# US 12,569,690 B2 · Cardiac contractility modulation for atrial arrhythmia patients

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- Number: US 12,569,690 B2
- Document ID: US12569690B2
- Status: Granted
- Kind: B2
- Application number: 17/770,329
- Filed: 2020-10-22
- Published: 2022-12-08
- Granted: 2026-03-10
- Earliest claimed: 2019-10-23
- Assignees: Impulse Dynamics NV
- Applicants: Impulse Dynamics NV
- Inventors: David Prutchi; Simeon Ioannis Kedikoglou; Angela Connolly Stagg; Tamir Ben David
- Web page: https://patentgrep.com/patent/US12569690B2

## CPC

- A61N 1/365: controlled by a physiological parameter, e.g. heart potential {(evoked response A61N1/371)}
- A61N 1/36585: {controlled by two or more physical parameters}
- A61N 1/3624: {occurring in the atrium, i.e. atrial tachycardia}
- A61N 1/3628: {using sub-threshold or non-excitatory signals}
- A61N 1/36592: {controlled by the heart rate variability}
- A61B 5/0245: by using sensing means generating electric signals, {i.e. ECG signals}
- A61B 5/29: for permanent or long-term implantation
- A61N 1/36053: {adapted for vagal stimulation (A61N1/36114 takes precedence)}
- A61N 1/36842: {Multi-site stimulation in the same chamber}
- A61N 1/3962: {in combination with another heart therapy}
- 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)
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)

## Abstract

A cardiac treatment device, including: stimulation circuitry configured to generate a non-excitatory electrical signal which, when applied to ventricular tissue during a ventricular refractory period thereof improves a condition of heart failure in human patients; atrial arrhythmia detection circuitry; and decision circuitry which controls the stimulation circuitry to delivery said signal, also when said atrial arrhythmia detection circuitry detects an atrial arrhythmia.

## Claims

### Claim 1

A cardiac treatment device, comprising:
a stimulation circuitry configured to:
generate a non-excitatory electrical signal, wherein when said signal is configured to be applied to a ventricular tissue during a ventricular refractory period it improves a condition of heart failure in human patients;
an atrial arrhythmia detection circuitry; and
a decision circuitry which controls the stimulation circuitry to deliver said signal during said ventricular refractory period, both when said atrial arrhythmia detection circuitry detects an atrial arrhythmia and when said atrial arrhythmia detection circuitry does not detect said atrial arrhythmia.

### Claim 2 (depends on 1)

A device according to claim 1, wherein said decision circuitry controls modification of at least one parameter of said signal delivered by said stimulation circuitry in response to a detection of said atrial arrhythmia.

### Claim 3 (depends on 2)

A device according to claim 2, wherein said modification comprises increasing a spatial range of tissue stimulated by said signal.

### Claim 4 (depends on 3)

A device according to claim 3, wherein tissue configured to be stimulated by said signal comprises one or more of ventricular septum, right atrium, left atrium, AV node or pulmonary vein's junction with left atria.

### Claim 5 (depends on 1)

A device according to claim 1, wherein said decision circuitry is configured to avoid said delivery if a ventricular arrhythmia is detected.

### Claim 6 (depends on 1)

A device according to claim 1, wherein said decision circuitry is configured to allow said delivery if a supra-ventricular arrhythmia is detected.

### Claim 7 (depends on 1)

A device according to claim 1, wherein said device includes a memory with an indication of a dosage of said signal to be applied and a time duration of application and wherein said decision circuitry is configured to modify an actual duration of signal application according to an actual delivery of signals.

### Claim 8 (depends on 1)

A device according to claim 1, wherein said device is configured to apply said signal also during a non-refractory time in an atria of said patient.

### Claim 9 (depends on 1)

A device according to claim 1, wherein said device has no atrial leads.

### Claim 10 (depends on 1)

A device according to claim 1, wherein said device includes pacing circuitry and wherein said decision circuitry is programmable to selectively prefer applying a non-excitatory signal over applying an increase in pacing in cases of increased cardiac demand.

### Claim 11 (depends on 1)

A device according to claim 1, wherein said atrial arrhythmia detection circuitry detects atrial arrhythmia from signals measured by one or more ventricular leads.

### Claim 12 (depends on 1)

A device according to claim 1, wherein said device has no ventricular stimulation leads.

### Claim 13 (depends on 1)

The cardiac treatment device of claim 1, wherein said non-excitatory electrical signal is configured to be delivered using different parameters when said atrial arrhythmia detection circuitry detects said atrial arrhythmia as compared to when said atrial arrhythmia detection circuitry does not detect said atrial arrhythmia.

### Claim 14

A cardiac treatment device, comprising:
a stimulation circuitry configured to:
generate a non-excitatory electrical signal, wherein when said signal is configured to be applied to a ventricular tissue during a ventricular refractory period it improves a condition of heart failure in human patients;
an atrial arrhythmia detection circuitry; and
a decision circuitry which controls the stimulation circuitry to deliver said signal during said ventricular refractory period regardless of detection of presence or absence of said atrial arrhythmia by said atrial arrhythmia detection circuitry.

### Claim 15

A cardiac treatment device, comprising:
a stimulation circuitry configured to:
generate a non-excitatory electrical signal, wherein when said signal is configured to be applied to a ventricular tissue during a ventricular refractory period it improves a condition of heart failure in human patients;
an atrial arrhythmia detection circuitry;
a memory with a treatment protocol to deliver said non-excitatory electrical signal according to a schedule, and
a decision circuitry which controls the stimulation circuitry to deliver said treatment during said ventricular refractory period, both when said atrial arrhythmia detection circuitry detects an atrial arrhythmia and when said atrial arrythmia detection circuitry does not detect said atrial arrhythmia.

### Claim 16

A method of planning treatment for a patient, comprising:
(a) identifying that a patient has an atrial arrhythmia or a risk to develop thereof; and
(b) planning and implementing a treatment schedule for the patient with an implanted device that generates a non-excitatory electrical signal which, when applied to ventricular tissue during a ventricular refractory period thereof improves a condition of heart failure in human patients, wherein said non-excitatory electrical signal is applied both during an atrial arrhythmia event and in the absence of said atrial arrhythmia event.

### Claim 17 (depends on 16)

A method according to claim 16, wherein said non-excitatory electrical signal is applied during said atrial arrhythmia event with different parameters than when applied in the absence of said atrial arrhythmia event.

### Claim 18 (depends on 16)

A method according to claim 16, comprising selecting said patient and performing said planning with a goal of improving a symptom of said atrial arrhythmia by said treating.

### Claim 19 (depends on 16)

A method according to claim 16, wherein said improving comprises preventing abnormal ventricular activation by said atrial arrhythmia.

### Claim 20 (depends on 16)

A method according to claim 16, wherein said improving comprising reducing said atrial arrhythmia.

### Claim 21 (depends on 16)

A method according to claim 16, wherein said planning comprises planning to apply said non-excitatory signal within 20 mm from a ventricular septum.

### Claim 22 (depends on 16)

A method according to claim 16, wherein said planning comprises planning to apply said non-excitatory signal within an atrium of the heart.

### Claim 23 (depends on 16)

A method according to claim 16, wherein said planning comprises selecting a power level and an application location to stimulate cardiac tissue in both an atria and a ventricle.

### Claim 24 (depends on 16)

A method according to claim 16, wherein said identifying comprises selecting for treatment patients with episodic AF or patients with chronic AF.

### Claim 25 (depends on 24)

A method according to claim 24, wherein said identifying comprises selecting for treatment patients at risk of developing an AA, above 20% in the next year.

### Claim 26 (depends on 24)

A method according to claim 24, wherein said identifying comprises selecting for treatment patients where at least 50% of beats are treatable using said device when considering safety of the patient.

### Claim 27 (depends on 16)

A method according to claim 16, wherein said planning comprises planning with a goal to reduce AF episodes in said patient.

### Claim 28 (depends on 16)

A method according to claim 16, wherein said planning comprises programming the device to apply said signal during a portion of the ventricular refractory period late enough so that said refractory period is extended.

### Claim 29 (depends on 16)

A method according to claim 16, wherein said planning comprises setting up device parameters to apply said signal to above 20,000 treated beats per day, on the average for a month.

### Claim 30 (depends on 16)

The method of claim 16, wherein said non-excitatory electrical signal is delivered using different parameters when applied during the atrial arrhythmia event as compared to when applied in the absence of said atrial arrhythmia event.

### Claim 31

A method of planning treatment for a patient, comprising:
(a) identifying that a patient has an atrial arrhythmia or a risk to develop thereof; and
(b) planning and implementing a treatment schedule for the patient with an implanted device that generates a non-excitatory electrical signal which, when applied to ventricular tissue during a ventricular refractory period thereof improves a condition of heart failure in human patients, wherein said non-excitatory electrical signal is applied regardless of detection of presence or absence of an event of said atrial arrhythmia.

### Claim 32

A method of planning treatment for a patient, comprising:
(a) identifying that a patient has an atrial arrhythmia or a risk to develop thereof; and
(b) planning and implementing a treatment schedule for the patient with an implanted device that generates a non-excitatory electrical signal which, when applied to ventricular tissue during a ventricular refractory period thereof improves a condition of heart failure in human patients, wherein said treatment schedule is a prophylactic treatment according to a schedule, wherein said non-excitatory electrical signal is applied according to said prophylactic treatment schedule, wherein the non-excitatory electrical signal is applied both during an atrial arrhythmia event and in the absence of said atrial arrhythmia event.
