Devices for component removal during blood collection, and uses thereof

• US 20070020629A1
• Filed: 02/13/2004
• Published: 01/25/2007
• Est. Priority Date: 02/13/2003
• Status: Active Grant

• Current Assignee: Becton, Dickinson & Co
• Original Assignee: Becton, Dickinson & Co
• Inventors: Haywood, Bruce, Ross, Julie
• Granted Patent: US 8,603,345 B2
• Time in Patent Office: Days
• US Class Current: 435/6
• CPC Class Codes: B01L 2200/16 Reagents, handling or storing thereof
• CPC Class Codes: B01L 3/50215 using a float to separate phases
• CPC Class Codes: B01L 3/5082 Test tubes per se
• CPC Class Codes: G01N 33/5304 Reaction vessels, e.g. agglutination plates for solid-phase systems G01N33/543
• CPC Class Codes: G01N 33/5306 Improving reaction conditions, e.g. reduction of non-specific binding, promotion of specific binding
• CPC Class Codes: G01N 33/54346 Nanoparticles
• CPC Class Codes: G01N 33/54386 Analytical elements
• CPC Class Codes: Y10T 436/25375 Liberation or purification of sample or separation of material from a sample [e.g., filtering, centrifuging, etc.]

Abstract

The invention relates to a device and method for collecting blood whereby certain target components are isolated or removed from the blood sample at the time of collecting the blood, as well as methods for using such devices.

Claims

1. A device for collecting blood comprising a reservoir and affinity molecules, wherein said affinity molecules are exposed to said blood during the time of collecting said blood.

2. The device of claim 1, wherein said affinity molecules are completely contained within said reservoir.

3. The device of claim 2, wherein said reservoir comprises at least one insert.

4. The device of claim 3, wherein said at least one insert comprises said affinity molecules.

5. The device of claim 4, wherein said at least one insert comprises one or more beads.

6. The device of claim 4, wherein said at least one insert is a paddle.

7. The device of claim 4, wherein said affinity molecules have an affinity towards undesired targets.

8. The device of claim 4, wherein said affinity molecules have an affinity towards desired targets.

9. The device of claim 4, wherein said affinity molecules are selected from the group consisting of antibodies, antibody fragments, enzymes, fragments of enzymes, enzyme substrates, fragments of enzyme substrates, nucleotides, oligonucleotides, polynucleotides, receptors, aptamers, nanobodies, fragments of receptors, ligands, fragments of enzymes, other proteins, amino acids, peptides, polypeptides, oligopeptides, saccharides, disaccharides, polysaccharides, glycoproteins, proteoglycans, and natural and synthetic polymers.

10. The device of claim 9, wherein said affinity molecules are antibodies or fragments thereof.

11. The device of claim 10, wherein said antibody or fragment thereof binds at least one protein within said blood.

12. The device of claim 11, wherein said at least one protein is selected from the group consisting of albumin, immunoglobulins, fibrinogen, protease inhibitors, antichymotrypsin, antithrombin, macroglobulins, inter-alpha-trypsin inhibitor, C1 inhibitor, plasmin inhibitor, heparin cofactor II, tranferrin, immunoglobulin M, haptoglobin complement and alpha-1 antitrypsin.

13. The device of claim 12, wherein said protein is albumin.

14. The device of claim 2, wherein said affinity molecules are coated onto the interior of said reservoir.

15. The device of claim 14, wherein said affinity molecules are coated onto the interior of side walls of said reservoir.

16. The device of claim 15, wherein said interior side walls are ridged.

17. The device of claim 14, wherein said affinity molecules have an affinity towards undesired targets.

18. The device of claim 14, wherein said affinity molecules have an affinity towards desired targets.

19. The device of claim 14, wherein said affinity molecules are selected from the group consisting of antibodies, antibody fragments, enzymes, fragments of enzymes, enzyme substrates, fragments of enzyme substrates, nucleotides, oligonucleotides, polynucleotides, receptors, aptamers, nanobodies, fragments of receptors, ligands, fragments of enzymes, other proteins, amino acids, peptides, polypeptides, oligopeptides, saccharides, disaccharides, polysaccharides, glycoproteins, proteoglycans, and natural and synthetic polymers.

20. The device of claim 19, wherein said affinity molecules are antibodies or fragments thereof.

21. The device of claim 20, wherein said antibody or fragment thereof binds at least one protein within said blood.

22. The device of claim 21, wherein said at least one protein is selected from the group consisting of albumin, immunoglobulins, fibrinogen, protease inhibitors, antichymotrypsin, antithrombin, macroglobulins, inter-alpha-trypsin inhibitor, C1 inhibitor, plasmin inhibitor, heparin cofactor II, tranferrin, immunoglobulin M, haptoglobin complement and alpha-1 antitrypsin.

23. The device of claim 22, wherein said protein is albumin.

24. The device of claim 1, wherein said affinity molecules are not completely contained within said reservoir.

25. The device of claim 24, wherein said affinity molecules are located within an affinity column, wherein said affinity column is linked to said reservoir.

26. The device of claim 25, wherein the interior walls of said affinity column comprise said affinity molecules.

27. The device of claim 25, wherein said affinity column comprises beads.

28. The device of claim 27, wherein said beads comprise said affinity molecules.

29. The device of claim 25, wherein said affinity molecules have an affinity towards undesired targets.

30. The device of claim 25, wherein said affinity molecules have an affinity towards desired targets.

31. The device of claim 1, wherein said reservoir comprises tubing.

32. The device of claim 31, wherein said tubing comprises said affinity molecules.

33. The device of claim 32, wherein said affinity molecules are coated on the interior walls of said tubing.

34. The device of claim 31, wherein said tubing further comprises beads.

35. The device of claim 34, wherein said beads comprise said affinity molecules.

36. The device of claim 31, wherein said affinity molecules have an affinity towards undesired targets.

37. The device of claim 31, wherein said affinity molecules have an affinity towards desired targets.

38. A method of collecting blood, comprising exposing said blood to affinity molecules during the time of said collection.

39. The method of claim 38, wherein establishing venous access through use of a blood collection device initiates the time of said collection.

40. The method of claim 38, wherein said affinity molecules are selected from the group consisting of antibodies, antibody fragments, enzymes, fragments of enzymes, enzyme substrates, fragments of enzyme substrates, nucleotides, oligonucleotides, polynucleotides, receptors, aptamers, nanobodies, fragments of receptors, ligands, fragments of enzymes, other proteins, amino acids, peptides, polypeptides, oligopeptides, saccharides, disaccharides, polysaccharides, glycoproteins, proteoglycans, and natural and synthetic polymers.

41. The method of claim 40, wherein said affinity molecules are antibodies or fragments thereof.

42. The method of claim 41, wherein said antibody or fragment thereof binds at least one protein within said blood.

43. The method of claim 42, wherein said at least protein is selected from the group consisting of albumin, immunoglobulins, fibrinogen, protease inhibitors, antichymotrypsin, antithrombin, macroglobulins, inter-alpha-trypsin inhibitor, C1 inhibitor, plasmin inhibitor, heparin cofactor II tranferrin, immunoglobulin M, haptoglobin complement and alpha-1 antitrypsin.

44. The method of claim 43, wherein said protein is albumin.

45. The method of claim 38, comprising wherein said affinity molecules are completely enclosed within a reservoir.

46. The method of claim 45, wherein said reservoir comprises at least one insert.

47. The method of claim 46, wherein said at least insert comprises said affinity molecules.

48. The method of claim 47, wherein said affinity molecules are selected from the group consisting of antibodies, antibody fragments, enzymes, fragments of enzymes, enzyme substrates, fragments of enzyme substrates, nucleotides, oligonucleotides, polynucleotides, receptors, aptamers, nanobodies, fragments of receptors, ligands, fragments of enzymes, other proteins, amino acids, peptides, polypeptides, oligopeptides, saccharides, disaccharides, polysaccharides, glycoproteins, proteoglycans, and natural and synthetic polymers.

49. The method of claim 48, wherein said affinity molecules are antibodies or fragments thereof.

50. The method of claim 49, wherein said antibody or fragment thereof binds at least one protein within said blood.

51. The method of claim 50, wherein said at least one protein is selected from the group consisting of albumin, immunoglobulins, fibrinogen, protease inhibitors, antichymotrypsin, antithrombin, macroglobulins, inter-alpha-trypsin inhibitor, C1 inhibitor, plasmin inhibitor, heparin cofactor II, tranferrin, immunoglobulin M, haptoglobin complement and alpha-1 antitrypsin.

52. The method of claim 51, wherein said protein is albumin.

53. The method of claim 38, wherein said affinity molecules are not completely contained within said reservoir.

54. The method of claim 53, wherein said affinity molecules are located within an affinity column, wherein said affinity column is linked to said reservoir.

55. The method of claim 45, wherein said reservoir comprises tubing.

56. The method of claim 55, wherein said tubing comprises said affinity molecules.

57. A method for collecting a biological fluid sample from a patient, comprising:

a) providing an evacuated sample collection reservoir comprising affinity molecules; and

b) exposing said biological fluid from said patient to said sample collection reservoir.

58. The method of claim 57, wherein said affinity molecules target at least two molecules selected from the group consisting of albumin, Immunoglobulin G (IgG), transferrin, Immunoglobulin A (IgA), Immunoglobulin M (IgM), and α

1-antitrypsin.

59. The method of claim 58, wherein said target molecules are IgG and albumin.

60. The method of claim 57, wherein said evacuated sample collection reservoir comprises an additive selected from the group consisting of a protease inhibitor, ethylenediaminetetraacetic acid (EDTA), sodium citrate, heparin, and a clotting factor.

61. The method of claim 57, wherein a gel electrophoresis of the exposed fluid exhibits visually distinct results compared to an identical gel electrophoresis of the identical fluid exposed to an identical evacuated sample collection container free of the affinity molecules.