Method of extracting and analyzing the composition of bodily fluids

• US 20060235348A1
• Filed: 12/21/2005
• Published: 10/19/2006
• Est. Priority Date: 02/14/2005
• Status: Abandoned Application

• Current Assignee: OptiScan Biomedical Corporation
• Original Assignee: OptiScan Biomedical Corporation
• Inventors: Gable, Jennifer H., Braig, James R., Zheng, Peng, Wechsler, Mark, Keenan, Richard, Rule, Peter, King, Richard A., Callicoat, David N., Witte, Kenneth G.
• Application Number:
  US11/314,964
• Publication Number:
  US 20060235348A1
• Time in Patent Office: Days
• US Class Current: 604/4.10
• CPC Class Codes: A61B 10/0064 for taking sweat or sebum samples measuring sweat production A61B5/4266
• CPC Class Codes: A61B 2560/0443 Modular apparatus
• CPC Class Codes: A61B 5/0071 by measuring fluorescence emission
• CPC Class Codes: A61B 5/0075 by spectroscopy, i.e. measuring spectra, e.g. Raman spectroscopy, infrared absorption spectroscopy A61B5/0071 takes precedence
• CPC Class Codes: A61B 5/0084 for introduction into the body, e.g. by catheters A61B5/1459 takes precedence
• CPC Class Codes: A61B 5/0086 using infrared radiation
• CPC Class Codes: A61B 5/1411 by percutaneous method, e.g. by lancet
• CPC Class Codes: A61B 5/1427 Multiple blood sampling, e.g. at periodic or pre-established intervals
• CPC Class Codes: A61B 5/1451 for interstitial fluid
• CPC Class Codes: A61B 5/14517 for sweat
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14535 for measuring haematocrit
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: A61B 5/1455 using optical sensors, e.g. spectral photometrical oximeters
• 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 5/150267 Modular design or construction, i.e. subunits are assembled separately before being joined together or the device comprises interchangeable or detachable modules
• CPC Class Codes: A61B 5/150358 Strips for collecting blood, e.g. absorbent optical reagent test strips G01N21/8483; chemical reagent test strips G01N33/4875, G01N33/52
• 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: A61B 5/4839 : combined with drug delivery
• CPC Class Codes: A61M 2205/12 : with interchangeable cassettes forming partially or totally the fluid circuit
• CPC Class Codes: A61M 2205/3306 : Optical measuring means
• CPC Class Codes: A61M 2230/20 : Blood composition characteristics
• CPC Class Codes: A61M 2230/201 : Glucose concentration
• CPC Class Codes: A61M 5/14212 : Pumping with an aspiration and an expulsion action
• CPC Class Codes: A61M 5/14232 : Roller pumps
• CPC Class Codes: A61M 5/16854 : by monitoring line pressure
• 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: A61M 5/365 : Air detectors A61M5/1684 takes precedence; in extracorporeal blood circuits A61M1/3626
• CPC Class Codes: A61M 5/38 : using hydrophilic or hydrophobic filters
• CPC Class Codes: G01N 2021/3595 : using FTIR
• CPC Class Codes: G01N 21/03 : Cuvette constructions
• CPC Class Codes: G01N 21/3577 : for analysing liquids, e.g. polluted water
• CPC Class Codes: G01N 2201/02 : Mechanical
• CPC Class Codes: G01N 2201/061 : Sources
• CPC Class Codes: Y10T 137/4478 : Line condition change responsive
• CPC Class Codes: Y10T 137/7722 : Line condition change responsive valves
• CPC Class Codes: Y10T 137/86485 : Line condition change responsive release of valve
• CPC Class Codes: Y10T 436/111666 : Utilizing a centrifuge or compartmented rotor
• CPC Class Codes: Y10T 436/2575 : Volumetric liquid transfer

Abstract

A method of extracting and analyzing bodily fluids from a patient at the point of care for the patient is provided. The method comprises establishing fluid communication between an analyte detection system and a bodily fluid in the patient. A portion of the bodily fluid is drawn from the patient. The drawn portion is separated into a first component of the bodily fluid, while the analyte detection system remains in fluid communication with the patient. The analyte detection system analyzes the first component to measure a concentration of an analyte.

Claims

1. A method of extracting and analyzing bodily fluids from a patient at the point of care for said patient comprising:

establishing fluid communication between an analyte detection system and a bodily fluid in said patient;

drawing from said patient a portion of said bodily fluid;

separating from said drawn portion a first component of said bodily fluid, while said analyte detection system remains in fluid communication with said patient; and

with said analyte detection system, analyzing said first component to measure a concentration of an analyte.

2. The method of claim 1, wherein establishing fluid communication comprises placing said patient in communication with at least one fluid passageway of said analyte detection system.

3. The method of claim 2, wherein establishing fluid communication comprises operably connecting said analyte detection system to said patient via IV tubing.

4. The method of claim 2, wherein establishing fluid communication comprises operably connecting said analyte detection system to said patient via a catheter.

5. The method of claim 2, wherein establishing fluid communication comprises placing said patient'"'"'s vasculature in fluid communication with at least one fluid passageway of said analyte detection system.

6. The method of claim 1, further comprising placing said analyte detection system in fluid communication with an infusion liquid source.

7. The method of claim 6, further comprising periodically infusing said patient'"'"'s vasculature with a liquid from said infusion liquid source.

8. The method of claim 7, wherein the infusion liquid is selected from a group consisting of saline, lactated ringer'"'"'s solution and water.

9. The method of claim 7, wherein the infusion liquid is delivered at a rate ranging from about 1-5 ml/hr.

10. The method of claim 7, wherein further comprising the step of alternating between said drawing and infusing.

11. The method of claim 1, wherein said separating comprises using centrifugal force to remove a first component from said drawn portion of bodily fluid.

12. The method of claim 1, wherein said separating comprises filtering said first component from said drawn portion of bodily fluid.

13. The method of claim 1, wherein said first component of said drawn portion of bodily fluid has a different composition from a remainder of said drawn portion of bodily fluid.

14. The method of claim 1, wherein said separating occurs immediately after said drawing step.

15. The method of claim 14, wherein said separating occurs less than 2 minutes after said drawing step.

16. The method of claim 15, wherein said separating occurs less than 5 minutes after said drawing step.

17. The method of claim 1, further comprising periodically repeating said drawing, separating, and analyzing.

18. The method of claim 17, further comprising storing the resulting measurements of the concentration of said analyte.

19. The method of claim 18, further comprising the step of displaying the measured concentrations of said analyte on a display device at the patient'"'"'s bedside.

20. The method of claim 17, further comprising the step of generating an audible alarm if the concentrations of an analyte fall outside of a predetermined range.

21. The method of claim 1, wherein establisihing fluid communication comprises connecting the analyte detection system to only one patient.

22. The method of claim 21, further comprising locating said analyte detection system at said patient'"'"'s bedside.

23. A method of preparing for analysis a bodily fluid of a patient, said method comprising:

operably connecting a fluid separation system to said patient;

drawing a portion of said bodily fluid from said patient and into said fluid separation system; and

separating a first component from said drawn portion of bodily fluid with said fluid separation system, while said fluid separation system remains operably connected to said patient.

24. The method of claim 23, wherein operably connecting comprises operably connecting said fluid separation system to said patient via IV tubing.

25. The method of claim 23, wherein operably connecting comprises placing the fluid separation system in fluid communication with said patient.

26. The method of claim 23, wherein said fluid separation system comprises at least one fluid passageway and said wherein operably connecting step further comprises placing said patient in communication with at least one fluid passageway in said fluid separation system.

27. The method of claim 23, wherein said fluid separation system comprises a centrifuge and said separating comprises using centrifugal force to remove said first component from said drawn portion of bodily fluid.

28. The method of claim 23, wherein said fluid separation system comprises a filter and said separating step further comprises filtering said first component from said drawn portion of bodily fluid.

29. The method of claim 23, wherein said first component of said drawn portion of bodily fluid has a different composition from a remainder of said drawn portion of bodily fluid.

30. The method of claim 29, wherein said separating occurs immediately after said drawing step.

31. The method of claim 29, wherein said separating occurs less than 2 minutes after said drawing step.

32. The method of claim 29, wherein said separating occurs less than 5 minutes after said drawing step.

33. The method of claim 29, wherein said bodily fluid drawn from said patient is blood.

34. The method of claim 33, wherein said first component separated from the drawn portion of blood is plasma.

35. The method of claim 34, wherein said separating step occurs before said drawn blood begins to clot.

36. The method of claim 23, further comprising the step of returning a remainder portion of said drawn bodily fluid to said patient.

37. The method of claim 29, further comprising the step of analyzing said first component of said bodily fluid with an analyte detection system to determine a concentration of an analyte.

38. The method of claim 37, wherein said analyte detection system is operably connected to said fluid separation system.

39. The method of claim 38, wherein said fluid separation system is housed within said analyte detection system.

40. A method of extracting and analyzing a bodily fluid of a patient, said method comprising the steps of:

attaching an analyte detection system to a patient wherein said analyte detection system further comprises a fluid handling system;

attaching said fluid handling system to said patient;

drawing a sample of bodily fluid from said patient into said fluid handling system; and

directly analyzing said sample with said analyte detection system to measure a concentration of an analyte.

41. The method of claim 40, wherein said attaching comprises connecting said analyte detection system to only said patient.

42. The method of claim 41, further comprising locating said analyte detection system at said patient'"'"'s bedside.

43. The method of claim 40, wherein said attaching comprises placing said patient in communication with at least one fluid passageway in said fluid handling system.

44. The method of claim 40, wherein said attaching comprises operably connecting said fluid handling system to said patient via IV tubing.

45. The method of claim 40, wherein said attaching comprises operably connecting said fluid handling system to said patient via a catheter.

46. The method of claim 40, wherein said attaching comprises placing said patient'"'"'s vasculature in fluid communication with at least one fluid passageway in said fluid handling system.

47. The method of claim 46, further comprising the steps of:

attaching an infusion liquid source to said fluid handling system; and

infusing said patient'"'"'s vasculature with an infusion liquid from said source.

48. The method of claim 40, wherein the fluid handling system further comprises a fluid separation system, further comprising the step of separating a first component from said sample of bodily fluid;

and wherein the analyzing step further comprises the step of directly analyzing said first component of said sample to measure a concentration of an analyte.

49. The method of claim 48, wherein said fluid separation system further comprises a centrifuge and said separating step further comprises using centrifugal force to separate said first component from said drawn sample of bodily fluid.

50. The method of claim 48, wherein said fluid separation system comprises a filter and said separating step further comprises filtering a first component from said drawn portion of bodily fluid.

51. The method of claim 48, wherein said separating occurs immediately after said drawing step.

52. The method of claim 48, wherein said separating occurs less than 2 minutes after said drawing step.

53. The method of claim 48, wherein said separating occurs less than 5 minutes after said drawing step.

54. The method of claim 48, wherein said bodily fluid drawn from said patient is blood.

55. The method of claim 48, wherein said first component separated from the drawn sample of blood is plasma.

56. The method of claim 55, wherein said separating step occurs before said drawn blood begins to clot.