Continuous calibration of a blood pressure measurement device

• US 10,039,455 B2
• Filed: 05/18/2015
• Issued: 08/07/2018
• Est. Priority Date: 05/19/2014
• Status: Active Grant

• Current Assignee: Philips Healthcare Informatics Incorporated (Koninklijke Philips N.V.)
• Original Assignee: Qualcomm, Inc.
• Inventors: Lading, Lars, Baek, David Boettcher
• Primary Examiner(s): Fernandez, Katherine
• Assistant Examiner(s): IMPINK, BRADLEY GERALD
• Application Number:
  US14/714,966
• Publication Number:
  US 20150327785A1
• Time in Patent Office: 1,177 Days
• Field of Search: None
• CPC Class Codes: A61B 2560/0223 of calibration, e.g. protocols for calibrating sensors
• CPC Class Codes: A61B 2560/0238 Means for recording calibration data
• CPC Class Codes: A61B 2560/0242 adapted to measure environmental factors, e.g. temperature, pollution
• CPC Class Codes: A61B 2560/0247 for compensation or correction of the measured physiological value
• CPC Class Codes: A61B 2562/0214 Capacitive electrodes
• CPC Class Codes: A61B 2562/0219 Inertial sensors, e.g. accelerometers, gyroscopes, tilt switches
• CPC Class Codes: A61B 5/0059 using light, e.g. diagnosis by transillumination, diascopy, fluorescence A61B5/0093, A61B5/1455, A61B5/02416 and A61B5/0261 take precedence
• CPC Class Codes: A61B 5/0082 adapted for particular medical purposes
• CPC Class Codes: A61B 5/02007 Evaluating blood vessel condition, e.g. elasticity, compliance
• CPC Class Codes: A61B 5/021 Measuring pressure in heart or blood vessels A61B5/0205 takes precedence
• CPC Class Codes: A61B 5/02108 from analysis of pulse wave characteristics
• CPC Class Codes: A61B 5/02116 of pulse wave amplitude A61B5/02225 takes precedence
• CPC Class Codes: A61B 5/053 Measuring electrical impedance or conductance of a portion of the body
• CPC Class Codes: A61B 5/0535 Impedance plethysmography for measuring blood flow A61B5/0295
• CPC Class Codes: A61B 5/1075 for measuring dimensions by non-invasive methods, e.g. for determining thickness of tissue layer A61B8/0858 takes precedence
• CPC Class Codes: A61B 5/1126 using a particular sensing technique
• CPC Class Codes: A61B 5/6898 Portable consumer electronic devices, e.g. music players, telephones, tablet computers
• CPC Class Codes: A61B 5/725 using specific filters therefor, e.g. Kalman or adaptive filters A61B5/316 take precedence
• CPC Class Codes: A61B 5/726 using Wavelet transforms
• CPC Class Codes: A61B 5/7275 Determining trends in physiological measurement data; Predicting development of a medical condition based on physiological measurements, e.g. determining a risk factor
• CPC Class Codes: A61B 5/7278 : Artificial waveform generation or derivation, e.g. synthesising signals from measured signals A61B5/327 takes precedence
• CPC Class Codes: A61B 5/7282 : Event detection, e.g. detecting unique waveforms indicative of a medical condition A61B5/4094, A61B5/4818, A61B5/349, A61B5/0823 take precedence
• CPC Class Codes: A61B 5/7285 : for synchronising or triggering a physiological measurement or image acquisition with a physiological event or waveform, e.g. an ECG signal A61B6/5205, A61B6/541, A61B8/5207, A61B8/543 take precedence
• CPC Class Codes: A61B 8/04 : Measuring blood pressure

Abstract

Systems, methods, and devices of the various embodiments enable continuous non-invasive monitoring of blood pressure with a minimum of interference. The various embodiments may provide a method for adaptation for the calibration for continuous measurements of blood pressure, wherein the measured quantity may be related to an arterial lumen or arterial cross sectional area comprising calibrating the conversion for incremental variations of arterial properties and absolute value adaptation by exploitation of the exponential decay during the diastole. In various embodiments, continuous calibration of a non-interfering blood pressure measurement device may be initiated based on a change in mean arterial pressure being greater than a threshold value, such as a pressure value associated with an actual measured distension of a patient'"'"'s artery.

Claims

1. A method for calibration of a non-interfering blood pressure measurement device, comprising:

determining, by a processor, a pulse rate, a distension, a hydrostatic pressure, and an elevation at an artery of a patient at two observation times, wherein the pulse rate, the hydrostatic pressure, and the distension are determined based on a collection of outputs of an arterial measurement sensor of the non-interfering blood pressure measurement device and the elevation is determined based on one or more outputs of an elevation sensor of the non-interfering blood pressure measurement device;

determining, by the processor, a series of arterial pressures of the artery of the patient between the two observation times based on the collection of outputs of the arterial measurement sensor;

determining, by the processor, whether a change in both the distension and the elevation occurred between the two observation times;

determining, by the processor, whether a change in the pulse rate has occurred between the two observation times in response to determining that the change in both the distension and the elevation occurred between the two observation times;

determining, by the processor, an incremental variation between the two observation times in response to determining that no change in the pulse rate occurred between the two observation times, wherein the incremental variation is a change in hydrostatic pressure between the two observation times over the change in the distension between the two observation times;

determining, by the processor, an exponentially decaying function representing an exponential decay of the series of arterial pressures in a portion of a diastolic phase of a selected pulse that occurred between the two observation times;

determining, by the processor, a mean arterial pressure based at least in part on the exponentially decaying function and the incremental variation;

determining, by the processor, whether a change in mean arterial pressure determined as a difference between the determined mean arterial pressure and a previously determined mean arterial pressure is greater than a threshold pressure; and

calibrating, by the processor, the non-interfering blood pressure measurement device in response to determining that the change in mean arterial pressure is greater than the threshold pressure, wherein calibrating the non-interfering blood pressure measurement device comprises controlling, by the processor, the non-interfering blood pressure measurement device to enter a calibration mode.

2. The method of claim 1, wherein determining, by the processor, the mean arterial pressure based at least in part on the exponentially decaying function and the incremental variation comprises:

determining, by the processor, a diastolic pressure based on the exponentially decaying function and the incremental variation;

determining, by the processor, a systolic blood pressure based at least in part on the determined diastolic pressure; and

determining, by the processor, the mean arterial pressure as two thirds of the determined diastolic pressure added to one third of the determined systolic blood pressure.

3. The method of claim 1, wherein the arterial measurement sensor is one or more of a bioimpedance sensor, impedance plethysmography sensor, photoplethsmography sensor, ultrasound sensor, and surface pressure sensor.

4. The method of claim 1, wherein calibrating the non-interfering blood pressure measurement device includes updating calibration values stored in a memory of the non-interfering blood pressure measurement device based on the change in mean arterial pressure and the change in distension.

5. The method of claim 1, wherein determining, by the processor, whether the change in the pulse rate has occurred between the two observation times comprises localizing, by the processor, pulses that occurred between the two observation times by one or more of:

determining a zero crossing of a high-pass filter demodulated signal;

localizing maximum pulse gradients;

localizing based on a quantity related to the maximum and minimum of each pulse; and

wavelet filtering to extract shape and time information.

6. A device, comprising:

a processor in communication with a non-interfering blood pressure measurement device, wherein the processor is configured with processor executable instructions to perform operations to;

determine a pulse rate, a distension, a hydrostatic pressure, and an elevation at an artery of a patient at two observation times, wherein the pulse rate, the hydrostatic pressure, and the distension are determined based on a collection of outputs of an arterial measurement sensor of the non-interfering blood pressure measurement device and the elevation is determined based on one or more outputs of an elevation sensor of the non-interfering blood pressure measurement device;

determine a series of arterial pressures of the artery of the patient between the two observation times based on the collection of outputs of the arterial measurement sensor;

determine whether a change in both the distension and the elevation occurred between the two observation times;

determine whether a change in the pulse rate has occurred between the two observation times in response to determining that the change in both the distension and the elevation occurred between the two observation times;

determine an incremental variation between the two observation times in response to determining that no change in the pulse rate occurred between the two observation times, wherein the incremental variation is a change in hydrostatic pressure between the two observation times over the change in the distension between the two observation times;

determine an exponentially decaying function representing an exponential decay of the series of arterial pressures in a portion of a diastolic phase of a selected pulse that occurred between the two observation times;

determine a mean arterial pressure based at least in part on the exponentially decaying function and the incremental variation;

determine whether a change in mean arterial pressure determined as a difference between the determined mean arterial pressure and a previously determined mean arterial pressure is greater than a threshold pressure; and

calibrate the non-interfering blood pressure measurement device in response to determining that the change in mean arterial pressure is greater than the threshold pressure, wherein calibrating the non-interfering blood pressure measurement device comprises controlling the non-interfering blood pressure measurement device to enter a calibration mode.

7. The device of claim 6, wherein the processor is configured with processor executable instructions to perform operations to determine the mean arterial pressure based at least in part on the exponentially decaying function and the incremental variation by:

determining a diastolic pressure based on the exponentially decaying function and the incremental variation;

determining a systolic blood pressure based at least in part on the determined diastolic pressure; and

determining the mean arterial pressure as two thirds of the determined diastolic pressure added to one third of the determined systolic blood pressure.

8. The device of claim 6, wherein the arterial measurement sensor is one or more of a bioimpedance sensor, impedance plethysmography sensor, photoplethsmography sensor, ultrasound sensor, and surface pressure sensor.

9. The device of claim 6, wherein the processor is further configured with processor executable instructions to perform operations to calibrate the non-interfering blood pressure measurement device by updating calibration values stored in a memory of the non-interfering blood pressure measurement device based on the change in mean arterial pressure and the change in distension.

10. The device of claim 6, wherein the processor is configured with processor executable instructions to perform operations to determine whether the change in the pulse rate has occurred between the two observation times by localizing pulses that occurred between the two observation times by one or more of:

determining a zero crossing of a high-pass filter demodulated signal;

localizing maximum pulse gradients;

localizing based on a quantity related to the maximum and minimum of each pulse; and

wavelet filtering to extract shape and time information.

11. A non-interfering blood pressure measurement device, comprising:

an arterial measurement sensor;

an elevation sensor; and

a processor connected to the arterial measurement sensor and elevation sensor, wherein the processor is configured with processor executable instructions to perform operations to;

determine a pulse rate, a distension, a hydrostatic pressure, and an elevation at an artery of a patient at two observation times, wherein the pulse rate, the hydrostatic pressure, and the distension are determined based on a collection of outputs of the arterial measurement sensor and the elevation is determined based on one or more outputs of the elevation sensor;

determine a series of arterial pressures of the artery of the patient between the two observation times based on the collection of outputs of the arterial measurement sensor;

determine whether a change in both the distension and the elevation occurred between the two observation times;

determine whether a change in the pulse rate has occurred between the two observation times in response to determining that the change in both the distension and the elevation occurred between the two observation times;

determine an incremental variation between the two observation times in response to determining that no change in the pulse rate occurred between the two observation times, wherein the incremental variation is a change in hydrostatic pressure between the two observation times over the change in the distension between the two observation times;

determine an exponentially decaying function representing an exponential decay of the series of arterial pressures in a portion of a diastolic phase of a selected pulse that occurred between the two observation times;

determine a mean arterial pressure based at least in part on the exponentially decaying function and the incremental variation;

determine whether a change in mean arterial pressure determined as a difference between the determined mean arterial pressure and a previously determined mean arterial pressure is greater than a threshold pressure; and

calibrate the non-interfering blood pressure measurement device in response to determining that the change in mean arterial pressure is greater than the threshold pressure, wherein calibrating the non-interfering blood pressure measurement device comprises controlling the non-interfering blood pressure measurement device to enter a calibration mode.

12. The non-interfering blood pressure measurement device of claim 11, wherein the processor is configured with processor executable instructions to perform operations to determine the mean arterial pressure based at least in part on the exponentially decaying function and the incremental variation by:

determining a diastolic pressure based on the exponentially decaying function and the incremental variation;

determining a systolic blood pressure based at least in part on the determined diastolic pressure; and

determining the mean arterial pressure as two thirds of the determined diastolic pressure added to one third of the determined systolic blood pressure.

13. The non-interfering blood pressure measurement device of claim 11, wherein the arterial measurement sensor is one or more of a bioimpedance sensor, impedance plethysmography sensor, photoplethsmography sensor, ultrasound sensor, and surface pressure sensor.

14. The non-interfering blood pressure measurement device of claim 11, wherein the processor is further configured with processor executable instructions to perform operations to calibrate the non-interfering blood pressure measurement device by updating calibration values stored in a memory of the non-interfering blood pressure measurement device based on the change in mean arterial pressure and the change in distension.

15. The non-interfering blood pressure measurement device of claim 11, wherein the processor is configured with processor executable instructions to perform operations to determine whether the change in the pulse rate has occurred between the two observation times by localizing pulses that occurred between the two observation times by one or more of:

determining a zero crossing of a high-pass filter demodulated signal;

localizing maximum pulse gradients;

localizing based on a quantity related to the maximum and minimum of each pulse; and

wavelet filtering to extract shape and time information.

16. A device, comprising:

means for determining a pulse rate, a distension, a hydrostatic pressure, and an elevation at an artery of a patient at two observation times, wherein the pulse rate, the hydrostatic pressure, and the distension are determined based on a collection of outputs of an arterial measurement sensor of a non-interfering blood pressure measurement device and the elevation is determined based on one or more outputs of an elevation sensor of the non-interfering blood pressure measurement device;

means for determining, by the processor, a series of arterial pressures of the artery of the patient between the two observation times based on the collection of outputs of the arterial measurement sensor;

means for determining whether a change in both the distension and the elevation occurred between the two observation times;

means for determining whether a change in the pulse rate has occurred between the two observation times in response to determining that the change in both the distension and the elevation occurred between the two observation times;

means for determining an incremental variation between the two observation times in response to determining that no change in the pulse rate occurred between the two observation times, wherein the incremental variation is a change in hydrostatic pressure between the two observation times over the change in the distension between the two observation times;

means for determining an exponentially decaying function representing an exponential decay of the series of arterial pressures in a portion of a diastolic phase of a selected pulse that occurred between the two observation times;

means for determining a mean arterial pressure based at least in part on the exponentially decaying function and the incremental variation;

means for determining whether a change in mean arterial pressure determined as a difference between the determined mean arterial pressure and a previously determined mean arterial pressure is greater than a threshold pressure; and

means for calibrating the non-interfering blood pressure measurement device in response to determining that the change in mean arterial pressure is greater than the threshold pressure, wherein means for calibrating the non-interfering blood pressure measurement device comprises means for controlling the non-interfering blood pressure measurement device to enter a calibration mode.

17. The device of claim 16, wherein means for determining the mean arterial pressure based at least in part on the exponentially decaying function and the incremental variation comprises:

means for determining a diastolic pressure based on the exponentially decaying function and the incremental variation;

means for determining a systolic blood pressure based at least in part on the determined diastolic pressure; and

means for determining the mean arterial pressure as two thirds of the determined diastolic pressure added to one third of the determined systolic blood pressure.

18. The device of claim 16, wherein the arterial measurement sensor is one or more of a bioimpedance sensor, impedance plethysmography sensor, photoplethsmography sensor, ultrasound sensor, and surface pressure sensor.

19. The device of claim 16, wherein means for calibrating the non-interfering blood pressure measurement device further comprises means for updating calibration values stored in a memory of the non-interfering blood pressure measurement device based on the change in mean arterial pressure and the change in distension.

20. The device of claim 16, wherein means for determining whether the change in the pulse rate has occurred between the two observation times comprises means for localizing pulses that occurred between the two observation times by one or more of:

determining a zero crossing of a high-pass filter demodulated signal;

localizing maximum pulse gradients;

localizing based on a quantity related to the maximum and minimum of each pulse; and

wavelet filtering to extract shape and time information.

21. A non-transitory processor readable medium having stored thereon processor executable instructions configured to cause a processor to perform operations comprising:

determining a pulse rate, a distension, a hydrostatic pressure, and an elevation at an artery of a patient at two observation times, wherein the pulse rate, the hydrostatic pressure, and the distension are determined based on a collection of outputs of an arterial measurement sensor of the non-interfering blood pressure measurement device and the elevation is determined based on one or more outputs of an elevation sensor of the non-interfering blood pressure measurement device;

determining a series of arterial pressures of the artery of the patient between the two observation times based on the collection of outputs of the arterial measurement sensor;

determining, whether a change in both the distension and the elevation occurred between the two observation times;

determining whether a change in the pulse rate has occurred between the two observation times in response to determining that the change in both the distension and the elevation occurred between the two observation times;

determining an incremental variation between the two observation times in response to determining that no change in the pulse rate occurred between the two observation times, wherein the incremental variation is a change in hydrostatic pressure between the two observation times over the change in the distension between the two observation times;

determining an exponentially decaying function representing an exponential decay of the series of arterial pressures in a portion of a diastolic phase of a selected pulse that occurred between the two observation times;

determining a mean arterial pressure based at least in part on the exponentially decaying function and the incremental variation;

determining whether a change in mean arterial pressure determined as a difference between the determined mean arterial pressure and a previously determined mean arterial pressure is greater than a threshold pressure; and

means for calibrating the non-interfering blood pressure measurement device in response to determining that the change in mean arterial pressure is greater than the threshold pressure, wherein calibrating the non-interfering blood pressure measurement device comprises controlling the non-interfering blood pressure measurement device to enter a calibration mode.

22. The non-transitory processor readable medium of claim 21, wherein the stored processor readable instructions are configured to cause a processor to perform operations such that determining the mean arterial pressure based at least in part on the exponentially decaying function and the incremental variation comprises:

determining a diastolic pressure based on the exponentially decaying function and the incremental variation;

determining a systolic blood pressure based at least in part on the determined diastolic pressure; and

determining the mean arterial pressure as two thirds of the determined diastolic pressure added to one third of the determined systolic blood pressure.

23. The non-transitory processor readable medium of claim 21, wherein the stored processor readable instructions are configured to cause a processor to perform operations such that the arterial measurement sensor is one or more of a bioimpedance sensor, impedance plethysmography sensor, photoplethsmography sensor, ultrasound sensor, and surface pressure sensor.

24. The non-transitory processor readable medium of claim 21, wherein the stored processor readable instructions are configured to cause a processor to perform operations such that calibrating the non-interfering blood pressure measurement device further comprises updating, by the processor, calibration values stored in a memory of the non-interfering blood pressure measurement device based on the change in mean arterial pressure and the change in distension.

25. The non-transitory processor readable medium of claim 21, wherein the stored processor readable instructions are configured to cause a processor to perform operations such that determining whether the change in the pulse rate has occurred between the two observation times comprises localizing pulses that occurred between the two observation times by one or more of:

determining a zero crossing of a high-pass filter demodulated signal;

localizing maximum pulse gradients;

localizing based on a quantity related to the maximum and minimum of each pulse; and

wavelet filtering to extract shape and time information.

26. A system, comprising:

a non-interfering blood pressure measurement device; and

a computing device, comprising a processor in communication with the non-interfering blood pressure measurement device, wherein the processor is configured with processor executable instructions to perform operations to;

determine a pulse rate, a distension, a hydrostatic pressure, and an elevation at an artery of a patient at two observation times, wherein the pulse rate, the hydrostatic pressure, and the distension are determined based on a collection of outputs of an arterial measurement sensor of the non-interfering blood pressure measurement device and the elevation is determined based on one or more outputs of an elevation sensor of the non-interfering blood pressure measurement device;

determine a series of arterial pressures of the artery of the patient between the two observation times based on the collection of outputs of the arterial measurement sensor;

determine whether a change in both the distension and the elevation occurred between the two observation times;

determine whether a change in the pulse rate has occurred between the two observation times in response to determining that the change in both the distension and the elevation occurred between the two observation times;

determine an incremental variation between the two observation times in response to determining that no change in the pulse rate occurred between the two observation times, wherein the incremental variation is a change in hydrostatic pressure between the two observation times over the change in the distension between the two observation times;

determine an exponentially decaying function representing an exponential decay of the series of arterial pressures in a portion of a diastolic phase of a selected pulse that occurred between the two observation times;

determine a mean arterial pressure based at least in part on the exponentially decaying function and the incremental variation;

determine whether a change in mean arterial pressure determined as a difference between the determined mean arterial pressure and a previously determined mean arterial pressure is greater than a threshold pressure; and

calibrate the non-interfering blood pressure measurement device in response to determining that the change in mean arterial pressure is greater than the threshold pressure, wherein calibrating the non-interfering blood pressure measurement device comprises controlling the non-interfering blood pressure measurement device to enter a calibration mode.

27. The system of claim 26, wherein the processor is configured with processor executable instructions to perform operations to determine the mean arterial pressure based at least in part on the exponentially decaying function and the incremental variation by:

determining a diastolic pressure based on the exponentially decaying function and the incremental variation;

determining a systolic blood pressure based at least in part on the determined diastolic pressure; and

determining the mean arterial pressure as two thirds of the determined diastolic pressure added to one third of the determined systolic blood pressure.

28. The system of claim 26, wherein the arterial measurement sensor is one or more of a bioimpedance sensor, impedance plethysmography sensor, photoplethsmography sensor, ultrasound sensor, and surface pressure sensor.

29. The system of claim 26, wherein the processor is further configured with processor executable instructions to perform operations to calibrate the non-interfering blood pressure measurement device by updating calibration values stored in a memory of the non-interfering blood pressure measurement device based on the change in mean arterial pressure and the change in distension.

30. The system of claim 26, wherein the processor is configured with processor executable instructions to perform operations to determine whether the change in the pulse rate has occurred between the two observation times by localizing pulses that occurred between the two observation times by one or more of:

determining a zero crossing of a high-pass filter demodulated signal;

localizing maximum pulse gradients;

localizing the pulses based on a quantity related to the maximum and minimum of each pulse; and

wavelet filtering to extract shape and time information.