The output of comparator 67 is connected to the enable gate of counter 65. Clock signal 66 is used to intake the response from each individual pixel of the CCD linear array 61, and feed this to the input of counter 65. The output of counter 65 is connected to a CPU 64 which calculates the position of piston 21 and, when required, shifts the turned-on LEDs 60 via a multiplexer/LED driver 63. Similarly, when necessary, the CPU 64 will vary the signal of compressor driver 70 that supplies compressor 71 in order to increase or decrease pressure applied below the piston 21 to control its position.
[0060] This is only one example of position sensing for the piston 21. The light source 60 could be a filament bulb, or a unique linear source of light. The CCD linear array 61 could be replaced by an array of photosensing devices. The receiving sensing device (61) could be placed also beside the emitting light device 62, the system working in reflection light from the piston 61 rather in transmittance light through the piston 21.
[0061] The disposable set of EP-B-0 912 250 (
[0062] In the prior art arrangement of EP-B-0 912 250, an array of stopcocks was organized in a manifold to allow the connection between the different tubing lines. In the preferred embodiment of the apparatus according to the invention, the stopcocks are replaced by pinch valves which are simpler to manipulate and less expensive. Also, the prior arrangement' has two processing liquid bags for one set of disposables. In the present invention the disposable need only have one processing bag which, together with the use of pinch valves in lieu of stopcocks, considerably reduces the cost of each disposable set and hence the operating cost of the system.
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[0064] The cabinet 100 thus has an essentially flat top 106 and a generally upright outer wall 108 and this outer wall 108 comprises, in its upper part, a series of six recesses 115 in correspondence with the locations 110 where the processing chambers are received. These recesses 115 are generally flat and outwardly flared towards the top. At their bottom end, the recesses 115 have upstanding flaps 116 spaced apart from the rear wall of the recess, forming a pocket for receiving a disposable flat flexible bag of a disposable set.
[0065] Between the recesses 115, the top of sidewall 108 is extended upwardly and inwardly by a series of arms 120 which extend partly between the locations 110 to form partial separators. On the top 106 are a series of arrays of projections 122, 124 that will be further described in connection with
[0066] A central post 129 extends vertically upwards from the rear of cabinet 100, this post 129 supporting a touchscreen command 126 at an adjustable height so the screen can be set at a convenient height for an operator. On either side of the touchscreen 126 are two upright poles 128 extending above and generally to the rear of cabinet 100, these poles 128 being supported by a cross-bar 132 attached to the central post 129. At their top ends, the poles 128 are fitted with hooks 130 for the attachment of blood bags or bags of other biological fluids to be processed.
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[0069] The electromagnetically-operable pinch valves 124 are a known type of solenoid-operated device designed to open and close tubing. Suitable pinch valves are for instance available under the trademark Bio-Chem Valve, see www.biochemfluidics.com. In such valves energizing the solenoid retracts a valve plunger either to open the tubing or closes the tubing. De-energizing the solenoid allows a spring to push the plunger back to its original closed or open position. Energizing and de-energizing the solenoid can be controlled from a distance, namely from the inventive apparatus' control panel 126.
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[0071] The first branch 202 of the disposable tubing stops short of the first projection 122, whereas its second branch 212 passes through the other second projection 124 and extends towards the blood bags 210 to which it is connected in a preliminary operation. The common branch 208 of the disposable tubing leading to the connector 206 of the centrifugal processing chamber 20 is inserted in the groove 123 and passes through the first projection 122, i.e. the optical sensor.
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[0073] Each disposable set preferably carries a code bar identifying the contents of the flexible container 200. The code bar can be read by a hand-held code bar reader. The read information is supplied to the central processing unit of the apparatus. The code bar is indicated on the unit's control screen (
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[0079] In all of the configurations of connection shown in
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[0081] A block diagram of the circuitry for controlling the apparatus according to the invention is given in
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[0084] A typical serial-chain processing example with the system according to the invention would be a chain of volume reduction of cord blood from 220 ml to 100 ml in a 20 minutes processing cycle, followed by an incubation phase of 30 minutes including the addition of a biological additive and finally followed by a washing processing cycle with Sodium Chloride during an extra 20 minutes.
[0085] A parallel processing example with the system according to the invention would include the volume reduction of 3 liters of cell cultured products down to 100 ml including a final washing cycle, with the entire process done in less than 1 hour.