Methods for storing red blood cell products

Patent metadata

Field	Value
Publication number	US-9409128-B2
Application number	US-201313835127-A
Country	US
Kind code	B2
Filing date	Mar 15, 2013
Priority date	Oct 23, 2009
Publication date	Aug 9, 2016
Grant date	Aug 9, 2016

Abstract

Methods and systems for processing and conditioning red blood cells are disclosed. The methods and systems may be used to make a readily transfusible red blood cell product with reduced plasma. In general, the plasma content of the supernatant of the red blood cell product is no greater than about 15%. The red blood cell products are prepared using the disclosed methods and systems remain transfusible for up to 42 days.

First claim

The invention claimed is:

1. A method for preparing transfusible and concentrated red blood cells with reduced waste products, the method comprising:
(a) introducing concentrated red blood cells that have been separated from whole blood and an additive solution comprising glucose, a buffer, mannitol adenine and a salt to stabilize said concentrated red blood cells into a multi-chambered container system, said multi-chambered container system including an outer container comprising a pair of sealed walls defining an interior chamber of said outer container, an inner container housed within said interior chamber of said outer container, said inner container comprising walls of a porous material defining an interior chamber of said inner container, said interior chamber of said inner container having a volume smaller than the volume of said interior chamber of said outer container, said porous material selected to allow passage of only certain components or compounds across said wall but prevent the passage of red blood cells, a port communicating with said interior chamber of said outer container and at least one port communicating with said interior chamber of said inner container wherein:
(i) said concentrated red blood cells are introduced into the interior chamber of said inner container through the port communicating therewith;
(ii) said nutrient containing additive solution is introduced into the interior chamber of said outer container through the port communicating therewith; and

b) holding said concentrated red blood cells within the interior chamber of said inner container of said container system for a selected period of time.

2. The method of claim 1 wherein said additive solution is selected for prolonging the storage shelf life of said red blood cells.

3. The method of claim 1 wherein said additive solution comprises about 20 to about 140 mM of glucose, about 20 to about 100 mM mannitol, about 15 to about 40 mM sodium phosphate dibasic, about 3 to about 90 mM sodium citrate and about 1 to 2.5 mM adenine and has a pH of greater than 8.0.

4. The method of claim 1 wherein said porous material of said inner container has a porosity selected to allow passage of compounds and ions of said additive solution across said porous material.

5. The method of claim 1 wherein said porous material of said inner container has a porosity selected to allow passage of plasma between said inner container to said interior chamber of said outer container.

6. The method of claim 1 further comprising reducing the concentration of small molecules in said red blood cells.

7. The method of claim 6 further comprising reducing the concentration of one or more compounds selected from the group of cytokines, chloride ions and free hemoglobin.

8. The method of claim 1 comprising diluting said concentrated red blood cells before introducing said concentrated red blood cells into said container system.

9. The method of claim 1 wherein said selected period of time is at least 42 days.

10. The method of claim 1 wherein as a percentage of plasma, additive solution and anticoagulant within the container system, no more than approximately 15% comprises plasma.

11. The method of claim 1 further comprising removing the contents of the interior chamber of said outer container through an access port.

12. The method of claim 1 further comprising removing said concentrated red blood cells from said inner container through an access port that communicates with the interior chamber of said inner container after said selected period of time.

Assignees

• Fenwal Inc

Inventors

• Min Kyungyoon
• Radwanski Katherine

Classifications

• A01N1/148

  with provisions specially adapted for transporting · CPC title

• A01N1/126 Primary

  Physiologically active agents, e.g. antioxidants or nutrients · CPC title

• A61M1/0236

  with sampling means, e.g. sample bag or sampling port · CPC title

• A61M1/3693

  using separation based on different densities of components, e.g. centrifuging · CPC title

• B01D61/32 Primary

  Controlling or regulating · CPC title