SYSTEMS AND METHODS FOR MONITORING DP, IVRT, DiFT, DIASTOLIC FUNCTION AND/OR HF

• US 20100228136A1
• Filed: 05/29/2009
• Published: 09/09/2010
• Est. Priority Date: 03/04/2009
• Status: Active Grant

• Current Assignee: Pacesetter Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Pacesetter Incorporated (Abbott Laboratories Incorporated)
• Inventors: Keel, Allen J., Wenzel, Brian Jeffrey, Hou, Wenbo, Karst, Edward, Farazi, Taraneh Ghaffari
• Granted Patent: US 8,428,698 B2
• Time in Patent Office: Days
• US Class Current: 600/507
• CPC Class Codes: A61B 5/02416 using photoplethysmograph signals, e.g. generated by infrared radiation A61B5/14552 takes precedence
• CPC Class Codes: A61B 5/318 Heart-related electrical modalities, e.g. electrocardiography [ECG]
• CPC Class Codes: A61B 5/6846 specially adapted to be brought in contact with an internal body part, i.e. invasive

Abstract

Implantable systems, and methods for use therewith, are provided for monitoring a patient'"'"'s diastolic function and/or heart failure (HF) condition. A signal indicative of changes in arterial blood volume and a signal indicative of electrical activity of the patient'"'"'s heart are obtained. Beginnings of diastolic periods can be detected based on a feature of the signal indicative of changes in arterial blood volume. Ends of the diastolic periods can be detected based on a feature of the signal indicative of electrical activity of the patient'"'"'s heart, or on the signal indicative of changes in arterial blood volume. Diastolic periods (DPs), isovolumic relaxation times (IVRTs) and/or diastolic filling times (DiFTs) can be estimated based on the detected beginnings of the diastolic periods and detected ends of the diastolic periods. The patient'"'"'s diastolic function and/or HF condition (and/or changes therein) can be monitored based on the estimates of DP, IVRT and/or DiFT.

Claims

1. For use with an implantable system, a method comprising:

(a) using an implanted sensor to obtain a signal indicative of changes in a patient'"'"'s arterial blood volume for a period of time corresponding to one or more cardiac cycles;

(b) using implanted electrodes to obtain a signal indicative of electrical activity of the patient'"'"'s heart for the period of time;

(c) detecting a beginning of a diastolic period (DP) based on a feature of the signal indicative of changes in arterial blood volume;

(d) detecting an end of the DP based on a feature of the signal indicative of electrical activity of the patient'"'"'s heart; and

(e) estimating the DP, an isovolumic relaxation time (IVRT) and/or a diastolic filling time (DiFT) based on the beginning of the DP as detected at step (c) and the end of the DP as detected at step (d).

2. The method of claim 1, wherein step (e) includes:

estimating the DP by determining a time between the beginning of the DP as detected at step (c) and the end of the DP as detected at step (d).

3. The method of claim 2, wherein step (e) includes estimating DP using one of the following:

estimating the DP as being equal to the time between the beginning of the DP as detected at step (c) and the end of the DP as detected at step (d);

or

estimating the DP as being equal to the time between the beginning of the DP as detected at step (c) and the end of the DP as detected at step (d) plus an offset that compensates for the implanted sensor being used at step (a) not being located within the patient'"'"'s heart.

4. The method of claim 2, wherein step (e) includes:

estimating the patient'"'"'s IVRT based on the estimated DP.

5. The method of claim 4, wherein step (e) includes estimating the patient'"'"'s IVRT using the equation IVRT=X*DP, where 0<

X<

1.

6. The method of claim 5, wherein X is a predetermined constant.

7. The method of claim 5, where X is variable, and wherein step (e) includes estimating X based on at least one feature of at least one of the following signals:

the signal indicative of changes in arterial blood volume obtained at step (a) and used at step (c) to detect the beginning of the diastolic period; and

a further signal indicative of mechanical activity of the patient'"'"'s heart.

8. The method of claim 1, further comprising:

repeating steps (a), (b), (c), (d) and (e) from time to time; and

monitoring changes in the patient'"'"'s diastolic function and/or HF condition by monitoring changes in the patient'"'"'s DP, IVRT and/or DiFT as steps (a), (b), (c), (d) and (e) are repeated from time to time.

9. The method of claim 8, wherein the step of monitoring changes in the patient'"'"'s diastolic function and/or HF condition comprises:

detecting a worsening of the patient'"'"'s diastolic function and/or HF condition if the patient'"'"'s IVRT increases over time; and

detecting an improvement in the patient'"'"'s diastolic function and/or HF condition if the patient'"'"'s IVRT decreases over time.

10. The method of claim 9, wherein the step of monitoring changes in the patient'"'"'s diastolic function and/or HF condition comprises:

determining a short term average IVRT and a long term average IVRT as steps (a), (b), (c), (d) and (e) are repeated from time to time; and

detecting a worsening of the patient'"'"'s diastolic function if the short term average IVRT increases above a specified percentage of the long term average IVRT.

11. The method of claim 1, wherein step (e) includes estimating the patient'"'"'s IVRT;

and further comprising categorizing the patient'"'"'s diastolic function, based on the estimated IVRT, as follows;

categorizing the patient'"'"'s diastolic function as normal if the estimated IVRT≦

a first threshold;

categorizing the patient'"'"'s diastolic function as mild diastolic dysfunction if the first threshold<

the estimated IVRT≦

a second threshold; and

categorizing the patient'"'"'s diastolic function as severe diastolic dysfunction if the estimated IVRT>

the second threshold.

12. The method of claim 1, wherein:

step (a) comprises using an implanted photoplethysmography (PPG) to obtain a PPG signal indicative of changes in arterial blood volume for the period of time corresponding to one or more cardiac cycles;

step (b) comprises using implanted electrodes to obtain an intracardiac electrogram (IEGM) or electrocardiogram (ECG) signal indicative of electrical activity of the patient'"'"'s heart for the period of time;

step (c) comprises detecting the beginning of the DP by detecting a dicrotic notch of the PPG signal;

step (d) comprises detected the end of the DP by detecting a ventricular depolarization in the ECG or IEGM that is closest in time following the dicrotic notch detected at step (c).

13. The method of claim 12, further comprising:

(f) determining the maximum downward slope of the PPG signal following the dicrotic notch to thereby estimate a surrogate of left ventricular (LV) relaxation rate; and

(g) determining the patient'"'"'s diastolic function based on the surrogate of LV relaxation rate determined at step (f) and the IVRT estimated at step (e).

14. The method of claim 12, wherein:

steps (a), (b), (c), (d) and (e) are performed at a first heart rate (HR) and a second HR that is greater than the first HR to thereby determine

the DP corresponding to the first HR (DP₁),

a peak-to-peak amplitude of the PPG signal corresponding to the first HR (Peak₁),

the DP corresponding to the second HR (DP₂), and

a peak-to-peak amplitude of the PPG signal corresponding to the second HR (Peak₂); and

further comprising monitoring the patient'"'"'s hemodynamic condition based on DP₁, Peak₁, DP₂ and Peak₂.

15. The method of claim 14, wherein the step of monitoring the patient'"'"'s hemodynamic condition comprises:

determining a difference in peak-to-peak amplitudes (DiffPeak) using the equation DiffPeak=Peak₂−

Peak₁;

determining a difference in DPs (DiffDiFT) using the equation DiffDP=DP₁−

DP₂;

determining a ratio DiffPeak/DiffDP; and

monitoring the patient'"'"'s hemodynamic condition based on the ratio DiffPeak/DiffDP.

16. The method of claim 14, wherein the step of monitoring the patient'"'"'s hemodynamic condition comprises:

calculating DP₁/Peak₁−

DP₂/Peak₂; and

monitoring the patient'"'"'s hemodynamic condition based on results of the calculation.

17. The method of claim 1, wherein

step (a) comprises using an implanted photoplethysmography (PPG) sensor to obtain a PPG signal;

step (e) comprises estimating the patient'"'"'s DP by determining a time between the beginning of the diastolic period as detected at step (c) and the end of the diastolic period as detected at step (d), and optionally adding an offset that compensates for the PPG sensor being used at step (a) not being located within the patient'"'"'s heart; and

further comprising;

(f) using implanted electrodes to obtain a cardiogenic impedance (CI) signal for the period of time; and

(g) estimating a change in the patient'"'"'s ventricular blood volume by determining a change in the amplitude of the CI signal from the beginning of the DP as detected at step (c) to the end of the DP as detected at step (d); and

(h) estimating the patient'"'"'s ventricular relaxation rate (VRR) using the equation VRR=change in patient'"'"'s ventricular blood volume/DP.

18. The method of claim 17, wherein steps (a) through (g) are performed at an intrinsic heart rate (HR) and an increased HR resulting from an exercise protocol, so that the patient'"'"'s VRR is estimated at the intrinsic HR and the increased HR resulting from the exercise protocol;

and

further comprising determining the patient'"'"'s exercise tolerance based on the estimated VRR at the intrinsic HR and the estimated VRR at the increased HR resulting from the exercise protocol.

19. For use with an implantable system, a method for monitoring a patient'"'"'s diastolic function and/or heart failure (HF) condition, comprising:

obtaining a signal indicative of changes in arterial blood volume and a signal indicative of electrical activity of the patient'"'"'s heart;

detecting

beginnings of diastolic periods based on a feature of the signal indicative of changes in arterial blood volume, and

ends of the diastolic periods based on a feature of the signal indicative of electrical activity of the patient'"'"'s heart; and

estimating the patient'"'"'s diastolic periods (DPs), isovolumic relaxation times (IVRTs) and/or diastolic filling times (DiFTs) based on the detected beginnings of the diastolic periods and detected ends of the diastolic periods; and

monitoring the patient'"'"'s diastolic function and/or HF, and/or changes in the patient'"'"'s diastolic function and/or HF, based on estimates of DP, IVRT and/or DiFT.

20. The method of claim 19, wherein the monitoring step comprises monitoring changes in the patient'"'"'s diastolic function and/or HF based on changes in the estimates of DP, IVRT and/or DiFT.

21. An implantable system, comprising:

an implantable sensor to obtain a signal indicative of changes in arterial blood volume;

a sensing circuit to obtain a signal indicative of electrical activity of the patient'"'"'s heart;

a monitor configured to

detect beginnings of diastolic periods based on a feature of the signal indicative of changes in arterial blood volume,

detect ends of the diastolic periods based on a feature of the signal indicative of electrical activity of the patient'"'"'s heart, and

estimate diastolic periods (DPs), isovolumic relaxation times (IVRTs) and/or diastolic filling times (DiFTs) based on the detected beginnings of the diastolic periods and the detected ends of the diastolic periods.

22. The implantable system of claim 21, wherein the monitor is also configured to monitor the patient'"'"'s diastolic function and/or HF condition based on estimates of DP, IVRT and/or DiFT.

23. The implantable system of claim 21, wherein the monitor is also configured to monitor changes in the patient'"'"'s diastolic function and/or HF condition based on estimates of DP, IVRT and/or DiFT.

24. For use with an implantable system, a method comprising:

(a) using an implanted sensor to obtain a signal indicative of changes in a patient'"'"'s arterial blood volume for a period of time corresponding to one or more cardiac cycles;

(b) detecting a beginning of a diastolic period (DP) based on a first feature of the signal indicative of changes in arterial blood volume;

(c) detecting an end of the DP based on a second feature of the signal indicative of changes in arterial blood volume; and

(d) estimating the DP, an isovolumic relaxation time (IVRT) and/or a diastolic filling time (DiFT) based on the beginning of the DP as detected at step (b) and the end of the DP as detected at step (c).

25. The method of claim 24, wherein:

step (a) comprises using an implanted photoplethysmography (PPG) sensor to obtain a PPG signal indicative of changes in arterial blood volume for the period of time corresponding to one or more cardiac cycles;

step (b) comprises detecting the beginning of a DP by detecting a dicrotic notch of the PPG signal;

step (c) comprises detected the end of the DP by detecting a foot of the PPG signal following the dicrotic notch detected at step (b); and

step (d) comprises estimating the DP by determining a time between the beginning of the DP as detected at step (b) and the end of the DP as detected at step (c).

26. An implantable system, comprising:

an implantable sensor to obtain a plethysmography signal indicative of changes in arterial blood volume;

a monitor configured to

detect beginnings and ends of diastolic periods based on features of the plethysmography signal indicative of changes in arterial blood volume, and

estimate diastolic periods (DPs), isovolumic relaxation times (IVRTs) and/or diastolic filling times (DiFTs) based on the detected beginnings of the diastolic periods and the detected ends of the diastolic periods.

27. The implantable system of claim 26, wherein:

the implantable sensor comprises a photoplethysmography sensor configured to produce a photoplethysmography (PPG) signal indicative of changes in arterial blood volume; and

the monitor is configured to detect a beginning of a DP based on a dicrotic notch of the PPG signal and an end of the DP based on a foot of the PPG signal following the dicrotic notch.