Polymeric sorbent for removal of impurities from whole blood and blood products

Inventors

Chan, Phillip P.Capponi, Vincent J.Golobish, Thomas D.Ali, Humayra Begum

Assignees

Cytosorbents Corp

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Publication Number

US-10426158-B2

Patent

Publication Date

2019-10-01

Expiration Date


Abstract

The invention concerns methods of treating stored blood and blood products maximizing shelf life and/or minimizing transfusion related complications such as non¬ hemolytic transfusion reactions such as fever, transfusion-related acute lung injury (TRALI), transfusion associated dyspnea (TAD), and allergic reactions by removing undesirable molecules in the blood and blood products milieu through use of a sorbent.

Core Innovation

The invention provides a device comprising a plurality of porous sorbent polymeric beads for sorbing impurities from blood. The beads include a biocompatible polymer and have particles with a diameter in the range of 0.1 micrometer to 2 centimeters, together with a pore structure defined by a total pore volume of pore size in the range of 50 Å to 40,000 Å that is greater than 0.5 cc/g to 5.0 cc/g dry polymer.

The beads further have a skeletal density in the range of about 1.0 g/ml to about 1.3 g/ml and include divinylbenzene and 4-chlorostyrene. The porous polymeric bead configuration is described as biocompatible porous polymeric sorbent beads, including optionally neutrally buoyant or near-neutral buoyancy behavior in packed RBCs, for maintaining contact with blood and supporting impurity removal.

The device houses the plurality of beads in a suitable container intended for storage of blood or blood product with direct contact between the beads and the blood or blood product, or in a cartridge used to filter blood or blood product at time of collection or at the point of use during transfusion. The invention addresses removal of biologically active molecules and other impurities from stored blood to mitigate transfusion complications and extend shelf life.

Claims Coverage

The provided independent claim covers a device structure and its placement for sorbing impurities from blood using porous sorbent polymeric beads with specified particle size, pore structure, total pore volume, and skeletal density, with divinylbenzene and 4-chlorostyrene chemistry, and with specified housing/container or cartridge configurations for storage and/or filtration. The inventive features appear in one explicitly provided independent claim.

Porous sorbent polymeric beads for blood impurities removal

A device comprising a plurality of porous sorbent polymeric beads for sorbing impurities from blood, wherein the beads comprise a biocompatible polymer comprising particles having a diameter in the range for 0.1 micrometer to 2 centimeters.

Pore structure defined by total pore volume in a pore size range

The beads have a pore structure such that the total pore volume of pore size in the range of 50 Å to 40,000 Å is greater than 0.5 cc/g to 5.0 cc/g dry polymer.

Container or cartridge providing direct contact during storage or transfusion filtration

The plurality of beads are housed in a suitable container intended for storage of blood or blood product wherein said beads would be in direct contact with said blood or blood product, or contained in a cartridge used to filter blood or blood product at time of collection as said blood product is placed in a bag for storage, or at the point of use during transfusion when said blood or blood product is transfused from the bag to a patient.

Divinylbenzene and 4-chlorostyrene beads with specified skeletal density

The beads comprising divinylbenzene and 4-chlorostyrene and having a skeletal density in the range of from about 1.0 g/ml to about 1.3 g/ml.

Within the provided content, the claims coverage centers on a device using biocompatible porous polymeric beads with specified particle diameter, pore size/total pore volume, and skeletal density, using divinylbenzene and 4-chlorostyrene, and configured either for direct contact during blood storage or for filtration at collection or point of use during transfusion.

Stated Advantages

Mitigate transfusion complications.

Extend shelf life of stored blood/blood products.

Remove biologically active molecules and impurities from stored blood or blood products.

Documented Applications

Treat stored blood or blood products by sorbing biologically active molecules and other impurities to mitigate transfusion complications, with bead-containing containers used for storage direct contact and/or cartridge-based filtration at time of collection or at the point of use during transfusion.

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