Apparatus and method for measuring an induced perturbation to determine a physiological parameter

• US 5,833,618 A
• Filed: 11/22/1995
• Issued: 11/10/1998
• Est. Priority Date: 04/15/1994
• Status: Expired due to Term

• Current Assignee: Masimo Corporation
• Original Assignee: Vital Insite, Inc.
• Inventors: Caro, Richard G., Sher, Mark H.
• Primary Examiner(s): Nasser, Robert L.
• Application Number:
  US08/561,923
• Time in Patent Office: 1,084 Days
• Field of Search: 128/630.2, 128/623, 128/664.7, 128/672-656, 128/713, 128/716, 128/719, 128/721, 128/2, 128/736, 128/740
• US Class Current: 600/485
• CPC Class Codes: A61B 5/02108 from analysis of pulse wave characteristics
• CPC Class Codes: A61B 5/02133 by using induced vibration of the blood vessel
• CPC Class Codes: A61B 5/022 by applying pressure to close blood vessels, e.g. against the skin; Ophthalmodynamometers

Abstract

A monitor for determining a patient'"'"'s physiological parameter includes a calibration device configured to provide a calibration signal representative of the patient'"'"'s physiological parameter. An exciter is positioned over a blood vessel of the patient for inducing a transmitted exciter waveform into the patient. A noninvasive sensor is positioned over the blood vessel, where the noninvasive sensor is configured to sense a hemoparameter and to generate a noninvasive sensor signal representative of the hemoparameter containing a component of a physiological parameter waveform and a component of a received exciter waveform. In this context, a hemoparameter is defined as any physiological parameter related to vessel blood such as pressure, flow, volume, velocity, blood vessel wall motion, blood vessel wall position and other related parameters. A processor is configured to determine a relationship between a property of the received exciter waveform and a property of the physiological parameter. The processor is connected to receive the calibration signal and the noninvasive sensor signal, and the processor is configured to process the calibration signal and the noninvasive sensor signal to determine the physiological parameter. In the preferred embodiment, the physiological parameter measured is blood pressure, however, the present invention can also be used to analyze and track other physiological parameters such as vascular wall compliance, strength of ventricular contractions, vascular resistance, fluid volume, cardiac output, myocardial contractility and other related parameters.

Claims

1. A monitor for determining a physiological parameter of a patient comprising:

a calibration device configured to provide a calibration signal representative of one of the patient'"'"'s physiological parameters;

an exciter adapted to be positioned over a blood vessel of the patient and configured to induce a transmitted exciter waveform into the patient;

a noninvasive sensor adapted to be positioned over said blood vessel and configured to sense a hemoparameter and to generate a noninvasive sensor signal representative of said hemoparameter containing a component of a received exciter waveform;

a processor configured to determine a relationship between a property of said received exciter waveform and a property of said physiological parameter;

wherein said processor includes a filter configured to separate a signal exciter waveform component of said noninvasive sensor signal from at least one other component of said noninvasive sensor signal; and

wherein said processor is connected to receive said calibration signal and said noninvasive sensor signal and is configured to determine said physiological parameter based at least in part on said calibration signal, said signal exciter waveform component, and said relationship.

4. The monitor of one of claims 1, 2 or 3, wherein:

said processor is further configured to determine a relationship between a component of said received exciter waveform and an amplitude and value of said physiological parameter.

5. The monitor of one of claims 1, 2 or 3, wherein:

said processor is further configured to determine a relationship between an amplitude and phase, of a component of said received exciter waveform and an amplitude and value of said physiological parameter.

7. The monitor of one of claims 1, 2, 3 or 6, wherein:

said processor is responsive to said noninvasive sensor signal, and further configured to determine the validity of said calibration signal and to initiate a calibration when said calibration signal is not valid.

8. The monitor of one of claims 1, 2, 3 or 6, wherein:

said processor is further configured to scale said physiological parameter waveform based on the relationship between a property of said received exciter waveform and a property of said physiological parameter and to generate a scaled physiological parameter waveform signal.

2. A monitor for determining a physiological parameter of a patient comprising:

a calibration device configured to provide a calibration signal representative of one of the patient'"'"'s physiological parameters;

an exciter adapted to be positioned over a blood vessel of the patient and configured to induce a transmitted exciter waveform into the patient;

a noninvasive sensor adapted to be positioned over said blood vessel and configured to sense a hemoparameter and to generate a noninvasive sensor signal representative of said hemoparameter containing a component of a received exciter waveform;

a processor configured to determine a relationship between a property of said received exciter waveform and a property of said physiological parameter;

wherein said processor includes a filter configured to separate a component of said noninvasive sensor signal having a phase that varies with blood pressure from at least one other component of said noninvasive sensor signal having a phase that does not so vary; and

wherein said processor is connected to receive said calibration signal and said noninvasive sensor signal and is configured to determine said physiological parameter based at least in part on said calibration signal, said component having a phase that varies with blood pressure, and said relationship.

3. The monitor of claim 2, wherein:

said processor includes a filter configured to determine an are representing time varying positions of said received exciter waveform, to determine a center point of said are and to determine a noise vector from an origin to said center point; and

said processor is configured to determine an arc vector from said center point to said time varying positions, where said arc vector has an arc vector angle that moves from a first angle to a second angle over time; and

wherein said processor is configured to process said arc vector angle to determine said physiological parameter.

6. A monitor for determining a physiological parameter of a patient, comprising:

a calibration device configured to provide a calibration signal representative of one of the patient'"'"'s physiological parameters;

an exciter adapted to be positioned over a blood vessel of the patient and configured to induce a transmitted exciter waveform into the patient;

a noninvasive sensor adapted to be positioned over said blood vessel and configured to sense a hemoparameter and to generate a noninvasive sensor signal representative of said hemoparameter containing a component of a received exciter waveform;

a processor configured to determine a relationship between a property of said received exciter waveform and a property of said physiological parameter; and

wherein said processor is connected to receive said calibration signal and said noninvasive sensor signal and is configured to determine said physiological parameter based at least in part on said calibration signal, said noninvasive sensor signal and said relationship;

wherein said exciter is further configured to induce a second transmitted exciter waveform into the patient; and

wherein said processor includes a filter configured to separate from said noninvasive sensor signal a component of one of the group consisting of said physiological parameter waveform, said received exciter waveform, a second received exciter waveform, a signal exciter waveform, second signal exciter waveform and a noise waveform.

9. A processor for determining a physiological parameter of a patient with an apparatus having a calibration device configured to provide a calibration signal representative of one of the patient'"'"'s physiological parameters, an exciter adapted to be positioned over a blood vessel of the patient and configured to induce a transmitted exciter waveform into the patient, and a noninvasive sensor adapted to be positioned over said blood vessel and configured to sense a hemoparameter and to generate a noninvasive sensor signal representative of said hemoparameter, said processor comprising:

a first input configured to receive said calibration signal;

a second input configured to receive said noninvasive sensor signal;

a filter configured to from said noninvasive sensor signal a component representing a received exciter waveform;

a relationship routine configured to determine a relationship between a property of said received exciter waveform and a property of said physiological parameter;

wherein said filter is configured to separate a component of said noninvasive sensor signal having a phase that varies with blood pressure from at least one other component of said noninvasive sensor signal having a phase that does not so vary; and

a determination routine to determine said physiological parameter based at least in part on said calibration signal, said component having a phase that varies with blood pressure, and said relationship.

10. The processor of claim 9, wherein:

said filter is configured to determine an arc representing time varying positions of said received exciter waveform, to determine a center point of said arc and to determine a noise vector from an origin to said center point; and

said filter is configured to determine an arc vector from said center point to said time varying positions, where said arc vector has an arc vector angle that moves from a first angle to a second angle over time; and

wherein said determination routine is configured to process said are vector angle to determine said physiological parameter.

11. The processor of one of claims 9 or 10, wherein:

said determination routine is further configured to compare a phase relationship between said transmitted exciter waveform and a component of said noninvasive sensor signal to determine said physiological parameter.

12. The processor of one of claims 9 or 10 wherein:

said filter is further configured to separate from said noninvasive sensor signal a component representing a second received exciter waveform.

13. The processor of one of claims 9 or 10, wherein:

said determination routine is further configured to compare a phase relationship between said transmitted exciter waveform and a component of said noninvasive sensor signal, and to compare a phase relationship between a second transmitted exciter waveform and a component of said noninvasive sensor signal to determine said physiological parameter.

14. A method for determining a physiological parameter of a patient comprising:

providing a calibration signal representative of one of the patient'"'"'s physiological parameters and storing the calibration signal;

inducing a transmitted exciter waveform into the patient;

noninvasively sensing a hemoparameter and generating a noninvasive sensor signal representative of said hemoparameter containing a component of a received exciter waveform; and

processing said noninvasive sensor signal including the steps of;

(a) determining a relationship between a property of said received exciter waveform and a property of said physiological parameter;

(b) separating a signal exciter waveform component of said noninvasive sensor signal from at least one other component of said noninvasive sensor signal; and

(c) determining said physiological parameter based at least in part on said calibration signal, said signal exciter waveform component, and said relationship.

17. The method of one of claims 14, 15 or 16, wherein:

said processing step includes determining a relationship between a component of said received exciter waveform and an amplitude and value of said physiological parameter.

18. The method of one of claims 14, 15 or 16, wherein:

said processing step includes determining a relationship between an amplitude and phase of a component of said received exciter waveform and an amplitude and value of said physiological parameter.

20. The method of one of claims 14, 15, 16 or 19, wherein:

said processing step includes determining the validity of said calibration signal and initiating said step of providing a calibration signal when said calibration signal is not valid.

21. The method of one of claims 14, 15, 16 or 19, wherein:

said processing step includes scaling said physiological parameter waveform based on the relationship between a property of said received exciter waveform and a property of said physiological parameter and generating a scaled physiological parameter waveform signal.

15. A method for determining a physiological parameter of a patient comprising:

providing a calibration signal representative of one of the patient'"'"'s physiological parameters and storing the calibration signal;

inducing a transmitted exciter waveform into the patient;

noninvasively sensing a hemoparameter and generating a noninvasive sensor signal representative of said hemoparameter containing a component of a received exciter waveform; and

processing said noninvasive sensor signal including the steps of;

(a) determining a relationship between a property of said received exciter waveform and a property of said physiological parameter;

(b) separating a signal exciter waveform a component of said noninvasive sensor signal having a phase that varies with blood pressure from at least one other component of said noninvasive sensor signal having a phase that does not so vary; and

(c) determining said physiological parameter based at least in part on said calibration signal, said component having a phase that varies with blood pressure, and said relationship.

16. The method of claim 15, wherein:

said processing step includes a filtering step of determining an arc representing time varying positions of said received exciter waveform, determining a center point of said arc and determining a noise vector from an origin to said center point; and

said processing step includes a filtering step of determining an arc vector from said center point to said time varying positions, where said arc vector has an arc vector angle that moves from a first angle to a second angle over time.

19. A of determining a physiological parameter of a patient, comprising the steps of:

providing a calibration signal representative of one of the patient'"'"'s physiological parameters and storing the calibration signal;

inducing a transmitted exciter waveform into the patient;

noninvasively sensing a hemoparameter and generating a noninvasive sensor signal representative of said hemoparameter containing a component of a received exciter waveform;

processing said noninvasive sensor signal including the steps of;

(a) determining a relationship between a property of said received exciter waveform and a property of said physiological parameter; and

(b) determining said physiological parameter based at least in part on said calibration signal, said noninvasive sensor signal and said relationship;

inducing a second transmitted exciter waveform into the patient; and

wherein said processing step includes a filtering step of separating from said noninvasive sensor signal a component of one of the group consisting of said physiological parameter waveform, said received exciter waveform, a second received exciter waveform, a signal exciter waveform, a second signal exciter waveform and a noise waveform.

22. A monitor for determining a patient'"'"'s blood pressure comprising:

an inflatable cuff adapted to be positioned on an extremity of the patient and configured to provide a calibration signal representative of one of the patient'"'"'s physiological parameters;

an exciter adapted to be positioned over a blood vessel of the patient and configured to induce a transmitted exciter waveform into the patient;

a noninvasive sensor adapted to be positioned over said blood vessel at a distance from said exciter and configured to sense a hemoparameter and to generate a noninvasive sensor signal representative of said hemoparameter containing a component of a received exciter waveform;

a processor configured to determine a relationship between a property of said received exciter waveform and a property of said physiological parameter;

wherein said processor is connected to receive said calibration signal and said noninvasive sensor signal;

wherein said processor includes a filter configured to separate a component of said noninvasive sensor signal having a phase that varies with blood pressure from at least one other component of said noninvasive sensor signal having a phase that does not so vary; and

wherein said processor is configured to determine said blood pressure based at least in part on said calibration signal, said component having a phase that varies with blood pressure, and said relationship.

23. The monitor of claim 22, further comprising:

an exciter sensor adapted to be positioned near said exciter and configured to sense said transmitted exciter waveform and to generate an exciter sensor signal representative of said transmitted exciter waveform; and

wherein said processor is further configured to compare the phase relationship of said transmitted exciter sensor signal and said received exciter waveform to determine said blood pressure.

24. A method of obtaining data of blood pressure of a patient, comprising:

noninvasively inducing into an artery of the patient a repetitive pressure wave;

noninvasively monitoring a characteristic of the repetitive wave upon modification by the artery;

determining a relationship between magnitudes of the monitored wave characteristic and blood pressure;

using the monitored wave characteristic and said relationship in a manner to provide the blood pressure of the patient; and

noninvasively monitoring relative values of the blood pressure in the artery of the patient, and wherein using the monitored wave characteristic and said relationship includes scaling the monitored relative values of the blood pressure by the monitored wave characteristic and said relationship in a manner to provide absolute values of said blood pressure.

25. The method of claim 24, wherein monitoring the wave characteristic and monitoring the relative blood pressure values include use of a single transducer having an electrical signal output that is separated into components of the repetitive pressure wave and relative blood pressure by filtering.

29. The method of one of claims 24, 25, 26 or 27, wherein determining the relationship between magnitudes of said wave characteristic and values of blood pressure is accomplished on the patient.

30. The method of one of claims 24, 25 and 27, wherein using the monitored wave characteristic and said relationship includes processing the monitored characteristic of the pressure wave after modification by the artery in a manner to separate a component that varies with a period of the blood pressure from other components that do not so vary, thereby to filter out a desired component of the monitored characteristic.

31. The method of one of claims 24, 25, 26, 27 or 28, which additionally comprises displaying the values of the blood pressure of the patient as a curve.

32. The method of one of claims 24, 25 or 26, wherein the noninvasive monitoring of a characteristic of the repetitive wave includes measuring the characteristic between two spaced apart locations along a length of the artery.

33. The method of one of claims 24, 25 or 26 wherein the noninvasive monitoring of a characteristic of the repetitive wave includes measuring the characteristic between two spaced apart locations along a length of the artery, and the characteristic being measured includes a relative phase of said pressure wave at said two spaced apart locations.

26. A method of obtaining data of blood pressure of a patient, comprising:

noninvasively inducing into an artery of the patient a repetitive wave upon modification by the artery;

determining a relationship between magnitudes of the monitored wave characteristic and blood pressure;

using the monitored wave characteristic and said relationship in a manner to provide the blood pressure of the patient; and

wherein using the monitored wave characteristic and said relationship includes processing the monitored characteristic of the pressure wave after modification by the artery in a manner to separate a component that varies with a period of the blood pressure from other, components that do not so vary, thereby to filter out a desired component of the monitored characteristic.

27. The method of claim 26, wherein the noninvasive monitoring of a characteristic of the repetitive wave includes measuring the characteristic between two spaced apart locations along a length of the artery.

28. The method of claim 27 wherein the characteristic being measured includes a relative phase of said pressure wave between said two spaced apart locations.

34. A method of obtaining data of blood pressure of a patient, comprising:

noninvasively inducing into an artery of the patient a repetitive pressure wave,

noninvasively monitoring a characteristic of the pressure wave between two spaced apart locations along a length of the artery,

processing the monitored characteristic of the pressure wave by separating a component that varies with a period of the blood pressure from other components that do not so vary, thereby to filter out a desired component of the monitored characteristic that is related to blood pressure, and

determining the blood pressure from the filtered component.

35. The method of claim 34 wherein the monitored characteristic includes a relative phase of said pressure wave between said two spaced apart locations.

36. The method of claims 34 or 35, which additionally comprises displaying the determined blood pressure of the patient as a curve.

37. A monitor for determining a physiological parameter of a patient comprising:

an exciter adapted to be positioned over a blood vessel of the patient and configured to induce a transmitted exciter waveform into the patient;

a noninvasive sensor adapted to be positioned over said blood vessel and configured to sense a hemoparameter and to generate a noninvasive sensor signal representative of said hemoparameter containing a received exciter waveform component and a physiological waveform component;

a processor configured to utilize a relationship between a property of said received exciter waveform component and a property of said physiological parameter;

wherein said processor is configured to scale said noninvasive sensor signal including said physiological waveform component by use of said relationship to generate a scaled waveform; and

wherein said processor is connected to receive said sensor signal and is configured to determine said physiological parameter based at least in part on said scaled waveform.

41. The monitor of one of claims 37, 38, 39 or 40 wherein the physiological parameter being monitored includes blood pressure.

38. A monitor for determining a physiological parameter of a patient comprising:

an exciter adapted to be positioned over a blood vessel of the patient and configured to induce a transmitted exciter waveform into the patient;

a noninvasive sensor adapted to be positioned over said blood vessel and configured to sense a hemoparameter and to generate a noninvasive sensor signal representative of said hemoparameter containing a received exciter waveform component and a physiological waveform component;

a processor configured to utilize a relationship between a property of said received exciter waveform component and a property of said physiological parameter;

wherein said processor is connected to receive said sensor signal and is configured to determine said physiological parameter based at least in part on said sensor signal and said relationship; and

means in addition to said sensor for noninvasively monitoring relative values of the physiological parameter of the patient, and wherein said processor is additionally configured for scaling the monitored relative values of the physiological parameter by the sensor signal and said relationship in a manner to provide absolute values of said physiological parameter.

39. A monitor for determining a physiological parameter of a patient comprising:

an exciter adapted to be positioned over a blood vessel of the patient and configured to induce transmitted exciter waveform into the patient;

a noninvasive sensor adapted to be positioned over said blood vessel and configured to sense a hemoparameter and to generate a noninvasive sensor signal representative of said hemoparameter containing a component of a received exciter waveform;

a processor configured to utilize a relationship between a property of said received exciter waveform and a property of said physiological parameter;

wherein said processor is connected to receive said sensor signal and is configured to determine said physiological parameter based at least in part on said sensor signal and said relationship; and

wherein said processor is additionally configured for processing the sensor signal in a manner to separate a component that varies with a period of blood pressure variations in the artery from other components that do not so vary, thereby to filter out a desired component of the sensor signal.

40. The monitor according to claim 39, additionally comprising means coupled with said processor for displaying the values of the physiological parameter of the patient as a curve.

42. A method for determining a physiological parameter of a patient comprising:

noninvasively positioning over a blood vessel of the patient an exciter that induces an exciter waveform into the blood vessel;

noninvasively positioning a sensor over the blood vessel of the patient at a location spaced a distance apart from the exciter along the blood vessel in order to detect a sensor signal of the exciter waveform at said spaced apart location that contains a component representative of a hemoparameter of the patient;

providing a relationship between a property of said sensor signal and a property of said physiological parameter;

separating a component of said noninvasive sensor signal having a phase that varies with blood pressure from at least one other component of said noninvasive sensor signal having a phase that does not so vary; and

determining the physiological parameter from at least said component having a phase that varies with blood pressure, and said relationship.

43. The method of claim 42 wherein said step of determining the physiological parameter includes the step of measuring a phase of the sensor signal relative to that of the waveform induced into the blood vessel by the exciter.

44. The method of one of claims 42, or 43, wherein the physiological parameter of the patient being monitored includes blood pressure.