Integrated cardiac rhythm management system with heart valve

• US 8,239,023 B2
• Filed: 12/23/2009
• Issued: 08/07/2012
• Est. Priority Date: 08/24/2006
• Status: Active Grant

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Shuros, Allan C., Kane, Michael J.
• Primary Examiner(s): GETZOW, SCOTT M
• Application Number:
  US12/645,934
• Publication Number:
  US 20100100144A1
• Time in Patent Office: 958 Days
• Field of Search: 607 4- 28, 600508-521, 623/2.1
• US Class Current: 607/18
• CPC Class Codes: A61F 2/2403 with pivoting rigid closure members check valves with hinged closure members in general F16K15/03
• CPC Class Codes: A61N 1/3621 for treating or preventing abnormally high heart rate
• 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 1/39622 Pacing therapy

Abstract

Systems and methods using a heart valve and an implantable medical device, such as for event detection and optimization of cardiac output. The cardiac management system includes a heart valve, having a physiological sensor. The physiological sensor is adapted to measure at least one of an intrinsic electrical cardiac parameter, a hemodynamic parameter or the like. The system further includes an implantable electronics unit, such as a cardiac rhythm management unit, coupled to the physiological sensor of the heart valve to receive physiological information. The electronics unit is adapted to use the received physiological information to control delivery of an electrical output to the subject.

Claims

1. A method comprising:

monitoring at least two physiological parameters using respective physiological sensors located at an implantable heart valve including;

monitoring at the heart valve an intrinsic electrical cardiac signal with an intrinsic electrical cardiac sensor located at the heart valve, and

monitoring a hemodynamic parameter at the heart valve with a hemodynamic sensor located at the heart valve; and

identifying a cardiac event using information about the physiological parameters from the physiological sensors at the heart valve, the identifying including;

detecting a cardiac event using information from at least one of the intrinsic electrical cardiac signal monitoring or hemodynamic parameter monitoring, and

classifying the cardiac event using information from one of the intrinsic electrical cardiac signal monitoring or hemodynamic parameter monitoring.

2. The method of claim 1, comprising communicating information about the physiological parameters from the physiological sensors at the heart valve to an implantable electronics unit, wherein the implantable electronics unit performs the identifying the cardiac event and controls delivery of electrical cardiac therapy in response to the classifying of the cardiac event.

3. The method of claim 1, wherein the cardiac event includes a bradyarrhythmia event and identifying the cardiac event includes:

detecting the cardiac event with the intrinsic electrical signal monitoring at the heart valve indicating one or more of a heart rate of less than a specified threshold value or a characteristic ECG depolarization waveform, and

classifying the cardiac event as the bradyarrhythmia event when the hemodynamic parameter monitoring at the heart valve indicates hemodynamic cardiac output below a specified hemodynamic cardiac output threshold.

4. The method of claim 3, wherein monitoring the hemodynamic parameter at the heart valve includes measuring one or more of a periodic rate of blood flow, periodic pressure variation within a chamber, or periodic pressure variation across the heart valve, and

the specified output threshold for classifying the cardiac event includes one or more of a periodic blood flow rate threshold, a periodic pressure variation threshold within a chamber, or a periodic pressure variation threshold across the heart valve.

5. The method of claim 1, wherein the cardiac event includes a fibrillation event, and identifying the cardiac event includes:

detecting the cardiac event with the hemodynamic parameter at the heart valve indicating hemodynamic cardiac output below a specified output threshold, and

classifying the cardiac event as the fibrillation event when the intrinsic electrical signal measurement at the heart valve indicates one or more of a specified ECG wave form periodicity or an ECG high frequency component exceeding a specified high frequency threshold.

6. The method of claim 5, wherein monitoring the hemodynamic parameter at the heart valve includes measuring one or more of valve motion or pressure fluctuation, and

the specified output threshold for detecting the cardiac event includes one or more of a valve motion threshold indicating incomplete or rapid valve position variation, or a pressure change threshold indicating small amplitude pressure fluctuations at the heart valve relative to a regular pressure fluctuation amplitude.

7. The method of claim 1, wherein the cardiac event includes an ischemia event, and identifying the cardiac event includes:

detecting the cardiac event with the hemodynamic parameter monitoring at the heart valve indicating hemodynamic cardiac output below a specified output threshold, and

classifying the cardiac event as the ischemia event where the intrinsic electrical signal measurement at the heart valve indicates one or more of a heart rate above a specified resting heart rate threshold and below a specified tachycardia heart rate threshold, or an elevated S-T segment above a specified S-T segment threshold.

8. The method of claim 1, comprising adjusting the hemodynamic parameter in response to the monitoring of the intrinsic electrical cardiac signal and monitoring of the hemodynamic parameter.

9. The method of claim 8, wherein adjusting the hemodynamic parameter includes:

associating a first sequential electrical cardiac delay with a first hemodynamic parameter measurement,

associating a second sequential electrical cardiac delay with a second hemodynamic parameter measurement, wherein the first and second sequential electrical cardiac delays are different and in sequence with each other, and the second hemodynamic parameter measurement is adjusted using the first hemodynamic parameter measurement,

associating a third sequential electrical cardiac delay with a third hemodynamic parameter measurement, the third hemodynamic parameter measurement is less optimal than the second hemodynamic parameter measurement, and the third sequential electrical cardiac delay is different from and in sequence to the first and second sequential electrical cardiac delays,

comparing the first, second and third hemodynamic parameter measurements, and determining whether the second hemodynamic parameter measurement is optimal, and

adjusting an electrical pulse therapy delay to correspond with the second sequential electrical cardiac delay to adjust the hemodynamic parameter.

10. The method of claim 1, comprising determining a rate responsive pacing upper rate limit.

11. The method of claim 10, wherein determining the rate responsive pacing upper limit includes:

associating a first sequential pacing rate with a first hemodynamic parameter measurement,

associating a second sequential pacing rate with a second hemodynamic parameter measurement, the first and second sequential pacing rates are different and in sequence with each other, and the second hemodynamic parameter measurement is optimal relative to the first hemodynamic parameter measurement,

associating a third sequential pacing rate with a third hemodynamic parameter measurement, the third hemodynamic parameter measurement is less optimal than the second hemodynamic parameter measurement, and the third sequential pacing rate is different from and in sequence to the first and second sequential pacing rates,

comparing the first, second and third hemodynamic parameter measurements, and determining whether the second hemodynamic parameter measurement is optimal, and

adjusting an electrical pacing rate to correspond with the second sequential pacing rate for use as the rate responsive pacing upper limit.

12. A method comprising:

monitoring at least two physiological parameters using respective physiological sensors located at an implantable heart valve including;

monitoring at the heart valve an intrinsic electrical cardiac signal with an intrinsic electrical cardiac sensor located at the heart valve, and

monitoring a hemodynamic parameter at the heart valve with a hemodynamic sensor located at the heart valve; and

identifying one or more cardiac events using information about the physiological parameters from the physiological sensors at the heart valve, the identifying including;

detecting a cardiac event using information from the hemodynamic parameter monitoring at the heart valve,

classifying the cardiac event as a first cardiac event using information from the intrinsic electrical cardiac signal monitoring at the heart valve that meets a first intrinsic electrical threshold, and

classifying the event as a second cardiac event using information from the intrinsic electrical cardiac monitoring at the heart valve that meets a second intrinsic electrical threshold different from the first intrinsic electrical threshold.

13. The method of claim 12, wherein identifying one or more cardiac events includes:

detecting the cardiac event including a low hemodynamic output event with the hemodynamic parameter monitoring at the heart valve,

classifying the low hemodynamic output event as the first cardiac event including bradyarrhythmia when the intrinsic electrical cardiac signal monitoring indicates a heart rate of less than a specified threshold value,

classifying the low hemodynamic output event as the second cardiac event including fibrillation if the intrinsic electrical cardiac signal monitoring indicates a specified ECG wave form periodicity or an ECG high frequency component exceeding a specified high frequency threshold.

14. The method of claim 12, wherein identifying one or more cardiac events includes:

detecting the cardiac event including a low hemodynamic output event with the hemodynamic parameter monitoring at the heart valve, and

classifying the low hemodynamic output event as the first cardiac event including ischemia if the intrinsic electrical cardiac signal monitoring indicates a heart rate above a resting heart rate threshold and below a tachyarrhythmia heart rate threshold.

15. The method of claim 14, wherein ischemia includes myocardial infarction.

16. The method of claim 14, wherein classifying the low hemodynamic output event as the second cardiac event includes classifying the second cardiac event as one of bradyarrhythmia or tachyarrhythmia including:

classifying the second cardiac event as bradyarrhythmia where the intrinsic electrical signal monitoring indicates the heart rate is below the resting heart rate threshold, and

classifying the second cardiac event as tachyarrhythmia where the intrinsic electrical signal monitoring indicates the heart rate is at or above a tachyarrhythmia heart rate threshold.

17. The method of claim 12, wherein identifying one or more cardiac events includes:

detecting the cardiac event including a low hemodynamic output event with the hemodynamic parameter monitoring at the heart valve, and

classifying the low hemodynamic output event as the first cardiac event including ischemia when the intrinsic electrical cardiac monitoring indicates an elevated S-T segment relative to an S-T segment threshold.

18. The method of claim 12, wherein identifying one or more cardiac events using information about the physiological parameters from the physiological sensors at the heart valve includes:

detecting the cardiac event including a low hemodynamic output event with the hemodynamic parameter monitoring at the heart valve, and

classifying the cardiac event as a first cardiac event including bradyarrhythmia when the intrinsic electrical cardiac monitoring indicates a distinct bradyarrhythmia periodic ECG signal.

19. The method of claim 12, wherein identifying one or more cardiac events with information about the physiological parameters from the physiological sensors at the heart valve includes:

detecting the cardiac event including a low hemodynamic output event using the hemodynamic parameter monitoring at the heart valve, and

classifying the cardiac event as a first cardiac event including fibrillation when the intrinsic electrical cardiac monitoring indicates a specified ECG wave form periodicity threshold of an ECG wave form or an ECG high frequency component exceeding a specified high frequency threshold.

20. The method of claim 12, wherein monitoring the hemodynamic parameter at the heart valve includes one or more of monitoring a periodic rate of blood flow with a flow sensor, monitoring a valve cycling rate or monitoring pressures within one or more heart chambers.