Automated non-invasive real-time acute renal failure detection system

• US 20060100743A1
• Filed: 04/22/2005
• Published: 05/11/2006
• Est. Priority Date: 04/23/2004
• Status: Abandoned Application

• Current Assignee: Renal Diagnostic Incorporated
• Original Assignee: Renal Diagnostic Incorporated
• Inventors: Boyer, Richard, Star, Robert, Komanski, Christopher, Fine, Derek, Townsend, Seth, Tedford, Nathan
• Application Number:
  US11/113,212
• Publication Number:
  US 20060100743A1
• Time in Patent Office: Days
• US Class Current: 700/266
• CPC Class Codes: A61B 5/14507 specially adapted for measuring characteristics of body fluids other than blood devices for taking samples of body liquids A61B10/0045
• CPC Class Codes: A61B 5/201 Assessing renal or kidney functions
• CPC Class Codes: A61B 5/208 adapted to determine urine quantity, e.g. flow, volume
• CPC Class Codes: A61B 5/412 Detecting or monitoring sepsis

Abstract

A real-time, non-invasive system and method for determining the level of an analyte of interest in the urine of a patient is disclosed. The system and method uses the measured level of an analyte of interest to detect the onset of acute renal failure (ARF) as early as possible to prevent that patient from developing the disease or mitigating the effects of the disease. The system and method may be used to monitor the recovery of a patient after an ARF diagnosis. Preferably, the analyte of interest is creatinine or urea. The system may be placed in the urine drain line of a patient between a Foley catheter or other urinary drain and a urine collection bag. The system makes substantially continuous measurements of the urine flow rate and the concentration of the analyte of interest to determine the mass excretion rate of the analyte so it may be monitored to detect if the patient experiences a delta change in the mass excretion rate of an analyte that is indicative of the onset of ARF or a change in renal function.

Claims

1. A computer-based system for determining a flow rate of a liquid stream in substantially real-time, comprising:

(a) a vessel that will permit the liquid stream to fill the vessel at a natural flow rate of the liquid stream;

(b) a liquid stream control system under computer control for controlling filling and draining the vessel, with the liquid stream control stream controlling filling the vessel at the natural flow rate of the liquid stream;

(c) a first trigger mechanism disposed adjacent to the vessel, with the first trigger mechanism being activated when a level of the liquid filling the vessel is at a predetermined location with respect to the first trigger mechanism;

(d) a second trigger mechanism disposed adjacent to the vessel at a location different from the first trigger mechanism, with the second trigger mechanism being activated at a time after the first trigger mechanism is activated when the level of the liquid filling the vessel is at a predetermined location with respect the second trigger mechanism;

(e) a timer associated with the first and second trigger mechanisms for generating a timing signal indicative of the time interval between when the first trigger mechanism is activated and the second trigger mechanism is activated;

(f) a volume determining means for determining a volume of the vessel that was filled in the time interval between when the first trigger mechanism is activated and the second trigger mechanism is activated; and

(g) the computer for receiving the signal generated by the timer and volume from the volume determining means, and generating a flow rate for the liquid stream based on the signal generated by the timer and the volume from the volume determining means.

2. The system as recited in claim 1, wherein the vessel includes an elongated tubular member.

3. The system as recited in claim 1, wherein the liquid stream control system includes valve means for controlling filling and draining the vessel.

4. The system as recited in claim 3, wherein the valve means include a first pinch valve associated with an input section of the vessel for controlling filling the vessel and a second pinch valve associated with an output section of the vessel for controlling draining the vessel.

5. The system as recited in claim 1, wherein the first trigger mechanism includes a laser diode (“

LD”

)/photodiode pair or a light emitting diode (“

LED”

)/photodiode pair.

6. The system as recited in claim 1, wherein the second trigger mechanism includes a laser diode (“

LD”

)/photodiode pair or a light emitting diode (“

LED”

)/photodiode pair.

7. The system as recited in claim 1, wherein the liquid stream control system includes a controllable pumping means for controlling filling and draining the vessel.

8. The system as recited in claim 1, wherein the computer determines the flow rate according the expression:

$\mathrm{FR}=\frac{\mathrm{Volume}}{\mathrm{Time}}$

Where,

FR=Flow rate of liquid stream

Volume=Volume from volume determining means

Time=Time value from timer.

9. A computer-based system for determining a flow rate of a liquid stream in substantially real-time, comprising:

(a) a vessel that will permit the liquid stream to fill the vessel at a natural flow rate of the liquid stream;

(b) a liquid stream control system under computer control for controlling filling and draining the vessel, with the liquid stream control stream controlling the filling the vessel at the natural flow rate of the liquid stream;

(c) a first trigger mechanism disposed adjacent to the vessel, with the first trigger mechanism being activated when a level of the liquid filling the vessel is at a predetermined location with respect to the first trigger mechanism;

(d) N trigger mechanisms disposed adjacent to the vessel at locations different from the first trigger mechanism and different from each other, with N≧

1, and with the each of the N trigger mechanisms being activated at a time after the first trigger mechanism is activated when the level of the liquid filling the vessel is at a predetermined location with respect to each of the N trigger mechanisms;

(e) a timer associated with the first and N trigger mechanisms for generating a timing signal indicative of the time interval between when the first trigger mechanism and when any selected one of the N trigger mechanisms is activated;

(f) a volume determining means for determining a volume of the vessel that was filled in the time interval between when the first trigger mechanism is activated and when the selected one of the N trigger mechanisms is activated; and

(g) the computer for receiving the signal generated by the timer and volume from the volume determining means, and generating a flow rate for the liquid stream based on the signal generated by the timer and the volume from the volume determining means.

10. The system as recited in claim 9, wherein the vessel includes an elongated tubular member.

11. The system as recited in claim 9, wherein the liquid stream control system includes valve means for controlling the filling and draining of the vessel.

12. The system as recited in claim 11, wherein the valve means include a first pinch valve associated with an input section of the vessel for controlling filling the vessel and a second pinch valve associated with an output section of the vessel for controlling draining the vessel.

13. The system as recited in claim 9, wherein the first trigger mechanism includes a laser diode (“

LD”

)/photodiode pair or a light emitting diode (“

LED”

)/photodiode pair.

14. The system as recited in claim 9, wherein the second trigger mechanism includes a laser diode (“

LD”

)/photodiode pair or a light emitting diode (“

LED”

)/photodiode pair.

15. The system as recited in claim 9, wherein the liquid stream control system includes a controllable pumping means for controlling filling and draining the vessel.

16. The system as recited in claim 9, wherein the computer determines the flow rate according the expression:

$\mathrm{FR}=\frac{\mathrm{Volume}}{\mathrm{Time}}$

Where,

FR=Flow rate of liquid stream

Volume=Volume from volume determining means

Time=Time value from timer.

17. A computer-based method for substantially continuously determining a flow rate of a liquid stream in substantially real-time, comprising the steps of:

(a) controlling with liquid stream control means for filling and draining a vessel with liquid from the liquid stream;

(b) setting the liquid stream control means for filling the vessel with liquid at a natural flow rate of the liquid stream;

(c) activating a first trigger means when a level of the liquid filling the vessel is at a predetermined location with respect to the first trigger means;

(d) activating a second trigger means at a time after the activation of the first trigger means when the level of the liquid filling the vessel is at a predetermined location with respect to the second trigger means;

(e) measuring with timer means the time interval between when the first trigger means is activated and the second trigger means is activated;

(f) determining with volume determining means a volume of the vessel that was filled in the time interval between when the first trigger means is activated and the second trigger means is activated;

(g) determining the flow rate of the liquid stream based on the time measured at step (e) and the volume determined at step (f);

(h) setting the liquid stream control means for draining the vessel; and

(i) repeating steps (b) to (h) for substantially continuously determining the flow rate of the liquid stream.

18. The method as recited in claim 17, wherein step (g) determines the flow rate according to the expression:

$\mathrm{FR}=\frac{\mathrm{Volume}}{\mathrm{Time}}$

Where,

FR=Flow rate of liquid stream

Volume=Volume from step (f)

Time=Time from step (e).

19. The method as recited in claim 18, wherein the method further includes the step tracking the determinations of flow rate as a function of time for predetermined time period.

20. A computer-based method for substantially continuously determining a flow rate of a liquid stream in substantially real-time, comprising the steps of:

(a) controlling with liquid stream control means filling and draining a vessel with liquid from the liquid stream;

(b) setting the liquid stream control means for filling the vessel with liquid at a natural flow rate of the liquid stream;

(c) activating a first trigger means when a level of the liquid filling the vessel is at a predetermined location with respect to the first trigger means;

(d) activating a selected one of N trigger means at a time after the activation of the first trigger means when a level of the liquid filling the vessel is at a predetermined location with respect to the selected one of N trigger means, with N≧

1;

(e) measuring with timer means the time interval between when the first trigger means is activated and when the selected one of N second trigger means is activated;

(f) determining with volume determining means a volume of the vessel that was filled in the time interval between when the first trigger means is activated and when the selected one of N trigger means is activated;

(g) determining the flow rate of the liquid stream based on the time measured at step (e) and the volume determined at step (f);

(h) setting the liquid stream control means for draining the vessel; and

(i) repeating steps (b) to (h) for substantially continuously determining the flow rate of the liquid stream.

21. The method as recited in claim 20, wherein step (g) determines the flow rate according to the expression:

$\mathrm{FR}=\frac{\mathrm{Volume}}{\mathrm{Time}}$

Where,

FR=Flow rate of liquid stream

Volume=Volume from step (f)

Time=Time from step (e).

22. The method as recited in claim 21, wherein the method further includes the step of tracking the determinations of flow rate as a function of time for a predetermined time period.

23. A computer-based system for determining and monitoring a change in a level of a constituent in a liquid stream in substantially real-time to indicate an onset of a condition indicative of such change, comprising:

(a) a first subsystem for substantially continuously determining a flow rate of the liquid stream according to the expression;

$\mathrm{FR}=\frac{\mathrm{Volume}}{\mathrm{Time}}$

Where,

FR=Flow rate of liquid stream

Volume=Volume filled at a natural flow rate of the liquid stream according to the “

Time”

Time=Time to fill “

Volume;

”

(b) a second subsystem for substantially continuously determining a concentration of the constituent in the liquid stream;

(c) the computer for substantially continuously determining a mass excretion rate for the constituent in the liquid stream according to the expression;

$\begin{array}{c}\mathrm{ME}=\left(\mathrm{FR}\right)<br><br>\left(\mathrm{Concentration}\right)\\ \mathrm{ME}=\left(\frac{\mathrm{Volume}}{\mathrm{Time}}\right)<br><br>\left(\frac{\mathrm{Mass}}{\mathrm{Volume}}\right)=\left(\frac{\mathrm{Mass}}{\mathrm{Time}}\right)\end{array}$

Where,

ME=Mass excretion rate of constituent

FR=Flow rate of liquid stream

Volume=Volume filled at a natural flow rate of the liquid stream according to “

Time”

Time=Time to fill “

Volume”

Mass=Measured mass of constituent in liquid/Volume; and

(d) monitoring means for substantially continuously monitoring the mass excretion rate of the constituent in the liquid stream for changes indicative an onset of the condition indicative of such change.

24. The system as recited in claim 23, wherein the first subsystem for substantially continuously determining the flow rate of the liquid stream, further comprises,

(1) a vessel that will permit the liquid stream to fill the vessel at a natural flow rate of the liquid stream,

(2) a liquid stream control system under computer control for controlling filling and draining the vessel, with the liquid stream control stream controlling filling the vessel at the natural flow rate of the liquid stream,

(3) a first trigger mechanism disposed adjacent to the vessel, with the first trigger mechanism being activated when a level of the liquid filling the vessel is at a predetermined location with respect to the first trigger mechanism,

(4) a second trigger mechanism disposed adjacent to the vessel at a location different from the first trigger mechanism, with the second trigger mechanism being activated at a time after the first trigger mechanism is activated when the level of the liquid filling the vessel is at a predetermined location with respect the second trigger mechanism,

(5) a timer associated with the first and second trigger mechanisms for generating a timing signal indicative of the time interval between when the first trigger mechanism is activated and the second trigger mechanism is activated,

(6) a volume determining means for determining a volume of the vessel that was filled in the time interval between when the first trigger mechanism is activated and the second trigger mechanism is activated, and

(7) the computer receives the signal generated by the timer and volume from the volume determining means, and generates a flow rate for the liquid stream based on the signal generated by the timer and the volume from the volume determining means.

25. The system as recited in claim 24, wherein the vessel includes an elongated tubular member.

26. The system as recited in claim 24, wherein the liquid stream control system includes valve means for controlling filling and draining the vessel.

27. The system as recited in claim 26, wherein the valve means include a first pinch valve associated with an input section of the vessel for controlling filling the vessel and a second pinch valve associated with an output section of the vessel for controlling draining the vessel.

28. The system as recited in claim 24, wherein the first trigger mechanism includes a laser diode (“

LD”

)/photodiode pair or a light emitting diode (“

LED”

)/photodiode pair.

29. The system as recited in claim 24, wherein the second trigger mechanism includes a laser diode (“

LD”

)/photodiode pair or a light emitting diode (“

LED”

)/photodiode pair.

30. The system as recited in claim 24, wherein the liquid stream control system includes a controllable pumping means for controlling filling and draining the vessel.

31. The system as recited in claim 23, wherein the first subsystem for substantially continuously determining the flow rate of the liquid stream, further comprises,

(1) a vessel that will permit the liquid stream to fill the vessel at a natural flow rate of the liquid stream,

(2) a liquid stream control system under computer control for controlling filling and draining the vessel, with the liquid stream control stream controlling filling the vessel at the natural flow rate of the liquid stream,

(3) a first trigger mechanism under computer control disposed adjacent to the vessel, with the first trigger mechanism being activated when a level of the liquid filling the vessel is at a predetermined location with respect to the. first trigger mechanism,

(4) N trigger mechanisms under disposed adjacent to the vessel at locations different from the first trigger mechanism and different from each other, with N≧

1, and with the each of the N trigger mechanisms being activated at a time after the first trigger mechanism is activated when the level of the liquid filling the vessel is at a predetermined location with respect to each of the N trigger mechanisms,

(5) a timer associated with the first and N trigger mechanisms for generating a timing signal indicative of the time interval between when the first trigger mechanism and when any selected one of the N trigger mechanisms is activated,

(6) a volume determining means for determining a volume of the vessel that was filled in the time interval between when the first trigger mechanism is activated and when the selected one of the N trigger mechanisms is activated, and

(7) the computer for receiving the signal generated by the timer and volume from the volume determining means, and generating a flow rate for the liquid stream based on the signal generated by the timer and the volume from the volume determining means.

32. The system as recited in claim 31, wherein the vessel includes an elongated tubular member.

33. The system as recited in claim 31, wherein the liquid stream control system includes valve means for controlling the filling and draining of the vessel.

34. The system as recited in claim 33, wherein the valve means include a first pinch valve associated with an input section of the vessel for controlling filling the vessel and a second pinch valve associated with an output section of the vessel for controlling draining the vessel.

35. The system as recited in claim 31, wherein the first trigger mechanism includes a laser diode (“

LD”

)/photodiode pair or a light emitting diode (“

LED”

)/photodiode pair.

36. The system as recited in claim 31, wherein the second trigger mechanism includes a laser diode (“

LD”

)/photodiode pair or a light emitting diode (“

LED”

)/photodiode pair.

37. The system as recited in claim 31, wherein the liquid stream control system includes a controllable pumping means for controlling filling and draining the vessel.

38. The system as recited in claim 23, wherein the second subsystem for determining the concentration of the constituent in the liquid stream, further comprises,

(1) an energy source that is capable of being controlled to excite the constituent in the liquid stream to produce a spectral response in a known frequency band when such constituent is exposed to the energy source;

(2) a spectrometer that is capable of being controlled to detect the spectral response produced by the constituent when exposed to the energy source; and

(3) the computer being capable of processing the spectral response detected by the spectrometer to generate a measurement of a concentration of constituent in the liquid stream.

39. The system as recited in claim 38, wherein the energy source includes a Raman laser.

40. The system as recited in claim 38, wherein the spectrometer includes a Raman spectrometer.

41. The system as recited in claim 23, wherein the monitor means includes a graphical display for displaying the mass excretion rate of the constituent.

42. The system as recited in claim 23, wherein the monitor means includes a graphical display for displaying the flow rate of the liquid stream.

43. The system as recited in claim 23, wherein the monitor means includes a video display for displaying the mass excretion rate of the constituent.

44. The system as recited in claim 23, wherein the system further includes an alarm that may be activated if there is a change in the mass excretion rate of the constituent in the liquid stream indicative of the onset of the condition indicative of such change.

45. The system as recited in claim 23, wherein the liquid stream includes a urine stream.

46. The system as recited in claim 45, wherein the constituent includes creatinine.

47. The system as recited in claim 45, wherein the constituent includes urea.

67. The system as recited in claim 23, wherein the vessel includes being disposable.

68. The system as recited in claim 23, wherein the monitor means includes a video display for displaying the flow rate of the liquid stream.

69. The system as recited in claim 23, wherein the system further includes an alarm that may be activated if there is a change in the flow rate of the liquid stream indicative of the onset of the condition indicative of such change.

48. A computer-based method for determining and monitoring a change in a level of a constituent in a liquid stream in substantially real-time to indicate an onset of a condition indicative of such change, comprising:

(a) substantially continuously determining a flow rate of the liquid stream according to the expression;

$\mathrm{FR}=\frac{\mathrm{Volume}}{\mathrm{Time}}$

Where,

FR=Flow rate of liquid stream

Volume=Volume filled at a natural flow rate of the liquid stream according to the “

Time”

Time=Time to fill “

Volume;

”

(b) substantially continuously determining a concentration of the constituent in the liquid stream;

(c) substantially continuously determining a mass excretion rate for the constituent in the liquid stream according to the expression;

$\begin{array}{c}\mathrm{ME}=\left(\mathrm{FR}\right)<br><br>\left(\mathrm{Concentration}\right)\\ \mathrm{ME}=\left(\frac{\mathrm{Volume}}{\mathrm{Time}}\right)<br><br>\left(\frac{\mathrm{Mass}}{\mathrm{Volume}}\right)=\left(\frac{\mathrm{Mass}}{\mathrm{Time}}\right)\end{array}$

Where,

ME=Mass excretion rate of constituent

FR=Flow rate of liquid stream

Volume=Volume filled at a natural flow rate of the liquid stream according to “

Time”

Time=Time to fill “

Volume”

Mass=Measured mass of constituent in liquid/Volume; and

(d) substantially continuously monitoring the mass excretion rate of the constituent in the liquid stream for a change indicative of the onset of the condition indicative of such change.

49. The method as recited in claim 48, wherein the step of substantially continuously determining the flow rate of the liquid stream, further comprises the substeps of,

(1) controlling with liquid stream control means for filling and draining a vessel with liquid from the liquid stream,

(2) setting the liquid stream control means for filling the vessel with liquid from the liquid stream at a natural flow rate of the liquid stream,

(3) activating a first trigger means when a level of the liquid filling the vessel is at a predetermined location with respect to the first trigger means,

(4) activating a second trigger means at a time after the activation of the first trigger means when the level of the liquid filling the vessel is at a predetermined location with respect to the second trigger means,

(5) measuring with timer means the time interval between when the first trigger means is activated and the second trigger means is activated,

(6) determining with volume determining means a volume of the vessel that was filled in the time interval between when the first trigger means is activated and the second trigger means is activated,

(7) determining the flow rate of the liquid stream based on the time measured at step (5) and the volume determined at step (6),

(8) setting the liquid stream control means for draining the vessel, and

(9) repeating steps (2) to (8) for substantially continuously determining the flow rate of the liquid stream.

50. The method as recited in claim 48, wherein the step of substantially continuously determining the flow rate of the liquid stream, further comprises the substeps of,

(1) controlling with liquid stream control means for filling and draining a vessel with liquid from the liquid stream,

(2) setting the liquid stream control means for filling the vessel with liquid from the liquid stream at a natural flow rate of the liquid stream,

(3) activating a first trigger means when a level of the liquid filling the vessel is at a predetermined location with respect to the first trigger means,

(4) activating a selected one of N trigger means at a time after the activation of the first trigger means when the level of the liquid filling the vessel is at a predetermined location with respect to the selected one of N trigger means, with N≧

1,

(5) measuring with timer means the time interval between when the first trigger means is activated and when the selected one of N second trigger means is activated,

(6) determining with volume determining means a volume of the vessel that was filled in the time interval between when the first trigger means is activated and when the selected one of N trigger means is activated,

(7) determining the flow rate of the liquid stream based on the time measured at step (e) and the volume determined at step (f),

(8) setting the liquid stream control means for draining the vessel, and

(9) repeating steps (2) to (8) for substantially continuously determining the flow rate of the liquid stream.

51. The method as recited in claim 50, wherein the method further includes the substep of tracking the determinations of flow rate as a function of time for a predetermined time period.

52. The method as recited in claim 48, wherein the step of substantially continuously determining the concentration of the constituent in the liquid stream, further comprises the substeps of,

(1) irradiating the liquid stream containing the constituent with an energy source and exciting the constituent to produce a spectral response in a known frequency band to indicate the amount of the constituent in the volume;

(2) detecting the spectral response produced by the constituent when exposed to the energy source at step (1); and

(3) the computer processing the spectral response detected by the spectrometer and generating a measurement of a concentration of constituent in the liquid stream.

53. The method as recited in claim 48, wherein the method further includes the step of activating an alarm if there is a change in the mass excretion rate of the constituent in the liquid stream that is indicative of the onset of the condition indicative of such change.

54. The method as recited in claim 48, wherein the liquid stream includes a urine stream.

55. The method as recited in claim 54, wherein the constituent includes creatinine.

56. The method as recited in claim 54, wherein the constituent includes urea.

57. The method as recited in claim 48, wherein the liquid stream includes being input from catheter.

58. The method as recited in claim 57, wherein the liquid stream includes being input from a Foley catheter.

59. The method as recited in claim 48, wherein the method further includes setting an alarm to be activated when the change is indicative of an onset of kidney dysfunction.

60. The method as recited in claim 48, wherein the method further includes setting an alarm to be activated when the change is indicative of an onset of oliguria.

61. The method as recited in claim 48, wherein the method further includes setting an alarm to be activated when the change is indicative of an onset of dehydration in a patient.

62. The method as recited in claim 48, wherein the method further includes setting an alarm to be activated when the change is indicative of an onset of Acute Renal Failure.

63. The method as recited in claim 48, wherein the method further includes monitoring for a general health of an organ system.

64. The method as recited in claim 48, wherein the method further includes monitoring for a recovery from a disease condition.

65. The method as recited in claim 64, wherein the method further includes monitoring for recovery from Acute Renal Failure.

66. The method as recited in claim 48, wherein the method further includes monitoring for a recovery from dialysis.

70. The method as recited in claim 48, wherein the method further includes activating an alarm if there is a change in the flow rate of the liquid stream indicative of the onset of the condition indicative of such change.