Systems and methods for leadless cardiac resynchronization therapy

• US 10,086,206 B2
• Filed: 07/31/2017
• Issued: 10/02/2018
• Est. Priority Date: 11/21/2013
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Sambelashvili, Aleksandre T.
• Primary Examiner(s): Mahmood, Nadia A
• Application Number:
  US15/664,845
• Publication Number:
  US 20170340885A1
• Time in Patent Office: 428 Days
• Field of Search: 607 18
• 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 1/3684 for stimulating the heart at multiple sites of the ventricle or the atrium
• CPC Class Codes: A61N 1/36842 Multi-site stimulation in the same chamber
• CPC Class Codes: A61N 1/36843 Bi-ventricular stimulation
• CPC Class Codes: A61N 1/3688 configured for switching the pacing mode, e.g. from AAI to DDD
• CPC Class Codes: A61N 1/3756 Casings with electrodes thereon, e.g. leadless stimulators
• CPC Class Codes: A61N 1/39622 Pacing therapy

Abstract

Techniques and systems for monitoring cardiac arrhythmias and delivering electrical stimulation therapy using a subcutaneous device (e.g. subcutaneous implantable (SD)) and a leadless pacing device (LPD) are described. In one or more embodiments, a computer-implemented method includes sensing a first electrical signal from a heart of a patient through a SD. The first signal is stored into memory and serves as a baseline rhythm for a patient. Subsequently, a second signal is sensed from the heart through the SD. A cardiac condition can be detected within the sensed second electrical signal through the SD. A determination is made as to whether cardiac resynchronization therapy (CRT) is appropriate to treat the detected cardiac condition. A determination can then be made as to the timing of pacing pulse delivery to cardiac tissue through a leadless pacing device (LPD).

Claims

1. A method comprising:

sensing electrical signals from a patient'"'"'s heart using subcutaneous electrodes coupled to a subcutaneous device and located outside the patient'"'"'s ribcage;

determining, by the subcutaneous device, whether cardiac resynchronization pacing therapy (CRT pacing) is appropriate for the patient based upon the sensed electrical signals;

sending, by the subcutaneous device, a command signal to a leadless pacing device affixed to a wall of the patient'"'"'s left ventricle and delivering CRT pacing using the leadless pacing device in response to the command signal;

after sending the command signal, sensing subsequent electrical signals from the patient'"'"'s heart using the subcutaneous electrodes; and

determining, by the subcutaneous device based on the subsequent electrical signals, whether the CRT pacing provided efficacious resynchronization and whether the CRT pacing should be modified.

2. A method according to claim 1 wherein the leadless device is affixed to the epicardium of the patient'"'"'s left ventricle.

3. A method according to claim 1 further comprising:

sensing electrical signals from a patient'"'"'s heart using one or more electrodes coupled to the leadless pacing device;

determining, by the leadless pacing device, whether cardiac resynchronization pacing therapy (CRT pacing) is appropriate for the patient based upon the sensed electrical signals; and

sending a signal from the leadless pacing device indicating that CRT pacing is appropriate, to the subcutaneous device.

4. A method according to claim 1 wherein the determination by the leadless pacing device of whether CRT pacing is appropriate occurs in response to receipt of the command signal from the subcutaneous device by the leadless pacing device.

5. A method according to claim 4 wherein the determination by the subcutaneous device of whether CRT pacing is appropriate occurs in response to receipt of the signal from the leadless pacing device indicating that CRT pacing is appropriate, by the subcutaneous device.

6. A method according to claim 1 wherein the command signal from the subcutaneous device controls timing and delivery of the CRT pacing by the leadless pacing device.

7. A method according to claim 6 wherein in response to the determining, by the SD that CRT pacing should be modified, a subsequent signal is sent by the subcutaneous device to the leadless pacing device modifying the CRT pacing delivered by the leadless pacing device.

8. A method, comprising:

using a system implanted in a patient to deliver cardiac resynchronization pacing therapy, the system comprising a subcutaneously implanted device and leadless pacing devices attached to the patient'"'"'s right and left ventricles;

the method comprising;

sensing electrical signals from a patient'"'"'s heart using subcutaneous electrodes coupled to the subcutaneous device and located outside the patient'"'"'s ribcage;

determining, by the subcutaneous device, whether cardiac resynchronization pacing therapy (CRT pacing) is appropriate for the patient based upon the sensed electrical signals and whether the CRT pacing should be fusion pacing or biventricular pacing;

sending, from the subcutaneous device, signals to the leadless pacing devices indicative of whether the CRT pacing should be fusion pacing or biventricular pacing; and

thereafter delivering the indicated one of fusion or biventricular pacing using the leadless pacing devices.

9. A method according to claim 8, further comprising:

sensing electrical signals from a patient'"'"'s heart using one or more electrodes coupled to the leadless pacing devices;

determining, by the leadless pacing devices, whether cardiac resynchronization pacing therapy (CRT pacing) is appropriate for the patient based upon the sensed electrical signals and whether the CRT pacing should be fusion pacing or biventricular pacing; and

sending a signal from the leadless pacing devices indicating whether the CRT pacing should be fusion pacing or biventricular pacing, to the subcutaneous device.

10. A method according to claim 9 wherein the determination by the leadless pacing devices of whether CRT pacing is appropriate occurs in response to receipt of the signal from the subcutaneous device, by the leadless pacing device.

11. A method according to claim 9 wherein the determination by the subcutaneous device of whether the CRT pacing should be fusion pacing or biventricular pacing is appropriate occurs in response to receipt of the signal from the leadless pacing device, by the subcutaneous device.

12. A method according to claim 8 wherein the leadless pacing device attached to the patient'"'"'s right ventricle is located in the patient'"'"'s right ventricle.

13. A method according to claim 8 wherein the leadless pacing device attached to the patient'"'"'s left ventricle is affixed to the epicardium of the patient'"'"'s left ventricle.

14. A system comprising:

a leadless pacing device including means for fixation to a patient'"'"'s heart wall;

a subcutaneous device comprising;

subcutaneous electrodes adapted for location outside the patient'"'"'s ribcage;

means for sensing electrical signals from a patient'"'"'s heart using the subcutaneous electrodes;

means for determining whether cardiac resynchronization pacing therapy (CRT pacing) is appropriate for the patient based upon the sensed electrical signals;

means for sending, a command signal to the leadless pacing device in response to the determination; and

wherein the leadless pacing device further comprises means for delivering CRT pacing in response to the command signal; and

wherein the subcutaneous device further comprises means for sensing subsequent electrical signals from the patient'"'"'s heart using the subcutaneous electrodes after sending the command signal; and

means for determining, by the subcutaneous device based on the subsequent electrical signals, whether the CRT pacing provided efficacious resynchronization and whether the CRT pacing should be modified.

15. A system, comprising:

a subcutaneous device comprising subcutaneous electrodes adapted for location outside the patient'"'"'s rib cage and leadless pacing devices adapted for attachment to the patient'"'"'s right and left ventricles;

the subcutaneous device comprising;

means for sensing electrical signals from a patient'"'"'s heart using the subcutaneous electrodes;

means for determining, whether cardiac resynchronization pacing therapy (CRT pacing) is appropriate for the patient based upon the sensed electrical signals and whether the CRT pacing should be fusion pacing or biventricular pacing; and

means for sending, from the subcutaneous device, signals to the leadless pacing devices indicative of whether the CRT pacing should be fusion pacing or biventricular pacing; and

wherein the leadless pacing devices comprise means for delivering the indicated one of fusion or biventricular pacing using the leadless pacing devices responsive to the signals from the subcutaneous device.