Anti-clotting apparatus and methods for fluid handling system

• US 8,425,444 B2
• Filed: 04/11/2007
• Issued: 04/23/2013
• Est. Priority Date: 04/11/2006
• Status: Expired due to Fees

• Current Assignee: OptiScan Biomedical Corporation
• Original Assignee: OptiScan Biomedical Corporation
• Inventors: Keenan, Richard, Chiou, Jeff
• Primary Examiner(s): Hindenburg, Max
• Assistant Examiner(s): DANEGA, RENEE A
• Application Number:
  US11/734,242
• Publication Number:
  US 20070239096A1
• Time in Patent Office: 2,204 Days
• Field of Search: 604/4.01, 600/573
• US Class Current: 604/4.01
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: A61B 5/14557 specially adapted to extracorporeal circuits
• CPC Class Codes: A61M 1/152 Details related to the interface between cassette and machine
• CPC Class Codes: A61M 1/1524 the interface providing means for actuating on functional elements of the cassette, e.g. plungers
• CPC Class Codes: A61M 1/155 with treatment-fluid pumping means or components thereof
• CPC Class Codes: A61M 1/1566 Means for adding solutions or substances to the treating fluid
• CPC Class Codes: A61M 1/3672 Means preventing coagulation
• CPC Class Codes: A61M 2005/1404 Keep vein-open rate [KVO], i.e. low flow rate
• CPC Class Codes: A61M 2205/3306 Optical measuring means
• CPC Class Codes: A61M 2230/201 Glucose concentration
• CPC Class Codes: A61M 5/1723 using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00
• CPC Class Codes: G01N 29/00 Investigating or analysing materials by the use of ultrasonic, sonic or infrasonic waves; Visualisation of the interior of objects by transmitting ultrasonic or sonic waves through the object G01N3/00, G01N5/00, G01N7/00, G01N9/00, G01N11/00, G01N13/00, G01N15/00, G01N17/00, G01N19/00, G01N21/00, G01N22/00, G01N23/00, G01N24/00, G01N25/00, G01N27/00 take precedence

Abstract

Methods and apparatus are provided for determining the concentration of an analyte in a sample, such as an analyte in a sample of bodily fluid. In some embodiments, a method for maintaining clear passageways in an extracorporeal blood flow system includes intermittently providing one or more anti-clotting agents to a passageway of the extracorporeal blood flow system. In some embodiments, an extracorporeal blood flow system includes 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 maintaining clear passageways in a fluid flow system connected to a patient, the method comprising:

providing a passageway configured to carry a fluid flow in a fluid flow system from the patient;

drawing a fluid sample into the fluid flow system;

separating an analysis portion from the fluid sample;

providing one or more anti-clotting agents to only the analysis portion, wherein at least one of the anti-clotting agents comprises an anticoagulant;

preventing the analysis portion of the fluid sample from being returned to the patient; and

analyzing the analysis portion to determine at least one analyte measurement.

2. The method of claim 1, wherein providing one or more anti-clotting agents comprises intermittently providing ultrasonic energy to the passageway.

3. The method of claim 1, wherein providing one or more anti-clotting agents comprises delivering a cleaning solution that is thermally stable at room temperatures.

4. The method of claim 1, wherein providing one or more anti-clotting agents comprises delivering a mixture having approximately 1% TERGAZYME in saline.

5. The method of claim 1, wherein providing one or more anti-clotting agents comprises delivering a mixture comprising sodium heparin.

6. The method of claim 1, wherein providing one or more anti-clotting agents comprises delivering a mixture comprising K2EDTA.

7. The method of claim 1, wherein providing one or more anti-clotting agents comprises delivering a mixture comprising K3EDTA.

8. The method of claim 1, wherein providing one or more anti-clotting agents comprises delivering a mixture comprising potassium oxalate and sodium fluoride.

9. The method of claim 1, wherein providing one or more anti-clotting agents comprises delivering a mixture comprising sodium citrate and citric acid.

10. The method of claim 1, further comprising:

determining a ratio of volume of anticoagulant solution to total volume;

using the equation C0=C0′

(1+δ

V/V0) to correct for dilution; and

storing the corrected measurement in a memory.

11. The method of claim 10, further comprising:

providing an accurately-measured volume of anticoagulant solution; and

measuring the amount of anticoagulation analyte in the analysis portion.

12. The method of claim 1, wherein analyzing the analysis portion comprises analyzing the analysis portion for glucose concentration.

13. The method of claim 1, further comprising treating the fluid sample.

14. The method of claim 13, wherein treating comprises separating the fluid sample into fluid sample sub-components.

15. The method of claim 14, wherein separating the fluid sample into fluid sample sub-components comprises filtering the fluid sample.

16. The method of claim 14, wherein separating the fluid sample into fluid sample sub-components comprises centrifuging the fluid sample.

17. The method of claim 1, wherein providing one or more anti-clotting agents comprises introducing heparin into the analysis portion.

18. The method of claim 17, wherein introducing heparin comprises introducing a solution having a sodium heparin concentration of approximately 10 mg/dL.

19. The method of claim 1, wherein preventing the analysis portion of the analysis portion from being returned to the patient comprises directing the analysis portion into a waste reservoir.

20. A method for maintaining clear passageways in a fluid flow system connected to a patient, the method comprising:

providing a passageway configured to carry a fluid flow in a fluid flow system from the patient;

drawing a fluid sample into the fluid flow system;

providing one or more anti-clotting agents to at least a portion of the fluid sample, wherein at least one of the anti-clotting agents comprises an added anticoagulant; and

returning to the patient only one or more portions of the fluid sample, wherein the one or more portions include no added anticoagulant.

21. The method of claim 20, wherein providing one or more anti-clotting agents comprises delivering a mixture comprising sodium heparin.

22. The method of claim 20, wherein providing one or more anti-clotting agents comprises delivering a mixture comprising K2EDTA.

23. The method of claim 20, wherein providing one or more anti-clotting agents comprises delivering a mixture comprising K3EDTA.

24. The method of claim 20, wherein providing one or more anti-clotting agents comprises delivering a mixture comprising potassium oxalate and sodium fluoride.

25. The method of claim 20, wherein providing one or more anti-clotting agents comprises intermittently providing ultrasonic energy to the passageway.

26. The method of claim 20, wherein providing one or more anti-clotting agents comprises delivering a cleaning solution that is thermally stable at room temperatures.

27. The method of claim 20, wherein providing one or more anti-clotting agents comprises delivering a mixture having approximately 1% TERGAZYME in saline.

28. The method of claim 20, wherein providing one or more anti-clotting agents comprises delivering a mixture comprising sodium citrate and citric acid.

29. The method of claim 20, further comprising:

separating an analysis portion from the fluid sample; and

analyzing the analysis portion to determine at least one analyte measurement.

30. The method of claim 29, wherein analyzing the analysis portion comprises analyzing the analysis portion for glucose concentration.

31. The method of claim 29, further comprising:

determining a ratio of volume of anticoagulant solution to total volume;

using the equation C0=C0′

(1+δ

V/V0) to correct for dilution; and

storing the corrected measurement in a memory.

32. The method of claim 31, further comprising:

providing an accurately-measured volume of anticoagulant solution; and

measuring the amount of anticoagulation analyte in the analysis portion.

33. The method of claim 29, wherein providing one or more anti-clotting agents comprises introducing heparin into the analysis portion.

34. The method of claim 33, wherein introducing heparin comprises introducing a solution having a sodium heparin concentration of approximately 10 mg/dL.

35. The method of claim 20, further comprising treating the fluid sample.

36. The method of claim 35, wherein treating comprises separating the fluid sample into fluid sample sub-components.

37. The method of claim 36, wherein separating the fluid sample into fluid sample sub-components comprises filtering the fluid sample.

38. The method of claim 36, wherein separating the fluid sample into fluid sample sub-components comprises centrifuging the fluid sample.

39. The method of claim 20, wherein returning to the patient one or more portions of the fluid sample comprises pumping a volume of fluid sample back to the patient.