Methods and devices for adapting charge initiation for an implantable defibrillator

• US 8,670,826 B2
• Filed: 08/30/2012
• Issued: 03/11/2014
• Est. Priority Date: 01/25/2005
• Status: Active Grant

• Current Assignee: Cameron Health Inc (Boston Scientific Corporation)
• Original Assignee: Cameron Health Inc (Boston Scientific Corporation)
• Inventors: Warren, Jay A., Bardy, Gust H.
• Primary Examiner(s): Koharski, Christopher D
• Assistant Examiner(s): OROPEZA, FRANCES P
• Application Number:
  US13/599,513
• Publication Number:
  US 20120323290A1
• Time in Patent Office: 558 Days
• Field of Search: 607/5, 607/14, 607/28
• US Class Current: 607/5
• CPC Class Codes: A61N 1/3621 for treating or preventing abnormally high heart rate
• CPC Class Codes: A61N 1/3943 for threshold determination
• CPC Class Codes: A61N 1/3956 Implantable devices for applying electric shocks to the heart, e.g. for cardioversion

Abstract

Adaptive methods for initiating charging of the high power capacitors of an implantable medical device for therapy delivery after the patient experiences a non-sustained arrhythmia, and devices that perform such methods. The adaptive methods and devices adjust persistence criteria used to analyze an arrhythmia prior to initiating a charging sequence to deliver therapy. Some embodiments apply a specific sequence of X-out-of-Y criteria, persistence criteria, and last event criteria before starting charging for therapy delivery.

Claims

1. An implantable cardiac stimulus device (ICSD) configured for implantation into a patient'"'"'s body comprising, a housing having at least one electrode and configured to receive a lead having a plurality of electrodes, operational circuitry contained in the housing and configured to receive signals from electrodes on the lead and/or housing when the lead is received by the housing wherein the operational circuitry is configured to perform a method of cardiac signal analysis comprising:

sensing signals from the electrodes;

identifying detected events in the sensed signals with the intent that detected events represent cardiac events;

determining whether a high-rate arrhythmia appears likely;

calculating an X/Y counter in which X represents the number of detected events identified as likely indicating a malignant cardiac rhythm out of a set of Y detected events; and

determining whether the X/Y counter indicates therapy for the patient;

wherein the operational circuitry is configured to allow at least first and second settings for the X/Y counter, in which the second setting uses values for X and Y that are greater than values for X and Y used in the first setting and greater than 18 for X and greater than 24 for Y;

wherein the operational circuitry is configured to identify nonsustained tachycardia in which the first setting of the X/Y counter is net and, in response to identification of nonsustained tachycardia, to adopt the use of the second setting for the X/Y counter in analyzing future cardiac rhythms to avoid unnecessary therapy delivery.

2. The ICSD of claim 1 wherein the first setting for the X/Y counter uses X=18 and Y=24.

3. The ICSD of claim 1 wherein the operational circuitry is further configured to perform the following:

in response to determining that the X/Y counter does indicate therapy for the patient, determining whether a persistence factor is also met by determining whether the X/Y counter is met at least N times, wherein N is a predetermined quantity of at least 2.

4. The ICSD of claim 3 wherein N is configurable to have values of at least 2 and 5, wherein N is set equal to 2 by default and is increased to 5 in response to an identified nonsustained tachycardia.

5. The ICSD of claim 1 wherein the housing and lead are both configured for subcutaneous-only placement in the patient.

6. The ICSD of claim 1 wherein the housing and lead are configured for implantation in a patient as a transvenous ICD system.

7. An implantable cardiac stimulus device (ICSD) configured for implantation into a patient'"'"'s body comprising, a housing having one or more electrodes and configured to receive a lead having a plurality of electrodes, operational circuitry contained in the housing configured to receive signals from the electrodes on the lead and/or housing when the lead is received by the housing, wherein the operational circuitry is configured to perform a method of cardiac signal analysis comprising:

sensing signals from the electrodes;

identifying detected events in the sensed signals with the intent that detected events represent cardiac events;

determining whether a high-rate arrhythmia appears likely;

calculating an X/Y counter in which X represents the number of detected events identified as likely indicating a malignant cardiac rhythm out of a set of Y detected events, wherein the operational circuitry is configured to allow at least first and second settings for the X/Y counter, wherein the second setting uses values for X and Y that are greater than values for X and Y used in the first setting including a value greater than 18 for X and a value greater than 24 for Y;

determining that the X/Y counter indicates therapy for the patient and, if so, initiating a capacitor charging operation to prepare for therapy delivery; and

after the capacitor charging operation has been initiated but before therapy delivery, determining that a malignant cardiac rhythm is not occurring and, in response, ceasing charging and allowing capacitor charge to bleed and configuring the X/Y counter to use the second setting and not the first setting.

8. The ICSD of claim 7 wherein the first setting for the X/Y counter uses X=18 and Y=24.

9. The ICSD of claim 7 wherein the operational circuitry is further configured to perform the following:

in response to determining that the X/Y counter does indicate therapy for the patient, determining whether a persistence factor is also met by determining whether the X/Y counter is met at least N times, wherein N is a predetermined quantity of at least 2.

10. The ICSD of claim 9 wherein N is configurable to have values of at least 2 and 5, wherein N is set equal to 2 by default and is increased to 5 in response to an identified nonsustained tachycardia.

11. The ICSD of claim 7 wherein t housing and lead are both configured for subcutaneous-only placement in the patient.

12. The ICSD of claim 7 wherein the housing and lead are configured for implantation in a patient as a transvenous ICD system.

13. A method of operation in an implantable cardiac stimulus device (ICSD) configured for implantation into a patient'"'"'s body comprising a housing having one or more electrodes and configured to receive a lead having a plurality of electrodes, operational circuitry contained in the housing and configured to receive signals from the electrodes on the housing and/or lead when the lead is attached to the housing, the method comprising:

sensing signals from the electrodes;

identifying detected events in the sensed signals with the intent that detected events represent cardiac events;

determining whether a high-rate arrhythmia appears likely;

calculating an X/Y counter in which X represents the number of detected events identified as likely indicating a malignant cardiac rhythm out of a set of Y detected events, wherein the operational circuitry is configured to allow at least first and second settings for the X/Y counter, wherein the second setting uses values for X and Y that are greater than values for X and Y used in the first setting including a value greater than 18 for X and a value greater than 24 for Y;

determining that the X/Y counter indicates therapy for the patient and, if so, initiating a capacitor charging operation to prepare for therapy delivery; and

after the capacitor charging operation has been initiated but before therapy delivery, determining that a malignant cardiac rhythm is not occurring and, in response, ceasing charging and allowing capacitor charge to bleed and configuring the X/Y counter to use the second setting and not the first setting.

14. The method of claim 13 wherein the first setting for the X/Y counter uses X=18 and Y=24.

15. The method of claim 13, further comprising, in response to determining that the X/Y counter indicates therapy for the patient, determining whether a persistence factor is also met by determining whether the X/Y counter is met at least N times, wherein N is a predetermined quantity of at least 2.

16. The method of claim 15 wherein N is configurable to have values of at least 2 and 5, wherein N is set equal to 2 by default and is increased to 5 in response to an identified nonsustained tachycardia.

17. The method of claim 13 wherein the housing and lead are both configured for subcutaneous-only placement in the patient.

18. The method of claim 13 wherein the housing and lead are configured for implantation in a patient as a transvenous ICD system.

19. An implantable cardiac stimulus device configured for implantation into a patient'"'"'s body comprising a housing configured for implantation and configured to receive a lead having one or more electrodes, operational circuitry contained in the housing and configured to couple to the electrodes of the lead when the lead is received by the housing wherein the operational circuitry is configured to:

receive cardiac signals from the electrodes;

detect events in the cardiac signals;

establish an X out of Y calculation from the received cardiac signals, in which X represents a quantity of detected events from the received cardiac signals which appear to indicate a need for therapy to address a malignant condition;

monitor the X out of Y calculation by comparison to a predetermined threshold and, if the X out of Y calculation exceeds the predetermined threshold, to declare a treatable arrhythmia is occurring; and

upon declaration of a treatable arrhythmia, prepare for therapy delivery and analyze data to determine whether a nonsustained tachycardia can be identified and if so, the operational circuitry is configured to prevent therapy from being delivered to the identified nonsustained tachycardia;

wherein the operational circuitry is further configured to set the predetermined threshold such that X=18 and Y=24 and to increase both X and Y to reduce the likelihood of subsequent declarations of treatable arrhythmia in response to nonsustained tachycardias occurring with X=18 and Y=24.

20. A method of operation for an implantable cardiac stimulus device (ICSD) configured for implantation into a patient'"'"'s body, the ICSD comprising a housing configured for implantation and configured to receive a lead having a plurality of electrodes, operational circuitry contained in the housing and configured to sense signals from electrodes on the lead when the lead is received by the housing, wherein the method comprises:

the ICSD setting an initial X/Y threshold;

the ICSD sensing signals from the electrodes;

the ICSD detecting events in the sensed signals;

the ICSD establishing an X out of Y calculation from the received signals, in which X represents a quantity of detected events from the received signals which appear to indicate a need for therapy to address a malignant condition;

the ICSD monitoring the X out of Y calculation by comparison to the X/Y threshold;

the ICSD determining that the X out of Y calculation exceeds the X/Y threshold and declaring that a treatable arrhythmia is occurring;

upon declaration of a treatable arrhythmia, the ICSD preparing for therapy delivery and analyzing data to determine whether a nonsustained condition can be identified;

the ICSD determining that a nonsustained condition is occurring and withholding therapy from the patient; and

the ICSD, in response to nonsustained tachycardia, increasing both X and Y to set the X/Y threshold to reduce a future likelihood of declaration of treatable arrhythmia in the presence of a nonsustained condition by increasing X to a value greater than 18 and Y to a value greater than 24.

21. The method of claim 20 wherein at least one of the electrodes is on the housing.

22. The method of claim 20 wherein the ICSD includes a lead coupled to the housing with at least one electrode on the lead, further wherein the lead is configured for transvenous implantation, making the ICSD a transvenous system.

23. The method of claim 20 wherein the ICSD includes a lead coupled to the housing with at least one electrode on the lead, further wherein the lead is configured for subcutaneous implantation, making the ICSD a subcutaneous-only device.