OPTIMIZATION OF PACEMAKER SETTINGS

• US 20100228311A1
• Filed: 03/04/2009
• Published: 09/09/2010
• Est. Priority Date: 03/04/2009
• Status: Active Grant

• Current Assignee: Atcor Medical Pty Ltd (CardieX Ltd.)
• Original Assignee: Atcor Medical Pty Ltd (CardieX Ltd.)
• Inventors: Naqvi, Tasneem Zehra, Winter, Dean Carl
• Granted Patent: US 8,112,150 B2
• Time in Patent Office: Days
• US Class Current: 607/18
• CPC Class Codes: A61B 5/02233 Occluders specially adapted therefor tourniquets A61B17/132
• CPC Class Codes: A61B 5/349 Detecting specific parameters of the electrocardiograph cycle
• CPC Class Codes: A61B 5/7239 using differentiation including higher order derivatives
• CPC Class Codes: A61N 1/3627 for treating a mechanical deficiency of the heart, e.g. congestive heart failure or cardiomyopathy
• CPC Class Codes: A61N 1/36507 controlled by gradient or slope of the heart potential
• CPC Class Codes: A61N 1/36564 controlled by blood pressure
• CPC Class Codes: A61N 1/36585 controlled by two or more physical parameters

Abstract

The system provides information to facilitate efficient optimization of programmer settings for cardiac pacemakers. It uses simultaneous measurement of a patient'"'"'s electrocardiogram and peripheral blood pressure waveform in order to calculate, in real-time, a value correlated to the patient'"'"'s pre-ejection time (PET) and, optionally, ejection duration (ED) for the patient'"'"'s left ventricle. The peripheral blood pressure waveform is preferably monitored with a wrist mounted tonometer. Data including the electrocardiogram and peripheral blood pressure trace, as well as the 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 adjusting 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 Q-wave;

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

for each respective pulse, determining from the electrocardiogram a Q-wave and defining a corresponding time as an initial impulse time (T₀) for a contracting ventricle;

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

using T₀ and T₂ to calculate a surrogate pre-ejection time interval SPET for the pulse; and

adjusting one or more of the programmable settings for the cardiac pacemaker in an effort to optimize the value of the 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 pressure waveform;

using T₄ and T₂ to calculate an ejection duration time (ED) for the patient; 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 further comprising the step of:

calculating and displaying the ratio SPET/ED.

4. 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.

5. A method of optimizing one or more programmer settings of a cardiac pacemaker as recited in claim 1 wherein the step of determining an initial impulse time (T₀) correlating to the Q-wave comprises determining a minimum value of the voltage difference in the Q-wave of the electrocardiogram for each respective pulse.

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 impulse time (T₀) for a contracting ventricle comprises the step of determining the onset of the QRS complex in the electrocardiogram for the respective pulse.

7. A method of optimizing one or more programmer settings of a cardiac pacemaker as recited in claim 1 wherein the peripheral pressure 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 pressure waveform is a brachial pressure 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 initial contraction time T₀ and the determined peripheral systolic onset time T₂ for a series of pulses.

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 pressure waveform is determined by analyzing the first derivative of the peripheral pressure 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 method of optimizing one or more programmer settings of a cardiac pacemaker as recited in claim 5 wherein the minimum value of the voltage difference in the Q-wave for the electrocardiogram is determined by:

analyzing the electrocardiogram waveform to;

identify a largest peak in the electrocardiogram which corresponds to the peak of the R-wave in the electrocardiogram; and

then identifying a minimum value of the waveform prior to the identified peak in the R-wave of the electrocardiogram.

14. 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 pressure wave is determined by taking the third derivative of the peripheral pressure wave and identifying the first positive to negative zero crossing following the largest maximum after a second shoulder in the peripheral pressure 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.

15. 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 pressure 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 Q-wave; and

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

for each respective pulse, determining from the electrocardiogram Q-wave and defining the corresponding time as an initial impulse time (T₀) for a contracting ventricle;

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

using (T₀) and (T₂) to calculate a surrogate pre-ejection time interval SPET.

16. A system as recited in claim 15 wherein the blood pressure sensor is a tonometer.

17. A system as recited in claim 16 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.

18. A system as recited in claim 15 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 pressure waveform that is transmitted to an analog to digital converter which provides digital data in real-time to the personal computer.

19. A system as recited in claim 15 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 pressure 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 15 wherein the personal computer is capable of storing patient electrocardiogram and peripheral pressure waveform data for later analysis.

22. A system as recited in claim 17 wherein the software provides a graphical representation on the screen display of the patient electrocardiogram data and the patient peripheral blood pressure waveform data, both as a function of time.

23. A system as recited in claim 15 wherein the computer is programmed to determine systolic onset of the detected peripheral pressure waveform by analyzing a first derivative of the peripheral pressure waveform and identifying a first negative to positive zero crossing preceding a maximum value for the first derivative.