Extracorporeal blood processing methods

• US 5,837,150 A
• Filed: 06/07/1995
• Issued: 11/17/1998
• Est. Priority Date: 06/07/1995
• Status: Expired due to Term

• Current Assignee: Terumo BCT, Inc. (Terumo Corporation)
• Original Assignee: Cobe Cardiovascular Incorporated (LivaNova Plc)
• Inventors: Holmes, Brian M., Langley, Robert W., Bainbridge, Marlene Adele
• Primary Examiner(s): Kim, John
• Application Number:
  US08/484,209
• Time in Patent Office: 1,259 Days
• Field of Search: 210/781, 210/782, 210/787, 210/789, 210/739, 494/7, 494/9, 494/10, 494/37, 494/75, 604/4, 604/5, 604/6
• US Class Current: 210/782
• 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 1/36226 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 1/362264 the filter being a blood filter
• 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 2205/123 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 2205/505 Touch-screens; Virtual keyboard or keypads; Virtual buttons; Soft keys; Mouse touches
• 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

A method for processing blood in an apheresis system is disclosed. The present invention includes selecting a packing factor for separated blood component types in the separation stage(s) of a blood processing vessel. A packing factor is a number that reflects the degree with which the blood component types are packed together in the separation stage(s) and is dependent at least upon the rotational speed and the flow rate into the blood processing vessel. The method further includes providing an apheresis system and operating it under conditions to separate the blood into a plurality of blood component types and achieve the selected packing factor.

Claims

1. A method for processing blood in an apheresis system, comprising the steps of:

selecting a blood component packing factor range from about 11 to about 15, wherein said packing factor is equal to the square of a channel housing rotational speed, multiplied by an average distance from a rotational axis of a channel housing to an outer wall of a channel, multiplied by a sedimentation velocity of red blood cells at 1 G, multiplied by a volume of a channel, divided by the width of a channel, and divided by a blood flow rate to a blood processing vessel within a channel;

providing an apheresis system comprising a channel housing having a first stage of a blood processing channel with an outer wall, a width and a volume, a blood processing vessel positioned within said channel, and a rotational axis; and

rotating said channel housing at a first rotational speed, and providing a flow comprising blood to said blood processing vessel at a first flow rate to separate said blood into a plurality of blood components, such that the packing factor produced by (i) said rotational speed, (ii) an average distance from said rotational axis to said outer wall of said channel, (iii) said channel volume, (iv) said channel width, and (v) said flow rate;

is within said selected packing factor range.

2. A method, as claimed in claim 1, said method further comprising the steps of:

achieving said blood component packing factor range of blood components within said blood processing vessel for said first rotational speed, said first flow rate and during said rotating step;

changing said first flow rate to a second flow rate; and

changing said first rotational speed to a second rotational speed to substantially maintain said blood component packing factor range.

3. A method, as claimed in claim 2, wherein:

said second flow rate is greater than said first flow rate, and wherein said changing said first rotational speed to a second rotational speed step comprises said second rotational speed being greater than said first rotational speed.

4. A method, as claimed in claim 1, wherein:

said blood component packing factor range is about 13 for a magnitude of said flow rate up to about 55 milliliters per minute.

5. A method, as claimed in claim 1, further comprising the step of:

removing at least one of said plurality of blood components from said blood processing vessel.

6. A method, as claimed in claim 1, wherein:

said channel housing has an outer diameter of about 10 inches, and wherein during at least a portion of said rotating step said blood is exposed to a centrifugal force of at least about 800 Gs.

7. A method, as claimed in claim 6 wherein:

said centrifugal force is about 1,100 Gs.

8. A method for processing blood in an apheresis system comprising a blood processing vessel and a channel housing having a diameter of no greater than about ten inches and comprising a blood processing channel, said blood processing vessel being positioned in said channel, said method comprising the steps of:

selecting a packing factor of blood components in a first stage of said channel of at least 10, wherein said packing factor is a dimensionless quantification of the degree of packing of the blood components in said first stage;

rotating said channel housing and providing a flow to said blood processing vessel at a rate ranging from about 40 milliliters per minute to about 70 milliliters per minute, said flow comprising blood to separate said blood into a plurality of blood components in said first stage of said channel at said packing factor of blood components; and

removing at least one of said plurality of blood components from said blood processing vessel.

9. A method, as claimed in claim 8, wherein:

said rotating step comprises rotating said channel housing at a rotational velocity greater than about 2,500 RPM.

10. A method, as claimed in claim 8, wherein:

said rotating step comprises rotating said channel housing at a rotational velocity of about 3,000 RPM.

11. A method, as claimed in claim 8, wherein:

said rotating step further comprises maintaining a packing factor of blood components in said first stage of said channel of at least 10.2.

12. A method, as claimed in claim 8, wherein:

said rotating step further comprises the steps of directing said blood into said first stage, impeding a flow of red blood cells in a first direction beyond a red blood cell dam disposed at an end of said first stage, allowing platelets to flow in said first direction beyond said red blood cell dam, and reducing a sedimentation distance in said first stage progressing toward said red blood cell dam.