Extracorporeal blood processing methods and apparatus

• US 5,702,357 A
• Filed: 06/07/1995
• Issued: 12/30/1997
• Est. Priority Date: 06/07/1995
• Status: Expired due to Term

• Current Assignee: Terumo BCT, Inc. (Terumo Corporation)
• Original Assignee: COBE Laboratories Incorporated (Terumo Corporation)
• Inventors: Holmes, Brian M., Bainbridge, Marlene Adele
• Primary Examiner(s): Weiss, John G.
• Assistant Examiner(s): O YONG, KI
• Application Number:
  US08/480,617
• Time in Patent Office: 937 Days
• Field of Search: 494/43, 494/45, 494/46, 494/47, 494/56, 494/60, 604/4-6
• US Class Current: 604/4.01
• 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 1/303 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 1/36222 Details related to the interface between cassette and machine
• CPC Class Codes: A61M 1/36224 with sensing means or components thereof
• CPC Class Codes: A61M 1/36225 with blood pumping means or components thereof
• CPC Class Codes: A61M 1/36226 Constructional details of cassettes, e.g. specific details on material or shape
• CPC Class Codes: A61M 1/362262 Details of incorporated reservoirs
• 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 1/3624 Level detectors; Level control
• CPC Class Codes: A61M 1/3639 Blood pressure control, pressure transducers specially adapted therefor
• CPC Class Codes: A61M 1/3641 Pressure isolators
• CPC Class Codes: A61M 1/3652 using gas, e.g. air
• CPC Class Codes: A61M 1/3692 Washing or rinsing blood or blood constituents
• 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 2205/123 with incorporated reservoirs
• CPC Class Codes: A61M 2205/125 with incorporated filters
• CPC Class Codes: A61M 2205/128 : with incorporated valves
• CPC Class Codes: A61M 2205/14 : Detection of the presence or absence of a tube, a connector or a container in an apparatus
• CPC Class Codes: A61M 2205/3382 : Upper level detectors
• CPC Class Codes: A61M 2205/3386 : Low level detectors
• CPC Class Codes: A61M 2205/505 : Touch-screens; Virtual keyboard or keypads; Virtual buttons; Soft keys; Mouse touches
• CPC Class Codes: B04B 2005/045 : having annular separation channels
• CPC Class Codes: B04B 5/0442 : with means for adding or withdrawing liquid substances during the centrifugation, e.g. continuous centrifugation
• CPC Class Codes: B04B 9/08 : Arrangement or disposition of transmission gearing for solid bowl screw centrifuges B04B1/2016; Couplings; Brakes

Abstract

An extracorpeal blood processing system is disclosed which includes a variety of novel components and which may be operated in accordance with a variety of novel methodologies. For instance, the system includes a graphical operator interface which directs the operator through various aspects of the apheresis procedure. Moreover, the system also includes a variety of features relating to loading a blood processing vessel into a blood processing channel and removing the same after completion of the procedure. Furthermore, the system also includes a variety of features relating to utilizing a blood priming of at least portions of the apheresis system in preparation for the procedure. In addition, the system includes a variety of features enhancing the performance of the apheresis system, including the interrelationship between the blood processing vessel and the blood processing vessel and the utilization of high packing factors for the procedure.

Claims

1. A blood primable blood processing channel assembly for an apheresis system comprising a centrifuge rotor, said channel assembly comprising:

a channel housing interconnectable with said centrifuge rotor and comprising a blood processing channel, said channel comprising a first cell separation stage and wherein a remainder of said channel comprises at least one other stage, said channel further comprising a blood inlet and a red blood cell outlet fluidly interconnected with said first cell separation stage, wherein blood provided to said channel through said blood inlet has a first hematocrit and a fluid containing red blood cells removed from said channel through said red blood cell outlet has a second hematocrit, wherein a ratio of a volume of said remainder of said channel to a volume of said first cell separation stage is less than one-half of one less than a ratio of the second hematocrit to the first hematocrit.

2. A channel assembly, as claimed in claim 1, wherein:

said channel extends curvilinearly about a rotational axis of said channel housing, said channel further comprising a red blood cell dam, a platelet collection area, a plasma collection area, and an interface control region for controlling a radial position of at least one interface between red blood cells and an adjacent blood component type, wherein said red blood cell dam is disposed between said first cell separation stage and said platelet collection area, wherein said platelet collection area is disposed between said red blood cell dam and said plasma collection area, and wherein said plasma collection area is disposed between said platelet collection area and said interface control region, wherein blood introduced into said channel is separated into layers of red blood cells, white blood cells, platelets, and plasma in said first cell separation stage, and wherein at least one flow through said channel is from said first cell separation stage, then past said red blood cell dam, then into said platelet collection area, then into said plasma collection area, and then into said interface control region.

3. A channel assembly, as claimed in claim 2, wherein:

said channel further comprises means for providing said plasma to said interface control region before any of said red blood cells flow beyond said red blood cell dam and into said platelet collection area.

4. A channel assembly, as claimed in claim 2, wherein:

said channel further comprises means for providing at least one of said blood, said red blood cells, said white blood cells, said platelets, and said plasma throughout an entirety of said channel before any of said red blood cells flow beyond said red blood cell dam toward said platelet collection area.

5. A channel assembly, as claimed in claim 2, wherein:

a reference circle having an origin at said rotational axis intersects on said red blood cell dam at a predetermined position, and wherein a ratio of a volume of said channel disposed inside of said reference circle to a volume of said channel disposed outside of said reference circle is no greater than about 0.25.

6. A channel assembly, as claimed in claim 1, wherein:

when said first hematocrit is about 0.47 and said second hematocrit is about 0.75, said ratio of said volume of said remainder of said channel to said volume of said first cell separation stage is about 0.3.

7. A channel assembly, as claimed in claim 2, wherein:

a width of said channel between said platelet collection area and said plasma collection area is less than a width of said channel throughout said first cell separation stage.

8. A channel assembly, as claimed in claim 7, wherein:

said width of said channel between said platelet collection area and said plasma collection area is substantially constant.

9. A channel assembly, as claimed in claim 2, wherein:

said channel further comprises a blood inlet region proximate said first cell separation stage, wherein a first reference ray extends from said rotational axis through said blood inlet region and a second reference ray extends from said rotational axis and through said interface control region, wherein at least part of a flow to said interface control region is from said plasma collection area and wherein said first and second rays are separated by a first radial distance relative to said rotational axis, said first radial distance being greater than about 330°

.

10. A channel assembly, as claimed in claim 2, wherein:

said channel further comprises means for limiting a flow into said interface control region from said first cell separation stage, to said red blood cells.

11. A channel assembly, as claimed in claim 2, wherein:

an angular extent of said channel about said rotational axis is greater than about 360° and

less than about 390°

.

12. A channel assembly, as claimed in claim 1, further comprising:

a blood processing vessel disposed in said channel;

means for displacing air from said blood processing vessel; and

means for priming said blood processing vessel with blood.

13. A system, as claimed in claim 12, wherein:

said means for priming comprises a configuration of said blood processing channel which provides said ratio of a volume of said remainder of said channel to a volume of said first cell separation stage.

14. A system, as claimed in claim 12, further comprising:

a donor/patient blood transfer assembly fluidly interconnected with said blood processing vessel, fluidly interconnectable with a donor/patient, and comprising an air receptacle, wherein said means for displacing displaces air within said blood processing vessel into said air receptacle.