Implantable heart stimulator providing long term cardiac monitoring with automatic notification

• US 8,649,864 B2
• Filed: 10/16/2007
• Issued: 02/11/2014
• Est. Priority Date: 10/16/2007
• Status: Active Grant

• Current Assignee: Biotronik SE & Company KG
• Original Assignee: Biotronik CRM Patent AG (Biotronik SE & Company KG)
• Inventors: Hastings, David F., Good, Xin, Lang, Volker
• Primary Examiner(s): Layno, Carl H
• Assistant Examiner(s): GHAND, JENNIFER LEIGH-STEWAR
• Application Number:
  US11/873,292
• Publication Number:
  US 20090099617A1
• Time in Patent Office: 2,310 Days
• Field of Search: 600/300, 607 17- 18
• US Class Current: 607/18
• CPC Class Codes: A61B 5/0538 invasively, e.g. using a catheter
• CPC Class Codes: A61B 5/686 Permanently implanted devices, e.g. pacemakers, other stimulators, biochips A61B5/6861 takes precedence
• CPC Class Codes: A61B 5/7275 Determining trends in physiological measurement data; Predicting development of a medical condition based on physiological measurements, e.g. determining a risk factor
• CPC Class Codes: A61N 1/362 Heart stimulators heart defibrillators A61N1/39
• CPC Class Codes: A61N 1/36521 the parameter being derived from measurement of an electrical impedance
• CPC Class Codes: A61N 1/368 comprising more than one electrode co-operating with different heart regions A61N1/3622, A61N1/3627 take precedence
• CPC Class Codes: A61N 1/3702 Physiological parameters A61N1/365 takes precedence; evoked response A61N1/371
• CPC Class Codes: A61N 1/37258 Alerting the patient
• CPC Class Codes: A61N 1/37282 characterised by communication with experts in remote locations using a network

Abstract

An implantable medical device that continuously measures the patient'"'"'s intracardiac ventricular impedance. Extracts cardiac performance information based on the intracardiac impedance, including amplitude, timing and variability of cardiac contraction function. The device records and analysis trends in the performance information. The device identifies changes, which exceed the selected threshold limits. In the event of an incipient crisis, the device transmits an alert message.

Claims

1. An implantable heart stimulator, comprising:

at least one electrode or at least one connector for electrodes;

at least one stimulation pulse generator connected to said at least one electrode or said at least one connector for intracardiac placement and configured to

selectively generate a stimulation pulse for delivery to at least one ventricle of a heart;

at least one sensing unit connected to said at least one electrode or said at least one connector for intracardiac placement and configured to

process electric potentials that can be picked up by an intracardiac electrode in said at least one ventricle of said heart to thus acquire an intracardiac electrocardiogram or IEGM;

at least one impedance measuring unit connected to said at least one electrode or said at least one connector for intracardiac placement and configured to

determine a unipolar ventricular impedance or conductance signal having a magnitude corresponding to intracardiac impedance of conductivity of said at least one ventricle of said heart;

a hemodynamic sensor configured to generate an output signal reflecting physical activity or hemodynamic need of a patient;

a memory unit configured to store data;

a telemetry unit configured for wireless transmission of data;

a control unit connected to said at least one stimulation pulse generator, said at least one sensing unit, said at least one impedance measuring unit and said hemodynamic sensor, and configured to

determine on a regular basis primary signals including ventricular unipolar intracardiac impedance values and physical activity values as represented by an output signal of said hemodynamic sensor; and

,

determine from said regular basis primary signals one or more values of systemic dynamics indices that include;

Peak Systolic Dynamics,

Resting Systolic Dynamics,

Systolic Reserves,

Systemic Control Power,

Systemic Control Reserves,

Cardiac Demand Balance;

wherein said indices are determined from filtering said regular basis primary signals using a calculation which combines data from said regular basis primary signals and isolates a cardiac centric performance from systemic specific performance; and

wherein said indices are configured to remove interfering and confounding factors using one or more of data selection, arithmetic correction, data filtering and normalization.

2. The implantable heart stimulator according to claim 1, wherein said peak systolic dynamics values represent a maximum amplitude of a ventricular impedance signal which is sustained for a predetermined period of time or a predetermined number of cardiac cycles as represented by said IEGM.

3. The implantable heart stimulator according to claim 2, wherein said maximum amplitude of said ventricular impedance signal is a maximum absolute value or a peak-to-peak difference of said ventricular impedance signal associated with a specific cardiac cycle or a portion of a cardiac cycle.

4. The implantable heart stimulator according to claim 2, wherein said predetermined period of time or said predetermined number of cardiac cycles is defined as a period of time wherein a threshold impedance value is exceeded, a value of which is configured to optimize state discrimination including but not limited to receiver operating characteristic (ROC) techniques.

5. The implantable heart stimulator according to claim 2, wherein said control unit is configured to determine said peak cardiac systolic dynamics values independently for ventricular paced and ventricular sensed events.

6. The implantable heart stimulator according to claim 2, wherein said control unit is configured to determine said peak systolic dynamics values independently for different types of atrial events associated with the ventricular events.

7. The implantable heart stimulator according to claim 2, wherein said control unit is configured to collect and trend said peak systolic dynamics values based on a range of time bases, with temporal resolutions equivalent but not limited to minutes, hours, days and weeks.

8. The implantable heart stimulator according to claim 1, wherein said resting systolic dynamics values represent a characteristic magnitude or amplitude of a ventricular impedance signal during a predetermined period of low physical activity as represented by an output signal of said hemodynamic sensor.

9. The implantable heart stimulator according to claim 1, wherein said resting systolic dynamics values represent a characteristic magnitude or amplitude of a ventricular impedance signal during a predetermined period of low physical activity as represented by a stable conduction rhythm.

10. The implantable heart stimulator according to claim 1, wherein said resting systolic dynamics values represent a characteristic magnitude or amplitude of a ventricular impedance signal during a predetermined period of low physical activity as represented by a specified posture.

11. The implantable heart stimulator according to claim 1, wherein said resting systolic dynamics values represent a characteristic magnitude or amplitude of a ventricular impedance signal during a predetermined period of low physical activity as represented by a specified time within the diurnal cycle.

12. The implantable heart stimulator according to claim 1, wherein said control unit is configured to determine changes in said resting systolic dynamics values with respect to prior measures of said resting systolic dynamics values or a single standard reference condition.

13. The implantable heart stimulator according to claim 1, wherein said control unit is configured to determine changes in said resting systolic dynamics values by comparing ventricular impedance curves obtained under specified conditions.

14. The implantable heart stimulator according to claim 12, wherein said control unit is configured to directly calculate change indices as an average signed or unsigned deviation of said resting systolic dynamics values from prior measures of said resting systolic cardiac dynamics values or a single standard reference condition.

15. The implantable heart stimulator according to claim 13, wherein said control unit is configured to calculate change indices by comparing extracted features of said ventricular impedance curves.

16. The implantable heart stimulator according to claim 1, wherein said control unit is configured to determine said resting systolic dynamics values independently for ventricular paced and ventricular sensed events.

17. The implantable heart stimulator according to claim 1, wherein said control unit is configured to sub classify said resting systolic dynamics values based on an associated atrial event type.

18. The implantable heart stimulator according to one of claim 1, wherein said control unit is configured to collect and trend said resting systolic dynamics values on a range of time bases, with temporal resolutions equivalent but not limited to hours, days and weeks.

19. The implantable heart stimulator according to claim 1, wherein said systolic reserves values are calculated from a distribution in ventricular impedance signals collected during periods of rest and during periods of activity as indicated by a cardiac demand sensor.

20. The implantable heart stimulator according to claim 19, wherein said control unit is configured to calculate said systolic reserves values from the difference in the medians of the activity and resting distributions divided by the half width of the resting distribution.

21. The implantable heart stimulator according to claim 19, wherein said control unit is configured to calculate said systolic reserves values from distributions of a characteristic magnitude obtained from said ventricular impedance signals.

22. The implantable heart stimulator according to claim 19, wherein said control unit is configured to calculate said systolic reserves values by comparing extracted features of the ventricular impedance curves.

23. The implantable heart stimulator according to claim 19, wherein said control unit is configured to establish a peak value for said systolic reserves values over an appropriate observational period.

24. The implantable heart stimulator according to claim 19, wherein said control unit is configured to determine peak systolic reserves values independently for ventricular paced and ventricular sensed events.

25. The implantable heart stimulator according to claim 19, wherein said control unit is configured to sub-classify said systolic reserves values based on the associated atrial event type.

26. The implantable heart stimulator according to claim 19, wherein said control unit is configured to collect and trend said systolic reserves values on a range of time bases, with temporal resolutions equivalent but not limited to days and weeks.

27. The implantable heart stimulator according to claim 1, wherein said systemic control power values represent a root means square power integrated over a frequency band which includes one or more of high frequency, low frequency and very low frequency bands associated with heart variability wherein said heart variability is configured to be derived from ventricular impedance signals.

28. The implantable heart stimulator according to claim 27, wherein said control unit is configured to determine a basal systemic control power value for specific reproducible rest conditions.

29. The implantable heart stimulator according to claim 28, wherein said specific reproducible rest condition is a specified resting period.

30. The implantable heart stimulator according to claim 28, wherein said specific reproducible rest condition is a stable conduction rhythm and a specified time within the diurnal cycle.

31. The implantable heart stimulator according to claim 27, wherein said control unit is configured to determine a basal systemic control power value as the root mean square power integrated over a frequency band which including one or more of the high frequency, low frequency and very low frequency bands associated with heart rate variability.

32. The implantable heart stimulator according to claim 31, wherein said control unit is configured to determine a band limited root mean square power as an average of absolute values of differences between outputs of two low pass filters.

33. The implantable heart stimulator according to claim 28, wherein said control unit is configured to determine said basal systemic control power value independently for ventricular paced and ventricular sensed events.

34. The implantable heart stimulator according to claim 28, wherein said control unit is configured to sub-classify said basal systemic control power values based on an associated atrial event type.

35. The implantable heart stimulator according to claim 28, wherein said control unit is configured to collect and trend said basal systemic control power values on a range of time bases, with temporal resolutions equivalent but not limited to hours, days and weeks.

36. The implantable heart stimulator according to claim 1, wherein said systemic control reserves value represents a maximum of integral values wherein each integral value is determined for one heart cycle and represents the integrated ventricular impedance signal between a Q-wave and a R-wave in the corresponding IEGM.

37. The implantable heart stimulator according to claim 36, wherein said control unit is configured to calculate said systemic control reserves values from the ventricular IEGM in a manner similar to calculation of rate adaptation.

38. The implantable heart stimulator according to claim 36, wherein said control unit is configured to determine said systemic control reserves values by determining a peak value, which was sustained for a specified period of time or number of cardiac cycles over a specified observational period.

39. The implantable heart stimulator according to claim 38, wherein said specified observational period is defined as exceeding a threshold value for a specified duration or as an average over said specified duration, a value of which is configured to optimize state discrimination including but not limited to receiver operating characteristic (ROC) techniques.

40. The implantable heart stimulator according to claim 36, wherein said control unit is configured to determine said systemic control reserves values independently for ventricular paced and ventricular sensed events.

41. The implantable heart stimulator according to claim 36, wherein said control unit is configured to sub-classify said systemic control reserves values based on an associated atrial event type.

42. The implantable heart stimulator according to claim 36, wherein said control unit is configured to collect and trend said systemic control reserves values on a range of time bases, with temporal resolutions equivalent but not limited to days and weeks.

43. The implantable heart stimulator according to claim 1, wherein said systemic demand balance value represents a ratio between a daily average heart rate elevation during periods of elevated cardiovascular demand and a daily average magnitude of one or more hemodynamic sensors.

44. The implantable heart stimulator according to claim 1, wherein said systemic cardiac demand balance value represents a time period or a number of cardiac cycles for which ventricular impedance based rate support is provided, and for which there is significant physical exertion as indicated by said hemodynamic sensor output signal.

45. The implantable heart stimulator according to claim 44, wherein said control unit is configured to determine said systemic cardiac demand balance value over multiple rate intervals spanning a programmed rate adaptive therapy range.

46. The implantable heart stimulator according to claim 45, wherein said control unit is configured to determine said systemic cardiac demand balance value relative to a total rate support for applicable rate intervals.

47. The implantable heart stimulator according to claim 43, wherein said control unit is configured to collect and trend a plurality of said systemic cardiac demand balance values on a range of time bases, with temporal resolutions equivalent but not limited to days and weeks.