Red blood cell products and the storage of red blood cells in containers free of phthalate plasticizer

Patent metadata

Field	Value
Publication number	US-11833175-B2
Application number	US-202117238804-A
Country	US
Kind code	B2
Filing date	Apr 23, 2021
Priority date	Sep 19, 2011
Publication date	Dec 5, 2023
Grant date	Dec 5, 2023

Abstract

Red blood cell products and compositions are disclosed. The product includes a container made from PVC or a non-PVC material that is substantially free of a phthalate plasticizer but otherwise includes one or more non-phthalate plasticizers or extractable agents. The product includes a RBC concentrate which has been combined with an additive solution for storing the RBCs.

First claim

The invention claimed is:

1. A method for providing a transfusible red blood cell product substantially free of phthalate plasticizer comprising:
(a) deriving red blood cell concentrate from whole blood;
(b) combining said concentrated red blood cells with a hypotonic solution; and
(c) storing said combination of concentrated red blood cells and a hypotonic additive solution in a container that includes a polymeric material that is substantially free of phthalate and including a first extractable plasticizer comprising 1, 2-cyclohexane dicarboxylic acid diisononyl ester and a second extractable plasticizer comprising a citrate ester.

2. The method of claim 1 wherein said red blood cell product is stored in said container for at least 42 days.

3. The method of claim 1 wherein said polymeric material is further combined with a plasticizer comprising triethylhexyltrimellitate (TEHTM).

4. The method of claim 1 wherein said polymeric material comprises polyvinyl chloride (PVC).

5. The method of claim 1 further comprising substantially removing one or both of leukocytes and prions from red blood cells by passing said red blood cells through a filter.

6. The method of claim 5 comprising removing one or both of leukocytes and prions from said red blood cells by passing said red blood cell concentrate through a leuko-reduction filter.

7. The method of claim 6 comprising combining said red blood cell concentrate with said hypotonic additive solution prior to passing said red blood cell concentrate through a leuko-reduction filter.

8. The method of claim 5 comprising removing one or both of leukocytes and prions from said red blood cells by passing said whole blood prior to deriving said red blood cell concentrate through a leuko-reduction filter.

Assignees

• Fenwal Inc

Inventors

• Radwanski Katherine
• Sandford Craig L
• Min Kyungyoon
• Blickhan Bryan
• Lynn Daniel
• Mui Tat

Classifications

• A01N1/148

  with provisions specially adapted for transporting · CPC title

• A01N1/146

  Non-refrigerated containers specially adapted for transporting or storing living parts whilst preserving · CPC title

• A01N1/126 Primary

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

• A61K35/18 Primary

  Erythrocytes (haemoglobin A61K38/42) · CPC title

• A01N1/0226

  Human Necessities · mapped topic