Methods and apparatus for cardiac R-wave sensing in a subcutaneous ECG waveform

• US 7,027,858 B2
• Filed: 09/11/2002
• Issued: 04/11/2006
• Est. Priority Date: 09/11/2002
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Kane, Michael R., Cao, Jian, Brian, Lee B., Hurd, Spencer R.
• Primary Examiner(s): Layno, Carl
• Assistant Examiner(s): Heller, Tammie K.
• Application Number:
  US10/238,140
• Publication Number:
  US 20040049120A1
• Time in Patent Office: 1,308 Days
• Field of Search: 600515-516, 600/518, 600/521
• US Class Current: 600/521
• CPC Class Codes: A61B 5/335 using integrated circuit memory devices
• CPC Class Codes: A61B 5/352 Detecting R peaks, e.g. for synchronising diagnostic apparatus; Estimating R-R interval
• CPC Class Codes: A61B 5/364 Detecting abnormal ECG interval, e.g. extrasystoles, ectopic heartbeats
• CPC Class Codes: A61B 5/7203 for noise prevention, reduction or removal
• CPC Class Codes: A61B 5/7221 Determining signal validity, reliability or quality A61B5/7207 and A61B5/7217 take precedence

Abstract

The present invention uses a R-wave sensing algorithm that uniquely combines an automatic threshold adjustment method with a new noise rejection technique. This algorithm has significant advantages in avoiding the sensing of T-waves, P-waves, and noise/artifacts. Detecting the presence of noise bursts uses features that determine if an R-R interval adjacent to or within the noise signal is valid. Circuitry that discriminates noise signals from R-waves can use any one of several features including, but not limited to, the following: detection events occurring so close together that they are outside normal physiologic heart rates; frequency content that is wider than that of QRS complexes; amplitudes that are different than the adjacent or encompassing R-waves; and amplitudes that display greater than normal variability. The present invention employs multiple discrete thresholds optionally with different decay constants, alone or in combination with one or more substantially constant magnitude sensing threshold.

Claims

1. A method of detecting R-waves produced by a depolarization event of a heart in an ECG waveform, comprising the steps of:

programming a minimum threshold;

applying a first threshold for a first period of time;

applying a second threshold for a second period of time beginning at the end of the first period of time;

applying a third threshold for a third period of time beginning at the end of the second period of time;

sensing ECG signals emanating from near a heart with at least one electrode; and

recording each event as an R-wave, noise, an arrhythmia, or an asystole based on whether features of the sensed ECG waveform exceed or fail to exceed one or more of the minimum, first, second or third thresholds

sensing a peak amplitude of an R-wave and,

applying the peak amplitude in combination with the programmed sensitivity (PS) setting;

calculating a threshold curve; and

displaying the threshold curve in relation to a set of detected cardiac activity.

2. A method according to claim 1, wherein the first threshold operates according to a relatively slow decay time constant.

3. A method according to claim 2, wherein the relatively slow decay time constant has a value between about 0.5 seconds and about 10.0 seconds.

4. A method according to claim 3, wherein the second threshold has a decay time constant is shorter than the slow decay time constant of the first threshold.

5. A method according to claim 4, wherein the shorter decay time constant is between about 0.5 seconds and 5.0 seconds.

6. A method according to claim 5, wherein the third threshold has a decay time constant is shorter than the slow decay time constant of the first threshold.

7. A method according to claim 1, wherein the method is implemented in an analog electronic circuit, a digital electronic circuit, a hybrid electronic circuit, in a firmware memory location, or in an executable software routine.

8. A method according to claim 1, wherein the set of cardiac activity of the heart is essentially “

real-time”

cardiac activity.

9. A method according to claim 8, wherein the set of cardiac activity is filtered or rectified prior to displaying same.

10. A method according to claim 1, wherein the method is substantially completely performed by a device and said device is a one of the following:

an AED, a ILR, a pacemaker, an ICD, an IPG.

11. A method according to claim 10, further comprising the steps of automatically storing a portion of the waveform after detection of an arrhythmia or an asystole.

12. A method according to claim 11, wherein the storing step occurs based on a priority sequence for each type of arrhythmia or asystole.

13. A method according to claim 12, wherein in the event that a particular higher priority bin is full, a record scheduled for storage in the particular higher priority bin instead displaces a record in a lower priority bin.

14. A method according to claim 1, wherein the at least one electrode comprises at least one of:

a subcutaneous electrode, a transcutaneous electrode, an electrode coupled to a portion of the device.

15. A method according to claim 1, wherein the method is reset following occurrence of a signal saturation event.

16. An apparatus for detecting R-waves, comprising:

threshold setting means for providing at least two thresholds for a primary portion and a secondary portion of an ECG waveform, respectively;

comparing means for comparing the at least two thresholds to the primary and second portion of the ECG waveform;

logic means for determining whether each portion of the ECG waveform that exceeds a corresponding threshold is a native R-wave or is a spurious noise peak, a myopotential or other signal artifact and whether an arrhythmia or an asystole has occurred; and

storage means for storing portions of the ECG waveform for which an arrhythmia or an asystole is determined to have occurred wherein the storage means operates according to a priority sequence so that in the event that a limited storage event occurs, a lower priority ECG waveform is displaced by a higher priority ECG waveform.

17. An apparatus according to claim 16, wherein the apparatus is reset following occurrence of a signal saturation event.