Method and apparatus for atrial arrhythmia episode detection

• US 9,603,543 B2
• Filed: 04/24/2015
• Issued: 03/28/2017
• Est. Priority Date: 02/18/2015
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Reiland, Jerry D, Sarkar, Shantanu, Hansen, Daniel L, Neitzell, Grant A, Wyszynski, Ryan
• Primary Examiner(s): DIETRICH, JOSEPH M
• Application Number:
  US14/695,111
• Publication Number:
  US 20160235992A1
• Time in Patent Office: 704 Days
• US Class Current: 1/1
• CPC Class Codes: A61B 5/24 Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
• CPC Class Codes: A61B 5/316 Modalities, i.e. specific diagnostic methods
• CPC Class Codes: A61B 5/349 Detecting specific parameters of the electrocardiograph cycle
• CPC Class Codes: A61B 5/352 Detecting R peaks, e.g. for synchronising diagnostic apparatus; Estimating R-R interval
• CPC Class Codes: A61B 5/361 Detecting fibrillation
• CPC Class Codes: A61B 5/363 Detecting tachycardia or bradycardia
• CPC Class Codes: A61B 5/686 Permanently implanted devices, e.g. pacemakers, other stimulators, biochips A61B5/6861 takes precedence
• CPC Class Codes: A61N 1/3624 occurring in the atrium, i.e. atrial tachycardia
• CPC Class Codes: A61N 1/36507 controlled by gradient or slope of the heart potential
• CPC Class Codes: A61N 1/36592 controlled by the heart rate variability
• CPC Class Codes: A61N 1/395 for treating atrial fibrillation
• CPC Class Codes: A61N 1/3987 characterised by the timing or triggering of the shock

Abstract

A method and implantable medical device for determining an atrial arrhythmia event that includes sensing a cardiac signal, determining an atrial arrhythmia score for identifying the arrhythmia event in response to the sensed cardiac signal, determining a sensing window in response to the sensed cardiac signal, the sensing window having a first portion and a second portion, determining signal characteristics of the sensed cardiac signal within the first portion and within the second portion, determining whether the sensed cardiac signal within the first portion and within the second portion corresponds to a P-wave in response to the determined signal characteristics, determining whether a signal to noise ratio of the sensed cardiac signal within the first portion and the second portion of the sensing window is satisfied, determining whether to update the arrhythmia score in response to the determined P-wave and the determined signal to noise ratio, and determining whether to delivery an arrhythmia therapy in response to the updated arrhythmia score.

Claims

1. A method of determining an atrial arrhythmia event in an implantable medical device, comprising:

sensing a cardiac signal;

determining an atrial arrhythmia score for identifying the arrhythmia event in response to the sensed cardiac signal;

determining a sensing window in response to the sensed cardiac signal, the sensing window having a first portion and a second portion;

determining a second derivative signal of the sensed cardiac signal within the first portion and the second portion of the sensing window;

determining signal characteristics of the sensed cardiac signal within the first portion and within the second portion;

determining whether the sensed cardiac signal within the first portion and within the second portion corresponds to a P-wave in response to the determined signal characteristics;

determining whether a signal to noise ratio of the sensed cardiac signal within the first portion and the second portion of the sensing window is satisfied based on amplitudes of the second derivative signal;

determining whether to update the arrhythmia score in response to the determined P-wave and the determined signal to noise ratio; and

determining whether to deliver an arrhythmia therapy in response to the updated arrhythmia score.

2. The method of claim 1, wherein determining whether the signal to noise ratio of the sensed cardiac signal within the first portion and the second portion of the sensing window is satisfied based on amplitudes of the second derivative signal comprises:

determining a first maximum amplitude of the second derivative signal within the first portion and a second maximum amplitude of the second derivative signal within the second portion of the sensing window;

comparing the first maximum amplitude with the second maximum amplitude; and

determining whether the signal to noise ratio is satisfied in response to the comparing.

3. The method of claim 2, wherein determining whether the signal to noise ratio is satisfied in response to the comparing comprises determining that the signal to noise ratio is satisfied when the second maximum amplitude is greater than the first maximum amplitude by a predetermined amplitude variation threshold.

4. The method of claim 3, wherein determining whether the signal to noise ratio is satisfied in response to the comparing comprises determining that the signal to noise ratio is satisfied when the second minimum amplitude is less than the first minimum amplitude by a predetermined amplitude variation threshold.

5. The method of claim 3, wherein the amplitude variation threshold is greater than four times the maximum amplitude of the second derivative signal within the first portion of the sensing window.

6. The method of claim 1, wherein determining whether the signal to noise ratio of the sensed cardiac signal within the first portion and the second portion of the sensing window is satisfied based on amplitudes of the second derivative signal comprises:

determining a first minimum amplitude of the second derivative signal within the first portion and a second minimum amplitude of the second derivative signal within the second portion of the sensing window;

comparing the first minimum amplitude with the second minimum amplitude; and

determining whether the signal to noise ratio is satisfied in response to the comparing.

7. The method of claim 1, wherein determining whether the signal to noise ratio of the sensed cardiac signal within the first portion and the second portion of the sensing window is satisfied based on amplitudes of the second derivative signal comprises:

determining a first maximum amplitude of the second derivative signal within the first portion and a second maximum amplitude of the second derivative signal within the second portion of the sensing window;

determining a first minimum amplitude of the second derivative signal within the first portion and a second minimum amplitude of the second derivative signal within the second portion of the sensing window;

comparing the first maximum amplitude with the second maximum amplitude and the first minimum amplitude with the second minimum amplitude; and

determining that the signal to noise ratio is satisfied in response to one of the second maximum amplitude being greater than the first maximum amplitude by a predetermined amplitude variation threshold or the second minimum amplitude being less than the first minimum amplitude by the amplitude variation threshold.

8. The method of claim 1, further comprising determining, in response to the signal to noise ratio not being satisfied, whether the sensed cardiac signal within the first portion and within the second portion of the sensing window corresponds to one of a flutter event and a noise event.

9. The method of claim 8, further comprising updating the arrhythmia score in response to the sensed cardiac signal within the first portion and within the second portion of the sensing window not corresponding to one of a flutter event and a noise event and the signal to noise ratio not being satisfied.

10. The method of claim 1, wherein the atrial arrhythmia event comprises one of an atrial tachycardia event and an atrial fibrillation event, the method further comprising increasing, in response to the sensed cardiac signal within the first portion and within the second portion corresponding to a P-wave, a P-wave evidence counter for atrial fibrillation by a first predetermined amount and increasing a P-wave evidence counter for atrial tachycardia by a second predetermined amount not equal to the first predetermined amount.

11. The method of claim 10, wherein the medical device comprises a subcutaneous device.

12. An implantable medical device for determining an atrial arrhythmia event, comprising:

a plurality of electrodes sensing the cardiac signal; and

a processor configured to determine an atrial arrhythmia score for identifying the arrhythmia event in response to the sensed cardiac signal, determine a sensing window in response to the sensed cardiac signal, the sensing window having a first portion and a second portion, determine a second derivative signal of the sensed cardiac signal within the first portion and the second portion of the sensing window, determine signal characteristics of the sensed cardiac signal within the first portion and within the second portion, determine whether the sensed cardiac signal within the first portion and within the second portion corresponds to a P-wave in response to the determined signal characteristics, determine whether a signal to noise ratio of the sensed cardiac signal within the first portion and the second portion of the sensing window is satisfied based on amplitudes of the second derivative signal, determine whether to update the arrhythmia score in response to the determined P-wave and the determined signal to noise ratio, and determine whether to deliver an arrhythmia therapy in response to the updated arrhythmia score.

13. The medical device of claim 12, wherein the processor is further configured to determine a first maximum amplitude of the second derivative signal within the first portion and a second maximum amplitude of the second derivative signal within the second portion of the sensing window, compare the first maximum amplitude with the second maximum amplitude, and determine whether the signal to noise ratio is satisfied in response to the comparing.

14. The medical device of claim 13, wherein the processor is configured to determine that the signal to noise ratio is satisfied when the second maximum amplitude is greater than the first maximum amplitude by a predetermined amplitude variation threshold.

15. The medical device of claim 12, wherein the processor is further configured to determine a first minimum amplitude of the second derivative signal within the first portion and a second minimum amplitude of the second derivative signal within the second portion of the sensing window, compare the first minimum amplitude with the second minimum amplitude, determine whether the signal to noise ratio is satisfied in response to the comparing.

16. The medical device of claim 15, wherein the processor is configured to determine that the signal to noise ratio is satisfied when the second minimum amplitude is less than the first minimum amplitude by a predetermined amplitude variation threshold.

17. The medical device of claim 12, wherein the processor is further configured to determine a first maximum amplitude of the second derivative signal within the first portion and a second maximum amplitude of the second derivative signal within the second portion of the sensing window, determine a first minimum amplitude of the second derivative signal within the first portion and a second minimum amplitude of the second derivative signal within the second portion of the sensing window, compare the first maximum amplitude with the second maximum amplitude and the first minimum amplitude with the second minimum amplitude, and determine that the signal to noise ratio is satisfied in response to one of the second maximum amplitude being greater than the first maximum amplitude by a predetermined amplitude variation threshold or the second minimum amplitude being less than the first minimum amplitude by the amplitude variation threshold.

18. An implantable medical device for determining an atrial arrhythmia event, comprising:

a plurality of electrodes sensing the cardiac signal; and

a processor configured to determine an atrial arrhythmia score for identifying the arrhythmia event in response to the sensed cardiac signal, determine a sensing window in response to the sensed cardiac signal, the sensing window having a first portion and a second portion, determine signal characteristics of the sensed cardiac signal within the first portion and within the second portion, determine whether the sensed cardiac signal within the first portion and within the second portion corresponds to a P-wave in response to the determined signal characteristics, determine whether a signal to noise ratio of the sensed cardiac signal within the first portion and the second portion of the sensing window is satisfied, determine whether to update the arrhythmia score in response to the determined P-wave and the determined signal to noise ratio, and determine whether to deliver an arrhythmia therapy in response to the updated arrhythmia score, wherein the processor is further configured to determine, in response to the signal to noise ratio not being satisfied, whether the sensed cardiac signal within the first portion and within the second portion of the sensing window corresponds to one of a flutter event and a noise event.

19. The medical device of claim 18, wherein the processor is further configured to update updating the arrhythmia score in response to the sensed cardiac signal within the first portion and within the second portion of the sensing window not corresponding to one of a flutter event and a noise event and the signal to noise ratio not being satisfied.

20. An implantable medical device for determining an atrial arrhythmia event, comprising:

a plurality of electrodes sensing the cardiac signal; and

a processor configured to determine an atrial arrhythmia score for identifying the arrhythmia event in response to the sensed cardiac signal, determine a sensing window in response to the sensed cardiac signal, the sensing window having a first portion and a second portion, determine signal characteristics of the sensed cardiac signal within the first portion and within the second portion, determine whether the sensed cardiac signal within the first portion and within the second portion corresponds to a P-wave in response to the determined signal characteristics, determine whether a signal to noise ratio of the sensed cardiac signal within the first portion and the second portion of the sensing window is satisfied, determine whether to update the arrhythmia score in response to the determined P-wave and the determined signal to noise ratio, and determine whether to deliver an arrhythmia therapy in response to the updated arrhythmia score, wherein the atrial arrhythmia event comprises one of an atrial tachycardia event and an atrial fibrillation event, the processor further configured to increase, in response to the sensed cardiac signal within the first portion and within the second portion corresponding to a P-wave, a P-wave evidence counter for atrial fibrillation by a first predetermined amount and increasing a P-wave evidence counter for atrial tachycardia by a second predetermined amount not equal to the first predetermined amount.

21. The medical device of claim 20, wherein the medical device comprises a subcutaneous device.

22. A non-transitory computer-readable medium storing a set of instructions which cause a processor of an implantable medical device to perform a method of determining an atrial arrhythmia event, comprising:

sensing a cardiac signal;

determining an atrial arrhythmia score for identifying the arrhythmia event in response to the sensed cardiac signal;

determining a sensing window in response to the sensed cardiac signal, the sensing window having a first portion and a second portion;

determining a second derivative signal of the sensed cardiac signal within the first portion and the second portion of the sensing window;

determining signal characteristics of the sensed cardiac signal within the first portion and within the second portion;

determining whether the sensed cardiac signal within the first portion and within the second portion corresponds to a P-wave in response to the determined signal characteristics;

determining whether a signal to noise ratio of the sensed cardiac signal within the first portion and the second portion of the sensing window is satisfied based on amplitudes of the second derivative signal;

determining whether to update the arrhythmia score in response to the determined P-wave and the determined signal to noise ratio; and

determining whether to deliver an arrhythmia therapy in response to the updated arrhythmia score.