Cardiac resynchronization using fusion promotion for timing management

• US 10,870,008 B2
• Filed: 08/23/2017
• Issued: 12/22/2020
• Est. Priority Date: 08/24/2016
• Status: Active Grant

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Hahn, Stephen J., Stein, Kenneth M., Yu, Yinghong, Healy, Scott J., Morgan, John
• Primary Examiner(s): Wehrheim, Lindsey G
• Application Number:
  US15/684,264
• Publication Number:
  US 20180056079A1
• Time in Patent Office: 1,217 Days
• CPC Class Codes: A61B 5/35 by template matching
• CPC Class Codes: A61B 5/352 Detecting R peaks, e.g. for synchronising diagnostic apparatus; Estimating R-R interval
• CPC Class Codes: A61N 1/3627 for treating a mechanical deficiency of the heart, e.g. congestive heart failure or cardiomyopathy
• CPC Class Codes: A61N 1/36592 controlled by the heart rate variability
• CPC Class Codes: A61N 1/3682 with a variable atrioventricular delay
• CPC Class Codes: A61N 1/36843 Bi-ventricular stimulation
• CPC Class Codes: A61N 1/37252 Details of algorithms or data aspects of communication system, e.g. handshaking, transmitting specific data or segmenting data
• CPC Class Codes: A61N 1/37288 Communication to several implantable medical devices within one patient
• CPC Class Codes: A61N 1/37512 Pacemakers
• CPC Class Codes: A61N 1/3756 Casings with electrodes thereon, e.g. leadless stimulators
• CPC Class Codes: A61N 1/378 Electrical supply
• CPC Class Codes: A61N 1/3918 characterised by shock pathway, e.g. by electrode configuration
• CPC Class Codes: A61N 1/3962 in combination with another heart therapy
• CPC Class Codes: A61N 1/39622 Pacing therapy

Abstract

Methods, systems and devices for providing cardiac resynchronization therapy (CRT) to a patient using a leadless cardiac pacemaker and an extracardiac device. The extracardiac device is configured to analyze one or more QRS complexes of the patient'"'"'s heart, determine whether fusion pacing is taking place, and, if not, to communicate with the leadless cardiac pacemaker to adjust intervals used in the CRT in order to generate desirable fusion of the pace and intrinsic signals. The extracardiac device may take the form of a subcutaneous implantable monitor, a subcutaneous implantable defibrillator, or other devices including wearable devices.

Claims

1. An implantable medical device (IMD) configured for use as part of a cardiac therapy system comprising a leadless cardiac pacemaker (LCP) and the IMD, the IMD comprising:

a plurality of electrodes for sensing cardiac activity; and

operational circuitry configured to receive signals from the plurality of electrodes and analyze cardiac activity as follows;

sense a QRS complex; and

analyze the QRS complex to determine whether the QRS complex represents a fusion beat;

wherein the operational circuitry is further configured to communicate to the LCP that a pacing interval change is needed to attain fusion if the QRS complex does not represent a fusion beat;

wherein the operational circuitry is configured to analyze the QRS complex to determine whether the QRS complex represents a fusion beat by comparing the QRS complex to a template for a fusion beat.

2. The IMD of claim 1 wherein the operational circuitry is configured to analyze the QRS complex to determine whether the QRS complex represents a left ventricular (LV) paced beat or an intrinsic beat and to determine whether the pacing interval change is an increase or decrease as follows:

if the QRS complex represents an LV paced beat, determining that the pacing interval change is an increase in the pacing interval;

or

if the QRS complex represents an intrinsic beat, determining that the pacing interval change is a decrease in the pacing interval.

3. The IMD of claim 1 wherein the operational circuitry is configured to analyze the QRS complex to determine whether the QRS complex represents an intrinsic beat and to determine whether the pacing interval change is an increase or decrease as follows:

if the QRS complex resembles an intrinsic beat, determining that the pacing interval change is a decrease in the pacing interval;

or

otherwise determining that the pacing interval change is an increase in the pacing interval.

4. The IMD of claim 1 wherein the operational circuitry is configured to form the template for a fusion beat by sensing one or more fusion beats and storing the fusion beat template.

5. The IMD of claim 1 wherein the operational circuitry is configured to analyze the QRS complex by comparing it to each of a fusion beat template and at least one of a pace captured beat template and an intrinsic beat template.

6. An IMD system comprising the IMD of claim 1 and a leadless cardiac pacemaker (LCP), the LCP comprising control circuitry adapted to perform each of issuing pacing pulses and at least receiving communication signals from the IMD and adjusting timing of pacing pulses in response to the IMD communicating that a pacing interval change is needed, and at least two electrodes for delivering the pacing pulses.

7. An implantable medical device (IMD) configured for use as part of a cardiac therapy system comprising a leadless cardiac pacemaker (LCP) and the IMD, the IMD comprising:

a plurality of electrodes for sensing cardiac activity; and

operational circuitry configured to receive signals from the plurality of electrodes and analyze cardiac activity as follows;

sense a QRS complex; and

analyze the QRS complex to determine whether the QRS complex represents a fusion beat;

wherein the operational circuitry is further configured to communicate to the LCP that a pacing interval change is needed to attain fusion if the QRS complex does not represent a fusion beat;

wherein the operational circuitry is configured to analyze the QRS complex to determine whether the QRS complex represents a left ventricular (LV) paced beat and to determine whether the pacing interval change is an increase or decrease as follows;

if the QRS complex represents an LV paced beat, determining that the pacing interval change is an increase in the pacing interval;

or

otherwise determining that the pacing interval change is a decrease in the pacing interval.

8. An implantable medical device (IMD) configured for use as part of a cardiac therapy system comprising a leadless cardiac pacemaker (LCP) and the IMD, the IMD comprising:

a plurality of electrodes for sensing cardiac activity; and

operational circuitry configured to receive signals from the plurality of electrodes and monitor cardiac electrical signals to determine whether pacing therapy issued by the LCP is causing;

a) one or more fusion beats;

b) one or more pace captured beats;

or

c) one or more intrinsic beats; and

selectively communicating to the LCP to adjust pace timing if the pacing therapy is not causing one or more fusion beats.

9. The IMD of claim 8 wherein the operational circuitry is configured to selectively communicate to the LCP to adjust pace timing as follows:

if b), communicating an extension of the predetermined interval; and

if c), communicating a reduction of the predetermined interval.

10. The IMD of claim 8 wherein the operational circuitry is configured to monitor the cardiac electrical signals by:

obtaining a cardiac complex following a pace pulse delivery by the LCP; and

compare the cardiac complex to a fusion beat template in order to determine which of a), b), or c) resulted from the pacing pulse.

11. The IMD of claim 8 wherein, if (c), the operational circuitry is configured to determine a time at which the pacing pulse was delivered by the LCP relative to the intrinsic beat and analyze whether:

the pacing pulse was delivered too late to capture the heart of the patient and, to selectively communicate delivering the pacing pulse earlier for a subsequent cardiac cycle;

or

the pacing pulse was delivered at a time which likely cause a fusion beat and, if so, to selectively communicate an increase in at least one of pacing pulse amplitude or pacing pulse width for a subsequent pace pulse to be delivered by the LCP.

12. The IMD of claim 8 wherein the operational circuitry is configured to selectively communicate to the LCP after each detected cardiac beat.

13. The IMD of claim 8 wherein the operational circuitry is configured to selectively communicate to the LCP as follows:

if a), communication is performed at an interval;

or

if b) or c), communication is performed to adjust the pacing parameters after each determination that b) or c) is taking place.

14. The IMD of claim 8 wherein the IMD does not separately detect an atrial event in order to analyze the cardiac electrical signal.

15. An implantable system comprising the IMD of claim 8 and a leadless cardiac pacemaker (LCP), the LCP comprising control circuitry adapted to perform each of issuing pacing pulses and at least receiving communication signals from the IMD and adjusting timing of pacing pulses in response to the IMD communicating that a pacing interval change is needed, and at least two electrodes for delivering the pacing pulses.