Optimization of pacemaker settings with R-wave detection

• US 9,220,903 B2
• Filed: 12/16/2014
• Issued: 12/29/2015
• Est. Priority Date: 12/16/2013
• Status: Active Grant

• Current Assignee: Atcor Medical Pty Ltd (CardieX Ltd.)
• Original Assignee: Atcor Medical Pty Ltd (CardieX Ltd.)
• Inventors: Naqvi, Tasneem Z., Winter, Dean C.
• Primary Examiner(s): Patton, Amanda
• Application Number:
  US14/571,884
• Publication Number:
  US 20150165211A1
• Time in Patent Office: 378 Days
• US Class Current: 1/1
• CPC Class Codes: A61B 5/02028 Determining haemodynamic parameters not otherwise provided for, e.g. cardiac contractility or left ventricular ejection fraction
• CPC Class Codes: A61B 5/349 Detecting specific parameters of the electrocardiograph cycle
• CPC Class Codes: A61N 1/36564 controlled by blood pressure
• CPC Class Codes: A61N 1/36585 controlled by two or more physical parameters
• CPC Class Codes: A61N 1/36842 Multi-site stimulation in the same chamber
• CPC Class Codes: A61N 1/36843 Bi-ventricular stimulation

Abstract

The system provides information to facilitate efficient optimization of programmer settings for cardiac pacemakers. It simultaneously measures a patient'"'"'s electrocardiogram and peripheral blood pressure (or volumetric displacement) waveform in order to calculate, in real-time and non-invasively, a value correlated to the pre-ejection time (PET) and, optionally, ejection duration (ED) for the patient'"'"'s left ventricle. The peripheral pulse waveform can be monitored with a wrist mounted tonometer, or a suitable brachial cuff device. The time difference between the occurrence of the R-wave on the ECG trace and the foot of the pulse on the radial blood pressure waveform is defined as a surrogate pre-ejection time interval (SPET). Data including the electrocardiogram and peripheral pulse trace, as well as the calculated, surrogate pre-ejection time interval (SPET) for each heart beat and trending is displayed on a computer monitor, thereby allowing a physician or nurse to quickly optimize PET for the patient and adjust programmer settings for an implanted pacemaker.

Claims

1. A method of optimizing one or more programmer settings of a cardiac pacemaker comprising the steps of:

attending to a patient with a cardiac pacemaker having one or more programmable settings;

measuring the electrical activity of a heart of the patient in the form of an electrocardiogram which plots a sensed voltage difference between electrodes placed noninvasively in the patient'"'"'s skin as a function of time, for each pulse of the heart, the electrocardiogram being characterized in part by a QRS complex having an R-wave;

simultaneously using a sensor to measure a peripheral pulse waveform of the patient as a function of time;

for each respective pulse, determining from the electrocardiogram the R-wave of the QRS complex and defining a time corresponding to the R-wave as an R-wave impulse time (T_R) for a contracting ventricle;

for each respective pulse, determining the realization of systolic onset in the detected peripheral pulse waveform and defining the corresponding time as a peripherally measured systolic onset time (T₂) for the pulse;

using T_R and T₂ to calculate an R-wave surrogate pre-ejection time interval SPET for the pulse;

presenting information related to the calculated R-wave surrogate pre-ejection interval (SPET); and

adjusting one or more of the programmable settings for the cardiac pacemaker in an effort to optimize the value of the calculated surrogate pre-ejection time interval SPET for the patient.

2. A method of optimizing one or more programmer settings of a cardiac pacemaker as recited in claim 1 further comprising the steps of:

for each respective pulse, determining the time (T₄) corresponding to the realization of the closing of the aortic valve in the peripheral pulse waveform;

using T₄ and T₂ to calculate an ejection duration time (ED) for the patient;

presenting information relating to the calculated ejection duration time (ED); and

further adjusting one or more of the programmer settings for the cardiac pacemaker in an effort to optimize the value of the ejection duration (ED) for the patient.

3. A method of optimizing one or more programmer settings of a cardiac pacemaker as recited in claim 2 wherein the determined time T₄ for the closing of the aortic valve in the peripheral pulse wave is determined by taking the third derivative of the peripheral pulse wave and identifying the first positive to negative zero crossing following the largest maximum after a second shoulder in the peripheral pulse wave unless a second shoulder cannot be identified, in which case the first positive to negative zero crossing following the largest maximum point of the third derivative after the first shoulder.

4. A method of optimizing one or more programmer settings of a cardiac pacemaker as recited in claim 2 further comprising the step of calculating and displaying the ratio

5. A method of optimizing one or more programmer settings of a cardiac pacemaker as recited in claim 1 wherein the settings are adjusted in an effort to minimize the value of the surrogate pre-ejection time interval SPET.

6. A method of optimizing one or more programmer settings of a cardiac pacemaker as recited in claim 1 wherein the step of determining an R-wave impulse time (T_R) comprises determining a peak value of the voltage difference in the QRS complex of the electrocardiogram for each respective pulse.

7. A method of optimizing one or more programmer settings of a cardiac pacemaker as recited in claim 1 wherein the peripheral pulse waveform is a radial artery pressure waveform measured by a tonometer.

8. A method of optimizing one or more programmer settings of a cardiac pacemaker as recited in claim 7 wherein the tonometer is strapped to the wrist of the patient in a fixed location to sense the pressure in the patient'"'"'s radial artery.

9. A method of optimizing one or more programmer settings of a cardiac pacemaker as recited in claim 1 wherein the peripheral pulse waveform is a brachial volumetric waveform measured by a cuff on the patient'"'"'s upper arm.

10. A method of optimizing one or more programmer settings of a cardiac pacemaker as recited in claim 1 wherein a mean value for the surrogate pre-ejection time interval SPET is calculated as the average difference between the determined R-wave impulse time T_R and the determined peripheral systolic onset time T₂ for a series of pulses and is presented.

11. A method of optimizing one or more programmer settings of a cardiac pacemaker as recited in claim 1 wherein the onset of systole in the measured peripheral pulse waveform is determined by analyzing the first derivative of the peripheral pulse waveform and identifying a first negative to positive zero crossing preceding a maximum value for the first derivative.

12. A method of optimizing one or more programmer settings of a cardiac pacemaker as recited in claim 1 wherein the cardiac pacemaker is a biventricular cardiac pacemaker.

13. A system to facilitate optimization of programmable cardiac pacemaker settings during cardiac resynchronization therapy, the system comprising:

a blood pressure sensor adapted to detect a peripheral pulse waveform of a cardiac pacemaker patient;

an electrocardiogram unit having electrodes that are placed on the patient, the ECG unit measuring the electrical activity of the patient'"'"'s heart in the form of an electrocardiogram which is, for each pulse of the heart, characterized in part by a QRS complex;

a screen display; and

a computer processor programmed with software to implement the following steps;

for each respective pulse on the electrocardiogram, determining the time corresponding to the R-wave of the QRS complex and defining the corresponding time as an R-wave impulse time (T_R) for a contracting ventricle;

for each respective pulse, determining systolic onset of the detected peripheral pulse wave and defining the corresponding time as a peripherally measured systolic onset time (T₂) for the pulse;

using (T_R) and (T₂) to calculate a surrogate pre-ejection time interval SPET; and

displaying information on the screen relating to the calculated surrogate pre-ejection time interval SPET.

14. A system as recited in claim 13 wherein the blood pressure sensor is a tonometer.

15. A system as recited in claim 14 wherein the tonometer is mounted to a strap adapted to hold the tonometer against the wrist of a patient in a fixed location to monitor the patient'"'"'s radial artery.

16. A system as recited in claim 13 wherein the blood pressure sensor is a brachial cuff.

17. A system as recited in claim 13 wherein the computer processor is contained within a personal computer onto which the software is loaded;

and the system further comprises a digital signal processing electronic module which is electrically connected to the blood pressure sensor and to leads for the ECG electrodes, and provides analog data for the electrocardiogram and the peripheral pulse waveform that is transmitted to an analog to digital converter which provides digital data in real-time to the personal computer.

18. A system as recited in claim 13 wherein the computer processor is programmed with software to implement the following steps:

for each respective pulse on the electrocardiogram, determining the time corresponding to the Q-wave of the QRS complex and defining the corresponding time as an Q-wave impulse time (T₀) for a contracting ventricle;

for each respective pulse, determining systolic onset of the detected peripheral pulse wave and defining the corresponding time as a peripherally measured systolic onset time (T₂) for the pulse;

using (T₀) and (T₂) to calculate an alternative surrogate pre-ejection time interval SPET (Q-wave); and

providing an option for a user to select to display information on the screen relating to the calculated alternative surrogate pre-ejection time interval SPET (Q-wave).

19. A system as recited in claim 13 further comprising a screen display, and further wherein the software displays information on the screen relating to the surrogate pre-ejection time interval SPET.

20. A system as recited in claim 19 wherein the software further analyzes ECG data and peripheral pulse waveform data collected over a fixed time period and calculates averages of the SPET for the heart beats within the fixed time period as well as a standard deviation of SPET for the heart beats in the fixed time period.

21. A system as recited in claim 20 wherein the screen display further comprises a data selection window that enables the user to select or deselect data to be used in calculating an average surrogate pre-ejection time interval SPET for a given time period.

22. A system as recited in claim 13 wherein the personal computer is capable of storing patient electrocardiogram and peripheral pulse waveform data for later analysis.

23. A system as recited in claim 13 wherein the software provides a graphical representation on the screen display of the patient electrocardiogram data and the patient peripheral waveform data, both as a function of time.

24. A system as recited in claim 13 wherein the computer is programmed to determine systolic onset of the detected peripheral pulse waveform by analyzing a first derivative of the peripheral pulse waveform and identifying a first negative to positive zero crossing preceding a maximum value for the first derivative.

25. A system as recited in claim 18 further comprising a screen display, and further wherein the software is capable of displaying information on the screen relating to the surrogate pre-ejection time interval SPET and the alternative pre-ejection time interval SPET (Q-wave).

26. A system as recited in claim 25 wherein the software further analyzes ECG data and peripheral pulse waveform data collected over a fixed time period and calculates averages of the SPET for the heart beats within the fixed time period as well as a standard deviation of SPET for the heart beats in the fixed time period, and further calculates averages of the alternative SPET (Q-wave) for the heart beats within the fixed time period as well as a standard the alternative SPET (Q-wave) for the heart beats in the fixed time period.

27. A system as recited in claim 26 wherein the screen display further comprises a data selection window that enables the user to select or deselect data to be used in calculating an average surrogate pre-ejection time interval SPET for a given time period and alternatively enables the user to select or deselect data to be used in calculating an average alternative SPET (Q-wave) for a given time period.