Method and device for monitoring platelet function

• US 20060269978A1
• Filed: 04/24/2006
• Published: 11/30/2006
• Est. Priority Date: 04/25/2005
• Status: Abandoned Application

• Current Assignee: PlaCor, Inc.
• Original Assignee: PlaCor, Inc.
• Inventors: Swenson, Vincent J., Haworth, William S.
• Application Number:
  US11/409,735
• Publication Number:
  US 20060269978A1
• Time in Patent Office: Days
• US Class Current: 435/13
• CPC Class Codes: C12Q 1/56 involving blood clotting factors, e.g. involving thrombin, thromboplastin, fibrinogen
• CPC Class Codes: G01N 33/4905 Determining clotting time of blood by chemical methods G01N33/86, C12Q1/54

Abstract

A method of monitoring platelet function comprising: passing blood removed from a mammal through a passageway comprising a spring to contact the spring to generate a platelet mass in the passageway; and monitoring the flow or composition of the blood in the passageway to detect formation of the platelet mass. Devices and articles for performing the methods are also described.

Claims

1. A method of monitoring platelet function comprising:

passing blood removed from a mammal through a passageway comprising a spring to contact the spring to generate a platelet mass in the passageway; and

monitoring the flow or composition of the blood in the passageway to detect formation of the platelet mass.

2. The method of claim 1, wherein the amount of time to form a platelet mass is measured.

3. The method of claim 1, wherein the spring is made of beryllium copper, gold-plated beryllium copper, or stainless steel.

4. The method of claim 1, wherein the spring is made of passivated stainless steel.

5. The method of claim 1, wherein the spring is mounted transversely to the passageway.

6. The method of claim 1, wherein the flow of the blood in the passageway is monitored.

7. The method of claim 6, wherein the flow is monitored by monitoring the pressure of the blood in the passageway.

8. The method of claim 10, wherein the pressure is monitored with a pressure transducer.

9. The method of claim 6, wherein the flow is monitored optically.

10. The method of claim 9, wherein the flow is monitored with a light-emitting diode and a light detector.

11. The method of claim 1, wherein the composition of the blood in the passageway is monitored.

12. The method of claim 1, wherein the passageway and blood do not comprise an added anti-coagulant.

13. The method of claim 1, wherein the passageway does not comprise an added biological agent that activates platelets.

14. The method of claim 1, wherein the blood does not comprise an added biological agent that activates platelets.

15. The method of claim 1, wherein the passageway and blood do not comprise an added chemical agent that activates platelets.

16. The method of claim 1, wherein no biological or chemical agents are added to the removed blood.

17. The method of claim 1, wherein less than 0.4 ml of blood is removed from the body of the mammal.

18. The method of claim 1, wherein less than 20 μ

l of blood passes through the passageway.

19. The method of claim 1, wherein the blood passes bidirectionally through the passageway.

20. The method of claim 1, wherein the blood is whole blood.

21. The method of claim 1, wherein the blood is fractionated blood.

22. The method of claim 1, wherein the mammal is treated with an anti-platelet agent.

23. The method of claim 22, wherein the anti-platelet agent comprises a cyclooxygenase inhibitor, an ADP inhibitor, a GPIIbIIIa inhibitor, or a combination thereof.

24. The method of claim 1, wherein the platelet mass that forms is substantially depleted in fibrin in comparison to a normal clot.

25. A method of monitoring platelet function comprising:

passing blood removed from a mammal through two or more passageways, the two or more passageways comprising an obstruction or irregularity, to contact the obstruction or the wall of the passageways at the irregularity, to generate a platelet mass in the two or more passageways; and

monitoring the flow or composition of the blood in the passageways to detect formation of the platelet masses.

26. The method of claim 25, wherein the amount of time to form a platelet mass is measured.

27. The method of claim 25, wherein the formations of the platelet masses in the two or more passageways are detected simultaneously.

28. The method of claim 25, wherein the two or more passageways comprise an obstruction selected from a spring, wire form, metal screen, woven cloth, sheet metal with an orifice, sheet metal forms, polymeric fibers, natural fibers, cellulose fibers, metal wires, suture strands, laser etched or molded plastic formations, glass formations or glass beads.

29. The method of claim 28, wherein the obstruction is a spring.

30. The method of claim 29, wherein the spring is made of beryllium copper, gold-plated beryllium copper, or stainless steel.

31. The method of claim 29, wherein the spring is made of passivated stainless steel.

32. The method of claim 29, wherein the spring is mounted transversely to the passageway.

33. The method of claim 25, wherein the flow of the blood in the two or more passageways is monitored.

34. The method of claim 33, wherein the flow is monitored by monitoring the pressure of the blood in the two or more passageways.

35. The method of claim 34, wherein the pressure is monitored with a pressure transducer.

36. The method of claim 33, wherein the flow is monitored optically.

37. The method of claim 36, wherein the flow is monitored with a light-emitting diode and a light detector.

38. The method of claim 25, wherein the composition of the blood in the two or more passageways is monitored.

39. The method of claim 25, wherein the passageways and blood do not comprise an added anti-coagulant.

40. The method of claim 25, wherein the passageways do not comprise an added biological agent that activates platelets.

41. The method of claim 25, wherein the blood does not comprise an added biological agent that activates platelets.

42. The method of claim 25, wherein the passageways and blood do not comprise an added chemical agent that activates platelets.

43. The method of claim 25, wherein no biological or chemical agents are added to the removed blood.

44. The method of claim 25, wherein less than 0.4 ml of blood is removed from the body of the mammal.

45. The method of claim 25, wherein less than 50 μ

l of blood passes through the two or more passageways.

46. The method of claim 25, wherein the blood passes bidirectionally through the two or more passageways.

47. The method of claim 25, wherein the blood is whole blood.

48. The method of claim 25, wherein the blood is fractionated blood.

49. The method of claim 25, wherein the mammal is treated with an anti-platelet agent.

50. The method of claim 49, wherein the anti-platelet agent comprises a cyclooxygenase inhibitor, an ADP inhibitor, a GPIIbIIIa inhibitor, or a combination thereof.

51. The method of claim 25, wherein the platelet masses that form are substantially depleted in fibrin in comparison to a normal clot.

52. A device for monitoring platelet function, comprising:

a fluid-tight material forming a passageway;

a pump functionally linked to the passageway for pumping blood through the passageway;

a spring within the passageway, arranged such that when blood is pumped through the passageway to contact the spring, a platelet mass forms on or near the spring; and

a detector for detecting the flow of blood through the passageway to detect formation of the platelet mass.

53. A device for monitoring platelet function, comprising:

a fluid-tight material forming two or more passageways;

two or more pumps functionally linked to the passageways for pumping blood through the passageways;

wherein the two or more passageways comprise an obstruction or irregularity arranged such that when blood is pumped through the passageways to contact the obstruction or wall of the passageways at the irregularity, a platelet mass forms on the wall of the passageways at or near the irregularity or at or near the obstruction; and

a detector for detecting the flow of blood through the passageways to detect formation of the platelet masses.

54. A device for monitoring platelet function, comprising:

a fluid-tight material forming two or more passageways;

two or more pumps functionally linked to the passageways for pumping blood through the passageways;

wherein the two or more passageways comprise an obstruction or irregularity arranged such that when blood is pumped through the passageways to contact the obstruction or wall of the passageways at the irregularity, a platelet mass forms on the wall of the passageways at or near the irregularity or at or near the obstruction; and

a detector for detecting the composition of blood in the passageways to detect formation of the platelet masses.

55. An article for use in a device for monitoring platelet function, the article comprising:

a fluid-tight material forming a passageway; and

a spring in the passageway, arranged such that when blood is pumped through the passageway to contact the spring, a platelet mass forms on or near the spring.

56. The article of claim 55, wherein the spring is made of beryllium copper, gold-plated beryllium copper, or stainless steel.

57. The article of claim 55, wherein the spring is made of passivated stainless steel.

58. The article of claim 55, wherein the spring is mounted transversely to the passageway.

59. The article of claim 55, wherein the length of the spring is from 0.025 cm to 0.15 cm.

60. An article for use in a device for monitoring platelet function, comprising:

a fluid-tight material forming two or more passageways;

wherein two or more passageways comprise an obstruction or irregularity arranged such that when blood is pumped through the two or more passageways to contact the obstruction or the wall of the passageway at the irregularity, a platelet mass forms at or near the obstruction or on the wall of the passageway at or near the irregularity.

61. The article of claim 60, wherein the two or more passageways comprise an obstruction selected from a spring, wire form, metal screen, woven cloth, sheet metal with an orifice, sheet metal forms, polymeric fibers, natural fibers, cellulose fibers, metal wires, suture strands, laser etched or molded plastic formations, glass formations or glass beads.

62. The article of claim 60, wherein the obstruction is a spring.

63. The article of claim 62, wherein the spring is made of beryllium copper, gold-plated beryllium copper, or stainless steel.

64. The article of claim 62, wherein the spring is made of passivated stainless steel.

65. The article of claim 62, wherein the spring is mounted transversely to the passageway.

66. The article of claim 62, wherein the length of the spring is from 0.025 cm to 0.15 cm.