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

• US 9,403,017 B2
• Filed: 11/11/2013
• Issued: 08/02/2016
• 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:
  US14/076,771
• Publication Number:
  US 20140073971A1
• Time in Patent Office: 995 Days
• US Class Current: 1/1
• 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 system comprising:

a preload altering device;

an implantable device including

a transducer;

a control circuit coupled to the transducer, the control circuit configured to cooperate with the transducer to monitor an S1 heart sound emitted by a heart of a patient, monitor a proxy variable indicating preload exhibited by the heart, and communicate a control signal to the preload altering device to deliver a level of a diuretic

wherein the control circuit is configured to measure a first state of the patient based on a first monitored S1 heart sound and a first monitored proxy variable and to measure a second state of a patient based on a second monitored S1 heart sound and a second monitored proxy variable; and

wherein the control circuit is configured to determine that the heart has reached a critical preload by a comparison of the first state to the second state; and

wherein the control circuit is configured to determine that the heart has reached a critical preload by a determination of a slope between the first state and the second state and comparing the slope to a threshold value, the threshold value being a value that approximately corresponds with the critical preload level on a Frank Starling curve.

2. The system of claim 1, wherein the preload altering device includes a substance dispenser.

3. The system of claim 1, wherein the control circuit monitors a proxy variable indicating preload by monitoring an S3 heart sound.

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

5. The system of claim 1, wherein the implantable device further includes a pressure sensor in data communication with the control circuit, and wherein the control circuit monitors a proxy variable indicating preload by monitoring blood pressure.

6. The system of claim 5, wherein the pressure sensor is located in a right ventricle.

7. The system of claim 1, wherein the implantable device further includes a pressure sensor in data communication with the control circuit, and wherein the control circuit monitors a proxy variable indicating preload by monitoring blood pressure in the pulmonary artery.

8. The system of claim 1, wherein the control circuit is configured such that if the slope is less than the threshold, the control signal to the preload altering device provides further preload therapy.

9. The system of claim 1, wherein the control circuit is configured such that if the slope is greater than the threshold, the control signal to the preload altering device terminates preload therapy.

10. A method comprising:

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

monitoring a proxy variable indicating preload exhibited by the heart, the proxy variable including at least one of a heart sound amplitude or a blood pressure magnitude;

measuring a first preload state defined by a state variable pair obtained during a first time period, the state variable pair comprising;

(1) an S1 heart sound amplitude value; and

(2) a proxy variable value;

measuring a second preload state defined by a state variable pair obtained during a second time period, the state variable pair comprising;

(1) an S1 heart sound amplitude value; and

(2) a proxy variable value; and

determining whether the heart has exhibited a preload state exceeding the critical preload by comparing the state variable pair of the second preload state to the state variable pair of the first preload state;

communicating the preload state to a preload altering device if the determined preload state exceeds the critical preload.

11. The method of claim 10, wherein monitoring a proxy variable comprises monitoring an S3 heart sound.

12. The method of claim 10, wherein monitoring a proxy variable comprises monitoring an S4 heart sound.

13. The method of claim 10, wherein monitoring a proxy variable comprises measuring blood pressure in the right ventricle.

14. The method of claim 10, wherein monitoring a proxy variable comprises measuring blood pressure in the pulmonary artery.

15. The method of claim 10, further comprising delivering preload altering therapy if the determined preload state exceeds the critical preload.

16. The method of claim 10, wherein comparing the state variable pair of the second preload state to the state variable pair of the first preload state includes determining a slope of the state variable pair of the second preload state to the state variable pair of the first preload state and comparing the slope to a threshold value, the threshold value being a value that approximately corresponds with the critical preload level on a Frank Starling curve.

17. The method of claim 16, further comprising delivering preload therapy if the slope is less than the threshold and terminating therapy if the slope is greater than the threshold.