ANTI-CLOTTING APPARATUS AND METHODS FOR FLUID HANDLING SYSTEM

• US 20090143711A1
• Filed: 04/28/2008
• Published: 06/04/2009
• Est. Priority Date: 10/06/2005
• Status: Active Grant

• Current Assignee: James R. Braig, Richard Keenan
• Original Assignee: James R. Braig, Richard Keenan
• Inventors: Braig, James R., Keenan, Richard
• Granted Patent: US 8,034,015 B2
• Time in Patent Office: Days
• US Class Current: 604/6.70
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/15003 for venous or arterial blood
• CPC Class Codes: A61B 5/150213 Venting means
• CPC Class Codes: A61B 5/150221 Valves
• CPC Class Codes: A61B 5/150229 Pumps for assisting the blood sampling
• CPC Class Codes: A61B 5/150755 Blood sample preparation for further analysis, e.g. by separating blood components or by mixing
• CPC Class Codes: A61B 5/150862 intermediate range, e.g. within room or building
• CPC Class Codes: A61B 5/150992 Blood sampling from a fluid line external to a patient, such as a catheter line, combined with an infusion line; blood sampling from indwelling needle sets, e.g. sealable ports, luer couplings, valves tubing connectors and couplings A61M39/00
• CPC Class Codes: A61B 5/153 Devices specially adapted for taking samples of venous or arterial blood, e.g. with syringes
• CPC Class Codes: A61B 5/155 Devices specially adapted for continuous or multiple sampling, e.g. at predetermined intervals devices loaded with multiple lancets simultaneously A61B5/15146
• CPC Class Codes: A61B 5/157 Devices characterised by integrated means for measuring characteristics of blood
• CPC Class Codes: A61M 2230/20 Blood composition characteristics
• CPC Class Codes: A61M 5/14212 Pumping with an aspiration and an expulsion action
• CPC Class Codes: G01N 21/35 using infrared light G01N21/39 takes precedence

Abstract

A method for maintaining clear passageways in an extracorporeal blood flow system. The method comprises intermittently providing one or more anti-clotting agents to a passageway of the extracorporeal blood flow system. Also disclosed is an extracorporeal blood flow system. The system comprises a passageway, and a device operatively connected to provide one or more anti-clotting agents to a least a portion of said passageway.

Claims

1. A method for inhibiting blood clot formation in a fluid handling system, the method comprising:

drawing a bodily fluid from a fluid source into a first passageway of the fluid handling system;

providing a valve in operative association with the first passageway;

providing a sample element configured to hold at least a portion of the bodily fluid;

providing a second passageway between and in fluid communication with the first passageway and the sample element;

actuating a valve to separate an analysis portion from the bodily fluid;

returning a portion of the bodily fluid to the fluid source;

providing an anti-clotting agent to only the analysis portion;

centrifuging the analysis portion into a plurality of components;

analyzing at least one of the plurality of components to determine at least one analyte level; and

displacing the analysis portion into a waste receptacle.

2. The method of claim 1, wherein the anti-clotting agent comprises a liquid.

3. The method of claim 2, wherein said providing an anti-clotting agent comprises injecting said liquid into at least a portion of said second passageway.

4. The method of claim 3, wherein the anti-clotting agent comprises a detergent.

5. The method of claim 1, wherein the anti-clotting agent comprises ultrasonic energy.

6. A system for analysis of bodily fluids comprising:

a first fluid passageway in fluid communication with a fluid source;

a second fluid passageway in fluid communication with the first passageway;

a pump configured to draw a fluid sample into the first fluid passageway from the fluid source;

a valve operatively connected to at least one of the first or second fluid passageways, the valve being configured to separate an analysis portion from the fluid sample;

an analyzer operatively connected to the second passageway, the analyzer being configured to determine the concentration of at least one analyte in the analysis portion of the fluid sample; and

an anti-clotting device operatively connected to provide one or more anti-clotting agents to only the analysis portion.

7. The system of claim 6, further comprising a waste reservoir in fluid communication with the second passageway, the waste reservoir configured to collect the analysis portion of the fluid sample so that it is not returned to the fluid source.

8. The system of claim 6, further comprising a controller configured to operate the fluid flow system such that at least a portion of the fluid sample is returned to the fluid source.

9. The system of claim 6, wherein the controller operates the pump to return a portion of the fluid sample to the fluid source.

10. The system of claim 9, wherein the controller is configured to operate the valve to prevent the analysis portion of the fluid sample from returning to the fluid source.

11. The system of claim 6, wherein one of said one or more anti-clotting agents comprises a substance infusible into the fluid sample.

12. The system of claim 11, wherein the substance infusible into the fluid sample comprises a detergent.

13. The system of claim 12, wherein said detergent comprises a protease enzyme.

14. The system of claim 11, wherein said anti-clotting device is configured to provide said infusible substance to the fluid sample when it is within at least a portion of said second passageway.

15. The system of claim 11, wherein the system is further configured to prevent the substance, or the analysis portion infused therewith, from entering the fluid source.

16. The system of claim 6, wherein said fluid flow system comprises a point-of-care analyte monitoring system.

17. The system of claim 16, wherein said point-of-care analyte monitoring system comprises an optical detection device, wherein said second passageway comprises an optical measurement cell, and wherein said one or more anti-clotting agents is provided at or near said optical measurement cell.

18. The system of claim 17, wherein said point-of-care analyte monitoring system comprises a spectroscopic analyzer.

19. The system of claim 18, wherein said spectroscopic analyzer comprises an infrared spectrometer configured to determine glucose concentration.

20. The system of claim 6, wherein one of said one or more anti-clotting agents comprises ultrasonic energy.

21. The system of claim 6, wherein said anti-clotting device comprises an ultrasound generator positionable to contact said second passageway.

22. The system of claim 21, wherein said ultrasound generator generates from approximately 2 Watts to approximately 200 Watts of ultrasonic energy.

23. The system of claim 21, wherein said ultrasound generator generates ultrasound having a frequency of approximately 40 kHz.

24. A method for providing clear passageways in a fluid flow system, the method comprising:

providing a first passageway for a fluid flow in the fluid flow system from a fluid source;

drawing a fluid sample into the fluid flow system;

separating an analysis portion from the fluid sample;

providing a second passageway configured to receive the analysis portion of the fluid sample;

providing one or more anti-clotting agents to only the analysis portion of the fluid sample;

analyzing the analysis portion of the fluid sample to determine the concentration of at least one analyte in the fluid sample; and

preventing the analysis portion of the fluid sample from being returned to the fluid source.

25. The method of claim 24, further comprising treating the analysis portion.

26. The method of claim 25, wherein treating comprises separating the analysis portion into components.

27. The method of claim 26, wherein separating the analysis portion into components comprises filtering the analysis portion.

28. The method of claim 26, wherein separating the analysis portion into components comprises centrifuging the analysis portion.

29. The method of claim 26, wherein separating the analysis portion into components comprises separating blood into blood components.

30. The method of claim 24, wherein separating the fluid sample comprises actuating a valve.

31. The method of claim 24, wherein providing one or more anti-clotting agents comprises infusing a substance into the analysis portion.

32. The method of claim 31, wherein infusing a substance comprises infusing detergent into the analysis portion.

33. The method of claim 32, wherein said detergent comprises a protease enzyme.

34. The method of claim 31, further comprising automatically preventing the substance, or the analysis portion infused therewith, from entering the fluid source.

35. The method of claim 24, wherein said fluid flow system comprises a point-of-care analyte monitoring system.

36. The method of claim 24, wherein said fluid flow system comprises an optical detection device, wherein said second passageway comprises an optical measurement cell, and wherein said one or more anti-clotting agents is provided at or near said optical measurement cell.

37. The method of claim 24, wherein said fluid flow system comprises a spectral analyzer for blood.

38. The method of claim 24, further comprising flushing the second passageway with a cleaning solution.

39. The method of claim 24, further comprising pumping residual fluids into a waste receptacle.

40. The method of claim 24, wherein said anti-clotting agents comprise ultrasonic energy.

41. The method of claim 40, wherein said providing one or more anti-clotting agents comprises positioning an ultrasound generator against at least a portion of said second passageway.

42. The method of claim 41, wherein said providing one or more anti-clotting agents comprises providing up to approximately 25 Watts of ultrasonic energy.

43. The method of claim 40, wherein said providing one or more anti-clotting agents comprises providing ultrasonic energy having a frequency between approximately 15 kHz and approximately 60 kHz.

44. A system for analysis of bodily fluids comprising:

a first fluid passageway in fluid communication with a fluid source;

a valve operatively connected to the first fluid passageway, the valve being configured to separate an analysis portion from the fluid sample;

an analyzer configured to interact with the analysis portion to determine at least one analyte in the analysis portion of the fluid sample; and

an anti-clotting device configured to provide one or more anti-clotting agents to only the analysis portion.

45. The system of claim 44, further comprising a second fluid passageway in fluid communication with the first passageway, the second fluid passageway configured to receive the analysis portion.

46. The system of claim 45, wherein the anti-clotting device is operatively connected to the second fluid passageway.

47. The system of claim 45, wherein the anti-clotting device is fluidly coupled to the second fluid passageway.

48. The system of claim 44, further comprising a waste reservoir configured to collect the analysis portion of the fluid sample so that it is not returned to the fluid source.

49. The system of claim 44, wherein the analyzer is configured to determine the concentration of the at least one analyte in the analysis portion of the fluid sample.

50. The system of claim 44, further comprising a pump configured to draw a fluid sample into the first fluid passageway from the fluid source.