Whole blood collection and processing method

• US 20030146170A1
• Filed: 02/03/2003
• Published: 08/07/2003
• Est. Priority Date: 02/01/2002
• Status: Active Grant

• Current Assignee: Terumo BCT, Inc. (Terumo Corporation)
• Original Assignee: Gambro, Inc. (DaVita Incorporated)
• Inventors: Corbin, Frank III, Urdahl, Steven Gage
• Granted Patent: US 6,994,790 B2
• Time in Patent Office: Days
• US Class Current: 210/739
• 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 1/3633 Blood component filters, e.g. leukocyte filters
• CPC Class Codes: A61M 1/387 taking into account of the needs or inventory
• CPC Class Codes: A61M 2202/0439 White blood cells; Leucocytes

Abstract

A method is disclosed for collecting and processing whole blood. Whole blood is collected at several remote donor sites and transported to a central blood-processing center, where information regarding demand for blood products is used to direct processing of whole blood into blood products. Whole blood is initially collected in collection bags unattached to satellite bags instead of commonly used multiple bag sets. When the determination is made at the blood processing center as to which blood products are to be made, the appropriate satellite bags and/or other system components are sterile docked to the blood-collection bag and the whole blood is processed. The use of blood-collection bags initially unattached to satellite bags eliminates waste and simplifies the transportation and processing of whole blood. Also disclosed are blood collection systems that remove leukocytes and collect whole blood into blood-collection bags unattached to satellite bags.

Claims

1. A method for manufacturing blood products from whole blood comprising the steps:

collecting whole blood, in blood-collection bags, from a plurality of donors, at one or more blood-collection sites, wherein said blood is collected by one or more technicians, and no determination is made at said one or more blood-collection sites as to what blood products are to be manufactured from said blood;

marking said blood-collection bags with identifying information;

transporting filled blood-collection bags from said one or more blood-collection sites to a manufacturing site;

compiling information regarding current demand for separate blood products that can be manufactured from the blood in said collection bags;

determining at said manufacturing site, using said information regarding current demand, what blood components are to be separated from blood in said blood-collection bags;

sterile docking said blood collection bags to blood-processing bags or appropriate satellite bags to contain said blood components to be separated; and

separating said required blood products from said blood.

2. The method of claim 1 wherein said blood-collection bag is a single bag not connected to other bags.

3. The method of claim 1 wherein said separation step comprises transferring blood from said blood-collection bags to blood-processing bags prior to separation of said blood products.

4. The method of claim 3 wherein said separation step comprises:

centrifuging said whole blood in a blood-processing bag to separate said blood into blood components; and

sterile-docking said blood-processing bag to a number of blood-product bags corresponding to the number of blood products it has been determined to manufacture from blood in said blood-collection bag, said sterile docking to occur prior to said centrifuging step or immediately after said centrifuging step.

5. The method of claim 2 wherein said separation step comprises:

centrifuging said whole blood in a blood-collection bag to separate said blood into blood components; and

thereafter

sterile-docking said blood-collection bag to a number of blood-product bags corresponding to the number of blood products it has been determined to manufacture from blood in said blood-collection bag.

6. The method of claim 1 wherein said separation step comprises removing leukocytes from said whole blood prior to separation of other compartments.

7. The method of claim 4 wherein said blood components are pumped into said blood-product bags.

8. The method of claim 4 wherein said blood components are expressed into said blood-product bags.

9. The method of claim 5 wherein said blood components are pumped into said blood-product bags.

10. The method of claim 5 wherein said blood components are expressed into said blood-product bags.

11. A blood collection system comprising:

a phlebotomy needle;

a first tube in fluid communication with said needle;

a whole blood leukocyte removal filter having an inlet in fluid communication with said first tube;

a second tube in fluid communication with an outlet of said filter; and

a blood-collection bag in fluid communication with said second tube, said blood collection bag being a single bag that is not connected to other bags.

12. The system of claim 11 further comprising tubing for sterile docking said blood-collection bag to at least one further system component.

13. The system of claim 11 further comprising an anticoagulant bag containing anticoagulant in fluid communication with either said first tube or said second tube.

14. The system of claim 11 wherein the blood-collection bag contains anticoagulant.

15. A method for making a blood collecting system comprising:

providing a phlebotomy needle, first and second tubes, a leukocyte removal filter having an inlet and an outlet, a blood-collection bag that is not connected to other bags, and anticoagulant;

connecting said needle to an end of said first tube;

connecting another end of said first tube to the inlet of said filter;

connecting the outlet of said filter to an end of the second tube;

connecting another end of the second tube to said blood collection bag; and

placing said anticoagulant in said blood collection bag.

16. A blood collection system comprising:

a phlebotomy needle;

a first tube in fluid communication with said needle;

a first pump in pumping relation to first tube;

a blood-collection bag in fluid communication with said first tube, said blood collection bag being a single bag that is not connected to other bags;

an anticoagulant bag containing anticoagulant in fluid connection with a second tube, said second tube being in fluid communication with said first tube; and

a second pump in pumping relation with said second tube for pumping anticoagulant into the first tube.

17. The system of claim 16 further comprising tubing for sterile docking said blood-collection bag to at least one further system component.

18. The system defined in claim 16 wherein each said pump is a peristaltic pump which includes a plurality of rollers.

19. The system defined in claim 16 further including a pressure transducer positioned between said phlebotomy needle and said first pump, said transducer producing an output signal corresponding to the pressure within said first tube.

20. The system defined in claim 19 further comprising a controller capable of receiving the output signal from said pressure transducer and adjusting the speed of said first pump in response to said output signal.

21. The system of claim 20 wherein said controller is also capable of controlling the speed of the second pump.

22. The system defined in claim 16 further comprising a whole blood leukocyte removal filter in fluid communication with said first tube.

23. The system defined in claim16 wherein said second tube connects with said first tube between said phlebotomy needle and said pressure transducer.

24. The system defined in claim 16 wherein said second tube connects with said first tube between said first pump and said blood-collection bag.

25. A method of collecting blood comprising:

activating a blood collection system of claim 16;

inserting said phlebotomy needle into a patient'"'"'s blood vessel; and

collecting whole blood into said collection bag.

26. A method for making the system of claim 16 comprising:

providing a phlebotomy needle, first and second tubes, a blood-collection bag that is not connected to other bags, first and second pumps, and an anticoagulant bag;

connecting said needle to an end of said first tube;

connecting said anticoagulant bag to an end of said second tube;

connecting another end of the second tube to the first tube;

connecting another end of the first tube to said blood collection bag;

placing said first pump in pumping relation to said first tube; and

placing said second pump in pumping relation to second tube.

27. A blood collection system comprising:

a phlebotomy needle;

a first tube in fluid communication with said needle;

a whole blood leukocyte removal filter having an inlet in fluid communication with first tube;

a second tube in fluid communication with an outlet of said filter;

a blood-collection bag in fluid communication with said second tube, said blood collection bag being a single bag that is not connected to other bags;

a sealable vacuum box comprising a vacuum pump for evacuating said vacuum box, wherein said blood-collection bag is sealed within said vacuum box and the flow rate of blood into said blood-collection bag is controlled by adjusting the vacuum; and

a scale able to weigh said blood-collection bag while said blood-collection bag is sealed inside said vacuum box.

28. The system of claim 27 further comprising means for sterile docking said blood-collection bag to at least one further system component.

29. The system defined in claim 27 further comprising an oscillating shaker table supporting said vacuum box.

30. The system defined in claim 27 further comprising an anticoagulant bag containing anticoagulant in fluid communication with either said first tube or said second tube.

31. The system defined in claim 27 further comprising the blood-collection bag containing anticoagulant.

32. A method of collecting blood comprising:

activating a blood collection system of claim 27;

inserting said phlebotomy needle into a patient'"'"'s blood vessel; and

collecting whole blood into said collection bag.

33. A method for making a blood collecting system comprising:

providing a phlebotomy needle, a first and second tube, a leukocyte removal filter, a blood-collection bag that is not connected to other bags, a vacuum box comprising a vacuum pump for evacuating said vacuum box, a scale, and anticoagulant;

connecting said needle to an end of said first tube;

connecting another end of said tube to the inlet of said filter;

connecting the outlet of said filter to an end of the second tube;

connecting another end of the second tube to said blood collection bag;

placing said blood-collection bag inside said vacuum box, sealing said vacuum box, and evacuating said vacuum box placing said blood-collection bag on top of said scale; and

placing said anticoagulant in said blood-collection bag.

34. A blood component transferal system comprising:

a blood-component bag containing blood, wherein said blood has been centrifuged such that blood components in said bag are located in separate, layered regions of said bag;

a tube in fluid communication with said blood-component bag, wherein one end of said tube is connected with said bag and the other end of said tube splits into at least two branches;

at least two blood-product bags in fluid communication with said tube, wherein each blood-product bag is connected to one of said branches;

an optical controller comprising an optical sensor positioned upstream from said branches, wherein said optical sensor causes said controller to produce an output signal responsive to light received from fluid flowing through said tube;

clamps on at least one of said branches, capable of opening and closing in response to the signal from said optical controller.

35. The system defined in claim 34 also comprising a pump in pumping relation with said tube.

36. The system defined in claim 34 also comprising an expresser in pressing relation to said blood-component bag.

37. The system defined in claim 34 further including a leukocyte removal filter in fluid communication with said tube.