Method and device for three-stage atrial cardioversion therapy

• US 9,289,620 B2
• Filed: 04/21/2014
• Issued: 03/22/2016
• 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:
  US14/257,620
• Publication Number:
  US 20150045847A1
• Time in Patent Office: 701 Days
• Field of Search: 607/5, 607/14
• US Class Current: 1/1
• 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 method for controlling an implantable therapy generator adapted to be implanted in a patient and operably connected to at least one far field electrode and at least two near field electrodes to sense cardiac signals and deliver atrial arrhythmia therapy to the patient, the method comprising configuring the implantable therapy generator to:

detect an atrial arrhythmia based on evaluation of cardiac signals; and

in response to the atrial arrhythmia, deliver an atrial cardioversion therapy without confirmation of conversion of the atrial arrhythmia during the atrial cardioversion therapy, the atrial cardioversion therapy having at least three stages including;

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

a first inter-stage delay subsequent to the first stage set of pulses;

a second stage set of pulses delivered via the at least one far field electrode to inhibit repinning of the one or more singularities;

a second inter-stage delay subsequent to the second stage set of pulses;

a third stage set of pulses delivered via the at least two near field electrodes to extinguish the one or more singularities;

wherein at least one of the inter-stage delays has a duration of between 50 to 400 milliseconds.

2. The method of claim 1, wherein evaluation of cardiac signals includes determination of an atrial cycle length and configuring the implantable therapy generator is performed such that:

the first stage includes at least two and less than ten atrial cardioversion pulses of at least 10 volts and not more than 100 volts;

the second stage includes at least five and less than ten far field pulses with a pulse coupling interval between far field 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.

3. The method of claim 1, wherein configuring the implantable therapy generator is performed such that the atrial cardioversion therapy is delivered in a sequence of one of the first stage, one of the second stage and one of the third stage.

4. The method of claim 1, wherein configuring the implantable therapy generator is performed such that the atrial cardioversion therapy is delivered in a 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.

5. The method of claim 1, wherein configuring the implantable therapy generator is performed such that each of the first stage, the second stage, and the third stage are delivered in accordance with a set of therapy parameters for the pulses of each stage that are programmed in response to feedback of the patient so as to provide an effective treatment of the atrial arrhythmia for the patient at a pain sensation in response to the atrial cardioversion therapy that is tolerable to the patient.

6. The method of claim 1, wherein configuring the implantable therapy generator is performed such that a heuristic learning algorithm dynamically modifies a set of therapy parameters for the pulses of each stage in response to an effectiveness of the atrial cardioversion therapy.

7. The method of claim 1, wherein evaluation of cardiac signals includes determination of an atrial cycle length and configuring the implantable therapy generator is performed such that a pulse coupling interval of the first stage and the second stage is between 70-100% of an atrial arrhythmia cycle length.

8. The method of claim 1, wherein configuring the implantable therapy generator is performed such that the first stage pulses are at least 10 volts and not more than 100 volts.

9. The method of claim 1, wherein configuring the implantable therapy generator is performed such that the first stage consists of two pulses.

10. The method of claim 1, wherein evaluation of cardiac signals includes determination of an atrial cycle length and configuring the implantable therapy generator is performed such that the first stage has a total duration of less than the atrial cycle length.

11. The method of claim 1, wherein configuring the implantable therapy generator is performed such that the first stage pulses comprise biphasic pulses.

12. A method for delivering atrial arrhythmia therapy to a patient, the method comprising:

implanting an implantable therapy generator in the patient;

implanting at least one far field electrode and at least two near field electrodes proximate an atrium of a heart of the patient that are operably connected to the implantable therapy generator; and

causing the implantable therapy generator to;

sense and evaluate cardiac signals to detect an atrial arrhythmia; and

in response to the atrial arrhythmia, deliver an atrial cardioversion therapy without confirmation of conversion of the atrial arrhythmia during the atrial cardioversion therapy, the atrial cardioversion therapy having at least three stages including;

a first stage set of pulses delivered via the at least one far field electrode within a ventricular refractory period to unpin a reentry wave associated with the atrial arrhythmia;

a first inter-stage delay subsequent to the first stage;

a second stage set of pulses delivered via the at least one far field electrode to inhibit repinning of the reentry wave;

a second inter-stage delay subsequent to the second stage; and

a third stage set of pulses delivered via the at least two near field electrodes to extinguish the reentry wave;

wherein at least one of the inter-stage delays has a duration of between 50 to 400 milliseconds.

13. The method of claim 12, wherein sense and evaluate cardiac signals includes determination of an atrial cycle length and deliver the atrial cardioversion therapy is performed such that:

the first stage includes at least two and less than ten atrial cardioversion pulses of at least 10 volts and not more than 100 volts;

the second stage includes at least five and less than ten far field pulses with a pulse coupling interval between far field 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.

14. The method of claim 12, wherein deliver the atrial cardioversion therapy is performed such that the atrial cardioversion therapy is delivered in a sequence of one of the first stage, one of the second stage and one of the third stage.

15. The method of claim 12, wherein deliver the atrial cardioversion therapy is performed such that the atrial cardioversion 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.

16. The method of claim 12, wherein deliver the atrial cardioversion therapy is performed such that each of the first stage, the second stage, and the third stage are delivered in accordance with a set of therapy parameters for the pulses of each stage that are programmed in response to feedback of the patient so as to provide an effective treatment of the atrial arrhythmia for the patient at a pain sensation in response to the atrial cardioversion therapy that is tolerable to the patient.

17. The method of claim 12, wherein deliver the atrial cardioversion therapy is performed such that the implantable therapy generated is programmed with a heuristic learning algorithm that dynamically modifies a set of therapy parameters for the pulses of each stage in response to an effectiveness of the atrial cardioversion therapy.

18. The method of claim 12, wherein sense and evaluate cardiac signals includes determination of an atrial cycle length and deliver the atrial cardioversion therapy is performed such that a pulse coupling interval of the first stage and the second stage is between 70-100% of an atrial arrhythmia cycle length.

19. The method of claim 12, wherein deliver the atrial cardioversion therapy is performed such that the first stage pulses are at least 10 volts and not more than 100 volts.

20. The method of claim 12, wherein deliver the atrial cardioversion therapy is performed such that the first stage consists of two pulses.

21. The method of claim 12, wherein sense and evaluate cardiac signals includes determination of an atrial cycle length and deliver the atrial cardioversion therapy is performed such that the first stage has a total duration of less than the atrial cycle length.

22. The method of claim 12, wherein deliver the atrial cardioversion therapy is performed such that the first stage pulses comprise biphasic pulses.

23. A method of treating atrial arrhythmias in a patient comprising:

providing an implantable therapy generator, at least one far field electrode and at least two near field electrodes;

providing instructions recorded on a tangible medium for implanting the implantable therapy generator in a patient during a surgical procedure, the instructions including;

implanting the at least one far field electrode and the at least two near field electrodes proximate an atrium of a heart of the patient;

implanting the implantable therapy generator within the patient and coupling the implantable therapy generator to the at least one far field electrode and the at least two near field electrodes; and

causing the implanted atrial arrhythmia treatment apparatus to deliver an atrial arrhythmia therapy which includes a first stage delivered to the at least one far field electrode for unpinning an atrial arrhythmia, a second stage delivered to the at least one far field electrode for anti-repinning of the atrial arrhythmia, and a third stage delivered to the at least two near field electrodes for extinguishing of 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. A method of determining a pain threshold of a patient to atrial arrhythmia therapy, the patient having an implanted atrial arrhythmia treatment apparatus including a first electrode implanted proximate an atrium of a heart of the patient, a second electrode implanted proximate the atrium of the heart of the patient, and a therapy generator implanted in the patient and operably connected to the electrodes, the method comprising:

causing the device to deliver a plurality of stimulations at differing treatment levels;

obtaining an indication from the patient regarding a pain sensation for each of the plurality of stimulations;

programming the therapy generator to deliver an atrial arrhythmia treatment based at least in part on the indications from the patient regarding the pain sensation for each of the plurality of stimulation, the atrial arrhythmia treatment including a first stage configured for unpinning an atrial arrhythmia, a second stage configured for anti-repinning of the atrial arrhythmia, and a third stage configured for extinguishing 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.

25. An implantable therapy generator adapted to be implanted in a patient and operably connected to at least one far field electrode and at least two near field electrodes to sense cardiac signals and deliver atrial arrhythmia therapy to the patient, the implantable therapy generator comprising:

means for evaluating cardiac signals and detecting an atrial arrhythmia; and

means for delivering an atrial cardioversion therapy in response to the atrial arrhythmia, without confirmation of conversion of the atrial arrhythmia during the atrial cardioversion therapy, the atrial cardioversion therapy having at least three stages, including;

a first stage set of pulses delivered via the at least one far field electrode and synchronized to a ventricular refractory period to unpin the atrial arrhythmia;

a second stage set of pulses delivered via the at least one far field electrode to inhibit repinning of the atrial arrhythmia; and

a third stage set of pulses delivered via the at least one near field electrode to extinguish 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.

26. An implantable therapy generator adapted to be implanted in a patient and operably connected to at least one far field electrode and at least two near field electrodes to sense cardiac signals and deliver atrial arrhythmia therapy to the patient, the implantable therapy generator comprising:

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 an atrial cardioversion therapy without confirmation of conversion of the atrial arrhythmia during the atrial cardioversion therapy, the atrial cardioversion therapy having at least three stages including;

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

a second stage set of pulses delivered to the at least one far field electrode to inhibit repinning of the one or more singularities; and

a third stage set of pulses delivered to the at least two near field electrodes 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.