Implantable medical device system with sensor for hemodynamic stability and method of use

• US 6,615,083 B2
• Filed: 04/27/2001
• Issued: 09/02/2003
• Est. Priority Date: 04/27/2001
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Küpper, Bernhard
• Primary Examiner(s): Schaetzle, Kennedy
• Assistant Examiner(s): DROESCH, KRISTEN L
• Application Number:
  US09/842,877
• Publication Number:
  US 20030014083A1
• Time in Patent Office: 858 Days
• Field of Search: 600/508-509, 600/515-516, 607/1-5, 607/9, 607/17, 607/25
• US Class Current: 607/25
• CPC Class Codes: A61N 1/3622 comprising two or more electrodes co-operating with different heart regions
• CPC Class Codes: A61N 1/365 controlled by a physiological parameter, e.g. heart potential evoked response A61N1/371

Abstract

An implantable medical device system for regulating a heart of a patient. The system includes a first sensor, a second sensor, a processor, and a medical device. The first sensor is capable of sensing activity of a heart atrium. The second sensor is capable of sensing activity of a heart ventricle. The processor is coupled to the first and second sensors and is capable of determining an atrial cycle time and a ventricular cycle time based upon signals from the first and second sensors. The processor is further capable of generating a hemodynamic baseline ratio based upon an atrial cycle time and a ventricular cycle time of a hemodynamic heartbeat, as well as an active ratio based upon an atrial cycle time and a ventricular cycle time of an active heartbeat. The processor is further capable of comparing the hemodynamic baseline ratio and the active ratio, and determining a corrective action based upon this comparison. The medical device is capable of supplying a therapy to the heart and is coupled to the processor. With this configuration, the processor is configured to control desired operation of the medical device based upon the determined corrective action.

Claims

1. A system for evaluating functioning of a heart of a patient in conjunction with an implantable medical device, the system comprising:

a first sensor capable of sensing activity of a heart atrium;

a second sensor capable of sensing activity of a heart ventricle; and

a processor coupled to the first and second sensors, the processor configured for;

determining an atrial cycle time and a ventricular cycle time for a heartbeat based upon signals from the first and second sensors,

generating an active ratio based upon atrial cycle time and ventricular cycle time of an active heartbeat,

comparing the active ratio to a hemodynamic baseline ratio,

evaluating functioning of the heart based upon the comparison.

2. The system of claim 1, wherein the processor is further capable of establishing the hemodynamic baseline ratio based upon an atrial cycle time and a ventricular cycle time of a hemodynamic heartbeat.

3. The system of claim 2, wherein the processor is capable of analyzing a plurality of preliminary ratios, each based upon an atrial cycle time and a ventricular cycle time of a respective preliminary heartbeat, to establish the hemodynamic baseline ratio.

4. The system of claim 1, wherein the active ratio is atrial cycle time/ventricular cycle time for the active heartbeat.

5. The system of claim 1, wherein the processor is capable of determining an atrial depolarization period and an atrial repolarization period for the active heartbeat.

6. The system of claim 1, wherein the processor is capable of determining a ventricular depolarization period and a ventricular repolarization period for the active heartbeat.

7. The system of claim 1, wherein the processor is capable of determining a corrective therapy for the patient based upon the comparison of the active ratio and the hemodynamic baseline ratio.

8. The system of claim 1, wherein the processor is capable of generating a trend based upon a plurality of active ratios in comparison to the hemodynamic baseline ratio, and evaluating functioning of the heart based upon the trend.

9. An implantable medical device system for regulating a heart of a patient, the system comprising:

a first sensor capable of sensing activity of a heart atrium;

a second sensor capable of sensing activity of a heart ventricle;

a processor coupled to the first and second sensors, the processor configured for;

determining an atrial cycle time and a ventricular cycle time based upon signals from the first and second sensors,

generating a hemodynamic baseline ratio based upon an atrial cycle time and a ventricular cycle time of a hemodynamic heartbeat,

generating an active ratio based upon an atrial cycle time and a ventricular cycle time of an active heart beat,

comparing the hemodynamic baseline ratio and the active ratio,

determining a corrective action based upon the comparison of the hemodynamic baseline ratio and the active ratio; and

a medical device capable of delivering a therapy to the patient and coupled to the processor;

wherein the processor is configured to prompt desired activation of the medical device based upon the determined corrective action.

10. The system of claim 9, wherein the medical device is a pacemaker.

11. The system of claim 10, wherein the pacemaker is a dual chamber pacemaker.

12. The system of claim 11, wherein the dual chamber pacemaker contains the processor.

13. The system of claim 9, wherein the medical device is a defibrillator.

14. The system of claim 9, wherein the medical device is a drug delivery system.

15. The system of claim 9, wherein the first sensor is a PT sensor.

16. The system of claim 9, wherein the second sensor is a QT sensor.

17. The system of claim 9, wherein the processor is a microprocessor.

18. The system of claim 9, wherein the hemodynamic baseline ratio is a ratio of atrial cycle time/ventricular cycle time of a hemodynamic heartbeat.

19. The system of claim 9, wherein the active ratio is a ratio of atrial cycle time/ventricular cycle time of an active heartbeat.

20. The system of claim 9, wherein the processor is capable of determining an atrial repolarization period, the atrial repolarization period being part of the atrial cycle time.

21. The system of claim 20, wherein the processor is further capable of determining an atrial depolarization period, the atrial depolarization period being part of the atrial cycle time.

22. The system of claim 9, wherein the processor is capable of determining a ventricular depolarization period, the ventricular depolarization period being part of the ventricular cycle time.

23. The system of claim 22, wherein the processor is capable of determining a ventricular repolarization period, the ventricular repolarization period being part of the ventricular cycle time.

24. The system of claim 9, wherein the processor is configured to perform digital signal processing.

25. The system of claim 9, wherein the processor is capable of predicting an arrhythmia based upon the comparison of the hemodynamic baseline ratio and the active ratio.

26. The system of claim 9, wherein the processor includes an algorithm for operating upon the comparison of the hemodynamic baseline ratio and the active ratio.

27. The system of claim 9, wherein the processor is capable of recording a plurality of active ratios each based upon atrial cycle times and ventricular cycle times of a plurality of heartbeats, respectively.

28. The system of claim 27, wherein the processor is capable of establishing an active ratio trend based upon the plurality of active ratios.

29. The system of claim 28, wherein the processor is capable of comparing the active ratio trend with the hemodynamic baseline ratio and determining a corresponding corrective action.

30. An implantable medical device system for regulating a heart of a patient, the system comprising:

first sensing means for sensing an atrial cycle time of a heartbeat;

second sensing means for sensing a ventricular cycle time of a heartbeat;

processing means for generating an active ratio based upon the sensed atrial cycle time and the sensed ventricular cycle time of an active heartbeat;

comparing means for comparing the active ratio to a hemodynamic baseline ratio;

analyzing means for determining a corrective action based upon a comparison of the active ratio and the hemodynamic baseline ratio; and

heart therapy means for delivering a therapy to the patient based upon the determined corrective action.

31. The system of claim 30, wherein the heart therapy means comprises means for delivering electrical stimulation to the patient.

32. The system of claim 30, wherein the heart therapy means comprises means for delivering a drug to the patient.

33. The system of claim 30, wherein the first sensing means includes means for sensing an atrial repolarization period of a heartbeat.

34. The system of claim 33, wherein the first sensing means includes means for sensing an atrial depolarization period of a heartbeat.

35. The system of claim 34, wherein the first sensing means includes a PT sensor.

36. The system of claim 30, wherein the second sensing means includes means for sensing a ventricular depolarization period of a heartbeat.

37. The system of claim 36, wherein the second sensing means includes means for sensing a ventricular repolarization period of a heartbeat.

38. The system of claim 37, wherein the second sensing means includes a QT sensor.

39. The system of claim 30, wherein the first sensing means and the second sensing means include digital signal processing means.

40. The system of claim 30, wherein the analyzing means includes a microprocessor and an algorithm for evaluating the comparison of the active ratio and the hemodynamic baseline ratio.

41. The system of claim 38, further comprising:

determining means for determining the hemodynamic baseline ratio.

42. The system of claim 41, wherein the determining means includes means for establishing an atrial cycle time and a ventricular cycle time of a hemodynamic heartbeat.

43. The system of claim 42, wherein the determining means processes information from the first and second sensing means to determine the hemodynamic baseline ratio.

44. The system of claim 43, wherein the determining means includes means for analyzing a plurality of preliminary ratios each based upon a preliminary atrial cycle time and a preliminary ventricular cycle time for respective preliminary heartbeats.

45. The system of claim 30, wherein the active ratio is sensed atrial cycle time/sensed ventricular cycle time.

46. The system of claim 30, further comprising:

recording means for recording a plurality of active ratios.

47. The system of claim 46, further comprising:

correlating means for correlating the plurality of active ratios in comparison to the hemodynamic baseline ratio.

48. A method for applying therapy with an implantable medical device to a heart of a patient, the method comprising:

sensing an atrial cycle time for a first heartbeat;

sensing a ventricular cycle time for the first heartbeat;

generating an active ratio for the first heartbeat based upon the sensed atrial cycle time and the sensed ventricular cycle time;

comparing the active ratio to a hemodynamic baseline ratio;

determining a corrective action based upon the comparison; and

applying a therapy to the heart to effectuate the determined corrective action.

49. The method of claim 48, wherein sensing an atrial cycle time includes sensing an atrial repolarization period for the first heartbeat.

50. The method of claim 49, wherein sensing the atrial repolarization period includes digitizing an ECG signal for the first heartbeat.

51. The method of claim 49, wherein sensing the atrial cycle time further includes sensing an atrial depolarization period for the first heartbeat.

52. The method of claim 51, wherein sensing the atrial cycle time includes determining a time period from initiation of the atrial depolarization period to termination of the atrial repolarization period.

53. The method of claim 48, wherein sensing a ventricular cycle time includes sensing a ventricular depolarization period for the first heartbeat.

54. The method of claim 53, wherein sensing a ventricular cycle time further includes sensing a ventricular repolarization period for the first heartbeat.

55. The method of claim 54, wherein sensing the ventricular cycle time includes determining a time period from initiation of the ventricular depolarization period to termination of the ventricular repolarization period.

56. The method of claim 48, wherein generating an active ratio includes determining a ratio of atrial cycle time/ventricular cycle time for the first heartbeat.

57. The method of claim 48, further comprising:

establishing the hemodynamic baseline ratio.

58. The method of claim 57, wherein establishing the hemodynamic baseline ratio includes:

determining an atrial cycle time for a hemodynamic heartbeat; and

determining a ventricular cycle time for a hemodynamic heartbeat.

59. The method of claim 58, wherein determining an atrial cycle time for a hemodynamic heartbeat includes determining an atrial repolarization period for a hemodynamic heartbeat.

60. The method of claim 58, wherein establishing the hemodynamic baseline ratio further includes:

determining a ratio of atrial cycle time/ventricular cycle time for a hemodynamic heartbeat.

61. The method of claim 58, wherein establishing the hemodynamic baseline ratio further includes:

monitoring a plurality of preliminary heartbeats;

determining an atrial cycle time for each of the preliminary heartbeats;

determining a ventricular cycle time for each of the preliminary heartbeats;

determining a preliminary ratio for each of the preliminary heartbeats, wherein each preliminary ratio is based upon the respective atrial and ventricular cycle times of the preliminary heartbeats; and

correlating the preliminary ratios to establish the hemodynamic baseline ratio.

62. The method of claim 57, wherein the hemodynamic baseline ratio is a predetermined value.

63. The method of claim 48, wherein comparing the active ratio to the hemodynamic baseline ratio includes identifying an instability in an atrium of the patient.

64. The method of claim 48, wherein comparing the active ratio to a hemodynamic baseline ratio includes identifying an instability in a ventricle of the patient.

65. The method of claim 48, wherein comparing the active ratio to the hemodynamic baseline ratio includes identifying onset of an arrhythmia.

66. The method of claim 48, further comprising determining a plurality of active ratios based upon atrial cycle time and ventricular cycle time for a plurality of heartbeats, respectively.

67. The method of claim 66, further comprising formulating an activity trend for the heart based upon the plurality of active ratios.

68. The method of claim 67, further comprising determining an optimal lower rate limit for the heart based upon the activity trend.

69. The method of claim 48, wherein applying a therapy to the heart includes delivering an electrical stimulation to the patient.

70. The method of claim 48, wherein applying a therapy to the heart includes delivering a drug to the patient.