Method and device for three-stage atrial cardioversion therapy

• US 8,706,216 B2
• Filed: 01/12/2012
• Issued: 04/22/2014
• 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, Li, Wenwen, Janardhan, Ajit
• Primary Examiner(s): Layno, Carl H
• Assistant Examiner(s): Morales, Jon Eric C
• Application Number:
  US13/349,517
• Publication Number:
  US 20120209343A1
• Time in Patent Office: 831 Days
• Field of Search: 607 4- 5, 607/10, 607/14, 607/28
• US Class Current: 607/5
• 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. A three-stage atrial arrhythmia treatment apparatus, comprising:

at least one electrode adapted to be implanted proximate an atrium of a heart of a patient to deliver far field pulses;

at least one electrode adapted to implanted proximate the atrium of the heart of the patient to deliver near field pulses and sense cardiac signals;

an implantable therapy generator adapted to be implanted in a patient and operably connected to the electrodes, including;

sensing circuitry that senses cardiac signals representative of atrial activity and ventricular activity;

detection circuitry operably connected to the sensing circuitry to evaluate the cardiac signals representative of atrial activity to determine an atrial cycle length and detect an atrial arrhythmia based at least in part on the atrial cycle length;

control circuitry operably connected to the sensing circuitry that, in response to the atrial arrhythmia, controls generation and selective delivery of a three-stage atrial cardioversion therapy to the electrodes with each stage having an inter-stage delay of between 50 to 400 milliseconds and without confirmation of conversion of the atrial arrhythmia during the three-stage atrial cardioversion therapy; and

therapy circuitry operably connected to the electrodes and the control circuitry including;

at least one first stage charge storage circuit selectively coupled to the at least one far field electrode that selectively stores energy for a first stage of the three-stage atrial cardioversion therapy having at least two and less than ten atrial cardioversion pulses of at least 10 volts and not more than 100 volts, wherein the first stage has a total duration of less than one cycle lengths of the atrial arrhythmia and is delivered within a ventricular refractory period to unpin one or more singularities associated with the atrial arrhythmia;

at least one second stage charge storage circuit selectively coupled to the at least one far field electrode that selectively stores a second stage of the three-stage atrial cardioversion therapy having at least five and less than ten far field pulses of less than 50% of a ventricular far-field excitation threshold with pulse coupling interval of between 70-100% of the cycle length of the atrial arrhythmia, wherein the second stage prevents repinning of the one or more singularities associated with the atrial arrhythmia that are unpinned by the first stage; and

at least one third stage charge storage circuit selectively coupled to the near field electrode that selectively stores a third stage of the three-stage cardioversion therapy having at least five and less than ten near field pulses at a voltage of up to three times the 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 cycle length of the atrial arrhythmia, wherein the third stage extinguishes the one or more singularities associated with the atrial arrhythmia that are unpinned by the first stage and prevented from repinning by the second stage; and

a battery system operably coupled and providing power to the sensing circuitry, the detection circuitry, the control circuitry and the therapy circuitry.

2. The apparatus of claim 1, wherein the first charge storage circuit includes at least one output capacitor configuration and a high voltage transformer electrically coupled to the battery system to charge the at least one output capacitor configuration.

3. The apparatus of claim 1, wherein the first charge storage circuit includes at least one output capacitor configuration and a charge pump electrically coupled to the battery system to charge the at least one output capacitor configuration.

4. The apparatus of claim 1, wherein the second charge storage circuit and third charge storage circuit include a single low voltage output capacitor configuration and switching circuitry between the single low voltage output capacitor configuration and the far field electrodes and the near field electrodes.

5. The apparatus of claim 1, wherein the control circuitry includes an H-bridge switching circuit operably connected to the electrodes to enable delivery of biphasic pulses.

6. The apparatus of claim 1, wherein the control circuitry controls delivery of the three-stage atrial cardioversion therapy to deliver in sequence one of the first stage, one of the second stage and one of the third stage.

7. The apparatus of claim 1, wherein the control circuitry controls delivery of the three-stage atrial cardioversion therapy to deliver in sequence 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.

8. The apparatus of claim 1, wherein the apparatus and the at least two leads include at least four far-field electrodes and the control circuitry is configured to selectively excite combinations of the far-field electrodes to create a plurality of different electric fields between different ones of the far-field electrodes to deliver a rotating set of electrical fields as a phased unpinning far-field therapy generated by the at least one first stage charge storage circuit and the at least one second stage charge storage circuit.

9. The apparatus of claim 1, wherein the control circuitry delivers each of the first stage, the second stage, and the third stage in accordance with a set of therapy parameters for the 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.

10. The apparatus of claim 9, wherein the control circuitry comprises a microprocessor programmed with a heuristic learning algorithm that dynamically modifies settings of the set of therapy parameters for the pulses of each stage in response to an effectiveness of the three-stage atrial cardioversion therapy.

11. The apparatus of claim 1, wherein the pulse coupling interval of the first stage and the second stage is 88% of the atrial arrhythmia cycle length.

12. The apparatus of claim 1, wherein the first stage pulses are at least 10 volts and not more than 30 volts.

13. The apparatus of claim 1, wherein the first stage consists of two pulses.

14. The apparatus of claim 1, wherein the first stage has a total duration of 30% to 50% of one cycle length of the atrial arrhythmia.

15. The apparatus of claim 1, wherein each pulse of the first stage includes a total energy of 0.1 J or less.

16. The apparatus of claim 1, wherein the first stage pulses comprise biphasic pulses.

17. An atrial arrhythmia treatment apparatus, comprising:

an implantable therapy generator adapted to be implanted in a patient, including;

means for detecting an atrial arrhythmia and determining a cycle length of the atrial arrhythmia;

means for generating a three-stage atrial cardioversion therapy, including;

means for generating a first stage of the three-stage atrial cardioversion therapy having at least two and less than ten biphasic atrial cardioversion pulses of 10 volts to 100 volts for unpinning of one or more singularities associated with an atrial arrhythmia, wherein the first stage has a total duration of 30% to 50% of the cycle lengths of the atrial arrhythmia and is delivered within a ventricular refractory period;

means for generating a second stage of the three-stage atrial cardioversion therapy having at least five and less than ten far field pulses of less than a ventricular far-field excitation threshold with a pulse coupling interval of between 70-100% of the cycle length of the atrial arrhythmia for anti-repinning of the one or more singularities associated with the atrial arrhythmia; and

means for generating a third stage of the three-stage cardioversion therapy having at least five and less than ten near field pulses of one-and-a-half times to three-times the atrial capture threshold and a pulse coupling interval of between 70-100% of the cycle length of the atrial arrhythmia for extinguishing of the one or more singularities associated with the atrial arrhythmia; and

means for controlling delivery of the three-stage atrial cardioversion therapy in response to detection of the atrial arrhythmia with each stage having an inter-stage delay of between 50 to 400 milliseconds and without confirmation of conversion of the atrial arrhythmia until after delivery of the third stage; and

at least two leads adapted to be operably connected to the implantable therapy generator, each lead having at least one electrode adapted to be positioned proximate an atrium of a heart of the patient through which the three-stage atrial cardioversion therapy is selectively delivered to the atrium of the heart,

such that the means for generating the first stage and the means for generating the second stage are selectively coupled by the means for controlling delivery to a far-field configuration of the electrodes and the means for generating the third stage are selectively coupled by the means for controlling delivery to a near-field configuration of the electrodes.

18. The apparatus of claim 17, wherein the means for controlling delivery of the three-stage atrial cardioversion therapy delivers in sequence one of the first stage, one of the second stage and one of the third stage.

19. The apparatus of claim 17, wherein the means for controlling delivery of the three-stage atrial cardioversion therapy delivers in sequence 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.

20. The apparatus of claim 17, wherein the apparatus and the at least two leads include at least four far-field electrodes and the means for controlling delivery of the three-stage atrial cardioversion therapy is configured to selectively excite combinations of the far-field electrodes to create a plurality of different electric fields between different ones of the far-field electrodes to deliver a rotating set of electrical fields as a phased unpinning far-field therapy generated by the means for generating the first stage and the means for generating the second stage.

21. The apparatus of claim 17, wherein the means for controlling delivery of the three-stage atrial cardioversion therapy delivers each of the first stage, the second stage, and the third stage in accordance with a set of therapy parameters for the 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

22. The apparatus of claim 21, wherein the means for controlling delivery further comprises a heuristic learning algorithm that dynamically modifies settings of the set of therapy parameters for the pulses of each stage in response to an effectiveness of the three-stage atrial cardioversion therapy.

23. The apparatus of claim 17, wherein the means for generating the three-stage atrial cardioversion therapy includes a battery system and the means for generating the first stage includes at least one output capacitor configuration and a high voltage transformer electrically coupled to the battery system to charge the at least one output capacitor configuration.

24. The apparatus of claim 17, wherein the means for generating the three-stage atrial cardioversion therapy includes a battery system and the means for generating the first stage includes at least one output capacitor configuration and a charge pump electrically coupled to the battery system to charge the at least one output capacitor configuration.

25. The apparatus of claim 24, wherein the means for generating the first stage includes a plurality of output capacitor configurations, one for each biphasic atrial cardioversion pulse, and the charge pump alternatively trickle charges each of the plurality of output capacitor configurations.

26. The apparatus of claim 17, wherein the at least two leads include a first lead having at least one far-field electrode and a second lead having at least one near-field electrode, and wherein the implantable pulse generator includes at least a portion of a housing of the implantable pulse generator that serves as a far-field electrode.

27. A method of treating atrial arrhythmias comprising:

(a) providing an atrial arrhythmia treatment device including an implantable therapy generator adapted to generate and selectively deliver a three-stage atrial cardioversion therapy and at least two leads operably connected to the implantable therapy generator, each lead having at least one electrode adapted to be positioned proximate the atrium of a heart of the patient;

(b) providing instructions for implanting the atrial arrhythmia treatment device in a patient during a surgical procedure;

(c) providing instructions for configuring the atrial arrhythmia treatment device at a time after completion of the surgical procedure, including instructions for programming the atrial arrhythmia treatment device with a set of therapy parameters for delivering a three-stage atrial cardioversion therapy to a patient via both a far-field configuration and a near-field configuration of the electrodes upon detection of an atrial arrhythmia by the atrial arrhythmia treatment device,

wherein the three-stage atrial cardioversion therapy includes;

a first stage of the three-stage atrial cardioversion therapy having at least two and less than ten atrial cardioversion pulses of at least 10 volts and not more than 100 volts for unpinning of one or more singularities associated with an atrial arrhythmia, the first stage having a total duration of less than two cycle lengths of the atrial arrhythmia and being delivered within a ventricular refractory period;

a second stage of the three-stage atrial cardioversion therapy having at least five and less than ten far field pulses of less than a ventricular far-field excitation threshold with a pulse duration of more than 5 and less than 20 milliseconds and a pulse coupling interval of between 70-100% of the cycle length of the atrial arrhythmia for anti-repinning of the one or more singularities associated with the atrial arrhythmia; and

a third stage of the three-stage cardioversion therapy having at least five and less than ten near field pulses at a voltage ranging from substantially one-and-a-half to three times the 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 cycle length of the atrial arrhythmia for extinguishing of the one or more singularities associated with the atrial arrhythmia, and

wherein the three-stage atrial cardioversion therapy is delivered in response to detection of the atrial arrhythmia with each stage having an inter-stage delay of between 50 to 400 milliseconds and without confirmation of conversion of the atrial arrhythmia until after delivery of the third stage.