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EP-4483917-B1 - COLLECTION OF MONONUCLEAR CELLS AND PERIPHERAL BLOOD STEM CELLS

EP4483917B1EP 4483917 B1EP4483917 B1EP 4483917B1EP-4483917-B1

Inventors

  • KUSTERS, BENJAMIN E.
  • MIN, KYUNGYOON

Dates

Publication Date
20260513
Application Date
20200303

Claims (7)

  1. A fluid processing system (10), comprising: a centrifuge (16) configured to receive a separation chamber (36) of a fluid processing assembly (12); a plurality of pumps (P1-P6) configured to convey fluids through the fluid processing assembly (12); and a controller (18) configured to actuate at least one of the plurality of pumps (P1-P6) to convey blood into the centrifuge (16) via an inlet (96), actuate the centrifuge (16) to separate the blood in the centrifuge (16) into a red blood cell layer, a plasma constituent, and a mononuclear cell-containing layer, actuate at least one of the plurality of pumps (P1-P6) to convey a portion of the plasma constituent from the centrifuge (16) via a plasma outlet (102) and to convey a first portion of the red blood cell layer from the centrifuge (16) via a red blood cell outlet (104) while allowing a volume of the mononuclear cell-containing layer to increase in the centrifuge (16), actuate at least one of the plurality of pumps (P1-P6) to convey a second portion of the red blood cell layer from the centrifuge (16) via the red blood cell outlet (104) to a red blood cell collection container (F4) of the fluid processing assembly (12), actuate at least one of the plurality of pumps (P1-P6) to convey at least a portion of the contents of the red blood cell collection container (F4) to the centrifuge (16) to convey at least a portion of the mononuclear cell-containing layer out of the centrifuge (16) via the plasma outlet (102) for collection, and actuate at least one of the plurality of pumps (P1-P6) to convey plasma from the centrifuge (16) via the plasma outlet (102) to more fully collect said at least a portion of the mononuclear cell-containing layer without the use of collected plasma.
  2. The fluid processing system (10) of claim 1, wherein the first portion of the red blood cell layer is at least partially returned to a blood source, and the portion of the plasma constituent is partially returned to the blood source.
  3. The fluid processing system (10) of claim 1 or 2, wherein the portion of the plasma constituent is partially conveyed into the centrifuge (16) via the inlet (96).
  4. The fluid processing system (10) of any one of claims 1-3, wherein the portion of the plasma constituent comprises platelet-rich plasma and the plasma conveyed from the centrifuge (16) via the plasma outlet (102) to more fully collect said at least a portion of the mononuclear cell-containing layer comprises platelet-poor plasma.
  5. The fluid processing system (10) of any one of claims 1-4, wherein the controller (18) is configured to prevent blood from entering the centrifuge (16) while said at least a portion of the contents of the red blood cell collection container (F4) is being conveyed to the centrifuge (16) and, after conveying said at least a portion of the contents of the red blood cell collection container (F4) to the centrifuge (16), actuate at least one of the plurality of pumps (P1-P6) to convey additional blood into the centrifuge (16) via the inlet (96), and actuate the centrifuge (16) to separate the additional blood in the centrifuge (16) into an additional red blood cell layer preferably having a thickness that is less than a thickness of the red blood cell layer, an additional plasma constituent, and an additional mononuclear cell-containing layer, wherein the plasma conveyed from the centrifuge (16) via the plasma outlet (102) to more fully collect said at least a portion of the mononuclear cell-containing layer comprises a second portion of the additional plasma constituent.
  6. The fluid processing system (10) of claim 5, wherein the controller (18) is configured to actuate at least one of the plurality of pumps (P1-P6) to convey a first portion of the additional plasma constituent from the centrifuge (16) via the plasma outlet (102) to clear red blood cells from a flow path between the centrifuge (16) and a mononuclear cell collection container (F5) without the use of collected plasma before the second portion of the additional plasma constituent is conveyed from the centrifuge (16), with the red blood cells cleared from the flow path preferably being returned to a blood source.
  7. The fluid processing system (10) of any one of claims 1-6, wherein said at least a portion of the contents of the red blood cell collection container (F4) is conveyed to the centrifuge (16) via the red blood cell outlet (104).

Description

Background Field of the Disclosure The present disclosure relates to collection of mononuclear cells ("MNCs") and peripheral blood stem cells. More particularly, the present disclosure relates to improvements to the MNC transfer and plasma flush phases of an MNC collection procedure. Description of Related Art Various blood processing systems now make it possible to collect particular blood constituents, rather than whole blood, from a blood source (such as a container with previously collected blood). Typically, in such systems, whole blood is drawn from a source, the particular blood component or constituent is removed and collected, and the remaining blood constituents are returned to the source. Whole blood is typically separated into its constituents through centrifugation. This requires that the whole blood be passed through a centrifuge after it is withdrawn from, and before it is returned to, the source. To avoid contamination and possible infection of the source, the blood is preferably contained within a sealed, sterile fluid flow system during the entire centrifugation process. Typical blood processing systems thus include a permanent, reusable centrifuge assembly containing the hardware (drive system, pumps, valve actuators, programmable controller, and the like) that spins and pumps the blood, and a disposable, sealed and sterile fluid processing assembly that is mounted in cooperation on the hardware. The centrifuge assembly engages and spins a disposable centrifuge chamber of the fluid processing assembly during a collection procedure. The blood, however, makes actual contact only with the fluid processing assembly, which assembly is used only once and then discarded. As the whole blood is spun by the centrifuge, the heavier (greater specific gravity) components, such as red blood cells, move radially outwardly away from the center of rotation toward the outer or "high-G" wall of the separation chamber. The lighter (lower specific gravity) components, such as plasma, migrate toward the inner or "low-G" wall of the separation chamber. Various ones of these components can be selectively removed from the whole blood by forming appropriately located channeling seals and outlet ports in the separation chamber. An exemplary method of centrifugally separating and collecting MNCs is described in U.S. Patent No. 5,980,760. In such a procedure, whole blood in a centrifuge is separated into platelet-poor plasma, an interface or MNC-containing layer, and packed red blood cells. The platelet-poor plasma is collected for later use, while the packed red blood cells are returned to the blood source and the MNC-containing layer remains in the centrifuge. When a target amount of platelet-poor plasma has been collected, an MNC accumulation phase begins. During this phase, the position of the interface within the centrifuge is moved closer to the low-G wall, such that platelet-rich plasma and packed red blood cells are removed from the centrifuge while the MNC-containing layer continues to build up in the centrifuge. Portions of the platelet-rich plasma and the packed red blood cells are returned to the blood source, with the remainder of the platelet-rich plasma and packed red blood cells being recirculated through the centrifuge to maintain a proper hematocrit. When a certain amount of blood has been processed, the return and recirculation of the packed red blood cells is ended and a red blood cell collection phase begins. During this phase, recirculation and return of the platelet-rich plasma continues, while the packed red blood cells are conveyed from the centrifuge via an outlet port to a red blood cell collection container for later use. When a target amount of packed red blood cells has been collected, an MNC harvest phase begins. To harvest the MNCs in the MNC-containing layer, the packed red blood cells are temporarily prevented from exiting the centrifuge. At least a portion of the collected red blood cells is conveyed into the centrifuge via the same inlet port by which whole blood had previously been flowing into the centrifuge, which forces the MNC-containing layer to exit the centrifuge via the same outlet as the platelet-rich plasma. The platelet-rich plasma exiting the centrifuge ahead of the MNC-containing layer is directed into the platelet-poor plasma container, with the MNC-containing layer subsequently being directed into an MNC collection container. Following the MNC harvest phase, a plasma flush phase begins. During this phase, plasma from the platelet-poor plasma container is used to flush any MNC-containing layer positioned between the separation chamber and the MNC collection container back into the separation chamber. The MNC-containing layer flushed back into the separation chamber may be subsequently collected by repeating the various phases, until a target amount of MNC product has been collected. Following collection, the MNC product may be treated to further processing, such as e