Managing preload reserve by tracking the ventricular operating point with heart sounds

• US 8,579,828 B2
• Filed: 04/16/2012
• Issued: 11/12/2013
• Est. Priority Date: 07/26/2005
• Status: Active Grant

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Carlson, Gerrard M., Wariar, Ramesh, Siejko, Krzysztof Z.
• Primary Examiner(s): Heller, Tammie K
• Application Number:
  US13/447,506
• Publication Number:
  US 20120203116A1
• Time in Patent Office: 575 Days
• Field of Search: 600/483, 600/514, 600/528
• US Class Current: 600/528
• CPC Class Codes: A61B 5/021 Measuring pressure in heart or blood vessels A61B5/0205 takes precedence
• CPC Class Codes: A61B 5/349 Detecting specific parameters of the electrocardiograph cycle
• CPC Class Codes: A61B 7/00 Instruments for auscultation
• CPC Class Codes: A61B 7/04 Electric stethoscopes microphones, acoustic transducers therefor H04R
• CPC Class Codes: A61M 5/1723 using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00
• CPC Class Codes: A61N 1/36585 controlled by two or more physical parameters
• CPC Class Codes: A61N 1/37 Monitoring; Protecting

Abstract

A system and method for managing preload reserve and tracking the inotropic state of a patient'"'"'s heart. The S1 heart sound is measured as a proxy for direct measurement of stroke volume. The S3 heart sound may be measured as a proxy for direct measurement of preload level. The S1-S3 pair yield a point on a Frank Starling type of curve, and reveal information regarding the patient'"'"'s ventricular operating point and inotropic state. As an alternative, or in addition to, measurement of the S3 heart sound, the S4 heart sound may be measured or a direct pressure measurement may be made for the sake of determining the patient'"'"'s preload level. The aforementioned measurements may be made by a cardiac rhythm management device, such as a pacemaker or implantable defibrillator.

Claims

1. A medical device comprising:

a transducer; and

a control circuit coupled to the transducer, the control circuit configured to;

monitor an S1 heart sound amplitude emitted by a heart of a patient;

monitor a proxy variable indicating preload exhibited by the heart, the proxy variable including at least one of a blood pressure magnitude or a heart sound amplitude other than an S1 heart sound amplitude;

measure a first inotropic state defined by a state variable pair obtained during a first time period, the state variable pair comprising;

an S1 heart sound amplitude value; and

a proxy variable value;

measure a second inotropic state defined by a state variable pair obtained during a second time period, the state variable pair comprising;

an S1 heart sound amplitude value; and

a proxy variable value; and

determine whether the heart has exhibited an inotropic state change by comparing the state variable pair of the second inotropic state to the state variable pair of the first inotropic state.

2. The medical device of claim 1, wherein the medical device includes an ambulatory device.

3. The medical device of claim 1, wherein the control circuit is configured to communicate a control signal to a device using information about the determined inotropic state change.

4. The medical device of claim 1, wherein the control circuit monitors a proxy variable indicating preload by monitoring an S3 heart sound or an S4 heart sound.

5. The medical device of claim 1, wherein the control circuit monitors a proxy variable indicating preload by:

sensing a plurality of S3 heart sounds or S4 heart sounds emitted by a heart of a patient, each of which is represented as a time-varying signal with at least one maxima and minima; and

finding a greatest difference between a minima and maxima that are consecutive for each of the time-varying signals representing the plurality of S3 heart sounds or S4 heart sounds, yielding a set of peak-to-peak differences, wherein the control circuit monitors an inotropic state of the heart, using the set of peak-to-peak differences and an indicator of stroke volume.

6. The medical device of claim 1, comprising a pressure sensor in data communication with the control circuit, wherein the control circuit monitors a proxy variable indicating preload by monitoring blood pressure.

7. The medical device of claim 1, wherein the control circuit is configured to determine that the heart has exhibited an inotropic state change by identifying an occurrence in which the S1 heart sound indicates a change in stroke volume and the proxy variable indicates a change in preload.

8. The medical device of claim 1, comprising stimulation and sensing circuitry interposed between the control circuit and an electrode system configured to make electrical contact with the heart, wherein the control circuit is configured to apply cardiac resynchronization therapy to the heart, based upon a set of parameters.

9. The medical device of claim 8, wherein the control circuit is configured to adjust one or more of the set of parameters based upon the inotropic state or preload level exhibited by the heart.

10. The medical device of claim 1, comprising an activity sensor coupled to the control circuit, the activity sensor generating a signal exhibiting a time-varying characteristic indicating an activity level of the patient, wherein the control circuit is configured to determine ventricular function, based upon the S1 heart sound amplitude, the proxy variable, and the signal generated by the activity sensor.

11. A medical device comprising:

a transducer; and

a control circuit coupled to the transducer, the control circuit configured to;

monitor an S1 heart sound amplitude emitted by a heart of a patient;

monitor a proxy variable indicating preload exhibited by the heart including monitoring an S3 heart sound, an S4 heart sound, or a blood pressure;

measure a first inotropic state defined by a state variable pair obtained during a first time period, the state variable pair comprising;

an S1 heart sound amplitude value; and

a proxy variable value;

measure a second inotropic state defined by a state variable pair obtained during a second time period, the state variable pair comprising;

an S1 heart sound amplitude value; and

a proxy variable value; and

determine whether the heart has exhibited an inotropic state change by comparing the state variable pair of the second inotropic state to the state variable pair of the first inotropic state.

12. The medical device of claim 11, wherein the medical device includes an ambulatory device.

13. The medical device of claim 11, wherein the control circuit is configured to communicate a control signal to a preload altering device using information about the determined inotropic state change.

14. The medical device of claim 11, wherein the control circuit is configured to communicate a control signal to an inotropic state altering device using information about the determined inotropic state change.

15. The medical device of claim 11, comprising a pressure sensor in data communication with the control circuit, wherein the control circuit monitors a proxy variable indicating preload by monitoring blood pressure.

16. A medical device comprising:

a transducer; and

a control circuit coupled to the transducer, the control circuit configured to;

monitor an S1 heart sound amplitude emitted by a heart of a patient;

monitor a proxy variable indicating preload exhibited by the heart including monitoring a plurality of S3 heart sounds or S4 heart sounds emitted by the heart of the patient;

measure a first inotropic state defined by a state variable pair obtained during a first time period, the state variable pair comprising;

an S1 heart sound amplitude value; and

a proxy variable value;

measure a second inotropic state defined by a state variable pair obtained during a second time period, the state variable pair comprising;

an S1 heart sound amplitude value; and

a proxy variable value; and

determine whether the heart has exhibited an inotropic state change by comparing the state variable pair of the second inotropic state to the state variable pair of the first inotropic state.

17. The medical device of claim 16, wherein the control circuit is configured to monitor the proxy variable by sensing a plurality of S3 heart sounds or S4 heart sounds emitted by a heart of a patient, each of which is represented as a time-varying signal with at least one maxima and minima;

and finding a greatest difference between a minima and maxima that are consecutive for each of the time-varying signals representing the plurality of S3 heart sounds or S4 heart sounds, yielding a set of peak-to-peak differences, wherein the control circuit monitors an inotropic state of the heart, using the set of peak-to-peak differences and an indicator of stroke volume.

18. The medical device of claim 16, wherein the control circuit is configured to communicate a control signal to a device using information about the determined inotropic state change.

19. The medical device of claim 16, comprising stimulation and sensing circuitry interposed between the control circuit and an electrode system configured to make electrical contact with the heart, wherein the control circuit is configured to apply cardiac resynchronization therapy to the heart, based upon a set of parameters.

20. The medical device of claim 19, wherein the control circuit is configured to adjust one or more of the set of parameters based upon the inotropic state or preload level exhibited by the heart.