METHOD AND APPARATUS FOR DETECTING ARRHYTHMIAS IN A SUBCUTANEOUS MEDICAL DEVICE

Abstract

A method and apparatus for detecting a cardiac event in a medical device that includes sensing cardiac signals from a plurality of electrodes, the plurality of electrodes forming a first sensing vector and a second sensing vector, initiating charging of an energy storage device in response to the sensed cardiac signals, and determining whether a predetermined number of morphologies associated with cardiac signals sensed along the first sensing vector and the second sensing vector during corresponding sensing windows are indicative of the cardiac event.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

Aspects and features of the present invention will be appreciated as the same becomes better understood by reference to the following detailed description of the embodiments of the invention when considered in connection with the accompanying drawings, wherein:

FIG. 1 is a schematic diagram of an exemplary subcutaneous device in which the present invention may be usefully practiced;

FIG. 3 is an exemplary schematic diagram of electronic circuitry within a hermetically sealed housing of a subcutaneous device of the present invention;

FIG. 4 is a schematic diagram of signal processing aspects of a subcutaneous device according to an exemplary embodiment of the present invention;

FIG. 5 is a state diagram of detection of arrhythmias in a subcutaneous device according to an embodiment of the present invention;

FIG. 6 is a flow chart of a method for detecting arrhythmias in a subcutaneous device according to an embodiment of the present invention;

FIGS. 7A-7I are flow charts of a method for detecting arrhythmias in a subcutaneous device according to an embodiment of the present invention;

FIG. 8 is a graphical representation of sensing of cardiac activity according to an embodiment of the present invention;

FIG. 9A is a graphical representation of a determination of whether a signal is corrupted by muscle noise according to an embodiment of the present invention;

FIG. 9B is a flowchart of a method of determining whether a signal is corrupted by muscle noise according to an embodiment of the present invention;

FIG. 9C is a flowchart of a method of determining whether a signal is corrupted by muscle noise according to an embodiment of the present invention;

FIG. 10 is a graphical representation of a VF shock zone according to an embodiment of the present invention; and

FIGS. 11A and 11B are graphical representations of the determination of whether an event is within a shock zone according to an embodiment of the present invention.

Claims

1. A method of detecting a cardiac event in a medical device, comprising: sensing cardiac signals from a plurality of electrodes;initiating charging of an energy storage device in response to the sensed cardiac signals; anddetermining, during charging of the energy storage device, whether a morphology of a signal associated with cardiac signals sensed during a sensing window is indicative of the cardiac event.

2. The method of claim 1, wherein the plurality of electrodes are positioned non-transvenously.

3. The method of claim 1, further comprising: determining, in response to the morphology being indicative of the cardiac event, whether the charging of the energy storage device is completed; anddetermining, in response to the charging of the energy storage device being completed, whether the cardiac event is confirmed in response to morphologies of cardiac signals sensed during a first plurality of sensing windows.

4. The method of claim 3, further comprising determining, in response to the cardiac event not being confirmed, whether morphologies of cardiac signals sensed during a second plurality of sensing windows are indicative of the cardiac event.

5. The method of claim 1, further comprising: aborting the charging of the energy storage device in response to morphologies of cardiac signals sensed during a predetermined number of a first plurality of sensing windows not corresponding to the cardiac event; anddetermining, in response to subsequent cardiac signals sensed during a second plurality of sensing windows, whether morphologies of cardiac signals sensed during the second plurality of sensing windows are indicative of the cardiac event.

6. The method of claim 1, wherein the sensing window is between approximately 0.5 and 10 seconds.

7. A method of detecting a cardiac event in a medical device, comprising: sensing cardiac signals from a plurality of electrodes, the plurality of electrodes forming a first sensing vector and a second sensing vector;initiating charging of an energy storage device in response to the sensed cardiac signals; anddetermining whether a predetermined number of morphologies associated with cardiac signals sensed along the first sensing vector and the second sensing vector during corresponding sensing windows are indicative of the cardiac event.

8. The method of claim 7, wherein the plurality of electrodes are positioned non-transvenously.

9. The method of claim 7, wherein the determining comprises determining whether the sensed cardiac signal associated with the most recent two sensing windows for both the first sensing vector and the second sensing vector is indicative of the cardiac event.

10. The method of claim 7, further comprising: determining whether the charging of the energy storage device is completed; anddetermining, in response to the charging of the energy storage device being completed, whether the cardiac event is confirmed in response to a cardiac signal sensed along the first sensing vector and the second sensing vector during a plurality of sensing windows.

11. The method of claim 10, wherein the cardiac event is confirmed in response to the cardiac signal sensed along both the first sensing vector and the second sensing vector during at least five of the last eight sensing windows and at least two of the last three sensing windows of the plurality of sensing windows corresponding to the cardiac event.

12. The method of claim 11, wherein determining whether the cardiac event is confirmed further comprises determining whether a cardiac signal sensed during a most recent sensing window of the plurality of sensing windows corresponds to the cardiac event for at least one of the first sensing vector and the second sensing vector.

13. The method of claim 10, further comprising determining, in response to the cardiac event not being confirmed, whether state transition requirements are satisfied, the state transition requirements corresponding to whether the cardiac signal sensed during two of the last three sensing windows, three of the last eight sensing windows, and the most recent sensing window of the plurality of sensing windows correspond to the cardiac event along both the first sensing vector and the second sensing vector.

14. The method of claim 13, further comprising determining, in response to the state transition requirements being satisfied, whether redetection requirements associated with cardiac signals sensed during sensing windows of the plurality of sensing windows are satisfied for both the first sensing vector and the second sensing vector.

15. The method of claim 14, wherein the redetection requirements correspond to determining whether the cardiac signal sensed during two of the last three sensing windows of the plurality of sensing windows correspond to the cardiac event for both the first sensing vector and the second sensing vector.

16. The method of claim 7, further comprising: aborting the charging of the energy storage device in response to cardiac signals sensed during a predetermined number of a plurality of the sensing windows not corresponding to the cardiac event; anddetermining, in response to cardiac signals sensed during sensing windows of the plurality of sensing windows, whether state transition requirements are satisfied.

17. The method of claim 16, wherein the state transition requirements correspond to determining whether the cardiac signal sensed during two of the last three sensing windows, three of the last eight sensing windows, and the most recent sensing window of the plurality of sensing windows correspond to the cardiac event for both the first sensing vector and the second sensing vector.

18. The method of claim 7, wherein the sensing window is between approximately 0.5 and 10 seconds.

19. A medical device for detecting a cardiac event and delivering a corresponding therapy, the device comprising: a plurality of electrodes sensing cardiac signals, the plurality of electrodes forming a first sensing vector and a second sensing vector;an energy storage device; anda control unit to determine whether a predetermined number of morphologies associated with cardiac signals sensed along the first sensing vector and the second sensing vector during corresponding sensing windows are indicative of the cardiac event and initiating charging of the energy storage device in response to the cardiac event being indicated.

20. The device of claim 19, wherein the plurality of electrodes are positioned non-transvenously.

21. The device of claim 19, wherein the control unit determines whether the sensed cardiac signal associated with the most recent two sensing windows for both the first sensing vector and the second sensing vector is indicative of the cardiac event.

22. The device of claim 19, wherein the control unit determines whether the charging of the energy storage device is completed, and determines, in response to the charging of the energy storage device being completed, whether the cardiac event is confirmed in response to a cardiac signal sensed along the first sensing vector and the second sensing vector during a plurality of the sensing windows.

23. The device of claim 22, wherein the control unit determines the cardiac event is confirmed in response to the cardiac signal sensed along both the first sensing vector and the second sensing vector during at least five of the last eight sensing windows and at least two of the last three sensing windows of the plurality of sensing windows correspond to the cardiac event.

24. The device of claim 23, wherein the control unit determines whether a cardiac signal sensed during a most recent sensing window of the plurality of sensing windows corresponds to the cardiac event for at least one of the first sensing vector and the second sensing vector.

25. The device of claim 22, wherein the control unit determines, in response to the cardiac event not being confirmed, whether state transition requirements are satisfied, the state transition requirements corresponding to whether the cardiac signal sensed during two of the last three sensing windows, three of the last eight sensing windows, and the most recent sensing window of a plurality of the sensing windows correspond to the cardiac event along both the first sensing vector and the second sensing vector.

26. The device of claim 25, wherein the control unit determines, in response to the state transition requirements being satisfied, whether redetection requirements associated with cardiac signals sensed during sensing windows of the plurality of sensing windows are satisfied for both the first sensing vector and the second sensing vector, and wherein the redetection requirements correspond to determining whether the cardiac signal sensed during two of the last three sensing windows of the plurality of sensing windows correspond to the cardiac event for both the first sensing vector and the second sensing vector.

27. The device of claim 19, wherein the control unit abort the charging of the energy storage device in response to cardiac signals sensed during a predetermined number of a plurality of sensing windows not corresponding to the cardiac event, and determines, in response to cardiac signals sensed during sensing windows of the plurality of sensing windows, whether state transition requirements are satisfied, and wherein the state transition requirements correspond to determining whether the cardiac signal sensed during two of the last three sensing windows, three of the last eight sensing windows, and the most recent sensing window of the plurality of sensing windows correspond to the cardiac event for both the first sensing vector and the second sensing vector.

28. The device of claim 19, wherein the sensing window is between approximately 0.5 and 10 seconds.

29. A medical device for detecting a cardiac event and delivering a corresponding therapy, the device comprising: means for sensing cardiac signals from a plurality of electrodes;means for initiating charging of an energy storage device in response to the sensed cardiac signals; andmeans for determining, during charging of the energy storage device, whether a morphology of a signal associated with cardiac signals sensed during a sensing window is indicative of the cardiac event.

30. The device of claim 29, wherein the plurality of electrodes are positioned non-transvenously.

31. The device of claim 29, further comprising: means for determining, in response to the morphology being indicative of the cardiac event, whether the charging of the energy storage device is completed; andmeans for determining, in response to the charging of the energy storage device being completed, whether the cardiac event is confirmed in response to morphologies of cardiac signals sensed during a plurality of sensing windows.

32. The device of claim 31, further comprising means for determining, in response to the cardiac event not being confirmed, whether state transition requirements are satisfied, the state transition requirements being associated with morphologies of cardiac signals sensed during a plurality of sensing windows.

32. The device of claim 29, further comprising: means for aborting the charging of the energy storage device in response to morphologies of cardiac signals sensed during a predetermined number of a first plurality of predetermined sensing windows not corresponding to the cardiac event; andmeans for determining, in response to cardiac signals sensed during sensing windows of a second plurality of sensing windows, whether state transition requirements are satisfied, the state transition requirements being associated with morphologies of cardiac signals sensed during the sensing windows of the second plurality of sensing windows.