Cardiac therapy system using subcutaneously sensed P-waves for resynchronization pacing management

• US 10,512,784 B2
• Filed: 06/26/2017
• Issued: 12/24/2019
• Est. Priority Date: 06/27/2016
• Status: Active Grant

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Hahn, Stephen J., Siejko, Krzysztof Z., Linder, William J., Maile, Keith R., Brisben, Amy Jean, Herrmann, Keith L., Koop, Brendan E., Haasl, Benjamin J.
• Primary Examiner(s): Levicky, William J
• Application Number:
  US15/633,517
• Publication Number:
  US 20170368360A1
• Time in Patent Office: 911 Days
• CPC Class Codes: A61B 5/0006 ECG or EEG signals
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• CPC Class Codes: A61B 5/349 Detecting specific parameters of the electrocardiograph cycle
• CPC Class Codes: A61B 5/352 Detecting R peaks, e.g. for synchronising diagnostic apparatus; Estimating R-R interval
• CPC Class Codes: A61B 5/363 Detecting tachycardia or bradycardia
• CPC Class Codes: A61B 5/4836 Diagnosis combined with treatment in closed-loop systems or methods A61B5/0036 takes precedence
• CPC Class Codes: A61B 5/686 Permanently implanted devices, e.g. pacemakers, other stimulators, biochips A61B5/6861 takes precedence
• CPC Class Codes: A61B 5/726 using Wavelet transforms
• 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 1/365 controlled by a physiological parameter, e.g. heart potential evoked response A61N1/371
• CPC Class Codes: A61N 1/36507 controlled by gradient or slope of the heart potential
• CPC Class Codes: A61N 1/36514 controlled by a physiological quantity other than heart potential, e.g. blood pressure controlled by two or more physical parameters A61N1/36585
• CPC Class Codes: A61N 1/3684 for stimulating the heart at multiple sites of the ventricle or the atrium
• CPC Class Codes: A61N 1/37288 Communication to several implantable medical devices within one patient
• 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 1/3956 Implantable devices for applying electric shocks to the heart, e.g. for cardioversion
• CPC Class Codes: A61N 1/3962 in combination with another heart therapy

Abstract

Systems, methods and implantable devices configured to provide cardiac resynchronization therapy and/or bradycardia pacing therapy. A first device located in the heart of the patient is configured to receive a communication from a second device and deliver a pacing therapy in response to or in accordance with the received communication. A second device located elsewhere is configured to determine an atrial event has occurred and communicate to the first device to trigger the pacing therapy. The second device may be configured for sensing the atrial event by the use of vector selection and atrial event windowing, among other enhancements. Exception cases are discussed and handled as well.

Claims

1. An implantable medical device comprising:

a lead comprising a plurality of implantable electrodes including at least first and second sensing electrodes separated by a defibrillation coil;

a housing containing operational circuitry for analyzing signals captured using the plurality of implantable electrodes, the housing also including at least one electrode; and

communication circuitry configured to communicate with a second implantable medical device;

wherein the operational circuitry is configured to perform an initialization sequence for detecting an atrial event, the initialization sequence comprising;

detecting at least first and second cardiac cycles of a patient;

establishing a window for detection of the atrial event by sensing when atrial events occurs relative to ventricular events of the first and second cardiac cycles, wherein the window for detection is adjustable relative to a beat rate of the patient;

wherein the operational circuitry is configured to observe cardiac signals of the patient during the window for detection of the atrial event in order to detect the atrial event by sensing a pacing output from a first medical device or a ventricular event of the patient, determining when the window for detection of the atrial event will start, and sensing the atrial event in the window; and

wherein the operational circuitry is configured to use the communication circuitry to issue a communication to the second implantable medical device in response to detecting an atrial event in the window for detection of the atrial event.

2. The implantable medical device of claim 1 wherein the operational circuitry is configured to calculate a composite cardiac cycle data set using the at least first and second cardiac cycles, and to use the composite cardiac cycle data set to establish the window for detection of the atrial event.

3. An implantable device system comprising:

a first medical device configured to deliver a pacing therapy to a heart of a patient, the first medical device comprising a housing adapted for placement in the heart of the patient, a pulse generator adapted for issuing pacing pulses, and at least first and second electrodes coupled to the pulse generator, and a first communications module adapted for communicating with other medical devices either via an antenna or using the electrodes; and

a second medical device configured to sense activity of the heart of the patient, the second medical device comprising a processor adapted for sensing cardiac activity and a plurality of electrodes coupled to input/output circuitry adapted to provide a signal to the processor, the second medical device including communication circuitry for communicating at least to the first communications module;

wherein the second medical device processor is configured for an initialization sequence to use the input/output circuitry for detecting an atrial event, the initialization sequence comprising;

detecting at least first and second cardiac cycles of the patient; and

establishing a window for detection of the atrial event by sensing when atrial events occur relative to ventricular events of the first and second cardiac cycles, wherein the window for detection is adjustable relative to a beat rate of the patient;

wherein the second medical device is configured to observe cardiac signals of the patient during the window for detection of the atrial event in order to detect the atrial event;

wherein the first medical device is configured to receive communication from the second medical device;

wherein the second medical device is configured to detect the atrial event in the heart of the patient and issue a communication to the first medical device, by sensing a pacing output of the first medical device or a ventricular event of the patient, determining when the window for detection of the atrial event will start, and sensing the atrial event in the window;

wherein the first medical device is configured to deliver therapy to the heart of the patient in response to the communication issued by the second medical device.

4. The system of claim 3 wherein the second medical device is configured to establish the window for detection of the atrial event relative to a feature of a ventricular event.

5. The system of claim 3 wherein the second medical device is configured to calculate a composite cardiac cycle data set using the at least first and second cardiac cycles, and to establish the window for detection of the atrial event using the composite cardiac cycle data set.

6. The system of claim 3 wherein the initialization sequence further comprises determining characteristics for the atrial event, further wherein the second medical device is configured to use the characteristics determined during the initialization sequence in order to detect the atrial event, wherein the characteristics for the atrial event comprise at least one of:

an amplitude;

a relative amplitude as compared to one or more preceding ventricular events;

a relative amplitude as compared to a mean amplitude during a cardiac cycle;

or

a maximum or minimum slope.

7. The system of claim 3 wherein the second medical device is configured to determine whether a signal captured during the window for detection of the atrial event matches a stored atrial event template or a dynamic atrial event template by comparing the signal during the window to a template in a rolling comparison to seek a match to the template.

8. The system of claim 3 wherein the second medical device is configured to perform a sensing vector selection routine in which:

the second medical device analyzes signals from a plurality of sensing vectors defined by the plurality of electrodes and selects a first sensing configuration for detection of ventricular events; and

the second medical device analyzes signals from a plurality of sensing vectors defined by the plurality of electrodes and selects a second sensing configuration for detection of atrial events.

9. The system of claim 8 wherein the second medical device is configured to selectively use the second sensing configuration to determine whether an atrial event takes place in the atrial sensing window.

10. The system of claim 8 wherein the second medical device is configured to determine one or more parameters for sensing of atrial events using the second sensing configuration.

11. The system of claim 8 wherein the second medical device is configured to establish a template for atrial events to use to determine whether a signal captured using the second sensing configuration is an atrial event of a predetermined type by comparing the signal during the window to a template in a rolling comparison to seek a match to the template.

12. The system of claim 3 wherein the communication is configured to indicate that the second medical device has detected the atrial event, and the first medical device is configured to determine when the therapy is to be delivered relative to timing of the atrial event.

13. The system of claim 3 wherein the communication is configured to command delivery of the therapy by the first device at a particular time.

14. The system of claim 3 wherein the first medical device is a leadless cardiac pacemaker, and the second medical device is an implantable cardiac monitor.

15. The system of claim 3 wherein the first medical device is a leadless cardiac pacemaker, and the second medical device is a subcutaneous implantable defibrillator comprising a housing coupled to a lead, the housing adapted for placement in the left axilla of the patient and having a sensing electrode thereon, and the lead adapted to extend from the left axilla of the patient to the sternum of the patient and thence parasternally toward the head of the patient, the lead having first and second electrodes thereon on either side of a defibrillation coil.