Integrated cardiac rhythm management system with heart valve

• US 7,643,879 B2
• Filed: 08/24/2006
• Issued: 01/05/2010
• 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: Kane, Michael J., Shuros, Allan C.
• Primary Examiner(s): Getzow; Scott M
• Application Number:
  US11/466,974
• Publication Number:
  US 20080051838A1
• Time in Patent Office: 1,230 Days
• Field of Search: 623 21- 242, 607 4- 28
• 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. An apparatus comprising:

a heart valve, including a physiological sensor, the heart valve adapted for implantation into a subject, the physiological sensor including;

an intrinsic electrical cardiac signal sensor configured to sense an electrical cardiac signal at the heart valve; and

a hemodynamic parameter sensor configured to sense at the heart valve a hemodynamic parameter indicative of a blood hemodynamic characteristic sensed at the heart valve; and

an implantable electronics unit wirelessly coupled via a non-RF intrabody communication link to the physiological sensor of the heart valve to receive physiological information about the intrinsic electrical cardiac signal sensed at the heart valve and the hemodynamic parameter sensed at the heart valve, the electronics unit adapted to use the received physiological information to control delivery of an electrical output to the subject.

2. The apparatus of claim 1, wherein

the implantable electronics unit is configured to use the hemodynamic parameter and the electrical cardiac signal to detect a tachyarrhythmia and to declare the tachyarrhythmia as a first tachyarrhythmia type when a hemodynamic parameter value is below a specified threshold or to declare the tachyarrhythmia as a second tachyarrhythmia type when the hemodynamic parameter value is above a specified threshold.

3. The apparatus of claim 1, wherein the physiological sensor includes a hemodynamic parameter sensor.

4. The apparatus of claim 3, wherein the hemodynamic parameter sensor includes a blood flow sensor.

5. The apparatus of claim 4, wherein the heart valve includes:

a strut, extending across a valve opening of the heart valve;

a leaflet, movably coupled with the strut; and

wherein the blood flow sensor is coupled along the strut.

6. The apparatus of claim 5, wherein the orientation of the blood flow sensor is parallel with a general direction of blood flow through the valve.

7. The apparatus of claim 3, wherein the hemodynamic parameter sensor includes a pressure sensor.

8. The apparatus of claim 7, wherein the heart valve includes a valve ring having a first face and a second face, and a first pressure transducer is coupled to the first face to collect pressure measurements in a first heart chamber, and a second pressure transducer is coupled along the second face to collect pressure measurements in a second heart chamber.

9. The apparatus of claim 3, wherein the hemodynamic parameter sensor includes a valve deflection sensor.

10. The apparatus of claim 9, wherein the valve deflection sensor includes at least one of a sensor selected from the group consisting of electromagnetic coils, a piezo-resistive element, piezo-electric element, a Hall Effect sensor, an acoustic sensor, and an optical sensor.

11. The apparatus of claim 1, wherein the heart valve includes at least one defibrillation electrode.

12. The apparatus of claim 1, wherein the heart valve includes at least one pacing electrode.

13. The apparatus of claim 1, wherein the implantable electronics unit is a chronically implanted electronics unit.

14. The apparatus of claim 1, wherein a non-RF wirelessly coupling between the physiological sensor of the heart valve and the implantable electronics unit consists of at least one of:

an ultrasound coupling, an electric field coupling, an optical coupling, an inductive coupling, and a conductor as the body coupling.

15. A method comprising:

measuring at least two physiological parameters using a plurality of physiological sensors located at an implantable heart valve including;

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

measuring a hemodynamic parameter at the heart valve with a hemodynamic sensor located at the heart valve;

communicating information about the physiological parameters from the physiological sensors at the heart valve for use as control inputs to an implantable electronics unit to control delivery of electrical therapy;

controlling delivery of electrical therapy including;

detecting a tachyarrhythmia with the measurement of the intrinsic electrical cardiac signal at the heart valve,

classifying the tachyarrhythmia as a first tachyarrhythmia type if the measured hemodynamic parameter at the heart valve indicates inadequate cardiac output, and

classifying the tachyarrhythmia as a second tachyarrhythmia type if the measured hemodynamic parameter at the heart valve indicates adequate cardiac output; and

delivering at least one electrical therapy to a subject including;

triggering delivery of a first anti-tachyarrhythmia therapy in response to a detected tachyarrhythmia of the first tachyarrhythmia type; and

triggering delivery of a different second anti-tachyarrhythmia therapy in response to a detected tachyarrhythmia of the second tachyarrhythmia type.

16. The method of claim 15, wherein measuring the hemodynamic parameter includes measuring a blood flow.

17. The method of claim 15, wherein measuring the hemodynamic parameter includes measuring a blood pressure.

18. The method of claim 15, wherein measuring the hemodynamic parameter includes measuring a heart valve deflection.

19. The method of claim 15, wherein measuring the hemodynamic parameter includes measuring a valve leaflet angle.

20. The method of claim 15, wherein the communicating comprises wireless intrabody communicating to the implantable electronics unit from the physiological sensors of the heart valve using a non-RF transmission or reception.

21. The method of claim 20, wherein the wireless intrabody communicating to the implantable electronics unit that is separately located from the implantable heart valve without RF transmission or reception consists of at least one of:

ultrasound communication, wireless electric field communication, optical communication, inductive communication, and communication with the body as a conductor.

22. The method of claim 15, further comprising:

obtaining energy by movement of a portion of the valve;

storing the generated energy; and

using the energy for the measuring or the communicating.

23. The method of claim 22, wherein obtaining energy includes deflecting a piezo-electric element coupled between a valve ring and a valve leaflet.

24. The method of claim 22, wherein obtaining energy includes moving a magnetic portion of the valve with respect to a coil in a valve ring.

25. The method of claim 15, further comprising adjusting a delay between electrical pulses delivered to the same or different heart chambers using the information about the physiological parameter as a control input.

26. The method of claim 25, wherein measuring the physiological parameter includes measuring a duration for which the heart valve is open, and wherein the adjusting the delay is performed so as to generally optimize the measured duration for which the heart valve is open.

27. The method of claim 25, wherein adjusting the delay is performed so as to generally minimize a delay between:

(1) an electrical pulse delivered to one of the right and left ventricles; and

(2) an opening of the heart valve.

28. The method of claim 25, wherein adjusting the delay includes adjusting the delay between electrical pulses delivered to an atrium and ventricle during the same cardiac cycle.

29. The method of claim 15, wherein the measuring includes measuring a delay between an opening of a first valve and an opening of a second valve.

30. The method of claim 15, further comprising changing a pacing site using the information about the physiological parameter.

31. The method of claim 15, wherein the measuring the physiological parameter includes determining an indication of cardiac output, and further comprising using the indication of cardiac output to establish a rate-responsive pacing upper rate limit.

32. The method of claim 15 further comprising communicating information about the physiological parameter from the sensor for to at least one of an implantable electronics unit and an external system.

33. The method of claim 15 wherein measuring a physiological parameter using a physiological sensor includes measuring regurgitation of blood through the heart valve.

34. The method of claim 15, wherein triggering delivery of the first anti-tachyarrhythmia therapy includes defibrillation therapy, and triggering delivery of a different second anti-tachyarrhythmia therapy includes anti-tachyarrhythmia pacing.