Granted Patent B2

US 12,251,231 · App. 18/061,878 · Granted Mar 18, 2025

Inventors: Shantanu Sarkar (Roseville, MN); Daniel L. Hansen (Castle Rock, CO); Grant A. Neitzell (Plymouth, MN); Jerry D. Reiland (Coon Rapids, MN); Ryan D. Wyszynski (Oak Grove, MN)

Assignee: Medtronic, Inc.

A61B5/361A61B5/24A61B5/316A61B5/349A61B5/352A61B5/686A61N1/3624A61N1/36507A61N1/36592A61N1/395A61N1/3987A61B5/363

Abstract

Claims (112)

1. A medical device system comprising:

a medical device comprising two or more electrodes, wherein the medical device is configured to sense a cardiac signal via the two or more electrodes; and

processing circuitry configured to:

identify, based on the cardiac signal, a set of P-wave windows;

determine, based on the cardiac signal within each P-wave window of the set of P-wave windows, a characteristic signal;

process the characteristic signal to identify one or more signal characteristics;

determine, based on the one or more signal characteristics, whether the characteristic signal includes a P-wave;

determine, based on whether the characteristic signal includes a P-wave, whether an atrial arrhythmia is detected; and

generate for output, based on the characteristic signal including the P-wave, an indication that the atrial arrhythmia is detected.

2. The medical device system of claim 1 , wherein the processing circuitry is further configured to:

identify, in the cardiac signal, one or more pairs of consecutive R-waves;

determine, for each pair of consecutive R-waves of the one or more pairs of consecutive R-waves, whether an RR-interval corresponding to the respective pair of consecutive R-waves is greater than an RR-interval threshold; and

identify, for each pair of consecutive of R-waves having an RR-interval greater than the RR-interval threshold, a P-wave window of the set of P-wave windows.

3. The medical device system of claim 1 , wherein to determine the characteristic signal, the processing circuitry is configured to determine an average of the cardiac signal within the set of P-wave windows.

4. The medical device system of claim 1 , wherein the characteristic signal corresponds to a characteristic window, wherein the processing circuitry is further configured to:

determine a baseline portion of the characteristic window;

determine a P-wave portion of the characteristic window, wherein the baseline portion is prior to the P-wave portion, and

process a first portion of the characteristic signal within the baseline portion of the characteristic window and a second portion of the characteristic signal within the P-wave portion of the characteristic window to identify the one or more signal characteristics.

5. The medical device system of claim 4 , wherein the baseline portion of the characteristic window extends from a start of the characteristic window to a midpoint of the characteristic window, and wherein the P-wave portion of the characteristic window extends from the midpoint of the characteristic window to an endpoint of the characteristic window.

6. The medical device system of claim 4 , wherein to determine whether the characteristic signal includes a P-wave, the processing circuitry is configured to:

determine a second derivative of the characteristic signal corresponding to the P-wave portion of the characteristic window;

identify one or more maximum amplitudes in the second derivative of the characteristic signal corresponding to the P-wave portion of the characteristic window;

compare each maximum amplitude of the one or more maximum amplitudes to a first threshold;

identify one or more minimum amplitudes in the second derivative of the characteristic signal corresponding to the P-wave portion of the characteristic window;

compare each minimum amplitude of the one or more minimum amplitudes to a second threshold; and

determine that the characteristic signal does not include a P-wave when:

a number of the one or more maximum amplitudes greater than or equal to the first threshold is equal to one; or

a number of the one or more minimum amplitudes less than or equal to the second threshold is equal to one.

7. The medical device system of claim 6 , wherein the processing circuitry is configured to determine that the characteristic signal does not include a P-wave when:

the number of the one or more maximum amplitudes greater than or equal to the first threshold is not equal to one; and

the number of the one or more minimum amplitudes less than or equal to the second threshold is not equal to one.

8. The medical device system of claim 4 , wherein the processing circuitry is further configured to:

determine a first derivative of the characteristic signal corresponding to the characteristic window;

determine a second derivative of the characteristic signal corresponding to the characteristic window; and

determine, based on the first derivative of the characteristic signal and the second derivative of the characteristic signal, whether the characteristic signal corresponds to an atrial flutter event.

9. The medical device system of claim 8 , wherein the processing circuitry is configured to:

identify one or more maximum amplitudes of the second derivative of the characteristic signal within the baseline portion of the characteristic window, wherein each maximum amplitude of the one or more maximum amplitudes is associated with a respective positive going zero crossing of the first derivative of the characteristic signal;

determine whether each maximum amplitude of the one or more maximum amplitudes within the baseline portion is greater than a first threshold amplitude;

identify one or more minimum amplitudes of the second derivative of the characteristic signal within the baseline portion of the characteristic window, wherein each minimum amplitude of the one or more minimum amplitudes is associated with a respective negative going zero crossing of the first derivative of the characteristic signal;

determine whether each minimum amplitude of the one or more minimum amplitudes within the baseline portion is less than a second threshold amplitude;

identify one or more maximum amplitudes of the second derivative of the characteristic signal within the P-wave portion of the characteristic window, wherein each maximum amplitude of the one or more maximum amplitudes is associated with a respective positive going zero crossing of the first derivative of the characteristic signal;

determine whether each maximum amplitude of the one or more maximum amplitudes within the baseline portion is greater than the first threshold amplitude;

identify one or more minimum amplitudes of the second derivative of the characteristic signal within the P-wave portion of the characteristic window, wherein each minimum amplitude of the one or more minimum amplitudes is associated with a respective negative going zero crossing of the first derivative of the characteristic signal; and

determine whether each minimum amplitude of the one or more minimum amplitudes within the P-wave portion is less than the second threshold amplitude,

wherein to determine whether the characteristic signal corresponds to an atrial flutter event, the processing circuitry is configured to:

calculate a first sum of a number of the one or more maximum amplitudes within the baseline portion greater than the first threshold amplitude and a number of the one or more maximum amplitudes within the baseline portion greater than the second threshold amplitude;

calculate a second sum of a number of the one or more maximum amplitudes within the P-wave portion greater than the first threshold amplitude and a number of the one or more maximum amplitudes within the P-wave portion greater than the second threshold amplitude;

determine whether the first sum is equal to a first target number of amplitudes; and

determine whether an absolute value of a difference between the first sum and the second sum is less than or equal to a second target number of amplitudes.

10. The medical device system of claim 4 , wherein the processing circuitry is further configured to:

determine a first derivative of the characteristic signal corresponding to the characteristic window;

determine a second derivative of the characteristic signal corresponding to the characteristic window; and

determine, based on the first derivative of the characteristic signal and the second derivative of the characteristic signal, whether the characteristic signal corresponds to a noise event.

11. The medical device system of claim 10 , wherein the processing circuitry is configured to:

identify a maximum value of the second derivative of the characteristic signal within the baseline portion of the characteristic window; and

identify a minimum value of the second derivative of the characteristic signal within the baseline portion of the characteristic window,

wherein the processing circuitry is configured to determine, based on the maximum value and the minimum value, whether the characteristic signal corresponds to a noise event.

12. A method comprising:

sensing, by a medical device comprising two or more electrodes, a cardiac signal via the two or more electrodes;

identifying, by processing circuitry based on the cardiac signal, a set of P-wave windows;

determining, by the processing circuitry based on the cardiac signal within each P-wave window of the set of P-wave windows, a characteristic signal;

processing, by the processing circuitry, the characteristic signal to identify one or more signal characteristics;

determining, by the processing circuitry based on the one or more signal characteristics, whether the characteristic signal includes a P-wave;

determining, by the processing circuitry based on whether the characteristic signal includes a P-wave, whether an atrial arrhythmia is detected; and

generating, for output by the processing circuitry, based on the characteristic signal including the P-wave, an indication that the atrial arrhythmia is detected.

13. The method of claim 12 , wherein method further comprises:

identifying, by the processing circuitry in the cardiac signal, one or more pairs of consecutive R-waves;

determining, by the processing circuitry for each pair of consecutive R-waves of the one or more pairs of consecutive R-waves, whether an RR-interval corresponding to the respective pair of consecutive R-waves is greater than an RR-interval threshold; and

identifying, by the processing circuitry for each pair of consecutive of R-waves having an RR-interval greater than the RR-interval threshold, a P-wave window of the set of P-wave windows.

14. The method of claim 12 , wherein determining the characteristic signal comprises determining an average of the cardiac signal within the set of P-wave windows.

15. The method of claim 12 , wherein the characteristic signal corresponds to a characteristic window, and wherein method further comprises:

determining, by the processing circuitry, a baseline portion of the characteristic window;

determining, by the processing circuitry, a P-wave portion of the characteristic window, wherein the baseline portion is prior to the P-wave portion, and

processing, by the processing circuitry, a first portion of the characteristic signal within the baseline portion of the characteristic window and a second portion of the characteristic signal within the P-wave portion of the characteristic window to identify the one or more signal characteristics.

16. The method of claim 15 , wherein determining whether the characteristic signal includes a P-wave comprises:

determining a second derivative of the characteristic signal corresponding to the P-wave portion of the characteristic window;

identifying one or more maximum amplitudes in the second derivative of the characteristic signal corresponding to the P-wave portion of the characteristic window;

comparing each maximum amplitude of the one or more maximum amplitudes to a first threshold;

identifying one or more minimum amplitudes in the second derivative of the characteristic signal corresponding to the P-wave portion of the characteristic window;

comparing each minimum amplitude of the one or more minimum amplitudes to a second threshold; and

determining that the characteristic signal does not include a P-wave when:

a number of the one or more maximum amplitudes greater than or equal to the first threshold is equal to one; or

a number of the one or more minimum amplitudes less than or equal to the second threshold is equal to one.

17. The method of claim 16 , further comprising determining that the characteristic signal does not include a P-wave when:

the number of the one or more maximum amplitudes greater than or equal to the first threshold is not equal to one; and

the number of the one or more minimum amplitudes less than or equal to the second threshold is not equal to one.

18. The method of claim 15 , further comprising:

determining, by the processing circuitry, a first derivative of the characteristic signal corresponding to the characteristic window;

determining, by the processing circuitry, a second derivative of the characteristic signal corresponding to the characteristic window; and

determining, by the processing circuitry based on the first derivative of the characteristic signal and the second derivative of the characteristic signal, whether the characteristic signal corresponds to an atrial flutter event.

19. The method of claim 18 , further comprising:

identifying, by the processing circuitry, one or more maximum amplitudes of the second derivative of the characteristic signal within the baseline portion of the characteristic window, wherein each maximum amplitude of the one or more maximum amplitudes is associated with a respective positive going zero crossing of the first derivative of the characteristic signal;

determining, by the processing circuitry, whether each maximum amplitude of the one or more maximum amplitudes within the baseline portion is greater than a first threshold amplitude;

identifying, by the processing circuitry, one or more minimum amplitudes of the second derivative of the characteristic signal within the baseline portion of the characteristic window, wherein each minimum amplitude of the one or more minimum amplitudes is associated with a respective negative going zero crossing of the first derivative of the characteristic signal;

determining, by the processing circuitry, whether each minimum amplitude of the one or more minimum amplitudes within the baseline portion is less than a second threshold amplitude;

identifying, by the processing circuitry, one or more maximum amplitudes of the second derivative of the characteristic signal within the P-wave portion of the characteristic window, wherein each maximum amplitude of the one or more maximum amplitudes is associated with a respective positive going zero crossing of the first derivative of the characteristic signal;

determining, by the processing circuitry, whether each maximum amplitude of the one or more maximum amplitudes within the baseline portion is greater than the first threshold amplitude;

identifying, by the processing circuitry, one or more minimum amplitudes of the second derivative of the characteristic signal within the P-wave portion of the characteristic window, wherein each minimum amplitude of the one or more minimum amplitudes is associated with a respective negative going zero crossing of the first derivative of the characteristic signal; and

determining, by the processing circuitry, whether each minimum amplitude of the one or more minimum amplitudes within the P-wave portion is less than the second threshold amplitude,

wherein determining whether the characteristic signal corresponds to an atrial flutter event comprises:

calculating a first sum of a number of the one or more maximum amplitudes within the baseline portion greater than the first threshold amplitude and a number of the one or more maximum amplitudes within the baseline portion greater than the second threshold amplitude;

calculating a second sum of a number of the one or more maximum amplitudes within the P-wave portion greater than the first threshold amplitude and a number of the one or more maximum amplitudes within the P-wave portion greater than the second threshold amplitude;

determining whether the first sum is equal to a first target number of amplitudes; and

determining whether an absolute value of a difference between the first sum and the second sum is less than or equal to a second target number of amplitudes.

20. A computer-readable medium comprising instructions that, when executed by one or more processors, cause the one or more processors to:

sense, via two or more electrodes of a medical device, a cardiac signal;

identify, based on the cardiac signal, a set of P-wave windows;

determine, based on the cardiac signal within each P-wave window of the set of P-wave windows, a characteristic signal;

process the characteristic signal to identify one or more signal characteristics;

determine, based on the one or more signal characteristics, whether the characteristic signal includes a P-wave;

determine, based on whether the characteristic signal includes a P-wave, whether an atrial arrhythmia is detected; and

generate, for output, based on the characteristic signal including the P-wave, an indication that the atrial arrhythmia is detected.

Assignments (1)

Continuity (5)

References Cited (183)