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EP-4126096-B1 - CONFIGURABLE SYSTEM TO AUTOMATE BLOOD COMPONENT MANUFACTURING PROCESSES

EP4126096B1EP 4126096 B1EP4126096 B1EP 4126096B1EP-4126096-B1

Inventors

  • KUSTERS, Benjamin, E.
  • BROWN, RICHARD, I.
  • MIN, KYUNGYOON

Dates

Publication Date
20260506
Application Date
20210317

Claims (14)

  1. A configurable automated blood component manufacturing system comprising: a durable hardware component (10) comprising a pump station with plurality of pumps (16, 18, 20), a centrifuge mounting station and drive unit (22), an optical system associated with the centrifuge mounting station and drive unit (22), a microprocessor-based controller including a touchscreen (14) for receiving operator input and displaying procedure parameters, hangers (26a-d) for suspending containers (42, 44, 46, 48), a weight scale associated with each hanger (26a-d) configured to send a signal to the controller indicative of a weight of a container (42, 44, 46, 48) supported on an associated hanger (26a-d), a plurality of tubing clamps (24a-c), and a cassette nesting module (36) including a plurality of valves (38a-d) and pressure sensors (40a-c); and a single use fluid flow circuit (12) comprising a separation chamber (52) configured to be received in the centrifuge mounting station and drive unit (22), a fluid flow control cassette (50) configured to be mounted in the cassette nesting module (36), the cassette (50) having external tubing loops (54, 56, 58) engageable with the pumps (16, 18, 20) so that fluid flow through the cassette (50) is controlled by actuation of the pumps (16, 18, 20) and valves (38a-d), and a plurality of containers (42, 44, 46, 48) in fluid communication with the cassette (50) by a tubing segment (L1, L7. L10, L12) associated with each container (42, 44, 46, 48), with one or more of the tubing segments (L1, L7, L10, L12) configured to be received in one of the tubing clamps (24a-c), wherein the controller is pre-programmed to automatically operate the system to perform one or more standard blood processing procedures selected by an operator by input to the touchscreen (14), and the controller is further configured to be programmed by the operator to perform additional blood processing procedures, including receiving input from the operator as to flow rates and centrifugation forces to be employed during a blood processing procedure.
  2. The system of claim 1, wherein the controller is pre-programmed to perform one or more procedures for: production of red blood cells, plasma and buffy coat from a single unit of whole blood; buffy coat pooling; buffy coat separation into a platelet product; glycerol addition to red blood cells; red blood cell washing; platelet washing; and cryoprecipitate pooling and separation.
  3. The system of claim 1, the programmable controller is configured to receive input from the operator through the touchscreen for operating the system to perform a non-standard blood processing procedure.
  4. The system of claim 1, wherein the pre-programmed blood processing procedures operate the system at pre-set settings for flow rates and centrifugation forces, and the programmable controller is configured to receive input from the operator as to one or more of flow rates and centrifugation forces for the standard blood processing procedure to override the pre-programmed settings.
  5. The system of claim 4, wherein the programmable controller is further configured to receive input from the operator to initially accelerate to a first centrifugal force and/or flow rate over a first period of time and then to accelerate or decelerate to a second centrifugal force and/or flow rate over a second period of time.
  6. The system of claim 1, wherein said plurality of containers includes a red blood cell collection container, a plasma collection container, and an additive solution container, and the controller is configured to execute a blood prime stage in which the pump station conveys whole blood from a blood source to the separation chamber to convey air within the fluid flow circuit into the plasma collection container, execute an establish separation stage in which the centrifuge mounting station and drive unit separate the whole blood in the separation chamber into plasma and red blood cells and the pump station and the plurality of valves cooperate to convey separated plasma and red blood cells out of the separation chamber, recombine the separated plasma and red blood cells as recombined whole blood, and convey the recombined whole blood into the separation chamber without conveying whole blood from the blood source to the separation chamber, execute a collection stage in which the pump station conveys whole blood from the blood source to the separation chamber until a total of one unit of whole blood has been conveyed from the blood source to the separation chamber, the centrifuge mounting station and drive unit separate the whole blood in the separation chamber into plasma and red blood cells, and the pump station and the plurality of valves cooperate to convey separated plasma out of the separation chamber and into the plasma collection container, to convey separated red blood cells out of the separation chamber, and to convey additive solution out of the additive solution container, with the separated red blood cells and the additive solution being combined as a mixture and conveyed into the red blood cell collection container, execute a red blood cell recovery stage in which the pump station and the plurality of valves cooperate to convey air from the plasma collection container into the separation chamber to convey separated red blood cells out of the separation chamber and to convey additive solution out of the additive solution container, with the separated red blood cells and the additive solution continuing to be combined as the mixture and conveyed into the red blood cell collection container, execute an additive solution flush stage in which the pump station and the plurality of valves cooperate to convey additive solution from the additive solution container to the red blood cell collection container until a target amount of additive solution has been conveyed into the red blood cell collection container, and execute an air evacuation stage in which the pump station and the plurality of valves cooperate to convey air out of the red blood cell collection container.
  7. The system of claim 6, wherein the fluid flow circuit includes a buffy coat collection container, the whole blood is separated into plasma, red blood cells, and a buffy coat between the separated plasma and the separated red blood cells within the processing chamber during the establish separation and collection stages, and the controller is configured to execute a buffy coat harvest stage after completion of the red blood cell recovery stage and before execution of the additive solution flush stage in which the pump station and the plurality of valves cooperate to convey air from the plasma collection container into the separation chamber to convey the buffy coat out of the separation chamber and into the buffy coat collection container.
  8. The system of claim 1, wherein the controller is configured to actuate the pump station to convey blood from a blood source into the centrifuge mounting station and drive unit, actuate the centrifuge mounting station and drive unit to separate the blood in the centrifuge mounting station and drive unit into plasma, red blood cells, and a buffy coat between the separated plasma and the separated red blood cells, actuate the pump station to convey the separated plasma and the separated red blood cells out of the centrifuge mounting station and drive unit, and actuate the pump station to convey air into the centrifuge mounting station and drive unit to convey the buffy coat out of the centrifuge mounting station and drive unit for collection.
  9. The system of claim 8, wherein said plurality of containers includes a plasma collection container, the controller is configured to actuate the pump station to convey air in the fluid flow circuit into the plasma collection container prior to actuating the centrifuge mounting station and drive unit to separate the blood in the centrifuge mounting station and drive unit, and the controller is configured to actuate the pump station to convey at least a portion of the air in the plasma collection container into the centrifuge mounting station and drive unit to convey the buffy coat out of the centrifuge mounting station and drive unit for collection.
  10. The system of claim 1, wherein said plurality of containers includes a buffy coat collection container, and the controller is configured to actuate the pump station to convey blood from a blood source into the separation chamber, actuate the centrifuge mounting station and drive unit to separate the blood in the separation chamber into plasma, red blood cells, and a buffy coat between the separated plasma and the separated red blood cells, actuate the pump station to convey the separated plasma and the separated red blood cells out of the separation chamber, and actuate the pump station to convey air into the separation chamber to convey the buffy coat out of the separation chamber and into the buffy coat collection container.
  11. The system of claim 10, wherein the separated plasma is conveyed out of the separation chamber via a plasma outlet port, the separated red blood cells are conveyed out of the separation chamber via a red blood cell outlet port, the air is conveyed into the separation chamber via the plasma outlet port, and the buffy coat is conveyed out of the separation chamber via the red blood cell outlet port.
  12. The system of claim 1, wherein said plurality of containers includes a red blood cell source container, a washed red blood cell container, and a waste container, and the controller is configured to execute a priming stage in which the pump station and the plurality of valves cooperate to convey air within the fluid flow circuit into the waste container, execute a washing stage in which the pump station and the plurality of valves cooperate to convey red blood cells from the red blood cell source container to the separation chamber, the centrifuge mounting station and drive unit separate the red blood cells into a supernatant and washed red blood cells, and the pump station and the plurality valves cooperate to convey the supernatant out of the separation chamber and into the waste container and to convey the washed red blood cells out of the separation chamber and into the washed red blood cell container, execute a red blood cell recovery stage in which the pump station and the plurality of valves cooperate to convey air from the waste container into the separation chamber to convey washed red blood cells out of the separation chamber and into the washed red blood cell container, and execute an air evacuation stage in which the pump station and the plurality of valves cooperate to convey air out of the washed red blood cell container.
  13. The system of claim 12, wherein said plurality of containers includes a wash solution container, and the controller is configured to execute a dilution stage in which the pump station and the plurality of valves cooperate to convey wash solution from the wash solution container to the washed red blood cell container until a target amount of wash solution has been conveyed into the washed red blood cell container.
  14. A method of separating blood, using the system of any one of claims 1-13, wherein at least one of the containers (44) is a whole blood container used as blood source.

Description

TECHNICAL FIELD The present disclosure relates generally to blood and blood component storing, treating and/or processing, and related novel apparatus, systems and methods associated with such storing, treating and/or processing. BACKGROUND It is well known to collect whole blood from donors using manual collection procedures through blood drives, donor visits to blood centers or hospitals and the like. In such procedures, blood is typically collected by simply flowing it from the donor under the force of gravity and venous pressure into a collection container (e.g., a flexible pouch or bag). Although various blood collection instruments may be used to aid or expedite the collection of blood or blood components. The collection container in manual collection is often part of a larger preassembled arrangement of tubing and containers (sometimes called satellite containers) that are used in further processing of the collected whole blood. More specifically, the whole blood is typically first collected in what is called a primary collection container that also contains an anticoagulant, such as but not limited to a solution of sodium citrate, phosphate, and dextrose ("CPD"). After initial collection, it is a common practice to transport the collected whole blood to another facility or location, sometimes called a "back lab," for further processing to separate red blood cells, platelet, and plasma from the whole blood, which may including carrying out additional processes, such as cell washing and plasma cryoprecipitate production and collection. This processing usually entails manually loading the primary collection container and associated tubing and satellite containers into a centrifuge to separate the whole blood into concentrated red cells and platelet-rich or platelet-poor plasma. The separated components may then be expressed from the primary collection container into one or more of the satellite containers, with the red blood cells being combined with an additive or preservative solution pre-filled in one of the satellite containers. After the above steps, the blood components may be again centrifuged, if desired, for example to separate platelets from plasma. The overall process requires multiple large floor centrifuges and fluid expression devices. Because of the multiple operator interactions, the process is labor intensive, time consuming, and subject to human error. Thus, there have been continuing efforts to automate the apparatus and systems used in the post-collection processing of whole blood, and recently it has been proposed to employ an automated blood component separator for such post-collection processing, such as a membrane separator (US 2002/0179544 US 2019/201916 discloses an automated blood component manufacturing system comprising a pump station with a plurality of pumps, a centrifuge mounting station and drive unit, an optical system associated with the centrifuge mounting station and drive unit, and a controller including a touchscreen. The system is provided with hangers associated with weight scales for suspending containers, a plurality of tubing clamps, and a cassette nesting module including valves and pressure sensors. The system is further provided with a single use fluid flow circuit comprising a separation chamber to be received in the centrifuge mounting station and drive unit, a fluid flow control cassette to be mounted in the cassette nesting module, the cassette having external tubing loops engageable with the pumps, and a plurality of containers in fluid communication with the cassette. The subject matter disclosed herein provides further advances in various aspects of the apparatus, systems and methods that may be employed in whole blood collection and post-collection processing systems by using continuous flow centrifugation in a system that utilizes a programmable controller that is pre-programed to automatically perform selected back lab processes and may also be programmed by the user to meet needs and requirements specific to the user. SUMMARY The invention is set out in the appended set of claims. For purposes of this description and claims, unless otherwise expressly indicated, "blood" is intended to include whole blood and blood components, such as concentrated red cells, plasma, platelets and white cells, whether with or without anticoagulant or additives. The following summary is to acquaint the reader generally with various potential aspects of the present subject matter, and is non-limiting and non-exclusive with respect to the various possible aspects or combinations of aspects. Additional aspects and features may be found in the detailed description herein and/or in the accompanying figures. By way of the present disclosure, a configurable automated blood component manufacturing system is provided comprising a durable hardware component and a single use fluid flow circuit. The durable hardware component comprises a pump station with plurality of pumps, a