Pulse Wave Velocity-to-Blood Pressure Calibration Prompting

• US 20170119264A1
• Filed: 12/29/2015
• Published: 05/04/2017
• Est. Priority Date: 11/04/2015
• Status: Abandoned Application

• Current Assignee: Lacamas Life Sciences, Inc.
• Original Assignee: Sharp Laboratories of America Incorporated (Hon Hai Precision Industry Co., Ltd.)
• Inventors: Hill, Fredrick
• Application Number:
  US14/983,348
• Publication Number:
  US 20170119264A1
• Time in Patent Office: Days
• CPC Class Codes: A61B 2560/0223 of calibration, e.g. protocols for calibrating sensors
• CPC Class Codes: A61B 5/02125 of pulse wave propagation time
• CPC Class Codes: A61B 5/02416 using photoplethysmograph signals, e.g. generated by infrared radiation A61B5/14552 takes precedence
• CPC Class Codes: A61B 5/352 Detecting R peaks, e.g. for synchronising diagnostic apparatus; Estimating R-R interval
• CPC Class Codes: A61B 5/7221 Determining signal validity, reliability or quality A61B5/7207 and A61B5/7217 take precedence
• CPC Class Codes: A61B 5/7253 characterised by using transforms
• CPC Class Codes: G01L 27/005 Apparatus for calibrating pressure sensors

Abstract

A system and method are provided for prompting blood pressure-related calibrations. The method relies on statistical hypothesis tests over a current measurement and an accumulated set of calibration points to determine whether the benefit of calibration, in terms of calibration diversity, outweighs the cost to the patient. The algorithm uses statistical methods to predict calibration effect without actually performing the calibration, hence, reducing the calibration ‘cost’ to the patient and increasing the diversity of calibration points and thereby improving PWV-BP transform quality. The method is applicable to both manual and automatic calibration modes.

Claims

1. A method for prompting blood pressure (BP)-related calibrations, the method comprising:

creating a transform comprising a calibration set including a plurality of sample pairs, where each sample pair includes a mean measurement of pulse wave velocity (PWV) correlated to a measured reference blood pressure value, where each mean PWV measurement is derived from a plurality of PWV observations;

performing a current mean PWV measurement;

performing a model utility test comparing an estimated slope of the transform to an estimated standard deviation of the slope (Test

     1);

when a null hypothesis of the model utility test is rejected, performing a first normalized mean difference test comparing a current blood pressure estimate with a mean calibration reference blood pressure over the calibration set (Test

     2); and

,

when a null hypothesis of the first normalized mean difference test is rejected, prompting a calibration of the transform, where the calibration includes augmenting the calibration set with actual BP measurements correlated to the current mean PWV measurement.

2. The method of claim 1 further comprising:

when the null hypothesis of the model utility test is not rejected, performing a second normalized mean difference test comparing the mean of the PWV over the calibration set with the current mean PWV measurement (Test

     0); and

,

when the null hypothesis of the second mean difference test is rejected, prompting a calibration of the transform.

3. The method of claim 1 wherein performing the model utility test (Test 1) includes finding a test statistic value of t less than a first predetermined value,

4. The method of claim 3 wherein the estimated standard deviation of the slope (S_{{circumflex over (β}

)}₁) is calculated as;

5. The method of claim 1 wherein performing the first normalized mean difference test (Test 2) includes finding the difference between the mean calibration reference blood pressure and the current blood pressure estimate normalized by a standard deviation product over the calibration set.

6. The method of claim 5 wherein Test 2 finds a test statistic (t) as follows:

7. The method of claim 2 wherein performing the second normalized mean difference test (Test 0) includes finding the difference between the current PWV estimate and the mean PWV over the calibration set normalized by a PWV standard deviation product.

8. The method of claim 7 wherein Test 0 finds a test statistic (t) as follows:

9. The method of claim 2 wherein performing the first normalized mean difference test (Test 2) includes adjusting a confidence threshold of the first normalized mean difference test as a function of time since a last-occurring previous calibration;

and,

wherein performing the second normalized mean difference test (Test

     0) includes adjusting a confidence threshold of the second normalized mean difference test as a function of time since a last-occurring previous calibration.

10. The method of claim 2 wherein performing the model utility test (Test 1) includes deleting oldest elements of the calibration set as a function of time since a last-occurring previous calibration;

wherein performing the first normalized mean difference test (Test

     2) includes deleting oldest elements of the calibration set as a function of time since the last-occurring previous calibration; and

,

wherein performing the second normalized mean difference test (Test

     0) includes deleting oldest elements of the calibration set as a function of time since the last-occurring previous calibration.

11. A system for prompting blood pressure (BP)-related calibrations, the system comprising:

a PWV measurement interface comprising an electrocardiogram (ECG) sensor and a photoplethysmography (PPG) sensor for measuring ECG and PPG signals;

a processor;

a non-transitory memory including;

a transform file comprising a calibration set including a plurality of sample pairs, where each sample pair includes a mean measurement of pulse wave velocity (PWV) correlated to a measured reference blood pressure values, where each mean PWV measurement is derived from a plurality of PWV observations;

a prompting application enabled as a sequence of processor instructions for accepting a current mean PWV measurement, performing a model utility test comparing a difference between an estimated slope of the transform and its hypothesis value to an estimated standard deviation of the slope (Test

     1), and when a null hypothesis of the model utility test is rejected, performing a first normalized mean difference test comparing a current blood pressure estimate with a mean calibration reference blood pressure over the calibration set (Test

     2), and when a null hypothesis of the first normalized mean difference test is rejected, prompting a transform calibration.

12. The system of claim 11 further comprising:

a BP measurement interface comprising a BP cuff for measuring BP signals; and

,

wherein the prompting application accepts BP measurements in response to prompting the transform calibration, and modifies the transform by augmenting the calibration set with actual BP measurements correlated to current mean PWV measurements.

13. The system of claim 12 wherein the prompting application performs a second normalized mean difference test when the null hypothesis of the model utility test is not rejected, comparing the mean of the PWV over the calibration set with the current mean PWV measurement (Test 0), and when the null hypothesis of the second mean difference test is rejected, prompting a calibration of the transform.

14. The system of claim 12 wherein the prompting application performs the model utility test (Test 1) by finding a test statistic value of t less than a first predetermined value,

15. The system of claim 14 wherein the prompting application calculates the estimated standard deviation of the slope (S_{{circumflex over (β}

)}₁) as follows;

16. The system of claim 12 wherein the prompting application performs the first normalized mean difference test (Test 2) by finding the difference between the mean calibration reference blood pressure and the current blood pressure estimate normalized by a standard deviation product over the calibration set.

17. The system of claim 16 wherein the prompting application performs Test 2 by finding a test statistic (t) as follows:

18. The system of claim 13 wherein the prompting application performs the second normalized mean difference test (Test 0) by finding the difference between the current PWV estimate and the mean PWV over the calibration set normalized by a PWV standard deviation product.

19. The system of claim 18 wherein the prompting application performs Test 0 by finding a test statistic (t) as follows:

20. The system of claim 13 wherein the prompting application performs the first normalized mean difference test (Test 2) by adjusting a confidence threshold of the first normalized mean difference test as a function of time since a last-occurring previous calibration;

and,

wherein the prompting application performs the second normalized mean difference test (Test

     0) by adjusting diminishing a confidence threshold of the second normalized mean difference test as a function of time since a last-occurring previous calibration.

21. The system of claim 13 wherein the prompting application performs the model utility test (Test 1) by deleting oldest elements of the calibration set as a function of time since a last-occurring previous calibration;

wherein the prompting application performs the first normalized mean difference test (Test

     2) by deleting oldest elements of the calibration set as a function of time since the last-occurring previous calibration; and

,

wherein the prompting application performs the second normalized mean difference test (Test

     0) by deleting oldest elements of the calibration set as a function of time since the last-occurring previous calibration.