Data manipulation following delivery of a cardiac stimulus in an implantable cardiac stimulus device

• US 8,494,630 B2
• Filed: 01/16/2009
• Issued: 07/23/2013
• Est. Priority Date: 01/18/2008
• Status: Active Grant

• Current Assignee: Cameron Health Inc (Boston Scientific Corporation)
• Original Assignee: Cameron Health Inc (Boston Scientific Corporation)
• Inventors: Palreddy, Surekha, Allavatam, Venugopal
• Primary Examiner(s): Holmes, Rex R
• Application Number:
  US12/355,552
• Publication Number:
  US 20090187227A1
• Time in Patent Office: 1,649 Days
• Field of Search: 607 4- 5, 607/9, 607/17, 600509-510, 600515-518
• US Class Current: 607/17
• CPC Class Codes: A61B 5/364 Detecting abnormal ECG interval, e.g. extrasystoles, ectopic heartbeats
• CPC Class Codes: A61N 1/0504 Subcutaneous electrodes
• CPC Class Codes: A61N 1/3704 Circuits specially adapted therefor, e.g. for sensitivity control
• CPC Class Codes: A61N 1/3756 Casings with electrodes thereon, e.g. leadless stimulators
• CPC Class Codes: A61N 1/3925 Monitoring; Protecting
• CPC Class Codes: A61N 1/3943 for threshold determination
• CPC Class Codes: A61N 1/3987 characterised by the timing or triggering of the shock

Abstract

Methods of cardiac rhythm analysis in an implantable cardiac stimulus device, and devices configured for such methods. In an illustrative embodiment, certain data relating to cardiac event rate or amplitude is modified following delivery of a cardiac stimulus. In another embodiment, cardiac rhythm analysis is performed using one of plural states, with the plural states using different criteria, such as a detection threshold, to detect cardiac events in a sensed signal. Following delivery of a cardiac stimulus, data is manipulated to force the analysis into one of the states, where stimulus is delivered, in the illustrative embodiment, only after a different state is invoked. Implantable devices incorporating operational circuitry for performing such methods are also included in other illustrative embodiments.

Claims

1. A method of cardiac signal analysis in an implantable cardiac stimulus device (ICSD) comprising:

sensing electrical cardiac signals captured from implanted electrodes to analyze the cardiac rhythm of a patient;

determining that the cardiac rhythm of the patient is malignant and indicates cardiac stimulus, including determining that the patient has a cardiac rate in an arrhythmic range predefined by the ICSD;

delivering an indicated cardiac stimulus to the patient; and

;

following the delivery of the cardiac stimulus;

forcing the ICSD to calculate a recorded cardiac rate in a non-arrhythmic range by modifying stored data related to the timing of cardiac events; and

using the modified stored data to determine parameters for further sensing of cardiac signals following the delivery of the cardiac stimulus.

2. The method of claim 1 wherein the stored data related to the timing of cardiac events includes stored representations of intervals between detected cardiac events and the step of modifying the stored data includes recording data to simulate representations of intervals.

3. The method of claim 1 wherein the non-arrhythmic range is about 40 to 150 beats-per-minute.

4. The method of claim 1 wherein the step of modifying stored data related to the timing of cardiac events includes simulating a recorded cardiac rate of about 100 beats-per-minute.

5. The method of claim 1 wherein the step of modifying stored data further includes modifying stored amplitude data relating to previously sensed signals.

6. The method of claim 5 wherein the ICSD is configured to use at least first and second detection threshold functions, by invoking the first detection threshold function when a non-arrhythmic rate is calculated, and invoking the second detection threshold function when an arrhythmic rate is calculated, such that the modification of stored data forces the ICSD to use the first detection threshold function in a time period following cardiac stimulus delivery.

7. The method of claim 1 wherein the ICSD is configured to use at least first and second analysis states and the sensing and determining steps are performed as part of a detection method in which:

a cardiac event rate is estimated;

the cardiac event rate is estimated by counting detected events, wherein a detected event is identified when the sensed cardiac signal exceeds a time-varying threshold;

the first analysis state uses a first time-varying detection threshold;

the second analysis state uses a second time-varying detection threshold having characteristics that differ from the first time-varying detection threshold; and

transitions between the first and second analysis states are performed in response to changes in cardiac event rate;

wherein the step of modifying stored data related to the timing of cardiac events forces the ICSD into the first analysis state, and the step of determining that the cardiac rhythm of the patient is malignant can only occur from the second analysis state.

8. The method of claim 7 wherein the first analysis state is used at relatively lower cardiac event rates and the second analysis state is used at relatively higher cardiac event rates;

the first time-varying detection threshold begins at a first value, decays to a second value until a timeout occurs, and then decays to a sensing floor; and

the second time-varying detection threshold begins at a third value and decays to the sensing floor.

9. The method of claim 1 further comprising using the modified stored data in making one or more determinations of whether an additional stimulus is needed.

10. The method of claim 1 further comprising, after the cardiac stimulus is delivered, using the parameters determined from the modified stored data to detect cardiac events and determine whether either:

the patient'"'"'s cardiac rhythm has returned to normal and no further stimulus is required;

or

additional cardiac stimulus should be delivered.

11. The method of claim 10 wherein the ICSD is configured to use at least a set of “

Slow Rate”

parameters for cardiac event sensing when a detected cardiac rate is below a Slow Rate threshold and a second set of “

Fast Rate”

parameters for cardiac event sensing when a detected cardiac rate is above a Fast Rate threshold, and the simulated recorded cardiac rate ensures use of the Slow Rate parameters following delivery of cardiac stimulus.

12. An implantable cardiac stimulus device (ICSD) comprising a plurality of electrodes for cardiac electrical sensing and/or therapy delivery;

operational circuitry coupled to the plurality of electrodes including therapy delivery circuitry for delivering electrical cardiac therapy via the electrodes and analysis circuitry for analyzing cardiac signals in conjunction with processing circuitry, wherein the operational circuitry is configured to perform cardiac signal analysis and treatment as follows;

sensing electrical cardiac signals captured from the electrodes to analyze the cardiac rhythm of a patient;

determining that the cardiac rhythm of the patient is malignant and indicates cardiac stimulus, including determining that the patient has a cardiac rate in an arrhythmic range predefined by the ICSD;

delivering an indicated cardiac stimulus to the patient via the electrodes; and

;

following the delivery of the cardiac stimulus;

forcing the ICSD to calculate a recorded cardiac rate in a non-arrhythmic range by modifying stored data related to the timing of cardiac events; and

using the modified stored data to determine parameters for further sensing of cardiac signals following the delivery of the cardiac stimulus.

13. The ICSD of claim 12 wherein the operational circuitry is further configured such that the stored data related to the timing of cardiac events includes stored representations of intervals between detected cardiac events and the step of modifying the stored data includes recording data to simulate representations of intervals.

14. The ICSD of claim 12 wherein the operational circuitry is further configured such that the non-arrhythmic range is about 40 to 150 beats-per-minute.

15. The ICSD of claim 12 wherein the operational circuitry is further configured to simulate a recorded cardiac rate of about 100 beats-per-minute.

16. The ICSD of claim 12 wherein the operational circuitry is further configured such that the step of modifying stored data further includes modifying stored amplitude data relating to previously sensed signals.

17. The ICSD of claim 16 wherein the ICSD is configured to use at least first and second detection threshold functions, by invoking the first detection threshold function when a non-arrhythmic rate is calculated, and invoking the second detection threshold function when an arrhythmic rate is calculated, such that the modification of stored data forces the ICSD to use the first detection threshold function in a time period following cardiac stimulus delivery.

18. The ICSD of claim 12 wherein the ICSD is configured to use at least first and second analysis states and the sensing and determining steps are performed as part of a detection method in which:

a cardiac event rate is estimated;

the cardiac event rate is estimated by counting detected events, wherein a detected event is identified when the sensed cardiac signal exceeds a time-varying threshold;

the first analysis state uses a first time-varying detection threshold;

the second analysis state uses a second time-varying detection threshold having characteristics that differ from the first time-varying detection threshold; and

transitions between the first and second analysis states are performed in response to changes in cardiac event rate;

wherein the step of modifying stored data related to the timing of cardiac events forces the ICSD into the first analysis state, and the step of determining that the cardiac rhythm of the patient is malignant can only occur from the second analysis state.

19. The ICSD of claim 18 wherein the operational circuitry is further configured such that the first analysis state is used at relatively lower cardiac event rates and the second analysis state is used at relatively higher cardiac event rates;

the first time-varying detection threshold begins at a first value, decays to a second value until a timeout occurs, and then decays to a sensing floor; and

the second time-varying detection threshold begins at a third value and decays to the sensing floor.

20. The ICSD of claim 12 wherein the operational circuitry is further comprised to use the parameters determined from the modified stored data to detect cardiac events following delivery of cardiac stimulus and determine whether either:

the patient'"'"'s cardiac rhythm has returned to normal and no further stimulus is required;

or

additional cardiac stimulus should be delivered.

21. The ICSD of claim 20 wherein the operational circuitry is further configured to use at least a set of “

Slow Rate”

parameters for cardiac event sensing when a detected cardiac rate is below a Slow Rate threshold and a second set of “

Fast Rate”

parameters for cardiac event sensing when a detected cardiac rate is above a Fast Rate threshold, and the simulated recorded cardiac rate ensures use of the Slow Rate parameters following delivery of cardiac stimulus.