Whole blood collection and processing method

• US 6,994,790 B2
• Filed: 02/03/2003
• Issued: 02/07/2006
• Est. Priority Date: 02/01/2002
• Status: Expired due to Term

• Current Assignee: Terumo BCT, Inc. (Terumo Corporation)
• Original Assignee: Gambro, Inc. (DaVita Incorporated)
• Inventors: Corbin, Frank III, Urdahl, Steven Gage
• Primary Examiner(s): DRODGE, JOSEPH W
• Application Number:
  US10/358,381
• Publication Number:
  US 20030146170A1
• Time in Patent Office: 1,100 Days
• Field of Search: 210/85, 210/90, 210/97, 210/101, 210/103, 210/110, 210/198.1, 210/199, 210/206, 210/257.1, 210/257.2, 210/326.1, 210/406, 210/416.1, 210/639, 210/645, 210/650, 210/651, 210/739, 210/741, 210/767, 604/6.01, 604/6.03, 604/6.09, 604/65, 604/67, 604/403, 604/406, 604/408, 604/410
• US Class Current: 210/639
• 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 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 single blood-collection bag that is not connected to satellite bags for receiving separated blood products, 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 before connecting said blood-collection bag to said second tube;

wherein said method does not comprise connecting another bag to the fore-mentioned components.

2. A blood collection system comprising:

a phlebotomy needle;

a first tube in fluid communication with said needle;

a first pump in pumping relation to the first tube;

a sealable container containing a blood-collection bag in fluid communication with said first tube and a vacuum pump for controlling flow into said bag and structure for controlling flow into said bag, said blood-collection bag being a single bag that is not connected to any satellite bag for receiving separated blood products;

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.

3. The system of claim 2 further comprising tubing for sterile docking said blood-collection bag to at least one further system component.

4. The system defined in claim 2 wherein each said pump is a peristaltic pump which includes a plurality of rollers.

5. The system defined in claim 2 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.

6. The system defined in claim 5 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.

7. The system of claim 6 wherein said controller is also capable of controlling the speed of the second pump.

8. The system defined in claim 2 further comprising a whole blood leukocyte removal filter in fluid communication with said first tube.

9. The system defined in claim 2 wherein said second tube connects with said first tube between said phlebotomy needle and said pressure transducer.

10. The system defined in claim 2 wherein said second tube connects with said first tube between said first pump and said blood-collection bag.

11. A method of collecting blood comprising:

activating a blood collection system of claim 2;

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

collecting whole blood into said collection bag.

12. A method for making the system of claim 2 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.

13. 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.

14. The system of claim 13 further comprising means for sterile docking said blood-collection bag to at least one further system component.

15. The system defined in claim 13 further comprising an oscillating shaker table supporting said vacuum box.

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

17. The system defined in claim 13 further comprising the blood-collection bag containing anticoagulant.

18. A method of collecting blood comprising:

activating a blood collection system of claim 13;

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

collecting whole blood into said collection bag.

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

placing said anticoagulant in said blood-collection bag.

20. A blood collection system comprising:

a phlebotomy needle;

a first tube in fluid communication with said needle;

a first pump in pumping relation to said first tube;

a blood-collection bag containing whole blood or whole blood from which only leukocytes have been removed in fluid communication with said first tube, said blood-collection bag being a single bag that is not connected to any satellite bag for receiving separated blood products;

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

a second pump in pumping relation with said second tube for pumping anticoagulant into the first tube said first and second pumps being upstream of said fluid communication of the first and second tubes.