Devices, systems, and methods for reducing levels of pro-inflammatory or anti-inflammatory stimulators or mediators in blood products

• US 20020197249A1
• Filed: 12/21/2001
• Published: 12/26/2002
• Est. Priority Date: 04/10/2001
• Status: Abandoned Application

• Current Assignee: RenalTech International LLC
• Original Assignee: RenalTech International LLC
• Inventors: Winchester, James F., Davankov, Vadim, Pavlova, Ludmila, Salsberg, Jamie A., Brady, James A., Norris, Frank M., Tsyurupa, Maria, Quartararo, Peter J. Jr.
• Application Number:
  US10/032,802
• Publication Number:
  US 20020197249A1
• Time in Patent Office: Days
• US Class Current: 424/140.1
• 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: A61M 1/16 with membranes
• CPC Class Codes: A61M 1/1678 intracorporal peritoneal dialysis A61M1/28
• CPC Class Codes: A61M 1/1686 by heat
• CPC Class Codes: A61M 1/169 using chemical substances
• CPC Class Codes: A61M 1/1696 with dialysate regeneration
• CPC Class Codes: A61M 1/1698 Blood oxygenators with or without heat-exchangers intracorporal A61M1/1678; manufacturing of membranes therefor B01D67/00; semi-permeable membranes for separation processes characterised by their properties B01D69/00; semi-permeable membranes characterised by their material B01D71/00
• CPC Class Codes: A61M 1/28 Peritoneal dialysis ; Other peritoneal treatment, e.g. oxygenation
• CPC Class Codes: A61M 1/281 Instillation other than by gravity
• CPC Class Codes: A61M 1/284 Continuous flow peritoneal dialysis [CFPD]
• CPC Class Codes: A61M 1/34 Filtering material out of the blood by passing it through a membrane, i.e. hemofiltration or diafiltration
• CPC Class Codes: A61M 1/3403 Regulation parameters
• CPC Class Codes: A61M 1/3486 Biological, chemical treatment, e.g. chemical precipitation; treatment by absorbents
• CPC Class Codes: A61M 1/3679 by absorption A61M1/3675 takes precedence
• CPC Class Codes: A61M 1/3681 by irradiation
• CPC Class Codes: B01D 39/04 Organic material, e.g. cellulose, cotton
• CPC Class Codes: B01J 20/26 Synthetic macromolecular compounds
• CPC Class Codes: B01J 20/261 obtained by reactions only involving carbon to carbon unsaturated bonds macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds per se C08F
• CPC Class Codes: B01J 20/321 consisting of a polymer obtained by reactions involving only carbon to carbon unsaturated bonds
• CPC Class Codes: B01J 20/327 : Polymers obtained by reactions involving only carbon to carbon unsaturated bonds
• CPC Class Codes: B01J 20/3272 : Polymers obtained by reactions otherwise than involving only carbon to carbon unsaturated bonds
• CPC Class Codes: B01J 20/3293 : Coatings on a core, the core being particle or fiber shaped, e.g. encapsulated particles, coated fibers

Abstract

Devices, systems, and methods reduce levels of pro-inflammatory or anti-inflammatory stimulators or mediators in blood by selective adsorption. The devices, systems, and methods are useful in situations where abnormal levels of or unregulated or excessive interaction among pro-inflammatory or anti-inflammatory stimulators or mediators occur, or during events that do induce or have the potential for inducing abnormal production of pro-inflammatory or anti-inflammatory stimulators or mediators. The devices, systems, and methods serve to prevent, control, reduce, or alleviate the severity of the inflammatory response and disease states that are associated with abnormal levels of or unregulated or excessive interaction among pro-inflammatory or anti-inflammatory stimulators or mediators.

Claims

1. A blood processing system comprising a blood component product harvested from the blood drawn from an individual, a container sized to receive the blood component product, and a device communicating with the container to remove cytokines or other species of pro-inflammatory or anti-inflammatory stimulators or mediators from the blood component product.

2. A system according to claim 1

wherein the blood component product includes a red blood cell component.

3. A system according to claim 1

wherein the blood component product includes a platelet component.

4. A system according to claim 1

wherein the blood component product includes a white blood cell component.

5. A system according to claim 1

wherein the blood component product includes a plasma component.

6. A system according to claim 1

wherein the device includes an adsorption medium to remove cytokines or other species of pro-inflammatory or anti-inflammatory stimulators or mediators.

7. A system according to claim 6

wherein the adsorption medium is characterized by a Biocompatibility Index of not greater than 14.

8. A system according to claim 7

wherein the Biocompatibility Index is not greater than 7.

9. A system according to claim 1 or 2

wherein the device includes an adsorption medium to remove cytokines or other species of pro-inflammatory or anti-inflammatory stimulators or mediators, the adsorption medium comprising a polymeric material.

10. A system according to claim 9

wherein the polymeric material comprises particles prepared by polymerization or copolymerization of a monomer selected from a group consisting of styrene, ethylstyrene, α

-methylstyrene, divinylbenzene, di isopropenyl benzene, trivinylbenzene, and alkyl methacrylate.

11. A system according to claim 9

wherein the polymeric material comprises particles formed from crosslinked polystyrene-type resins having a surface modified to minimize activation of blood complement system.

12. A system according to claim 9

wherein the polymeric material comprises particles formed from a porous hydrophobic divinylbenzene copolymer having a surface modified to include surface exposed functional groups selected from the group of polymers of 2-hydroxyethyl methacrylate, N-vinylpyrrolidine, N-vinylcaprolactame and N-acrylamide.

13. A system according to claim 9

wherein the polymeric material comprises particles formed by polymerization of aromatic divinyl compounds or their copolymerization with aromatic monovinyl compounds in the presence of porogens or mixtures of porogens with properties close to those of θ

-solvents.

15. A system according to claim 14

wherein the blood component product includes a red blood cell component.

16. A system according to claim 14

wherein the blood component product includes a platelet component.

17. A system according to claim 14

wherein the blood component product includes a white blood cell component.

18. A system according to claim 14

wherein the blood component product includes a plasma component.

19. A system according to claim 14

wherein the means for removing cytokines or other species of pro-inflammatory or anti-inflammatory stimulators or mediators includes an adsorption medium to remove cytokines or other species of pro-inflammatory or anti-inflammatory stimulators or mediators.

20. A system according to claim 19

wherein the adsorption medium is characterized by a Biocompatibility Index of not greater than 14.

21. A system according to claim 20

wherein the Biocompatibility Index is not greater than 7.

22. A system according to claim 14

wherein the device includes an adsorption medium to remove cytokines or other species of pro-inflammatory or anti-inflammatory stimulators or mediators, the adsorption medium comprising a polymeric material.

23. A system according to claim 22

wherein the polymeric material comprises particles prepared by polymerization or copolymerization of a monomer selected from a group consisting of styrene, ethylstyrene, α

-methylstyrene, divinylbenzene, di isopropenyl benzene, trivinylbenzene, and alkyl methacrylate.

24. A system according to claim 22

wherein the polymeric material comprises particles formed from crosslinked polystyrene-type resins having a surface modified to minimize activation of blood complement system.

25. A system according to claim 22

wherein the polymeric material comprises particles formed from a porous hydrophobic divinylbenzene copolymer having a surface modified to include surface exposed functional groups selected from the group of polymers of 2-hydroxyethyl methacrylate, N-vinylpyrrolidine, N-vinylcaprolactame and N-acrylamide.

26. A system according to claim 22

wherein the polymeric material comprises particles formed by polymerization of aromatic divinyl compounds or their copolymerization with aromatic monovinyl compounds in the presence of porogens or mixtures of porogens with properties close to those of e-solvents.

28. A method according to claim 27

wherein the blood component product includes a red blood cell component.

29. A method according to claim 27

wherein the blood component product includes a platelet component.

30. A method according to claim 27

wherein the blood component product includes a white blood cell component.

31. A method according to claim 27

wherein the blood component product includes a plasma component.

32. A method according to claim 27

wherein the removing step includes use of an adsorption medium to remove cytokines or other species of pro-inflammatory or anti-inflammatory stimulators or mediators.

33. A method according to claim 32

wherein the adsorption medium comprises a polymeric material.

34. A method according to claim 33

wherein the polymeric material comprises particles prepared by polymerization or copolymerization of a monomer selected from a group consisting of styrene, ethylstyrene, α

-methylstyrene, divinylbenzene, di isopropenyl benzene, trivinylbenzene, and alkyl methacrylate.

35. A method according to claim 33

wherein the polymeric material comprises particles formed from crosslinked polystyrene-type resins having a surface modified to minimize activation of blood complement system.

36. A method according to claim 33

wherein the polymeric material comprises particles formed from a porous hydrophobic divinylbenzene copolymer having a surface modified to include surface exposed functional groups selected from the group of polymers of 2-hydroxyethyl methacrylate, N-vinylpyrrolidine, N-vinylcaprolactame and N-acrylamide.

37. A method according to claim 33

wherein the polymeric material comprises particles formed by polymerization of aromatic divinyl compounds or their copolymerization with aromatic monovinyl compounds in the presence of porogens or mixtures of porogens with properties close to those of θ

-solvents.

14. A system for collecting a blood component product comprising

means for processing the blood drawn from an individual into a blood component product,

a storage container,

means for collecting the blood component product in the storage container, and

means for removing cytokines or other species of pro-inflammatory or anti-inflammatory stimulators or mediators from the blood component product before, during, or after its collection in the storage container.

27. A method for collecting a blood component product comprising the steps of

processing the blood drawn from an individual into a blood component product,

collecting the blood component product in a storage container, and

removing cytokines or other species of pro-inflammatory or anti-inflammatory stimulators or mediators from the blood component product before, during, or after its collection in the storage container.