Continuous non-invasive blood pressure monitoring method and apparatus

• US 6,599,251 B2
• Filed: 07/27/2001
• Issued: 07/29/2003
• Est. Priority Date: 01/26/2000
• Status: Expired due to Term

• Current Assignee: Nellcor Puritan Bennett Ireland
• Original Assignee: VSM Medtech, Ltd.
• Inventors: Chen, Yunquan, Li, Luya, Dill, Ryan Peter, Hershler, Cecil
• Primary Examiner(s): Hindenburg, Max F.
• Assistant Examiner(s): Natnithithadha, Navin
• Application Number:
  US09/917,279
• Publication Number:
  US 20020058876A1
• Time in Patent Office: 732 Days
• Field of Search: 600/481, 600/485, 600/486, 600/490, 600/500, 600/501, 600/502, 600/503
• US Class Current: 600/485
• CPC Class Codes: A61B 5/021 Measuring pressure in heart or blood vessels A61B5/0205 takes precedence
• CPC Class Codes: A61B 5/02125 of pulse wave propagation time
• CPC Class Codes: A61B 5/02255 the pressure being controlled by plethysmographic signals, e.g. derived from optical sensors
• CPC Class Codes: A61B 5/0285 Measuring or recording phase velocity of blood waves
• CPC Class Codes: A61B 5/4884 inducing physiological or psychological stress, e.g. applications for stress testing
• CPC Class Codes: A61B 5/7278 Artificial waveform generation or derivation, e.g. synthesising signals from measured signals A61B5/327 takes precedence

Abstract

A non-invasive apparatus and method for monitoring the blood pressure of a subject detects a pulse signal at both a first and second location on the subject'"'"'s body. The elapsed time between the arrival of corresponding points of the pulse signal at the first and second locations is determined. Blood pressure is related to the elapsed time by relationships such as:

P=a+b ln(T)

where a and b are constants dependent upon the nature of the subject and the signal detecting devices. The system can be calibrated by measuring a single pair of reference blood pressure and corresponding elapsed time.

Claims

1. A method for monitoring blood pressure, the method comprising:

a) detecting a first pulse signal at a first location on a subject and detecting a second pulse signal at a second location on the subject;

b) measuring a reference blood pressure P₀ and a corresponding time difference T₀ between the first and second pulse signals;

c) from the reference blood pressure and corresponding time difference, determining a first plurality of constant parameters in a multi-parameter equation relating blood pressure and the time-difference;

d) monitoring the subject'"'"'s blood pressure by periodically measuring a time difference T between the first and second pulse signals; and

,

e) computing an estimated blood pressure, P, from the time difference, T, using the multi-parameter equation and the first plurality of constant parameters

wherein the multi-parameter equation is the calculation;

2. The method of claim 1 wherein determining the plurality of constant parameters in the multi-parameter equation comprises performing calculations mathematically equivalent to:

$a=c_1+\frac{c_2<br><br>\left(P_0-c_1\right)}{\ln <br><br>\left(T_0\right)+c_2}$$\mathrm{and},<br><br>b=\frac{P_0-c_1}{\ln <br><br>\left(T_0\right)+c_2}$

to obtain values for the constants a and b, where c₁ and c₂ are predetermined constants.

3. The method of claim 1 wherein the plurality of constant parameters comprise a first parameter a and a second parameter b and determining the plurality of constant parameters in the multi-parameter equation comprises performing calculations mathematically equivalent to:

4. A method for monitoring blood pressure, the method comprising:

a) detecting a first pulse signal at a first location on a subject and detecting a second pulse signal at a second location on the subject;

b) measuring a reference blood pressure P₀ and a corresponding time difference T₀ between the first and second pulse signals;

c) from the reference blood pressure and corresponding time difference, determining a first plurality of constant parameters in a multi-parameter equation relating blood pressure and the time-difference;

d) monitoring the subject'"'"'s blood pressure by periodically measuring a time difference T between the first and second pulse signals; and

,

e) computing an estimated blood pressure, P, from the time difference, T, using the multi-parameter equation and the first plurality of constant parameters

wherein the multi-parameter equation comprises a non-linear function which is generally decreasing and concave upward in a manner specified by the constant parameters.

5. The method of claim 4 wherein the function is monotonically decreasing.

6. A method for monitoring blood pressure, the method comprising:

a) detecting a first pulse signal at a first location on a subject and detecting a second pulse signal at a second location on the subject;

b) measuring a reference blood pressure P₀ and a corresponding time difference T₀ between the first and second pulse signals;

c) from the reference blood pressure and corresponding time difference, determining a first plurality of constant parameters in a multi-parameter equation relating blood pressure and the time-difference;

d) monitoring the subject'"'"'s blood pressure by periodically measuring a time difference T between the first and second pulse signals; and

,

e) computing an estimated blood pressure, P, from the time difference, T, using the multi-parameter equation and the first plurality of constant parameters

wherein the multi-parameter equation is the calculation;

ti P=α

T<sup>−

β</sup>

 

or a mathematical equivalent thereof where α and

β

are constants.

7. A method for monitoring blood pressure, the method comprising:

a) detecting a first pulse signal at a first location on a subject and detecting a second pulse signal at a second location on the subject;

b) measuring a reference blood pressure P₀ and a corresponding time difference T₀ between the first and second pulse signals;

c) from the reference blood pressure and corresponding time difference, determining a first plurality of constant parameters in a multi-parameter equation relating blood pressure and the time-difference;

d) monitoring the subject'"'"'s blood pressure by periodically measuring a time difference T between the first and second pulse signals; and

,

e) computing an estimated blood pressure, P, from the time difference, T, using the multi-parameter equation and the first plurality of constant parameters

wherein the multi-parameter equation is the calculation;

8. A method for monitoring blood pressure, the method comprising:

a) detecting a first pulse signal at a first location on a subject and detecting a second pulse signal at a second location on the subject;

b) measuring a reference blood pressure P₀ and a corresponding time difference T₀ between the first and second pulse signals;

c) from the reference blood pressure and corresponding time difference, determining a first plurality of constant parameters in a multi-parameter equation relating blood pressure and the time-difference;

d) monitoring the subject'"'"'s blood pressure by periodically measuring a time difference T between the first and second pulse signals; and

,

e) computing an estimated blood pressure, P, from the time difference, T, using the multi-parameter equation and the first plurality of constant parameters

wherein the blood pressure is a systolic blood pressure.

9. A method for monitoring blood pressure, the method comprising:

a) detecting a first pulse signal at a first location on a subject and detecting a second pulse signal at a second location on the subject;

b) measuring a reference blood pressure P₀ and a corresponding time difference T₀ between the first and second pulse signals;

c) from the reference blood pressure and corresponding time difference, determining a first plurality of constant parameters in a multi-parameter equation relating blood pressure and the time-difference;

d) monitoring the subject'"'"'s blood pressure by periodically measuring a time difference T between the first and second pulse signals; and

,

e) computing an estimated blood pressure, P, from the time difference, T, using the multi-parameter equation and the first plurality of constant parameters

wherein the method comprises measuring a systolic blood pressure of the subject wherein measuring the time difference T comprises measuring a first time difference T_s for portions of the first and second signals which do not include at least some diastolic portions of the signals.

10. A The method of claim 9 comprising additionally measuring a diastolic blood pressure of the subject by measuring a second time difference T_D for portions of the first and second pulse signals which do not include at least some systolic portions of the signals.

11. The method of claim 10 wherein measuring a reference blood pressure comprises measuring a calibration diastolic pressure and the method comprises, from the calibration diastolic blood pressure and corresponding second time difference T_D, determining a second plurality of constant parameters in the multi-parameter equation relating blood pressure and the second time-difference;

and

the method comprises monitoring the subject'"'"'s diastolic blood pressure by periodically measuring the second time difference T_D and, computing an estimated diastolic blood pressure, P_D, from the time difference, T_D, using the multi-parameter equation and the second plurality of constant parameters.

12. The method of claim 9 wherein measuring the first time difference comprises maximizing a cross-correlation between the first and second pulse signals.

13. The method of claim 12 wherein, in measuring the first time difference, portions of the first and second pulse signals below a first threshold are not considered.

14. The method of claim 13 wherein the threshold for the first pulse signal is an average value of the first pulse signal and the threshold for the second pulse signal is an average value of the second pulse signal.

15. A method for estimating a blood pressure of a subject, the method comprising:

a) detecting a first pulse signal at a first location;

b) detecting a second pulse signal at a second location;

c) determining an elapsed times, T, between the arrival of corresponding points of the first and second pulse signals; and

,

d) computing an estimated blood pressure, P, from the elapsed time by performing the calculation;

16. The method of claim 15 wherein the corresponding points are peaks of the pulse signals.

17. The method of claim 15 wherein the corresponding points are valleys of the pulse signals.

18. The method of claim 15 wherein determining the elapsed time comprises computing a cross-correlation of the first pulse signal and the second pulse signal.

19. The method of claim 18 comprising performing a calibration by taking a reference blood pressure reading to obtain a reference blood pressure P₀ and measuring the elapsed time T₀ corresponding to the reference blood pressure and performing the calculations:

$a=c_1+\frac{c_2<br><br>\left(P_0-c_1\right)}{\ln <br><br>\left(T_0\right)+c_2}$$\mathrm{and},<br><br>b=\frac{P_0-c_1}{\ln <br><br>\left(T_0\right)+c_2}$

or calculations substantially equivalent thereto to obtain values for the parameters a and b.

20. The method of claim 18 comprising performing a calibration by taking a reference blood pressure reading to obtain a reference blood pressure P₀ and measuring the elapsed time T₀ corresponding to the reference blood pressure and performing the calculations:

21. A method for estimating the blood pressure, P, of a subject, the method comprising:

a) detecting a first pulse signal at a first location on the subject;

b) detecting a second pulse signal at a second location on the subject;

c) performing a calibration by measuring the subject'"'"'s blood pressure P₀ and measuring a corresponding elapsed time, T₀, between the arrival of corresponding points of the first and second pulse signals;

d) subsequently monitoring the subject'"'"'s blood pressure by determining an elapsed time, T, between the arrival of corresponding points of the first and second pulse signals; and

,

e) calculating an estimated blood pressure, P, based on the value;

$\frac{\left(P_0-c_1\right)}{\left(\ln <br><br>\left(T_0\right)+C_2\right)}$

 

where c₁ and a₂ are constants.

22. The method of claim 21 wherein calculating the estimated blood pressure comprises performing the computation:

$P=c_1+\frac{c_2<br><br>\left(P_0-c_1\right)}{\ln <br><br>\text{\hspace{1em}<br><br>}<br><br>\left(T_0\right)+c_2}+\frac{P_0-c_1}{\ln <br><br>\text{\hspace{1em}<br><br>}<br><br>\left(T_0\right)+c_2}<br><br>\ln <br><br>\text{\hspace{1em}<br><br>}<br><br>\left(T\right)$

or a substantially mathematically equivalent computation.

23. The method of claim 22 wherein c₁ is about 85.41, and c₂ is about −

4.73 for systolic pressure measurements.

24. The method of claim 23 wherein c₁ is about 49.36 and c₂ is about −

4.3 for diastolic pressure measurements.

25. The method of claim 23 wherein c₁ is in the range of 85±

10 and c₂ is in the range of −

4.7±

1 for systolic pressure measurements.

26. The method of claim 23 wherein c₁ is in the range of 50±

10 and c₂ is in the range of −

4.3±

1 for diastolic pressure measurements.

27. The method of claim 23 where c₁ and c2 are derived by:

for several subjects, at each of two or more times, measuring a reference blood pressure value P₀ and a corresponding elapsed time, T₀, between corresponding points of the first and second pulse signals;

for each of the subjects determining best fit values for a and b such that;

28. A method for estimating the blood pressure, P, of a subject, the method comprising:

a) detecting a first pulse signal at a first location on the subject;

b) detecting a second pulse signal at a second location on the subject;

c) performing a calibration by measuring the subject'"'"'s blood pressure P₀ and measuring a corresponding elapsed time, T₀, between the arrival of corresponding points of the first and second pulse signals;

d) subsequently monitoring the subject'"'"'s blood pressure by determining an elapsed time, T, between the arrival of corresponding points of the first and second pulse signals; and

,

f) calculating and estimated blood pressure, P, substantially according to the equation;

29. The method of claim 28 wherein c₃ is about −

0.4381 and c₄ is about −

9.1247 for systolic pressure measurements.

30. The method of claim 28 wherein c₃ is about −

0.2597 and c₄ is about −

4.3789 for diastolic pressure measurements.

31. The method of claim 28 wherein c₃ is in the range of −

0.4381±

0.1 and c₄ is in the range of −

9.1247±

1.2 for systolic pressure measurements.

32. The method of claim 28 wherein c₃ is in the range of −

0.2597±

0.1 and c₄ is in the range of −

4.3789±

1.0 for diastolic pressure measurements.

33. The method of claim 28 where c₃ and c₄ are derived by:

for several subjects, at each of two or more times, measuring a reference blood pressure value P₀ and a corresponding elapsed time, T₀, between corresponding points of first and second pulse signals detected at first and second locations on the subject;

for each of the subjects determining best fit values for a and b such that;

34. Apparatus for estimating a blood pressure of a subject, the apparatus comprising:

a) a computer processor;

b) an input for receiving a first signal corresponding to a pulse signal detected at a first location;

c) an input for receiving a second signal corresponding to the pulse signal detected at a second location;

d) a program store containing computer software comprising instructions which, when run on the processor cause the processor to measure an elapsed time, T, between corresponding points on the first and second signals and compute an estimated blood pressure, P, from the elapsed time by performing the calculation;

35. The apparatus of claim 34 wherein the corresponding points correspond to the valleys of the pulse signals for a diastolic blood pressure estimation.

36. The apparatus of claim 34 wherein the corresponding points correspond to the peaks of the pulse signals for a systolic blood pressure estimation.

37. The apparatus of claim 34 wherein the software comprises a set of instructions which cause the computer processor to compute a cross-correlation of the first and second signals.

38. The apparatus of claim 37 comprising an input for receiving a reference signal indicative of a reference blood pressure value.

39. Apparatus for estimating a blood pressure of a subject, the apparatus comprising:

a) signal detection means for detecting first and second pulse signals;

b) correlation means for determining an elapsed time, T, between the first and second pulse signals;

c) computation means for computing an estimated blood pressure, P, from the elapsed time according to a non-linear function which is generally decreasing and concave upward in a manner specified by two or more settable parameters; and

,

d) calibration means for receiving a reference blood pressure and associating the reference blood pressure with an elapsed time determined by the correlation means; and

,

e) means responsive to the calibration means for establishing values for the two or more settable parameters from the reference blood pressure and elapsed time.

40. The apparatus of claim 39 wherein the non-linear function is monotonical decreasing.

41. The apparatus of claim 39 wherein the calculation means performs the calculation:

42. The apparatus of claim 39 wherein the correlation means determines separate first and second time differences T_S and T_D respectively from higher and lower portions of the first and second pulse signals respectively.

43. The apparatus of claim 42 wherein the computation means comprises diastolic blood pressure computation means for computing a diastolic blood pressure from the first time difference and systolic blood pressure computation means for computing a systolic blood pressure from the second time difference.

44. The apparatus of claim 39 wherein the correlation means comprises a buffer for holding a segment of the first pulse signal, a buffer for holding a segment of the second pulse signal and a processor executing instructions which cause the processor to determine a time difference for which a cross correlation between the segment of the first pulse signal and the segment of the second pulse signal is maximized.

45. The apparatus of claim 44 wherein the correlation means determines separate first and second time differences T_S and T_D respectively from higher and lower portions of the first and second pulse signals respectively.

46. The apparatus of claim 45 wherein the correlation means comprises means for computing an average value of each of the first and second pulse signals and the higher portions comprise portions having a value in excess of the average value.

47. The apparatus of claim 44 wherein the correlation means comprises means for creating from the first and second pulse signals a first set of modified signals p₁(t) and p₂(t) which include the peaks of the first and second pulse signals but do not include valleys of the first and second pulse signals and the correlation means determines a first time difference T_S by determining a time shift which yields a maximum correlation between signals of the first set of modified signals.

48. A program product comprising a medium bearing computer-readable signals, the signals containing instructions which, when executed on a computer processor, cause the computer processor to perform a method for monitoring blood pressure, the method comprising:

a) detecting a first pulse signal at a first location on a subject and detecting a second pulse signal at a second location on the subject;

b) measuring a reference blood pressure P₀ and a corresponding time difference T₀ between the first and second pulse signals;

c) from the reference blood pressure and corresponding time difference, determining a first plurality of constant parameters in a multi-parameter equation relating blood pressure and the time-difference;

d) monitoring the subject'"'"'s blood pressure by periodically measuring a time difference T between the first and second pulse signals; and

,

e) computing an estimated blood pressure, P, from the time difference, T, using the multi-parameter equation and the first plurality of constant parameters.

49. A method for obtaining a value representing a blood pressure of a subject, the method comprising:

measuring a reference blood pressure P₀ and determining a corresponding reference time difference, T₀ by at least;

receiving a first pulse signal detected at a first location on the subject;

receiving a second pulse signal detected at a second location on the subject; and

,

determining the reference time difference, T₀, by measuring a time shift between corresponding points of the first and second pulse signals;

based upon the reference blood pressure and the reference time difference, obtaining a non-linear function relating blood pressure and time difference for the subject; and

,

at one or more subsequent times, computing an estimated blood pressure, P, by at least;

at the one or more subsequent times, determining a time difference, T, between corresponding points of the first and second pulse signals and computing the non-linear function of the time difference

wherein obtaining the non-linear function comprises determining at least two parameters of the non-linear function.

50. The method of claim 49 wherein obtaining the non-linear function comprises determining a first one of the at least two parameters as a predetermined function of the reference time difference.

51. The method of claim 50 wherein obtaining the non-linear function comprises determining a second one of the at least two parameters based upon the first one of the at least two parameters the reference blood pressure and the reference time difference.

52. The method of claim 51 wherein the non-linear function comprises a logarithmic function of T and, in the non-linear function, the logarithmic function of T is multiplied by the first one of the parameters.

53. The method of claim 52 wherein, the non-linear function comprises adding the second one of the parameters to a result.

54. The method of claim 51 wherein obtaining the first parameter comprises performing the calculation

55. The method of claim 54 wherein obtaining the second parameter comprises performing the calculation:

56. The method of claim 50 wherein the predetermined function is a function obtained by:

collecting multiple pairs of reference time difference and reference blood pressure for each of a plurality of reference subjects;

for each of the plurality of reference subjects fitting the non-linear function to the multiple pairs of reference time difference and reference blood pressure to obtain values for the first and second parameters for each of the plurality of reference subjects; and

,

fitting a suitable curve to obtain the predetermined function.

57. The method of claim 56 wherein the suitable curve comprises a linear trend line.

58. The method of claim 57 wherein the plurality of reference subjects is selected by picking reference subjects for whom a measure of fit between the non-linear function and the multiple pairs of reference time difference and reference blood pressure exceeds a threshold.

59. The method of claim 58 wherein the measure of fit comprises an R-squared value.

60. A method for obtaining a value representing a blood pressure of a subject, the method comprising:

measuring a reference blood pressure P₀ and determining a corresponding reference time difference, T₀ by at least;

receiving a first pulse signal detected at a first location on the subject;

receiving a second pulse signal detected at a second location on the subject; and

,

determining the reference time difference, T₀, by measuring a time shift between corresponding points of the first and second pulse signals;

based upon the reference blood pressure and the reference time difference, obtaining a non-linear function relating blood pressure and time difference for the subject; and

,

at one or more subsequent times, computing an estimated blood pressure, P, by at least;

at the one or more subsequent times, determining a time difference, T, between corresponding points of the first and second pulse signals and computing the non-linear function of the time difference

wherein the non-linear function comprises a logarithmic function of T.

61. A method for obtaining a value representing a blood pressure of a subject, the method comprising:

measuring a reference blood pressure P₀ and determining a corresponding reference time difference, T₀ by at least;

receiving a first pulse signal detected at a first location on the subject;

receiving a second pulse signal detected at a second location on the subject; and

,

determining the reference time difference, T₀, by measuring a time shift between corresponding points of the first and second pulse signals;

based upon the reference blood pressure and the reference time difference, obtaining a non-linear function relating blood pressure and time difference for the subject; and

,

at one or more subsequent times, computing an estimated blood pressure, P, by at least;

at the one or more subsequent times, determining a time difference, T, between corresponding points of the first and second pulse signals and computing the non-linear function of the time difference

wherein the value representing a blood pressure of a subject represents a systolic blood pressure of the subject and the corresponding points on the first and second signals are in parts of the first and second signals corresponding to a systolic portion of the subject'"'"'s pulse.

62. A method for obtaining a value representing a blood pressure of a subject, the method comprising:

measuring a reference blood pressure P₀ and determining a corresponding reference time difference, T₀ by at least;

receiving a first pulse signal detected at a first location on the subject;

receiving a second pulse signal detected at a second location on the subject; and

,

determining the reference time difference, T₀, by measuring a time shift between corresponding points of the first and second pulse signals;

based upon the reference blood pressure and the reference time difference, obtaining a non-linear function relating blood pressure and time difference for the subject; and

,

at one or more subsequent times, computing an estimated blood pressure, P, by at least;

at the one or more subsequent times, determining a time difference, T, between corresponding points of the first and second pulse signals and computing the non-linear function of the time difference

wherein the non-linear function comprises a logarithmic function of T.

63. A method for obtaining a value representing a blood pressure of a subject, the method comprising:

measuring a reference blood pressure P₀ and determining a corresponding reference time difference, T₀ by at least;

receiving a first pulse signal detected at a first location on the subject;

receiving a second pulse signal detected at a second location on the subject; and

,

determining the reference time difference, T₀, by measuring a time shift between corresponding points of the first and second pulse signals;

based upon the reference blood pressure and the reference time difference, obtaining a non-linear function relating blood pressure and time difference for the subject; and

,

at one or more subsequent times, computing an estimated blood pressure, P, by at least;

at the one or more subsequent times, determining a time difference, T, between corresponding points of the first and second pulse signals and computing the non-linear function of the time difference

wherein the value representing a blood pressure of a subject represents a systolic blood pressure of the subject and the corresponding points on the first and second signals are in parts of the first and second signals corresponding to a systolic portion of the subject'"'"'s pulse.