# US 10,441,805 B2 · Method and device for three-stage atrial cardioversion therapy

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- Number: US 10,441,805 B2
- Document ID: US10441805B2
- Status: Granted
- Kind: B2
- Application number: 15/727,803
- Filed: 2017-10-09
- Published: 2018-08-30
- Granted: 2019-10-15
- Earliest claimed: 2007-12-11
- Assignees: Washington University
- Applicants: The Washington University
- Inventors: Igor R. Efimov; Wenwen Li; Ajit Janardhan
- Web page: https://patentgrep.com/patent/US10441805B2

## CPC

- A61N 1/3956: {Implantable devices for applying electric shocks to the heart, e.g. for cardioversion}
- A61N 1/3906: {characterised by the form of the shockwave}
- A61N 1/395: {for treating atrial fibrillation}
- A61N 1/3987: {characterised by the timing or triggering of the shock}
- A61N 1/3624: {occurring in the atrium, i.e. atrial tachycardia}
- A61N: ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY (measurement of bioelectric currents A61B; surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body A61B18/00; anaesthetic apparatus in general A61M; incandescent lamps H01K; infrared radiators for heating H05B)

## 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

### Claim 1

An arrhythmia treatment device comprising:
a plurality of electrodes, wherein the plurality of electrodes includes at least one far-field electrode configured to deliver far-field pulses, and at least one near-field electrode configured to deliver near-field pulses;
sensing circuitry configured to detect one or more cardiac signals;
detection circuitry operably coupled to the sensing circuitry, wherein the detection circuitry is configured to determine an atrial cycle length based on the one or more cardiac signals and to determine existence of atrial arrhythmia based at least in part on the atrial cycle length; and
control circuitry operably coupled to the detection circuitry and to the plurality of electrodes, wherein the control circuitry is configured to initiate delivery of a plurality of pulses when the existence of atrial arrhythmia is determined by the detection circuitry, wherein the plurality of pulses initiated includes:
a first set of pulses configured to be delivered via the at least one far-field electrode;
a second set of pulses configured to be delivered via the at least one far-field electrode; and
a third set of pulses configured to be delivered via the at least one near-field electrode;
wherein the control circuitry is configured to initiate delivery of the second set of pulses 50 to 400 milliseconds after cessation of the first set of pulses and to initiate delivery of the third set of pulses 50 to 400 milliseconds after cessation of the second set of pulses; and
wherein at least one of the first set of pulses, the second set of pulses, or the third set of pulses is delivered without confirmation of conversion of the atrial arrhythmia.

### Claim 2 (depends on 1)

The device of claim 1, further comprising an implantable therapy generator, wherein the implantable therapy generator is configured to act as one of the plurality of electrodes.

### Claim 3 (depends on 1)

The device of claim 1, wherein the first set of pulses includes 2 to 10 biphasic pulses.

### Claim 4 (depends on 1)

The device of claim 1, wherein the first set of pulses includes a plurality of pulses having a voltage amplitude ranging from 10 volts to 100 volts.

### Claim 5 (depends on 1)

The device of claim 1, wherein the first set of pulses is delivered for an amount of time that is less than twice the atrial cycle length.

### Claim 6 (depends on 1)

The device of claim 1, wherein the first set of pulses has a pulse duration of 10 milliseconds or less and a pulse-coupling interval of 20 to 50 milliseconds.

### Claim 7 (depends on 1)

The device of claim 1, wherein one or both of the second set of pulses or the third set of pulses includes 5 to 10 pulses.

### Claim 8 (depends on 1)

The device of claim 1, wherein each of the second set of pulses is 2 volts to 10 volts.

### Claim 9 (depends on 1)

The device of claim 1, wherein each of the second set of pulses is monophasic.

### Claim 10 (depends on 1)

The device of claim 1, wherein one or both of the second set of pulses or the third set of pulses has a pulse-coupling interval of between 70-100% of the atrial cycle length.

### Claim 11 (depends on 1)

The device of claim 1, wherein the third set of pulses is paced at 88% of the atrial cycle length.

### Claim 12 (depends on 1)

The device of claim 1, wherein at least one of the plurality of electrodes is both a far-field electrode and a near-field electrode.

### Claim 13 (depends on 1)

The device of claim 1, further comprising a plurality of capacitors, wherein a first capacitor of the plurality of capacitors is configured to discharge energy for delivery of the first set of pulses, and a second capacitor of the plurality of capacitors is configured to discharge energy for delivery of the second set of pulses, and wherein the first capacitor and the second capacitor are configured to recharge at different times.

### Claim 14

An arrhythmia treatment device comprising:
a plurality of electrodes, wherein the plurality of electrodes includes at least one far-field electrode configured to deliver far-field pulses, and at least one near-field electrode configured to deliver near-field pulses;
sensing circuitry configured to detect one or more cardiac signals;
detection circuitry operably coupled to the sensing circuitry, wherein the detection circuitry is configured to determine existence of atrial arrhythmia based at least in part on the one or more cardiac signals; and
control circuitry operably coupled to the detection circuitry and to the plurality of electrodes, wherein the control circuitry is configured to initiate delivery of a plurality of pulses when the existence of atrial arrhythmia is determined by the detection circuitry, wherein the plurality of pulses initiated includes:
a first set of biphasic pulses having a voltage amplitude ranging from 10 volts to 100 volts that are configured to be delivered via the at least one far-field electrode;
a second set of monophasic pulses ranging from 2 volts to 10 volts that are configured to be delivered via the at least one far-field electrode; and
a third set of pulses configured to be delivered via the at least one near-field electrode;
wherein the control circuitry is configured to initiate delivery of the second set of pulses 50 to 400 milliseconds after cessation of the first set of pulses and to initiate delivery of the third set of pulses 50 to 400 milliseconds after cessation of the second set of pulses.

### Claim 15 (depends on 14)

The device of claim 14, further comprising an implantable therapy generator, wherein the implantable therapy generator is configured to act as one of the plurality of electrodes.

### Claim 16 (depends on 14)

The device of claim 14, further comprising a plurality of capacitors, wherein a first capacitor of the plurality of capacitors is configured to discharge energy for delivery of the first set of pulses, and a second capacitor of the plurality of capacitors is configured to discharge energy for delivery of the second set of pulses, and wherein the first capacitor and the second capacitor are configured to recharge at different times.

### Claim 17 (depends on 14)

The device of claim 14, wherein the detection circuitry is further configured to determine an atrial cycle length based on the one or more cardiac signals and to determine existence of atrial arrhythmia based at least in part on the atrial cycle length, and wherein one or both of the second set of pulses or the third set of pulses has a pulse-coupling interval of between 70-100% of the atrial cycle length.

### Claim 18 (depends on 14)

The device of claim 14, wherein the first set of pulses includes 2 to 10 pulses, and wherein at least one of the second set of pulses or the third set of pulses includes 5 to 10 pulses.

### Claim 19

An arrhythmia treatment device comprising:
a plurality of electrodes, wherein the plurality of electrodes includes at least one far-field electrode configured to deliver far-field pulses, and at least one near-field electrode configured to deliver near-field pulses;
an implantable therapy generator;
sensing circuitry configured to detect one or more cardiac signals;
detection circuitry operably coupled to the sensing circuitry, wherein the detection circuitry is configured to determine existence of atrial arrhythmia based at least in part on the cardiac signals;
control circuitry operably coupled to the detection circuitry and to the plurality of electrodes, wherein the control circuitry is configured to initiate delivery of a plurality of pulses when the existence of atrial arrhythmia is determined by the detection circuitry, wherein the plurality of pulses initiated includes:
a first set of biphasic pulses having a voltage amplitude ranging from 10 volts to 100 volts and configured to be delivered via the at least one far-field electrode; and
a second set of monophasic pulses having a voltage amplitude that is less than that of the first set of biphasic pulses and configured to be delivered via the at least one far-field electrode; and
a plurality of capacitors, wherein a first capacitor of the plurality of capacitors is configured to discharge energy for delivery of the first set of pulses, and a second capacitor of the plurality of capacitors is configured to discharge energy for delivery of the second set of pulses, and wherein the first capacitor and the second capacitor are configured to recharge at different times;
wherein the control circuitry is configured to initiate delivery of the second set of pulses 50 to 400 milliseconds after cessation of the first set of pulses.

### Claim 20 (depends on 19)

The device of claim 19, wherein the first set of pulses includes 2 to 10 pulses, and the second set of pulses includes 5 to 10 pulses.

### Claim 21 (depends on 19)

The device of claim 19, wherein the second set of pulses has a voltage amplitude ranging from 2 volts to 10 volts.
