Trending S1 heart sounds amplitudes in ambulatory patients for worsening HF detection

• US 10,166,001 B2
• Filed: 10/26/2016
• Issued: 01/01/2019
• Est. Priority Date: 10/27/2015
• Status: Active Grant

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: An, Qi, Thakur, Pramodsingh Hirasingh
• Primary Examiner(s): Lee, Erica
• Application Number:
  US15/334,388
• Publication Number:
  US 20170112463A1
• Time in Patent Office: 797 Days
• Field of Search: None
• CPC Class Codes: A61B 5/0205 Simultaneously evaluating both cardiovascular conditions and different types of body conditions, e.g. heart and respiratory condition
• CPC Class Codes: A61B 5/0245 by using sensing means generating electric signals, i.e. ECG signals
• CPC Class Codes: A61B 5/053 Measuring electrical impedance or conductance of a portion of the body
• CPC Class Codes: A61B 5/0816 Measuring devices for examining respiratory frequency measuring frequency of electric signals G01R23/00
• CPC Class Codes: A61B 5/091 Measuring volume of inspired or expired gases, e.g. to determine lung capacity
• CPC Class Codes: A61B 5/318 Heart-related electrical modalities, e.g. electrocardiography [ECG]
• CPC Class Codes: A61B 5/352 Detecting R peaks, e.g. for synchronising diagnostic apparatus; Estimating R-R interval
• 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 5/746 Alarms related to a physiological condition, e.g. details of setting alarm thresholds or avoiding false alarms alarms per se G08B
• CPC Class Codes: A61B 7/02 Stethoscopes acoustic details thereof G10K11/00
• CPC Class Codes: A61B 7/04 Electric stethoscopes microphones, acoustic transducers therefor H04R
• CPC Class Codes: A61N 1/00 Electrotherapy; Circuits therefor A61N2/00 takes precedence; irradiation apparatus A61N5/00
• CPC Class Codes: A61N 1/36507 controlled by gradient or slope of the heart potential
• CPC Class Codes: A61N 1/36578 controlled by mechanical motion of the heart wall, e.g. measured by an accelerometer or microphone
• CPC Class Codes: A61N 1/36585 controlled by two or more physical parameters
• CPC Class Codes: G16H 50/30 for calculating health indices; for individual health risk assessment

Abstract

An apparatus comprises a cardiac signal sensing circuit, a heart sound sensing circuit, and a signal processing circuit. The cardiac signal sensing circuit is configured to sense a plurality of cardiac signals representative of electrical cardiac activity of a subject. The heart sound sensing circuit is configured to sense a plurality of unfiltered heart sound signals representative of intrinsic mechanical cardiac activity of the subject. The signal processing circuit is configured to: detect an R-wave in a sensed cardiac signal and initiate a measurement window in a time relationship to the detected R-wave; determine amplitude of an S1 heart sound using a heart sound signal sensed during the measurement window; trend S1 heart sound amplitudes determined for the plurality of the unfiltered heart sound signals; and generate an alert when the trended S1 heart sound amplitude decreases below a threshold amplitude value.

Claims

1. An apparatus comprising:

a cardiac signal sensing circuit configured to sense a plurality of cardiac signals representative of electrical cardiac activity of a subject;

a heart sound sensing circuit configured to sense a plurality of heart sound signals representative of intrinsic mechanical cardiac activity of the subject; and

a signal processing circuit configured to;

detect a signal fiducial in a sensed cardiac signal and initiate a measurement window in a time relationship to the detected fiducial;

determine amplitudes of S1 heart sounds during the measurement window using the plurality of sensed heart sound signals;

calculate a short-term central tendency of the S1 heart sound amplitudes over a time duration of N days, where N is a positive integer less than or equal to five;

calculate a long-term central tendency of the S1 heart sound amplitudes for a time duration longer than N days, during different days than the short-term central tendency, and at least partially prior to the short-term central tendency;

trend a long-term to short-term difference between the calculated long-term central tendency of the S1 heart sound amplitudes and the calculated short-term central tendency of the S1 heart sound amplitudes; and

generate an alert using the calculated short-term central tendency and the calculated long-term central tendency.

2. The apparatus of claim 1, wherein the signal processing circuit is configured to:

trend a value of a ratio that includes the long-term to short-term difference and the calculated long-term central tendency of the S1 heart sound; and

generate the alert when the ratio satisfies a threshold ratio value.

3. The apparatus of claim 1, wherein the signal processing circuit is configured to:

smooth values of the long-term to short-term difference using a smoothing function; and

generate the alert when the short-term central tendency of the S1 heart sound is decreasing and the smoothed value of the long-term to short-term difference exceeds the threshold difference value.

4. The apparatus of claim 3, wherein the signal processing circuit is configured to smooth values of the long-term to short-term difference using an exponential smoothing function.

5. The apparatus of claim 1, wherein the signal processing circuit is configured to:

calculate a root mean square (RMS) value of the S1 heart sound amplitude during the measurement window;

and use RMS values of the S1 heart sound amplitude to calculate the short-term central tendency and the long-term central tendency of the S1 heart sound amplitudes.

6. The apparatus of claim 1, wherein the signal processing circuit is configured to detect an R-wave in the sensed cardiac signal and initiate a measurement window in a time relationship to the R-wave.

7. The apparatus of claim 1, wherein the signal processing circuit is configured to:

calculate at least one of peak amplitude values during the measurement window, peak-to-peak (PP) amplitude values during the measurement window, and energy measurement values representative of intrinsic mechanical cardiac activity during at least a portion of the measurement window;

calculate the short-term central tendency and the long-term central tendency of the S1 heart sound amplitudes using the at least one of the peak amplitude values, PP amplitude values, and energy measurement values.

8. The apparatus of claim 1, wherein the signal processing circuit is configured to:

trend a long-term to short-term difference between the calculated long-term central tendency of the S1 heart sound amplitudes and the calculated short-term central tendency of the S1 heart sound amplitudes, and

generate the alert when a trend of the calculated short-term central tendency of the S1 heart sound amplitudes is decreasing and a trend of the long-term to short-term difference exceeds a threshold difference value.

9. The apparatus of claim 1, wherein the signal processing circuit is configured to:

determine amplitudes of S3 heart sounds using the heart sound signals; and

generate the alert when a trend of the long-term to short-term difference exceeds a threshold difference value and the amplitude of the S3 heart sound exceeds an S3 amplitude threshold value.

10. The apparatus of claim 1, including a thoracic impedance sensing circuit configured to generate a thoracic impedance signal representative of thoracic impedance of the subject, wherein the signal processing circuit is configured to determine at least one of:

a value of intra-thoracic total impedance (ITTI) of the subject using the thoracic impedance signal, and generate the alert when a trend of the long-term to short-term difference exceeds a threshold difference value and the value of ITTI decreases below a threshold ITTI value;

a value of respiration rate using the thoracic impedance signal, and generate the alert when a trend of the long-term to short-term difference exceeds a threshold difference value and the value of respiration rate increases above a threshold respiration rate value;

a value of tidal volume (TV) of the subject using the thoracic impedance signal, and generate the alert when a trend of the long-term to short-term difference exceeds a threshold difference value and the TV decreases below a specified threshold TV value;

or

a value of respiration rate of the subject and a value of TV of the subject using the thoracic impedance signal, and generate the alert when a trend of the long-term to short-term difference exceeds a threshold difference value and a ratio including respiration rate and TV satisfies a threshold ratio value.

11. The apparatus of claim 1, wherein the signal processing circuit is configured to determine heart rate of the subject using the plurality of cardiac signals, and generate the alert when a trend of the long-term to short-term difference exceeds a threshold difference value and the determined heart rate of the subject increases above a threshold heart rate value.

12. A method of controlling operation of a medical device system, the method comprising:

sensing a plurality of cardiac signals representative of electrical cardiac activity of a subject;

sensing a plurality of heart sound signals representative of intrinsic mechanical cardiac activity of the subject;

determining amplitude of an S1 heart sound using a heart sound signal during a measurement window initiated in a specified time relationship to a signal fiducial detected in a cardiac signal;

calculating a short-term central tendency of the S1 heart sound amplitudes over a time duration of N days, where N is a positive integer less than or equal to five;

calculating a long-term central tendency of the S1 heart sound amplitudes for a time duration longer than N days, during different days than the short-term central tendency, and at least partially prior to the short-term central tendency;

trending a long-term to short-term difference between the calculated long-term central tendency of the S1 heart sound amplitudes and the calculated short-term central tendency of the S1 heart sound amplitudes; and

generating an alert using the calculated short-term central tendency and long-term central tendency.

13. The method of claim 12, wherein the trending a long-term to short-term difference includes smoothing values of the long-term to short-term difference using an exponential smoothing function, and wherein the generating an alert includes generating the alert when the short-term central tendency of the S1 heart sound is decreasing and the smoothed value of the long-term to short-term difference exceeds the threshold difference value.

14. The method of claim 12, wherein the trending amplitudes of S1 heart sounds includes:

trending a long-term to short-term difference between the calculated long-term central tendency of the S1 heart sound amplitudes and the calculated short-term central tendency of the S1 heart sound amplitudes; and

generating the alert when a trend of the calculated short-term central tendency of the S1 heart sound amplitudes is decreasing and a trend of the long-term to short-term difference exceeds a threshold difference value.

15. A system comprising a first medical device and a second medical device, wherein the first medical device includes:

a cardiac signal sensing circuit configured to sense a cardiac signal representative of electrical cardiac activity of a subject;

an R-wave detection circuit configured to detect an R-wave in a sensed cardiac signal;

a heart sound sensing circuit configured to sense an heart sound signal representative of intrinsic mechanical cardiac activity of the subject;

a sampling circuit configured to produce sampled values of the heart sound signal during a measurement window initiated in a time relation to the R-wave detected in the cardiac signal;

a first communication circuit configured to communicate the sampled values to the second medical device, wherein the second medical device includes;

a second communication circuit configured to communicate information with the first medical device including to receive the sampled values; and

a signal processing circuit configured to;

calculate a root mean square (RMS) value of amplitude of an S1 heart sound during the measurement window;

calculate a short-term central tendency of the RMS values of S1 heart sound amplitude for a time duration of N days, where N is a positive integer less than or equal to five;

calculate a long-term central tendency of the RMS values of S1 heart sound amplitude for a time duration longer than N days, wherein the long-term central tendency is calculated during different days than the short-term central tendency and at least partially prior to the short-term central tendency;

trend a long-term to short-term difference between the calculated long-term central tendency and the calculated short-term central tendency; and

generate an alert using the calculated short-term central tendency and long-term central tendency.

16. The system of claim 15, wherein the first medical device is a wearable or handheld medical device and the second medical device includes a server.

17. The system of claim 15, wherein the first medical device is an implantable medical device and the second medical device is a programmer for the implantable medical device.