Method and apparatus for monitoring of diastolic hemodynamics

• US 8,636,669 B2
• Filed: 01/05/2011
• Issued: 01/28/2014
• Est. Priority Date: 12/30/2002
• Status: Active Grant

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Siejko, Krzysztof Z., Zhu, Qingsheng, Carlson, Gerrard M.
• Primary Examiner(s): STOKLOSA, JOSEPH A
• Application Number:
  US12/985,055
• Publication Number:
  US 20110098588A1
• Time in Patent Office: 1,119 Days
• Field of Search: 600/513, 600/528
• US Class Current: 600/528
• CPC Class Codes: A61B 5/02028 Determining haemodynamic parameters not otherwise provided for, e.g. cardiac contractility or left ventricular ejection fraction
• CPC Class Codes: A61B 7/00 Instruments for auscultation
• CPC Class Codes: A61N 1/36514 controlled by a physiological quantity other than heart potential, e.g. blood pressure controlled by two or more physical parameters A61N1/36585
• CPC Class Codes: A61N 1/36528 the parameter being measured by means of ultrasound

Abstract

A cardiac rhythm management system provides for ambulatory monitoring of hemodynamic performance based on quantitative measurements of heart sound related parameters for diagnostic and therapeutic purposes. Monitoring of such heart sound related parameters allows the cardiac rhythm management system to determine a need for delivering a therapy and/or therapy parameter adjustments based on conditions of a heart. This monitoring also allows a physician to observe or assess the hemodynamic performance for diagnosing and making therapeutic decisions. Because the conditions of the heart may fluctuate and may deteriorate significantly between physician visits, the ambulatory monitoring, performed on a continuous or periodic basis, ensures a prompt response by the cardiac rhythm management system that may save a life, prevent hospitalization, or prevent further deterioration of the heart.

Claims

1. A system adapted to be coupled to a patient, the system comprising:

an acoustic sensor including an accelerometer adapted to sense an acoustic energy and produce an acoustic sensor signal indicative of heart sounds of the patient;

a cardiac sensing circuit adapted to sense a cardiac signal indicative of cardiac electrical events;

a heart sound detector coupled to the acoustic sensor and the cardiac sensing circuit, the heart sound detector adapted to detect selected heart sounds indicative of ventricular diastolic hemodynamic performance using the acoustic sensor signal and the cardiac signal;

a parameter generator coupled to the heart sound detector, the parameter generator adapted to generate values of at least one predetermined parameter related to the selected heart sounds; and

a processor coupled to the parameter generator, the processor adapted to perform a statistical process analyzing the values of the at least one predetermined parameter generated for a predetermined duration and produce at least one trend quantitatively presenting one or more ventricular diastolic filling pattern changes during the predetermined duration using an outcome of the statistical process.

2. The system of claim 1, comprising a data acquisition enabler adapted to time data acquisition by enabling one or more system components according to a predetermined schedule, the one or more system components including one or more of the acoustic sensor, the cardiac sensing circuit, the heart sound detector, and the parameter generator.

3. The system of claim 1, comprising a therapy circuit communicatively coupled to the processor, the therapy circuit adapted to deliver at least one cardiac therapy with at least one therapy parameter determined based on the at least one trend.

4. The system of claim 1, wherein the heart sound detector comprises a gating module coupled to the acoustic sensor and the cardiac sensing circuit, the gating module adapted to generate heart sound detection windows each timed for detection of one of the selected heart sounds based on a time of occurrence of one of selected cardiac electrical events.

5. The system of claim 4, wherein the accelerometer is adapted to produce an acoustic sensor signal indicative of the heart sounds of the patient and physical activities of the patient, and the parameter generator comprises:

a noise monitoring module adapted to produce a background noise level using the acoustic sensor signal, the background noise level indicative of physical activities of the patient; and

a screening module coupled to the noise monitoring module and adapted to exclude the values of the at least one predetermined parameter generated using the measurements made when the background noise level exceeds a predetermined level.

6. The system of claims 5, wherein the processor is adapted to compare the at least one trend to a threshold level and produce an output representative of an outcome of a trending analysis.

7. The system of claim 6, wherein the processor is adapted to generate the threshold level using the values of the at least one predetermined parameter measured during a second predetermined period of time.

8. The system of claim 5, wherein the parameter generator comprises a strength detector adapted to measure amplitudes each associated with a selected type of the selected heart sounds.

9. The system of claim 5, wherein the parameter generator comprises a relative strength detector adapted to determine differences each between amplitudes associated with two selected types of the selected heart sounds.

10. The system of claim 5, wherein the parameter generator comprises an electromechanical interval timer adapted to measure time intervals each between a selected type of the selected heart sounds and a selected type of the selected cardiac electrical events.

11. The system of claim 5, wherein the parameter generator comprises a mechanical interval timer adapted to measure time intervals each between two selected types of the selected type heart sounds.

12. The system of claim 5, wherein the parameter generator comprises a frequency analyzer adapted to compute a fundamental frequency associated with a selected type of the selected heart sounds.

13. A method, comprising:

sensing an acoustic energy to produce an acoustic sensor signal using an accelerometer, the acoustic signal indicative heart sounds of a patient;

sensing at least one cardiac signal indicative of cardiac electrical events;

detecting selected heart sounds indicative of ventricular diastolic hemodynamic performance using the acoustic sensor signal and the cardiac signal;

generating values of at least one predetermined parameter related to the selected heart sounds using the acoustic sensor signal and the cardiac signal;

performing a statistical process analyzing selected values of the at least one predetermined parameter, the selected values associated with the selected heart sounds detected during a first predetermined period of time; and

producing at least one trend quantitatively presenting one or more ventricular diastolic filling pattern changes during the predetermined period of time using an outcome of the statistical process.

14. The method of claim 13, comprising delivering at least one therapy with at least one parameter determined based on the at least one trend.

15. The method of claim 13, comprising:

comparing a quantity associated with the at least one trend to a threshold level; and

generating the threshold level using values of the at least one predetermined parameter measured during a second predetermined period of time.

16. The method of claim 15, comprising generating an alert signal indicative of a change in one of diastolic filling patterns using an outcome of comparing the quantity associated with the at least one trend to the threshold level.

17. The method of claim 13, comprising:

producing a background noise level using the acoustic sensor signal, the background noise level indicative of the physical activities of the patient;

excluding the values of the at least one predetermined parameter generated using the acoustic sensor signal measured when the background noise level exceeds a predetermined level.

18. The method of claim 17, wherein detecting selected heart sounds comprises detecting at least third heart sound (S3) and forth heart sounds (S4).

19. The method of claim 18, wherein generating values of at least one predetermined parameter comprises generating values of strength of S3 relative to S4.

20. The method of claim 18, wherein generating values of at least one predetermined parameter comprises generating values of time interval between S3 and an adjacently subsequent atrial contraction.

21. The method of claim 18, wherein detecting selected heart sounds further comprises detecting second heart sounds (S2), and generating values of at least one predetermined parameter comprises generating values of time interval between onsets of S3 and S2.

22. The method of claim 18, wherein generating values of at least one predetermined parameter comprises generating values of fundamental frequency of S3.

23. The method of claim 18, wherein generating values of at least one predetermined parameter comprises generating values of fundamental frequency of S4.