Methods for separating, collecting and storing red blood cells

• US 6,527,957 B1
• Filed: 04/07/1999
• Issued: 03/04/2003
• Est. Priority Date: 08/09/1995
• Status: Expired due to Term

• Current Assignee: Fenwal Incorporated (Fresenius SE & Co. KGaA)
• Original Assignee: Baxter International Inc.
• Inventors: Duff, Daniel H., Buchholz, Donald H., Deniega, Jose C., Gudino, Maria D.
• Primary Examiner(s): KIM, SUN U
• Application Number:
  US09/287,671
• Time in Patent Office: 1,427 Days
• Field of Search: 210/85, 210/86, 210/90, 210/109, 210/134, 210/143, 210/782, 210/787, 210/789, 210/739, 210/767, 210/806, 210/651, 210/650, 210/321, 210/67, 435/2, 494/37, 604/4, 604/5, 604/6, 604/65, 604/67, 604/4.01, 604/5.01, 604/6.01, 604/6.02, 604/6.07
• US Class Current: 210/651
• CPC Class Codes: A01N 1/02 Preservation of living parts
• CPC Class Codes: A01N 1/0226 Physiologically active agents, i.e. substances affecting physiological processes of cells and tissue to be preserved, e.g. anti-oxidants or nutrients
• CPC Class Codes: A01N 1/0242 Apparatuses, i.e. devices used in the process of preservation of living parts, such as pumps, refrigeration devices or any other devices featuring moving parts and/or temperature controlling components
• CPC Class Codes: A61M 1/265 inducing Taylor vortices
• 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 1/306 Pressure control, e.g. using substantially rigid closed or gas buffered or elastic reservoirs
• 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 1/309 with trans-membrane pressure [TMP] increasing substantially continuously during arterial phase
• CPC Class Codes: A61M 2205/3393 by weighing the reservoir
• CPC Class Codes: A61M 2209/082 Mounting brackets, arm supports for equipment

Abstract

Methods are disclosed for the collection of red blood cells whereby whole blood is combined with an anticoagulant, red cells are separated from the whole blood and the separated red cells are combined with a storage solution. The red cells may be stored for an extended period of time.

Claims

1. A method for providing viable red blood cells comprising:

a) providing a quantity of whole blood;

b) combining said whole blood with a selected quantity of a phosphate-free anticoagulant, wherein one liter of said anitcoagulant comprises approximately 7.3 g of citric acid, 22.0 g of trisodium citrate and 24.5 g of dextrose;

c) separating said anticoagulated whole blood into components to provide concentrated red blood cells;

d) combining said concentrated red blood cells with a solution, wherein one liter of said solution comprises approximately 22.0 g dextrose, 0.27 g adenine, 7.5 g mannitol and 9.0 g sodium chloride.

2. The method of claim 1 further comprising:

a) providing a separation device;

b) establishing fluid communication between a donor and said blood separation device;

c) removing whole blood from a donor to provide said quantity of whole blood;

d) introducing said anticoagulated whole blood into said separation device; and

e) separating said anticoagulated whole blood into components wherein one of the components comprises concentrated red blood cells while maintaining fluid communication between said donor and said blood separation device.

3. The method of claim 1 further comprising collecting at least a portion of said concentrated red blood cells in a container.

4. The method of claim 2 wherein said separation device comprises a membrane filtration device.

5. The method of claim 1 comprising passing said red blood cells through a filter for removing white blood cells.

6. The method of claim 3 further comprising sensing changes in the weight of said container as said concentrated red blood cells are collected in said container.

7. The method of claim 2 comprising returning at least a portion of said concentrated red blood cells to said donor.

8. The method of claim 5 wherein said red blood cells are suitable for storage for up to 42 days and wherein after storage for 42 days, the percent hemolysis of said red blood cells is less than about 0.4%.

9. A method for providing viable red blood cells comprising:

a) providing a quantity of whole blood;

b) combining said whole blood with a selected quantity of a phosphate-free anticoagulant, wherein one liter of said anticoagulant comprises approximately 7.3 g of citric acid, 22.0 g of trisodium citrate and 24.5 g of dextrose;

c) separating said anticoagulated whole blood into components to provide concentrated red blood cells;

d) combining said red blood cells with a solution, wherein one liter of said solution comprises approximately 22.0 g dextrose, 0.27 g adenine, 7.5 g mannitol and 9.0 g sodium chloride, whereby said red blood cells, if stored for a period of 42 days, maintain a red blood cell ATP level that is not less than approximately 80% of the initial ATP level at the beginning of the storage period.