Methods and apparatus for extracting and analyzing a component of a bodily fluid

• US 20060189925A1
• Filed: 12/21/2005
• Published: 08/24/2006
• 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, Witte, Kenneth G.
• Application Number:
  US11/314,748
• Publication Number:
  US 20060189925A1
• Time in Patent Office: Days
• US Class Current: 604/66
• 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

In some embodiments, a system for bodily fluid sampling and analysis comprises a first fluid passageway having a patient end which is configured to provide fluid communication with a bodily fluid within a patient. A sample analysis chamber is accessible via the first fluid passageway. At least one pump is in operative engagement with the first fluid passageway such that the system is operable to periodically draw a sample of the bodily fluid from the patient through the first fluid passageway and toward the sample analysis chamber. A separator is accessible via the first fluid passageway and configured to remove at least one component from the sample of bodily fluid. A spectroscopic analyte detection system is configured to analyze the component of bodily fluid while the component of bodily fluid is in the sample analysis chamber, and determine a concentration of at least one analyte.

Claims

1. A system for bodily fluid sampling and analysis, said system comprising:

a first fluid passageway having a patient end which is configured to provide fluid communication with a bodily fluid within a patient;

a sample analysis chamber accessible via said first fluid passageway;

at least one pump in operative engagement with said first fluid passageway such that said system is operable to periodically draw a sample of said bodily fluid from said patient through said first fluid passageway and toward said sample analysis chamber;

a separator accessible via said first fluid passageway and configured to remove at least one component from said sample of bodily fluid; and

a spectroscopic analyte detection system configured to analyze said component of bodily fluid while said component of bodily fluid is in said sample analysis chamber, and determine a concentration of at least one analyte.

2. The system of claim 1, wherein:

said first fluid passageway further comprises an infusate end which is configured to provide fluid communication with an infusate source; and

said system is operable to deliver an infusate toward said patient through said first fluid passageway.

3. The system of claim 2, wherein the first fluid passageway further comprises a first connector at said infusate end for releasably connecting the first fluid passageway with an infusate source.

4. The system of claim 3, wherein the first fluid passageway further comprises a second connector at said patient end for releasably connecting said first fluid passageway with said bodily fluid of a patient.

5. The system of claim 4, wherein said second connector is configured to maintain a continuous connection with said bodily fluid of said patient.

6. The system of claim 4, wherein said second connector is configured to engage an IV tubing.

7. The system of claim 4, wherein said second connector is configured to engage a catheter.

8. The system of claim 1, wherein said first passageway further comprises one or more valves for selectively controlling fluid communication between said patient end and said sample analysis chamber.

9. The system of claim 1, wherein said sample analysis chamber is in fluid communication with said first fluid passageway.

10. The system of claim 1, wherein said at least one pump is directionally controllable.

11. The system of claim 1, wherein said at least one pump comprises two or more unidirectional pumps, wherein said unidirectional pumps are operatively configured to provide bi-directional flow through said first passageway.

12. The system of claim 1, further comprising a second fluid passageway connected to said first fluid passageway, wherein said second fluid passageway provides fluid communication between said first fluid passageway and said sample analysis chamber.

13. The system of claim 12 further comprising one or more valves for selectively controlling fluid communication between said first fluid passageway and said second fluid passageway.

14. The system of claim 13, wherein said at least one pump is further configured to move said sample of said bodily fluid from said patient through said first fluid passageway and said second passageway and toward said sample analysis chamber.

15. The system of claim 14, wherein said separator is in fluid communication with said second fluid passageway and said sample analysis chamber.

16. The system of claim 15, wherein said separator is a filter.

17. The system of claim 15, wherein said separator is a centrifuge.

18. The system of claim 1, wherein said sample analysis chamber is configured to receive at least a portion of said first component of a bodily fluid.

19. The system of claim 15, wherein said at least one pump comprises a first pump and a second pump, wherein said second pump is configured to draw said first component into said sample analysis chamber.

20. The system of claim 1, wherein sample analysis chamber comprises at least one window constructed from a material which allows electromagnetic radiation to pass into said sample analysis chamber.

21. The system of claim 1, wherein said sample analysis chamber comprises two windows positioned on opposing sides of said sample analysis chamber and constructed from a material which allows electromagnetic radiation to pass through said sample analysis chamber.

22. A system for periodically drawing a blood sample from a patient and analyzing the composition of at least one component of said blood sample, said system comprising:

a fluid passageway having a distal end which is configured to be inserted into the vasculature of a patient;

a sample analysis chamber in fluid communication with said fluid passageway;

an infusion fluid source in fluid communication with said fluid passageway, said source containing an infusion fluid;

a pump unit, said pump unit having a first mode in which said pump unit infuses said infusion fluid into said patient via said fluid passageway, and a second mode in which said pump unit is operable to draw a blood sample from said patient via said first fluid passageway and toward said sample analysis chamber;

a separator configured to remove at least one component from said blood sample before said sample is analyzed by said analyte detection system; and

a spectroscopic analyte detection system configured to analyze said at least one component while at least a portion of said at least one component is in said sample analysis chamber, and determine a concentration of at least one analyte.

23. The system of claim 22, wherein said distal end of said fluid passageway is configured to maintain fluid communication with said vasculature of a patient.

24. The system of claim 23, wherein said fluid passageway further comprises one or more branch passageways for establishing fluid communication with said sample analysis chamber.

25. The system of claim 24, further comprising one or more valves for selectively controlling fluid communication along said fluid passageway and among said vasculature of said patient, said infusion fluid source and said sample analysis chamber.

26. The system of claim 22, wherein said separator is configured to separate plasma from said blood sample.

27. The system of claim 26, wherein said separator is a filter.

28. The system of claim 26, wherein said separator is a centrifuge.

29. The system of claim 26, wherein said sample analysis chamber is configured to hold at least a portion of said plasma.

30. The system of claim 26, wherein said pump unit has a third mode in which said pump returns a portion of said drawn blood sample to said patient'"'"'s vasculature via said fluid passageway.

31. The system of claim 29, wherein said sample analysis chamber further comprises an interface for interfacing with said spectroscopic analyte detection system.

32. The system of claim 31, wherein said sample analysis chamber comprises at least one window constructed from a material which allows electromagnetic radiation to pass into said sample analysis chamber.

33. The system of claim 32, wherein said sample analysis chamber comprises two windows positioned on opposing sides of said sample analysis chamber and constructed from a material which allows electromagnetic radiation to pass through said sample analysis chamber.

34. The system of 33, wherein said pump unit comprises a first pump operable in said first mode and a second pump operable in said second mode.

35. A fluid handling and analysis system, said system comprising:

a fluid handling network comprising at least one fluid passageway, said fluid handling network including a patient end configured to maintain fluid communication with a bodily fluid in a patient;

a sample analysis chamber accessible via said fluid handling network;

a pump unit coupled to said fluid handling network, said pump unit having a sample draw mode in which said pump unit is operable to draw a sample of said bodily fluid from said patient through said patient end, toward said sample analysis chamber;

a spectroscopic fluid analyzer configured to analyze said sample of bodily fluid while said sample of bodily fluid is in said sample analysis chamber, and determine a concentration of at least one analyte; and

a separator configured to remove at least one component from said sample of bodily fluid before said sample is analyzed by said analyte detection system.

36. The system of claim 35, wherein said pump unit has an infusion mode in which said pump unit is operable to deliver infusion fluid to said patient through said patient end.

37. The system of claim 35, wherein said patient end is configured to engage an IV tubing.

38. The system of claim 35, wherein said patient end is configured to engage a catheter.

39. The system of claim 35, wherein said patient end is configured to maintain continuous fluid communication with a patient'"'"'s vasculature.

40. The system of claim 35, wherein said fluid handling network further comprises an infusion end configured to be connected to an infusion source.

41. The system of claim 36, wherein said system further comprises an infusion source in fluid communication with an infusion end of said fluid handling network, and said fluid handling network further comprises one or more branch fluid passageways which provide fluid communication between said first fluid passageway, said sample analysis chamber and said infusion source.

42. The system of claim 41, wherein said fluid handling network further comprises one or more valves for selectively controlling fluid communication among said patient end, said infusion end and said sample analysis chamber.

43. The system of claim 36, wherein said pump unit is directionally controllable for alternating between said infusion mode and said sample draw mode.

44. The system of claim 36, wherein said pump unit comprises a first pump operable in said infusion mode and a second pump operable in said sample draw mode.

45. The system of claim 35, wherein said separator is in fluid communication with said fluid handling network.

46. The system of claim 45, wherein said separator is in fluid communication with said sample analysis chamber.

47. The system of claim 35, wherein said separator is a filter.

48. The system of claim 35, wherein said separator is a centrifuge.

49. The system of claim 48, wherein said sample analysis chamber is located on said centrifuge.

50. The system of claim 35, wherein said sample analysis chamber is configured to hold at least a portion of said at least one component of said sample of bodily fluid.

51. The system of claim 35, wherein said sample analysis chamber comprises at least one window constructed of a material which allows electromagnetic radiation to pass into said sample analysis chamber.

52. The system of claim 35, wherein said sample analysis chamber comprises at least two windows positioned on opposing sides of said sample analysis chamber and constructed of a material which allows electromagnetic radiation to pass through said sample analysis chamber.

53. A method of extracting and analyzing a bodily fluid of a patient, said method comprising:

establishing fluid communication between a fluid transport network and a bodily fluid of a patient, wherein said fluid transport network further comprises at least one fluid passageway and a fluid component separator;

drawing a volume of bodily fluid from said patient into said fluid transport network;

transporting said volume of bodily fluid to said fluid component separator via said at least one fluid passageway;

with said fluid component separator, separating a first component from said bodily fluid;

transporting said first component to a sample analysis chamber, wherein said sample analysis chamber is operatively engaged with an analyte detection system; and

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

54. The method of claim 53, wherein establishing fluid communication comprises placing said patient'"'"'s vasculature in fluid communication with a first fluid passageway in said fluid transport network.

55. The method of claim 54, further comprising maintaining fluid communication between said patient'"'"'s vasculature and said first fluid passageway.

56. The method of claim 55, further comprising:

connecting said fluid transport network to an infusion source containing an infusion liquid; and

periodically infusing said patient'"'"'s vasculature with said liquid via said first passageway.

57. The method of claim 56, wherein said periodically infusing comprises transporting said infusion liquid to said patient'"'"'s vasculature via said first passageway.

58. The method of claim 57, wherein said fluid transport network comprises at least one pump and transporting said infusion liquid comprises pumping said infusion liquid through said first passageway toward said patient'"'"'s vasculature.

59. The method of claim 56, further comprising alternately drawing a volume of bodily fluid from said patient'"'"'s vasculature and infusing said patient'"'"'s vasculature with an infusion liquid.

60. The method of claim 59, wherein alternately drawing and delivering comprises selectively controlling fluid communication between said first fluid passageway and said infusion source and said bodily fluid of said patient.

61. The method of claim 60, wherein alternately drawing and delivering comprises alternately reversing the direction of flow in said first passageway.