Algorithm adaptation to an external impact on the data

• US 9,643,012 B2
• Filed: 02/11/2014
• Issued: 05/09/2017
• Est. Priority Date: 02/18/2013
• Status: Active Grant

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Averina, Viktoria A., Thakur, Pramodsingh Hirasingh, Zhang, Yi, An, Qi
• Primary Examiner(s): Evansiko, George
• Application Number:
  US14/178,078
• Publication Number:
  US 20140236029A1
• Time in Patent Office: 1,183 Days
• CPC Class Codes: A61B 2560/0276 Determining malfunction
• CPC Class Codes: A61B 5/02055 Simultaneously evaluating both cardiovascular condition and temperature
• CPC Class Codes: A61B 5/349 Detecting specific parameters of the electrocardiograph cycle
• CPC Class Codes: A61B 5/4839 combined with drug delivery
• CPC Class Codes: A61B 5/686 Permanently implanted devices, e.g. pacemakers, other stimulators, biochips A61B5/6861 takes precedence
• CPC Class Codes: A61B 5/7221 Determining signal validity, reliability or quality A61B5/7207 and A61B5/7217 take precedence
• CPC Class Codes: A61B 5/7278 Artificial waveform generation or derivation, e.g. synthesising signals from measured signals A61B5/327 takes precedence
• CPC Class Codes: A61N 1/3627 for treating a mechanical deficiency of the heart, e.g. congestive heart failure or cardiomyopathy

Abstract

Devices and methods for detecting a physiological target event such as events indicative of HF decompensation status are described. An ambulatory medical device is configured to determine the presence and timing of a confounding event, segment a sensed physiological signal into at least two data segments, adjust the physiological signal by removing or lessening the impact of the confounding event on the physiological signal. The adjusted data can be presented to the user, and the ambulatory medical device can detect the target events using the adjusted physiologic signal. In some embodiments, the ambulatory medical device can be configured to detect an event indicative of HF decompensation using a physiological signal and the information of the detected confounding event.

Claims

1. An ambulatory medical device, comprising:

a signal receiver circuit, configured to receive a physiologic signal, for detecting a physiologic target event or condition of a patient;

a confounding event detection and analysis circuit, including a confounding event-bearing (CEB) signal receiver circuit configured to receive at least one CEB signal, and a confounding event detector configured to detect the presence of a confounding event from the at least one CEB signal, different from the physiologic target event or condition;

a signal processing circuit, configured to

segment the physiologic signal into at least first and second segments based on a detected start time of the confounding event, the first segment exhibiting a different steady-state signal level than the second segment, and

adjust at least one of the first or second segments;

wherein adjusting at least one of the first or second segments of a physiologic signal includes computing and using the difference between the at least one of the first or second segments and a reference signal over a specified time period relative to a start time of the confounding event;

a target event or condition detector circuit, configured to detect the physiologic target event or condition from the at least one of the first or second adjusted segments of the physiologic signal;

wherein the confounding event detection and analysis circuit is further configured to

determine the presence of the confounding event according to whether or not the at least one CEB signal meets at least one physiologically relevant criterion comprising a range of values having physiological relevance to the target event, and

indicate the presence of a confounding event if the CEB signal falls outside of the range of values having physiological relevance to the target event.

2. The device of claim 1, wherein the signal receiver circuit is configured to be coupled to at least one of a signal memory or a signal sensing circuit, and wherein the signal sensing circuit is configured to sense the physiologic signal.

3. The device of claim 1, wherein the confounding event detector is configured to detect, from the at least one CEB signal, an event indicative of at least one of a change of integrity of the device, a change of configuration of the device, a change of interaction between the device and the patient, a change of patient environment, a change of the patient condition, a replacement of the device, and a medical event.

4. The device of claim 1, the confounding event detection and analysis circuit further including a confounding event characterizer configured to compute characteristic parameters of the detected confounding event;

wherein segmenting the physiologic signal into at least the first and second segments by the signal processing circuit further includes using at least one characteristic parameter of the detected confounding event, the characteristic parameter selected from the group consisting of a stop time, a duration, and a type of the detected confounding event; and

adjusting the at least one of the first and second segments by the signal processing circuit further includes using a comparison between a first metric determined from the first segment and a second metric determined from the second segment.

5. The device of claim 1, wherein the signal processing circuit is configured to determine a mode of adjustment using at least one of a type of the detected confounding event, and a type of the physiologic signal, and wherein the mode of adjustment is selected from a transient adjustment and a permanent adjustment.

6. The ambulatory medical device of claim 1, wherein the confounding event detection and analysis circuit is further configured to include the range of values having physiological relevance to the target that are determined using population data or the patient'"'"'s historical data.

7. The ambulatory medical device of claim 1, wherein the physiologic signal received by the signal receiver circuit includes intrathoracic impedance;

and

wherein the at least one physiologically relevant criterion comprises a change of intrathoracic impedance of less than 50 ohms.

8. The ambulatory medical device of claim 1, wherein the physiologic signal received by the signal receiver circuit includes intrathoracic impedance;

and

wherein the at least one physiologically relevant criterion comprises a rate of change in impedance less than 5 ohm/day or 10% of a baseline impedance value per day.

9. The ambulatory medical device of claim 1, wherein the reference signal is a moving average of the physiological data over a specified time period.