Implantable medical device for treating neurological conditions with an initially disabled cardiac therapy port and leadless ECG sensing

• US 20080269842A1
• Filed: 04/27/2007
• Published: 10/30/2008
• Est. Priority Date: 04/27/2007
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Werder, Jonathan C., Giftakis, Jonathon E., Graves, Nina M., Panken, Eric J.
• Granted Patent: US 8,000,788 B2
• Time in Patent Office: Days
• US Class Current: 607/62
• CPC Class Codes: A61N 1/36082 Cognitive or psychiatric applications, e.g. dementia or Alzheimer's disease
• CPC Class Codes: A61N 1/36114 Cardiac control, e.g. by vagal stimulation stimulating the heart A61N1/362
• CPC Class Codes: A61N 1/36585 controlled by two or more physical parameters
• CPC Class Codes: A61N 1/37 Monitoring; Protecting
• CPC Class Codes: A61N 1/37512 Pacemakers
• CPC Class Codes: A61N 1/3756 Casings with electrodes thereon, e.g. leadless stimulators

Abstract

An implantable medical device such as an implantable pulse generator that includes EEG sensing for monitoring and treating neurological conditions, and leadless ECG sensing for monitoring cardiac signals. The device includes a connector block with provisions for cardiac leads which may be used/enabled when needed. If significant co-morbid cardiac events are observed in patients via the leadless ECG monitoring, then cardiac leads may be subsequently connected for therapeutic use.

Claims

1. A device-implemented method comprising:

implanting into a patient a medical device having at least three leadless electrodes located on a housing of the medical device and a cardiac port, the medical device having a processor communicatively coupled to the cardiac port and the three leadless electrodes;

disabling the cardiac port either before or after implantation of the device;

enabling cardiac sensing from two of the three leadless electrodes either before or after implantation of the device;

assessing the cardiac sensing for the presence of cardiac events that may require cardiac therapy;

if no cardiac events that may require therapy are identified, maintain cardiac monitoring using the leadless electrodes; and

if a cardiac event that may require cardiac therapy is identified, enabling the cardiac port.

2. The method of claim 1 further comprising the step of, if a cardiac event that may require cardiac therapy is identified, coupling proximal ends of cardiac leads to the cardiac port and positioning distal ends of the leads in, or in close proximity to, the heart.

3. The method of claim 2 further comprising the step of, if a cardiac event that may require cardiac therapy is identified, disabling cardiac sensing from the two leadless electrodes and enabling cardiac sensing from the cardiac leads.

4. The method of claim 2 further comprising a step of, if a cardiac event that may require cardiac therapy is identified, selecting either the cardiac port or the leadless electrodes for cardiac sensing.

5. The method of claim 4 wherein if the cardiac port is selected, performing direct cardiac sensing with the cardiac leads and, if required, delivering cardiac therapy with the cardiac leads.

6. The method of claim 4 wherein if the leadless electrodes are selected, performing indirect cardiac sensing with the leadless electrodes and, if required, delivering cardiac therapy with the cardiac leads.

7. The method of claim 4 further comprising a step of defining cardiac therapy parameters before the step of selecting either the cardiac port or the leadless electrodes for cardiac sensing.

8. The method of claim 5 further comprising a step of enabling brain state control of the delivered cardiac therapy.

9. The method of claim 1 further comprising a step of providing a brain lead having a proximal end coupled to a brain port located on the housing, the lead having a distal end with at least one electrode wherein the distal end is implanted in a human at a location to sense electrical signals from the human'"'"'s brain;

and

enabling the leadless electrode not previously enabled for cardiac sensing as an EEG reference electrode adapted to sense the electrical signals from the human'"'"'s brain, wherein the processor includes sensing circuitry adapted to receive and process electrical signals received by the distal end of the lead and the enabled EEG reference electrode.

10. The method of claim 9 wherein the processor also includes a pulse generator wherein the at least one electrode on the distal end of the brain lead is adapted to receive stimulating pulses from the pulse generate and deliver pulses to tissue in which the at least one electrode is implanted.

11. The method of claim 10 wherein the leadless electrode not previously enabled for cardiac sensing is a remote electrode coupled to the pulse generator.

12. The method of claim 11 wherein the remote electrode is a reference electrode adapted to sense electrical signals.

13. The method of claim 10 further comprising a second electrode located at the distal end of the brain lead coupled to the pulse generator wherein the at least one electrode and the second electrode may deliver bipolar stimulation.

14. The method of claim 10 wherein the remote electrode is an indifferent electrode.

15. The method of claim 14 wherein the at least one electrode may deliver monopolar stimulation.

16. The method of claim 2 further comprising the step of delivering cardiac therapy with the cardiac leads.

17. A device-implemented method comprising:

implanting into a patient a medical device having a cardiac sensing port and a cardiac therapy port, the medical device having a processor communicatively coupled to the cardiac sensing and therapy ports;

disabling the cardiac therapy port either before or after implantation of the device;

coupling proximal ends of cardiac leads to the cardiac sensing port and positioning distal ends of the leads in, or in close proximity to, the heart;

enabling cardiac sensing from the cardiac sensing port either before or after implantation of the device;

assessing the cardiac sensing for the presence of cardiac events that may require cardiac therapy;

if no cardiac events that may require therapy are identified, maintain cardiac monitoring using the cardiac sensing port; and

if a cardiac event that may require cardiac therapy is identified, enabling the cardiac therapy port.

18. The method of claim 17 wherein the cardiac sensing port and cardiac therapy port are the same port.

19. The method of claim 18 further comprising the step of delivering cardiac therapy with the cardiac leads.

20. The method of claim 17 further comprising a step of providing at least one leadless electrode located on a housing of the device and providing a brain lead having a proximal end coupled to a brain port located on the housing, the lead having a distal end with at least one electrode wherein the distal end is implanted in a human at a location to sense electrical signals from the human'"'"'s brain;

and

enabling the leadless electrode as an EEG reference electrode adapted to sense the electrical signals from the human'"'"'s brain, wherein the processor includes sensing circuitry adapted to receive and process electrical signals received by the distal end of the lead and the leadless electrode.

21. The method of claim 20 wherein the processor also includes a pulse generator wherein the at least one electrode on the distal end of the brain lead is adapted to receive stimulating pulses from the pulse generate and deliver pulses to the at least one electrode.

22. The method of claim 21 wherein the leadless electrode not previously enabled for cardiac sensing is a remote electrode coupled to the pulse generator.

23. The method of claim 22 wherein the remote electrode is a reference electrode adapted to sense electrical signals.

24. The method of claim 21 further comprising a second electrode located at the distal end of the brain lead coupled to the pulse generator wherein the at least one electrode and the second electrode may deliver bipolar stimulation.

25. The method of claim 21 wherein the remote electrode is an indifferent electrode.

26. The method of claim 25 wherein the at least one electrode may deliver monopolar stimulation.

27. An apparatus for leadless acquisition of electrocardiographic data comprising:

a hermetically sealed implantable device including at least three leadless electrodes located on a housing of the medical device and a cardiac therapy port wherein two of the three electrodes are enabled for cardiac sensing;

a therapy module coupled to the cardiac therapy port for providing therapeutic output to the heart;

a processor in communication with the two electrodes enabled for cardiac sensing and the cardiac port, the processor configured to perform the following;

assessing the cardiac sensing for the presence of cardiac events that may require cardiac therapy, and

if no cardiac event that may require cardiac therapy is identified, maintaining cardiac monitoring using the leadless electrodes; and

if a cardiac event that may require cardiac therapy is identified, enabling the cardiac therapy port so that cardiac leads may subsequently be coupled to the cardiac port.

28. The apparatus of claim 27 further comprising cardiac leads coupled to the cardiac therapy port.

29. The apparatus of claim 27 wherein the processor is configured to disable cardiac sensing from the two leadless electrodes and enable cardiac sensing from the cardiac leads, if a cardiac event that may require cardiac therapy is identified.

30. The apparatus of claim 27 wherein the processor is configured to select either the cardiac port or the leadless electrodes for cardiac sensing, if a cardiac event that may require cardiac therapy is identified.

31. The apparatus of claim 30 wherein the processor is configured to perform direct cardiac sensing with the cardiac leads if the cardiac port is selected and, if required, deliver cardiac therapy with the cardiac leads.

32. The apparatus of claim 30 wherein the processor is configured to perform indirect cardiac sensing with the leadless electrodes if the leadless electrodes are selected, and, if required, deliver cardiac therapy with the cardiac leads.

33. The apparatus of claim 27 wherein the processor is configured to enable brain state control of the delivered cardiac therapy.

34. The apparatus of claim 27 further comprising a brain lead having a proximal end coupled to a brain port located on the housing, the lead having a distal end with at least one electrode wherein the distal end is implanted in a human at a location to sense electrical signals from the human'"'"'s brain;

wherein the processor is configured to enable the leadless electrode not previously enabled for cardiac sensing as an EEG reference electrode adapted to sense the electrical signals from the human'"'"'s brain, wherein the processor includes sensing circuitry adapted to receive and process electrical signals received by the distal end of the lead and the enabled EEG electrode.

35. The apparatus of claim 34 wherein the processor also includes a pulse generator wherein the at least one electrode on the distal end of the brain lead is adapted to receive stimulating pulses from the pulse generate and deliver pulses to the at least one electrode.

36. The apparatus of claim 35 wherein the leadless electrode not previously enabled for cardiac sensing is a remote electrode coupled to the pulse generator.

37. The apparatus of claim 36 wherein the remote electrode is a reference electrode adapted to sense electrical signals.

38. The apparatus of claim 35 further comprising a second electrode located at the distal end of the brain lead coupled to the pulse generator wherein the at least one electrode and the second electrode may deliver bipolar stimulation.

39. The apparatus of claim 35 wherein the remote electrode is an indifferent electrode.

40. The apparatus of claim 39 wherein the at least one electrode may deliver monopolar stimulation.