Disposable extracorporeal conduit for blood constituent monitoring

• US 5,351,686 A
• Filed: 05/24/1993
• Issued: 10/04/1994
• Est. Priority Date: 10/06/1990
• Status: Expired due to Term

• Current Assignee: Fresenius Medical Care Holdings Incorporated (Fresenius SE & Co. KGaA)
• Original Assignee: In-Line Diagnostics Corp.
• Inventors: Harris, David H., Steuer, Robert R.
• Primary Examiner(s): Sykes, Angela D.
• Application Number:
  US08/066,344
• Time in Patent Office: 498 Days
• Field of Search: 128/632-634, 128/637, 128/664-667, 128/673, 128/675, 128/748, 356/39-41
• US Class Current: 600/310
• 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 5/14557 specially adapted to extracorporeal circuits
• CPC Class Codes: A61B 5/6826 Finger
• CPC Class Codes: A61B 5/6838 Clamps or clips
• CPC Class Codes: A61B 5/6843 Monitoring or controlling sensor contact pressure
• CPC Class Codes: A61M 1/361 before treatment
• CPC Class Codes: A61M 1/3612 after treatment
• CPC Class Codes: G01N 2021/036 transformable, modifiable
• CPC Class Codes: G01N 21/0303 Optical path conditioning in cuvettes, e.g. windows; adapted optical elements or systems; path modifying or adjustment G01N21/031 - G01N21/15 take precedence

Abstract

A disposable cuvette through which to pass pulsatile flowing blood. The cuvette has a conduit with two opposed walls having a predetermined separation therebetween that varies with each pulse of the flowing blood. A sealed air pocket damps the variation of the predetermined separation. The conduit is comprised of materials which permit passage therethrough of wavelengths of selected electromagnetic radiation. The radiation is emitted from a photoemitter which, and after passing through the cuvette, is detected by a photodetector. The quantities of detected radiation are operated on by a computer which uses a spectrophotometry technique to derive therefrom a blood constituent concentration value. Preferably, both cuvette and spectrophotometry technique are used during hemodialysis to derive changes in the hematocrit value of the blood of a dialyzed patient, thereby to deduce therefrom changes in the blood volume of the patient during dialysis. The technique enables a clinician to monitor a desired biologic constituent concentration value, such as the hematocrit, oxygen saturation, or oxygen content values by deriving and displaying the same as digital values in real time.

Claims

1. A disposable fluid cuvette, defining a fluid passageway for containing and conducting therethrough a fluid flowing under pressure in a pulsatile fashion, comprising:

a. an inlet;

b. an outlet;

c. a conduit, in fluid communication both between and with said inlet and outlet and being comprised of materials which permit transmission of at least two predetermined wavelengths of electromagnetic radiation therethrough, comprising;

i. first and second opposed walls, having a predetermined separation therebetween, and constraining the pulsatile flowing fluid therebetween; and

ii. a transducer means, located in said first wall of said conduit, for varying said predetermined separation responsive to pressure pulsations in the fluid.

2. The cuvette as defined in claim 1, wherein said transducer means is comprised essentially of silicone and said second wall is comprised essentially of medical grade plastic.

3. The cuvette as defined in claim 2, wherein said first and second walls have an opposing facing side that is essentially circular in shape.

4. The cuvette as defined in claim 1, wherein the conduit further comprises means, responsive to pressure pulsations in the fluid, for damping the variations of the predetermined separation.

5. The cuvette as defined in claim 1, wherein said conduit further comprises a third wall, said first wall being disposed between said second and third walls, said third wall and said transducer means having a means, situated therebetween and responsive to pressure pulsations in the fluid, for damping the variations of the predetermined separation.

6. The cuvette as defined in claim 5, wherein said damping means is a hermetically sealed chamber.

7. The cuvette as defined in claim 5, wherein said first and second walls have an opposing facing side that is essentially circular in shape.

8. The cuvette as defined in claim 5, wherein said third wall has a convex side facing a side of said first wall.

9. The cuvette as defined in claim 8, wherein said second and third walls are essentially immobile with respect to said transducer means for each pulse of said pulsatile flowing blood.

10. The cuvette as defined in claim 9, wherein first wall is comprised essentially of silicone.

11. The cuvette as defined in claim 5, wherein said conduit means further comprises first, second and third cylindrical members in contact one with the others;

a. said first member being essentially comprised of silicone and comprising said first wall;

b. said second member being essentially comprised of medical grade plastic and comprising said second wall; and

c. said third member being essentially comprised of medical grade plastic and comprising said third wall.

12. The cuvette as defined in claim 11, wherein an external ring-shaped surface extends from said first and third walls.

13. The cuvette as defined in claim 1 wherein said at least two predetermined wavelengths of electromagnetic radiation comprise a first radiation wavelength of 780 nanometers to about 850 nanometers and a second radiation wavelength of about 1200 nanometers to about 1600 nanometers, and wherein said pulsatile flowing fluid is blood.

14. The cuvette as defined in claim 13 wherein said conduit is comprised of materials which permit transmission of electromagnetic radiation therethrough of a third radiation wavelength being of 900 nanometers to about 1000 nanometers, and of a fourth radiation wavelength being of 600 nanometers to about 700 nanometers.

15. The cuvette as defined in claim 1 wherein said at least two predetermined wavelengths of electromagnetic radiation comprise a first radiation wavelength of 520 nanometers to about 600 nanometers and a second radiation wavelength of about 1200 nanometers to about 1600 nanometers, and wherein said pulsatile flowing fluid is blood.

16. The cuvette as defined in claim 14 wherein said conduit is comprised of materials which permit transmission of electromagnetic radiation therethrough of a third radiation wavelength being of 900 nanometers to about 1000 nanometers, and of a fourth radiation wavelength being of 600 nanometers to about 700 nanometers.

17. The cuvette as defined in claim 1 wherein said transducer means is said first wall, and wherein for each pulse of said pulsatile flowing fluid, said first wall makes a resilient fluctuation and said second wall is essentially immobile.

18. The cuvette as defined in claim 1 wherein said conduit has an essentially cylindrical shape with a vertical wall both outside of and in between said first and second walls, said fluid flowing in a pulsatile fashion in contact with both said vertical wall and said first and second walls.

19. The cuvette as defined in claim 18 wherein the volume of said pulsatile flowing fluid in said conduit passing outside said first and second walls is greater than the volume of said pulsatile flowing fluid passing therebetween.

20. The cuvette as defined in claim 18 wherein said first and second walls are essentially parallel.

21. The cuvette as defined in claim 20 wherein said inlet and said outlet share a common longitudinal axis which is parallel to said first and second walls, and said cylindrical conduit has a longitudinal axis that is normal to the shared common longitudinal axis of said inlet and outlet.

22. The cuvette as defined in claim 1 further comprising:

a. means, extending from said first wall, for receiving a photoemitter; and

b. means, extending from said second wall, for receiving a photodetector.

23. The cuvette as defined in claim 1 further comprising external ring-shaped surfaces extending from said first and second walls.

24. The cuvette as defined in claim 1 wherein

a. said first wall has a first external ring-shaped surface extending therefrom;

b. said first external ring-shaped surface having a second external ring-shaped surface extending therefrom which is concentric to said first external ring-shaped surface; and

c. said first and second ring-shaped surfaces each having an inner diameter, said inner diameter of said first ring-shaped surface being less than said inner diameter of said second ring-shaped surface.

25. The cuvette as defined in claim 24 wherein said second wall has an external ring-shaped surface extending therefrom having an inner diameter that is greater than the inner diameter of said first ring-shaped surface.

26. The cuvette as defined in claim 25 wherein said external ring-shaped surface extending from said second wall is concentric with said first ring-shaped surface.

27. The cuvette as defined in claim 1 wherein said conduit cyclically increases and decreases the volume of pulsatile flowing fluid therein with each pulse of said pulsatile flowing fluid.

28. The cuvette as defined in claim 1 wherein each said inlet and said outlet further comprises a means for fixedly attaching thereat a catheter having a lumen therethrough in fluid communication with said conduit.

29. The cuvette as defined in claim 28 wherein said means for fixedly attaching is a luer lock connector.

30. A disposable blood cuvette, defining a fluid passageway for containing and conducting therethrough blood flowing under pressure in a pulsatile fashion, comprising:

a. an inlet;

b. an outlet;

c. a conduit, having an essentially cylindrical shape and being in fluid communication both between and with said inlet and outlet and being comprised of materials which permit transmission of at least two predetermined wavelengths of electromagnetic radiation therethrough, comprising;

i. opposed first and second walls, having a predetermined separation therebetween, and constraining the pulsatile flowing blood therebetween, and wherein for each pulse of said pulsatile flowing blood said first wall makes a resilient fluctuation so as to vary said predetermined separation and said second wall is essentially immobile; and

ii. a vertical wall, situated both outside and in between said first and second walls, said blood flowing in a pulsatile fashion in contact with both said vertical wall and said first and second walls.

31. The cuvette as defined in claim 30, wherein the conduit further comprises means for damping the resilient fluctuation of the first wall for each pulse of said pulsatile flowing blood.

32. The cuvette as defined in claim 30, wherein said conduit further comprises a third wall, said first wall being disposed between said second and third walls, said first and third walls having a means, situated therebetween, for damping the resilient fluctuation of the first wall for each pulse of said pulsatile flowing blood.

34. The cuvette as defined in claim 30, wherein the volume of said pulsatile flowing blood in said conduit passing outside said first and second walls is greater than the volume of said pulsatile flowing blood passing therebetween.

35. The cuvette as defined in claim 30 wherein:

a. said first wall has a first external ring-shaped surface extending therefrom;

b. said first external ring-shaped surface having a second external ring-shaped surface extending therefrom which is concentric to said first external ring-shaped surface; and

c. said first and second ring-shaped surfaces each having an inner diameter, said inner diameter of said first ring-shaped surface being less than said inner diameter of said second ring-shaped surface.

36. The cuvette as defined in claim 35 wherein said second wall has an external ring-shaped surface extending therefrom having an inner diameter that is greater than the inner diameter of said first ring-shaped surface.

37. The cuvette as defined in claim 36 wherein said external ring-shaped surface extending from said second wall is concentric with said first ring-shaped surface.

38. The cuvette as defined in claim 30 further comprising:

a. means, extending from said first wall, for receiving a photoemitter; and

b. means, extending from said second wall, for receiving a photodetector.

39. The cuvette as defined in claim 30 wherein said first and second walls are essentially parallel.

40. The cuvette as defined in claim 39 wherein said inlet and said outlet share a common longitudinal axis which is parallel to said first and second walls, and said cylindrical conduit has a longitudinal axis that is normal to the shared common longitudinal axis of said inlet and outlet.

41. The cuvette as defined in claim 30 further comprising external ring-shaped surfaces extending from said first and second walls.

42. The cuvette as defined in claim 30 wherein said conduit cyclically increases and decreases the volume of pulsatile flowing fluid therein with each pulse of said pulsatile flowing fluid.

33. The cuvette as defined in 32, wherein said conduit means further comprises first, second and third cylindrical members in contact one with the others;

a. said first member being essentially comprised of silicone and comprising said first wall;

b. said second member being essentially comprised of medical grade plastic and comprising said second and vertical walls;

c. said third member being essentially comprised of medical grade plastic and comprising said third wall.

43. A disposable fluid cuvette, for defining a fluid passageway for containing and conducting therethrough a fluid flowing in a pulsatile fashion, comprising:

a. a first fluid conduit, having an inlet and an outlet and a lumen therebetween;

b. a second fluid conduit, comprised at least in part of materials essentially permitting transmission of at least two predetermined wavelengths of electromagnetic radiation therethrough, and comprising;

i. an inlet in fluid communication with the outlet of the first fluid conduit;

ii. means, in contact with said pulsatile flowing fluid, for making a resilient fluctuation with each pulse of said pulsatile flowing fluid in a direction essentially normal to the general direction of movement of the pulsatile flowing fluid; and

iii. an outlet;

c. a third fluid conduit, having an inlet and an outlet and a lumen therebetween, said inlet of said third fluid conduit being in fluid communication with the outlet of the second fluid conduit.

44. The cuvette as defined in claim 43 wherein said second fluid conduit further comprises a cylinder having opposing closed first and second ends, said first end being said means for making a resilient fluctuation and said second end being immobile with each pulse of said pulsatile flowing fluid.

45. The cuvette as defined in claim 44 wherein said first and second ends are comprised of materials essentially permitting transmission therethrough of said at least two predetermined wavelengths of electromagnetic radiation.

46. The cuvette as defined in claim 44 wherein:

a. said first fluid conduit and said second fluid conduit have a common longitudinal axis; and

b. said cylinder has a longitudinal axis that is normal to the common longitudinal axis of said first and second fluid conduits.

47. The cuvette as defined in claim 44 wherein:

a. said first end has a first external ring-shaped surface extending therefrom;

b. said first external ring-shaped surface having a second external ring-shaped surface extending therefrom which is concentric to said first external ring-shaped surface; and

c. said first and second external ring-shaped surfaces each having an inner diameter, said inner diameter of said first external ring-shaped surface being less than said inner diameter of said second external ring-shaped surface.

48. The cuvette as defined in claim 47 wherein said second end has an external ring-shaped surface extending therefrom having an inner diameter that is greater than the inner diameter of said first external ring-shaped surface.

49. The cuvette as defined in claim 48 wherein said external ring-shaped surface extending from said second end is concentric with said first external ring-shaped surface.

50. The cuvette as defined in claim 44 wherein said cylinder further comprises a sidewall, situated both outside of and between said first and second ends, and wherein said pulsatile flowing fluid contacts said first and second ends and said sidewall of said cylinder.

51. The cuvette as defined in claim 50 wherein the volume of said pulsatile flowing fluid in said second fluid conduit passing outside said first and second ends is greater than the volume of said pulsatile flowing fluid passing therebetween.

52. The cuvette as defined in claim 43 wherein said second fluid conduit further comprises means, in contact with resilient fluctuation means, for damping the resilient fluctuation of said resilient fluctuation means with each pulse of said pulsatile flowing fluid.

53. The cuvette as defined in claim 43 wherein said second fluid conduit cyclically increases and decreases the volume of pulsatile flowing fluid therein with each pulse of said pulsatile flowing fluid.