Method and device for three-stage atrial cardioversion therapy

• US 9,814,895 B2
• Filed: 02/26/2016
• Issued: 11/14/2017
• Est. Priority Date: 12/11/2007
• Status: Active Grant

• Current Assignee: Washington University In St Louis
• Original Assignee: Washington University In St Louis
• Inventors: Efimov, Igor R., Li, Wenwen, Janardhan, Ajit
• Primary Examiner(s): Layno, Carl H
• Assistant Examiner(s): Morales, Jon Eric C
• Application Number:
  US15/054,885
• Publication Number:
  US 20160243372A1
• Time in Patent Office: 627 Days
• Field of Search: 607 5, 607 14
• CPC Class Codes: A61N 1/3624 occurring in the atrium, i.e. atrial tachycardia
• CPC Class Codes: A61N 1/3906 characterised by the form of the shockwave
• CPC Class Codes: A61N 1/395 for treating atrial fibrillation
• CPC Class Codes: A61N 1/3956 Implantable devices for applying electric shocks to the heart, e.g. for cardioversion
• CPC Class Codes: A61N 1/3987 characterised by the timing or triggering of the shock

Abstract

Methods and apparatus for a three-stage atrial cardioversion therapy that treats atrial arrhythmias within pain tolerance thresholds of a patient. An implantable therapy generator adapted to generate and selectively deliver a three-stage atrial cardioversion therapy and at least two leads, each having at least one electrode adapted to be positioned proximate the atrium of the patient. The device is programmed for delivering a three-stage atrial cardioversion therapy via both a far-field configuration and a near-field configuration of the electrodes upon detection of an atrial arrhythmia. The three-stage atrial cardioversion therapy includes a first stage for unpinning of one or more singularities associated with an atrial arrhythmia, a second stage for anti-repinning of the one or more singularities, both of which are delivered via the far-field configuration of the electrodes, and a third stage for extinguishing of the one or more singularities delivered via the near-field configuration of the electrodes.

Claims

1. An implantable therapy generator, comprising:

detection circuitry configured to evaluate one or more sensed cardiac signals representative of atrial activity and detect an atrial arrhythmia;

control circuitry operably connected to the detection circuitry that, in response to the atrial arrhythmia, controls generation and selective delivery of a therapy without confirmation of conversion of the atrial arrhythmia during the therapy, the therapy including;

a first stage set of electrical pulses delivered via a first implantable electrode within a ventricular refractory period to destabilize a reentry associated with the atrial arrhythmia; and

a second stage set of electrical pulses delivered via at least two of the first implantable electrode and a second implantable electrode, the second stage set of electrical pulses to terminate the reentry;

wherein the first stage and the second stage are separated by a delay having a duration between 50 to 400 milliseconds,

wherein the first implantable electrode comprises a far field electrode, and wherein the second implantable electrode comprises a near field electrode,

wherein the far field electrode is a portion of an exterior surface of a housing of the implantable therapy generator.

2. The implantable therapy generator of claim 1, wherein the second stage is delivered via at least two of the first implantable electrode and at least one of the second implantable electrodes.

3. The implantable therapy generator of claim 1, wherein the therapy comprises an atrial cardioversion therapy.

4. The implantable therapy generator of claim 1, wherein the first stage has a total duration of less than one atrial cycle length and includes at least two and less than ten electrical pulses of at least 10 volts and not more than 100 volts, the atrial cycle length determined by the detection circuitry based on the one or more sensed cardiac signals;

and

the second stage includes at least five and less than ten pulses of less than 50% of a ventricular far-field excitation threshold with a pulse coupling interval between electrical pulses of between 70-100% of the atrial cycle length.

5. The implantable therapy generator of claim 1, wherein the therapy is delivered in a sequence of one of the first stage and one of the second stage.

6. The implantable therapy generator of claim 1, wherein the first stage and the second stage are delivered in accordance with a set of therapy parameters for the electrical pulses of each stage that are programmed in response to feedback of a patient in whom the apparatus is implanted so as to provide an effective treatment of the atrial arrhythmia for the patient at a pain sensation that is tolerable to the patient.

7. The implantable therapy generator of claim 1, further comprising a heuristic learning algorithm configured to dynamically modify a set of therapy parameters for the electrical pulses of each stage in response to an effectiveness of the therapy.

8. The implantable therapy generator of claim 1, wherein the first stage consists of two electrical pulses.

9. The implantable therapy generator of claim 1, wherein the first stage set of electrical pulses comprises biphasic pulses.

10. An implantable therapy generator, comprising:

detection circuitry configured to evaluate one or more sensed cardiac signals representative of atrial activity and detect an atrial arrhythmia; and

control circuitry operably connected to the detection circuitry that, in response to the atrial arrhythmia, controls generation and delivery of a therapy without confirmation of conversion of the atrial arrhythmia during the therapy, the therapy including;

a first stage set of electrical pulses delivered via a first implantable electrode within a ventricular refractory period to unpin one or more singularities associated with the atrial arrhythmia;

a second stage set of electrical pulses delivered via the first implantable electrode to inhibit repinning of the one or more singularities; and

a third stage set of electrical pulses delivered via a second implantable electrode to extinguish the one or more singularities;

wherein each stage is separated by an inter-stage delay and wherein at least one of the inter-stage delays has a duration of between 50 to 400 milliseconds.

11. The implantable therapy generator of claim 10, wherein the first implantable electrode comprises a far field electrode, and wherein the second implantable electrode comprises a near field electrode.

12. The implantable therapy generator of claim 11, wherein the far field electrode is a portion of an exterior surface of a housing of the implantable therapy generator.

13. The implantable therapy generator of claim 10, wherein the second stage is delivered via at least two of the first implantable electrode and at least one of the second implantable electrodes.

14. The implantable therapy generator of claim 10, wherein the therapy comprises an atrial cardioversion therapy.

15. The implantable therapy generator of claim 10, wherein the first stage has a total duration of less than one atrial cycle length and includes at least two and less than ten electrical pulses of at least 10 volts and not more than 100 volts, the atrial cycle length determined by the detection circuitry based on the one or more sensed cardiac signals;

the second stage includes at least five and less than ten electrical pulses of less than 50% of a ventricular far-field excitation threshold with a pulse coupling interval between pulses of between 70-100% of the atrial cycle length; and

the third stage includes at least five and less than ten near field pulses at a voltage of up to three times an atrial capture threshold with a pulse duration of more than 0.2 and less than 5 milliseconds and a pulse coupling interval of between 70-100% of the atrial cycle length.

16. The implantable therapy generator of claim 10, wherein the therapy is delivered in a sequence of one of the first stage, one of the second stage and one of the third stage.

17. The implantable therapy generator of claim 10, wherein the therapy is delivered in sequence of one of the first stage, one of the second stage, one of the first stage, one of the second stage and one of the third stage.

18. The implantable therapy generator of claim 10, wherein the therapy is delivered in accordance with a set of therapy parameters for the electrical pulses of each stage that are programmed in response to feedback of a patient in whom the apparatus is implanted so as to provide an effective treatment of the atrial arrhythmia for the patient at a pain sensation that is tolerable to the patient.

19. The implantable therapy generator of claim 10, further comprising a heuristic learning algorithm configured to dynamically modify a set of therapy parameters for the pulses of each stage in response to an effectiveness of the therapy.

20. The implantable therapy generator of claim 10, wherein the first stage consists of two electrical pulses.

21. The implantable therapy generator of claim 10, wherein the first stage has a total duration of 30% to 50% of one cycle length of the atrial arrhythmia, the cycle length determined by the detection circuitry based on the one or more sensed cardiac signals.

22. The implantable therapy generator of claim 10, wherein the first stage electrical pulses comprise biphasic pulses.

23. A method, comprising:

providing an implantable therapy generator configured for coupling to a plurality of implantable electrodes; and

providing instructions recorded on at least one tangible medium and including;

implanting the therapy generator and the plurality of electrodes within a patient; and

causing the implanted therapy generator to deliver a three-stage atrial arrhythmia therapy which includes a first stage delivered to the at least one far field electrode for unpinning of one or more singularities associated with an atrial arrhythmia, a second stage delivered to the at least one far field electrode for anti-repinning of the one or more singularities associated with the atrial arrhythmia, and a third stage delivered to the at least one near field electrodes for extinguishing of the one or more singularities associated with the atrial arrhythmia, wherein each stage is separated by an inter-stage delay and wherein at least one of the inter-stage delays has a duration of between 50 to 400 milliseconds.

24. The method of claim 23, wherein the instructions for implanting the therapy generator and the plurality of electrodes further include implanting at least one far field electrode and at least one near field electrode proximate an atrium of a heart of the patient.

25. An implantable therapy generator, comprising:

detection circuitry configured to evaluate one or more sensed cardiac signals representative of atrial activity and detect an atrial arrhythmia;

control circuitry operably connected to the detection circuitry that, in response to the atrial arrhythmia, controls generation and selective delivery of a therapy without confirmation of conversion of the atrial arrhythmia during the therapy, the therapy including;

a first stage set of electrical pulses delivered via a first implantable electrode within a ventricular refractory period to destabilize a reentry associated with the atrial arrhythmia; and

a second stage set of electrical pulses delivered via at least two of the first implantable electrode and a second implantable electrode, the second stage set of electrical pulses to terminate the reentry;

wherein the first stage and the second stage are separated by a delay having a duration between 50 to 400 milliseconds

wherein the first stage has a total duration of 30% to 50% of one cycle length of the atrial arrhythmia, the cycle length determined by the detection circuitry based on the one or more sensed cardiac signals.