Method and apparatus for noninvasively determining hematocrit

• US 5,642,734 A
• Filed: 02/16/1996
• Issued: 07/01/1997
• Est. Priority Date: 10/04/1990
• Status: Expired due to Term

• Current Assignee: Microcor, Inc.
• Original Assignee: Microcor, Inc.
• Inventors: Ruben, Paul, Kaminsky, Allan L.
• Primary Examiner(s): Sykes, Angela D.
• Assistant Examiner(s): WINAKUR, ERIC FRANK
• Application Number:
  US08/602,700
• Time in Patent Office: 501 Days
• Field of Search: 128/693, 128/694, 128/734, 364/413.02, 364/413.07
• US Class Current: 600/506
• CPC Class Codes: A61B 5/14535 for measuring haematocrit
• CPC Class Codes: A61B 5/4869 Determining body composition
• CPC Class Codes: A61B 5/7264 Classification of physiological signals or data, e.g. using neural networks, statistical classifiers, expert systems or fuzzy systems neural networks per se G06N3/00; expert systems per se G06N5/00
• CPC Class Codes: G01N 33/49 Blood chemical methods for determining blood cell populations G01N33/5094; chemical analysis of blood groups or blood types G01N33/80

Abstract

A method and apparatus for noninvasively determining hematocrit utilizing the frequency-dependent electrical impedance characteristics of whole blood by electrically stimulating a patient body portion containing a vascular compartment with a current source over a range of frequencies. A hematocrit measurement system includes a signal generator and demodulator (SGD) that sends an applied signal to an electrode pod that applies a current to a limb of a patient. The electrode pod receives resulting measured voltage signals and provides them to the SGD. The SGD provides to a personal computer (PC) signals indicative of the current passing through the limb of a patient and the resulting voltage. The voltage and current may be measured for various frequencies over, for example, a range from about 10 kHz to about 10 MHz. The electrical impedance from the blood alone is isolated from the total limb impedance from the blood, tissue, bone, etc. by determining the difference between measurements at different blood volumes. The hematocrit is determined by the PC based on inphase and quadrature data provided by the SGD. A neural network may be useful in determining the hematocrit from the blood impedance patterns.

Claims

1. A system for noninvasive determination of hematocrit of blood in a body portion of a patient, the system comprising:

signal generation circuitry to produce alternating and quadrature signals at various frequencies;

processing, sensing, and application circuitry to provide current signals through the body portion in response to the alternating signals, and to sense the current signals being applied and produce current indicating signals in response thereto, and to sense voltage signals over a section of the body portion and produce voltage indicating signals in response thereto;

processing and demodulation circuitry to receive and mix the current indicating signals and the alternating and quadrature signals to produce inphase and quadrature current representing signals, and to receive the voltage indicating signals and mix the voltage indicating signals and the alternating and quadrature signals to produce inphase and quadrature voltage representing signals; and

evaluation circuitry to receive and process the inphase and quadrature current representing signals and inphase and quadrature voltage representing signals to determine the hematocrit.

2. The system of claim 1 in which the evaluation circuitry includes a neural network in which parameters of the processed inphase and quadrature current representing signals and inphase and quadrature voltage representing signals are included in a comparison with pre-gathered data to determine the hematocrit.

3. The system of claim 2 in which parameters regarding the patient are also included in the comparison.

4. The system of claim 2 in which the pre-gathered data includes parameters regarding processed inphase and quadrature current representing signals and inphase and quadrature voltage representing signals of various persons other than the patient.

5. The system of claim 1 in which the evaluation circuitry has access to and considers a group of hematocrit data representative of numerous persons.

6. The system of claim 1 further comprising a blood flow restriction device for restricting flow of blood in the body portion, thereby allowing blood volume in the body portion to change between at least a first and a second volume;

and in which the processing, sensing, and application circuitry produces current indicating signals and voltage indicating signals for at least the first and second volumes.

7. The system of claim 6 in which the blood flow restriction device includes a pressure cuff.

8. The system of claim 1 in which the body portion includes a portion of a finger of the patient.

9. The system of claim 1 in which the various frequencies range from 10 kHz to 10 MHz.

10. The system of claim 1 in which the processing and demodulation circuitry is included in a microprocessor system.

11. The system of claim 1 in which the signal generation circuitry is included in a microprocessor system.

12. The system of claim 1 in which the processing and demodulation circuitry and the signal generation circuitry are included in a microprocessor system.

13. The system of claim 1 in which the processing, sensing, and application circuitry includes a switch through which the voltage indicating signals and current indicating signals alternatively pass.

14. The system of claim 1 in which the processing and demodulation circuitry includes low pass filters with outputs and the inphase and quadrature current representing signals, and inphase and quadrature voltage representing signals are provided at the outputs of the low pass filters.

15. A system for noninvasive determination of hematocrit of blood of a patient, the system comprising:

signal generation circuitry to produce alternating signals at various frequencies and out-of-phase signals with respect to the alternating signals;

processing, sensing, and application circuitry to provide current signals through the blood in response to the alternating signals, and that senses the current signals being applied and produces current indicating signals in response thereto, and that senses voltage signals over a section of the blood and produces voltage indicating signals in response thereto;

processing and demodulation circuitry to receive and mix the current indicating signals and the alternating and out-of-phase signals to produce inphase and out-of-phase current representing signals and to receive the voltage indicating signals and mix the voltage indicating signals and the inphase and out-of-phase voltage representing signals to produce inphase and out-of-phase voltage representing signals; and

evaluation circuitry to receive and process the inphase and out-of-phase current representing signals and inphase and out-of-phase voltage representing signals to determine the hematocrit.

16. The system of claim 15 in which the evaluation circuitry includes a neural network in which parameters of the processed inphase and out-of-phase current representing signals and inphase and out-of-phase voltage representing signals are included in a comparison with pre-gathered data to determine the hematocrit.

17. The system of claim 16 in which parameters regarding the patient are also included in the comparison.

18. The system of claim 16 in which the pre-gathered data includes parameters regarding processed inphase and out-of-phase current representing signals and inphase and out-of-phase voltage representing signals of other persons.

19. The system of claim 15 in which the section of blood is in a limb of the patient, and further comprising a blood flow restriction device for restricting flow of blood in a limb, thereby allowing blood volume in a limb to change between at least a first and a second volume;

and in which the processing, sensing, and application circuitry produces current indicating signals and voltage indicating signals for at least the first and second volumes.

20. The system of claim 15 in which the processing, sensing, and application circuitry includes two outer electrodes and two inner electrodes applied to the housing portion of the patient, and the current signals are applied through the two outer electrodes and the voltage signals are sensed through the two inner electrodes.

21. The system of claim 15 in which the processing, sensing, and application circuitry includes two outer electrodes and two inner electrodes applied to the body portion of the patient, and the current signals are applied through the two inner electrodes and the voltage signals are sensed through the two outer electrodes.

22. A system for noninvasive determination of hematocrit of blood in a body portion of a patient, the system comprising:

signal generation means for producing alternating and quadrature signals at various frequencies;

processing, sensing, and application means for providing first signals through the body portion in response to the alternating signals, and sensing the first signals being applied and producing first indicating signals in response thereto, and sensing second signals over a section of the body portion and producing second indicating signals in response thereto;

processing and demodulation means for receiving and mixing the first indicating signals and the alternating and quadrature signals to produce inphase and quadrature first representing signals, and receiving the second indicating signals and mixing the second indicating signals and the alternating and quadrature signals to produce inphase and quadrature second representing signals; and

evaluation means for receiving and processing the inphase and quadrature first representing signals and inphase and quadrature second representing signals to determine the hematocrit.

23. The system of claim 22 in which the evaluation means includes a neural network in which parameters of the processed inphase and quadrature first representing signals and inphase and quadrature second representing signals are included in a comparison with pre-gathered data to determine the hematocrit.

24. The system of claim 23 in which parameters regarding the patient are also included in the comparison.

25. The system of claim 23 in which the pre-gathered data includes parameters regarding processed inphase and quadrature first representing signals and inphase and quadrature second representing signals of other persons.

26. The system of claim 22, wherein the first signals are current signals and the second signals are voltage signals.

27. A method for noninvasive determination of hematocrit of blood in a body portion of a patient, the method comprising:

injecting alternating current signals having various frequencies into the body portion at different blood volumes, the injected alternating current signals being responsive to generated alternating signals having the various frequencies;

providing current indicating signals representative of the current signals injected into the body portion;

measuring voltage signals across a section of the body portion through which the current signals pass;

providing voltage indicating signals representative of the measured voltage signals;

mixing the current indicating signals with the generated alternating signals and with quadrature signals to produce inphase and quadrature current representative signals;

mixing the voltage indicating signals with the generated alternating signals and with the quadrature signals to produce inphase and quadrature voltage representative signals; and

determining the hematocrit by considering parameters of the inphase and quadrature current representative signals and the inphase and quadrature voltage representative signals.

28. The method of claim 27 in which the step of determining the hematocrit includes employing a neural network in which parameters of the processed inphase and quadrature current representing signals and inphase and quadrature voltage representing signals are included in a comparison with pre-gathered data to determine the hematocrit.

29. A system for developing a group of data with which a hematocrit of blood of a particular patient may be determined, the system comprising:

signal generation circuitry that produces alternating and quadrature signals at various frequencies;

processing, sensing, application circuitry that provides current signals through a body portion of numerous patients in response to the alternating signals, and that senses the current signals being applied and produces current indicating signals in response thereto, and that senses voltage signals over a section of the body portion and produces voltage indicating signals in response thereto; and

processing and demodulation circuitry that receives and mixes the current indicating signals and the alternating and quadrature signals to produce inphase and quadrature current representing signals, and receives and mixes the voltage indicating signals and the alternating and quadrature signals to produce inphase and quadrature voltage representing signals; and

evaluation circuitry that receives and processes the inphase and quadrature current representing signals and inphase and quadrature voltage representing signals and compares parameters of the inphase and quadrature current representing signals and inphase and quadrature voltage representing signals with various pre-gathered data to produce the group of data.

30. An apparatus for noninvasive determination of the relative volume percent of erythrocytes, also termed the hematocrit, of blood having an impedance, comprising:

means for producing a constant current at a first low and at least one second high carrier wave frequencies, said first low frequency being below a frequency zone within which said erythrocytes significantly affect the magnitude of the impedance of said blood, and said at least one second high frequency being within said frequency zone;

means for stimulating a patient body portion including at least one pulsatile vascular compartment containing said blood with said first low and said at least one second high carrier wave frequencies;

means for sensing voltage signals at each of said first low and said at least one second high carrier wave frequencies across said stimulated patient body portion;

means for amplifying said sensed voltage signals;

means for demodulating said amplified, sensed voltage signals to produce at least two complex waveforms respectively proportional to the magnitude of impedance of said blood at said first low and said at least one second high carrier wave frequencies; and

means for processing said at least two complex waveforms to determine said hematocrit of said blood.

31. The apparatus of claim 30, wherein said means for producing a constant current at said first low and said at least one second high carrier wave frequencies comprises a signal generator in combination with a constant current amplifier, and said means for processing determines said first low and said at least one second high carrier wave frequencies.

32. The apparatus of claim 31, wherein said signal generator includes a first and a second adder paired respectively with a first and a second sine/cosine look-up table to produce each of said first low and said at least one second high carrier wave frequencies.

33. The apparatus of claim 32, wherein said first and second look-up tables each produce a sine output, and said signal generator further includes a third adder for summing said outputs and an analog-to-digital converter for converting said summed sine outputs to the digital domain for receipt by said constant current amplifier.

34. The apparatus of claim 31, wherein said signal generator generates a voltage waveform for conversion by said constant current amplifier to a constant current source.

35. The apparatus of claim 30, wherein said means for amplifying comprises a voltage detector.

36. The apparatus of claim 35, wherein said voltage detector comprises an instrumentation amplifier with common mode rejection.

37. The apparatus of claim 30, wherein said means for demodulating comprises a signal generator and a signal demodulator.

38. The apparatus of claim 37, wherein said signal generator includes a first and a second adder paired, respectively, with a first and a second sine/cosine look-up table, to produce each of said first low and said at least one second high carrier wave frequencies.

39. The apparatus of claim 38, wherein said signal demodulator includes a paired low-pass filter and an analog-to-digital converter for receiving said amplified voltage signals.

40. The apparatus of claim 39, wherein said signal demodulator further includes a first, second, third and fourth mixer paired, respectively, with a first, second, third and fourth digital low-pass filter, each of said mixer/filter pairs receiving the output of said paired low-pass filter and analog-to-digital converter and one of a first sine output or a first cosine output from said first look-up table or a second sine output or a second cosine output from said second look-up table, said paired mixers and digital low-pass filters outputting said at least two complex waveforms.

41. The apparatus of claim 30, wherein said first low carrier wave frequency lies at about 100 kHz, and said at least one second high carrier wave frequency lies within the range from about 10 MHz to about 20 MHz.

42. The apparatus of claim 30, further comprising means for selectively occluding said at least one pulsatile vascular compartment.

43. The apparatus of claim 42, wherein said selective occlusion comprises partial occlusion.

44. The apparatus of claim 43, wherein said selective occlusion comprises substantially total occlusion.

45. The apparatus of claim 42, wherein said means for selectively occluding comprises an inflatable cuff surrounding said patient body portion.

46. The apparatus of claim 45, wherein said selective occlusion is performed by pressurizing said cuff in the region of the mean pressure of said at least one pulsatile vascular compartment.

47. The apparatus of claim 42, wherein said means for selectively occluding is located on said patient body portion proximate said means for stimulating and said means for sensing.

48. The apparatus of claim 42, wherein said means for selectively occluding is controlled by said means for processing.

49. The apparatus of claim 30, wherein said patient body portion further includes at least one non-pulsatile vascular compartment, and said apparatus further includes means for selectively occluding said at least one non-pulsatile vascular compartment while said at least one pulsatile vascular compartment remains unoccluded.

50. The apparatus of claim 49, wherein said means for selectively occluding comprises an inflatable cuff surrounding said patient body portion.

51. The apparatus of claim 49, wherein said means for selectively occluding is controlled by said means for processing.

52. The apparatus of claim 30, further comprising means for compensating for non-homogeneous flow of said blood through at least one said pulsatile vascular compartment in determining said hematocrit of said blood.

53. The apparatus of claim 30, further comprising means for determining blood pressure of said blood in said at least one pulsatile vascular compartment.

54. The apparatus of claim 53, wherein said means for determining said blood pressure includes means for selectively occluding said at least one pulsatile vascular compartment.

55. The apparatus of claim 54, wherein said means for selectively occluding at least one said pulsatile vascular compartment is controlled by said means for processing to completely occlude said at least one pulsatile vascular compartment, and to subsequently reduce said complete occlusion by a degree sufficient to induce the appearance of a plethysmographic waveform signal at said means for sensing, to further reduce said occlusion by a degree sufficient to maximize the intensity of said plethysmographic waveform signal, and to still further reduce said occlusion until said plethysmographic waveform undergoes no further change.

56. The apparatus of claim 55, wherein said appearance of said plethysmographic waveform is indicative of systolic pressure of said at least one pulsatile vascular compartment, said maximum signal intensity of said plethysmographic signal is indicative of mean pressure of said at least one pulsatile vascular compartment, and said point at which said plethysmographic waveform ceases to change is indicative of diastolic pressure of said at least one pulsatile vascular compartment.

57. The apparatus of claim 56, wherein said means for selectively occluding comprises a cuff disposed about said patient body portion and inflatable to a pressure sufficient to occlude said at least one pulsatile vascular compartment, and said indication of said systolic, mean and diastolic pressure of said at least one pulsatile vascular compartment is correlated to the actual systolic, mean and diastolic pressures of said at least one pulsatile vascular compartment by pressure transducer means associated with said cuff, the output of which is converted by said processing means to said actual pressures.

58. The apparatus of claim 30, wherein said means for producing a constant current comprises means for producing said current at a plurality of said second high carrier wave frequencies.

59. The apparatus of claim 30, wherein said means for processing said at least two complex waveforms employs the magnitudes thereof to determine said hematocrit of said blood.

60. The apparatus of claim 30, wherein said means for processing said at least two complex waveforms employs the magnitudes and phases thereof to determine said hematocrit of said blood.

61. The apparatus of claim 30, wherein said first low carrier wave frequency lies at about 100 kHz, and said at least one second high carrier wave frequency lies between 100 kHz and about 10 MHz.

62. A method for noninvasive determination of the relative volume percent of erythrocytes, also termed the hematocrit, of blood having an impedance, comprising:

producing a constant current at a first low and at least one second high carrier wave frequencies, said first low frequency being below a frequency zone within which said erythrocytes significantly affect the magnitude of the impedance of said blood, and said at least one second high frequency being within said frequency zone;

stimulating a patient body portion including at least one pulsatile vascular compartment containing said blood with said first low and said at least one second high carrier wave frequencies;

sensing voltage signals at each of said first low and said at least one second high carrier wave frequencies across said stimulated patient body portion;

amplifying said sensed voltage signals;

demodulating said amplified, sensed voltage signals to produce at least two complex waveforms respectively proportional to the magnitude of impedance of said blood at said first low and said at least one second high carrier wave frequencies; and

processing said at least two complex waveforms to determine said hematocrit of said blood.

63. The method of claim 62, further comprising producing said constant current at a plurality of said second high carrier wave frequencies.

64. The method of claim 62, wherein processing said at least two complex waveforms employs the magnitudes thereof to determine said hematocrit of said blood.

65. The method of claim 62, wherein processing said at least two complex waveforms employs the magnitudes and phases thereof to determine said hematocrit of said blood.

66. The method of claim 62, wherein said first low carrier wave frequency lies at about 100 kHz, and said at least one second high carrier wave frequency lies within the range from about 10 MHz to about 20 MHz.

67. The method of claim 62, wherein said first low carrier wave frequency lies at about 100 kHz, and said at least one second high carrier wave frequency lies between 100 kHz and about 10 MHz.

68. The method of claim 62, further comprising selectively occluding said at least one pulsatile vascular compartment.

69. The method of claim 68, wherein said selective occlusion comprises partial occlusion.

70. The method of claim 68, wherein said selective occlusion comprises substantially total occlusion.

71. The method of claim 68, wherein said selective occlusion is effected by applying pressure about said at least one pulsatile vascular compartment in the region of the mean pressure of said at least one pulsatile vascular compartment.

72. The method of claim 68, wherein said selective occlusion is effected on said patient body portion proximate locations thereon wherein said stimulating and said sensing are performed.

73. The method of claim 62, wherein said patient body portion further includes at least one non-pulsatile vascular compartment, and said method further includes selectively occluding said at least one non-pulsatile vascular compartment while said at least one pulsatile vascular compartment remains unoccluded.

74. The method of claim 62, further comprising compensating for non-homogeneous flow of said blood through said at least one pulsatile vascular compartment in determining said hematocrit of said blood.

75. The method of claim 62, further comprising determining blood pressure of said blood in said at least one pulsatile vascular compartment.

76. The method of claim 75, wherein said determining said blood pressure includes selectively occluding said at least one pulsatile vascular compartment.

77. The method of claim 76, wherein said at least one selective occlusion of said pulsatile vascular compartment for determination of blood pressure includes completely occluding said at least one pulsatile vascular compartment, subsequently reducing said complete occlusion by a degree sufficient to induce the appearance of a plethysmographic waveform signal, to further reduce said occlusion by a degree sufficient to maximize the intensity of said plethysmographic waveform signal, and to still further reduce said occlusion until said plethysmographic waveform undergoes no further change.

78. The method of claim 77, wherein said appearance of said plethysmographic waveform is indicative of systolic pressure of said at least one pulsatile vascular compartment, said maximum signal intensity of said plethysmographic signal is indicative of mean pressure of said at least one pulsatile vascular compartment, and said point at which said plethysmographic waveform ceases to change is indicative of diastolic pressure of said at least one pulsatile vascular compartment.

79. The method of claim 78, further including selectively occluding using a cuff disposed about said patient body portion and inflatable to a pressure sufficient to occlude said pulsatile vascular compartment, and said indication of said systolic, mean and diastolic pressure of said pulsatile vascular compartment is correlated to the actual systolic, mean and diastolic pressures of said vascular compartment by pressure transducer means associated with said cuff, the output of which is processed to said actual pressures.

80. An apparatus for determining blood pressure in a pulsatile vascular compartment of a patient body portion containing blood, comprising:

means for producing a constant current at a carrier wave frequency;

means for stimulating said patient body portion including said pulsatile vascular compartment containing said blood with said constant current;

means for sensing a voltage signal at said carrier wave frequency across said stimulated patient body portion;

means for amplifying said sensed voltage signal;

means for demodulating said amplified, sensed voltage signal to produce a plethysmographic waveform signal;

means for sensing the existence, magnitude and shape of said plethysmographic waveform signal;

means for selectively occluding said pulsatile vascular compartment to completely occlude said pulsatile vascular compartment and suppress said plethysmographic waveform signal, to subsequently reduce said complete occlusion by a degree sufficient to induce the appearance of said plethysmographic waveform signal, to further reduce said occlusion by a degree sufficient to maximize the intensity of said plethysmographic waveform signal, and to still further reduce said occlusion until said plethysmographic waveform undergoes no further change.

81. The apparatus of claim 80, wherein said appearance of said plethysmographic waveform is indicative of systolic pressure of said pulsatile vascular compartment, said maximum signal intensity of said plethysmographic signal is indicative of mean pressure of said pulsatile vascular compartment, and said point at which said plethysmographic waveform ceases to change is indicative of diastolic pressure of said pulsatile vascular compartment.

82. The apparatus of claim 81, wherein said means for selectively occluding comprises a cuff disposed about said patient body portion and inflatable to a pressure sufficient to occlude said pulsatile vascular compartment, and said indication of said systolic, mean and diastolic pressure of said pulsatile vascular compartment is correlated to the actual systolic, mean and diastolic pressures of said vascular compartment by pressure transducer means associated with said cuff.

83. A method of compensating for non-homogeneous blood flow in a pulsatile vascular compartment of a patient body portion to enhance the accuracy of detection of a blood-related parameter at said patient body portion, comprising:

applying electrical current signals having selected frequencies across at least a portion of said body portion; and

occluding said pulsatile vascular compartment during at least a portion of the cardiac cycle of said patient while detecting said blood-related parameter while said electrical current signals are applied.

84. The method of claim 83, wherein said occlusion further comprises application of pressure to said pulsatile vascular compartment in the region of the mean pressure thereof.

85. A method of compensating for non-homogeneous blood flow in a pulsatile vascular compartment of a patient body portion to enhance the accuracy of detection of a blood-related parameter at said patient body portion, said patient body portion also including a non-pulsatile vascular compartment, said method comprising:

applying electrical current signals having selected frequencies across at least a portion of said body portion; and

applying pressure to said patient body portion sufficient to occlude said non-pulsatile vascular compartment while permitting blood flow through said pulsatile vascular compartment and detecting said blood-related parameter while said electrical current signals are applied.