Systems and methods for off-line reprogramming of implantable medical device components to reduce false detections of cardiac events

• US 9,078,574 B2
• Filed: 12/20/2013
• Issued: 07/14/2015
• Est. Priority Date: 11/06/2009
• Status: Active Grant

• Current Assignee: Pacesetter Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Pacesetter Incorporated (Abbott Laboratories Incorporated)
• Inventors: Snell, Jeffery D., Park, Euljoon
• Primary Examiner(s): Voorhees, Catherine
• Assistant Examiner(s): Dinga, Roland
• Application Number:
  US14/137,308
• Publication Number:
  US 20140114203A1
• Time in Patent Office: 571 Days
• Field of Search: 607/6, 607/27
• US Class Current: 1/1
• CPC Class Codes: A61B 2560/0271 using a remote monitoring unit
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• 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: A61N 1/3702 Physiological parameters A61N1/365 takes precedence; evoked response A61N1/371
• CPC Class Codes: A61N 1/37235 Aspects of the external programmer

Abstract

Techniques are provided for use by implantable medical devices such as pacemakers or by external systems in communication with such devices. An intracardiac electrogram (IEGM) is sensed within a patient in which the device is implanted using a cardiac signal sensing system. Cardiac events of interest such as arrhythmias, premature atrial contractions (PACs), premature ventricular contractions (PVCs) and pacemaker mediated tachycardias (PMTs) are detected within the patient using event detection systems and then portions of the IEGM representative of the events of interest are recorded in device memory. Subsequently, during an off-line or background analysis, the recorded IEGM data is retrieved and analyzed to identify false detections. In response to false detections, the cardiac signal sensing systems and/or the event detection systems of the implantable device are selectively adjusted or reprogrammed to reduce or eliminate any further false detections, including false-positives or false-negatives. Various adaptive reprogramming techniques are described.

Claims

1. A method for use with an implantable medical device, the method comprising:

sensing a cardiac signal within a patient in which the implantable medical device is implanted using a cardiac signal sensing system of the implantable medical device;

detecting cardiac events of interest within the patient using an event detection system of the implantable medical device;

recording portions of the cardiac signal, including portions representative of the events of interest;

detecting a stable cardiac state of the patient by the implantable medical device;

in response to detecting the stable cardiac state, initiating an off-line analysis of the recorded portions of the cardiac signal including portions representative of events of interest to identify false detections of events of interest, wherein the off-line analysis is performed by the implantable medical device concurrently with continued operation of the event detection system; and

selectively adjusting one or both of the cardiac signal sensing system and the event detection system to reduce false detections of events of interest identified by the off-line analysis.

2. The method of claim 1 wherein the events of interest are abnormal cardiac events.

3. The method of claim 2 wherein the abnormal cardiac events include one or more of:

arrhythmia events, premature atrial contraction (PAC) events, premature ventricular contraction (PVC) events, pacemaker mediated tachycardia (PMT) events and automatic mode switching (AMS) events.

4. The method of claim 1 wherein the false detections include one or both of false-positive detections and false-negative detections.

5. The method of claim 1 wherein detecting cardiac events of interest within the patient using the event detection system is performed substantially in real-time.

6. The method of claim 1 wherein retrieving and analyzing the portions of the cardiac signal to identify false detections of events of interest includes:

analyzing patient cardiac signals using an alternative event detection system that is less discriminating so as to identify possible false-negative detections.

7. The method of claim 1 wherein retrieving and analyzing the portions of the cardiac signal to identify false detections of events includes:

detecting the relative timing of event detections and exploiting the relative timing to distinguish between false detections and true detections.

8. The method of claim 1 wherein the event detection system exploits at least one adjustable detection parameter and wherein the detection parameter is adjusted to reduce false detections.

9. The method of claim 1 wherein the false detection is a false-negative detection and wherein the detection parameter is adjusted to expand a range of event detection to thereby reduce false-negative detections.

10. The method of claim 1 wherein the false detection is a false-positive detection and wherein the detection parameter is adjusted to reduce a range of event detection to thereby reduce false-positive detections.

11. The method of claim 1 wherein the cardiac signal sensing system exploits at least one sensitivity parameter and wherein the sensitivity parameter is adjusted to improve event detection by improving the sensing of cardiac signals used to detect events of interest.

12. The method of claim 1 wherein selectively adjusting the abnormal event detection system to reduce false detections of events of interest includes:

repeatedly reapplying the recorded cardiac signal data from the patient to an off-line event detection system along with an indication of false event detections while adjusting parameters employed by the off-line detection system so as to determine a set of detection parameters sufficient to reduce false detections.

13. The method of claim 1 wherein selectively adjusting the event detection system to reduce false detections of events of interest includes controlling a rate at which parameters employed by the detection system are iteratively adjusted.

14. The method of claim 1 wherein selectively adjusting the event detection system to reduce false detections of events of interest includes controlling a maximum range through which parameters employed by the detection system are adjusted.

15. The method of claim 1 wherein selectively adjusting the event detection system to reduce false detections of events of interest includes employing a history of prior adjustments to control subsequent adjustments.

16. The method of claim 1 wherein, upon detecting an inherent limitation in the event detection system, the device selectively adjusts a degree of bias between false-positive and false-negative events.

17. The method of claim 16 wherein, upon detecting an inherent limitation in the event detection system, the device generates a warning.

18. The method of claim 16 wherein, upon detecting an inherent limitation in the event detection system, the device reverts to a previous parameter setting.

19. The method of claim 16 wherein, upon detecting an inherent limitation in the event detection system, the device evaluates the severity of events of interest and selectively inhibits the recording of cardiac signal data based on severity.

20. The method of claim 1 further comprising:

detecting whether a sufficient amount of available processor capacity is available to perform the off-line analysis.