Body-worn system for measuring continuous non-invasive blood pressure (cNIBP)

• US 9,161,700 B2
• Filed: 12/30/2009
• Issued: 10/20/2015
• Est. Priority Date: 06/12/2007
• Status: Active Grant

• Current Assignee: Sotera Wireless Incorporated
• Original Assignee: Sotera Wireless Incorporated
• Inventors: Banet, Matt, Dhillon, Marshal, McCombie, Devin
• Primary Examiner(s): D'Angelo, Michael
• Assistant Examiner(s): WEARE, MEREDITH H
• Application Number:
  US12/650,374
• Publication Number:
  US 20100160794A1
• Time in Patent Office: 2,120 Days
• Field of Search: 600322-341, 600481-507
• US Class Current: 1/1
• CPC Class Codes: A61B 5/0022 Monitoring a patient using a global network, e.g. telephone networks, internet
• CPC Class Codes: A61B 5/02125 of pulse wave propagation time
• CPC Class Codes: A61B 5/02133 by using induced vibration of the blood vessel
• CPC Class Codes: A61B 5/0225 the pressure being controlled by electric signals, e.g. derived from Korotkoff sounds
• CPC Class Codes: A61B 5/02416 using photoplethysmograph signals, e.g. generated by infrared radiation A61B5/14552 takes precedence
• CPC Class Codes: A61B 5/0295 using plethysmography, i.e. measuring the variations in the volume of a body part as modified by the circulation of blood therethrough, e.g. impedance plethysmography
• CPC Class Codes: A61B 5/1118 Determining activity level
• CPC Class Codes: A61B 5/14551 for measuring blood gases
• CPC Class Codes: A61B 5/318 Heart-related electrical modalities, e.g. electrocardiography [ECG]
• CPC Class Codes: A61B 5/349 Detecting specific parameters of the electrocardiograph cycle
• CPC Class Codes: A61B 5/6824 Arm or wrist
• CPC Class Codes: A61B 5/721 using a separate sensor to detect motion or using motion information derived from signals other than the physiological signal to be measured
• CPC Class Codes: A61B 5/7239 using differentiation including higher order derivatives
• CPC Class Codes: A61B 5/742 using visual displays A61B5/339 takes precedence

Abstract

The present invention provides a technique for continuous measurement of blood pressure based on pulse transit time and which does not require any external calibration. This technique, referred to herein as the ‘Composite Method’, is carried out with a body-worn monitor that measures blood pressure and other vital signs, and wirelessly transmits them to a remote monitor. A network of body-worn sensors, typically placed on the patient'"'"'s right arm and chest, connect to the body-worn monitor and measure time-dependent ECG, PPG, accelerometer, and pressure waveforms. The disposable sensors can include a cuff that features an inflatable bladder coupled to a pressure sensor, three or more electrical sensors (e.g. electrodes), three or more accelerometers, a temperature sensor, and an optical sensor (e.g., a light source and photodiode) attached to the patient'"'"'s thumb.

Claims

1. A method for body worn monitoring a blood pressure value from a patient who may be ambulatory, comprising using a body-worn system including a microprocessor capable of continuous non-invasive blood pressure monitoring for:

(a) detecting a time-dependent optical waveform comprising a pulse induced by the patient'"'"'s heartbeat with an optical sensor configured to attach to the patient;

(b) detecting a time-dependent electrical waveform comprising a QRS complex induced by the patient'"'"'s heartbeat with an electrical sensor configured to attach to the patient;

(c) determining a pulse transit time, which is a measure of a separation in time between a portion of the pulse comprised by the time-dependent optical waveform and a portion of the QRS complex comprised by the time-dependent electrical waveform;

(d) determining a heart rate from portions of QRS complexes in the time-dependent electrical waveform;

(e) determining a mathematical relationship between heart rate, or a first parameter calculated therefrom, and pulse transit time, or a second parameter calculated therefrom;

(f) determining an estimated pulse transit time from a heart rate and the mathematical relationship between heart rate and pulse transit time; and

(g) analyzing the estimated pulse transit time and a patient-specific slope value (m) relating pulse transit time to mean arterial blood pressure, wherein m is determined from a pressure-dependent indexing blood pressure measurement made during inflation of an arm-worn blood pressure cuff that comprises an inflatable bladder and an internal pressure sensor, to determine a blood pressure value from the patient.

2. The method of claim 1, wherein step (e) further comprises measuring a first set of heart rate values and a second set of pulse transit time values, and processing the first and second sets to determine the mathematical relationship.

3. The method of claim 2, wherein the first and second sets are measured prior to measuring the heart rate used in step (f) to determine the estimated pulse transit time.

4. The method of claim 3, wherein the first and second sets are measured over a time period ranging between 5 and 60 seconds.

5. The method of claim 2, wherein step (e) further comprises analyzing paired values of heart rate and pulse transit time determined from the first and second sets with a mathematical function to determine the mathematical relationship.

6. The method of claim 5, wherein step (e) further comprises fitting the paired values determined from the first and second sets with a numerical fitting algorithm to determine the mathematical relationship.

7. The method of claim 6, wherein the numerical fitting algorithm is a linear regression algorithm.

8. The method of claim 7, wherein the mathematical relationship comprises a linear relationship relating heart rate to pulse transit time.

9. The method of claim 1, wherein the mathematical relationship comprises a non-linear relationship.

10. The method of claim 1, wherein prior to step (f), the method comprises an analysis step for analyzing a pulse in the time-dependent optical waveform.

11. The method of claim 10, wherein the analysis step comprises evaluating a signal quality characterizing the pulse to determine if an accurate pulse transit time can be calculated therefrom.

12. The method of claim 1, wherein prior to step (f), the method comprises a motion analysis step for analyzing at least one motion waveform.

13. The method of claim 12, wherein the motion analysis step comprises evaluating the motion waveform to determine if an accurate pulse transit time can be calculated from the pulse in the optical waveform and the QRS complex in the electrical waveform.

14. The method of claim 13, wherein the motion analysis step comprises comparing a portion of the motion waveform to a predetermined threshold to determine if an accurate pulse transit time can be calculated from the pulse in the optical waveform and the QRS complex in the electrical waveform.

15. The method of claim 13, wherein the motion analysis step comprises comparing a portion of the motion waveform to a mathematical motion model to determine if an accurate pulse transit time can be calculated from the pulse in the optical waveform and the QRS complex in the electrical waveform.

16. The method of claim 12, wherein an accelerometer generates the at least one motion waveform.

17. The method of claim 16, wherein the accelerometer is configured to attach to the patient.

18. A method for monitoring a blood pressure value from a patient who may be ambulatory, comprising using a body-worn system including a microprocessor capable of continuous non-invasive blood pressure monitoring to:

(a) detect a time-dependent optical waveform comprising a pulse induced by the patient'"'"'s heartbeat with an optical sensor configured to attach to the patient;

(b) detect a time-dependent electrical waveform comprising a QRS complex induced by the patient'"'"'s heartbeat with an electrical sensor configured to attach to the patient;

(c) determine a pulse transit time which is a measure of a separation in time between a portion of the pulse comprised by the time-dependent optical waveform and a portion of the QRS complex comprised by the time-dependent electrical waveform;

(d) determine a heart rate from portions of QRS complexes in the time-dependent electrical waveform;

(e) determine a mathematical relationship between heart rate, or a first parameter calculated therefrom, and pulse transit time, or a second parameter calculated therefrom;

(f) determine that a pulse in the time-dependent optical waveform is not adequate to determine a pulse transit time;

(g) determine an estimated pulse transit time from a heart rate and the mathematical relationship between heart rate and pulse transit time; and

(h) analyze the estimated pulse transit time and a patient-specific slope value (m) relating pulse transit time to mean arterial blood pressure, wherein m is determined from a pressure-dependent indexing blood pressure measurement made during inflation of an arm-worn blood pressure cuff that comprises an inflatable bladder and an internal pressure sensor to determine a blood pressure value from the patient.