Blood processing systems and methods that employ an in-line leukofilter mounted in a restraining fixture

• US 6,709,412 B2
• Filed: 10/13/2001
• Issued: 03/23/2004
• Est. Priority Date: 09/03/1999
• Status: Expired due to Term

• Current Assignee: Baxter International Inc.
• Original Assignee: Baxter International Inc.
• Inventors: Smith, Kelly B, Kast, Michael J, Vandlik, Mark
• Primary Examiner(s): Bianco, Patricia
• Application Number:
  US09/976,833
• Publication Number:
  US 20020090319A1
• Time in Patent Office: 892 Days
• Field of Search: 422/44-48, 604/4.01, 604/5.01, 604/6-1-, 604/6.07, 604/6.09, 604/6.11, 604/6-5-, 210/645-47, 210/650, 210/739, 210/740-41, 210/744, 210/745, 210/767, 210/781-82, 210/784, 210/787, 210/85, 210/87-89, 210/90, 210/143, 210/145-46, 210/252-56, 210/257--25, 210/258, 210/282, 128/898, 128/905, 128/920, 128/923, 128/DIG.3, 494/36, 494/37, 494/43, 494/45, 494/60, 494/11, 494/85
• US Class Current: 604/6.02
• CPC Class Codes: A61M 1/00 Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems catheters A61M25/00; tube connectors, tube couplings, valves or branch units specially adapted for medical use A61M39/00; devices for taking samples of blood A61B5/15; filters implantable into blood vessels A61F2/01
• CPC Class Codes: A61M 1/0209 Multiple bag systems for separating or storing blood components
• CPC Class Codes: A61M 1/0218 with filters
• CPC Class Codes: A61M 1/30 Single needle dialysis ; Reciprocating systems, alternately withdrawing blood from and returning it to the patient, e.g. single-lumen-needle dialysis or single needle systems for hemofiltration or pheresis
• CPC Class Codes: A61M 1/302 having a reservoir for withdrawn untreated blood
• CPC Class Codes: A61M 1/303 having a reservoir for treated blood to be returned
• CPC Class Codes: A61M 1/308 Volume control, e.g. with open or flexible containers, by counting the number of pump revolutions, weighing
• CPC Class Codes: A61M 1/362227 the interface providing means for actuating on functional elements of the cassette, e.g. plungers
• CPC Class Codes: A61M 1/36225 with blood pumping means or components thereof
• CPC Class Codes: A61M 1/362261 at least one cassette surface or portion thereof being flexible, e.g. the cassette having a rigid base portion with preformed channels and being covered with a foil
• CPC Class Codes: A61M 1/362265 Details of valves
• CPC Class Codes: A61M 1/362266 Means for adding solutions or substances to the blood
• CPC Class Codes: A61M 1/3633 Blood component filters, e.g. leukocyte filters
• CPC Class Codes: A61M 1/3636 having a flexible housing
• CPC Class Codes: A61M 1/3693 using separation based on different densities of components, e.g. centrifuging
• CPC Class Codes: A61M 1/3696 with means for adding or withdrawing liquid substances during the centrifugation, e.g. continuous centrifugation
• CPC Class Codes: A61M 2205/12 with interchangeable cassettes forming partially or totally the fluid circuit
• CPC Class Codes: A61M 2205/128 with incorporated valves
• CPC Class Codes: A61M 2205/331 used as turbidity change detectors, e.g. for priming-blood or plasma-hemoglubine-interface detection
• CPC Class Codes: A61M 2205/3393 by weighing the reservoir
• CPC Class Codes: A61M 60/113 : in other functional devices, e.g. dialysers or heart-lung machines
• CPC Class Codes: A61M 60/43 : using vacuum at the blood pump, e.g. to accelerate filling

Abstract

Systems and methods separate blood cells from whole blood and pump the separated blood cells through an in-line leukofilter to a blood cell storage container. The leukofilter has a filtration medium enclosed within a flexile housing. The systems and methods employ a fixture to restrain expansion of the flexible filter housing during operation of the pump. The fixture has a bracket to enable its releasable attachment to the blood processing device employed to carry out the separation process.

Claims

1. A blood processing system comprising

a blood processing set including

a donor flow channel to convey blood from a donor, a blood processing flow channel including a blood separation chamber to centrifugally separate blood cells from donor whole blood, and a blood component collection flow channel including a blood cell storage container and an in-line filter to remove leukocytes from the blood cells before entering the blood cell storage container, the in-line filter including a filter medium and a flexible housing enclosing the filter medium,

a blood processing device mounted in a case sized to enable hand transport, the blood processing device including

a pump station adapted to be placed into communication with the donor flow channel, the blood processing flow channel, and the blood component collection flow channel,

a centrifuge station adapted to support the blood separation chamber and to rotate the blood separation chamber, and

a controller to operate the pump station in multiple modes, including a processing mode, during which the pump station is operated to convey whole blood in the donor flow channel into the blood processing flow channel for separation of the blood cells in the blood separation chamber, and a collection mode, during which the pump station is operated to convey at least some of the blood cells in the blood processing flow channel into the blood component collection flow channel for on-line removal of leukocytes and collection in the blood cell storage container,

a fixture to restrain expansion of the filter housing during operation of the pump station in the collection mode, the fixture including a bracket, the case including a receptacle mating with the bracket to hold the fixture and enable releasable attachment of the fixture to the case.

4. A system according to claim 1 or 2 or 3

wherein the controller includes a function to derive a value reflecting volume of blood cells present in the blood cell storage container after passage through the filter as a percentage of volume of blood cells conveyed to the filter.

5. A system according to claim 1 or 2 or 3

wherein the pump station includes a fluid pressure actuated pump and an actuator to apply fluid pressure to the pump.

6. A system according to claim 1 or 2 or 3

wherein the blood cells comprise red blood cells.

2. A blood processing system comprising

a blood processing set including

a donor flow channel to convey blood from a donor, a blood processing flow channel including a blood separation chamber to centrifugally separate blood cells from donor whole blood, and a blood component collection flow channel including a blood cell storage container and an in-line filter to remove leukocytes from the blood cells before entering the blood cell storage container, the in-line filter including a filter medium and a flexible housing enclosing the filter medium,

a blood processing device including a base and a lid hinged to the base, the blood processing device including

a pump station adapted to be placed into communication with the donor flow channel, the blood processing flow channel, and the blood component collection flow channel,

a centrifuge station adapted to support the blood separation chamber and to rotate the blood separation chamber, and

a controller to operate the pump station in multiple modes, including a processing mode, during which the pump station is operated to convey whole blood in the donor flow channel into the blood processing flow channel for separation of the blood cells in the blood separation chamber, and a collection mode, during which the pump station is operated to convey at least some of the blood cells in the blood processing flow channel into the blood component collection flow channel for on-line removal of leukocytes and collection in the blood cell storage container,

a fixture to restrain expansion of the filter housing during operation of the pump station in the collection mode, the fixture including a bracket, the base including a holder mating with the bracket to hold the fixture and enable releasable attachment of the fixture to the base.

3. A blood processing system comprising

a blood processing set including

a donor flow channel to convey blood from a donor, a blood processing flow channel including a blood separation chamber to centrifugally separate blood cells from donor whole blood, and a blood component collection flow channel including a blood cell storage container and an in-line filter to remove leukocytes from the blood cells before entering the blood cell storage container, the in-line filter including a filter medium and a flexible housing enclosing the filter medium,

a blood processing device including a base and a lid hinged to the base, the blood processing device including

a pump station adapted to be placed into communication with the donor flow channel, the blood processing flow channel, and the blood component collection flow channel,

a centrifuge station adapted to support the blood separation chamber and to rotate the blood separation chamber, and

a controller to operate the pump station in multiple modes, including a processing mode, during which the pump station is operated to convey whole blood in the donor flow channel into the blood processing flow channel for separation of the blood cells in the blood separation chamber, and a collection mode, during which the pump station is operated to convey at least some of the blood cells in the blood processing flow channel into the blood component collection flow channel for on-line removal of leukocytes and collection in the blood cell storage container,

a fixture to restrain expansion of the filter housing during operation of the pump station in the collection mode, the fixture including a bracket, the lid including a receptacle mating with the bracket to hold the fixture and enable releasable attachment of the fixture to the lid.