Method and apparatus for the monitoring and treatment of spontaneous cardiac arrhythmias

• US 20030114887A1
• Filed: 01/31/2003
• Published: 06/19/2003
• Est. Priority Date: 09/12/2000
• Status: Active Grant

• Current Assignee: Fanuc Ltd (Fanuc Corporation)
• Original Assignee: Fanuc Ltd (Fanuc Corporation)
• Inventors: KenKnight, Bruce H.
• Granted Patent: US 7,346,392 B2
• Time in Patent Office: Days
• US Class Current: 607/5
• CPC Class Codes: A61N 1/3622 comprising two or more electrodes co-operating with different heart regions
• CPC Class Codes: A61N 1/3956 Implantable devices for applying electric shocks to the heart, e.g. for cardioversion

Abstract

An implantable apparatus for the detection and monitoring of spontaneous cardiac electrogram features in a comprises a cardiac monitoring device and a plurality of subcutaneous cardiac sensing electrodes electrically connected to the monitoring device. The sensing electrodes are configured for sensing cardiac electrogram features when implanted in spatially separate locations in a patient. A storage device contained within the monitoring device is operably associated with the subcutaneous electrodes and stores the cardiac electrogram features. Preferably, the plurality of subcutaneous electrodes are carried by a single elongate lead. A downloading device such as telemetry apparatus or transcutaneous electrical connectors may be provided so that the stored information can be downloaded to a separate apparatus external to the patient. In a preferred embodiment, the apparataus is a defibrillator. Methods of using such apparatus are also disclosed.

Claims

1. An implantable apparatus for the detection and monitoring of spontaneous cardiac electrogram features in a patient, said apparatus comprising:

an implantable cardiac monitoring device;

a plurality of subcutaneous cardiac sensing electrodes electrically connected to said monitoring device, said sensing electrodes configured for sensing cardiac electrogram features when implanted in spatially separate locations in a patient; and

storage means contained within said monitoring device and operably associated with said subcutaneous electrodes for storing said cardiac electrogram features.

2. An apparatus according to claim 1, wherein said plurality of subcutaneous electrodes are carried by a single elongate lead.

3. An apparatus according to claim 2, wherein said implantable cardiac monitoring device is configured for implantation in the left pre-pectoral position, and said elongate lead is configured for extending from the xiphoid process of the sternum of said patient to said implantable cardiac arrhythmia monitoring device.

4. An apparatus according to claim 3, wherein one of said subcutaneous electrodes is configured on said lead for positioning adjacent the xiphoid process of the patient, and another of said subcutaneous electrodes is configured on said lead for positioning adjacent the left axilla of the patient.

5. An apparatus according to claim 1, wherein said storage means comprises a cardiac electrogram feature detector.

6. An apparatus according to claim 5, wherein said detector is selected from the group consisting of QT interval detectors, PR interval detectors, ST interval detectors, RT interval detectors, T wave duration detectors, QRS duration detectors, R wave morphology detectors, and T wave morphology detectors.

7. An apparatus according to claim 1, further comprising downloading means operatively associated with said storage means for transferring stored information on the electrical activity of the heart of said patient from said implantable cardiac monitoring device to a separate apparatus external to said patient.

8. An apparatus according to claim 7, wherein said downloading means is selected from the group consisting of telemetry apparatus and transcutaneous electrical connectors.

9. A method for detecting cardiac electrogram features in a patient in need thereof, comprising:

providing a plurality of subcutaneous sensing electrodes implanted in spatially separate locations in said patient;

providing an implantable cardiac monitoring device operably associated with said subcutaneous sensing electrodes;

detecting cardiac electrogram features through said plurality of sensing electrodes; and

storing said detected cardiac electrogram features in said monitoring device.

10. A method according to claim 9, further comprising the step of downloading said stored electrical activity to a separate apparatus external to said patient.

11. A method according to claim 9, further comprising the steps of:

analyzing said stored electrical activity following said downloading step; and

then

generating a therapeutic recommendation for managing cardiac arrhythmia for said patient based on said stored electrical activity.

12. A method according to claim 9, wherein said plurality of subcutaneous electrodes are carried by a single elongate lead.

13. A method according to claim 12, wherein said elongate lead extends from the xiphoid process of the sternum of said patient to a cardiac monitoring device implanted in the left pre-pectoral position in said patient.

14. A method according to claim 13, wherein one of said subcutaneous electrodes is positioned adjacent the xiphoid process of the patient, and another of said subcutaneous electrodes is positioned adjacent the left axilla of the patient.

15. A method according to claim 9, wherein said detecting step comprises the step of detecting an event selected from the group consisting of QT interval, PR interval, ST interval, RT interval, T wave duration, QRS duration, R wave morphology, and T wave morphology.

16. An implantable defibrillation apparatus that detects and monitors spontaneous cardiac electrogram features in a patient, said apparatus comprising:

an implantable cardiac defibrillator;

a plurality of subcutaneous cardiac sensing electrodes electrically connected to said defibrillator, said sensing electrodes configured for sensing cardiac electrogram features when implanted in spatially separate locations in a patient;

at least one elongate transveneous catheter flexibly configured for insertion into the heart of said patient, said catheter carrying at least one defibrillation electrode and said catheter connected to said defibrillator;

a detector carried within said defibrillator and operably associated with said sensing electrodes and said at least one defibrillation electrode, said detector configured for detecting the likelihood of a spontaneous cardiac arrhythmia and delivering a treatment pulse through said at least on defibrillation electrode.

17. An apparatus according to claim 16, wherein said defibrillation electrode is a ventricular defibrillation electrode.

18. An apparatus according to claim 16, wherein said defibrillation electrode is an atrial defibrillation electrode.

19. An apparatus according to claim 16, wherein said plurality of subcutaneous electrodes are carried by a single elongate lead.

20. An apparatus according to claim 16, said elongate lead further carrying at least one defibrillation electrode.

21. An apparatus according to claim 20, wherein said defibrillator is configured for implantation in the left pre-pectoral position, and said elongate lead is configured for extending from the xiphoid process of the sternum of said patient to said implantable cardiac arrhythmia monitoring device.

22. An apparatus according to claim 21, wherein one of said subcutaneous electrodes is configured on said lead for positioning adjacent the xiphoid process of the patient, and another of said subcutaneous electrodes is configured on said lead for positioning adjacent the left axilla of the patient.

23. An apparatus according to claim 21, further comprising storage means contained within said defibrillator and operably associated with said sensing electrodes for storing said cardiac electrogram features.

24. An apparatus according to claim 23, wherein said storage means comprises a cardiac electrogram feature detector.

25. An apparatus according to claim 24, wherein said detector is selected from the group consisting of QT interval detectors, PR interval detectors, ST interval detectors, RT interval detectors, T wave duration detectors, QRS duration detectors, R wave morphology detectors, and T wave morphology detectors.

26. An apparatus according to claim 23, further comprising downloading means operatively associated with said storage means for transferring stored information on the electrical activity of the heart of said patient from said implantable cardiac arrhythmia monitoring device to a separate apparatus external to said patient.

27. An apparatus according to claim 26, wherein said downloading means is selected from the group consisting of telemetry apparatus and transcutaneous electrical connectors.

28. A defibrillation method that includes detecting cardiac electrogram features in a patient in need thereof, said method comprising:

providing a plurality of subcutaneous sensing electrodes implanted in spatially separate locations in said patient;

providing an implantable cardiac defibrillator operably associated with said subcutaneous sensing electrodes detecting cardiac electrogram features through said plurality of sensing electrodes;

providing at least one elongate transveneous catheter inserted into the heart of said patient, said catheter connected to said defibrillator and carrying at least one defibrillation electrode;

detecting electrical activity of the heart of said patient through said subcutaneous sensing electrodes;

determining the likelihood of a spontaneous cardiac arrhythmia from said detected electrical activity; and

then

administering a therapeutic pulse to said heart through said at least one defibrillation electrode upon the determination of a likelihood of occurrence of a spontaneous cardiac arrhythmia.

29. A method according to claim 28, wherein said therapeutic pulse is an atrial therapeutic pulse.

30. A method according to claim 28, wherein said therapeutic pulse is a ventricular therapeutic pulse.

31. A method according to claim 28, further comprising the step of storing said detected cardiac electrogram features in said defibrillator.

32. A method according to claim 31, further comprising the step of downloading said stored electrical activity to an external device.

33. A method according to claim 31, further comprising the steps of:

analyzing said stored electrical activity following said downloading step; and

then

generating a therapeutic recommendation for managing cardiac arrhythmia for said patient based on said stored electrical activity.

34. A method according to claim 28, wherein said plurality of subcutaneous electrodes are carried by a single elongate lead.

35. A method according to claim 34, wherein said elongate lead extends from the xiphoid process of the sternum of said patient to a defibrillator implanted in the left pre-pectoral position in said patient.

36. A method according to claim 35, wherein one of said subcutaneous electrodes is positioned adjacent the xiphoid process of the patient, and another of said subcutaneous electrodes is positioned adjacent the left axilla of the patient.

37. A method according to claim 28, wherein said detecting step comprises the step of detecting an event selected from the group consisting of QT interval, PR interval, ST interval, RT interval, T wave duration, QRS duration, R wave morphology, and T wave morphology.

38. A subcutaneous lead useful for an implantable apparatus for the detection and treatment of spontaneous cardiac arrhythmia in a patient in need thereof, said implantable apparatus including an implantable cardiac arrhythmia management device for implantation in the left pre-pectoral position in said patient, said elongate lead comprising:

an elongate lead configured for extending from the xiophoid process of the sternum of said patient to said implantable cardiac arrhythmia management device when implanted said device is implanted in the left pre-pectoral position in said patient; and

a pluarality of subcutaneous sensing electrodes connected to said lead in a spaced-apart configuration thereon.

39. A subcutaneous lead according to claim 38, wherein one of said subcutaneous electrodes is configured on said lead for positioning adjacent the xiophoid process of the patient.

40. A subcutaneous lead according to claim 38, wherein one of said subcutaneous electrodes is configured on said lead for positioning adjacent the left axilla of the patient.

41. A subcutaneous lead according to claim 38, said lead further carrying at least one defibrillation electrode.