Integrated automatic blood processing unit

• US 20060226057A1
• Filed: 04/26/2006
• Published: 10/12/2006
• Est. Priority Date: 04/19/2002
• Status: Active Grant

• Current Assignee: Terumo Medical Corporation (Terumo Corporation)
• Original Assignee: Mission Medical, Inc. (Terumo Corporation)
• Inventors: Robinson, Thomas P., Robinson, Thomas C., D'Elia, Richard, Sahines, Thomas, Eibe, Paul
• Granted Patent: US 7,531,098 B2
• Time in Patent Office: Days
• US Class Current: 210/103
• CPC Class Codes: A61M 1/0218 with filters
• 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 1/36224 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 1/362261 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 1/3633 Blood component filters, e.g. leukocyte filters
• 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: B01D 17/0217 by centrifugal force
• CPC Class Codes: B04B 5/0442 with means for adding or withdrawing liquid substances during the centrifugation, e.g. continuous centrifugation

Abstract

A system for automatically processing blood components is described. The system includes a console, which contains all motors, pumps, sensors, valves and control circuitry, and a unique disposable set that includes a cassette supporting a centrifuge with an improved design, pump interfaces with an improved design, component and solution bags, and tubing. Various processes are implemented using a specific disposable set for each process which allows automatic identification of the process to be performed the console.

Claims

1. A system for deglycerolizing red blood cells (“

RBCs”

), comprising;

a recirculation bag; and

a continuous flow centrifuge (“

CFC”

) to separate a waste product from fluid containing RBCs, said CFC in fluid communication with said recirculation bag by a first tubing segment, said first tubing segment terminating at its first end at said CFC, and terminating at its second end at said recirculation bag;

a blood pump to pump fluid containing RBCs from said recirculation bag to said CFC, said blood pump configured on said first tubing segment;

a first valve to control the flow of fluid into said recirculation bag, said first valve configured on a second tubing segment, said second tubing segment terminating at its first end at said CFC, and terminating at its second end at said recirculation bag;

a deglycerolized RBC bag to contain deglycerolized RBCs, said deglycerolized RBC bag in fluid communication with said second tubing segment by a third tubing segment, said third tubing segment terminating at its first end at said deglycerolized RBC bag, and terminating at its second end at a first junction with said second tubing segment, said first junction configured on said second tubing segment between said CFC and said first valve;

a second valve to control the flow of fluid into said deglycerolized RBC bag, said second valve configured on said third tubing segment; and

a cassette through which said first, second and third tubing segments pass.

2. The system of claim 1, further comprising an optical sensor to detect a position of an interface within said CFC.

3. The system of claim 1, further comprising a recirculation bag shaker to shake said recirculation bag, and wherein said recirculation bag further includes a blood filter to eliminate particulates, clots and white cell agglomerates that form during operation of said system.

4. The system of claim 1, further comprising a free plasma hemoglobin sensor to detect hemoglobin in said waste product.

5. The system of claim 1, further comprising a console that houses said cassette.

6. The system of claim 1, further comprising:

a RBC pump to pump fluid from which waste product has been removed by said CFC from said CFC, said RBC pump configured on said second tubing segment between said CFC and said first junction;

a third valve to control the flow of fluid from said CFC, said third valve configured on said second tubing segment between said CFC and said RBC pump;

a waste product bag to contain waste product separated with said CFC, said waste product bag in fluid communication with said CFC by a fourth tubing segment, said fourth tubing segment terminating at its first end at said waste product bag, and terminating at its second end at said CFC; and

a fourth valve to control the flow of fluid to said waste product bag, said fourth valve configured on said fourth tubing segment between said CFC and said waste product bag.

7. The system of claim 6, further comprising:

a first pressure measurement device to detect the flow of fluid from said blood pump to said CFC through said first tubing segment, said first pressure measurement device configured along said first tubing segment between said RBC pump and said CFC;

a second pressure measurement device to detect the flow of fluid from which waste product has been removed by said CFC through said second tubing segment, said second pressure measurement device configured along said second tubing segment between said CFC and said RBC pump;

a third pressure measurement device to detect the flow of fluid from said RBC pump through said second tubing segment, said third pressure measurement device configured along said second tubing segment between said RBC pump and said first junction; and

a first ultrasonic sensor to detect air in said first tubing segment, said first ultrasonic sensor configured along said first tubing segment between said recirculation pump and said blood pump.

8. The system of claim 1, further comprising:

a glycerolized RBC bag to contain glycerolized RBCs, said glycerolized RBC bag in fluid communication with said second tubing segment by a fifth tubing segment, said fifth tubing segment terminating at its first end at said glycerolized RBC bag, and terminating at its second end at said first junction with said second tubing segment, wherein said glycerolized RBC bag is attached to said fifth tubing segment by a sterile dock;

a thawed RBC pump to pump glycerolized RBCs from said glycerolized RBC bag, said thawed RBC pump configured on said fifth tubing segment between said glycerolized RBC bag and said first junction;

a second ultrasonic sensor to detect air in said fifth tubing segment, said second ultrasonic sensor configured along said fifth tubing segment between said glycerolized RBC bag and said thawed RBC pump;

a static mixer to combine said glycerolized RBCs with a solution, said static mixer configured on said fifth tubing segment between said thawed RBC pump and said first junction; and

a fifth valve to control the flow of fluid from said static mixer, said fifth valve configured on said fifth tubing segment between said static mixer and said first junction.

9. The system of claim 8, further comprising:

a first solution bag to contain a first solution, said first solution bag connected with a spike to a first end of a first solution tubing segment, and said first solution tubing segment terminating at its second end to a solution junction on a sixth tubing segment;

a first solution valve to control the flow of said first solution from said first solution bag, said first solution valve configured on said first solution tubing segment;

a second solution bag to contain a second solution, said second solution bag connected with a spike to a first end of a second solution tubing segment, and said second solution tubing segment terminating at its second end to a first solution tubing segment junction on said first solution tubing segment, said first solution tubing segment junction configured on said first solution tubing segment between said first solution valve and said solution junction;

a second solution valve to control the flow of said second solution from said second solution bag, said second solution valve configured on said second solution tubing segment;

a third solution bag to contain a third solution, said third solution bag connected with a spike to a first end of said sixth tubing segment, said sixth tubing segment terminating at its second end at a second junction configured on said fifth tubing segment between said thawed RBC pump and said static mixer;

a third solution valve to control the flow of said third solution from said third solution bag, said third solution valve configured on said sixth tubing segment between said third solution bag and said solution junction;

a solution pump to pump a solution from a solution bag, said solution pump configured on said sixth tubing segment between said solution junction and said second junction;

a third ultrasonic sensor to detect air in said sixth tubing segment, said third ultrasonic sensor configured along said sixth tubing segment between said solution junction and said solution pump;

a first bacterial filter to maintain sterility of said system, said first bacterial filter configured on said sixth tubing segment between said solution pump and said second junction;

a second bacterial filter to maintain sterility of said system, said second bacterial filter configured on a seventh tubing segment, said seventh tubing segment terminating at its first end at a third junction on said sixth tubing segment between said solution pump and said first bacterial filter, and terminating at its second end at a fourth junction on said second tubing segment between said CFC and said first junction; and

a solution pressure measurement device to detect the flow of a solution from said solution pump through said seventh tubing segment, said solution pressure measurement device configured along said seventh tubing segment between said third junction and said second bacterial filter.

10. The system of claim 9, wherein said first solution is a hypertonic solution, said second solution is an isotonic solution, and said third solution is a wash solution.

11. The system of claim 9, further comprising:

a sixth valve to control the flow of a solution through said seventh tubing segment, said sixth valve configured on said seventh tubing segment between said second bacterial filter and said fourth junction;

a seventh valve to control the flow of fluid from which waste product has been removed by said CFC through said second tubing segment, said seventh valve configured on said second tubing segment between said second CFC and said fourth junction;

a fourth pressure measurement device to detect the flow of fluid from said blood pump to said CFC through said first tubing segment, said fourth pressure measurement device configured along said first tubing segment between said RBC pump and said CFC;

a fifth pressure measurement device to detect the flow of fluid from which waste product has been removed by said CFC through said second tubing segment, said second pressure measurement device configured along said second tubing segment between said CFC and said fourth junction;

a sixth pressure measurement device to detect the flow of fluid through said second tubing segment, said sixth pressure measurement device configured along said second tubing segment between said first junction and said fourth junction;

a third ultrasonic sensor to detect air in said first tubing segment, said third ultrasonic sensor configured along said first tubing segment between said recirculation pump and said blood pump; and

a waste product bag to contain waste product separated with said CFC, said waste product bag in fluid communication with said CFC by a waste product tubing segment, said waste product tubing segment terminating at its first end at said waste product bag, and terminating at its second end at said CFC; and

a waste pump to pump a waste product from said CFC, said waste pump configured on said waste product tubing segment between said CFC and said waste product bag.

12. The system of claim 1, further comprising:

a first solution bag to contain a first solution, said first solution bag connected with a spike to a first end of a first solution tubing segment, and said first solution tubing segment terminating at its second end to a solution junction on an eighth tubing segment;

a first solution pump to pump said first solution from said first solution bag, said first solution pump configured on said first solution tubing segment;

a second solution bag to contain a second solution, said second solution bag connected with a spike to a first end of said eighth tubing segment, said eighth tubing segment terminating at its second end at either said first junction or a fifth junction with said second tubing segment, said fifth junction configured between said CFC and said first junction;

a second solution pump to pump a solution from a solution bag, said second solution pump configured on said eighth solution tubing segment between said second solution bag and said solution junction;

a bacterial filter to maintain sterility of said system, said bacterial filter configured on said eighth tubing segment between said solution junction and said and said eighth tubing segment junction;

a fourth ultrasonic sensor to detect air in said first solution tubing segment, said fourth ultrasonic sensor configured along said first solution tubing segment between said first solution bag and said first solution pump;

a fifth ultrasonic sensor to detect air in said eighth tubing segment, said fifth ultrasonic sensor configured along said eighth solution tubing segment between said second solution bag and said second solution pump; and

a solution pressure measurement device to detect the flow of a solution through said eighth tubing segment, said solution pressure measurement device configured along said eighth tubing segment between said solution junction and said bacterial filter.

13. The system of claim 12, wherein said eighth tubing segment terminates at its second end at said fifth junction, said system further comprising:

a glycerolized RBC bag to contain glycerolized RBCs, said glycerolized RBC bag in fluid communication with said eighth tubing segment by a glycerolized tubing segment, said glycerolized tubing segment terminating at its first end at said glycerolized RBC bag, and terminating at its second end at a glycerolized junction with said eighth tubing segment between said fifth junction and said bacterial filter, wherein said glycerolized RBC bag is attached to said glycerolized tubing segment by a sterile dock;

a glycerolized valve to control the flow of glycerolized RBCs from said glycerolized RBC bag, said glycerolized valve configured on said glycerolized tubing segment;

a sixth ultrasonic sensor to detect air in said glycerolized tubing segment, said sixth ultrasonic sensor configured along said glycerolized tubing segment between said glycerolized valve and said glycerolized junction; and

a static mixer to combine said glycerolized RBCs with a solution, said static mixer configured on said eighth tubing segment between said glycerolized junction and said fifth junction.

14. The system of claim 13, further comprising:

a third solution bag to contain a third solution, said third solution bag connected with a spike to a first end of a third solution tubing segment, said third solution tubing segment terminating at its second end at a third solution junction on said eighth tubing segment, said third solution junction configured on said eighth tubing segment between said second solution bag and said fifth ultrasonic sensor;

a third solution valve to control the flow of said third solution from said third solution bag, said third solution valve configured on said third solution tubing segment; and

a second solution valve to control the flow of said second solution from said second solution bag, said second solution valve configured on said eighth tubing segment between said second solution bag and said third solution junction.

15. The system of claim 12, wherein said eighth tubing segment terminates at its second end at said fifth junction, said system further comprising:

a glycerolized RBC bag to contain glycerolized RBCs, said glycerolized RBC bag in fluid communication with said first tubing segment by a glycerolized tubing segment, said glycerolized tubing segment terminating at its first end at said glycerolized RBC bag, and terminating at its second end at a glycerolized junction with said first tubing segment between said blood pump and said CFC, wherein said glycerolized RBC bag is attached to said glycerolized tubing segment by a sterile dock;

a glycerolized valve to control the flow of glycerolized RBCs from said glycerolized RBC bag, said glycerolized valve configured on said glycerolized tubing segment;

an eighth valve to control the flow of fluid into said CFC, said eighth valve configured on said first tubing segment between said glycerolized junction and said CFC;

an ninth valve to control the flow of fluid from said CFC, said ninth valve configured on said second tubing segment between said CFC and said fifth junction;

a seventh pressure measurement device to detect the flow of fluid into said CFC through said first tubing segment, said seventh pressure measurement device configured along said first tubing segment between said glycerolized junction and said CFC;

an eighth pressure measurement device to detect the flow of fluid from which waste product has been removed by said CFC through said second tubing segment, said eighth pressure measurement device configured along said second tubing segment between said CFC and said fifth junction;

a waste product bag to contain waste product separated with said CFC, said waste product bag in fluid communication with said CFC by a waste product tubing segment, said waste product tubing segment terminating at its first end at said waste product bag, and terminating at its second end at said CFC;

a waste pump to pump a waste product from said CFC, said waste pump configured on said waste product tubing segment between said CFC and said waste product bag; and

a ninth pressure measurement device to detect the flow of waste product from said waste pump through said waste product tubing segment, said ninth pressure measurement device configured along said waste product tubing segment between said waste product pump and said waste product bag.

16. The system of claim 1, further comprising:

a glycerolized RBC bag to contain glycerolized RBCs, said glycerolized RBC bag in fluid communication with said recirculation bag with a glycerolized tubing segment, said glycerolized tubing segment terminating at its first end at said glycerolized RBC bag, and terminating at its second end at said recirculation bag, wherein said glycerolized RBC bag is attached to said glycerolized tubing segment by a sterile dock;

a glycerolized valve to control the flow of glycerolized RBCs from said glycerolized RBC bag to said recirculation bag, said glycerolized valve configured on said glycerolized tubing segment;

a glycerolized ultrasonic sensor to detect air in said glycerolized tubing segment, said glycerolized ultrasonic sensor configured along said glycerolized tubing segment between said glycerolized valve and said glycerolized RBC bag; and

a RBC pump to pump fluid from which waste product has been removed by said CFC from said CFC, said RBC pump configured on said second tubing segment between said CFC and said first junction.

17. A method of deglycerolizing red blood cells (“

RBCs”

), comprising;

providing a RBC deglycerolizing system, including

a continuous flow centrifuge (“

CFC”

) adapted to separate deglycerolized RBCs from a waste product,

a glycerolized RBC bag containing thawed, glycerolized RBCs,

at least two solution bags containing at least one solution,

a recirculation bag, said recirculation bag in fluid communication with said glycerolized RBC bag, said at least two solution bags, said CFC and a deglycerolized RBC bag by way of tubing, and

a cassette through which said tubing passes;

configuring said concentrating system with a console including electronic and mechanical components to operate said concentrating system; and

operating said deglycerolizing system to deglycerolize RBCs.